Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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6 Creating a Research Infrastructure for a Risk-Based Food Safety System
6 Creating a Research Infrastructure for a Risk-Based Food Safety System
Pages 181-204
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From page 181... ...
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)
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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)
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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.
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As with research FTEs, the committee was unable to obtain information 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.
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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)
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From page 186... ...
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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From page 187... ...
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 animalderived products destined for the human food supply.
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. 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, aquaculture, and antimicrobial resistance of foodborne pathogens, although research scientists are frequently diverted from this focus to address emergency issues (FDA Science Board, 2009)
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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 support risk-based food safety management.
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Its research functions are conducted at the 13 ORA laboratories, 10 of which conduct food-related work. These 10 laboratories focus primarily on developing and validating analytical methods to meet the immediate needs of the field laboratories, work that is highly applied in nature.
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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.
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, and its unique state-of-the-art equipment, which includes a newly constructed biosafety level-2 pilot processing facility.10 Joint Institute for Food Safety and Applied Nutrition (JIFSAN) JIFSAN was established in 1996 as a partnership among the University of Maryland, CFSAN, and CVM.11 JIFSAN research was intended to focus primarily on risk analysis.
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The GAqPs training program was piloted in 2006, and three additional sessions were held in 2008–2009. A major effort at JIFSAN is devoted to supporting its Risk Analysis Training Program and maintaining the FoodRisk.org website.
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. 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.
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Nevertheless, CFSAN and NIH collaborate on a handful of projects, such as in the area of dietary supplements and long-term exposure to bisphenol A WEAKNESSES IN THE FDA RESEARCH PROGRAM The FDA food safety research portfolio is diverse and vast.
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From page 196... ...
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.
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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.
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as the FDA seeks to evaluate the efficacy 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.
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-- 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.
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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 tangentially and might better be outsourced.
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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.
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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.
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2009. Food Safety Research at FDA.
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