ML18338A252
| ML18338A252 | |
| Person / Time | |
|---|---|
| Issue date: | 10/31/2018 |
| From: | Edward Helvenston Research and Test Reactors Licensing Projects Branch |
| To: | |
| Helvenston E | |
| Shared Package | |
| ML18333A271 | List: |
| References | |
| Download: ML18338A252 (19) | |
Text
License Amendment Requests and 10 CFR 2.390 Withholding TRTR Annual Meeting October 31, 2018 Ed Helvenston, Project Manager RTR Licensing Branch, U.S. NRC
License Amendments - Regulations
- 10 CFR 50.59(c)(1): a license amendment is required if:
- 1) TS changes are required; and/or
- 2) any of the eight criteria in 10 CFR 50.59(c)(2) are met
- 50.90: license amendment requires application to NRC, fully describing the changes desired, and following, as far as applicable, the form prescribed for original applications (50.36, NUREG-1537)
- 50.92(a): in determining whether to issue an amendment, NRC is guided by the considerations which govern issuance of initial licenses to the extent applicable and appropriate 2
License Amendment Requests (LARs) - Pre-Submission
- Early communication with NRC Project Manager
- Public meetings (e.g., phase zero meetings) or may confer informally with NRC staff 3
LARs - Submission
- Send to NRC Document Control Desk, or use NRC Electronic Information Exchange system (10 CFR 50.4(a))
- Must submit under oath or affirmation (10 CFR 50.30(b))
- Cover letter may include requested priority/timeframe/schedule (with basis), if appropriate 4
- Is there is sufficient technical information in scope and depth to allow NRC to begin detailed technical review?
- Does the LAR have any readily apparent information insufficiencies with respect to regulatory requirements or characterization of licensing basis?
- Acceptance review information requests are separate from request for additional information (RAI) process, and are intended to address completeness for docketing (and reduce RAIs) 5
- Does application describe:
- What is being changed?
- What is the relation to safety?
- How is the licensing basis affected?
- What makes the change acceptable?
- Are significant calculations or analyses missing?
- Does application include:
- Oath or affirmation?
- Marked-up TS change pages and description/justification for ALL TS/license changes?
- Physical security, emergency planning, environmental, etc.
information, if applicable?
6
- If LAR is not acceptable for review, NRC may discuss with licensee and send letter providing opportunity to supplement
- If LAR is acceptable for review, NRC will begin detailed technical review and send acceptance letter with estimated review schedule 7
- NRC staff may request additional information (10 CFR 2.102)
- RAIs used when information needed to make a regulatory finding is:
- Not included in initial submission;
- Not contained in other docketed correspondence; and
- Cannot be reasonably inferred from docketed or other public information.
- NRC staff may provide draft RAIs to ensure understanding
- RAI response deadline extensions require a letter to NRC 8
LARs - Issuance of Amendment NRC staff must find that:
- There is reasonable assurance that the health and safety of the public will not be endangered by operation in the proposed manner;
- There is reasonable assurance that such activities will be conducted in compliance with NRC regulations; and
- The issuance of the amendment will not be inimical to the common defense and security or to the health and safety of the public.
9
LARs - Issuance of Amendment
- Do the licensees bases for TS/license changes make sense?
- Has the licensee adequately considered implications for normal operation, as well as potential failure scenarios?
- Has the licensee provided enough detail that the NRC staff can independently reach safety conclusions (e.g., by using its own engineering judgement and/or confirmatory calculations)?
10
10 CFR 2.390, Public inspections, exemptions, requests for withholding 11
10 CFR 2.390 - Overview
- Licensees submitting a document to NRC may request that the document, or a portion of it, be withheld from public disclosure because it contains certain information (10 CFR 2.390(b))
- For example: Trade secrets and commercial or financial information obtained from a person and privileged or confidential (i.e., proprietary information) (2.390(a)(4)) can be withheld from disclosure 12
10 CFR 2.390 - Requirements for Withholding Requests Requirements for withholding requests are in 2.390(b):
- Make request at the time document is submitted (2.390(b)(1))
- Mark documents (2.390(b)(1)(i)(A-B))
Language such as proprietary information withheld from public disclosure under 10 CFR 2.390 at top of each page Should generally also provide redacted version (without marking)
No requirement to mark transmittal documents if no sensitive information 13
10 CFR 2.390 - Requirements for Withholding Requests Requirements for withholding requests (continued):
- Provide affidavit (2.390)(b)(1)(ii-iii))
Identifies document to be withheld, and the locations of sensitive information in the document Identifies official position of person making affidavit Includes harm statement Declares basis for withholding (i.e., which part of 2.390(a))
For proprietary information to be withheld under 2.390(a)(4),
executed by owner of information, and addresses with specificity each of the considerations listed in 2.390(b)(4)(i-v) 14
10 CFR 2.390 - Criteria for NRC Determination In accordance with 10 CFR 2.390(b)(4)(i-v), when determining whether information is proprietary information that should be withheld from disclosure, the NRC will consider:
- Whether information has been held in confidence by owner
- Whether information is of a type customarily held in confidence by owner
- Whether information is transmitted to and received by NRC in confidence
- Whether information is available in public sources
- Whether disclosure of information is likely to cause substantial harm to owners competitive position 15
10 CFR 2.390 - Process
- Withholding request review is separate from a LAR acceptance review
- NRC will generally respond with letter accepting request, or explaining deficiencies
- Generally, licensee may request withdrawal of information if a withholding request is not granted 16
10 CFR 2.390 - A Few Other Points
- Security-related information: 10 CFR 2.390(d)
- Personal privacy information: 10 CFR 2.390(a)(6)
- Public meetings 17
Summary
- When in doubt ask your PM 18
Thank you for your attention, any questions?
Contact information:
Ed Helvenston, U.S. NRC 301-415-4067 Edward.Helvenston@nrc.gov 19