U.S. Department of Agriculture |
Department of Health and Human Services |
Environmental Protection Agency |
Department of Commerce |
January 19, 2001
President William Jefferson Clinton
The White House
Washington, D.C. 20500
Dear Mr. President:
In 1998, you created your Council on Food Safety and tasked us with developing a comprehensive strategic plan for Federal food safety activities that would establish a "seamless, science-based food safety system." Since its establishment, your Council has held several public meetings and consulted extensively with interested stakeholders.
On behalf of your Council on Food Safety, I am pleased to transmit our strategic plan to you. We believe that our plan builds a solid foundation for ensuring the safety of the food in the 21st century.
Your Council appreciates the leadership you have shown in the area of food safety and ensuring that the food Americans eat remains safe. Your vision has guided our work and has created lasting accomplishments that protect the entire Nation.
Sincerely,
Neal Lane |
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):
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.
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.
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:
The three primary regulatory agencies are supported by a number of other government organizations:
Other Supporting Agencies:
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:
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.
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 ThemesPublic Health ProtectionScience-based System Priorities Based on Risks Prevention Emphasis Responsible Government Oversight Everyone Has a Role |
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.
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.
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.
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.
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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.
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:
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:
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
1.1.1 Identify and coordinate priority research activities needed to support risk assessment related to all aspects of food safety including microbial, allergenic, pesticide, and other chemical related risks.
1.1.2 Develop new risk assessment methods, such as those for determining aggregate and cumulative risks from pesticides, as well as how to assess risks to vulnerable populations, and apply them in decision-making.
1.1.3 Ensure that the latest scientific information is used consistently in development of risk assessments.
1.1.4 Perform and regularly update risk assessments that are needed for scientifically sound, risk-based food safety policies and regulatory decisions.
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
1.2.1 Develop enhanced identification and surveillance systems, and related technologies that effectively anticipate and prevent new public health and food safety problems.
1.2.2 Develop enhanced microbial and chemical risk evaluation methods that better characterize potential risks to public health.
1.2.3 Facilitate the development of rapid tests for pathogenic microorganisms and chemical agents in food and clinical specimens to identify emerging threats and support the specific needs of public health officials, particularly regulators and inspection personnel.
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
1.3.1 Complete a comparative risk analysis of acute and chronic foodborne risks from microbial, chemical and physical hazards and periodically update the analysis.
1.3.2 Develop and update a comprehensive food safety research database linking researchers in a specific area of investigation to avoid duplication, assist in identifying gaps in research, and speed technology transfer.
1.3.3 Identify gaps in knowledge or science and establish priorities for a unified food safety research agenda through use of risk analysis to include: microbial hazards; chemical contaminants; pesticides; physical hazards; water used for food production and processing; animal feed; veterinary drugs and biologics; and drug and biologic residues.
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
1.4.1 Enhance the communication and coordination of food safety research activities among laboratories at Federal, state and local levels.
1.4.2 Increase interaction among scientists in the public and private sectors. These programs should:
1.4.3 Establish or identify extramural programs to conduct targeted research programs linked to food safety and public health priority needs.
1.4.4 Develop and enhance scientific skills and expertise to conduct risk assessment.
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
1.5.1 Evaluate the current system for establishing priorities and deciding the allocation of funding, and take steps to achieve overall food safety research program goals based on that evaluation.
1.5.2 Perform periodic scientific peer reviews of Federal food safety research and risk assessment programs.
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:
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.
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
2.1.1 Determine based on risk where standards are needed or need to be harmonized between state and Federal programs and among Federal programs. Identify Federal, state and local standards and regulations that are in place to address microbial, chemical, and physical hazards and assess their potential to be the basis for national standards.
2.1.2 Based on a gap analysis of the food safety risk management system, identify criteria to improve the effectiveness of existing programs at all levels, identify new programs, improve data management, and assess resources available to meet system requirements.
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
2.2.1 Facilitate industry adoption of preventive controls and test methods, as appropriate, based on risk, throughout the farm-to-table continuum.
2.2.2 Maintain performance standard-based HACCP programs and expand the use of this concept where appropriate.
2.2.3 Register new pesticides, reregister existing pesticides licensed before 1984, and reassess standards for pesticide residues in/on food.
2.2.4 Explore targeted labeling strategies to provide consumers the information necessary for them to prevent risks and feel confident in their selection of foods processed by enhanced safety technologies, such as irradiation.
2.2.5 Expand participation in international food safety organizations, such as the United Nations' Codex Alimentarius,
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
2.3.1 Upgrade the ability at all levels of government to conduct public health surveillance of foodborne illnesses and hazards in a timely and efficient way.
2.3.2 Expand the capacity and expertise of public health laboratories, including the nationwide network of State Health Department laboratories, to "fingerprint" the principal foodborne pathogens.
2.3.3 Increase special surveillance efforts to address a broader range of foodborne illnesses and hazards, including longer-term effects on special populations.
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
2.4.1 Extend monitoring of pathogens, pesticides, other chemicals, and physical hazards and current prevention practices.
2.4.2 Expand the use of information (surveys, surveillance results, and other tools and data) from private and other public sources to enhance the identification of unsafe foods.
2.4.3 Upgrade the ability at all levels (Federal, state, tribal, and local) to conduct surveillance of food products and production/processing hazards, and to communicate the results, in a timely and efficient way.
2.4.4 Improve and strengthen the ability at Federal, state, tribal, and local levels to conduct rapid targeted surveys of pathogens, chemicals, and physical hazards in foods, upgrade food laboratory standards and increase the consistency of laboratory methods.
2.4.5 Encourage development of a laboratory accreditation process to ensure consistency and comparability of analyses among state and local laboratories nationwide.
2.4.6 Develop a network of animal diagnostic laboratories to enhance national, systematic monitoring of food animal diseases, and testing in feeds and feed stuffs for microbial, chemical and other hazards that pose a food safety risk.
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
2.5.1 Maintain a high level of compliance with U.S. food safety standards for both domestic and imported foods.
2.5.2 Fully develop and implement an analytic framework for risk-based inspections that can be tailored to the needs of different agencies at all levels: Federal, state, tribal, and local. Use this framework to guide agencies in targeting and coordinating prevention and enforcement activities.
2.5.3 Prioritize inspections and allocate enforcement resources to those categories of foods determined by risk assessment to have potential for a "high risk" to public health, e.g., target inspections on the foods most frequently associated with illnesses; at facilities with a history of non-compliance; and at the most critical points in the farm-to-table chain for occurrence of hazard-producing or hazard-controlling events.
2.5.4 Expand the capacity of the entire food safety system to monitor and inspect for "high risk" chemical residues in both foreign and domestic food at critical points in the farm-to-table continuum.
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
2.6.1 Use Federal interagency task forces, Federal/state agreements, and public/private partnerships to identify, develop and implement voluntary or incentive programs to reduce or prevent risks where mandatory standards do not exist.
2.6.2 Promote voluntary "best practices" and quality assurance programs developed by industry and/or government to prevent or reduce hazards, such as encouraging the implementation of Good Agricultural Practices by domestic producers and foreign trading partners.
2.6.3 Promote integrated pest management, biologically integrated farming systems, and sustainable agricultural practices to reduce risks from pesticide use.
2.6.4 Explore incentives for industry to improve food safety such as preferential entry into Federal programs, information-sharing, or financial incentives.
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
2.7.1 Identify and reduce any hurdles that impede introduction and implementation of new technologies that contribute to food safety, and expedite government review of such new products and technologies.
2.7.2 Promote the development and use of diagnostic techniques and prevention approaches at all levels to ensure that food production inputs, such as fertilizers and water, do not adversely affect the food supply.
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
2.8.1 Upgrade the ability, at all levels, to conduct foodborne illness outbreak investigation and to respond in a timely, efficient and effective way.
2.8.2 Strengthen coordination among Federal, state, and local health and agriculture departments, and increase feedback on multi-state foodborne outbreaks through the use of interagency outbreak coordination teams and expanded electronic information systems.
2.8.3 Develop a seamless Federal, state and local response system through national protocols for initiating and conducting product source tracing and recalls, and assure adequate communication with industry and with the public during recalls.
2.8.4 Improve the traceback system in collaboration with appropriate industry groups by working to enhance product identification, tracking systems, and access to records.
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
2.9.1 Strengthen assessments of foreign food safety systems and conduct additional assessments of foreign regulatory systems to determine if the foreign country achieves the appropriate level of protection specified by the U.S. for domestic foods.
2.9.2 Coordinate and focus international and intergovernmental food safety policy development through the direct participation of senior level individuals from United States agencies in the United Nations Codex Alimentarius and other international bodies.
2.9.3 Provide technical assistance, as appropriate, to help developing countries improve their systems to meet U.S. standards, including:
2.9.4 Improve and expand, where needed, risk-based port-of-entry inspections that focus on chemical, pesticide, microbiological, and physical hazards.
2.9.5 Further enhance foreign inspections of food establishments that export products to the United States.
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
2.10.1 Evaluate and upgrade the food safety system continuously to: 1) identify areas for improvement in existing and newly developed programs; and 2) identify areas where new program activity is needed.
2.10.2 Use surveillance and monitoring data regarding food products and public health to examine trends over time in foodborne illnesses, pathogens, and chemicals.
2.10.3 Establish evaluation plans when developing major standards and regulatory programs for food safety and use national surveillance and outbreak investigation data and risk analyses to demonstrate the impact of better science-based food safety management.
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 21st 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:
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.
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
3.1.1 Create a state-of-the-art national information network to: 1) link Federal food safety departments and agencies (USDA, HHS, and EPA) with state, tribal and local public health, food safety, agricultural, education, and environmental agencies; 2) develop consistent and coordinated food safety messages and programs; and 3) provide easy access to information regarding regulatory changes.
3.1.2 Promote development of knowledgeable food safety communicators such as journalists, health professionals, and educators who can assist agencies in providing accurate information to the public.
3.1.3 Establish opportunities for public/private partnerships to promote effective, transparent communication about food safety risks, prevention strategies, and enforcement actions.
3.1.4 Communicate frequently with stakeholders on food safety to create ongoing opportunities for conversations about meeting food safety goals, policies, actions, and educational needs.
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
3.2.1 Establish active outreach and use new and emerging networks for sharing information to ensure that the public has rapid access to consistent and accurate information about food-related microbial and chemical contamination risks and public health emergencies.
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:
3.3.1 Inventory current food safety and relevant public health training and education programs, address gaps, and compile and disseminate this information.
3.3.2 Coordinate and integrate ongoing and new training and educational activities at all levels (Federal, state, and local governments as well as academia and industry) to create comprehensive, complementary training, education, and information programs. Capitalize on unique opportunities for reaching the public and remove barriers between groups and organizations that might otherwise have conflicting food safety concerns and training needs.
3.3.3 Establish job standards where such standards do not exist, including core competency requirements and training elements appropriate for a given area of food safety and level of expertise. The program could include a credentialing system for food safety inspectors, investigators, and program reviewers which would be uniform throughout the country and would encourage better communications between agencies and cross-utilization of personnel.
3.3.4 Establish a program for comprehensive training and education of inspectors, scientists, and public policy experts at the Federal, state, tribal, and local level. Training could also be open to all, including industry employees, to foster better communications and increased industry use of HACCP-based controls and other prevention strategies.
3.3.5 Expand the use of virtual technologies for providing on-line distance learning courses and develop other approaches that can deliver low cost, easily accessible training to all government inspectors, investigators, and program reviewers.
3.3.6 Launch a nationwide public information/education campaign to disseminate critical food safety messages in multiple formats and languages targeted toward both local and national audiences.
3.3.7 Expand health and food safety curricula at the elementary, middle, and secondary school levels.
3.3.8 Evaluate university curricula related to public health and food safety fields such as microbiology, food chemistry, toxicology, epidemiology and environmental health, and provide support for the development of appropriate professional programs.
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
3.4.1 Evaluate the effectiveness of information campaigns and communication, training and education programs. Utilize state, local and tribal health and education departments, Cooperative Extension offices, and other appropriate offices in these efforts. Disseminate results throughout the national food safety system to strengthen existing programs and develop new ones.
Today seven statutes provide HHS, USDA, and EPA with the primary tools to regulate food safety:
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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:
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.).
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:
Several key findings of the analysis influenced the Council's decisions. These findings were:
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.
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.
The Council concludes that:
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:
The Council recommends:
CLINTON-GORE ADMINISTRATION: A RECORD OF IMPROVING FOOD SAFETY
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:
January 2001 | FDA finalizes fruit and vegetable juice HACCP rule for all producers |
January 2001 | FDA and FSIS issue Draft Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat foods. |
January 2001 | FSIS and FDA issue Joint Report to the President: Reducing Risk of Listeria monocytogenes. |
January 2001 | FDA issues Draft Assessment on the Public Health Impact of Vibrio parahaemolyticus in raw molluscan shellfish. |
January 2001 | FDA and U.S. Customs issue Proposed Marking of Refused Imported Foods Rule. |
November 2000 | FDA finalizes safe handling labels and refrigeration requirements for marketing shell eggs. |
December 1999 | Announced Egg Safety Action Plan that will cut in half by 2005 the number of Salmonella Enteritidis (SE) illnesses attributed to eggs, and will set a goal of eliminating such illnesses altogether by 2010. |
July 1999 | Directed the Department of HHS and the Treasury Department to explore additional actions to protect consumers from unsafe imported foods. |
Jan. 1999 | Implemented new science-based inspection system called Hazard Analysis-Critical Control Points (HACCP) in almost 3,000 small meat and poultry plants. |
Oct. 1998 | Published guidance for growers, packers, and shippers of fresh fruits and vegetables to provide information on good agricultural and management practices. |
Aug. 1998 | Created the President's Food Safety Council, charged with developing a strategic plan for Federal food safety activities and ensuring that all relevant agencies work together to develop coordinated food safety budgets each year. |
July 1998 | Announced Joint Institute for Food Safety Research, which will develop a strategic plan for conducting and coordinating all Federal food safety research activities, including with the private sector and academia.
Announced new warning labels on packaged fresh fruit and vegetable juices that have not been processed to prevent, reduce, or eliminate illness-causing microbes. |
May 1998 | Formed national computer network of public health laboratories, called "PulseNet," to help rapidly identify and stop outbreaks of foodborne illness. The new system enables epidemiologists to respond up to five times faster than before in identifying serious and widespread food contamination problems by performing DNA "fingerprinting" on foodborne pathogens. |
Feb. 1998 | Announced proposed food safety budget, which requests approximately $101 million increase for food safety initiatives. |
Jan. 1998 | Implemented new, science-based HACCP system for 300 largest meat and poultry plants. |
Dec. 1997 | Approved irradiation of meat products to control disease-causing microorganisms. Implemented seafood HACCP regulations for all seafood processors. |
Oct. 1997 | Ordered additional actions to improve the safety of domestic and imported fruit and vegetables.
Established Partnership for Food Safety Education, an ambitious Federal-private partnership to reduce foodborne illness by educating Americans about safe food handling practices. The Partnership has launched a multi-year, broad-based public education campaign to teach Americans about safe food-handling practices. |
May 1997 | Announced comprehensive new initiative to improve the safety of nation's food supply—"Food Safety from Farm to Table"--detailing a $43 million food safety program, including measures to improve surveillance, outbreak response, education, and research. |
Jan. 1997 | Unveiled National Food Safety Initiative, a five-point plan working with consumers, producers, industry, states, universities, and the public to strengthen and improve food safety.
Announced new early warning system, the Foodborne Outbreak Response Coordinating Group (FORC-G), a partnership of Federal and state agencies, to develop a comprehensive, coordinated national foodborne illness outbreak response system to increase coordination and communication among Federal, state, and local agencies; guide efficient use of resources and expertise during an outbreak; and prepare for new and emerging threats to the U.S. food supply. |
Aug. 1996 | President signed Safe Drinking Water Act of 1996, which requires drinking water systems to protect against dangerous contaminants such as Cryptosporidium and gives people the right to know about contaminants in their tap water.
President Clinton signed Food Quality Protection Act of 1996, which streamlines regulation of pesticides by FDA and EPA and puts important new public-health protections in place, especially for children. |
July 1996 | Announced new HACCP regulations that modernize the nation's meat and poultry inspection system for the first time in 90 years. New standards help prevent E. coli bacteria contamination in meat. |
Jan. 1996 | The Foodborne Diseases Active Surveillance Network (FoodNet), a collaborative effort among HHS and USDA, along with state health departments and local investigators around the country, begins collecting data to better track the incidence of foodborne illness and monitor the effectiveness of food safety programs in reducing foodborne illness. |
Dec. 1995 | Issued new rules to ensure seafood safety, using HACCP regulatory programs to require food industries to design and implement preventive measures and increase the industries' responsibility for and control of their safety assurance actions. |
1994 | Embarked on CDC strategic program to detect, prevent, and control emerging infectious disease threats, some of which are foodborne, making significant progress toward this goal in each successive year.
Reorganized USDA to establish Office of the Under Secretary for Food Safety. This increases the visibility of food safety within USDA and separates food safety functions from marketing functions carried out by other parts of USDA. Reorganization also creates a new Office of Public Health and Science within FSIS to improve the scientific base needed to make sound regulatory decisions, based on public health. |
1993 | Vice-President Gore's National Performance Review issued a report recommending that government and industry move toward a system of preventive controls for food safety. |
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.
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.
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, |
Current Members of The President's Council on Food Safety
Strategic Planning Task Force, The President's Council on Food Safety
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).
Task Force Interagency Working Group Chairs and Co-Chairs
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.
(1) Ensuring Safe Food from Production to Consumption, Institute of Medicine and National Research Council, August 1998.
(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.