Inspections, Compliance, Enforcement, and Criminal Investigations
Rogers Farm 26-Jul-07
Department of Health and Human Services
Public Health Service
New England District
One Montvale Avenue
Return Receipt Requested
July 26, 2007
William P. Rogers, Owner
2301 Southbridge Road
Warren, MA 01083
Dear Mr. Rogers:
An inspection of your dairy farm operation located at 2031 Southbridge Road, Warren, Massachusetts conducted by representatives of the U.S. Food and Drug Administration (FDA) on December 11 and 27, 2006, confirmed that you offered an animal for sale for slaughter as food that was 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, gentamicin sulfate, to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)) and unsafe under section 512 [21 U.S.C.§ 360b] of the Act. You also violated section 301(h) of the Act in that you provided a false guaranty [21 U.S.C. § 331(h)]. 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 or about August 9, 2006, you consigned one culled adult dairy cow, identified with Farm Tag #246 and Back Tag # 14EP0395, for slaughter as food through a [redacted] On or about August 9, 2006, the cow was sold at auction to [redacted] On or about August 11, 2006, the culled adult dairy cow was transported from [redacted] to [redacted], and was slaughtered for human food.
United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) analyses (USDA Case No. 06-0564-MA, Form No. 468260) of tissue samples collected from that animal identified the presence of gentamicin in the kidney tissue. No tolerance has been established for residues of gentamicin in the uncooked edible tissues of cattle. The presence of this drug in edible tissues from this animal 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 and review treatment records prior to offering an animal for slaughter for human food, to assure that appropriate withdrawal times have been observed. 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)] of the Act.
In addition, you adulterated gentamicin sulfate 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 extralable use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and Title 21, Code of Federal Regulations, Part 530 (21 C.F.R. 530). Our investigation found that your extralabel use of gentamicin sulfate failed to comply with these requirements.
For example, you administered the gentamicin sulfate in an animal class or species it is not approved for and you did so outside of the context of a valid veterinarian-client patient relationship in violation of 21 C.F.R. 530.10(a). Furthermore, your extralabel use resulted in a residue which may present a risk to public health, 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 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. § 351(a)(5)] of the Act.
On or about February 12, 2005, you provided [redacted] with a signed "Livestock Owner Certificate," which states that you will not supply [redacted] with any livestock that contain illegal levels of drug residues. On or about August 9, 2006, you had the culled adult dairy cow containing a residue of gentamicin sulfate delivered to [redacted] Pursuant to section 301(h) of the Act [21 U.S.C. § 331(h)], providing such a false guaranty is a prohibited 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 food you distribute is 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 violation and prevent its 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 copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Anthony P. Costello, Compliance Officer, One Montvale Avenue, Fourth Floor, Stoneham, MA 02180. If you have any questions you can contact Compliance Officer Anthony P. Costello at 781 596-7716.
Gail T. Costello
New England District Office