US FDA issues final food-defense regulation
June 7, 2016

THE United States Food and Drug Administration has finalized a new food-safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA), which  will help prevent wide-scale public-health harm by requiring companies in the US 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, and ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, MD, incoming deputy commissioner for foods and veterinary medicine, FDA. “The rule will work in concert with other components of FSMA by preventing food-safety problems before they occur.”

Food manufacturers are required to comply with the new regulation within three years to five years after publication of the final rule, depending on the size of the business. The FDA has now finalized all seven major rules that implement the core of FSMA. The Intentional Adulteration final rule builds on the Preventive Controls rules for human food and animal food, the Produce Safety rule, Foreign Supplier Verification Program rule, Accreditation of Third-Party Certification rule and the rule on Sanitary Transportation of Human and Animal Food. These seven rules will work together to systemically strengthen the food-safety system and better protect public health. □

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