FDA issues draft guidelines to protect food products from deliberate attacks

Intentional adulteration (IA) can take several forms: acts intended to cause wide-scale public health harm (such as terrorism) focused on the food supply; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration (EMA).  The first type of act is the center of the regulation because it is intended to cause wide-scale public health harm with intent to cause significant human morbidity and mortality.

The U.S. Food and Drug Administration released today a revised draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry,” to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA).

This is the second installment of the FDA draft. It outlines methods for how facilities can conduct vulnerability assessments to identify their areas of highest risk and provides information about requirements for education and training. The FDA also intends to provide the third installment of this draft guidance that will include additional information on corrective actions, verification, records maintenance, reanalysis requirements, and how to calculate small and very small business sizes in order to determine what requirements of the rules are applicable.

The FDA Commissioner Scott Gottlieb, M.D said: “We’ve taken steps to minimize the risk of an intentional attack on our food supply, and today we’re advancing new steps to help manufacturers implement additional activities that can help identify and mitigate the risk of intentional food adulteration.” “This is a serious issue that warrants serious attention and that is why today we’re taking some additional steps to help ensure that food facilities will implement the rule as effectively as possible,”

The IA rule requires certain facilities – both domestic facilities and foreign facilities that export to the U.S. – to develop and implement a food defense plan that assesses their potential vulnerabilities to such acts of deliberate contamination.