Inspections, Compliance, Enforcement, and Criminal Investigations
Moreno Valley Dairy 16-Oct-07
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REOUESTED
October 16, 2007
Anthony Richard Van Ryn, Partner
Moreno Valley Dairy
34005 Gilman Springs Road
Moreno Valley, California 92555
Dear Mr. Van Ryn:
An investigation of your dairy operation located at 34005 Gilman Springs Road, Moreno Valley, California conducted by representatives of the U.S. Food and Drug Administration (FDA) on June 14, 2007, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). 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 February 13, 2007, you sold a culled dairy cow identified with Back Tag # 93GM1156 for slaughter as human food at [redacted] California. On or about February 13, 2007, this animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine at 5.36 parts per million (ppm) in the liver and at 4.38 ppm in the muscle. On or about December 1, 2006, you sold a culled dairy cow identified with Back Tag # 93GK7416 for slaughter as human food at [redacted]. On or about December 1, 2006, this animal was slaughtered at [redacted]. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine at 6.67 ppm in the liver and at 8.15 ppm in the muscle. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.640 (21.CFR 556.640). The presence of these drugs in these amounts in edible tissues from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for the 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. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Act.
The above is not intended to be an all-inclusive list of violations. We acknowledge that during the investigation you stated that you no longer employ the employee purportedly responsible for the tissue residue violation. However, as a producer of animals, which are offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute are 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 injunction and/or seizure.
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 receipt of this letter. Your response should include each step that has been 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 such corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
If you have any questions or need clarifications regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.
Your written response should be directed to:
Pamela B. Schweikert
Director, Compliance Branch
U.S. Food and Drug Administration
Irvine, California 92612
Alonza E. Cruse
cc: Asif Mann, Branch Chief
Ag Commodities & Regulatory Services Branch
California Department of Food & Agriculture
1220 North Street
Sacramento, California 95814-5607
Dr. Neal Westgerdes, D.V.M.
United States Department of Agriculture
Food Safety & Inspection Service
620 Central Avenue Building C
Alameda, California 94501