Food

Research Strategic Plan

Center for Food Safety and Applied Nutrition

Science and Research Strategic Plan 

2015-2018

Introduction

The Center for Food Safety and Applied Nutrition (CFSAN) is a science-based regulatory organization within the Food and Drug Administration 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 lines1. 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.  Recently, the finalized rule for Preventive Controls for Human Food was released, allowing the center to utilize new enforcement tools authorized by FSMA.  Grounded in the latest science, these authorities and the six other rules required by the landmark FSMA legislation 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 cosmetics safety, food defense, and applied nutrition.  The strategic plan accounts for our regulatory responsibilities and trends in the food and cosmetics sectors, as well as incorporating new responsibilities for the agency resulting from 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 regulatory decisions have a sound science footing and that the center is using the best methods and tools available to advance food and cosmetics safety.  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 set out in the FDA Foods and Veterinary Medicine (OFVM) Program Strategic Plan

Vision Statement

Support CFSAN’s mission to protect and promote public health by addressing critical knowledge gaps through research needed to support regulatory decision making.

Strategic Goals Development

Every three years, CFSAN evaluates and updates our strategic plan by identifying strategic goals that are 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 supports regulatory action and program needs.  The current strategic goals target specific areas in food safety research that support a forward-looking approach to food safety regulation in line with FSMA priorities.

Strategic Goals Direct Regulatory Science

The strategic plan for 2015-2018 identifies six strategicgoals that would have, in the near term, the greatest impact for modernizing the nation's food safety system and protecting public health.  These are:

  1. Develop and evaluate intervention and preventive control strategies for microbial and chemical  hazards in CFSAN-regulated products
  2. Develop and implement screening methods for use in field laboratories to improve the capacity for detection of chemical contaminants   
  3. Advance scientific leadership in bioinformatics to further the agency’s regulatory and public health decision making
  4. Integrate and apply modern toxicological approaches to support regulatory and public health decision making on chemical hazards in foods, dietary supplements, and cosmetics
  5. Advance diet and health research that contributes to the development of science-based policies and communication strategies
  6. 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 Outcomes Fulfill Strategic Goals

In order to achieve the strategic goals set by the center, the plan identifies strategic outcomes that must be accomplished to fully meet the strategic goal.  The strategic outcomes for each of the six strategic goals are shown 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 of microbial pathogens in CFSAN regulated products
  1. 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
  1. 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 in order 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
  1. 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
  1. 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
  1. 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

The strategic goals and outcomes establish priorities for CFSAN research for the next three years.  Consequently, they do not encompass all of the research needed to sustain CFSAN’s broad regulatory mandate for enforcement actions, rule-making, and guidance documents.  Research essential for supporting these activities will continue within the center.  CFSAN also relies on collaborative research with federal, state, and academic partners to expand its science base for regulatory decision making, as well as using its COEs as the prime means of leveraging resources to more effectively fill critical data gaps. 

Implementation

This strategic plan will be implemented over the next three years through an operational planning process aimed at outcome-driven research.  This planning process uses a bottom-up approach where regulators and researchers convene 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 outcomes are then prioritized by center management based on public health criteria, regulatory requirements, and policy imperatives, in order to make optimal use of our resources.  To ensure that the plan continues to meet current strategic goals, research outcomes are designated and prioritized annually and progress toward achieving research outcomes is tracked quarterly.  CFSAN also coordinates its strategic research planning with the OFVM to ensure enhanced cooperation among sister centers on cross-cutting research goals.

Conclusion

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 of strategic goals and prioritized research outcomes supporting those goals will ensure that CFSAN’s scientific enterprise is meeting the regulatory challenges presented by an increasingly globalized marketplace for food and cosmetic products.  It will also promote the shift to a more prevention-oriented approach to food safety under new FSMA legislation.


1) http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/WhatWeDo/default.htm

2) 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.

Page Last Updated: 10/19/2015
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