Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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Appendix D: The U.S. Food and Drug Administration's Food Defense Program
Appendix D: The U.S. Food and Drug Administration's Food Defense Program
Pages 403-450
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From page 403... ...
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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From page 404... ...
The FDA focused its efforts on targeted industry guidance and outreach, inspections, research (e.g., methods development and validation, characteristics and behavior of agents in foods, pathogenicity/toxicity in foods) , and mitigation strategies to reduce potential risks in the food supply.
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From page 405... ...
Equally important was training the FDA's own investigators and field scientists in this new threat -- intentional contamination of the food supply. 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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Environmental Protection Agency (EPA) were embarking on different paths, many using established food safety risk assessment methodologies, to protect the food supply.
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From page 407... ...
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.
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From page 408... ...
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)
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From page 409... ...
. Regular conference calls and quarterly meetings of the GCC and SCC addressed organizational issues, communication efforts, emergency operations, training and planning, identification of annual priorities, and participation in such activities as emergency response exercises, the development of risk communication templates, and a Strategic Partnership Program Agroterrorism (SPPA)
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From page 410... ...
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)
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From page 411... ...
The SPPA initiative 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 communication among industry, government, and law enforcement stakeholders concerned with the safety and security of the food supply.
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From page 412... ...
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.
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From page 413... ...
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.
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From page 414... ...
It has been noted that the Food and Agriculture Sector's assets, usually a system and not a single facility, do not fit well within the assessment criteria of DHS's Infrastructure Protection model assessment. Therefore, DHS has not funded the protection of the Food and Agriculture Sector's self-identified critical infrastructure/key resources to date.
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From page 415... ...
While not mentioned in interviews, another potential factor in the future role and continued existence of a robust and active Food and Agriculture Sector is the current proposed food safety and defense legislation, HR27497 (see Annex D-1) , and similar Senate bills now being considered by Congress.
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From page 416... ...
The PN Center and CBP's targeting center staff, working together, have improved coverage not just of suspect foods, but of all imported foods. Upon review and analysis of PN data and using an algorithm to target suspect shipments, the PN Center assigns activities for FDA and/or CBP investigators around the country to inspect, seize, or sample shipments for 8 Public Health Security and Bioterrorism Preparedness and Response Act of 00, Public Law 107-188, 107th Cong., 2nd sess.
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From page 417... ...
The FDA lacks sufficient staff to inspect all foreign food facilities and thus must preferentially target high-risk facilities for inspection to use its limited resources wisely. Record Keeping Record keeping requires each domestic food manufacturer, processor, holder, or distributor to retain records of incoming ingredients and supplies and of outgoing products.
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From page 418... ...
Administrative Detention Administrative detention gives the FDA domestic embargo authority whereby suspect or contaminated food in commercial channels can be stopped until judicial action is taken to seize and/or destroy it. However, this authority again requires that the FDA meet the SAHCDHA standard before holding food in domestic commerce.
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From page 419... ...
As FDA inspectors became more experienced with food defense measures, moreover, they routinely offered recommendations to, or shared educational materials with, industry facility management as part of their regular food safety inspections. The FDA, along with USDA/ FSIS, has developed training materials, web-based tutorials, and awareness training modules for use by government and industry (FDA, 2009f)
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From page 420... ...
-4 laboratory capability; • ORA's field laboratories and research centers, also with BSL-4 capability; • the National Center for Food Safety and Technology, one of the FDA's cooperative research centers, focused on food processing and technology; • NCFPD, a DHS Office of Science and Technology Center of Excel lence, consisting of a consortium of universities; • USDA's Agricultural Research Service (ARS) ; • USDA's Cooperative State Research, Education and Extension Ser vice, a research grant agency; • EPA's Office of Research and Development; • DoD's Defense Advanced Research Projects Agency and the United States Army Medical Research Institute of Infectious Diseases; and • other academic partners through competitive grants from federal sources.
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From page 421... ...
• Yersinia pseudotuberculosis, Salmonella enteritidis, and Escherichia coli O157:H7 can survive in flour and infant formula beyond 180 days. Survival in flour was best under refrigerated conditions.
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Research on these agents posed a safety risk requiring special clothing, air/hood systems, and storage and disposal procedures. The FDA established new procedures and conducted training and performance testing to ensure that its laboratories, and the broader Food Emergency Response Network (FERN)
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From page 423... ...
An episode in 2005 tested the FDA's risk assessment and research capacity and demonstrated that the FDA, the milk industry, and the states were prepared to act quickly and effectively. All gained a better appreciation of the time and effort required to address potential food defense threats and the essential role of the new food defense capabilities as well as existing food safety systems.
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From page 424... ...
OCM would in turn trigger its emergency response procedures, including notifying all relevant federal, state, and industry counterparts. FOOD DEFENSE WITHIN THE FDA'S FPP Prior to 2007, food defense and food safety program resources were usually separate in budgeting, program planning, and program goals and objectives.
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From page 425... ...
• The FDA proposes establishing a new strategic framework for an integrated national food safety system. To achieve this objective, the FDA must build new and expand existing programs and rela tionships with its federal, state, local, tribal, and territorial regu latory partners.
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From page 426... ...
Although some new staff were hired and trained over time, it was important for the FDA to retain its food safety expertise. For the near term, it redirected these resources to food defense research, training, education, risk communication, and compliance issues and problems.
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From page 427... ...
The FDA, along with its federal food safety counterparts, had to forge a new working relationship with DHS to achieve its food defense goals and objectives. Through DHS's mission and scope of authorities, coupled with a series of HSPDs, the federal government, in cooperation with state, local, and industry counterparts, pursued an expanded effort to protect the nation's food supply from intentional attacks.
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From page 428... ...
The agency has applied these funds primarily by redirecting existing scientific, program, and technical personnel to the food defense program. In so doing, the FDA has preserved its core food safety capacity and expertise while focusing its priorities on food defense issues.
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Congressional bills currently being discussed contain authorities to identify domestic and foreign food facilities through annual/biannual registration, to trace contaminated food products through records and impose fines when failures occur, to require food safety and defense prevention plans at each food facility or allow the FDA to impose fines for failures to maintain such plans, and to issue mandatory recall/stoppage of contaminated foods in commercial channels. With these additional legal authorities and associated funding, the FDA should have sufficient means to meet its ambitious goals for improving the overall safety of the nation's food supply.
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Prevents food safety problems before they occur: Requires foreign • and domestic food facilities to have safety plans in place to identify and mitigate hazards. Safety plans and food facility records would be subject to review by FDA inspectors and third-party certifiers.
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Strengthens penalties imposed on food facilities that fail to comply with safety requirements. Advances the science of food safety: Directs the Secretary to • enhance foodborne illness surveillance systems so as to improve the collection, analysis, reporting, and usefulness of data on such illnesses.
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From page 432... ...
ANNEx D-2 AUTHORITIES Under the FDCA,12 the FDA regulates 80 percent of the nation's food supply, including all foods and animal feeds except for meat, poultry, and egg products, which are regulated by USDA. The FDA may take enforcement action when a food or feed is found to be adulterated.
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. 29 Public Health Security and Bioterrorism Preparedness and Response Act of 00, Public Law 107-188, 107th Cong., 2nd sess.
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In addition, roughly 600,000 restaurants and institutional food service providers, an estimated 235,000 grocery stores, and other food outlets are regulated by state and local authorities that receive guidance and other technical assistance from the FDA. The Food and Agriculture Sector is dependent upon the Water Sec
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From page 435... ...
PRIORITY PROGRAMS The SPPA Initiative To assist in protecting the nation's food supply, the FBI, DHS, USDA, and HHS/FDA developed a joint assessment program -- the SPPA initiative. This initiative included a series of assessments of the Food and Agriculture Sector in collaboration with private industry and state volunteers.
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. FASCAT The Food and Agriculture Sector GCC has partnered with one of DHS's Centers of Excellence, the NCFPD, to develop an assessment tool to assist states in determining and documenting the most critical elements and systems/subsystems of food and agriculture infrastructure at the state level.
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From page 437... ...
Background Beginning in 2005, the FDA required certain food facilities to maintain records identifying the sources, recipients, and transporters of food products. The purpose of these records is to allow the FDA to trace an article of food through each stage of the food supply chain -- from a retail shelf back to a farm -- if the FDA has a reasonable belief that a food product is adulterated and presents a serious health threat.
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For the traceability exercise, we purchased 40 food products from different retail stores and attempted to trace them through each stage of the food supply chain back to the farm(s) or the border.
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Several factors prevented us from tracing the specific products through the food supply chain. Several factors limited our ability to trace the specific food products through each stage of the food supply chain.
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The FDA envisions establishing a new strategic framework for an integrated 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 regulatory partners, specifically its federal, state, local, tribal, and territorial partners.
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From page 441... ...
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.
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. FSIS (Food Safety and Inspection Service)
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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)
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Of these, the Center for Food Safety and Applied Nutrition (CFSAN) , the Center for Veterinary Medicine (CVM)
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• Joint government, academic, and industry cooperative research entities: -- Joint Institute for Food Safety and Applied Nutrition (University of Maryland) : focus on nutrition and produce.
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• 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.
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From page 447... ...
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.
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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.
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From page 449... ...
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.
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