The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is co-hosting a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. Additionally, EPA is opening a docket for the agencies to receive public comment on their current approach to the oversight of various products regulated as either pesticides by EPA or new animal drugs by FDA, with a focus on parasite treatment products applied topically to animals and in genetically engineered pest animals for use as pest control tools. The agencies are also announcing the availability of, and soliciting comment on, a document entitled, “WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight,” which describes the current challenges and highlights the potential benefits of a modernized approach to oversight of these products.
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 (including pets) generally are regulated by EPA if they remain on the skin to control only external parasites (e.g., collars or spot-ons to control fleas and ticks) and by FDA if they are absorbed systemically into the bloodstream. 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 and which can reduce the need for conventional pesticides, 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. Recently, Executive Order 14081 (PDF), 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 whitepaper and public meeting only address EPA and FDA oversight.
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.
EPA and FDA are considering how best to update 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. The purpose of the public comment period and virtual public meeting is to obtain feedback from stakeholders on the whitepaper and ideas for modernizing EPA’s and FDA’s approach to product oversight.
Upon publication of the Federal Register notice announcing the upcoming virtual public meeting, the whitepaper will be available for public comment for 60 days in docket EPA-HQ-OPP-2023-0103 at www.regulations.gov. Comments submitted to the docket and/or presented at the public meeting should be limited to the questions/topics posed in the Federal Register Notice only.
Registration for the virtual public meeting closes at 11:59 p.m. Eastern Time on March 15, 2023. Requests for oral presentations must be made by March 15, 2023. Public comments can be submitted electronically via the Federal eRulemaking Portal starting February 23, 2023, until April 24, 2023. All comment submissions received must reference Docket No. EPA-HQ-OPP-2023-0103. To register to attend the public meeting, visit https://www.eventbrite.com/e/547810324427. To request to make an oral presentation or for detailed instructions for submitting electronic comments, visit EPA’s public meeting webpage for more information.
For more information:
- Virtual Public Meeting: FDA and EPA Product Oversight
- Federal Register Notice
- Docket: EPA-HQ-OPP-2023-0103
