Inspections, Compliance, Enforcement, and Criminal Investigations
Toms, Matthew 20-Sep-07
Department of Health and Human Services
Public Health Service
September 20, 2007
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Matthew Toms, Owner
8500B Fountain Rock Road
Walkersville, Maryland 21793
Dear Mr. Toms:
An inspection of your dairy farm operation located at 8500B Fountain Rock Road, Walkersville; Maryland conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 20, 26 and 28, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated within the meaning of sections 402(a)(2)(c)(ii) 121 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 inspection also revealed that you caused the new animal drug, penicillin, to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act and unsafe under section 512 [21 U.S.C. 360b] of the Act. You can find the At and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about February 12, 2007, you consigned one culled adult dairy cow identified with Back Tag # [redacted] (Farm Tag # 10), for slaughter as food through a hauler to [redacted] trading as (T/A) [redacted] which is located at [redacted] Maryland.
On or about February 12, 2007, this cow was sold by [redacted] serves as the buyer for [redacted] Inc., which is located in [redacted]. On or about February 13, 2007, this cow was transported from [redacted] by [redacted] to [redacted] Inc., In [redacted]. On or about February 14, 2007, this cow was slaughtered for human food at [redacted] in [redacted].
United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of penicillin at 0.17 parts per million (ppm) in the kidney tissue (USDA Case No. 06-0453-MD, Form No. 503722). A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Part 556.510 (21 C.F.R. 556.510). The presence of this drug in this amount in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(c)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] of the Act.
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 are properly medicated by you. For example, you failed to maintain adequate treatment records to show the proper dosage level and number of days that an animal should be treated with a particular medication, and you failed to review those records prior to offering an animal for slaughter for human food. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4)[21 U.S.C. 342(a)(4)] of the Act.
In addition, you adulterated penicillin within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act 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) [21 U.S.C: 360b(a)(4)] and 512(a)(5) [21 U.S.C. 360b(a)(5)] of the Act and 21 C.F.R. 530. Our investigation found that your extralabel use of penicillin failed to comply with these requirements.
For example, you administered the penicillin without following the dosage level and duration of treatment 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 a residue above an established tolerance for this drug, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. 530, the drug was unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act, and your use caused it to be adulterated within the meaning of section 501 (a)(5) [21 U.S.C. 351(a)(5)] of the Act.
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 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, 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 Randy F. Pack, Compliance Officer, U.S. Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Randy F. Pack at (410) 779-5454, extension 417.
Isabel Arrington, Ph.D., D.V.M.
U.S. Department of Agriculture
Food Safety and Inspection Service
Technical Service Center
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Dr. Guy Hohenhaus, State Veterinarian
Maryland Department of Agriculture
Office of Marketing, Animal Industries and Consumer Services
50 Harry S. Truman Parkway
Annapolis, Maryland 21401