The U.S. Environmental Protection Agency this week released a pre-publication copy of a proposed rule on pharmaceutical hazardous wastes in healthcare and related industries that will significantly affect our healthcare clients.

Under the proposed rule, aimed at hospitals, clinics, nursing and assisted care facilities, retail stores with pharmacies, and reverse distributors that generate pharmaceutical waste, the Agency expects to “reduce the burden on healthcare workers and pharmacists” by creating specific regulations addressing “wastes” at these facilities. EPA’s proposed generator rule will regulate the labeling, managing and disposal of pharmaceutical waste, including over-the-counter medications, as well as, facilities’ emergency planning and preparedness, an area that is at best murky under current regulations.

In EPA Assistant Administrator Mathy Stanislaus’ blog about the proposal, “Making Hazardous Waste Regulations Work for Today’s Marketplace,” he explained that “we’re proposing to remove the traditional manufacturing-based hazardous waste generator requirements and instead provide a new set of regulations designed to be workable in a healthcare setting while ensuring safe management and disposal of hazardous waste pharmaceuticals.” (Emphasis added). Stanislaus says the proposal will ban the sewering, or flushing down the toilet or sink, of hazardous waste pharmaceuticals from healthcare facilities. The Agency expects the rule to prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually.

The rule will define what are and are not “hazardous waste” pharmaceuticals, and will eliminate the concepts of small quantity generators (SQGs) or large quantity generators (LQGs), so that all generators and pharmaceutical reverse distributors, regardless of the volume of waste, “will be required to manage their hazardous waste pharmaceuticals under subpart P of 40 CFR part 266, instead of 40 CFR part 262.” This means the proposed standards will not be an optional alternative to managing hazardous waste pharmaceuticals under 40 CFR part 262 — they will be mandatory standards — and they may not provide the flexibility EPA desires.

The following facilities will potentially be regulated under the proposed rule:

Click here to view table.

The Agency will accept public comments on the proposal, in Docket No. EPA-HQ-RCRA-2007-0932, for sixty days following the official publication in the Federal Register.