September 2015 SPADA Meeting

Comments Submitted (if any)

Line  Numbers 

SMPR 

Comments

ProposedResponse

Change 'Samples..' to 'Sample containers..'and 'randomlymixed  together..' to 'randomlyassociated..'because as is it stands it reads  like samplesare tobe mixed .

52 ‐ 53

Agreed.

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 There isno table III.  change table IV to table IIIand table V to table  IV;change textaccordingly State reason fornon‐applicabilityeven though itmay be obviousor  wouldbe if the typesof detectionwere indicatedat the documents  startnear l.3,e.g. immunochemical,mass spectroscopy?

Fordiscussion.  The current footnote does stae that"Some  aberrationsmaybe acceptable if the aberrationsare investigated,  andacceptable explanationscanbe determinedandcommunicated  tomethodusers."

58

Agreed.

SEA‐C

113

Agreed.

138

Table V is referred toasTable 4.Correct if necessary.

Agreed.

State currentcommerciallyavailable sources,  recognizing that  sourcesandavailabilitiesmay change in the future.Otherwise the  impression isgiven thatnone are available currently.

Table II. 

Propose to remove the "Commercial availability"column.

Motion

• Move to accept the Standard Method  Performance Requirements for  Staphylococcal Enterotoxin A‐C as  presented.