Comments on the Proposed Management Standards for Hazardous Waste Pharmaceuticals

The Compliance Monitoring and Enforcement Task Force within the Hazardous Waste Subcommittee of the Association of State and Territorial Solid Waste Management Officials (ASTSWMO) appreciates the opportunity to provide comments on the proposed rule, Management Standards for Hazardous Waste Pharmaceuticals, published in the Federal Register on September 25, 2015 (80 FR 58013). These comments have not been reviewed or adopted by the ASTSWMO Board of Directors. In addition, individual State or Territorial hazardous waste programs may also provide comments based on their own State perspectives and experiences.

ASTSWMO Position Paper: A New Regulatory Approach to Pharmaceutical Waste Management

Many studies have demonstrated that pharmaceutical compounds are making their way into the environment. Although little can be done to prevent some pharmaceuticals from reaching environmental receptors, the destiny of waste pharmaceuticals can be controlled. The Association of State and Territorial Solid Waste Management Officials (ASTSWMO) understands that the U.S. Environmental Protection Agency (EPA) Office of Resource Conservation and Recovery is developing new regulations for management of pharmaceutical wastes to replace the December 2008 proposal that would have allowed those pharmaceutical wastes already regulated as hazardous waste under Subtitle C of the Resource Conservation and Recovery Act (RCRA) to be managed as universal wastes. ASTSWMO also understands that while EPA’s forthcoming proposal will be designed to offer flexibility to health care facilities that manage pharmaceutical wastes; it too will only apply to those pharmaceuticals currently regulated as a hazardous waste under RCRA. This Position Paper outlines a more holistic management approach that could apply to all post-manufacturing pharmaceutical wastes, not only those regulated as a hazardous waste. In developing this Paper, several articles and publications were reviewed. A complete bibliography of those reviewed is included.