{"abstract":"The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing an order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. An approved method is required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as implemented by regulation, to show that no residue of carcinogenic concern from a new animal drug persists in any edible tissue or in any food derived from treated animals. The currently approved method measures quinoxaline-2-carboxylic acid (QCA) as a marker residue to detect the presence of any residue of carcinogenic concern. CVM is proposing to revoke the approved method for carbadox based on our determination that it is inadequate to monitor residue of carcinogenic concern in compliance with FDA's operational definition of no residue because there is no established relationship between QCA measured by the approved method and the residue of carcinogenic concern.","action":"Proposed order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2020/07/20/2020-15246.html","cfr_references":[],"citation":"85 FR 43853","comment_url":null,"comments_close_on":"2020-09-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed order by September 18, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0832"],"dockets":[{"supporting_documents":[{"title":"Exhibit 7 Expert Opinion of Stephen Scypinski, Ph.D. re: Request for Hearing from Phibro Animal Health Corporation Redacted CV","document_id":"FDA-2016-N-0832-0043"},{"title":"Exhibit 2 Expert Opinion of David H. Bechtel, Ph.D., D.A.B.T. re: Request for Hearing from Phibro Animal Health Corporation Redacted CV","document_id":"FDA-2016-N-0832-0040"},{"title":"Exhibit 20 Corey Grass, C. F. Grass Consulting, Impact & Cost if Mecadox Was Not Available (June 2016) re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0038"},{"title":"Exhibit 15 A.C.J. Gresham, et al Treatment of Swine Dysentery Problems of Antibiotic Resistance and Concurrent Salmonellosis, 143 Vet. Rec. 619 (1998) re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0037"},{"title":"Exhibit 14 M. Karlsson, et al Decreased Susceptibility to\nTiamulin in German Isolates of Brachyspira hyodysenteriae (Paper 43), Proc. 17th Int. Pig Vet. Soc. Cong., Ames, Iowa (2002) re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0036"},{"title":"Exhibit 12 R. Korty, et al A Cost Effective Alternative to Finishing Depopulation for Swine Dysentery, Am. Ass. Swine Vet. re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0035"},{"title":"Exhibit 10 Declaration of Kevin Bynum re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0033"},{"title":"Exhibit 9 Declaration of Paul Duquette re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0032"},{"title":"Exhibit 6 FDA Location Directory (July 1990)  re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0031"},{"title":"Exhibit 5 Proceedings of the EuroResidue Conference, Noorwijkerhout re: Request for Hearing from Phibro Animal Health Corporation","document_id":"FDA-2016-N-0832-0030"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-07-20","updated_at":"2023-02-28T22:52:30.300-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-0832-0069","allow_late_comments":null,"id":"FDA-2016-N-0832-0069","comment_end_date":"2020-07-21","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":38,"id":"FDA-2016-N-0832","title":"Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing"},{"supporting_documents":[{"title":"Reference 12 - Memorandum to File entitled, CVM review of comments on the Zhang Article that Phibro references in the document submitted to the Part 15 Hearing docket under cover letter dated June 9, 2022, and entitled, Phibro Animal Health Corporation’s Reply to the January 6, 2022 CVM Response to Phibro Animal Health Corporation’s September 18, 2020 Comments on CVMs July 20, 2020 Proposed Or","document_id":"FDA-2020-N-0955-0054"},{"title":"Reference 11 - Memorandum to File entitled, “CVM’s review of documents Phibro submitted to Docket No. FDA-2021-N-1326 and presentation at the March 10, 2022 Part 15 Hearing” (October 30, 2023) RE Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method","document_id":"FDA-2020-N-0955-0053"},{"title":"Reference 6 - Memorandum to File entitled, “CVM Response to Phibro Animal Health Corporation’s September 18, 2020 Comments on CVM’s July 20, 2020 Proposed Order to Revoke the Regulatory Method for Carbadox” (January 6, 2022) RE Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method","document_id":"FDA-2020-N-0955-0052"},{"title":"Memo from FDA DMS to Phibro","document_id":"FDA-2020-N-0955-0050"},{"title":"Exhibit  A - Impact & Cost if Mecadox Not Available re: Petition from Covington & Burling LLP AND Petition for Stay of Action from Covington & Burling LLP","document_id":"FDA-2020-N-0955-0049"},{"title":"Reference List for Phibro Animal Health Corp; Carbadox in Medicated Swine Feed; Revocation of Approved Method (85 FR 43853)","document_id":"FDA-2020-N-0955-0007"}],"agency_name":"FDA","documents":[{"comment_count":40,"comment_start_date":"2020-08-14","updated_at":"2023-02-28T22:52:29.847-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-0955-0006","allow_late_comments":null,"id":"FDA-2020-N-0955-0006","comment_end_date":"2020-09-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":6,"id":"FDA-2020-N-0955","title":"Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method; CLOSED"}],"document_number":"2020-15246","effective_on":null,"end_page":43858,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/20/2020-15246.xml","html_url":"https://www.federalregister.gov/documents/2020/07/20/2020-15246/phibro-animal-health-corp-carbadox-in-medicated-swine-feed-revocation-of-approved-method","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-15246?publication_date=2020-07-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-20/2020-15246/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":2797,"last_updated":"2026-07-28 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-20/pdf/2020-15246.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-15246.pdf?1594989922","publication_date":"2020-07-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/20/2020-15246.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 12 - Memorandum to File entitled, CVM review of comments on the Zhang Article that Phibro references in the document submitted to the Part 15 Hearing docket under cover letter dated June 9, 2022, and entitled, Phibro Animal Health Corporation’s Reply to the January 6, 2022 CVM Response to Phibro Animal Health Corporation’s September 18, 2020 Comments on CVMs July 20, 2020 Proposed Or","document_id":"FDA-2020-N-0955-0054"},{"title":"Reference 11 - Memorandum to File entitled, “CVM’s review of documents Phibro submitted to Docket No. FDA-2021-N-1326 and presentation at the March 10, 2022 Part 15 Hearing” (October 30, 2023) RE Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method","document_id":"FDA-2020-N-0955-0053"},{"title":"Reference 6 - Memorandum to File entitled, “CVM Response to Phibro Animal Health Corporation’s September 18, 2020 Comments on CVM’s July 20, 2020 Proposed Order to Revoke the Regulatory Method for Carbadox” (January 6, 2022) RE Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method","document_id":"FDA-2020-N-0955-0052"},{"title":"Memo from FDA DMS to Phibro","document_id":"FDA-2020-N-0955-0050"},{"title":"Exhibit  A - Impact & Cost if Mecadox Not Available re: Petition from Covington & Burling LLP AND Petition for Stay of Action from Covington & Burling LLP","document_id":"FDA-2020-N-0955-0049"},{"title":"Reference List for Phibro Animal Health Corp; Carbadox in Medicated Swine Feed; Revocation of Approved Method (85 FR 43853)","document_id":"FDA-2020-N-0955-0007"}],"comments_count":40,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-0955","supporting_documents_count":6,"docket_id":"FDA-2020-N-0955","document_id":"FDA-2020-N-0955-0006","regulation_id_number":null,"title":"Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method; CLOSED","checked_regulationsdotgov_at":"2023-03-01T03:52:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43853,"subtype":null,"title":"Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method","toc_doc":"Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed","toc_subject":"Revocation of Approved Method:\n","topics":[],"type":"Notice","volume":85}