Inspections, Compliance, Enforcement, and Criminal Investigations

River Valley Dairy 10/19/15

  

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 

 

October 19, 2015
 
 
WARNING LETTER NYK-2016-4
 
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Clarence Manor, Co-Owner
Mrs. Sandra Manor, Co-Owner
River Valley Dairy
6568 Military Turnpike
Ellenburg Center, New York 12934
 
Dear Mr. and Mrs. Manor:
 
On August 25, 2015 and September 2, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6568 Military Turnpike, Ellenburg Center, 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 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 June 9, 2015, you sold a bob veal calf, identified with (b)(4), for slaughter as food. On or about June 12, 2015, (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 neomycin at 16.34 parts per million (ppm)  in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of IBA Scour Treat 10g, (neomycin sulfate and oxytetracycline hydrochloride) in calves to be processed for veal (pre-ruminant calves), and there is no acceptable level of residue associated with the use of this drug in veal calves.  The presence of this drug in edible 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).
 
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 have a system in place to adequately segregate animals, you failed to maintain treatment records and you failed to adequately identify the animals that are transported and delivered for sale at an auction yard. 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 drug IBA Scour Treat 10g (neomycin sulfate and oxytetracycline hydrochloride). Specifically, our investigation revealed that you did not use IBA Scour Treat 10g as directed by the approved labeling. Use of the drug in this manner is an extralabel use. See 21 CFR 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 Act, 21 U.S.C. § 360b(a)(4) and (5) and 21 CFR 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 IBA Scour Treat 10g to a bob veal calf with (b)(4) without following the animal class as stated in the approved labeling. Your extralabel use of IBA Scour Treat 10g was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).   In addition, your extra-label use of IBA Scour Treat 10g was in or on feed, in violation of 21 C.F.R. 530.11(b) and resulted in and illegal 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 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, you adulterated IBA Scour Treat 10g 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 extra-label 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 are 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 CDR Frank Verni, 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 CDR Frank Verni, Compliance Officer at (718) 662-5702 or by email at frank.verni@fda.hhs.gov
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District

Page Last Updated: 10/26/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English