By Patrick D. Joyce, Jeryl L. Olson, and Craig B. Simonsen

shutterstock_178475264The 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. 80 Fed. Reg. 58014 (Sept. 25, 2015).

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:

NAICS Codes Description of NAICS Code
44611 Pharmacies
54194 Veterinary Clinics
6211 Physicians’ Offices
6212 Dentists’ Offices
6213 Other Health Practitioners (e.g., Chiropractors)
6214 Outpatient Care Centers
6219 Other Ambulatory Health Care Services
622 Hospitals
6231 Nursing Care Facilities (e.g., Assisted Living Facilities, Nursing Homes, U.S. Veterans Domiciliary Centers)
623311 Continuing Care Retirement Communities (e.g., Assisted Living Facilities with on-site nursing facilities)
Subset of 92219 Medical Examiners and Coroners’ Offices
Various NAICS Pharmaceutical Reverse Distributors

The Agency will accept public comments on the proposal, in Docket No. EPA-HQ-RCRA-2007-0932, until November 24, 2015.