FDA proposed food defence rule

The largest US food processors could be obliged to take action to prevent large-scale food adulteration under the new food defence rule proposed by the US Food and Drug Administration (FDA).

While the FDA acknowledges that no attempts thus far have been made to contaminate the food supply with the goal of inflicting large-scale public health harm, it says the rule is intended as a preventive measure.

The proposed rule is the sixth issued under the FDA Food Safety Modernization Act (FSMA) in 2013. The rule would apply to all goods produced in and imported to the US.

“The goal is to protect the food supply from those who may attempt to cause large-scale public health harm,” said Michael R Taylor, FDA 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 has proposed that the rule focus on specific processes within a food facility that are most vulnerable to attack. Under the rule, a food facility would be required to:

• keep a written food defence plan that identifies vulnerabilities in its food production processes,
• implement strategies to address these vulnerabilities,
• establish monitoring procedures and corrective actions,
• verify that the system is working,
• ensure that personnel assigned to vulnerable areas receive training and maintain records.

This is the first time the FDA has proposed a regulatory approach for preventing intentional adulteration of the food supply. It is seeking public input to refine its approach and focus the scope of the rule.

The FDA has proposed exemptions to the rule based on the size of a business. Certain types of operations such as holding and repacking food would be exempted, with some exceptions. The proposed rule does not apply to farms or food for animals.

The FDA is proposing staggered implementation dates for the proposed rule based on business size, ranging from one to three years after publication of the final rule.

The proposed rule is available for public comment until 31 March 2014.

More information about the proposed rule is available here.