EXECUTIVE SUMMARY
On July 3, 1998, President Clinton directed the Department of Health and Human Services (DHHS) and the Department of Agriculture (USDA) to develop a plan to create a Joint Institute for Food Safety Research (the Institute or JIFSR) and to issue a report within 90 days. The Institute is to (1) coordinate planning and priority setting for food safety research among the two Departments, other government agencies, and the private sector and (2) foster effective translation of research results into practice along the farm-to-table continuum.
The ultimate goal of the Institute is to coordinate food safety research, such that the incidence of foodborne illness is reduced to the greatest extent feasible. The result of the these coordinated and expanded efforts will be the more efficient delivery of the scientific information needed to develop effective food safety guidance, policies, and regulations in support of public health goals.
DHHS and USDA will have joint leadership of the Institute and will use existing resources to support it. This acknowledgment of the critical need to expand and coordinate food safety research also emphasizes the companion needs to expand and strengthen public-private partnerships and to augment collaboration among state, local, and other Federal agencies, thereby effectively providing the scientific information required to help achieve public health goals. As the scope of research activities is expanded, it may be appropriate to reconsider the structure and leadership of the Institute.
This document articulates the concept of the Institute, describes goals and the administrative principles underlying its organization, presents a proposed structure for the Institute, and a draft time line for its implementation. Appendices A through E provide, respectively, the Presidential Directive for the Institute, the Executive Summary from the May 1997 Food Safety Initiative Report to the President, the Executive Order creating the President's Council on Food Safety, a listing of the 12 Federal Agencies involved in food safety, and a glossary of acronyms. These materials will help define the history of Executive Branch Directives on food safety and the interagency consultative efforts that have contributed to the establishment of the Institute.
I. INTRODUCTION
On July 3, 1998, President Clinton directed the Secretary of Health and Human Services and the Secretary of Agriculture to report back to him within 90 days on the creation of a Joint Institute for Food Safety Research ("Institute"). As determined by the President, the Institute will:
"(1) develop a strategic plan for conducting food safety research activities consistent with [the President's National] Food Safety Initiative; and
(2) efficiently coordinate all Federal food safety research, including with the private sector and academia."
The Secretary of Health and Human Services and the Secretary of Agriculture will jointly lead the Institute, which will cooperate and consult with all interested parties, including other Federal agencies and offices -- such as the Environmental Protection Agency, the National Partnership for Reinventing Government, and the Office of Science and Technology Policy -- as well as State and local agencies focusing on research and public health, and consumers, producers, industry, and academia. As the scope of research activities is expanded, it may be appropriate to reconsider the structure and leadership of the Institute.
This document articulates the concept of the Institute and presents its proposed structure, operating principles, goals, and implementation schedule.
The ultimate goal of the Institute's research agenda is to reduce the incidence of adverse human health effects associated with the consumption of food. The objective of creating the Institute -- and all other Administration food safety activities -- is to protect public health by reducing the incidence of foodborne illness to the greatest extent feasible. Scientific information about the prevention of foodborne illness and detection of pathogens and other foodborne hazards is critical to reduce further the incidence of foodborne illness.
On October 1, 1998, the Secretary of Health and Human Services and the Secretary of Agriculture issued a report to President Clinton on the creation of a Joint Institute for Food Safety Research. The report was published in the Federal Register for comment in 1998 and a public meeting was held in December, 1998. A detailed draft proposal, based on the public comments received, was developed in January, 1999. The proposal has also been reviewed by the National Science and Technology Council of the Office of Science and Technology Policy (NSTC/OSTP). This final report, which will serve as the detailed blueprint for the Institute, will be published in the Federal Register in July 1999.
II. BACKGROUND
The National Food Safety Initiative
In his January 25, 1997, radio address, President Clinton announced he would request $43.2 million in his 1998 budget to fund a nationwide early-warning system for foodborne illness, increase seafood safety inspections, and expand food safety research, training, and education. The President directed three Cabinet members -- the Secretary of Health and Human Services, the Secretary of Agriculture, and the Administrator of the Environmental Protection Agency (EPA) -- to identify specific actions to improve the safety of the food supply. He further directed them to consult with stakeholders (consumers, producers, industry, States, universities, and the public) and to report back to him within 90 days. The President emphasized the need to explore opportunities for public-private partnerships to improve food safety, particularly in the areas of surveillance, inspections, research, risk assessment, education, and coordination among local, State, and Federal health authorities. Through a series of interagency and stakeholder meetings and consultations, the May 1997 Report to the President entitled "Food Safety from Farm to Table: A National Food Safety Initiative" was developed and issued. (See Appendix B.)
Although the American food supply is among the safest in the world, the Administration called for the National Food Safety Initiative (FSI) because every year millions of Americans continue to experience illness caused by the food they eat. The FSI recognized that research provides new information and technologies essential to successful implementation of five key activities: standard setting and rulemaking, inspection and compliance, education, surveillance, and risk assessment. For his Fiscal Year 2000 budget, President Clinton requested an increase of $72 million in support of the FSI. To ensure that current research investments are adequately supporting the five key activities identified by the FSI, Federal research agencies are working on a coordinated, interagency research plan. Federal agencies that conduct food safety research have recently completed a major step in the development of this plan by creating a Federal inventory of food safety research projects, active or planned, for Fiscal Year 1998, including the scientific and fiscal resources that support the research. DHHS, USDA, EPA, and other food agencies--in collaboration with NSTC, and the Office of Science and Technology Policy (OSTP), Executive Office of the President, will use this information to identify additional priority food safety research areas that are not currently addressed in the FSI and will develop future food safety initiatives and their budgetary requirements for consideration by the Office of Management and Budget.
The FSI identified five broad areas in which significant knowledge gaps require a concerted interagency research effort:
The FSI also identified, as a research goal, the development of methods and scientific data that would enhance the ability of Federal agencies to conduct microbial risk assessments. Two additional research areas, critical to reaching this goal, are:
When the FSI was developed in 1997, these immediate needs were given priority within the research and risk assessment agenda because foods contaminated with pathogens have been linked to increasing incidence of foodborne illness and to high rates of morbidity and mortality. As these research and risk assessment activities progress and improvements in preventative measures are developed, the Institute will provide leadership for identification of other research and risk assessment priorities, which will receive increased attention from Federal food safety agencies in future years.
III. STRUCTURE AND OPERATION OF INSTITUTE
The Institute will report to The President's Council on Food Safety (see Appendix C), which is chaired by the Secretaries of Agriculture and Health and Human Services and the Assistant to the President for Science and Technology/Director of the Office of Science and Technology Policy. The Institute will be included within the Council's budget process. The Institute will be led by an Executive Director who will supervise the day to day management and provide leadership in communicating the vision of the Institute. In order to expedite the recruitment of a nationally known expert in food safety research, the first Executive Director of the Institute will be recruited for a period of up to two years using an Intergovernmental Personnel Act (IPA) arrangement. A search committee with representatives of DHHS, USDA, and OSTP will solicit applicants, review the candidates' qualifications and make recommendations on the top three candidates. This process will begin in July, 1999, with the goal of having the Executive Director in place by late fall, 1999.
The Institute will be established through a cooperative agreement entered into between USDA and DHHS under the authority of section 1472(b) of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3318(b)). Under the terms of the cooperative agreement, the Executive Director will supervise a small institute staff of no more than 10 employees. USDA and DHHS shall contribute (a) the Executive Director, who will be under appointment to one of the Departments, (b) all additional staff, which will consist solely of full-time USDA and DHHS employees who are assigned to the Institute, and (c) administrative and operational expenses. Three professional staff members will be recruited from DHHS and USDA to complete the scientific expertise of the Institute. These three staff will function as program and risk analysts, coordinators, planners and communicators. They will have broad knowledge of their Department's relevant programs, both research and regulatory, in the area of food safety. The Executive Director may also choose to select staff who have expertise in specific scientific areas.
In addition to the professional staff, two staff from within USDA and DHHS will be identified to provide administrative and secretarial support and budget analysis; other existing staff resources will also support the operations of the Institute. All staff will be located in a facility in close proximity to USDA and DHHS in downtown Washington, D.C. Financial responsibility for the Institute will be shared between USDA and DHHS under the cooperative agreement whereby each Department will have responsibility for a maximum of two years at a time. Ad Hoc Task Forces will be convened as special technical needs arise. The task forces will be comprised of individuals from agencies with relevant research or regulatory expertise on the given problem. It is anticipated that any Ad Hoc Task Force would operate for less than one year or until the need it was formed to address is fulfilled.
The Secretary of Agriculture is required by Section 615 of the Agricultural Research, Extension and Education Reform Act to create a Food Safety Information Office at the National Agricultural Library; one of the main functions of this office will be to develop and maintain a food safety research database. This database will be important to the on going operations of the Institute. While the Food Safety Information Office will not report directly to the Institute, coordination and communication of activities is essential.
The Institute will provide reports to the Federal Policy and Budget Committee, comprised of Federal food safety policy officials and agency heads, representing both research agencies and regulatory agencies. Its membership will represent agencies of the USDA, DHHS, the Environmental Protection Agency, the National Science Foundation, and other relevant Federal agencies. The Policy and Budget Committee will be the vehicle for consultation and coordination across all Federal food safety agencies, including activities such as annual budget development. It is expected that the Policy and Budget Committee will meet quarterly.
The Council shall name an Executive Research Committee comprised of three senior research officials from among the Federal Policy and Budget Committee members. Specifically, these officials shall represent the White House Office of Science and Technology Policy, the USDA Under Secretary for Research, Education and Economics and the Department of Health and Human Services Science Advisor. The Executive Committee will provide direct oversight to the Institute's Director. The Executive Research Committee shall be chaired by the USDA representative during such time as the Institute Executive Director is under a DHHS IPA and vice versa.
The Institute will also be advised by the Joint Institute for Food Safety Research Advisory Committee, which will have 16 stakeholder members (8 members appointed by the Secretary of Agriculture and 8 members appointed by the Secretary of Health and Human Services). Thus Advisory Committee shall meet twice a year Members of this committee may be chosen from existing advisory committees to the USDA, DHHS, and OSTP.
The Institute will focus initially on food-borne illness caused by microbial pathogens, microbial toxins and antimicrobial resistance, in keeping with the President's National Food Safety Initiative. In future years, based on the direction of the President's Food Safety Council, advice of the Joint Institute for Food Safety Research Advisory Committee, and on other public input, the Institute may expand its scope progressively to include other known or potential contributors to foodborne illness and/or food safety, such as chemical contaminants, natural toxins, pesticide residues, animal drug residues, and food ingredients. All of these topics already are foci for important food safety research activities that warrant coordination by the Institute. With this scope, the Institute would develop broad-based strategic planning with input from stakeholders and coordinate the resources administered by the numerous Federal agencies that participate in food safety research. (See Appendix D.)
Budget
The estimated total annual cost for operation of the Institute is $1,000,000. These costs will be covered on the basis of contributions of staff and expenses by USDA and DHHS under the terms of the cooperative agreement. Approximately $700,000 of that amount will be in-kind contributions in the form of assigned staff and $200,000 for operations, including equipment, telecommunications, travel, space and supplies. An additional $100,000 will be required to fund the two meetings per year of the Advisory Committee. The operations and funding of the Advisory Council will alternate on a yearly basis between USDA and DHHS. In the long-term, the departments will seek legislative approval to allow other options for funding of the Institute and the Advisory Committee.
Recruitment of the Executive Director will commence upon signing the Cooperative Agreement.
IV. ORGANIZING PRINCIPLES
DHHS and USDA have developed the following principles as the foundation for establishing and operating the Institute.
A. Optimize Current Investment and Infrastructure
The Institute's mission includes optimizing the effectiveness of current food safety research investments and infrastructure to maximize funds going to conduct research, rather than for construction or maintenance of additional research facilities. For this reason, the President's directive is not intended to result in construction of new research or administrative facilities. The Institute will focus on coordinated planning for research programs and budgets and on enhanced communications among existing organizational entities working within existing facilities. The Institute will be supported by a small staff and will draw on current resources within the responsible food safety agencies.
B. Provide Centralized Communication with Stakeholders
Effective communication between the Federal agencies that conduct food safety research and the users of the knowledge gained is critical to establishing priority-based research programs that are responsive to national needs. More than a dozen Federal agencies actively contribute to food safety research efforts. Food safety researchers have numerous critical constituencies: (1) regulatory agencies that rely on scientific information for the protection of public health; (2) industry and producers, including retailers, who design and implement effective food safety programs; and (3) consumers. While each agency makes a critical contribution, providing their unique expertise, perspective, and infrastructure, this array of activities can be daunting to stakeholders. Effective interchange -- not only among Federal laboratories and the managers of Federally supported extramural research programs, but also their counterparts in industry and academia -- is critical to developing cost-effective programs that maximize the benefits to public health. Therefore, the Institute will serve as a centralized focal point for communication between stakeholders and the appropriate members of the Federal research community by facilitating public input into priorities through public meetings and advice from the Joint Institute for Food Safety Research Advisory Committee.
C. Use Current Intramural and Extramural Research Programs in Innovative Ways
Leveraging Federal research dollars for maximum public health benefit is critical to effective implementation of the FSI farm-to-table strategy. To better leverage current and future funds, the Institute will foster development of joint program announcements involving multiple Federal research programs and multi-center trials to demonstrate the cost-effectiveness of prevention strategies and technologies.
D. Mobilize Resources to Minimize the Impact of Current and Emerging Food Safety Problems
Food safety problems are usually complex, involving the interaction of factors associated with public health, agricultural productivity, food processing and distribution practices, market economies and international trade, and consumer preferences and perceptions. The research needed to solve these problems is equally complex, requiring contributions from both basic and applied researchers in physical and biological sciences, equally important advances in economic and behavioral research, and innovations in food technology and engineering. The impact of new food safety problems related to threats to public health and the economic well-being of the nation is often dependent on how rapidly research resources can be mobilized. In the absence of a centralized coordinating mechanism to provide leadership, such as the Institute, the timely mobilization of resources among diverse groups of scientific disciplines has historically been a barrier to effective problem identification and resolution. This barrier is of particular concern to food safety regulatory agencies. The Institute, through advanced communications and coordination systems, will realize increased efficiencies in bringing to bear research resources when they are needed to minimize the impact of current and emerging food safety problems.
E. Increase Accountability for Federal Research Priorities and Implementation of Strategies to the Public
One of the Administration's highest priorities has been to make Federal agencies more responsive to the needs of the nation through transparent decision-making. To effectively manage the nation's food safety research needs, the Administration to date has focused on joint research planning and prioritization, with the participation of numerous Federal agencies. Establishment of the Institute will build on this planning process, thereby increasing the transparency of Federal food safety research efforts, to better assure the public that Federal investments are strategic and not redundant.
V. GOALS OF THE INSTITUTE
A. Coordination in Research Planning, Budget Development, and Prioritization
The ultimate goal of the Institute's research agenda is to reduce the incidence of adverse human health effects associated with the consumption of food. Research planning, budget development, and prioritization will be a consultative process among food safety research and regulatory agencies, with a primary purpose being to fulfill the informational needs of food safety regulatory agencies. As stated above, DHHS and USDA will cooperate to lead this effort, in consultation with OSTP and other interested Federal agencies and offices. The goals of this effort are: (1) to maximize the public health benefit to the American people for resources devoted to basic and applied research, by assuring that the information acquired is applicable to the development of effective food safety guidance, policy, and regulation; (2) to maximize the return-on-investment to producers, processors, and the public for resources devoted to research by developing cost-effective prevention technologies; (3) to effectively communicate and operate together with Federal, state, and local public health, agriculture and research agencies and Government partners; and (4) to develop partnerships among the Federal, State, and local Governments and industry or academia to identify and solve, scientifically, food safety issues. The Institute will assist the President's Council on Food Safety, as appropriate, coordinating research and development of budgets for submission to OMB as part of the Administration-wide Food Safety Initiative. The Institute also will coordinate and monitor agency activities to further these goals and to provide periodic assessments of research accomplishments.
B. Scientific Support of Food Safety Regulation
The Nation's collective food safety research capabilities must be responsive to the risk-based public health priorities of the food safety regulatory agencies. Science and technology are required to develop effective food safety guidance, policy, and regulation. The Institute will identify research needs to: (1) achieve public health goals; (2) support guidance, pathogen reduction regulation, and hazard analysis and critical control points (HACCP) approaches to regulation (e.g., meat, poultry, seafood, fresh juice), and compliance strategies; (3) shift research orientation to a risk-based approach; and (4) other relevant areas as the scope of coordinated research is expanded progressively to include chemical contaminants, pesticide residues, animal drug residues and food additives. Through the Federal policy and budget committee, which advises the Institute's Executive Director, food safety regulatory agencies will play an integral role in the Institute's operation and its development of research strategies to foster public health goals.
C. Communication/Links with Other Food Safety Agencies
Through participation in the Institute, all Federal food safety research agencies will coordinate, complement, and bolster research efforts on related and multifaceted food safety issues. The Institute will coordinate the use of existing mechanisms, such as interagency agreements, and contracts; the development of scientific conferences; the development of new mechanisms, such as jointly funded program announcements; and other innovative approaches to further the achievement of the Institute's goals.
D. Communication/Links with Industry and Academic Partners
The Institute will advocate the development of public-private partnerships with industry and academia to efficiently develop and transfer new information and technologies. Technology transfer mechanisms for cooperation between Federal agencies and industry exist through the Cooperative Research and Development Agreement (CRADA) process. This mechanism protects the intellectual property rights of the parties involved and is designed to avoid conflicts of interest, which are of particular concern within regulatory agencies.
Several food safety research consortia, which include Federal, state, academic, and industry partners, already exist and are supported in part through competitively awarded Federal extramural research grants. These institutes can optimize and combine resources to perform stronger and more cost-effective research programs in food safety than can a single entity. The USDA and DHHS research agencies expect to continue using grants, contracts, and cooperative agreements in partnership with academia.
VI. IMPLEMENTATION SCHEDULE
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October 1998 | Announced report in Federal Register for comment and notice of public meeting |
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December 1998 | Hosted public meeting |
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January 1999 | Analyzed comments and developed a more detailed proposal for the Institute |
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June 1999 | Submitted proposal to National Science and Technology Council for review |
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July 1999 | Announce final report in the Federal Register |
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October 1999 | Recruit Executive Director for the Institute and identify members of the Joint Institute for Food Safety Research Advisory Committee Members of the Advisory Committee are appointed by the Secretary of Health and Human Services and Secretary of Agriculture and Office of Science and Technology Policy |
APPENDIX C - EXECUTIVE ORDER: PRESIDENT'S COUNCIL ON FOOD SAFETY, AUGUST 25, 1998
APPENDIX D
Federal Food Safety Agencies
Fourteen Federal agencies have food safety responsibilities:
Agricultural Marketing Service, (AMS), U.S. Department of Agriculture (USDA)APPENDIX E
Glossary of Acronyms
AMS Agricultural Marketing Service