OMB Meeting Book (June 25-26, 2015)

ERP Final Action Recommendation Report for AOAC Official Method 2012.15, Total Iodine in 1 Infant Formula and Adult/Pediatric Nutritional Formula – Inductively Coupled Plasma - Mass 2 Spectrometry Method (First Action 2012) 5 AOAC Official Method 2012.15, Total Iodine in Infant Formula and Adult/Pediatric Nutritional Formula by 6 Inductively Coupled Mass Spectrometry (AOAC 2012.15) was originally a method submitted by Covance 7 Laboratories in Wisconsin, USA in response to a Call for Methods that purported to meet the standard 8 method performance requirements (SMPR) for total iodine (AOAC 2012.008) established by the AOAC 9 Stakeholder Panel on Infant Formula and Adult Nutritionals (AOAC SPIFAN) in 2012. The method was 10 reviewed by the AOAC Expert Review Panel for SPIFAN Nutrient Methods (ERP) and was judged to have 11 sufficiently met the AOAC 2012.008. The ERP adopted the method, making it an AOAC First Action 12 Official Methods of Analysis. 13 14 The ERP tracked this method for two years. During this time, the method was published in the Official 15 Methods of Analysis of AOAC INTERNATIONAL (OMA) and in the Journal of AOAC INTERNATIONAL 16 (Journal). Additionally, a single laboratory validation using the SPIFAN matrices was conducted and a 17 report submitted. This report was reviewed by the ERP and they determined that any suggestions and 18 modifications could be addressed as the method moved forward for reproducibility assessment in a 19 multi-laboratory study. 20 21 In March 2015, the ERP reviewed the method and all data supporting the method’s reproducibility. In 22 preparation for the discussion, AOAC has listed the method in the Referee Section of the AOAC Inside 23 Laboratory Management publication as the method selected for multi-laboratory testing and 24 subsequently as the method likely to be considered for Final Action recommendation by the ERP. 25 Additionally, AOAC sent out two email blasts to its member and network database (>5,000 contacts) to 26 solicit feedback on the method from users of the method. No feedback was received as a result of these 27 efforts. Additionally, ERP members were asked to review the method using a form that is based on the 28 OMB’s guidance to ERPs for First to Final Action (OMA Appendix G). The ERP did discuss some feedback 29 from meeting attendees and concluded that there needed to be some additional clarifications to the 30 method as it pertained to applicable samples, maintenance of the lens stack and instrument 31 conditioning, use of second source standards, use of peristaltic pump tubing sizes and potential need for 32 a dedicated set of cones and lenses. These clarifications have been accepted and incorporated into the 33 3 4 EXECUTIVE SUMMARY:

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