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

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.
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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 establishments1 (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).

1

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

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.
×

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.

2

Definition found at http://www.merriam-webster.com/.

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.
×

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-

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.
×

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

3

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

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.
×

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

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.
×

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

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.
×

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-

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.
×

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

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.
×

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

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.
×

TABLE 7-1 Sources of Information on State Agencies Involved in Food Safety Regulation

Source

Year

Content

FDA, Office of Federal–State Relations

1993a

Details on state food safety laws; 45 states have laws 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 (interagency federal government website about food safety information)

2010

No clear delineation of state agencies’ responsibilities on current site; links to state departments of health and agriculture.

National Association of State Departments of Agriculture Research Foundation Project (http://www.nasda.org/nasda/nasda/Foundation/foodsafety/index.html)b

1999

Detailed description of how foods are regulated in each state by agency.

FDA, State Retail and Food Service Code Regulations

Ongoing updates at www.fda.gov/Food/FoodSafety/RetailFoodProtection/FederalStateCooperativePrograms

Specific information on state agencies that enforce the Food Code at food retail establishments.

Individual State Agencies

Ongoing updates

Individual agency websites 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).

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.
×

TABLE 7-2 State Food Regulatory Programs: Leading Agencies Involved

Department of Agriculturea

Department of Healtha

Other Agencies

Alabama

Florida

Georgia

Maine

Michigan

Minnesota

Nebraska

New York

North Carolina

Ohio

Oregon

Pennsylvania

South Carolina

Tennessee

Utah

Virginia

Washington

Wisconsin

Wyoming

Arizona

Arkansas

California

Colorado

Delaware

Hawaii

Illinois

Indiana

Kansas

Kentucky

Louisiana

Maryland

Massachusetts

Mississippi

Missouri

Montana

Nevada

New Hampshire

New Jersey

New Mexico

North Dakota

Oklahoma

Rhode Island

Texas

Vermont

West Virginia

Department of Environmental Conservation (Alaska)

Departments of Consumer Protection (Connecticut)

Split between Departments of Health and Agriculture (Idaho)

Department of Inspections and Appeals (Iowa)

Split between Departments of Commerce and Agriculture (South Dakota)

Total: 19 states

Total: 26 states

Total: 5 states

a Agency 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 companies that violate food safety requirements or to require destruction of

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.
×

contaminated products. The FDA’s Office of Federal–State Relations confirms that all states now have some form of legislative authority for food and drugs; however, there are wide variations among states, such as in the number of personnel. Because of a lack of resources, no annual surveys of state regulatory authorities have been conducted since 1995; the last survey of state food laws for which there is a record was conducted by the National Association of State Departments of Agriculture in 1999.4

State feed programs are an integral part of the food safety system since feed contamination, either chemical or microbiological, becomes a food safety issue for humans through the consumption of food animals or exposure to the contaminated feed. Likewise, humans are exposed to certain zoonotic diseases (those transmitted from animals to humans) through the food and feed chain. Surveillance for zoonotic diseases is a responsibility of state veterinarians. Coordination of state efforts to monitor food animals’ feed supply and conduct surveillance for human exposure to zoonotic diseases is part of an integrated food safety system. The FDA has reported that it is currently developing process control regulations for animal feeds similar to the voluntary national Retail Food Regulatory Program Standards and Manufactured Food Regulatory Program Standards (FDA, 2007b, 2009d).

Nearly all feed mills manufacture medicated feeds; however, only those that produce medicated feeds with specific drugs and drug concentrations are inspected routinely by the FDA or contract state inspectors. Feed mills making nonmedicated feeds are generally regulated only by states; the exception is federal regulations concerning bovine spongiform encephalopathy (BSE). Most of these mills either produce organic feed or are species specific (e.g., horse feeds). The FDA stated during testimony to the committee that regulations addressing medicated animal feed are not uniform at the state level, and therefore medicated feed inspections under FDA contracts are conducted under federal law.

Level of Regulatory Activity in the States

Several publications have reported on the number of activities (e.g., inspections, enforcements) conducted at the local, state, and federal levels (AFDO, 2001; HHS/FDA, 2009), including food- and feed-related activities. AFDO is currently finalizing an additional survey of state and local food safety regulatory programs to update previous statistics (AFDO, 2009a,b). The preliminary results (corresponding to 64 of the total 75 state agencies in 47 states at the time of this writing) show that, as in

4

Personal communication, Richard Barnes, Director, Division of Federal–State Relations, FDA, June 2009.

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.
×

TABLE 7-3 State and Local Food Safety Activities

Food Safety Activity

2001

Inspections

 

Food processing/repackaging facilities (including dairy)

68,162

Farms

159,794

Food service establishments (institutional and retail)

1,229,638

Retail food stores

516,033

Animal feed (feed manufacturers and distributors, bovine spongiform encephalopathy inspections, rendering plants)

23,984

Other (food warehouses, food transportation vehicles, food salvage operations, etc.)

47,697

Investigations

 

Foodborne illness outbreaks

3,075

Other (trace-backs, complaints, chemical residues, etc.)

86,840

Enforcement (embargo, warning letters, food recalls, etc.)

128,430

Samples analyzed (food chemistry, microbiology, pesticide residue)

328,065

SOURCE: AFDO, 2001.

2001, the states conduct a substantial number of activities.5 For example, 2.5 million state and local food safety inspections were reported for foods regulated by the FDA, with the majority being conducted in food service and retail stores, categories the FDA has delegated to the states. In all states, food processing and repackaging establishments are far fewer in number than these categories (Table 7-3).

Florida and Texas are two examples of states that devote substantial resources to food safety. In 2008, the state food regulatory program of the Florida Department of Agriculture and Consumer Services conducted 55,364 food safety inspections in various categories (Aller, 2009).6 The department supports 184.5 full-time equivalents (FTEs) dedicated to food safety inspection and investigation and 62 FTEs providing administrative support. In 2008, the Texas Department of Health Services conducted 24,829 food sample analyses and took 1,918 enforcement actions (Sowards, 2009).7 Both state food laboratories are International Organization for Standardization (ISO) 17025 certified.

As noted, state food safety programs are diverse. Data from the 2001

5

Personal communication, Joseph Corby, Executive Director of AFDO, August 25, 2009.

6

Personal communication, Marion Aller, Director of the Division of Food Safety, Florida Department of Agriculture and Consumer Services, April 20, 2009.

7

Personal communication, Dan Sowards, Food and Drug Safety Officer, Division for Regulatory Services, Texas Department of State Health Services, May 19, 2009.

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.
×

AFDO State Food Safety Resource Survey (AFDO, 2001) show that the numbers of inspections, enforcement activities, and foodborne illness outbreaks differ greatly among the states. Although these disparities could be due to the numbers of facilities/establishments in each state, they also suggest that the emphasis on food safety varies by state. AFDO collected data on inspections of all types of establishments and activities: food processing/repackaging facilities, dairy plants, milk plants, dairy farms, retail food service establishments, retail food stores, wholesale meat processors, meat plants, slaughterhouses, feed manufacturers and distributors, BSE inspections, rendering plants, food transportation vehicles, food salvage operations, farm production, and food warehouses. Based on this survey, the total number of inspections conducted in 2001 ranged from 80 in one state to more than 100,000 in others; the average number of inspections was approximately 50,000 per state.

Information on statutory and enforcement activities (embargo/seizure, stop sale, health advisories, monetary penalties, license/permit revocations, injunctions, criminal prosecutions, warning letters, and informal hearings) was also collected in the AFDO survey. Some states reported fewer than 20 activities, while others reported thousands. Likewise, 13 states reported 10 or fewer outbreaks of foodborne illness, while others reported hundreds (AFDO, 2001).

In contrast with the number of state and local inspections in processing and repackaging facilities (more than 50,000 reported in 2001), the FDA reported only about 16,000 food establishment inspections and 8,000 inspections of animal drug and feed programs for 2008 (HHS/FDA, 2009). The states performed about 60 percent of the food establishment inspections for the FDA and 73 percent of the animal drug and feed program inspections.

Public Health Surveillance and Outbreak Investigations

As stated in Chapter 3, rapid detection and investigation of foodborne illnesses, whether sporadic or outbreak associated, are critical to public health management and risk-based decision making. Development of the epidemiological surveillance system necessary to support this function requires effective and efficient communication and cooperation among a large number of partners, including scientists and laboratories at the local, state, and federal levels (see also Chapter 5). A further complicating factor is the high degree of variability in funding and data collection at the state level. This variability was illustrated in a recent survey conducted by Safe Tables Our Priority, which demonstrated wide variation in response to foodborne illness outbreaks. Nearly 60 percent (23 of 39) of the responding states reported that they did not have electronic capabilities to link inves-

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.
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tigative data (Produce Safety Project, 2009). This finding is similar to that cited in the December 2009 report of the Council of State and Territorial Epidemiologists: while 90 percent of the 46 states reporting had databases compliant with the National Electronic Disease Surveillance System, only 53 percent had automated electronic laboratory reporting and 41 percent web-based provider reporting. The report also documents a reduction in the workforce, with 10 percent fewer epidemiologists working in state health departments in 2009 than in 2006 (CSTE, 2009). Since the first-line response to foodborne illness outbreaks is investigations conducted primarily by county and state health departments, with pertinent information eventually flowing to federal agencies such as the FDA or the U.S. Centers for Disease Control and Prevention (CDC), this decrease in regional professional personnel is disturbing.

Food Analysis Data

Some states routinely analyze food samples for contaminants. These data can be invaluable in measuring the effectiveness of industry preventive programs and in providing much-needed information to support risk-based food safety efforts. If these data are to be used in a national food safety system, their quality must meet defined standards of sampling and analysis. To this end, AFDO recently completed a Food Laboratory Accreditation Survey designed to gather information on what is needed for acceptance of analytical results between allied state and federal food safety regulatory agencies (AFDO, 2009a,b). Many state laboratories are equivalent to federal laboratories with regard to staffing numbers and qualifications of both inspectional and analytical personnel and analytical capabilities (e.g., facilities, instrumentation). Some states’ food analytical laboratories have achieved ISO/International Electrotechnical Commission (IEC) 170258 accreditation, while others are progressing rapidly through this demanding process (AFDO, 2009a,b). Solomon reported in November 2009 that all FDA laboratories were ISO 17025 accredited, as were nine states’ food safety laboratories.9

Sharing food safety data remains a challenge for various reasons, both technical and cultural (see also Chapter 5), although some valuable initiatives to this end have been undertaken. The eLEXNET system, for example, is a web-based information network that allows the FDA to compare laboratory analyses of contaminants in food or food-producing animals from

8

ISO/IEC 17025 is the main standard used by testing and calibration laboratories, originally issued by ISO in 1999 and revised thereafter. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to produce valid results consistently.

9

Personal communication, Steven Solomon, ORA, FDA, November 17, 2009.

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.
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different laboratories. It is also used as a repository for method validation and serves other roles in support of the Food Emergency Response Network (FERN) (FERN, 2009).10 This initiative, coordinated by the FDA, began as a pilot with 8 participating laboratories and has grown to include 135 laboratories representing federal, state, and local government agencies in all 50 states. A needed enhancement and a specified goal of the FDA’s ORA (FDA, 2009c,e) is for eLEXNET to have the capability to alert other users of the system about any significant findings (e.g., a contaminant in a food or a finding outside the normal parameters indicating a potential event) that might necessitate a rapid response.

Another initiative of note is an innovative database developed by the National Center for Food Protection and Defense in collaboration with AFDO, with the purpose of facilitating data sharing in the area of food defense (AFDO, 2009a,b). FoodSHIELD is designed as a web-based platform with a communication portal, a training center, and two databases that capture the capabilities, capacity, technology, and expertise of agriculture, health, environment, and emergency response agencies and their supporting laboratories. Users of FoodSHIELD are varied but are mainly government public health officials (FoodSHIELD, 2009).

FDA INTERACTIONS AND COLLABORATIONS WITH THE STATES

The FDA maintains various interactions and joint programs with state and local regulatory agencies involved in food safety. These include such activities as annual scope-of-work planning sessions, training courses, contracts for food and feed inspections, grants, cooperative agreements, confidentiality agreements, commissioning, inspector and program audits, and joint inspections. In addition, the FDA has memorandums of understanding (MOUs) with the states for various functions, which are issued chiefly to facilitate cooperation and planning.

Training of Inspection Personnel

The adequacy of state and local food safety inspectional programs and the associated training is poorly documented. Solomon (2009a,b) stated that the Office of Regulatory Affairs University (ORAU) offers 130 training courses to state food safety programs, but they are not mandatory. Since 1993, the ORAU program was initiated, 10,700 professionals have participated, and more than 83,000 courses have been completed. In 2009, for example, 37 courses were offered in food protection, including at the retail level and for milk and shellfish, 34 on manufactured foods, 6 on feed

10

See www.fernlab.org (accessed December 30, 2009).

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.
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and veterinary medicine, and 23 on investigative responses, including incident command, rapid response, and farm investigations. However, access to this training is far from ideal, since an individual state has only one or two training slots available in locations far from home districts. In addition to the efforts of ORA, AFDO is now providing education and training to food protection professionals through the IFPTI, established by a $2 million grant from the Kellogg Foundation.11 The establishment of minimal training requirements and the provision of appropriate training opportunities to meet those requirements are essential if state personnel are to be integrated successfully into the federal food safety program (see Chapter 8). The FDA Manufactured Food Regulatory Program Standards (discussed below) could serve as a basis for providing such minimal requirements as standards for state employees.

Grants, Cooperative Agreements, and Contracts

The FDA has awarded grants, cooperative agreements, and contracts to the states for more than three decades. A grant provides financial assistance to an eligible individual or group to carry out an approved project or activity in which the agency will have no substantial programmatic involvement with the recipient. In 2009, FDA grants provided $17.5 million in state funding to design and implement response, intervention, innovation, and prevention food safety programs—the four key tenets of the FPP. Cooperative agreements are similar to grants in that they give state and local governments the opportunity to enhance existing programs or develop new programs to improve public health. Currently, cooperative agreements are used in cases of substantial federal programmatic involvement.

According to Solomon (2009a,b), the FDA currently has about 43 contracts in 41 states covering a total of about 10,500 inspections. Of these inspections, 9,000 are related to Good Manufacturing Practices (GMPs), 1,100 to seafood HACCP, 47 to juice HACCP, and 53 to low-acid canned foods (see also Chapter 8). However, the total number of FDA-sponsored state contract inspections represents only 0.4 percent of the more than 2.5 million state and local food safety inspections conducted each year (AFDO, 2009a,b). In addition, 37 states currently have contracts or cooperative agreements to conduct feed inspections for the FDA. In fiscal year 2008, those states performed more than 6,000 contracted feed inspections (including GMP and BSE inspections), or approximately 76 percent of all FDA feed inspections. The FDA also has 18 contracts with states to perform tissue residue testing; the states have reported conducting 635 such

11

Personal communication, Joseph Corby, Executive Director of AFDO, August 25, 2009.

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.
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inspections (Solomon, 2009a,b). The number of federal-led inspections is low compared with the number of state-led inspections.

States provide information on contract inspections through electronic access to the Field Accomplishments and Compliance Tracking System. For example, the FDA has a goal to audit 7 percent of contract inspections to determine their equivalency to FDA food inspections and ensure the proper performance of state partners. The FDA has been criticized in the media, most recently in 2009 (Burke, 2007; Schmidt, 2009; Scott-Thomas, 2009), for not meeting this oversight goal. If state and local programs were fully integrated, with adequate standardization and oversight, the FDA could raise its rate of inspection from once every 3–10 years to annually. Once state and local programs have been integrated, the committee suggests that the FDA meet this goal to ensure appropriate inspection and enforcement procedures. If this goal is met, and if the FDA increases its reliance on state and local inspections, the goal can be increased to a higher auditing rate.

State-led food inspections under FDA contracts are performed under state law since states have greater authority than the FDA to embargo shipments, remove licenses, or destroy products (Barnes, 2009). On the other hand, many states lack sufficient regulatory authority in the feed area, so they perform feed inspections under the FDA’s commissioning (see below).

Cooperative agreements with the states fund rapid response teams and FERN. The rapid response teams are funded for a specified amount of time with the purpose of enhancing regulatory and surveillance programs for food protection at the state level. The agreements typically provide funds for program assessment, additional equipment, supplies, personnel, and training. The success of the teams depends on their ability to support the infrastructure needed to sustain extensive cooperation and coordination with FDA district offices, especially during emergencies. The first team was the California Food Emergency Response Team, established in 2003; since then, eight additional states (Florida, Massachusetts, Michigan, Minnesota, North Carolina, Texas, Virginia, and Washington) have been granted funds to establish such teams.

FERN encompasses state agricultural, environmental, public health, and veterinary diagnostic laboratories in partnership with federal agencies, including the FDA; CDC; USDA’s Food Safety and Inspection Services, Animal and Plant Health Inspection Service, and Agricultural Marketing Service; the U.S. Department of Defense; the Federal Bureau of Investigation; the U.S. Environmental Protection Agency); and the U.S. Department of Homeland Security (FERN, 2009). FERN is organized into a national program office with regional coordination centers that, together with the laboratories, coordinate responses and ensure integration within the network. The FERN laboratories have assisted with method development and

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.
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technical expertise on limited occasions. The FERN system has been activated only on a limited basis, including the 2006 outbreak of E. coli O157: H7 in spinach, the 2007 outbreaks associated with melamine in infant formula and pet food, the 2008 outbreak of Salmonella Saintpaul in Mexican peppers, and the 2008 outbreak of Salmonella in peanut butter.

Confidentiality Agreements and Commissioning

Forty-four states are covered by annual confidentiality agreements. The individuals signing the agreements are bound to keep confidential any information designated as such by the FDA.

Commissioning of state officials is the process by which the FDA allows the sharing of confidential information between parties, such as between the agency and a state department of health or agriculture. Commissioning has historically been reserved for high-ranking officials, and only about 1,200 state officials and 9,500 Customs and Border Protection officials are commissioned (Solomon, 2009a,b). The program was designed to better utilize state and local officials in the performance of specific functions subject to federal jurisdiction and confidentiality requirements (e.g., the conduct of examinations or inspections). Commissioning is usually limited to a specified period of time.

In its deliberations, the committee discussed the limited benefits of the current commissioning mechanism. In particular, restricting the number of high-ranking officials commissioned by the FDA in each state leads to barriers in information sharing at the state level. The committee suggests expanding the use of the commissioning process as a mechanism in order to better leverage and integrate the resources of state inspectional personnel (see Chapter 8). The committee believes that expanding use of the FDA’s authority to commission both food and feed inspectors would provide an excellent mechanism for delegating agency functions and, when combined with funding mechanisms to promote sustainability of state food safety programs, would facilitate the overall integration of state and federal food safety efforts.

Memorandums of Understanding

The FDA has MOUs with the states for various functions, chiefly to facilitate cooperation and planning. However, MOUs are not binding; are written in general language expressing broad goals, such as a commitment to joint planning and coordinated inspections; and often are not utilized. Previously enacted MOUs between the FDA and the states have basically been general statements of intent; GAO has previously reported on the underutilization of the FDA’s interagency agreements (GAO 2004a,b,

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.
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2005b). The committee suggests that the FDA develop and utilize more detailed formal agreements, outlining specific expectations, with all states on all food and feed safety matters.

INTEGRATION THROUGH STANDARDIZATION AND OVERSIGHT OF FOOD SAFETY PROGRAMS

The integration and analysis of food safety information and data derived from the inspections and analyses of all partners and stakeholders are of the utmost importance for (1) understanding the food safety system in its totality, (2) ensuring the trust of the consuming public, (3) providing the public with the appropriate level of regulatory scrutiny of the U.S. food supply, (4) allowing the goals of the FDA’s FPP to be accomplished, and (5) implementing nationwide the risk-based approach recommended by the committee in Chapter 3. Further, collaboration, partnerships, and data sharing with the states are essential when resources need to be prioritized, but these cannot occur without an adequate foundation in legal authority, standardization, and harmonization of FDA, state, and local programs. The recommendations offered in this report, as well as those of Taylor and David (2009), outline the steps necessary for such collaboration and partnership to occur and encourage the FDA to implement an integrated national food safety system. The FDA cannot be expected to fully achieve the goals of its FPP, in which the states are partners, without fundamental intra-agency changes in culture, structure, and function, as well as interagency integration with state and local partners.

Strategic Planning, Leadership, and Cooperation

Increasing FDA funding or personnel without incorporating the fundamental changes recommended by the committee will not be sufficient to enhance food safety as outlined in this report or to allow the goals of the FPP to be accomplished. Careful strategic planning is necessary before an integrated approach can be implemented. The FDA has produced a report of recent activities toward establishing an integrated national food safety system (FDA, 2009c,e). This document recognizes that “to be successful, an integrated national food safety system must build upon the work currently being done by FDA and our regulatory and public health partners” (FDA 2009c, p. 4).

Constructive changes in federal food safety programs are under way, such as the formation of the FSWG, new leadership in the FDA, creation of the agency’s Office of Foods under the Office of the Commissioner, regulatory changes proposed by the FDA, and proposed congressional actions. Efforts are under way to establish task groups internal to the FDA

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.
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in the areas of national work planning, policy and procedures, national standards, training and certification, oversight, emergency response, performance outcomes and measures, and laboratories, with implementation expected over the next 5 years (FDA, 2009c,e). According to the FDA, a steering committee was established to maintain necessary communication with the FSWG via the deputy commissioner for foods (see Chapter 11). The committee supports this initiative and concludes that the FSWG, with the enhancements outlined in Chapter 11, needs to maintain a leadership role to ensure that these changes are accomplished. The committee also recognizes that integration will likely not be completed for some years, and it looks forward to seeing progress toward the system’s ultimate implementation. The success of this initiative will depend on sustainable support and cooperation among the various organizational structures created (e.g., steering committees, coordinating committees, task groups, partnership for food protection work groups).

The process of integration will require a sustained spirit of collaboration. In the past, successful cooperation has depended mainly on personal relationships and trust among individuals and agencies. The committee recognizes the various ways in which cooperation is being attempted and the recent improvements in sharing of regulatory responsibilities among various jurisdictions (federal, state, and local). The committee recognizes the barriers to collaboration (including the fact that it cannot be mandated), and it emphasizes the importance of strong leadership in achieving and sustaining this important goal.

Standardization of State Programs

State and local governments have jurisdiction over the safety of food products that do not cross state or local boundaries. As noted above, despite similarities in the legal foundation for food safety, state and local programs vary. To integrate food safety as defined by the committee, these programs and their implementation must be evaluated against a minimum standard and ultimately standardized and harmonized. Two programs currently exist within the FDA for assistance that, if enforced, could be used in state standardization.

First, the Voluntary National Retail Food Regulatory Program Standards were introduced as a guide to designing and managing retail food regulatory programs. In 1998, as a pilot test, the states used these standards to assess their retail programs. However, many states failed to adopt the standards because, if the assessment indicated that a program was

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.
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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 Manufactured 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, inspection, 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 support (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 Quarantine 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 standardization 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 Regulatory Program Standards, which leads the committee to conclude that the integration process is feasible (Solomon, 2009a). For other states, an infusion 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 professional expertise, training, and oversight; and to audit the inspections and

12

Personal communication, Marion Aller, Director of the Division of Food Safety, Florida Department of Agriculture and Consumer Services, April 20, 2009.

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.
×

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 auditing (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 committee 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 government 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 meaning 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 suggested 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.

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.
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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 inspections require internal auditing of inspectors by supervisors to ensure that appropriate inspectional methods are being used. Also, like federal inspectors, 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 standardization, 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 committee recommends a review and update of the inspectional procedures and training curricula for both federal and state inspections and the standardization 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 qualitative 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 implementation 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.

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.
×

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 integration 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 moving 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 relatively short period of time. The committee recognizes that questions of legal authority regarding the roles of the states, CDC, and the FDA in the investigation 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

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.
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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, inspection, 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 harmonize their programs by providing adequate standards and overseeing their implementation, beginning with those states that meet such standards. Standardization and integration of state and local food safety programs should be conducted in an evolutionary fashion, with intermediate 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 nationwide 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 recommendations 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 formal 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.

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.
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The responsibilities of the states should include the following:

  • The states should cooperate with the FDA in standardization processes 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 setting, 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 conduct 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 processing areas.

  • As recommended in Chapter 8, after review by an independent body, the FDA’s inspection procedures should be revised to promote 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 appropriately ISO 17025–certified state food laboratories. For those states not yet ISO-certified, the FDA should work, and assist with funding if necessary, to facilitate ISO 17025 certification over the next 10 years.

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.
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  • 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 philosophical change.

  • The FDA should identify intermediate goals with associated performance 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 Survey. York, PA: AFDO.

AFDO. 2009a. State Food Safety Resource Survey. York, PA: AFDO.

AFDO. 2009b. AFDO Food Laboratory Standard Methods Accreditation Survey. 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.

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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.
×

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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.
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Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems.

Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more.

Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

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