DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration Silver Spring, MD 20993

September 25, 2014 Control Number: 2012-4048 Anne Weismann CREW 1400 Eye Street N.W., Suite 450 Washington, D.C. 20005 Dear Ms. Weisman: Thank you for your request for records in connection with Representative Renacci or Suarez Corporation Industries. In response to your request for records from the Food and Drug Administration pursuant to the Freedom of Information Act: ___ After searching our files, we did not find the requested records. ___ We have no disclosable information as requested. _x_ We are enclosing the requested records. ___ This is a partial response. Further response will be made. Certain material may have been deleted from the records furnished to you because a preliminary review of the records indicated that the deleted information is not required to be publicly disclosed and that disclosure is not appropriate. FDA has taken this approach to facilitate the process of responding to you. Any deletions were conducted pursuant Exemptions (b)(4), (b)(5) and (b)(6). If you dispute FDA’s preliminary determination with respect to these records and would like FDA to reconsider a particular deletion, please let us know in writing at the address listed below within 30 days from the date of this letter. If we do not receive a response in that time period, we will consider the matter closed with respect to these records. If you do request further consideration and if the agency then formally denies your request for any or all of the previously-withheld information, you will have the right to appeal that decision. Any letter of denial will explain how to make this appeal. Responses can be mailed to the following address: Division of Freedom of Information

Office of the Executive Secretariat U.S. Food & Drug Administration 5630 Fishers Lane, Room 1035

Rockville, MD 20857 The following charges may be included in a monthly invoice:

Reproduction: $0.00 Search: $0.00 Review: $0.00 Other: $0.00 TOTAL: $0.00

The above total may not reflect final charges for this request. PLEASE DO NOT SEND PAYMENT UNLESS YOU RECEIVE AN INVOICE FOR THE TOTAL MONTHLY FEE. If there are any problems with this response, please notify us in writing of your specific problem(s). Please reference the above file number. Please do not hesitate to contact me at (240) 276-9120. Gorka Garcia-Malene FOIA Officer for the Center for Veterinary Medicine United States Food and Drug Administration

The Honorable James B. Renacci

Member, U.S. House of Representatives

1 Park Center Drive, Suite 302

Wadsworth, OH 44281-9482

Dear Mr. Renacci:

Thank you for your letter of March 4, 2013, on behalf of your constituent, Mr. Martin

Yoder of Kidron, Ohio, the owner of Martin D. Yoder Livestock. In your letter, you

request additional information about the Food and Drug Administration’s (FDA or the

Agency) against Mr. Yoder

for his violations of a consent decree of permanent injunction (Consent Decree).

A recent FDA inspection, conducted between September 5 to 28, 2012, and November 15

to 29, 2012, revealed that Mr. Yoder has not met key requirements of the Consent

Decree. The Consent Decree settled a permanent injunction proceeding that the Agency

initiated against Mr. Yoder because of his sustained behavior of selling animals for use as

human food that contained excessive and illegal drug residues in their edible tissues. The

recent inspection found that Mr. Yoder failed to to prevent the

sale of animals with above-tolerance drug residues for use as human food.

Above-tolerance drug levels in edible tissue pose a public health risk

human consumers. Consumers sensitive to who

consume edible tissues containing above-tolerance experience

allergic reactions, swelling of the skin,

above-tolerance drug residues also contributes to the

strains of bacteria

Above-tolerance drug residues lead to

gastrointestinal effects, diarrhea inflammation of the colon.

Though the matter has not yet been resolved, FDA continues to

The Agency has no further

comments on this ongoing regulatory matter at this time,

Thank you, again, for contacting us concerning this matter. If you have further questions,

please let us know.

Sincerely,

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Page 2 – The Honorable James B. Renacci

Kristina Harper

Supervisory Congressional

Affairs Specialist

Page 3 – The Honorable James B. Renacci

Rec’d in OL: 3/13/13

Referred to OCC: 3/13/13

Draft: DGaskin, OCC: 3/27/13

OL rec’d OCC draft: 3/27/13

Minor edits: MStringfellow: 3/27/13

Edits: MStringfellow: 3/28/13

Cleared w/ edits: PBroadbent: 3/29/13

OCC cleared: DGaskin: 4/1/13

Control #: 2013-1784

G:\WP\STRINGFELLOW\Antimicrobial Resistance\2013-1784 Renacci (c) Yoder

Livestock_03-28-13.doc

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