Inspections, Compliance, Enforcement, and Criminal Investigations
Home Acres Farm 27-Sep-06
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
September 27, 2006
Bill H. Nelson, Owner
Home Acres Farm
324 South Bailey-Hazen Road
East Ryegate, Vermont 05042
Dear Mr. Nelson:
An investigation of your dairy farm operation located at 324 South Bailey-Hazen Road, East Ryegate, Vermont, conducted by representatives of the U.S. Food and Drug Administration (FDA) on June 14, 2006, confirmed that you offered two animals for sale for slaughter as food that were adulterated within the meaning of 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 new animal drug, gentarnicin sulfate, to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 361 (a)(5)] of the Act 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 the links on the FDA web page at www.fda.gov.
On or about February 9, 2006, you offered for sale an adult dairy cow identified with backtag [redacted] and farm tag [redacted] for slaughter as food to [redacted]. On or about February 9, 2006, this animal was then sold and subsequently sold and transported to [redacted], where it was slaughtered for human food on February 10, 2006. United States Department of Agriculture, Food Safety and Inspection Service (USDAIFSIS) (Laboratory Report number 461117) analysis of tissue samples collected from that animal identified the presence of gentarnicin in kidney tissue.
On or about March 27, 2006, you offered for sale a second adult dairy cow identified with backtag # [redacted] ear tag # [redacted] ear tag and farm tag # [redacted] for slaughter as food to [redacted]. On or about March 27, 2006, this animal was then sold to [redacted] , transferred to [redacted], and subsequently sold and transported to [redacted], where it was slaughtered for human food on March 30, 2006. USDA/FSIS (Laboratory Report number 461354) analysis of tissue samples collected from that animal identified the presence of gentamicin in liver tissue and in kidney tissue. No tolerance has been established for residues of gentamicin in the edible tissues of cows as codified in Title 21, Code of Federal Regulations, Part 556.300 (21 C.F.R. 556.300). The presence of this drug in edible tissues from these animals 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)] of the Act.
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 complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Act.
In addition, you adulterated gentamicin sulfate solution 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. "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(ax5) of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of gentamicin sulfate solution failed to comply with these requirements. For example,your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 301(a)(5)] 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 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 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 the 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 sent to Ann Simoneau, Compliance Officer, U.S. Food and Drug Administration, One Main Street, 4th floor, Stoneham, MA 02108.
Gail T. Costello
New England District Office