{"abstract":"The Environmental Protection Agency (EPA) is exempting a class of plant-incorporated protectants (PIPs) that have been created using genetic engineering from certain registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the requirements to establish a tolerance or tolerance exemption for residues of these substances on food or feed under the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, EPA is finalizing its exemptions as described in its October 2020 proposal for PIPs now termed \"PIPs created through genetic engineering from a sexually compatible plant\" and \"loss-of-function PIPs,\" finalizing the process through which the Agency determines their eligibility for exemption, and finalizing the associated recordkeeping requirements. This set of exemptions reflects the biotechnological advances made since 2001, when EPA first exempted PIPs derived through conventional breeding and excluded from the exemptions those PIPs that are created through biotechnology. EPA anticipates that today's exemptions will benefit the public by ensuring that human health and the environment are adequately protected, while also reducing the regulatory burden for the regulated community. These exemptions may also result in increased research and development activities, commercialization of new pest control options for farmers, particularly in minor crops, and increase the diversity of options for pest and disease management, which could provide environmental benefits.","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/2023/05/31/2023-11477.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"174","title":40}],"citation":"88 FR 34756","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective on July 31, 2023.","disposition_notes":null,"docket_ids":["EPA-HQ-OPP-2019-0508","FRL-7261-04-OCSPP"],"dockets":[{"supporting_documents":[{"title":"Therapeutic Uses of Some Plant Products","document_id":"EPA-HQ-OPP-2019-0508-0088"},{"title":"Principles of Skin Permeability Relevant to Chemical Exposure","document_id":"EPA-HQ-OPP-2019-0508-0085"},{"title":"OECD Guidelines for the Testing of Chemicals","document_id":"EPA-HQ-OPP-2019-0508-0084"},{"title":"The Seed Industry in U.S. Agriculture: An Exploration of Data and Information on Crop Seed Markets, Regulation, Industry Structure, and Research Development","document_id":"EPA-HQ-OPP-2019-0508-0080"},{"title":"CRISPR/Cas9: A Novel Weapon in the Arsenal to Combat Plant Diseases","document_id":"EPA-HQ-OPP-2019-0508-0075"},{"title":"Evolution of Plant Genome Architecture","document_id":"EPA-HQ-OPP-2019-0508-0065"},{"title":"A Large-Scale Whole-Genome Sequencing Analysis Reveals Highly Specific Genome Editing by Both Cas9 and Cpf1 (Cas12a) Nucleases in Rice","document_id":"EPA-HQ-OPP-2019-0508-0062"},{"title":"Dermal and Inhalation Exposure to Plant Substances","document_id":"EPA-HQ-OPP-2019-0508-0057"},{"title":"Ecogeography of Teosinte","document_id":"EPA-HQ-OPP-2019-0508-0055"},{"title":"Risk Considerations for Outcrossing and Hybridization","document_id":"EPA-HQ-OPP-2019-0508-0053"}],"agency_name":"EPA","documents":[{"comment_count":1,"comment_start_date":"2023-05-31","updated_at":"2023-08-05T01:01:38.336-04:00","comment_url":"https://www.regulations.gov/commenton/EPA-HQ-OPP-2019-0508-0122","allow_late_comments":null,"id":"EPA-HQ-OPP-2019-0508-0122","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":93,"id":"EPA-HQ-OPP-2019-0508","title":"Pesticides; Exemptions of Certain Plant-Incorporated Protectants Derived from Newer Technologies"}],"document_number":"2023-11477","effective_on":"2023-07-31","end_page":34779,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/05/31/2023-11477.xml","html_url":"https://www.federalregister.gov/documents/2023/05/31/2023-11477/pesticides-exemptions-of-certain-plant-incorporated-protectants-pips-derived-from-newer-technologies","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-11477?publication_date=2023-05-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-05-31/2023-11477/mods.xml","not_received_for_publication":null,"page_length":24,"page_views":{"count":1649,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-31/pdf/2023-11477.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-11477.pdf?1685450728","publication_date":"2023-05-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/05/31/2023-11477.txt","regulation_id_number_info":{"2070-AK54":{"issue":"202304","html_url":"https://www.federalregister.gov/regulations/2070-AK54/pesticides-exemptions-of-certain-plant-incorporated-protectants-pips-derived-from-newer-technologies","title":"Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived From Newer Technologies","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=2070-AK54&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["2070-AK54"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Therapeutic Uses of Some Plant Products","document_id":"EPA-HQ-OPP-2019-0508-0088"},{"title":"Principles of Skin Permeability Relevant to Chemical Exposure","document_id":"EPA-HQ-OPP-2019-0508-0085"},{"title":"OECD Guidelines for the Testing of Chemicals","document_id":"EPA-HQ-OPP-2019-0508-0084"},{"title":"The Seed Industry in U.S. Agriculture: An Exploration of Data and Information on Crop Seed Markets, Regulation, Industry Structure, and Research Development","document_id":"EPA-HQ-OPP-2019-0508-0080"},{"title":"CRISPR/Cas9: A Novel Weapon in the Arsenal to Combat Plant Diseases","document_id":"EPA-HQ-OPP-2019-0508-0075"},{"title":"Evolution of Plant Genome Architecture","document_id":"EPA-HQ-OPP-2019-0508-0065"},{"title":"A Large-Scale Whole-Genome Sequencing Analysis Reveals Highly Specific Genome Editing by Both Cas9 and Cpf1 (Cas12a) Nucleases in Rice","document_id":"EPA-HQ-OPP-2019-0508-0062"},{"title":"Dermal and Inhalation Exposure to Plant Substances","document_id":"EPA-HQ-OPP-2019-0508-0057"},{"title":"Ecogeography of Teosinte","document_id":"EPA-HQ-OPP-2019-0508-0055"},{"title":"Risk Considerations for Outcrossing and Hybridization","document_id":"EPA-HQ-OPP-2019-0508-0053"}],"comments_count":1,"agency_id":"EPA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=EPA-HQ-OPP-2019-0508","supporting_documents_count":93,"docket_id":"EPA-HQ-OPP-2019-0508","document_id":"EPA-HQ-OPP-2019-0508-0122","regulation_id_number":null,"title":"Pesticides; Exemptions of Certain Plant-Incorporated Protectants Derived from Newer Technologies","checked_regulationsdotgov_at":"2023-08-06T01:00:07Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":34756,"subtype":null,"title":"Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived From Newer Technologies","toc_doc":"Exemptions of Certain Plant-Incorporated Protectants Derived from Newer Technologies","toc_subject":"Pesticides:\n","topics":["Administrative practice and procedure","Agricultural commodities","Environmental protection","Pesticides and pests","Reporting and recordkeeping requirements"],"type":"Rule","volume":88}