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U.S. Department of Agriculture |
Department of Health and Human Services |
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U.S. Department of Agriculture |
Department of Health and Human Services |
Environmental Protection Agency |
Department of Commerce |
Background and Introduction: As announced in the Federal Register on December 15, 1999, the President's Council on Food Safety will host a meeting on January 19, 2000 to discuss the Council's development of a federal Strategic Plan for food safety. The Federal Register Notice included a synopsis of the draft plan in order to provide examples of the types of objectives and actions that will be included in the Strategic Plan document, and to stimulate thinking and public comment about the essential components of an effective food safety strategy. In the Federal Register Notice, the Council also announced that an expanded draft of the Strategic Plan, titled ''Preliminary Food Safety Strategic Plan for Public Review,'' would be available prior to the public meeting.
The document presented here is the preliminary Strategic Plan for public comment. As indicated in the Federal Register Notice, the Council wants to engage all interested stakeholders in a further discussion about the draft goals, objectives, and action items for the U.S. food safety system, as well as whether organizational or other changes would facilitate achievement of the goals. The Council also is interested in suggestions for additional objectives and action items, as well as comments on the priorities, ways to measure progress and mechanisms for successful implementation of the plan. Participants in the upcoming public meeting and other interested parties are strongly encouraged to read both the Federal Register Notice and the preliminary Strategic Plan before attending the public meeting or submitting comments.
Following the public review and comment process, the preliminary Strategic Plan will be refined. The final plan will include evaluation strategies to determine whether public health goals are met, and whether mid-course corrections to the plan are needed. Mechanisms for measuring progress and public health impact of the Strategic Plan will be developed in each goal area. The plan will also include an examination of whether organizational, statutory, or other changes can contribute to implementation of the plan and achievement of the goals.
The Council is particularly interested in comments on the following issues related to the draft Strategic Plan. These questions will be the starting point for discussion at the public meeting sessions on the overall framework for the plan, and on the three draft goals .
General / Cross-cutting Question Regarding the Draft Plan:
Questions Regarding Each Draft Goal:
The following pages present the preliminary food safety Strategic Plan starting with an outline of the Goals and Objectives.
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.
FOOD SAFETY: THE NATION'S CHALLENGE
Today's challenges with respect to public health and the food supply are exceedingly complex. While the American food supply is among the safest in the world, each year millions of people in the United States are stricken by illness caused by the food they consume, and some -- mostly the very young, elderly, and immune-compromised -- die every year as a result. Hospitalization costs for these illnesses are estimated at more than $3 billion a year and costs from lost productivity are much higher. Moreover, the causes of many of these illnesses are unknown, and research continues to raise new concerns about emerging threats from microorganisms and chemicals.
In recent years, much has changed in what we eat and where we eat. Americans are eating a greater variety of foods, particularly poultry, seafood and fresh fruit and vegetables. This is beneficial to our health, but presents new food safety challenges. More consumers demand these foods year round, making safety issues surrounding transportation and refrigeration increasingly important. As international trade expands, shifting regional commerce and products to a global marketplace, the challenge of ensuring the safety of food expands as well. Americans are 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. The result is that, as fewer people are involved in preparing their own meals, the chance for disease-producing errors increases. 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. These forces make extremely urgent the need for a comprehensive, coordinated, forward-looking Strategic Plan for strengthening the systems that ensure the safety of the nation's food supply.
FOOD SAFETY REGULATION TODAY
The Administration has adopted a farm-to-table approach that looks at food safety as an integrated and interdependent system, which is important because of the historical split jurisdictions and differing statutory authorities and responsibilities across several Federal agencies.
Three agencies currently have the major regulatory responsibilities for food safety at the Federal level: the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA); the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS); and the Environmental Protection Agency (EPA). FSIS ensures the safety of meat, poultry, and some egg products in interstate and international commerce. FDA regulates all domestic and imported foods that are marketed in interstate commerce except for meat, poultry, and some egg products. EPA licenses pesticide products and establishes maximum limits for pesticide residues (tolerances) in food and animal feed while FDA and FSIS enforce those pesticide tolerances in the commodities under their jurisdiction. EPA also establishes standards for surface, and drinking water.
Since 1906, the Food and Drug Administration (FDA), now within HHS, and its predecessor agencies, and the Food Safety and Inspection Service (FSIS), within USDA, and its predecessor agencies, have been authorized by Congress to protect the nation's food supply. While these agencies have a common purpose of protecting the safety of the food supply, the laws establishing each agency's authority differ considerably and, in some cases, dictate the agency's approach to implementation. For example, in determining the acceptability of food products, the FDA and FSIS apply comparable statutory standards -- the adulteration provisions of the Federal Meat Inspection Act; the Poultry Products Inspection Act; the Egg Products Inspection Act, and the Federal Food, Drug and Cosmetic Act. However, under its three statutes, FSIS is required to maintain a continuous inspection program for meat, poultry and egg products, and establishments producing these products must inform the agency prior to production. The burden under those acts is that FSIS inspectors must make a determination that products are not adulterated before the mark of inspection can be applied and the products permitted to move in commerce. There is no similar requirement in the Federal Food, Drug and Cosmetic Act - FDA has the burden of proving that food is adulterated. Congress obviously took a different approach to food safety when formulating these Acts.
The Environmental Protection Agency (EPA) also plays an important 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 Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) has historically been science-based, using risk assessment principles to determine whether a pesticide should be licensed for use on designated crops and to establish maximum allowable residue levels in/on food. This was further strengthened by the 1996 Food Quality Protection Act (FQPA) which mandates that EPA look, among other things, at aggregate exposure, cumulative risk, and the potential need for additional factors to protect infants and children.
Based on the authorizing language and their history, the agencies have developed different systems for protecting the food supply, and bring different strengths and shortcomings to the current system.
These regulatory agencies are supported by a number of other organizations. The Centers for Disease Control and Prevention (CDC), in DHHS, plays a critical and unique role as a disease monitoring, investigative, and advisory agency that is separate from -- but works closely with -- food regulatory agencies. CDC leads Federal efforts to gather data on foodborne illness and investigate outbreaks, and monitors the effectiveness of prevention and control efforts. Through its on-going public health efforts, CDC also plays a pivotal role, building state and local health department epidemiology and laboratory capacity to support foodborne disease surveillance and outbreak response. The Agricultural Research Service (ARS), the Cooperative State Research, Education and Extension Service (CSREES), and the Economic Research Service (ERS) of USDA as well as the National Institutes of Health (NIH), which is part of DHHS, play important roles in conducting food safety research, in addition to the research done by some of the food safety agencies. The National Marine Fisheries Service (NMFS) within the Department of Commerce (DOC) 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.
The Strategic Plan under development proposes to build on the existing public health and regulatory systems, strengthen them, and promote coordination whenever possible. In addition, the draft plan takes into account the strengths that various state food safety systems may bring to the protection of food, and makes recommendations about how the federal government might build on those systems as well. As part of the Strategic Planning process, evaluations are being made of the current statutes and regulations impacting food safety as well as the organizational structure of the federal food safety program. The initial part of the organizational assessment is presented later in this draft to support discussion of additional ways that efficiency might be achieved over the longer term.
PRESIDENT'S FOOD SAFETY INITIATIVE
In January 1997, President Clinton set a course to strengthen the nation's food safety system. The Food Safety Initiative (FSI) initially focused on the goal of reducing the number of illnesses caused by microbial contamination of food and water. Under the President's leadership, federal and state agencies have enhanced surveillance of foodborne disease and better coordinated our response to outbreaks. We have improved coordination of food safety programs, issued science-based regulations, and targeted important new research and risk assessment to critical scientific gaps. And, working collaboratively with industry, agencies have strengthened education and training, especially for those who handle food at critical points from the retail setting to the home. Much has been accomplished. As the challenges to our food safety system continue to evolve, however, the system must adapt to meet these changing needs. The food safety system must be capable of responding to and preventing foodborne illness and food hazards through the most effective means possible.
At the request of Congress, the National Academy of Sciences (NAS) conducted a study of the current food safety system and issued its report on "Ansuring Safe Food from Production to Consumption" in August 1998. The scope of the NAS study was broader than that of the Food Safety Initiative. The report focused on microbial, chemical and physical hazards from "substances that can cause adverse consequences" in domestically-produced and imported foods, including additives, pesticides and animal drug residues. The NAS report defined the operational charge or mission of an effective food safety system "to protect and improve the public health by ensuring that foods meet science-based safety standards through the integrated activities of the public and private sectors." The NAS report also recommended that a comprehensive, national food safety plan be developed and 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.
Recognizing the broad scope of current hazards and emerging threats to the food supply and building on the recommendations of the NAS report, the President issued Executive Order 13100 creating the Council on Food Safety. The Council's goal is to make the food supply safer through a seamless, science-based food safety system supported by well-coordinated research, risk assessment, standards, surveillance, inspection, enforcement, education and strategic planning. The President specifically directed the Council to develop a comprehensive federal strategic food safety plan to improve the current system and to anticipate future needs.
PRESIDENT'S COUNCIL ON FOOD SAFETY - STRATEGIC PLANNING
To address the President's directive, the Council established an interagency Strategic Planning Task Force. The Strategic Plan will address the full range of food safety issues, long- and short-term, to further ensure the health and safety of the nation's food supply. It will help set priorities, improve coordination and efficiency, identify gaps in the current system and ways to fill those gaps, enhance and strengthen prevention and intervention strategies, and identify reliable measures to indicate progress. The Plan's overarching goal is to protect public health.
The Plan under development aims to establish priorities on the basis of risk and to create an integrated seamless food safety system. It has three broad and complementary goals: The United States' food safety system is based on sound science and risk assessment; the United States system for managing food safety is effective from farm to table; and the United States food safety system openly and effectively provides information on food safety risks, and education on how to control those risks. Each goal includes major objectives to be addressed, along with some specific action items. As part of the strategic planning process, the Council is also examining whether organizational, statutory, or other changes to the federal food safety system will facilitate achievement of public health and food safety goals.
Guiding Themes
Six major themes have emerged in developing the draft Preliminary Food Safety Strategic Plan presented here for discussion. First, as recommended by the NAS report, " the food safety system must rest on sound science". Thus, a critical dimension of each aspect of the Strategic Plan (science and risk assessment, risk management, and risk communication) is to collect, analyze, disseminate, and fully use objective, reproducible, scientific information about the nature and extent of food safety hazards and the means of preventing them.
Second, the plan proposes the need to select priorities based on where the scientific data show the greatest food safety risks. As it has in the past, risk-based priority setting will continue to shape budget choices, research agendas, risk management targets - indeed will guide every aspect of the effort to strengthen programs to protect the food supply.
Third, the Strategic Plan recognizes that, ultimately, what matters is its impact on public health: has it made the food supply safer; have we reduced foodborne illnesses and hazards? Therefore, the Strategic Plan consistently includes objectives to measure the results of ongoing programs and new initiatives in terms of improvement of public health.
A fourth theme shaping the direction of this Strategic Plan is prevention. The old maxim, "an ounce of prevention is worth a pound of cure," holds especially true in the arena of food safety. Science is only beginning to assess the burden of microbially-caused food-borne illness and the potential risks of chemicals, contaminants and other hazards in foods are also inadequately characterized. Decades of experience have taught us that it is more effective, and less expensive, to prevent food safety problems than to respond to outbreaks after they have occurred. By swiftly applying our science-based understanding of the causes of foodborne hazards, government can 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 to emerge during this planning focuses on the regulatory approaches that are used to protect the food supply. A major obligation of the federal, state, tribal and local agencies is oversight of the regulated industry and the enforcement of their laws and regulations. This not only ensures a safe food supply, but builds a fair and even playing field for all who choose to enter the food industry for commercial purposes. Fair and evenhanded enforcement of the various laws and implementing regulations has to be a key element of any food safety plan. This will also contribute to the acceptance of United States' food products both within the U.S. and outside its borders, wherever they may be consumed.
Finally, coordination of everyone's efforts is essential to the Plan's success. Given the breadth of the farm to table continuum -- from tens of thousands of farms to millions of restaurants and supermarkets to hundreds of millions of homes -- assuring the safety of the nation's food supply must be everyone's shared responsibility. Particularly, the federal agencies and their state, local, and tribal counterparts must work more closely together to assure comprehensive, efficient, consistent, and equitable regulation of the food industry and to create an integrated, seamless food safety system that protects the U.S. consumer. Partnerships among governments, including governments of other countries, academia, and the private sector are also vital to the success of the Plan.
Draft Framework
In the Fall of 1998, the Council held a series of public meetings to obtain the public's view on a long-term vision for food safety in the U.S., to identify the important food safety challenges for the Strategic Plan and to solicit public comment on the NAS report. Based on these meetings, the Strategic Planning Task Force developed draft Strategic Plan goals and objectives. The original draft goals and objectives were the basis for a public meeting in July 1999, and for discussions with stakeholders at scientific and professional meetings during the latter part of 1999. Federal interagency working groups were established to revise the draft plan based upon comments from stakeholders. At this time, the Council wants to engage all interested stakeholders in a discussion of the revised goals, objectives and action items being presented here. The Council also is interested in suggestions for additional objectives and action items, as well as comments on the priorities, ways to measure progress and mechanisms for successful implementation of the plan.
The goal of the Strategic Plan is to make the food supply even safer than today as proposed in the Vision Statement and reaffirmed in the Overarching Goal:
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.
The following sections of this document present the three broad and complementary Strategic Plan goals:
The United States' food safety system is based on sound science and risk assessment;
The United States system for managing food safety is effective from farm to table; and
The United States food safety system openly and effectively provides information on food safety risks, and education on how to control those risks.
Each goal section also includes major objectives to be addressed, along with some specific action items.
SCIENCE AND RISK ASSESSMENT
From developing new tools to identify, prevent, or eliminate food hazards, to performing basic research on pathogens and their impact on humans and animals, to developing risk assessment methodologies for multiple chemical exposures, to researching and conveying important information for consumers about safe food handling methods, food safety science and research play an integral role in the Administration's food safety strategy. An effective food safety system must not only be based on sound science, but also be capable of dealing with current and emerging public health concerns on the basis of the risk they present to the consumer. Thus, the Strategic Plan incorporates the NAS report's focus on the use of scientific risk assessment to guide the development of rules, policies and other approaches that will have the most positive
influence on public health. Risk analyses, including an assessment of risks and benefits, are helpful in defining the extent of scientific certainty and in helping decision-makers make the tough decisions a science-based food safety system requires.
There are, however, a number of challenges to improving the scientific base of the food safety system. For example, gaps exist in our knowledge of microbial pathogens and in our ability to measure their impact on human health; the assessment of the total impact on health of multiple chemicals from multiple sources presents a major challenge; the limited existing body of knowledge about microbial contamination limits the ability to develop on-farm preventive controls and systems of testing; insufficient data exist on the entire range of infectious and non-infectious foodborne hazards, including emerging hazards such as endocrine disruptors. Therefore, the foundation underlying any food safety system includes the articulation and implementation of a unified research agenda to provide the scientific knowledge needed for prevention, monitoring, surveillance, inspection, regulation, and education programs. The application of this knowledge in a systematic manner requires the ability to conduct qualitative and quantitative risk assessments. This research agenda must be flexible to meet new food safety challenges and support the needs of regulatory agencies for research that leads to appropriate enforceable regulations and other actions.
Action Items
Action Items
Use surveys, surveillance and other tools and data from public and private sources to identify adverse health outcomes related to foods.
Encourage data sharing among all relevant sources of food safety information.
Action Items
Action Items
Develop enhanced identification and surveillance systems, microbial and chemical risk evaluation methods, and related technologies that effectively anticipate and prevent new public health/food safety problems.
Facilitate the development of rapid tests for pathogenic microorganisms and chemical agents in food and clinical specimens.
Develop new risk assessment methods, such as those for determining aggregate exposures and cumulative risks, as well as consideration of sensitive sub-populations, and apply them in decision-making.
Action Items
Action Items
Use surveillance and monitoring data regarding food product composition and public health to examine trends over time in foodborne illnesses, pathogens and chemicals.
Evaluate the current system for establishing priorities in and deciding the allocation of funding for food safety research. Based on that evaluation, undertake steps to achieve overall program goals.
Perform periodic scientific peer reviews of federal food safety research and risk assessment programs.
RISK MANAGEMENT
Foodborne illnesses and injuries have many causes. Food can become contaminated at many points from farm to table. Many factors make some groups of people more susceptible than others. No single preventative measure and no single regulatory or enforcement strategy will ensure the safety of all foods. To protect health and manage risk in the food safety system, effective production, marketplace and disease surveillance, monitoring, and other basic public health functions are essential. Public health and food safety data must be gathered, analyzed and provided to public health and regulatory agencies to aid them in identifying immediate and longer term conditions or hazards that can threaten public health.
Public health, production, and marketplace surveillance play important roles in risk management. Public health surveillance estimates the number of specific illnesses that may be related to food, defines the burden of disease, and provides early warning of disease outbreaks so they can be investigated and controlled. Public health, production and marketplace surveillance combined with epidemiologic investigations can define which foods or food production, processing, or handling practices are sources of illness or expose people to risk. Rapid public health and regulatory agency response to foodborne outbreaks, including enforcement actions, is critical to limit public health consequences. As risk management steps are implemented, surveillance helps to document whether regulatory and other prevention efforts are working.
There are a number of important challenges to be addressed in managing the risks from foodborne hazards. Once risks or adulteration have been identified, consideration must be given to (1) prevention strategies, (2) the availability of tools to control the risks, including, where appropriate, performance standards, (3) assessment programs to monitor and survey activities directed at prevention and control, (4) surveillance to assess the effectiveness of these activities, and (5) inspection and enforcement of regulatory requirements address the risks or immediate hazards. Another challenge is to allocate resources where risk is high. Allocation of resources based on risk influences what is emphasized in the areas of research, regulation, inspection and enforcement as well as education and training. There are many roles to be fulfilled if risk management is to be effective. Everyone in the chain needs to understand the hazards being addressed and the tools for their prevention and control.
The federal agencies currently use a number of approaches to assure food safety, many are mandatory and some are voluntary. There are mandatory obligations, both statutory and regulatory, that are placed on the food industry. The food safety system relies on inspection, monitoring, and surveys of the food supply as tools to measure whether foods are meeting safety standards and expectations. If unacceptable food safety risks such as adulteration are identified the system uses enforcement provisions of the laws to correct or improve the situation. An effective system for managing food safety includes national, risk-based standards and baseline expectations for risk reduction that will help prevent or control foodborne hazards.
Programs that create incentives to improve food safety can effectively complement, direct and build upon regulation through national standards. These programs, both regulatory and voluntary, fill a variety of needs. Most importantly, they transform the levels of protection accomplished by regulatory measures from a "ceiling" into a "floor." Incentive programs encourage the regulated community to move beyond the minimum efforts required to achieve compliance and to reach higher levels of assurance and protection. They also allow the government and regulated community to gain experience with emerging technology and to design programs for areas where regulation either is inappropriate or does not exist.
An effective system needs to monitor for gaps in food safety data and to support coordination among everyone in the farm to table system having a role in prevention of food safety hazards and in responding to foodborne hazards that do occur. When food safety emergencies or new emerging food risks are identified, the system must respond quickly and effectively to protect public health. The system should coordinate activities at all levels (federal, state, tribal and local) to minimize food safety risks and use resources wisely. The system also includes a strategy for imported foods. Finally, the system will incorporate program evaluation to determine the effectiveness of the system in meeting all of its objectives for managing food safety risks.
RISK MANAGEMENT GOAL:
Action Items
Using risk criteria determine where standards are needed or need to be harmonized between state and federal and among federal programs and develop a plan to meet these needs.
Action Items
Facilitate industry adoption of preventive controls, as appropriate based on risk, throughout the farm-to-table continuum.
Maintain performance standard based, HACCP programs and expand the use of this concept where appropriate.
Promote targeted labeling strategies to provide consumers the information necessary for them feel confident in their selection of foods processed by enhanced safety technologies, such as irradiation.
Action Items
Monitor hazards and prevention practices.
Upgrade the ability at all levels (federal, state, tribal, and local) to conduct public health surveillance of foodborne illnesses and hazards in a timely and efficient way.
Expand the capacity of public health laboratories, including the nationwide network of State Health Department laboratories.
Increase special surveillance efforts.
Develop a network of animal diagnostic laboratories to enhance national, systematic monitoring in animal feeds and feed-stuffs for microbial, chemical and other hazards that pose a food safety risk.
Upgrade food laboratory standards and infrastructure at federal, state and local levels.
Action Items
Prioritize for inspection those categories of foods determined by risk assessment to pose a "high risk" to public health.
Promptly report identified outbreaks, safety risks and violations of food safety standards to all appropriate federal, state, tribal and local regulatory agencies for investigation and possible enforcement actions.
Expand the capacity of the entire system to monitor and inspect for "high risk" pesticides and other chemical contaminants at critical points in the farm-to-table continuum to decrease food safety risks and identify violations.
Develop an analytic framework for constructing algorithms for risk-based inspections at all levels; federal, state, tribal and local.
Action Items
Maintain and augment, where necessary, trained enforcement and compliance officers and, based on foodborne risks, utilize these individuals to maintain a high level of compliance with U.S. food safety laws for both domestic and imported foods.
Develop additional national training and job standards where such standards do not exist.
Allocate enforcement resources on the basis of greatest risks.
Action Items
Develop and/or implement programs to address areas where mandatory standards do not exist.
Promote voluntary "best practices" and quality assurance programs developed and implemented by industry and/or government.
Promote integrated pest management, biologically integrated farming systems, and sustainable agricultural practices to reduce risks from pesticide use.
Use incentive programs to improve food safety.
Action Items
Expedite licensing and encourage the development and use of new technologies and safer pesticides.
Expedite the review of food additive and pesticide petitions that are intended to decrease the incidence of foodborne illnesses through their antimicrobial actions against microbial hazards that may be present in food.
Expedite review of new animal drugs that are intended to reduce food safety risks.
Promote development and use of preventive techniques and controls at all levels to ensure that inputs such as fertilizers and water will not adversely affect the food supply.
Action Items
Upgrade the ability, at all levels (federal, state, tribal, and local), to conduct outbreak investigation and response in a timely and efficient way.
Strengthen coordination between federal, state, tribal and local health departments, and increase feedback on multi-state foodborne outbreaks through the use of interagency outbreak coordination teams.
Facilitate a seamless local, state and federal response system
Make the conduct of trace-back easier.
Expand the electronic information system for public health officials for reporting potential foodborne outbreaks and increase coordination between reporting systems.
Action Items
Strengthen assessments of foreign systems and conduct additional assessments of foreign regulatory systems, as appropriate, to determine if the foreign country provides the appropriate level of protection specified by the U.S. for domestic foods.
Coordinate Federal activity in all international inter-governmental settings for dealing with food safety issues.
Provide technical assistance, as appropriate, to help developing countries improve their systems to meet U.S. standards. This may be done by:
Sharing information on international food safety technical assistance activities and resources from U.S. and foreign governments, industry and consumer sources, and international organizations; and
Entering into MOUs with international organizations to further coordinate technical assistance.
Improve and expand, where needed, risk-based port-of-entry inspections that focus on chemical, microbiological, and physical hazards as well as labeling issues to promote public health.
Action Items
Evaluate and upgrade the food safety system periodically.
Incorporate evaluation plans when developing major standards and regulatory programs for food safety and use national surveillance and outbreak investigation data and risk analysis to demonstrate the impact of better science-based food safety management.
RISK COMMUNICATION
To create effective food safety policies and programs and build public confidence in the food safety system, requires open, transparent decision making and accurate, timely exchange of information and ideas among stakeholders. It is critical to ensure that all points of view are heard and considered as the policies and programs are developed. Efficient collection of the best information from all appropriate sources must be brought to bear on decision making, particularly as federal agencies deal with emergencies and emerging new threats to food safety. Science based information and education programs need to be developed and continually evaluated and updated to ensure maximum impact on public health.
Information and education play a critical role in ensuring that everyone involved meets their responsibilities for food safety. Everyone involved in the global farm-to-table chain --" producers and growers, transporters, workers in various segments of the food processing industry, retail food service workers and consumers, regulators, and health professionals -- needs to be informed of food safety risks and their role in reducing those risks. As research and experience reveal new information on the characteristics and transmission of foodborne hazards, food safety agencies must rapidly incorporate new information into education and information programs.
Information and education also play an important role when surveillance and inspections reveal a threat to the public health. 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 minimize public health threats. This flow of information must occur in an open and candid way to ensure the public's trust in the food safety system.
RISK COMMUNICATION GOAL
Action Items
Create a state-of-the-art national information network.
Promote development of knowledgeable food safety communicators.
Establish opportunities for public/private partnerships to promote effective transparent communication about food safety risks, prevention strategies and enforcement actions.
Launch a nationwide public information/education campaign.
Communicate frequently with stakeholders on food safety.
Action Items:
Develop consistent and coordinated food safety messages and programs.
Identify and promote public-private educational partnerships.
Expand opportunities to utilize virtual technologies for providing online distance learning courses.
Create professional development opportunities for science teachers.
Evaluate university curricula related to food safety fields and provide support for the development of appropriate professional programs so the programs are in place to train the workforce of the future.
Action Items
Establish active outreach strategies to provide rapid public access to information about food safety emergencies.
Assure consistency and accuracy of information about food safety emergencies.
Develop public health education kits in multiple formats and languages.
Action Items
Evaluate the effectiveness of information campaigns and education programs.
Expand the use of interactive web sites.
ORGANIZATIONAL CONSIDERATIONS
As outlined previously, the overarching goal of the food safety system is "to protect public health by significantly reducing the prevalence of foodborne hazards...". As the Strategic Plan goals, objectives, and action items are being developed, the Council is analyzing whether existing structures and approaches may need to be refined, strengthened, or changed. Organizational options, facilitating mechanisms, and other potential changes are being examined for their ability to achieve the Plan's goals. With this interconnectedness in mind, the Council is presenting a wide range of organizational options which are under review. Public input is being solicited on whether and how structural changes will facilitate achievement of Strategic Plan's goals.
There are a number of dimensions or variables to be considered in examining the federal food safety system. These include:
Evaluation Criteria
The food safety system must be seamless and must facilitate the integration of research, surveillance, inspection, enforcement, and education functions of the federal government. In order to ensure food safety and public health protection, the federal food safety system must also facilitate the implementation of the science- and risk-based strategies being developed in the Strategic Planning process.
In addition to meeting public health and food safety goals, the federal food safety system must be effective, efficient, science-based, and comprehensive, and instill public confidence.
Other considerations with both long- and short-term consequences must be weighed. For example, there are a number of implementation issues that must be considered in determining the strengths and weaknesses of the organizational options. These include: 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 due to disruptions, confusion and delay; and the impact on state, tribal and local food safety agencies and on other constituencies.
Options
A broad range of organizational options have been identified as well as a few options that will not be considered at this time and the rationale for that decision. The options are based on the NAS report Ensuring Safe Food from Production to Consumption, legislative proposals in 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 sources.
The options consider regulatory responsibilities for food safety, and in some cases food safety research and surveillance funded by the U.S. government. They were chosen to ensure breadth and examine the key variables described above. The major options represent a continuum from strengthening the current system, to consolidating specific overlapping functions, to designating a lead agency, to creating a consolidated agency for most or all food safety functions. Within the options, there are alternatives or sub-options; to some extent the options and sub-options represent a menu from which alternatives could be combined to create a strengthened food safety system to achieve the Strategic Plan's goals. Some of the options can be implemented within existing structures and with current legislation, while others may require legislation and/or reorganization. The options focus on organizational structures for the federal food safety system, and not on vertical integration of food safety, although which structures provide better integration with state, tribal and local food safety regulatory agencies will be considered in evaluating the options.
I. Coordinated Federal Food Safety System
This option would provide centralized executive leadership (including a "single voice" for food safety), and improved coordination to facilitate achievement of food safety and public health goals. There are alternative ways to accomplish this. The alternatives differ in terms of the nature of the executive leadership as well as whether there is coordination and oversight of not only planning, budgeting and research, but also policy and/or operations. The option assumes development of a comprehensive federal food safety Strategic Plan and unified annual budgets. The Joint Institute for Food Safety Research (JIFSR) would initially coordinate microbial research, and could coordinate other food safety research in the future. There would be no organizational changes with this option. It could be implemented alone or in combination with Option II, some Lead Agency alternatives under Option III, or the less expansive forms of a consolidated agency in Options IV and V.
II. Specific Consolidations of Food Safety Functions
This option would consist of streamlining or consolidating specific federal food safety functions, particularly those where there are jurisdictional overlap, perceived duplication, or public confusion, in order to more efficiently achieve the goals of the Strategic Plan. In this option, full responsibility for certain food products or for specific points in the farm-to-table chain would be housed in one place within an existing organization. The option would also examine agency programs where there may be functional overlaps that cause confusion for the public or industry. Such streamlining has already been initiated for seafood with the Administration proposal to consolidate federal seafood inspection activities by transferring the National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program from DOC to FDA.
Examples of areas which might be examined for the possibility of streamlining or consolidation include:
An in-depth analysis could result in specific areas being consolidated (e.g., oversight of all meats with USDA; all federal guidance for retail food operations with DHHS), or food safety responsibilities for certain points in the farm-to-table chain being placed with one agency (such as discussed in the Egg Action Plan regarding packer/distributors).
III. Lead Agency Approach
As in Option I, the Lead Agency Approach provides centralized executive leadership and a "single voice" for all or discrete parts of the food safety system. It differs from Option I in that one agency becomes the lead for all or for specific food safety functions rather than vesting the "single voice" for food safety in a Council or Joint Chiefs. This option could be implemented in combination with Option II and the Canadian Model might also be combined with Option I.
IV. Consolidated Agency within Existing Department/Organization
This option would consolidate most food safety regulatory functions--i.e., policy, guidance, standard setting, inspection, enforcement, and education--in one agency reporting to either a current Cabinet Secretary, or the management of an existing independent agency. The consolidated agency would be responsible for standard setting, food safety labeling, education, information dissemination, inspection, enforcement, and coordination of outbreak response for all foods and substances in food. This consolidated agency would also oversee research and surveillance conducted by DHHS, USDA, and others. A variation on this would consolidate only USDA and DHHS regulatory functions -- i.e., it would exclude pesticide licensing and tolerance setting.
V. New Consolidated, Stand Alone Food Safety Agency
Different from Option IV which consolidates food safety functions within an existing organization, this option would create a new stand alone Cabinet-level food safety agency to facilitate achievement of food safety and public health goals. It would create an agency with its own executive leader or Cabinet-level Administrator (analogous to EPA or FEMA). Alternatively, the new agency could be managed by a five or seven member Presidential-appointed, Senate-confirmed Commission, with a Chairman who manages the day-to-day business of the Agency.
There are many ways to design a new stand-alone food safety agency. The following alternatives for a separate, stand alone agency take a functional approach. The first sub-option reflects an agency focused on a single function (inspections). With each subsequent sub-option, additional functions are added until all functions related to food safety are consolidated within one agency.
Alternatively, a new, stand alone agency could be formed on the basis of: 1) specific types of foods (all meats, all produce); 2) specific points in the farm-to-table spectrum (production, processing, etc.); or 3) different types of risks (microbial, chemical). Given the integrated nature of the food industry and food consumption as well as the fact that all types of hazards may be present in food products, these alternatives were not outlined for further analysis.
AFTERWORD
This draft plan and the public meeting on January 19, 2000, are intended to focus the public discussion on important food safety issues and their solutions. At the meeting, discussion will be facilitated by the questions which appear on page 1 of this document. To provide an opportunity for participation in writing, the agencies have established public dockets for the President's Council on Food Safety Strategic Plan. Comments should be submitted by February 14, 2000. It is important that comments submitted to the dockets are identified with the appropriate docket number. For those comments directed to USDA, use Docket No. 98-045N; for comments directed to FDA, use Docket No. 97N-0074; and for EPA, use Docket No. OPP-00550. Commenters are encouraged to submit a disk with their written comments in WordPerfect 6.1/8.0 or ASCII file format. Submit written comments (in triplicate) to: USDA/FSIS Hearing Clerk, 300 12th St., SW., Rm.102 Cotton Annex, Washington, DC 20250-3700; FDA/Dockets Management Branch (HFA-305), 5630 Fishers Lane, Rm.1061, Rockville, MD 20852. Comments may also be submitted electronically to: oppts.homepage@epa.gov. All comments and data in an electronic format must be identified by the docket number OPP-00550. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption.
Following the public review of this draft, the Strategic Plan will be refined. The final plan will include an examination of whether organizational, statutory, or other changes can contribute to implementation of the plan and achievement of the goals.
