AOAC SPIFAN Vanillin Working Group (December 13, 2022)

AOAC Stakeholder Program on Infant Formula and Adult Nutritionals

VANILLIN WORKING GROUP MEETING

Tuesday, December 13, 2022

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

dboyd@aoac.org 301.924.7077 x126

ACCESS TO AOAC BYLAWS, POLICIES & PROCEDURES, AND STRATEGIC PLAN AOAC INTERNATIONAL Bylaws ( 11 -202 2 ) 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 chair-elect , 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.

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 (updated 8/2020) 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

AOAC INTERNATIONAL Strategic Plan

Vision

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

Mission

AOAC INTERNATIONAL ensures the safety and integrity of foods and other products that impact public health by convening government, industry and academia to develop and validate standards, methods and technologies.

Goals

Provide analytical solutions to current and emerging issues through standards development and trusted measurements. Attract and retain members and stakeholders through education, mentoring, networking and collaboration to grow and strengthen the association. Build and cultivate relationships to identify strategic opportunities for collaboration. Develop new and improve existing processes, products and services. Identify, strengthen, and grow revenue streams, while continuously optimizing resources, to ensure the association’s long-term success. Advance an effective leadership culture that promotes accountability among members and staff.

Analytical Excellence

Engagement

Partnerships

Core Programs

Sustainability

Governance

December 10, 2019

REQUIREMENTS FOR ERP SERVICE  Must have demonstrated expertise in the method, technology, analyte/matrix, etc… Be a subject matter expert.  Must be able to attend ERP meetings  Must be able to complete assigned reviews on time  Must be prepared to speak on the method and share reviews during the meeting

 Must be proactive in tracking assigned First Action Official Methods  Must be able to assist in peer reviewing paper for publication  Must sign and submit AOAC Volunteer Acceptance Form  Eligible to serve as a Volunteer Expert in the PTM program

ETHICAL EXPECTATIONS FOR ERP 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 other’s 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 • 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

CANDIDATE METHOD REVIEWS  In your judgment, does the method sufficiently meet the Standard Method Performance Requirements (SMPR) or community ‐ based guidance?

 In your judgment, is the method scientifically sound and can be followed?  In your judgment, what are the strengths and weaknesses of the method?

 In your judgment, how do the weaknesses weigh in your recommendation for the method?  In your judgment, will the method serve well the stakeholder community that will use the method?  In your judgment, is the method/manuscript in AOAC format?  In your judgment, what additional information may be needed to further support the method meeting the SMPR or community ‐ based guidance?  Members of both Committee on Safety and Committee on Statistics serve as advisory resources for all ERPs

ERP MEETING QUORUM AND CONSENSUS VOTING MEETING QUORUM ERP Meeting Quorum is seven (7) vetted members of the ERP OR 2/3 of the total vetted ERP, WHICHEVER IS GREATER. NO QUORUM, NO MEETING.

POTENTIAL MOTIONS BY ERP FOR CONSENSUS ON METHODS Consensus Decision Motion Adopting a 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 and 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 that the method requires further work and cannot be considered 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 (but very promising) Recommendation as a follow up to the previous motion Not Reay to Adopt (much work is needed) Requirements for ERP Recommendation for Final Action

Each Motion will require a second and a vote by the ERP. * 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.

OTHER CAVEATS AND INFORMATION:

Circumstance

Resolution

Method authors and those affiliated with the method under review may be eligible to serve on the ERP

He/She/They must reveal their direct or perceived connection and/or conflict of interest to AOAC staff and the ERP. It is acceptable to recuse oneself and abstain from voting. ERP members of the same affiliation have only one (1) vote counted. Serves as a resource. Members of the Committees on Safety and Statistics also serve as a resource to both the ERP and method authors. Method authors will be invited to recommend three (3) ERP members to conduct peer review of the manuscript.

More than one ERP member may have the same affiliation

Official Methods Board will assign a member to be a liaison to the ERP ERP members may participate in the peer review process of the manuscript publication

I. General Guidelines Below is the general format of manuscripts with Official Methods or candidate Official Methods for ERP review and AOAC Publications.

A. Before the Method

o Title of the Manuscript o Author names and Affiliations o Abstract o Introduction o Summary of Validation Study Design or Protocol used. B. Method (See section II for the Formatting of Methods in Manuscripts)

C. After the method o Manuscripts should include the following sections: Results and Discussion, Conclusions, Acknowledgments, and References. II. Format and Style for Official Methods The Method portion of the manuscript should be included after the Introduction. Methods must include the following elements: Title of the Method The title should include the Method number, analyte, matrix, technology used and the official status. AOAC will provide the Official Method number after the paper is received for publication as such, authors should use the following 2020.xx

Example:

AOAC Official Method 2020.xx Analyte in Matrix Technology used First Action 2020 (use the year that the method was approved)

Applicability statements Applicability statements should include the list of matrix(es) along with specific matrix types and range or limits of determination or detection. Applicability statements should address utility and limitations on use of method or other information. [Applicable for determination of ….] Caution Statements List any statements of caution after the applicability section. Review all methods for potential hazards. Authors should automatically incorporate safety statements. Decisions regarding inclusion of caution statements should be practical; overuse will be self ‐ defeating. Methods that create toxic, obnoxious or environmentally hazardous fumes and wastes should contain practical directions for disposal. Specify precautions and possible hazards in carrying out method, including safety information on equipment, techniques and practices, and safe handling of chemicals, acids, alkalies, microorganisms, and solvents. Example: Caution: Refer to the material safety data sheets for all chemicals prior to use. Use all appropriate personal protective equipment and follow good laboratory practices. Performance Parameters Include statistical data if the study provides sufficient information with regard to the reliability of the method. All headings should be set in Alphabetical Order i.e., A. Principle, B. Apparatus, C. Reagents. Methods should be laid out in the following order: A. Principle

Explains scientific premise on which the method is operates specifically the mechanism of the analysis. Explain the purpose of various steps or the basis of unfamiliar or unusual reactions. Include the scope and sensitivity of the method—its applicability to certain types of samples and its non ‐ applicability, because of interference, solubility, or other reasons, to other types of samples. Methods are divided into several descriptive sections i.e., Apparatus, Reagents, Reagent Preparation, Standard Preparation, Sample Preparation, Extraction . The sections should include specifications for necessary laboratory apparatus and reagent preparations. See also Definition of Terms and Explanatory Notes . NOTE: Official Methods will need to include InChi numbers and CAS numbers where appropriate. B. Apparatus Lists the equipment that requires assembly or that has specifications critical to the method performance. Describe equipment in terms of performance characteristics. List the necessary laboratory apparatus. For more information see “ Definition of Terms and Explanatory Notes ” Apparatus should be set as in the following example: (a) Ultra ‐ HPLC (UHPLC) system —Nexera (Shimadzu, Kyoto, Japan) or equivalent LC system consisting of a dual pump system, a sample injector unit, a degasser unit, and a column oven. (b) Triple ‐ quadrupole mass spectrometer —Triple Quad 6500 (Sciex, Framingham, MA) or equivalent tandem MS (MS/MS) instrument. (c) Column —Kinetex C18 core ‐ shell, 2.6 μ m, 2.1 × 50 mm (Phenomenex, Torrance, CA) or equivalent. C. Reagents Do not list common reagents which would ordinarily be expected to be available in a well ‐ equipped analytical laboratory. Reagents without specifications are automatically reagent grade, conforming to the specifications of the American Chemical Society (ACS) when such specifications exist. Reagents should follow the same format as in the above example under Apparatus. D. Reagent Preparation, Standard Preparation, Sample Preparation, Extraction Sections Use these sections for materials requiring directions for preparation, purification, or standardization. Standard compounds will often need specifications or a source of supply. The sections should use the same style and format as in the above example under Apparatus. E. Determination If a method is fairly straight forward or consists only of a single major step, describe all operations under this heading. If the method is complex, however, divide the determinative section into several parts which may be characterized by the type of operation performed. Be sure to identify all critical control points. F. Calculations Include calculations in a method for convenience to avoid the need for looking up factors and deriving equations, particularly when a series of multiple dilutions or aliquots are used at various steps in the method. Take particular care to ensure that there is no ambiguity with regard to the entries in the numerator and the denominator. G. Data Handling A section on data handling should be included if necessary. Example : Report results as μ g/hg to one decimal place or as IU/hg to zero decimal places. Other sections may be included as needed and should be labelled in alphabetical order (i.e., H. Chromatography) Tables and Figures Tables and Figures should be in separate documents and clearly labelled. Do not intersperse tables and figures within the text document. Tables and figures should be numbered consecutively as Table 1, Table 2, Figure 1, Figure 2. For instructions on how to layout Tables and Figures specifications please visit our Instructions to Authors page. Supplemental information Supplemental information is allowed and should be included as a separate Word document clearly labelled. Supplemental information should be cited in the text. Supplemental data may include large tables, figures or appendices. Please note: this information will be available on the online Journal site and will be uploaded as submitted. It will not be copyedited or typeset.

Detailed Author Instructions for Each Section of Manuscript Including Tables and Figures Please follow these instructions closely; doing so will save time and revision. Note: if the instructions are not followed and the paper is accepted the Editorial Office will return the paper to the author and the instructions will need to be followed before production and publication can begin. If the Section Editor sends notification to author that changes are necessary, it is the author’s responsibility to upload updated files per Section Editor’s comments before approval is granted. 1. Write in clear, grammatical English. 2. Double space all materials. Do not right justify or use proportional spacing; avoid hyphenation. 3. Suggest at least three qualified reviewers (i.e., Expert Review Panel members). Text Please send manuscript text as a Word file. Tables and figures should set as separate files clearly named (i.e., table 1, table 2, figure 1, figure 2 etc.). DO NOT intersperse tables and figures in text. Choose a title that is as descriptive of the paper’s content as possible. Do not try to make the title clever or “catchy.” Use specific terms that will serve as index entries; information services increasingly rely on titles for indexing. Avoid the use in the title of symbols, formulas, and terms that must be defined. Contact AOAC staff in Standards and Official Methods SM or in Publications for style suggestions for method manuscripts if needed. 2. Author information Give the full first name, middle initial, and surname of each author. Do not include academic titles. List the affiliation(s) of the author(s) in a form that will serve as a complete mailing address, including zip code. The corresponding author needs to be identified and e ‐ mail address supplied. Use the affiliation at which the work was performed; if authors have moved to a different affiliation or if any of the authors have moved to a different address, give the address in a footnote, indicated by a superscript Arabic numeral. It is generally assumed that all persons listed as co ‐ authors of a paper or report have made substantial contributions to the work reported. Other supplemental information should be moved to Acknowledgements i.e., supported by a grant or contract, taken from a thesis or dissertation, publication authorized by an institution, or part of the institution’s publication series. 3. Abstract 250 words. Provide specific information, not generalized statements; abstracts must be organized and include the following subheads: Background, Objective, Methods, Results, Conclusions, Highlights. 4. Introduction Include a statement of the purpose of the work, together with enough background to enable the reader to attain the proper understanding and perspective. State the use of the compound being discussed. Cite the work of others which contributed directly to the present paper but do not attempt to survey the entire literature of the field unless the paper is intended to be a review. Consider the following hypothetical questions in deciding what information to include in the introduction: Why was the work done? Why was a method needed? Did any methods exist previously, and if so, why were they not suitable? If a new method had to be developed, upon what established chemical, biological, or physical principles was it based? What general approach was used? Format and Style 1. Title

If an interlaboratory study is being reported and a background report has already been published, do not repeat all the introductory material; instead, cite the earlier report and go directly to the description of the interlaboratory study. 5. Study Design Include the type of study(ies) that were conducted including, Collaborative Study, Single Laboratory Validation, etc. Include a section sub ‐ heading for each type of study used to develop data in the validation of the method written in the paper with a brief description of the study, and samples used. Do not include the results, just a summary of what was done to evaluate the method and collect the data. Include any notable procedures in the study design. 6. Method Consult section II (Format and Style for Official Methods of Analysis) and section D of this Guide on preparing methods. Follow these general principles: Write the method in imperative style (“add 10 mL”; evaporate the solution to dryness,” instead of “10 mL was added;” “the solution was evaporated to dryness”). Place important reagents and apparatus in separate sections (or combine them into one separate section) before the actual determination; indicate specifications, source of supply, and instructions for preparation of working solutions where pertinent. List, each reagent or piece of apparatus as a separate item. Provide enough detail so that the reader can repeat the method if he wishes, and indicate how the results are to be calculated, if a calculation is required. 7. Results/Discussion Discuss the results fully enough so that their significance is evident, and conclusions can be drawn from them, but do not use the Discussion merely to repeat data that are given in tables and figures. Provide a statistical treatment of the data if an interlaboratory study has been conducted and where appropriate in other reports and papers. Indicate whether certain data have been rejected and name the statistical test which was the basis for rejection. Try to provide an explanation for unexpected results if possible or, if you cannot explain them, state this fact. In general, do not present the same quantitative data in both a table and a figure in the same paper, because this is expensive and a waste of journal space and money; choose one form or the other. (The exception to this rule is Youden’s diagrams.) Although it is difficult to generalize consider using figures where trends or relationships are especially important and using tables where individual results should be reported, e.g., interlaboratory studies. If a method is being studied, give both recovery data obtained on known samples (usually prepared by the author) and results on unknown samples of the type encountered in regulatory work. Except in unusual cases, do not include straight ‐ line graphs; instead, state in the text the curve is linear in the range of interest. Cite tables and figures consecutively in text with Arabic numerals. 8. Acknowledgments Give brief thanks (no social or academic titles). Financial aid should be acknowledged in this section. 9. References Submitted papers or unpublished oral presentations may not be listed as references; cite them in text as unpublished data or personal communications. Cite all references to previously published papers or papers in press in numerical order in text with number in parentheses on ‐ line (not superscript). List references numerically in References in exactly (arrangement, punctuation, capitalization, use of ampersand, etc.) the same styles of examples shown below or see recent issue of the Journal for less often used types of entries. Follow Chemical Abstracts for abbreviations of journal titles.

10. Tables and Figures Tables

Tables should be supplied in an editable format (e.g., Microsoft Word), not as an image file. Avoid excessive formatting and the use of tabbed spacing to indicate alignment and ensure that any formatting or superscript symbols such as asterisks are explained in the table footnote. Unless the journal’s house style indicates otherwise, provide units in column or row headers, rather than in the table body. Consider the size and layout of the printed journal (or online PDF) when deciding on the dimensions of your table. All tables provided should be cited within the article text. Figures Each figure should be submitted as its own file. Supply figures at the intended print size. Resolution at this size should be no less than 300dpi for halftone images, 600dpi for composite images, and 1200 dpi for line art, and at no less than 1080px width. For typical print page sizes please visit https://academic.oup.com/journals/pages/authors/preparing_your_manuscript . The dimensions of the printed journal or online PDF should also be considered when choosing figure layout, to minimize white space when reproduced at the intended size. Most standard figure formats are acceptable, but .tiff is recommended for halftone and composite images, .eps for line art and vector graphics. Images embedded into Microsoft Word are often not good quality. Images created with multiple layers should be flattened to a single layer prior to submission. Multi ‐ paneled figures should be supplied as a single file with each panel lettered clearly, according to journal style. Avoid placing letters over shaded areas if possible. Miscellaneous Abbreviation for liter is L; abbreviation for micron is μ . Do not italicize common Latin expressions such as et al. and in vitro; for nomenclature of spectrometry, gas chromatography, and liquid chromatography, follow practice of American Society for Testing and Materials. Do not use numbering in your headings or subheadings. Major headings should be set in bold font, secondary

headings in italic font, and third level headings should be set using alphabetical lists (a) . The Journal prefers the use of the front solidus (/) do not use superscript ‐ 1 (i.e., μ g/kg).

Footnotes Avoid use of footnotes to text.

Special Instructions for Journal Articles containing Official Methods of Analysis First and Final Action Methods First and Final Action Official Methods will need to include InChi numbers and CAS numbers where appropriate. Additional Author Guidelines For additional information on manuscript preparation please visit the Oxford Academic website at: https://academic.oup.com/journals/pages/authors/preparing_your_manuscript

Management of interpretation function

会 议 开启后，您可以按您的需要 选择语 言，建 议 勾 选 “ 将原始音 频 静音 ”. Simultaneous Interpretation is available. You can click "interpretation" on the control panel of the webinar. Select the language you want to listen to. Suggest to select: “Mute Original Audio”

AOAC INTERNATIONAL Stakeholder Programon Infant Formula and Adult Nutritionals (SPIFAN) Meeting in Conjunctionwith AOAC China Section VANILLIN WORKING GROUP MEETING DRAFT AGENDA Tuesday, December 13, 2022 Meeting Time: 7:00AM-8:20AM (Eastern Time) SPIFAN Chair: Mr.Darryl Sullivan Chief Science Officer (Eurofins Food Integrity and Innovation) Dr. Cheng-Zhu Liang President, AOAC China Section (Technology Center of Qingdao Customs) I. WELCOME & INTRODUCTIONS (Sullivan – 7:00AM-7:10AM) Mr. Darryl Sullivan (Eurofins) will call the meeting to order. Participants will review the AOAC policy documents and draft meeting agenda. II. OPENING REMARKS FROM DR. LIANG - AOAC CHINA SECTION PRESIDENT (Liang – 7:10AM 7:20AM) Dr. Liang Cheng-Zhu (Technology Center of Qingdao Customs) will provide opening remarks for the meeting. III. OVERVIEW OF AOAC STANDARDS PROCESS (McKenzie – 7:20AM-7:30AM) Ms. Deborah McKenzie (AOAC) will provide a brief overview of the AOAC Standards Development process. IV. WORKING GROUP PRESENTATION & DISCUSSION: VANILLIN (Working Group Co-Chairs, Draher/Jing – 7:30AM-8:15AM) Dr. Jonathan Draher (Abbott Nutrition) & Dr. Xiao Jing (CFSA) will present an overview of current methodology, regulatory landscape, and analytical background information including technologies.  Draft Fitness-For-Purpose Statement  Discussion on draft Standard Method Performance Requirement (SMPR) CLOSING REMARKS (Liang/Sullivan – 8:15AM-8:20AM) Dr. Liang Cheng-Zhu & Darryl Sullivan will provide closing remarks of the Vanillin Working Group meeting. V.

* Requires a vote **Draft meeting agenda is subject to change w/out notice

Version 2

STAKEHOLDER PANEL ON INFANT FORMULA AND ADULT NUTRITIONALS (SPIFAN)

Darryl Sullivan, Chief Scientific Officer, Eurofins US AOAC SPIFAN Stakeholder Panel & ERP Chair

Darryl Sullivan is the Director of Industry and Regulatory Affairs for the Food Integrity and Innovation Division of Eurofins. Mr. Sullivan acts as the primary liaison with food, nutritional and dietary supplement companies as well as providing expertise on designing comprehensive testing programs to meet scientific and regulatory requirements. In this role he is often called upon as an

expert witness for litigation and dispute resolution. He has managed numerous different departments at Covance including lab operations, research and development, client services, sample management, sample preparation and study direction, as well as a satellite laboratory in Michigan. Mr. Sullivan received his BS from the University of Wisconsin-Madison and has more than 35 years of experience in laboratory testing of food and dietary supplements. He is considered to be an expert in the field of validation of analytical methods, having served for three years as Chair of the AOAC INTERNATIONAL Official Methods Board. Mr. Sullivan was a member of the Task Force that redesigned the AOAC Standards Development Process. He is currently the Past President and Secretary of the AOAC INTERNATIONAL Board of Directors, and the Chair of the AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals. He is also the Chair of the AOAC Stakeholder Panel on Dietary Supplements. He is a former member of the Board of Directors of the AOAC Research Institute. Mr. Sullivan is the Chair of the IFT Nutraceutical and Functional Foods Division. He is the Chair of the Analytical Laboratories Committee of the American Herbal Product Association, a member of the USP Expert Committee for Dietary Supplements, and is a member of the Joint Committee on Dietary Supplements of NSF. He is a member of the CRN Regulatory Affairs Committee and the NPA ComPLI Committee. Mr. Sullivan has developed and validated hundreds of analytical methods in the areas of nutrient and residue testing, and is the author of more than 75 publications and 100’s of scientific presentations. In addition, he is the Past Chair of the AOAC Presidential Task Force on Dietary Supplements and co-editor of the book Methods of Analysis for Nutrition Labeling. He is also the co-editor of the book Improving Import Food Safety.

STAKEHOLDER PROGRAMON INFANT FORMULA AND ADULT NUTRITIONALS (SPIFAN)

Chengzhu Liang, Ph.D. Director of Technology Center Qingdao Customs, P. R. China AOAC China Section President

Liang is serving as President of AOAC China Section, member of the Standing Committees on Analytical methods for Composi t ion and Harmonization of Microbiological Methods of ISO/IDF, the member of the National Food Safety Standards (GB) Review Committee, the graduate student tutor of Ocean University of China.

Liang drafted 3 international standards, 10 national standards and 30 industry standards. He has 15 authorized national invention patents. He published more than 30 research papers in SCI and core journals. He edited and published 10 professional books. Liang was responsible for the follow-up evaluation of national food safety standard, which entrusted by China National Center for Food Safety Risk Assessment. Under his leadership, the team completed the follow-up evaluation of 256 national food safety standards and the comparative study of 20 national standards with AOAC/ISO international standards. He submitted more than 30 proposals for the formulation and revision of national standards. Since 2011, Liang has organized conferences of AOAC China Section every year. He helped strengthen the communication between AOAC international standards and Chinese national standards. He has made positive contributions to the internationalization of Chinese standards and the introduction of AOAC and other international standards into China.

AOAC WORKING GROUP ORIENTATION

AOAC Stakeholder Program on Infant Formula and Adult Nutritionals

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About AOAC Stakeholder Program on Infant Formula and Adult Nutritionals (SPIFAN) • Historical Perspective • AOAC infant formula methods were validated in 1980s • New formulas exposed some gaps in validated methods • Infant formula is highly regulated around the world • Regulatory agencies use AOAC methods • SPIFAN Formed in 2010 • AOAC established the SPIFAN to develop the voluntary consensus standards • Identified gaps in methods used to analyze label nutrients in infant formula • Created 48 AOAC voluntary consensus standards for nutrient methodology for infant formula and adult nutritionals • Evaluated and recommended most reliable methods

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GOALS OF AOAC SPIFAN

 A funded, multi-year integrated science program for infant formula and adult to coordinate all future consensus-driven needs development, validation and implementation of methods for the analysis of a wide range of nutrients associated with infant formula and adult nutritionals.

 Standard method performance requirements  Updated guidance for method validation

 Incurred and Testing Materials  Proficiency Testing Program  International Engagement  AOAC Sections  ISO and IDF along with other SDOs  Codex Alimentarius

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ENGAGEMENT, HARMONIZATION AND PROGRAM INTEGRATION Forum to review new technologies and emerging issues

Engage global partners,

Advocate Global acceptance and use of SPIFAN methods

harmonize standards

Update AOAC Official Methods of Analysis

Develop Standards and adopt Methods

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ABOUT THE WORKING GROUP

SPIFAN Vanillin Working Group

Standard Method Performance Requirements (SMPRs)

• Jonathan Draher (Abbott) • Xiao Jing (CFSA) Co-Chairs:

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AOAC SPIFAN STRUCTURE

SPIFAN Testing Materials

Advisory Panel

Xiao Jing (CFSA) Jonathan Draher (Abbott)

Vanillin

Standards - WGs

Darryl Sullivan

47 WGs for SMPRs

Staff

Nutrient Methods

Whey Protein: Casein

Official Methods SM Program - ERPs

Residues

AOAC Science Team

Taskforce

MCPD

Laboratory Proficiency Testing

IF01 PT Program

Contaminants

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Working Group Responsibilities  Working group chairs will be responsible to: o Launch the working group activities • Review Relevant AOAC and Program Information • Develop Launch presentation • Provide presentation of final product • Lead reconciliation of comments • Moderate WG meetings • Provide summaries and track documentation updates • Follow AOAC processes and procedures

 Working group members will be responsible to: o Active Participation • Participate and be prepared for WG meetings • Be willing to lead or participate in subgroups • Engage in online collaboration • Assist WG chairs in moving work forward • Follow AOAC processes and procedures

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STANDARDS AND CONSENSUS PRODUCTS

• Transparency • Openness • Balance of Interests • Due Process • Consensus • Appeals Basic Principles

Integrating AOAC Consensus Products

• Performance Requirements • Guidelines • Sampling Standards • Methods of Analysis • Best Practices • Operational Documents • Reference Materials • Training

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STANDARD METHOD PERFORMANCE REQUIREMENTS (SMPRS)

 Documents a community’s analytical method needs.  Very detailed description of the analytical requirements and parameters.  Includes method acceptance requirements.  Used to adopt AOAC Official Methods by Expert Review Panels.  Published as a standard in the OMA and status changes in the AOAC Inside Laboratory Management (ILM)

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Example SMPR: Selected Food Allergens

Specified intended method use

Performance parameters and targets that method must meet

How the method is to be applied

Commodities from which the method should

be able to determine allergenic targets

Definitions used for this SMPR as it relates to the method

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AOAC SMPR OVERVIEW

Method Performance Requirements

Other Details - Public review and comment period - Questions resolved by WG chair - Approval by Stakeholder Panel

Stakeholder Panel

Applicability Statement

Definitions

Could include: analytical range, LOD, LOQ, repeatability (RSDr), recovery, reproducibility (RSDR)

Currently 48 approved SMPRs (https://www.aoac.org/resources/?topic=&type=SMPR&key=SPIFAN)

• Drafted by the SPIFAN working groups; • Approved by consensus of SPIFAN • Published in the Official Methods of Analysis of AOAC INTERNATIONAL

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VERY BASIC AOAC PROCESS

Program/Project Scope Defined for Period of Time

•ASF Emerging Challenge/Technology •Individual/Sole Source

•Working Group draft standands •Draft standards receive input from all interests until consensus is achieved

•Advisory Panel formed by program/project sponsors •Working Group Chairs and Science Advisor(s) assigned as needed

New Program/Project Formed

Standards Developed

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BASIC AOAC STANDARDS DEVELOPMENT ACTIVITY FRAMEWORK

Advisory Panel Meeting

Community Consensus

WG Meetings

Works with AOAC to define scope of work to be launched, including development of new programs and/or new working groups (WGs)

WG begin work and draft consensus documents via web conference and reach general consensus on draft standard between AOAC meetings

WG chair(s) present final draft standard along with reconciled comments for deliberation and consensus.

Approval of Standard follows consideration of all input and with oversight by Official Methods Board (OMB). Publication of Standard is in the OMA Approval/Publication of Standard

Draft standard is posted for public comments. Comment period is ≥ 30 days Virtual public comment session via webconference Draft Standard Public Comment Period

At AOAC meetings, launch WG effort by refining a preset scope of work into a basic applicability statement from which the WG to began drafting the standard (e.g., SMPR, guidelines, etc) Launching New WG Activities

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Public Comments

Facilitate online public forum

Reconcile Comments

Post “Call for Comments” to general public

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Additional Duties

Assist Method Authors

Provide guidance to methods in use

Identify experts

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Tentative Timelines

PREPARE WORKING GROUP PRESENTATIONS - Launch Presentations AOAC Outreach and notification of new AOAC GFAP standards activities AOAC Calls for Working Group Members December 2022

PUBLIC COMMENT PERIOD – written and online (potentially) March 2023–April 2023

FINALIZE VERSIONS VALIDATION GUIDANCE AOAC OMB REVIEW AND PUBLICATIONS May 2023 – June 2023

COMMENT RECONCILIATION & finalize guidance drafts AOAC SPIFAN Community Consensus – SMPR Presentation April 2023 – May 2023

WORKING GROUP MEETINGS –Draft Standard Method Performance Requirements (SMPRs) Development January 2023 – March 2023

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13 December 2023 – Working Group Orientation

SCHEDULING OF WORKING GROUP MEETINGS

WG meetings and offline collaborations are scheduled in conjunction with the working group co-chairs

All meetings conducted using Zoom All meetings scheduled in ET

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AOAC SPIFAN SMPRs and OMA, Appendix L

RESOURCES FOR WORKING GROUPS

Official Methods Board guidance

•OMA, Appendix F

AOAC Core Programs and Services

•Standards & Official Methods and Performance Tested Methods programs •Technical Division on Reference Materials Community Email Blasts

Program updates, upcoming meetings, related activities, announcements, etc…

Your expertise and volunteer service

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WORKING GROUP COLLABORATION

 Outside of scheduled WG meetings  MS SharePoint Site  MS Teams  Email (if necessary)

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Be prepared for WG meetings

TIPS FOR SUCCESSFUL WORKING GROUP OUTCOMES

Be cooperative and respectful of WG chair and WG colleagues

Be active and willing to participate and collaborate

Alert staff should you have any questions

If you know of expertise that should be included in the WG, please alert the WG chair and staff.

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PEOPLE RESOURCES

 Vanillin WG Collaboration  Dr. Jonathan Draher (Abbott) – WG co-chair

 Dr. Xiao Jing (CFSA) – WG co-chair  Darryl Sullivan – AOAC SPIFAN Chair  Chengzhu Liang – AOAC China Section President  Dr. Lei Bao – Liaison

 Staff Resources  Delia Boyd – Sr. Manager, Standards ( primary contact for WG )  Deborah McKenzie – Sr. Director, Standards  Alicia Meiklejohn – Director, Governance & Business Development

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DOCUMENT STAGES OF THE AOAC STANDARDS DEVELOPMENT PROCESS

STAGE 1: Project Initiation: Agreement and alignment on goals and scope of work for the type of standard to be developed and key experts, leading authorities, and stakeholder organizations that should be involved. Outreach and engagement about upcoming standards development activities. This stage includes assessing interested stakeholders and working group members for balance of interests. An OMB liaison is also assigned at this stage. This stage encompasses Detailed Steps 1 and 2. STAGE 2: Working Group Draft Standard: Working group onboarding, launching, and developing draft standard that can be posted for public comment and additional stakeholder input via working group consensus. Working groups meet as often as needed to achieve consensus with allowance for working group members to express objections and appeals and have those views considered before the WGDS is ready for posting for public comment. This stage includes the public comment period. This stage encompasses Detailed Steps 3 and 4. STAGE 3: Reconcile comments and Revision of Working Group Draft Standard: Working group review and reconciliation of written and oral comments received. The WGDS is revised as needed based on the reconciliation of the comments and input. The working group shall review draft with allowances for working group members to express objections and appeals and have those views considered before reaching consensus on the document. Working group consensus makes the revised draft a Working group Draft Standard – Revision 1. This stage includes preparing the WGDS ‐ R1 for presentation to a stakeholder assembly for consensus. This stage encompasses Detailed Step 5. STAGE 4: Stakeholder Assembly Consensus Draft Standard (SACDS): WGDS ‐ R1 is presented to the stakeholders with public comments reconciliation. Stakeholders deliberate on acceptability of the draft standard and may include any tweaks/clarifications that might be needed to the draft standard. Stakeholders may reach consensus to accept a final version of the document, an SACDS, or make recommendations to revise the draft. This stage encompasses Detailed Step 6. STAGE 5: Due Process Audit Review: OMB to review the outcomes of the stakeholder assembly consensus. If the draft standard is a consensus draft standard, then the OMB needs to evaluate the process for how the standard was developed and ensure that due process elements were met. OMB will reach consensus on the draft once all questions have been satisfactorily addressed. If approved, the standard is an approved AOAC standard. If the draft standard did not receive consensus by stakeholders, then OMB reviews the recommendations of stakeholders along with the audit. Staff will reconcile any gaps. This stage encompasses Detailed Step 7. STAGE 6: Publication of Standard and Outcomes: Outcomes of all deliberations along with status changes of standards are published in the AOAC Inside Laboratory Management (ILM). Any approved AOAC standards are published in the Official Methods of Analysis of AOAC INTERNATIONAL in both online and subsequent print editions. Press releases may be sent to announce the approval and/or publication of an approved AOAC standard. This stage encompasses Detailed Step 8.

WG Draft Standard (WGDS)

WG Draft Standard – Revision 1 (WGDS ‐ R1)

Title revision, terminology addition, and streamlined proposed policy statement – v3 (November 2019)

6

AOAC DUE PROCESS FOR DEVELOPMENT OF NON ‐ METHOD CONSENSUS STANDARDS AND DOCUMENTS Policy for Due Process in the Development of AOAC Standards and Consensus Documents

AOAC INTERNATIONAL (AOAC) develops and publishes voluntary consensus standards and documents in support of method development, method modification, and method use or implementation. AOAC establishes voluntary consensus standards and documents in accordance to national and international principles for ensuring due process. AOAC’s consensus and standards development activities include participation from diverse perspectives across a given analytical industry or community area, discipline or issue. Standards are developed upon consensus of stakeholders. Approval of standards is based upon confirmation that the standard has been developed in accordance with AOAC’s processes 1 and principles, and as outline in Figure 1. Examples of AOAC consensus documents and standards include voluntary consensus standards; performance standards; methods of analysis; guidance documents; concepts of operation; best practice recommendation documents, and sampling approaches. POLICY STATEMENT AOAC develops national and international analytical non ‐ method consensus and standards documents according to the national and international principles for ensuring due process in the development of consensus documents and standards: openness, transparency, lack of dominance, balance, due consideration, coordination, consensus, and appeals. The AOAC Official Methods Board oversees the implementation of scientific and technical policies and procedures established by the AOAC Board of Directors including those for ensuring due process in establishing standards and consensus documents as outlined in Figure 1. The rules of engagement and parliamentary procedures for AOAC standards developing bodies follow Robert’s Rules of Order (latest edition) in accordance with AOAC bylaws and policies.

Figure 1 ‐ Overview Flow for Consensus & Standard Development

1 AOAC has documentation on the details of the processes used to develop its standards and consensus documents. These supporting documentation include terminology, process details in text with an accompanying flowchart, and a document stage handout.

Approved by AOAC Board of Directors on June 10, 2020.