ML25108A142
| ML25108A142 | |
| Person / Time | |
|---|---|
| Site: | Triso-X |
| Issue date: | 05/05/2025 |
| From: | Matt Bartlett NRC/NMSS/DFM/FFLB |
| To: | TRISO-X |
| Shared Package | |
| ML25108A140 | List: |
| References | |
| EPID L-2022-NEW-0005 | |
| Download: ML25108A142 (1) | |
Text
MBartlett - Set 13 for Chapters 1 and 2 (Project Manager Review) - RAIs and Observations Enclosure Chapter 1 and 2 (Project Manager Review) Round 2 - Request for Additional Information and Observations Chapter 1 RAI 1 Process
Description:
Regulatory Basis:
This information is necessary to demonstrate compliance with the regulations in the following sections:
10 CFR 70.22(a)(2), The activity for which the special nuclear material is requested, or in which special nuclear material will be produced, the place at which the activity is to be performed and the general plan for carrying out the activity; 10 CFR 70.22(a)(4) The name, amount, and specifications (including the chemical and physical form and, where applicable, isotopic content) of the SNM the applicant proposes to use or produce; and 10 CFR 70.65, Additional content of applications, subsection (b)(2-4), which also requires a description of the process with sufficient detail to understand the overall function.
Guidance on demonstrating compliance with this regulation is provided in NUREG-1520, Revision 2, Section 1.1.4.3.2 which states, The process overview is acceptable if it summarizes the major chemical or mechanical processes involving licensable quantities of radioactive material based, in part, on information presented in the ISA summary. This description should include the building locations of major process components and brief accounts of the process steps.
Describe Issue:
The process description in the license application LA Section 1.1.3, General Process Description mentions the DUNE process, but does not provide information on what it includes.
The DUNE process is described in the ISA Summary Figure 3.1, TRISOX FFF Process Flow Diagram, and section 3.1, Incoming Feed Shipping and Transportation, in more detail. Its also described in the Emergency Plan Section 1.1.1.1, ADUN SNM Receipt, as part of ADUN process. In addition, the text description in the Receipt of Uranium Feedstock on LA Chapter 1 page 1-13 says the material arrives on site as uranium oxide (U3O8) but does not mention receipt of uranyl nitrate for TX-1 or include a description of the DUNE process. The description of receipt of both uranyl nitrate and U3O8 feedstock and the DUNE process needs to be consistent in the LA, ISA Summary, and Emergency plan to provide a clear understanding of how it fits in the overall fuel fabrication process.
Information Needed:
Update the descriptions of the receipt of uranyl nitrate and the DUNE process consistently throughout the license application (LA) documents (e.g., LA Section 1.1.3 and ISA Summary Section 3.1, Emergency Plan Section 1.1.1.1) in addition to the description of the U3O8 feedstock. Ensure the LA, ISA Summary, Emergency Plan, etc. contain a consistent description of both types of feedstocks.
MBartlett - Set 13 for Chapters 1 and 2 (Project Manager Review) - RAIs and Observations 2
Observation:
Observation 1 - Kernel Conversion:
The ISA Section 3.4, Kernel Conversion states, The dried microspheres are converted in a high temperature furnace to fuel kernels of uranium compounds, such as uranium dioxide (UO2) and uranium dicarbide (UCO) Clarify if UCO should be uranium dicarbide or uranium oxycarbide.
Observation 2 - Equivalent Experience:
LA Section 1.2.7, Terminology/Definitions under the term Equivalent Experience the definition states, For the purpose of meeting educational requirements described throughout the license, two (2) years experience is considered to be equivalent to one (1) year of post-secondary education. For example, eight (8) years of applicable experience will satisfy the requirement for a B.S. degree (4 years of post-secondary education). Please add the word applicable in front of the word experience in the first part of the definitions, similar to the language in the example.
Chapter 2 RAI-1 Qualifications:
Regulatory Basis:
The information below is necessary to demonstrate compliance with the regulations in 10 CFR 70.22, Contents of applications, sub-section (a)(6), The technical qualifications, including training and experience of the applicant and members of his staff to engage in the proposed activities in accordance with the regulations in this chapter.
Guidance for demonstrating compliance with these regulations is provided in NUREG-1520, Revision 2, Section 2.3, Areas of Review which states in part, The applicant should also describe its qualification criteria with regard to education (i.e., degree and field), training, and experience for key management positions. Management positions for which such criteria should be described include the facility manager, operations manager, shift supervisor, and managers for various safety and environmental disciplines. Alternative named management positions could be proposed. Qualification criteria should be described generally, in terms of academic credentials, formal continuing education, and work experience. For example, bachelors degree in nuclear engineering or related scientific or engineering field, with 5 years of experience managing the operations of a nuclear fuel manufacturing facility.
In addition, NUREG-1520, Revision 2, Section 2.4.3 Regulatory Acceptance Criterion, A.1, states, The applicant has identified and functionally described the specific organizational groups that are responsible for managing the design, construction, operations, and modifications of the facility or licensed activities. The application also includes organizational charts.
Describe the Issue:
The qualifications discussed in the last paragraph of LA Section 2.3.4 for the regulatory affairs manager states, The minimum qualifications for a Regulatory Affairs discipline manager are a BS/BA or advanced degree (masters or doctorate) in science or engineering and at least five years of management experience in the nuclear industry, a nuclear related field, and/or in assignments involving regulatory activities [emphasis added].
MBartlett - Set 13 for Chapters 1 and 2 (Project Manager Review) - RAIs and Observations 3
The use of the and/or (i.e., or) in the last part of the sentence means that 5 years of experience in the nuclear industry or nuclear-related field can be replaced with any experience in other regulatory activities. In addition, several of the qualifications throughout section 2.3, Organizational Responsibilities, Authority, and Qualifications use the phrase, or other highly regulated field. These statements are not clear because regulatory activities and other highly regulated fields are general terms that could include any local, state, or federal regulated activity that may include a host of activities (e.g., fishing, farming, driving, etc.), which would not be relevant to the corresponding management positions.
Information Needed:
Update the qualification sections throughout the license application documents (e.g., 2.3) to clarify the scope or processes used to ensure that experience in other regulatory activities or other highly regulated fields can be used as an adequate substitute for the required technical experience (e.g., nuclear experience). For example:
describe the process, program, or individuals that will be used to ensure the substituted experience is adequate (e.g., substituted experience is reviewed and approved through XXX [describe the process, program, or individual]);
consider stating the type of regulatory activities or highly regulated industry fields that are considered equivalent for each of the applicable technical areas (e.g., describe what equivalent experience can be used in place of nuclear experience); or replace the phrases regulated activities and other highly regulated fields with language similar to NUREG-1520, Revision 2, Section 2.3, Areas of Review, in the last sentence of the third paragraph which states in part, or related scientific or engineering field; Note:
this type of language is used for some of the existing functions in the LA (e.g.,
manufacturing).
RAI-2 Construction Management Qualifications:
Regulatory Basis:
The regulatory basis for this RAI is the same as for RAI-1.
Describe the Issue:
The qualification and experience requirements identified in LA section 2.6 in the third paragraph states, construction phase oversight of IROFS is provided by TRISO-X personnel within the engineering, regulatory affairs, and quality assurance disciplines that meet the minimum requirements of a BS/BA and/or advanced degree, and at least one year of relevant experience applicable to the technical discipline, scope, and complexity of the construction oversight assignment.
The qualifications in LA section 2.6 for some positions (e.g., discipline and function managers) responsible for overseeing the construction activities appear to be lower than the qualifications requirements described in LA Chapter 2.3. cTRISO-X clarified that the lower qualification requirements represent a minimum baseline that applies for TRISO-X oversight of the construction activities. Because the discipline and function managers qualifications described in LA Chapter 2.3 exceed the minimum qualifications for construction oversight described in LA Section 2.6, the requirements are not intended to be contradictory. The relationship between organizational manager qualifications in LA Section 2.3 and construction qualifications in LA Section 2.6 needs clarification.
MBartlett - Set 13 for Chapters 1 and 2 (Project Manager Review) - RAIs and Observations 4
Information Needed:
Provide additional information in the LA to clarify the relationship between the qualifications for key organizational positions described in LA Section 2.3 and the minimum qualifications for managers overseeing construction described in LA Section 2.6 to verify they are not contradictory.
Clarify in the LA which management positions (e.g., function managers, subordinate managers, any one providing oversight of construction) and under what conditions the qualification requirements in LA Section 2.6 are required (e.g., only during construction oversight).
Describe how different levels of qualifications requirements (e.g., LA 2.3 versus 2.6) for the same management positions are applied so that they do not conflict (e.g., more stringent qualifications take president, the level of qualifications in LA 2.6 are a minimum
- so both can apply, lower qualifications apply to subordinates).
RAI-3 Corrective Actions for Construction:
Regulatory Basis:
This RAI has the same regulatory basis as RAI 1.
Describe the Issue:
The last sentence of the third paragraph in section 2.6 states, Issues or problems identified during construction of IROFS are referred to the incident investigations and corrective action program this statement indicates that only construction problems related to IROFS will be reported to a corrective actions program. Construction problems may also impact other safety, security, and environmental areas (e.g., safety programs, management measures, security programs, protection of the environment, etc.).
Information Needed:
Expand the scope of the commitment to apply to any construction problems that could have an impact on safety, security, and protection of the environment or explain the alternate program that will be used for non-IROFS construction issues that may have a regulatory nexus.
RAI-4 Transition from Construction to Operations:
Regulatory Basis:
The information below is necessary to demonstrate compliance with the regulations in:
10 CFR 70.22(a)(6) The technical qualifications, including training and experience of the applicant and members of his staff to engage in the proposed activities in accordance with the regulations in this chapter; 10 CFR 70.22(a)(7) A description of equipment and facilities which will be used by the applicant to protect health and minimize danger to life or property; 10 CFR 70.22(a)(8) Proposed procedures to protect health and minimize danger to life or property; and Guidance on demonstrating compliance with this regulation is provided in NUREG-1520, Revision 2, Section 2.4.3 (4) which states, The applicant has described specific plans to commission the facilitys startup and operation, including the transition from the startup phase to operations, under the direct supervision of the applicants personnel responsible for safe operations. The application clearly describes the roles and responsibilities of the different functions engaged in these commissioning activities.
MBartlett - Set 13 for Chapters 1 and 2 (Project Manager Review) - RAIs and Observations 5
Describe the Issue:
The last paragraph of LA Section 2.6 states, The turnover will include physical systems and corresponding design information and records. Following turnover, the manufacturing organization will be responsible for system maintenance and configuration control.
This turnover is not well defined and appears inconsistent with earlier statements that the same organizational structure will oversee both construction and operations. Since the existing organizational structural is already responsible for construction and operations, there is a lack of description of what will be turned over and what management structure will receive whatever is being turned over. Based on the discussion in the RAI alignment call held May 1, 2025, TRISO-X explained that the turnover refers to a change in activities from construction to operational readiness and does not represent a change in the management structure.
Information Needed:
Clarify in the RAI response what is meant by the phrase turnover identified in LA Section 2.6 in the last paragraph. Provide sufficient information to understand what is being turned and how it impacts the organizational structure or responsibilities, if at all.
Observations:
Observation 1 - Consistent Description of Functions Functional areas are described inconsistently throughout LA Chapter 2. In LA Figure 2-1, Functional Organization Chart, there are 16 functional areas identified. However, LA Section 2.3 only describes 8 of the functions including:
nuclear criticality safety; radiation protection; environmental protection; industrial, chemical, and fire safety; integrated safety analysis; licensing; material control and accountability; security; and emergency preparedness.
The NRC staff understands that more description is provided for functions that have a nexus to safety, safeguards, and regulatory affairs. However, the absence of a description of the other functions raises questions about consistency. The NRC staff also note there is a general description of the discipline responsibilities in LA Section 2.2, but there is no corresponding general description of the functions. Consider adding a general description of the role of function managers to section 2.2, similar to that provided for discipline managers. This type of general explanation of the purpose of functions would help resolve the absences of the more detailed discussion for those functions not addressed specifically in LA Section 2.3 (i.e., it would get across the idea that there is a general description for all disciplines and functions in 2.2 with some additional detail provided for certain key functions in 2.3).