Inspections, Compliance, Enforcement, and Criminal Investigations
Longway Farm 10/5/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
VIA United Parcel Post
October 5, 2010
Richard Longway, Co-owner
281 County Road
Swanton, Vermont 05488-2110
Dear Mr. Longway:
On August 16, 17, 19 and 23, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 281 County Road, Swanton, Vermont. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about March 15, 2010 you sold one (1) bob veal calf with tag number (b)(4) food. On or about March 16, 2010 (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 17.53 ppm neomycin in the kidney tissues for bob veal calf tag number (b)(4) On or about March 29, 2010 you sold two (2) bob veal calves with tag numbers (b)(4) as food. On or about March 30, 2010 (b)(4) slaughtered these animals. United States Department 0 gncu ture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of 21.58 ppm and 8.25 ppm neomycin in the kidney tissues for bob veal calf tag numbers (b)(4) FDA has established a tolerance of 7.2 ppm for neomycin in the kidneys for cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. § 556.430). The presence of this drug in the kidneys from these animal in these amounts cause the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, (21 U.S.C. § 342(a)(2)(C)(ii)).
Animal Tag# Date Sold Date Slaughtered Amount Neomycin found in Kidney(ppm) Bob Veal Calf (b)(4) 3/15/2010 3/16/2010 17.53 Bob Veal Calf (b)(4) 3/29/2102 3/30/2010 21.58 Bob Veal Calf (b)(4) 3/29/2010 3/30/2010 8.25
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure 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 tissues. For example, you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342 (a)(4)].
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 food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure andlor injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, 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 written response should be sent to Bruce R. Ota, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about this letter, please contact Compliance Officer Mr. Ota at 781-596-7762.
Mutahar S. Shamsi
Acting District Director
New England District