Inspections, Compliance, Enforcement, and Criminal Investigations
Hazenberg Dairy 10-Jun-08
Department of Health and Human Services
Public Health Service
June 10, 2009
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-20
Henry Hazenberg, Owner
5828 Champoeg Road NE
Saint Paul, Oregon 97137
Dear Mr. Hazenberg:
An inspection of your dairy operation located at 5828 Champoeg Road NE, Saint Paul, Oregon, conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 26 and 28, 2008 and April 3, 2008, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(2)(C)(ii) and21 U.S.C. § 342(a)(4)]. The inspection also revealed that you caused the new animal drug, penicillin, to become 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)]. 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 July 17, 2007, you sold five Holstein dairy cows, identified with the Hazenberg Dairy brand ; for slaughter as food to [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from one of those animals with sales tag number [redacted], identified the presence of penicillin at 0.71 parts per million (ppm) in the kidney tissue and 0.13 ppm in the liver tissue: A tolerance of 0.05 ppm has been established for residues-of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations Section 556.510 (21 C.F.R. 556.510).
On or about October 18, 2007, you sold eight Holstein dairy cows, identified with the Hazenberg Dairy brand, for slaughter as food to [redacted]. USDA/FSIS) analysis of-tissue samples collected from one of those animals with sales tag number [redacted] identified the presence of sulfadimethoxine at 2.36 ppm in the liver tissue and 0.76 ppm in the muscle tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in 21 C.F.R. 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) of the Act [(21 U.S.C. § 342(a)(2)(C)(ii)].
Our inspection 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, and you failed to systematically review treatment records prior to offering an animal for slaughter as human food to assure that appropriate withdrawa times have been observed. 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)].
In addition, you adulterated the new animal drug penicillin G procaine within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you, failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a 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) and 512(a)(5) of the Act [21 U.S.C. §§ 360b(a)(4) and 360b(a)(5)] and 21 C.F.R. Part 530. Our investigation found that your extralabel use of penicillin G procaine failed to comply with these requirements. For example, you administered the penicillin G procaine without following the withdrawal period 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) of the Act [21 U.S.C. 360b(a)] and your use caused it to be 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 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.
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 sent to Michael J. Donovan, 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 Mr. Michael Donovan at (425)483-4906.
Charles M. Breen
CC: FSIS District Office Western Region Attn: Regional Manager
620 Central Ave., Building 2B
Alameda, California 94501
Oregon State Department of Agriculture
Animal Health and Identification Division
635 Capital St. NE
Salem, OR 97301