Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed

1. Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed APHL, AAFCO, AFDO Five-Year Cooperative Agreement

2. The AAFCO Perspective Nancy Thiex, AAFCO Lead Investigator and AAFCO Cooperative Agreement Administrator

3. Overview • Cooperative Agreement (CoAg) Objectives • Specific Aims & Specific Aims • AAFCO Led Activities • Progress to Date • Upcoming Work • The Volunteers • Questions

4. Cooperative Agreement Objectives • Laboratory accreditation • Developing laboratory training programs around accreditation topics. • National consensus on the sharing of analytical data • Improving communication among federal, state and local testing laboratories and their associated regulatory and public health programs • Expanding a proficiency testing program for feed laboratories • Strengthening partnerships with clinical laboratories

5. Cooperative Agreement Specific Aims • CoAg has 9 Specific Aims – General areas of work to accomplish broad objectives • Each Specific Aim has associated Activities designed to accomplish the objective of the Aim. Generally, there are several Activities for each Aim. • CoAg utilizes the committee structure of APHL, AAFCO, AFDO to carry out the Activities. • Each Activity has one of the three associations leading the effort. Volunteers may come from any/all.

6. Specific Aim 8 -AAFCO Lead Specific Aim #8: Use association infrastructure to develop an integrated approach to assist food and animal feed testing laboratories to achieve, maintain, and enhance the scope of laboratory accreditation and achieve conformance with applicable program standards as establish by the Secretary. • AAFCO Collaborative Check Sample Program (CCSP) Committee and Advisors • AAFCO Laboratory Methods and Services Committee (LMSC) and Advisors

7. AAFCO Led Activities– Aim 8 • Accreditation of the Collaborative Check Sample Program to ISO/IEC 17043. • Workgroup Chair: Dr. Victoria Siegel (IN) • Expansion of the Scope of the Collaborative Check Sample Program. • Workgroup Chair: Dr. Victoria Siegel (IN) • Revision of the AAFCO Quality Assurance/Quality Control Guidelines for State Feed Laboratories. • Workgroup Chairs: Brenda Snodgrass (OK) and Louise Ogden (MN)

8. Specific Aim 2 -AAFCO Lead Specific Aim #2: Identify, pilot test, and implement nationally the policies and procedures necessary to establish equivalency between federal, state and local food and feed testing laboratories. • Sampling and Sample Handling Working Group administered as a Working Group of: • AAFCO Inspection and Sampling Committee • AAFCO Laboratory Methods and Services Committee and Advisors.

9. AAFCO Led Activities – Aim 2 • Convene a Sample Handling Working Group to establish policies and procedures for sample collection, shipment, analysis, storage and retention. Members will be drawn from AAFCO, AFDO, APHL and FDA, as appropriate, and be representative of laboratory and inspection staff. • Workgroup Chair: Nancy Thiex

10. Progress to Date

11. Accreditation of the AAFCO CCSP to ISO/IEC 17043 • The Committee is the Working Group. • Consultant contracts in place. • Face-to-face meetings Jan 22 in Albuquerque, NM • Data Reporting Website was moved to a new host server at FASS to facilitate necessary website improvement. • Contract in place with FASS to translate the website to code compatible with their site.

12. Accreditation of the AAFCO CCSP to ISO/IEC 17043 • QuoData Workshop on Proficiency Testing Data Analysis was attended by Vicki Siegel. • The Check Sample Program Quality Systems Manual first draft is complete and is being converted to a format consistent with the G13 Checklist. • The Quality Oversight Team is established. • A Web Forum for the Quality Oversight Team has been established.

13. Expansion of the Scope of the AAFCO CCSP PT • Pet Food Add-On complete (quarterly program). Opened for enrollment on Oct. 26, 2012. • The first sample, a poultry meal sample, shipped to 45 labs on February 28, with results due April 10th 2013. Data has been analyzed and reported back to participants. Sixty-one participants reported data for 63 analytes using 156 methods. • The second quarter sample is flaked soy flour and in preparation.

14. Expansion of the Scope of the AAFCO CCSP PT Residue Detection Program. • Method codes for “heavy” metals and mycotoxins have been added to the program. • Participants are reporting data. • Crawford is using the data to develop approaches to the statistical analysis of residue data. Drug and Antibiotics Expansion.

15. Revision of the “QA/QC Guidelines for State Feed Laboratories” • Working Group populated. • FoodshieldWorkGroup developed to house documents and facilitate conference call meetings. • Monthly conference calls held for the working group with weekly calls between the Working Group chairs. • Face-to-face meetings Jan 24 in Albuquerque, NM and February 28 in Oklahoma City, OK. • Training Event February 25-29 in Oklahoma City, OK - ISO/IEC Lead Assessor/Auditor Training Course.

16. Revision of the “QA/QC Guidelines for State Feed Laboratories” • Consensus on format of deliverable & will include a copy of the ISO/IEC 17025:2005. • Work on writing underway.

17. Sample & Sample Handling Working Group • Working Group populated. • Consultant contract in place. • Biweekly conference calls held • FoodshieldWorkGroupdeveloped to house documents and facilitate conference call meetings. • Face-to-face meeting Jan 25 in Albuquerque, NM • Training Event April 2-5, Dallas, TX “Sampling for Defensible Decisions: Food and Feed” on the basics of the Theory of Sampling

18. Sample & Sample Handling Working Group • Consensus on deliverable / document(s). Guidelines for developing a sampling protocol. • Established a listing of state contacts for Sampling Food/Feed • Conducted a survey related to Sampling needs, issues, concerns, resources • Section Headers for main document identified • Definitions have been drafted. • Working on consensus for the content of each Section in the document.

19. What’s Next – Getting our ducks in a row!!

20. Accreditation of the AAFCO CCSP to ISO/IEC 17043 • Complete the Quality Manual • Review of the Quality Manual by the QOT. • Complete audits of the Subcontractors by the Manager: Sample Preparation Facility and Programmer. • Audits of Manager by the QOT. • Preparation and submission of the application to Accreditation Body • Assessment by the Accreditation Body

21. Expansion of the Scope of the AAFCO CCSP PT Residue Detection Program. • Develop the residue statistical approach • Complete the necessary programming and website modifications • Develop the report • Purchase spiked feed materials for the program Drug and Antibiotics Expansion.  • Develop the method codes • All of the above

22. Revision of the “QA/QC Guidelines for State Feed Laboratories” • Complete the writing of the document • Present the finished work to the AAFCO Laboratory Methods and Services Committee. • Deal with any needed revisions. • Market the completed work.

23. Sample & Sample Handling Working Group • Developing sampling design for food/feed. • Writing guidance document! • Designing training. • Pilot testing. • Review and modify. • Document mechanisms for improving communications between inspection and laboratory staff.

24. The Volunteers

25. AAFCO Volunteers to APHL Led Activities – Aim 1 • Specific Aim #1: APHL Lead. Design, develop, document, deliver, manage and implement support programs for ISO/IEC 17025:2005 accreditation of food and animal feed regulatory laboratories. Accreditation Work Group: Food and Feed Testing Subcommittee, AAFCO Representatives are: • Josh Arbough, WV Dept. of Ag • Sarah DeDonder, KS Dept. of Ag • Heidi Hickes, MT State U, MT Dept. of Ag • Kristina McCallum, CO Dept. of Ag • Tom Phillips, MD Dept. of Ag • Sarah Snodgrass, WV Dept. of Ag

26. AAFCO Volunteers to APHL Led Activities – Aim 6 • Specific Aim #6: APHL Lead. Provide educational opportunities, resources, tools, and mentoring for laboratories seeking to achieve, maintain, and enhancing the scope of their ISO/IEC 17025:2005 accreditation. Working in concert with IFPTI, expertise will be applied to assess laboratory needs, develop course content, and conduct laboratory training using a multitude of in-person and distance learning. AAFCO representatives to Accreditation Training Steering Committee are: • Brenda Snodgrass, OK Dept. of Ag • Louise Ogden, MN Dept. of Ag • Aaron Price, Canadian Food Inspection Agency • Gale Hagood, MSCL, MSU

27. Volunteers – Aim 2 Sampling and Sample Handling Working Group • Don Burr, FDA CFSAN, FDA Oversight Liaison • Jo Marie Cook, FL Dept. of Ag & Consumer Services • Dan Danielson, TN Dept. of Ag • Qian Graves, FDA CFSAN • Greg Hoffman, Pfizer • Gary Krinke, WI State Lab of Hygiene • Chad Linton, WV Dept. of Ag • Kenneth McManus, MD Dept. of Ag • Edette Newby, FDA CFSAN • Lawrence Novotny, SDSU retired • Chuck Ramsey , EnviroStat • Barb Schroder, MN Dept. of Ag • Thomas Scott, FDA WEAC • YuelianShen, FDA ORA/OGROP • Richard Stephens , FL Dept. of Ag & Consumer Services • Nancy Thiex, Thiex Lab. Solutions • Lynn West, WI State Lab of Hygiene • Ron Willett, NC Dept. of Ag

28. AAFCO Collaborative Check Sample Program – Aim 8 AAFCO Collaborative Check Sample Program Committee and Advisors • Victoria Siegel, Office of the IN State Chemist, Chair • Andy Crawford, Crawford Science • Aaron Price, Canadian Food Inspection Agency • Teresa Grant, NC Dept. of Ag • Mary Koestner, MO Dept. of Ag • Karen Stephani, NY Dept. of Ag and Markets • Mark LeBlanc, LA Dept. of Ag & Forestry • Nancy Thiex, Thiex Lab. Solutions • Dennis McCurdy, FDA CVM • Lars Reimann, Eurofins • Gail DeGreeff, Prince Agri-Products • Christine Atkinson, AOCS • Ken Riter, Nestle Purina • Randall Gordon, NGFA • Jimmie Ward, Proctor & Gamble • Arlene Fox, AOAC • Ravinder Reddy, FDA Oversight Liaison • Don Burr, FDA CFSAN, FDA Oversight Liaison

29. PT Quality Oversight Team – Aim 8 AAFCO Collaborative Check Sample Program Quality Oversight Team • Victoria Siegel, Office of the IN State Chemist, Chair • Andy Crawford, Crawford Science • Aaron Price, Canadian Food Inspection Agency • Brenda Jackson, NC Dept. of Ag • Sharon Webb, UKY, Div. of Regulatory Services • Jimmie Ward, Proctor & Gamble • Tom McKamey, Silliker • Melissa Miller, Covance • Erich Jacobsen, Prince Agri-Products • Gina Clapper, AOCS • Ravinder Reddy, FDA CFSAN, FDA Oversight Liaison • Don Burr, FDA CFSAN, FDA Oversight Liaison

30. Quality GuidelinesVolunteers – Aim 8 Quality Assurance Working Group • Brenda Snodgrass, OK Dept. of Ag, Chair • Louise Ogden, MN Dept. of Ag, Chair • Gale Hagood, MSCL, MSU • Aaron Price, Canadian Food Inspection Agency • Brenda Jackson and Teresa Grant, NC Dept. of Ag • Dennis Givens, Cargill • Nancy Thiex, Thiex Laboratory Solutions • HiteliaCastellanos, FDA ORA OGROP, FDA Oversight Liaison • RuiqingPamboukian, FDA ORA OGROP, FDA Oversight Liaison

31. Volunteers Home Bases

32. Summary • Cooperative Agreement (CoAg) Objectives • Specific Aims & Specific Aims • AAFCO Led Activities • Progress to Date • Upcoming Work • The Volunteers

33. Questions? Thank you!!

34. Questions? Nancy Thiex Nancy.Thiex@gmail.com 605-695-3098