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Text Version: Subcommittee Final Report on Research at the Center for Food Safety and Applied Nutrition (CFSAN) (Applebaum)

Text version of slide presentation

Slide 1

Center for Food Safety and Applied Nutrition: Research, Support Programs and Alignment with Regulatory Responsibilities

Final Report to the FDA Science Board

August 16th, 2010

 

Slide 2

Agenda 

  1. Overview
    • CFSAN
    • Situation
    • Charge
    • CFSAN Research Review Subcommittee (CRRS)
    • Timeline/Process
  2. Findings and Observations
    • SWOT
    • Consumer Research
  3. Recommendations
  4. Charge and Review Objectives
    • Response from the CRRS (focal points)
  5. Wrap-Up
    • Reality and Challenges
    • Commentary

Slide 3

CFSAN: Mission Statement

Protect and promote the public’s health by ensuring the Nation’s:
  • Food supply is safe, sanitary, wholesome and honestly labeled
  • Cosmetic products are safe and properly labeled
In relation to “what FDA does”:
  • Protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. 
  • Advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable;andhelping the public get the accurate, science-based information they need to usemedicines and foods to improve their health.

Slide 4
CFSAN: Role and Responsibilities 

Science-based regulatory organization
  • Food and cosmetic safety mission of FDA
Operates on a national and global stage
  • Complex, expanding supply chains
  • Safety, nutrition and labeling accuracy
  • International standard setting (e.g. Codex and Quads)
Build, sustain vigorous, high-quality intramural and extramural programs
  • Laboratory and Non-laboratory Research
  • Regulatory policy
  • Compliance and enforcement program, statutory responsibilities

Slide 5
Situation-Now and Future

  • Continuously changing and increasing responsibilities
  • Science and tools that are more advanced and complex
  • Expanding range of foods and cosmetics (and ingredients)
  • Increasing imports
  • More complex regulatory and risk environment

 

Expectation—Now and Future
  • Mitigate today’s problems
  • Anticipate and act on tomorrow’s crises

Slide 6
CFSAN Staffing vs. Growing Responsibilities
 

Growing Responsibilities

2002
  • Farm Bill
  • FDAMA-Food Contact Substance
  • BT Act
  • Consumer Health for Better Nutrition
2004

  • “Calories Count”
  • Enhanced Safeguards Against BSE
  • Food Allergen Labeling/ Consumer ProtectionAct
2005
  • Egg Labeling-Proposed Rule
  • Egg Shell Safety-Proposed Rule
  • Produce Safety
  • Sanitary Food Transportation Act
2006
  • Food cGMP Modernization
  • Listeria monocytogenes
  • New Dietary Ingredients
  • Dietary Supplement and Nonprescription Drug Consumer Protection Acts
2007
  • Pandemic Flu
  • Mandatory AER
  • FDAAA – Food Registry                              

 2010

  • Food Safety Enhancement Act

Slide 7

A few facts:

  • $417 billion worth of domestic food
  • $49 billion worth of imported foods 
  • $60 billion worth of cosmetics sold across state lines
  • Over 377,000 registered food facilities
    • 154M domestic 
    • 233M foreign

Economic importance of the US food industry is enormous

Slide 8 and 9

Charge to CRRS

In consideration of the broad categories of scientific expertise and technologies to CFSAN needs (regulatory functions and decision making)

  1. Identify gaps in scientific expertise and technological capability in which CFSAN should increase efforts to ensure that it can address current and future demands
  2. Review and recommend research areas where CFSAN might reduce, maintain or expand its current levels of research effort
  3. Identify opportunities to leverage scientific programs through partnerships
  4. Determine if CFSAN is doing what is needed to recruit, develop, and retain the professional expertise needed to address current and future challenges
  5. Assess and recommend management and review practices for setting priorities to guide the direction of resources to the highest priority activities
  6. Identify the most important future challenges facing the Center scientific research enterprise as well as the major institutional and systemic barriers to addressing them

Slide 10

 

Name
Title
Expertise
Affiliate
Rhona Applebaum
VP, Chief Scientific & Regulatory Officer
Food Microbiology, Food Safety, Nutrition and Regulatory Science
The Coca-Cola Company
John Floros
Professor and Head, Dept of Food Science
Food Science & Technology
Pennsylvania State University
Christine Bruhn
Director, Center for Consumer Research
Consumer Food Marketing Specialist, Consumer Behavior / Food Safety, Risk Communication
University of California-Davis
Fergus Clydesdale
University Distinguished Professor and Director of Food Science Policy Alliance
Food Science, Nutrition Science, Regulation
University of Massachusetts – Amherst
Johanna Dwyer
Senior Nutrition Scientist
Clinical Nutrition Science and Food Composition
Tufts University / National Institutes of Health
John Sofos
University Distinguished Professor, Center for Meat Safety & Quality
Food Microbiology, Food Safety, Animal Science
Colorado State University
Tom Trautman
Fellow, Toxicology & Regulatory Affairs
Toxicology, Food Safety, Regulatory Science
General Mills
Larry Sasich
Stepped down
 
Consumer Representative
LECOM School of Pharmacy
Sam Godefroy
Stepped down
Director General of the Food Directorate
Food Analytical Methods, Risk Assessment, Food Standards
Health Canada

Slide 11 and 12

Timeline/Process

August – November, 2009
  • CFSAN Research Review Requested
  • Subcommittee identified/vetted
  • Series of conference calls to review charge/materials
  • Conference calls with CFSAN representatives
    • CFSAN Strategic Plan
December
  • Identified date for 2-day meeting with CFSAN to review research
January 14-15, 2010
  • “Fact Finding Mission” at CFSAN
  • Toured Office of Regulatory Science (ORS) and Office of Applied Research and Safety Assessment (OARSA) Laboratories
    • Twelve different research areas/labs
  • Poster session (40 studies/projects)
  • Briefed on Office of Cosmetics and Colors
  • Briefed on CFSAN Research Strategic Plan
  • Q&A with CFSAN Research Office and Division Directors

Slide 13

Tour of Office of Regulatory Science (ORS) Laboratories

Dr. John Callahan-Spectroscopy and Mass Spectrometry Branch
Dr. Timothy Begley-Method Development Branch
Dr. Thomas Hammack-Microbial Methods Development Branch
Dr. Eric Brown-Molecular Methods and Subtyping Branch
Dr. Alexander Krynitsky-Bioanalytical Methods Branch
Dr. Stephen Capar-Chemical Contaminants Branch

Tour of Office of Applied Research and Safety Assessment (OARSA), MOD-1 Laurel, MD

Dr. Chris Elkins-Molecular Genetics Branch
Dr. Gene LeClerc-Molecular Virology Team
Dr. Kristina Williams-Immunobiology Branch
Dr. Atin Datta-Virulence Mechanisms Branch
Dr. Robert Sprando-Developmental, Reproductive, Toxicology and Immunotoxicology Branch
Dr. Paddy Wiesenfeld-Neurotoxicology & In Vitro Toxicology Branch
 

Slide 14

Timeline/Process
January – February, 2010
  • Data Review
  • Interim Report to FDA Science Board–February 22, 2010

March – August, 2010

  • Data Review
  • Report Writing
  • Presentation–August 16, 2010

Slide 15

Initial Findings

Research is Essential to the Mission of CFSAN
Laboratory and Non-Laboratory Research

  • Basic
  • Applied/Practical

More Clarity on Research Prioritization
Administrative / Lab Support
More Connectivity / Interaction / Alignment / Visibility

  • FDA Leadership Offices/Centers
  • CFSAN Centers of Excellence (COEs)
  • Within CFSAN itself
  • Other agencies, stakeholders  – national and international

Resources
Need for a SWOT

Slide 16

From the CRRS perspective, and in light of the Strategic Plan, wanted to ascertain the overall strategic position of CFSAN and its environment. 

Recommend a repeat using a good cross section of staff and external people

Slide 17

Slides 18-21 contain the same contents

SWOT of CFSAN Science & Research

Strength, Weakness, Opportunities, Threats

Slide 18 Strengths

People
  • Scientific leadership
  • Excellent scientific expertise
  • Strong core group of senior scientists
Facilities
  • Excellent facilities
  • Modern equipment
  • Regional centers that address specific topics
Programs
  • Large organization with expertise devoted to specific problem areas
  • Addressing the mission across a wide variety of food commodities and issue areas.
  • Large array of topics covered with strong expertise
  • Research is abreast of the science and in some cases, ahead of the science as it relates to future food safety risks
  • The “Quad Approach’” used by the Office of Cosmetics  to keep abreast of emerging issues (US, Canada, Japan and EU)
Slide 19 Weaknesses
People
  • Lack of scientists with specific food science competencies and experience
  • Limited  administrative staff so senior scientists needed for routine tasks
  • Poor training of current support staff uses senior scientists for routine tasks
  • Insular & limited relations with COE’s
  • Limited interaction with external scientists not part of FDA
  • Insufficient communication opportunities for cross & within-function disciplines
  • Management leadership – insufficient  people with necessary experience & vision
Programs (General)
  • Mission creep, lack of focus & unclear mechanism for identifying priority areas
  • Overlap in research between centers & inadequate budget
  • Few examples of basic research being tied to FDA regulations and policing
  • Delayed reporting of agency findings in the scientific literature
Programs (Nutrition & Health)
  • Lack of research on nutrition, obesity and lifestyles with consumers
Programs (Food Science)
  • Food processing and packaging research
  • Food Chemistry
Programs (Social Science & Risk Communication)
  • Social science research is not as thoroughly integrated with bench science
  • Delayed response to ongoing & emerging issues in social science & behavior research
  • Evaluative research on impact of agency communications, regulations and mission not completed in a timely fashion
  • Evaluating agency action effectiveness is given only cursory attention
  • Little evidence of public outreach and education
     
Slide 20 Opportunities
People
  • Current economic challenges have resulted in availability of highly qualified scientists
Programs
  • Become the premier scientific food regulatory agency through top research programs in food safety, food science & nutrition
  • Tie research to real-time regulatory activities to make a case to Congress & consumers
Communications
  • Promote programs/research benefits to increase visibility & obtain greater funding
  • Share information among bench scientists & social scientists within the agency
  • Increase communication effectiveness by working closely with social scientists implementing the FDA Strategic Plan for Risk Communication
  • Hold periodic planning sessions/table top exercises with agency scientists & stakeholders (e.g, academic, industry, & consumer representatives) to assess/ mitigate/rehearse current & emerging issues
  • Address how the agency can most effectively complete its mission
  • Develop and implement a plan to evaluate research effectiveness
  • Lack of nutrition research could provide opportunities to build capacity of one or more COEs, use intramural/extramural research programs to collaborate with research groups nationally & internationally, in government, academia, etc.

Slide 21 Threats

Funding
  • Funding threat if agency does not effectively communicate plan, actions, & impact.
  • Retention of scientific talent and expertise
Mission
  • Research is deemed irrelevant for FDA
  • Food is diminished compared to drugs in the FDA mission
  • Reputation and Influence
  • Other organizations recognized as primary food safety & nutrition science  resource
  • Loss of credibility with the public and Congress
  • Loss of credibility and influence with international trading
  • Food policy & regulation not based upon best available science
  • FDA is not a food NIH & there are dangers if that notion is perpetuated
  • Proposed changes to funding mechanism and charter of NACMCF threaten to undermine this prestigious scientific advisory committee
Working relationship
  • Loss of relationships/networks/collaborations if skills not transferred
Slide 22

Findings and Observations

Staffing:

  • Dedicated, committed to CFSAN’s mission, quality of science
  • Insufficient support (administrative and technical positions)
  • Increase effort for people development,/succession planning

Research: 

  • Focus on both laboratory and non-laboratory research is critical
  • Better integration and need for alignment
  • More attention to applied research:  food science, food processing, food technology and nutritional science having regulatory implications 

Consumer Research and Communication: 

  • Risk, regulatory science and consumer communication are critical
  • Including evaluation of the impact on consumer understanding and behavior
  • Must become an integral component of CFSAN regulatory action

Slide 23-25

Assessment of Consumer Research

Why:
  • Importance of consumer research in general, and specifically related to regulatory decision-making and enforcement
  • Non-laboratory research is identified as part of  CFSAN’s research program and FDA’s Mission
  • Was not specifically addressed/reported on during the site visit
  • It was the consensus of the CRRS that consumer research/education must be integral to CFSAN’s Science and Research Program
Observations:
  • Has an on-going plan to investigate consumer attitudes, knowledge and behavior in the area of food safety, nutrition, and the impact of food label statements on attitudes and behavior.
  • Both qualitative and quantitative research projects are conducted as appropriate for study objectives.
  • Findings are shared within the FDA, presented at professional society and other meetings, and published in the peer-reviewed literature.
Program would be strengthened if: 
  • Activities were organized/mapped to illustrate a clear progression from issue identification to tracking response.
  • The Agency clearly identified how they would utilize information gathered through qualitative and quantitative research to address priorities.
  • Topics addressed orally would be published in the peer-review literature.
  • Delay due to OMB procedures to clear consumer research studies to proceed would be resolved.

Slide 26

Discovery, Remediation, Resolution is a Continuum

Now and in the Future,
Communication with Stakeholders--
Especially the Consumer--Is Key

Slide 27

Research Prioritization:

Successful programmatic and regulatory outcomes require:

  • Use of science-based risk assessment,
  • Prioritization system
  • Management protocols
  • Project outcomes must support strategic outcomes.
Resources:
  • Sufficient resources are essential and are lacking. 
Office of Cosmetics: 
  • Limited review, lack of familiarity (regulatory authority, framework)
  • Separate review recommended

Slide 28

Internal:
  • Implement a system for research project management
  • Provide flexibility to improve recruitment and retention of research personnel and improve the ratio of support staff
  • Maintain a balanced portfolio of mission-relevant research. 
  • Give laboratory and non-laboratory research equal attention
  • Establish a routine process for issue/risk identification
  • Institute internal and external advisory panels for research prioritization
  • Perform separate reviews/assessments (Offices, COEs)
External:
  • Further develop CFSAN’s extramural research program
  • Stop being the best kept secret
  • Adopt a global approach to education, outreach and information sharing. 

Slide 29-31

Charge: Response to the Review Objectives

1+2.   Identify gaps in scientific expertise and technological capability in which CFSAN should increase efforts to ensure that it can address current and future demands + Review and recommend research areas where CFSAN might reduce, maintain or expand its current levels of research effort
 

Gaps

Laboratory Research

  •   Practical food processing research
  •   Nutrition research
  •   Newer technologies

Non-Laboratory

  • Consumer Research

Staffing

  • Support Staff
  • Succession Planning

Resources for both a reactive focus, to mitigate current problems in a more timely fashion, and a proactive focus, to anticipate and act on future problems.

3. Identify opportunities to leverage scientific programs through partnerships

  • Extramural Research Expansion
  • More Collaborations

4. Determine if CFSAN is doing what is needed to recruit, develop, and retain the professional expertise needed to address current and future challenges
 

  • More to develop scientists with a focus on applied food science, nutrition and communications
  • More support staff
  • More external interactions, engagement, professional development/recognition

5. Assess and recommend management and review practices for setting priorities to guide the direction of resources to the highest priority activities

  • Look at what’s been done, assess and implement
  • Internalize the Strategic Plan

6. Identify the most important future challenges facing the Center scientific research enterprise as well as the major institutional and systemic barriers to addressing them
 

 

Competing priorities
 
Loss of influence globally
 
Competing stakeholder interests
Loss of public confidence
Erosion of funding/resources
Institutional barriers, old mindsets, “N.I.H. Syndrome
Loss of relevance
Inability to identify/respond to current/emerging issues

Slide 32

Emerging Issues Map

Graph set up with no data

The y-axis is titled Impact: Low to High.  There is not a measure.

The x-axix is titled Timeframe: Immediate to Long-term.  The measures are Immediate (0-2yrs), Medium-term (2-5 yrs), and Long-term (> 5 yrs).

Slide 33-35

Wrap-Up

Reality and Challenges: 
  • Acceptance that role and responsibilities will continue to revolve and evolve around abilities to mitigate today’s problems AND anticipate and act on tomorrow’s crises. 
  • Status quo is not acceptable
  • Concurrent adaptation to continuously changing and increasing responsibilities, while:
    • Science advances and increases in complexity
    • Increased innovation in ingredients, foods and cosmetics
    • Increasing imports
    • Complex regulatory and risk environments
    • Resources remain static or decrease  
Commentary:
  • Essential to be both a leader and influencer in food safety, food science, food processing, nutrition and consumer science and communication—at home and abroad
  • Data and insights must inform regulatory decisions.
  • “Cutting edge” science is laudable but fundamental and applied regulatory research is a must
    • Risk analysis, food safety, food science, food processing, nutrition, communication science and regulatory science
  • Must not ignore the applied/practical/technology-oriented side of food science, nutrition and consumer science and communications
  • Review, assess reports completed to date, compare with the Strategic Plan, implement first those recommendations that are similar and will drive the Plan
  • Create opportunities, increase engagement—within the Agency, US and World
    • To retain, develop, attract future leaders and teams of excellence
    • Build CFSAN’s legacy/people pipeline
  • Establish a formalized and more structured process for prioritizing research
    • Be more open and inclusive  
    • Study the NTP Model
  • Establish a formalized process for identifying emerging issues
    • Utilize networks and increase external engagements   
    • Use of maps and scans

Slide 36

Final Words

Aspiration (Strategic Plan):  

The world’s preeminent government organization regulating foods and cosmetics to protect and promote public health
 

Goal (CRRS Report):

To be the best and “best in class” as a model by which other food regulatory agencies benchmark themselves

From Good to Great