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  1. Foods and Veterinary Medicine Science and Research

About the FVM Science and Research Steering Committee (SRSC)

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.

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The Strategic Plan for the Foods and Veterinary Medicine Program for Fiscal Years 2016-2025 identifies key goals and objectives to advance food safety, nutrition and animal health. In working to meet the goals of the FVM Program, the Science and Research Steering Committee (SRSC) was created and includes science and research leaders from the operating units of the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Regulatory Affairs (ORA), the National Center for Toxicological Research (NCTR), as well as the Office of the Chief Scientist and the Office of International Programs. Members play a dual role as representatives of their organizations and as leaders in this critical FVM initiative whose success depends on close collaboration and addressing issues from a cross-cutting perspective.

The SRSC is chaired by the Office of Foods and Veterinary Medicine’s (OFVM) Chief Science Officer and Research Director.

The SRSC is the chartered operational arm of the FVM Executive Council for science and research activities. All aspects of FVM research – including identification of research objectives, establishment of priorities in alignment with the FVM Strategic Plan, and prevention of unnecessary duplication within the FVM research enterprise – are coordinated through the SRSC. As such, the SRSC’s primary role is to lead, coordinate, and unify natural science research and methods development strategies across FVM. Key components of the SRSC mission include:

  • Developing and implementing an FVM Science and Research Strategic Plan to strengthen and maintain core science and research capabilities
  • Developing and implementing a common framework and process for prioritizing FVM research
  • Developing and implementing a unified analytical methods development and validation program that is aligned with FVM priorities
  • Developing and communicating improved processes for technology transfer of research and methods to FVM program offices
  • Aligning the roles and responsibilities of each laboratory operating unit across FVM
  • Optimizing use of laboratory staff and resources across FVM

All FVM research projects support more generally defined research objectives (ROs). Though largely discipline-specific, ROs include the evaluation of innovative technologies for future regulatory applications; method development, validation and implementation of new analytical methods for field laboratories; horizon scanning and knowledge gap analyses; and, basic research efforts to enhance surveillance programs and outbreak investigations.

Current ROs include: 

Research Objectives (ROs)

Microbiology & Chemistry Toxicology Nanotechnology
Multi-laboratory Validation Microphysiological systems (Organs-on-chips) established and evaluated for regulatory applications Bio-sensing using nanoparticles or nanoparticles adapted devices
Develop methods to replace or modify existing FDA regulatory methods. Use of alternative animal models for toxicology testing Food packaging – migration/exposure studies
Develop new methods to address regulatory analysis gaps or new regulatory requirements Establish and evaluate in silico systems for pharmacokinetic/toxicokinetic and pharmacodynamics/toxicodynamic modeling Nanoparticle toxicology or pharmacology
Develop new emergency screening methods In vivo and in vitro testing of chemicals of concern Skin penetration/dermal exposure from cosmetics
Develop portable devices for rapid, forward-deployed methods   Method development for assessing particle characteristic or behavior
Develop portable devices for rapid, forward-deployed screening   Detection or characterization of nanoparticles in biological systems or FDA-regulated projects
Develop multianalyte non-targeted and targeted methods    
Develop high-throughput or highly parallel sample preparation methods

 

 
Develop methods or approaches to support and implement preventative controls    
Develop methods to address economic adulteration    
Evaluation of new technology instrumentation

 

 

Oversight of the SRSC activities is vested in the OFVM Science and Research Team (SRT) led by the Chief Science Officer and Research Director. The SRT’s overarching responsibilities are to provide oversight, to give strategic direction, and to monitor all activities associated with the FVM Science and Research Enterprise. Intrinsic and routine responsibilities for the SRT include using research tracking tools to assess/evaluate information on laboratory and research programs that are provided by Center and ORA leadership. Review of this data is routinely used for assessment of overall funding priorities, for elimination of duplicative research, and for support of key investment decisions regarding the purchase of capital equipment and innovative/cutting edge technologies to maximize the investment opportunities.

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The Foods and Veterinary Medicine (FVM) Research Prioritization Process

The FVM Science and Research Prioritization Framework is a simultaneous, two-track process – an “operational year” and a “planning year” – with each track aligning with the Federal fiscal year (FY) calendar (01October – 30September).

The “operational year” involves the execution of the current fiscal year’s (FY) research plan that had been finalized and adopted at the end of the previous FY. It encompasses all aspects for the managerial and collaborative oversight of FVM Science and Research activities. Specifically, it includes the development of a FY research roadmap (a study design and implementation plan for each research objective (RO); a periodic (tri-annual) evaluation of all cross-cutting research projects; a mid-year review to examine trends, newly-realized knowledge gaps; and, additional needs for method validation and implementation for the next FY.

The “planning year” is a horizon scanning phase for the next FY (FY+1). It encompasses gap analysis and work/spend planning activities to evaluate future research needs; resource availability and priorities based on aligned to FVM and Center Strategic objectives and priorities.

The complete text that outlines the annual prioritization and evaluation process and timeline can be found here.

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FVM Research Activities

I. The “Biennial Report to Congress on the Food Safety and Food Defense Research Plan Pursuant to Section 110 (g) of the Food Safety Modernization Act (FSMA) Section 110(g)”

FSMA directed the building of a new food safety system based on the public principle of comprehensive prevention, an enhanced focus on risk-based resource allocation, and partnership across the public and private sectors to minimize hazards from farm to table. It was recognized that integral to the success of FSMA is the need for a cooperative and collaborative Federal research effort as it is essential for supporting prevention standards, understanding foodborne hazards, and developing intervention strategies to protect the U.S. food supply and consumers. Such a foundation ensures that public health decision making and policy making that ultimately improves the safety and security of the food supply are based on sound basic and regulatory science.

As mandate in 2011 when the FSMA became law:

…The Secretary [of Health and Human Services], the Secretary of Agriculture and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan with may include studying the long-term health effects of foodborne illness. Such [a] biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.

This report on the Federal food safety research portfolio and plan of the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) was developed as an interagency collaborative effort to highlight food safety research conducted or supported by individual agencies as well as collaborations among Federal agencies. These include FDA and the Centers for Disease Control and Prevention within the HHS; and the Agricultural Research Service, Economic Research Service, Food Safety and Inspection Service and the National Institute of Food and Agriculture within the USDA.

The complete text of the first biennial report to Congress in 2015 [Link] includes the federal inventory of active research projects funded during the fiscal years 2011 and 2012 along with a summary of collaborative interagency strategic planning for future years. The report is divided into eight general categories and reflects the diverse nature of the food safety and security concerns and the resulting portfolio of projects:

  • Prevention, intervention and control of foodborne hazards;
  • Detection of microbial, chemical and radiological hazards in food, feed, and dietary supplements;
  • Molecular characterization of foodborne pathogens as it relates to research on the mechanism of disease and/or epidemiology of foodborne disease;
  • Antimicrobial resistance/susceptibility of foodborne microorganisms;
  • Designed epidemiologic studies of foodborne illness/associated organisms;
  • Risk assessment, modeling, management, and communication;
  • Safety assessments of foodborne hazards, including toxicological studies; and,
  • Economic analysis

An overview of the distribution of research among those Federal agencies principally tasked with food safety and security can be found in the table below. It reflects the collaborative and integrative approach these agencies have undertaken to more efficiently address the issues threatening the food supply and public health.

FSMA 110(g) General Categories

Organi-zation Risk assessment modeling manage-ment and communi-cation Prevention, intervention and control of foodborne hazards Detection of microbial, chemical and radiological hazards in food, feed and dietary supplements Antibiotic/ antimicrobial resistance/ susceptibility of foodborne microbes Designated epidemio-
logic studies of foodborne illness/ associated organisms
Economic analysis Molecular character-ization of foodborne pathogens as it relates to research on the mechanism of disease and/ or epidemiology of foodborne disease Safety assessments of foodborne hazards including toxicological studies Total Research Effort
FDA 22 (6%) 10 (12%) 198 (58%) 13 (3%) 6 (3%) 1 (<> 24 (7%) 10 (12%) 344
CDC 3 (50%) 2 (33%) 1 (17%) 0 0 0 0 0 6
USDA 32 (10%) 129 (41%) 57 (18%) 17 (5%) 9 (3%) 24 (8%) 40 (13%) 4 (1%) 312

The current distribution of FDA’s food safety research (FY17) is reflected in the following table:

FSMA 110(g) General Categories

Number of Projects Addressing Priorities, by FDA Center, Per Science and Research Team Tracking and Reporting, All Projects since October 2015

Organi-zation Risk assessment modeling manage-ment and communi-cation Prevention, intervention and control of foodborne hazards Detection of microbial, chemical and radiological hazards in food, feed and dietary supplements Antibiotic/ antimicrobial resistance/ susceptibility of foodborne microbes Designated epidemio-
logic studies of foodborne illness/ associated organisms
Economic analysis Molecular character-ization of foodborne pathogens as it relates to research on the mechanism of disease and/ or epidemiology of foodborne disease Safety assessments of foodborne hazards including toxicological studies Total Research Effort
FDA 16 (4%) 60 (15%) 233 (58%) 21 (5%) 5 (1.2%) 1 (<> 51 (12.6%) 16 (4%) 403
CFSAN 14 50 142 0 5 1 38 16 266
CVM 2 1 28 21 0 0 7 0 59
ORA 0 19 63 0 0 0 6 0 78

II. FVM Research Reporting and Tracking: The Component Automated Reporting and Tracking System (CARTS)

The FVM Component Automated Research Tracking System, CARTS is an internal FDA application to manage research activities within the FVM Science and Research Program including both intramural and extramural research. It is a web-based tool for planning, tracking, reporting, and archiving important details and progress associated with research projects/activities being conducted within or in cooperation with OFVM. Additionally, the program includes several simple ways for searching both current and past research efforts; this allows for accessing the data quickly and in a consistent manner.

For FY18, project alignment with FVM science and research key initiatives is illustrated below.

At the FVM level, research is tracked and assessed using the following strategic elements:

  1. FSMA Section 108(a): National Agriculture and Food Defense Strategy Report Categories
  2. FSMA Section 110(g): Biennial Food Safety and Food Defense Research Report Categories
  3. FVM Risk-informed Priorities
  4. FVM Microbiology Risk-informed Priorities
  5. Partnerships and Collaborations
  6. Research Coordination Group and Discipline Area
  7. Tactical OFVM Science and Research Objective

Operational tracking elements are further defined by the CFSAN, CVM and ORA.

An overview of the FVM research activities, the complementary of research and areas of emphasis (as of the end of FY17) is illustrated in the following graphics:

Project Alignment with FVM Science and Research Key Initiatives are in the areas of Food Safety, Animal Health, Human Health and Nutrition and Organizational Excellence. Of percentage of total research effort by Center/Office, most CFSAN’s research is in the area of Food Safety, followed by Human Health and Nutrition, Organization Excellence and then Animal Health. CVM’s primary area of focus is in Animal Health, followed by Food Safety, Organizational Excellence and Human Health and Nutrition. ORA’s research is primarily in the area of Food Safety, followed by Human Health and Nutrition, Organizational Excellence and Animal Health.

Project Alignment with FVM Science and Research Key Initiatives are in the areas of Food Safety, Animal Health, Human Health and Nutrition and Organizational Excellence. Of percentage of total research effort by Center/Office, most CFSAN’s research is in the area of Food Safety, followed by Human Health and Nutrition, Organization Excellence and then Animal Health. CVM’s primary area of focus is in Animal Health, followed by Food Safety, Organizational Excellence and Human Health and Nutrition. ORA’s research is primarily in the area of Food Safety, followed by Human Health and Nutrition, Organizational Excellence and Animal Health.

According to research project data, the majority of FVM research is conducted by CFSAN (63%), followed by ORA (19%) and closely by CVM (18%). Of those figures, 169 of CFSAN’s projects are center specific, while 130 are cross-cutting; 65 of CVM’s projects are center specific, while 23 are cross-cutting; and 36 of ORA’s projects are center specific, while 53 are cross-cutting

According to research project data, the majority of FVM research is conducted by CFSAN (63%), followed by ORA (19%) and closely by CVM (18%). Of those figures, 169 of CFSAN’s projects are center specific, while 130 are cross-cutting; 65 of CVM’s projects are center specific, while 23 are cross-cutting; and 36 of ORA’s projects are center specific, while 53 are cross-cutting.

The majority of CFSAN activities are related to other food safety research. Of the method validation activity conducted by CFSAN, activity can be categorized in to other center activities, food safety, nutrition, dietary supplements, cosmetics, color certification and food defense. The Majority of CVM activities are related to other food Safety Research. Of the method validation activity conducted by CVM, activity can be categorized in to other center activities, animal drugs, antimicrobial resistance and animal food/feed safety.</p>
  <p>Project Alignment with FVM Science and Research Key Initiatives are in the areas of Food Safety, Animal Health, Human Health and Nutrition and Organizational Excellence. Of percentage of total research effort by Center/Office, most CFSAN’s research is in the area of Food Safety, followed by Human Health and Nutrition, Organization Excellence and then Animal Health. CVM’s primary area of focus is in Animal Health, followed by Food Safety, Organizational Excellence and Human Health and Nutrition. ORA’s research is primarily in the area of Food Safety, followed by Human Health and Nutrition, Organizational Excellence and Animal Health.

The majority of CFSAN activities are related to other food safety research. Of the method validation activity conducted by CFSAN, activity can be categorized in to other center activities, food safety, nutrition, dietary supplements, cosmetics, color certification and food defense. The Majority of CVM activities are related to other food Safety Research. Of the method validation activity conducted by CVM, activity can be categorized in to other center activities, animal drugs, antimicrobial resistance and animal food/feed safety.

Project Alignment with FVM Science and Research Key Initiatives are in the areas of Food Safety, Animal Health, Human Health and Nutrition and Organizational Excellence. Of percentage of total research effort by Center/Office, most CFSAN’s research is in the area of Food Safety, followed by Human Health and Nutrition, Organization Excellence and then Animal Health. CVM’s primary area of focus is in Animal Health, followed by Food Safety, Organizational Excellence and Human Health and Nutrition. ORA’s research is primarily in the area of Food Safety, followed by Human Health and Nutrition, Organizational Excellence and Animal Health.

III. Partnerships, FSMA-Related Reports And Stakeholder Outreach And Communication

About CFSAN and CVM Research

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  1. MEMORANDA OF UNDERSTANDING
    1. Memorandum of Understanding between the Canadian Food Inspection Agency and the United States Food and Drug Administration concerning the sharing of Information and Facilitation of Collaborative Research Products
    2. Memorandum of Understanding between the U.S. Department of Health and Human Services, the Food and Drug Administration Office of Foods and Veterinary Medicine and the Independent Laboratories Institute
  2. Report to Congress on the National Agriculture and Food Defense Strategy (NAFDS)
  3. FSMA Lab Accreditation Rule
  4. Biennial Reports to Congress on the Food Emergency Response Network
  5. Charter for the Interagency Collaboration on Genomics for Food and Feed Safety (Gen-FS)
  6. The Food Emergency Response Network (FERN)
  7. The Veterinary Laboratory Investigation and Response Network (Vet-LIRN)