U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
August 28, 2000

FDA/CFSAN Priority Research Needs

Dear Stakeholder:

As part of the Center for Food Safety and Applied Nutrition's research planning process, we have developed a list of priority research needs for the new fiscal year. The Center is mindful that as a leader in food safety, communicating these needs to other agencies and to its partners in academia and industry is critical to the achievement of its goals.

The scope of the research needs outlined in this document extends beyond the available resources in CFSAN. Nevertheless, through interaction and collaboration between our sister agencies and our partners in industry and academia, our hope is that these critical food safety research areas will be addressed.

We will be happy to provide you with more information on any or all of the research areas identified. Likewise, we are always pleased to meet with representatives from our sister agencies and our partners in industry and academia.

Thank you in advance for your consideration.

FDA/CFSAN's priority research needs, in support of its regulatory mission include:

1. Providing FDA's field investigators and laboratories with more sensitive, reliable, and cost-effective tools, particularly sampling methodologies, for analyzing food and environmental samples (e.g., high priority commodities include produce, eggs, and seafood) for microbial pathogens, where frequency and extent of contamination are expected to be low.
2. Developing a general RT-PCR based detection method for all foodborne pathogenic viruses from a single food sample, utilizing the essential elements of Differential Display Technology and identification by hybridization to a DNA array (i.e., "chip" technology). Further refinement to genotype viral strains would facilitate molecular epidemiological analysis (i.e., VirusNET) in outbreak situations.
3. Providing commodity specific data to enhance science-based guidance to industry on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) that will help assure the safety of fresh and fresh-cut produce. Information on the efficacy of innovative on-farm prevention strategies under commercial conditions is of particular interest.
4. Developing quantitative models for the survival and inactivation of foodborne pathogens in manure used for crop fertilization. Knowledge gained should lead to accelerating the elimination of pathogens via the composting of manure, indicate a simple means for farmers or manure suppliers to monitor the effectiveness of the process, and provide "user friendly" guidelines for the safe use of manure.
5. Developing parameters for effective use of different technologies in reducing pathogenic microorganisms in or on produce, sprouts, juice, and seafood, used as stand-alone methods or in combination schemes (see http://www.cfsan.fda.gov/~comm/ift-need.html). These data will allow FDA to develop improved industry guidance, set performance standards, and effectively evaluate industry's HACCP plans.
6. Identifying indicator organisms, quality attributes, and other product characteristics that could be used as markers of increased contamination by microbial and viral pathogens, including protozoan parasites. These data will allow FDA to provide guidance on cost-effective monitoring schemes to its field investigators and to industry.
7. Identifying the natural environmental parameters that affect incidence and prevalence of microbial pathogens in seafood harvested in the wild. These data will support FDA's efforts to develop public health policy and provide science-based guidance to state health/food safety agencies and industry.
8. Providing scientific information needed to develop and implement more effective egg safety risk management programs for Salmonella Enteritidis control, surveillance, and education. These data will support the goals of the President's Food Safety Council "Egg Safety from Production to Consumption: An Action Plan to Eliminate Salmonella Enteritidis Illnesses due to Eggs" (see http://www.foodsafety.gov/~fsg/ceggs.html).
9. Providing a clear physiological and molecular (evolutionary) understanding and assessment of the impact and significance of mechanisms of microbial antibiotic resistance (AR) emergence, acquisition, spread, persistence and decline, as it relates to the ecology / production / processing / handling of FDA regulated foods (e.g., produce) and the emergence of new foodborne pathogens (e.g., Salmonella Typhimurium DT104, Escherichia coli O157:H7).
10. Acquisition of specific data to support assessment of public health risks posed by a variety of toxins (e.g., algal, fungal, and bacterial toxins) that occur in seafood, produce, grain, and other food products. These data will enable FDA to prioritize allocation of resources to specific research and regulatory activities, based on the magnitude and nature of specific risks.
11. Identification and evaluation of relevant characteristics of different forms of product packing and handling on the safety of a variety of foods, especially those whose processing does not include a terminal inactivation step (e.g., modified atmosphere packing of minimally processed and "souse vide" products).
12. Developing modeling techniques to assess microbial behavior in various foods, human exposure and dose-response relations to certain foodborne pathogens (e.g., enumerative detection methods for pathogens), potential risk of those pathogens causing human illness, and the setting of safety performance standards to regulate microbial content of food.
13. Establishing standards related to techniques for assessing the safety of foods (and feeds) developed using biotechnology at the pre-market level. FDA needs to understand the underlying basis of allergic mechanisms in humans and have the means to assess the potential allergenicity of new proteins introduced into foods. Additionally, FDA must be able to assess the risk potential for "unexpected effects" in bio-engineered foods, such as the lowering of nutrient levels important for human health or the raising of endogenous toxicants and anti-nutrients.
14. Developing advanced analytical methods and enhanced sampling protocols for use in the surveillance for pesticide residues of both domestic and imported foods. With the passage of the Food Quality Protection Act (1997), which mandated that EPA review all existing tolerances as well as institute measures to provide additional protection to children, it is likely that tolerances for many pesticides will be reset at lower levels. FDA must have the capability to monitor the food supply for pesticide residues at these lower levels.
15. Developing rapid, sensitive, and cost-effective analytical methods for determining dioxins in foods.
16. Developing analytical methods to exclude from the marketplace those dietary supplements and dietary supplement ingredients that contain adulterants, poisons, mycotoxins, pesticides, heavy metals (e.g., lead, arsenic) and/or substances that may render the product unsafe.
17. Conducting analyses of infant formula and developing methods needed for selected essential and non-essential ingredients, including new ingredients (e.g., bio-engineered fat sources, fructo- oligosaccharides [fiber-"like"]), to support compliance and enforcement activities and to assess the safety of new formulas within 90 days. FDA must set national standards for the factors that can influence both nutritional quality and overall safety of infant formula, and is especially concerned about products targeted to special populations, such as the pre-term infant or infant suffering from a particular disease or medical condition (e.g., metabolic disorders).
18. Developing methods for medical foods to substantiate product safety, validate label claims, facilitate reviews of pre-market notifications, and assist in the development of GMPs.
19. Developing conventional foods-related analytical methods to determine soy protein in soy health claim-bearing products, trans fatty acids in foods bearing trans-fat free claims, inulin and fructo- oligosaccharides in "dietary fiber"- containing health claims, and isomers of vitamin K for which Regular Daily Intakes (RDIs) are under consideration.
20. Developing methods to assess the safety of bacteria used as probiotics (i.e., viable microorganisms that are beneficial to human health). Such studies should include the evaluation of health effects, mechanism of action, and stability characteristics of the specific strain (or strain combinations), the definition of physiologically relevant consumption levels, and the definition of the active principle (whole cell, viable / nonviable cell, cell components) of a probiotic product.
21. Determining the phototoxicity (or general toxicity) of botanical ingredients, such as aloe vera [aloe emodine], hypericin [St. John's Wort], berberine, and pigments used in tatoos and permanent make-up. Additionally, toxicological evaluations are needed on the short-term photo effects of topically applied retinol and retinol derivatives and the relative sensitization potential and physical adherence properties of ethyl and methyl methacrylate in cosmetic nail preparartions.
22. Developing and validating analytical methods for pesticide residues in botanicals and certain animal-derived materials (mink oil, lard, lard derivatives) in "cosmetics."
23. Determining the population trends with respect to food safety knowledge, attitudes, and practices, especially behaviors that may be significant risk factors for foodborne illness (e.g., food consumption, in-home food preparation and handling). Moreover, FDA needs information on consumer practices as a result of various food safety labeling and education initiatives (e.g., FDA warning statements on unpasteurized juices, the Fight Bac education campaign, USDA labels for safe handling instructions on shell eggs). These studies will help FDA devise educational activities, guidance, and appropriate labeling messages.
24. Developing and validating accurate, rapid, and cost-effective analytical methods for determining sulfites in the various food types in which sulfites are used. Additionally, available or new methods should be assessed / developed for the capability of distinguishing between added sulfite and sulfur compounds naturally present in some foods (e.g., garlic, onion). Particular emphasis is needed on the concerns related to sulfiting agents, such as determining what reversibly bound forms of sulfite are present in food and, of these forms, which ones produce reactions in sensitive individuals.
25. Estimating the dietary intake of food contact substances to support premarket safety review, by obtaining analytical data from migration tests on actual finished materials or on substances that maximize migration of additives / components used in finished materials. These data should be used in developing experimental or computational models of "worst-case" migration scenarios.
26. Determining the types of recycled plastic materials suitable for use in food packaging, including any necessary limitations on material source(s), physical property parameters and levels of residual contaminants, or on the application of barrier layers of virgin grade resin to the recycled plastic. Additionally, FDA needs analytical methods to determine the levels of the metals (e.g., Pb, Cr, Cd, Hg, and As) ubiquitous in packaging from both virgin and recycled paper / paperboard pulp.
27. Extending existing computational toxicology models for structure-based prediction of likely toxic effects of chemicals in animal and microbial testing to predict dose-response behavior. For example, developing structure activity analyses for estimating carcinogenic potency and predicting toxicity of dietary supplement components that are structurally similar to drugs. Further expansion and validation of computational models would support efficient FDA decision making and resource allocation.
28. Estimating exposure to hormonally active agents (HAAs) (e.g., estrogens), through analytical methods development and modeling, in a wide variety of foods and food packaging materials obtained from market surveys (i.e., legal grocery stores) and packages collected from FDA's Total Diet Study. FDA needs to accurately determine estimated daily intakes of HAAs as part of its food additive safety review. The knowledge gained should help to reveal consumption patterns to any sub-populations (e.g., infants, pregnant females) that may have high intakes.
29. Development of nutritional testing schema that are based on the nature and predicted consumption pattern of macro-ingredient food additives. By definition, a macro-ingredient may constitute a significant portion of the diet; hence, traditional application of a safety factor to a "no effect level (NOEL)" in animal studies for safety assessments in food additive petitions (and their review) is not feasible. FDA must give guidance regarding the appropriateness of such testing.

Hypertext updated by cjm 2000-SEP-21