Wednesday, July 20, 2005
A great deal has been done in the past few years to enhance the safety of the food supply. FDA has worked with food safety agencies, as well as with law enforcement and intelligence-gathering agencies, and with industry to significantly strengthen the nation's food safety system across the entire distribution chain, from farm to table, to better protect our food supply against deliberate and accidental threats. This cooperation has resulted in greater awareness of vulnerabilities, the creation of more effective prevention programs, new surveillance systems, and faster foodborne illness outbreak response capabilities.
Food safety and food defense continue to be top priorities for this Administration. A terrorist attack on the food supply could have both severe public health and economic consequences, while damaging the public's confidence in the food we eat. The changes in food safety and defense that we have been implementing in the last few years are the most fundamental enhancements in our food safety and defense activities in many years.
In my testimony today, I will first briefly describe FDA's overall role in counterterrorism activities. Then, I will discuss our collaborative activities with our food safety and defense partners. Finally, I will describe some of FDA's counterterrorism activities to enhance protection of the food supply.
FDA's Role in Counterterrorism Activities
FDA's primary mission is to protect the public health. Ensuring that FDA-regulated products are safe and secure is a vital part of that mission. While performing our mission, we play a central and a leadership role in the nation's defense against terrorism. First, terrorists could use an FDA-regulated product, such as food, as a vehicle to introduce biological, chemical, or radiological agents into the U.S. stream of commerce, including the food supply. Second, FDA-regulated products, such as human drugs, vaccines, tissues, blood, blood products, and medical devices, as well as veterinary drugs, will play a central role in preventing or responding to human and/or animal health concerns created by an act of terrorism. It is FDA's goal, working closely within HHS and with other Federal agencies, state and local governments, industry, and the public, to reduce the likelihood that an FDA-regulated product could be used to poison or otherwise terrorize Americans. We also help ensure that the nation's public health system is prepared to deter a potential threat and is ready to respond to an act of terrorism.
By way of background, while FDA has the lead responsibility within HHS for ensuring the safety of food products, the Centers for Disease Control and Prevention (CDC) in HHS has an important complementary public health role. As the lead Federal agency for conducting disease surveillance, CDC monitors the occurrence of illness in the U.S. attributable to the entire food supply. The disease surveillance systems coordinated by CDC provide an essential early-information network to detect dangers in the food supply and to reduce foodborne illness. In addition, these systems can be used to indicate new or changing patterns of foodborne illness. Because CDC also detects and investigates outbreaks of foodborne illness through its networks, CDC is able to alert FDA and USDA about implicated food products associated with foodborne illness and works closely with the agencies to take protective public health action. In keeping with its agency mission, CDC also identifies, evaluates, and provides expert scientific opinion on the effectiveness of foodborne disease prevention strategies.
Collaboration with Food Saftey and Food Defense Partners
FDA's activities in public health defense are coordinated through the HHS Secretary's Operations Center. This relationship facilitates communication between all HHS Operating Divisions, the Department, and other Federal agencies and departments, including DHS. FDA also has worked closely with the Interagency Food Working Group of the White House Homeland Security Council on three initiatives – development of a national network of food laboratories, identification of vulnerabilities and subsequent mitigations for commodities of concern, and the development of a national incident management system.
In addition, FDA's Office of Criminal Investigations (OCI) maintains professional relationships with domestic and foreign law enforcement agencies to receive and act on any information regarding the intentional contamination of FDA-regulated products. OCI has a specialized staff with the clearances, capabilities, and backgrounds to analyze information from law enforcement and intelligence community agencies and to assist those agencies in conducting terrorism-related threat assessments involving FDA-regulated products. OCI serves as FDA's liaison with the intelligence community (CIA, FBI, Defense Intelligence Agency, National Counter-Terrorism Center, and others). In this liaison capacity, OCI maintains relationships and provides expert assistance on scientific, technical, or criminal issues to specialized units within those agencies. OCI field agents serve on selected Joint Terrorism Task Forces around the country and on other multi-agency counterterrorism task forces. OCI agents actively participate in daily briefings at the FBI-led National Joint Terrorism Task Force and at the Department of Homeland Security Information Analysis Infrastructure Protection. FDA also has an OCI agent assigned on a full-time basis to Interpol's office in Washington, D.C. OCI's coordination of the agency's criminal investigative matters, including those that relate to potential acts of terrorism, help to prevent, deter, detect, and interdict a terrorist attack on FDA-regulated products.
FDA is working closely with DHS and other Federal agencies to implement the President's Homeland Security Presidential Directives (HSPDs). The Secretary of DHS is responsible for coordinating the overall national effort to enhance the protection of the critical infrastructure and key resources of the nation, including food and agriculture defense. The President has issued HSPD-7,-8, and–9, which identify critical infrastructures, improve response planning, and establish a national policy to defend the agriculture and food systems against terrorist attacks, major disasters, and other emergencies.
The HHS and USDA Secretaries or their designees exercise key responsibilities as sector-specific agencies. DHS serves as the coordinator of the Food and Agriculture Sector within the Government Coordination Council (GCC). The GCC provides effective coordination of agriculture and food security strategies and activities, policy, and communication across government and between the government and the sector. In addition, the Council also plays a coordination role with the public health and clinical issues resulting from a terrorist act involving the food supply.
Within the GCC, HHS and USDA serve as co-leads for the food sector, and USDA serves as the lead for the agriculture sector. The Food and Agriculture Sector is a public-private partnership that combines expertise from several Federal agencies (FDA, USDA, EPA, Department of Defense [DoD], Department of Commerce, Department of the Interior, and the Department of Justice) as well as that of state and local officials (representing agriculture, public health, and veterinary services), and the private sector (more than 100 trade associations and individual firms participate). As part of the HSPD-7 National Infrastructure Protection Plan (NIPP) development, FDA and USDA have drafted sector-specific plans, which will be finalized after obtaining additional input from states and the private sector. Using these plans as components, DHS has formulated the Interim NIPP for all sectors. The Interim NIPP is now being reviewed by sector members who are obtaining input from industry and state and local government participants. With the close working relationship of FDA and USDA and the other government and industry collaborators, the Food and Agriculture Sector activities to protect critical infrastructure have set the organizational and operational standard for other critical infrastructure sectors. DHS has applauded the Food and Agriculture Sector's organizational structure, consensus building, and the steps it has taken to improve food defense.
FDA also is working closely with our state partners to enhance food defense. For example, during the fall of 2004, FDA issued the Food Security Surveillance Assignment to FDA field personnel and participating state authorities to conduct food defense-related inspections, reconciliation examinations, and collections and analyses of samples of food products that have an elevated risk for intentional contamination. The purpose of this assignment was to deter intentional contamination of food through heightened and targeted preventive activities and to identify and address any gaps in the system for responding to a period of increased food security risk. This assignment enhanced both FDA's and our state counterparts' preparedness for a future threat involving an FDA-regulated product.
Now, I would like to describe some of FDA's other counterterrorism activities.
Implementation of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
Registration of Food Facilities
On October 10, 2003, FDA and CBP jointly published an interim final regulation to implement the registration requirement, which became effective on December 12, 2003. We currently are working to finalize the rule and hope to publish it soon. To date, 261,391 facilities have registered. This includes 114,462 domestic and 146,929 foreign facilities.
Prior Notice of Imported Food Shipments
With the prior notice requirement, specific information mandated by the Bioterrorism Act must be submitted to FDA before the imported food arrives in the U.S. This not only allows FDA's and CBP's electronic screening systems to review and screen the shipments for potential serious threats to health (intentional or otherwise) before food arrives in the U.S., but it also allows FDA staff to review prior notice submissions for those products flagged by the systems as presenting the most significant risk and determine whether the shipment should be held for further investigation. FDA worked very closely with CBP in developing this screening system.
In addition, FDA has been actively working with the analysts at CBP's National Targeting Center to utilize their Automated Targeting System as a supplementary tool to enhance the Agency's ability to focus attention on those imported foods that may pose a serious threat to public health. Products identified as "high risk" through FDA's screening criteria are targeted and undergo a manual, comprehensive "import security review" that includes a review of CBP databases that flag sensitive criminal and terrorist-related information. FDA uses defined risk factors to select candidates for import security reviews, based on intelligence reports and information about the shipper and/or consignee that indicate a potential risk to the U.S. consumer and the domestic market. Prior Notice import security reviews complement the traditional import field examinations. In FY 2004, FDA conducted intensive prior notice import security reviews on 33,111 imported food shipments.
Maintenance and Inspection of Records for Foods
Authority to Commission Other Federal Officials to Conduct Inspections
Industry Guidance and Preventive Measures
To help reduce the risk of an attack on the food supply, FDA and our partners at USDA have joined forces to provide a food security awareness training program entitled, "Protecting the Food Supply from Intentional Adulteration: An Introductory Training Session to Raise Awareness." The training is directed at individuals who play an important role in defending our nation's food from attack: Federal, state, local, and tribal food-industry regulators; school food authorities; and nutrition assistance program operators and administrators. Representatives from the food industry and individuals essential in responding to a food emergency due to an intentional attack ? such as law enforcement, public health, and homeland security officials ? also are encouraged to participate in the training program. The program is available to any interested individuals free of charge.
Vulnerability and Threat Assessments
To validate our findings, FDA contracted with the Institute of Food Technologists to conduct an in-depth review of ORM and provide a critique of its application to food security. This review validated FDA's vulnerability assessment and provided additional information on the public health consequences of a range of scenarios involving various products, agents, and processes.
FDA also contracted with Battelle Memorial Institute to conduct a "Food and Cosmetics, Chemical, Biological, and Radiological Threat Assessment." The assessment also affirmed the findings of FDA's ORM assessment. In addition, it provided another decision-making tool for performing risk assessments. Further, the Battelle assessment made a number of recommendations that addressed research needs, the need for enhanced laboratory capability and capacity, and the need for enhanced partnerships between Federal, state, and local governments to ensure food security. FDA is addressing each of these recommendations.
FDA is continuing to update and refine these assessments regarding the vulnerability of FDA-regulated foods to intentional contamination from biological and chemical agents. These refinements, using a method called CARVER+Shock, use processes adapted from techniques developed by DoD for use in assessing the vulnerabilities of military targets to asymmetric threats. Results of these updated assessments will be used to develop technology interventions and countermeasures, identify research needs, and provide guidance to the private sector.
For example, in 2003, FDA began using the CARVER+Shock analytical tool to perform vulnerability assessments to identify what an individual or group, intent on doing damage to the food and agriculture sector, could potentially do based on their capability, intent, and past history. The CARVER+Shock methodology was modified under Homeland Security Council leadership for use in the food and agriculture sector by FDA, USDA, and DoD with coordination by DHS, CIA, and FBI. FDA's approach has been to seek voluntary, mutually-beneficial partnerships with various segments of the food industry. We have completed such cooperative assessments with four segments of the regulated industry that involve bottled water, fluid dairy products, juice products, and infant formula. FDA is in the process of collaborating and providing technical assistance in assessments to a number of other food product industries using this tool. FDA also has collaborated with USDA to provide assistance to the USDA Food and Nutrition Service on the use of this analytical tool on specific commodities in the school lunch program.
Emergency Preparedness and Response
To enhance FDA's ability to manage, plan for, and respond to food emergencies, FDA has implemented the Emergency Operations Network Incident Management System (EON IMS), an electronic system for managing emergencies. It has three components: incident tracking and contact management, a collaboration and knowledge management tool for meetings and document management, and a Geographic Information System for mapping and impact assessment. The EON IMS is important in all emergencies and exercises requiring efficient receipt and dissemination of large volumes of information to our stakeholders, including the public and other Federal and state agencies. Once completed, this system will provide a web-based connection for all FDA offices and our partners, through which accurate real-time information about various incidents can be shared and discussed. It will be a component of a safety net that enhances our ability to prepare for a terrorist attack and respond should an attack occur. The development of this system conforms to HSPD-5, "Management of Domestic Incidents." The President's FY 2006 budget requests an additional $1.5 million to support this system.
We also are expanding Federal, state, and local involvement in our eLEXNET system by increasing the number of laboratories around the country that participate in this electronic data system. eLEXNET is a seamless, integrated, web-based data exchange system for food testing information that allows multiple agencies engaged in food safety activities to compare, communicate, and coordinate findings of laboratory analyses. It enables health officials to assess risks and analyze trends, and it provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods. At present, there are 113 laboratories representing 50 states and the District of Columbia that are part of the eLEXNET system. We are continuing to increase the number of participating laboratories. Moreover, the governments of Canada, Mexico, and the United States agreed to establish a pilot to use eLEXNET to share food sample data among the three countries' laboratories. FDA has been working with Mexico and Canada to establish a secure network to facilitate the sharing of food-testing data between U.S., Mexican, and Canadian laboratories.
FDA also is collaborating with CDC, USDA, DHS, EPA and many other Federal agencies to create a Memorandum of Agreement for an Integrated Consortium of Laboratory Networks (ICLN). The ICLN will be an integrated system of laboratory networks, such as FERN, to provide for early detection and effective consequence management of acts of terrorism and other events involving a variety of agents and more than one section or segment of the nation (i.e., humans, animals, plants, food, the environment).
In addition, FDA collaborated with the U.S. Department of the Army to design and develop two mobile laboratories to be deployed at borders, ports, or other locations, to enhance our ability to provide timely and efficient analyses of imported food. The construction of these mobile laboratories has been completed, and they are capable of being deployed.
Section 302(d) of the Bioterrorism Act directs FDA to provide for research on tests and sampling methodologies designed to test food to detect adulteration rapidly, particularly methodologies that detect intentional adulteration and tests that are suitable for inspections of food at ports of entry to the United States. This section also requires the Agency to report annually to Congress on its progress. FDA has submitted its second annual report to Congress. It can be found on FDA's Bioterrorism Act webpage.
FDA began redirecting its research program to address food defense concerns soon after the events of September 11, 2001. The report mentioned above describes more than 100 intramural and extramural research projects to develop tests and sampling methodologies for the detection of adulterated food. The Agency's research agenda is particularly focused on methods to detect high-priority biological agents (e.g., Clostridium botulinum neurotoxins) as well as chemical (e.g., ricin), and radiological threat agents that pose the greatest threats to the public and is focused on foods believed to be the most vulnerable or attractive to terrorists. Our researchers also are exploring food-testing protocols using the latest technologies, such as the optical affinity biosensor technology and the quadruple time of flight mass spectrometer, to improve timeliness and accuracy over existing techniques. Researchers are also gleaning information on test methods by using them in studies focused on interventions or shields for the food supply, studies focused on characterizing the behavior (growth, survival, stability) of agents in various food categories, and studies focused on decontaminating food processing facilities.
Among the Agency's research accomplishments are the development, adaptation, or validation of rapid and field-deployable methods to detect various agents in food and the establishment of testing protocols. FDA has shared these new data and technologies with Federal, state, and local entities to equip them to perform food safety testing.
Thank you for this opportunity to discuss FDA's counterterrorism activities to protect the food supply. I would be pleased to respond to any questions.
Last Revised: July 22, 2005