Inspections, Compliance, Enforcement, and Criminal Investigations
Dutch Valley Farms 7/29/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Denver District Office|
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
July 29, 2010
Mr. Daniel Visser,
Dutch Valley Fanns
1271 State Road 288
Clovis, NM 88101
Ref. #: DEN-10-14
Dear Mr. Visser:
On June 22 - 24, 2010, the U.S. Food and Dmg Administration (FDA) conducted an investigation of your dairy operation located at 1271 State Road 288, Clovis, New Mexico. This letter notifies you of the violations of the Federal Food, Dmg, 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 an animal for sale 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 (b)(4) you sold a dairy cow, identified with ear tag (b)(4) for slaughter as food to (b)(4).The dairy cow was slaughtered by (b)(4) United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.333 pmis per million (ppm) Sulfadimethoxine in the liver tissue.
FDA has established a tolerance of 0.1 ppm for residues of Sulfadimethoxine in the edible tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.640, (21 C.F.R. 556.640). The presence of this drug in the edible tissues of this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Apt [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 Act [21 U.S.C. § 342(a)(4)].
We also found that you adulterated the new animal drug (b)(4) Sulfadimethoxine. Specifically, our investigation revealed that you did not use (b)(4) Sulfadimethoxine (b)(4) as directed by its 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. 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 also found that you administered (b)(4) Sulfadimethoxine (b)(4) to a dairy cow without following the dose as stated in the approved labeling. Specifically, you treated the cow with nearly double the recommended dose. You extralabel use of (b)(4) 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 (b)(4) Sulfadimethoxine resulted in an illegal 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 Act, [21 U.S.C. §360(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-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 foods you distribute are 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 injuntion.
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 frame within which the corrections will be completed. Please include copies of any available documentation that corrections have been made.
You written response should be sent to: William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, PO Box 25087, Denver, CO 80225-0087. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or email at firstname.lastname@example.org.
H. Thomas warwick
Denver District Director