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  1. Development & Approval Process

Modernizing FDA’s and EPA’s Approach to Oversight of Products for Animals Regulated as Pesticides or New Animal Drugs

In March 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention co-hosted a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM), and EPA opened a docket for the agencies to receive public comment on their current approach to the oversight of various products for animals regulated as either pesticides by EPA or new animal drugs by FDA. The agencies also announced the availability of a whitepaper 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 for oversight of these products. EPA and FDA are continuing to consider 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.

For more information, see the whitepaper, FDA’s CVM Update, and FDA’s public meeting webpage. 

Update on Public Meeting and Public Comment Period Response

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 control (such as genetically engineered mosquitoes).
  • Desire for continued agency transparency and outreach as the modern approach is developed and possibly implemented.

As an initial step, the agencies have published on FDA’s new webpage the answers to some of the public’s frequently asked questions. 

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.

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