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
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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
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