200 C Street, SW
September 12, 1995
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