Inspections, Compliance, Enforcement, and Criminal Investigations
Vander Horst Dairy and Farming
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204·3128
October 22, 2009
Return Receipt Requested
Mrs. Carole Vander Horst
Vander Horst Dairy and Farming
1162 Private Road 1209
Stephenville, Texas 76401-8473
Dear Mrs. Vander Horst:
On June 26 and 29, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 1162 Private Road 1209, Stephenville, Texas 76401-8473. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 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 Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the 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 March 12, 2009, you sold a dairy cow identified with ear tag # (b)(4) for slaughter. On March 12, 2009, (b)(4) slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this dairy cow with ear tag #(b)(4) identified the presence of 0.1 parts per million (ppm) of penicillin residue in the liver tissue. FDA has established a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm as codified in Title 21, Code of Federal Regulations, Section 556.510(a) [21 C.F.R. 556.510(a)]. The presence of this drug in edible tissue from this animal 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. 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 Act, 21 U.S.C. 342(a)(4).
We also found that you adulterated the new animal drug Penicillin (b)(4) (Injectable and/or Aqueous Suspension). Supecifically, our investigation revealed that you did not use Penicillin (b)(4) as directed by its approved labeling. Use of this drug 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 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 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 drug Penicillin (b)(4) to the dairy cow identified with ear tag# (b)(4) without following the dosage level as stated in the approved labeling. Your extralabel use of this drug was not under the supervision of a licensed veterinarian, in violation1 C.F.R. 530.11(a). Furthermore, your extralabel use of Penicillin (b)(4) resulted in an illegal residue, 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. Part 530, this drug was unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and your use caused the drug 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 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, 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 Sherrie L. Krolczyk, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Sherrie L. Krolczyk at 214-253-5312 or Sherrie.Krolczyk@fda.hhs.gov
Reynaldo R. Rodriguez, Jr.
Dallas District Director
cc: FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean
1100 Commerce Street, Room 516
Dallas, Texas 75242-0598