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IMS-a-36: Charm II Tetracycline Drug Test (Competitive Assay)

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HHS:PHS:FDA:CFSAN:OFP:DCP:MSB

200 C St., S.W.
Washington, DC 20204
IMS-a-36

January 17, 1997

TO: All Regional Food & Drug Directors
Attn: Regional Milk Specialists

FROM: Joseph M. Smucker, Chief Milk Safety Branch, HFS-626

SUBJECT: Charm II Tetracycline Drug Test (Competitive Assay)

The Charm II Tetracycline Drug Test (Competitive Assay) was evaluated by the Food and Drug Administration (FDA) and was accepted by the Executive Board of the National Conference on Interstate Milk Shipments (NCIMS) at their Board Meeting on December 23, 1996. The evaluation of the test demonstrated that it could detect Tetracycline, Chlortetracycline, and Oxytetracycline at or below the established safe levels for these drugs in milk.

Effective December 23, 1997, the Charm II Tetracycline Drug Test (Competitive Assay) will be the only screening/regulatory test acceptable for the detection of Tetracycline, Chlortetracycline, and Oxytetracycline. If additional tests are evaluated by FDA and accepted by the NCIMS for detection of Tetracycline, Chlortetracycline, and Oxytetracycline, they will also be acceptable as a screening/regulatory test.

This action was taken in response to Proposal 241 considered during the 1995 NCIMS and was taken in compliance with Appendix "N" of the current edition of the Grade A Pasteurized Milk Ordinance (PMO).

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 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, Chief
Milk Safety Branch
Center for Food Safety
and Applied Nutrition