AOAC OFFICIAL METHODS PROGRAM - APPLICATION E-BOOK

AOAC INTERNATIONAL OUR MISSION:

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

OFFICIAL METHODS OF ANALYSIS SM (OMA) PROGRAM The Official Methods of Analysis SM (OMA) program is AOAC INTERNATIONAL's premier methods program. The program evaluates chemistry, microbiology, and molecular biology methods. It also evaluates traditional benchtop methods, instrumental methods, and proprietary, commercial, and/or alternative methods. In 2011, AOAC augmented the Official Methods SM program by including an approach to First Action Official Methods SM status that relies on gathering the experts to develop voluntary consensus standards, followed by collective expert judgment of methods using the adopted standards. All methods in the AOAC Official Methods SM program are now reviewed by Expert Review Panels for First Action AOAC Official Methods of Analysis SM status, continuance, repeal, and/or to recommend for AOAC Final Action Official Methods status. The OMA program has undergone a series of transitions in support of AOAC's collaborations, evolving technology, and evolving technical requirements. Methods approved in this program have undergone rigorous scientific and systematic scrutiny such that analytical results by methods in the Official Methods of Analysis of AOAC INTERNATIONAL are deemed to be highly credible and defensible. The methods are published in the Official Methods of Analysis of AOAC INTERNATIONAL and supporting manuscripts are published in the Journal of AOAC INTERNATIONAL . AOAC Official Methods SM program allows for submissions for all proprietary, single and sole source methods. Methods submitted through the PTM-OMA harmonized process also will be reviewed through the O fficial Methods of Analysis SM (OMA) program. Other complementary products and services include expanded consulting services for validation protocol development and AOAC INTERNATIONAL Organizational Affiliate Membership.

AOAC INTERNATIONAL 2275 Research Blvd, Suite 300 Rockville, Maryland 20850 Phone: (301) 924-7077

OMA PROGRAM & SERVICES – APPLICATION OVERVIEW

ONLINE APPLICATION

LINK

CONSULTING SERVICES ONLINE APPLICATION OFFICAL METHODS PROGRAM ONLINE APPLICATION

SECTION 1A: APPLICANT CONTACT INFORMATION Please note that this application must be completed and submitted by the contact that is authorized by the organization to pursue and obtain validations and/or development of protocols. All correspondence in relation to this application will be directed to the contact listed in this section.  First & Last Name  Organization  Email *  Phone Number *  Address SECTION 1B: FINANCIAL CONTACT INFORMATION Please provide the contact information for the person within your organization that will be responsible for receiving and processing the payments for invoicing.  First and Last Name  Email  Phone Number SECTION 2: TERMS & CONDITIONS Please read all the Terms and Conditions, AOAC International Policy Documents (Use of Association Name, Anti-Trust, Volunteer Conflict of Interest, and the associated Fee Schedule.  By completing and submitting this application, you are agreeing to the Terms and Conditions stated above: SECTION 3: SUBMISSION & METHOD INFORMATION The following information below will assist with detailing the method information that will be required for your submission for Consulting Services and the AOAC Official Methods of Analysis SM Program. CONSULTING SERVICES APPLICATION SECTION 3A: SUBMISSION INFORMATION  For which method assessment program is/are testing protocols to be developed.

 AOAC Official Methods Program- Sole Source Methods  AOAC Official Methods Program- Proprietary Methods  AOAC Official Methods Program - Standards Development (AOAC SMPR) • SMPR No.

 Please indicate the method type:  New Method  Method Modification  Please indicate the type of protocol(s) requested:  Single Laboratory Validation  Multi-Laboratory /Collaborative Validation  Analysis Type

 Qualitative  Quantitative  Reference Methods, if applicable. SECTION 3B: METHOD INFORMATION  Legal Name of Method  Analyte(s)

 Matrice(s)  Method Applicability and Intended Use

SECTION 3C: METHOD DOCUMENTATION & UPLOADS Please upload all required documentation. Multiple files may be uploaded in each section noted below. File sizes must be less than 100MB each. Scanned copies must be clearly legible.  Method User Guides/Package Inserts/Method Steps  Supplemental Documents

www.aoac.org

OMA PROGRAM & SERVICES – APPLICATION OVERVIEW

OMA PROGRAM APPLICATION SECTION 3A: SUBMISSION INFORMATION  Please select the method assessment program for which this method will be reviewed:  AOAC Official Methods Program- New Method  AOAC Official Methods Program- Method Modification  Please indicate the type of proposed modification:

  Please indicate the method submission type:  Sole Source Method/Non-Proprietary  Proprietary Method  Call for Methods (Not currently available)  Please indicate the type of protocol(s) requested:  Single Laboratory Validation  Multi-Laboratory /Collaborative Validation  Analysis Type  Qualitative  Quantitative SECTION 3B: METHOD INFORMATION  Legal Name of Method  Analyte(s)

 Matrice(s)  Method Applicability and Intended Use

 For Modifications:

 Summarize the Proposed Modification  Describe how the modification will be evaluated SECTION 3C: METHOD DOCUMENTATION & UPLOADS Please upload all required documentation. Multiple files may be uploaded in each section noted below. File sizes must be less than 100MB each. Scanned copies must be clearly legible.  Method Manuscript/Method  Protocol(s)  Method User Guides/Package Inserts/Method Steps  Supplemental Documents

www.aoac.org

OMA PROGRAM – PROCESS DESCRIPTION

Expert Review Panel Process • ProjectOnboardingTeleconference • ProgramOrientationWebinar

Expert Review Panel Meeting & Method Review • Consensusto obtainoneof the following: • AOAC First ActionOfficial MethodsStatus • AOAC Final Action Official Methods Recommendation • Repealor Continance

Complete Online Application • New & ModifiedMethods • Single,Sole Source,& ProprietaryMethods Accepted • Upload Method Information • SubmitRemittance forApplicationFee

Method Performance Feedback

METHOD SUBMISSION TYPES

SUBMISSION OF METHODS IN RESPONSE TO A CALL FOR METHODS BASED ON STANDARDS (SMPR's): AOAC INTERNATIONAL invites method authors and developers to submit relevant methods that may meet the AOAC Standard Method Performance Requirements (SMPR®). For methods submitted through an open Call for Methods, please see the Standards Development submission deadlines. For a specific open Call for Methods or more detailed information, please refer to the AOAC homepage under the “Call for Methods” tab. This application does not need to be submitted for methods submitted for the Call for Methods, please refer to the information noted on the website. SUBMISSIONS OF PROPRIETARY & SOLE SOURCE METHODS: Please note the upcoming method submission deadlines for the AOAC Official Methods of AnalysisSM (OMA) Program including candidate Proprietary, Single and Sole Source Methods. *Proprietary methods may be reviewed up to four (4) times per year. This application applies to only proprietary and sole source methods. Please note that fees apply for these method submissions. • AOAC Consulting Services is also available for those who need assistance with protocol development, manuscript writing, etc. for further information, please click here . • For additional information on AOAC Guidelines and References, please click here . SUBMIT YOUR METHOD & COMPLETE ONLINE APPLICATION Step 1: Application Process The method author and/or champion of the method must complete the application and submit all required documentation. Please refer to the Application Overview for further details. REQUIRED APPLICATION DOCUMENTATION: 1) Method manuscript in OMA format 2) Package insert or user manual, (if rapid method or test kit) 3) Safety checklist 4) Validation protocols ( not required if AOAC Consulting Service is used ) APPLICATION FEES The application fees, discounts, billing information and payment terms for the AOAC Official Methods of Analysis SM (OMA) Program can be found on page [??] of this e-book. The AOAC Expert Review Panels (ERPs) are a key part of AOAC INTERNATIONAL’s Method Approval Process. AOAC ERPs are authorized to adopt candidate methods as First Action Official Methods and to recommend adoption of these methods to Final Action Official Methods status. Scientists are recruited to serve on ERPs in a variety of ways. Normally, a call for experts is published at the same time as a call for methods is posted. Interested scientists are invited to submit their curriculum vitae (CV) for consideration. Advisory panel, stakeholder panel, and working group members may make recommendations to AOAC for ERP members. All CVs are reviewed and evaluated for expertise by the AOAC Chief Scientific Officer (CSO) and then to the AOAC Official Methods Board for formal review. The composition of the ERP must be fulfilled with qualified subject matter experts representing various perspectives. Please refer to our Call for Experts on the AOAC homepage for further information. AOAC EXPERT REVIEW PANEL PROCESS Step 2: Expert Review Panel (ERP) Process

www.aoac.org

OMA PROGRAM – PROCESS DESCRIPTION

AOAC CALL FOR EXPERTS AOAC will obtain expert reviewers via our Call for Experts to review the submitted method. Proposed ERP candidates with demonstrated expertise are reviewed and vetted by the AOAC Official Methods Board. The ERP will be responsible for the following:

• Review methods for First Action Official Methods SM status • Adopt methods as First Action Official Methods SM status • Track First Action methods for 2 years after adoption •

Review any additional information (modifications, protocols, collaborative studies, proficiency testing, and other feedback) and make recommendations to the AOAC Official Methods Board regarding Final Action status. All vetted Expert Review Panel Members have agreed to the AOAC INTERNATIONAL Antitrust Policy, AOAC INTERNATIONAL Policy on The Use of The Association, Name, Initials, Identifying Insignia, Letterhead, And Business Cards, AOAC INTERNATIONAL Policy and Procedures on Volunteer Conflict of Interest, and have signed the AOAC Volunteer Acceptance Form. AOAC EXPERT REVIEW PANEL ORIENTATION This presentation from our webinar will provide new volunteers the opportunity to learn about the logistics of participation on an AOAC expert review panel (ERP) while seasoned volunteers will have an opportunity to receive a refresher course on expectations of ERP chairpersons and ERP members. AOAC Expert Review Panels (ERPs) have specific roles and responsibilities. We will discuss in detail the rules for demonstrating ERP consensus regarding voting members, non-voting members, and abstentions. In addition, the Official Methods Board (OMB) will discuss the expectation of methods under consideration for Final Action status and what feedback they consider important for methods to have for First Action Official Methods being recommended for Final Action or repealed from the Official Methods of Analysis of AOAC INTERNATIONAL . The following discussion topics will aid volunteers on how to prepare, conduct and participate in AOAC ERP meetings.

• • • • • • • •

AOAC Method Submissions Process

Recruitment and Selection of ERP Members

Voting Rules and Quorum Policy

Method Review Process

Demonstrating ERP Consensus

First Action Official Methods Requirements First Action to Final Action Requirements

Method Feedback

AOAC EXPERT REVIEW PANEL MEETING AND METHOD REVIEW Step 3: Expert Review Panel (ERP) Meeting

The Expert Review Panel (ERP) will meet in person a minimum of two (2) to four (4) times per year: *AOAC Mid‐Year meeting (DC metro area) * AOAC Annual Meeting * Two (2) additional designated times for proprietary method Organizational Affiliates. Please refer to our OMA Method Submission Deadlines . 1. The AOAC Research Institute will advise the Applicant/Study Director(s) and ERP members of the upcoming meeting date, location, and time. We require that the Applicant/Study Director(s) of the method be present during the ERP meeting. During this time, the ERP may require changes and/or revisions to the manuscript to be updated in real-time. 2. The AOAC Research Institute will facilitate and coordinate the review process of the manuscript. The ERP will evaluate the method against the proposed collaborative study protocol and submit their recommendations. 3. At the conclusion of the review of the method, the ERP will render a decision to either grant or not to grant the method with an AOAC First Action Official Methods SM status.

www.aoac.org

OMA PROGRAM – PROCESS DESCRIPTION

AOAC FIRST ACTION OFFICIAL METHODS STATUS Step 4: First Action AOAC Official Methods SM Status •

If your method is granted AOAC First Action Official Methods SM status, it will be published in the Official Methods of Analysis of AOAC INTERNATIONAL and manuscripts are published in the Journal of AOAC INTERNATIONAL . • Method status changes are published in the AOAC Inside Laboratory Management magazine. • All method authors will be advised of any AOAC Final Action Official Methods SM status consideration requirements recommended by the specific AOAC Expert Review Panel. METHOD PERFORMANCE FEEDBACK PERIOD AOAC is soliciting method user feedback on the performance of AOAC First Action methods in the Official Methods of Analysis of AOAC INTERNATIONAL adopted in 2017 that have already or are approaching the completion of the two (2) year period following their adoption. Therefore, they are eligible to be considered for AOAC Final Action status in the Official Methods of AOAC INTERNATIONAL . Below is a list of AOAC First Action methods from the Official Methods of Analysis of AOAC INTERNATIONAL for methods adopted without the use of AOAC Standard Method Performance Requirements SM . A complete full listing of all methods are published in the AOAC Inside Laboratory Management (ILM) magazine. It is AOAC INTERNATIONAL’s policy that Expert Review Panels make recommendations no later than two (2) years following the adoption of a First Action Method. Method feedback will be shared with the Expert Review Panels (ERPs) who will consider this information as they develop their recommendations for the methods. These recommendations will go to the AOAC Official Methods Board (OMB) for consideration. The AOAC OMB will then review the recommendation and render a decision on the method status for a recommendation for Final Action status, Continuance, or Repeal. For additional information regarding submitting feedback, please see t he page [??\ of this e-book or visit AOAC INTERNATIONAL Method Performance Feedback Instructions .

AOAC FINAL ACTION OFFICIAL METHODS STATUS Step 5: Final Action Review

For Final Action Official Methods SM status consideration method performance feedback on method applicability, safety concerns, reference materials, single-laboratory validation, and reproducibility/uncertainty and probability of detection is required. ERPs track First Action AOAC Official Methods SM for a maximum of two (2) years. 1) The ERP evaluates the method performance feedback and can make the following recommendations to the AOAC Official Methods Board (OMB):

1. A recommendation for Final Action Official Methods SM status 2. A recommendation to repeal First Action or Final Action Official Methods SM 3. A recommendation to request a continuance of First Action Official Methods SM

4. The AOAC Official Methods Board reviews ERP recommendations and renders decisions on Final Action Official Methods SM status, repeal First Action or Final Action Official Methods SM , or grant a continuance of First Action Official Methods SM .

www.aoac.org

AOAC OFFICIAL METHODS SM PROGRAM SUBMISSION DEADLINES

2019 METHOD SUBMISSIONDEADLINES The Official Methods of Analysis SM (OMA) program is AOAC INTERNATIONAL's premier methods program. All candidate methods submitted to the AOAC Official Methods of Analysis SM program are reviewed by Expert Review Panels for First Action Official Methods SM status. The adopted First Action methods are reviewed and recommended for Final Action, repeal and/or continuance of an AOAC Official Methods SM status. SUBMISSION OF METHODS IN RESPONSE TO A CALL FOR METHODS BASED ON STANDARDS (SMPR's) : AOAC INTERNATIONAL invites method authors and developers to submit relevant methods that may meet the AOAC Standard Method Performance Requirements (SMPR®). For methods submitted through an open Call for Methods, please see below for the Standards Development submission deadlines. For a specific open Call for Methods or more detailed information, please refer to the AOAC homepage under the “ Call for Methods ” tab. SUBMISSIONS OF PROPRIETARY & SOLE SOURCE METHODS: (Methods without an associated SMPR®): Please note the upcoming method submission deadlines for the AOAC Official Methods of Analysis SM (OMA) Program including candidate Proprietary, Single and Sole Source Methods. *Proprietary methods may be reviewed up to four (4) times per year. Application fees may apply for these method submissions. For all inquiries regarding new, modified or potential method applications, please contact La’Kia Phillips at lphillips@aoac.org.

MEETING DATES

MEETING LOCATION

DEADLINE DATES FOR METHOD SUBMISSION

PROPRIETARY & SOLE SOURCE METHODS

STANDARDS DEVELOPMENT

2019 AOAC MID-YEAR MEETING GAITHERSBURG, MD 20850 USA EXPERT REVIEW PANELS [OMA METHODS WEEK-VIRTUAL] ROCKVILLE, MD 20850 USA 2019 AOAC ANNUAL MEETING & EXPOSITION DENVER, CO 80202 USA EXPERT REVIEW PANELS [OMA METHODS WEEK-VIRTUAL] ROCKVILLE, MD 20850 USA 2020 AOAC MID-YEAR MEETING GAITHERSBURG, MD 20850 USA

FRIDAY, JANUARY 18, 2019

FRIDAY, JANUARY 25, 2019

MARCH 11-14, 2019

FRIDAY, MAY 17, 2019

FRIDAY, MAY 31, 2019

JULY 8-12, 2019

SEPTEMBER 6-12, 2019

FRIDAY, JULY 12, 2019

FRIDAY, AUGUST 2, 2019

FRIDAY, OCTOBER 11, 2019

TBD

DECEMBER 2019

FRIDAY, JANUARY 10, 2020

FRIDAY, JANUARY 24, 2020

MARCH 2020

For more information on the AOAC Official Methods SM program, AOAC Analytical Consulting Service (expanded Consulting Service), or tutorials on the AOAC Official Methods SM program, please contact Deborah McKenzie at dmckenzie@aoac.org.

www.aoac.org

OMA PROGRAM – GUIDELINES & REFERENCES

Please note that the following references are website links listed for your use and reference during the protocol development and manuscript/method review process. These appendices, guidelines, and references can be accessed via the AOAC website.

These are website links, please press “CTRL” and select the document.

AOAC INTERNATIONAL POLICY DOCUMENTS A. AOAC By-Laws B. Volunteer Conflict of Interest C. Anti-Trust Policy

D. Policy on the use of the Association Name, Initials, Identifying Insignia, Letterhead, and Business Cards A. Appendix J: AOAC International Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces B. Appendix A: Standard Solutions and Reference Materials C. Appendix B: Laboratory Safety D. Appendix C: Reference Tables E. Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis F. Appendix F: Guidelines for Standard Method Performance Requirements G. Appendix G: Procedures and Guidelines for the Use of AOAC Voluntary Consensus Standards to Evaluate Characteristics of a Method of Analysis H. Appendix H: Probability of Detection (POD) as a Statistical Model for The Validation of Qualitative Methods I. Appendix I: AOAC International Methods Committee Guidelines for Validation of Biological Threat Agent Methods and/or Procedures J. Appendix K: Guidelines for Dietary Supplements and Botanicals K. Appendix L: AOAC Recommended Guidelines for Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Single-Laboratory Validation L. Appendix M: Validation Procedures for Quantitative Food Allergen Elisa Methods: Community Guidance and Best Practices M. Appendix N: ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods A. Standard Method Performance Requirements (SMPR) Guidelines (Appendix F) B. Official Methods Board Expert Review Panels (ERP) Guidelines (Appendix G) C. How to Write in AOAC (OMA) Style D. Guide to Method Format E. Formatting AOAC Protocols & Manuscripts F. Method Safety & Risk Assessment G. Journal Author Instructions

MICROBIOLOGY METHODS

CHEMISTRY METHODS /OTHER

GUIDELINES

SINGLE-LAB GUIDELINES & REFERENCES

A. Dietary Supplements SLV Guidelines (Appendix K) B. Food Microbiology Guidelines (Appendix J) C. Stakeholder Panel on Infant Formula & Adult Nutritionals (SPIFAN) SLV Guidelines (Appendix L)

www.aoac.org

OMA PROGRAM – GUIDELINES & REFERENCES

MULTI-LAB GUIDELINES & REFERENCES

A. Food Microbiology Guidelines (Appendix J) B. Collaborative Study Validation Guidelines (Appendix D) C. Biological Threat Agent Methods (BTAM) (Appendix I) D. Characterization of Antibodies Used in Immunochemical Methods of Analysis for Mycotoxins and Phycotoxins A. AOAC Interlaboratory Study Workbook - Blind (Unpaired) Replicates (Excel file .xls) B. AOAC Interlaboratory Study Workbook - Binary Data (Excel file .xls) C. LCF MPN Calculator - Ver. 1.6 (Zip file .zip)

STATISTICAL/MATHEMATICAL TOOLS

TECHNICAL BULLETINS The documents posted in this tab are not a replacement of validation guidelines or any standard method performance requirements. These documents are not AOAC policy or procedure. These documents summarize the decisions of the AOAC Expert Review Panel(s) (ERPs) formerly administered by the AOAC Research Institute related to method approval that provide clarification and that may be applicable to the development of validation study designs. A. Various clarifications and recommendations of the AOAC ERP for Microbiology Methods for Foods and Environmental Surfaces (May 15, 2016) B. Acceptable Multi-matrix Validation Claims for Food Microbiology Methods (May 15, 2016)

OTHER REFERENCE DOCUMENTS

A. First Action Official Methods SM of Analysis _Flowchart B. First Action Official Methods SM of Analysis Requirements

C. AOAC First Action Methods Orientation D. AOAC Final Action Methods Orientation

www.aoac.org

Format for AOAC Official Methods of Analysis

Online Technical Resources

Method Development, Optimization & Validation  OMA - Appendix F - Guidelines for Standard Method Performance Requirements  Homogeneity  Guide for Writing Methods in AOAC Format  Statistics Protocol Review Form  OMA - Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis  OMA - Appendix G: Procedures and Guidelines for the Use of AOAC Voluntary Consensus Standards to Evaluate Characteristics of a Method of Analysis  OMA - Appendix I: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Biological Threat Agent  Methods and/or Procedures  OMA - Appendix J: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces  OMA - Appendix K: Guidelines for Dietary Supplements and Botanicals  OMA - Appendix L: AOAC Recommended Guidelines for Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Single-Laboratory Validation  OMA - Appendix M - Validation Procedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices  Safety Checklist Method Review  Examples of Statistical Analysis  Statistics Manuscript Review Form  OMA - Appendix A: Standard Solutions and Reference Materials  OMA - Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis  OMA - Appendix H: Probability of Detection (POD) as a Statistical Model for the Validation of Qualitative Methods Miscellaneous  Definition of Terms and Explanatory Notes  OMA - Appendix B: Laboratory Safety  OMA - Appendix E: Laboratory Quality Assurance  OMA - Appendix C: Reference Tables

The language of the method should be concise and completely free from ambiguity. Conciseness is desirable, both to ensure clarity and to save space. Whenever there is a conflict between clarity and style, clarity is more important . Present Tense and Imperative Mode Check sentences that do not begin with a verb and change them, if feasible, to the imperative mode (e.g. Pipet 10 mL..., Stir..., etc.). Exceptions are: use of adverb modifier ("Accurately weigh..."), prepositional clause ("For refined sugars, use..."), permissive statements ("Ferric hydroxide may be used..."), and statements in the "Principle" section. Abbreviations Most abbreviations are the same as those used by Chemical Abstracts. Do not use abbreviations in titles and headings. See the Definitions of Terms and Explanatory Notes . Repetition and Redundancy Eliminate repetition and redundancy as far as possible; use only for emphasis. Do not use "distilled" with water, "concentrated" with common acids, "95%" with alcohol, or "ACS" with reagents covered by ACS specifications. These are understood by definition. Terminology, Formulae and Chemical Names For names of chemical compounds, use the spelling, hyphenation, and word division given in Chemical Abstracts. Use a national pharmacopeia for names for drugs. Use ISO nomenclature for pesticides and Codex nomenclature for names of food additives and color additives. Consistency Watch for internal contradictions in the text: volumes that do not add up or that exceed the capacity of the container; too abrupt a transition from one operation to another (a line may be omitted); and impractical or impossible numbers (e.g., 100 g NaCl will not dissolve in 100 mL water). Cross-references All new AOAC methods should be written as complete and self-contained as practical. Do not refer to other AOAC methods. If part of a procedure in an Official Method SM is taken from material previously published elsewhere, incorporate those steps in the method rather than referring the analyst to another publication. Definitions The section "Definition of Terms and Explanatory Notes," Official Methods of Analysis of AOAC INTERNATIONAL , is the basic guide to conventions and consistency. Illustrations and Tables If symbols are used on the figure, include an explanation in the caption or text. Provide descriptive titles for tables. Explain any obscure headings in a footnote. Bibliographic References Check all references for accuracy. Use standard Chemical Abstracts abbreviations for Journal titles. In general avoid references in method. Cite background references in the "Introduction" or "Discussion" section of the collaborative study manuscript -- not in the method. If part of a procedure in an Official Method SM is taken from material previously published elsewhere, incorporate those steps in the method rather than referring the analyst to another publication. Safety All methods must be reviewed for safety and potential hazards. Methods should automatically incorporate cross-references to the safety statement(s), or present questioned conditions to the attention of the Committee on Safety for resolution. Decisions regarding inclusion of safety statements should be practical, recognizing that overuse will be self-defeating. Methods that create toxic, obnoxious or environmentally hazardous fumes and wastes should contain practical directions for disposal. Checking Edited Copy and Proofreading The author must review a copy of the original version and edited copy to ensure that there has been no change in meaning, to correct typographical errors, and to answer any questions posed by the editor. The author must review the typeset method for accuracy.

All resources are accessible at http://www.aoac.org/vmeth/guidelines.htm

For questions, please contact:

P 301-924-7077 x157

E dmckenzie@aoac.org

Revised October 2013 © 2013 Copyright AOAC INTERNATIONAL

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FORMAT OF AOAC® OFFICIAL METHODS of ANALYSIS OF AOAC INTERNATIONAL

Title: 

Includes analyte being determined, type of matrix (matrices), and analytical technique used for analysis.

Applicability: 

Includes list of matrix(es) along with specific matrix types and range or limits of determination or detection.

Precautions: 

Makes an analyst aware of hazardous materials used in analysis.

Data Collection: 

Table(s) that presents performance parameters including matrices tested in a collaborative study, levels of analyte(s), % recovery, RSD r , RSD R , s r , s R , HORRAT, number of observations, etc

Principle: 

Explains scientific premise on which the method is operates specifically the mechanism of the analysis.

Apparatus: 

Lists the equipment that requires assembly or that has specifications critical to the method performance. Describe equipment in terms of performance characteristics.

Reagents: 

List the reagents with amounts and appropriate units needed to conduct the analysis and describe the reagents in terms of performance characteristics.

Sample and Test Portion Preparation: 

Describe the preparation of samples and the test portion.

Determination: 

Describes the actual analysis.

Calculations: 

Section that explains how to calculate final results; presented in a form of equation or description.

The AOAC style used for preparing methods for publication in the Official Methods of Analysis of AOAC INTERNATIONAL includes the following essentials:

Other sections as needed

 Standardized format that follows the order of laboratory operations.  Use of the imperative mode.  Cross-references to identical reagents, apparatus, and operations.  Use of standardized definitions, terminology, and style.  Use of accepted abbreviations and simplifications.  Use of SI units  Methods should be written as complete and self-contained as practical.  Normality should be referred in terms of Molarity.  ppm should be changed to mg/kg or mg/L  ppb should be changed to ng/g or ng/mL  ppt should be changed to pg/g or pg/mL

REFERENCING AOAC ® OFFICIAL METHODS SM

When referencing AOAC® Official Methods SM , only the method number should be used as seen in the following example: (1) Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA, Official Method 2008.01

Revised October 2013 © 2013 Copyright AOAC INTERNATIONAL