4: Protecting America From Terrorism

Strengthen the FDA's capability to identify, prepare for, and respond to terrorist threats and incidents.

Other Information:

Most of the food safety-related legislative and regulatory changes over the past decade have been aimed at protecting the nation's food supply from hazards that occur both naturally and accidentally in the lengthy farm-to-table food supply chain. But now there is widespread concern that naturally occurring pathogens that could spread easily through the food chain could be used as a bioterrorist weapon. Such an attack would be particularly dangerous for children, the elderly, and those who are immunocompromised. Government officials and food industry observers speculate that the foods most likely to be targets are those that are minimally processed at a central location, and/or are ready-to-eat, such as milk and fresh produce. In addition to the impact on health and safety, bioterrorism against the food supply would also directly harm the U.S. economy. U.S. agriculture contributes $1 trillion to our gross domestic product (GDP) annually and provides 22 percent of all jobs in this country. The food production industry exceeds $200 billion, with over $55 billion worth of products exported each year.22 The production of food is so extensive (most of it comes from 500,000 farms and is handled by 57,000 food processors and 6,000 meat, poultry, and egg product processors) that if even a small number of contaminants were intentionally introduced to some part of the food chain, such an incident could seriously damage public confidence in the safety of the nation's food supply and could result in staggering economic losses for the agriculture industry. The FDA has also been engaged in an accelerated, major new focus on helping to develop and make available better countermeasures for biological, chemical, and radiological attacks. The FDA is going to be critically important in bringing these products to fruition. While the countermeasures that the agency has made available already have given the FDA a deeper and more effective stockpile of treatments than ever, in many cases they are based on old technology. There's strong reason to believe new technology can produce antidotes and vaccines that are even safer and more effective--and so more valuable--than what's available to us now. The FDA plays a central role in the nation's defense against terrorism. The FDA's regulatory authority and responsibility cuts across critical elements in any counterterrorism plan. First, terrorists could use FDA-regulated products, such as imported food, to introduce deadly diseases into the country. Second, FDA-regulated products, such as human and animal drugs, vaccines, blood, and other blood products, would play a central role in countering the effects of terrorism if another attack takes place. It is the FDA's responsibility, working closely with other agencies, the food industry, and the American public, to reduce the chance that an FDA-regulated product is used in an attack. We must ensure that the nation's public health system is able to deter a potential threat and be prepared to respond. On June 12, 2002, the president signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188, H.R. 3448/S. 1765). The bill authorizes $545 million for food protection (out of a total of $2.369 billion for bioterrorism response). The bill contains $130.25 million in appropriations for HHS and requires the FDA to: 1) register food processors and inspect their records, 2) detain adulterated food, and 3) take a number of steps to ensure the safety of imported foods (among other provisions). The agency is now in the process of refocusing its efforts to incorporate enhanced security and safety measures. Far from changing the FDA's 100-year-old mission of consumer protection and public health promotion, the events of Sept. 11, 2001, and the subsequent anthrax attacks and discovery of terrorist activities potentially related to food contamination, have underscored the importance of the FDA's mission. The agency is now in the process of refocusing its efforts to carry out that mission in a changed world. The FDA must have the capability to assess and effectively respond to risks associated with terrorist-related health and safety threats to the U.S. public. The agency's two greatest challenges are to facilitate development of medical countermeasures and to safeguard regulated products. The agency's approach for countering the terrorist threat will involve working with industry to develop medical countermeasures using state-of-the-art science, collaborating with other responding agencies and organizations, strengthening the FDA's own preparedness and response capabilities, and remaining vigilant against potential threats to our nation's health and security. For example, to continue to meet the challenges of protecting the food supply in the face of these new threats, over the coming years the FDA believes the best solution will be the adoption of a risk-based import surveillance system to replace its current import program, and to improve its ability to focus efforts on the highest-risk points in the food supply--points of high risk from both a security and a safety standpoint. For imports, the FDA needs a system that is fully linked with Customs entry processes, and the agency is working closely with the Department of Homeland Security to achieve this. Customs processes have historically been designed to address revenue and trade issues, not public health issues. That's changing. The FDA is moving in the direction of a modern, risk-based system for food imports. The FDA is developing a science-based, "life cycle" approach to assuring the safety of food products. This approach, based on the principles of efficient risk management, will enable the agency to achieve the greatest food protection with its limited resources. For example, when it comes to bulk imports, instead of a taking a snapshot at the border by examining and sampling a particular shipment, the FDA is trying to get a broader picture that covers the product's history from raw materials, through production, transportation to the U.S. manufacturer or producer if there is one, storage, and to the ultimate consumer. The FDA is also considering risk information in deciding how to manage food imports, whether by: 1) working with foreign countries and manufacturers to improve compliance with safe manufacturing abroad as an alternative to detailed inspections at the border, 2) using better information about imports to focus border checks on final products that present significant potential risks, or 3) collaborating with domestic producers to improve checks on the safety of the ingredients they use. We need these creative new strategies to protect America's food supply from deliberate attack. And in many cases, these enhancements to the agency's existing systems for food safety can help us prevent and contain conventional foodborne illness outbreaks. But the FDA must continue to take other efforts aimed specifically at safeguarding our foods against the conventional threats, such as accidental contamination with bacteria and food spoilage. To achieve this goal, the FDA has developed five objectives and strategies.

Objective(s):

4.1: Medical Countermeasures

4.2: Preparedness and Response Capabilities

4.3: Safety at FDA

4.4: Food Supply Safety

4.5: Drugs, Biologics, Medical Devices, Veterinary Drugs, and Other Products

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