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Director of the FDA Center for Food Safety and Applied Nutrition’s (CFSAN’s) Office of Food Safety, Defense, and Outreach. Where comprehensive source materials were unavailable, the discussion relies on anecdotal information and inferences from program directives.


“Food defense” is the collective term used by the FDA, the U.S. Department of Agriculture (USDA), the U.S. Department of Homeland Security (DHS), and others to describe activities associated with protecting the nation’s food supply from deliberate acts of contamination. Shortly after September 11, 2001, the FDA and other federal agencies began developing a new program, building on a program initiated by the U.S. Department of Health and Human Services (HHS), to protect the nation’s food supply from terrorist attacks. The FDA focused its efforts on targeted industry guidance and outreach, inspections, research (e.g., methods development and validation, characteristics and behavior of agents in foods, pathogenicity/toxicity in foods), and mitigation strategies to reduce potential risks in the food supply. Numerous organizations, public and private, have played a role in the FDA’s food defense program to date (see Annex Table D-1).

The FDA used operational risk management (ORM) as a tool to identify food defense priorities. ORM is a management tool used by the U.S. Departments of Defense (DoD) and Transportation to identify risks and reduce them to an appropriate level, ensuring that benefits will outweigh any risks. It is an analytical tool whereby severity and probability (accessibility) of risk are measured qualitatively and assigned a rating—high, medium, or low (see Table D-1).

A CFSAN team of scientific and food production experts was charged with testing the tool on a list of threat agents, starting with the list of the U.S. Centers for Disease Control and Prevention (CDC) and expanded to other known or potential threat agents, in combination with a list of FDA-regulated foods. The class groupings were, for example, heat-labile bacterial toxins, heat-stable bacterial toxins, and spore-forming bacteria. The agents (surrogates) were also assessed on their accessibility, public health impact (morbidity and mortality), toxicity/pathogenicity, dose required to cause intended outcome, agent–food compatibility, ability to withstand processing, and changes to sensory attributes of food. (The resulting list of prioritized agent–food combinations is classified and unavailable for this discussion.) This risk assessment effort, early in the evolution of the food defense program, was crucial to identifying a finite list of agent–food combinations for further investigation and helped in understanding the potential hazards. Equipped with this risk assessment tool, the FDA focused

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