Inspections, Compliance, Enforcement, and Criminal Investigations
John Potter Farm, LLC 28-Aug-06
Department of Health and Human Services
Public Health Service
New England District
August 28, 2006
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Timothy M. Potter, Owner
John Potter Farm, LLC
54 Sunny Ridge Road
Washington, CT 06793
Dear Mr. Potter:
A tissue report received by the U.S. Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a cow that originated from your dairy farm. An inspection of your dairy farm located at 54 Sunny Ridge Road, Washington, Connecticut was conducted by Food and Drug investigators on June 6 and 13, 2006, as a follow-up to this reported residue confirmed that you offered a dairy cow for sale for slaughter as human food in violation of sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).
You treated a dry dairy cow on your farm identified with farm tag # 3409 with sulfadimethoxine. On February 6, 2006, the cow with farm tag # 3409 was transported by [redacted] a livestock hauler to [redacted] on February 2006 the cow with farm tag # 3409 was sold to [redacted]. The cow with farm tag # 3409 was then transported to [redacted] on February 6, 2006. USDA analysis of tissue samples collected on February 7, 2006 from that animal identified the presence of sulfadimethoxine in the animal's liver at 1.06 ppm and animal's muscle tissue at 0.56 ppm. The established tolerance for sulfadimethoxine in cattle is 0.1 ppm (21 CFR 556.640). The presence in edible tissue of this animal of sulfadimethoxine in levels that exceed the established tolerance causes the food to be adulterated within the meaning of section 402(a)(2)(c)(ii) of the Act.
A food is adulterated under section 402(a)(2)(C)(ii) of the Act, if it contains a new animal drug which is unsafe within the meaning of section 512. Likewise, a food is adulterated under section 402(a)(4) of the Act if it has been prepared, packed, or held under insanitary conditions . . . whereby it may have been rendered injurious to health. As it applies in this case, "insanitary conditions" means that you hold animals, which are ultimately offered for sale for slaughter as food, under conditions that may allow medicated animal bearing possibly harmful drug residue to enter the food supply.
For example, our investigators noted the following conditions on your farm:
1. You lack an adequate record keeping system for determining the medication status of animals you offer for slaughter.
2. You lack an adequate record system for assuring that animals to which you administer medication, have been withheld from slaughter for appropriate periods of time to deplete potentially hazardous residues of drugs.
3. You lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in their labeling.
This letter is not intended to be an all-inclusive list of violations. As a producer of animals which are offered for use as food, you are responsible for assuring that your overall operation and the food you distribute are in compliance with the law.
You should be aware that it is not necessary for you to have personally shipped an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold to a slaughterhouse engaged in interstate commerce is sufficient to hold you responsible for a violation of the Act.
You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. This letter constitutes official notification under the law.
You should notify this office in writing with fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrections 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. Also include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Bruce R. Ota, Compliance Officer, Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions you can contact Mr. Ota at the above phone number.
Gail T. Costello