FDA's Seafood HACCP Program: Mid-Course Correction

From: Pamela Tom (pdtom@ucdavis.edu)
Date: Thu Feb 15 2001 - 15:06:14 PST

  • Next message: Pamela Tom: "Job Vacancy: Public Health Advisor with the Interstate Shellfish Sanitation Conference (Contract Position)"

    The following information is FDA's response to the GAO report on Safety
    that was posted via this listserv yesterday.

    Pamela Tom, University of California Sea Grant Extension Program
    ==========================================================================
    FDA's Seafood HACCP Program: Mid-Course Correction

    Introduction: The General Accounting Office (GAO) has released a report
    evaluating FDAs 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 FDAs 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.
    FDAs 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.

    FDA has made substantial progress in ensuring the safety of seafood
    consumed by the public . . .

    - 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: FDAs 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. FDAs 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 FDAs 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.

    ... But Some Firms Lag Behind

    - 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 Institutes a Mid-Course Correction to Focus on Highest Risk

    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:

            a.those firms that need to control for pathogens;
            b.those firms that need to control for histamines (these can cause
              allergic reactions); and
            c.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

    Web source: http://www.cfsan.fda.gov/~comm/shaccp1.html

    --------------------------------------------------------------
    This is the Seafood HACCP Discussion Group. Information is
    available on the web at:
    http://seafood.ucdavis.edu/listserv/Listserv.htm
    For inquiries on subscribing to the list, e-mail: pdtom@ucdavis.edu

    To subscribe, e-mail listproc@ucdavis.edu with the message:
    subscribe seafood [your first name] [your last name]
    To unsubscribe, e-mmail listproc@ucdavis.edu with the message:
    unsubscribe seafood

    Files are now archived at:
    http://listproc.ucdavis.edu/archives/seafood/
    --------------------------------------------------------------



    This archive was generated by hypermail 2b29 : Thu Feb 15 2001 - 15:07:34 PST