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IDFA Urges FDA to Maintain Flexibility in Dairy Plant Safety Programs

Aug 28, 2006

IDFA Urges FDA to Maintain Flexibility in Dairy Plant Safety Programs

IDFA submitted comments to the Food and Drug Administration (FDA) last week in response to the agency's white paper that examines possible revisions to the current Good Manufacturing Practices (GMPs) for food (21 CFR 110). Emphasizing that flexibility is crucial, IDFA's comments support FDA's efforts to update the existing regulations to cover new food safety and technology issues that are not currently included.

IDFA and its 50-member task force on GMPs crafted IDFA's comments in response to the wide-ranging white paper. FDA released the white paper last November on ways to modernize the current food GMPs, which are rules governing nearly all aspects of food manufacturing and processing systems. FDA has accepted public comments on the document without a deadline. Once the agency gathers and reviews sufficient public input, FDA plans to move forward with formal rulemaking to finalize the changes.

In its comments, IDFA addressed proposed revisions in record retention and FDA records access, environmental monitoring of Listeria monocytogenes, food allergen management, employee GMP training, processing equipment sanitation programs and product temperature monitoring.

While IDFA believes that dairy product manufacturers should maintain records that demonstrate their adherence to the GMPs, it said that FDA access to processing and operational records should not be expanded and that no need exists for the agency to develop detailed criteria for evaluating manufacturers' GMP records.

"Establishing detailed criteria to evaluate such records would run counter to records development flexibility, since the record needs for two different food processing plants are not the same," the comments state.

IDFA also supports a science-based and written, yet flexible, plan for processors of ready-to-eat foods to monitor the production environment for Listeria monocytogenes. The comments clarify that certain foods do not support the growth of Listeria monocytogenes and should be excluded from the monitoring plan. These foods include aseptically processed and packaged foods as well as designated "non-potentially hazardous" foods, such as ice cream and certain hard cheeses.

IDFA fully supports the recommended requirement of a written food allergen management program to address processing issues, cross-contact during storage, and supplier participation and responsibility. The comments add, however, that processors must have the flexibility to design their own plans to meet the varying requirements of each company.

Employee and supervisory training combined with appropriate cleaning, storage and handling procedures can greatly enhance the effectiveness of a company's allergen management program, IDFA states, agreeing with the white paper's recommendations. The comments add that specific training and procedural guidelines should be developed by individual manufacturers, because each company's needs vary considerably.

"The regulatory flexibility in the existing GMPs has allowed these regulations to be effective 20 years after implementation, and this flexibility needs to be maintained in any new language," the comments state.

Although they also were very involved in a food industry coalition that previously submitted comments, IDFA and the task force decided to submit additional comments to address the white paper recommendations specifically from the dairy processor's perspective.

"This open comment period has given IDFA and the dairy industry an excellent opportunity to rigorously study the proposed modernizations, and to offer constructive comments to FDA's anticipated GMP rulemaking process by identifying necessary updates while also preserving the rights and responsibility of dairy processors," said Allen Sayler, IDFA senior director of regulatory affairs.

To read IDFA's comments in full, click here. To read FDA's white paper, click here.

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Posted August 28, 2006

Dairy Delivers