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Appendix D
The U.S. Food and Drug Administration’s Food Defense Program1

This appendix describes the U.S. Food and Drug Administration’s (FDA’s) food defense program from 2001 to the present. It places bioterrorism within the broader context of terrorism and the associated legal and organizational framework. It also describes the formal and informal cooperation between the FDA and other groups and organizations involved in food defense, including the creation of a government–industry partnership. Outcomes of this partnership were the development of a risk vulnerability assessment model and its application in the food industry. The appendix also reviews the issues that arise in, and approaches to, acquiring and sharing food defense data. Examples of the capacity of the FDA to respond to emergencies are provided as well. Further, the appendix describes how the FDA’s 2007 Food Protection Plan (FPP) includes food defense in its goals. The progress made to date with regard to management of food defense is described, and gaps are identified. The appendix concludes with a summary and a list of opportunities for improvement in maximizing the outcomes of the industry–government partnership, developing tools for prioritization of risks, maintaining resources, and enacting needed legislation.

This appendix was written based on information gathered from interviews with representatives of federal and state government, academia, and industry; public documents from both government and industry sources; and the author’s experience and expertise in food defense as former Deputy

1

 Louis Carson, Retired, FDA; former Deputy Director of the FDA Center for Food Safety and Applied Nutrition’s Office of Food Safety, Defense, and Outreach.



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Appendix D The U.S. Food and Drug Administration’s Food Defense Program 1 T his appendix describes the U.S. Food and Drug Administration’s (FDA’s) food defense program from 2001 to the present. It places bioterrorism within the broader context of terrorism and the associ- ated legal and organizational framework. It also describes the formal and informal cooperation between the FDA and other groups and organizations involved in food defense, including the creation of a government−industry partnership. Outcomes of this partnership were the development of a risk vulnerability assessment model and its application in the food industry. The appendix also reviews the issues that arise in, and approaches to, acquiring and sharing food defense data. Examples of the capacity of the FDA to respond to emergencies are provided as well. Further, the appendix describes how the FDA’s 2007 Food Protection Plan (FPP) includes food defense in its goals. The progress made to date with regard to manage- ment of food defense is described, and gaps are identified. The appendix concludes with a summary and a list of opportunities for improvement in maximizing the outcomes of the industry−government partnership, devel- oping tools for prioritization of risks, maintaining resources, and enacting needed legislation. This appendix was written based on information gathered from inter- views with representatives of federal and state government, academia, and industry; public documents from both government and industry sources; and the author’s experience and expertise in food defense as former Deputy 1 Louis Carson, Retired, FDA; former Deputy Director of the FDA Center for Food Safety and Applied Nutrition’s Office of Food Safety, Defense, and Outreach. 0

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0 ENHANCING FOOD SAFETY Director of the FDA Center for Food Safety and Applied Nutrition’s (CFSAN’s) Office of Food Safety, Defense, and Outreach. Where compre- hensive source materials were unavailable, the discussion relies on anec- dotal information and inferences from program directives. BUILDING A FOOD DEFENSE PROGRAM “Food defense” is the collective term used by the FDA, the U.S. Depart- ment of Agriculture (USDA), the U.S. Department of Homeland Security (DHS), and others to describe activities associated with protecting the nation’s food supply from deliberate acts of contamination. Shortly after September 11, 2001, the FDA and other federal agencies began developing a new program, building on a program initiated by the U.S. Department of Health and Human Services (HHS), to protect the nation’s food supply from terrorist attacks. The FDA focused its efforts on targeted industry guidance and outreach, inspections, research (e.g., methods development and valida- tion, characteristics and behavior of agents in foods, pathogenicity/toxicity in foods), and mitigation strategies to reduce potential risks in the food supply. Numerous organizations, public and private, have played a role in the FDA’s food defense program to date (see Annex Table D-1). The FDA used operational risk management (ORM) as a tool to iden- tify food defense priorities. ORM is a management tool used by the U.S. Departments of Defense (DoD) and Transportation to identify risks and reduce them to an appropriate level, ensuring that benefits will outweigh any risks. It is an analytical tool whereby severity and probability (acces- sibility) of risk are measured qualitatively and assigned a rating—high, medium, or low (see Table D-1). A CFSAN team of scientific and food production experts was charged with testing the tool on a list of threat agents, starting with the list of the U.S. Centers for Disease Control and Prevention (CDC) and expanded to other known or potential threat agents, in combination with a list of FDA- regulated foods. The class groupings were, for example, heat-labile bacte- rial toxins, heat-stable bacterial toxins, and spore-forming bacteria. The agents (surrogates) were also assessed on their accessibility, public health impact (morbidity and mortality), toxicity/pathogenicity, dose required to cause intended outcome, agent−food compatibility, ability to withstand processing, and changes to sensory attributes of food. (The resulting list of prioritized agent−food combinations is classified and unavailable for this discussion.) This risk assessment effort, early in the evolution of the food defense program, was crucial to identifying a finite list of agent−food combinations for further investigation and helped in understanding the potential hazards. Equipped with this risk assessment tool, the FDA focused

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0 APPENDIX D TABLE D-1 Risk Assessment Tool: Operational Risk Management Probability Frequent Likely Occasional Seldom Unlikely Severity A B C D E Catastrophic I 1 2 6 8 12 Critical II 3 4 7 11 15 Moderate III 5 9 10 14 16 Negligible IV 13 17 18 19 20 Risk Levels NOTES: Catastrophic—Complete business failure due to food product contamination, resulting in deaths. Critical—Major business degradation due to food product contamination, resulting in severe illnesses. Moderate—Minor business degradation due to food product contamination, resulting in minor illnesses. Negligible—Less than minor business degradation and illnesses. Frequent—Occurs often to individuals, and population is continuously exposed. Likely—Occurs several times, and population is exposed regularly. Occasional—Will occur and occurs sporadically in a population. Seldom—May occur and occurs seldom in a population. Unlikely—So unlikely one can assume it will not occur, and occurs very rarely in a population. its resources on identifying the greatest vulnerabilities and opportunities for reducing risk in the food supply. The FDA, with the voluntary participation of food industry trade associations, subsequently conducted a series of ORM exercises. With the information thus gathered, physical security, employee, management, and quality assurance practices were identified and published in a series of Food Security Preventive Measures Guidance documents for Industry for Food Producers, Processors, and Transporters; Dairy Farms, Bulk Milk Trans- porters, Bulk Milk Transfer Stations, and Fluid Milk Processors; Retail Food Stores and Food Service Establishments; Importers and Filers; and Cosmetic Processors and Transporters. In turn, many food industry trade associations and food producers updated their facility quality assurance or crisis management plans to incorporate these features. In an effort to further assist the industry, the outreach effort was broad in scope, encompassing all FDA-regulated food producers from farm to table. Equally important was training the FDA’s own investigators and field scientists in this new threat—intentional contamination of the food sup- ply. Training materials, face-to-face sessions, and web-based courses were developed to educate the industry and the FDA’s food safety experts and to share this information with their state and local counterparts.

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0 ENHANCING FOOD SAFETY At the outset of this new food defense program, the FDA and its food safety/defense counterparts at CDC, USDA’s Food Safety and Inspection Service (FSIS), DoD/Army Veterinary Corps, and the U.S. Environmental Protection Agency (EPA) were embarking on different paths, many using established food safety risk assessment methodologies, to protect the food supply. With the FDA’s novel approach, it was prudent to ensure rigor and scientific soundness, and the risk-ranking list of agent–food combinations and the ORM tool were subjected to peer review through a contract with the Institute of Food Technologists. When the risk-ranking list and the ORM tool passed this review, the FDA further augmented its outreach to its federal and state partners and enhanced training and outreach efforts with the food industry, given their mutual responsibilities for dealing with potential food safety events. HOMELAND SECURITY AND FOOD DEFENSE In 2003, with the formation of DHS, emphasis was placed on infra- structure protection, a National Infrastructure Protection Plan (NIPP), a National Response Plan (NRP), and the overarching mandate to engage public and private entities in homeland security as described in various Homeland Security Presidential Directives (HSPDs). The FDA and its fed- eral partners were challenged not only to build a working relationship with a new entity—DHS—but also, in an expedited manner, to build a food and agriculture public–private partnership; fully develop and implement a voluntary national defense program to protect the food supply from inten- tional contamination; update all current emergency response procedures, including those involving the new DHS; and train and educate their staff and regulated industries in this new program. Adding to the FDA’s tasks, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act of 2002),2 which required the agency to expedite rule making for 4 new authorities and implement those authorities within a time frame of 18 months. The new authorities were registration of domestic and foreign food producers, manufactures, and distributors; prior notice of imported food shipments; record-keeping requirements; and administrative detention (see Table D-2). Given the timetable for publication and implementation of the draft rules, the FDA faced a monumental outreach and education effort in providing the necessary materials and details in simple language to enable all to comply. During the 2003−2005 time frame, the FDA/CFSAN was engaged in activities to comply with the HSPDs and congressional 2 Public Health Security and Bioterrorism Preparedness and Response Act of 00, Public Law 107-188, 107th Cong., 2nd sess. (June 12, 2002).

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0 APPENDIX D TABLE D-2 Provisions of the Bioterrorism Act of 2002 Relating to the U.S. Food and Drug Adminisration (FDA) Registration of Requires food manufactures, processors, holders, and distributors to food facilities register each facility, not company, with the FDA. The registration coverage is limited and does not encompass farm to table, specifically excluding farms and retail establishments. Prior notice of The FDA must receive and confirm a prior notice imported food shipments • no more than 30 days before a shipment’s anticipated arrival, if prior notice is submitted via Automated Broker Interface, or • no more than 15 days before a shipment’s anticipated arrival, if prior notice is submitted via the FDA’s Prior Notice System Interface. Record keeping Requires each domestic food manufacturer, processor, holder, or distributor food/feed facility to retain records of incoming ingredients and supplies and of outgoing products. Administrative Gives the FDA domestic embargo authority, whereby suspect or detention contaminated food in commercial channels can be stopped until judicial action is taken to seize and/or destroy it. legislative requirements, and to educate and communicate with industry, its own staff, and state, local, and foreign counterparts. The FDA’s outreach efforts leveraged all media opportunities to educate industry and state and foreign governments in the new regulations and food defense program. The FDA teamed with USDA to develop joint food defense training materials and promoted their adoption by industry and the states. The latter effort was focused on generating awareness of the new food defense program and training food safety professionals to be the eyes and ears for potential threats to the food supply. Awareness training included how to identify potentially intentional contamination and whom to notify, as well as information about the implications of a terrorist attack on the U.S. food supply (including production agriculture). The training was offered both as a web-based course (FDA, 2009a) and in face-to-face sessions. Later, as part of this training, the FDA and USDA developed simplified tools, such as ALERT (FDA, 2009b), intended to raise awareness at all levels of food production, and FIRST (FDA, 2009c), designed for use by food indus- try managers to educate front-line workers from farm to table.

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0 ENHANCING FOOD SAFETY ESTABLISHMENT OF A PARTNERSHIP: THE FOOD AND AGRICULTURE SECTOR By Presidential Directive, FDA/USDA and the newly formed DHS were required to establish a sector organization, that is, a partnership with all relevant federal, state, local, and industry counterparts. Although there were existing models for such a partnership in other areas, none were suit- able given the diversity, scope, and magnitude of the food and agriculture sector. The FDA/USDA/DHS, with industry, formulated a governing model and operating procedures for the new Food and Agriculture Sector, with the goal of identifying and protecting critical infrastructure assets and establishing a two-way communication and analysis system to inform and notify members and analyze critical food defense information. The Food and Agriculture Sector partnership comprises two governing councils: (1) the Government Coordinating Council (GCC) and (2) the Sector Coor- dinating Council (SCC) (representing industry). The membership of each council was expanded over time. In addition, seven subcouncils were cre- ated under the SCC so that each industry segment—harvest, production, Food and Agriculture Sector Food and Agriculture Government Coordinating Council (GCC) Coordinating Council (SCC) • Depar tment of Agriculture* • Depar tment of Health and Human Services- SCC Sub-Councils Food and Drug Administration* • Depar tment of Homeland Security • Producers/Plant Sub-Council • Depar tment of Defense • Environmental Protection Agency • Producers/Animal Sub-Council • Depar tment of Commerce • Depar tment of Justice • Depar tment of Interior • Processors/Manufacturers Sub-Council • Assoc. of State & Territorial Health Officials • Nat’l. Assoc. of State Depts of Agriculture • Restaurants/Food Ser vice Sub-Council • National Environmental Health Association • National Plant Board • Retail Sub-Council • Nat’l. Assembly of State Chief Livestock Health Officials • Assoc. of Food & Drug Officials • Warehousing and Logistic Sub-Council • Nat’l. Assoc. of City & County Health Officials • Intertribal Agriculture Council • Agriculture Production Inputs and Ser vices • American Assoc. of Veterinary Laboratory Diagnosticians Sub-Council • Assoc. of Public Health Laboratories • State, Local, Tribal, & Territorial GCC FIGURE D-1 Participant organizations of the Food and Agriculture Government Coordinating Council and Sector Coordinating Council. NOTE: In the summer of 2009, the subcouncils integrated into one large council. *Sector specific agencies for the Figure D-1 Food and Agriculture Sector. R01720 color editable vector image

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0 APPENDIX D retail, distribution, and supply—would have a voice (see Figure D-1), and they were dissolved later in 2009. Since its inception, the program has relied on voluntary participation and engagement by the states and industry. The GCC was established to enable interagency coordination of food and agriculture security strategies and activities, policy, and communica- tion across government and between the government and each sector, with the goal of developing consensus approaches to the protection of critical infrastructure/key resources. DHS, FSIS, and the FDA co-chaired the GCC, each serving as its lead for 12 months on a rotating basis. The SCC is self- organized, self-run, and self-governed. It is composed of members that serve as the GCC’s point of contact for each industry sector (i.e., plant and animal producers, manufacturers, restaurants, retail, warehouses, and agricultural production) for developing and coordinating a wide range of infrastructure protection activities and issues (e.g., research and development, outreach, information sharing, vulnerability assessments/prioritization, shielding, and recovery). Regular conference calls and quarterly meetings of the GCC and SCC addressed organizational issues, communication efforts, emergency opera- tions, training and planning, identification of annual priorities, and partici- pation in such activities as emergency response exercises, the development of risk communication templates, and a Strategic Partnership Program Agroterrorism (SPPA) initiative, all in an effort to contribute to an overall NIPP (see Annex D-3 for an overview of SPPA). CARVER + Shock as a Tool to Conduct Vulnerability Assessments Under the auspices of the White House Homeland Security Council, the White House Interagency Food Working Group was formed with representatives from various federal agencies (e.g., USDA, EPA, HHS, DoD) to discuss issues across all of the administration’s food programs. To com- prehensively assess the food and agriculture supply, the group agreed that a single risk assessment model/tool—CARVER + Shock—would be used to harmonize all food and agriculture−related agency efforts. CARVER + Shock, a military special operations forces acronym, enables cross-sector assessment of risks and vulnerabilities. The tool rates seven fac- tors that affect the desirability of a target: 1. Criticality—public health or economic impact 2. Accessibility—physical access to target 3. Recuperability—ability of the system to recover from an attack 4. Vulnerability—ease of accomplishing the attack 5. Effect—amount of actual direct loss from the attack 6. Recognizability—ease of identifying target

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0 ENHANCING FOOD SAFETY . Shock—combined measure of physical, health, psychological, and economic effects o CARVER + Shock enabled more in-depth analysis of a food production and distribution process and its vulnerabilities, while also adding the new factor of shock not considered in ORM assessments. The FDA and its counterparts had to learn this new tool and apply it to work already completed—termed “verifications”—and extend the assessment effort to cover new food and agriculture scenarios. These efforts again formed the foundation for strategic priorities, research directions, risk communication needs, and subsequent advice to industry with respect to food defense. With congressional funding for security assessments of food and agri- culture facilities, the Federal Bureau of Investigation (FBI) teamed with the FDA/USDA and DHS to harmonize food defense and law enforcement goals. CARVER + Shock was applied to a wide variety of high-priority food commodities in collaboration with state, federal, and industry experts on a facility-by-facility basis, and SPPA was launched. The Food and Agriculture Sector was viewed as the logical point of contact with industry to seek its voluntary participation in this endeavor. GCC co-chairs, SCC chairs, and the FBI developed SPPA so that issues of proprietary processes and potentially sensitive information would be handled properly. Findings or reports would be reviewed and approved by both industry and government before being issued as public documents, while government would retain the sensitive/ classified assessments. A sufficient level of trust had been built within the Food and Agriculture Sector to accommodate this assessment program in what would become one of the Sector’s major accomplishments. These assessments supported the requirements for a coordinated food and agriculture infrastructure protection program as stated in the NIPP; Sector-Specific Plans (SSPs); National Preparedness Guidelines (released in 2007); and HSPD-9, Defense of U.S. Agriculture and Food. Using CARVER + Shock, SPPA assessments were conducted on a voluntary basis among one or more industry representatives for a particular product or commodity, their trade association(s), and federal and state agricultural, public health, and law enforcement officials. As a result of each assessment, participants identified individual nodes or process points that were of greatest concern, protective measures and mitigation steps that could reduce the vulnerability of these nodes, and research gaps/needs. Discussions of mitigation steps and good security prac- tices were general in nature, focusing on physical security improvements for food processing facilities, biosecurity practices, and disease surveillance for livestock and plants. The results can be found in the 2008 SPPA final report summary, Strategic Partnership Program Agroterrorism (SPPA) Initiatie: Final Summary Report, September 00–September 00 (FDA, 2009d).

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 APPENDIX D From 2005 to 2007, 36 SPPA assessments were conducted on a variety of food and agriculture products, processes, or commodities. These assess- ments covered 1 or more of the SCC subcouncils’ commodities and were completed in 31 of the 52 key sites identified under the SPPA initiative. Each SPPA assessment lasted approximately 3 days and was conducted by a team of 20 to 30 participants from federal, state, and local agricultural, food, public health, and law enforcement agencies; food and agriculture companies; and their trade associations. In preparation for the assess- ment, the USDA or FDA federal host (Sector-Specific Agency [SSA]) and a representative of FBI headquarters provided background and educational material. This material ensured that participants were knowledgeable about the CARVER + Shock assessment tool and plans for the assessment. Recur- ring themes included the need for • better understanding of threat agent characteristics; • better scientific capabilities, such as the development or improve- ment of detection methods for threat agents of concern; • development or dissemination of models (or their results) related to the impact of a food or agricultural terrorism event; • improved communications; and • identification of gaps in evaluating economic impacts and effects on consumer confidence. In addition to identifying gaps in knowledge, the tool has been used to determine commonalities across food and agricultural industries that make them more vulnerable to attack, allowing for the proposal of generic protective measures or mitigation strategies that could be beneficial to the industries assessed. The SPPA initiative was a significant step toward hardening of critical infrastructure and greater protection of the food and agriculture industries. This was accomplished by providing industry members with training and hands-on experience with a terrorism-focused assessment. The SPPA initia- tive also provided federal, state, and local governments with an in-depth look at the vulnerabilities that may be associated with different facets of the food and agriculture industries. Finally, the initiative increased commu- nication among industry, government, and law enforcement stakeholders concerned with the safety and security of the food supply. To further assist industry and state and local government officials, various guidance has been published, such as USDA’s Guidelines for the Disposal of Intentionally Adulterated Food Products and the Decontami­ nation of Food Processing Facilities (FSIS, 2006) and EPA’s Federal Food and Agriculture Decontamination and Disposal Roles and Responsibilities

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 ENHANCING FOOD SAFETY (EPA, 2005). In addition, the FDA released a free software version of the CARVER + Shock assessment tool (FDA, 2009e). Information Sharing The Food and Agriculture Sector has made many attempts to find a suitable communication tool that fully supports its activities. Although the Food Marketing Institute3 (FMI) supported the Food and Agriculture Sector Information Sharing and Analysis Center as a mechanism for sharing data, FMI lacked sufficient private funds to offer more than a clearinghouse/ e-mail notification system. While this was useful in the Sector’s early days, a more robust system was needed as its activities matured and broadened. DHS and its component organizations developed several other informa- tion and analysis systems, such as the Homeland Security Information Net- work (HSIN). After almost 2 years of HSIN operation, staff have made the following recommendations for improving communications and Food and Agriculture Sector operations. First, hire a data manager to actively poll and issue information to all Sector representatives, who would in turn issue this information to all subsectors/members. Use HSIN and FoodShield, a network designed by and located at the National Center for Food Protec- tion and Defense (NCFPD), as mechanisms for communication. Second, re-fund SPPA as a joint FBI/DHS/FDA/USDA initiative to conduct CARVER + Shock assessments at food facilities, with state participation. Third, fund full-time positions to carry out state food defense activities. It was also suggested that DHS’s Homeland Infrastructure Threat and Risk Analysis Center’s annual infrastructure resource assessment is not serving Food and Agriculture Sector needs, even with more than 30 states using the current Food and Agriculture Sector Criticality Assessment Tool (FASCAT). The collection of sensitive information continues to be a challenge. The FDA and its counterparts are subject to Freedom of Information Act4 (FOIA) requirements and must disclose information upon request unless it is excluded by a confidential business interest or is classified. Further, the FDA is subject to Paperwork Reduction Act5 provisions, which require justification to solicit, survey, or ask questions of consumers, industry, and others. Industry has been reluctant to share technical and production infor- mation for fear it would be available to the public through FOIA. Thus it is difficult to obtain survey data on industry practices. To overcome industry’s 3 The FMI is a trade association representing food retailers and wholesalers that develops and promotes policies, programs, and forums supporting its members and their customers in the areas of government relations, food safety and defense, public and consumer information, research and education, and industry cooperation. 4 Freedom of Information Act, Title 5 U.S. Code § 552. 5 Paperwork Reduction Act, Title 44 U.S. Code § 3501.

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 APPENDIX D reluctance to share technical and production information, a process to pro- tect the information from FOIA, state and local disclosure laws, and civil lawsuits (DHS, 2009) was conceived—the Protected Critical Infrastructure Information (PCII) process. With this DHS/PCII process, the FDA has an avenue to receive and secure industry data. But the DHS/PCII data collec- tion process requires substantive justification and industry cooperation. Further, DHS/PCII must concur in the agency’s request so the request can receive an expedited and abbreviated Office of Management and Budget review. The FDA has employed PCII in only two instances, in 2006 and 2008–2009, to survey milk processors in the United States, as discussed further in a later section. The classification and sharing of sensitive information related to food defense have been both a burden and a blessing. HHS Secretary Tommy Thompson, meeting with state public health officials, promised that HHS would seek a secret-level clearance for each state health department, usually the director. However, receiving a security clearance has been a challenge given the volume of requests made at the federal, state, and industry levels; the fact that many high-level officials are appointees with frequent turnover; and the strict standards for gaining a clearance that are not always met. In the case of the Food and Agriculture Sector, the GCC co-chairs and SCC chairs have received security clearances, as have some subcouncil and task force members. Even with a security clearance, however, every individual is not assured of access to all classified information. Classified information is available only on a need-to-know basis. For purposes of the Food and Agriculture Sector, classified information6 is not available to the public. It may be gleaned from confidential sources or from compilations or analyses of existing public data that in the view of the government organization meet the definition of Title 18 of the U.S. Code. Classified information generated by the FDA and other government agencies is secured from public access, stored in secure rooms or vaults, and accessed using a stand-alone, non-network computer or device. Like all government agencies, the FDA has specific procedures for transport- ing classified documents and for their storage or use. The FDA’s Office of Crisis Management (OCM) is responsible for establishing and enforcing the agency’s security rules. The FDA must maintain a log and document all access to classified materials. The agency is subject to a security audit on an annual basis, and adherence to procedures is strictly enforced. As noted 6 According to Title 18 U.S.C., (1) classified information is “any information or material that has been determined by the United States Government pursuant to an Executive order, statute, or regulation to require protection against unauthorized disclosure for reasons of national security and any restricted data, as defined in paragraph r. of section 11 of the Atomic Energy Act of  (42 U.S.C. 2014 (y))”; and (2) “national security . . . means the national defense and foreign relations of the United States.”

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0 ENHANCING FOOD SAFETY Recommendations To address the findings in this report, we recommend that the FDA: • Seek statutory authority, if necessary, to strengthen existing records requirements regarding lot-specific information. • Consider seeking additional statutory authority to improve traceability. • Work with the food industry to develop additional guidance to strengthen traceability. • Address issues related to mixing raw food products from a large number of farms. • Seek statutory authority to conduct activities to ensure that facili- ties are complying with its records requirements. • Conduct education and outreach activities to inform the food industry about its records requirements. ANNEx D-5 BUDGET REqUEST FOR THE FOODS PROGRAM The FY 2010 President’s Budget requests $845,617,000 in program level funding for the Foods Program, including user fees, in the support of 3,516 FTEs. The CFSAN portion of the request is $244,981,000 and 947 FTEs, an increase above the FY 2009 Omnibus of $34,495,000 and an increase of 93 FTEs to maintain current service levels. The Field portion of the request is $600,636,000 supporting 2,569 FTEs, an increase above the FY 2009 Omnibus of $162,400,000 and 404 FTEs. In FY 2010, CFSAN will continue to take the lead in maintaining and improving an already sound food safety protection capability by accom- plishing the goals and objectives established in the FDA FPP and the Import Safety Action Plan as well as continuing cooperation and information shar- ing between the United States and China. The FDA envisions establishing a new strategic framework for an inte- grated national food safety system. In order to efficiently and effectively establish a fully integrated national food and feed safety system, the FDA must build and expand existing programs and relationships with its regu- latory partners, specifically its federal, state, local, tribal, and territorial partners. The FDA is requesting funding in FY 2010 to begin establishing the necessary infrastructure for the Field Food and Feeds Programs in the following four areas:

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 APPENDIX D 1. Develop a National Work Plan that includes the inspections of food manufacturing and distribution facilities and the collection and analyses of compliance, surveillance, and environmental samples. 2. Ensure that programmatic objectives and implementation are coordinated. 3. Continue to develop uniform national standards for such subjects as manufacturing, inspections, and enforcement. 4. Build training courses and a certification program to be delivered to state, local, and tribal regulatory partners, and increase program- matic oversight and develop a more robust audit program. A system of this magnitude may require new authorizations such as multi-year budget authority for federal, state, local, tribal, and territorial regulatory partners and the authority to share non-public information with our regulatory partners when it is necessary to protect public health. However, this request is necessary to begin building the framework for an integrated national food safety system. Furthermore, ORA is requesting funding in FY 2010 to continue build- ing its workforce for more field food and feed work and support for the field food and feed work. In order to do so, ORA is requesting funding to continue hiring investigators, analysts, and support staff in order to con- tinue to increase field and food work, such as: • an increase of 20,000 food and feed import exams by the end of 2011, • an increase of 2,000 domestic food and feed inspections by the end of 2012, and • an increase of 50 foreign food and feed inspections by the end of 2012. REFERENCES DHS (U.S. Department of Homeland Security). 2009. Protected Critical Infrastructure In­ formation (PCII) Program. http://www.dhs.gov/files/programs/editorial_0404.shtm (ac- cessed October 2, 2009). EPA (U.S. Environment Protection Agency). 2005. Federal Food and Agriculture Decon­ tamination and Disposal Roles and Responsibilities. http://www.epa.gov/OHS/pdfs/ conops11222005.pdf (accessed October 2, 2009). FDA (U.S. Food and Drug Administration). 2009a. ORA Uniersity (ORAU). http://www.fda. gov/Training/ForStateLocalTribalRegulators/default.htm (accessed October 2, 2009). FDA. 2009b. ALERT: The Basics. http://www.fda.gov/Food/FoodDefense/Training/ALERT/ default.htm (accessed October 2, 2009). FDA. 2009c. Employees FIRST: Food Defense Awareness for Front­Line Food Industry Workers. http://www.fda.gov/Food/FoodDefense/Training/ucm135038.htm (accessed October 2, 2009).

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 ENHANCING FOOD SAFETY FDA. 2009d. Strategic Partnership Program Agroterrorism (SPPA) Initiatie: Final Sum­ mary Report September 00–September 00. http://www.fda.gov/Food/ FoodDefense/ FoodDefensePrograms/ucm170509.htm (accessed October 2, 2009). FDA. 2009e. CARVER + Shock. http://www.fda.gov/Food/FoodDefense/CARVER/default.htm (accessed October 2, 2009). FDA. 2009f. Food Defense and Emergency Response. http://www.fda.gov/Food/FoodDefense/ default.htm (accessed October 2, 2009). FSIS (Food Safety and Inspection Service). 2006. Guidelines for the Disposal of Intention­ ally Adulterated Food Products and the Decontamination of Food Processing Facili­ ties. http://www.fsis.usda.gov/PDF/Disposal_Decontamination_Guidelines.PDF (accessed October 2, 2009). Wein, L., and Y. Liu. 2005. Analyzing a bioterror attack on the food supply: The case of botulinum toxin in milk. Proceedings of the National Academy of Sciences 102(28):9984–9989.

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 APPENDIX D ANNEx TABLE D-1 Participants in the Food Defense Program White House Interagency Food An interagency working group consists of representatives from Working Group multiple federal agencies (e.g., U.S. Department of Agriculture [USDA], U.S. Environmental Protection Agency [EPA], U.S. Department of Health and Human Services [HHS], U.S. Department of Defense [DoD]) empaneled to discuss issues related to a particular topic. This group was formed under the White House Homeland Security Council. HHS Office of Public OPHEP serves as the principal advisory staff to the Secretary Health Emergency of HHS on matters related to bioterrorism and other public Preparedness health emergencies. It coordinates interagency activities among (OPHEP) HHS; other federal departments, agencies, and offices; and state and local officials responsible for emergency preparedness and protection of the civilian population from acts of bioterrorism and other public health emergencies. U.S. Centers for CDC identifies foodborne illnesses and leads HHS efforts Disease Control and in bioterrorism. CDC works with the U.S. Food and Drug Prevention (CDC) Administration (FDA) and/or USDA to conduct follow-up on foodborne illness events and coordinate emergency response and surveillance activities. CDC’s Laboratory Response Network is a network of state public health laboratories developed to provide surge capacity for samples resulting from a public health emergency caused by a selected agent. Its counterpart, the FDA/ USDA Food Emergency Response Network (FERN), comprises laboratories that perform testing and analysis for selected agents when foods, feeds, and associated materials are implicated. continued

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 ENHANCING FOOD SAFETY ANNEx TABLE D-1 Continued FDA The FDA regulates 80% of foods, biologics, animal feeds and drugs, medical devices, and human drugs. In 2008, the FDA created the Office of Food Protection. This agency-level office is transitioning to the Deputy Commissioner for Foods. The FDA comprises nine centers and offices. Of these, the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA) house the management, investigation, scientific/laboratory, and enforcement personnel that develop, coordinate, and implement the food defense/safety/protection program. In addition, • The Office of Crisis Management coordinates emergency and crisis response activities involving FDA-regulated products or situations in which FDA-regulated products need to be utilized or deployed. It coordinates intra-agency and interagency crisis management activities, emergency preparedness and response, and security operations. • The Emergency Operations Center serves as the FDA’s focal point for all emergency response activities 7 days a week, 24 hours a day. It receives notification of an emergency through a variety of means, including from FDA Headquarters, CDC, USDA, FDA district offices, FDA centers, other federal and state agencies, consumers, and the media. Within each FDA center and each ORA region and district exists a corresponding food emergency response staff or coordinator dealing solely with food-related recalls, outbreaks, and emergency response procedures.

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 APPENDIX D ANNEx TABLE D-1 Continued CFSAN CFSAN is responsible for ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. The FDA Food Protection Plan (FPP) covers all programs within CFSAN. • Office of Food Defense, Communication and Emergency Response: With the Food and Agriculture Sector, coordinates and takes the lead on food defense policy, programs, extramural research, and outreach. • Office of Regulations, Policy, and Social Studies: lead unit for regulation development. • Office of Compliance: lead unit for investigations, enforcement coordination and policy, and compliance program direction for all CFSAN programs and activities. • Office of Regulatory Science: lead unit for intramural food defense research, FERN method development and quality assurance, and the FERN storehouse. Has microbiological, chemical, and radiological capabilities. • Joint government, academic, and industry cooperative research entities: — Joint Institute for Food Safety and Applied Nutrition (University of Maryland): focus on nutrition and produce. — National Center for Food Safety and Technology (NCFST) (Illinois Institute of Technology): focus on food processing and biosafety level (BSL)-4 pilot plant. Key FDA participant in food defense research. CVM CVM regulates the manufacture and distribution of food additives and drugs given to animals. The FDA FPP covers the Animal Feed Safety System program within CVM—a draft comprehensive, risk-based system that describes how animal feeds (individual ingredients and mixed feeds) should be manufactured and distributed to minimize risks to animals consuming the feed and people consuming food products from those animals. ORA ORA coordinates and oversees all field organizations, and is made up of (1) the Office of Regional Operations, which oversees and coordinates domestic and import investigations and laboratory and research operations and policy; (2) the Office of Enforcement, which oversees compliance and enforcement operations; (3) the Office of Administration and Budget, which oversees administrative operations, including information technology, hiring, budgeting, and planning; and (4) the Office of Criminal Investigations, which houses the lead criminal investigators for all FDA-regulated products and serves as the Federal Bureau of Investigation (FBI)/Central Intelligence Agency (CIA) law enforcement and intelligence liaison. continued

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 ENHANCING FOOD SAFETY ANNEx TABLE D-1 Continued USDA USDA regulates 20 percent of the nation’s food supply, namely meat, poultry, and egg products. It performs on-site inspection at each meat or poultry facility, monitors animal and plant disease, is involved in agriculture marketing, and develops school lunch and nutrition cooperative programs. • Food Safety and Inspection Service: responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. • Animal and Plant Health Inspection Service: Responsible for animal and plant disease prevention and control. • Agricultural Marketing Service: Provides quality assurance and training services for certain market-based food programs. • National Institute of Food and Agriculture, formerly Cooperative State Research, Education, and Extension Service. • Food and Nutrition Service: Manages programs that provide children and low-income people access to food, a healthful diet, and nutrition education. • Federal Grain Inspection Service: Helps move U.S. grain harvests into the marketplace by providing farmers, handlers, processors, exporters, and international buyers with sampling, inspection, process verification, weighing, and stowage examination services that accurately and consistently describe the quality and quantity of the commodities being bought and sold. • Agricultural Research Service: Chief scientific research agency responsible for the safety of meat, poultry, and eggs and for identifying and solving problems associated with agricultural commodities. EPA EPA’s mission is to protect human health and the environment. EPA also leads the nation’s environmental science, research, education, and assessment efforts. In the FPP, EPA is responsible for environmental and water safety, setting tolerances or safe levels for food and feed toxicants such as pesticides and industrial chemicals, which the FDA enforces. Its Office of Research and Development is the scientific research arm providing the underpinning of science and technology for the agency.

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 APPENDIX D ANNEx TABLE D-1 Continued U.S. Department of DHS has three primary missions: (1) to prevent terrorist attacks Homeland Security within the United States, (2) to reduce America’s vulnerability to (DHS) terrorism, and (3) to minimize the damage from potential attacks and natural disasters: • Office of Infrastructure Protection: establishes state homeland security offices, awards state grants to address vulnerabilities, develops and coordinates the National Infrastructure Protection Plan. • Office of Health Affairs: oversees public health emergencies. • Office of Science and Technology: establishes research agendas for Centers of Excellence. • National Center for Food Protection and Defense: with numerous partner universities, supports the Food and Agriculture Sector’s scientific and risk communication research needs. • U.S. Customs and Border Protection: conducts border surveillance and customs inspections, and serves on the FDA’s behalf to assist with or initiate imported food directives at ports of entry. • Federal Emergency Management Agency (FEMA): leads the effort to prepare the nation for all hazards and effectively manage federal response and recovery efforts following any national incident. FEMA is a key FDA FPP partner in the coordination of food protection emergency response exercises, including Food and Agriculture Sector exercises. DoD In addition to its mission to provide military forces and protect the national security, DoD houses veterinary, medical, biological, and chemical research organizations. The Defense Advanced Research Projects Agency is DoD’s central research and development office. The U.S. Army Medical Research Institute of Infectious Diseases spearheads research to develop medical solutions to protect service members from biological threats. Capabilities include BSL-3 and -4 laboratories, expertise in the generation of biological aerosols for testing candidate vaccines and therapeutics, and fully accredited animal research facilities. DoD is a key FDA FPP participant, providing the capability to conduct high-priority food defense research. U.S. Department of DoI’s Fish and Wildlife Service (FWS) serves on the Government the Interior (DoI) Coordinating Council (GCC). FWS’s mission is to work with others to conserve, protect, and enhance fish, wildlife, plants, and their habitats for the continuing benefit of the American people. continued

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 ENHANCING FOOD SAFETY ANNEx TABLE D-1 Continued U.S. Department of DoC’s mission includes fish and aquaculture operations under Commerce (DoC) the National Oceanic and Atmospheric Administration (NOAA). NOAA is a member of the GCC and represented by the National Marine Fisheries Service (NMFS). NMFS’s mission is the conservation, protection, and management of living marine resources to ensure their continuation as functioning components of marine ecosystems, afford economic opportunities, and enhance the quality of life for the American public. U.S. Department of DOJ’s mission, in part, is to enforce the law and defend the Justice (DOJ) interests of the United States according to the law. DOJ’s FBI is a key participant and counterpart in food defense intelligence gathering and a lead for tampering act enforcement and investigations. State and Tribal Government Counterparts Association of Food An organization of state food and drug officials that serves the and Drug Officials function of implementing state and federal food safety regulations and policy. Serves as the FDA’s primary counterpart in state government. Association of Public A nonprofit organization that works to safeguard the public’s Health Laboratories health by strengthening public health laboratories in the United (APHL) States and across the world. APHL advances laboratory systems and practices and promotes policies that support healthy communities. Association of State A national nonprofit organization that formulates and influences and Territorial Health sound public health policy and represents the state and territorial Officials public health agencies of the United States, the U.S. territories, and the District of Columbia. American Veterinary A nonprofit association representing veterinarians that is the Medical Association authorized voice for the profession in presenting its views to (AVMA) government, academia, agriculture, pet owners, the media, and others. Members of the National Assembly of State Chief Livestock Health Officials and American Association of Veterinary Laboratory Diagnosticians represent AVMA on the GCC. Council of State Represents the epidemiology and surveillance components of and Territorial public health. Works with CDC to improve the public’s health by Epidemiologists supporting the efforts of epidemiologists working at the state and local levels, promoting the effective use of epidemiologic data to guide public health practice and improve health.

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 APPENDIX D ANNEx TABLE D-1 Continued National Association A national organization representing local public health agencies of County and City (including city, county, metro, district, and tribal agencies), with Health Officials the goal of protecting and promoting the health of communities. (NACCHO) NACCHO supports public health in local communities by calling for strong national policy, developing useful resources and programs, seeking health equity, and supporting effective local public health practice and systems. National Association A nonprofit organization that represents the state departments of State Departments of agriculture in the development, implementation, and of Agriculture communication of sound public policy and programs that support and promote the American agricultural industry while protecting consumers and the environment. National Plant Board A nonprofit organization of regulatory agencies of each of the states and Puerto Rico. Its purpose is to foster effective and harmonized plant health programs; to act as an information clearinghouse on plant pest prevention and regulatory matters; to make recommendations to the regional boards for the promotion of efficiency, harmony, and uniformity in and among the states in the field of plant pest prevention and regulation; to collaborate and communicate effectively with public and private agencies and organizations on plant health and pest regulatory issues that affect the states; and to protect agriculture, horticulture, forestry, and the environment at the state, national, and international levels. National Works to advance, in terms of education and motivation, the Environmental Health environmental health and protection professional for the purpose Association of providing a healthful environment for all. Intertribal Agriculture Founded in 1987, IAC’s mission is to pursue and promote the Council (IAC) conservation, development, and use of agricultural resources for the betterment of Native American and Alaskan tribes. IAC works on behalf of individual Indian producers and tribal enterprises with federal government agencies and the agricultural sector. It is the most respected voice within the Indian community and government circles on agricultural policies and programs. Private-Sector Counterparts Institute of Food A nonprofit scientific society dedicated to advancing the science Technologists and technology of food and related professions in industry, academia, and government.

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