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

The AAFCO PerspectiveNancy Thiex, AAFCO Lead Investigator and AAFCO Cooperative

Agreement Administrator

Overview

Cooperative Agreement (CoAg) ObjectivesSpecific Aims & Specific AimsAAFCO Led ActivitiesProgress to Date Upcoming WorkThe VolunteersQuestions

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

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.

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

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)

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.

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

Progress to Date

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.

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.

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.

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. 

Revision of the “QA/QC Guidelines for State Feed

Laboratories” Working Group populated. 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. 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.

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.

Sample & Sample Handling Working

Group Working Group populated. Consultant contract in place. Biweekly conference calls held Foodshield WorkGroup developed 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

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.

What’s Next –

Getting our ducks in a row!!

Accreditation of the AAFCO CCSP to ISO/IEC 17043

Complete the Quality ManualReview 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 BodyAssessment by the Accreditation Body

Expansion of the Scope of the AAFCO CCSP PT

Residue Detection Program.Develop the residue statistical approachComplete the necessary programming and

website modificationsDevelop the reportPurchase spiked feed materials for the program

Drug and Antibiotics Expansion. Develop the method codesAll of the above

Revision of the “QA/QC Guidelines for State Feed

Laboratories” Complete the writing of the documentPresent the finished work to the AAFCO

Laboratory Methods and Services Committee.Deal with any needed revisions.Market the completed work.

Sample & Sample Handling Working

GroupDeveloping 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.

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:

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:

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 LiaisonJo Marie Cook, FL Dept. of Ag & Consumer ServicesDan Danielson, TN Dept. of AgQian Graves, FDA CFSANGreg Hoffman, PfizerGary Krinke, WI State Lab of HygieneChad Linton, WV Dept. of AgKenneth McManus, MD Dept. of AgEdette Newby, FDA CFSAN

Lawrence Novotny, SDSU retiredChuck Ramsey , EnviroStatBarb Schroder, MN Dept. of AgThomas Scott, FDA WEACYuelian Shen, FDA ORA/OGROPRichard Stephens , FL Dept. of Ag & Consumer ServicesNancy Thiex, Thiex Lab. SolutionsLynn West, WI State Lab of HygieneRon Willett, NC Dept. of Ag

Sampling and Sample Handling Working Group

AAFCO Collaborative Check Sample Program –

Aim 8AAFCO 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 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 Hitelia Castellanos, FDA ORA OGROP, FDA Oversight

Liaison Ruiqing Pamboukian, FDA ORA OGROP, FDA Oversight

Liaison

Volunteers Home Bases

Summary

Cooperative Agreement (CoAg) ObjectivesSpecific Aims & Specific AimsAAFCO Led ActivitiesProgress to Date Upcoming WorkThe Volunteers

Questions?

Thank you!!

Questions?

Nancy ThiexNancy.Thiex@gmail.com

605-695-3098