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FDA Significantly Expands Food GMPs in New White Paper

Nov 07, 2005

FDA Significantly Expands Food GMPs in New White Paper

IDFA Reactivates Member Task Force to Review Document

On November 2, the Food and Drug Administration (FDA) released a white paper that explains its current thinking on how the agency will be revising the Good Manufacturing Practices (GMPs) for food, which are wide-ranging rules governing nearly all aspects of food manufacturing and processing systems. FDA is now accepting public comments on the document; once the agency reviews public input, it is then expected to move forward with formal rulemaking in order to finalize changes.

Given the importance of analyzing the FDA's proposed changes and their possible effects on dairy processors, IDFA has activated its member task force on GMPs that was created last year when the agency signaled that it would be modifying these rules. This group will be crafting IDFA's comments for submission to FDA.

"We're calling for broad participation by dairy companies in this crucial review of the GMP white paper," said Allen Sayler, IDFA senior director of regulatory affairs. "This comment period offers a rare chance to offer input on a formative step in FDA's rulemaking process."

While still reviewing the lengthy document, Sayler noted that several of FDA's "modernization opportunities" listed in the Executive Summary could, if enacted, result in extensive new regulations for processors. The agency's key proposals include:

To require companies to provide and document training for supervisors and workers in the areas of food hygiene, food protection, employee health and personal hygiene.

To require food processors that produce foods with any of the eight major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat or soybeans) to have a written food allergen control plan that meets FDA's standards.

To require a written environmental pathogen control program from processors of ready-to-eat foods (which would likely include most dairy products) that support the growth of Listeria monocytogenes.

To require food processors to develop and maintain a written sanitation procedures plan that at a minimum covers food processing equipment.

To require food companies to maintain critical records on the new requirements listed above, and to offer those records for inspection by FDA investigators.

To review FDA's full white paper on food GMPs, click here to visit the agency's website. To participate in the IDFA review of the document, contact Allen Sayler at, 202/220-3544.

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Posted November 7, 2005

Dairy Delivers