Inspections, Compliance, Enforcement, and Criminal Investigations
Pleasant View Farms, Inc. 29-Sep-05
Department of Health and Human Services
Public Health Service
September 29, 2005
RETURN RECEIPT REQUESTED
Rodney L. Metzer, President and Owner
Pleasant view Farms, Inc.
P.O. Box 124
Martinsburg, PA 166162
Dear Mr. Metzer:
An investigation of your dairy operation located at RD#1, Martinsburg, Pennsylvania conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 3 through May 6, 2005 confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a) (2) (C) (ii)] , and 402 (a) (4) [21 U.S.C. 342 (a) (4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The investigation also revealed that you have caused the new animal drugs, [redacted] and [redacted] to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov .
On or about February 14, 2005, you consigned a dairy cow identified with back tag [redacted] and ear tag [redacted] for slaughter at [redacted]. On or about February 15, 2005, this animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal identified the presence of [redacted] parts per million (ppm) [redacted] in the kidney tissue of the animal. A tolerance of [redacted] ppm has been established for residues of [redacted] in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), Part [redacted]. The presence of this drug in the edible tissues of this animal at the reported level causes the food to be adulterated within the meaning of section 402 (a) (2) (c) (ii) [21 U.S.C.342 (a) (2) (C) (ii)].
On or about October 18 2004, your consigned a calf identified with back tag [redacted] for slaughter at [redacted]. On or about October 19, 2004, this animal was slaughtered at [redacted]. USDA/FSIS analysis of tissue samples collected from the animal identified the presence of [redacted] parts per million (ppm) [redacted] in the kidney tissue. The tolerances for [redacted] are listed in Title 21, Code of Federal Regulations (21 CFR), Section [redacted]. The presence of [redacted] at the level reported in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402 (a) (2) (c) (ii) [21 U.S.C. 342(a)(2)(C)(ii)] because it contains a new animal drug that is unsafe within the meaning of section 512 of the Act. [21 U.S.C 360b].
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure 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. For example, you lack an adequate system for reviewing treatment records before offering an animal for slaughter to ensure that appropriate withdrawal times have been met and you failed to main treatment records for certain animals. Food from animals held under such conditions is adulterated within the meaning of section 402 (a) (4) of the Act [21 U.S.C. 342 (a) (4)].
In addition, you adulterate [redacted] and [redacted] within the meaning of section 501(a)(5) of the Act when you failed to use the drugs in conformance with their approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or,on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 CFR Part 530.
Our investigation found that your extralabel use of [redacted] and [redacted] failed to comply with these requirements. For example, you administered the [redacted] without following the withdrawal period and the [redacted] without adhering to the restriction on the approved animal class set forth in the approved labeling. You did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, the drugs were unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and your use caused them to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].
The above is not intended as an all inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
You should notify this office in writing, of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violation and prevent its recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the ,corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be sent to James C. Illuminati, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania, 19106. If you have any questions about this letter, please contact Compliance Officer, James C. Illuminati, at 215-717-3078 or via e-mail at jillumin@ora. fda.gov.
Thomas D. Gardine