united states coast guard

ALCOAST COMMANDANT NOTICE                                CANCEL DATE  06 JAN 2021

R 071053 JAN 20
UNCLAS //N16478//
ACN 002/20
A. Hazardous Waste Management Manual, COMDTINST M16478.1 (series)
B. Coast Guard Medical Manual, COMDTINST M6000.1 (series)
C. Environmental Protection Agency (EPA) Final Rule, Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, Title 40 of the Code of Federal Regulations (CFR) Part 266 Subpart P., Volume 84 Federal Register 5816, February 22, 2019
D. Drug Enforcement Agency (DEA) Final Rule, Disposal of Controlled Substances by Registrants, Title 21 CFR Part 1317 Subparts A&C
E. Pharmaceutical Waste Management Process Guide
1. In accordance with REF (A), unit commanders, commanding officers and officers-in-charge are responsible for ensuring the proper storage and handling of hazardous waste, ensure the proper shipment for off-site disposal, and provide initial and annual training on local, state and
federal regulations.
2. In accordance with REF (B), pharmaceutical hazardous waste (PHW) generators are considered stand-alone programs that produce small amounts of PHW. As a subset of hazardous waste, all units generating PHW, must comply with all applicable state and federal regulations pertaining to the accumulation, off-site shipment, and disposal of PHW.
3. Updated PHW regulations were published by the EPA in REF (C). This rule is designed to
improve regulatory clarity while decreasing the complexity of compliance.
4. Aligned with EPA’s approach of minimizing complexity and conservative waste management,
the Coast Guard policy is to consolidate non-hazardous and hazardous pharmaceutical waste, and manage it all according to the regulations in 40 CFR Part 266 Subpart P. 
5. Effective date. The PHW regulations became effective as follows:
   a. 40 CFR Part 266 Subpart P will be effective in unauthorized states and Territories
(other than Guam) on August 21, 2019 and must be adopted by all authorized states and U.S.
Territories in accordance with the below schedule:
      i. July 1, 2021 in states authorized to manage the HW program in lieu of the federal program.
      ii. July 1, 2022 in authorized states that require a statutory amendment to change regulations.
   b. The Nicotine Replacement Therapy rule is effective:
      i. August 21, 2019 for non-authorized states (Alaska, Iowa) and U.S. Territories (other than Guam).
      ii. Authorized states, the amendment to the nicotine listing is effective only after the state
adopts the amendment. Authorized states are not required to adopt this amendment, and there is no deadline for adoption of this provision. 
6. HSWL SC must designate a PHW coordinator at every PHW generating site. 
7. The PHW coordinator must ensure compliance with local, state and federal PHW regulations.
8. Refer to REF (E) for complete regulatory requirements, assignment of role and responsibilities, and further detailed guidance for PHW management and state-specific requirements.
9. REF (E) may be accessed on the COMDT (CG-47) Office of Environmental Management (OEM) Agency portal site at: or the COMDT (CG-47) OEM internet site at:
10. REFs (A) and (B) will be revised to implement these changes and they will be released within the next year.
11. POC for PHW management: COMDT (CG-1121): CAPT Paul T. Michaud, Pharmacy Force Manager, at (202) 475-5171 or or COMDT (CG-47): Jill Giggleman, Environmental Protection Specialist, at (202) 475-5692 or
12. Released by RDML Nathan A. Moore, Assistant Commandant for Engineering and Logistics, and RADM Dana L. Thomas, Director Health, Safety, and Work-Life.
13. Internet release is authorized.