Performance Improvement 2006. FDA’s Evaluation of the Seafood HACCP Program for Fiscal Years 2002/2003


On December 18, 1997, the Food and Drug Administration (FDA) adopted the Seafood Hazard Analysis Critical Control Point (HACCP) Regulation 21 CFR Part 123 final rule to ensure the safe and sanitary processing of fish and fishery products including imported seafood. The regulation mandates the application of HACCP principles to the processing of seafood. HACCP is a preventive system of hazard control that can be used by processors to ensure the safety of their products to consumers. The Office of Seafood developed an electronic form (FDA form 3501) to collect data from the field. Data is collected during regulatory inspections for each product inspected by FDA. The data included in the tables in this report are based on the number of inspections actually completed and not the total number of firms in the FDA inventory. Not all firms are inspected annually; decisions on which firms to inspect are based on level of risk and compliance history. Currently, all high-risk firms are inspected; there were 3,226 high- risk firms in the 2004 inventory. Domestically, this evaluation covers implementation of the program by U.S. fish and fishery products processors, as observed during regulatory inspections by FDA and some states operating under contract or partnership agreements with FDA. This report also includes information about HACCP implementation by domestic processors of raw molluscan shellfish, as observed during audits by FDA of inspections performed by state regulatory authorities under the National Shellfish Sanitation Program. Internationally, this report reviews the status of HACCP implementation by 176 processors in 20 countries that were visited by FDA inspectors during 2002 and 2003. It also covers progress by U.S. importers of foreign fish and fishery products in ensuring that their foreign suppliers are complying with U.S. HACCP requirements. As in previous evaluations, the tables show the most  significant elements of the program and provide the percentage of processors in each program year that succeeded in accomplishing each of these elements. The accompanying narrative addresses specific aspects of the data in the tables, including noteworthy trends and issues that are emerging, continuing, or reversing since the previous evaluation. The report makes five recommendations: (1) Continue to categorize processors of scombroid species and cooked ready-to-eat products as high risk manufacturers and inspect all annually; (2) Increase inspections of aquaculture firms and importers; (3) Work with the Seafood HACCP Alliance and NFI to develop and present HACCP training for seafood importers and aquaculture firms. We have completed one series of importer trainings in the large import districts with NFI at their regional meetings; (4) Issue the Fish & Fisheries Products Hazards and Control Guidance: Fourth Edition; (5) Continue follow-up on firms that need a plan but do not have one.

PIC ID: 8243; Agency Sponsor: FDA-CFSAN, Center for Food Safety and Applied Nutrition; Federal Contact: Creeden, John, 301-436-1419; Performer: FDA, Center for Food Safety and Applied Nutrition, Washington, DC

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