Research Strategic Plan
Center for Food Safety and Applied Nutrition
Science and Research (CSR) Strategic Plan
The Center for Food Safety and Applied Nutrition (CFSAN), a science-based regulatory organization in the Food and Drug Administration (FDA), works to ensure that the nation’s food and cosmetics are safe, sanitary, and properly labeled. The center’s responsibilities are broad, dynamic, and complex, with a large proportion of the work devoted to addressing new and challenging issues:
- Globalization of the food supply chain;
- Changing industry processes; and
- Consumer preferences for fresh and minimally processed foods.
With food imports doubling in the period between 2002 and 2010, particularly challenging is the need to ensure the safety of imported foods. In 2011, 80 percent of seafood and 50 percent of fresh fruit consumed in the United States was imported--and consumer demand continues to rise for vegetables, coffee, tea, and cocoa from abroad. Traditional methods for sterilizing and disinfecting food must change to accommodate consumer preference for fresh and minimally processed foods. New technologies, such as the use of nanomaterials in cosmetics and food packaging, require whole new regimens for assessing safety. Further, ever-increasing consumer interest in dietary supplements poses special challenges for ensuring the safety of marketed products and their supply chain. Finally, unexpected contamination of food and cosmetics, whether by familiar agents or previously unrecognized ones, will continue to occur despite a new emphasis on preventing problems before they occur.
Through the Food Safety Modernization Act (FSMA), Congress mandates that we need a modern food safety system that both protects food as it moves from the farm to our nation’s tables and incorporates strong hazard prevention controls on imported and domestic food. The goal of FSMA is to introduce safety standards and practices aimed at preventing contamination of food before it occurs, with standards grounded in the latest food-safety research and science. By setting science-based preventive control standards for the way industry produces, distributes, and markets food, the government can better protect products entering the stream of commerce. CFSAN is a major participant in this effort to establish shared responsibility and accountability for food safety.
In an effort to address these growing food safety concerns and to implement new FSMA-mandated regulatory responsibilities, CFSAN developed the Center for Food Safety and Applied Nutrition Science and Research (CSR) Strategic Plan to effectively address current and future challenges. CFSAN’s research helps to inform the center’s regulatory role as it applies to food and cosmetic safety, food defense, and applied nutrition. The CSR Strategic Plan accounts for our regulatory responsibilities and trends in the food and cosmetic sectors, as well as incorporating new responsibilities for the Agency resulting from FSMA. Notably, the CSR Strategic Plan is fully aligned with FDA's strategic priority to Implement a New Prevention-Focused Food Safety System to Protect Public Health and the goals and strategies of FDA’s new Office of Foods and Veterinary Medicine (OFVM).
Strategic Goals and Research Outcomes Direct CFSAN's Regulatory Science and Research
CFSAN identified five strategic goals that would have the greatest impact for modernizing the nation's food safety system and protecting public health. These are:
- Better control and prepare for hazards
- Create faster and validated methods
- Influence consumer behavior toward healthy dietary choices
- Develop leading edge technology for understanding and evaluating scientific information
- Improve our adaptability and responsiveness
To accomplish these strategic goals, we designated research outcomes, signifying that the results of our research are measurable outcomes useful for regulatory science and directed to accomplish critical agency missions. We then prioritized the research outcomes based on public health needs, regulatory requirements, and policy imperatives, in order to make optimal use of our resources. The following are CFSAN's strategic goals for science and research with examples of their applicable research outcomes.
Strategic Goal 1: Better control and prepare for hazards
This goal captures the majority of CFSAN’s research and collaborative activities. To better control and prepare for hazards, we conduct research that supports regulatory policy, rules, guidance, and decisions; and we sustain and build critical research capabilities. We have identified six research areas for sustaining or building the research capacity needed to support our strategic goals: microbiology, analytical chemistry, toxicology, food science, bioinformatics, and nanotechnology.
CFSAN’s research efforts involve detecting and analyzing microbial pathogens and chemical contaminants in foods and cosmetics and evaluating the safety of food ingredients. The research focuses on food additives; dietary supplements; allergens and gluten; nanoparticles in cosmetics; and retail foods; and on the five FDA-regulated commodities most susceptible to hazards—fresh produce, eggs, dairy products, seafood, and spices. The following are examples of expected research outcomes to better control and prepare for hazards.
Examples of Research Outcomes
- Improved preventative controls for reducing or eliminating Salmonella and pathogenic Escherichia coli
- Better detection and quantitation of allergens and gluten in foods
- Safety assessment of nanoparticles used in cosmetics
- Toxicological data on dietary supplements of concern
- Validated methods to accomplish targeted and non-targeted screening of chemical composition in botanical dietary supplements
- In vivo assays for marine biotoxins replaced by in vitro models for toxicity assessment in seafood
- Improved risk modeling, including risk assessment of the most hazardous microbial agents and chemical compounds
- Improved recovery of viruses from fresh produce and seafood
Strategic Goal 2: Create faster and validated methods
CFSAN seeks faster technologies to screen and identify potentially unsafe foods, whether domestic or imported. Our goal is to reduce the time it takes to detect contaminants and adulterants in foods and to validate all of the regulatory methods we use.
Examples of Research Outcomes
- Validated methods for detecting Salmonella and Escherichia coli in fresh produce
- Increased specificity and reduced time for methods to sub-type and track food pathogens during outbreaks
- Two-day detection of norovirus and hepatitis A in foods
- Validated and harmonized methods for detecting Vibrio species in seafood
- Methods for screening chemical contaminants in products at greatest risk
Strategic Goal 3: Influence consumer behavior toward healthy dietary choices
Nutritional information first appeared on food labels more than 100 years ago. Now mandatory, nutrition fact labels are continually being improved. Nevertheless, in light of growing problems of obesity, diabetes, and cardiovascular disease, it is not yet clear to what extent consumers use this information to select their diets.
Examples of Research Outcomes
- Promote research to measure the health benefit of adhering to 2010 Dietary Guidelines for Americans
- Communication and change in behavior practices evaluated for effectiveness
- Evaluation of health benefits resulting from consumer dietary changes
Strategic Goal 4: Develop leading edge technology for understanding and evaluating scientific information
Modern technologies provide high volumes of data that must be quickly accessed and analyzed. Our goal is to develop leading edge technology for understanding and evaluating this data. For example, CFSAN’s responsibilities require developing sophisticated information technology for the following:
- Microbial characterization and sub-typing to improve foodborne outbreak detection and response
- Assessing risks from hazards targeted to priority food commodities
- Using computational toxicology to assess the safety of food additives
Strategic Goal 5: Improve our adaptability and responsiveness
Achieving CFSAN research goals depends not only on the quality of research but also our organizational effectiveness. Strategic goal 5 calls for organizational and operational improvement in adapting to change and responding to emergencies. The goal recognizes that only a prepared and resourceful organization can manage serious issues confronting our food supply in an increasingly complicated and global food market. Outcomes that support this goal include the following:
- Alignment of research tasks to respond to current regulatory needs of CFSAN
- Prioritization of research outcomes to adapt to changing needs for regulatory science
- More flexibility in procuring laboratory supplies and services
- Better planning to accommodate variability in funding research
Collaboration with other regulatory and research organizations is yet another strategy that CFSAN uses to enhance adaptability and responsiveness. For needed expertise, our scientists work with colleagues in academic institutions, federal and state food safety enterprises, and other scientific organizations, often through formal Collaborative Research Agreements or Cooperative Research and Development Agreements (CRADAs). CFSAN’s Centers of Excellence (COEs) program is the prime route the center uses to enhance its ability to reach a larger portion of the global food safety community. CFSAN currently supports four COEs: National Center for Food Safety and Technology (NCFST) for food science and processing technology; Joint Institute for Food Safety and Applied Nutrition (JIFSAN) for technology transfer and training food safety scientists; The FDA COE for Botanical Dietary Supplement Research at the National Center for Natural Products Research (NCNPR) for research on botanical supplements; and Western Center for Food Safety (WCFS) for fresh produce safety research.
Strategic Outcomes guide the research toward supporting a modern food safety system
The CSR Strategic Plan aims to strengthen the science and research needed to ensure the safety of the nation's food and cosmetics. Regular reviews of progress and a yearly process of designating and prioritizing research outcomes assure that the plan continues to meet current needs and that we use our staff and resources efficiently and effectively. The CSR Strategic Plan also incorporates longer term strategic outcomes that improve the overall science base for CFSAN's regulatory mission. Principal strategic outcomes for the research in analytical chemistry, microbiology, and toxicology are:
- Methods to screen for the top potential chemical contaminants in priority products
- Non-targeted analytical methods for screening chemical hazards
- Detectors for microorganisms, chemical hazards, and economic adulterants for use in field inspections
- Use of time-consuming microbiological culture methods minimized or eliminated
- Speed and effectiveness of sample preparation continuously improved
- Existing in vitro and in vivo methods made applicable to measuring dose response
- Continuous improvement in risk modeling and data acquisition capability
The Center for Food Safety and Applied Nutrition Science and Research Strategic Plan provides a blueprint for conducting mission-relevant research based in strategic goals, prioritized research outcomes, and strategic outcomes. Through consistent and sustained planning, CFSAN research can better provide critical information for preventing and controlling hazards that threaten the nation’s food supply, dietary supplements, and cosmetics. As consumer expectations rise and regulatory challenges intensify in the current global economy, the roles of science and research become even more essential.