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EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their unused pharmaceuticals that meet hazardous waste criteria, and would offer flexibility for occasional and small quantity hazardous waste generators in managing their waste.

The first proposed rule would establish new management standards for hazardous waste pharmaceuticals for health care facilities, which would include hospitals, health clinics, other medical facilities, pharmacies, and retailers that sell over-the-counter medications. The rule would also apply to pharmaceutical reverse distributors, which often help health care facilities manage their unused or expired waste pharmaceuticals.

The second proposed rule would revise EPA’s hazardous waste generator regulations in ways intended to update the generally applicable hazardous waste regulatory program, including to ease requirements for entities that typically generate small amounts of hazardous waste but occasionally generate larger quantities from non-routine events.

Interested parties will have 60 days to provide comment to EPA once the proposed rules are published in the Federal Register. Retail pharmacy operators, health care facilities, and reverse distributors should consider commenting. For the second proposed rule, practically all industrial facilities, including manufacturers, may wish to review the proposal and provide comment.

The proposed rules arise in part to address hazardous waste compliance challenges that have emerged in the health care and retail sectors. EPA’s hazardous waste generator regulations were designed for manufacturing and establish different requirements based on amounts of hazardous wastes generated in a month, distinguishing between large quantity generators, small quantity generators, and conditionally exempt small quantity generators. EPA’s proposed pharmaceutical hazardous waste rule seeks to address challenges arising from the often inconsistent quantities and numerous types of pharmaceutical waste generated at health care facilities. EPA acknowledges that these facilities may stock thousands of pharmaceutical products to address patient needs and may generate small amounts of waste at multiple locations within a facility where many workers may lack the expertise to make hazardous waste determinations. As a result, health care facilities may struggle to comply with existing hazardous waste regulations that were designed for manufacturing facilities that often generate larger, more predictable amounts of hazardous waste from fewer streams and locations.

The proposed rule is thus designed to simplify waste management practices by establishing new requirements for health care facilities that are generators of hazardous pharmaceutical waste, and for all reverse distributors regardless of their hazardous waste generator status. Under the proposal, health care facilities that qualify as conditionally exempt small quantity generators still would be subject to most existing rules for that category. However, EPA’s proposal would bar health care facilities and reverse distributors from disposing of hazardous waste pharmaceuticals in sinks or toilets. EPA claims that, if adopted, the regulations would prevent more than 6,400 tons of hazardous waste pharmaceuticals annually from entering the nation’s drinking supply.

In the second measure, EPA proposes various revisions to regulations governing hazardous waste generation for most industries. These include revisions designed to allow smaller volume generators of hazardous waste to retain their status under certain conditions when their monthly hazardous waste generation would otherwise exceed applicable limits because of non-routine events, such as cleanup from a spill. Further, the proposed rule would allow conditionally exempt generators to ship their hazardous waste to a large quantity generator, allowing companies with multiple facilities or satellite locations to consolidate hazardous waste for management in one location.

Additionally, EPA is proposing other revisions that would affect many generators of hazardous waste. One would require small and large generators to re-notify EPA on a periodic basis after obtaining a hazardous waste identification number. EPA also proposes revisions to the labeling requirements, emergency response provisions, and other aspects of its hazardous waste regulations.

Ballard Spahr’s Environment and Natural Resources Group has extensive experience preparing public comments on national rulemakings. The Group also advises on national and regional compliance, permitting, development, business planning, and contamination matters arising in connection with environmental and natural resources laws and claims, including a particular focus on climate change and sustainability. For more information, please contact Robert B. McKinstry, Jr. at, Ronald M. Varnum at, or Julia Johnson at

Copyright © 2015 by Ballard Spahr LLP.
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