February 15, 2023
Today, the Office of Chemical Safety and Pollution Prevention (OCSPP) at the U.S. Environmental Protection Agency (EPA) and the Center for Veterinary Medicine (CVM) at the U.S. Food and Drug Administration (FDA) are announcing plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products in an efficient and transparent manner and in alignment with each agency’s expertise, with the goal of improving protection of human, animal, and environmental health.
As part of this effort, 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 to the oversight of various products regulated as either pesticides or new animal drugs. Members of the public will have the opportunity to present their perspectives at the meeting, and a docket will be available for the submission of written comments.
Currently, EPA and FDA 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.
For example, parasite treatment products applied topically to animals generally 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 now understand that many of the topically administered products currently regulated by EPA do not remain on the skin and are actually absorbed into the bloodstream, highlighting challenges with the current approach and raising different safety concerns than originally anticipated.
Additionally, 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 September 12, 2022, has further directed the agencies to improve the clarity and efficiency of the regulatory process for biotechnology products, underscoring the need for continued coordination between the agencies on biotechnology.
The agencies’ current approach to determining whether EPA or FDA is the appropriate regulator of certain products does not effectively reflect or accommodate scientific advancement, and it has become clear in some cases that the current approach has resulted in misalignment between product characteristics and the agency better equipped to regulate the product. A modernized approach would ensure that the oversight of these products better aligns with each agency’s expertise, accounts for scientific advancement, avoids redundancy, better protects animal health and safety, and improves regulatory clarity for regulated entities, animal owners, veterinarians, and other stakeholders.
Additional information about the public meeting, including more detailed information describing challenges with the current approach, and how to submit public comments, will be posted on both FDA’s and EPA’s websites starting next week.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.