October 11, 2011 

Mr. John J. Miller, CHP 

International Isotopes, Inc. 

4137 Commerce Circle 

Idaho Falls, ID 83401 

SUBJECT: FOLLOW-UP REQUEST FOR ADDITIONAL INFORMATION TO SUPPORT THE 

HUMAN FACTORS, SEISMIC AND STRUCTURAL, INTEGRATED SAFETY 

ANALYSIS AND FINANCIAL ASSURANCE REVIEW FOR THE INTERNATIONAL 

ISOTOPES, INC., APPLICATION (TAC 32739) 

Dear Mr. Miller: 

The U.S. Nuclear Regulatory Commission’s (NRC’s) staff received your responses to our 

Requests for Additional Information (RAI) regarding the Human Factors, Seismic and Structural, 

Integrated Safety Analysis (ISA) and Financial Assurance letters dated May 3, 2011, May 6, 

2011, April 1, 2011, and April 29, 2011, respectively. The NRC staff reviewed your responses 

and requires additional information to complete our review. This additional information is 

needed for the staff to determine regulatory compliance. 

In accordance with Title 10 of the Code of Federal Regulations 2.390 of the NRC’s “Rules of 

Practice,” a copy of this letter and enclosure will be available electronically from the NRC’s 

Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible 

from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic 

Reading Room). 

If you have any questions regarding this letter, please contact Matthew Bartlett at 301-492-

3119, or via E-mail to Matthew.Bartlett@nrc.gov. You may also contact Maria Guardiola at 

301-492-3566, or via E-mail to Maria.Guardiola@nrc.gov. 

 Sincerely, 

/RA/ M. Guardiola for 

 Matthew Bartlett, Project Manager 

 Conversion, Deconversion 

 and Enrichment Branch 

 Division of Fuel Cycle Safety 

 and Safeguards 

 Office of Nuclear Material Safety 

 and Safeguards 

Docket No. 40-9086 

Enclosure: 

Follow-up Request for Additional Information 

 for the Human Factors, Seismic and 

 Structural, ISA and Financial Assurance Review
Mr. John J. Miller, CHP 

International Isotopes, Inc. 

4137 Commerce Circle 

Idaho Falls, ID 83401 

SUBJECT: FOLLOW-UP REQUEST FOR ADDITIONAL INFORMATION TO SUPPORT THE HUMAN 

 FACTORS, SEISMIC AND STRUCTURAL, INTEGRATED SAFETY ANALYSIS AND 

 FINANCIAL ASSURANCE REVIEW FOR THE INTERNATIONAL ISOTOPES, INC., 

 APPLICATION (TAC 32739) 

Dear Mr. Miller: 

The U.S. Nuclear Regulatory Commission’s (NRC’s) staff received your responses to our Requests for 

Additional Information (RAI) regarding the Human Factors, Seismic and Structural, Integrated Safety 

Analysis (ISA) and Financial Assurance letters dated May 3, 2011, May 6, 2011, April 1, 2011, and April 

29, 2011, respectively. The NRC staff reviewed your responses and requires additional information to 

complete our review. This additional information is needed for the staff to determine regulatory 

compliance. 

In accordance with Title 10 of the Code of Federal Regulations 2.390 of the NRC’s “Rules of Practice,” a 

copy of this letter and enclosure will be available electronically from the NRC’s Agencywide Documents 

Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at 

http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room). 

If you have any questions regarding this letter, please contact Matthew Bartlett at 301-492-3119, or via 

E-mail to Matthew.Bartlett@nrc.gov. You may also contact Maria Guardiola at 301-492-3566, or via 

E-mail to Maria.Guardiola@nrc.gov. 

 Sincerely, 

/RA/ M. Guardiola for 

 Matthew Bartlett, Project Manager 

 Conversion, Deconversion 

 and Enrichment Branch 

 Division of Fuel Cycle Safety 

 and Safeguards 

 Office of Nuclear Material Safety 

 and Safeguards 

Docket No. 40-9086 

Enclosure: 

Follow-up Request for Additional Information 

 for the Human Factors, Seismic and 

 Structural, ISA and Financial Assurance Review 

DISTRIBUTION: 

FCSS r/f

ML11273A037 

OFFICE NMSS/CDEB NMSS/CDEB NMSS/CDEB NMSS/CDEB

NAME MGuardidola MBartlett LAllen THiltz 

DATE 10/03/2011 10/03/2011 10/06/2011 10/11/2011 

 OFFICIAL RECORD COPY
 Enclosure 

FINAL REQUESTS FOR ADDITIONAL INFORMATION FOR 

INTERNATIONAL ISOTOPES FLUORINE PRODUCTS 

Human Factors 

In order to demonstrate compliance with the acceptance criteria in NUREG-1520 Revision 1, 

Appendix E to Chapter 3, please provide the following information: 

FRAI-1. The License Application (LA) Sections 3.1.4.4 and 3.1.4.5 of the Human Factors 

Engineering (HFE) Implementation Plan (IP) provide a number of references to 

human factors standards—including NUREG/CR-3331, MIL-STD-1478, MIL-HDBK46855A, and IEEE-1023, which are to be referenced for the Task Analysis, 

Functional Requirements, and Human System Interface Design elements, 

respectively, of the HFE IP. The references to these standards in the application use 

the phrases “similar to” and “or equivalent guidance.” The U.S. Nuclear Regulatory 

Commission (NRC) staff understands that significant portions of the guidance 

documents listed above do not apply to a Part 40 Deconversion facility (e.g., 

International Isotopes Fluorine Products [IIFP]), which is not a nuclear power plant. 

Therefore, a commitment to the entire standard is not appropriate. The NRC staff 

needs adequate assurance that all appropriate portions of the guidance will be 

implemented. Therefore, for each of the three standards listed above, replace the 

phrase “similar to” with a commitment to implement portions of the guidance used to 

meet the acceptance criteria listed in NUREG-1520 Appendix E. Also, remove the 

reference to equivalent guidance. 

Example: HFE IP Section 3.1.4.4 (last paragraph): “IIFP intends to use applicable 

standards as guidance for the functional allocation analysis process. The FAA will 

utilize description analysis methods drawn from NUREG/CR-3331 similar to that 

described in consistent with the sections needed to demonstrate compliance with the

acceptance criteria in NUREG-1520 Appendix E of NUREG/CR-3331 or equivalent 

guidance

FRAI-2. The original HFE RAI-1(a) response (Revision A) contained the following two 

sentences: 

“Human factors and human-system interface were considered as part of the accident analysis 

review and discussion process. However, these considerations of human factor aspects were 

not done at the level and structure of the current NUREG- 1520, Appendix E because the 

accident analysis and PHA information used in developing the IIFP License Application was 

conducted and completed prior to the revisions to NUREG-1520, Revision I Appendix E, 

criterion E.” 

This text was not included in the second HFE RAI response (Revision B). Please 

incorporate a similar statement into LA Section 3.1.4, or other location as 

appropriate. This information is needed to clarify that the HSI was evaluated as part 

of the accident analysis. 

FRAI-3. LA Section 11.1.3, titled “Configuration Management Controls on the Design 

Requirements” contains a commitment to conduct design verification. Provide a 

cross-reference in the HFE IP which refers to LA Section 11.1.3 and states that this 

design verification will also be applied to human factors. This information is needed 

to clarify that the design verification will be applied to human factors.
2 

FRAI-4. RAI HF-F2-1 License Documentation Impact 4 through 8 indicate the HFE Expert will 

be incorporated into the Integrated Safety Analysis Team (ISA). For clarity, add a 

statement or cross-reference in HFE IP Section 3.1.4.2 which indicates the HFE 

Expert will be part of the ISA team. This information is needed to ensure consistency 

between LA Section 3.1.4.2 and the ISA Summary Table 5-2. 

Seismic

FRAI-5. Issue: 

In response to “Follow-Up Clarification to RAI SS-7(5),” the applicant has stated that 

Load Combination 4 for “Severe Environmental Load Combinations” has not been 

used “since the operating basis earthquake load (earthquake load for which plant's 

power production equipment is designed to remain functional without undue risk to 

public health and safety) is not applicable. The emergency generator and UPS 

system are designed to remain functional during any postulated natural phenomena 

hazard event.” 

This combination pertains to continued operation of the items relied on for safety 

(IROFS) structures after earthquakes. 

Request: 

Expand the justification for not using the Severe Environmental Load Combinations 

listed in follow-up RAI response #SS-7-5 Section 3(a) #4, 3(b) #5, and 3(c) #5. To 

include a justification based on compliance with 70.61(e), i.e., IROFS remain 

available and reliable and have management measures [Note: Consider including a 

cross-reference to LA Section 3.1.3 (or other sections) which contain a commitment 

to utilize Management Measures to maintain the IROFS.] 

ISA: 

FRAI-6. LA Section 3.2.4.3, “New Facilities or New Processes at Existing Facilities” contains 

commitments to implement the Baseline Design Criteria (BDC), consistent with 

Title 10 of the Code of Federal Regulations (10 CFR) 70.64. The BDC are intended 

to ensure that a minimum level of good engineering practices, defense-in-depth, and 

safety considerations are incorporated throughout the facility. The BDC must be 

applied to the entire facility, including those safety features which are not designated 

as IROFS. The current commitments in LA Section 3.2.4.3 appear to only apply to 

IROFS. These commitments need to be expanded to also apply to the entire facility, 

including safety features which are not designated as IROFS. Consistent with the 

requirements in 10 CFR Part 70.62(a), expand the Subsections of the LA 3.2.4.3 

including Natural Phenomena Hazards, Fire Protection, Chemical Protection, and 

Emergency Capability to indicate that the BDC addresses the safety systems 

throughout the entire facility. An example of the type of language needed is provided 

below. 

 

Examples: 

 

Section 3.2.4.3 New Facilities.... New text in italics.

 

Natural Phenomena Hazards 

The IIFP Facility design has been developed with natural phenomena in mind such 

that if an external event should occur, the health and safety of the workforce from 
3 

licensed material or chemicals produced from licensed material are maintained. 

“Structures, systems, and components. (SSC)s that are....” 

 

Fire Protection 

The IIFP Facility design provides adequate protection from credible fire and 

explosion accident scenarios by adherence to the requirements of the ISA and 

recognized codes and standards. “SSCs that are IROFS....” 

 

Chemical Protection 

Replace existing wording which is very confusing with the following: The IIFP Facility 

design provides for adequate protection against chemical risks produced from 

licensed material. Chemical protection is addressed in Chapter 6.0 of the LA. 

 

Emergency Capability 

The IIFP Facility design provides for emergency capability to maintain control of 

licensed material and hazardous chemicals produced from licensed material, 

evacuation of onsite personnel, and onsite emergency facilities and services. “SSCs 

that are required....” 

Exemption Request for Financial Assurance: 

FRAI-7. By letter dated August 12, 2011 (Agencywide Documents Access and Management 

System [ADAMS] ML112351140) INIS submitted an exemption request to 

10 CFR 40.36(e) for financial assurance. Specifically the exemption requested a 

modified timeframe for submitting financial assurance for decommissioning which 

states, “provide the financial assurance instruments to the NRC 6 months prior to 

operations and to fund the instruments 21 days prior to operations. 

In a telephone conversation held September 16, 2011, (ADAMS Accession 

No. ML112700375) the NRC expressed concern that INIS may receive contaminated 

equipment during construction as part of their purchase of equipment from the 

Sequoyah Fuels former uranium deconversion facility. The exemption mentions that 

decommission costs may be required for this contamination, but does not include the 

decommissioning cost analysis or funding mechanism required by 40.36. In 

subsequent phone conversions, the NRC staff has come to understand that the 

contamination consists of source material (UF4) and would not exceed 15 lbs. This 

information has not been provided formally to the NRC. 

Consistent with the regulatory requirements in 40.14 and 40.36, provide additional 

information in the exemption request on the type, quantity, and chemical form of 

“contamination” which may be received onsite during construction. Specify how the 

material will be licensed and whether or not it needs to be addressed as part of the 

financial assurance exemption request. If the material is part of the exemption 

request (e.g., not licensed under a general license), address the decommissioning 

costs associated with this “contamination.” If the intent is to limit the “contamination” 

below a regulatory threshold during construction (e.g., a general license, 40.22 or 

40.36(b)), provide a commitment in the LA which specifies the material will not 

exceed the threshold; and summarize the basis for not providing financial assurance 

during construction. 
4 

FRAI-8. The current language in the exemption request contains a number of phrases which 

do not provide an adequate scope to define the extent of the exemption. The 

original exemption request contains several different phrases including, “prior to 

operations,” “prior to start-up,” “prior to licensed operations,” “provide reasonable 

financial assurance,” etc. These phrases are not well defined. 

Consistent with the requirements in 40.36(d), clarify the meaning of the phrases 

“operations” and “start-up” to be the receipt on site of radioactive material under the 

proposed license. Replace the phrase “reasonable financial assurance” with 

“financial assurance in the amount of the cost estimate.”