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July 23, 2003
Today the Food and Drug Administration (FDA) submitted to HHS Secretary Tommy G. Thompson a progress report entitled, "Ensuring the Safety and Security of the Nation's Food Supply," which summarizes the leadership demonstrated at FDA in combating the terrorist threat to foods. The events of September 11, 2001, heightened the nation's awareness and placed a renewed focus on ensuring the protection of the nation's critical infrastructures. A terrorist attack on the food supply could pose both severe public health and economic impacts, while damaging the public's confidence in the food we eat.
Although food safety and security are different aspects of food protection, they are inherently connected. FDA, at the direction of HHS, has established a 10-Point Program for ensuring the safety and security of the food supply. Based on activities in FDA's 10-Point Program, the Agency is implementing a comprehensive approach for:
Awareness - develop increased awareness among federal, state, local, and tribal governments and the private sector by collecting, analyzing, and disseminating information and knowledge;
Prevention - develop capacity for identification of a specific threat or attack on the food supply;
Preparedness - develop effective protection strategies to "shield" the food supply from terrorist threats;
Response - develop capacity for rapid, coordinated response to a foodborne terrorist attack; and
Recovery - develop capacity for rapid, coordinated recovery from a foodborne terrorist attack.
Within the food safety and security strategies, FDA's program features 10 areas of focus:
Stronger FDA -- FDA has hired 655 field personnel, 97% of which are allocated for food safety and security field activities. These staff have all been hired, trained and deployed. FDA now has a presence at twice the number of ports it previously did - from 40 to 90. As much more needs to be done, FDA continues to find innovative ways to educate, train our staff and further develop the necessary scientific, technical and investigational skills to integrate food safety and security activities.
Imports -- Strategic Approach. With new staff and focus, we have quintupled the number of food import exams from 12,000 in FY2001 to 62,000 as of today and surpassed our FY 2003 goal of 48,000. As more than 6 million food shipments arrive in the US each year, FDA must do more to target its current resources and set priorities. FDA has developed and continues to refine an Import Strategic Plan (ISP) to provide the critical flexibility and mobility to shift resources as import trends change or events occur.
Bioterrorism Act Regulations. FDA published four major proposed rules: Registration of Food Facilities; Prior Notice of Imported Food Shipments; Administrative Detention; and Records Establishment and Maintenance. In addition, FDA has provided information on the agency's current thinking regarding these proposed rules by conducting an extensive, worldwide outreach program on the proposed rules using satellite telecasts, videoconferences, and embassy briefings, and through collaboration with USDA's Foreign Agriculture Service and the State Department, which have informed many foreign producers and governments throughout the world. FDA is intent to respond to public comments and take steps to make these regulations work efficiently. FDA is on schedule to publish four final regulations later this year.
Industry Guidance and Preventive Measures. FDA has issued five new industry Guidance documents for: (1) food producers, processors, transporters (final); (2) food importers (final); (3) retail food establishments (draft); (4) the cosmetics industry (draft), and (5) fluid milk processors (final). FDA continues to work with industry on awareness of potential threats and improving preventive measures.
Vulnerability and Threat Assessments. FDA has conducted its own assessment of the vulnerability of the U.S. food supply and additionally has commissioned two threat assessments, one through the Battelle Memorial Institute and a second through the Institute of Food Technologists. These assessments are important to direct and focus resources and priorities on the greatest risks.
Operation Liberty Shield. In conjunction with Operation Liberty Shield, FDA ramped up its targeted surveillance of both domestic and imported food as well as coordinated activities and operations with the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS), the Centers for Disease Control and Prevention (CDC) and the states. This approach can be used again during elevated threat levels for a brief time with redirected current food safety resources or long term with additional resources. In addition, FDA's efforts during Operation Liberty Shield prepared its inspection and laboratory staffs to respond to a future threat and/or actual event involving an FDA-regulated product. During the pendency of Operation Liberty Shield, USDA also undertook similar food security measures and activities for its regulated industries including meat, poultry and egg products. Thus, in combination, FDA and USDA comprehensively covered the US food supply.
Emergency Preparedness and Response. FDA has established an Office of Crisis Management (OCM) and has participated in and conducted multiple emergency response exercises that included other federal food safety partners, intelligence agencies, states, and local counterparts. FDA is committed to minimizing the health and terrorism impact on the food supply.
Laboratory Enhancements. FDA redirected laboratory staff to develop analytical methods for priority biological and chemical agents in foods and worked with CDC and their Laboratory Response Network (LRN) to establish a nationwide Food Emergency Response Network (FERN). FERN is a cooperative laboratory network of federal agencies-CDC, FDA, USDA-FSIS, Environmental Protection Agency (EPA), Department of Energy (DOE) and the states. FDA will work with CDC and states to improve laboratory capacity to enhance response capability for food security concerns. With CDC grant funds, states are initiating additional activities to increase lab capacity for food related emergencies.
Research. FDA recently received $5 million for research efforts. The FDA plans to focus this new food security research thrust on the development of prevention and mitigation technologies and strategies. The nation's food defense programs are now maturing into a new phase, wherein the ability to respond rapidly is being integrated with the development of strategies for preventing or deterring the use of foods as a vehicle for terror. FDA is laying out a new type of public health research agenda that integrates food safety and security. FDA has significantly increased both its internal and extramural efforts to determine stability and detection of terrorist agents in foods; new detection technologies and methods; prevention and intervention technologies to reduce the potential threat to the food supply. While FDA collaborates with many other federal research agencies [e.g. National Institutes of Health (NIH), CDC, Department of Defense (DOD), and USDA's Agriculture Research Service], FDA serves an important and unique research role in food safety and security not filled by other research organizations and therefore require additional resources to fully realize the public health research agenda goals.
Interagency Communication and Collaboration. FDA works closely with agencies within the Department of Health and Human Services (HHS), namely NIH and CDC; our federal food safety and security partners, USDA-FSIS, EPA, Department of Homeland Security, White House Homeland Security Council, DHS, and DOD; as well as federal law enforcement agencies such as the Federal Bureau of Investigation (FBI) and the Central Intelligence Agency (CIA); and State and local governments. FDA works particularly closely with the Food Safety Inspection Service of USDA, recognizing that Agency's legal responsibility over the safety and security of meat, poultry and egg products. FDA participates in a number of interagency workgroups to foster better coordination, communication, and leveraging resources to improve food safety and security.
FDA remains dedicated to ensuring the safety and security of the nation's food supply and will continue to do all we can to fulfill this critical mission.
