1 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 , 2015 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

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? 2

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

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 4

Timeline 5 5 St. Louis Meeting (APHL, AFDO, AAFCO, USDA/FSIS, and FDA ) – initiation of the FDA/Sate laboratory accreditation plan IFSS & PFP MFRPS - Standard 10 contract FSMA (section 202) 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 2 nd Annual meeting in Irvine, CA 2015 ISO CAP 3 rd extended Annual meeting in San Diego, CA PFP regroup ……

St. Louis Meeting - September 22-23, 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

Agreement in the St. Louis Meeting 7 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.

IFSS and PFP 8 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

Section 202 of FSMA Laboratory Accreditation for Analyses of Foods 9 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

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

Guidance 11 Standard Purchase ISO training Establish QA manager Scope of Accreditation Action Plan Proficiency Testing Quality Manual/SOPs Internal Audit/Manage ment Review Mentor/Mentee program

ISO CAP Laboratory Progress 12 Year 1Year 2Year 3 From where to start? Standard purchase ISO training QA manager Scope determination PT enrollment Quality Manual Initial assessment Building Quality System Filling the gaps - improving quality system PT Training SOPs Mentor/mentee activities Sampling Agreement in preparation Implementing Quality system QMS improvement PT- continue Training- continue SOPs Internal audit Management review Pre-assessment Sampling plan implemented

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

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 14

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

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) 16

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) 17

Program Outcomes 18 Increase the number of accredited food and feed testing laboratories Increase testing 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.

Vision for the Future 19 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

Thank You! 20