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Fact Sheet

FOR IMMEDIATE RELEASE
August 15, 2006

Contact: HHS Press Office
(202) 690-6343

DRUG SAFETY IS A FOREMOST PRIORITY OF THE FOOD AND DRUG ADMINISTRATION

Overview: Security of the United States food supply is a top priority for this Administration, the Department of Health and Human Services (DHHS), and DHHS� Food and Drug Administration (FDA). After the attacks on 9/11/2001, the White House Office of Homeland Security issued the National Strategy for Homeland Security which identified FDA and USDA as lead agencies in protecting the food and agriculture supply against bioterrorism.

The FDA is well equipped for the job. It regulates animal feed and 80 percent of human food: everything we eat except for meat, poultry, and some egg products, which are under the regulatory purview of the U.S. Department of Agriculture (USDA). And the FDA has 100 years of experience in safeguarding the U.S. food supply in close cooperation with other federal agencies, state and local governments, industry, academia and the public.

To fulfill its critical counter-terrorism responsibilities, the FDA has been working closely and intensively with other food safety agencies, with law enforcement and intelligence-gathering agencies, and with industry. This effort has produced significant progress.

Today, the U.S. authorities and food industry know much more about the vulnerability of food to potential attacks by terrorists, and how that risk can be confronted. Government, industry and academia have conducted exercises to test response and recovery following an attempt to contaminate the food supply. And since 2002, the FDA has been implementing a major new law that greatly adds to the agency�s ability to prevent contaminated food from entering the U.S. market.

These and other security measures are protecting the nation�s food supply from both intentional and unintentional contamination.

FDA�S ROLE IN COUNTERTERRORISM ACTIVITIES

The FDA is central to the nation�s counter-terrorism efforts for several reasons. An attack on the food or animal feed supply could create severe public health issues, disrupt the availability of food, undermine the public�s confidence in its safety, and cause significant economic losses. The FDA has decades of experience in protecting the safety of the U.S. food supply in cooperation with others in the public and private sectors, an ability which is essential for confronting the threats of terrorism. Moreover, the security and availability of other FDA-regulated products -- human drugs, vaccines, tissues for transplantation, blood for transfusion, medical devices, and veterinary drugs -- would be essential for preventing or mitigating the public health consequences of an act of terrorism.

To do its part on the front line against terrorism, the FDA has been working closely with many partners, including USDA, the White House Homeland Security Council, the Department of State, the Centers for Disease Control and Prevention (CDC), and the Department of Homeland Security (DHS). FDA�s Office of Criminal Investigations (OCI) also maintains professional relationships with the U.S. intelligence and counter-terrorism community, as well as domestic and foreign law enforcement agencies.

Here are some of the main accomplishments in recent years:

Vulnerability and Threat Assessments

Using advanced methodologies and processes developed by the U.S. Department of Defense, the FDA has developed vulnerability assessments for several categories of foods. These assessments evaluate the relative public health consequences of potential tampering, criminal, malicious, or terrorist acts involving food, and can help guide decisions about the use of public health resources to minimize such risks. The assessments can assist also the food industry in identifying preventive measures for strengthening the security of the food supply. The results of these ongoing FDA assessments are being used to develop countermeasures, identify research needs, and provide additional guidance to the affected industry.

In addition, in July 2005 USDA, FDA, DHS and the Federal Bureau of Investigation announced a new collaboration with states and private industry to protect the nation�s food supply from terrorist threats. The Strategic Partnership Program Agroterrorism (SPPA) Initiative is a cooperative effort to assess and identify vulnerabilities in the agriculture and food sectors.

Industry Guidance on Preventive Measures

The FDA has used some of its findings about the risks of bioterrorism to publish guidances on how to protect food products against tampering and intentional contamination. The agency has issued and widely distributed these documents for food producers, processors, and transporters; food importers and filers; retail food stores and food service establishments; the milk industry; and cosmetic processors and transporters. The guidances are also handed out and discussed by FDA�s field personnel and their state counterparts during inspections and import examinations.

Another measure to safeguard the food supply is a web-based security awareness-raising training program conducted by the FDA in partnership with USDA. 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 of the food industry and other individuals -- such as law enforcement, public health, and homeland security officials -- who are essential in responding to a food emergency due to a terrorist attack also are encouraged to participate in the training program.

Emergency Preparedness and Response

FDA has an Office of Crisis Management that coordinates within FDA and other agencies the preparedness and emergency response to intentional and unintentional food or feed contamination. Over the past few years, the agency has conducted or participated in numerous exercises designed to test the agency�s ability to respond to a full range of emergencies. The FDA also has discussed food defense and rapid response and recovery procedures with industry groups and trade associations.

To enhance its ability to plan for, respond to, and manage food emergencies, FDA has implemented the Emergency Operations Network Incident Management System (EON IMS), an electronic system for collection, management, and integration of large volumes of data from federal, state and local agencies. When completed, the system will enable the agency to maintain and disseminate information on specific incidents and food emergencies, and provide an instant, web-based connection for sharing and discussing real-time emergency information with all FDA offices and affected stakeholders.

Laboratory Enhancements

An essential component of the U.S. response to deliberate food-borne contamination is the ability to rapidly test large numbers of samples of foods for biological, chemical, and radiological agents. To increase this capacity in case of an emergency, the FDA and USDA�s Food Safety Inspection Service (FSIS) have created the Food Emergency Response Network (FERN) of laboratories capable of analyzing foods for a broad array of contaminants.

As of June 2005, 119 such laboratories serving 50 states and Puerto Rico have expressed interest in participating in FERN, and the FDA and FSIS are seeking to expand the network through agreements with other federal and state laboratories.

The FDA is also increasing federal, state, and local involvement in eLEXNET, a seamless, integrated, web-based data exchange system for food testing information that enables agencies to communicate, compare, and coordinate findings of laboratory analyses. This electronic capability facilitates risk assessment and trend analysis, and provides infrastructure for an early-warning system that identifies potentially hazardous foods.

At present, eLEXNET links 113 laboratories serving 50 states and the District of Columbia, and the network is growing. In addition to domestic coverage, the governments of Canada, Mexico, and the United States have agreed to test an extension of eLEXNET for sharing food sample data among the three countries.

In addition, the FDA is collaborating with Centers for Disease Control and Prevention (CDC), USDA, DHS, Environmental Protection Agency (EPA) and other agencies to create an Integrated Consortium of Laboratory Networks (ICLN). The ICLN will facilitate early detection and effective response of acts of terrorism and other events threatening to poison not only food, but also humans, animals, plants, and the environment.

Last but not least, the FDA and the U.S. Department of the Army have developed two mobile laboratories that are ready to be used at borders, ports, or other locations to rapidly analyze imported food.

Research

The priorities of FDA�s food defense research program are based on determining the food/agent combinations of highest concern, and on the need to anticipate, prevent, detect, respond, and recover from terrorists� assaults on the food supply. This requires research in five areas:

(1) knowledge of the behavior of microbiological, chemical, radiological, and biologically-derived toxic agents in priority vulnerable foods during the stages of production, distribution, marketing, and preparation;

(2) enhanced information on the susceptibility of the population to microbiological, chemical, radiological, and biologically-derived toxic agents in priority vulnerable foods;

(3) identification and/or development of new techniques for �shielding� priority vulnerable foods through the development of new prevention and/or security technologies;

(4) development of enhanced sampling and detection methods for priority agents in vulnerable foods including field deployable and in-line sensor-based screening, analytical, and investigational (forensic) technologies; and

(5) development of effective methods for ensuring that critical food production and manufacturing infrastructure can be rapidly and effectively decontaminated in event of a terrorist attack.

In accord with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), FDA�s food defense research is particularly focused on tests and sampling methodologies to detect intentional adulteration and tests that are suitable for inspections of food at ports of entry to the U.S.

The mission-critical needs require that the research also include the validation of those methodologies under realistic conditions, and their transfer to the appropriate sectors of the food industry.

PROTECTION OF IMPORTS

A critical component of the FDA�s food defense program is to ensure the safety and security of U.S. food imports, which are approaching 10 million shipments a year and increase each year by approximately 15 percent. These foods, from virtually every part of the world, are in great demand because they make a significant contribution to the American menu, in particular by supplying U.S. consumers with seafood and out-of-season fruits and vegetables.

To counter the risks of bioterrorism, the Congress and the White House have increased FDA�s counter-terrorism resources, and the agency has increased its field force to monitor the security of food and other regulated products. These employees are based in the FDA�s field offices and in 93 U.S. ports of entry, where they have multiplied the number of imported food examinations.

The most extensive safeguards, however, have been created by the Bioterrorism Act, which gives the FDA unprecedented authorities to protect the nation�s food supply.

Here are the main provisions of the Bioterrorism Act:

Registration of Food Facilities

The Bioterrorism Act requires registration of foreign and domestic food facilities that manufacture, process, pack, or hold food for consumption by humans or animals in the U.S. Thanks to this provision, FDA has, for the first time, a roster of over 270,000 facilities -- more than 116,000 domestic and 155,000 foreign -- that provide food for American consumers. In the event of a potential or actual terrorist incident or an outbreak of foodborne illness, this information will help FDA to quickly identify facilities that may be affected.

Prior Notice of Imported Food Shipments

The law requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the U.S. The time limit for submitting the advance notice, which can be sent electronically either to the FDA or CBP, varies for different means of transportation.

This advance information enables the FDA to identify potentially risky consignments and target inspections at the border. The agency carries out this essential function in close cooperation with analysts at the CBP�s National Targeting Center and using CBP�s Automated Targeting System.

Since December 2003, the two agencies have been receiving approximately 180,000 prior notifications each week, all of which are screened electronically. In addition, FDA conducts manual, comprehensive import security reviews for identified high risk products. In FY 2005, FDA performed such reviews for 86,187 food shipments, more than double the number in FY 2004.

Administrative Detention

The Bioterrorism Act granted the FDA the authority to administratively detain any article of food or feed for which the agency has credible evidence or information that it presents a threat of serious adverse health consequences or death to humans or animals. This new authority, which is self-executing, enables the agency to detain suspected products without a court order, and therefore act more quickly to prevent harm. The shipper�s or importer�s rights are protected by an FDA rule that provides expedited procedures for appealing a detention order.

Maintenance and Inspection of Records

Under the Bioterrorism Act, FDA issued a rule requiring persons that manufacture, process, pack, transport, distribute, receive or hold food or feed in the U.S. to establish and maintain records showing the immediate previous source(s) and immediete subsequent recipient(s) of these products. The FDA is authorized to have access to these records if it has a reasonable belief that the products present a threat of serious adverse health consequences or death to humans or animals. This regulation enhances FDA�s ability to trace the origin and track and contain suspect foods or feeds before they reach American consumers.

Authority to Commission Other Federal Officials

The Bioterrorism Act also has authorized the FDA to multiply its surveillance resources by commissioning other federal officers and employees to conduct examinations and investigations of FDA-regulated products at facilities where the two agencies share jurisdiction. Under this new authority, FDA and CBP have signed a Memorandum of Understanding to commission CBP officers to carry out such activities at the U.S. ports of entry where FDA may have no or insufficient staff. FDA has already commissioned over 8,150 CBP officers who now help enforce the prior notice rule at all of the nation�s approximately 350 points where foreign goods arrive in this country.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last Revised: August 15, 2006

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