The First Meeting of the

AOAC Stakeholder Panel for

Strategic Food Analytical Methods

Rockville, Maryland, USA Thursday June 30, 2011

AOAC INTERNATIONAL 481 N. Frederick Avenue, Suite 500

Gaithersburg, MD 20876 United States

dfrazier@aoac.org & mjones@aoac.org 301.924.7077 ext. 117 & 301.924.7077 ext 114

Table of Contents

I. Preliminary Information ....................................................................................................................

1. Policy Documents .............................................................................................................

II. Rosters ..............................................................................................................................................

2. Advisory Panel and Working Group Roster .....................................................................

3. SPSFAM Roster ................................................................................................................

4. SPSFAM Voting Members Roster .....................................................................................

5. Board of Directors Roster ................................................................................................

6. AOAC Staff Roster ............................................................................................................

III. Chair and Co-Chair Bios .....................................................................................................................

7. Arti Arora Bio ...................................................................................................................

8. LouAnne Blanchard Bio ....................................................................................................

9. Brian Schaneberg Bio .......................................................................................................

10. Markus Lipp Bio ................................................................................................................

11. John Austad Bio…………………………………………………………………………………………………………..

IV. SPSFAM Presentations and Working Group Proposals .......................................................................

12. SPSFAM Agenda ...............................................................................................................

13. Antioxidants – Arti Arora, LouAnne Blanchard and Brian Schaneberg ............................

14. Flavonoids – Arti Arora and Brian Schaneberg ................................................................

15. Contaminants – Markus Lipp and LouAnne Blanchard ....................................................

16. Modernized Methods for Raw Ingredients – John Austad ..............................................

V. Future Meetings ................................................................................................................................

17. Save the Date Flyer ..........................................................................................................

18. Why Attend the 125th AOAC Annual Meeting .................................................................

19. 2011 Annual Meeting Schedule At A Glance ...................................................................

20. 2011 Meeting Registration

21. AOAC INTERNATIONAL Sections – Get Involved ..............................................................

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Standards Development and International Harmonization AOAC INTERNATIONAL Mid-Year Meeting

Stakeholder Panel for Strategic Food Analytical Methods (SPSFAM)

STAKEHOLDER MEETING

Meeting at Hilton Washington DC/Rockville Hotel & Meeting Conference Center

Rockville, Maryland USA

Thursday, June 30, 2011

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Item 1-1b Policy on Antitrust

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.

Antitrust Guidelines 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.

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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. 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.

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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.

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.

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

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AOAC INTERNATIONAL POLICY ON THE USE OF THE

ASSOCIATION NAME, INITIALS, IDENTIFYING INSIGNIA, LETTERHEAD, AND BUSINESS CARDS

Introduction The following policy and guidelines for the use of the name, initials, and other identifying insignia of AOAC INTERNATIONAL have been developed in order to protect the reputation, image, legal integrity and property of the Association. The name of the Association, as stated in its bylaws, is "AOAC INTERNATIONAL". The Association is also known by its initials, AOAC, and by its logo, illustrated below, which incorporates the Association name and a representation of a microscope, book, and flask. The AOAC logo is owned by the Association and is registered with the U.S. Patent and Trademark Office.

The full Association insignia, illustrated below, is comprised of the logo and the tagline, "The Scientific Association Dedicated to Analytical Excellence," shown below. The typeface used is Largo. The AOAC tagline is owned by the Association and is registered with the U.S. Patent and Trademark office.

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AOAC INTERNATIONAL Policy on the Use of the Association Name, Initials, Identifying Insignia, Letterhead, and Business Cards Page 2

Policy Policy on the use of the Association's name and logo is established by the AOAC Board of Directors as follows:

“The Board approves and encourages reference to the Association by name, either as AOAC INTERNATIONAL or as AOAC; or reference to our registered trademark, AOAC®, in appropriate settings to describe our programs, products, etc., in scientific literature and other instances so long as the reference is fair, accurate, complete and truthful and does not indicate or imply unauthorized endorsement of any kind. The insignia (logo) of AOAC INTERNATIONAL is a registered trade and service mark and shall not be reproduced or used by any person or organization other than the Association, its elected and appointed officers, sections, or committees, without the prior written permission of the Association. Those authorized to use the AOAC INTERNATIONAL insignia shall use it only for the purposes for which permission has been specifically granted. The name and insignia of the Association shall not be used by any person or organization in any way which indicates, tends to indicate, or implies AOAC official endorsement of any product, service, program, company, organization, event or person, endorsement of which, has not been authorized by the Association, or which suggests that membership in the Association is available to any organization.”

The Executive Director, in accordance with the above stated policy, is authorized to process, approve, fix rules, and make available materials containing the Association name and insignia. It should be noted that neither the Association's name nor its insignia nor part of its insignia may be incorporated into any personal, company, organization, or any other stationery other than that of the Association; nor may any statement be included in the printed portion of such stationery which states or implies that an individual, company, or other organization is a Member of the Association.

Instructions 1. Reproduction or use of the Association name or insignia requires prior approval by the

Executive Director or his designate. 2. Association insignia should not be altered in any manner without approval of the

Executive Director or his designate, except to be enlarged or reduced in their entirety. 3. Artwork for reproducing the Association name or insignia, including those incorporating

approved alterations, will be provided on request to those authorized to use them (make such requests to the AOAC Marketing Department). Examples of the types of alterations that would be approved are inclusion of a section name in or the addition of an officer's name and address to the letterhead insignia.

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AOAC INTERNATIONAL Policy on the Use of the Association Name, Initials, Identifying Insignia, Letterhead, and Business Cards Page 3 4. When the Association name is used without other text as a heading, it should, when

possible, be set in the Largo typeface. 5. Although other colors may be used, AOAC blue, PMS 287, is the preferred color when

printing the AOAC insignia, especially in formal and official documents. It is, of course, often necessary and acceptable to reproduce the insignia in black.

6. Do not print one part of the logo or insignia in one color and other parts in another color. 7. The letterhead of AOAC INTERNATIONAL shall not be used by any person or

organization other than the Association, its elected and appointed officers, staff, sections, or committees; except by special permission.

Correspondence of AOAC official business should be conducted using AOAC letterhead. However, those authorized to use AOAC letterhead shall use it for official AOAC business only.

Copies of all correspondence using AOAC letterhead or conducting AOAC official business, whether on AOAC letterhead or not, must be sent to the appropriate office at AOAC headquarters.

8. AOAC INTERNATIONAL business cards shall not be used by any person or organization

other than the Association, its staff, and elected officials, except by special permission.

Those authorized to use AOAC business cards shall use them for official AOAC business only and shall not represent themselves as having authority to bind the Association beyond that authorized.

Sanctions

1. Upon learning of any violation of the above policy, the Executive Director or a designate

will notify the individual or organization that they are in violation of AOAC policy and will ask them to refrain from further misuse of the AOAC name or insignia.

2. If the misuse is by an Individual Member or Sustaining Member of the Association, and

the misuse continues after notification, the Board of Directors will take appropriate action. 3. If continued misuse is by a nonmember of the Association or if a member continues

misuse in spite of notification and Board action, ultimately, the Association will take legal action to protect its property, legal integrity, reputation, and image.

* * * * * * Adopted by the AOAC Board of Directors: September 24, 1989 Revised: June 13, 1991; February 26, 1992; March 21, 1995; October 1996

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Stakeholder Panel for Strategic Food Analytical Methods (SPSFAM) Hilton Washington DC/Rockville ● Hotel & Meeting Conference Center

Rockville, Maryland USA

DRAFT AGENDA

Thursday, June 30, 2011 ● 8:30 am – 4:30 pm Regency Room

I. WELCOME & INTRODUCTION

(Arora, Blanchard, and Bradford - 8:30 to 9:00 am)

II. AOAC NEW PATH FOR OFFICIAL FIRST ACTION METHODS (Bradford - 9:00 to 9:15 am)

III. STANDARD METHOD PERFORMANCE REQUIREMENTS (Coates - 9:15 to 9:30 am)

IV. PURPOSE & SCOPE OF THE PROJECT (Arora, Blanchard, and Bradford - 9:30 to 10:00 am)

BREAK AT 10:00 AM AND RETURN AT 10:30 AM

V. PRESENTATIONS AND VOTE ON WORKING GROUP PROPOSALS a. Antioxidants (Arora, Blanchard, Schaneberg - 10:30 am to 11:30 am)

LUNCH WILL BE PROVIDED - 11:30 NOON TO 12:30 PM

b. Flavonoid (Arora and Schaneberg - 12:30 to 1:30 pm) c. Contaminants (Lipp and Blanchard - 1:30 to 2:30 pm)

BREAK AT 2:30 PM AND RETURN AT 3:00 PM

d. Modernized Methods for Raw Ingredients (Austad – 3:00 to 4:00 pm)

VI. FUTURE TOPICS OF INTEREST (Arora and Blanchard - 4:00 to 4:15 pm)

VII. NEXT STEPS (Arora and Blanchard - 4:15 to 4:30 pm)

VIII. ADJOURNMENT

(Arora and Blanchard – 4:30 pm)

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Stakeholder Panel for Strategic Food Analytical Methods (SPSFAM)

SPSFAM Co-Chairs Arti Arora, Coca-Cola Company

LouAnne Blanchard, Kraft Foods

SPSFAM Advisory Panel

Arti Arora, Coca-Cola Company (Co-Chair) Prabhakar Kasturi, PepsiCo Lou Anne Blanchard, Kraft Foods (Co-Chair) Rama Rengarajan, Kellogg Company Jonathan W. DeVries, Sr., Medallion Laboratories Brian Schaneberg, Mars Botanical / General Mills Mathew Jones, Mars Botanical

SPSFAM Nutrients Working Group Chairs and Co-Chairs:

Antioxidants Arti Arora, Coca-Cola Company LouAnne Blanchard, Kraft Foods Brian Schaneberg, Mars Botanicals Flavonoid Arti Arora, Coca-Cola Company

Contaminants Markus Lipp, U.S. Pharmacopeia Convention LouAnne Blanchard, Kraft Foods Modernized Methods for Raw Ingredients John Austad, Covance Laboratory

Brian Schaneberg, Mars Botanical

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AOAC STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

SPSFAM Voting Members

ANA MARIA RONCO INTA, University of Chile ANGELO DE QUIERO MAURICIO Ministry of Agriculture of Brasil ARTI ARORA The Coca-Cola Company BRIAN T. SCHANEBERG Mars Botanical CATHERINE A. RIMMER National Institute of Standards and Technology GREGORY DIACHENKO FDA/CFSAN GUENTHER RAFFLER Central Laboratories Friedrichsdorf GmbH JAMES M. HARNLY USDA - ARS BHNRC JOHN AUSTAD Covance Laboratories JONATHAN W. DEVRIES, SR. Medallion Laboratories / General Mills

LIANG CHENG-ZHU Shan Dong Entry-Exit Inspection and Quarantine Bureau LOU ANNE BLANCHARD Kraft Foods LOUIS H. BLUHM USDA, LQAD, OPHS LAURA SHUMOW National Confectioner’s Association PAMELA GILLILAND Nestle USA, Inc. PRABHAKAR KASTURI PepsiCo RAMA RENGARAJAN Kellogg Company THOMAS W. CASTONGUAY University of Maryland ZOE GROSSER PerkinElmer, Inc.

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AOAC STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

Stakeholders in Attendance

ARORA, ARTI The Coca-Cola Company AUSTAD, JOHN Covance Laboratories BACLER, STAN Health Canada - Bureau of Chemical Safety JEROME, BAILEY Agilent Technologies BARRETT, W. BRADLEY AB SCIEX BECK, JONATHAN Thermo Scientific BHANDARI, SNEH Silliker, Inc. BHATT, PREMAL USP BLANCHARD, LOUANNE Kraft Foods BLUHM, LOUIS USDA, LQAD CAPAR, STEPHEN U.S. FDA - CFSAN CAPPS, ANDREW North Carolina Department of Agriculture CASTONGUAY, THOMAS University Of Maryland

CHARLES, DENYS Frontier Natural Products Coop. CHENG-ZHU, LIANG Shan Dong Entry-Exit Inspection and Quarantine Bureau CIFUENTES, ALEJANDRA LABSER COLLISON, MARK Archer Daniels Company COOK, JO MARIE Florida Department of Agriculture and Consumer Services Division of Food Safety CUNNINGHAM, DAVID Ocean Spray Cranberries, Inc. DAVID, PURI Nutrilite Division - Access Business Group, LLC DE OLIVEIRA, PAULA Thermo Fisher Scientific DEVRIES, JONATHAN Medallion Laboratories/ General Mills DIACHENKO, GREGORY FDA/CFSAN FELDSINE, PHILIP BioControl Systems, Inc.

FENG, PETER U.S. FDA - CFSAN GILLILAND, DONALD Abbott Nutrition GILLILAND, PAMELA Nestle USA, Inc. GRAVES, QIAN US FDA-CFSAN GROSSER, ZOE PerkinElmer, Inc. HAMMACK, THOMAS U.S. FDA - CFSAN HARNLY, JAMES USDA - ARS BHNRC HAYMAN, MELINDA Food Safety Net Services HENRY, TERESA Pharmavite HICKS, JOSHUA Bruker-BioSpin HO, JANE USDA, AMS, Science & Tech. HUANG, MIN Covance Laboratories HURST, JEFFREY The Hershey Co JEANVILLE, PATRICK Bruker Chemical and Applied Markets

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JONES, MATTHEW Mars Botanical KASTURI, PRABHAKAR PepsiCo KEITH, JASON CEM Corporation KNEETEMAN, ESTELA National Institute of Industrial Technology LABUDDE, ROBERT Least Cost Formulations, Ltd. LACORN, MARCUS R-Biopharm AG LAFON, WILLIAM Unilever LAURVICK, KRISTIE U. S. Pharmacopeia LI, FENG GUI LIPP, MARKUS U.S. Pharmacopeia Convention MANNING, GEORGE Bruker Daltonics MARAIS, JOHANNES Ocean Spray Cranberries, Inc. MCBRIDE, MARY Agilent Technologies, Inc. MILNE, PAUL SGS MOHAJER, SAM Canadian Food Inspection Agency

MONTES-NINO, ALFREDO Microbioticos Labs MOORE, JEFFREY US Pharmacopeia MOUNTFORD, MARDI International Formula Council (IFC) MU, JUN Jilin Entry-Exit Inspection and Quarantine Bureau NORMAN, MICHAEL Phenomenex NOVAK, CURT Agilent ORLANDI, PALMER FDA, Food Emergency Response Network, National Program Office PACQUETTE, LAWRENCE Abbott Nutrition PENG, LINDA DuPont Qualicon PHILLIPS, TOM Maryland Department of Agriculture RAFFLER, GUENTHER Central Laboratories Friedrichsdorf GmbH RAMA RENGARAJAN Kellogg Company REDDY, SHANKER USDA RIMMER, CATHERINE National Institute of Standards and Technology ROMANO, JOE Waters Corporation

RONCO, ANA INTA, University of Chile SCHANEBERG, BRIAN Mars Botanical SCHELLER, LORRAINE Southwest Research Institute SHEA, SHARON APHL SHUMOW, LAURA National Confectioners Association SULLIVAN, DARRYL Covance Laboratories SUNDARESAN, PERUVEMBA US FDA CFSAN SZPYLKA, JOHN Medallion Laboratories / General Mills TIJERINA, MARY USDA AMS MDP WOLF, WAYNE USDA, Food Composition Methods Development Laboratory WOOLLARD, DAVID New Zealand Laboratory Services Ltd. YANG, FANG Fujian Entry-Exit Inspection and Quarantine Bureau ZHANG, LINGSU USDA-AMS ZHIYONG, LI

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Russell S. Flowers, President Merriux NutriSciences Corporation 111 East Wacker Drive Suite 2300 Chicago, IL 606 01 USA Tel. +1(312) 938-5151 (O) Fax. +1(312) 729-1364 Email: russ.flowers@silliker.com Term: September 29, 2010 - September 21, 2011 Gayle A. Lancette, Past President FDA - Retired 1702 Yarborough Drive Peachtree City, GA 30269 -3618 USA Tel. +1(770) 487-6687 (O) Email: lancetteg@bellsouth.net Term: September 29, 2010 - September 21, 2011 Stan W. Bacler, President-Elect Health Canada - Bureau of Chemical Safety251 Sir Frederick Banting Driveway Room C223, Tunney's Pasture Ottawa, ON K 1A 0K9 Canada Tel. +(613) 941-1508 (O) Fax. +(613) 954-4674 Email: sbacler@hc-sc.gc.ca Term: March 29, 2011 - September 20, 2011 Jonathan W. DeVries, Sr., Treasurer Medallion Laboratories / General Mills 9000 Plymouth Avenue Minneapolis, MN 55427 -3870 USA Tel. +1(763) 764-2774 (O) Fax. +1(763) 764-2774 Email: jon.devries@genmills.com Term: September 29, 2010 - September 21, 2011 Darryl M. Sullivan, Secretary Covance Laboratories 3301 Kinsman Boulevard Madison, WI 53704 USA Tel. +1(608) 242-2711 (O) Fax. +1(608) 242-7903 Email: darryl.sullivan@covance.com Term: September 29, 2010 - September 21, 2011 Mark R. Coleman, Ph.D, Director Elanco / Eli Lilly & Co. 2500 Innovation Way Elanco Animal Health Greenfield, IN 46140 -0708 USA Tel. +1(317) 277-4613 (O) Fax. +1(317) 655-6557 Email: coleman_mark_r@lilly.com Term: September 29, 2010 - August 28, 2013 Douglas A. Hite, Director Tennessee Department of Agriculture 440 Hogan Road, Porter Building Nashville, TN 37220 USA Tel. +1(615) 837-5317 (O) Fax. +1(615) 837-5516 Email: douglas.hite@state.tn.us

Ronald L. Johnson, Director BioMerieux, Inc. 109 Candlelight Court Saint Peters, MO 63376 USA Tel. +1(314) 452-3241 (O) Fax. +1(314) 731-8678 Email: ron.johnson@na.biomerieux.com Term: September 16, 2009 - October 3, 2012 Xiumei Liu, Director Inst of Nutrition & Food Safety, Chinese Center For Disease Control & Prevention No. 7 Panjiayuannanli, ChaoYang District Beijing, 100021 Peoples Republic of China Tel. ++86-10-67770158 (O) Fax. ++86-10-67711813 Email: xmliu01@yahoo.com.cn Term: September 29, 2010 - August 28, 2013 Hilde Skaar Norli, Director NMKL C/o National Veterinary Institute PB 750 Centre Oslo, N -0106 Norway Tel. ++47 46 8888 07 (O) Fax. ++47 64 8708 07 Email: nmkl@vetinst.no Term: September 24, 2008 - September 20, 2011 David W.K. Acheson, Director at Large Leavitt Partners 1776 I Street, North West, 9th Floor Washington, DC 20006 USA Tel. +1(801) 910-5795 (O) Email: david@leavittpartners.com Term: January 1, 2011 - December 31, 2011 Clay Detlefsen, Esq., Director at Large International Dairy Foods Association 1250 H Street, North West Suite 900 Washington, DC 20005 USA Tel. +1(202) 220-3554 (O) Email: cdetlefsen@idfa.org Term: September 29, 2010 - September 21, 2011 James M. Harnly, Director at Large USDA - ARS BHNRC Food Composition and Methods Dev.Lab Methods Development Lab Beltsville, MD 2 0705 USA Tel. +1(301) 504-8569 (O) Fax. +1(301) 504-8314 Email: james.harnly@ars.usda.gov Term: September 29, 2010 - September 21, 2011

Board of Directors 2010-2011

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AOAC STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

AOAC STAFF LIAISONS

Delia Boyd Standards Development & Method Approval Processes E. James Bradford Executive Director Scott Coates Chief Scientific Officer Chris A. Bradley Customer Service Coordinator Jennifer Diatz Contract Programs Administrator Daniel Reiss Customer Service Coordinator Shane P. Flynn Director, Laboratory Proficiency Testing Arlene Fox Sr. Dir., Laboratory Proficiency Testing Dawn Frazier Sr. Dir., Membership & Professional Development Zerlinde Johnson Program Manager, AOAC Research Institute May Rose Jones Program Manager, Membership and Professional Development Liz. Korte Program Manager, Sections and Meetings

Nora Marshall AOAC Research Institute Krystyna McIver Sr. Dir., Stakeholder Communications Deborah McKenzie Sr. Dir., Standards Development & Method Approval Processes Alicia Meiklejohn Executive Office Tien Milor Managing Editor, Publications Anita Mishra Executive for Scientific Business Development Robert Rathbone Sr. Dir., Publications & Method Validation Gar Riegler Sr. Dir., Human Resources & Administration Joyce Schumacher Chief Financial Officer Virginia Trainor Contract Programs Administrator, Standards Development & Method Approval Processes Wendy L. Wheeler Program Manger, Customer Service and Proficiency Testing

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STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

Dr. Arti Arora, Co-Chair, SPSFAM Working Group Antioxidants and Flavonoid Arti Arora, Ph.D., is a Scientific and Regulatory Affairs Director at The Coca-Cola Company. In her current role, Arti provides scientific and regulatory guidance on issues related to food safety, chemistry and nutrition. She has over 10 years of food industry experience in various technical positions. Prior to joining The Coca-Cola

Company, Arti was a Technical Manager in the Food Chemistry labs at the Kellogg Company with responsibility for the chromatography and mass spectrometry groups. In her previous role as a post-doctoral researcher in the Department of Pharmacology & Toxicology at the University of Arizona, she studied the mechanisms of antioxidant actions for beta-carotene and genistein using LC/MS tools. Arti has held various leadership positions with the Institute of Food Technologists (IFT), American Chemical Society and American Oil Chemists' Society. She is currently on the Food Chemistry Executive Committee at IFT. She has served twice as a member of the USDA National Research Initiative grant review panel. She is currently a member of the External Advisory Committee for the Division of Nutritional Sciences at the University of Illinois. Arti received a Ph.D. in Food Chemistry from Michigan State University, a M.S. in Food Science from the University of Maine, and B.Sc. (Honors) in Nutrition from the University of Delhi.

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STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

Lou Anne Blanchard, Co-Chair, SPSFAM Working Group Antioxidants and Contaminants Lou Anne is currently a Section Manager at Kraft Foods in the Analytical Chemistry group in East Hanover, New Jersey. She leads the Quality research group and is responsible for all outsourced testing as well as

manufacturing testing. She holds B.S. degrees in Chemistry and Biochemistry from the University of Massachusetts at Amherst. She also has an M.S. degree in Food Science from Rutgers University. Lou Anne began her career in 1984 in the Food Service Products Division for General Foods in Cranbury, New Jersey working on coffee products. As General Foods was merged with Kraft Foods, she got to work on a broad list of product categories from cheese to cookies. She has a broad background in research including experiences in product development, analytical instrumentation and commercialization of products and ingredients. Prior to coming to Kraft Foods, she was a Specialist in the US Army.

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STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

Dr. Brian Schaneberg Working Group Flavonoid and Antioxidants Brian Schaneberg, Ph.D., is the Quality & Food Safety and Scientific & Regulatory Affairs Director for Mars Botanical, a business unit of Mars, Incorporated. Brian participates in the execution of product strategies while ensuring safety and regulatory guidelines are met and followed by the company. Brian has over 15 years of natural products experience in the area of dietary supplements and herbals. Most recently Brian

was the Director of Technical Services at ChromaDex, Inc. in Irvine, California. Prior to ChromaDex, Brian was an Associate Research Scientist at the National Center for Natural Products Research at the University of Mississippi under the guidance of Dr. Ikhlas Khan, in a position funded by the US FDA for the development of methods to ensure the quality and safety of botanicals and dietary supplements. Over the years, Brian has worked closely with industry, academia and government leaders. He has been a member of various review committees including NIH grants, analytical validation ERPs at AOAC and the Registry of Carcinogens. Brian also had the pleasure of holding an adjunct faculty position at the University of Colorado, Denver, advising a student that received his MS in Analytical Chemistry isolating phytochemicals and developing analytical testing procedures for Horse Chestnut. Brian has a Ph.D. in Organic Chemistry from Virginia Commonwealth University and a B.A. in Chemistry with a minor in Biology from Central College in Iowa. He has authored or co-authored more than 50 publications and presentations.

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STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

Dr. Markus Lipp Working Group Contaminants Dr. Markus Lipp is the Director for Food Standards at the U.S. Pharmacopeia (USP), an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. In this role, Dr. Lipp is responsible for the “Food Chemicals Codex”.

Prior to this position, he worked as the Director for Science and Research at the International Bottled Water Association and as the Global Lead for Detection Methods and Reference Materials relevant to genetically modified organisms at Monsanto Co’s headquarters in St. Louis, MO. Furthermore, his experiences include working for Unilever at their Dutch research facility and for the Joint Research Center of the European Commission at their facility in Italy, both position focused on ensuring food authenticity and safety, including the presence of genetically modified organisms in food.

Dr. Lipp holds a Ph.D. in analytical chemistry from the University of Karlsruhe, Germany.

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STAKEHOLDER PANEL FOR STRATEGIC FOOD ANALYTICAL METHODS

John Austad Working Group Modernized Methods for Raw Ingredients John Austad is a Manager in the Nutritional Chemistry and Food Safety Department at Covance Laboratories. In this role, he is responsible for leading a group of senior chemists in the development, validation and implementation of new and improved methods. He is also responsible for working with clients to develop and validate client specific methods.

Mr. Austad has been with Covance Laboratories for over 10 years where he has held various positions of increasing responsibility. During his tenure, he has held positions in several analytical testing groups that include: Method Development, Mineral Analysis, Fat Soluble Vitamins, Amino Acid Analysis, and Sugar Analysis. Mr. Austad is actively involved in the AOAC INTERNATIONAL. Mr. Austad has co-authored several poster presentations at the Annual AOAC meeting. Mr. Austad is a voting member of the SPIFAN Stakeholders Panel as well as having served and Chaired several Method Centric Review Committees. Mr. Austad holds a B.S. degree in Chemistry from the University of Wisconsin-Stevens Point. He resides in Sun Prairie, WI with his wife, Paula, and their son Landon.

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AOAC Proposal for Antioxidant measurement for the food industry

LouAnne Blanchard

Kraft Foods

Gaithersburg, Maryland, USA

Thursday June 30, 2011

121

Agenda

• Objectives

• Overview of Antioxidants

• Food Labeling Issues

• Regulatory Issues

• Analytical Issues

• Foods/Ingredients to Consider

222

Objectives

Establish a common knowledge about antioxidants

Discuss issues surrounding antioxidants

Discussion of Proposal

323

Overview of Antioxidants

• Categories• Additives to food

• Naturally present in whole foods

• Claimed health benefits• can interrupt or reverse natural progression

of oxidation as a result of aging

• Beneficial for certain chronic diseases 424

Chemistry of Antioxidants

• According to Fennema – “Antioxidants are substances that can delay the onset or slow the rate of oxidation of materials.”

• By quenching free radicals present or inhibiting the propagation of chain reaction

525

Chemistry of Antioxidants

• Total antioxdant power vs. specific claims• Whole foods have multiple AOX

• May operate synergistically

• How to quantify AOX power of whole food?

626

Regulatory Issues

• For additives• Labeling claims

• Implication of health benefits

• For whole foods• How can we talk about the positive benefits

of a whole food?727

Analytical Issues

• Ability to measure individual components

• Ability to quantify AOX power of whole food

• Link to bioeffectiveness

828

Overview of Analytical Methods

• What methods are in use• Specific for each compound

• Combination measuring total AOX

929

Proposal

• Define total antioxidant power

• Develop a fitness for purpose statements

• Create a Standard Method Performance Requirement (SMPRs) for the determination of total antioxidant power.

• Identify and prioritize major food/ingredients.

1030

Discussion

• Refine the proposal

• Set a timeline

• Volunteer Assignments

1131

Stakeholder Panel for Strategic Food Analytical Methods (SPSFAM)

Draft Proposal for Antioxidants Working Group

June 30, 2011 Proposal: 1. Define total antioxidant power 2. Develop a fitness for purpose statement

3. Create a Standard Method Performance Requirement (SMPRs) for the determination of total antioxidant power 4. Identify and prioritize major food/ingredients

32

AOAC Proposal on Flavonoid Measurement and Terminology

Brian Schaneberg

Mars, Botanical

Rockville, Maryland, USA

Thursday June 30, 2011

33

Agenda

• Objectives

• Overview of flavonoids

• Regulatory Issues

• Analytical Issues

• Foods/Ingredients to Consider

• Review and Discuss Proposal

34

Objectives

• Establish a common knowledge about flavonoids

• Discuss issues surrounding flavonoids

• Discussion of Proposal

35

Overview of Flavonoids• Definitions

• aromatic compounds that have two substituted benzene rings connected by a chain of three carbon atoms and an oxygen bridge

• secondary metabolites functioning as plant pigments and self defense

• Categories

• Claimed health benefits36

6 Main Flavonoid Classes in Human Diet

Flavonols Anthocyanidins Isoflavones

Flavanols Flavanones Flavones37

Claimed Health Benefits• Vasoprotective activity

• Cancer prevention

• Antioxidant

• Anti-inflammatory

• Anti-microbial

• Anti-allergic38

6 Main Flavonoid Classes in Human Diet

Isoflavones

Flavonols Flavones

Flavanols

Anthocyanidins FlavanonesLIN

KED

Procyanidins39

Flavonoid Regulatory Hurdles

• Accumulating evidence that foods high in flavonoids are associated with lower chronic disease risk.

• Gaps remain in the available science to meet the “significant scientific agreement” standard for health claims.

• Science has advanced largely discounting the traditional antioxidant effect to recognition as multi-faceted, complex bioactives.

• Inconsistent nomenclature and methodology in literature.

• No RDI for flavonoids. 40

Analytical Issues

• Fit-for-Purpose• Native Plant or Food matrix

• Biological matrix

• >5000 flavonoids isolated to date.

• Efficiency around analysis time and cost.

41

Overview of Analytical Methods

• Nonspecific methods• Ex. – ORAC and Folin-C

• Derivatization methods• Ex. – Hydrolysis

• Specific methods

42

Nonspecific Methods (UV)

• Quantifies color change

• Not applicable for ingredient identity

• Easily cheated

43

Derivatization Methods (HPLC/UV)

O

O

OH

OH

OH

OH

HO

O

O

OH

OH

HO

O

OH

OHO

OH O

OH

OH

Quercetin

Isorhamnetin

Kaempferol

1 2 3 4Total Flav

Gly 20.2% 22.1% 22.6% 25.3%

min0 10 20 30 40 50 60

mAU

-1

0

1

2

3

4

5

6

DAD1 A, Sig=360,16 Ref=600,100 (A3107\A3107_01.D)

7.7

42 8

.320

11.

583

11.

963

12.

809

13.

311

13.

962 14.

916

15.

400

16.

356

18.

978

19.

666

20.

722

21.

135

22.

267

23.

015

23.

485

23.

885

26.

518

27.

560

29.

495

33.

227

35.

126

37.

425

38.

446

39.

415

40.

249

41.

003

41.

210

42.

027

42.

993

43.

682

44.

418

45.

586

47.

252

min0 10 20 30 40 50 60

mAU

0

2

4

6

8

10

12

14

DAD1 A, Sig=360,16 Ref=600,100 (A3107\A3107_02.D)

7.8

75 8

.410

11.

862

12.

012

12.

857

13.

379

13.

972

14.

873

15.

303

16.

523

18.

835

19.

560

20.

599

20.

958

21.

246

22.

145

22.

499

23.

758

26.

367

27.

085

29.

215

32.

913

34.

768

37.

264

38.

259

39.

042

39.

966

40.

657

40.

819

41.

739

42.

617

43.

309

43.

976 4

5.40

5

46.

773

Ginkgo Extract

Adulterated Ginkgo Extract

44

Specific Method (HPLC/UV)

O

OH

OH

OH

OH

HO

O

OH

HO

OH

OH

OH

O

OH

HO

OH

OH

OH

OH

O

O

HO

OH

OH

OH

OH

O

OH

OH

OH

O

O

HO

OH

OH

OH

O

OH

OH

OH

Catechins (Flavanols)

45

Foods/Ingredients to Consider• Cocoa

• Tea

• Grape

• Cranberry

• Citrus

• Apple

• Soy

• Blueberry

46

Proposal

• Identify the major flavonoid sub categories

• Define flavanols

• Define the terms: “cocoa flavanols”, “procyanidins”, and “cocoa containing products.”

47

Cocoa Flavanols and Procyanidins

O

OH

HO

O H

O H

OH

O

O HO H

H O

O H

O H

O

O HO H

H O

O H

O H

O

O H

H O

O H

O H

O H

4

68

n(-)-Epicatechin(+)-Catechin

Procyanidins

The flavanols in cocoa are an unique mixture of simple flavanols (monomers) and more complex chains of 

flavanols known as procyanidins.

Monomers Oligomers

48

Cocoa Flavanols DP 1-10

HPLC/FLD method for the determination of cocoa flavanols (CF 1‐10) in cocoa containing products 

(chocolate, liquor, powder, bean and extract) against the relative response factor of (‐)‐epicatechin.49

Proposal

For total cocoa flavanols and procyanidins in cocoa containing products:

• Create a fitness for purpose statement.

• Identify candidate methods.

• Create a Standard Method Performance Requirement (SMPRs).

50

Draft Fit-for-PurposeGiven increasing interest in the health potential of phytonutrients and the continued advancement of understanding related specifically to the potent cardiovascular health effects of cocoa flavanolsand procyanidins, it would be very important to come to consensus on a standard reporting definition for flavan-3-ols and procyanidins in cocoa products and a standard assay method to meet this reporting definition in food products that contain a cocoa ingredient.

51

Discussion

• Refine the proposal

• Set a timeline

• Volunteer Assignments

52

Stakeholder Panel for Strategic Food Analytical Methods (SPSFAM)

Draft Proposal for Flavonol Working Group

June 30, 2011 Proposal: 1. Define - the major flavonoid sub categories

2. Create a fitness for purpose statement

3. Define the terms: “cocoa flavanols”, “procyanidins”, and “cocoa

containing products”

4. Create a Standard Method Performance Requirement (SMPRs) for the determination of total cocoa flavanols and procyanidins in cocoa containing products

5. Identify candidate methods for total cocoa flavanols and procyanidins in cocoa containing products

6. Prioritize work on the remaining flavonoid sub-categories

53

AOAC Proposal for Screening of Contaminants for the Food Industry

LouAnne Blanchard

Kraft Foods

Gaithersburg, Maryland, USA

Thursday June 30, 2011

54

Agenda• Objectives

• Types of Contaminants

• Product and Quality Issues

• Overview of Analytical Methods

• Database Concept

• Materials to Consider

• Proposal55

Objectives

Discuss the problem of contaminants

Discuss the database concept

Discuss and Refine the Proposal

56

Types of Contaminants• Unintentional

• Allergens

• Cross contamination

• Pesticide residues

• Economic Adulterants• Juices

• Olive oil

• Melamine57

Product and Quality Issues• Labelling

• Allergens present with no label

• Quality• Misrepresentation of product

• Damage to companies credibility

• Safety• Presence of hazardous material58

Overview of Analytical Screening Methods

Technology Advantages Drawbacks Cost ($)

Near Infrared SpectroscopyRapid analysis of macro contaminants, instrumentation already present in many plants, hand-held units available

Unable to detect low level contaminants 20K to 75K

Mid-Infrared Spectroscopy Rapid analysis of macro contaminants, able to ID unknowns

Unable to detect low level contaminants, new instrumentation for plants, sampling difficult

35K to 75K

Raman SpectroscopyRapid analysis of macro contaminants, hand-held units available, able to ID unknowns, relatively insensitive to water

Unable to detect low level contaminants, new instrumentation for plants, may have lower sensitivity than NIR

20K to 250K

FAIMS Rapid analysis of trace level volatile contaminants, potential for detecting spoilage

Only volatile contaminants detected, new instrumentation for plants 50K

NMRRapid analysis of macro and trace level contaminants, provides detailed structural information, can be very selective

Powerful magnets needed, new instrumentation for plants 40K to MM

Mass SpectrometryRapid analysis of trace level volatile contaminants, potential or detecting spoilage, can be very selective

Only volatile contaminants detected, new instrumentation for plants 40K to 500K

Hyperspectral ImagingRapid analysis across multiple spectroscopic regions, contaminant distribution information, can be very selective

Technology expensive, complex to use, new instrumentation for plants

200K and up

59

Concept of USP’s DatabaseSpectral Library is a Collection of Spectral ‘Fingerprints”…

Every pharmaceutical ingredient, formulated product, together with its packaging materials has unique characteristics or “fingerprints” that can be probed using various regions of the electromagnetic spectrum.

60

• The Good…• Drug products

• Essential drugs

• Drug of high values

• APIs

• Food Additive

• Botanicals

• Biologics

• The Bad (needles in the haystack)…• Counterfeit medicines

• Sub-standard medicines

• Adulterants

Spectral “fingerprints” USP is interested in collecting are:

61

What differentiates USP Spectral Library from other Libraries:

• USP will follow a set of SOPs on how to collect spectra• NIR SOP: Identification of Counterfeit Tablets and Authentication of

Medicines in the International Wholesaling Supply Chain by S. Assi, R,Watt and Anthony Moffat

• USP Spectral Library will be built based on “platform or instrument dependent” assumption – one instrument (platform) generates one spectral fingerprint

62

RAMAN Spectral Library

AhuraPerkin ElmerHORIBA-JobinVyon JascoRenishaw

NIRSpectral Library

BrukerPerkin ElmerThermo ShimazuFoss

MASS Spectral Library

Applied BiosystemsThermoWaters

High Resolution Image & Text Information Library

USP Spectral Library

Goal: Capture all analyzers representing 80% of the market share

Challenge : Orthogonal Analytical Method Development

- One Platform Generates One Finger Print

HPLC and NMR

63

64

Things to Consider

• Methods have limited detection limits

• Natural variability in raw materials

65

Proposal• Identify, review and agree on spectral

images of normal commonly used food ingredients that could be compared to new lots, batches to determine abnormalities.

• Identify and prioritize food ingredients.

• Agree on common procedure to measure to the degree of conformity and/or nonconformity.

66

Discussion

• Refine the proposal

• Set a timeline

• Volunteer Assignments

67

Stakeholder Panel for Strategic Food Analytical Methods (SPSFAM)

Draft Proposal for Contaminants Working Group

June 30, 2011 Proposal: 1. Identify, review and agree on spectral images of normal commonly used food ingredients (i.e. cocoa). These normal spectra could be compared to new lots, batches to determine abnormalities 2. Identify and prioritize food ingredients 3. Agree on common procedure to measure to the degree of conformity and/or nonconformity

68

AOAC Proposal for Raw Material Testing

John Austad

Covance Laboratories

Rockville, Maryland, USA

Thursday, June 30, 2011

69

Agenda

• Objectives

• Overview of Infant Formula Project

• Overview of Analytical Methods used by the Industry for Screening Raw Materials

• Consider which Raw Materials to work on

• Discuss Proposal

70

Objectives

Review the Work of SPIFAN

Consider how SPIFAN SMPRs and methods might apply to Raw Materials

Discussion Current Analytical Methods

Discussion of Proposal71

Overview of AOAC Infant Formula Project SPIFAN• Current Nutrients

• Vitamin A Folate

• Vitamin B12 Inositol

• Vitamin D

• Vitamin E

72

2nd Generation of Nutrients

• Nucleotides

• Ultra Trace Minerals (Cr, Mo. Se)

73

3rd Generation Nutrients

• Iodine

• Pantothenate

• L-Carnitine

74

Methods Identified for Infant Formula

75

Overview of Analytical Methods• What methods are in use today

• AOAC, USP, FCC, Japanese Pharmacopeia, European Pharmacopeia, etc

• Titration, Spectrophotometric, Simple Wet Chemistry methods, etc.

• While useful, many are outdated with current technology

• Manufacturer Internal Methods• Valuable but may be specific to a particular

company or product76

Analytical Issues for Raw Materials

• Operator Bias• Lack of Sensitivity• Lack of Specificity• Method extended for Raw Materials but may not

be appropriate• Lack of consistency in methodology used• No single accepted method for disputes

77

Raw Materials to Consider

• Pure Materials• Pure Vitamins and Minerals

• Premixes/Preblends• Mixtures of Vitamins and/or Minerals

• Commodity Materials• Grains, Fruits, Vegetables, others

• Fats and Oils78

Proposal

• Define raw materials and prioritize.

• Review Standard Method Performance Requirements (SMPRs) developed for infant formula and revise to be applicable to raw materials.

• Review methods identified for determination of nutrients in infant formula and determine applicability to raw materials.

79

Discussion

• Refine the proposal

• Set a timeline

• Motion to endorse proposal

• Volunteer Assignments

80

Stakeholder Panel for Strategic Food Analytical Methods (SPSFAM)

Draft Proposal for Modernizing Methods for Raw Materials Working Group

June 30, 2011

Proposal: 1. Define raw materials

2. Review Standard Method Performance Requirements (SMPRs) developed

for infant formula and revise to be applicable to raw materials 3. Review methods identified for determination of vitamins in infant formula

and determine applicability to raw materials

81

2ND Stakeholder Panel for Strategic Food Analytical Methods Meeting

(SPSFAM)

Held prior to 125th AOAC Annual Meeting & Exposition September 18-21, 2011

New Orleans, Louisiana USA ● The Sheraton Hotel

Visit www.aoac.org website for registration and hotel information.

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T H E A S S O C I A T I O N D E D I C A T E D T O A N A L Y T I C A L E X C E L L E N C E

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