Inspections, Compliance, Enforcement, and Criminal Investigations
MPM Farms 17-Aug-06
Department of Health and Human Services
Public Health Service
Kansas City District
August 17, 2006
RETURN RECEIPT REQUESTED
Ref. KAN 2006-18
Kent W. Pulfer, DVM
811 Brooke Drive
Wayne, NE 68787
Dear Dr. Pulfer:
An investigation of your dairy operation located at 85556 572nd Avenue, Wayne, Nebraska, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 12 & 14, 2006, 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 inspection also revealed that you caused Quartermaster® Dry Cow Treatment brand of penicillin and dihydrostreptomycin to become 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 FDA's web page at www.fda.gov.
On or about February 13, 2006, you sent a cow identified with eartag #3066 for slaughter as food to [redacted]. On or about February 13, 2006, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 1.91 parts-per-million (ppm) ampicillin in the kidney tissue of the animal. A tolerance of .O1 ppm has been established for residues of ampicillin in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations Section 556.40 (21 C.F.R. 556 .40). The presence of this drug in the kidney tissue from this animal in this amount 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 March 14, 2006, you sent a cow identified with eartag #3066 for slaughter as food to [redacted]. On or about March 15, 2006, this animal, was slaughtered at [redacted]. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 6.63 ppm dihydrostreptomycin in the kidney tissue of the animal. A tolerance of 2.0 ppm has been established for residues of dihydrostreptomycin in the kidney tissues of cattle as codified in 21 C.F.R. 556.200. The presence of this drug in the kidney tissue of this animal in this amount 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)].
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 failed to maintain treatment records for standard drug treatments administered to animals owned by your firm. 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 adulterated Quartermaster's Dry Cow Treatment brand of penicillin and dihydrostreptomycin within the meaning of section 501(a)(5) [21 U.S.C.§ 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and (5) [21 U.S.C. §§ 360b(a)(4) and (5)] of the Act and 21 C.F .R. Part 530. Our investigation found that your extralabel use of the aforementioned drugs did not comply with these requirements.
For example, you administered these drugs without following the withdrawal period set forth in the approved labeling. Your failure to comply with the withdrawal period resulted in an illegal drug residue. Because your use of this drug was not in compliance with the approved labeling or 21 C.F.R. Part 530, your use caused the drug to be unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].
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 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 establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as 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 violations and prevent their 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 directed to Nadine Nanko Johnson, Compliance Officer, at the above address.
John W. Thorsky
Kansas City District