Inspections, Compliance, Enforcement, and Criminal Investigations
Legacy Dairy Farms LP 09-Oct-08
Department of Health and Human Services
Public Health Service
October 9, 2008
RETURN RECEIPT REQUESTED
Bradley D. Bouma, Senior Partner
Legacy Dairy Farms LP
1151 County Road AA
P.O. Box 1659
Plainview, Texas 79073-1659
Dear Mr. Bouma:
On June 19 and 20, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1151 County Road AA, Plainview, Texas. 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 the FDA's web page at www.fda.gov.
We found that you offered for sale animals for slaughter as food that were 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 7, 2008, you sold a dairy cow, identified with ear tag [(b)(4)] for slaughter as food. On or about March 7, 2008, [(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 oxytetracycline at 14.30 parts per million (ppm) in the kidney tissue and the presence of flunixin at 0.184 ppm in the liver. FDA. has established a tolerance of 12 ppm for residues of oxytetracycline in the kidney of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.500 (21 C.F.R. 556.500), and a tolerance 125 parts per billion (0.125 ppm) for residues of flunixin in the liver of cattle, as codified in 21 C.F.R. 556.286.
In addition, our investigation revealed that on or about March 14, 2008, you sold a dairy cow, identified with ear tag [(b)(4)] for slaughter as food. On or about March 14, 2008, [(b)(4)] slaughtered this animal. USDA/FSIS analysis of tissue samples collected from that same animal, identified the presence of flunixin at 3.427 ppm in the in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle, as codified in 21 C.F.R. 556.286.
The presence of oxytetracycline and flunixin in edible tissues from these animals in these amounts 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 oxytetracycline. Specifically, our investigation revealed that you did not use oxytetracycline 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 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 oxytetracycline to dairy cows without following the withdrawal period and animal class as stated in the approved labeling. Your extralabel use of oxytetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of oxytetracycline resulted in an illegal drug residue, In violation of 21 C.F.R. 530.11(d). Because your use of this drug, was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be 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).
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 with-in 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 Edwin Ramos, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204-3128. If you have any questions about this letter, please contact Compliance Officer Edwin Ramos at 214-253-5218.
Reynaldo R. Rodriguez, Jr.
Enclosure FDA-483 dated 6/20/08
cc: Veterinarian in-Charge
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102
Dr. Howard Johnson
State Director & Manager
Meat Safety Assurance Unit
Department of State Health Services
1100 West 49th Street
Austin, Texas 78756