AOAC OMA# 2011.14 (Final Action Review)-OMB

2011.14 (Oct. 2018) – MTE-03 Final Action Review FOR ERP USE ONLY DO NOT DISTRIBUTE

SPIFAN Matrixes.- Laboratory 2 had outliers by the Cochran test for all elements in infant elemental powder and in partially hydrolyzed milk-based infant powder (infant PH powder milk) for all elements except Mg, which was invalid due to a negative value. Nearly all invalid data (e.g., negative values) were observed in the placebo samples, especially the infant elemental powder placebo and the infant RTF placebo, due to the low levels of Cu, Fe, Mn and Zn. Laboratory 9 produced data for infant PH powder milk that was 10-fold higher than the other laboratories, but did not respond to queries, so the data were excluded. A summary of results and statistical analyses by element and product are presented in Tables 2011.14A-I. In the fortified SPIFAN matrixes, the RSD r values ranged from 0.9% for Ca in infant PH powder milk and Mn in Adult powder low fat to 8.46% for Ca in infant RTF milk. Reproducibility (RSD R ) ranged from 4.11% for Zn in infant RTF milk to 23.7% for Mn in infant powder milk, with the exclusion of Ca in adult RTF high fat. This matrix was problematic due to the large amount of insoluble tricalcium phosphate, which separates easily and is difficult to homogenize (9). HorRat values ranged from 0.33 for Mn in infant powder soy to 2.05 for Ca in infant RTF milk. In the placebo matrixes, repeatability ranged from 0.9% for Na in adult RTF high protein placebo to 32.9% for Cu in infant RTF placebo and reproducibility ranged from 2.5% for P in adult RTF high fat placebo to 95% for Cu in infant elemental powder placebo. HorRat values ranged from 0.30 for Mn in adult RTF high protein placebo to 3.66 for Cu in infant elemental powder placebo. Excluding data for Cu, Fe, Mn, and Zn, the HorRat values ranged from 0.42 for P in adult RTF high fat placebo to 1.77 for Ca in adult RTF high protein placebo. Table 4 summarizes the overall results by element for the SPIFAN