ERP_MicrobiologyMethods_Meeting_Book_11-2022

AOAC Analytical Methods Week November 30, 2022 ERP for Microbiology Methods for Food & Environmental Surfaces

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

Meeting Book

Table of Contents

PRELIMINARY ITEMS ERP Roster

3 4 5 8

Draft ERP Meeting Agenda

AOAC Policies, Procedures and Strategic Plan

Revised OMA, Appendix G

12

ERP Member and Meeting Criteria and Expectations

REVIEW OF PROPOSED OMA MODIFICATIONS AOAC 2021.02: Salmonella species in a Broad Range of Foods and Selected Environmental Surfaces Summary of Reviews

20

Proposed revisions to AOAC 2021.02

AOAC 2021.05 – Listeria monocytogenes in a Broad Range of Foods and Selected Environmental Surfaces Summary of Reviews

30

Proposed revisions to AOAC 2021.03

AOAC 2021.06 – Listeria species in a Broad Range of Foods and Selected Environmental Surfaces Summary of Reviews

47

Proposed revisions to AOAC 2021.06

AOAC 2019.03 – E. coli O157:H7 in Select Foods Summary of Reviews Proposed revisions to AOAC 2019.03 AOAC 2020.06 – Enterohemorrhagic E. coli in Select Foods. Summary of Reviews

63

69

Proposed revision to AOAC 2020.06

AOAC 2013.02 – Salmonella species in a Variety of Foods and Environmental Surfaces Summary of Reviews

76

Proposed revisions to AOAC 2013.02

PROPOSAL FOR A TECHNICAL BULLETIN Analytical Confirmation Memorandum

82

2023 Analytical Methods Weeks

84

ERP Meeting Book - November 2022

ERP ROSTER FOR THE AOAC ERP FOR MICROBIOLOGY METHODS FOR FOOD & ENVIRONMENTAL SURFACES (as of March 2022)

Daniele Sohier (CO-CHAIR) Thermo Fisher Scientific daniele.sohier@thermofisher.com Catharine Carlin (CO-CHAIR) Mérieux NutriSciences catharine.carlin@mxns.com

Lienau, Andrew MilliporeSigma andrew.lienau@milliporesigma.com McMahon, Wendy Mérieux NutriSciences Wendy.mcmahon@mxns.com Quiring, Christophe Bio-Rad Christophe_quiring@bio-rad.com Jonathan David Tuya Salas Instituto Nacional de Calidad (INACAL) jondavtusa@gmail.com Trueheart, Ashley Eagle Analytical atrueheart@eagleanalytical.com Tudor, Alexandra TEQ Analytical Labs atudor@teqanalyticallabs.com Williams, Jessica Thermo Fisher Scientific jessica.williams@thermofisher.com

Achen, Maya Abbott Nutrition Maya.achen@abbott.com

Carter, Mark MC Squared mark@mc2e.net

Chen, Yi US FDA, CFSAN Yi.Chen@fda.hhs.gov

Fatemi, Peyman Institute for Environmental Health Peymanf2@yahoo.com Fernandez, Maria Cristina University of Buenos Aires fernandezferraromc@gmail.com Flannery, Andrew Smiths Detection andrew.flannery@smiths-detection.com Hammack, Thomas US FDA, CFSAN thomas.hammack@fda.hhs.gov

Zhang, Lei Neogen Corporation lzhang@neogen.com

ERP Meeting Book - November 2022

AOAC ERP FOR MICROBIOLOGY METHODS FOR FOOD AND ENVIRONMENTAL SURFACES AOAC ANALYTICAL METHODS WEEK NOVEMBER 28 – DECEMBER 7, 2022

DRAFT ERP MEETING AGENDA Wednesday, November 30, 2022 10:30AM –1:00PM ET

Co-Chairs: Catharine Carlin (Mérieux NutriSciences) and Daniele Sohier (Thermo Fisher Scientific)

I.

WELCOME AND INTRODUCTIONS (Carlin/Sohier) Catharine Carlin and Daniele Sohier will welcome attendees and AOAC will establish the presence of an ERP quorum via roll call by Saliha Argubie (AOAC).

II.

ERP MEETING PROCEDURES OVERVIEW (McKenzie/Argubie) McKenzie will provide an overview of procedures for the ERP meeting and method review.

III. SUBMISSION OF OFFICIAL METHODS WITH MODIFICATIONS* (Carlin/Sohier/McKenzie) A. There is a group method modification submitted by Thermo Fisher Scientific for improvements to the SureTect workflow of the Thermo Scientific™ SureTect™ Real-Time PCR Assays that include updated plastic plate format with new carry trays for instrumentation; blue dye moved from one reagent to another at the same concentration; new handling tools to ease handling; option of a pierceable lysis seal for the following OMAs: • AOAC 2021.02 - Salmonella species in a Broad Range of Foods and Selected Environmental Surfaces • AOAC 2021.05 – Listeria monocytogenes in a Broad Range of Foods and Selected Environmental Surfaces • AOAC 2021.06 – Listeria species in a Broad Range of Foods and Selected Environmental Surfaces B. There are two method matrix extensions submitted by bioMérieux for two of the GENE UP® series of assays to include MicroTally cloth from pork and beef trim for the following OMAs: • AOAC 2019.03 – E. coli O157:H7 in Select Foods • AOAC 2020.06 – Enterohemorrhagic E. coli in Select Foods C. There is a major modification submitted by Hygiena for the BAX® System Real-Time PCR Assay for Salmonella – BAX® System SalQuant™ acts as an extension of the BAX System Real-Time assay for Salmonella where the CT values obtained from the Real-Time assay for Salmonella are exported into a linear-fit equation (provided by Hygiena) to estimate the Log10 CFU/g of Salmonella present. • AOAC 2013.02 – Salmonella species in a Variety of Foods and Environmental Surfaces IV. PROPOSAL FOR NEW TECHNICAL BULLETIN* A. The AOAC Research Institute has submitted a memorandum regarding the acceptance of microbiology methods whereby a second rapid method based on a different principle or different molecular target could be used to corroborate the presumptive results of the initial screening method, thereby increasing the likelihood that a presumptive screening positive is a true positive (e.g., a claim of being a confirmatory method from the enrichment, i.e., ‘analytical confirmation’ as opposed to ‘cultural confirmation”). See the memorandum for discussion points. FUTURE 2023 ERP MEETINGS* A. For 2023, the ERP can meet during the AOAC Midyear Meeting and during Analytical Methods Weeks (AMWs) in April, July, and November 2023. The ERP can select the dates for the AMW sessions. VI. ADJOURNMENT (Carlin/Sohier) V.

ERP Meeting Book - November 2022

ACCESS TO AOAC BYLAWS, POLICIES & PROCEDURES, AND STRATEGIC PLAN AOAC INTERNATIONAL Bylaws (201 9 ) 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.

ERP Meeting Book - November 2022

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

AOAC INTERNATIONAL Strategic Plan ERP Meeting Book - November 2022

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

ERP Meeting Book - November 2022

Appendix G: Procedures and Guidelines for the Use of AOAC Voluntary Consensus Standards to Evaluate Characteristics of a Method of Analysis

Action status. Scientists are recruited to serve as ERP members or as ERP Chair through a public call or by recommendation by members of AOAC, including the relevant communities. Interested scientists are invited to submit their curriculum vitae (CV) for initial assessment by the AOAC Science Team, who then forward to the OMB evaluations and recommendations for formal review. Both the Science Team and OMB strive to ensure that the composition of a proposed ERP is both qualified and equitably representative of stakeholder groups. The OMB approved ERP candidates are reviewed and appointed as ERP Members by the AOAC President. The Chair of an ERP serves as moderator for discussions, ensuring all relevant topics of a method are adequately discussed prior to a call for a vote. ERP Requirements (1) When established, an ERP must consist of a minimum of 7 Voting Members representing a balance of stakeholders. (2) A quorum is established by the presence of 7 Voting Members or 2/3 of total Voting Members, whichever is greater. (3) The ERP must hold transparent public meetings. Method Submission

Official Methods Board, Expert Review Panels,

First and Final Action Official Methods SM Since 2011, Expert Review Panels (ERPs) have been used to assess methods against Standard Method Performance Requirements (SMPR ® ). In 2021, after a decade of successful adoption of over one hundred Official Methods, the Official Methods Board (OMB) undertook a review to integrate and clarify the standards process, to ensure continued best practice, while recognizing and embracing flexibility to meet each community’s needs as part of the Official Methods Program. Definitions Call for Methods : public announcement inviting method submissions for a given analyte and/or matrix. Candidate Method: a method accepted into the Official Methods Program for possible adoption as First Action. Evaluation Period : interval between adoption as First Action and consideration as Final Action during which further method validation or information gathering is undertaken. First Action : AOAC First Action Official Methods . Final Action : AOAC Final Action Official Methods . Lead Reviewer : an ERP Voting Member charged with presenting in depth method reviews and making initial recommendations to the ERP. Non-voting Observer : a contributing expert to scientific deliberations of ERP, however, is ineligible to vote during an ERP meeting. Method Author : method developer or developer’s representative who serves as primary contact throughout Official Method development.

UNPUBLISHED DRAFT 11/2022 ERP ORIENTATION Stakeholder : A person or business with vested interest in a method approval. This typically includes method users, regulators, method developers, relevant consultants and special interest groups. Voting Member: scientific expert vetted by the OMB and selected to vote on motions as part of an ERP meeting. OMB Oversight Methods may be submitted by the Method Author at any time, although typically submission will occur during the Call for Methods period. All submitted methods must be accompanied by validation data upon which the ERP can undertake a comprehensive review. Various method performance parameters may be required or expected by different ERPs depending upon the nature of the analytes, matrices, and techniques pertinent to the method. Each community will assess the necessary forms that this validation may include, such as: • range of matrices tested • repeatability • reproducibility • other inter-laboratory precision • recovery

The OMB serves the Association in a scientific and advisory capacity. As such, the OMB is responsible for oversight of the Official Methods Program and ensures compliance to policies and procedures in the development voluntary consensus standards. See Figure 1 for process flowchart. ERP Formation An ERP is authorized to adopt candidate methods as First Action and to recommend subsequent adoption for Final

• comparison to reference material • comparison to reference method • ruggedness/robustness • specificity/selectivity • linearity and/or analytical range • limits of detection and/or quantitation • stability • inclusivity/exclusivity • uncertainty • probability of detection.

ERP Meeting Book - November 2022

Figure 1. Process for development of voluntary consensus standards for methods of analysis within the AOAC Official Methods Program

Member who abstains on grounds other than a declared conflict of interest should delineate reasons. Where the number of abstentions exceeds 1/3 of the Voting Members present, the vote is declared invalid and must be retaken at a later date. First Ballot (1) A motion shall pass the First Ballot only by unanimous affirmative vote of the ERP. (2) A motion shall fail if negative votes exceed 1/3 of the vote. (3) If neither (1) or (2) is achieved, reasons must be delineated for negative votes. Following further discussion, a second ballot is taken. Second Ballot

The minimum necessary parameters may be specified by the relevant community as part of SMPR development ( Official Methods of Analysis , Appendix F: Guidelines for Standard Method Performance Requirements). Acceptable experimental designs used to collect this data may vary with the method protocol and the intended use of the method. ERP Voting Votes must be cast by show of hands at in-person meetings and by roll call at virtual/remote meetings. Abstentions

UNPUBLISHED DRAFT 11/2022 ERP ORIENTATION At the beginning of an ERP meeting when the agenda is confirmed, Voting Members must declare any perceived or actual conflicts of interest to any agenda items on which a vote will be called. Such a declaration need not preclude a Voting Member from voting, and at that time, the ERP Chair will rule whether any Voting Member must abstain from voting on that particular agenda item based upon this declaration. All Voting Members and Non-voting Observers, whether they have a declared conflict or not, are freely able to share their expertise during the discussion period prior to the First Ballot. After further discussion and consideration, a motion passes the Second Ballot by 2/3 or greater affirmative vote. Review of Methods for First Action Methods submitted to AOAC are collected and compiled by the Science Team and are categorized as Candidate Methods and assigned a unique identifier.

An ERP meeting, open to all interested parties, is convened to review Candidate Method(s). Two (or more) ERP members may be assigned by the ERP Chair as Lead Reviewers to provide in depth, written reviews and to make a recommendation for First Action adoption, as appropriate. The merits and deficiencies of the Candidate Method are reviewed and discussed by the ERP, using the relevant SMPR (where applicable) as a guide. Down-selection If the stakeholders have designated in the SMPR the need for a dispute resolution method, the ERP may identify a single candidate method as dispute resolution method.

Voting Members may need to abstain on motions pertaining to: (i) methods they have authored or co authored; (ii) methods from entities with which they are affiliated; or (iii) methods from other entities in which a conflict of interest has been identified. Abstentions are not counted as a “yes” or “no” vote, but instead are a non-vote and contribute only toward establishing a quorum. Duty to Vote Unless required by the Chair to abstain, all Voting Members are expected to vote on all motions. Any Voting

ERP Meeting Book - November 2022

Any additional validation data obtained during this period is to be collated by the Method Author and submitted to the ERP for review. Additionally, responses to requirements or recommendations made by the ERP at the time of First Action adoption should be submitted to the ERP for consideration. For quantitative methods, data demonstrating reproducibility and uncertainty must be present for Final Action consideration. Experimental designs to collect this data may vary with the method protocol, available laboratories, and the intended use of the method (i.e., collaborative studies, proficiency testing, etc.). The ERP may consider other forms of information, such as proficiency data, in lieu of the traditional collaborative study to demonstrate method reproducibility. For qualitative methods, data demonstrating the probability of detection at specified concentration levels as applicable must be present for Final Action consideration. Experimental designs to collect this data may vary with the method protocol, available laboratories, and the intended use of the method. Review of Methods for Final Action At the conclusion of the Evaluation Period, an ERP meeting is convened. Lead Reviewers will report to the ERP on assigned First Action methods and should assess any additional validation data or information provided during the Evaluation Period and make a recommendation for deferral, repeal of First Action status, or adoption as Final Action. Deferral If, at the end of the Evaluation Period, the feedback from method users or additional validation data supplied is deemed inadequate or inconclusive, the ERP may choose to retain First Action status to allow time for further information or validation data to be acquired. The ERP should discuss strategies to obtain additional information to make an appropriate Final Action decision. Subsequent deferrals of a First Action Method by the ERP must be justified to OMB for continued retention of First Action

Requirements/Recommendations for Final Action After First Action adoption, the ERP may choose to make specific requirements or recommendations to the Method Author. This information should be clearly delineated and approved by the ERP as official recommendations and/or requirements, to be revisited upon consideration for Final Action. Candidate Method Resubmission When a Candidate Method is not adopted as First Action, the ERP shall document its concerns with the methodology and/or associated validation data, the reasons for this decision, and any expected remedies necessary as part of resubmission of the method. This information must be clearly delineated and approved by the ERP as official recommendations and/or requirements. Upon subsequent review(s), the ERP should focus on whether the Method Author has complied with the documented concerns from the initial ERP review. However, the ERP reserves the right to raise any issue at any time that may materially impact upon method fitness for-purpose and/or ability to meet the requirements as defined in the applicable SMPR(s), regardless of whether Candidate Methods are not required to be submitted for ERP review in AOAC Official Methods format. However, subsequent to First Action adoption, AOAC Staff will support the Method Author in ensuring proper formatting of the method for publication in Official Methods of Analysis . (1) A Candidate Method becomes First Action on the date when the ERP motion is passed. (2) Methods must be drafted into AOAC format by the Method Author. (3) The Official Method status decision is reported concurrently with the method in traditional AOAC publication venues. this was raised in a previous review. Publication of First Action Methods

UNPUBLISHED DRAFT 11/2022 ERP ORIENTATION As part of First Action publication in the Official Methods of Analysis , the method authors must have an accepted manuscript or published paper in a reputable scientific journal, preferably the Journal of AOAC INTERNATIONAL , containing relevant validation data. Evaluation Period status. Repeal At the end of the Evaluation Period, if the feedback from method users indicates that the performance of a First Action method in other laboratories is unacceptable; or if no further validation data is obtained, the ERP may vote to repeal the First Action status of a method. Final Action

A First Action method undergoes additional evaluation and validation studies to be considered for Final Action status. The ERP will meet to consider the status of a First Action method following an evaluation period of two years, or earlier at the Method Authors’ request. Users of First Action methods are asked to provide feedback to AOAC or the Method Author on the performance of the method during the Evaluation Period, to include positive and negative feedback, as well as specific feedback about ruggedness. This feedback, as well as an assessment of future availability of vital equipment, reference materials, and supplies must be documented in a report by the Method Author for consideration by the ERP.

A recommendation for a method as Final Action is forwarded to the OMB and the method process undergoes a full procedural review and OMB approval. OMB Review The OMB will review all recommendations for Final Action adoption, deferral, or repeal by the ERP using applicable factors in their decision:

ERP Meeting Book - November 2022

same manner as the method under its original scope. Each ERP should develop method extension guidelines to suit its needs. Method Modifications Modification to an Official Method may be editorial, minor, or major. Upon submission of a method modification application, AOAC staff identify editorial modifications and process changes through AOAC publications. The classification of minor and major modifications is made by the ERP following a public comment period. Minor changes should not be expected to affect the current validated performance nor significantly affect measured results. Supporting information to justify the proposed modification must accompany a request for ERP review of a minor modification to an Official Method and equivalency data may be required to justify a method change. Major modifications to a method will likely impact measured results or change method performance. This level of modification will result in the creation of a new method, with a new method number, and will follow the Official Methods Program guidance for voluntary consensus standards in same manner as any other new method. Conclusion This universal pathway to Official Methods has been designed to simplify and harmonize the method review process within AOAC. The intent of this universal pathway is to provide a single framework for experts in analytical sciences to apply their scientific knowledge, experience, and judgment in an evidenced-based manner to identify, review, and adopt the best methods currently available to meet the analytical needs of each community within AOAC INTERNATIONAL.

Procedural • ERP recommendations and improvements completed • Draft Final Action method reviewed by ERP • Reference materials used • Verify Community validation protocols followed • Verify SMPR criteria met • Feedback from users of method considered • Statistics Committee review • Safety and Security Committee review Documentation • Validation data • Statistics Committee report • Safety and Security Committee report • User feedback • External status • ERP Report • Impact statement from author • Method in OMA format • Manuscript(s) published or in press The OMB may ask ERPs for further information on any potential points of concern. Publication of Final Action Methods As part of Final Action adoption, method authors must have an accepted manuscript or published paper in a reputable scientific journal, preferably the Journal of AOAC INTERNATIONAL , containing relevant validation data. Extensions of Scope For methods which have attained Official Method status for an analyte or analytes in one or more matrices, an extension of scope may be sought such that the method would be considered as an Official Method for additional matrices or additional analytes. The validation required for an extension of method scope would typically be, as a minimum, the same as that required by the ERP for a method to obtain First Action status. However, the ERP may recommend alternative validation data to demonstrate that the extended method performs in the

UNPUBLISHED DRAFT 11/2022 ERP ORIENTATION This guidance document was approved by the AOAC Board of Directors on MMM DD, YYYY

ERP Meeting Book - November 2022

OFFICIAL METHODS OF ANALYSIS OF AOAC INTERNATIONAL FIRST ACTION TO FINAL ACTION GUIDANCE FOR METHOD AUTHORS

M

ethods published in the Official Methods of Analysis of AOAC INTERNATIONAL (OMA) undergo scientific validation and evaluation. Methods in good standing are designated as First Action status upon initial adoption by an AOAC expert review panel (ERP). Methods are designated as Final Action status upon

consensus of the AOAC Official Methods Board.

AOAC First Action status methods are tracked for a maximum of two (2) years and then evaluated for a status change. ERPs track the methods during the two year period during which the method is expected to be used and during which time, method reproducibility can be assess (if not completed), method performance feedback from method users, laboratory proficiency testing results, method modifications, etc… ERPs may make suggestions following the initial adoption of a method to be completed during the two ‐ year tracking period. At the end of the two ‐ year period, the ERP reviews the method and all information gathered during the two ‐ year period to verify that a final version of the method is substantiated. The guidance below is for authors of the published manuscripts of the methods published in the OMA that are under consideration for status changes.

Method authors will need to consider the following: 1. Review the method as it is published in the OMA a. If there are changes, request an MS Word tracking version of the method from AOAC by contacting Deborah McKenzie at dmckenzie@aoac.org. 2. Review the ERP report from when the method underwent its last review. a. Are there any ERP requirements that were agreed upon for the method? These may include additional data submission, etc…. 3. Collect performance feedback on the method. a. Can come from collaborators and/or other method users, PT data may also be included. 4. Has method reproducibility been assessed and reviewed by the ERP? a. If this was completed as part of the initial adoption of the method. b. If this has been recently collected, then you need to do the following: i. Draft a manuscript in AOAC format. ii. It is highly recommended that the manuscript and raw data

files will require a review by AOAC Committee on Statistics

METHOD AUTHOR SUBMISSION PACKAGES 1. Submission package for Final Action status consideration must include the following individual files: a. AOAC formatted manuscript with reproducibility b. Separate files for tables and figures c. Copy of the published method with tracked changes for the final version of the method d. Presentation to the ERP 2. Submission package for Continuance of First Action status must include the following: a. Written rationale for continuance with a timeframe b. Any supporting information such as proposal for additional or continuing studies. 3. Submission package for Repealing a method from the OMA a. Written rationale for removing the method b. Any supporting information

Version: 11 ‐ 2020

ERP Meeting Book - November 2022

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 Book - November 2022

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

ERP Meeting Book - November 2022

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

ERP Meeting Book - November 2022

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.

ERP Meeting Book - November 2022

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

ERP Meeting Book - November 2022

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.