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FDA Update - FDA sets forth a Seafood HACCP Transition Guidance

In a Fed. Reg. Announcement, March 26th, 1999, (docket # 99D-0392), the FDA is issuing for comment a draft guidance setting forth circumstances under which the agency may consider retaining from regulatory action under the seafood Hazard Analysis Critical Control Point (HACCP) regulations, pending completion of studies to resolve scientific issues relating to whether the agency should revise or amend its policies concerning particular hazard analyses or controls.

It appears that the FDA is having giving second thought to the fact that they have been using the HACCP manuals as a regulatory document not just a guidance document. Processors may control hazards in other ways so long as they can demonstrate that their approaches are scientifically defensible. Processors may also rely on hazard analyses that differ from those in the Guides so long as they can demonstrate that their own analyses are valid for their particular circumstance.

As a general matter, processors should establish the adequacy of a hazard analysis or control before implementing it. FDA can envision circumstances, have, where the industry could make a strong threshold case for the validity of a particular hazard analysis or system of controls even though complete confirmation of its validity was not yet available from scientific studies.

FDA believes that a mandatory HACCP program should serve as a catalyst for research and science-based resolution of food safety questions. Thus, where the consuming public would not be at risk, FDA believes it is appropriate to use a mechanism that encourages the resolution of legitimate scientific questions before they become legal controversies.

Under these circumstance the FDA evaluate information submitted as appropriate: (1) the methodology of the scientific study; (2) the scientific merit of the conclusions, and (3) the consistency of the recommended action with agency policy.

Any changes in agency position will be posted on FDA's Internet website at www.fda.gov and then reflected in the next edition of the Guide.

For more information go the FDA website or contact mdi Consultants.

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