Monday, January 9, 2006
The events of September and October 2001 made it very clear that terrorism -indeed bioterrorism - is a serious threat to our Nation and the world. The Bush Administration and Congress responded forcefully to this threat by providing funding to strengthen our medical and public health capacities to protect our citizens from future attacks.
A great deal has been done in the past few years to enhance the safety and security of the food supply in the United States. Within HHS, the Food and Drug Administration (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 and security 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. HHS's Centers for Disease Control and Prevention (CDC) maintains national surveillance for specific infections and for outbreaks of foodborne illnesses, supports states in investigating and controlling outbreaks, and maintains cross-communication with FDA and USDA.
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 HHS' overall role in counterterrorism activities. Then, I will discuss our collaborative activities with our food safety and defense partners. I will also describe some of FDA's counterterrorism activities to enhance protection of the food supply. Finally, I will briefly discuss some of our efforts with regard to avian influenza.
HHS' Role In Counterterrirism Activities
Principally through HHS's Centers for Disease Control and Prevention (CDC) and Health Resources and Services Administration (HRSA), funds have been provided to States and localities to upgrade infectious disease surveillance and investigation, enhance the readiness of hospitals and the health care system to deal with large numbers of casualties, expand public health laboratory and communications capacities and improve connectivity between hospitals, and city, local and state health departments to enhance disease reporting.
CDC also operates HHS's Strategic National Stockpile (SNS), which contains large quantities of medicine and medical supplies to protect the American public if there is a public health emergency severe enough to cause local supplies to run out. Once Federal and local authorities agree that the SNS is needed, medicines will be delivered to any state in the U.S. within 12 hours. Consequently, each state is now required to develop plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible in the event of a deployment.
HHS's National Institutes of Health (NIH) is assigned the lead role in the development of medical countermeasures to biological attack, and in the conduct of research concerning potential agents of bioterrorism that directly affect human health. The National Institute of Allergy and Infectious Diseases (NIAID) is the NIH institute with primary responsibility for carrying out this assignment.
To further encourage the development of new medical countermeasures against chemical, biological, radiological and nuclear agents and to speed their delivery and use should there be an attack, President Bush, in his 2003 State of the Union address proposed and Congress subsequently enacted Project BioShield to assure developers of medical countermeasures that funds would be available to purchase these critical products for use to protect our citizens. Project Bioshield is operated out of the HHS Office of Public Health Emergency Preparedness, which also coordinates the HHS-wide emergency preparedness activities and serves as the principal point of contact at HHS for other Federal agencies and Departments.
FDA is the Federal agency that regulates everything we eat except for meat, poultry, and processed egg products, which are regulated by our partners at USDA. FDA's responsibility extends to live food animals and animal feed. FDA also is responsible for ensuring that human drugs, human biological products, medical devices, and radiological products as well as veterinary drugs are safe and effective and that cosmetics are safe. In addition, FDA is responsible for ensuring that the health consequences of foods and medicines are accurately and honestly represented to the public, so that they can be used as effectively as possible to protect and improve the public health.
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. 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 HHS's goal, with FDA working closely with other HHS agencies and other Federal agencies, and with 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, although FDA has the lead responsibility within HHS for ensuring the safety of food products, the CDC 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 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 among 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 worked in partnership with the U.S. Environmental Protection Agency, USDA, DHS, and the Department of Defense to describe general Federal roles responsibilities for decontamination and disposal in response to animals, crop, and food incidents.
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. HSPD-9 calls for the development of a National Veterinary Stockpile (NVS). FDA and CDC participate in NVS Steering Committee activities.
The HHS and USDA Secretaries or their designees exercise key responsibilities as food sector-specific agencies. DHS serves as the coordinator of the Food and Agriculture Sector within the Government Coordination Council (GCC). The GCC is charged with coordinating agriculture and food security strategies and activities, policy, and communication across government and between the government and the sector. In addition, the Council plays a coordinating 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 revised after obtaining additional input from states and the private sector. Using these plans as components, DHS has formulated the Interim NIPP for all sectors. 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. Since that time, FDA has issued and completed three additional assignments to further integrate our food defense activities into our food safety work.
In addition, FDA and CDC have been collaborating with a Council of Association Presidents to develop a nationwide food defense awareness training program. This Council, which consists of ten of the major state and local public health and regulatory professional associations, has an outreach capability to reach virtually all state and local public health officials. The training program will help raise food defense awareness at the local, state, and Federal levels.
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 rule to implement the registration requirement, which became effective on December 12, 2003, as required by the Bioterrorism Act. The registration interim final rule was effective immediately but provided an opportunity for public comment on specific issues. On October 3, 2005, FDA issued the Registration of Food Facilities Final Rule, which affirmed the requirements initially set forth in the interim final rule. As of December 2, 2005, approximately 271,000 facilities have registered with FDA. This includes about 116,000 domestic and about 155,000 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.
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. This allows FDA to screen products against CBP databases containing sensitive criminal and terrorist-related information. Products identified as potentially "high risk" through FDA's and CBP's screening criteria are targeted and undergo a manual, comprehensive "import security review" by FDA's Prior Notice Center that operates 24 hours a day, 7 days a week, every day of the year. FDA uses defined risk factors to select the products 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 2005, FDA conducted intensive prior notice import security reviews on 86,187 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.
The ORM approach provided a high-level view of foods and agents that were of greater concern. Since the completion of the ORM, FDA has undertaken more in-depth vulnerability assessments of specific food commodities using a method called CARVER+Shock. This method uses processes adapted from techniques developed by DoD for use in assessing the vulnerabilities of military targets to asymmetric threats. Results of these updated assessments are being used to develop technology interventions and countermeasures, identify research needs, and provide guidance to the private sector.
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 the person's or group's 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 segments of the regulated industry that involve bottled water, fluid dairy products, juice products, and infant formula. 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.
In recent months, FDA has been part of a joint federal initiative along with USDA, DHS, and the FBI called the Strategic Partnership Program in Agroterrorism (SPPA). The SPPA initiative is again using the CARVER+Shock tool but, by seeking industry and state volunteers, is taking the tool to local venues. During these assessments, there are local industry, FBI, DHS, FDA, and USDA participants. These assessments not only identify vulnerabilities in other food commodities but also build local infrastructure around food defense issues. The SPPA program will run for two years and has a goal of completing 40-50 assessments during this period. The results from these assessments will be used to identify mitigation strategies and to focus research questions.
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."
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 with 95 actively submitting data. We are continuing to increase the number of participating laboratories and types of data being submitted into the system. 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, CDC's Laboratory Response Network (LRN), and USDA's National Animal Health Laboratory Network (NAHLN), 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). The LRN includes approximately 150 domestic and international laboratories. These laboratories are primarily responsible for testing human specimens and a subset of labs can test animal specimens. There are 39 laboratories in USDA's NAHLN that are primarily responsible for testing animal samples.
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 microbiological and chemical analyses of imported food. FDA took possession of the completed mobile laboratories in April 2005. The Microbiological Mobile Laboratory Unit was utilized in October 2005 during an emergency deployment to assist the Department of Health and Hospitals Laboratories (DHHL) in Louisiana. The DHHL laboratories were unable to provide analytical support due to the damage caused by Hurricanes Katrina and Rita. FDA and the DHHL analysts worked together in the Mobile Laboratory to provide on-site analytical testing of water samples from shellfish-growing waters.
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 (http://www.fda.gov/oc/bioterrorism/bioact.html).
FDA began focusing 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. FDA has also shared research findings with industry in order to further protect the food supply from deliberate attack.
HHS Avian Influenza Efforts
Department of Health and Human Services (HHS) Secretary Mike Leavitt has made influenza pandemic planning and preparedness a top priority. The FDA and other agencies within HHS are working together formally through the Influenza Preparedness Task Force that Secretary Leavitt has chartered to prepare the United States for this potential threat to the health of our nation. The Department is also working with other federal, state, local and international organizations to ensure close collaboration.
As you are aware, the potential for a human influenza pandemic is a current public health concern with an immense potential impact. Inter-pandemic (seasonal) influenza causes an average of 36,000 deaths each year in the United States, mostly among the elderly and nearly 200,000 hospitalizations. In contrast, scientists cannot predict the severity and impact of an influenza pandemic, whether from the H5N1 virus currently circulating in Asia and Europe, or the emergence of another influenza virus of pandemic potential. However, modeling studies suggest that, in the absence of any control measures, a "medium-level" pandemic in which 15 percent to 35 percent of the U.S. population develops influenza could result in 89,000 to 207,000 deaths, between 314,000 and 734,000 hospitalizations, 18 to 42 million outpatient visits, and another 20 to 47 million sick people. The associated economic impact in our country alone could range between $71.3 and $166.5 billion. A more severe pandemic, as happened in 1918, could have a much greater impact.
There are several important points to note about an influenza pandemic:
In the United States, USDA and the Department of the Interior coordinate most work on avian influenza viruses among birds and other animals. HHS collaborates with USDA and the Department of the Interior in critical partnerships for domestic preparedness for a possible avian influenza outbreak in the United States. HHS relies on USDA for domestic and wild bird, backyard bird, live bird market and poultry products surveillance as a way to early detect threats to human health. Early detection will allow the US Government to have the most up-to-date and reliable information that will help to save human lives.
As you are aware, the President requested additional FY 2006 appropriations in support of his National Strategy on Pandemic Influenza. In seeking this funding, the goals are: to be able to produce a course of pandemic influenza vaccine for every American within six months of an outbreak; to provide enough antiviral drugs and other medical supplies to treat 25 percent of the U.S. population; and, to ensure a domestic and international public health capacity to respond to a pandemic influenza outbreak.
Thank you for this opportunity to discuss our counterterrorism activities to protect the food supply. I would be pleased to respond to any questions.
Last Revised: January 10, 2006