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The Presidential Task Force on Increasing Method Output developed guidance documents, which include a process flowchart and process guidelines, for the alternative pathway to achieving Official First Action Method status. Approved by the AOAC Board of Directors on May 25, 2011, the guidance documents outline requirements for ERPs (role, composition), decision to First Action status, and transition from First to Final Action status. Under the alternative pathway to achieving Official First Action status, ERPs have the authority—for the first time—to approve methods deemed satisfactory as AOAC Official Methods of AnalysisSM based on evaluation of the validation data available. As outlined in the guidance documents, ERPs, which are managed by AOAC Headquarters and whose members are properly vetted and approved by the Official Methods Board (OMB), will evaluate candidate methods (resulting from calls for methods and literature searches) against SMPRs developed by stakeholder panels and their working groups. These methods will already have good data to support their claims. Stakeholder panels are thoroughly vetted by the OMB, and like ERPs, all stakeholder panels and working groups are managed by AOAC Headquarters. ERPs consist of a minimum of seven members representing a balance of key stakeholders, and their meetings are open and transparent. Methods are carefully scrutinized by ERPs in a scientifically unbiased manner and measured against SMPRs (developed by stakeholders and working groups). Methods with available data adequately meeting SMPRs will be granted Official First Action status by ERPs. Methods approved under the alternative pathway will be published by AOAC INTERNATIONAL and remain First Action for a period of about 2-3 years. During this time, methods will be used in laboratories, generating additional data. In addition, ERPs will remain in force as long as a method is in First Action status. ERPs will monitor the performance of methods, and after 2-3 years, the ERPs will determine whether the method should be recommended to the OMB for Final Action. If the method is satisfactory, Final Action status is granted by the OMB. Alternately, ERPs can determine if methods need additional data to show reproducibility, which could be provided through proficiency testing or other data collection, for example. At the end of the 2-3 year period, methods will be retired if they do not perform satisfactorily, if no evidence of method use is available, or if data are not indicative of adequate method reproducibility. For more information about the guidance documents, as approved by the AOAC Board of Directors, contact Alicia Meiklejohn, AOAC executive office, at ameiklejohn@aoac.org. For the process flowchart,
CLICK HERE; for the process guidelines, CLICK HERE.
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