OMB Meeting Book (June 25-26, 2015)

ERP Final Action Recommendation Report for AOAC Official Method 2012.16, Pantothenic 1 Acid (Vitamin B5) in Infant Formula and Adult/Pediatric Nutritional Formula – Ultra- 2 Performance Liquid Chromatography – Tandem Mass Spectrometry Method (First Action 3 2012) 6 AOAC Official Method 2012.16, Pantothenic Acid (Vitamin B5) in Infant Formula and Adult/Pediatric 7 Nutritional Formula (AOAC 2012.16) was originally a method submitted by Nestle Research Center in 8 Switzerland in response to a Call for Methods that purported to meet the standard method performance 9 requirements (SMPR) for pantothenic acid (AOAC 2012.009) established by the AOAC Stakeholder Panel 10 on Infant Formula and Adult Nutritionals (AOAC SPIFAN) in 2012. The method was reviewed by the 11 AOAC Expert Review Panel for SPIFAN Nutrient Methods (ERP) and was judged to have sufficiently met 12 the AOAC 2012.009. The ERP adopted the method, making it an AOAC First Action Official Methods of 13 Analysis . 14 15 The ERP tracked this method for two years. During this time, the method was published in the Official 16 Methods of Analysis of AOAC INTERNATIONAL (OMA) and in the Journal of AOAC INTERNATIONAL 17 (Journal). Additionally, a manuscript with a method comparison of AOAC 2012.16 to the traditional 18 microbiological reference assay, AOAC 992.07, a microbiological assay was published in the Journal. This 19 comparison was reviewed by the ERP and they determined that any suggestions and modifications could 20 be addressed as the method moved forward for reproducibility assessment in a multi-laboratory study. 21 22 In March 2015, the ERP reviewed the method and all data supporting the method’s reproducibility. In 23 preparation for the discussion, AOAC has listed the method in the Referee Section of the AOAC Inside 24 Laboratory Management publication as the method selected for multi-laboratory testing and 25 subsequently as the method likely to be considered for Final Action recommendation by the ERP. 26 Additionally, AOAC sent out two email blasts to its member and network database (>5,000 contacts) to 27 solicit feedback on the method from users of the method. No feedback was received as a result of these 28 efforts. Additionally, ERP members were asked to review the method using a form that is based on the 29 OMB’s guidance to ERPs for First to Final Action (OMA Appendix G). The ERP did discuss some feedback 30 from meeting attendees. The one comment that the ERP thought should be clarified in the method is 31 adding a comment regarding ensuring the the drying and ensuring the moisture content of the Calcium 32 pantothenate standard before use. It was agreed that clarifications would be provided in the method 33 4 5 EXECUTIVE SUMMARY:

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