Direct Final Rule

On this page:

• Background
• Direct Final Rule Procedures
• Criteria for Determining a Significant Adverse Comment

Background

A direct final rule is a regulatory document that is used for non-controversial regulatory amendments.  The direct final rule process allows an agency to issue a rule without having to go through the review process twice (i.e., at the proposed and final rule stages), while at the same time offering the public the opportunity to challenge the agency's view that the rule is non-controversial. 

The former Administrative Conference of the United States (ACUS) endorsed use of the direct final rule process as a means for expediting rulemaking (see ACUS Recommendation 95-4, Procedures for Non-controversial and Expedited Rulemaking (60 FR 43110; August 18, 1995)).  Although not explicitly sanctioned by the Administrative Procedure Act (APA), this process complies with the APA under two rationales:

• The process comes within the meaning of the good cause exemption of Section 553(b)(B) for bypassing the usual notice-and-comment requirements when public participation is unnecessary; i.e., the rule is non-controversial and unlikely to attract public comment.
• The process includes the essential elements of rulemaking required by the APA – notice and opportunity for comment, a statement of basis and purpose, and publication of the rule not less than 30 days prior to its effective date – although these elements are not achieved exactly in the manner envisioned in the APA.

Two types of NRC rulemakings that typically use the direct final rule process are the issuance of (or amendment to) a Certificate of Compliance listing in 10 CFR 72.214 and rules requiring the use of updated NRC Forms.

Direct Final Rule Procedures

The NRC publishes a direct final rule and a companion proposed rule concurrently in the Federal Register.  The direct final rule will contain language that states that any significant adverse comments received will be considered as comments on the companion proposed rule and that, absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a separate comment period for the action.

An NRC direct final rule becomes effective in a certain number of days, usually 75 days after publication, unless the NRC receives significant adverse comments within a prescribed comment period, usually 30 days after publication.  The 45-day period between the close of the public comment period and the effective date of the direct final rule is provided to allow the NRC sufficient time to evaluate whether any of the comments received are significant adverse comments and, if so, to prepare and publish a withdrawal of the direct final rule.

If no public comments are received, the NRC publishes a subsequent document that confirms the effective date.  The direct final rule becomes effective on the date stated in the direct final rule or at least 30 days after the publication date of the confirmation document, whichever is later, unless the direct final rule grants or recognizes an exemption or relieves a restriction, in which case it becomes effective on the date specified in the direct final rule.

If public comments are received but they are not significant adverse comments, the NRC publishes a similar confirmation document.  In this document the NRC may, in special circumstances, choose to explain why the comments received were not considered to be significant adverse comments in order to achieve added transparency to its determinations.

If significant adverse comments are received, the NRC publishes a document in the Federal Register that withdraws the direct final rule in whole or in part before the specified effective date.  If the NRC desires to proceed with the rulemaking, it prepares and publishes a subsequent final rule that addresses the comments received on the companion proposed rule that was published concurrently with the direct final rule.

A direct final rule complies with all the legal and procedural requirements applicable to a final rule, including:  National Technology Transfer and Advancement Act, National Environmental Policy Act, Paperwork Reduction Act, Regulatory Analysis, Regulatory Flexibility Act, Backfit analysis, and Congressional Review Act. 

Criteria for Determining a Significant Adverse Comment

The NRC's definition of a significant adverse comment is taken from ACUS Recommendation 95-4.  A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change.  A comment is adverse and significant if:

• The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process.  For example, a substantive response is required when:
• The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;
• The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or
• The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.
• The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.
• The comment causes the NRC staff to make a change (other than editorial) to the rule.