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U.S. EPA To Issue Hazardous Waste Pharmaceuticals Rule

September 28, 2015

 

A new proposed rule entitled “Management Standards for Hazardous Waste Pharmaceuticals” (“Proposed Rule”) is expected to be published by the U.S. Environmental Protection Agency in the Federal Register within the coming weeks. The Proposed Rule is the culmination of 8 years of discussion and public comment on the best way to stem the release of an estimated 6,400 tons/year of pharmaceutical waste from human and animal healthcare facilities into waterways.

The Proposed Rule includes a sector-specific set of regulations for the management of hazardous waste generated by healthcare facilities (including pharmacies) and reverse distributors (entities that return unused pharmaceuticals to specialized brokers). The Proposed Rule does not apply to manufacturers.

In 2008, EPA proposed to add pharmaceuticals to the types of hazardous wastes that could be managed as Universal Wastes (73 FR 73520, December 2, 2008). Although there was support for the new regulations, there were numerous concerns over the lack of notification requirements for those facilities that generate, handle, or transport pharmaceutical “universal wastes,” as well as for the lack of tracking requirements for the shipment of these wastes. The EPA decided not to finalize the 2008 proposed rule, but rather developed a proposal for new standards for the management and disposal of pharmaceutical hazardous waste that is generated by healthcare-related facilities. This new proposed rule will only pertain to those pharmaceutical wastes that meet the current definition of a Resource Conservation and Recovery Act (“RCRA”) hazardous waste.

Generally, it is the responsibility of the generator of a solid waste to determine if a waste is hazardous. Certain pharmaceuticals currently on the market meet RCRA’s definition of hazardous waste when discarded, so the generator must manage the waste in accordance with all applicable federal, state, and/or local environmental regulations. A pharmaceutical is considered a hazardous waste under RCRA in one of two ways. First, a discarded pharmaceutical can be a listed hazardous waste if it is a commercial chemical product that is listed under RCRA’s P- or U-list, and the pharmaceutical has not been used for its intended purpose.

Second, if the discarded pharmaceutical is not on the P- or U- list, then the pharmaceutical may be a hazardous waste if it exhibits one or more of the hazardous waste characteristics. Under the federal requirements, waste is a characteristic hazardous waste if it is ignitable (D001), corrosive (D002), reactive (D003), or toxic (D004–D043). A number of pharmaceuticals are prepared in alcohol, which may cause the waste to be hazardous due to ignitability (D001), even if the active pharmaceutical ingredient itself is not considered hazardous waste. The Regulatory Impact Analysis for the proposed rule includes a list of pharmaceuticals that EPA believes to be hazardous waste when disposed, although this list should not be considered exhaustive.

Several of the proposed provisions are also responsive to the Notice of Data Availability (79 FR 8926, February 14, 2014) that EPA issued on the retail sector, asking for comment on hazardous waste management practices in that sector and on challenges they face in complying with the RCRA.

EPA has provided a pre-publication version of the proposed rule for review. Note that this is not the official version of the rule that will be published in the Federal Register. Comments on this proposal will be accepted for 60 days following Federal Register publication. To submit comments, go to Regulations.gov, search for Docket No. EPA-HQ-RCRA-2007-0932, and follow the online instructions.


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