AOAC INTERNATIONAL A 2013 Overview As of July 1, 2013
AOAC INTERNATIONAL
A 2013 Overview As of July 1, 2013
AOAC INTERNATIONAL History
• In 1991 became AOAC INTERNATIONAL
• 14 active sections worldwide
• Comprised of Analytical method-based communities
– Chemistry and microbiology methods
• More than 3000 members worldwide including organizational members
– 1/3 of members reside outside of the U.S.
• Includes the AOAC Research Institute
AOAC Organizational Affiliates Members as of July 1, 2013
1. 3M Food Safety 2. AB SCIEX 3. Abbott Nutrition 4. Agilent Technologies, Inc. 5. American Proficiency
Institute 6. Archer Daniels Midland
Company 7. Bio-Rad Laboratories 8. BioControl Systems, Inc. 9. bioMérieux, Inc. 10. Bruker Daltonics 11. Canadian Food Inspection
Agency 12. CEM Corporation 13. Coca-Cola Company 14. DuPont Qualicon 15. Elanco/Eli Lilly & Co.
16. Eurofins Scientific, Inc. 17. Fonterra Cooperative
Group Ltd. 18. General Mills, Inc. 19. Health Canada 20. Hershey Center for
Health And Nutrition 21. Kellogg Company 22. KPL, Inc. 23. Kraft Foods Group /
Mondelez International 24. Mars Botanical 25. Mead Johnson Nutrition 26. Merck KGaA - EMD
Millipore 27. Microbac Laboratories,
Inc. 28. Microbiologics, Inc.
29. MPI Research 30. Neogen Corporation 31. Nestle Research Center 32. NSF International 33. NSI Solutions 34. Pepsi-Cola Company 35. Perkin Elmer, Inc. 36. QIAGEN Gmbh 37. R-Biopharm, Inc. 38. Schiff Nutrition
International 39. Starbucks Coffee Company 40. The Fertilizer Institute 41. Thermo Fisher Scientific 42. Waters Corporation 43. Wyeth Nutrition
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
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
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.
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
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.
1. Allows AOAC to focus on projects addressing an urgent need of a critical mass of stakeholders.
2. Drives AOAC processes forward faster.
3. Assembles stakeholders (industry, government and academia) to neutral place to articulate and reach consensus on requirements 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
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).
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.
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 (ISPAM)
• Stakeholder Panels on Agent Detection Assays (SPADA)
• Stakeholder Panels on Infant Formula and Adult Nutritionals (SPIFAN)
• Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM)
• Stakeholder Panel on Marine and Freshwater Foods (SPMFF)
• Stakeholder Panel on Veterinary Drug Residues in Animal Tissues (SPVDR)
• Stakeholder Panel on Endocrine Disruptors (SPED)
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 Chair
Subject Matter Experts
Method Developers
Government/Regulators
Method End Users
Academia
Contract Research Organizations
NGOs
Others, 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
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 WG on Microbiology • ISPAM WG on Qualitative
Chemistry • ISPAM WG on Statistics • SPADA WG on Bacillus anthracis • SPADA WG on Francisella tularensis • SPADA WG on Yersinia pestis • SPADA WG on Environmental
Factors • SPADA WG on Ricin Hand held
assays • SPADA WG on Bacillus anthracis
Hand held assays • SPADA WG on Burkholderia • SPADA WG on Assay Controls • SPADA WG on Variola • SPIFAN WG on Vitamin A • SPIFAN WG on Vitamin D • SPIFAN WG on Vitamin B12
• SPIFAN WG on Folic acid • SPIFAN WG on Inositol • SPIFAN WG on Vitamin E • SPIFAN WG on Nucleotides • SPIFAN WG on Ultra Trace Minerals • SPIFAN WG on Pantothenic acid • SPIFAN WG on Iodine • SPIFAN WG on Carnitine • SPIFAN WG on Whey protein-Casein
Ratio • SPSFAM WG on Antioxidants • SPSFAM WG on Flavanoids • SPSFAM WG on Ingredients • SPSFAM WG on Heavy Metals • SPSFAM WG on Priority Response • SPSFAM WG on St. John’s Wort
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
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
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.
Opportunities for Engagement in Standards Development
• 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.
August 25 - 28, 2013 Palmer House Hilton, Chicago, Illinois
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
How to Participate
• ISPAM – International Stakeholder Panel on Alternative Methods Krystyna McIver [email protected]
• SPIFAN - Stakeholder Panel on Infant Formula and Adult Nutritionals Anita Mishra [email protected]
• SPSFAM - Stakeholder Panel on Strategic Food Analytical Methods Dawn Frazier [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.
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
For more information please contact: AOAC INTERNATIONAL, [email protected]
Thank you!