2013 ISPAM Mid-Year Mtg Book

International Stakeholder Panel on Alternative Methods (ISPAM) MID-YEAR MEETING Thursday, March 14, 2013 8:30am – 5:00pm

Hilton Washington, DC 1750 Rockville Pike, Rockville, Maryland 20852-1699 United States

Appendix A10.4

AOAC INTERNATIONAL ANTITRUST POLICY STATEMENT AND GUIDELINES

Introduction

It is the policy of AOAC INTERNATIONAL (AOAC) and its members to comply strictly with all laws applicable to AOAC activities. Because AOAC activities frequently involve cooperative undertakings and meetings where competitors may be present, it is important to emphasize the on_going commitment of our members and the Association to full compliance with national and other antitrust laws. This statement is a reminder of that commitment and should be used as a general guide for AOAC and related individual activities and meetings.

Responsibility for Antitrust Compliance

The Association's structure is fashioned and its programs are carried out in conformance with antitrust standards. However, an equal responsibility for antitrust compliance __ which includes avoidance of even an appearance of improper activity __ belongs to the individual. Even the appearance of improper activity must be avoided because the courts have taken the position that actual proof of misconduct is not required under the law. All that is required is whether misconduct can be inferred from the individual's activities. Employers and AOAC depend on individual good judgment to avoid all discussions and activities which may involve improper subject matter and improper procedures. AOAC staff members work conscientiously to avoid subject matter or discussion which may have unintended implications, and counsel for the Association can provide guidance with regard to these matters. It is important for the individual to realize, however, that the competitive significance of a particular conduct or communication probably is evident only to the individual who is directly involved in such matters. In general, the U.S. antitrust laws seek to preserve a free, competitive economy and trade in the United States and in commerce with foreign countries. Laws in other countries have similar objectives. Competitors (including individuals) may not restrain competition among themselves with reference to the price, quality, or distribution of their products, and they may not act in concert to restrict the competitive capabilities or opportunities of competitors, suppliers, or customers. Although the Justice Department and Federal Trade Commission generally enforce the U.S. antitrust laws, private parties can bring their own lawsuits. Penalties for violating the U.S. and other antitrust laws are severe: corporations are subject to heavy fines and injunctive decrees, and may have to pay substantial damage judgments to injured competitors, suppliers, or customers. Individuals are subject to criminal prosecution, and will be punished by fines and imprisonment. Under current U.S. federal sentencing guidelines, individuals found guilty of bid rigging, price fixing, or market allocation must be sent to jail for at least 4 to 10 months and must pay substantial minimum fines. Antitrust Guidelines

AOAC INTERNATIONAL Antitrust Policy Statement and Guidelines Page 2

Since the individual has an important responsibility in ensuring antitrust compliance in AOAC activities, everyone should read and heed the following guidelines.

1. Don't make any effort to bring about or prevent the standardization of any method or product for the purpose or intent of preventing the manufacture or sale of any method or product not conforming to a specified standard. 2. Don't discuss with competitors your own or the competitors' prices, or anything that might affect prices such as costs, discounts, terms of sale, distribution, volume of production, profit margins, territories, or customers.

3. Don't make announcements or statements at AOAC functions, outside leased exhibit space, about your own prices or those of competitors.

4. Don't disclose to others at meetings or otherwise any competitively sensitive information.

5. Don't attempt to use the Association to restrict the economic activities of any firm or any individual.

6. Don't stay at a meeting where any such price or anti_competitive talk occurs.

7. Do conduct all AOAC business meetings in accordance with AOAC rules. These rules require that an AOAC staff member be present or available, the meeting be conducted by a knowledgeable chair, the agenda be followed, and minutes be kept.

8. Do confer with counsel before raising any topic or making any statement with competitive ramifications.

9. Do send copies of meeting minutes and all AOAC_related correspondence to the staff member involved in the activity.

10. Do alert the AOAC staff to any inaccuracies in proposed or existing methods and statements issued, or to be issued, by AOAC and to any conduct not in conformance with these guidelines.

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AOAC INTERNATIONAL Antitrust Policy Statement and Guidelines Page 2

Conclusion

Compliance with these guidelines involves not only avoidance of antitrust violations, but avoidance of any behavior which might be so construed. Bear in mind, however, that the above antitrust laws are stated in general terms, and that this statement is not a summary of applicable laws. It is intended only to highlight and emphasize the principal antitrust standards which are relevant to AOAC programs. You must, therefore, seek the guidance of either AOAC counsel or your own counsel if antitrust questions arise.

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Adopted by the AOAC Board of Directors: September 24, 1989 Revised: March 11, 1991 Revised October 1996

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AOAC INTERNATIONAL POLICY AND PROCEDURES ON VOLUNTEER CONFLICT OF INTEREST

Statement of Policy While it is not the intention of AOAC INTERNATIONAL (AOAC) to restrict the personal, professional, or proprietary activities of AOAC members nor to preclude or restrict participation in Association affairs solely by reason of such activities, it is the sense of AOAC that conflicts of interest or even the appearance of conflicts of interest on the part of AOAC volunteers should be avoided. Where this is not possible or practical under the circumstances, there shall be written disclosure by the volunteers of actual or potential conflicts of interest in order to ensure the credibility and integrity of AOAC. Such written disclosure shall be made to any individual or group within the Association which is reviewing a recommendation which the volunteer had a part in formulating and in which the volunteer has a material interest causing an actual or potential conflict of interest. AOAC requires disclosure of actual or potential conflicts of interest as a condition of active participation in the business of the Association. The burden of disclosure of conflicts of interest or the appearance of conflicts of interest falls upon the volunteer. A disclosed conflict of interest will not in itself bar an AOAC member from participation in Association activities, but a three_fourths majority of the AOAC group reviewing the issue presenting the conflict must concur by secret ballot that the volunteer's continued participation is necessary and will not unreasonably jeopardize the integrity of the decision_making process. Employees of AOAC are governed by the provision of the AOAC policy on conflict of interest by staff. If that policy is in disagreement with or mute on matters covered by this policy, the provisions of this policy shall prevail and apply to staff as well. Illustrations of Conflicts of Interest 1. A volunteer who is serving as a committee member or referee engaged in the evaluation of a method or device; who is also an employee of or receiving a fee from the firm which is manufacturing or distributing the method or device or is an employee of or receiving a fee from a competing firm. 2. A volunteer who is requested to evaluate a proposed method or a related collaborative study in which data are presented that appear detrimental (or favorable) to a product distributed or a position supported by the volunteer's employer.

3. A referee who is conducting a study and evaluating the results of an instrument, a kit, or a piece of equipment which will be provided gratis by the manufacturer or distributor to one or more of the participating laboratories, including his or her own laboratory, at the conclusion of the study. 4. Sponsorship of a collaborative study by an interest (which may include the referee) which stands to profit from the results; such sponsorship usually involving the privilege granted by the investigator to permit the sponsor to review and comment upon the results prior to AOAC evaluation. 5. A volunteer asked to review a manuscript submitted for publication when the manuscript contains information which is critical of a proprietary or other interest of the reviewer. The foregoing are intended as illustrative and should not be interpreted to be all_inclusive examples of conflicts of interest AOAC volunteers may find themselves involved in. Do's and Don't's Do avoid the appearance as well as the fact of a conflict of interest. Do make written disclosure of any material interest which may constitute a conflict of interest or the appearance of a conflict of interest. Do not accept payment or gifts for services rendered as a volunteer of the Association without disclosing such payment or gifts. Do not vote on any issue before an AOAC decision_making body where you have the appearance of or an actual conflict of interest regarding the recommendation or decision before that body. Do not participate in an AOAC decision_making body without written disclosure of actual or potential conflicts of interest in the issues before that body. Do not accept a position of responsibility as an AOAC volunteer, without disclosure, where the discharge of the accepted responsibility will be or may appear to be influenced by proprietary or other conflicting interests. Procedures Each volunteer elected or appointed to an AOAC position of responsibility shall be sent, at the time of election or appointment, a copy of this policy and shall be advised of the requirement to adhere to the provisions herein as a condition for active participation in the business of the Association. Each volunteer, at the time of his or her election or appointment, shall indicate, in writing, on a form provided for this purpose by AOAC, that he or she has read and accepts this policy. Each year, at the spring meeting of the AOAC Board of Directors, the Executive Director shall submit a report certifying the requirements of this policy have been met; including the names and positions of any elected or appointed volunteers who have not at that time indicated in writing that they have accepted the policy.

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AOAC INTERNATIONAL Policy and Procedures on Volunteer Conflict of Interest Page 2

Anyone with knowledge of specific instances in which the provisions of this policy have not been complied with shall report these instances to the Board of Directors, via the Office of the Executive Director, as soon as discovered.

* * * * * *

Adopted: March 2, 1989 Revised: March 28, 1990 Revised: October 1996

International Stakeholder Panel on Alternative Methods

Russell Flowers, Chair Merieux NutriSciences Corporation

Brad Barrett, Member AB SCIEX

Douglas Abbott, Member

Roberto Becerra, Member Poultry And Pork Producers Trade Assosication Of Chile

Michael Abbott, Member Health Canada, Bureau Of Chemical Safety

Gina Bellinger, Member Food Safety Net Services Ltd

James Agin, Member Q Laboratories, Inc.

DeAnn Benesh, Member 3M Food Safety

Laura Allred, Member ELISA Technologies, Inc.

Reginald Bennett, Member US FDA

Neal Apple, Member Tyson Food Safety & Laboratory Services Network

Nega Beru, Member FDA - CFSAN

Patrice Arbault, Member BioAdvantage Consulting

Roy Betts, Member Campden & Chorleywood Food

Marcia Armstrong, Member QIAGEN Gmbh

Lothar Beutin, Member German Food Safety Agency

Arti Arora, Member The Coca-Cola Company

Sneh Bhandari, Member Silliker, Inc.

Stan Bacler, Member Health Canada

Premal Bhatt, Member USP

Stan Bailey, Member BioMerieux, Inc.

Burton Blais, Member Canadian Food Inspection Agency

Lei Bao, Member Shan Dong Import-Export Inspection And Quarantine Bureau Of China

Lou Anne Blanchard, Member Mondelez International

ISPAM March 07, 2013

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Adrian Burns, Member CIPAC - US Representative

Louis Bluhm, Member USDA, LQAD

Christian Blyth, Member 3M Food Safety

Stephanie Campbell, Member Nestle Research Center

Peter Bodnaruk, Member Ecolab Research Center

Richard Cantrill, Member American Oil Chemists Society

Joe Boison, Member Canadian Food Inspection Agency (CFIA)

Claudio Cardelli, Member PCAS - Pacific Coast Analytical Services

Gregory Bone, Member Sensient Colors LLC

Denys Charles, Member Frontier Natural Products Coop.

Robert Brackett, Member IIT

Yi Chen, Member FDA - CFSAN

Edmund Bradford, Member AOAC INTERNATIONAL

Liang Cheng-Zhu, Member Shan Dong Entry-Exit Inspection And Quarantine Bureau

Michael Brodsky, Member Brodsky Consultants

Alejandra Cifuentes, Member LABSER

Philip Bronstein, Member USDA - FSIS

Kristine Clemens, Member Idaho Technology, Inc.

Gerry Broski, Member Neogen Corporation

Scott Coates, Member AOAC INTERNATIONAL

Amy Brown, Member Florida Department Of Agriculture And Consumer Services

Shannon Cole, Member Grocery Manufacturers Association (GMA)

Bob Buchanan, Member Intertaional Commission For The Microbiological Specifications For Food Neither

Axel Colling, Member CSIRO Livestock Industries

Jo Marie Cook, Member Florida Department Of Agriculture And Consumer Services

William Burkhardt, Member FDA, HHS

ISPAM March 07, 2013

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Roger Cook, Member NZ Food Safety Authority (NZFSA)

Benjamin Diep, Member Nestlé

Marie-Pierre Copin, Member 3M Sante

Valentine Digonnet, Member AFNOR Certification

Catherine Costa, Member IDEXX Laboratories Inc

Darrell Donahue, Member University Of Maine Dept. Of Chemical And Biological Engineering

Adam Crossley, Member Pro-Lab Diagnostics Inc.

Rob Donofrio, Member NSF International

Erin Crowley, Member Q Laboratories, Inc.

Donna Douey, Member Canadian Food Inspection

Shenghui Cui, Member

Erin Dreyling, Member Roka Bioscience, Inc.

Puri David, Member Herbal Life Intl

Karl Eckner, Member Norsk Matanalyse -Oslo

Paula De Oliveira, Member Thermo Fisher Scientific

Christopher Elkins, Member FDA - CFSAN

Uday Dessai, Member FSIS USDA

Daniel Engeljohn, Member USDA-FSIS-OPHS

Jonathan DeVries, Member Medallion Laboratories / General Mills

Emilio Esteban, Member USDA FSIS OPHS

Leanne DeWinter, Member Health Canada

Patrick Fach, Member French Food Safety Agency- Anses Paris

Gregory Diachenko, Member FDA/CFSAN

Jeff Farber, Member Hc-Sc-gc-Ca Bureau Of Microbial Hazards

Carmen Diaz-Amigo, Member Eurofins - CTC

Jeffrey Farber, Member Health Canada

Robert Dickey, Member FDA-Gulf Coast Seafood Laboratory

ISPAM March 07, 2013

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Jeff Farrar, Member FDA-HHS

David Gombas, Member United Fresh Produce Association

Max Feinberg, Member INRA

Brad Goskowicz, Member Microbiologics, Inc.

Philip Feldsine, Member BioControl Systems, Inc.

Thomas Grace, Member Bia Diagnostics, LCC

Peter Feng, Member FDA - CFSAN

Thomas Graham, Member Health Canada

Dallam Ferneyhough, Member Kirkegaarde And Perry Laboratories

Rodrigo Granja, Member Microbioticos Laboratories

Richard Fielder, Member ROMER LABS UK Limited

Nuri Gras Rebolledo, Member Chilean Nuclear Energy Commission

Tim Folks, Member Rocky Mountain Diagnostics, Inc.

Qian Graves, Member FDA - CFSAN

Pina Fratamico, Member USDA - ARS - ERRC

Aaron Bone Gregory, Member Sensient Colors LLC

Tong-Jen Fu, Member FDA

Hilary Hagen, Member Tyson

Berengere Genest, Member BioMerieux

Thomas Hammack, Member FDA - CFSAN

Alex Gill, Member Health Canada Food Directurate

Elisabeth Hammer, Member Romer Labs UK

Pamela Gilliland, Member Nestle USA, Inc. Quality Assurance Center

Seth Harkins, Member KPL, Inc.

Samuel Godefroy, Member Health Canada - Food Directorate

James Harnly, Member USDA - ARS BHNRC

David Goldman, Member USDA, FSIS

Gary Hartman, Member FDA

ISPAM March 07, 2013

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Melinda Hayman, Member GMA

Balamurugan Jagadeesan, Member Nestec S.A

Marcus Head, Member USDA - FSIS Food Emergency Response Division

Lee Jaykus, Member North Carolina State University

Stephen Hennart, Member DSM

Robert Jechorek, Member 3M Food Safety

Joshua Hicks, Member Bruker

Ian Jenson, Member Meat & Livestock Australia

Anthony Hitchins, Member FDA-CFSAN (Retired)

Yun Jiang, Member

Kurt Johnson, Member R-Biopharm, Inc.

Jim Hodges, Member American Meat Institute

Ronald Johnson, Member BioMerieux, Inc.

Scott Hood, Member General Mills, Inc.

Keith Jolliff, Member QIAGEN Gmbh

Min Huang, Member Aegis Sciences Corporation

Han Joosten, Member Nestle

James Hungerford, Member FDA - ORA, ATC

George Joseph, Member AsureQuality

Jeffrey Hurst, Member The Hershey Co

Michiru Kakinuma, Member Japan Ministry Of Health, Labor & Welfare (MHLW)

Paul In't Veld, Member Netherlands Food and Consumer Product Safety Authority

Rhonda Kane, Member U.S FDA-CFSAN

Koichi Inoue, Member University Of Shizuoka

Prabhakar Kasturi, Member PepsiCo

Irene Iugovaz, Member Health Canada

Thomas Klebe, Member EPL Bio Analytical Services

Carol Iversen, Member Nestec Ltd.

ISPAM March 07, 2013

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Adrianne Klijn, Member Nestle Quality Assurance Laboratory

Markus Lipp, Member US Pharmacopeia (USP)

Michael Koeris, Member Sample6 Technologies, Inc.

Eric Liu, Member Life Techonolgies

Robert LaBudde, Member Least Cost Formulations, Ltd.

Stephen Lock, Member AB SCIEX

Marcus Lacorn, Member R-Biopharm AG

Bertrand Lombard, Member ANSES

Roxane Lafortune, Member BioMerieux

Guy Loneragan, Member Texas Tech University (TTU)

Martha Lamont, Member AMS USDA

Devin Lu, Member 3M China Ltd

Wendy Lauer, Member Bio-Rad Laboratories

Anthony Lupo, Member Neogen Corporation

Kristie Laurvick, Member US Pharmacopeia (USP)

Roy Macarthur, Member The Food And Environment Research Agency

Randal Layton, Member USDA - FSIS-OPHS

Harry Marks, Member USDA - FSIS

Barbara Lee, Member Health Canada, Bureau Of Chemical Safety

Nora Marshall, Member AOAC Research Institute

Zhiayong Li, Member Guangdong Entry-Exit Inspection & Quarantine Bureau

Emily Mathusa, Member GMA

Timothy McGrath, Member FDA

Jun Liang, Member CNCA

Krystyna McIver, Member AOAC INTERNATIONAL

Kathryn G Lindberg, Member

Shih-Chuan Liou, Member F&HC MCO

Deborah McKenzie, Member AOAC INTERNATIONAL

ISPAM March 07, 2013

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Michael McLaughlin, Member FDA - ORA/DFS

Dan Morse, Member 3M Food Safety

Adrienne McMahon, Member Wyeth Nutrition - Ireland

Julie Moulin, Member Nestec S.A.

Wendy McMahon, Member Silliker Inc.

Laura Mout, Member NEN

Patricia Meinhardt, Member R-Biopharm Inc.

Mark Mozola, Member Neogen Corporation

Carla Mejia, Member US Pharmacopeia (USP)

Jun Mu, Member

Brian Murphy, Member Waters Corp

Magdalena Michulec, Member Nestle Research Center

Steven Musser, Member FDA - CFSAN

Jesse Miller, Member 3M Microbiology Products

Hiroyuki Nakagawa, Member National Agriculture and Food Research Organization

John Mills, Member BioMerieux, Inc.

Nandini Natrajan, Member Keystone Foods

Sam Mohajer, Member Canadian Food Inspection Agency

Kendra Nightingale, Member Texas Tech University

Alfredo Montes-Nino, Member Microbioticos Labs

Hilde Norli, Member NMKL

Kirsten Mooijman, Member

Jeffrey Moore, Member US Pharmacopeia (USP)

Michael Norman, Member Phenomenex

Amit Morey, Member Food Safety Net Services

Jeffrey Nunez, Member Micro-Imaging Technologies

Jayne Morrow, Member NIST

Palmer Orlandi, Member FDA - Food Emergency Response Network, National Program Office

ISPAM March 07, 2013

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Franco Pagotto, Member Health Canada - HPFB - Bureau Of Microbial

J.O. Reagan, Member National Cattlemen's Beef Association

Daryl Paulson, Member BioScience Laboratories Inc.

Ravinder Reddy, Member FDA - CFSAN

Tory Peeler, Member BD Diagnostics

Lars Reimann, Member Eurofins Scientific, Inc.

Luis Pelayo, Member Micro Imaging Technologies

Todd Ritter, Member Bio-Surveillance Solutions

Linda Peng, Member DuPont Qualicon

James Roberts, Member National Measurement Institute

Cathy Pentz, Member USDA - FSIS, OPHS, Laboratory QA Division

Alejandro Rojas, Member 3M Food Safety

Ruth Petran, Member Ecolab

Mark Ross, Member FDA - CFSAN

Tom Phillips, Member MD Department Of Agriculture

Christine Rozand, Member BioMerieux, Inc.

Jerri Pickett, Member Tyson Food Safety & Research Lab

Elisa Ruiz, Member Life Technologies

Jean-Louis Pittet, Member BioMerieux,S.A.

Yvonne Salfinger, Member

Robert Salter, Member Charm Sciences Incorporated

Charles Pixley, Member USDA - FSIS

Stephanie Sammartano, Member AFNOR

Bert Popping, Member Eurofins Scientific Group

Brian Schaneberg, Member Starbucks

Michael Prinster, Member Romer Labs, Inc.

Flemming Scheutz, Member SSI - Copenhagen

Robert Rae, Member Pro-Lab Diagnositcs, Inc.

ISPAM March 07, 2013

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Karen Schimpf, Member Abbott Laboratories

Bradley Stawick, Member Microbac Laboratories, Inc.

Jean Schoeni, Member Covance Labs

Morabito Stefano, Member Italian Veterinary Public Health & Food Saftey Department

Florian Schweigert, Member

Henk Stegeman, Member MicroVal

Carl Sciacchitano, Member FDA - ORA

Kelly Stevens, Member General Mills

Weilin Shelver, Member USDA, ARS, Biosciences Research Laboratory

Appavu Sundaram, Member Science & Engineering Services, Inc.

Gordon Shephard, Member South African Medical Research Council

Tomomichi Suzuki, Member Tokyo University of Science

Neil Shepherd, Member National Association of Testing Authorities

John Szpylka, Member Silliker Laboratories

Raymond Shillito, Member Bayer CropScience

Shaobing Tang, Member

Fu Shishan, Member

Robert Tebbs, Member Applied Biosystems/Life Technologies

Mustafa Simmons, Member USDA - FSIS, OPHS, MD

Brian Teeter, Member

Robert Sinclair, Member Barratt & Smith Pathology

Nancy Thiex, Member Thiex Laboratory Solutions LLC

David Slaughter, Member University Of California - Davis

Daniel Tholen, Member Dan Tholen Statistical Consulting

Christopher Snabes, Member American Proficiency Institute

Caryn Thompson, Member Elanco Animal Health

Daniele Sohier, Member ADRIA

Leslie Thompson, Member AEGIS Food Testing Laboratory

ISPAM March 07, 2013

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Glenn Tillman, Member USDA - FSIS, OPHS, MD

Christoph Von Holst, Member DG Joint Rees Centre European Institute For Reference Materials & Measurements

Laszlo Torma, Member Pickering Laboratories, Inc.

Travis Waldron, Member Idexx Food Safety Net Services Inc

Suzanne Tortorelli, Member Campbell Soup Residue Lab

Morgan Wallace, Member DuPont Qualicon

Mary Tortorello, Member National Center For Food Safety And Technology

Lindell Ward, Member Elanco / Eli Lilly & Co.

Yvon-Louis Trottier, Member Health Canada Food Directorate

Peter Wareing, Member Leatherhead Food Research

Mary Trucksess, Member US FDA (Retired)

Lisa Weddig, Member National Fisheries Institute

Socrates Trujillo, Member US FDA - Office Of Food Safety

Paul Wehling, Member General Mills, Inc.

Mika Tuomola, Member Raisio Diagnostics OY

Scott Welsh, Member Ben Franklin Technology Partners

Franz Ulberth, Member European Commission

Timothy Wheeler, Member BioMerieux, Inc.

Peter Unger, Member A2LA - American Association For Laboratory Accreditation

Robert Wiebe, Member Maxxam

Hilko Van Der Voet, Member Wageningen UR University & Research Centre

Pamela Wilger, Member Cargill

Purnendu Vasavada, Member University Of Wisconsin, River Falls

Peter Wilrich, Member Freie Universitat Berlin

Steve Vaughn, Member FDA HHS

Craig Wilson, Member Costco

Orialis Villaroel, Member Instituto De Salud Publica

Michele Wisniewski, Member Roka Bioscience

ISPAM March 07, 2013

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Wayne Wolf, Member USDA (Retired)

Danilo Lo Fo Wong, Member World Health Organization

Tamara Wood, Member Cargill

Huang Xiaorong, Member Fujian-Exit Inspection & Quarantine Bureau

Dajin Yang, Member

Fang Yang, Member Fujian Entry-Exit Inspection And Quarantine Bureau

Ren Yiping, Member Zhejiang Provincial Center For Disease Prevention & Control

Netty Zegers, Member MicroVal NEN

Daniel Zelenka, Member Tyson Foods, INC

Rui Zhang, Member Rui Zhang

Wenjie Zheng, Member

Donald Zink, Member FDA

ISPAM March 07, 2013

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ISPAM Subgroup All Foods Claim

Michael Brodsky, Chair Brodsky Consultants

Russell Flowers, Member Merieux NutriSciences Corporation

Douglas Abbott, Member

Thomas Hammack, Member FDA - CFSAN

James Agin, Member Q Laboratories, Inc.

Paul In't Veld, Member Netherlands Food and Consumer Product Safety Authority

Patrice Arbault, Member BioAdvantage Consulting

Irene Iugovaz, Member Health Canada

DeAnn Benesh, Member 3M Food Safety

Balamurugan Jagadeesan, Member Nestec S.A

Philip Bronstein, Member USDA - FSIS

Ronald Johnson, Member BioMerieux, Inc.

William Burkhardt, Member FDA, HHS

Wendy Lauer, Member Bio-Rad Laboratories, Inc.

Yi Chen, Member FDA - CFSAN

Bertrand Lombard, Member ANSES

Victor Cook, Member USDA, FSIS, OPHS, Microbiology Division

Shelagh McDonagh, Member Canadian Food Inspection Agency

Benjamin Diep, Member Nestlé

Sam Mohajer, Member Canadian Food Inspection Agency

Christopher Elkins, Member FDA - CFSAN

Julie Moulin, Member Nestec S.A.

Philip Feldsine, Member BioControl Systems, Inc.

Mark Mozola, Member Neogen Corporation

ISPAM_SGALL March 07, 2013

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Nandini Natrajan, Member Keystone Foods

Palmer Orlandi, Member FDA - Food Emergency Response Network, National Program Office

Ravinder Reddy, Member FDA - CFSAN

Yvonne Salfinger, Member

Daniele Sohier, Member ADRIA

Bradley Stawick, Member Microbac Laboratories, Inc.

Henk Stegeman, Member MicroVal

Darryl Sullivan, Member Covance Laboratories

Leslie Thompson, Member *USE ID 106555

Morgan Wallace, Member DuPont Qualicon

Paul Wehling, Member General Mills, Inc.

Pamela Wilger, Member Cargill

ISPAM_SGALL March 07, 2013

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ISPAM ISO Revisions Salmonella

Patrice Arbault, Chair BioAdvantage Consulting

Irene Iugovaz, Member Health Canada

James Agin, Member Q Laboratories, Inc.

Balamurugan Jagadeesan, Member Nestec S.A

DeAnn Benesh, Member 3M Food Safety

Ronald Johnson, Member BioMerieux, Inc.

Michael Brodsky, Member Brodsky Consultants

Adrianne Klijn, Member Nestle Quality Assurance Laboratory

Philip Bronstein, Member USDA - FSIS

Bertrand Lombard, Member ANSES

Yi Chen, Member FDA - CFSAN

Sam Mohajer, Member Canadian Food Inspection Agency

Leanne DeWinter, Member Health Canada

Kirsten Mooijman, Member

Julie Moulin, Member Nestec S.A.

Benjamin Diep, Member Nestlé

Nandini Natrajan, Member Keystone Foods

Christopher Elkins, Member FDA - CFSAN

Palmer Orlandi, Member FDA - Food Emergency Response Network, National Program Office

Philip Feldsine, Member BioControl Systems, Inc.

Bradley Stawick, Member Microbac Laboratories, Inc.

Thomas Hammack, Member FDA - CFSAN

Leslie Thompson, Member *USE ID 106555

Seth Harkins, Member KPL, Inc.

ISPAM_ISOSALM March 07, 2013

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Morgan Wallace, Member Dupont Qualicon

Pamela Wilger, Member Cargill

ISPAM_ISOSALM March 07, 2013

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ISPAM Micro Working Group

Russell Flowers, Chair Merieux NutriSciences Corporation

Kristine Clemens, Member Idaho Technology, Inc.

Douglas Abbott, Member

Victor Cook, Member USDA, FSIS, OPHS, Microbiology Division

James Agin, Member Q Laboratories, Inc.

Leanne DeWinter, Member Health Canada

Patrice Arbault, Member BioAdvantage Consulting

Benjamin Diep, Member Nestlé

Stan Bacler, Member Health Canada

Valentine Digonnet, Member AFNOR Certification

DeAnn Benesh, Member 3M Food Safety

Donna Douey, Member Canadian Food Inspection

Roy Betts, Member Campden & Chorleywood Food

Erin Dreyling, Member Roka Bioscience, Inc.

Lou Anne Blanchard, Member Mondelez International

Christopher Elkins, Member FDA - CFSAN

Michael Brodsky, Member Brodsky Consultants

Peter Evans, Member USDA FSIS

Philip Bronstein, Member USDA - FSIS

Max Feinberg, Member INRA

Stephanie Campbell, Member Nestle Research Center

Philip Feldsine, Member BioControl Systems, Inc.

Yi Chen, Member FDA - CFSAN

Peter Feng, Member FDA - CFSAN

ISPAM_MICRO March 07, 2013

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David Goldman, Member USDA, FSIS

Adrianne Klijn, Member Nestle Quality Assurance Laboratory

Nuri Gras Rebolledo, Member Chilean Nuclear Energy Commission

Robert LaBudde, Member Least Cost Formulations, Ltd.

Qian Graves, Member FDA - CFSAN

Wendy Lauer, Member Bio-Rad Laboratories

Thomas Hammack, Member FDA - CFSAN

Eric Liu, Member Life Techonolgies

Seth Harkins, Member KPL, Inc.

Bertrand Lombard, Member ANSES

Gary Hartman, Member FDA

Harry Marks, Member USDA - FSIS

Marcus Head, Member USDA - FSIS Food Emergency Response Division

Shelagh McDonagh, Member Canadian Food Inspection Agency

Rien Huige, Member NEN Food And Agriculture

Sam Mohajer, Member Canadian Food Inspection Agency

Paul In't Veld, Member Netherlands Food and Consumer Product Safety Authority

Kirsten Mooijman, Member

Jayne Morrow, Member NIST

Irene Iugovaz, Member Health Canada

Julie Moulin, Member Nestec S.A.

Carol Iverson, Member Institute For Food Safety And Hygiene

Mark Mozola, Member Neogen Corporation

Balamurugan Jagadeesan, Member Nestec S.A

Nandini Natrajan, Member Keystone Foods

Ronald Johnson, Member BioMerieux, Inc.

Palmer Orlandi, Member FDA - Food Emergency Response Network, National Program Office

Han Joosten, Member Nestle

ISPAM_MICRO March 07, 2013

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Cathy Pentz, Member USDA - FSIS, OPHS, Laboratory QA Division

Netty Zegers, Member MicroVal NEN

Ravinder Reddy, Member FDA - CFSAN

Elisa Ruiz, Member Life Technologies

Yvonne Salfinger, Member

Daniele Sohier, Member ADRIA

Bradley Stawick, Member Microbac Laboratories, Inc.

Henk Stegeman, Member MicroVal

John Szpylka, Member Silliker Laboratories

Daniel Tholen, Member Dan Tholen Statistical Consulting

Caryn Thompson, Member Elanco Animal Health

Leslie Thompson, Member AEGIS Food Testing Laboratory

Morgan Wallace, Member Dupont Qualicon

Paul Wehling, Member General Mills, Inc.

Pamela Wilger, Member Cargill

ISPAM_MICRO March 07, 2013

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ISPAM_MICRO March 07, 2013

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ISPAM Qualitivative Chemistry

Bert Popping, Chair Eurofins Scientific Group

Richard Fielder, Member ROMER LABS UK Limited

Laura Allred, Member ELISA Technologies, Inc.

Russell Flowers, Member Merieux NutriSciences Corporation

Stan Bacler, Member Health Canada

Timothy Folks, Member Rocky Mountain Diagnostics, Inc.

Brad Barrett, Member AB SCIEX

Samuel Godefroy, Member Health Canada - Food Directorate

Joe Boison, Member Canadian Food Inspection Agency (CFIA)

Thomas Grace, Member Bia Diagnostics, LCC

Adrian Burns, Member CIPAC - US Representative

Qian Graves, Member FDA - CFSAN

Richard Cantrill, Member American Oil Chemists Society

Elisabeth Hammer, Member Romer Labs UK

Mark Coleman, Member Elanco Animal Health

Stephen Hennart, Member DSM

Jo Marie Cook, Member Florida Department Of Agriculture And Consumer Services

Anthony Hitchins, Member FDA-CFSAN (Retired)

Paul In't Veld, Member Netherlands Food and Consumer Product Safety Authority

Catherine Costa, Member IDEXX Laboratories Inc

Jacqueline Coutts, Member Tepnel Life Sciences PLC Tepnel BioSystems, Ltd

Kurt Johnson, Member R-Biopharm, Inc.

Rhonda Kane, Member U.S FDA-CFSAN

Max Feinberg, Member INRA

ISPAM_QUAL March 07, 2013

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Marcus Lacorn, Member R-Biopharm AG

Gordon Shephard, Member South African Medical Research Council

Barbara Lee, Member Health Canada, Bureau Of Chemical Safety

Raymond Shillito, Member Bayer CropScience

Stephen Lock, Member AB SCIEX

Tomomichi Suzuki, Member Tokyo University of Science

Anthony Lupo, Member Neogen Corporation

John Szpylka, Member Silliker Laboratories

Roy Macarthur, Member The Food And Environment Research Agency

Brian Teeter, Member

Daniel Tholen, Member Dan Tholen Statistical Consulting

Harry Marks, Member USDA - FSIS

Caryn Thompson, Member Elanco Animal Health

Michael McLaughlin, Member FDA - ORA/DFS

Mika Tuomola, Member Raisio Diagnostics OY

Patricia Meinhardt, Member R-Biopharm Inc.

Christoph Von Holst, Member DG Joint Rees Centre European Institute For Reference Materials & Measurements

Magdalena Michulec, Member Nestle Research Center

Travis Waldron, Member Idexx Food Safety Net Services Inc

Julie Moulin, Member Nestec S.A.

Lindell Ward, Member Elanco / Eli Lilly & Co.

Jean-Louis Pittet, Member BioMerieux,S.A.

Paul Wehling, Member General Mills, Inc.

Lars Reimann, Member Eurofins Scientific, Inc.

Peter Wilrich, Member Freie Universitat Berlin

Mark Ross, Member FDA - CFSAN

Wayne Wolf, Member USDA (Retired)

Robert Salter, Member Charm Sciences Incorporated

ISPAM_QUAL March 07, 2013

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Meeting of the International Stakeholder Panel on Alternative Methods (ISPAM) and Working Groups DRAFT AGENDA Thursday, March 14, 2013 8:30 am – 5:00 pm Plaza 1 & 2 HILTON WASHINGTON D.C./ROCKVILLE EXECUTIVE MEETING CENTER ISPAM JOINT SESSION (Plaza 1 & 2) (8:30 am – 9:30 am) A. Welcome and Introductions – Russ Flowers, Mérieux NutriSciences & Chair, ISPAM B. Overview of ISPAM Goals, Accomplishments to Date, and Meeting Goals – Russ Flowers, Mérieux NutriSciences and Chair, ISPAM C. Discussion and Vote on Guidelines for Validation of Qualitative Chemistry Methods by ISPAM voting members – Joe Boison, CFIA and Acting Chair WG on Qualitative Chemistry Guidelines * Version 12.3 of the Guidelines will be presented for final approval by ISPAM. The Guidelines have undergone public comment period, and additional revisions based on the comments by the Working Group. A report will be given as to how the Guidelines will be presented to CCMAS, MoniQA and ISO for acceptance or incorporation into their respective standards/guidelines. II. ISPAM Sub-group Meeting on Harmonization of Verification Guidelines for “All Foods” Claims – Michael Brodsky, Brodsky Consultants and Chair, “All Foods” Sub-group ** (9: ISPAM for vote on the “all foods” claim. * The group will also discuss the Draft ISO Standard, “Microbiology of food and animal feed – Method validation Part 4: Protocol for verification of reference and alternative methods implemented in a single laboratory using validated or non-validated matrices.” This draft will be compared to other method verification procedures. The intent is to make recommendations to the ISO I.

Registration Opens at 7:30 am

committee charged with drafting the standard so that it becomes an internationally harmonized method.

Lunch Break – 11:45am – 12:30 pm

III. Discussion on recommendations for revision of ISO Method 6579 on Salmonella – Patrice Arbault, BioAdvantage, and Chair, Sub-group on Revision of ISO Method 6579 on Salmonella; Roy Betts, Campden BRI and Vice-Chair; Donna Douey, CFIA (12:30 pm – 2:45 pm) ** At the September 2012 meeting, ISPAM created a WG to develop recommendations for the revision of ISO Method 6579 on salmonella with the goal of harmonizing the method with other methods for salmonella. The group will compare multiple methods on salmonella to identify differences and areas for harmonization. IV. Meeting of the Fresh Produce Steering Committee – Brooke Schwartz, Brooke Schwartz Consulting (3:00pm – 5:00 pm ) * * AOAC INTERNATONAL has made produce safety a high priority. The AOAC Board of Directors approved an AOAC Research Institute proposed budget to engage the fresh produce supply chain industry to help provide food safety standards for fresh produce production and handling. The Fresh Produce Steering Committee will discuss analytical issues in the fresh produce arena, set project goals and priorities, and identify key stakeholders from government, supply chain industry, organizations representing the industry, and test kit manufacturers who would be part of a large stakeholder panel that would execute the work.

ADJOURN

*

Action Items for ISPAM vote

** This meeting is open to the entire Stakeholder Panel. Action items will be voted on by ISPAM and all are encouraged to participate.

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Meeting of the International Stakeholder Panel on Alternative Methods (ISPAM) and Working Groups March 14, 2012 Rockville, MD Russ Flowers – Mérieux NutriSciences

Overview  Driven and supported by AOAC Organizational Affiliates and contributing members who participate in the AOAC Research Institute Program  Purpose and Scope  Develop harmonized, internationally accepted standard validation guidelines for alternative chemical and i bi l i l h d b l i l b l k f m cro o og ca met o s y everag ng g o a networ s o experts to reach consensus on an analytical validation protocol

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ISPAM

 Formation of the International Stakeholder Panel on Alternative Methods (ISPAM) S i b d d l f  c ence- ase , open an neutra orum  60+ scientific and technical experts from around the world  Industry, academia, government and organizations  Only 20 – 25 have voting power  Need for balanced group from the different organizations, sectors, and countries  Approve scope of work, direction of the work groups and discuss/modify/approve recommendations

ISPAM Working Groups

 ThreeWorking Groups of subject matter experts formed  WG on Microbiological Guidelines  WG on Qualitative Chemistry Guidelines  WG on Statistics  Role ofWGs  Set priorities  Identify priority areas to reach harmonization  Propose solutions

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ISPAM History

 November 29, 2010  AOAC Research Board endorsed supporting a stakeholder panel to work on harmonizing validation guidelines for alternative methods.  December, 2010  AOAC Board of Directors approves establishing an Advisory Panel to define the project  March 15, 2011  Advisory Panel meets to define the project and recommends experts for Stakeholder Panel and Working Groups  April 12, 2011  Review of potential Panel andWorking Group members

ISPAM History

 September 29, 2012

 ChemistryWorking Group –  Developed guidelines for validation of qualitative chemistry  Proposed guidelines be circulated to broader group  Microbiology working group –  Accepted the Food Category Table  Discuss alternatives for validating the equivalency of reference methods  Organize a working group to discuss MethodVerification related to All Foods Claim  Create an ISPAMWG to develop recommendations to the revision of ISO 6579 on Salmonella  Voted to discontinue work on E. coli STEC

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Table of Contents

1.0 Scope 2.0 Terms and Definitions 3.0 Selectivity Study 4 .0 Collaborative Study 5.0

Matrix and POD Concentration Study

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1.0 Scope The purpose of this document is to provide a guideline for the validation of binary 1 qualitative methods intended to detect biological and chemical compounds. Qualitative methods that are used to make a detection decision by comparing the value of a response to a cut-off value should be validated by using quantitative statistics, where possible, on the responses 2 . 2.0 Terms and Definitions Where appropriate, definitions have been taken from international standards and the source is noted. Sources of definitions include the following: ISO/IEC Guide 99:2007, International vocabulary of metrology – Basic and general concepts and associated terms (VIM) ISO 3534-2:2006, Statistics – Vocabulary and symbols – Part 2: Applied statistics ISO 14971:2007, Medical devices – Application of risk management to medical devices ISO 17511:2003, In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials ISO 5725-1: 1994, Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions USP 31:2008, US Pharmacopeia General Information/<1223> Validation of Alternative Microbiological Methods Candidate Method The method submitted for validation. Matrix Totality of components of a material system except the analyte (ISO 17511). Method A procedure that includes sample processing, assay, and data interpretation. Probability of Detection (POD) The proportion of positive analytical outcomes for a qualitative method for a given matrix at a given analyte level or concentration. POD is concentration dependent. 1 A binary qualitative method is one that produces one out of two possible responses when it is used (e.g., end time PCR, visual inspection of a dip stick). 2 The use of quantitative statistics usually gives better estimates of method performance for fewer replicate analyses in each laboratory.

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Qualitative Binary Method A method of analysis with two possible outcomes. Reproducibility Precision under reproducibility conditions (ISO 5725-1). Reproducibility Conditions

Conditions where test results are obtained with the same method on identical test material in different laboratories with different operators using different equipment. Sample A small portion or quantity taken from a population or lot that is ideally a representative selection of the whole. Samples are taken from lots for purposes of scientific examination and analysis and are intended to provide characteristic information about the population, generally by applying statistical calculations. Source: ISO 3534-1:1993 Laboratory sample Sample as prepared for sending to the laboratory and intended for inspection or testing. Source: ISO 7002:1986 Test portion A fraction of a sample intended for analysis. There are cases (liquid products, analysis of symptoms, etc.) where the laboratory sample is also the test sample. Source: ISO 21572. 3.0 Selectivity Study The selectivity study is a single laboratory study designed to demonstrate that a method does not detect non-target compounds, and at the same time demonstrate a candidate method’s ability to detect the related compounds. 3.1. Organize a “selectivity” test panel of related compounds that are expected to give a positive result. Document the source and origin of each test panel compound. All documentation of the analyte identity must be on file and available for review. 3.2. Organize a panel of non-target compounds that might be expected to be encountered when the method is used; or to be erroneously detected by virtue of chemical or other similarities. 3.3. Prepare at least one replicate of each target compound from the selectivity test panel at the 95% POD concentration. Prepare at least one replicate of each non-target compound from the selectivity test panel at an appropriate concentration. Blind code and randomly mix the selectivity and non-target compounds.

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3.4. An analyst (or analysts) not involved in the preparation of the test panel shall evaluate the compounds using the candidate method and record the results. 3.5. If an individual test panel compound yields an incorrect result (a negative in the case of a target compound; a positive in the case of a non-target compound) then the compound may be retested with a number of replicates to be determined by subject matter experts. The number of replicates will determine the lower confidence interval for the POD estimate. 4.0 Matrix and POD Concentration Study The matrix study is a single-laboratory study designed to demonstrate that a candidate method can detect the target compound in the claimed matrixes. Analyze test portions of the claimed matrices containing the target compound(s) at various concentrations. The number of different matrices to be tested depends on the claims and intended use of the method. In general, a minimum of 5 concentrations per target compound should be evaluated for each matrix, but more concentrations could be included at the discretion of subject matter experts. The number of replicates at each concentration should be determined by the subject matter expert(s). The number of replicates at the 95% POD concentration may be greater than at other concentrations. For example, the 95% POD concentration may have 96 replicates while other concentrations only 4. A more balanced approach would spread replicates across all concentrations, with a minimum of 20 replicates at each of 5 concentrations. Some discretion is allowed with consultation by a statistician. For example, if more than 5 concentrations are desired, the number of replicates per concentration could be reduced. The decisions on number of replicates should be made with an understanding of the desired level of confidence in the final results. 4.1. Incurred or Fortified : A target compound in a matrix may be incurred or fortified. Incurred target compound(s) are preferred. If not available, matrix fortified with the target compound(s) may be used. If a matrix with incurred target compound(s) is used, then matrix that is known to be free of the target compound(s) can be used to ‘dilute’ it to the desired concentration. Evidence supporting homogeneity must be provided. 4.2. Raw and/or processed materials: Both processed (e.g. such as cooked, fermented, etc.) and raw samples should be represented if the assay claims to detect the target compound(s) in such foods. If the method detects more than one target compound simultaneously in

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the same test portion, the study should be designed so that the target compounds are fortified together into some of the test portions. Collect enough of each matrix to prepare more than the required number of test portions for each concentration. Prepare the required number of test portions of the matrix with the target compound(s) at the specified concentration. Blind-code, randomize, and analyze the prepared test portions. The analyst performing the analyses should not have knowledge of the study design or the blind-codes of the test portions. The analyst should be informed that the design of the study does include a certain number of “blank” samples and that both positive and negative outcomes should be expected. Plot the response of the method as POD response vs. concentration of target compound(s). 4.3. Statistical Analysis: Refer to Annex 1 for guidance on statistical analysis of data. 5.0 Collaborative Study A Collaborative Study characterizes the performance parameters (e.g., POD, repeatability, reproducibility) of the candidate method across testing sites. Methods shall be validated under conditions of intended use. For example, a method intended for use by trained factory operators at a grain inspection site must be validated under conditions that simulate the grain inspection site and should include representative end users as collaborators. A collaborative study must include a minimum of 10 testing sites, each reporting at least 6 valid replicate analyses per concentration. See Annex 2 for recommendations on the range and number of concentrations, and the number of replicates for each concentration. Deviations from these recommendations must be documented and justified. Study test portions must be blind-coded and shipped to each collaborator. Collaborators shall perform all analyses independently. If the method detects more than one target compound simultaneously in the same test portion, the study should be designed so that the target compounds are fortified together into some of the test portions.

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