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FDA Issues Final Food Defense Regulation
USAgNet - 05/31/2016

The U.S. Food and Drug Administration finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.

The FDA is committed to working with both industry and its state, local and tribal partners to ensure effective implementation of this new rule. Implementation of the Intentional Adulteration rule and all FSMA final rules will require partnership, education, and training. The FDA and others will provide industry with valuable tools to make compliance with the final rules easier, such as guidances, training courses and a technical assistance center.

Food manufacturers are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the business.


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