| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human Services
April 23, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA, 10-19
Hendrik G. Doelman, Owner
Elma Dairy, LLC
7231 James Road Southwest
Rochester, Washington 98579
WARNING LETTER
Dear Mr. Doelman:
On March 10 and 12, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 144 North Bl9ckhouse Road, Elma, Washington. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the 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 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 September 21, 2009, you sold a dairy cow, identified with retain tag (b)(4) for slaughter as food, to (b)(4) On or about September 21, 2009, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur in the kidney at 1.04 parts per million (ppm) and sulfadimethoxine in the liver at 0.441 ppm. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.113 (21 C.F.R. 556.113) and 0.1 ppm sulfadimethoxine in the edible tissues of cattle, as codified in 21 C.F.R. 556.640. 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 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 complete treatment records and you failed to maintain adequate drug inventory system. 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).
We also found that you adulterated the new animal drugs ceftiofur hydrochloride (NADA 140-890) and sulfadimethoxine (NADA 031-715). Specifically, our investigation revealed that you did not use ceftiofur hydrochloride and sulfadimethoxine as directed by their approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including 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.
Our investigation found that you administered ceftiofur hydrochloride to a dairy cow without following the withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur hydrochloride was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use of ceftiofur hydrochloride resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Our investigation also found that you administered sulfadimethoxine to a dairy cow without following the conditions of use as stated in the approved labeling. Your extralabel use of sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you 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 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.
Our investigation also revealed that on or about February 10, 2009, you provided to (b)(4) a signed Cattle Feed and Drug Residue Affidavit certifying that, among other things, none of the cattle have an illegal level of drug residue. This signed affidavit covered the dairy cow identified with ear tag #(b)(4) (retain tag (b)(4) which was found to have violative residues of desfuroylceftiofur and sulfadimethoxine residue. Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. § 331(h). "You should take appropriate actions to ensure that this violation does not recur.
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 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, please contact Compliance Officer Lisa M. Althar at (425) 483-4940.
Sincerely,
/S/
Charles M. Breen
District Director
cc: Nicolaas H. Doelman, Dairy Manager
Elma Dairy, LLC
7231 James Road SW
Rochester, Washington 98579
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