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Appendix B
Past Recommendations About the U.S. Food and Drug Administration’s Food Safety Program

TABLE B-1 Past Recommendations about U.S. Food and Drug Administration (FDA) Food Safety Program

Topic

Recommendations

Source

General Authorities

We recommended that FDA and U.S. Department of Agriculture (USDA) study their agencies’ existing statutes and identify what additional authorities they may need relating to security measures. On the basis of the results of these studies, the agencies should seek additional authority from the Congress.

GAO, 2003

Authority for Mandatory Recalls and Related Recommendations

Consumers Union (CU) has called … for Congress to grant the agency broad mandatory recall authority in light of the recent outbreak of salmonella in tomatoes.

Consumers Union, 2008a

 

The Commissioner of FDA should develop a sound methodology for district staff to verify that companies have quickly and effectively carried out recalls.

GAO, 2005a

 

To ensure that USDA and FDA have information and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would require a company to notify the responsible agency when it becomes aware that a food it has distributed is unsafe.

GAO, 2005a



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Appendix B Past Recommendations About the U.S. Food and Drug Administration’s Food Safety Program TABLE B-1 Past Recommendations about U.S. Food and Drug Administration (FDA) Food Safety Program Topic Recommendations Source General We recommended that FDA and U.S. Department GAO, 2003 Authorities of Agriculture (USDA) study their agencies’ existing statutes and identify what additional authorities they may need relating to security measures. On the basis of the results of these studies, the agencies should seek additional authority from the Congress. Authority for Consumers Union (CU) has called . . . for Consumers Mandatory Congress to grant the agency broad mandatory Union, 2008a Recalls and recall authority in light of the recent outbreak of Related salmonella in tomatoes. Recommendations The Commissioner of FDA should develop a GAO, 2005a sound methodology for district staff to verify that companies have quickly and effectively carried out recalls. To ensure that USDA and FDA have information GAO, 2005a and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would require a company to notify the responsible agency when it becomes aware that a food it has distributed is unsafe. continued 

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source To ensure that USDA and FDA have information GAO, 2005a and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would give USDA and FDA authority to issue a mandatory recall order and establish recall requirements. To ensure that companies promptly and effectively GAO, 2005a recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should revise agency guidance to recalling companies to include specific time frames for notifying their customers, removing recalled food from the marketplace, and providing the agencies with the names and locations of customers that received the food. To ensure that companies promptly and effectively GAO, 2005a recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should use agency data systems to routinely generate reports for recall program managers so that they may monitor ongoing recalls and oversee recall timeliness and effectiveness. To ensure that companies promptly and effectively GAO, 2005a recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should track in their data systems the dates that the agencies start and finish verification checks. To ensure that companies promptly and effectively GAO, 2005a recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should track in their recall data systems the dates that companies (1) start and finish notifying their customers, (2) provide the agency with the lists of customers that received the food, and (3) start and finish recovering the recalled food.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source To ensure that companies promptly and effectively GAO, 2005a recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should work jointly to determine what, if any, additional approaches are needed for alerting consumers about recalls. Authority to FDA needs the authority to enforce meaningful Consumers Impose Penalties penalties to deter behavior like the Peanut Union, 2009a Corporation of America’s. The maximum penalties for such wrongdoing should be increased from the current cap of $10,000 to $1 million. To ensure that USDA and FDA have information GAO, 2005a and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would give USDA and FDA authority to . . . impose monetary penalties or seek fines or imprisonment for failing to follow food recall requirements. Authority to CU urges Congress to overhaul the nation’s food Consumers Inspect safety laws and to mandate annual inspections of Union, 2009b food processing facilities. CU has called for the FDA to increase inspections Consumers of food processing plants. Union, 2008a Authority to To ensure that companies promptly and effectively GAO, 2005a Require Company recall foods that may cause serious illness or Records and death, the Secretary of Agriculture and the to Develop Commissioner of FDA should revise agency Traceability guidance to recalling companies to include Methods specific time frames for notifying their customers, removing recalled food from the marketplace, and providing the agencies with the names and locations of customers that received the food. To enhance FDA’s oversight of fresh produce GAO, 2008a safety, the Commissioner of FDA should seek authority from the Congress to provide FDA enhanced access to firm records during food- related emergencies. continued

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source We recommend that FDA seek statutory authority, OIG, 2009 if necessary, to strengthen existing records requirements regarding lot-specific information. We recommend that FDA consider seeking OIG, 2009 additional statutory authority to improve traceability. We recommend that FDA seek statutory authority OIG, 2009 to conduct activities to ensure that facilities are complying with its records requirements. Congress, with input from experts, should Taylor and establish traceability requirements that permit David, 2009 federal, state, and local officials to rapidly obtain from food companies reliable information on the source of commodities, ingredients, and finished products. Develop We urge FDA to move quickly to improve product Consumers Traceability traceability, and in particular to focus on the most Union, 2008b Methods problematic produce—the produce that has caused the most illnesses—first. In addition, trace-back systems that include Consumers package identifiers allowing each product to be Union, 2008a traced back to the field in which it originated are needed to further protect consumers from contaminated food. We recommend that FDA work with the food OIG, 2009 industry to develop additional guidance to strengthen traceability. Education of A more consistent and focused effort in IOM, 1991 Consumers/ determining and communicating public health Communication risks from contaminated seafood should also be developed. One-fifth of the fish and shellfish eaten in the IOM, 1991 United States is derived from recreational or subsistence fishing, and these products are not subject to health-based control; there is need to improve protection for consumers of these products by regulation of harvest and by education concerning risks associated with their consumption.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source There is a lack of understanding of the nature of IOM, 1991 seafood hazards in the food service sectors and by the consuming public and health professionals; a vigorous campaign for information dissemination and education in these matters is needed, particularly for high-risk consumers and high-risk products such as raw shellfish. The FDA should implement targeted educational IOM/NRC, programs to inform the public about the risks of 2003 consuming raw milk and raw milk products. Consolidated advice is needed that brings together IOM, 2007 different benefit and risk considerations, and is tailored to individual circumstances, to better inform consumer choices. Partnerships should be formed between federal IOM, 2007 agencies and community organizations. This effort should include targeting and involvement of intermediaries, such as physicians, and use of interactive Internet communications, which have the potential to increase the usefulness and accuracy of seafood consumption communications. Dietary advice to the general population from IOM, 2007 federal agencies should emphasize that seafood is a component of a healthy diet, particularly as it can displace other protein sources higher in saturated fat. Although advice from federal agencies should IOM, 2007 also support inclusion of seafood in the diets of pregnant females or those who may become pregnant, any consumption advice should stay within federal advisories for specific seafood types and state advisories for locally caught fish. Consumer messages should be tested to determine IOM, 2007 if there are spillover effects for segments of the population not targeted by the message. Research is needed to develop and evaluate more IOM, 2007 effective communication tools for use when conveying the health benefits and risks of seafood consumption as well as current and emerging information to the public. continued

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0 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source Among federal agencies there is a need to IOM, 2007 design and distribute better consumer advice to understand and acknowledge the context in which the information will be used by consumers. Appropriate federal agencies (National Oceanic IOM, 2007 and Atmospheric Administration [NOAA], U.S. Environmental Protection Agency [EPA], and FDA) should increase monitoring of methylmercury and persistent organic pollutants in seafood and make the resulting information readily available to the general public. Along with this information, these agencies should develop better recommendations to the public about levels of pollutants that may present a risk to specific population subgroups. To ensure that companies promptly and effectively GAO, 2005a recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should work jointly to determine what, if any, additional approaches are needed for alerting consumers about recalls. We recommend that [FDA] conduct education and OIG, 2009 outreach activities to inform the food industry about its records requirements. Establish a Single CU has also called for consolidation of the 15 Consumers Food Safety agencies that oversee our food safety system. Union, 2008a Agency To implement a science-based system, Congress IOM/NRC, should establish, by statute, a unified and central 1998 framework for managing federal food safety programs, one that is headed by a single official and which has the responsibility and control of resources for all federal food safety activities, including outbreak management, standard- setting, inspection, monitoring, surveillance, risk assessment, enforcement, research, and education. To address the growing threat of foodborne IOM, 2009 illnesses, Congress should unify the USDA’s Food Safety and Inspection Serice and the food safety actiities of FDA within U.S. Department of Health and Human Serices (HHS) and ensure provision of adequate resources for high-quality inspection, enforcement, and research.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source To develop a uniform, risk-based inspection system, GAO, 1992 we recommend that the Congress hold oversight hearings to evaluate options for revamping the federal food safety and quality system, including (1) creating a single food safety agency responsible for administering a uniform set of food safety laws, (2) creating a uniform set of food safety laws that are administered by the current federal food safety agencies, or (3) establishing a blue-ribbon panel to develop a model for inspection and food safety enforcement based on the public health risks posed by the products and processes. To provide more efficient, consistent, and effective GAO, 2004a federal oversight of the nation’s food supply, Congress may wish to consider establishing a single, independent food safety agency at the Cabinet level. If the Congress does not opt for an entire GAO, 2004a reorganization of the food safety system, it may wish to consider modifying existing laws to designate one current agency as the lead agency for all food safety inspection matters. We recommended that the Congress consider GAO, 2005b enacting comprehensive, uniform, and risk-based food safety legislation to streamline inspection and enforcement efforts, and consolidate food safety functions by establishing a single, independent food safety agency or by designating one current agency as the lead agency for all food safety inspection matters. We have recommended that the Congress consider GAO, 2005b statutory and organizational reforms, and we continue to believe that the benefits of establishing a single national system for the regulation of our food supply outweigh the costs. In making these recommendations, we fully recognize the time and effort needed to develop a reorganization plan and to transfer authorities, as necessary, under such a reorganization. continued

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source Congress should give the Secretary of HHS a Taylor and legislative mandate to lead the development of David, 2009 an integrated, national food safety system that incorporates and enhances the food safety capacity of state and local agencies. HHS and the states should declare as a matter Taylor and of policy that the establishment and enforcement David, 2009 of nationally uniform food safety standards is a common goal and joint responsibility of federal, state, and local governments, with the federal government bearing primary responsibility for establishing science-based standards for preventing foodborne illness and states and localities preserving full legal power to adopt and directly enforce federal standards and establish their own. Feed The committee recommends that the government’s NRC, 2003 risk management strategy for dioxin-like compounds (DLCs) give high-priority attention to reducing the contamination of animal forage and feed and interrupting the recycling of DLCs that result from the use of animal fat in animal feed. We recommended that . . . FDA strengthen GAO, 2003 enforcement of the feed ban and its management of inspection data. Funding CU has called for more funding for the FDA to Consumers perform yearly inspections. Union, 2008a The assessment and collection of fees from Consumers domestic and foreign food plants would also Union, 2009a supplement appropriated funds, and the fees could fund routine, up-front inspection work. Congress and the administration should require IOM/NRC, development of a comprehensive national food 1998 safety plan. Funds appropriated for food safety programs (including research and education programs) should be allocated in accordance with science-based assessments of risk and potential benefit.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source Congress should declare that the federal Taylor and government has a responsibility to support David, 2009 the capacity building needed to strengthen the performance of state and local agencies in the national food safety system and has a shared responsibility with the states to adequately fund food safety programs and capacity building, in accordance with the integration plan and benchmarks. To help carry out the federal responsibility for state and local capacity building, Congress should authorize and establish an appropriation line item for FDA to provide federal funding to the states in the form of a food safety block grant, with a specified share flowing to local agencies. In addition, Congress should establish a matching grant program to foster improvement and innovation beyond base capacity building. State and local governments should maintain stable funding streams sufficient to meet their responsibility for funding of food safety programs, in keeping with agreed criteria and benchmarks for food safety capacity and performance. continued

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source Implement On behalf of the Center for Science in the Public CSPI, 2006 Preventative Interest (CSPI) and our 900,000 members, we Approaches are submitting a petition to the FDA urging the agency to issue standards and regulations to help ensure the safe production of fresh fruits and vegetables. These regulations are clearly needed, as demonstrated by recent multi-state outbreaks in produce, including the E. coli O157:H7 outbreak from spinach that sickened over 200 people and killed at least four and the more recent Salmonella outbreak caused by tomatoes that has sickened nearly as many. Many other outbreaks have been traced to produce, and these will continue to occur until FDA adopts enforceable standards for this important sector. CSPI urges the FDA to develop mandatory regulations and auditing programs for produce growers and processors to reduce the likelihood of microbial contamination. These regulations are authorized under the Federal Food, Drug, and Cosmetic Act, section 402(a) and the Public Health Service Act, section 361. We also hope that FDA will expedite development and publication of produce regulations. The best way to minimize or prevent CSPI, 2007a contamination [in produce] is through implementation of hazard identification and process control systems. These systems should be mandated, starting with the highest risk products first—those that have been repeatedly linked to illness outbreaks. To that end, regulations should be developed that require processors and others in the fresh-cut produce supply chain to have written plans that identify hazards associated with their product and the steps, interventions, and programs taken to address those hazards. . . . [I]t is critical that these mandatory programs be developed and implemented by FDA. CU has called for . . . the agency to develop Consumers operating plans for food processing facilities that Union, 2008a insure safety, and for domestic and foreign food producers to be required to be certified as in compliance with these safety plans and with U.S. food safety standards.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source To enhance FDA’s oversight of fresh produce GAO, 2008a safety, the Commissioner of FDA should seek authority from the Congress to make explicit FDA’s authority to adopt preventive controls for high-risk foods. To enhance FDA’s oversight of fresh produce GAO, 2008a safety, the Commissioner of FDA should: 1) see that the agency update its good agricultural practices guidance for fresh produce to incorporate new knowledge about safe growing practices, 2) see that the agency update its current good manufacturing practice regulations for food to incorporate new knowledge about the food industry and safe manufacturing, processing, and holding practices. Chronic illness resulting from seafood IOM, 1991 consumption is associated primarily with environmental contamination; thus, control depends on improved understanding of the occurrence and distribution of the chemical agents involved, the exclusion of contaminated seafood from the market, and increased action to prevent additional pollution of the waters. With currently available data, it is possible to IOM, 1991 identify the source of much of the acute illness associated with seafood consumption, though the dimensions of the problems are not always known; these data, in turn, can form the basis for national control programs. The Center needs to carefully devise management CRC/SB, 1999 procedures for emergency events so that these events will not disrupt other activities. Although emergency events cannot be eliminated, management should attempt to develop systems and regulations that lessen their frequency and seriousness. continued

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0 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source CFSAN laboratory practices should conform to CRC/SB, 1999 the principles of the Association of Analytical Communities Food Laboratory Accreditation Working Group. Consideration should also be given to achieving full International Organization for Standardization 25 accreditation for CFSAN laboratories. A long-term strategic plan for dealing with critical CRC/SB, 1999 issues related to food and nutrition should be developed. This plan should be based on public health needs as revealed by the National Nutrition Monitoring Programs. The subcommittee also encourages ORA along FDA, 2008 with the entire FDA to further develop the discipline of regulatory science. The subcommittee meetings and discussions reinforced the uniqueness and importance of regulatory science as an intellectual field, and the subcommittee believes that ORA, together with the FDA Centers, must reinforce this regulatory science identity by championing risk―based programs, risk assessments, evidence―based policy and regulation, and knowledge management among other disciplines in order to successfully work in a world of greater uncertainty. These skills and activities need to be paralleled by the development of stronger analytical skills in decision―making. We understand that this discipline is still in a formative stage but encourage ORA to help lead the further maturation and use of regulatory science across FDA. Science at More complete data are needed on the distribution IOM, 2007 the FDA of contaminant levels among types of fish. —Contaminants More quantitative characterization is needed of the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source The committee recommends more research on IOM, 2007 useful biomarkers of contaminant exposures and more precise quantitative characterization of the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population, in order to reduce uncertainties associated with recommendations for acceptable ranges of intake. Develop cost-effective analytical methods and NRC, 2003 reevaluate the use of toxicity equivalents in assessing DLC exposure. To move effectively toward reducing human NRC, 2003 exposure to DLCs through food, the federal government should begin by pursuing the following strategic courses of action: (1) establish an integrated risk management strategy and action plan, (2) foster collaboration between the government and the private sector to reduce DLCs in the food supply, and (3) invest in the data required for effective risk management. Increase research efforts on the effects of dietary NRC, 2003 DLCs on fetuses and breastfeeding infants. Develop predictive modeling tools and apply NRC, 2003 them in studies to assess the effects of potential interventions on reducing DLCs in the food supply. CFSAN should carefully monitor the activities of CRC/SB, 1999 the private sector, other governmental agencies, and academia in developing rapid methods for specific pathogens, toxins and chemicals and enter into collaborative arrangements when these are feasible and effective. Management should also identify and prioritize the individual microorganism or toxin for which rapid methods are most needed and communicate these priorities to potential developers in the private sector to help avoid duplication of effort. Science at Increase research efforts aimed at removing DLCs NRC, 2003 the FDA from animal forage and feed. —Contaminants in Feed continued

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source Science at the The committee recommends that CVM continue NRC, 1999 FDA—Food procedural reform to expedite the drug approval Animals review process and broaden its perspective on efficacy and risk assessment to encompass review of data on products already approved and used elsewhere in the world. The committee recommends that, to improve NRC, 1999 drug availability [for food animals], worldwide harmonization of requirements for drug development and review be considered and further enhanced among the federal agencies that are responsible for ensuring the safety of the food supply. The committee recommends that CVM base NRC, 1999 drug use guidelines on maximal safe dosage regimens for specific food animals, consider greater emphasis on the pharmacokinetics of drug elimination from tissues that are consumed in large quantity, and set drug withdrawal times accordingly. The committee recommends establishment NRC, 1999 of integrated national databases to support a rational, visible, science-driven decision-making process and policy development for regulatory approval and use of antibiotics in food animals, which would ensure the effectiveness of these drugs and the safety of foods of animal origin. The committee recommends that further NRC, 1999 development and use of antibiotics in both human medicine and food-animal practices have oversight by an interdisciplinary panel of experts composed of representatives of the veterinary and animal health industry, the human medicine community, consumer advocacy, the animal production industry, research, epidemiology, and the regulatory agencies. The committee recommends increased funding for NRC, 1999 basic research that explores and discovers new or novel antibiotics and mechanisms of their action, including the development of more rapid and wide-screen diagnostics to improve the tracking of emerging antibiotic resistance and zoonotic disease.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source Science at the New tools apart from traditional safety assessments IOM, 2007 FDA—Seafood should be developed, such as consumer-based benefit-risk analyses. A better way is needed to characterize the risks combined with benefit analysis. A consumer-directed decision path needs to be IOM, 2007 properly designed, tested, and evaluated. The resulting product must undergo methodological review and update on a continuing basis. Responsible agencies will need to work with specialists in risk communication and evaluation, and tailor advice to specific groups as appropriate. Research is needed on systematic surveillance IOM, 2007 studies of targeted subpopulations. Sufficiently large analytic samples of the most IOM, 2007 common seafood types need to be obtained and examined. Additional data is needed to assess benefits and IOM, 2007 risks associated with seafood consumption within the same population or population subgroup. Future epidemiological studies should assess intake IOM, 2007 of specific species of seafood and/or biomarkers, in order to differentiate the health effects of eicosapentaenoic acid/docosahexaenoic acid from the health effects of contaminants such as methylmercury. More complete data are needed on the distribution IOM, 2007 of contaminant levels among types of fish. More quantitative characterization is needed of IOM, 2007 the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population. continued

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source The committee recommends more research on IOM, 2007 useful biomarkers of contaminant exposures and more precise quantitative characterization of the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population, in order to reduce uncertainties associated with recommendations for acceptable ranges of intake. Research is needed to develop and evaluate more IOM, 2007 effective communication tools for use when conveying the health benefits and risks of seafood consumption as well as current and emerging information to the public. Among federal agencies there is a need to IOM, 2007 design and distribute better consumer advice to understand and acknowledge the context in which the information will be used by consumers. Sharing The FDA should strengthen its collaboration FDA, 2007 Information/ across Centers and with other government Interagency agencies. It should appoint a Director of External Collaboration Collaborations to administer a competitive external grants program. To more efficiently and effectively monitor the GAO, 2004b safety of imported seafood, the Secretary of HHS should direct the Commissioner of FDA to work toward developing a memorandum of understanding with NOAA that leverages NOAA’s Seafood Inspection Program’s resources. The memorandum of understanding should address mutually agreeable protocols and training programs that are necessary to begin using NOAA employees to provide various services. Those services could include inspections of foreign firms, importer inspections, port-of-entry examinations and sample collections, and laboratory analyses.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source The Secretary of Agriculture and the GAO, 2005c Commissioner of FDA should work together to ensure the implementation of the interagency agreement that calls for, among other things, sharing inspection- and enforcement-related information at food-processing facilities that are under the jurisdiction of both agencies. To foster transparency and accountability, the GAO, 2008a Commissioner of FDA should provide specific information to the Congress and to the public on the strategies and resources for implementing the Food Protection Plan. To enhance FDA’s oversight of fresh produce IOM, 1991 safety, the Commissioner of FDA should see that the agency identify approaches for obtaining testing and other information from industry members to inform its research agenda. The development of an interagency structure with IOM, 1991 a single focus on seafood safety could contribute significantly toward increasing communication within the federal regulatory system, but the responsibility for primary control should be with the state. A more concise, comprehensive, and generally IOM, 1991 available single source for all FDA guidelines relating to seafood safety should be developed and updated on a regular basis. This information should be disseminated to industry and integrated into state regulatory processes through more routine and uniform training programs. Congress should provide the agency responsible IOM/NRC, for food safety at the federal level with the tools 1998 necessary to integrate and unify the efforts of authorities at the state and local levels to enhance food safety. continued

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source Partnerships should be formed between federal IOM, 2007 agencies and community organizations. This effort should include targeting and involvement of intermediaries, such as physicians, and use of interactive Internet communications, which have the potential to increase the usefulness and accuracy of seafood consumption communications. Effort should be made to improve coordination IOM, 2007 of federal guidance with that provided through partnerships at the state and local level. The CRC endorses research collaboration CRC/SB, 1999 among various groups with interests in food safety practices and regulations, provided these collaborations have been determined to be the most effective and efficient approaches available. Factors that should be considered when contemplating collaboration include availability of appropriate personnel, equipment, and facilities; cost effectiveness of various alternative options, and likely long-term effectiveness of the partnership. Research should not duplicate that which is being CRC/SB, 1999 conducted elsewhere, and partners should be sought whenever appropriate and possible. For example, the CRC noted that research on soy products and their effects is currently underway at Iowa State University, University of Illinois, Loma Linda University and other institutions. Thus, work at these institutions should not be duplicated by CFSAN. By the nature of its mission ORA’s work is FDA, 2008 increasingly more reliant on partners and collaborations, including various stakeholders within and outside of the FDA. The extensive collaboration among federal, state inspection and increasingly foreign regulatory agencies is already impressive. The subcommittee encourages ORA to continue expend the time, energy, and resources necessary to build and secure greater collaboration locally, statewide, across other federal agencies outside FDA and globally.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source Congress should establish and fund an inter- Taylor and governmental Food Safety Leadership Council David, 2009 to foster federal-state-local collaboration in the design and implementation of an integrated national food safety system. The Secretary, in consultation with the Food Taylor and Safety Leadership Council and in collaboration David, 2009 with appropriate professional organizations, should conduct a survey of the current food safety capacities of state and local agencies—including staffing and skill levels, laboratory capacities, information systems, legal authorities, and organizational arrangements—and, on the basis of the survey, identify and prioritize capacity building and other state and local needs that must be met to fulfill their roles in the national food safety system. Congress should direct HHS to develop, based on the capacity survey and consultations with the Food Safety Leadership Council, a 5-year plan for better integrating federal, state, and local food safety efforts and improving state and local capacity for that purpose. The integration plan should be based on mutually agreed criteria and benchmarks for such matters as timeliness of outbreak investigations, frequency of retail inspection, food safety staffing and skill levels, laboratory capacity, and information systems. State and local governments should better integrate Taylor and their own surveillance, outbreak response, and David, 2009 food safety regulatory and inspection activities, and each state should establish a focal point for better linking and integrating the state’s food safety activities with the national system. State and local governments should collaborate on the development and widespread adoption of a model state and local food safety law that addresses all aspects of state and local roles in food safety, modernizes food safety regulatory laws to adopt a more preventive and risk-based approach, clarifies the roles of state and local agencies in a more integrated system, and legally empowers state and local agencies to work more collaboratively among themselves and with the federal government. continued

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 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source HHS, working through CDC and FDA and in Taylor and collaboration with states and localities, should David, 2009 establish a network of regional, federally-funded foodborne outbreak response centers to ensure an integrated “systems” approach to outbreak response and follow-up investigations. The centers would be staffed fulltime with a multi-disciplinary team of federal, state, and local epidemiologists, environmental health experts, regulatory officials, and food safety communicators (all federally funded) for purposes of: (1) supporting state and local agencies in their day-to-day foodborne illness surveillance and response activities; (2) improving the thoroughness and timeliness of outbreak detection, response, and follow-up investigation to inform future prevention; and (3) establishing the relationships, expertise, continuity, and surge capacity needed to ensure well-coordinated and effective response to major outbreaks. HHS, in consultation with the Food Safety Taylor and Leadership Council and working with states and David, 2009 localities, should establish protocols for managing multi-state outbreaks, including clear definition of federal, state, and local roles; mechanisms for collaboration; and criteria for triggering federal- level management of outbreaks. Training The Secretary of Agriculture and the GAO, 2005c Commissioner of FDA should work together to examine the feasibility of establishing a joint training program for food inspectors. All personnel should be fully cognizant of the CRC/SB, 1999 goals of their program. Each project should undergo a formal review annually and be evaluated for progress, current priority status, and likelihood that continuation will lead to success. We also recommended that both agencies provide GAO, 2003 training for all field personnel to enhance their awareness and ability to discuss security measures with plant personnel.

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 APPENDIX B TABLE B-1 Continued Topic Recommendations Source HHS, in collaboration with the Food Safety Taylor and Leadership Council, should establish a Food Safety David, 2009 Leadership and Training Institute focused on building among food safety professionals at all levels a common vision for the nation’s food safety system and the leadership skills, network of relationships, and trust needed for an integrated system to succeed. REFERENCES Consumers Union. 2008a. Increased Inspections Needed for Produce, Processing Plants to Protect Consumers from Unsafe Food. http://www.consumersunion.org/pub/core_food_ safety/005732.html (accessed September 9, 2009). Consumers Union. 2008b. CU Testimony on Product Tracing for Fresh Produce. http://www. consumersunion.org/pub/core_food_safety/006294.html (accessed September 9, 2009). Consumers Union. 2009a. CU letter to Senator Durbin Regarding FDA Food Safety Modernization Act. http://www.consumersunion.org/pub/core_food_safety/009641.html (accessed September 9, 2009). Consumers Union. 2009b. Consumers Union: House Hearing on Industry Role in Salmonella Outbreak Underscores Need for Comprehensie, Annual Food Inspections; Companies Cannot Rely on Paid­for Third­Party Safety Reiews. http://www.consumersunion.org/ pub/core_food_safety/009779.html (accessed September 9, 2009). CRC/SB (Center for Food Safety and Applied Nutrition Review Committee/Science Board). 1999. Reiew of Research Programs. Center for Food Safety and Applied Nutrition. U.S. Food and Drug Administration. April 13−16, 1999. http://fda.gov/ohrms/dockets/AC/06/ briefing/2006-4211b_02_CFSAN1999Review.pdf (accessed August 9, 2010). CSPI (Center for Science in the Public Interest). 2003. Comments on Interim Final Rule to Implement Prior Notice of Imported Food Under the Public Health Security and Bio­ terrorism Preparedness and Response Act of 00. http://cspinet.org/new/pdf/fda.biot. priornot.finalrule.pdf (accessed September 9, 2009). CSPI. 2006. CSPI Petitions FDA to Regulate Manure, Water Sanitation on Farms. http:// cspinet.org/new/pdf/fda_produce_petition.pdf (accessed September 9, 2009). CSPI. 2007a. Comments on Handling Regulations for Leafy Greens Under the Agricultural Marketing Agreement Act of . http://cspinet.org/new/pdf/ams_produce_comments. pdf (accessed September 9, 2009). CSPI. 2007b. Letter to Commissioner on Eschenbach Regarding the Pet Food Recall and Ban on Chinese Grain Imports. http://cspinet.org/new/pdf/fda_pet_food_letter_final.pdf (accessed September 9, 2009). CSPI. 2008. Comments on Third­Party Certification Programs for Foods and Feeds. http:// cspinet.org/new/pdf/fda_3rd_part_cert_comment.pdf (accessed September 9, 2009). FDA (U.S. Food and Drug Administration). 2007. FDA Science and Mission at Risk. Report of the Subcommittee on Science and Technology. Prepared for FDA Science Board. FDA. 2008. Reiew of the FDA Office of Regulatory Affairs (ORA): Report by the ORA Subcommittee to the FDA Science Board. http://www.fda.gov/ohrms/dockets/AC/08/ briefing/2008-4365b1_02_02_subcommitteereportonORA.pdf (accessed August 9, 2010).

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