1. 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

2.  Science and FSMA  The FDA Food & Veterinary Medicine Research Enterprise  Research 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 What’s on Tap for Today’s Discussion (…or how I’ll get you to your second cup of coffee on time)

3.  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 The Hallmark of the Food Safety Modernization Act (FSMA)

4. FSMA & Science/Research An Integrated Effort  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 Components of the FDA Food Safety Program:

5. The Food & Veterinary Medicine (FVM) Research Enterprise

6. FVM Science and Research Steering Committee, SRSC  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

7. 15% 19%

8. 8 Analytical Methods Surveillance & Compliance Outbreak Investigations Enforcement FDA Labs State & Federal Partner Labs Private Labs Analytical Methods – Why Do They Matter?

9. FVM Governance Board Science and Research Steering Committee Micro -RCG Chem -RCG Micro- MVS CFSAN, CVM, ORA Center & Line Management CFSAN, CVM, ORA Center & Line Management Research Scientists, Lab Analysts, Investigators, Project Leads Food Safety Officers, Feed Safety Officers, Compliance Officers Research Scientists, Lab Analysts, Investigators, Project Leads Food Safety Officers, Feed Safety Officers, Compliance Officers Chem- MVS TAGs Annual Prioritization Plan, Annual Method Development Plan, Method Validation, and Tracking/Resource Management (CARTS) Annual Prioritization Plan, Annual Method Development Plan, Method Validation, and Tracking/Resource Management (CARTS) The FVM Science and Research Structure

10. 10 BAM Council CBOT Drug Resistance High Impact Pathogens Listeria Micronauts Molecular EPI MMVS Next Generation PCR OMICS Processing Controls Salmonella STEC Virology 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 Microbiology RCG TAGS Chemistry RCG TAGS Technical Advisory Groups (TAGs)

11. Risk- Capabilities-Gap Analysis-Prioritization RESEARCH PLANNING

12. Risk Ranking 12 Hazard Public Health Criteria Risk Worst risks  Graphic from HG Claycamp

13. Risk-Informed Prioritization Non-Public Health Criteria Risk Worst risks  Management order  Costs Feasibility of Mitigation Mandates Stakeholder Concerns Risk management decision-making may consider additional factors

14. 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:

15. 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?

16. 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

17. 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?

18. 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?

19. 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

20. 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)

21. 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.

22. 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.

23. 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.

24. Collect Existing Internal and External Data Determine Priorities for Testing Ensure Methods Developed for Sampling Needs Collect and Analyze Baseline Samples Use Data to Inform FDA Activities Refinement and Reprioritization An Iterative Surveillance Sampling Process

25. What Do We Need to Succeed? “…you get three ants together, they can’t do [anything]. You get 300 million of them, they can build a cathedral.” Annie Savoy, Bull Durham (a wise sage of baseball) “C oming together is a beginning. K eeping together is progress. W orking together is success. ” Henry Ford

26. Partnership One of two or more entities engaged in the same enterprise; sharing its profits and risks; each an agent for the other… “The whole is greater than the sum of its parts” Synergy

27.  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 Value in Partnerships

28. 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 Benefits of Partnership  Basic & Applied Research;  Innovation and Technology;  Regulatory capabilities/Capacities Limitations  FDA, the regulator  Conflicts of interest

29. Broad Spectrum of FDA Partnerships 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 Broad Agency Announcement (BAA) Solicitation for Advanced Research and Development for Regulatory Science to support the FDA Strategic Plan for Regulatory Science

30.  Centers of Excellence in Regulatory Science and Innovation (CERSI) Science and Innovation (CERSI) Harnessing new technologies Critical Path initiative; Advancing Regulatory Science UMD, GU, UCSF and Stanford, JHU FDA Partnerships BAA’s, CERSIs, and COE’s  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)

31. 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

32. 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

33. IFSS Structure & Task Groups LTG Mission: 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. LTG Mission: 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. 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)

34.  Comprised of seven subcommittees to develop standards in the following areas 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 The Lab Task Group, LTG

35. 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)

36. Partnerships and Innovation Whole Genome Sequencing Program (WGS) http://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/default.htm#trakr 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

37. External labs FDA labs External Labs Alaska Hawaii New Mexico Arizona Texas Minnesota New York NY agriculture Maryland Virginia W Carolina U USDA-FSIS Florida Argentina 24 labs, historical strains and real time surveillance isolates

38. 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

39. 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. 23 rd, 2014 – Food Safety Challenge Announced: Improvement and Validation of Methods for the Detection of Microbial Foodborne Pathogens” “ Improvement and Validation of Methods for the Detection of Microbial Foodborne Pathogens”

40. Partnerships and Innovation 2014 Food Safety Challenge

41. 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.

42. 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 The Reagan-Udall Foundation

43. 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.

44. Partnerships and Innovation (coming soon)

45. 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 Partnerships and Innovation (coming soon)

46. FDA Science and Research Infrastructure Goals PARTNERSHIPS CAPACITY BUILDING/HARMONIZED STANDARDS MUTUAL RELIANCE SURVEILLANCE DATA SHARING The Big Picture (…the big finish)

47.  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 Integrated Effort Between FSMA & Science/Research

48. Palmer A. Orlandi, Ph.D. Acting Chief Science Officer FDA Office of Foods and Veterinary Medicine Email: Palmer.Orlandi@FDA.HS.GOV THANK YOU