• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Baarda Farms 6/5/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021
Telephone:      425-302-0340
FAX:    425-302-0402 

 

June 5, 2013
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply, please refer to Warning Letter SEA 13-22
 
Peter Baarda, Owner
Baarda Dairy
3895 Star Road
Meridian, Idaho 83646-5303
 
WARNING LETTER
 
Dear Mr. Baarda:
 
On January 14, 15, and 18, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3895 Star Road, Meridian, Idaho. 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 September 18, 2012, you sold a dairy cow, identified with ear tag (b)(4) and Brucellosis (Bangs) Vaccination tag (b)(4), for slaughter as food. On or about September 18, 2012, (b)(4), located in (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 detected the presence of tilmicosin, florfenicol, and enrofloxacin in the dairy cow, identified with ear tag (b)(4) and Brucellosis (Bangs) Vaccination tag (b)(4). Dentition records of this animal at the time of its slaughter identified the animal as being greater than 30 months of age. There is no tolerance for residues of tilmicosin, florfenicol, and enrofloxacin in the edible tissues of female dairy cattle greater than 20 months of age. The presence of these drugs 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 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:
  • Micotil 300 (tilmicosin) Injection, NADA 140-929;
  • Nuflor (florfenicol) Injectable Solution, NADA 141-063; and,
  • Baytril 100 (enrofloxacin) Injectable Solution, NADA 141-068.
 
Specifically, our investigation revealed that you did not use:
  • Micotil 300 (tilmicosin) Injection, NADA 140-929;
  • Nuflor (florfenicol) Injectable Solution, NADA 141-063; and,
  • Baytril 100 (enrofloxacin) Injectable Solution, NADA 141-068, as directed by their approved labeling and your servicing veterinarian’s written prescription.  Use of these drugs in this manner is an extralabel use as defined under Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (21 C.F.R. 530.3(a)).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C 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 the new animal drugs:
  • Micotil 300 (tilmicosin) Injection, NADA 140-929;
  • Nuflor (florfenicol) Injectable Solution, NADA 141-063; and
  • Baytril 100 (enrofloxacin) Injectable Solution, NADA 141-068, to your female dairy cattle greater than 20 months of age without following the animal class as stated in the approved labeling or prescribed by your servicing veterinarian.
 
Your extralabel use of the new animal drugs:
  • Micotil 300 (tilmicosin) Injection, NADA 140-929;
  • Nuflor (florfenicol) Injectable Solution, NADA 141-063; and
  • Baytril 100 (enrofloxacin) Injectable Solution, NADA 141-068, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and your servicing veterinarian’s written prescription and did not comply with 21 C.F.R. Part 530, you caused the drugs 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).  In accordance with 21 C.F.R. 522.812(e)(2)(iii), Baytril 100 (enrofloxacin) Injectable Solution, NADA 141-068, is not approved for use in female dairy cattle 20 months of age or older. Furthermore, in accordance with 21 C.F.R. 530.41(a)(10), Baytril 100 (enrofloxacin), a fluoroquinolone, is prohibited from extralabel use in food-producing animals.
 
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.
 
Our investigation also revealed that on or about April 26, 2010, you provided (b)(4), located in (b)(4), with a signed Ruminant Derived Protein / Drug Residue Certificate stating that you were not delivering livestock to (b)(4) with an illegal level of drug residues. This signed certificate—which remains in full force and effect until revoked in writing by you and the revocation is delivered to (b)(4)—covered the dairy cow that was sent to slaughter by you on or about September 18, 2012, and which was found to have an illegal tilmicosin residue. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
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 Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Jessica Kocian at the above address or by phone at 425-302-0444. 
 
                                                                          
Sincerely,
/S/ 
Charles M. Breen
District Director
 
 
cc:
 
Debra M. Lawrence, D.V.M.
Idaho State Department of Agriculture
Division of Animal Industries
P.O. Box 7249
Boise, Idaho 83707