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New FDA Requirements on Food Safety Elevate Allergen Controls

New regulations released last week from the Food and Drug Administration (FDA) now include several provisions related to food “allergen cross-contact” that elevate the importance of allergen management in the manufacturing environment.

The new additions to the “Current Good Manufacturing Practices,” a regulation that has existed since 1986, signal increased recognition by the FDA, the nation’s most important regulatory agency for food safety, that the presence of unintended food allergens is a problem that needs to be avoided and addressed by food companies.

FARE provided data and feedback to FDA officials throughout their deliberation process, which began more than two years ago. The new regulations were developed as a result of the passage of the Food Safety Modernization Act (FSMA), which was signed into law in January 2011. This is a major food safety amendment to the federal Food, Drug and Cosmetic Act. The purpose of the law is to put much more emphasis on preventing all types of food safety problems. FSMA includes provisions intended to prevent the inadvertent presence of food allergens in most foods that are sold in grocery stores.

FSMA required FDA to develop several new regulations to implement the new requirements, including the final rule identified as “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Those new regulations were published in the Federal Register last week. Food industry members will begin compliance process within a year. Full compliance with all requirements will take several years.

Included in the new regulations is the creation of a new set of “preventive controls” requirements that are intended to systematically prevent food safety problems. Although the preventive controls provisions have a strong focus on preventing the presence of pathogens in food, the new regulation also includes important food allergen controls.

While previously the FDA urged manufacturers to be careful to avoid the unintended presence of allergens in foods, now the industry is required to avoid the unintended presence of allergens in foods through a series of specific preventive controls.  If they don’t follow these controls, the food will be considered adulterated and misbranded by the FDA and subject to new enforcement tools, including the authority to mandate recalls for unsafe food (recalls in the past have been voluntary).

Food companies are now required to keep records for each preventive control step (including food allergen preventive controls). Those records must be accurate and must be made available to the FDA upon request. Access to the required food safety records will help the FDA identify companies that have not implemented preventive control protocols.

You may read more about the FDA’s final rule for preventive controls, including requirements and compliance, here.

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