Inspections, Compliance, Enforcement, and Criminal Investigations
Donald Pope Veal Farm 06-Jul-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
July 6, 2005
RETURN RECEIPT REQUESTED
Refer to MIN 05-16
Donald N. Pope
Donald Pope Veal Farm
10028 N. County Line Road
Whitewater, WI 53190
Dear Mr. Pope:
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 formula fed veal calf that originated from your farm in Whitewater, Wisconsin. On January 5, 6, and 18, 2005, an investigator from the FDA conducted an inspection of your veal operation. That inspection confirmed that you offered a veal calf for sale for slaughter as food that was adulterated under Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(C)(ii) and (a)(4). The inspection also revealed that you caused animal drugs 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). Finally, you caused an animal feed to be unsafe within the meaning of Section 512 of the Act, 21 U.S.C. 360b, and adulterated under Section 501(a)(6) of the Act, 21 U.S.C. 351(a)(6).
On November 9, 2004, you sold a formula fed veal calf (identified with retain tag 45501598) to be slaughtered for human food at [redacted]. USDA analysis of tissue samples collected from this calf identified the presence of neomycin in the kidney. Neomycin is not approved for use in veal calves, see 21 CFR 520.1484. The extralabel use of neomycin in veal calves, without complying with Section 512(a)(4) of the Act, 21 U.S.C. 360b(a)(4), and the extralabel use regulations in Title 21, Code of Federal Regulations (CFR), Part 530, causes the drug to be unsafe within the meaning of Section 512 of the Act, 21 U.S.C. 360b. The presence of this unsafe drug 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, 21 U.S.C. 342(a) (2) (C) (ii).
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 drug treatment records for the batch of veal calves that you sold to [redacted] on November 9, 2004. In addition, the drug treatment records that you keep do not document the condition for which the animal is being treated, the dosage administered, initials of the person administering the drug, and the withdrawal time for meat. 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).
Moreover, our investigation found that you did not use animal drugs,in conformance with the drugs' approved labeling. The extralabel use of an approved veterinary or human drug must comply with Sections 512(a)(4) and (a)(5) of the Act, 21 U.S.C. 360b(a)(4) and (a)(5), and 21 CFR Part 530 (copy enclosed). The extralabel use of an animal drug by a lay person is prohibited except when under the supervision of a licensed veterinarian within the context of a valid veterinarian client- patient relationship, see 21 CFR 530.11(a). The extralabel use of drugs in or on an animal feed is also prohibited, see 21 CFR 530.11(b). Our investigation revealed that you are routinely adding neomycin and chlortetracycline to milk replacer, which is an animal feed, to prevent scours and shipping fever in your veal calves. You are also adding sulfamethoxazole / trimethoprim to milk replacer to treat respiratory problems. These uses do not comply with Section 512(a)(4) of the Act and the extralabel use regulations, 21 CPR Part 530. Therefore, the drugs are 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). You also caused the adulteration of an animal feed under Section 501(a)(6) of the Act, 21 U.S.C. 351(a)(6).
Approved uses of neomycin and chlortetracycline are specified in 21 CFR 520.1484 and 21 CFR 520.445. Copies are enclosed. Sulfamethoxazole/trimethoprirn is approved for human use, but has no approved uses in animals.
It is not necessary for you personally to 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.
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 comply 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 15 working days of receiving this letter of the steps you have taken to bring your veal operation into compliance with the law. Your response should include each step being taken, or that will be taken to correct the violations and prevent their recurrence. 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 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