Inspections, Compliance, Enforcement, and Criminal Investigations

Rusty Cattle Company 12/19/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

December 19, 2014
 

Ref: 2015-DAL-WL-08
 

WARNING LETTER

UPS OVERNIGHT MAIL

Ralph Dykeman, Jr, Owner
Rusty Cattle Company
13893 Highway 133
Paul's Valley, Oklahoma 73075
 

Dear Mr. Dykeman:

On August 27- 29, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle farm operation located at 13893 Highway 133, Paul's Valley, Oklahoma 73075. 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 May 28, 2014, you sold a cow, identified with back tag (b)(4), for slaughter as food. On or about May 29, 2014, the cow with back tag (b)(4) was slaughtered for food at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 1.123 parts per million (ppm) of penicillin and 1.23 parts per million (ppm) of desfuroylceftifur in the kidney tissue, and 1.56 parts per million (ppm) of flunixin in the liver tissue. FDA has established a tolerance level of 0.05 ppm of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510), a tolerance level of 0.4 ppm for residues of desfuroylceftifur in the kidney of cattle as codified in 21 C.F.R 556.113, and a tolerance level of 125 parts per billion for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286. The presence of these drugs in edible tissues from this animal in these amounts 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 maintain treatment records. 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).

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 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 Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Mr. Ta at 214-253-5217.
 

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 

cc:
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DVM
1100 Commerce Street, Room 516
Dallas, Texas 75242-0598

Oklahoma Department of Agriculture, Food & Forestry
Attn: Dr. Rod Hall, State Veterinarian
2800 North Lincoln Blvd.
Oklahoma City, OK 73105

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