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Preventing Intentional Adulteration of Food is Aim of FDA Proposal

Monday, December 23, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration issued Dec. 20 a proposed rule that would require the largest food businesses in the U.S. and abroad to take steps to prevent facilities from being the target of intentional attempts to contaminate the food supply. Under this proposal, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process. Facilities then would have to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.

FDA states that the proposed rule targets certain processes within a facility that are most likely to be vulnerable rather than targeting specific foods or hazards. FDA has identified four key activities within the food system that are most vulnerable: bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and mixing and similar activities.

With some exceptions, this rule would apply to both domestic and foreign facilities that manufacture, process, pack or hold food and are required to register as a food facility. The proposed requirements would be effective 60 days after a final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply, FDA is proposing tiered compliance dates based on facility size. FDA also plans to publish a guidance document for small businesses within six months of publication of the final rule.

Comments on this rule are being accepted through March 31. In addition, FDA will hold a public meeting on this proposal Feb. 20 in College Park, Md., and is considering additional public meetings or other public engagement opportunities.

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