EPA Announces Both EPA And FDA Seek Public Input On Modernizing Their Approach To Oversight Of Certain Products

• Jurisdiction: United States,Federal
• Law Firm: Bergeson & Campbell
• Subject Matter: Environment, Food, Drugs, Healthcare, Life Sciences, Environmental Law, Food and Drugs Law, Biotechnology & Nanotechnology
• Author: Lisa R. Burchi and Barbara A. Christianson
• Published date: 22 March 2023

On February 15, 2023, the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency's expertise, thereby improving protection of human, animal, and environmental health.

EPA and FDA will hold a joint virtual public meeting on March 22, 2023, to provide information and receive public comment on the agencies' current approaches for the oversight of various products regulated as either pesticides or new animal drugs. EPA and FDA state that members of the public will have the opportunity to comment during the meeting, and a docket will be available for the submission of written comments.

As background, EPA and FDA currently determine regulatory oversight of pesticides and new animal drugs based on the rationale described in a Memorandum of Understanding (MOU) between the agencies signed in 1971 and revised in 1973. Since that time, pesticide and animal drug technologies, and both agencies' understanding of these technologies, have evolved. Examples provided include the following:

• Parasite treatment products applied topically to animals are regulated by EPA if they remain on the skin to control only external parasites (e.g., fleas, ticks) and by FDA if they are absorbed systemically into the bloodstream to control internal parasites (e.g., intestinal worms). The agencies state they now understand that many of the topically administered products currently regulated by EPA may not remain on the skin and are instead absorbed into the bloodstream. EPA and FDA are thus questioning the current approach and potentially different safety concerns.
• Genetically engineered (GE) pest animals, which are gaining interest as a pest control tool, were not envisioned 50 years ago when the original regulatory approach was developed. As agreed in the 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products, EPA and FDA have considered how to update their respective responsibilities with the goal of developing an efficient, transparent, and predictable approach for overseeing GE insects and other pest animals Recently, Executive Order 14081, issued...