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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Eagle Livestock Inc 15-May-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Los Angeles District
Irvine, CA 92612-2506
Telephone (949) 608-2900


 

 


WARNING LETTER

WL 22-06

CERTIFIED MAIL
RETURN RECEIPT REOUESTED


May 15, 2006

Rodger W. Camping
President
Eagle Livestock Inc.
P.O. Box 1178
Chino, CA 91710

Dear Mr. Camping:

Our records reflect you are one of the owners of Eagle Livestock Inc. located at 13456 Walker Ave., Ontario, CA. An investigation of your cattle growing operation conducted by our investigators on April 4-12, 2006, confirmed that you offered animals for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (henceforth the "Act") (codified at 21 U.S.C. §§ 342(a)(2)(C)(ii) and 342(a)(4)), and that you caused a new animal drug to become adulterated within the meaning of Section 501(a)(5) (21 U.S.C. § 351(a)(5).

A new animal drug is adulterated under Section 501(a)(5) of the Act if it is administered in a manner other than in accordance with the directions specified in the labeling, thereby making it unsafe within the meaning of Section 512(a)(1)(B) (21 U.S.C § 360b(a)(1)(B)). 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 of the Act. A food is further adulterated under Section 402(a)(4) of the Act if it has been held under conditions whereby it may have been rendered injurious to health.

On or about February 2, 2006, you sold a culled calf, identified by USDA Laboratory report 459033, for slaughter as human food. The USDA analysis of tissue samples collected from that animal identified the presence of gentamicin in the kidney, neomycin in the liver, flunixin in the liver at 0.365 ppm, sulfamethazine in the liver at 0.95 ppm and in the muscle at 0.57 ppm, and penicillin in the kidney at 1.99 ppm and in the liver at 0.35 ppm. There is no established tolerance for gentamicin in the edible tissue of cattle (21 CFR 556.300). The established tolerance for neomycin is 3.6 ppm in the liver of cattle (21 CFR 556.430); for flunixin the established tolerance
is 0.125 ppm in the liver of cattle (21 CFR 556.286); for sulfamethazine the established tolerance is 0.1 ppm in the edible tissue of cattle (21 CFR 556.670); and for penicillin the established tolerance is 0.05 ppm in the edible tissue of cattle (21 CFR 556.510).

Our investigation also found that you hold animals under improper conditions whereby diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack an adequate system for assuring that animals medicated by you have been withheld from slaughter for the appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues, and therefore you also lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in their labeling. Foods from animals held under such conditions are considered
adulterated under the Act, and the improper administration of animal drugs, including failure to withhold the medicated animal from slaughter as instructed in the labeling, cause the drugs to be adulterated under the Act.

The above is not intended to be an all-inclusive list of violations. As a producer of animals which are offered for use as food, you are responsible for assuring that your overall operations and the food you distribute are in compliance with the law.

Please note that it is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold to a slaughterhouse which ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

You should take prompt action to correct the above violations and to assure that the procedures you have established will prevent their recurrence. Failure to do so may result in regulatory action, such as injunction, without further notice. This letter constitutes official notification under the law and provides you an opportunity to correct.

Please advise this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your dairy into compliance with the law. Your response should include each step that has been taken to correct the violations and prevent their recurrence. If corrective action cannot be taken within fifteen (15) working days, state the reason for the delay and the time within which such corrections will be made. If you have any questions or need clarifications regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.

Your written response should be directed to:

Pamela B. Schweikert
Director, Compliance Branch
U.S . Food and Drug Administration
19701 Fairchild
Irvine, CA 92612

Sincerely,

/S/

Alonza E. Cruise
District Director