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