President's Council on Food Safety

U.S. Department of Agriculture	Department of Health and Human Services	Environmental Protection Agency	Department of Commerce

Food Safety Strategic Plan

Food Safety Strategic Plan

Executive Summary

Over the course of the past seven years the Clinton Administration has done much to help ensure that the United States has one of the safest food supplies in the world (appendix A). In just the last three years, there has been a 20% decrease in illnesses due to the major bacterial food pathogens across the United States. Despite this progress, however, foodborne illnesses continue to take a staggering toll on public health. Every year, millions of Americans become sick and many die from foodborne pathogens. The size of vulnerable populations (e.g., the elderly and those with compromised immune systems) is growing. The public has become increasingly aware and concerned about the health risks posed by both these pathogens and by potentially hazardous chemicals in food.

Changes in the ways that food is produced, distributed, and consumed present new challenges for ensuring the safety of our food. More of our food is grown abroad; many foods are transported long distances; and we eat away from home more frequently. Although these trends have clear benefits, each raises new challenges for maintaining the safety of our food supply.

At the direction of the President, the Council on Food Safety (appendix B) prepared this comprehensive strategic plan to build on the Administration's previous successful efforts. Chapter 1 contains background on the Plan's development, which was influenced greatly by previous analyses of the food safety system, such as the National Academy of Sciences (NAS) report Ensuring Safe Food from Production to Consumption, and by public comments obtained through a series of consultations and open meetings. The Council heard from all segments of the food safety system including various levels of government, industry, universities, consumer advocates, and the general public.

Chapter 2 of this report articulates the Plan's vision for food safety and public health, outlines its goals and objectives, and identifies needed actions for the next 5 years. The three goals of the Plan focus on risk assessment, risk management, and risk communication reflecting our risk-based approach to food safety oversight.

Chapters 3 and 4 contain discussions on the existing legislative framework and organizational structure for the Federal food safety system. The Council concluded that the nation's seven major food safety statutes provide adequate authority to carry out both our current programs and the new initiatives proposed in this Plan. However, changes in the Federal food safety laws could strengthen our ability to provide a higher level of public health protection from foodborne hazards and make existing programs more efficient and effective. Similarly, the Council found that while the existing organizational structure of the Federal system is currently protecting the public from foodborne illnesses, it introduces duplication, inspection and enforcement inefficiency, and non-risk based funding.

Recommendations (from Chapter 5):

• The Council recommends the development of near-term legislative proposals to strengthen the existing food safety statutes enabling stronger prevention, enforcement, and recordkeeping activities.
• The Council recommends near-term efforts to strengthen agency coordination to improve the efficiency and effectiveness of Federal food safety activities.
• The Council recommends the development of comprehensive, unifying legislation, followed by the development of a corresponding organizational reform plan that protects the public's health by allowing risk-based allocation of resources and utilization of science-based regulation, enforcement, and education. This comprehensive framework should address food safety standard setting, inspection, enforcement, research, and education.

While America's food supply is abundant and generally regarded as one of the world's safest, we must do more to make it even safer. This Plan provides a roadmap to do just that. To implement it, however, the Council will need to redouble its commitment and strengthen its partnerships with state, tribal, and local governments; industry; universities; and consumers. In addition, the Council will need to work with the Congress to ensure adequate resources are appropriated and those needed legislative proposals are advanced.

CHAPTER ONE:

Introduction

FOOD SAFETY: THE NATION'S CHALLENGE

Over the course of the past seven years the Clinton Administration has done much to help ensure that the United States has one of the safest food supplies in the world (appendix A). In just the last three years, there has been a 20% decrease in illnesses due to the major bacterial food pathogens across the United States. Despite this progress, however, foodborne illnesses continue to take a staggering toll on public health. Every year, millions of Americans become sick and many die from foodborne pathogens. Our vulnerable populations are growing, with increased longevity and increasing numbers of immune-compromised individuals. Now nearly a quarter of the population is at higher risk for foodborne illness. The public has become increasingly aware and concerned about the health risks posed by both these pathogens and by potentially hazardous chemicals in food.

Changes in the ways food is produced, distributed, and consumed present new challenges for ensuring the safety of our food.

• Americans are eating a greater variety of foods, particularly poultry, seafood and fresh fruits and vegetables. This is beneficial to our health, but presents new food safety challenges, as shifting dietary preferences may lead to different patterns of exposure to chemicals and pathogens.
• More consumers desire a wide variety of foods year round, making food safety issues surrounding transportation and refrigeration increasingly important.
• As international trade expands, shifting regional commerce and products to a global marketplace, we face the challenge of ensuring the safety of imported food.
• Americans are also eating more of their meals away from home. In fact, fifty cents of every food dollar is spent on food prepared outside the home. This food is purchased not only from grocery stores and restaurants, but also is consumed in institutional settings such as schools, hospitals, nursing homes, and day care centers. As a result, a comparatively few people are involved in preparing large numbers of meals for others, so the potential impact of disease-producing errors increases.

As food safety problems have arisen over the past century, the Federal government has responded in a variety of ways. Beginning early in the 1900s with the creation of the earliest regulatory programs to the creation of the President's Council on Food Safety in 1998, the Federal government, working in concert with its state, tribal, and local counterparts, has continuously endeavored to improve the safety of the American food supply (see appendix A for accomplishments during the Clinton Administration).

In addition to Federal efforts, our nation's food safety system is significantly affected by the work of state, tribal, and local public health, agriculture, and food regulatory officials. Individually and together they perform many different roles on the front lines for food safety. From initial recognition of outbreaks and their investigation, to laboratory work, to farm and retail oversight, to communications with the public, these officials and their representative groups and organizations are key participants in the national system.

Federal food safety officials, therefore, operate in a complex system of statutes, agencies, coordinating bodies, and interactions with state, tribal, and local governments; industry; and other stakeholders. The following list provides a summary of the major Federal food safety agencies and coordinating mechanisms:

Regulatory Agencies: At the Federal level, three agencies currently have major responsibilities for regulating food and substances that may become part of food:

• Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA) ensures the safety of all domestic and imported meat, poultry, and some egg products in interstate commerce except game meat.
• Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) has in its purview all domestic and imported foods that are marketed in interstate commerce (except for meat, poultry, and some egg products) as well as game meat, food additives, animal feed, and veterinary drugs.
• Environmental Protection Agency (EPA) licenses pesticide products and establishes maximum allowable limits (tolerances) for pesticide residues in food and animal feed. (FDA and FSIS enforce pesticide tolerances for the commodities under their jurisdiction.) In addition, EPA has regulatory and research programs related to water and foodborne toxic chemicals such as dioxin.

The three primary regulatory agencies are supported by a number of other government organizations:

• Centers for Disease Control and Prevention (CDC), in HHS leads Federal efforts to gather data on foodborne illnesses, investigate foodborne illnesses and outbreaks, and monitor the effectiveness of prevention and control efforts. CDC also plays an ongoing role in identifying prevention strategies and building state and local health department epidemiology, laboratory, and environmental health skills to support foodborne disease surveillance and outbreak response.
• USDA Agricultural Research Service (ARS), Cooperative State Research, Education and Extension Service (CSREES), and the Economic Research Service (ERS) conduct food safety research.
• Animal and Plant Health Inspection Service (APHIS) provides surveillance of zoonotic diseases, traces affected animals to herds of origin, and conducts risk assessments.
• National Marine Fisheries Service (NMFS) within the Department of Commerce conducts a voluntary seafood inspection and grading program to ensure the quality and safety of commercial seafood. (Mandatory regulation of seafood processing is under FDA's jurisdiction.)

Other Supporting Agencies:

• National Institutes of Health (NIH), which is part of HHS, play important roles in conducting food safety research.
• Agricultural Marketing Service (AMS) within USDA conducts voluntary dairy, poultry, fruit and vegetable inspection and grading programs to ensure the quality of commercial products in both the domestic and international marketplace.

Coordinating Organizations/Mechanisms: In the last several years the Federal food safety agencies formed a variety of groups to improve coordination among agencies and between the Federal government and other levels of government in key areas:

• President's Council on Food Safety (Council) created by Executive Order 13100 coordinates the efforts of the Executive Branch in ways that make the food supply safer. The Council's charge encompasses all aspects of Federal food safety programs.
• Joint Institute for Food Safety Research (JIFSR) was created at the direction of the President in 1998 to coordinate planning and priority setting for food safety research among all Federal agencies, enhance public/private sector partnerships with academia and industry, and foster effective translation of research results into practice along the farm-to-table continuum.
• Risk Assessment Consortium (RAC) is a broad-based group, consisting of Federal scientists from many agencies, charged with advancing the science of risk assessment by encouraging development of predictive models and other tools.
• Foodborne Outbreak Response Coordinating Group (FORC-G), a partnership of Federal and state agencies, is designed to improve the approach to interstate outbreaks of foodborne illness and to develop a national, coordinated outbreak response system.
• Joint Institute for Food Safety and Applied Nutrition (JIFSAN) is a multidisciplinary research and education program established in 1996 by the Food and Drug Administration and the University of Maryland. It includes research and outreach components and combines resources from FDA and public and private partnerships to provide the scientific basis for ensuring a safe, wholesome food supply.
• National Food Safety System (NFSS) project was initiated in 1998 and is designed to forge closer working relations between the Federal government and state and local food protection agencies. The NFSS currently has five workgroups to generate ideas for activities to promote a more integrated national food safety system.

Due, in part, to the complexity of the food safety system and the fact that millions of Americans continue to suffer annually from foodborne illnesses, numerous calls have been made to examine the existing system and modify it to improve the protection of the public's health through enhanced efficiency, better coordination, and more risk-based allocation of resources. One of the most recent calls has been from the National Academy of Sciences (NAS). At the direction of Congress, the NAS conducted a study of the current system and issued its report Ensuring Safe Food from Production to Consumption⁽¹⁾ in August 1998. This report recommended that a comprehensive, national food safety strategic plan be developed. The NAS listed 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.

DEVELOPING THE FEDERAL FOOD SAFETY STRATEGIC PLAN

As part of the Administration's continuing efforts to improve the safety of the nation's food supply and building on the recommendations of the NAS report, the President issued Executive Order 13100 creating the "President's Council on Food Safety" (Council). The Council's goal is to make the food supply safer through a seamless, science-based food safety system supported by well-coordinated research, surveillance, sound risk assessment, regulation, enforcement, and education. The President specifically instructed the Council to develop a comprehensive 5-year Federal food safety strategic plan to improve the current system and to anticipate future needs. To address the President's directive, the Council established its Strategic Planning Task Force (appendix B).

In the Fall of 1998, the Council held a series of meetings to obtain the public's views on a long-term vision for food safety in the United States, to identify the important food safety challenges for the Plan, and to solicit public comment on the NAS report. Based on these meetings, the Strategic Planning Task Force developed draft goals and objectives, which were the basis for a public meeting in July 1999, and for discussions with stakeholders at scientific and professional meetings during subsequent months. In the fall of 1999, Task Force interagency working groups revised the draft Plan based upon comments from stakeholders. In January 2000, the Task Force engaged interested stakeholders in a discussion of the revised goals, objectives, and action items.

From the outset, the overarching goal has been to protect public health by reducing foodborne hazards. Thus, a Plan has been developed that helps set priorities; improves coordination and efficiency; identifies gaps in the current system and ways to fill those gaps; enhances and strengthens prevention and intervention strategies; and identifies reliable measures to indicate progress. Consistent with the NAS recommendations, the Plan calls for food safety priorities to be based on risk and aims to create an integrated seamless food safety system.

In response to the NAS report and many public comments, the Council's Task Force also examined the legal authorities under which Federal food safety programs operate and the organizational structure within which they are carried out.

GUIDING THEMES

Several inter-related themes guided the development of the plan. First and foremost among these is the recognition that the success of the plan must be evaluated on the basis of improvements in public health.

Second, consistent with NAS recommendations, the Council recognized that "the food safety system must rest on sound science." A critical dimension of each of the Plan's goals is to collect, analyze, disseminate, and fully use objective, scientific information about the nature and extent of food safety hazards and the means of preventing them.

Third, the Council recognized that assessment of food safety risks must play a critical role in setting priorities and determining the most effective use of our resources. Priorities must be based on where the scientific data show the greatest food safety risks. Risk-based priority setting will continue to be the most defensible way to shape budget choices, research agendas, risk management targets—indeed to guide every aspect of the effort to strengthen food safety programs.

The fourth theme shaping the Plan is that proactive strategies to prevent food safety problems are more effective than strategies that respond to food safety problems as they occur. Decades of experience have taught that it is more effective, and less expensive, to prevent food safety problems before they occur than to respond to outbreaks after they have happened. By swiftly applying a science-based understanding of the causes of foodborne hazards, government can encourage and direct the adoption of practices that will prevent harm, rather than responding only after people become ill as a result of something they ate.

The fifth theme focuses on the regulatory approaches used to protect the food supply. Government at all levels has a role in oversight of regulated industries and the enforcement of laws and regulations. Federal agencies and our state, local, and tribal counterparts must work together more closely to assure comprehensive and efficient regulation of the food industry and to create an integrated, seamless food safety system that protects the U.S. consumer. Responsible government oversight has to be a key element of any plan to prevent foodborne illnesses and hazards.

Finally, the Plan recognizes that increased coordination and action by all stakeholders is essential to the Plan's success. Given the breadth of the farm-to-table continuum—from hundreds of thousands of farms and processors, to millions of restaurants and supermarkets, to tens of millions of homes—assuring the safety of the nation's food supply is a shared responsibility. Partnerships among Federal, state, tribal, and local governments, as well as governments of other countries, academia, and the private sector are vital to the success of the Plan. And, action by industry, food handlers, health professionals and consumers—by everyone in the farm-to-table chain—is needed to reduce risk and ensure the safety of our food supply.

CHAPTER TWO:

Vision, Goals, Objectives, and Action Items

The Council developed the following vision, goals, objectives and action items to guide its actions over the next 5 years and to assure public health protection and the safety of the food supply for the American people.

Vision Statement

Consumers can be confident that food is safe.

We protect public health through a seamless food safety system that uses farm-to-table preventive strategies and integrates research, surveillance, inspection, enforcement, and education. We use science- and risk-based approaches and work with public and private partners. We are vigilant to new and emergent threats and consider the needs of vulnerable populations. Food is safe because everyone understands and fulfills their responsibilities.

Overarching Goal

To protect public health by significantly reducing the prevalence of foodborne hazards, thereby reducing acute and chronic illnesses and injuries through science-based and coordinated regulation, inspection, enforcement, research, and education programs.

Performance Measures

Creating meaningful performance measures is important for the overall Plan and very challenging. The ultimate aim of all the efforts described in the Plan is to improve public health significantly by controlling the risks of microbial pathogens, pesticides, chemical contaminants, and physical hazards in the food supply. Thus, where possible, the Plan specifies direct measures of public health, such as the incidence of specific illnesses, to assess how well the government's food safety programs are working. But, in some areas the scientific community has an incomplete understanding of the causes of illness or a limited ability to measure changes in public health resulting from regulatory oversight of the food supply. This is particularly challenging in addressing risks that may be caused by long term, low-level exposure to chemicals or pathogens. Thus, for some areas, measures are expressed in terms of changed behavior, such as the adoption of safe food handling practices, which is linked to improved public health. In other areas, the performance measures reflect changes in environmental exposure to hazards, such as residues of toxic pesticides in food, which serve as indirect proxies for improved public health.

The Plan must be implemented in a way that does not discriminate based on race, color, national origin, gender, religion, age, disability, sexual orientation, or marital or family status. The plan must provide effective outreach programs for risk communication for socially disadvantaged customers or consumers.

The public health targets include, by 2005, a 25% decline in the incidence of illnesses from the most common forms of foodborne pathogenic bacteria. The Plan also sets specific targets for preventing increases in antimicrobial resistance, improving food safety practices, and using safer pesticides. The quantitative targets are taken from the ambitious goals set in Healthy People 2010, subsequent Presidential initiatives, and each agency's Government Performance and Results Act (GPRA) plans. These measures for judging the Plan's impact are shown in Table I.

The Plan must constantly evolve as scientific knowledge grows. New scientific insights may well lead to different priorities or even better measures of the government's performance under the Plan. The Council should revisit and revise these measures, as appropriate, after FY 2001.

GOAL 1: SCIENCE AND RISK ASSESSMENT
The United States food safety system is based on sound science and risk assessment.

Every aspect of our strategy to improve food safety must be science-based. This principle is consistent not only with the recommendations of the 1998 NAS Report, but also with the Council's own assessments that make clear the need to strengthen our scientific understanding of food safety. For example, focused new research and better scientific methods are needed to answer such crucial questions as:

• Which food safety problems pose the greatest risks to public health and thus, need greater attention?
• What new tools could reduce or eliminate food hazards?
• How can the causes of food safety problems be quickly detected and uncovered?
• What is the full cost to society from microbial pathogens and chemicals in our food supply?

The five objectives below, as well as their associated individual action items, reflect the view that significant progress can be made through the thoughtful application of scientific resources to the right problems. Thus, the Plan calls for a variety of efforts to gather the basic information about pathogens and chemicals that will enable effective regulation and risk management, to bring greater coordination to our research so that we avoid duplication and stimulate creative problem solving, and to set risk-based priorities so that we achieve the most public health protection as efficiently as possible. To continue making progress, our efforts over the next two years will focus particularly on the following four areas:

• enhancing the overall quality of the scientific foundation of our food safety programs and building risk assessment capabilities;
• improving the link between regulatory programs and scientific research;
• conducting assessments of critical public health and food safety risks; and
• understanding better the comparative risks of different foodborne hazards.

These four areas cut across many of the objectives identified under Goal 1. The Joint Institute for Food Safety Research (JIFSR) will play an important role in much of the work undertaken to accomplish Goal 1 by mobilizing resources and bringing them to bear where they are needed.

OBJECTIVE 1:
Strengthen the scientific basis for food safety policies and regulatory decisions through expanded research and rigorous assessments of risk.

Fundamental research into the causes of and factors contributing to foodborne hazards and greater scientific understanding will lead to better risk assessment, which in the long term, should guide all public health and regulatory decisions. Using current information, JIFSR will promote the setting of risk-based research priorities whether for better risk assessment tools (and data to use in them) or for ways to identify and prevent new threats to public health and the safety of food.

Action Items

To create prevention-based programs and proactively protect public health, the Federal government must continue to invest in methods to identify emerging and potential public health and food safety threats. Without the capacity to detect these threats, serious food-related public health problems may go unrecognized.

Action Items

With limited resources and time, the scientific community must prioritize its efforts to realize its fullest potential. The most significant food safety problems must be identified and addressed in a manner that enhances public health. Research must be focused and coordinated to avoid duplicative efforts and maximize its benefits.

Action Items

The Federal government aspires to bring the best possible science to food safety programs. Such world-class science is possible only with top quality scientists, the best equipment, and access to the most current information. The action items below focus on enhancing science at all levels, including the Federal government's, and on building strong, effective partnerships with health and food safety scientists in other levels of government, academia, and the private sector.

Action Items

Periodically, the government will need to determine whether these scientific research and risk assessment efforts have achieved public health goals. Such feedback is particularly critical for scientific research, and at a minimum, must include a robust scientific peer review process.

Action Items

GOAL 2: RISK MANAGEMENT
The United States system for managing food safety is effective from farm-to-table.

Delivering safe food to the dinner table is the culmination of the work of many people. Producers, shippers, processors, distributors, handlers, and numerous others perform actions every day that may affect the safety of our food. Everyone's challenge is to perform these individual actions as well as possible, so that the food Americans eat is free from physical hazards and dangerous levels of pathogenic microorganisms and hazardous chemicals.

Government at every level—Federal, state, tribal, and local—also plays an important role in managing foodborne risks. Through regulations, incentive programs, voluntary efforts, education and training, and compliance inspection and enforcement activities, government efforts shape the daily behavior of those who produce, process, transport, and prepare food. The government recognizes that there are many types of food, many steps along the way from farm to table, and many types of foodborne risks. Thus, flexibility is needed to apply resources most effectively in managing risk. The Objectives and Action Items below detail our overall strategy for government involvement in managing foodborne risks.

Since the Federal government cannot do everything at once, we have chosen to focus efforts in the near term on the following six areas, which cut across many of the objectives identified for Goal 2:

• enhancing response to emergencies,
• setting inspection priorities based on risk;
• improving import inspection activities;
• developing and strengthening standards;
• enhancing monitoring and surveillance; and
• accelerating technology development and implementation.

Achieving the objectives described below will require intensified effort on many fronts, along with substantial advances in communication and coordination. With the current food safety system, few objectives or action items can be carried out by a single Federal agency, and most cannot be done by the Federal government alone. A range of mechanisms for coordination is needed across agencies at the Federal level; between Federal, state, and local officials; and between the public and private sectors. Some steps have already been taken in this regard—for example, the interagency plan to improve egg safety. But much more is needed.

OBJECTIVE 1:
Identify areas where risk management gaps exist in the current food safety system

With many agencies involved in food safety regulation—not only at the Federal level, but also at the state, tribal, and local levels—there are bound to be different approaches, different coverage, and different standards. The Federal government, in partnership with state, tribal, and local governments, needs to examine this mosaic carefully to identify where gaps exist in public health protection and take steps to close them and, where inconsistencies exist, to harmonize the different approaches.

Action Items

OBJECTIVE 2:
Develop and implement preventive practices, techniques, and controls using risk-based approaches and establish national standards, including performance standards, where appropriate.

Prevention practices, including carefully tailored regulations, on the farm and throughout the production and distribution chain can play a critical role in minimizing risks from pathogens, pesticides and physical hazards. By implementing strategies on a nationwide basis, all participants in the food system can understand their roles and responsibilities. There are abundant examples of preventative strategies that have worked on a state or local level that could be expanded to the entire country. In a similar fashion, preventive approaches applied to one food or production process can be extended to other areas.

Action Items

OBJECTIVE 3:
Expand public health surveillance and data collection capabilities for adverse human health outcomes related to the food supply.

Disease surveillance sheds invaluable light on the extent of public health problems related to the food supply, as well as insights into the potential causes and means of preventing such risks. Thus, expanded public health surveillance programs directed at characterizing the impacts from pathogenic microorganisms and hazardous chemicals in food are vital to ensuring the safety of our food supply.

Action Items

OBJECTIVE 4:
Expand and enhance effective monitoring and surveys of the food supply for potential hazards in products and production/processing.

Monitoring the presence of hazardous chemicals and pathogenic microorganisms in food and characterizing different food production and processing practices are clearly necessary companion activities to disease surveillance. Combining these various types of data will provide the information from which scientists, regulators, and educators can fashion targeted strategies for mitigating foodborne risks.

Action Items

OBJECTIVE 5:
Identify food safety risks and violations of food safety standards through inspections and enforcement of food safety laws and established regulatory requirements.

Enforcement provides incentives for people to comply; and broad compliance with protective standards is the most direct way to make the food supply safer. Because compliance is most critical in activities where the potential risks are the highest, strategies for selection of inspection targets need to be risk-based. Enforcement is also important for another reason. While it is not possible to detect and punish every violator, forcing compliance and applying sanctions for violations where appropriate removes any economic advantage that non-compliers might have gained over those who play by the rules.

Action Items

OBJECTIVE 6:

Encourage the implementation of risk-based, voluntary preventive approaches for improving food safety, where appropriate, to complement regulatory programs.

Voluntary approaches can complement regulatory programs, particularly where government actions enhance existing incentives for individuals to adopt practices that increase food safety. Other approaches rely on the power of information to influence behavior. Such voluntary, prevention-oriented approaches will have a greater chance of success if they are promoted in partnership with the affected stakeholders.

Action Items

OBJECTIVE 7:
Promote the development and transfer of new technologies and approaches to prevent risk and improve food safety.

Some of the greatest advances in food safety have occurred when innovative technologies have given the food industry new ways to identify and control food risks. The government must continue to foster an environment that encourages the search for and introduction of new technology-based approaches for improving food safety.

Action Items

OBJECTIVE 8:
Identify and respond to food safety emergencies rapidly and effectively.

Food safety emergencies are difficult to identify, in part because critical information may be in many different hands, and no one person alone can easily recognize its significance. Enhanced detection and investigation capabilities and increased sharing of information offer the best prospect of identifying foodborne illness outbreaks as early as possible. Once identified, the many different government agencies with responsibility must act swiftly and in concert to locate and recall the food that caused the illnesses.

Action Items

OBJECTIVE 9:
Develop an improved system for assuring that foods intended for import into the United States are produced under food safety measures that the United States concludes meet or otherwise achieve the appropriate level of public protection specified by the United States.

As agricultural trade expands and an increasingly larger share of our food comes from other countries, the Federal government must continue to ensure the safety of imported food. In addition to port-of-entry enforcement, the Federal government must work through international organizations, on a bilateral basis with other governments, and through non-governmental groups not only to communicate our standards, but also to share our insights into ways to meet them.

Action Items

OBJECTIVE 10:
Evaluate management of food safety risks.

Principles of sound management always include a "check" step—an assessment of whether an action produced the intended result. These efforts to improve food safety and public health through regulatory and other interventions will include specific, ongoing evaluation components.

Action Items

GOAL 3: RISK COMMUNICATION
The United States food safety system openly and effectively provides information on food safety risks and education on how to control those risks for everyone from farm to table.

The premise that food will be safe when "everyone understands and fulfills their responsibilities" lies at the core of the Council's vision for the 21^st century. Food safety depends not only on sound science and risk assessment and aggressive risk management strategies, but also on a broad and effective risk communication effort. The farm to table preventive strategies featured in the Plan include critical communication components that stress timely development and dissemination of accurate information and effective training and education for everyone from the food producer to the consumer. In sum, information, training and education play a critical role in achieving the food safety vision.

The Strategic Plan ultimately will be judged by its impact on public health. Therefore, it is essential that the collection and analysis of research and risk assessment data be followed by the prompt dissemination and use of newly obtained scientific information about the nature and extent of food safety hazards. Increased access to information allows greater opportunity for its practical application to food safety in a variety of contexts. More importantly, increased information and knowledge helps prevent future risks. Effective communication can help create and enhance consumer food safety practices and provide skills and knowledge that public health professionals, retail workers, and Federal, state, tribal, and local regulators need. And, information and communication can often be done in partnership with other public and private sector organizations that have established links with diverse groups. Our strategy to enhance the risk communication efforts of the Federal government concentrates on two areas:

• promoting public and private partnerships with the myriad stakeholders interested in food safety to deliver needed information, education, and training; and
• developing a national information network that fully exploits the latest communication technologies.

By focusing on these two areas in the near term, each of the objectives identified under Goal three will be advanced.

Perhaps more than in any other area of food safety, risk communication is dependent on the concerted and coordinated action of multiple actors throughout the farm-to-table chain—Federal, state and local agencies; health professionals; schools and universities; producers, packers, transporters, and retailers; consumer groups; and, of course, consumers themselves. For this reason, much of our strategy depends on developing clear messages, fostering networks, harnessing information technology, and strengthening partnerships. While some important mechanisms are in place to help with this effort, much remains to be done.

OBJECTIVE 1:
Sustain public confidence through effective, open, transparent, and timely information exchange regarding food safety risks, prevention strategies and decision making.

Creating effective food safety policies and programs and building public confidence in the food safety system depend on accurate, timely exchange of information and ideas among the government and other stakeholders. It is also critical to ensure that all points of view are heard and considered as policies and programs are developed. Finally, government must explain its decisions clearly.

Action Items

OBJECTIVE 2:
Provide rapid access to information about food safety surveillance, hazards, outbreak actions, enforcement and other food safety emergency activities through active outreach efforts.

An effective food safety system needs the capacity to transmit information and adapt messages rapidly and to provide communication tools and training programs to the appropriate people and institutions to help prevent or minimize public health threats. Especially during emergencies, this flow of information must occur in an open, rapid way to ensure the public's trust in the food safety system.

Action Item

OBJECTIVE 3:
Develop state-of-the-art, science-based information, education and training programs for all persons along the farm-to-table chain—growers, producers, transporters, retailers, food handlers, culinary professionals, consumers, regulators, public health workers, school officials, and medical care providers—focused on prevention of foodborne illnesses and hazards.

A significant part of our vision is that everyone will understand and fulfill their responsibility to make the food supply safe. The action items below address parts of the food chain from farm to table in which education and training can have a major impact. They also reflect an intent to work in close partnership with representatives of those segments of the public most affected.

Action Items:

OBJECTIVE 4:
Monitor and evaluate information and education programs to maximize public health.

Decreases in the incidence of illness from foodborne hazards are the most appropriate measures of success. Research should help everyone understand better the causes of food safety problems, and regulation, education, and training should reduce risks by changing the way people behave. But, the government must also measure health outcomes so it can evaluate how well efforts are working.

Action Item

CHAPTER 3:

Strengthening Federal Food Safety Laws

BACKGROUND

Today seven statutes provide HHS, USDA, and EPA with the primary tools to regulate food safety:

• the Federal Food, Drug, and Cosmetic Act (FDCA);
• the Public Health Service Act (PHSA);
• the Federal Meat Inspection Act (FMIA);
• the Poultry Products Inspection Act (PPIA);
• the Egg Products Inspection Act (EPIA);
• the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and
• the Food Quality Protection Act (FQPA).

These statutes were enacted and amended over a span of 90 years, starting in 1906 and 1907 with the first Federal food safety statutes, the Food and Drugs Act and the Meat Inspection Act. From their inception, however, these laws focused on different areas of the food supply, and they take varying approaches to food safety.

The Meat Inspection Act and its successor, the FMIA, required continuous inspection of meat and meat food products, both ante- and post-mortem, to identify animal diseases. The Meat Inspection Act also created an inspection force, which is administered today by USDA's Food Safety and Inspection Service (FSIS). Over the years, FSIS was also given similar authority to oversee poultry and egg products inspection under the PPIA and EPIA. Under these laws, FSIS carries out its food safety activities and protects the public health by ensuring that meat, poultry, and egg products distributed to consumers are wholesome, not adulterated, and are properly marked, labeled, and packaged.

Under these statutes, FSIS is charged with preventing the preparation, distribution and shipment of adulterated meat, poultry, and egg products to consumers, and overseeing appropriate labeling and provision of other consumer information. Meat, poultry, and egg products are not to be sold or transported unless they bear the USDA mark of inspection – the signal that FSIS has, through premarket inspections, determined that a product is wholesome, and neither adulterated nor misbranded. The three statutes also require that any country wishing to export meat, poultry, or egg products to the U.S. maintain an inspection program that is equivalent to the U.S. inspection program. This equivalence requirement goes not just to a system of inspection, but also to the maintenance of that system and to the equivalence of the products that are produced within that system.

The Food and Drugs Act, as originally enacted, forbade adulteration and misbranding of foods in interstate commerce. Under this statute, the food industry is responsible for producing safe and wholesome food, with the government, in effect, policing the industry through marketplace surveillance rather than mandatory premarket inspection. In 1938, the FDCA was enacted. It added controls over food processing, but did not change the basic approach to food safety set out in the 1906 act. In the 1950s and early 1960s, HHS' Food and Drug Administration (FDA) was given additional authority over pesticides, contaminants, and food and color additives. Since then, with the exception of pesticides and dietary supplements, no fundamental changes have been made to the food safety provisions of the FDCA. Under the FDCA, FDA exercises jurisdiction over production, processing, packaging, storage, and holding of domestic and imported food except meat, poultry, and some egg products. FDA seeks under this authority to ensure that food products are safe, sanitary, nutritious, wholesome, and adequately labeled. FDA's jurisdiction also includes premarket approval and surveillance of new animal drugs, medicated feed, and all food additives (including coloring agents, preservatives, food packaging, and sanitizers) that can become part of food. FDA also has jurisdiction related to food safety under the PHSA, which gives FDA two valuable additional tools: very broad authority to adopt regulations to prevent the spread of communicable diseases, and the ability to both provide assistance to, and accept assistance from, state and local government counterparts in the regulation of communicable disease.⁽²⁾

The Environmental Protection Agency (EPA) also plays a role in food safety through its authorities to protect water and regulate pesticide products used in this country. EPA's regulation of pesticides under the FDCA and FIFRA has historically focused on determining whether a pesticide should be licensed for use on designated crops and establishing maximum allowable residue levels (so-called "tolerances") in/on food. This authority was further strengthened by the Food Quality Protection Act of 1996 (FQPA) which establishes a health-based standard for pesticide residues and mandates that EPA look, among other things, at aggregate exposure, cumulative risk, and the potential need for an additional safety factor to protect infants and children.

In March 1999, the President's Council on Food Safety determined that a review of existing law should be part of the strategic planning process. To conduct this review, an interagency team of experts examined the primary food safety statutes. This team examined each statute under ten cross-cutting issue areas they identified as critical to the effectiveness of food safety regulation (e.g., safety standards, preventive controls, remedial and enforcement authorities, information, and jurisdiction and flexibility). As they explored how the seven statutes approach similar aspects of food safety regulation, the interagency team assessed the statutes' strengths and weaknesses and looked at which statutory tools work well and which do not. The interagency team also examined whether there are any significant gaps in the authority of the Federal food safety regulatory agencies, either over different types of food or over the many different activities during production, distribution and consumption of food along the farm to table continuum. Finally, although state and local regulators play a critical role in ensuring the overall safety of the food supply, the team did not consider, except in a very general way, the legal authorities available to state and local governments.

The team determined that there are no critical gaps in jurisdiction: at least one Federal agency has some form of regulatory authority at each point in the farm-to-table continuum. The team also determined that existing laws give the Federal agencies an adequate foundation for implementation of the Strategic Plan. Nevertheless, noteworthy weaknesses exist. For example, FDA's lack of access to information from food establishments under FDCA undercuts the agency's efforts to conduct tracebacks and operate a risk-based inspection program. FSIS and FDA lack authority to recall dangerous food from the marketplace, and FDA's authority, which is derived from the PHSA, requires rulemaking and only applies to risks from communicable disease. FSIS and FDA lack authority to impose civil money penalties on producers and suppliers who violate the laws. Changes in the Federal food safety laws would strengthen our ability to provide a higher level of public health protection from foodborne hazards and make existing programs more efficient and effective.

Listed below are potential changes to existing food authorities. The agencies' experience from many years administering these laws teaches that some regulatory approaches work better than others, and that some allow more efficient regulation than others. Thus, in some cases, at least one of the three primary regulatory agencies – FSIS, FDA, or EPA – already has the authority in its existing law, and this authority could be extended to the other agencies or other products.

Moreover, food safety issues do not always follow neat bureaucratic lines, and as emerging problems are identified, needs and priorities will likely change. Thus, in addition to the suggestions below, Congress should consider new authorities to give the Federal food safety agencies greater flexibility to use their combined resources in the most efficient and effective manner (e.g., cross-utilization of inspectors). Legislative change may also be needed to complete streamlining where jurisdictional overlaps exist, e.g., for products that contain both meat and other foods.

STRONGER PREVENTION

The Strategic Plan stresses the importance of preventing food safety problems before they occur and taking swift action to prevent known problems from becoming worse. While all of the agencies can use existing authorities preventively, there are a variety of ways to strengthen the agencies' ability to act.

• Expand and strengthen FSIS's, EPA's, and FDA's authorities to adopt a broad range of preventive controls.

The most effective way to protect consumers from unsafe food is preventing unsafe conditions in the first place using processing standards, systems, and technologies to prevent or reduce unsafe conditions. However, some question whether existing food safety laws allow FSIS, EPA, and FDA to require these kinds of preventive controls. The agencies responsible for ensuring food safety need clear, strong authority to require preventive controls where they are needed to stop unsafe food from reaching consumers.

• Broaden FDA's inspection authority under the FDCA to include food production and distribution records bearing on whether food complies with the requirements of the FDCA.

Although FSIS has full access to these records, and FDA can inspect records for other products, FDA does not have this critical inspection authority for food. Without it, FDA cannot effectively ensure that all food establishments are complying with food safety requirements. Access would enable FDA to conduct more effective food safety inspections, tracebacks, outbreak investigations, and recalls.

• Authorize FDA and FSIS to order food recalls and stop sales for all food safety hazards when either agency has reason to believe that the food is unlawful or poses a threat to public health, and to order regulated entities to provide public notice to consumers about recalls.

Until FDA and FSIS have the authority to order mandatory recalls and stop sales at any point in the food production and distribution chain, establishments can refuse to comply or delay. This would strengthen the ability of FDA and FSIS to prevent unsafe food from reaching the consumers and ensure consumers have prompt notice of recalls.

• Authorize FDA and strengthen FSIS's authority to require regulated entities to notify the agency with jurisdiction of the identity and location of adulterated and misbranded food.

Industry may be aware of problems with food, but fail to notify FDA or FSIS. Notification to FDA or FSIS is necessary to limit distribution of all unsafe food and avoid human illness.

• Clarify the FDCA, FMIA, PPIA, and EPIA to make clear that FDA and FSIS can take action against a food when it has been tied to outbreaks of illness.

Emerging foodborne illnesses have outpaced our ability to develop test methods. The statutes could be clarified to ensure that FDA and FSIS can act against food that is making people sick, even when no test methods exist to find the substance in food (e.g., cyclospora).

• Clarify the FDCA, FMIA, PPIA, and EPIA to make it clear that food from animals treated with unapproved drugs for which no approved test methods exist is illegal.

Generally, test methods do not exist to find residues of unapproved, illegal animal drugs in food. This clarification would ensure that FDA and USDA can act against food produced with unapproved, illegal animal drugs when the agencies have evidence that shows that such drugs have been used.

• Streamline and modernize the tolerance-setting provisions for contaminants in the FDCA.

Tolerances can be a useful risk management tool. However, the FDCA's tolerance-setting provision requires lengthy, burdensome formal rulemaking (rather than informal rulemaking) and it may not apply to all food safety risks. The provision could be amended to make it more functional.

• Require that imported food under FDA's jurisdiction be prepared, packed, and held under a system or conditions, or subject to measures, that meet or otherwise achieve the U.S. level of food safety protection.

U.S. consumers increasingly rely on imports to satisfy their demand for fresh produce and other foods. Yet some of the countries that export food to the U.S. do not have strong food safety systems. Affirmative authority in the FDCA giving FDA the ability to stop imports from countries whose systems do not meet the U.S. level of food safety protection would give FDA additional authority to ensure the safety of imported food.

• Require importers to notify FDA in advance of food shipments.

FDA has no requirement for advance notice of import shipments and thus must decide whether to inspect, take samples, or refuse the product very quickly. Otherwise, the product may degrade. Advance notice would give FDA more time to gather information needed to make quick, but informed, decisions about imported food.

• Authorize EPA to require records and reports on use of pesticides.

EPA currently depends on a patchwork of data collected by grower organizations, private companies, states, and Federal agencies to characterize the thousands of use patterns involving pesticide application to agricultural crops. These data are critical for producing realistic estimates of the burden of pesticide residues in food and water and thus, for evaluating the risks of pesticides to public health. Giving EPA authority to require records and reports would enable EPA to get the data it needs to assess risks accurately, determine appropriate risk mitigation measures, and evaluate the impacts on risks of its regulatory actions.

• Reinforce FDA's authority to order manufacturers of approved animal drugs and food additives to provide additional safety data if significant safety questions develop after approval, and authorize FDA to obtain information from producers on contaminants in their products, and food processors to substantiate claims that processing technologies produce safer food.

FDA does not have complete authority to ensure the continued safety of additives and new animal drugs. FDA does not have authority to access industry data on contaminants or the effectiveness of processing technologies. This would enable FDA to address significant questions concerning the safety of chemicals and contaminants in food and the effectiveness of food safety processing technologies in a timely fashion.

EFFECTIVE ENFORCEMENT

Timely and balanced enforcement complements prevention programs and ensures that those who "do not play by the rules" gain no advantage over those who comply. But for enforcement to act as an effective deterrent and to preserve a level playing field, agencies must have genuinely effective enforcement powers. Several possible changes discussed below would allow the Federal food safety agencies to detect violations more easily and to apply meaningful sanctions. These changes will also make sure that all the food safety agencies have similar enforcement tools to apply in similar situations.

• Authorize FDA and FSIS to impose civil money penalties for violations of food safety laws and increase the maximum amount of EPA's civil penalties under FIFRA.

Although EPA has civil money penalty authority for violations of FIFRA and FDA has civil money penalty authority for violations of the pesticide residue provisions of the FDCA, otherwise FDA and FSIS are limited to seeking penalties through criminal actions in the Federal courts. Civil money penalty authority would improve food safety by giving the agencies a timely and effective remedy against those who violate food safety laws.

• Amend the FDCA to authorize FDA to detain food, pending filing of judicial seizure action, when FDA has a reason to believe such food is adulterated or misbranded.

Currently, food can be distributed while a judicial seizure action is being prepared and filed. This would give FDA the same authority as FSIS to ensure that unsafe food may not be distributed while FDA is preparing an enforcement action.

• Remove the exemption from enforcement under the FDCA for transporters.

Currently, FDA has limited ability under the FDCA to enforce food safety requirements against transporters even though conditions during transportation, such as temperature, can be critical to food safety. This would ensure that FDA, like FSIS, can hold transporters responsible for food safety.

• Require importers of food subject to FDA jurisdiction to submit an affirmation of compliance with U.S. food safety requirements and authorize civil and criminal penalties for filing false information.

With the increasing number of food imports, it is critical that importers understand their responsibilities under the FDCA to ensure the food they bring into the U.S. is safe. Requiring importers to submit an affirmation of compliance would improve food safety by making their food safety responsibilities explicit and giving FDA additional and effective remedies against importers who violate food safety laws.

• Provide for debarment by FDA of persons who have committed certain offenses from importing food into the U.S.

Importers with bad food safety records often hide from FDA by doing business under different names or changing location. Debarment authority would allow FDA to stop individual importers with bad food safety records from continuing to import food.

INFORMATION

When statutory access to food safety information is lacking, agencies have to use scarce resources to develop data or depend on industry to provide information voluntarily. For example, food establishments under FDA's jurisdiction are not required to register by the FDCA or provide FDA with information about the kinds of food they produce. Yet this information is critical for FDA to effectively allocate inspection and sampling resources based on risk. Moreover, the Federal agencies' ability to enhance prevention by improving tracebacks, outbreak investigations, and surveillance and monitoring of food safety hazards could be vastly improved.

• Amend the FDCA to authorize registration and general product listing by FDA of food establishments.

Although meat and poultry establishments must register with FSIS, and drug and device establishments must register and list products with FDA, under the FDCA, food establishments are not required to register with FDA. Registration and general product listing would significantly improve FDA's ability to identify all food establishments, to allocate inspection and sampling resources based on risk, and to conduct more effective tracebacks, outbreak investigations, and recalls.

• Amend the FDCA to give FDA clear authority to require food establishments to keep food production and distribution records related to food safety.

Although FSIS has clear, comprehensive food safety recordkeeping authority, under the FDCA, FDA does not. Thus, FDA does not have the means to verify that all food establishments are complying with food safety requirements. Production and distribution records are also critical for effective tracebacks, outbreak investigations, and recalls.

• Amend the FDCA to authorize FDA to require that all food products be labeled with or accompanied by information that identifies its production and/or manufacturing location(s).

Currently, FDA does not have clear authority under the FDCA to require that production information travel with food. Without this information, determining the source when food safety problems occur can be difficult and take far too long. In the meantime, other unsafe food may be distributed because it cannot be identified. This information would help FDA conduct more effective tracebacks, outbreak investigations, and recalls.

• Amend the FDCA to remove the statutory barrier to sharing trade secret information that is related to food safety with other Federal and state entities.

The FDCA prohibits FDA from sharing certain kinds of trade secret information with other Federal and state agencies, no matter how crucial the information is to food safety. This would ensure that all agencies can use the most current food safety information in decision-making.

NEED FOR COMPREHENSIVE LEGISLATIVE REFORM

The options mentioned above are designed to improve the current system of oversight. However, based on our analysis, the Council has determined that to truly optimize the protection of the public's health from foodborne illnesses, unified, comprehensive legislation should be developed to provide a risk-based, prevention-oriented system for all food. Such a statute should allow for the assessment of risks associated with foods, establishment and use of science-based preventive controls, allocation of resources based on risk, use of modern enforcement tools, and measurement of results. Such an approach should not weaken any of the existing statutory authorities, but rather should increase flexibility and strengthen public health protection consistent with the recommendations.

CHAPTER 4:

Enhancing the System's Structure

The NAS report Ensuring Safe Food from Production to Consumption recommended that Congress "establish, by statute, a unified and central framework for managing Federal food safety programs, one that is headed by a single official and which has the responsibility and control of resources for all Federal food safety activities." The report acknowledges that there may be many organizational approaches for implementing the "single voice" concept, and recommended further analysis. Over the years, other organizations also have called for restructuring the Federal food safety system, while still others point out the disadvantages of major restructuring. In general, advocates of restructuring see it as a means to improve the efficiency and effectiveness of the system as well as to establish a more risk-based approach to the allocation of resources. Opponents of restructuring view it as potentially damaging to a system that already has a good track record of public health protection.

To address this issue, an interagency team identified evaluation criteria and examined a broad range of organizational options. Comments were solicited from the public on the range of options and the evaluation criteria, and were considered in the analysis. Based on this analysis and other inputs, the Council considered whether existing Federal structures and approaches need to be refined, strengthened, or changed. This chapter summarizes the Council's analysis and recommendations for enhancing the existing Federal food safety system.

There are a large number of variables to be considered in examining organizational structures for the Federal food safety system. These include:

• the numerous agency functions (e.g., research, surveillance, standard setting, inspection) and the interdependence of food safety and non-food safety functions;
• the breadth and depth of the farm-to-table production system that brings food to the American consumer;
• the different types of food (e.g., meat, fruits and vegetables, beverages);
• the multiple hazards that can be present in food (e.g., pathogens, chemicals, pesticides, physical hazards);
• the differing approaches to achieving food safety (e.g., prevention, pre-market review, post-market surveillance, risk-based inspection);
• the various departments/agencies which make up the current U.S. food safety system and their statutes (e.g., FMIA, FFDCA, FQPA); and
• the different mechanisms available for creating a seamless food safety system (e.g., stronger executive leadership, facilitating mechanisms such as Memoranda of Understanding and partnerships, and reorganization including a single food agency).

EVALUATION CRITERIA

In conducting the review, organizational options were examined by the interagency team based on the attributes of a desirable food safety system. One key evaluation criterion was an option's ability to facilitate implementation of the Plan's strategic goals. Additionally, the team's evaluation criteria reflected the view that the Federal food safety system must be: effective, efficient, science-based with a strong emphasis on risk analysis, comprehensive, and must instill public confidence.

Implementation considerations with both long- and short-term consequences were also weighed, including long- and short-term costs to full implementation; short-term disruptions and lapses in efficiency; the potential for short-run adverse impacts on public health; the impact on state, tribal and local food safety agencies; and the implications for relationships with critical stakeholders (e.g., Congress, other Federal agencies, international organizations, industry, consumer groups, affiliated associations, etc.).

ORGANIZATIONAL OPTIONS

A broad range of organizational options was examined. The options were based on the NAS report, legislative proposals over the last few years, food safety consolidation efforts in other countries, General Accounting Office (GAO) and Congressional Research Service (CRS) reports, public comments and testimony, and other resources.

The team considered four major options, and a variety of sub-options, encompassing the major regulatory responsibilities for food safety, and in some cases food safety research and foodborne illness surveillance funded by the U.S. government. The major options represent a continuum from strengthening the current system, to designating a lead agency, to creating a consolidated agency for most or all food safety functions.

In addition to these organizational options, the Council assumed that agencies would continue to streamline or consolidate existing regulatory programs. The Council has already proposed streamlining the agencies' approach to the oversight of egg safety. Similar efforts will be pursued in other areas where there is overlapping jurisdiction or where improvements in public health protection can be made.

The options analyzed include the following:

1. Coordinated Federal Food Safety System -- Utilize the existing organizational structure, but provide a coordination mechanism to create centralized, executive leadership.

2. Lead Agency Approach -- Provide centralized executive leadership and a "single voice" either through a lead agency or separate agencies with discrete responsibilities.
3. Consolidated Agency within Existing Organization -- Consolidate food safety regulatory and some related functions in one agency reporting to either a current Cabinet Secretary, or the management of an existing independent agency.
4. Stand-Alone Food Safety Agency -- Create a new, stand-alone food safety agency to facilitate achievement of food safety and public health goals.

SUMMARY OF KEY FINDINGS

Several key findings of the analysis influenced the Council's decisions. These findings were:

• The existing organizational structure:
  • reflects statutory mandates that have evolved over the past 100 years;
  • allows for a greater diversity of agency input into food safety problems;
  • reduces the ability to allocate resources based on risk;
  • impedes coordination of food safety efforts targeted to certain types of foods, technologies, or consumers; and
• Reorganization, by itself, will not significantly change the food safety system's capability to assure public health protection. Reform of the existing statutes and implementation of the Plan, which focuses on utilization of science and risk assessment, risk management, and risk communication are the key to improving public health protection.
• The Plan can be successfully implemented under any organizational option.
• No single structure for the food safety system provides the perfect solution.
• Although certain elements of the Plan may be facilitated by one or more of the organization structures, many potential changes will also create difficulties elsewhere in the Plan. For example, if only regulatory functions are consolidated, such a consolidation may not facilitate targeting these resources to the highest risks, and would divorce the regulators from the researchers.
• Options I through IV are progressively more likely to be costly and disruptive in the short term, but potentially more efficient in the long-term. Potential improvements in efficiency and efficacy need to be weighed against the costs, disruptions, and other effects experienced during reorganization and implementation.
• Attempts to coordinate within existing or slightly modified structures (Options I and II) may lead to marginal improvements but do little to address the fragmentation of the food safety system, and fail to eliminate duplication and conflict inherent in the current system.
• Consolidation (Options III and IV) could eliminate duplication and fragmentation, create a centralized leadership and single voice for food safety, clarify lines of authority, facilitate priority setting and resource allocation based on risk, and provide greater accountability.
• Consolidation (Options III and IV), coupled with statutory reform, could take many forms. Determining what responsibilities to include or not include is critical to maximizing efficiency and effectiveness of the federal food safety system. For example, separating food safety surveillance from other types of public health surveillance could be inefficient and detrimental to both. Similarly, separating research from food safety regulation could make research agencies less responsive to regulatory needs.
• A stand-alone agency (Option IV) focused on food safety and public health eliminates any perception of inherent bias or competing missions.
• A stand-alone agency might create new problems and inefficiencies in the oversight of dietary supplements and other food-related issues not included in the new agency.

CHANGES NEEDED TO STRENGTHEN THE FEDERAL SYSTEM

After weighing the pros and cons of each organizational option, the Council recommends several changes to strengthen the Federal food safety system. Specifically, the Council recommends continuing the coordination effort of the Council to: 1) implement this Plan, including the risk analyses needed to support decisions about organizational and statutory reform; 2) streamline or rationalize the existing food safety system especially in areas where there is overlapping jurisdiction (e.g., processed foods with meat, game meats, eggs, seafood); and 3) develop an organizational plan that addresses food safety functions consistent with the comprehensive, unifying statute recommended in chapter 3.

This three pronged approach will allow the Federal food safety system to advance in the near term by implementing the Council's Plan and fixing some of the more confusing and inefficient jurisdictional splits that detract from our overarching goal of significantly reducing food safety hazards to improve public health. However, the Council believes that in the long run it is in the best interest of the American consumer to have a comprehensive food safety statute with a corresponding organizational structure that allows for modern science-based regulatory programs, risk-based allocation of resources, and more effective inspection, enforcement, recall, and education programs.

CHAPTER 5

Conclusions and Recommendations

This plan provides a roadmap for the Federal food safety system. The Council has concluded that although the current system is providing a high level of public health protection from foodborne hazards, there is much room for improvement. In spite of the commitment and dedication to reduce the threat of foodborne illnesses by government, industry, and consumers, far too many of our citizens still suffer—millions become ill and thousands die annually from contaminated food.

In developing this Plan, the Council analyzed all aspects of the current system, including statutes and regulations, organizational considerations, public health goals, trends in industry and eating habits, current research, interactions with state, local, and tribal agencies, and available financial resources. The Council had the benefit of excellent input from all stakeholder groups.

CONCLUSIONS

The Council concludes that:

• the current Federal food safety system is providing a high level of public health protection, but it can be strengthened;
• surveillance, research, education, inspection, and enforcement are improving as a result of the President's Food Safety Initiative;
• within the existing framework of statutes and implementing organizations, significant further improvements can be made by strengthening our reliance on science and risk assessment, by expanding the use of preventive controls and other risk management practices, and by better communicating to the public and all those working within the food system;
• current food safety statutes have significant weaknesses and should be strengthened to provide new or expanded authorities;
• the current organizational structure makes it more difficult to achieve future improvements in efficiency, efficacy, and allocation of resources based on risk; and
• agencies will need to critically evaluate all available food safety resources and deploy them based on risk within existing statutory constraints.

IMPLEMENTATION OF THE PLAN'S ACTION ITEMS

The goals, objectives, and action items contained in this Plan, which are intended as a guide for Federal agencies over the next five years, will be implemented as follows:

• Where action items are to be accomplished by a single agency, that agency will be responsible for implementation, planning, resources, and communication regarding the program.
• In some cases, coordinating mechanisms exist for actions that require cross-agency collaboration (e.g., JIFSR and FORCG). In other cases, the Council may need to establish additional coordinating mechanisms to bring appropriate agencies together to determine planning steps, level of involvement by participating agencies, and a timeline and resources for completion.

RECOMMENDATIONS

The Council recommends:

• the development of near-term legislative proposals to strengthen the existing food safety statutes enabling stronger prevention, enforcement, and record keeping activities;
• near-term efforts to strengthen agency coordination to improve the efficiency and effectiveness of Federal food safety activities; and
• the development of comprehensive, unifying legislation, followed by the development of a corresponding organizational reform plan that protects the public's health by allowing risk-based allocation of resources and utilization of science-based regulation, enforcement, and education. This comprehensive framework should address food safety standard setting, inspection, enforcement, research, and education.

APPENDIX A:

Administration Accomplishments

To ensure that our food supply remains among the safest in the world, the Clinton-Gore Administration has made reducing foodborne illness a national priority. The Administration has put in place improved safety standards for meat, poultry, and seafood products, and developed enhanced standards for fruit and vegetable juices. Research, education, and surveillance efforts have also been greatly expanded. Significant milestones in the Administration's efforts:

The President's Food Safety Initiative

By the mid-1990's, there was a growing consensus among experts and the public that food safety needed increased government attention. This view grew out of the availability of better data exposing the magnitude of foodborne illness and a clearer appreciation of the potential implications for food safety of changes in how food is supplied. It also grew out of a series of tragic, highly publicized food poisoning deaths from unpasteurized fruit juice and undercooked fast food hamburgers which galvanized public opinion in support of government action.

In January 1997, President Clinton set a course to strengthen the nation's food safety system. The launch of the President's Food Safety Initiative (FSI) set in motion later the same year a number of important efforts to promote public health and improve food safety. The FSI initially focused on the goal of reducing the number of illnesses caused by microbial contamination of food and water, and has resulted in the identification and control of a number of hazards, enhanced surveillance of foodborne disease, and innovative risk communication efforts.

• FSI stimulated the development of such innovative, award-winning programs as PulseNet, which fingerprints the DNA pattern of pathogens, and FoodNet, which conducts active surveillance of foodborne illness. These new tools vastly improve our ability to monitor disease and detect outbreaks. In just three years, FoodNet has been expanded to nine locations representing more than 10% of the U.S. population, and PulseNet has been enhanced to cover Salmonella, Shigella and Listeria as well as E.coli O157:H7.
• Science-based risk management strategies such as meat, poultry, juice, and seafood Hazard Analysis Critical Control Point (HACCP) programs are also making significant differences in public health protection and the safety of our food supply with their focus on prevention strategies. Approximately 300 of the largest meat and poultry plants implemented HAACP in 1998, followed in 1999 and 2000 by implementation in almost 6,000 additional, small plants, and very small Federal and state plants. HACCP also applies to all seafood processors and importers and has just been finalized for the processors of packaged fruit and vegetable juices.
• The Partnership for Food Safety Education, another award-winning, innovative component of the Food Safety Initiative, joins the public and private sectors to communicate with the public about effective food safety measures they can take to help ensure their continued health. Together the Partnership created the popular, new "Fight Bac!" campaign that is teaching consumers and other food handlers simple practices to prevent foodborne illness.
• Guidance was published for growers, packers and shippers of fresh fruits and vegetables, containing information on agricultural management practices that can enhance the safety of fresh produce, and training was conducted for these sectors.

These actions have already made a substantial difference. In just three years, there has been a 20% decrease in foodborne illness due to the major bacterial food pathogens across the United States. The real benefits of this accomplishment are being reaped by consumers across the nation: this 20% decline in illness suggests that about a million foodborne illnesses have been prevented. Fewer families suffer the loss of a loved one. Millions of dollars that would have been spent taking care of people sickened by their foods are being saved.

APPENDIX B

President's Council on Food Safety

EXECUTIVE ORDER 13100
PRESIDENT'S COUNCIL ON FOOD SAFETY

By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to improve the safety of the food supply through science-based regulation and well-coordinated inspection, enforcement, research, and education programs, it is hereby ordered as follows:

Section 1. Establishment of President's Council on Food Safety.

(a) There is established the President's Council on Food Safety ("Council"). The Council shall comprise the Secretaries of Agriculture, Commerce, Health and Human Services, the Director of the Office of Management and Budget (OMB), the Administrator of the Environmental Protection Agency, the Assistant to the President for Science and Technology/Director of the Office of Science and Technology Policy, the Assistant to the President for Domestic Policy, and the Director of the National Partnership for Reinventing Government. The Council shall consult with other Federal agencies and State, local, and tribal government agencies, and consumer, producer, scientific, and industry groups, as appropriate.

(b) The Secretaries of Agriculture and of Health and Human Services and the Assistant to the President for Science and Technology/Director of the Office of Science and Technology Policy shall serve as Joint Chairs of the Council.

Section 2. Purpose.

The purpose of the Council shall be to develop a comprehensive strategic plan for Federal food safety activities, taking into consideration the findings and recommendations of the National Academy of Sciences report "Ensuring Safe Food from Production to Consumption" and other input from the public on how to improve the effectiveness of the current food safety system. The Council shall make recommendations to the President on how to advance Federal efforts to implement a comprehensive science-based strategy to improve the safety of the food supply and to enhance coordination among Federal agencies, State, local, and tribal governments, and the private sector. The Council shall advise Federal agencies in setting priority areas for investment in food safety.

Section 3. Specific Activities and Functions.

(a) The Council shall develop a comprehensive strategic Federal food safety plan that contains specific recommendations on needed changes, including measurable outcome goals. The principal goal of the plan should be the establishment of a seamless, science-based food safety system. The plan should address the steps necessary to achieve this goal, including the key public health, resource, and management issues regarding food safety. The planning process should consider both short-term and long-term issues including new and emerging threats and the special needs of vulnerable populations such as children and the elderly. In developing this plan, the Council shall consult with all interested parties, including State and local agencies, tribes, consumers, producers, industry, and academia.

(b) Consistent with the comprehensive strategic Federal food safety plan described in section 3(a) of this order, the Council shall advise agencies of priority areas for investment in food safety and ensure that Federal agencies annually develop coordinated food safety budgets for submission to the OMB that sustain and strengthen existing capacities, eliminate duplication, and ensure the most effective use of resources for improving food safety. The Council shall also ensure that Federal agencies annually develop a unified budget for submission to the OMB for the President's Food Safety Initiative and such other food safety issues as the Council determines appropriate.

(c) The Council shall ensure that the Joint Institute for Food Safety Research (JIFSR), in consultation with the National Science and Technology Council, establishes mechanisms to guide Federal research efforts toward the highest priority food safety needs. The JIFSR shall report to the Council on a regular basis on its efforts: (i) to develop a strategic plan for conducting food safety research activities consistent with the President's Food Safety Initiative and such other food safety activities as the JIFSR determines appropriate; and (ii) to coordinate efficiently, within the executive branch and with the private sector and academia, all Federal food safety research.

Section 4. Cooperation.

All actions taken by the Council shall, as appropriate, promote partnerships and cooperation with States, tribes, and other public and private sector efforts wherever possible to improve the safety of the food supply.

Section 5. General Provisions.

This order is intended only to improve the internal management of the executive branch and is not intended to, nor does it, create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers or any person. Nothing in this order shall affect or alter the statutory responsibilities of any Federal agency charged with food safety responsibilities.

WILLIAM J. CLINTON THE WHITE HOUSE, August 25, 1998

Current Members of The President's Council on Food Safety

• Secretary of Agriculture (USDA) Dan Glickman (co-chair)
• Secretary of Commerce Norman Y. Mineta
• Secretary of Health and Human Services (HHS) Donna Shalala (co-chair)
• Administrator of the Environmental Protection Agency (EPA) Carol M. Browner
• Director of the Office of Management and Budget (OMB) Jacob Lew
• Assistant to the President for Science and Technology Neal Lane (co-chair)
• Assistant to the President for Domestic Policy Bruce Reed
• Director of the National Partnership for Reinventing (NPR) Government Morley Winograd

• Jane E. Henney, Food and Drug Administration (FDA) Commissioner (co-chair)
• Catherine E. Woteki, USDA Under Secretary for Food Safety (co-chair)
• Tom Billy, Food Safety and Inspection Service (FSIS) Administrator
• Karen Deasy, Assistant Director, Food Safety Initiative, Centers for Disease Control and Prevention (CDC)
• Mike Dunn, USDA Under Secretary for Marketing and Regulatory Programs
• Dana Flower-Lake, OMB
• Tom Freedman, Domestic Policy Council (DPC)
• Mary Smith, DPC
• Cliff Gabriel, Office of Science and Technology Policy (OSTP)
• Bill Hubbard, Acting Deputy Commissioner for Policy, FDA
• Eileen Kennedy, USDA Deputy Under Secretary for Research, Education, and Economics
• Joe Levitt, Director, Center for Food Safety and Applied Nutrition, FDA
• Sam McKeen, Director, Seafood Inspection Program, National Marine Fisheries Service, Department of Commerce
• Dana Minerva, Deputy Assistant Administrator for Water, EPA
• Wendy Taylor, OMB
• Susan H. Wayland, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances, EPA

Strategic Planning Task Force Alternates and Other Contributors

Susan Alpert (FDA), Laina Bush (HHS), Lou Carson (FDA), Ken Clayton (Agricultural Marketing Service), Diane Coates (USDA/Food Safety), Larry Cooley (Consultant, Management Systems International), Noah Engelberg (OMB), Elaine Francis (EPA), Jerry Gillespie, Joint Institute for Food Safety Research (JIFSR), Margaret Glavin (FSIS), Judy Hecht (EPA), Karen Hulebak (FSIS), Bill Jordan (EPA), Art Liang (CDC), Jean Logan (NPR), Leslie Kux (FDA), Margaret Malanoski (OMB), Amandeep Matharu (OMB), Judy Nelson (EPA), Janice Oliver (FDA), Steve Ostroff (CDC), Morris Potter (formerly HHS), Phil Schwab (REE/USDA), Steve Teasley (USDA/Food Safety), Robert Tynan (FSIS and Task Force Executive Secretary), Caren Wilcox (USDA/ Food Safety).

Robert Buchanan (FDA), Marjorie Davidson (FDA), Sandy Facinoli (FSIS), Robert Lake (FDA), Kathleen Knox (EPA), Mark Manis (FSIS), Jesse Majkowski (FSIS), Phyllis Sparling (FSIS), Robert Tauxe (CDC), John Taylor (FDA), William Wagner (USDA/Cooperative State Research Education and Extension Service),

* Note: Many other Federal employees, too numerous to identify, made important contributions to development of the Strategic Plan though their participation in working groups, review of drafts, and preparation of supporting analyses. In addition, the Task Force received many valuable comments from state and local health and agriculture officials, consumers, industry, and other stakeholders through public meetings, consultations, and other forms of communication.

⁽²⁾ Under the broad provisions of the PSHA, FDA has authority to promulgate regulations to require, for example, registration, recordkeeping, detention, diversion, recall, and preventive controls. However, because this authority is limited to preventing risks from communicable disease, this authority does not apply to all food safety hazards covered in this Plan.

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