Inspections, Compliance, Enforcement, and Criminal Investigations
Whitelyn Farms, Inc. 10-Sep-04
Department of Health and Human Services
Public Health Service
Baltimore District Office
September 10, 2004
Mr. Milton G. White, Jr., President
Whitelyn Farms, Inc.
5101 Hydes Road
Hydes, MD 21082-9563
Dear Mr. White:
A violative tissue residue report received by the United States Food and Drug Administration (FDA) from the United States Department of Agriculture* (USDA) reported the presence of illegal drug residues in a cow that originated from your farm. A subsequent investigation at your dairy operation located at Hydes, Maryland, conducted by our investigators on July 21 and August 4, 2004, confirmed that you offered an animal for sale for slaughter as food in violation of Sections 402(a)(Z)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (U.S.C.) Sections 342(a)(2)(C)(ii) and 342(a)(4), and that you may have caused animal drugs to become adulterated within the meaning of Section 501(a)(5), 21 U.S.C. § 351(a)(5)
A food is adulterated under section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug which is unsafe within the meaning of section 512. Moreover, a food is adulterated under Section 402(a)(4) of the Act if the food has been held under insanitary conditions whereby it may have been rendered injurious to health. In addition, a drug is adulterated under Section 501(a)(5) of the Act if it is a new animal drug which is unsafe within the meaning of Section 512 of the Act.
On or about April b, 2004, you sold a cow, identified with farm tag [redacted] for slaughter as human food at [redacted], USDA analysis of tissue samples collected from that animal identified the presence of 0.17 parts pe1-million (ppm) of Penicillin in the kidney tissue and 0.12 ppm of Penicillin in the liver tissue of the cow with farm tag [redacted]. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle (Title 21 Code of Federal Regulations 556.510(a)). The presence of this drug in edible tissue of this animal at a level exceeding the lawful tolerance level causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(u) of the Act.
Our investigation also found that you hold animals under conditions which are so inadequate that medicated animals bearing potentially harmful drugs residues are likely to enter the food supply. For example, you lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in the labeling, and for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. You medicated the animal with farm tag [redacted] with Procaine G penicillin on March 24, 28, 29, and 30, 2004, and then sold that same animal for slaughter for human food seven days later on April 6, 2004. That same animal was then slaughtered the following day on April 7, 2004. However, the label on the Procaine G Penicillin used to medicate the animal states that you must discontinue using the drug on cattle ten days before the animal was slaughtered for food. You therefore sold an animal for slaughter for human food prior to the expiration of the required ten day withdrawal period. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act.
In addition, you are adulterating the drug Procaine Penicillin G brand of penicillin that you firm uses on cattle within the meaning of Section 501(a)(5) of the Act when you fail to use the drug in conformance with its approved labeling. Your use of the drug without following the labeled withdrawal period causes the drug to be unsafe to use within the meaning of Section 512 of the Act.
The above 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 operations and the foods you distribute are in compliance with the law.
You should take prompt action to correct these deviations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction. Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence. Your response should outline the specific measures that you are taking to correct these deviations. You should include in your response documentation and written verification procedures or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your reply should be sent to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, Attention: Steven B. Barber, Compliance Officer. Mr. Barber can be reached at (410) 779-5134.
cc: Julie A. Cornett, D.V.M.
Branch Chief, Standards and Procedures
USDA/FSIS/Technical Services Center
Landmark Center, Suite 300
1299 Farnam Streei
Omaha, NE 68102