HFP Priority Research, Data, and Method Needs

FDA’s Human Foods Program has compiled the following list of priority research, data, and method needs which, if fulfilled, will help FDA better understand the underlying factors that may cause or contribute to health risks from HFP regulated products.

These research, data, and method needs are provided for researchers interested in pursuing science that is useful to advancing the safety of the U.S. food supply. The list may also be helpful for writing grants to agencies that fund food safety research, such as USDA’s National Institute of Food and Agriculture, the National Institutes of Health, and others identified through Grants.gov. Some of the listed priorities may be the subject of current research projects.

While HFP prioritizes these areas of scientific inquiry, any data collected and conclusions reached in studies related to these areas would be subject to HFP review prior to use in policy, planning, or resource allocation decisions.

This list will be updated periodically. Should you have questions regarding these priorities, please contact Shaun MacMahon at shaun.macmahon@fda.hhs.gov.  

Nutrition

1. Enhance Approaches for Nutrient Analyses
   • Create a standardized and validated safety study protocol to evaluate the use and bioavailability of ingredients in infant formula.
   • Determine the impact of water activity, pH, and hydrocolloid type (e.g., gelatin, pectin, and/or agar) on the stability of micronutrients/bioactives in gummy dietary supplements.
2. Increase Understanding of Biological Effects and Outcomes of Nutrients and Ingredients
   • Elucidate the mechanisms between consumption of foods considered ultra-processed and negative health outcomes. 
   • Elucidate the mechanisms of action of nutrient and chemical contaminant exposures from food (as well as nutrient and contaminant statuses) in the human body as they pertain to normal biological functions and health, including child neurodevelopment. 
   • Explore the impact of source material (e.g., plant cell culture) on the identity and safety profile of certain dietary supplement ingredients.
   • Monitor and assess nutrient intake and nutritional status using: National Health and Nutrition Examination Survey (NHANES) — calorie, total fat, sat fat, polyunsaturated fatty acids (PUFA), monounsaturated fatty acids (MUFA), trans fat, protein, dietary fiber, carbohydrate, and sugar (total and added) vitamins A, C, D, E, folate/folic acid, calcium, potassium, iron, zinc, iodine, potassium, magnesium, and sodium; as well as validated biomarkers of intake and disease risk. 
   • Study the results and experimental designs (e.g., duration, feed rate, dietary energy density, macro- and micronutrient compositions, animal husbandry, experimental outcomes, sampling, and statistical analyses) from feeding studies in piglets to determine if piglets are a better animal model than rats for infant absorption of high quality proteins found in infant formulas. 
   • Evaluate the existing evidence on single actions, interactions, compound effects, and/or synergistic effects of nutrients/bioactives and contaminants, including comparison/collation of foundational knowledge on biological mechanisms of nutrients and contaminants in the human body.

Human Behavior, Perceptions, and Attitudes

• Collect data on consumer/stakeholder understanding, perceptions, and preferences regarding label statements to convey the presence of major food allergens from novel food ingredients and how to provide meaningful statements (e.g., advisory, free-from) regarding threshold levels in order to help direct the agency’s next steps for labeling in these areas. 
• Determine stakeholder consensus on risk-based reference doses for allergens and effective allergen labeling. 
• Study consumer perceptions and understanding of food chemicals and additives. 
• Collect and evaluate data and information on consumer understanding of FDA educational materials regarding food chemicals and additives.
• Study consumer knowledge of toxic elements and relevant consumer messaging. 
• Expand consumer research and data to inform development of messaging, implementation of outreach, testing of effectiveness in the population, and refinement for population groups. 
• Monitor and assess changes to intake/status and the marketplace in response to labeling changes and other FDA nutrition initiatives to assess the effectiveness of FDA’s policies and regulations in supporting healthy dietary practices for consumers.  
• Monitor manufacturer changes to the foods offered for sale in the U.S. in response to information on the Nutrition Facts label, ingredient statement, and label claims information (e.g., health claims, nutrient content claims, front-of-pack, etc.) from sources such as Food Data Central. 
• Increase our understanding of consumer/caretaker perceptions and understanding of statements such as “Animal-Free Dairy Milk” versus “Milk”. 
• Collect data on consumer response to novel food ingredients including product labeling and adverse events. 
• Study the effectiveness of food recall and foodborne illness outbreak communications.
• Study consumer food safety practices related to: 1) food handling (e.g., temperature distribution in home refrigerators); 2) the use of cooking instructions; 3) home cross-contamination; and 4) use and preparation of not ready-to-eat (NRTE) foods. 
• Study consumer practices related to the consumption of certain foods (e.g. enoki mushrooms), including raw vs. cooked and dried vs. fresh; whether consumers view certain foods as potential sources of illness; and consumer confidence in the safety of at-home food preparation. 
• Conduct surveys to understand the usage of certain products that would be regulated under ready-to-eat (RTE) and consumer package group (CPG) guidance, similar to the previous studies on frozen vegetables usage, focusing on product categories in order to gain additional insights on consumer trends.

Microbiological Food Safety

1. Screening/Detection Methods
   • Conduct targeted sampling of specific commodities to attain baseline prevalence estimates of microbial pathogens to inform compliance and risk management activities.
2. Hazard identification and Prevention
   • Study ways to reduce microbial hazards through processing. 
   • Evaluate the effectiveness of dry and wet cleaning sanitation methods for: 1) pathogen control in the processing of low moisture foods; 2) pathogen control in equipment and tools used in harvesting produce; and 3) removal of allergens on shared equipment. 
   • Determine how characteristics that are: 1) inherent to the food; 2) formulation-based; and 3) affected by the processing stage, impact the presence and/or growth of microbial pathogens.
   • Study the impacts of seed treatments and growth conditions on Salmonella in sprouts.   
   • Evaluate Salmonella and Listeria survival on fresh produce (e.g. carrots, onions). 
   • Study retail conditions and their effects on survival of Listeria on specialty mushrooms and Salmonella on peaches. 
   • Study the impact of storage and drying conditions on survival of Shiga Toxin-producing Escherichia coli (STEC) in wheat. 
   • Evaluate levels of Enterobacteriaceae, a microbial indicator for insanitary conditions, in dried/powdered botanicals over time. 
   • Evaluate the change in levels of pathogenic bacteria, such as Salmonella, in dried/powdered botanicals over time. 
   • Study potential or existing strategies used for the reduction of various bacterial spore populations in raw milk for their effectiveness in reducing risk associated with C. botulinum spores in milk or milk powders.
   • Determine whether C. botulinum toxins are produced in foods (oysters, cold brew coffee, and modified atmosphere packaging (MAP) products) stored under temperature abuse conditions.  
   • Increase the number of enteric virus sequences in FDA’s publicly accessible ViroTrakr nucleic acid sequence database. 
   • Develop Whole Genome Sequencing (WGS) as an epidemiological tool to facilitate Vibrio illness investigations. 
   • Determine what level of single nucleotide polymorphism (SNP) heterogeneity exists between Vibrio species and determine an appropriate SNP cutoff for Vibrio illness investigations to account for spatial and temporal variability. 
   • Determine the genomics underlying the presence and persistence of pathogens within food production facilities. 
   • Perform bioinformatic analysis of large collections of whole genome sequence data from isolates from FDA regulated facilities. 
   • Determine if Global Information System (GIS) tools are available or need to be developed to compile and visualize bacterial, viral, and toxic algae data in federal shellfish harvesting waters. 
   • Evaluate and/or develop models to complement GIS tools for suitability assessment of shellfish harvest waters. 
   • Apply GIS tools to improve bacterial, viral, and marine biotoxin prediction and mitigation strategies for molluscan shellfish harvest.

Food Chemical Safety, Dietary Supplements, and Innovation

1. Screening/Detection Methods
   • Perform targeted sampling of specific commodities to attain baseline prevalence estimates of chemical hazards to inform compliance and risk management activities. 
   • Evaluate the addition of an economically motivated adulteration vulnerability module in the current AI and machine learning models developed for food safety hazards.
   • Evaluate the prevalence of economically motivated adulteration of high value oils, including avocado oils. 
   • Develop methods to identify syrup markers in adulterated honey. 
   • Determine concentrations of micronutrients/bioactives across the major matrix types of gummy dietary supplements over time.   
   • Collect and evaluate data on safety factors (e.g., immunogenicity, potential byproducts) relevant to the review of dietary ingredients and supplements from novel sources, including transgenic products and residues, bacteria, recombinant proteins, and plant cell cultures.
   • Monitor PFAS concentrations in different foods including reductions in PFAS concentrations resulting from interventions and PFAS mitigation techniques. 
   • Evaluate PFAS analytes and concentrations found in the most consumed types of seafood, including differences in PFAS in domestic versus imported seafood, wild-caught versus aqua-cultured, raw versus processed, as well as differences in anatomical distribution of PFAS in seafood. 
   • Facilitate method development or identify existing methods to monitor food packaging for the presence of grease-proofing agents containing PFAS.
   • Develop microscopy methods for characterization of standard single and mixed polymers of microplastics in solution.
   • Develop methods to differentiate microplastics from endogenous materials in food.
   • Collect sampling data for methylmercury in seafood. 
   • Collect sampling data for toxic elements in children’s foods. 
   • Gather information on: 1) manganese concentrations in liquid and powdered infant formula, currently on the market; 2) manganese concentrations in the water supply of various geographical regions in the U.S.; and 3) manganese toxicity in infants (e.g., from human clinical studies and preclinical studies in animal models).
   • Conduct environmental allergen sampling studies to systematically evaluate the effectiveness of allergen control procedures and sampling strategies to characterize unintended allergen presence in food and food contact surfaces. 
   • Develop in vitro assays (NAMs) for screening chemicals for potential developmental neurotoxicity. 
   • Develop in vitro assays (NAMs) for screening emerging chemicals of concern, found in food and dietary supplements, for hepatotoxicity.
2. Characterization and Quantification
   • Identify species-specific and process-specific sources of per- and polyfluoroalkyl substances (PFAS) for appropriate control. 
   • Identify foods that contribute most to PFAS dietary exposure based on PFAS concentrations and dietary consumption estimates and develop interventions and mitigation techniques to reduce PFAS concentrations in these foods. 
   • Develop and optimize an improved process for Caribbean ciguatoxin standard reference material production and quantification. 
   • Develop an improved understanding of how plants uptake toxic elements and of mitigation strategies based on this information. 
   • Evaluate the sorption of the chemical compounds of interest (surrogates) in polyolefin and polyethylene food contact materials. 
   • Develop science-based approaches to assessing novel proteins, including understanding drivers and trends in food consumption and associated risk factors driving allergic response. 
   • Develop and characterize analytical methods for quantifying novel or alternative protein sources in FDA regulated products. 
   • Develop an improved method for determining fatty acid and sterol composition in high-value oils (e.g., olive oil, avocado oil, etc.). 
   • Using a meta-analysis approach and artificial intelligence, retrospectively compare nutritional studies to identify if chemical food additives may be associated with negative health changes and identify which additives may be implicated or, conversely, demonstrate that food additives do not have a measurable impact on the health metrics of nutritional studies. 
   • Determine the current use level and analytically characterize the residual concentration of potassium bromate in baked goods in the U.S. 
   • Analytically determine the concentration of 4-MEI in Class III and IV caramel colors and foods manufactured with these colors as consumed. 
   • Determine the chemical differences between the same foods, made with acrylamide mitigation strategies and made without acrylamide mitigation strategies.
   • Explore the impact of source material (e.g., plant cell culture) on the identify and safety profile of certain dietary supplement ingredients
3. Hazard Identification and Prevention
   • Study ways to reduce chemical hazards through processing. 
   • Elucidate the mechanisms of action in the human body of nutrients and chemical contaminants from food (as well as nutrient and contaminant status), as they pertain to normal biological functions and health, including during child neurodevelopment. 
   • Collect and evaluate data on NAMs and risk assessment methods that can improve the identification or prediction of safety signals in ingredients with limited safety data.

Risk Assessment

1. Risk Across Various Population Groups
   • Determine the impact of foodborne illness outbreaks on people in the U.S. population with less access to a variety of foods on a consistent basis. 
   • Analyze the exposure to toxic elements during pregnancy/lactation. Study dietary shifts from pre-pregnancy to pregnancy that could increase or decrease toxic element and nutrient exposures. 
   • Collect data and information about contaminants in foods (e.g., lead, Listeria), to better characterize the factors that influence prevalence and levels in foods as well as the public health impact of dietary exposure, including variability within the population.
2. Impact of Manufacturing Procedures, Practices, and Processes on Risk
   • Conduct environmental allergen sampling studies to systematically evaluate the effectiveness of allergen control procedures and sampling strategies to characterize unintended allergen presence in food and food contact surfaces. 
   • Study filtration and other treatments for reducing the risk of allergen cross-contact due to use of shared fryers/frying oil.  
   • Identify the critical factors influencing pathogen reduction during blanching and other thermal processes.  
   • Determine the prevalence and levels of pathogens and virus contamination as well as to what extent chemical hazards, including allergens and antimicrobial drug residues, are associated with: 1) controlled environment agriculture, e.g., aquaponics, hydroponics, and aeroponics; and 2) foods produced using shared processing equipment/facilities. 
   • Identify effective manufacturing processes that reduce the level of chemical hazards in FDA regulated products. 
   • Determine the impact of milling on removal of surface chemical contaminants from rice and other grains. 
   • Evaluate the impact of filtration treatments on toxic element levels in beverages.  
   • Identify surrogates needed to evaluate washing procedures used to produce recycled polyolefin and polyethylene food contact materials.
   • Determine the impact of nanoparticle type, polymer composition, food composition, and processing on nanoparticle migration. 
   • Study the impact of polymer polarity, nanoparticle composition, and emerging food sterilization processes (such as e-beam irradiation) on the quantity and form of nanoparticle-derived material that migrates from packaging materials. 
   • Combine internal and relevant external data (e.g., analytical results, import and trade data, food adulteration incidents, food production volume, disaster and crisis data, weather, economic data, etc.) to develop improved models for predicting economically motivated adulteration.

Other

• Evaluate the prevalence of economically motivated adulteration of seafood products, including seafood short-weighting and seafood species substitution.