Inspections, Compliance, Enforcement, and Criminal Investigations
G & G Dairy 10-Aug-05
Department of Health and Human Services
Public Health Service
August 10, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-29
Mike D. Griffith, Partner
G & G Dairy
2627 Morning Sun Drive
Twin Falls, ID 83301
Dear Mr. Griffith:
On May 12-13, 2005, our investigator inspected your dairy farm located at 328 South 300 East, Jerome, Idaho. This inspection confirmed that you offered an animal for sale for slaughter as food in violation of sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(2)(C)(ii) and 342(a)(4)], and you caused a new animal 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)].
A food is adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)] if it contains a new animal drug that is unsafe within the meaning of section 512(a) of the Act [21 U.S.C. 360b(a)]. You sold a dairy cow on February 22, 2005, identified with back tag # [redacted] and USDA Case # 8-0312-05, and further identified as USDA-FSIS lab report # 455948, for slaughter as human food to [redacted]. USDA analysis-of tissue samples collected from that animal identified the presence of penicillin in the kidney at 1.22 parts per million (ppm) and in the muscle at 0.42 ppm. The tolerance for penicillin in edible tissues of dairy cattle is 0.05 ppm (Title 21, Code of Federal Regulations, section 556.510). The presence of this drug inedible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. 342(a)(2)(C)(ii)].
A food is adulterated under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] "if it has been prepared, packed, or held under insanitary conditions . . .whereby it may have been rendered injurious to health." Our investigation found 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:
1. You lack an adequate system for assuring that the medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.
2. You lack adequate written treatment records for animal drugs administered to your herd. You could not produce treatment records for the dairy cow identified above and the treatment records that you do maintain lack the dosage administered, the route of administration, the identity of the person administering the drug, and withdrawal times.
3. You lack an adequate inventory system for determining the quantities of drugs used to medicate your livestock.
You also caused the drug Penicillin G Procaine to become adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)) when you failed to use the drug in conformance with the approved labeling. The use of a drug in an animal in a manner that is not in accordance with the approved labeling is only permitted if it is in compliance with sections 512(a)(4) and 512(a)(5) of the Act and 21 CFR Part 530, including the requirement 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. You used this drug without the oversight of a veterinarian causing 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. You should take prompt action to correct the above 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. You should also be aware that it is not necessary for you to have personally shipped an animal into interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale, through a broker or auction, to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for violations of the Act.
Within fifteen (15) days of the receipt of this letter, please advise this office of the specific steps you have taken to correct these violations and preclude 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. Please include with your response copies of any documentation demonstrating that corrections have been made.
Please send your written reply to the Food and Drag Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Althar at (425) 483-4940.
Charles M. Breen