FDA Foregoes Animal Welfare in Gene-Altering Guidance

AWI recently submitted comments urging greater consideration of animal welfare in guidance documents issued by the Food and Drug Administration to developers of animals with intentional genomic alterations (IGAs). IGAs are changes made to the genome by molecular technologies, including gene editing (deleting or altering a specific gene), and inserting genes from one species into the genome of a different species. 

The animal agriculture industry is very interested in IGAs, primarily because of their potential to increase farmed animal productivity and disease resistance. In some cases, IGAs may improve animal welfare. For example, most dairy cattle undergo a painful procedure to remove their horns or prevent horn growth, and IGAs can produce hornless cattle. However, many IGAs have the potential to negatively impact animal welfare. 

In 2021, AWI learned of a proposal to transfer regulatory oversight of animal IGAs from the FDA to the US Department of Agriculture. We expressed opposition to this change, as USDA oversight would likely be far less stringent. In the end, the FDA retained oversight of animals with IGAs; however, new guidance documents make clear that, even under the FDA, the IGA-approval process lacks robust assessment of animal welfare impacts and fails to consider sociopolitical implications (e.g., impact on small, independent farmers). In our comments, AWI encouraged substantive changes to address these shortfalls.

Program Terms: Farmed Animals

AWI Quarterly Terms: Government/Legal