Inspections, Compliance, Enforcement, and Criminal Investigations
Moisan Dairy 13-Dec-07
Department of Health and Human Services
Public Health Service
December 13, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-04
Donald J. Moisan, Owner
9165 Wheatland Road
Salem, Oregon 97303
Dear Mr. Moisan:
An investigation of your dairy operation, conducted by a representative of the U.S. Food and Drug Administration (FDA) on August 22-23, 2007, confirmed that you offered an animal for sale for slaughter as food that was 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). The investigation also revealed that you caused the new animal drug penicillin to become unsafe within the meaning of section 512 [21 U.S.C. § 360b] of the Act and thus adulterated under section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You also violated section 301(h) [21 U .S.C. § 331(h)] of the Act in that you provided a false guaranty . 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 March 8, 2007, you consined a dairy cow, identified with Ear Tag number [redacted] and Back Tag [redacted] (listed as [redacted] the report from the United States Department of Agriculture, Food Safety, and Inspection Service USDA/FSIS Residue Violation Information System) for slaughter as food to [redacted]. The animal was subsequently sold to [redacted] where it was slaughtered for food on March 9, 2007. United States Department of Agriculture, Food Safety, and Inspection Service (USDA/FSIS) analyses of tissue samples collected from that animal identified the presence of sulfadimethoxine in both the liver at 7.27 parts per million (ppm) and the muscle at 1.60 ppm of the cow. Analyses of tissue samples collected from that animal also identified the presence of penicillin in the kidney at 2.22 ppm.
A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.640(b)(1) [21 C.F.R. 556.640(b)(1)] and a tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 C.F.R. 556.510(a). The presence of these drugs in uncooked edible tissues from this animal in amounts exceeding the established tolerances 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 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 that include the name of the individual who administered the drug, the dosage administered, the route of administration, the required withdrawal time, and the date the animal may be offered for slaughter for human food. 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.
In addition, you adulterated the penicillin within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of the drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of penicillin failed to comply with these requirements.
For example, you administered the penicillin without following the dosage level set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.
Furthermore, on March 8, 2007, your firm provided [redacted] with a signed certification which stated that none of the animals your firm supplied to [redacted] on that date contained illegal levels of drug residues. Pursuant to section 301(h) [21 U.S.C. § 331(h)] of the Act, providing such a false guaranty is prohibited.
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 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 seizure and/or injunction.
In addition, we are aware that USDA/FSIS notified your firm by letter dated October 11, 2007, via Certified U.S. Mail, that analyses (USDA Case No. 07-0327-OR, Form No. 474271) of tissue samples collected from a dairy cow sold by your dairy farm, identified with retain tag number 47308762 and slaughtered on September 7, 2007, identified the presence of sulfadimethoxine in the liver at 0.12 ppm and of sulfamethazine in the liver at 0.15 ppm.
We also remind you that the extralabel use of sulfonamide drugs in lactating dairy cattle is prohibited by 21 C.F.R. 530.41(a)(9). At least two dairy cows attributed to your operation have been found to have violative levels of sulfadimethoxine. You should carefully review your use of sulfonamide drugs. You may only use sulfonamide drugs in lactating dairy cattle that are approved for use in lactating dairy cattle. Further, these drugs must be used in accordance with the directions for use on the drugs' labels, including the length of treatment. Because extralabel use of these drugs in lactating dairy cattle is prohibited, any deviation from the label directions for use would adulterate the drug under section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.
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 demonstrating that corrections have been made. Please also include a description of why the most recent residues noted by USDA/FSIS in its October 11, 2007, letter occurred, and what you are doing to ensure future compliance.
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.
Charles M. Breen
cc: United States Department of Agriculture
Food Safety and Inspection Service
665 South Broadway
Boulder, Colorado 80303
Dr. Donald E. Hansen, State Veterinarian
Oregon Department of Agriculture
Animal Health and Identification Division
Animal Health Program
635 Capitol St. NE
Salem, Oregon 97301-2532