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6 Creating a Research Infrastructure for a Risk-Based Food Safety System T he U.S. Food and Drug Administration’s (FDA’s) food safety research functions are performed predominantly by three intramurally funded centers—the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the National Center for Toxicological Research (NCTR)—with some involvement of the Office of Regulatory Affairs (ORA). The agency’s food safety research mission is also supported by external research centers in formal collaboration with aca- demic institutions as well as a few other activities. The food safety research at these intra- and extramural centers is summarized by topic in Appendix F. The research authority of the FDA’s food programs encompasses two major areas (Musser, 2009): (1) support for the Code of Federal Regulations, with a focus primarily on the development of improved and/or advanced detec- tion methods, and (2) activities in support of specific food safety initiatives, such as the Food Protection Plan, counterterrorism efforts, and appropria- tions conference reports (Musser, 2009). The FDA conducts a large research program in support of its food safety mission. According to the U.S. Department of Health and Human Services’ fiscal year (FY) 2010 justification of estimates (HHS, 2010), total 2009 allocated research funding for the agency as a whole was $190,070,000. This total encompasses research in support of all FDA programs, of which the foods component is only a part. For the FDA’s FY 2009 food pro- grams, the congressional budget included $30,178,0001 (approximately 1 In addition to research, these figures include funding for buildings and equipment and personnel. 

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 ENHANCING FOOD SAFETY 15 percent of the agency’s total research budget) in base research fund- ing for CFSAN and ORA, reflecting an increase of $2,862,000 over the previous FY(Musser, 2009). An additional $1,683,000 was budgeted for food protection research at NCTR for 2009. For FY 2010, center-specific resource allocations for research are summarized in Table 6-1. Overall, the agency’s food safety research initiatives can be categorized as follows: (1) development of rapid detection methods, (2) development of confir- matory methods, (3) biotechnology, (4) virology, (5) in vitro testing, and (6) laboratory enhancement (Musser, 2009). This chapter provides a summary of the research currently conducted under the FDA’s food programs and considers how these research efforts do or do not mesh with the risk-based approach described in Chapter 3. TABLE 6-1 FY 2010 Resource Allocations for Research, by FDA Center Total Research Increase in Funding Center Research FTEs Funding over Last Fiscal Year Center for 30 (premarket $9,478,000 +$374,000 (premarket applied research)a applied research)b Food Safety (premarket applied research)a and Applied 140 (postmarket +$8,006,000 applied research)a Nutrition $54,222,000 (postmarket applied research)b (postmarket applied research)a Center for 16 (premarket $3,043,000 +$789,000 (premarket applied research)a applied research)b Veterinary (premarket applied research)a Medicine 44 (postmarket +$1,208,000 applied research)a $8,195,000 (postmarket applied research)b (postmarket applied research)a $58,745,000c +$6,234,000c National 211 Center for $1,625,000 +$1,625,000 specifically Toxicological specifically for for Protecting America’s Food Supplyc Research Protecting America’s Food Supplyc $1,100,000d No increasee Office of Not available Regulatory Affairs NOTE: FDA = U.S. Food and Drug Administration; FTE = full-time equivalent; FY = fiscal year. a FDA, 2010b. b FDA, 2010b,c. c FDA, 2010d. d This number applies to food research activities only (FDA, 2010e). e FDA, 2009.

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 CREATING A RESEARCH INFRASTRUCTURE Much of the information on which the discussion is based was gathered from a report provided by CFSAN, which was written in response to an FDA Science Board task to review the center’s research and related support programs.2 A review of the research and related support programs at CVM was completed by the FDA Science Board in 2009 (FDA Science Board, 2009) and was also consulted in the preparation of this chapter, as was a packet of materials from the FDA with salient information about NCTR (NCTR, 2009a,b,c). In addition, information was obtained from the FDA website and consultation with FDA staff. INTRAMURAL RESEARCH PORTFOLIO CFSAN3 The FDA’s largest food safety research portfolio is housed in CFSAN. In the above-referenced report provided to the Science Board, CFSAN describes the purpose of its research program as to “conduct applied and translational research that facilitates our enforcement of the Federal Food, Drug and Cosmetic Act, the U.S. Public Health Service Act, the Infant Formula Act, and the Dietary Supplement Health and Education Act.” The report further states that “CFSAN takes advantage of the research capabilities of other federal research agencies, which allows it to focus its research infrastructure on the conduct of critical problem-solving research.” These statements make clear that the center’s research mission is applied in nature. As of this writing, CFSAN had 170 research full-time equivalents (FTEs). For the purposes of this report, these FTEs are classified as primary researchers, engaged in the collection of original data. Information about the proportion of FTEs dedicated to food safety as opposed to nutrition was not available, but the vast majority of the research focus is food safety, with an emphasis on chemical and microbiological public health hazards and, more recently, food defense. Individuals are rarely dedicated solely to research. CFSAN research scientists, research managers, and directors also perform regulatory functions such as reviews (petitions, compliance, guidance, and policy), risk assessments, outbreak investigations, and train- ing. This diversity is considered advantageous to the agency as research scientists become “authoritative sources of information in areas of regula- tory review and policy implementation.” Most of the scientists and staff supporting the center’s research mission are located at the headquarters building in College Park, Maryland. However, 2Personal communication, Chad Nelson, FDA, October 13, 2009. 3 Thediscussion in this section is based on the personal communication with Chad Nelson, FDA, October 13, 2009.

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 ENHANCING FOOD SAFETY the center also operates research facilities in Laurel, Maryland; Summit-Argo, Illinois; and Dauphin Island, Alabama. About 25 agency employees are housed at the National Center for Food Safety and Technology (NCFST) near Chicago, Illinois. NCFST and the other four extramural research centers are discussed in the next section. As with research FTEs, the committee was unable to obtain informa- tion on funding allocated for CFSAN’s food safety mission alone. As noted, however, most of the research at CFSAN has been devoted to food safety. The intramural program at CFSAN is composed of research in the disciplines of chemistry, microbiology, molecular biology, food science, toxicology, immunology, epidemiology, social sciences, education, and risk assessment. Major research thrusts include the following: (1) develop- ment and evaluation of methods to recover, detect, and identify pathogens, chemicals, and biomolecules in foods, including evaluation of emerging technologies; (2) risk assessment; and (3) economics and consumer studies (Musser, 2009). CFSAN currently has about 96 active research projects related to food protection (Musser, 2009). Virtually all of these projects are considered applied in nature; in other words, they are “investigations aimed at developing and applying standards to public health needs” (Musser, 2009). Other important components of CFSAN’s research program include nonlaboratory research on risk communication, labeling, education, and the economic impact of its regulations and enforcement programs. Each intramural research project is, at most, 3 years in duration and may be adjusted as needed during this period. CFSAN did not provide the com- mittee with a full listing of its intramural research projects; however, a list was available online4 (CFSAN/FDA, 2008), and a listing on the state of the science at CFSAN was also made available to the committee. Referencing the two relevant areas (food safety and food defense), the committee was able to produce the table in Appendix F. Some common themes emerge from this table. Consistent with Musser’s presentation (Musser, 2009), a large propor- tion of the research focuses on the development of detection methods. Other important themes include (1) a greater emphasis on pathogens as compared with chemicals/allergens; (2) relatively few projects focused on risk assess- ment and economics/consumer studies, despite these being mentioned to the committee as priority areas (Musser, 2009); and (3) a relative absence of research on control or intervention strategies. 4 See http://www.fda.gov/Food/ScienceResearch/SelectedScientificPublicationsPresentations/ ucm117721.htm#fs (accessed October 8, 2010).

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 CREATING A RESEARCH INFRASTRUCTURE NCTR NCTR is located in Jefferson, Arkansas. The committee received very little information about NCTR’s food safety functions. Therefore, much of the discussion here is based on the center’s webpage.5 The center as a whole receives approximately 28 percent of the FDA’s total research budget, the second largest proportion of that budget (HHS, 2010). About 35−40 of the center’s approximately 200 research FTEs are dedicated to food safety (NCTR, 2009a; FDA, 2010a). NCTR states that its vision is to provide “innovative and vital scientific technology, training, and technical exper- tise to improve public health,” with a corresponding mission statement of “conduct[ing] peer-reviewed scientific research in support of the FDA mis- sion” (NCTR, 2009a, p. 1) (see Box 6-1). In support of the center’s mission, NCTR has identified seven Centers of Excellence (see Box 6-2). As reflected in its name, NCTR’s work is dedicated largely to toxico- logical research. A review of the program reveals that fundamental research appears to be the driving force. For example, the center houses a wide variety of state-of-the-art equipment and is addressing most of the “omics,” all considered emerging transdisciplinary approaches to biological research. Clearly, this center’s mission is much broader than food safety, and many of its initiatives are designed to support the FDA’s drug and devices functions (FDA, 2010a). The committee was not provided information with which to determine the proportion of NCTR’s research budget dedicated to food safety. None- theless, one of the center’s strategic goals is to “conduct research and develop strategic technologies to protect the food supply.” To that end, investigators at NCTR are conducting research in the following areas: (1) food safety, food biosecurity, and methods development; (2) antimicrobial resistance; and (3) gastrointestinal microbiology and host interactions. A list of projects in support of these research initiatives is provided in Appendix F. The committee reviewed information received from the FDA about NCTR, including the NCTR Strategic Plan 00–0, FY00 Accepted Publications, NCTR Food Publications 00–00, and a breakdown of food safety spending and food safety research FTEs for 2000–2007 (NCTR, 2009a,b,c). These materials, especially the Strategic Plan, are clear in delin- eating the center’s vision and mission and its strategic goals for accom- plishing this mission (Box 6-1) (NCTR, 2009a). Of the five strategic goals, Goal 3 pertains directly to food safety, while Goals 4 and 5 involve broad support for the FDA’s mission, which clearly includes food safety. Goal 1, while not related to food safety, does concern nutrition, which is in the domain of CFSAN. The two lists of publications (NCTR 2009b,c) show 5 See http://www.fda.gov/AboutFDA/CentersOffices/nctr/default.htm(accessed October 8, 2010).

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 ENHANCING FOOD SAFETY BOX 6-1 Vision, Mission, and Strategic Goals from the National Center for Toxicological Research (NCTR) Strategic Plan 2009−2013 Vision NCTR is an internationally recognized U.S. Food and Drug Admin- istration (FDA) research center that provides innovative and vital scien- tific technology, training, and technical expertise to improve public health. NCTR—in partnership with researchers from government, academia, and industry—develops, refines, and applies current and emerging technolo- gies to improve safety evaluations of FDA-regulated products. NCTR fos- ters national and international collaborations to improve and protect public health and enhance the quality of life for the American people. Mission NCTR conducts peer-reviewed scientific research in support of the FDA mission and provides expert technical advice and training that enables FDA to make sound science-based regulatory decisions and improve the health of the American people. The research at NCTR supports FDA’s goals: (1) to understand critical biological events in the expression of toxicity, (2) to develop and characterize methods, and incorporate new technologies to improve the assessment of human exposure, susceptibility, and risk, and (3) to increase the understanding of the interaction between genetics, metabolism, and nutrition. NCTR is dedicated to supporting the FDA mission to protect and promote public health by: • roviding innovative and interdisciplinary research that promotes p personal and public health • eveloping novel translational research approaches to provide d FDA/Department of Health and Human Services (HHS) with sound scientific infrastructure and multidisciplinary scientific expertise targeted towards addressing critical Agency, Department, and public-health needs such as personalized nutrition and medicine, that the majority of the center’s work is in toxicology, but it also performs significant work in food safety. It should be noted that many of NCTR’s food safety publications are on non-FDA-regulated items, such as processed eggs and poultry (e.g., Kiess et al., 2007; Khan et al., 2009).

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 CREATING A RESEARCH INFRASTRUCTURE bioimaging, systems biology, bioinformatics, nanotechnology, food protection technologies, and biomarker development • ngaging with scientists across FDA and other government agen- e cies, industry, and academia in cooperative learning to strengthen the scientific foundations vital to developing sound regulatory policy and leveraging resources in order to promote the international standardization and global harmonization of regulatory science • articipating in or leading national and international consortia for p the development of harmonized standards for technologies and methods in risk assessment and for personal and public health Strategic Goals To accomplish its mission, NCTR has established five strategic goals: Goal 1: A dvance scientific approaches and tools to promote per- sonalized nutrition and medicine for the public Goal 2: D evelop science-based best-practice standards, guidance, and tools to incorporate toxicological advancements that improve the regulatory process Goal 3: C onduct research and develop strategic technologies to protect the food supply Goal 4: C onduct bioinformatics research and development in sup- port of FDA’s regulatory mission Goal 5: S trengthen and improve scientific and human capital man- agement and expand training and outreach to retain and train scientific experts critical to address FDA’s scientific needs SOURCE: NCTR, 2009a. CVM The mission of CVM is to protect and promote the health of animals and, in so doing, to protect the safety of meat, milk, and other animal- derived products destined for the human food supply. Research in support of CVM’s mission is carried out through the Office of Research (OR) in Laurel, Maryland. The OR campus houses approximately 70 research

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 ENHANCING FOOD SAFETY BOX 6-2 National Center for Toxicological Research’s (NCTR’s) Seven Centers of Excellence 1. Functional Genomics—uses high-information content microarrays in the development of mechanistic and biomarker data. 2. Hepatotoxicology—addresses critical liver injury issues by applying a systems-toxicology approach. 3. Innovative Technologies—uses multi-faceted approaches to address issues such as counterterrorism, rapid detection of bacteria in food, and sensors and nanotube technology. 4. Metabolomics—aids in the assessment of preclinical and clinical safety issues as part of a U.S. Food and Drug Administration (FDA)- wide biomarkers-development effort. 5. Phototoxicology—assesses the toxic and/or carcinogenic potential of chemicals and agents when exposed to light, or when applied to photo-treated skin. 6. Pr­oteomics—develops and evaluates novel proteomic technologies to facilitate the translation of basic science to medical products. 7. Toxicoinfor­matics—conducts research in bioinformatics and chemoin- formatics and develops and coordinates informatics capabilities within NCTR, across FDA Centers, and in the larger toxicology community. SOURCE: http://www.fda.gov/AboutFDA/CentersOffices/nctr/default.htm (accessed October 8, 2010). scientists and support staff and is organized into 3 major sections: (1) the Division of Residue Chemistry, (2) the Division of Animal Research, and (3) the Division of Animal and Food Microbiology (FDA Science Board, 2009). The FY 2009 CVM research budget was $9.241 million, which sup- ported 57 research FTEs and constituted 5 percent of the agency’s annual research budget (FDA Science Board, 2009). The FDA Science Board report on CVM activities states that roughly 40 percent of CVM activities are focused on food safety issues pertaining to animal feeds, pet foods, aqua- culture, and antimicrobial resistance of foodborne pathogens, although research scientists are frequently diverted from this focus to address emer- gency issues (FDA Science Board, 2009). As is the case for CFSAN, CVM’s food safety research portfolio is diverse. Its Three­Year Research Plan: FY00−FY0 (CVM/FDA, 2008) states that the center’s food safety research program focuses on microbial hazards associated with the preharvest phases of the animal production environment, including animal feeds, with specific focuses on

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 CREATING A RESEARCH INFRASTRUCTURE • analysis of animal feeds for the presence of human foodborne bac- terial pathogens; • identification of factors associated with the presence and persis- tence of zoonotic bacterial pathogens in the animal production ecosystem; • surveys of various food products for the presence of zoonotic food- borne bacterial pathogens; • application of genetic typing methods to track the spread of specific zoonotic foodborne bacterial pathogens; and • identification and comparison of antimicrobial resistance genes in foodborne pathogens isolated from different sources in an effort to characterize the spread of resistant bacteria via the food chain (CVM/FDA, 2008). In addition, CVM supports the FDA’s food safety mission by (1) devel- oping and validating tests for drugs and drug residues, including newly pro- hibited drugs, and (2) conducting surveys of drug residues and pathogens in feeds and in animal-derived foods destined for human consumption. Based on the project descriptions given in the CVM Three­Year Research Plan (CVM/FDA, 2008), the committee itemized specific CVM projects designed to support the FDA’s food safety mission (see Appendix F). As is the case for CFSAN, many CVM projects support the applied research function of developing diagnostic methods for microbes and drug residues; a few studies address more fundamental issues, such as under- standing the mechanisms by which antimicrobial resistance develops. Relatively little effort has been devoted to identifying emerging threats in the area of animal feeds and associated links to human health. While addressing analytical issues is important, some limited CVM efforts sup- port risk-based food safety management. It could be argued that CVM’s survey and microbial source tracking efforts do support the risk mis- sion, but these efforts are minimal in comparison with its other research functions. ORA As explained in Chapter 2, ORA’s role is to support the FDA product centers by inspecting regulated products and manufacturers, conducting sample analysis, and reviewing imported products. ORA also works with state and local (including tribal and territorial) governments, through grants and cooperative agreements, to inspect FDA-regulated food prod- ucts. The resource allocation or priority for ORA research functions was not described to the committee. Although ORA’s total budget for food activities conducted in laboratories is more than $90,000,000, its research budget is only $1,100,000 (with only 6 FTEs), representing just 1 percent

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0 ENHANCING FOOD SAFETY of the FDA’s total research budget.6 ORA maintains science advisors who are special government employees serving as consultants to the specific ORA laboratories to which they are assigned. Additionally, ORA has four staff members in risk management. (The information presented here was obtained from the FDA’s written statements and the ORA webpage.7) With a limited research budget, ORA plays only a minor role in the FDA’s food safety research. Its research functions are conducted at the 13 ORA laboratories, 10 of which conduct food-related work. These 10 labo- ratories focus primarily on developing and validating analytical methods to meet the immediate needs of the field laboratories, work that is highly applied in nature. There are two major ORA research initiatives: the Methods Development and Validation Program (MDVP) and the Analyti- cal Tools Initiative (Glavin, 2008; Musser, 2009). FDA field laboratory personnel are involved in work on method development and validation through the MDVP, although that program is not identified by the agency as “research.” Nevertheless, the program is intended to support regulatory testing (both screening and confirmatory) by (1) identifying needs and priorities in method development to address emerging regulatory issues and (2) improving/updating current regulatory methods. The work includes method assessment and validation aimed at rapidly moving promising methodologies into ORA field laboratories for regulatory use. ORA’s Division of Field Science monitors and coordinates all MDVP activities. Current initiatives include the development of rapid detection methods for foodborne pathogens such as Salmonella, Escherichia coli O157:H7, Shigella, Listeria monocytogenes, and hepatitis A virus, as well as detection of other adulterants using chemical, radiological, and other analytical methods. To illustrate the immediacy of the MDVP work, this program was responsible for the development of a real-time polymerase chain reaction (PCR) assay for high-throughput screening of E. coli O157: H7 during the 2006 spinach-related outbreak. ORA mobile laboratory deployments to Salinas, California, and Nogales, Arizona, to perform rapid screening of Salmonella and E. coli O157:H7 in fresh produce provide additional examples of this program’s reach. The Analytical Tools Initiative is a program for the assessment and vali- dation of field and laboratory analytical tools addressing such critical issues as speed of analysis, increased sample throughput, improved sampling strat- egies, and development of field-deployable instrumentation (Musser, 2009). The ways in which the MDVP and the Analytical Tools Initiative differ was not described to the committee. 6 Personal communication, Chad Nelson, FDA, October 13, 2009. 7 See http://www.fda.gov/AboutFDA/CentersOffices/ORA/default.htm (accessed October 8, 2010).

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 CREATING A RESEARCH INFRASTRUCTURE ExTRAMURAL RESEARCH CENTERS The FDA has five extramural research centers devoted to specific food safety initiatives. Each of these centers is funded at the level of $1–$2.5 mil- lion per year. The centers differ by structure and function; each is described briefly below. National Center for Food Safety and Technology (NCFST) Supported by a memorandum of understanding between the FDA and the Illinois Institute of Technology (IIT), NCFST is the oldest extramural center.8 It was established in 1988 and remains a partnership among IIT, CFSAN, and the food industry. NCFST also houses the FDA Division of Food Processing Science and Technology, which was established by the FDA to form a link with industry to tap its expertise in food technology. NCFST is the only center in which the FDA can work collaboratively with industry and academia on projects related to food safety and technology. A fee-based membership in NCFST allows companies to gain early insight into emerging food safety issues from the CFSAN perspective and to assess the safety of new technologies that may be important for innovation. Such early collaboration with the FDA may also facilitate regulatory approval of new food processes, thereby reducing the time required for emerging processes to reach commercialization. Funding for NCFST for FY 2009 was $2.1 million (Musser, 2009). The research performed at NCFST is organized into four primary scien- tific platforms,9 three of which are particularly applicable to food safety: (1) The Processing and Packaging Platform focuses on investigation of the effects of processing and packaging on food safety, quality, and nutrition. Included are projects focused on validation of traditional and emerging food processing and packaging technologies and the use of food safety objectives to facilitate regulatory approval and equivalency of novel processes. (2) The Microbiology Platform is aimed at generating knowledge of the behavior of microorganisms in food and processing environments to improve food safety and quality and public health. Included are projects on Clostridium botulinum and other spore formers, the use of new molecular methods for studying microbial resis- tance, sample preparation and detection techniques, and detection 8 See http://www.iit.edu/ncfst/ (accessed October 8, 2010). 9 See http://www.iit.edu/ncfst/world_class_food_science/(accessed October 8, 2010).

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 ENHANCING FOOD SAFETY Housed in WIFSS is WCFS, which was established in 2008 as a coop- erative agreement among the FDA; WIFSS; the University of California, Davis, School of Veterinary Medicine; the College of Agricultural and Environmental Sciences; and the greater academic community. The cen- ter’s efforts focus on understanding the risks associated with the interface between production practices and food safety in fresh-produce systems. Administrative oversight of the center is provided in part by WIFSS and the FDA/CFSAN. Annual funding (for a total of 5 years) is in the range of $1.0 to $2.5 million, and some of these funds have been made available to the scientific community at large by way of a targeted extramural funding program in produce safety.14 Extramural Funding Although the FDA pointed out that it is not an extramural funding agency, in actuality it does fund a small number of competitive research grants as well as cooperative research and development agreements, which are almost always focused on a specific stated need of the agency. There are currently 2 projects related to food defense, 31 related to food safety, and 15 related to improving nutrition,15 funded through contracts, cooperative agreements, interagency agreements, and grants. Some of these are awarded to the extramural research centers (e.g., NCFST, JIFSAN), while others are awarded to universities, professional associations, or private consulting firms. Examples of the latter include contracts with RTI International (to support risk analysis efforts), the Association of Analytical Communities (to support methods validation), and the Institute of Food Technologists (to support the FDA’s policies through evaluation of specific topics related to food safety and processing and human health). These extramurally funded projects currently focus on support of agency risk analysis efforts, development and implementation of novel detection methods, and control of pathogens in leafy greens and seafood products. The means by which the FDA determines which research questions should be addressed and funded through its small extramural program is unclear. CFSAN has developed an automated, web-based tracking system for its intramural and extramural research programs called the CFSAN Auto- mated Research Tracking System. The system, designed to improve the efficiency and timeliness of the documentation of research projects, provides a means for information sharing and provides for accountability of the 14 See http://wifss.ucdavis.edu/headcontent/newsletter/2008November_newsletter.php. 15 Personal communication, Chad Nelson, FDA, October 13, 2009 (accessed October 8, 2010).

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 CREATING A RESEARCH INFRASTRUCTURE center’s research efforts. The database is open to all CFSAN employees but not the general public.16 INTERAGENCY COLLABORATION In addition to its intramural and extramural research programs, CFSAN maintains collaborative agreements and interactions with other federal gov- ernment research organizations to facilitate the sharing of information and resources in support of its regulatory mission and its obligations regarding international trade agreements. For example, CFSAN participates in the Interagency Risk Assessment Consortium (IRAC), which comprises 19 fed- eral agencies or offices. The mission of IRAC is to enhance communication and coordination and to promote scientific research on risk assessment. Currently, CFSAN maintains approximately 50 collaborative partnerships with other federal research organizations, including the U.S. Department of Commerce’s National Marine Fisheries Service; the U.S. Centers for Disease Control and Prevention; and USDA’s Food Safety and Inspection Service (FSIS), Agricultural Marketing Service, and Agricultural Research Service.17 In its report to the Science Board, CFSAN describes the reasons for the existence of its research program separate from those of other entities with large research capabilities, such as the National Institutes of Health (NIH). In the case of NIH, the reason given is differences in the mission and scope of the research of the two organizations. Nevertheless, CFSAN and NIH collaborate on a handful of projects, such as in the area of dietary supple- ments and long-term exposure to bisphenol A. WEAKNESSES IN THE FDA RESEARCH PROGRAM The FDA food safety research portfolio is diverse and vast. Some of the research efforts are quite relevant to the agency’s mission, while the rel- evance of others is less clear. There is no central oversight of FDA research, and currently each of the four FDA divisions (CFSAN, CVM, NCTR, and ORA) performing the bulk of the agency’s food research manages its own research portfolio.18 Although the purposes and goals of these individual research programs differ, overlap in some of the efforts is likely. The com- mittee found no evidence of coordination to prevent duplication of effort or to leverage the efforts of one investigator with those of others having complementary skills and interests. 16 Personal communication, Chad Nelson, FDA, October 13, 2009. 17 Personal communication, Chad Nelson, FDA, October 13, 2009. 18 Personal communication, Donald Zink, Senior Science Advisor, FDA/CFSAN, Septem- ber 25, 2009.

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 ENHANCING FOOD SAFETY The committee found that, in some cases, the role of the extramural research centers is poorly defined. Of these centers, NCFST has the most well-defined mission and, with its unique expertise and advanced equip- ment, is well positioned to continue to serve the agency into the future. It offers an invaluable service (evaluation of the efficacy of emerging process- ing methods with respect to foodborne pathogens), although its research portfolio appears to be somewhat haphazard. The mission of JIFSAN is admirable, and despite recent funding reductions, it continues to offer value in providing risk analysis training and serving as a data clearinghouse. However, JIFSAN’s work represents a very small proportion of the risk analysis support the FDA will need to move toward a comprehensive risk- based food safety management strategy. WIFSS/WCFS is new, so predicting its performance or value is difficult; however, WCFS is addressing a high- profile food safety problem in what appears to be an aggressive manner. The remaining two extramural centers, APFSL and NCNPR, have produced little in the way of tangible results by which they can be evaluated. Strategic planning for the FDA’s food safety research needs has been limited in scope and in some instances nonexistent. The FDA Science Board reviews each center every 5 years;19 a review was recently com- pleted for CVM (FDA Science Board, 2009), and the review of CFSAN is currently under way.20 CVM produced an extensive strategic plan for this review, a document that was made available to the committee (FDA Sci- ence Board, 2009). CFSAN did the same—its first strategic planning effort in more than a decade. NCTR also has a strategic plan (NCTR, 2009a). The status of strategic planning for ORA and the extramural research centers is unknown. Apparently the strategic planning process includes both “formal” and “informal” scientific planning, both within the agency and with other agencies having a food safety mission, but the means by which this is accomplished is unclear. In any case, it is apparent that no coordinated strategic planning initiative exists in which all FDA food safety research programs are addressed in a unified way. In the absence of a coordinated agencywide strategic planning effort for food safety research, key questions have not been addressed, including the following: • What is the tangible value of the FDA’s food safety research pro- gram with respect to supporting the agency’s mission? • What is the appropriate balance between basic and applied research? Should the agency even be conducting basic research? 19 Personal communication, Donald Zink, Senior Science Advisor, FDA/CFSAN, Septem- ber 25, 2009. 20 Personal communication, Chad Nelson, FDA, October 13, 2009.

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 CREATING A RESEARCH INFRASTRUCTURE • What are the agency’s research needs, and do they address critical data gaps? • Is the current organizational structure for management of the FDA’s research functions appropriate? If not, what structure would be more so? • How is research prioritized, and how are research resources allocated? • Is the current approach to managing researchers effective? For example, does it make sense to divert researchers to other func- tions when a crisis arises? Or would it be better to have some individuals devoted solely to research and some devoted to other agency functions? The committee believes that, until these basic questions are answered, a unified vision for the FDA’s food safety research will not be achievable. The lack of such a vision results in a poorly coordinated research mission that does not support the development and implementation of a risk-based food safety management system. USING RESEARCH TO SUPPORT A RISK-BASED FOOD SAFETY MANAGEMENT APPROACH The committee recommends a risk-based approach to managing the agency’s food safety research portfolio, as it does for virtually all FDA functions. Not only would this approach fulfill the mission of character- izing and acting on risks from food contaminants, but it would also target research to answering the most pressing (highest-risk) food safety questions and problems. Thus, management of the agency’s research portfolio would benefit from application of the principles outlined in Chapter 3 and from implementation of the recommendations regarding information infrastruc- ture in Chapter 5. From a strategic planning standpoint (Step 1 in a risk-based food safety management system; see Chapter 3), it is important to address the role of the research mission as a whole, which entails identifying agencywide public health objectives and determining how research can contribute to achieving these objectives, as well as what proportion of total resources should go to research relative to other agency functions. Central to these deliberations should be a consideration of the importance of research in supporting risk-based food safety management and what specific role(s) research should play. It could be argued that the development of analytical capabilities (e.g., data analysis, risk and decision modeling) is a research function, and over the next 5 years, extensive resources will be required to develop these tools. Once such tools have been developed, public health risk

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 ENHANCING FOOD SAFETY ranking (Step 2 of the risk-based approach in Chapter 3), which identifies and prioritizes the most pressing risk management issues, can be used to support the allocation of research resources. Although unlikely, it may be that the management of high-priority risks is best approached without the need for additional research, in which case the FDA’s research portfolio could be substantially reduced. It is more likely, however, that research will be needed to address some high-priority issues that the FDA now does not study, and efforts carried out under Step 2 will direct resources to the areas of greatest need and relevance. Research can also be used as a tool in support of targeted information gathering and analysis of interventions (Steps 3 and 4 of the risk-based approach, respectively). For example, information necessary to fill data gaps in risk-ranking or risk-assessment efforts is frequently collected as a research activity. Research can also be conducted to evaluate the efficacy of potential interventions or to aid in determining the feasibility of their implementation. Research can even be applied in monitoring and review (Step 6 of the risk-based approach) as the FDA seeks to evaluate the effi- cacy of interventions after their implementation. Finally, the identification and design of new and innovative ways to apply risk analysis methods to food safety management is a research function that underpins the entire risk-based structure. On a more focused level, research can be used to address unanswered questions for any specific risk. An example is the almost decade-long prob- lem of Salmonella in tomatoes. This would likely be a relatively high- priority issue in a public health risk-ranking exercise. However, there are key research questions, such as the reservoir(s) for the organism, con- tamination routes, and the persistence of Salmonella in the contaminated fruit, that will take substantial resources to tackle. Yet a decision to devote research resources to the problem of Salmonella contamination in tomatoes as opposed to another problem (e.g., hepatitis A in green onions) is inher- ently risk based. To take the argument a step further, if research is directed to the Salmonella/tomato problem, will the FDA get the most value for its investment if it focuses on identifying the reservoir(s) for the organism or on evaluating potential interventions during the postharvest phase? And how does the FDA identify the various ongoing research projects in the academic community that address its priority research areas? If answering such questions is supported by a risk-based approach, the decisions made become more transparent and justifiable even as the use of limited agency resources is optimized.

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 CREATING A RESEARCH INFRASTRUCTURE MOVING FORWARD The first step in applying a risk-based approach within the context of the FDA’s current food safety research portfolio should be to undertake a comprehensive inventory and review of the agency’s existing research program without respect for interinstitutional boundaries (e.g., CFSAN, CVM, NCFST, ORA). Thereafter, each research area should undergo a comprehensive peer review, conducted by FDA and non-FDA scientists, whose purpose should be to evaluate such issues as relevance, funding, productivity, and programmatic benefits in direct support of the agency’s mission. This review might be performed with tools similar to those used in cost–benefit analysis of interventions (Chapter 3) and would provide much-needed information before the strategic planning phase was initiated. Research would then become part of the set of risk management tools avail- able for agency use. Although the documents provided to the committee included a list of priority areas of food safety research, the process used to arrive at this list was not clear. The committee believes that reorganization of the FDA’s research func- tion is warranted and that such reorganization should be risk based. This reorganization may necessitate a creative approach to the management of research resources. A critical initial consideration is preventing duplication of effort. One area of concern for the committee that has also been high- lighted by others (GUIRR/NAS, 2009) is the lack of coordination of the food safety and defense research portfolios in the nation. Better coordina- tion will entail communication with other federal regulatory and research agencies (e.g., USDA’s FSIS, the Department of Defense, the National Science Foundation, NIH) that conduct salient activities or projects. Coordination of research efforts between the FDA and other entities could be expanded to the international sphere as well. Within the agency, the research function should not be organized around specific areas of expertise—such as micro- biologists who specialize in particular organisms (e.g., Salmonella, viruses) or scientists who specialize in certain techniques (e.g., molecular biology, biosensors)—or pet projects, but should be focused on key unanswered questions and problems whose resolution will have the greatest impact on improving the safety of the food supply by reducing the most significant public health risks. This means that well-trained researchers with specific disciplinary expertise will need to work interdependently in multidisciplinary teams that are designed to deal with particularly complex food safety issues. Individual research professionals will likely serve as members of more than one team. As is the case in academia, the FDA’s research program should evolve to become multidisciplinary, interinstitutional, collaborative, trans- lational, and flexible. At the same time, it is essential that certain key research thrusts be con-

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00 ENHANCING FOOD SAFETY tinued, with an eye to their use in support of risk-based decision making. An example is the development and application of advanced mathemati- cal modeling techniques. Likewise, qualified research staff will be needed to interpret data for appropriate use in support of risk-based food safety management. Other research areas may support the risk-based system tan- gentially and might better be outsourced. For example, improved analyti- cal methods are critical to the generation of quantitative data that can be used in risk modeling and to the monitoring of production and processing control points. In fact, a large proportion of the research done by CFSAN and NCFST is in the area of methods development. However, these centers may not be the best places for such work. It could be argued that FDA scientists have worked on methods development for decades with only limited success. Perhaps the methods development function would best be outsourced to the academic and private sectors, where cross-cutting innova- tive approaches ultimately lead to scientific and commercial success. It is also important to recognize that certain research efforts will be beyond the scope of current agency resources. For example, the collection of information on the prevalence or concentrations of microbes or chemi- cal contaminants across the farm-to-fork continuum and research on the efficacy of candidate interventions may require collaboration with industry. Likewise, the agency cannot be expected to have all the necessary in-house expertise to develop novel risk-modeling techniques, support advanced information technology capabilities, or keep pace with the rapidly develop- ing fields of proteomics and bioinformatics. Under these circumstances, the FDA should consider alternative means by which to foster research, such as interagency personnel agreements (for short-term expertise), public–private centers, and formalized extramural funding alternatives (e.g., cooperative agreements, grants and contracts, research institutes). Although the agency occasionally uses these mechanisms, the committee believes that additional efforts to reach out to the scientific community at large would provide much-needed expertise to solve complex food safety problems using innova- tive, multidisciplinary approaches. Further, engagement of entities outside of the FDA would go a long way toward promoting transparency of the agency’s research agenda. In conclusion, maintaining the appropriate balance between funda- mental and applied research is critical. The FDA should be true to its research mission, which focuses on applied and translational research in support of science-based decision making. The entire research program should be viewed as supporting the risk-based function; in other words, research should not exist just for its own sake. This means any fundamen- tal research that is undertaken should be aimed at answering questions relevant to controlling the highest-priority risks, and the outcomes antici- pated from such research must have relevance to risk management decision

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0 CREATING A RESEARCH INFRASTRUCTURE making. FDA scientists with interests in fundamental research should be encouraged to collaborate with academia, but the FDA’s research resources should be used mainly to support risk-based food safety priorities. KEY CONCLUSIONS AND RECOMMENDATIONS Results from research allow the FDA to fill data gaps and address uncertainties and thereby help refine its risk-based decision making. The committee applauds the recent consultation of the Science Board with regard to reviewing the research portfolios of CFSAN and CVM. Based on the information provided by the FDA, however, the committee concluded that the FDA’s current food safety research program is unfocused and fragmented. For almost a decade there has been no coordinated strategic planning initiative addressing all FDA food safety research programs as a whole. Coordination and leveraging of research at CFSAN, CVM, NCTR, ORA, and the five extramural research centers appear to be insufficient, and some overlap in their efforts is likely as a result. Many basic questions, such as the size of the overall research program or the balance of basic and applied research, need to be addressed if the FDA is to have a unified vision that reflects the recommended risk-based approach. The committee concludes that, in addition to enhancements to the FDA’s research portfolio, better coordination of the food safety and defense research conducted in the nation by government agencies, industry, and academia is needed. The committee offers the following recommendations to enhance the FDA’s research portfolio. Recommendation 6-1: The FDA should have a food safety research portfolio that supports the recommended risk-based approach. To this end, the agency’s current food safety research portfolio should undergo a comprehensive review. Following this review and with consideration of the agency’s broad strategic plan, the FDA should examine the rel- evance and allocation of its research resources by using public health risk ranking and prioritization. Future research should address the most pressing public health issues and directly support further char- acterization of risk and selection, implementation, and evaluation of interventions. In addition, research should be coordinated to prevent duplication of effort, especially for cases in which research efforts are better suited to the academic or medical sector. Once the review and planning of the agency’s research program have been completed, the committee recommends the following key implementa- tion actions.

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0 ENHANCING FOOD SAFETY Recommendation 6-2: Implementation of recommendation 6-1 requires reorganization of the FDA’s research portfolio, including reallocation of resources from irrelevant or poorly performing initiatives; hiring of new staff in critical areas and, where appropriate, retraining of existing staff; and identification of future resource needs to support risk-based food safety management. Although the committee recognizes the dif- ficulty of transferring scientists from one research focus to another, the FDA should foster an environment of fluidity in which teams of scientists can be formed with ease to address different research initia- tives as necessary. Recommendation 6-3: Keeping in mind that the FDA will not be able to address all important research needs, the agency should continue to utilize alternative funding mechanisms (e.g., cooperative agreements, university-based centers, contracts) based on a competitive, peer-review process. These efforts could be expanded by establishing a competitive extramural research funding program. REFERENCES CFSAN/FDA (Center for Food Safety and Applied Nutrition/U.S. Food and Drug Administra- tion). 2008. Food 00 Intramural Research Portfolio. Rockville, MD: FDA. CVM/FDA (Center for Veterinary Medicine/U.S. Food and Drug Administration). 2008. Three­Year Research Plan: FY 00−0. Washington, DC: FDA. FDA (U.S. Food and Drug Administration). 2009. FY 00 Congressional Justification: FDA Research Actiities. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/ Reports/BudgetReports/2009FDABudgetSummary/ucm116249.pdf (accessed January 22, 2010). FDA. 2010a. About the National Center for Toxicological Research. http://www.fda.gov/ AboutFDA/CentersOffices/nctr/default.htm (accessed March 2, 2010). FDA. 2010b. FDA Functional Actiity Tables: FY 00 Estimated. http://www.fda.gov/ downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM153841.pdf (accessed January 22, 2010). FDA. 2010c. FDA Functional Actiity Tables: FY 00 Omnibus. http://www.fda.gov/ downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM153840.pdf (accessed January 22, 2010). FDA. 2010d. FY 00 Congressional Justification: National Center for Toxicological Research. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/ ucm153374.htm (accessed January 21, 2010). FDA. 2010e. FY 00 Congressional Justification: FDA Research Actiities. http://www.fda. gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM153845. pdf (accessed January 22, 2010). FDA Science Board. 2009. Research Planning, Program and Facilities of the Center for Veteri­ nary Medicine. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ ScienceBoardtotheFoodandDrugAdministration/ucm176816.htm (accessed March 22, 2010).

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0 CREATING A RESEARCH INFRASTRUCTURE Glavin, M. 2008. Reitalizing ORA: Protecting the Public Health Together in a Changing World: A Report to the Commissioner. Washington, DC: FDA. GUIRR/NAS (Government-University-Industry Research Roundtable of the National Academy of Sciences). 2009. Technology Workshop on Food Safety and National Defense. http:// sites.nationalacademies.org/PGA/guirr/PGA_053569 (accessed April 7, 2010). HHS (U.S. Department of Health and Human Services). 2010. FY 00 President’s Budget for HHS. http://www.hhs.gov/asrt/ob/docbudget/index.html (accessed January 29, 2010). Khan, S. A., K. Sung, M. S. Nawaz, C. E. Cerniglia, M. L. Tamplin, R. W. Phillips, and L. C. Kelley. 2009. The survivability of Bacillus anthracis (Sterne strain) in processed liquid eggs. Food Microbiology 26:123–127. Kiess, A. S., P. B. Kenney, and R. R. Nayak. 2007. Campylobacter detection in commercial turkeys. British Poultry Science 48:567–572. Musser, S. 2009. Food Safety Research at FDA. Paper presented at IOM Committee on Review of the Food and Drug Administration’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. NCTR (National Center for Toxicological Research). 2009a. NCTR Strategic Plan: 00−0. Jefferson, AK: NCTR. NCTR. 2009b. FY 00 Accepted Publications. Jefferson, AK: NCTR. NCTR. 2009c. NCTR Food Publications 00−00. Jefferson, AK: NCTR.

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