Inspections, Compliance, Enforcement, and Criminal Investigations
Homen Dairy Farms, LP 27-Jun-05
Department of Health and Human Services
Public Health Service
San Francisco District
Via Federal Express
Our Reference: 1000123886
June 27, 2005
Jose M. Homen, Co-Owner
Durvalina Homen, Co-Owner
Homen Dairy Farms, LP
7496 Combs Road,
Merced, California 95340-9600
Dear Mr. and Mrs. Homen:
A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) reported the presence of illegal drug residues in a cow that originated from your dairy located at 5561 West Sandy Mush Road, Merced, CA. As a follow-up to USDA/FSIS's finding, our investigators performed an inspection of your dairy operation on March 14 and 17, 2005. This inspection confirmed that you offered an animal for sale for slaughter as food that was adulterated food within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Act [21 USC 342(a)(2)(C)(ii) and 342(a)(4)]. In addition, your extralabel usage of Bimeda brand Penicillin G Procaine and your extralabel use of Maxim-100 brand Oxytetracycline Hydrochloride caused these drug products to become adulterated within the meaning of Section 501(a)(5) of the Act [21 USC 351(a)(5)].
On January 20, 2005, you sold a dairy cow identified with ear tag number [redacted] subsequently identified with USDA/FSIS retain tag #47248888, for slaughter as human food. USDA/FSIS analysis of tissue samples (USDA/FSIS Sample #394836) collected from that animal identified the presence of the drug penicillin in the kidney at 0.155 parts per million (ppm), in the liver at 0.40 ppm, and in the muscle at 0.12 ppm. The tolerance level for penicillin in the uncooked edible tissues of cattle is 0.05 ppm (Title 21 Code of Federal Regulations (CFR), Part 556.510). The presence of penicillin above this level causes the food to be adulterated under Section 402(a)(2)(C)(ii) 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 which are so inadequate that medicated animals bearing possibly harmful drug residues are likely to enter the food supply. For example, our investigators noted the following:
You fail to maintain adequate medication treatment records for your dairy cows. For example, you utilize a daily calendar to record the ear tag number of cows confined to the hospital pen, but do not consistently indicate the reason for confinement nor the medication administered to the cows. Your records for treatments by infusion note the drug administered, but not the date of treatment and they are routinely discarded within a week of treatment.
You lack an adequate inventory/accountability system for determining the quantities of drugs used to medicate your livestock.
Introducing adulterated foods into interstate commerce is a violation of Section 301(a) of the Act [21 USC 331(a)]. You should be aware that it is not necessary for you to have personally shipped an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal for sale to a slaughter facility where it was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act. Causing the adulteration of drugs after receipt in interstate commerce is a violation of Section 301(k) of the Act [21 USC 331(k)].
You are also adulterating the drugs Bimeda brand Penicillin G Procaine and Maxim-100 brand Oxytetracycline Hydrochloride within the meaning of Section 501(a)(5) of the Act when you fail to use the drug in conformance with its approved labeling. The manufacturer's labeling of the Bimeda brand Penicillin G Procaine directs that no more than 10 ml be administered intramuscularly to any given injection site in livestock, and that the drug be administered at a rate of 3,000 units per pound of body weight (1 ml per 100 lbs). Your practice of administering one 40 ml (1,200,000 units) injection per day at a single injection site for lactating cows weighing approximately 1,500 pounds results in a dosage in excess of that allowed in the labeling. Similarly, the manufacturer's labeling of the Maxim-100 brand Oxytetracycline Hydrochloride indicates that it is for intravenous administration only, and that it is not for use on lactating dairy cattle. Your use of Maxim-100 brand Oxytetracycline Hydrochloride for infusing lactating dairy cattle is contrary to the approved labeling. The extralabel use of these drugs in dairy cattle may only be done in compliance with Sections 512(a)(4) and 512(a)(5) of the Act [21 USC 360b(a)(4) and 360b(a)(5)] and 21 CFR Part 530, Extralabel Drug Use in Animals. Our investigation found that your extralabel use of the drugs failed to comply with these requirements. For example, you administered Bimeda and Maxim-100 without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c).
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not occur. Failure to do so may result in regulatory action, such as a seizure and/or injunction, without further notice.
This is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that all requirements of the Act are being met.
You should notify our office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations and prevent their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Your response should address each discrepancy brought to your attention during the inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Warren E. Savary, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.
Barbara J. Cassens
San Francisco District