{"abstract":"The Environmental Protection Agency (EPA) is proposing regulations that would allow for an exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) for certain PIPs that are created in plants using biotechnology, as long as their pesticidal substances are found in plants that are sexually compatible with the recipient plant and meet the proposed exemption criteria, ensuring their safety. The current exemption for PIPs is limited to PIPs moved through conventional breeding. EPA's proposed rule would allow certain PIPs created through biotechnology to also be exempt under existing regulations, in cases where those PIPs pose no greater risk than PIPs that meet EPA safety requirements, and could have otherwise been created through conventional breeding. The proposed rule also includes a process through which developers of PIPs based on sexually compatible plants created through biotechnology submit either a self-determination letter or request for EPA confirmation that their PIP meets the criteria for exemption. For increased flexibility in bringing PIPs to market, a developer can also submit both. EPA anticipates several benefits that may result from exempting these PIPs. These include lower costs from reduced regulatory burden, increased research, development, and commercialization of pest control options for farmers, particularly in minor crops, and reduced use of conventional pesticides which could provide environmental benefits.","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/2020/10/09/2020-19669.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"174","title":40}],"citation":"85 FR 64308","comment_url":null,"comments_close_on":"2020-12-08","correction_of":null,"corrections":[],"dates":"Comments must be received on or before December 8, 2020.","disposition_notes":null,"docket_ids":["EPA-HQ-OPP-2019-0508","FRL-10014-10"],"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":8120,"comment_start_date":"2020-10-09","updated_at":"2023-02-28T22:42:41.360-05:00","comment_url":"https://www.regulations.gov/commenton/EPA-HQ-OPP-2019-0508-0002","allow_late_comments":null,"id":"EPA-HQ-OPP-2019-0508-0002","comment_end_date":"2020-12-09","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":"2020-19669","effective_on":null,"end_page":64344,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/10/09/2020-19669.xml","html_url":"https://www.federalregister.gov/documents/2020/10/09/2020-19669/pesticides-exemptions-of-certain-plant-incorporated-protectants-pips-derived-from-newer-technologies","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-19669?publication_date=2020-10-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-10-09/2020-19669/mods.xml","not_received_for_publication":null,"page_length":37,"page_views":{"count":2961,"last_updated":"2026-10-23 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-09/pdf/2020-19669.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-19669.pdf?1602161117","publication_date":"2020-10-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/10/09/2020-19669.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":8120,"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-2019-0508-0002","regulation_id_number":null,"title":"Pesticides; Exemptions of Certain Plant-Incorporated Protectants Derived from Newer Technologies","checked_regulationsdotgov_at":"2023-03-01T03:42:40Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":64308,"subtype":null,"title":"Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived From Newer Technologies","toc_doc":"Certain Plant-Incorporated Protectants Derived from Newer Technologies","toc_subject":"Pesticide Tolerance Exemption:\n","topics":["Administrative practice and procedure","Agricultural commodities","Environmental protection","Pesticides and pests","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":85}