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

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

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

Cooperative Agreement Objectives Laboratory accreditation Laboratory accreditation Developing laboratory training programs around accreditation topics. Developing laboratory training programs around accreditation topics. National consensus on the sharing of analytical data 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 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 Expanding a proficiency testing program for feed laboratories Strengthening partnerships with clinical laboratories Strengthening partnerships with clinical laboratories

Cooperative Agreement Specific Aims CoAg has 9 Specific Aims – General areas of work to accomplish broad objectives 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. 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. 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. Each Activity has one of the three associations leading the effort. Volunteers may come from any/all.

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 Collaborative Check Sample Program (CCSP) Committee and Advisors AAFCO Laboratory Methods and Services Committee (LMSC) and Advisors AAFCO Laboratory Methods and Services Committee (LMSC) and Advisors

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

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: Sampling and Sample Handling Working Group administered as a Working Group of: AAFCO Inspection and Sampling Committee AAFCO Inspection and Sampling Committee AAFCO Laboratory Methods and Services Committee and Advisors. AAFCO Laboratory Methods and Services Committee and Advisors.

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. 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 Workgroup Chair: Nancy Thiex

Progress to Date

Accreditation of the AAFCO CCSP to ISO/IEC The Committee is the Working Group. The Committee is the Working Group. Consultant contracts in place. Consultant contracts in place. Face-to-face meetings Jan 22 in Albuquerque, NM 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. 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. Contract in place with FASS to translate the website to code compatible with their site.

Accreditation of the AAFCO CCSP to ISO/IEC QuoData Workshop on Proficiency Testing Data Analysis was attended by Vicki Siegel. 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 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. The Quality Oversight Team is established. A Web Forum for the Quality Oversight Team has been established. A Web Forum for the Quality Oversight Team has been established.

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

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. Method codes for “heavy” metals and mycotoxins have been added to the program. Participants are reporting data. Participants are reporting data. Crawford is using the data to develop approaches to the statistical analysis of residue data. Crawford is using the data to develop approaches to the statistical analysis of residue data. Drug and Antibiotics Expansion. Drug and Antibiotics Expansion.

Revision of the “ QA/QC Guidelines for State Feed Laboratories ” Working Group populated. Working Group populated. Foodshield WorkGroup developed to house documents and facilitate conference call meetings. Foodshield WorkGroup 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. 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. Face-to-face meetings Jan 24 in Albuquerque, NM and February 28 in Oklahoma City, OK. Training Event February in Oklahoma City, OK - ISO/IEC Lead Assessor/Auditor Training Course. Training Event February in Oklahoma City, OK - ISO/IEC Lead Assessor/Auditor Training Course.

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. Consensus on format of deliverable & will include a copy of the ISO/IEC 17025:2005. Work on writing underway. Work on writing underway.

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

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

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

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

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

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

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

The Volunteers

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: 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

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: 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

Volunteers – Aim 2 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 Yuelian Shen, 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 Sampling and Sample Handling Working Group

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

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

Quality Guidelines Volunteers – 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 Hitelia Castellanos, FDA ORA OGROP, FDA Oversight Liaison Ruiqing Pamboukian, FDA ORA OGROP, FDA Oversight Liaison

Volunteers Home Bases

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

Questions? Thank you!!

Questions? Nancy Thiex