EPA Seeks Comment on Proposal to Add Hazardous Pharmaceutical Waste to Universal Waste Rule

December 24, 2008 // Published as a news service by IHS

The proposed rule encourages generators to dispose of pharmaceutical waste that is classified as non-hazardous under the Resource Conservation and Recovery Act (RCRA) as universal waste. The proposal will also facilitate the collection of personal medications that are classified as household hazardous waste so they can be managed properly.

The proposed rule applies to pharmacies, hospitals, physicians’ offices, dentists’ offices, outpatient care centers, ambulatory health care services, residential care facilities and veterinary clinics, as well as other facilities that generate hazardous pharmaceutical waste. It does not apply to pharmaceutical manufacturing or production facilities.

Currently, the federal UWR includes batteries, pesticides, mercury-containing equipment and lamps. Universal wastes typically are generated in a variety of settings including industrial settings and households, by many sectors of society and may be present in non-hazardous waste management systems, said the EPA.

There are three categories of RCRA hazardous waste generators, according to the EPA. A facility's generator status depends on the total amount of hazardous waste generated at the entire site in a calendar month, which then determines the waste management requirements applicable to the facility under RCRA.

Facilities that generate 1,000 kilograms (kg) or more of hazardous waste per month or greater than 1 kg of acute hazardous waste per month are considered large quantity generators (LQGs).

Other facilities qualify as small quantity generators (SQGs) if they generate more than 100 kg per month, but less than 1,000 kg per month of hazardous waste. SQGs are subject to fewer requirements than LQGs.

For example, SQGs do not need to complete a biennial report and have fewer personnel training and contingency planning requirements than LQGs (see 40 CFR 262.34(d) (5)).

Additionally, facilities qualify as conditionally exempt small quantity generators (CESQGs) if they generate less than or equal to 100 kg of hazardous waste per month, or less than or equal to 1 kg of acutely hazardous waste per month.

CESQGs are not subject to the RCRA subtitle C hazardous waste regulations provided that they comply with the requirements set forth in 40 CFR 261.5(f)(3) and (g)(3), said the EPA.

Finally, under the household hazardous waste exclusion in 40 CFR 261.4(b) (1), hazardous wastes generated by households are not subject to the hazardous waste regulations.

Because RCRA generator status is determined on a monthly basis, it is possible that a generator's status can change from one month to the next depending on the amount of hazardous waste generated in a particular month, said the EPA.

This is commonly referred to as "episodic generation."' If a generator's status does change, the generator is required to comply with the respective regulatory requirements for that class of generators for any hazardous waste generated in that particular month.

The EPA requests comments on the proposed definition of "pharmaceutical." Specifically, the EPA seeks comment on whether the definition of "pharmaceutical" is clear and appropriate and whether it encompasses the full range of pharmaceuticals available.

In addition, the EPA seeks comment on whether this definition inadvertently includes items not intended to be incorporated into the universal waste system, such as dental or medical devices.

The EPA also requests comment on, in order to add hazardous pharmaceutical wastes to the UWR, whether additional elements not included in this proposal need to be added to this proposed definition.

Finally, the EPA requests comment on whether the proposed definition of "pharmaceutical universal waste" is clear and appropriate.

For more information, go to http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day-02/f28161.htm.

Source: U.S. Environmental Protection Agency (EPA).