Inspections, Compliance, Enforcement, and Criminal Investigations
Bombay Dairy 01-Jul-04
Department of Health and Human Services
Public Health Service
Minneapolis District Office
July 1, 2004
WARNING LETTERCERTIFIED MAIL
|RETURN RECEIPT REQUESTED||
Refer to MIN 04 - 31
Richard M. Nystuen
45719 60th Avenue
Kenyon, Minnesota 55946
Dear Mr. Nystuen:
A tissue residue report received by the U.S. Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a dairy cow that originated from your dairy farm, Bombay Dairy, Kenyon, MN. On May 5, 2004, an investigator from the FDA conducted an inspection at Bombay Dairy. That inspection confirmed that you offered a dairy cow 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 (the Act). You also caused the adulteration of animal drugs because the drugs were used in a manner that does not conform to their approved uses or the extralabel use regulations at Title 21, Code of Federal Regulations, Part 530 (21 CFR 530, copy enclosed). This caused the animal drugs to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.
On or about March 3, 2004, you sold a dairy cow (identified with back tag number [redacted] for slaughter as human food. USDA analysis of tissue samples collected from this cow identified the presence of flunixin at 0.142 parts per million (ppm) in the liver. Flunixin is not approved for use in lactating or dry dairy cows (per 21 CFR 522.970, copy enclosed). The presence of flunixin in the edible tissue of this dairy cow causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act. Analysis of the tissue samples collected from this cow also identified the presence of penicillin at 0.16 ppm in the kidney. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle (21 CFR 556.510, copy enclosed). The presence of this drug, at a level above the tolerance, in edible tissue from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.
Our investigation also found that you hold animals under conditions that are inadequate to prevent animals bearing potentially harmful drug residues from entering the food supply. For example, you failed to maintain complete drug treatment records (records lacked dosage, route of administration, who administered the drug, and withdrawal times), and you failed to assure that medicated animals were withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs in edible tissues. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act.
The extralabel use of an approved veterinary or human drug is permitted only if it complies with Sections 512(a)(4) and (a)(S) of the Act and 21 CFR 530. Our investigation found that Bombay Dairy used penicillin and flunixin in an extralabel manner but failed to comply with these requirements. For example, penicillin was used in an extralabel manner (topical administration) without supervision of a licensed veterinarian. Approved uses of penicillin are specified in 21 CFR 522.1696b (copy enclosed). Flunixin was administered more frequently than specified in the prescription labeling, and pre-slaughter withdrawal time was not observed. 21 CFR 530.11(a) prohibits extralabel use by a lay person except when under the supervision of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship. In addition, 21 CFR 530.11(d) prohibits any extralabel use that results in a residue exceeding an established safe level, safe concentration or tolerance. Your use of flunixin and penicillin resulted in illegal drug residues. Because your extralabel use was not in compliance with 21 CFR 530, the drugs are unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501 (a)(5) of the Act.
It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for violations of the Act. Similarly, it is not necessary for you to personally ship an adulterated drug in interstate commerce. The fact that you caused the adulteration of animal drugs that had been shipped in interstate commerce is sufficient to hold you responsible.
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 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 occur. 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 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Also, include copies of any available documentation demonstrating that your corrections have been made.
Your reply should be directed to Compliance Officer Timothy G. Philips at the address indicated on the letterhead.
W. Charles Becoat
Enclosures: 21 CFR 530, 522.970, 522.1696b, 556.510
Michael W. Farrell
45719 60th Avenue
Kenyon, MN 55946