FDA proposes new food defense rule

As required by the bipartisan FDA 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 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 goal is to protect the food supply from those who may attempt to cause large-scale public health harm,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “Such events, while unlikely to occur, must be taken seriously because they have the potential to cause serious public health and economic consequences. The FDA’s goal is to devise an approach that effectively protects the food supply in a practical, cost effective manner.”

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.

The FDA has proposed exemptions to the rule based on size of business, sales and certain types of operations such as holding and repacking food, with certain exceptions. 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 is seeking comments on its evaluation of what the agency considers to be low-risk activities for intentional contamination at farm mixed-type facilities, with a specific focus on the risk presented by acts of terrorism.

The FDA is proposing staggered implementation dates for the proposed rule based on business size, ranging from one year to three years after publication of the final rule. The proposed rule is available for public comment until March 31, 2014.

For more information:

• Federal Register Notice for the Proposed Rule “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration”
• FDA Food Safety Modernization Act (FSMA)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.