1. 1 Ruiqing Pamboukian, Ph.D. Office of Regulatory Affairs/Office of Regulatory Science U.S. Food and Drug Administration 2 nd Governmental Food and Feed Laboratories Accreditation Meeting Louisville, Kentucky February 2-4, 2016 Laboratory Accreditation – a Key Building Block for the Integrated Food/Feed Safety System -FDA’s Collaborative efforts on promoting laboratory accreditation for nation’s food/feed testing laboratories

2. Outline Why accreditation? Laboratory accreditation program timeline ISO CAP Program Review –Where are we now –Where are we going Collaborative efforts to promote ISO/IEC 17025:2005 accreditation for the nation's food/feed testing laboratories Future direction 2

3. Driving Forces of Laboratory Accreditation 3 IFSS PFP Integrated Food/Feed Safety System Partnership for Food Protection MFRPS AFRPS Manufactured Food Regulatory Program Standards Animal Feed Regulatory Program Standards FSMA Food Safety Modernization Act

5. Why accreditation? Laboratory Accreditation supports the production of reliable and defensible data Using accredited laboratories provides decision makers confidence when taking regulatory action Laboratory accreditation supports establishing and implementing national standards 5

6. Accreditation Timeline 201020112012201320142015201620172020 6 St. Louis Meeting (APHL, AFDO, AAFCO, USDA/FSIS, and FDA ) – initiation of the FDA/Sate laboratory accreditation plan ISO CAP –5-yrs grant, awarded 31 state laboratories Association CAP – awarded APHL, AAFCO, AFDO ISO CAP –5-yrs grant, awarded 31 state laboratories Association CAP – awarded APHL, AAFCO, AFDO ISO CAP 1 st Annual meeting at Raleigh, NC FSMA Accreditation Rule is in the making Model laboratory Standard ISO CAP 1 st Annual meeting at Raleigh, NC FSMA Accreditation Rule is in the making Model laboratory Standard ISO CAP 2 nd Annual meeting in Irvine, CA AFRPS-Std.10 ISO CAP 2 nd Annual meeting in Irvine, CA AFRPS-Std.10 -ISO CAP 3 rd Annual meeting joined w/ MFRPA in San Diego, CA -ISO Food CAP extended to 6 additional labs -AFRPS ISO CAP (20 new feed labs) -PFP regroup -Data Acceptance working group -ISO CAP 3 rd Annual meeting joined w/ MFRPA in San Diego, CA -ISO Food CAP extended to 6 additional labs -AFRPS ISO CAP (20 new feed labs) -PFP regroup -Data Acceptance working group 2 nd Governmental Food/Feed Lab Accreditation Meeting, Louisville, KY All 30 ISO food CAP labs are accredited! All food and feed ISO CAP labs are accredited! IFSS & PFP FSMA (section 202) MFRPS- Standard 10 contract(23 labs) – IFSS & PFP FSMA (section 202) MFRPS- Standard 10 contract(23 labs) –

7. Section 202 of FSMA Laboratory Accreditation for Analyses of Foods 7 Key Deliverables Establish lab accreditation program –Develop a process and criteria for recognition and accreditation –Develop a process and criteria for periodic review –Develop model standards for testing labs –Develop internal database to support program Establish public registry of recognized ABs and accredited labs Accredited labs to conduct food testing –Develop process for electronic submission of data Develop process for reviewing State/local labs results for purposes of recall, CE activities

8. Section 202 of FSMA Laboratory Accreditation for Analyses of Foods 202(b) – Testing Procedures Required testing of Act to be done by accredited labs when testing is conducted “by or on behalf of an owner or consignee” in cases of: –identified or suspected food safety problem –Import Alerts

9. ISO CAP ISO 17025:2005 Accreditation CAP (Food) –Awarded 31 labs in 2012 –Expansion in 2015 w/ 6 new labs AFRPS CAP + ISO Option (Animal Food) –Awarded 20 labs in 2015 –Anticipated expansion in the near future OP, OAGS and ORS work together to provide management oversight and technical support 9

10. 10 ISO CAP labs (food) funded in year 2012 AK Alaska Department of Environmental Conservation CA Department of Public Health CT Agricultural Experiment Station CT Dept. of Public Health FL Dept of Agriculture & Consumer Services GA Dept. of Agriculture IA University of Iowa IL Department of Public Health IN State Department of Health KS State of Kansas KY Cabinet for Health & Family Services MA Department of Public Health MD Dept. of Health & Mental Hygiene MI Dept of Agriculture MN Dept of Agriculture MO Dept of Health and Senior Services MS State University NC State Dept of Agriculture and Consumer Services NE State of Nebraska, Dept of Agriculture NY State Dept. of Agriculture and Markets OH Dept of Agriculture OR Dept of Agriculture RI State of RI and Providence Plantations SC Dept. of Health and Environmental Control TX Dept of State Health Services VA Division of Consolidated Laboratory Services VT State Agency of Human Services WA State Dept of Agriculture WI Dept of Agriculture, Trade & Consumer Protection WV State Dept of Agriculture ISO CAP labs (food) extension- funded in 2015 Alabama Dept. of Health Colorado Dept. of Public Health Louisiana Dept. of Public Health Nevada State Public Health Tennessee Dept. of Ag Wyoming Dept. of Ag AFRPS ISO CAP labs – newly funded in 2015 CA Dept. of Food & Agriculture CO Dept. of Agriculture/Biochem. Lab CT Ag. Experiment Station FL Dept. of Agriculture & Consumer Services GA Dept. of Agriculture IA Dept. of Agriculture IL Dept. of Agriculture KS Dept. of Agriculture LA Dept. of Agriculture & Forestry MN Dept. of Agriculture MO Dept. of Agriculture NC Dept. of Agriculture NE Dept. of Agriculture NJ Dept. of Agriculture New Mexico Department of Agriculture (NMDA) Office of TX State Chemist PA Dept. of Agriculture TN Dept. of Agriculture WA Dept. of Agriculture WV Dept. of Agriculture (Regulatory and Environmental Affairs Division (READ) Yellow – already accredited at the time received the grant Green – accredited in the past two years

11. 11 Alabama Arizona Arkansas California Colorado Florida Georgia Idaho IllinoisIndiana Iowa Kansas Kentucky Louisiana Maine Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Connecticut Delaware Maryland New Jersey Rhode Island Alaska Hawaii Sates in both MFRPS and AFRPS ISO CAP MFRPS ISO CAP only AFRPS ISO CAP only Neither MFRPS ISO CAP nor AFRPS ISO CAP

12. ORS Laboratory Accreditation Program Objectives: Provide technical assistance to the awarded laboratories that are seeking and/or maintaining their accreditation Provide OP with administrative and technical support in managing the grant by monitoring the laboratory progress and making recommendations for future funding Oversee and provide guidance on the laboratory accreditation component of the three lab associations’ cooperative agreement program (AFDO, AAFCO and APHL) –Efforts focused on coordinating ISO accreditation training, improving mentor-mentee program, overseeing the Ad Hoc laboratories accreditation assistance and facilitating the planning of yearly national laboratory accreditation program meeting 12

13. Program Efforts 13 Developed and implemented yearly program guidance outlining all deliverable timelines – e.g. quarterly action plan required One-to-one assistance by assigning ORS personnel to each of the labs, conducting monthly and quarterly calls On-site assessment and technical assistance (e.g. 23 on-site visits in 2012) –Expected 16 on-site visits in 2016 (January to May) GAP analyses on lab quality systems Instituted the Mentor-mentee program Organized and hosted program face-to-face meetings (2013 and 2014) Organized educational webinars targeting hard to understand ISO concepts Reviewed mid-year and end-of-year report for each of the awardee and provided written ORS evaluation reports every mid-year and end-of-year for each of the lab Worked closely with OP project officers to resolve issues and approve carryover and purchase request Made recommendations to OP based on the progress of each individual lab

14. Deliverables 14 Action Plan ISO Training Establish QA manager Scope of Accreditati on Proficiency Testing Quality Manual/SO Ps Internal Audit/Man agement Review Sampling Agreement and Plan FERN activities eLEXNET data sharing Mentor- mentee program

15. Mentor – Mentee Program Each non-accredited lab is paired up with an accredited lab Mentor labs work together with their mentee labs and their ORS advisor to make a plan of their accreditation needs Quarterly group technical call for Q & A’s are held Examples of best practices for program: –Invited mentee labs for on-site visit –Scheduled conference call with mentee labs to answer questions and address specific issues –Provide documents that can be tailored for lab’s own need - SOPs, Quality Manual, forms, work instructions, etc. –Answer question on ad hoc basis 15

16. Sampling Agreement Successful Stories The Blue Bell Ice Cream recall South Carolina Department of health Jen’s Splendid Ice Cream recall Nebraska Department of Agriculture –Their good quality system ensured data accountability and acceptance. 16

17. Examples of collaborative efforts with the associations on supporting ISO accreditation FDA funded three associations: APHL, AFDO, AAFCO Co-Ag steering committee (APHL, AFDO, AAFCO and FDA) Collaborative training efforts (FDA, APHL,AAFCO, AFDO) Governmental Laboratory Accreditation Meeting (AFDO, APHL, FDA) Web based repository resource center and discussion board (APHL) – new features added to the discussion board Ad Hoc Labs assistance (APHL, FDA) Data Acceptance working group (APHL, FDA) PFP Laboratory Task Group – Best practices document (APHL, FDA) Sampling working group – GOODSample document (AAFCO) Check Sample Program (AAFCO) QA/QC guidelines (AAFCO) Development of a competency based career spanning training curriculum framework (AFDO) 17

18. Program Impacts and Outcomes Building strong collaborations among partners from federal, state, industry and associations –Three annual program face-to-face meetings were held since 2013 Best practices on laboratory quality systems were shared with grant awardees, accreditation bodies and three food safety associations (APHL, AFDO, AAFCO) Meetings served as a forum for educational and training opportunities for ISO accreditation-related topics through presentations and technical sessions Served as a forum providing networking opportunities –Training provided in collaboration with associations and accreditation bodies Enhancing state-to-state relationship through the mentor-mentee program Increasing number of accredited food/feed testing laboratories –Improved data quality and thus data acceptance –Increased laboratory testing capability and capacity Enhancing Federal-State partnerships in building the Nation’s Integrated Food/Feed Safety System. 18

19. Vision for the Future 19 Continuation of laboratory accreditation program –Implementation of PFP best practices –Implementation of MFRPS and AFRPS lab standards Increased utilization of accredited state labs: –participation in National Surveillance Programs –Greater use of state data for regulatory action Sustaining accreditation Increased collaboration with FDA laboratory Coordinated, faster and more effective response to food safety events due to production and acceptance of laboratory analytical data.

20. Acknowledge ORS: Timothy McGrath Don Burr Angele Smith Karen Blickenstaff Peggy Carter Dean Turco Shari Kahn Srinivasulu Chigurupati Sarah Skorupsky Heather Hawk Tina Cai 20 OP: Abe Brown Erin Woodom-Coleman Teresa Bill OP SIS Auditing Team APHL AFDO AAFCO

21. ORS ISO: Ruiqing.Pamboukian@fda.hhs.gov Ruiqing.Pamboukian@fda.hhs.gov 21 OP AFRPS ISO Teresa Bills Teresa.bills@fda.hhs.gov OP MFRPS ISO: Erin Woodom-Coleman Erin.woodom-coleman@fda.hhs.gov