0910-AJ04 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Update of FDA Regulations Implementing the Procedural Provisions of the National Environmental Policy Act

This rule will update FDA's existing National Environmental Policy Act (NEPA) regulations under 21 CFR part 25, Environmental Impact Considerations. The updates include removal of references to, and reliance upon, Council on Environmental Quality (CEQ) regulations 21 CFR parts 1500 through 1508; per Executive Order 14154, removal of FDA’s NEPA regulation on environmental effects abroad of major agency actions, 21 CFR 25.60; incorporation of statutory deadlines and page limits for streamlined reviews as mandated in the Fiscal Responsibility Act of 2023 (Public Law 1185); new and updated categorical exclusions that specify classes of actions that ordinarily do not require the preparation of an environmental assessment or environmental impact statement; and new and amended definitions and other conforming changes as warranted to improve clarity and prevent confusion. FDA is taking this action in response to Executive Order 14154, Unleashing American Energy, and the subsequent guidance issued on February 19, 2025, by CEQ entitled "Implementation of NEPA."

]]> Other Significant First Time Published in The Unified Agenda Final Rule Stage No No Deregulatory Not Yet Determined 21 U.S.C. 371(a) 21 U.S.C. 379o 21 U.S.C. 360ccc–1(c)(1)(E) Statutory Final 02/19/2026 Per CEQ February 19, 2025, Memo for Heads of Federal Departments and Agencies Executive Order 14154 directed CEQ to provide guidance to agencies on implementing NEPA and to propose rescinding CEQ's NEPA regulations found at 40 CFR 1500 et seq. No Direct Final Rule 02/00/2026 NPRM - Companion to Direct Final Rule 02/00/2026 No None No No No No Annette McCarthy Lead Biologist, NEPA Specialist 0910 Food and Drug Administration FDA 240 402-1057 annette.mccarthy@fda.hhs.gov Human Foods Program, 5001 Campus Drive, College Park MD 20740