EPA Announces Both EPA And FDA To Conduct Virtual Public Meeting And Request Comments On Modernizing Their Approach To Oversight Of Certain Products

Published date22 March 2023
Subject MatterEnvironment, Food, Drugs, Healthcare, Life Sciences, Environmental Law, Food and Drugs Law
Law FirmBergeson & Campbell
AuthorLisa R. Burchi and Barbara A. Christianson

On February 22, 2023, the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration's (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, 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. According to EPA, the purpose of the comment period and virtual public meeting is to obtain feedback from stakeholders on ideas for modernizing EPA's and FDA's approach to product oversight.

EPA also has opened a docket for the agencies to receive comments 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. EPA posted to the docket, and is requesting comments on, a document entitled, "WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight," (Whitepaper) which describes the current challenges and highlights the potential benefits of a modernized approach to oversight of these products. The Whitepaper is available at EPA-HQ-OPP-2023-0103, and comments on the Whitepaper are due on or before April 24, 2023.

In the Whitepaper, EPA focuses on two particular product types:

  • Products administered topically to animals (e.g., flea and tick collars): EPA states that the "agencies have historically determined oversight for products topically administered to animals to treat fleas and ticks based on whether the chemical is systemically absorbed into the bloodstream (FDA oversight) or remains on the skin (EPA oversight)." Based on new understandings that many of these topically administered products regulated by EPA are systemically absorbed into the bloodstream as well as agreement by the agencies that FDA is better equipped to evaluate and monitor products topically administered to animals, the agencies are considering the transfer of approximately 600 topically administered products for external parasites on animals currently regulated by EPA to FDA.
  • Genetically engineered pest animals (e.g., mosquitoes genetically engineered to control the mosquito population in the environment): EPA states a new approach can...

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