Enclosure 3 

Talking Points for Financial Assurance Regarding 

Draft Request for Additional Information Responses 

The draft responses, on a high level and for the most part, look OK; but there are two areas we 

may wish to discuss with International Isotopes, Inc., (INIS): 

(1) For question FA-1-A, INIS was essentially asked to justify/revise their costs, so that they 

are based off costs of a third party. Third-party labor generally includes the labor rate + 

overhead + profit. In their responses, INIS added contractor profit but left overhead 

unchanged. Overhead, in their estimate, is presently 25 percent; which appears low. 

From the response, it cannot be determined if this is reasonable. INIS may wish to 

justify their reliance on an overhead rate of 25 percent, or appropriately increase it. 

(2) For FA-2, INIS should clarify the costs of disposal and shipping for DUF6, DUF4, DUO2 

and UO2. 

(3) For questions FA-4 and 5, INIS should provide more information regarding their previous 

experience with similar clean-up operations. NUREG-1757, Volume 3, Appendix A.3.1.3 

states that such “Justifications” based on “past experience” are likely to be adequate 

only if the past experience is relevant; therefore, the cost estimate should reference 

decommissioning projects with comparable facilities, materials, processes, 

management, regulatory requirements, and price levels.” 

(4) For FA-5, INIS should support their response by providing a source of the quoted rates 

(e.g., copy of a contract). 

(5) For FA-7, regarding proforma (forward looking) financial statements, can INIS suggest 

additional information (e.g., whether INIS has any outstanding contracts from fuel 

enrichment facilities for depleted uranium deconversion or contracts for the purchase of 

fluorine from the extraction process, etc.). 

[Note: The NRC is considering if a license condition should be implemented for financial 

assurance. The condition would require the decommissioning cost estimates and 

associated funding levels to be updated by IIFP and approved by the NRC on a yearly 

basis (rather than the minimum 3-year basis required by the regulations).] 

RAI-HF-1(A). 

The request for additional information (RAI) requests that the applicant identify the Human 

System Interfaces (HSI) involved in the items relied on for safety (IROFs). The staff found the 

intent to meet the guidance provided in NUREG-0700, NUREG-0711, and NUREG-1520, 

Rev. 1, Appendix E, acceptable. However, further information is required to satisfy the 

guidance provided by these NUREGs. The staff’s assessment of the responses to the RAIs 

contained in this letter identify many, but not all, of the areas for which further information should 

be addressed in the implementation plan (later referred to as the Human Factors Design Review 

Plan by the applicant). 
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Talking Points for Human Factors Regarding 

Draft Request for Additional Information Responses 

Follow-on RAI 1: The commitment to guidance in NUREG-0711 and NUREG-1520, Rev. 1, 

Appendix E implies the human factors implementation plan/human factors engineering (HFE) 

Design Review Plan will be incorporated in the license application. Discuss the need to 

incorporate the HFE Design Review Plan into the license application. 

The staff assumes that guidance in NUREG-0700, 0711, and 1520 will be supplemented by an 

HSI design or HSI style guide developed from industry practices by the applicant, which is more 

focused toward a fuel processing facility. Discuss whether the style guide will be available for 

staff’s review. 

Follow-on RAI 2: The HSIs associated with the IROFS are not identified. Identify the HSIs used 

in the IROFS including actions, HSIs involved, and the consequences: such that the reviewer 

can understand the actions, HSIs involved, and the consequences (NUREG 1520 Rev. 1, 

Appendix A, Criteria A). 

Follow on RAI 3: The staff requests that the response be amended to indicate that further 

information, in the form of the implementation plans, be included in the license documentation. 

RAI HF-1(b). 

Provide the process to develop the items that will be included in the HFE Design Review Plan 

(Implementation Plan) (e.g., process for performing an Operational Experience review, a 

process for performing functional allocation analysis). 

HF-2. 

The RAI HF-2 requests a better description of the HFE experience/expectations of the 

integrated safety analysis team. This should include responsibilities and authority which are 

needed to ensure compliance with the guidance in NUREG-0700 and NUREG-0711. The 

description should demonstrate that the HFE will have sufficient weight to require changes to 

the design necessary to ensure safety, and sufficient experience and knowledge to capture and 

apply human factors guidance to the design. Filling of this role as soon as possible is 

necessary to provide reasonable assurance that human factors are being considered in the 

design. 

HF-3(a).

The terms “applicable” and “appropriate” are unclear. Discuss the need to identify the control 

rooms, controls, and processes that are subject to the HFE Design Review Plan. Discuss how 

the appropriate monitoring, recording, alarm notification and control instrumentation will be 

determined to provide the latest, relevant information to the operators that allow for control of 

the processes. 
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HF-3(b).

The minimum inventory list described should be broken down in terms of each control process. 

Describe the process for ensuring that the draft minimum inventory list will be kept up to date 

and will be included in the HFE Design Review Plan. The process for defining this list and 

updating this inventory should be included in the HFE Design Review Plan. 

HF-3(c). 

Include the stated information in the HFE Design Review Plan. Discuss the level of information 

that will be included in the HFE Design Review Plan; including how similar process plants will be 

identified, how many will be reviewed, the process for identifying how new technologies will be 

identified, and the process to determine how information will be presented. Discuss how task 

analysis will be used. 

The response states that “MIL-STD 1472, etc.,” will be used to inform the design. The term 

“etc.” is not specific. The HFE Design Review Plan should specify which established HFE 

principles and guidelines, besides MIL-STD 1472, will be used to drive the layout. 

HF-3(d).

Describe the process used to ensure that extraneous controls and displays will be identified and 

removed, as indicated by NUREG-0711 and NUREG-1520, Rev. 1, Appendix E, in the HFE 

Design Review Plan. Indicate how the task verification process will identify unnecessary 

controls and displays. 

The intent and purpose of the statement, “Appropriate HSI components may not appear to be 

associated with personnel tasks,” is not clear. 

HF-4(b).

The staff found the intent acceptable and will review the Plan when it is submitted. Further 

development of the Safety Evaluation Report depends on the quality of this implementation 

plan. 

HF-5(a).

A formal process for review of operational experience should be included in the HFE Design 

Review Plan. The HFE Design Review Plan should include description of the extent to which 

operator interviews/surveys on existing HSI technology will be conducted and incorporated into 

the facility design and IROFS. As indicated in the RAI, identify the types of facilities that were 

evaluated, and define how the information derived from operational experience reviews will be 

used to inform other aspects of the design. 

HF-5(b).

As indicated in HF-5(a), a formal process for review of operational experience is needed and 

should be included in the HFE Design Review Plan. Further development of the Safety 

Evaluation Report depends on the quality of this Plan. 

The staff will review the Plan when it is submitted to determine if the process proposed is 

satisfactory with respect to the guidance. 

 
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HF-6. 

As indicated in NUREG-0711 and NUREG-1520 Rev. 1, Appendix E, the Design Review Plan 

should indicate how the staffing requirements are based on the functional allocation and task 

analysis results. 

HF-7(a).

The applicant’s commitment that the Verification and Validation (V&V) Plan will be subject to the 

same requirements of the QAP should be included in the HFE Design Review Plan. The staff 

will review the HFE Design Review Plan to determine whether it meets the intent of the 

guidance. 

HF-7(b).

The RAI response to HFE-7(b) should be incorporated into the license application and the HFE 

Design Review Plan. Additional detail on the process to be used in the V&V process should be 

incorporated into the Human Factors Design Review Plan. 

HF-7(c). 

The goals identified by the applicant should be included in the HFE Design Review Plan. 

Consider rephrasing, “Human ergonomic function” for clarity (e.g., ergonomics of the human 

system interface or ergonomics of the facility). The staff request clarification of whether 

“ergonomic” concerns will also include environmental concerns such as lighting, noise, and 

personal protective equipment use. The staff requests clarification of whether the validation of 

staffing assignments will include assessment of personnel or workload demands. The staff also 

request clarification of whether the controls, displays and alarms will be assessed to assure 

appropriate situational awareness of the operator. Discuss whether other techniques besides 

walkthroughs will be used to validate the system, and identify those techniques. 

HF-7(d).

Incorporate this information into the Human factors Design Review Plan. 

HF-7(f).

The staff requests that a human factors review be included for any section of the facility that 

involves humans—not just the HSI.