Food and Agricultural Biosecurity: Planning and Preparedness

Federal Legislation and Presidential Directives
Key Activities of Federal Agencies
Guidelines
Food Emergency Response Network
Information Sharing and Analysis
References

Efforts to prevent and respond to potential deliberate contamination or disruption in the food system encompass a broad range of public and private sector activities. Some of these efforts grew out of traditional food safety responsibilities, while others were developed in response to the potential threats of large-scale, coordinated attacks. The latter includes improvements in security, threat assessment, disease surveillance, laboratory detection, communications, and coordination among federal, state, and local agencies responding to emergencies involving the production and distribution of food nationwide.

This document summarizes current public sector activities, beginning with national policy initiatives, directed at planning and preparedness for potential threats and contamination events. Major federal responsibilities for food system biosecurity are also listed in the tables below, followed by brief descriptions of collaborative efforts in two additional areas—laboratory detection of food contaminants and information sharing and analysis regarding threats and responses.

 

Federal Legislation and Presidential Directives

Prior to 9/11, food and agriculture did not figure prominently in federal critical infrastructure protection (CIP) initiatives, including the landmark 1998 Presidential Decision Directive 63 (see References: PDD-63). Executive Order 13228 establishing the Office of Homeland Security, issued in October 2001, first cited food and agriculture in the list of critical infrastructure sectors requiring protection from the consequences of terrorist attack. Several other initiatives followed: the 2002 Homeland Security Act directed federal agencies to take steps to assure the safety of food and agriculture, and the comprehensive National Strategy for Homeland Security, issued in July 2002, identified lead federal agencies, including the Department of Homeland Security (DHS), responsible for working with the food and agriculture sectors to develop CIP plans (see References: GAO 2003).

DHS' follow-up document, the National Strategy for the Physical Protection of Critical Infrastructures and Key Assets, noted recent efforts by the Department of Agriculture (USDA), the Department of Health and Human Services (DHHS), and other federal agencies to protect the food system, such as:

• Conducting risk assessments and evaluating food system vulnerabilities
• Enhancing detection and testing capabilities
• Assessing security risks in food and commodity transportation
• Exploring ways to encourage prompt reporting of problems
• Developing strategies to coordinate risk communication and other emergency response activities

Several recent high-profile initiatives, described below, further define the government's role in directing and coordinating efforts to respond to the threat of food and agricultural terrorism.

Defense of United States Agriculture and Food—Homeland Security Presidential Directive 9 (HSPD-9)

Homeland Security Presidential Directive 9 (see References: HSPD-9) issued January 30, 2004, represents a major step toward establishing a comprehensive national policy to protect the agriculture and food system against "terrorist attacks, major disasters and other emergencies." Its primary areas of focus are:

• Identifying and prioritizing critical infrastructure and key resources in the food system
• Enhancing threat-assessment capabilities
• Reducing vulnerabilities in critical points during food production and processing
• Improving screening and inspection procedures for domestic and imported food products
• Enhancing emergency response and recovery procedures

HSPD-9 establishes DHS' role as policy coordinator and reiterates the jurisdictions and statutory responsibilities of USDA, DHHS, and the Environmental Protection Agency (EPA) as defined in an earlier presidential directive, HSPD-7 (see below). HSPD-9 highlights the following activities and programs:

• Surveillance and monitoring systems that facilitate early detection of intentional contamination of food or spread of disease among crops or livestock
• Mechanisms to identify and trace back specific animals, plants, commodities, and food products to sites of production
• Nationwide coordinated laboratory networks for food, veterinary, plant health, and water quality 
• Enhanced capabilities for early detection, characterization, and assessment of biological agents in the food system, as the focus of a new federal organization (location and structure to be determined)
• Vulnerability assessments of the food system, updated on a regular basis
• Mitigation strategies to prevent the intentional contamination of food during production and processing or the introduction of plant or animal diseases
• Inspection of domestic or imported foods
• Coordination of response plans and recovery systems for agriculture and food-related emergencies
• Provision of adequate animal vaccines and other medicines to respond, within 24 hours, to potentially devastating animal disease outbreaks, through a National Veterinary Stockpile
• Coordination of effective responses to disease outbreaks in economically important crops through the National Plant Disease Recovery System 

HSPD-9 also calls for DHS, DHHS, and USDA to collaborate with private sector entities to establish "an effective information sharing and analysis mechanism" for the agriculture and food sector; no specific requirements or timetable is stated in the directive. DHS' Information Analysis and Infrastructure Protection (IAIP) Directorate is currently facilitating this collaborative effort between government and industry representatives (see below).

Educational initiatives outlined in HSPD-9 focus on capacity-building grants to universities for programs aimed at training professionals in homeland security and food protection. These programs include:

• Professional development
• Specialized training in animal, plant, and public health
• Iinterdisciplinary graduate programs in food science agriculture, medicine, veterinary medicine, epidemiology, microbiology, chemistry, engineering, and statistical modeling  
• HSPD-9 also calls for the establishment of university-based centers of excellence in agriculture and food security. At the time the directive was released, DHS' Office of University Programs, Science and Technology Directorate, had recently issued a Broad Agency Announcement for two such centers [see References: DHS 2003]. In April 2004, DHS announced the awardees—the National Center for Foreign Animal and Zoonotic Disease Defense, based at Texas A&M University, and the National Center for Food Protection and Defense, based at the University of Minnesota [see References: DHS 2004].

Critical Infrastructure Identification, Prioritization, and Protection—Homeland Security Presidential Directive 7 (HSPD-7)

Homeland Security Presidential Directive 7 (see References: HSPD-7) issued December 17, 2003, focuses on issues concerning protection of all national critical infrastructures and key resources, the majority of which are owned and operated by the private sector and state or local governments. HSPD-7 supersedes previous presidential directives, including PDD-63, which provided an initial framework for federal infrastructure-protection activities. HSPD-7 expands the federal role in infrastructure protection, with the DHS as the lead federal agency. It outlines roles and responsibilities in the following areas:

• The secretary of DHS: designated the lead federal official responsible for integrating and coordinating infrastructure protection and risk management activities within and across sectors
• Federal agencies with responsibility for infrastructure protection in certain areas ("sector-specific agencies"), such as the departments of agriculture, health and human services, energy, and transportation: directed to collaborate with federal departments and agencies, state and local governments, and the private sector in activities related to the protection of critical infrastructure and key resources. This the first time that USDA is officially recognized as a sector-specific federal agency for the protection of agriculture and food, including meat, poultry and egg products, as critical infrastructures; similarly, the Department of Health and Human Services, which was previously recognized for the protection of health care services, is recognized in HSPD-7 as a sector-specific agency for the protection of food, excluding meat, poultry, and egg products (corresponding to DHHS' and USDA's food safety jurisdictions). 
• Other federal departments, agencies, and offices with special functions in critical infrastructure protection, such as the departments of state, justice, and commerce, offices, and councils: special functions designated according to their previously defined food safety roles.

HSPD-7 directs DHS and the sector-specific federal agencies (including USDA, DHHS, and EPA) to work with the private sector and encourage private sector entities to develop information sharing and analysis mechanisms to facilitate sharing of information about "physical and cyber threats, vulnerabilities, incidents, potential protective measures, and best practices." It also sets a target date of December 2004 for DHS' completion of a national Plan for Critical Infrastructure and Key Resources Protection that delineates the following:

• A federal strategy for identifying, prioritizing, and coordinating activities related to critical infrastructure and key resource protection
• Specific activities needed to support the overall strategy
• Initiatives underway to share information, particularly related to threats and warnings, with state and local governments and the private sector
• Coordination and integration of critical infrastructure protection activities with other federal emergency management and preparedness efforts

The Public Health Security and Bioterrorism Preparedness and Response Act (Public Law 107-188)

The Public Health Security and Bioterrorism Preparedness and Response Act (also known as the "Bioterrorism Act of 2002"), signed into law on June 12, 2002, authorizes over $4 billion for a wide range of bioterrorism preparedness initiatives. These include improvements in preparedness for bioterrorism and other public health emergencies, enhancement of controls on dangerous biological agents and toxins, and protection of food, drugs, and public drinking water from deliberate contamination (see References: Bioterrorism Act of 2002).

Issues relating to the safety and security of the food supply are addressed in Title III, "Protecting the safety and security of the food and drug supply." Food and agriculture provisions are grouped as follows:

• Title III, Subtitle A, "Protection of the Food Supply," which includes provisions that amend the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) and therefore require FDA to issue new regulations in four key areas (see FDA: The Bioterrorism Act of 2002; Plans for developing bioterrorism related food regulations; FDA actions on new bioterrorism legislation)
• Title III, Subtitle C, "General Provisions Relating to Upgrade of Agricultural Security," pertaining to USDA's responsibilities

Subtitle A includes the following provisions under FDA's authority:

• Protection against adulteration of food (Section 302):
• Increased inspections of imported food
• Improvements in FDA's information management systems
• Improved linkages between FDA and other federal food safety regulatory agencies
• Providing for research to develop tests and sampling methodologies for rapid detection of adulteration of food
• Conducting threat assessments of intentional adulteration and reporting of findings to Congress (see FDA 2003 report to Congress)
• Administrative detention (Section 303)—expands FDA's authority to order the temporary detention in a secured facility of any food for which there is credible evidence or information that the food poses a threat of "serious adverse health consequences or death to humans or animals." FDA's final rule, effective July 6, 2004, authorizes the use of administrative detention and provides procedures for instituting "on an expedited basis certain enforcement actions against perishable food subject to a detention order" (see References: FDA: final rule; fact sheet).
• Registration of food facilities (Section 305)—requires any domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States to register (through electronic means) verifiable contact information and food product categories with FDA by December 12, 2003, and requires FDA to compile and maintain a current, validated list of registered facilities. FDA issued its interim final regulation in October 2003 (see References: FDA: interim final regulation; fact sheet; electronic registration via the Internet)
• Establishment and maintenance of records (Section 306)—authorizes FDA to have access, under certain circumstances, to industry records, such as shipment data, concerning the manufacture, processing, packaging, distribution, receipt, holding, or importation of food (but not other information, such as personnel data, finances, recipes, or research data). This rule applies to facilities that manufacture, process, pack, transport, distribute, receive, hold, or import food, including foreign companies that ship food to the United States; farms and restaurants are exempt. This provision is designed to facilitate identification of immediate previous sources and immediate subsequent recipients of food in the supply chain ("one up" and "one down"), in order to track potentially contaminated products during emergencies. FDA issued proposed regulations in May 2003, requiring the establishment of these requirements by December 12, 2003 (see References: FDA: fact sheet).
• Prior notice of imported food shipments (Section 307)—requires that FDA receive advance notice of food imported into the United States, beginning on December 12, 2003; without such notice, such shipments can be refused admission or held at the port of entry. Importers are required to provide at least two, four or eight hours' notice, depending on the mode of transportation, before each shipment's arrival at the U.S. border. Notices can be files electronically either through the Bureau of Customs and Border Protection or the Prior Notice System Interface (see References: FDA: Prior notice of imported foods; press release). This rule is intended to enable FDA to target inspections more effectively. FDA issued its interim final rule in October 2003 (see References: FDA: fact sheet), which becomes effective December 12, 2003.

Subtitle C includes the following provisions under USDA's authority:

• Expansion of Animal and Plant Health Inspection Service (APHIS) activities (Section 331)—improve APHIS' capacity to prevent and respond to deliberately introduced plant and animal diseases through expanded services for inspection of imported products, surveillance mechanisms, tracking of animal and plant shipments, and planning and coordination with state and local agencies.
• Expansion of Food Safety Inspection Service (FSIS) activities (Section 332)—improve FSIS' capacity to inspect international meat, poultry, and egg products where they are produced and at ports of entry.
• Biosecurity upgrades at USDA facilities (Section 333)—update and renovate existing laboratory and research facilities in New York (Plum Island Animal Disease Center), Iowa (ARS/APHIS facility), and Wyoming (Arthropod-Borne Animal Disease Laboratory), and develop a new bio-containment laboratory for poultry research in Athens, Georgia.
• Agricultural biosecurity (Section 334)—review security standards and practices at land-grant colleges and universities with programs in food and agricultural sciences; award grants to food industry associations to develop and implement educational programs to enhance biosecurity on farms.
• Agricultural bioterrorism research and development (Section 335)—enhance capabilities to respond to emerging or existing threats to the food system; develop university-based planning, training, outreach, and research programs related to "vulnerability analyses, incident response, detection, and prevention technologies;" coordinate activities with the intelligence community to enhance threat assessment capabilities; develop rapid detection field test kits and provide such kits to state and local agencies; and develop an early warning surveillance system linking state veterinary diagnostic laboratories, federal and state agricultural research facilities, and public health agencies.

The Farm Security and Rural Investment Act of 2002 (The Farm Bill) (Public Law 107-17)

Among its many provisions covering a wide range of agricultural issues, the Farm Bill establishes biosecurity planning and response programs (See Farm Bill, Title VII, Section 7221). The law authorizes funding for agricultural research, education, and extension activities to:

• Reduce the vulnerability of the U.S. food system to chemical or biological attack
• Continue partnerships with institutions of higher education and other institutions to coordinate the development, implementation, and enhancement of diverse capabilities for addressing threats to the nation's agricultural economy and food supply, with special emphasis on planning, training, outreach, and research activities related to vulnerability analyses, incident response, and detection and prevention technologies
• Increase funding for ARS, APHIS, and other agencies to improve capacity to conduct research and analysis regarding bioterrorism and animal and plant diseases
• Counter and respond to chemical or biological attacks of the food system
• Provide grants for security upgrades at colleges and universities with agriculture programs

Key activities of selected federal agencies

Food system biosecurity: Key activities of selected federal agencies
Agency	Key Activities	Links
US Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS)	Based on its regulatory authority over the safety, wholesomeness, and accurate labeling of meat, poultry, and egg products, FSIS has biosecurity responsibilities that include: —Inspecting slaughter and processing plants and import facilities nationwide —Organizing federal efforts in response to food-related emergencies —Educating the public about foodborne illness —Coordinating with other federal agencies to enhance biosecurity preparedness and response —Documenting and tracking consumer complaints, including those regarding suspected contamination of meat, poultry, and egg products	Biosecurity & the Food Supply (fact sheet) Protecting America's Meat, Poultry and Egg Products: a report to the Secretary on the food security accomplishments of FSIS, 2003 (April 2004) Consumer Complaint Monitoring System (PowerPoint) FSIS (Web page)
USDA: FSIS: Office of Food Security and Emergency Preparedness (FSIS-OFSEP)	OFSEP is the lead coordinator and primary point of contact for all food security activities within FSIS and between FSIS and other federal offices (e.g., the White House Homeland Security Council and DHS). Its activities include: —Ccoordinating federal, state, and industry efforts to prevent and respond to food-related emergencies —Providing scientific expertise in biological, chemical, and radiologic terrorism —Organizing public education and awareness efforts —Coordinating emergency preparedness and response, including contingency plans to minimize risks to the food supply and to first responders FSIS-OFSEP was launched in August 2002, replacing FSIS' Food Biosecurity Action Team (F-BAT) which was set up after 9/11.	Food Security and Emergency Preparedness (Web page)
FSIS, CFSAN, CDC, APHIS, DoD, EPA, and others: Food Threat Preparedness Network (PrepNet)	Led jointly by FSIS and CFSAN, PrepNet coordinates food security and counter-terrorism efforts across federal, state, and local agencies. Its efforts focus on prevention and deterrence of food contamination incidents; emergency response; and laboratory capabilities.	CFSAN's Program Priorities: From Food Safety to Food Security (2003) Biosecurity & the Food Supply (FSIS fact sheet)
USDA: Homeland Security Council	Chaired by USDA Deputy Secretary James Moseley, the Council is responsible for establishing and coordinating overall USDA Homeland Security policy. One of its three sub-councils has responsibility for overseeing protection of the food supply and agriculture production, including: —Security issues related to food production, processing, storage, and distribution —Threats against the agriculture sector and rapid response to such threats —Border surveillance and protection to prevent introduction of plant and animal pests and diseases and —Food safety activities concerning meat, poultry, and egg inspection, laboratory support, research, education and outbreaks of foodborne illness	USDA Homeland Security Efforts (fact sheet, June 2003) Biosecurity and the Food Supply (fact sheet)
USDA and the Department of Homeland Security (DHS): Animal and Plant Health Inspection Service (APHIS)	Through monitoring activities at transportation hubs and border stations, APHIS inspects imported agricultural products for foreign animal diseases (FAD), non-native animal and plant pests, and plant pathogens. In 2003, APHIS' Agriculture Quarantine and Inspection (AQI) force was incorporated into DHS, Border and Transportation Security Directorate.	APHIS Safeguarding The Animal and Plant Health Inspection Service and the Department of Homeland Security: Working Together to Protect Agriculture USDA Amends Regulations Regarding Possession and Use of Select Biological Agents
USDA: Cooperative State Research, Education, and Extension Service (CSREES)	CSREES funds research and education programs through land-grant universities on food safety and biosecurity, including food safety risk assessment and security plans at the food-processing level.	Food Safety and Biosecurity: Food Biosecurity
DHS: Plum Island Animal Disease Center	Formerly part of USDA, the Plum Island facility conducts basic and applied research and diagnostic activities on foreign animal disease (FAD) agents, including the development of programs to prevent, respond to, and recover from the intentional introduction of highly infectious FADs into US livestock.	USDA Mission at Plum Island DHS Fact Sheet: Plum Island Animal Disease Center Transition
US Department of Health and Human Services (DHHS): Food and Drug Administration (FDA): Center for Food Safety and Applied Nutrition (CFSAN)	As the primary scientific regulatory agency for foods and drugs, FDA/CFSAN is responsible for the safety and security of the production, processing, packaging, storage, and holding of all domestic and imported foods and beverages sold in interstate commerce, including shell eggs, bottled water, and wine beverages with less than 7% alcohol. Its authority excludes: meat, poultry, and frozen, dried and liquid eggs (USDA jurisdiction); labeling of alcoholic beverages with more than 7% alcohol (jurisdiction of the treasury department's Bureau of Alcohol, Tobacco, and Firearms); and community drinking water and tolerance levels of pesticide residues in foods (EPA jurisdiction). As outlined in its 2003 strategic action plan, FDA's food biosecurity activities focus on: —Assessing food system vulnerabilities —Establishing methods to protect food that has been identified as at-risk —Implementing provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 —Supporting research and development of rapid and confirmatory laboratory methods for testing food products for select agents or toxins —Expanding the electronic laboratory exchange network (eLEXNET), a secure, Web-based data communication and alert system used to coordinate findings among laboratories in the Food Emergency Response Network (FERN).	CFSAN (Web page) Food Safety and Terrorism (Web page) Ensuring the Safety and Security of the Nation's Food Supply (2003) Counter-terrorism food emergency response network (FERN) (2003) Risk assessment for food terrorism and other food safety concerns (2003) Testing for Rapid Detection of Adulteration of Food (2003) FDA's Counterterrorism Role
DHHS: FDA: Center for Veterinary Medicine (CVM)	CVM regulates the manufacture and distribution of food additives and drugs used in food animal production. Activities in food biosecurity include: —Monitoring the safety of animal feeds —Developing analytical methods to detect chemical and biological contaminants in the animal feed supply —Working with industry representatives to develop biosecurity awareness guidelines for the feed industry —Monitoring drug and chemical residues in meat and poultry, in conjunction with USDA/FSIS —Developing methods for monitoring the safety and quality of imported foods, in conjunction with FDA/CFSAN	CVM and Counterterrorism
DHHS: Centers for Disease Control and Prevention (CDC): National Center for Infectious Diseases: Division of Bacterial and Mycotic Diseases: Foodborne and Diarrheal Diseases Branch (FDDB)	FDDB focuses on the prevention and control of bacterial foodborne and diarrheal illness, particularly investigating outbreaks and establishing short-term control measures and long-term improvements to prevent future outbreaks. Two of its major programs include: —The foodborne diseases active surveillance network (FoodNet), which provides a mechanism for responding to new and emerging foodborne diseases of national importance, monitoring the burden of foodborne diseases, and identifying the sources of specific foodborne diseases —The national molecular subtyping network for foodborne disease surveillance (PulseNet), consisting of public health laboratories that can identify specific strains of foodborne bacteria through DNA "fingerprinting" (pulsed-field gel electrophoresis).	Foodborne and Diarrheal Diseases Branch Foodborne Outbreak Response and Surveillance Unit FoodNet: Foodborne Diseases Active Surveillance Network PulseNet: the National Molecular Subtyping Network for Foodborne Disease Surveillance
US Environmental Protection Agency (EPA)	EPA's homeland security activities for food and agriculture include the following: —Measures to prevent the use of agricultural materials (such as hazardous pesticides and the equipment used in their application) as terrorist weapons —Measures to protect the security of drinking water and wastewater systems, such as emergency response tools and vulnerability assessments —Information sharing on water security (WaterISAC) —Measures to protect food from biological, chemical, and radiological contamination due to acts of terrorism, e.g., through participation in PrepNet and in federal preparedness exercises —Research and development regarding methods for detecting, treating, and containing biological and chemical warfare agents and bulk industrial chemicals intentionally introduced into drinking water systems	Homeland Security Measures for Agriculture EPA Strategic Plan for Homeland Security Pesticide safety and site security Water Infrastructure Security WaterISAC Emergency response tools
US Department of Homeland Security (DHS): Science and Technology (S&T) Directorate	As the main research and development arm of DHS, S&T directs efforts to enhance scientific and technological capabilities, such as the development of vaccines, antidotes, and therapies against biological and chemical agents, to prevent or mitigate the effects of catastrophic terrorism. Since its start in March 2003, S&T's efforts to enhance food and agricultural biosecurity have focused on: —Assessing the epidemiologic and economic implications of high-consequence terrorism scenarios —Developing key technologies for rapid detection of specific biological and chemical agents —Ccoordinating emergency preparedness plans in response to agroterrorist events —Developing advanced detection and surveillance systems, e.g., the BioWatch program, to permit early detection of the intentional release of human and agricultural pathogens —Developing detection and surveillance systems to identify potential security threats at critical nodes in food processing/production —Engaging the academic community in support of S&T's mission; two Homeland Security Centers of Excellence have been established to conduct multidisciplinary research and to develop innovative educational programs in food and agriculture security	DHS Science & Technology Directorate Homeland Security selects Texas A&M University and University of Minnesota to lead new centers of excellence on agro-security (April 2004 press release)
DHS: Information Analysis and Infrastructure Protection (IAIP) Directorate	Food and agriculture security is included in IAIP's critical infrastructure protection authority, based on provisions outlined in the National Strategy for the Physical Protection of Critical Infrastructure and Key Assets. IAIP's overall responsibilities include: —Integrating all-source threat information —Identify emerging threats and assess their nature and scope —Mapping threats against vulnerabilities, both physical and cyber, to critical infrastructures and key assets —Providing actionable advisories regarding preventive and protective actions —Serving as focal point for coordination between government and critical infrastructure sectors regarding information sharing and emergency response planning Specific activities regarding food and agriculture currently include convening sector-wide workshops focused on: —Developing a framework for information sharing, in coordination with USDA, DHHS, and private sector representatives —Identifying security gaps and strategies for addressing them	DHS Information Analysis and Infrastructure Protection Directorate The National Strategy for the Physical Protection of Critical Infrastructures and Key Assets

Guidelines

Food System Biosecurity Preventive Measures and Guidance
Organization	Guidance Document (with links)	Summary
FDA: Center for Food Safety and Applied Nutrition (CFSAN)	Necessity of the Use of Food Product Categories in Registration of Food Facilities (July 17, 2003)	Guidance regarding the additional inclusion of food product categories in facility registration (according to Section 305 of the Bioterrorism Act) to facilitate investigation and surveillance during emergencies.
FDA: Center for Food Safety and Applied Nutrition (CFSAN)	Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors; Food Security Preventive Measures Guidance (July 11, 2003)	Identifies specific preventive measures that can be taken to minimize the risk of deliberate contamination of fluid milk during production, transportation, and processing.
FDA: Center for Food Safety and Applied Nutrition (CFSAN)	Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (March 21, 2003)	Identifies specific measures that food industry companies (including farms, aquaculture facilities, fishing vessels, producers, transportation operations, processing facilities, packing facilities, and warehouses) can take to protect their products from deliberate contamination and to develop emergency response procedures.
FDA: Center for Food Safety and Applied Nutrition (CFSAN)	Importers and Filers: Food Security Preventive Measures Guidance (March 21, 2003)	Identifies specific measures that operators of food importing establishments, storage warehouses, and filers can take to protect their products from deliberate contamination and to develop emergency response procedures.
FDA: Center for Food Safety and Applied Nutrition (CFSAN)	Retail Food Stores and Retail Food Service Establishments: Food Security and Preventive Measures Guidance (December 17, 2003)	Identifies specific measures to protect retail food from deliberate contamination and to develop emergency response procedures; relevant to operators of retail food stores and food service establishments, including restaurants, grocery stores, cafeterias, day care providers, camps, bakeries, and others.
FDA: Center for Food Safety and Applied Nutrition (CFSAN)	Biosecurity guidance for the dairy industry (March 19, 2003)	Biosecurity controls and procedures aimed at the preventing the introduction and transmission of disease among dairy animals.
USDA: Food Safety and Inspection Service (FSIS)	Food Safety and Security: What Consumers Need to Know (November 17, 2003)	Summary of FSIS' role in the protection of the food supply and of the risk of intentional contamination; includes information on procedures for consumers to report possible food tampering or contamination.
USDA: Food Safety and Inspection Service (FSIS)	Safety and Security Guidelines for the Transportation and Distribution of Meat, Poultry, and Egg Products (August 2003)	Voluntary guidelines aimed at small facilities and shippers that handle meat, poultry, and egg products to prevent physical, chemical, radiological, or microbiological contamination of these products during loading and unloading, transportation, and in-transit storage; focuses on measures designed to prevent unintentional and as well as intentional contamination.
USDA: Food Safety and Inspection Service (FSIS)	Security Guidelines for Food Processors (April 2002)	Identifies security measures to assist plants that produce meat, poultry, and egg products; includes security plan management and specific security issues regarding facilities, shipping and receiving, water and ice supply, mail handling, and personnel.
USDA: food Safety and Inspection Service (FSIS)	FSIS Directive 5420.1—Homeland Security Threat Condition Response - Food Security Monitoring Procedures (March 17, 2003) FSIS Directive 5420.2—Homeland Security - Handling of FSIS Laboratory Samples under Declared Heightened Threat Conditions (June 18, 2003)	These directives outline the emergency procedures that FSIS inspection program personnel will follow, and the steps that FSIS laboratories will initiate in the event that FSIS laboratory samples must be handled, under heightened threat conditions (DHS Code Orange or Red).
World Health Organization (WHO): Food Safety Department	Terrorist Threats to Food: Guidance for Establishing and Strengthening Prevention and Response Systems (2002)	Guidance regarding establishment and enhancement of existing food safety management programs and security measures; provides policy advice on strengthening existing emergency alert and response systems; summarizes WHO's public health role in responding to food safety emergencies.

Food Emergency Response Network (FERN)

The Food Emergency Response Network (FERN) is a system of laboratories designed to provide expertise and facilities for identifying biological, chemical, and radiological contaminants specifically in food products (FDA 2003). Begun in 2003, FERN is aimed at enhancing capabilities nationwide for assessing and responding to potential food biosecurity incidents by coordinating specific food-related methodologies, training programs, equipment, and surge capacity at existing facilities. It was developed by federal agencies [primarily the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the US Department of Agriculture (USDA)] in collaboration with the states. State laboratories for public health, agriculture, or veterinary diagnostics provide initial access to FERN facilities. Participating facilities include:

• National and regional government laboratories under the jurisdiction of FDA, USDA, the Environmental Protection Agency, and the Department of Energy
• State public health, agriculture, and veterinary diagnostic laboratories
• County public health laboratories
• University laboratories

With 63 laboratories participating (as of Nov 2003), the FERN system is subdivided into three specialized networks according to the types of agents analyzed:

• Biological laboratories, comprising 38 state and federal laboratories
• Chemical laboratories, including 8 federal laboratories
• Radiological laboratories, comprising 17 state, federal, and university laboratories (see References: FDA: Counter-terrorism food emergency response network; FDA 2003—the progress report).

A secure, Web-based data communication system, eLEXNET, is used to coordinate findings among the laboratories and to provide an alert system for food biosecurity emergencies. To help integrate additional state food laboratories into FERN, CDC and FDA recently announced the availability of continuation funds for cooperative agreements between CDC and state health departments to purchase specialized equipment and reagents and to provide additional training for laboratory personnel (see References: FDA 2003—the fact sheet; Crawford 2003).

Information Sharing and Analysis

Many critical infrastructure sectors, including those owned and operated largely by the private sector, have developed centralized mechanisms to share security-related information and expertise, such as confidential data on threats and suspicious incidents, information about threats or attacks elsewhere in the system, and guidance on effective responses to crisis situations.

In 1998, PDD-63 called for the establishment of private sector information sharing and analysis centers (ISACs) as part of a coordinated, non-regulatory effort between government and the private sector to counter emerging national security threats to the nation's critical infrastructures. Food and agriculture were specified as critical infrastructures in subsequent homeland security documents, in recognition of the food system's critical role in public health and safety (see section above).

Prior to the creation of DHS, two federal organizations—the Critical Infrastructure Assurance Office (CIAO) in the Department of Commerce, and the National Infrastructure Protection Center (NIPC) in the Federal Bureau of Investigation (FBI)—worked with a variety of private sector entities to develop ISACs (see References: DHS ISAC). In an effort to develop an ISAC for the food industry, NIPC collaborated with the Food Marketing Institute (FMI), a food industry trade association, in early 2002. FMI initiated an online information-sharing service whereby trade association members can voluntarily submit incident reports to NIPC (now part of DHS) and NIPC provides food industry–related threat and warning information to the trade associations via FMI (see References: FMI).

In early 2003, in an independent initiative, the University of Minnesota organized a strategic planning committee, composed of senior executives and scientific leaders from food and agriculture companies, to assess the need for a farm-to-table information sharing and analysis mechanism, and if necessary, to design its structure. In July 2003, the committee affirmed the urgent need for a neutral, sector-wide mechanism for gathering, sharing, and analyzing biosecurity information to allow the industry to anticipate and respond to potential threats. The committee emphasized that direct engagement of private sector companies is needed to effectively address this issue. Critical components of the committee's plan included confidential information gathering and sharing, science-based analysis, event response, and specialized education and training programs. In September 2003 the committee approved a business plan for an independent, member–lead, nonprofit information sharing and analysis organization based on these components (see References: CIDRAP).

DHS' IAIP Directorate, which incorporated both CIAO and NIPC, is currently coordinating ISAC development through its Infrastructure Coordination Division (ICD). As stated in HSPD-9, DHS, in collaboration with the lead sector agencies DHHS and USDA, is tasked with coordinating the development of an information sharing and analysis mechanism in the food and agriculture sector. At present, ICD is working with representatives from DHHS, USDA, and food and agriculture industries to develop a governance structure to oversee the sector's information sharing and analysis activities.

References

CIDRAP/University of Minnesota. Ongoing food biosecurity work at CIDRAP [Full text]

Crawford LM. Statement before the US Senate Committee on Governmental Affairs, Nov 19, 2003 [Full text]

DHS. Broad Agency Announcement: Homeland Security Center for Foreign Animal and Zoonotic Disease Defense and Homeland Security Center for Post-Harvest Food Protection and Defense. Dec 11, 2003

DHS. Homeland Security Selects Texas A&M University and University Of Minnesota to Lead New Centers of Excellence on Agro-Security [Full text]

DHS. Information sharing and analysis centers [Web page]

Executive Order 13228. Order establishing Office of Homeland Security. Oct 8, 2001 [Full text]

FDA. Administrative detention of food for human or animal consumption under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Rule. Fed Reg 2002 Jun 4;68(108):31659-705 [Full text]

FDA. Fact sheet on FDA's new food bioterrorism regulation final rule: Administrative detention. May 2004 [Full text]

FDA. Bioterrorism Act of 2002 [Web page]

FDA. Counter-terrorism food emergency response network [Full text]

FDA. FDA and CBP announce their transitional compliance policy
on food imports under the Bioterrorism Act. Press release. Dec 11, 2003 [Full text]

FDA. FDA actions on new bioterrorism legislation [Web page]

FDA. HHS announces new funding opportunity for state food labs. May 8, 2003 [Full text]

FDA. Interim final rule on registration of food facilities. Oct 10, 2003 [Full text]

FDA. Interim final rule—Prior notice of imported food shipments. Fact sheet. Oct 2003 [Full text]

FDA. Interim final rule—Registration of food facilities. Fact sheet. Oct 2003 [Full text]

FDA. Plans for developing bioterrorism-related food regulations [Web page]

FDA. Prior notice of imported foods: prior notice system interface [Web page]

FDA. Progress report to Secretary Tommy G. Thompson: ensuring the safety and security of the nation's food supply. Jul 23, 2003 [Full text]

FDA. Proposed regulations: establishment and maintenance of records. May 2003 [Web page]

FDA. Registration of food facilities; electronic registration via the Internet. Oct 2003 [Web page]

FDA. Testing for rapid detection of adulteration of food. Report to Congress. Oct 2003 [Full text]

FMI (Food Marketing Institute). Food and agriculture ISAC [Web page]

GAO. Information sharing responsibilities, challenges, and key management issues. GAO-03-1165T. Sep 17, 2003 [Full text]

HSPD-7 (Homeland Security Presidential Directive 7). Critical infrastructure identification, prioritization, and protection. Dec. 17, 2003 [Full text]

HSPD-9 (Homeland Security Presidential Directive 9). Defense of United States agriculture and food. Jan 4, 2003 [Full text]

Presidential Decision Directive 63. The Clinton Administration's Policy on Critical Infrastructure Protection. May 1998 [Full text]

Public Law 107-17. Farm Security and Rural Investment Act of 2002 (Farm Bill) [Full text]

Public Law 107-188. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) [Full text]

USDA/FSIS. Protecting America's meat, poultry, and egg products: a report to the Secretary of the Food Safety and Inspection Service, 2003 [Full text]

White House. National Strategy for Homeland Security, July 2002. [Full text]

White House. National Strategy for the Physical Protection of Critical Infrastructures and Key Assets, Feb 2003. [Full text]