November 11, 2015
Waste Pharmaceuticals from Homes Still Excluded from RCRA
Per §261.4(b)(1), household hazardous waste (HHW) is excluded from hazardous waste regulation if it meets two criteria: 1) the waste is generated by individuals on the premises of a temporary or permanent residence, and 2) the waste is composed primarily of materials found in the waste generated by consumers in their homes. Amidst the recent regulatory actions by EPA and the Drug Enforcement Administration (DEA) to require appropriate management of waste pharmaceuticals, EPA has recently released guidance clarifying the status of expired or unwanted pharmaceuticals generated in homes. [RO 14853]
The new guidance reiterates that pharmaceuticals from a home, to the extent they would otherwise be hazardous waste, are excluded from RCRA hazardous waste regulation as HHW. This exclusion applies even when the HHW is a hazardous controlled substance that is collected at DEA-authorized collection locations. Non-household pharmaceutical hazardous waste continues to be regulated under RCRA, but EPA has recently proposed management standards specific to hazardous waste pharmaceuticals. [September 25, 2015; 80 FR 58014]
In previous guidance, EPA recommends the incineration of pharmaceuticals collected from households during take-back events, mail-back events, or other collection programs. [RO 14833] The agency recommends that these household pharmaceuticals be combusted in a RCRA-permitted incinerator or cement kiln, or at the very least, in a unit that meets EPA’s large or small municipal waste combustor standards. Combustion of household pharmaceuticals in such units would be protective of the environment and could also meet DEA’s goal of preventing diversion of controlled substances.
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This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.