Department of Health and Human Services
June 12, 2012
WARNING LETTER NYK-2012-21
VIA UNITED PARCEL SERVICE
Edgar, Jan, and Jeffrey King, Co-Owners
King Ransom Farm LLC
311 King Road
Northumberland, New York 12871-2013
Dear Messrs. King:
On April 11-13, 17, and 20, 2012, the U.S. Food
and Drug Administration (FDA) conducted an investigation of your dairy and bull
breeding operation located at 311 King Road, Northumberland, 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 an animal for slaughter as food that was
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 December 29,
2011, you sold a bob veal calf, identified with the sale tag
(b)(4), for slaughter as food. On or about December 30, 2011,
(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 15.83 parts per
million (ppm) of neomycin in the kidney tissue. 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.), Section
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)
in bob veal calves (pre-ruminating calves), and there is no acceptable level of
residue associated with the use of this drug in bob veal calves (pre-ruminating
calves). The presence of this drug in kidney tissue from this animal in these
amounts 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 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 calf identified with sale tag (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 CFR 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 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, 300 Pearl Street, Suite 100,
Buffalo, New York 14202. If you have any questions about this letter, please
contact Compliance Officer Dean Rugnetta at (716) 541-0324 or E-mail at
dean.rugnetta@fda.hhs.gov,
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
cc:
Dr. John P. Huntley, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235