Inspections, Compliance, Enforcement, and Criminal Investigations
Ridgecrest Dairy, LLC 06-Jun-05
Department of Health and Human Services
Public Health Service
New York District
June 6, 2005
RETURN RECEIPT REOUESTED
David Galton, Principal Owner
Ridgecrest Dairy, LLC
1374 Indian Field Rd.
Genoa, NY 13071
File No: NYK 2005-14
Dear Mr. Galton:
On January 11 and 20, 2005, a U.S. Food and Drug Administration investigator conducted an inspection at your farm located in Genoa, New York. This inspection confirmed that you offered an animal for sale for 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) [21 U.S.C. 342(a)(2)(C)(ii) and 342(a)(4)]. The inspection also revealed that you caused a medicated feed to be adulterated within the meaning of section 501(a)(6) of the Act [21 U.S .C.351(a)(6)]. You also violated section 301(h) of the Act in that you provided a false guaranty [21 U.S .C.331].
The United States Department of Agriculture/Food Safety Inspection Service (USDA/FSIS) reported the presence of an illegal drug residue in a bob veal calf that originated from your dairy farm. On or about November 8, 2004, you offered for, sale a calf identified with sale tag Z823 to [redacted] through [redacted]. The calf was taken to [redacted] for slaughter on November 9, 2004. The USDA/FSIS laboratory's analytical report #50045935 for this bob veal calf shows that the USDA analysis detected 15.75 parts per million (ppm) neomycin in kidney tissue. The tolerances for neomycin are listed in Title 21 Code of Federal Regulations (21 CFR), Section 556 .430. The presence of neomycin at the level reported in the animal you sold causes the food to be adulterated under section 402(a)(2)(C)(ii) of the Act because it contains a new animal drug which is unsafe within the meaning of section 512 of the Act [21 U.S.C.360(b)].
On or about January 5, 2003, you provided [redacted] a signed Livestock Owner's Certificate. This certificate states that none of the livestock delivered to [redacted] would be adulterated within the meaning of the Act and that none of the livestock would have an illegal level of drug residues. On or about November 8, 2004, you, sold the above identified calf adulterated with the above discussed neomycin residue, to [redacted]. In providing this false guaranty, you are in violation of 301(h) of the Act [21
Our investigation also found that you hold animals on your farm under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain adequate control with respect to the use of medicated animal feeds for calves. It is the practice of your dairy to administer feeds medicated with neomycin to bull and heifer calves because of the higher protein content. Bull calves intended to be sold for veal are fed medicated feeds twice a day from one day of age until the day they are shipped to the livestock market for slaughter for food. This is contrary to the medicated feed label
instructions. Food from animals held under such conditions is adulterated under section 402 (a)(4) [21 U.S.C.342(a)(4)].
You adulterated the medicated feed [redacted] Calf Milk Replacer [redacted], which contains neomycin, when you used it in a calf to be processed for veal contrary to the warning on the label (i .e., "Do not use in calves to be processed for veal."). Since the Act does not permit the extra label use of medicated feeds, your actions cause this medicated feed to be unsafe under section 512(a)(2)(C) of the Act [21 U.S.C. section 360(b)] and adulterated within the meaning of section 501(a)(6) of the Act [21 U.S.C. 351(a)(6)].
You should not consider this an all-inclusive list of violations existing at your facility. 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 these violations and to establish procedures whereby such violations do not recur. Failure to achieve prompt corrective action may result in regulatory action without further notice, such as seizure and/or injunction.
USDA analysis of tissue samples collected from two additional calves from your farm also revealed illegal drug residues. These include a calf bearing sale tag Z860 sold March 15, 2004, through [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of 5.22 ppm neomycin in kidney tissue. Another calf, bearing sale tag Z233 was sold December 29, 2003, through [redacted]. USDA analysis of tissue samples collected from that animal identified the presence 1.42ppm
neomycin in kidney tissue
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 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 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step you have taken or will take to prevent the recurrence of similar violations. 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 response should be directed to Richard T. Trainor, Compliance Officer, at the following address: FDA, 300 Hamilton Ave., White Plains, New York 10601.
Jerome G: Woyshner