Inspections, Compliance, Enforcement, and Criminal Investigations
KZ Dairy 17-May-07
Department of Health and Human Services
Public Health Service
May 17, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-15
Robert C. Zieroth, Co-Owner
1224 State Route 6
Raymond, Washington 98577
Dear Mr. Zieroth:
An investigation that included an inspection of your dairy operation located at 1224 State Route 6, Raymond, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 7, 9, and 27, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under 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 21 U.S.C. § 342(a)(4), respectively]. The investigation also revealed that you caused the new animal drugs, sulfamethazine and lincomycin hydrochloride, to become unsafe under section 512 of the Act [21 U.S.C. § 360(b)] and thus adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about November 10, 2006, you offered for sale as human food a dairy cow identified by back tag #604. On or about November 13, 2006, this animal was slaughtered at [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 23.56 parts per million (ppm) of the drug sulfamethazine in the liver tissue and 48.27 ppm in the muscle tissue of the cow. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the uncooked edible tissues of cattle (see, Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. 556.670)). The presence of this drug in uncooked edible tissues from this animal in an amount that exceeds the established tolerance 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. This is because you lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records that include the date of treatment, the identity of the animal treated, the drug used on the animal, the dosage administered, the route of administration, and a withdrawal time for the treated animal. 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)].
In addition, our investigation found that you failed to use sulfamethazine and lincomycin hydrochloride in conformance with their approved labeling and approved applications. For example, you administered lincomycin hydrochloride to an animal species not listed on the approved labeling. Further, you administered sulfamethazine to a dairy cow, a class of animal not listed on the approved labeling. Our investigation also found that both of these drugs were expired. Using an expired new animal drug to treat your animals is an extralabel use because such use is other than in accordance with the drug's approved application, i.e., the expiration date of the drug is contained in the drug's approved application. Extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. § 360b(a)(4) and 21 U.S.C. § 360b(a)(5)] and 21 C.F.R. Part 530, which require that such extralabel 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 your extralabel use of sulfamethazine and lincomycin hydrochloride failed to comply with these requirements.
For example, your extralabel use of lincomycin hydrochloride was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Additionally, sulfamethazine is not approved for use in lactating cattle as specified in 21 C.F.R. 520.2260b(c)(2)(iii), and is prohibited for extralabel animal use in food-producing animals as provided by 21 C.F.R. 530.41(a)(9). Furthermore, your extralabel use resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of these drugs were not in compliance with 21 C.F.R. Part 530, your use caused the drugs 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 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 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, state the reason for the delay and the time 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 Lisa M. Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, you can contact Compliance Officer Lisa M. Althar at 425-483-4940.
Charles M. Breen
cc: Isabel Arrington, PhD, D.V.M.
Director, Technical Assistance/Correlation Staff
Department of Agriculture/Food Safety and Inspection Service
Technical Service Center
1299 Farnam Street
Omaha, NE 68102