Ruiqing Pamboukian, Ph.D. Office of Regulatory Affairs/Office of Regulatory Science

1. Where are we now and where are we going?- Collaborative Efforts to Promote ISO/IEC 17025:2005 Accreditation for the Nation's Food/Feed Testing Laboratories Ruiqing Pamboukian, Ph.D. Office of Regulatory Affairs/Office of Regulatory Science U.S. Food and Drug Administration Governmental Food and Feed Laboratories Accreditation Meeting San Diego, California March 9 - 12, 2015

2. Outline • Background • Why accreditation? • FDA’s collaborative efforts to promote ISO/IEC 17025:2005 accreditation for the nation's food/feed testing laboratories • ISO CAP Program Review – current standing • What do we expect to see next?

3. Driving Forces of Laboratory Accreditation

4. Laboratory Accreditation is the Key Building Block of the Nation’s Integrated Food/Feed Safety System • Laboratory Accreditation supports the production of reliable and defensible data • Using accredited laboratories can help establish and assure confidence for decision making to take regulatory action • Laboratory accreditation supports the effort to establish and implement the national standards throughout the country • Uniform inspectional coverage and sample collection and analysis • Greater use of each other’s analysis and observations in protecting public health

5. Timeline ISO CAP 2nd Annual meeting in Irvine, CA 2011 2013 2017 2012 2014 …… 2015 2010 ISO CAP 1st Annual meeting at Raleigh, NC FSMA Accreditation Rule is inthemaking • Model laboratory Standard ISO CAP 3rd extended Annual meeting in San Diego, CA PFP regroup 5

6. St. Louis Meeting - September 22-23, 2010 • Attendees • FDA, FSIS/USDA, APHL, AAFCO, AFDO • State laboratories • Objectives: • discuss the FDA Laboratory Accreditation Project • Achieve mutual agreement on accreditation plan • The FDA presented an overview of the food safety policies undergoing changes in Congress and the advantages of Laboratory Accreditation • FDA invited the attendees to engage in the design of a workable accreditation plan

7. Agreement in the St. Louis Meeting • To develop outreach activities to inform interested labs about the FDA Accreditation Program. • To provide an Initial Assessment based on ISO 17025, Gap Analysis, and a Time-line Plan to labs that commit to obtaining accreditation under the FDA assistance. • To determine milestones and accreditation costs within the timeline plan for the labs pursuing accreditation under FDA support. • To provide potential financial assistance based on the lab’s accreditation standing, economic resources, and progress on the pathway to accreditation. • To provide support for already accredited labs to maintain and expand their accreditation.

8. IFSS and PFP • Establishing a fully Integrated National Food Safety System with strengthened inspection, laboratory and response capacity • PFP -Partnership for Food Protection • the “Best practices Manual” • Regrouped recently to improve the document • laboratory accreditation has been identified as a critical element for ensuring the integrity and accuracy of laboratory analytical testing • Ensure defensible data • Data acceptance by regulatory agency • Working group established

9. Section 202 of FSMALaboratory Accreditation for Analyses of Foods 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

10. ISO CAP Program • Awards to 30 MFRPS laboratories for 5 years • OP, OAGSand ORS work together to provide management oversight and technical support

11. Guidance

12. ISO CAP Laboratory Progress

13. Current standing of the ISO CAP labs Percentage based on the Gap Analysis Number of the labs

14. Expectation for Year 4 • Non-accredited labs: • Accreditation application • Assessment or pre-assessment by ABs • Non-conformances and deficiencies • Accredited labs: • Maintain and expand their scope of accreditation • Continue on mentoring • Continue eLEXNET data entry • Continue Sampling Plan testing

15. Changes in quarterly calls • Group call replacing one-to-one call starting the 3rd quarter this year • Document review completed in prior to the group call • Progress verified for each individual lab through email • Group call to provide updates, to share information and best practices and to answer questions

16. ORS technical advisory group Ruiqing Pamboukian Angele Smith Karen Blickenstaff Dean Turco Peggy Carter Mohammed Islam Toni Morales Anthony Adeuya (former member) Ann Westermann (former member)

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) • Web based repository resource center and discussion board (APHL) • Ad Hoc Labs assistance (APHL, FDA) • Data Acceptance working group (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)

18. Program Outcomes • Increase the number of accredited food and feed testing laboratories • Increasetesting capacity by accredited laboratories • Increase the level of accountability in laboratory performance • Harmonize laboratory standards throughout the country • Enhance Federal-State partnerships in building the nation’s Integrated Food/Feed Safety System.

19. Vision for the Future • Continue to promote laboratory accreditation • Continue to Implement PFP best practices • Continue to Implement MFRPS and AFRPS • Develop and Implement FSMA model laboratory standards • State laboratories participate in National Surveillance Program • Greater use of state data for regulatory action • Coordinated, faster and more effective response to food safety events

20. Thank You!Ruiqing.Pamboukian@fda.hhs.gov