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.
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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.
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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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Guidelines for Validation of Qualitative Binary Chemistry Methods
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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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