Rulemaking

10 C.F.R. Part ..., Subpart H
in effectEffective: 2024-07-01

10 C.F.R. § 2.800 Scope and applicability.

(a) This subpart governs the issuance, amendment, and repeal of regulations in which participation by interested persons is prescribed under Section 553 of title 5 of the U.S. Code. (b) The procedures in §§ 2.804 through 2.810 apply to all rulemakings. (c) The procedures in §§ 2.802 through 2.803 apply to all petitions for rulemaking except for initial applications for standard design certification rulemaking under subpart B of part 52 of this chapter, and subsequent petitions for amendment of an existing design certification rule filed by the original applicant for the design certification rule. (d) The procedures in §§ 2.811 through 2.819, as supplemented by the provisions of subpart B of part 52, apply to standard design certification rulemaking.

10 C.F.R. § 2.801 Initiation of rulemaking.

Rulemaking may be initiated by the Commission at its own instance, on the recommendation of another agency of the United States, or on the petition of any other interested person, including an application for design certification under subpart B of part 52 of this chapter.

10 C.F.R. § 2.802 Petition for rulemaking—requirements for filing.

(a) Filing a petition for rulemaking. Any person may petition the Commission to issue, amend, or rescind any regulation in 10 CFR chapter I. The petition for rulemaking should be addressed to the Secretary, Attention: Rulemakings and Adjudications Staff, and sent by mail addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by email to Rulemaking. Comments@nrc.gov; or by hand delivery to 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern time) on Federal workdays. (b) Consultation with the NRC. A petitioner may consult with the NRC staff before and after filing a petition for rulemaking by contacting the Chief, Regulatory Analysis and Rulemaking Support Branch, Division of Rulemaking, Environmental, and Financial Support, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 1-800-368-5642. (1) In any consultation regarding the drafting or amendment of a petition for rulemaking, the assistance that the NRC staff may provide is limited to the following: (i) Describing the process for filing, docketing, tracking, closing, amending, withdrawing, and resolving a petition for rulemaking; (ii) Clarifying an existing NRC regulation and the basis for the regulation; and (iii) Assisting the petitioner to clarify a petition for rulemaking so that the Commission is able to understand the issues of concern to the petitioner. (2) In any consultation regarding the drafting or amendment of a petition for rulemaking, in providing the assistance permitted in paragraph (b)(1) of this section, the NRC staff will not draft or develop text or alternative approaches to address matters in the petition for rulemaking. (3) In any consultation regarding a petition for rulemaking, the NRC staff will not advise a petitioner on whether a petition should be amended or withdrawn. (c) Content of petition. (1) Each petition for rulemaking filed under this section must clearly and concisely: (i) Specify the name of the petitioner, a telephone number, a mailing address, and an email address (if available) that the NRC may use to communicate with the petitioner; (ii) If the petitioner is an organization, provide additional identifying information (as applicable) including the petitioner's organizational or corporate status, the petitioner's State of incorporation, the petitioner's registered agent, and the name and authority of the individual who signed the petition on behalf of the organizational or corporate petitioner. (iii) Present the specific problems or issues that the petitioner believes should be addressed through rulemaking, including any specific circumstances in which the NRC's codified requirements are incorrect, incomplete, inadequate, or unnecessarily burdensome; (iv) Cite, enclose, or reference publicly-available technical, scientific, or other data or information supporting the petitioner's assertion of the problems or issues; (v) Present the petitioner's proposed solution to the problems or issues raised in the petition for rulemaking (e.g., a proposed solution may include specific regulations or regulatory language to add to, amend in, or delete from 10 CFR chapter I); (vi) Provide an analysis, discussion, or argument that explains how the petitioner's proposed solution solves the problems or issues identified by the petitioner; and (vii) Cite, enclose, or reference any other publicly-available data or information supporting the petitioner's proposed solution; and (viii) If required by 10 CFR 51.68 of this chapter, submit a separate document entitled “Petitioner's Environmental Report,” which contains the information specified in 10 CFR 51.45. (2) To assist the NRC in its evaluation of the petition for rulemaking, the petitioner should clearly and concisely: (i) Explain why the proposed rulemaking solution is within the authority of the NRC to adopt; and (ii) Explain why rulemaking is the most favorable approach to address the problem or issue, as opposed to other NRC actions such as licensing, issuance of an order, or referral to another Federal or State agency. (3) If the petition is signed by multiple petitioners, the petition must designate a lead petitioner who is responsible for disseminating communications received from the NRC to co-petitioners. (d) [Reserved] (e) Request for suspension of an adjudication involving licensing. The petitioner may request the Commission to suspend all or any part of any licensing proceeding to which the petitioner is a participant pending disposition of the petition for rulemaking. (f) Amendment; withdrawal. If the petitioner wants to amend or withdraw a docketed petition for rulemaking, then the petitioner should include the docket number and the date that the original petition for rulemaking was submitted in a filing addressed to the Secretary, Attention: Rulemakings and Adjudications Staff, and sent by mail addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; or by email to Rulemaking. Comments@nrc.gov.

10 C.F.R. § 2.803 Petition for rulemaking—NRC action.

(a) Notification of receipt. Following receipt of a petition for rulemaking, the NRC will acknowledge its receipt to the petitioner. (b) Docketing review. (1) The NRC will evaluate the petition for rulemaking, including supporting data or information submitted under § 2.802(c), for sufficiency according to the review criteria in § 2.803(b). (2) If the NRC determines that the petition for rulemaking does not include the information set out in § 2.802(c), that the regulatory change sought by the petitioner is not within the legal authority of the NRC, or that the petition for rulemaking does not raise a potentially valid issue that warrants further consideration, then the NRC will notify the petitioner in writing and explain the deficiencies in the petition for rulemaking. (3) The petitioner may resubmit the petition for rulemaking without prejudice. (c) Docketing. (1) The NRC will docket a petition for rulemaking and assign a docket number to the petition if the NRC determines the following: (i) The petition for rulemaking includes the information required by paragraph § 2.802(c), (ii) The regulatory change sought by the petitioner is within the NRC's legal authority, and (iii) The petition for rulemaking raises a potentially valid issue that warrants further consideration. (2) A copy of the docketed petition for rulemaking will be posted in the NRC's Agencywide Documents Access and Management System (ADAMS) and on the Federal rulemaking Web site at: http://www.regulations.gov. The NRC will publish a notice of docketing in the Federal Register informing the public that the NRC is reviewing the merits of the petition for rulemaking. The notice of docketing will include the docket number and explain how the public may track the status of the petition for rulemaking. (d) NRC communication with petitioners. If the petition is signed by multiple petitioners, any NRC obligation to inform a petitioner (as may be required under 10 CFR part 2, subpart H) is satisfied, with respect to all petitioners, when the NRC transmits the required notification to the lead petitioner. (e)-(f) [Reserved] (g) Public comment on a petition for rulemaking; hearings. (1) At its discretion, the NRC may request public comment on a docketed petition for rulemaking. (2) The NRC will post all comment submissions at http://www.regulations.gov and enter the comment submissions into ADAMS, without removing identifying or contact information from comment submissions. Anyone requesting or aggregating comments from other persons for submission to the NRC is responsible for informing those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submissions. (3) No adjudicatory or legislative hearing under the procedures of 10 CFR part 2 will be held on a petition for rulemaking unless the Commission determines to do so, at its discretion. (h) Determination on a petition for rulemaking; Closure of docket on a petition for rulemaking (1)—Determination. Following docketing of a petition for rulemaking, the NRC's determination on the petition for rulemaking may be based upon, but is not limited to, the following considerations: (i) The merits of the petition; (ii) The immediacy of the safety, environmental, or security concern raised; (iii) The availability of NRC resources and the priority of the issues raised in relation to other NRC rulemaking issues; (iv) Whether the problems or issues are already under consideration by the NRC in other NRC processes; (v) The substance of any public comment received, if comment is requested; and (vi) The NRC's relevant past decisions and current policies. (2) Petition for rulemaking docket closure. After the NRC determines the appropriate regulatory action in response to the petition for rulemaking, the NRC will administratively close the docket for the petition. The NRC will publish a notice describing that action with any related Docket Identification number (Docket ID), as applicable, in the Federal Register. The NRC may make a determination on a petition for rulemaking and administratively close the docket for the petition for rulemaking by: (i) Deciding not to undertake a rulemaking to address the issue raised by the petition for rulemaking, and informing the petitioner in writing of the grounds for denial. (ii) Initiating a rulemaking action (e.g., initiating a new rulemaking, addressing the petition for rulemaking in an ongoing rulemaking, addressing the petition for rulemaking in a planned rulemaking) that considers the issues raised by a petition for rulemaking, and informing the petitioner in writing of this decision and the associated Docket ID of the rulemaking action, if applicable. (i) Petition for rulemaking resolution—(1) Petition for rulemaking resolution published in the Federal Register. The NRC will publish a Federal Register notice informing the public that it has concluded all planned regulatory action with respect to some or all of the issues presented in a petition for rulemaking. This may occur by adoption of a final rule related to the petition for rulemaking, denial by the NRC of the petition for rulemaking at any stage of the regulatory process, or the petitioner's withdrawal of the petition for rulemaking before the NRC has entered the rulemaking process. As applicable, the Federal Register notice will include a discussion of how the regulatory action addresses the issue raised by the petitioner, the NRC's grounds for denial of the petition for rulemaking, or information on the withdrawal. The notice will normally include the NRC's response to any public comment received (if comment is requested), unless the NRC has indicated that it will not be providing a formal written response to each comment received. (2) NRC decision not to proceed with rulemaking after closure of a petition for rulemaking docket. If the NRC closes a petition for rulemaking docket under paragraph (h)(2)(ii) of this section but subsequently decides not to carry out the planned rulemaking to publication of a final rule, the NRC will notify the petitioner in writing of this decision and publish a notice in the Federal Register explaining the basis for its decision. The decision not to complete the rulemaking action will be documented as denial of the petition for rulemaking in the docket of the closed petition for rulemaking, in the Web sites, in the Government-wide Unified Agenda of Federal Regulatory and Deregulatory Actions, online in ADAMS, and at http://www.regulations.gov as described in paragraph (j) of this section. (j) Status of petitions for rulemaking and rulemakings. (1) The NRC provides current information on rulemakings and petitions for rulemaking in the NRC Library at http://www.nrc.gov/about-nrc/regulatory/rulemaking.html. (2) The NRC includes a summary of the NRC's planned and ongoing rulemakings in the Government-wide Unified Agenda of Federal Regulatory and Deregulatory Actions (the Unified Agenda), published semiannually. This Unified Agenda is available at http://www.reginfo.gov/public/do/eAgendaMain/. (3) All docketed petitions, rulemakings, and public comments are posted online in ADAMS and at http://www.regulations.gov.

10 C.F.R. § 2.804 Notice of proposed rulemaking.

(a) Except as provided by paragraph (d) of this section, when the Commission proposes to adopt, amend, or repeal a regulation, it will cause to be published in the Federal Register a notice of proposed rulemaking, unless all persons subject to the notice are named and either are personally served or otherwise have actual notice in accordance with law. (b) The notice will include: (1) Either the terms or substance of the proposed rule, or a specification of the subjects and issues involved; (2) The manner and time within which interested members of the public may comment, and a statement that copies of comments may be examined will be made available at the NRC Web site, http://www.nrc.gov; (3) The authority under which the regulation is proposed; (4) The time, place, and nature of the public hearing, if any; (5) If a hearing is to be held, designation of the presiding officer and any special directions for the conduct of the hearing; and (6) Such explanatory statement as the Commission may consider appropriate. (c) The publication or service of notice will be made not less than fifteen (15) days prior to the time fixed for hearing, if any, unless the Commission for good cause stated in the notice provides otherwise. (d) The notice and comment provisions contained in paragraphs (a), (b), and (c) of this section will not be required to be applied— (1) To interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or (2) When the Commission for good cause finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest, and are not required by statute. This finding, and the reasons therefor, will be incorporated into any rule issued without notice and comment for good cause. (e) The Commission shall provide for a 30-day post-promulgation comment period for— (1) Any rule adopted without notice and comment under the good cause exception on paragraph (d)(2) of this section where the basis is that notice and comment is “impracticable” or “contrary to the public interest.” (2) Any interpretative rule, or general statement of policy adopted without notice and comment under paragraph (d)(1) of this section, except for those cases for which the Commission finds that such procedures would serve no public interest, or would be so burdensome as to outweigh any foreseeable gain. (f) For any post-promulgation comments received under paragraph (e) of this section, the Commission shall publish a statement in the Federal Register containing an evaluation of the significant comments and any revisions of the rule or policy statement made as a result of the comments and their evaluation.

10 C.F.R. § 2.805 Participation by interested persons.

(a) In all rulemaking proceedings conducted under the provisions of § 2.804(a), the Commission will afford interested persons an opportunity to participate through the submission of statements, information, opinions, and arguments in the manner stated in the notice. The Commission may grant additional reasonable opportunity for the submission of comments. (b) The Commission may hold informal hearings at which interested persons may be heard, adopting procedures which in its judgment will best serve the purpose of the hearing.

10 C.F.R. § 2.806 Commission action.

The Commission will incorporate in the notice of adoption of a regulation a concise general statement of its basis and purpose, and will cause the notice and regulation to be published in the Federal Register or served upon affected persons.

10 C.F.R. § 2.807 Effective date.

The notice of adoption of a regulation will specify the effective date. Publication or service of the notice and regulation, other than one granting or recognizing exemptions or relieving from restrictions, will be made not less than thirty (30) days prior to the effective date unless the Commission directs otherwise on good cause found and published in the notice of rule making.

10 C.F.R. § 2.808 Authority of the Secretary to rule on procedural matters.

When briefs, motions or other documents listed herein are submitted to the Commission itself, as opposed to officers who have been delegated authority to act for the Commission, the Secretary or the Assistant Secretary is authorized to: (a) Prescribe schedules for the filing of statements, information, briefs, motions, responses or other pleadings, where such schedules may differ from those elsewhere prescribed in these rules or where these rules do not prescribe a schedule; (b) Rule on motions for extensions of time; (c) Reject motions, briefs, pleadings, and other documents filed with the Commission later than the time prescribed by the Secretary or the Assistant Secretary or established by an order, rule, or regulation of the Commission unless good cause is shown for the late filing; and (d) Prescribe all procedural arrangements relating to any oral argument to be held before the Commission.

10 C.F.R. § 2.809 Participation by the Advisory Committee on Reactor Safeguards.

(a) In its advisory capacity to the Commission, the ACRS may recommend that the Commission initiate rulemaking in a particular area. The Commission will respond to such rulemaking recommendation in writing within 90 days, noting its intent to implement, study, or defer action on the recommendation. In the event the Commission decides not to accept or decides to defer action on the recommendation, it will give its reasons for doing so. Both the ACRS recommendation and the Commission's response will be made available at the NRC Web site, http://www.nrc.gov, following transmittal of the Commission's response to the ACRS. (b) When a rule involving nuclear safety matters within the purview of the ACRS is under development by the NRC Staff, the Staff will ensure that the ACRS is given an opportunity to provide advice at appropriate stages and to identify issues to be considered during rulemaking hearings.

10 C.F.R. § 2.810 NRC size standards.

The NRC shall use the size standards contained in this section to determine whether a licensee qualifies as a small entity in its regulatory programs. (a) A small business is a for-profit concern and is a— (1) Concern that provides a service or a concern not engaged in manufacturing with average gross receipts of $8.0 million or less over its last 5 completed fiscal years; or (2) Manufacturing concern with an average number of 500 or fewer employees based upon employment during each pay period for the preceding 12 calendar months. (b) A small organization is a not-for-profit organization which is independently owned and operated and has annual gross receipts of $8.0 million or less. (c) A small governmental jurisdiction is a government of a city, county, town, township, village, school district, or special district with a population of less than 50,000. (d) A small educational institution is one that is— (1) Supported by a qualifying small governmental jurisdiction; or (2) Not state or publicly supported and has 500 or fewer employees. (e) For the purposes of this section, the NRC shall use the Small Business Administration definition of receipts (13 CFR 121.104). A licensee who is a subsidiary of a large entity does not qualify as a small entity for purposes of this section. (f) Whenever appropriate in the interest of administering statutes and regulations within its jurisdiction, it is the practice of the NRC to answer inquiries from small entities concerning information on and advice about compliance with the statutes and regulations that affect them. To help small entities obtain information quickly, the NRC has established a toll-free telephone number at 1-800-368-5642.

10 C.F.R. § 2.811 Filing of standard design certification application; required copies.

(a) Serving of applications. The signed original of an application for a standard design certification, including all amendments to the applications, must be sent either by mail addressed: ATTN: Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by facsimile; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland, between the hours of 7:30 a.m. and 4:15 p.m. eastern time; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, e-mail, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information. If the communication is on paper, the signed original must be sent. (b) Form of application. Each original of an application and an amendment of an application must meet the requirements in § 2.813. (c) Capability to provide additional copies. The applicant shall maintain the capability to generate additional copies of the general information and the safety analysis report, or part thereof or amendment thereto, for subsequent distribution in accordance with the written instructions of the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as appropriate. (d) Public hearing copy. In any hearing conducted under subpart O of this part for a design certification rulemaking, the applicant must make a copy of the updated application available at the public hearing for the use of any other parties to the proceeding, and shall certify that the updated copies of the application contain the current contents of the application submitted in accordance with the requirements of this part. (e) Pre-application consultation. A prospective applicant for a standard design certification may consult with NRC staff before filing an application by writing to the Director, Division of New and Renewed Licenses, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, with respect to the subject matters listed in § 2.802(b)(1). A prospective applicant also may telephone the Regulatory Analysis and Rulemaking Support Branch, Division of Rulemaking, Environmental, and Financial Support, Office of Nuclear Material Safety and Safeguards, toll free on 1-800-368-5642 on these subject matters. In addition, a prospective applicant may confer informally with NRC staff before filing an application for a standard design certification, and the limitations on consultation in § 2.802(b)(2) do not apply.

10 C.F.R. § 2.813 Written communications.

(a) General requirements. All correspondence, reports, and other written communications from the applicant to the Nuclear Regulatory Commission concerning the regulations in this subpart, and parts 50, 52, and 100 of this chapter must be sent either by mail addressed: ATTN: Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland, between the hours of 7:30 a.m. and 4:15 p.m. eastern time; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, e-mail, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information. If the communication is on paper, the signed original must be sent. If a submission due date falls on a Saturday, Sunday, or Federal holiday, the next Federal working day becomes the official due date. (b) Form of communications. All paper copies submitted to meet the requirements set forth in paragraph (a) of this section must be typewritten, printed or otherwise reproduced in permanent form on unglazed paper. Exceptions to these requirements imposed on paper submissions may be granted for the submission of micrographic, photographic, or similar forms. (c) Regulation governing submission. An applicant submitting correspondence, reports, and other written communications under the regulations of this chapter is requested but not required to cite whenever practical, in the upper right corner of the first page of the submission, the specific regulation or other basis requiring submission.

10 C.F.R. § 2.815 Docketing and acceptance review.

(a) Each application for a standard design certification will be assigned a docket number. However, to allow a determination as to whether an application is complete and acceptable for docketing, it will be initially treated as a tendered application. A copy of the tendered application will be available for public inspection at the NRC Web site, http://www.nrc.gov, and/or at the NRC Public Document Room. Generally, the determination on acceptability for docketing will be made within a period of 30 days. The Commission may decide to determine acceptability on the basis of the technical adequacy of the application as well as its completeness. (b) If the Commission determines that a tendered application is complete and acceptable for docketing, a docket number will be assigned to the application or part thereof, and the applicant will be notified of the determination.

10 C.F.R. § 2.817 Withdrawal of application.

(a) The Commission may permit an applicant to withdraw an application for a standard design certification before the issuance of a notice of proposed rulemaking on such terms and conditions as the Commission may prescribe, or may, on receiving a request for withdrawal of an application, deny the application or dismiss it without prejudice. The NRC will publish in the Federal Register a document withdrawing the application, if the notice of receipt of the application, an advance notice of proposed rulemaking, or a notice of proposed rulemaking for the standard design certification has been previously published in the Federal Register. If the notice of receipt, advance notice of proposed rulemaking or notice of proposed rulemaking was published on the NRC Web site, then the notice of action on the withdrawal will also be published on the NRC Web site. (b) The withdrawal of an application does not authorize the removal of any document from the files of the Commission.

10 C.F.R. § 2.819 Denial of application for failure to supply information.

(a) The Commission may deny an application for a standard design certification if an applicant fails to respond to a request for additional information within 30 days from the date of the request, or within such other time as may be specified. (b) If the Commission denies an application because the applicant has failed to respond in a timely fashion to a request for additional information, the NRC will publish in the Federal Register a notice of denial and will notify the applicant with a simple statement of the grounds of denial. If a notice of receipt of application, advance notice of proposed rulemaking, or notice of proposed rulemaking for a standard design certification was published on the NRC Web site, then the notice of action on the denial will also be published on the NRC Web site.

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