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.
The guidance does not have the effect of law and does not supersede Compliance Policy Guide Sec. 160.700, “Reconditioning of Foods Adulterated Under 402(a)(4)”; the document is intended only to provide clarity on existing legal requirements. It also does not apply in situations where reconditioning is proposed by means other than segregation, such as by cooking or conversion to animal feed. FDA cautions that segregation alone may not be sufficient means of reconditioning adulterated products under section 402(a)(4) of the FD&C Act.