Executive Order 12866 - Regulatory Planning and Review

See § 3(b): "'Agency,' unless otherwise indicated, means . . . an 'agency' . . . other than those considered to be independent regulatory agencies, as defined in 44 U.S.C. 3502(10)." See also §§ 4(b) ("Unified Regulatory Agenda") and 4(c) ("The Regulatory Plan"): "For purposes of this subsection, the term 'agency' or 'agencies' shall also include those considered to be independent regulatory agencies, as defined in 44 U.S.C. 3502(10)."

Regulatory Philosophy and Principles 

The EO sets forth regulatory philosophy and principles to which each agency should adhere. They include requirements to regulate in the “most cost-effective manner,” to make “a reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.”

Unified Regulatory Agenda and Regulatory Plan

Each agency, including independent regulatory agencies as defined in 44 U.S.C. 3502(10), is required to prepare a (semiannual) Agenda of all regulations under development or review; as part of the October Agenda, the agency prepares a Plan of its most important significant regulatory actions.

Review of Existing Regulations

Agencies are required to submit to OIRA a program for periodic review of existing significant regulations to determine whether to modify or eliminate them. Rules to be reviewed must be included in the agency’s Plan. Agencies must also identify legislatively mandated regulations that are unnecessary or outdated.

Public Participation

Before issuing a Noticed of Proposed Rulemaking (NPRM), agencies should seek involvement of those intended to benefit or be burdened. Agencies should provide a meaningful opportunity to comment, including a 60-day comment period in most cases. When appropriate, agencies must use consensual mechanisms.

OIRA Review

Coverage. Agencies, other than independent regulatory agencies, must submit all significant rules and regulatory actions to OIRA for review before publication. There are specified time frames for completion of such review.

Definitions. As used in the executive order, a “rule” or “regulation” means an agency statement of general applicability and future effect that “the agency intends to have the force and effect of law.” A “regulatory action” includes notices of proposed rulemaking, advanced notices of proposed rulemaking, notices of inquiry, and the like.                                         

                                                                                            Changes During OIRA Review. Agencies must identify for the public substantive changes made to the rulemaking documents after submission to OIRA, specifically identifying those “made at the suggestion or recommendation of OIRA.”

Regulatory Analysis

Agencies, other than independent regulatory agencies, are required to prepare an assessment, including analyses, of benefits and costs, quantified to the extent feasible, of the anticipated action and “potentially effective and reasonably feasible alternatives,” including an explanation of why the planned action is preferable.

Risk Analysis

Agencies, other than independent regulatory agencies, are required to “consider, to the extent reasonable, the degree and nature of the risks posed” and “how the agency action will reduce risks to public health, safety, or the environment.”

Resolution of Conflicts

Disagreements among agencies or with OMB that cannot be resolved by OIRA shall be resolved by the President.