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AOAC ushered in a new era of standards development and conformity assessment with the adoption of nine Official MethodsSM for the first set of priority nutrients in infant formulas and adult/pediatric nutritional formulas using the alternative pathway to First Action status. Under this new approach, expert review panels (ERP) now have the authority--for the first time--to approve methods deemed satisfactory as AOAC First Action Official MethodsSM based on evaluation of the validation data available. On June 29, 2011, as part of the “Standards Development and International Harmonization: AOAC INTERNATIONAL Mid-Year Meeting,” the inaugural ERP charged with granting First Action status evaluated methods against standard method performance requirements (SMPRs). All candidate methods for vitamins A, B12, and D, and folic acid were approved, while methods for inositol will be further evaluated during the AOAC Annual Meeting in September 2011. The groundbreaking achievement sets the momentum for AOAC’s many other funded stakeholder activities. "This is a momentous occasion for AOAC,”" agreed Darryl Sullivan of Covance Laboratories and AOAC Executive Director James Bradford. "These new methods are world-class and have plenty of good data, but, for the first time, no collaborative study. We have really opened up the world of analytical chemistry to better serve industries. This is an extraordinary step for AOAC and one that is valuable to the Association’s other stakeholders, like the food industry, who can achieve the same results." During the mid-year meeting in June 2011, an ERP, which was thoroughly vetted by the Official Methods Board, agreed by consensus on methods for First Action approval. Fitness-for-purpose statements and SMPRs were meticulously developed by the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) and its working groups against which candidate methods (recommended by nutrient-specific working groups) were reviewed. All methods were reviewed by a primary and secondary expert reviewer. Methods were evaluated for completeness of validation and likelihood of meeting SMPRs (appropriateness for the intended use, clarity of the method description, repeatability, reproducibility, recovery, analytical range, and limits of detection and quantitation). In addition, the ERP recommended additional performance data needed to advance the methods from First to Final Action status. Approved methods have been codified and will be drafted into AOAC-style for publication in the Journal of AOAC INTERNATIONAL and Official Methods of AnalysisSM. During the AOAC Annual Meeting in New Orleans, Louisiana, USA, in September 2011, an ERP will evaluate methods for inositol, as well as for vitamin E, ultra trace elements, and nucleotides, for possible adoption as First Action under the new alternative pathway. With this new process, AOAC is relying on the combined expertise and scientific judgment of the ERPs. The alternative path allows AOAC to better and quickly solve problems for stakeholders by making good--and urgently needed--methods available to laboratories. "There are tremendous opportunities for AOAC and its members and customers with the new alternative path," said Sullivan. "If approved, laboratories can start using these much needed methods, and we can gather additional information and learn a great deal." For more information on AOAC’s infant formula initiative and/or SPIFAN, contact Anita Mishra, executive for scientific business development, at amishra@aoac.org or Deborah McKenzie, senior director of methods development and approval processes, at dmckenzie@aoac.org. For more information about the alternative pathway to First Action status, contact Alicia Meiklejohn, AOAC executive office, at ameiklejohn@aoac.org. Full coverage is scheduled for the July/August 2011 issue of Inside Laboratory Management.
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