sharing of relevant data by all federal, state, and local food safety agen- cies. For example, in collaboration with other food safety agencies, the
FDA should develop and implement technologies and procedures that will ensure confidentiality and facilitate data sharing. Congress should consider amending the law, to the extent that legal changes are needed, to allow sufficient data sharing among government agencies.
REFERENCES
CDC (U.S. Centers for Disease Control and Prevention). 2009. Surveillance for foodborne disease outbreaks—United States, 2006. Morbidity and Mortality Weekly Report 58(22):609–615.
FDA (U.S. Food and Drug Administration). 2003. Memorandum of Understanding Between the Food and Drug Administration and the Centers for Disease Control and Preen
tion. MOU 225-03-8001. http://www.fda.gov/AboutFDA/PartnershipsCollaborations/
MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115068.htm (accessed May 15, 2010).
FDA Science Board. 2007. FDA Science and Mission at Risk. Report of the Subcommittee on Science and Technology. Rockville, MD: FDA.
FDA Science Board. 2009. Science Board Subcommittee Reiew of Information Technology.
Rockville, MD: FDA. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
ScienceBoardtotheFoodandDrugAdministration/ucm176816.htm (accessed April 14, 2010).
Frenzen, P. D., A. Drake, and F. J. Angulo. 2005. Economic cost of illness due to Escherichia coli O157 infections in the United States. Journal of Food Protection 68(12):2623−2630.
FSWG (Food Safety Working Group). 2009. Food Safety Working Group: Key Findings.
http://www.foodsafetyworkinggroup.gov/FSWG_Key_Findings.pdf (accessed February 18, 2010).
GAO (U.S. Government Accountability Office). 2009. Information Technology: FDA Needs to Establish Key Plans and Processes for Guiding Systems Modernization Efforts. Wash- ington, DC: GAO.
Havelaar, A. H., J. Braunig, K. Christiansen, M. Cornu, T. Hald, M. J. Mangen, K. Molbak, A. Pielaat, E. Snary, M. Van Boven, W. Van Pelt, A. Velthuis, and H. Wahlstrom. 2006.
Towards an Integrated Approach in Supporting Microbiological Food Safety Decisions.
Med-Vet-Net. Report No. 06-001. http://www.medvetnet.org/pdf/Reports/Report_06-001.
pdf (accessed May 15, 2010).
HHS (U.S. Department of Health and Human Services). 2009. Healthy People 00: The Road Ahead. http://www.healthypeople.gov/hp2020/default.asp (accessed February 18, 2010).
IOM (Institute of Medicine). 2003. Scientific Criteria to Ensure Safe Food. Washington, DC:Washington, DC:
The National Academies Press.
Kemmeren, J. M., M. J. Mangen, Y. T. P. H. Van Duynhoven, and A. Havelaar. 2006.2006. Priority Setting of Foodborne Pathogens: Disease Burden and Costs of Selected Enteric Patho
gens. Bilthoven, The Netherlands: RIVM Ministry of Public Health, Welfare and Sports.
http://www.rivm.nl/bibliotheek/rapporten/330080001.pdf (accessed January 30, 2009)..
Last, J. M., ed. 1995. A Dictionary of Epidemiology, 3rd ed. New York: Oxford University Press.
Majowicz, S. E., W. B. McNab, P. Sockett, S. Henson, K. Dore, V. L. Edge, M. C. Buffett, S. Read, S. McEwen, D. Stacey, and J. B. Wilson. 2004. The burden and cost of gastro- intestinal illness in a Canadian community. Journal of Food Protection 69:651–659.
Medeiros, L. C., P. Kendall, V. Hillers, G. Chen, and S. DiMascola. 2001. Identification and classification of consumer food-handling behaviors for food safety education. Journal of the American Dietetic Association 101(11):1326–1339.
Morse, D. L. 2009. Foodborne Disease Sureillance: Vignettes of a State Epidemiologist. Paper presented at Institute of Medicine/National Research Council Committee on Review ofInstitute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
NRC (National Research Council). 2009. Letter Report on the Reiew of the Food Safety and Inspection Serice Proposed RiskBased Approach to and Application of PublicHealth Attribution. Washington, DC: The National Academies Press.
Osterholm, M. T. 2009. Role of Foodborne Disease Sureillance and Food Attribution in Food Safety. Paper presented at Institute of Medicine/National Research Council Com- mittee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
Pilling, V. K., L. A. Brannon, C. W. Shanklin, A. D. Howells, and K. R. Roberts. 2008. Iden- tifying specific beliefs to target to improve restaurant employees’ intentions for perform- ing three important food safety behaviors. Journal of the American Dietetic Association 108(6):991−997.
Ruzante, J. M., V. J. Davidson, J. Caswell, A. Fazil, J. A. L. Cranfield, S. J. Henson, S. M.
Anders, C. Schmidt, and J. Farber. 2009. A multi-factorial risk prioritization framework for foodborne pathogens. Risk Analysis. Published online in advance of print. http://
www3.interscience.wiley.com/journal/122542673/abstract (accessed May 15, 2010).
Shogren, J. F., J. A. Fox, D. J. Hayes, and J. Roosen. 1999. Observed choices for food safety in retail, survey, and auction markets. American Journal of Agricultural Economics 81(5):1192−1199.
Taylor, M. R., and M. B Batz. 2008. Harnessing Knowledge to Ensure Food Safety: Opportu
nities to Improe the Nation’s Food Safety Information Infrastructure. Gainesville, FL:
Food Safety Research Consortium.
USDA/ERS (U.S. Department of Agriculture/Economic Research Service). 2009. Foodborne Illness Cost Calculator: Assumption Details and Citations for Salmonella. Washington, DC: USDA. http://www.ers.usda.gov/data/FoodBorneIllness/salmAssumptionDescriptions.
asp?Pathogen=Salmonella&p=1&s=4683&y=2006&n=1397187 (accessed January 30, 2009)..
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.
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
Center Research FTEs
Total Research Funding
Increase in Funding over Last Fiscal Year Center for
Food Safety and Applied Nutrition
30 (premarket applied research)a 140 (postmarket applied research)a
$9,478,000 (premarket applied research)a
$54,222,000 (postmarket applied research)a
+$374,000 (premarket applied research)b +$8,006,000 (postmarket applied research)b
Center for Veterinary Medicine
16 (premarket applied research)a 44 (postmarket applied research)a
$3,043,000 (premarket applied research)a
$8,195,000 (postmarket applied research)a
+$789,000 (premarket applied research)b +$1,208,000 (postmarket applied research)b
National Center for Toxicological Research
211 $58,745,000c
$1,625,000 specifically for Protecting America’s Food Supplyc
+$6,234,000c
+$1,625,000 specifically for Protecting America’s Food Supplyc
Office of Regulatory Affairs
Not available $1,100,000d No increasee
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.
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,
2 Personal communication, Chad Nelson, FDA, October 13, 2009.
3 The discussion in this section is based on the personal communication with Chad Nelson, FDA, October 13, 2009.
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).
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).
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:
• providing innovative and interdisciplinary research that promotes personal and public health
• developing novel translational research approaches to provide 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,
bioimaging, systems biology, bioinformatics, nanotechnology, food protection technologies, and biomarker development
• engaging with scientists across FDA and other government agen- 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 • participating in or leading national and international consortia for
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: Advance scientific approaches and tools to promote per- sonalized nutrition and medicine for the public
Goal 2: Develop science-based best-practice standards, guidance, and tools to incorporate toxicological advancements that improve the regulatory process
Goal 3: Conduct research and develop strategic technologies to protect the food supply
Goal 4: Conduct bioinformatics research and development in sup- port of FDA’s regulatory mission
Goal 5: Strengthen 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.
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).