January 18, 2017
VIA UPS Overnight
Walter Vander Waal, Jr., Manager
Rolling View Farms, Inc. Dba Rolling View West
3718 Jefferson Ave.
Orange City, Iowa 51041
Ref: CMS 515002
Dear Mr. Waal:
On December 5-7, 2016, the Iowa Department of Agriculture and Land Stewardship (IDALS) conducted an investigation of your dairy operation located at 3718 Jefferson Avenue, Orange City, Iowa on behalf of the U.S. Food and Drug Administration (FDA). This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that IDALS found during the 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.
The investigation 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, the investigation revealed that on or about September 29, 2016, you sold a dairy cow, identified with ear tag white (b)(4) and back tag (b)(4), for slaughter as food. On or about September 29, 2016, (b)(4) located in (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 6.4 parts per million (ppm) of desfuroylceftiofur in the kidney tissue. FDA has established a tolerance of 0.4 ppm desfuroylceftiofur (marker residue for ceftiofur) in kidney tissue as codified in Title 21, Code of Federal Regulations (CFR), Section 556.113(b)(3)(i) (21 CFR 556.113(b)(3)(i)). The presence of this drug in edible tissues 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).
The IDALS investigation also found that you held 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 review said records to verify applicable withdrawal times prior to offering an animal for slaughter as food. 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).
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 Jessica Hensley, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact CO Hensley at (913) 495-5183 or via email at firstname.lastname@example.org.
Cheryl A. Bigham
Kansas City District
Walter Vander Waal, Owner
Rolling View Farms Inc.
Orange City, Iowa 51041
Randy Watts, Bureau Chief
Iowa Department of Agriculture and Land Stewardship (IDALS) Wallace Building
502 E. 9th Street
Des Moines, IA 50319