OMB Meeting Book - January 8, 2015

78

Updating the Official Methods Of Analysis SM Archiving or Repealing Superseded Methods

Background The Official Methods of Analysis SM (OMA) are the recognized gold standard for dispute resolution methods. “For over 125 years AOAC INTERNATIONAL has been meeting the needs of its members and scientists throughout the world for confidence in analytical results by delivering AOAC® Official Methods SM . The Official Methods of Analysis of AOAC INTERNATIONAL (OMA) is an international source of methods and voluntary consensus standards, with many countries and international organizations contributing their expertise. OMA is the most comprehensive and reliable collection of chemical and microbiological methods available in the world and are contained in many of the Codex food standards.” Maintaining the OMA as current is vital to protect the AOAC brand on the international stage. Stakeholder Panels have been formed as the result of industry or government agencies seeing a need to address an urgent problem. Two panels have been formed by AOAC INTERNATIONAL and the Research Institute in a commitment to invest in the AOAC brand. Once standard method performance requirements have been published and methods are identified to meet those requirements there is one additional task to meet. Industry leaders have come to realize that within the Official Methods of Analysis SM there remain a number of Official Methods that have been superseded. Either the older technologies are no longer viable or the older methods give significantly different results. This could well engender a costly dispute where one Laboratory has used the newly recognized method and another Laboratory has used the older method. There is no obvious way to alert the customers, the laboratories, regulatory agencies and indeed even the courts to know how to evaluate the differences. This paper proposes a systematic process for dealing with this problem before disputes arise. Proposal Stakeholder Panels invest a great deal of capital and time to ensure that the methods identified meet the needs of their analytical community. Additional investment is required to make sure that the methods that remain in OMA are the best methods available. This proposal does not preclude a standing Working Group from proposing the withdrawal of a method from OMA. However the review of that recommendation by a Stakeholder Panel, Expert Review Panel and the Official Methods Board should remain a standard pathway for this process. It does preclude having such decisions arising from a petition from a single individual or interest. 1) Once methods have been chosen to go to final action, the stakeholder panel should send a new task to the original working group or even empanel a new working group. 2) The task of this Working Group would be to identify methods in OMA that no longer meet the new Standard Method Performance Requirements. 3) The list of non-conforming methods would then go to the Stakeholder Panel for ratification. 4) The Expert Review Panel would then recommend to the Official Methods Board one of three options. Accuracy and viability are the factors that need to inform those decisions. Valid technical and/or strategic reasoning should accompany each recommendation. a) Retain the method. b) Repeal/withdraw the method. c) If the method can meet the new standards with some modification, then it must be sent through the method modification pathway.