Inspections, Compliance, Enforcement, and Criminal Investigations
Hill, Brian & Barbara 7/13/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
July 13, 2010
RETURN RECEIPT REQUESTED
Brian Hill, Owner
Brian & Barbara Hill
17416 Hinckley Road
Maple Park, Illinois 60151-5106
Dear Mr. Hill:
On March 24, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 17416 Hinckley Road, Maple Park, Illinois. This letter notifies you of the violations of the Federal Food, Drug, 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 for sale an animal 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 or about January 14, 2010, you sold a dairy cow identified by (b)(4) or slaughter as food. On or about January 15, 2010, (b)(5) 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 2.649 parts per million (ppm) of sulfamethazine residue in the liver tissue.
FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. 556.670). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the 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 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 sulfamethazine boluses for cattle. Specifically, our investigation revealed that you did not use sulfamethazine boluses as directed by its approved labeling. Use of this drug in this manner is an extralabel use per 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. 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 sulfamethazine boluses to the cow identified by (b)(4) without following the directions as stated on the approved labeling. Label directions for use of sulfamethazine boluses in cattle state "Do not use in female dairy cattle 20 months of age or older." Your extralabel use of sulfamethazine boluses was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a), and your extralabel use of sulfamethazine 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 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. 360b(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 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 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 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, 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 directed to Richard Harrison, Director, Compliance Branch, at the address of the letterhead. If you have any questions regarding this letter, please contact Mr. Richard Harrison at 312-596-4220 or via e-mail at RICHARD.HARRISON@FDA.HHS.GOV.
Scott J. MacIntire