Inspections, Compliance, Enforcement, and Criminal Investigations
Shady Ranch Dairy Inc 15-Oct-03
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
October 15, 2003
David Norris, President
Shady Ranch Dairy, Inc
19257 County Road 49
O'Brien, Florida 32071
Dear Mr. Norris:
An investigation of your dairy farm at the above address conducted by our investigators on July 10 and 16, 2003, confirmed that you offered an animal 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, and that you have caused animal drugs to become adulterated within the meaning of Section 501(a)(5).
On or about March 3, 2003 you sold a dairy cow, identified by back tag number 9548 (ear tag [redacted] and listed as USDA/FSIS Case # [redacted] for slaughter as human food by [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney tissue at 1.34 parts per million (ppm). A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle. See Title 21, Code of Federal Regulations (C.F.R.), Section 556.510. The presence of this drug at levels above the established tolerance in edible tissue from this animal causes the food to be adulterated.
The inspection of your firm found that the cause of the illegal tissue residue [penicillin 1.34 ppm in kidney] to be the result of extra-label use of injectable penicillin significantly beyond the dosage stated on the labeling. The extra-label use of an approved animal or human drug must meet certain conditions including the use of the drug by or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship [see 21 C.F.R. 530.10(a)]. Further, the extra-label use of a drug that results in any residue above an established safe level, safe concentration or tolerance is not permitted [see 21 C.F.R. 530.11(d)]. In this case, the drug was used contrary to label directions without a valid veterinarian client-patient relationship. Also, there is no indication your extra-label use of Penicillin G Procaine was authorized by your veterinarian, as the drug was administered by a lay person and no prescribing veterinary labeling information existed to assure safe and proper drug use. Moreover, the extra-label use of the drug resulted in a violation of the tolerance set for penicillin in the uncooked edible tissue of cattle. Therefore, the Penicillin G Procaine is adulterated under Section 501(a)(5) of the Act in that it is unsafe within the meaning of Section 512(a)(I)(A) of the Act.
This letter is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the food you distribute are in compliance with the law.
You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Federal Food, Drug, and Cosmetic Act. The fact that you caused the adulteration of an animal that was sold to a slaughter house that ship in interstate commerce is sufficient to hold you responsible for a violation of the Act.
You should notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent the recurrence of similar violations. If corrections cannot be completed within (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Also include copies of any available documentation demonstrating that corrections have been made.
Your reply relating to these concerns should be directed to the U.S. Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, you may contact Mr. Schroeder by telephone at (407) 475-4763.
Emma R. Singleton
Director, Florida District
cc: Mr. Larry S. Norris
Shady Ranch Dairy