Inspections, Compliance, Enforcement, and Criminal Investigations
Excel Dairy, LLC 06-Apr-05
Department of Health and Human Services
Public Health Service
April 6, 2005
Return Receipt Requested
Alan D. Vander Horst, Co-Owner
Excel Dairy LLC
P.O. Box 267
Stephenville, Texas 76401
Dear Mr. Vander Horst:
On November 30 through December 2, 2004, an investigator from the U.S. Food and Drug Administration (FDA) -conducted an inspection at your dairy operation located at FM 219 South/Private Road 1381, Dublin, Texas. This inspection confirmed that you offered an animal for sale as food that was adulterated within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug which is unsafe within the meaning of Section 512(a) of the Act. You also caused the adulteration of a new animal drug per Section 501(a)(5) of the Act because the drug was used in a manner that does not conform with its approved use or extralabel use regulations, therefore making is unsafe within the meaning of Section 512 of the Act.
On or about September 8, 2004; you offered for sale an adult dairy cow identified with dairy ear tag number [redacted] ear tag [redacted] and [redacted] and back tag number [redacted] for slaughter for human food . This cow was sold, through intermediaries, to [redacted] USDA analysis (Laboratory Report number 450438) of tissue samples collected from that cow identified the presence of 0.51 parts per million (ppm) sulfadimethoxine in muscle tissue and 0.64 ppm of sulfadimethoxine in liver tissue . The tolerance for sulfadimethoxine is 0.1 ppm in the uncooked edible tissues of cattle (21 CFR Section 556.640).
You also caused the adulteration of the drug sulfadimethoxine within the meaning of Section 501(a)(5) of the Act when you failed to use the drug in conformance with its approved labeling or on the order of a licensed veterinarian. Your use of this drug without following the dosage level, duration of treatment, frequency of treatment, and withdrawal period of either the approved labeling or the order of your veterinarian causes this drug to be unsafe within the meaning of Section 512 of the Act. Extralabel drug use is permitted only in conformance with all criteria set forth in 21 CFR Part 530, including that there be no residue above established tolerance levels . Because your extralabel use of sulfadimethoxine resulted in the presence of a residue above the established tolerance, your use was not in compliance with the extralabel use regulations 21 CFR 530.11(d) . In addition, because your extralabel use of sutfadimethoxine was not on the lawful order of a licensed veterinarian, you also failed to comply with 21 CFR 530.10. You therefore caused the drug to be unsafe under Section 512(a) of the Act and thus adulterated within the meaning of Section 501(a)(5) of the Act.
A food is also adulterated under Section 402(a)(4) of the Act "if it has been prepared, packed, or held under insanitary conditions . . .whereby it may have been rendered injurious to health." As it applies in this case, "insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, our investigation found that you lack a system for assuring animals medicated on your farm have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drug residues from edible tissues. Foods from animals held under such conditions are adulterated under Section 402(a) (4) of the Act.
This is not an all-inclusive list of violations existing at your facility. As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the foods you distribute are in compliance with the law.
We note that this is not the first residue associated with farms under your management and control. In July 2004, our office sent you a warning letter for similar violations at Sierra Dairy, another dairy under your responsibility. You should evaluate your operations at this and other dairies under your control and take prompt action to correct 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.
It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
Please notify this office in writing within 15 working days of the steps you have taken to bring your farms into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence . If the corrective action cannot be completed within 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 reply should be directed to the Food and Drug Administration at the above letterhead address, to the attention of Sherrie L. Krolczyk, Recall and Emergency Coordinator.
Michael A Chappell
Dallas District Director