Inspections, Compliance, Enforcement, and Criminal Investigations
John M. Bridges Farm 18-Jul-02
Food and Drug Administration
Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309
July 18, 2002
VIA FEDERAL EXPRESS
John M. Bridges, Owner
John M. Bridges Farm
c/o Bridges Market
1675 E. Marion Street
Shelby, North Carolina 28150
Dear Mr. Bridges:
An investigation of your cattle operation by Investigator Richard L. Garcia on June 6 & 7, 2002, confirmed that you offered an animal for sale for slaughter as food, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The animal was adulterated food within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Act.
On or about April 17, 2002, you sold a cow, identified with tag #56HB4227, to [redacted] in [redacted] South Carolina. This cow was sold for slaughter as human food, The United State Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS) analysis of tissue collected from that animal (Case No. 8-0576-02) disclosed the presence of high levels of the drug penicillin in the kidney and liver tissue. The liver was found to contain 1.08 ppm and the kidney contained .43 ppm of penicillin.
The tolerance established for residues of penicillin in the edible tissues of cattle is .05 ppm. This tolerance is listed in Title 21, Code of Federal Regulations, Part 556.510. The presence of this drug, at levels above the tolerance, in edible tissue from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.
Our investigation also found that you hold animals under conditions that could allow medicated animals, bearing potentially harmful drug residues, to enter the food supply. For example, you lack an adequate system for assuring that animals which have been treated are withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. You have failed to assure that drugs are not used in a manner control to the directions contained in the labeling. Investigator Garcia found that you had no animal, medication records that would identify which animal had been medicated, what type of medication had been used, and what the withdrawal times should be. Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act.
The above-identified violations are not intended to be an all-inclusive list of deficiencies at your cattle farm. Investigator Garcia issued a list of Inspectional Observations (FDA 483) to you at the conclusion of his visit. As a producer of animals offered for use as food, you are responsible for assuring 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 enforcement action being initiated by the FDA without further notice such as seizure and/or injunction.
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 is 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.
Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.
Your reply should be sent to the attention of Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.
Ballard H. Graham