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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Belter John Jr dba Ethan Allen Farm 9/12/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781-587-7500
Fax 781-587-7556 

 

WARNING LETTER
CMS # 409629
 
VIA UPS Next Day Air
 
September 12, 2013
 
Mr. John H. Belter, Jr., Owner
Ethan Allen Farm
2 Country Club Drive
South Burlington, Vermont 05403
 
Dear Mr. Belter:
 
On June 26 and 28, and July 3 and 18, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at Ethan Allen Drive, South Burlington, Vermont. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov.
 
We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
 
Specifically, our investigation revealed that on or about the dates listed in the table below you sold two bob veal calves for slaughter as food that were subsequently slaughtered by (b)(4). As described in the table below, the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS), analysis of tissue samples collected from these two animals identified the presence of drugs in the edible tissues in which illegal residues were reported.
 

Sample Number
Date Sold
Slaughter Date
Identification
Animal Tissue
 
Residue
Residue Level
(ppm)
(b)(4)
09/10/2012
9/11/2012
 
Retain Tag
(b)(4)
 
Back Tag
(b)(4) 
Kidney
Neomycin*
9.81
(b)(4)
09/17/2012
09/18/2012
 
Retain Tag (b)(4)
 
Back Tags
(b)(4) 
Kidney
Gentamicin**
Detected

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
* FDA has established a tolerance of 7.2 parts per million (ppm) for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of (b)(4) Type B Medicated Feed containing oxytetracycline and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) Type B Medicated Feed containing oxytetracycline and neomycin in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).
 
** FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle. The presence of this 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 FD&C 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. 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) of the FD&C Act, 21 U.S.C. 342(a)(4).
 
We also found that you adulterated the new animal drugs oxytetracycline and neomycin that were contained in the (b)(4) Type B Medicated Feed, (b)(4) (lincomycin hydrochloride), (b)(4), and Gentamicin Sulfate Solution, (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling.  Use of these drugs in this manner is an extralabel use, as defined under 21 C.F.R. 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the 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 also found that you administered the new animal drugs oxytetracycline and neomycin that were contained in the (b)(4) Type B Medicated Feed to your bob veal calves without following the animal class as stated in the approved labeling. Your extralabel use of the new animal drugs oxytetracycline and neomycin that were contained in the (b)(4) Type B Medicated Feed was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs in the (b)(4) Type B Medicated Feed was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
 
In addition, the investigation found that you administered (b)(4) (lincomycin hydrochloride), (b)(4), as an intramammary infusion to your lactating dairy cows without following the directions for use as stated in the approved labeling. Your extralabel use of (b)(4) (lincomycin hydrochloride), (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
 
In addition, the investigation found that you administered Gentamicin Sulfate Solution, (b)(4), to your bob veal calf, identified with back tag (b)(4), without following your servicing veterinarian’s withhold condition for this drug in your cattle. Your extralabel use of Gentamicin Sulfate Solution, (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of this drug resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c).  Because your use of this drug was not in conformance with your servicing veterinarian’s order for the safe use of this drug in your cattle and did not comply with 21 C.F.R. Part 530, you caused the drug 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).
 
Furthermore, you adulterated the animal feed, (b)(4) Type B Medicated Feed containing oxytetracycline and neomycin, within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6), when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Section 512 of the FD&C Act, 21 U.S.C. 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feed.
 
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 violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
 
Our investigation also revealed that on or about March 13, 2005, you provided (b)(4), with a signed Livestock Owner’s Certificate stating that you were not delivering livestock to (b)(4), with an illegal level of drug residues. This signed certificate—which remains in full force and effect until revoked in writing by you and the revocation is delivered to (b)(4)—covered the bob veal calves that were sent to slaughter by you on or about September 10 and 17, 2012, and which were found to have illegal neomycin and gentamicin residues. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
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 corrective action cannot be completed within fifteen (15) working days of receiving this letter, 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 the Food and Drug Administration, Attention: Mr. Scott M. Loughan, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Compliance Officer Scott Loughan at 802-868-4725 x 109.
 
Sincerely,
/S/ 
Joseph S. Matrisciano
Acting District Director
New England District
 
 
cc:

Kristin Haas, D.V.M., Director
Division of Food Safety and Consumer Protection
Vermont Agency of Agriculture, Food and Markets
116 State Street
Montpelier, Vermont 05620
 
Susan Scarcia
Deputy District Manager
USDA Philadelphia, District 60
Mellon Independence Center
701 Market Street 2-B South
Philadelphia, Pennsylvania 19106
 
Kent E. Henderson, D.V.M.
President
Northwest Veterinary Associates
6 Fairfield Hill Road
St. Albans, Vermont 05478
 
 
Clarence C. Miller, Jr.
President
C.C. Miller Corporation
2013 Laporte Road
Morrisville, Vermont 05661