Executive Summary
I. Introduction
II. Background
III. Structure of the Institute
IV. Organizing Principles
V. Goals/Outcomes of the Institute
VI. Implementation Schedule
Appendices
B. Executive Summary, President Clinton's National Food Safety Initiative, May 1997
C. Executive Order: President's Council on Food Safety, August 25, 1998
D. Federal Agencies with Research and Risk Assessment Responsibilities
EXECUTIVE SUMMARY
On July 3, 1998, President Clinton directed the Department of Health and Human Services (DHHS) and the Department of Agriculture (USDA) to report back within 90 days with a plan to create a Joint Institute for Food Safety Research ("the Institute"). 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. Enhanced and more efficient national investment in food safety research will do much to lower incidence of foodborne illness in the United States.
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 providing effectively the scientific information required to help achieve public health goals.
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. Enhanced and more efficient food safety research will do much to meet the needs of Federal food safety regulatory agencies.
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.
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"). 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."
As the President's memorandum directed, 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. The Institute will make efforts to build on ongoing private sector research, through the use of public-private partnerships and other appropriate mechanisms.
This document articulates the concept of the Institute and provides a proposed structure, operating principles, goals and outcomes, and an implementation schedule for the Institute.
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 reduce the incidence of foodborne illness to the greatest extent feasible. Scientific information about prevention of foodborne illness and detection of organisms that may cause it is critical to further reduce the incidence of foodborne illness.
This report will serve as a starting point for development of the Institute. The report will be published in the Federal Register for comment during October/November of 1998 with a public meeting in November/December of 1998. A detailed draft proposal, based on the public comments received, will be developed by January of 1999. The final proposal will be submitted to the National Science and Technology Council of the Office of Science and Technology Policy (NSTC/OSTP) in March 1999 for final review. A final report, which will serve as the detailed blueprint for the Institute, will be announced in the Federal Register in April of 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 in 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 1999 budget, President Clinton requested an increase of $101 million in support of food safety activities. This request is currently under consideration by Congress. 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 and USDA, in collaboration with NSTC/OSTP, 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:
- Improving detection methods;
- Understanding microbial resistance to traditional preservation technologies;
- Understanding antibiotic drug resistance;
- Developing prevention techniques for pathogen avoidance, reduction, and elimination; and
- Understanding the contribution of food handling, distribution, and storage to pathogen contamination of food and developing preventions.
The FSI also identified the research goal to develop methods and scientific data that would enhance the ability of Federal agencies to conduct microbial risk assessments. Two additional research areas, critical for addressing this goal, are:
- Developing and validating microbial exposure models, based on probabilistic methodology; and
- Developing and validating dose-response assessment models for use in risk assessment.
When the FSI was developed in 1997, these immediate needs were given priority within the research and risk assessment agenda because microbial contamination of foods by pathogens has increasingly 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 research agencies in future years.
III. STRUCTURE OF INSTITUTE
The Institute will report to The President#146;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 led by an Executive Director, who will be a highly recognized food safety scientist, jointly recruited, appointed, and supported by the USDA and DHHS. The Executive Director will supervise a small, permanent Institute staff of no more than 10 employees, and existing staff resources of USDA and DHHS will support the Institute and its operations.(1)
The Executive Director will report to an Executive Research Committee, and the Executive Research Committee will report to the President's Council on Food Safety. The Executive Research Committee will comprise three senior research officials appointed by of the three co- chairs of the President's Council on Food Safety. The Executive Director will facilitate the work of the Federal budget and policy committee, which will be chaired by the Executive Research Committee.
The Federal policy and budget committee will be comprised of Federal food safety policy officials and agency heads, representing both research agencies and regulatory agencies, and its membership will represent agencies of the USDA, DHHS, the Environmental Protection Agency, the National Science Foundation, and other relevant Federal agencies. This Federal policy and budget committee will serve as a mechanism by which the Government's chief scientific and public health experts can interact with the Executive Director and the Executive Research Committee to ensure the goals of the Institute are achieved. This committee also will be the vehicle for consultation and coordination across all Federal food safety agencies, including activities such as budget development for submission to OMB.
The Executive Director will be advised by the Joint Institute for Food Safety Research Advisory Committee, which will have 16 stakeholder members (6 members appointed by the Secretary of Agriculture, 6 members appointed by the Secretary of Health and Human Services, and 4 members appointed by OSTP/NSTC). Members of this committee may be chosen from existing advisory committees to the USDA, DHHS, and OSTP/NSTC. USDA, DHHS, and OSTP/NSTC will jointly support the Advisory Committee.
The work of the Institute will be accomplished through temporary interagency task forces that form and close as specific issues are resolved and through a small, permanent Institute staff, which will provide technical, administrative, clerical and computer support. The Institute will focus initially on microbial pathogens, 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, food additives, and nutrition. 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.)
IV. ORGANIZING PRINCIPLES
The 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. The Institute will assist in fulfilling the Administration's farm-to-table strategy by relying on access to existing Federal research laboratories throughout the country.
B. Provide Centralized Communication with Stakeholders
Effective communication between the Federal food safety research providers 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. Particular emphasis will be placed on "on-farm" research for the development of new technologies and tools to prevent microbial contamination of raw foods.
D. Mobilize Resources to Minimize the Impact of Current and Emerging Food Safety Problems
Food safety concerns are usually complex, involving the interaction of factors associated with agricultural productivity, public health, food processing and distribution practices, market economies and international trade, and consumer preferences and perceptions. The research needed to solve food safety 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 industry, 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 encompass 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/OUTCOMES 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 the National Science and Technology Council of the Office of Science and Technology Policy (NSTC/OSTP) and other interested parties, including other 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 not only develop coordinated budgets for submission to OMB, but also it 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) systems approaches to regulation (e.g., meat, poultry, seafood, fresh juice), and compliance strategies; and (3) shift research orientation to a risk-based approach. Through the Federal policy and budget committee, which advises the Institute 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, contracts, and the development of scientific conferences, and 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 encourage 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. The Institute will foster and build on existing technology transfer mechanisms.
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 will continue to use grants, contracts, and cooperative agreements in partnership with academia.
VI. IMPLEMENTATION SCHEDULE
October/November 1998 Announce report in Federal Register for comment and notice of public meeting
November/December 1998 Host public meeting
January 1999 Analyze comments and develop a more detailed proposal for the Institute
March 1999 Submit proposal to National Science and Technology Council for review
April 1999 Announce final report in the Federal Register
May 1999 Recruit Executive Director for the Institute and Joint Institute for Food Safety Research Advisory Committee Members are appointed by Secretary of Health and Human Services and Secretary of Agriculture and Office of Science and Technology Policy
A. PRESIDENT CLINTON'S MEMORANDUM FOR THE SECRETARY OF HEALTH AND HUMAN SERVICES AND THE SECRETARY OF AGRICULTURE, JULY 3, 1998
APPENDIX B - FOOD SAFETY FROM FARM TO TABLE: A NATIONAL FOOD SAFETY INITIATIVE REPORT TO THE PRESIDENT MAY 1997 EXECUTIVE SUMMARY
APPENDIX C - EXECUTIVE ORDER: PRESIDENT'S COUNCIL ON FOOD SAFETY, AUGUST 25, 1998
APPENDIX D
Twelve Federal agencies have food safety responsibilities:
- Agricultural Marketing Service, (AMS), U.S. Department of Agriculture (USDA)
- Animal and Plant Health Inspection Service, (APHIS), USDA
- Agricultural Research Service (ARS), USDA
- Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS)
- Cooperative State Research, Education, and Extension Service (CSREES), USDA
- Economic Research Service, (ERS), USDA
- Environmental Protection Agency,(EPA)
- Food and Drug Administration, (FDA),DHHS
- Food Safety and Inspection Service,(FSIS), USDA
- Grain Inspection, Packers and Stockyards Administration, (GIPSA), USDA
- National Institutes of Health, (NIH), DHHS
- National Marine Fisheries Service (NMFS), Department of Commerce
APPENDIX E
AMS Agricultural Marketing Service
APHIS Animal and Plant Health Inspection Service
ARS Agricultural Research Service
CDC Centers for Disease Control and Prevention
CRADA Cooperative Research and Development Agreement
CSREES Cooperative State Research, Education, and Extension Service
DHHS Department of Health and Human Services
EPA Environmental Protection Agency
ERS Economic Research Service
FDA Food and Drug Administration
FSI National Food Safety Initiative
FSIS Food Safety and Inspection Service
GIPSA Grain Inspection, Packers and Stockyards Administration
HACCP Hazard Analysis Critical Control Points
JIFSR Joint Institute for Food Safety Research
NIH National Institutes of Health
NMFS National Marine Fisheries Service
NPR National Performance Review
NSTC/OSTP National Science and Technology Council/Office of Science and Technology
OMB Office of Management and Budget
USDA U.S. Department of Agriculture
This is a mirror of the Joint Institute for Food Safety Research Report to the President, October 1, 1998 from CSREES.