U.S. FDA Announces Plans to Modernize Food GMPs

From: Pamela Tom (pdtom@ucdavis.edu)
Date: Mon May 10 2004 - 17:29:48 PDT

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    Fr: Pamela Tom, University of California, Sea Grant Extension Program

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    In a speech to the National Food Policy Conference, Food and Drug
    Administration acting Commissioner, Dr. Lester M. Crawford, announced on
    May 6, 2004 the agency's plans and processes for modernizing the good
    manufacturing practices (GMPS) used for foods.

    Since the food GMPs were last revised in 1986, there have been significant
    changes in food production technology, as well as a better understanding
    of foodborne illnesses.

    "Since food GMPs are an integral part of the nation's control over food
    safety problems it is essential that they adequately address the needs of
    today's food processes and foodborne hazards," said Dr. Crawford. "We
    believe this effort, like our work on current good manufacturing practices
    for medical products, will improve the safety of these products and create
    new opportunities for introducing better manufacturing techniques."

    In order to evaluate its current food GMPs, the FDA established an
    internal Food GMP Modernization Working Group in July 2002. The Working
    Group initiated further research in two areas: (1) the impact of the food
    GMPs on food safety and (2) the impact of revised regulations on food
    safety and the likely economic consequences of such revisions.

    The research effort includes several components, including, among other
    things, a literature review, and soliciting of expert opinions.

    The agency plans to hold three public meetings this summer to receive
    data, information, and other input on food GMP modernization from
    stakeholders. The meetings will be held in College Park, MD., and Chicago,
    ILL., with a third one yet to be determined and will include outreach to
    small businesses.

    FDA will announce the meetings shortly in the Federal Register (FR). To
    help focus the public meeting comments, the FR notice will include a list
    of specific questions about food GMP modernization that FDA would like
    participants to address.

    The FDA will evaluate the data and information received to determine how
    to revise the food GMP regulations. FDA plans to publish a white paper
    with a summary of its findings in September. FDA will then proceed through
    (notice-and-comment) rulemaking, as appropriate.

    FDA is developing a final rule to establish GMPs for dietary supplements.
    The agency will continue to coordinate any possible future revisions to
    the food GMPs with dietary supplement GMPs.

    Source: http://www.fda.gov/bbs/topics/news/2004/NEW01063.html



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