{"abstract":"The Food and Drug Administration (FDA or we) is amending our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS). The rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. It revises FDA's regulations affirming food substances as GRAS pertaining to menhaden oil and rapeseed oil to no longer include partially hydrogenated forms of these oils, and deletes the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance. We are also revoking prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health. We are issuing these amendments directly as a final rule because they are noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives, and we anticipate no significant adverse comments because PHOs were declared no longer GRAS for any use in human food in 2015.","action":"Direct final rule.","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/2023/08/09/2023-16725.html","cfr_references":[{"chapter":null,"citation_url":null,"part":161,"title":21},{"chapter":null,"citation_url":null,"part":164,"title":21},{"chapter":null,"citation_url":null,"part":184,"title":21},{"chapter":null,"citation_url":null,"part":186,"title":21}],"citation":"88 FR 53764","comment_url":null,"comments_close_on":"2023-10-23","correction_of":null,"corrections":[],"dates":"This rule is effective December 22, 2023. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by October 23, 2023. If FDA receives no significant adverse comments within the specified comment period, we intend to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, FDA will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-4750"],"dockets":[{"supporting_documents":[{"title":"Tab C - PHOs RIA - Final to OMB","document_id":"FDA-2019-N-4750-0053"},{"title":"Tab C - PHOs NPRM - Final to OMB","document_id":"FDA-2019-N-4750-0051"},{"title":"Tab C - PHOs DFR - Final to OMB","document_id":"FDA-2019-N-4750-0050"},{"title":"Tab B - PHOs RIA - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0049"},{"title":"Tab B - PHOs PRIA - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0048"},{"title":"Tab B - PHOs NPRM - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0047"},{"title":"Tab B - PHOs DFR - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0046"},{"title":"Tab A - PHOs RIA - Original to OMB","document_id":"FDA-2019-N-4750-0045"},{"title":"Tab A - PHOs PRIA - Original to OMB","document_id":"FDA-2019-N-4750-0044"},{"title":"Memorandum to FDA DMS on Partially Hydrogenated Oils","document_id":"FDA-2019-N-4750-0041"}],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2023-08-09","updated_at":"2023-10-24T01:01:29.602-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-4750-0002","allow_late_comments":null,"id":"FDA-2019-N-4750-0002","comment_end_date":"2023-10-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":37,"id":"FDA-2019-N-4750","title":"Revocation of Uses of Partially Hydrogenated Oils in Foods "}],"document_number":"2023-16725","effective_on":"2023-12-22","end_page":53774,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/08/09/2023-16725.xml","html_url":"https://www.federalregister.gov/documents/2023/08/09/2023-16725/revocation-of-uses-of-partially-hydrogenated-oils-in-foods","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-16725?publication_date=2023-08-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-08-09/2023-16725/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":5825,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-09/pdf/2023-16725.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-16725.pdf?1691498720","publication_date":"2023-08-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/08/09/2023-16725.txt","regulation_id_number_info":{"0910-AI15":{"issue":"202304","html_url":"https://www.federalregister.gov/regulations/0910-AI15/revocation-of-uses-of-partially-hydrogenated-oils-in-foods","title":"Revocation of Uses of Partially Hydrogenated Oils in Foods","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=0910-AI15&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI15"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab C - PHOs RIA - Final to OMB","document_id":"FDA-2019-N-4750-0053"},{"title":"Tab C - PHOs NPRM - Final to OMB","document_id":"FDA-2019-N-4750-0051"},{"title":"Tab C - PHOs DFR - Final to OMB","document_id":"FDA-2019-N-4750-0050"},{"title":"Tab B - PHOs RIA - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0049"},{"title":"Tab B - PHOs PRIA - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0048"},{"title":"Tab B - PHOs NPRM - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0047"},{"title":"Tab B - PHOs DFR - Comparison OMB Original to Final","document_id":"FDA-2019-N-4750-0046"},{"title":"Tab A - PHOs RIA - Original to OMB","document_id":"FDA-2019-N-4750-0045"},{"title":"Tab A - PHOs PRIA - Original to OMB","document_id":"FDA-2019-N-4750-0044"},{"title":"Memorandum to FDA DMS on Partially Hydrogenated Oils","document_id":"FDA-2019-N-4750-0041"}],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-4750","supporting_documents_count":37,"docket_id":"FDA-2019-N-4750","document_id":"FDA-2019-N-4750-0002","regulation_id_number":null,"title":"Revocation of Uses of Partially Hydrogenated Oils in Foods ","checked_regulationsdotgov_at":"2023-10-25T01:00:07Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":53764,"subtype":null,"title":"Revocation of Uses of Partially Hydrogenated Oils in Foods","toc_doc":"Revocation of Uses of Partially Hydrogenated Oils in Foods","toc_subject":null,"topics":["Food additives","Food grades and standards","Food packaging","Frozen foods","Nuts","Peanuts","Seafood"],"type":"Rule","volume":88}