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URL: | https://www.deadiversion.usdoj.gov/...istrant/rdellinger.pdf |
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Title: | EPA Comments on the Development of Safe and Effective Drug Collection and Disposal Methods |
Description: | EPA Comments on the Development of Safe and Effective Drug Collection and Disposal Methods |
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Body: | 1
EPA Comments on the Development of
Safe and Effective Drug Collection and
Disposal Methods
Robert W. Dellinger, Division Director
Materials Recovery and Waste Management Division
Office of Resource Conservation and Recovery
U.S. EPA
January 20, 2011
DEA Public Meeting
Mayflower Renaissance Hotel, Washington, DC
1
Introductory Remarks
2
. Active Pharmaceutical Ingredients (APIs) have been
found in low concentrations in the environment
potentially exposing wildlife and humans
. EPA and DEA share a common goal to protect public
health
- DEA works to prevent drug diversion to people
- EPA works to prevent drug diversion to the environment
and thus indirectly to people
. Our agencies can collaborate to prevent diversion to
both people and the environment
Introductory Remarks (Cont.)
. Our collaboration should focus on making drug
take-back programs available and easy to execute
in a safe manner
. EPA is working to stop flushing of drugs where
appropriate and drug take back programs can
help keep drugs out the environment
. EPA has awarded two grants for take-back
programs which we will discuss later and drafted
Best Management Practices for Unused
Pharmaceuticals at Health Care Facilities
3
4
Overview-EPA Recommendations
. Develop a national set of options for take-back
programs
. Ensure that collected controlled substances are
managed and disposed of in accordance with
environmental regulations
. Clarify current destruction/disposal methods and
approve additional methods
. Streamline recordkeeping requirements for take-
back programs
5
Development of Take-Back Options
. EPA encourages flexibility in the new DEA regulations to allow
for various approaches to drug take-back programs
. Providing a choice of take-back options will help communities
overcome obstacles that their geographical locales may
present or that their individual residents may experience
. Some options include but are not limited to:
- Mail-back programs
- Consumer returns to DEA registrants (including but not limited to
reverse distributors)
- Secured boxes at pharmacies and/or other locations
- Any combination of the above
. EPA awarded two successful grants to test different
approaches for prudent disposal of unwanted
pharmaceuticals
6
EPA Grant: RxMEDS
. RxMEDS -
Regional Excess Medication Disposal Service
- St. Louis Metro Region
. Returns by users to pharmacies
. Collected 244,708 capsules, tablets and suppositories
over an 12 month period
. Unable to obtain permission to collect controlled
substances
. All collected drugs were incinerated
. No instances of diversion, theft, etc.
. http://www.epa.gov/aging/grants/winners/archs.htm
EPA Grant:
Safe Medicine Disposal for ME
. Mail-back program
- Univ. of ME, ME DEA, US Postal Service, other partners
- Collected 2,373 lbs of drugs during the grant period
. 2,123 lbs - non-controlled substances
. 250 lbs - controlled substances
- Take-back program still in operation post-EPA grant
. 20,000 mailers available at approx. 150 sites
. Collecting over 100 lb a week
. Funding in place through 2011
- No instances of diversion, theft, etc
- Secure delivery to Maine Drug Enforcement Agency for data
collection & destruction
. All non-controlled drugs are incinerated as HWs
. Controlled drugs are witness-incinerated as municipal solid waste at a
waste-to-energy facility
- Final report issued in April 2010: www.safemeddisposal.com
7
Environmental Regulations
. Once collected, unwanted controlled substances and other
unwanted pharmaceuticals must be managed in
accordance with all applicable federal, state, and local
environmental regulations
. Federal environmental regulations lay out the baseline
standards
- States may have more stringent or broader regulations than
federal EPA
. EPA comments focus upon the federal regulations as they
apply to disposal of household (ultimate user)
pharmaceutical waste
- Resource Conservation and Recovery Act (RCRA)
- Clean Air Act (CAA)
8
RCRA
. Non-hazardous wastes, such as municipal
solid waste, are regulated under Subtitle D of
RCRA (local and state level)
. Hazardous wastes are regulated under Subtitle
C of RCRA
9
Are Pharmaceuticals HW Under RCRA?
. A waste is hazardous if:
- It is specifically listed by EPA; or
- It exhibits a characteristic of HW
. Only a very small percentage of pharmaceuticals are
regulated HW
- 3 listed hazardous wastes are also DEA controlled
substances
. The regulations applicable to HW pharmaceuticals
depends on the type of generator
- Household, conditionally-exempt small quantity generator,
small quantity generator or large quantity generator
10
Applying RCRA to Households
. Household hazardous wastes (HHWs) are
exempt from federal Subtitle C regulations (40
CFR 261.4(b)(1))
- When Congress enacted RCRA, it indicated that
HW regulations should NOT apply to households
- Exemption applies even when HHWs are collected
- Some states do have more stringent requirements
and regulate HHW once collected and
consolidated (e.g., PA)
- EPA recommends that collected pharmaceutical
HHWs be managed and disposed of as HW
11
CAA
. No air standards apply directly to the ultimate user
(i.e., household) who disposes controlled substances
. Certain CAA regulations may apply if the controlled
substances are disposed of in landfills or incinerated
- EPA has issued emission standards for:
. Hazardous waste incinerators (under section 112(d) of the CAA)
. Solid waste incinerators (under section 129 of the CAA)
- Hospital, medical and infectious waste incinerators
- Municipal Waste Combustors (large and small)
- Other solid waste incinerators
. Municipal solid waste landfills (under sections 111 and 112 of the
CAA)
12
Additional Destruction and
Disposal Methods
. EPA suggests DEA:
- Discourage the sewering of household controlled
substances except
in the few instances where FDA
recommends flushing
. FDA recommends sewering for a short list of drugs that are
extremely dangerous to those for whom the drug has not been
prescribed (e.g., children and pets)
- Define what constitutes destruction and identify DEA-
approved methods
. Destruction methods must also be in accordance with all federal,
state and local environmental regulations
13
Expand Disposal Options for
Non-DEA Registrants
. It is EPA's understanding that long-term care facilities
(LTCFs) often dispose of unwanted controlled
substances by sewering
- LTCFs employees are typically not DEA-registrants, and as a
result they cannot:
. Return controlled substances to the LTCF pharmacy;
. Transfer controlled substances to a reverse distributor; or
. Transfer to a DEA-registrant for disposal
. EPA recommends that DEA allow LTCFs to become
DEA-registrants or authorize them to return/transfer
controlled substances in order to expand their
disposal options
14
Recordkeeping Requirements
. EPA recommends that DEA
- Streamline or modify the recordkeeping requirements for
take-back programs
. Current recordkeeping requirements could present
obstacles to take-back organizers because inventory
and recordkeeping requirements for controlled
substances are applied in various ways
- Pill-by-pill identification
- Separation and tracking prior to disposal
15
Summary
. In development of regulations, EPA recommends
that DEA:
- Develop a set of flexible options for pharmaceutical
take-back programs
- Ensure destruction/disposal of pharmaceuticals is in
accordance with all federal, state, and local
environmental regulations
- Define allowed additional destruction methods and
disposal options
- Streamline recordkeeping requirements for take-back
programs
16
Conclusion
. Thank you for inviting us to comment
. We look forward to working together on this issue
. For more information, please contact Lisa Lauer at
703-308-7418
17
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