Sunset Dairy 9/21/12

WARNING LETTER
12-PHI-31

SEP 21, 2012                                   

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Todd A Benedict, Owner
Sunset Dairy
19435 Route 957
Bear Lake, PA 16402

Dear Mr. Benedict:

On August 24, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 19435 Route 957, Bear Lake, PA.  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 an animal for slaughter as food that was 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 June 5, 2012, you sold a dairy cow, identified with ear/bangle tag # (b)(4) , for slaughter as food.  On or about June 6, 2012, (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 Desfuroylceftiofur at 8.52 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.4 parts per million (ppm) for residues of Ceftiofur in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (21 C.F.R. 556.113).  The USDA/FSIS testing also identified the presence of Flunixin at 0.851 parts per million (ppm) in the kidney. FDA has established a tolerance of 125 parts per billion (ppb) for residues of Flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.286 (21 CFR 556.286).  The presence of these drugs in edible tissue(s) from this animal in these amounts causes 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)].

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 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)].

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 and/or 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 Yvette Johnson, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106.  If you have any questions about this letter, please contact Ms. Johnson at (215) 717-3077 or e-mail at Yvette.Johnson@fda.hhs.gov.

Sincerely,

/S/

Kirk Sooter
District Director
Philadelphia District