OMB Meeting Book (June 25-26, 2015)

A. A safety review must be performed for a method to be recognized as First Action. 1 2 ERP has addressed all safety concerns were addressed as part of the two year period. Appropriate 3 warnings, precautionary statements, and instructions are included in the method. Method users are 4 instructed to consult the MSDS prior to using chemicals and to adhere to the safety precautions 5 provided therein. Method users are also instructed to where personal protective equipment when 6 necessary. 7 8 B. All safety concerns identified during the 2 year evaluation period must be addressed. 9 10 Discussions on method safety transpired during the meeting during which the method was adopted and 11 subsequently when the method was selected for the tract to Final Action recommendation. Please see 12 the Method Evaluation spreadsheet 2 developed by the formula manufacturers to aid the ERP in down 13 selecting one method per nutrient. 14 15 C. Guidance and support can be obtained from the AOAC Committee on Safety. 16 17 In addition to the expertise of ERP members’ familiarity with the safety issues around chemicals used in 18 this method, the AOAC Method Safety and Risk Assessment Guide 3 was provided and served as 19 reference for method authors and ERP members. 22 A. Document efforts undertaken to locate reference materials. Method may still progress to Final 23 Action even if reference materials are not available. 24 25 During its second meeting in April 2011, SPIFAN approved the first of the five SMPRs in which NIST 26 Infant formula SRM 1849 and now SRM 1849a was the stated at the primary reference material. This 27 SRM is stated as the primary reference material in all SPIFAN SMPRs. The NIST SRM 1849a material was 28 tested in the reproducibility assessment for AOAC 2012.16 4 . 29 2 Method Evaluation Form for AOAC 2012.16, Pantothenic acid (Vitamin B5) in Infant Formula and Adult/Pediatric Nutritional Formula UHPLC-MS/MS 3 AOAC Method Safety and Risk Assessment Document 4 Data report for assessing AOAC 2012.16 with NIST SRM 1849a 20 21 REFERENCE MATERIALS:

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