Minor Improvements to a Misdirected Approach to Livestock Biotech

This May, the Food and Drug Administration (FDA) posted updated guidance for developers applying for regulatory approval of intentional genomic alterations (IGAs) in animals. The first section, Guidance for Industry 187A, provided a framework for when FDA would exercise enforcement discretion on new animal IGAs. The Breakthrough Institute shared our thoughts here.

Draft guidance 187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process” details how developers of “Category 3” traits—novel traits in animals intended for food use that could not be achieved through conventional breeding—should navigate the New Animal Drug Approval process. The Breakthrough Institute has submitted the attached comment to FDA’s Center for Veterinary Medicine.

New gene editing technologies can aid in the development and proliferation of livestock with traits that reduce the environmental impact of animal agriculture, bolster food supply resiliency, and improve animal health and welfare. Draft guidance 187B is an important step in creating a clear, consistent, and attainable path to regulatory approval for food animals with IGAs. We commend the FDA for clarifying many potential points of confusion and generally streamlining the approval process for developers of IGAs in animals. These changes reflect that the FDA is incorporating lessons on how best to regulate the products of a novel technology and is willing to be flexible.

Despite these improvements, the guidance would create an opaque and unpredictable application review process. This would discourage investment in IGAs that may have clear benefits, and may slow the approval process, especially if the number of applications increases.

Ultimately, the industry guidance illustrates the limitations of FDA’s general approach to regulating IGAs through the same process they use for new animal drugs. FDA is stretching a regulatory process to cover technology that it was not designed for. IGAs in animals intended for use as food should be considered separately from new animal drugs, with their own application process and regulatory structure based on the nature of the IGA and associated risks.