Draft Guidance for Industry on Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products." This draft guidance sets forth the agency's interpretation of its Hazard Analysis Critical Control Point (HACCP) regulations for fish and fishery products as they pertain to the inspection of facilities and records. The agency is clarifying that a processor's refusal to allow FDA to inspect its processing facilities, or to provide HACCP records or plans to an inspector during an inspection, violates the regulations and thus may trigger a regulatory response by the agency. FDA is issuing this clarification because some domestic firms have questioned whether records can be made available after an inspection (rather than during) and some foreign firms have canceled scheduled inspections by FDA, but offered to make records available for review. This guidance applies to foreign processors that export fish and fishery products to the United States as well as to domestic processors.