Inspections, Compliance, Enforcement, and Criminal Investigations
Hamlin Valley Farms, Inc. 29-Jan-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
January 29, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08 – 08
Mark Gullicksrud, President
Gary L. Gullicksrud, Vice President
Hamlin Valley Farms, Inc.
N49128 County Road V
Strum, Wisconsin 54770
Dear Messrs. Gullicksrud:
An inspection of your dairy operation located in Strum, Wisconsin, conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 21 and December 28, 2007, confirmed that you offered an animal 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 342(a)(4)]. The inspection also revealed that you caused the new animal drug ampicillin to become 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 can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov
On or about September 13, 2007, you consigned [redacted], a cattle trucker, to transport a dairy cow identified with your farm ear tag #4287 for slaughter as food. [redacted] applied back tag #35JS1906 to this cow, and delivered the cow to [redacted]. On or about September 13, 2007, 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 0.06 parts per million (ppm) ampicillin in kidney tissue.
A tolerance of 0.01 ppm has been established for residues of ampicillin in kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, section 556.40 (21 CFR § 556.40). The presence of this drug in excess of this amount in kidney 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 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 in your treatment records a reliable system to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. 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 ampicillin within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use this drug in conformance with the conditions for extralabel use prescribed by your veterinarian. “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 [21 U.S.C. §§ 360b(a)(4) and 360b(a)(5)], and 21 CFR Part 530. Our investigation found that your extralabel use of ampicillin failed to comply with these requirements.
For example, you administered ampicillin and failed to follow the slaughter withdrawal period of six days that was directed by your veterinarian’s extralabel prescription and you did so without supervision of a licensed veterinarian, in violation of 21 CFR § 530.11(a). Furthermore, your extralabel use of ampicillin resulted in an illegal drug residue, in violation of 21 CFR § 530.11(d). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)], and 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)].
Furthermore, on September 13, 2007, your firm provided [redacted] with a signed certification that stated that none of the animals your firm supplied to [redacted] on that date contained illegal levels of drug residues. Pursuant to section 301(h) of the Act [21 U.S.C. § 331(h)], providing such a false guaranty is prohibited.
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 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 of the steps you have taken to bring your firm into compliance with the law within 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 to prevent their recurrence. If corrective action cannot be completed within 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 written response should be sent to Elizabeth P. Mayer, Acting Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Ms. Mayer at (612) 758-7186.
W. Charles Becoat
Dr. Craig White
2810 Crossroads Drive, Suite 3500
Madison, WI 53718-7969
Dr. James Kile
Director, Policy Development Division
Landmark Center, Suite 300
1299 Farnam Street
Omaha, NE 68102