Modernizing the Approach to EPA and FDA Oversight of Animal Products Regulated as Pesticides or New Animal Drugs
EPA and the U.S. Food and Drug Administration (FDA) jointly released a whitepaper on the best approaches for updating the agencies’ oversight of various products regulated as either pesticides or new animal drugs. A modernized approach ensures that the oversight of various products regulated as either pesticides by EPA; or new animal drugs by FDA; 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. The agencies held a public webinar on March 22, 2023, to obtain feedback from stakeholders on the whitepaper and ideas for modernizing EPA and FDA’s approach to product oversight.
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) are generally regulated by EPA if they remain on the skin to control only external parasites (e.g., collars or sprays to control fleas, ticks) and by FDA if they are ingested and 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 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 that 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 (PDF), 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.
Therefore, in February 2023, the agencies announced the availability of the whitepaper that describes the current challenges and highlights the potential benefits of a modernized approach for oversight of these products.
To receive feedback on the whitepaper, EPA and FDA opened a 60-day public comment period starting February 23, 2023. The agencies received over 18,000 comments from environmental organizations, veterinarians, industry, pet and livestock owners, and other members of the public. In addition to comments submitted to the docket, the agencies also collected stakeholder feedback during a public meeting on March 22, 2023. All comments received during the comment period and the public meeting, are posted in docket EPA-HQ-OPP-2023-0103.
In reviewing the comments, EPA and FDA identified some common questions from stakeholders, such as:
- How do EPA and FDA currently regulate products and review animal safety and incident data?
- How could EPA and FDA coordinate more closely on animal health, environmental, and efficacy considerations for these products?
- If products transferred to FDA, how would products —particularly those used to protect livestock and honeybees—move from EPA to FDA? What would it cost for product manufacturers, how could it impact consumer access to products, and what would the FDA approval process look like?
EPA and FDA also identified some general comments and concerns from stakeholders, including:
- Support for an approach that would enhance animal safety for products used on pets, such as flea and tick products applied to cats and dogs.
- Recognition that FDA has a more robust regulatory infrastructure for regulating products used on or in animals.
- Support for a modernized approach to regulate genetically engineered pest animals used for population
- Desire for continued agency transparency and outreach as the modern approach is developed and possibly implemented.
The Agencies appreciate those stakeholders that took the time to submit comments and will continue engaging on this topic. As an initial step, the agencies have published answers to frequently asked questions to address some of the public's comments. See the Q&A.
At this time, the agencies do not have a timeline for potentially formalizing any of the approaches discussed in the whitepaper and anticipate that if the agencies implement any such changes, it could take several years to come to fruition. EPA and FDA appreciate the stakeholder engagement received to date and look forward to continuing the conversation.