Inspections, Compliance, Enforcement, and Criminal Investigations
Pal-Nel Farms 14-Apr-08
Department of Health and Human Services
Public Health Service
April 14, 2008
RETURN RECEIPT REQUESTED
Neil Chelton, Owner
Paul J. Chelton, Owner
Chad R. Keeler, Owner
44543 Erie County Line Road
Corry, Pennsylvania 16407
An investigation of your dairy operation located at 44543 Erie County Line Road, Corry, Pennsylvania, conducted by a representative of the U.S. Food and Drug Administration (FDA) on September 26, 2007, and October 17, 2007, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The investigation also revealed that you caused the new animal drug neomycin sulfate to become unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. §351(a)(5)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about April 18, 2007, you consigned two (2) bob veal calves, identified with sales/ear tag numbers [redacted] and [redacted], for slaughter as food at [redacted]. On or about April 19, 2007, these animals were slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal with sales/ear tag number [redacted] identified the presence of 272.43 parts per million (ppm) neomycin in the kidney tissue of this animal. USDA/FSIS analysis of tissue samples collected from the animal with sales/ear tag number [redacted] identified the presence of 134.44 ppm neomycin in the kidney tissue of this animal. A tolerance of 7.2 ppm has been established for rsidues of neomycin in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations, 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to use of neomycin oral solution in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with use of neomycin oral solution in veal calves (pre-ruminating calves). Therefore, the presence of this drug in the kidney tissue from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(c)(ii) of the 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records for your veal calves (pre-ruminating calves). Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
In addition, you adulterated [redacted] within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. §§ 360b(a)(4) & (a)(5)] and 21 C.F.R. Part 530. Our investigation found that your extralabel use of neomycin sulfate failed to comply with these requirements.
For example, you administered neomycin sulfate without following the approved animal class set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].
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 above violations and to establish procedures whereby such vio ations do not recur. Failure to do so may result in regulatory action without further n tice 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, 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 James C. Illuminati, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania, 19106. If you have any questions about this letter, please contact Compliance Officer, James C. Illuminati at 215-717-3078 or via e-mail at firstname.lastname@example.org.
Thomas D. Gardine
Enclosure: FDA-483 dated September 26, 2007
cc: Dr. John I. Enck, Director
PA Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 North Cameron Street
Harrisburg., PA 17120
Food Safety and Inspection Service (FSIS)
106 South 15th Street Suite 904
Omaha, Nebraska 68102
Attention: Residue Staff