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Comments Submitted (if any)
SMPR
Line
Numbers
Comments
ProposedResponse
52 ‐ 53
Change 'Samples..' to 'Sample containers..'and 'randomlymixed
together..' to 'randomlyassociated..'because as is it stands it reads
like samplesare tobe mixed
Agreed.
.
58
If non‐target relatedSE toxin(s) were testedpositive below10x the
AMDL thisdoesnot strictlyexclude amethod tomeet the
requirementsof thisSMPR.The methoddevelopermay
communicate this result from the selectivity study to the method
user. Iinsert second footnote forAMDLof non‐targetcompounds
Fordiscussion. The current footnote does stae that"Some
aberrationsmaybe acceptable if the aberrationsare investigated,
andacceptable explanationscanbe determinedandcommunicated
tomethodusers."
There isno table III. change table IV to table IIIand table V to table
IV;change textaccordingly
Agreed.
113
State reason fornon‐applicabilityeven though itmay be obviousor
wouldbe if the typesof detectionwere indicatedat the documents
startnear l.3,e.g. immunochemical,mass spectroscopy?
Agreed.
SEA‐C
138
Table V is referred toasTable 4.Correct if necessary.
Agreed.
Table II.
State currentcommerciallyavailable sources, recognizing that
sourcesandavailabilitiesmay change in the future.Otherwise the
impression isgiven thatnone are available currently.
Propose to remove the "Commercial availability"column.
Motion
•
Move to accept the Standard Method
Performance Requirements for
Staphylococcal Enterotoxin
A‐C as
presented.