November 14 2019 OMB Meeting Materials

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This ebooks contains information for the OMB teleconference on Thursday, November 14, 2019/

AOAC Official Methods Board November 14, 2019 Teleconference

AOAC INTERNATIONAL 2275 Research Blvd, Suite 300 Rockville, MD 20850

TELECONFERENCE INFORMATION For all locations, please see the Outlook Appointment CONFERENCE ROOM CODE: 741‐479‐421 #

OFFICIAL METHODS BOARD MEETING Thursday, November 14, 2019 2:00pm – 3:30pm ET Table of Contents

PRELIMINARY ITEMS 2018 ‐ 2019 OMB Roster

3 4 8 9

Policy Documents/Terms of Reference

AOAC Strategic Plan

Draft OMB Meeting Agenda*

11 14

OMB Meeting Minutes for October 10, 2019* Regulatory Rule Making and AOAC Impact

AOAC EXPERT REVIEW PANELS (ERP) Proposal for ERP for Furan Methods*

UPCOMING STANDARDS AND OFFICIAL METHODS SM ACTIVITIES AOAC Analytical Methods Week

122 123 124

AOAC Midyear Meeting Activities

Standards Development Approval Processes*

OFFICIAL METHODS BOARD COMMITTEES AND WORKING GROUPS SPIFAN ERP ‐ WG OMA Method Review Effort

142

EDITORIAL BOARD & PUBLICATIONS UPDATES Updates from the Editorial Board

152 153

Updates on Publications

AOAC ANNUAL MEETING ACTIVITIES Updates from OMB Liaisons (continued from October)

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AOAC OMB MEETING MATERIALS

AOAC INTERNATIONAL OFFICIAL METHODS BOARD

2019 – 2020 APPOINTED

Chair

Joe Boison Independent Consultant jboison@shaw.ca ; joeboison343@gmail.com Term 3: Sept. 12, 2019 – Aug. 31, 2022

Member

Salvatore Parisi Al Balqa Applied University drparisi@inwind.it Term 1: Sept. 12, 2019 – Aug. 31, 2022 Melissa Phillips US National Institute of Standards and Technology melissa.phillips@nist.gov Term 2: Sept. 12, 2019 – Aug. 31, 2022 Yvonne Salfinger Independent Consultant – AFDO & APHL AOAC Committee on Safety, Chair Term 3: Sept. 12, 2019 – Sept. 16, 2020 Sidney Sudberg, Alkemist Labs AOAC Committee on Statistics, Chair Sidney@alkemist.com Term 2: Sept. 12, 2019 – Aug. 31, 2022 ANSES – Laboratoire de Fougères Eric.VERDON@anses.fr Term 1: Sept. 28, 2017 – Sept. 16, 2020 Jon Wong US Food and Drug Administration Jon.Wong@fda.hhs.gov Term 1: Sept. 28, 2017 – Sept. 16, 2020 Erin Sutphin Crowley Q Laboratories, Inc. ecrowley@qlaboratories.com Term 3+: Sept. 12, 2019 – Aug. 31, 2022

Member Esther Campos Giménez Nestle Research Centre

Member

esther.campos‐gimenez@rdls.nestle.com Term 2: Sept. 12, 2019 – Aug. 31, 2022

Member Gabriel Giancaspro US Pharmacopeia gig@usp.org

Member

Term 1: August 30, 2018 – Sept. 1, 2021

Member

Member Brendon Gill

Fonterra Cooperative Group Ltd. Brendon.Gill@fonterra.com Term 1: August 30, 2018 – Sept. 1, 2021

Member Don Gilliland

Member Eric Verdon

Abbott Nutrition don.gilliland@abbott.com Term 2: August, 30, 2018 ‐ Sept. 1, 2021

Member

Member Katerina Mastovska

Eurofins Integrity & Innovation Katerina.Mastovska@eurofinsUS.com Term 2: August 30, 2018 ‐ Sept. 1, 2021

Member Wendy McMahon

Past Chair (Ex‐ officio Member)

Mérieux NutriSciences wendy.mcmahon@mxns.com Term 2: Sept. 12, 2019 – Aug. 31, 2022

AOAC Staff Liaisons

Deborah McKenzie Sr. Director, AOAC Standards Development Sr. Director, AOAC Research Institute dmckenzie@aoac.org

Delia Boyd Program Manager, AOAC Standards Development dboyd@aoac.org

AOAC INTENATIONAL Terms begin following the AOAC Business Meeting. Terms expire at the AOAC Business Meeting. Version 1

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ACCESS TO AOAC BYLAWS, POLICIES & PROCEDURES, AND STRATEGIC PLAN AOAC INTERNATIONAL Bylaws (2019) The excerpt from the Bylaws below is Article VIII which pertains to the Official Methods of Analysis and the Official Methods Board. ARTICLE VIII Official Methods of Analysis The Board of Directors (BoD) is empowered to develop written policies and procedures for the study, adoption, and change in status of the Official Methods of Analysis of AOAC INTERNATIONAL. Implementation of the policies and procedures shall be delegated to an Official Methods Board (OMB). Section 1. Composition of the Official Methods Board The Official Methods Board shall consist of a chair and a vice chair, and members who are recommended by the chair. The chair, vice chair and members are appointed by the President of AOAC INTERNATIONAL. The OMB shall be composed of members representing a balance of government, industry, and academia as appropriate to the scope of the group and shall not be dominated by any single interest. Section 2. Purpose of the Official Methods Board The OMB shall serve the Association in a scientific and advisory capacity on methods and the process of their adoption. The OMB shall be responsible for implementation of procedures adopted by the BoD, according to the principles in section 3 below. Section 3. Principles of the Official Methods Program A. Adequate records of technical data, discussions, and decisions on the study, adoption, and change of status of Official Methods of Analysis shall be maintained for a reasonable time. B. Timely notice of proposed method studies, adoption, or change in status shall be published in an Association publication that is circulated to the members. C. Opportunity shall be provided for materially interested parties to submit input during method study and adoption procedures and to submit comments on the adoption, use of, or change in status of specific methods. D. Methods submitted to the OMB for inclusion in the OMA shall be thoroughly studied, scientifically reviewed, and available in published form prior to adoption as Final Action by the OMB. E. The OMB shall adopt methods as Final Action. AOAC INTERNATIONAL Policy on Antitrust Below is an excerpt from the Policy that are the guidelines to be followed. 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.

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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. AOAC INTERNATIONAL Policy on Use of Association Name, Initials, Identifying Insignia, Letterhead and Business Cards Below is an excerpt from the Policy statement. 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 1. Do avoid the appearance as well as the fact of a conflict of interest. 2. Do make written disclosure of any material interest which may constitute a conflict of interest or the appearance of a conflict of interest. 3. Do not accept payment or gifts for services rendered as a volunteer of the Association without disclosing such payment or gifts. 4. 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. 5. 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. 6. 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. AOAC INTERNATIONAL Policy on Volunteer Conflict of Interest Below is an excerpt from the Policy of Do’s and Don’t’s

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AOAC INTERNATIONAL

TERMS OF REFERENCE

I . NAME:

OFFICIAL METHODS BOARD (OMB)

II. MISSION:

To serve the Association in a scientific and advisory capacity on standards and methods with ethical, timely, open and independent scientific oversight for the implementation of standards development and conformity assessment policies and procedures of AOAC INTERNATIONAL.

III. RESPONSIBILITIES:

To provide ethical, timely, open and independent scientific oversight for the policies and procedures of AOAC INTERNATIONAL.

To approve “Final Action” status for First Action Methods (new and revised) following a proactive review;

To repeal methods, if necessary, in accordance with established policies and procedures;

To participate in addressing appeals and requests for action or guidance, and in resolving disputes;

To endorse and monitor all voluntary consensus panels for appropriate representation and balance of stakeholders’ perspectives; To endorse and monitor all volunteer subject matter experts for volunteer conformity assessment activities;

To adopt and monitor scientific and technical guidance and references;

To acknowledge outstanding scientific and technical volunteer activity and achievement within AOAC;

To actively participate in AOAC standards development activities and maintain and communicate explicit knowledge of AOAC standards development and conformity assessment;

IV. COMPOSITION AND ORGANIZATION:

OMB consensus on January 29, 2013 AOAC INTERNATIONAL Board of Directors: Approval on April 26, 2013 OMB consensus on August 8, 2013 AOAC INTERNATIONAL Board of Directors Approval on August 25, 2013

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The Official Methods Board shall consist of up to 13 voting members including a Chair, a Vice‐chair, the Chair of the Committee on Safety and the Chair of the Committee on Statistics. The Committee on Safety and the Committee on Statistics may contain co‐chairs. The co‐chairs for these committees represent one vote on the OMB. Members of the OMB may serve in multiple volunteer roles for the benefit of the Association. The Chair of the Official Methods Board shall have previously served as a member of the Official Methods Board. The Chair, Vice‐chair, and members of the Official Methods Board including the chairs of standing committees shall be appointed for a term of three years. A member of the OMB may be reappointed upon the recommendation of the Chair of the Official Methods Board with a maximum term of service of six (6) years. Exceptions may be made at the discretion of the President. The Chair of the Official Methods Board is eligible to serve an additional post chair term of up to three (3) years as an ex‐officio member. Members of the Official Methods Board must be members of AOAC.

All members of the Official Methods Board are recommended by the Chair and appointed by the President. All Official Methods Board members serve at the pleasure of the President.

The Official Methods Board represents the membership of AOAC INTERNATIONAL. It shall be composed of members representing a balance of scientific expertise, government, industry, and academia as appropriate to the scope of the Board. Every effort should be made to include international representation on the Board. Additional working groups, task forces, and other appropriate subgroups shall be appointed as needs arise by the Chair of the Official Methods Board.

V. STAFF LIAISON: The Executive Director shall assign a member of the staff to serve as staff liaison.

VI. REVIEW SCHEDULE:

Every three years.

VII. DATE ESTABLISHED:

Renamed in 1981

VIII. DATES REVIEWED

01/ 20 08, 7/2016

IX. DATES REVISED: 9/89; 5/90; 1/91; 8/06; 02/07; 07/07; 2/08; 4/13; 8/13

OMB consensus on January 29, 2013 AOAC INTERNATIONAL Board of Directors: Approval on April 26, 2013 OMB consensus on August 8, 2013 AOAC INTERNATIONAL Board of Directors Approval on August 25, 2013

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AOAC INTERNATIONAL Strategic Plan AOAC OMB MEETING MATERIALS

Vision

Global confidence in consensus based analytical solutions for food safety, food integrity, and public health.

Mission

As a leader of analytical excellence, AOAC INTERNATIONAL advances food safety, food integrity, and public health, by bringing together members, organizations, and experts dedicated to developing and validating standards, methods and technologies, of global relevance.

Goals

Address emerging issues and influence standards development as a global leader in analytical excellence. Attract and develop deeply engaged members, volunteers, staff, and customers to grow and strengthen the association and its programs. Build strategic partnerships to advance food safety, food integrity, and public health.

Analytical Excellence

People

Relationships

Develop and improve existing core programs, products, and services.

Core Programs

Identify, strengthen, and grow revenue streams to ensure the association’s long-term sustainability.

Sustainability

Establish a highly effective governance and leadership culture providing value to all members and stakeholders.

Governance

December 13, 2017 AOAC INTERNATIONAL

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OFFICIAL METHODS BOARD TELECONFERENCE Thursday, November 14, 2019 – 2:00PM – 3:30PM ET

DRAFT MEETING AGENDA

Joe Boison (Independent Consultant), Chair and Meeting Moderator

I. PRELIMINARY ITEMS a. Welcome and Introductions (Boison)

Boison will invite staff to conduct a roll call of OMB members to ensure a quorum of members are present. Any proxies will be identified. The status of the meeting will be determined based on a quorum of OMB members present at the roll call.

b. Call to Order/Announcements/Review of Policy Documents/Terms of Reference (Boison) Boison will call the meeting to order and invite OMB members to review the OMB roster, the AOAC policies and bylaws, the OMB Terms of Reference, and the AOAC Strategic Plan. c. Review of OMB November 14, 2019 Teleconference Draft Agenda* (Boison) OMB members are expected to review the draft agenda and suggest any additions or deletions prior to reaching consensus on a final version of the agenda. d. Review of October 10, 2019 OMB Meeting Draft Minutes* (Boison) OMB members are expected to review the draft meeting minutes and suggest any edits or modifications prior and if possible, reaching consensus on a final version of the meeting minutes. II. AOAC EXPERT REVIEW PANELS (ERPs) a. Proposal for New ERP for Furan Methods (McKenzie)* McKenzie will review recommendations for forming a new ERP for Furan Methods that follows the approval of the SMPR for furan and alkyl furans . III. UPCOMING STANDARDS AND OFFICIAL METHODS SM ACTIVITIES (McKenzie) a. AOAC Analytical Methods Week (McKenzie) McKenzie will update the OMB on activities for Analytical Methods Week and make request for OMB liaisons if there are no OMB members participating. b. AOAC Midyear Meeting (McKenzie) McKenzie will update OMB members on the schedule of the Midyear meeting to date. Boison and McKenzie will ask OMB members about potential meeting days for the AOAC Midyear meeting. e. Regulatory Impact – USDA and US FDA Latest Decisions (McKenzie) McKenzie will share with the OMB the latest in regulatory rule making that includes mention of AOAC.

c. Standards Development Approval Processes (McKenzie)* McKenzie will update the OMB on the proposal for revising the standards development approval process.

IV. OFFICIAL METHODS BOARD COMMITTEES AND WORKING GROUPS a. SPIFAN ERP ‐ WG OMA Method Review Effort McKenzie will share with OMB the formation of a working group to draft requirements for consideration when reviewing Official Methods action status in updating of OMA. b. Committee on Statistics (Sudberg/McKenzie)

* Items that require or may require a vote during meeting or via e‐ballot

Preliminary Agenda for OMB Meeting – November 10, 2019 version 2

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Sudberg will provide an update on recent activities within the Committee that may be ready for OMB review. McKenzie will share discussion of process for approvals from Committee.

V. EDITORIAL BOARD & PUBLICATIONS UPDATES a. Editorial Board (Gill/Phillips/Boison/McKenzie)

Phillips, Gill, and Boison will provide verbal updates on Editorial Board activities. McKenzie will also discuss timing for Annual Meeting sessions of OMB and Editorial Board, and OMA Editor succession and assistance with questions on OMA methods. b. Publications (McKenzie/Diatz) McKenzie will share processes changes that will impact Standards, OMA program, and Publications.

VI. AOAC ANNUAL MEETING ACTIVITIES a. Updates from OMB Liaisons (Boison/McKenzie)

During the October OMB teleconference, there were a few meetings in which OMB liaisons did not provide updates. Boison will invite those OMB liaisons to update OMB on Annual Meeting activities noting accomplishments, needs for further support, assistance, and education, and any implementation of or need for consideration of technical or process improvements or enhancements. Date Events (not all inclusive) Friday, September 6, 2019 Food Authenticity Saturday, September 7, 2019 CASP, SPIFAN, ERP for SPIFAN Nutrients Sunday, September 8, 2019 Analytical Solutions Forum, Furans WG, BOD, TDLM/TDRM Monday, September 9, 2019 TDRM, Keynote & Awards, Quantitative Microbiology WG, ERP for Microbiology Tuesday, September 10, 2019 AOAC ‐ ISO ‐ IDF, Standards & Methods, Food Allergens WG, Statistics, and ERP for Low Lactose Wednesday, September 11, 2019 FSSAI & India Section, ERP for Veterinary Drug Residues, Task Group on TDRM, Business Mtg Thursday, September 12, 2019 OMB Discussion and Validation Training Course

VII. ADJOURNMENT

* Items that require or may require a vote during meeting or via e‐ballot

Preliminary Agenda for OMB Meeting – November 10, 2019 version 2

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OFFICIAL METHODS BOARD TELECONFERENCE Thursday, October 10, 2019 – 2:00PM – 3:30PM ET D RAFT M EETING M INUTES

OMB MEMBERS (present during all or part of the meeting) Joe Boison Independent Consultant

Chair

Esther Campos Gimenez

Nestle Research Centre Fonterra Cooperative

Member Member Member Member Member Member Member Member Member Member Member

Brendon Gill Don Gilliland

Abbott Nutrition

Katerina Mastovska Wendy McMahon Salvatore Parisi Melissa Phillips Yvonne Salfinger Sidney Sudberg

Eurofins

Mérieux NutriSciences Al Balqa Applied University

US NIST

Independent Consultant

Alkemist

Eric Verdon Jon Wong Erin Crowley

ANSES – Laboratoire de Fougeres

US FDA

Q Laboratories

Past Chair ‐ Ex ‐ Officio

OMB MEMBERS (absent with regrets) Gabriel Giancaspro

US Pharmacopeia

Member

AOAC STAFF (present during all or part of the meeting) Delia Boyd Deborah McKenzie

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1 2 3 4 5 6 7 8

PRELIMINARY ITEMS

Call to Order/Introductions/Announcements

Boison called the meeting to order at 2:04 pm ET. Boison took a moment to welcome OMB members to their first teleconference meeting of the 2019 ‐ 2020 term and invited

members to review their information on the roster.

Review of AOAC Policy Documents

Boison called OMB’s attention to the AOAC policy documents, reminded all attendees to review the documents, and that the meeting will be held in accordance to these policies.

9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51

Review and Approval of Draft Meeting Agenda MOTION: For OMB to approve the agenda as presented. Gilliland moved, and Verdon seconded. Consensus: Unanimous. Review June 13 and 27, 2019 of Draft OMB Meeting Minutes MOTION: For OMB to approve the OMB meeting minutes as revised. Wong moved, and Phillips seconded. Consensus: Unanimous.

ACTION ITEM: Item IV.c., line 2 – replace “some many members” with “so many

members”

OMB Reports to the AOAC Board of Directors and Annual Business Meeting Crowley provided an update on the OMB reports to the AOAC Board of Directors and Annual Business Meeting. Boison congratulated Crowley on being President ‐ Elect and

thanked her on behalf of the OMB for her leadership.

OMB Monthly Teleconferences/Meeting Times and SharePoint

Boison asked OMB members to confirm if the second Thursday of each month at 2:00pm ET is still a good time for everyone to meet. There was no opposition to the time. Boyd then discuss use of OMB SharePoint site for OMB activities and materials. Some members expressed a desire to have more information on using SharePoint. ACTION ITEM : Boyd agreed to provide a tutorial on using the OMB SharePoint site.

II.

AOAC ANNUAL MEETING ACTIVITIES

Updates from Official Methods Board Liaisons

OMB members provided updates on meetings attended during the Annual Meeting. OMB liaisons were not able to complete an update for all the meetings attended.

ACTION ITEMS:

1. Add meetings that were held on Tuesday, Statistics, ERP for Low Lactose Methods;

meetings held on Wednesday and Thursday to November agenda

2. Inform Palmer Orlandi about a request for discussion with McMahon and Crowley resulting from presentation during ERP for Microbiology for Food and Environmental

Surfaces.

III.

OMB ACTIVITIES AND STRATEGY FOR 2019‐2020 TERM OMB Activities and Strategy for 2019‐2020 Term a.

McKenzie shared with OMB a presentation that outlines much of the work before the

OMB this year for their review.

Review of AOAC Methods

Gilliland and Gill mentioned the need for OMB to lay the foundation for requirements for reviewing Official Methods by which decisions are made to maintain as Official Methods or repeal. This was

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1 2 3 4 5 6 7 8 9

mentioned as a matter of urgency in reference to the OMB the new project under SPIFAN with the review of First Action OMAs for which method reproducibility will not be assessed. ACTION ITEM: McKenzie to discuss further with Boison during next OMB Core call.

Recruitment of New Members for Committee on Statistics

Sudberg mentioned requesting help from OMB on recruiting new members as a committee

priority.

ACTION ITEM: McKenzie to discuss further with Boison during next OMB Core call.

10 11 12 13 14 15 16 17 18 19 20

IV.

EDITORIAL BOARD & PUBLICATIONS UPDATES Updates from the Editorial Board Tabled until November teleconference. a.

Updates on Publications

Tabled until November teleconference.

ADJOURNMENT

All other agenda items were tabled and will be added to the November teleconference agenda.

MOTION: Motion to adjourn

Sudberg moved and Verdon seconded. Consensus: Unanimous – Meeting adjourned at 3:31pm ET.

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MEMORANDUM

Date:

November 14, 2019

To:

AOAC INTERNATIONAL Official Methods Board

From:

Deborah McKenzie, Staff Liaison – AOAC Official Methods Board

Subject:

Latest Government Rule Making Updates

For your information, below are US regulatory proposed rules or rules that have been published in the US Federal Register in since the last OMB teleconference. These documents reference AOAC INTERNATIONAL in them either the ALAAC, SMPRs or Official Methods of Analysis .

Laboratory Accreditation for Analyses of Foods (PROPOSED RULE) By the US Food and Drug Administration on 11/04/2019. https://www.federalregister.gov/documents/2019/11/04/2019 ‐ 23870/laboratory ‐ accreditation ‐ for ‐ analyses ‐ of ‐ foods Establishment of a Domestic Hemp Production Program (RULE) By the USDA Agricultural Marketing Service on 10/31/2019. https://www.federalregister.gov/documents/2019/10/31/2019 ‐ 23749/establishment ‐ of ‐ a ‐ domestic ‐ hemp ‐ production ‐ program Clean Water Act Methods Update Rule for the Analysis of Effluent (PROPOSED RULE) By the US Environmental Protection Agency on 10/22/2019. https://www.federalregister.gov/documents/2019/09/17/2019 ‐ 19862/addition ‐ of ‐ a ‐ new ‐ method ‐ for ‐ the ‐ analysis ‐ of ‐ sulfites ‐ in ‐ foods Addition of a New Method for the Analysis of Sulfites in Foods (PROPOSED RULE) by the US Food and Drug Administration on 09/17/2019. https://www.federalregister.gov/documents/2019/09/17/2019 ‐ 19862/addition ‐ of ‐ a ‐ new ‐ method ‐ for ‐ the ‐ analysis ‐ of ‐ sulfites ‐ in ‐ foods

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MEMORANDUM

Date:

October 23, 2019

To:

AOAC INTERNATIONAL Official Methods Board

From:

Deborah McKenzie, Staff Liaison – AOAC Official Methods Board

Subject:

New Expert Review Panel (ERP) for Furans in Select Foods Methods

BACKGROUND AOAC has had a Furans Working Group that developed a standard method performance requirements (SMPR®) for determination of Furan and Alkyl Furans in Coffee, Baby Foods including Infant Formula, Cereals, and Fruit Juices. Please find below a proposal for an expert review panel (ERP) to review methods received as a result of a call for methods for that specific SMPR. A call for experts was issued to solicit applicants to form a furans ERP. Fourteen (14) applications were received with varying levels of experience and expertise. Table I is a proposed roster for the ERP based on review of summaries of expertise, CVs, and any known AOAC related activity. RECOMMENDATION OMB to review the proposal for a new ERP for Furans in Select Foods Methods in Table I using the applicant information including: Perspectives of Proposed ERP, Table II – List of Applicants, Perspectives of Applicants, Statements of Expertise with Staff Recommendations, and CVs, and render a decision on this ERP and verify the status for all applicants.

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Methods Expected for Review 1 1. Determination of Furan and Alkylfurans in Coffee, Baby Foods, Infant Formula, Cereals, and Fruit Juices. Authors: NANCY FRANK, MATHIEU DUBOIS Supporting Organization: Nestlé 2. Standard Operation Procedure for the Testing of Furans and Methylfurans Compounds in Key Foods (HS/GC/MS) Authors: Lei Zhang, Pinggu Wu, Zhaoping Liu, Zheng Chen, Pingping Zhou Supporting Organization: China National Center for Food Safety Risk Assessment

Note : Call for Methods remains open until October 31, 2019. 1

II.

Proposed ERP for Furan in Select Foods Methods: 2019 Applicants

First

Last

Organization

Region

Position Member Member Member Member Member Member Member Member Member Member Member Member

Sneh

Bhandari

Mérieux NutriSciences

USA USA USA

Yumin

Chen

PepsiCo R & D Abbott Nutrition Nestlé Research

Jonathan Mathieu

Draher Dubois

Switzerland Member

Nour Eddine Es ‐ Safi

Mohammad V University In Rabat Eurofins Food Integrity and Innovation Eurofins Central Analytical Laboratories

Morocco

Katerina

Mastovska

USA USA Italy USA USA USA USA

Arun

Paga Parisi

Salvatore

Al ‐ Balqa Applied University State Chemist Section The Coca ‐ Cola Company

Tom Kasi

Phillips

Somayajula

Cheryl

Stephenson Eurofins Central Analytical Laboratories

John

Szpylka

Mérieux NutriSciences

Pinggu

Zhejiang Center for Disease Control And Prevention China National Center for Food Safety Risk Assessment

China

Pingping

Zhou

China

Member

1 https://www.aoac.org/news/call ‐ for ‐ methods ‐ methods ‐ for ‐ quantitation ‐ of ‐ furan ‐ and ‐ alkyl ‐ furans ‐ in ‐ selected ‐ matrices/

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III.

Perspectives of Proposed ERP Members

Furans ERP ‐ Broad Perspectives

14%

65%

Industry Academia Government

NGO

Furans ERP ‐ Specific Perspectives

7% 7% 7%

36%

14%

29%

CRO

Food/Beverage State Government

Research

International Government / Public Health Food Safety

Regional Perspectives

14%

7% 7%

65%

Regional

China Italy Morocco Switerland USA

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IV. Applicant Statements of Expertise and Senior Staff Recommendations

Sneh Industry Very familiar with the Furan and Dioxin issues and methodologies, the discussion on them was a substantial part of my review I published in Food Safety Handbook on Hazards from environmental, industrial, and agricultural contaminants. Quite familiar with methodologies and aspects of regulations Staff Comments: STAFF RECOMMENDATION: Highly recommend Industry Solid experience in LC ‐ MS analysis and professional interest in furan analysis in food system Staff Comments: STAFF RECOMMENDATION: Highly recommend Industry Member of the AOAC Furans working group. Internal Abbott Nutrition subject matter expert on furans. Conducted a collaborative study with AN medical safety and EU government regulators to better understand the effects of in home powder reconstitution on Furan levels in infant formula. Staff Comments: STAFF RECOMMENDATION: Highly recommend Industry I have been working on Furan and alkylfuran since early 2018 to develop and validate analytical methods for measurements of furan, 2 ‐ & 3 ‐ methylfuran, 2 ‐ ethylfuran, 2,5 ‐ dimethylfuran and 2 ‐ pentylfuran in food. On this topic, I have been working on various techniques, including static headspace coupled to GC ‐ MS, SPME ‐ GC ‐ MS but also dynamic headspace (Turbomatrix) coupled to GC ‐ MS. I was leading an activity during this period to mainly extend to the above mentionned analytes using an existing method targetting only furan, but also comparing the different techniques for a accurate quantification of these compounds. Besides, I am familiar with AOAC processes, as I was a member of the MCPD ERP in 2018, and also author of a AOAC first action method (2018.03) for MCPDE and GE analysis by GC ‐ MS/MS. I am currently the study director of the MLT for method 2018.03. Staff Comments: STAFF RECOMMENDATION: Highly recommend Bhandari Merieux NutriSciences Yumin Chen PepsiCo R & D Jonathan Draher Abbott Nutrition Mathieu Dubois Nestlé Research Centre

Nour Eddine

Es ‐ Safi

Mohammad V University in Rabat

Academia

Chemist with expertise in the field of analytical chemistry Staff Comments: He is on numerous ERPs and adds an academic perspective. STAFF RECOMMENDATION: Not sure?

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AOAC OMB MEETING MATERIALS

Katerina Industry Extensive experience in the analysis of chemical contaminants, including volatile compounds using GC ‐ MS. Furans working group chair Staff Comments: Was recommended by the Advisory Panel as one of the experts to serve as WG chair for the Furans WG STAFF RECOMMENDATION: Highly recommend Industry Working as Method Development Scientist in designing and performing analytical development studies. Over 10 years of analytical experience with headspace GC ‐ MS and GC ‐ MS/MS analysis. Currently in the working group for Furans. In the process of developing method for Analysis of Furan metabolites by Headspace GC ‐ MS Staff Comments: STAFF RECOMMENDATION: Highly recommend Academia I am currently a member of the AOAC Furans Working Group. Also, my initial works and thesis on natural substances were focused on terpenoids and several heterocyclic molecules, including compounds containing furan rings (extractions and NMR characterization). Staff Comments: STAFF RECOMMENDATION: Highly recommend State Government I have about 4 years of experience dealing with furans in coffee and in fruit juice using a variety of techniques. Staff Comments: STAFF RECOMMENDATION: Highly recommend ‐ Served as ERP member for AOAC BPA method for beverages. ‐ Expertise in method development for volatiles/non ‐ volatile analysis in variety of matrices using GCMS and LCMS etc. ‐ Over 30 years of experience in analytical chemistry in the area of mass spectrometry; qualitative and quantitative analysis. Staff Comments: STAFF RECOMMENDATION: Highly recommend Mastovska Eurofins Food Integrity and Innovation Arun Paga Eurofins Central Analytical Laboratories Salvatore Parisi Al ‐ Balqa Applied University Tom Phillips State Chemist Section Kasi Somayajula The Coca ‐ Cola Company Industry

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AOAC OMB MEETING MATERIALS

Cheryl Eurofins Central Analytical Laboratories Industry Routinely provide this testing to food industry utilizing headspace ‐ GC ‐ MS. Have validated inhouse procedure so fully understand complications and pitfalls. Staff Comments: STAFF RECOMMENDATION: Highly recommend Industry I consult on analysis of contaminants such as dioxin/furans is typically performed using high resolution MS, performed at our Crete laboratory. I have lengthy experience on properly validating such methods of analysis and a deep understanding of AOAC requirements for this level of testing. Staff Comments: STAFF RECOMMENDATION: Highly recommend Government Engaged in health physical and chemical analysis, long ‐ term responsibility for food safety risk monitoring in Zhejiang Province. Two national food safety standards, including the determination of ethyl carbamate in food and polycyclic aromatic hydrocarbons in food, have been drafted, 12 local standards have been drafted, acquired four national patents for inventions and participated in the compilation of 5 works. published more than 100 articles, including more than 20 SCI papers. Staff Comments: STAFF RECOMMENDATION: Highly recommend Public Health Zhou Pingping has 8 years experience in chemical pollutant monitoring laboratory, and is familiar with gas chromatography and gas chromatography mass spectrometry. She has also some experience in liquid chromatography mass spectrometry instruments. She has been engaged in the detection of trace persist organochlorine pesticides, melamine, acrylamide, 3 ‐ chloro ‐ 1,2 ‐ propanediol, ethal carbamate and furans in food and established a series of quantity analysis and confirmation standards and methods. She has also organized several domestic laboratories to take part in the international comparison of acrylamide research as well as to pass with very good results the FAPAS tests on organochlorine pesticides and acrylamide etc. Moreover, she has drafted China’s national detection standards and limit standards of some key pollutants. Staff Comments: STAFF RECOMMENDATION: Highly Recommend Stephenson John Szpylka Mérieux NutriSciences Pinggu Wu Zhejiang Center for Disease Control and Prevention Pingping Zhou China National Center for Food Safety Risk Assessment

12/11/2019

AOAC OMB MEETING MATERIALS

Sneh Bhandari

Chemistry Research & Development Director, Merieux NutriSciences (Silliker Laboratories), 3600 Eagle Nest Drive, Crete, IL 60417.

Current Position

Since May, 1997

Silliker Laboratories

Crete, IL

Experience

Chemistry Research Director  Direct & Manage the chemistry research and serves as a resource to the Silliker clients to resolve their analytical issues.  Working with corporate to plan budget, growth and development of the department.  Write proposals to justify research studies. Create research reports to summarize the findings and discuss those in relation to the objective and existing knowledge.  Design research studies, experiments and protocols. Work with in guidelines of ISO 17025.  Work with National & International Agencies to lead efforts in improving method of food, dietary supplement analysis  Fellow of AOAC. Expert review panel and strategic committee member for AOAC SPIFAN program.  Chair AOCS Analytical Division.  Member Chromatography Division, AOCS  Help clients about regulatory guide lines (FDA, USDA) including nutritional labeling.  Wrote a chapter on food hazards resulting from environmental, industrial and agricultural contaminants.  Made various presentations at professional and scientific meetings including AOAC, IFT, AOCS etc.  Managed special projects like stability testing, method validation including studies to fill in the gaps cited in FDA form 483 and other audits.  Helped clients to study oil authenticity and also oil adulteration.  Served on various AOAC Expert Review Panels and Stakeholder Panels.  AOAC Technical Committee member for Additives (2004-2007).  Was involved in EPR for vitamin E analysis in dietary supplements (AOAC task force; FDA/NIH ).  Develop and write SOPs, Policies and the method protocols to be used in routine functions of the lab.  Validated HPLC/GC methods to analyze various nutritionally important food analytes, i.e.,tocopherols, tocotrienols, vit K, nutraceuticals, capsaicin, cholesterol & phytosterols. sugars, sugar alcohols etc.

1995–1997

Silliker Laboratories

Chicago Heights, IL

Research Manager  Managed Research Department.

 Developed and validated various new HPLC methods for analysis lactose, sugars, B-lactam antibiotics in milk, vitamin K analysis using post-column, derivatization, iodine by by ion-chromatography with PAD, amino acids analysis, hydroxy-citric acid, benzocaine, resorcinol, carotenoids, ginginosides, aspartamae and its degradatory products.  Participated in AOAC collaborative study on ethoxyquin.

1990–1995

Silliker Laboratories

Chicago Heights, IL

Method Development Specialist  Managed and supervised instrumental and vitamin dept.

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AOAC OMB MEETING MATERIALS

 Developed/validated various new HPLC methods for vitamins, preservatives, organic acids etc.  Participated in AOAC collaborative study on vitamin D analysis by HPLC.

1987–1990

Dept of Food Science & HN, Gainesville, FL

Postdoctoral Research Associate  Studied metabolism and bioavailabilty of folate vitamers in humans using stable isotopes analyzed using mass-spec.  Synthesized various stable isotopes of folates and purified using HPLC & characterized by photo diode array.  Studied Polyglutamyl conjugase from human intestinal brush border vesicles and from porcine pancreatic juice using a HPLC assay.  Devised various methods of folate extraction from biological tissues assessed using HPLC methods. 1986–1987 Dept of Pharmacology, LSUMC, Shreveport, LA Postdoctoral Research Fellow  Studied mechanism of folate transport in rat kidney. Characterized folate receptor in renal brush border vesicles.  Studied effect of ethanol on folate metabolism and bioavailabilty of folate vitamers in rat using radioactive isotopes. 1976–1986 Biochemistry Dept., MS University, Baroda, India Reader and Lecturer  Taught Biochemistry, Human Physiology and Clinical Chemistry, Human Nutrition and Food Chemistry to post-graduate students.  Studied effects of nutritional factors on intestinal enzymes and lipids.

1982–1983

Dept. of Pediatrics, AHSC, Tucson, AZ

UNESCO Postdoctoral Research Fellow  In vitro studies on sugar transport using everted gut sac technique and its correlation with activities of digestive enzymes.  Studies on thyroid hormone receptors in isolated intestinal epithelial crypt and villi cells.

1977–1980