The NRC Staff's Topical Report Role
Office Instruction LIC-500, describes the role of the NRC staff in the topical report process. There are seven phases in the NRC staff topical review process which are discussed in detail in LIC-500. The phases, as summarized on this page, are:
A flowchart showing the seven phases and steps in a topical report review is shown in the figure.
Select figure to enlarge.
Phase 1: Submittal
Much of this phase is focused on those activities which occur before the submittal of the topical report, namely any pre-submittal meetings. While these meeting are optional, most organizations choose to at least one pre-submittal meeting for the efficiencies that is added to the process. These meetings can be a valuable tool in obtaining staff feedback or helping the staff determine the topical report priority. This phase ends when the TR has been submitted to the NRC and is placed on the docket.
Phase 2: Planning and Priority
This phase begins once the topical report has been submitted for NRC staff review and ends when the priority has been determined. Most of the steps in this phase are focused on planning the review schedule and determining the priority of the review. The planning and scheduling is done among the Project Manager and all technical reviewers assigned to the topical report evaluation.
Priority is assigned for the topical report against other agency work as well as among the different topical reports under NRC staff review with the same subject matter.
Phase 3: Completeness and Decision Letter
The beginning of this phase is based on the priority of the topical report and it starts when the NRC staff is scheduled to begin the technical review. This phase determines if the topical report is technically complete enough to allow for an NRC staff review. It also means that all proprietary and non-proprietary information has been appropriately marked. The phase ends with the issuance of the decision letter.
Phase 4: Preliminary Safety Evaluation with Open Items
Phase 4 marks the true start of the technical review. It beings if the topical report has been accepted for review and after the decision letter is issued. It ends when the RAIs have been emailed to the submitter by the Project Manager. The primary goal of this phase is the generation of the preliminary safety evaluation (i.e., a safety evaluation with open items that is not issued but used to generate RAIs).
In this phase, the NRC staff will conduct its detailed, technical review and create the preliminary safety evaluation. The preliminary safety evaluation is an internal document that is written as if all necessary information were provided for the NRC staff to make a determination on the acceptability of the topical report for use.
Any gaps in the preliminary safety evaluation will be used by the NRC staff to identify areas where RAIs are needed. These RAIs then identify those pieces of essential information that are needed to complete the draft safety evaluation.
After the RAIs have been issued, the NRC staff and submitting organization may hold conference calls to clarify either the RAIs or the intended responses. Usually these calls do not need to be publically noticed. However, if the calls are focused on discussing technical information that is more detailed than just clarification, then the calls should be noticed, and if appropriate depending on the proprietary nature of the information, allow for stakeholder involvement.
Submitting organizations must provide responses to RAIs via a formal transmittal. The response should include the original RAIs and responses to ensure that both will then be placed into ADAMS and a nonproprietary version made available for stakeholder access.
If proprietary information in the RAI responses is covered by the original affidavit, the response letter should state that. If new proprietary information is provided, another affidavit is needed and the NRC staff must make its findings under 10 CFR 2.390.
Phase 5: Draft Safety Evaluation
This phase begins after the RAIs responses have been received and ends when all of the open items in the preliminary safety evaluation are closed. Then the preliminary safety evaluation becomes the draft safety evaluation which is formally transmitted to the submitting organization.
The draft safety evaluation is provided to identify any proprietary information and to clarify any factual inaccuracies, or potential misunderstandings. Twenty days, or another negotiated response time, are allowed for the submitter to respond to the draft safety evaluation. The NRC staff is willing to engage on questions concerning clarifications in the draft safety evaluation but will not entertain technical arguments for changing the conclusions reached unless new information not already available during the review is formally submitted. Any technical arguments for changing the findings in the draft SE will necessarily require a change in the schedule and/or priority of the topical report, including time to receive new information, revise the preliminary safety evaluation, develop RAIs, and complete the draft safety evaluation.
Phase 6: Final Safety Evaluation
Once the NRC staff has addressed any comments or questions related to (1) clarifications, (2) inaccuracies, (3) proprietary language, and (4) conditions and limitations, it will issue the final safety evaluation. Both a proprietary and nonproprietary version of the safety evaluation will be issued under separate transmittal letter.
Phase 7: "-A" Version
This is the final phase of the process and occurs if the NRC staff has found the topical report acceptable for use. It begins after the final safety evaluation has been placed on the docket and transmitted to the submitting organization. Once the final safety evaluation is issued, the submitting organization has 60 days, or any other negotiated time, to provide the "-A" version. It ends once the "-A" verification letter is issued by the NRC staff.
During this phase, the NRC will determine if the topical report is considered a rule under the Congressional Review Act (CRA). If it is, the NRC will consult with the Office of Management and Budget (OMB) as required under the CRA to determine if the topical report is considered a major rule.
Part of the information the NRC staff provides to OMB is the anticipated costs of using the topical report. In preparing that portion of the OMB information, the NRC staff may consult with the submitting organization to obtain detailed costs information for using the topical report.
If the NRC staff verifies that the "-A" version of the topical report does not change any of the SE conclusions, and OMB determines it is not a major rule, the NRC staff will issue its verification letter. If OMB determines the topical report is a major rule, then further consultation will be needed.
Page Last Reviewed/Updated Tuesday, July 07, 2020