{"abstract":"This regulation establishes an exemption from the requirement of a tolerance for residues of Escherichia coli strain K-12 P678-54 micelles (also known as E. coli K-12 derived micelles) when used as an inert ingredient (encapsulation of active ingredient) on growing crops and raw agricultural commodities pre- and post-harvest. AgroSpheres, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of E. coli K-12 derived micelles, when used in accordance with the terms of those exemptions.","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/2024/04/25/2024-08718.html","cfr_references":[{"chapter":null,"citation_url":null,"part":180,"title":40}],"citation":"89 FR 31652","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This regulation is effective April 25, 2024. Objections and requests for hearings must be received on or before June 24, 2024 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).","disposition_notes":null,"docket_ids":["EPA-HQ-OPP-2021-0681","FRL-11878-01-OCSPP"],"dockets":[{"supporting_documents":[{"title":"IN-11585; Escherichia coli strain K-12 P678-54 micelles (AgroSpheres™).\nHuman Health and Ecological Risk Assessment in Support of the Inert Ingredient \nApproval of AgroSpheres™ for use in Pesticide Formulation","document_id":"EPA-HQ-OPP-2021-0681-0004"},{"title":"AgroSpheres, Inc. Notice of Filing Pesticide Petition No. IN-11585 to establish an exemption from the requirement of a tolerance for Escherichia coli K-12 derived micelles","document_id":"EPA-HQ-OPP-2021-0681-0002"}],"agency_name":"EPA","documents":[{"comment_count":0,"comment_start_date":"2024-04-25","updated_at":"2024-09-03T16:55:19.588-04:00","comment_url":"https://www.regulations.gov/commenton/EPA-HQ-OPP-2021-0681-0003","allow_late_comments":false,"id":"EPA-HQ-OPP-2021-0681-0003","comment_end_date":"2024-06-25","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"EPA-HQ-OPP-2021-0681","title":"Petition # IN-11585, to establish an exemption from the requirement of a tolerance for Escherichia coli K-12 derived micelles, a biologically derived inert ingredient under 40 CFR §180.910 for pre- or post-harvest use as an inert ingredient in Pesticide Formulations"}],"document_number":"2024-08718","effective_on":"2024-04-25","end_page":31655,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/04/25/2024-08718.xml","html_url":"https://www.federalregister.gov/documents/2024/04/25/2024-08718/escherichia-coli-strain-k-12-p678-54-micelles-in-pesticide-formulations-tolerance-exemption","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-08718?publication_date=2024-04-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-04-25/2024-08718/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":95,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-25/pdf/2024-08718.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08718.pdf?1713962729","publication_date":"2024-04-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/04/25/2024-08718.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"IN-11585; Escherichia coli strain K-12 P678-54 micelles (AgroSpheres™).\nHuman Health and Ecological Risk Assessment in Support of the Inert Ingredient \nApproval of AgroSpheres™ for use in Pesticide Formulation","document_id":"EPA-HQ-OPP-2021-0681-0004"},{"title":"AgroSpheres, Inc. Notice of Filing Pesticide Petition No. IN-11585 to establish an exemption from the requirement of a tolerance for Escherichia coli K-12 derived micelles","document_id":"EPA-HQ-OPP-2021-0681-0002"}],"comments_count":0,"agency_id":"EPA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=EPA-HQ-OPP-2021-0681","supporting_documents_count":2,"docket_id":"EPA-HQ-OPP-2021-0681","document_id":"EPA-HQ-OPP-2021-0681-0003","regulation_id_number":null,"title":"Petition # IN-11585, to establish an exemption from the requirement of a tolerance for Escherichia coli K-12 derived micelles, a biologically derived inert ingredient under 40 CFR §180.910 for pre- or post-harvest use as an inert ingredient in Pesticide Formulations","checked_regulationsdotgov_at":"2024-06-25T04:06:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31652,"subtype":null,"title":"Escherichia coli Strain K-12 P678-54 Micelles in Pesticide Formulations; Tolerance Exemption","toc_doc":"Escherichia coli Strain K12 P67854 micelles in Pesticide Formulations","toc_subject":"Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.:\n","topics":["Administrative practice and procedure","Agricultural commodities","Environmental protection","Pesticides and pests","Reporting and recordkeeping requirements"],"type":"Rule","volume":89}