Diamond B Dairy 3/6/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
March 6, 2014
In reply refer to Warning Letter SEA 14-06
Kenneth A. Brandsma, Owner
Diamond B Dairy
3200 South 2169 East
Wendell, Idaho 83355-3536
Dear Mr. Brandsma:
On January 10, 16, and 17, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3200 South 2200 East, Wendell, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on 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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 July 25, 2013, you sold a cow, identified with ear tag 2310 and back tag (b)(4), for slaughter as food. On or about July 25, 2013, (b)(4), slaughtered this animal. 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 sulfamethazine at 24.73 parts per million (ppm) in the kidney. The FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21 C.F.R. 556.670). However, this tolerance does not apply to the use of Supra Sulfa III (sulfamethazine) Boluses, NADA 120-615, in female dairy cattle over 20 months of age (lactating dairy cows). The FDA has not established a tolerance for residues of sulfamethazine in the edible tissues of lactating dairy cows. As such, there is no acceptable level of sulfamethazine residue associated with the use of this drug in lactating dairy cows. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug Supra Sulfa III (sulfamethazine) Boluses, NADA 120-615. Specifically, our investigation revealed that you did not use Supra Sulfa III (sulfamethazine) Boluses, NADA 120-615, as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined under 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 Supra Sulfa III (sulfamethazine) Boluses, NADA 120-615, to a lactating dairy cow, identified with ear tag 2310 and back tag (b)(4), without following the approved label directions. The approved labeling for Supra Sulfa III (sulfamethazine) Boluses, NADA 120-615, states that this product is not to be used in dairy cattle 20 months of age or older. Sulfamethazine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9), and your use of Supra Sulfa III (sulfamethazine) Boluses, NADA 120-615, in a lactating dairy cow resulted in an illegal residue in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.
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 Maria P. Kelly-Doggett, Acting Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Maria Kelly-Doggett at 425-302-0424.
Ann M. Adams, Ph.D.
Acting District Director
cc: Idaho State Department of Agriculture
Division of Animal Industries
P.O Box 7249
Boise, Idaho 83707