OMB Monthly Meeting (April 14, 2016)
OMB Teleconference Materials
Attachment 3
ERP SUMMARY FOR FIRST TO FINAL ACTION METHOD RECOMMENDATION
AOAC 2012.25
Residues of Three Triphenylmethane Dyes and Their Metabolites (Malachite
Green, Leuco Malachite Green, Crystal Violet, and Brilliant Green) in Aquaculture Products
GUIDANCE FOR AOAC ERPS - APPENDIX G 1 Considered?
Comments/Reference if applicable
Triphenylmethane dyes as specified in applicability statement.
Method Applicability
Yes
ERP First to Final Action recommendations & improvements implemented/addressed
Draft Final Action method reviewed by ERP
Safety Concerns
Yes Yes
Completed and discussed during ERP meeting Currently no reference materials available for these types of drugs Hurtaud-Pessel et al., J. AOAC Int . 96 , 1152(2013) Andersen et al., J. AOAC Int . 98 , 636(2015) H modification H matrix extension Schneider & Andersen J. AOAC Int . 98 , 658(2015)
ReferenceMaterials
Single Laboratory Validation
Yes
Reproducibility/Uncertaintyand Probability of Detection
Yes
SMPR 2009.001 H SMPR for Quantitative Methods for Drug Residues in Shrimp, Tilapia, Catfish, and Salmon; SMPR criteria met according to ERP
Comparison to SMPR ( SMPR criteria metI)
Yes
Discussed in ERP Meeting
Feedback fromUsers of Method
Yes
Comments
DOCUMENTATION Safety Evaluation ReferenceMaterials
Available?
Completed; Discussed in ERP meeting
Yes No Yes
None specified in SMPR; none available
Hurtaud-Pessel et al., J. AOAC Int . 96 , 1152(2013) Andersen et al., J. AOAC Int . 98 , 636(2015) Used SMPR; OMA appendix D, and help from Chemical Contaminants Community subgroup
SLV or PTMs
Approved Validation Protocols
No
Completed
Statistics Review
Yes Yes Yes
2012.25
Method Published in OMA
SMPR 2009.001 H SMPR for Quantitative Methods for Drug Residues in Shrimp, Tilapia, Catfish, and Salmon
Method Performance vs SMPR criteria
Discussed in ERP meeting
Feedback Information Additional Recognition(s)
Yes No Yes Yes
10/2012; 12/2015
ERP Reports
Hurtaud-Pessel et al., J. AOAC Int . 96 , 1152(2013) Andersen et al., J. AOAC Int . 98 , 636(2015) Schneider & Andersen J. AOAC Int . 98 , 658(2015)
Manuscript(s) Published in JAOAC
ERP Method Recommendation (Final Action/Repeal/Continuation)
Final Action Method scope expanded and the latest version of the method approved by ERP is in Collaborative Study Manuscript published in 2015 by Schneider and Andersen.
April 2016
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