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AOAC INTERNATIONAL

A 2014 OverviewAs of April 2014

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This presentation is designed to give Sections an overview of current activities and services at AOAC INTERNATIONAL. It focuses on changes to the AOAC Official Methods Program as adopted by the Board of Directors in 2011 and 2012, and touches on how they relate to the analytical communities, including those communities that form AOAC Sections. It also explains the opportunities available to work on standards development through AOAC stakeholder panels, and how to submit and move methods to “Official Method of Analysis” status.

AOAC INTERNATIONAL History

• Founded in 1884

• In 1991 became AOAC INTERNATIONAL

• 16 active sections worldwide

• Comprised of Analytical method-based communities

– Chemistry and microbiology methods

• More than 3,000 members worldwide including organizational members

– 1/3 of members reside outside of the U.S.

• Includes the AOAC Research Institute

AOAC - 1887 Meeting

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AOAC INTERNATIONAL is a globally recognized, 501(c)(3), independent, not-for-profit Association founded in 1884 to facilitate the resolution of trade disputes. Founded the Official Methods of AnalysisSM Program Originally Association of Official Agricultural Chemists In 1965 became Association of Official Analytical Chemists��Since 1991, the legal name is AOAC INTERNATIONAL. ��In 1884 the organization was established as the Association of Official Agricultural Chemists, our heritage. Later on, the name changed to the Association of Official Analytical Chemists, a reflection of our membership. Subsequently, the membership changed to include microbiologists, food science personnel as well as chemists. We also became an organization of international influence and membership, so, it was decided to change to the current legal name...AOAC INTERNATIONAL. While you may have seen that “AOAC” stands for the THE ASSOCIATION OF ANALYTICAL COMMUNITIES, this is only a statement to encompass all the scientific disciplines involved in doing the work of the Association, not a legal name. To attain the vision of “worldwide confidence in analytical results,” AOAC serves it’s stakeholders by providing the tools and processes necessary to collaborate and through consensus building, develop fit-for-purpose methods and services for ensuring quality measurements. This is AOAC’s mission. • In April 2014 the Central Section was revitalized. The Central Section covers Indiana, Kentucky, Michigan, Ohio, and West Virginia. In August 2013 the Pacific Southwest Section, which covers Arizona, California (exclusive of the area served by the Southern California Section), Colorado, Hawaii, Nevada, and Utah, was revitalized. �Leveraging the knowledge, experience, and expertise of more than 3,000 members with one-third of its members outside the United States, AOAC has developed a proven model to achieve its mission and vision and bring value to the analytical communities that it serves. The AOAC Research Institute is a wholly owned subsidiary of AOAC INTERNATIONAL that administers AOAC conformity assessment programs, AOAC Performance Tested Methods and AOAC Official Methods of Analysis for single source and proprietary methods. Today, there are more than 2,700 Official Methods of AnalysisSM

AOAC Organizational Affiliates as of April 11, 2014

1. 3M Food Safety2. AB SCIEX3. Abbott Nutrition4. Agilent Technologies, Inc.5. American Proficiency Institute6. Archer Daniels Midland

Company7. Bio-Rad Laboratories8. BioControl Systems, Inc.9. bioMérieux, Inc.10. Bruker Daltonics11. Canadian Food Inspection

Agency12. CEM Corporation13. Coca-Cola Company14. DuPont Nutrition & Health15. Elanco/Eli Lilly & Co.16. The Fertilizer Institute

17. Fonterra Cooperative Group Ltd.

18. General Mills, Inc.19. Health Canada20. Herbalife21. The Hershey Company22. Kellogg Company23. Kraft Foods Group / Mondelez

International24. Mars Botanical25. Mead Johnson Nutrition26. Merck KGaA - EMD Millipore27. Mérieux NutriSciences - Silliker28. Microbac Laboratories, Inc. 29. Microbiologics, Inc.30. MPI Research31. Neogen Corporation32. Nestle Research Center

33. NSF International34. NSI Lab Solutions, Inc. 35. Pepsi-Cola Company36. PerkinElmer, Inc.37. Q Laboratories, Inc.38. QIAGEN Gmbh39. R-Biopharm, Inc.40. ROMER Labs Division Holding

GmbH41. Shimadzu Scientific

Instruments, Inc.42. Starbucks Coffee Company43. Synutra International, Inc.44. Thermo Fisher Scientific45. Waters Corporation46. Wyeth Nutrition

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AOAC OAs are a cross-sector group representing food and beverage, dietary supplements, government agencies, technology providers, ingredient suppliers, contract research organizations, and test kit manufacturers. The OA program allows corporations, government agencies, and academic institutions to support the Association’s mission of advancing the global chemistry and microbiology analytical community by promoting standards development and quality measurements. AOAC and its Organizational Affiliates share the promise of an exciting future embodied in the concepts of Industry engagement, Involvement, Stakeholders, Problems and Solutions.��Organizational Affiliates have indeed grown into a group that can help solve problems in industry, regulation, as well as for individual companies, both in the US and worldwide through cooperation across their specific fields. AOAC does, and does what it does best, bring together key stakeholders, such as industry, regulators, and decision makers, to discuss their issues, needs, as well as identify and prioritize industry problems. This is perhaps the greatest benefit of being an AOAC Organizational Affiliate resulting in increased business for all while helping to solve the problems that inspired the cooperation. �

AOAC TODAY

• Solves problems by providing science based solutions

– Globally recognized

– Independent third party

• Standards Development

– Voluntary consensus through stakeholder panels and working groups

– Official and regulatory methods

• Conformity Assessment

– Official Methods of AnalysisSM

– Performance Tested MethodsSM

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Who we are� AOAC brings together government, industry, and other relevant stakeholders worldwide to reach consensus on method performance criteria, thus ensuring the methods that are needed are fit-for-purpose. This provides the buy-in and acceptance of decisions by the stakeholders. AOAC methods give defensibility, credibility, and confidence in decision-making because the performance and acceptance requirements are science-based.

What AOAC Does Not Do

• Regulate products

• Buy or sell food, beverage products, or proprietary technologies

• Promote specific food and beverage products

• Do risk assessments

• Set tolerance levels

• Own a laboratory or provide laboratory services

AOAC Products and Services

• Standards Development & Conformity Assessment

• Official Methods of AnalysisSM & Performance Tested MethodsSM

• Journal of AOAC INTERNATIONAL

• Regional Sections, Analytical Communities, and Technical Divisions

• AOAC Mid-Year Meeting & Annual Meeting and Exposition

• Laboratory Proficiency Testing, and Laboratory Accreditation Criteria

• Individual, Student, Sustaining & Organizational Memberships

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To increase confidence in analytical results, AOAC provides other tools to assess user competence in conducting the methods such as: An Annual Meeting and Mid Year Meeting, where members and non-members gather for education, networking and participation in various organizational activities. � AOAC publishes a renowned peer-reviewed scientific journal, The Journal of AOAC INTERNATIONAL as well as the Official Methods of AnalysisSM� The Accredited (by The American Association for Laboratory Accreditation (A2LA)) AOAC Laboratory Proficiency Testing Program (LPTP) , developed to meet the needs of analytical laboratories. The program helps laboratories achieve international credibility and compliance, when high quality homogeneous stable samples are combined with a commitment to provide responsive technical support and detailed reports. - Memberships are offered on an Individual and Corporate basis.

What’s New at AOAC?

• Voluntary consensus standards

• Standards Development structure

– Advisory Panels

– Stakeholder Panels

– Working Groups

– Expert Review Panels

• A New, Alternative Path to First Action Official MethodsSM

Before 2011

• Methods submitted to the Official Methods Program had two modes of entry:– Direct submission of protocol or manuscript to AOAC

INTERNATIONAL for peer review by a method centric committee.

– Submission of harmonized PTM report and drafted collaborative study protocol or manuscript for peer review.

• PTM program serves as the entry point for method validation.

• AOAC was gaining international recognition as a Standards Development organization.– Standard Method Performance Requirements identified.– Methods recommended to meet those standards were

“stuck” at the candidate stage.

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2011 was a milestone for AOAC and the Official Methods program. Prior to March 2011, there were two modes of entry for methods submitted to the OMA program. Methods were submitted from nonproprietary sources and method centric committees were appointed – charged with bringing those methods to First Action OMA status. Proprietary methods were submitted through the RI, were PTM certified and continued to OMA through the harmonized PTM/OMA program. In the meantime, AOAC standards development continued to successfully progress for a number of communities. Standard method performance requirements were developed but there was no direct way to connect stakeholders’ method requirements and achieving stakeholders’ method needs. Stakeholders needed Official Methods to address community based concerns and approved methods were challenging to produce.

New AOAC Policy in 2011

• Board of Directors formed a Task Force

– Consisting of former OMB chairs who are current members of the AOAC International Board of Directors

– Met in winter and spring of 2011

– Recommended the “Alternative Path to First Action Official Methods of Analysis”

• Board of Directors adopted the “Alternative Path to First Action Official Methods of Analysis” as policy in 2011

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Note the Successful implementation of “alternative pathway” as implemented: 27 methods approved as First Action OMA in 2011. 19 methods were approved using the “Alternative Path” since June 2011. 8 methods were adopted as First Action Official Methods through traditional routes to OMA. 4 methods through the traditional OMA process 4 methods through the PTM-OMA harmonized process

AOAC’s EVOLUTION

• AOAC relied on government contracts and conformity assessment (method validation).

• Shift to industry engagement and standards development activities.

• Sections and Communities provided opportunities to talk about specific needs.

• The engagement of industry created a need for a faster, consensus-based process as approval of Official MethodsSM was on a sharp decline.

• AOAC as an Association began providing more opportunities to “Talk About Methods” and ENGAGE.

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A brief review of the current environment in which AOAC”s business model has evolved: The reality is that AOAC resources are not limitless. If we squander our resources on projects that do not meet the current needs of the analytical communities we serve then we face the worst fate of all – irrelevance. The Association needs to focus on those projects that address an urgent need of a significant number of stakeholders. AOAC processes need to move faster. Stakeholders across all areas – industry, government and academia – need a place to come together where their common and conflicting requirements could be resolved and articulated.

1. Allows AOAC to focus on projects addressing an urgent need of a criticalmass of stakeholders.

2. Drives AOAC processes forward faster.3. Assembles stakeholders (industry,

government and academia) to neutral place to articulate and reach consensus onrequirements and resolve conflicts.

4. Those requirements are codified and are published as “Standard Method Performance Requirements” (SMPRs).

5. Methods are solicited that purport to meet those requirements.

6. Expert review panels (ERPs) judge the methods against the SMPRs. Method(s) that best meet the SMPRs are adopted and designated “First Action” Official Method of Analysis.

7. Process for First Action status to Final Action status follows as the same process for all AOAC First Action Official Methods.

AOAC Standards Development Process to Official MethodSM Status

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Review text on screen. Then In the year since the adoption of the new policy, it became clear that an additional option was needed to handle those few methods that come to AOAC from a single source rather than through a call for methods in response to the requirements established by a stake holder panel. With varying messages regarding sole source methods in the OMA program, it became clear that the OMA program required a unified approach to describe and define what has become an Official Methods program with the various processes depending on the source of the method and needs of the method developer. Furthermore, the process for sole source needed to be more streamlined and simplified. Questions arose such that it was time to take another critical look at the Official Methods program with respect to methods in the traditional process.

The Board Clarifies OMA Program

• Board of Directors task force reconvenes in August 2012

• Board of Directors meet to discuss the task force clarifications

• Board of Directors stipulate an effective date of September 7, 2012

• Follow up with OMB and Research Institute Board of Directors

Points of Clarification/Augmentation:• Expert Review Panels will review all

methods for all three modes of entry.• AOAC Research Institute will administer

the OMA program for methods entering:• Through the PTM-OMA harmonized

method submissions• Sole Source method submissions• AOAC INTERNATIONAL administers the

OMA program only for those methods entering through a response to an AOAC issued Call for Methods or in response to an approved voluntary consensus Standard Method Performance Requirements (SMPR).

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The Board of Directors has adopted the clearest, cleanest outline of AOAC INTERNATIONAL’s future to date. A single high level flowchart defines the pathways to standards development and method validation. Whether the end product required is a standard, a performance tested proprietary method or an Official Method of Analysis the process is transparent and equitable. Review text on screen.

Road to First Action OMA Status

Three modes of entry and (program administration)

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

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Presentation Notes

Here’s a high level overview of the unified process flow. You’ll note that those methods that come from single nonproprietary sources will now be directed to the RI for processing and handling. The authors will have access to the expert advice that is a hallmark of the Research Institute. Fees to be assessed will be clearly stated and will be advertised on the website. There are now three modes of entry for method submissions, all with differing processes. Through responding to an AOAC issued Call for Methods or an approved SMPR Through the PTM-OMA harmonized submission Through sole or single source method developer submission The criteria for adoption of methods is the fulfillment of the “Scope and Application” statement with the method. You will note that there are no Method Committees in this flowchart. It is the intention of the Board to phase out that pathway in the near future.

Standards Development & Method Approval

• New pathway to Official Methods status: – create standard (SMPRs) to judge methods.– collect relevant methods. – evaluate methods against SMPRs.

This is incredibly important. Minimum requirements reflecting the communities are now developed and documented (SMPRs) before a method is evaluated.

AOAC Standards Development

• Facilitates stakeholder engagement• Addresses community-specific issues• Process consists of transparency, openness, balance,

consensus, due process and appeals. • Voluntary consensus standards developed in the following

industries:– Commercial & Proprietary methods– Infant formula– Food industry– Homeland security & threat agents

AOAC Stakeholder Panels

• International Stakeholder Panel on Alternative Methods with Fresh Produce (ISPAM)

• International Stakeholder Panel on Alternative Methods with Fresh Produce (ISPAM-FP)

• Stakeholder Panel on Agent Detection Assays (SPADA)• Stakeholder Panel on Infant Formula and Adult Nutritionals

(SPIFAN)• Stakeholder Panel on Dietary Supplements (SPDS)• Stakeholder Panel on Strategic Food Analytical Methods

(SPSFAM)

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Updated: 4/11/2014

Advisory Panel

• Key stakeholder and identifies support;

• Acts as a steering committee -to frame the issues and agree on priorities for the stakeholder panel;

• Identifies stakeholders and subject matter experts;

• Recommends stakeholders as representative voting members.

Stakeholder Panel Composition

Stakeholder ChairSubject Matter Experts

Method DevelopersGovernment/Regulators

Method End UsersAcademia

Contract Research Organizations

NGOsOthers, as identified…

REFLECTIVE OF YOUR COMMUNITY

Research (international/

domestics; academic;

nonprofit, etc…)

Government (international/domestic;

surveillance, research, regulators, coordinators,

reference materials, emergency response,

federal/state/provincial/local, etc…)

Industry (international/

domestic; processors; CROs;

producers; method developers; raw

materials; reference materials; etc….)

Advisory Panel Stakeholder Panel

Publication of Standard Method

Performance Requirements

(SMPRs)

Working Groups

Standards Process Overview

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Presentation Notes

What’s different? � Process is More transparent More inclusive of stakeholders and community AOAC is not managing studies Process is driven by stakeholders but managed by AOAC staff The process is Industry driven

Stakeholder Panel Working Groups

• Subset of stakeholder panel;

• Can meet prior to stakeholder meeting;

• Will present motions to the stakeholder panel on draft standard method performance requirements;

• Can assist in identifying candidate methods that may likely meet the proposed SMPR and experts for the expert review panel.

Current AOAC Stakeholder Working Groups

• ISPAM Working Group on Microbiology Methods

• ISPAM Working Group on Statistics

• ISPAM-FP Working Group on Field Sampling Plan

• ISPAM-FP Working Group on Salmonella in Leafy Greens

• SPADA Working Group on First Response Field Capability

• SPADA Working Group on Variola

• SPDS Working Group on Anthocyanins

• SPDS Working Group on Chondroitin

• SPDS Working Group on PDE5 Inhibitors

• SPIFAN Working Group on Amino Acids

• SPIFAN Working Group on Carotenoids

• SPIFAN Working Group on Chloride

• SPIFAN Working Group on Fluoride

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Presentation Notes

Updated: 4/11/14

Documentation and Communication

• AOAC carefully documents the proceedings of the stakeholder panel and the working groups

• AOAC prepares summaries of the proceedings

– Communicate summaries to the stakeholders

– Publish summaries in the Referee section of AOAC’s Inside Laboratory Management

Stakeholder Panel Product

• Voluntary Consensus Standards

– Standard method performance requirements

– Published in Official Methods of AnalysisSM

– Manuscript published in Journal of AOAC INTERNATIONAL

AOAC Voluntary Consensus Standards

• Standard Method Performance Requirements (SMPRs) - most common standards

• Sampling procedures

• Guidelines

• Aligned with national and international laws for standards development

• All standards development activity is transparent and open. Official Methods Board assures balance and processes ensure due process and the ability to appeal decisions. Demonstration of consensus is documented.

• Published in Journal of AOAC INTERNATIONAL and in the Official Methods of Analysis

AOAC Voluntary Consensus Standards

SMPRs

• Documents a community’s analytical method needs

• Very detailed description of the analytical requirements

• Includes method acceptance requirements

• Used to qualify methods for AOAC approval under the Alternative Pathway model

• Published as a standard

SMPRs Format

• Stakeholders reach consensus on:– Intended use– Applicability– Analytical technique– Definitions– Method performance requirements table– System suitability– Reference materials– Validation guidance– Maximum time-to-determination

Performance Requirements Parameters for Quantitative Methods

• Analytical range• Limit of detection• Limit of Quantitation • Repeatability• Recovery• Reproducibility

All parameters have a minimum

requirement set by the Working Group

Expert Review Panel

• Reviews methods resulting from an AOAC issued Call for Methods

• Vetted by Official Methods Board for balance and conflicts of interest

• Candidate methods– Evaluated by the ERP and considered for First Action

Official MethodsSM status through the Alternative Pathway

– After 2 years, the ERP reviews any additional information (collaborative study, proficiency testing, or other documentation), makes recommendation to the Official Methods Board for Final Action status

AOAC Standards Development & First Action, Official MethodsSM Through Alternative Pathway

Advisory Panel Stakeholder Panel

Publication of Standard Method

Performance Requirements

Working Groups

Expert Review panel

First Action, Official

Methods status

After 2 years, ERP

recommends to AOAC Official

Methods Board to

award Final Action Status

What have AOAC Expert Review Panels Accomplished?

• 23 new Standard Methods Performance Requirements (SMPRs) and 41 new fit-for purpose AOAC First Action Official Methods of Analysis

– Infant formula

– Food Industry (antioxidant capacity)

• Published in Journal of AOAC INTERNATIONAL and beginning in the 19th Edition of OMA and in eOMA

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Presentation Notes

(tats current as of March 27, 2013. Check with AOAC HQ for latest updates in 2013.

Road to Final Action OMA Status

Method reproducibility must be demonstrated before Final Action consideration.

ERP determines if sufficient evidence merits a recommendation for Final Action status or repeal.

•Only the OMB promotes a method to “Final Action” status or repeal the method.

•Methods that did not meet the bar would be repealed.

•Same for all method submissions

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Presentation Notes

As you see here, from the point of adoption to First Action, All of the methods follow the same path to Final Action or Repeal.

How the China Section Engaged in this Process

Case Study:• A report on infant formula

testing in China was released in March 2012.

• Infant formula community came to AOAC to develop standard method performance requirements in March 2012.

• Agreement between AOAC and Infant formula industry signed in April 2012.

AOAC China Section:• AOAC China Section

coordinated submission of relevant Chinese methods.

• AOAC China Section coordinated participation of Chinese expert scientists and officials in the meetings.

• Chinese participation led to the approved standard.

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Presentation Notes

After the AOAC industry agreement was signed, AOAC issued a Call for Methods. �AOAC hosts working group, stakeholder panel and expert review panel meetings on the issue June 20-22, 2012. Draft standard was approved at these meetings. AOAC posted for stakeholder comment. AOAC China Section identified expertise to participate in the activities. AOAC China Section coordinated the participation of Chinese expert scientists and officials in the meetings 2nd planning meeting on May 23rd -24th in China. AOAC China Section coordinated submission of relevant Chinese methods. Chinese participation led to the approved standard.

Opportunities for Engagement in Standards Development in 2014

• AOAC Standards Development activities take place in the two days prior to the Annual Meeting.

• The AOAC Mid-Year Meeting takes place in the DC Metropolitan area every spring.

Learn More about AOAC INTERNATIONAL

• Inside Laboratory Management

• Journal of AOAC INTERNATIONAL

• Official Methods of AnalysisSM of AOAC INTERNATIONAL

• The Spectrum (e-newsletter)

• AOAC Website: www.aoac.org

• Twitter

• Facebook

• LinkedIn

http://www.aoac.org/

How to Participate

• ISPAM – International Stakeholder Panel on Alternative MethodsKrystyna [email protected]

• SPADA - Stakeholder Panel on Agent Detection AssaysKrystyna [email protected]

• SPDS - Stakeholder Panel on Dietary SupplementsDawn [email protected]

• SPIFAN - Stakeholder Panel on Infant Formula and Adult NutritionalsAnita [email protected]

• SPSFAM - Stakeholder Panel on Strategic Food Analytical MethodsDawn [email protected]

If you would like to participate as a stakeholder or on a working group or on a related expert review panel, please use the contacts.

For additional information on each group, please visit the AOAC website at www.aoac.org.

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Presentation Notes

Updated 4/7/14 ISPAM (International Stakeholder Panel on Alternative Methods) participants mainly from the test kit manufacturer community, international validation organizations…have worked on harmonized validation guidelines for both chemistry and micro validation. As part of ISPAM, in 2013, AOAC INTERNATIONAL identified produce safety as a high priority, and the AOAC Board of Directors approved an initiative, funded by the AOAC Research Institute, to develop analytical standards for produce safety. AOAC Fresh Produce project will develop a flexible, scientifically-sound, consensus-based and internationally acceptable microbiological sampling plan for the detection of Salmonella in leafy greens. � SPADA (Stakeholder Panel on Agent Detection Assays) establishes voluntary consensus standards for testing of polymerase chain reaction (PCR)-based technologies that detect aerosolized Variola, the virus that causes smallpox. SPDS (Stakeholder Panel on Dietary Supplements) is a 5-year contract with the National Institutes of Health-Office of Dietary Supplements (NIH/ODS) to establish voluntary consensus standards for high-priority ingredients, with the goal of obtaining First Action Official MethodsSM. This contract is expected to result in 25 standard method performance requirements (SMPRs) for priority dietary supplement ingredients. ��SPIFAN (Stakeholder Panel on Infant Formula and Adult Nutritionals) – participants mainly from infant formula industry, instrument manufacturers, CROs, global regulatory agencies, and topic experts. To address problems arising from different methods being used worldwide, many of which were technologically outdated. As of January 2013 SPIFAN developed 15 Standard Method Performance Requirements and 31 First Action Official Methods of Analysis on nutrients in infant and adult formula. SPSFAM (Stakeholder Panel on Strategic Food Analytical Methods) – participants from AOAC’s Organizational Affiliate members from multi-national food companies, instrument manufacturers, CROs, global regulatory agencies, and topic experts. Advisory Panel determines priorities to work on, thus far have worked on flavanols, heavy metals, vitamins/ingredients. The group has developed 7 SMPRs and 4 First Action Official Methods of Analysis.

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http://www.aoac.org/

Official Methods of Analysis of AOAC INTERNATIONAL, 19th Edition

In this edition you’ll find:• More appendices• Voluntary consensus

standards• More guidance

documents• More Fit for Purpose

Community Consensus-Based Methods

Laboratory Accreditation Criteria - ALACC

Available for purchase as an E-book via the AOAC Web

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Presentation Notes

The “AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2005 (2010)” (ALACC Guidelines) provides detailed information to aid in assessing the essential quality requirements for performing microbiological and chemical analyses of food and pharmaceuticals. The document is closely aligned with ISO/IEC 17025 and provides a section-by-section interpretation of the general ISO/IEC 17025 requirements.

For more information please contact:

AOAC INTERNATIONAL, [email protected]
