{"abstract":"EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms in order to qualify for the exemption from full notification and reporting procedures under the Toxic Substances Control Act (TSCA) for new microorganisms that are being manufactured for introduction into commerce. Based on EPA's evaluation of these petitions, EPA has made a preliminary 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. Therefore, EPA is proposing to add two additional microorganisms to the list of recipient microorganisms that are eligible for exemptions from full reporting for the manufacture (including import) of new microorganisms.","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/2012/09/05/2012-21843.html","cfr_references":[{"chapter":null,"citation_url":null,"part":725,"title":40}],"citation":"77 FR 54499","comment_url":null,"comments_close_on":"2012-11-05","correction_of":null,"corrections":[],"dates":"Comments must be received on or before November 5, 2012.","disposition_notes":null,"docket_ids":["EPA-HQ-OPPT-2011-0740","FRL-9348-1"],"dockets":[],"document_number":"2012-21843","effective_on":null,"end_page":54511,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/09/05/2012-21843.xml","html_url":"https://www.federalregister.gov/documents/2012/09/05/2012-21843/microorganisms-general-exemptions-from-reporting-requirements-revisions-to-recipient-organisms","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-21843?publication_date=2012-09-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-09-05/2012-21843/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":496,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-09-05/pdf/2012-21843.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-21843.pdf?1346762939","publication_date":"2012-09-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/09/05/2012-21843.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":"2012-11-07T05:01:23Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":54499,"subtype":null,"title":"Microorganisms; General Exemptions From Reporting Requirements; Revisions to Recipient Organisms Eligible for Tier I and Tier II Exemptions","toc_doc":"Revisions to Recipient Organisms Eligible for Tier I and Tier II Exemptions","toc_subject":"Microorganisms; General Exemptions from Reporting Requirements:","topics":["Administrative practice and procedure","Chemicals","Environmental protection","Hazardous substances","Imports","Labeling","Occupational safety and health","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":77}