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  5. Daniel Nickerson - 01/30/2015
  1. Compliance Actions and Activities

WARNING LETTER

Daniel Nickerson

Product:
Animal & Veterinary

Recipient:
Daniel Nickerson


United States

Issuing Office:
New York District Office

United States


   

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

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

 

 
January 30, 2015
 
 
WARNING LETTER NYK 2015-21 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE  REQUESTED
 
Mr. Daniel W. Nickerson, Owner
Daniel W. Nickerson Farm
4249 Danielson Road
Scio, New York 14880
 
Dear Mr. Nickerson:
 
On October 8 and 23, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4249 Danielson Road, Scio, New York 14880. 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 FDA's web page at www.fda.gov.
 
We found that you offered for sale three 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 May 19, 2014, you sold two bob veal calves, one identified with orange plastic ear tag (b)(4) and metal ear tag (b)(4), and the other identified with orange plastic ear tag (b)(4) and metal ear tag (b)(4), for slaughter as food.  On or about May 20, 2014, (b)(4), slaughtered these animals.  United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of 16.11 parts per million (ppm) of neomycin residue in the kidney for calf with ear tags (b)(4) and (b)(4) and 19.29 ppm of neomycin  for the second calf with ear tags (b)(4) and (b)(4).  In addition, our investigation also revealed that on or about June 2, 2014, you sold a third bob veal calf, identified with orange plastic ear tag (b)(4) and metal ear tag (b)(4), for slaughter as food.  On or about June 3, 2014, (b)(4), slaughtered this animal.  United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 16.8 ppm of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430).  However, this tolerance does not apply to the use of (b)(4)(neomycin sulfate and oxytetracycline hydrochloride), a medicated feed supplement, in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of this drug (neomycin) in calves intended for veal. The presence of this drug (neomycin) in edible tissue from these animals 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 neomycin sulfate and oxytetracycline hydrochloride found in (b)(4). Specifically, our investigation revealed that you did not use the medicated feed supplement as directed by its approved labeling. Use of (b)(4) in this manner is an extralabel use.  See 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 fed (b)(4)(neomycin sulfate and oxytetracycline hydrochloride), a medicated feed supplement, to a class of animals (veal calves with ear tags (b)(4) and (b)(4)(b)(4) and (b)(4), and (b)(4) and (b)(4) not set forth in its approved labeling and not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of (b)(4) resulted in illegal residues, in violation of 21 C.F.R. 530.11(c).  Because your use of the medicated feed supplement was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the medicated feed 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)(neomycin sulfate and oxytetracyclinehydrochloride), a medicated feed supplement, 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 supplement in conformance with its approved labeling.  Your use of this medicated feed supplement without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe within the meaning of 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.
 
We acknowledge a response was received from you on November 6, 2014.  However, this response is not adequate for the following reason: The drug treatment records reviewed during the inspection show that the firm's drug treatment records, even after corrective action was initiated, still lack complete information at times, in particular: the drug dosage administered, the route of administration, and the reason for treatment. Additionally, your response does not mention any plan to record this particular information in future drug treatment records.
 
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 Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A.Clark at (716) 846-6236 or e-mail at patrcia.clark@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District