FDA Issues Final Guidance on Reconditioning of Fish and Fishery Products by Segregation
The U.S. Food and Drug Administration (FDA) recently published “Guidance for Industry: Reconditioning of Fish and Fishery Products by Segregation.” This final guidance clarifies steps that seafood industry representatives can take to segregate non-violative products from products that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). This includes decomposing products and products contaminated with pathogens, unlawful animal drugs, or histamine.
The guidance provides recommendations for reconditioning by segregation based on a production records, and segregation based on sampling and testing. The guidance also informs industry of what information is important to include in reconditioning by segregation proposals, and how FDA evaluates these proposals.