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Executive Summary | Table of Contents | Research Projects | Appendices
Food safety practices and programs must be based on sound science to effectively prevent or control the occurrence of microbial pathogens and their toxic metabolites in food and respond efficiently to foodborne disease outbreaks. During the development of the interagency Food Safety Initiative (FSI) Report to President Clinton in fiscal year 1997 (FY97) and the Produce and Imported Foods Safety Initiative (PIFSI) research needs document in FY98 (see http://www.cfsan.fda.gov), the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) identified priority regulatory research efforts to support its mission. The resulting research focus was used to: (a) review CFSAN's current overall research and risk assessment activities; (b) redirect and/or accelerate produce research impacting microbiological safety; and, ultimately, (c) develop a consolidated three-year research plan for FSI/PIFSI. The latter was issued May 1, 1998, with planned annual reviews and updates. The document presented below, developed after CFSAN internal review, is the first update of that original research plan. In addition to examining the quality of science and progress made on the projects described in the FY98 plan, CFSAN also reviewed those efforts against updated mission-oriented research needs (see Appendix A). This process resulted in further redirection of certain projects and acceleration of priority research, through increased support of selected ongoing studies and/or initiation of new studies (i.e., components) within existing projects. Also, the format of project presentation was altered to: (a) facilitate tracking by and reporting to CFSAN's Office of Management Systems (OMS); (b) identify Government Performance and Results Act (GPRA) goal activity; and (c) indicate relevance to CFSAN's Program Priorities and Regulatory Research Needs.
Introduction:
THE CFSAN FSI STAFF
The FDA, in concert with other Executive Branch food safety agencies, has been charged in the FSI with identifying specific steps to ensure the safety of the United States food supply. The FSI has focused on developing a nationwide early-warning system for foodborne illness, increasing seafood safety inspections, and expanding food safety research, training, and education and, in 1999, is directing increased attention to inspections of imported foods and produce. The CFSAN FSI staff, lead by the FSI Director, and with the cooperation of CFSAN ORA and CVM, has coordinated the development, implementation, and performance of CFSAN's portion within FDA of the FSI. This staff's functions include research, surveillance, risk assessment, education, and inspection and compliance.
Food safety research is critically needed to develop the means to identify and characterize more rapidly and accurately foodborne hazards, to provide the tools for regulatory enforcement, and to develop effective interventions that can be used, as appropriate, to prevent hazards at each step in production and distribution prior to consumption. CFSAN conducts research related to pathogenic microorganisms and other contaminants that threaten the safety of food. This research supports the needs of the Federal and state food safety agencies and the many food industries. The CFSAN FSI Research/Risk Assessment Office is responsible for planning, coordinating, and evaluating CFSAN's food safety research programs, to ensure that these endeavors adequately and properly meet the requirements of the President's FSI in the FDA. The CFSAN FSI Research/Risk Assessment Office also serves as the focal point for coordinating CFSAN's food safety research programs with those of other FDA Centers and Federal agencies, academia, and private industry.
BACKGROUND
In response to concerns that the incidence of foodborne disease is increasing, the President directed the implementation of two multiple-agency initiatives during 1997-- FSI and PIFSI. One of the key components of both FSI and PIFSI is the focusing of food safety research efforts and resources on gaps in knowledge that limit our ability to effectively assess and assure the safety of the United States food supply. Integral to this effort is an increased level of interagency research coordination, communication, and cooperation to eliminate unplanned redundancies of effort. The President's Council on Food Safety, chaired by the Secretary of Health and Human Services, the Secretary of Agriculture, and the Assistant to the President for Science/Director of the Office of Science and Technology Policy is responsible for development of a strategic plan to protect public health through improved Federal food safety systems. Two of the key areas in that plan are research and risk assessment. The establishment during FY98 of an interagency Risk Assessment Consortium/Clearinghouse (the Consortium will collectively work to enhance communication and coordination between federal agencies and promote the conduct of scientific research that will facilitate risk assessments; the Clearinghouse will identify and catalogue risk assessment methods, models, and data sets, and will be easily accessible) and the planned implementation in FY99 of the Joint Institute for Food Safety Research (JIFSR) (the Institute will coordinate Federal food safety research efforts, including priority-setting and budget submissions) reflects the emphasis on a sound scientific basis for national food safety efforts. These entities also reflect the acknowledged need for participation by government, academia, industry, public health professionals, and consumers to achieve the overall FSI goal of improved public health through reduction of foodborne illness.
The FDA is the primary federal public health agency responsible for assuring the safety of the nation's food supply. It shares this responsibility with the Department of Agriculture's Food Safety and Inspection Service (USDA/FSIS), which regulates meat, poultry, and certain egg products. Research in food safety within FDA is conducted by CFSAN, the Center for Veterinary Medicine (CVM), the National Center for Toxicological Research (NCTR), and the Office of Regulatory Affairs (ORA). Research at CFSAN supports regulatory activities critical to carrying out the Center's mission of public health protection. These activities include: (a) the development of food safety policies, including regulations and industry and consumer guidance, that are based on detailed scientific knowledge and principles; (b) the development of tools for implementing and assessing the effectiveness of the Center's policies; and (c) responding rapidly to newly emerging food safety threats to public health.
Food safety practices and programs must be based on sound science to effectively prevent or control microbial pathogens and their toxic metabolites and respond efficiently to foodborne disease outbreaks. This science base, provided primarily by research, provides the foundation for all regulatory and other control programs. Detailed knowledge of the relevant characteristics of each pathogen (e.g., ecology, virulence factors, genetics, evolutionary potential, growth capabilities, and transmissibility) is needed to develop effective systems for their prevention and control. Scientific knowledge will provide a systematic approach (i.e., risk assessment) to evaluate commodities and their associated pathogens and toxins from initial production, through processing and consumption. Risk assessment further provides a means for elucidating major areas of uncertainty in scientific knowledge (or outright gaps), thus identifying priority research that can lead to the development of cost effective means for improving public health. Clearly, then, integration of research and risk assessment is fundamental to the development of prudent guidelines and regulations.
Identifying CFSAN Research Priorities:
Five broad areas in research and three broad areas in risk assessment development, where significant knowledge gaps or the lack of appropriate scientific data, methods, or models require a concerted interagency research effort, were identified in the FSI and affirmed under PIFSI:
RESEARCH
RISK ASSESSMENT
As in the development of the FY98 three year plan, research areas identified in conjunction with FSI/PIFSI have also been balanced to simultaneously address priority risk management issues at CFSAN. In conjunction with its review of the research projects in the FY98 plan, CFSAN also reexamined the specific regulatory issues and public health concerns initially identified as requiring research support. This reexamination of regulatory needs resulted in a list of risk management questions for which answers are needed to develop scientifically credible and effective policies, including regulations, standards, and guidance in specific priority areas (see Appendix A). This Regulatory Research Needs document was distributed to all of the Center's scientists, to researchers in other components in FDA, as well as to various organizations in the food safety community, including relevant Federal and state agencies, academic institutions, and other groups. In addition to the areas highlighted in the Regulatory Research Needs document, CFSAN also identified additional needs in several broad topic areas which USDA food safety research agencies appeared to be in the best position to address, because of their staffing, facilities or other resources.
Development and Updating of the Three-Year Research Plan
FY99's three-year research plan, like last year's, was developed in a transparent, stepwise fashion. First, the inventory of current and planned research projects in the FY98 plan was reviewed for overall conformance with the PIFSI directive to identify, accelerate, and coordinate research with other food safety agencies that will reduce microbial risks associated with fresh produce. Second, the projects were peer-reviewed for quality of the science. Last, but not least, each project was reviewed with regard to both the level of effort being focused on the research problem and progress toward the original objectives. As in the development of the FY98 plan, the goal was to dedicate sufficient resources to accomplish the specific objectives in approximately three years. Several smaller projects with similar research objectives were consolidated, while research efforts in areas of little progress or lower priority were redirected into higher priority areas.
Several additional key factors were considered during the review process. Core research support functions, such as electron microscopy, mass spectrometry, flow cytometry, pulse field gel electrophoresis, ribotyping, and animal care and use were identified. Current and planned purchases of both large capital equipment as well as smaller multiple-user items were prioritized and consolidated across similar projects.
Although highest priority has been given to the CFSAN projects that support the FSI/PIFSI, the Center has also factored into its research planning the need to maintain and enhance specific cross-cutting scientific capabilities and expertise in support of the overall research program (i.e., including nonFSI programs). In addition, CFSAN must maintain the ability to respond quickly and effectively to new public health concerns, including microbiological food safety concerns not currently on the horizon. During FY99, the Center plans to integrate the research planning and prioritizing of FSI projects and its other research efforts (e.g., dietary supplements, chemical contaminants, filth, food ingredients, nutrition and wholesomeness, cosmetics and colors safety).
As in the FY98 Plan, the researchers were again asked to develop projects based on the resources and expertise available. However, the identification of needed resources (personnel, equipment, supply and/or operational budget) that would facilitate or accelerate progress, especially in high priority areas, was encouraged. Consequently, this FY99 Plan serves as a planning document that identifies additional resources needed to optimize progress on projects that have been undertaken.
Moreover, a balanced research program that addresses both the intermediate and long term needs of CFSAN is required. Therefore, the majority of the research program in this three-year plan is designed to address CFSAN's regulatory research needs during the next three to five years. A portion of the effort is reserved for "exploratory research" that addresses potential food safety concerns that may arise during the next five to eight years.
Additional FSI/PIFSI Research Efforts
In the FY98 three-year research plan, CFSAN announced its intention to solicit extramural proposals in specific areas, with the goal of awarding between five and nine extramural grants. CFSAN solicited proposals in four broad areas: (a) research that will lead to the development of improved dose-response models for foodborne pathogens; (b) development of improved sampling methods for the detection of low levels of pathogenic biological agents in or on foods, particularly fresh produce; (c) development of new, non-thermal intervention techniques that can be employed by the consumer and food service operators to reduce the risk of exposure to pathogenic biological agents on foods, particularly fresh produce; and (d) elucidation of the genome sequence of those portions of Escherichia coli O157:H7 chromosome that are unique to this pathogenic serotype of a normally non-pathogenic species. During FY98, CFSAN awarded eight extramural grants based on competitive review of 19 proposals. These research projects are listed below, and more detailed descriptions are presented in Appendix B.
RISK ASSESSMENT GRANTS
RESEARCH GRANTS
Using the Three-Year Plan
Each of the research projects that have been initiated or are ongoing, under the auspices of CFSAN's FSI/PIFSI research and risk assessment activities, are listed in the following tables. Each entry provides a narrative description of the research area the project is intended to address, a series of "deliverables" that can serve as milestones for evaluating progress, and the resources devoted to each project. In addition, codes indicating the specific FSI/PIFSI focus and risk management needs addressed by each project are provided; likewise, codes that correlate each project with specific items in the FY99 CFSAN Program Priorities document are also provided. Finally, the administrative liaison(s), the research manager responsible for overseeing, coordinating, and reporting the activities associated with each project, is identified.
Any general questions concerning the research plan should be directed to R. L. Buchanan (202-205-5053), V. K. Bunning (202-205-5140), or the specific project Administrative Liaison.
CFSAN Regulatory Codes:
1.1 Imports
1.1a Foodborne outbreaks associated with imported food
1.1b Increase surveillance of imported food products at the border
1.1c Education/Outreach assistance to foreign countries on GAP/GMP
1.1d Evaluate food regulatory systems in foreign countries
1.1e Conduct 75-100 foreign inspections of food establishments
1.2 Hazard Analysis and Critical Control Points (HACCP)
1.2a Seafood HACCP
1.2b Juice HACCP
1.2c HACCP at Retail
1.3 Produce Initiative
1.3a Good Agricultural Practices
1.3b Sprouts
1.4 Additional Prevention Efforts
1.4a Citrus Juices
1.4b Apple Cider
1.4c Fresh Cut Produce
1.4d Prevention Measures for Eggs
1.4e Food Code
1.4f MOU with FSIS
1.4g Vibrio vulnificus
1.5 Surveillance and Outbreak Response
1.5a Outbreak Response
1.5b Foodborne Outbreak Response Coordinating Group (FORCG)
1.5c Listeria
1.5d Salmonella enteritidis
1.6 Research
1.6a Food Safety Initiative Research and Risk Assessment
1.6b Extramural Research
1.6c Consultation with USDA
1.6d Joint Institute for Food Safety Research
1.7 Risk Assessment
1.7a Listeria
1.7b Vibrio parahaemolyticus
1.7c Methylmecury
1.8 Education
1.8a Shell Eggs
1.8b Fight BAC
1.8c Food Safety Education Month
"B" List
1.9B Update on frequently asked seafood HACCP questions
1.10B HACCP template code of practice for fish products
1.11B Foster farm egg quality assurance programs
1.12B Technology Transfer
1.13B Risk Assessment Consortium (finalize charter and initiate implementation)
1.14B Risk Assessment Consortium Clearinghouse
1.15B Information Network
2.1 Premarket Review of Food Ingredients
2.1a Expedited Review
2.1b Food and Color Additives
2.1c GRAS Determinations
2.1d Indirect Food Additives
2.1e Irradiation Labeling
2.1f Food Quality Protection Act
"B" List (Premarket Review of Food Ingredients)
2.2B Food Additives - investigate additional procedures that impact on the
antimicrobial action against human pathogens in foods
2.3B Identify efficiencies/streamlining mechanisms for the food additive review process
2.4B Develop a strategy regarding the use of bromates in baking products
2.5B Complete an evaluation of the safety issues concerning Cochineal extract and carmine
color additives
2.6B Complete revision of two chapters of the new edition of the "Redbook."
2.7B FR Notice addressing labeling requirements for Olestra-containing products.
2.8B Develop guidance for the industry (enzymes, proteins, fibers & lipids
2.9 Nutrition, Health Claims and Labeling
2.9a Trans Fatty Acids
2.9b Meet Premarket Review Statutory Timeframes (Infant formula)
2.9c Nutrient Content/Health Claims (120-days)
2.9d Nutrient Content/Health Claims (190-days)
2.9e Infant Formula
2.9f Citizen Petition(98P-0968)
2.9g Food Regulatory Report
"B" List (Nutrition, Health Claims and Labeling)
2.10B Nutrient Content/Health Claim notifications Based on an Authoritative Statement
2.11B Amend Regulations on Nutrient content claims and Health claims to Provide Additional
Flexibility
2.12B Establish a Pilot Enforcement Program directed at Consumer Deception on Food
Labeling
2.13B Initiate Public Forum on Scientific and Regulatory Framework for Structure/Function
Claims
2.14 Dietary Supplements
2.14a Ephedra
2.14b New Dietary Ingredients
2.14c Nutrient Content/Health Claims
2.14d Overall Strategy
2.14e Stakeholder Outreach
2.14f Citizen Petition 98P-0509
"B" List (Dietary Supplements)
2.15B Elevate the Priority of Field Assignments on Dietary Supplements
2.16 Chemical and Other Contaminants
2.16a Patulin
2.16b Pesticide Monitoring Improvements Act (PMIA)
2.16c Total Diet Study Workshop
2.16d Fumonisin
"B" List (Chemical and Other Contaminants)
2.17B Compliance Policy Guide for Filth in Food
2.18B Compliance Policy Guide for Hard Sharp Objects in Food
2.19B Guidance Document - Lead Containing Decoration on Glassware
2.20B Compliance Policy Guide for Sampling and Analyzing Fresh and Frozen Raw Shrimp
2.21B Compliance Policy Guide, Pesticide Residues in Food and the Food Quality Protection
Act of 1996
2.22B Elemental Analysis Manual
2.23 Cosmetics
2.23a Alpha Hydroxy Acids
2.23b Diethanolamine
2.23c Voluntary Reporting
2.23d Program Restoration
3.1 Science Base
3.1a Joint institute for Food Safety and Applied Nutrition (JIFSAN)
3.1b National Center for food Safe6ty and Technology (Moffett Center)
3.1c Review Non-FSI Research/ Consolidated Mgmt. System for FSI and non-FSI Research
3.1d Peer Review
3.1e Scientific Expertise across CFSAN Regulatory Programs
3.2 Federal-State-Local
3.2a Integrated Food Safety System
3.2b Food Code
"B" List (Federal-State-Local)
3.3B Milk Safety
3.4B Shellfish
3.5B Retail
3.6 International
3.6a Develop Affirmative Agenda
3.6b Equivalence Criteria
3.6c Equivalence Determinations
3.7 Human Resources
3.7a Communication
3.7b Training
3.7c Quality Environment
3.7d Future Skill Needs
I. FY1999
II. FY2000
OCAC-Office of Cosmetics and Colors
DSAT-Division of Science and Applied Technology
OPA-Office of Premarket Approval
DMBRE-Division of Molecular Biological Research and Evaluation
MBB-Molecular Biology Branch
OPDFB-Office of Plant and Dairy Foods and Beverages
DFPP-Division of Food Processing and Packaging
DNP-Division of Natural Products
DVA-Division of Virulence Assessment
OS-Office of Seafood
DSAT-Division of Science and Applied Technology
DPEP-Division of Programs and Enforcement Policy
OSRS-Office of Special Research Skills
DMS-Division of Microbiological Studies
DTR-Division of Toxicological Research
OSN-Office of Special Nutritionals
DSAT-Division of Science and Applied Technology
OFL-Office of Food Labeling
DTE-Division of Technical Evaluation
OSAS-Office of Scientific Analysis and Support
DGSS - Division of General Scientific Support
DMS- Divison of Market Studies
Executive Summary | Table of Contents | Research Projects | Appendices