{"abstract":"The United States Environmental Protection Agency (EPA) is proposing amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). These amendments are intended to align the regulatory text with the amendments to TSCA's new chemicals review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, improve the efficiency of EPA's review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program. The proposal includes amendments that would reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review. EPA is also proposing several amendments to the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA's 1999 PBT policy.","action":"Proposed rule.","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/05/26/2023-10735.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"720","title":40},{"chapter":null,"citation_url":null,"part":"721","title":40},{"chapter":null,"citation_url":null,"part":"723","title":40},{"chapter":null,"citation_url":null,"part":"725","title":40}],"citation":"88 FR 34100","comment_url":null,"comments_close_on":"2023-07-25","correction_of":null,"corrections":[],"dates":"Comments must be received on or before July 25, 2023.","disposition_notes":null,"docket_ids":["EPA-HQ-OPPT-2022-0902","FRL-7906-01-OCSPP"],"dockets":[{"supporting_documents":[{"title":"Economic Analysis for the Final Rule: Updates to New Chemicals Regulations under the Toxic Substances Control Act (TSCA) (RIN 2070-AK65)","document_id":"EPA-HQ-OPPT-2022-0902-0104"},{"title":"Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA)","document_id":"EPA-HQ-OPPT-2022-0902-0103"},{"title":"2021 SUSB Annual Tables by Establishment Industry","document_id":"EPA-HQ-OPPT-2022-0902-0098"},{"title":"Lohmann et al. Are Fluoropolymers Really of Low Concern for Human and Environmental Health and Separate from Other PFAS","document_id":"EPA-HQ-OPPT-2022-0902-0094"},{"title":"Framework for TSCA New Chemicals Review of PFAS PMNs and SNUNs","document_id":"EPA-HQ-OPPT-2022-0902-0093"},{"title":"Chemistry Assistance Manual for Premanufacture Notification Submitters. Accessed 3-14-24.","document_id":"EPA-HQ-OPPT-2022-0902-0091"},{"title":"EPA. PFAS Strategic Roadmap EPAs Commitments to Action 2021-2024. October 18, 2021","document_id":"EPA-HQ-OPPT-2022-0902-0032"},{"title":"Premanufacture Notice Requirements and Review Procedures. Final Rule. Federal Register. 48 FR 21722. May-13-1983","document_id":"EPA-HQ-OPPT-2022-0902-0030"},{"title":"OECD. Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances. Recommendations and Practical Guidance. July 9 2021","document_id":"EPA-HQ-OPPT-2022-0902-0029"},{"title":"EPA Central Data Exchange Online User Guide Accessed on 3-29-2023","document_id":"EPA-HQ-OPPT-2022-0902-0028"}],"agency_name":"EPA","documents":[{"comment_count":53,"comment_start_date":"2023-05-26","updated_at":"2023-08-11T01:01:25.137-04:00","comment_url":"https://www.regulations.gov/commenton/EPA-HQ-OPPT-2022-0902-0001","allow_late_comments":null,"id":"EPA-HQ-OPPT-2022-0902-0001","comment_end_date":"2023-08-09","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":51,"id":"EPA-HQ-OPPT-2022-0902","title":"Updates to New Chemicals Regulations under the Toxic Substances Control Act"}],"document_number":"2023-10735","effective_on":null,"end_page":34125,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/05/26/2023-10735.xml","html_url":"https://www.federalregister.gov/documents/2023/05/26/2023-10735/updates-to-new-chemicals-regulations-under-the-toxic-substances-control-act-tsca","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-10735?publication_date=2023-05-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-05-26/2023-10735/mods.xml","not_received_for_publication":null,"page_length":26,"page_views":{"count":6440,"last_updated":"2026-06-08 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-26/pdf/2023-10735.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-10735.pdf?1685018714","publication_date":"2023-05-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/05/26/2023-10735.txt","regulation_id_number_info":{"2070-AK65":{"issue":"202410","html_url":"https://www.federalregister.gov/regulations/2070-AK65/updates-to-new-chemicals-regulations-under-the-toxic-substances-control-act-tsca-","title":"Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202410&RIN=2070-AK65&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["2070-AK65"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Economic Analysis for the Final Rule: Updates to New Chemicals Regulations under the Toxic Substances Control Act (TSCA) (RIN 2070-AK65)","document_id":"EPA-HQ-OPPT-2022-0902-0104"},{"title":"Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA)","document_id":"EPA-HQ-OPPT-2022-0902-0103"},{"title":"2021 SUSB Annual Tables by Establishment Industry","document_id":"EPA-HQ-OPPT-2022-0902-0098"},{"title":"Lohmann et al. Are Fluoropolymers Really of Low Concern for Human and Environmental Health and Separate from Other PFAS","document_id":"EPA-HQ-OPPT-2022-0902-0094"},{"title":"Framework for TSCA New Chemicals Review of PFAS PMNs and SNUNs","document_id":"EPA-HQ-OPPT-2022-0902-0093"},{"title":"Chemistry Assistance Manual for Premanufacture Notification Submitters. Accessed 3-14-24.","document_id":"EPA-HQ-OPPT-2022-0902-0091"},{"title":"EPA. PFAS Strategic Roadmap EPAs Commitments to Action 2021-2024. October 18, 2021","document_id":"EPA-HQ-OPPT-2022-0902-0032"},{"title":"Premanufacture Notice Requirements and Review Procedures. Final Rule. Federal Register. 48 FR 21722. May-13-1983","document_id":"EPA-HQ-OPPT-2022-0902-0030"},{"title":"OECD. Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances. Recommendations and Practical Guidance. July 9 2021","document_id":"EPA-HQ-OPPT-2022-0902-0029"},{"title":"EPA Central Data Exchange Online User Guide Accessed on 3-29-2023","document_id":"EPA-HQ-OPPT-2022-0902-0028"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/2070-AK65/updates-to-new-chemicals-regulations-under-the-toxic-substances-control-act-tsca-","title":"Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)"},"comments_count":53,"agency_id":"EPA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=EPA-HQ-OPPT-2022-0902","supporting_documents_count":51,"docket_id":"EPA-HQ-OPPT-2022-0902","document_id":"EPA-HQ-OPPT-2022-0902-0001","regulation_id_number":"2070-AK65","title":"Updates to New Chemicals Regulations under the Toxic Substances Control Act","checked_regulationsdotgov_at":"2023-08-12T01:00:07Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":34100,"subtype":null,"title":"Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)","toc_doc":"New Chemicals Regulations under the Toxic Substances Control Act","toc_subject":null,"topics":["Chemicals","Environmental protection","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":88}