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7 Integrating Federal, State, and Local Government Food Safety Programs T he regulations and programs of state and local (including tribal and territorial) governments have been a strong component of the U.S. food safety system for the past century. Their key regulatory pro- grams in food safety address food and public health surveillance as well as food inspection and analysis. The U.S. Food and Drug Administration (FDA) is responsible for more than 156,008 domestic food facilities (FDA, 2010), more than 1 mil- lion food establishments1 (including restaurants and retail establishments), and more than 2 million farms (Mavity, 2009). Given the size, complex- ity, and growth of the food industry in the United States, both domestic and imported, it would be unrealistic to expect the FDA to have enough resources to provide adequate surveillance and inspection of the entire U.S. food supply and to encompass all areas of policy currently overseen by state and local agencies. In fact, the FDA has repeatedly been criticized by orga- nizations and individuals both inside and outside government, including the U.S. Government Accountability Office (GAO) and the Congressional Research Service, for the lack of adequate surveillance and inspection of the U.S. food supply (GAO, 2004a,b,c; 2005a,b, 2008a,b,c,d, 2009a,b; CRS, 2007; Hutt, 2007, 2008; Becker, 2008, 2009). In this context, it is clear that the FDA could better leverage its food safety knowledge through improved access to, and utilization of, data from state and local authorities (e.g., data from food safety inspections, disease outbreak and product safety investigations, enforcement actions). 1 Personal communication, Chad Nelson, FDA, October 13, 2009. 0

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0 ENHANCING FOOD SAFETY The idea of integrating federal, state, and local agencies into a national food safety system has been espoused in reports of the Association of Food and Drug Officials (AFDO) (Hile, 1984; AFDO, 2001, 2009a,b), in the Institute of Medicine (IOM)/National Research Council (NRC) report Ensuring Safe Food: From Production to Consumption (IOM/ NRC, 1998), by consumer representatives (DeWaal, 2003), and more recently in the report Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System (Taylor and David, 2009). The committee understands an integrated system to be one that (1) minimizes duplication of food safety activities (e.g., inspection, education, data collection) by leveraging efforts at the state and local levels; (2) follows a common risk-based approach to prioritize activities at all levels of govern- ment; (3) meets a minimum set of standards at all levels of government in various areas (e.g., collection, utilization, and reporting of data; equivalency of laws and regulations and their implementation; inspection procedures and training; foodborne illness investigations); and (4) accesses and utilizes data and information collected at the state and local levels. For the purposes of this report, the terms “collaboration” and “cooperation” are used inter- changeably to mean “interaction between [entities] that is largely beneficial to all those participating.”2 This chapter presents the committee’s rationale for supporting an inte- grated food safety system and describes the steps necessary to facilitate such integration. It also delineates the role and responsibilities of the FDA and the actions necessary to achieve integration and cooperation with state and local food safety programs. Other chapters offer recommendations whose implementation would facilitate the integration proposed in this chapter. For example, the chapters on internal organizational changes (Chapter 11), increased the efficiency of inspections (Chapter 8), and the adoption of a risk-based approach to food safety (Chapter 3) provide the basis for the harmonization and integration recommended herein. For the majority of the committee’s recommendations on this subject, the literature base is sparse. Most of the evidence supporting these recommendations was derived from information received from the FDA at the request of the committee, conver- sations with federal government employees, individual committee members’ regulatory and other experiences, and past reports addressing this topic. 2 Definition found at http://www.merriam-webster.com/.

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0 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS PREVIOUS RECOMMENDATIONS FOR THE INTEGRATION OF FOOD SAFETY PROGRAMS Many individuals and organizations are calling, once again, for reform of the nation’s food safety system across all levels of government (local, state, and federal) and all phases of the food production continuum, including both domestic and international products. Multiple congressional and regu- latory initiatives are aimed at making proposed reforms a reality (Hogan & Hartson, LLP, 2009). This section reviews the recommendations for integra- tion offered by the IOM/NRC (1998) and Taylor and David (2009), who expanded upon previous recommendations by providing a road map for an integrated food safety system. The committee supports these recommenda- tions, which are presented in greater detail in Appendix B. Recommendations of the IOM/NRC The IOM/NRC (1998) report Ensuring Safe Food: From Production to Consumption calls for an integrated, risk-based food safety system and modernization of federal food safety laws (IOM/NRC, 1998). The report further recommends that Congress provide the agencies responsible for food safety with the tools necessary to integrate and unify the efforts of authorities at the state and local levels to enhance food safety. While the report addresses the federal role in the food safety system, it states that “the roles of state and local government entities are equally critical” (pp. 14, 97, 99) and cites the need to ensure nationwide adherence to minimum standards. In addressing the need for improved integration of federal, state, and local food safety programs, the report notes the lack of adequate integration among the activities of the main federal agencies involved in implementing the 35 primary statutes that regulate food safety and the activities of state and local agencies, as well as the need for reorganization (IOM/NRC, 1998). These findings remain true today, and the recommendations offered in that report, which were directed to Congress, have not been implemented. After the 1998 IOM/NRC report was issued, and in response to the Clinton Administration’s Food Safety Initiative, the FDA cooperated with other federal, state, and local agencies to improve partnerships by hosting a 50-state meeting in 1998, whose purpose was to examine the long-held vision of an integrated national food safety system (HHS, 1998). That meeting included a series of workshops that continued into 2001 with the purpose of identifying key areas in need of integration. These areas included laboratory operations, information sharing, outbreak investigation, the establishment of national uniform criteria for food safety programs, and the clarification of roles and responsibilities (NFSSP, 2001). One positive out-

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0 ENHANCING FOOD SAFETY come was the implementation of the FDA’s Electronic Laboratory Exchange Network (eLEXNET), discussed later in the chapter. In 2008, the FDA convened a similar 50-state meeting titled the Gateway to Food Protection. Its purpose was to reflect on progress and accomplishments made since the initial 1998 meeting (FDA, 2008) and to identify ways of strengthening the food safety system in a manner consistent with the FDA’s 2007 Food Protection Plan (FPP) (FDA, 2007a). Both the 1998 and 2008 meetings were chaired by then Deputy Director of the Cen- ter for Food Safety and Applied Nutrition Janice Oliver, who stated: “We recognized that the states, the local governments, we all needed each other. Then, as now, we weren’t trying to re-invent the system but to improve the system we had, and to work better together doing it” (FDA, 2008, p. 6). The 1998 meeting led to a more cooperative relationship between state and federal agencies, which contributed significantly to the implementation of the Bioterrorism Act of 2002, in which the states had a key partnership role (see also Appendix D). On the negative side, the security threats of that decade caused agencies to rethink openness and sharing of sensitive information related to food safety (Strickland, 2005). Recommendations of Taylor and David (2009) The Taylor and David (2009) report Stronger Partnerships for Safer Food reiterates the vision of an integrated food safety system. The report was funded by the Robert Wood Johnson Foundation and spearheaded by the School of Public Health and Health Services at the George Washington University in collaboration with AFDO, the Association of State and Terri- torial Health Officials (ASTHO), and the National Association of County and City Health Officials (Taylor and David, 2009). During workshops leading up to the report, Michael Taylor, one of its authors, was quoted as saying, “State and local agencies occupy the critical frontline in the nation’s food safety system. Food safety reform at the federal level will be incom- plete and insufficient unless it strengthens state and local roles and builds true partnership across all levels of government.” Dr. Paul Jarris, executive director of ASTHO, continued, “Protecting Americans and assuring them that the food they eat is safe is a fundamental responsibility of state and local health departments.” Joseph Corby, executive director of AFDO and former state food regulatory official, further supported integration by say- ing, “Integrating the food safety efforts of federal, state, and local agencies is key to dramatically improve this country’s food safety system. This report provides a clear plan for accomplishing this integration.”3 The report begins by recognizing progress in integration: “Since the 3 Personal communication, Joseph Corby, executive director of AFDO, August 25, 2009.

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0 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS 1990s federal, state, and local agencies have expanded their collaboration in some areas—such as illness surveillance and inspection—and there exists today among food safety officials at all levels a widely shared vision of an integrated national food safety system that operates as a full partnership among federal, state, and local agencies” (Taylor and David, 2009, p. 1). The report then presents 19 strategic recommendations for strengthening the system, which are detailed in Appendix B. A common theme is the dispersal of functions across many federal, state, and local agencies and recognition that while the states’ systems are a valuable asset, challenges are associated with such a decentralized system. The need for strengthened collaboration, partnerships, standardization, and oversight is clearly articu- lated. The committee fully supports those 19 recommendations. While the FDA has recently made progress toward implementing the recommendations in the Taylor and David report, the majority of the issues raised remain unresolved. Those recommendations on which significant progress has been made include the following: • “Recommendation for Congress to establish and fund an inter- governmental Food Safety Leadership Council (FSLC) through which the federal government would collaborate with state and local governments to design and implement an integrated national food safety system including the development of a five-year inte- gration and capacity-building plan to meet high priority state and local capacity needs” (Taylor and David, 2009, p. 2). The FDA is already moving to implement a new plan, the Integrated Food Safety System (IFSS), that focuses on instituting standards and mechanisms for data sharing, with oversight by a new FDA orga- nizational structure (Steering Committee) (Solomon, 2009a). The White House Food Safety Working Group (FSWG) not only should be informed about progress on this plan but, with the enhance- ments outlined in Chapter 11, also could function as the proposed FSLC and provide leadership to the FDA Steering Committee to ensure integration of state programs in the next 5 years. • “State and local governments should collaborate on the develop- ment and widespread adoption of a model state and local food safety law to parallel pending reforms at the federal level, clarify the role of state and local agencies in a more integrated system, and legally empower state and local agencies to work more collabora- tively among themselves and with the federal government” (Taylor and David, 2009, pp. 17, 59). In 1984, the states, working through AFDO, crafted a Model Food, Drug, and Cosmetic Act for adop- tion by state legislatures, which continues to be updated for state adoption (Burditt, 1995). At the request of the Tomato Forum in

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0 ENHANCING FOOD SAFETY 2006, AFDO began working with federal agencies and industry to draft the recently completed Model Code for Produce Safety for adoption by the states. States cooperate to provide positions and recommendations to the FDA on regulatory changes in food safety through their official representation in the Conference for Food Protection. The shellfish industry (through the Interstate Shellfish Sanitation Conference) and dairy producers (through the National Conference on Interstate Milk Shipments) have also embraced the conference mechanism as a means to foster collaborative partner- ships between state and federal agencies and provide model food safety programs for widespread adoption. Although the level of success of these conferences varies, these conferences have provided a mechanism of past cooperation with the FDA. • The U.S. Department of Health and Human Services (HHS), “in collaboration with the [FSLC], should establish a Food Safety 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 relation- ships, and trust needed for an integrated system to succeed” (Taylor and David, 2009, p. 45). Although this recommendation was not meant to duplicate existing efforts in technical training, it called for greater coordination and support in developing training curricula, including those for inspectors. In 2009 AFDO received a $2 mil- lion grant from the Kellogg Foundation to create a food protection training institute. Established in collaboration with the Interna- tional Food Protection Training Institute (IFPTI) in Michigan, it began offering a course in managing retail food safety in 2009. Congress provided a $1 million appropriation to establish a per- manent home for this new institute in 2009 “to ensure that food safety inspectors would have the training and skills necessary to do their jobs and to keep consumers safe” (Upton, 2009). Many other organizations and governments offer food safety training. For example, the states help ensure that personnel are trained to implement seafood Hazard Analysis and Critical Control Points (HACCP) through the Seafood HACCP Alliance. See Chapter 9 for further discussion of training. • “Congress should establish traceability requirements that permit federal, state, and local officials to rapidly obtain from food compa- nies reliable information on the source of commodities, ingredients, and finished products” (Taylor and David, 2009, p. 17). Although some traceability systems are in place and others are in develop- ment for specific commodities, such as produce, concerns remain regarding many aspects of traceability. Most notable among these

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 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS concerns are the ability to link internal (within a company) and external traceability and the identification of key elements needed for an effective traceability system (IFT, 2009). Collaborative efforts between the FDA and the U.S. Department of Agriculture (USDA) have recently been initiated to advance widespread implementation of traceability, but many barriers remain. For example, in 2009 the FDA and USDA hosted a public meeting (HHS/FDA, 2009) to gather information on and engage stakeholders in the development of efficient and feasible food and feed tracing systems. The FDA acknowledged that with the current system, tracing the source of foodborne illness outbreaks at each step of the chain can be time- consuming and inefficient; hence a mandate to maintain records is critical (HHS/FDA, 2009). Many efforts are currently being devoted to developing traceability systems through collaboration among the FDA, academic institutions, and industry. An example of industry efforts is the Produce Traceability Initiative, sponsored by the United Fresh Produce Association, the Produce Marketing Association, and the Canadian Produce Marketing Association, which is working to develop a standardized electronic traceability system for all fresh produce (PTI, 2008). STATES CALL FOR INTEGRATION The states have historically called for greater partnership and integra- tion with the federal food safety program and have sought to counter a lack of trust and acceptance. Many factors have contributed to this situation, such as the fact that state and local food regulatory programs are highly variable in quality, expertise, and resources. In addition, there is a pervasive federal view that only federal data or inspections will suffice for regulatory purposes. Further, there is a lack of willingness on the part of the states to surrender certain controls to meet what they believe to be bureaucratic and inflexible federal requirements. The states have formed informal yet strong relationships through such joint associations as AFDO (established in 1896) and ASTHO (established in 1879), in which food regulatory officials from all states are represented. AFDO intensified its pressure for federal recognition of state programs in 1984 during an annual conference with the FDA, with a focus on creative partnerships between state and federal officials. Then associate commis- sioner for regulatory affairs Paul Hile spoke of the need to gain the FDA’s acceptance of state inspectional and analytical findings beyond the limited case of contamination by the pesticide ethylene dibromide (Hile, 1984). At the time, the FDA had a limited pilot program with the Association of American Feed Control Officials that involved 10 to 12 states participat-

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 ENHANCING FOOD SAFETY ing in a cooperative agreement on data sharing. Hile viewed the necessary components of federal–state cooperation to be based on the willingness of the parties to share knowledge, avoid unnecessary confrontations, fine-tune respective roles, foster understanding, build credibility, and establish an atmosphere of mutual trust. In the October 1984 AFDO Quarterly Bulle­ tin, Hile went on to state: “These are the building stones on which effective partnerships of any kind are built. They are the attitudes that must prevail in our organizations if we are to achieve the efficiencies these times of fiscal restraint demand of us” (Hile, 1984). ADEqUACY OF STATE AND LOCAL GOVERNMENT FOOD SAFETY REGULATORY PROGRAMS Trust in the adequacy of state and local programs remains an issue. In a statement to the committee, Dr. Steven Solomon, Deputy Associate Com- missioner for Compliance Policy, Office of Regulatory Affairs (ORA), FDA, said: “As we move with further integrating with the states [on the recom- mendations included in the Taylor report] we really need to build up an enhanced FDA infrastructure to meet the demands and maintain adequate oversight to make sure there is credibility in these programs” (Solomon, 2009a). Solomon further identified two major barriers to integration: (1) sustainability of resources and information and (2) difficulties with data sharing (see Chapter 5 for recommendations to minimize barriers to data sharing). When the committee asked Solomon how he envisioned being able to move from utilizing the limited data from state contract inspections to utilizing the vast amount of data and resources from all state inspections and data analyses, he responded: “The basis for that is standardization . . . there needs to be an accreditation program that oversees that and says, yes, everyone that’s doing this work is up to these standards whether this is a laboratory, whether this is an inspector, whether this is a system. We need to have a robust auditing system to make sure there is credibility in such a program.” Lack of trust in the ability of state and local programs also exists among groups representing consumers, supported by published reports indicating that, taken as a whole, food safety activities such as outbreak investigations and restaurant inspections have not been adequate (Kelly et al., 2007; Klein and DeWaal, 2008; CSPI, 2009; DeWaal et al., 2009; Moran, 2009). Regulatory Structures and Laws for State and Local Food Safety Programs The FDA’s origins can be traced back to the analysis of agricultural products in the U.S. Patent Office around 1848, a function that was trans- ferred to USDA upon its creation in 1862. The FDA became known by that

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 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS name in 1930 and was transferred to the Federal Security Agency in 1940, which became the Department of Health, Education and Welfare in 1953. Although the FDA is the oldest and most comprehensive food safety agency in the federal government, food safety programs in the states are also of long standing. For example, Florida enacted a food law in 1905, a year prior to passage of the 1906 Pure Food and Drugs Act. Even before that, Massachusetts passed the first general food law in 1784, and in 1850 Cali- fornia enacted “a pure food and drink law” (Darby, 1993). The FDA is responsible for the safety of all foods in the United States, whether produced domestically or internationally, with the exception of meat, poultry, and unshelled egg products, which are under the legal author- ity of USDA. Likewise, each state food regulatory program is responsible for the safety of foods in its jurisdiction, whether produced domestically or internationally. However, state regulatory authority exists only within the borders of the state. Regulatory actions outside the state for products that enter interstate commerce are referred to the FDA for enforcement follow- up in other locations. Table 7-1 lists the various sources of information on state agencies involved in food safety regulation. Currently, the food safety regulatory programs in most of the 50 states are either the responsibility of state departments of health or departments of agriculture (Table 7-2) (FDA, 1993; NASDA, 1999; AFDO, 2001, 2009b). State food regulatory pro- grams, which have varying resources, conduct public health and food surveillance, inspections, and sample analyses on food products grown, processed, packed, held, or sold within the state. Where the food safety program is located in the state department of health, the epidemiological and outbreak investigation function also resides in that state agency as well as with the local county health departments (AFDO, 2009a,b). Likewise, the FDA has the responsibility to conduct inspections in each state for any product (food, drug, cosmetic, or device) under its jurisdiction that will be, is, or has been in interstate commerce. The FDA’s inspections and regulatory actions on foods can be duplicative of those of the states, and there is insufficient planning or coordination between federal and state agencies to prevent multiple agency inspections of food plants. The result may be, for example, the use of limited state or federal resources to inspect one facility multiple times; more important, other facilities remain with no regulatory oversight. Generally, the FDA has delegated enforcement activi- ties at food retail and service establishments to state and local jurisdictions utilizing the Food Code (FDA, 2009a,b), which is published and updated periodically by the FDA. The Food Code provides a framework that local, state, and federal regulators can (but are not required to) apply to be consis- tent with national food regulatory policy. The FDA and AFDO now report

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 ENHANCING FOOD SAFETY TABLE 7-1 Sources of Information on State Agencies Involved in Food Safety Regulation Source Year Content 1993a FDA, Office of Details on state food safety Federal–State laws; 45 states have laws Relations based on the 1938 Federal Food, Drug, and Cosmetic Act; food safety law in Alabama, Iowa, Mississippi, Pennsylvania, and West Virginia was patterned after the 1906 Pure Food and Drugs Act. FoodSafety.gov 2010 No clear delineation of state (interagency federal agencies’ responsibilities on government website current site; links to state about food safety departments of health and information) agriculture. National Association 1999 Detailed description of how of State Departments foods are regulated in each of Agriculture state by agency. Research Foundation Project (http://www. nasda.org/nasda/ nasda/Foundation/ foodsafety/index. html)b FDA, State Retail Ongoing updates at www. Specific information on state and Food Service fda.gov/Food/FoodSafety/ agencies that enforce the Code Regulations RetailFoodProtection/ Food Code at food retail FederalStateCooperativePrograms establishments. Individual State Ongoing updates Individual agency websites Agencies outline responsibilities. a Until 1995, the FDA produced annual reports on state food safety laws. These surveys were discontinued because of a lack of resources. The last survey for which a record exists was conducted in 1993. b Records for each state are located at the following address (with pertinent state inserted): http://www.nasda.org/nasda/nasda/Foundation/foodsafety/WestVirginia.pdf (accessed October 8, 2010).

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 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS TABLE 7-2 State Food Regulatory Programs: Leading Agencies Involved Department of Agriculturea Department of Healtha Other Agencies Alabama Arizona Department of Environmental Florida Arkansas Conservation (Alaska) Georgia California Departments of Consumer Maine Colorado Protection (Connecticut) Michigan Delaware Split between Departments of Minnesota Hawaii Health and Agriculture (Idaho) Nebraska Illinois Department of Inspections and New York Indiana Appeals (Iowa) North Carolina Kansas Split between Departments of Ohio Kentucky Commerce and Agriculture Oregon Louisiana (South Dakota) Pennsylvania Maryland South Carolina Massachusetts Tennessee Mississippi Utah Missouri Virginia Montana Washington Nevada Wisconsin New Hampshire Wyoming New Jersey New Mexico North Dakota Oklahoma Rhode Island Texas Vermont West Virginia Total: 19 states Total: 26 states Total: 5 states aAgency housing the predominant portion of food safety regulatory programs. Most states have some divided authorities between agencies. SOURCES: FDA, 1993; NASDA, 1999; AFDO, 2001, 2009b. that all 50 states have adopted all or portions of the Food Code (AFDO, 2009b; FDA, 2009c). There appear to be no major fundamental differences between state and federal food safety laws, although some state laws are based on the 1906 Pure Food and Drugs Act and others on the 1938 Federal Food, Drug, and Cosmetic Act (FDA, 1993). The states, however, possess some authorities that are absent from the 1938 act. By 1993, for example, 48 states had the statutory authority to embargo or stop the sale of food products, but the FDA does not have that authority under federal statutes. In addition, many states have the authority to revoke licenses or permits for food com- panies that violate food safety requirements or to require destruction of

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 ENHANCING FOOD SAFETY inadequate, there were implications for state appropriations (FDA, 2007c). Nonetheless, states have expressed the desire for a review and modification of this program.12 Second, in 2000, the HHS Office of the Inspector General reported on the FDA’s oversight of state contracts and recommended that the agency take steps to promote equivalency between federal and state food safety standards, inspection programs, and enforcement practices (Brown, 2000). Subsequently, the FDA worked with the states to formulate the Manu- factured Food Regulatory Program Standards, which were intended to establish a uniform foundation for the design and management of state programs that are responsible for the regulation of food processing plants. The standards cover ten areas: regulatory foundation, staff training, inspec- tion, inspection audit, food-related illness and outbreaks and food defense preparedness and response, compliance and enforcement, industry and community relations, resources, program assessment, and laboratory sup- port (FDA, 2007b). In 2008, 5 states evaluated their programs against these standards, followed by an additional 25 states in 2009. The principles of this program have also been applied to evaluate foreign food safety programs, such as those in China (Solomon, 2009a,b). Solomon (2009b) reported that the FDA had used these standards in establishing agreements with China’s Administration of Quality Supervision, Inspection, and Quar- antine to enhance the regulatory structure in that country. The increased participation of states is promising, and the FDA should be encouraged to review the scope of the program to ensure that it covers all phases of the food chain from production to consumption. The committee agrees with previous recommendations for standardiza- tion of all state programs (FDA, 2007b) that are established by the FDA to foster nationwide equivalence with respect to food safety management. As of this writing, 25 states are implementing the Manufactured Food Regula- tory Program Standards, which leads the committee to conclude that the integration process is feasible (Solomon, 2009a). For other states, an infu- sion of resources, as well as increased training, will be necessary to meet those minimal federal standards. Oversight of State Programs by the FDA Once standards have been established, methods for standardization are in place, and integration has been achieved, the FDA’s major role should be to maintain and revise the standards as necessary; to provide profes- sional expertise, training, and oversight; and to audit the inspections and 12Personal communication, Marion Aller, Director of the Division of Food Safety, Florida Department of Agriculture and Consumer Services, April 20, 2009.

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 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS programs of its food safety partners. The FDA already performs limited oversight of state programs through either inspector or program audits. In an inspector audit, an FDA inspector observes a state inspector at work; a program audit consists of the FDA’s evaluation of a state program. As noted earlier, the FDA has established a goal of auditing 7 percent of state contract inspections and has been criticized for not meeting this goal (FDA, 2006). To the committee’s knowledge, there are no FDA audits of local food inspections. The FDA’s FPP (FDA, 2007a) proposes third-party auditing as a means by which oversight of food safety programs and of adherence to regulations and standards can be conducted (see Chapter 4). Large food retailers now require third-party auditing to confirm that food safety practices are being followed by their suppliers. This type of oversight is being conducted by industry in part because the FDA currently is unable to provide such audit- ing (GAO, 2008b). In the FPP, the FDA recognizes the significant role third-party auditors now play and hence seeks to provide some level of standardization for these audits. Of interest, other federal, state, and local agencies are also proposed to have a role as third-party auditors (FDA, 2007a). In practice, the com- mittee recommends that the FDA serve as auditor of all state inspections and food safety programs. However, the committee also concludes that there is a fundamental difference between the auditing role of other gov- ernment agencies and commercial third parties in that other government agencies should be considered equal partners in governing food safety. Thus, the committee objects to the reference to other government agencies, including state and local agencies, as “third parties” in the FPP because the term implies that the FDA will not consider those agencies equal partners in ensuring food safety. Equivalency of State and Federal Inspections Regulatory officials are frequently asked to delineate the differences between state and federal food inspections in an effort to establish the mean- ing of equivalency. Although the legal requirements are roughly the same for state and federal food safety inspections, program implementation, resources, and capabilities vary substantially among the states, as sug- gested by the AFDO surveys. For example, both state and FDA inspections are based on the applicable Code of Federal Regulations (CFR), Title 21, requirements as they have been adopted by the states. Although states have adopted the CFR, they may have their own regulations as well. Examples are a standard of identity for honey, syrup, or some other food not present in the federal regulations (FDACS, 2009) or the requirement of HACCP plans for sprout production in the state of Florida.

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 ENHANCING FOOD SAFETY In terms of program implementation, there are differences not only among states but also between the states and the federal government. As a relevant example, most states are unlike the FDA in that inspectors are dedicated solely to food safety, with no responsibility to perform drug or device inspections. An additional difference between federal and state inspections is that the latter focus primarily on reviewing operations in progress rather than on reviewing records, which is more often the focus of FDA inspections. As a result, federal inspections usually take longer than state inspections.13 One similarity is that both federal and state inspec- tions require internal auditing of inspectors by supervisors to ensure that appropriate inspectional methods are being used. Also, like federal inspec- tors, state inspectors are often trained through FDA courses; an important difference in this area in that the courses currently are not mandatory for states. Given these differences, and in the absence of criteria for standardiza- tion, there appears to be a legitimate concern within the FDA about the quality of state relative to federal inspections as well as the qualifications and training of state inspectors. As detailed in Chapter 8, the commit- tee recommends a review and update of the inspectional procedures and training curricula for both federal and state inspections and the standard- ization of all state food safety inspectional programs, including inspector training. The FDA should review and update curricula specific to general food inspections as well as to particular types of inspections (e.g., seafood HACCP) for state and federal inspectors and provide sufficient resources to deliver this training. As mentioned in Chapter 8, the committee supports the partnership of the FDA with others, such as the IFPTI, for the delivery of training for inspectors and auditors. Risk-Based Approaches at the State and Local Levels The states apply some of the concepts embraced by a risk-based approach to making regulatory decisions. For example, some use qualita- tive and quantitative risk assessments and prioritization models produced by the FDA and the academic sector, such as published risk assessments on Listeria monocytogenes and methyl mercury. Most state programs prioritize inspections and regulatory scrutiny based on the perishability or known contamination of a food, previous inspectional and analytical history for a firm, published problems with a particular food product, publication of federal recall records, and other knowledge. However, the implemen- tation of a common risk-based approach to food safety management is 13 Personal communication, John T. Fruin, Florida Department of Agriculture and Consumer Services, 2009.

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 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS unlikely until such an approach is instituted at the federal level. Once a risk-based approach is in place at the FDA, the agency should work with state and local governments to facilitate a uniform implementation of that approach. KEY CONCLUSIONS AND RECOMMENDATIONS State and local government food safety regulations and programs— including food and public health surveillance and data analysis, inspection, and outbreak investigation—remain a mainstay in protecting the U.S. food supply from unintentional and intentional contamination. An integrated food safety system would have many advantages, such as leveraging efforts, minimizing unnecessary duplication, improving responsiveness when crises occur, and ensuring a reasonable frequency of regulatory scrutiny. Despite past calls for integration of local, state, and federal food safety programs, only limited progress has been made in this regard. Most of this progress has been accomplished just recently, as evidenced by the IFSS announced by the FDA in fall 2009. This delay has been largely a function of barriers including funding limitations; state-to-state variability in food safety programs, goals, and support; past legal interpretations that integra- tion was not possible; and institutional resistance to change and cultural barriers. Also hampering full integration is the lack of a formal federal process to support, evaluate, or guide state and local food safety programs. Nonetheless, the FDA does have standards in place that, if broadened and properly implemented, could serve as a basis for the harmonization of state and local food and feed safety programs as well as their integration with federal programs. Based on the number of states that are implementing the Manufactured Food Regulatory Program Standards, it appears that the integration process is feasible. The FDA, working with the states, is mov- ing forward to establish core competencies and the credentialing process necessary to ensure adequate performance by inspectors (Brown, 2000; Solomon, 2009a). The committee recognizes that there will be initial and ongoing costs associated with the integration proposed in this chapter. Certain states will have difficulty achieving the recommended levels of funding and resources. However, mechanisms within the FDA (e.g., contracts, grants, incentives) can be used to enable state programs to meet federal standards in a rela- tively short period of time. The committee recognizes that questions of legal authority regarding the roles of the states, CDC, and the FDA in the investi- gation of foodborne illness could impede the flawless, full integration of all local, state, and federal food safety activities. The committee recommends that an appropriate panel perform an overarching analysis of the relevant authorities and that, if necessary, Congress provide clear authorities to the

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0 ENHANCING FOOD SAFETY FDA to achieve the goal of a full integration of local, state, and federal food safety activities to the benefit of the nation’s public health. Recommendation 7-1: The FDA should utilize the surveillance, inspec- tion, and analytic systems and resources of state and local governments in a fully integrated food safety program. As a prerequisite to such integration, the FDA should work with the states and localities to har- monize their programs by providing adequate standards and overseeing their implementation, beginning with those states that meet such stan- dards. Standardization and integration of state and local food safety programs should be conducted in an evolutionary fashion, with inter- mediate goals and associated performance measures. The White House FSWG should make integration of federal and state food regulatory programs a priority and provide leadership to the already established IFSS Steering Committee. The agency should provide training, auditing, and oversight of state and local programs and should facilitate nation- wide implementation of the recommended risk-based approach. Joint responsibilities of the FDA and the states should include the following: • Both the states and the FDA should review the state statutory authorities in food and feed safety to ensure adequate protection. If deficiencies are found, the FDA should provide specific recom- mendations for any additional authorities needed by the states. • The FDA should work with state and local governments to ensure that the risk-based approach is embraced at all levels. • The FDA and the states should ensure integration of the feed regulatory program and, through the state veterinarians’ offices, actively integrate surveillance of zoonotic diseases into the overall food safety program of each state. • The FDA and each state and local government should enact for- mal agreements to delineate the responsibilities of each party and develop a timetable for integration. The FDA should also provide a mechanism (e.g., contracts, grants, incentives) whereby the funds necessary to support full integration are provided to each state government on the basis of its needs to achieve national standards. State programs will not be equal in size or inspection activity, as the location of food establishments is concentrated in certain geographic areas, and the supportive mechanism may be needed for multiple years based on the state’s available resources and the number and nature of food firms within its boundaries.

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 INTEGRATING GOVERNMENT FOOD SAFETY PROGRAMS The responsibilities of the states should include the following: • The states should cooperate with the FDA in standardization pro- cesses and commit to obtaining sufficient resources and expertise to achieve standardization. • The states should work with the FDA to ensure compatibility of communication systems and information technology to allow timely sharing of inspection findings and analytical data. • The states should work to achieve certification of analytical and inspection programs and, when necessary, seek additional funding through the FDA to assist in this process. The FDA’s responsibilities should include the following: • The FDA’s role in food safety should focus on standards set- ting, nationwide implementation of the recommended risk-based approach, and training and oversight of state and local food safety regulatory programs, not on increasing internal resources to con- duct all regulatory activities at the federal level. • Accordingly, the FDA should provide appropriate training to state and local surveillance and inspection personnel, with a focus on supporting the risk-based food safety management approach. • The FDA should provide the necessary standards. As a first step, a review of the Voluntary National Retail Food Regulatory Program Standards and Manufactured Food Regulatory Program Standards should be undertaken to ensure that they are adequate for all areas of food and feed regulatory programs, not just the retail and pro- cessing areas. • As recommended in Chapter 8, after review by an independent body, the FDA’s inspection procedures should be revised to pro- mote greater efficiency and should be adopted as standards for all food and feed inspections. • The FDA should oversee state and local food safety programs by performing regular audits of their inspections and other activities as appropriate at a prescribed annual rate. The agency should also work with the states to ensure coordination with regard to inspection of food facilities to avoid unnecessary duplication of effort. • The FDA should immediately utilize analytical data from appropri- ately ISO 17025–certified state food laboratories. For those states not yet ISO-certified, the FDA should work, and assist with fund- ing if necessary, to facilitate ISO 17025 certification over the next 10 years.

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 ENHANCING FOOD SAFETY • State and local food safety programs should be fully recognized as partners in the nation's food safety program and not as third parties. The FDA’s FPP needs to be revised to reflect this philo- sophical change. • The FDA should identify intermediate goals with associated perfor- mance measures for the process of standardization and integration of state and local food safety programs as part of the plans for implementation. In addition, the FDA should certify and integrate state and local government programs as they meet the standards. REFERENCES AFDO (Association of Food and Drug Officials). 2001. State Resource Surey. York, PA: AFDO. AFDO. 2009a. State Food Safety Resource Surey. York, PA: AFDO. AFDO. 2009b. AFDO Food Laboratory Standard Methods Accreditation Surey. York, PA: AFDO. http://www.afdo.org/Resources/Surveys/Lab2009.cfm (accessed February 26, 2010). Aller, M. 2009. Florida Submission to AFDO State Food Safety Resource Assessment. York, PA: AFDO. Barnes, R. 2009. Discussion Panel: FDA and State Inspections of Food. Institute of Medicine/ National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Becker, G. S. 2008. U.S. Food and Agricultural Imports: Safeguards and Selected Issues. Washington, DC: Congressional Research Service. Becker, G. S. 2009. Food Safety on the Farm: Federal Programs and Selected Proposals. Washington, DC: Congressional Research Service. Brown, J. G. 2000. FDA Oersight of State Food Firm Inspections: A Call for Greater Accountability. Boston, MA: U.S. Food and Drug Administration. Burditt, G. M. 1995. The history of food law. Food & Drug Law Journal 50:197–201. Burke, G. 2007. Spinach recall sparks oversight calls. USA Today, August 31, 2007. CRS (Congressional Research Service). 2007. Federal Food Safety Systems: A Primer. Report num- ber RS22600. www.nationalaglawcenter.org/assets/crs/RS22600.pdf (accessed March 18, 2010). CSPI (Center for Science in the Public Interest). 2009. CSPI Finds a Troubling Decline in Foodborne Outbreak Inestigations by State Health Officials. Washington, DC: CSPI. http://www.cspinet.org/new/200912231.html (accessed March 31, 2010). CSTE (Council of State and Territorial Epidemiologists). 2009. 00 National Assessment of Epidemiology Capacity: Findings and Recommendations. Atlanta, GA: CSTE. Darby, W. 1993. Symposium: Historical overview of the safety of the food supply: Introduc- tion. The Journal of Nutrition 123:277–278. DeWaal, C. S. 2003. Safe food from a consumer perspective. Food Control 14(2):75–79. DeWaal, C. S., X. A. Tian, and D. Plunkett. 2009. Outbreak Alert! Analyzing Foodborne Outbreaks –00. Washington, DC: Center for Science in the Public Interest. http:// cspinet.org/new/pdf/outbreakalertreport09.pdf (accessed March 31, 2010). FDA (U.S. Food and Drug Administration). 1993. State Law Data. Rockville, MD: FDA. FDA. 2006. State Contracts­Ealuation of Inspectional Performance: Appendix H Model Standard Agreement ORA Field Management Directie No. . Washington, DC: FDA.

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