Effective March 31, 2019, FDA will begin operational implementation of an agency reorganization. FDA’s reorganization reflects the agency’s commitment to modernizing its structure to advance its mission to protect and promote public health, and to meet the challenges of rapid innovation across the industries regulated by FDA. The FDA’s reorganization will realign several entities across the agency to promote strategic priorities, and will elevate the role of the centers, offices and field forces.
This organization chart reflects the new structure under which FDA will operate.
The FDA Office of Foods and Veterinary Medicine (OFVM), was created in 2009 to lead a functionally unified Foods and Veterinary Medicine (FVM) Program and enhance the Agency’s ability to meet today’s great challenges and opportunities in food and feed safety, veterinary medicine, nutrition, and other critical areas. To effectively meet the mission of protecting and promoting public and animal health and to implement provisions of the FDA Food Safety Modernization Act (FSMA), it is imperative that the FDA ensures a strong science and research infrastructure, that it clearly identifies its research needs, and that it collaborates with other public health and research agencies in the Federal government, State government agencies, academia, foreign regulatory counterparts, and private industry. The program’s goals and objectives are presented in the Strategic Plan for the Foods and Veterinary Medicine Program for Fiscal Years 2016-2025. The plan addresses the responsibilities of the OFVM, the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM) while including activities supported by the Office of Global Operations and Policy and the Office of Regulatory Affairs (GO/ORA). The plan illustrates the breadth and complexity of the program’s work and identifies objectives and strategies to achieve desired outcomes for a ten-year time period. It outlines four strategic program goals – Food Safety, Nutrition, Animal Health, and Organizational Excellence – with each encompassing its own key objectives and specific strategies for achieving those goals and objectives.
The FVM Science and Research Program arose from the defined precepts established for OFVM and it integrates the wide range of science-related and research-related responsibilities and activities of CFSAN and CVM. It also involves coordination with the FVM-related field activities of the ORA and utilizes the specialized capabilities of FDA’s National Center for Toxicological Research (NCTR).
Advancing regulatory science is one of the FDA’s core missions directed towards protecting human and animal health. As a science-based and evidence-based agency, the FDA must have access to the best scientific data and resources to support informed regulatory decision-making. In support of achieving this overarching aim, scientific expertise and research are two of the key foundations of the work conducted within the FVM Program. Human and animal food safety, animal health, and nutritional science are the primary drivers of research efforts within FVM. Agency activities such as setting preventive controls, investigating new pathogens and chemical hazards, and ensuring safe consumer products are supported by such research activities as the development of novel models and tools, the adoption of new technologies, and the application of innovative strategies to deal with emerging public health threats.
As a companion to the FVM Strategic Plan, the FVM Science and Research Key Initiatives were developed under the same overall goals as outlined in the strategic plan – Food Safety, Human Nutrition, Animal Health, and Organizational Excellence – to champion a strong science infrastructure with clearly defined research needs and priorities. It ensures broad collaboration with other public health and research agencies in the Federal and State government, academia, foreign regulatory counterparts, and private industry to effectively meet its mission of protecting and promoting public and animal health. In addition, it reiterates the Agency’s commitment to support the implementation of relevant provisions of FSMA through sound science and research.
An overview of the initiatives and objectives aligned to each OFVM Strategic Goal is as follows:
FVM Strategic Goal 1 – Food Safety
Key Initiative: Protect America’s Consumers and Animals From Foreseeable Hazards Across the Global Farm-to-Table Continuum
- Reduce the risk of chemical, allergen, and radiological exposures in food and feed products that pose public health or regulatory concerns
- Reduce the risk of microbial hazards in food and feed products
- Enhance food defense throughout the supply chain by developing methods and survey strategies to reduce the risk of intentional (malicious) introduction of hazardous chemicals, microbial agents, or toxins
- Enhance food defense by developing chemical and molecular methods for preventing the introduction of mislabeled, counterfeit, or economically adulterated products into the marketplace
- Provide regulatory tools and resources necessary to ensure safety of genetically-modified organisms (GMOs)
- Develop preventive control strategies for hazards in FDA regulated products
- Enhance detection and response to foodborne illness outbreaks and other food/feed incidents
- Strengthen or create partnerships, with other governmental agencies and domestic/ foreign entities, to enhance the effectiveness and efficiency of food/feed safety efforts
- Enhance the safety of food/feed additives and generally recognized as safe (GRAS) substances
FVM Strategic Goal 2–Nutrition
Key Initiative: Support Healthy and Safe Choices in Food and Other Consumer Products
- Provide and support accurate nutrition information and evidence-based recommendations
- Assess emerging nutrition science and changes in the composition of foods in the marketplace
- Provide a broad science base to facilitate new products and product formulations to promote a healthier food supply
- Improve data-driven surveillance, detection, and responses to human illnesses associated with dietary supplements, including the development of screening methods
- Provide regulatory tools and resources necessary to ensure safety of cosmetics
FVM Strategic Goal 3 – Animal Health
Key Initiative: Protect Animal and Public Health By Helping to Ensure The Safety and Effectiveness of Animal Health Products
- Ensure safe and effective animal drug products, and reduce the risk of harm from unsafe use of marketed drugs
- Reduce the risk and availability of substandard/illegally marketed animal drugs
- Promote the judicious use of medically important antimicrobials in food animals to minimize the development of resistance
- Strengthen detection, surveillance, and responses to incidents related to FDA-regulated animal health products
- Ensure the safety of food products derived from genetically-engineered animals, and provide for the detection of these products in the marketplace
FVM Strategic Goal 4 – Organizational Excellence
Key Initiative: Enhance OFVM’s Science and Research Resources and Activities for Optimal Public Health Benefits
- Achieve risk-based resource allocation utilizing risk analysis and tracking of impact metrics
- Optimize FVM scientific and organizational capacity to enhance detection, prevention, and response strategies to identified hazards
- Maintain and strengthen mission-critical science capabilities through workforce development, technological modernization, and innovation
- Enhance stakeholder engagement and leverage external resources
- Develop data sharing capacity and reporting coordination with other governmental and non-governmental entities
- Facilitate harmonization with internal and external laboratory certification guidelines/standards Establish a methods portal to allow access, by external entities, to current regulatory methods being used within the FVM Program, including state validated methods
The Strategic Plan for the Foods and Veterinary Medicine Program and the FVM Science key initiatives form an integrated framework for the development of Center strategic operational goals. A crosswalk of the FVM-Center alignment is depicted in the table below.
|CVM office of research operational goals and outcomes||FVM program goal and outcomes||CFSAN strategic research goals|
|Establish and gain high rates of compliance with science-based preventative control standards across the global farm-to-table continuum.||FOOD SAFETY Protect America’s consumers and animals from foreseeable hazards
OUTCOME Reduce the incidence of illness and deaths attributable to preventable contamination of FDA-regulated food and food producers
SCIENCE KEY INITIATIVE: PROTECT AMERICA’S CONSUMERS AND ANIMALS FROM FORESEEABLE HAZARDS ACROSS THE GLOBAL FARM-TO-TABLE CONTINUUM .
|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.
Integrate and apply modern toxicological approaches to support regulatory and public health decision making on chemical hazards in foods, dietary supplements, and cosmetics. Engage the Centers of Excellence (COEs) and stakeholders to enhance FDA’s science and research resources to maximize public health benefit.
|Monitor and assess emerging nutrition science as well as changes in the composition of foods in the marketplace in relation to the nutritional and health status of Americans.
Improve access to safe and effective animal drug products.
|NUTRITION Foster an environment to promote healthy and safe food choices
OUTCOME Reduce risk factors for and the incidence of nutrition-related chronic disease
SCIENCE KEY INITIATIVE: SUPPORT HEALTHY AND SAFE CHOICES IN FOOD AND OTHER CONSUMER PRODUCTS
|Advance diet and health research that contributes to the development of science-based policies and communication strategies.|
|Strengthen detection and surveillance of problems with FDA-regulated animal food and feed, animal-derived food, and animal health products. Reduce risks in the manufacturing, production, and distribution of FDA regulated animal health products.||ANIMAL HEALTH Protect human and animal health by enhancing the safety and effectiveness of animal health products
OUTCOME Reduce human and animal illness and death from FDA-regulated animal health products
KEY INITIATIVE: PROTECT ANIMAL AND PUBLIC HEALTH BY HELPING TO ENSURE THE SAFETY AND EFFECTIVENESS OF ANIMAL HEALTH PRODUCTS
|Increase collaboration, training, and information sharing with the scientific community, industry, and other regulatory bodies. Foster evidence-based decision making through collaboration, training, and information sharing with the scientific community, industry, and other regulatory bodies.
Develop and maintain effective internal communication, horizontally and vertically, within CVM, FVM, FDA, and with other government departments. Achieve optimal risk-informed resource allocation. Optimize the scientific expertise and organizational capacity Attract, retain, and optimally deploy the skilled workforce required to lead, manage, and execute the FVM Program’s public health mission.
|ORGANIZATIONAL EXCELLENCE Continuously improve leadership, management, staffing, and organizational capacity of the FVM program to protect public health
OUTCOME Enable the FVM Program to optimize public health gains by making the best use of available resources
SCIENCE KEY INITIATIVE: ENHANCE OFVM’S SCIENCE AND RESEARCH RESOURCES AND ACTIVITIES FOR OPTIMAL PUBLIC HEALTH BENEFITS
|Advance scientific leadership in bioinformatics to further the agency’s regulatory and public health decision making.|
CFSAN Research Strategic Plan
Overall management within the FVM Science and Research Program encompass resource planning, reporting and tracking and impact assessment. Research objectives and research projects are established to fill knowledge gaps needed to meet Center and FVM operational goals. Risk-informed prioritization processes play a key role in annual resource planning. (see section below for greater detail on the prioritization process). Research progress and post-research impact are tracked against proposed milestones and barrier to success throughout the life of the project in the former instance, and against regulatory and public health metrics in the latter instance.
Download the CFSAN Research Strategic Plan.