U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
March 29, 2000

Review of CFSAN Research Programs

RESPONSE TO THE AUGUST 25, 1999, CRC REPORT
"REVIEW OF RESEARCH PROGRAMS"

I. Introduction

The Center for Food Safety and Applied Nutrition (Center/CFSAN) would like to thank the CFSAN Review Committee (CRC) and the Science Board (SB) for devoting their time and energies assisting us in strengthening our research and laboratory programs. We wholeheartedly agree with the peer panel's recommendation, "CFSAN must maintain mission-related research programs of world class quality, and of a size commensurate with obligations, to fulfill its mission." The CRC's comments on the overall quality of our research program and scientists are greatly appreciated. It is particularly gratifying to learn that our efforts in areas such as pathogen emergence, microbial risk assessment, methods development, prevention and intervention, and emergency response are so well regarded.

In preparing our response, we have attempted to take a broad approach, that is to say, we have tried not to respond to each of the recommendations individually. Our thinking was that it would be more beneficial to provide information on the steps already taken and those we intend to take to implement the panel's recommendations.

Our response attempts to parallel the format used in the August 25, 1999, "Review of Research Programs, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration." In "Section II. CFSAN: Overall Evaluation," information is presented in response to the three overarching themes: (1) Specific Programmatic Issues, (2) Personnel Management Issues, and (3) Research Management Issues. Since many of these themes are repeated for the individual research areas, in "Section III. CFSAN Evaluation: Individual Research Programs," we have attempted to restrict our response to matters not previously addressed. Intentionally, we have not responded to the recommendations contained in "Section IV. Critique of the Review Procedure," believing that this matter must first be considered by the SB, itself.

II. CFSAN: Overall Evaluation

We appreciate the peer review panel's thoughts on strengthening our research programs in toxicology and applied nutrition. We wish to assure the CRC and the SB that as we move forward in this undertaking, we will pursue a thoughtful and calculated approach that reinvigorates research in these areas while simultaneously assuring that the research is strongly tied and responsive to our regulatory and review functions. Further, this will be accomplished in a manner that does not sacrifice other equally critical research.

The Center appreciates the concern expressed by the CRC that the proper balance between programs has been disrupted by the attention given to the Food Safety Initiative (FSI). The Center has taken several steps to address these concerns including: (1) the establishment of the CFSAN Science Council with the specific goals of fostering communication between scientists within the Center and other FDA Centers, and providing management with advice and guidance on research priorities; (2) the restructuring of CFSAN's Office of Science (OSc) headed by the Senior Science Advisor; (3) hiring a Deputy Director for OSc; and (4) the appointment of a new Director for the FSI.

A. Specific Programmatic Issues

Toxicology

As CFSAN's toxicology research is housed in MOD-1, a task force on MOD-1 utilization and enhancement recently presented their review to the Center Director as a draft report, "Enhanced Utilization of FDA Module-1 to Support CFSAN Regulatory Research Needs." The task force concentrated its efforts on the problems and opportunities associated with the operation of this research facility and offered suggestions for strengthening in-house research. We anticipate that implementation of the report's recommendations will greatly buttress the toxicology research program. The MOD-1 review also recognizes that attracting and retaining individuals with needed skills will go a long way in rebuilding and refocusing the Center's toxicology program. We plan to recruit a Senior Biomedical Research Service caliber individual as one of our first steps.

Additionally, FDA has entered into an interagency agreement (IAG) with the National Toxicology Program (NTP) administered by the National Institute of Environmental Health Sciences. Many of CFSAN's issues pertaining to toxicology and nutrition are relevant to this program. Specifically, under the IAG requested studies will be performed at the National Center for Toxicological Research (NCTR). CFSAN scientists will contribute substantially to the design, execution and interpretation of these studies. Likewise, this will provide additional opportunities to enhance our ability to call upon the toxicological expertise at the NCTR and thus augment our research and regulatory needs.

Applied Nutrition

A 10-year dietary supplement strategic plan has been developed and published to address regulatory issues and to help identify where research needs to be focused. (A copy of the plan is attached.) The merger of two offices (Food Labeling and Special Nutritionals) will bring better focus to the research program for nutrition and its safety issues. A Lead Scientist for Nutrition was recently named to serve as the Center's chief advocate for and facilitator of nutrition policy and related science across the Center. One of the key roles of the new Lead Scientist is the development of a priority listing of FDA's research needs related to applied nutrition and the communication of these needs to both the intramural and extramural research community. The Lead Scientist for Nutrition will pursue this assignment in consultation with top FDA officials, other government agencies, the scientific and research communities, the food industry and the international community. CFSAN has also been identifying key academic organizations that have particularly strong programs in various aspects of applied nutrition. For example, representatives of CFSAN and NCTR have been discussing potential collaborations with the University of Mississippi's National Center for Natural Products Research in the area of botanical dietary supplements.

B. Personnel Management Issues

As one of our first steps in implementing the recommendations on the appointment of postdoctoral students, we are reviewing our regulatory research needs to determine which of them can be met through postdoctoral appointments. Working with the Oak Ridge Institute for Science and Education Research Participation Program, the Center is actively pursuing these appointments and anticipates completion of the selection process by the end of this fiscal year. At present, one student has been employed under the Student Career Experience Program which extends Federal employment status to students while pursuing their degree requirements and at the same time allows them to conduct research relevant to our food safety program needs.

FDA has been granted training authority under the FDA Modernization Act. Once this authority is implemented, CFSAN will endeavor to bring in visiting scientists and academicians for sabbaticals. This approach is seen as a mechanism to invigorate the research program by providing a continuous infusion of new skills, ideas, and techniques.

A preliminary training plan has been prepared to identify and address training needs of regulatory scientists to strengthen and thereby, enhance the Center's total science base. This preliminary plan is intended to apply to the needs of all Center scientists, including those involved with regulatory review programs, laboratory or other components within CFSAN. The report includes activities that are developed by and conducted through the Center's consortia, the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the National Center for Food Safety and Technology (NCFST).

The recruitment of non-permanent research personnel is very much a part of JIFSAN, a cooperative agreement between FDA and the University of Maryland (UMD) to develop and coordinate national and international programs in food safety. Through the JIFSAN mechanism, UMD undergraduate interns, graduate students, and postdoctoral fellows can be funded to work in CFSAN laboratories. In addition to the formal JIFSAN mechanism, Center scientists are encouraged to mentor graduate students from local universities.

As part of CFSAN's professional development program, a review of the current peer review process for research and regulatory scientists will be conducted. One of the areas to be evaluated will be the advisability of moving to a cyclic, mandatory peer review program. In the past, peer reviews have only been conducted when scientists wanted to be considered for promotion. The program will also be reviewed to determine if its current focus represents a hidden barrier to the conduct of research that directly supports the regulatory needs of the agency. It will also be evaluated to determine if its current review criteria hamper the conduct of collaborative research.

C. Research Management Issues

Strategic planning is recognized by CFSAN as an integral part of how to better manage its research and laboratory resources. As mentioned above, this process was used in developing our 10-year plan on dietary supplements. We are also very active in strategic planning across the Federal government under the aegis of the FSI and the President's Council on Strategic Planning. It is our intention to use this strategic plan, the dietary supplement strategy, and our annual priorities document as background from which a more comprehensive Center strategic plan can be developed. We believe this will assist us in responding to the peer panel's suggestions on research planning, emergency management, collaborative efforts, expanding risk assessment activities, and improving technology transfer. (Copies of the draft FSI strategic plan and the 2000 Priorities document are included.)

A CFSAN Research Program Task Force is currently working on the development of a consolidated research program management system that ensures that priority, mission-relevant public health needs are addressed in a cost-effective, accountable and transparent fashion. The group will prepare a report to the Center Director, through the Senior Science Advisor, to include: (1) assessment of current mechanisms for research project planning/development, resource allocation, tracking, reporting, review, and termination; (2) identification of options to achieve the goal; (3) recommending the "best option" among alternatives; and (4) a preliminary implementation plan with time lines.

A center-wide priority listing for FY 2000 was developed for equipment needs. The following criteria were used in the prioritization process: (1) essential for completion of current research, (2) needed replacements because of age or disrepair, (3) new or updated technology or capability, (4) highly expensive priority instrumentation needed for the Center's overall scientific infrastructure, (5) enhancing current capacity for more rapid completion of projects under the FSI 3-year research plan, (6) enhanced ability to attain future goals, (7) availability of alternative funding, and (8) items designated as low priority by project managers.

Accreditation of regulatory laboratories is considered a priority by FDA and CFSAN is committed to obtaining accreditation for its laboratories involved in regulatory analyses. The color certification program is the most prominent regulatory activity where accreditation is necessary since all lots of food and cosmetic grade colors must be approved before use. The process to obtain ISO-25 accreditation of the program has begun. Cost and benefit estimates are being considered with respect to accreditation of other laboratories, especially for those labs where the analyses are not routine or recurring and are, therefore, difficult to predict.

The Joint Institute for Food Safety Research (JIFSR) was established by the Department of Health and Human Services and the Department of Agriculture (USDA) to coordinate planning and priority setting for food safety research among the two departments, other government agencies, and the private sector to foster effective translation of research results into practice. The JIFSR expects to optimize food safety research investments, channel Federal resources to research that are needed to minimize the impact of current and emerging food safety problems, and avoid research redundancies. A national database on food safety research housed under JIFSR will contain information on all Federal food safety research and will attempt to document private sector investments in food safety research. The database will provide one additional mechanism for communicating the range of food safety research and potential applications.

CFSAN is working to encourage the application of new technologies to solve food safety problems, including the effective transfer of the technologies and knowledge it generates as a result of its own research activities. These efforts are focused in research and development and in streamlining reviews in those cases where pre-market approval is required for use of a new technology. CFSAN developed and implemented new procedures to expedite the review of food additives that are intended to decrease the incidence of foodborne illness.

The CRC's suggestion that technology transfer efforts can be enhanced was also incorporated into our planning activities when we developed and issued two guidance documents on the safety of sprouts. The guidance advises sprout producers and seed suppliers of steps they should take to reduce microbial hazards common to sprout production. A companion guide provides producers with the latest information about testing spent irrigation water, an important step to ensure the safety of sprouts. These guidance documents are a direct result of research conducted by a joint task force of researchers from FDA, NCFST, the University of Georgia, and the USDA. We believe that this effort provides an excellent model that the Center can use and expand upon.

III. CFSAN Evaluation: Individual Research Programs

A. Antimicrobial Resistance and Tolerance

We certainly agree with the panel that research on antibiotic resistance of microorganisms should be a cross-Agency effort. In fact, CFSAN scientists serve on the Commissioner's Task Force on Antimicrobial Resistance to coordinate the Agency's efforts. CFSAN has been part of a research effort involving other Center scientists, ORA, FDA's Center for Veterinary Medicine, and USDA's Agricultural Research Service to investigate the multi-drug resistant strains of Salmonella species that have recently emerged. There is also collaborative work going on with academia (UMD, University of Texas, Kansas State University) to leverage our resources in this important area. Research relating to tolerance and preservation technologies has been reviewed for its focus and ability to provide the information needed upon which to make decisions regarding the development of regulatory standards.

B. Methods Development

While we agree that CFSAN's efforts in rapid method development may appear to overlap with that of industry, academia and other governmental agencies, such duplication, when it occurs, applies only to the pathogen itself and not to the food commodity. The complexity of doing food analysis and the concept that various food types may affect the efficiency of testing methods, are factors which preclude development of methods applicable to all foods and to all agencies. Further, FDA has the additional need to develop or modify methods that can be used as official methods that will serve as the basis of regulatory actions.

Again, CFSAN wishes to thank the CRC and the SB for their efforts.

Attachments:

TABLE OF CONTENTS

1. Introduction

2. CFSAN: Overall Evaluation

   1. Quality
   2. Appropriateness
   3. Balance
   4. Personnel
   5. Management
   6. Other Matters
      Appropriateness of Research Activities in Field Laboratories
      Emergency Response Procedures
      Instrumentation
      Laboratory Certification
      Cosmetic Research
      Codex Activities
      Technology Transfer

3. CFSAN Evaluation: Individual Research Programs

   1. Antimicrobial Resistance and Tolerance
      Introduction
      Evaluation and Recommendations

   2. Hazard Assessment
      Introduction
      Evaluation and Recommendations: Chemical Toxicology
      Evaluation and Recommendations: Microbial Risk
      Evaluation and Recommendations: Balance Between, and Common Goals for, the Programs in Chemical Toxicology and Microbial Risk

   3. Methods Development
      Introduction
      Evaluation and Recommendations

   4. Prevention and Intervention Program
      Introduction
      Evaluation and Recommendations

   5. Regulatory Testing, Analysis and Color Certification
      Introduction
      Evaluation and Recommendations: Color Certification Program
      Evaluation and Recommendations: Regulatory Testing

   6. Applied Nutrition, Foods and Food Labeling
      Introduction
      Evaluation and Recommendations

4. Critique of the Review Procedure

Appendix 3

I.  Introduction

The Food and Drug Administration (FDA), a part of the U.S. Department of Health and Human Services, is a scientific regulatory agency with responsibility for the safety of foods, cosmetics, drugs, biologics, medical devices and radiological products. To accomplish its mission, FDA is organized into five centers with an associated nationwide system of field laboratories: The FDA has several advisory committees, one of which is The Science Board. This Board has recommended that the Centers of FDA be reviewed periodically by special committees composed of non-FDA personnel that are chosen for their ability to critically evaluate the efficiency and effectiveness of these Centers. The current committee, working under the auspices of the Science Board, was assigned the task of reviewing the research operations of The Center for Food Safety and Applied Nutrition (CFSAN or Center). This Center has the mission of promoting and protecting the health and related economic interests of consumers by ensuring that the food supply is safe, nutritious, wholesome and properly labeled; and that cosmetics are safe and properly labeled. CFSAN's responsibilities encompass the safety of all food except meat, poultry and processed egg products, which fall under the authority of the U.S. Department of Agriculture, and the labeling of alcoholic beverages and tobacco, which is regulated by the U.S. Department of the Treasury.

Membership of the CFSAN Review Committee (CRC) is listed in Appendix 1.

The CRC was provided with informational materials prepared by CFSAN personnel approximately two weeks before the date of the review. The review began on the evening of April 13 with introductory remarks by Drs. Joseph Levitt, Bernard Schwetz, Alan Rulis and Robert Buchanan of CFSAN, and Owen Fennema, Chair of the Review Committee. During this session, the purpose of the review and the specific charge to the Review Committee were presented (Appendix 2). On April 14 and 15, oral presentations were made by representatives of the six research groups in CFSAN (Regulatory Testing, Analysis and Color Certfication; Methods Development; Antimicrobial Resistance and Tolerance; Prevention and Intervention Program; Hazard Assessment; Applied Nutrition, Foods and Food Labeling), and each presentation was followed by a lengthy period of questions and answers. CFSAN presenters and accompanying panel members (Appendix 3) did an excellent job of describing, with superb visual aids, the work currently being conducted. However, during the course of these presentations, the CRC had some difficulty in obtaining information about perceived problems and possible corrective actions, and, in some instances, about how essential the work being conducted was to fulfillment of the CFSAN mission.

The CRC deliberated in isolation on the evening of April 15 and the morning of April 16.

II.  CFSAN: Overall Evaluation

A.  Quality

In general, the quality of CFSAN research programs was judged quite good. However, the CRC noted considerable differences in quality among some of the six research groups. The weakest programs, because of insufficient numbers of scientists, appeared to be toxicology and applied nutrition, both of which are important components of CFSAN (see recommendation in "Balance" section).

B.  Appropriateness

All of the major research programs reviewed were considered appropriate activities for CFSAN. The CRC believes research activities, of the types and level now being conducted, are barely adequate to support CFSAN's mission. Regulatory decisions by CFSAN must have a strong scientific basis if these decisions are to be respected by the courts, the public, those being regulated, and by countries that the U.S. is dealing with in international trade. It should be noted that many single food corporations have research groups larger than that of CFSAN, thus creating an obvious dilemma for CFSAN in its attempt to monitor and regulate the commercial food sector in a manner that is responsive, effective, and efficient.

RECOMMENDATION: CFSAN must maintain mission-related research programs of world class quality, and of a size commensurate with obligations, to fulfill its mission.

C.  Balance

The President's Food Safety Initiative (FSI), commenced with resources insufficient to carry out the programs mandated has created a funding imbalance for the six CFSAN research programs. The mandated emphasis on microbiological hazards, which is justifiable but inadequately funded, has resulted in the internal transfer of resources and personnel that has disrupted the distribution of available funds with respect to carefully established priorities. It is the CRC's view that programs in toxicology and applied nutrition have suffered unduly during this redistribution of funds. A few years ago, CFSAN was an acknowledged world leader in food toxicology, but this is no longer true. It is important that CFSAN reestablish its position of excellence in this area, because CFSAN cannot obtain all of the needed toxicological expertise from other governmental agencies.

RECOMMENDATION: CFSAN programs in toxicology and applied nutrition should be strengthened.

D. Personnel

A high quality scientific workforce is an essential component of a strong research program, and developing and retaining this kind of workforce is a major challenge for CFSAN. Furthermore, it is important that scientists be, involved in the planning process, especially with respect to experimental approaches, and that they adapt to many changes as new research priorities and goals are formulated to meet the President's FSI. Some scientists are able to engage effectively in planning, and to adapt readily to change, but others are not. Adapting to new circumstances at CFSAN is especially difficult because scientists are often required not only to change their scientific discipline, e.g., chemistry to microbiology , but also to develop skills to write regulations associated with the new discipline. The expectation that scientists perform the dual tasks of research and formulation of regulations is considered by the Center as a sound approach to fulfilling its obligations, and the CRC agrees. However, this approach does complicate the task of redirecting scientists to new fields of endeavor, especially when few support staff are provided (less than one per scientist) and training programs are insufficient.

CFSAN has successfully hired high quality scientists, and in certain areas, e.g., antimicrobial resistance and tolerance, has been able to retain them. Based on the number of peer-reviewed publications in respected journals, research productivity in CFSAN appears to be reasonable. However, the CRC believes that personnel management practices need improvement in several areas. The Center's program for professional development is undesirably weak; procedures used to evaluate employee performance are less than adequate; job descriptions apparently need improvement with respect to clarity and detail; and personnel classification at the GS11-15 levels appears to need evaluation for accuracy. The latter two aspects are expressed with qualification because the CRC was provided with only limited information about these matters. Nonetheless, the point of overriding importance is that management of personnel must be done in accord with best practices otherwise employee morale, effectiveness and retention rates will suffer.

RECOMMENDATIONS:

1. Postdoctoral and student intern programs are needed to expose researchers and management to new views, and to provide the Center with an effective means for evaluating potential new hires.
2. Increasing the number of support personnel per scientist should be a high priority objective of management. The present number of support staff is woefully inadequate and not cost effective. The consequences are inefficient research and decreased employee morale.
3. Procedures for reviewing the performance of research personnel need to be carefully evaluated and redesigned. These reviews should occur on a regularly scheduled basis and should focus on matters of research productivity, quality, impact, relevance to the CFSAN mission, and ability of the researcher to interact effectively with associates. These reviews, if properly conducted, can be a powerful tool for improving employee morale and effectiveness. This matter should be a high priority consideration by CFSAN management.
4. The program for professional development should be greatly improved and expanded. This includes assuring that scientists regularly attend internal and external short courses in their areas of responsibility, attend at least one national or international scientific conference per year, have access to a sabbatical program, and are encouraged to accept adjunct faculty positions at universities. The successful adoption of these initiatives should strengthen CFSAN's research programs, improve employee morale, and improve the Center's ability to develop reasonable, effective regulations, and to respond rapidly and effectively to public health emergencies.
   

E. Management

The CRC recognizes that management practices are in a state of transition, and that improvements are being instituted. The need for improvement is evident to the CRC, especially in the areas of strategic planning, priority setting, implementation and accountability. How priorities are currently established was not explained in detail, thus, the CRC was inadequately informed to provide detailed advice on this matter. However, it is very important that priorities be established annually by a process that involves pertinent input from all scientific personnel. Once established, an effective means should be devised to assess whether these priorities are implemented properly during the following year. The priorities should also be well publicized both in and outside the Center.

It was stated that a top-down system of management was being imposed, however, its implementation was not evident, especially in terms of conformance of various research projects to stated priorities. (note: Following the review, the CRC Chair was informed that the "top-down" system had been initiated for microbiology research in 1998, but had not yet been initiated for programs in chemistry, toxicology and nutrition). These matters are of great importance and improvements are needed. Part of the problem appears to lie with the inexperience and ineffectiveness of some of the middle managers. Suitable training and/or the hiring of new personnel for these positions should be considered.

The CRC recognizes that the current Director of CFSAN has been in office for a relatively short time, and to his credit, has made good progress in important staff appointments and in changing management practices within the Center. The current review occurred before the CFSAN administration had fully formulated its management plan and before much progress had been made in its implementation. Consequently, the CRC's comments regarding administration of the Center's research activities must be considered in the context of the current state of change.

Based on statements made during the course of the review, it is clear that the Center is proud of its ability to respond quickly and effectively to emergency events, and the CRC believes that pride in this program is justified. CFSAN management appears to regard the research program of the Center as a major tool for attracting and retaining talented scientists for times of crisis. Whereas this is a valid use of the research program, care should be exercised to assure that the full range of CFSAN goals receive primary attention when establishing research priorities. In the current climate of increasingly limited resources and crises that occur frequently, this approach to research is imperative.

The CRC believes the Center Director recognizes most of these problems and is taking remedial action. It is important, however, that ensuing changes be based on a comprehensive strategic plan for CFSAN - one with a clear mission statement, clear objectives, conversion from a "bottom up" to "top down" management system (as is already being imposed), and defined measures of success, i.e., accountability. The strategic plan must be accompanied by carefully devised implementation procedures. If a strategic plan had been available, CRC's evaluations, of the appropriateness of various research activities would have been more detailed and reliable.

RECOMMENDATION: The CRC encourages the Center to move with dispatch to develop a strategic plan that provides clarity of mission and goals, and needed measures of accountability. Use of outside expertise to facilitate development and execution of the plan is advised. The plan must be devised so as to assure that: 1) approach, 2) management procedures are clearly stated and provide for accountability, and 3) determination of the appropriateness of various research activities can be easily determined.

This strategic plan will benefit the Center in several ways. Most importantly, it will provide clear guidance for organization, management decisions and operational practices. Publicizing such a plan will also enhance the Center's credibility, particularly if progress in attaining the stated goals is evident. Additionally, this plan will, if developed with participation of the CFSAN staff, serve as the "blueprint" for the culture change the Center must bring about.

RECOMMENDATIONS:

1. All personnel should be fully cognizant of the goals of their program. Each project should undergo a formal review annually and be evaluated for progress, current priority status, and likelihood that continuation will lead to success.
2. CFSAN should strive to move from its current FTE-based budgeting practice to one that is program based. Without such a change, true costs, effectiveness and accountability of research programs cannot be meaningfully assessed.
3. The Science Board and the FDA Chief Scientist should consider the present review as step 1 of a 3-step process. The second step should be a review of progress in developing CFSAN's management/strategic plan and should take place in 6-9 months. Only a few skilled reviewers are needed. Step three should focus on how well CFSAN research activities correspond to provisions of the strategic plan, and should occur in about 12-18 months.

F. Other Matters

Appropriateness of Research Activities in Field Laboratories

Food safety research within FDA is being conducted at both CFSAN and the field laboratories of the Office of Regulatory Affairs (ORA). The CRC has concerns about duplication of effort, significance of impact, and usefulness of research results obtained at field laboratories. Although research activities in field laboratories are controlled by ORA, with CFSAN serving only in an advisory capacity, the CRC believes it is appropriate to express its concerns about these activities because they have an indirect impact on CFSAN's research budget.

FDA field laboratories should not conduct research unless the reasons are compelling, and the following are available: qualified personnel with reasonable commitments of time, appropriate instrumentation, and adequate resources. In the CRC's judgement, few instances of this kind exist. For example, one or two persons spending 10% of their time on research cannot be expected to function in an effective manner. Moreover, basic studies in areas such as methods development and hazard assessment are clearly inappropriate for investigation at field laboratories. Study of local problems or highly specific methodologies may be appropriate.

When research at a field laboratory is considered appropriate, care should be taken to assure that proper quality standards are maintained and that close collaboration occurs between researchers at the field laboratory and those at CFSAN. Collaboration of researchers at field laboratories with faculty members of local universities should also be encouraged to strengthen approved projects. Field laboratory personnel should be consulted when priorities for CFSAN research programs are established, and, similarly, CFSAN personnel should be closely involved in establishing priorities for research projects at field laboratories. (Note: following the review, the Chair of the CRC received information indicating that authorization for methods development in field laboratories involves preparation of a proposal by the field analyst working in cooperation with a CFSAN scientist, and review of the proposal by a panel of CFSAN scientists using quality, relevancy and avoidance of redundancy as criteria. This supplemental information is appreciated, but does not lessen the CRC's concern about this matter).

RECOMMENDATION: Using CRC's concern as justification, CFSAN should encourage FDA management to carefully review research programs at FDA field laboratories and deactivate those programs that are too feeble to be effective, or are inappropriately focused. Cost savings that accrue from a paring of these activities should be used to augment research programs in well-established CFSAN laboratories.

Emergency Response Procedures

Although the CRC did not have an opportunity to evaluate in detail CFSAN's emergency response procedures, the Committee was left with a favorable impression regarding the effectiveness of these procedures. The only concern is that an emergency in one area will disrupt unduly the work of other programs as personnel are assembled in response to the emergency. The CRC believes that proper anticipatory planning would help minimize disruption of ancillary programs during these occasions.

Instrumentation

The CRC did not have an adequate opportunity to thoroughly evaluate the appropriateness of CFSAN instrumentation. However, our impression is that instruments (kinds, quality and amount) are, in general, adequate for fulfilling the CFSAN mission, but that many are not state-of-the-art.

RECOMMENDATION: CFSAN should prioritize its instrument purchases with great care.

Laboratory Certification

It is important that research results by CFSAN be acknowledged world wide as indisputable. Laboratory certification is an important prerequisite for attainment of this status. CFSAN does have a Good Laboratory Practice/Quality Assurance program, and has obtained "Certified" status for laboratories that conduct analyses for regulatory purposes.

RECOMMENDATION: The CRC strongly endorses CFSAN's present policy regarding laboratory certification.

Cosmetic Research

Research on cosmetics is an orphan program within FDA that historically has been located in CFSAN due to the presence of the food color/toxicology program. There appears to be no obvious disadvantage to having this program within CFSAN and some advantage to CFSAN arises from the presence of the associated instruments and personnel. It is important that FDA have competency in this area especially since the use of new bioactive substances (e.g., alpha hydroxy acids) in cosmetics has increased. Care should be taken to assure that activities in this area are well coordinated with similar activities in other groups outside CFSAN.

RECOMMENDATION: Activities in cosmetic research should be closely coordinated with other dermatology/transdermal research programs being conducted within FDA.

Codex Activities

FDA must have major involvement in international programs dealing with food safety so that international regulations and compliance procedures that are developed will help assure, to the maximum degree reasonable, that food crossing international boundaries is safe, and that differences in food safety standards are not used unfairly as a means to impede fair international trade in food. To develop international food regulations that are scientifically sound, research in some areas will be required. Use of CFSAN's research expertise is inevitable, and it is therefore advisable that CFSAN be represented in international groups that deal with these issues.

RECOMMENDATION: Participation of CFSAN personnel in CODEX programs and other similar international programs is essential and should be continued.

Technology Transfer

Prompt and effective technology transfer is an important measure of CFSAN success. However, technology transfer activities are limited within CFSAN, and they relate primarily to assisting small companies and state health agencies in adopting Good Agricultural Practices and Good Manufacturing Practices.

RECOMMENDATION: CFSAN should, if they are not already doing so, develop tools to measure the effectiveness of the technology transfer process, and apply these tools on a routine basis.

III.  CFSAN Evaluation: Individual Research Programs

A.  Antimicrobial Resistance and Tolerance

Introduction

In the materials provided to the CRC, this program is said to focus on determining how pathogenic microorganisms adapt to natural and human-induced barriers to their growth. The purpose is to understand the adaptation mechanisms so that new control measures and regulations can be adopted as needed. Areas of special interest are the mechanisms by which pathogens develop resistance to antibiotics and resistance to control measures that are traditionally used by the food industry, such as alteration of pH or water activity, heating, and the use of chemicals.

Evaluation and Recommendations

The term "Antimicrobial Resistance and Tolerance" does not clearly describe the activities of this group and leads to misconceptions and possibly unfulfilled expectations. The main and most visible activities relate to the emergence of virulent lineages of foodborne pathogens and the underlying molecular genetic mechanisms. Because the title and activities do not match well, some expectations appear to be left unfulfilled, despite the research being of excellent quality. The fault lies more with management and vision than it does with the quality of intrinsic relevance of the research. The development and epidemiology of antimicrobial resistance, including resistance to commercial disinfectants and processing intervention procedures, and the emergence of antibiotic resistant organisms as they relate to food manufacturing and processing practices, are highly relevant to CFSAN's mission, but are not strengths of this program. The topic of emergence of antibiotic resistant organisms is being addressed by the FDA Center for Veterinary Medicine (CVM), and CFSAN's work in this area should be carefully coordinated with that of the CVM.

RECOMMENDATION: Change title to this program to: "Emergence of virulence and antimicrobial resistance among foodborne pathogens." This will more clearly associate activities of this program to the Center's mission, and will provide guidance for future program development.

The research on pathogen emergence is excellent and clearly makes an important contribution to establishing the credibility of research at CFSAN. This is a fine example of the type of world-leading research that CFSAN must produce if it is to maintain its position as a "center of excellence." This expertise was of central importance in national deliberations on the use of antibiotic resistance determinants in agricultural genetic engineering because it enabled CFSAN to serve as a respected neutral consultant and provide valuable advice to companies seeking guidance in this area. Such illustrations of the practical benefits that can arise from basic research, and the relevance of this type of technology transfer to CFSAN's regulatory mission, were not highlighted in the review process. This, and other similar examples, should have been used to demonstrate that relevant research is a critical prerequisite for fulfillment of CFSAN's mission.

RECOMMENDATION: Priorities for work in the area of Antimicrobial Resistance and Tolerance should be clearly established.

Because of the FSI and other initiatives, research on the emergence and physiology of foodborne pathogens, particularly with reference to resistance to processing procedures and various agents, is of increased relevance to CFSAN's mission. The emergence of antibiotic resistant foodborne pathogens and the role of food in their dissemination is an important area that deserves attention. Center scientists are uniquely positioned to explore these matters. It is not clear, however, that all current projects relate well to these topics. For instance, developing detection methods for the polymerase chain reaction in foodborne pathogens, might fit more appropriately under the aegis of the Methods Development group. In addition, it was unclear whether this line of research was essential to the successful accomplishment of the CFSAN mission, was a state-of-the-art orphan project, or was simply of commercial interest. In contrast, studies on the mechanisms of emergence of foodborne pathogens are well conceived and important.

RECOMMENDATION: Research on antibiotic resistance of microorganisms is of major importance and should be carefully integrated in a cross-center effort. This subject is also of central importance to the Center for Veterinary Medicine and other centers.

The CRC is not convinced that all aspects of the work on induction of acid tolerance and DT 104 are unique. Work of this kind is being conducted in universities and other federal agencies and the degree of collaboration is not clear. This work should be carefully coordinated with current research at universities. Results from this research are relevant to new processes being developed by the food industry and should be considered when standards for these processes are developed.

Information provided to the CRC regarding CFSAN research on Listeria epidemiology and Salmonella was insufficient to enable the uniqueness and quality of this work to be judged.

Other areas that are pertinent to the activities of this group are the relationship between biofilm physiology and resistance of microorganisms to disinfection procedures, and food as a vehicle for the transmission of antibiotic resistant organisms.

RECOMMENDATION: The CRC is supportive of most of the research being conducted in this area, and the presence in CFSAN of persons with the skills needed to conduct research. This group has an important role in emergencies involving food pathogens. It is imperative that the research conducted be of the highest quality so that results generated will be accepted as valid by all parties when crisis events arise.

B.  Hazard Assessment

Introduction

The hazard assessment program comprises two areas of focus: chemical toxicology and microbial risk analysis. The stated goal of the programs is to identify the scope of hazardous effects of chemical and microbial toxicants and to define their dose-response relationships under various regimens of exposure.

Evaluation and Recommendations: Chemical Toxicology

The hazard assessment program for chemicals serve primarily as support for other CFSAN programs rather than as a stand-alone research effort. The program appears to have a conventional toxicology screening focus. There are few examples of cutting-edge research in this area, although the dermal assessment program is well respected and unique. While CFSAN has a proud history of toxicology excellence, it has lost its leadership role in this field. The program's efforts are currently misdirected and are not consistent with modern toxicological practices, i.e.; they do not have a risk-based focus. The program does not deal with chemical mixtures or food-related biotechnology issues, and its role in FDA's regulatory mission is unclear. For example, it does not appear to be linked to the nutritional programs of CFSAN, a relationship that would strengthen both programs.

FDA needs a strong chemical toxicology program to support CFSAN's mission and regulatory activities. There is no other regulatory toxicology program that tests cosmetic components and food additives.

RECOMMENDATION: Management should determine which aspects of research in chemical toxicology should be in CFSAN and which aspects can be provided by other governmental groups. Those aspects that support CFSAN's unique regulatory responsibilities should be strengthened in-house as well as through partnerships with other organizations. For example, CFSAN should consider partnering with, and in some cases depending on, state-of-the-art toxicology laboratories, such as FDA's National Center for Toxicological Research.

Evaluation and Recommendations: Microbial Risk

Microbial risk assessment is a small but rapidly developing field. This is a new program for FDA, established primarily in response to the FSI. World-class experts in microbial risk assessment have been hired, and collaborations with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the, Risk Assessment Consortium have been developed. These initiatives provide an opportunity for CFSAN to develop national and international leadership in this area. However, resources are sufficient for only two quantitative risk assessments (e.g., Listeria and Vibrio) annually. For a center whose activities are devoted overwhelmingly to the public health impact of microbial contaminants in food, and which purports to be moving toward a risk-based regulatory framework, the inability to conduct more than two microbial risk assessments annually is a serious shortcoming.

An outstanding program in microbial risk assessment is essential if FDA is to fulfill its regulatory mission in a satisfactory manner. The current program is unique and has the potential to develop an important new area of risk assessment in which FDA must assume a leadership role. This program will, if properly developed, become a signature program of CFSAN and greatly enhance the Center's credibility and effectiveness.

RECOMMENDATION: CFSAN's microbial risk assessment program should be helping to establish improved HACCP protocols. CFSAN's in-house capability in microbial risk assessment should be enhanced with additional personnel and resources to help propel CFSAN toward a leadership role in this field. Partnering with other world experts, in the U.S. and other countries, should be considered to facilitate development of common methodologies and enable broader coverage. In addition to developing methodologies, a greater number of risk assessments should be performed annually to facilitate control of microbiological hazards. Methodologies for determining "acceptable" levels of risk for use in regulating microbial contaminants are also needed. Current partnerships with the Centers for Disease Control and Prevention (CDC) and use of international databases should continue to be emphasized, as should evaluation of risks from microbial contaminants in actual food matrices.

Evaluation and Recommendations: Balance Between, and Common Goals for, the Programs in Chemical Toxicology and Microbial Risk

Because of the FSI, CFSAN research has undergone a pronounced shift away from chemical toxicology to pathogenic microorganisms. The CRC believes this shift has been excessive and the toxicology program has suffered unduly. For example, food allergies and sensitivities are important areas for CFSAN, yet these areas are receiving little attention. To best assure public health protection, a public health-based process for setting priorities in chemical and microbial toxicology is needed. This process should be a top-down approach starting with evaluation of public health problems and then identification of potential causes of the problems as a guide to solving them. Research and regulatory priorities based on a public health approach will help assure that limited resources are used most effectively. While responding to emergencies is an important role that CFSAN does well, a comprehensive priority-setting process based on evaluation of key public health issues would position CFSAN proactively as well as reactively. CFSAN's recent priority-setting exercise and JIFSAN's activities are good steps in this direction.

RECOMMENDATION: To use risk assessment appropriately in regulation, CFSAN should develop a public health-oriented approach to establish regulatory priorities for hazardous chemical and microbial agents. The priorities established should encompass the full food chain from pre-harvest to consumer. Because CFSAN alone does not have the mandate or resources to conduct a comprehensive assessment of public health, it should collaborate with other agencies.

C. Methods Development

Introduction

Analytical methods, properly developed and validated as suitable for the intended purpose, must be used to generate data of the quality needed to support CFSAN's regulatory rulemaking and enforcement actions, as well as for defending its actions in courts of law. Development of analytical methods consumes a major portion of the time of the CFSAN research staff, and the results benefit nearly all offices within the Center.

More specifically, development of methods to detect and quantify microbiological agents, toxicants and essential nutrients is critically important to the regulatory mission of FDA. The emergence of new pathogens and toxins accentuates the importance of this type of research. The more rapidly the procedure can be performed, the more useful it is likely to be for assuring and regulating the safety of the food supply. Approximately one-third of Center's research budget is committed to methods development and the CRC believes this is appropriate.

Evaluation and Recommendations

CFSAN Scientists are among the leaders of the world in developing methods for detecting potentially hazardous agents in foods, and its research is innovative and appropriate. The committee commends researchers in this group for the high quality of their research accomplishments. However, some redirection of this group's priorities may allow limited resources to be used more effectively. For example, some CFSAN projects deal with the development of rapid methods, particularly for the detection of pathogens (e.g. E. coli 0157:H7) in foods. This work appears to overlap with research being conducted by private companies, academia, and other governmental agencies.

An adequate strategic approach to prioritizing work on methods development does not appear to exist within CFSAN and this situation needs to be corrected.

RECOMMENDATIONS:

1. The FDA should develop an agency-wide plan for methods development research. A strategic approach using defined criteria for priority setting should be adopted. This process should involve all relevant governmental centers both within and outside the FDA. All aspects of food safety should be addressed. A strategy should also be developed to prioritize the development of methods for detecting new agents of public health concern. Direct ties to overall program priorities and research plans should be in place.
   
2. CFSAN should carefully monitor the activities of the private sector, other governmental agencies, and academia in developing methods for specific pathogens, toxins and chemicals, and enter into collaborative arrangements when individual microorganism or toxin for which rapid methods are most needed and communicate these priorities to potential developers in the private sector to help avoid duplication of effort.
   

D.  Prevention and Intervention Program

Introduction

CFSAN provides guidance on the acceptability of various techniques used by the food industry for avoidance of foodborne diseases. Strategies for the production of high quality agricultural commodities that are less likely to support pathogen survival and growth are included in the scope of its activities. Outcomes from these activities are science-based policies/regulations that are available for developing and monitoring inspection and Hazard Analysis Critical Control Point (HACCP) programs.

Some examples of projects included in CFSAN's Prevention and Intervention program are: (1) development of procedures to improve the safety of sprouts, apple cider, and seafood, (2) determination of pathogen survival during 60-day aging of hard cheese products made from fresh milk, (3) evaluation of the suitability of new packaging materials for irradiated prepackaged foods, and (4) validation of the microbial safety of new non-thermal processes.

Evaluation and Recommendations

Without the information provided by the kinds of projects cited in the introduction, CFSAN would be unable to properly evaluate the safety of new technologies and to formulate sound, science-based regulations governing how these technologies are employed.

RECOMMENDATION: The CRC endorses CFSAN's research activities to determine safe practices for new or modified food processes, but recommends that management regularly: (a) evaluate these projects for conformance to CFSAN priorities, progress and impact, and (b) determine for each project how the objectives can be achieved most effectively and efficiently, i.e., should the studies be conducted in-house, in collaboration with other groups, or by contract with other parties?
To attain the goals of the Prevention and Intervention program, research collaboration is underway among CFSAN-Washington, DC, CFSAN-Dauphin Island, the National Center for Food Safety Technology (NCFST/Moffeft Center), USDA-Agricultural Research Service, University of Illinois, University of California at Davis, University of Maryland, the State of California, Durango County, California, and the food industry.

These collaborative ventures appear to be working well. For example, the CFSAN/National Center for Food Safety Technology partnership in Illinois is an excellent example of how various groups with interests in food safety regulation can work together effectively.

RECOMMENDATION: The CRC endorses research collaboration among various groups with interests in food safety practices and regulations, provided these collaborations have been determined to be the most effective and efficient approaches available. Factors that should be considered when contemplating collaboration include: availability of appropriate personnel, equipment and facilities; cost effectiveness of various alternative options; and likely long-term effectiveness of the partnership.

Globalization of food production and distribution is occurring rapidly and this raises broad new challenges for CFSAN. An important concern is the safety of food, especially fresh fruits and vegetables, being imported into the U.S.

RECOMMENDATION: CFSAN should be a world leader in establishing standards and procedures (reliable sampling procedures; rapid, accurate, and economical tests) for assuring the safety of foods crossing international boundaries. Safety when leaving the country of origin should be emphasized.

E.  Regulatory Testing, Analysis and Color Certification

Introduction

Regulatory testing/analysis activities focus on the collection and analysis of samples to determine compliance with existing regulations. Collected data are used to initiate enforcement actions and to support the Center's position in potential challenges by the regulated industry.

Research in the color certification area is conducted to provide CFSAN with relevant information for future regulatory actions, to improve test methods and to provide testing guidance to industry. This is a unique, service-oriented program with industry as the client. The program operates on user fees and is self-sustaining.

Evaluation and Recommendations: Color Certification Program

Retaining the color certification program within FDA provides credibility to the
certificates that are issued because of the exacting standards imposed by FDA. Another benefit of this activity is that it provides skilled professionals and instruments that are useful to other programs within CFSAN.

RECOMMENDATION: Relative to the research component of the Color Certification Program, new methodologies and instrumentation should continue to be evaluated and introduced to enhance the quality of service to clients and to maintain state-of-the-art skills within CFSAN.

Evaluation and Recommendations: Regulatory Testing

This activity consists of sampling and sample analyses for problem identification and emergency response. The focus is on potential major outbreaks of foodborne illness, adulteration, and other risks to public health. This activity appears to be outbreak-oriented and does not address the possibility of widely scattered isolated cases, other than through PulseNet. The goal is to limit adverse effects on public health through early identification of unsafe food, and conditions that can lead to unsafe food.

Regulatory testing within CFSAN is a highly visible, mandatory function which must continue to operate efficiently and with the highest standards of excellence if CFSAN's mission is to be successfully accomplished. Fifteen percent of the Center's resources are devoted to this activity. As threats to public health arise, CFSAN must quickly assess the seriousness of the event, and determine the means, magnitude and duration of response. Uncertainties associated with emergencies complicate the process of achieving timely responses that are effective and efficient, and these emergencies are often disruptive to other programs in the Center. The CRC believes that current procedures for emergency response are very good in terms of speed and scientific quality. Attainment of highly credible results requires that emergency response procedures be conducted in accord with the highest standards of laboratory practice.

RECOMMENDATIONS:

1. The Center needs to carefully devise management procedures for emergency events so that these events will not disrupt other activities. Although emergency events cannot be eliminated, management should attempt to develop systems and regulations that lessen their frequency and seriousness.
2. The CRC strongly endorses CFSAN's current policy of operating all laboratories under a Good Laboratory Practices/Quality Assurance program and maintaining Certification for those laboratories conducting analyses for regulatory purposes.

F. Applied Nutrition, Foods, and Food Labeling

Introduction

This program differs from others in CFSAN because of its broad mission and the type of work performed. Rather than basic biomedical research in the conventional sense, the work of this group is applied in nature. It involves conducting surveys and other forms of data collection and data analysis, with a focus on human behavior, disease prevention, and formulation of policies. During the past decade, several Acts of Congress (e.g., the Nutritional Labeling and Education Act, and the Dietary Supplement Health and Education Act) have created a climate of greatly increased demand for research in applied nutrition. This is especially evident in research to support mandated FDA regulatory activities in food labeling, fortification, and dietary supplements. These external demands determine the focus of program activities, thereby precluding development by CFSAN of a long-term research agenda based on evaluation of public health risk. The group's excellent and extensive work on folate fortification, a project that originated because of external mandates, provides a good example of why this group needs to exist within CFSAN and what level of funding is needed to allow it to function effectively.

Evaluation and Recommendations

The applied research on fortification policy and consumer understanding of food labels is unique, strong, and useful. Analytical research on nutritional and natural products is adequate, and the research on infant formulas and medical foods is modest, but also adequate.

Without a strategic plan in place for research in applied nutrition, it is difficult to accurately assess its appropriateness to the CFSAN mission. The research presented appears to be justifiable because it is closely linked to the Center's regulatory responsibilities.

The Committee is concerned that the intense demands for research on crisis issues will interfere with research conducted in anticipation of future needs. This program is on the verge of becoming overwhelmed by concerns and opportunities that arise about various conventional nutrients and dietary supplements. If this occurs, adequate attention to emerging topics such as nutraceuticals and functional foods will not be possible.

RECOMMENDATIONS:

1. A long-term strategic plan for dealing with critical issues related to food and nutrition should be developed. This plan should be based on public health needs as revealed by the National Nutrition Monitoring Program.
   
2. Research should not duplicate unnecessarily that which is being conducted elsewhere, and partners should be sought whenever appropriate and possible. For example, the CRC noted that research on soy products and their effects is currently underway at Iowa State University, University of Illinois, Loma Linda University and other institutions. Thus, work at these institutions should not be duplicated by CFSAN.
   
3. The Committee recommends that this program continue to seek collaborative arrangements with USDA-ARS for expertise in natural products and in food composition.
   

Because little is known about the properties of many herbal and botanical dietary supplements now on the market, and there are 1,500-1,800 such products, the research demands in this area will surely exceed the Center's current capabilities.

RECOMMENDATION: CFSAN should promote a JIFSAN-led Interagency Task Force on "Supplements, Natural Products, Nutraceuticals and Functional Foods" to develop research partnerships with other universities and agencies. Similar strategies could be used to expand applied nutrition research in areas such as food allergens, which will require increasing attention from a regulatory standpoint.

IV.  Critique of the Review Procedure

Although the sentiments expressed in this section are relevant primarily to the FDA Science Board, CFSAN management can also benefit when preparations are made for the next review.

Since formal reviews have not been administered routinely by the Science Board, it is not surprising that this review was administered and conducted in a less than ideal manner. Although the results should be of considerable value to CFSAN management, recommendations of much greater value and reliability could have been forthcoming had the review procedure been better formulated. Reviews of the greatest value begin with a careful process of self-evaluation by the party being reviewed. If results of the self-evaluation--perceived problems, concerns and suggestions for change--are provided to the review committee well in advance of the on-site review, then, the value of discussions during the review are greatly enhanced. In the current review, a procedure of this kind was not requested until too late. As a consequence, the CRC's ability to make insightful recommendations was impaired in some areas and precluded in others. It also would have been of great help to the CRC if, at the outset, CFSAN's mission, specific objectives, successes and failures, and its role in FDA's mission had been described more completely.

By assuming, improperly, that CFSAN management was familiar with the desired review protocol, the CRC Chair must accept some blame for these deficiencies in the review process. The Chair did not discover these problems until about 10 days before the review, at which time rectification was difficult.

RECOMMENDATIONS:

1. The FDA Science Board should prepare guidelines on "How to Prepare for a Review," and these guidelines should be provided to the group designated for review at least six months in advance of the review.
2. Additional reviews of FDA programs should not be conducted until these guidelines are available.
3. In future reviews, CFSAN management should emphasize, in their documents and presentations, types of information that are most likely to enable the review team to accurately identify and analyze all issues of major importance, and to develop recommendations of the greatest value.

___________________________________________________Date____________
Owen R. Fennema, Ph.D.
On behalf of the Review Committee

APPENDIX 1

SCIENCE BOARD SUBCOMMITTEE

Chair

Owen R. Fennema, Ph.D.
Department of Food Science
University of Wisconsin
Madison, Wisconsin 53706

Regulatory Analysis

R. Bruce Tompkin, Ph.D. (Subchair)
Conagra, Inc.
Swift-Eckrich, Inc.
Downers Grove, Illinois 60515

Paul A. Hall, Ph.D.
Kraft Foods, Inc.
Glenview, Illinois 60025

Ian Munro, Ph.D., FRCPath
CanTox, Inc.
Mississauga, Ontario, Canada L5N 2X7

Marion Nestle, Ph.D., M.P.H. (Science Board Member)
Department of Nutrition and Food Studies
New York University
New York, New York 10012-1172

Methods Development

Michael P. Doyle, Ph.D. (Subchair)
Department of Food Science and Technology
Center for Food Safety and Quality Enhancement
University of Georgia, Griffin Station
Griffin, Georgia 30223

Gary E. Martin, Ph.D.
Rapid Structure Characterization Group
Pharmaceutical Development
Pharmacia & Upjohn, Inc.
Kalamazoo, Michigan 49001

Jonathan W. DeVries, Sr., Ph.D.
Medallion Laboratories
General Mills, Inc.
Minneapolis, Minnesota 55427

Antimicrobial Resistance and Tolerance

Steven Ricke, Ph.D. (Subchair)
Poultry Science Department
Texas A&M; University
College Station, Texas 77843-2472

Michael S. Gilmore, Ph.D.
Department of Ophthalmology
College of Medicine
University of Oklahoma
Oklahoma City, Oklahoma 73190

David Acheson, M.D.
Division of Geographic Medicine and Infectious Diseases
New England Medical Center
Tufts University
Boston, Massachusetts 02111

Prevention and Intervention

John Cherry, Ph.D. (Subchair)
Eastern Regional Research Center
Agricultural Research Service, USDA
Wyndmoor, Pennsylvania 19038

Larry Beuchat, Ph.D.
Department of Food Science and Technology
Center for Food Safety and Quality Enhancement
University of Georgia, Griffin Station
Griffin, Georgia 30223

Aubrey F. Mendonca, Ph.D.
Department of Food Science and Human Nutrition
Iowa State University
Ames, Iowa 50011

Hazard Assessment Research

Gail Charnley, Ph.D. (Subchair)
HealthRisk Strategies
Washington, DC 20003

Ewen Todd, Ph.D.
Health Protection Branch, Health Canada
Sir Frederick G. Banting Research Centre
Tunney's Pasture
Ottawa, Ontario, KIA OL2 Canada

John Doull, Ph.D., M.D.
Overland Park, Kansas 66209

Jim E. Riviere, D.V.M., Ph.D.
Center for Cutaneous Toxicology and Residue Pharmacology
College of Veterinary Medicine
North Carolina State University
Raleigh, North Carolina 27606

Applied Nutrition, Foods and Food Labeling

Donald B. McCormick, Ph.D. (Subchair)
Department of Biochemistry
Emory University
Atlanta, Georgia 30322-3050

Gilbert A. Leveille, Ph.D. (Science Board Member)
23 Cambridge Avenue
Denville, New Jersey 07834

Joe Spence, Ph.D.
Beltsville Human Nutrition Research Center
U.S. Department of Agriculture
Beltsville, Maryland 20705

Steve Taylor, Ph.D.
Food Science and Technology
Food Processing Center
Institute of Agriculture and Natural Resources
Lincoln, Nebraska 68583-0919

APPENDIX 2

To improve the operating procedures and management practices of CFSAN so that it can:

• Continually and easily up-date its priorities in -accord with needs,
• Accomplish its mission-related tasks more rapidly, efficiently, and effectively.

• The Review Committee must dedicate itself to careful, fair evaluation of the information presented, and adopt an attitude of constructive criticism
• CFSAN presenters must be willing to fully explore program weaknesses, strengths, and problems, and offer thoughtful suggestions regarding changes that might be helpful.
  

APPENDIX 3

Hypertext updated by cjm/dms 2000-JUL-07