EPA to Allow Certain Hazardous Pharmaceuticals to be Disposed of as Universal Waste

Late November, the United States Environmental Protection Agency ("EPA") announced plans to regulate certain spent hazardous pharmaceuticals and their containers as "universal wastes" under the agency's Resource Conservation and Recovery Act ("RCRA") Universal Waste Rule, 40 C.F.R. Part 273. The proposal, expected to be published in the Federal Register imminently and effective by 2010, will allow hazardous pharmaceuticals and containers to be disposed of in accordance with standards less stringent than those applicable to hazardous waste.

The proposal currently under consideration at EPA would apply to over 600,000 facilities that generate pharmaceutical waste. Such facilities would include hospitals, pharmacies, physicians' offices, dentists' offices, outpatient care centers, ambulatory health care services, residential care facilities, veterinary clinics, and other medical care facilities. The pharmaceuticals to be regulated are limited to those currently required to be disposed of as "hazardous waste" under federal law. These pharmaceuticals currently include those containing at least one of 31 chemical products presently listed as "hazardous" in the RCRA regulations, as well as other pharmaceuticals exhibiting one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. Examples of such pharmaceuticals include certain chemotherapy drugs, drugs containing a high level of alcohol (ignitable), strong solvents (corrosive), or certain chemicals such as arsenic, barium, cadmium, chloroform, chromium, lindane, m-cresol, mercury, selenium, or silver (toxicity).

This proposal is intended to ease the burden on healthcare facilities and help discourage the illegal disposal of pharmaceutical chemical ingredients into sewers and wastewater treatment plants, as these chemicals can pass through processing and enter surface and ground waters, according to EPA. Regulation under the federal Universal Waste Rule, as adopted by individual states, would subject hazardous pharmaceutical products to similar disposal practices currently required for batteries, pesticides, mercury-containing equipment, and lamps. Regulation under the Universal Waste Rule is intended to "streamline" the collection and handling requirements for widely-dispersed hazardous wastes, including requirements for storage, labeling, off-site shipment, employee training, responses to releases, and notification. EPA notes that the proposed rule will not have any significant economic impacts on the regulated community or adversely affect small businesses.

While this proposed rule is intended to ease burdens on health care facilities, this regulatory action is also part of EPA's increasing efforts to better understand the impact that disposal of all pharmaceuticals have on waste treatment facilities - including wastewater treatment plants that currently do not filter or otherwise exclude pharmaceuticals from water as part of treatment.

Upon publication of the proposed rule in the Federal Register, the public will have 60 days to submit comments to EPA. Please contact the professionals listed below, or your regular Crowell & Moring contact, for more information on the proposal or if you have interest in submitting comments to EPA.