Enhancing Food Safety: The Role of the Food and Drug Administration (2010)

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Chapter: 7 Integrating Federal, State, and Local Government Food Safety Programs

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Suggested Citation:"7 Integrating Federal, State, and Local Government Food Safety Programs." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.

7
Integrating Federal, State, and Local Government Food Safety Programs

The 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 programs 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 million food establishments 1 (including restaurants and retail establishments), and more than 2 million farms (Mavity, 2009). Given the size, complexity, 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 organizations 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).

Personal communication, Chad Nelson, FDA, October 13, 2009.

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 government; (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 interchangeably to mean “interaction between [entities] that is largely beneficial to all those participating.” 2

This chapter presents the committee’s rationale for supporting an integrated 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, conversations with federal government employees, individual committee members’ regulatory and other experiences, and past reports addressing this topic.

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 regulatory initiatives are aimed at making proposed reforms a reality (Hogan & Hartson, LLP, 2009). This section reviews the recommendations for integration 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 recommendations, 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-

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 Center 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 Territorial 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 incomplete 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 saying, “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

Personal communication, Joseph Corby, executive director of AFDO, August 25, 2009.

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 articulated. 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 intergovernmental 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 integration 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 organizational 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 enhancements 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 development 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 collaboratively 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 adoption by state legislatures, which continues to be updated for state adoption (Burditt, 1995). At the request of the Tomato Forum in

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 partnerships 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 relationships, 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 million grant from the Kellogg Foundation to create a food protection training institute. Established in collaboration with the International 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 permanent 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 companies 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 development for specific commodities, such as produce, concerns remain regarding many aspects of traceability. Most notable among these

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 integration 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 commissioner 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-

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 Bulletin, 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 Commissioner for Compliance Policy, Office of Regulatory Affairs (ORA), FDA, said: “As we move with further integrating with the states [on the recommendations 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 transferred to USDA upon its creation in 1862. The FDA became known by that

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 California 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 authority 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 programs, 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 activities 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 consistent with national food regulatory policy. The FDA and AFDO now report