U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

IMS-a-33 - Charm II Sulfa Drug Test (competitive assay)
 
 
HHS;PHS;FDA;CFSAN;OFP;DCP;MSB
 
                                             200 'C' Street, SW
 
                                               Washington, D.C.
 
                                             September 12, 1995
 
                                                       IMS-a-33
 
 
 
To:        All Regional Food and Drug Directors
           Attn:  Regional Milk Specialists
 
From:      Milk Safety Branch, HFS-626
 
Subject:   Charm II Sulfa Drug Test (competitive assay)
 
The Charm II Sulfa Drug Test (competitive assay) has been evaluated by FDA
and was accepted by NCIMS at their  Board Meeting on July 29, 1995.  The
evaluation of this test demonstrated that it could detect Sulfamethazine,
Sulfadiazine, Sulfadimethoxine, and Sulfathiazole at or below the established
tolerances or safe levels for these drugs in milk.
 
Effective September 12, 1996, the Charm II Sulfa Drug Test (competitive assay)
will be the only screening/regulatory test acceptable for the detection of
Sulfamethazine, Sulfadiazine, Sulfadimethoxine, and Sulfathiazole.  If
additional tests are evaluated by FDA and accepted by the NCIMS for detection
of Sulfamethazine, Sulfadiazine, Sulfadimethoxine, and Sulfathiazole they will
also be acceptable as a screening/regulatory test.
 
This action was made possible by the passage of Proposal 241 at the 1995
NCIMS Conference and was done in accordance with Appendix N.
 
The acceptance of the evaluated test does not mandate any additional
screening by industry with the evaluated method.
 
Copies of this memorandum are enclosed for distribution to District Milk
Specialists, State Milk Regulatory Agencies, State Veterinary
Boards/Associations, State Laboratory Evaluation Officers and State Milk Rating
Officers in your region.  This memorandum is also available on the FDA Prime
Connection computer bulletin board system, and should be widely distributed to
representatives of the milk industry and other interested parties.
 
 
 
                            Joseph M. Smucker
                            Acting Chief, Milk Safety Branch, HFS-626
                            Division of Cooperative Programs
                            Center for Food Safety and Applied Nutrition
                            U.S. Food and Drug Administration