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

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