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FDA Proposes New Food Defense Rule under FSMA to Address Intentional Adulteration of Food

CFSAN Constituent Update

December 20, 2013

As required by the bipartisan Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a 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. The proposed rule is the sixth issued under the landmark FDA Food Safety Modernization Act (FSMA), which focuses on prevention and addresses the safety of foods that are produced domestically or are imported to the United States.

Under the proposed rule, 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.

The proposed rule does not apply to farms and food for animals. Also in the proposed rule, the FDA describes its current thinking and is seeking comment on other issues, including economically motivated adulteration.

The FDA will hold a public meeting on February 20, 2014 in College Park, MD. The FDA will conduct additional outreach during the comment period, which may include additional public meetings.

The proposed rule is available for public comment until March 31, 2014.

For more information:

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