FDA proposes new food defense rule

by Sabrina I. Pacifici on December 22, 2013

Proposed rule marks the 6th issued under FDA Food Safety Modernization Act this year: “As required by the bipartisan FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration proposed a rule [Focused Mitigation Strategies to Protect Food Against Intentional Adulteration] that would require the largest food businesses in the United States and abroad to take steps to prevent facilities from being the target of intentional attempts to contaminate the food supply. The FDA is unaware of an event where the food supply was adulterated with the goal of inflicting massive public health harm. While such events are unlikely to occur, mitigating strategies proposed in the rule can continue to ensure the safety of the food supply. The proposed rule is intended as a preventive measure, and the FDA seeks public comment on the proposed approach. The proposed rule is the sixth issued under the landmark FDA FSMA law, which focuses on prevention and addresses the safety of foods that are produced domestically or are imported to the United States. The FDA is proposing a targeted approach focused on certain processes within a food facility that are most likely to be vulnerable to attack. 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. This is the first time the FDA has proposed a regulatory approach for preventing intentional adulteration of the food supply, and the agency is seeking public input to refine our approach and further focus the scope of the rule. Since Sept. 11, 2001, and the subsequent passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the FDA has developed a variety of guidances and other tools to help industry protect the food supply against intentional adulteration. This rule builds on those efforts, as well as the steps industry has taken.”

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