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Body: | 5816 Federal Register
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Vol. 84, No. 36
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Friday, February 22, 2019
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Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 261, 262, 264, 265, 266,
268, 270, and 273
[EPA-HQ-RCRA-2007-0932; FRL-9988-26-
OLEM]
RIN 2050-AG39
Management Standards for Hazardous
Waste Pharmaceuticals and
Amendment to the P075 Listing for
Nicotine
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: Some pharmaceuticals are
regulated as hazardous waste under the
Resource Conservation and Recovery
Act (RCRA) when discarded. This final
rule adds regulations for the
management of hazardous waste
pharmaceuticals by healthcare facilities
and reverse distributors. Healthcare
facilities (for both humans and animals)
and reverse distributors will manage
their hazardous waste pharmaceuticals
under this new set of sector-specific
standards in lieu of the existing
hazardous waste generator regulations.
Among other things, these new
regulations prohibit the disposal of
hazardous waste pharmaceuticals down
the drain and eliminates the dual
regulation of RCRA hazardous waste
pharmaceuticals that are also Drug
Enforcement Administration (DEA)
controlled substances. The new rules
also maintain the household hazardous
waste exemption for pharmaceuticals
collected during pharmaceutical take-
back programs and events, while
ensuring their proper disposal. The new
rules codify Environmental Protection
Agency (EPA)'s prior policy on the
regulatory status of nonprescription
pharmaceuticals going through reverse
logistics. Additionally, EPA is excluding
certain U.S. Food and Drug
Administration (FDA) approved over-
the-counter (OTC) nicotine replacement
therapies (NRTs) from regulation as
hazardous waste and is establishing a
policy on the regulatory status of unsold
retail items that are not pharmaceuticals
and are managed via reverse logistics,
fulfilling the commitment we made in
the Retail Strategy of September 2016.
DATES: This final rule is effective on
August 21, 2019.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA-HQ-RCRA-2007-0932. All
documents in the docket are listed on
the https://www.regulations.gov
website. Although listed in the index,
some information is not publicly
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
FOR
FURTHER
INFORMATION
CONTACT:
Kristin Fitzgerald, Materials Recovery
and Waste Management Division, Office
of Resource Conservation and Recovery
(5304P), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone
number: (703) 308-8286; email address:
Fitzgerald.Kristin@epa.gov, or Brian
Knieser, Materials Recovery and Waste
Management Division, Office of
Resource Conservation and Recovery
(5304P), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone
number: (703) 347-8769; email address:
Knieser.Brian@epa.gov. Also see the
EPA's website at https://www.epa.gov/
hwgenerators/management-
pharmaceutical-hazardous-waste.
SUPPLEMENTARY
INFORMATION:
Table of Contents
The information presented in this
preamble is organized as follows:
I. General Information
A. Does this action apply to me?
B. What action is the Agency taking?
C. What is the Agency's statutory authority
for taking this action?
D. What are the incremental costs and
benefits of this action?
II. List of Acronyms
III. Rationale for the Final Rule
IV. Background
A. Summary of the Proposal
B. Retail Sector Notice of Data Availability
(NODA)
C. Retail Strategy
D. EPA Inspector General Report
V. Amendment to the Acute Hazardous
Waste Listing for Nicotine and Salts
(Hazardous Waste No. P075)
A. Background
B. Summary of the Proposal
C. Summary of Comments
D. Final Rule Provisions
E. Comments and Responses
VI. Reverse Distribution and Reverse
Logistics
A. Summary
B. Background
C. EPA's Proposed Regulations for Reverse
Distribution of Pharmaceuticals
D. EPA's Final Reverse Distribution
Regulation and Reverse Logistics Policy
E. Applicability of the Household
Hazardous Waste Exemption to Retail
Items
VII. Scope of the Final Rule
A. What facilities are subject to the final
rule?
B. What facilities are not subject to the
final rule?
C. Scope of Hazardous Wastes Addressed
by This Final Rule
D. Wastes Generated at Healthcare
Facilities That Are Not Included in the
Scope of this Final Rule
VIII. What terms are defined in this final
rule? (§
266.500)
A. Definition of Pharmaceutical
B. Definition of Hazardous Waste
Pharmaceutical
C. Definition of Reverse Distributor
D. Definition of Potentially Creditable
Hazardous Waste Pharmaceutical
E. Definition of Non-Creditable Hazardous
Waste Pharmaceutical
F. Definition of Evaluated Hazardous
Waste Pharmaceutical
G. Definition of Household Waste
Pharmaceutical
H. Definition of Non-Hazardous Waste
Pharmaceutical
I. Definition of Non-Pharmaceutical
Hazardous Waste
J. Definition of Healthcare Facility
K. Definition of Long-Term Care Facility
IX. Applicability (§
266.501)
A. What facilities are subject to the final
rule?
B. What facilities or pharmaceuticals are
not subject to the final rule?
(§§
266.501(c) and 266.501(f) and
266.501(g))
C. Do Not Count Hazardous Waste
Pharmaceuticals Managed Under
Subpart P Toward Determining
Generator Category (§§
262.13(c)(9))
X. Standards for Healthcare Facilities That
Manage Non-Creditable Hazardous
Waste Pharmaceuticals (§
266.502)
A. Notification/Withdrawal Requirements
for Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(a))
B. Personnel Training Requirements for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(b))
C. Healthcare Facilities Making a
Hazardous Waste Determination for Non-
Creditable Pharmaceuticals (§
266.502(c))
D. No Central Accumulation Area and
Satellite Accumulation Area
Requirements for Healthcare Facilities
Managing Non-Creditable Hazardous
Waste Pharmaceuticals
E. Container Standards for Healthcare
Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals
(§
266.502(d))
F. Labeling Standards on Containers for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(e))
G. Accumulation Time Limits for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(f))
H. Land Disposal Restrictions for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(g) and
§
266.502(d)(4))
I. Procedures for Healthcare Facilities
Managing Rejected Shipments of Non-
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EPA-HQ-RCRA-2007-0932.
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(h))
J. Reporting Requirements for Healthcare
Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals
(§
266.502(i))
K. Recordkeeping Requirements for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(j))
L. Response to Spills for Healthcare
Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals
(§
266.502(k))
M. Management of Non-Creditable
Hazardous Waste Pharmaceuticals by
Long-Term Care Facilities That Collect
Them From Individuals Who Self-
Administer
N. Healthcare Facilities That Accept
Hazardous Waste Pharmaceuticals From
Off-Site Very Small Quantity Generator
Healthcare Facilities (§
266.502(l))
XI. Standards for Healthcare Facilities That
Accumulate Potentially Creditable
Hazardous Waste Pharmaceuticals Prior
to Shipment To Reverse Distributors
(§
266.503)
A. Healthcare Facilities Making a
Hazardous Waste Determination for
Potentially Creditable Pharmaceuticals
(§
266.503(a))
B. Accepting Potentially Creditable
Hazardous Waste Pharmaceuticals From
an Off-Site Healthcare Facility That is a
Very Small Quantity Generator
(§
266.503(b))
C. Accumulation Time, Container
Management and Labeling for Healthcare
Facilities Managing Potentially
Creditable Hazardous Waste
Pharmaceuticals
D. No Biennial Reporting for Potentially
Creditable Hazardous Waste
Pharmaceuticals Generated at Healthcare
Facilities (§
266.503(d))
E. Recordkeeping Requirements for
Healthcare Facilities Managing
Potentially Creditable Hazardous Waste
Pharmaceuticals (§
266.503(e))
F. Response to Spills for Healthcare
Facilities Managing Potentially
Creditable Hazardous Waste
Pharmaceuticals (§
266.503(f))
XII. How does this rule apply to healthcare
facilities that are very small quantity
generators for both their hazardous waste
pharmaceuticals and their non-
pharmaceutical hazardous waste?
(§
266.504)
A. Very Small Quantity Generators Using
Reverse Distributors (§
266.504(a))
B. Off-Site Collection of Hazardous Waste
Pharmaceuticals Generated by
Healthcare Facilities (§
266.504(b))
C. Long-Term Care Facilities That Are Very
Small Quantity Generators Can Dispose
Hazardous Waste Pharmaceuticals in
Drug Enforcement Administration
Collection Receptacles (§
266.504(c))
D. Long-Term Care Facilities With 20 Beds
or Fewer Are Presumed To Be Very
Small Quantity Generators (§
266.504(d))
XIII. Sewer Disposal Prohibition (§
266.505)
A. Regulatory Background on the Domestic
Sewage Exclusion
B. Summary of Proposal
C. Summary of Comments
D. Final Rule Provisions
E. Comments and Responses
XIV. Conditional Exemptions for Hazardous
Waste Pharmaceuticals That Are Also
Drug Enforcement Administration
Controlled Substances and Household
Waste Pharmaceuticals Collected in
Take-Back Programs (§
266.506)
A. Summary of Proposal
B. Summary of Comments
C. Final Rule Provisions
D. Comments and Responses
XV. Management of Residues in
Pharmaceutical Containers (§
266.507)
A. Regulatory Background
B. Stock, Dispensing and Unit-Dose
Containers (§
266.507(a))
C. Syringes (§
266.507(b))
D. Other Containers, Including Delivery
Devices (§
266.507(c) & (d))
XVI. Shipping Standards for Hazardous
Waste Pharmaceuticals (§§
266.508 and
266.509)
A. Shipping Non-Creditable Hazardous
Waste Pharmaceuticals From Healthcare
Facilities to Treatment, Storage, and
Disposal Facilities (§
266.508(a))
B. Shipping Evaluated Hazardous Waste
Pharmaceuticals From Reverse
Distributors to Treatment, Storage, and
Disposal Facilities (§
266.508(a))
C. Shipping Non-Creditable or Evaluated
Hazardous Waste Pharmaceuticals for
Import or Export (§§
266.508(b) and
266.508(c))
D. Shipping Potentially Creditable
Hazardous Waste Pharmaceuticals
(§
266.509)
XVII. Standards for Reverse Distributors
(§
266.510)
A. Background on Reverse Distributor
Operations
B. EPA's Rationale for Finalizing New
RCRA Management Standards for
Reverse Distributors
C. Detailed Discussion of Final Reverse
Distributor Standards
XVIII. Amendments to the Part 268
Prohibitions on Storage
XIX. Implementation and Enforcement
A. Healthcare Facilities
B. Reverse Distributors and Reverse
Logistics Centers
C. Healthcare Facilities and Reverse
Distributors Managing Non-
Pharmaceutical Hazardous Waste in
Accordance With 40 CFR Part 262 or Part
273 (i.e., Complying With ''More Than
One RCRA'')
D. State Enforcement Activities and
Interpretations
E. Intersection of Part 266 Subpart P With
the Hazardous Waste Generator
Improvements Rule
XX. State Authorization
A. Applicability of Rules in Authorized
States
B. Effect on State Authorization
C. Effect on State Authorization in States
That Have Added Pharmaceuticals to the
Universal Waste Program
XXI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
C. Paperwork Reduction Act
D. Regulatory Flexibility Act
E. Unfunded Mandates Reform Act
F. Executive Order 13132: Federalism
G. Executive Order 13175: Consultation
With Tribal Governments
H. Executive Order 13045: Children's
Health
I. Executive Order 13211: Energy Supply
J. National Technology Transfer and
Advancement Act
K. Executive Order 12898: Environmental
Justice
L. Congressional Review Act
I. General Information
A. Does this action apply to me?
This final rule applies to healthcare
facilities that generate, accumulate, or
otherwise handle hazardous waste
pharmaceuticals and reverse
distributors engaged in the management
of prescription hazardous waste
pharmaceuticals. The list of North
American Industry Classification
System (NAICS) codes for the
potentially affected entities, other than
RCRA transfer, storage, and disposal
facilities (TSDFs), are presented in
Table 1. More detailed information on
the potentially affected entities is
presented in sections VII and IX of this
preamble and the Regulatory Impact
Analysis (RIA) which is available in the
docket for this final rule.
1
TABLE
1-NAICS CODES
OF
ENTITIES
POTENTIALLY
AFFECTED
BY
THIS
FINAL
RULE: HEALTHCARE
FACILI-
TIES
AND
REVERSE
DISTRIBUTORS
NAICS codes
Description of NAICS
code
4242
.......................
Drug Wholesalers.
44511
.....................
Supermarkets and
Other Grocery (ex-
cept convenience)
Stores.
44611
.....................
Pharmacies and Drug
Stores.
452311
...................
Warehouse Clubs and
Supercenters.
54194
.....................
Veterinary Services.
6211
.......................
Physicians' Offices.
6212
.......................
Dentists' Offices.
6213
.......................
Other Health Practi-
tioners (e.g., chiro-
practors).
6214
.......................
Outpatient Care Cen-
ters.
6219
.......................
Other Ambulatory
Health Care Serv-
ices.
622
.........................
Hospitals.
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Rules and Regulations
2
September 25, 2015; 80 FR 58014.
3
See the Regulatory Impact Analysis for the final
rule in the rulemaking docket EPA-HQ-RCRA-
2007-0932.
TABLE
1-NAICS CODES
OF
ENTITIES
POTENTIALLY
AFFECTED
BY
THIS
FINAL
RULE: HEALTHCARE
FACILI-
TIES
AND
REVERSE
DISTRIBUTORS-
Continued
NAICS codes
Description of NAICS
code
6231
.......................
Nursing Care Facilities
(e.g., assisted living
facilities, nursing
homes).
623311
...................
Continuing Care Retire-
ment Communities
(e.g., assisted living
facilities with on-site
nursing facilities).
Various NAICS
.......
Reverse Distributors.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities potentially
impacted by this action. This table lists
examples of the types of entities EPA
knows could potentially be affected by
this action. Other types of entities not
listed could also be affected. To
determine whether your entity,
company, business, organization, etc., is
affected by this action, you should
examine the applicability criteria in this
rule. If you have questions regarding the
applicability of this action to a
particular entity, consult the person
listed in the preceding FOR
FURTHER
INFORMATION
CONTACT
section of this
document.
B. What action is the Agency taking?
On September 25, 2015, EPA
proposed new regulations under part
266 subpart P for the management of
hazardous waste pharmaceuticals by
healthcare facilities and reverse
distributors.
2
This final rule
promulgates part 266 subpart P.
However, in response to public
comments, we have made a number of
changes to the proposed rulemaking.
The comments and the changes are
discussed in detail below. When this
final rule becomes effective in their
states, a process that is explained in
section XX of this preamble, healthcare
facilities and reverse distributors must
manage their hazardous waste
pharmaceuticals under this new set of
regulations in part 266 subpart P in lieu
of operating under part 262 as they have
been. These operating standards include
a prohibition on the sewering of
hazardous waste pharmaceuticals. Part
266 subpart P also includes a
conditional exemption for hazardous
waste pharmaceuticals that are also
identified as controlled substances by
the Drug Enforcement Administration
(DEA). Further, subpart P redefines
when containers that held hazardous
waste pharmaceuticals are considered
''RCRA empty.'' Healthcare facilities
that are very small quantity generators
(VSQGs) must comply with the sewer
prohibition for their hazardous waste
pharmaceuticals under part 266 subpart
P and have the option of complying
with the entire subpart in lieu of
operating under the conditional
exemption of §
262.14.
EPA is also taking two actions in
addition to promulgating part 266
subpart P. First, this final rule amends
the P075 acute hazardous waste listing
for nicotine and salts to indicate that
U.S. Food and Drug Administration
(FDA)-approved over-the counter (OTC)
nicotine replacement therapies (NRTs)
are not included in the listing. Second,
the preamble to this final rule also
establishes EPA's policy on the
regulatory status of unsold retail items,
including nonprescription
pharmaceuticals, managed at reverse
logistics centers, fulfilling the
commitment we made in the Retail
Strategy of September 2016.
Although the proposed rulemaking
sought comment on ideas for how to
expand the universe of pharmaceuticals
that are hazardous waste, this final rule
does not add pharmaceuticals to the
hazardous waste listings or expand the
hazardous waste characteristics to
include additional pharmaceuticals. At
the time of proposal, we indicated that
any action to expand the universe of
hazardous waste pharmaceuticals would
be part of a separate, future action.
Note that throughout the preamble
and the RIA for this final rule, the terms
''EPA,'' ''Agency'' and ''we'' are used
interchangeably.
C. What is the Agency's statutory
authority for taking this action?
These regulations are promulgated
under the authority of §§
2002, 3001,
3002, 3004, and 3018 of the Solid Waste
Disposal Act (SWDA) of 1970, as
amended by the Resource Conservation
and Recovery Act (RCRA) of 1976, as
amended by the Hazardous and Solid
Waste Amendments of 1984 (HSWA), 42
U.S.C. 6912, 6921, 6922, 6924, and
6939.
D. What are the incremental costs and
benefits of this action?
As discussed in section XXI, the
Regulatory Impact Analysis (RIA) for
this rule estimates the annualized cost
to industry to comply with the
requirements is between $6.59 and
$7.99 million (at a 7 percent discount
rate).
3
The streamlined management
standards for healthcare facilities and
the regulatory relief in regard to FDA-
approved OTC NRT products (i.e.,
patches, gums and lozenges) is
estimated to result in an annualized
cost-savings of between $19.58 and
$22.95 million (at a 7 percent discount
rate). This results in a net annualized
cost savings for the rule of $12.99 to
$14.96 million at a 7 percent discount
rate.
The provisions of the final rule are
expected to improve regulatory clarity
and reduce regulatory burden. As an
example of the increased regulatory
clarity and certainty provided in the
rule, EPA eliminated the dual regulation
of RCRA hazardous waste
pharmaceuticals that are also DEA
controlled substances by finalizing a
conditional exemption. Additionally, to
the extent that the rule reduces
concentrations of hazardous waste
pharmaceuticals in surface and drinking
waters, this rule may result in improved
ecosystems and human health
outcomes. Ideally, the Agency would
prefer to quantify and monetize the
rule's human health benefits. However,
only some categories of cost savings are
quantifiable; sufficient data are not
available to support a detailed
quantitative analysis for many benefit
categories. In these cases, the benefits
are described qualitatively.
II. List of Acronyms
3PL
Third Party Logistics Provider
AARP
American Association of Retired
Persons
AEA
Atomic Energy Act
API
Active Pharmaceutical Ingredient
ASHP
American Society of Hospital
Pharmacists
BDAT
Best Demonstrated Available
Technology
BR
Biennial Report
CAA
Central Accumulation Area
CCP
Commercial Chemical Product
CERCLA
Comprehensive Environmental
Response, Compensation and Liability Act
CFR
Code of Federal Regulations
CISWI
Commercial, Industrial Solid Waste
Incinerator
CMS
Centers for Medicare and Medicaid
Services
CPSC
Consumer Product Safety
Commission
CWA
Clean Water Act
DEA
Drug Enforcement Administration
DOE
Department of Energy
DOT
Department of Transportation
DSCSA
Drug Supply Chain Security Act
DQSA
Drug Quality and Security Act
EPA
Environmental Protection Agency
E.O.
Executive Order
FDA
Food and Drug Administration
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4
See 79 FR 8926; February 14, 2014 for the Retail
NODA. Also see the associated docket EPA-HQ-
RCRA-2012-0426 for public comments.
5
EPA Inaction in Identifying Hazardous Waste
Pharmaceuticals May Result in Unsafe Disposal,
Report No. 12-P-0508, dated May 25, 2012). For a
copy of the report, please see: https://www.epa.gov/
sites/production/files/2015-10/documents/
20120525-12-p-0508.pdf or see the docket for this
final rule: EPA-HQ-RCRA-2007-0932-0177.
6
81 FR 85735; November 28, 2016, Hazardous
Waste Generator Improvements Final Rule.
7
P-listed hazardous waste residues in containers
are themselves considered P-listed hazardous
wastes (see §
261.33(c)), unless the container is
considered ''RCRA empty'' either by undergoing
triple-rinsing with an appropriate solvent; or
cleaning with a method that has been proven in
scientific literature or tests conducted by the
generator to achieve equivalent removal (see
§
261.7(b)(3)).
8
On November 4, 2011, ORCR issued a memo to
the Regional RCRA Division Directors highlighting
three acceptable approaches, beyond triple-rinsing
containers, that healthcare facilities can employ
when managing P-listed container residues. Please
see: Memo from Suzanne Rudzinski to RCRA
Division Directors (RCRA Online #14827). As
discussed in section XV of this preamble, this final
rule supersedes this memo.
FD&C
Act Federal Food, Drug, and
Cosmetic Act
FR
Federal Register
HIPAA
Health Insurance Portability and
Accountability Act
HMIWI
Hospital, Medical, Infectious Waste
Incinerator
HSWA
Hazardous and Solid Waste
Amendments
LQG
Large Quantity Generator
LTCF
Long-term Care Facility
LTCP
Long-term Care Pharmacy
MSWLF
Municipal Solid Waste Landfill
MWC
Municipal Waste Combustor
NAICS
North American Industry
Classification System
NIOSH
National Institute for Occupational
Safety and Health
NODA
Notice of Data Availability
NPRM
Notice of Proposed Rulemaking
NRC
Nuclear Regulatory Commission
NRT
Nicotine Replacement Therapy
OIG
Office of Inspector General
OLEM
Office of Land and Emergency
Management
OMB
Office of Management and Budget
ONDCP
Office of National Drug Control
Policy
OSHA
Occupational Safety and Health
Administration
OSWER
Office of Solid Waste and
Emergency Response
OSWI
Other Solid Waste Incinerators
OTC
Over-the-counter
POTW
Publicly Owned Treatment Works
RCRA
Resource Conservation and Recovery
Act
SAA
Satellite Accumulation Area
SQG
Small Quantity Generator
SWDA
Solid Waste Disposal Act
TC
Toxicity Characteristic
TCLP
Toxicity Characteristic Leaching
Procedure
TSDF
Treatment, Storage and Disposal
Facility
VSQG
Very Small Quantity Generator
III. Rationale for the Final Rule
The impetus behind this final rule is
to address the various concerns raised
by stakeholders regarding the difficulty
in implementing the RCRA Subtitle C
hazardous waste regulations for the
management of hazardous waste
pharmaceuticals generated at healthcare
facilities. EPA has met with various
stakeholders to learn about compliance
challenges and has received input from
stakeholders through more formal
mechanisms. For instance, when EPA
solicited stakeholder input in a notice of
data availability (NODA) and request for
comment, ''Hazardous Waste
Management and the Retail Sector:
Providing and Seeking Information on
Practices to Enhance Effectiveness to the
Resource Conservation and Recovery
Act Program'' (''Retail NODA''), retailers
submitted comments detailing
compliance challenges with hazardous
waste pharmaceuticals in their stores.
4
Further, EPA's Office of Inspector
General (OIG) published a report citing
the need to clarify how hazardous waste
pharmaceuticals are regulated (for more
information on the Retail NODA and the
OIG report, see section VI of this
preamble).
5
The Retail NODA and the
OIG Report, along with input from
healthcare facilities and retailers,
identified a number of ways in which a
healthcare facility differs from a
manufacturing facility when it comes to
applying the RCRA Subtitle C program
to the generation and management of
hazardous waste pharmaceuticals.
First, under the current hazardous
waste regulatory scheme, healthcare
personnel, whose primary focus is to
provide care for patients, are typically
responsible for making hazardous waste
determinations since they are at the
point of generation (e.g., a patient's
bedside). Yet, healthcare personnel,
such as nurses and doctors, do not
typically have the expertise to make
hazardous waste determinations. In
general, healthcare personnel are not
prepared to assume hazardous waste
management responsibilities, nor is it
EPA's expectation that they assume
primary hazardous waste management
responsibilities. EPA recognizes this
challenge and provides a framework
through this final rule that allows
healthcare personnel to focus on
healthcare while still ensuring that
hazardous waste is directed to proper
management.
Second, in the healthcare setting, a
wide variety of hazardous waste
pharmaceuticals are generated in
relatively small quantities by a number
of different employees across the
facility. This situation differs from a
typical manufacturing facility where
fewer employees in a few locations
generate comparatively much larger
volumes of a smaller range of hazardous
wastes. Data from the Biennial Report
(BR) show that in 2013, approximately
46 percent of large quantity generators
(LQGs) generated between one and five
waste streams.
6
Further, a typical
manufacturing facility generates a more
predictable set of hazardous waste
streams. In contrast, a healthcare facility
can have thousands of items in its
inventory at any one time and these may
vary over time, based on the needs of
the patients. In addition,
pharmaceutical wastes come in many
different forms, such as tablets (pills),
transdermal patches, lozenges, gums,
creams, and liquids, and are delivered
by a variety of devices, such as
nebulizers, intravenous (IV) tubing,
syringes, etc. The combination of having
thousands of different pharmaceutical
products and little expertise in
hazardous waste regulations makes it
difficult for healthcare personnel to
make appropriate hazardous waste
determinations when pharmaceuticals
are disposed.
Third, several of the hazardous waste
pharmaceuticals that are generated by
healthcare facilities are P-listed acute
hazardous wastes (see §
261.33(e)),
which are regulated with more stringent
requirements at much smaller amounts.
If a facility generates more than 1 kg of
acute hazardous waste per calendar
month, it is regulated more rigorously as
an LQG. Aside from the
pharmaceuticals themselves, residues
within pharmaceutical containers that
contained P-listed commercial chemical
products (CCPs) must be managed as
acute hazardous waste even if the
pharmaceutical was fully administered,
unless the container is RCRA-empty
(e.g., by triple-rinsing the container).
7
Triple rinsing can be impractical with
certain medical devices, such as
syringes and paper cups, so healthcare
facilities often manage these containers
as hazardous waste, which can result in
being subject to the most stringently
regulated generator category (i.e., LQG).
8
To facilitate compliance among
healthcare facilities and to respond to
these concerns, EPA is finalizing a new
set of sector-specific regulations to
improve the management and disposal
of hazardous waste pharmaceuticals at
healthcare facilities.
In addition to improving compliance
and responding to stakeholder concerns,
the Agency has three additional goals
for this final rule. The first is to reduce
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9
See the Clean Water Act regulations of 40 CFR
403.5(b)(1) and (7).
10
C.G. Daughton, I.S. Ruhoy, Environmental
footprint of pharmaceuticals: The significance of
factors beyond direct excretion to sewers, Environ.
Toxicol. Chem., 28 (2009), pp. 2495-2521, 10.1897/
08-382.1.
11
See the docket for this rulemaking EPA-HQ-
RCRA-2007-0932-0169.
12
California SB-423. http://
leginfo.legislature.ca.gov/faces/
billTextClient.xhtml?bill_id=201520160SB423.
13
https://www.dtsc.ca.gov/HazardousWaste/
Retail_Industry/upload/SB423_Final-Rpt.pdf.
14
73 FR 73520; December 2, 2008.
the amount of pharmaceuticals that are
disposed of down the drain. Studies
have found that many healthcare
facilities, particularly long term-care
facilities, are using drain disposal (e.g.,
flushing) as a routine disposal method
for pharmaceutical wastes, including
those that are hazardous waste. Until
this final rule, drain disposal has been
an allowable disposal method for
hazardous waste pharmaceuticals under
RCRA (however, since 1990, the Clean
Water Act regulations have prohibited
the drain disposal of ignitable wastes
and those wastes that result in toxic
gases, vapors of fumes within the
publicly owned treatment works.)
9
Although pharmaceuticals are thought
to be primarily entering the
environment through excretion,
reducing intentional sewer disposal is
one mechanism to help reduce the
environmental loading of
pharmaceuticals into our Nation's
waters.
10
See section XIII for more
information about how this final rule
reduces sewer disposal and
pharmaceuticals in water.
The second goal is to address the
overlap between EPA's RCRA hazardous
waste regulations and the DEA
regulations for controlled substances.
Some stakeholders have indicated that
hazardous waste pharmaceuticals that
are also controlled substances are
stringently regulated and therefore are
expensive to manage and dispose of in
accordance with both sets of
regulations. In addition, stakeholders
have indicated that the RCRA hazardous
waste pharmaceuticals that are also DEA
controlled substances are most likely to
be sewer disposed to avoid the costs of
compliant incineration. EPA eliminates
this regulatory overlap in this final rule,
as it has been an unnecessary burden for
healthcare facilities. Additionally, we
expect that eliminating the overlap will
help reduce intentional sewer disposal
of pharmaceuticals.
The third goal is to clarify the
regulatory status of a major practice
used by healthcare facilities, including
retailers in particular, for the
management of unused and/or expired
pharmaceuticals, known as reverse
distribution (see section VI for a
detailed discussion of reverse
distribution). A number of states have
taken enforcement actions against
retailers that have raised awareness
about the reverse distribution of
pharmaceuticals. In particular,
California has taken numerous
enforcement actions against national
retail chains with pharmacies for not
complying with the RCRA hazardous
waste regulations. In recent years, the
state took enforcement actions and
imposed fines on the following chains:
Kmart (2009), Walmart (2010), Target
(2011), CVS (2012), Costco (2012),
Walgreens (2012), Rite-Aid (2013), and
Safeway (2015). In at least two
settlement agreements, California
directed the defendants (CVS and
Costco) to ''initiate work with
appropriate stakeholders from business
and government, including the U.S.
Environmental Protection Agency, the
U.S. Food and Drug Administration, and
the DTSC [Department of Toxic
Substances Control], and thereafter
either directly or through trade
associations or informal coalitions of
interested parties, undertake to promote
federal regulatory reform regarding the
proper management of non-dispensable
pharmaceuticals, including OTC
medications, through 'reverse
distribution.'
''
11
Through these
settlement agreements, California is
seeking clarity from EPA about its
longstanding interpretation about the
regulatory status of pharmaceuticals that
are routed through pharmaceutical
reverse distribution systems.
Additionally, the California
legislature directed the DTSC to
convene a Retail Waste Working Group
with the aim of developing
recommendations to the legislature for
how to address many retail waste issues,
including reverse distribution/
logistics.
12
The Retail Waste Working
Group, which consisted of large
retailers, small retailers, district
attorneys, certified unified program
agencies, non-government
organizations, local governments, other
relevant state agencies as determined by
DTSC (such as the California
Department of Public Health, and the
California Department of Resources
Recycling and Recovery),
manufacturers, reverse distributors, and
other interested stakeholders, produced
their final report in August 2017.
13
Although the group was convened by
and reported to the California
legislature, its membership was drawn
from across the country. EPA
participated in an observer role, but
neither contributed to developing
recommendations nor to writing the
group's report. The group's work has
highlighted the need for a national
policy in this area.
IV. Background
A. Summary of the Proposal
On September 25, 2015, EPA
proposed to add subpart P under 40 CFR
part 266 (see 80 FR 58014). Part 266 is
entitled ''Standards for the Management
of Specific Hazardous Wastes and
Specific Types of Hazardous Waste
Management Facilities.'' In this new
subpart P, we proposed a tailored,
sector-specific regulatory framework for
managing hazardous waste
pharmaceuticals at healthcare facilities
and reverse distributors. We proposed
that healthcare facilities that are small
quantity generators (SQGs) or LQGs and
all reverse distributors, regardless of
their RCRA generator category, would
be required to manage their hazardous
waste pharmaceuticals under subpart P
of 40 CFR part 266, instead of the
generator regulations in 40 CFR part
262. The standards were not proposed
as a voluntary or optional alternative to
managing hazardous waste
pharmaceuticals under 40 CFR part 262;
they were proposed as mandatory
standards.
We discuss the proposed provisions
in greater detail in subsequent sections
of the preamble, but offer a brief
summary of the proposal here. For
healthcare facilities, we proposed
different management standards for
non-creditable and potentially
creditable hazardous waste
pharmaceuticals. We proposed that non-
creditable hazardous waste
pharmaceuticals (i.e., those that are not
expected to be eligible to receive
manufacturer credit) would be managed
on site at the healthcare facility similar
to how they would have been under a
previous proposal for managing these
wastes: The 2008 Universal Waste
proposal for pharmaceutical waste.
14
We proposed that when shipped off site,
the non-creditable hazardous waste
pharmaceuticals must be transported as
hazardous wastes, including the use of
the hazardous waste manifest, and sent
to a RCRA-designated facility, such as
an interim status or permitted TSDF.
Additionally, we proposed to revise our
policy regarding pharmaceuticals going
through reverse distribution (i.e., those
which are ''potentially creditable'') such
that they would be considered
hazardous wastes at the healthcare
facility. However, given the value
associated with these potentially
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15
The final rule defines an ''evaluated hazardous
waste pharmaceutical'' as a prescription hazardous
waste pharmaceutical that has been evaluated by a
reverse distributed in accordance with
§
266.510(a)(3) and will not be sent to another
reverse distributor for further evaluation or
verification of manufacturer credit.
16
February 14, 2014; 79 FR 8926.
17
See 83 FR 11654; March 16, 2018.
18
EPA Inaction in Identifying Hazardous Waste
Pharmaceuticals May Result in Unsafe Disposal,
Report No. 12-P-0508, dated May 25, 2012). For a
copy of the report, please see: https://www.epa.gov/
sites/production/files/2015-10/documents/
20120525-12-p-0508.pdf or see the docket for this
final rule: EPA-HQ-RCRA-2007-0932-0177.
19
OSWER has since been renamed the Office of
Land and Emergency Management (OLEM).
20
For a copy of OSWER's full response to OIG,
please see: http://www.epa.gov/oig/reports/2012/12-
P-0508_Agency%20Response.pdf.
creditable hazardous waste
pharmaceuticals, EPA proposed
flexibilities for some of the regulatory
requirements. For instance, we
proposed that healthcare facilities
would continue to be allowed to send
potentially creditable hazardous waste
pharmaceuticals to reverse distributors
for them to be evaluated for
manufacturer credit. After considering
comments received on the prior
Universal Waste proposal regarding the
lack of tracking of shipments, EPA's
2015 proposed standards included
provisions to ensure the safe, secure and
documented delivery of the potentially
creditable hazardous waste
pharmaceuticals to reverse distributors.
Under the proposal, reverse
distributors would no longer be
regulated under 40 CFR part 262 as
hazardous waste generators, nor would
they be regulated under 40 CFR parts
264, 265, and 270 as TSDFs. Rather, the
proposal established a new category of
hazardous waste entity, called
pharmaceutical reverse distributors.
EPA also proposed that reverse
distributors would have different
standards for those hazardous waste
pharmaceuticals destined for another
reverse distributor (and still considered
potentially creditable hazardous waste
pharmaceuticals) versus those that are
destined for a TSDF (considered to be
evaluated hazardous waste
pharmaceuticals.)
15
The proposed
standards for pharmaceutical reverse
distributors were, in many respects,
similar to the LQG standards, but with
additional standards to respond to
concerns expressed by commenters to
the proposal to add pharmaceuticals to
the Universal Waste program.
EPA proposed several additional
standards that apply to both healthcare
facilities and reverse distributors. First,
EPA proposed to prohibit healthcare
facilities and reverse distributors from
disposing of hazardous waste
pharmaceuticals down a toilet or drain
(i.e., flushed or sewered). Second, EPA
proposed that hazardous waste
pharmaceuticals managed under subpart
P would not be counted toward
calculating the site's generator category.
Third, EPA proposed a conditional
exemption for hazardous waste
pharmaceuticals that are also DEA
controlled substances. Fourth, EPA
proposed management standards for
determining when a container with
hazardous waste pharmaceutical
residues is considered RCRA empty.
B. Retail Sector Notice of Data
Availability (NODA)
In 2014, EPA published a NODA for
the Retail Sector, in which the Agency
requested, among other things, comment
on a series of topics related to retail
operations in order to better understand
the issues retail stores face in complying
with RCRA regulations.
16
Many retail
commenters to the NODA mentioned
that because nicotine is an acute
hazardous waste (P075), retailers are
considered LQGs when they discard
more than 1 kg per month of unused
nicotine-containing products (e.g., e-
cigarettes and smoking cessation
products such as gums, patches and
lozenges). Retailers discard these
products mainly because they are either
expired or they are returned by
customers and the retailer does not
restock them due to safety concerns. In
comments to the NODA, retailers urged
the EPA to provide some regulatory
relief with regard to nicotine-containing
products. See section V of this preamble
for a discussion of EPA's amendment of
the acute hazardous waste listing for
nicotine and salts (P075).
C. Retail Strategy
On September 12, 2016, as a follow-
up to the comments we received on the
Retail NODA, EPA released its Retail
Strategy. In the strategy, EPA committed
to two sets of activities. First, we
committed to completing rulemakings
that were already underway, that,
although were not specifically
developed with retail in mind,
contained provisions that might be
helpful in resolving some issues that
retailers faced in complying with RCRA
regulations. This included completing
the 2016 Hazardous Waste Generator
Improvements final rule and the
Hazardous Waste Pharmaceuticals final
rule. Second, we committed to three
new activities that specifically address
concerns identified by commenters.
First, EPA committed to developing
guidance on aerosol cans. Second, EPA
committed to exploring the potential for
adding certain retail items, such as
aerosol cans, pesticides, and/or
electronics, to the federal universal
waste regulations. A proposed
rulemaking for adding aerosol cans to
the federal universal waste regulations
was published in Federal Register on
March 16, 2018.
17
Third, EPA
committed to developing a policy that
addresses the reverse distribution
process for the retail sector as a whole.
This policy is articulated in detail in
section VI of the preamble of this final
rule.
D. EPA Inspector General Report
On May 25, 2012, the EPA's Office of
Inspector General (OIG) issued the
report, ''EPA Inaction in Identifying
Hazardous Waste Pharmaceuticals May
Result in Unsafe Disposal.''
18
The OIG
reviewed EPA's process for identifying
and listing pharmaceuticals as
hazardous wastes. Because of this
review, the OIG provided the following
recommendations to the Assistant
Administrator for the Office of Solid
Waste and Emergency Response
(OSWER):
19
(1) Identify and review existing
pharmaceuticals to determine whether they
qualify for regulation as hazardous waste.
(2) Establish a process to review new
pharmaceuticals to determine whether they
qualify for regulation as hazardous waste.
(3) Develop a nationally consistent
outreach and compliance assistance plan to
help states address challenges that healthcare
facilities, and others as needed, have in
complying with RCRA regulations for
managing hazardous waste pharmaceuticals.
As detailed in OSWER's response to
OIG, this final rule fulfills our obligation
for addressing the third
recommendation.
20
In the preamble to
the proposed rulemaking we solicited
comment as part of our ongoing efforts
to identify additional pharmaceuticals
as hazardous wastes. EPA does not
address the OIG's first two
recommendations as part of this final
rulemaking directly. That said, the
Agency believes that provisions in the
final rule, such as the streamlined
standards for healthcare facilities and
the elimination of LQG status for the
management of hazardous waste
pharmaceuticals, address the first two
recommendations indirectly by
encouraging healthcare facilities to
manage their non-hazardous waste
pharmaceuticals as hazardous waste
pharmaceuticals.
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21
See 45 FR 33124, May 19, 1980.
22
See pp. 21-22 and 33 in Background Document
dated April 1981 in the docket for this rulemaking
EPA-HQ-RCRA-2007-0932-0171.
23
See letter from Robert Dellinger, USEPA to
Charlotte Smith, WM Healthcare Solutions, Inc.,
dated August 23, 2010, RCRA Online #14817.
V. Amendment to the Acute Hazardous
Waste Listing for Nicotine and Salts
(Hazardous Waste No. P075)
A. Background
In 1980, EPA promulgated the P- and
U-lists of CCPs or manufacturing
chemical intermediates that are
hazardous wastes if they are discarded
or intended to be discarded (40 CFR
261.33(e) and (f)). Several hundred CCPs
were listed on the P- and U-lists,
including nicotine and salts.
21
The
phrase ''commercial chemical product
or manufacturing chemical
intermediate'' refers to a ''chemical
substance which is manufactured or
formulated for commercial or
manufacturing use which consists of the
commercially pure grade of the
chemical, any technical grades of the
chemical that are produced or marketed,
and all formulations in which the
chemical is the sole active ingredient''
(see the comment following 40 CFR
261.33(d)).
The P-listed chemicals are identified
as acute hazardous wastes and U-listed
chemicals are identified as non-acute
hazardous wastes when discarded in
unused form. EPA listed nicotine and
salts (referred to commonly as just
nicotine) as acute hazardous waste P075
in 261.33(e). A chemical substance is
listed in 40 CFR 261.33(e) as an acute
hazardous waste if it meets any of the
criteria in 40 CFR 261.11(a)(2), which,
as described below, are based on human
toxicity data, or dose of a chemical
given orally or dermally that is lethal to
50 percent of the test animals (LD50), or
the concentration of a chemical in the
air that is lethal to 50 percent of the test
animals (LC50). That is, when the solid
waste ''has been found to be fatal to
humans in low doses or, in the absence
of data on human toxicity, it has been
shown in studies to have an oral LD50
toxicity (rat) of less than 50 milligrams
per kilogram, an inhalation LC50
toxicity (rat) of less than 2 milligrams
per liter, or a dermal LD50 toxicity
(rabbit) of less than 200 milligrams per
kilogram or is otherwise capable of
causing or significantly contributing to
an increase in serious irreversible, or
incapacitating reversible, illness.''
EPA listed nicotine as an acute
hazardous waste based on an estimated
oral LD50 toxicity to humans of 1 mg/
kg and a dermal LD50 toxicity to rabbits
of 50 mg/kg. The acute toxicity criterion
for humans, as discussed above, is ''fatal
to humans in low doses'' (see
§
261.11(a)(2)).
EPA's Background Document from
April 1981 prepared in support of the
commercial chemical product
hazardous waste listings in §
261.33
provides a basis for what is meant by
''fatal to humans in low doses'' for
chemicals that have been given through
the oral route: ''fatal to humans upon
ingestion of ≤100 mg/kg''.
22
This
Background Document cites an
estimated oral LD50 toxicity to humans
for nicotine and salts as 1 mg/kg, which
corresponds to 50-60 mg of nicotine as
a lethal dose for an adult weighing 50-
60 kg, and this estimated LD50 value
falls within the criterion for ''fatal to
humans in low doses.'' However, the
Background Document does not provide
any information regarding the nicotine
product or concentration of nicotine
that was used to establish this estimated
oral LD50 toxicity in humans for
nicotine. According to comments
submitted to EPA on the proposal by the
retailers, tobacco companies, and trade
associations, the only nicotine products
being marketed at the time when EPA
listed nicotine were pesticides
containing up to 40 percent nicotine
sulfate. These commenters note that the
low-concentration nicotine-containing
products (specifically smoking cessation
or NRT products) had not yet been
developed and, therefore, were not
considered when EPA listed nicotine as
an acute hazardous waste.
Once the Agency lists chemicals on
either the P- or U-lists, these chemicals
are P- or U-listed hazardous wastes
when discarded or intended to be
discarded regardless of chemical
concentrations, with two exceptions:
Warfarin and salts (which are listed as
waste number P001 when present at
concentrations greater than 0.3% and
U248 when present at concentrations of
0.3% or less) and zinc phosphide
(which is listed as Waste Code P122
when present at concentrations greater
than 10% and Waste Code U249 when
present at concentrations of 10% or
less). Therefore, the P075 hazardous
waste listing is applicable to the
commercial chemical product nicotine
or a commercial chemical product
containing nicotine as the sole active
ingredient when disposed regardless of
the concentration of nicotine. The
Agency has previously stated that
unused dermal patches containing
nicotine, nicotine gum, and nicotine
lozenges are listed hazardous waste
P075 when discarded.
23
The Agency
stated this because nicotine is a listed
hazardous waste P075 when discarded,
and nicotine is the sole active ingredient
in patches containing nicotine, nicotine
gum, and nicotine lozenges. However,
once the nicotine patches, gums, and
lozenges have been used for their
intended purpose, regardless of the
length of use, they are no longer
commercial chemical products and
would not be listed hazardous waste
P075 when discarded.
B. Summary of Proposal
In the preamble to the proposed
rulemaking, EPA provided a rationale
for why it is considering the possibility
of amending the P075 acute hazardous
waste listing for nicotine and salts.
Primarily, the retail associations,
representing a broad range of retailers
within the retail industry, asked EPA to
undertake a rulemaking to remove low-
concentration nicotine products from
the P075 hazardous waste listing under
RCRA. This is because the retailers did
not believe their low-concentration
nicotine products meet RCRA's
requirements for acute hazardous waste,
when discarded. Thus, according to the
retailers, the acute hazardous waste
classification for their discarded low-
concentration nicotine products is
inappropriately making them subject to
RCRA's LQG requirements. (for more
information, see 80 FR 58071;
September 25, 2015). Consequently,
EPA, in the preamble to the proposed
rulemaking, presented and sought
comment on two possible approaches
for amending the acute hazardous waste
listing for nicotine and salts and stated
that, depending on the information
received during the comment period,
EPA could finalize one of them. Under
the first approach, EPA would exempt
FDA-approved OTC nicotine-containing
smoking cessation products (nicotine
patches, gums, and lozenges) from the
P075 hazardous waste listing if toxicity
information received or collected for
these products supported a finding that
these products, when disposed, do not
warrant regulation as acute hazardous
wastes under RCRA Subtitle C. We note
that this preamble will collectively refer
to nicotine patches, gums, and lozenges
as FDA-approved OTC NRTs. EPA also
stated in the preamble to the proposed
rulemaking that e-cigarettes would not
be exempted under this approach,
because they have not been approved by
FDA and the concentration of nicotine
in e-cigarettes is not limited by
regulation (for more information, see
discussion under Comments and
Responses included later in this
section). Under the second approach,
EPA would establish a concentration-
based exemption from the P075 listing
for low-concentration nicotine-
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https://www.surgeongeneral.gov/library/
reports/50-years-of-progress/full-report.pdf.
25
https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3880486/.
containing products (including e-
cigarettes); in other words, a maximum
concentration of nicotine in these
products below which the P075 listing
would not apply. This approach would
require submission to EPA of supporting
human toxicological data or animal
LD50 data for these products at the
maximum concentration of nicotine
found in these products.
C. Summary of Comments
The comments received were mainly
from retailers, tobacco companies,
individual states, trade and government
associations. The retailers, tobacco
companies, and trade associations
supported an exemption from the P075
hazardous waste listing for FDA-
approved OTC NRTs. In addition, these
commenters also generally favored an
exemption from the P075 listing for all
other nicotine-containing products
which they considered to have low
nicotine concentrations, including e-
cigarettes and e-liquids. Alternatively, if
the EPA decided not to exempt all low-
concentration nicotine-containing
products from the P075 listing, the
commenters indicated they would
support the reclassification of such
products as non-acute (i.e., U-listed)
hazardous wastes or otherwise require
these products to be managed as
hazardous waste pharmaceuticals under
40 CFR part 266 subpart P. These
commenters stated that classification of
low-concentration nicotine-containing
products as acute hazardous waste is
unjustified. The commenters also
expressed a concern that, because of this
inappropriate classification, anyone
generating more than 1 kg per month of
this acute hazardous waste becomes
subject to RCRA's LQG regulations,
which result in increased economic
burdens and reporting requirements.
The commenters asserted that the
original P075 listing was likely based on
a concentration of nicotine that is orders
of magnitude greater than today's low-
concentration NRTs, and the human
toxicity data that EPA relied upon to
support the original P075 listing have
been recently reassessed and could not
be substantiated. They stated further
that a U.S. Surgeon General's Report
issued in 2014 could not find support
for the 1 mg/kg median lethal dose for
humans used to support the original
listing.
Additionally, the retailers, tobacco
companies, and the trade associations
commented that EPA listed nicotine and
salts as P075 acutely toxic hazardous
wastes long before NRT products were
in use and thus EPA did not consider if
they presented a risk that should be
covered by the P075 listing. According
to these commenters, because the OTC
NRTs (nicotine patches, gums, and
lozenges) contain very low
concentrations of nicotine, they clearly
do not meet EPA's listing criteria for
acute toxicity and in addition have been
approved by FDA to be sold to the
public over-the-counter (meaning these
products can be purchased without a
prescription). In summary, these
commenters urged EPA to amend the
P075 listing to exempt the low-
concentration nicotine-containing
products based on either (1) type of
product and/or (2) a specified
concentration of nicotine in these
products below which the product
would be exempt, because there are no
credible toxicity data that would
support keeping low-concentration
nicotine-containing products listed as
acute hazardous wastes.
All of the states and one government
association (Northeast Waste
Management Officials' Association or
NEWMOA) that submitted comments on
the proposal generally supported
exempting FDA-approved OTC NRTs
from the P075 listing, if EPA obtained
the necessary toxicity data to show that
these products are not acutely toxic.
These same commenters, except for one
(Oklahoma), did not support exempting
e-cigarettes or nicotine-containing e-
liquids from the P075 listing. Almost all
of the states and NEWMOA wanted
continued regulation of e-cigarettes and
nicotine-containing e-liquids because
the safety of these products is less
widely accepted.
In summary, the Agency did not
receive any comments that disagreed
with the proposed approach to exempt
FDA-approved OTC NRTs from the
P075 listing, provided this approach is
supported by sufficient toxicity
information to conclude that
concentrations of nicotine contained in
these products are not acutely toxic.
D. Final Rule Provisions
The Agency is finalizing the first
approach for amending the P075 listing
discussed in preamble of the proposal.
That is, EPA is amending the hazardous
waste listing for hazardous waste
number (commonly called ''hazardous
waste code'') P075 in §
261.33(e) to
exempt FDA-approved OTC NRTs.
Specifically, the P075 listing for
nicotine is being amended with a
parenthetical phrase stating that the
listing does not include patches, gums,
and lozenges that are FDA-approved
over-the-counter nicotine replacement
therapies.
The Agency has concluded that FDA-
approved OTC NRTs do not meet the
acute listing criteria under 40 CFR
261.11(a)(2), based on review of
available toxicity information for
nicotine and nicotine-containing FDA-
approved OTC NRTs (see discussion
under Comments and Responses below).
E. Comments and Responses
1. Nicotine Toxicity Data
Some commenters stated that human
toxicity data that EPA originally relied
upon to list nicotine as P075 acutely
toxic hazardous wastes are not credible
and do not support classifying low-
concentration nicotine-containing
products as acutely toxic hazardous
wastes. In addition, they also stated that
available animal toxicity data do not
support classifying low-concentration
nicotine-containing products as acutely
toxic hazardous wastes. The
commenters provided references to
several recent reports and an article (see
discussion of these references in the
following paragraphs) to support their
assertions. The commenters stated that
these recent reports and article provide
evidence that nicotine is not as toxic as
originally thought.
Commenters argued that the validity
of an estimated oral LD50 toxicity to
humans of 1 mg/kg (corresponding to
50-60 mg of nicotine as a lethal dose for
an adult weighing 50-60 kg) for nicotine
used by EPA to support the acute
hazardous waste listing for nicotine has
been questioned by government entities
and researchers, most recently by the
U.S. Surgeon General's Report, ''The
Health Consequences of Smoking-50
Years of Progress'' (2014)
24
and in an
article published in Archives of
Toxicology, ''How much nicotine kills a
human? Tracing back the generally
accepted lethal dose to dubious self-
experiments in the nineteenth century''
(Mayer, 2014).
25
The U.S. Surgeon
General's Report cited by commenters
states that the toxicity of nicotine is
dependent on dose, dose duration and
frequency, route of exposure,
formulation of the nicotine product, and
interpersonal variability. This report
also states that numerous poisonings
have been documented in the literature
since the use of nicotine as a pesticide
became widespread in the early part of
twentieth century; however, there has
not been a systematic assessment of the
literature to characterize the dose-
response relationship. Furthermore,
based on an extensive literature search,
the report states that no study was
located as a source for the 50-60 mg
estimated dose that is commonly
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26
See ECHA's Committee for Risk Assessment
Opinion Proposing Harmonized Classification and
Labeling at EU Level of Nicotine, adopted 10
September 2015 (https://echa.europa.eu/
documents/10162/23665416/clh_opinion_nicotine_
5579_en.pdf/0103fadb-e945-4839-c4f4-
17d20854adf0).
27
See P.9 of RAI's comments dated December 23,
2015 in the docket for this rulemaking EPA-HQ-
RCRA-2007-0932-0329.
28
https://www.fda.gov/Drugs/ResourcesForYou/
SpecialFeatures/ucm342560.htm.
29
See 78 FR 19718; April 2, 2013.
30
See FDA materials for New Drug Application
Numbers 21-330 and 22-360 in the docket for this
rulemaking EPA-HQ-RCRA-2007-0932.
reported to be fatal to humans. Finally,
according to the report, the literature
has also shown that in one case a
relatively large dose of 240 mg nicotine
administered to a patient accidently did
not prove to be fatal.
The Mayer article cited by
commenters also points out that fatal
nicotine intoxications are relatively rare
and that there are countless records of
subjects who have survived
consumption of nicotine in amounts far
higher than 60 mg. One example
referenced by Mayer in his article was
a person surviving following a suicide
attempt with 4 grams (4000 milligrams)
of pure nicotine. Mayer asserts that this
example and many other literature
reports on nonfatal nicotine poisonings
show that the oral LD50 toxicity of
nicotine to humans of 1 mg/kg does not
appear to be reliable. Although Mayer
did not conduct any lab testing on
nicotine, he uses previously reported
nonfatal poisonings to develop an
estimate of the oral LD50 toxicity of
nicotine to humans in the range of 6.5-
13 mg/kg (based on an adult weight of
50-60 kg, this would correspond to an
estimated range of 325-780 mg of
nicotine as the lethal dose for adults).
Mayer concludes that nicotine is less
toxic than originally thought. That said,
his new estimate of the oral LD50
toxicity of nicotine to humans still falls
well within the range of ≤ 100 mg/kg,
which was one of the reasons for listing
nicotine and salts as P075 acute
hazardous waste.
EPA regulations in §
261.11(a)(2) state
that, in the absence of adequate human
toxicity data, the criteria for identifying
acute toxicity should be based on the
toxicity of the materials to laboratory
animals. Commenters directed us to a
recently-issued report summarizing
available toxicity information on
nicotine by the Committee for Risk
Assessment of the European Chemicals
Agency (ECHA).
26
The acute toxicity of
nicotine to laboratory animals presented
in the report issued by the Committee
for Risk Assessment in comparison to
the regulatory criteria for these animals
presented in 40 CFR 261.11(a)(2) are as
follows: The acute oral LD50 for rat is
in the range of 52.5-70 mg/kg (ECHA)
compared to the acute oral LD50
regulatory criterion for rat of < 50 mg/
kg (§
261.11(a)(2)). The acute oral LD50
values for rats reported by ECHA fall
just outside the acute toxicity criterion
in EPA's regulations. The acute dermal
LD50 for rabbit is 70.4 mg/kg (ECHA)
compared to acute dermal LD50
regulatory criterion for rabbit of < 200
mg/kg (§
261.11(a)(2)). The acute dermal
LD50 for rabbit falls well below the
acute toxicity criterion in our
regulations. There were no comparable
data available for the acute inhalation
LC50 for rat.
Based on the toxicity information
discussed above, and the listing criteria
in 40 CFR 262.11(a)(2), the evidence is
clear that nicotine is still acutely toxic
to both humans and animals under the
RCRA hazardous waste regulations and
must continue to be listed as acute
hazardous waste number P075 under
§
261.33(e). As already noted, under the
hazardous waste regulations the Agency
generally lists commercial chemical
products, if they are discarded or
intended to be discarded, regardless of
chemical concentrations. However, EPA
is not precluded from amending
(through rulemaking) an existing listing,
for example, if a particular subset of
wastes within that listing can be
identified as not posing the risk for
which the original listing was
established.
2. Food and Drug Administration-
Approved Nicotine Replacement
Therapies
A number of commenters urged EPA
to exempt low-concentration nicotine-
containing products (specifically OTC
NRTs) from the P075 listing. The
commenters stated that millions of
people use OTC NRTs daily without
showing any signs of acute toxicity, and
these products have been approved by
FDA to be sold over the counter without
a prescription. Therefore, they believe
this is the best evidence that these
products are not acutely toxic and safe
for people to use.
As noted above, the Agency stated in
the proposal that if it obtained toxicity
data to support the conclusion that
FDA-approved OTC NRTs do not meet
the criteria for listing as an acutely
hazardous waste, then it will exempt
these products from the P075 listing.
The FDA-approved OTC NRTs are
designed to help people quit smoking by
delivering controlled amounts of
nicotine to ease symptoms of
withdrawal and craving. The Consumer
Health Products Association stated in its
comments that nicotine gums and
lozenges contain 2-4 mg nicotine
(approximately 0.2-2 percent by weight
depending on lozenge size) and nicotine
patches contain 7 mg, 14 mg, or 21 mg
of nicotine (approximately 2-7 percent
by weight). Comments from Reynolds
American Inc. Services Company (RAI
Services or RAI) provided similar
information on the amount of nicotine
in these FDA-approved OTC NRTs.
27
According to information on FDA's
website, FDA regulations ensure that
OTC drug products are safe and
effective for people to use.
28
In most
cases, OTC drug products are regulated
by FDA through OTC drug monographs.
OTC drug monographs state the active
ingredients and other conditions of use
(including dose, dosage form, and route
of administration) that are generally
recognized as safe and effective to treat
certain diseases or conditions without a
prescription. OTC drug products that
conform to a final monograph and other
relevant requirements are not required
to be reviewed by FDA before
marketing. Products that do not conform
to a final monograph must be reviewed
under the new drug application process.
The new drug application process is
how manufacturers provide evidence to
FDA to demonstrate that the new drug
product is safe and effective for use as
recommended in the product's labeling.
Sometimes, an OTC drug product begins
as an approved prescription drug and
then a drug company will submit an
application to FDA to switch the drug
product from prescription status to OTC
status. FDA reviews the information in
the application, along with information
about adverse events associated with the
use of the drug, and determines whether
the prescription drug can be used safely
and effectively as an OTC drug. FDA
allowed nicotine patches and gums,
which were initially available by
prescription only, to be switched to
OTC status between 1996 and 2002. The
nicotine lozenge and mini-lozenge were
approved by FDA directly for OTC use
in 2002 and 2009 via new drug
applications.
29
30
FDA has determined that OTC NRTs
can be used safely and effectively by
people without a healthcare
professional's supervision when used in
accordance with their label instructions.
Since FDA first approved NRTs for OTC
use, FDA has reviewed a number of
studies that examined use of OTC NRTs,
including use of OTC NRTs in
combination with other nicotine-
containing products, use of OTC NRTs
at higher than standard-dose, and use of
OTC NRTs over periods longer than
recommended, and it has not identified
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31
See 78 FR 19718; April 2, 2013.
32
See pages 5 and 6 of the Pharmacology Review
for the New Drug Application Number 21-330 in
the docket for this rulemaking EPA-HQ-RCRA-
2007-0932.
33
International Journal of Health Sciences
(Qassim). ''Nicotine Replacement Therapy: An
Overview'' (July, 2016) 10(3): pp. 425-435.
34
See the following four FDA documents
included in the docket for this rulemaking EPA-
HQ-RCRA-2007-0932: (1) Letter from Janet
Woodcock responding to a citizen petition, dated
June 4, 2015; (2) Memo from Kellie Taylor et al. on
citizen petition response, dated May 8, 2015; (3)
Memo from Joslyn Swann providing a review of
Abuse, Misuse, and Overdose associated with
Nicotine Replacement Therapy products, dated
October 1, 2010; and (4) Nicoderm OTC Switch
Medical Officer Review (NDA 20-165), dated
August 7, 1995.
35
See letter from Barnes Johnson, USEPA to Scott
DeMuth, g
2
Revolution, LLC., dated May 8, 2015,
RCRAOnline #14851.
36
See the docket for this rulemaking EPA-HQ-
RCRA-2007-0932-0392.
any significant safety concerns.
31
It is
useful to recognize one characteristic of
FDA-approved OTC NRTs when
considering the toxicity of nicotine
contained in these products, which is
that they are designed for controlled
release of nicotine to approximate the
nicotine amounts obtained from
smoking. This characteristic of FDA-
approved OTC NRTs means that
nicotine enters the body over a period
of time and there is a gradual increase
in the level of nicotine in the blood
when used in accordance with the
accompanying label. According to EPA's
review of FDA information and RAI's
comments, FDA's Center for Drug
Evaluation and Research reviewed
pharmacology and toxicology data for
nicotine polacrilex lozenges and made a
number of observations concerning
nicotine's toxicology. FDA stated that
''oral doses of nicotine that have been
reported to be lethal in animals are
approximately 8- to 150-fold greater
than nicotine exposures that would
result from use of Nicotine Polacrilex
Lozenges.'' In addition, the FDA noted
that ''the toxicological profile of
nicotine in animals has been largely
superseded by the extensive human
experience with this agent. Based on the
established clinical experience with
similar nicotine replacement therapy
products, acute toxic reactions would
not be anticipated from use of Nicotine
Polacrilex Lozenges at the
recommended dosage.''
32
In summary, the most common dosage
of nicotine from OTC nicotine gums and
lozenges (2-4 mg) and OTC nicotine
patches (7-21 mg) is absorbed slowly
and results in significantly lower
concentrations of nicotine in blood
levels compared to the amount of
nicotine that has been determined or
estimated to be lethal to animals and
humans. The OTC nicotine patch, the
strongest of which contains 114 mg of
nicotine, delivers 21 mg of nicotine at
a relatively steady rate over a 24-hour
period when the patch is applied to the
skin. The most frequently reported side
effects from use of patches are local skin
reactions, which can be reduced by
moving the site of the patch application
daily as instructed.
33
In addition, FDA
has reviewed and approved these
products as being safe and effective for
people to use without a prescription.
Furthermore, the FDA-approved OTC
NRTs have been in the market for over
two decades and although some serious
adverse events have been reported,
based on the available information, EPA
has concluded that the serious adverse
events do not meet EPA's criteria for
acute toxicity under 40 CFR 261.11(a)(2)
(i.e., fatal to humans in low doses or
capable of causing or significantly
contributing to an increase in serious
irreversible, or incapacitating reversible,
illness).
34
Finally, the serious adverse
events that have been reported have not
caused FDA to reverse its decision to
allow the NRTs to be sold as OTCs.
Therefore, the Agency finds that FDA-
approved OTC NRTs are not acutely
toxic and is exempting them from the
P075 listing.
The FDA-approved OTC NRTs, prior
to the effective date of this rule, were
listed hazardous waste P075 when
discarded. Therefore, these wastes have
been required to be managed under
RCRA Subtitle C hazardous waste
regulations. Following exemption from
the P075 listing, these OTC NRT wastes
will be considered non-hazardous
wastes and can be managed under
applicable non-hazardous solid waste
regulations. The Agency does not have
any information at this time to suggest
that these wastes will be improperly
managed as non-hazardous wastes or
have the potential to cause human or
environmental exposures. The Agency
believes, because of the low
concentrations of nicotine in these
wastes and their design to slowly
release the nicotine, any risk from
plausible mismanagement scenarios
would not be sufficient to cause a
substantial present or potential hazard
to human health or the environment.
Nevertheless, the Agency encourages
healthcare facilities to first consider if
their unused nicotine-containing
products, which are to be discarded, can
be legitimately recycled to recover the
nicotine. The Agency has recently stated
to one recycler that legitimately
recycled nicotine-containing products
would not be considered solid waste
and thus would not be subject to RCRA
hazardous waste regulation.
35
In
addition, the Agency reminds
healthcare facilities, especially retail-
sector pharmacies, who may decide to
discard expired FDA-approved OTC
NRTs in their dumpsters or regular
trash, that products' labels direct them
to ensure that these products are kept
out of the reach of children and pets.
Therefore, the Agency recommends that
healthcare facilities, including retailers,
take the necessary security measures to
discard unused, unwanted, or expired
OTC NRTs where they are not freely
accessible to the public. The
recommended security measures could
be simple as having locks on the
dumpsters and trash cans that are used
for discarding OTC NRTs or placing the
dumpsters and trash cans in locked
areas.
3. E-Cigarettes, E-Liquids, and
Prescription Nicotine Replacement
Therapies
There were mixed comments on
exempting e-cigarettes, nicotine
containing e-liquids, and NRTs
requiring a prescription from the P075
hazardous waste listing when discarded
(for more information, see Summary of
Comments included previously in this
section). The comments from retailers,
tobacco companies, and trade
associations generally favored
exempting these categories of products
from the P075 listing when discarded,
whereas comments from four of five
states and NEWMOA did not support
exempting these products from the P075
listing when discarded.
The e-cigarettes and nicotine-
containing e-liquids (or just e-liquids)
are currently not regulated by FDA in
the same manner as NRTs. NRTs are
regulated as drugs by FDA while e-
cigarettes and e-liquids are regulated as
tobacco products by FDA.
Consequently, the FDA has not been
able to evaluate the health risks to the
public from e-cigarettes and e-liquids to
the same extent as it has been able to for
drugs. Moreover, the concentrations of
nicotine in e-cigarettes and e-liquids are
not limited by any FDA regulation or
approval process and are therefore
unpredictable. The supplemental
comments on the proposal submitted to
EPA by the Retail Associations (June 29,
2016)
36
stated that a recent
promulgation of a final rule by FDA
referred to as the ''Deeming Rule'' (81
FR 28973; May 10, 2016) will ensure
against ''unpredictable'' nicotine
concentrations in e-cigarette products
and, therefore, strengthens the case for
reclassification or exemption of these
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http://pediatrics.aappublications.org/content/
early/2016/05/05/peds.2016-0041?utm_
source=TrendMD&utm_medium=TrendMD&utm_
campaign=Pediatrics_TrendMD_1.
38
https://www.healthychildren.org/English/
safety-prevention/at-home/Pages/Liquid-Nicotine-
Used-in-E-Cigarettes-Can-Kill-Children.aspx.
39
https://www.fda.gov/drugs/resourcesforyou/
consumers/ucm143547.htm.
40
See the docket for this rulemaking EPA-HQ-
RCRA-2007-0932-0398.
products from the P075 listing. The
Deeming Rule extended FDA's
regulatory authority to all tobacco
products, including electronic nicotine
delivery systems (or e-cigarettes). This
rule allows FDA to evaluate factors such
as ingredients (e.g., nicotine and its
concentration), product design, and
health risks to both users and non-users.
The Deeming Rule ensures that newly
regulated tobacco products, before they
are introduced into the market, meet
certain requirements, including warning
labels, prohibiting sales to minors,
registering with FDA, and obtaining
marketing authorization from FDA. It is,
however, important to note that FDA's
review and approval process for
introducing new tobacco products to the
market is not as rigorous in assessing
their safe use as review and approval of
drug products. Furthermore, in August
2017, the FDA extended the compliance
deadline for the newly regulated
noncombustible tobacco products in the
Deeming Rule, such as e-cigarettes, from
November 8, 2017 to August 8, 2022.
Therefore, without controls on the
concentration of nicotine in e-cigarettes
and e-liquids or FDA's approval of these
products as being safe and effective for
people to use, the Agency lacks
adequate information and certainty to
conclude that these nicotine-containing
products will not pose the risks similar
to those for which the P075 listing was
established. For all of the above reasons,
at this time the Agency cannot support
exempting e-cigarettes and nicotine-
containing e-liquids from the P075
listing.
Furthermore, in the short time that e-
cigarettes have been in the U. S.
marketplace (since about 2007), the calls
to poison control centers related to
exposures to this product, mostly among
young children, have increased
substantially. This significant increase
can be attributed largely to the rapid rise
in the use of e-cigarettes by the public.
According to an article published in the
Journal Pediatrics, ''Pediatric Exposure
to E-Cigarettes, Nicotine, and Tobacco
Products in the United States'' (May
2016), the monthly number of exposures
among young children (younger than six
years old) associated with e-cigarettes
increased by almost 1500 percent from
January 1, 2012 (14 exposures) to April
30, 2015 (223 exposures).
37
During the
same period, children under two years
old accounted for 44.1 percent of the
exposures associated with e-cigarettes.
Exposures of children to unregulated
nicotine concentrations in e-cigarette
cartridges and refill solutions (e-liquids)
have the potential to cause much more
severe toxic effects compared to
exposures of children to FDA-approved
OTC NRTs. This is because e-liquid
refill containers are available in
concentrations up to 100 mg/mL that are
then diluted before use. The liquid
nicotine, ingested or absorbed through
skin, is likely to result in more severe
toxic effects because it is available in
higher concentrations and absorbed
rapidly by the body. In December 2014,
a 1-year old child died from liquid
nicotine poisoning, the first such death
in the U.S.
38
Prescription NRTs, like OTC NRTs,
must be approved for use by FDA as
drugs. However, the FDA considers OTC
drug products to be safe enough to take
without the guidance of a health
professional. A prescription for a drug is
written by a health professional for an
individual at a specific dose after the
health professional has diagnosed an
illness. Generally, nicotine-containing
prescription drugs (e.g., nicotine inhaler
and nicotine spray) contain an aqueous
solution intended for administration as
a metered spray, which means, in
comparison to FDA-approved OTC
NRTs, nicotine can be delivered rapidly
to the body. When a prescription
pharmaceutical is transitioned to OTC
status, the key question for FDA is
whether consumers can achieve the
desired medical result without the
intervention of a health care
professional and without endangering
their safety.
39
For example, FDA has to
review information about adverse events
and serious adverse events resulting
from use of a prescription drug before it
can make a determination on whether a
prescription drug is safe to switch over
to an OTC drug. FDA has not yet made
that determination for the existing
prescription NRTs and EPA also did not
receive any toxicity or health effects
information on prescription NRTs.
Prescription NRTs are also expected to
be used less frequently than FDA-
approved OTC NRTs, and, thus, should
not exist in the same quantities at
retailers as FDA-approved OTC NRTs.
Furthermore, prescription NRTs are not
expected to be returned to retailers like
FDA-approved OTC NRTs, because they
are prescribed by health professionals
for specific individuals and can't be
resold once dispensed. Therefore, the
comments from retailers also expressed
less concern about the disposal of
prescription NRTs causing a change in
their hazardous waste generator
category.
Based on the information discussed
above and the comments from a
majority of the states and NEWMOA,
the Agency is not exempting e-
cigarettes, e-liquids, or prescription
NRTs from the P075 hazardous waste
listing. The Agency believes that any
plausible mismanagement or diversion
of these waste products, if exempted
and allowed to be managed as non-
hazardous wastes, has the ability to
cause substantial present or potential
hazard to human health and the
environment. This is because
prescription NRT products can contain
nicotine at much higher concentrations
and in a more readily available form
(i.e., in liquid and mist), which acts
faster on the body, than the nicotine
contained in FDA-approved OTC NRTs.
Instead, the Agency is allowing e-
cigarettes, e-liquids, and prescription
NRTs to be managed as hazardous waste
pharmaceuticals under 40 CFR part 266
subpart P when they are discarded.
4. Concentration-Based Exemption
Some commenters stated that the data
and information they provided to EPA
should be adequate to support a
concentration-based exemption for
nicotine-containing products. These
commenters requested that EPA exempt
from the P075 listing all present and
future nicotine-containing products
with less than a particular nicotine
concentration (e.g., less than 3% or 5%).
The Agency stated in the proposal
that it would consider a concentration-
based exemption for low-concentration
nicotine-containing products if
toxicology data (e.g., animal LD50 data)
for nicotine-containing products at
maximum concentration of nicotine in
these products became available. On
June 9, 2017, Perrigo submitted
additional comments along with oral
and dermal LD50 toxicity studies for
nicotine gums and lozenges
manufactured by Perrigo.
40
The gums
and lozenges tested contain 5% nicotine
polacrilex. Nicotine polacrilex is a
nicotine-containing resin which
contains 15% nicotine. With 5%
nicotine polacrilex in the gums and
lozenges, the total nicotine in these
products is less than 1%. The Perrigo
LD50 studies reported oral and dermal
rat LD50 toxicity values of greater than
5000 mg/kg for both nicotine gum and
lozenge products. Based on their data,
Perrigo asked the Agency to exempt
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Under the final rule, the definition of
pharmaceutical includes, but is not limited to,
prescription drugs, over-the-counter drugs, dietary
supplements, and homeopathic drugs. See the
definition of pharmaceutical in §
266.500. For the
remainder of this section, EPA refers to over-the-
counter drugs, dietary supplements, and
homeopathic drugs as nonprescription
pharmaceuticals. Prescription pharmaceuticals are
defined by 21 CFR 203.3(y).
42
Under the final rule, other unsold retail items
can include any non-pharmaceutical unsold retail
item from a retail store that if discarded would
otherwise meet the definition of hazardous waste.
Examples include but are not limited to aerosol
cans, pool chemicals, mercury-containing
lightbulbs, some pesticides, certain cleaning
products, paint thinner, ammunition, and
fireworks.
43
Under the final rule, the definition of
healthcare facility includes, but is not limited to,
retail facilities such as pharmacies and retailers of
over-the-counter medications. See the definition of
healthcare facility in §
266.500.
44
Throughout this section, EPA uses the term
''retail store'' to describe facilities that send
nonprescription pharmaceutical and other unsold
retail items through reverse logistics. EPA's
understanding is that the retail sector is the only
industry that sends nonprescription
pharmaceuticals and other unsold items through
reverse logistics. However, EPA's final policy that
nonprescription pharmaceuticals and other unsold
retail items, excluding prescription
pharmaceuticals, that are sent through reverse
logistics are not solid wastes if they have a
reasonable expectation of being legitimately used/
reused or reclaimed, is not limited to the retail
sector.
45
Commenters from the retail industry commonly
use the terms ''liquidation'' or ''donation'' to refer
to legitimate methods of redistribution. For
example, see comment numbers EPA-HQ-RCRA-
2007-0932-0312 and EPA-HQ-RCRA-2007-0932-
0340 in the docket. Under RCRA's definition of
solid waste regulations in §
261.2(e), redistribution
would be referred to as use/reuse.
46
See §
261.1(b)(4) for the definition of
reclamation and §
261.1(b)(5) for the definition of
use/reuse.
47
February 14, 2014 (79 FR 8926).
from the P075 listing nicotine at
concentrations below 5%.
EPA's review of the Perrigo LD50
studies revealed several critical flaws in
the way these studies were conducted.
First, the studies were conducted using
nicotine polacrilex instead of nicotine
itself. A concentration-based listing for
nicotine would require toxicity data for
nicotine itself. The amount of nicotine
in gums and lozenges with 5% nicotine
polacrilex, as stated above, is less than
1% and it is in a form that is not readily
available when ingested or applied
(nicotine is designed to be released
slowly when it is in the form of nicotine
polacrilex). In fact, the nicotine will not
release from the nicotine-containing
resin (nicotine polacrilex) until it is
exposed to an aqueous solution or
proper pH, such as found in saliva.
Therefore, nicotine polacrilex would not
be expected to be absorbed dermally. In
contrast, nicotine is readily absorbed
dermally, as indicated by nicotine
patches. To support a concentration-
based exemption of nicotine, Perrigo
should have conducted the toxicity
studies for nicotine using the percent of
nicotine (not nicotine polacrilex) in the
gums and lozenges, since this would
have provided data on toxicity of
nicotine (the P075 listed chemical).
Second, for acute oral testing, a single
bolus dose of nicotine should have been
administered to the test animals all at
once (or over a short period of time)
instead of over a period of 24 hours.
Third, in EPA's listing regulations under
§
261.11(a)(2), the dermal LD50 toxicity
value is based on studies with rabbits,
but Perrigo's studies used rats. Fourth,
Perrigo did not provide LD50 toxicity
data for nicotine patches (this could be
because Perrigo does not manufacture
nicotine patches). Finally, no
explanation or justification was
included for using their toxicity data
which was for nicotine polacrilex with
concentrations of nicotine at less than
1%, to extrapolate to exempting all
nicotine with a concentration below
5%.
EPA, for the reasons previously
stated, has already determined that
FDA-approved OTC NRTs are not
acutely toxic and is exempting them
from the P075 listing. The toxicological
data submitted by Perrigo are for
nicotine polacrilex, instead of nicotine,
and are not considered to be adequate
to support a concentration-based
exemption for nicotine-containing
products. Therefore, the Agency has no
other information to conclude that a
particular nicotine concentration can be
exempt from the P075 listing.
VI. Reverse Distribution and Reverse
Logistics
A. Summary
Based on information collected from
outreach efforts and comments received
on the proposed rulemaking, EPA is
finalizing regulations for the reverse
distribution of prescription hazardous
waste pharmaceuticals, codifying our
existing interpretation for the reverse
logistics of nonprescription
pharmaceuticals,
41
and establishing a
policy for the reverse logistics of other
unsold retail items.
42
In the case of
prescription pharmaceuticals, EPA
maintains its position as stated in the
proposed rulemaking preamble that
prescription pharmaceuticals moving
through reverse distribution are solid
wastes at the healthcare facility (e.g.,
retail store).
43
In contrast, EPA is
codifying our existing interpretation
that nonprescription pharmaceuticals
that are sent through reverse logistics
are not solid wastes at the retail store
44
if they have a reasonable expectation of
being legitimately used/reused (e.g.,
lawfully redistributed for their intended
purpose)
45
or reclaimed.
46
Additionally, EPA is establishing a
policy that other retail items that are
sent through reverse logistics are not
solid waste at the retail store if they
have a reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for their intended purpose)
or reclaimed. The remainder of this
section proceeds as follows. First, EPA
provides a brief background on the
Agency's work to better understand the
retail sector and provide guidance on
RCRA's applicability to the retail sector.
EPA then describes the proposal to
revise the Agency's position regarding
how RCRA applies to pharmaceuticals
that are returned to reverse distributors
under the pharmaceuticals proposed
rulemaking. Finally, EPA provides the
rationale for finalizing distinct
regulations and policies for the reverse
distribution of prescription hazardous
waste pharmaceuticals and the reverse
logistics of other unsold retail items and
nonprescription pharmaceuticals and
describes new information received in
comments on the proposed rulemaking.
B. Background
In 2008, EPA initiated a review of
RCRA's applicability to the retail sector
in order to understand the challenges
the retail sector faces in complying with
RCRA. EPA's review consisted of
discussions with various members of
the retail community and states through
meetings, conferences, and site visits. In
2014, EPA published a NODA for the
Retail Sector in order to better
understand the concerns from all
stakeholders regarding RCRA's
applicability to that sector.
47
Subsequent to issuance of the NODA,
EPA continued conducting outreach
efforts (e.g., meetings, conferences, site
visits) with stakeholders to gather
information regarding the management
of unsold retail items. EPA's outreach
efforts, combined with an analysis of
comments received on the NODA,
improved the Agency's understanding
of the challenges that the retail sector
faces when managing items that have
become unsalable at stores for a variety
of reasons. Unsold retail items include
excess inventory, such as expired or
outdated items, seasonal items,
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48
EPA's Retail Strategy is available at https://
www.epa.gov/hwgenerators/strategy-addressing-
retail-sector-under-resource-conservation-and-
recovery-acts.
49
EPA has not distinguished among the terms
''supplier'' and ''vendor'' (the latter more
commonly used in the retail industry) versus
''manufacturer'' and these terms are used
interchangeably in this preamble, although the
Agency realizes that the flow of goods/products
more commonly occurs between retailers and
suppliers/vendors (or agents thereof) and that
suppliers themselves may also be manufacturers or
product formulators.
50
As discussed subsequently in this preamble,
the distinction between ''reverse distribution'' and
''reverse logistics'' has become important in light of
the Agency's response to comments received on the
proposed rule.
51
Refer to the preamble of the proposed rule
(pages 58042 and 58043), which includes
discussion of the two EPA policy memos, dated
May 13, 1981 (RCRA Online #11012) and May 16,
1991 (RCRA Online #11606).
52
Potentially creditable hazardous waste
pharmaceutical in the proposal was generally
defined as a hazardous waste pharmaceutical that
has the potential to receive manufacturer credit and
is (1) unused or un-administered; and (2) unexpired
or less than one year past expiration date. See 80
FR 58014.
53
See further discussion in the proposed rule
preamble at 80 FR 58043.
overstock, recalled items, and returned
items that cannot be returned to stock/
inventory. In the NODA, EPA used the
terms ''reverse distribution'' and
''reverse logistics'' to describe the
process or system employed by the
retail sector to manage these unsold
retail items.
Based on information gathered
through outreach and comments to the
Retail NODA, EPA developed a cohesive
plan to address the unique challenges
faced by the retail sector in complying
with RCRA regulations. This plan is
called the ''Strategy for Addressing the
Retail Sector under the Resource
Conservation and Recovery Act's
Regulatory Framework'' (Retail Strategy)
and was made publicly available on
September 12, 2016.
48
Throughout the Retail Strategy, EPA
used the term ''reverse distribution'' to
describe the system through which
unsold retail items flow and the term
''reverse logistic center'' to describe the
facilities managing the reverse flow of
these items. In crafting the Retail
Strategy, EPA recognized that the
reverse distribution process that retail
stores employ to send unsold retail
items to reverse logistics centers is a
well-established business practice in the
retail sector and retail stores sometimes
rely upon arrangements with
manufacturers
49
to determine the
ultimate disposition of these goods. EPA
also noted that a number of questions
have been raised by both retailers and
regulators regarding how the reverse
distribution process is regulated, or
should be regulated, under RCRA. In
addition, this issue becomes more
complicated for national retailers with
store locations in multiple states, as
states have taken various positions on
how RCRA regulations apply. The
Agency's understanding when crafting
the Retail Strategy was that ''reverse
distribution'' is the term most
commonly used for the return of all
pharmaceuticals (both prescription and
nonprescription) that have the potential
to receive manufacturer credit, whereas
''reverse logistics'' is the term used for
the reverse flow of retail items other
than pharmaceuticals.
50
Because of the challenges facing the
retail sector in complying with RCRA,
EPA stated in the Retail Strategy its
intent to develop a policy addressing
the reverse distribution process for the
retail sector as a whole. In the Retail
Strategy, EPA agreed to develop a
comprehensive policy that applied to all
unsold retail items, not just
pharmaceuticals. In order to fulfill
EPA's intent to address the reverse
distribution process for the retail sector
as a whole, EPA is establishing a policy
for the reverse logistics of other unsold
retail items in addition to finalizing
regulations for the reverse distribution
of prescription hazardous waste
pharmaceuticals and codifying our
existing interpretation for the reverse
logistics of nonprescription
pharmaceuticals.
C. EPA's Proposed Regulations for
Reverse Distribution of Pharmaceuticals
In the proposed Management
Standards for Hazardous Waste
Pharmaceuticals, EPA proposed to
revise the Agency's position regarding
how RCRA applies to pharmaceuticals
that are returned to reverse distributors
to obtain manufacturer credit. EPA's
original position was outlined in two
RCRA policy memos released in 1981
and 1991.
51
In the first memo, EPA
agreed that pharmaceuticals did not
become wastes until the decision to
discard was made at a manufacturing
plant. EPA's interpretation was based on
the understanding that the decision to
either return goods for reclamation or
dispose of them took place only at the
manufacturing plant. In the second
memo, EPA agreed that pharmaceuticals
returned to a manufacturer, wholesaler,
or third-party service company would
not be considered wastes until a
decision to discard has been made. In
this 1991 memo, EPA specifically noted
that, ''to the extent that the materials
involved are unused commercial
chemical products with a reasonable
expectation of being recycled in some
way when returned, the materials are
not considered waste until a
determination to discard them is made.''
Although EPA made a statement in the
preamble to the 2008 Pharmaceutical
Universal Waste proposal that linked
the value of these pharmaceuticals, in
the form of manufacturers credit, to the
idea that these pharmaceuticals would
not be considered waste, EPA never
finalized this universal waste rule or
that interpretation. Thus, the 1991
memo describes EPA's interpretation
regarding how RCRA applies to
pharmaceuticals that are returned to
reverse distributors prior to this final
rulemaking.
In the preamble to the proposed
rulemaking, EPA indicated the Agency's
intent to modify its position regarding
the point of generation in circumstances
where a pharmaceutical is sent to a
reverse distributor. EPA proposed that
the decision to send a pharmaceutical to
a reverse distributor is the point at
which a decision has been made to
discard the pharmaceutical. That is,
EPA proposed that, once the decision is
made to send a potentially creditable
hazardous waste pharmaceutical
52
from
a healthcare facility to a reverse
distributor, a decision to discard has
been made and the pharmaceutical is
considered a solid waste. This proposed
change of policy was based on the EPA's
understanding that in almost all cases,
pharmaceuticals returned to a reverse
distributor for manufacturer credit are
ultimately discarded.
53
Under the
proposed rulemaking, the definition of
''pharmaceutical reverse distributor''
included any person that receives and
accumulates potentially creditable
hazardous waste pharmaceuticals for
the purpose of facilitating or verifying
manufacturer credit. Additionally,
under the proposed rulemaking, the
definition of ''pharmaceutical'' included
not just prescription pharmaceuticals
but also nonprescription
pharmaceuticals. Therefore, under the
proposal, potentially creditable
prescription pharmaceuticals and
nonprescription pharmaceuticals
transported to a facility that facilitates
or verifies manufacturer credit, even in
cases where a credit determination is
yet to be made, would be considered
discarded and, therefore, solid wastes at
the healthcare facility.
In proposing this shift, EPA
specifically stated that, although a
pharmaceutical may retain monetary
value within the reverse distribution
system (i.e., potential exists for a
manufacturer to issue credit), the
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54
See RCRA Online #12762 for the October 8,
1986 letter from EPA to Senator John Glenn titled
''Hazardous Wastes that are Recycled, Handling.''
55
See RCRA Online #11446 for the July 20, 1989
memo from EPA to Electrum Recovery Works, Inc.
56
See docket number EPA-HQ-RCRA-2007-
0932 for the January 30, 2017 letter from EPA
Region 5 to Tradewater, LLC and the July 14, 2017
letter from EPA to A-Gas U.S. Holdings, Inc.
57
See docket number EPA-HQ-RCRA-2007-
0932 for notes from a November 19, 2013 site visit
to a lead acid battery recycler.
58
See the report prepared by the Retail Waste
Working Group, ''Surplus Household Consumer
Products and Wastes: Report to the Legislature.''
Available at: http://www.dtsc.ca.gov/
HazardousWaste/Retail_Industry/upload/SB423_
Final-Rpt.pdf.
59
See the preamble to the proposed rule for a
discussion of the comments received on the 2008
Pharmaceutical Universal Waste proposal and the
2014 Retail Notice of Data Availability that argued
that pharmaceuticals transported to reverse
distributors to receive credit are rarely, if ever,
repurposed, recycled, or reused (80 FR 58043).
pharmaceutical would still be
considered a solid waste. The ''decision
point'' on whether a pharmaceutical is
a solid waste is when it has been
discarded or when the decision has
been made to discard the material. That
is, when a pharmaceutical is discarded
determines whether it is a solid waste,
not whether the pharmaceutical has
value. This interpretation is consistent
with EPA's approach under RCRA that
materials that are discarded are solid
wastes, regardless of their monetary
value or the economics of the system in
which those discarded materials are
handled. EPA has long maintained, and
continues to maintain, the interpretation
that value is not determinative of solid
waste status.
In 1986, EPA released a memo on the
regulation of hazardous wastes that are
recycled, and wrote that ''persons
transporting and storing hazardous
wastes before recycling are similar to
persons transporting and storing
hazardous waste before disposal: There
is nothing about the waste that makes it
so valuable that safe handling is assured
absent regulation.''
54
EPA reaffirmed
this interpretation in a 1989 memo on
the regulatory status of solder
skimmings (tin/lead alloy) purchased
for reclamation, writing that even
though the skimmings have value, they
are still considered a solid waste.
55
In a more recent application of this
interpretation, EPA outlined its position
on chlorofluorocarbons (CFCs) that are
processed back into the refrigerant
market or sent for destruction, but
receive carbon offset credits and thus
have value, in two memos signed in
2017.
56
Irrespective of whether facilities
pay for hazardous CFCs or receive
carbon offsets for the destruction of
CFCs, the material is considered a solid
waste. As another example of a material
that is discarded as solid waste but has
monetary value, EPA maintains that
spent lead acid batteries being
reclaimed are regulated as hazardous
waste under part 266 subpart G or under
universal waste irrespective of the fact
that the batteries may have value and
that reclamation facilities sometimes
buy batteries due to the monetary value
of the lead.
57
This finding was upheld
in United States v. Ilco Inc., 996 F. 2d
1126, where the court found that the
fact that the batteries were discarded
''does not change just because a
reclaimer has purchased or finds value
in the components.'' EPA also maintains
that recyclable materials that are
reclaimed to recover economically
significant amounts of gold, silver, and
other various precious metals are still
regulated as hazardous waste under part
266 subpart F despite the fact that the
precious metals have monetary value.
Additionally, the holdings of multiple
court decisions is that simply because a
hazardous waste has, or may have,
monetary value does not mean the
material loses its status as a solid waste.
See American Petroleum Institute v.
EPA, 906 F.2d 741 n.16 (D.C. Cir. 1990);
United States v. ILCO Inc., 996 F.2d
1126 1131-32 (11th Cir. 1993); Owen
Steel v. Browner, 37 F.3d 146, 150 (4th
Cir. 1994).
D. EPA's Final Reverse Distribution
Regulation and Reverse Logistics Policy
1. Introduction
In light of comments received on the
proposed rulemaking, along with EPA's
understanding of current business
practices, the Agency is making a clear
distinction in the final rule between the
reverse distribution of prescription
pharmaceuticals and the reverse
logistics of other unsold retail items,
including nonprescription
pharmaceuticals. In addition to
receiving information from comments
on the proposed rulemaking, EPA
gathered information from site visits
and by participating as an observer in
the Retail Waste Working Group.
58
In
the case of prescription
pharmaceuticals, EPA is finalizing, as
proposed, that prescription
pharmaceuticals moving through
reverse distribution are solid wastes at
the healthcare facility. However, EPA
notes that these tailored RCRA
regulations for prescription
pharmaceuticals going through reverse
distribution are designed with existing
business practices in mind. For more
explanation, see section 4 below and
section XVII of this preamble. EPA is
also codifying our existing
interpretation for the reverse logistics of
nonprescription pharmaceuticals. EPA
makes it clear in §
266.501(g)(2) that
nonprescription pharmaceuticals are not
solid wastes because they have a
reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for their intended purpose)
or reclaimed (also see section IX of this
preamble). Also in this preamble, EPA
is establishing a policy that other unsold
retail items that are sent through reverse
logistics are not solid wastes at the retail
store because they have a reasonable
expectation of being legitimately used/
reused (e.g., lawfully redistributed for
its intended purpose) or reclaimed.
2. Comments on EPA's Proposed
Reverse Distribution Regulation
EPA received numerous comments on
the proposed position that the decision
to send potentially creditable
pharmaceuticals through reverse
distribution is a decision to discard.
States were generally supportive of the
proposed change in position, while
many comments from the retail industry
objected to the Agency's proposed
change in position.
EPA received many broad comments
on EPAs proposed position regarding
the waste status of pharmaceuticals
going through reverse distribution and
reverse logistics, which are discussed in
further detail in section XVII. EPA also
received many comments describing the
potential burden that the revised
interpretation would place on the retail
industry, which are also discussed in
further detail in section XVII. The
remainder of this section focuses on
comments received on the distinction
between the reverse distribution of
prescription pharmaceuticals and the
reverse logistics of nonprescription
pharmaceuticals and other unsold retail
items.
EPA received numerous comments
that described the key distinctions
between reverse distribution and reverse
logistics as they pertain to the waste
status of pharmaceuticals and other
unsold retail items going through these
two processes. Multiple commenters
argued that EPA mistakenly concluded
that pharmaceuticals, including
nonprescription pharmaceuticals,
transported to facilities that facilitate or
verify manufacturer credit are in most,
if not all cases, discarded.
59
Commenters argued that the Agency
failed to take into account the ability to
donate, liquidate, or reclaim
nonprescription pharmaceuticals that
are sent through reverse logistics.
However, commenters did confirm that
prescription pharmaceuticals are in
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60
For example, see comment number EPA-HQ-
RCRA-2007-0932-0377.
61
See comment number EPA-HQ-RCRA-2007-
0932-0295 in the docket.
62
See comment number EPA-HQ-RCRA-2007-
0932-0312 in the docket.
63
Ibid.
64
See comment number EPA-HQ-RCRA-2007-
0932-0340 in the docket.
65
EPA uses the term ''unsold retail items'' to refer
to excess inventory, such as expired or outdated
items, seasonal items, overstock, recalled products,
and returned items that cannot be returned to stock/
inventory. Walmart and other commenters from the
retail industry use the term ''consumer goods'' to
refer to similar items.
66
EPA has not distinguished among the terms
''supplier'' and ''vendor'' verses ''manufacturer''
and the terms are used interchangeably throughout
the preamble. The Agency more frequently used the
term ''manufacturer'' while retail industry
commenters more frequently used the term
''vendor.''
67
EPA did not receive data on the ultimate
disposition of consumer products returned to the
vendor. EPA further discusses our policy on unsold
retail items that are returned to the vendor in
section ''e.) Nonprescription Pharmaceuticals and
Other Retail Items Going through Reverse Logistics
Are Not Wastes.''
68
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket.
69
See comment number EPA-HQ-RCRA-2007-
0932-0295 in the docket.
70
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket.
most, if not all cases, discarded.
Commenters argued that this fact
contradicts EPA's rationale in proposing
that all pharmaceuticals, including
nonprescription pharmaceuticals, going
through reverse distribution and reverse
logistics are wastes at the healthcare
facility.
Overall, commenters encouraged EPA
to adopt the terminology used by
industry where ''reverse distribution''
only refers to the process by which
prescription pharmaceuticals are sent to
a reverse distributor for the evaluation
of manufacturers credit and ''reverse
logistics'' refers to the process by which
nonprescription pharmaceuticals and
other unsold retail items are sent to a
reverse logistics center and evaluated
for legitimate use/reuse or reclamation.
Commenters requested that if EPA
intends to finalize that a decision to
send a pharmaceutical to a reverse
distributor is the point at which a
decision has been made to discard the
pharmaceutical, that EPA also adopt
separate and distinct policies regarding
how RCRA applies to prescription
pharmaceuticals going through ''reverse
distribution'' and to nonprescription
pharmaceuticals and other unsold retail
items going through ''reverse
logistics.''
60
One commenter noted that
reverse logistics is an integral
component of inventory management,
product recall confirmation, sale
through liquidation, donation for use,
and reclamation of commercial
products-contributing billions of
dollars to the retail industry annually.
61
Moreover, this commenter noted that
the reverse logistics operations help
maximize the amount of OTC
pharmaceuticals and dietary
supplements that can be reused or
reclaimed. Another commenter made a
similar argument, writing that the
purpose of reverse distribution of
prescription pharmaceuticals is to
determinate creditworthiness while the
primary purpose of reverse logistics of
nonprescription pharmaceuticals is to
aggregate and redirect viable products
into another supply chain.
62
One commenter honed in on the
argument that EPA failed to take into
account the ability to legitimately use/
reuse or reclaim nonprescription
pharmaceuticals that are sent through
reverse logistics.
63
This commenter
pointed out that stringent chain-of-
custody documentation and disposal
requirements under DEA regulations
and state Board of Pharmacy
Requirements only apply to prescription
pharmaceuticals. In contrast, most
nonprescription pharmaceuticals are not
susceptible to the same diversion risks
as prescription pharmaceuticals and do
not face the same documentation and
disposal requirements. This makes it
possible to use/reuse or reclaim
nonprescription pharmaceuticals.
Walmart Stores Inc. commented that
pharmaceuticals going through reverse
distribution that are ultimately
discarded are likely prescription
pharmaceuticals.
64
Walmart wrote that
only a small percentage of the consumer
goods
65
managed at Walmart's six
Return Centers, which will be
considered reverse logistics centers
under EPA's final policy, are discarded.
According to Walmart's data, only 2%
of the consumer goods managed at
Walmart's Return Centers are discarded
by Walmart, while 28% are donated,
recycled, or liquidated and 70% are
returned to the vendor.
66
Further, for
the consumer products that are
considered RCRA hazardous waste
when discarded, only 1% are discarded,
33% are liquidated or donated, and 66%
are returned to the vendor.
67
Inmar, Inc.
also argued that only a small percentage
of the OTC pharmaceuticals returned to
a reverse logistics center are disposed
rather than liquidated, donated, or
returned to the vendor.
68
Inmar does not
maintain specific data on this issue, but
wrote that it would not be unusual for
one of their subsidiary reverse logistics
centers handling nonprescription
pharmaceuticals and other consumer
goods to send as little as 5% of the
products for destruction.
Retail Industry Leaders Association
(RILA) et al. pointed out that
nonprescription pharmaceuticals do not
face the same restrictions that preclude
the redistribution or donation of
prescription pharmaceuticals.
69
RILA et
al. added that nonprescription
pharmaceuticals are regularly donated
and liquidated and cited data from two
retailers.
Inmar Inc. also noted that when an
item is returned because an expiration
date has been exceeded, disposal is
more often the required disposition, but
the products may be returned to the
manufacturer for further evaluation for
potential liquidation.
70
Inmar also wrote
that nonprescription pharmaceuticals
with ''best by'' dates (as opposed to
expiration dates) can still be donated or
liquidated after the date has passed.
Overall, these comments help to
underscore the differences between how
prescription pharmaceuticals and other
unsold retail items, including
nonprescription pharmaceuticals, are
managed within the reverse supply
chain. These comments led EPA to
make a clear distinction in the final rule
between the reverse distribution of
prescription pharmaceuticals and the
reverse logistics of all other unsold
retail items, including nonprescription
pharmaceuticals.
3. Distinction Between Reverse
Distribution and Reverse Logistics
EPA acknowledges that reverse
distribution and reverse logistics
processes share common elements in
terms of the role each plays in the
management of pharmaceuticals.
However, based on the comments
received on the proposal, especially
those summarized above, the Agency
recognizes that there is a key distinction
between how prescription
pharmaceuticals and nonprescription
pharmaceuticals (see definition of
pharmaceutical in §
266.500) are
managed in the reverse supply chain.
The key distinction is that there is not
a reasonable expectation of legitimate
use/reuse (e.g., lawful redistribution for
its intended purpose) or reclamation for
prescription pharmaceuticals, except in
very limited circumstances, but there is
for other retail items, including
nonprescription pharmaceuticals.
Prescription pharmaceuticals shipped
from healthcare facilities to reverse
distributors for the evaluation of
manufacturer credit are almost always
discarded. EPA is aware that
prescription pharmaceuticals are
sometimes lawfully donated, in which
case the pharmaceuticals would not be
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EPA is aware of one non-profit organization
that facilitates donations of prescription
pharmaceuticals. See comment from SIRUM in the
docket (EPA-HQ-RCRA-2007-0932-0353). EPA is
also aware of multiple states, including Iowa,
Wyoming, and Oklahoma, that run prescription
pharmaceutical return and reuse programs. For
more information, see ''State Prescription Drug
Return, Reuse and Recycling Laws'' at http://
www.ncsl.org/research/health/state-prescription-
drug-return-reuse-and-recycling.aspx.
72
The example cited was an unconfirmed claim
that a rodent poison manufacturer could use
discarded pharmaceutical warfarin tablets as
feedstock in its process. See comment number
EPA-HQ-RCRA-2007-0932-0358 in the docket.
73
See docket number EPA-HQ-RCRA-2007-
0932 for reverse distributor responses to EPA's
questions about reverse distribution of
pharmaceuticals, notes from Agency meetings with
retail industry representatives, and notes from site
visits to reverse distribution facilities.
74
See comment number EPA-HQ-RCRA-2007-
0932-0340 in the docket.
a solid waste.
71
In the case of
nonprescription pharmaceuticals and
other unsold retail items that are sent to
a reverse logistics center, there is often
a reasonable expectation that they will
be legitimately used/reused (e.g.,
lawfully redistributed for their intended
purpose) or reclaimed.
EPA recognizes that the awarding of
credit for unsold pharmaceuticals is a
critical element of both the reverse
distribution and reverse logistics
processes as it provides a healthcare
facility financial incentive to not only
stock a particular pharmaceutical but
also to defray costs associated with
transporting a pharmaceutical to a
reverse distributor or reverse logistics
center. However, it is EPA's position
that the inherent monetary ''value''
conferred on any pharmaceutical due to
the potential to receive manufacturer
credit is not a proper indicator of waste
status. Rather, the decision to discard is
determinative of when an unsold
product becomes a solid waste. Under
EPA's final rule and preamble, if a
nonprescription pharmaceutical or other
retail item becomes unsalable at a retail
store it can continue to be considered a
product until a reverse logistics center
or other subsequent entity makes the
decision to discard it, as long as there
is a reasonable expectation of it being
legitimately used/reused (e.g., lawfully
redistributed for its intended purpose)
or reclaimed.
4. Prescription Pharmaceuticals Going
Through Reverse Distribution Are
Wastes at the Healthcare Facility
In the case of prescription
pharmaceuticals, EPA maintains its
position, as stated in the proposed
rulemaking preamble and reflected in
the regulatory text, that prescription
pharmaceuticals moving through
reverse distribution are solid wastes
starting at the healthcare facility. This
includes prescription pharmaceuticals
that, as potentially creditable hazardous
waste pharmaceuticals, are sent from a
retail facility or healthcare facility to a
reverse distributor for manufacturer
credit evaluation (see definition of
potentially creditable hazardous waste
pharmaceutical in §
266.500). Although
the potential exists for a manufacturer to
issue credit for a prescription
pharmaceutical, the ''decision point'' on
when a pharmaceutical is a solid waste
is when the decision has been made to
discard the item. That is, a
pharmaceutical is a solid waste when
the decision has been made to discard
regardless of whether the
pharmaceutical has value. Although
prescription pharmaceuticals are
evaluated for, and in many cases
ultimately receive, manufacturer credit,
it remains apparent to EPA that these
pharmaceuticals will seldom, if ever, be
legitimately used/reused (e.g., lawfully
redistributed for their intended purpose)
or reclaimed after they are sent to a
reverse distributor. Thus, a decision to
send prescription pharmaceuticals to a
reverse distributor is a decision to
discard the material. None of the
comments on the proposed rule alter
EPA's position regarding the likelihood
of redistribution or reclamation of
prescription pharmaceuticals being
managed through reverse distribution.
Rather, EPA received many comments
that agreed with EPA's proposed
interpretation that the decision to send
a pharmaceutical to a reverse distributor
is a decision to discard as it pertains to
prescription pharmaceuticals because
there are limited opportunities to
legitimately use/reuse or reclaim
prescription pharmaceuticals. In
circumstances when prescription
pharmaceuticals are lawfully donated
for their intended purpose, they would
not be considered a solid waste and we
have specifically noted this in the
regulations (see §
266.501(g)(1) and the
definition of hazardous waste
pharmaceutical in §
266.500).
Many of the broad comments in
support of the proposed reinterpretation
provided examples but did not
distinguish between prescription
pharmaceuticals and nonprescription
pharmaceuticals. For example, multiple
commenters argued that
pharmaceuticals transported to a reverse
distributor are rarely redistributed or
reclaimed, and are usually destroyed,
but did not explain if this applied only
to prescription pharmaceuticals. One
commenter observed that many
manufacturers contract with reverse
distributors to dispose of unsold
pharmaceuticals after review for credit
eligibility is complete, suggesting that
use/reuse or reclamation does not
generally occur. This commenter was
only aware of one instance of potential
reuse of a pharmaceutical after being
sent through reverse distribution.
72
That
being said, based on what EPA has
learned from retail industry
commenters, site visits, and discussions
with retailers about prescription
pharmaceuticals verses nonprescription
pharmaceuticals, EPA can infer that
these comments likely refer to the
reverse distribution of prescription
pharmaceuticals.
73
EPA's inference is
supported by other comments received
on the proposal. For example, Walmart
argued that the comments EPA received
on the 2008 Pharmaceutical Universal
Waste proposal (where pharmaceuticals
were defined only as prescription
pharmaceuticals) and the 2014 Retail
Notice of Data Availability that
pharmaceuticals going through reverse
distribution are ultimately discarded
were likely talking about prescription
pharmaceuticals.
74
In conclusion, a material is
considered a solid waste if it is
accumulated or stored before or in lieu
of being disposed of, burned, or
incinerated (§
261.2(b)(3)). Even if the
healthcare facility intends to receive
credit for the prescription
pharmaceutical and the reverse
distributor intends to evaluate the
prescription pharmaceutical for credit,
the pharmaceutical is still considered a
discarded material (§
261.2(a)(2)(i))
because it is being accumulated and
stored prior to being sent for treatment
(rather than being accumulated or stored
prior to being used/reused or
reclaimed). Although the healthcare
facility or reverse distributor intends to
elicit credit from the prescription
pharmaceutical in the interim period
before it is sent for treatment, the
pharmaceutical is still considered a
discarded material. An intent to receive
credit does not preclude the
pharmaceuticals from being discarded;
they are not mutually exclusive.
Although EPA maintains its position
that prescription pharmaceuticals
moving through reverse distribution are
solid wastes at the healthcare facility,
this final rule establishes streamlined,
practical standards for managing
potentially creditable hazardous waste
pharmaceuticals that will reduce
regulatory burden on retailers and align
with the existing practices of the retail
sector. Thus, EPA's position that
prescription pharmaceuticals moving
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See memo dated May 16, 1991, From Lowrance
to Schulz, RCRA Online #11606.
76
See 81 FR 18527; March 31, 2016.
through reverse distribution are solid
wastes at the healthcare facility only
subjects these hazardous waste
pharmaceuticals to the streamlined part
266 subpart P standards versus the full
RCRA Subtitle C regulations. For
example, EPA does not require
healthcare facilities to use a hazardous
waste manifest or a hazardous waste
transporter when shipping potentially
creditable hazardous waste
pharmaceutical to a reverse distributor.
See section XVI.D for a discussion of the
shipping standards for potentially
creditable hazardous waste
pharmaceuticals.
Because the point of generation of
potentially creditable hazardous waste
pharmaceuticals is at the healthcare
facility, EPA can impose the RCRA
Subtitle C cradle-to-grave management
of hazardous wastes. Specifically, it
allows us to impose consistent and
enforceable tracking of hazardous waste
pharmaceuticals from healthcare
facilities en route to reverse distributors.
Lack of tracking was identified as a
regulatory gap by many commenters on
our 2008 proposal to add
pharmaceuticals to the Universal Waste
program. The tracking provides the
benefit of reducing the risk of diversion
of these unused hazardous waste
pharmaceuticals onto the black market,
thus fulfilling our statutory mandate of
protecting human health.
5. Nonprescription Pharmaceuticals and
Other Retail Items Going Through
Reverse Logistics Are Not Wastes if
They Have a Reasonable Expectation of
Being Legitimately Used/Reused or
Reclaimed
Although EPA includes
nonprescription pharmaceuticals in the
definition of ''pharmaceutical'' under
the final rule, the Agency makes it clear
in the definition of ''hazardous waste
pharmaceutical'' that nonprescription
pharmaceuticals are not solid wastes,
and therefore not hazardous waste
pharmaceuticals, if they have a
reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for its intended purpose)
or reclaimed. The applicability of the
final rule also has a new provision in
§
266.501(g)(2) making it clear that a
nonprescription pharmaceutical that is
not a solid waste because it has a
reasonable expectation of being
legitimately used/reused or reclaimed is
not subject to parts 260-273.
Additionally, the final definition of
reverse distributor has been revised so
that it applies only to the reverse
distribution of prescription
pharmaceuticals.
In the final rule, EPA is reaffirming
the Agency's previous policies on
redistribution expressed in memos in
1981 and 1991 with respect to
nonprescription pharmaceuticals and
other retail items that have become
unsalable at the retail store and are
being managed by a reverse logistics
center through the reverse logistics
process. That is, EPA is maintaining a
policy that nonprescription
pharmaceuticals and other retail items
that are sent through reverse logistics
are not solid wastes at the retail store if
they have a reasonable expectation of
being legitimately used/reused (e.g.,
lawfully redistributed for its intended
purpose) or reclaimed. EPA recognizes
that reverse logistics centers are
designed to evaluate unsold retail items,
analyze secondary markets, and assess
the suitability of the unsold retail items
for reuse in those secondary markets.
These services promote the donation,
liquidation, and reuse of unsold retail
items and reduce overall waste.
Importantly, these activities are distinct
from the activities of reverse distributors
of prescription pharmaceuticals.
Reverse distributors of prescription
pharmaceuticals are not designed to
evaluate unsold prescription
pharmaceuticals and assess the
suitability of the prescription
pharmaceuticals for reuse in secondary
markets. As mentioned previously,
commenters pointed out that the
purpose of reverse distribution of
prescription pharmaceuticals is to
determinate creditworthiness while the
primary purpose of reverse logistics of
nonprescription pharmaceuticals is to
aggregate and redirect viable products
into another supply chain.
Although EPA is reaffirming this
policy, EPA remains concerned about
the potential for overuse of reverse
logistics centers, a concern we originally
raised in a 1991 memo related to reverse
distribution: ''a reverse distribution
system cannot be used as a waste
management service to customers/
generators without the applicable
regulatory controls on waste
management being in place .
.
. to the
extent that the materials involved are
unused commercial chemical products
with a reasonable expectation of being
recycled in some way when returned,
the materials are not considered as
wastes until a determination has been
made to discard them.''
75
To reiterate,
in order to avoid being considered solid
waste, items, including nonprescription
pharmaceuticals, sent through reverse
logistics, must have some reasonable
expectation of being legitimately used/
reused or reclaimed. The 199l guidance
allowing pharmaceuticals to go through
reverse distribution without being
considered solid waste was based on the
notion that they had the potential for
recycling by use/reuse. Over the years,
however, many have come to disregard
the intent behind this guidance and
erroneously believed that it was a
blanket statement that pharmaceuticals
going through reverse distribution were
not solid wastes, even if they did not
have a reasonable expectation of being
redistributed or recycled. We strongly
encourage the use of reverse logistics
centers to facilitate redistribution and
legitimate recycling to the fullest extent
possible, and thus, reduce the amount of
waste being generated. But we also
caution reverse logistic centers not to
become de facto waste management
facilities for their customers. If this were
to occur, it could be the case that the
decision to discard for nonprescription
pharmaceuticals and other retail items
would have occurred at the retail store
or healthcare facility.
Of course, once a reverse logistics
center makes a decision to discard an
item, it becomes a solid waste and, if it
is listed or exhibits a characteristic, a
hazardous waste. The reverse logistics
center is subject to the applicable RCRA
regulations, such as part 262, for the
generation and accumulation of
hazardous waste, including hazardous
waste pharmaceuticals, but not part 266
subpart P.
EPA notes that although
nonprescription pharmaceuticals and
other retail items that are sent through
reverse logistics are not solid wastes at
the retail store if they have a reasonable
expectation of being legitimately used/
reused or reclaimed, the items must be
shipped in accordance will all
applicable Department of
Transportation (DOT) regulations. For
example, DOT promulgated a final rule
in March 2016 on the reverse logistics
of hazardous materials. This rule
includes provisions to help ensure that
items, including consumer grade
fireworks, are in original packaging
when shipped from a retail store to a
manufacturer, supplier, or distribution
facility.
76
There are six issues that came to
EPA's attention when shaping this final
reverse logistics policy. The first issue
regards the ultimate disposition of
unsold retail items moving through
reverse logistics. The second issue
regards unsold retail items that have
expired. The third issue involves
instances when retail items cannot be
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77
See comment number EPA-HQ-RCRA-2007-
0932-0340 in the docket.
78
EPA uses the term ''expired'' consistent with
Food and Drug Administration regulations. See 21
CFR part 201.66, part 201.17, and 211.137.
79
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket.
80
See U.S. Food and Drug Administration
''Question and Answers for the Public: Donating
Drugs to International Humanitarian Relief Efforts''
available at: https://www.fda.gov/downloads/
NewsEvents/PublicHealthFocus/UCM249617.pdf.
81
This definition is derived from the definition
of ''business rules'' in the ''Surplus Household
Consumer Products and Wastes: Report to the
Legislature.'' Available at: http://www.dtsc.ca.gov/
HazardousWaste/Retail_Industry/upload/SB423_
Final-Rpt.pdf.
82
See discussion of ''destroy dispositions'' in the
''Surplus Household Consumer Products and
Wastes: Report to the Legislature.'' Available at:
http://www.dtsc.ca.gov/HazardousWaste/Retail_
Industry/upload/SB423_Final-Rpt.pdf.
83
Additional information on the Adjustable Rate
Policy and other reimbursement policies for
unsalable items can be found in the publication
entitled, 2008 Joint Industry Unsaleables
Management Study: The Real Causes and
Actionable Solutions. This publication is available
at http://www.gmaonline.org/downloads/research-
and-reports/UnsaleablesFINAL091108.pdf.
legitimately used/reused (e.g., lawfully
redistributed for their intended purpose)
because the items are subject to a
''destroy disposition.'' The fourth issue
regards the crediting process for unsold
retail items. The fifth issue involves
instances when nonprescription
pharmaceuticals and other unsold retail
items become subject to a voluntary,
federally mandated, or state mandated
recall. The final issue involves instances
when nonprescription pharmaceuticals
and other unsold retail items cannot be
sent through reverse logistics because
they are broken, damaged, or leaking.
a. Unsold retail items returned to the
manufacturer or vendor. The first issue
regards the ultimate disposition of
unsold retail items moving through
reverse logistics. As noted previously,
data from commenters suggests a
majority of unsold retail items moving
through reverse logistics are returned to
the manufacturer or vendor.
77
EPA did
not receive data on the ultimate
disposition of retail items that are
returned to a manufacturer or vendor
from a reverse logistics center. For this
final action, EPA assumes the items are
not wastes if they have a reasonable
expectation of being legitimately used/
reused (e.g., lawfully redistributed for
its intended purpose) or reclaimed.
However, if nonprescription
pharmaceuticals or other retail items do
not have a reasonable expectation of
being legitimately used/reused (e.g.,
lawfully redistributed for their intended
purpose) or reclaimed after they are
returned to a manufacturer or vendor,
then the nonprescription
pharmaceutical or other unsold retail
item would be a solid and potentially
hazardous waste at the reverse logistics
center.
b. Unsold retail items that have
expired. The second issue regards
unsold retail items that have expired.
78
As mentioned previously, commenters
noted that when an item is sent to a
reverse logistics center because an
expiration date has been exceeded,
disposal is most often the required
disposition, however the items may be
returned to the manufacturer for further
evaluation for potential liquidation.
79
Furthermore, nonprescription
pharmaceuticals with ''best by'' dates
(as opposed to expiration dates) often
can still be donated or liquidated after
the date has passed. In addition to
information received from commenters
suggesting that expired products might
be considered eligible for redistribution,
FDA occasionally allows the donation of
drugs that are past the expiration date
shown on the label when provided
sufficient information to show the
expired pharmaceuticals are safe and
effective and other specific criteria have
been met.
80
Thus, for this final action,
EPA assumes that nonprescription
pharmaceuticals and other unsold retail
items that have expired are not wastes
if they have a reasonable expectation of
being legitimately used/reused (e.g.,
lawfully redistributed for its intended
purpose) or reclaimed. These items are
in their original, intact packaging and
do not pose a high risk of release to the
environment. Further, this position is
consistent with the goal of the RCRA
statute to reduce waste, as EPA is
concerned that considering unsold retail
items that have expired to be wastes at
the retail store could introduce an
unintended incentive for retailers to
remove those items from shelves in
advance of expiration dates, resulting in
an unnecessary increase in overall waste
generation.
c. Unsold retail items subject to a
destroy disposition. The third issue
involves instances when retail items
cannot be legitimately used/reused (e.g.,
lawfully redistributed for their intended
purpose) because the items are subject
to a ''destroy disposition.'' A destroy
disposition is when a manufacturer has
established ''business rules'' that
prohibit unsold retail items from being
redistributed for their intended purpose
(i.e., liquidated or donated). The term
''business rules'' (i.e., manufacturer
return policies) refers to the rules that
govern the disposition of retail items
agreed to by the manufacturer, retailer,
and reverse distributor or reverse
logistics center.
81
The Agency's
understanding is that manufacturers
adopt destroy dispositions over
concerns related to liability and brand
protection and that assigning a destroy
disposition is not a common practice
because it precludes income from
potential redistribution and results in
disposal costs.
82
For this final action, if
a manufacturer has established business
rules that prohibit unsold retail items
from being legitimately used/reused
(e.g., lawfully redistributed for their
intended purpose) because the items are
subject to a ''destroy disposition,'' and
that prohibit the unsold retail items
from being reclaimed, the items are
considered solid waste at the retail store
or healthcare facility. However, if a
manufacturer has established business
rules that do not imply that disposal is
the ultimate disposition for unsold retail
items, and there is a reasonable
expectation the items will be reclaimed,
these items would not be solid wastes
at the retail store when they are sent
through reverse logistics. Thus, a
manufacturer can adopt business rules
that prohibit the lawful redistribution of
retail items for their intended purpose
(i.e., liquidation or donation), but allow
for the items to be sent through reverse
logistics for reclamation. These items
would not be wastes at the retail store
if there is a reasonable expectation the
items will be reclaimed.
d. Crediting process for unsold retail
items. The fourth issue regards the
crediting process for unsold retail items.
It is the Agency's understanding that
there are two primary credit models.
The first is the ''traditional approach''
whereby credit is awarded after unsold
retail items are returned to a reverse
logistics center for processing. The
second is the adjustable rate policy,
which is also commonly referred to as
a ''swell allowance,'' whereby credit is
awarded up-front based on an
assumption that a certain percentage of
items will become unsalable for various
reasons at the primary retailer.
83
EPA's
understanding is that one of the goals of
the adjustable rate policy is to reduce
the amount of unsold items sent through
to reverse logistics centers and to
encourage sale at the primary retailer-
even if this means discounting those
items. EPA's understanding is that
under such an approach, retailers are
responsible for managing unsold retail
items and determining the ultimate
disposition since the manufacturer is
not involved in the disposition decision.
That being said, retailers can utilize
reverse logistics to assist in the
management and disposition of unsold
retail items sold under an adjustable
rate policy. More importantly, under
EPA's final policy, although the
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84
See 15 U.S.C. 1471-1477 for the Poison
Prevention Packaging Act.
85
Public Law 114-116 (January 28, 2016).
86
The CPSC has jurisdiction over more than
15,000 kinds of consumer products used in and
around the home, in sports, recreation and schools.
See https://www.recalls.gov/cpsc.html for more
information.
87
See 21 CFR 7.46(a)(8) and 21 CFR 7.45(b),
respectively.
88
See RCRA Online #14893 for the June 23, 2017
memo titled ''Recalled Takata Airbag Inflators.''
89
Walmart Consent Agreement and Final Order,
Docket Nos. RCRA-HQ-2013-4001 and FIFRA-
HQ-2013-5056.
90
See comment number EPA-HQ-RCRA-2007-
0932-0312 in the docket.
potential exists for a manufacturer to
issue credit for an unsold retail item, the
''decision point'' on whether a retail
item is a solid waste is when the
decision has been made to discard the
material. In other words, a
pharmaceutical is a solid waste when
the decision has been made to discard
regardless of whether the
pharmaceutical has value. Thus, for this
final action, the credit model is not
relevant to the waste status of unsold
retail items. EPA assumes that
nonprescription pharmaceuticals and
other unsold retail items that receive
credit up-front through an adjustable
rate policy are not wastes if they have
a reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for their intended purpose)
or reclaimed.
e. Unsold retail items subject to a
recall. The fifth issue involves instances
when nonprescription pharmaceuticals
and other unsold retail items become
subject to a voluntary, federally
mandated, or state mandated recall.
Almost all pharmaceutical recalls are
overseen by FDA. However, under the
Poison Prevention Packaging Act, the
U.S. Consumer Product Safety
Commission (CPSC) has authority
regarding special packaging (sometimes
called child resistant packaging) of
certain household products, including
drugs (as that term is defined in the
Federal Food, Drug, and Cosmetic
Act).
84
Similarly, under the child
Nicotine Poisoning Prevention Act of
2015, CPSC has authority for
administering special packaging
requirements for liquid nicotine
containers.
85
Thus, CPSC oversees a
recall if there is a problem with a
pharmaceutical's special packaging or
containers for liquid nicotine.
Additionally, CPSC has jurisdiction
over recalls of many other consumer
products sold at retail stores.
86
EPA is
choosing not to apply RCRA regulations
to nonprescription pharmaceuticals and
other unsold retail items while they are
subject to a recall, provided the recall is
regulated and overseen by FDA or
CPSC. This is true whether they become
subject to a recall at a reverse logistics
center, healthcare facility, or retail store.
It is possible that recalled
nonprescription pharmaceuticals and
other unsold retail items are not a solid
waste if they are legitimately used/
reused or reclaimed. For example, if
CPSC oversees a recall if there is a
problem with a pharmaceutical's
packaging (e.g., an item's packaging
poses a threat because it is not
sufficiently child resistant), it is
possible the pharmaceutical could still
be sent for reclamation. Although it is
difficult for EPA to make a blanket
determination on whether all recalled
nonprescription pharmaceuticals and
other unsold retail items are or are not
solid wastes, EPA is choosing not to
apply RCRA regulations to recalled
nonprescription pharmaceuticals and
other unsold retail items provided the
recall is overseen by FDA or CPSC.
When FDA directs the destruction of
some or all of the recalled retail items,
or CPSC grants permission to dispose or
destroy some or all of the recalled items,
the materials that are hazardous waste
must be managed in accordance with
RCRA, including the hazardous waste
generator regulations standards in 40
CFR part 262.
Although FDA and CPSC are the
federal agencies that primarily regulate
recalled nonprescription
pharmaceuticals and other unsold retail
items, other federal agencies regulate
some recalled retail items. For example,
the National Highway Traffic Safety
Administration oversees motor vehicle
defects and safety recalls. Although
other federal agencies may occasionally
regulate recalled retail items, EPA is
only choosing not to apply RCRA
regulations to recalled nonprescription
pharmaceuticals and other unsold retail
items when the recall is overseen by
FDA or CPSC. CPSC requires
manufacturers to develop a recall
strategy that outlines all of the actions
to be taken on behalf of the
manufacturer from start to finish. FDA
requires firms that initiate a recall to
develop a recall strategy and
recommends that firms that initiate a
FDA-requested recall develop a recall
strategy.
87
Included as a required
component of a comprehensive recall
strategy is a requirement that FDA or
CPSC approves a manufacturer's
decision to take the action to discard
some or all of the recalled items. Thus,
EPA believes it is reasonable not to
apply RCRA regulations to recalled
nonprescription pharmaceuticals and
other unsold retail items when the recall
is overseen by FDA or CPSC. However,
the Agency will continue to evaluate
recalled nonprescription
pharmaceuticals and other unsold retail
items managed by other federal agencies
on a case-by-case basis. As an example,
see the memo that EPA released in 2017
that describes how RCRA regulations
apply to recalled Takata airbag inflators
while they are being held under the
2015 DOT preservation order.
88
EPA's
policy does not apply to unused
pesticides that are suspended or
canceled under the Federal Insecticide,
Fungicide, and Rodenticide Act and
recalled, as these can be managed as
universal waste under 40 CFR part 273.
Finally, while EPA is not applying
RCRA regulations in these situations,
we note that if recalled nonprescription
pharmaceuticals and other unsold retail
items are not managed and stored in a
manner that prevents release to the
environment, they may be considered a
solid waste and a hazardous waste
under sections 3007, 3013, and 7003 of
RCRA.
f. Unsold retail items that are broken,
damaged, or leaking. The sixth issue
involves instances when
nonprescription pharmaceuticals and
other unsold retail items cannot be sent
through reverse logistics because they
are broken, damaged, or leaking. In
recent years, EPA took multiple
enforcement actions against national
retailers for sending hazardous waste, in
the form of broken and/or leaking items
with hazardous contents, to
unpermitted TSDFs (in the form of
reverse distributors and reverse logistics
centers), among other RCRA
violations.
89
The resulting settlements
specify that unsold retail items with
broken and/or leaking packaging are
waste at the retailer and, if they are
hazardous, cannot be sent to a reverse
distributor or reverse logistics center.
CVS commented on the proposed
rulemaking and asked that EPA clarify
that when pharmaceutical packaging is
in sufficiently poor condition that it is
broken, leaking, or otherwise unable to
be used for its intended purpose, that
those pharmaceuticals become solid
waste at the healthcare facility.
90
CVS
noted that this is consistent with their
current practice, whereby broken and
leaking items are managed as waste at
their facilities and are not sent through
reverse distribution or reverse logistics.
Although EPA affirms the resulting
settlements and agrees that
nonprescription pharmaceuticals and
other retail items cannot be sent through
reverse logistics when they are broken,
damaged, or leaking, the Agency is
aware that there is inherent uncertainty
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As defined in §
260.10, unpermitted releases
are releases that are not covered by a permit (such
as a permit to discharge to water or air) and may
include, but are not limited to, releases through
surface transport by precipitation runoff, releases to
soil and groundwater, wind-blown dust, fugitive air
emissions, and catastrophic unit failures.
92
These conditions are derived from the
definition of contained as defined in §
260.10.
93
See comment number EPA-HQ-RCRA-2007-
0932-0277 in the docket for this rulemaking.
94
See 49 FR 44978; November 13, 1984.
surrounding when these items are
considered broken, damaged, or leaking.
For example, a nonprescription
pharmaceutical could experience
damage to the outer packaging while the
inner container remains intact. For this
final action, unsold retail items,
including nonprescription
pharmaceuticals, are not considered
waste at the retail store if their
packaging is in good condition, with no
leaks or other continuing or intermittent
unpermitted releases of the materials to
the environment,
91
and they are
contained to prevent releases to the
environment,
92
and they have a
reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for its intended purpose)
or reclaimed. Thus, the Agency intends
that nonprescription pharmaceuticals
and other unsold retail items can be sent
to a reverse logistics center and are not
considered wastes at the retail store if
they meet this standard. For example, if
an outer cardboard box containing vials
of nonprescription pharmaceuticals is
damaged, but the vials are intact and not
damaged or leaking, EPA does not
consider the item to be damaged such
that it cannot go through reverse
logistics.
In order to prevent exposures to
personnel, the public, and the
environment, if items are not in good
condition, or are leaking or releasing to
the environment, these items must be
managed as wastes at the stores in
accordance with the applicable
hazardous waste regulations.
Specifically, if the broken, damaged, or
leaking item is a hazardous waste
pharmaceutical, the retail store must
manage it under the streamlined
standards of part 266 subpart P (unless
it is a VSQG for all its hazardous waste).
Otherwise, the retail store would
manage hazardous wastes under the
applicable RCRA regulations, including
part 262 generator regulations.
E. Applicability of the Household
Hazardous Waste Exemption to Retail
Items
One commenter suggested that the
''household hazardous waste'' exclusion
at 40 CFR 261.4(b)(1) apply to retail
items purchased by a customer and
subsequently returned to the retailer.
93
The Agency has already addressed the
issue of retail wastes as part of a
previous rulemaking that responded to
a petition from the American Retail
Federation. As explained in a November
13, 1984, final rule
94
, EPA excluded
household hazardous waste because the
legislative history of RCRA indicated an
intent to exclude such wastes and not
because these wastes can never pose the
risks associated with hazardous wastes.
Additionally, consistent with legislative
history, when evaluating the American
Retail Federation's petition, EPA
determined that it was necessary to
establish two criteria that must be met
to qualify for this exclusion. First, the
waste must be generated by individuals
on the premises of a temporary or
permanent residence and, second, the
waste stream must be composed
primarily of materials found in wastes
generated by consumers in their homes.
In this final rule, EPA denied the
American Retail Federation's petition to
exempt consumer household hazardous
waste generated by retail sources
because these wastes fail to meet both
criteria. The Agency reaffirmed this
position in the Retail Strategy, arguing
that retail goods, including those that
could become wastes when discarded,
do not satisfy the criteria for this
exclusion.
The Agency believes that this
interpretation extends to retail items
purchased by a customer and
subsequently returned to a retail store.
Hazardous waste generated at retail
stores, including retail items purchased
by a customer that are subsequently
returned, does not meet the first
criterion for the household hazardous
waste exemption. Specifically, the
decision to discard does not occur at the
residence, it occurs at the retail store. In
fact, many retail items that are returned
are restocked and sold at the store (e.g.
lawfully redistributed for their intended
purpose) and are not solid wastes.
On the other hand, the Agency notes
that a household pharmaceutical that is
collected from individuals by a
healthcare facility (e.g., retail store) as
part of a DEA pharmaceutical take-back
program maintains the household
hazardous waste exemption as long as it
is not sewered, and is destroyed by a
method that DEA has publicly deemed
in writing to meet their non-retrievable
standard of destruction or combusted at
one of the types of combustors
identified in §
266.506(b). For more
discussion on DEA take-backs of
household pharmaceuticals, please see
section XIV of this preamble.
VII. Scope of the Final Rule
A. What facilities are subject to the final
rule?
This final rule is a sector-based rule
that applies to the management of
hazardous waste pharmaceuticals that
are generated and managed by
healthcare facilities and reverse
distributors. Subsequent sections of the
preamble will discuss in detail the
definitions of these terms, as well as
what provisions of the rule apply to
each type of facility (see section VIII for
a discussion of each definition and
section IX for Applicability). Healthcare
facilities and reverse distributors will
use the regulations finalized under 40
CFR part 266 subpart P in lieu of the
RCRA generator regulations in 40 CFR
part 262 to which they were previously
subject.
B. What facilities are not subject to the
final rule?
1. Pharmaceutical Manufacturers
Part 266 subpart P does not apply to
the management of hazardous waste
pharmaceuticals that are generated by
pharmaceutical manufacturers. A
pharmaceutical manufacturer remains
subject to part 262 and all applicable
RCRA subtitle C regulations for the
management of its hazardous waste,
including its hazardous waste
pharmaceuticals. Pharmaceutical
manufacturers do not face the same
challenges that healthcare facilities
experience when managing hazardous
waste pharmaceuticals in accordance
with the federal RCRA subtitle C
regulations (for an explanation of the
challenges healthcare facilities face, see
discussion in section III of the
preamble). The types of hazardous
waste pharmaceuticals generated by
manufacturers are less variable and
therefore more predictable, and the staff
have the necessary expertise to
determine which pharmaceutical waste
is hazardous waste. However, when any
facility, including a pharmaceutical
manufacturer, meets the definition
found in this proposal for a reverse
distributor, it would be subject to the
final regulations for reverse distributors
with respect to those operations.
2. Households
The Agency emphasizes that the
regulatory requirements in this final
rule do not apply to households that
discard pharmaceuticals.
Pharmaceuticals that are discarded by
households are not regulated as
hazardous waste and are generally
considered municipal solid waste.
While a small percentage of these
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See the household waste exclusion at
§
261.4(b)(1), which is often referred to as the
household hazardous waste or HHW exclusion.
96
See 49 FR 44978; November 13, 1984.
97
See memo November 1, 1988, from Porter to
Regions (RCRA Online #11377).
98
For pharmaceuticals, these collection events
are often referred to as pharmaceutical take-back
events. As used in this preamble, a take-back event
refers to one-day collection events, such as the DEA
bi-annual pharmaceutical take back days, while a
take-back program refers to an ongoing collection
program, such as a DEA-approved collection
receptacle at a retail store.
99
For more information on the safe disposal of
household waste pharmaceuticals, please see:
http://www.fda.gov/Drugs/ResourcesForYou/
Consumers/BuyingUsingMedicineSafely/
EnsuringSafeUseofMedicine/SafeDisposal
ofMedicines/ucm186187.htm.
100
See memo September 26, 2012, Rudzinski to
the Regional RCRA Division Directors (RCRA
Online# 14833).
101
Since pharmaceutical collection programs
typically commingle DEA controlled substances
with non-controlled substances, this requirement is
included in a section of the regulations that pertains
to controlled substances.
102
See 21 CFR part 1308 for a complete list of
controlled substances.
household waste pharmaceuticals meet
the definition of hazardous waste under
RCRA, the federal RCRA hazardous
waste regulations include an exclusion
for all hazardous wastes generated by
households.
95
Thus household
hazardous waste pharmaceuticals-like
other household hazardous wastes-are
not subject to the federal RCRA
hazardous waste regulations.
Despite the fact that household
hazardous wastes are not regulated as
hazardous wastes, it is important to note
that ''EPA excluded household wastes
because the legislative history of RCRA
indicated an intent to exclude such
wastes, though not because they
necessarily pose no hazard.''
96
Some
household products, including
pharmaceuticals, contain ignitable,
corrosive, reactive, or toxic ingredients.
As a result, for household hazardous
waste collected at a household
hazardous waste collection program, the
Agency has historically recommended
that communities operating the
collection programs manage the
collected household hazardous waste as
hazardous waste, even though it is not
required by RCRA.
97
Similarly, the Agency recommends
that, whenever possible, households
utilize pharmaceutical collection events
as the preferred disposal option for their
unwanted pharmaceuticals.
98
For
consumers without access to a
pharmaceutical take-back event, FDA
provides information on the disposal of
unused pharmaceuticals and step-by-
step guidance for disposing of
pharmaceuticals in the household
trash.
99
In a 2012 memo, the Agency
recommended that collected household
waste pharmaceuticals be incinerated-
preferably at a permitted hazardous
waste incinerator, but when that is not
feasible, at a large or small municipal
waste combustor.
100
The Agency
believes that this practice is already
common among collection programs
since one goal of many collection
programs is to divert pharmaceuticals
from municipal landfills. Additionally,
incineration is commonly used to meet
the non-retrievable standard of
destruction required by DEA for
controlled substances collected from
consumers (''ultimate users,'' as DEA
refers to them). The Agency included
this recommendation as a requirement
for household waste pharmaceuticals
that have been collected (see
§
266.506).
101
See section XIV of this
preamble for a detailed discussion of
this provision.
3. Farmers, Ranchers and Fisheries
This final rule is a sector-specific
rulemaking that applies to healthcare
facilities and reverse distributors. As
such, this final rule does not apply other
generators of hazardous waste
pharmaceuticals such as farmers,
ranchers, and fisheries. Although these
businesses might administer
pharmaceuticals to their animals in the
regular course of their business, they
would not fall within the definition of
a healthcare facility or a reverse
distributor. The Agency designed this
final rule to address the unique needs of
the healthcare sector and concluded that
it would not be appropriate to apply it
to all sectors that generate hazardous
waste pharmaceuticals. Other generators
of hazardous waste pharmaceuticals,
such as farmers, ranchers and fisheries,
remain subject to the part 262 generator
regulations. As discussed in detail in
section VIII of this preamble, the
definition of healthcare facility does
include veterinary clinics and
veterinary hospitals.
4. RCRA-Permitted or Interim Status
Treatment, Storage and Disposal
Facilities
This final rule does not affect how
RCRA-permitted or interim status
TSDFs manage hazardous waste
pharmaceuticals at their facilities,
except indirectly when they treat
hazardous waste pharmaceuticals to
meet the land disposal restrictions
(LDRs). See section X.H. of this
preamble for additional detail.
C. Scope of Hazardous Wastes
Addressed by This Final Rule
1. Hazardous Waste Pharmaceuticals
These final regulations pertain only to
those pharmaceutical wastes that are
RCRA hazardous wastes that are
generated by healthcare facilities or
managed by reverse distributors. Under
this rulemaking, EPA has not added
additional pharmaceuticals to the
hazardous waste listings or expanded
the hazardous waste characteristics to
include additional pharmaceuticals.
Although we solicited ideas from
commenters for possible methods or
approaches for regulating additional
pharmaceuticals as hazardous waste,
any action taken to address the
comments we received in response to
this request would be a separate action
taken by the Agency in the future and
is not part of this final rulemaking.
2. Related Federal or State Regulations
The generation, accumulation,
transportation, treatment, storage, and
disposal of hazardous waste
pharmaceuticals are regulated under
RCRA Subtitle C. However, hazardous
waste pharmaceuticals may also be
subject to a number of other statutes and
implementing regulations administered
by state or other federal agencies.
Examples include pharmaceuticals that
are subject to the Controlled Substances
Act and DEA regulations; infectious
pharmaceutical wastes that are subject
to state and local medical waste
regulations; pharmaceuticals with a
radioactive component that are subject
to the Atomic Energy Act (AEA) and
pharmaceuticals that are hazardous
waste as defined in 40 CFR 261.3 that
are subject to OSHA's Hazardous Waste
Operations and Emergency Response
standard. These potentially overlapping
requirements make the appropriate
management of pharmaceutical wastes a
complex matter. The following
discusses the impact of this final rule on
various dually regulated hazardous
waste pharmaceuticals.
a. Controlled substances. Under prior
regulations, any healthcare facility
generating or managing a RCRA
hazardous waste pharmaceutical that is
also a DEA controlled substance listed
in Schedule II-V
102
had to comply with
the RCRA hazardous waste
requirements, as well as the
requirements of the Controlled
Substances Act and DEA regulations.
DEA regulations from 2014 to
implement the Secure and Responsible
Drug Disposal Act of 2010 require that
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Final rule: September 9, 2014; 79 FR 53520.
104
Proposed rule: December 21, 2012; 77 FR
75784, see page 75803; and final rule: September 9,
2014; 79 FR 53520, see page 53548).
105
The NRC regulates radioactive wastes
generated by commercial or non-DOE facilities,
whereas DOE regulates radioactive wastes generated
by DOE facilities.
106
62 FR 62079, 62085; November 20, 1997.
107
70 FR 59402; October 12, 2005.
controlled substances be destroyed so
that they are ''non-retrievable.''
103
In
the preamble to both the proposed and
final DEA rules, DEA stated that
flushing alone will not meet DEA's new
non-retrievable standard.
104
Due to
difficulties associated with managing
these hazardous waste pharmaceuticals
that are also controlled substances, the
Agency is finalizing a conditional
exemption from the RCRA regulatory
requirements for the handful of
pharmaceuticals that are both a RCRA
hazardous waste and a DEA controlled
substance. That is, this final rule
eliminates the dual regulation for RCRA
hazardous waste pharmaceuticals that
are also DEA controlled substances. A
more detailed discussion of this
conditional exemption is found in
section XIV of this final rule.
b. Medical wastes. There are instances
when a hazardous waste pharmaceutical
will also pose a biological hazard. The
healthcare industry often refers to
pharmaceutical wastes that are both
RCRA hazardous and a biological
hazard as ''dual wastes,'' and such
wastes must be managed in accordance
with RCRA and state and/or local
medical waste regulations. As a result,
the healthcare facility must send these
dual wastes to a hazardous waste TSDF
that is also permitted by their state to
accept medical wastes. Some examples
of dual wastes include partially
administered syringes containing
hazardous waste pharmaceuticals (e.g.,
physostigmine) or intravenous (IV) bags
containing residues of a hazardous
waste pharmaceutical that are attached
to the tubing and needles used to
administer the pharmaceutical. The
RCRA hazardous waste pharmaceutical
component of these dual wastes are
included within these final subpart P
management standards so that
healthcare facilities can obtain the
benefits of this new subpart, while
ensuring the hazardous waste
component of the waste is managed
appropriately and ultimately delivered
to RCRA-permitted TSDFs. Healthcare
facilities must still manage the
biological hazard in accordance with
state and/or local medical waste
requirements. EPA notes that
autoclaving alone is not an acceptable
method of treating hazardous wastes
(pharmaceutical or non-pharmaceutical)
that are also medical waste. In addition,
as discussed in section XV of this
preamble, EPA is exempting from RCRA
regulation the residues of hazardous
waste pharmaceuticals remaining in
empty (i.e., fully administered) syringes.
c. Hazardous waste pharmaceuticals
with a radioactive component.
Hazardous waste pharmaceuticals that
also contain a radioactive component
subject to the Atomic Energy Act of
1954 (AEA) (which are often referred to
as ''mixed waste'') are also regulated by
multiple agencies. The hazardous waste
component is regulated under EPA or
the authorized state RCRA Subtitle C
programs, while either the Nuclear
Regulatory Commission (NRC) or the
Department of Energy (DOE) regulates
the radioactive component of the waste
under the AEA.
105
Healthcare facilities
can use this final rule to meet the
obligation of complying with the RCRA
Subtitle C hazardous waste regulations
for hazardous waste pharmaceuticals
while also complying with the
appropriate AEA regulations. Although
we do not believe that anything in this
subpart is inconsistent with the AEA,
§
1006(a) of RCRA states that if the
RCRA requirements are inconsistent
with the AEA requirements, then the
RCRA requirements do not apply.
Therefore, if a healthcare facility that
manages hazardous waste
pharmaceuticals encounters specific
RCRA requirements that are
inconsistent with specific AEA
requirements, only the AEA
requirements would apply.
As is discussed in the Joint NRC/EPA
Guidance on Testing Requirements for
Mixed Radioactive and Hazardous
Waste an inconsistency occurs when
compliance with one statute or set of
regulations would necessarily cause
non-compliance with the other statute
or set of regulations.
106
Relief from the
regulatory inconsistency would be
provided by the AEA requirement
overriding the specific RCRA
requirement. It is important to note,
however, that the determination of an
inconsistency would relieve the
healthcare facility only from compliance
with the specific RCRA requirement(s)
that is deemed inconsistent with the
AEA requirement(s); the healthcare
facility would still be required to
comply with all of the other hazardous
waste pharmaceutical management
standards.
d. Clean Air Act. The combustion of
hazardous waste pharmaceuticals is
subject to both RCRA and to §
112 of the
Clean Air Act. In general, the Clean Air
Act protects human health and the
environment from the harmful effects of
air pollution by requiring reductions in
the emissions of air pollutants. These
pollutants, which are known or
suspected to cause serious health
problems, such as cancer or birth
defects, are referred to as hazardous air
pollutants (HAPs) and include several
metals that are found in
pharmaceuticals, such as selenium,
mercury, and chromium compounds.
Under §
112 of the Clean Air Act, EPA
is required to list categories of major
and area sources of HAPs; EPA has
listed Hazardous Waste Combustors as
one of these categories.
EPA is also required to establish
National Emission Standards for
Hazardous Air Pollutants (NESHAPs)
for the control of HAP emissions from
listed sources. The NESHAPs are to
reflect the maximum degree of
reduction in emissions of HAPs that is
achievable. This is known as
''maximum achievable control
technology'' (MACT) and is based on
emission levels that are achieved by the
best-performing sources within a source
category. On October 12, 2005, EPA
promulgated NESHAP for Hazardous
Waste Combustors that set MACT
standards for HAPs from this source
category.
107
The owner or operator of a
hazardous waste combustor is required
to comply with specific emission
standards that control HAPs to levels
that reflect MACT. These standards vary
based on the type of hazardous waste
combustion source (e.g., incinerator,
cement kiln, boiler), and in some
instances based on the amount of HAPs
that are emitted by the facility (e.g.,
boilers that are area sources can elect to
comply with fewer HAP emission
standards). Generally speaking;
however, hazardous waste combustors
are required to comply with emission
standards for chlorinated dioxins and
furans, mercury, lead, cadmium,
arsenic, beryllium, chromium,
hydrochloric acid/chlorine gas, as well
as particulate matter as a surrogate to
control five additional metals, and
carbon monoxide, hydrocarbon, and
destruction removal efficiency as
surrogates to control nondioxin/furan
organic HAPs.
Hazardous waste combustors may be
subject to more stringent emission
limitations issued under the RCRA
omnibus authority provisions
(§
3005(c)(3)). This is usually where site-
specific circumstances indicate that a
MACT standard is not protective of
health and the environment. In other
words, some hazardous waste
combustors also have a RCRA permit
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Public Law 113-54.
109
https://www.congress.gov/bill/113th-congress/
house-bill/3204/summary/49; accessed September
13, 2017.
110
See sections 585(a) and 585(b)(1) of the FD&C
Act, as amended by the DSCSA.
111
For a more thorough legal analysis of this
issue, see EPA's letter to the Minnesota Pollution
Control Agency, dated April 9, 2015, in the docket
for this rulemaking EPA-HQ-RCRA-2007-0932.
EPA consulted with FDA in the development of this
letter and FDA agrees with the analysis and
conclusions set forth in the letter.
112
RCRA section 3006(b), 42 U.S.C. 6926(b).
113
Morton v. Macari, 417 U.S. 535, 551(1974).
114
The DSCSA uses the term ''drug product.''
limit that further reduces emissions of
certain HAPs (e.g., mercury) beyond that
which is required by the Clean Air Act
MACT standard.
The combustion of pharmaceuticals
that meet the definition of a RCRA solid
waste but do not meet the definition of
RCRA hazardous waste (i.e., non-
hazardous waste pharmaceuticals) is
regulated by §
129 of the Clean Air Act
and implementing regulations. These
regulations established emission limits
for nine substances or mixtures (i.e.,
particulate matter, carbon monoxide,
dioxins/furans, sulfur dioxide, nitrogen
oxides, hydrogen chloride, lead,
mercury, and cadmium, as well as
opacity where appropriate) from several
categories incineration units, including:
municipal waste combustors (MWCs);
hospital, medical and infectious waste
incinerators (HMIWIs); commercial and
industrial solid waste incinerators
(CISWIs); and other solid waste
incinerators (OSWIs). The emission
limits are based on the application of
MACT and reflect the emission levels
achieved by the best performers in each
category.
3. Drug Supply Chain Security Act
On November 27, 2013, the Drug
Quality and Security Act was signed
into law, amending the Federal Food,
Drug and Cosmetic Act (FD&C Act).
108
The Drug Quality and Security Act
consists of two titles: Title I is known
as the Compounding Quality Act and
Title II is known as the Drug Supply
Chain Security Act (DSCSA). The FDA
was given the responsibility of
developing the implementing
regulations for both titles of the Drug
Quality and Security Act. In a summary
of the DSCSA written by the
Congressional Research Service, a
nonpartisan division of the Library of
Congress, it states that the Act
''Establishes requirements to facilitate
the tracing of prescription drug products
through the pharmaceutical supply
distribution chain.''
109
Prior to
enactment of this federal law, several
states had passed similar laws to ensure
the pedigree of the drug supply chain.
Because each state law was slightly
different, it made compliance difficult
for companies operating in multiple
states. As a result, Congress amended
the FD&C Act to add §
585, entitled
Uniform National Policy, which moots
the pedigree laws already in effect (to
the extent they are inconsistent with the
DSCSA) and prevents states (and others)
from enacting inconsistent pedigree
laws in the future. This section, which
was added by the DSCSA, includes sub-
sections that are sometimes referred to
as ''preemption clauses.''
110
Since the DSCSA was signed into law,
some have argued to EPA and RCRA-
authorized states that §
585 of the FD&C
Act (as amended by the DSCSA)
preempts all state hazardous waste
regulatory authority as it may relate to
the documentation of the disposition of
hazardous waste pharmaceuticals. EPA
disagrees with this interpretation of the
DSCSA. Section 585 specifically avoids
preempting state requirements, such as
RCRA hazardous waste laws, that are
unrelated to the tracing of products
within the prescription drug
distribution supply chain and other
issues expressly addressed by the
DSCSA. As stated in §
585(c), ''Nothing
in this section shall be construed to
preempt State Requirements related to
the distribution of prescription drugs if
such requirements are not related to
product tracing as described in
subsection (a) or wholesale distributor
and third-party logistics provider
licensure as described in subsection (b)
applicable under §
503(e) (as amended
by the Drug Supply Chain Security Act)
or this subchapter (or regulations issued
thereunder)'' (emphasis added).
This provision makes clear that §
585
applies only to state requirements
related to distribution of prescription
drugs and only to the extent that these
requirements are related to product
tracing or other issues specifically
addressed by the DSCSA, such as
licensure. Thus, as EPA interprets §
585,
it would not apply to state requirements
related to documentation of RCRA
hazardous waste management activities,
including disposal, because those
activities are distinct and unrelated to
the product tracing and other
requirements of the DSCSA.
And indeed, in EPA's consultation
with FDA on this issue, FDA agreed
with EPA's conclusion that §
585 does
not preempt state hazardous waste
regulations related to the documentation
of the management of hazardous waste
pharmaceuticals. EPA's position is
based upon our review of both the direct
language and intent of the statute.
111
To understand the connection
between state hazardous waste
regulations and the DSCSA, it is
important to understand the
relationship between the federal and
state hazardous waste regulations. The
federal RCRA program is implemented
by state RCRA programs that are
authorized by EPA under RCRA section
3006, 42 U.S.C. 6926. Authorized state
hazardous waste regulations must, at a
minimum, be equivalent to federal
RCRA hazardous waste regulations.
Under RCRA, EPA authorizes state
hazardous waste programs to operate in
lieu of the federal hazardous waste
program.
112
Authorized state
requirements are federally enforceable
as requirements under RCRA Subtitle C.
Nothing in the DSCSA indicates that
Congress intended to impliedly repeal
federal RCRA requirements. Such an
implied repeal would leave gaps in
RCRA coverage and result in no
hazardous waste regulations of any
kind-federal or state-applying to the
documentation of the management of
hazardous waste pharmaceuticals.
Given that (i) there is no indication of
Congressional intent to repeal
hazardous waste documentation
regulations via the DSCSA (indeed,
there is no mention of hazardous waste
in the DSCSA at all), and (ii) §
585(c) of
the FD&C Act, as added by the DSCSA,
expressly notes the limits of the statute's
preemptive effect, we believe it is clear
that Congress did not intend to
impliedly repeal RCRA authorized state
hazardous waste requirements as they
apply to the documentation of the
management, including disposal, of
hazardous waste pharmaceuticals. The
general rule enunciated by the U.S.
Supreme Court is that ''when two
[federal] statutes are capable of co-
existence, it is the duty of the courts,
absent a clearly expressed congressional
intention to the contrary, to regard each
as effective.''
113
Here, both RCRA and
the DSCSA coexist easily, because
neither the language nor the purpose of
the DSCSA is in conflict with RCRA.
In addition, some commenters have
argued that, in the case of nonsaleable
pharmaceutical products, DSCSA
requirements preempt RCRA
requirements and that nonsaleable
pharmaceutical products are regulated
exclusively by the FDA pursuant to the
provisions of the DSCSA.
114
Commenters have also argued that
under the DSCSA, nonsaleable
pharmaceutical products that are sent
from wholesale distributors, dispensers,
and repackagers as nonsaleable may be
sent to a returns processor reverse
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Section 585(a) of the DSCSA contains a
preemption provision for state requirements for
tracing drug products through the distribution
system. Section 585(b) of the DSCSA contains a
preemption provision for state requirements for
wholesale prescription drug distributors and third-
party logistics providers.
116
See 42 U.S.C. 6902(b).
117
August 2017, docket number FDA-2017-D-
1956.
118
See page 6 of comment FDA-2017-D-1956-
0013.
119
See page 7 of comment FDA-2017-D-1956-
0013.
120
See page 14 of comment FDA-2017-D-1956-
0011.
121
See notes from site visit to Med-Turn, October
10, 2017 in the docket for this rulemaking EPA-
HQ-RCRA-2007-0932. Med-Turn is a subsidiary of
Inmar.
122
See Section 3 of Attachment A of memo
entitled Checklist to Assist in Evaluating Whether
Commercial Chemical Products or Solid and
Hazardous Waste Under the Resource Conservation
and Recovery Act, May 14, 2013, Devlin to RCRA
Division Directors, RCRA Online #14837.
123
On June 30, 2017, FDA issued a draft
guidance, Product Identifier Requirements Under
the Drug Supply Chain Security Act-Compliance
Policy. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM565272.pdf.
124
The DSCSA was enacted on November 27,
2013; therefore, the 3PL licensing regulations were
scheduled to be issued by FDA by November 27,
2015.
125
August 2017, Identifying Trading Partners
Under the Drug Supply Chain Security Act-
Guidance for Industry. https://www.fda.gov/
downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM572252.pdf.
126
See the Spring 2018 Unified Agenda, available
at https://www.reginfo.gov/public/do/
eAgendaMain.
logistics provider for handling as
products. These commenters believed
that, at a minimum, the mere fact that
a pharmaceutical product becomes
nonsaleable does not mean that such
pharmaceutical product is now a solid
waste under the RCRA hazardous waste
regulations.
EPA does not agree with these
comments. The preemption provisions
added to the FD&C Act by the DSCSA-
both §
585(a) and §
585(b)-only apply
to the protection of the drug supply
chain and do not apply to waste
management requirements under
RCRA.
115
Under RCRA, EPA regulates
pharmaceuticals differently than FDA
does under the DSCSA since the goals
of the statutes serve different purposes.
The purpose of the DSCSA is to protect
the security, pedigree, and quality of
pharmaceutical products in the drug
supply chain. One of the many purposes
of RCRA is to ensure that any waste that
is generated is ''treated, stored or
disposed of so as to minimize the
present and future threat to human
health and the environment.''
116
In
addition, we note that the DSCSA
applies only to prescription drug
products (not to OTC drug products), so
there can be no conflict between DSCSA
and RCRA for nonsaleable OTC drug
products.
As explained in further detail
throughout this preamble, whether a
pharmaceutical has monetary value
(such as when it receives manufacturer
credit) is not determinative of whether
it is a waste under RCRA. Under RCRA,
one considers whether a material is
discarded-and not whether it receives
credit, or holds value or no value-to
determine whether it is waste. Thus,
prescription pharmaceuticals that are
sent by healthcare facilities to reverse
distributors and that will be discarded
(even if these pharmaceuticals receive
credit) will first be considered wastes at
the healthcare facility when the
decision is made by the healthcare
facility to send them to a reverse
distributor.
Furthermore, EPA disagrees with
commenters that a nonsaleable
pharmaceutical product sent to reverse
distributors should not be considered a
waste. Nonsaleable pharmaceutical
products sent to reverse distributors are
not sent for reuse or donation, but are
sent for disposal, and thus would be
considered wastes at the healthcare
facility. In its comments to the FDA on
the Draft Guidance for Industry,
Identifying Trading Partners Under the
Drug Supply Chain Security Act,
117
an
industry trade association appears to
confirm this point when it says, ''Most
fundamentally, returns processors are
unlike the trading partners described in
the DSCSA. Trading partners are
dedicated to moving products forward
for dispensing and administration to
patients. Returns processors' activities
come at the end, when the product is no
longer retained for distribution or
dispensing and is safely removed from
the supply chain.''
118
The commenter
goes on to say that ''the assumptions
that product is being distributed for
further use, rather than only for credit
assessment and/or disposition'' do not
appear to apply to returns processors
(known as reverse distributors in this
final rule.
119
Similarly, a reverse
distributor also submitted comments to
the FDA on the same draft guidance,
stating that ''once these products reach
the returns processors for creditability
assessment and final disposition
management, they are forever removed
from commerce.''
120
Furthermore,
during a site visit to a large reverse
distributor, EPA was told that none of
the pharmaceuticals on site would be
donated or redistributed or otherwise
returned to commerce.
121
After they are
evaluated for manufacturer credit, the
pharmaceuticals are sent for
incineration. Under §
261.2(b)(3) of the
RCRA regulations, ''Materials are solid
waste if they are abandoned by being
.
.
. Accumulated, stored, or treated
(but not recycled) before or in lieu of
being abandoned by being disposed of,
burned, or incinerated.'' The
pharmaceuticals at reverse distributors
are being accumulated prior to being
incinerated and therefore are solid
wastes. Additionally, in a 2013 memo
EPA includes a series of questions to
help determine whether a commercial
chemical product is a solid and
hazardous waste. One set of questions
relates to whether the facility appears to
be selling into commerce the material
being evaluated. If the facility has no
customers or market for the material, it
can be an indication that the material is
a solid waste.
122
As explained elsewhere in the
preamble, EPA distinguishes between
reverse distributors (as defined in this
rule) and reverse logistics centers.
Reverse distributors do not reuse or
donate, but in fact, dispose of the
pharmaceuticals they receive. In sum,
what DSCSA would consider to be a
nonsaleable product is still considered
to be a solid waste under RCRA when
it is discarded according to the RCRA
regulations, and the DSCSA does not
preclude pharmaceuticals from being
waste under RCRA.
EPA notes that many of the
implementing regulations for the
DSCSA are still under development by
the FDA and the FDA has announced
that it is delaying enforcement of certain
requirements.
123
Section 584(d) of the
FD&C Act, as added by the DSCSA,
directs the FDA to issue licensing
regulations for third party logistics
providers (3PLs) within two years of the
date of enactment of the DSCSA.
124
Draft FDA guidance issued in August
2017 indicates that FDA plans to
consider a returns processor or reverse
logistics provider to be a type of 3PL.
125
However, FDA has not yet finalized this
guidance or issued proposed or final
regulations for licensing 3PLs. The
listing for the relevant regulation in the
most recent version of the public list of
planned federal rulemaking (the Unified
Agenda of Regulatory and Deregulatory
Actions, or ''Unified Agenda'') indicates
that FDA plans to issue a proposed
DSCSA licensing regulation within the
next year.
126
Furthermore, since 3PLs, such as
reverse logistics providers, do not take
ownership of the drugs that they
manage at their facilities, the DSCSA
requirements related to tracing drugs
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See, for example, https://www.cdc.gov/niosh/
review/peer/isi/hazdrug2018-pr.html or NIOSH
[2016]. NIOSH list of antineoplastic and other
hazardous drugs in healthcare settings, 2016. By
Connor TH, MacKenzie BA, DeBord DG, Trout DB,
O'Callaghan JP. Cincinnati, OH: U.S. Department of
Health and Human Services, Centers for Disease
Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH)
Publication Number 2016-161 (Supersedes 2014-
138). https://www.cdc.gov/niosh/docs/2016-161/
pdfs/2016-161.pdf.
128
Practice Greenhealth, Revised August 2008.
Published in 2006, the development of the original
Blueprint was funded by the Office of Solid Waste
and Emergency Response and managed by EPA
Region 1. The 2008 revision of the Blueprint was
funded by the Healthcare Environmental Resource
Center. http://practicegreenhealth.org/sites/default/
files/upload-files/pharmwasteblueprint.pdf.
129
As noted in the comment after §
261.33(d), the
phrase ''commercial chemical product'' includes
formulations in which the P- or U-listed chemical
is the sole active ingredient. Therefore,
formulations with more than one active ingredient
do not meet the specifications of the P- and U-
listings even if one, two or all of the active
ingredients are listed on the P- and/or U-lists.
130
The descriptions ''bulk'' and ''trace'' when
applied to chemotherapeutic wastes are industry
terms and are not defined by the federal RCRA
regulations.
131
See NIOSH list of antineoplastic and other
hazardous drugs in healthcare settings, 2016. By
Connor TH, MacKenzie BA, DeBord DG, Trout DB,
O'Callaghan JP. Cincinnati, OH: U.S. Department of
Health and Human Services, Centers for Disease
Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH)
Publication Number 2016-161 (Supersedes 2014-
138). https://www.cdc.gov/niosh/docs/2016-161/
pdfs/2016-161.pdf.
through the supply chain, including
transaction information (TI), transaction
history (TH), and transaction statements
(TS), do not apply to them. In the
absence of relevant FDA regulations, it
is difficult for EPA to consider the
possibility of deferring to FDA for the
regulation of reverse distributors, who
we consider to be managing hazardous
wastes. In the future, if there are
duplicative regulations, EPA may need
to revisit the regulation of reverse
distributors after the FDA issues
proposed and final licensing regulations
for 3PLs in accordance with the DSCSA.
D. Wastes Generated at Healthcare
Facilities That Are Not Included in the
Scope of This Final Rule
Wastes that are not included in the
scope of this proposed rulemaking
include non-hazardous wastes and non-
pharmaceutical hazardous wastes.
Pharmaceutical wastes that are not
listed or characteristic hazardous wastes
under RCRA Subtitle C may nonetheless
pose some risks to public health and the
environment. These wastes are
discussed further below.
1. How should non-hazardous waste
pharmaceuticals be disposed?
A large portion of the pharmaceutical
wastes generated at healthcare facilities
will not meet the definition of a RCRA
hazardous waste under RCRA Subtitle
C. This final rule, therefore, does not
require that healthcare facilities manage
these waste pharmaceuticals under the
RCRA Subtitle C hazardous waste
regulations, including this final rule.
However, a healthcare facility may
choose to manage its non-hazardous and
hazardous waste pharmaceuticals
together (as hazardous waste
pharmaceuticals) under the new subpart
P regulations. Because all healthcare
facilities operating under this subpart
are regulated in the same way regardless
of quantity of hazardous waste
pharmaceuticals generated, managing
non-hazardous waste pharmaceuticals
as hazardous waste under this subpart
would not affect the facility's hazardous
waste generator category. While not
regulated by the federal RCRA
hazardous waste requirements, non-
hazardous waste pharmaceuticals that
are not managed under subpart P are
still considered solid wastes under the
federal regulations and must be
managed in accordance with applicable
federal, state, and/or local regulatory
requirements. Moreover, some waste
pharmaceuticals that do not qualify as
''hazardous wastes'' under RCRA can
nonetheless be extraordinarily
hazardous thus, extreme care may be
warranted.
127
These are discussed
below in section VII.D.1.a.
If a healthcare facility decides to
segregate its hazardous and non-
hazardous waste pharmaceuticals, EPA
recommends that healthcare facilities
follow the best management practices
(BMPs) outlined in ''Managing
Pharmaceutical Waste: A 10-Step
Blueprint for Healthcare Facilities in the
United States,'' (Blueprint)
128
an EPA
guidance document for the
management, treatment, storage and
disposal of non-hazardous waste
pharmaceuticals. The following
summarizes the recommended BMPs
found in the Blueprint for various
categories of pharmaceutical wastes,
including those wastes that possess
hazardous waste-like qualities yet are
not regulated as hazardous waste under
RCRA Subtitle C.
a. Recommended best management
practices for healthcare facilities
managing non-hazardous waste
pharmaceuticals possessing hazardous
waste-like qualities. Currently, most
pharmaceuticals are not regulated as
RCRA hazardous wastes when
discarded by healthcare facilities. These
''non-RCRA-hazardous''
pharmaceuticals can be divided into
two categories: Those that possess
hazardous waste-like qualities and those
that do not. As outlined in the
Blueprint, there are pharmaceuticals
that possess hazardous waste-like
qualities, but for various reasons, are not
regulated by the RCRA Subtitle C
hazardous waste regulations. The
Agency supports the Blueprint's
recommendation of hazardous waste
incineration as the BMP for healthcare
facilities and reverse distributors
discarding pharmaceuticals that may
possess hazardous waste-like qualities,
but are not regulated as RCRA
hazardous waste. This recommendation
would apply to pharmaceuticals with
more than one active ingredient listed
on the P- or U-lists,
129
chemotherapeutic agents characterized
as bulk wastes,
130
pharmaceuticals
which meet the hazardous drug criteria
set by the National Institute for
Occupational Safety and Health
(NIOSH),
131
pharmaceuticals with
LD50s ≤ 50 mg/kg, pharmaceuticals that
are carcinogenic or endocrine disrupting
compounds, and vitamin/mineral
preparations containing heavy metals.
b. Recommended best management
practices for other non-hazardous waste
pharmaceuticals (not possessing
hazardous waste-like qualities). As far
as other non-hazardous waste
pharmaceuticals (i.e., those not
possessing hazardous waste-like
qualities), disposing of non-hazardous
waste pharmaceuticals at healthcare
facilities via drain disposal is strongly
discouraged and not recommended by
EPA. Therefore, EPA endorses the
Blueprint's recommendation of
municipal solid waste incineration or
medical waste incineration for any non-
hazardous waste pharmaceuticals, even
when they do not possess hazardous
waste-like qualities. The potential risk
remains for active pharmaceutical
ingredients (APIs) to be released into the
environment if medical waste
autoclaves or municipal solid waste
landfills are used for the purposes of
pharmaceutical waste treatment and
disposal. For example, autoclaves are
designed to kill pathogens and do not
achieve the temperatures required to
destroy most APIs during the
autoclaving process. As a result, when
wastewater is generated either by
cleaning an autoclave, or during
automatic blow down from autoclaves
equipped with steam generators, there is
the potential for wastewater containing
APIs to be generated and discharged
into the sewer. In addition, some
limited studies have shown APIs
present in landfill leachate collected in
municipal solid waste landfill leachate
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Barnes, K.K., Christenson, S.C., Kolpin, D.W.,
Focazio, M.J., Furlong, E.T., Zaugg, S.D., Meyer,
M.T. and Barber, L.B. (2004), Pharmaceuticals and
Other Organic Waste Water Contaminants Within a
Leachate Plume Downgradient of a Municipal
Landfill. Groundwater Monitoring & Remediation,
24: 119-126
133
Buszka, P.M., Yeskis, D.J., Kolpin, D.W.,
Furlong, E.T., Zaugg, S.D., and Meyer, M.T. (June
2009), Waste-Indicator and Pharmaceutical
Compounds in Landfill-Leachate-Affected Ground
Water near Elkhart, Indiana, 2000-2002. Bulletin of
Environmental Contamination and Toxicology,
V82.6:635-659.
134
See comment number 0257 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
135
See comment number 0235 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
136
See comment numbers 0238 and 0264 in the
docket for this rulemaking (EPA-HQ-RCRA-2007-
0932).
137
See comment number 0295 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
systems.
132
133
Typically, the collected
landfill leachate is subsequently sent to
wastewater treatment plants for
treatment, but their treatment
technologies are not designed to remove
all APIs from the wastewater (See
section XIII for more information
regarding the prohibition on sewering
hazardous waste pharmaceuticals).
2. How should non-pharmaceutical
hazardous waste be disposed?
These newly promulgated subpart P
regulations will pertain only to
hazardous waste pharmaceuticals.
Therefore, other types of hazardous
wastes generated at healthcare facilities
and reverse distributors that do not meet
the definition of a hazardous waste
pharmaceutical cannot be managed in
accordance with this new subpart (as
previously discussed, non-hazardous
waste pharmaceuticals may be managed
under this new subpart). For example,
hazardous wastes generated in hospital
laboratories or during cleaning and
maintenance of the facility are not
considered hazardous waste
pharmaceuticals and are not included
within the scope of this final rule. The
generation of non-pharmaceutical
hazardous wastes is often more routine
and does not trigger the same concerns
that healthcare facilities experience
when managing hazardous waste
pharmaceuticals. Also note that the
2016 Hazardous Waste Generator
Improvements final rule added new
flexibility for episodic generators of
non-pharmaceutical hazardous waste
under part 262 subpart L.
VIII. What terms are defined in this
final rule? (§
266.500)
A. Definition of Pharmaceutical
1. Summary of Proposal
EPA proposed to define
''pharmaceutical'' as any chemical or
biological product that is intended for
use in the diagnosis, cure, mitigation,
care, treatment, or prevention of disease
or injury of a human or other animal; or
any chemical or biological product that
is intended to affect the structure or
function of the body of a human or other
animal. This definition included, but
was not limited to dietary supplements
as defined by the Federal Food, Drug,
and Cosmetic Act (FD&C Act),
prescription drugs, OTC drugs, residues
of pharmaceuticals remaining in
containers, personal protective
equipment contaminated with residues
of pharmaceuticals, and clean-up
material from the spills of
pharmaceuticals. This proposed
definition of ''pharmaceutical'' was
intended to include all dose forms,
including, but not limited to, tablets,
capsules, medicinal gums or lozenges,
medicinal liquids, ointments and
lotions, IV or other compound solutions,
chemotherapy pharmaceuticals,
vaccines, allergenics, medicinal
shampoos, antiseptics, and any delivery
device, including medicinal dermal
patches, with the primary purpose to
deliver or dispense the pharmaceutical.
EPA relied on the FD&C Act's
definition of ''drug'' to develop the
proposed definition of
''pharmaceutical'' but expanded on the
definition based on comments to the
2008 Universal Waste proposed
rulemaking. In particular, stakeholders
requested that the Agency take a broad
view in delineating what items are
included in the definition of
pharmaceutical so that the proposed
standards applied broadly. Thus, the
proposed definition of
''pharmaceutical'' did not exclude
pharmaceuticals with a radioactive
component and included items not
specifically recognized by the FDA as
drugs, such as dietary supplements,
pharmaceutical residues in non-empty
containers (including delivery devices),
personal protective equipment
contaminated with residues of
pharmaceuticals, and clean-up material
from spills of pharmaceuticals.
2. Summary of Comments
The most frequent comment EPA
received on the definition of
''pharmaceutical'' was on the inclusion
of personal protective equipment and
clean-up material in the definition of
pharmaceutical. Many commenters
argued that personal protective
equipment and clean-up material
should not be included in the final
definition. One commenter suggested
that loose tablets be included in the
definition of pharmaceutical but that
personal protective equipment should
not be included. Waste Management
National Services, Inc. suggested that
only ''overtly contaminated'' personal
protective equipment or clean-up
materials be included in the definition,
but not personal protective equipment
and clean-up materials with trace
contamination.
134
Two commenters
asked EPA to clarify which personal
protective equipment is included in the
definition of ''pharmaceutical.''
One state expressed concern that EPA
proposed to take a broad view in
delineating what items are included in
the definition of ''pharmaceutical.'' The
New Jersey Department of
Environmental Protection pointed out
that although ''sharps'' did not meet the
proposed definition of
''pharmaceutical'' that IV bags, tubing
and syringes that come in contact with
blood or pathogens could fall under the
definition of ''pharmaceutical.'' They
asked that EPA exclude these items
from the definition.
135
EPA requested comment on the
Agency's decision to include dietary
supplements in the definition of
''pharmaceutical'' under the final rule.
Four states and one industry association
supported the Agency's proposal to
include dietary supplements under the
definition of ''pharmaceutical.'' One
state and five industry associations did
not support including dietary
supplements in the definition of
''pharmaceutical.'' Multiple commenters
requested that EPA only include dietary
supplements that are regulated as drugs
and exclude supplements regulated as
foods.
EPA requested comment on the
possibility of including low-
concentration nicotine products, such as
electronic nicotine delivery systems (e-
cigarettes), in the definition of
''pharmaceuticals'' under the final rule.
EPA received multiple comments on
whether to include e-cigarettes and
liquid nicotine (e-liquids) in the final
definition. Hawaii State Department of
Health and the Hematology/Oncology
Pharmacy Association did not support
including e-cigarettes or e-liquids in the
final definition of ''pharmaceutical.''
136
RILA requested that EPA exempt all
low-concentration nicotine products
from the P075 listing, including e-
cigarettes and e-liquids, but agreed that
if EPA did not exempt these products
from the P075 listing, that e-cigarette
products should fall under the
definition of ''pharmaceutical.''
137
The American Dental Association
asked that EPA specifically exclude
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See comment number 0294 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
139
See comment numbers 0246, 0280, 0296 in the
docket for this rulemaking (EPA-HQ-RCRA-2007-
0932).
140
See comment number 0280 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
141
See comment numbers 0246, 0280, 0296 in the
docket for this rulemaking (EPA-HQ-RCRA-2007-
0932).
142
See 21 CFR 201.66
143
See memo from Lowrance to Fields, January
3, 1989 (RCRA Online #11387).
144
Including dietary supplements under the
definition of ''pharmaceutical'' does not supersede
the requirements of the Dietary Supplement Health
and Education Act of 1994, the Federal Food, Drug
and Cosmetic Act, or FDA regulations.
145
The substance of the definition is: A Product
(other than tobacco) intended to supplement the
diet that bears or contains one or more of the
following dietary ingredients: (A): A vitamin; (B) a
mineral; (C) an herb or other botanical; (D) an
amino acid; (E) a dietary substance for use by man
to supplement the diet by increasing the total
dietary intake; or (F) a concentrate, metabolite,
constituent, extract, or combination of any
ingredient described in clause (A), (B), (C), (D), or
(E); For the complete definition of dietary
supplement, please see: https://www.gpo.gov/fdsys/
pkg/USCODE-2011-title21/pdf/USCODE-2011-
title21-chap9-subchapII.pdf.
146
See 21 CFR 101.36.
dental amalgam from the final definition
of ''pharmaceutical.''
138
Multiple commenters pointed out that
the same chemical may have a
pharmaceutical and non-pharmaceutical
use (e.g., isopropyl alcohol is used to
clean wounds and to clean instruments
and surfaces).
139
Commenters asked
EPA to clarify that they are regulated
differently.
Stericycle, Inc. requested that
investigational or research drugs be
considered pharmaceuticals because
they are difficult to characterize.
140
3. Final Rule Provisions
In this final rule, ''pharmaceutical''
means any drug or dietary supplement
for use by humans or other animals; any
electronic nicotine delivery system (e.g.,
electronic cigarette or vaping pen), or
any liquid nicotine (e-liquid) packaged
for retail for use in electronic nicotine
delivery systems (e.g., pre-filled
cartridges or vials). This definition
includes, but is not limited to dietary
supplements, as defined by the Federal
Food, Drug and Cosmetic Act;
prescription drugs, as defined by 21
CFR 203.3(y); OTC drugs; homeopathic
drugs; compounded drugs;
investigational new drugs;
pharmaceuticals remaining in non-
empty containers; personal protective
equipment contaminated with
pharmaceuticals; and clean-up material
from spills of pharmaceuticals. This
definition does not include dental
amalgam or sharps.
The final definition of pharmaceutical
includes both prescription drugs, as
defined by 21 CFR 203.3(y) and OTC
drugs. As previously mentioned,
commenters pointed out that the same
chemical may have a pharmaceutical
and non-pharmaceutical use.
141
If an
OTC product is required by the FDA to
include ''Drug Facts'' on the label, it
would be considered a pharmaceutical
for the purposes of this rule.
142
In rare
cases, some items that are OTC
pharmaceuticals may not be labeled
appropriately with a ''Drug Facts'' label.
It is the Agency's understanding,
however, that all OTC drugs must
contain a Drug Facts label. Therefore, if
an item meets the criteria to be
considered a pharmaceutical under
subpart P but is not labeled with Drug
Facts, it should still be managed as a
pharmaceutical. Any non-
pharmaceutical hazardous wastes must
be managed pursuant to all other
applicable RCRA regulations. The final
definition of ''pharmaceutical'' also
includes any pharmaceutical residuals
remaining in non-empty containers,
such as the pharmaceutical residuals
remaining in dispensing bottles, IV bags
and tubing, vials, unit dose packages,
and delivery devises, such as syringes
and patches. However, the final
definition does not include sharps (e.g.,
needles from IV bags or syringes). Used
sharps, such as needles or syringes with
needles, are not included under the
final definition of pharmaceutical
because sharps are considered medical
wastes, presently regulated at both the
state and local level. Further, as
discussed in section XV of this
preamble, EPA is finalizing regulations
for when pharmaceutical containers are
considered empty.
The final definition of
''pharmaceutical'' also includes items
contaminated with or containing
pharmaceuticals, such as personal
protective equipment contaminated
with pharmaceuticals or related spill
clean-up materials (including loose
tablets accumulated during pharmacy
floor sweepings). EPA's decision to
include contaminated personal
protective equipment under the
definition of ''pharmaceutical'' reflects
the Agency's interest in promoting a
similar management scheme for the
personal protective equipment
containing pharmaceuticals and other
types of pharmaceuticals. Only personal
protective equipment that is already
considered hazardous waste under the
''contained in'' policy because it is
contaminated with pharmaceuticals will
fall under the definition of
pharmaceutical.
143
These items are
included in the definition so that
facilities can manage more types of
hazardous waste commonly found in
healthcare settings under the same
standards. For example, the contained
in policy would not apply to gloves that
have touched a warfarin pill during the
course of patient care. However, if a
healthcare worker spills a hazardous
waste pharmaceutical on their personal
protective equipment and it cannot be
removed from the personal protective
equipment, the personal protective
equipment would be considered a
hazardous waste pharmaceutical. If the
personal protective equipment only has
trace amounts of contamination it
would not be considered a hazardous
waste and therefore not be considered a
hazardous waste pharmaceutical.
The final definition of
''pharmaceutical'' includes dietary
supplements for the same reason-in
order to promote a consistent
management scheme for similar waste
streams. Dietary supplements are
commonly found in various healthcare
settings because they are recommended
or prescribed by healthcare providers to
patients.
144
Further, retail pharmacies
routinely sell vitamins and other
medicinal minerals and supplements.
When EPA uses the term ''dietary
supplements'' in the definition of
''pharmaceutical,'' EPA is referencing
the definition for dietary supplement
used by the FD&C Act, as amended by
the Dietary Supplement Health and
Education Act of 1994 (21 U.S.C. 321
(ff)).
145
If a dietary supplement is
required by the FDA to include a
''Supplement Facts'' panel on the label,
it would be considered a
pharmaceutical for the purposes of this
rule.
146
The FD&C Act categorizes
dietary ingredients and dietary
supplements under the general umbrella
of foods and therefore does not review
them before being marketed. In fact,
several commenters suggested that
because the FD&C Act does not regulate
supplements as drugs, EPA does not
have the authority to regulate them as
pharmaceuticals under RCRA. EPA
disagrees with the commenters, noting
that any waste that is listed or exhibits
a characteristic is regulated as a
hazardous waste when discarded,
including supplements. This final rule
does not newly apply RCRA to the
disposal of supplements that meet the
definition of hazardous waste, as some
commenters suggest; it changes which
regulations apply when discarding
supplements that are hazardous waste.
EPA recognizes that healthcare facilities
may benefit from managing dietary
supplements along with drugs under the
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82 FR 27154; June 14, 2017.
148
26 U.S.C. 5702 (d)
149
This distinction is adapted from the term
''finished tobacco product'' used by FDA in its
regulations for e-cigarettes, cigars, and all other
tobacco products. 81 FR 28973; May 10, 2016.
150
See comment number 0211 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
151
See comment number 0247 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
152
See comment number 0321 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
153
See comment number 0257 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
final regulation, and thus, is including
it in the final definition of
''pharmaceutical.'' Although dietary
supplements are considered
pharmaceuticals under this definition,
only the dietary supplements that meet
the definition of hazardous waste (e.g.,
exhibits the toxicity characteristic for
metal content) would be regulated
under part 266 subpart P as hazardous
waste pharmaceuticals (see the
definition of ''hazardous waste
pharmaceutical'').
The final rule specifically excludes
dental amalgam from the final definition
of pharmaceutical. EPA promulgated
new pretreatment standards in June
2017 to reduce discharges of mercury
from dental offices into publicly owned
treatment works.
147
If EPA included
dental amalgam in the final definition of
pharmaceutical, it would subject
dentists to duplicative regulatory
requirements.
The final definition of
''pharmaceutical'' includes electronic
nicotine delivery systems and liquid
nicotine (e-liquid) packaged for retail for
use in electronic nicotine delivery
systems. These items are included in the
definition ''pharmaceutical'' so that
facilities can manage more types of
hazardous waste commonly found in
healthcare settings under part 266
subpart P. The final definition of
''pharmaceutical'' applies to finished
product electronic nicotine delivery
systems, including components and
parts, sealed in final packaging intended
for consumer use (e.g., electronic
cigarettes and vaping pens) and e-liquid
that is packaged for retail for use in the
electronic nicotine delivery systems
(e.g., pre-filled cartridges and vials that
are sold separately to consumers or as
part of kits). EPA intends that e-liquid
used by manufacturers of tobacco
products (as defined by the FD&C Act)
not be included in the final definition
of ''pharmaceutical.''
148
That is, a pre-
filled e-liquid cartridge sealed in final
packaging that is to be sold or
distributed to a consumer for use is
included in the definition, but in
contrast, an e-liquid that is sold or
distributed for further manufacturing,
mixing, or packaging into a finished
electronic nicotine delivery system is
not included.
149
EPA believes that
finished products sealed in packaging
intended for consumer use pose a lower
risk for leaks and other releases to the
environment than e-liquid that is sold or
distributed for further manufacturing. E-
liquid that is packaged for retail for use
in electronic nicotine delivery systems,
such as e-liquid that is in pre-filled
cartridges and vials, is typically sold at
lower concentrations and smaller
quantities than e-liquid that is sold or
distributed for further manufacturing.
The final definition of
''pharmaceutical'' includes
investigational drugs. One commenter
asked EPA to include investigational
drugs in the definition because these
drugs are difficult to characterize. The
investigational drugs might have
proprietary ingredients that the
manufacturer might not be willing to
divulge during trials. The final
definition includes investigational drugs
in order to provide clarity on how to
manage these items when discarded.
See section IX.B.2.e regarding the
applicability of subpart P to discarded
investigational drugs.
B. Definition of Hazardous Waste
Pharmaceutical
1. Summary of Proposal
EPA proposed to define ''hazardous
waste pharmaceutical'' as a
pharmaceutical that is a solid waste, as
defined in §
261.2, and is listed in part
261 subpart D, or exhibits one or more
characteristics identified in part 261
subpart C. The Agency proposed to
define the term ''hazardous waste
pharmaceutical'' in order to clarify its
intent that only pharmaceuticals that
meet the definition of hazardous waste
when disposed or discarded need to be
managed under the new subpart P
management standards.
2. Summary of Comments
EPA requested comment on the
proposed definition of ''hazardous
waste pharmaceutical'' and specifically
on whether any dietary supplements
currently on the market meet or could
potentially meet RCRA's definition of
hazardous waste.
The New Mexico Environment
Department requested that EPA broaden
the definition of ''hazardous waste
pharmaceutical'' to include
antineoplastic agents. The New Mexico
Environment Department argued that
EPA has not updated the P- and U-
hazardous waste lists even though new
pharmaceuticals have been developed
that should be considered hazardous
waste.
150
Public Employees for
Environmental Responsibility also
argued that the definition of ''hazardous
waste pharmaceutical'' is too narrow
because not enough pharmaceuticals
meet the definition.
151
American
Pharmacists Association expressed
concern that the definition is difficult to
understand because the P- and U-
hazardous waste lists are not
comprehensive.
152
Waste Management National Services
Inc., supported the proposed definition
of ''hazardous waste pharmaceutical''
and pointed out that there are dietary
supplements on the market that meet
the RCRA definition of hazardous waste
because the supplements contain
selenium or chromium.
153
3. Final Rule Provisions and Response
to Comments
In this final rule, ''hazardous waste
pharmaceutical'' means a
pharmaceutical that is a solid waste, as
defined in §
261.2, and exhibits one or
more characteristics identified in part
261 subpart C, or is listed in part 261
subpart D. A pharmaceutical is not a
solid waste, as defined in §
261.2, and
therefore not a hazardous waste
pharmaceutical, if it is legitimately
used/reused (e.g., lawfully donated for
its intended purpose) or reclaimed. An
OTC pharmaceutical, dietary
supplement, or homeopathic drug is not
a solid waste, as defined in §
261.2, and
therefore not a hazardous waste
pharmaceutical, if it has a reasonable
expectation of being legitimately used/
reused (e.g., lawfully redistributed for
its intended purpose) or reclaimed.
The Agency is including in the final
definition of ''hazardous waste
pharmaceutical'' that a pharmaceutical
is not a solid waste, as defined in
§
261.2, and therefore not a hazardous
waste pharmaceutical if it is lawfully
donated. The Agency included this
language to clarify that pharmaceuticals
are not solid waste if they are donated
for use (see section IX.B for more
discussion).
The Agency is defining the term
''hazardous waste pharmaceutical'' in
order to clarify its intent that only
pharmaceuticals (as defined in this final
rule) that are hazardous waste when
disposed or discarded need to be
managed under the final subpart P
management standards. For example,
warfarin (brand name Coumadin) is a
listed hazardous waste and when
discarded meets the definition of
hazardous waste pharmaceutical. The
Agency notes that hazardous waste
pharmaceuticals are hazardous wastes;
more specifically, they are a subset of
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The proposed rule used the term
''pharmaceutical reverse distributor'' but the final
rule uses the term ''reverse distributor.'' To avoid
confusion, we use the term ''reverse distributor'' in
this preamble, even when discussing the proposed
rulemaking.
155
As noted in the definition of ''potentially
creditable hazardous waste pharmaceutical,''
manufacturers provide credit for those
pharmaceuticals that are less than one year past the
expiration date.
156
Through the return of pharmaceuticals by a
pharmacy for manufacturer credit, manufacturers
are able to maintain control of the pharmaceutical
up to the point of its disposal, thereby, decreasing
the risk of diversion of the pharmaceutical.
hazardous waste. The term hazardous
waste is defined in §
260.10 as ''a
hazardous waste as defined in §
261.3.''
Therefore, even though we do not
reference §
261.3 in the definition of
hazardous waste pharmaceutical, a
hazardous waste pharmaceutical is also
hazardous waste as defined in §
261.3.
This is relevant to the OSHA Hazardous
Waste Operations and Emergency
Response standard (29 CFR 1910.120),
which apply to hazardous wastes, as
defined by §
261.3. This final rule does
not impact the applicability of the
OSHA Hazardous Waste Operations and
Emergency Response standards.
Multiple commenters suggested that
the proposed definition of ''hazardous
waste pharmaceutical'' was too narrow
because the P- and U-hazardous waste
lists have not been updated even though
new pharmaceuticals have been
developed. Although we solicited ideas
from commenters for possible methods
or approaches for regulating additional
pharmaceuticals as hazardous waste,
any action taken to address the
comments we received in response to
this request would have to be a separate
action taken by the Agency in the future
and is not part of this final rulemaking.
Therefore, these comments are
considered to be out of the scope of this
final action and we do not plan to
address them at this time. That said, we
do anticipate that because subpart P
lowers regulatory barriers to over-
managing non-hazardous waste
pharmaceuticals, some healthcare
facilities will choose to over-manage
non-hazardous waste pharmaceuticals
as hazardous waste pharmaceuticals
even if they do not meet a current listing
or exhibit a hazardous waste
characteristic.
C. Definition of Reverse Distributor
154
1. Summary of Proposal
EPA proposed to define reverse
distributor as any person that receives
and accumulates potentially creditable
hazardous waste pharmaceuticals for
the purpose of facilitating or verifying
manufacturer credit. EPA proposed that
any person, including forward
distributors and pharmaceutical
manufacturers, that processes
pharmaceuticals for the facilitation or
verification of manufacturer credit
would be considered a reverse
distributor. Pharmaceutical
manufacturers often offer credit to
healthcare facilities for unused and/or
expired pharmaceuticals.
155
Manufacturers issue credit for a variety
of reasons: it can be a marketing
incentive tool, it helps protect against
illicit diversion
156
or improper
disposal, and it allows manufacturers to
collect data on the returned items,
which then can be used to help plan for
future pharmaceutical production.
Reverse distributors contract with both
manufacturers and healthcare facilities
to act as an intermediary to facilitate the
crediting process.
EPA proposed new standards for
shipping potentially creditable
hazardous waste pharmaceuticals to
reverse distributors and management
standards of potentially creditable
hazardous waste pharmaceuticals by
reverse distributors. Thus, EPA
proposed to define ''reverse distributor''
to clearly delineate which types of
facilities were subject to the proposed
rulemaking. The agency solicited public
comment on its proposed definition of
''reverse distributor.'' Specifically, EPA
asked for comment on whether the
definition of ''reverse distributor''
captures the universe of facilities acting
as reverse distributors for
pharmaceuticals.
2. Summary of Comments
Commenters requested that EPA
clarify who would be considered a
reverse distributor and what the
functions of a reverse distributor are.
States and industry, including
manufacturers, wholesalers, and waste
management companies, wanted to
know if any facility that performed
reverse distribution functions would be
encompassed in this definition. Reverse
distributors asked for clarification in
how 3PLs fit into the definition of
reverse distributor and whether all
functions performed by their business
would fall under the definition.
3. Final Rule Provision
Under the final rule, reverse
distributor means any person that
receives and accumulates prescription
pharmaceuticals that are potentially
creditable hazardous waste
pharmaceuticals for the purpose of
facilitating or verifying manufacturer
credit. Any person, including forward
distributors, third-party logistics
providers, and pharmaceutical
manufacturers, that processes
prescription pharmaceuticals for the
facilitation or verification of
manufacturer credit is considered a
reverse distributor.
In response to comments, EPA made
two changes to the definition of ''reverse
distributor'' for the final rule. First, EPA
proposed to use the term
''pharmaceutical reverse distributor''
but the final rule uses the term ''reverse
distributor.'' EPA dropped the word
''pharmaceutical'' from reverse
distributor because the definition of
pharmaceutical is overly broad given
that it refers to both prescription and
nonprescription pharmaceuticals. EPA
received comments from stakeholders
pointing out that in the terminology of
the industry, reverse distributors receive
prescription pharmaceuticals, while
reverse logistics centers receive
nonprescription pharmaceuticals and
other unsold retail items. This
distinction is useful to EPA in making
the same distinction in these regulations
and EPA has adopted it.
The second change EPA made was to
add the word prescription to the
definition to further clarify that the
definition does not include reverse
logistics centers that receive
nonprescription pharmaceuticals or
other unsold retail items that are
evaluated for legitimate use/reuse or
reclamation. EPA's definition of
''reverse distributor'' only includes
prescription hazardous waste
pharmaceuticals that are evaluated for
credit and then disposed. EPA made
this clarification to be consistent with
the policy for the reverse logistics of
nonprescription pharmaceuticals and
other unsold retail items. See section VI
of this preamble for discussion of the
regulations for the reverse distribution
of prescription hazardous waste
pharmaceuticals and the policy for the
reverse logistics of other unsold retail
items, including nonprescription
pharmaceuticals.
EPA incorporated the changes to the
final definition of ''reverse distributor''
in response to the comments
summarized below.
4. Comments and Responses
EPA received comments from states
and industry, including manufacturers,
wholesalers and waste management
companies, asking for clarification on
who would be considered a reverse
distributor. For example, commenters
asked whether wholesalers, forward
distributors and 3PLs meet the
definition of ''reverse distributor'' even
if reverse distribution is only a part of
their business. For example, a facility
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Healthcare Distribution Management
Association has since been renamed Healthcare
Distribution Alliance.
158
See comment #EPA-HQ-RCRA-2007-0932-
0276.
159
See 21 CFR 1300.01. On September 9, 2014,
DEA finalized new definitions for ''reverse
distribute'' and ''reverse distributor.'' Please see 79
FR 53520. The term ''reverse distributor'' is defined
as ''a person registered with the Administration
[DEA] as a reverse distributor.''
160
In order for a reverse distributor to be able to
accept controlled substances, the reverse distributor
must be a DEA registrant. See 21 CFR part 1308 for
a complete list of controlled substances.
might act as a sorting and shipping
facility or a pharmacy might act as a
consolidation center but not evaluate for
manufacturer credit. The definition of
''reverse distributor'' specifically states
that any person, including forward
distributors (e.g., wholesalers), 3PLs, or
pharmaceutical manufacturers, that
processes prescription pharmaceuticals
for the facilitation or verification of
manufacturer credit is considered a
reverse distributor. Any person that is
performing the function of a reverse
distributor, even if it is a small part of
their business, would need to operate
under the reverse distributor standards.
If a facility is not processing any
hazardous waste prescription
pharmaceuticals for facilitating or
verifying manufacturer credit, then it
would not meet the definition of
''reverse distributor.''
The retail industry was especially
concerned with need to differentiate
between reverse distributors and reverse
logistics centers. Reverse logistics
centers that receive nonprescription
pharmaceuticals (such as OTC
pharmaceuticals) would not fall under
this definition. Likewise, wholesale
distributors receiving returns from their
customers would not be considered
reverse distributors. This is because
wholesale distributors do not facilitate
manufacturer credit. Further, according
to comments received from Healthcare
Distribution Management Association,
in 2013, approximately 94% of the
returns to wholesale distributors, were
saleable.
157
158
As saleable products, the
pharmaceuticals returned to wholesale
distributors would remain subject to the
track and trace requirements of the
DSCSA. Reverse logistics centers, which
evaluate nonprescription
pharmaceuticals for legitimate use/reuse
and reclamation do not fit this
definition.
EPA is also finalizing the definitions
for potentially creditable and non-
creditable hazardous waste
pharmaceuticals (in parts D and E of
this section) to differentiate between
reverse distributors' function in
evaluation of credit versus the
traditional TSDF role in waste disposal.
It is the Agency's intent that potentially
creditable hazardous waste
pharmaceuticals can be sent to reverse
distributors for the determination of
credit under subpart P. It is not the
Agency's intent, however, for reverse
distributors to serve in the capacity as
storage facilities or TSDFs for other
hazardous waste.
Multiple state commenters asked EPA
to clarify what is meant by ''facilitate.''
The facilitation of credit encompasses
the role that reverse distributors serve
between healthcare facilities and
manufacturers. A reverse distributor
receives potentially creditable
hazardous waste pharmaceuticals for
evaluation of manufacturer credit. Once
the evaluation is complete and it is
determined that credit can be given,
reverse distributors will issue the
manufacturer credit on behalf of the
manufacturer to the healthcare facility.
Reverse distributors wanted to add all
the other functions performed by
reverse distributors to the regulatory
definition to more fully define their
role. EPA did not add reverse
distributors' other functions to the
definition of ''reverse distributor'' in the
final rule. While a reverse distributor
may continue to perform other lawful
activities, they are not relevant for the
purpose of defining a reverse distributor
under this final rule. EPA's definition of
reverse distribution focuses on issuing
of manufacturer credit because although
the pharmaceuticals are hazardous
waste, they have value to the healthcare
facility and the reverse distributor.
Since these hazardous waste
pharmaceuticals have value, there is a
greater economic incentive to manage
them with more care than typical
hazardous waste. The final definition
captures the handling of prescription
hazardous waste pharmaceuticals that
fall under RCRA and the rest of the
functions can be regulated, as needed,
under local, state and other federal
regulations.
The waste management industry
requested clarification on the
intersection of DEA reverse distributors
and RCRA reverse distributors and how
a reverse distributor that receives a DEA
controlled substance as a waste would
determine if they are also subject to
subpart P. A hazardous waste
pharmaceutical that is also a DEA
controlled substance is not subject to
subpart P, provided they meet the terms
of the conditional exemption in
§
266.506. The conditional exemption
for DEA controlled substances that are
also RCRA hazardous waste is covered
in section XIV of the preamble.
The Agency also wants to clarify the
difference between what is defined as a
reverse distributor under this final rule
and how DEA regulations define
''reverse distribute.'' The recently
amended DEA regulatory definition of
''reverse distribute'' is to ''acquire
controlled substances from another
registrant or law enforcement for the
purposes of: (1) Return to the registered
manufacturer or another registrant
authorized by the manufacturer to
accept returns on the manufacturer's
behalf; or (2) Destruction.''
159
Under DEA's definition, a reverse
distributor does not necessarily process
pharmaceuticals for the purpose of
determining manufacturer credit: Often
a reverse distributor's main function
under DEA's definition is to destroy the
controlled substances. Under EPA's
definition, however, a reverse
distributor is defined as a facility that
accepts potentially creditable
pharmaceuticals for the purposes of
evaluating manufacturer credit. These
potentially creditable hazardous waste
pharmaceuticals may or may not be
identified as controlled substances by
DEA.
160
Therefore, a DEA-registered
reverse distributor may or may not meet
EPA's definition of a reverse distributor
and vice versa. For example, a reverse
distributor that accepts DEA controlled
substances that are also hazardous waste
pharmaceuticals for the purpose of
destruction (e.g., incineration) would be
regulated as a DEA-registered reverse
distributor and as a RCRA TSDF (or
other regulated incinerator, depending
on what other wastes it combusts), but
not as a reverse distributor under part
266 subpart P. Conversely, a reverse
distributor that processes
pharmaceuticals for manufacturer
credit, but is not a DEA registrant and
therefore, cannot accept controlled
substances, would meet the subpart P
reverse distributor definition, but not
DEA's reverse distributor definition.
However, EPA has heard from
stakeholders that most, if not all,
entities that facilitate manufacturer
credit are also DEA-registered reverse
distributors. Therefore, such reverse
distributors would meet both EPA's
definition of reverse distributor and the
DEA's definition of reverse distributor.
Lastly, EPA's definition for reverse
distribution does not alter or supersede
the requirements of the Controlled
Substances Act and DEA regulations.
In addition, the DOT's Pipeline and
Hazardous Materials Safety
Administration has defined the closely
related term, ''reverse logistics,'' in a
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79 FR 46748; August 11, 2014. The Pipeline
and Hazardous Material Safety Administration's
definition of reverse logistics ''is the process of
moving goods from their final destination for the
purpose of capturing value, recall, replacement,
proper disposal, or similar reason.''
162
See email correspondence from Nicole
Wilkinson of CVS dated February 21, 2018 and
Erica Burwell of Inmar dated February 22, 2018,
both in the docket for this rulemaking EPA-HQ-
RCRA-2007-0932.
recent rulemaking.
161
EPA coordinated
with the Pipeline and Hazardous
Materials Safety Administration to
ensure that our rules are compatible,
even if the definitions differ. It is
important to note that their final rule
does not supersede EPA's RCRA
Subtitle C regulations for solid or
hazardous waste determinations or
hazardous waste management.
D. Definition of Potentially Creditable
Hazardous Waste Pharmaceutical
1. Summary of Proposal
In order to distinguish hazardous
waste pharmaceuticals that are sent by
a healthcare facility to RCRA TSDFs
from those hazardous waste
pharmaceuticals that are sent by a
healthcare facility to a reverse
distributor for a determination or
verification of manufacturer credit, the
Agency proposed a definition for
''potentially creditable hazardous waste
pharmaceutical.''
EPA proposed to define ''potentially
creditable hazardous waste
pharmaceutical'' to mean a hazardous
waste pharmaceutical that has the
potential to receive manufacturer credit
and is
(1) unused or un-administered; and
(2) unexpired or less than one year
past expiration date.
The proposed term did not include
evaluated hazardous waste
pharmaceuticals, residues of
pharmaceuticals remaining in
containers, contaminated personal
protective equipment, and clean-up
material from the spills of
pharmaceuticals. These pharmaceuticals
are typically unopened and in their
original packaging and include both
generic and name brand
pharmaceuticals.
Whether a pharmaceutical is eligible
for manufacturer credit is determined
solely by the manufacturer's return
policy. Based on comments received for
the 2008 Universal Waste proposed
rulemaking and through discussions
with various stakeholders, the Agency
understands that the return policies of
manufacturers change regularly. As a
result, healthcare facilities are not
always aware if a particular
pharmaceutical will be creditable at the
time that it is pulled from the shelves.
However, the Agency also understands
that there are instances where it is well
known that a pharmaceutical will not be
creditable. Examples of these instances
include the following: If the
pharmaceutical has been removed from
the original container and repackaged
for dispensing purposes; if an attempt
was made to administer a
pharmaceutical, but the patient refused
to take it; if the hazardous waste
pharmaceutical was generated during
patient care; if the pharmacy receives a
return of a dispensed pharmaceutical for
which they had already received
compensation by a third-party payer; or
if the pharmaceutical is more than one
year past its expiration date. In these
instances, as well as others, the
healthcare facility knows that it will not
receive manufacturer credit. It is the
Agency's intent for the proposed
definition of ''potentially creditable
hazardous waste pharmaceutical'' to
allow the return of hazardous waste
pharmaceuticals to reverse distributors
for the determination of credit. It is not
the Agency's intent, however, for
reverse distributors to serve in the
capacity as TSDFs when it is well
known that the manufacturer will not
give credit for those hazardous waste
pharmaceuticals.
Also, based on communication with
stakeholders and the public comments
received on the 2008 Universal
Pharmaceutical Waste proposal, EPA
understands that pharmaceutical
manufacturers' policies often allow for
credit to be issued on the return of
''partials.'' ''Partials'' is a term used in
the industry to refer to opened
containers that have had some contents
removed. Under the proposed
definition, the Agency considered
partials to be potentially creditable
hazardous waste pharmaceuticals.
2. Summary of Comments
States, manufacturers and waste
management companies commented
that word changes to this definition
would clarify which hazardous waste
pharmaceuticals could or could not be
returned to reverse distributors.
Manufacturers, some states and
healthcare facilities argued that all
pharmaceuticals should go to reverse
distributors to relieve the burden on
healthcare facilities to make these
individual determinations. Pharmacists
and reverse distributors wanted further
clarification on what distinguishes a
potentially creditable hazardous waste
pharmaceutical and how it relates to
credit.
3. Final Rule Provision
In response to comments, EPA has
made five changes to the definition of
''potentially creditable hazardous waste
pharmaceutical'' from the proposal.
First, the final definition specifically
includes prescription pharmaceuticals
only. Second, we added the phrase
''reasonable expectation'' to clarify that
the healthcare facility does not have to
definitively know whether something
will receive manufacturer credit but
rather indicates that they should have a
reasonable expectation that it will. We
also note that EPA could have proposed
to use the term ''creditable hazardous
waste pharmaceuticals,'' but chose to
use the term ''potentially creditable
hazardous waste pharmaceutical'' to
convey the same concept (i.e., that a
healthcare facility does not have to
definitively know whether a specific
item will receive manufacturer credit.)
Third, we replaced ''unadministered''
with the term ''undispensed'' to make
clear that it is not just that a patient
refused to take a prescription
pharmaceutical, but rather that it was
never dispensed to a patient at all.
Fourth, we removed the word ''unused''
from the definition since the use of this
term could introduce some confusion
given that ''partials'' can get
manufacturer credit. Fifth, we specified
that the pharmaceuticals be in the
''original manufacturer's packaging''
since repackaged prescription
pharmaceuticals are not typically
eligible for credit.
162
For the final rule, a potentially
creditable hazardous waste
pharmaceutical means a prescription
hazardous waste pharmaceutical that
has a reasonable expectation to receive
manufacturer credit and is (1) in
original manufacturer's packaging
(except pharmaceuticals that were
subject to recall); (2) undispensed; and
(3) unexpired or less than one year past
expiration date. The term does not
include evaluated hazardous waste
pharmaceuticals or nonprescription
pharmaceuticals including, but not
limited to, OTC drugs, homeopathic
drugs, and dietary supplements.
4. Comments and Responses
a. Definitional Wording. EPA received
many comments from states and
industry on revising the definition to
clarify which hazardous waste
pharmaceuticals could and could not be
returned to reverse distributors. States
especially stressed that ''potentially
creditable'' should be changed to
''reasonable expectation of credit'' or
that EPA should define potentially
creditable hazardous waste
pharmaceuticals as those that are
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accepted by reverse distributors for
evaluation, as compared to those that
are not. Manufacturers and states asked
us to clarify whether we mean
''unadministered'' or ''undispensed'' or
whether the term ''unopened'' should be
added to the definition. The waste
management industry had some concern
that adding expiration dates to the
definition might prevent potentially
creditable hazardous waste
pharmaceuticals from being returned to
the reverse distributor.
In the final definition of potentially
creditable hazardous waste
pharmaceuticals, EPA has added some
new phrases such as ''reasonable
expectation of credit'' to the definition
to be clear that not all hazardous waste
pharmaceuticals should be going back to
reverse distributors. We have also
changed words like ''unadministered''
to ''undispensed'' since the expectation
of credit ends once a pharmaceutical
has been dispensed to a patient
regardless of whether the patient takes
the pharmaceutical and deleted
''unused'' since that could imply it has
been dispensed but not used and/or that
it was never opened.
We are specifically not adding the
word ''unopened'' to the definition as
some commenters had suggested, since
it is EPA's understanding that ''partials''
can be given credit under certain
circumstances and some
pharmaceuticals may be repackaged.
Although the definition does not
include the word ''intact'' when
describing original manufacturer's
packaging, the definition of ''potentially
creditable hazardous waste
pharmaceutical'' does not include
anything that is leaking or damaged.
Some commenters also argued that
EPA was limiting manufacturers from
changing policies by defining
potentially creditable hazardous waste
pharmaceuticals and giving examples of
what those are. EPA recognizes that
special circumstances may arise where
a prescription hazardous waste
pharmaceutical may be given credit but
not fit squarely within this definition.
We have added an example of this in
our definition by noting that a recalled
pharmaceutical may be given credit
although it is not in original packaging.
This definition is meant to give
examples of what is commonly done
and to aid healthcare facilities in being
able to more easily identify a potentially
creditable from a non-creditable
hazardous waste pharmaceutical. It is
not intended to prevent a manufacturer
from changing its credit policies.
b. Evaluation of Hazardous Waste
Pharmaceuticals and Credit. In their
comments regarding potentially
creditable hazardous waste
pharmaceuticals received by reverse
distributors, manufacturers and reverse
distributors expressed concern about the
burden being added to healthcare
facilities by not allowing them to send
all the hazardous waste pharmaceuticals
together and putting the onus on them
to determine if something is
''potentially creditable''. Healthcare
facilities were concerned that credit
policies are frequently updated by
manufacturers and that a healthcare
facility would not know if credit would
be issued for any given pharmaceutical
or not.
Commenters also addressed the
question of a bright line as to what is
and what is not potentially creditable
hazardous waste pharmaceuticals.
Commenters asked whether generics
were considered ''potentially
creditable.'' The waste management
industry commenters asked how many
times credit must be rejected before a
type of pharmaceutical is no longer
considered potentially creditable.
It is the Agency's intent in our
definition of ''potentially creditable
hazardous waste pharmaceutical'' to
allow the return of hazardous waste
pharmaceuticals to reverse distributors
for the determination of manufacturer
credit. It is not the Agency's intent,
however, for reverse distributors to
serve in the capacity as TSDFs when it
is well known that the manufacturer
will not give credit for certain
hazardous waste pharmaceuticals.
EPA recognizes that in some cases a
healthcare facility may not know if the
hazardous waste pharmaceuticals will
be given credit. We do not want to deter
healthcare facilities from sending their
hazardous waste pharmaceuticals to a
reverse distributor if there is a
reasonable expectation of credit.
Whether or not credit is actually given
is not a defining factor and it is not
within EPA's expertise to know how
many times a potentially creditable
hazardous waste pharmaceutical needs
to be rejected before it is considered
''non-creditable.'' Each pharmaceutical
is different and is or is not creditable for
various reasons as dictated by the
manufacturer. EPA has learned since the
proposal that generic prescription drugs
can have a reasonable expectation of
receiving manufacturer credit. EPA also
agrees with commenters that ''partials''
can be given credit.
EPA's intent is to prevent hazardous
waste pharmaceuticals that are clearly
ineligible for credit and are ready for
disposal, due to their condition,
previous use with a patient, or other
reason, from being sent to the reverse
distributor. Hazardous waste
pharmaceuticals that are in original
packaging and have not been dispensed
to a patient would fit under this
definition of ''potentially creditable
hazardous waste pharmaceutical.''
E. Definition of Non-Creditable
Hazardous Waste Pharmaceutical
1. Summary of Proposal
In order to distinguish hazardous
waste pharmaceuticals that have the
potential for credit from those that have
no expectation of receiving credit, the
Agency proposed to define the term
''non-creditable hazardous waste
pharmaceutical.'' The proposed
definition of a ''non-creditable
hazardous waste pharmaceutical'' is a
hazardous waste pharmaceutical that is
not expected to be eligible for
manufacturer credit. Examples include,
but are not limited to pharmaceuticals
that have been removed from the
original container and repackaged for
dispensing purposes; a pharmaceutical
refused by a patient after an attempt to
administer it; hazardous waste
pharmaceuticals generated during
patient care; dispensed pharmaceuticals
returned to a pharmacy after the
pharmacy had already received
compensation by a third-party payer
(e.g., health insurance company); or
pharmaceuticals that are more than one
year past their expiration dates. Non-
creditable hazardous waste
pharmaceuticals are typically opened
and not in their original packaging and
have been dispensed (though not
administered) to a patient. These
conditions of the non-creditable
pharmaceutical are what makes them
not creditable rather than the
manufacturer's policy on the specific
type of pharmaceutical.
2. Summary of Comments
Commenters expressed a variety of
opinions on EPA's proposed definition
of ''non-creditable hazardous waste
pharmaceutical.'' Some states,
manufacturers and the waste
management industry stated that they
were satisfied with the proposed
definition of ''non-creditable hazardous
waste pharmaceutical.'' Wholesalers
argued that the definition should be
struck and the regulations should allow
all intact hazardous waste
pharmaceuticals to go back to a reverse
distributor. Pharmacists, some states,
and the retail industry argued that EPA
should define ''non-creditable
hazardous waste pharmaceuticals'' as
those hazardous waste pharmaceuticals
that are not accepted by reverse
distributors for manufacturer credit.
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3. Final Rule Provision
For the final rule, EPA made three
major changes to the definition of ''non-
creditable hazardous waste
pharmaceutical'' to address comments.
First, EPA has added the word
''prescription'' to the first portion of the
definition to be consistent with the use
of terminology in the final rule that
reverse distribution is the reverse flow
of prescription hazardous waste
pharmaceuticals. Second, the Agency
has added new language to the
definition to reflect the fact that
nonprescription hazardous waste
pharmaceuticals can also be considered
non-creditable hazardous waste
pharmaceuticals that must be managed
under the healthcare facility standards
in §
266.502 when they do not have a
reasonable expectation to be
legitimately used/reused or reclaimed.
For purposes of this definition, the
determination is being made that at the
healthcare facility, prescriptions that
have already been dispensed to a
patient, and free samples given to
healthcare facilities do not have a
reasonable expectation of receiving
manufacturers credit. Third, EPA has
also added examples of non-creditable
hazardous waste pharmaceuticals.
Under the final rule, non-creditable
hazardous waste pharmaceutical means
a prescription hazardous waste
pharmaceutical that does not have a
reasonable expectation to be eligible for
manufacturer credit or a
nonprescription hazardous waste
pharmaceutical that does not have a
reasonable expectation to be
legitimately used/reused or reclaimed.
This includes but is not limited to,
investigational drugs, free samples of
pharmaceuticals received by healthcare
facilities, residues of pharmaceuticals
remaining in empty containers,
contaminated personal protective
equipment, floor sweepings, and clean-
up material from the spills of
pharmaceuticals.
While not specifically laid out in the
definition, other examples of non-
creditable hazardous waste
pharmaceuticals can be pharmaceuticals
that have been removed from the
original container and repackaged for
dispensing purposes; pharmaceuticals
in their original packaging when the
packaging is leaking or otherwise
damaged; a pharmaceutical refused by a
patient after an attempt was made to
administer it; pharmaceuticals
generated during patient care; dispensed
pharmaceuticals returned to a pharmacy
after the pharmacy already received
compensation by a third-party payer
(e.g., health insurance company); or
pharmaceuticals at are more than one
year past their expiration date.
4. Comments and Responses
Wholesalers and some reverse
distributors recommended that we do
not differentiate between potentially
creditable and non-creditable hazardous
waste pharmaceuticals and allow all
hazardous waste pharmaceuticals that
are intact and in original packaging to
go to the reverse distributors. EPA
disagrees with the commenters. EPA
proposed this differentiation between
potentially creditable and non-
creditable hazardous waste
pharmaceuticals to distinguish between
a traditional TSDF and the function
served by a reverse distributor. A
reverse distributor should not act as a
hazardous waste disposal facility for
healthcare facilities. It is serving as the
manufacturer's agent for determination
of credit. If a reverse distributor is not
determining credit, EPA views it as
managing hazardous waste
pharmaceuticals that do not have
monetary value and thus would be
subject to TSDF regulations. If a reverse
distributor begins to routinely receive
non-creditable hazardous waste
pharmaceuticals, then it is serving as a
TSDF. EPA has made this differentiation
to correctly represent the reverse
distributor role as a manufacturer's
agent for facilitating credit and not like
a more traditional hazardous waste
management facility.
Pharmacists, the retail industry and
some states recommended that we
define non-creditable hazardous waste
pharmaceuticals as those hazardous
waste pharmaceuticals that do not
receive credit. There are some situations
in which pharmaceuticals are well
known to not be eligible for credit, such
as leaky containers, samples or when
pharmaceuticals were already dispensed
to patients. The Agency did not finalize
the commenters' recommendation,
however, because it could potentially
lead to situations where a healthcare
facility sends a hazardous waste
pharmaceutical to a reverse distributor
in good faith that manufacturer credit is
forthcoming, but credit is not issued. If
EPA accepted this recommendation, the
reverse distributor could be determined
to unlawfully be in possession of non-
creditable hazardous waste
pharmaceuticals. For this reason, the
Agency added into the definition that
non-creditable hazardous waste
pharmaceuticals are prescription
pharmaceuticals that do not have a
reasonable expectation of receiving
manufacture credit, or a nonprescription
hazardous waste pharmaceutical that
does not have a reasonable expectation
to be legitimately used/reused or
reclaimed. It should be clear to
healthcare personnel that leaking
containers, for example, are not eligible
for credit and should be sent to a
designated facility for disposal (e.g., a
TSDF). However, it is often not clear to
the healthcare facility personnel making
the determination which hazardous
waste pharmaceuticals will receive
manufacturer credit if they were not
dispensed and/or are in their original
packaging (i.e., potentially creditable).
The Agency does find it reasonable that
healthcare personnel may not know if a
manufacturer credit policy for a
particular pharmaceutical has changed.
Because it is not always clear that all
hazardous waste pharmaceuticals will
be eligible for credit due to frequent
changes in manufacturers' policies, it is
inappropriate to create a bright line in
the definition solely based on whether
the hazardous waste pharmaceutical
would or would not receive
manufacturer credit. Instead, this final
definition takes into account this
uncertainty and the difficulty it poses
for healthcare facilities and allows for
instances where a potentially creditable
hazardous waste pharmaceutical can be
correctly sent to a reverse distributor
under the subpart P regulations despite
not actually receiving manufacturer
credit.
F. Definition of Evaluated Hazardous
Waste Pharmaceutical
1. Summary of Proposal
EPA proposed a definition for
evaluated hazardous waste
pharmaceuticals. After potentially
creditable hazardous waste
pharmaceuticals arrive at a reverse
distributor, they are evaluated by the
reverse distributor to determine whether
they are eligible for manufacturer credit
or whether they need to be transferred
to another reverse distributor for
additional verification of manufacturer
credit. Hazardous waste
pharmaceuticals that need to be
transferred to another reverse distributor
for additional verification of
manufacturer credit will continue to be
considered potentially creditable
hazardous waste pharmaceuticals. EPA
proposed that hazardous waste
pharmaceuticals for which
manufacturer credit has been issued
(and no further verification of credit is
required), as well as those that do not
receive credit, be referred to as
''evaluated hazardous waste
pharmaceuticals.''
EPA proposed to define an ''evaluated
hazardous waste pharmaceutical'' as a
hazardous waste pharmaceutical that
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was a potentially creditable hazardous
waste pharmaceutical but has been
evaluated by a reverse distributor to
establish whether it is eligible for
manufacturer credit and will not be sent
to another reverse distributor for further
evaluation or verification.
It is important to define this term
since the proposed management and
shipping standards for potentially
creditable hazardous waste
pharmaceuticals differ from the
proposed management and shipping
standards for evaluated hazardous waste
pharmaceuticals and the regulations
must therefore distinguish between
them. For a discussion of the proposed
shipping and management standards for
potentially creditable hazardous waste
pharmaceuticals, see section XVI.D. and
for a discussion of the proposed
shipping and management standards for
evaluated hazardous waste
pharmaceuticals, see section XVI.B.
2. Summary of Comments
There were few comments pertaining
to this definition. One state sought
clarification on whether under this
definition, an evaluated pharmaceutical
could be sent on to another reverse
distributor. Pharmacists wanted further
clarification that evaluated hazardous
waste pharmaceuticals are not eligible
for credit.
3. Final Rule Provision
For the final rule, EPA made two
changes to the definition of ''evaluated
hazardous waste pharmaceuticals'': (1)
Adding the word ''prescription'' to be
consistent with our decision to
distinguish between reverse distribution
and reverse logistics and (2) focusing
the definition on the evaluation process
and does not rely as heavily on
manufacturer credit.
EPA is finalizing that ''evaluated
hazardous waste pharmaceutical''
means a prescription hazardous waste
pharmaceutical that has been evaluated
by a reverse distributor in accordance
with §
266.510(a)(3) and will not be sent
to another reverse distributor for further
evaluation or verification of
manufacturer credit.
Under the definition of evaluated
hazardous waste pharmaceutical, if
credit has been determined and no other
verification is needed, then the waste
would be considered evaluated. If the
prescription hazardous waste
pharmaceutical needs further evaluation
for credit, it can be sent on to another
reverse distributor for that
determination. It will not be considered
evaluated until the credit is verified.
The Agency notes that an evaluated
pharmaceutical still at the reverse
distributor is not precluded from ever
being awarded manufacturer credit. A
manufacturer may change a credit
policy while an evaluated
pharmaceutical is being accumulated at
a reverse distributor. However, as an
evaluated pharmaceutical, it is no
longer managed as a potentially
creditable pharmaceutical at the reverse
distributor, then it must be managed as
an evaluated hazardous waste
pharmaceutical even if credit is
awarded after the initial evaluation.
Please refer to section XVII.C of this
preamble for a detailed discussion of the
reverse distributor standards.
G. Definition of Household Waste
Pharmaceutical
1. Summary of Proposal
EPA proposed to define the term
''household waste pharmaceutical'' as a
solid waste, as defined in §
261.2, that
also meets the definition of
pharmaceutical, but is not a hazardous
waste because it is exempt from RCRA
Subtitle C regulation by the household
waste exclusion in §
261.4(b)(1).
We proposed this term to distinguish
this type of waste pharmaceutical from
the hazardous waste pharmaceuticals
that are proposed to be regulated under
this new subpart.
2. Summary of Comments
Commenters generally agreed with
EPA's definition of ''household waste
pharmaceutical'' as proposed but were
concerned with applicability of this
definition and where the household
waste exclusion can be used. For
example, one commenter asked if it
extended to schools. A few commenters
wanted to know if this applied to all
DEA take back programs and requested
that the words ''including those
generated by DEA regulations'' be
added. Lastly, commenters asked us to
clarify the significance of the household
waste pharmaceutical definition with
respect to long-term care facilities
(LTCFs).
3. Final Rule Provisions
EPA is finalizing the definition of
''household waste pharmaceutical'' as
proposed with one minor change. EPA
changed the word ''exempt'' to
''excluded'' to be consistent with the
title of §
261.4(b). In the final rule,
''household waste pharmaceutical''
means a pharmaceutical that is a solid
waste, as defined in §
261.2, but is
excluded from being a hazardous waste
under §
261.4(b)(1).
4. Comments and Responses
In response to some of the
commenters' concerns, EPA is defining
the term ''household waste
pharmaceutical'' as a matter of
convenience in crafting the regulatory
language as well as the preamble. By
defining the term, we do not alter the
criteria we have consistently relied on
for determining whether a waste is
considered a household hazardous
waste. The two criteria that must be met
to be a household hazardous waste are
(1) the waste must be generated by
individuals on the premise of a
temporary or permanent residence and
(2) the waste stream must be composed
primarily of materials found in wastes
generated by consumers in their homes.
Section 261.4(b)(1) defines household to
include single and multiple residences,
hotels and motels, bunkhouses, ranger
stations, crew quarters, campgrounds,
picnic grounds and day-use recreation
areas. This exclusion does not include
schools. Schools generate hazardous
waste from various sources throughout
the school grounds such as chemicals
from labs, cleaning supplies and
hazardous waste pharmaceuticals from
medical clinics. These wastes are not
being generated at a temporary or
permanent residence and are not the
types of wastes that would ordinarily be
generated by a consumer at their home.
Pharmaceuticals generated at schools
would not be considered household
waste pharmaceuticals. However,
hazardous waste pharmaceuticals
generated at dormitories at schools
would be considered household waste
pharmaceuticals and thus excluded,
because the dormitories are residences.
Some types of healthcare facilities
could be considered households. This
final rule defines the term LTCF in
§
266.500. LTCF means a licensed entity
that provides assistance with activities
of daily living, including managing and
administering pharmaceuticals to one or
more individuals at the facility. This
definition includes, but is not limited
to, hospice facilities, nursing facilities,
skilled nursing facilities, and the
nursing and skilled nursing care
portions of continuing care retirement
communities. Not included within the
scope of this definition are group
homes, independent living
communities, assisted living facilities,
and the independent and assisted living
portions of continuing care retirement
communities. The types of healthcare
facilities listed at the end of this
definition that are not considered to be
LTCFs are not subject to subpart P
requirements and hazardous waste
pharmaceuticals generated there
continue to be excluded from RCRA as
household hazardous wastes. For a more
thorough discussion of the applicability
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163
45 CFR part 160 http://aspe.hhs.gov/
admnsimp/final/pvctxt01.htm.
164
For more information on the disposal process,
please see: Ruhoy, I.S. and Daughton, C.G. ''Types
and Quantities of Leftover Drugs Entering the
Environment via Disposal to Sewage-Revealed by
Coroner Records,'' Sci. Total Environ., 2007, 388(1-
3):137-148. https://cfpub.epa.gov/si/si_public_
record_report.cfm?dirEntryID=168384.
of the household hazardous waste
exclusion at LTCFs, see section VIII.K of
this preamble.
While DEA controlled substances can
sometimes be household waste
pharmaceuticals, once these wastes are
collected at a take back event or by law
enforcement, DEA regulations require
that any proper disposal must meet the
DEA non-retrievable standards of
destruction. Furthermore, this EPA rule
finalizes specific requirements for the
destruction of collected household
waste pharmaceuticals, see section XIV
of this preamble for details. Therefore,
it could have been confusing to add
''including waste under DEA
regulations'' to the definition of
household waste pharmaceutical.
H. Definition of Non-Hazardous Waste
Pharmaceutical
1. Summary of Proposal
EPA proposed to define the term
''non-hazardous waste pharmaceutical.''
While hazardous waste pharmaceuticals
are regulated under this new subpart,
non-hazardous waste pharmaceuticals
are not regulated under RCRA Subtitle
C, including this new subpart. The
Agency proposed this definition since
we believed it was important to clearly
delineate what is and is not regulated
under this new subpart.
The Agency proposed to define the
term ''non-hazardous waste
pharmaceutical'' as a pharmaceutical
that is a solid waste, as defined in
§
261.2, but is not listed in 40 CFR part
261 subpart D, and does not exhibit a
characteristic identified in 40 CFR part
261 subpart C. The characteristics of
hazardous waste are ignitability,
corrosivity, reactivity, and toxicity.
2. Summary of Comments
Most commenters agreed with the
definition of ''non-hazardous waste
pharmaceutical'' as proposed. There
were some comments concerning
commingling of hazardous and non-
hazardous waste. These comments are
addressed in detail in section X.C. and
XI.A. of this preamble.
3. Final Rule Provision
The Agency is finalizing the
definition of ''non-hazardous waste
pharmaceutical'' as proposed, with no
changes. In this rule, a ''non-hazardous
waste pharmaceutical'' is a
pharmaceutical that is a solid waste, as
defined in §
261.2, but is not listed in
40 CFR part 261 subpart D, and does not
exhibit a characteristic identified in 40
CFR part 261 subpart C.
I. Definition of Non-Pharmaceutical
Hazardous Waste
1. Summary of Proposal
Like the previous definition, we
proposed to define non-pharmaceutical
hazardous waste to help delineate what
is and what is not regulated under this
new subpart. We proposed to define the
term ''non-pharmaceutical hazardous
waste'' as a solid waste, as defined in
§
261.2, that is listed in 40 CFR part 261
subpart D, or exhibits one or more
characteristics identified in 40 CFR part
261 subpart C, but is not a
pharmaceutical as defined in this
section.
The proposed definition was needed
because the management of non-
pharmaceutical hazardous wastes is not
regulated under subpart P; rather,
generators of non-pharmaceutical
hazardous wastes, including healthcare
facilities and reverse distributors,
remain subject to part 262 and other
applicable Subtitle C hazardous waste
regulations for the management of those
hazardous wastes.
2. Summary of Comments
There were only a few comments on
the proposed definition of ''non-
pharmaceutical hazardous waste.''
Commenters generally agreed with the
definition, but two commenters wanted
EPA to clarify how to classify a waste
with an ingredient that is used in both
pharmaceutical and non-pharmaceutical
items.
3. Final Rule Provisions
EPA is finalizing the definition of
non-pharmaceutical hazardous waste, as
proposed, with no changes. In this final
rule, ''non-pharmaceutical hazardous
waste'' is a solid waste, as defined in
§
261.2, that is listed in 40 CFR part 261
subpart D, or exhibits one or more
characteristics identified in 40 CFR part
261 subpart C, but is not a
pharmaceutical as defined in §
266.500.
4. Comments and Responses
Multiple commenters asked EPA to
clarify how a hazardous waste should be
managed when it is used as an
ingredient in both pharmaceuticals and
non-pharmaceutical, e.g., isopropyl
alcohol, which can be used both as an
antiseptic and a degreaser. Please see
the definition in section VIII.A. for
discussion about what meets the
definition of pharmaceutical, including
how to apply the definition in this type
of scenario. Any hazardous waste not
meeting the definition of
pharmaceutical is considered a non-
pharmaceutical hazardous waste and
should be managed under all applicable
RCRA standards.
J. Definition of Healthcare Facility
1. Summary of Proposal
EPA proposed to define ''healthcare
facility'' as any person that provides
preventative, diagnostic, therapeutic,
rehabilitative, maintenance or palliative
care, and counseling, service,
assessment or procedure with respect to
the physical or mental condition, or
functional status, of a human or animal
or that affects the structure or function
of the human or animal body; or sells
or dispenses OTC or prescription
pharmaceuticals. The proposed
definition was adapted from the
definition of ''health care'' that the
Department of Health and Human
Services promulgated as a result of the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA) (45
CFR part 160.103).
163
The proposed
definition of ''healthcare facility''
included, but was not limited to,
hospitals, psychiatric hospitals,
ambulatory surgical centers, health
clinics, physicians' offices, optical and
dental providers, chiropractors, LTCFs,
ambulance services, coroners and
medical examiners, pharmacies, long-
term care pharmacies, mail-order
pharmacies, retailers of OTC
medications; and veterinary clinics and
hospitals.
EPA proposed to include coroners
and medical examiners in the definition
of ''healthcare facility'' despite the fact
that the services coroners provide occur
after life. Coroners will often inventory,
and then dispose of, any
pharmaceuticals that may be found at
the scene of a death, and commonly
sewer dispose of pharmaceuticals by
putting them down the drain.
164
In
order to reduce sewer disposal of
pharmaceuticals and provide these
facilities with the same management
options that are available to other
healthcare facilities, EPA included
coroners in the proposed definition of
healthcare facility.
The proposed definition of healthcare
facility did not include pharmaceutical
manufacturers and their representatives,
wholesalers, or any other entity that is
involved in the manufacturing,
processing, or wholesale distribution of
pharmaceuticals. EPA proposed to
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exclude manufacturing facilities from
the definition of healthcare facility
because the Agency did not anticipate
that manufacturing facilities, which
predictably generate a known range of
hazardous wastes, face the same issues
as healthcare facilities.
2. Summary of Comments
EPA requested comment on including
coroners in the definition of ''healthcare
facility.'' EPA received three comments
supporting the inclusion of coroners in
the definition of ''healthcare facility.''
One stakeholder was aware of coroner
facilities that sewer dispose of
pharmaceuticals and argued to include
them in the definition in order to reduce
the sewer disposal of pharmaceuticals.
Two commenters expressed concern
about including coroners in the
definition of ''healthcare facility.'' One
commenter stated that including
coroners in the definition could
discourage coroners from promoting
take-back programs.
EPA also took comment on including
compounding pharmacies in the
definition of ''healthcare facility.'' Three
commenters supported the inclusion of
compounding pharmacies in the
definition. One commenter stated that
compounding pharmacies should be
included because they do not
predictably generate a known range of
hazardous wastes and face problems
similar to that of a healthcare facility.
The most frequent comment the
Agency received on the definition of
''healthcare facility'' was that EPA
should define wholesale distributors
and third-party logistics providers as
healthcare facilities or to create a
separate definition for wholesale
distributors and third-party logistics
providers, but allow them to operate
under the same standards as healthcare
facilities.
3. Final Rule Provisions
EPA is finalizing a definition for
''healthcare facility'' so that it is clear to
whom these final regulations apply.
EPA is finalizing that ''healthcare
facility'' means any person that is
lawfully authorized to (1) provide
preventative, diagnostic, therapeutic,
rehabilitative, maintenance or palliative
care, and counseling, service,
assessment or procedure with respect to
the physical or mental condition, or
functional status, of a human or animal
or that affects the structure or function
of the human or animal body; or (2)
distribute, sell, or dispense
pharmaceuticals, including OTC
pharmaceuticals, dietary supplements,
homeopathic drugs, or prescription
pharmaceuticals. This definition
includes, but is not limited to,
wholesale distributors, third-party
logistics providers that serve as forward
distributors, military medical logistics
facilities, hospitals, psychiatric
hospitals, ambulatory surgical centers,
health clinics, physicians' offices,
optical and dental providers,
chiropractors, LTCFs, ambulance
services, pharmacies, long-term care
pharmacies, mail-order pharmacies,
retailers of pharmaceuticals, and
veterinary clinics and hospitals. This
definition does not include
pharmaceutical manufacturers, reverse
distributors, or reverse logistics centers.
Although EPA uses the term
''person,'' in the definition of healthcare
facility, the definition of healthcare
facility does not necessarily apply to
individual healthcare providers at a site.
As defined in §
260.10, ''person'' means
''an individual, trust, firm, joint stock
company, Federal Agency, corporation
(including a government corporation),
partnership, association, State,
municipality, commission, political
subdivision of a State, or any interstate
body.'' Accordingly, a healthcare facility
can have multiple healthcare providers
or a sole healthcare provider. For
example, an individual healthcare
provider who works at a hospital with
multiple healthcare providers is not
considered a healthcare facility, but the
hospital is considered a healthcare
facility, under the final definition.
Additionally, a doctor's office with a
sole healthcare provider would also be
considered a healthcare facility under
this final rule.
The proposed definition of
''healthcare facility'' did not apply to
pharmaceutical manufacturers'
representatives, wholesale distributors,
third-party logistics providers, or any
other entity that is involved in the
wholesale distribution of prescription or
OTC pharmaceuticals. Commenters
argued that excluding wholesale
distributors and third-party logistics
providers from the definition of
''healthcare facility,'' in combination
with the revised interpretation that the
point of generation for potentially
creditable hazardous waste
pharmaceuticals is at the healthcare
facility, could hinder wholesale
distributors' and third-party logistics
providers' ability to send potentially
creditable pharmaceuticals through
reverse distribution. These commenters
were concerned that if they were not
included in the definition of ''healthcare
facility'' they would be precluded from
using reverse distributors. Commenters
also pointed out that wholesale
distributors and third-party logistics
facilities are likely to generate
hazardous waste pharmaceuticals
unpredictably and that their workers
typically do not have the expertise to
make hazardous waste determinations.
Due to these comments, the Agency
anticipates that wholesale distributors
and third-party logistics facilities face
similar issues as healthcare facilities
and therefore is including them in the
final definition of ''healthcare facility.''
The final definition of ''healthcare
facility'' includes wholesale
distributors, third-party logistics
providers that engage in forward
distribution, and military medical
logistics facilities. Including wholesale
distributors and third-party logistics
facilities in the definition of ''healthcare
facility'' ensures that these facilities can
continue sending potentially creditable
hazardous waste pharmaceuticals
through reverse distribution. EPA
recognizes that wholesale distributors
and third-part logistics providers are not
accustomed to referring to themselves as
healthcare facilities. However, it is
helpful to have a single, umbrella term
when discussing who is subject to this
subpart.
The final definition of ''healthcare
facility'' does not apply to
pharmaceutical manufacturers or any
other entity that is involved in the
manufacturing of OTC or prescription
pharmaceuticals. The purpose for these
sector-based regulations is to address
the various issues that healthcare
facilities and reverse distributors face
when managing hazardous waste
pharmaceuticals. The Agency does not
anticipate that manufacturing facilities,
which predictably generate a known
range of hazardous wastes, face the
same issues as healthcare facilities, and
therefore are excluded from the
definition of ''healthcare facility'' under
this rule.
The final definition of ''healthcare
facility'' includes locations that sell
pharmaceuticals over the internet,
through the mail, or through other
distribution mechanisms. A pharmacy
does not necessarily have to have a
''brick and mortar'' or ''store front''
presence to be considered a healthcare
facility for the purposes of this final
rule. The final definition of a
''healthcare facility'' also applies to
entities that engage in drug
compounding. In general, compounding
is a practice in which a licensed
pharmacist, a licensed physician, or, in
the case of an outsourcing facility, a
person under the supervision of a
licensed pharmacist, combines, mixes,
or alters ingredients of a drug to create
a medication tailored to the needs of an
individual patient. EPA solicited
comment on including compounding
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See November 13, 1984; 49 FR 44978.
166
Memo from Petruska to McNally, February 28,
1995; RCRA Online #11897 that discusses the
distinction about what renovation waste is
household hazardous waste and what is not.
pharmacies in the definition of
healthcare facility and received three
comments supporting and no comments
opposing the inclusion of compounders
in the definition. The final definition of
''healthcare facility'' applies to state-
licensed pharmacies, federal facilities,
and licensed physicians that compound
drugs in accordance with section 503A
of the FD&C Act, and to outsourcing
facilities that compound drugs in
accordance with section 503B of the
FD&C Act.
4. Comments and Responses
The final definition does not include
independently located coroners and
medical examiners. EPA made this
change in response to commenter
concern that including coroners and
medical examiners in the definition
could discourage coroners and medical
examiners from promoting take-back
programs for household
pharmaceuticals. However, coroners
and medical examiners that are co-
located with healthcare facilities, such
as hospitals, will fall under the
definition of ''healthcare facility,''
because they are physically part the
healthcare facility.
K. Definition of Long-Term Care Facility
1. Summary of Proposal
The proposed definition of healthcare
facility specifically included LTCFs as
an example of a type of healthcare
facility. Since the term ''long-term care
facility'' does not have a standardized,
industry definition, EPA proposed to
define the term for purposes of this rule.
We proposed to define a LTCF as a
licensed entity that provides assistance
with activities of daily living, including
managing and administering
pharmaceuticals to one or more
individuals at the facility. This
definition includes, but is not limited
to, assisted living, hospices, nursing
homes, skilled nursing facilities, and the
assisted living and skilled nursing care
portions of continuing care retirement
communities. Not included within the
scope of this definition are group
homes, independent living
communities, and the independent
living portions of continuing care
retirement communities.
The facilities we proposed to include
as LTCFs are licensed care facilities that
are more similar to hospitals than to
standard residences. Although group
homes may be licensed care facilities,
they are typically very small (fewer than
10 beds) and therefore were not
included within the proposed
definition. Similarly, independent
living communities are not licensed care
facilities, but rather are residences made
up of individual units such as
townhomes or apartments and therefore
were not included within the proposed
definition. Finally, we clarified in the
preamble to the proposed rulemaking
that private residences with visiting
nurses would not be considered long-
term care facilities.
By proposing to define a LTCF as a
type of healthcare facility, EPA was
proposing to revise its policy regarding
the regulatory status of hazardous waste
from long-term care facilities. We
proposed that hazardous waste from
LTCFs would no longer be excluded as
household hazardous waste; rather, it
would be regulated as hazardous waste,
subject to the appropriate RCRA Subtitle
C management standards, including the
standards proposed for hazardous waste
pharmaceuticals under part 266 subpart
P. In other words, the proposed revision
to our policy regarding long-term care
facilities pertained to all of the facilities'
hazardous waste, not just the hazardous
waste pharmaceuticals.
The Agency proposed revising its
interpretation with regard to hazardous
wastes generated at LTCFs based on a
reevaluation of how such facilities
operate. Specifically, in order to qualify
for the household hazardous waste
exclusion of §
261.4(b)(1), waste must
meet two criteria: (1) The hazardous
waste must be generated by individuals
on the premises of a household, and (2)
the hazardous waste must be composed
primarily of materials found in the
wastes generated by consumers in their
homes.
165
In the preamble to the
proposed rulemaking, EPA explained
that hazardous waste generated at
LTCFs, even those pharmaceuticals that
are under the control of the patient or
resident, does not meet either criterion
for the household hazardous waste
exemption.
In brief, the explanation provided in
the preamble to the proposed
rulemaking was two-fold. First, a LTCF
is more similar to a hospital than it is
a typical residence and EPA does not
consider a hospital to be a household.
LTCFs are licensed, residential care
settings that offer their residents a wide
range of services, many of which are
centered on administering medications
and providing healthcare by various
professional healthcare providers, such
as medical technicians, nurse's aides,
nurses, and doctors. Other services
provided involve assistance in
performing activities of daily living,
such as bathing and eating. Given that
LTCFs are licensed settings for the care
of their residents and routinely provide
healthcare services, EPA believes that
LTCFs more closely resemble hospitals
than typical residences.
Second, we explained, the hazardous
wastes generated by LTCFs do not meet
the second criteria for the waste to be
considered household hazardous waste.
This is primarily due to the quantity
and breadth of pharmaceutical wastes
that are often generated on the premises
of LTCFs when compared to a typical
residence. This distinction about
volume and breadth of waste is
analogous to the distinction that EPA
has made in the past about contractor or
do-it-yourself waste from households:
Waste from ''routine residential
maintenance'' is exempt as household
hazardous waste, while waste from
''building construction, renovation,
demolition'' is not excluded.
166
2. Summary of Comments
EPA received a number of comments
requesting changes to the proposed
definition of ''LTCF'' that were
instrumental in the final definition in
the rule. We also received a number of
comments related to whether hazardous
waste from LTCFs should be excluded
from RCRA Subtitle C regulations as
household hazardous waste.
3. Final Rule Provisions
Based on comments, we have made
some changes to the proposed definition
of LTCF. The final definition retains the
descriptive portion of the definition, but
the list of types of facilities included as
a LTCF has been revised to be more
consistent with how the term is used by
DEA and the Centers for Medicare and
Medicaid Services (CMS). This final
rule defines ''LTCF'' as a licensed entity
that provides assistance with activities
of daily living, including managing and
administering pharmaceuticals to one or
more individuals at the facility. This
definition includes, but is not limited
to, hospice facilities, nursing facilities,
skilled nursing facilities, and the
nursing and skilled nursing care
portions of continuing care retirement
communities. Not included within the
scope of this definition are group
homes, independent living
communities, assisted living facilities,
and the independent and assisted living
portions of continuing care retirement
communities.
The primary change we have made to
the proposed definition relates to
assisted living facilities. Under the
proposed definition, an assisted living
facility was considered a type of LTCF.
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See 21 CFR 1300.01.
168
Medicare Prescription Drug Benefit Manual-
Chapter 5, §
10.2, as cited by commenter EPA-HQ-
RCRA-2007-0932-0289.
169
See comment EPA-HQ-RCRA-2007-0932-
0242.
170
See comment EPA-HQ-RCRA-2007-0932-
0289.
171
Overview of Assisted Living, 2009, A
collaborative research project of American
Association of Homes and Services for the Aging
(AAHSA), American Seniors Housing Association
(ASHA), Assisted Living Federation of American
(ALFA), National Center for Assisted Living
(NCAL), and National Investment Center for the
Seniors Housing and Care Industry (NIC).
172
Regulatory Impact Analysis in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
173
See commenter EPA-HQ-RCRA-2007-0932-
0289.
Under the final definition, an assisted
living facility is not considered a type
of LTCF. This change is responsive to
commenter's concerns and will make
EPA's definition more consistent with
how the term is used by both DEA and
CMS. The DEA's definition of ''long
term care facility'' is ''a nursing home,
retirement care, mental care or other
facility or institution which provides
extended health care to resident
patients.''
167
DEA does not consider
assisted living facilities to be long-term
care facilities. CMS also does not
consider assisted living facilities to be
long-term care facilities. One
commenter pointed out that ''As
primary regulatory oversight of [assisted
living] resides at the state level,
regulatory requirements and applicable
definitions differ state by state. This is
why the Centers for Medicare and
Medicaid Services (CMS) excluded
[assisted living] in its definition of Long
Term Care Facilities.''
168
Furthermore, commenters argued, and
EPA agrees, that assisted living facilities
differ from LTCFs in at least two ways.
First, some assisted living facilities do
not provide medication management.
169
In some cases, assisted living facilities
are actually prohibited from managing
medications.
170
Second, many assisted
living facilities do not have on-site
nursing or other medical staff.
171
EPA
believes it is easier for implementation
of this rule, to make a determination
about assisted living facilities as a
category, rather than on the basis of
whether they provide medication
management of have on-site medical
staff. Therefore, for ease of
implementation as well as consistency
with DEA and CMS, EPA is not
considering assisted living facilities to
be long-term care facilities for purposes
of subpart P.
4. Comments and Responses
a. Long-term care facilities and the
household hazardous waste exclusion.
Aside from the comments about what
types of facilities should and should not
be considered LTCFs, we received many
comments about whether LTCFs should
be eligible to use the household
hazardous waste exclusion of
§
261.4(b)(1). Three states, the
Hematology/Oncology Pharmacy
Association, Stericycle, Inc., Healthcare
Waste Institute, National Waste and
Recycling Association, and Public
Employees for Environmental
Responsibility agreed that LTCFs should
be considered healthcare facilities and
therefore not eligible to use the
household hazardous waste exemption.
The American Society of Consultant
Pharmacists and the National
Community Pharmacists Association
disagreed with EPA's proposed change
of interpretation that hazardous waste
(including pharmaceuticals) generated
at LTCFs will no longer be considered
exempt as household hazardous waste.
The American Society of Consultant
Pharmacists expressed concern that this
change would be a substantial learning
curve for LTCFs and the costs may be
significant. Covanta Energy LLC
expressed concern that the impacted
facilities do not have robust financials
and would pass the costs on to
consumers. An assisted living
community commented that the facility
does not have the authority to compel
residents to surrender their medications
for disposal and therefore the new
requirement would cause the assisted
living community to be perpetually in
noncompliance. One state opposed
classifying group homes as healthcare
facilities rather than as households.
Waste Management National Services,
Inc. suggested that self-administered
pharmaceuticals that are under
residents' control should be considered
household waste.
EPA is finalizing that LTCFs are
included within the final definition of
healthcare facility. Accordingly, EPA is
also finalizing that hazardous waste
(including pharmaceuticals) generated
at LTCFs will no longer be excluded as
household hazardous waste: It will be
regulated as hazardous waste, subject to
the appropriate RCRA Subtitle C
management standards, including the
final subpart P management standards
for hazardous waste pharmaceuticals.
EPA is revising its interpretation with
regard to hazardous wastes generated at
LTCFs based on a reevaluation of how
such facilities operate. Specifically, in
order for hazardous waste to qualify for
the household hazardous waste
exclusion of §
261.4(b)(1), it must meet
the two criteria. EPA continues to
believe that hazardous waste generated
at LTCFs, does not meet either criterion
for the household waste exclusion.
In summary, EPA is finalizing that
LTCFs may no longer use the household
hazardous waste exclusion. LTCFs need
to manage their hazardous waste
pharmaceuticals in accordance with the
healthcare facility specific management
standards in this final rule and their
non-pharmaceutical hazardous wastes
in accordance with the applicable RCRA
hazardous waste generator regulations
in §
262.14 (for VSQGs), §
262.16 (for
SQGs), or §
262.17 (for LQGs), as well as
§
262.15 (for satellite accumulation
areas (SAAs)). However, even though
LTCFs will no longer be eligible to use
the household hazardous waste
exclusion, EPA estimates that there are
between 2,875 and 4,770 LTCFs that
generate hazardous waste and that 98-
99 percent of the facilities are VSQGs
regulated under §
262.14 and therefore
not subject to part 266 subpart P (except
the sewer prohibition, the empty
container provisions and the optional
provisions of §
266.504).
172
This means
that this change in policy will primarily
affect the larger long-term care facilities,
which are far fewer in number (1-2
percent of LTCFs).
It is also important to note that,
because of the change to the definition
of LTCF, this change in policy regarding
the household hazardous waste
exclusion and LTCFs will not impact
residents in assisted living facilities. As
discussed previously, assisted living
facilities will not be considered
healthcare facilities and therefore will
continue to be considered residences
that are eligible to use the household
hazardous waste exclusion in 40 CFR
261.4(b)(1). Under the household
hazardous waste exclusion, assisted
living facilities are not required to
manage their residents' hazardous
waste, including their hazardous waste
pharmaceuticals, under the RCRA
regulations. Commenters confirmed our
data that two-thirds of assisted living
facilities are small facilities with 25
residents or less, many of whom would
presumably be VSQGs.
173
Therefore, we
believe that this revised interpretation
will have minimal environmental
impact: instead of assisted living
facilities being exempt as VSQGs,
residential waste from assisted living
facilities will be exempt as household
hazardous waste. That said, under
RCRA, states may be more stringent
than the federal government and we are
aware that some states already have a
more stringent interpretation and do not
consider assisted living facilities to be
exempt from RCRA as households.
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49 FR 44978; November 13, 1984.
175
See RCRA Online #13736, March 1995.
176
See 73 FR 73525, December 2, 2008. Note that
while the Universal Waste proposal used the term
''hazardous pharmaceutical wastes,'' this final rule
uses the term ''hazardous waste pharmaceuticals''.
177
CareFirst, Commenter EPA-HQ-RCRA-2007-
0932-0239.
As noted previously, EPA's household
hazardous waste exclusion in 40 CFR
261.4(b)(1) exempts hazardous waste
that meets two criteria: (1) It is
generated on the premises of a
temporary or permanent residence for
individuals and (2) the waste stream is
composed primarily of materials found
in the waste generated by consumers in
their homes.
174
Therefore, only
hazardous wastes that are generated in
the residential areas of an assisted living
facility would be excluded as household
hazardous waste. On the other hand,
hazardous wastes that are generated by
an assisted living facility outside of the
residential areas would not be
considered excluded as household
hazardous waste. This interpretation
regarding non-residential hazardous
waste generated at assisted living is
consistent with our interpretation
regarding dry cleaning wastes generated
at hotels. Specifically, our interpretation
has been that while hazardous waste
generated in hotel rooms is excluded as
household waste, ''dry cleaning wastes
produced by the hotel do not meet both
criteria for household waste and will
not qualify for the household waste
exclusion.''
175
Similarly, when it comes
to assisted living facilities, this final
rule will rely on the interpretation that
we initially expressed in the preamble
to the proposed rulemaking to add
pharmaceuticals to Universal Waste:
''the [long-term care] facility itself may
generate hazardous waste as a result of
its central management of
pharmaceuticals in its pharmacy or
pharmacy-like area. These hazardous
pharmaceutical wastes would be subject
to the RCRA hazardous waste generator
regulations since the pharmaceuticals
are under the control of the facility, and
thus, the resulting wastes are generated
by the facility. However, patients and
residents in long-term care facilities
may generate hazardous wastes. Those
pharmaceuticals that are under the
control of the patient or resident of this
LTCF, when discarded, would be
subject to RCRA's household hazardous
waste exclusion (§
261.4(b)(1)).
Hazardous pharmaceutical wastes
generated by the resident are excluded
from regulation because they are
considered to be derived from the
household.''
176
Under the final rule, group homes and
independent living communities are
also not defined as LTCFs but rather are
considered residences that are eligible
to use the household hazardous waste
exclusion. An assisted living facility,
group home and independent living
facility are eligible for the household
hazardous waste exclusion whether they
are stand-alone facilities, or whether
they are part of a continuing care
retirement community. Conversely, a
nursing facility or skilled nursing
facility is considered a LTCF, and hence
a healthcare facility, whether it is a
stand-alone facility or part of a
continuing care retirement community.
Therefore, a continuing care retirement
community will likely have portions of
the facility that are excluded from RCRA
regulation as households, while other
portions of the facility will be regulated
under RCRA for their hazardous waste
generation and management, including
hazardous waste pharmaceuticals.
b. Other comments. Commenters
asked us to clarify the difference in
regulatory status between in-home
hospice care and in-patient hospice
facilities. One commenter points out
that ''Most hospice care is provided in
the private residence of a patient.''
177
Hazardous waste pharmaceuticals that
are generated by in-home medical care,
such as in-home hospice care, would be
eligible for the household hazardous
waste exclusion. On the other hand,
hospice facilities are not considered
residences and are not eligible for the
household hazardous waste exclusion.
Nevertheless, as discussed in section
XII.D. of this preamble, long-term care
facilities, including hospice facilities,
that have 20 beds or fewer will be
presumed to be VSQGs. Healthcare
facilities that are VSQGs are subject to
the sewer prohibition for hazardous
waste pharmaceuticals under this final
rule, the empty container standards in
§
266.507, and the optional provisions
of §
266.504, but otherwise are regulated
by the reduced regulations of 40 CFR
262.14 for the generation and
accumulation of hazardous waste,
including hazardous waste
pharmaceuticals.
IX. Applicability (§
266.501)
Part 266 subpart P was proposed to
replace the standard RCRA generator
regulations in part 262 for the
management of hazardous waste
pharmaceuticals by healthcare facilities
and reverse distributors. We proposed
separate regulations for healthcare
facilities and reverse distributors.
Further, we proposed separate
regulations for the management of the
two types of hazardous waste
pharmaceuticals-potentially creditable
hazardous waste pharmaceuticals and
non-creditable hazardous waste
pharmaceuticals. When a healthcare
facility disposes hazardous waste
pharmaceuticals directly by sending it
to a hazardous waste treatment, storage,
or disposal facility, we proposed that
these would be considered non-
creditable hazardous waste
pharmaceuticals. On the other hand,
when a healthcare facility disposes of
hazardous waste pharmaceuticals
indirectly through a reverse distributor
that facilitates manufacturer credit, we
proposed that these would be
considered potentially creditable
hazardous waste pharmaceuticals. We
proposed that when a reverse distributor
receives the potentially creditable
pharmaceuticals, it must evaluate them
to determine whether they need to go
onto another reverse distributor, in
which case the pharmaceuticals would
still be considered potentially
creditable, or whether they will go to a
TSDF, in which case they will be
considered evaluated hazardous waste
pharmaceuticals. Although EPA
proposed that potentially creditable
pharmaceuticals destined for reverse
distributors would be considered
hazardous wastes, we also recognized
that due to the considerable value they
retain in the form of potential credit
from manufacturers, there was a strong
incentive to manage them appropriately
and we did not need to apply the
standard RCRA regulations to them or to
the reverse distributors that manage
them. In contrast, once the credit has
been established for the evaluated
hazardous waste pharmaceuticals, the
incentive to manage them appropriately
no longer exists and we needed to apply
more rigorous regulations. This section
of the preamble discusses the types of
facilities and pharmaceuticals that are
and are not subject to this rulemaking.
Subsequent sections of the preamble
discuss the details of the regulations for
healthcare facilities managing non-
creditable hazardous waste
pharmaceuticals and potentially
creditable hazardous waste
pharmaceuticals as well as the
regulations that pertain to reverse
distributors managing potentially
creditable hazardous waste
pharmaceuticals and evaluated
pharmaceuticals.
A. What facilities are subject to the final
rule?
1. Healthcare Facilities (§§
262.10(n)
and 266.501(d))
a. Summary of proposal. The Agency
proposed that healthcare facilities that
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See §
262.14(a)(3) for accumulating >1 kg of
acute hazardous waste and §
262.14(a)(4) for
accumulating >1000 kg non-acute hazardous waste.
179
See comment number EPA-HQ-RCRA-2007-
0932-0341.
are not VSQGs will be required to
manage all hazardous waste
pharmaceuticals generated at their
facilities in accordance with the new
part 266 subpart P (see §
262.10(n)) in
lieu of the part 262 generator
regulations. In other words, we
proposed that these new management
standards apply to any healthcare
facility that generates more than 100 kg
of hazardous waste per calendar month
or more than 1 kg of acute hazardous
waste per calendar month (e.g., P-listed
hazardous waste) or more than 100 kg
of any residue or contaminated soil,
water, or other debris resulting from the
cleanup of a spill, into or on any land
or water, of any acute hazardous wastes
listed in §§
261.31, or 261.33(e) per
calendar month. We proposed that part
266 subpart P applies to all healthcare
facilities that generate above the VSQG
monthly quantity limits, including
LTCFs.
Further, we proposed that subpart P is
not optional for healthcare facilities that
generate above the VSQG monthly
quantity limits. EPA proposed to make
subpart P mandatory to promote
national consistency, a goal championed
by stakeholder comments as well as
EPA. We reasoned that having one set
of standards applicable to hazardous
waste pharmaceuticals would be less
confusing to the regulated community,
which should lead to better compliance.
We also proposed that any healthcare
facility that generates hazardous waste
above VSQG limits is subject to the
same set of standards for the
management of its hazardous waste
pharmaceuticals. That is, unlike under
part 262, the stringency of the proposed
regulations for healthcare facilities
operating under part 266 subpart P does
not increase as the amount of hazardous
waste generated increases. Put another
way, we proposed that there is no
generator category for hazardous waste
pharmaceuticals under part 266 subpart
P. The SQG and LQG categories under
the part 262 RCRA requirements will
only be relevant for the healthcare
facilities' non-pharmaceutical
hazardous waste because non-
pharmaceutical hazardous waste
remains subject to those 40 CFR part
262 generator regulations (along with
other applicable sections of the subtitle
C regulations).
We proposed that healthcare facilities
generating non-creditable hazardous
waste pharmaceuticals would be subject
to the management standards in
§
266.502, the sewer prohibition in
§
266.505, the conditional exemption for
hazardous waste pharmaceuticals that
are also controlled substances in
§
266.506, the empty container
standards in §
266.507, and the shipping
standards in §
266.508.
We proposed that healthcare facilities
generating potentially creditable
hazardous waste pharmaceuticals would
be subject to the management standards
in §
266.503, the sewer prohibition in
§
266.505, the conditional exemption for
hazardous waste pharmaceuticals that
are also controlled substances in
§
266.506, the empty container
standards in §
266.507, and the shipping
standards in §
266.509.
We expect that most potentially
creditable hazardous waste
pharmaceuticals will be sent to reverse
distributors; however, that may not
always be the case. For example, in
some cases, manufacturer credit can get
awarded without having to physically
send the potentially creditable
hazardous waste pharmaceuticals to a
reverse distributor. In such cases, we
proposed that if they are not destined
for a reverse distributor, then they must
be managed by the healthcare facility as
non-creditable hazardous waste
pharmaceuticals.
b. Summary of comments. Comments
on the applicability section addressed
several main areas of concern. First,
commenters weighed in on whether the
VSQGs should be subject to part 266
subpart P in its entirety, as opposed to
just the sewer prohibition. Second,
commenters weighed in on whether the
new subpart should be mandatory.
Third, commenters weighed in on our
proposed revision to our policy related
to the reverse distribution of
pharmaceuticals. While some
commenters agreed with our proposed
revised position that pharmaceuticals
going through reverse distribution
would be considered solid waste, many
commenters strongly objected to our
proposed revised position. We have
made several changes to the final
regulations that affect applicability,
although several of these changes are to
definitions, rather than to the
applicability section of §
266.501. The
primary focus of this section is to
discuss changes made to the
applicability section of §
266.501,
although changes to definitions that
affect applicability are also noted.
c. Final rule provisions. The final rule
applies to all healthcare facilities that
generate above any of the VSQG
monthly quantity thresholds. Healthcare
facilities that are not VSQGs do not have
the choice of opting into part 266
subpart P in lieu of part 262. Further, all
healthcare facilities that are subject to
part 266 subpart P are regulated the
same with respect to their hazardous
waste pharmaceuticals, regardless of
how much hazardous waste
pharmaceuticals they generate. Note
that we have made two changes to
§
262.10(n). First, we have revised the
regulations so that only a healthcare
facility that generates above the VSQG
quantity thresholds are subject to part
266 subpart P. A healthcare facility that
accumulates above the VSQG quantity
thresholds would not be subject to part
266 subpart P; it would remain subject
to part 262 (although as with any VSQG,
it would be allowed to opt into subpart
P). The 2016 Hazardous Waste
Generator Improvements final rule
amended the part 262 regulations to
make it clear that a VSQG that
accumulates above the quantity
thresholds must manage its hazardous
waste in accordance with the conditions
of either the SQG or LQG regulations,
but the generator would remain a
VSQG.
178
Second, in response to
comments, we have added the following
clarifying sentence at the end of the
paragraph: A healthcare facility that is
a very small quantity generator when
counting all of its hazardous waste,
including both its hazardous waste
pharmaceuticals and its non-
pharmaceutical hazardous waste,
remains subject to §
262.14 and is not
subject to part 266 subpart P, except for
§§
266.505 and 266.507 and the optional
provisions of §
266.504.
179
We have made four changes to the
proposed regulatory language of
§
266.501(d). First, we have made a
conforming change to reflect the change
in terminology in this final rule. That is,
in §
266.501(d)(1)(ii), ''pharmaceutical
reverse distributor'' has now been
replaced by ''reverse distributor.'' The
second change we made is to omit the
reference to §
266.504 in both
§
266.501(d)(1) and (2). Section 266.504
only applies to healthcare facilities that
are VSQGs and should not have been
referenced when discussing the
requirements for other healthcare
facilities. The third change is to clarify
in §
266.501(d)(2), that healthcare
facilities managing potentially
creditable hazardous waste
pharmaceuticals are also subject to the
notification and withdrawal standards
of §
266.502(a). While EPA believes it is
extremely unlikely that a healthcare
facility would only manage potentially
creditable hazardous waste
pharmaceuticals, as proposed, in this
situation a healthcare facility would not
need to notify as a healthcare facility.
EPA is clarifying in the final rule, that
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See comment numbers: EPA-HQ-RCRA-
2007-0932-0242 and EPA-HQ-RCRA-2007-0932-
0304.
should this situation arise, a healthcare
facility only managing potentially
creditable hazardous waste
pharmaceuticals and no non-creditable
hazardous waste pharmaceuticals is
subject to notification.
The fourth, and far more substantive
change we made is to §
266.501(d)(2).
This paragraph has been revised to
reflect our decision that healthcare
facilities are regulated under part 266
subpart P for the management of
prescription hazardous waste
pharmaceuticals going through reverse
distribution but healthcare facilities are
not regulated under part 266 subpart P
for the management of nonprescription
pharmaceuticals, such as OTCs,
homeopathic drugs, and dietary
supplements, going through reverse
logistics because they are not
considered solid or hazardous wastes,
provided they have the potential to be
lawfully redistributed or legitimately
reused or reclaimed. To summarize, part
266 subpart P applies to healthcare
facilities managing non-creditable
hazardous waste pharmaceuticals,
whether the pharmaceuticals are
prescription or nonprescription. But
part 266 subpart P applies to healthcare
facilities managing potentially
creditable hazardous waste
pharmaceuticals only if they are
prescription hazardous waste
pharmaceuticals. The comments we
received in this area and the reasoning
for our decision have been discussed at
length in section VI of the preamble to
this final rule.
Due to changes in the definition of
healthcare facility and LTCF, there are
effectively additional substantial
changes to the applicability of the final
rule. These two definitional changes
have already been discussed, but are
summarized here. In short, due to
changes to the definition of ''healthcare
facility,'' wholesale distributors will
now be regulated under part 266 subpart
P as healthcare facilities for the
management of their hazardous waste
pharmaceuticals. This includes 3PLs
when they perform the function of a
wholesale distributor. Unlike wholesale
distributors, 3PLs do not take ownership
of the pharmaceuticals; however, both
wholesale distributors and 3PLs take
physical custody of pharmaceuticals.
Under RCRA, a 3PL would meet the
definition of a hazardous waste
generator, regardless of whether they
own the hazardous waste
pharmaceuticals.
The final rule still applies to long-
term care facilities, because they are still
considered healthcare facilities.
However, we have amended the
proposed definition of LTCF such that
assisted living facilities will not be
considered long-term care facilities.
Further, we have finalized a rebuttable
presumption that long-term care
facilities with 20 beds or fewer will be
presumed to be VSQGs. The combined
impact of these changes is that this final
rule will apply to far fewer long-term
care facilities than the when the rule
was proposed.
In other respects, §
266.501(d) of the
final rule remains the same as the
proposal. That is, healthcare facilities
generating non-creditable hazardous
waste pharmaceuticals would be subject
to the management standards in
§
266.502, the sewer prohibition in
§
266.505, the conditional exemption for
hazardous waste pharmaceuticals that
are also controlled substances in
§
266.506, the empty container
standards in §
266.507, and the shipping
standards in §
266.508. And healthcare
facilities generating potentially
creditable hazardous waste
pharmaceuticals would be subject to the
management standards in §
266.503, the
sewer prohibition in §
266.505, the
conditional exemption for hazardous
waste pharmaceuticals that are also
controlled substances in §
266.506, the
empty container standards in §
266.507,
and the shipping standards in §
266.509.
Finally, if potentially creditable
hazardous wastes are not destined for a
reverse distributor, then they must be
managed by the healthcare facility as
non-creditable hazardous waste
pharmaceuticals. For example, if a
healthcare facility receives
manufacturer credit for a prescription
pharmaceutical without shipping it to a
reverse distributor, then the healthcare
facility is required to manage the
hazardous waste pharmaceuticals as
non-creditable hazardous waste
pharmaceuticals.
d. Comments and responses. Several
commenters asked us to consider
making part 266 subpart P an optional
alternative to part 262, instead of
mandatory. They argued that EPA's
previous sector- or waste-specific
regulations, such as the Academic
Laboratories Rule or Universal Waste,
are not mandatory and that generators
have the option to use them in lieu of
the standard RCRA generator
regulations under part 262. On the other
hand, several states agreed that having
''one set of standards will be less
confusing to the regulated
community.''
180
As discussed previously, part 266
subpart P will be mandatory for all
healthcare facilities generating above
VSQG monthly quantity thresholds.
Previous sector or waste specific
regulations have all been considered
either less stringent (Universal Waste) or
equally stringent (Academic
Laboratories rule) as the standard RCRA
generator regulations. In contrast, part
266 subpart P is considered, on the
whole, more stringent than the standard
RCRA regulations. EPA has never made
a more stringent RCRA regulation
optional. In part, this is because it seems
unlikely that anyone would opt into a
more stringent regulatory scheme. If
healthcare facilities chose to remain
operating under part 262, they would
not be subject to the sewer prohibition,
which is a cornerstone of this new
subpart.
Further, if part 266 subpart P were not
mandatory, another result would be that
healthcare facilities would not be able to
use the new provisions for empty
containers or the conditional
exemptions for hazardous waste
pharmaceuticals that are also DEA
controlled substances. But the most
important consideration is that this final
rule revises our previous policy
regarding pharmaceuticals being sent to
reverse distributors for manufacturer
credit such that they are now
considered solid, and possibly
hazardous, wastes. Under part 262, a
generator can only send its hazardous
waste to an off-site facility that has a
RCRA permit or interim status. This
would require reverse distributors to get
RCRA storage permits to be able to
accept hazardous waste from off-site. In
light of all these considerations, with
the exception of VSQG healthcare
facilities, EPA has concluded that it is
not feasible to make part 266 subpart P
an optional alternative to part 262.
That said, we recognize that some
commenters are concerned that this
final rule will impact their established
programs for managing hazardous waste
pharmaceuticals. In response, we would
point out that, in some cases, compliant
practices by healthcare facilities under
part 262 would also meet the standards
under part 266 subpart P. For example,
the training provisions for SQGs
(§
262.16(a)(9)(iii)) and LQGs
(§
262.17(a)(7)) would meet the training
provisions for healthcare facilities under
part 266 subpart P (§
266.502(b)). In fact,
the subpart P regulatory language for
training personnel at healthcare
facilities in managing non-creditable
hazardous waste pharmaceuticals is
identical to the regulatory language in
part 262 for SQGs. For labeling, under
part 266 subpart P, containers of non-
creditable hazardous waste
pharmaceuticals part 266 subpart must
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Note that the proposed rule used the term
''pharmaceutical reverse distributor'' but final rule
uses the term ''reverse distributor;'' therefore, the
preamble will use the term ''reverse distributor,''
even when discussing the proposed rule.
182
Not all authorized states recognize the VSQG
(or CESGQ) category and may have more stringent
regulatory requirements for VSQGs. Therefore, as
noted previously, EPA recommends that facilities
that qualify as VSQGs under the federal regulations
contact their state and/or local environmental
regulatory agencies to determine whether more
stringent regulatory requirements apply to VSQGs
in their state.
be labeled with the words ''hazardous
waste pharmaceuticals,'' but nothing
would prohibit additional labeling by
the healthcare facility. Likewise, under
part 266 subpart P, healthcare facilities
are not required to accumulate their
non-creditable hazardous waste
pharmaceuticals in a central
accumulation area (CAA), but nothing
would prohibit them from being
accumulated in a CAA. Furthermore,
healthcare facilities have up to one year
to accumulate non-creditable hazardous
waste pharmaceuticals on site under
part 266 subpart P, but nothing would
prohibit a healthcare facility from
accumulating for the shorter time-
frames dictated by the SQG (180 days)
or LQG (90 days) regulations in part
262.
2. Reverse Distributors (§§
262.10(m),
264.1, 265.1, 266.501(e), and 270.1)
a. Summary of proposal. The
proposed rulemaking responded to
stakeholders who have asked EPA to
clarify how reverse distributors are
regulated under RCRA, as states have
applied varied hazardous waste
regulatory approaches to reverse
distributors.
181
EPA proposed specific
standards in 40 CFR part 266 subpart P
for reverse distributors (as defined in
this proposed rulemaking) that
incorporated various generator
standards, as well as some TSDF
standards. EPA proposed that reverse
distributors that accumulate potentially
creditable hazardous waste
pharmaceuticals or evaluated hazardous
waste pharmaceuticals are subject to
this new subpart. We proposed that
reverse distributors are only subject to
part 266 subpart P for the accumulation
of potentially creditable hazardous
waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals; if a
reverse distributor also treats and/or
disposes of hazardous waste
pharmaceuticals, we proposed that it
would be subject to the applicable
RCRA Subtitle C TSDF regulations,
including the requirement to have a
permit or interim status. We proposed
that all reverse distributors would be
regulated the same for the accumulation
of hazardous waste pharmaceuticals
under part 266 subpart P, including any
reverse distributors that would be
considered VSQGs under part 262 (see
§
262.10(m)). Under the applicability
section in §
266.501(e), we proposed
that reverse distributors would be
subject to the sewer prohibition in
§
266.505, the conditional exemption for
hazardous waste pharmaceuticals that
are also controlled substances in
§
266.506, the empty container
standards in §
266.507, the shipping
standards in §
266.508 and §
266.509,
and the reverse distributor standards in
§
266.510, for the management of
hazardous waste pharmaceuticals. As
with healthcare facilities, if a reverse
distributor generates other, non-
pharmaceutical hazardous waste, it
remains subject to part 262 and all other
applicable portions of the Subtitle C
regulations (see §
266.501(c)).
b. Summary of comments. We
received a large number of comments
regarding the foundational question of
whether the pharmaceuticals going
through reverse distribution should be
considered solid or hazardous wastes. In
section VI of the preamble we have
responded thoroughly to that threshold
question; therefore, we do not elaborate
here. We received a few comments on
other areas related to the applicability of
part 266 subpart P to reverse
distributors, which have led to some
conforming changes in the final rule.
c. Final rule provisions. Other than
changing the term ''pharmaceutical
reverse distributor'' to ''reverse
distributor,'' we are finalizing the
regulatory text of §
262.10(m) and
§
266.501(e), as proposed. As a result,
all reverse distributors will be subject to
part 266 subpart P for the management
of their hazardous waste
pharmaceuticals instead of part 262.
This includes any reverse distributors
that would have been considered
VSQGs under part 262. This also
includes third-party logistics providers
(3PLs) when they perform the function
of a reverse distributor. Reverse
distributors and 3PLs acting as reverse
distributors do not take ownership of
the pharmaceuticals; however, both take
physical custody of hazardous waste
pharmaceuticals from off-site healthcare
facilities and both facilitate the
awarding of manufacturer credit for
potentially creditable hazardous waste
pharmaceuticals.
Under part 266 subpart P, there are no
generator categories for the
accumulation of hazardous waste
pharmaceuticals; all reverse distributors
will be regulated the same with respect
to the management of their hazardous
waste pharmaceuticals, regardless of the
quantity. All reverse distributors will be
subject to the sewer prohibition in
§
266.505, the conditional exemption for
hazardous waste pharmaceuticals that
are also controlled substances in
§
266.506, the empty container
standards in §
266.507, the shipping
standards in §
266.508 and §
266.509,
and the reverse distributor standards in
§
266.510, for the management of
hazardous waste pharmaceuticals.
d. Comments and responses. It is
important to note that, although we
have not made any substantive changes
to the applicability section of the
regulations pertaining to reverse
distributors, a change we have made to
the definition of reverse distributor has
effectively made a change to the
applicability of the final rule. Under the
final rule, the term ''reverse distributor''
has been narrowed considerably, so that
it only includes reverse distributors of
prescription pharmaceuticals. This
change has been described and
explained thoroughly in previous
sections of the preamble and will be
discussed here only briefly. In short,
under the proposed rulemaking, the
term ''pharmaceutical reverse
distributor'' included facilities that
facilitated manufacturer credit for both
prescription and nonprescription
pharmaceuticals (e.g., OTCs and dietary
supplements). In this final rule, we have
adopted the distinction drawn by
commenters between reverse
distributors, who manage prescription
pharmaceuticals, and reverse logistics
centers, who manage nonprescription
pharmaceuticals (and all other, non-
pharmaceutical retail items). While
reverse distributors are regulated by part
266 subpart P, reverse logistics centers
are not regulated by part 266 subpart P.
Additionally, we have made several
conforming changes to §§
264.1, 265.1
and 270.1. Specifically, we added
paragraphs §§
264.1(g)(13), 265.1(c)(16),
and 270.1(c)(2)(x). Together, these
paragraphs make it clear that reverse
distributors complying with the
conditions for accumulating hazardous
waste pharmaceuticals under part 266
subpart P are not required to operate
under the regulations for permitted
TSDFs in part 264 or interim status
TSDFs in part 265; nor are they required
to get a RCRA permit under part 270.
3. Very Small Quantity Generators
(§§
266.501(a) and (b))
a. Summary of proposal. VSQGs are
subject to a limited set of federal RCRA
Subtitle C hazardous waste regulations,
provided that they comply with the
conditions set forth in §
262.14.
182
We
proposed that subpart P would preserve
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See comment number: EPA-RCRA-HQ-2007-
0932-0242.
184
A VSQG healthcare facility that opts into part
266 subpart P for managing its hazardous waste
pharmaceuticals would still have to keep track of
its monthly generation of non-pharmaceutical
hazardous waste to verify that it is, in fact, a VSQG.
Assuming it is a VSQG, the healthcare facility could
manage its non-pharmaceutical hazardous waste
under §
262.14.
this current regulatory structure for the
most part, such that healthcare facilities
that generate hazardous waste
pharmaceuticals and qualify as VSQGs
would maintain their conditional
exemption under §
262.14 and would
not be subject to most aspects of the
proposal. However, as part of this
rulemaking, EPA proposed a prohibition
on sewer disposal of hazardous waste
pharmaceuticals by all healthcare
facilities, including VSQG healthcare
facilities (and all reverse distributors).
(See section XIII of this preamble for a
more detailed discussion on the sewer
prohibition.) We also proposed that
healthcare facilities that are VSQGs
would be able to use the standards in
§
266.504 for the management of their
hazardous waste pharmaceuticals, as
well as the standards in §
266.507 for
determining when their containers of
pharmaceutical are considered empty
(See sections XII and XV for detailed
discussion of those sections of the
regulations). We also proposed that
VSQG healthcare facilities would have
the ability to opt into using part 266
subpart P in lieu of the conditional
exemption in §
262.14.
b. Summary of comments. Many of
the comments on the applicability
section for VSQG healthcare facilities
were related to whether EPA should
maintain the conditional exemption for
VSQG healthcare facilities or whether
we should make them fully subject to
subpart P. Several commenters urged us
to be clearer in our regulatory language
and preamble about how a healthcare
facility determines whether it is a VSQG
or not. Although this section will
address this area of confusion, see
section IX.C of the preamble for
additional information about not
counting hazardous waste
pharmaceuticals toward generator
category when they are managed under
subpart P.
c. Final rule provisions. In the final
rule, healthcare facilities that are VSQGs
(when counting all their hazardous
waste, both hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste)
remain mostly exempt from part 266
subpart P. Note that all healthcare
facilities, including healthcare facilities
that are VSQGs, and all reverse
distributors are subject to the sewer
prohibition of §
266.505.
Healthcare facilities that are VSQGs
are also subject to §
266.504 which
includes optional provisions
specifically for healthcare facilities that
are VSQGs for both their hazardous
waste pharmaceuticals and their non-
pharmaceutical hazardous waste. We
note that although §
266.501(a) states
that VSQGs are subject to §
266.504, all
of the provisions in §
266.504 are
optional. For example, a healthcare
facility that is a VSQG operating under
§
262.14 for all of its hazardous waste is
not required to send its potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor.
Rather, we are providing a regulatory
mechanism that allows a VSQG
healthcare facility to use a reverse
distributor to obtain manufacturer
credit. Nor is a VSQG healthcare facility
required to send its hazardous waste
pharmaceuticals off site to be
consolidated at another healthcare
facility that is operating under subpart
P. Again, subpart P provides a
regulatory mechanism for those VSQG
healthcare facilities that wish to manage
their hazardous waste pharmaceuticals
in a more environmentally protective
manner. A VSQG that elects to use any
of the optional provisions of §
266.504
will not be considered to be opting into
subpart P. See section XII of the
preamble for a further discussion of
§
266.504.
Several states asked us to expand the
applicability of the final rule so that all
of the healthcare facility standards in
part 266 subpart P would be mandatory
for all healthcare facilities, including
VSQGs. For example, Colorado wrote
that '' .
.
. healthcare professionals can
be highly mobile across the healthcare
industry. As a result, professionals that
leave a hospital setting and move to the
[long-term care] setting have to relearn
a new process for waste management,
adding opportunity for more confusion
and mismanagement. Colorado strongly
encourages EPA to consider regulating
all healthcare facilities (including
CESQGs) that generate hazardous waste
pharmaceuticals under the proposed
regulations to minimize confusion and
promote consistency across the entire
spectrum of the healthcare industry
settings.''
183
Although we agree with
Colorado, we also believe that it would
pose a burden on the large number of
small healthcare facilities and divert
resources from regulatory agencies to
expand the applicability of the final rule
to include healthcare facilities that are
VSQGs. We have concluded that it
would be best to let the individual states
that adopt this new subpart to decide
whether to expand the applicability to
healthcare facilities that are VSQGs.
Additionally, in the final rule we have
retained the ability for healthcare
facilities that are VSQGs to opt into part
266 subpart P in lieu of operating under
§
262.14. A VSQG healthcare facility
may choose this option if it does not
want to have to keep track of how much
hazardous waste pharmaceuticals and
acute hazardous waste pharmaceuticals
it is generating on a monthly basis or if
it generates an unpredictable or
fluctuating amount of hazardous waste
pharmaceuticals each month that might
exceed one or more of the VSGQ
monthly quantity thresholds. If a
healthcare facility that is a VSQG
(counting all of its hazardous waste,
including pharmaceuticals and non-
pharmaceuticals) chooses to opt into
subpart P, it must comply with all the
standards for healthcare facilities
managing non-creditable hazardous
waste pharmaceuticals and potentially
creditable hazardous waste
pharmaceuticals, including notification
as a healthcare facility.
184
The VSQG
healthcare facility may not selectively
pick which provisions of part 266
subpart P it chooses to comply with; it
would be treated the same as any other
healthcare facility that is subject to part
266 subpart P. More specifically, if a
VSQG healthcare facility chooses to opt
into subpart P, then it would be subject
to all the provisions identified in
§
266.501(d) rather than the optional
provisions of §
266.504 for VSQGs or
§
262.14. The final regulatory language
has been amended to be more specific
in this regard. That is, rather than saying
a healthcare facility has the option of
complying with ''this subpart,'' we have
changed the regulations to say that a
healthcare facility has the option of
complying with ''§
266.501(d),'' which
identifies the specific sections of the
regulations that non-VSQG healthcare
facilities must comply with. Further, the
final regulatory language clarifies that a
VSQG healthcare facility that opts into
part 266 subpart P would no longer be
able to use the optional provisions for
VSQG healthcare facilities in §
266.504.
We have made four additional
changes to the applicability section of
the regulations pertaining to healthcare
facilities that are VSQGs. The first two
changes are conforming changes to
reflect the 2016 Hazardous Waste
Generator Improvements final rule; this
includes changing the term
''conditionally exempt small quantity
generator'' to ''very small quantity
generator'' and changing the regulatory
citation for VSQGs from §
261.5 to
§
262.14.
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See comment number: EPA-HQ-RCRA-2007-
0932-0280.
186
See comment number: EPA-HQ-RCRA-2007-
0932-0231.
187
See comment numbers: EPA-HQ-RCRA-
2007-0932-0231 and 0280.
The third change was made to address
commenters' concerns that the use of
the term VSQG in §
266.501(a) and (b)
was confusing. The Generator
Improvements final rule has now
defined the term VSQG in 260.10,
which should help reduce confusion.
Nevertheless, in response to the
comments, we also have added language
to §
266.501(a) and (b) to make it clearer
that we are referring to VSQGs that are
below the VSQG quantity thresholds for
all of their hazardous waste combined-
including both their hazardous waste
pharmaceuticals and their non-
pharmaceutical hazardous waste. Such
VSQGs are VSQGs for both their
hazardous waste pharmaceuticals and
their non-pharmaceutical hazardous
waste. In large part, VSQGs are not
subject to subpart P for the management
of their hazardous waste
pharmaceuticals (except the sewer
prohibition of §
266.505, the empty
container standards of §
266.507, and
the optional standards of §
266.504).
This type of VSQG stands in contrast to
what might be referred to as a ''subpart
P VSQG,'' meaning a healthcare facility
that generates over one or more of the
VSQG quantity thresholds and is
therefore subject to subpart P for its
hazardous waste pharmaceuticals but
becomes a VSQG for its non-
pharmaceutical hazardous waste after
complying with subpart P because it is
no longer required to count its
hazardous waste pharmaceuticals
toward its generator category.
The fourth change to §
266.501(a) is to
the reference to the new empty
container regulations of §
266.507. We
proposed in §
266.501(a) that a VSQG
would be subject to §
266.507(a) and (b).
In both the proposed and final rules,
these two paragraphs of §
266.507 define
when unit dose containers and
dispensing vials, and syringes,
respectively, are empty. The purpose of
the reference was to allow a healthcare
facility to use the new empty container
provisions in determining how much
hazardous waste pharmaceuticals it
generates and therefore whether it is
subject to subpart P. Under the final
rule, a healthcare facility is still able to
use the new empty container provisions
in §
266.507 when determining how
much hazardous waste pharmaceuticals
it generates, but we have concluded that
this reference should include all of
§
266.507, rather than just paragraphs (a)
and (b) because §
266.507 (c) and (d)
include provisions for determining
whether IV bags and other types of
containers of hazardous waste
pharmaceuticals are empty.
Additionally, we have also amended the
associated language in §
261.7 which
defines when a container of hazardous
waste is considered empty. We had
already proposed to add a new
paragraph (c) to §
261.7 to direct
healthcare facilities and reverse
distributors to §
266.507. The final rule
modifies the proposed paragraph such
that the new empty container
regulations in §
266.507 are no longer
limited to healthcare facilities and
reverse distributors operating under part
266 subpart P. Section 266.507 defines
when containers of hazardous waste
pharmaceuticals are empty and apply
regardless of whether they are being
managed by a healthcare facility, a
reverse distributor, or another entity.
Generators, including healthcare
facilities, can use the new provisions in
§
266.507 in determining when the
containers of hazardous waste
pharmaceuticals are empty and the
residues are no longer regulated as
hazardous waste. In turn, this will help
generators determine how much
hazardous waste they generate and;
therefore, whether they are subject to
part 266 subpart P and/or part 262. See
section XV of this preamble for further
information about §
266.507.
d. Comments and responses. A few
commenters had suggestions for
alternative organization or placement of
the applicability section pertaining to
healthcare facilities that are VSQGs.
One commenter suggested that we
combine all of the subpart P regulations
that pertain to VSQG healthcare
facilities in one place, under §
266.504,
rather than have some in §
266.501 and
others in §
266.504.
185
We generally
agree with the commenter and have
included all substantive standards for
VSQG healthcare facilities in §
266.504
(see section XII of the preamble for a
further discussion of §
266.504).
However, we believe that, when
discussing the central question of who
the subpart applies to, it is best to keep
together in §
266.501 all the regulations
that address applicability. And since the
applicability section of §
266.501
appears before the VSQG healthcare
facility standards of §
266.504, we
believe that it is more helpful to the
reader to know, up front in the
regulations, whether the subpart
applies. Another commenter thought we
should move the entire applicability
section so that it appears before the
definitions section in the regulations, in
order to allow ''the reader to determine
if [s]ubpart P applies to his facility
before reviewing any of its
requirements.''
186
Although we agree
that the applicability section is critical
to the reader, we believe that the reader
must have a full understanding of terms
used in the applicability section in
order to accurately determine whether
the subpart applies. As a result, we have
declined to make this suggested change.
We requested comment on whether the
applicability section for VSQG
healthcare facilities should appear in
§
262.14 (formerly §
261.5) rather than
in subpart P and a couple of
commenters responded that we
should.
187
Although that would have
been an acceptable option for crafting
the new regulations, we have concluded
that we prefer the option of keeping the
regulatory language related to hazardous
waste pharmaceuticals contained within
the same subpart when possible. As a
result, we have declined to make this
suggested change, as well.
B. What facilities or pharmaceuticals
are not subject to the final rule?
(§§
266.501(c) and 266.501(f) and
266.501(g))
1. Summary of Proposal
EPA proposed that the new part 266
subpart P management standards would
apply only to hazardous waste
pharmaceuticals generated or managed
by healthcare facilities and reverse
distributors. This new subpart was
designed as a sector-specific rulemaking
to address the unique circumstances of
the healthcare sector and the reverse
distribution of their hazardous waste
pharmaceuticals. In §
266.501(f), we
proposed that other entities that
generate or manage hazardous waste
pharmaceuticals would not be subject to
part 266 subpart P, but would remain
subject to the standard generator
regulations in part 262, along with other
applicable Subtitle C regulations. For
example, in the preamble to the
proposed rulemaking we stated that
pharmaceutical manufacturers and
wholesalers would remain subject to
part 262 generator regulations because
they do not face the same challenges
that healthcare facilities experience
when managing hazardous waste
pharmaceuticals. We reasoned that
manufacturers and wholesalers generate
hazardous waste pharmaceuticals that
are more predictable and the staff have
the necessary expertise to determine
which pharmaceuticals are considered
hazardous waste. However, we noted in
the proposal that when any facility,
including a pharmaceutical
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188
See 40 CFR 266.501(g)(1).
189
See comment number EPA-HQ-RCRA-2007-
0932-0353.
190
http://www.ncsl.org/research/health/state-
prescription-drug-return-reuse-and-recycling.aspx.
191
See Questions and Answers for the Public
Donating Drugs to International Humanitarian
Relief Efforts https://www.fda.gov/downloads/
newsevents/publichealthfocus/ucm249617.pdf.
192
http://www.who.int/selection_medicines/
emergencies/guidelines_medicine_donations/en/.
193
See comment number EPA-HQ-RCRA-2007-
0932-0353.
manufacturer, meets the definition of a
reverse distributor, it would be subject
to the new regulations for reverse
distributors with respect to those
operations.
In §
266.501(c), we also proposed that
this new subpart would only apply to
the management of hazardous waste
pharmaceuticals. The proposed new
subpart was sector-specific as well as
waste stream-specific. We proposed that
other, non-pharmaceutical hazardous
wastes generated or managed by
healthcare facilities and reverse
distributors would remain subject to all
applicable hazardous waste regulations.
2. Final Rule Provisions and Comments
and Responses
This final rule remains a sector-
specific rule as well as a waste stream-
specific rule. Accordingly, §
266.501(c)
of the final rule remains as proposed.
That is, a healthcare facility or reverse
distributor remains subject to all
applicable hazardous waste regulations
with respect to the management of its
non-pharmaceutical hazardous waste.
Likewise, as discussed previously, a
number of commenters requested that
we include wholesale distributors in
part 266 subpart P as healthcare
facilities and in response we have
amended the definition of healthcare
facility to include wholesale
distributors. This, of course, affects
which entities are subject to the rule,
but as we have made this change
through amending the definition of
healthcare facility, it does not
necessitate a change to §
266.501 of the
regulations, which is entitled
Applicability. Therefore, the final rule
applies to the generation and
management of hazardous waste
pharmaceuticals only by healthcare
facilities and reverse distributors and
not to others that might generate or
manage hazardous waste
pharmaceuticals, such as
pharmaceutical manufacturers.
We have added paragraph (g) to
§
266.501 of the final rule, substantially
expanding the list of types of wastes
that are not subject to part 266 subpart
P or to RCRA regulation in general. In
some cases, the additions grew out of
comments and in some cases, the
additions grew out the need for
additional clarity. Each of the types of
waste that are not subject to this subpart
are discussed individually below.
a. Donations. As discussed
previously, we have amended the
definition of hazardous waste
pharmaceutical to make it clear that a
pharmaceutical is not a solid waste, as
defined in §
261.2, and therefore, not a
hazardous waste, if it is lawfully
donated for its intended purpose. We
have made the same change to the
applicability section of this subpart to
similarly indicate that pharmaceuticals
are not subject to subpart P when they
are lawfully donated for their intended
purpose.
188
In fact, because
pharmaceuticals that are lawfully
donated or are otherwise legitimately
used/reused or reclaimed are not solid
wastes, as defined by §
261.2, they
would not be subject to RCRA at all.
Although this is common for
nonprescription pharmaceuticals, it is
rare for prescription pharmaceuticals.
Sirum, a commenter that is a non-profit
organization that ''helps implement
State-based programs to recycle unused
medication to indigent patients'' in four
states, concurred that ''repurposing
pharmaceuticals happens under narrow
circumstances'' and that ''in most cases,
pharmaceuticals transported back to a
reverse distributor are discarded by the
reverse distributor.''
189
State donation
and repository laws dictate the
conditions under which
pharmaceuticals may be donated. These
laws are tracked by the National
Conference of State Legislatures.
190
EPA
would note that, in addition to the state
regulations, the FDA has guidelines for
the donation of pharmaceuticals for
international relief efforts,
191
as does the
World Health Organization (WHO).
192
Sirum is providing a valuable and
commendable service and EPA does not
wish to impede their operations, which
support the waste minimization goal of
RCRA. We have amended both the
definition of hazardous waste
pharmaceutical and the applicability
section to clarify that pharmaceuticals
that are lawfully donated are not solid
or hazardous wastes and therefore are
not subject to RCRA, including this
subpart. This would include donations
to a charity, non-governmental
organization, or to a healthcare facility
that is participating in a donation or
repository program that is authorized by
the state. EPA concurs with Sirum that
this should act ''as an incentive and
path forward for socially responsible
reverse distributors [and others] to
donate rather than destroy
pharmaceuticals within the safety of
existing state laws that allow for these
practices.''
193
b. Over-the-counter pharmaceuticals
going through reverse logistics. As
discussed at length in section VI of the
preamble, OTC pharmaceuticals, and
other items meeting our definition of
pharmaceutical that do not require a
prescription, such as dietary
supplements, or homeopathic drugs,
will only be subject to this subpart
when they are discarded by a healthcare
facility. OTCs and other nonprescription
pharmaceuticals are not considered
solid or hazardous wastes when they are
sent through reverse logistics for the
purpose of determining whether they
can be redistributed for their intended
purpose or legitimately reused or
reclaimed. We have added
§
266.501(g)(2) to the applicability
section to codify this position regarding
OTC pharmaceuticals, dietary
supplements and homeopathic drugs.
c. Recalled hazardous waste
pharmaceuticals. The Agency initially
proposed standards for recalled non-
creditable hazardous waste
pharmaceuticals at healthcare facilities
in §
266.502(g)(3), and for potentially
creditable and evaluated hazardous
waste pharmaceuticals at reverse
distributors in §
266.510(a)(5). The
finalized recall provisions for all
hazardous waste pharmaceuticals are
now in the applicability section in
§
266.501(g)(3) and (4).
The Agency proposed that healthcare
facilities managing recalled non-
creditable hazardous waste
pharmaceuticals could request an
extension from the EPA Regional
Administrator should they need to
accumulate them for longer than the
allotted one-year period. Likewise, the
Agency proposed that reverse
distributors managing recalled
potentially creditable hazardous waste
pharmaceuticals could request an
extension from the EPA Regional
Administrator should they need to
accumulate them for longer than the
allotted 90-day period. In the proposed
regulations, the reasons for requesting
an extension were characterized as ''any
unforeseen circumstances beyond the
control'' of the healthcare facility or
reverse distributor. In the proposed
preamble, we gave the specific examples
of recalls and litigation as circumstances
that are the beyond the control of the
healthcare facility or reverse distributor,
which could require longer
accumulation than the proposed time
frames. The proposed provision in both
sections required that an extension
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request be sent in writing (electronic or
paper) to the EPA Regional
Administrator explaining the need for
the extension, the approximate amount
of hazardous waste pharmaceuticals
accumulated beyond the corresponding
time period, and the amount of extra
time requested. The Agency also
proposed to allow the Regional
Administrator discretion to grant,
modify, or deny extension requests on a
case-by-case basis. Lastly, the Agency
solicited comment on the proposed
mechanism to request a time extension.
The proposed recall provisions only
applied to hazardous waste
pharmaceuticals that had limited
accumulation times, i.e., non-creditable
hazardous waste pharmaceuticals at
healthcare facilities, and potentially
creditable and evaluated hazardous
waste pharmaceuticals at reverse
distributors. The finalized recall
provisions, however, apply to all
recalled hazardous waste
pharmaceuticals.
These proposed extension provisions
were opposed by many commenters
from both industry and state
governments. Industry commenters
were concerned about the additional
burden that would arise from having to
generate, transmit, and maintain an
additional set of records every time they
would need to request an extension of
the accumulation time period. The
commenters suggested that these
situations occur more often than EPA
indicated in the proposal. Similarly,
many state agencies were concerned
about the added burden imposed on
them by requiring notifications that
must be processed, analyzed, afforded
appropriate consideration, and
responded to. In addition, many
commenters mentioned the possibility
that these provisions would conflict
with other federal oversight authorities,
in particular, recalls overseen by the
FDA and CPSC. Commenters were also
wary of the discretion these proposed
provisions afforded the Regional
Administrator to grant extensions,
primarily due to the lack of a
mechanism to coordinate those
extensions with other agencies that
might require longer accumulation
times. Commenters were concerned this
would likely lead to a scenario in which
the EPA Regional Administrator does
not grant sufficient accumulation time
needed to comply with other federal
requirements for recalls.
To address these adverse comments,
the Agency has modified the final rule.
The modifications also address the fact
that the duration of a recall is highly
variable, making it unreasonable to
prescribe a specific time frame for
accumulation. The Agency is finalizing
provisions to ensure that recalled
hazardous waste pharmaceuticals are
properly managed without imposing
requirements that are superfluous or
conflict with other federal regulations
and procedures.
In an effort to avoid overreach and
potentially overlapping regulations, the
Agency consulted with FDA and CPSC
to better understand their procedures
and policies in regulating and
overseeing recalls of OTC and
prescription pharmaceuticals. We
learned that almost all pharmaceutical
recalls are overseen by FDA, however,
CPSC occasionally oversees a recall if an
item's packaging does not comply with
special (also called child resistant)
packaging requirements. We also
learned that third-party companies
(typically reverse distributors, as
defined in subpart P) serve as recall
facilitators contracted by the
manufacturer of the recalled item, to
provide recall logistics such as
aggregating recalled items, tracking
recall progress, and making disposition
determinations. Nearly all
pharmaceuticals sent to a recall
facilitator as part of a recall are
ultimately destroyed. However, in some
cases, the content of a recalled item is
reclaimed and put back into commerce.
For example, if the outer packaging has
incorrect information, the manufacturer
may choose to place the contents in
updated packaging so they can be
lawfully sold.
Although retailers are not permitted
to sell a pharmaceutical that is subject
to a CPSC recall, participation in a recall
is not compulsory on the part of every
consignee (entity that has purchased
those items), which means that there is
no way to compel participation,
whether the recall is voluntary or
federally mandated. The Agency had
considered taking the position that all
pharmaceuticals subject to a recall are
waste when the recall is issued.
However, because some recalled
pharmaceuticals have the potential to be
legitimately used/reused or reclaimed,
combined with the fact that they
sometimes can be lawfully dispensed by
the consignee (but not sold by a
retailer), we concluded that
pharmaceuticals subject to a recall do
not necessarily become waste simply by
virtue of being subject to that recall.
Although many pharmaceuticals
being sent by a healthcare facility to a
recall facilitator as part of a recall could
be considered solid waste, the Agency
has determined that the combination of
regulations, guidance and/or oversight
provided by FDA and CPSC is
sufficiently protective of human health
and the environment while
pharmaceuticals are subject to a recall.
Therefore, EPA is choosing not to apply
RCRA regulations on hazardous waste
pharmaceuticals that are subject to a
voluntary or federally-mandated recall
until the decision is made to send some
or all items for destruction (see below
for further discussion).
EPA is not attaching any requirements
to recalled hazardous waste
pharmaceuticals while subject to a
recall. In the final rule, healthcare
facilities and reverse distributors will
not be required to request an extension
of the accumulation time period for
recalled non-creditable hazardous waste
pharmaceuticals or potentially
creditable hazardous waste
pharmaceuticals as proposed. This
decision is also responsive to
commenters who were concerned about
having to operate under multiple and
possibly conflicting federal regulatory
schemes. It is also worth noting again
that FDA and CPSC are the only federal
agencies that regulate recalled
pharmaceuticals and special packaging
for pharmaceuticals, respectively.
When a pharmaceutical recall is
initiated, the manufacturer must
develop, and the corresponding agency
must accept, a recall strategy which
outlines all of the actions to be taken on
behalf of the manufacturer from start to
finish. A disposition determination is a
required component of a comprehensive
recall strategy. It is EPA's understanding
that items being managed under an FDA
or CPSC recall may be periodically sent
for destruction as part of the disposition
strategy (other disposition options
allowed by FDA and CPSC can include
redirection, and in rare circumstances,
reconditioning). It is at this point (upon
the decision to send some or all of the
recalled pharmaceuticals for
destruction) that the Agency will apply
RCRA regulations these hazardous
waste pharmaceuticals.
Any recalled pharmaceutical that is
sent for destruction as part of the
disposition strategy and is a RCRA
hazardous waste, must be managed
according to RCRA Subtitle C and any
applicable provisions of this new
subpart. This strategy is also in line
with FDA and CPSC recall procedures
in that they both specify that items
being sent for destruction must comply
with other applicable state, local and
federal regulations, which may include
DOT's Hazardous Material Regulations
(HMR) and RCRA. In other words, this
rule maintains the framework that any
entity sending recalled items for
destruction under a FDA or CPSC recall
must comply with RCRA regulations but
imposes these new subpart P regulations
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194
See the following three memos: (1) June 23,
2017, from Johnson to Regional RCRA Division
Directors, RCRA Online #14893; (2) August 11,
1988, from Lowrance to McGuire, RCRA Online
#11363; and (3) January 6, 2014, from Devlin to
Mitlo, RCRA Online #14881.
195
See 21 CFR 312.59.
at the point at which RCRA regulations
already applied in lieu of the generator
regulations in 40 CFR part 262.
d. Preservation orders, investigations,
and judicial proceedings. In addition to
recalls, the proposed rulemaking
included litigation holds as an example
of a circumstance that is beyond the
control of a healthcare facility or reverse
distributor, which would be a valid
reason to request an extension of the
accumulation period. Similar to the
proposed standards for recalled
hazardous waste pharmaceuticals, the
standards for hazardous waste
pharmaceuticals under litigation holds
were also included in §
266.502(f)(3) for
non-creditable hazardous waste
pharmaceuticals at healthcare facilities,
and in §
266.510(a)(5) for potentially
creditable and evaluated hazardous
waste pharmaceuticals at reverse
distributors. As with recalls, we have
moved the section of the regulations
that addressed accumulation time
extensions for litigation holds out of the
healthcare facility standards and reverse
distributor standards and into the
applicability section of §
266.501(g)(5).
The final rule also uses terminology that
is more encompassing than just
litigation holds, such that we are
choosing not to apply RCRA regulations
on hazardous waste pharmaceuticals
that are being held pursuant to
preservation orders, investigations, and
judicial proceedings (which would
include litigation holds).
194
Accordingly, the hazardous waste
pharmaceuticals under a preservation
order, investigation, or judicial
proceeding are not subject to part 266
subpart P until after the preservation
order, investigation or judicial
proceeding has concluded and/or a
decision is made to discard the
hazardous waste pharmaceuticals. As
with recalled hazardous waste
pharmaceuticals, the final rule no longer
requires healthcare facilities and reverse
distributors to request an extension of
the accumulation time period for
hazardous waste pharmaceuticals under
a preservation order, investigation, or
judicial proceeding, as was originally
proposed.
Some commenters were concerned
that the Agency had proposed that any
item under a preservation order,
investigation, or judicial proceeding
would be considered waste. We would
like to emphasize that non-waste
hazardous pharmaceuticals do not
automatically become a waste upon
being directed to participate in a
preservation order.
The Agency has determined that any
pharmaceuticals that were, prior to a
preservation order, investigation, or
judicial proceeding, determined to be
waste, are not subject to RCRA when
under the preservation order,
investigation, or judicial proceeding.
The Agency believes that sufficient
protections are in place to be duly
protective of human health and the
environment while the preservation
order, investigation, or judicial
proceeding is ongoing. In addition, the
extreme variability and
multijurisdictional nature of judicial
actions and Agency investigations make
it impractical to impose RCRA
standards while a corresponding
preservation order, investigation, or
judicial proceeding is ongoing. When
lifted-for any portion or the entire
complement of items-a new waste
determination must be made. The
location at which the waste
determination is made will be the new
point of generation. If the items are
ultimately determined to be hazardous
waste pharmaceuticals, all applicable
standards in this subpart apply and the
time frames for accumulation,
inventory, etc., begin anew.
e. Investigational drugs. Similar to
recalls, FDA has specific regulations
pertaining to investigational new drugs,
including that an investigational new
drug application must be developed and
approved by FDA, in accordance with
21 CFR part 312. These regulations
include a requirement that ''The
sponsor shall assure the return of all
unused supplies of the investigational
drug from each individual investigator
whose participation in the investigation
is discontinued or terminated. The
sponsor may authorize alternative
disposition of unused supplies of the
investigational drug provided this
alternative disposition does not expose
humans to risks from the drug.''
195
Because FDA requires these
investigational drugs to be returned to
the sponsor of the new drug application,
EPA would not consider these returned
investigational new drugs to be solid
wastes and therefore, they would not be
subject to RCRA, including this subpart.
However, when a decision is made to
discard the investigational new drug, or
when the FDA approves the destruction
of the investigational new drug, at that
point it would be considered a solid
waste, and if it is a hazardous waste,
then it would be subject to subpart P, if
the investigational new drug is
discarded by a healthcare facility or a
reverse distributor. However, typically,
investigational new drugs that are part
of a clinical trial are returned to the
manufacturer at the conclusion of the
clinical trial. In that case, if the
investigational new drug is discarded by
a manufacturer, then it would be subject
to part 262, not part 266 subpart P. We
have added §
266.501(g)(6) to carve out
investigational new drugs for which an
investigational new drug application is
in effect in accordance with the FDA
regulations in 21 CFR part 312. But we
have also included a sentence to make
it clear that, when the decision of
discard has been made, the
investigational new drug is subject to
subpart P, if it meets the definition of
hazardous waste and it is discarded by
a healthcare facility or a reverse
distributor.
f. Household pharmaceuticals. In the
proposed rulemaking, we indicated that
pharmaceuticals from households
would continue to be excluded as
household hazardous waste under
§
261.4(b)(1). However, this was only a
discussion in the preamble, we did not
include regulatory language in part 266
subpart P. Additionally, we proposed a
conditional exemption for collected
household pharmaceuticals in
§
266.507. For added clarity in the final
rule, we have included in the
applicability section a new paragraph
§
266.501(g)(7). This paragraph indicates
that household waste pharmaceuticals
are not regulated under part 266 subpart
P or other RCRA regulations. A
household waste pharmaceutical is
defined as a pharmaceutical that is a
solid waste, as defined in §
261.2, but is
excluded from being a hazardous waste
under §
261.4(b)(1). This exclusion is for
the residential generator of the
household waste pharmaceuticals, as
well as the collection and disposal of
the residential trash as municipal solid
waste.
As discussed later in this preamble,
we are finalizing a conditional
exemption in §
266.506(a)(2) for
household waste pharmaceuticals that
are collected in a take-back event or
program, including those that are
collected by an authorized collector (as
defined by the Drug Enforcement
Administration) registered with the
Drug Enforcement Administration that
commingles the household waste
pharmaceuticals with controlled
substances from an ultimate user (as
defined by the Drug Enforcement
Administration). To remain exempt as
household waste pharmaceuticals, these
collected pharmaceuticals may not be
sewered and have to be destroyed by a
method that the Drug Enforcement
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196
See comment number: EPA-HQ-RCRA-2007-
0932-0341.
Administration has publicly deemed in
writing to meet their non-retrievable
standard of destruction, or combusted at
one of the types of combustors
identified in §
266.506(b). We have
included in the applicability section in
§
266.501(g)(7) references to the
conditional exemption in §
266.506(a)(2)
and the conditions in §
266.506(b) to
clarify that household waste
pharmaceuticals that are collected as
part of a take-back event or program are
distinct and different from those that are
not part of a collection program. That is,
when discarded directly at a residence,
the household waste pharmaceuticals
remain excluded as household
hazardous waste, without any
conditions; however, when the
household waste pharmaceuticals are
collected in a take-back event or
program, they must be destroyed in
accordance with the conditions in
§
266.506 to remain exempt. See section
XIV of this preamble for a more detailed
discussion of the conditional exemption
for household waste pharmaceuticals
that are collected in a take-back event or
program.
C. Do Not Count Hazardous Waste
Pharmaceuticals Managed Under
Subpart P Toward Determining
Generator Category (§§
262.13(c)(9))
1. Summary of Proposal
EPA proposed that hazardous waste
pharmaceuticals that are managed under
part 266 subpart P are not required to
be counted in determining a facility's
hazardous waste generator category
under part 262. There were two primary
reasons this provision was proposed.
First, we received support for this
provision when we initially proposed it
as part of the 2008 proposal to add
pharmaceuticals to the Universal Waste
program. Second, and more importantly,
under part 266 subpart P, there are no
generator categories; therefore, it is not
necessary to know the quantity of
hazardous waste pharmaceuticals being
generated. EPA emphasized that a
healthcare facility must be managing its
hazardous waste pharmaceuticals under
subpart P in order to have the benefit of
not counting them towards its generator
category (see section XIX for further
discussion).
2. Summary of Comments
There was widespread support among
commenters for this proposed provision.
However, a number of the commenters
expressed some confusion and asked for
further explanation and clarity
regarding the effect this may have on
determining a facility's hazardous waste
generator category.
3. Final Rule Provisions
We are finalizing this provision with
a minor edit. Additionally, the
provision is now in a different place in
the final regulations. First, the minor
edit was made in response to
Connecticut Depart of Energy and
Environmental Protection's (CT DEEP)
objection to the phrasing of the
proposed regulatory language.
Specifically, CT DEEP thought the
phrase ''managed under 40 CFR part 266
subpart P'' could lead to confusion if a
healthcare facility was operating under
part 266 subpart P, but was not in full
compliance with part 266 subpart P and
whether that would be considered to be
''managed under 40 CFR part 266
subpart P.''
196
In response, and to avoid
this potential area of confusion, we have
changed the regulatory language so that
''a hazardous waste pharmaceutical
subject to or managed in accordance
with 40 CFR part 266 subpart P'' does
not have to be counted toward
determining a facility's generator
category. The second change is a
conforming change necessitated by the
reorganization of the generator
regulations in the 2016 Hazardous
Waste Generator Improvements final
rule. The list of hazardous wastes that
do not have to be counted toward
generator category had been listed in
§
261.5(c), but when the Hazardous
Waste Generator Improvements final
rule reorganized the generator
regulations, this list was moved to
§
262.13(c). Under this final rule,
hazardous waste pharmaceuticals that
are subject to part 266 subpart P do not
have to be counted toward determining
a facility's generator category. This
provision now appears in §
262.13(c)(9).
Finally, for clarity we have added that
the hazardous waste pharmaceuticals
that are also DEA controlled substances
and are conditionally exempt under
§
266.506, do not have to be counted
toward determining generator category.
4. Comments and Responses
Several commenters asked us to
clarify when a healthcare facility does
and does not count its hazardous waste
pharmaceuticals toward determining a
facility's generator category. A
healthcare facility must count all of its
hazardous waste-including hazardous
waste pharmaceuticals-to determine
whether it is subject to part 266 subpart
P. If a healthcare facility generates
below all of the VSQG monthly quantity
limits, then it remains subject to
§
262.14 for all of its hazardous waste
and it is not subject to subpart P for its
hazardous waste pharmaceutical, except
for the sewer prohibition of §
266.505,
the empty container standards of
§
266.507, and the optional provisions
of §
266.504. On the other hand, if a
healthcare facility generates above any
of the VSQG monthly quantity limits,
then the healthcare facility is subject to
subpart P for its hazardous waste
pharmaceuticals. But since subpart P is
only for the management of hazardous
waste pharmaceuticals, the healthcare
facility remains subject to part 262 for
its non-pharmaceutical hazardous
waste.
The next step is for the healthcare
facility to determine its new generator
category under part 262 so it knows how
to manage its non-pharmaceutical
hazardous waste. At this point, a
healthcare facility does not need to
count its hazardous waste
pharmaceuticals in determining its
generator category for its non-
pharmaceutical hazardous waste. EPA
continues to emphasize that a
healthcare facility must be managing its
hazardous waste pharmaceuticals under
subpart P in order to have the benefit of
not counting them towards its generator
category. Put another way, a healthcare
facility managing its hazardous waste
pharmaceuticals under subpart P does
not have a generator category for the
hazardous waste pharmaceuticals, but it
will be a VSQG, SQG or LQG for its non-
pharmaceutical hazardous waste.
When a healthcare facility that
manages its hazardous waste
pharmaceuticals under subpart P no
longer counts the hazardous waste
pharmaceuticals to determine its part
262 generator category, the healthcare
facility may experience a change in
RCRA generator category for its non-
pharmaceutical hazardous waste. For
example, a healthcare facility may shift
from being an LQG to an SQG or even
VSQG by not counting its hazardous
waste pharmaceuticals toward its
generator category, especially when
acute hazardous waste pharmaceuticals
such as warfarin (brand name:
Coumadin) no longer need to be
counted. A shift in generator category,
should it occur, would allow a
healthcare facility to manage its non-
pharmaceutical hazardous waste, such
as hazardous waste from laboratories,
according to the reduced part 262
generator regulations for a smaller
category.
For reverse distributors, it works
somewhat differently than with
healthcare facilities, because all reverse
distributors are subject to part 266
subpart P for the management of their
hazardous waste pharmaceuticals,
including reverse distributors that are
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VSQGs. In other respects, the
regulations work the same, because
reverse distributors also are not required
to count their hazardous waste
pharmaceuticals when determining
their part 262 generator category for
their non-pharmaceutical hazardous
waste.
Again, we emphasize, such dropping
down in generator category only
pertains to non-pharmaceutical
hazardous waste and is only possible
when the hazardous waste
pharmaceuticals are being managed
under subpart P. Further, EPA points
out that universal wastes also are not
counted toward a facility's generator
category and what we are finalizing for
hazardous waste pharmaceuticals has
been implemented successfully for years
within the universal waste program for
facilities that generate both universal
waste and other hazardous waste.
Below are a diagram and a table to
help summarize the preceding sections
of the preamble related to the
applicability of the final rule and the
provision that allows a healthcare
facility or a reverse distributor to not
count hazardous waste pharmaceuticals
when determining the facility's
generator category for its non-
pharmaceutical hazardous waste.
BILLING CODE 6560-50-P
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Diagram 1: When is a Healthcare Facility Subject to Part 266 Subpart P?
NO
Counting all hazardous waste,
including hazardous waste
pharmaceuticals and
non-pharmaceutical hazardous
waste, does the HCF generate:
1
> 1 kg acute HW /month, or
> 100 kg non-acute HW/month?
YES
HCF is a not subject to subpart P
except as noted
2
HCF is a VSQG under part 262 for
all of its hazardous waste,
including:
Is the hazardous waste a
pharmaceutical?
. hazardous waste
pharmaceuticals and
. non-pharmaceutical hazardous
NO
HCF manages its non-
pharmaceutical
hazardous waste under
part 262 as a
VSQG/SQG/LQG
HCF counts only non-
pharmaceutical HW to
determine monthly
generator category
YES
HCF manages its
hazardous waste
pharmaceuticals under
part 266 subpart P
HCF does not count HW
pharmaceuticals to
determine monthly
generator category
HW =Hazardous Waste HCF = Healthcare Facility RD =Reverse Distributor Rx =Prescription
1
Non-Rx pharmaceuticals are not solid or hazardous waste if they have a reasonable expectation of being
legitimately used/reused (e.g., lawfully redistributed for their intended purpose) or reclaimed. Reverse logistics
facilities are subject to the generator standards in part 262.
2
All VSQGs are subject to the sewer prohibition of§ 266.505 and the empty container standards of§ 266.507, and
can use the optional provisions of§ 266.504.
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Table 2: Applicability of Subpart P and Part 262 Generator Category for Healthcare Facilities
Hazardous Waste Non-Pharmaceutical
Part Part 262 Generator
Pharmaceutical Hazardous Waste
Total Hazardous Waste 266 Category of
Subpart Healthcare Facility
P?
Acute I Non-Acute Acute
I
Non-Acute Acute
I
Non-Acute LQG SQG VSQG
Any amount and >1 kg and/or ~1000 kg >1 kg and/or ~1000 kg Yes
../
Any amount and :::;1 kg and >100 and <1000 kg :::;1 kg and >100 and <1000 kg Yes
../
> 1 kg and/or> 100 kg and :::;1 kg and :::;100 kg > 1 kg and/or> 100 kg Yes
../2
:::;1 kg and :::;100 kg and :::;1 kg and :::;100 kg > 1 kg and/or > 100 kg Yes
../1.
:::;1 kg and :::;100 kg and :::;1 kg and :::;100 kg :::;1 kg and :::;100 kg No
1 ../3
Long-Term Care Facilities with:::; 20 beds No
1 ../4
1
All VSQGs healthcare facilities are subject to the sewer prohibition of§ 266.505, and the empty container standards of§ 266.507, and can use the optional
provisions in § 266.504
2
VSQGs for non-pharmaceutical hazardous waste only ("subpart P VSQG")
3
VSQG for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste
4
Presumed to be a VSQG for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste
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197
§
262.18(d)(2) requires LQGs to renotify EPA
by March 1 of each even-numbered year thereafter
using EPA Form 8700-12. An LQG may submit this
renotification as part of its Biennial Report required
under §
262.41.
198
EPA-HQ-RCRA-2007-0932-0341.
199
EPA-HQ-RCRA-2007-0932-0235.
X. Standards for Healthcare Facilities
That Manage Non-Creditable
Hazardous Waste Pharmaceuticals
(§
266.502)
A. Notification/Withdrawal
Requirements for Healthcare Facilities
Managing Non-Creditable Hazardous
Waste Pharmaceuticals (§
266.502(a))
1. Summary of Proposal
To address commenters' concerns
from the 2008 Pharmaceutical Universal
Waste proposal that regulatory agencies
are unaware of hazardous waste
pharmaceutical management activities,
EPA proposed to require that a
healthcare facility that does not qualify
as a VSQG to submit a one-time
notification as a ''healthcare facility'' to
the appropriate EPA Regional
Administrator. EPA proposed that
healthcare facilities subject to 40 CFR
part 266 subpart P will have to submit
a notification even if the healthcare
facility has previously obtained an EPA
identification number. The required
notification was meant to enable EPA
and state regulatory agencies to identify
the universe of healthcare facilities
managing hazardous waste
pharmaceuticals subject to the 40 CFR
part 266 subpart P requirements.
At any point, a healthcare facility's
hazardous waste pharmaceutical
generation may change due to waste
minimization efforts or other reasons,
causing the facility to legitimately
decrease its total monthly hazardous
waste generation enough to qualify as a
VSQG. In this case, if the healthcare
facility withdraws from the 40 CFR part
266 subpart P requirements due to
qualifying as a VSQG, EPA proposed
that the healthcare facility must re-
notify EPA of its choice to withdraw.
Alternatively, if a healthcare facility
determines that it is a VSQG, but does
not want to keep track of the amount of
hazardous waste pharmaceuticals it
generates and whether it is above or
below the VSQG threshold, we
proposed that it can choose to operate
under subpart P. By choosing to operate
under subpart P, the VSQG healthcare
facility must comply with all of the
requirements, including the one-time
notification that it is operating under 40
CFR part 266 subpart P. We proposed
that healthcare facilities that are not
VSQGs, however, are required to
operate under 40 CFR part 266 subpart
P for the management of their hazardous
waste pharmaceuticals.
The Agency proposed that this
notification occur using the RCRA
Subtitle C Site Identification Form (EPA
Form 8700-12; or Site Identification
Form). EPA believes that notification via
the Site Identification Form is the
preferred approach for notification
purposes for several reasons. First, both
state environmental regulatory agencies
and hazardous waste generators are
familiar with the form, as it is the form
currently used by hazardous waste
generators to notify regulators of their
RCRA Subtitle C activities. Second, as
stated previously, the use of the Site
Identification Form will allow for EPA
and state regulatory agencies to monitor
the healthcare facilities utilizing the
new regulatory requirements. Lastly,
public comments received on previous
EPA actions (e.g., Academic
Laboratories Rulemaking (73 FR 72912;
December 1, 2008)) have indicated that
notification via the Site Identification
Form is the notification approach
typically preferred by the regulated
community. We proposed that
healthcare facilities can submit their
notification as part of the Biennial
Report, if the healthcare facility will be
required to submit a Biennial Report
due to its non-pharmaceutical
hazardous waste. This was intended to
take advantage of an existing reporting
mechanism for LQGs or other generators
already required to submit the Biennial
Report and avoid duplicative
notification requirements. Otherwise,
healthcare facilities are required to
notify within 60 days of this new
subpart becoming effective, or within 60
days of becoming subject to this new
subpart. We also proposed that a
healthcare facility would have to keep a
record of its notification as long as it is
subject to this subpart.
The Agency did not anticipate that
the proposed notification requirement
would place any undue economic
burden upon healthcare facilities or the
environmental regulatory agencies that
process these notifications (see the
Regulatory Impact Analysis for the
proposed rulemaking in the rulemaking
docket EPA-HQ-RCRA-2007-0932). In
fact, under the proposed regulations,
healthcare facilities would no longer
need to count the hazardous waste
pharmaceuticals managed under 40 CFR
part 266 subpart P towards a healthcare
facility's generator category. As a result,
EPA anticipates that many healthcare
facilities will reduce their generator
category to either an SQG or VSQG for
their other non-pharmaceutical
hazardous wastes. So, while the
notification requirement ensures that
the environmental regulatory agencies
are informed of all hazardous waste
pharmaceutical management activities
subject to the 40 CFR part 266 subpart
P requirements, the fact that some
healthcare facilities will no longer
qualify as LQGs will reduce the number
of healthcare facilities in the LQG
universe.
The Agency solicited comment on the
notification requirement for healthcare
facilities, the method of notification via
the Site Identification Form, and
whether this notification requirement
will result in any undue burden to
either healthcare facilities or state
environmental regulatory agencies.
2. Summary of Comments
While there was general support for
requiring healthcare facilities to notify
the EPA Regional Administrator that
they are operating under this subpart, a
number of states and industry
commenters provided opposition to the
proposed 60-day time frame. States
supported notification but were
concerned that they would not be able
to process all of the notifications in a
timely manner given that all VSQG and
SQG facilities operating under subpart P
would have to notify within 60 days of
the effective date of this rule. One
suggestion was to instead require
notification on a rolling or staggered
basis to give resource-limited states
enough time to process the notices
within a timely manner.
States also voiced concern about the
provision allowing healthcare facilities
that are LQGs because of their non-
pharmaceutical waste to notify as part of
their normal Biennial Reporting
schedule.
197
Depending on the timing of
the Final Rule, states were concerned
about the possibility that LQGs would
not have to notify that they are
operating under this subpart for up to
two years, during the course of which
they could be generating large amounts
of pharmaceutical waste and managing
it under the reduced restrictions of this
subpart unbeknownst to the state or
EPA. Meanwhile VSQGs and SQGs
would have to notify within 60 days.
198
Another state recommended that
healthcare facilities be required to list
on the notification what their generator
category would be if they were to count
their pharmaceutical waste. The state
was concerned that a healthcare facility
could be generating LQG amounts of
pharmaceutical waste but because they
are now VSQGs, would be a much lower
inspection priority.
199
There was, however, no opposition to
the provision that a healthcare facility
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be required to maintain a copy of its
notification on file as long as it is
subject to this subpart.
3. Final Rule Provisions
EPA is finalizing the notification
provisions for healthcare facilities
managing non-creditable hazardous
waste pharmaceuticals as proposed,
with no changes.
All healthcare facilities as defined in
§
266.500 that are subject to the
requirements of this subpart (all
healthcare facilities that generate above
the VSQG thresholds and healthcare
facilities that are VSQGs choosing to
operate under this subpart) will have to
submit a notification to the EPA
Regional Administrator using the Site ID
Form (EPA Form 8700-12) stating that
they are a healthcare facility and will be
operating under this subpart. A
healthcare facility that already has an
EPA Identification Number must re-
notify the EPA Regional Administrator
that it will be operating under this
subpart within 60 days of becoming
subject to subpart P. Healthcare
facilities that do not have an EPA
Identification Number will be required
to obtain one by submitting the Site
Identification Form (EPA Form 8700-
12) within 60 days from the effective
date of this rule if they are not otherwise
required to submit Biennial Reports. A
healthcare facility that undergoes a
change in generator category causing
them to become subject to the
requirements of this subpart must notify
the EPA Regional Administrator within
60 days of the event that triggered the
change in generator category.
Healthcare facilities that are LQGs for
their non-pharmaceutical hazardous
waste, and therefore must submit a
Biennial Report, may notify the EPA
Regional Administrator according to
their normal reporting cycle. SQGs that
are required by their state to submit a
Biennial Report may also notify EPA
that they are operating under subpart P
on their normal reporting cycle.
Healthcare facilities that are required to
submit a Biennial Report are not,
however, required to wait to notify EPA
that they are operating under subpart P
on their Biennial Report, and may notify
EPA at any point prior to submitting the
Biennial Report. The Agency notes that
any healthcare facility that is required to
operate under subpart P must begin
complying with its requirements as soon
as the final rule becomes effective.
VSQGs that opt into subpart P may
notify the EPA whenever they choose,
but they become subject to the
requirements of this subpart on the date
they submit the notification. All
healthcare facilities must retain a copy
of the notification as long as they are
operating under this subpart.
4. Comments and Responses
Some states were concerned about
their ability to process notifications in a
timely manner given the 60-day time
frame after the effective date of this rule
within which all non-LQG healthcare
facilities must notify EPA that they are
operating under this subpart. The
Agency reasserts, however, that the
added burden is reasonable and
necessary for the Agency and
implementing states to gain a timely
understanding of the facilities within
the universe of this rule.
The Agency also notes that this final
rule goes into effect six months from the
date it is published in the Federal
Register in EPA Territories and states
that do not have an authorized RCRA
program. That time frame could be even
longer in authorized states which must
first adopt this rule for it to become
effective. Therefore, healthcare facilities
in all states have a minimum of six
months from the day this rule is
published in the Federal Register, plus
the 60 days in this requirement, to
notify their state that they are operating
under this subpart.
One commenter suggested that the
agency implement a staggered roll-out of
this notification provision to prevent
them from becoming inundated with
incoming notifications, preventing them
from processing notifications in a timely
manner. The Agency would note,
however, that there is no provision
requiring a healthcare facility to receive
approval before it can operate under this
subpart and states and regions can
process the notifications by whatever
time frames and methods they choose.
All healthcare facilities must operate
under this subpart immediately upon
becoming subject to this rule. Therefore,
as long as a healthcare facility that does
not submit a BR notifies its state within
60 days that it is operating under this
subpart, it will be in compliance. In
addition, we did not propose and are
not finalizing any time frames within
which regional or state offices must
process notifications, therefore, we defer
to those agencies to develop their own
best practices.
Another state suggested that EPA
develop a ''smart-form'' tool for
RCRAInfo-EPA's database of RCRA-
related information from required
reporting- that would allow healthcare
facilities to notify the state
electronically that they are operating
under subpart P, directly input their
own information, and update their
information on a regular basis. EPA
notes that it has developed an online
tool called myRCRAid which allows
generators to complete and submit the
Site Identification Form electronically,
which the Agency expects will reduce
states' administrative burden by
reducing the number of notifications
that have to be manually input, while
simultaneously reducing the potential
for error while transferring data.
In addition, the Site Identification
Form will be modified by EPA in a
separate action to add a section for a
healthcare facility to indicate that it
generates hazardous waste
pharmaceuticals. The healthcare facility
will no longer be required to identify on
the Site Identification Form the specific
types of hazardous waste
pharmaceuticals it generates. The
Agency also intends to add a checkbox
to the new section which will allow a
healthcare facility to indicate that its
generator category is changing to a
VSQG and it is no longer managing its
hazardous waste pharmaceuticals
according to 40 CFR part 266 subpart P.
Some states disagreed with the
provision that allows healthcare
facilities that file a BR to notify EPA that
they are operating under subpart P on
their normal reporting schedule, as
opposed to notifying within 60 days of
this rule becoming effective, or
becoming subject to subpart P. This
means that healthcare facilities that file
a BR could potentially operate under
this subpart for up to two years without
having to notifying the Agency,
depending on when their normal BR
date falls in relation to the effective date
of this rule. They recommended that all
facilities, regardless of generator
category, be required to notify within 60
days. While the Agency agrees that the
possibility for a healthcare facility to
operate for up to two years under this
subpart without notifying EPA does, in
fact, exist, we do not wish to impose
duplicative notification requirements.
One state requested that a healthcare
facility be required to list on the
notification what its generator category
would be if it were required to count its
hazardous waste pharmaceuticals. They
were concerned that some facilities that
are LQGs because of their hazardous
waste pharmaceuticals would reduce
their generator category as a result of
this rule, making them a low priority for
inspections, even though they could
still be generating LQG quantities of
pharmaceutical waste. We understand
the state's concern, however, making a
change like this would not be in line
with the goals of this rule to provide
streamlined standards. However,
options available to the states with
similar concerns are adopting more
stringent requirements or using
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§
262.16(b)(9)(iii)
201
40 CFR part 262.16 (a)(9)(iii).
202
40 CFR part 273.16.
historical notifications and Biennial
Report data.
B. Personnel Training Requirements for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(b))
1. Summary of Proposal
a. Performance-based training
standards. EPA believes that the part
262 LQG training regulations are
excessive for healthcare personnel who
sporadically generate hazardous waste
pharmaceuticals at healthcare facilities,
but believes it is necessary to have some
familiarity with the dangers that
hazardous waste pharmaceuticals can
pose, making the VSQG training
standards insufficient. Therefore, the
Agency proposed healthcare facility-
specific personnel training requirements
that are akin to the training
requirements for SQGs and small
quantity universal waste handlers, for
all healthcare facilities subject to
subpart P. Specifically, we proposed
that healthcare facilities managing
hazardous waste pharmaceuticals in
accordance with subpart P must inform
all employees that handle or have
responsibility for generating and/or
managing hazardous waste
pharmaceuticals of the proper handling
and emergency procedures appropriate
to their responsibilities during normal
facility operations and emergencies. We
indicated in the preamble to the
proposed rulemaking that this training
information can be disseminated
through verbal communication or
through distribution of pamphlets or
other documentation. However, a
healthcare facility that is an LQG due to
its non-pharmaceutical hazardous
wastes may choose to continue to use its
existing training program as an LQG so
as not to have different training
programs.
Under part 262 regulations, an LQG
healthcare facility had to provide full
RCRA training to its personnel involved
in the generation and/or management of
hazardous waste according to the
standards in §
262.17(a)(7). These
personnel training requirements include
either classroom instruction, on-line
training, or on-the-job training in RCRA
and require the facility to maintain
documentation of that training. On the
other hand, before this rule was
finalized, under the part 262
regulations, an SQG healthcare facility
had to meet a performance-based
standard when training personnel
involved in the generation and/or
management of hazardous waste
pharmaceuticals. Specifically, this
entailed ensuring ''that all employees
are thoroughly familiar with proper
waste handling and emergency
procedures relevant to their
responsibilities during normal facility
operations and emergencies.
''
200
For
comparative purposes, healthcare
facilities that are considered VSQGs did
not have any personnel training
requirements under the part 262
regulations. Similarly, SQGs and LQGs,
including healthcare facilities, were not
required to provide RCRA training to
personnel that only work in SAAs
regulated under §
262.15. That said,
healthcare personnel that are involved
in the generation of hazardous waste
pharmaceuticals must be familiar
enough with the pharmaceuticals with
which they work to know when they
have generated a hazardous waste so
that it will be managed in accordance
with the RCRA regulations.
b. Documentation of training.
Although no regulations were proposed,
EPA also sought comment in the
preamble to the proposed rulemaking on
whether documentation of training is
necessary in order to verify compliance
with the training requirement.
2. Summary of Comments
a. Performance-based training
standards. There were a variety of
comments on the proposed training
standards, both in support and
opposition. Although most states agreed
with the assessment that standard LQG
regulations would be excessive if
applied to healthcare facilities, some
wanted EPA to provide more stringent
and prescriptive language. Commenters
from the waste management industry
were also opposed to the proposed
performance-based standards for similar
reasons.
Pharmacy trade groups generally
agreed with the proposed standards,
citing the same rationale provided in the
preamble of the proposed rulemaking,
which states that the variability in waste
generated and turnover in employees
warrants a performance-based standard,
and any subsequent training should be
left up the healthcare facility. They
stated that most pharmacy staff are
trained on proper handling and
management of radiation and other
pharmaceuticals that can pose
significant risks as required by other
accreditation and standard-setting
agencies and any prescriptive training
standards under subpart P would be
duplicative.
b. Documentation of training. There
were mixed comments on whether to
require that a healthcare facility
document that its personnel have been
trained according to the standards set
forth in 40 CFR 266.502(b). All of the
states that commented on this issue
were supportive of the requirement to
document training. These states were
mostly concerned with their ability to
cite specific violations of the training
provisions during inspections. Another
state mentioned that many facilities
already maintain documentation of
training as a best management practice.
Waste management companies also
wanted EPA to require healthcare
facilities to document that employees
have been trained. They argued that the
training standards will not have their
intended effect if there is no
requirement for documentation because
healthcare facilities will not feel
compelled to comply with them.
Pharmacy trade groups were
concerned that requiring documentation
of training would result in added
burden and generally opposed this
provision. They argued that there are a
number of standard-setting and
accreditation agencies that already
require documentation that employees
have been trained, and as such, this
requirement would be redundant and
overly burdensome.
3. Final Rule Provisions
a. Performance-based training
standards. EPA is finalizing the
performance-based training standards as
proposed. A healthcare facility must
train employees to the extent that they
are thoroughly familiar with the proper
handling and emergency procedures
relevant to their responsibilities during
normal operations and emergencies. The
information can be disseminated
verbally, via printed materials, or other
means. These standards are similar to
the training standards for SQGs and
small quantity handlers of universal
waste.
201
202
The agency feels that these
standards provide consistency across
generator types and do not impose any
added burden on inspection and
enforcement actions beyond what is
already in place within the Universal
Waste program.
b. Documentation of training. EPA has
decided not to finalize a standard that
would have required healthcare
facilities to document that the
performance-based training standards
have been met. The Agency thinks this
requirement would have resulted in an
undue increase in the regulatory burden
for healthcare facilities. Also, there is no
such requirement in the part 262 SQG
training requirements or for small
quantity handlers of universal waste.
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§
268.3(c) Dilution prohibited as a substitute
for treatment. See appendix XI of part 268 for a full
list of hazardous wastes that are prohibited from
being combusted.
The agency feels this approach is
consistent with other RCRA regulations
and would improve consistency with
the Universal Waste program, especially
since the requirements for healthcare
facilities managing hazardous waste
pharmaceuticals were purposefully
modeled after the requirements for
small quantity handlers of universal
waste. The Agency ultimately
concluded that, because this approach is
sufficient for universal waste, it is also
acceptable for hazardous waste
pharmaceuticals.
4. Comments and Responses
a. Performance-based training
standard. There were a number of
commenters from states and the waste
management industry that
recommended more rigorous and
prescriptive training standards such as
more specific minimum requirements,
recurring training, and that the Agency
specify the job titles subject to the
training requirements. The Agency is
not finalizing any of these
recommendations, however, because we
believe that the proposed performance-
based standards are protective of human
health and the environment without
imposing undue burden either on states
or industry. These standards strike an
appropriate balance between ensuring
proper management of hazardous waste
pharmaceuticals and reducing the
regulatory burden on healthcare
facilities and healthcare personnel in a
manner that also encourages compliance
with these new regulations.
One commenter mentioned that
prescriptive RCRA training
requirements would be duplicative
given the training requirements of the
various accreditation entities. The
Agency responds that any waste
management training for healthcare
personnel would not be duplicative
because accreditation training typically
focusses on managing pharmaceuticals
prior to becoming a waste, whereas the
training required in subpart P is targeted
specifically at management practices
after the pharmaceuticals have become
waste. As mentioned previously, the
Agency is not finalizing prescriptive
training standards in an effort to
minimize regulatory burden and allow
healthcare facilities to tailor their
training programs in a way that best fits
their circumstances.
These training standards apply only
to healthcare personnel. Healthcare
personnel includes any person that
manages hazardous waste
pharmaceuticals at a healthcare facility
(e.g., employees, volunteers, students).
Environmental health and safety
personnel are likely to manage
hazardous wastes other than just
hazardous waste pharmaceuticals at a
healthcare facility, in which case, they
would be subject to other RCRA Subtitle
C training requirements.
The Agency acknowledges that there
are many pharmaceuticals that pose
significant risk to human health and the
environment, yet are not RCRA
hazardous when they become waste. We
in no way intend to imply that these
items pose any less of a risk by virtue
of being considered non-hazardous
under RCRA and encourage healthcare
facilities to provide all relevant training
to healthcare personnel and observe
industry best management practices.
b. Documentation of training. After
requesting comment on documentation
of training, the Agency decided not to
finalize any requirements for healthcare
facilities to document and maintain
records verifying that healthcare
personnel have met the training
requirements. We considered the many
adverse comments and ultimately
agreed that such requirements would be
overly burdensome and more stringent
than the training requirements in the
Universal Waste rule, which were
largely emulated in this rule. Many
comments that advocated for a
requirement to document training were
from states. Although such a
requirement is not being finalized at the
federal level, any authorized state has
the ability to impose more stringent
regulations. If a state chooses to require
documentation of training, that would
be considered more stringent and
permissible under RCRA.
C. Healthcare Facilities Making a
Hazardous Waste Determination for
Non-Creditable Pharmaceuticals
(§
266.502(c))
1. Summary of Proposal
EPA proposed that, similar to the
current part 262 generator requirements,
healthcare facilities operating under
subpart P would be required to make
hazardous waste determinations on
pharmaceutical wastes in order to
determine the applicable management
standards. Specifically, we proposed
that when a healthcare facility generates
a solid waste pharmaceutical, the
healthcare facility must determine if the
discarded pharmaceutical is listed in 40
CFR part 261 subpart D and/or if it
exhibits one or more of the four
characteristics of hazardous waste
identified in 40 CFR part 261 subpart C.
We proposed that, if the non-creditable
pharmaceutical waste is determined to
be a hazardous waste, then the
healthcare facility must manage the
non-creditable hazardous waste
pharmaceuticals in accordance with
part 266 subpart P instead of 40 CFR
part 262. Pharmaceutical wastes-both
potentially creditable and non-
creditable-not meeting the definition
of a hazardous waste (i.e., non-
hazardous waste pharmaceuticals) must
be managed in compliance with
applicable federal, state and local
regulations.
EPA understands that healthcare
facilities utilize various approaches
when making hazardous waste
determinations. For example, healthcare
facilities may hire consultants to review
their formularies and identify those
pharmaceuticals that are hazardous
wastes when discarded. These facilities
may then identify hazardous waste
pharmaceuticals at the pharmacy level,
marking these pharmaceuticals with a
special label so that healthcare
personnel know how to properly
dispose of the pharmaceutical when it
becomes a waste. Other healthcare
facilities may instruct personnel to
dispose of all pharmaceutical wastes
into one RCRA hazardous waste
collection container. These healthcare
facilities may then choose to manage all
of the contents of the container as
hazardous waste or they may choose to
sort the hazardous waste portion from
the non-hazardous waste
pharmaceutical portion in an on-site
hazardous waste accumulation area,
also known as a CAA. Due to the
various ways that healthcare facilities
make the hazardous waste
determination, the Agency did not
propose that a specific approach be
utilized when making the hazardous
waste determination, only that the
facility performs the hazardous waste
determination.
We also proposed that healthcare
facilities have the option to manage all
of their pharmaceutical wastes as
hazardous, and thus, if a healthcare
facility chooses this approach, they
would not need to make individual
hazardous waste determinations.
Instead, they would have made a
generic decision that all of their
discarded pharmaceuticals are
hazardous and manage them as
hazardous waste pharmaceuticals in
accordance with the requirements in 40
CFR part 266 subpart P. Accumulating
all non-creditable waste
pharmaceuticals in one container
(except for those that are incompatible
or cannot be incinerated according to
the dilution prohibition)
203
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Hazardous Waste Pharmaceuticals Wiki.
http://hwpharms.wikispaces.com. Wiki spaces is
phasing out its business of hosting wiki pages. The
Agency plans to preserve the information that has
been contributed to the wiki on EPA's website, but
the content will be static.
205
Healthcare Environmental Resource Center.
http://www.hercenter.org.
206
EPA makes no claims, promises, or guarantees
about the accuracy, completeness, or adequacy of
the contents of these sites.
managing them under subpart P would
relieve healthcare facilities from the
burden associated with making
individual hazardous waste
determinations.
2. Summary of Comments
There were a wide variety of
comments on this provision. Many in
the regulated community requested
some sort of a reference or compendium
containing a comprehensive and up-to-
date list of the waste pharmaceuticals
that would be considered RCRA
hazardous.
Commenters from states were
generally supportive of the provision
allowing all waste pharmaceuticals to be
managed as hazardous waste
pharmaceuticals. They believe the
provision will encourage healthcare
facilities to manage all of their waste
pharmaceuticals in an environmentally
protective manner. One commenter did
suggest that healthcare facilities be
required to choose whether they will
make individual hazardous waste
determinations for their waste
pharmaceuticals or manage all of them
as hazardous waste pharmaceuticals
under this subpart and maintain
documentation reflecting their decision.
Retail industry commenters were
opposed to what they believe are
contrary requirements, specifically,
allowing a healthcare facility to manage
all of its waste pharmaceuticals as
hazardous but still require them to
segregate incompatible hazardous waste
and those prohibited from combustion
as required by §
266.502(d)(4). They
believe having to segregate incompatible
and non-combustible waste significantly
diminishes the intended relief.
3. Final Rule Provisions
EPA has finalized the provisions of
this section with minor edits that
further clarify that this section applies
only to non-creditable pharmaceuticals.
A healthcare facility that generates solid
waste that is a non-creditable
pharmaceutical has two options for
hazardous waste determination. It may
choose to either; (1) determine if each
non-creditable pharmaceutical is a
listed or characteristic hazardous waste
to determine whether it is subject to the
subpart P requirements, or (2) manage
all of its non-creditable waste
pharmaceuticals under the subpart P
requirements as non-creditable
hazardous waste pharmaceuticals. A
healthcare facility that chooses the latter
option, instead of making individual
hazardous waste determinations at the
point of generation, would have made a
generic decision that all of their non-
creditable pharmaceutical waste is
hazardous and place it into a container
or containers that are managed under
part 266 subpart P.
The Agency wanted to provide
maximum flexibility to healthcare
facilities managing non-creditable waste
pharmaceuticals while ensuring
protection of human health and the
environment, which is why we are
finalizing the provision to allow
healthcare facilities the option of
managing all of their waste
pharmaceuticals under subpart P. If a
healthcare facility chooses to manage all
of its non-creditable waste
pharmaceuticals under the subpart P
requirements, healthcare personnel are
relieved from having to make individual
hazardous waste determinations which
might otherwise distract from their
efforts in providing patient care.
4. Comments and Responses
A number of commenters asked if a
third party can come on site and make
individual hazardous waste
determinations for commingled non-
creditable waste pharmaceuticals. If a
healthcare facility chooses to use a third
party, typically a hazardous waste
transport company, to come on site and
make hazardous waste determinations at
any time (typically in preparation for
transport off site), that would also be
permissible under this subpart.
Many comments were focused on the
lack of an EPA-provided reference guide
of which pharmaceuticals are hazardous
waste when discarded. The RCRA
generator regulations have always
placed the onus on the generator of a
waste to determine whether it is solid
and hazardous waste. Nevertheless, EPA
has made efforts to aid healthcare
facilities in making hazardous waste
determinations by developing the
Hazardous Waste Pharmaceuticals
wiki.
204
The website has served as a
central location where users (e.g.,
healthcare facilities, states) can share
their knowledge about which
pharmaceuticals are listed or
characteristic hazardous waste, and
other related information. EPA has also
funded a compliance assistance center
for healthcare facilities, which provides
information on which pharmaceuticals
are hazardous waste as well as other
hazardous wastes found in a healthcare
setting.
205
206
D. No Central Accumulation Area and
Satellite Accumulation Area
Requirements for Healthcare Facilities
Managing Non-Creditable Hazardous
Waste Pharmaceuticals
1. Summary of Proposal
Hazardous waste pharmaceuticals are
generated at numerous locations across
a healthcare facility. Under the part 262
generator regulations, each location at
the healthcare facility with a RCRA
hazardous waste receptacle for the
disposal of hazardous waste
pharmaceuticals is considered an SAA
and is subject to volume accumulation
limits and other provisions. Of
particular concern regarding the SAA
regulations for healthcare facilities is
the one-quart accumulation limit for
acute hazardous wastes (i.e., P-listed
wastes) and the requirement that
hazardous waste must be accumulated
at or near the point of generation. In
particular, hospitals have noted that
their difficulties are with having an
SAA in each hospital room. As a result,
the proposed December 2008
Pharmaceutical Universal Waste rule
did not require the establishment of any
accumulation areas (neither central nor
satellite) for hazardous waste
pharmaceuticals. This proposed
approach was consistent with the
current federal universal waste program,
since facilities are not required to
designate a special centralized area for
the accumulation of universal wastes,
nor are they required to have SAAs for
universal wastes. Nevertheless, EPA
understands that healthcare facilities
will often accumulate their universal
wastes within their 90- or 180-day
hazardous waste accumulation areas.
The part 262 generator regulations,
including the SAA and CAA
regulations, were designed more for
industrial and manufacturing
operations. Part 266 subpart P is a
sector-based regulatory approach
designed to work better with how the
healthcare sector operates. Therefore,
consistent with the approach initially
taken in the Universal Waste proposed
rulemaking, the Agency designed the
proposed standards for healthcare
facilities accumulating hazardous waste
pharmaceuticals under subpart P to
operate in lieu of the SAA regulations
or the CAA regulations (also sometimes
called '' less than 90- or 180-day are
as'').
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§
265.17 General requirements for ignitable,
reactive, or incompatible wastes is available.
https://www.gpo.gov/fdsys/pkg/CFR-2017-title40-
vol28/pdf/CFR-2017-title40-vol28-part265.pdf.
208
§
268.3(c) Dilution prohibited as a substitute
for treatment. See appendix XI of part 268 for a full
list of hazardous wastes that are prohibited from
being combusted.
209
See RCRA Policy Statement: Clarification of
the Land Disposal Restrictions' Dilution Prohibition
and the Combustion of Inorganic Metal-Bearing
Hazardous Waste. https://www.epa.gov/hw/policy-
statement-clarification-dilution-prohibition-and-
combustion-inorganic-metal-bearing.
2. Summary of Comments
The majority of commenters on this
provision were states. All but one state
and all other commenters agreed with
the proposal to eliminate requirements
for SAAs and CAAs for healthcare
facilities managing non-creditable
hazardous waste pharmaceuticals. The
lone dissenting state agreed with
eliminating requirements for SAAs but
expressed concern about not requiring
CAAs. They recommended that
hazardous waste pharmaceuticals be
accumulated in or near a 90-day or 180-
day accumulation area for LQGs and
SQGs respectively.
3. Final Rule Provisions
The agency is finalizing the approach
for part 266 subpart P to operate in lieu
of requiring CAAs and SAAs for
healthcare facilities managing non-
creditable hazardous waste
pharmaceuticals. The SAA regulations,
in particular, were not a good fit for how
healthcare facilities operate.
Additionally, there was near-unanimous
agreement among commenters that
SAAs and CAAs are not necessary to
accumulate hazardous waste
pharmaceuticals, further supporting the
agency's decision.
Although there is no requirement that
a healthcare facility accumulate its
hazardous waste pharmaceuticals in a
CAA, doing so is, nonetheless,
acceptable. A healthcare facility may
choose to accumulate hazardous waste
pharmaceuticals within its 90-day or
180-day CAA if it has one established
for its other hazardous wastes, as long
as it maintains compliance with the
accumulation time limit and container
requirements of 40 CFR part 266 subpart
P. If a healthcare facility chooses to
accumulate its hazardous waste
pharmaceuticals in a CAA, those
hazardous waste pharmaceuticals will
only be subject to the requirements of
part 266 subpart P and not the part 262
hazardous waste generator standards.
E. Container Standards for Healthcare
Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals
(§
266.502(d))
1. Summary of Proposal
The container standards discussed in
this section apply to those containers
used by healthcare facilities to
accumulate non-creditable hazardous
waste pharmaceuticals. First, we would
note that due to the relatively small
quantities of hazardous waste
pharmaceuticals that are typically
accumulated and stored at a healthcare
facility, the Agency understands that
other types of waste management units,
such as tanks, are not used for the
management of waste pharmaceuticals.
Therefore, we only proposed standards
for containers as defined in 40 CFR
260.10. However, the Agency solicited
comment as to whether other types of
waste management units are also used
by healthcare facilities to accumulate
and store hazardous waste
pharmaceuticals and whether EPA
should establish technical standards for
other types of waste management units.
The Agency proposed to require that
healthcare facilities place hazardous
waste pharmaceuticals into containers
that are structurally sound and that are
compatible with the hazardous waste
pharmaceuticals that will be contained
within them. EPA intends this
requirement to mean that containers
used for holding non-creditable
hazardous waste pharmaceuticals must
be in good condition, with no severe
rusting, apparent structural defects, nor
deterioration. EPA also proposed that
containers also must not have any
evidence of leakage, spillage, or damage
that could result in the release of waste
under reasonably foreseeable
circumstances. Furthermore, the Agency
proposed to require that incompatible
wastes not be placed in the same
container, unless the commingling of
incompatible hazardous wastes is
conducted in such a way that it does not
have the potential to (1) generate
extreme heat or pressure, fire or
explosion, or violent reaction; (2)
produce uncontrolled toxic mists,
fumes, dusts, or gases in sufficient
quantities to threaten human health; (3)
produce uncontrollable flammable
fumes or gases in sufficient quantities to
pose a risk of fire or explosions; (4)
damage the structural integrity of the
facility or container containing the
hazardous waste pharmaceuticals; or (5)
through other like means threaten
human health or the environment. For
example, the majority of a healthcare
facility's non-creditable hazardous
waste pharmaceuticals are likely organic
in nature, and thus, compatible with
each other and can be accumulated
together, especially since they will most
likely be incinerated once they are
transported to a TSDF.
The Agency believes that these
technical standards, like similar
technical standards that EPA has
promulgated in §
265.17(b) for interim
status TSDFs,
207
would ensure that
hazardous waste pharmaceuticals are
properly managed and would not be
released into the environment, while at
the same time providing flexibility to
the healthcare facility in selecting those
containers that are most appropriate for
their situation.
In addition to the proposed container
standards, the Agency also proposed
that accumulation containers for
hazardous waste pharmaceuticals be
secured in a manner that prevents
unauthorized access to the contents in
order to prevent the diversion of
hazardous waste pharmaceuticals or
inadvertent exposures to them. Unlike
most other hazardous wastes, some
hazardous waste pharmaceuticals might
still retain considerable value to
individuals or on the black market,
which can increase the likelihood of
diversion for illicit purposes.
Some non-creditable hazardous waste
pharmaceuticals, such as metal-bearing
wastes not containing sufficient
organics (e.g., P012, arsenic trioxide),
are prohibited from being incinerated
under the dilution prohibition.
208
Dilution is not a substitute for treatment
of certain restricted wastes because the
hazardous constituents are not
destroyed, removed, or immobilized
before being disposed of on the land.
209
EPA proposed that the hazardous waste
pharmaceuticals that cannot be
incinerated must be accumulated
separately from organic wastes destined
for incineration.
2. Summary of Comments
There was considerable interest in
this section with a broad range of
comments in support, in opposition,
and suggesting modifications. While
some states were in support of the
proposed standards, others were
concerned that they would not be easily
understood by healthcare facility
workers, and that we should provide
more detail about what constitutes a
closed container. There was also a
comment that recommended we clarify
that hazardous waste pharmaceuticals
can only be accumulated in containers,
and not tanks or other accumulation
units, and also what would constitute
an acceptable container. For example,
the commenter asked if re-sealable
plastic storage bags or plastic pill bottles
are considered a container under this
subpart.
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See comment number EPA-HQ-RCRA-2007-
0932-0257.
211
See comment number EPA-HQ-RCRA-2007-
0932-0216.
212
§
268.3 (c) Dilution prohibited as a substitute
for treatment.
213
§
266.506.
214
See memo November 11, 2011, Rudzinski to
the Regional RCRA Division Directors (RCRA
Online #14827).
Commenters from the waste
management industry were generally in
support of the proposed container
standards although one commenter took
issue with the security standards in 40
CFR 266.502(d)(3), stating that they are
not adequate and recommending that
we incorporate existing DEA guidance
on container security standards. The
commenter also suggested the final
regulations incorporate an additional
security provision stating that
hazardous waste pharmaceuticals be put
into a ''product or container that is
specifically designed to render them
inaccessible, non-consumable, and/or
irretrievable prior to final disposal.'' A
different waste management company
echoed the concerns shared by the
previously mentioned state that the final
rule should specify that hazardous
waste pharmaceuticals can only be
accumulated in containers and not in
other types of waste accumulation
units.
210
No commenters indicated that
any other types of waste management
units are used to accumulate hazardous
waste pharmaceuticals.
Trade associations representing a
range of stakeholders also generally
supported the proposed provisions but
were concerned about the requirements
to segregate hazardous waste
pharmaceuticals that cannot be
incinerated. One waste treatment trade
association recommended that the
regulatory language that allows the
incineration of certain mercury-bearing
hazardous waste pharmaceuticals be
changed to discourage the incineration
of such wastes even though it is
permissible. They believe that the
proposed language may be interpreted
as advocating for their incineration. A
state association was concerned about
the possible subjectivity of the language
in 40 CFR 262.502(d)(2), which contains
standards for facilities that manage
ignitable or hazardous waste
pharmaceuticals or that mix or
commingle incompatible wastes in the
same container. They recommend
instead, that the final rule employ the
''traditional prohibition'' on
incompatibility.
211
3. Final Rule Provisions
The Agency is finalizing the container
standards for non-creditable hazardous
waste pharmaceuticals as proposed. A
healthcare facility must place its non-
creditable hazardous waste
pharmaceuticals in containers that are
structurally sound, compatible with the
contents, and that would prevent any
leaks or spills under reasonably
foreseeable conditions. If incompatible
hazardous waste pharmaceuticals are
commingled in a container, the
healthcare facility must manage the
container such that it does not have the
potential to generate dangerous heat
and/or pressure, emit any toxic
substances (e.g., mists, fumes, dust),
produce flammable fumes or gases,
damage the structural integrity of the
container, or otherwise endanger human
health and the environment.
To address the concerns of
commenters, EPA would like to
emphasize that, while it is permissible
for hazardous waste pharmaceuticals
containing metals such as mercury to be
incinerated if the total organic carbon is
greater than 1%,
212
we strongly
recommend that they be segregated out
and treated via other acceptable
methods that comply with the land
disposal restrictions.
EPA is clarifying that the container
standards like the other standards for
non-creditable hazardous waste
pharmaceuticals do not apply to
hazardous waste pharmaceuticals that
are also DEA controlled substances
because these DEA controlled
substances are conditionally exempt
from RCRA.
213
Section XIV further
discusses hazardous waste
pharmaceuticals that are also DEA
controlled substances.
To reduce the risk of illicit diversion,
the Agency is finalizing the requirement
preventing unauthorized access to the
contents of containers used to
accumulate non-creditable hazardous
waste pharmaceuticals. EPA intended
this requirement to be performance-
based and did not finalize prescriptive
regulatory requirements for this
standard. Healthcare facilities may
choose to utilize containers that are
designed to prevent unauthorized access
to their contents when located in areas
with uncontrolled access or store
containers in areas with controlled
access, such as locked storage lockers,
locked closets, or locked rooms, to
prevent unauthorized access to the
contents of the containers. Containers
used to accumulate non-creditable
hazardous waste pharmaceuticals may
also be kept behind a pharmacy counter
because of the restricted access to those
areas.
The Agency received no comments
indicating that non-creditable hazardous
waste pharmaceuticals are accumulated
in any waste management units other
than containers. Therefore, these
standards apply only to containers used
to accumulate non-creditable hazardous
waste pharmaceuticals. Other types of
hazardous waste accumulation units are
not permitted for the accumulation of
non-creditable hazardous waste
pharmaceuticals.
4. Comments and Responses
Section (d)(4) of this provision
regarding the requirement to segregate
certain metal-bearing non-creditable
hazardous waste pharmaceuticals was
added as a reminder that, due to
existing LDR regulations, a few
hazardous waste pharmaceuticals
cannot be incinerated and therefore
must be segregated. This is not a new
requirement for healthcare facilities and
does not represent a change in the
regulatory burden.
One commenter asked if plastic bags
are considered a container as defined in
§
260.10. If hazardous waste is placed
inside a plastic bag, it meets the
definition of a RCRA container and is
subject to all applicable standards in 40
CFR 264 subpart I and 40 CFR 265
subpart I. Specifically, to be in
compliance, a plastic bag must be
compatible with the waste, able to
prevent the contents from leaking, kept
closed during storage except when it is
necessary to add or remove waste, and
handled or stored in a manner that
prevents rupture and/or causes leaking.
EPA would also note that, even though
this commenter did not mention other
types of containers, that cups, pill
bottles, vials, etc. are also considered a
container under RCRA.
214
Regarding the state association that
suggested EPA apply the ''traditional
prohibition'' on mixing or commingling
incompatible wastes in the same
container because they were concerned
about the possible subjectivity of the
five specified conditions in 40 CFR
262.502(d)(2), that regulatory language
was taken directly from the general
requirements for ignitable, reactive, or
incompatible wastes, in the General
Facility Standards at 40 CFR 265.17(b).
This is not a newly designed
requirement. Healthcare facilities that
manage hazardous waste
pharmaceuticals are already required to
comply with this provision.
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See comment numbers EPA-HQ-RCRA-2007-
0932-0333 and EPA-HQ-RCRA-2007-0932-0297.
216
See comment number EPA-HQ-RCRA-2007-
0932-0297.
217
See comment number EPA-HQ-RCRA-2007-
0932-0296.
218
Final rule: November 28, 2016; 81 FR 85808.
F. Labeling Standards on Containers for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(e))
1. Summary of Proposal
During the period of accumulation,
the Agency proposed that containers of
hazardous waste pharmaceuticals be
marked with the words ''Hazardous
Waste Pharmaceuticals.'' The Agency
did not propose to require that the
hazardous waste numbers (often
referred to as hazardous waste codes) of
the container's contents be listed on the
label. Healthcare personnel (e.g., nurses)
typically generate the hazardous waste
pharmaceuticals. Healthcare personnel
are not usually intimately familiar with
RCRA and its regulations and are
primarily focused on patients and their
health. In addition, while a healthcare
facility may have an environmental
compliance manager or environmental
consultant that is knowledgeable about
RCRA and its regulations and can make
hazardous waste determinations, this
individual cannot be present to assign a
hazardous waste code and label the
collection receptacle each time a
hazardous waste pharmaceutical is
generated. For these reasons, EPA did
not believe it would be practical to
require individual hazardous waste
codes on the hazardous waste
pharmaceutical collection container at
the healthcare facility.
The Agency solicited comment on the
appropriateness of the proposed general
labeling requirement. The Agency also
requested comment on security
concerns regarding having the word
''pharmaceutical'' marked on the
containers.
2. Summary of Comments
The issues of determining waste codes
and whether they should be required on
labels and/or manifests cuts across a
number of provisions in this rule. Many
commenters intertwined their opinions
on container labeling standards with
manifest requirements, waste code
determinations by healthcare workers,
and LDRs. While the Agency
understands the inter-relatedness of
these issues, this section pertains
specifically to the proposed standards of
requiring the words ''Hazardous Waste
Pharmaceuticals'' on containers used to
accumulate hazardous waste
pharmaceuticals, and whether having
the word ''Pharmaceutical'' displayed
on those containers increases the risk of
illicit diversion. Many of the comments
alluded to these container labeling
requirements during on-site
accumulation, but did not address them
directly, instead focusing on how the
proposed labeling standards to not
require hazardous waste codes on
containers will affect the manifesting,
shipping, and LDR processes. We will
address those comments in subsequent
sections as appropriate.
States had mixed views with a few
voicing support for the proposed
labeling standards, while another asked
that the Agency provide more leeway in
the required wording on the container
label. Another state agreed with not
requiring individual waste codes, but
recommended that EPA require some
sort of identification of potentially
incompatible wastes to help prevent
their inadvertent mixing. Two states
were opposed to the proposed standards
and recommended requiring individual
hazardous waste codes on container
labels to reduce the risk of
mismanagement and incorrect
treatment.
One reverse logistics company tacitly
agreed with the proposal to not require
hazardous waste codes on containers (or
manifests) and instead, write
''Hazardous Waste Pharmaceuticals'' on
the container and comply with DOT
requirements. They expressed
agreement with the agency's proposal to
not require hazardous waste codes on
the manifest, which leads the Agency to
conclude that not requiring hazardous
waste codes on containers is acceptable
to them as well.
Comments from the waste treatment
sector were mixed as well. One
commenter agreed with the proposal to
not require hazardous waste codes on
container labels but wanted more
flexibility in labeling. Other
commenters from the waste treatment
industry were wholly opposed to the
proposed labeling requirements citing
the need for waste codes by TSDFs to
meet LDR standards.
215
One medical waste trade association
did not explicitly agree that hazardous
waste codes should not be required on
container labels, but they did request
that, at a minimum, hazardous waste
codes should be included on the
manifest.
Stericycle initially disagreed with the
proposal to require the word
''pharmaceutical'' on labels in addition
to ''Hazardous Waste'' when it
commented on the 2008 proposal to add
pharmaceuticals to the Universal Waste
rule. It has subsequently, through first-
hand experience, determined that
including the word ''pharmaceutical''
on containers does not increase the risk
for illicit diversion. Therefore, in its
comments to this proposed rulemaking,
it is now in support of labeling
containers of hazardous waste
pharmaceuticals with the words
''Hazardous Waste Pharmaceuticals.''
Multiple commenters representing
regional and national healthcare
systems currently label their containers
with the word ''pharmaceuticals'' and
feel it is appropriate.
216
A commenter
from the healthcare waste association
also agrees that including the word
''pharmaceutical'' on containers is
current practice and does not present
any additional risk of diversion.
217
3. Final Rule Provisions EPA is
finalizing the container labeling
requirements as proposed. Specifically,
containers of non-creditable hazardous
waste pharmaceuticals must be marked
with the words ''Hazardous Waste
Pharmaceuticals'' when accumulating
on-site. This final rule provision is
consistent with the container labeling
requirements in the Hazardous Waste
Generator Improvements rule,
218
in that
generators are not required to label
containers with hazardous waste codes
during on-site accumulation.
Previously, the regulations did not
specify when hazardous waste codes
needed to be added to container labels.
The Agency was concerned about
increasing the risk of diversion resulting
from displaying the word
''pharmaceutical'' on a container.
However, given the general support
from commenters, in this final rule, EPA
is comfortable including the word
''pharmaceutical'' on the label of
containers used to accumulate
hazardous waste pharmaceuticals. There
was no opposition from commenters
representing healthcare systems and
pharmacy trade groups. In fact, many
commented that this is has been
standard practice for some time and has
not resulted in any increased diversion.
4. Comments and Responses
One state was concerned that
allowing the commingling of hazardous
waste pharmaceuticals could
inadvertently lead to incompatible
hazardous waste pharmaceuticals being
mixed together, and suggested that EPA
add a requirement to label containers
with potentially incompatible wastes. It
is the Agency's understanding that there
are only a few pharmaceuticals that are
incompatible according to DOT.
Pressurized aerosols are the most
common, although both DOT and EPA
are considering relaxing their
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219
Smith, Charlotte A. ''Managing
Pharmaceutical Waste: A New Implementation
Blueprint.'' Pharmacy Practice News, Special
Edition, 2011.
220
See comment number EPA-HQ-RCRA-2007-
0932-0280 in the docket for this rulemaking. The
regulation cited by the commenter has been since
moved to 262.16(b)(6) as part of the 2016 Hazardous
Waste Generator Improvements Final Rule.
221
Subsequent to the proposal, the Agency
became aware that the term ''litigation'' was not
sufficiently broad to encompass all of the legal
actions that might require a hazardous waste
pharmaceutical to be preserved. To maintain
consistency throughout the final rule, all instances
where the term ''litigation'' or ''litigation holds''
appeared in the proposed rule have been changed
to ''preservation order, investigation, or judicial
proceeding,'' except in this section which discusses
what was proposed.
management requirements in the near
future. Other DOT incompatible wastes
include oxidizers, acids, and bases, yet
they occur infrequently in dosage
form.
219
In addition, there are a limited
number of cases in which commingled
incompatible pharmaceutical waste has
caused a problem. Therefore, the
Agency has determined that the risk
does not rise to the level of requiring a
specific provision and is not finalizing
any additional labeling requirement for
incompatible hazardous waste
pharmaceuticals.
One commenter from the waste
management industry suggested that
EPA add the flexibility to label
containers of hazardous waste
pharmaceuticals with the words
''hazardous waste'' or other words that
communicate the hazards per
§
262.34(c)(1)(ii).
220
The Agency is not
finalizing this suggestion. EPA recently
revisited these provisions in the 2016
Hazardous Waste Generator
Improvements rule to require that
generators label containers with both
the words ''hazardous waste'' and other
words that indicate the nature of the
hazard partially because the Agency felt
that the previous requirements were too
vague. In addition, §
262.34 applied
only to containers in SAAs whereas
there are no SAAs in a subpart P
healthcare facility.
G. Accumulation Time Limits for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(f))
1. Summary of Proposal
a. One-year accumulation time limit.
A few hazardous waste pharmaceuticals
are P-listed acute hazardous wastes, the
most common being warfarin. Under the
part 262 generator regulations, if a
generator generates more than 1 kg of
acute hazardous waste per calendar
month, the generator is regulated as an
LQG and subject to a 90-day limit on
accumulation. Due to this low
generation/accumulation threshold
associated with P-listed wastes,
healthcare facilities are often LQGs.
However, while healthcare facilities can
generate enough P-listed waste to
become LQGs, they often do not
generate sufficient total amounts of
hazardous waste pharmaceuticals
within the allowed accumulation period
of 90 days to make off-site shipments
using a hazardous waste transporter
cost-effective.
Under the 2008 proposed amendment
to add pharmaceuticals to the Universal
Waste program, handlers of
pharmaceutical universal waste would
have had one year to accumulate their
hazardous waste pharmaceuticals in
order to facilitate proper treatment and
disposal. Commenters on the proposed
2008 Pharmaceutical Universal Waste
rule indicated support for the one-year
accumulation time limit. Thus, under
part 266 subpart P, the Agency proposed
to allow healthcare facilities to
accumulate non-creditable hazardous
waste pharmaceuticals for up to one
year without triggering interim status or
the need to obtain a RCRA permit. EPA
proposed one year as an appropriate
time frame because it strikes a balance
between allowing healthcare facilities
enough time to accumulate enough non-
creditable hazardous waste
pharmaceuticals to make it
economically viable to transport their
hazardous waste pharmaceuticals off
site while ensuring that the hazardous
wastes are not accumulated beyond the
one-year storage limit under the LDR
program (see §
268.50). Under the LDR
storage prohibition, the Agency assumes
that any accumulation for up to one year
is for the purpose of facilitating proper
treatment and disposal.
EPA proposed that healthcare
facilities could use various approaches
to demonstrate the length of time that
non-creditable hazardous waste
pharmaceuticals are accumulated on
site. For example, EPA proposed that a
healthcare facility can choose to mark
the container label with the date that
accumulation first began, maintain an
inventory system that identifies dates
when the hazardous waste
pharmaceuticals were first accumulated,
identify in the accumulation area the
earliest date that a hazardous waste
pharmaceutical became a hazardous
waste, or any other method that clearly
demonstrates the length of time that the
hazardous waste pharmaceutical has
been accumulated from the date it
became a hazardous waste.
b. Extensions to accumulation time
limits. In the proposed time frames to
accumulate non-creditable hazardous
waste pharmaceuticals, EPA included a
provision that allowed any healthcare
facility needing longer than the one-year
accumulation time frame to request an
extension from the appropriate EPA
Regional Administrator. The Agency
provided several examples of situations
when a healthcare facility might request
an extension. The reasons included
litigation (now referred to as
preservation orders, investigations or
judicial proceedings),
221
recalls, and
circumstances that are beyond the
control of the healthcare facility. The
proposed extension provision required
that healthcare facilities send a request
in writing (electronic or paper) to the
Regional EPA Administrator explaining
the need for the extension, the
approximate amount of hazardous waste
pharmaceuticals to be accumulated
beyond the one year, and the amount of
extra time requested. The Agency then
proposed to allow the Regional
Administrator the discretion to grant,
modify, or deny the requested extension
on a case-by-case basis. Lastly, the
Agency solicited comment on the
proposed mechanism to request a time
extension.
2. Summary of Comments
a. One-year accumulation time limit.
One commenter from industry agreed
with the proposed time limits, but
expressed concern about the ability of a
healthcare facility to track accumulation
times of their waste, and recommended
that there be an additional requirement
to inventory container contents in a
manner that will ensure that the 1-year
limit is not exceeded. Another state
commenter also recommended that
§
266.502(f)(2)(iv), which would have
allowed containers to be marked in ''any
other method which clearly
demonstrates the length of time that the
non-creditable hazardous waste
pharmaceuticals have been
accumulating from the date it first
became a waste,'' be eliminated because
it is too vague.
b. Extensions to accumulation time
limits. The proposed extension
provisions were opposed by a majority
of commenters from both industry and
state governments. Industry commenters
were concerned about the additional
burden that would likely arise from
having to generate, transmit, and
maintain an additional set of records for
a scenario (the need to accumulate
hazardous waste pharmaceuticals
beyond the one-year allotment) that they
say occurs more often than EPA seems
to have been aware of at the time of
proposal. Similarly, many state agencies
were concerned about the added burden
that would be imposed by a novel
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source of administrative workload in the
form of written requests that must be
processed, analyzed, afforded
appropriate consideration/discretion,
and responded to. In addition, many
commenters mentioned the possibility
that these provisions would conflict
with existing federal regulations, those
of FDA for recalls, in particular. Other
commenters brought up similar
concerns about pharmaceuticals being
stored pursuant to a litigation hold
because of their protracted and
unpredictable nature.
3. Final Rule Provisions
a. One-year accumulation time limit.
The Agency is finalizing a one-year
accumulation time limit for healthcare
facilities accumulating non-creditable
hazardous waste pharmaceuticals.
Healthcare facilities may use one of
three approaches to demonstrate the
length of time that non-creditable
hazardous waste pharmaceuticals are
accumulated on site. A healthcare
facility can choose to mark the container
label with the date that accumulation
first began, maintain an inventory
system that identifies dates when the
hazardous waste pharmaceuticals were
first accumulated, or identify in the
accumulation area the earliest date that
a hazardous waste pharmaceutical
became a hazardous waste.
The Agency reiterates that the one-
year accumulation time limit only
applies to a healthcare facility's non-
creditable hazardous waste
pharmaceuticals and does not apply to
any other types of non-pharmaceutical
hazardous waste generated on-site nor
to potentially creditable hazardous
waste pharmaceuticals.
The provision in §
266.502(f)(2)(iv)
has been eliminated. It would have
allowed for the accumulation start date
to be labeled in any manner that clearly
indicates the length of time that it first
began accumulating non-creditable
hazardous waste pharmaceuticals. One
commenter argued that the provision
was overly broad and EPA agreed.
b. Extensions to accumulation time
limits. The Agency is not finalizing any
of the proposed provisions in
§
266.502(f)(3) that would have allowed
a healthcare facility to request an
extension of the one-year accumulation
period for non-creditable hazardous
waste pharmaceuticals and has
addressed commenter concerns in other
areas of the rule.
Recalls and preservation orders,
investigations, or judicial proceedings
(formerly referred to as litigation in the
proposed rulemaking) were the two
specific situations that the Agency
attempted to address in the proposal as
examples of unforeseen circumstances
beyond the control of the healthcare
facility. Pharmaceuticals that are subject
to a voluntary or federally-mandated
recall (most likely overseen by FDA,
rarely CPSC) must be managed
according to the requirements of either
one or both agencies, as appropriate.
Although many of these items could
likely be considered RCRA solid waste,
EPA is choosing not to apply RCRA
regulations upon recalled
pharmaceuticals that are managed under
a voluntary or federally-mandated recall
until a decision is made to destroy those
items either in part or in whole.
Similarly, the agency also determined
that pharmaceuticals being stored
pursuant to a preservation order,
investigation, or judicial proceeding are
not RCRA hazardous waste. Both
scenarios are addressed in the
Applicability section of the final rule in
the preamble and regulations (see
§§
266.501(g)(4) and 266.501(g)(5)).
Because pharmaceuticals that have been
recalled and/or are being stored
pursuant to a preservation order,
investigation, or judicial proceeding are
not subject to this subpart, the Agency
does not see the need to include a
provision for extending accumulation
time. Recall managers (likely reverse
distributors) and states will not be
burdened by producing and responding
to such requests.
The proposed rulemaking also
discussed other unforeseen
circumstances (other than a recall or
preservation order, investigation, or
judicial proceeding) as a legitimate
reason for requesting an extension of the
one-year period to accumulation of non-
creditable hazardous waste
pharmaceuticals. However, the only
circumstances mentioned by
commenters that would necessitate an
extension were recalls and litigation
(preservation orders, investigations, or
judicial actions). Because both of those
scenarios are now addressed
individually in the finalized
Applicability section of the preamble
and regulations, and have no associated
accumulation time limits, the Agency
saw no need to codify a provision to
allow a healthcare facility to request an
extension of the accumulation time
limit for other reasons beyond their
control. Therefore, the EPA is not
finalizing the proposal to allow
healthcare facilities to request an
extension of the one-year accumulation
time frame from the Regional
Administrator for any reason.
H. Land Disposal Restrictions for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(g) and
§
266.502(d)(4))
1. Summary of Proposal
As required by HSWA and consistent
with part 262 generator requirements,
EPA proposed that healthcare facilities
must comply with the LDR
requirements prior to land disposal of
the hazardous waste pharmaceuticals
they generate. Since healthcare facilities
are generators, even though they are not
subject to the 40 CFR part 262
requirements for the management of
hazardous waste pharmaceuticals, we
proposed that they must comply with
the LDR requirements found at 40 CFR
part 268. The LDRs required by HSWA
are in place to ensure that toxic
constituents present in hazardous waste
are properly treated to reduce their
mobility or toxicity before hazardous
waste is placed into or onto the land
(i.e., land disposed). With limited
exceptions, hazardous waste must be
treated by a RCRA-permitted or interim
status TSDF.
In general, generators of hazardous
waste assign the appropriate hazardous
waste numbers (commonly called
hazardous waste codes) to allow TSDFs
to determine the specific treatment
standard(s) for each prohibited waste.
The Agency proposed that healthcare
facilities generating non-creditable
hazardous waste pharmaceuticals do not
have to label the containers with the
words ''hazardous waste'' or the
hazardous waste codes when
transporting them off site, but rather
must label the containers with the
words ''hazardous waste
pharmaceuticals.'' Healthcare facilities
do, however, need to make
determinations as to whether wastes
must be treated to meet LDR treatment
standards. While most hazardous waste
pharmaceuticals are likely organic in
nature and may be incinerated, some
hazardous waste pharmaceuticals may
not be suitable for incineration and,
therefore, must be segregated from the
organic wastes. The hazardous waste
pharmaceuticals not suitable for
incineration include characteristic metal
wastes (i.e., D004-D043) prohibited
from being combusted because of the
dilution prohibition of §
268.3(c), as
well as the listed wastes U151
(mercury), U205 (selenium sulfide), and
P012 (arsenic trioxide), unless they
contain greater than 1% total organic
carbon. Put another way, hazardous
waste pharmaceuticals with these
metals that also contain greater than 1%
total organic carbon may be incinerated.
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See 40 CFR 268.40 table ''Treatment Standards
for Hazardous Wastes,'' which identifies maximum
concentration values for all hazardous constituents
in the waste/treatment residue prior to land
disposal.
In order to comply with the LDRs,
healthcare facilities will need to
segregate these wastes from the organic
hazardous waste pharmaceuticals so
that they can be properly treated by the
TSDF. Although the Agency did include
a requirement to segregate these metal-
bearing low total organic carbon
hazardous waste pharmaceuticals in
proposed §
266.502(d)(4), the Agency
requested comment on whether it is
necessary to incorporate into the
regulations at §
266.502(g) a requirement
to segregate these wastes and whether
additional labeling requirements are
necessary to identify the hazardous
waste pharmaceuticals that are not
suitable for incineration.
Because EPA proposed that containers
of non-creditable hazardous waste
pharmaceuticals would not be required
to list the hazardous waste codes on the
label, we also proposed that waste codes
are not required on the LDR notification.
2. Summary of Comments
There were a variety of comments on
this provision, primarily regarding four
issues: (1) The segregation of hazardous
waste pharmaceuticals unsuitable for
incineration, (2) the incineration of
hazardous waste pharmaceuticals with
numeric treatment standards, (3) the
LDR notification, and (4) the need for
hazardous waste pharmaceuticals-
specific waste code and treatment
standard.
Commenters from both states and the
waste management industry requested
that the agency add a requirement for
healthcare facilities to segregate any
hazardous waste pharmaceuticals that
are unsuitable for incineration into
separate containers and label them with
the appropriate waste codes. They
argued that there would be an increased
likelihood that pharmaceuticals
containing metals subject to the dilution
prohibition would be inadvertently
incinerated, resulting in noncompliance
with LDR standards.
Many waste management companies
expressed concern about their ability to
meet LDR standards without knowing
specific waste codes and the added
burden they would incur from having to
test their ash for the seven hazardous
waste pharmaceuticals with numeric
treatment standards-lindane,
chloroform, m-cresol,
dichlorodifluoromethane,
trichloromonofluoromethane,
phenacetin and phenol.
222
They did,
however, agree that healthcare workers
should not have to make hazardous
waste determinations. They stated that
they would have to alter or augment
their testing protocols for residual ash
which would add undue burden. One
commenter suggested that, at a
minimum, segregation be performed
before a shipment of hazardous waste
pharmaceuticals are transported off site
for disposal, but having waste codes
either on a label or the manifest would
be preferable. They generally stated that
they do not feel waste management
should bear all of the added burden of
LDR compliance under this rule.
Another common theme among
commenters, from the waste
management industry in particular, was
a recommendation for a new, single
hazardous waste code for all hazardous
waste pharmaceuticals with a
corresponding alternate treatment of
standard of combustion (CMBST). One
commenter representing the retail
industry expressed concern that the
relief provided by this rule will be
negated by the requirement to list waste
codes on the LDR notice.
3. Final Rule Provisions
The Agency is finalizing the LDRs for
non-creditable hazardous waste
pharmaceuticals as proposed. The non-
creditable hazardous waste
pharmaceuticals generated by a
healthcare facility are subject to the
LDRs of 40 CFR part 268. A healthcare
facility that generates hazardous waste
pharmaceuticals must comply with the
land disposal restrictions in accordance
with §
268.7(a) requirements, except
that it is not required to identify the
hazardous waste numbers (i.e.,
hazardous waste codes) on the LDR
notification.
To address commenters' concerns
about whether hazardous waste codes
are required on the LDR notification, the
Agency has added clarifying language to
specify that waste codes are, in fact, not
required on the LDR notification. The
Agency would note, however, that the
proposed regulatory language did, in
fact, specify in §
266.502(g) that waste
codes are not required on the LDR
notice. Due to the number of
commenters who were under the
impression that waste codes would still
be required on the LDR notice, we
added an additional clarification to
make it more obvious that waste codes
are not required on the LDR notice.
The final rule requires healthcare
facilities that generate non-creditable
hazardous waste pharmaceuticals to
comply with the LDRs. In response to
comments, we have made one minor
change for added clarity. The Agency
has added a requirement to
§
266.502(d)(4) for healthcare facilities
that generate non-creditable hazardous
waste pharmaceuticals that are
unsuitable for incineration to segregate
them into separate containers from
those containing commingled non-
creditable hazardous waste
pharmaceuticals, and label them with
the appropriate hazardous waste codes.
We would note, however, that the
dilution prohibition of §
268.3 already
necessitates such segregation, therefore,
this addition in §
266.502 (d)(4) is for
the purposes of clarity and does not
substantially change any of the
proposed LDR requirements for
hazardous waste pharmaceuticals.
4. Comments and Responses
Waste management companies
opposed the provision to not require
healthcare facilities to label containers
with hazardous waste codes because of
the added burden they argue would
result from having to conduct additional
testing for pharmaceuticals with
numeric treatment standards.
Nevertheless, the Agency is not
finalizing a requirement for healthcare
facilities to label containers of non-
creditable hazardous waste
pharmaceuticals with hazardous waste
codes, nor is the Agency finalizing any
additional requirements for healthcare
facility personnel to segregate the seven
pharmaceuticals that have numeric
treatment standards, although a vendor
could include such a requirement in its
contract with a healthcare facility.
Unlike metal-bearing hazardous waste
pharmaceuticals that may not be
incinerated, the seven hazardous waste
pharmaceuticals with numerical
treatment standards may be incinerated
or treated using any other treatment
method to meet LDR values. Therefore,
the Agency thinks it would cause
confusion and add burden to require
healthcare facilities to segregate the
hazardous waste pharmaceuticals with
numeric treatment standards. Further,
the Agency has determined that several
of the seven organics with numeric
treatment standards also appear in non-
pharmaceutical hazardous waste, which
means that hazardous waste combustors
are already required to test their ash to
ensure compliance with LDRs for those
constituents.
Because this rule does not require that
healthcare facilities label their waste
with the hazardous waste codes, TSDFs
will now have to analyze their
incinerator residue (ash) for the seven
organics that have numerical treatment
standards according to the conditions
established in the facility waste analysis
plan, as they could possibly be present
in any shipment of organic hazardous
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Prohibited waste may be land disposed if it is
treated using the technology specified in the table
(e.g., CMBST:''), which are described in detail in
§
268.42, Table 1-Technology Codes and
Description of Technology-Based Standards.
224
See section VII.D.1.b for further discussion.
waste pharmaceuticals or treatment
residues. Organic hazardous waste
pharmaceuticals (other than arsenic
trioxide) may all be incinerated at
RCRA-permitted or interim status
hazardous waste combustors. Most
organic wastes have a specified
treatment standard of combustion
(CMBST). The remaining seven organics
have numerical treatment standards,
such that no particular treatment
technology is required to achieve the
numerical LDR treatment standards.
While these wastes may be incinerated,
the ash must be analyzed for these seven
organic constituents to demonstrate
compliance with the LDR treatment
standards before that ash can be land
disposed. The Agency is not finalizing
any standards that would affect the
frequency of testing, simply that TSDFs
test their ash for these seven
constituents as part of their existing
protocol.
EPA is not finalizing
recommendations from commenters that
the Agency implement a new waste
code or alternative treatment standards
specifically for hazardous waste
pharmaceuticals. Because the Agency
did not propose any new waste codes or
treatment standards for hazardous waste
pharmaceuticals, the recommendation is
outside the scope of this rule. The
Agency does agree that implementing an
alternative treatment standard of
combustion for hazardous waste
pharmaceuticals that currently have
numeric treatment standards would be a
viable solution to mitigate any added
burden imposed on TSDFs that will
have to modify their testing protocol;
however, we did not receive the
necessary data to propose such a change
prior to proposal, and therefore cannot
finalize an alternative treatment
standard in this rule. The Agency is,
however, open to considering
alternative treatment standards for
hazardous waste pharmaceuticals in
possible future rulemakings.
In their comments on this rule and the
2008 Universal Waste proposal,
Environmental Technology Council
(ETC) suggested revising the treatment
standards for the organic hazardous
waste pharmaceuticals that have
numerical treatment standards to the
specified treatment standard of
combustion. Specifying combustion
would relieve the TSDFs from
demonstrating compliance with the
numerical treatment standards.
223
EPA
explored the feasibility of making
combustion an alternative treatment
standard for the seven organic
hazardous waste pharmaceuticals that
currently have numeric LDR treatment
standards. In fact, EPA notes that the
numerical treatment standards were
developed based on levels achieved
through combustion. However, EPA has
indicated a preference for numerical
treatment standards over specifying
treatment standards whenever possible,
to allow maximum flexibility.
Furthermore, it is not clear that
pharmaceuticals would be the sole
source of the seven organic constituents
in question. Therefore, even if we
proposed an alternative treatment
standard of combustion for the seven
organic pharmaceuticals, hazardous
waste combustors would still be
required to test their ash for these
constituents to demonstrate compliance
with numeric treatment standards if
they received the organics from another,
non-pharmaceutical source.
Again, EPA notes that autoclaving is
not an acceptable method of treating
hazardous waste.
224
I. Procedures for Healthcare Facilities
Managing Rejected Shipments of Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(h))
1. Summary of Proposal
In rare circumstances, a healthcare
facility may send its non-creditable
hazardous waste pharmaceuticals to a
designated facility that is unable to
manage the hazardous waste. For such
situations, we proposed that healthcare
facilities follow the same procedures
listed in 40 CFR part 262 (see
§
262.23(f)). EPA believes that it is
appropriate to continue current
practices for rejected shipments that are
part of the generator regulations of 40
CFR part 262 because rejected
shipments are relatively rare and the
procedures currently used for rejected
shipments is relatively straightforward.
In addition, healthcare facilities should
be familiar with these procedures
already.
2. Summary of Comments
There were relatively few comments
on this section of the proposed
rulemaking. One state and one waste
management company agreed with the
standards as proposed. Another state
suggested that, as written, the regulatory
language contradicts itself. Specifically,
the commenter said that proposed
§
266.502(h)(4) implies that a healthcare
facility that receives a rejected shipment
of non-creditable hazardous waste
pharmaceuticals (a shipment that it
initiated) must offer it for shipment to
a new designated facility upon receipt,
as opposed to the 90-day additional
accumulation period mentioned in
§
266.502(h). They reason that, because
there are no time frames in the
requirement, the Agency intended to
mean upon receipt.
3. Final Rule Provisions
The agency is finalizing the
provisions in this section as proposed
with the added clarification that a
healthcare facility that sends a shipment
of non-creditable hazardous waste
pharmaceuticals to a designated facility
must have an understanding that the
designated facility can accept and
manage the waste. However, if the
healthcare facility later receives the
shipment back as a rejected load, the
healthcare facility must sign the
manifest that was used to return the
shipment, provide the transporter a
copy of the manifest, send a copy of the
manifest within 30 days to the
designated facility that returned the
shipment and ship the non-creditable
hazardous waste pharmaceuticals to a
new designated facility. The Agency
also added additional clarification to
§
266.502(h)(4), to respond to
comments, specifying that a healthcare
facility has up to 90 days to ship the
rejected shipment to a new designated
facility.
J. Reporting Requirements for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(i))
1. Summary of Proposal
We proposed that healthcare facilities
that are required to submit a BR would
no longer be required to include their
non-creditable hazardous waste
pharmaceuticals in the report. In
addition, the Agency proposed that
healthcare facilities managing non-
creditable hazardous waste
pharmaceuticals have reporting
requirements similar to generators
regulated under 40 CFR part 262-that
is, the exception reporting requirement
under §
262.44(b) and the additional
reporting requirement under §
262.44(c).
We proposed to incorporate and adapt
the generator exception reporting
procedures of 262.44(b) for this new
subpart. Specifically, we proposed that
if a healthcare facility does not receive
a copy of the hazardous waste manifest
from the designated facility within 60
days, the healthcare facility must submit
to the EPA Regional Administrator a
copy of the manifest with a statement
that the healthcare facility did not
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receive confirmation of the non-
creditable hazardous waste
pharmaceuticals' delivery, along with
an explanation of the efforts taken to
locate the non-creditable hazardous
waste pharmaceuticals and the results of
those efforts. Likewise, we proposed
that if a shipment of non-creditable
hazardous waste pharmaceuticals from a
healthcare facility is rejected by the
designated facility and it is shipped to
an alternate facility and if the healthcare
facility does not receive a signed copy
of the hazardous waste manifest from
the alternate facility within 60 days, it
must submit to the EPA Regional
Administrator a copy of the hazardous
waste manifest with a statement that the
healthcare facility did not receive
confirmation of the non-creditable
hazardous waste pharmaceuticals'
delivery along with an explanation of
the efforts taken to locate the non-
creditable hazardous waste
pharmaceuticals and the results of those
efforts.
Finally, the Agency proposed that the
Administrator may require healthcare
facilities to furnish additional reports
concerning the quantities and
disposition of hazardous waste
pharmaceuticals. This is already the
case for generators operating under the
40 CFR part 262. As with 40 CFR part
262, it is a codification of statutory
authority under §§
2002(a) and
3002(a)(6) that provides the Agency
some flexibility in what reports may be
required.
2. Summary of Comments
The Agency received few comments
on this subsection. Comments primarily
addressed there being no requirement to
include hazardous waste
pharmaceuticals on the BR, and
opinions were mixed. All pharmacy
trade groups that commented were in
favor of the proposal to not require
hazardous waste pharmaceuticals
managed under part 266 to be reported
on the BR. States that commented were
split. One state opposed the proposal
and argued it would hinder the state's
ability to reconcile what is treated at a
TSDF with what is generated at a
healthcare facility. Another state
disagreed with the proposed provision
and argued states will be forced to
establish their own reporting
requirements at the state level, leading
to inconsistency in the way states
determine their reporting fees. Another
state was in agreement with the
proposed provision, stating that
information regarding amounts of non-
creditable hazardous waste
pharmaceuticals generated and treated
can be captured from reverse distributor
and TSDF reporting. One other state
pointed out that the lack of a
requirement for healthcare facilities to
determine waste codes would make
reporting in the BR difficult, if not
impossible.
Regarding the exception reporting
requirements, one state suggested that
§
266.502(i)(2)(ii)(A) and (B) are
unnecessary because the requirements
in §
266.502 (i)(2)(i)(A) and (B) for a
healthcare facility that does not receive
a signed copy of the manifest within 60
days of being accepted by the initial
transporter are the same, whether the
shipment is lost or rejected and
transferred to a new designated facility.
The state suggested that §
266.502(i)(2)
should be rewritten to simply state that
an exception report is only necessary if
the healthcare facility has not received
the signed manifest from the TSDF
within 60 days. One healthcare provider
suggested that the proposed 60-day
period for a healthcare facility to receive
the manifest from the TSDF should be
shortened to 45 days because shipments
of other non-pharmaceutical hazardous
waste require receipt of the manifest
from the TSDF within 45 days.
3. Final Rule Provisions
The reporting requirements for
healthcare facilities managing non-
creditable hazardous waste
pharmaceuticals are being finalized as
proposed. That is, non-creditable
hazardous waste pharmaceuticals
managed under this subpart at a
healthcare facility are not required to be
reported on the BR, healthcare facilities
must submit an exception report to the
Regional Administrator if they have not
received a signed copy of the manifest
within 60 days of the initial transporter
accepting the shipment, and the Agency
may require a healthcare facility to
furnish additional reports regarding the
quantity and disposition of non-
creditable hazardous waste
pharmaceuticals. When managing
rejected shipments, the Agency believes
it is advantageous to use established
procedures that should be familiar to
healthcare facilities, especially given
that rejected shipments are relatively
rare.
To clarify, the exception reporting
regulations for healthcare facilities
differ from the exception reporting
regulations for reverse distributors
because they were based on the differing
§
262.42 exception reporting for LQGs
and SQGs. The exception reporting
regulations for healthcare facilities were
based on the corresponding §
262.42(b)
SQG regulations, whereas the reverse
distributor exception reporting
regulations were based on the
§
262.42(a) LQG regulations.
Although commenters voiced some
concern about not knowing the volume
of non-creditable hazardous waste
pharmaceuticals being generated at
healthcare facilities, the Agency
believes it is unnecessary to require
healthcare facilities generating non-
creditable hazardous waste
pharmaceuticals to report this
information. If a state or region wants to
obtain such information, it can examine
hazardous waste received forms in the
BR submission from TSDFs. Further,
one of the goals of this final rule is to
reduce burden on healthcare facilities so
that they will be encouraged to manage
all of their waste pharmaceuticals under
part 266 subpart P. Requiring a
healthcare facility to report hazardous
waste pharmaceuticals on its BR would
discourage them from managing non-
hazardous waste pharmaceuticals as
hazardous. Finally, we would note that
this approach is consistent with the
Universal Waste program upon which
the healthcare facility standards are
based. Universal wastes managed under
part 273 are not reported on the BR.
4. Comments and Responses
As part of the part 262 generator
regulations, healthcare facilities that are
LQGs must submit a BR to the Regional
Administrator by March 1st of every
even numbered year (see §
262.41).
Among other requirements, the BR must
include a description (EPA hazardous
waste number and DOT hazard class)
and quantity of each hazardous waste
shipped off-site to a TSDF during each
odd numbered year. If a healthcare
facility is an LQG due to its non-
pharmaceutical hazardous waste, it will
continue to be required to submit a BR
under part 262. However, it need not
include in its BR hazardous waste
pharmaceuticals managed under part
266. As discussed previously, the
Agency is no longer requiring healthcare
facilities to count hazardous waste
pharmaceuticals managed under part
266 when determining their generator
category under part 262. Instead, all
healthcare facilities, with the exception
of VSQGs, will be subject to this final
rule for the management of hazardous
waste pharmaceuticals. The Agency has
determined that it does not need the
information to be included in the BR
because this final rule will bring a
consistent approach to managing
hazardous waste pharmaceuticals.
One commenter suggested that the
time frame within which a healthcare
facility must receive a signed manifest
be shortened from 60 days to 45. The
Agency did not finalize that request
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because many standards in this final
rule were based upon SQG and
universal waste standards. Since no
manifest is required for transport and
there is no exception reporting standard
in the Universal Waste program, the
Agency used the 60-day time frame in
the part 262 SQG standards. LQGs have
a 45-day time frame to receive a signed
manifest from a designated facility.
Therefore, shortening the exception
reporting time frame from 60 days to 45
would not be consistent with the goals
of this rule to relieve the burden of LQG
standards on healthcare facilities
managing non-creditable hazardous
waste pharmaceuticals.
The Agency is not finalizing the
suggestion to unify the language in
§
266.502(i)(2) to cover both missing and
rejected shipments. The proposed
language was taken from the generator
requirements in §
262.42, which
addresses both situations separately.
The Agency is not aware of the existing
approach creating any problems for
generators and is finalizing the
regulatory language as proposed.
K. Recordkeeping Requirements for
Healthcare Facilities Managing Non-
Creditable Hazardous Waste
Pharmaceuticals (§
266.502(j))
1. Summary of Proposal
The Agency proposed that healthcare
facilities managing non-creditable
hazardous waste pharmaceuticals
maintain records similar to the records
that must be kept by generators
regulated under 40 CFR part 262 (see
§
262.40). Specifically, we proposed that
healthcare facilities must keep a signed
copy of each hazardous waste manifest
as a record for three years from the date
that the non-creditable hazardous waste
pharmaceutical was accepted by the
initial hazardous waste transporter. If
the healthcare facility is required to file
an exception report because it does not
receive a signed copy of the manifest
from the designated facility within 60
days of the date that the hazardous
waste pharmaceutical was accepted by
the initial transporter, then the
healthcare facility must keep a copy of
each exception report for a period of at
least three years from the date of the
report. In addition, EPA proposed that
a healthcare facility must keep records
of any test results, waste analyses or
other determinations made on
hazardous waste pharmaceuticals
regarding which pharmaceuticals are
hazardous wastes for three years from
the date of the test, analysis, or other
determination. The Agency also
proposed that any of the retention
periods be automatically extended
during the course of ongoing
enforcement actions against any activity
associated with hazardous waste
pharmaceutical management or as
requested by the Regional Administrator
to ensure that the appropriate records
are available and can be reviewed as
part of any enforcement action.
2. Summary of Comments
There were very few comments on
this proposed provision. All but one of
the commenters were states, all of
which agreed with the proposed
standard. One commenter suggested that
we specify that all three types of records
(manifest, exception reports, and test
results/analysis/waste determinations)
be kept on site.
3. Final Rule Provisions
The recordkeeping requirement is
being finalized as proposed, with two
changes. First, the Agency added a fifth
provision in §
266.502(j)(5) to address
comments requesting that all records be
kept on site. The added provision also
requires that all records must be readily
available upon request by an inspector.
The Agency understands that some
records may be kept at off-site locations
(e.g., headquarters), which is acceptable
as long as those records are able to be
produced in a timely manner upon the
request of an inspector.
The second change was an addition to
§
266.502(j)(3) that relieves a healthcare
facility from the requirement to retain
documentation of hazardous waste
determinations in §
266.502(c) if it
chooses to manage all of its non-
creditable waste pharmaceuticals as
hazardous waste under subpart P. As
discussed elsewhere, a goal of this rule
is to encourage healthcare facilities to
manage all of their waste
pharmaceuticals under subpart P to
reduce the amount of pharmaceuticals
entering surface and groundwater via
sewering and landfill leachate. The
relief provided in §
266.502(j)(3)
provides additional incentive for
healthcare facilities to manage their
non-creditable non-hazardous
pharmaceutical waste under subpart P.
A healthcare facility must keep a copy
of the signed manifest for a period of at
least three years from the date the
shipment was accepted by the initial
transporter. A healthcare facility must
also keep a copy of any exception report
for a period of at least three years from
the date of the report. To make the
recordkeeping consistent with the 2016
Generator Improvements final rule, a
healthcare facility must keep any
information used to support its
hazardous waste determination for at
least three years from the date the waste
was last sent to on-site or off-site
treatment, storage or disposal, unless it
chooses to manage all of its non-
creditable pharmaceutical waste as
hazardous waste under subpart P. The
periods of retention will be
automatically extended in the event of
any enforcement activity or as requested
by the Regional Administrator.
L. Response to Spills for Healthcare
Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals
(§
266.502(k))
1. Summary of Proposal
For non-creditable hazardous waste
pharmaceuticals generated and managed
by healthcare facilities under this
subpart, the Agency proposed basic spill
response requirements, including the
requirement that healthcare facilities
immediately contain all spills of, and
other residues from, hazardous waste
pharmaceuticals. In addition, we
proposed that healthcare facilities
determine whether any material (e.g.,
residue, contaminated clean-up
materials, or debris resulting from the
spill) is or contains a hazardous waste
pharmaceutical and, if so, that the
healthcare facility manage it under the
management standards for non-
creditable hazardous waste
pharmaceuticals. Commenters to the
original 1993 proposed rulemaking for
establishing the Universal Waste
program overwhelmingly supported
these release response measures (60 FR
25528; May 11, 1995). Thus, we believe
it was appropriate to include them again
in this proposal for healthcare facilities
managing non-creditable hazardous
waste pharmaceuticals since it was
based on the Universal Waste program.
2. Summary of Comments
One waste management company was
in support of the proposed standards
while another voiced its concern with
the proposed preamble language
discussing the requirement to report
releases into the environment greater
than the reportable quantity without
knowing the waste codes of the wastes
that had been spilled. They
recommended that the Agency establish
a reportable quantity for hazardous
waste pharmaceuticals so large releases
are appropriately reported to EPA.
Similarly, one pharmacist trade
association recommended that the
Agency define what constitutes a release
because the proposed regulatory
language and preamble are unclear, and
therefore it is also unclear when a
release needs to be reported to the
Agency.
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225
Spills are likely to occur upon impermeable
surfaces both inside of and outside of a healthcare
facility which limits the potential for release into
the environment. Under CERCLA, a release to the
environment also includes releases into the
atmosphere. Since many pharmaceuticals are in pill
form, spilled pharmaceuticals would rarely,
constitute a release to the environment under
CERCLA.
One state commenter pointed out that
these standards should also apply to
healthcare facilities that accumulate
potentially creditable hazardous waste
pharmaceuticals. They recommend that
this standard apply to all hazardous
waste pharmaceuticals and that after a
spill is cleaned up, the determination of
credit potential must be made again. All
other states agreed with the proposed
standards for responding to spills.
3. Final Rule Provisions
The standards in this subsection are
being substantially finalized as
proposed with two changes.
First, we changed the word ''release''
to ''spill'' in the regulations in response
to a commenter that expressed concern
about having to comply with CERCLA
requirements for spills of non-creditable
hazardous waste pharmaceuticals. It
was not the Agency's intent to imply
that spills occurring inside a healthcare
facility are automatically subject to
CERCLA. The proposed preamble
language was intended to differentiate
between three scenarios: Spills that are
cleaned up immediately, spills that are
not cleaned up immediately, and
releases to the environment. Spills that
are cleaned up immediately must be
managed under this subpart. Spills that
are not cleaned up immediately would
generally constitute illegal disposal,
which may result in further action by
EPA or an authorized state. The
proposal also mentioned that hazardous
waste is included in the definition of
hazardous substance under CERCLA,
and any release to the environment
would trigger CERCLA authority in
addition to RCRA. In many cases, a spill
of a hazardous waste pharmaceuticals
that occurs inside a healthcare facility
does not constitute a release to the
environment under CERCLA.
225
Therefore, this standard applies to spills
that do not constitute a release to the
environment, and there are no reporting
requirements for spills unless they
result in a release to the environment.
This requirement makes no assertions
about when or how CERCLA applies to
spills of both non-creditable hazardous
waste pharmaceuticals and potentially
creditable hazardous waste
pharmaceuticals. The new terminology
is also consistent with the term used in
the definition of non-creditable
hazardous waste pharmaceuticals in
§
266.500, which refers to spills as
opposed to releases.
Second, we addressed the comment
from the state that requested a
clarification regarding whether the spill
response requirements apply to
potentially creditable hazardous waste
pharmaceuticals and non-creditable
hazardous waste pharmaceuticals. The
Agency agrees that the applicability of
this proposed provision-whether it
applies only to non-creditable
hazardous waste pharmaceuticals or to
both potentially creditable hazardous
waste pharmaceuticals and non-
creditable hazardous waste
pharmaceuticals-was unclear. The
regulatory language has been changed to
reflect that the standards in this
subsection apply only to spilled non-
creditable hazardous waste
pharmaceuticals. Further, the proposed
regulations required that a healthcare
facility determine whether, after being
cleaned up, spilled non-creditable
hazardous waste pharmaceuticals are
potentially creditable or non-creditable,
implying that non-creditable hazardous
waste pharmaceuticals could become
potentially creditable. The Agency did
not intend to imply that spilled non-
creditable hazardous waste
pharmaceuticals could become
potentially creditable. The regulatory
language has been modified to simply
require that spilled non-creditable
hazardous waste pharmaceuticals and
clean-up material be contained and
managed as non-creditable hazardous
waste pharmaceuticals. To address this
regulatory gap that commenters
identified regarding spilled potentially
creditable hazardous waste
pharmaceuticals, the Agency has added
a corresponding subsection containing
standards for response to spills of
potentially creditable hazardous waste
pharmaceuticals at a healthcare facility
to the regulatory language at
§
266.503(f).
M. Management of Non-Creditable
Hazardous Waste Pharmaceuticals by
Long-Term Care Facilities That Collect
Them From Individuals Who Self-
Administer
1. Summary of Proposal
The Agency proposed that a LTCF
must collect hazardous waste
pharmaceuticals from its residents that
self-administer their medication and
manage them under this subpart. This
provision was proposed in order to
require the proper management of all
hazardous waste pharmaceuticals at
LTCFs. LTCFs are similar to hospitals in
that they are both healthcare providers,
but they differ with respect to who owns
the pharmaceuticals dispensed to
patients. While hospitals own the
pharmaceuticals they dispense, the
pharmaceuticals dispensed at long-term
care facilities belong to the residents of
the facility. EPA understands that, while
long-term care facilities often maintain
each individual's pharmaceuticals in a
centralized location, such as a
pharmaceutical cart, there are instances
where some individuals at some types
of LTCFs may keep and self-administer
their own pharmaceuticals. Under the
proposal, long-term care facilities would
have had to collect and manage all
hazardous waste pharmaceuticals
generated on site, regardless of
ownership, in accordance with these
same proposed subpart P management
standards for healthcare facilities. EPA
believed this approach would prohibit
and prevent sewering of hazardous
waste pharmaceuticals at these
locations.
2. Summary of Comments
There was very little agreement with
the proposed requirement for LTCFs to
collect hazardous waste
pharmaceuticals from patients that self-
administer their medication. Most
commenters argued that hazardous
waste pharmaceuticals generated by
residents who self-administer are
household hazardous waste and that
LTCFs are not allowed by law to
perform any mandatory collection
actions and have no authority to compel
residents to surrender their unused
medications. In addition, they
commented that medication prescribed
under Medicare Subpart D is considered
the property of the resident. One
commenter also pointed out that this
provision would be unlawful and even
dangerous to enforce because it would
entail inspectors having to enter private
residences, which is prohibited by many
state statutes, and search through
garbage bags and dumpsters to ensure
that hazardous waste pharmaceuticals
have not been illegally disposed.
Also, one commenter mentioned that
this provision would add significant
cost to the residents because waste
management expenses are not covered
under Medicare and pharmacies are not
allowed to offer waste collection
services for less than cost and would
therefore be required to pass the full
cost onto the residents.
3. Final Rule Provisions
The Agency is not finalizing the
proposed provisions in this subsection.
As discussed previously, after
consideration of the comments, the
Agency modified the definition of LTCF
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The Hazardous Waste Generator
Improvements final rule renamed CESGGs as
VSQGs, moved the regulations from §
261.5 to
§
262.14 and added an eighth type of facility.
227
40 CFR 262.14(a)(5)(viii).
228
Person means an individual, trust, firm, joint
stock company, Federal Agency, corporation
(including a government corporation), partnership,
association, State, municipality, commission,
political subdivision of a State, or any interstate
body.
229
For purposes of this provision, ''control''
means the power to direct the policies of the
healthcare facility, whether by the ownership of
stock, voting rights, or otherwise, except that
contractors who operate facilities on behalf of a
different person shall not be deemed to control such
healthcare facility.
230
See notes from 11-28-12 meeting with U.S.
Army Institute of Public Health in the docket for
this rule (EPA-HQ-RCRA-2007-0932-0209).
231
For purposes of this provision, ''control''
means the power to direct the policies of the
healthcare facility, whether by the ownership of
stock, voting rights, or otherwise, except that
contractors who operate facilities on behalf of a
different person shall not be deemed to control such
healthcare facility.
to specifically exclude assisted living
facilities, group homes, independent
living communities, and the
independent/assisted living portions of
continuing care retirement
communities. The Agency agrees that
the hazardous waste pharmaceuticals
generated at these types of facilities
meet the criteria for the household
hazardous waste exclusion in
§
261.4(b)(1) and are therefore not under
the purview of RCRA regulations.
Accordingly, we have also deleted
proposed §
266.502(l) and the final rule
does not require LTCFs to collect
hazardous waste pharmaceuticals for
their residents that have custody of and
self-administer their medication. The
Agency does, however, reiterate that
this definition of LTCFs classified them
as a type of healthcare facility. As such,
LTCFs are subject to all the provisions
being finalized for hazardous waste
pharmaceuticals that are present in an
LTCF's central pharmacy, because the
hazardous waste being generated is not
the property of the residents.
Additionally, hazardous waste
pharmaceuticals that are in the custody
of the LTCF on behalf of the resident
must be managed under this subpart.
That said, the Agency expects that most
LTCFs will be VSQGs and therefore
only subject to a limited subset of the
regulations in this rule, including the
sewer prohibition of §
266.505, the
empty container standards of §
266.507,
and the optional provisions of
§
266.504. In fact, §
266.504(d) of the
final rule includes a presumption that
an LTCF with fewer than 20 beds is a
VSQG.
Although not regulated under this
subpart, the Agency recommends that
assisted living facilities, group homes,
independent living communities, and
the independent and assisted living
portions of continuing care retirement
communities develop voluntary
pharmaceutical collection programs for
both hazardous and non-hazardous
waste pharmaceuticals as a best
management practice, as allowed by
DEA regulations, to ensure proper
management, avoid flushing, and
minimize the potential for accidental
poisonings, misuse or abuse.
N. Healthcare Facilities That Accept
Hazardous Waste Pharmaceuticals
From Off-Site Very Small Quantity
Generator Healthcare Facilities
(§
266.502(l))
1. Summary of Proposal
Typically, hazardous waste
pharmaceuticals from healthcare
facilities are transported either to a
reverse distributor, if it is potentially
creditable, or to a permitted or interim
status hazardous waste TSDF, if it is
not. However, stakeholders have
informed EPA that in some cases,
hazardous waste pharmaceuticals are
transported to another healthcare
facility.
Until EPA finalized the Hazardous
Waste Generator Improvements rule on
November 28, 2016, CESQG regulations
of §
261.5 did not allow a generator to
send its hazardous waste off site to
another generator, unless the receiving
generator was one of the seven types of
facilities listed in §
261.5(f)(3)(i)-(vii) or
§
261.5(g)(i)-(vii), which included
landfills permitted by state law.
226
The
2016 Hazardous Waste Generator
Improvements final rule added a new
provision for the consolidation of
hazardous waste from VSQGs to LQGs
under the control of the same person.
227
Person is defined under RCRA in
§
260.10 and control is defined as ''the
power to direct policies at the facility
under RCRA in §
260.10.''
228
229
This
provision now allows the same
company to consolidate its VSQG
hazardous waste at its LQG sites.
Specific to healthcare facilities, EPA
is aware of two situations in which
VSQGs would like to consolidate their
hazardous waste pharmaceuticals at
other healthcare facilities. The first
situation is LTCFs that are VSQGs that
return their hazardous waste
pharmaceuticals to long-term care
pharmacies that they contract with. The
second situation involves military bases,
where the off-post clinics that are
generally VSQGs would like to send
their hazardous waste pharmaceuticals
back to the base clinics or pharmacies
on the nearby base.
230
Since long-term care pharmacies are
not generally under the control of the
same person as the LTCF, the proposed
healthcare facility consolidation
provision was broader than what was
finalized in the 2016 Hazardous Waste
Generator Improvements rule to
accommodate the contractual
relationship between long-term care
facilities and long-term care pharmacies.
The Agency proposed this consolidation
provision to allow healthcare facilities
that are VSQGs to send their hazardous
waste pharmaceuticals to another
healthcare facility rather than send it to
a municipal solid waste landfill.
Specifically, EPA proposed to allow
VSQG healthcare facilities to send their
hazardous waste pharmaceuticals to an
off-site healthcare facility without a
hazardous waste manifest, provided the
receiving healthcare facility meets four
conditions. First, the receiving
healthcare facility must be contracted to
supply pharmaceutical products to the
VSQG LTCF, or the VSQG healthcare
facility and the receiving healthcare
facility must both be under the control
of the same person, as defined by
§
260.10.
231
Second, the receiving
healthcare facility must be managing its
hazardous waste pharmaceuticals in
accordance with subpart P. Third, the
hazardous waste pharmaceuticals from
the VSQG must be managed by the
receiving healthcare facility as
hazardous waste pharmaceuticals in
accordance with subpart P once it
arrives at the receiving healthcare
facility. Fourth, the receiving healthcare
facility must keep and maintain records
of the hazardous waste pharmaceuticals
received from the off-site VSQG
healthcare facilities for three years from
receipt of shipment.
As proposed, these conditions would
ensure the proper management of the
hazardous waste pharmaceuticals: Once
they are received by the healthcare
facility, they are subject to the same
management standards EPA proposed
for hazardous waste pharmaceuticals
managed by healthcare facilities.
EPA took comment on two aspects of
this exclusion: (1) Whether any
additional conditions should be
imposed in this provision and (2)
whether to expand the scope of the
provision to facilities that do not meet
the proposed definition of a healthcare
facility in this rule.
2. Summary of Comments
Overall, states, waste management
and the healthcare industry were
supportive of the proposal to allow
VSQG healthcare facilities to
consolidate their hazardous waste
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232
As allowed by 40 CFR 266.504(a).
233
https://www.cms.gov/Regulations-and-
Guidance/Regulations-and-Guidance.html.
234
https://www.cms.gov/Regulations-and-
Guidance/Regulations-and-Guidance.html.
pharmaceuticals at another healthcare
facility, provided the four conditions
outlined above are met. One state,
however, did oppose this provision
unless the receiving healthcare facility
is subject to all of the LQG requirements
under part 262. They recommended that
hazardous waste pharmaceuticals from
VSQGs be consolidated at larger
healthcare facilities under the 2016
Hazardous Waste Generator
Improvements final rule to ensure more
stringent standards are met by the
receiving facility. Some states and
pharmacists raised concerns that some
of the language within the conditions
was too narrow to serve the purpose that
the language was trying to achieve.
3. Final Rule Provision
EPA is finalizing the provision to
allow healthcare facilities that are
operating under subpart P to receive
hazardous waste pharmaceuticals from
VSQGs with minor changes. Healthcare
facilities that are VSQGs for their
pharmaceutical and non-pharmaceutical
waste may send their potentially
creditable and non-creditable hazardous
waste pharmaceuticals to an off-site
healthcare facility operating under
subpart P, without a hazardous waste
manifest, provided the receiving
healthcare facility meets the four
conditions in §
266.502(l)(1)-(4) or
§
266.503(b)(1)-(4), as applicable.
Several conforming changes were
made to reflect the change in
terminology from CESQG to VSQG and
to reflect the reorganization of the VSQG
regulations from §
261.5 to §
262.14.
There are three more substantive
changes from the proposal. First, under
§
266.502(l)(1) where we proposed that
one way a healthcare facility could
receive hazardous waste
pharmaceuticals from an off-site VSQG
healthcare facility was to have a
contractual relationship to provide the
pharmaceutical products to the LTCF,
we broadened the language to allow
cases in which a ''business
relationship'' between the LTCF and
long-term care pharmacy exists.
Under the final rule, a healthcare
facility under subpart P may accept non-
creditable hazardous waste
pharmaceuticals from an off-site
healthcare facility that is a VSQG under
§
262.14, without a permit or without
having interim status, provided the
receiving healthcare facility:
(1) Is under the control of the same
person, as defined in §
260.10, as the
VSQG healthcare facility that is sending
the non-creditable hazardous waste
pharmaceuticals off site, or has a
contractual or other documented
business relationship whereby the
receiving healthcare facility supplies
pharmaceuticals to the VSQG healthcare
facility;
(2) Is operating under subpart P for
the management of its non-creditable
hazardous waste pharmaceuticals;
(3) Manages the non-creditable
hazardous waste pharmaceuticals that it
receives from off site in compliance
with subpart P; and
(4) Keeps records of the non-
creditable hazardous waste
pharmaceuticals shipments it receives
from off site for three years from the
date that the shipment is received.
It is important to note that a VSQG
healthcare facility that chooses to send
their waste for consolidation to an off-
site healthcare facility is not considered
to be operating under subpart P and
does not need to notify as a VSQG
operating under subpart P.
The second substantive change was to
include a parallel provision in §
266.503
for potentially creditable hazardous
waste pharmaceuticals. This addition
allows healthcare facilities that are
VSGQs two options for where to send
their potentially creditable hazardous
waste pharmaceuticals. The first option
is to send them directly to a reverse
distributor.
232
The second option is to
send them to a healthcare facility
operating under part 266 subpart P,
provided the receiving facility meets the
conditions of 266.503(b)(1)-(4).
The third change related to off-site
consolidation of hazardous waste
pharmaceuticals is to add paragraph
§
262.14(a)(5)(x). Section 262.14(a)(5) of
the VSQG regulations consists of a list
of types of facilities to which VSQGs
can send their hazardous waste. Section
262.14(a)(5)(viii) allows VSQGs to send
their hazardous waste to large quantity
generators under the control of the same
person as the VSQG, provided certain
conditions are met. This provision is
similar to the provision we are
finalizing in this rule for healthcare
facilities that are VSQGs. Therefore, for
consistency, we have added paragraph
(x) to the list of facilities in
§
262.14(a)(5) such that a healthcare
facility that is a VSQG can send its non-
creditable hazardous waste
pharmaceuticals and potentially
creditable hazardous waste
pharmaceuticals to an off-site healthcare
facility (as defined in §
266.500) that
meets the conditions in §
266.502(l) and
§
266.503(b), as applicable.
4. Comments and Responses
Some states and pharmacists noted
that language in the first condition may
have the unintended consequence of
prohibiting healthcare facilities from
consolidating their hazardous waste
pharmaceuticals due to their
relationship with the consolidating
facility. The first condition that a
receiving healthcare facility must be
under the control of the same person or
contracted to supply pharmaceutical
products to the VSQG's LTCF might
prevent some long-term care facilities
from taking advantage of this provision.
Long-term care facilities that would
otherwise be eligible to take advantage
of this exclusion might not use it since
CMS does not prevent long-term care
facilities and/or their residents from
using more than one long-term care
pharmacy. This allows the long-term
care facilities and the residents to shop
for the ''best and most competitive''
pricing for medications and to change as
needed.
233
Commenters believed that
adding ''business relationship'' in
addition to a contractual relationship for
the healthcare facility and receiving
facility to both be under the control of
the same person would relieve this
concern.
Furthermore, pharmacists raised the
concern that a long-term care pharmacy
would not want to take responsibility
for returned pharmaceuticals under this
condition as proposed unless they could
confirm that they were the ones that
distributed the pharmaceuticals in the
first place (a receipt of purchase or
similar documentation), since the
management of these wastes is costly
and may not be covered by the various
healthcare programs. According to the
CMS website, the managing of returned
pharmaceuticals at long-term care
pharmacies varies from state to state and
is not a specific requirement of the
Medicare/Medicaid program.
234
This
consolidation provision was created so
that VSQGs could consolidate their
hazardous waste pharmaceuticals for
proper management. If the provision as
written is preventing long-term care
facilities from potentially consolidating
their hazardous waste, then it is
thwarting the intended outcome of this
provision and that is why EPA decided
to add ''business relationship'' to the
first condition for VSQG consolidation.
One state commenter recommended
that the receiving healthcare facilities
must either be an LQG or comply with
the LQG requirements under part 262,
since LQGs have more protective
management standards during
accumulation. First, under part 266
subpart P, healthcare facilities do not
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have a generator category for their
hazardous waste pharmaceuticals; all
healthcare facilities are regulated the
same under part 266 subpart P. Second,
if EPA limited this consolidation
provision to LQGs, then there would be
a very small subset of receiving
healthcare facilities that would be able
to take advantage of this provision.
Since subpart P allows healthcare
facilities operating under this subpart to
not count their hazardous waste
pharmaceuticals towards their generator
category, some healthcare facilities may
no longer be LQGs for their other
hazardous waste. It is highly unlikely
that a long-term care pharmacy would
remain an LQG under this rule since the
majority of the hazardous waste that
would be handled at these pharmacies
would be pharmaceuticals. If we were to
limit this provision to only LQG
receiving facilities, then we would be
preventing LTCFs from consolidating at
long-term care pharmacies. Therefore,
we determined that requiring the
receiving facilities to be LQGs or to
comply with LQG standards as a
condition of the consolidation provision
would severely limit the value of this
provision.
In addition, the Agency is not
finalizing a requirement for healthcare
facilities that receive hazardous waste
pharmaceuticals from VSQG healthcare
facilities to manage the received
pharmaceutical waste under the part
262 LQG standards. The Agency does
not see the necessity in having more
stringent management standards for
healthcare facilities that receive
pharmaceutical waste, because subpart
P management standards are the same
for all non-VSQG healthcare facilities,
regardless of the amount of hazardous
waste pharmaceuticals they generate.
The Agency has determined that the
subpart P standards are sufficiently
protective of human health and the
environment since all pharmaceuticals
at a receiving healthcare facility must be
managed under the same subpart P
standards, regardless of whether they
were generated on site or received from
off site. If a state determines that the
standards being finalized for healthcare
facilities that receive hazardous waste
pharmaceuticals from off-site are not
adequate, that state may implement its
own standards, provided they are more
stringent.
The waste management industry, as
well as some states, recommended that
EPA require a notification when a
facility was receiving hazardous waste
pharmaceuticals and at least some
minimal requirements for labeling,
recordkeeping, and documentation of
shipments. One state also recommended
that we issue licenses to facilities that
were receiving hazardous waste
pharmaceuticals in order to track who
was taking advantage of this provision.
Consistent with our rationale for the
limited shipping requirements for
''potentially creditable hazardous waste
pharmaceuticals'' in this rule, the
Agency believes that the shipping of
hazardous waste pharmaceuticals poses
a relatively low risk of release to the
environment but a high risk for
diversion of the pharmaceuticals when
labeled ''pharmaceuticals.'' The
hazardous waste that are being shipped
often are in pill form or blister packs
and not fifty-gallon drums of liquids
that can be easily spilled. They are not
likely to pose the same risks that typical
hazardous waste could cause during
shipping and transport, but there is a
real risk to them being stolen if attention
is brought to the contents of the
containers. If the four conditions are
met, the Agency believes this ensures
the proper management of hazardous
waste pharmaceuticals and adding new
labeling and shipping requirements is
unnecessary to accomplish that goal.
Furthermore, the part 262 VSQG
regulations do not require labeling or
recordkeeping, and VSQGs might not
take advantage of this consolidation
provision if the requirements are too
onerous, thus continuing to put their
hazardous waste pharmaceuticals in
municipal solid waste landfills.
The waste management industry
asked for clarification on hazardous
waste pharmaceuticals consolidation
across state lines that have different
requirements for VSQGs. There is
nothing in this section that prevents a
healthcare facility from sending their
hazardous waste pharmaceuticals to a
healthcare facility in another state
provided both states have adopted this
provision. Each state has their own
requirements, so it would be prudent for
VSQG healthcare facilities to make sure
that the state in which they are
consolidating has adopted this
provision and does not impose any
additional requirements on the
receiving healthcare facility that accepts
this waste.
EPA also received comments on what
types of facilities could take advantage
of this provision, specifically whether
this provision will include wholesale
drug distribution centers. In the final
rule, EPA has defined wholesale
distributors as a type of healthcare
facility under §
266.500. Wholesale
distributors were not an example that
was given to us at proposal for this
consolidation provision, but if all four
conditions were met and there was a
contractual or business relationship
between the VSQG healthcare facility
and the wholesale distributor, they
would not be precluded from using this
provision. However, we would note that
when a wholesale distributor receives
hazardous waste pharmaceutical return
from a healthcare facility, the
pharmaceuticals are usually restocked,
which means they are pharmaceutical
products and not hazardous waste
pharmaceuticals.
Lastly, a non-profit organization asked
us to clarify if these consolidated
hazardous waste pharmaceuticals would
be eligible for redistribution or
evaluation for donation once
consolidated to the receiving facility. In
regard to redistribution or evaluation for
donation, if the receiving healthcare
facility can lawfully donate or
redistribute the consolidated hazardous
waste pharmaceuticals, there is nothing
in this provision that prevents that from
occurring, but those shipments would
not fall under the consolidation
provision in subpart P. If a VSQG is
sending products to another facility,
then the receiving facility should
evaluate the received pharmaceuticals
as they would any other products they
receive for continued use, redistribution
to secondary markets, donation and/or
any other lawful possibilities. At this
point, they are not a solid or hazardous
waste and not subject to the
requirements in §
266.502(l) or
§
266.503(b).
EPA would also note that this
provision is optional and it is not meant
to impose undue burden on healthcare
facilities. This section does not require
a VSQG healthcare facility to ship their
hazardous waste pharmaceuticals to a
receiving healthcare facility. VSQG
healthcare facilities continue to have the
option, unless the state regulations are
more stringent, of sending their
hazardous waste pharmaceuticals to any
of the types of facilities specified in
§
262.14, including a municipal solid
waste landfill.
XI. Standards for Healthcare Facilities
That Accumulate Potentially Creditable
Hazardous Waste Pharmaceuticals
Prior to Shipment to Reverse
Distributors (§
266.503)
A. Healthcare Facilities Making a
Hazardous Waste Determination for
Potentially Creditable Pharmaceuticals
(§
266.503(a))
1. Summary of Proposal
EPA proposed standards for
healthcare facilities managing
potentially creditable hazardous waste
pharmaceuticals in §
266.503 of subpart
P. As with non-creditable hazardous
waste pharmaceuticals, a healthcare
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facility must determine which
potentially creditable pharmaceuticals
are listed or characteristic hazardous
wastes, in order to determine which
potentially creditable pharmaceuticals
are subject to regulation under this
subpart.
Accordingly, we proposed that a
healthcare facility that generates a solid
waste that is a potentially creditable
pharmaceutical must determine whether
the potentially creditable solid waste
pharmaceutical is a potentially
creditable hazardous waste
pharmaceutical (i.e., is listed in 40 CFR
part 261 subpart D or exhibits a
characteristic identified in 40 CFR part
261 subpart C).
We also proposed that a healthcare
facility may choose to manage all of its
potentially creditable waste
pharmaceuticals (both hazardous and
non-hazardous) together as potentially
creditable hazardous waste
pharmaceuticals while accumulating on
site and when shipping off site under
§
266.509. If a healthcare facility
chooses this approach of commingling
its hazardous and non-hazardous
potentially creditable waste
pharmaceuticals, it would not need to
make individual hazardous waste
determinations, but would have made a
generic decision that all of its
potentially creditable waste
pharmaceuticals are hazardous and
would manage them as potentially
creditable hazardous waste
pharmaceuticals in accordance with the
requirements in 40 CFR part 266
subpart P.
We proposed that healthcare facilities
may choose to manage potentially
creditable non-hazardous waste
pharmaceuticals as potentially
creditable hazardous waste
pharmaceuticals under the shipping
standards of §
266.509. Additionally,
EPA proposed that healthcare facilities
would be prohibited from sending
hazardous waste other than potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor.
This was in keeping with our position
that a reverse distributor's function in
managing hazardous waste should be
limited to managing hazardous waste
pharmaceuticals that have a reasonable
expectation of receiving manufacturer
credit and not non-creditable hazardous
waste pharmaceuticals or other non-
pharmaceutical hazardous waste.
2. Summary of Comments
Pharmacists, some wholesalers, and
manufacturers expressed concern that
making hazardous waste determinations
at their facilities would require
additional staff, additional training on
making hazardous waste determination,
as well as more storage space in which
to hold the hazardous waste as the
determinations are being made.
We received mixed comments on
commingling potentially creditable non-
hazardous and hazardous waste
pharmaceuticals. Healthcare facilities
and pharmacists were in favor of EPA
allowing commingling potentially
creditable non-hazardous and hazardous
waste pharmaceuticals, and the benefit
it offers in handling their
pharmaceutical waste or continuing the
common practice of commingling
potentially creditable non-hazardous
and hazardous waste pharmaceuticals
when sent to reverse distributors. On
the other hand, waste management and
states raised concerns that commingling
potentially creditable non-hazardous
and hazardous waste pharmaceuticals
may prevent healthcare facilities from
sending their waste across state lines or
to certain reverse distributors, due to
state regulations and/or reverse
distributors' policies.
3. Final Rule Provisions
EPA is finalizing the standards as
proposed, with some minor changes.
Under this section, a healthcare facility
has two choices: (1) Make a hazardous
waste determination on each potentially
creditable waste pharmaceutical and
determine individually which are
hazardous waste and thus subject to
regulation under this subpart or, (2)
commingle all potentially creditable
pharmaceutical waste whether or not it
is hazardous waste and manage the
commingled pharmaceuticals under this
subpart and thereby not have to make
individual hazardous waste
determinations.
EPA removed ''even if the solid waste
pharmaceuticals do not exhibit a
characteristic identified in 40 CFR part
261 subpart C and are not listed in 40
CFR part 261 subpart D'' from the non-
hazardous waste provision of this
section since it was redundant with
determinations of solid waste
pharmaceuticals and whether they are
potentially creditable or not.
EPA has also modified the regulatory
language in the final rule to make clear
that when a healthcare facility
commingles potentially creditable non-
hazardous and hazardous waste
pharmaceuticals, the healthcare facility
is choosing to subject the potentially
creditable non-hazardous waste
pharmaceuticals to all of subpart P
while being managed at a healthcare
facility and in preparation for shipping
off-site. Once potentially creditable non-
hazardous and hazardous waste
pharmaceuticals are commingled they
are subject to all applicable subpart P
management standards while they
remain commingled. As a practical
matter, however, we expect that the
primary impact to healthcare facilities
will be that potentially creditable non-
hazardous waste pharmaceuticals are
subject to the shipping standards of
§
266.509. Once potentially creditable
non-hazardous waste pharmaceuticals
are shipped off site to a reverse
distributor, a reverse distributor may
choose to segregate the non-hazardous
waste pharmaceuticals from the
hazardous waste pharmaceuticals. This
process of segregation by the reverse
distributor would require the reverse
distributor to make new hazardous
waste determinations on the
commingled pharmaceuticals.
4. Comments and Responses
We received many comments on
making hazardous waste determinations
and commingling potentially creditable
non-hazardous and hazardous waste
pharmaceuticals. While the commenters
raised valid concerns on why making
hazardous waste determinations can be
burdensome on a healthcare facility, or
why commingling potentially creditable
non-hazardous and hazardous waste
pharmaceuticals may not work for all
facilities, EPA made only minor
editorial changes to this section of the
final rule. The Agency determined that
more substantive changes were
unnecessary because this provision
contains sufficient flexibility by
providing healthcare facilities with two
options.
a. Making hazardous waste
determinations. Pharmacists, some
wholesalers, and manufacturers
expressed concern that being required to
make hazardous waste determinations at
their facilities would impose undue
burden because they would have to hire
additional staff and train them to make
accurate waste determination. They
argue that they would also need to
allocate more space in which to store
waste as the determinations are being
made. Some commenters stated that
making hazardous waste determinations
may prevent healthcare facilities from
sending their hazardous waste
pharmaceuticals to reverse distributors
at all. In support of the comments
above, manufacturers and wholesalers
argued that reverse distributors have the
appropriate RCRA expertise to make
accurate waste determinations, that they
have served as a consolidation point for
unused and hazardous waste
pharmaceuticals for many years, and
that the process has been effective and
successful. The Agency notes, however,
that allowing potentially creditable
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235
This provision is now found at §
266.502(l).
pharmaceuticals to be sent to a reverse
distributor without a hazardous waste
determination being made at the point
of generation violates a basic tenet of
RCRA, because the decision to send
them to a reverse distributor is
effectively a decision to discard. In
addition, the burden mentioned by
commenters associated with making
individual waste determinations would
likely be significantly mitigated by
exercising the option to manage all
potentially creditable waste
pharmaceuticals as potentially
creditable hazardous waste
pharmaceuticals.
b. Commingled waste stream. As
previously noted, we received mixed
comments on commingling potentially
creditable non-hazardous hazardous
waste pharmaceuticals.
EPA proposed the option of
commingling potentially creditable non-
hazardous and hazardous waste
pharmaceuticals to mitigate the burden
of complying with the management
standards, particularly for healthcare
personnel making hazardous waste
determinations. Given that many
healthcare facilities currently
commingle their potentially creditable
non-hazardous and hazardous waste
pharmaceuticals, we expect the practice
to continue. However, if commingling
causes undue burden on a facility due
to state regulations, reverse distributor
policies, or other reasons, then the
healthcare facility does not have to
utilize this option and can make
individual hazardous waste
determinations in accordance with
§
266.503(a). This is an individual
decision for each healthcare facility and
each healthcare facility may choose
what works best for managing its
potentially creditable pharmaceutical
waste.
Retailers and reverse distributors
recommended that healthcare facilities
should be allowed to make a
determination about whether the item
will be managed as hazardous when it
becomes a waste at the time of arrival
at the retail store or healthcare facility.
They believe this practice would be
impeded if all pharmaceuticals must be
managed as potentially creditable
hazardous waste pharmaceuticals when
they become waste. If this is common
practice among healthcare facilities,
then the need to commingle their waste
may not be something that is important.
Allowing the commingling of all solid
waste pharmaceuticals is meant to ease
the burden on healthcare facilities that
are not currently making hazardous
waste determinations, or do not wish to
make them, by allowing them to manage
and ship all of their potentially
creditable waste pharmaceuticals
together.
B. Accepting Potentially Creditable
Hazardous Waste Pharmaceuticals
From an Off-Site Healthcare Facility
That Is a Very Small Quantity Generator
(§
266.503(b))
1. Summary of Proposal
EPA proposed to allow healthcare
facilities operating under subpart P to
accept potentially creditable and non-
creditable hazardous waste
pharmaceuticals from an off-site VSQG
healthcare facility without a hazardous
waste manifest, provided four
conditions are met. We proposed this
provision in §
266.502(m) under the
standards for managing non-creditable
hazardous waste pharmaceuticals.
235
We proposed that healthcare facilities
operating under subpart P could accept
both potentially creditable and non-
creditable hazardous waste
pharmaceuticals from an off-site
healthcare facility that is a VSQG.
Previously, the part 262 VSQG
regulations did not allow a healthcare
facility to send its hazardous waste off-
site to another healthcare facility, unless
the receiving healthcare facility is one of
the eight types of facilities listed in
§
262.14(a)(5)(i-viii). For more detailed
information on our proposal, please
refer to section X.N.
2. Summary of Comments
EPA only received one comment in
this section concerning changes to the
generator category of the receiving
facility. A trade association of
pharmacists was concerned that
allowing VSQG consolidation would
affect the generator category of the
receiving healthcare facility, and that it
would need to report as an LQG.
3. Final Rule Provision
In the proposed rulemaking, EPA
intended to allow healthcare facilities to
accept both potentially creditable and
non-creditable (including commingled)
hazardous waste pharmaceuticals from
an off-site VSQG healthcare facility,
provided the receiving healthcare
facility complies with the four
conditions of §
266.502(m) (now in
§
266.502(l)). In the final rule, we
clarified our intention to allow
healthcare facilities to accept both
potentially creditable and non-
creditable (including commingled)
hazardous waste pharmaceuticals from
an off-site VSQG healthcare facility by
placing similar standards in §
266.503(b)
under the standards for managing
potentially creditable hazardous waste
pharmaceuticals. This does not reflect a
change from what was proposed, only
that the consolidation standards apply
to healthcare facilities receiving both
non-creditable and potentially
creditable hazardous waste
pharmaceuticals.
Under the final rule, a healthcare
facility that is a VSQG can send both its
potentially creditable hazardous waste
pharmaceuticals and non-creditable
(including commingled) hazardous
waste pharmaceuticals to an off-site
healthcare facility operating under
subpart P, provided the receiving
healthcare facility complies with the
four requirements of the respective
sections. Regulations for the receiving
healthcare facilities now appear in
§
266.502(l) for non-creditable
hazardous waste pharmaceuticals and in
§
266.503(b) for potentially creditable
hazardous waste pharmaceuticals.
VSQG healthcare facilities that send
their hazardous waste pharmaceuticals
to an off-site healthcare facility are
subject to the regulations in
§
266.504(b), with further discussion in
section XII.B of the preamble.
Under §
266.503(b) of the final rule, a
healthcare facility may accept
potentially creditable hazardous waste
pharmaceuticals from an off-site
healthcare facility that is a VSQG under
§
262.14, without a permit or without
having interim status, provided the
receiving healthcare facility:
(1) Is under the control of the same
person, as defined in §
260.10, as the
VSQG healthcare facility that is sending
potentially creditable hazardous waste
pharmaceuticals off site, or has a
contractual or other documented
business relationship whereby the
receiving healthcare facility supplies
pharmaceuticals to the VSQG healthcare
facility;
(2) Is operating under subpart P for
the management of its potentially
creditable hazardous waste
pharmaceuticals;
(3) Manages the potentially creditable
hazardous waste pharmaceuticals that it
receives from off site in compliance
with subpart P; and
(4) Keeps records of the potentially
creditable hazardous waste
pharmaceuticals shipments it receives
from off site for three years from the
date that the shipment is received.
It is important to note that a VSQG
healthcare facility that chooses to
consolidate its hazardous waste
pharmaceuticals at an off-site healthcare
facility is not considered to be operating
under subpart P, and does not need to
notify as a VSQG operating under
subpart P.
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See 73 FR 73529; December 2, 2008.
4. Comments and Responses
A pharmacists' association was
concerned that allowing for VSQG
consolidation would change the
generator category of the receiving
healthcare facilities and that the
consolidating facility would need to
report as an LQG. All healthcare
facilities operating under part 266
subpart P are regulated the same,
regardless of the amount of hazardous
waste pharmaceuticals they generate.
Further, healthcare facilities managing
their hazardous waste pharmaceuticals
under this subpart do not count their
hazardous waste pharmaceuticals
toward their generator category so
consolidation of this additional
hazardous waste pharmaceuticals at
their facilities would not change the
generator category of the receiving
healthcare facility.
C. Accumulation Time, Container
Management and Labeling for
Healthcare Facilities Managing
Potentially Creditable Hazardous Waste
Pharmaceuticals
Under the hazardous waste generator
regulations in part 262, EPA requires
specific management standards for
containers that hold hazardous waste.
However, potentially creditable
hazardous waste pharmaceuticals pose a
lower risk of release into the
environment than traditional industrial
hazardous waste. The risk of release is
lower for several reasons.
First, potentially creditable hazardous
waste pharmaceuticals must be in
original manufacturers' packaging by
definition and are often in their outer
packaging as well, providing two layers
of protection from leaks or spills.
236
Second, potentially creditable
hazardous waste pharmaceuticals are
typically generated in the pharmacy
area of a healthcare facility where there
is restricted access, creating a layer of
security for these pharmaceuticals.
Third, EPA has been informed that it is
common practice at healthcare facilities
for potentially creditable waste
pharmaceuticals that are destined for a
reverse distributor to be taken from the
shelves of the pharmacy periodically
and promptly boxed for off-site
shipment.
For the reasons listed above, EPA did
not propose specific standards for
managing and labeling containers of
potentially creditable hazardous waste
pharmaceuticals at healthcare facilities.
For the same reasons, we also did not
propose a limit on how long healthcare
facilities may accumulate containers of
potentially creditable hazardous waste
pharmaceuticals.
This is not to say that all potentially
creditable hazardous waste
pharmaceuticals waste pharmaceuticals
are safe and pose no risk of spill or
release into the environment. It is
important to note that the accumulation
of some potentially creditable hazardous
waste pharmaceuticals, such as liquids
and aerosols, may pose more of a risk
due to possible spills or leaks than solid
pills. However, EPA believes that the
small quantities in which liquid and
aerosol potentially creditable hazardous
waste pharmaceuticals are generated,
along with the DOT packaging
requirements (49 CFR parts 173, 178,
and 180), significantly reduces the risks
of spills or releases to the environment.
In addition, to further mitigate the
potential for spills or leaks, as a best
management practice, EPA encourages
healthcare facilities to place the original
containers, and packaging containing
liquids and aerosols pharmaceuticals, in
separate individual containers (e.g.,
sealed storage bag) before placing them
in the accumulation container.
1. Accumulation Time and Container
Management of Potentially Creditable
Hazardous Waste Pharmaceuticals
a. Summary of proposal. EPA did not
propose a limit on how long healthcare
facilities may accumulate containers of
potentially creditable hazardous waste
pharmaceuticals or specific standards
for how the containers must be managed
during accumulation.
b. Summary of comments. Most
commenters were in favor of adding
some guidelines for accumulation time
and container management. Some states
commented that the proposed standards
for non-creditable hazardous waste
pharmaceuticals should be applied to
both non-creditable and potentially
creditable hazardous waste
pharmaceuticals to prevent confusion
from having multiple accumulation
standards, and to provide extra
protection of human health and the
environment.
c. Final rule provisions. EPA is not
finalizing a time limit for accumulating
containers of potentially creditable
hazardous waste pharmaceuticals. EPA
is also not finalizing specific container
management standards for healthcare
facilities that accumulate containers of
potentially creditable hazardous waste
pharmaceuticals
d. Comments and responses. Several
states expressed concern about the
security of potentially creditable
hazardous waste pharmaceuticals
during accumulation. These
commenters agreed that potentially
creditable hazardous waste
pharmaceuticals should be accumulated
in a designated area that is labeled and
kept locked or sealed according to best
management practices for that facility as
an additional deterrent to illicit
diversion. Commenters also expressed
concerned that not having designated
accumulation areas could lead to
situations where healthcare facility
personnel may misplace or forget the
locations of accumulation containers.
States were concerned that the potential
for healthcare facilities to receive
manufacturer credit does not
sufficiently encourage proper
management.
As previously discussed, potentially
creditable hazardous waste
pharmaceuticals do not pose the same
risks as other hazardous wastes. We
received many comments, especially
from the retail industry, about the
condition of packages being important
for being eligible and receiving
manufacturer credit. For example,
broken and/or leaking containers cannot
be sent to a reverse distributor per the
definition of ''potentially creditable
hazardous waste pharmaceuticals,'' so
there is an incentive to manage these
items carefully. There is also an
incentive to not overaccumulate wastes
in healthcare facilities since
manufacturer credit is only issued by
reverse distributors and in many cases,
cannot be collected by a healthcare
facility until the reverse distributor
receives them.
It is also important to note that many
of these potentially creditable hazardous
waste pharmaceuticals are already being
generated and stored in secure areas,
such as pharmacies, and being handled
by personnel that have pharmaceutical
expertise. EPA is also recommending
that liquids and aerosols be put in
sealed plastic bags, containers, or other
management practices during
accumulation to reduce the risk of spills
and releases.
As for labeling the accumulation area
with the words pharmaceutical waste,
the concern still remains for increasing
the potential for illicit diversion of these
potentially creditable hazardous waste
pharmaceuticals by bringing attention to
the fact that it contains pharmaceuticals.
Therefore, the Agency is not finalizing
a requirement for healthcare facilities to
label accumulation areas for potentially
creditable hazardous waste
pharmaceuticals.
Finally, if a state is uncomfortable
with our approach to the accumulation
of potentially creditable hazardous
waste pharmaceuticals, it may choose to
be more stringent in this regard when it
adopts the rule.
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This provision is found at §
266.510(c)(9)(i)
2. Labeling Requirements for Containers
of Potentially Creditable Hazardous
Waste Pharmaceuticals
a. Summary of proposal. EPA did not
propose specific labeling standards for
containers holding potentially
creditable hazardous waste
pharmaceuticals while they are
accumulated on-site at a healthcare
facility because they are in original
manufacturer packaging, they are
already labeled, and any additional
labeling would be duplicative or apply
to secondary containers, such as boxes
used to ship to reverse distributors.
In addition, due to concerns regarding
illicit diversion of pharmaceuticals, EPA
believes that it is safer not to call
attention to the fact that these
containers hold pharmaceuticals. Unlike
floor or patient care pharmaceutical
waste, the potentially creditable
hazardous waste pharmaceuticals
returned to a reverse distributor often
have high black-market value that
makes them susceptible to diversion.
Thus, EPA did not propose to require a
label for containers used to accumulate
potentially creditable hazardous waste
pharmaceuticals.
b. Summary of comments. Many
states believe that labeling should be
required for all containers of hazardous
waste to ensure proper management and
disposal. Proper management, according
to comments, includes accumulation in
designated locations with individual
containers labeled for inspection.
Other commenters expressed
concerns that containers that are not
labeled are subject to inaccurate waste
determinations and will be mishandled
and treated as non-creditable hazardous
waste pharmaceuticals and sent to a
TSDF rather than as potentially
creditable which could ultimately be
destined for a reverse distributor.
c. Final rule provision. EPA is not
finalizing labeling standards for
containers of potentially creditable
hazardous waste pharmaceuticals
accumulated by healthcare facilities.
d. Comments and responses. While
the commenter's concerns apply to
hazardous waste in general and for
hazardous waste going to a TSDF, we do
not believe they are equally applicable
to containers of potentially creditable
hazardous waste pharmaceuticals. First,
containers of potentially creditable
hazardous waste pharmaceuticals are in
original manufacturer's packaging (or
have been repackaged for use in a LTCF)
and thus the contents are easily
identifiable. Second, if a healthcare
facility does not label an accumulation
container on site and then forgets about
it or misidentifies where it needs to go,
then no manufacturer credit will be
issued for those potentially creditable
hazardous waste pharmaceuticals.
Likewise, if a healthcare facility does
label the containers on site and the
contents are illicitly diverted, then the
healthcare facility will not receive the
manufacturer credit for those items.
Healthcare facilities have a monetary
incentive to keep track of what is in
these containers, regardless of whether
they are labeled, and to make sure they
arrive unmolested at the reverse
distributor.
Additionally, by imposing labeling
requirements, EPA does not want to
deter the practice of commingling
potentially creditable hazardous waste
pharmaceuticals with potentially
creditable non-hazardous waste
pharmaceuticals since both are typically
transported together to a reverse
distributor.
Therefore, EPA concludes that it is
not necessary to require any labeling
standards for potentially creditable
hazardous waste pharmaceuticals.
D. No Biennial Reporting for Potentially
Creditable Hazardous Waste
Pharmaceuticals Generated at
Healthcare Facilities (§
266.503(d))
1. Summary of Proposal
The Agency proposed that healthcare
facilities are not subject to biennial
reporting requirements under §
262.41
with respect to potentially creditable
hazardous waste pharmaceuticals
managed under this subpart.
2. Summary of Comments
One state commented that it would
prefer to be notified about who is
handling this waste to ensure that
healthcare facilities are adhering to the
prohibition on sewering, since they will
not know who is handling this waste.
3. Final Rule Provision
The Agency is finalizing as proposed
that healthcare facilities are not subject
to biennial reporting requirements
under §
262.41 with respect to
potentially creditable hazardous waste
pharmaceuticals managed under this
subpart. Potentially creditable
hazardous waste pharmaceutical
quantities will be captured by the
reverse distributors' required biennial
reports,
237
therefore, a requirement for
healthcare facilities to report quantities
of potentially creditable hazardous
waste pharmaceuticals generated would
be duplicative.
4. Comments and Responses
One state was concerned that they
would not know which healthcare
facilities are generating potentially
creditable hazardous waste
pharmaceuticals. All healthcare
facilities operating under this subpart
will be required to submit a one-time
notification that they are subject to
subpart P (§
266.502(a)(1)). States will,
therefore, be informed of what
healthcare facilities are operating under
subpart P and can inspect accordingly.
E. Recordkeeping Requirements for
Healthcare Facilities Managing
Potentially Creditable Hazardous Waste
Pharmaceuticals (§
266.503(e))
1. Summary of Proposal
EPA proposed to require healthcare
facilities to keep records of the
shipments of potentially creditable
hazardous waste pharmaceuticals to
reverse distributors.
Specifically, we proposed that
healthcare facilities that initiate a
shipment of potentially creditable
hazardous waste pharmaceuticals to a
reverse distributor keep (1) records of
advance notification, (2) shipping
papers or bills of lading, and (3) records
of delivery confirmation. We proposed
that a healthcare facility must retain
these records for three years after the
shipment was initiated. These records
document that shipments of potentially
creditable hazardous waste
pharmaceuticals have been taken into
the control and custody of the receiving
reverse distributor and have not been
diverted. In most cases, retaining
records for three years should be
sufficient for inspection purposes;
however, we proposed that the periods
of retention are automatically extended
during unresolved enforcement activity,
or at the request of the EPA Regional
Administrator.
2. Summary of Comments
One state agreed that three years was
a sufficient retention period to enable
inspectors to identify issues upon
inspection. State and local governments
requested clarification about what types
of documentation (e.g., shipping papers/
bills of lading) satisfies the requirement.
One commenter argued that the
receiving facility should document
efforts made to locate shipments that
did not arrive.
3. Final Rule Provision
EPA is finalizing the proposed
recordkeeping provision for potentially
creditable hazardous waste
pharmaceuticals for healthcare facilities
and reverse distributors that initiate a
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Since the hazardous waste pharmaceutical
rule was proposed, §
261.5 has been renumbered to
§
262.14 as part of the reorganization of the
generator regulations in the Generator
Improvements final rule and this will be referenced
later in this section.
239
Since the Pharmaceutical rule was
proposed§
261.5(f)(3)(i)-(vii) for acute hazardous
waste and §
261.5(g)(3)(i)-(vii) for non-acute
hazardous waste has been combined and
renumbered to §
262.14(a)(5)(i)-(vii) for acute and
non-acute hazardous waste in the Hazardous Waste
Generator Improvements final rule.
240
A VSQG healthcare facility may be able to
send its hazardous waste pharmaceuticals for
consolidation at another healthcare facility
operating under subpart P as allowed by
§
266.504(b), or a large quantity generator and
262.14(a)(5)(viii), see section X of the preamble for
further discussion.
shipment to another reverse distributor
with two changes. First, as we discuss
later in the shipping standards, we have
eliminated the requirement for
healthcare facilities to provide advance
notification of shipments of potentially
creditable hazardous waste
pharmaceuticals to reverse distributors.
Thus, we have removed the requirement
to keep a record of the advance
notification. Second, EPA removed the
reference to bills of lading from the
recordkeeping requirement while
keeping shipping papers since bills of
lading are a type of shipping papers
under DOT regulations. This is also
responsive to comments asking for
clarification. Healthcare facilities
initiating shipments of potentially
creditable hazardous waste
pharmaceuticals must keep, (1) delivery
confirmation for each shipment and (2)
shipping papers prepared in accordance
with 49 CFR part 172 subpart C, if
applicable. EPA is finalizing that these
records must be retained for three years
unless there is an unresolved
enforcement activity or a request by the
EPA Regional Administrator to keep
them longer. In that case, the period of
retention is automatically extended.
EPA is finalizing this requirement as
proposed despite input from
commenters, as this is standard practice
with enforcement activity. At the
request of commenters, we have added
a requirement that all records must be
readily available upon request by an
inspector.
F. Response to Spills for Healthcare
Facilities Managing Potentially
Creditable Hazardous Waste
Pharmaceuticals (§
266.503(f))
1. Summary of Proposal
EPA proposed response requirements
for spills of non-creditable hazardous
waste pharmaceuticals but did not
propose similar response requirements
for releases of potentially creditable
hazardous waste pharmaceuticals.
2. Summary of Comments
A commenter suggested that spills of
potentially creditable hazardous waste
pharmaceuticals should also be subject
to the same containment and cleanup
requirements as non-creditable
hazardous waste pharmaceuticals. The
commenter also asked whether EPA
intended that all spills of potentially
creditable hazardous waste
pharmaceuticals render them non-
creditable.
3. Final Rule Provision
EPA agrees with comments that all
spills of hazardous waste
pharmaceuticals, both potentially
creditable and non-creditable, must be
contained, and that all spills of
potentially creditable hazardous waste
pharmaceuticals renders them non-
creditable. Therefore, in response to this
comment, we have added a similar
provision to the healthcare facility
standards of §
266.503(f) for responding
to releases of potentially creditable
hazardous waste pharmaceuticals.
The standards in this section are
based upon what is being finalized in
the standards for response to spills of
non-creditable hazardous waste
pharmaceuticals at healthcare facilities
in §
266.502(k). The final rule requires
that a healthcare facility must
immediately contain all spills of
potentially creditable hazardous waste
pharmaceuticals and manage the spill
clean-up materials as non-creditable
hazardous waste pharmaceuticals in
accordance with subpart P.
It is EPA's understanding that
unused/undispensed pharmaceuticals
that remain in original manufacturer's
packaging often receive manufacturer
credit even if the packaging has been
opened. In the event of a spill, a
healthcare facility should reevaluate
whether any pharmaceuticals that
remain in their containers (not spilled)
are still eligible to receive manufacturer
credit per the definition of potentially
creditable hazardous waste
pharmaceutical in §
266.500. The
healthcare facility must determine
whether the pharmaceuticals that
remain in the containers are potentially
creditable and manage them according
to subpart P. Even if a healthcare facility
determines that the remaining
pharmaceuticals are potentially
creditable, it must also ensure that the
decision is consistent with the
manufacturer's policies. It is important
to note that this only applies to
whatever might be left in the container
and was not spilled.
XII. How does this rule apply to
healthcare facilities that are very small
quantity generators for both their
hazardous waste pharmaceuticals and
their non-pharmaceutical hazardous
waste? (§
266.504)
A. Very Small Quantity Generators
Using Reverse Distributors (§
266.504(a))
1. Summary of Proposal
VSQGs are subject to a limited set of
federal RCRA Subtitle C hazardous
waste regulations, provided that they
comply with the conditions set forth in
§
262.14.
238
Under §
262.14, VSQGs are
limited in where they may send their
hazardous waste for treatment and
disposal.
239
In §
266.504(a), we
proposed to allow VSQG healthcare
facilities to send their potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor.
Without this change, VSQGs would
have been required to send all their
hazardous waste pharmaceuticals,
including those that are potentially
creditable, to one of the types of
facilities in §
262.14, which does not
include a reverse distributor. Although
we proposed to make this change within
part 266 subpart P, we requested
comment on whether stakeholders
would prefer this change to be made
within the VSQG regulations in §
262.14
(formerly the CESQG regulations in
§
261.5) instead. VSQGs are still
required to send their non-
pharmaceutical hazardous waste and
their non-creditable hazardous waste
pharmaceuticals to one of the types of
facilities listed in §
262.14.
240
2. Summary of Comments
States, waste management and reverse
distributors supported allowing VSQG
healthcare facilities to send their
potentially creditable hazardous waste
to reverse distributors. These same
commenters were also in favor of
including their change in both this rule
and §
262.14 to ensure that all
healthcare facilities that might have
potentially creditable hazardous waste
pharmaceuticals would be aware of this
provision and be able to take advantage
of it.
3. Final Rule Provision
We are finalizing this provision as
proposed, with minor edits. In general,
this final rulemaking will preserve the
current regulatory scheme for VSQGs:
healthcare facilities that qualify as
VSQGs for their total count of hazardous
waste pharmaceuticals and non-
pharmaceutical hazardous waste will
maintain their conditional exemption
under §
262.14 and will not be subject
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to most aspects of this proposal.
Healthcare facilities that are VSQGs are
subject to three provisions of part 266
subpart P: The sewer ban in §
266.505,
the empty container standards in
§
266.507, and the optional provisions
in §
266.504.
In response to commenter's request
for clarity, the final rule makes it clear
that §
266.504 applies to VSQG
healthcare facilities that are VSQGs
when counting both its hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste.
Section 266.504 does not apply to
healthcare facilities that become VSQGs
under this rule as a result of not having
to count their hazardous waste
pharmaceuticals. Such healthcare
facilities are VSQGs with respect to
their non-pharmaceutical hazardous
waste only and must operate under
subpart P for their hazardous waste
pharmaceuticals.
Under the final rule, a healthcare
facility that is a VSQG when counting
both its hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste may
choose to send its potentially creditable
hazardous waste pharmaceuticals to a
reverse distributor. In response to
comments, EPA has added a conforming
change to the VQSG generator provision
in §
262.14(a)(5)(ix) for added clarity on
this point. It is a restatement of
§
266.504(a) which allows VSQG
healthcare facilities to send their
potentially creditable hazardous waste
pharmaceuticals to a reverse distributor.
A healthcare facility that is a VSQG
for both their hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste is
given a choice. The healthcare facility
may
.
Operate as a standard VSQG under part
262 rules, and can use the optional
provisions in §
266.504, or
.
Operate under as a healthcare facility
under part 266 subpart P.
4. Comments and Responses
The waste management industry
requested that EPA regulate all
healthcare facilities under the proposed
subpart P requirements regardless of
generator category. While this rule's
requirements are meant to create
uniformity for healthcare facilities
managing hazardous waste
pharmaceuticals, we want to avoid
creating undue burden on VSQGs and
have declined to make them subject to
part 266 subpart P except for the sewer
prohibition in §
266.505, the empty
container provisions in §
266.507 and
the optional provisions in §
266.504..
B. Off-Site Collection of Hazardous
Waste Pharmaceuticals Generated by
Healthcare Facilities (§
266.504(b))
1. Summary of Proposal
EPA proposed that a healthcare
facility that is a VSQG may send its
hazardous waste pharmaceuticals to
another healthcare facility provided the
receiving healthcare facility meets
certain conditions. These conditions
were proposed in §
266.502(m) of this
subpart.
2. Summary of Comments
One state was concerned about how
consolidation might affect the generator
category of the receiving facility. The
commenter also raised concerns about
the receiving facility performing some
functions of a reverse distributor.
3. Final Rule Provision
EPA is finalizing the proposed
provision with conforming changes that
correspond with other sections within
this rule and one additional change. The
first conforming change added the
words ''hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste'' to
clarify that only healthcare facilities that
are VSQGs for both their hazardous
waste pharmaceuticals and their non-
pharmaceutical hazardous waste may
take advantage of this provision. The
second conforming change converted
the term CESQG to VSQG according to
the 2016 Hazardous Waste Generator
Improvements final rule. EPA notes that
the consolidation provisions for
healthcare facilities that receive both
non-creditable hazardous waste
pharmaceuticals and potentially
creditable hazardous waste
pharmaceuticals from off-site were
added to the regulations in §§
266.502(l)
and 266.503(b) (sections X.N and XI.B of
the preamble), respectively. The final
change added flexibility for VSQGs to
meet the consolidation provisions that
were added as part of the 2016
Hazardous Waste Generator
Improvements final rule in lieu of the
subpart P off-site consolidation
provisions. In this case, the receiving
LQG would have to meet the conditions
in §
262.17(f) while the VSQG
healthcare facility would have to meet
the conditions in §
262.14(a)(5)(viii).
The final rule provision allows a
healthcare facility that is a VSQG for
both hazardous waste pharmaceuticals
and non-pharmaceutical hazardous
waste to send its hazardous waste
pharmaceuticals off-site provided either
of the following is met: (1) The receiving
healthcare facility meets the conditions
in §
266.502(1) and §
266.503(b) of this
subpart, as applicable, or (2) the VSQG
healthcare facility meets the conditions
in §
262.14(a)(5)(viii), and the receiving
large quantity generator meets the
conditions in §
262.17(f).
4. Comments and Responses
One commenter asked for clarification
about whether EPA will allow
consolidation of a healthcare facility's
potentially creditable or non-creditable
hazardous waste pharmaceuticals at a
reverse distributor. In response, the
Agency is clarifying that subpart P does
not allow healthcare facilities to
consolidate any pharmaceutical waste at
a reverse distributor. Healthcare
facilities may only consolidate their
waste at another facility that meets the
definition of a healthcare facility as
defined in §
266.500. See sections X.N
and XI.B, respectively, for further
discussion about healthcare facilities
that receive non-creditable and
potentially creditable hazardous waste
pharmaceuticals from off-site healthcare
facilities.
C. Long-Term Care Facilities That Are
Very Small Quantity Generators Can
Dispose Hazardous Waste
Pharmaceuticals in Drug Enforcement
Administration Collection Receptacles
(§
266.504(c))
1. Summary of Proposal
We proposed that a LTCF that is a
VSQG that has an on-site DEA
collection receptacle could use the
collection receptacle for its hazardous
waste pharmaceuticals, even if they are
not controlled substances. We reasoned
that since DEA already allows
controlled substances to be commingled
with non-controlled substances, it was
consistent to allow VSQG hazardous
waste pharmaceuticals that are not
controlled substances to be placed in
DEA authorized collection receptacles
along with controlled substances.
Further, we reasoned that the
management of VSQG hazardous waste
pharmaceuticals as DEA controlled
substances is preferable to management
as municipal solid waste because it
provides greater protection to patients,
visitors, and workers at LTCFs to have
the hazardous waste pharmaceuticals in
DEA authorized collection receptacles
than down the sewer or in the facility's
regular trash.
2. Summary of Comments
The few comments we received on
this specific provision of the proposed
rulemaking were mostly supportive.
3. Final Rule Provisions
We are finalizing the provision that
allows an LTCF that is a VSQG to use
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241
See comment number EPA-HQ-RCRA-2007-
0932-0280.
242
See comment number EPA-HQ-RCRA-2007-
0932-0238 in the docket for this rulemaking.
243
See comment number EPA-HQ-RCRA-2007-
0932-0242 in the docket for this rulemaking.
244
See comment number EPA-HQ-RCRA-2007-
0932-0332 in the docket for this rulemaking.
245
See comment numbers EPA-HQ-RCRA-2007-
0932-0239 and EPA-HQ-RCRA-2007-0932-0282
in the docket for this rulemaking.
246
See comment number EPA-HQ-RCRA-2007-
0932-0328 in the docket for this rulemaking.
a DEA authorized collection receptacle
to dispose of its hazardous waste
pharmaceuticals with three minor
changes. The first change is to clarify
again that this provision only applies to
LTCFs that are VSQGs for both
hazardous waste pharmaceuticals and
non-pharmaceutical hazardous waste
and are therefore not subject to subpart
P (except the sewer prohibition of
§
266.505, the empty container
standards of §
266.507, and the optional
provisions of §
266.504). The second
change is to clarify that the DEA
authorized collection receptacle that the
VSQG LTCF uses to dispose of its
hazardous waste pharmaceuticals must
be on-site. The third change is to
exclude items such as contaminated
personal protective equipment or clean-
up residues from being placed into the
DEA authorized collection receptacle.
Although these items meet our new
definition of pharmaceutical, a DEA
authorized collection receptacle is
designed for the collection of the
pharmaceuticals themselves and not
larger items that might be contaminated
by the pharmaceuticals, such as
contaminated PPE or clean-up residues.
For instance, they are required to have
small openings and limited volumes,
making their use for contaminated PPE
and clean-up residues impractical.
4. Comments and Responses
One commenter thought that this
proposed provision was ''not feasible''
because ''take-back kiosks for controlled
substances are intended to be used by
end users and not the DEA
registrant.''
241
In many, if not most,
cases at an LTCF, the hazardous waste
pharmaceuticals will be from an
ultimate user and the DEA regulations
permit the collection receptacles to be
used for collecting both controlled and
non-controlled substances from ultimate
users. There are more limited cases
where an LTCF may have its own
inventory of non-controlled hazardous
waste pharmaceuticals.
Although EPA concurs with the
commenters that the DEA authorized
collection receptacles are only for
controlled substances from ultimate
users, EPA does not believe that the
same limitation needs to be placed on
the pharmaceuticals from VSQGs that
are hazardous waste but not controlled
substances. In fact, it could be argued
that long-term care facilities that are
VSQGs would be allowed to use DEA
authorized collection receptacles for
their hazardous waste pharmaceuticals
even without this new provision,
provided the waste from the DEA
authorized collection receptacles is
treated or disposed at one of the types
of facilities identified in §
262.14(a)(5)
(e.g., facilities that are permitted or have
interim status to manage hazardous
waste and facilities that are permitted,
licensed or registered by a state to
manage hazardous waste, municipal
waste or non-municipal waste).
Nevertheless, we did propose, and are
finalizing the provision in §
266.504(c)
making it clear that an LTCF that is a
VSQG can place its hazardous waste
pharmaceuticals in an on-site DEA
collection receptacle.
However, as the commenter pointed
out, it is important to note that the DEA
regulations for controlled substances are
much narrower in what may be placed
in a collection receptacle; DEA only
allows controlled substances from
ultimate users (patients) to be placed in
collection receptacles that are at long-
term care facilities. As a result, if a
LTCF (or any other healthcare facility)
is a DEA registrant, it may not place its
inventory of controlled substances in a
collection receptacle, even if it is a
VSQG.
D. Long-Term Care Facilities With 20
Beds or Fewer Are Presumed To Be Very
Small Quantity Generators
(§
266.504(d))
1. Summary of Proposal
EPA took comment on whether we
should provide a rebuttable
presumption that LTCFs with fewer
than 10 beds are assumed to be VSQGs
and thus would not be required to keep
track of the amount of hazardous waste
generated each month. The Agency did
not propose regulatory language for this
provision. EPA asked commenters to
submit data to support a 10-bed cutoff
to show that LTCFs with fewer than 10
beds are generally VSQGs.
Alternatively, if commenters supported
a different cutoff for the rebuttable
assumption, EPA asked that the
commenters submit information to
support their suggested cutoff.
2. Summary of Comments
Comments on the rebuttable
presumption for LTCFs with fewer than
10 beds varied. One state did not
support providing a rebuttable
presumption for LTCFs with fewer than
10 beds and argued that all generators
should be required to count the
hazardous waste they generate.
242
One
state expressed support for providing a
rebuttable presumption and requested
that EPA keep the cutoff at 10 beds.
243
One state did not support providing the
rebuttable presumption because most
healthcare facilities in their state,
including LTCFs, have more than 10
beds but generate only VSQG quantities
of hazardous waste.
244
Two healthcare industry commenters
that supported the rebuttable
presumption asked that EPA increase
the cutoff from 10 beds to 20 beds.
245
One healthcare industry commenter
supported the rebuttable presumption
and asked that EPA increase the bed
cutoff from 10 beds to 15 beds.
246
3. Final Rule Provisions
Under the final rule, EPA is finalizing
a rebuttable presumption in §
266.504(d)
that LTCFs with 20 beds or fewer are
assumed to be VSQGs and thus are not
required to demonstrate the amount of
hazardous waste generated each month.
Under this presumption, LTCFs are only
subject to the requirements for VSQG
healthcare facilities as described
elsewhere in this proposal, including
the requirement not to sewer hazardous
waste pharmaceuticals (§
266.505), the
empty container standards (§
266.507),
and the optional provisions of
§
266.504. Under the final rule, the EPA
Regional Administrator has the
responsibility to demonstrate that a
LTCF with 20 beds or fewer generates
quantities of hazardous waste that are in
excess of the VSQG limits as defined in
§
260.10 if the EPA Regional
Administrator wishes to mandate that
the LTCF operate under subpart P. A
LTCF with more than 20 beds that
operates as a VSQG under §
262.14 must
demonstrate that it generates quantities
of hazardous waste that are within the
VSQG limits as defined by §
260.10.
Based on available data, EPA believes
it is reasonable to be responsive to the
healthcare industry commenters who
supported the rebuttable presumption
and to increase the cutoff to 20 beds.
The available information on hazardous
waste generation at LTCFs suggests that
LTCFs with 20 beds or fewer are
generally VSQGs. Although EPA did not
receive any data from the healthcare
industry commenters, one state
commented that most healthcare
facilities in their state, including LTCFs,
have many more than 10 beds but
generate only VSQG quantities of
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See comment number EPA-HQ-RCRA-2007-
0932-0332 in the docket for this rulemaking.
248
Regulatory Impact Analysis in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
249
See memorandum ''Long-Term Care Facility
Summary Data and Hazardous Waste Generation
Data'' in the docket for this rulemaking (EPA-HQ-
RCRA-2007-0932).
250
May 19, 1980; 45 FR 33097.
251
See the advance notice of proposed
rulemaking in August 22, 1986; 51 FR 30166.
252
See the response to comments in June 22,
1987; 52 FR 23477.
253
See the proposed rule November 23, 1988; 53
FR 47632.
254
See the final rule in July 24, 1990; 55 FR
30082.
255
See the prohibition in 40 CFR 403.5(b)(1).
256
See 40 CFR 261.23(a)(2).
257
See 40 CFR 261.23(a)(3).
258
See 40 CFR 403.5(b)(7).
259
See 40 CFR 261.23(a)(4).
260
See 40 CFR 261.23(a)(5).
261
July 24, 1990 Federal Register; 55 FR 30084.
hazardous waste.
247
Additionally, EPA
estimates that there are between 2,875
and 4,770 long-term care facilities that
generate hazardous waste and that 98 to
99 percent of the facilities are
VSQGs.
248
Although EPA estimates that
there are few LTCF hazardous waste
generators that are SQGs or LQGs, EPA
does not have data on the number of
beds at each facility, making it difficult
to estimate a facility size threshold at
which a LTCF becomes an SQG or an
LQG. EPA conducted additional
analysis using data on the average size
of LTCFs in the United States and data
on the average volume of hazardous
waste generated annually at LTCFs that
submitted a biennial hazardous waste
report between 2001 and 2015 in order
to estimate the average size at which a
LTCFs become SQGs or LQGs.
249
The
estimates suggest that LTCFs with fewer
than 20 beds will generally be VSQGs.
Therefore, EPA concludes that it is
reasonable to provide a rebuttable
presumption that LTCFs with 20 beds or
fewer are assumed to be VSQGs and
thus are not required to demonstrate the
amount of hazardous waste generated
each month.
XIII. Sewer Disposal Prohibition
(§
266.505)
A. Regulatory Background on the
Domestic Sewage Exclusion
Under RCRA and the Subtitle C
hazardous wastes regulations, if a
material is not a solid waste, then it
cannot be considered a hazardous
waste. Under §
261.4(a)(1)(ii) of the
RCRA regulations, ''Any mixture of
domestic sewage and other wastes that
passes through a sewer system to a
publicly-owned treatment works for
treatment'' is not a solid waste for
purposes of Subtitle C regulation. This
exclusion was finalized by EPA on May
19, 1980, based on the reasoning that
''Mixed waste streams that pass through
sewer systems to publicly-owned
treatment works (POTWs) will be
subject to controls under the Clean
Water Act (CWA). The Agency's
construction grants program provides
financial assistance for the proper
treatment of these wastes. In addition,
the Agency's pretreatment program
provides a basis for EPA and the local
communities to ensure that users of
sewer and treatment systems do not
dump wastes in the system that will
present environmental problems.''
250
In 1984, Congress enacted the
Hazardous and Solid Waste
Amendments (HSWA) to the Solid
Waste Disposal Act (SWDA), as
amended by RCRA. HSWA included a
new Section 3018, entitled Domestic
Sewage. This section directed EPA to do
two things with respect to the
§
261.4(a)(1)(ii) exclusion for mixtures
of domestic sewage and other wastes: (1)
Submit a Report to Congress (RTC) that
describes the types, size and number of
generators which dispose of such wastes
in this manner, the types and quantities
of wastes disposed of in this manner,
and identify significant generators,
wastes and waste constituents not
regulated under existing Federal law or
regulated in a manner sufficient to
protect human health and the
environment; and (2) based on the
report, revise the appropriate existing
regulations to ''ensure that substances
.
.
. which pass through a sewer system
to a publicly owned treatment works are
adequately controlled to protect human
health and the environment.''
EPA submitted its Report to Congress
on February 7, 1986 (Domestic Sewage
Study). Subsequent to the Report to
Congress, EPA issued an advance notice
of proposed rulemaking on August 22,
1986;
251
a response to comments on the
advanced notice of proposed
rulemaking on June 22, 1987;
252
a
notice of proposed rulemaking (NPR) on
November 23, 1988;
253
and a final rule
on July 24, 1990.
254
That final rule
expanded an existing prohibition on the
discharge of pollutants which create a
fire or explosion hazard in the POTW,
so that it included, but was not limited
to, ''waste streams with a closed cup
flashpoint of less than 140 degrees
Fahrenheit or 60 degrees Centigrade
using the test methods specified in 40
CFR 261.21.''
255
Although the RCRA
characteristic of reactivity (D003) was
not specifically mentioned in the CWA
regulations, discharges of some D003
reactive hazardous wastes are also
prohibited by this section of the CWA
regulations: (1) Chemicals that react
violently with water
256
and (2)
chemicals that form potentially
explosive mixtures with water.
257
The 1990 CWA final rule added a new
prohibition such that no discharge shall
''result in the presence of toxic gases,
vapors or fumes within the POTW in a
quantity that may cause acute worker
health and safety problems.''
258
Similarly, although the RCRA
characteristic of reactivity (D003) was
not specifically mentioned in this
section of the CWA regulations,
discharges of some D003 reactive
hazardous wastes are also prohibited by
this section: (1) Chemicals that, when
mixed with water, generate toxic gases,
vapors or fumes in quantity sufficient to
present a danger to human health or the
environment
259
or (2) cyanide or sulfide
bearing waste which, when exposed to
pH conditions between 2 and 12.5, can
generate toxic gases, vapors or fumes in
a quantity sufficient to present a danger
to human health or the environment.
260
In addition, some D002 corrosive
hazardous wastes were prohibited prior
to the 1990 CWA final rule and remain
prohibited. Under RCRA, a waste is
considered D002 for corrosivity if it has
a pH of less than or equal to 2 (strongly
acidic) or greater than or equal to 12.5
(strongly basic). Section 403.5(b)(2) of
the CWA regulations prohibits
discharges with a pH of less than 5.0,
except under limited circumstances.
Therefore, acidic D002 hazardous waste
is prohibited from being discharged
under the CWA regulations.
Note that although the exclusion for
mixtures of domestic sewage and other
wastes is found under the RCRA
regulations in §
261.4(a)(1)(ii), and it
was HSWA, which is an amendment to
RCRA, that directed the review of and
amendments to that exclusion, the
sewer ban of liquid ignitable D001
hazardous wastes and some D002 and
D003 hazardous wastes was established
under 40 CFR 403.5(b), which is under
the CWA regulations. Also note that
EPA left open the possibility of
additional future action when it stated
in the preamble to the July 24, 1990,
final rule, its intent ''to carefully review
the effect of this rule and promulgate in
the future any additional regulations
that experience reveals are necessary to
improve control over hazardous waste
and other industrial user discharges to
POTWs.''
261
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July 24, 1990 Federal Register; 55 FR 30084.
263
EPA, Occurrence of Contaminants of Emerging
Concern in Wastewater from Nine Publicly Owned
Treatment Works, August 2009; EPA-821-R-09-
009.
264
Eggen RI, Hollender J, Joss A, Scha
¨rer M,
Stamm C, ''Reducing the Discharge of
Micropollutants in the Aquatic Environment: The
Benefits of Upgrading Wastewater Treatment
Plant.'' Environmental Science and Technology
2014, 48(14) 7683-7689.
265
Kostich MS, Batt AL, Lazorchak JM,
''Concentrations of prioritized pharmaceuticals in
effluents from 50 large wastewater treatment plants
in the US and implications for risk estimation.''
Environmental Pollution 2014, 184:354-9.
266
Health Services Industry Study: Management
and Disposal of Unused Pharmaceuticals (Interim
Technical Report) August 2008; EPA-821-R-08-
013.
267
Richmond EK, Grace MR, Kelly JJ, Reisinger
AJ, Rosi EJ, Walters, DM. ''Pharmaceuticals and
personal care products (PPCPs) are ecological
disrupting compounds (EcoDC).'' Elem Sci Anth
2017, 5:66.
268
See page 147 of the Regulatory Impact
Analysis for the proposed rule in the docket EPA-
HQ-RCRA-2007-0932-0151.
269
A. Ginebreda et al., Environmental risk
assessment of pharmaceuticals in rivers:
Relationships between hazard indexes and aquatic
macroinvertebrate diversity indexes in the Llobregat
River (NE Sapin). Environ Int. (2009), doi:10.1016/
j.envint.2009.10.003.
270
See the Regulatory Impact Analysis for the
final rule in the docket EPA-HQ-RCRA-2007-
0932.
271
Ibid.
272
Ibid.
273
September 9, 2014; 79 FR 53520.
274
Proposed rule: December 21, 2012; 77 FR
75784 (see page 75803); and Final rule: September
9, 2014; 79 FR 53520 (see page 53548).
B. Summary of Proposal
In 2015, EPA proposed to impose a
sewer ban on all hazardous waste
pharmaceuticals managed by healthcare
facilities and reverse distributors. That
is, healthcare facilities and reverse
distributors subject to part 266 subpart
P would not be able to use the RCRA
domestic sewage exclusion in
§
261.4(a)(1)(ii) any longer for their
hazardous waste pharmaceuticals. They
would be prohibited from disposing of
pharmaceuticals that are listed
hazardous waste and/or exhibit one or
more of the four hazardous waste
characteristics (i.e., ignitability,
corrosivity, reactivity, or toxicity) by
putting them down a drain (e.g., sink,
toilet, or floor drain).
EPA proposed this sewer prohibition
of hazardous waste pharmaceuticals for
several reasons. First, as described in
detail in the preamble to the proposed
rulemaking, a number of studies had
shown that flushing of leftover
medications had become a prevalent
practice used in lieu of proper
hazardous waste management and that
experience had, indeed, revealed that
additional regulations were ''necessary
to improve control over hazardous
waste and other industrial user
discharges to POTWs.''
262
Second, although EPA establishes
national regulations under the CWA
(called effluent limitations guidelines
and pretreatment standards) to reduce
discharges of pollutants from industries
to surface waters and POTWs, currently
there are no national effluent limitations
or pretreatment standards that apply to
healthcare facilities discharging
pharmaceuticals to POTWs.
Furthermore, traditional wastewater
treatment operations implemented at
POTWs are designed to remove
conventional pollutants, such as
suspended solids and biodegradable
organic compounds. They are not
designed to remove pharmaceuticals
that are present in discharges from
medical and veterinary facilities. While
some POTWs may have implemented
advanced treatment technologies, these
technologies are not designed to remove
pharmaceuticals. EPA released a study
in 2009 in which over 100 chemicals
(including some pharmaceuticals) were
analyzed in the influent and effluent at
nine POTWs.
263
Although it was a
limited study and difficult to generalize
the results to all POTWs, it does
indicate that the capabilities of
treatment technologies currently
employed by POTWs does not include
treatment to remove active
pharmaceutical ingredients (APIs).
264
In
a more recent study, EPA measured
concentrations of 56 APIs in effluent
samples from 50 large POTWs across the
country and discovered at least one API
in each sample.
265
In addition, as stated
in EPA's Health Services Industry study,
''synthetic compounds, such as
pharmaceuticals, are often
manufactured to be resistant to
metabolic transformation. As a result,
some pharmaceutical compounds that
are present in the influent to POTWs
may pass through treatment systems at
conventional POTWs and discharge to
receiving waters.''
266
Third, the pharmaceuticals entering
the environment, through flushing or
other means, are having a negative effect
on aquatic ecosystems and on fish and
animal populations. A recent article
highlighted the scientific literature that
examines the effect of pharmaceuticals
on freshwater ecosystems, particularly
the effect of pharmaceuticals on key
ecological processes.
267
The RIA for the
proposed rulemaking more fully
summarized the scientific literature
with regard to ecological effects.
268
The
scientific research with regard to human
health effects due to pharmaceuticals in
the environment is still ongoing.
Nevertheless, the important features and
risks of the problem can be summarized
as follows:
269
(1) Pharmaceuticals are intrinsically
bioactive compounds; therefore, they
can potentially impact living systems.
(2) There is a continuous and
worldwide increase in their use and,
thus, on their subsequent input into the
environment.
(3) Many of the hundreds of
frequently prescribed pharmaceuticals
are known for targeted effects and
adverse off-target side effects, a problem
that can be exacerbated by interactive
effects during therapy involving co-
administration and disposal.
While healthcare facilities that are
VSQGs were generally not subject to the
proposed rulemaking, EPA proposed
that the sewer ban of hazardous waste
pharmaceuticals also apply to
healthcare facilities that are VSQGs. The
RIA for the rule projects that the vast
majority of healthcare facilities are
VSQGs (81-86 percent).
270
Some
particular types of healthcare facilities
have an even larger proportion of
VSQGs: For example, the RIA estimates
that of the LTCFs that generate
hazardous waste, 98-99 percent of
LTCFs are VSQGs.
271
EPA was and
remains concerned that these smaller
healthcare facilities are more likely to
dispose of their hazardous waste
pharmaceuticals via the sewer. EPA
estimates that there are between 50,900
and 84,800 healthcare facilities that are
VSQGs.
272
Given this large number, the
combined impact of sewer disposal by
healthcare facilities that are VSQGs has
an even greater potential to provide a
substantial impact on the environment,
as well as human health. EPA solicited
comment on whether it was appropriate
to apply the proposed ban on the sewer
disposal of hazardous waste
pharmaceuticals to all healthcare
facilities, including healthcare facilities
that are VSQGs. Comments submitted to
the Agency in response to this request
are discussed in the next section.
We note that EPA's proposed ban on
sewering hazardous waste
pharmaceuticals is consistent with other
federal state, and local actions. For
example, the DEA has finalized
regulations to implement the Secure and
Responsible Drug Disposal Act of
2010.
273
DEA's regulations require a
''non-retrievable'' method of destruction
of controlled substances. The preamble
to DEA's proposed and final rules state
that flushing does not meet the non-
retrievable standard for destruction.
274
According to the preamble of the DEA
final rule, DEA received 20 comments
supporting their position against
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September 9, 2014; 79 FR 53520 (see page
53548).
276
See comment number: EPA-HQ-RCRA-2007-
0932-0242.
277
Illinois Public Act 096-0221.
278
Nicknamed Bateman's Law, after Senator
Christopher ''Kip'' Bateman (R-Somerset) that
sponsored the legislation.
279
Humphreys, et al. Environmental Health
Perspectives. 2008 March; 116(3) 297-302.
280
See comment number: EPA-HQ-RCRA-2007-
0932-0378.
281
DCMR Title 22-B Chapter 5 Safe Disposal of
Unused Pharmaceuticals in Health Care Facilities
282
State of Connecticut General Assembly,
January Session 2013, Raised Bill No. 6439. An Act
Concerning the Disposal and Collection of Unused
Medication.
283
See comment number EPA-HQ-RCRA-2007-
0932-0341.
284
In a DEA letter dated October 17, 2014, DEA
refers to leftover, partially administered drugs as
''pharmaceutical wastage.'' https://
www.deadiversion.usdoj.gov/drug_disposal/dear_
practitioner_pharm_waste_101714.pdf
285
See comment number EPA-HQ-RCRA-2007-
0932-0337.
flushing controlled substances.
275
The
comments supporting the prohibition
against sewering came from states,
regional, and local hazardous waste
management programs, recycling
associations, non-governmental
organizations (NGOs), trade associations
and environmental organizations. Many
of these commenters noted that
wastewater treatment systems do not
eliminate many of the drugs that are
flushed into the sewers and requested
that DEA clearly state in the regulatory
language, not just preamble, that
sewering is not allowable as a means of
destruction.
In addition, four states, the District of
Columbia, and local California
jurisdictions have taken action to limit
the sewering of pharmaceuticals and
another state has introduced a bill.
''Colorado has prohibited the
discharging of solid/hazardous waste
down the drain since the adoption of
RCRA in the 1980s.''
276
In 2009, Illinois
passed the Safe Pharmaceutical Disposal
Act, which prohibits healthcare
facilities from flushing any solid dosage
form other than DEA schedule II drugs
into public sewers or septic systems.
277
In 2012, New Jersey passed a similar
law that prohibits healthcare facilities
from discharging prescription
medications into public sewers or septic
systems.
278
In 2002, California banned
the use of lindane in pharmaceuticals
after it found that lindane was adversely
impacting wastewater quality. The
authors of the paper ''Outcomes of the
California Ban on Pharmaceutical
Lindane: Clinical and Ecologic Impacts
state that ''This is the first time that a
pharmaceutical has been outlawed to
protect water quality.''
279
After
researching and documenting
environmental benefits of the ban, the
authors conclude, ''This ban serves as a
model for governing bodies considering
limits on the use of lindane or other
pharmaceuticals.'' Also in California,
some county departments, such as
Sacramento County and Contra Costa
County, prohibit sewering of hazardous
waste pharmaceuticals.
280
And the
District of Columbia has promulgated
municipal regulations, effective January
1, 2011, that prohibits healthcare
facilities from flushing pharmaceutical
products.
281
The Connecticut legislature
has also considered a bill to ban the
discharge of medication into public or
private wastewater collection systems or
septic systems, although it has not yet
become law.
282
Nevertheless, the
Connecticut Department of Energy and
Environmental Protection's (CT DEEP)
''current hazardous waste management
regulations essentially ban sewer
disposal of RCRA waste by requiring all
generators in Connecticut, including
[VSQGs], to ensure delivery by a
licensed waste transporter with an EPA
ID Number to a facility authorized to
receive the waste.''
283
The Agency sought comment on
several areas related to the prohibition
on sewering hazardous waste
pharmaceuticals. First, the Agency
requested comment on whether the
sewer ban should apply to healthcare
facilities that are VSQGs. Second, we
requested comment on the trade-offs
inherent in prohibiting sewer disposal;
that is, would the benefit of the
reduction in aquatic risk be outweighed
by additional opportunities for
diversion and the possibility of
inadvertent exposures for certain
workers? Third, we sought comment on
whether it would be appropriate to
allow any exceptions to the sewer ban,
such as for leftover portions of
hazardous wastes that are also
controlled substances.
284
Finally, the
Agency sought comment on whether it
would be helpful to incorporate in 40
CFR 261.4(a)(1)(ii), a cross-reference to
the CWA regulations that prohibit the
sewering of certain hazardous wastes.
C. Summary of Comments
Nearly a third of the commenters to
the proposed rulemaking commented on
the proposed prohibition of sewering
hazardous waste pharmaceuticals.
Commenters were nearly unanimous in
their support for the prohibition on
sewering of hazardous waste
pharmaceuticals. Support was
expressed by a broad and diverse set of
commenters, including state and local
governments, sewer districts,
environmental groups, and waste
management companies. Although some
commenters had suggestions for minor
exceptions, few commenters expressed
complete opposition to the prohibition
on sewering. Furthermore, there was
widespread support from commenters
for applying the prohibition on sewering
hazardous waste pharmaceuticals to
healthcare facilities that are VSQGs. As
one commenter noted, ''given the large
number of small generators .
.
. If each
of these small generators were allowed
to discharge even a small amount of
pharmaceuticals, the overall volume
would be significant.
''
285
D. Final Rule Provisions
Given the environmental concerns
described above combined with the
overwhelming support that we received
from commenters, we are finalizing the
prohibition of sewering hazardous waste
pharmaceuticals. The prohibition on
sewering hazardous waste
pharmaceuticals applies to all reverse
distributors and all healthcare facilities,
including healthcare facilities that are
VSQGs. Furthermore, EPA is not
providing any exceptions to the
prohibition on sewering. Therefore, the
prohibition on sewering hazardous
waste pharmaceuticals applies to all
hazardous waste pharmaceuticals that
are generated by any healthcare
facilities and reverse distributors,
including hazardous waste
pharmaceuticals that are also controlled
substances and any pharmaceutical
wastage from partial administration of
hazardous waste pharmaceuticals. How
the sewer prohibition intersects with the
disposal of pharmaceutical wastage will
be discussed in greater detail in section
XIV.D.2. rather than this section.
In response to commenters'
suggestions, we are making some minor
editorial changes, including adding two
cross references to the CWA
prohibitions on sewering hazardous
wastes in §
403.5(b). One cross reference
will be added to §
261.4(a)(1)(ii) and the
other cross reference will be added to
§
266.505. We also eliminated the
second sentence of the proposed
prohibition, which read: The exclusion
in §
261.4(a)(1)(ii) for mixtures of
domestic sewage and other wastes that
pass through a sewer system to a
publicly owned treatment works does
not apply to hazardous waste
pharmaceuticals.
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See commenter number EPA-HQ-RCRA-
2007-0932-0231.
287
The NRC regulates radioactive wastes
generated by commercial or non-DOE facilities,
whereas DOE regulates radioactive wastes generated
by DOE facilities.
288
https://www.fda.gov/downloads/Drugs/
ResourcesForYou/Consumers/BuyingUsing
MedicineSafely/EnsuringSafeUseofMedicine/
SafeDisposalofMedicines/UCM337803.pdf.
289
https://www.fda.gov/Drugs/ResourcesForYou/
Consumers/BuyingUsingMedicineSafely/
EnsuringSafeUseofMedicine/SafeDisposal
ofMedicines/ucm186187.htm.
290
See 40 CFR 261.23(a)(2).
291
See 40 CFR 261.23(a)(3).
292
See 40 CFR 403.5(b)(7).
293
See comment number EPA-HQ-RCRA-2007-
0932-0230.
Oklahoma Department of
Environmental Quality (OK DEQ)
expressed concern that this ''second
sentence could be interpreted that EPA
is exerting RCRA authority over
domestic sewage if it contains
[hazardous waste pharmaceuticals]-an
area that has been exclusively under
Clean Water Act jurisdiction since the
first regulations were promulgated in
1980.''
286
EPA had proposed the second
sentence in an attempt to be abundantly
clear that the proposed prohibition on
sewering hazardous waste
pharmaceuticals supersedes the
exclusion in §
261.4(a)(1)(ii). We did not
intend to assert RCRA jurisdiction over
domestic sewage; therefore, we have
concluded that it is better to remove the
sentence in order to avoid the concern
expressed by OK DEQ. Nevertheless, we
wish to emphasize that the prohibition
on sewering hazardous waste
pharmaceuticals being finalized in
§
266.505 does, in fact, supersede the
exclusion in §
261.4(a)(1)(ii). To make
that point clear, we are amending
§
261.4(a)(1)(ii) to state that any mixture
of domestic sewage and other wastes
that passes through a sewer system to a
publicly-owned treatment works for
treatment, except as prohibited by
§§
266.505 and Clean Water Act
requirements at 40 CFR 403.5(b), is not
a solid waste.
E. Comments and Responses
Many comments suggested various
ways in which we should broaden the
applicability of the prohibition on
sewering hazardous waste
pharmaceuticals. In some cases,
commenters urged us to apply the
prohibition to all pharmaceuticals, not
just hazardous waste pharmaceuticals.
Subtitle D of RCRA, which governs the
management of non-hazardous (solid)
waste, does not provide EPA the
statutory authority to apply the
prohibition to non-hazardous waste
pharmaceuticals. Nevertheless, EPA
strongly recommends against sewering
any pharmaceuticals. The American
Water Works Association asked us to
extend the prohibition to prevent the
sewering of pharmaceuticals that are
radioactive and patient waste containing
radioactive pharmaceuticals. As
discussed previously, hazardous waste
pharmaceuticals that also contain a
radioactive component subject to the
Atomic Energy Act of 1954 (i.e., ''mixed
waste'') are regulated by multiple
agencies. The hazardous waste
component is regulated under EPA or
the authorized state RCRA programs,
while either the NRC or the Department
of Energy regulates the radioactive
component of the waste under the
Atomic Energy Act.
287
Therefore, a
''mixed waste'' pharmaceutical that is
both radioactive and RCRA hazardous
waste is prohibited from being
discharged to the sewer. We strongly
recommend against sewering other
radioactive pharmaceuticals and patient
waste containing radioactive
pharmaceuticals.
Other commenters suggested that the
prohibition should not be limited to
discharges to POTWs; rather, it should
also apply to discharges to septic tanks,
privately owned treatment works and
federally owned treatment works.
Section 261.4(a)(1)(ii) allows the
discharge of what would otherwise be a
hazardous waste to POTWs, without
being considered a solid or hazardous
waste. The prohibition on discharges of
hazardous waste pharmaceuticals being
finalized today is intended to reduce the
scope of that exclusion in the existing
regulations. Discharges of hazardous
waste to other types of sewage systems,
such as septic tanks, privately owned
treatment works and federally owned
treatment works are not allowed by
exclusion in §
261.4(a)(1)(ii). Therefore,
the discharge of hazardous wastes to
septic tanks, privately owned treatment
works and federally owned treatment
works is already prohibited, even
though it is not explicitly stated.
We note that although our RCRA
statutory authority limits us to apply the
prohibition on sewering narrowly to
pharmaceuticals that are RCRA
hazardous wastes, EPA strongly
recommends as a best management
practice to not sewer any waste
pharmaceutical (i.e., hazardous or non-
hazardous) from any source or location.
This recommendation against sewering
pharmaceuticals includes households
and assisted living facilities, except in
the relatively rare situation when
households and assisted living facilities
are specifically directed by FDA
guidance to flush certain potentially
dangerous drugs down the toilet (as
noted on pharmaceutical packaging),
when a drug take-back option is not
readily available, to help ensure that
they are not misused or accidentally
ingested or touched.
288
In lieu of
sewering, we recommend that
households, including residents of
assisted living facilities, follow the
guidelines developed by the U.S. Office
of National Drug Control Policy
(ONDCP), the FDA, and EPA for the
disposal of unwanted household
pharmaceuticals. In summary, the
guidelines for households disposing of
pharmaceuticals are as follows (in order
of preference):
(1) Use a drug take-back event or
program, when available;
(2) Dispose in household trash, after
mixing the unwanted medicines with an
unpalatable substance such as dirt, cat
litter, or used coffee grounds and
placing in a sealed container; and
(3) Only if the drug label specifically
instructs you to, flush the unwanted
medicine down the toilet.
289
We also note that the CWA
prohibitions on discharges of hazardous
waste in §
403.5(b) are broader than just
pharmaceuticals and apply beyond
healthcare facilities and reverse
distributors. Like all of the prohibited
discharges under the CWA regulations,
the prohibitions of hazardous waste
discharges apply to any industrial user.
Additionally, the CWA prohibitions on
hazardous waste discharges apply to all
D001 ignitable liquids, acidic D002
hazardous wastes, and D003 reactive
hazardous wastes that (1) react violently
with water,
290
(2) form potentially
explosive mixtures with water,
291
or (3)
result in the presence of toxic gases,
vapors or fumes within the POTW in a
quantity that may cause acute worker
health and safety problems,
292
not just
pharmaceuticals that exhibit those
characteristics.
Some commenters asked us to include
some exceptions to the prohibition on
discharges of hazardous waste
pharmaceuticals. Specifically, one
commenter who supported our
proposed ban on sewering of hazardous
waste pharmaceuticals, and even
supported extending it to non-
hazardous waste pharmaceuticals,
suggested that we allow exceptions ''for
those that do not contain active
pharmaceutical ingredients, such as
sterile water and 0.9% sodium chloride
for injection and irrigation.''
293
First, as
a point of clarification, because sterile
water and 0.9% sodium chloride are not
hazardous waste, they would not be
subject to the prohibition of discharging
hazardous waste pharmaceuticals to the
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See comment number EPA-HQ-RCRA-2007-
0932-0296.
295
See comment number EPA-HQ-RCRA-2007-
0932-0341.
296
See comment number EPA-HQ-RCRA-2007-
0932-0248.
297
See comment number EPA-HQ-RCRA-2007-
0932-0341.
298
See comment number EPA-HQ-RCRA-2007-
0932-0249.
sewer. And even though, as a general
rule, we strongly recommend against
sewering any pharmaceutical, regardless
of whether it meets our definition of
hazardous waste, we agree with the
commenter that it seems unnecessary to
prohibit the sewering of sterile water
and 0.9% sodium chloride.
Other commenters asked us to make
other exceptions to the prohibition on
discharging hazardous waste
pharmaceuticals. For example, the
Healthcare Waste Institute suggested
that we allow the discharge of
hazardous waste pharmaceuticals that
are specifically allowed by the local
wastewater treatment agency or
POTW.
294
CT DEEP made a similar
suggestion, saying that we should allow
discharges if they are ''explicitly
authorized by a National Pollutant
Discharge Elimination System (NPDES)
or State pretreatment permit.''
295
We
have concluded that such an allowance
is unnecessary because no known
pretreatment standards or local limits
have been established that specifically
allow for the discharge of any
pharmaceuticals. Note that 40 CFR part
439 separately regulates discharges from
pharmaceutical manufacturers to
POTWs and waters of the U.S.
Furthermore, in the absence of water
quality standards for specific drugs, we
would like to avoid a situation where
local wastewater treatment agencies
might feel pressured to make judgments
on which discharges would be
acceptable without knowing the effects
on aquatic life or the synergistic effects
of multiple drugs.
We received few comments related to
our inquiry about trade-offs inherent in
prohibiting sewer disposal. Sharps
Compliance did note that as ''our
experience as a DEA authorized
collector has shown, regulations that
ban the sewering in conjunction with a
proactive collection and destruction
program offer the best protection against
both environmental harm and the risk of
diversion.''
296
In addition, CT DEEP
commented they do ''not believe there
is an unfavorable risk trade-off inherent
in prohibiting sewer disposal,''
indicating both risks are manageable.
297
Eli Lilly was one of the few
commenters that opposed the
prohibition on sewering hazardous
waste pharmaceuticals, even though, as
a manufacturer, they are not subject to
the prohibition.
298
They expressed two
reasons for their opposition: (1) They do
not believe that a total prohibition is
based on sound risk management
decisions and should be more flexible to
exclude pharmaceuticals which FDA
says should be disposed of down the
drain, and (2) they believe that an
effluent guideline under the CWA
regulations is more appropriate and that
EPA's Office of Water has decided not
to promulgate an effluent guideline for
the healthcare industry. As discussed
previously, the prohibition on sewering
hazardous waste pharmaceuticals and
the FDA flush list do not conflict with
one another. The prohibition applies to
healthcare facilities (which does not
include assisted living facilities) and
reverse distributors, while the FDA
flush list is directed to households and
assisted living facilities and includes
the caveat that flushing takes place only
when a drug take-back option is not
readily available. As to the commenter's
second point, while it is true that the
Office of Water has not yet promulgated
an effluent guideline for the healthcare
industry, this should not be taken as a
sign that a decision has been made
affirmatively that an effluent guideline
is not appropriate at some time in the
future. Rather, the Office of Water has
preferred that the Office of Resource
Conservation and Recovery (ORCR) first
focus on preventing intentional
discharges of hazardous waste
pharmaceuticals. We firmly believe that
the prohibition of sewering hazardous
waste pharmaceuticals would
complement any future action taken by
the Office of Water to issue effluent
guidelines for the healthcare industry.
XIV. Conditional Exemptions for
Hazardous Waste Pharmaceuticals That
Are Also Drug Enforcement
Administration Controlled Substances
and Household Waste Pharmaceuticals
Collected in Take-Back Programs
(§
266.506)
A. Summary of Proposal
Prior to this final rulemaking, the
management and disposal of a
pharmaceutical that was both a RCRA
hazardous waste and a DEA controlled
substance was regulated under both the
RCRA Subtitle C hazardous waste
regulations, which is under EPA's or the
authorized state's purview, and the
Controlled Substances Act and its
implementing regulations, which is
under DEA's purview. At the time of the
proposal, EPA was aware of only a
handful of pharmaceuticals in common
usage that are both hazardous waste and
controlled substances and therefore
subject to regulation by both EPA and
the DEA. These are identified in Table
3:
TABLE
3-PHARMACEUTICALS
STILL
USED
IN
HEALTHCARE
THAT
ARE
DEA CONTROLLED
SUBSTANCES
AND
RCRA
HAZARDOUS
WASTES
Name of drug Other name(s) Medical uses RCRA HW code
DEA CS
schedule
Comment
Chloral; chloral hy-
drate.
Acetaldehyde, trichloro-; Aquachloral,
Noctec, Somnote, Supprettes.
Sedative
.................
U034, toxic
.............
IV Used in hospital pe-
diatric units; com-
mon ingredient in
vet anesthetics.
Fentanyl sublingual
spray.
Subsys
....................................................
Analgesic
................
D001, ignitable
.......
II Ignitable due to al-
cohol content.
Phenobarbital
...........
Bellergal-S, Donnatal, Luminal,
..............
Anticonvulsant
........
D001, ignitable
.......
IV Ignitable due to al-
cohol content.
Testosterone gels
....
Androgel, Fortesta, Testim
.....................
Hormone
.................
D001, ignitable
.......
III Ignitable due to gel
base.
Valium injectable
.....
Diazepam
................................................
Anti-anxiety
.............
D001, ignitable
.......
IV Ignitable due to al-
cohol content.
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299
Note that EPA's U034 listing includes chloral
hydrate, see memo dated April 6, 1998; Brandes to
Knauss, RCRA Online #14175
300
See memo dated February 17, 2012; from
Devlin to RCRA Division Directors, RCRA Online
#14831.
Chloral hydrate (U034), which is
listed for toxicity, is the only dually
regulated hazardous waste/controlled
substance that is a listed hazardous
waste.
299
The other four dually
regulated hazardous wastes/controlled
substances in common use are
considered hazardous because they
exhibit the characteristic of ignitibility
(D001). While the active ingredient is
not ignitable, these particular forms of
the pharmaceuticals are ignitable
because they are prepared in ignitable
solutions, such as alcohol.
EPA is aware of three additional
hazardous waste pharmaceuticals that
are DEA controlled substances, but it is
our understanding that they are no
longer in common usage, although there
may be legacy supplies remaining in
healthcare facilities. See Table 4.
TABLE
4-DEA CONTROLLED
SUBSTANCES
AND
RCRA HAZARDOUS
WASTES
PHARMACEUTICALS
THAT
ARE
NOT
IN
COMMON
USE
Name of drug Other name(s) Medical uses RCRA HW code
DEA CS
schedule
Comment
Paraldehyde
.............
1,3,5-Trioxane, 2,4,6-trimethyl-; Paral
....
Anticonvulsant
........
U182
toxic
.............
IV No longer in com-
mon use.
Paregoric
.................
camphorated tincture of opium
...............
Analgesic, expecto-
rant, antidiarrheal.
D001 ignitable
........
III No longer in com-
mon use.
Opium Tincture
........
Laudanam
...............................................
Analgesic,
...............
antidiarrheal
............
D001 ignitable
........
II No longer in com-
mon use.
Similarly, as noted in Table 5,
phentermine is a controlled substance,
but the medical form is a phentermine
salt, and the salts are no longer
considered to be within the scope of the
P046 listing.
300
TABLE
5-PHARMACEUTICALS
THAT
ARE
DEA CONTROLLED
SUBSTANCES
AND
RCRA HAZARDOUS
WASTES
SALT(S) NO
LONGER
CONSIDERED
HAZARDOUS
WASTE
Name of drug Other name(s) Medical uses RCRA HW code
DEA CS
schedule
Comment
Phentermine
............
alpha, alpha-Dimethylphenethyl amine;
Benzeneethanamine, alpha,alpha-di-
methyl-; Adipex-P, Atti Plex P, Fastin,
Ionamin, Kraftobese, Panshape M,
Obe-Nix, Pentercot, Phentride, Pro-
Fast, Raphtre, Supramine, Tara-8,
Termene, Termine, Zantryl.
Appetite suppres-
sant.
P046, Acutely toxic IV If in salt form, it
does not meet the
P046 listing and
medical dosage
forms are salts.
EPA requested comment on whether
these are, indeed, the only
pharmaceuticals in common usage that
are regulated both as DEA controlled
substances, and when discarded, as
RCRA hazardous waste.
To eliminate duplicative regulation
for these handful of hazardous wastes
that are also controlled substances, EPA
proposed to conditionally exempt from
RCRA Subtitle C regulation those
hazardous wastes that are also DEA
controlled substances. Specifically, EPA
proposed that hazardous wastes that are
also controlled substances will be
exempt from all RCRA Subtitle C
requirements, including 40 CFR part
266 subpart P, provided they meet two
conditions: (1) They are combusted at a
permitted large or small municipal
waste combustor or a permitted or
interim status hazardous waste
combustor (incinerator or cement kiln)
and (2) they are managed and disposed
of in compliance with all applicable
DEA regulations for controlled
substances.
The first condition we proposed was
to ensure that the controlled substances
are destroyed in an environmentally
protective manner by a high-
temperature combustor, such as a large
or small municipal waste combustor or
a permitted or interim status hazardous
waste combustor (incinerator or cement
kiln). At the time of proposal, DEA had
not specified or endorsed a method by
which the controlled substances should
be destroyed to meet the non-retrievable
standard. Although many hazardous
wastes/controlled substances were being
destroyed by incineration, it was not
required by DEA. At the time, EPA was
concerned that in the future DEA might
allow a technology that lacks
environmental controls and permits.
Therefore, combustion of the hazardous
wastes/controlled substances, which
requires permitting, operating and
monitoring standards, was proposed as
a condition of the exemption. However,
EPA requested comment on whether
there are additional technologies that
would be appropriate to include for the
destruction of hazardous waste
pharmaceuticals that are also controlled
substances.
The second condition we proposed
was to ensure that dually regulated
hazardous wastes/controlled substances
are managed under another rigorous
regulatory program since they will not
be managed in accordance with the
RCRA Subtitle C regulations. Although
developed for different reasons, both
EPA's hazardous waste and DEA's
controlled substance regulatory
programs are designed to track the
regulated material from cradle to grave.
EPA requested comment on whether the
tracking that DEA requires for
controlled substances is sufficient to act
in lieu of the RCRA manifest.
We considered proposing a third
condition that the hazardous waste
pharmaceuticals that are also DEA
controlled substances would be subject
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See memo from J. Winston Porter to Regions,
dated November 1, 1988; RCRA Online #11377.
302
See memo September 26, 2012, Rudzinski to
the Regional RCRA Division Directors (RCRA
Online#14833) and memo October 2, 2015, Johnson
to RCRA Division Directors (RCRA Online #14853).
303
Since pharmaceutical collection programs
typically commingle DEA controlled substances
with non-controlled substances, this requirement is
included in a section of the regulations that pertains
to controlled substances.
304
DEA does not prohibit co-mingling of
controlled substances with non-controlled
substances provided they are all then managed as
controlled substances.
305
See 40 CFR 26.506(a)(2).
306
See Comment number EPA-HQ-RCRA-2007-
0932-0287.
307
See Comment number EPA-HQ-RCRA-2007-
0932-0375.
308
See Comment number EPA-HQ-RCRA-2007-
0932-0333.
309
See comment number EPA-HQ-RCRA-2007-
0932-0261.
to the sewer prohibition of §
266.505. At
the time of proposal, however, we
concluded that because combustion in
specific units was a condition of the
exemption, that it was unnecessary to
state that the hazardous waste/
controlled substances may not be
sewered.
EPA also proposed a related
conditional exemption for household
pharmaceuticals, including those that
are collected in DEA authorized
collection receptacles and commingled
with DEA controlled substances.
Specifically, we proposed that collected
household pharmaceuticals will
continue to be excluded from RCRA
regulation as household hazardous
waste, provided they comply with the
same two conditions. The Agency has a
long-standing recommendation that
household hazardous waste collection
programs manage the collected waste as
hazardous waste.
301
As such, the
Agency recommends that collected
household waste pharmaceuticals be
incinerated-preferably at a permitted
hazardous waste incinerator, but when
that is not feasible, at a large or small
municipal waste combustor.
302
The
Agency believes that this practice is
already common among collection
programs since one goal of many
collection programs is to divert
pharmaceuticals from municipal
landfills. Additionally, incineration is
commonly used to meet the ''non-
retrievable'' standard of destruction
required by DEA for controlled
substances collected from consumers
(ultimate users, as DEA refers to them).
Nevertheless, the Agency proposed to
make this recommendation a
requirement for collected household
waste pharmaceuticals in §
266.506.
303
We strongly believe that if a program
goes to the expense of collecting the
waste, including waste pharmaceuticals,
it should manage the waste as
hazardous waste, rather than manage it
as municipal solid waste, which the
household could do absent the
collection program. However, the
current household waste exemption
does not require an entity that hosts a
household hazardous waste collection
event to manage the collected waste as
hazardous waste. Typically, the parties
conducting household hazardous waste
collection events have been government
entities-municipalities and counties. It
is relatively new that retail pharmacies
and others are becoming interested in
performing this function. To encourage
this practice, while at the same time
ensuring that collection programs are
managing the collected waste properly,
we proposed to codify our policy that
pharmaceuticals that are household
hazardous waste (i.e., ''household waste
pharmaceuticals'') and are collected in
DEA authorized collection receptacles
where they may be commingled
304
with
controlled substances continue to be
excluded from RCRA regulation,
provided they are (1) combusted at a
municipal solid waste or hazardous
waste combustor, and (2) managed in
accordance with all applicable DEA
regulations.
305
B. Summary of Comments
Many of the commenters, including
states, healthcare facilities, and waste
management companies, supported both
conditional exemptions as a way to
eliminate the duplicative regulation by
DEA and EPA and commenters thought
that the DEA tracking, shipping and
recordkeeping are sufficient to operate
in lieu of RCRA. Several commenters
suggested that we expand the types of
treatment that are allowed to destroy the
hazardous waste pharmaceuticals that
are also controlled substances. In some
cases, commenters suggested that we
allow additional combustion units such
as hospital, medical, infectious waste
incinerators (HMIWIs); commercial,
industrial solid waste incinerators
(CISWIs); and other solid waste
incinerators (OSWIs) to combust
hazardous waste pharmaceuticals that
are also controlled substances. Other
commenters suggested that we allow
forms of destruction beyond
combustion, such as oxidation
treatment
306
or chemical digestion,
307
or
any technology that achieves DEA's
standard of non-retrievable.
308
C. Final Rule Provisions
We are finalizing both conditional
exemptions for hazardous wastes that
are also controlled substances, with
some changes. First, we have amended
the regulatory language in
§
266.506(a)(2) to be more consistent
with the preamble to the proposed
rulemaking and to be more consistent
with how the conditional exemption in
§
266.506(a)(1) was crafted. In the
preamble to the proposed rulemaking,
we discussed the conditional exemption
in terms of the waste pharmaceuticals
from take-back events and programs,
while in the proposed regulatory
language, the conditional exemption
was focused on the collector of the
waste pharmaceuticals. We revised the
regulatory language in §
266.506(a)(2) to
conditionally exempt the collected
household waste pharmaceuticals, as
opposed to the collector of the
household waste pharmaceuticals.
Additionally, one commenter pointed
out that the proposed regulatory
language could be read to mean that if
the household waste pharmaceuticals
were not commingled with DEA
controlled substances, then the
requirement to combust them would not
apply.
309
EPA did not intend to make
this distinction. Although we
understand that most, if not all, take-
back events and programs do, in fact,
commingle controlled substances with
non-controlled substances, EPA
proposed to place conditions on
collectors of household waste
pharmaceuticals with the understanding
that this proposed regulatory language
would capture all pharmaceuticals
collected at take-back events and
programs. The revised regulatory
language in this final rule makes it
clearer that the household waste
pharmaceuticals collected during a take-
back event or program must be
destroyed by combustion or other DEA-
approved method, whether or not the
household waste pharmaceuticals are
commingled with DEA controlled
substances.
Also in response to comments, we are
expanding the types of combustors that
are allowed to destroy the conditionally
exempt hazardous waste
pharmaceuticals. Under the final rule,
five types of combustors will be allowed
to destroy hazardous waste
pharmaceuticals that are also DEA
controlled substances and the
pharmaceuticals from take-back events
and programs: (1) Permitted large
municipal waste combustors (MWCs),
(2) permitted small MWCs, (3) permitted
HMIWIs, (4) permitted CISWIs and (5)
permitted hazardous waste combustors
(either an incinerator or other
combustor, such as a cement kiln).
In addition to the five types of
permitted combustors allowed to
destroy the conditionally exempt
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Energy Recovery Council, 2016 Directory of
Waste-to-Energy Facilities; http://
energyrecoverycouncil.org/wp-content/uploads/
2016/06/ERC-2016-directory.pdf.
311
Memo from Rudzinski to Regions, dated
September 26, 2012; RCRA Online #14833.
312
See comment number EPA-HQ-RCRA-2007-
0932-0280.
313
See CISWI inventory EPA-HQ-OAR-2016-
0664-0002.
314
See comment number EPA-HQ-RCRA-2007-
0932-0250.
pharmaceuticals, EPA is building in
flexibility to the final regulation to
allow for the possibility that future
technologies might be developed that
meet the DEA non-retrievable standard.
Specifically, we are allowing any
method of destruction for the
conditional exemption that DEA has
publicly approved in writing as able to
meet its non-retrievable standard. While
it is reasonable to defer to the DEA's
judgement in this matter to approve
methods of destruction that are
environmentally protective, we feel it is
necessary to limit future allowable
destruction technologies for the
conditionally exempt pharmaceuticals
to those that are publicly approved by
the DEA as meeting the non-retrievable
standard. This is intended to avoid a
situation where parties might make
unsubstantiated claims that their
product is capable of meeting the DEA
non-retrievable standard in order to
qualify for the conditional exemption.
Furthermore, any method that DEA
might specify must not conflict with
federal environmental laws or
regulations. Also, because combustion is
no longer specified as the only
allowable method of destruction, we
have concluded that an additional
change to the regulations is needed to
make it clear that the hazardous waste
pharmaceuticals that are also DEA
controlled substances are subject to
§
266.505, and therefore, may not be
sewered.
Both types of conditionally exempt
hazardous waste pharmaceuticals (i.e.,
those that are DEA controlled
substances and those that are collected
household waste pharmaceuticals) will
be able to take advantage of the
expanded list of allowable types of
combustors. For healthcare facilities and
reverse distributors that generate and
manage the handful of hazardous waste
pharmaceuticals that are also controlled
substances, we think it will be helpful
to have additional destruction methods
for these previously dually regulated
wastes. Also, the expanded list of
allowable types of combustors will be
helpful for those operating take-back
programs and events. The Agency is a
strong supporter of take-back programs
and events for household
pharmaceuticals as an alternative to
disposing of leftover, unwanted
medications in the trash or in the toilet
or down the sink (except in cases where
the FDA-approved labeling instructs
patients to immediately flush the
unneeded medication down the toilet if
a take-back option is not readily
available). In expanding the types of
combustors that are allowed to burn the
pharmaceuticals from take-back events,
we strive to strike a balance between
maximizing flexibility while still being
protective of human health and the
environment. Under the revised list in
the final rule, the universe of allowable
combustors will substantially increase
in number. There are 77 municipal solid
waste combustion facilities (also
referred to as waste-to-energy facilities)
in 22 states,
310
and 21 commercial
hazardous waste combustion facilities
(i.e., those that accept waste from off-
site) in 12 states.
311
There are currently
33 HMIWIs units in the U.S.: 11 of the
33 are commercial HMIWIs, while the
other 22 HMIWI units only combust
their own waste.
312
There are
approximately 75 CISWIs facilities in
the U.S.
313
We note that the types of
combustors we are allowing to accept
the conditionally exempt
pharmaceuticals are not obligated to
accept the conditionally exempt
pharmaceuticals. Of course, we strongly
encourage all the various types of
allowable combustors to work with their
communities and regulators in
developing viable options for destroying
the pharmaceuticals from take-back
events. In particular, we encourage the
''captive'' combustors that currently
only combust their own waste to
consider amending their permits to
allow them to accept pharmaceuticals
from take-back events and programs.
We have concluded that it is
reasonable to expand the list of
allowable combustors able to accept the
conditionally exempt pharmaceuticals
because the combustion of
pharmaceuticals that meet the definition
of a RCRA solid waste but do not meet
the definition of RCRA hazardous waste
(i.e., non-hazardous waste
pharmaceuticals) is regulated by §
129
of the Clean Air Act. The statute
requires EPA to establish emission
limits for nine air pollutants (i.e.,
particulate matter, carbon monoxide,
dioxins/furans, sulfur dioxide, nitrogen
oxides, hydrogen chloride, lead,
mercury, and cadmium) from several
categories of solid waste incineration
units, including MWCs; HMIWIs; and
CISWIs. EPA has established emission
limits for each of the categories based on
the application of maximum available
control technology (MACT) which
reflect the emission levels achieved by
the best performers in each category.
In addition to complying with
emission limitations, solid waste
incineration units are also subject to
comprehensive operating, monitoring
and reporting requirements. In light of
the common framework used to develop
emission limits and requirements for
MWC, CISWI, and HMIWI units, we
believe that it is appropriate to include
HMIWIs and CISWIs as types of
combustors that are allowed to burn the
pharmaceuticals from take-back events.
While the Agency has expanded the
list of allowable combustors to include
HMIWIs and CISWIs, we have not
expanded the list to include other solid
waste incinerators (OSWIs). OSWIs are
small units that have fewer emission
controls than other types of combustors.
Further, there are only a handful of new
OSWIs in operation and the legal status
of existing OSWIs is uncertain due to
litigation. EPA is also not expanding the
list of allowable combustors to include
human and pet crematoriums.
Crematoriums are not regulated under
the Clean Air Act and typically do not
use air pollution control devices to limit
toxic air pollutants such as mercury and
dioxins and furans. We believe that
crematoriums would not provide
adequate public health and
environmental protection when burning
non-hazardous waste pharmaceuticals.
If solid or hazardous wastes are burned
in a crematorium, it would make the
crematorium subject to the Clean Air
Act.
D. Comments and Responses
In its comment, Cardinal Health
included a list of pharmaceuticals that
it manages as both RCRA hazardous
waste and DEA controlled
substances.
314
In most cases, their
comments reinforced the list that we
included in the proposed rulemaking. In
two cases, Cardinal Health identified
additional forms of drugs that were
included in the table of DEA controlled
substances and hazardous wastes in the
preamble to the proposed rulemaking.
First, Cardinal Health identified Axiron
as the brand name of an additional form
of testosterone that is a solution applied
to the underarms that is also ignitable.
Second, Cardinal Health identified
Diastat as the brand name of an
additional form of valium that is a gel
intended for rectal administration that is
also ignitable. We have amended our list
of DEA controlled substances and RCRA
hazardous wastes by including Axiron
and Diastat in Table 6 below to be more
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The Anabolic Steroids Control Act of 1990
placed anabolic steroids into Schedule III of the
Controlled Substances Act (CSA) as of February 27,
1991.
316
https://www.fda.gov/Drugs/DrugSafety/
ucm237839.htm; accessed 8/24/2017.
317
DEA also prohibits retail pharmacy stock/
inventory from being placed in the collection
receptacle or mail-back envelopes (see 21 CFR
1317.05(a)).
318
See the preamble to DEA's final rule 79 FR
53548; September 9, 2014 and the preamble to
DEA's proposed rule 77 FR 75803; December 21,
2012.
319
See the Clean Water Act regulations at 40 CFR
403.5(b)(1).
complete and accurate. However, there
is no corresponding regulatory change
being made. The regulations
conditionally exempt all RCRA
hazardous wastes that are also DEA
controlled substances; the table
identifying which drugs are both is
included in the preamble for
informational purposes:
TABLE
6-PHARMACEUTICALS
STILL
USED
IN
HEALTHCARE
THAT
ARE
DEA CONTROLLED
SUBSTANCES
& RCRA
HAZARDOUS
WASTES
[Amendments in bold based on comments]
Name of drug Other name(s) Medical uses RCRA HW code
DEA CS
schedule
Comment
Chloral; chloral hy-
drate.
Acetaldehyde, trichloro-; Aquachloral,
Noctec, Somnote, Supprettes.
Sedative
.................
U034 toxic
..............
IV Used in hospital pe-
diatric units; com-
mon ingredient in
vet anesthetics.
Fentanyl sublingual
spray.
Subsys
....................................................
Analgesic
................
D001 ignitable
........
II Ignitable due to al-
cohol content.
Phenobarbital
...........
Bellergal-S, Donnatal, Luminal,
..............
Anticonvulsant
........
D001 ignitable
........
IV Ignitable due to al-
cohol content.
Testosterone gels/
solutions.
Androgel, Axiron, Fortesta, Testim
.........
Hormone
.................
D001 ignitable
........
III Ignitable due to al-
cohol content.
Valium injectable/gel Diazepam, Diastat
...................................
Anti-anxiety
.............
D001 ignitable
........
IV Ignitable due to al-
cohol content.
Cardinal Health's comment also
indicated that the company manages
Somatropin (brand names Humatrope
and Genotropin) as a DEA controlled
substance and a RCRA hazardous waste.
M-cresol, which is a contaminant
identified on the toxicity characteristic
list in §
261.24 (D024), is used as a
preservative in Somatropin. Per
legislations, all anabolic steroids are
considered controlled substances;
315
however, Somatropin is considered a
human growth hormone, not an
anabolic steroid.
316
Therefore, although
Somatropin may be a RCRA hazardous
waste for its m-Cresol content, it is not
a DEA controlled substance.
The two conditional exemptions we
are finalizing in this rule are intended
to eliminate any duplicative regulations
for pharmaceuticals that are RCRA
hazardous wastes and DEA controlled
substances. Nevertheless, there are
several remaining areas where DEA and
EPA regulations intersect, even if they
are not duplicative. The Agency would
like to address these intersecting areas
in effort to reduce confusion and aid
compliance.
1. Only Household (Ultimate User)
Waste May Be Collected in DEA
Authorized Collection Receptacles
It is important to note that in order to
qualify for the conditional exemption, a
retail pharmacy (or other DEA
authorized collector pharmacy) can use
the DEA authorized collection
receptacle to collect waste generated
only at households (DEA refers to this
as waste from ''ultimate users'') and
brought to the store for collection. The
hazardous waste generated by the retail
pharmacy and store, including
hazardous waste pharmaceuticals, are
not excluded household wastes under
RCRA and may not be placed in the
DEA authorized receptacle.
317
Depending on the amount generated, the
hazardous waste pharmaceuticals
generated by the retail pharmacy and
store must be managed under either
§
262.14 (as a VSQG) or under part 266
subpart P. Furthermore, states generally
regulate non-hazardous waste and it is
possible that they may have licensing or
permitting requirements for the
collection of solid waste. Because EPA
would like to see the use of DEA
authorized collection receptacles
become widespread, we encourage
states to streamline any requirements
that may create a barrier to the use of
the DEA authorized collection
receptacles.
2. Sewer Prohibition, Conditional
Exemption and Pharmaceutical Wastage
In response to comments, EPA has
decided against making any exceptions
to the sewer prohibition. Some
commenters suggested that EPA should
allow RCRA hazardous wastes that are
also DEA controlled substances to be
sewered. On the other hand, many
commenters suggested, and EPA agrees,
that it would be inappropriate to make
exceptions to the sewer prohibition,
even for the handful of hazardous
wastes that are also controlled
substances. In part, commenters thought
it was bad environmental policy to
allow sewering of any hazardous waste
pharmaceuticals. Commenters were also
concerned that it would send a mixed
message to the regulated community
about our goals and lead to confusion
about which hazardous waste
pharmaceuticals could and could not be
sewered. As a result, all hazardous
waste pharmaceuticals are prohibited
from being sewered, including the
handful that are also DEA controlled
substances.
Under the DEA regulations, a
registrant's inventory of controlled
substances is already prohibited from
being sewered as a means of meeting the
non-retrievable standard.
318
Likewise,
under the CWA regulations, RCRA
ignitable hazardous wastes (D001) are
prohibited from being discharged to the
sewer.
319
As noted in Table 6, four out
of the five RCRA hazardous wastes that
are also DEA controlled substances are
hazardous waste due to being ignitable
and hence are already prohibited from
being sewered by the CWA regulations.
In effect, this new RCRA regulation only
prohibits the sewering of one additional
DEA controlled substance that is also a
RCRA hazardous waste: Chloral hydrate,
which is listed for toxicity. In summary,
a RCRA hazardous waste that is also
DEA controlled substance that is part of
a DEA registrant's inventory may not be
sewered.
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320
See DEA letter to registrants re: Clarifying
disposal of pharmaceutical wastage dated Oct 17,
2014; http://www.deadiversion.usdoj.gov/drug_
disposal/dear_practitioner_pharm_waste_
101714.pdf.
321
Ibid.
322
Ibid.
323
See 40 CFR 266.504(d).
DEA does allow controlled substance
''pharmaceutical wastage'' to be
disposed of in accordance with
applicable federal, state, and local laws,
regulations, and healthcare facility
policies, including sewering or putting
down the drain.
320
DEA uses the term
''pharmaceutical wastage'' to refer to
leftover, unadministered
pharmaceuticals (''e.g., some of the
substance remains in a vial, tube,
transdermal patch, or syringe after
administration but cannot or may not be
further utilized''
321
). While DEA allows
pharmaceutical wastage of controlled
substances to be sewered, the CWA
regulations already prohibit the
discharge of any RCRA ignitable
hazardous waste and, under this RCRA
rule, EPA is not creating any exceptions
to the sewer prohibition. As a result,
neither inventory nor pharmaceutical
wastage of DEA controlled substances
that are also RCRA hazardous wastes
may be sewered.
Even though inventory and
pharmaceutical wastage are prohibited
from being sewered, both inventory and
pharmaceutical wastage would be
eligible for the conditional exemption
being finalized in this rule in §
266.506
for RCRA hazardous wastes that are also
DEA controlled substances. As
discussed previously, EPA is finalizing
the conditional exemption that the few
RCRA hazardous waste pharmaceuticals
that are also DEA controlled substances
would be exempt from RCRA regulation,
on the condition that they are (1)
managed in accordance with DEA
regulations and (2) incinerated by one of
five types of permitted combustors or
destroyed by another method that has
been publicly approved by DEA, and (3)
are not sewered.
Therefore, if inventory or
pharmaceutical wastage is both a RCRA
hazardous waste and a DEA controlled
substance it would not be allowed to be
sewered, it would have to be incinerated
(or destroyed by another method
publicly approved by DEA). Prior to
incineration, however, the inventory
and pharmaceutical wastage, both of
which are conditionally exempt under
RCRA, are regulated differently by DEA.
The leftover inventory of DEA
controlled substances remains fully
subject to DEA regulations, which
includes tracking and witnessed
destruction. On the other hand,
controlled substance pharmaceutical
wastage is no longer regulated by DEA.
Therefore, only pharmaceutical wastage
could be collected in a container at the
healthcare facility prior to incineration.
If this container were used to collect
only conditionally exempt
pharmaceutical wastage prior to
incineration, it would not be subject to
the subpart P container standards. It is
more likely, however, that a container
used to collect the conditionally exempt
pharmaceutical wastage would also be
used to collect regulated hazardous
waste, in which case the container
would be subject to subpart P container
standards. In either case, as DEA states
in its guidance, ''Although Part 1317
does not apply to pharmaceutical
wastage, the DEA strongly encourages
all practitioners to continue to adhere to
security controls and procedures that
ensure pharmaceutical wastage is not
diverted. For example, most
institutional practitioners have
implemented policies that require two
persons to witness and record
destruction of pharmaceutical
wastage.''
322
In support of DEA's
guidance, EPA strongly recommends
that any container that is used to collect
pharmaceutical wastage that will
include DEA controlled substances
contain some sort of absorbent or
chemical reactant in order to bind or
chemically alter the contents and thus
deter the diversion of the collection
container for controlled substance
recovery.
3. Long-Term Care Facilities and the
DEA Regulations
This section will discuss the
intersection of the DEA regulations and
the RCRA hazardous waste regulations
that pertain to LTCFs.
Under the DEA regulations, most
LTCFs are not registrants and until
recently have had few options for
properly and securely disposing of the
controlled substances from its patients
(ultimate users). DEA's 2014 final
regulations to implement the Secure and
Responsible Drug Disposal Act of 2010
are designed to help alleviate the
problem that LTCFs face when
discarding their patients' controlled
substances. DEA's 2014 final rule
allows, but does not require, retail
pharmacies and hospital/clinics with an
on-site pharmacy that are DEA
registrants to modify their registrations
to become ''collectors'' and to place
collection receptacles at LTCFs (or at
the retail pharmacy or hospital/clinic
with an on-site pharmacy) for the
collection of controlled substances from
ultimate users. Per the DEA regulations,
if a DEA authorized collection
receptacle is placed in a LTCF, only the
ultimate users' controlled substances
may be placed in the DEA collection
receptacle. If an LTCF is a DEA
registrant and discards DEA controlled
substances from its inventory, they may
not be placed in the DEA authorized
collection receptacle and must be
otherwise destroyed to meet the non-
retrievable standard.
Under the 2014 DEA final rule, LTCFs
now have three options for managing
their patients' controlled substances.
First, if a DEA registered retail
pharmacy or hospital/clinic with an on-
site pharmacy places a collection
container at an LTCF, the staff from the
LTCF may place the patients' controlled
substances in the collection receptacles.
Second, although LTCFs are not allowed
to conduct a facility-wide collection
event for their patients' controlled
substances for mail-back programs, they
are allowed to assist patients who
choose to use a mail-back program for
their own controlled substances, on an
individual-by-individual basis. And
third, law enforcement can pick up
patients' controlled substances for
disposal. With these changes to DEA's
regulation, LTCFs can now dispose of
patients' controlled substances in a
more environmentally protective way
and EPA strongly encourages the use of
any of these three collection methods. It
should be noted that the 2014 DEA
regulations do not mandate the
placement of collection receptacles at
long-term care facilities or patient
participation in mail-back programs or
take-back events.
As for the RCRA regulations, this rule
finalizes the provision that hazardous
waste from LTCFs will no longer be
considered exempt as household
hazardous waste. Instead, it will need to
be managed as regulated hazardous
waste. This interpretation will apply to
all the hazardous waste generated by a
LTCF, not just its hazardous waste
pharmaceuticals (although the Agency
expects that much of the hazardous
waste generated by LTCFs consists of
hazardous waste pharmaceuticals).
Notwithstanding this revised
interpretation, there are four other
regulatory provisions that might affect
how a LTCF will actually have to
manage its hazardous waste
pharmaceuticals under this final rule
First, we have added to the final rule
a presumption that LTCFs with 20 beds
or fewer will be VSQGs.
323
And those
LTCFs that have more than 20 beds may
still qualify as VSQGs (for all of their
hazardous waste) if they generate less
than 100 kg of hazardous waste and less
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See the Regulatory Impact Analysis for this
final rule in the docket EPA-HQ-RCRA-2007-
0932.
325
See 40 CFR 266.502(l) and 266.503(b) for non-
creditable and creditable hazardous waste
pharmaceuticals, respectively.
than 1 kg of acute hazardous waste per
calendar month. In fact, based on the
RIA for the final rule, EPA estimates
that 98-99 percent of LTCFs that
generate hazardous waste are VSQGs.
324
As VSQGs, the long-term care facilities
will be subject to the reduced regulatory
provisions of 40 CFR 262.14 for all of
their hazardous waste (including those
that are controlled substances), and only
the sewer prohibition provision of this
new subpart for their hazardous waste
pharmaceuticals. Only the other 1-2
percent of LTCFs that generate
hazardous waste will be subject to part
266 subpart P.
Second, this final rule allows an LTCF
that is a VSQG (for all of its hazardous
waste) to send its hazardous waste
pharmaceuticals to an off-site healthcare
facility that either supplies the LTCF
with its pharmaceuticals (e.g., a long-
term care pharmacy) or is under the
control of the same person and that is
operating under subpart P.
325
Note that
this provision is limited to hazardous
waste pharmaceuticals and not to those
that are also controlled substances
because the DEA allows controlled
substances to be returned to a long-term
care pharmacy only when they are
subject to a recall.
Third, this final rule also allows a
healthcare facility, including a LTCF
that is a VSQG, to use an on-site DEA
authorized collection receptacle to
dispose of its hazardous waste
pharmaceuticals (see §
266.504(c)). It
could be argued that VSQGs would
already be allowed to use DEA
authorized collection receptacles for
their hazardous waste pharmaceuticals
even without this new provision,
provided the waste from the DEA
authorized collection receptacles is
treated or disposed at one of the types
of facilities identified in §
262.14(a)(5)
(e.g., facilities that are permitted or have
interim status to manage hazardous
waste and facilities that are permitted,
licensed or registered by a state to
manage hazardous waste, municipal
waste or non-municipal waste).
Nevertheless, we did propose, and are
finalizing the provision in §
266.504(c)
making it clear that healthcare facilities
that are VSQGs can place their
hazardous waste pharmaceuticals in an
on-site DEA collection receptacle. DEA
already allows controlled substances to
be commingled with non-controlled
substances. Therefore, EPA believes it is
consistent to allow VSQG hazardous
waste pharmaceuticals that are not
controlled substances to be placed in
DEA collection receptacles with
controlled substances. EPA believes that
management of VSQGs' hazardous
waste pharmaceuticals as DEA
controlled substances is preferable
because it provides greater protection to
patients, visitors, and workers at
healthcare facilities to have the
hazardous waste pharmaceuticals
accumulating in DEA-authorized
collection receptacles rather than in the
regular trash. However, it is important
to note that the DEA regulations for
controlled substances are much
narrower in what may be placed in a
collection receptacle; DEA only allows
controlled substances from patients to
be placed in collection receptacles that
are at LTCFs. To reiterate, under the
DEA regulations, if a LTCF, or any other
healthcare facility, is a DEA registrant it
may not place its own inventory of
controlled substances in a collection
receptacle, even if it is a VSQG under
RCRA.
Fourth, for the LTCFs that are not
VSQGs, the handful of RCRA hazardous
waste pharmaceuticals that are also DEA
controlled substances will not be subject
to RCRA, provided they meet three
conditions: (1) They are combusted at a
small or large MWC, a HMIWI, a CISWI
or a hazardous waste combustor (or
destroyed by another method publicly
approved by DEA), (2) they are managed
and disposed of in compliance with all
applicable DEA regulations for
controlled substances, and (3) they are
not sewered. DEA allows LTCFs to put
their patients' controlled substances
into an on-site collection receptacle;
therefore, an LTCF could also place its
patients' controlled substances that are
also RCRA hazardous waste into a DEA
authorized collection receptacle
(alternatively, patients could use
another allowable take-back method,
such as mail-back envelopes) in order to
meet the conditional exemption.
However, we must stress that only
LTCFs would be able to use collection
receptacles (or another allowable take-
back method) to meet the conditional
exemption for RCRA hazardous wastes
that are also DEA controlled substances,
because they are the only type of facility
that DEA allows to place their patients'
wastes into an on-site collection
container. Other healthcare facilities,
such as hospitals, could not meet the
conditional exemption by placing their
DEA controlled substances that are also
RCRA hazardous wastes in a collection
receptacle because DEA does not allow
patients at hospitals to use on-site
collection receptacles. No registrant
healthcare facility, including an LTCF,
would be able to use the collection
receptacle to meet the terms of the
conditional exemption for any of its
own inventory of DEA controlled
substances that are also RCRA
hazardous wastes because DEA does not
allow registrants to use collection
receptacles for their own inventory.
For those LTCFs that are not VSQGs,
the hazardous waste pharmaceuticals
that are not controlled substances (and
therefore not conditionally exempt) will
be subject to part 266 subpart P, while
the other hazardous wastes will be
subject to the SQG or LQG regulations,
as applicable, in part 262.
See Table 7 for a summary of the
intersection of RCRA and DEA
regulations for the disposal of hazardous
waste pharmaceuticals at LTCFs:
TABLE
7-INTERSECTION
OF
RCRA & DEA REGULATIONS
AT
LONG-TERM
CARE
FACILITIES
Types of pharmaceutical waste at long-term
care facilities
RCRA regulatory requirements
How RCRA applies
DEA authorized collection
methods allowed for HW
pharmaceuticals?
Can be returned to an off-site
HCF owned by the same
person or LTC pharmacy?
Hazardous Waste Pharmaceuticals that are
NOT Controlled Substances:
if LTCF is a VSQG
....................................
§
262.14 and sewer prohibi-
tion.
Yes. §
266.504(c)
...................
Yes.
if LTCF is not a VSQG
..............................
part 266 subpart P
.................
No
...........................................
No.
Hazardous Waste Pharmaceuticals that are
also Controlled Substances:
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Additionally, acute hazardous wastes are
included on the F-list of §
261.31; however, none
of those acute hazardous wastes are
pharmaceuticals.
327
We are assuming that containers that hold
pharmaceuticals are in containers less than 119
gallons in size.
328
Rudzinski to RCRA Division Directors,
November 11, 2011, RCRA Online #14827.
TABLE
7-INTERSECTION
OF
RCRA & DEA REGULATIONS
AT
LONG-TERM
CARE
FACILITIES-Continued
Types of pharmaceutical waste at long-term
care facilities
RCRA regulatory requirements
How RCRA applies
DEA authorized collection
methods allowed for HW
pharmaceuticals?
Can be returned to an off-site
HCF owned by the same
person or LTC pharmacy?
if LTCF is a VSQG
....................................
§
262.14 and sewer prohibi-
tion.
Yes. Only from patients
..........
Only if subject to a recall.
if LTCF is not a VSQG
..............................
Conditionally exempt from
RCRA (§
266.506) if:
.
Combusted (or other
DEA approved destruc-
tion method).
Yes. Only from patients (DEA
collection methods meet the
terms of the RCRA condi-
tional exemption).
Only if subject to a recall.
.
Comply with DEA regu-
lations.
XV. Management of Residues in
Pharmaceutical Containers (§
266.507)
A. Regulatory Background
Over the years, EPA has received
numerous inquiries regarding the
regulatory status of residues in various
types of containers that once held
pharmaceuticals that are considered
hazardous waste when discarded.
Stakeholders have been particularly
concerned about residues in containers
that once held pharmaceuticals that are
on the ''P-list'' of acutely hazardous
commercial chemical products in
§
261.33(e) because a generator becomes
an LQG if it generates more than 1 kg
of acute hazardous waste per calendar
month.
326
The regulatory status of acute
and non-acute commercial chemical
product residues remaining in a
container are specifically addressed in
§
261.33:
''The following materials or items are
hazardous wastes if and when they are
discarded or intended to be discarded
.
.
. (c) Any residue remaining in a
container or in an inner liner removed
from a container that has held any
commercial chemical product or
manufacturing chemical intermediate
having the generic name listed in
paragraphs (e) or (f) of this section,
unless the container is empty as defined
in §
261.7(b).''
In §
261.7(b)(1), there are two ways a
container that held a non-acute
hazardous waste can be considered
''empty.'' The container is considered
empty if all wastes have been removed
that can be removed using the practices
commonly employed to remove
materials from that type of container,
e.g., pouring, pumping, aspirating, and
(1) no more than 2.5 centimeters (one
inch) of residue remain on the bottom
of the container or inner liner, or (2) No
more than 3 percent by weight of the
total capacity of the container remains
in the container or inner liner if the
container is less than or equal to 119
gallons in size; or no more than 0.3
percent by weight of the total capacity
of the container remains in the
container or inner liner if the container
is greater than 119 gallons in size.
Therefore, it is important to note that
if the container that held the non-acute
hazardous waste pharmaceutical does
not have its contents removed by a
commonly employed practice even
though it has one inch or less of residue
remaining or has 3 percent or less by
weight of the total capacity of the
container remaining,
327
the container is
still not considered ''RCRA empty.'' If
the container is not ''RCRA empty,''
then the residues are regulated as
hazardous waste (since the residues are
within the container, the container must
be managed as hazardous waste, as well,
even if it is not itself hazardous waste).
According to §
261.7(b)(3), there are
three ways that a container that held an
acute hazardous waste can be
considered empty:
(1) The container or inner liner has
been triple rinsed using a solvent
capable of removing the commercial
chemical product or manufacturing
chemical intermediate;
(2) The container or inner liner has
been cleaned by another method that
has been shown in the scientific
literature, or by tests conducted by the
generator, to achieve equivalent
removal; or
(3) In the case of a container, the inner
liner that prevented contact of the
commercial chemical product or
manufacturing chemical intermediate
with the container, has been removed.
According to these requirements, if
the container that held the P-listed
pharmaceutical is not triple rinsed, or
cleaned by another method that has
been demonstrated to achieve
equivalent removal, or had the inner
liner removed, the container is not
considered ''RCRA empty,'' even though
the pharmaceutical may have been fully
removed. If the container is not ''RCRA
empty,'' then the residues are regulated
as acute hazardous waste.
In November 2011, EPA issued
guidance about containers that once
held P-listed pharmaceuticals
328
that
provides three possible regulatory
approaches for generators:
(1) Count only the weight of the
hazardous waste residues toward
generator category
(2) Demonstrate an equivalent
removal method to render containers
RCRA empty
(3) In the case of warfarin, show that
the concentration in the residue is
below the P-listed concentration
This guidance was intended as a
short-term solution that worked within
the confines of the existing RCRA
hazardous waste regulations. In 2015,
we proposed to amend the regulations
that pertain to residues in containers
that once held pharmaceuticals that are
RCRA hazardous wastes. EPA proposed
different regulatory solutions for
different types of containers found in
healthcare settings. Specifically, the
proposal addressed the following three
categories of containers: (1) Unit-dose
containers (e.g., packets, cups,
wrappers, blister packs, and delivery
devices) and dispensing bottles and
vials; (2) dispensed syringes; and (3)
other containers, including delivery
devices. Generally, commenters were
supportive of the need for these new
empty container standards specifically
developed for the types of small
containers used in the healthcare
setting, although they did have
suggestions for changes. Each category
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329
Tolaymat, T. and A. El Badawy. Evaluation of
P-Listed Pharmaceutical Residues in Empty
Pharmaceutical Containers. U.S. Environmental
Protection Agency, Washington, DC, EPA/600/R-
14/167, 2015.
330
September 25, 2018; 80 FR 58052.
331
EPA-HQ-RCRA-2007-0932-0153 through
0156.
332
See comment number EPA-HQ-RCRA-2007-
0932-0312.
of container is discussed separately
below. Today's new ''empty container''
regulations in §
266.507 will replace the
November 2011 guidance as it pertained
to residues of hazardous waste
pharmaceuticals in containers, although
the memo will remain in effect for non-
pharmaceutical hazardous wastes.
B. Stock, Dispensing and Unit-Dose
Containers (§
266.507(a))
1. Summary of Proposal
We proposed that a dispensing bottle,
vial, or ampule (not to exceed 1 liter or
1,000 pills) or a unit-dose container
(e.g., a unit-dose packet, cup, wrapper,
blister pack or delivery device) would
be considered empty and the residues
would not be regulated as hazardous
waste if the hazardous waste
pharmaceuticals have been removed
from the dispensing or unit-dose
container by commonly employed
methods.
This proposal applied to containers
that once held acute or non-acute
hazardous waste pharmaceuticals.
Under the proposal, for containers that
once held non-acute hazardous waste
pharmaceuticals, it would not be
necessary to measure the remaining
contents. Likewise, under the proposal,
for containers that once held acute
hazardous waste pharmaceuticals, it
would not be necessary to triple rinse
the containers or demonstrate an
equivalent removal method. Rather, we
proposed that a dispensing or unit-dose
container would be considered empty if
all pharmaceuticals have been removed
using the practices commonly employed
to remove materials from that type of
container-thus, the residues (and
therefore the container as well) may be
disposed of as non-hazardous waste.
We proposed this new ''RCRA empty''
standard for containers used within a
healthcare setting for two reasons. First,
this approach will help eliminate the
sewering of pharmaceuticals. In a
healthcare setting, if containers are
triple rinsed, the rinsate will likely be
poured down the drain, which is not a
good environmental practice. We think
it is important that the residues be
managed in a more controlled manner-
such as in municipal solid waste
landfills- rather than poured down the
drain. Second, although the ''empty
container'' regulations of §
261.7 apply
to all sizes of containers, they were
developed with larger, industrial-sized
containers in mind. For the most part,
the containers that hold
pharmaceuticals are smaller in size than
a 55-gallon drum; therefore, the amount
of residue will likely be much less in
these containers. In the preamble to the
proposed rulemaking, we explained that
we selected the 1,000-pill/1-liter limit
because, in our observation, EPA had
rarely seen dispensing bottles larger
than that. We specifically sought
comment on whether larger containers
are used for dispensing pharmaceuticals
and, if so, which pharmaceuticals they
are used for and what RCRA hazardous
waste codes would apply.
In the proposal, EPA presented data
from three stakeholders helping to
confirm the assumption that very little
residue remains in containers after the
pharmaceuticals (e.g., pills) have been
removed. In addition, EPA's Office of
Research and Development conducted
similar research.
329
A summary of the
results is in the preamble to the
proposed rulemaking, while the full
results from each of the four sources are
included in the docket for the proposed
rulemaking.
330
331
EPA is aware that there are certain
limitations with the data from the four
sources. For instance, in one of the
studies, no replicate samples were
tested. In another study, only warfarin
residues were tested. However, given
the size of the containers involved and
the nominal quantities of residues
involved, the Agency proposed to allow
the residues in dispensing bottles, vials
and ampules, and single-unit dose
containers that once held hazardous
waste pharmaceuticals to be managed as
non-hazardous waste provided the
pharmaceutical product has been
removed (e.g., all pills have been
removed).
As part of the proposal, EPA raised
the concern of potential diversion of the
pharmaceutical containers that may
occur when the pharmaceutical residues
and containers are discarded in the
municipal waste stream. The Agency
proposed that RCRA-empty
pharmaceutical containers that are
original pharmaceutical packages (and
therefore susceptible to diversion)
should be destroyed prior to placing
them in the trash. These types of
containers would include dispensing
bottles, vials, or ampules typically used
in pharmacies, but would not include
paper or plastic cups, or blister packs
used for dispensing singles doses to
patients. In the preamble to the
proposal, we explained that the means
of destruction could include crushing or
shredding the container.
2. Summary of Comments
The comments for this section can be
broken into two major groups. One
group of comments expressed concern
with the 1,000-pill/1-liter size limit to
pharmaceutical dispensing containers
and commenters asked EPA to consider
allowing the new RCRA-empty standard
for pharmaceutical dispensing
containers to apply to larger
pharmaceutical containers or even to all
dispensing containers, regardless of
size.
As part of its comments, CVS Health
included results from an analysis
conducted on containers that held
warfarin.
332
Their tests included brand
name and generic warfarin stock bottles,
testing the largest stock bottles with the
highest prescription strength warfarin
typically found in a CVS Health
Pharmacy, although their comments do
not specify the size of the largest stock
bottle, nor do they specify the highest
prescription strength of warfarin. That
said, their results do offer similar results
as the studies used in support of the
proposal, indicating the range of total
residues detected was 0.0-19.8 mg
(excluding outliers).
Another group of comments objected
to the proposed requirement to destroy
the containers before disposing of them
in municipal solid waste landfills.
Commenters objected to this proposed
provision for several reasons. First, the
most common reason given by
commenters that objected to this
provision was they disagreed with EPA
that diversion of these containers is
occurring. Many states commented that
this has never been a problem in their
state and that the issues with these
types of containers arise from purchase
of empty vials on the internet and
counterfeit labels made on home
computers, not from dumpster diving.
Second, there was concern that this
would be a costly option since many
healthcare facilities would now need to
hire someone or buy equipment to
destroy the containers. Many
commenters thought the same goals
could be reached through more cost-
effective means such as defacing the
label to render the containers unusable
for illicit purposes. Third, a few
commenters were also concerned with
the release of the residues in these
containers upon destruction and the
effect that could have on the workers.
This set of commenters included the
one state that favored destruction of the
containers. Finally, some commenters
noted that these empty containers are
already being disposed of in locked
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See the email correspondence from Lisa Strutz
(APHC); Donald Dempsey (CVS Health); and Peter
Carbrey (VA) in the supporting materials of the
docket for this final rulemaking (EPA-HQ-RCRA-
2007-0932).
334
See the email correspondence from Lisa Strutz
(APHC) to Kristin Fitzgerald (EPA), dated February
9, 2017, in the supporting materials of the docket
for this final rulemaking (EPA-HQ-RCRA-2007-
0932).
335
December 1994, RCRA Online #13718.
336
Memo from Dellinger to Chilcott, April 14,
2008, RCRA Online #14788.
337
Note that since this Q&A was issued, EPA
issued guidance indicating that epinephrine salts
are not included in the scope of the P042 listing and
therefore, most, if not all, medical applications of
epinephrine are not P042 (October 15, 2007; RCRA
Online #14778).
dumpsters and there are adequate
institutional controls to address any
public health risk from use of discarded
containers in counterfeit drug sales.
3. Final Rule Provisions
In response to comments, we have
made three substantive changes to the
regulations proposed in §
266.507(a)
that define when a dispensing or unit-
dose container is empty. First, based on
comments, we now recognize that we
used the term ''dispensing'' bottle, vial,
or ampule incorrectly. Dispensing
bottles are those that are provided to
patients when they get a prescription
filled. Although a healthcare facility
such as a pharmacy may dispose of
some dispensing bottles, they are more
likely to dispose of the stock bottles that
they use to fill the dispensing bottles
provided to the patients. As a result, we
have modified the regulatory language
to include stock bottles in addition to
dispensing bottles, vials or ampules,
and unit-dose containers.
Second, after reviewing comments
and asking for additional support and
clarification from commenters,
including the Army Public Health
Center, CVS Health and the Department
of Veterans Affairs, the Agency has
increased the size of the dispensing
containers from 1,000 pills to 10,000
pills.
333
The Army Public Health Center
states that they ''routinely procure
containers containing 1K, 2K, and even
5K or 10K pill counts'' for refilling the
automated dispensing machines at their
facilities.
334
This exceeds the size of
dispensing containers that we and
others tested, but given that the contents
are solid pills, capsules and tablets, and
that the residues we and others detected
are very small, we determined that it is
appropriate to increase the size of the
stock or dispensing container to 10,000
pills.
However, we have kept the maximum
volume for stock and dispensing
containers at a maximum of 1 liter since
this volume limit would apply to
liquids (and other non-pill
formulations), which are harder to fully
remove, and commenters did not
provide sufficient information to
support increasing the volume limit.
Further, it is not clear from comments
or subsequent correspondence whether
any containers larger than 1 liter are in
use for pharmaceuticals that would be
hazardous waste when discarded. Stock
or dispensing containers that exceed 1
liter would be considered ''other
containers'' under §
266.507(d). As
such, under the final rule, if they held
pharmaceuticals that are non-acute
hazardous waste, then they would be
able to use §
261.7(b)(1) to show that
they are empty.
The third substantive change is that
we have removed the proposed
requirement to destroy the empty
pharmaceutical containers prior to
disposal. We share commenters'
concerns about possible worker
exposure during the process of crushing
or shredding the containers. However,
EPA remains concerned about the
diversion of the empty containers for
illicit purposes. Therefore, we strongly
encourage healthcare facilities to use
best management practices, such as
locked dumpsters and defacing labels,
to prevent the diversion of these
containers, but the extra step of
destroying these containers will not be
required.
Thus, under the final rule, a stock
bottle, dispensing bottle, vial, or ampule
(not to exceed 1 liter or 10,000 pills); or
a unit-dose container (e.g., a unit-dose
packet, cup, wrapper, blister pack, or
delivery device) is considered empty
and the residues are not regulated as
hazardous waste provided the
pharmaceuticals have been removed
from the stock bottle, dispensing bottle,
vial, ampule, or the unit-dose container
using the practices commonly employed
to remove materials from that type of
container.
In §
261.33(c), we have also added a
reference to the new empty container
provisions for hazardous waste
pharmaceuticals in §
266.507 as a
conforming change. Previously,
§
261.33(c) referenced only the empty
container provisions of §
261.7(b).
4. Comments and Responses
One commenter asked us to add an
explicit reference to acute/P-listed
hazardous waste in this section of the
regulations. We believe this is
unnecessary since §
261.7(c) indicates
that containers of hazardous waste
pharmaceuticals (which includes acute
and non-acute hazardous waste
pharmaceuticals) are subject to
§
266.507 in lieu of §
261.7 for
determining when they are empty.
Nevertheless, we agree with the
commenter that all of the new empty
container provisions in §
266.507 apply
to containers that held either non-acute
or acute hazardous waste
pharmaceuticals. Under the new subpart
P provisions, for containers that once
held non-acute waste pharmaceuticals
to be considered empty, it will not be
necessary to measure the remaining
contents, and for containers that once
held acute hazardous waste
pharmaceuticals, it will not be
necessary to triple-rinse the containers
or demonstrate an equivalent removal
method.
C. Syringes (§
266.507(b))
1. Summary of Proposal
EPA proposed that the residues
remaining in a syringe would not be
regulated as hazardous waste provided
the syringe had been used to administer
a pharmaceutical to a patient, the
syringe is placed in a sharps container
(if appropriate), and is managed in
accordance with all applicable federal,
state, and local medical waste or
regulated waste regulations. As with all
of the new empty container standards
proposed in §
266.507, this proposed
provision applied to syringes used to
administer pharmaceuticals that are
acute or non-acute hazardous waste
when discarded.
Prior to the proposal, EPA issued
guidance regarding the regulatory status
of residues in syringes in December
1994 and April 2008.
335
336
In the
December 1994 RCRA/Superfund
Hotline Q&A about whether
epinephrine residues in a discarded
syringe would be P042, EPA stated,
''Drug residues often remain in a
dispensing instrument after the
instrument is used to administer
medication. EPA considers such
residues remaining in a dispensing
instrument to have been used for their
intended purpose. The epinephrine
remaining in the syringe, therefore, is
not a commercial chemical product and
not a P042 hazardous waste. The
epinephrine could be a RCRA hazardous
waste, however, if it exhibits a
characteristic of hazardous waste.''
337
In the April 2008 memo, EPA clarified
that the 1994 interpretation extends to
other P- and U-listed pharmaceuticals
that have been used to administer the
pharmaceutical by syringe.
EPA thinks that it is important to
clarify in regulation when syringes are
considered RCRA empty as this has
been a source of many questions over
the years. As part of the decision
making, EPA is aware of the need to
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338
Daughton CG, Drugs and the Environment:
Stewardship & Sustainability, National Exposure
Research Laboratory, Environmental Sciences
Division, US EPA, Las Vegas, NV; NERL-LV-ES 10/
081, EPA/600/R-10/106; September 2010 (https://
cfpub.epa.gov/si/si_public_record_
report.cfm?dirEntryID=228503).
339
OSHA Title 29 CFR 1910.1030 Bloodborne
Pathogens.
340
DOT Title 49 CFR 172.343 subpart D-
Marking; 172 subpart E-Labeling Standards;
172.432 Subpart E.
341
See 21 CFR 208.3.
342
NIOSH. ''Preventing Occupational Exposures
to Antineoplastic and Other Hazardous Drugs in
Health Care Settings.'' Publication Number 2004-
165, Department of Health and Human Services,
Centers for Disease Control and Prevention (CDC),
National Institute for Occupational Safety and
Health (NIOSH), Cincinnati, OH, 2004. 58 pp;
http://www.cdc.gov/niosh/docs/2004-165/pdfs/
2004-165.pdf.
343
ASHP. ''ASHP guidelines on handling
hazardous drugs.'' American Journal of Health-
System Pharmacy 2006, 63:1172-1193; http://
dx.doi.org/10.2146/ajhp050529.
344
December 1994, RCRA Online #13718.
345
Memo from Dellinger to Chilcott, April 14,
2008, RCRA Online #14788.
minimize the potential for exposures of
healthcare workers to the sharps, which
may be contaminated with bloodborne
pathogens, as well as to the contents of
the syringes.
The preamble to the proposed
rulemaking also noted that sharps
containers containing syringes are
typically autoclaved prior to disposal.
EPA expressed concern that the residues
remaining in the syringes could be
aerosolized during autoclaving and
inadvertently expose workers to the
aerosolized hazardous waste residues,
posing risks via pulmonary exposure to
those present during venting of the
autoclave. Research suggests that
autoclaving may even increase the
toxicity of certain drugs.
338
As a result,
EPA requested comment on whether it
is necessary to place a limit on the
volume of residue or the volume of the
syringe to which this new provision
would apply or whether any other
conditions would be appropriate.
2. Summary of Comments
As noted above, commenters
generally supported EPA's goal of
codifying new standards for defining
when containers are considered empty,
including syringes. EPA received many
comments requesting that the Agency
clarify what it means when it uses the
term ''dispensed.'' Further, they noted
that although the proposed regulations
used the term ''dispensed,'' in several
cases in the preamble, we used the term
''fully dispensed'' and they requested
clarification about which was correct.
Commenters also noted that EPA used
the term ''dispensed'' inappropriately
and stated that the term ''administered''
was more appropriate. The Agency
received mixed comments on whether
any residues or contents should be left
in the syringes when disposing of the
syringe. In the case of autoclaving
residues in syringes, almost all
commenters agreed that the hazardous
waste pharmaceutical residues should
not be autoclaved. Some commenters
believed that the contents should be
disposed of in a gauze pad or equivalent
while others argued that this was in
contradiction to NIOSH
recommendations for minimizing
exposure to hazardous drugs. Some
commenters were comfortable with
leaving contents in the syringes,
suggesting that would be in compliance
with OSHA
339
and DOT.
340
3. Final Rule Provisions
We have made two substantive
changes to this section of the regulations
that define when syringes are
considered empty for the sake of RCRA
regulation. First, EPA agrees with
commenters that we used the term
''dispensed'' inappropriately in the
proposed rulemaking. FDA defines
''dispense to patients to mean the act of
delivering a prescription drug product
to a patient or an agent of the
patient.''
341
Dispensed pharmaceuticals
are then administered directly to the
patient. EPA has revised the regulations
to address commenters' concerns. In the
final rule, to avoid confusion, when
discussing syringes we do not use the
term dispensed, fully dispensed, or
administered. Instead, under the final
rule, a syringe is considered empty and
the residues are not regulated as
hazardous waste provided the contents
have been removed by fully depressing
the plunger of the syringe. Thus, the
final regulations convey an intent that is
more similar to the proposed preamble
use of the term ''fully dispensed.'' This
reflects commenters' and EPA's desire
to avoid the possibility of autoclaving
syringes that may have a large portion
of their hazardous waste pharmaceutical
contents remaining.
Commenters affirmed EPA's concerns
about aerosolizing the autoclaved
hazardous waste in sharps containers
and we have concluded that hazardous
waste incineration of hazardous waste
pharmaceuticals remaining in non-
empty syringes is more appropriate. A
recent literature search also supports
this position. The NIOSH and the
American Society of Hospital
Pharmacists (ASHP) have both
published articles regarding autoclaving
of sharps. The 2004 NIOSH alert states,
''Do not place hazardous drug-
contaminated sharps in red sharps
containers that are used for infectious
wastes, since these are often autoclaved
or microwaved.''
342
The ASHP article
states, ''Sharps used in the preparation
of hazardous drugs should not be placed
in red sharps containers or needle
boxes, since these are most frequently
disinfected by autoclaving or
microwaving, not by incineration, and
pose a risk of aerosolization to waste-
handling employees.''
343
A syringe with a fully depressed
plunger will have a minute amount of
residue and the syringe can be
considered empty under the final rule.
Thus the residue in the empty syringe
(as well as the syringe) will not be
regulated as hazardous waste. A syringe
that does not have a fully depressed
plunger could have anything from a
small amount to 99% of hazardous
waste pharmaceutical contents still left
in it. Therefore, we have concluded that
it is impracticable to impose an
alternate bright line for determining
whether a partially administered syringe
is empty. Further, we concur with
ASHP and NIOSH regarding concerns
about the safety of autoclave operators
and believe the standard in this final
rule will help prevent exposing workers
to volatilized hazardous waste
pharmaceutical residues during the
autoclaving process.
The second substantive change we
made in the final rule is to clarify that
if a syringe contains a pharmaceutical
that is a hazardous waste and it is not
empty because the plunger is not fully
depressed, the syringe must be placed
with its remaining hazardous waste
pharmaceuticals into a container that is
managed and disposed of as a non-
creditable hazardous waste
pharmaceutical under this subpart as
well as any applicable federal, state, and
local requirements for sharps containers
and medical or regulated waste. We note
that the new empty syringe provisions
being finalized today supersedes the
previous EPA interpretations expressed
in guidance memos in December 1994
and April 2008.
344
345
We note that a syringe can become
empty in three ways: (1) Fully
depressing the plunger of the syringe by
administering the contents of the
syringes to a patient, or (2) fully
depressing the plunger by injecting the
contents of the syringe into another
delivery device such as an IV bag, or (3)
fully depressing the plunger of the
syringe by emptying the remaining
contents into a hazardous waste
collection container.
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346
See 29 CFR 1910.1030(d)(1).
347
See 29 CFR 1910.1030(d)(4)(iii)(A)(1).
348
See 29 CFR 1910.1030(d)(4)(iii)(A)(2)(i).
349
OSHA Compliance Directive CPL 02-02-069
Enforcement Procedures for the Occupational
Exposure to Bloodborne Pathogens https://
www.osha.gov/OshDoc/Directive_pdf/CPL_02-02-
069.pdf.
350
Ibid.
351
See 29 CFR 1910.1030(d)(4)(iii)(C).
4. Consultation With OSHA
As part of the final rule process, EPA
consulted with OSHA to gain a better
understanding of its Bloodborne
Pathogens standard and how it interacts
with other regulations for the disposal
of sharps and the contents within the
syringes. The Bloodborne Pathogens
standard states that ''[u]niversal
precautions shall be observed to prevent
contact with blood or other potentially
infectious materials. Under
circumstances in which differentiation
between body fluid types is difficult or
impossible, all body fluids shall be
considered potentially infectious
materials.''
346
It also states that disposal
of a sharp shall be done ''immediately
or as soon as feasible.''
347
Further,
OSHA requires that containers for
contaminated sharps shall be ''easily
accessible to personnel and located as
close as is feasible to the immediate area
where sharps are used or can reasonably
anticipated to be found.''
348
When
workers travel to a remote location to
discard a sharp, it increases the
possibility of an accidental needlestick,
increases the chances that needles and
other sharps will be improperly
discarded, and creates potential hazards
for other staff members. The
determination of whether or not a
sharps disposal container is as close as
feasible should be made on a case-by-
case basis by OSHA.
349
Therefore, the practice of emptying
the contents of the syringe would not
violate the OSHA standard if the
containers are as close as feasible. Any
related work practices must also be such
that they do not create additional
hazards to workers (e.g., containers are
located in close proximity to the work
area to avoid employees travelling with
used sharps to disposal receptacles
located outside the point of use).
Furthermore, nothing in this new
subpart requires workers to recap
needles or other sharps, or otherwise
manually manipulate the sharp or
needle during emptying, such as
unscrewing the needle from the syringe.
As part of this consultation, OSHA
addressed the issue of waste disposal.
OSHA's Bloodborne Pathogens
compliance directive states: ''[W]hile
OSHA specifies certain features of the
regulated waste containers, including
appropriate tagging, the ultimate
disposal method (landfilling,
incinerating, and so forth) for medical
waste falls under the purview of the
EPA and possibly State and local
regulations'' (''Disposal of all regulated
waste shall be in accordance with
applicable regulations of the United
States, States and Territories, and
political subdivisions of States and
Territories'' (1910.1030(d)(4)(iii)(C))).
350
The Agency also received comment
that we should recommend the extra
protective step that all syringes/sharps
be incinerated. Any sharps container
that contains hazardous waste must be
treated to meet the LDR requirements in
part 268. In most cases, the LDR
treatment standard for hazardous waste
pharmaceuticals is incineration. On the
other hand, if a sharps container does
not contain hazardous waste
pharmaceuticals because all the syringes
have been emptied by fully depressing
the plunger, then the RCRA hazardous
waste regulations would not apply to
these sharps containers (although these
sharps containers are still solid wastes).
Regardless of whether sharps
containers have regulated hazardous
waste pharmaceutical residues, they
could contain bloodborne pathogens or
other infectious materials. Thus,
OSHA's Bloodborne Pathogens standard
requires that ''disposal of all regulated
waste shall be in accordance with
applicable regulations of the United
States, States and Territories, and
political subdivisions of States and
Territories.''
351
Many states have
medical waste regulations that require
the treatment of regulated medical
waste, including sharps containers, to
render it non-infectious, which is often
achieved by autoclaving, prior to
disposal as solid waste.
D. Other Containers, Including Delivery
Devices (§
266.507(c) & (d))
1. Summary of Proposal
EPA proposed that the residues
remaining in other types of unused or
used containers, including delivery
devices, such as IV bags and tubing,
inhalers, aerosols, nebulizers, tubes of
ointments, gels, or creams, would be
regulated as hazardous waste if the
residues are acute or non-acute
hazardous waste. In some cases, such as
with IV bags, the volume of hazardous
waste being disposed is much larger
than with residues contained in syringes
or unit-dose containers. It is extremely
difficult to determine how much residue
remains in tubes of ointments, gel, or
cream. In the case of aerosols, it would
be inadvisable to remove the contents of
the container. Since EPA proposed that
hazardous waste pharmaceuticals
managed under subpart P would not be
counted towards a facility's generator
category, we argued that managing these
residues and containers as hazardous
waste under the proposed provisions
should not pose the same burden that
generators had been facing in with
keeping track of the monthly amount of
residues in containers that are not
''RCRA empty.''
2. Summary of Comments
Comments were mixed in this section.
Some commenters agreed with EPA that
it is difficult to determine if containers
such as inhalers, aerosol cans, tubes of
ointments, gels, or creams meet the
RCRA empty standards within §
261.7
and, therefore, managing them under
the streamlined requirements of subpart
P would be protective. Other
commenters wanted EPA to allow these
other containers to continue to meet the
definition of empty within §
261.7 or
develop specific empty container
standards for them within subpart P.
One commenter recommended that EPA
revise the regulations to state that IV
bags and their tubing, inhalers, aerosols,
nebulizers, tubes of ointments, and gels
or creams are RCRA empty and not
subject to hazardous waste regulations if
they contain non-acute hazardous waste
and their contents are fully
administered.
3. Final Rule Provision
In response to comments, the final
rule contains an empty container
standard for IV bags separate from other
containers, including delivery devices.
The Agency stated in the proposal that
it is very hard to determine if aerosols,
tubes of ointments, gels and creams,
inhalers, and nebulizers are empty due
to their containers and contents. As
commenters pointed out, this is not the
case for IV bags and tubing since they
are transparent and the liquids inside
can be easily observed.
Taking approaches suggested from
commenters, EPA is finalizing in
§
266.507(c) that an IV bag is considered
empty and the residues are not
regulated as hazardous waste provided
the pharmaceuticals in the IV bag have
been fully administered to a patient. In
cases where the IV bag has not been
fully administered and the IV bag held
non-acute hazardous waste
pharmaceuticals, then IV bag can be
shown to be empty and the remaining
residues not regulated as hazardous
waste per §
261.7(b)(1). If an IV bag is
not empty through either of these means
because it either has not been fully
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administered or cannot meet the
requirements of §
261.7(b)(1) or because
it contained an acute hazardous waste
pharmaceutical, the IV bag must be
placed with its remaining hazardous
waste pharmaceuticals into a container
that managed and disposed of as a non-
creditable hazardous waste
pharmaceutical under this subpart.
In the final rule, EPA has also altered
the requirements for other types of
containers including delivery devices.
Commenters pointed out that a
healthcare facility should not be
precluded from proving that these
containers meet the RCRA-empty
standards in §
261.7 simply due to the
type of container or contents. EPA
agrees with the commenters that these
types of containers which held non-
acute hazardous waste pharmaceuticals
should be able to use the RCRA empty
container standards under §
261.7 and
has changed the final rule to allow this.
If the containers meet the RCRA empty
standard under §
261.7 then the non-
acute hazardous waste pharmaceutical
residues (and the container) are not
regulated as hazardous waste and can be
managed as solid waste.
If these other containers, a category
that includes but is not limited to
inhalers, aerosols, nebulizers, tubes of
ointments, gels or creams, once held an
acute hazardous waste pharmaceutical
or if they held a non-acute hazardous
waste pharmaceutical but cannot meet
the RCRA empty container standard of
§
261.7, then the residues of these
hazardous waste pharmaceuticals (and
their containers) must be managed as
non-creditable hazardous waste
pharmaceuticals under this subpart.
4. Comments and Responses
One commenter was concerned that
managing all other containers that held
hazardous waste pharmaceuticals as
non-empty could cause a VSQG
healthcare facility to bump up in
generator category to an LQG. This will
no longer be a concern since a
healthcare facility now has the option to
prove that their other containers that
held non-acute hazardous waste
pharmaceuticals meet the RCRA empty
container standards in §
261.7 and they
can manage the residues (and
containers) as non-hazardous waste.
Otherwise, if these other containers are
not considered empty, then the residues
(and containers) must be managed as
non-creditable hazardous waste
pharmaceuticals under subpart P and
hazardous waste pharmaceuticals
managed under subpart P do not count
towards determining the generator
category. Further, we note that a
healthcare facility can use the new
empty container provisions in §
266.507
when determining whether they
generate enough hazardous waste to
become subject to part 266 subpart P.
XVI. Shipping Standards for Hazardous
Waste Pharmaceuticals (§§
266.508 and
266.509)
A. Shipping Non-Creditable Hazardous
Waste Pharmaceuticals From
Healthcare Facilities to Treatment,
Storage, and Disposal Facilities
(§
266.508(a))
1. Summary of Proposal
Under part 266 subpart P, hazardous
waste pharmaceuticals generated in a
healthcare facility fall into two
categories: (1) Non-creditable hazardous
waste pharmaceuticals (e.g., partially
administered for patient care), and (2)
potentially creditable hazardous waste
pharmaceuticals (e.g., unused,
unadministered). This section discusses
the proposed requirements for shipping
non-creditable hazardous waste
pharmaceuticals. For information
regarding the shipment of potentially
creditable hazardous waste
pharmaceuticals from healthcare
facilities and reverse distributors, see
section XVI.D. of this preamble.
Generally, non-creditable hazardous
waste pharmaceuticals differ from
potentially creditable hazardous waste
pharmaceuticals in that they have been
partially administered and often are not
in their original packaging. In addition,
since there is not a reasonable
expectation that prescription non-
creditable hazardous waste
pharmaceuticals are eligible to receive
manufacturer credit, they are shipped
off site to a TSDF rather than a reverse
distributor. Due to concerns that a
healthcare facility might send all of its
hazardous waste pharmaceuticals to a
reverse distributor even if there is not a
reasonable expectation of receiving
manufacturer credit-essentially using
the reverse distributor as a TSDF-EPA
proposed that non-creditable hazardous
waste pharmaceuticals generated at
healthcare facilities, when shipped off
site, must be shipped to a designated
facility (e.g., an interim status or
permitted hazardous waste TSDF), as
was required under part 262 (unless the
healthcare facility has interim status or
a RCRA permit to store or treat
hazardous waste and chooses to store or
treat the non-creditable hazardous waste
pharmaceuticals on site instead of
shipping them to a designated facility).
Specifically, EPA proposed that
healthcare facilities shipping non-
creditable hazardous waste
pharmaceuticals to a designated facility
for treatment or disposal must continue
to comply with the existing Department
of Transportation (DOT) pre-transport
requirements for packaging, labeling
and marking, and that the non-
creditable hazardous waste
pharmaceuticals must continue to be
shipped using a hazardous waste
transporter and be tracked with a
hazardous waste manifest. However, to
avoid unnecessarily burdening the
healthcare facility staff, who the Agency
assumes are typically unfamiliar with
RCRA, EPA proposed that the hazardous
waste numbers (often called hazardous
waste codes) are not required to be
entered into the hazardous waste
manifest for non-creditable hazardous
waste pharmaceuticals. In lieu of
hazardous waste codes, EPA proposed
that the words, ''hazardous waste
pharmaceuticals'' must be entered in the
''special handling and additional
information'' box on the manifest (this
box was called Item 14 at the time of the
proposal).
We also proposed that all existing
RCRA recordkeeping requirements
regarding hazardous waste manifesting
as well as all applicable DOT shipping
requirements continue to apply to
healthcare facilities shipping non-
creditable hazardous waste
pharmaceuticals to a TSDF for treatment
or disposal (see section X.K).
2. Summary of Comments
Comments on this section of the
proposed rulemaking were mixed.
Commenters generally agreed with the
proposed standards for packaging,
labeling, marking, placarding, and
shipping papers. Adverse comments
were mostly in regard to the decision to
not require individual waste codes on
the manifest for a healthcare facility
sending non-creditable hazardous waste
pharmaceuticals to a TSDF for disposal.
In fact, commenters were generally
concerned about the proposal to not
require individual waste codes
anywhere in the management standards
for healthcare facilities managing non-
creditable hazardous waste
pharmaceuticals. Whether the
comments were regarding waste code
determinations, labeling containers with
waste codes, or including waste codes
on the manifest, the overarching
concern was that TSDFs would not
know the specific contents of shipments
received, resulting in an increase to
their burden, and possibly would be
detrimental to human health and the
environment. Therefore, the adverse
comments regarding the lack of a
proposed requirement to input
individual waste codes on the manifest
are applicable more broadly to the
subject of whether or not the
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information that individual waste codes
convey should somehow be provided to
a TSDF by the healthcare facility
shipping non-creditable hazardous
waste pharmaceuticals.
Some states agreed with the proposal
to not require individual waste codes on
the manifest, while others commented
that it is important to have waste codes
at all steps where they would otherwise
be required under previous RCRA
regulations. Comments from waste
management companies were also
mixed, with some supporting the
proposal to not require individual
hazardous waste codes on the manifest,
while others agreed with the proposal
but suggested including a profile of
likely constituents to alert TSDFs of
potential waste contents to aid in LDR
compliance.
Those waste management companies
that disagreed with the proposed
standards cited the added burden
imposed by not knowing the specific
waste constituents included in a
shipment, which would make
compliance with LDR standards more
difficult. They were primarily
concerned about the added burden of
having to either begin testing their ash
for wastes that have a numeric treatment
standard, or modify existing testing
protocols. One commenter from the
healthcare industry disagreed with the
elimination of individual hazardous
waste codes on manifests from
healthcare facilities shipping non-
creditable hazardous waste
pharmaceuticals, arguing that healthcare
workers are capable of making accurate
hazardous waste determinations. They
also stated that hazardous waste codes
are integral to properly managing
hazardous waste. One waste
management commenter stated that
continuing to require waste codes on
LDR notices altogether negates any
actual relief because healthcare facilities
will have to determine appropriate
waste codes before sending hazardous
waste pharmaceuticals off site to a TSDF
whether or not they are required on the
container label or manifest.
One reverse distributor also agreed
with the proposed standards under the
condition that the Agency agree that
pharmaceuticals being sent to a reverse
distributor are not waste.
3. Final Rule Provisions
The agency is finalizing the majority
of the proposed requirements in this
section. Before being shipped off site, all
shipments of non-creditable hazardous
waste pharmaceuticals must comply
with applicable DOT pre-transport
requirements for packaging (49 CFR
parts 173, 178, and 180), labeling (49
CFR part 172 subpart E), and marking
(49 CFR part 172 subpart D). There are,
however, three notable changes being
finalized.
First, §
266.508(a)(1)(v) has been
removed and a healthcare facility
shipping hazardous waste
pharmaceuticals to a TSDF for disposal
must instead comply with
§
266.508(a)(2)'s manifest requirement
to meet DOT's shipping papers
requirement.
Second, the agency has decided to
modify the proposal to not require any
hazardous waste codes in Item 13
(Waste Codes) of the hazardous waste
manifest for shipments of non-creditable
hazardous waste pharmaceuticals being
sent to a TSDF, and write the words
''Hazardous Waste Pharmaceuticals'' in
Item 14 (Special Handling Instructions
and Additional Information). The
Agency is instead finalizing a
requirement to write only one waste
code- ''PHARMS''-in Item 13, and not
impose any requirements for what must
be written in Item 14. After further
consideration of the impacts this
proposed requirement would impose on
implementation and data collection, the
Agency decided it had to be modified.
During the development of this rule, the
Agency has also been developing the
electronic manifest system (e-Manifest)
which requires that some code be
written in Item 13. We chose the
PHARMS code because it both meets the
required number of characters and
communicates the nature of the waste.
Since the waste will now be sufficiently
characterized in Item 13, the Agency
feels there is no longer the need to
require the words ''hazardous waste
pharmaceuticals'' in Item 14.
This new PHARMS code is for
manifesting and reporting purposes only
and is not an official EPA hazardous
waste code. Because it will be written in
the same place as other official EPA
hazardous waste codes, it may also be
referred to colloquially as a ''hazardous
waste code.'' However, it does not
modify any existing LDR treatment
standards, nor does it enact any new or
alternate LDR treatment standards for
hazardous waste pharmaceuticals. Many
commenters throughout the proposed
rulemaking suggested that EPA
promulgate an alternative treatment
standard of the ''CMBST'' code
specifically for hazardous waste
pharmaceuticals with numeric
treatment standards. The agency
considered incorporating these
suggestions into the proposed
rulemaking, but did not receive the
necessary data to support such an
action. The Agency does, however,
generally agree that implementing a new
alternative treatment standard for
hazardous waste pharmaceuticals might
help mitigate burden on the regulated
community while remaining protective
of human health and the environment.
The Agency remains open to
considering the addition of an
alternative treatment standard for
hazardous waste pharmaceuticals in
future rulemakings.
Although the Agency is now requiring
the PHARMS code in Item 13 for
shipments of non-creditable hazardous
waste pharmaceuticals from a
healthcare facility to a TSDF, hazardous
waste codes are not required on the
manifest, which was preferred by some
commenters. As a result, TSDFs treating
hazardous waste pharmaceuticals will
have to assume that shipments of
hazardous waste pharmaceuticals
contain the few that have numeric
treatment standards in order to
demonstrate compliance with LDRs.
The third change made to the
regulations was to modify the regulatory
language in §
266.508(a) slightly to
clarify that shipments of non-creditable
hazardous waste pharmaceuticals being
sent from a healthcare facility for
disposal must be sent to a designated
facility and accompanied by a
hazardous waste manifest. As part of the
manifest requirements in 40 CFR part
262 subpart B, shipments of non-
creditable and evaluated hazardous
waste pharmaceuticals must be sent to
a designated facility via a hazardous
waste transporter. One commenter
noted that the proposed language could
have been interpreted to mean that such
shipments are also allowed to go
elsewhere, which was not the Agency's
intent.
Another substantive change to the
regulatory language that resulted from
incorporating commenters' concerns
was to remove the requirements for
shipping papers in §
266.508(a)(1)(v). A
commenter pointed out that the
requirement is unnecessary given the
requirements in §
266.508(a)(2) and the
Agency agreed. Section 266.508(a)(1)(v)
would have required a healthcare
facility shipping non-creditable
hazardous waste pharmaceuticals to a
TSDF to prepare shipping papers in
accordance with 49 CFR 172 subpart C;
however, the subsequent paragraph
(§
266.508(a)(2)) outlines the
requirements for manifesting a shipment
of non-creditable hazardous waste
pharmaceuticals. Requiring both
shipping papers and a manifest is
redundant and could have possibly
resulted in confusion and contradictory
requirements. The hazardous waste
manifest requirements, if complied
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with, duly satisfy DOT's shipping paper
requirements.
The wording in §
266.508(a) was
modified slightly to clarify that
healthcare facilities and reverse
distributors that ship non-creditable and
evaluated hazardous waste
pharmaceuticals off site, respectively,
are required to send them to a
designated facility.
Finally, to be consistent with the
Hazardous Waste Generator
Improvements final rule, we have added
paragraph 266.508(a)(1)(iii)(C) to mirror
§
262.32(d), which addresses marking
for lab packs. Specifically, lab packs of
hazardous waste pharmaceuticals that
will be treated using the alternative
treatment standard of incineration, as
allowed by §
268.42(c), do not have to
marked or labeled with EPA hazardous
waste numbers. However, lab packs that
contain D004 (arsenic), D005 (barium),
D006 (cadmium), D007 (chromium),
D008 (lead), D010 (selenium) or D011
(silver), the EPA hazardous waste
number must be marked or labeled with
the EPA hazardous waste numbers (or
electronic means may be used). These
specific metals must be identified
because §
268.42(c)(4) requires any
incinerator residues from lab packs that
contain any of these specific metals to
undergo further treatment prior to land
disposal.
B. Shipping Evaluated Hazardous Waste
Pharmaceuticals From Reverse
Distributors to Treatment, Storage, and
Disposal Facilities (§
266.508(a))
1. Summary of Proposal
For reverse distributors, once a
potentially creditable hazardous waste
pharmaceutical has been evaluated and
it has been determined that it is not
destined for another reverse distributor
for further evaluation or verification of
credit, EPA proposed that the hazardous
waste pharmaceuticals be referred to as
''evaluated hazardous waste
pharmaceuticals.'' As with shipping
non-creditable hazardous waste
pharmaceuticals, when evaluated
hazardous waste pharmaceuticals are
shipped off-site, EPA proposed that they
must be shipped in accordance with the
existing DOT pre-transport requirements
under 49 CFR parts 172-80 for
packaging, labeling, marking,
placarding, and shipping papers. We
also proposed that they must be shipped
in accordance with the existing RCRA
manifest requirements of 40 CFR part
262 subpart B, which requires all
relevant waste codes be listed in Item 13
and that they be shipped via a
hazardous waste transporter to a
designated facility. This continues
current practices under existing
regulations for this type of hazardous
waste pharmaceutical and does not
represent an increase in burden. EPA
argued that the use of a hazardous waste
manifest and a hazardous waste
transporter are appropriate at this point
for two reasons. First, once credit for the
hazardous waste pharmaceuticals has
been verified, the potential for
mismanagement is greater because
evaluated pharmaceuticals no longer
retain any value and will cost the
reverse distributor money to dispose.
Second, TSDFs are accustomed to
receiving hazardous waste via a
hazardous waste transporter with a
hazardous waste manifest and it would
place administrative and compliance
burdens on the receiving TSDF to accept
shipments of hazardous waste with
alternative tracking.
EPA proposed that a reverse
distributor must list all appropriate
hazardous waste codes on the manifest
when shipping evaluated hazardous
waste pharmaceuticals to a TSDF. This
differs from the requirements for a
healthcare facility shipping non-
creditable hazardous waste
pharmaceuticals to a TSDF. Unlike non-
creditable hazardous waste
pharmaceuticals generated at a
healthcare facility, hazardous waste
pharmaceuticals received by reverse
distributors are typically in the
manufacturer's original, intact, and
labeled packaging (if not, they are likely
non-creditable hazardous waste
pharmaceuticals and should be sent to
a TSDF), so the information needed to
determine the appropriate hazardous
waste codes once evaluated should be
readily available to the reverse
distributor. Also, reverse distributors are
currently required to include hazardous
waste codes on the manifest and it is
expected that they have the necessary
expertise in the management of these
hazardous wastes that healthcare
personnel lack. Under the reverse
distributor standards in
§
266.510(c)(10)(ii), EPA also proposed
that reverse distributors must keep
copies of hazardous waste manifests for
three years from the date evaluated
hazardous waste pharmaceuticals are
shipped to a TSDF.
2. Summary of Comments
Comments in this section were mixed.
Many commenters addressed the
standards for healthcare facilities
sending shipments of non-creditable
hazardous waste pharmaceuticals to a
TSDF but did not specifically mention
the standards for shipping evaluated
hazardous waste pharmaceuticals to a
TSDF. Nevertheless, many of the
concerns expressed by commenters with
the standards for healthcare facilities
shipping non-creditable hazardous
waste pharmaceuticals to a TSDF are
relevant because the standards in
§
266.508 are the same for healthcare
facilities shipping non-creditable
hazardous waste pharmaceuticals as
they are for reverse distributors
shipping evaluated hazardous waste
pharmaceuticals, with the exception of
§
266.508(a)(2)(i) and (ii). The few that
commented directly on the proposed
shipping standards for evaluated
hazardous waste pharmaceuticals being
shipped from a reverse distributor to a
TSDF agreed with the standards as
proposed.
Reverse distributor and waste
management industry commenters were
in agreement with the proposed
standards for shipping evaluated
hazardous waste pharmaceuticals to a
TSDF, but to reiterate, did not agree
with the standards for shipping non-
creditable hazardous waste
pharmaceuticals from a healthcare
facility to a TSDF (no waste codes on
the manifest). Many commenters on this
section simply stated that waste codes
should be included on a manifest,
referring to the requirements in
§
266.508(a)(2)(i) and (ii) which do not
require waste codes on the manifest for
healthcare facilities shipping non-
creditable hazardous waste
pharmaceuticals to a TSDF. Since those
standards only apply to healthcare
facilities shipping non-creditable
hazardous waste pharmaceuticals to a
TSDF and not reverse distributors
sending evaluated hazardous waste
pharmaceuticals to a TSDF, the agency
assumes that those same commenters
are generally in agreement with the
requirement for reverse distributors
shipping evaluated hazardous waste
pharmaceuticals to a TSDF to comply
with all of the manifest standards in 40
CFR part 262 subpart B, which includes
a requirement to list all applicable EPA
hazardous waste codes on the manifest.
3. Final Rule Provisions
The Agency is finalizing the standards
for shipping evaluated hazardous waste
pharmaceuticals from a reverse
distributor to a TSDF with minor
changes. First, §
266.508(a)(1)(v) has
been removed. The standards for
shipping papers for reverse distributors
sending evaluated hazardous waste
pharmaceuticals to a TSDF are
contained instead in subparagraph
§
266.508(a)(2) (i.e., the manifest).
Second, the clarification to the
regulatory language mentioned
previously, which specifies that non-
creditable hazardous waste
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In the proposed rule we referenced part 262
subparts E and F when discussing this provision.
Part 262 subparts E and F have since been replaced
by part 262 subpart H; see the Hazardous Waste
Export-Import Revisions final rule, 81 FR 85696;
December 31, 2016.
353
See the final Hazardous Waste Export-Import
Revisions rule, 81 FR 85696; December 31, 2016.
354
See the survey of reverse distributors in docket
number: EPA-HQ-RCRA-2007-0932-0158 through
0160.
pharmaceuticals must go only to a
TSDF, also applies to evaluated
hazardous waste pharmaceuticals. As
mentioned above, commenters were
concerned that the proposed regulatory
language appeared to make it optional
for a reverse distributor to ship
evaluated hazardous waste
pharmaceuticals to a TSDF for disposal,
although it was not intended to read
that way. The finalized regulatory
language was modified to clarify that a
reverse distributor shipping evaluated
hazardous waste pharmaceuticals must
send them to a TSDF for treatment and
disposal. This change pertains to both
evaluated pharmaceuticals being
shipped from a reverse distributor as
well as non-creditable hazardous waste
pharmaceuticals being shipped from a
healthcare facility.
To summarize, reverse distributors
sending evaluated hazardous waste
pharmaceuticals to a TSDF for disposal
are required to comply with all
standards in §
266.508(a), which
includes a requirement to list all
applicable waste codes in Item 13 of the
manifest, even though healthcare
facilities sending non-creditable
hazardous waste pharmaceuticals to a
TSDF do not. They are not, however,
required to write the word PHARMS in
Item 13 or on the container label in
addition to all other applicable waste
codes.
C. Shipping Non-Creditable or
Evaluated Hazardous Waste
Pharmaceuticals for Import or Export
(§§
266.508(b) and 266.508(c))
1. Summary of Proposal
Under part 262, a healthcare facility
or reverse distributor may not import
hazardous waste pharmaceuticals unless
it has a RCRA permit or interim status
that allows it to accept hazardous waste
from off site and complies with the
requirements for importing hazardous
waste in 40 CFR part 262 subpart H.
Under part 266, EPA did not propose to
change the regulations as they apply to
the import of non-creditable or
evaluated hazardous waste
pharmaceuticals. Likewise, under part
262, a healthcare facility or reverse
distributor may not export (non-
creditable nor evaluated) hazardous
waste pharmaceuticals unless it
complies with requirements for
exporting hazardous waste in 40 CFR
part 262 subpart H. Under part 266, EPA
did not propose to change the
regulations as they apply to the export
of (non-creditable or evaluated)
hazardous waste pharmaceuticals.
352
EPA requested comment on the
likelihood that non-creditable
hazardous waste pharmaceuticals that
are shipped from a healthcare facility to
a domestic TSDF, would then be
exported to a TSDF in a foreign country.
In addition, EPA did not anticipate that
hazardous waste pharmaceuticals would
be destined for transboundary
shipments for purposes of recovery
operations and therefore potentially
subject to 40 CFR part 262 subpart H;
however, we also requested comment on
whether this is the case.
2. Summary of Comments
We received no comments on the
proposed standards for importing and
exporting non-creditable or evaluated
hazardous waste pharmaceuticals.
3. Final Rule Provisions
Since part 266 subpart P was
proposed, the hazardous waste import
and export regulations under part 262
have been revised.
353
The export
regulations which had been in part 262
subpart E are now in part 262 subpart
H. Likewise, the import regulations
which had been in part 262 subpart F
are also now in part 262 subpart H. The
requirements for both importing and
exporting non-creditable hazardous
waste pharmaceuticals are being
substantially finalized as proposed. The
only change being made from the
proposed requirements is to update the
reference to the revised part 262
regulations, in order to conform to the
changes implemented in the Hazardous
Waste Imports and Exports
Improvement Rule. Whereas the
proposed §
266.508(b) and (c) refer to
the standards in 40 CFR part 262
subpart E and F, they now refer to 40
CFR part 262 subpart H.
D. Shipping Potentially Creditable
Hazardous Waste Pharmaceuticals
(§
266.509).
1. Summary of Proposal
This section discusses the proposed
requirements for shipping potentially
creditable hazardous waste
pharmaceuticals from a healthcare
facility to a reverse distributor and
between reverse distributors. The return
of potentially creditable waste
pharmaceuticals (hazardous and non-
hazardous) to a reverse distributor can
involve multiple shipping steps before
the pharmaceuticals are transported for
ultimate treatment and disposal. In
comments on the 2008 Pharmaceutical
Universal Waste proposal and in
response to EPA's request for
information,
354
reverse distributors
described various scenarios. For
example, a healthcare facility typically
sends waste pharmaceuticals to the
reverse distributor with which it has a
contract. However, some manufacturers
will only provide manufacturer credit
after the pharmaceuticals have been
returned to the reverse distributor with
which the manufacturer has a contract.
Thus, if the reverse distributor with
which the healthcare facility has a
contract differs from the reverse
distributor with which the manufacturer
has a contract, then the healthcare
facility's reverse distributor must send
the pharmaceuticals on to the
manufacturer's reverse distributor for
the manufacturer credit to be given to
the healthcare facility. In some cases, a
pharmaceutical manufacturer may
require the reverse distributor to ship
the pharmaceuticals back to them so
they can perform the verification and
issue credit themselves. The estimated
amount of pharmaceuticals transported
from reverse distributors to
manufacturers for verification varies.
Based on our request for information,
reverse distributors indicated that the
percent of potentially creditable
hazardous waste pharmaceuticals
transported to manufacturers ranged
from an estimated 25 percent to 93
percent of total volume, depending on
the contractual agreement between the
reverse distributor and the
manufacturer. The scenarios described
previously occur routinely and are an
integral part of the process by which
manufacturers issue credit.
As explained in section IV.A, EPA
proposed that all pharmaceuticals
transported to reverse distributors for
manufacturer credit are solid wastes,
some of which would also be
considered hazardous wastes. The
finalized regulations have been
modified, however, such that only
prescription pharmaceuticals going
through reverse distribution for
manufacturer credit are solid wastes,
while OTC pharmaceuticals going
through reverse logistics are outside of
this rule. Under the part 262
regulations, hazardous waste, including
hazardous waste pharmaceuticals, must
be manifested to a permitted or interim
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Part 262 subparts E and F have since been
replaced by part 262 subpart H; see the Hazardous
Waste Export-Import Revisions final rule, 81 FR
85696; December 31, 2016.
status TSDF and shipped using a
hazardous waste transporter to ensure
the cradle-to-grave system of RCRA is
maintained. However, compared to
other hazardous wastes, EPA believes
that the risk of environmental release
posed by most potentially creditable
hazardous waste pharmaceuticals
during accumulation and transport is
relatively low. The risk is low because
of the form and packaging of most
potentially creditable hazardous waste
pharmaceuticals, which is typically in
small, individually packaged doses
(such as with many tablets and
capsules) or small vials. These small
volumes of individually wrapped or
packaged pharmaceuticals, when
aggregated in a larger container, are
unlikely to spill or be released into the
environment since they are essentially
double-packed when transported to a
reverse distributor. Potentially
creditable hazardous waste
pharmaceuticals that are in liquid and
aerosol forms may pose more of a risk
during accumulation and transport due
to possible spillage or leakage, but the
small quantities in which they are
generated, along with the DOT
packaging requirements of 49 CFR parts
173, 178, and 180, would likely mitigate
this risk (see EPA's recommendation
regarding liquids and aerosols in section
XI.C.1). Further, the 2008
Pharmaceutical Universal Waste
proposal specifically sought comment
regarding the risks of transportation of
hazardous waste pharmaceuticals and
no commenters identified
environmental risks.
Due to the low risk to human health
and release to the environment, EPA
proposed to allow potentially creditable
hazardous waste pharmaceuticals to be
shipped without a hazardous waste
manifest and without the use of
hazardous waste transporters when the
healthcare facility is sending potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor
or when a reverse distributor is sending
potentially creditable hazardous waste
pharmaceuticals to another reverse
distributor. The same DOT shipping
requirements would continue to apply
to shipments of potentially creditable
hazardous waste pharmaceuticals
(provided they are classified as DOT
hazardous materials) that applied prior
to this final rule. Nothing in this final
rule changes how DOT shipping
requirements apply to shipments of
prescription pharmaceuticals to reverse
distributors.
EPA proposed an alternate tracking
method for potentially creditable
hazardous waste pharmaceuticals-with
two requirements in lieu of requiring a
hazardous waste manifest and the use of
hazardous waste transporters. First, EPA
proposed that for each shipment,
healthcare facilities and reverse
distributors must provide in writing (via
letter or electronic communication),
advance notice of the intent to send a
shipment to the receiving reverse
distributor. We also proposed that the
receiving reverse distributor must
provide acknowledgement to the
shipper that they received the advance
notice. This requirement was intended
to function like a manifest, tracking the
potentially creditable hazardous waste
pharmaceuticals en route to the reverse
distributor. Second, EPA proposed that
for each shipment, the receiving reverse
distributor must provide confirmation to
the healthcare facility or reverse
distributor that initiated the shipment,
that the shipment of potentially
creditable hazardous waste
pharmaceuticals has been received. The
Agency proposed this requirement in
direct response to concerns expressed
by commenters over the lack of tracking
of pharmaceutical waste in the 2008
Pharmaceutical Universal Waste
proposal.
The Agency proposed that, if a
healthcare facility or reverse distributor
initiates a shipment of potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor
and does not receive delivery
confirmation within seven calendar
days, that the healthcare facility or
reverse distributor that initiated the
shipment must contact the shipper and
the intended recipient promptly to (1)
report that the confirmation was not
received, and (2) to determine the status
and whereabouts of the potentially
creditable hazardous waste
pharmaceuticals that were shipped.
The Agency proposed that if a
healthcare facility or reverse distributor
exports potentially creditable hazardous
waste pharmaceuticals, it must
generally comply with 40 CFR part 262
subpart E, except that it is not required
to manifest the potentially creditable
hazardous waste pharmaceuticals. The
Agency also proposed that any person
that imports potentially creditable
hazardous waste pharmaceuticals, must
comply with the proposed requirements
for the shipment of potentially
creditable hazardous waste
pharmaceuticals, in lieu of the
requirements for hazardous waste
imports found at 40 CFR part 262
subpart F.
355
EPA proposed to require healthcare
facilities (§
266.503(d)) and reverse
distributors (§
266.510(b)(4)) to keep
records of the shipments of potentially
creditable hazardous waste
pharmaceuticals to reverse distributors.
Specifically, we proposed that
healthcare facilities and reverse
distributors that initiate a shipment to a
reverse distributor must keep (1) records
of advance notification regarding
shipments of potentially creditable
hazardous waste pharmaceuticals, (2)
delivery confirmation for three years
after the shipment was initiated, and (3)
shipping papers or bills of lading. The
Agency argued that these records are
necessary to ensure that potentially
creditable hazardous waste
pharmaceuticals reach their intended
destination and are not diverted.
In most cases, retaining records for
three years should be sufficient for
inspection purposes; however, we
proposed that the periods of retention
would be automatically extended during
unresolved enforcement activity, or at
the request of the EPA Regional
Administrator. The Agency sought
comment on whether additional
recordkeeping is necessary to document
the cases when the reverse distributor
does not receive a shipment of
potentially creditable pharmaceuticals
within seven calendar days and the
steps must be taken to locate the
shipment.
2. Summary of Comments
The majority of comments focused on
the provision to allow shipments of
potentially creditable hazardous waste
pharmaceuticals to be sent via carrier
(i.e., not by hazardous waste
transporter), the requirements for
advance notice of shipment and
delivery confirmation, and the time
frame within which delivery
confirmation is received before the
shipper must take action to locate a
missing shipment.
Comments on whether the Agency
should allow shipments of potentially
creditable hazardous waste
pharmaceuticals to be sent via carriers
such as USPS, UPS, and FedEx without
a manifest were mixed. Only a few
states commented on this provision
specifically. The majority of states
agreed that shipping via carriers
provides sufficiently low risk of release
or illicit diversion. However, one state
was concerned that we did not propose
a requirement to reconcile the contents
of what was shipped with what was
received. That same commenter, as well
as a handful of others, also voiced
concern about whether DOT regulations
would permit hazardous waste
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See comment number EPA-HQ-RCRA-2007-
0932-0295.
357
See comment number EPA-HQ-RCRA-2007-
0932-0284.
358
See comment number EPA-HQ-RCRA-2007-
0932-0238.
pharmaceuticals to be lawfully shipped
via carrier in the first place.
Manufacturers, waste management
companies, healthcare industry groups,
and pharmacy trade associations were
all generally in agreement with the
proposed shipping standards for
potentially creditable hazardous waste
pharmaceuticals.
One of the primary points of
contention in this subsection was the
proposed standard that would require a
shipper to provide advance notice of its
intent to ship potentially creditable
hazardous waste pharmaceuticals to a
reverse distributor. Reverse distributors
objected, arguing it would impart undue
financial and administrative burden,
which would require them to hire
additional staff to adequately process
advance notices, track, and confirm the
delivery of thousands of shipments per
year. A national trade association of
retailers expressed similar concerns.
They did not support the proposed
advance notice and delivery
confirmation requirements and argued
the requirements would add undue
burden due to the high volume of
shipments large retailers send per year.
The commenters suggested that the
proposed notification and delivery
standards either be removed or modified
to match current inventory and
accounting practices.
356
One
pharmaceutical manufacturer also
disagreed with the proposed standard,
but gave no reasoning as to why, other
than they thought it was unnecessary.
States generally agreed with the
proposed standard and a few suggested
the Agency finalize additional
requirements like reconciling what was
in the notice with the contents of the
package after delivery which would also
require an inventory of each container.
One state was concerned about its
ability to confirm that a shipment has
reached its final destination (TSDF) in
scenarios where a shipment is sent to an
out-of-state reverse distributor or a
second reverse distributor. Healthcare
facilities and pharmacist trade groups
either agreed with the proposed
standards or did not mention these
standards specifically. One pharmacist
trade group said they want some
clarification about what constitutes
advance notice.
357
There were numerous comments both
in agreement with and opposition to the
proposed requirement to take action to
locate a shipment of potentially
creditable hazardous waste
pharmaceuticals if no delivery
confirmation is received within seven
days from the day the shipment leaves
the shipper's facility. Most comments
were related to the time frame within
which the shipper must receive delivery
confirmation, but a few commenters
from the retail and reverse distribution
industries opposed the requirement
altogether because of the added
financial, procedural, and
administrative burden they argue it
would impose. Many commenters were
concerned that the proposed time frame
was too short and would result in
frequent situations in which the shipper
would be required to undertake efforts
to locate a shipment that eventually
arrives without intervention sometime
after the seven days. Some commenters
noted that seven days is the minimum
transit time for a standard cross-country
shipment under ideal conditions, which
provides no buffer for unforeseen
circumstances that may cause delays
such as inclement weather or some
other service disruption. One state
suggested a 35-day time frame as an
alternative because it would be the same
as the time frame specified for delivery
confirmation of universal waste shipped
via carrier per the universal waste
rule.
358
There were limited comments
regarding the proposed standards for
healthcare facilities and reverse
distributors importing and/or exporting
potentially creditable hazardous waste
pharmaceuticals. The only concern
raised was whether shipments sent to or
received from U.S. territories (e.g.,
Puerto Rico, Guam) are considered
exports/imports, and if so, they
recommended that the Agency confer
with other appropriate federal agencies
and their reverse distributor contractors.
3. Final Rule Provisions
In response to comments, the Agency
has made several changes to the
proposed standards for shipping
potentially creditable hazardous waste
pharmaceuticals. First, we have made a
minor change to make our regulatory
language more consistent with DOT's
terminology and clarify to whom the
regulations refer. Specifically, in
§
266.509(c), we changed the word
shipper to carrier. As originally
proposed, the word shipper could have
been interpreted to refer to the party
that prepares and offers a shipment of
potentially creditable hazardous waste
pharmaceuticals, whereas the
regulations apply to the company
providing transportation of a shipment
of potentially creditable hazardous
waste pharmaceuticals. To clarify, a
shipper is the party that prepares and
offers a shipment to be transported by
a carrier.
Second, we have eliminated the
requirement in §
266.509(a)(1) for a
healthcare facility or reverse distributor
that ships potentially creditable
hazardous waste pharmaceuticals to
provide advance notice of the shipment.
The Agency believes that the proposed
advance notice requirement goes
beyond the manifest requirements and
would have resulted in undue burden
on both the shippers and the receiving
reverse distributors while only
nominally more protective of human
health and the environment. We would,
however, recommend that, as a best
practice, shippers of potentially
creditable hazardous waste
pharmaceuticals provide advance notice
to the recipients to the extent
practicable. Conforming changes have
been made throughout the regulations
that reflect the elimination of the
requirement to provide advance notice
of shipments of potentially creditable
hazardous waste pharmaceuticals.
Third, the proposed requirement that
a reverse distributor that receives a
shipment of potentially creditable
hazardous waste pharmaceuticals must
provide delivery confirmation to the
facility that initiated the shipment is
being finalized as proposed, with the
added clarification that the shipment is
not considered delivered until it is
under the custody and control of the
receiving reverse distributor. Requiring
delivery confirmation provides
assurance that the shipment was
actively received by the reverse
distributor and the chain of custody
maintained. Without this confirmation
from the receiving reverse distributor
personnel, it is possible for a shipment
to be delivered to the destination
location but not necessarily taken into
their custody and control (e.g., left
unattended outside the building).
Under this final rule, healthcare
facilities and reverse distributors may
use carriers, such as USPS, UPS, and
FedEx for shipments of potentially
creditable hazardous waste
pharmaceuticals to and between reverse
distributors, as long as personnel are
present to receive and take control of
the shipments upon arrival. EPA
believes that carriers are able to provide
safe shipment since these potentially
creditable hazardous waste
pharmaceuticals present low risk of
release during transport.
In addition, all of the carriers EPA is
aware of offer services that meet the
delivery confirmation requirement.
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See comment number EPA-HQ-RCRA-2007-
0932-0268.
360
March 31, 2016; 62 FR 18527.
Delivery confirmation can be paper-
based or electronic and must indicate
that personnel from the receiving
reverse distributor have taken the
shipment into their custody and control.
One way for healthcare facilities and
reverse distributors sending shipments
of potentially creditable hazardous
waste pharmaceuticals to a reverse
distributor via carrier may comply with
the delivery confirmation requirement
would be to utilize the delivery
confirmation service provided by most
carriers (e.g., Return Receipt from USPS,
Delivery Confirmation from UPS, or
Signature Proof of Delivery from FedEx).
Typically, personnel at the receiving
reverse distributor will sign for a
shipment confirming that it is now in
their custody and control. That
signature will then be made available to
the shipper, which satisfies the delivery
confirmation requirement.
EPA has learned that some
stakeholders use alternative electronic
tracking methods outside of those
offered by carriers. One alternative
electronic tracking method is to apply
barcoding on pharmaceutical packaging
or on containers containing multiple
pharmaceutical packages. A barcode is a
unique identifier that links the
container to a database with detailed
information about its contents and
includes the exact quantities of each
item included in the shipment
(inventories). Typically, when a reverse
distributor receives a barcoded
shipment, it will scan the barcodes
upon receipt, and the sender will
receive electronic notification that the
shipment has arrived at its destination
and is in the custody and control of the
reverse distributor. This type of barcode
tracking would meet the delivery
confirmation requirement of this final
rule. Another type of alternative
electronic tracking that would satisfy
the delivery confirmation requirement is
radio frequency identification (RFID).
Similar to barcodes, RFID tags are
placed inside a container, or integrated
into the container itself, and linked to
inventories and other detailed
information. The RFID tags are read
when they arrive at the receiving facility
and that information is made available
to the shipper, confirming that the
shipment has been taken into the
custody and control of the receiving
reverse distributor.
359
Fourth, we have eliminated the
regulatory language that was proposed
in §
266.509(a)(2). We had referenced
the DOT pre-transport regulations that
apply to shipments of non-creditable
hazardous waste pharmaceuticals.
However, in 2016, DOT revised the
Hazardous Materials Regulations (HMR)
as they apply to shipments of items in
reverse logistics.
360
As a result, many of
the DOT pre-transport requirements we
had referenced no longer apply to
shipments of hazardous materials in
reverse logistics. In response, we have
eliminated the reference to the DOT pre-
transport requirements and instead
modified our final regulations in
§
266.509(a) to refer to the entire HMR,
rather than specific provisions within
the HMR. Healthcare facilities and
reverse distributors that send shipments
of potentially creditable hazardous
waste pharmaceuticals to reverse
distributors need only comply with the
applicable sections of DOT's HMR for
shipments in reverse logistics.
We note that healthcare facilities and
reverse distributors must meet the
applicable DOT hazardous material
shipping requirements only when
shipping potentially creditable
hazardous waste pharmaceuticals that
meet the definition of DOT hazardous
material. Under the DOT regulations, a
RCRA hazardous waste that requires a
manifest is considered a Class 9
hazardous material. Potentially
creditable hazardous waste
pharmaceuticals do not require a
manifest; therefore, the DOT shipping
requirements will apply when
potentially creditable hazardous waste
pharmaceuticals are shipped to reverse
distributors only when the hazardous
wastes are otherwise classified as DOT
hazardous materials (i.e., DOT hazard
class 1-8). We added regulatory
language (that was adapted from the
Universal Waste regulations) to reflect
this.
Fifth, the Agency has finalized the
requirement that the shipper of
potentially creditable hazardous waste
pharmaceuticals must receive a delivery
confirmation from the reverse
distributor, however, the Agency has
extended the time frame within which
the shipper must receive the delivery
confirmation from the reverse
distributor from the proposed seven
days to 35 days, after which the shipper
must begin taking actions to locate a
shipment if the delivery confirmation is
not received. Many commenters
suggested 14 days as an alternative to
the proposed seven-day time frame,
while others suggested far longer or to
eliminate the time frame altogether.
Upon reconsideration of the issue and
how it pertains more generally to other
RCRA hazardous waste programs, the
Agency decided that 35 days was more
appropriate, while remaining duly
protective of human health and the
environment and reducing burden on
the regulated community. The time
frame to receive delivery confirmation
for shipments of potentially creditable
hazardous waste pharmaceuticals is also
now in line with the standard for
delivery confirmation under universal
waste, which is also 35 days. In
addition, one of the overarching goals of
this rule was to enact universal waste-
like standards for hazardous waste
pharmaceuticals, to which this
provision conforms. Some states wanted
the Agency to go further and require
that the EPA Regional Administrator be
notified whenever a shipment has not
been received within the allotted time
frame. Although the Agency
understands the utility of such a
provision, it is not being adopted
because of the added burden it would
impose on both states and the regulated
community. In addition, the Agency
prefers, in this instance, to allow states
the flexibility to implement more
stringent reporting standards for missing
shipments of potentially creditable
hazardous waste pharmaceuticals
according to their individual
circumstances and preferences.
After considering these comments, the
Agency determined that it is necessary
to require a delivery confirmation in
order to ensure shipments of potentially
creditable hazardous waste
pharmaceuticals have been received and
taken into the custody and control of the
destination facility as a way to
approximate the manifest system
without requiring the use of hazardous
waste transporters or manifests. In
response to comments, we have
reconsidered the proposed seven-day
time frame for the shipper to receive
delivery confirmation; the Agency
decided that 35 days is more
appropriate. It strikes a balance between
being duly protective of human health
and the environment, reducing burden,
and is now in line with universal waste
standards.
Sixth, we have made several changes
to the pre-transport requirements that
we proposed in §
266.509(a)(1) and (2).
Because of the removal of the
requirement for advance notice of
shipments of potentially creditable
hazardous waste pharmaceuticals, we
renumbered the section such that it all
appears in §
266.509(a) now. What was
proposed in §
266.509(a)(2) and is now
in §
266.509(a), has been modified to
reflect the removal of §
266.508(a)(1)(v)
which previously contained a
requirement that DOT shipping papers
be generated. The Agency believes that
the shipping papers requirement-
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361
See the Hazardous Waste Export-Import
Revisions final rule, 81 FR 85696; December 31,
2016.
362
See comment number EPA-HQ-RCRA-2007-
0932-0284.
363
This definition is derived from the definition
of ''business rules'' in the ''Surplus Household
Consumer Products and Wastes: Report to the
Legislature.'' Available at: http://www.dtsc.ca.gov/
HazardousWaste/Retail_Industry/upload/SB423_
Final-Rpt.pdf.
although duplicative for shipments of
non-creditable hazardous waste
pharmaceuticals from a healthcare
facility or evaluated hazardous waste
pharmaceuticals from a reverse
distributor-is appropriate for
shipments of potentially creditable
hazardous waste pharmaceuticals given
that they are not manifested. Therefore,
the requirement for DOT shipping
papers has been added to §
266.509(a).
Language was also added to clarify that
shipments of potentially creditable
hazardous waste pharmaceuticals from a
healthcare facility or reverse distributor
to a reverse distributor do not require a
manifest. This language was taken from
the universal waste standards in
§
273.52(a) which is consistent with the
goal of developing universal waste-like
shipping standards for potentially
creditable hazardous waste
pharmaceuticals.
As with the export of non-creditable
hazardous waste pharmaceuticals, the
proposed standards for healthcare
facilities or reverse distributors that
export potentially creditable hazardous
waste pharmaceuticals to a foreign
destination have also been modified to
reflect the changes made to the import/
export rules of part 262. Specifically,
the Agency is finalizing requirements
that exporters of potentially creditable
hazardous waste pharmaceuticals must
comply will all applicable sections of 40
CFR part 262 subpart H, except for the
manifest requirements of §
262.83(c), in
addition to the requirements for
shipping potentially creditable
hazardous waste pharmaceuticals in
§
266.509(a) through (c).
Subsequent to when this rule was
proposed in September 2015, the
Hazardous Waste Import-Export
Revisions rule was finalized in 2016.
361
As a result, the Agency has had to make
conforming changes to this final rule to
reflect the changes made by the Import-
Export Revisions final rule. Because the
regulations for importing and exporting
hazardous waste were previously
located in separate subparts-exports in
subpart E and imports in subpart F-the
proposed requirements in this rule were
also separated into discreet subsections
and referred to their respective subparts
(exporting and importing) of 40 CFR
part 262. A significant change enacted
by the Import-Export Revisions Rule
was to consolidate into subpart H the
multiple related subparts in 40 CFR 262
regarding import, export, and
transboundary movements of hazardous
waste that had been in subparts E and
F.
The essence of the proposed
regulations has not changed in the
finalized requirements. That is, a
healthcare facility or reverse distributor
exporting potentially creditable
hazardous waste pharmaceuticals is still
subject to the same or similar provisions
as were proposed, only now they must
comply with 40 CFR part 262 subpart H
instead, except for the manifesting
requirements, and paragraphs (a)
through (c) of §
266.509.
For healthcare facilities and reverse
distributors that import potentially
creditable hazardous waste
pharmaceuticals, the requirements are
being finalized as proposed, except that
due to the conforming changes
necessitated by the Hazardous Waste
Export-Import Revisions Final Rule,
they must now comply with the
shipping standards for potentially
creditable hazardous waste
pharmaceuticals in lieu of 40 CFR part
262 subpart H (instead of part 262
subpart F). One other clarification was
added to the regulatory language
specifying that potentially creditable
hazardous waste pharmaceuticals are
subject to all applicable provisions in
this subpart immediately after entering
the United States.
4. Comments and Responses
The commenter that requested an
official definition of advance notice also
requested an official definition for
delivery confirmation.
362
The Agency is
purposely leaving this standard
sufficiently broad as to allow the
implementing agencies discretion to
determine the best implementation
strategies on a case-by-case basis.
EPA notes that a reverse distributor is
not required to segregate the potentially
creditable hazardous waste
pharmaceuticals from the potentially
creditable non-hazardous waste
pharmaceuticals when they are destined
for another reverse distributor.
However, if the potentially creditable
pharmaceuticals are not segregated, the
reverse distributor must follow the
tracking procedures for the entire
shipment. On the other hand, if a
reverse distributor chooses to segregate
the potentially creditable hazardous
waste pharmaceuticals from the non-
hazardous waste pharmaceuticals prior
to shipping to another reverse
distributor, only the potentially
creditable hazardous waste
pharmaceutical portion would have to
be shipped according to these standards.
XVII. Standards for Reverse
Distributors (§
266.510)
A. Background on Reverse Distributor
Operations
Reverse distributors act as
intermediaries between healthcare
facilities and pharmaceutical
manufacturers. They receive shipments
of potentially creditable hazardous
waste pharmaceuticals from healthcare
facilities and, on behalf of
manufacturers, facilitate the process of
crediting healthcare facilities for these
pharmaceuticals. From stakeholder
input, EPA site visits, and comments on
the proposed rulemaking, EPA's
understanding is that when a reverse
distributor receives a shipment of
potentially creditable hazardous waste
pharmaceuticals, the reverse distributor
sorts through the shipment and often
uses barcodes to scan items into its
computer system. Based on
manufacturers' ''business rules'' (i.e.,
manufacturers' return policies), the
reverse distributors determine which
potentially creditable hazardous waste
pharmaceuticals can receive
manufacturer credit, as well as which
must be sent on to another reverse
distributor for completion of the
crediting process. ''Business rules'' (i.e.
manufacturers' return policies) refers to
the rules that govern the disposition of
retail items agreed to by the
manufacturer, retailer, and reverse
distributor or reverse logistics center.
363
In many cases, there is more than one
reverse distributor involved in
establishing and verifying manufacturer
credit for a particular potentially
creditable hazardous waste
pharmaceutical. For instance, reverse
distributors may have contracts with
specific pharmaceutical manufacturers
such that only a specific reverse
distributor may facilitate credit for a
particular manufacturer's
pharmaceuticals. If the receiving reverse
distributor has a contract with the
healthcare facility, but not with the
pharmaceutical manufacturer, then the
receiving reverse distributor sends the
returned pharmaceutical on to the
reverse distributor that has a contract
with the pharmaceutical manufacturer
in order to facilitate the manufacturer
credit process.
Because manufacturers' business rules
change over time, sometimes a reverse
distributor receives a potentially
creditable hazardous waste
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Several DEA reverse distributors have RCRA
interim status or a permit to treat or dispose of
hazardous waste, but these DEA reverse distributors
do not facilitate manufacturer credit.
365
Barnes, K.K., Christenson, S.C., Kolpin, D.W.,
Focazio, M.J., Furlong, E.T., Zaugg, S.D., Meyer,
M.T. and Barber, L.B. (2004), Pharmaceuticals and
Other Organic Waste Water Contaminants Within a
Leachate Plume Downgradient of a Municipal
Landfill. Groundwater Monitoring & Remediation,
24: 119-126.
366
Buszka, P.M., Yeskis, D.J., Kolpin, D.W.,
Furlong, E.T., Zaugg, S.D., and Meyer, M.T. (2009),
Waste-Indicator and Pharmaceutical Compounds in
Landfill-Leachate-Affected Ground Water near
Elkhart, Indiana, 2000-2002. Bulletin of
Environmental Contamination and Toxicology,
82.6:635-659.
pharmaceutical that is not eligible for
credit immediately, and the reverse
distributor retains the potentially
creditable hazardous waste
pharmaceutical on site until it is credit
eligible (often called ''aging'' a
pharmaceutical). For example,
manufacturers only issue credit for
expired pharmaceuticals. As a result,
sometimes a reverse distributor receives
an unexpired hazardous waste
pharmaceutical that is otherwise
creditable but awaiting its expiration
date. The reverse distributor then
retains the potentially creditable
hazardous waste pharmaceutical on site
until after it has expired and thus
becomes eligible for manufacturer
credit. In some cases, even after the
reverse distributor has awarded
manufacturer credit, a pharmaceutical
manufacturer may request that the
hazardous waste pharmaceuticals be
transported back to the manufacturer to
verify the amount of pharmaceuticals
and manufacturer credit.
On the other hand, if the potentially
creditable hazardous waste
pharmaceuticals are not sent on to
another reverse distributor and the
reverse distributor awards the
manufacturer credit to the healthcare
facility itself, it then manages the
hazardous waste pharmaceuticals on
site until they are sent off site for
treatment and disposal. As discussed
previously, after a potentially creditable
hazardous waste pharmaceutical has
been evaluated and no additional
reverse distributors will be involved in
the manufacturer's crediting process,
EPA uses the term ''evaluated hazardous
waste pharmaceutical.'' This is to
distinguish between the potentially
creditable hazardous waste
pharmaceuticals awaiting determination
within the reverse distribution system
versus the evaluated hazardous waste
pharmaceuticals that will not be sent to
another reverse distributor for
evaluation. Both are considered
hazardous waste pharmaceuticals, but
they are managed differently under this
subpart.
EPA is not aware of any reverse
distributor that facilitates manufacturer
credit that also has interim status or a
permit to treat or dispose of hazardous
waste on-site.
364
Therefore, EPA
anticipates that reverse distributors
eventually send all evaluated hazardous
waste pharmaceuticals off site for
treatment and disposal.
B. EPA's Rationale for Finalizing New
RCRA Management Standards for
Reverse Distributors
This final rule establishes standards
for the management of both potentially
creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals that
reverse distributors receive and manage.
The management standards discussed in
this section apply only to reverse
distributors of prescription
pharmaceuticals that are potentially
creditable hazardous waste
pharmaceuticals or evaluated hazardous
waste pharmaceuticals. The
management standards discussed in this
section do not apply to the reverse
logistics systems that may exist for other
retail items. In response to comments,
EPA is codifying our existing
interpretation that nonprescription
pharmaceuticals that are sent through
reverse logistics are not solid wastes at
the retail store if they have a reasonable
expectation of being legitimately used/
reused (e.g., lawfully redistributed for
their intended purpose) or reclaimed
(see the definition of hazardous waste
pharmaceutical under section VIII and
section IX, the applicability section).
Additionally, EPA is establishing a
policy that other retail items that are
sent through reverse logistics are not
solid waste at the retail store if they
have a reasonable expectation of being
legitimately used/reused or reclaimed
(see section VI). Therefore, reverse
logistics centers that receive and
manage nonprescription
pharmaceuticals will not be regulated
under this subpart and will not be
subject to the standards for reverse
distributors.
The current federal RCRA hazardous
waste generation regulations at 40 CFR
part 262 provide that only designated
facilities, such as RCRA-permitted and
interim status TSDFs, may receive
hazardous waste from off site for
treatment, storage, or disposal.
However, the Agency does not believe it
is necessary for reverse distributors to
obtain permits or have interim status to
store hazardous waste pharmaceuticals
in order to protect human health and
the environment. Thus, EPA is
finalizing a new category of hazardous
waste management facilities under
RCRA called a ''reverse distributor,''
which is defined as any person that
receives and accumulates prescription
pharmaceuticals that are potentially
creditable hazardous waste
pharmaceuticals for the purpose of
facilitating or verifying manufacturer
credit. The definition specifies that any
person, including forward distributors,
third-party logistics providers, and
pharmaceutical manufacturers, that
processes prescription hazardous waste
pharmaceuticals for the facilitation or
verification of manufacturer credit is
considered a reverse distributor. EPA is
finalizing that reverse distributors are
not required to have interim status or a
RCRA permit to accumulate hazardous
waste pharmaceuticals and they may
only accept potentially creditable
hazardous waste pharmaceuticals from
off site provided they comply with the
standards in this final rule. Reverse
distributors may not treat or dispose of
hazardous waste on-site unless
authorized to do so as a RCRA-
permitted or interim status TSDF.
As discussed earlier in this document,
EPA's previous interpretation allows
reverse distributors to be generators of
hazardous waste pharmaceuticals after a
decision is made about whether the
pharmaceuticals will be repurposed. As
a hazardous waste generator, a reverse
distributor had to comply with the LQG,
SQG, or VSQG generator regulations,
depending on the total volume of
hazardous waste generated in a calendar
month. Some smaller reverse
distributors might have stayed under the
hazardous waste quantity limits for
VSQGs, which would mean that under
the federal RCRA regulations, these
VSQG reverse distributors would not
have had to notify EPA as a generator
and their hazardous waste
pharmaceuticals could be disposed of
with municipal and non-municipal
solid waste (see §
262.14). However, the
Agency has concerns with VSQG
reverse distributors not notifying EPA
that they are managing hazardous waste.
EPA is even more concerned about
reverse distributors that currently
qualify as VSQGs placing the hazardous
waste pharmaceuticals into the
municipal and non-municipal solid
waste stream and sending them to non-
hazardous waste landfills. Some studies
have shown active pharmaceutical
ingredients present in landfill leachate
that is collected in municipal solid
waste landfill leachate systems.
365
366
Landfill leachate is generally
transported to a wastewater treatment
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See EPA's request of information from reverse
distributors, as well as their responses to EPA in the
docket for this rulemaking: EPA-HQ-RCRA-2007-
0932-0157, EPA-HQ-RCRA-2007-0932-0158,
EPA-HQ-RCRA-2007-0932-0159, EPA-HQ-
RCRA-2007-0932-0160, EPA-HQ-RCRA-2007-
0932-0161, EPA-HQ-RCRA-2007-0932-0162,
EPA-HQ-RCRA-2007-0932-0163, EPA-HQ-
RCRA-2007-0932-0164.
368
Meeting with representatives from CVS
(August 11, 2012); see the docket for meeting notes
(EPA-HQ-RCRA-2007-0932-0188).
369
See the Regulatory Impact Analysis in the
docket for this rulemaking (EPA-HQ-RCRA-2007-
0932).
plant to be treated before discharge;
however, some pharmaceutical
compounds pass through treatment and
are discharged, becoming a potential
contributor of the pharmaceutical
compounds detected in our nation's
waters.
In this final rule, EPA is revising its
position regarding prescription
pharmaceuticals that are potentially
creditable hazardous waste
pharmaceuticals, such that they will be
considered discarded at the healthcare
facilities, not at the reverse distributors.
This revision is based on new
information demonstrating to EPA that
prescription pharmaceuticals returned
to a reverse distributor are rarely, if
ever, recycled or reused, and therefore
the decision to send a potentially
creditable hazardous waste
pharmaceutical to a reverse distributor
is a decision to discard the
pharmaceutical (as discussed previously
in section VI). Comments on the
December 2008 Pharmaceutical
Universal Waste proposal indicated that
notification to EPA by reverse
distributors and tracking of shipments
of potentially creditable hazardous
waste pharmaceuticals are critical and
must be included in any regulatory
scheme to ensure the safe management
of potentially creditable hazardous
waste pharmaceuticals.
Although EPA maintains its position
as stated in the proposed rulemaking
preamble that hazardous waste
pharmaceuticals going to reverse
distributors are solid wastes at the
healthcare facility, there are important
differences between reverse distributors
and traditional TSDFs. Only between 2-
6 percent of the potentially creditable
pharmaceuticals that are received by
reverse distributors are listed or
characteristic hazardous wastes.
367
Therefore, the vast majority of the
potentially creditable pharmaceutical
waste that a reverse distributor receives
is not considered a characteristic or
listed hazardous waste pharmaceutical
under the existing definition of
hazardous waste. This stands in contrast
to a typical TSDF, whose primary
function is to manage hazardous waste.
As a result, a reverse distributor
generally manages a smaller volume of
hazardous waste than a typical
permitted TSDF.
In addition, because the
pharmaceuticals in the reverse
distribution system are receiving
manufacturer credit, they are moved
through the system efficiently. In fact,
one national pharmacy retail chain
informed EPA that the value of the
credit they receive from manufacturers
for returned pharmaceuticals is
approximately $1 billion a year.
368
Healthcare facilities and reverse
distributors have a vested interest in
having potentially creditable hazardous
waste pharmaceuticals processed and
credited quickly and managed
appropriately so money is not lost in the
process.
Furthermore, potentially creditable
hazardous waste pharmaceuticals
generally present a low risk of release to
the environment as they typically are
still in the manufacturer's packaging,
which in some cases includes inner and
outer packaging (e.g., plastic bottle
inside a box). Since there is a relatively
low human health and environmental
risk of release associated with the low
volumes of potentially creditable
hazardous waste pharmaceuticals
shipped to reverse distributors for
crediting purposes, and because EPA is
not aware of any incidents of
mismanagement resulting in
environmental harm or releases of
hazardous waste pharmaceuticals by
reverse distributors, EPA believes that it
is not necessary to require reverse
distributors to obtain RCRA hazardous
waste storage permits with respect to
typical reverse distribution operations,
such as receiving, sorting, consolidating,
and reshipping potentially creditable
hazardous waste pharmaceuticals.
Thus, EPA is taking a tailored
approach to regulating reverse
distributors by regarding them as a new
type of RCRA hazardous waste entity-
a reverse distributor. This approach
balances EPA's revised interpretation
that the point of generation for
prescription pharmaceuticals that are
potentially creditable hazardous waste
pharmaceuticals is at the healthcare
facility, not the reverse distributor, with
the fact that potentially creditable
hazardous waste pharmaceuticals have
value which provides an incentive for
proper management.
EPA is establishing new management
standards for reverse distributors in 40
CFR part 266 subpart P. These entities
will not be subject to 40 CFR parts 262,
264, 265, or 270. Generally, EPA is
finalizing that reverse distributors
comply with standards that are similar
to the current federal LQG standards, in
combination with certain requirements
that permitted or interim status
hazardous waste TSDFs must meet. We
are establishing one set of requirements
for all reverse distributors, regardless of
the amount of potentially creditable
hazardous waste pharmaceuticals they
receive. EPA believes this uniform set of
standards will make it easier for reverse
distributors to comply with the new
subpart, in part because the burden of
having to count hazardous waste
pharmaceuticals on a monthly basis,
especially the 1 kg of acute hazardous
waste pharmaceuticals, will be
removed.
EPA is finalizing that a reverse
distributor will not be required to have
a hazardous waste permit or interim
status for on-site accumulation of
creditable and evaluated hazardous
waste pharmaceuticals provided it
follows the final reverse distributor
standards. As mentioned previously, the
on-site accumulation of creditable and
evaluated hazardous waste
pharmaceuticals generally presents low
risk of release to the environment
because they are typically in the
manufacturer's packaging. However, for
activities such as treatment or disposal
of hazardous waste pharmaceuticals or
other hazardous waste, a reverse
distributor must either obtain a RCRA
permit or have interim status, as these
activities pose a higher risk of release.
EPA has determined that requirements
similar to LQG standards for on-site
accumulation of hazardous waste that
are found in §
262.17 are appropriate.
As discussed previously, the value of
the potentially creditable
pharmaceuticals creates an incentive for
proper management and the risk of
release is low. Furthermore, many
reverse distributors are already LQGs
and, therefore, this final rule should not
represent a large shift in current
practices or increased burden.
369
However, once credit is provided, the
value of the pharmaceuticals is
eliminated and therefore the evaluated
hazardous waste pharmaceuticals have a
greater potential for mismanagement. As
a result, EPA is finalizing additional
standards for the management of
evaluated hazardous waste
pharmaceuticals at reverse distributors.
EPA received numerous comments
that expressed concern that the
standards for reverse distributors would
be burdensome for reverse logistics
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See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
371
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
372
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
373
See comment numbers EPA-HQ-RCRA-2007-
0932-0235, EPA-HQ-RCRA-2007-0932-0257,
EPA-HQ-RCRA-2007-0932-0280, EPA-HQ-
RCRA-2007-0932-0296, EPA-HQ-RCRA-2007-
0932-0300, and EPA-HQ-RCRA-2007-0932-0341
in the docket for this rulemaking.
374
See comment number EPA-HQ-RCRA-2007-
0932-0235 in the docket for this rulemaking.
375
See comment number EPA-HQ-RCRA-2007-
0932-0295 in the docket for this rulemaking.
centers that handle nonprescription
pharmaceuticals. For example, one
commenter expressed concern that the
reverse distributor inventory
requirements for both potentially
creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals would
be burdensome for facilities that receive
and manage nonprescription
pharmaceuticals because these reverse
logistics centers do not currently
maintain an inventory for these retail
items.
370
EPA is codifying our existing
interpretation that nonprescription
pharmaceuticals that are sent through
reverse logistics are not solid wastes at
the retail store if they have a reasonable
expectation of being legitimately used/
reused (e.g., lawfully redistributed for
their intended purpose) or reclaimed
(see section VI for more discussion).
Therefore, reverse logistics centers will
not be regulated under part 266 subpart
P and will not be subject to the
standards for reverse distributors. As a
result, comments received on the impact
of the reverse distributor standards on
reverse logistics centers that receive and
manage nonprescription
pharmaceuticals are outside the scope of
the final rule and are not discussed in
this section. EPA also received
numerous general comments expressing
concern that finalizing new RCRA
management standards for reverse
distributors would be burdensome.
However, some specific provisions
included in the proposed reverse
distributor standards received few
comments.
C. Detailed Discussion of Final Reverse
Distributor Standards
The final standards for reverse
distributors are organized into three
sections. The first section applies to the
reverse distributor for the management
of all potentially creditable hazardous
waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals
(§
266.510(a)). The second section
includes additional standards that
would apply to the management of the
potentially creditable hazardous waste
pharmaceuticals that will be sent to
another reverse distributor for further
evaluation or verification of credit and
therefore continue to be regulated as
potentially creditable hazardous waste
pharmaceuticals (§
266.510(b)). The
third section includes additional
standards that apply to the management
of the evaluated hazardous waste
pharmaceuticals that will not be sent to
another reverse distributor, but instead
will be sent to a permitted or interim
status TSDF (§
266.510(c)).
1. Standards for Reverse Distributors
Managing Potentially Creditable
Hazardous Waste Pharmaceuticals and
Evaluated Hazardous Waste
Pharmaceuticals (§
266.510(a))
This portion of the preamble
discusses the standards that apply to
reverse distributors for the management
of all hazardous waste pharmaceuticals
on site, including potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals. Unlike the following
two sections, the standards discussed in
this section apply to all prescription
hazardous waste pharmaceuticals at a
reverse distributor, regardless of the
subsequent destination of the hazardous
waste pharmaceuticals. We note that a
reverse distributor must follow these
standards for the management of
hazardous waste pharmaceuticals even
if it generates other, non-pharmaceutical
hazardous waste that is managed under
40 CFR part 262. Note that we have
reorganized §
266.510(a) since the
proposal to more accurately reflect the
flow of hazardous waste
pharmaceuticals at a reverse distributor.
The subsequent preamble section
follows the organization of the final
regulations.
a. Notification
Summary of Proposal. EPA proposed
that a reverse distributor must notify
EPA of its hazardous waste
pharmaceutical activities using the Site
ID Form (EPA Form 8700-12). Under
the RCRA Subtitle C program, SQGs,
LQGs, and TSDFs must submit a Site ID
Form to EPA. EPA proposed that a
reverse distributor that does not have an
EPA ID number will be required to
submit the Site ID Form to obtain one
and that a reverse distributor that
already has an EPA ID number will need
to notify EPA as a reverse distributor.
Summary of Comments. EPA received
two comments in support of the
proposed notification requirements. One
state supported all of the proposed
notification requirements.
371
Inmar, Inc.
supported the requirement that reverse
distributors must notify EPA using EPA
Form 8700-12.
372
Final Rule Provisions. EPA is
finalizing in §
266.510(a)(1) that a
reverse distributor must notify EPA of
its hazardous waste pharmaceutical
activities using the Site ID Form (EPA
Form 8700-12). The Agency will revise
the Site ID Form to include a box to
allow notifications by reverse
distributors. EPA believes it is
appropriate, and in line with comments
received on the proposal, to require
reverse distributors to notify EPA.
Under the final rule, a reverse
distributor that does not have an EPA ID
number will be required to submit the
Site ID Form to obtain one. A reverse
distributor that already has an EPA ID
number will need to notify EPA as a
reverse distributor. The time frame in
both cases is within 60 days of the
effective date of this subpart or within
60 days of becoming subject to this
subpart. Some reverse distributors may
also be generators of other types of
hazardous waste (e.g., from cleaning and
maintenance operations). Therefore, it is
possible that a reverse distributor may
notify on the same notification form as
both a generator of hazardous waste and
as a reverse distributor.
b. Inventory
Summary of Proposal. EPA proposed
that reverse distributors must keep an
inventory of the potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals that are on site. EPA
proposed that the inventory must
include the identity (e.g., name or
National Drug Code) and quantity of
each potentially creditable hazardous
waste pharmaceutical and evaluated
hazardous waste pharmaceutical. EPA
also proposed that a reverse distributor
must inventory each potentially
creditable hazardous waste
pharmaceutical upon arrival at the
reverse distributor.
Summary of Comments. EPA received
comments from states and industry in
support of the proposed inventory
requirement.
373
One state suggested that
EPA also require reverse distributors to
include the name of the healthcare
facility that shipped the potentially
creditable hazardous waste
pharmaceuticals to the reverse
distributor.
374
Retail Industry Leaders Association
argued that the inventory requirements
for reverse distributors should be
reduced.
375
Inmar, Inc. did not support
the inventory requirements and argued
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See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
377
See the EPA correspondence with Inmar dated
March 29, 2017 in the docket for this rulemaking
EPA-HQ-RCRA-2007-0932.
378
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
379
See comment numbers EPA-HQ-RCRA-2007-
0932-0295, EPA-HQ-RCRA-2007-0932-0276,
EPA-HQ-RCRA-2007-0932-0352, and EPA-HQ-
RCRA-2007-0932-0340 in the docket for this
rulemaking.
380
See comment number EPA-HQ-RCRA-2007-
0932-0278 in the docket for this rulemaking.
381
Now renamed Heathcare Distribution
Alliance.
382
See comment number EPA-HQ-RCRA-2007-
0932-0276 in the docket for this rulemaking.
383
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
384
See EPA's request of information from reverse
distributors, as well as their responses to EPA in the
docket for this rulemaking: EPA-HQ-RCRA-2007-
0932-0157, EPA-HQ-RCRA-2007-0932-0158,
EPA-HQ-RCRA-2007-0932-0159, EPA-HQ-
RCRA-2007-0932-0160, EPA-HQ-RCRA-2007-
0932-0161, EPA-HQ-RCRA-2007-0932-0162,
EPA-HQ-RCRA-2007-0932-0163, EPA-HQ-
RCRA-2007-0932-0164.
385
See comment number EPA-HQ-RCRA-2007-
0932-0276 in the docket for this rulemaking.
that they are duplicative because reverse
distributors must already inventory and
track prescription pharmaceuticals.
376
Inmar, Inc. wrote that at least four states
currently require the maintenance of
drug inventories by law.
377
Both Inmar,
Inc. and RILA expressed concern that
the inventory requirements would be
particularly burdensome for their
facilities that handle nonprescription
pharmaceuticals. Inmar, Inc. pointed
out that their reverse logistics centers do
not maintain an inventory for
nonprescription pharmaceuticals.
378
EPA received multiple comments
from industry that expressed concern
that the reverse distributor must
inventory each potentially creditable
hazardous waste pharmaceutical upon
arrival.
379
One commenter expressed
concern that the reverse distributor
must complete an inventory upon
arrival because packages of potentially
creditable hazardous waste
pharmaceuticals can remain unopened
for up to 5 business days.
380
Healthcare
Distribution Management
Association
381
pointed out that reverse
distributors sometimes receive tens of
thousands of products in a day and do
individual product accounting when the
credit determination is made.
382
Commenters on the proposed
rulemaking also pointed out that reverse
distributors are already required to
inventory and track prescription
pharmaceuticals under licensing and
accreditation programs overseen by the
National Association of Boards of
Pharmacy.
383
Final Rule Provisions. EPA is
finalizing in §
266.510(a)(2) that reverse
distributors must keep an inventory of
the potentially creditable hazardous
waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals that
are on site. In response to comments, we
have made several changes to what was
proposed but have determined that an
inventory is a key requirement to
protect public health by helping to
prevent the diversion of hazardous
waste pharmaceuticals. An inventory
will allow the reverse distributor to
know which hazardous waste
pharmaceuticals they have on-site at
any time. Based on stakeholder input
and site visits, the Agency believes that
in many cases, reverse distributors
already maintain inventories of
pharmaceuticals and this requirement is
not expected to be burdensome for the
reverse distributors to implement.
According to responses from reverse
distributors to a 2011 request for
information, four out of eight of them
indicated that they already keep
inventories as best management
practices or because it is required by the
Board of Pharmacy in their state.
384
The
inventory must include the identity
(e.g., name or National Drug Code) and
quantity of each potentially creditable
hazardous waste pharmaceutical and
evaluated hazardous waste
pharmaceuticals. In response to
commenter concern that the inventory
requirement would be duplicative, EPA
clarified in the regulatory language of
the final rule that if the reverse
distributor already meets the inventory
requirements because of other
regulatory requirements, such as State
Board of Pharmacy regulations, the
facility is not required to provide a
separate inventory.
EPA proposed that a reverse
distributor must inventory each
potentially creditable hazardous waste
pharmaceutical upon arrival at the
reverse distributor. The final rule has
been revised to state that reverse
distributors must inventory each
potentially creditable hazardous waste
pharmaceutical within 30 calendar days
of arriving at the reverse distributor.
EPA made this change in response to
commenter concern that the Agency did
not provide enough time for reverse
distributors to inventory potentially
creditable hazardous waste
pharmaceuticals. As previously
mentioned, comments pointed out that
reverse distributors sometimes receive
tens of thousands of products in one day
and need additional time to inventory
each potentially creditable hazardous
waste pharmaceutical.
385
EPA is also
aware that many reverse distributors
inventory the potentially creditable
hazardous waste pharmaceutical at the
same time that they evaluate the
potentially creditable hazardous waste
pharmaceutical to determine if it will
receive manufacturer credit. When a
reverse distributor receives a shipment
of potentially creditable hazardous
waste pharmaceuticals, the reverse
distributor sorts through the shipment
and often uses barcodes to scan items
into its system and make a credit
determination. EPA believes that 30
days is an adequate amount of time for
the reverse distributor to sort through
shipments of hazardous waste
pharmaceuticals and inventory the
potentially creditable hazardous waste
pharmaceuticals. The Agency has
determined that because of the value of
the potentially creditable hazardous
waste pharmaceuticals, and the low risk
these materials present, increasing the
amount of time reverse distributors have
to complete the inventory will not
increase risk of release to the
environment.
c. Evaluating Potentially Creditable
Hazardous Waste Pharmaceuticals
Within 30 Days
Summary of Proposal. The key role
the reverse distributor plays in
managing the issuing of credit from a
manufacturer to a healthcare facility is
sorting through shipments of potentially
creditable hazardous waste
pharmaceuticals and evaluating them to
determine which must be transported to
another reverse distributor for further
evaluation of manufacturer credit and
which will be sent off site for treatment
and disposal. The reverse distributors
often use barcodes to scan items into
their systems.
EPA proposed that this evaluation
process must be completed within 21
days of arriving at the reverse
distributor. Likewise, EPA proposed
that if the reverse distributor is a
manufacturer, the manufacturer must
finish verifying the appropriate credit
within 21 calendar days of receiving the
shipment of potentially creditable
hazardous waste pharmaceuticals. The
Agency proposed that the 21 calendar
days for evaluating the potentially
creditable hazardous pharmaceuticals
counts as part of the total 90 calendar
days that each reverse distributor is
allowed to accumulate hazardous waste
pharmaceuticals on site.
Summary of Comments. The most
frequent comment EPA received on the
proposed requirement that reverse
distributors complete the evaluation
process within 21 days of arriving at the
reverse distributor is that the proposed
time frame was too short. Waste
Management National Services, Inc.
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386
See comment number EPA-HQ-RCRA-2007-
0932-0257 in the docket for this rulemaking.
387
See comment number EPA-HQ-RCRA-2007-
0932-0313 in the docket for this rulemaking.
388
See comment numbers EPA-HQ-RCRA-2007-
0932-0295 and EPA-HQ-RCRA-2007-0932-0349
in the docket for this rulemaking.
389
See comment numbers EPA-HQ-RCRA-2007-
0932-0336, EPA-HQ-RCRA-2007-0932-0352, and
EPA-HQ-RCRA-2007-0932-0296 in the docket for
this rulemaking.
390
See comment number EPA-HQ-RCRA-2007-
0932-0235 in the docket for this rulemaking.
391
See comment number EPA-HQ-RCRA-2007-
0932-0315 in the docket for this rulemaking.
392
See comment number EPA-HQ-RCRA-2007-
0932-0333 in the docket for this rulemaking.
393
See comment numbers EPA-HQ-RCRA-2007-
0932-0276 and EPA-HQ-RCRA-2007-0932-0257
in the docket for this rulemaking.
394
See comment number EPA-HQ-RCRA-2007-
0932-0276 in the docket for this rulemaking.
395
Although RILA requested that EPA allow
reverse distributors to have 60 days to complete the
evaluation process, RILA was primarily concerned
that it would be difficult for reverse distributors to
sort through over-the-counter pharmaceuticals and
dietary supplements within the proposed time
frame (see comment number EPA-HQ-RCRA-
2007-0932-0295 in the docket for this rulemaking).
However, the Agency thinks that 30 days is a
sufficient amount of time for reverse distributors to
sort through shipments of potentially creditable
hazardous waste pharmaceuticals, which does not
include over-the-counter pharmaceuticals and
dietary supplements under the final regulations (see
the definition of ''potentially creditable hazardous
waste pharmaceuticals'' in 266.500).
396
For more discussion of the closed container
standard see memo from Devlin to RCRA Division
Directors, November 3, 2011 (RCRA Online
#14826).
requested that EPA allow additional
time for reverse distributors to evaluate
potentially creditable hazardous waste
pharmaceuticals.
386
One state requested
that EPA allow reverse distributors to
have 30 days to complete the evaluation
process.
387
RILA and PharmaLink, Inc.
requested that EPA allow reverse
distributors to have 60 days to complete
the evaluation process.
388
GENCO,
Qualanex, LLC, and Healthcare Waste
Institute of the National Waste and
Recycling Association requested that
there be no time limit set for reverse
distributors to complete the evaluation
process.
389
One state suggested that it is
not critical to require the evaluation to
take place in a certain number of days
if the days count toward the total
number of days that hazardous waste
pharmaceuticals are allowed to
accumulate on site.
390
EPA also received multiple comments
in support of the requirement that
reverse distributors complete the
evaluation process in a short time frame.
One state supported the requirement
that reverse distributors complete the
evaluation process in a short time
frame.
391
Clean Harbors Environmental
Services argued that 21 days is more
than adequate for a reverse distributor to
evaluate potentially creditable
hazardous waste pharmaceuticals.
392
Final Rule Provisions. Under the final
rule, EPA is requiring in §
266.510(a)(3)
that reverse distributors evaluate
potentially creditable hazardous waste
pharmaceuticals within 30 calendar
days of arriving at the reverse
distributor. Likewise, EPA is finalizing
in §
266.510(a)(4) that if the reverse
distributor is a manufacturer, the
manufacturer must finish verifying the
appropriate credit within 30 calendar
days of receiving the shipment of
potentially creditable hazardous waste
pharmaceuticals.
EPA is now aware that reverse
distributors sometimes receive tens of
thousands of products in one day and
that sometimes reverse distributors need
more than 21 days to evaluate the
potentially creditable hazardous waste
pharmaceuticals.
393
As mentioned
previously, commenters pointed out
that many reverse distributors inventory
the potentially creditable hazardous
waste pharmaceuticals at the same time
that they evaluate the potentially
creditable hazardous waste
pharmaceuticals to determine if they
will be credited.
394
Therefore, the
Agency is finalizing that both the
inventory and the evaluation process
must be completed in 30 days to ensure
that reverse distributors have adequate
time to sort through shipments of
potentially creditable hazardous waste
pharmaceuticals.
395
In the case where
healthcare facilities do not segregate
hazardous waste pharmaceuticals from
non-hazardous waste pharmaceuticals
as part of the evaluation process, reverse
distributors will effectively make a
hazardous waste determination in order
to determine which pharmaceuticals are
hazardous waste pharmaceuticals and
thus subject to this subpart.
The Agency is finalizing that the 30
calendar days for evaluating the
potentially creditable hazardous
pharmaceuticals do not count as part of
the total 180 calendar days that the
hazardous waste pharmaceuticals are
allowed to accumulate on site at the
reverse distributor. The Agency has
determined that because of the value of
the potentially creditable hazardous
waste pharmaceuticals and the low risk
these materials present, increasing the
amount of time reverse distributors have
to evaluate shipments of potentially
creditable hazardous waste
pharmaceuticals will not increase risk of
release to the environment.
Additionally, because most potentially
creditable hazardous waste
pharmaceuticals are in their original
packaging, if the original packaging for
gels or liquids is intact and sealed or the
pharmaceuticals have been repackaged
(e.g., for unit dosing) and the
repackaged packaging for gels and
liquids is intact and sealed, they are
considered to meet the closed container
standard, and therefore EPA has
determined that having a longer
accumulation time is not a hazard to
human health and the environment.
396
EPA is finalizing that once an
evaluation is made on the incoming
potentially creditable hazardous waste
pharmaceuticals, if they are destined for
another reverse distributor, they are still
considered potentially creditable
hazardous waste pharmaceuticals. There
are additional regulations in this
subpart at §
266.510(b) that pertain to
these potentially creditable hazardous
waste pharmaceuticals. If, however,
they are destined for an interim status
or permitted TSDF, they are considered
''evaluated hazardous waste
pharmaceuticals.'' There are additional
regulations in this rule at §
266.510(c)
that pertain to these evaluated
hazardous waste pharmaceuticals.
d. Accumulation Time Limit
Summary of Proposal. EPA proposed
that, like LQGs, reverse distributors may
accumulate potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals on-site for up to 90
calendar days without having interim
status or a permit. However, because of
the value of the potentially creditable
hazardous waste pharmaceuticals, and
the low risk these materials present
because they are in original
manufacturer's packaging that would
meet our typical requirement for closed
containers, the Agency decided not to
propose specific container management
standards.
The Agency proposed that the 90-day
time limit begin when the potentially
creditable hazardous waste
pharmaceuticals initially arrive at the
reverse distributor. The Agency also
proposed that there is a 90-day
accumulation limit for the hazardous
waste pharmaceuticals at each reverse
distributor. Some potentially creditable
hazardous waste pharmaceuticals travel
through more than one reverse
distributor to receive manufacturer
credit. The Agency proposed that in
such cases, each reverse distributor that
receives the potentially creditable
hazardous waste pharmaceuticals has a
90-day accumulation limit.
EPA did not propose a specific
method that reverse distributors must
use to document that accumulation does
not exceed 90 calendar days. EPA
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397
See comment number EPA-HQ-RCRA-2007-
0932-0257 in the docket for this rulemaking.
398
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
399
See comment number EPA-HQ-RCRA-2007-
0932-0276 in the docket for this rulemaking.
400
See comment numbers EPA-HQ-RCRA-2007-
0932-0257, EPA-HQ-RCRA-2007-0932-0352, and
EPA-HQ-RCRA-2007-0932-0349 in the docket for
this rulemaking.
401
See comment number EPA-HQ-RCRA-2007-
0932-0280 in the docket for this rulemaking.
402
See comment numbers EPA-HQ-RCRA-2007-
0932-0336 and EPA-HQ-RCRA-2007-0932-0296
in the docket for this rulemaking.
403
See comment number EPA-HQ-RCRA-2007-
0932-0295 in the docket for this rulemaking.
404
See comment number EPA-HQ-RCRA-2007-
0932-0310 in the docket for this rulemaking.
405
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
406
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
407
See comment number EPA-HQ-RCRA-2007-
0932-0300 in the docket for this rulemaking.
anticipated that most reverse
distributors would use the inventory
system to verify the 90-calendar day
time frame rather than taking the extra
step of labeling containers with dates for
verification. EPA also proposed to allow
a reverse distributor to request from
EPA an extension of the 90-day
accumulation time limit for situations
when the hazardous waste
pharmaceuticals are involved in
litigation, a recall, or in unforeseen
circumstances beyond the control of the
reverse distributor. Under the part 262
generator regulations, the extension of
time typically allowed is limited to an
extra 30 days for LQGs. However, due
to the complex nature of pharmaceutical
litigation and recalls, EPA proposed to
allow the EPA Regional Administrator
to grant a time extension at their
discretion on a case-by-case basis.
Summary of Comments. The most
frequent comment EPA received on the
proposed on-site accumulation time
limit was that the 90-day accumulation
limit was too short. Waste Management
National Services, Inc. did not support
the 90-day accumulation limit, arguing
that there are many reasons why a
reverse distributor would experience
significant changes in the volumes of
returns it receives, including recalls.
397
Inmar, Inc. did not support the 90-day
accumulation limit, arguing that its
facilities receive thousands of
shipments every day and it would be
impractical to ensure a 90-day
accumulation limit.
398
Healthcare
Distribution Management Association
pointed out that the 90-day
accumulation limit is too short because
manufacturers frequently take longer
than 90 days to make credit
determinations.
399
Waste Management
National Services, Inc., Qualanex, LLC,
and PharmaLink, Inc. requested that
EPA not require the 90-day
accumulation to begin until the
potentially creditable hazardous waste
pharmaceuticals become evaluated
hazardous waste pharmaceuticals.
400
Stericycle, Inc. requested that EPA
extend the accumulation time limit from
90 days to 180 days and suggested that
there should not be an accumulation
time limit for hazardous waste
pharmaceuticals being held due to
recall.
401
GENCO and Healthcare Waste
Institute of the National Waste and
Recycling Association also requested
that EPA extend the accumulation time
limit from 90 days to 180 days.
402
RILA
Association requested that EPA extend
the accumulation time limit from 90
days to one year.
403
National
Pharmaceutical Returns requested that
EPA place no accumulation time limit
on potentially creditable hazardous
waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals.
404
EPA received multiple comments
suggesting that the accumulation time
limits did not accommodate situations
where reverse distributors receive
unexpired pharmaceuticals that are
otherwise creditable but are awaiting
their expiration date or situations where
reverse distributors ''age'' potentially
creditable pharmaceuticals until they
are eligible for manufacturer credit.
405
One state supported the 90-day
accumulation limit.
406
One state agreed
that the 90-day accumulation limit is
reasonable but did not support allowing
each reverse distributor to have a 90-day
accumulation period because it
increases the potential for
mismanagement.
407
Final Rule Provisions. In response to
comments, EPA is providing additional
time for reverse distributors
accumulating hazardous waste
pharmaceuticals. Specifically, EPA is
finalizing in §
266.510(a)(5) that reverse
distributors may accumulate potentially
creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals on
site for up to 180 calendar days without
having interim status or a permit as long
as they meet the conditions of this
subpart. The Agency is finalizing that
the 180-day time limit begins once the
reverse distributor evaluates the
potentially creditable hazardous waste
pharmaceutical and determines if the
potentially creditable hazardous waste
pharmaceuticals must be transported to
another reverse distributor for further
evaluation of manufacturer credit or if it
will be sent off site for treatment and
disposal. As mentioned in the previous
section, reverse distributors are required
to inventory and evaluate potentially
creditable hazardous waste
pharmaceuticals within 30 calendar
days of arriving at the reverse
distributor. Therefore, the potentially
creditable hazardous waste
pharmaceuticals can be accumulated at
each reverse distributor for no more
than 210 days in total after arrival.
The Agency is finalizing that there is
a 180-day accumulation limit for the
hazardous waste pharmaceutical at each
reverse distributor. Some potentially
creditable hazardous waste
pharmaceuticals travel through more
than one reverse distributor to receive
manufacturer credit. Under the final
rule, each reverse distributor that
receives the potentially creditable
hazardous waste pharmaceuticals has a
new 180-day accumulation limit. Under
the final rule, the 180-day time limit
begins when the reverse distributor
evaluates potentially creditable
hazardous waste pharmaceuticals and to
determine which potentially creditable
hazardous waste pharmaceuticals must
be transported to another reverse
distributor and which ones will be sent
off site for treatment and disposal.
Under the final rule, EPA is not
requiring a specific method that reverse
distributors must use to document that
accumulation does not exceed 180
calendar days. EPA anticipates that
most reverse distributors will use the
inventory system to verify the 180-
calendar day time frame rather than
taking an addition step of labeling
containers with dates for verification.
As discussed previously, EPA is
finalizing that a reverse distributor must
inventory potentially creditable
hazardous waste pharmaceuticals
within 30 calendar days of arriving at
the reverse distributor. Many reverse
distributors utilize barcoding and
scanners to log potentially creditable
pharmaceuticals into a database upon
arrival or soon after a shipment arrives.
Because of the value of the potentially
creditable hazardous waste
pharmaceuticals, and the low risk these
materials present, the Agency is not
requiring specific container
management standards in the final rule.
Furthermore, potentially creditable
hazardous waste pharmaceuticals are
typically still in the manufacturer's
packaging, which would meet our
typical requirement for closed
containers.
Under the final rule, EPA has
eliminated the proposed provision
allowing reverse distributors to request
an extension of the accumulation time
limit. In order to accommodate
situations where hazardous waste
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408
''Pharmacies Besieged by Addicted Thieves''
by Abby Goodnough Published: February 6, 2011
http://www.nytimes.com/2011/02/07/us/
07pharmacies.html.
409
See comment numbers EPA-HQ-RCRA-2007-
0932-0377 and EPA-HQ-RCRA-2007-0932-0295
in the docket for this rulemaking.
410
See comment numbers EPA-HQ-RCRA-2007-
0932-0257, EPA-HQ-RCRA-2007-0932-0280, and
EPA-HQ-RCRA-2007-0932-0315 in the docket for
this rulemaking.
pharmaceuticals are involved in
unforeseen circumstances beyond the
control of the reverse distributor, the
Agency increased the accumulation
time limit from 90 days to 180 days. As
discussed previously, the Agency also
increased the amount of time reverse
distributors can take to evaluate
potentially creditable hazardous waste
pharmaceuticals from 21 to 30 days.
Additionally, in order to accommodate
situations when hazardous waste
pharmaceuticals are involved in
litigation or a recall, under the final
rule, the Agency decided that hazardous
waste pharmaceuticals that are either
involved in an investigation or judicial
proceeding or are subject to a voluntary
or federally-mandated recall are not
required to be managed under subpart P
(see section IX for a detailed
discussion). As a result, we do not
anticipate the need for reverse
distributors to seek accumulation time
extensions and therefore we have
deleted proposed §
266.510(a)(5).
In order to accommodate situations
when reverse distributors receive
unexpired pharmaceuticals that are
otherwise creditable but are awaiting
their expiration date (i.e., aging in a
holding morgue), EPA has added a
provision in §
266.510(a)(5)(ii) to allow
reverse distributors to accumulate these
unexpired pharmaceuticals for up to
180 days after the expiration date
provided that the unexpired
pharmaceuticals are managed in
accordance with the container labeling
and management standards for
evaluated hazardous waste
pharmaceuticals found at
§
266.510(c)(4)(i)-(vi) while they are
aging. This includes labeling containers
with the words ''hazardous waste
pharmaceuticals;'' ensuring the
containers are in good condition,
managed to prevent leaks and
compatible with the contents; and
keeping containers closed.
Once a reverse distributor evaluates a
hazardous waste pharmaceutical and
determines that it is not destined for
another reverse distributor, the reverse
distributor must manage that hazardous
waste pharmaceutical according to the
standards for evaluated hazardous waste
pharmaceuticals (unless, as previously
mentioned, the hazardous waste
pharmaceuticals are unexpired
pharmaceuticals that are otherwise
creditable but are awaiting their
expiration date). The evaluated
hazardous waste pharmaceuticals can be
accumulated for up to 180 calendar days
without having interim status or permits
and they must be managed in
accordance with the standards for
evaluated hazardous waste
pharmaceuticals in §
266.510(c).
Although reverse distributors must
manage the hazardous waste
pharmaceuticals that are not destined
for another reverse distributor in
accordance with the standards for
evaluated hazardous waste
pharmaceuticals, the reverse distributor
can decide at any point during the
accumulation time that the evaluated
hazardous waste pharmaceuticals have
become eligible for manufacturer credit.
If the evaluated hazardous waste
pharmaceuticals become eligible for
manufacturer credit, the reverse
distributor does not get additional
calendar days beyond the 180-day
accumulation time limit to accumulate
the hazardous waste pharmaceuticals. If
the evaluated hazardous waste
pharmaceutical becomes eligible for
manufacturer credit, and the hazardous
waste pharmaceutical will still not be
sent to another reverse distributor for
further evaluation, the reverse
distributor must continue to manage the
hazardous waste pharmaceutical in
accordance with the standards for
evaluated hazardous waste
pharmaceuticals.
EPA does not anticipate a scenario
where an evaluated hazardous waste
pharmaceutical becomes eligible for
manufacturer credit and the reverse
distributor needs to send the hazardous
waste pharmaceutical to another reverse
distributor for further evaluation. A
reverse distributor is unlikely to utilize
resources to accumulate a
pharmaceutical that another reverse
distributor is required to evaluate due to
contractual arrangements with
pharmaceutical manufacturers.
Although EPA does not anticipate this
scenario, if an evaluated hazardous
waste pharmaceutical becomes eligible
for manufacturer credit and the reverse
distributor determines that it should go
to another reverse distributor to be
further evaluated for manufacturer
credit, the reverse distributor can then
resume managing the hazardous waste
pharmaceutical pursuant to the
standards for potentially creditable
hazardous waste pharmaceuticals that
are going on to another reverse
distributor (§
266.510(b)). However, the
reverse distributor does not get
additional time to accumulate the
hazardous waste pharmaceuticals. That
is, the reverse distributor can only
accumulate the hazardous waste
pharmaceuticals for a total of 180 days
after the initial evaluation process is
complete. Overall, this approach
balances the requests from commenters
to accommodate situations where
reverse anticipate that a manufacturer's
policy might change and that evaluated
hazardous waste pharmaceuticals might
become eligible for manufacturer credit
with EPA's belief that it is necessary to
limit total accumulation time to 180
days.
e. Security
Summary of Proposal. EPA proposed
that reverse distributors must meet a
performance-based security requirement
which is based on the existing interim
status TSDF security requirements
found at §
265.14. Due to increased
thefts of pharmaceuticals from
pharmacies reported in recent years in
major media outlets, EPA was
concerned that reverse distributors
could face such thefts since they
accumulate unused pharmaceuticals.
408
Further, commenters on the 2008
Pharmaceutical Universal Waste
proposal suggested that pharmaceutical
universal waste handlers should meet
the TSDF facility security requirement.
EPA agreed with the commenters that
the requirements in the interim status
TSDF security regulations would be
appropriate to adopt and apply to
reverse distributors to prevent the illicit
use of these pharmaceuticals, thereby
safeguarding human health. EPA's
proposal required that they must
prevent unknowing entry, and minimize
the possibility for the unauthorized
entry into the portion of the facility
where potentially creditable and
evaluated hazardous waste
pharmaceuticals are kept (e.g., a
receiving area and accumulation area).
Summary of Comments. Inmar, Inc.
and RILA did not support the proposed
security requirements and argued that
they are duplicative because protective
security measures are already required
by other state and federal laws.
409
One
state and two industry commenters
expressed support that reverse
distributors must meet a performance-
based security standard.
410
One
industry commenter pointed out that
this requirement should not be an added
burden since reverse distributors should
already have significant security
systems in place and one industry
commenter pointed out that the
requirements are consistent with the
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411
See comment number EPA-HQ-RCRA-2007-
0932-0257 in the docket for this rulemaking.
412
See comment number EPA-HQ-RCRA-2007-
0932-0280 in the docket for this rulemaking.
413
See comment numbers EPA-HQ-RCRA-2007-
0932-0257, EPA-HQ-RCRA-2007-0932-0341, and
EPA-HQ-RCRA-2007-0932-0377 in the docket for
this rulemaking.
414
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
415
See comment number EPA-HQ-RCRA-2007-
0932-0295 in the docket for this rulemaking.
416
See the Regulatory Impact Analysis in the
docket for this rulemaking (EPA-HQ-RCRA-2007-
0932).
417
See comment number EPA-HQ-RCRA-2007-
0932-0235 in the docket for this rulemaking.
way that reverse distributors
operate.
411
412
Final Rule Provisions. EPA is
finalizing in §
266.510(a)(6) that reverse
distributors must meet a performance-
based security requirement which is
based on the existing interim status
TSDF security requirements found at
§
265.14. EPA believes that the
requirements that appear in the interim
status TSDF security regulations are
appropriate to adopt and apply to
reverse distributors to prevent the illicit
use of these pharmaceuticals thereby
safeguarding human health. The
security requirement of §
265.14(a)
requires a facility to ''prevent the
unknowing entry, and minimize the
possibility for the unauthorized entry, of
persons or livestock onto the active
portion of his facility.'' EPA is finalizing
a similar requirement for reverse
distributors: they must prevent
unknowing entry and minimize the
possibility for the unauthorized entry
into the portion of the facility where
potentially creditable and evaluated
hazardous waste pharmaceuticals are
kept (e.g., a receiving area and
accumulation area).
Based on site visits and comments
received on the proposed rulemaking,
EPA recognizes that many reverse
distributors may already meet the
proposed security standard through the
use of key cards that allow only
authorized personnel into specific areas
of the reverse distributor, camera
surveillance systems, and cages for
storing pharmaceuticals. Some reverse
distributors may use fences and signs.
EPA is including several examples of
acceptable security measures in the
regulatory text, but reverse distributors
are not limited to the examples
provided. Further, EPA does not believe
this requirement is duplicative because
we included a provision in the
regulations that if a reverse distributor
already meets the performance-based
security standard by complying with
other regulations, such as DEA's
regulations, then the reverse distributor
would not need to install additional
security. Furthermore, in response to
comments we added a reference to the
State Board of Pharmacy regulations as
a second example of other regulations
that could be used to fulfill the
performance based security
requirement.
f. Contingency Plan and Emergency
Procedures
Summary of Proposal. The Agency
proposed to require that reverse
distributors meet standards that are the
same as those that appear in the federal
LQG regulations for developing a
contingency plan and emergency
procedures at 40 CFR part 265 subpart
D. EPA noted in the proposal that a
reverse distributor should be prepared
to respond to potential emergencies just
like LQGs and TSDFs. Since many
reverse distributors are already LQGs,
they should already have contingency
plans to address the hazards on site. It
may be possible that the reverse
distributors would have to amend their
contingency plans to include the
potentially creditable hazardous waste
pharmaceuticals, which have been
considered products, not hazardous
waste, but the Agency pointed out in the
proposal that such modifications should
not impose much burden.
Summary of Comments. One state and
two industry commenters supported the
requirement that reverse distributors
meet the same contingency planning
standards as LQGs at 40 CFR part 265
subpart D.
413
Inmar, Inc. supported the
proposed contingency plan and
emergency procedures requirements and
pointed out that most of their facilities
are LQGs and already follow these
requirements.
414
RILA argued that the
contingency planning and emergency
procedures requirements should not
apply to reverse distributors that handle
lower volumes of hazardous waste than
an SQG generates because the nature of
the waste does not warrant the more
stringent requirements.
415
Final Rule Provisions. EPA is
finalizing in §
266.510(a)(7) that reverse
distributors meet standards that are the
same as those that appear in the federal
LQG regulations for developing a
contingency plan and emergency
procedures. Since this rule was
proposed, the 2016 Hazardous Waste
Generator Improvements rule has been
finalized and has placed the
contingency plan and emergency
procedures for LQGs in part 262 subpart
M, entitled ''Preparedness, Prevention
and Emergency Procedures for Large
Quantity Generators.'' As a result, this
final rule now references the LQG
standards in part 262 subpart M rather
than the interim status TSDF standards
part 265 subpart D. EPA believes that a
reverse distributor should be prepared
to respond to potential emergencies just
like LQGs and TSDFs. Reverse
distributors that are LQGs should
already have contingency plans to
address the hazards on-site.
Commenters pointed out that reverse
distributors that currently operate as
SQGs will face a burden under this
requirement, but EPA's data shows that
most reverse distributors are already
LQGs.
416
It is possible that the reverse
distributors will have to amend their
contingency plans to include the
potentially creditable hazardous waste
pharmaceuticals, which have been
considered products, not hazardous
waste, but EPA does not believe that
such modifications will impose much
burden.
Comments and Responses. One state
recommended that EPA establish a
similar requirement to 40 CFR 264.31
(failure of a facility owner or operator to
maintain or operate facility to minimize
possibility of fire, explosion or releases
of hazardous waste or hazardous waste
constituents) for reverse distributors.
417
EPA included similar language in the
regulations at §
266.510(c)(4)(v).
g. Closure
Summary of Proposal. Due to the
generally low risk of release to the
environment of the hazardous waste
pharmaceuticals that reverse
distributors will accumulate on site, as
well as the value of the hazardous waste
pharmaceuticals, EPA proposed a
performance-based closure standard for
reverse distributors that incorporated
the federal LQG closure standard found
at §
265.111. Specifically, when a
reverse distributor closes its operations
related to hazardous waste
pharmaceuticals, EPA proposed that it
must control or minimize post-closure
releases of hazardous waste into the
environment. EPA expected that this
would entail removing the containers of
both potentially creditable hazardous
waste pharmaceuticals as well as
evaluated hazardous waste
pharmaceuticals from the facility before
closure.
Summary of Comments. Waste
Management National Services, Inc., the
California Department of Toxic
Substances Control, and the Connecticut
Department of Energy and
Environmental Protection support the
requirement for a performance-based
closure standard that is based on the
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See comment numbers EPA-HQ-RCRA-2007-
0932-0257, EPA-HQ-RCRA-2007-0932-0315, and
EPA-HQ-RCRA-2007-0932-0341 in the docket for
this rulemaking.
419
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
420
See comment numbers EPA-HQ-RCRA-2007-
0932-0257, EPA-HQ-RCRA-2007-0932-0278,
EPA-HQ-RCRA-2007-0932-0296, and EPA-HQ-
RCRA-2007-0932-0352 in the docket for this
rulemaking.
421
See comment numbers EPA-HQ-RCRA-2007-
0932-0257 and EPA-HQ-RCRA-2007-0932-0352
in the docket for this rulemaking.
422
See comment number EPA-HQ-RCRA-2007-
0932-0296 in the docket for this rulemaking.
423
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
424
See comment number EPA-HQ-RCRA-2007-
0932-0295 in the docket for this rulemaking.
425
See comment number EPA-HQ-RCRA-2007-
0932-0257 in the docket for this rulemaking.
426
See comment number EPA-HQ-RCRA-2007-
0932-0310 in the docket for this rulemaking.
427
See comment number EPA-HQ-RCRA-2007-
0932-0259 in the docket for this rulemaking.
federal LQG closure standard.
418
Inmar,
Inc. requested that EPA clarify that the
reverse distributor closure requirement
only apply to the closure of the facility
and not to the closure of accumulation
areas.
419
Final Rule Provisions. Under the final
rule at §
266.510(a)(8), EPA is requiring
a performance-based closure standard
that is based on the federal LQG closure
standard. Since the rule was proposed,
the 2016 Hazardous Waste Generator
Improvements rule has been finalized
and has incorporated the LQG closure
standards into the new LQG regulations
in §
262.17. As a result, this final rule
now references the LQG closure
standard in §§
262.17(a)(8)(ii) and (iii)
rather than incorporating the regulatory
language of §
265.111. The LQG closure
standards are substantially the same as
before. Therefore, when a reverse
distributor closes its operations related
to hazardous waste pharmaceuticals, it
must control or minimize post-closure
releases of hazardous waste constituents
into the environment. This will entail
removing the containers of both
potentially creditable hazardous waste
pharmaceuticals as well as evaluated
hazardous waste pharmaceuticals from
the facility before closure. The closure
standards apply when the reverse
distributor closes its operations related
to hazardous waste pharmaceuticals
rather than when the reverse distributor
closes an accumulation area.
h. Reporting
Summary of Proposal. In some
instances, a shipment arriving at a
reverse distributor may inadvertently
include items that are not potentially
creditable pharmaceuticals. These
shipments can include wastes that are
clearly not eligible to receive credit,
such as patient care waste (e.g., IV bags
and tubing), contaminated personal
protective equipment (PPE), medical
waste, or other inappropriate wastes.
Reverse distributors are not the
appropriate waste management facility
for medical or infectious wastes and
these wastes must be managed and
transported from the healthcare facility
to an appropriate waste disposal facility.
In some cases, these non-creditable
wastes may be hazardous waste. These
non-creditable hazardous wastes are
prohibited from being transported from
a healthcare facility to a reverse
distributor and should have been
manifested from the healthcare facility
to a designated facility, such as a
permitted or interim status TSDF.
EPA proposed that if a shipment
including these unauthorized wastes
arrives at a reverse distributor from a
healthcare facility, the reverse
distributor must submit an
unauthorized waste report to the EPA
Regional Administrator within 15 days.
EPA adapted the existing requirement
for situations when permitted and
interim status TSDFs receive
unmanifested hazardous waste (§
264.76
and §
265.76, respectively) to make it
appropriate for situations when
unauthorized waste arrives at a reverse
distributor. EPA also proposed
additional requirements for when
inappropriate hazardous waste arrives at
a reverse distributor.
First, EPA proposed that the reverse
distributor must send a copy of the
unauthorized waste report to the
healthcare facility that sent the
unauthorized waste. This requirement
was intended to alert the healthcare
facility of its mistake in order to prevent
further shipments of non-creditable
hazardous waste or non-pharmaceutical
hazardous waste.
Second, EPA proposed that the
reverse distributor must manage the
unauthorized waste that it receives in
accordance with all applicable
regulations. Third, the Agency proposed
that the EPA Regional Administrator
may require reverse distributors to
furnish additional reports concerning
the quantities and disposition of
potentially creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals.
Summary of Comments. The most
frequent comment that EPA received on
the proposed reporting requirements is
that 15 days is not enough time to
submit an unauthorized waste report to
the EPA Regional Administrator. Four
commenters argued that 15 days is not
enough time to submit an unauthorized
waste report to the EPA Regional
Administrator.
420
Two industry
commenters pointed out that it may take
up to 30 days for shipments to be
processed.
421
Healthcare Waste Institute
of the National Waste and Recycling
Association suggested that reverse
distributors be required to submit an
unauthorized waste report within 15
days of processing a shipment of
hazardous waste rather than within 15
days of receiving the hazardous
waste.
422
CT DEEP supported the reporting
requirements and wrote that the
requirement might incentivize
healthcare facilities not to ship
unauthorized wastes to reverse
distributors.
423
RILA did not support
the reporting requirements and wrote
that reverse distributors should not be
required to submit an unauthorized
waste report when shipments of non-
creditable hazardous waste
pharmaceuticals arrive at the reverse
distributors because the healthcare
facilities are not capable of evaluating
creditworthiness.
424
Waste Management
National Services, Inc. requested that
EPA only require reverse distributors to
send a copy of the unauthorized waste
report to a specific healthcare facility
three times, arguing that it is not the
reverse distributor's responsibility to
continue this reporting.
425
National
Pharmaceutical Returns pointed out that
reverse distributors receive a large
amount of unauthorized waste
pharmaceuticals that healthcare
facilities think are potentially creditable
and therefore the reporting requirements
will be time consuming.
426
One state
requested the EPA clarify if a reverse
distributor may refuse to take a
shipment.
427
Final Rule Provisions. In response to
comments, EPA is finalizing at
§
266.510(a)(9) that if a shipment from a
healthcare facility arrives at a reverse
distributor that includes hazardous
waste that it is not authorized to receive,
the reverse distributor must submit an
unauthorized waste report to the EPA
Regional Administrator within 45 days
of receiving the hazardous waste rather
than the proposed 15 days. However,
EPA is finalizing, as proposed, the
additional requirements for when
shipments of unauthorized waste arrive
at reverse distributors. First, the reverse
distributor must send a copy of the
unauthorized waste report to the
healthcare facility that sent the
unauthorized waste. Second, the reverse
distributor cannot reject the shipment of
non-creditable hazardous waste and
must manage the unauthorized waste in
accordance with all applicable
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See comment number EPA-HQ-RCRA-2007-
0932-0336 in the docket for this rulemaking.
429
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
430
See comment numbers EPA-HQ-RCRA-2007-
0932-0280, EPA-HQ-RCRA-2007-0932-0296, and
EPA-HQ-RCRA-2007-0932-0257 in the docket for
this rulemaking.
431
See comment number EPA-HQ-RCRA-2007-
0932-0280 in the docket for this rulemaking.
432
See comment number EPA-HQ-RCRA-2007-
0932-0228 in the docket for this rulemaking.
regulations (e.g., part 262 or medical
waste regulations). Healthcare facilities
are not equipped as well as reverse
distributors to manage the hazardous
waste and EPA is concerned that
rejecting shipments of non-creditable
hazardous waste will prolong
mismanagement. Third, the Agency is
finalizing as proposed that the EPA
Regional Administrator may require
reverse distributors to furnish additional
reports concerning the quantities and
disposition of potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals. This provides the
Agency with some flexibility in what
reports may be required.
Comments and Responses. The
Agency believes that commenters
understood this provision to apply more
broadly than we intended. We are aware
that healthcare facilities often do not
know whether a hazardous waste
pharmaceutical will receive
manufacturer credit at the reverse
distributor. EPA did not intend for a
reverse distributor to generate an
unauthorized waste report each time a
hazardous waste does not receive credit.
Rather, a reverse distributor must
generate an unauthorized waste report
when it receives waste that it is not
authorized to receive or manage. EPA
reworded the regulations to include
better examples of unauthorized waste,
which includes, but is not limited to,
non-pharmaceutical hazardous waste
and medical or infectious waste.
In order to prevent exposing
employees to unnecessary risk, EPA
recommends as a best management
practice that reverse distributors keep to
a minimum the sorting of shipments
that contain unauthorized waste since
the shipment may include hazardous
waste, including infectious or
radioactive healthcare waste. As a
result, it is possible that a reverse
distributor that receives a shipment that
includes non-creditable waste may be
unsure whether the shipment includes
hazardous waste. In such cases, EPA
recommends that the reverse distributor
assume the shipment includes
hazardous waste and submit an
unauthorized waste report. Further, we
recommend that reverse distributors
work with their clients to reduce the
occurrence of further inappropriate
shipments.
i. Recordkeeping
Summary of Proposal. EPA proposed
three recordkeeping requirements to
provide transparency for the movement
of potentially creditable hazardous
waste pharmaceuticals and as a means
of verification upon inspection. First,
EPA proposed that a reverse distributor
must keep a copy of its notification
(EPA Form 8700-12) to EPA to indicate
that it is a reverse distributor operating
under 40 CFR part 266 subpart P. EPA
proposed that a reverse distributor must
keep the record of notification for as
long as it is subject to these
requirements. Second, EPA proposed
that a reverse distributor must keep
copies of the records associated with
shipments of potentially creditable
hazardous waste pharmaceuticals that it
receives. This included a copy of the
proposed advance notification from the
healthcare facility or other reverse
distributor, a copy of delivery
confirmation, shipping papers or bills of
loading, and any unauthorized waste
reports. The Agency proposed that these
shipping records must be kept for three
years from the date the reverse
distributor receives the shipment. Third,
EPA proposed that a reverse distributor
must keep a copy of its inventory at all
times as long as the reverse distributor
remains subject to this subpart. Finally,
EPA proposed that periods of record
retention indicated previously for a
reverse distributor will be automatically
extended during an enforcement action,
or as requested by the EPA Regional
Administrator to ensure that the
appropriate records are available and
can be reviewed as part of any
enforcement action.
Summary of Comments. EPA received
multiple comments on the
recordkeeping requirements. GENCO
did not support the recordkeeping
requirements, arguing the requirements
would impose burden.
428
Inmar, Inc.
argued that reverse distributors are
already required to keep records under
other regulatory requirements related to
receipt, storage, duration, and shipping
of controlled and uncontrolled
substances.
429
Stericycle, Inc., the Healthcare Waste
Institute of the National Waste and
Recycling Association, and Waste
Management National Services, Inc.
expressed concern about the
requirement that a reverse distributor
must keep a copy of its inventory for as
long as the facility is subject to this
subpart.
430
Stericycle, Inc. argued that it
is not reasonable to require the
inventory be maintained for the life of
the facility.
431
The Illinois Council of
Health-System Pharmacists requested
that EPA clarify whether reverse
distributors must maintain only a
current inventory or that all inventories
as they change must be maintained.
432
Final Rule Provisions. EPA is
finalizing the proposed recordkeeping
requirements at §
266.510(a)(10) with
some minor changes in order to provide
transparency for the movement of
potentially creditable hazardous waste
pharmaceuticals and as a means of
verification upon inspection. First, EPA
is finalizing that a reverse distributor
must keep a copy of its notification
(EPA Form 8700-12) to EPA to indicate
that it is a reverse distributor operating
under 40 CFR part 266 subpart P. A
reverse distributor must keep the record
of notification for as long as it is subject
to these requirements.
Second, EPA is finalizing that a
reverse distributor must keep copies of
the records associated with shipments
of potentially creditable hazardous
waste pharmaceuticals that it receives.
This includes a copy of delivery
confirmation, shipping papers or bills of
lading, and any unauthorized waste
reports. We have revised the regulation
language such that these shipping
records must be kept for three years
from the date the shipment arrives at the
reverse distributor rather than when the
reverse distributor ''receives'' the
shipment since this standard is more
precise.
Third, EPA is finalizing that a reverse
distributor must keep a copy of its
current inventory at all times as long as
the reverse distributor remains subject
to this subpart. The inventory is a living
document that will constantly be
updated and must be available for
inspection. In order to clarify that a
reverse distributor must maintain only a
current inventory rather than all
inventories even if they have changed,
EPA revised the final regulatory
language in §
266.510(a)(2) such that a
reverse distributor must keep a copy of
its current inventory. This
recordkeeping change is being made to
be consistent with that change in
§
266.510(a)(2).
Finally, EPA is finalizing that periods
of record retention referred to in this
section are automatically extended
during an enforcement action, or as
requested by the EPA Regional
Administrator to ensure that the
appropriate records are available and
can be reviewed as part of any
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A healthcare facility or reverse distributor also
has the option of sending its hazardous waste
pharmaceuticals to a RCRA-permitted or interim
status TSDF.
434
Although the proposal did allow for the
possibility to request an accumulation time limit,
the final rule does not.
435
See comment number EPA-HQ-RCRA-2007-
0932-0261 in the docket for this rulemaking.
436
See comment numbers EPA-HQ-RCRA-2007-
0932-0349 and EPA-HQ-RCRA-2007-0932-0377
in the docket for this rulemaking.
437
See comment number EPA-HQ-RCRA-2007-
0932-0349 in the docket for this rulemaking.
438
A healthcare facility or reverse distributor also
has the option of sending its hazardous waste
pharmaceuticals to a RCRA-permitted or interim
status TSDF.
439
See comment number EPA-HQ-RCRA-2007-
0932-0349 in the docket for this rulemaking.
enforcement action. The Agency
recommends reverse distributors keep
electronic versions of these records
rather than paper or hard copy versions
of these records.
Note that additional recordkeeping
requirements may also pertain to reverse
distributors. For example, a reverse
distributor that manifests its non-
pharmaceutical hazardous waste is
subject to the manifest recordkeeping
requirements of §
262.40. Further, as
discussed in subsequent sections, there
are additional recordkeeping
requirements that apply to reverse
distributors for the management of
potentially creditable hazardous waste
pharmaceuticals destined for another
reverse distributor (§
266.510(b)) and
others that apply to reverse distributors
for the management of evaluated
hazardous waste pharmaceuticals
(§
266.510(c)).
2. Additional Standards for Reverse
Distributors Managing Potentially
Creditable Hazardous Waste
Pharmaceuticals Destined for Another
Reverse Distributor (§
266.510(b))
This section discusses the additional
standards that apply to a reverse
distributor for the management of
potentially creditable hazardous waste
pharmaceuticals that require further
evaluation or verification of
manufacturer credit at another reverse
distributor. Since these pharmaceuticals
retain their value and there is greater
incentive to manage them carefully in
order to receive full manufacturer
credit, EPA is requiring few regulatory
standards for the management of the
potentially creditable hazardous waste
pharmaceuticals that are destined for
another reverse distributor.
a. Where potentially creditable
hazardous waste pharmaceuticals can
be sent.
Summary of Proposal. EPA proposed
a limit of three transfers of potentially
creditable hazardous waste
pharmaceuticals before the hazardous
waste pharmaceuticals are ultimately
transported to a permitted or interim
status TSDF. The Agency proposed that
the three possible types of transfers
were:
433
(1) A healthcare facility may send
potentially creditable hazardous waste
pharmaceuticals to a reverse distributor,
which may or may not be a
manufacturer;
(2) the first reverse distributor may
send the potentially creditable
hazardous waste pharmaceuticals to
another reverse distributor, which may
or may not be a manufacturer;
(3) the second reverse distributor can
only send the potentially creditable
hazardous waste pharmaceuticals on to
a reverse distributor that is a
manufacturer.
Because EPA proposed that each
reverse distributor could accumulate
hazardous waste pharmaceuticals up to
90 days after arriving at the reverse
distributor, this proposed chain of
transfers ensured that the potentially
creditable hazardous waste
pharmaceuticals would be accumulated
for no more than 270 days in total after
leaving a healthcare facility and before
being transported to a RCRA-permitted
or interim status TSDF for treatment and
disposal.
434
As described previously,
this is consistent with current practice
among reverse distributors because of
the contractual arrangements that
reverse distributors have with specific
manufacturers.
Summary of Comments. One state did
not support allowing three transfers of
potentially creditable hazardous waste
pharmaceuticals before the hazardous
waste pharmaceuticals are required to
be transported to a TSDF and requested
that EPA consider a maximum of two
transfers prior to transportation to a
TSDF.
435
Two industry commenters
opposed EPA's proposed limit on the
number of times a potentially creditable
hazardous waste pharmaceutical may be
transferred before it must be transported
to a TSDF.
436
One of the industry
commenters argued that reverse
distributors have no knowledge about
the pedigree of products prior to receipt
and as such cannot be held accountable
as to how many times a product is
handled before transport to a TSDF.
437
Final Rule Provisions. The final
regulations for reverse distributors
continue to be structured so that there
is a limit to the number of transfers of
potentially creditable hazardous waste
pharmaceuticals that may occur before
they are ultimately transported to a
TSDF for treatment and disposal.
Stakeholders expressed concern that the
2008 Pharmaceutical Universal Waste
proposal would have allowed hazardous
waste pharmaceuticals to be shipped
repeatedly and indefinitely from one
universal waste handler to another.
From discussions with reverse
distributors and reviewing comments
received on the proposed rulemaking,
the Agency believes a reasonable limit
is three transfers of potentially
creditable hazardous waste
pharmaceuticals before the hazardous
waste pharmaceutical is ultimately
transported to a TSDF. The three
possible types of transfers are:
438
(1) A healthcare facility may send
potentially creditable hazardous waste
pharmaceuticals to a reverse distributor,
which may or may not be a
manufacturer;
(2) the first reverse distributor may
send the potentially creditable
hazardous waste pharmaceuticals to
another reverse distributor, which may
or may not be a manufacturer
(§
266.510(b)(1)); and
(3) the second reverse distributor can
only send the potentially creditable
hazardous waste pharmaceuticals on to
a reverse distributor that is a
manufacturer (§
266.510(b)(2)).
Therefore, if a reverse distributor
receives potentially creditable
hazardous waste pharmaceuticals from a
healthcare facility, the reverse
distributor must send those potentially
creditable hazardous waste
pharmaceuticals to another reverse
distributor (which may or may not be a
manufacturer) or must manage them as
evaluated hazardous waste
pharmaceuticals under §
266.510(c).
However, a reverse distributor that
receives potentially creditable
hazardous waste pharmaceuticals from
another reverse distributor is more
limited in where it can send the
potentially creditable hazardous waste
pharmaceuticals. It can send potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor
that is the manufacturer or else must
manage them as evaluated hazardous
waste pharmaceuticals under
§
266.510(c).
The Agency disagrees with the
commenter who argued that reverse
distributors cannot be accountable for
how many times a hazardous waste
pharmaceutical is transferred because
reverse distributors do not have a record
of transfers of the potentially creditable
hazardous waste pharmaceuticals prior
to receipt.
439
It is not necessary for a
reverse distributor to have a record of
previous transfers. It is only necessary
for a reverse distributor to know
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See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
whether a shipment of potentially
creditable hazardous waste
pharmaceuticals originated from a
healthcare facility or another reverse
distributor. EPA believes it is reasonable
for a reverse distributor to know the
origin of a shipment that arrives at their
facility.
Regardless of the origin or the
destination of the potentially creditable
hazardous waste pharmaceuticals, each
reverse distributor must make an
evaluation of them within 30 calendar
days and may only accumulate the
hazardous waste pharmaceuticals on
site for no more than 180 calendar days
after the evaluation before it ships them
off-site to another reverse distributor or
a RCRA-permitted or interim status
TSDF (resulting in a maximum of 210
days). The 180 calendar day
accumulation time starts after the 30
calendar days to make an evaluation. In
the proposal, reverse distributors only
had 90 days to accumulate hazardous
waste pharmaceuticals on-site,
including the 21 calendar days to make
an evaluation. EPA made this
conforming change to align with the
change in §
266.510(a)(5) that allows
reverse distributors to accumulate
hazardous waste pharmaceuticals on-
site for up to 180 calendar days without
having interim status or a permit. In
addition, all shipments of evaluated
hazardous waste pharmaceuticals are
subject to §
266.508 and shipments of all
potentially creditable hazardous waste
pharmaceuticals are subject to
§
266.509.
Although this chain of transfers will
allow potentially creditable hazardous
waste pharmaceuticals to be
accumulated for up to 630 days in total
after leaving a healthcare facility and
before being transported to a RCRA-
permitted or interim status TSDF for
treatment and disposal, EPA does not
expect that potentially creditable
hazardous waste pharmaceuticals will
be accumulated for this time period in
practice. First, it is unlikely that a
reverse distributor will expend
resources to accumulate potentially
creditable hazardous waste
pharmaceuticals on site for the full 180
calendar days if the potentially
creditable hazardous waste
pharmaceuticals are destined for
another reverse distributor. Second, the
desire to receive manufacturer credit in
a timely manner will also make it
unlikely that reverse distributors will
accumulate potentially creditable
hazardous waste pharmaceuticals for
the full 180 days.
EPA anticipated that some healthcare
facilities that are VSQGs will send their
potentially creditable hazardous waste
pharmaceuticals directly to reverse
distributors. We allow for this under
§
266.504(a). On the other hand,
healthcare facilities that are VSQGs may
choose to consolidate all their
hazardous waste pharmaceuticals (both
creditable and non-creditable) at an off
site healthcare facility, as allowed by
§
266.504(b). In this later case, the
consolidated potentially creditable
hazardous waste pharmaceuticals at an
off-site VSQG in §
266.504(b) are not
counted as one of the 3 allowable
transfers of potentially creditable
hazardous waste pharmaceuticals under
§
266.510(b).
Under the final rule, manufacturers
cannot send hazardous waste
pharmaceuticals to a reverse distributor
because the hazardous waste
pharmaceuticals are no longer
considered potentially creditable
hazardous waste pharmaceuticals. Since
manufacturers are unable to issue credit
to themselves, it is not possible for the
hazardous waste pharmaceuticals to be
considered potentially creditable
hazardous waste pharmaceuticals.
b. Recordkeeping for reverse
distributors shipping potentially
creditable hazardous waste
pharmaceuticals to another reverse
distributor.
Summary of Proposal. EPA proposed
that reverse distributors must keep
records (paper or electronic) for each
shipment of potentially creditable
hazardous waste pharmaceuticals that it
initiates to another reverse distributor
(whether it is a manufacturer or not).
This included a copy of the advance
notification provided to the other
reverse distributor, a copy of delivery
confirmation, as well as shipping papers
or bill of lading. EPA proposed that the
reverse distributor must keep these
shipping records for three years from
the date it initiates the shipment.
Summary of Comments. EPA received
few comments on the recordkeeping
requirements for reverse distributors
that ship potentially creditable
hazardous waste pharmaceuticals to
another reverse distributor. One state
asked EPA to clarify what it means by
''shipping papers.''
440
Final Rule Provisions. EPA is
finalizing in §
266.510(b)(4) that reverse
distributors must keep records (paper or
electronic) readily available upon
request by an inspector for each
shipment of potentially creditable
hazardous waste pharmaceuticals that it
initiates to another reverse distributor
(whether it is a manufacturer or not).
This includes a copy of delivery
confirmation, as well as DOT shipping
papers. EPA has clarified in the
regulations that it is the DOT shipping
papers prepared in accordance with 49
CFR part 172 subpart C we are referring
to as ''shipping papers''; EPA is not
adding a requirement for additional
shipping papers. The regulations do not
specifically mention that reverse
distributors keep a copy of a bill of
lading, as this is only one type of
shipping paper that reverse distributors
can use to comply with 49 CFR part 172
subpart C. EPA is finalizing that these
shipping records must be kept for three
years from the date of shipment.
3. Additional Standards for Reverse
Distributors Managing Evaluated
Hazardous Waste Pharmaceuticals
(§
266.510(c))
This section discusses the additional
standards that apply to a reverse
distributor for the management of
evaluated hazardous waste
pharmaceuticals. In general, the term
evaluated hazardous waste
pharmaceuticals refers to hazardous
waste pharmaceuticals that were
potentially creditable hazardous waste
pharmaceuticals but have been
evaluated by a reverse distributor to
establish whether they are eligible for
manufacturer credit and will not be sent
to another reverse distributor for further
evaluation or verification. While
potentially creditable hazardous waste
pharmaceuticals have value in the form
of manufacturer credit, evaluated
hazardous waste pharmaceuticals do
not. Therefore, in order to minimize the
potential for their mismanagement, EPA
believes it is necessary to have
additional standards for the evaluated
hazardous waste pharmaceuticals.
These standards generally resemble the
standards for LQG CAAs.
a. Accumulation area.
Summary of Proposal. EPA proposed
that once a reverse distributor completes
its evaluation of a potentially creditable
hazardous waste pharmaceutical and
the reverse distributor knows that the
hazardous waste pharmaceutical is
destined for treatment and disposal at a
RCRA-permitted or interim status TSDF,
rather than another reverse distributor,
the pharmaceutical is considered an
evaluated hazardous waste
pharmaceutical. EPA proposed that a
reverse distributor must establish an on-
site accumulation area where it will
accumulate these evaluated hazardous
waste pharmaceuticals. An on-site
accumulation area is needed so that the
evaluated hazardous waste
pharmaceuticals are segregated and
clearly distinguished from the
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441
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
442
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
443
See comment number EPA-HQ-RCRA-2007-
0932-0272 in the docket for this rulemaking.
444
See comment numbers EPA-HQ-RCRA-2007-
0932-0280, EPA-HQ-RCRA-2007-0932-0296, and
EPA-HQ-RCRA-2007-0932-0304 in the docket for
this rulemaking.
445
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
446
See comment number EPA-HQ-RCRA-2007-
0932-0377 in the docket for this rulemaking.
447
See the Regulatory Impact Analysis in the
docket for this rulemaking (EPA-HQ-RCRA-2007-
0932).
potentially creditable hazardous waste
pharmaceuticals.
Summary of Comments. One state
supported the requirement for reverse
distributors to establish on-site
accumulation areas for evaluated
hazardous waste pharmaceuticals.
441
Final Rule Provisions. EPA is
finalizing as proposed that a reverse
distributor must establish an on-site
accumulation area where it will
accumulate evaluated hazardous waste
pharmaceuticals in §
266.510(c)(1). An
on-site accumulation area is needed so
that the evaluated hazardous waste
pharmaceuticals are segregated and
clearly distinguished from the
potentially creditable hazardous waste
pharmaceuticals that have fewer
requirements and are destined for
another reverse distributor.
b. Weekly inspections.
Summary of Proposal. EPA proposed
that the accumulation area for evaluated
hazardous waste pharmaceuticals must
be inspected at least weekly to ensure
containers are not leaking and that
diversion of the evaluated hazardous
waste pharmaceuticals is not occurring.
Under the recordkeeping requirements
for reverse distributors, the Agency
proposed that a reverse distributor must
keep a log of the weekly inspections of
the on-site accumulation area and that
the log must be retained for at least
three years from the date of inspection.
The log is necessary to validate the
weekly inspections.
Summary of Comments. One state
commented that weekly inspections are
not sufficient to determine whether or
not diversion of evaluated hazardous
waste pharmaceuticals is occurring and
requested EPA require additional
security provisions.
442
Washington State
Department of Ecology requested that
EPA clarify the intent of ''at least
weekly'' and argued that they interpret
''at least weekly'' to mean once within
every seven days.
443
Final Rule Provisions. In response to
comments, EPA is finalizing that the
accumulation area for evaluated
hazardous waste pharmaceuticals must
be inspected at least once every seven
days to ensure containers are not
leaking and that diversion of the
hazardous waste pharmaceuticals is not
occurring. We agree with the commenter
that phrasing the standard as ''at least
once every seven days'' is more precise
than ''at least weekly'' and will avoid
the situation where a reverse distributor
could inspect early in one week and late
the following week and still claim it is
inspecting weekly. Under the
recordkeeping requirements for reverse
distributors in §
266.510(c)(10), the
Agency is finalizing that a reverse
distributor must keep a log of the
weekly inspections of the on-site
accumulation area and that the log must
be retained for at least three years from
the date of inspection. The log is
necessary to validate the weekly
inspections.
c. Personnel training.
Summary of Proposal. EPA proposed
to require that reverse distributors meet
the same federal classroom or on-the-job
personnel training regulations that
LQGs must meet (§
265.16). However,
the Agency specified in the proposal
that the personnel that need to be
trained are those persons who handle
the evaluated hazardous waste
pharmaceuticals in the on-site
accumulation area. EPA argues that
these personnel are the individuals
handling and managing the evaluated
hazardous waste pharmaceuticals and
must have appropriate hazardous waste
training.
Summary of Comments. Two industry
commenters and one state supported the
personnel training criteria for reverse
distributors.
444
One state argued that the
training requirements should be applied
to the personnel who handle potentially
creditable hazardous waste
pharmaceuticals in addition to the
personnel who handle evaluated
hazardous waste pharmaceuticals on
site.
445
Inmar, Inc. pointed out that
personnel at reverse distributors are
already required to receive training
under other regulatory requirements.
446
Final Rule Provisions. Under the final
rule, reverse distributors must meet the
same classroom or on-the-job personnel
training requirements that LQGs must
meet. EPA is finalizing that the
personnel that need to be trained are
those persons who handle the evaluated
hazardous waste pharmaceuticals. Since
these personnel are the individuals
handling and managing the hazardous
waste pharmaceuticals, they must have
appropriate hazardous waste training.
As mentioned previously, EPA received
multiple comments in support of the
training requirements for reverse
distributors. Additionally, EPA does not
believe the training requirements will
add burden because EPA believes most
reverse distributors currently operate as
LQGs.
447
Since the proposed
rulemaking, the 2016 Hazardous Waste
Generator Improvement rule was
finalized. As part of its reorganization,
the personnel training regulations for
LQGs are now incorporated into
§
262.17(a)(7) and no longer refer to
§
265.16. As a result, the §
266.510(c)(3)
training requirements for personnel
managing evaluated hazardous waste
pharmaceuticals at reverse distributors
now reference §
262.17(a)(7) instead of
§
265.16.
d. Labeling and management of
containers in on-site accumulation area.
Summary of Proposal. EPA proposed
that while containers of evaluated
hazardous waste pharmaceuticals are in
the on-site accumulation area, they must
be marked with the words, ''hazardous
waste pharmaceuticals.'' EPA proposed
this term in order to distinguish them
from the non-hazardous waste
pharmaceuticals and from the
hazardous waste pharmaceuticals that
are still considered potentially
creditable. The Agency did not propose
to require an accumulation start date on
the label for the containers of evaluated
hazardous waste pharmaceuticals.
In terms of container management
standards, the Agency proposed
requirements that are similar to the
container management standards for
LQGs, but the Agency proposed to
include some requirements specific to
evaluated hazardous waste
pharmaceuticals. For example, LQGs
must keep all containers of hazardous
waste closed. However, EPA proposed
to require that only containers with
hazardous waste pharmaceuticals that
are liquids or gels be kept closed during
accumulation due to the low potential
for release to the environment for those
hazardous waste pharmaceuticals that
are in a solid form. The Agency did not
propose to require other containers of
evaluated hazardous waste
pharmaceuticals to be closed during
accumulation, although we expect that
reverse distributors would choose to do
so as a best management practice.
Further, because most evaluated
hazardous waste pharmaceuticals are in
their original packaging, we proposed
that if the original packaging for gels or
liquids is intact and sealed or the
pharmaceuticals have been repackaged
(e.g., for unit dosing) and the
repackaged packaging for gels and
liquids is intact and sealed, they are
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448
See comment numbers EPA-HQ-RCRA-2007-
0932-0211, EPA-HQ-RCRA-2007-0932-0235,
EPA-HQ-RCRA-2007-0932-0341, and EPA-HQ-
RCRA-2007-0932-0257 in the docket for this
rulemaking.
449
See comment number EPA-HQ-RCRA-2007-
0932-0280 in the docket for this rulemaking.
450
See comment number EPA-HQ-RCRA-2007-
0932-0333 in the docket for this rulemaking.
451
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
452
See comment number EPA-HQ-RCRA-2007-
0932-0296 in the docket for this rulemaking.
considered to meet the proposed closed
container standard.
As with LQGs, EPA proposed that
containers of evaluated hazardous waste
pharmaceuticals must be maintained in
good condition to prevent leaks and the
container material must be compatible
with the evaluated hazardous waste
pharmaceuticals placed in the
container. Another requirement that was
tailored to reverse distributors was the
proposal that reverse distributors that
accumulate evaluated hazardous waste
pharmaceuticals must segregate the
pharmaceuticals that are prohibited
from being combusted because of the
dilution prohibition of §
268.3(c) and
accumulate them in separate containers
from other evaluated hazardous waste
pharmaceuticals.
The LQG regulations in part 262
include management standards for
several types of accumulation units that
EPA did not propose to include for the
management of evaluated hazardous
waste pharmaceuticals. For instance, the
proposal only set standards for the
accumulation of evaluated hazardous
waste pharmaceuticals in containers.
EPA did not think it was necessary to
include standards for accumulation
units such as tanks, containment
buildings, or drip pads because reverse
distributors do not currently use these
types of accumulation units. In
addition, the Agency did not propose to
require reverse distributors to meet the
air emission standards found in 40 CFR
part 265 subpart CC as required in
§
262.34(a)(1)(i) for LQGs because the
Agency anticipated that they will not be
applicable. Additionally, 40 CFR part
265 subpart AA-air emissions
standards for process vents-and
subpart BB-air emission standards for
equipment leaks-are not applicable to
the activities of a reverse distributor.
Summary of Comments. EPA received
numerous comments on the proposed
requirements for labeling and
management of containers of evaluated
hazardous waste pharmaceuticals in on-
site accumulation areas at reverse
distributors. One state supported that
containers be marked with the words
''hazardous waste pharmaceuticals,'' but
three states and one industry
commenter requested that EPA require
reverse distributors to label containers
with the accumulation start date.
448
Stericycle, Inc. agreed that there is not
a need to include standards for
accumulation units such as tanks,
containment buildings, or drip pads.
449
Clean Harbors argued that the only way
to prevent diversion of hazardous waste
pharmaceuticals is for all containers to
be closed and sealed.
450
One state
requested that EPA prohibit reverse
distributors from mixing or
commingling incompatible hazardous
waste pharmaceuticals in the same
container rather than only requiring
reverse distributors to manage
containers to prevent dangerous
situations, such as fire explosion or
release of toxic fumes.
451
One
commenter agreed that the 40 CFR part
265 subpart AA-air emissions
standards for process vents-and
subpart BB-air emission standards for
equipment leaks-are not applicable to
the activities of a reverse distributor and
its management of hazardous waste
pharmaceuticals.
452
Final Rule Provisions. Final standards
for labeling and management of
containers at an on-site accumulation
area are found at §
266.510(c)(4). EPA is
finalizing that while containers of
evaluated hazardous waste
pharmaceuticals are in the
accumulation area, they must be marked
with the words, ''hazardous waste
pharmaceuticals.'' Under the final rule,
reverse distributors are not required to
mark an accumulation start date on the
label for the containers, because the
reverse distributor's inventory will
likely be used to verify the
accumulation start date. However, a
reverse distributor may choose an
alternate method, such as marking the
date on each container, to ensure that
the containers of evaluated hazardous
waste pharmaceuticals are not
accumulated at the reverse distributor
for more than 180 days. As explained
previously, EPA prefers to allow a
performance-based standard that allows
flexibility to verify the 180-day
accumulation time rather than require
dating on the container labels. Most of
the commenters that requested
accumulation start dates on labels were
states. Although the requirement is not
being finalized at the federal level, any
authorized state has the ability to
impose more stringent regulations. If a
state chooses to require the
accumulation start date on the container
label, that would be considered more
stringent and permissible under RCRA.
In terms of container management
standards, the Agency is finalizing the
proposed requirements that are similar
to the container management standards
for LQGs as well as the additional
management requirements specific to
evaluated hazardous waste
pharmaceuticals. Specifically, only
containers with evaluated hazardous
waste pharmaceuticals that are liquids
or gels must be kept closed during
accumulation, although EPA expects
that all containers of evaluated
hazardous waste pharmaceuticals will
be closed given that evaluated
hazardous waste pharmaceuticals are in
their original packaging. As with the
proposal, if the original packaging for
gels or liquids is intact and sealed or the
pharmaceuticals have been repackaged
(e.g., for unit dosing) and the
repackaged packaging for gels and
liquids is intact and sealed, they are
considered to meet the closed container
standard.
EPA is also finalizing that containers
of evaluated hazardous waste
pharmaceuticals must be maintained in
good condition to prevent leaks and the
container material must be compatible
with the hazardous waste
pharmaceuticals placed in the
container. In addition, a reverse
distributor that manages any container
of ignitable or reactive evaluated
hazardous waste pharmaceuticals or any
container of commingled incompatible
evaluated hazardous waste
pharmaceuticals must manage the
container to prevent dangerous
situations, such as fire, explosion, or
release of toxic fumes. These regulations
are consistent with the LQG container
management regulations in part 262 and
already apply to LQG reverse
distributors accumulating hazardous
waste on site. The Agency is also
finalizing that reverse distributors that
accumulate evaluated hazardous waste
pharmaceuticals must segregate the
pharmaceuticals that are prohibited
from being combusted because of the
dilution prohibition of §
268.3(c) and
accumulate them in separate containers
from other evaluated hazardous waste
pharmaceuticals. The dilution
prohibition of §
268.3(c) already
prohibits the incineration of some
hazardous waste pharmaceuticals. This
new provision highlights this
prohibition to the reverse distributors
accumulating the hazardous waste
pharmaceuticals prior to sending off site
for treatment and disposal.
Comments and Responses. EPA is
finalizing management standards only
for containers used to accumulate
evaluated hazardous waste
pharmaceuticals because commenters
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453
See comment numbers EPA-HQ-RCRA-2007-
0932-0300 and EPA-HQ-RCRA-2007-0932-0341
in the docket for this rulemaking.
454
See comment number EPA-HQ-RCRA-2007-
0932-0257 in the docket for this rulemaking.
455
See comment numbers EPA-HQ-RCRA-2007-
0932-0261 and EPA-HQ-RCRA-2007-0932-0341
in the docket for this rulemaking.
456
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
confirmed that reverse distributors do
not use other types of hazardous waste
accumulation units, such as tanks,
containment buildings, or drip pads.
In addition, the Agency is not
requiring reverse distributors to meet
the air emission standards found in 40
CFR part 265 subpart CC as required for
LQGs in §
262.17(a)(1)(i) because the
Agency anticipates that they will not be
applicable. Specifically, §
265.1083(c) of
subpart CC exempts tanks, surface
impoundments, and containers from the
organic air emission standards if the
hazardous waste entering the
accumulation unit has an average
volatile organic concentration of less
than 500 parts per million by weight,
while §
265.1080(b)(2) of subpart CC
exempts containers with a capacity of
less than 0.1 m
3
(26 gallons) from the
standards. EPA understands that the
only evaluated hazardous waste
pharmaceuticals that have the potential
for air emissions are liquids and gels,
but they generally do not contain
volatile organics. Thus, they do not
release organic air emissions, which is
what the 40 CFR part 265 subpart CC air
emission standards for tanks, surface
impoundments, and containers were
promulgated to control. Moreover,
because evaluated hazardous waste
pharmaceuticals are often in their
original packaging, and EPA is requiring
that liquid and gel evaluated hazardous
waste pharmaceuticals must be in
intact, sealed packaging or otherwise in
closed containers, EPA believes that the
container air emission standards are
unnecessary. In addition, the Agency
anticipates that the packaging and
containers for hazardous waste
pharmaceuticals will have a capacity of
less than 0.1 m
3
(26 gallons) further
limiting the applicability of the
container air emission standards.
Similarly, EPA does not anticipate that
the 40 CFR part 265 subpart AA (air
emissions standards for process vents)
and subpart BB (air emission standards
for equipment leaks) are applicable to
the activities of a reverse distributor and
its management of evaluated hazardous
waste pharmaceuticals. Therefore, like
40 CFR part 265 subpart CC discussed
previously, EPA is not requiring that 40
CFR part 265 subparts AA and BB apply
to reverse distributors.
e. Hazardous waste numbers (codes).
Summary of Proposal. EPA proposed
that RCRA hazardous waste numbers
(commonly called ''hazardous waste
codes'') must be marked on the
container label in order to ensure that
they are readily visible and cannot be
separated from the hazardous waste. In
the proposal, the Agency did not require
that the reverse distributor be the party
that adds the hazardous waste codes to
the containers. The proposed
regulations allowed a vendor to perform
this duty on behalf of the reverse
distributor.
Summary of Comments. Two states
supported the requirement that
hazardous waste codes be placed on
containers of evaluated hazardous waste
pharmaceuticals.
453
Waste Management
National Services, Inc. argued that it is
not practical to include all hazardous
waste codes on each container label and
instead suggested that codes be listed on
the hazardous waste profile developed
with the TSDF and on the manifest.
454
Final Rule Provisions. Under the final
rule, EPA is requiring that the
containers of evaluated hazardous waste
pharmaceuticals be marked with the
applicable RCRA hazardous waste
numbers (codes) at §
266.510(c)(5). The
hazardous waste codes must be added
prior to shipping evaluated hazardous
waste pharmaceuticals off site, although
they may be placed on the container
label at any time during on-site
accumulation. The hazardous waste
numbers must be marked on the
container label in order to ensure that it
is readily visible and cannot be
separated from the hazardous waste. It
is necessary that the hazardous waste
numbers are on the containers so that
transporters, transfer facilities, and
TSDFs know how to properly transport,
consolidate, treat, store and dispose of
the hazardous waste in compliance with
the applicable RCRA regulations. In the
final rule, the Agency is not requiring
that the reverse distributor be the party
that adds the hazardous waste numbers
to the containers. The regulations allow
a vendor to perform this duty on behalf
of the reverse distributor. In practice,
however, if a vendor is responsible for
assigning hazardous waste numbers,
personnel from the reverse distributor
may need to assist in the process. To be
consistent with the Hazardous Waste
Generator Improvements final rule, we
have added a sentence to §
266.510(c)(5)
indicating that a nationally recognized
electronic system, such as bar coding or
radio frequency identification, may be
used to identify the EPA Hazardous
Waste number(s).
f. Shipping evaluated hazardous
waste pharmaceuticals.
Summary of Proposal. Although it is
already stated in §
266.508(a) under the
section of the regulations that pertains
to shipping standards, for clarity, EPA
proposed to repeat in the §
266.510 the
reverse distributor regulations that
reverse distributors that ship evaluated
hazardous waste pharmaceuticals off
site must do so in accordance with the
proposed shipping requirements in
§
266.508(a). This includes the
applicable DOT packaging, marking and
labeling requirements, as well as the
requirement to utilize the hazardous
waste manifest when shipping the
evaluated hazardous waste to a
designated facility.
Summary of Comments. Two states
generally supported the shipping
requirements for evaluated hazardous
waste pharmaceuticals.
455
One state
supported that EPA repeat in §
266.510
the requirements pertaining to shipping
standards although it is already stated in
§
266.508(a).
456
Final Rule Provisions. For clarity, the
final reverse distributor regulations state
that a reverse distributor must ship
evaluated hazardous waste
pharmaceuticals that are destined for a
permitted or interim status treatment,
storage or disposal facility in
accordance with the applicable shipping
standards in §
266.508(a) or (b). This
includes the applicable DOT packaging,
marking and labeling requirements, as
well as the requirement to utilize the
hazardous waste manifest when
shipping the evaluated hazardous waste
to a permitted or interim status TSDF.
g. Procedures for managing rejected
shipments.
Summary of Proposal. The Agency
proposed to require that reverse
distributors meet the same procedures
that LQGs must meet for rejected
shipments in §
262.42(c). Specifically, if
a designated permitted or interim status
TSDF identified on the hazardous waste
manifest cannot accept a shipment of
evaluated hazardous waste
pharmaceuticals from a reverse
distributor and the TSDF returns the
shipment to the reverse distributor, EPA
proposed that the reverse distributor
must sign either item 18c of the original
manifest or item 20 of a new manifest.
In addition, the proposal allowed the
reverse distributor to consolidate the
rejected hazardous waste
pharmaceuticals on site for up to 90
days provided they were managed in the
on-site accumulation area and in
accordance with the reverse distributor
standards for evaluated hazardous waste
pharmaceuticals. EPA also proposed
that reverse distributors send a copy of
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457
See comment number EPA-HQ-RCRA-2007-
0932-0231 in the docket for this rulemaking.
458
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
459
See comment numbers EPA-HQ-RCRA-2007-
0932-0315 and EPA-HQ-RCRA-2007-0932-0341
in the docket for this rulemaking.
460
See comment number EPA-HQ-RCRA-2007-
0932-0288 in the docket for this rulemaking.
461
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
462
See comment number EPA-HQ-RCRA-2007-
0932-0295 in the docket for this rulemaking.
463
See the Regulatory Impact Analysis in the
docket for this rulemaking EPA-HQ-RCRA-2007-
0932.
the manifest to the designated facility
that returned the shipment to the
reverse distributor within 30 days of
delivery.
Summary of Comments. One state
requested the EPA clarify that a reverse
distributor that receives a rejected
shipment does not have to transport it
off site upon receipt by the reverse
distributor.
457
One state argued that a
reverse distributor does not need 90
days to accumulate rejected hazardous
waste pharmaceuticals in the on-site
accumulation area and argued that 30
days is sufficient.
458
Final Rule Provisions. The Agency is
finalizing in §
266.510(c)(7) that reverse
distributors must meet the same
procedures that LQGs must meet for
rejected shipments in §
262.42(c). Under
part 262, these rejected shipment
procedures already apply to LQG
reverse distributors. Furthermore, EPA
anticipates that a rejected shipment is a
relatively infrequent occurrence and
therefore should not be a burden to
reverse distributors. In addition, the
final rule allows the reverse distributor
to consolidate the rejected hazardous
waste pharmaceuticals on site for up to
90 days provided they are managed in
the on-site accumulation area and in
accordance with the reverse distributor
standards for evaluated hazardous waste
pharmaceuticals. Although one state
requested EPA only allow accumulation
for 30 days, any authorized state has the
ability to impose more stringent
regulations. If a state chooses to shorten
the accumulation time, that would be
considered more stringent and
permissible under RCRA.
h. Land disposal restrictions.
Summary of Proposal. EPA proposed
that reverse distributors are subject to
the same LDRs that apply to LQGs with
respect to their evaluated hazardous
waste pharmaceuticals. In addition, EPA
proposed to amend the testing, tracking,
and recordkeeping requirements for
generators, treaters and disposal
facilities at §
268.7 to add the words,
''pharmaceutical reverse distributors'' to
the title of that section to make the
applicability of the treatment standards
clear.
Summary of Comments. EPA received
multiple comments in support of the
requirement that reverse distributors
meet the same LDRs that apply to LQGs
with respect to their evaluated
hazardous waste pharmaceuticals,
including two states.
459
The Oregon
Association of Clean Water Agencies
wrote that applying the LDRs will
reduce mobility of pharmaceutical
constituents in landfill leachate, which
is frequently routed to POTWs in
Oregon.
460
Final Rule Provisions. As required by
HSWA, EPA is finalizing that reverse
distributors are subject to the same land
disposal restrictions that apply to LQGs
with respect to their evaluated
hazardous waste pharmaceuticals. In
addition, EPA is amending the titles at
§§
268.7 and 268.7(a) to add the words,
''reverse distributors'' to make the
applicability of the land disposal
restrictions clear. SQG and LQG reverse
distributors are already subject to LDRs
for their hazardous waste
pharmaceuticals. Therefore, this
provision does not impose additional
burden on reverse distributors.
i. Reporting.
Summary of Proposal. EPA proposed
that reverse distributors submit a
biennial report (BR) for the evaluated
hazardous waste pharmaceuticals that
are transported to a TSDF in order for
the Agency to have as complete a
picture of the amount of hazardous
waste generated, treated, stored, or
disposed of annually. The Agency
proposed that the BR should only
include the evaluated hazardous waste
pharmaceuticals, and not the potentially
creditable hazardous waste
pharmaceuticals that a reverse
distributor sends to another reverse
distributor. Specifically, EPA proposed
that a reverse distributor comply with
the LQG BR requirements in §
262.41,
except for §
262.41(a)(7), which
included the requirement to report
changes in volume and toxicity of waste
achieved during the year in comparison
to previous years. The Agency did not
propose that a reverse distributor
provide such information because it
does not have control of the volume or
toxicity of the hazardous waste
pharmaceuticals it receives from
healthcare facilities, and thus has no
ability to reduce the volume or toxicity
of the hazardous waste pharmaceuticals.
EPA proposed that reverse
distributors provide an exception report
when a TSDF does not return the
hazardous waste manifest to the reverse
distributor for shipments of evaluated
hazardous waste pharmaceuticals.
Likewise, EPA proposed that reverse
distributors meet LQG exception
reporting when a shipment from a
reverse distributor is rejected by the
designated facility and forwarded onto
an alternate facility. These proposed
standards were adapted from the
exception reporting for LQGs in
§
262.42(a).
Summary of Comments. One state
supported both of the proposed
reporting requirements for reverse
distributors managing evaluated
hazardous waste pharmaceuticals that
are transported to a TSDF.
461
RILA
argued that the requirement that reverse
distributors submit a BR for the
evaluated hazardous waste
pharmaceuticals that are transported to
a TSDF is effectively more stringent
than current generator requirements that
only require generators to submit a
biennial report if they generate over
1000 kg of hazardous waste in a
month.
462
Final Rule Provisions. EPA is
finalizing at §
266.510(c)(9)(i) that
reverse distributors submit a BR for the
evaluated hazardous waste
pharmaceuticals that are transported to
a TSDF in order for the Agency to have
as complete a picture of the amount of
hazardous waste generated, treated,
stored, or disposed of annually. The BR
should only include the evaluated
hazardous waste pharmaceuticals, and
not the potentially creditable hazardous
waste pharmaceuticals that a reverse
distributor sends to another reverse
distributor. EPA does not expect that
requiring reverse distributors to submit
a BR for evaluated hazardous waste
pharmaceuticals will be burdensome
because most reverse distributors
currently operate as LQGs and already
submit a BR.
463
Specifically, under the
final rule, reverse distributors must
comply with the LQG BR requirements
in §
262.41. EPA proposed that reverse
distributors had to comply with the
LQG BR requirements in §
262.41 except
§
262.41(a)(7), which included the
requirement to report changes in
volume and toxicity of waste achieved
during the year in comparison to
previous years. However, since the
proposed rulemaking, the 2016
Hazardous Waste Generator
Improvement rule was finalized. As part
of that final rule, §
262.41(a)(7) was
removed from the generator
requirements. Thus, the final rule only
states that reverse distributors must
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464
See comment number EPA-HQ-RCRA-2007-
0932-0386 in the docket for this rulemaking.
465
See comment number EPA-HQ-RCRA-2007-
0932-0341 in the docket for this rulemaking.
466
See comment number EPA-HQ-RCRA-2007-
0932-0333 in the docket for this rulemaking.
467
See comment number EPA-HQ-RCRA-2007-
0932-0297 in the docket for this rulemaking.
comply with the LQG BR requirements
in §
262.41.
Consistent with the LQG regulations
in part 262, EPA is finalizing at
§
266.510(c)(9)(ii) that reverse
distributors must provide an exception
report when a TSDF does not return the
signed hazardous waste manifest to the
reverse distributor for shipments of
hazardous waste pharmaceuticals to a
designated facility within 45 days of
shipment. Likewise, EPA is finalizing
that reverse distributors must provide
an exception report when a shipment
from a reverse distributor is rejected by
the designated facility and forwarded
onto an alternate facility and the reverse
distributor does not receive a copy of
the manifest with the signature of the
owner or operator of the alternate
facility within 35 days. These standards
were adapted from the exception
reporting for LQGs in §
262.42(a), while
the standards for healthcare facilities
managing non-creditable hazardous
waste pharmaceuticals were adapted
from the exception reporting for SQGs
§
262.42(b). EPA is finalizing that a
reverse distributor that does not receive
a copy of the manifest within 35 days
of the date the evaluated hazardous
waste pharmaceuticals were accepted by
the initial transporter must contact the
transporter or TSDF to determinate the
status of the evaluated hazardous waste
pharmaceuticals. EPA is also finalizing
that a reverse distributor must submit a
copy of an exception report if it has not
received a copy of the manifest within
45 days of the date the evaluated
hazardous waste pharmaceuticals were
accepted by the initial transporter. The
exception report must include a legible
copy of the manifest for which the
reverse distributor does not have
confirmation of delivery and a cover
letter explaining efforts taken to locate
the evaluated hazardous waste
pharmaceuticals.
j. Recordkeeping.
Summary of Proposal. In total, EPA
proposed five recordkeeping
requirements that pertain to evaluated
hazardous waste pharmaceuticals at
reverse distributors. First, EPA proposed
that a reverse distributor keep a log
(written or electronic) of its weekly
inspections of the on-site accumulation
area. The other four recordkeeping
requirements that EPA proposed for
reverse distributors are the same as the
LQG recordkeeping requirements that
appear in §§
262.17(a)(7)(iv) and (v),
262.40, and 262.42; these include
training documentation, hazardous
waste manifest records, records of
biennial reports, and exception
reporting.
Summary of Comments. Hennepin
County supported the requirement for
reverse distributors to document
training.
464
Final Rule Provisions. Many of the
final recordkeeping requirements that
pertain to evaluated hazardous waste
pharmaceuticals have been discussed in
the sections previously, but for clarity,
it is useful to restate them in this
recordkeeping section, so that reverse
distributors can refer to one section to
determine their recordkeeping
requirements related to evaluated
hazardous waste pharmaceuticals. In
total, EPA is finalizing five
recordkeeping requirements that pertain
to evaluated hazardous waste
pharmaceuticals at reverse distributors
that can be found listed at
§
266.510(c)(10). First, EPA is requiring
that a reverse distributor keep a log
(written or electronic) of its inspections
of the on-site accumulation area. The
other four recordkeeping requirements
that EPA is requiring under the final
rule for reverse distributors are the same
as the LQG recordkeeping requirements
in part 262. These include hazardous
waste manifest records, records of
biennial reports, exception reporting
and training documentation.
4. When a Reverse Distributor Must
Have a RCRA Hazardous Waste Permit
(§
266.510(d))
a. Summary of proposal. In the
proposed rulemaking, EPA did not
require that a reverse distributor have a
RCRA permit or interim status for
accumulating potentially creditable and
evaluated hazardous waste
pharmaceuticals, provided that the
reverse distributor follows all the
conditions of the permitting exemption
in §
266.510. However, EPA proposed
that a reverse distributor must have a
RCRA permit (or interim status) if it
treats or disposes of hazardous waste on
site or if it accepts manifested
hazardous waste from off site.
b. Summary of comments. One state
supported the proposed requirement
that a reverse distributor must have a
RCRA permit (or interim status) if it
treats or disposes of hazardous waste on
site or if it accepts manifested
hazardous waste from off site.
465
Clean
Harbors argued that EPA's rationale for
not requiring a hazardous waste storage
permit is flawed and argued that the
requirement for obtaining a full RCRA
permit be based on the amount of time
a potentially creditable hazardous waste
pharmaceutical is stored.
466
The
Environmental Technology Council
argued that reverse distributors should
be required to obtain permits or interim
status for storage.
467
c. Final rule provisions. Under the
final rule, EPA is not requiring that a
reverse distributor have a RCRA permit
or interim status for accumulating
potentially creditable and evaluated
hazardous waste pharmaceuticals,
provided that the reverse distributor
follows all the conditions of the
permitting exemption in §
266.510. In
other words, a reverse distributor will
be subject to regulation as a TSDF and
require a RCRA permit (or interim
status) if it does not meet the conditions
of §
266.510. In addition, EPA is
finalizing that a reverse distributor must
have a RCRA permit (or interim status)
if it treats or disposes of hazardous
waste on site or if it accepts manifested
hazardous waste from off site. A reverse
distributor is required to reject
shipments of manifested hazardous
waste that it may inadvertently receive
from off site because a reverse
distributor is not a designated facility
and therefore is not eligible to receive
hazardous waste shipped with a
manifest. EPA believes that this
approach to regulation of reverse
distributors that accumulate potentially
creditable and evaluated hazardous
waste pharmaceuticals strikes an
appropriate balance because it
recognizes that reverse distributors are
different from typical hazardous waste
TSDFs for permitting purposes, while it
still imposes certain conditions for
exemption from permitting
requirements that provide the necessary
environmental protection.
XVIII. Amendments to the Part 268
Prohibitions on Storage
The Agency is finalizing conforming
changes that we proposed to the
prohibitions on storage of restricted
waste in §
268.50. We are finalizing two
new subparagraphs in §
268.50(a) to
make it clear that the storage
prohibitions apply to both healthcare
facilities and reverse distributors
operating under part 266 subpart P.
Specifically, we are adding paragraph
(4) for healthcare facilities and
paragraph (5) for reverse distributors to
extend the application of the existing
storage prohibition to facilities
operating under subpart P. Under the
LDR storage prohibition the storage of
restricted hazardous wastes is
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prohibited unless certain conditions are
met. Healthcare facilities must comply
with the applicable requirements in
§§
266.502 and 266.503 and reverse
distributors must comply with §
266.510
when accumulating hazardous waste
pharmaceuticals on site.
XIX. Implementation and Enforcement
A. Healthcare Facilities
1. Determining Whether a Healthcare
Facility Is Subject to Part 266 Subpart P
EPA is finalizing that healthcare
facilities that are currently considered
LQGs or SQGs are subject to the final 40
CFR part 266 subpart P requirements for
the management of hazardous waste
pharmaceuticals. Thus, a healthcare
facility that generates more than 100 kg
of hazardous waste per month, or more
than 1 kg of acute hazardous waste per
calendar month, or more than 100 kg of
any residue or contaminated soil, water,
or other debris resulting from the
cleanup of a spill, into or on any land
or water, of any acute wastes listed in
§§
261.31, or 261.33(e), must manage its
hazardous waste pharmaceuticals in
compliance with the 40 CFR part 266
subpart P requirements. In addition,
healthcare facilities that are VSQGs are
subject to the prohibition on sewering
hazardous waste pharmaceuticals in
§
266.505, the empty container
standards in §
266.507, and the optional
standards of §
266.504.
To determine whether a healthcare
facility is subject to 40 CFR part 266
subpart P or is a VSQG regulated under
§
262.14, a healthcare facility must
count all the hazardous waste-
pharmaceutical and non-
pharmaceutical-it generates in a
calendar month. Note that in the final
rule EPA has revised which
pharmaceuticals are considered
hazardous wastes. Specifically, EPA is
finalizing that potentially creditable
hazardous waste pharmaceuticals
transported to a reverse distributor are
considered a solid and hazardous waste
from the point of generation at the
healthcare facility and therefore must be
counted when determining whether the
healthcare facility is a VSQG regulated
under §
262.14 or whether it is regulated
under 40 CFR part 266 subpart P for its
hazardous waste pharmaceuticals. This
differs from previous healthcare facility
practice of not counting the potentially
creditable hazardous waste
pharmaceuticals it sends to a reverse
distributor towards its hazardous waste
generator category. Therefore, although
a healthcare facility may have been
considered a VSQG under that previous
practice, when it begins counting its
potentially creditable hazardous waste
pharmaceuticals, it may no longer be a
VSQG. In that case, the healthcare
facility would be subject to the 40 CFR
part 266 subpart P requirements for its
hazardous waste pharmaceuticals.
2. Healthcare Facilities Managing
Hazardous Waste Pharmaceuticals
Under Part 266 Subpart P
EPA is finalizing that all healthcare
facilities operating Under part 266
subpart P will be subject to the same
regulations for the management of their
hazardous waste pharmaceuticals,
regardless of the quantity of hazardous
waste pharmaceuticals generated. A
healthcare facility that generates both
pharmaceutical and non-pharmaceutical
hazardous waste must manage the non-
pharmaceutical hazardous waste
pursuant to part 262, but need not count
its hazardous waste pharmaceuticals
toward determining the facility's
monthly hazardous waste generator
category. Therefore, although a facility
that previously may have been
considered an LQG, once it no longer
counts its hazardous waste
pharmaceuticals towards its monthly
hazardous waste generator category, it
may no longer be an LQG. As a result,
it is possible that the healthcare facility
may not need to manage its non-
pharmaceutical hazardous waste
pursuant to the LQG regulations in
§
262.17, but rather can operate under
the reduced regulations for SQGs in
§
262.16 or for VSQGs in §
262.14. In
addition, if a healthcare facility that is
a VSQG does not want to keep track of
the amount of hazardous waste
pharmaceuticals it generates to ensure it
does not exceed the VSQG quantity
limits, it can choose to operate under
this final rule. If it chooses to operate
under this final rule, however, a
healthcare facility must comply with all
the requirements of this subpart for the
management of its hazardous waste
pharmaceuticals.
Following publication of the final
rule, EPA plans extensive outreach to
educate healthcare facilities and reverse
distributors on the provisions of this
final rule.
B. Reverse Distributors and Reverse
Logistics Centers
1. Prescription Pharmaceuticals Sent to
Reverse Distributors Are Solid Wastes
EPA proposed to change how RCRA
would apply to pharmaceuticals
returned to reverse distributors to obtain
manufacturers credit. EPA proposed
that the decision by a healthcare facility
to send a pharmaceutical to a reverse
distributor is the decision to discard the
pharmaceutical. Due to many comments
on this proposed change, the Agency is
now making a clear distinction in the
final rule between reverse distribution,
in the case of prescription
pharmaceuticals, and reverse logistics in
the case of all other pharmaceuticals-
including over-the counter
pharmaceuticals and dietary
supplements, as well as other unsold
consumer items (see section VI for a
discussion of the comments). EPA is
finalizing that the decision by a
healthcare facility to send a prescription
pharmaceutical to a reverse distributor
is the decision to discard the
prescription pharmaceutical. Therefore,
under this final rule, once the
healthcare facility makes the decision to
send a prescription pharmaceutical to a
reverse distributor for credit, it is a solid
waste at the healthcare facility. A
portion of the potentially creditable
solid waste prescription
pharmaceuticals at healthcare facilities
that are destined for a reverse
distributor will also meet the definition
of hazardous waste and as a result, these
potentially creditable hazardous waste
prescription pharmaceuticals would
need to be managed in accordance with
the final 40 CFR part 266 subpart P
requirements.
In addition, the Agency notes that the
change in EPA's position concerning
reverse distribution and the
management standards discussed in this
final rule pertain only to the reverse
distribution of prescription hazardous
waste pharmaceuticals and does not
apply to the reverse logistics of other
pharmaceuticals or to the reverse
logistics systems that may exist for other
unsold consumer items.
2. Nonprescription Pharmaceuticals
Sent to Reverse Logistics Centers Are
Not Solid Wastes
EPA proposed that the decision by a
healthcare facility to send any
pharmaceutical to a reverse distributor
is the decision to discard the
pharmaceutical, but is now making a
clear distinction in the final rule
between reverse distribution of
prescription pharmaceuticals and
reverse logistics of nonprescription
pharmaceuticals and other unsold retail
items. In response to comments, EPA is
codifying our previous policy that the
decision by a healthcare facility to send
nonprescription pharmaceuticals to a
reverse logistics center is not a decision
to discard if the nonprescription
pharmaceuticals have a reasonable
expectation of being legitimately used/
reused (e.g., lawfully redistributed for
their intended purpose) or reclaimed. In
other words, EPA is finalizing that
nonprescription pharmaceuticals are not
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468
See the docket for this rulemaking EPA-HQ-
RCRA-2007-0932-0173.
469
See the 2008 interim enforcement policy in
the docket for this rulemaking EPA-HQ-RCRA-
2007-0932-0181.
470
See the 2017 interim enforcement policy at
https://fortress.wa.gov/ecy/publications/
documents/0704024.pdf or in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932).
471
See the guidance document in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932-
0178).
solid wastes, and therefore not
hazardous waste pharmaceuticals if they
have a reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for their intended purpose)
or reclaimed.
3. Reverse Distributors Managing
Hazardous Waste Pharmaceuticals
Under Part 266 Subpart P
EPA is finalizing that all reverse
distributors are subject to 40 CFR part
266 subpart P and will be subject to the
same standards with respect to their
hazardous waste pharmaceuticals,
regardless of the amount of hazardous
waste pharmaceuticals they manage.
Even reverse distributors that are
currently VSQGs will be regulated
under 40 CFR part 266 subpart P for the
management of their hazardous waste
pharmaceuticals. Therefore, a reverse
distributor subject to 40 CFR part 266
subpart P will no longer have to keep
track of the amount of hazardous waste
pharmaceuticals that it generates on a
monthly basis.
C. Healthcare Facilities and Reverse
Distributors Managing Non-
Pharmaceutical Hazardous Waste in
Accordance With 40 CFR Part 262 or
Part 273 (i.e., Complying With ''More
Than One RCRA'')
Most, if not all, healthcare facilities
and reverse distributors generate at least
some hazardous wastes other than
pharmaceuticals. These non-
pharmaceutical hazardous wastes will
continue to be regulated under 40 CFR
part 262 (and other applicable Subtitle
C regulations). The standards
established by this rulemaking apply
only to the management of hazardous
waste pharmaceuticals at healthcare
facilities and reverse distributors.
Healthcare facilities and reverse
distributors likely generate or manage
other types of hazardous wastes. For
example, hospitals may generate non-
pharmaceutical hazardous wastes, such
as solvents in their diagnostic
laboratories; those hazardous wastes
must still be managed in accordance
with the part 262 generator regulations
(such as the RCRA SAA regulations
(§
262.15)), or if it is a teaching hospital,
the Academic Laboratories Rule (if it
has opted into part 262 subpart K).
Retail stores, including pharmacies and
grocery stores, may have non-
pharmaceutical hazardous wastes on-
site as well, which must be managed in
accordance with the 40 CFR part 262
regulations and all other applicable
RCRA Subtitle C regulations. For
example, fluorescent bulbs may be
managed under the universal waste
program (40 CFR part 273). For reverse
distributors, this rule only applies to the
management of potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals. Some reverse
distributors may generate other non-
pharmaceutical hazardous wastes from
activities, such as cleaning and
maintenance; other RCRA Subtitle C
regulations will apply to those non-
pharmaceutical hazardous wastes.
D. State Enforcement Activities and
Interpretations
States have taken a variety of
approaches regarding hazardous waste
pharmaceuticals. One major goal of this
final rule is to provide clarity on this
topic, and thereby promote national
consistency, which should promote
better compliance among healthcare
facilities, including pharmacies.
In 2012, Connecticut's Department of
Energy and Environmental Protection
(DEEP) took enforcement actions at
seven CVS stores for violations of the
RCRA hazardous waste regulations.
Consent orders from CT DEEP direct
CVS stores in the state to follow a set
of best management practices.
468
A
number of the practices developed in
these consent orders mirror some of the
practices EPA is finalizing in this rule,
particularly with regard to
pharmaceuticals destined for a reverse
distributor. CT DEEP asserts RCRA
jurisdiction over the pharmaceuticals
destined for reverse distributors by
applying specific management practices.
For example, CVS must maintain
records of each shipment of non-
dispensable pharmaceuticals to a
reverse distributor, including
confirmation of receipt of the non-
dispensable pharmaceuticals from the
receiving reverse distributor. The best
practices also include procedures for
addressing situations when CVS does
not receive delivery confirmation of
shipment to a reverse distributor.
Further, the consent order sets out
separate, more comprehensive practices
for the non-dispensable pharmaceuticals
that are not suitable for reverse
distribution.
Aside from best management
practices developed by Connecticut as
part of a consent order, at least two
other states have developed guidance
documents that apply conditions to the
management of hazardous wastes
pharmaceuticals in exchange for
enforcement discretion. In particular, in
2008, the Washington State Department
of Ecology issued guidance titled,
Interim Enforcement Policy:
Pharmaceutical Waste in Healthcare.
469
This interim enforcement discretion
policy had some elements in common
with this final rule for hazardous waste
pharmaceuticals. For instance, a
healthcare facility was required to notify
the Department of Ecology that it was
operating under the policy and had to
train its staff involved in
pharmaceutical waste management.
Only a time limit, rather than a quantity
limit, applied to the accumulation of the
hazardous waste pharmaceuticals on
site. Of particular note is that
Washington State prohibited disposing
of most hazardous waste
pharmaceuticals down the toilet or
drain. In anticipation of this final rule,
Washington State updated the interim
policy in June 2017 to provide regulated
facilities with the opportunity to use
some of the provisions outlined in the
proposed rulemaking, such as allowing
facilities to send creditable
pharmaceuticals to a reverse distributor
for evaluation without providing
hazardous waste codes.
470
In 2011, Minnesota's Pollution
Control Agency (MPCA) issued a fact
sheet titled Reverse Distribution of
Pharmaceuticals: Guidance for
Minnesota Healthcare Providers.
471
In
this guidance, Minnesota states,
''Whether a pharmaceutical is eligible
for return credit does not affect its
product or waste status. In Minnesota, if
a pharmaceutical is not used or reused
for its intended purpose, it is a waste.
The MPCA considers health care
practitioners and pharmacies to be
generators of these pharmaceutical
wastes. Nevertheless, the MPCA
believes that the established reverse
distribution system provides an
environmentally protective method for
handling waste pharmaceuticals.
Therefore, it will allow Minnesota
health care practitioners and
pharmacies to manage certain
pharmaceuticals through reverse
distribution, subject to additional
requirements discussed in this fact
sheet.'' This is similar to the approach
that EPA is finalizing for potentially
creditable hazardous waste
pharmaceuticals. For example, like
EPA's final rule, MPCA does not require
hazardous waste pharmaceuticals
destined for a reverse distributor to be
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472
See November 28, 2016; 81 FR 85732.
473
See the definition of very small quantity
generator in 40 CFR 2601.10.
474
See 40 CFR 262.18(d)(1).
475
See 81 FR 85777-8; November 28, 2016 for the
preamble discussion explaining the need for re-
notification.
476
Or more than 100 kg of any residue or
contaminated soil, water, or other debris resulting
from the cleanup of a spill, into or on any land or
water, of any acute hazardous waste listed in
§
261.31 or 261.33(e).
477
Or more than 100 kg of any residue or
contaminated soil, water, or other debris resulting
from the cleanup of a spill, into or on any land or
water, of any acute hazardous waste listed in
§
261.31 or 261.33(e).
counted toward determining a
healthcare facility's generator category.
In addition, MPCA does not require
hazardous waste pharmaceuticals to be
accompanied by a hazardous waste
manifest when shipped to a reverse
distributor. By finalizing a rule that is
consistent with state approaches, EPA is
bringing national consistency to the
management of hazardous waste
pharmaceuticals, while avoiding
disruption to practices already in place.
E. Intersection of Part 266 Subpart P
With the Hazardous Waste Generator
Improvements Rule
The Hazardous Waste Generator
Improvements rule was finalized on
November 28, 2016.
472
This rule
finalized a much-needed update to the
hazardous waste generator regulations
in part 262 to make the rules easier to
understand, facilitate better compliance,
provide greater flexibility in how
hazardous waste is managed and close
important gaps in the regulations. This
section of preamble discusses three
portions of the Hazardous Waste
Generator Improvements final rule that
might impact healthcare facilities and
reverse distributors that are subject to
part 266 subpart P.
1. Episodic Generation
One of the key provisions with which
EPA added regulatory flexibility allows
a hazardous waste generator to avoid
increased burden of a higher generator
category when generating episodic
waste provided the episodic waste is
properly managed in accordance with
part 262 subpart L. Healthcare facilities
and reverse distributors will be able to
take advantage of this added regulatory
flexibility (assuming their state has
adopted this provision).
A healthcare facility that is a VSQG
for both hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste can
use the episodic generation provision of
part 262 subpart L for all of its
hazardous waste, including its
hazardous waste pharmaceuticals. If a
healthcare facility is generally operating
under §
262.14 as a VSQG, but has an
episodic event, it would be far less
burdensome to comply with part 262
subpart L than to come into compliance
with all the provisions of part 266
subpart P for the short duration of the
episodic event. For example, if a VSQG
healthcare facility is directed to dispose
of recalled pharmaceuticals, it could use
the episodic generator provisions of part
262 subpart L to avoid an increase in
hazardous waste generator category.
However, if a healthcare facility that is
a VSQG generates hazardous waste in
excess of the allowable amounts as a
VSQG,
473
and it chooses not to use the
episodic generator provisions in part
262 subpart L, it would become subject
to part 266 subpart P for its hazardous
waste pharmaceuticals.
As discussed previously, healthcare
facilities and reverse distributors that
are subject to part 266 subpart P for
their hazardous waste pharmaceuticals
may still be subject to part 262 for the
management of their non-
pharmaceutical hazardous waste. A
healthcare facility or reverse distributor
operating under part 266 subpart P for
its hazardous waste pharmaceuticals
may not use the episodic generator
standards of part 262 subpart L with
respect to its hazardous waste
pharmaceuticals. Under part 266
subpart P, all healthcare facilities are
regulated the same regardless of
amounts of hazardous waste
pharmaceuticals generated and all
reverse distributors are regulated the
same, regardless of amounts of
hazardous waste pharmaceuticals
managed, making the need for episodic
generation provisions unnecessary. On
the other hand, if a healthcare facility or
reverse distributor is generally operating
as a VSQG or SQG for its non-
pharmaceutical hazardous waste, but
has an episodic event, the healthcare
facility may use the provisions in part
262 subpart L for its non-
pharmaceutical hazardous waste.
2. Small Quantity Generator Re-
Notification
The 2016 Hazardous Waste Generator
Improvements final rule added a new
requirement for periodic re-notification
by SQGs.
474
Under this new provision,
SQGs must re-notify EPA starting in
2021 and every four years thereafter
using EPA Form 8700-12. This re-
notification must be submitted by
September 1st of each year in which re-
notifications are required.
475
Healthcare
facilities and reverse distributors
operating under part 266 subpart P may
also be subject to part 262 for the
management of its non-pharmaceutical
hazardous waste. If a healthcare facility
or reverse distributor is an SQG for its
non-pharmaceutical hazardous waste,
then it will be subject to this re-
notification requirement under part 262.
Therefore, in order to avoid duplicative
notification requirements, under part
266 subpart P, EPA is not requiring re-
notification by healthcare facilities and
reverse distributors.
3. Very Small Quantity Generators That
Accumulate More Than 1 Kg of Acute
Hazardous Waste
The 2016 Hazardous Waste Generator
Improvements final rule clarified in
§
262.14(a)(3) that if a VSQG
accumulates at any time greater than 1
kg of acute hazardous waste,
476
all
quantities of that acute hazardous waste
are subject to the additional conditions
for exemption for LQGs. More
specifically, the acute hazardous waste
must be held on site for no more than
90 days beginning on the date when
more than 1 kg is exceeded, and the
acute hazardous waste is subject to the
LQG conditions for exemption in
§
262.17(a) through (g). In other words,
while the acute hazardous waste
becomes subject to the stricter standards
for LQGs when the accumulation limits
are exceeded, the generator continues to
be considered a VSQG, provided the
generator continues to generate within
the VSQG thresholds identified in the
definition of VSQG in §
260.10.
If a healthcare facility that is a VSQG
accumulates more than 1 kg of acute
hazardous waste,
477
then it will remain
subject to §
262.14(a)(3); the healthcare
facility will not become subject to part
262 subpart P.
XX. State Authorization
A. Applicability of Rules in Authorized
States
Under section 3006 of RCRA, EPA
may authorize states to administer the
RCRA Subtitle C hazardous waste
program. Following authorization, the
authorized state program operates in
lieu of the federal regulations. EPA
retains authority to enforce the
authorized state Subtitle C program,
although authorized states have primary
enforcement authority. EPA also retains
its authority under RCRA sections 3007,
3008, 3013, and 7003. The standards
and requirements for state authorization
are found at 40 CFR part 271.
Prior to enactment of the Hazardous
and Solid Waste Amendments of 1984
(HSWA), a state with final RCRA
authorization administered its
hazardous waste program entirely in
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478
EPA notes that decisions regarding whether a
state rule is more stringent or broader in scope than
the federal program are made when the Agency
authorizes a state program for a particular rule.
lieu of EPA administering the federal
program in that state. EPA did not issue
permits for any facilities in that state,
since the state was now authorized to
issue RCRA permits. When new, more
stringent federal requirements were
promulgated, the state was obligated to
enact equivalent authorities within
specified time frames. However, the
new requirements did not take effect in
an authorized state until the state
adopted the equivalent state
requirements.
In contrast, under RCRA section
3006(g) (42 U.S.C. 6926(g)), which was
added by HSWA, new requirements and
prohibitions imposed under HSWA
authority take effect in authorized states
at the same time that they take effect in
unauthorized states. While states must
still adopt HSWA-related provisions as
state law to retain authorization, EPA
implements the HSWA provisions in
authorized states, including the
issuance of any permits pertaining to
HSWA requirements, until the state is
granted authorization to do so.
Authorized states are required to
modify their programs only when EPA
promulgates federal requirements that
are more stringent or broader in scope
than existing federal requirements.
478
RCRA section 3009 allows the states to
impose standards more stringent than
those in the federal program (see 40 CFR
271.1). Therefore, authorized states may,
but are not required to, adopt federal
regulations, both HSWA and non-
HSWA, that are considered less
stringent than previous federal
regulations.
B. Effect on State Authorization
This action adds a new subpart P to
40 CFR part 266, and it is being
finalized in part under the authority of
HSWA and in part under non-HSWA
authority. The bulk of 40 CFR part 266
subpart P is being finalized under non-
HSWA authority. Thus, the
amendments promulgated under non-
HSWA authority are applicable on the
effective date only in those states that
do not have final authorization of their
base RCRA programs. Only the
prohibition of sewering hazardous waste
pharmaceuticals (§
266.504) is being
finalized under HSWA authority in
section 3018 of RCRA. The amendments
promulgated under the authority of
HSWA (i.e., the prohibition on sewering
hazardous waste pharmaceuticals) are
applicable on the effective date of the
final rule in all states. Moreover,
authorized states are required to modify
their programs only when EPA
promulgates federal regulations that are
more stringent or broader in scope than
the authorized state regulations. For
those changes that are less stringent,
states are not required to modify their
programs.
While some provisions of part 266
subpart P are considered less stringent
than the current federal standards, other
provisions of the final rule are
considered more stringent than the
current federal standards. Taken as a
whole, we consider the entire new
subpart P under 40 CFR part 266
entitled ''Standards for the Management
of Specific Hazardous Wastes and
Specific Types of Hazardous Waste
Management Facilities'' (sections VIII-
XVII of this preamble) to be more
stringent than the current federal
standards. Therefore, authorized states
will be required to modify their
programs to adopt these revisions.
When a state adopts this new subpart,
if elements of the state program are
more stringent than this new subpart,
the state has the option of retaining
those more stringent elements.
Likewise, when a state adopts this new
subpart, the state has the option of
adding elements that are more stringent
or broader in scope than this new
subpart.
On the other hand, one final revision
is less stringent than the current
hazardous waste regulations. The
amendment to exempt from the P075
listing the nicotine patches, gums and
lozenges that are FDA-approved OTC
nicotine replacement therapies is less
stringent that the current hazardous
waste regulations (section V of this
preamble). Thus, authorized states may,
but are not required to, adopt the change
to the P075 listing.
C. Effect on State Authorization in
States That Have Added
Pharmaceuticals to the Universal Waste
Program
The Universal Waste program allows
states to add waste streams to their own
state program, even when the waste
stream has not been added to the federal
Universal Waste program, provided the
state has adopted and been authorized
for the petition process in §§
260.20 and
260.23. Two states have added
hazardous waste pharmaceuticals to
their Universal Waste programs: Florida
and Michigan. Because the added
subpart P under CFR part 266 is
considered more stringent than either
the ''traditional RCRA'' standards or the
Universal Waste program, both Florida
and Michigan will be required to modify
their programs to adopt an approach at
least as stringent as the amendments.
Furthermore, because the Agency has
determined that it is not appropriate to
add hazardous waste pharmaceuticals to
the Universal Waste program, both
Florida and Michigan must remove
hazardous waste pharmaceuticals from
their Universal Waste program when
they adopt this new subpart, although
they may continue to regulate non-
hazardous waste pharmaceuticals under
the Universal Waste program, to the
extent allowed under state law. In
addition, states may choose to add non-
hazardous waste pharmaceuticals to
their Universal Waste program or may
regulate them more stringently as part of
their hazardous waste program but
states may not add hazardous waste
pharmaceuticals to their Universal
Waste program in the future.
Accordingly, we have amended the
regulations in §
273.80(a) and added
§
273.80(d) to reflect this decision that
states may not add hazardous waste
pharmaceuticals to their Universal
Waste program.
XXI. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is a significant regulatory
action that was submitted to the Office
of Management and Budget (OMB) for
review. Pursuant to the terms of
Executive Order 12866, as affirmed in
Executive Order 13563, the Agency has
determined that this rule is a significant
regulatory action because it contains
novel policy issues, as defined under
section 3(f)(4) of the Order. Any changes
made in response to OMB
recommendations have been
documented in the docket.
As discussed in section I above, EPA
prepared an economic analysis of the
potential costs and benefits associated
with this action. This analysis,
Regulatory Impact Analysis for EPA's
Final Regulations for the Management
of Hazardous Waste Pharmaceuticals,
indicates that the rule is projected to
result in net annual cost savings of
approximately $12.99 million to $14.96
million based on a discount rate of 7
percent or $12.98 to $14.95 million
based on a discount rate of 3 percent.
The full analysis is available in the
docket for this rule.
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
This action is considered an
Executive Order 13771 deregulatory
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action. Details on the estimated cost
savings of this final rule can be found
in EPA's analysis of the potential costs
and benefits associated with this action.
C. Paperwork Reduction Act
The information collection activities
in this rule have been submitted for
approval to the Office of Management
and Budget (OMB) under the PRA. The
Information Collection Request (ICR)
document that EPA prepared has been
assigned EPA ICR number 2486.02,
OMB control number 0250-0212. You
can find a copy of the ICR in the docket
for this rule, and it is briefly
summarized here.
EPA is finalizing in this rule, under a
new subpart P to 40 CFR part 266, new
and revised reporting and recordkeeping
requirements for healthcare facilities
and reverse distributors. These
requirements, which are also identified
in the ICR supporting this action, will
enable EPA and state regulatory
agencies to identify the universe of
healthcare facilities managing
hazardous waste pharmaceuticals. In
addition, the requirements include
provisions for tracking of hazardous
waste pharmaceuticals that are sent to
reverse distributors.
EPA will use the collected
information to ensure that hazardous
waste pharmaceuticals are being
managed in a protective manner. The
tracking requirements ensure that these
wastes arrive at their intended
destinations rather than diverted for
illicit purposes or managed at facilities
not equipped to manage these wastes.
These tracking requirements will also
help facilities identify shipments that
do not arrive at their destination as
planned, allowing generators to take
corrective action that will ensure that
future shipments are transported to the
appropriate location. Information
marked on containers of hazardous
waste pharmaceuticals will assist
handlers and transporters in ensuring
proper management during storage and
shipment.
Respondents/affected entities: Drug
wholesalers, supermarkets and other
grocery stores, pharmacies and drug
stores, warehouse clubs and
supercenters, veterinary clinics,
physicians' offices, dentists' offices,
other health practitioners, outpatient
care centers, other ambulatory health
care services, hospitals, nursing care
facilities, continuing care retirement
communities, and reverse distributors.
Respondent's obligation to respond:
The recordkeeping and notification
requirements are mandatory and are
being promulgated under section 3001
of RCRA.
Estimated number of respondents:
13,373.
Frequency of response: The frequency
of response varies.
Total estimated burden: EPA
estimated the total annual burden to
respondents to be approximately 43,577
hours. Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: EPA estimated
the total estimated annual cost of this
paperwork burden to respondents to be
approximately $2,543,409.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for the EPA's regulations in 40
CFR are listed in 40 CFR part 9. When
OMB approves this ICR, the Agency will
announce that approval in the Federal
Register and publish a technical
amendment to 40 CFR part 9 to display
the OMB control number for the
approved information collection
activities contained in this final rule.
D. Regulatory Flexibility Act
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. In making this
determination, the impact of concern is
any significant adverse economic
impact on small entities. An agency may
certify that a rule will not have a
significant economic impact on a
substantial number of small entities if
the rule relieves regulatory burden, has
no net burden or otherwise has a
positive economic effect on the small
entities subject to the rule. As
documented in the Regulatory Impact
Analysis found in the docket for this
proposal, EPA does not expect the rule
to result in an adverse impact to a
significant number of small entities.
EPA estimates that there are at least
10,481 to 15,114 small entities that will
be impacted by this rule. However,
small entities are expected to experience
a net cost savings under the final rule,
and for the small entities that are
expected to experience a net cost under
the final rule, the RIA estimates the
costs, at most, to represent 0.013 percent
of annual revenues for small entities.
We have therefore concluded that this
action will either relieve regulatory
burden or have no net regulatory burden
for all directly regulated small entities.
E. Unfunded Mandates Reform Act
As documented in the Regulatory
Impact Analysis found in the docket for
this rule, this action does not contain an
unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or
uniquely affect small governments. As
indicated previously, the annual net
cost savings is estimated to be between
approximately $13 million and $15
million (based on a discount rate of
7%). Thus, this rule is not subject to the
requirements of sections 202 or 205 of
UMRA.
This rule is also not subject to the
requirements of section 203 of UMRA
because it contains no regulatory
requirements that might significantly or
uniquely affect small governments.
While some hospitals are publicly
owned, the requirements affecting those
facilities are not unique in that they are
the same as those affecting all facilities
in the proposed rulemaking. Also, using
data on revenues of hospitals owned by
state and local governments, EPA
estimated that the costs of the rule borne
by state and local governments
represent less than 0.001% of their
revenues. Therefore, the costs incurred
by small governments are not expected
to be significant.
F. Executive Order 13132: Federalism
As documented in the Regulatory
Impact Analysis found in the docket for
this rule, this action does not have
federalism implications. It will not have
substantial direct effects on the states,
on the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
G. Executive Order 13175: Consultation
With Tribal Governments
This action may have tribal
implications as specified in Executive
Order 13175. The final rule will neither
impose substantial direct compliance
costs on tribal government, not preempt
tribal law. Under the RCRA statute, the
federal government implements
hazardous waste regulations directly in
Indian Country. Thus, the final rule
would not impose any direct costs on
tribal governments.
To assess the potential tribal
implications of the action, EPA
compiled data on the number of tribally
run healthcare facilities in the U.S. and
estimated the costs of this action for
these facilities. As documented in the
Regulatory Impact Analysis in the
docket for this rule, the rule is not
expected to impose a substantial burden
on tribal governments.
EPA consulted with tribal officials
under the EPA Policy on Consultation
and Coordination with Indian Tribes
early in the process of developing this
regulation to permit them to have
meaningful and timely input into its
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development. A summary of that
consultation is provided in the docket
for this rule (see EPA-HQ-RCRA-2008-
0932).
As required by section 7(a), the EPA's
Tribal Consultation Official has certified
that the requirements of the executive
order have been met in a meaningful
and timely manner. A copy of the
certification is included in the docket
for this action.
H. Executive Order 13045: Children's
Health
This action is not subject to Executive
Order 13045 because it is not
economically significant as defined in
Executive Order 12866 and because the
EPA does not believe the environmental
health or safety risks addressed by this
proposed action present a
disproportionate risk to children. This
action's health and risk assessments are
contained in the Regulatory Impact
Analysis for EPA's Final Regulations for
the Management of Hazardous Waste
Pharmaceuticals, found in the docket
for this action.
I. Executive Order 13211: Energy Supply
This action is not a ''significant
energy action'' because it is not likely to
have a significant adverse effect on the
supply, distribution or use of energy.
The final rule does not directly regulate
energy production or consumption.
Changes in the management of
hazardous waste pharmaceuticals
stipulated in this action are not
expected to impact energy production or
distribution and will have minimal
impact on energy consumptions.
J. National Technology Transfer and
Advancement Act
This final rulemaking does not
involve technical standards.
K. Executive Order 12898:
Environmental Justice
EPA believes that this action does not
have disproportionately high and
adverse human health or environmental
effects on minority populations, low-
income populations and/or indigenous
peoples, as specified in Executive Order
12898 (59 FR 7629, February 16, 1994).
The documentation for this decision is
contained in the Regulatory Impact
Analysis, which can be found at
regulations.gov under docket number
EPA-HQ-RCRA-2007-0932.
To meet the requirements of
Executive Order 12898, EPA analyzed
potential environmental justice impacts
associated with the diversion of
hazardous waste pharmaceuticals from
sewer disposal to hazardous waste
combustion facilities. Populations living
near and downstream from wastewater
treatment plants may also benefit from
the elimination of sewering of
hazardous waste pharmaceuticals. To
the extent that minority and/or low-
income populations near or downstream
from wastewater treatment plants make
up a disproportionately high portion of
the overall population, this final action
may result in positive environmental
justice impacts.
Overall, EPA expects that this action
may positively affect U.S.
environmental justice populations,
although the size of the impact will vary
by wastewater treatment plant. A
reduction in sewering expected under
the final rule may benefit relatively
large minority and low-income
populations in close proximity to or
downstream from wastewater treatment
plants. The diversion of hazardous
waste pharmaceuticals from wastewater
treatment plants to combustion
facilities, however, may increase the
environmental burden borne by
environmental justice populations near
these combustion facilities. Although
these effects offset each other to a
certain degree, the number of minority
and low-income individuals near
wastewater treatment facilities exceeds
the number near hazardous waste
combustion facilities. This suggests that,
on the whole, the final action may
benefit environmental justice
populations.
L. Congressional Review Act
EPA will submit a report containing
this rule and other information required
by the Congressional Review Act (5
U.S.C. 801 et seq.) to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication in the
Federal Register. A major rule cannot
take effect until sixty (60) days after it
is published in the Federal Register.
This action is not a ''major rule'' as
defined by 5 U.S.C. 804(2). This final
authorization will be effective August
22, 2019.
List of Subjects
40 CFR Part 261
Environmental protection, Hazardous
waste, Recycling, Reporting and
recordkeeping requirements.
40 CFR Part 262
Environmental protection, Exports,
Hazardous materials transportation,
Hazardous waste, Imports, Labeling,
Packaging and containers, Reporting
and recordkeeping requirements.
40 CFR Part 264
Environmental protection, Air
pollution control, Hazardous waste,
Insurance, Packaging and containers,
Reporting and recordkeeping
requirements, Security measures, Surety
bonds.
40 CFR Part 265
Environmental protection, Air
pollution control, Hazardous waste,
Insurance, Packaging and containers,
Reporting and recordkeeping
requirements, Security measures, Surety
bonds, Water supply.
40 CFR Part 266
Environmental protection, Energy,
Hazardous waste, Recycling, Reporting
and recordkeeping requirements.
40 CFR Part 268
Environmental protection, Hazardous
waste, Reporting and recordkeeping
requirements.
40 CFR Part 270
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous materials transportation,
Hazardous waste, Reporting and
recordkeeping requirements, Water
pollution control, Water supply.
40 CFR Part 273
Environmental protection, Hazardous
materials transportation, Hazardous
waste.
Dated: December 11, 2018.
Andrew R. Wheeler,
Acting Administrator.
For the reasons stated in the
preamble, Title 40, chapter I, of the
Code of Federal Regulations is amended
as follows:
PART 261-IDENTIFICATION AND
LISTING OF HAZARDOUS WASTE
■
1. The authority citation for part 261
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921,
6922, 6924(y) and 6938.
■
2. Section 261.4 is amended by
revising paragraph (a)(1)(ii) to read as
follows:
§
261.4
Exclusions.
(a) *
*
*
(1) *
*
*
(ii) Any mixture of domestic sewage
and other wastes that passes through a
sewer system to a publicly-owned
treatment works for treatment, except as
prohibited by §
266.505 and Clean
Water Act requirements at 40 CFR
403.5(b). ''Domestic sewage'' means
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1
CAS Number given for parent compound only.
untreated sanitary wastes that pass
through a sewer system.
* * * * *
■
3. Section 261.7 is amended by adding
paragraph (c) to read as follows:
§
261.7
Residues of hazardous waste in
empty containers.
* * * * *
(c) Containers of hazardous waste
pharmaceuticals are subject to §
266.507
for determining when they are
considered empty, in lieu of this
section, except as provided by
§
266.507(c) and (d).
■
4. Section 261.33 is amended by:
■
a. Revising paragraph (c); and
■
b. Revising the four entries for ''P075''
in the table in paragraph (e).
The revisions read as follows:
§
261.33
Discarded commercial chemical
products, off-specification species,
container residues, and spill residues
thereof.
* * * * *
(c) Any residue remaining in a
container or in an inner liner removed
from a container that has held any
commercial chemical product or
manufacturing chemical intermediate
having the generic name listed in
paragraphs (e) or (f) of this section,
unless the container is empty as defined
in §
261.7(b) or §
266.507 of this chapter.
[Comment: Unless the residue is being
beneficially used or reused, or
legitimately recycled or reclaimed; or
being accumulated, stored, transported
or treated prior to such use, re-use,
recycling or reclamation, EPA considers
the residue to be intended for discard,
and thus, a hazardous waste. An
example of a legitimate re-use of the
residue would be where the residue
remains in the container and the
container is used to hold the same
commercial chemical product or
manufacturing chemical intermediate it
previously held. An example of the
discard of the residue would be where
the drum is sent to a drum reconditioner
who reconditions the drum but discards
the residue.]
* * * * *
(e) *
*
*
Hazardous
waste No.
Chemical
abstracts
No.
Substance
*
*
*
*
*
*
*
P075
...............
1
54-11-5 Nicotine, & salts (this listing does not include patches, gums and lozenges that are FDA-approved over-the-
counter nicotine replacement therapies).
*
*
*
*
*
*
*
P075
...............
1
54-11-5 Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)-, & salts (this listing does not include patches, gums and lozenges
that are FDA-approved over-the-counter nicotine replacement therapies).
*
*
*
*
*
*
*
P075
...............
1
54-11-5 Nicotine, & salts (this listing does not include patches, gums and lozenges that are FDA-approved over-the-
counter nicotine replacement therapies).
*
*
*
*
*
*
*
P075
...............
1
54-11-5 Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)-, & salts (this listing does not include patches, gums and lozenges
that are FDA-approved over-the-counter nicotine replacement therapies).
*
*
*
*
*
*
*
* * * * *
PART 262-STANDARDS APPLICABLE
TO GENERATORS OF HAZARDOUS
WASTE
■
5. The authority citation for part 262
continues to read as follows:
Authority: 42 U.S.C. 6906, 6912, 6922-
6925, 6937, 6938, and 6939g.
■
6. Section 262.10 is amended by
adding paragraphs (m) and (n) to read as
follows:
§
262.10
Purpose, scope and applicability.
* * * * *
(m) All reverse distributors (as
defined in §
266.500) are subject to 40
CFR part 266 subpart P for the
management of hazardous waste
pharmaceuticals in lieu of this part.
(n) Each healthcare facility (as defined
in §
266.500) must determine whether it
is subject to 40 CFR part 266 subpart P
for the management of hazardous waste
pharmaceuticals, based on the total
hazardous waste it generates per
calendar month (including both
hazardous waste pharmaceuticals and
non-pharmaceutical hazardous waste).
A healthcare facility that generates more
than 100 kg (220 pounds) of hazardous
waste per calendar month, or more than
1 kg (2.2 pounds) of acute hazardous
waste per calendar month, or more than
100 kg (220 pounds) per calendar month
of any residue or contaminated soil,
water, or other debris, resulting from the
clean-up of a spill, into or on any land
or water, of any acute hazardous wastes
listed in §
261.31 or §
261.33(e), is
subject to 40 CFR part 266 subpart P for
the management of hazardous waste
pharmaceuticals in lieu of this part. A
healthcare facility that is a very small
quantity generator when counting all of
its hazardous waste, including both its
hazardous waste pharmaceuticals and
its non-pharmaceutical hazardous
waste, remains subject to §
262.14 and is
not subject to part 266 subpart P, except
for §§
266.505 and 266.507 and the
optional provisions of §
266.504.
■
7. Section 262.13 is amended by
adding paragraph (c)(9) to read as
follows:
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§
262.13
Generator category
determination.
* * * * *
(c) *
*
*
(9) Is a hazardous waste
pharmaceutical, as defined in §
266.500,
that is subject to or managed in
accordance with 40 CFR part 266
subpart P or is a hazardous waste
pharmaceutical that is also a Drug
Enforcement Administration controlled
substance and is conditionally exempt
under §
266.506.
* * * * *
■
8. Section 262.14 is amended by
adding paragraphs (a)(5)(ix) and (x) to
read as follows:
§
262.14
Conditions for exemption for a
very small quantity generator.
(a) *
*
*
(5) *
*
*
(ix) A reverse distributor (as defined
in §
266.500), if the hazardous waste
pharmaceutical is a potentially
creditable hazardous waste
pharmaceutical generated by a
healthcare facility (as defined in
§
266.500).
(x) A healthcare facility (as defined in
§
266.500) that meets the conditions in
§§
266.502(l) and 266.503(b), as
applicable, to accept non-creditable
hazardous waste pharmaceuticals and
potentially creditable hazardous waste
pharmaceuticals from an off-site
healthcare facility that is a very small
quantity generator.
* * * * *
PART 264-STANDARDS FOR
OWNERS AND OPERATORS OF
HAZARDOUS WASTE TREATMENT,
STORAGE, AND DISPOSAL
FACILITIES
■
9. The authority citation for part 264
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6924,
6925, and 6939g.
■
10. Section 264.1 is amended by
adding paragraph (g)(13) to read as
follows:
§
264.1
Purpose, scope and applicability.
* * * * *
(g) *
*
*
(13) Reverse distributors
accumulating potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals, as defined in
§
266.500. Reverse distributors are
subject to regulation under 40 CFR part
266 subpart P in lieu of this part for the
accumulation of potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals.
* * * * *
PART 265-INTERIM STATUS
STANDARDS FOR OWNERS AND
OPERATORS OF HAZARDOUS WASTE
TREATMENT, STORAGE, AND
DISPOSAL FACILITIES
■
11. The authority citation for part 265
continues to read as follows:
Authority: 42 U.S.C. 6905, 6906, 6912,
6922, 6923, 6924, 6925, 6935, 6936, 6937,
and 6939g.
■
12. Section 265.1 is amended by
adding paragraph (c)(16) to read as
follows:
§
265.1
Purpose, scope, and applicability.
* * * * *
(c) *
*
*
(16) Reverse distributors
accumulating potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals, as defined in
§
266.500. Reverse distributors are
subject to regulation under 40 CFR part
266 subpart P in lieu of this part for the
accumulation of potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals.
* * * * *
PART 266-STANDARDS FOR THE
MANAGEMENT OF SPECIFIC
HAZARDOUS WASTES AND SPECIFIC
TYPES OF HAZARDOUS WASTE
MANAGEMENT FACILITIES
■
13. The authority citation for part 266
continues to read as follows:
Authority: 42 U.S.C. 1006, 2002(a), 3001-
3009, 3014, 3017, 6905, 6906, 6912, 6921,
6922, 6924-6927, 6934, and 6937.
Subpart O-[Reserved]
■
14. Add reserved subpart O.
■
15. Add subpart P, consisting of
§§
266.500 through 266.510, to read as
follows:
Subpart P-Hazardous Waste
Pharmaceuticals
Sec.
266.500
Definitions for this subpart.
266.501
Applicability.
266.502
Standards for healthcare facilities
managing non-creditable hazardous
waste pharmaceuticals.
266.503
Standards for healthcare facilities
managing potentially creditable
hazardous waste pharmaceuticals.
266.504
Healthcare facilities that are very
small quantity generators for both
hazardous waste pharmaceuticals and
non-pharmaceutical hazardous waste.
266.505
Prohibition of sewering hazardous
waste pharmaceuticals.
266.506
Conditional exemption for
hazardous waste pharmaceuticals that
are also controlled substances and
household hazardous waste
pharmaceuticals collected in a take-back
event or program.
266.507
Residues of hazardous waste
pharmaceuticals in empty containers.
266.508
Shipping non-creditable hazardous
waste pharmaceuticals from a healthcare
facility or evaluated hazardous waste
pharmaceuticals from a reverse
distributor.
266.509
Shipping potentially creditable
hazardous waste pharmaceuticals from a
healthcare facility or a reverse distributor
to a reverse distributor.
266.510
Standards for the management of
potentially creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals at
reverse distributors.
Subpart P-Hazardous Waste
Pharmaceuticals
§
266.500
Definitions for this subpart.
The following definitions apply to
this subpart:
Evaluated hazardous waste
pharmaceutical means a prescription
hazardous waste pharmaceutical that
has been evaluated by a reverse
distributor in accordance with
§
266.510(a)(3) and will not be sent to
another reverse distributor for further
evaluation or verification of
manufacture credit.
Hazardous waste pharmaceutical
means a pharmaceutical that is a solid
waste, as defined in §
261.2, and
exhibits one or more characteristics
identified in part 261 subpart C or is
listed in part 261 subpart D. A
pharmaceutical is not a solid waste, as
defined in §
261.2, and therefore not a
hazardous waste pharmaceutical, if it is
legitimately used/reused (e.g., lawfully
donated for its intended purpose) or
reclaimed. An over-the-counter
pharmaceutical, dietary supplement, or
homeopathic drug is not a solid waste,
as defined in §
261.2, and therefore not
a hazardous waste pharmaceutical, if it
has a reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for its intended purpose)
or reclaimed.
Healthcare facility means any person
that is lawfully authorized to-
(1) Provide preventative, diagnostic,
therapeutic, rehabilitative, maintenance
or palliative care, and counseling,
service, assessment or procedure with
respect to the physical or mental
condition, or functional status, of a
human or animal or that affects the
structure or function of the human or
animal body; or
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(2) Distribute, sell, or dispense
pharmaceuticals, including over-the-
counter pharmaceuticals, dietary
supplements, homeopathic drugs, or
prescription pharmaceuticals. This
definition includes, but is not limited
to, wholesale distributors, third-party
logistics providers that serve as forward
distributors, military medical logistics
facilities, hospitals, psychiatric
hospitals, ambulatory surgical centers,
health clinics, physicians' offices,
optical and dental providers,
chiropractors, long-term care facilities,
ambulance services, pharmacies, long-
term care pharmacies, mail-order
pharmacies, retailers of
pharmaceuticals, veterinary clinics, and
veterinary hospitals. This definition
does not include pharmaceutical
manufacturers, reverse distributors, or
reverse logistics centers.
Household waste pharmaceutical
means a pharmaceutical that is a solid
waste, as defined in §
261.2, but is
excluded from being a hazardous waste
under §
261.4(b)(1).
Long-term care facility means a
licensed entity that provides assistance
with activities of daily living, including
managing and administering
pharmaceuticals to one or more
individuals at the facility. This
definition includes, but is not limited
to, hospice facilities, nursing facilities,
skilled nursing facilities, and the
nursing and skilled nursing care
portions of continuing care retirement
communities. Not included within the
scope of this definition are group
homes, independent living
communities, assisted living facilities,
and the independent and assisted living
portions of continuing care retirement
communities.
Non-creditable hazardous waste
pharmaceutical means a prescription
hazardous waste pharmaceutical that
does not have a reasonable expectation
to be eligible for manufacturer credit or
a nonprescription hazardous waste
pharmaceutical that does not have a
reasonable expectation to be
legitimately used/reused or reclaimed.
This includes but is not limited to,
investigational drugs, free samples of
pharmaceuticals received by healthcare
facilities, residues of pharmaceuticals
remaining in empty containers,
contaminated personal protective
equipment, floor sweepings, and clean-
up material from the spills of
pharmaceuticals.
Non-hazardous waste pharmaceutical
means a pharmaceutical that is a solid
waste, as defined in §
261.2, and is not
listed in 40 CFR part 261 subpart D, and
does not exhibit a characteristic
identified in 40 CFR part 261 subpart C.
Non-pharmaceutical hazardous waste
means a solid waste, as defined in
§
261.2, that is listed in 40 CFR part 261
subpart D, or exhibits one or more
characteristics identified in 40 CFR part
261 subpart C, but is not a
pharmaceutical, as defined in this
section.
Pharmaceutical means any drug or
dietary supplement for use by humans
or other animals; any electronic nicotine
delivery system (e.g., electronic cigarette
or vaping pen); or any liquid nicotine (e-
liquid) packaged for retail sale for use in
electronic nicotine delivery systems
(e.g., pre-filled cartridges or vials). This
definition includes, but is not limited
to, dietary supplements, as defined by
the Federal Food, Drug and Cosmetic
Act; prescription drugs, as defined by 21
CFR 203.3(y); over-the-counter drugs;
homeopathic drugs; compounded drugs;
investigational new drugs;
pharmaceuticals remaining in non-
empty containers; personal protective
equipment contaminated with
pharmaceuticals; and clean-up material
from spills of pharmaceuticals. This
definition does not include dental
amalgam or sharps.
Potentially creditable hazardous
waste pharmaceutical means a
prescription hazardous waste
pharmaceutical that has a reasonable
expectation to receive manufacturer
credit and is-
(1) In original manufacturer packaging
(except pharmaceuticals that were
subject to a recall);
(2) Undispensed; and
(3) Unexpired or less than one year
past expiration date. The term does not
include evaluated hazardous waste
pharmaceuticals or nonprescription
pharmaceuticals including, but not
limited to, over-the-counter drugs,
homeopathic drugs, and dietary
supplements.
Reverse distributor means any person
that receives and accumulates
prescription pharmaceuticals that are
potentially creditable hazardous waste
pharmaceuticals for the purpose of
facilitating or verifying manufacturer
credit. Any person, including forward
distributors, third-party logistics
providers, and pharmaceutical
manufacturers, that processes
prescription pharmaceuticals for the
facilitation or verification of
manufacturer credit is considered a
reverse distributor.
§
266.501
Applicability.
(a) A healthcare facility that is a very
small quantity generator when counting
all of its hazardous waste, including
both its hazardous waste
pharmaceuticals and its non-
pharmaceutical hazardous waste,
remains subject to §
262.14 and is not
subject to this subpart, except for
§§
266.505 and 266.507 and the optional
provisions of §
266.504.
(b) A healthcare facility that is a very
small quantity generator when counting
all of its hazardous waste, including
both its hazardous waste
pharmaceuticals and its non-
pharmaceutical hazardous waste, has
the option of complying with
§
266.501(d) for the management of its
hazardous waste pharmaceuticals as an
alternative to complying with §
262.14
and the optional provisions of
§
266.504.
(c) A healthcare facility or reverse
distributor remains subject to all
applicable hazardous waste regulations
with respect to the management of its
non-pharmaceutical hazardous waste.
(d) With the exception of healthcare
facilities identified in paragraph (a) of
this section, a healthcare facility is
subject to the following in lieu of parts
262 through 265:
(1) Sections 266.502 and 266.505
through 266.508 of this subpart with
respect to the management of:
(i) Non-creditable hazardous waste
pharmaceuticals, and
(ii) Potentially creditable hazardous
waste pharmaceuticals if they are not
destined for a reverse distributor.
(2) Sections 262.502(a), 266.503,
266.505 through 266.507, and 266.509
of this subpart with respect to the
management of potentially creditable
hazardous waste pharmaceuticals that
are prescription pharmaceuticals and
are destined for a reverse distributor.
(e) A reverse distributor is subject to
§§
266.505 through 266.510 of this
subpart in lieu of parts 262 through 265
with respect to the management of
hazardous waste pharmaceuticals.
(f) Hazardous waste pharmaceuticals
generated or managed by entities other
than healthcare facilities and reverse
distributors (e.g., pharmaceutical
manufacturers and reverse logistics
centers) are not subject to this subpart.
Other generators are subject to 40 CFR
part 262 for the generation and
accumulation of hazardous wastes,
including hazardous waste
pharmaceuticals.
(g) The following are not subject to 40
CFR parts 260 through 273, except as
specified:
(1) Pharmaceuticals that are not solid
waste, as defined by §
261.2, because
they are legitimately used/reused (e.g.,
lawfully donated for their intended
purpose) or reclaimed.
(2) Over-the-counter pharmaceuticals,
dietary supplements, or homeopathic
drugs that are not solid wastes, as
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defined by §
261.2, because they have a
reasonable expectation of being
legitimately used/reused (e.g., lawfully
redistributed for their intended purpose)
or reclaimed.
(3) Pharmaceuticals being managed in
accordance with a recall strategy that
has been approved by the Food and
Drug Administration in accordance with
21 CFR part 7 subpart C. This subpart
does apply to the management of the
recalled hazardous waste
pharmaceuticals after the Food and
Drug Administration approves the
destruction of the recalled items.
(4) Pharmaceuticals being managed in
accordance with a recall corrective
action plan that has been accepted by
the Consumer Product Safety
Commission in accordance with 16 CFR
part 1115. This subpart does apply to
the management of the recalled
hazardous waste pharmaceuticals after
the Consumer Product Safety
Commission approves the destruction of
the recalled items.
(5) Pharmaceuticals stored according
to a preservation order, or during an
investigation or judicial proceeding
until after the preservation order,
investigation, or judicial proceeding has
concluded and/or a decision is made to
discard the pharmaceuticals.
(6) Investigational new drugs for
which an investigational new drug
application is in effect in accordance
with the Food and Drug
Administration's regulations in 21 CFR
part 312. This subpart does apply to the
management of the investigational new
drug after the decision is made to
discard the investigational new drug or
the Food and Drug Administration
approves the destruction of the
investigational new drug, if the
investigational new drug is a hazardous
waste.
(7) Household waste pharmaceuticals,
including those that have been collected
by an authorized collector (as defined
by the Drug Enforcement
Administration), provided the
authorized collector complies with the
conditional exemption in
§§
266.506(a)(2) and 266.506(b).
§
266.502
Standards for healthcare
facilities managing non-creditable
hazardous waste pharmaceuticals.
(a) Notification and withdrawal from
this subpart for healthcare facilities
managing hazardous waste
pharmaceuticals-(1) Notification. A
healthcare facility must notify the EPA
Regional Administrator, using the Site
Identification Form (EPA Form 8700-
12), that it is a healthcare facility
operating under this subpart. A
healthcare facility is not required to fill
out Box 10.B. (Waste Codes for
Federally Regulated Hazardous Waste)
of the Site Identification Form with
respect to its hazardous waste
pharmaceuticals. A healthcare facility
must submit a separate notification (Site
Identification Form) for each site or EPA
identification number.
(i) A healthcare facility that already
has an EPA identification number must
notify the EPA Regional Administrator,
using the Site Identification Form (EPA
Form 8700-12), that it is a healthcare
facility as part of its next Biennial
Report, if it is required to submit one;
or if not required to submit a Biennial
Report, within 60 days of the effective
date of this subpart, or within 60 days
of becoming subject to this subpart.
(ii) A healthcare facility that does not
have an EPA identification number
must obtain one by notifying the EPA
Regional Administrator, using the Site
Identification Form (EPA Form 8700-
12), that it is a healthcare facility as part
of its next Biennial Report, if it is
required to submit one; or if not
required to submit a Biennial Report,
within 60 days of the effective date of
this subpart, or within 60 days of
becoming subject to this subpart.
(iii) A healthcare facility must keep a
copy of its notification on file for as long
as the healthcare facility is subject to
this subpart.
(2) Withdrawal. A healthcare facility
that operated under this subpart but is
no longer subject to this subpart,
because it is a very small quantity
generator under §
262.14, and elects to
withdraw from this subpart, must notify
the appropriate EPA Regional
Administrator using the Site
Identification Form (EPA Form 8700-
12) that it is no longer operating under
this subpart. A healthcare facility is not
required to fill out Box 10.B. (Waste
Codes for Federally Regulated
Hazardous Waste) of the Site
Identification Form with respect to its
hazardous waste pharmaceuticals. A
healthcare facility must submit a
separate notification (Site Identification
Form) for each EPA identification
number.
(i) A healthcare facility must submit
the Site Identification Form notifying
that it is withdrawing from this subpart
before it begins operating under the
conditional exemption of §
262.14.
(ii) A healthcare facility must keep a
copy of its withdrawal on file for three
years from the date of signature on the
notification of its withdrawal.
(b) Training of personnel managing
non-creditable hazardous waste
pharmaceuticals at healthcare facilities.
A healthcare facility must ensure that
all personnel that manage non-
creditable hazardous waste
pharmaceuticals are thoroughly familiar
with proper waste handling and
emergency procedures relevant to their
responsibilities during normal facility
operations and emergencies.
(c) Hazardous waste determination for
non-creditable pharmaceuticals. A
healthcare facility that generates a solid
waste that is a non-creditable
pharmaceutical must determine whether
that pharmaceutical is a hazardous
waste pharmaceutical (i.e., it exhibits a
characteristic identified in 40 CFR part
261 subpart C or is listed in 40 CFR part
261 subpart D) in order to determine
whether the waste is subject to this
subpart. A healthcare facility may
choose to manage its non-hazardous
waste pharmaceuticals as non-creditable
hazardous waste pharmaceuticals under
this subpart.
(d) Standards for containers used to
accumulate non-creditable hazardous
waste pharmaceuticals at healthcare
facilities. (1) A healthcare facility must
place non-creditable hazardous waste
pharmaceuticals in a container that is
structurally sound, compatible with its
contents, and that lacks evidence of
leakage, spillage, or damage that could
cause leakage under reasonably
foreseeable conditions.
(2) A healthcare facility that manages
ignitable or reactive non-creditable
hazardous waste pharmaceuticals, or
that mixes or commingles incompatible
non-creditable hazardous waste
pharmaceuticals must manage the
container so that it does not have the
potential to:
(i) Generate extreme heat or pressure,
fire or explosion, or violent reaction;
(ii) Produce uncontrolled toxic mists,
fumes, dusts, or gases in sufficient
quantities to threaten human health;
(iii) Produce uncontrolled flammable
fumes or gases in sufficient quantities to
pose a risk of fire or explosions;
(iv) Damage the structural integrity of
the container of non-creditable
hazardous waste pharmaceuticals; or
(v) Through other like means threaten
human health or the environment.
(3) A healthcare facility must keep
containers of non-creditable hazardous
waste pharmaceuticals closed and
secured in a manner that prevents
unauthorized access to its contents.
(4) A healthcare facility may
accumulate non-creditable hazardous
waste pharmaceuticals and non-
hazardous non-creditable waste
pharmaceuticals in the same container,
except that non-creditable hazardous
waste pharmaceuticals prohibited from
being combusted because of the dilution
prohibition of §
268.3(c) must be
accumulated in separate containers and
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labeled with all applicable hazardous
waste numbers (i.e., hazardous waste
codes).
(e) Labeling containers used to
accumulate non-creditable hazardous
waste pharmaceuticals at healthcare
facilities. A healthcare facility must
label or clearly mark each container of
non-creditable hazardous waste
pharmaceuticals with the phrase
''Hazardous Waste Pharmaceuticals.''
(f) Maximum accumulation time for
non-creditable hazardous waste
pharmaceuticals at healthcare facilities.
(1) A healthcare facility may accumulate
non-creditable hazardous waste
pharmaceuticals on site for one year or
less without a permit or having interim
status.
(2) A healthcare facility that
accumulates non-creditable hazardous
waste pharmaceuticals on-site must
demonstrate the length of time that the
non-creditable hazardous waste
pharmaceuticals have been
accumulating, starting from the date it
first becomes a waste. A healthcare
facility may make this demonstration by
any of the following methods:
(i) Marking or labeling the container
of non-creditable hazardous waste
pharmaceuticals with the date that the
non-creditable hazardous waste
pharmaceuticals became a waste;
(ii) Maintaining an inventory system
that identifies the date the non-
creditable hazardous waste
pharmaceuticals being accumulated first
became a waste;
(iii) Placing the non-creditable
hazardous waste pharmaceuticals in a
specific area and identifying the earliest
date that any of the non-creditable
hazardous waste pharmaceuticals in the
area became a waste.
(g) Land disposal restrictions for non-
creditable hazardous waste
pharmaceuticals. The non-creditable
hazardous waste pharmaceuticals
generated by a healthcare facility are
subject to the land disposal restrictions
of 40 CFR part 268. A healthcare facility
that generates non-creditable hazardous
waste pharmaceuticals must comply
with the land disposal restrictions in
accordance with §
268.7(a)
requirements, except that it is not
required to identify the hazardous waste
numbers (i.e., hazardous waste codes)
on the land disposal restrictions
notification.
(h) Procedures for healthcare facilities
for managing rejected shipments of non-
creditable hazardous waste
pharmaceuticals. A healthcare facility
that sends a shipment of non-creditable
hazardous waste pharmaceuticals to a
designated facility with the
understanding that the designated
facility can accept and manage the
waste, and later receives that shipment
back as a rejected load in accordance
with the manifest discrepancy
provisions of §
264.72 or §
265.72 of this
chapter may accumulate the returned
non-creditable hazardous waste
pharmaceuticals on site for up to an
additional 90 days provided the rejected
or returned shipment is managed in
accordance with paragraphs (d) and (e)
of this section. Upon receipt of the
returned shipment, the healthcare
facility must:
(1) Sign either:
(i) Item 18c of the original manifest,
if the original manifest was used for the
returned shipment; or
(ii) Item 20 of the new manifest, if a
new manifest was used for the returned
shipment;
(2) Provide the transporter a copy of
the manifest;
(3) Within 30 days of receipt of the
rejected shipment, send a copy of the
manifest to the designated facility that
returned the shipment to the healthcare
facility; and
(4) Within 90 days of receipt of the
rejected shipment, transport or offer for
transport the returned shipment in
accordance with the shipping standards
of §
266.508(a).
(i) Reporting by healthcare facilities
for non-creditable hazardous waste
pharmaceuticals-(1) Biennial reporting
by healthcare facilities. Healthcare
facilities are not subject to biennial
reporting requirements under §
262.41,
with respect to non-creditable
hazardous waste pharmaceuticals
managed under this subpart.
(2) Exception reporting by healthcare
facilities for a missing copy of the
manifest-(i) For shipments from a
healthcare facility to a designated
facility. (A) If a healthcare facility does
not receive a copy of the manifest with
the signature of the owner or operator of
the designated facility within 60 days of
the date the non-creditable hazardous
waste pharmaceuticals were accepted by
the initial transporter, the healthcare
facility must submit:
(1) A legible copy of the original
manifest, indicating that the healthcare
facility has not received confirmation of
delivery, to the EPA Regional
Administrator for the Region in which
the healthcare facility is located; and
(2) A handwritten or typed note on
the manifest itself, or on an attached
sheet of paper, stating that the return
copy was not received and explaining
the efforts taken to locate the non-
creditable hazardous waste
pharmaceuticals and the results of those
efforts.
(B) [Reserved]
(ii) For shipments rejected by the
designated facility and shipped to an
alternate facility. (A) If a healthcare
facility does not receive a copy of the
manifest for a rejected shipment of the
non-creditable hazardous waste
pharmaceuticals that is forwarded by
the designated facility to an alternate
facility (using appropriate manifest
procedures), with the signature of the
owner or operator of the alternate
facility, within 60 days of the date the
non-creditable hazardous waste was
accepted by the initial transporter
forwarding the shipment of non-
creditable hazardous waste
pharmaceuticals from the designated
facility to the alternate facility, the
healthcare facility must submit:
(1) A legible copy of the original
manifest, indicating that the healthcare
facility has not received confirmation of
delivery, to the EPA Regional
Administrator for the Region in which
the healthcare facility is located; and
(2) A handwritten or typed note on
the manifest itself, or on an attached
sheet of paper, stating that the return
copy was not received and explaining
the efforts taken to locate the non-
creditable hazardous waste
pharmaceuticals and the results of those
efforts.
(B) [Reserved]
(3) Additional reports. The EPA
Regional Administrator may require
healthcare facilities to furnish
additional reports concerning the
quantities and disposition of non-
creditable hazardous waste
pharmaceuticals.
(j) Recordkeeping by healthcare
facilities for non-creditable hazardous
waste pharmaceuticals. (1) A healthcare
facility must keep a copy of each
manifest signed in accordance with
§
262.23(a) for three years or until it
receives a signed copy from the
designated facility which received the
non-creditable hazardous waste
pharmaceuticals. This signed copy must
be retained as a record for at least three
years from the date the waste was
accepted by the initial transporter.
(2) A healthcare facility must keep a
copy of each exception report for a
period of at least three years from the
date of the report.
(3) A healthcare facility must keep
records of any test results, waste
analyses, or other determinations made
to support its hazardous waste
determination(s) consistent with
§
262.11(f), for at least three years from
the date the waste was last sent to on-
site or off-site treatment, storage or
disposal. A healthcare facility that
manages all of its non-creditable non-
hazardous waste pharmaceuticals as
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non-creditable hazardous waste
pharmaceuticals is not required to keep
documentation of hazardous waste
determinations.
(4) The periods of retention referred to
in this section are extended
automatically during the course of any
unresolved enforcement action
regarding the regulated activity, or as
requested by the EPA Regional
Administrator.
(5) All records must be readily
available upon request by an inspector.
(k) Response to spills of non-
creditable hazardous waste
pharmaceuticals at healthcare facilities.
A healthcare facility must immediately
contain all spills of non-creditable
hazardous waste pharmaceuticals and
manage the spill clean-up materials as
non-creditable hazardous waste
pharmaceuticals in accordance with the
requirements of this subpart.
(l) Accepting non-creditable
hazardous waste pharmaceuticals from
an off-site healthcare facility that is a
very small quantity generator. A
healthcare facility may accept non-
creditable hazardous waste
pharmaceuticals from an off-site
healthcare facility that is a very small
quantity generator under §
262.14,
without a permit or without having
interim status, provided the receiving
healthcare facility:
(1) Is under the control of the same
person (as defined in §
260.10) as the
very small quantity generator healthcare
facility that is sending the non-
creditable hazardous waste
pharmaceuticals off-site (''control,'' for
the purposes of this section, means the
power to direct the policies of the
healthcare facility, whether by the
ownership of stock, voting rights, or
otherwise, except that contractors who
operate healthcare facilities on behalf of
a different person as defined in §
260.10
of this chapter shall not be deemed to
''control'' such healthcare facilities) or
has a contractual or other documented
business relationship whereby the
receiving healthcare facility supplies
pharmaceuticals to the very small
quantity generator healthcare facility;
(2) Is operating under this subpart for
the management of its non-creditable
hazardous waste pharmaceuticals;
(3) Manages the non-creditable
hazardous waste pharmaceuticals that it
receives from off site in compliance
with this subpart; and
(4) Keeps records of the non-
creditable hazardous waste
pharmaceuticals shipments it receives
from off site for three years from the
date that the shipment is received.
§
266.503
Standards for healthcare
facilities managing potentially creditable
hazardous waste pharmaceuticals.
(a) Hazardous waste determination for
potentially creditable pharmaceuticals.
A healthcare facility that generates a
solid waste that is a potentially
creditable pharmaceutical must
determine whether the potentially
creditable pharmaceutical is a
potentially creditable hazardous waste
pharmaceutical (i.e., it is listed in 40
CFR part 261 subpart D or exhibits a
characteristic identified in 40 CFR part
261 subpart C). A healthcare facility
may choose to manage its potentially
creditable non-hazardous waste
pharmaceuticals as potentially
creditable hazardous waste
pharmaceuticals under this subpart.
(b) Accepting potentially creditable
hazardous waste pharmaceuticals from
an off-site healthcare facility that is a
very small quantity generator. A
healthcare facility may accept
potentially creditable hazardous waste
pharmaceuticals from an off-site
healthcare facility that is a very small
quantity generator under §
262.14,
without a permit or without having
interim status, provided the receiving
healthcare facility:
(1) Is under the control of the same
person, as defined in §
260.10, as the
very small quantity generator healthcare
facility that is sending the potentially
creditable hazardous waste
pharmaceuticals off site, or has a
contractual or other documented
business relationship whereby the
receiving healthcare facility supplies
pharmaceuticals to the very small
quantity generator healthcare facility;
(2) Is operating under this subpart for
the management of its potentially
creditable hazardous waste
pharmaceuticals;
(3) Manages the potentially creditable
hazardous waste pharmaceuticals that it
receives from off site in compliance
with this subpart; and
(4) Keeps records of the potentially
creditable hazardous waste
pharmaceuticals shipments it receives
from off site for three years from the
date that the shipment is received.
(c) Prohibition. Healthcare facilities
are prohibited from sending hazardous
wastes other than potentially creditable
hazardous waste pharmaceuticals to a
reverse distributor.
(d) Biennial Reporting by healthcare
facilities. Healthcare facilities are not
subject to biennial reporting
requirements under §
262.41 with
respect to potentially creditable
hazardous waste pharmaceuticals
managed under this subpart.
(e) Recordkeeping by healthcare
facilities. (1) A healthcare facility that
initiates a shipment of potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor
must keep the following records (paper
or electronic) for each shipment of
potentially creditable hazardous waste
pharmaceuticals for three years from the
date of shipment:
(i) The confirmation of delivery; and
(ii) The shipping papers prepared in
accordance with 49 CFR part 172
subpart C, if applicable.
(2) The periods of retention referred to
in this section are extended
automatically during the course of any
unresolved enforcement action
regarding the regulated activity, or as
requested by the EPA Regional
Administrator.
(3) All records must be readily
available upon request by an inspector.
(f) Response to spills of potentially
creditable hazardous waste
pharmaceuticals at healthcare facilities.
A healthcare facility must immediately
contain all spills of potentially
creditable hazardous waste
pharmaceuticals and manage the spill
clean-up materials as non-creditable
hazardous waste pharmaceuticals in
accordance with this subpart.
§
266.504
Healthcare facilities that are very
small quantity generators for both
hazardous waste pharmaceuticals and non-
pharmaceutical hazardous waste.
(a) Potentially creditable hazardous
waste pharmaceuticals. A healthcare
facility that is a very small quantity
generator for both hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste may
send its potentially creditable hazardous
waste pharmaceuticals to a reverse
distributor.
(b) Off-site collection of hazardous
waste pharmaceuticals generated by a
healthcare facility that is a very small
quantity generator. A healthcare facility
that is a very small quantity generator
for both hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste may
send its hazardous waste
pharmaceuticals off-site to another
healthcare facility, provided:
(1) The receiving healthcare facility
meets the conditions in §
266.502(l) of
this subpart and §
266.503(b), as
applicable; or
(2) The very small quantity generator
healthcare facility meets the conditions
in §
262.14(a)(5)(viii) and the receiving
large quantity generator meets the
conditions in §
262.17(f).
(c) Long-term care facilities that are
very small quantity generators. A long-
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term care facility that is a very small
quantity generator for both hazardous
waste pharmaceuticals and non-
pharmaceutical hazardous waste may
dispose of its hazardous waste
pharmaceuticals (excluding
contaminated personal protective
equipment or clean-up materials) in an
on-site collection receptacle of an
authorized collector (as defined by the
Drug Enforcement Administration) that
is registered with the Drug Enforcement
Administration provided the contents
are collected, stored, transported,
destroyed and disposed of in
compliance with all applicable Drug
Enforcement Administration regulations
for controlled substances.
(d) Long-term care facilities with 20
beds or fewer. A long-term care facility
with 20 beds or fewer is presumed to be
a very small quantity generator subject
to §
262.14 for both hazardous waste
pharmaceuticals and non-
pharmaceutical hazardous waste and
not subject to this subpart, except for
§§
266.505 and 266.507 and the other
optional provisions of this section. The
EPA Regional Administrator has the
responsibility to demonstrate that a
long-term care facility with 20 beds or
fewer generates quantities of hazardous
waste that are in excess of the very
small quantity generator limits as
defined in §
260.10. A long-term care
facility with more than 20 beds that
operates as a very small quantity
generator under §
262.14 must
demonstrate that it generates quantities
of hazardous waste that are within the
very small quantity generator limits as
defined by §
260.10.
§
266.505
Prohibition of sewering
hazardous waste pharmaceuticals.
All healthcare facilities-including
very small quantity generators operating
under §
262.14 in lieu of this subpart-
and reverse distributors are prohibited
from discharging hazardous waste
pharmaceuticals to a sewer system that
passes through to a publicly-owned
treatment works. Healthcare facilities
and reverse distributors remain subject
to the prohibitions in 40 CFR
403.5(b)(1).
§
266.506
Conditional exemptions for
hazardous waste pharmaceuticals that are
also controlled substances and household
waste pharmaceuticals collected in a take-
back event or program.
(a) Conditional exemptions. Provided
the conditions of paragraph (b) of this
section are met, the following are
exempt from 40 CFR parts 262 through
273:
(1) Hazardous waste pharmaceuticals
that are also listed on a schedule of
controlled substances by the Drug
Enforcement Administration in 21 CFR
part 1308, and
(2) Household waste pharmaceuticals
that are collected in a take-back event or
program, including those that are
collected by an authorized collector (as
defined by the Drug Enforcement
Administration) registered with the
Drug Enforcement Administration that
commingles the household waste
pharmaceuticals with controlled
substances from an ultimate user (as
defined by the Drug Enforcement
Administration).
(b) Conditions for exemption. The
hazardous waste pharmaceuticals must
be:
(1) Managed in compliance with the
sewer prohibition of §
266.505; and
(2) Collected, stored, transported, and
disposed of in compliance with all
applicable Drug Enforcement
Administration regulations for
controlled substances; and
(3) Destroyed by a method that Drug
Enforcement Administration has
publicly deemed in writing to meet their
non-retrievable standard of destruction
or combusted at one of the following:
(i) A permitted large municipal waste
combustor, subject to 40 CFR part 62
subpart FFF or applicable state plan for
existing large municipal waste
combustors, or 40 CFR part 60 subparts
Eb for new large municipal waste
combustors; or
(ii) A permitted small municipal
waste combustor, subject to 40 CFR part
62 subpart JJJ or applicable state plan for
existing small municipal waste
combustors, or 40 CFR part 60 subparts
AAAA for new small municipal waste
combustors; or
(iii) A permitted hospital, medical
and infectious waste incinerator, subject
to 40 CFR part 62 subpart HHH or
applicable state plan for existing
hospital, medical and infectious waste
incinerators, or 40 CFR part 60 subpart
Ec for new hospital, medical and
infectious waste incinerators.
(iv) A permitted commercial and
industrial solid waste incinerator,
subject to 40 CFR part 62 subpart III or
applicable state plan for existing
commercial and industrial solid waste
incinerators, or 40 CFR part 60 subpart
CCCC for new commercial and
industrial solid waste incinerators.
(v) A permitted hazardous waste
combustor subject to 40 CFR part 63
subpart EEE.
§
266.507
Residues of hazardous waste
pharmaceuticals in empty containers.
(a) Stock, dispensing and unit-dose
containers. A stock bottle, dispensing
bottle, vial, or ampule (not to exceed 1
liter or 10,000 pills); or a unit-dose
container (e.g., a unit-dose packet, cup,
wrapper, blister pack, or delivery
device) is considered empty and the
residues are not regulated as hazardous
waste provided the pharmaceuticals
have been removed from the stock
bottle, dispensing bottle, vial, ampule,
or the unit-dose container using the
practices commonly employed to
remove materials from that type of
container.
(b) Syringes. A syringe is considered
empty and the residues are not
regulated as hazardous waste under this
subpart provided the contents have been
removed by fully depressing the plunger
of the syringe. If a syringe is not empty,
the syringe must be placed with its
remaining hazardous waste
pharmaceuticals into a container that is
managed and disposed of as a non-
creditable hazardous waste
pharmaceutical under this subpart and
any applicable federal, state, and local
requirements for sharps containers and
medical waste.
(c) Intravenous (IV) bags. An IV bag is
considered empty and the residues are
not regulated as hazardous waste
provided the pharmaceuticals in the IV
bag have been fully administered to a
patient. If an IV bag is not empty, the
IV bag must be placed with its
remaining hazardous waste
pharmaceuticals into a container that is
managed and disposed of as a non-
creditable hazardous waste
pharmaceutical under this subpart,
unless the IV bag held non-acute
hazardous waste pharmaceuticals and is
empty as defined in §
261.7(b)(1).
(d) Other containers, including
delivery devices. Hazardous waste
pharmaceuticals remaining in all other
types of unused, partially administered,
or fully administered containers must be
managed as non-creditable hazardous
waste pharmaceuticals under this
subpart, unless the container held non-
acute hazardous waste pharmaceuticals
and is empty as defined in §
261.7(b)(1)
or (2). This includes, but is not limited
to, residues in inhalers, aerosol cans,
nebulizers, tubes of ointments, gels, or
creams.
§
266.508
Shipping non-creditable
hazardous waste pharmaceuticals from a
healthcare facility or evaluated hazardous
waste pharmaceuticals from a reverse
distributor.
(a) Shipping non-creditable
hazardous waste pharmaceuticals or
evaluated hazardous waste
pharmaceuticals. A healthcare facility
must ship non-creditable hazardous
waste pharmaceuticals and a reverse
distributor must ship evaluated
hazardous waste pharmaceuticals off-
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site to a designated facility (such as a
permitted or interim status treatment,
storage, or disposal facility) in
compliance with:
(1) The following pre-transport
requirements, before transporting or
offering for transport off-site:
(i) Packaging. Package the waste in
accordance with the applicable
Department of Transportation
regulations on hazardous materials
under 49 CFR parts 173, 178, and 180.
(ii) Labeling. Label each package in
accordance with the applicable
Department of Transportation
regulations on hazardous materials
under 49 CFR part 172 subpart E.
(iii) Marking. (A) Mark each package
of hazardous waste pharmaceuticals in
accordance with the applicable
Department of Transportation (DOT)
regulations on hazardous materials
under 49 CFR part 172 subpart D;
(B) Mark each container of 119 gallons
or less used in such transportation with
the following words and information in
accordance with the requirements of 49
CFR 172.304:
HAZARDOUS WASTE-Federal Law
Prohibits Improper Disposal. If found,
contact the nearest police or public
safety authority or the U.S.
Environmental Protection Agency.
Healthcare Facility's or Reverse distributor's
Name and Address llllllllllll
Healthcare Facility's or Reverse distributor's
EPA Identification Number llllllll
Manifest Tracking Number llllllll
(C) Lab packs that will be incinerated
in compliance with §
268.42(c) are not
required to be marked with EPA
Hazardous Waste Number(s), except
D004, D005, D006, D007, D008, D010,
and D011, where applicable. A
nationally recognized electronic system,
such as bar coding or radio frequency
identification, may be used to identify
the EPA Hazardous Waste Number(s).
(iv) Placarding. Placard or offer the
initial transporter the appropriate
placards according to Department of
Transportation regulations for
hazardous materials under 49 CFR part
172 subpart F.
(2) The manifest requirements of 40
CFR part 262 subpart B, except that:
(i) A healthcare facility shipping non-
creditable hazardous waste
pharmaceuticals is not required to list
all applicable hazardous waste numbers
(i.e., hazardous waste codes) in Item 13
of EPA Form 8700-22.
(ii) A healthcare facility shipping non-
creditable hazardous waste
pharmaceuticals must write the word
''PHARMS'' in Item 13 of EPA Form
8700-22.
(b) Exporting non-creditable
hazardous waste pharmaceuticals or
evaluated hazardous waste
pharmaceuticals. A healthcare facility
or reverse distributor that exports non-
creditable hazardous waste
pharmaceuticals or evaluated hazardous
waste pharmaceuticals is subject to 40
CFR part 262 subpart H.
(c) Importing non-creditable
hazardous waste pharmaceuticals or
evaluated hazardous waste
pharmaceuticals. Any person that
imports non-creditable hazardous waste
pharmaceuticals or evaluated hazardous
waste pharmaceuticals is subject to 40
CFR part 262 subpart H. A healthcare
facility or reverse distributor may not
accept imported non-creditable
hazardous waste pharmaceuticals or
evaluated hazardous waste
pharmaceuticals unless they have a
permit or interim status that allows
them to accept hazardous waste from off
site.
§
266.509
Shipping potentially creditable
hazardous waste pharmaceuticals from a
healthcare facility or a reverse distributor to
a reverse distributor.
(a) Shipping potentially creditable
hazardous waste pharmaceuticals. A
healthcare facility or a reverse
distributor who transports or offers for
transport potentially creditable
hazardous waste pharmaceuticals off-
site to a reverse distributor must comply
with all applicable U.S. Department of
Transportation regulations in 49 CFR
part 171 through 180 for any potentially
creditable hazardous waste
pharmaceutical that meets the definition
of hazardous material in 49 CFR 171.8.
For purposes of the Department of
Transportation regulations, a material is
considered a hazardous waste if it is
subject to the Hazardous Waste Manifest
Requirements of the U.S. Environmental
Protection Agency specified in 40 CFR
part 262. Because a potentially
creditable hazardous waste
pharmaceutical does not require a
manifest, it is not considered hazardous
waste under the Department of
Transportation regulations.
(b) Delivery confirmation. Upon
receipt of each shipment of potentially
creditable hazardous waste
pharmaceuticals, the receiving reverse
distributor must provide confirmation
(paper or electronic) to the healthcare
facility or reverse distributor that
initiated the shipment that the shipment
of potentially creditable hazardous
waste pharmaceuticals has arrived at its
destination and is under the custody
and control of the reverse distributor.
(c) Procedures for when delivery
confirmation is not received within 35
calendar days. If a healthcare facility or
reverse distributor initiates a shipment
of potentially creditable hazardous
waste pharmaceuticals to a reverse
distributor and does not receive delivery
confirmation within 35 calendar days
from the date that the shipment of
potentially creditable hazardous waste
pharmaceuticals was sent, the
healthcare facility or reverse distributor
that initiated the shipment must contact
the carrier and the intended recipient
(i.e., the reverse distributor) promptly to
report that the delivery confirmation
was not received and to determine the
status of the potentially creditable
hazardous waste pharmaceuticals.
(d) Exporting potentially creditable
hazardous waste pharmaceuticals. A
healthcare facility or reverse distributor
that sends potentially creditable
hazardous waste pharmaceuticals to a
foreign destination must comply with
the applicable sections of 40 CFR part
262 subpart H, except the manifesting
requirement of §
262.83(c), in addition
to paragraphs (a) through (c) of this
section.
(e) Importing potentially creditable
hazardous waste pharmaceuticals. Any
person that imports potentially
creditable hazardous waste
pharmaceuticals into the United States
is subject to paragraphs (a) through (c)
of this section in lieu of 40 CFR part 262
subpart H. Immediately after the
potentially creditable hazardous waste
pharmaceuticals enter the United States,
they are subject to all applicable
requirements of this subpart.
§
266.510
Standards for the management
of potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous
waste pharmaceuticals at reverse
distributors.
A reverse distributor may accept
potentially creditable hazardous waste
pharmaceuticals from off site and
accumulate potentially creditable
hazardous waste pharmaceuticals or
evaluated hazardous waste
pharmaceuticals on site without a
hazardous waste permit or without
having interim status, provided that it
complies with the following conditions:
(a) Standards for reverse distributors
managing potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals-(1) Notification. A
reverse distributor must notify the EPA
Regional Administrator, using the Site
Identification Form (EPA Form 8700-
12), that it is a reverse distributor
operating under this subpart.
(i) A reverse distributor that already
has an EPA identification number must
notify the EPA Regional Administrator,
using the Site Identification Form (EPA
Form 8700-12), that it is a reverse
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distributor, as defined in §
266.500,
within 60 days of the effective date of
this subpart, or within 60 days of
becoming subject to this subpart.
(ii) A reverse distributor that does not
have an EPA identification number
must obtain one by notifying the EPA
Regional Administrator, using the Site
Identification Form (EPA Form 8700-
12), that it is a reverse distributor, as
defined in §
266.500, within 60 days of
the effective date of this subpart, or
within 60 days of becoming subject to
this subpart.
(2) Inventory by the reverse
distributor. A reverse distributor must
maintain a current inventory of all the
potentially creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals that
are accumulated on site.
(i) A reverse distributor must
inventory each potentially creditable
hazardous waste pharmaceutical within
30 calendar days of each waste arriving
at the reverse distributor.
(ii) The inventory must include the
identity (e.g., name or national drug
code) and quantity of each potentially
creditable hazardous waste
pharmaceutical and evaluated
hazardous waste pharmaceutical.
(iii) If the reverse distributor already
meets the inventory requirements of this
paragraph because of other regulatory
requirements, such as State Board of
Pharmacy regulations, the facility is not
required to provide a separate inventory
pursuant to this section.
(3) Evaluation by a reverse distributor
that is not a manufacturer. A reverse
distributor that is not a pharmaceutical
manufacturer must evaluate a
potentially creditable hazardous waste
pharmaceutical within 30 calendar days
of the waste arriving at the reverse
distributor to establish whether it is
destined for another reverse distributor
for further evaluation or verification of
manufacturer credit or for a permitted or
interim status treatment, storage, or
disposal facility.
(i) A potentially creditable hazardous
waste pharmaceutical that is destined
for another reverse distributor is still
considered a ''potentially creditable
hazardous waste pharmaceutical'' and
must be managed in accordance with
paragraph (b) of this section.
(ii) A potentially creditable hazardous
waste pharmaceutical that is destined
for a permitted or interim status
treatment, storage or disposal facility is
considered an ''evaluated hazardous
waste pharmaceutical'' and must be
managed in accordance with paragraph
(c) of this section.
(4) Evaluation by a reverse distributor
that is a manufacturer. A reverse
distributor that is a pharmaceutical
manufacturer must evaluate a
potentially creditable hazardous waste
pharmaceutical to verify manufacturer
credit within 30 calendar days of the
waste arriving at the facility and
following the evaluation must manage
the evaluated hazardous waste
pharmaceuticals in accordance with
paragraph (c) of this section.
(5) Maximum accumulation time for
hazardous waste pharmaceuticals at a
reverse distributor. (i) A reverse
distributor may accumulate potentially
creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals on
site for 180 calendar days or less. The
180 days start after the potentially
creditable hazardous waste
pharmaceutical has been evaluated and
applies to all hazardous waste
pharmaceuticals accumulated on site,
regardless of whether they are destined
for another reverse distributor (i.e.,
potentially creditable hazardous waste
pharmaceuticals) or a permitted or
interim status treatment, storage, or
disposal facility (i.e., evaluated
hazardous waste pharmaceuticals).
(ii) Aging pharmaceuticals.
Unexpired pharmaceuticals that are
otherwise creditable but are awaiting
their expiration date (i.e., aging in a
holding morgue) can be accumulated for
up to 180 days after the expiration date,
provided that the unexpired
pharmaceuticals are managed in
accordance with paragraph (a) of this
section and the container labeling and
management standards in
266.510(c)(4)(i) through (vi).
(6) Security at the reverse distributor
facility. A reverse distributor must
prevent unknowing entry and minimize
the possibility for the unauthorized
entry into the portion of the facility
where potentially creditable hazardous
waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals are
kept.
(i) Examples of methods that may be
used to prevent unknowing entry and
minimize the possibility for
unauthorized entry include, but are not
limited to:
(A) A 24-hour continuous monitoring
surveillance system;
(B) An artificial barrier such as a
fence; or
(C) A means to control entry, such as
keycard access.
(ii) If the reverse distributor already
meets the security requirements of this
paragraph because of other regulatory
requirements, such as Drug Enforcement
Administration or State Board of
Pharmacy regulations, the facility is not
required to provide separate security
measures pursuant to this section.
(7) Contingency plan and emergency
procedures at a reverse distributor. A
reverse distributor that accepts
potentially creditable hazardous waste
pharmaceuticals from off site must
prepare a contingency plan and comply
with the other requirements of 40 CFR
part 262 subpart M.
(8) Closure of a reverse distributor.
When closing an area where a reverse
distributor accumulates potentially
creditable hazardous waste
pharmaceuticals or evaluated hazardous
waste pharmaceuticals, the reverse
distributor must comply with
§
262.17(a)(8)(ii) and (iii).
(9) Reporting by a reverse
distributor-(i) Unauthorized waste
report. A reverse distributor must
submit an unauthorized waste report if
the reverse distributor receives waste
from off site that it is not authorized to
receive (e.g., non-pharmaceutical
hazardous waste, regulated medical
waste). The reverse distributor must
prepare and submit an unauthorized
waste report to the EPA Regional
Administrator within 45 calendar days
after the unauthorized waste arrives at
the reverse distributor and must send a
copy of the unauthorized waste report to
the healthcare facility (or other entity)
that sent the unauthorized waste. The
reverse distributor must manage the
unauthorized waste in accordance with
all applicable regulations. The
unauthorized waste report must be
signed by the owner or operator of the
reverse distributor, or its authorized
representative, and contain the
following information:
(A) The EPA identification number,
name and address of the reverse
distributor;
(B) The date the reverse distributor
received the unauthorized waste;
(C) The EPA identification number,
name, and address of the healthcare
facility that shipped the unauthorized
waste, if available;
(D) A description and the quantity of
each unauthorized waste the reverse
distributor received;
(E) The method of treatment, storage,
or disposal for each unauthorized waste;
and
(F) A brief explanation of why the
waste was unauthorized, if known.
(ii) Additional reports. The EPA
Regional Administrator may require
reverse distributors to furnish additional
reports concerning the quantities and
disposition of potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals.
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(10) Recordkeeping by reverse
distributors. A reverse distributor must
keep the following records (paper or
electronic) readily available upon
request by an inspector. The periods of
retention referred to in this section are
extended automatically during the
course of any unresolved enforcement
action regarding the regulated activity,
or as requested by the EPA Regional
Administrator.
(i) A copy of its notification on file for
as long as the facility is subject to this
subpart;
(ii) A copy of the delivery
confirmation and the shipping papers
for each shipment of potentially
creditable hazardous waste
pharmaceuticals that it receives, and a
copy of each unauthorized waste report,
for at least three years from the date the
shipment arrives at the reverse
distributor;
(iii) A copy of its current inventory for
as long as the facility is subject to this
subpart.
(b) Additional standards for reverse
distributors managing potentially
creditable hazardous waste
pharmaceuticals destined for another
reverse distributor. A reverse distributor
that does not have a permit or interim
status must comply with the following
conditions, in addition to the
requirements in paragraph (a) of this
section, for the management of
potentially creditable hazardous waste
pharmaceuticals that are destined for
another reverse distributor for further
evaluation or verification of
manufacturer credit:
(1) A reverse distributor that receives
potentially creditable hazardous waste
pharmaceuticals from a healthcare
facility must send those potentially
creditable hazardous waste
pharmaceuticals to another reverse
distributor within 180 days after the
potentially creditable hazardous waste
pharmaceuticals have been evaluated or
follow paragraph (c) of this section for
evaluated hazardous waste
pharmaceuticals.
(2) A reverse distributor that receives
potentially creditable hazardous waste
pharmaceuticals from another reverse
distributor must send those potentially
creditable hazardous waste
pharmaceuticals to a reverse distributor
that is a pharmaceutical manufacturer
within 180 days after the potentially
creditable hazardous waste
pharmaceuticals have been evaluated or
follow paragraph (c) of this section for
evaluated hazardous waste
pharmaceuticals.
(3) A reverse distributor must ship
potentially creditable hazardous waste
pharmaceuticals destined for another
reverse distributor in accordance with
§
266.509.
(4) Recordkeeping by reverse
distributors. A reverse distributor must
keep the following records (paper or
electronic) readily available upon
request by an inspector for each
shipment of potentially creditable
hazardous waste pharmaceuticals that it
initiates to another reverse distributor,
for at least three years from the date of
shipment. The periods of retention
referred to in this section are extended
automatically during the course of any
unresolved enforcement action
regarding the regulated activity, or as
requested by the EPA Regional
Administrator.
(i) The confirmation of delivery; and
(ii) The DOT shipping papers
prepared in accordance with 49 CFR
part 172 subpart C, if applicable
(c) Additional standards for reverse
distributors managing evaluated
hazardous waste pharmaceuticals. A
reverse distributor that does not have a
permit or interim status must comply
with the following conditions, in
addition to the requirements of
paragraph (a) of this section, for the
management of evaluated hazardous
waste pharmaceuticals:
(1) Accumulation area at the reverse
distributor. A reverse distributor must
designate an on-site accumulation area
where it will accumulate evaluated
hazardous waste pharmaceuticals.
(2) Inspections of on-site
accumulation area. A reverse distributor
must inspect its on-site accumulation
area at least once every seven days,
looking at containers for leaks and for
deterioration caused by corrosion or
other factors, as well as for signs of
diversion.
(3) Personnel training at a reverse
distributor. Personnel at a reverse
distributor that handle evaluated
hazardous waste pharmaceuticals are
subject to the training requirements of
§
262.17(a)(7).
(4) Labeling and management of
containers at on-site accumulation
areas. A reverse distributor
accumulating evaluated hazardous
waste pharmaceuticals in containers in
an on-site accumulation area must:
(i) Label the containers with the
words, ''hazardous waste
pharmaceuticals'';
(ii) Ensure the containers are in good
condition and managed to prevent leaks;
(iii) Use containers that are made of
or lined with materials which will not
react with, and are otherwise
compatible with, the evaluated
hazardous waste pharmaceuticals, so
that the ability of the container to
contain the waste is not impaired;
(iv) Keep containers closed, if holding
liquid or gel evaluated hazardous waste
pharmaceuticals. If the liquid or gel
evaluated hazardous waste
pharmaceuticals are in their original,
intact, sealed packaging; or repackaged,
intact, sealed packaging, they are
considered to meet the closed container
standard;
(v) Manage any container of ignitable
or reactive evaluated hazardous waste
pharmaceuticals, or any container of
commingled incompatible evaluated
hazardous waste pharmaceuticals so
that the container does not have the
potential to:
(A) Generate extreme heat or pressure,
fire or explosion, or violent reaction;
(B) Produce uncontrolled toxic mists,
fumes, dusts, or gases in sufficient
quantities to threaten human health;
(C) Produce uncontrolled flammable
fumes or gases in sufficient quantities to
pose a risk of fire or explosions;
(D) Damage the structural integrity of
the container of hazardous waste
pharmaceuticals; or
(E) Through other like means threaten
human health or the environment; and
(vi) Accumulate evaluated hazardous
waste pharmaceuticals that are
prohibited from being combusted
because of the dilution prohibition of
§
268.3(c) (e.g., arsenic trioxide (P012))
in separate containers from other
evaluated hazardous waste
pharmaceuticals at the reverse
distributor.
(5) Hazardous waste numbers. Prior to
shipping evaluated hazardous waste
pharmaceuticals off site, all containers
must be marked with the applicable
hazardous waste numbers (i.e.,
hazardous waste codes). A nationally
recognized electronic system, such as
bar coding or radio frequency
identification, may be used to identify
the EPA Hazardous Waste Number(s).
(6) Shipments. A reverse distributor
must ship evaluated hazardous waste
pharmaceuticals that are destined for a
permitted or interim status treatment,
storage or disposal facility in
accordance with the applicable shipping
standards in §
266.508(a) or (b).
(7) Procedures for a reverse distributor
for managing rejected shipments. A
reverse distributor that sends a
shipment of evaluated hazardous waste
pharmaceuticals to a designated facility
with the understanding that the
designated facility can accept and
manage the waste, and later receives
that shipment back as a rejected load in
accordance with the manifest
discrepancy provisions of §
264.72 or
§
265.72 of this chapter, may
accumulate the returned evaluated
hazardous waste pharmaceuticals on
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site for up to an additional 90 days in
the on-site accumulation area provided
the rejected or returned shipment is
managed in accordance with
§
266.510(a) and (c). Upon receipt of the
returned shipment, the reverse
distributor must:
(i) Sign either:
(A) Item 18c of the original manifest,
if the original manifest was used for the
returned shipment; or
(B) Item 20 of the new manifest, if a
new manifest was used for the returned
shipment;
(ii) Provide the transporter a copy of
the manifest;
(iii) Within 30 days of receipt of the
rejected shipment of the evaluated
hazardous waste pharmaceuticals, send
a copy of the manifest to the designated
facility that returned the shipment to
the reverse distributor; and
(iv) Within 90 days of receipt of the
rejected shipment, transport or offer for
transport the returned shipment of
evaluated hazardous waste
pharmaceuticals in accordance with the
applicable shipping standards of
§
266.508(a) or (b).
(8) Land disposal restrictions.
Evaluated hazardous waste
pharmaceuticals are subject to the land
disposal restrictions of 40 CFR part 268.
A reverse distributor that accepts
potentially creditable hazardous waste
pharmaceuticals from off site must
comply with the land disposal
restrictions in accordance with
§
268.7(a) requirements.
(9) Reporting by a reverse distributor
for evaluated hazardous waste
pharmaceuticals-(i) Biennial reporting
by a reverse distributor. A reverse
distributor that ships evaluated
hazardous waste pharmaceuticals off-
site must prepare and submit a single
copy of a biennial report to the EPA
Regional Administrator by March 1 of
each even numbered year in accordance
with §
262.41.
(ii) Exception reporting by a reverse
distributor for a missing copy of the
manifest.
(A) For shipments from a reverse
distributor to a designated facility. (1) If
a reverse distributor does not receive a
copy of the manifest with the signature
of the owner or operator of the
designated facility within 35 days of the
date the evaluated hazardous waste
pharmaceuticals were accepted by the
initial transporter, the reverse
distributor must contact the transporter
or the owner or operator of the
designated facility to determine the
status of the evaluated hazardous waste
pharmaceuticals.
(2) A reverse distributor must submit
an exception report to the EPA Regional
Administrator for the Region in which
the reverse distributor is located if it has
not received a copy of the manifest with
the signature of the owner or operator of
the designated facility within 45 days of
the date the evaluated hazardous waste
pharmaceutical was accepted by the
initial transporter. The exception report
must include:
(i) A legible copy of the manifest for
which the reverse distributor does not
have confirmation of delivery; and
(ii) A cover letter signed by the
reverse distributor, or its authorized
representative, explaining the efforts
taken to locate the evaluated hazardous
waste pharmaceuticals and the results of
those efforts.
(B) For shipments rejected by the
designated facility and shipped to an
alternate facility. (1) A reverse
distributor that does not receive a copy
of the manifest with the signature of the
owner or operator of the alternate
facility within 35 days of the date the
evaluated hazardous waste
pharmaceuticals were accepted by the
initial transporter must contact the
transporter or the owner or operator of
the alternate facility to determine the
status of the hazardous waste. The 35-
day time frame begins the date the
evaluated hazardous waste
pharmaceuticals are accepted by the
transporter forwarding the hazardous
waste shipment from the designated
facility to the alternate facility.
(2) A reverse distributor must submit
an Exception Report to the EPA
Regional Administrator for the Region
in which the reverse distributor is
located if it has not received a copy of
the manifest with the signature of the
owner or operator of the alternate
facility within 45 days of the date the
evaluated hazardous waste
pharmaceuticals were accepted by the
initial transporter. The 45-day
timeframe begins the date the evaluated
hazardous waste pharmaceuticals are
accepted by the transporter forwarding
the hazardous waste pharmaceutical
shipment from the designated facility to
the alternate facility. The Exception
Report must include:
(i) A legible copy of the manifest for
which the generator does not have
confirmation of delivery; and
(ii) A cover letter signed by the
reverse distributor, or its authorized
representative, explaining the efforts
taken to locate the evaluated hazardous
waste pharmaceuticals and the results of
those efforts.
(10) Recordkeeping by a reverse
distributor for evaluated hazardous
waste pharmaceuticals. (i) A reverse
distributor must keep a log (written or
electronic) of the inspections of the on-
site accumulation area, required by
paragraph (c)(2) of this section. This log
must be retained as a record for at least
three years from the date of the
inspection.
(ii) A reverse distributor must keep a
copy of each manifest signed in
accordance with §
262.23(a) for three
years or until it receives a signed copy
from the designated facility that
received the evaluated hazardous waste
pharmaceutical. This signed copy must
be retained as a record for at least three
years from the date the evaluated
hazardous waste pharmaceutical was
accepted by the initial transporter.
(iii) A reverse distributor must keep a
copy of each biennial report for at least
three years from the due date of the
report.
(iv) A reverse distributor must keep a
copy of each exception report for at least
three years from the submission of the
report.
(v) A reverse distributor must keep
records to document personnel training,
in accordance with §
262.17(a)(7)(iv).
(vi) All records must be readily
available upon request by an inspector.
The periods of retention referred to in
this section are extended automatically
during the course of any unresolved
enforcement action regarding the
regulated activity, or as requested by the
EPA Regional Administrator.
(d) When a reverse distributor must
have a permit. A reverse distributor is
an operator of a hazardous waste
treatment, storage, or disposal facility
and is subject to the requirements of 40
CFR parts 264, 265, and 267 and the
permit requirements of 40 CFR part 270,
if the reverse distributor:
(1) Does not meet the conditions of
this section;
(2) Accepts manifested hazardous
waste from off site; or
(3) Treats or disposes of hazardous
waste pharmaceuticals on site.
PART 268-LAND DISPOSAL
RESTRICTIONS
■
16. The authority citation for part 268
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921,
and 6924.
■
17. Section 268.7 is amended by
revising the section heading and the
paragraph (a) subject heading to read as
follows:
§
268.7
Testing, tracking, and
recordkeeping requirements for generators,
reverse distributors, treaters, and disposal
facilities.
(a) Requirements for generators and
reverse distributors. *
*
*
* * * * *
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■
18. Section 268.50 is amended by
adding paragraphs (a)(4) and (5) to read
as follows:
§
268.50
Prohibitions on storage of
restricted wastes.
(a) *
*
*
(4) A healthcare facility accumulates
such wastes in containers on site solely
for the purpose of the accumulation of
such quantities of hazardous waste
pharmaceuticals as necessary to
facilitate proper recovery, treatment, or
disposal and the healthcare facility
complies with the applicable
requirements in §§
266.502 and 266.503
of this chapter.
(5) A reverse distributor accumulates
such wastes in containers on site solely
for the purpose of the accumulation of
such quantities of hazardous waste
pharmaceuticals as necessary to
facilitate proper recovery, treatment, or
disposal and the reverse distributor
complies with §
266.510 of this chapter.
* * * * *
PART 270-EPA ADMINISTERED
PERMIT PROGRAMS: THE
HAZARDOUS WASTE PERMIT
PROGRAM
■
19. The authority citation for part 270
continues to read as follows:
Authority: 42 U.S.C. 6905, 6912, 6924,
6925, 6927, 6939, and 6974.
■
20. Section 270.1 is amended by
adding paragraph (c)(2)(x) to read as
follows:
§
270.1
Purpose and scope of these
regulations.
* * * * *
(c) *
*
*
(2) *
*
*
(x) Reverse distributors accumulating
potentially creditable hazardous waste
pharmaceuticals and evaluated
hazardous waste pharmaceuticals, as
defined in §
266.500. Reverse
distributors are subject to regulation
under 40 CFR part 266 subpart P for the
accumulation of potentially creditable
hazardous waste pharmaceuticals and
evaluated hazardous waste
pharmaceuticals.
* * * * *
PART 273-STANDARDS FOR
UNIVERSAL WASTE MANAGEMENT
■
21. The authority citation for part 273
continues to read as follows:
Authority: 42 U.S.C. 6922, 6923, 6924,
6925, 6930, and 6937.
■
22. Section 273.80 is amended by
revising paragraph (a) and adding
paragraph (d) to read as follows:
§
273.80
General.
(a) Except as provided in paragraph
(d) of this section, any person seeking to
add a hazardous waste or category of
hazardous waste to this part may
petition for a regulatory amendment
under this subpart and 40 CFR 260.20
and 260.23.
* * * * *
(d) Hazardous waste pharmaceuticals
are regulated by 40 CFR part 266
subpart P and may not be added as a
category of hazardous waste for
management under this part.
[FR Doc. 2019-01298 Filed 2-21-19; 8:45 am]
BILLING CODE 6560-50-P
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