Counterterrorism: Protecting America from Terrorism

Counterterrorism is one of five initiatives established for FDA to address five critical challenges facing the agency.

The counterterrorism initiative focuses on the Agency's responsibilities to quickly respond to terrorism and to enhance food security. FDA will assist in countering the terrorism threat by: 1) preparing for the possibility of attacks on the U.S. population through a strengthened product monitoring infrastructure and emergency preparedness plans; and 2) responding rapidly and appropriately in the event of an actual attack with effective medical countermeasures and product disposal actions.

The following is an excerpt describing this initiative from FDA's Strategic Plan:

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.

Protecting America From Terrorism: FDA's Objectives

Objective 1. Facilitate the development and availability of medical countermeasures to limit the effects of a terrorist attack on the civilian or military populations.

Medical products (human and animal drugs, vaccines and other biological products, blood and blood products, medical devices) must be readily available to prevent, diagnose, and treat illnesses resulting from a terrorist attack. In addition, specialized products could be needed for certain groups, such as military personnel, first responders to emergencies, residents near nuclear facilities, pregnant women, immunocompromised persons, and children.

Objective 2. Enhance the agency's emergency preparedness and response capabilities to be better able to respond in the event of a terrorist attack.

To respond effectively to terrorism-related emergencies and crises, the FDA must be prepared for a wide range of circumstances and contingencies. Many types of emergencies could require the FDA's assistance. Reaching a new level of readiness for terrorist attacks will involve several key action items.

Objective 3. Ensure the safety and security of FDA personnel, physical assets, and sensitive information.

• Ensure the proper level of personnel background security investigations are conducted.
• Enhance the physical security of FDA facilities.
• Develop a Continuity of Operations Plan (COOP) to continue mission-critical functions.
• Educate and train appropriate personnel on the handling and dissemination of sensitive information.

Objective 4. The FDA must uphold its responsibility for ensuring the safety of approximately 80 percent of the nation's food supply. The possibility of food products being used as a vehicle for attack is particularly worrisome because such an event potentially affects everyone in the United States. The FDA must have the capability to assess and then reduce risks associated with unexpected and potentially widespread health and safety threats.

Objective 5. Protect the safety and security of human drugs, biologics (vaccines, blood and blood products, gene therapy, human tissues, and cellular therapies), medical devices (including radiation-emitting and screening devices), veterinary drugs, and other FDA-regulated products.

• Implement the applicable provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
• Participate in the completion of a thorough review of areas of alleged vulnerability to identify those areas of highest safety and security concerns.
• Develop and implement preventive strategies to address the highest-priority vulnerabilities.

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Footnote

²²Food Safety and Protection Issues in the 107th Congress, August 2002, Congressional Research Service.

Complete FDA Strategic Plan