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Required Information for Packages Submitted for CRGR Review

For each proposed action submitted for CRGR review and endorsement, the program office staff shall provide all related documents in electronic format and shall include the following information:

(i)	The new or revised regulatory requirement, generic correspondence, staff position, or regulatory guidance, as the staff proposes to disseminate it to licensees or issue it for public comment. The staff should focus on developing less-prescriptive generic actions that are consistent with the NRC's goal of risk-informed and performance-based regulation. The proposed regulatory requirement, generic correspondence, staff position, or regulatory guidance should specify the desired outcome (objective, performance, or result), rather than prescribing how the licensees should attain that outcome. In so doing, the staff should clearly state the desired outcome, such that it (1) is enforceable, and (2) can be achieved by setting readily quantifiable standards that have an unambiguous relationship to a readily measurable quantity.
(ii)	Draft documents or other materials supporting the new or revised regulatory requirement, generic correspondence, staff position, or regulatory guidance. (A copy of all materials referenced in the document shall be made available upon request to the CRGR staff. In the event a Committee member requests the CRGR staff to obtain a copy of any reference material for his or her use, copies of the said material will be distributed to all members and will also be retained in the CRGR meeting files.)
(iii)	The sponsoring office's position as to whether the proposed regulatory requirement, generic correspondence, staff position, or regulatory guidance would constitute a backfit (that is, whether it would modify, implement, relax existing requirements or staff positions in a manner that would modify or add to systems, structures, or components; the design of a facility; the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct, or operate a facility).

(iv)	The proposed implementation method and resource implications, along with the concurrence (and any comments) of the NRC's Office of the General Counsel (OGC) and all affected offices (including the regional offices), as well as an explanation of any non-concurrences.
(v)	The related regulatory analysis, which generally conforms to the directives and guidance of NUREG/BR-0058 and NUREG/BR-0184, as applicable.1 (This does not apply to backfits that ensure compliance or define/redefine adequate protection. For power reactors, a documented evaluation is required, as discussed under item (ix). For nuclear materials, a similar documented evaluation should be provided as part of the CRGR review package.)
(vi)	The category of power reactors or nuclear materials facilities or activities to which the proposed regulatory requirement, generic correspondence, staff position, or regulatory guidance applies [i.e., whether it applies only to future plants, operating plants, all pressurized-water reactors (PWRs), all boiling-water reactors (BWRs), specific nuclear steam supply system (NSSS) vendors, specific vintage plants, gaseous diffusion plants (GDPs), etc.].

(vii)	A backfit analysis, as defined in the Backfit Rule (10 CFR 50.109 for power reactors or 10 CFR 76.76 for GDPs), unless the proposed action constitutes a compliance or adequate protection backfit.2, 3, 4 The backfit analysis shall document for consideration pertinent available information concerning any of the following factors, as appropriate:
	(a)	statement of the specific objectives that the proposed action is intended to achieve
	(b)	general description of the activity that the licensee or applicant would be required to perform in order to complete the action
	(c)	potential change in the risk to the public from the accidental offsite release of radioactive material
	(d)	potential impact on radiological exposure of facility employees and other onsite workers
	(e)	installation and continuing costs associated with the action, including the cost of facility downtime or the cost of construction delay
	(f)	potential safety impact of changes in plant or operational complexity, including the relationship to proposed and existing regulatory requirements and staff positions
	(g)	estimated resource burden on the NRC associated with the proposed action and the availability of such resources
	(h)	otential impact of differences in facility type, design, or age on the relevancy and practicality of the proposed action
	(i)	whether the proposed action is interim or final, and if interim, the justification for imposing the proposed action on an interim basis
	(j)	staff evaluation of comments received as a result of the notice and comment process (for both rulemaking actions and proposed generic correspondence)
	(k)	an evaluation that demonstrates how the proposed action should be prioritized and scheduled in light of other ongoing regulatory activities (for each category of nuclear power reactor or nuclear materials facility or activity), which may include any or all of the following information, as appropriate:
		1.	proposed priority or schedule
		2.	summary of the current backlog of existing requirements awaiting implementation
		3.	assessment of whether the implementation of existing requirements should be deferred as a result of the proposed action
		4.	any other information that may be considered appropriate with regard to priority, schedule, or cumulative impact (e.g., whether implementation could be delayed pending public comment)
	(l)	any other information that is relevant and material to the proposed action

(viii)	The proposing office director's determination (including the rationale for that determination), based on consideration of the previously listed items (i) through (vii), that the following conditions apply:
	(a)	The proposed action will yield a substantial increase in the overall protection of public health and safety or the common defense and security. 6, 7
	(b)	The direct and indirect costs of implementation for the affected facilities are justified in view of this increased protection.
	This requirement applies to proposed backfits that are analyzed in accordance with 10 CFR 50.109(a)(2), 10 CFR 72.62(c), or 10 CFR 76.76(a)(3) (i.e., other than adequate protection or compliance backfits). As a legal matter, the Backfit Rule (10 CFR 50.109) does not apply to nuclear material facilities and activities that are not licensed under 10 CFR Part 50, although footnote 6 does apply to evaluations of proposed backfit actions that affect the selected nuclear facilities and activities. Nonetheless, the staff should consider specific provisions of 10 CFR 72.62 and 10 CFR 76.76, as appropriate, when considering backfit-related matters for independent spent fuel storage installations (ISFSI) and the monitored retrievable storage installations (GDPs), respectively. Additionally, in the context of licensing actions under 10 CFR Part 70, the Commission supported the requirement that "…any new backfit [must] pass a cost-benefit test without the 'substantial increase in safety' test. The Commission believes that modest increases in safety at minimal or inconsequential cost should be justified on a cost-benefit basis."8


(ix)	For adequate protection or compliance backfits affecting power reactors, evaluated pursuant to 10 CFR 50.109(a)(4) (or analogous provisions in 10 CFR 72.62 or 10 CFR 76.76, as appropriate), the package submitted for CRGR review and endorsement must include the following:
	(a)	a documented evaluation, including of the following information:
		(1)	objectives of the modification
		(2)	reasons for the modification
		(3)	basis for compliance exception (if applicable), including the following
			(A)	requirements (e.g., Commission regulation, license condition, order) or written licensee commitments, for which compliance is sought
			(B)	assessment of risk/safety implications of not requiring licensees to immediately restore compliance, and the basis for determining that a reasonable concession could be allowed to defer restoration of compliance at a later time (e.g., next refueling outage)
			(C)	demonstrated consideration of other possible alternatives, and rationale for rejecting them in favor of compliance backfitting
			(D)	evaluation of cost-benefit considerations (not a full-blown regulatory analysis) and the rationale for the proposed compliance exception
		(4)	basis for concluding that the matter to be addressed involves adequate protection (if the adequate protection exception is invoked), and why current requirements (e.g., regulations, license conditions, and/or orders) or written licensee commitments do not provide adequate protection
	(b)	an evaluation documenting the safety-significance and appropriateness of the action taken (for actions that were immediately effective and, therefore, issued without prior CRGR review, as discussed in Section III of the CRGR Charter), and consideration of how costs contributed to selecting the solution from various acceptable alternatives (if applicable).

(x)	For each request for information from power reactor licensees under 10 CFR 50.54(f), which is for purposes other than to verify compliance with the facility's licensing basis, the package submitted for CRGR review and endorsement must contain an evaluation that includes at least the following elements:
	(a)	problem statement that describes the need for the information in terms of the potential safety benefit
	(b)	required licensee actions and anticipated cost to develop a response to the information request
	(c)	anticipated schedule for NRC use of the information
	(d)	*statement affirming that the request does not* impose new requirements on the licensee**, other than submittal of the requested the information
	(e)	proposing office director's determination that the burden to be imposed on the respondents is justified in view of the potential safety-significance of the issue to be addressed in the requested information
	Under the provisions of 10 CFR 50.54(f), unless the request for information is for the purpose of verifying compliance with a facility's licensing basis, the NRC's Executive Director for Operations (EDO) shall approve the staff's justification. Additional guidance for preparing this evaluation is provided in Section 5.4 of NUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission."9 The package submitted for CRGR review and endorsement should include an analogous evaluation addressing the previously listed items (a) through (e) for each request for information that is directed to licensees of the selected nuclear materials facilities or activities referred to in Section III of the CRGR Charter.
(xi)	For each proposed power reactor backfit that is analyzed pursuant to 10 CFR 50.109(a)(2) (i.e., other than adequate protection or compliance backfits), the package submitted for CRGR review and endorsement should include an assessment of how the proposed action relates to the Commission's Safety Goal Policy Statement.9

1.	Reference Revision 4 of NUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission," dated September 2004, and NUREG/BR-0184, "Regulatory Analysis Technical Evaluation Handbook," dated January 1997.
2.	As a legal matter, the Backfit Rule (10 CFR 50.109) does not strictly apply unless a backfit is required, for example, by a rule or order. However, the NRC's backfit process (including the responsibilities established by the CRGR Charter) is defined on the principle that new regulatory requirements and staff positions are to be reviewed for backfitting considerations and, if appropriate, must meet the standards of the Backfit Rule before being issued to licensees. New generic positions in generic letters, bulletins, regulatory guides, and other documents are to be considered and justified as backfits before they are issued (regardless of whether they affect power reactors or nuclear materials facilities and activities).
3.	Types of actions that are exempt from the standards of the Backfit Rule (10 CFR 50.109) include (a) voluntary actions, (b) actions mandated by statute, and {c) requests for information. (For further discussion, see Section 2.1.1 of NUREG-1409, "Backfitting Guidelines," dated July 1990.)
4.	Reporting requirements, such as those contained in 10 CFR 50.72 and 10 CFR 50.73 (for power reactors), or 10 CFR 70.50 and 10 CFR 70.52 (for nuclear materials activities), are more akin to the information requests covered under 10 CFR 50.54(f) than they are to modifications covered under the Backfit Rule (10 CFR 50.109). Consequently, such reporting requirements should be justified by an evaluation against criteria similar to the analogous provision in 10 CFR 50.54(f) (i.e., by demonstrating that the burden of reporting is justified in view of the potential safety benefits to be obtained from the information reported).
5.	Generic communications that state a new staff position or seek additional licensee commitments affecting power reactors are generally issued for public comment through a Federal Register notice. The Commission's instructions in this regard are documented in the following staff requirements memoranda: Memorandum from S.J. Chilk to J.M. Taylor, dated October 27, 1992, regarding SECY-92-338, "Implementing Procedures for Issuing Urgent Generic Communications" Memorandum from S.J. Chilk to J.M. Taylor, dated July 17, 1992, regarding SECY-92-224, "Revised Implementing Procedures for Issuance of Generic Communications" Memorandum from S.J. Chilk to J.M. Taylor, dated December 20, 1991, regarding SECY-91-172, "Regulatory Impact Survey"
6.	Appendix D to the CRGR Charter provides additional guidance regarding consideration of qualitative factors in applying the "substantial increase" standard of 10 CFR 50.59 for actions affecting power reactors. By definition, the Backfit Rule (10 CFR 50.109) does not apply to nuclear material facilities and activities that are not licensed under 10 CFR Part 50; however, in evaluating qualitative factors that may contribute to the justification of proposed backfitting actions that are applicable to nuclear material facilities and activities, the staff should consider the applicable guidance in Appendix D to the CRGR Charter, in conjunction with other Commission directives.
7.	Certain proposed actions that affect power reactors may not meet the "substantial increase" standard of 10 CFR 50.59, but, in the staff's judgment, should be promulgated nonetheless. The Commission has indicated its willingness to consider such exceptions to the Backfit Rule on a case-by-case basis; however, such exceptions will be promulgated only if the staff's proposal (not to apply the Backfit Rule to the proposed rulemaking) is issued for public comment as the subject of a Federal Register notice.
8.	See the Staff Requirements Memorandum regarding SECY-98-085, "Proposed Rulemaking: Revised Requirements for the Domestic Licensing of Special Nuclear Material," dated December 1, 1998.
9.	Detailed guidance for addressing the Commission's safety goals is contained in Revision 4 of NUREG/BR-0058, "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission," dated September 2004.

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Page Last Reviewed/Updated Tuesday, April 13, 2021