Executive Summary
On January 17, 2025, the U.S. Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) announced that cat and dog food manufacturers whom the Food Safety Modernization Act Preventive Controls for Animal Food (PCAF) as codified in 21 C.F.R. part 507 require have a Food Safety Plan (FSP) and who use uncooked or unpasteurized materials derived from poultry or cattle must reanalyze their FSPs to include Highly Pathogenic Avian Influenza virus (specifically H5N1) as a known or reasonably foreseeable hazard.
Background
The regulations at 21 C.F.R. part 507 require that certain animal food facilities develop an FSP,[1] which must identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility, to determine whether there are hazards requiring a preventive control.[2] Those facilities must reanalyze their food safety plans at least once every three years[3] and whenever necessary to respond to new hazards and developments in scientific understanding.[4]
FDA Determines that Recent H5N1 Illnesses Necessitate Reanalysis of Food Safety Plans
On January 17, 2025, CVM determined that cat and dog food manufacturers who use uncooked or unpasteurized poultry or cattle derived materials in cat or dog food must reanalyze their food safety plans to include H5N1 as a new known or reasonably foreseeable hazard.CVM’s determination comes amidst a rise of H5N1 cases in domestic and wild cats in California, Colorado, Oregon, and Washington State associated with eating contaminated food products.H5N1 may be transmitted to cats and dogs that eat food products from infected poultry or cattle that do not undergo a processing step capable of inactivating the H5N1 virus—such as pasteurizing, cooking, or canning.Though H5N1 has not yet been detected in dogs, the U.S. Department of Agriculture (USDA) Animal and Plant Inspection Service (APHIS) has confirmed several cases of H5N1 in domestic cats.[5]
If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.
[1] See 21 C.F.R. Part 507, subparts A, C, D, E, and F. In general, the PCAF rule applies to facilities that are required to register with the FDA as an animal food facility under section 415 of the Federal Food, Drug, and Cosmetic Act because they manufacture, process, pack, or hold animal food for consumption in the United States.
[2] 21 C.F.R. § 507.33(a)(1).
Back
