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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Quesnel Livestock 11/23/09

  

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

Public Health Service
Food and Drug Administration
 New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

WARNING LETTER


NWE-07-10W


VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED


November 23, 2009


Mr. Bernard Quesnel, Co-Owner
Quesnel Livestock
1442 Route 7 North
Middlebury, VT 05753-8780


Dear Mr. Quesnel:


An inspection of your operation located in Middlebury, VT, by a Food and Drug Administration investigator on September 22, 2009, September 24, 2009, October 7, 2009 and November 4, 2009, confirmed a dairy cow identified with back tag (b)(4), ear tag # (b)(4), and farm tag (b)(4) purchased and sold by you on or about April 7, 2009, for slaughter for human food to (b)(4), was in violation of Section 402 (a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act). USDA/FSIS analyses of tissues collected from that animal disclosed the presence of the following drugs:

 

DateAnimalForm NumberUSDA Case NumberTissueDrug ResidueLevel Found (ppm)Tolerance21 CFR Reference Cite
04/08/09Dairy Cow34301809-0371-VTKidney LiverPenicillin Flunixin

0.60

0.3355

0.05

0.125

556.510

556.286



* Tolerances have been established for residues in the edible tissues of dairy cows which are codified in Title 21 Code of Federal Regulations Section 556.


In addition, USDA has reported the finding of illegal residues in other livestock sold by you and offered for slaughter for human drugs. Copies of letters from USDA/FSIS notifying you of these residues are attached.

 

DateAnimalForm NumberUSDA Case NumberTissueDrug ResidueLevel Found (ppm)Tolerance21 CFR Reference Cite
12/14/06Dairy Cow468604

06-0603-VT

07-0066-VT

KidneyPenicillin0.140.05556.510
10/11/06Bob Veal Calf10937006-0906-VT

Kidney

Muscle

Oxytetracycline

33.52

4.19

12.0

2.00

556.500
08/04/05Dairy Cow46074505-0446-VT

Kidney

Liver

Penicillin

0.23

0.16

0.05

0.05

556.510
05/06/05Dairy Cow46034805-0446-VT

Liver

Muscle

Sulfadimethoxine

0.859

1.19

0.10

0.10

556.640
10/08/02Dairy Cow44607502-1302-VT

Kidney

 

Penicillin0.220.05556.510
03/27/01Dairy Cow42998701-0649-VT

Liver

Muscle

Sulfadimethoxine

3.40

2.10

0.10

0.10

556.640
06/07/00

Dairy

Cow

40632700-0052-VTKidneyPenicillin0.090.05556.510


* Tolerances have been established for residues in the edible tissues of dairy cows which are codified in Title 21 Code of Federal Regulations 


In addition, your firm has employed poor husbandry practices by failing to take reasonable precautions to prevent the marketing and sale of animals containing illegal residues in interstate commerce. Your significant violations are as follows:


1. You have failed to implement and maintain a system to identify the animals you purchase with records to establish traceability to the source of the animal. Specifically on or about April 7, 2009 you purchased and sold a cow in interstate commerce, identified with back tag # (b)(4), ear tag # (b)(4), and farm tag # (b)(4), however you maintained no documentation as to the origin of the cow.


2. You have failed to determine from the source of the animal whether the animal has been medicated and with what drug(s). Specifically, since 2000 you have purchased and sold at least (b)(4) livestock animals for slaughter that have been found to contain violative tissue residues. You answered in the negative when asked if you inquire about the medication status of the animal from the source.


Pursuant to section 301(a) {U.S.C. § 331(a)} of the Act the introduction or delivery for introduction into interstate commerce of any food that is adulterated is prohibited.


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. The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animal. As such, you share the responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:


• If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
 

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.


This letter may not list all the violations at your facility. You are responsible for ensuring that your farm operates in compliance with the Act

 

Please send your reply to the Food and Drug Administration, Attention: Attention: Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8268 x 13.

Sincerely, 

/S/

John R. Marzilli
District Director
New England District