Governing Regulations and Requirements for Topical Reports
A topical report allows for a single review and (if appropriate) approval, by the U.S. Nuclear Regulatory Commission (NRC), of a safety-related topic that may apply to multiple nuclear power plants. In that way, it increases the efficiency of the licensing process and reduces the burden on licensees by minimizing the time and resources that both industry and the NRC staff could expend on redundant reviews. For additional information, see the following topics on this page:
Governing Regulations
The NRC's regulations related to topical reports are set forth in Title 10 of the Code of Federal Regulations sections 10 CFR 2.390, 10 CFR 21, 10 CFR 50.5, 10 CFR 50.7, and 10 CFR 170.11.
Requirements
The following requirements apply to topical reports, as discussed on this page:
- Criteria for a Topical Report
- Exceptions to the Criteria
- Topical Reports and Related Plant-Specific Licensing Actions
Criteria for a Topical Report
A report submitted for review as a topical report should meet all four of the following criteria:
- The report deals with a specific safety-related subject regarding a nuclear power plant that requires a safety assessment by the NRC staff; for example, component design, analytical models or techniques, or performance testing of components and/or systems that can be evaluated independently of a specific license application.
(Technical reports submitted for resolution of industry issues or in support of plant-specific license amendment applications are not defined as topical reports under this program). - The report is expected to be referenced by multiple licensees in a number of license amendment requests following staff approval. Generally, a report intended for use by multiple sites of an individual licensee is not considered a topical report.
- The report contains complete and detailed information on the specific subject presented. Conceptual or incomplete preliminary information will not be reviewed.
- NRC approval of the report will increase the efficiency of the review process for applications that reference the report.
Exceptions to the Criteria
Exceptions to these criteria, especially criterion (2), may be allowed on a case-by-case basis if the NRC staff determines that an exception is in the public interest. The applicant must provide such written justification to the staff prior to submitting the topical report for review, preferably at the pre-submittal meeting stage. Justification for an exception could be based on contribution to resolving a safety-related issue, an advancement in technology that would benefit safety or reduce an operational burden, or result in significant cost savings to the industry. Any staff decision to accept for review a topical report that does not meet the four criteria above must also find that the projected staff resources for review of the report are justified.
Before accepting such a report for review, NRC also determines whether the resources expended in the review are worth reducing resources committed to other regulatory activities, such as licensing actions.
The NRC notifies the submitting organization whether each report submitted has been accepted for review as part of the topical report program.
Topical Reports and Related Plant-Specific Licensing Actions
If plant-specific information is needed in support of a topical report, it should generally be submitted as part of the topical report, either in the body of the topical report or as appendices to the topical report, as opposed to a separate concurrent "pilot plant" application. In general, reviews of plant-specific licensing actions, that reference a topical report under review, are not accepted for review in parallel with the referenced topical report review until the staff publishes the draft safety evaluation for the topical report following resolution of technical issues and identification of any limitations/conditions to use of the topical report. If the Vendor/Owners Group has prior knowledge that a licensee plans to submit a license amendment application referencing a topical report, which is either proposed or currently under staff review, the Vendor/ Owners Group should contact the cognizant Vendor/ Owners Group Project Manager to discuss the merits and potential problems with such a submittal.
The need for a separate concurrent demonstration or pilot license amendment request will be discussed and agreed upon at the pre-submittal meeting. If the staff agrees that such a pilot amendment will facilitate the topical report review, it will normally be submitted as a supplement to the topical report and will be reviewed, and either approved or denied, as part of the topical report review. Upon staff issuance of the topical report draft safety evaluation, the pilot application licensee must then submit a license amendment request referencing the approved topical report. If the amendment request complies fully with the topical report, the staff should be able to issue the amendment upon expiration of the Federal Register notice.
