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FDA Proposal Aims to Prevent Intentional Contamination of Food Supply

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WASHINGTONFood companies would need to take measures to protect their facilities from intentional attempts to contaminate the food supply under a rule that has been proposed by the U.S. Food and Drug Administration (FDA).

The plan, issued under the nearly 3-year-old Food Safety Modernization Act (FSMA) and more than 12 years after the deadliest terrorist attack on U.S. soil, calls for a food facility to develop a written food defense plan that tackles large vulnerabilities in the food production process.

FDA said facilities would be required to identify and implement strategies to address weak areas, establish monitoring procedures and corrective actions and ensure the system is functioning. The proposal also includes recordkeeping requirements and a mandate that personnel assigned to vulnerable areas are properly trained.

This is the first time FDA has proposed a rule for preventing intentional adulteration of the food supply and marks the sixth proposal issued this year under a comprehensive law that is intended to prevent incidents of foodborne illness like the recent Salmonella outbreak tied to Foster Farms poultry. Congress imposed aggressive timelines under FSMA, and FDA has cited the complexity of carrying out the statute's myriad mandates as a reason for missing a number of deadlines.

FDA is unaware of an intentional attempt to adulterate the U.S. food supply with the objective of causing widespread harm to the public. Still, the agency said the strategies outlined in the proposal can help ensure food is safe. The agency previously developed guidance and other tools to help the food industry protect itself from intentional adulteration following the terrorist attacks on Sept. 11, 2011 and the subsequent passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

"The goal is to protect the food supply from those who may attempt to cause large-scale public health harm," said Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine, in a statement. "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 practice, cost-effective manner.

The rule would not apply to farms and food for animals and it includes exemptions based on the size of the business, sales and certain types of operations such as holding and repacking food, with certain exceptions.  FDA has proposed staggered implementation dates for the rule based on the size of a business ranging from one year to three years after the rule is published. The public can comment on the proposal until March 31, 2014.

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