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Counterterrorism

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.

FDA Counterterrorism Website
FDA Bioterrorism Act Website

The following is an excerpt describing this initiative from FDA's FY 2004 Annual Performance Plan.

Problem
Desired Outcome
Key Strategies
FY 2004 Goal Highlights
Current Status
FY 2002 Performance Goals
FY 2001-2002 Highlights


Related Information

Problem

A combination of public health and law enforcement responsibilities defines FDA Counterterrorism activities. Regardless of the circumstances, FDA must uphold its responsibility for ensuring the safety of approximately 80 percent of the Nation's food supply, as well as ensuring the availability of safe and effective drugs, vaccines, blood products, medical devices, and animal drugs and feed. The scope of the Agency's Counterterrorism activities includes both the civilian and military sectors of the population. The Office of Crisis Management (OCM) has been created to provide an umbrella office of three programs, Office of Counterterrorism Programs, Office of Emergency Operations and Office of Physical Security, which coordinate the majority of internal and external FDA activities to meet these responsibilities.

There is little experience in this country with terrorist agents targeting the U.S. civilian population. The possibility of food products being used as a vehicle for attack is particularly worrisome because such an event potentially affects every U.S. citizen. FDA must have the capability to be vigilant in assessing, and then quickly and effectively reducing risks associated with unexpected and potentially widespread health and safety threats to the U.S. public. The unpredictability and wide variety of ways that potential acts of terrorism can be launched complicate preparedness and the ability to quickly and effectively respond to just such an attack.

The challenge for FDA is being prepared to safeguard products in light of the possibility that terrorists could strike at any point in the product pipeline -- from production through distribution and use/consumption; and in both import and domestic arenas.

Desired Outcome

Ensure that U.S. citizens are protected from public health threats posed by unexpected and potentially widespread terrorist attacks by enhancing the ability of the Nation's health care system to effectively respond to Counterterrorism and other public health challenges. A key outcome of this effort is that all Americans continue to enjoy a safe and secure food supply.

Key Strategies

FDA has developed an integrated strategic approach to address the Counterterrorism threat in the U.S. and protect the citizens of our homeland. These strategies are complementary to DHHS' Strategic Goal "To Protect Our Homeland" and have the following characteristics. They:

• Build upon existing Agency capacities to manage health and safety risks.
• Leverage the strengths of health, scientific, and law enforcement agencies to create a powerful and effective response to terrorism.
• Magnify the benefits of various streams of knowledge by bringing the right combination of information to crucial decision points.

The total effect is the creation of a safety net that significantly reduces the probability that terrorists will ever achieve their aims; and minimizes the impact of these threats if they do occur.

This safety net consists of four strategies:

• Protect regulated products: Deter, detect, investigate and interdict terrorist threats before they become a reality. Because FDA is responsible for such a large segment of the nation's food supply, food safety is a significant component of this strategy.
• Develop medical countermeasures to minimize the impact of attacks on the population.
• Sharpen the Agency's emergency preparedness and response capability so that FDA is poised to protect the Nation and itself in the event of an attack.
• Ensure that radiation devices used to diagnose or treat terrorist-related incidents are safe and effective.

Each of these strategies is described in detail below.

Protect Regulated Products: Deterrence, Detection, Investigation, and Interdiction - This strategy focuses on decreasing the threat of contamination of the food supply, drug tampering or counterfeiting, sabotage of critical medical products, and contamination of animal feed. To be successful, FDA must monitor these products from their source of production through the entire distribution system to the point of use/ consumption. This strategy encompasses all FDA-regulated products; and because threats to the food supply are such a major concern, the Agency is placing a high priority on this area. Three primary objectives are to:

1. Ensure Import Security - FDA's efforts will focus on minimizing the threat of imported foods and medical products at different stages of their life cycle:
   • At the country of origin before products are exported to the U.S.;
   • At the border to minimize the chance that hazardous products ever enter the U.S.; and,
   • Throughout the pathway that imports take in domestic commerce. Ensuring the safety of imports will require greatly enhanced information systems; laboratory analysis capability; and, a continued strong presence at the border.
2. Ensure Domestic Product Security - FDA will strengthen inspection coverage of domestic product manufacturers and product distribution; and augment product and pathogen testing.
3. Information Integration - Integrate information that is necessary to target suspected products, processes and actors to support risk management decisions; and closely monitoring product use/ consumption to detect any pattern of adverse events that may stem from terrorist-related incidents. With the passage of the Public Health Security & Bioterrorism Preparedness and Response Act of 2002, and with the requested budget increase, FDA is well on its way to establishing a National Food Registration System. This system will allow the Agency the ability to comprehensively monitor the domestic and imported food industry. With this information, FDA can more quickly and accurately follow through on high risk situations.

Medical Countermeasures - The purpose of this strategy is to ensure safe and effective drugs, vaccines, blood, medical devices and other medical products are available to prevent, diagnose or treat illnesses or injuries resulting from a terrorist attack or battlefield injury. Key objectives are to:

1. Facilitate medical product development - stewarding the development of safe and effective drugs, vaccines and medical devices that can be promptly available to protect the public health and safety in the event of an attack.
2. Facilitate the availability of necessary medical products - working with industry, Federal agencies, and foreign governments to ensure the safety and effectiveness of stockpiled medical products so that they are available in sufficient quantities to address public health emergencies.
3. Maintain the balance of public health needs and legal mandates to ensure safety -- both interests must be satisfied in monitoring and controlling medical product use at the various stages of the medical product life cycle.
4. Maintain the scientific infrastructure to ensure the availability of approved medical products.
5. Ensure the availability of specialized equipment and facilities for containment.
6. Establish and disseminate the necessary guidance/ standards.

Emergency Preparedness and Response - Pivotal among FDA's strategies is to adequately prepare for, and promptly and effectively respond to Counterterrorism threats. Key objectives are to:

1. Enhance the Agency's emergency preparedness plan to establish protocols for responding to Counterterrorism threats.
2. Establish emergency operations and laboratory networks that integrate critical information, procedures, key personnel and decisions in order to minimize impacts of Counterterrorism threats.
3. Enhance emergency preparedness and response.
4. Ensure the safety and security of FDA's most important assets -- FDA personnel, physical assets, and information.
5. Establish a plan for continuity of FDA operations in an emergency.

Radiation Safety - FDA's fourth strategy focuses on radiation-emitting devices that are used to:

• Detect potential security threats - e.g. in airports,
• Destroy pathogens that may be released during a terrorist incident.
• Treat victims of terrorist-generated radiation incidents.

This strategy also addresses the efficacy of devices that are used to detect the presence of radiation associated with terrorist events. Within this strategy key objectives are to:

1. Ensure that radiation-emitting products used for security screening or irradiation are safe both for human operators and human subjects.
2. Facilitate development and efficient distribution of medical countermeasures to address radiation incidents.
3. Develop a radiological health emergency preparedness program.

Performance Goal Highlights for FY 2004

Premarket

FDA is committed to bring the Agency to a state of readiness in addressing the Counterterrorism threat to this Nation. The strategies begun in FY 2002 and FY 2003 were steps toward a long-term solution. In FY 2004, goals have been developed to further strengthen the Agency's capability to respond to a Counterterrorism emergency. Examples of FY 2004 goals include:

• Expand Federal/State/local involvement in FDA's eLEXNET system by having 79 laboratories participate in the system.
• Inspect 95 percent of high-risk domestic food establishments once every year.
• Perform 48,000 physical exams and conduct sample analyses on imported products with suspect histories.
• Perform at least 1,000 Filer Evaluations under new procedures.
• Conduct 2,000 examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA are being exported.
• Enhance states' laboratory analysis (8 new participating laboratories); and inspection capabilities (1,200 more inspections)

Current Status

The President's FY 2003 budget for bioterrorism significantly strengthened FDA's ability to counter the terrorist threat at the border through personnel enhancements. However, FDA still has limited capacity to monitor or control the flow of imported foods, inspect domestic manufacturers, and detect foodborne pathogens before they cause human illness. When these limitations are combined with the possibility of a deliberate attempt to contaminate the food supply at any point along the food production, processing and distribution chain, the risk associated with a potential Counterterrorism incident are greatly increased.

In FY 2004, FDA will strengthen the import information systems to improve targeting of suspect products, and to enhance links between import and domestic information systems, so that imported products can be traced in domestic commerce. FDA believes that by coordinating a laboratory response network, it will enhance the Agency's ability to identify and contain outbreaks associated with deliberate attempts to contaminate the food supply.

The Agency is continuing to make strides in each of the major Counterterrorism goal areas:

Protect Regulated Products: Deterrence, Detection, Investigation, and Interdiction - FDA has assigned a cadre of field investigators at the border that will increase by 100 percent the number of import physical exams conducted during FY 2003. Targeted inspections of food entries and high-risk domestic food inspections continue to be the focus of effort in this area of protecting regulated products.

Additionally, in FY 2004, FDA will bolster its existing Foods Domestic Retail and Interstate Travel Programs (ITP). The Foods Retail works cooperatively with state and local governments to ensure that their resources expended for this program are directed towards activities producing the greatest degree of consumer protection. The ITP inspects passenger conveyances (planes, busses, trains, water vessels) and support facilities (watering points, food caterers, and waste facilities) involved in interstate commerce to ensure safe drinking water and food.

During FY 2003, FDA will develop a more robust imported products physical examination approach that merges the assessment of information integrity with the safety and security of the product. The Agency will also develop better estimates of time required for the new augmented examination so that appropriate resources can be matched with the revised approach.

Passage of bioterrorism legislation in FY 2002 provided FDA with greater regulatory authority to detain and refuse entry to suspect products; to require that accurate records be maintained by shippers and importers of food products; and, to require that all establishments register with FDA in order to ascertain those firms that are shipping products to the U.S.

Medical Countermeasures - In the Federal Government's response to various agents of mass destruction, drugs will be mobilized from the CDC's National Pharmaceutical Stockpile (NPS). However, not all drugs in the NPS are FDA-approved for medical countermeasures. The ultimate goal is that regulated products in the NPS will be approved as safe and effective and will be appropriately labeled to treat the medical consequences of biological, chemical or radiation attacks. In addition, FDA is preparing guidance for industry on the development of products that can be used as medical countermeasures. The guidance will provide information regarding the development of antiviral drugs and post exposure anti-microbial drugs for inhalational anthrax. Further, the Agency is expediting the review of protocols and facilitating the conduct of human clinical trials for new investigational radioprotectant drugs, and drugs to treat organophosphorous nerve agents.

The Food and Drug Administration is requesting grant applications to support clinical trials on the safety and effectiveness of drug products for the treatment of human plague (bubonic, pneumonic, meningitic, or septicemic) caused by Yersinia pestis. FDA anticipates awarding up to three awards each for a total of up to $700,000 for two years. These grants are available to any foreign or domestic, public or private nonprofit entity (including State and local units of government) and any foreign or domestic, for-profit entity that waives its fees. This program is part of FDA's Counterterrorism efforts.

On January 31, 2002, FDA took the final actions necessary to allow the BioPort Corporation to begin routine distribution of licensed anthrax vaccine from its renovated facility. Due to the complex nature of biological products, the Public Health Service Act and FDA regulations require approval of a supplement for major changes made to a facility in which a licensed product is manufactured. In addition, each lot of anthrax vaccine undergoes thorough testing for purity, potency, identity and sterility. No lot of anthrax vaccine can be distributed from the renovated facility until FDA's Center for Biologics Evaluation and Research releases it based on the results of these tests. This process, called lot release, helps assure product safety by providing yet another quality control check on product specification.

A radioprotectants team was created to increase the availability of products to prevent and treat radiotoxicity. The following drugs are currently under development as heavy metal chelators: Prussian Blue, Calcium DTPA, and Zinc DTPA. In addition, FDA's Division of Radiopharmacolgical Drug Products has worked extensively with the sponsors of these drugs in providing advice and assistance. It has also conducted numerous literature searches, reviewed published information, and worked with external groups to gather additional information on these products.

Emergency Preparedness and Response - FDA has developed a Continuity of Operations Plan (COOP) which will allow the Agency to keep its major programs functioning in the event of a disabling attack.

To facilitate the sharing of laboratory results, particularly during a terrorist incident, the Electronic Laboratory Exchange Network (eLEXNET), a federally coordinated effort, will be expanded to include more State health laboratories in both FY 2003 and FY 2004. This system is the first Internet? based food safety system that consolidates and shares pathogenic findings among Federal, State, and local government laboratories.

FY 2002 Performance Goals

Highlights of FY 2001-2002 Accomplishments

Protect Regulated Products: Deterrence, Detection, Investigation, and Interdiction -

• Hired and began training 655 new investigators, analysts and other support personnel as authorized by the FY 2002 Counterterrorism Supplemental Appropriation. These personnel improve the Agency's capacity to respond to Counterterrorism threats and attacks and augment domestic food safety and security. Many are investigators and analysts who closely monitored the highest risk imports entering the country, and allowed FDA to increase border presence by doing more field exams, sample collection and analysis, domestic inspections and laboratory analysis. FDA increased physical exams by 100 percent in FY 2002, and projecting to do so again in FY 2003.
• Conducted intense threat assessments of risks of different products and agents that could be used for a Counterterrorism attack involving intentional contamination during various stages of food production and distribution.
• Developed rapid methods for detecting microbial and viral food contaminants. FDA has leveraged this expertise with public and private sector partners to operate national rapid identification systems used to control outbreaks of foodborne diseases.
• Published guidance for domestic food producers and importers on preventive measures to increase their preparedness and enhance the security of their products (67 FR 1224; January 2, 2002).
• Took steps to increase assurances that products imported into this Country will be safe. Published a proposed rule that would have required marking, prior to exportation, of all foods refused for safety reasons, and would have assured that marked products were exported and not re-entered into the U.S. marketplace. This rule has been withdrawn, as the proposed marking provisions of the rule were incorporated into the recent bioterrorism legislation.
• Contributed to the development of methodology for the detection of biological agents with Counterterrorism threat potential.
• Upgraded designated laboratory facilities to a BioSafety Level 3 (BSL-3) to support microbial Counterterrorism research. BSL-3 facilities have containment capability that allows work with indigenous or exotic agents that may cause serious or potentially lethal disease.
• Obtained High Performance Liquid Chromatography equipment needed for rapid analysis of suspect foods to assay for biological or chemical agents that could be introduced into food products.
• Outfitted upgraded laboratory facilities with infrastructure to include containment hoods and appropriate filtering and monitoring devices. This will allow researchers to characterize multiple strains, construct a library/ database of constituent proteins and query the library/ database to find toxin related markers.

Medical Countermeasures - The Office of Crisis Management is the "portal of entry" to FDA for any inquiries regarding existing regulatory mechanisms for enhanced product availability, and Counterterrorism initiatives and programs across the Agency. The Office coordinated a number of efforts to serve emergency public health needs. These included the following:

• Coordination to provide expedited regulatory guidance to CDC during the administration of post exposure anthrax vaccine and antibiotics to Capitol Hill and Postal Service employees.
• Coordination to respond to an inquiry from U.S. Special Forces regarding the availability of medical countermeasures to assist in the deployment of airborne hospital facilities for the evacuation of battlefield casualties.
• Response to inquiry from Joint Chiefs of Staff regarding availability of critical medical product for combat readiness.
• Response to hundreds of inquiries from product developers-small and large companies, academic investigators, other federal agencies, concerned citizens- regarding access to FDA, questions of regulatory jurisdiction, liaison with product centers to develop Counterterrorism-related medical products.
• Launched an internship program with DoD to facilitate understanding of the regulatory needs of military programs conducting research, developing medical countermeasures, planning combat readiness, and caring for military personnel. The first intern reported in July 2002 for a 12-month tour.
• Engaged in the development of new regulatory models to support preparedness in the case of an emergency attack - e.g., anthrax. FDA also participated in the U.S. Office of Foreign Disaster Assistance tabletop exercise with other Federal, State and local governments to prepare for the eventuality of a terrorist attack.
• Launched the Counterterrorism Tracking System (CTTS), an electronic database used throughout the Agency for real-time status reports on counterterrorism activities. The system was developed with the Office of Information Resources Management. The Office of Crisis Management maintains and monitors the system and trains system users.

FDA took the initiative to clarify that the antibiotics, doxycycline and penicillin G procaine, are effective and approved for use in treating all forms of anthrax infections. This notice included explicit dosing based on FDA's review of scientific literature and data from the same rhesus monkey study that had been used to support the August 2000 approval of ciprofloxacin for the treatment of anthrax. The assurance that the three drugs are effective against all forms of anthrax infection eased the public's concerns about a potential shortage of medication for the victims of the mailed anthrax powder.

Worked closely with industry and other government agencies to assure adequate supply of products for immunization against anthrax, botulism, smallpox and other substances that might be used by terrorists, and to evaluate adverse experiences reported after administration of anthrax vaccine to optimize the safe use of this vaccine.

On May 31, 2002, the Agency published a rule which allows approval of new drug and biological products for the treatment of chemical, biological, radiological, or nuclear substances based on animal efficacy studies when adequate and well-controlled studies in humans cannot be ethically conducted and field studies are not feasible.

FDA collaborated with the National Institutes of Health in developing a guidance on the use of potassium iodide to reduce the risk of thyroid cancer in radiation emergencies.

Emergency Preparedness and Response - Strategic Plan/Action Plan: The attacks of September 11, 2001, the subsequent anthrax outbreak, U.S. military deployment in Central Asia, and the need to respond to a possible anthrax contamination of our own facilities broadened and intensified the Agency's Counterterrorism activities. A comprehensive update of the existing FDA Counterterrorism Strategic Plan was completed early in 2002 to meet the Agency's need to coordinate this greatly expanded area. This was followed by the drafting of the Agency Action Plan to identify specific activities needed to meet the goals of the Strategic Plan.

• Worked hand-in-hand with CDC's Public Health Information Network, and in very close coordination and cooperation with CDC. FDA will continue to work to make the Electronic Laboratory Exchange Network (eLEXNET) an integral component of the Public Health Information Network.
• Expanded existing service contracts for obtaining additional guards for a number of FDA facilities.
• Secured storage for select agents to prevent unauthorized use or theft.
• Opened the FDA Emergency Operations Center in FDA Headquarters Building in Rockville, Maryland.
• Managed, tracked and investigated over 150 significant incidents and emergencies involving FDA regulated products.
• Managed the National Consumer Complaint System that collects information on the condition of FDA regulated products on the market with which consumers are dissatisfied for reasons such as violation of the law, or for causing injury or death. This information can be compiled and evaluated to highlight current problems and long term trends, and can be used as background data in the development of FDA programs. Processed 6066 complaints in FY 2002.
• Planned, developed and conducted emergency response exercises for FDA personnel, to prepare for potential BSE and Bioterrorism emergencies.
• Provided planning, coordination and support for the HHS Command Center during the Winter Olympics.
• Drafted and issued the FDA Radiological Emergency Response Plan.
• Drafted and issued the FDA Chemical and Biological Emergency Response Plan.
• Awarded the contract to design and develop the FDA Emergency Operations Network (3 to 4 year project) to create functional and technological infrastructure for a seamless emergency preparedness and response system.

Related Information:

Ensuring the Safety and Security of the Nation's Food Supply