Overview
The EPA recently finalized its rule on “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.” The new regulations will require retailers, heath care facilities, pharmacies, and reverse distributors to examine – and likely restructure – their hazardous waste management practices. In addition, under this final rule, FDA-approved, over-the-counter nicotine replacement therapies are no longer considered hazardous waste when discarded, but e-cigarettes are still considered an acute hazardous waste and subject to the new requirements. The rule triggers new, stringent standards for these products and entities, and restricts the movement of product once it is considered waste. Speakers will address the new standards, compliance strategies and challenges, implications for pharmaceutical and nicotine manufacturers, and potential enforcement pitfalls.
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Speakers
Kristin Fitzgerald, Environmental Protection Specialist, Office of Resource Conservation and Recovery, EPA
Brian Knieser, Physical Scientist, U.S. EPA Office of Resource Conservation and Recovery
Elise Paeffgen, Senior Associate, Alston & Bird LLP
Laura Stanley, Economist, U.S. EPA Office of Resource Conservation and Recovery
Moderated by Caitlin F. McCarthy, Director, Associates Program, Environmental Law Institute
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ELISE PAEFFGEN is a Senior Associate at Alston & Bird LLP where she focuses her practice on compliance counseling and enforcement defense. Elise works with manufacturers, importers, and forward and reverse distributors to effectively navigate EPA, FDA, and DEA regulations and minimize enforcement risks. She provides counsel to FDA-regulated clients, such as pharmaceutical, medical device, cosmetic, and food manufacturers, on issues ranging from current good manufacturing practices (CGMP) to the management of hazardous waste pharmaceuticals. Elise has spent months inside pharmaceutical manufacturing and reverse distribution facilities in the U.S. and Europe managing EPA and FDA inspections and enforcement matters and implementing significant remedial action.
CAITLIN F. McCARTHY is the Director of the Associates Program at the Environmental Law Institute. In this role, Caitlin researches, facilitates, and leads programming for both ELI members and the broader public interested in environmental policy and law. Overseeing membership and educational programs, Caitlin engages law firms, corporations, and NGOs. With a dual focus on membership recruitment and public outreach, Caitlin oversees the Associates Department as well as 100+ programs per year. Her constant goal is to advance the environmental profession by designing and leading programs on cutting-edge issues in environmental law and policy.









































































































