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Attachment 3

ERP SUMMARY FOR FIRST TO FINAL ACTION METHOD RECOMMENDATION

GUIDANCE FOR AOAC ERPS - APPENDIX G

1

Considered?

Comments/Reference if applicable

Method Applicability

Yes

Triphenylmethane dyes as specified in

applicability statement.

ERP First to Final Action recommendations

& improvements implemented/addressed

Draft Final Action method reviewed by ERP

Safety Concerns

Yes

Completed and discussed during ERP meeting

ReferenceMaterials

Yes

Currently no reference materials available for

these types of drugs

Single Laboratory Validation

Yes

Hurtaud-Pessel et al.,

J. AOAC Int

.

96

, 1152(2013)

Andersen et al.,

J. AOAC Int

.

98

, 636(2015) H

modification H matrix extension

Reproducibility/Uncertaintyand

Probability of Detection

Yes

Schneider & Andersen

J. AOAC Int

.

98

, 658(2015)

Comparison to SMPR (

SMPR criteria metI)

Yes

SMPR 2009.001 H SMPR for Quantitative Methods

for Drug Residues in Shrimp, Tilapia, Catfish, and

Salmon; SMPR criteria met according to ERP

Feedback fromUsers of Method

Yes

Discussed in ERP Meeting

DOCUMENTATION

Available?

Comments

Safety Evaluation

Yes

Completed; Discussed in ERP meeting

ReferenceMaterials

No

None specified in SMPR; none available

SLV or PTMs

Yes

Hurtaud-Pessel et al.,

J. AOAC Int

.

96

, 1152(2013)

Andersen et al.,

J. AOAC Int

.

98

, 636(2015)

Approved Validation Protocols

No

Used SMPR; OMA appendix D, and help from

Chemical Contaminants Community subgroup

Statistics Review

Yes

Completed

Method Published in OMA

Yes

2012.25

Method Performance vs SMPR criteria

Yes

SMPR 2009.001 H SMPR for Quantitative

Methods for Drug Residues in Shrimp, Tilapia,

Catfish, and Salmon

Feedback Information

Yes

Discussed in ERP meeting

Additional Recognition(s)

No

ERP Reports

Yes

10/2012; 12/2015

Manuscript(s) Published in JAOAC

Yes

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)

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.

AOAC 2012.25

Residues of Three Triphenylmethane Dyes and Their Metabolites (Malachite

Green, Leuco Malachite Green, Crystal Violet, and Brilliant Green) in

Aquaculture Products

OMB Teleconference Materials

April 2016

34