{"abstract":"EPA is finalizing narrowly tailored amendments to the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The amendments also disallow participation in third- party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). The amendments make no changes to the current Federal Policy for the Protection of Human Subjects (the \"Common Rule\"), which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies.","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/2013/02/14/2013-03456.html","cfr_references":[{"chapter":null,"citation_url":null,"part":26,"title":40}],"citation":"78 FR 10538","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective April 15, 2013.","disposition_notes":null,"docket_ids":["EPA-HQ-OPP-2010-0785","FRL-9353-4"],"dockets":[],"document_number":"2013-03456","effective_on":"2013-04-15","end_page":10546,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/02/14/2013-03456.xml","html_url":"https://www.federalregister.gov/documents/2013/02/14/2013-03456/protections-for-subjects-in-human-research-involving-pesticides","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-03456?publication_date=2013-02-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-02-14/2013-03456/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":476,"last_updated":"2026-10-24 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-02-14/pdf/2013-03456.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-03456.pdf?1360763888","publication_date":"2013-02-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/02/14/2013-03456.txt","regulation_id_number_info":{"2070-AJ76":{"issue":"201110","html_url":"https://www.federalregister.gov/regulations/2070-AJ76/protections-for-subjects-in-human-research-involving-pesticides","title":"Protections for Subjects in Human Research Involving Pesticides","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201110&RIN=2070-AJ76&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["2070-AJ76"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Documentation of Review Under E.O. 12866 (Human Subjects Revisions; FRM)","document_id":"EPA-HQ-OPP-2010-0785-0039"},{"title":"Response to Public Comments Received on the Proposed Rule Entitled “Revisions to EPA’s Rule on Protections for Subjects in Human Research Involving Pesticides\"","document_id":"EPA-HQ-OPP-2010-0785-0038"},{"title":"Documentation of EO 12866 Review (Human Subjects Revisions NPRM)","document_id":"EPA-HQ-OPP-2010-0785-0006"},{"title":"Response to FIFRA SAP Waiver Request Rule Protections for Subject in Human Research","document_id":"EPA-HQ-OPP-2010-0785-0005"},{"title":"Information Collection Request_2008_Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects_OMB No 2070-0169","document_id":"EPA-HQ-OPP-2010-0785-0004"},{"title":"Settlement Agreement Filed","document_id":"EPA-HQ-OPP-2010-0785-0003"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/2070-AJ76/protections-for-subjects-in-human-research-involving-pesticides","title":"Protections for Subjects in Human Research Involving Pesticides"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=EPA-HQ-OPP-2010-0785","supporting_documents_count":6,"docket_id":"EPA-HQ-OPP-2010-0785","regulation_id_number":"2070-AJ76","title":"Protections for Subjects in Human Research Involving Pesticides","checked_regulationsdotgov_at":"2013-03-06T08:05:32Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":10538,"subtype":null,"title":"Protections for Subjects in Human Research Involving Pesticides","toc_doc":"Protections for Subjects in Human Research Involving Pesticides","toc_subject":null,"topics":["Administrative practice and procedure","Environmental protection","Pesticides and pests"],"type":"Rule","volume":78}