Inspections, Compliance, Enforcement, and Criminal Investigations
Jones Brothers Dairy LLC 22-Feb-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
240 Hennepin Avenue
Minneapolis, MN 55401.1999
February 22, 2002
RETURN RECEIPT REQUESTED Refer to MIN 02 - 26
Wayne L. Jones
Jones Brothers Dairy, LLC
1762 Highway 78s
Mount Horeb, Wisconsin 53572
Dear Mr. Jones:
An investigation at your dairy farm located at Mount Horeb, WI, conducted by our
investigator on January 9, 2002, confirmed that you offered animals for sale for slaughter as food in violation of Sections 402(a)(2)( c ii and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), and that you may have caused animal drugs to become adulterated within the meaning of Section 50 l(a)(5).
On or about November 15, 2001, you sold a dairy cow identified with back tag
number 35DP7368 to [redacted]. This animal was subsequently sold for slaughter as human food at [redacted] U.S. Department of Agriculture (USDA) analysis of tissue samples collected from this cow identified the presence of sulfadimethoxine at 4.09 ppm in the liver and 5.53 ppm in muscle. A tolerance of 0.1 ppm has been established for
residues of sulfadimethoxine in the edible tissues of cattle (Title 2 1, Code of Federal
Regulations, Part 556.640). The presence of this drug in edible tissue from this
animal causes the food to be adulterated.
Our investigation also found that you hold animals under conditions which are so
inadequate that diseased animals and/or medicated animals bearing potentially
harmful drug residues are likely to enter the food supply. For example, you lack
an adequate system for assuring that drugs are used in a manner not contrary to
the directions contained in the labeling and for assuring 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 tissue. As noted in
the form FDA-483 issued to you on January 9, 2002, you did not maintain records
of the treatment of dairy cows to avoid sale of animals bearing residual drugs in
edible tissues. Foods from animals held under such conditions are adulterated.
You are adulterating [redacted] brand of sulfadimethoxine that your firm uses on
dairy cattle within the meaning of Section 501 (a)(5) when you fail to use the drug in
conformance with its approved labeling. Your use of sulfadimethoxine in dairy
cattle either at higher than labeled dosages or without following the labeled
withdrawal period causes the drug to be unsafe to use.
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 foods you distribute are 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.
It is not necessary for you to personally ship 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 and subsequently offered for sale to a
slaughterhouse that ships in interstate commerce is sufficient to hold you
responsible for a violation of the Act.
You should notify this office in writing within 15 working days of the steps you
have taken to bring your firm into compliance with the law. Your response should
include each step being taken, that has been taken or will be taken to correct the
violations and prevent their recurrence. If corrective action cannot be completed
within 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 Compliance Officer Timothy G. Philips at the
address indicated on the letterhead.
David R. Yost