• Executive Summary
• Introduction
• NAS Recommendation I
• Council Assessment
• Scientific Challenges
• NAS Recommendation IIa
• Council Assessment
• Current Legislative Challenges
• NAS Recommendation IIb
• Council Assessment
• Challenges in Planning
• NAS Recommendation IIIa
• Council Assessment
• Factors to Consider in Organizational Restructuring
• NAS Recommendation IIIb
• Council Assessment
• Challenges to Developing a National Food Safety System

Executive Summary

Americans have one of the world's safest food supplies. This is largely a result of sustained regulatory and education programs along the farm to table continuum as well as surveillance and research efforts. The federal food safety system, comprised of multiple agencies, is authorized by a diverse set of statutes and is supported by numerous key partnerships with state, local, and tribal governments. Together these agencies have created a system that has given U.S. consumers confidence in the safety of their food purchases.

As good as the nation's food safety system is, there is room for improvement. Illnesses and deaths due to contaminated food, while preventable, continue to cause considerable human suffering and economic loss. That is why, at the very beginning of his first term, President Clinton set a course to strengthen the nation's food safety system. Under the President's leadership, surveillance and research have dramatically increased, programs are better coordinated, and regulations are more prevention-oriented and science-based. But this is only the beginning. The Council on Food Safety, with the help of the public, will continue to identify problems and promote solutions.

The Council welcomes the findings and recommendations provided by the National Academy of Sciences in its August 1998 report Ensuring Safe Food From Production to Consumption. This report lays out a clear rationale for a national food safety plan, one that is based on science and risk assessment.
 
 

At the request of Congress, the National Academy of Sciences (NAS) conducted a study of the current food safety system to: (1) determine the scientific basis of an effective food safety system; (2) assess the effectiveness of the current system; (3) identify scientific and organizational needs and gaps at the federal level; and (4) provide recommendations on scientific and organizational changes needed to ensure an effective food safety system. To conduct this study, the NAS established a committee and obtained input from federal agencies and other stakeholders of the federal food safety system. The NAS issued its report on August 20, 1998.

On August 25, 1998, through Executive Order 13100, the President established the Council on Food Safety and charged it to develop a comprehensive strategic plan for federal food safety activities and to make recommendations to the President on how to implement the plan. Also on August 25, 1998, the President directed the Council to provide him with an assessment of the NAS report in 180 days. Specifically, the President directed:

In general, the Council finds the NAS report a constructive contribution to efforts to improve the effectiveness of the federal food safety system through strengthening science and risk assessment, strategic planning, and better federal integration with state and local governments. In particular, the NAS places appropriate weight throughout its report on applying science to the management of government food safety efforts. Science must be advanced within the context of these competing interests. The NAS report recommends that priorities of the nation's food safety system should be based on risk. The Council agrees with the report's thesis that a food safety system that includes regulation, research and development, education, inspection and enforcement, and surveillance should be based on science and should use various risk analyses including quantitative and qualitative risk assessments and risk management principles to achieve such a system.

The Council recognizes that a food safety system comprised of multiple agencies with differing missions and statutory authority may increase the potential for uneven adoption and inconsistent application of science-based regulatory philosophies. While different applications may provide useful information to policy makers relative to the effectiveness of various approaches, the Council's strategic plan (including its assessment of existing statutes and structures) will result in more consistent regulatory measures and philosophies. The Council is committed to identifying further improvements that would result in a seamless, science-based food safety system.
 

The NAS report recognizes that the United States has enjoyed notable successes in improving food safety and that with increasing knowledge, many rational, science-based regulatory philosophies have been adopted. The report suggests, however, that adoption of these regulatory philosophies has been uneven given the fragmentation of food safety activities, and the differing missions of the various agencies responsible for specific components of food safety. The greatest strides in ensuring future food safety from production to consumption, the NAS argued, can be made through a scientific, risk-based system that ensures surveillance, regulatory, research, and educational resources are allocated to maximize effectiveness.

Council Assessment

The Council strongly endorses this recommendation. Many federal food safety programs are already, or are being modified to be, science-based. The Council recognizes that scientifically robust programs will result in better identification of public health needs, and determination of the most effective means of reducing public health risk, including the most cost-effective opportunities for improvement, and improved priority setting.

The scientific information generated through surveillance, research, and risk assessment efforts will result in improved food safety only if there is a commensurate strong effort to translate that scientific information into practical, usable information at the working level, e.g., through guidance or education. This means there must be education for all those involved in producing, manufacturing, transporting, and preparing food as well as for those persons involved in government food safety regulatory activities.

The Council's goal is to ensure that science- and risk-based decision making are central to the Administration's on-going efforts and its strategic plan. Considerable improvements have been made over the past several years. The strong scientific underpinnings of the President's Food Safety Initiative, enactment of the Food Quality Protection Act (FQPA), restructuring of food safety agencies within USDA, and many individual agency activities such as implementation of Hazard Analysis and Critical Control Points (HACCP) programs for meat, poultry, and seafood, have strengthened the overall science base of the food safety system.

The Council believes that the necessary elements of a science-based program—surveillance, outbreak response, risk assessment, research, regulation, inspection, and education—are largely in place, and that improvements planned for the next 5-10 years will enhance food safety significantly. The Council will consider in its strategic plan the following elements of a science-based food safety system:
 
 

Scientific Challenges

The Council faces a number of challenges in improving the scientific base of the food safety system. The following are a few examples of challenges that must be met to strengthen the scientific underpinnings of federal food safety efforts:

The NAS report identifies a need for a "national food law that is clear, rational, and comprehensive, as well as scientifically based on risk" as a major component of a model food safety system. The report concludes it is necessary to revise the current statutes on food safety to create a comprehensive national food law under which:

Council Assessment

The report's recommendation that federal statutes provide agencies with authority to make decisions based on scientific assessments of risks to the public health is sound. Decisions based on public health risk assessments allow agencies to make effective use of science to set food safety priorities, allocate resources to higher risk areas, and instill consumer confidence that high-risk hazards are being addressed.

Since the federal food safety regulatory agencies operate under very different legislative authorities, the Council will conduct a full assessment of these statutes and evaluate the degree of regulatory flexibility that already exists. The Council has decided that this legislative review will be undertaken as part of the strategic planning process. The purpose of the review will be to: 1) examine the similarities and differences in federal food safety statutes; 2) identify the "best" statutory approaches for reducing foodborne illness; and 3) assess both gaps and statutory barriers to implementation of the plan. The need for statutory changes could then be determined, and, if necessary, legislative principles developed which would form the basis for discussions with stakeholders and Congress. For example, given the recent overhaul of pesticide legislation, the Council believes that further statutory changes may not be needed for pesticides at this time.

In some cases, the NAS report misinterprets existing statutory requirements. For example, the report concludes that the statutes require the current method of organoleptic inspection of all carcasses. Even though the current law requires continuous inspection, it does not specify how this inspection mandate is to be carried out. The statutes do require appropriate inspection of animals prior to slaughter and inspection post-slaughter at all official slaughter and processing facilities. Among other significant food safety purposes, this continuous inspection requirement ensures use of the best sanitary dressing processes, prevention of fecal contamination, and prevention of meat from diseased animals from entering the food supply. Under the statutory flexibility that already exists, USDA has begun to develop and test a more risk-based inspection system, including adopting regulations requiring that HACCP be implemented in all slaughter and processing plants. In addition, USDA is studying how best to effect further improvements in the inspection of meat and poultry.

The food safety agencies have achieved and can continue to accomplish significant science-based improvements in their food safety programs under current authorities. However, new authorities that would improve the federal food safety system have been proposed by the President and are waiting action by Congress. Further analysis of the statutes may result in additional proposed statutory modifications.

Current Legislative Challenges

As part of its review of food safety statutes, the Council will focus on areas where regulatory jurisdiction is split between agencies and where resources could be more effectively shared between agencies. The Administration will work with Congress to pass:

This recommendation contains two parts. The first part recommends that Congress and the Administration require preparation of a comprehensive, national food safety plan. The NAS report lists several essential features of such a plan, including a unified food safety mission; integrated federal, state and local activities; adequate support for research and surveillance; and increased efforts to ensure the safety of imported foods. The second part of the recommendation stresses that resources should be allocated on the basis of science-based assessments of risk and potential benefits.

Council Assessment

The Council agrees that a comprehensive national food safety strategic plan should be developed and the development of such a plan is underway. In fact, the President's Food Safety Initiative was an initial step toward a national food safety plan. The 1997 Farm to Table report was a means of leveraging federal food safety resources through coordinated planning and cooperative work to meet common needs such as development of surveillance data, response to outbreaks, research into preventive interventions, development of risk assessment techniques particularly for microbial risk assessments, and consumer education. This initial plan also took some steps toward extending food safety planning to the state and local level.

Strategic Planning

Picking up where the Farm to Table report left off, the Council will continue and expand the strategic planning process. One of the Council's primary purposes is to develop a comprehensive strategic plan for federal food safety activities that contains specific recommendations on needed changes, including goals with measurable outcomes. The plan's principal goal is to enhance the safety of the nation's food supply and protect public health through a seamless science- and risk-based food safety system. The plan will set priorities, improve coordination and efficiency, identify gaps in the current system and mechanisms to fill those gaps, continue to enhance and strengthen prevention strategies, and develop performance measures to show progress.

Preparation of the food safety strategic plan will be a public process, and will consider both short- and long-term issues including new and emerging threats and the special needs of vulnerable populations such as children and the elderly. Once the plan is sufficiently complete, the Council will advise agencies of priorities for investing in food safety and ensure that federal agencies annually submit coordinated food safety budgets to OMB to sustain and strengthen existing capacities. In short, the President's Council on Food Safety will develop a national food safety plan and make budget recommendations to agencies and OMB to accomplish what the NAS report recommends.

The Council has defined the scope of future federal level food safety strategic planning and a process for interagency planning and public participation. An interagency task force anticipates having a draft plan ready for public review and discussion in January 2000. Even while developing this plan, the task force intends to continue its consultations with stakeholders. The following is the draft vision statement for the Council's strategic plan:

The Council's strategic planning task force is analyzing the transcripts of the 1998 public meetings and the input received through the notice and comment process to determine the major themes, issues, and subject areas. The task force will also consider the conclusions and recommendations of the NAS report, input from the federal, state, and local government integrated National Food Safety System Project, and input from the agencies involved.

The planning process will build upon common ground and provide the forum to tackle some of the difficult public health, resource, and management questions facing the federal food safety agencies and our state, tribal and local government partners. The plan will identify areas for enhanced coordination and efficiencies, determine whether legislative changes would be beneficial, and clarify federal, state, tribal, and local government roles and responsibilities in the national food safety system (see discussion under recommendation IIIb).

The strategic planning process will consider thoroughly the results of the legislative review outlined under the Council's assessment of NAS recommendation IIa. Examples of possible legislative proposals from such a review include:

The NAS report recommendation goes a step further than a national plan by urging that resources be allocated according to science-based assessments of risk and potential benefits. As stipulated in Executive Order 13100, the Council will ensure that agencies develop a coordinated food safety budget submission consistent with the strategic plan. The Council will develop guidance for food safety agencies to consider during the preparation of their individual budgets. The Council has created a budget task force that will:

An important part to both risk-based planning and resource allocation will be the development of a comprehensive comparative risk assessment of the food supply. The Council has requested the Interagency Food Safety Risk Assessment Consortium, which consists of HHS and USDA agencies and EPA, to consider how to develop a comparative risk analysis for food safety strategic planning. The Council will direct the Consortium to seek and consider public input in its analysis.

The Council believes that various steps may need to be taken to evaluate risks including: a ranking of foodborne pathogen risks based on surveillance and economic data; consideration of a broader range of food safety hazards including not only microbial risks, but also pesticides and chemicals; and finally, selection of highly ranked hazards, an evaluation of control measures, and an evaluation of net benefits. The Council must avoid applying risk assessment in a manner that is too strict, rigorous, or inflexible. Instead, the comparative risk assessment must be used to prioritize the known greatest risks at the current time, with the understanding that scientific risk estimates can, and will likely, change frequently over time.

Challenges in Planning

The Council faces the following challenges in developing a comprehensive food safety strategic plan and allocating resources based on risk:

The NAS report finds that the existing regulatory structure for food safety in the United States is not well equipped to meet current challenges. Specifically, it points out that the system is facing tremendous pressures with regard to:

The NAS report attributes the lack of adequate integration among federal, state and local food safety authorities in part to the absence of "focused leadership" that has the responsibility, the authority and the resources to address key food safety problems. The report presents several examples of possible organizational structures to create a single federal voice for food safety. These include:

Council Assessment

The Council agrees with the goal of the NAS recommendation--that there should be a fully integrated food safety system in the U.S. The food safety agencies are committed to this goal, and the Council is confident that its comprehensive strategic plan will be a major step toward creating a seamless food safety system. To ensure that the strategic plan achieves this goal, the Council will conduct an assessment of structural models and other mechanisms that could strengthen the federal food safety system through better coordination, planning, and resource allocation.

The Council's strategic plan will bring agreement on the vision, goals, and actions needed to enhance the safety of the nation's food supply and protect public health by reducing the annual incidence of acute and chronic foodborne illness. It will also clarify the roles and responsibilities of each food safety agency as well as their interactions with state, tribal, and local government partners.

While the Council recognizes that certain models of reorganization may improve coordination and allow for a better allocation of resources, any reorganization of food safety activities must consider the non-food-safety-related responsibilities of each agency and how these relate to the food safety responsibilities. Reorganization must not be done at the expense of these other responsibilities and activities. The Council is concerned that, if not done carefully, separating food safety from non-food safety activities in each agency could act to weaken consumer and environmental protection overall.

The Council also recognizes that expertise and knowledge, particularly expertise in state-of-the-art science and technology, provides a resource to food safety activities. For example, analytical methods for detection and quantification of adulterants in foods may be adapted to detection of chemical contaminants that threaten public health. Expertise in non-food safety regulatory science and legal procedures are critical when warnings are required on food labels to assure safety. In addition, reorganizations must avoid interfering with the public health framework established to identify and respond to infectious and non-infectious public health threats whether they are foodborne or not, since many of the major foodborne pathogens also produce non-foodborne disease. Thus, in its strategic planning the Council will be cognizant of the interplay between the food safety and non-food safety activities of each agency and how they affect each other.

The Council believes that there are programs that can benefit from immediate reorganization. For example, during the last two years, FDA and NOAA have been developing a proposal to transfer the NOAA Seafood Inspection Program to FDA as a Performance Based Organization (PBO) in order to operate the voluntary Seafood

Inspection Program on a more business-like basis. The PBO would be formed under the umbrella of FDA and would include all seafood inspection activities now carried out by NOAA. The fiscal year 2000 budget proposes to transfer the existing Seafood Inspection Program from NOAA to FDA. This action will fully consolidate federal seafood inspection activities within one agency thereby increasing the efficiency and effectiveness of seafood oversight. It will also enhance the overall safety and wholesomeness of seafood products. Funds are provided in the President's fiscal year 2000 budget to cover the costs of transition, including training and education activities.

Factors to Consider in Organizational Restructuring

The Council assessment of structural and organizational options must take into consideration factors such as:

The NAS report recommends that federal, state, and local governments function as an integrated enterprise, along with their partners in the private sector. The report identified five statutory tools required to integrate federal, state, and local food safety activities into an effective national system:

Council Assessment

The Council agrees that the roles of state, tribal, and local governments in the food safety system are critical and that their efforts deserve the formal recognition that partnership in a national food safety system conveys. Thus, the Council supports steps taken toward the development of a more fully integrated national food safety system. While more needs to be done to optimize and develop new partnerships, the federal food safety agencies have already established extensive interactions with state and local regulatory agencies. In fact, a critical factor for the Council to consider is the manner in which existing federal/state or local activities are integrated and coordinated. The Council believes that its strategic planning process provides a fresh opportunity for their non-federal partners to participate as primary and equal partners in the development of the future food safety system.

Some overlap occurs among federal, state, and local food safety efforts. Neither federal food safety agencies nor state and local agencies have sufficient resources to carry out a comprehensive food safety program, but all these agencies have expertise and resources that, when combined in an integrated program, would significantly enhance the impact of food safety programs.

The Council also agrees that the five statutory tools identified by the NAS are critical for ensuring good coordination between the federal government and state, tribal, and local agencies. Fortunately, the federal food safety regulatory agencies (FDA, FSIS, and EPA) already have most of the statutory tools recommended by NAS.

The Council recognizes and agrees with the report's conclusion that the lack of integration among federal, state, and local authorities often complicates the administration of regulatory programs. We need to utilize available mechanisms to leverage resources and expertise from government, industry, academia, and consumers to expand the nation's food safety capabilities beyond what any one group can accomplish. Increased awareness and knowledge of food safety in each segment of the food safety community should reduce the need for regulation of industry and decrease the incidence of contamination at every point in the food safety system in order to protect public health.

Integrated National Food Safety System (NFSS) Project

HHS, USDA, and EPA are working with state and local officials on an integrated National Food Safety System (NFSS) Project to identify appropriate roles and to develop mutually supporting common goals for all levels of government in the U.S. food safety system. This work is considered integral to the Council's strategic plan and coordinated budget recommendations and will be the basis for improved integration with state, tribal and local governments.

Under the leadership of the FDA, the Project is proceeding under existing federal, state, and local laws although all levels of government recognize that changes in some of the federal and state laws will be necessary to achieve an integrated system. The Project began with a meeting of state and local officials from public health and agriculture agencies and state laboratories representing all 50 states, Puerto Rico, and the District of Columbia, FDA, CDC, and FSIS in Kansas City in September 1998. In December 1998, six work groups and an 18 member Coordinating Committee composed of federal, state and local officials met in Baltimore, Maryland to begin to develop plans for implementing recommendations and overcoming the obstacles identified at the Kansas City meeting. Subsequent meetings will be held throughout 1999 to continue the planning process. The group estimates that a fully integrated federal/state/local food safety system will take up to10 years to build. The Association of Food and Drug Officials, which is an organization of state and local public health officials and regulators, strongly endorses the concept of a NFSS.

The NFSS Project builds on existing systems of federal/state cooperation such as the FSIS long-term "equal to" meat and poultry system currently operating in 26 states with shared state and federal funding and EPA's delegation to states of various regulatory programs.

Challenges to Developing a National Food Safety System

The Council recognizes that the existing systems for federal, state, and local government regulation of food and pesticides have different histories and important distinguishing characteristics. The Council believes it is important to respect the nature and strengths of the existing systems and that integration must proceed in a coordinated fashion. There are numerous challenges to building an integrated food safety system: