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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nelson, Douglas Jr. 09-Nov-06

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

Public Health Service
Food and Drug Administration

 

One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896


 



WARNING LETTER
NWE-05-07W

VIA FEDERAL EXPRESS

November 9, 2006

Douglas Nelson Jr., Owner
808 Derby Road
Derby, Vermont 05829-9796

Dear Mr. Nelson:

An inspection of your cattle operation located at Black River Road, Craftsbury, Vermont conducted by representatives of the U.S. Food and Drug Administration (FDA) on June 13 and August 6, 2006 confirmed that you offered animals for sale for slaughter as food that were adulterated under section 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 inspection also revealed that you caused the new animal drug Penicillin G Procaine to become unsafe under Section 512(a)[21 U.S.C.§ 360b) and adulterated within the meaning of Section 501(a)(5)[21 U.S.C. § 351(a)(5)] of the Act. 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 January 5, 2006 you offered for sale as human food a dairy cow identified with Back Tag [redacted] and Ear Tag [redacted]. This cow was picked up by a cattle dealer [redacted]. The cow was sold the same day to [redacted] where it was slaughtered on, January 6, 2006.The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.45 parts per million (ppm) of penicillin in the kidney of the cow.

On or about June 12, 2006, you offered for sale as human food a dairy cow identified by Back Tag 13JX3568. This cow was picked up by a cattle dealer, [redacted]. The cow was sold the same day to [redacted] where it was slaughtered on June 13,2006. The USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.23 ppm of penicillin in the kidney of the cow.

A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations , Section 556.510 (21 C.F.R. 556.510).The presence of this drug in uncooked edible tissues above the established tolerance from both of these animals causes the food to be adulterated within the meaning or 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 any 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)].

In addition, you adulterated Penicillin G Procaine 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. "Extra-label 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 extra-label 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 extra-label use of Penicillin G Procaine failed to comply with these requirements.

For example, you administered Penicillin G Procaine without following the dosage level, duration of treatment, frequency of treatment and withdrawal time for cattle 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). You used a dose higher than the label dose, treated cattle longer than the four (4) day label time, administered 20 mL of the drug at one (1) injection site rather than administering no more than 10 mL at one (1) site, and you did not use an extended withdrawal time prescribed by a veterinarian. Furthermore, your extra-label use resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Because your extra-label use of this drug was not in compliance with 21 C.F.R. Part 530, your use caused the drug to be unsafe under Section 512(a)[21 U.S.C. § 360b(a)] of the Act and adulterated within the meaning of Section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

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, our investigation found that you use sulfadimethoxine and oxytetracycline in a manner that is not in accordance with the approved labeling of these drugs. You use a mixture of approximately 120 mL oxytetracycline, 100 mL sulfadimethoxine 40%, 10 mL vitamin B12 and 2 bottles of 50% dextrose in lactated Ringer's solution and administer this to lactating dairy cows. Extra-label use of sulfadimethoxine in lactating dairy cattle is prohibited by 21 C.F.R. 530.41(a)(9).

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violation and prevent its 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 reply should be directed to Anthony P. Costello, Compliance Officer, 1 Montvale Avenue, Stoneham, MA 02180. If you have any questions about this letter you can contact Mr. Costello at 781 596-7716.


Sincerely,

/S/

Gail T. Costello
District Director
England District Office