The FDA Foods Research Program
Developing Priorities and Partnerships for Success Under FSMA
Palmer A. Orlandi, Ph.D.
Acting Chief Science Officer and Research Director
Office of Foods and Veterinary Medicine, FDA
Tuesday, March 10, 2015
8:15-8:45 AM
What’s on Tap for Today’s Discussion
(…or how I’ll get you to your second cup of coffee on time)
 Science and FSMA
 The FDA Food & Veterinary Medicine Research Enterprise
 Research
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Risk-informed
Identifying gaps; Prioritizing research needs;
Evaluating efforts; Metrics for success
Integrating compliance and surveillance
 Partnerships-”synergistic success”
 Benefits and limitations
 The many forms to partnerships
 (PFP lab group)
 The present and future; successes and potential
The Hallmark of the Food Safety
Modernization Act (FSMA)
 Integrated approach to address potential hazards in FDA-regulate
commodities
 Ensure food safety both in domestically produced and imported foods
 Risk informed; Preventive in focus
FSMA & Science/Research
An Integrated Effort
Components of the FDA Food Safety Program:
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Standard Setting and Guidance
Communication and Outreach
Inspections and Compliance
Federal State Integration
Imports
Surveillance and Response
 Science Infrastructure
 Food Defense
 Animal Food and Feed
 Resources
The Food & Veterinary Medicine (FVM)
Research Enterprise
FVM Science and Research Steering
Committee, SRSC
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A Research and Methods Program to Support the Agency’s
Mission and Meet the Needs of its State and Commercial
Stakeholders
Unified Approach: between foods, feed, and veterinary
medicine program leadership; among researchers; and
between researchers and policy makers
Develop a single Foods and Veterinary Medicine Program
(FVM) Science and Research Strategic plan to strengthen
core science & research capabilities
Develop a process for prioritizing FVM Program research
Develop & implement a unified analytical methods
development & validation program aligned with FVM
Program priorities
Incorporate risk-informed hazard analysis; Integration of
surveillance and compliance activities
Innovative technology
Improve technology transfer to program offices and field
labs; lab capacity
Establish stakeholder partnerships ; leverage resources
and advance common objectives
FVM Active Research Projects
11%
19%
CFSAN
55%
15%
CVM
ORA
NCTR
Analytical Methods – Why Do They Matter?
Outbreak
Investigations
State &
Federal
Partner Labs
FDA Labs
Analytical
Methods
Surveillance &
Compliance
Enforcement
Private Labs
8
The FVM Science and Research Structure
FVM Governance
Board
Science and Research Steering Committee
Micro-RCG
Micro-MVS
CFSAN, CVM, ORA
Center & Line Management
TAGs
TAGs
Chem-RCG
Chem-MVS
Research Scientists, Lab Analysts, Investigators, Project Leads
Food Safety Officers, Feed Safety Officers, Compliance Officers
Annual Prioritization Plan, Annual Method Development Plan,
Method Validation, and Tracking/Resource Management (CARTS)
Technical Advisory Groups (TAGs)
Microbiology RCG TAGS
BAM Council
CBOT
Drug Resistance
High Impact Pathogens
Listeria
Micronauts
Molecular EPI
MMVS
Next Generation PCR
OMICS
Processing Controls
Salmonella
STEC
Virology
Chemistry RCG TAGS
Additives/Dietary Supplement
Allergens and Gluten Methods
Aquaculture Research Group
Chemandos
CMVS
DNA-Based Species Identification
Economic Adulteration Group
Elemental Analysis Steering Committee
FERN MDV Group
Interagency Residue Control Group
MDVP Advisory Group
Mycotoxins
Persistent Organic Pollutants
Pesticides Steering Committee
Portable Devices
Seafood Methods Steering Committee
Species ID
Targeted/Non-targeted Screening
Vet LRN
Veterinary Drug Residue and Animal Feeds
10
RESEARCH PLANNING
Risk Ranking
Hazard
Hazard
Hazard
Hazard
Risk
Hazard
Hazard
Risk
Risk
Risk
Hazard
Graphic from HG Claycamp
Public Health
Criteria
Worst risks
Risk
Risk
Risk
12
Risk-Informed Prioritization
Risk management decision-making may consider additional factors
Worst risks 
Mandates
Stakeholder
Concerns
Risk
Risk
Risk
Non-Public
Health Criteria
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Costs
Feasibility
of Mitigation
Risk
Management order 
Risk
The research prioritization process
 Assessing the project’s importance and the need for FVM collaboration.
 Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
The research prioritization process
 Assessing the project’s importance and the need for FVM collaboration.
 Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
 Addresses a Public Health/Animal Health Concern…
 Does this address a high-priority public health/animal health problem caused by
a food or feed adulterant? Is there an associated health risk for the general population;
or, a susceptible population e.g., food allergic persons?
The research prioritization process
Assessing the project’s importance and the need for FVM collaboration.
Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
Addresses a Public Health/Animal Health Concern
Impact…
Tightly linked to Element 1 and is based upon food safety needs, policy needs, and
consumer, societal, stakeholder sensitivities concerning risk. If successful, it will be
highly impactful and advance current science to serve these need/concerns
The research prioritization process
Assessing the project’s importance and the need for FVM collaboration.
Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
 Addresses a Public Health/Animal Health Concern
 Impact
 Research Helps to Inform a Risk-based Food Safety System; Supports
Preventive Controls…

If successful, what is the expected impact on the agency’s ability to establish and
implement preventive controls and to support the paradigm of a risk-based food
safety system?
The research prioritization process
Assessing the project’s importance and the need for FVM collaboration.
Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
 Addresses a Public Health/Animal Health Concern
 Impact
 Research Helps Inform a Risk-based Food Safety System; Supports
Preventive Controls
 Significant Knowledge Gap/Method Gap…
 Do we have an adequate body of scientific data with which to understand the issue
such that we can inform the public or otherwise adequately manage the issue?
The research prioritization process
Assessing the project’s importance and the need for FVM collaboration.
Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
Addresses a Public Health/Animal Health Concern
Impact
Research Helps Inform a Risk-based Food Safety System; Supports Preventive
Controls
Significant Knowledge Gap/Method Gap
Resource Needs and Allocation Concerns
The research prioritization process
Assessing the project’s importance and the need for FVM collaboration.
Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
Addresses a Public Health/Animal Health Concern
Impact
Research Helps Inform a Risk-based Food Safety System; Supports Preventive
Controls
Significant Knowledge Gap/Method Gap
Resource Needs and Allocation Concerns
Breadth of Applicability…
If successful, this will result in a method or procedure that has applicability to a wide
range of health risks, food matrices; or, provide high throughput capability, decrease
time-to-result, etc. (method development)
The research prioritization process
Assessing the project’s importance and the need for FVM collaboration.
Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
Addresses a Public Health/Animal Health Concern
Impact
Research Helps Inform a Risk-based Food Safety System; Supports Preventive
Controls
Significant Knowledge Gap/Method Gap
Resource Needs and Allocation Concerns
Breadth of Applicability
Capability to intervene once the research is successful…
What is the agency’s capability to intervene or to take action with the expected
knowledge or data that is likely to result from the project? Will this effort be useful for
mitigation; epidemiological value; inter-agency value.
The research prioritization process
 Assessing the project’s importance and the need for FVM collaboration.
 Prioritization tools – An evaluation/ranking application based on objective
metrics, such as:
 Addresses a Public Health/Animal Health Concern
 Impact
 Research Helps Inform a Risk-based Food Safety System; Supports
Preventive Controls
 Significant Knowledge Gap/Method Gap
 Resource Needs and Allocation Concerns
 Breadth of Applicability
 Capability to intervene once the research is successful
 Extent to Which the ERO Aligns to the Strategic Outcomes and Knowledge
Gaps for more Than One Organization…
 This criterion evaluates the extent to which a particular project is a priority for more
than one Center; and, the level of inter-center collaboration and coordination that may
be needed.
Hazard/Risk-based Surveillance Strategies
The Future-state Vision
Redefining our approach to surveillance;
developing a strategic testing program that leads
to safer foods by better targeting and more
efficient use of laboratory resources through the
systematic identification of high risk commodities
and an associated hazard i.e. microbial
pathogen, chemical analyte, etc.
Determine
Priorities for
Testing
Collect Existing
Internal and
External Data
Ensure Methods
Developed for
Sampling Needs
An Iterative
Surveillance
Sampling
Process
Refinement and
Reprioritization
Use Data to
Inform FDA
Activities
Collect and
Analyze Baseline
Samples
What Do We Need to Succeed?
“C“…you
oming
is atogether,
beginning.
gettogether
three ants
they
can’t do [anything]. You get 300
Keeping
together
is progress.
million of
them, they
can build a
Wcathedral.”
orking together is success.”
Annie Savoy, Bull Durham
Henry Ford
(a wise sage of baseball)
Partnership
One of two or more entities engaged in the same enterprise;
sharing its profits and risks; each an agent for the other…
Synergy
“The whole is greater than the sum of its parts”
The Value in Partnerships
 Leveraging.
 Overcoming narrow myopic thinking
 Foster the development of emerging technologies to rapidly detect microbial and
chemical hazards in food.
 Meeting the needs of the FDA and stakeholder constituencies alike.
 Facilitate and promote cooperation and collaboration between FDA, Federal
partners, academia and regulated industry
 Harnessing the expertise and resources of the private sector to achieve mutual
food safety goals.
 Accelerated Technological Advancements
 improve both FDA’s and industry’s ability to detect signals of intentional and
unintentional food contamination
 provide useful information to help focus limited resources on the highest risks.
The Spectrum of Partners to Achieve FSMA Goals
Beyond the Bounds of the FVM Research Enterprise
Benefits of Partnership
 Basic & Applied Research;
 Innovation and Technology;
 Regulatory capabilities/Capacities
Limitations
 FDA, the regulator
 Conflicts of interest
Broad Spectrum of FDA Partnerships
FDA Broad Agency Announcement (BAA)
Solicitation for Advanced Research and Development for Regulatory
Science to support the FDA Strategic Plan for Regulatory Science
1. Modernize Toxicology to Enhance Product Safety
2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve
Product Development and Patient Outcomes
3. Support New Approaches to Improve Product Manufacturing and Quality
4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
5. Harness Diverse Data through Information Sciences to Improve Health Outcomes
6. Implement a New Prevention-Focused Food Safety System to Protect Public Health
7. Facilitate Development of Medical Countermeasures to Protect Against Threats to
U.S. and Global Health and Security
8. Strengthening Social and Behavioral Science at FDA by Enhancing Audience
Understanding
9. Strengthening the Global Product Safety Net
FDA Partnerships
BAA’s, CERSIs, and COE’s
 Centers of Excellence in Regulatory
Science and Innovation (CERSI)
 Harnessing new technologies
 Critical Path initiative; Advancing Regulatory Science
 UMD, GU, UCSF and Stanford, JHU
 FDA/CFSAN Centers of Excellence (COEs)
 National Center for Food Safety and Technology (IFSH/NCFST/IIT)
 Joint Institute for Food Safety and Applied Nutrition (JIFSAN/UMD)
 National Center for Natural Products Research – FDA COE on Botanical Dietary
Supplement Research (NCNPR/UM)
 Western Center for Food Safety (WCFS/UC- Davis)
The Food Emergency Response Network
Mission:
Integrate the nation’s multilevel food-testing laboratories to detect, identify, respond
to and recover from a bioterrorism or public health emergency/outbreak involving the
food supply
 Detection - Identification of biological, chemical and radiological threat agents
 Prevention - targeted federal/state surveillance sampling programs
 Preparedness - strengthen lab capacities and capabilities (method development)
 Response - surge capacity
 Recovery - assure consumers of safety via food testing
The Integrated Food Safety System
(IFSS)
 The Food Safety Modernization Act called for enhanced partnerships and
provided a legal mandate for IFSS.
 Governed by the by Coordinating Committee (CC), composed of 11
representatives from FDA’s Council of Association President’s and several
at-large members from state and local jurisdictions plus federal
representatives from FDA, CDC, USDA/FSIS and DHS.
 Key elements of the system
 Developing national standards for inspection, laboratory analysis, and sample
collection
 Creation of a national work plan to ensure coverage of domestic food facilities
 Developing training and certification programs
 Coordinated emergency response
 Currently composed of 10 task groups that have joint federal, state/local
leadership
IFSS Structure & Task Groups
LTG Mission:
Association of American Feed Control Officials (AAFCO)
Association of Food and Drug Officials (AFDO)
Association of Public Health Laboratories (APHL)
Association of State and Territorial Health Officials (ASTHO)
Council of State and Territorial Epidemiologists (CSTE)
National Association of Country and City Health Officials (NACCHO)
National Association of Local Boards of Health (NALBH)
National Association of State Animal Health Officials (NASAHO)
National Association of State Departments of Agriculture (NASDA)
National Environmental Health Association (NEHA)
United States Animal Health Association (USAHA)
Develop and Implement
national standard laboratory
practices and procedures to
promote consistent and
meaningful data among
federal, state, and local
laboratory agencies from
environmental and
food/feed samples for
compliance and surveillance
to support mutual
acceptance of laboratory
analytical data.
The Lab Task Group, LTG
 Comprised of seven subcommittees to develop standards in
the following areas
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Accreditation
Methods
National Proficiency Testing
Regulatory Requirements
Reporting
Analytical Worksheet Packages
Sampling
 Goal is to provide guidance:
 For labs participating in any federal-derived testing program
(MFRPS, FERN CAP)
 For any lab testing in support of federal regulatory action
 To facilitate submission of meaningful and actionable data to all regulatory
 agencies
FDA Partnerships
International
US and Mexico Produce Safety Partnership
FDA – SENASICA – COFEPRIS
FDA and the Canadian Food Inspection
Agency (CFIA)
Global Food Safety Partnership (GFSP)
Global Microbial Identifier (GMI)
Partnerships and Innovation
Whole Genome Sequencing Program (WGS)
Genome Trakr
• State and Federal laboratory network
collecting and sharing genomic data
from foodborne pathogens
• Distributed sequencing based network
• Partner with NIH
• Open-access genomic reference
database
•
http://www.ncbi.nlm.nih.gov/bioproject/183844
• Can be used to find the contamination
sources of current and future outbreaks
http://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/default.htm#trakr
External labs
FDA labs
24 labs, historical strains and real time surveillance isolates
External Labs
Alaska
Hawaii
New Mexico
Arizona
Texas
Minnesota
New York
NY agriculture
Maryland
Virginia
W Carolina U
USDA-FSIS
Florida
Argentina
SECRETARY PICK!
CFSAN, CDC, NIH, USDA Partnership
Potential biggest transformation of public health microbiology in decades
New technology has the capacity to revolutionize foodborne disease
tracking by replacing current methods
Partnerships and Innovation
Public-Private Partnerships
 America COMPETES Act; the President’s Strategy for American
Innovation
 Granted Agencies authority to offer prize competitions
 Use Grand challenges as an innovation tool to engage the public
 Ambitious goals – catalyze breakthroughs
 Pay only for success
 Leveraging outside novel approaches
Open innovation challenge efforts
 FDA/Federal Partners/Industry co-aligned interests: rapidly detecting foodborne pathogens
 Largest benefit could be gained by making significant advances in pre-enrichment phase of
microbiological testing
 Rapidly recovering enough target organisms or genetic material for current detection/sensor
technology platforms
 Sept. 23rd, 2014 – Food Safety Challenge Announced:
“Improvement and Validation of Methods for the Detection of Microbial Foodborne Pathogens”
Partnerships and Innovation
2014 Food Safety Challenge
Partnerships and Innovation
The Reagan-Udall Foundation
OVERVIEW
 Not-for-profit organization created by Congress in 2007 to support the mission
of the FDA by advancing regulatory science and research
 A unique funding environment for FDA, its stakeholders (academia, industry)
and other federal agencies to work together in a collaborative, transparent way
on mutual regulatory science projects
FUNDING
 FDA funds specifically prescribed under the statute to be appropriated to the
FDA and then transferred to the Foundation ($500k-$1.25m)
 Donations from not-for-profits
 Funding and in-kind contributions for programs come from project and program
partners, to support the project or program in which they are participating.
Project or program partners can be foundations and other non-profits,
government entities, or industry companies.
Partnerships and Innovation
The Reagan-Udall Foundation
GOVERNANCE
 The Foundation’s Board of Directors is a 17-member Board comprised of
representatives from:
 patient/consumer advocacy groups
 academic research institutions
 the general pharmaceutical, device, food, cosmetic, and biotechnology
industries
 health care providers
 at-large representatives who are experienced experts.
 Ex-officio members include two leading government scientists, namely the
Commissioner of the FDA and the Director of the National Institutes of
Health.
Partnerships and Innovation
IAFP Professional Development Group (PDG)
“Advanced Molecular Detection Analytics (AMDA)” formed in 2014
Mission
To provide a forum for the exchange and sharing of information related to the
development and use of advanced molecular approaches for the detection and
identification of microbial contaminants of food and related commodities.
Outreach
Encourage partnerships among representatives having diverse technical and
clinical expertise among the myriad of next-generation pathogen detection
technologies and bioinformatics to increase and disseminate knowledge
regarding cutting edge technologies and applications to meet evolving
food safety needs.
Partnerships and Innovation
(coming soon)
Partnerships and Innovation
(coming soon)
Consortium for Sequencing the Food Supply
Chain
• IBM and Mars, Inc will
study the microbial
ecology of foods and
related processing
environments
• Sequencing ALL
microorganisms
– Microbiome
http://www.research.ibm.com/client-programs/foodsafety/index.shtml
FDA Science and Research
The
Big
Picture
Infrastructure Goals
(…the big finish)
PARTNERSHIPS
CAPACITY BUILDING/HARMONIZED STANDARDS
MUTUAL RELIANCE
SURVEILLANCE
DATA SHARING
The Integrated Effort Between
FSMA & Science/Research
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




Standard Setting and Guidance
Communication and Outreach
Inspections and Compliance
Federal State Integration
Imports
Surveillance and Response
 Science Infrastructure
 Food Defense
 Animal Food and Feed
 Resources
THANK YOU
Palmer A. Orlandi, Ph.D.
Acting Chief Science Officer
FDA Office of Foods and Veterinary Medicine
Email: Palmer.Orlandi@FDA.HS.GOV