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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Butternut Brook Farm 2/24/12

  

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, NY 11433 

 

                                               
February 24, 2012
 
WARNING LETTER NYK-2012-15
 
 
VIA UNITED PARCEL SERVICE
 
Robert M. Carpenter
Owner
Butternut Brook Farm
1074 28th Creek Road
Kennedy, New York 14747
 
Dear Mr. Carpenter:
 
On November 7 through 22, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1074 28th Creek Road,  Kennedy, New York 14747.  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 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 February 23, 2011, you sold three (3) bob veal calves, identified with ear tag numbers (b)(4) and (b)(4) for slaughter as food. On or about February 24, 2011, (b)(4), slaughtered these animals.  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
Ear Tag
Date Sold
Date Slaughtered
Amount of neomycin found in the kidney tissue (ppm)
Bob Veal Calf -Sample Number 574898
(b)(4)
02/23/11
02/24/11
19.99*
Bob Veal Calf - Sample Number 574900
(b)(4)
02/23/11
02/24/11
22.25*
Bob Veal Calf - Sample Number 574899
(b)(4)
02/23/11
02/24/11
31.14*

*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) - Medicated Supplement containing neomycin base (from 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) - Medicated Supplement containing neomycin base (from 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.  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 and oxytetracycline that were contained in the (b)(4) -Medicated Supplement.  Specifically, our investigation revealed that you did not use (b)(4) - Medicated Supplement containing neomycin base (from neomycin sulfate) and oxytetracycline as directed by its approved labeling.  Use of these drugs 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 administered the new animal drugs neomycin and oxytetracycline that were contained in the (b)(4) -Medicated Supplement to your bob veal calves without following the animal class as stated in its approved labeling.  Your extralabel use of the  new animal drugs neomycin and oxytetracycline that were contained in the (b)(4) - Medicated Supplement 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) - Medicated Supplement was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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 the medicated feed consisting of your cow’s milk mixed with (b)(4) - Medicated Supplement containing neomycin base (from neomycin sulfate) and oxytetracycline, 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 this 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 feeds.
 
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.
 
We are aware that you sold one bob veal calf, identified with ear tag number (b)(4), on or about December 29, 2010, that contained 12.48 ppm of neomycin in the kidney tissue.  FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle under 21 C.F.R. 556.430(b)(1).
 
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 Ms. Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433.  If you have any questions about this letter, please contact Compliance Officer Ms. Lillian C. Aveta at 718-662-5576 or by E-mail at lillian.aveta@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