335 / 596
3. Page 7, line 33. Blending, stomaching and
hand mixing can give significantly different
results with certain commodities. This is
particularly the case with leafy greens and
seeds. If different types of homogenization
were used for different commodities then they
should specifically be listed in the method. Only
sample preparation procedures that were used
in the PTM and OMA validation studies can be
specified in the instructions, since that is what
was validated. "Table A" would be the
appropriate location for this information.
Added subscript/footnote explanations of
which products were homogenized by
stomaching, vortexing, and hand massaging.
PTM 111501 indicates (Page 11, line 12-16) that
"all" 25 and 125g food samples were
homogenized by stomaching, so stomaching
should be indicated for these products. It is not
clear how the cantaloupes were prepared.
Currently revising the PTMs to reflect the
method of homognization. See above
response.
4. Page 9, Table 2. There is no Table 1, so how
can there be a Table 2? Moreover, Page7/line
34 refers to "Table A" which appears to be in
the Table found on page 9. Please make sure
that the instructions on page 7 refer the reader
to the correct table.
Revised Table 2 to Table A. (five instances)
5. Page 9, Table 2. Please be sure to add a
sample preparation column that specifies
homogenization procedures for the different
commodities if different sample prep
procedures were used in the validation studies.
Added subscript/footnote explanations of
which products were homogenized by
stomaching, vortexing, and hand massaging.
ER4 Package Insert comments:
1. Page 9, line 3. It appears that the method
was validated with a sample preparation
procedure that only included stomaching,
except cantaloupes, so "blending" should be
removed from the instructions. I believe that
hand mixing is appropriate for cantaloupes, but
this must be spedified in the method.
Added subscript/footnote explanations of
which products were homogenized by
stomaching, vortexing, and hand massaging.
OMMAN-29