Sulfites ERP New Member Book

AOAC INTERNATIONAL SULFITES EXPERT REVIEW PANEL

New Member Information (November 28, 2018)

AOAC INTERNATIONAL 2275 Research Blvd., Suite 300 Rockville, MD, 20850 UNITED STATES

dboyd@aoac.org 301.924.7077 x126

Sulfites Expert Review Panel As of: November 28, 2018

Oliver Ou, Ph.D. USDA FSIS LQAD 950 College Station Rd Athens, GA 30605 USA Tel. +1( 706 ) 308 0183 (O) Email: oliver.ou@fsis.usda.gov Term: November 28, 2018 – September 30, 2021 Tom Phillips MD Department of Agriculture State Chemist Section 50 Harry S Truman Pkwy Annapolis, MD 21401 USA Tel. +1( 410 ) 841-2754 (O) Email: tom.phillips@maryland.gov Term: November 28, 2018 – September 30, 2021 2275 Research Blvd Ste 300 Rockville, MD 20850-3250 USA Tel. +1(301) 927-7077 x157 (O) Fax. +1(301) 924-7089 Email: dmckenzie@aoac.org Term: November 28, 2018 – September 30, 2021 2275 Research Blvd Ste 300 Rockville, MD 20850-3250 USA Tel. +1(301) 927-7077 x133 (O) Fax. +1(301) 924-7089 Email: lphillips@aoac.org Term: November 28, 2018 – September 30, 2021 Deborah McKenzie, AOAC Staff Liaison AOAC INTERNATIONAL La’Kia Phillips, AOAC Staff Liaison AOAC INTERNATIONAL

Sneh D. Bhandari, Ph.D. Mérieux NutriSciences 3600 Eagle Nest Dr Crete, IL 60417 USA Tel. +1(708) 367-4628 (O) Email: sneh.bhandari@mxns.com Term: November 28, 2018 – September 30, 2021 Katherine S. Carlos, Ph.D. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition 5001 Campus Dr College Park, MD 20740 USA Tel. +1( 240 ) 402-1835 (O) Email: katherine.carlos@fda.hhs.gov Term: November 28, 2018 – September 30, 2021 George Joseph, Ph.D. AsureQuality Blockhouse Bay 131 Boundary Rd, Lynfield AUCKLAND 0600 NEW ZEALAND Tel. 64 9 62628237 (O) Email: george.joseph@asurequality.com Term: November 28, 2018 – September 30, 2021 Cheryl L. Lassitter NOAA - DOC, NMFS, NSIL 3209 Frederic St Pascagoula, MS 39567 USA Tel. +1( 228 ) 549-1737 (O) Email: cheryl.lassitter@noaa.gov Term: November 28, 2018 – September 30, 2021

Katerina Mastovska, Ph.D. Eurofins Food Integrity & Innovation 3138 Spring Mill Rd Plymouth Meeting, PA 19462 USA Tel. +1( 317 ) 371-2968 (O)

Email: KaterinaMastovska@eurofinsus.com Term: November 28, 2018 – September 30, 2021

AOAC INTERNATIONAL TERMS & CONDITIONS FOR EXPERT REVIEW PANELS (ERP) Please carefully read the following Terms and Conditions to serve as an AOAC Expert Review Panel (ERP) Member. This document contains important information about your obligations while reviewing candidate methods not currently adopted or published as an Official Methods of Analysis SM of AOAC INTERNATIONAL (OMA). 1. POLICIES & PROCEDURES FOR ERP MEMBERS: a. Must sign and submit AOAC Volunteer Acceptance Form (VAF) b. Must agree to adhere to AOAC’s policies and procedures :  Policy on Antitrust  Policy on Use of Association Name, Identifying Insignia, Letterhead, Business Cards  Policy on Volunteer Conflict of Interest  Official Methods of Analysis SM - Appendix G : Procedures and Guidelines for the Use of AOAC Voluntary Consensus Standards to Evaluate Characteristics of a Method of Analysis  Expert Review Panels – ERP Policies and Procedures 2. NON-DISCLOSURE & CONFIDENTIALITY: a. ERP members will not use or disclose to any individual or entity any proprietary or confidential information including, without limitation, technical data, research and development information, processes, product plans, methods or means, etc. b. All reasonable efforts shall be made to preserve the confidentiality of the information. 3. INTELLECTUAL PROPERTY RIGHTS: As an AOAC Expert Review Panel (ERP) member, you are granted access to candidate method(s) solely for the purpose of reviewing, deliberating and rendering a decision on the materials provided to you. a. Each candidate method remains the intellectual property of the method author until adoption as First Action Official Method SM status and the AOAC Copyright Authorization form has been signed and executed. Therefore, the information is distributed only to the vetted members of the respective ERPs. During ERP meetings, the candidate methods are provided for viewing only; no access will be granted to reproduce materials. b. Each candidate method adopted or published as Official Methods of Analysis SM of AOAC INTERNATIONAL becomes property of AOAC INTERNATIONAL upon execution of the AOAC Copyright Authorization form; however, additional supporting information and/or data are still the intellectual property of the method author. NOTE: Method Authors are encouraged to engage in the ERP process and attend the ERP meetings.

Restrictions on Accessing Candidate Methods: ERP Members are specifically restricted from the following without expressed written permission from an appropriate AOAC staff liaison. a. Reproducing b. Forwarding c. Distributing d. Discussing (without an AOAC staff liaison present) e. Divulging user ID/password 4. GENERAL & ETHICAL EXPECTATIONS: a. ERP Members can expect to have a minimum of three weeks to review methods prior to the ERP meeting.  You are requested to submit written reviews by a specified deadline. Please alert staff if you are unable to complete reviews on time.  You may be assigned individual methods or all the methods to review. Please be prepared to discuss your assigned methods during meeting.  You may use the OMA appendices as guidance for types of validation work that can be expected. If additional information is needed, please ask staff. b. ERP Meeting Quorum  A quorum is necessary to conduct business and is standard AOAC practice and required for official AOAC ERP meetings. If no quorum is reached, the meeting will not proceed and subsequently will be rescheduled.  Be considerate that your absence may impact the quorum of the ERP and its ability to have an official meeting to make decisions. Please alert staff as early as possible if you are unable to attend a meeting. c. ERP Consensus  ERP consensus may not reflect your own personal view.  There may be times when a method may not meet all the criteria exactly; however, the ERP may still choose to adopt the method. d. Respect for your peer ERP members and ERP Chair  Each member has been vetted for expertise relevant to the review of the candidate method(s) in the ERP. o Be considerate of each other’s perspectives and points of view. o Be considerate of the ERP’s consensus even if you disagree.  Notify staff and/or disclose in the ERP meeting if you have a direct or perceived conflict of interest for a specific method. o Please review AOAC’s policy on Volunteer Conflict of Interest.

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5. GUIDELINES FOR EXPERT REVIEW PANEL MEMBERS: a. Each ERP member has been vetted for the panel on perspectives and balance of the overall ERP based on the applicants which includes expertise and general knowledge of the subject matter. b. Must be able to attend ERP meetings. c. Must be able to complete assigned reviews in a timely manner. d. Must be prepared to speak on the candidate method, share reviews during the meeting and render a decision. e. Must be clear and concise when reviewing and provide justification on how additional recommended work is required for First Action Official Method SM status and requirement(s) for Final Action Official Method SM consideration. Recommendations may be provided, but not necessary. f. Focus on the science. g. Must be proactive in tracking assigned First Action Official Methods of Analysis SM of AOAC INTERNATIONAL . h. Must be able to assist in peer reviewing paper for publication.

__________________________________ Signature (Expert Review Panel Member)

___________________________

Date

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AOAC Expert Review Panels

An Orientation for the Meetings

Deborah McKenzie ʡʸ Sr. Dir., Standards & Official Methods SM AOAC INTERNATIONAL Staff Liaison - Official Methods Board

About OMA Methods

Must include safety precautions and warnings for any step or component used or that results from using the method

Should be written such that it can be used as written

Can be modified and/or extended to other applicabilities

Must be extremely detailed

Supporting Validation Data Required

Status of Official Methods

Basic Components of an AOAC Method

Sampling & Sample Preparation • Preparation of sample set • apportioning test portion(s) from the sample set

Isolation of Target Analyte(s) • Isolation of the target analyte(s) of interest from the testing portion matrix

Analysis of Target Analyte • Determination or Quantification • Detection and Confirmation • Identification and Confirmation

• Enrichment

and/or Extraction

Guide to Method Format

• Title • Applicability (SMPR can guide) • Principle – scientific premise of method • Apparatus (SMPR can guide) – types of technologies used and technology specifications • Reagents • Sample Preparation/Analysis/Determination /Preparation of Standard Solutions (may have subsections) • Calculations • References cited – including SMPR, guidance used, etc...

ERP Meetings ƒ ERPs will meet in person at a minimum of twice a year and up to four times per year: ƒ AOAC Mid-Year meeting (DC metro area) ƒ AOAC Annual Meeting. ƒ 2 additional designated times for proprietary method Organziational Affiliates ƒ At the ERP meeting: ƒ Reviews will be presented and a primary or secondary reviewer can make a motion/recommendation to the ERP whether or not to adopt the method as First Action OMA. ƒ ERP discusses the method. ƒ ERP renders a decision on First Action status. ƒ ERP renders decisions on modifications to First Action methods only. ƒ If the method is adopted ƒ ERP decides on what additional information is needed to recommend the method for Final Action status

ERP Teleconferences • Only after the initial in-person ERP meeting for First Action consideration of methods • Possible for some method modifications • Possible for First Action to Final Action ERP recommendations

ERP Meetings

Quorum

Presence of 7 vetted ERP members

Presence of 2/3 vetted ERP members

OR

WHICHEVER IS GREATER IF NO QUORUM, NO OFFICIAL MEETING

Method Review Overview

ƒ Method authors may be invited to make a presentation on their method ƒ REVIEWERS PRESENT THEIR REVIEWS AND MAY INITIATE A MOTION TO ADOPT THE METHOD IF THEY CHOOSE ƒ Chair recognizes each reviewer ƒ Primary and secondary reviews are presented.

ƒ If in favor, they may make and second a motion to adopt or not adopt the method ƒ Chair can then entertain discussion on themethod ƒ Chair can call for a vote once deliberation is complete

Consensus – First Action Adoption

ƒ First Action Official Methods status is granted:

ƒ Method must be adopted by unanimous decision of ERP on first ballot, if not unanimous, negative votes must delineate scientific reasons.

ƒ Negative voter(s) can be overridden by 2/3 of voting ERP members after due consideration.

ƒ Method becomes First Action on the date when ERP decision is made.

Consensus – First Action to Final Action

ƒ The ERP may then reach consensus on any additional information that it needs to review to be able to make a recommendation for Final Action Official Methods status.

ƒ This is a separate motion.

Road to First Action OMA Status

Methods may enter AOAC through standards with an active issued call for methods or by individual submission

Three modes of entry and (program administration)

(AOACI)

(RI/AOACI)

(AOACI)

Expert Review Panels will review all methods for all three modes of entry.

ERP Meetings – Review for First Action METHOD AUTHOR: present any method and any resulting changes to the method since submission for review, summary of SLV and/or reproducibility evaluation, any recognitions (from AOAC or external) and, final draft of method proposed for decision

ERP CHAIR & MEMBERS: present reviews and discuss any resulting issues or questions on the method, review and agree upon final draft of method proposed for decision, and chair calls for ERP decision in accordance to procedures.

CONSENSUS: Method must be adopted by unanimous decision of ERP on first ballot. If not unanimous, negative votes must delineate scientific reasons. Negative voter(s) can be overridden by 2/3 of non- negative voting ERP members after due consideration. Abstentions do not count towards vote; in case of multiple abstentions the results will need to be evaluated. Staff will monitor and record consensus voting.

STAFF: Will organize and coordinate meeting, record ERP actions and decisions, draft ERP report and distribute after chair approval, work with chair and OMB liaison to complete checklist and assemble recommendation package for OMB.

Motions to Articulate ERP Decisions for Candidate Methods

Decision Type

Motion

Adopting a Method* (method as is)

To move the candidate method to Official Methods SM First Action status (ERP can include limits to applicability, if substantiated) To move the candidate method for (modified applicability) to Official Methods SM First Action status To delay decision on the candidate method pending reconsideration and resubmission by the method author To approve the following recommendations to reconsider the method for Official Methods SM First Action status: • Requirements • Suggestions To send the candidate method back to the method author with information to method author that method requires further work at this time. To approve the list of requirements for the ERP’s consideration of the method for Final Action

Adopting a Method* (modified applicability) Not Ready to Adopt, (very promising) Recommendations as a follow up to the previous motion.

Not Ready to Adopt (Much work needed)

Requirements for ERP Final Action consideration

*Unanimous vote in favor of a motion required on first ballot. (see balloting rules)

ERP Methods Review & Approval

Methods should be scientifically sound with demonstrating that it will meet the needs of those using the method (evidenced by meeting the standard, or other acceptance criteria)

ERPs have approved methods with evidence of high potential to First Action and request additional work or support be submitted for review prior to ERP convening to recommend an action to OMB

OMB requires a justification or rationale for methods that are deemed acceptable and adopted but may not fully meet the standard set or acceptance criteria.

OMB Expectations for First Action

• Safety review needed prior to First Action status

• SLV type of supporting information available per the SMPR – Applicability, Method Performance Requirements Table, System Suitability, Reference Materials, and Validation Guidance • Comparison to SMPR – Documented method performance versus a SMPR – Document reasons for acceptability if method does not meet the SMPR

Publication of First Action Methods

ƒ Any approved method(s) along with supporting manuscript(s) and documentation must be sent to AOAC Publications after themeeting. 1. Method incorporating ERP revisions (preferably in AOAC Format) 2. Method Manuscript incorporating specified ERP revisions (in AOAC Format) 3. Signed AOAC Copyright Authorization form METHOD AUTHORS MUST SUBMIT THE FINAL APPROVED METHOD MANUSCRIPT TO THE JOURNAL OF AOAC INTERNATIONAL DIRECTLY Visit AOAC website for Instructions to Authors of Official Methods NO OMA NUMBER ASSIGNED UNTIL ALL DOCUMENTATION SUBMITTED

ƒ Method and method manuscript prepared for publication in the Official Methods of Analysis of AOAC INTERNATIONAL and in Journal of AOAC INTERNATIONAL

ƒ Updates on methods approved or status changes are published in the Inside Laboratory Management magazine and on the AOAC website

ERP Meetings – Method Tracking METHOD AUTHOR: present any method feedback obtained and any resulting changes to the method, any reproducibility information, any implemented ERP recommendations, final draft of method proposed for decision ERP MEMBERS: present any method feedback obtained and

discuss any resulting changes to the method, any reproducibility information, any implemented ERP recommendations, review and agree upon final draft of method proposed for decision, and make a recommendation to OMB. CONSENSUS: 2/3 vote in favor of a motion. Abstentions do not count towards vote; in case of multiple abstentions. Staff will monitor and record consensus voting.

STAFF: Will organize and coordinate meeting, record ERP actions and decisions, draft ERP report and distribute after chair approval, work with chair and OMB liaison to complete checklist and assemble recommendation package for OMB.

Motions to Articulate ERP Decisions for Official Methods at End of Tracking Period

Decision Type

Motion

Method ready to be recommended for Final Action status Method not being recommended for Final Action status or continuance of First Action status Method needs additional time in First Action status and ERP Tracking

To recommend method for Final Action Official Methods SM status

To recommend method for repeal from Official Methods SM status

To recommend method for continuance of First Action Official Methods SM status

2/3 vote in favor of a motion will pass the motion; otherwise the motion fails.

Documentation Needed

Method Safety Evaluation

Reference Materials

Evidence of Single Laboratory Validation or equivalent

Evidence of Reproducibility Assessment

Published First Action OMA

Method Performance versus SMPR or acceptance criteria

Final draft of First Action OMA to be considered for status update

Rationale or Justification for Repeal or Continuance of First Action OMA

OMB Meeting for Review of ERP Recommendations

OMB Review (renders decision on recommendation)

ERP Chair/or designee (addresses questions/comment)

OMB Liaison (presents recommendation)

Requirements for ERP Service

ƒ Must have demonstrated expertise in the method, technology, analyte/matrix, etc… Be a subject matter expert. ƒ Must be able to attend ERP meetings ƒ Must be able to complete assigned reviews on time ƒ Must be prepared to speak on the method and share reviews during the meeting ƒ Must be proactive in tracking assigned First Action Official Methods ƒ Must be able to assist in peer reviewing paper for publication ƒ Must sign and submit AOAC Volunteer Acceptance Form ƒ Eligible to serve as a Volunteer Expert in the PTM program

General Expectations for ERPs • You can expect to have a minimum of three weeks to review methods prior to ERP meeting. – You are requested to submit written reviews by specified deadline. Please alert staff if you are not able to complete on time. – You may have individually assigned methods to review or all of the methods to review. Please be prepared to discuss these methods during meeting. – You may use the OMA appendices as guidance for types of validation work that can be expected. If additional information is needed, please ask staff. • ERP Meeting Quorum – If there is no quorum, there is no official meeting. Please alert staff as early as possible if you are not able to attend a meeting. • ERP Consensus – ERP consensus may not reflect your own personal view – There may be times when a method may not meet all of the criteria exactly; however, the ERP can adopt the method. Ethical Expectations of AOAC Expert Review Panel Members • Respect for your peer ERP members and chair – Each member has been vetted for expertise relevant to the review of the method(s) in the ERP • Be considerate of each others perspectives and points of view • Be considerate of the ERP’s consensus even if you disagree – Inform staff as early as possible if you cannot attend the scheduled ERP meeting • Be considerate in that your absence can impact the quorum of the ERP and its ability to have an official meeting to make decisions – Notify staff and/or disclose in the ERP meeting if you have a direct or perceived conflict of interest for a specific method • Please review AOAC’s policy on Volunteer Conflict of Interest

Ethical Expectations of Expert Review Panel Members (con’t) • Respect for Method Authors and Intellectual Property – Each Method Author is encouraged to attend the ERP meeting – Each candidate methods (not yet adopted or published as Official Methods of Analysis of AOAC INTERNATIONAL ) are still the intellectual property of the method author. Therefore, the information is shared only with the vetted ERP members and is available during the meetings. Please do not distribute the information without expressed written permission from an appropriate AOAC staff liaison. – Be clear about and justify how additional recommended work is a requirement for First Action, a requirement for Final Action consideration, or something recommended, but not necessary. – Keep your focus on the science

Roles and Responsibilities

AOAC Official Methods Board Vet and approve stakeholder panel chair & voting members Vet and approve ERP membership and AOAC Experts Render decisions on status of First Action methods (Final Action, repeal, etc…) Assign a liaison to each stakeholder panel and ERP Coordinate OMB Awards AOAC Expert Review Panels Review methods and meet in person to render decisions on methods for First Action Official Methods SM status. Track First Action Official Methods SM and modify, if necessary Recommend First Action methods after 2 years or less to OMB for Final Action, continuance, or Repeal Participate in Consulting Service and PTM reviews for OMA and harmonized PTM and harmonized OMA method studies AOAC Experts Review and approve PTM validation testing protocol documentation Peer review of PTM validation manuscript and supporting documentation AOAC Research Institute - PTM Expert Reviewers Peer Review of PTM validation manuscripts and supporting documentation

AOAC Research Institute Independent Laboratories Conduct independent evaluation of candidate method using AOAC approved testing protocols AOAC Stakeholder Panels Develop voluntary consensus standards Assign working groups to draft standards method performance requirements Voting members demonstrate consensus on behalf of stakeholders AOAC Staff Coordinate method reviews and method approval activities Coordinate OMB meetings Provide trainings and orientations Maintain website and communication Document and publish actions and decisions Coordinate standards development activities Publish standards and methods AOAC Research Institute Technical Consultants Draft validation protocols in Consulting Service for assigned methods Facilitate PTM evaluation of assigned candidate methods Facilitate comments/responses for assigned OMA reviews

Questions?

Contact Deborah McKenzie at dmckenzie@aoac.org

Thank you. -