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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Young View Farm 5/1/07

Department of Health and Human Service's Eagle LogoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
 New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

WARNING LETTER
NWE-18-07-W

VIA FEDERAL EXPRESS

May 1, 2007

Merle W. Young Jr., Owner
Young View Farm
118 County Road
West Glover, VT 05875

Dear Mr. Young:

An investigation that included an inspection of your dairy operation located at 118 County Road, West Glover, Vermont conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 24 and 25, 2007, confirmed that you offered animals for sale for slaughter as food that were 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 21 U.S.C § 342(a)(4), respectively]. The investigation also revealed that you caused the new animal drugs, neomycin sulfate and flunixin meglumine, to become unsafe under section 512 of the Act [21 U.S.C. § 360(b)] and thus 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's web page at www.fda.gov.

On or about November 30, 2006 you offered for sale as human food a dairy cow identified by back tag [redacted] farm tag [redacted] On or about December 1, 2006, this cow was slaughtered at [redacted] The United States Department of Agriculture, Food Safety and inspection service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.622 parts per million (ppm) of the drug flunixin in the liver tissue of the cow. A tolerance of 0.125 ppm has been established for residues of flunixin in the liver tissues of cattle (see Title 21, Code of Federal Regulations Section 556.286 (21 C.F.R.556.286). The presence of this drug in liver tissues from this animal in an amount that exceeds the established tolerance 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)].

On or about July 10, 2006, you offered for sale as human food a dairy cow identified with back tag [redacted] and farm tag [redacted] On or about July 11, 2006 this cow was slaughtered at [redacted] The USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 8.54 (ppm) of the drug neomycin in the kidney tissue of the cow. A tolerance of 7.2 ppm has been established for residues of neomycin in the uncooked edible tissues of cattle (see 21 C.F.R. 556.430). The presence of this drug in kidney tissues from this animal in an amount that exceeds the established tolerance causes the food to be adulterated within the meaning or 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 because 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 any treatment records. Your treatment records did not include the condition treated, the dosage administered, or a withdrawal time for the treated animal. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 C.F.R. §342(a)(4)].

In addition, our investigation found that you failed to use neomycin sulfate and flunixin meglumine in conformance with their approved labeling. For example, you administered neomycin sulfate for an intended use different than the one set forth in the approved labeling for cattle, and you administered flunixin for an intended use other than the approved use for cattle and you failed to follow the prescribed withdrawal time and route of administration. Such 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 21 U.S.C. § 360b(a)(5)] and 21 C.F.R. Part 530 which require that the extralabel use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Our investigation found that your extralable use of neomycin sulfate and flunixin meglumine failed to comply with these requirements.

For example, your extralabel use of neomycin sulfate and flunixin meglumine was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Furthermore, your extralable use resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your extralable use of these drugs were not in compliance with 21 C.F.R. Part 530, your use caused the 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).

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 these violations and prevent their recurrence. If corrective actions 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, 1 Montvale Avenue, Stoneham, MA 02180. If you have any questions about this letter you can contact Mr. Costello at 781-596-7716.

Sincerely,

/S/

Gail T. Costello
District Director
New England District Office

cc:
Julie A. Cornett D.V.M.
Senior Veterinary Officer
Technical Assistance/Correlation
USDA/FSIS
Technical Service Center
1299 Farnam Street
Omaha, NE 68102

David Lane
Acting Secretary
Agency of Agriculture
Food and Markets
116 State Street
Montpelier, VT 05620