2018 August 26 SPSFAM Book

Responses to Submitted Comments

TypesofComments CommentorConcern (Justification forChange ‐IncludeLineNumber if  Applicable)

ProposedChange(s) ‐Please  include linenumber(s)

Response

Editorial

1)Line 20/21 :  There´s anextra space in .." residue / matrix" 2)Paragraphs  3 to7 : the text arenot justified

1)Line20/21:eliminate the  espace : "residue/matrix"

Changeas suggested.

2)Paragraphs3 to7 :  suggestion: justify text 

Technical

Table 1under line 48: Why at0.5xMRL the POD 

Specify tandem MS/MS with  HRMS canbe used aswell CanUSFDA andEU  guidelines forHMRS  confirmationbe cited here? Lines50‐51: Includeexplanation  ofhow the resultof this  calculation will beused. Lines54‐55:Usemore specific  language todescribe how the  check samples should be  prepared. Line55:Considerusing  "acceptability criteria" or  something similar.  Lines83‐84:Usemore specific  language todescribe how  retention timesand ion ratios  should bedetermined.  Table2:Considerusing "chicken  egg".Allothermatriceshave  thenameof the species spelled  out (e.g.chickenmuscle).Also  consider using "whole egg" to  removeanyambiguity regarding  whichpartsof theegg (white,  yolk,whole) should beanalyzed. 

Lines 54‐55: Change to "Suitable methods will  include blank check samples and check standards at  0.5x and 1.0x MRL prepared in matrix." Table 2:  Change "Raw Egg" to "Raw Whole Chicken Egg"

Technical Editorial

Lines 50‐51:All incorrect results must be investigated to  determine the concentration atwhichPOD90with 95%  confidence is achieved. It is unclear whatwillbe done next, once  this concentration isdetermined. Howwill this calculation  determine the acceptability (or lack thereof) of the method?  Lines 54‐55:Are the blank, 0.5xMRL,and 1.0xMRL check  samples going tobe prepared in neat solvent or in each relevant  matrix? Line 55:The term "cutoff" is not the best choice here. Lines 83‐84:Are retention times and ion ratios tobe determined 

in neat solvent or in each relevant matrix? Table 2: Is "egg" sufficiently unambiguous?

Motion

• Move to accept the Standard  Method Performance  Requirements for  Screening and  Identification Methods for  Regulated Veterinary Drug  Residues in Food as presented.