Inspections, Compliance, Enforcement, and Criminal Investigations
Par 5 Dairy 02-May-07
Department of Health and Human Services
Public Health Service
Denver District Office
May 02, 2007
RETURN RECEIPT REQUESTED
Mr. Mitchell K. Visser
Par 5 Dairy
6839 Old Chisum Trail
Dexter, NM 88230
Ref. #: DEN-07-04
Dear Mr. Visser:
A tissue residue report received by the U.S. Food and Drug Administration (FDA) from the United States Department of Agriculture/Food Safety Inspection Service (USDA/FSIS) reported the presence of an illegal drug residue in a cow owned by your firm. As a follow-up to the USDA's findings, an FDA investigator conducted an inspection of your dairy operation located at 6839 Old Chisum Trail, Dexter, New Mexico, on February 13-14, 2007. The inspection confirmed that you offered an animal for sale, for slaughter as food that was 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 the drug Sulfadimethoxine to become adulterated within the meaning of section 501(a)(5) of the Act [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 October 10, 2006, you sold a dairy cow, identified with ear tag [redacted] for slaughter as food to [redacted]. This animal was slaughtered by [redacted] on October 10, 2006. USDA/FSIS analysis of tissue sample [redacted] collected from this animal, identified the presence of 14.00 ppm Sulfadimethoxine in the liver and 11.34 ppm Sulfadimethoxine in the muscle.
A tolerance of 0.1 ppm has been established for residues of Sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21 Code of Federal Regulations, section 556.640 (21 CFR 556.640). During our investigation, you stated you treated this animal [redacted] with [redacted] (sulfadimethoxine [redacted]). The presence of this drug in the edible tissues of this animals in amounts exceeding the tolerance set out in the 21 CFR 556.640 causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [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 drug from edible tissues. For example, you failed to maintain animal treatment records and failed to systematically review treatment records prior to offering an animal for slaughter for human food to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed.
In addition, you adulterated the drug Sulfadimethoxine when you failed to use the drug in conformance with its 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 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 Sulfadimethoxine failed to comply with these requirements. For example, you administered the Sulfadimethoxine without following the dosage level and withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512 of the Act [21 U.S.C. § 360b] and thus, your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351 (a)(5)].
You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale, through a broker or auction, to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
This 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 foods you distribute are 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, such as seizure and/or injunction.
You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the steps you have taken to correct these violations and preclude 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 with your response copies of any documentation demonstrating that corrections have been made. Your response should be sent to Nancy G. Schmidt, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.
B. Belinda Collins
Mr. Robert K. Jones, D.V.M
Boulder District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
I. Miley Gonzalez, Ph.D.
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, New Mexico 88003-8005