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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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John Stewart Horton 11/14/12

  

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

Public Health Service
Food and Drug Administration
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433 

November 14, 2012
 

WARNING LETTER NYK-2013-6

VIA UNITED PARCEL SERVICE

John Stewart Horton, Owner
5493 Route 241
Conewango Valley, New York 14726
 

Dear Mr. Horton:

On August 20 and September 6, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5493 Route 241, Conewango Valley, New York. 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 five bob veal calves 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 the following:

  • On or about January 11, 2012, you sold a bob veal calf, identified with sale tag number (b)(4), for slaughter as food. On or about January 13, 2012, (b)(4), slaughtered this animal;
  • On or about March 14, 2012, you sold a bob veal calf, identified with sale tag number (b)(4), for slaughter as food. On or about March 16,2012, (b)(4), slaughtered this animal;
  • On or about March 21, 2012, you sold a bob veal calf, identified with sale tag number (b)(4), for slaughter as food. On or about March 23, 2012, (b)(4), slaughtered this animal; 
  • On or about March 28, 2012, you sold a bob veal calf, identified with sale tag number (b)(4) for slaughter as food. On or about March 30, 2012, (b)(4) slaughtered this animal; and,
  • On or about April 18, 2012, you sold a bob veal calf, identified with sale tag number slaughter as food. On or about April 19, 2012, (b)(4) slaughtered this animal.
     

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 animals identified the presence of neomycin in the uncooked edible tissues in which illegal residues were reported.
 

  

Animal
Sale Tag
Date Sold
Date Slaughtered
Amount of neomycin found in
the kidney tissue in parts per million (ppm)
Bob Veal Calf – Sample Number
(b)(5)
(b)(4)
January 11, 2012
January 13, 2012
50.28*
Bob Veal Calf – Sample Number
(b)(5)
(b)(4)
March 14, 2012
March 16, 2012
84.56*
Bob Veal Calf – Sample Number 
(b)(5)
(b)(4)
March 21, 2012
March 23, 2012
32.04*
Bob Veal Calf – Sample Number 
(b)(5)
(b)(4)
March 28, 2012
March 30, 2012
26.94*
Bob Veal Calf – Sample Number 
(b)(5)
(b)(4)
April 18, 2012
April 19, 2012
17.34*

 

*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) containing neomycin sulfate and oxytetracycline in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) containing neomycin sulfate and oxytetracycline in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from these animals in these amounts cause 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 treatment records and identify bob veal calves for sale as food. 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 drug (b)(4) (neomycin sulfate and oxytetracycline hydrochloride). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 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 found that you administered the (b)(4)  to your bob veal calves identified with sale tags (b)(4), without following the animal class as stated in the approved labeling. Your extralabel use of  (b)(4) was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extralabel use of (b)(4) 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 its approved labeling and did not comply with 21 C.F.R. Part 530, you caused this 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, you adulterated (b)(4) medicated feed 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.

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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. lf you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 846-6207 or E-mail at dean.rugnetta@fda.hhs.gov.
 

Sincerely,
/S/
Ronald M. Pace
District Director
New York District
 

cc:

Dr. David Smith, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235