Center for Food Safety and Applied Nutrition
Science and Research Strategic Plan
The Center for Food Safety and Applied Nutrition (CFSAN) is a science-based regulatory organization within the Food and Drug Administration (FDA) that has the responsibility to promote and protect the public’s health by ensuring that the United States food supply is safe, secure, sanitary, and properly labeled, as well as ensuring the safety and proper labeling of dietary supplements and cosmetic products. CFSAN’s mission is more critical than ever, given the expansive scope of CFSAN’s regulatory mandate: the center currently regulates approximately $417 billion worth of domestic food, $49 billion worth of imported foods, and over $60 billion worth of cosmetics sold across state lines. Further, globalization, new technologies, and increased consumer demand for fresh and imported food products are driving a need for new tools and standards to regulate a more complex and diverse food supply and cosmetic industry. Given these pressures and scope of regulatory authority, CFSAN is directing resources toward targeted and strategic scientific research that supports regulatory decision making and meets the demands of emerging and existing food and cosmetic safety issues in the 21st century.
As CFSAN continues to implement the Food Safety Modernization Act (FSMA), the center is focused on setting science-based preventive control standards for the way industry produces, distributes, and markets food in order to strengthen the nation’s food safety system. In 2013, CFSAN published six proposed regulations aimed at preventing contamination of food. The center will finalize these regulations and utilize new enforcement tools authorized by FSMA. Grounded in the latest science, these authorities will enhance the agency’s ability to implement a new prevention-focused food safety system.
In an effort to address current food safety challenges and to implement new FSMA-mandated regulatory responsibilities, CFSAN has developed the CFSAN Science and Research Strategic Plan (the “strategic plan”). 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 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 the FSMA legislation. At the core of CFSAN’s mission is a responsibility to protect consumers using the best possible science to support its regulatory activities. This strategic plan provides tactical direction to ensure that the center is using the best methods and tools available to advance food and cosmetic safety and that regulatory decisions have a sound science footing. In addition, the 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 Office of Food and Veterinary Medicine (OFVM).
Support CFSAN’s mission to protect and promote public health by addressing critical knowledge gaps through research needed to support regulatory decision making.
CFSAN identified six strategic goals that would have, in the near term, the greatest impact for modernizing the nation's food safety system and protecting public health. These are:
- Develop and evaluate intervention and preventive control strategies for microbial and chemical hazards in CFSAN-regulated products
- Develop and implement screening methods for use in field laboratories to improve the capacity for detection of chemical contaminants
- Advance scientific leadership in bioinformatics to further the agency’s regulatory and public health decision making
- Integrate and apply modern toxicological approaches to support regulatory and public health decision making on chemical hazards in foods, dietary supplements, and cosmetics
- Advance diet and health research that contributes to the development of science-based policies and communication strategies
- Engage our Centers of Excellence (COEs) and stakeholders to enhance FDA’s science and research resources to maximize public health benefit
Each of these strategic goals will be discussed in greater detail below.
Strategic Goals Development
Every three years, CFSAN evaluates and updates our strategic plan for science and research to ensure that the vision for the center’s science and research enterprise is targeted toward addressing current regulatory needs and evolving public health priorities. This strategic plan is in its second iteration following the 2011-2014 plan, which laid a foundation for developing faster, validated methods and a process for ensuring CFSAN’s research portfolio was fully aligned with supporting regulatory action and program needs. The strategic plan for science and research encompasses over-arching strategic goals that direct CFSAN’s research enterprise toward being a leader in cutting-edge food safety research and anticipating scientific capacity needs in order to provide a more proactive approach to food safety regulation in line with FSMA priorities.
Strategic Goals Direct Regulatory Science
To ensure that the scientific research conducted at the center is aimed at addressing current critical regulatory needs, CFSAN senior leadership has set these six strategic goals that provide strategic priorities for CFSAN research over the next three years. These six goals do not encompass all of the important research activities at the center needed to support CFSAN’s broad regulatory mandate, such as developing methods, providing critical scientific support for enforcement actions, and conducting work needed to support regulatory decisions and guidance documents. These research activities will continue to function resource permitting. The six strategic goals are discussed in detail below.
1. Develop and evaluate intervention and preventive control strategies for microbial and chemical hazards in CFSAN-regulated products
Strategic Outcomes for Goal 1
- Have validated practices and processes for the safe production, harvesting, and processing of fresh fruits, vegetables, and ready-to-eat foods
- Identify sources of contamination and develop intervention strategies for measuring the effectiveness of production practices
- Have an improved understanding of survival, persistence, and growth of microbial pathogens in foods and food processing environments
- Have validated methods for detecting and identifying sources microbial pathogens in CFSAN regulated products
2. Develop and implement screening methods for use in field laboratories to improve the capacity for detection of chemical contaminants
Strategic Outcomes for Goal 2
- Have validated screening methods for multiple known chemical contaminants in FDA regulated products
- Have screening methods for new, emerging, and unidentified chemical contaminants of concern
- Develop methods and acquire data to establish action levels for high priority chemical contaminants
3. Advance scientific leadership in bioinformatics to further the agency’s regulatory and public health decision making
Strategic Outcomes for Goal 3
- Develop and implement genomic-based technologies to identify sources of foodborne contamination to support preventive control measures and early public health interventions
- Develop and implement data management strategies and bioinformatics analysis tools for systematic interpretation of complex data
- Establish practices for managing and sharing bioinformatics information among governments, industry, academia, and public health organizations
4. Integrate and apply modern toxicological approaches to support regulatory and public health decision making on chemical hazards in foods, dietary supplements, and cosmetics
Strategic Outcomes for Goal 4
- Establish processes that increase the predictability of chemical safety models for regulatory decision making
- Develop and implement a systematic approach to prioritize chemical compounds for toxicology testing based on predictive risk
- Evaluate and implement new, validated tools to assess the safety of chemicals
5. Advance diet and health research that contributes to the development of science-based policies and communication strategies
Strategic Outcomes for Goal 5
- Have evidence-based diet, health, and behavioral data to inform policies and communication strategies assisting consumers in achieving healthy dietary practices
- Apply nutrient analyses to support labeling for FDA regulated products
6. Engage our Centers of Excellence (COEs) and stakeholders to enhance FDA’s science and research resources to maximize public health benefit
Strategic Outcomes for Goal 6
- Use research conducted by CFSAN’s COEs to inform regulatory and public health decision making
- Use complementary research and resources of other Federal agencies (e.g., USDA, CDC) to support/sustain research that addresses CFSAN’s regulatory needs
As the regulatory environment for CFSAN-regulated products becomes increasingly complex, as well as new tools, technologies, and scientific needs continue to evolve, CFSAN’s scientific enterprise must build a foundation of collaborative research and scientific exchange to effectively support regulatory decision making. Leveraging combined efforts through strategic partners and stakeholders will allow CFSAN to more effectively allocate resources based on risk and public health priorities. For example, CFSAN scientists work with colleagues in academic institutions, federal and state food safety enterprises, foreign regulatory counterparts, and other scientific organizations to fill needs in toxicology, understand pathogen prevalence on the farm, and partner with federal and state partners on whole genome sequencing efforts. CFSAN will also continue to utilize its Centers of Excellence (COEs)  program as the prime route to enhance the center’s ability to reach a larger portion of the global food safety community. Collaboration with other regulatory and research organizations enhances the center’s ability fill critical data gaps to take regulatory action.
These strategic goals will be implemented over the next three years through an operational planning process aimed at outcome-driven research. This planning process is a bottom-up approach where both regulators and researchers sit down together in narrowly focused working groups to initially prioritize program needs and data gaps that fit within the strategic framework. The results needed to fill data gaps are designated as research outcomes, directing center research toward results-oriented and measurable outcomes that can be used to support regulatory action. These research outcomes are then prioritized by center management based on public health needs, regulatory requirements, and policy imperatives, in order to make optimal use of our resources. Regular reviews of progress toward meeting strategic goals and research outcomes are tracked through consistent reporting and research outcomes are designated and prioritized annually to ensure that the plan continues to meet current needs and that staff and resources are efficiently and effectively utilized. CFSAN also conducts its strategic research planning efforts alongside the Office of Foods and Veterinary Medicine to ensure enhanced cooperation among sister centers on cross-cutting research goals.
The strategic plan identifies regulatory science priorities that are essential to CFSAN’s continued success in carrying out its mission to protect and promote the nation’s public health with respect to CFSAN-regulated products. Effective implementation of this plan through consistent and sustained planning based in strategic goals and prioritized research outcomes will ensure that CFSAN’s scientific enterprise is meeting the regulatory challenges presented by an increasingly globalized marketplace for food and cosmetic products, as well as support a shift to a more prevention-oriented approach to food safety under new FSMA legislation.
 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.