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

Telephone: 510-337-6700

Via Federal Express

Our Reference: 1000135013

February 5, 2002

WARNING LETTER

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

animal.

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

the Act.

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.

Sincerely,

Dennis K. Linsley

District Director