EPA and FDA Seek Public Input On Modernizing Regulatory Oversight Over Products Regulated as Pesticides or New Animal Drugs

On February 15, 2023, 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) announced plans to seek public input on the best approaches to update their respective oversight responsibilities for products regulated as pesticides or new animal drugs. The agencies envision that the update would modernize regulatory oversight to reflect recent scientific advancements, improve regulatory clarity and avoid redundancy, better protect animal health and safety, and assure that regulatory responsibilities better align with each agency’s expertise.

As part of these plans, EPA and FDA will hold a joint virtual public meeting on March 22, 2023. In a February 23, 2023 Federal Register Notice[1] EPA provided further information on the topics to be covered at this meeting. Finally, in conjunction with FDA, EPA published on February 22, 2023 a white paper outlining the challenges with the current regulatory approach and the agencies’ views regarding a modernized approach.

Currently, EPA and FDA generally determine whether a product is regulated as a pesticide or new animal drug based upon a rationale articulated in a Memorandum of Understanding (MOU), established in 1971 and subsequently updated in 1973. In particular, the MOU deems certain products to be both pesticides and animal drugs subject to simultaneous EPA and FDA jurisdiction, including products administered parenterally, absorbed through the skin surface, introduced into wound or body openings, and applied topically. The MOU generally assigns primary jurisdiction to EPA if such products are applied to the animal topically solely for control of external parasites, such as topical products that remain on the skin to control fleas and ticks, subject to limited exceptions for certain cattle products.[2] All other products intended for animals are subject to FDA oversight, including products that are administered parenterally to control internal parasites (e.g., intestinal worms). Accordingly, for parasite or insecticide treatments, the dividing line between EPA and FDA oversight often depends on whether or not the product is administered to the animal parentally or absorbed systemically into the bloodstream. The agencies have long maintained that topically-administered pesticides are not absorbed systemically and therefore are regulated by EPA.

In the announcement, however, the agencies state the view that “many topically administered products currently regulated by EPA … are actually absorbed into the bloodstream,” highlighting the agencies’ perception of a potential misalignment between the product’s characteristics and which agency primarily regulates it, as well as other challenges.

In the white paper, EPA and FDA make clear that they seek to transfer “oversight from EPA to FDA of topically administered products for external parasites of animals, which are currently regulated as pesticides,” but do not explain the details of how that might happen.

In addition, EPA and FDA note that genetically engineered (GE) pest animals are gaining interest as an innovative pest control tool, and regulatory oversight of such products is not addressed in the MOU, which was first established over 50 years ago. Notably, FDA has issued guidance in recent years to clarify its position with respect to the regulation of certain GE insects. Specifically, FDA clarified in Guidance for Industry #236 that products “intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development)” would be regulated by EPA as pesticides, whereas products “intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans” would be regulated by FDA.[3]

Recent initiatives by the federal government further underscore the need to update oversight responsibilities for biotechnology products. In the 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products, EPA, FDA, and the U.S. Department of Agriculture (USDA) agreed to clarify the government’s regulatory scheme for GE insects.[4] On September 12, 2022, President Biden issued Executive Order (E.O.) 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” with the goal of accelerating biotechnology innovation across multiple sectors, including health, agriculture, and energy.[5] Among other objectives, E.O. 14081 strives to support such innovation “by clarifying and streamlining regulations in service of a science- and risk-based, predictable, efficient, and transparent regulatory system to support the safe use of products of biotechnology.”[6] Pursuant to E.O. 14081, on December 20, 2022, the Office of Science and Technology Policy (OSTP) issued a notice of request for information on behalf of EPA, FDA, and USDA to engage external stakeholders to help clarify and streamline biotechnology regulations.

As part of their effort to update oversight responsibilities for pesticide and new animal drug products, 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 oversight approach. The agencies state that “[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.” However, the agencies have not explained the specifics of their vision for a “modernized approach,” and the purpose of seeking public comment is in part to determine whether and how any such modernization might in fact be beneficial. EPA and FDA are specifically seeking input on the following 7 questions:

1. What do you perceive as the strengths and weaknesses of each agency in regulating these types of products?
2. Are there additional or different challenges that EPA and FDA did not identify in the whitepaper?
3. How can EPA and FDA communicate with their stakeholders about the regulation of these products in a clearer and more transparent manner?
4. For regulated entities, how have you historically determined which agency to approach first to bring your product to market?
5. For consumers, do you know who is regulating the products you use on your animal(s)? If you have a concern or complaint about a specific product, do you know which agency to contact?
6. How should EPA and FDA modify product oversight to better align with each agency’s mission and expertise?
7. What difficulties would you envision if EPA and FDA were to modify product oversight to better align with each agency’s mission and expertise, and how could they be mitigated?

As noted, the agencies are suggesting shifting jurisdiction over topically-applied flea and tick or other external parasite products from EPA to FDA, but have not provided much detail. Likewise, the white paper appears to contemplate EPA exercising primary oversight over GE pest control animals, under an approach similar to that articulated in GFI #236.

The agencies will also be accepting written comments for a 60-day period beginning on February 23, 2023, through April 24, 2023.

Given the potential scope of these changes, interested parties should consider submitting written comments during the 60-day public comment window, which EPA indicates will close on April 24, 2023. In addition, the joint virtual public meeting hosted by EPA and FDA on March 22, 2023 provides another opportunity for interested parties to express their views.

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