Inspections, Compliance, Enforcement, and Criminal Investigations
Case Vlot Cattle 05-Feb-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Via Federal Express
Our Reference: 1000135013
February 5, 2002
Mr. Case B Vlot, Owner
Case Vlot Cattle
3197 Avenue 21
Chowchilla, CA 936 10
Dear Mr. Vlot:
A tissue residue report from the United States Department of Agriculture (USDA) and an
investigation of your firm on December 5 and 10, 2001, by Food and Drug Administration (FDA) Investigator Thomas W. Gordon have revealed serious violations of the Federal Food, Drug, and Cosmetic Act as follows:
A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal
drug that is unsafe within the meaning of Section 512. On August 31, 2001, you sold a
calf (identified by back tag 93 EU 2643 and USDA laboratory report number 394730) to
be slaughtered for human food. This calf was delivered for introduction into interstate
commerce by your firm and was adulterated by the presence of illegal drug residues.
USDA analysis of tissues from this calf revealed the presence of gentamicin in the kidney
at 9.08 ppm, and in the liver at 0.26 ppm. Presently, there is no tolerance for gentamicin
in the uncooked edible tissues of cattle. In addition, the USDA analysis found
sulfamethazine in the liver at 9.72 ppm; sulfadimethoxine in the muscle at 8.27 ppm; and
sulfadimethoxine in the liver at 13.64 ppm. The tolerance for sulfamethazine or
sulfadimethoxine in the uncooked edible tissues of cattle is 0.1 ppm.
A food is adulterated under Section 402(a)(4) of the Act "if it has been prepared, packed,
or held under insanitary conditions.. . whereby it may have been rendered injurious to
health. As it applies to this particular residue, "insanitary conditions" means that you
hold animals which are ultimately offered for sale for slaughter as food under conditions
which are so inadequate that medicated animals bearing possibly harmful drug residues are likely to enter the food supply.
You lack an adequate system for determining the medication status of animals you offer
for slaughter. You lack an adequate system for assuring that animals to which medication
is administered have been withheld from slaughter for appropriate periods of time to
deplete potentially hazardous residues of drugs.
You are frequently the individual who delivers, or offers for introduction into interstate
commerce, calves intended for slaughter for food. As such, you share responsibility for
violating the Federal Food, Drug, and Cosmetic Act if such animals are adulterated. To
avoid future illegal residue violations, you should take precautions such as:
1) implementing a system to identify the animals you purchase with records to
establish traceability to the source of the animal;
2) implementing a system to determine from the source of the animal whether the
animal has been medicated, and if so, with what drug(s); and
3), if the animal has been medicated, implementing a system to withhold the
animal from slaughter for an appropriate period of time to deplete potentially
hazardous residues of drugs from edible tissues. If you do not want to hold the
medicated animal, then it should be clearly identified and sold as a medicated
We request that you take prompt action to ensure that animals which you offer for sale as
human food will not be adulterated with drugs or contain illegal residues.
Introducing adulterated foods into interstate commerce is a violation of Section 301(a) of
You should be aware that it is not necessary for you to have personally shipped an
adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal for sale to another facility where it was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act.
This is not intended to be an all-inclusive list of violations. It is your responsibility to
ensure that all requirements of the Act are being met. Failure to achieve prompt
corrective action may result in enforcement action without further notice, including
seizure and/or injunction.
Within fifteen (15) days of the receipt of this letter, please notify our office in writing of
the specific steps you have taken to correct these violations and preclude their recurrence.
If corrective action cannot be completed within fifteen working days, state the reason for
the delay and the time frame within which corrections will be completed. Your response
should address each discrepancy brought to your attention during the inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Russell A. Campbell, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502.
Dennis K. Linsley