Recent Enforcement Letter Indicates FDA Gets Serious About Bute Ban
Ronald Andio, DBA Patron Farms, LLC 7/9/12
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
July 9, 2012
Via United Parcel Service
Mr. Ronald A. Andio, Owner
Ronald Andio, DBA Patron Farms, LLC
4445 South Turner Road
Canfield, Ohio 44406
Dear Mr. Andio:
On April 03, 05, and 30, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at 4445 South Turner Road, Canfield, Ohio 44406. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 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 August 20, 2011, you sold a bay thoroughbred gelding horse, identified with back tag (b)(4) (USDA Tag (b)(4)) for slaughter as food. On or about August 23, 2011, (b)(4) slaughtered this animal. The Canadian Food Inspection Agency (CFIA) analysis of tissue samples collected from this animal identified the presence of phenylbutazone at 0.0025 parts per million (ppm) in the muscle tissue and 0.026 ppm in the kidney tissue and clenbuterol at 0.0039 ppm in the eye (target tissue). FDA has not established a tolerance for residues of phenylbutazone and clenbuterol in the edible tissues of horses. The presence of these drugs in edible tissues 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 inquire about the medication status of animals purchased for slaughter. 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 violations listed above are not intended to an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animals. As such, you share responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to determine from the source of the animals whether the animals has been medicated and with what drug(s); and
2. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
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.
We also note that the slaughterhouse has on file an Equine Information Document (EID) certificate (or guarantee) dated August 23, 2011 from the producer stating that this animal that you sold had not been administered any drugs or vaccines or treated with any substances not permitted for use in food processing equine in the last 180 days prior to your purchase of this animal. During our inspection of your firm, you admitted that you filled out and signed the producer’s name to this form and did not inquire of the producer the medication status of this animal. You provided this EID to the dealer who purchased this animal from you. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 Mr. Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Mark E. Parmon at (513) 679-2700, Ext. 2162, (513) 679-2773 (fax), or email: firstname.lastname@example.org.
Paul J. Teitell
cc: Dr. Tony Forshey, Acting Chief
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399