FDA Announces Modernization of Food Good Manufacturing Practices

May 6--In a speech to the National Food Policy Conference, Food and Drug Administration acting Commissioner, Dr. Lester M. Crawford, announced today 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.


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