| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human Services
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 1000307183
WARNING LETTER
January 10, 2011
Mr. Earl John Vander Schaaf, Owner
Vander Schaaf Dairy #2
15355 Van Allen Road
Escalon, California 95320
Dear Mr. Vander Schaaf:
On September 22 and 27, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15355 Van Allen Road, Escalon, California 95320. 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 April 9, 2010, you sold a dairy cow, identified with ear tag (b)(4), for slaughter as food. On or about April 10, 2010, (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 sulfadimethoxine at 7.068 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). The presence of this drug in edible tissue from this animal 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 drugs sulfadimethoxine (b)(4) , sulfadimethoxine (b)(4), Penicillin G Procaine (b)(4) , and Ceftiofur (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine, penicillin G procaine, and ceftiofur as directed by its approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). In addition, the extralabel use of sulfadimethoxine is prohibited in lactating dairy cows under 21 C.F.R. 530.41(a)(9).
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 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 sulfadimethoxine (b)(4) to one of your dairy cows identified with ear tag (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Furthermore, your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 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).
Our investigation also found that you administer sulfadimethoxine (b)(4) to your dairy cows intravenously or subcutaneously whereas the label directions indicate the drug is to be administered intravenously only. Your extralabel use of sulfadimethoxine (b)(4) was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Sulfadimethoxine is prohibited for extra label use in lactating dairy cattle within 21 C.F.R. 530.41(a)(9). 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).
Our investigation also found that you administer penicillin G procaine injectable suspension (b)(4) to your dairy cows without following the dose as stated in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian which is in violation of 21 C.F.R. 530.11(a). 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).
Our investigation also found that you administer ceftiofur (b)(4) to your dairy cows without following the meat withdrawal period and conditions for treatment as stated in the approved labeling. Your extralabel use of ceftiofur was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). 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 Karen L. Robles, Compliance Officer, Food and Drug Administration, at 650 Capitol Mall Room 8-400, Sacramento, California 95814. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 114 or via e-mail at Karen.Robles@fda.hhs.gov.
Sincerely,
/s/
Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration
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