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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Superior Cattle Feeders LLC 09-Feb-04

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

Public Health Service
Food and Drug Administration

 

Los Angeles District
Pacific Region
19900 MacArthur Blvd.
Suite 300
Irvine, CA 92612-2445
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

W/L 26-04

February 9, 2004

Robert A. Lofton
Co-owner
Superior Cattle Feeders LLC
Post Office Box 1828
Calipatria, CA 92233

Dear Mr. Lofton:

Our records reflect you are one of the co-owners of Superior Cattle Feeders LLC located at 6050 Highway 111, Calipatria, CA. An investigation of your feedlot operation conducted by our investigator on December 10 and 11, 2003, confirmed that you offered animals for sale for slaughter as food which is in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (henceforth the ?Act?). The inspection also revealed that you caused animal drugs to become adulterated within the meaning of Section 501(a)(5) of the Act.

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 August 21, 2003, you sold a culled beef cow identified by USDA Laboratory report 256553 for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine in the liver at 00.11 parts per million (ppm) and in the muscle at 0.217 ppm. A tolerance of 0.10 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle (Title 21, Code of Federal Regulations(CFR), Section 556.640)].

Additionally, on or about August 21, 2003, you sold a culled beef cow identified by USDA Laboratory report 256554 for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of sulfamethazine in the liver at 52.33 ppm and in the muscle at 54.91 ppm. A tolerance of 0.10 ppm has been established for residues of sulfamethazine in the edible tissues of cattle (21 CFR 556.670)].

The presence of these drugs at the levels reported in the edible tissue of these animals causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

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. Foods from animals held under such conditions are considered adulterated under the Act.

It was further determined that you are using drugs in a manner contrary to their approved labeling as follows:

  • You are adulterating powdered sulfadimethoxine powder; such as [redacted] that you use on cattle in a manner contrary to the approved labeling. The labeled use is in the drinking water of animals. Your use as a top dressing of feed is not in agreement with the approved labeling.
  • You are adulterating injectable flunixin meglumine, such as [redacted] that you use on cattle in a manner contrary to the approved labeling. The labeled withdrawal time is 4 days. Your shipment of an animal after 3 days is not in agreement with the approved labeling.
  • You are adulterating injectable florfenicol, such as [redacted] that you use on cattle in a manner contrary to the approved labeling. The labeled withdrawal time is 28 days for intra-muscular injection and 38 for subcutaneous administration. Your shipment of an animal after 3 days is not in agreement with the approved labeling.
  • You are adulterating sulfamethazine boluses, such as [redacted] that you use on cattle in a manner contrary to the approved labeling. The labeled dose is 1 bolus per 200 pounds of animal weight. Your administration at 1 bolus per hundred pounds is not in agreement with the approved labeling.
  • You are adulterating injectable sulfadimethoxine, such as [redacted] that you use on cattle in a manner contrary to the approved labeling. The labeled instructions are 1 mL per 16 pounds of body weight the first day followed by 0.5 mL per 16 pounds of body weight every 24 hours thereafter. Your use of 15 mLs per 250 pounds for 3 consecutive days is not in agreement with the approved labeling.Such extra-label use is not permitted, except by or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship, and otherwise in compliance with the limitations set forth for specific extra-label uses. 21 CFR 530.10 and 530.11. Your use of drugs in any manner other than as labeled causes those drugs to be adulterated under Section 501(a)(5) of the Act because there is no approval for such use as required by Section 512(a)(1)(B) of 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 the violations.

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. Ifcorrective action cannot be completed 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:

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

Sincerely,

/s/

Alonza E. Cruse
District Director