Inspections, Compliance, Enforcement, and Criminal Investigations
Brown's Livestock 22-Jun-04
Department of Health and Human Services
Public Health Service
Baltimore District Office
June 22, 2004
RETURN RECEIPT REQEUSTED
Mr. Andrew E. Brown, Owner
107 Redwood Lane
Winchester, Virginia 22603-4230
Dear Mr. Brown:
An inspection of your cattle dealer operations located at 107 Redwood Lane, Winchester, Virginia 22603-4230 was conducted by FDA Investigator Dianne H. Milazzo on March 3, 19, and 23, 2004. The inspection confirmed that you offered five bob veal calves for sale for slaughter as food that was adulterated within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).
Between October 2, 2003, and February 16, 2004, you delivered numerous bob veal calves for sale at [redacted] Pennsylvania [redacted] The bob veal calves were sold to [redacted] Pennsylvania, where they were slaughtered as human food. United States Department of Agriculture/Food Safety Inspection Service analysis of tissue samples collected from these animals found the drug neomycin in edible tissues. The table below lists the neomycin levels, in parts per million (ppm), found in the kidney tissue of these animals:
|Back Tag #||USDA Lab #||neomycin (ppm)||Slaughter date|
|3172||449271||18.98||February 17, 2004|
|2828||435018||9.16||November 12, 2003|
|2826||435013||2.27||November 11, 2003|
|3236||434751||2.88||October 3, 2003|
|3244||434752||2.50||October 3, 2003|
Neomycin has not been approved for use in calves intended for veal and there is no established tolerance for residues of neomycin in the edible tissues of calves (Title 21, Code of Federal Regulations, section 556.430). The presence of neomycin in the edible tissues of these animals 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 which are ultimately offered for sale for slaughter as human food under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you stated that prior to November 24, 2003, you did not keep any records of the animals that you purchased from producers in southwest Virginia. In addition, you failed to have a system in place to determine the medicated status of the animals that you offered for sale as human food.
It is not necessary for you to have personally shipped the animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
The violations listed above are not intended to be an all inclusive list. 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 injunction. This letter notifies you of our findings and provides you with an opportunity to correct the above deficiencies.
You should notify this office, in writing, within fifteen (15) working days of receipt of this letter, of the specific steps taken to correct the noted violations. Your response should include each step being taken to prevent reoccurrence of similar violations. If corrective actions cannot be completed within 15 working days, please state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Randy F. Pack, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions regarding any issue in this letter, please contact Mr. Pack at 410-779-5417.