ML24352A093
| ML24352A093 | |
| Person / Time | |
|---|---|
| Site: | Triso-X |
| Issue date: | 11/15/2024 |
| From: | NRC/NMSS/DFM/FFLB |
| To: | |
| Shared Package | |
| ML24352A091 | List: |
| References | |
| Download: ML24352A093 (1) | |
Text
Chapter 2 Supplemental Information Discussion for the TRISO-X Responses to the Requests for Additional Information (RAI) items 1, 3, 5, 7 and 8.
November 15, 2024, 9:00am-11:00am 1
NRC Opening Remarks This is an Observation Meeting in which attendees will have an opportunity to observe the NRC performing its regulatory function or discussing regulatory issues. Attendees will have an opportunity to ask questions of the NRC staff or make comments about the issues discussed following the business portion of the meeting; however, the NRC is not actively soliciting comments toward regulatory decisions at this meeting.
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Supporting Documentation for Chapter 2 Requests for Additional Information (RAI)
- Triso-X, LLC, License Application Chapter 2, Revision 1 dated November 4, 2022 (ML22101A202)
- U.S. Nuclear Regulatory Commission (NRC) Set 2, issued 15 RAIs on July 27, 2023, (ML23198A257)
- TRISO-X responses received August 25, 2023, (ML23237B484).
- Observations on status of the RAIs (ML24115A245, ML24089A202 - Non-Public)
RAIs Resolved: RAI-2, 4, and 6 RAIs Open: RAI-1, 3, 5, 7, and 8
- NRC Issued - ENCLOSURE 1 - RAI Status Update for the Safety and Safeguards Requests for Additional Information for the TRISO-X License Application - ML24115A245 3
RAI Regulatory Basis Summary The complete set of RAIs and the TRISO-X, LLC. (TRISO-X) responses are available on the Nuclear Regulatory Commission (NRC) Agencywide Documents Access and Management System (ADAMS) in the response letter dated July 27, 2023, (ML23198A257).
The following slides support additional discussion of the TRISO-X License Application Chapter 2 RAIs 1, 3, 5, 7, and 8. The RAIs 2, 4, and 6 were resolved by the TRISO-X RAI response. In the following slides, only the Information Needed section of the RAIs is repeated. A summary list of the Regulatory Basis for the RAIs is provided below. Please see the link above for the full RAI description and response.
Regulatory Basis:
RAI 1 - Title 10 to the Code of Federal Regulations (10 CFR) 70.22, Contents of applications, RAI 3, 5, 7 - 10 CFR 70.22(a)(6), and RAI 8 - 10 CFR 70.22(a)(2),
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Chapter 2 RAI-1 Management Hierarchy Information Needed:
Clarify the different levels of managers utilized by TRISO-X (e.g., plant manager, discipline, function, analyst, individual(s) responsible) and their hierarchy relative to each other within the TRISO-X management structure.
Clarify how the different types of managers identified in the LA are represented in LA figure 2-1.
Remaining Open Items:
The description of the management organization in Chapter 2 should be updated to clearly define the management structure, definition of terms for management positions, scope of responsibility, and qualification requirements. The current application uses a ranges of terms for positions in the management structure which makes it difficult to understand the scope of the managers responsibility, the scope of responsibility, and the qualification/training requirements.
Additional Clarification in the License Application:
Consider adding a section (text or table) to the license application that identifies the organizational structure for the TRISO-X management. For example, if this were done for the NRC, it would be a chart that shows the following positions (Commission, Executive Director of Operations, Office Director, Division Director, Branch Chief, Staff). Something like this for TRISO-X would help clarify the roles of the different positions identified in the TRISO-X management structure.
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Chapter 2 RAI-1 Management Hierarchy - continued Additional information needed to provide clarification in the submittal:
Consider simplifying the list of terms utilized for the organizational structure throughout or define how they are related. For each of the management positions identified in Chapter 2, please provide the scope of the responsibility of the position, the relationship to other positions (e.g., how each position fits in the management chain), and the qualification/training requirements.
Note: There are multiple unique terms for managers that appear to have a lot of overlap. The NRC staff review identified 20 terms for manager positions including: supervisor, functional discipline, functional organization, management positions, management team, key personnel, plant manager, discipline manager, senior managers, management personnel, functional areas, individual(s) responsible, functions(s), line management, engineering discipline, analyst, safety function, safety specialist, and ISA function responsible for managing.
The term discipline manager and discipline appear to be used interchangeably in section 2.3.1 and 2.3.2, etc.
Please clarify if the discipline refers to an individual or a group. If the term discipline applies to a group in sections 2.3.2 - 2.3.4, clarify how the experience and training requirements apply to individuals in the group or to just the managers of the group. In addition, the term discipline and function appear to have some overlap.
Also, the training requirements for the functional disciplines needs clarified on which positions are subject to the requirements (e.g., the lead of the function or all individuals in the function).
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Chapter 2 - RAI-3/5 Role of Regulatory Affairs on the Screening Committee Information Needed:
RAI 3 - Provide additional information on the problem identification system, including what it consists of and how it works. Clarify the role of the Regulatory Affairs staff in the screening committee. Clarify the roll of the screening committee in the corrective action program, who serves on it, and how it differs from the safety committee. Please update the application, as appropriate.
RAI 5 - Clarify the role of the Regulatory Affairs Manager in the safety committee (e.g., see LA section 2.3.4, second sentence of the third paragraph, and LA section 2.4, second paragraph, and the relationship to the chairman of the safety committee. Define the term council as used in LA section 2.3.4, third paragraph, and throughout the LA.
Clarify the purpose and role of the council and clarify how it fits into the overall discussion on Regulatory Affairs.
Revise the LA, as needed, to reflect these clarifications.
Remaining Open Items:
The LA Chapter 2 section 2.4 states, safety review committee membership includes discipline managers, or individuals responsible for regulatory affairs functions that meet the qualifications of a discipline manager. This statement seems to indicate multiple levels of managers are involved in the safety review committee.
In the second paragraph of LA Chapter 2 section 2.4, the second sentence states, and the other committee members are required to have the qualifications specified for a discipline manager. Since the first paragraph indicates that positions other than discipline managers are members of the TRISO-X safety review committee, the requirement that all members of the committee be qualified as discipline managers seems to indicate a separate qualification requirement exists for members of the safety review committee.
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Chapter 2 - RAI-3/5 Role of Regulatory Affairs on the Screening Committee Additional Clarification in the License Application:
Please clarify if the safety committee members have different qualification requirements than those specified in the discipline and function sections. As discussed in Chapter 2, RAI-1 follow-up, please also clarify the differences between the discipline and function in the organizational structure.
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Chapter 2 - RAI-7 Experience for the Manufacturing Function Information Needed:
Clarify what is meant in LA section 2.3.2 by the phrase sufficient background in manufacturing-related activities for the manufacturing discipline. Also, clarify the use of and/or in the requirements for manufacturing experience in LA section 2.3.2.
Remaining Open Items:
The proposed RAI update to License Chapter 2, Section 2.3, paragraph 3 adds additional options for substitution of business experience for nuclear experience. The added language provided in the RAI response includes the statement, When substituting type of work experience, two years of non-nuclear experience is equivalent to one year of nuclear experience. This statement appears to not provide an equivalent level of experience for certain positions involving safety or security, (e.g., two years of years business experience would not equate to one year of experience in regulatory affairs, radiation protection, criticality, security, etc.).
Additional information needed to provide clarification in the submittal:
This sentence should be removed or clarified with additional criteria (e.g., substitution of business experience for nuclear experience will be reviewed and approved by the regulatory authority) to provide reasonable assurance in the license application that the proposed substitution of business education for nuclear experience or nuclear education is equivalent so that staff are appropriately qualified for their positions.
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Chapter 2 - RAI-8 Transition to Operations Information Needed:
Clarify how the first, second, and third tests mentioned in LA section 2.6 relate to each other and support the transition plan. Identify a process that goes beyond testing for the transition to include written procedures, corrective actions, management oversight, established goals, etc., as applicable. Identify the management disciplines and functions that will be responsible for implementing the transition plan and clarify the role, if any, of the Regulatory Affairs managers.
Describe how TRISO-X will ensure staff have the appropriate training to transition from construction to operations.
Update the LA as appropriate.
Remaining Open Items:
- 1.
TRISO-X should state how problems will be handled - i.e., reported to a corrective action program and resolved prior to proceeding to operations.
- 2.
In addition, the RAI proposed text revision to Chapter 2 section 2.6 in the middle of the second paragraph states, TRISO-X oversight of the A/E and construction contracts may involve one or more functions as described in Section 2.3, depending on the scope of the design or construction activity. If a construction oversight function is used in addition to oversight provided by the engineering functions, the minimum qualifications required are the same as those for an individual responsible for engineering function(s) as stated in Section 2.3.3.
The statements that oversight may be applied and only if the oversight function is needed call into question the level of TRISO-X oversight of construction to ensure IROFS and management measures are appropriately constructed.
- 3.
The additional qualifications required for the oversight functions in the proposed revision to LA Chapter Section 2.6 (i.e., second sentence in the quotation above) reference the oversight function which needs to be defined.
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Chapter 2 - RAI-8 Transition to Operations Additional information needed to provide clarification in the submittal:
1.
Clarify how issues and problems identified during construction and the transition to operations will be dispositioned and tracked to resolution. Consider providing a pointer to the programs TRISO-X plans to use to track and resolve issues/problems (e.g., corrective action program, safety committee).
2.
(A) Clarify in the text for LA Chapter 2 section 2.6 that the TRISO-X discipline and function managers will provide appropriate oversight of the construction to ensure IROFS and management measures are appropriately implemented.
3.
(B) Clarify the intent of the sentence that states, If a construction oversight function is used in addition to oversight provided by the engineering functions, the minimum qualifications required are the same as those for an individual responsible for engineering function(s) as stated in Section 2.3.3. Note: Please clarify how the Oversight function fits in the overall facility layout.
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