OMB Meeting Book (June 25-26, 2015)

number of stakeholders were and continue to be in attendance for discussion on these methods during 1 the ERP meetings. Please refer to ERP reports.

2 3

SAFETY CONCERNS: 4 A. A safety review must be performed for a method to be recognized as First Action. 5 6 ERP has addressed all safety concerns were addressed prior to and as part of the two year period. 7 Appropriate warnings, precautionary statements, and instructions are included in the method. The 8 method includes a number of precautions on the use of ovens and microwaves, the use caustic acids 9 and bases, and on the need for cooling of samples that have undergone oven or microwave digestion. 10 Method users are also instructed to consult the MSDS prior to using chemicals and to adhere to the 11 safety precautions provided therein. In addition, method users are also instructed to where personal 12 protective equipment when necessary. 13 14 B. All safety concerns identified during the 2 year evaluation period must be addressed. 15 16 Discussions on method safety transpired during the meeting during which the method was adopted and 17 subsequently when the method was selected for the tract to Final Action recommendation. Please see 18 the Method Evaluation spreadsheet 2 developed by the formula manufacturers to aid the ERP in down 19 selecting one method per nutrient. 20 21 C. Guidance and support can be obtained from the AOAC Committee on Safety. 22 23 In addition to the expertise of ERP members’ familiarity with the safety issues around chemicals used in 24 this method, the AOAC Method Safety and Risk Assessment Guide 3 was provided and served as 25 reference for method authors and ERP members. 28 A. Document efforts undertaken to locate reference materials. Method may still progress to Final 29 Action even if reference materials are not available. 30 2 Method Evaluation Form for AOAC 2012.15, Total Iodine in Infant Formula and Adult/Pediatric Nutritional Formula Using ICP- MS 3 AOAC Method Safety and Risk Assessment Document 26 27 REFERENCE MATERIALS:

3