U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
February 13, 2001

FDA’s Seafood HACCP Program:
Mid-Course Correction

Introduction: The General Accounting Office (GAO) has released a report evaluating FDA’s seafood HACCP program. GAO concludes that while FDA has made progress in ensuring the safety of seafood through HACCP, the program needs to be strengthened in order to reach its full objective. This report confirms the findings of a recent internal evaluation by FDA’s own Office of Seafood, released in December 2000. Accordingly, FDA is instituting a Mid-Course Correction to further strengthen its Seafood HACCP program.

What is HACCP? HACCP stands for Hazard Analysis Critical Control Points. The HACCP system focuses on identifying and preventing hazards that could cause foodborne illnesses rather than relying on spot-checks of manufacturing processes of finished seafood products to ensure safety. FDA’s 1997 science-based HACCP regulations initiated a landmark program designed to increase the margin of safety that U.S. consumers already enjoyed and to reduce seafood related illnesses to the lowest possible levels.

• Increased Inspection frequency: The Seafood HACCP program has dramatically increased the frequency of government inspections. Before the seafood HACCP program, FDA averaged seafood processor inspections only once every four years. After the implementation of the 1997 seafood HACCP program, the frequency of inspections increased to annual.

• Results show steady progress: FDA’s 1998-1999 HACCP Program evaluation documented that the HACCP program is being implemented by about 3600 U.S. seafood processors, most of which are small businesses, that collectively process over 350 species of fish. FDA’s evaluation reflected steady progress between 1998 and 1999 and showed that a significant majority of processors are doing well on most of the individual elements of the program. Over half have succeeded in all elements, a difficult standard to achieve.

• Progress confirmed by outside surveys : Two surveys of the seafood industry, one by the New York Sea Grant Extension Program and one by the Seafood HACCP Alliance, report that, as a result of FDA’s HACCP program, the seafood industry is acquiring a better understanding of food safety hazards and how to control them. As a result, the industry is engaging in significant upgrades in facilities, equipment, and daily plan operations to ensure safety. Implementation of these state-of-the-art preventive controls by the seafood processing industry contributes to a significant increase in the margin of safety for consumers of these products.

• FDA’s evaluations also showed that gaps exist and that certain segments of the seafood industry clearly lagged behind. Accordingly, more action is needed.

FDA is instituting a mid-course correction to its Seafood HACCP program to focus on those products that present the highest risk to consumers.

• Scope: FDA will intensify its focus on seafood processors whose products present the highest risk to consumers:
  1. those firms that need to control for pathogens;
  2. those firms that need to control for histamines (these can cause allergic reactions); and
  3. those firms that do not have HACCP plans.

• Actions: FDA believes that seafood processed by these three categories of firms present the highest risk to consumers, and so the Agency is redoubling its efforts toward these. This will mean more frequent inspections of noncompliant firms; more extensive laboratory testing for pathogens and histamines; and, ultimately, enforcement action where appropriate.

  In addition, the following actions have already been taken, or are in process, to strengthen the HACCP Program for seafood:

  • Improved guidance and training to the industry and regulators on control of pathogens and histamine;
  • Development of an inspector certification program that emphasized knowledge of controls for pathogens and histamine;
  • Development of guidance for fishing vessel operators to address proper handling of fish that can form histamine;
  • Development of guidance for aquaculture operators to prevent pathogen contamination of aquaculture sites;
  • Increased emphasis on compliance by foreign processors and increased surveillance of imports;
  • Creation of a National Seafood HACCP Inspection Database that collects information on the details of seafood processors’ preventive controls for safety.

• Additional steps: Because some of the actions described above were already phased in during calendar year 2000, FDA expects to see additional progress in ensuring the safety of seafood consumed by the public. FDA may also make future refinements once data from the inspections in 2000 are available.

February 13, 2001

Hypertext updated by kwg 2001-FEB-13