{"abstract":"EPA is issuing a final rule to add Trichoderma reesei (T. reesei) strain QM6a and its derivatives and Bacillus amyloliquefaciens (B. amyloliquefaciens) subspecies (subsp.) amyloliquefaciens to the list of recipient microorganisms that may be used to qualify for the Tier I and Tier II exemptions from full notification and reporting procedures under the Toxic Substances Control Act (TSCA) for new microorganisms that are being manufactured for introduction into commerce. EPA received petitions to add T. reesei and B. amyloliquefaciens to the list of microorganisms eligible for the exemption from full notification and reporting procedures under the TSCA for new microorganisms. Based on EPA's evaluation of these petitions, EPA has made the determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism provided that certain criteria for the introduced genetic material and the physical containment conditions are met.","action":"Final 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/2020/03/10/2020-04746.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"725","title":40}],"citation":"85 FR 13760","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective April 9, 2020.","disposition_notes":null,"docket_ids":["EPA-HQ-OPPT-2011-0740","FRL-9991-60"],"dockets":[],"document_number":"2020-04746","effective_on":"2020-04-09","end_page":13773,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/10/2020-04746.xml","html_url":"https://www.federalregister.gov/documents/2020/03/10/2020-04746/microorganisms-general-exemptions-from-reporting-requirements-revisions-to-recipient-organisms","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-04746?publication_date=2020-03-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-10/2020-04746/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":2063,"last_updated":"2026-09-21 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-10/pdf/2020-04746.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-04746.pdf?1583757924","publication_date":"2020-03-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/10/2020-04746.txt","regulation_id_number_info":{"2070-AJ65":{"issue":"201910","html_url":"https://www.federalregister.gov/regulations/2070-AJ65/microorganisms-general-exemptions-from-reporting-requirements-revisions-of-recipient-organisms-eligi","title":"Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=2070-AJ65&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["2070-AJ65"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Meeting with ETA 11.5.2019 Sign In sheet","document_id":"EPA-HQ-OPPT-2011-0740-0024"},{"title":"Meeting With The Enzyme Technical Association 2019","document_id":"EPA-HQ-OPPT-2011-0740-0023"},{"title":"Enzyme Technical Association's Presentation At 2018 Meeting With EPA","document_id":"EPA-HQ-OPPT-2011-0740-0022"},{"title":"Meeting With The Enzyme Technical Association 2018","document_id":"EPA-HQ-OPPT-2011-0740-0021"},{"title":"Final Rule Economic Analysis","document_id":"EPA-HQ-OPPT-2011-0740-0020"},{"title":"Ref 12.  Nevalainen, Suominen, and Taimisto. 1994. On The Safety Of Trichoderma Reesei. J. Biotechnol. 37:193-200","document_id":"EPA-HQ-OPPT-2011-0740-0019"},{"title":"40 CFR Parts 700, 720, 721, 723, and 725 Microbial Products of Biotechnology; Final Regulation under the Toxic Substances Control Act; Final Rule. April 1997","document_id":"EPA-HQ-OPPT-2011-0740-0014"},{"title":"40 CFR Parts 700, 720, 721, 723, and 725 Microbial Products of Biotechnology; Proposed Regulation under the Toxic Substances Control Act; Proposed Rule. September 1994","document_id":"EPA-HQ-OPPT-2011-0740-0013"},{"title":"Legislative History or the Toxic Substances Control Act","document_id":"EPA-HQ-OPPT-2011-0740-0012"},{"title":"Economic Analysis for the Proposed Biotechnology Exemptions Rule for Trichoderma reesei and Bacillus amyloliquefaciens (EPA 2011)","document_id":"EPA-HQ-OPPT-2011-0740-0011"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/2070-AJ65/microorganisms-general-exemptions-from-reporting-requirements-revisions-of-recipient-organisms-eligi","title":"Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=EPA-HQ-OPPT-2011-0740","supporting_documents_count":19,"docket_id":"EPA-HQ-OPPT-2011-0740","regulation_id_number":"2070-AJ65","title":"Microorganisms: General Exemptions from Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions","checked_regulationsdotgov_at":"2020-03-12T09:00:30Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":13760,"subtype":null,"title":"Microorganisms; General Exemptions From Reporting Requirements; Revisions to Recipient Organisms Eligible for Tier I and Tier II Exemptions","toc_doc":null,"toc_subject":null,"topics":["Administrative practice and procedure","Chemicals","Environmental protection","Hazardous substances","Imports","Labeling","Occupational safety and health","Reporting and recordkeeping requirements"],"type":"Rule","volume":85}