AOAC INTERNATIONAL. A 2014 Overview. As of April 2014

Transcription

1 AOAC INTERNATIONAL A 2014 Overview As of April 2014

2 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 Meeting

3 AOAC Organizational Affiliates as of April 11, M 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 Nutrition & Health 15. Elanco/Eli Lilly & Co. 16. The Fertilizer Institute 17. Fonterra Cooperative Group Ltd. 18. General Mills, Inc. 19. Health Canada 20. Herbalife 21. The Hershey Company 22. Kellogg Company 23. Kraft Foods Group / Mondelez International 24. Mars Botanical 25. Mead Johnson Nutrition 26. Merck KGaA - EMD Millipore 27. Mérieux NutriSciences - Silliker 28. Microbac Laboratories, Inc. 29. Microbiologics, Inc. 30. MPI Research 31. Neogen Corporation 32. Nestle Research Center 33. NSF International 34. NSI Lab Solutions, Inc. 35. Pepsi-Cola Company 36. PerkinElmer, Inc. 37. Q Laboratories, Inc. 38. QIAGEN Gmbh 39. R-Biopharm, Inc. 40. ROMER Labs Division Holding GmbH 41. Shimadzu Scientific Instruments, Inc. 42. Starbucks Coffee Company 43. Synutra International, Inc. 44. Thermo Fisher Scientific 45. Waters Corporation 46. Wyeth Nutrition

4 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 Analysis SM Performance Tested Methods SM

5 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

6 AOAC Products and Services Standards Development & Conformity Assessment Official Methods of Analysis SM & Performance Tested Methods SM 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

7 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 Methods SM

8 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.

9 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

10 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 Methods SM was on a sharp decline. AOAC as an Association began providing more opportunities to Talk About Methods and ENGAGE.

11 AOAC Standards Development Process to Official Method SM Status 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.

12 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).

13 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.

14 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.

15 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

16 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)

17 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.

18 Stakeholder Panel Composition Industry (international/ domestic; processors; CROs; producers; method developers; raw materials; reference materials; etc.) Research (international/ domestics; academic; nonprofit, etc ) Government (international/domestic; surveillance, research, regulators, coordinators, reference materials, emergency response, federal/state/provincial/local, etc ) Stakeholder Chair Subject Matter Experts Method Developers Government/Regulators Method End Users Academia Contract Research Organizations NGOs Others, as identified REFLECTIVE OF YOUR COMMUNITY

19 Standards Process Overview Advisory Panel Stakeholder Panel Publication of Standard Method Performance Requirements (SMPRs) Working Groups

20 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.

21 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

22 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

23 Stakeholder Panel Product Voluntary Consensus Standards Standard method performance requirements Published in Official Methods of AnalysisSM Manuscript published in Journal of AOAC INTERNATIONAL

24 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

25 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

26 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

27 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

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29 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 Methods SM 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

30 AOAC Standards Development & First Action, Official Methods SM Through Alternative Pathway Advisory Panel Stakeholder Panel Publication of Standard Method Performance Requirements Expert Review panel First Action, Official Methods status After 2 years, ERP recommends to AOAC Official Methods Board to award Final Action Status Working Groups

31 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

32 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

33 How the China Section Engaged in this Process Case Study: A report on infant formula testing in China was released in March Infant formula community came to AOAC to develop standard method performance requirements in March Agreement between AOAC and Infant formula industry signed in April 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.

34 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.

35 Learn More about AOAC INTERNATIONAL Inside Laboratory Management Journal of AOAC INTERNATIONAL Official Methods of Analysis SM of AOAC INTERNATIONAL The Spectrum (e-newsletter) AOAC Website: Twitter Facebook LinkedIn

36 How to Participate ISPAM International Stakeholder Panel on Alternative Methods Krystyna McIver SPADA - Stakeholder Panel on Agent Detection Assays Krystyna McIver kmciver@aoac.org SPDS - Stakeholder Panel on Dietary Supplements Dawn Frazier dfrazier@aoac.org SPIFAN - Stakeholder Panel on Infant Formula and Adult Nutritionals Anita Mishra amishra@aoac.org SPSFAM - Stakeholder Panel on Strategic Food Analytical Methods Dawn Frazier dfrazier@aoac.org 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

37 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

38 Laboratory Accreditation Criteria - ALACC Available for purchase as an E-book via the AOAC Web

39 For more information please contact: AOAC INTERNATIONAL,