This release was revised
on January 5, 2009 to include changes to the fourth paragraph.
FOR IMMEDIATE RELEASE
January 2, 2009
Siobhan DeLancey, 301-796-4668
FDA Prevents Two Dairies from Adulterating Animal Drugs and Food
The U.S. Food and Drug Administration announced today that the District Court
for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies
and their owners, Douglas B. Handley and Irene Handley, from adulterating new
animal drugs and introducing adulterated food into commerce. Both companies
are based in Clovis, N.M.
FDA has cited the defendants on multiple occasions, most recently following
inspections of the dairies from June 24 to July 1, 2008. During these inspections
the FDA investigator noted that the defendants were not keeping adequate medication
records to prevent unsafe drug residues in cattle offered for slaughter, that
they failed to review treatment records prior to offering an animal for slaughter,
and that they were using medications for unapproved indications not specified
on the drug label. Although using drugs in this “extralabel” manner
is legal with a valid veterinarian-client-patient relationship, the defendants
did not have such a relationship.
FDA previously inspected Do-Rene Dairy on Feb. 1-5, 2005, and subsequently
sent the owners a Warning Letter summarizing the deviations, which were similar
to those found in the 2008 inspection. The letter informed the owners
that a failure to correct all violations may result in enforcement action,
including seizure or injunction.
In tissue samples collected since 2003, FDA determined that Do-Rene and Clover
Knolls Dairies offered 12 animals for slaughter with illegal drug residues.
The animals included dairy cows that tested positive for illegal levels of
the drugs flunixin, penicillin, neomycin and sulfadimethoxine, a drug expressly
prohibited from extra-label use in lactating cows. In addition, four
bob veal calves tested positive for sulfamethoxazole. (Bob veal calves are
calves less than 30 days old and may be as young as two days at slaughter.) These
residues may cause allergic reactions in extremely sensitive individuals, and
they may contribute to forming antibiotic-resistance in bacteria.
Under the terms of the consent decree, the defendants and their employees
cannot introduce any adulterated food into commerce, use animal drugs in an “extralabel” manner
without a valid veterinarian-client-patient relationship, or use drugs in animals
in which such drugs are expressly forbidden. Failure to obey the terms of the
consent decree could result in civil or criminal penalties.