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.

March 2016 OMB Update: Page 6 of 6

April 2016

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