March 2016 OMB Update: Page
6
of
6
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
50