Profit & Loss Dairy 12/7/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128

December 7, 2010
 

2011-DAL-WL-04

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Peter H. Schouten, Owner
Profit and Loss Dairy
3728 County Road 229
Hico, Texas 76547
 

Dear Mr. Schouten:
 

On July 14 and 16, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 3728 County Road 229, Hico, Texas. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C 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 the FDA's web page at www.fda.gov.
 

We found that you offered for sale animals that were slaughtered as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 December 3, 2009, you sold two bob veal calves, identified with ear tags (b)(4) and (b)(4) for slaughter as food. On or about December 3, 2009, (b)(4) slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of neomycin in the kidney of each animal at 15.26 parts per million (ppm).
 

FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to use of (b)(4) Neomycin Oral Solution, ANADA (b)(4), in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with use of (b)(4) Neomycin Oral Solution, ANADA (b)(4) in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from these animals in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).
 

In addition, our investigation revealed that on or about January 12, 2010, you sold a bob veal calf, identified with ear tag (b)(4) for slaughter as food. On or about January 12, 2010, (b)(4) dba (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin in the kidney at 16.36 ppm. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). However, this tolerance does not apply to use of (b)(4) Neomycin Oral Solution, ANADA (b)(4) in veal calves (pre-ruminating calves), and there is no acceptable level  of residue associated with use of (b)(4) Neomycin Oral Solution, ANADA (b)(4). in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).
 

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. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).
 

We also found that you adulterated the new animal drug (b)(4) Neomycin Oral Solution, ANADA (b)(4) Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
 

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 CFR Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
 

Our investigation found that you administered (b)(4) Neomycin Oral Solution, ANADA (b)(4) to three bob veal calves, identified with ear tags (b)(4) and (b)(4) without following the indicated animal class as stated in the approved labeling. Durvet Neomycin Oral Solution, ANADA (b)(4) is not approved for use in calves to be processed for veal and your extralabel use of (b)(4) Neomycin Oral Solution, ANADA (b)(4) resulted in three illegal drug residues, all in violation of 21 C.F.R. 530.11(c). Because your extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351 (a)(5).
 

In addition, you adulterated the animal feed (whole milk), within the meaning of section 501 (a)(6) of the FD&C Act, 21 U.S.C. 351 (a)(6), when you added (b)(4) Neomycin Oral Solution, ANADA (b)(4) to the whole milk, and when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Section 512 of the FD&C Act, 21 U.S.C. 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
 

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 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.
 

We remind you that on January 07, 2001, a Warning Letter was issued to Mr. Peter H. Schouten, owner, P & L Schouten Dairy, Route 1, Box 452 / CR 229, Hico, Texas 76457. A copy of the Warning Letter dated January 7, 2001, is provided for your review and information.
 

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, 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 Ronda Loyd-Jones, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Ronda Loyd-Jones at 214-253-5220.
 

Sincerely,
/S/

Reynaldo R. Rodriquez,
Dallas District Director

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