Guidance on the Implementation of 

Integrated Safety Analysis 

Requirements for 10 CFR Part 40 

Facilities Authorized to Possess 

2,000 Kilograms or More of Uranium 

Hexafluoride

Draft Report for Comment 

Office of Nuclear Material Safety and Safeguards 

NUREG-1962
Guidance on the Implementation of

Integrated Safety Analysis 

Requirements for 10 CFR Part 40 

Facilities Authorized to Possess 

2,000 Kilograms or More of Uranium 

Hexafluoride

Draft Report for Comment 

Manuscript Completed: March 2011 

Date Published: April 2011 

Office of Nuclear Material Safety and Safeguards 

NUREG-1962
COMMENTS ON DRAFT REPORT 

Any interested party may submit comments on this report for consideration by the NRC staff. 

Comments may be accompanied by additional relevant information or supporting data. Please 

specify the report number NUREG-1962, draft, in your comments, and send them within 75 days 

of the date that the proposed Part 40 rule is published in the Federal Register (scheduled for mid-May, 

2011) to the following address: 

Chief, Rules, Announcements, and Directives Branch 

U.S. Nuclear Regulatory Commission 

Mail Stop TWB5-BOIM 

Washington, DC 20555-0001 

Electronic comments may be submitted to the NRC via the website http://www.regulations.gov 

under Docket ill NRC-2011-0080. 

For any questions about the material in this report, please contact: 

M. Bartlett 

EBB02 B-15 

U.S. Nuclear Regulatory Commission 

Washington, DC 20555-0001 

Phone: 301-492-3119 

E-mail: matthew. bartlett@nrc.gov 
iii 

ABSTRACT 

This NUREG is written to provide guidance on the implementation of additional regulatory 

requirements for licensees authorized under Title 10 of the Code of Federal Regulations

(10 CFR), Part 40 (Part 40), “Domestic Licensing of Source Material,” to possess threshold 

quantities of uranium hexafluoride (UF6). The document primarily provides guidance on the 

implementation of integrated safety analysis (ISA) requirements and also addresses updates to 

the emergency plan criteria, and reporting requirements among others. These requirements 

were implemented in the Part 40 rulemaking, dated [ENTER FEDERAL REGISTER DATE FOR 

PUBLICATION OF FINAL RULE FOR PART 40]. The guidance consists of references to the 

applicable portions of existing ISA guidance in NUREG-1513, “Integrated Safety Analysis 

Guidance Document,” issued May 2001 and NUREG-1520, Revision 1, “Standard Review Plan 

for the Review of a License Application for a Fuel Cycle Facility,” issued May 2010, which were 

written to support the implementation of ISA requirements in 10 CFR Part 70 (Part 70), 

“Domestic Licensing of Special Nuclear Material.” 

The Commission directed the staff to implement the Part 40 ISA requirements in the Staff 

Requirements Memorandum to SECY-07-0146, “Regulatory Options for Licensing New Uranium 

Conversion and Depleted Uranium Deconversion Facilities,” dated October 10, 2007. The 

requirements are designed to better address the potential radiological and chemical hazards 

resulting from UF6 and hydrogen fluoride at certain source material facilities. 

The ISA requirements are incorporated into Part 40, Subpart H, “Additional Requirements for 

Certain Licensees Authorized to Possess 2000 Kilograms (4400 lbs) or More of Uranium 

Hexafluoride,” and parallel the majority of ISA requirements in the existing Part 70, Subpart H, 

“Additional Requirements for Certain Licensees Authorized To Possess a Critical Mass of 

Special Nuclear Material.” The chief difference between the Part 40 and Part 70 ISA regulations 

is the absence of criticality requirements in the Part 40 ISA provisions. Due to the similarities in 

the ISA requirements between Part 40 and Part 70, portions of NUREG-1513 and NUREG-1520 

apply to the Part 40 ISA. The guidance which is not applicable to Part 40, e.g., criticality, are 

noted and explained. 
 

This page is intentionally left blank.
 

v 

CONTENTS 

ABSTRACT ................................................................................................................................ iii

CONTENTS ................................................................................................................................ v

LIST OF TABLES ....................................................................................................................... v

1. Purpose ................................................................................................................................ 1

2. Overview............................................................................................................................... 1

3. Description of Rule Changes to 10 CFR Part 40 ................................................................... 2

4. Completing an ISA Consistent with the 1988 NRC/OSHA MOU ........................................... 2

5. Applicability of NUREG-1513 TO 10 CFR Part 40 ISA .......................................................... 4

6. Applicability of NUREG-1520, Revision 1 to 10 CFR Part 40 ISA ......................................... 5

7. Sections in NUREG-1520 that Involve ISA ............................................................................ 6

8. Information Requirements for the ISA Summary ................................................................... 6

LIST OF TABLES 

Table 1 Requirements Added to 10 CFR Part 40 in the ISA Rulemaking ................................... 7

Table 2 Crosswalk between Requirements in 10 CFR Part 40, 10 CFR Part 70, and 

NUREG-1520 ............................................................................................................... 9

Table 3 Location of ISA Terms and Requirements in NUREG-1520, Revision 1 ...................... 12

Table 4 Expanded Information Requirements for the ISA Summary ........................................ 15
This page is intentionally left blank.
 

1 

GUIDANCE ON THE IMPLEMENTATION OF INTEGRATED SAFETY 

ANALYSIS REQUIREMENTS FOR 10 CFR PART 40 FACILITIES 

1. Purpose

This document provides information on implementing the requirements of Title 10 of the Code of 

Federal Regulations (CFR) Part 40, Subpart H requirements (e.g., Integrated Safety Analysis, 

emergency plan criteria, and reporting requirements) for source material licensees who are 

authorized to possess 2,000 kilograms or more of uranium hexafluoride (UF6). 

2. Overview

The Commission’s staff requirements memoranda (SRM) M070308B, “Briefing on NMSS 

Programs, Performance, and Plans,” dated March 22, 2007, and SRM to SECY-07-0146, 

“Regulatory Options for Licensing New Uranium Conversion and Depleted Uranium 

Deconversion Facilities,” dated October 10, 2007, directed the U.S. Nuclear Regulatory 

Commission’s (NRC) staff to proceed with rulemaking to ensure that chemical hazards at 

certain source material facilities have a more risk-informed regulatory structure. The threshold 

for triggering the Part 40 Integrated Safety Analysis (ISA) requirements was established at 

2,000 kilograms (kg) of uranium hexafluoride, an amount which has the potential to produce 

hydrogen fluoride (HF)—a hazardous chemical—in significant quantities (450 kg). Both the 

Occupational Safety and Health Administration (OSHA) and the U.S. Environmental Protection 

Agency (EPA) have established 450 kg of HF as the threshold for requiring additional safety 

analyses.1

 

This NUREG begins with Table 1, “Requirements Added to 10 CFR Part 40 in the ISA 

Rulemaking,” which provides a description of the major changes to Part 40 which were 

implemented in the rulemaking, dated [ENTER DATE OF FEDERAL REGISTER FOR FINAL 

RULE]. As part of the rulemaking, the Commission directed the NRC staff in SRM to 

SECY-10-0128, “Proposed Rule: Domestic Licensing of Source Material - 

Amendments/Integrated Safety Analysis,” to provide a clear explanation as to how to evaluate 

the NRC/OSHA Memorandum of Understanding (MOU) criterion 3 when completing the ISA. 

Guidance on implementing the MOU in the ISA is provided along with multiple examples. 

The NUREG provides guidance for the ISA primarily through references to existing guidance 

developed for Part 70. One section focuses on NUREG-1513, “Integrated Safety Analysis 

Guidance Document,” which illustrates how to develop an ISA. The bulk of NUREG-1513 can 

be applied directly to Part 40, excluding some topics unique to Part 70 (e.g., criticality). The ISA 

guidance NUREG-1520, ”Standard Review Plan for the Review of a License Application for a 

Fuel Cycle Facility,” is also applicable to Part 40, Subpart H. NUREG-1520 provides the NRC’s 

acceptance review criteria for the ISA Summary. 

To facilitate the comparison between Part 40 and Part 70, Table 2, “Crosswalk between 

Requirements in 10 CFR Part 40, 10 CFR Part 70, and NUREG 1520,” provides a crosswalk 

between the Part 40 ISA requirements and the existing ISA requirements in Part 70. The 

 

1

See 29 CFR 1910.119, “Regulatory Options for Licensing New Uranium Conversion and Depleted 

Uranium Deconversion Facilities,” (the OSHA Process Safety Management 

regulation); 40 CFR Part 68, “Chemical Accident Prevention Provisions” (EPA’s Risk Management 

Program requirements); and 40 CFR Part 355, “Emergency Planning and Notification. 
2 

NUREG also describes the differences between the existing guidance, written for Part 70, and 

the Part 40 ISA requirements. The two remaining tables (Tables 3 and 4) provide additional 

cross references between the ISA requirements in Part 40, Part 70, and the guidance in 

NUREG-1520. Table 3, “Location of ISA Terms and Requirements Referenced in 

NUREG-1520, Revision 1,” contains a list of the major ISA terms and requirements used in the 

proposed Part 40, Subpart H. Table 4, “Expanded Information Requirements for the Integrated 

Safety Analysis Summary,” lists the regulatory criteria and expectations for each type of 

information to be required in the ISA Summary. Table 4 also includes the Part 40 criteria and 

their matching counterparts in the existing Part 70 requirements. 

3. Description of Rule Changes to 10 CFR Part 40

Table 1 describes the requirements in 10 CFR Part 40 for licensees who are authorized to 

possess 2,000 kilograms or more of uranium hexafluoride, briefly describes the background for 

the regulatory change, and indicates the available guidance for each requirement. 

4. Completing an ISA Consistent with the 1988 NRC/OSHA MOU 

To achieve greater worker protection, in 1988 the U.S. Nuclear Regulatory Commission (NRC) 

and the Occupational Safety and Health Administration (OSHA) entered into a Memorandum of 

Understanding (MOU) (53 FR 43950-43952; 1988). As stated there, the NRC regulates nuclear 

and radiological safety at NRC-licensed facilities, including plant conditions which “present an 

increased radiation risk to workers.” The NRC and OSHA have jurisdiction over the safety and 

health of workers at NRC-licensed facilities. OSHA regulates industrial safety in general. 

The Commission directed the staff in the SRM-SECY-10-0128 to evaluate whether there was 

need to update the 1988 MOU or provide additional guidance on its implementation. The 

evaluation determined that the MOU adequately defines the dividing line between NRC and 

OSHA regulated activities for Part 40 facilities authorized to possess 2,000 kg or more of UF6. 

This section provides the additional guidance on completing the ISA consistent with the MOU. 

The 1988 MOU defined the agencies’ general areas of responsibilities for the regulation of 

industrial hazards at nuclear facilities. The MOU identified the following four areas of 

responsibility. The NRC has regulatory oversight for the first three areas, whereas OSHA has 

authority for the fourth area: 

1. Radiation risk produced by radioactive materials; 

2. Chemical risk produced by radioactive materials; 

3. Plant conditions that affect the safety of radioactive materials and thus present an 

increased radiation risk to workers; and 

4. Plant conditions that result in an occupational risk, but do not affect the safety of 

licensed radioactive materials. 

The NRC’s area of responsibility covered by the first criterion is easily identified, but the second 

and third criteria often require some evaluation. In SRM-SECY-10-0128, the Commission 

directed the staff to provide a clear explanation as to how a licensee should evaluate the MOU’s 

third criterion when completing its ISA. 
3 

Conducting an ISA requires evaluating all the accident sequences which meet the criteria in 

§ 40.82. Some of these criteria are drawn from the NRC–OSHA MOU and include § 40.82(c)(i) 

(radiological hazards); § 40.82(c)(ii) (chemicals produced from radioactive materials); and 

§ 40.82(c)(iii) (plant conditions which could impact the safety of radioactive material). Once the 

accident sequences are identified, the applicant must meet the performance requirements in 

§ 40.81. 

Accident sequences which involve radioactive materials directly are easily identified to be under 

NRC’s jurisdiction and must be considered in the ISA. In addition, accidents which do not result 

directly from the hazards of radioactive materials may still be under NRC’s jurisdiction and 

considered in the ISA, if they fall within the scope of the MOU criteria 2 (chemicals produced 

from radioactive material) and 3 (impact the safety of radioactive materials). 

This guidance provides a number of examples to illustrate the types of events which fall within 

the MOU criteria 2 and 3, and are subject to the ISA § 40.82 requirements. Some of the 

examples have previously been published following the establishment of the ISA requirements 

for Part 70 in September 2000. These examples are included below. 

1. Statements of Consideration (SOC) for Part 70.61 (64 FR 41341-41342; July 30, 1999). 

 “As an example of the third MOU area, if the failure of a chemical system adjacent to a 

nuclear system could affect the safety of the nuclear system such that the radiation dose 

(and associated likelihood of that accident) exceeded a performance requirement, the 

chemical system failure would be within the scope of the ISA and the means to prevent 

the chemical system failure from impacting the nuclear system would be within NRC’s 

regulatory purview.” 

2. March 10, 2003, NRC Memorandum entitled, “Regulatory Authority Over Chemical 

Hazards at Fuel Cycle Facilities,” (Accession Number ML030700317). 

• “An example corresponding to Item (2) [MOU criterion 2] above would be uranium 

hexafluoride which reacts with moisture in the air to produce uranyl fluoride and 

hydrofluoric acid.” 

• “Another example of Item (2) [MOU criterion 2] would be the release of nitric acid that 

would result during a dissolution operation where an excess amount of nitric acid is 

added to uranium oxide.” 

• “An example of Item (3) [MOU criterion 3] above would be a spill of aqueous 

ammonia due to overfilling of a mixing vessel containing both liquid ammonia and 

uranyl fluoride which would increase radiological risk.” 

In addition to these previously published examples, the following examples are provided. 

3. A chlorine tank located onsite but at a distance from radioactive material ruptures. The 

resulting cloud of chlorine vapor prevents an NRC-licensed operator from taking actions 

needed to ensure radiological safety (such as the shutting down or isolation of 

radiological processes) prior to evacuating a process control area. 

4. A fire in an electrical box results in loss of power to a radiological safety system such as 

ventilation or radiation monitoring devises. 

5. A crane lift accident which results in the rupture of a radioactive material container due 

to a drop, puncture, or a fire involving a forklift. 

The scenarios in these examples have the potential to impact the safety of radioactive material. 

Therefore, consistent with MOU criterion 3, these types of accident sequences involve hazards 
4 

that are within NRC’s jurisdiction and must be evaluated in the ISA. The accident sequences 

would be analyzed in the ISA as required by § 40.82(c); and if they challenge the performance 

requirements in § 40.81, they would require implementation of additional items relied on for 

safety to mitigate the risk. 

The example below illustrates a hazard which would not impact radioactive material and, 

consistent with MOU criterion 4, would be under OSHA jurisdiction and would not need to be 

evaluated in the ISA. 

6. An event results in a chemical spill, chemical plume, smoke plume, fire, etc., in a 

warehouse building located onsite but isolated from radioactive material, such that the 

hazard could not impact NRC-licensed material or licensed activities. 

Since the event would have no impact on the safety of radioactive material, the event would not 

challenge the performance requirements in § 40.81. In addition, this type of event would not 

need to be evaluated in the ISA because it is outside the scope of § 40.82. 

The examples provided above illustrate the types of events which must be evaluated in the ISA 

to ensure that the accident sequences meet the performance requirements in § 40.81. 

Comprehensive implementation of the ISA requirements addresses the areas specified in the 

MOU and provides reasonable assurance of safety. 

5. Applicability of NUREG-1513 TO 10 CFR Part 40 ISA

After publication of the final rule for ISA in 10 CFR Part 70 on September 18, 2000, the U.S. 

Nuclear Regulatory Commission (NRC) developed NUREG-1513 entitled, “Integrated Safety 

Analysis Guidance Document.” As indicated in the document’s abstract, the purpose was to 

provide general guidance to NRC’s fuel cycle licensee/applicants on how to perform an ISA and 

document the results. In particular, the document defines an ISA, identifies its role in a facility's 

safety program, identifies and describes several generally accepted ISA methods, and provides 

guidance in choosing a method. 

Although NUREG-1513 was written to apply to the ISA requirements in Part 70, the document 

also applies to the ISA requirements in Part 40, with minor modifications. The following 

modification should be taken into consideration when applying NUREG-1513 for guidance on 

Part 40 ISA. 

1. The NUREG-1513 only references sections in Part 70. The guidance also applies to the 

corresponding sections in Part 40, which can be identified using the crosswalk provided 

in Table 2 of this guidance document. 

2. The NUREG-1513 was written to apply to facilities that process special nuclear material. 

As a result, there are a number of references to criticality, double contingency, and fuel 

fabrication. Such hazards are outside the scope of the Part 40 facilities and should be 

disregarded. However, the guidance for developing an ISA still applies to Part 40 

because it also addresses radiological and chemical hazards, which are present at 

Part 40 facilities. The references to criticality, double contingency, and fuel fabrication 

are generally illustrative and accompanied by additional examples of radiological and 

chemical hazards, e.g., vaporization of uranium hexafluoride. 
5 

3. The Appendix B provides several useful examples for Part 40 and Part 70. 

• Appendix B.1 entitled, “What-If Analysis of the Pelletizing, Rod-loading, and Fuel 

Bundle Assembly Steps,” provides an example of a what-if analysis as applied to 

a fuel fabrication system involving criticality. The details of the analysis do not 

apply to Part 40, but the procedure for conducting the analysis is illustrative of 

the what-if process that may be used for Part 40. 

• Appendix B.2 and B.3 provide examples which are more likely applicable to a 

Part 40 facility. 

Aside from these items, the guidance in NUREG-1513 should be used by Part 40 applicants 

and licensees as guidance for developing an ISA. 

6. Applicability of NUREG-1520, Revision 1 to 10 CFR Part 40 ISA

The majority of information for ISA regulations is contained in NUREG-1520 and also applies to 

Part 40, Subpart H, via reference, with only minor modifications. These changes are described 

in the crosswalk in Table 2. This guidance includes: 

• NUREG-1520, Chapter 3, “Integrated Safety Analysis (ISA) and ISA Summary;” 

• Appendix A to Chapter 3, “Example Procedure for Accident Sequence Evaluation;” 

• Chapter 11, “Management Measures,” apply to the Part 40 requirements; and 

• Specific ISA references spread throughout each chapter of NUREG-1520. 

A few considerations must be kept in mind when applying NUREG-1520 to Part 40. References 

to criticality are not applicable to Part 40 licensees, since such licensees are not authorized to 

possess special nuclear material. A criticality event involving source material is not credible at 

facilities that are licensed under 10 CFR Part 40. NUREG-1520 references to subsections in 

Part 70 must be substituted with references to Part 40. (Note: Table 2 provides the crosswalk 

for these substitutions.) In addition, the following sections in NUREG-1520 require minor 

modification to be applied to Part 40 ISA. 

• NUREG-1520, Section 3.1, “Purpose of Review” 

This section describes the Part 70 facilities that are required to implement an ISA. The 

Part 40 facilities subject to Subpart H are major facilities that are authorized to possess 

2000 kg or more of UF6 source material. 

• NUREG-1520, Section 3.3.2, “ISA Summary and ISA Documentation” 

The Part 70 acceptance criteria require demonstration of the ISA methodology on three 

or four nuclear criticality events. The operations of Part 40 licensees do not generate 

criticality hazards, so the ISA methodology should be demonstrated on three or four 

hazardous chemical events. Table 2 provides the crosswalk between Part 40, Part 70 

and NUREG-1520. A discussion of the differences between the Parts is also provided. 
6 

7. Sections in NUREG-1520 that Involve ISA

Although Chapters 3, “ISA and ISA Summary,” and Chapter 11, “Management Measures” of 

NUREG-1520 address the implementation of ISA, additional information on ISA is spread 

throughout the NUREG. This is because the ISA impacts the safety basis for each of the major 

review areas (e.g., chemical, fire, radiation safety, etc.). Table 3 lists the sections in NUREG1520, outside of Chapters 3 and 11, which contain additional information about implementing 

the ISA. 

8. Information Requirements for the ISA Summary

Table 4 is an amended version of Table 3.1, “Information Requirements for the ISA Summary,” 

in NUREG-1520, Revision 1, Section 3.4. The table lists the regulatory citations and 

expectations for each type of information required in the ISA Summary, e.g., (1) site and facility 

characteristics, (2) ISA methods, (3) hazards and accident analysis, and (4) items relied on for 

safety. Table 4 augments Table 3.1 from NUREG-1520 with the 10 CFR Part 40 citations that 

correspond to the 10 CFR Part 70 requirements given in the original table.
7 

Table 1 Requirements Added to 10 CFR Part 40 in the ISA Rulemaking 

Requirement Discussion 

40.3(a) 

Requirement 

“After [Effective date of final rule], Agreement States may not issue new 

licenses covering the [authorization for] possession of 2000 kilograms 

(4400 lbs) or more of uranium hexafluoride.” 

Background 

2,000 kg of UF6 have the potential to release hazardous quantities of HF if 

released during an event. Consistent with the direction in the SRM to 

SECY-07-0146, the Commission determined that facilities with this quantity of 

material should be regulated by the NRC and not by Agreement States. 

Guidance This section does not affect the technical review. No additional guidance is 

provided. 

 New 

Subpart H in 

Par 40 

“The regulations in §§ 40.81 through 40.89 apply, in addition to other 

applicable Commission regulations, to each applicant or licensee that is or 

plans to be authorized to possess 2000 kilograms (4400 lbs) or more of 

uranium hexafluoride.” 

Background 

Subpart H has been added to 10 CFR Part 40 to implement ISA 

requirements. This subpart is structured parallel to 10 CFR Part 70, 

Subpart H, “Additional Requirements for Certain Licensees Authorized To 

Possess a Critical Mass of Special Nuclear Material.” However, references to 

criticality have been removed because Part 40 regulates source and 

byproduct material, which does not include special nuclear material. 

Guidance 

Table 2 of this guidance document provides a section-by-section crosswalk 

between the regulations in 10 CFR Part 40 and the existing regulations in 

10 CFR Part 70. A description of any differences between the two parts is 

provided after each comparison. 

40.84(b) 

Requirement 

“In any evaluation submitted under § 40.31(j)(1)(i), licensees and applicants 

must also show that, in the event of a release, an acute chemical exposure 

from licensed material or hazardous chemicals produced from licensed 

materials would result in neither irreversible nor mild transient health effects to 

a member of the public offsite. If such an evaluation is not submitted, 

licensees and applicants must submit an emergency plan pursuant to 

§ 40.31(j)(3).” 

Background 

Under 10 CFR 40.31(j)(1), applicants have one of two options: they must 

either submit an evaluation that complies with 10 CFR 40.31(j)(1)(i) or submit 

an emergency plan in accordance with 10 CFR 40.31(j)(1)(ii). The 

10 CFR 40.31(j)(1)(i) criterion is based on uranium exposure. The regulation 

in 10 CFR 40.84(b) adds an additional emergency evaluation criterion. This 

criterion requires licensees authorized to posses 2,000 kg or more of UF6 to 

demonstrate that hazardous chemicals involved in the processing of licensed 

material cannot cause mild transient health effects offsite. If a credible 
Table 1 Requirements Added to 10 CFR Part 40 in the ISA Rulemaking 

(Continued) 

8 

Requirement Discussion 

potential exists to exceed this threshold, the licensee is required to implement 

an emergency plan in accordance with 10 CFR 40.31(j). 

Guidance 

The guidance in NUREG-1520, Sections 8.3.2 and 8.4.3.2, applies to the new 

emergency evaluation criterion. References in the guidance to 

10 CFR 70.22(i)(1)(i) apply to 10 CFR 40.31(j)(1)(i), and references to 

10 CFR 70.22(i)(1)(ii) apply to 10 CFR 40.31(j)(1)(ii). 

40.88(a) and 

(b) 

Requirement 

“(a) [...] the following events must be reported to the NRC Operations Center 

within 1 hour of discovery, supplemented with the information described in 

paragraph (d)(1) of this section as it becomes available, followed by a written 

report within 60 days: [...] 

(b) [...] the following events must also be reported to the NRC Operations 

Center within 24 hours of discovery, supplemented with the information 

described in Paragraph (d)(1) of this section as it becomes available, followed 

by a written report within 60 days: [...]” 

Background 

The agency is considering a rule change to the reporting requirements in 

10 CFR Part 70 similar to those implemented here (i.e., change 30 to 

60 days). The change allows licensees to submit the supplemental reports 

required by 10 CFR 40.88(a) and (b) within 60 days. 

Guidance This section does not affect the technical review. No additional guidance is 

provided. 

40.89(a)(1) 

Requirement 

The Commission shall require a systematic and documented analysis 

pursuant to paragraph (b) of this section for backfits that it seeks to impose. 

Background 

The regulations in 10 CFR 40.89 govern the backfitting of new or modified 

requirements for 10 CFR Part 40 licensees authorized to possess 2,000 kg or 

more of UF6. The regulation requires that the NRC justify each backfit with a 

backfit analysis (10 CFR 40.89(a)(2)) or a documented evaluation 

(10 CFR 40.89(a)(4)) and specify its use and contents. 

Guidance 

The backfit analysis is conducted by the NRC, so no external guidance is 

provided for its implementation. However, several internal guidance 

documents are publically available and provide additional information. These 

include (1) NRC Management Directive 8.4, “Management of Facility-Specific 

Backfitting and Information Collection,” issued June 2001; and (2) NMSS 

P&P 1-82, Revision 1, “10 CFR Part 70 Backfit Guidance,” issued 

October 2005. 
9 

Table 2 Crosswalk between Requirements in 10 CFR Part 40, 10 CFR Part 70, an

10 CFR PART 40 10 CFR PART 70 NUREG-1520 Discussion 

40.3a 

Denial of Licensing 

by Agreement 

States 

70.3 License 

Requirements NA 

10 CFR Part 40.3a requires licensees that apossess 2,000 kg or more of UF6 to be licenCFR Part 70 does not contain a parallel req

40.4 

Definitions 

70.4 

Definitions Glossary 

The NRC has added definitions for the followto 10 CFR 40.4: 

• acute • available and reliable to perform the

needed 

• configuration management • defense-in-depth • hazardous chemicals produced from • integrated safety analysis • integrated safety analysis summary • items relied on for safety • management measures • unacceptable performance deficienc• worker 

These definitions are identical to the definitiwith two exceptions. First, the defense-in-din a footnote to 10 CFR 70.64 has been plasection of 10 CFR 40.4. Second, the referebeen removed from the ISA definition. 

40.80 

Applicability 

70.60 

Applicability Section 9.4.3.3 

10 CFR Part 40 facilities are subject to ISA the quantity of UF6 they possess, rather tha

special nuclear material as for 10 CFR Part 
Table 2 Crosswalk between Requirements in 10 CFR Part 40, 10 CFR Part 70, an

(continued) 

10 

10 CFR PART 40 10 CFR PART 70 NUREG-1520 Discussion 

40.81 

Performance 

Requirements 

70.61 

Performance 

Requirements 

Throughout, but 

especially in 

Chapter 3 (on ISAs) 

Both 10 CFR Part 40 and 10 CFR Part 70 hperformance requirements except for the crwhich do not apply to 10 CFR Part 40 licensreferences to criticality have been removed 

40.82 

Safety Program and 

Integrated Safety 

Analysis 

70.62 

Safety Program and 

Integrated Safety 

Analysis 

Introduction 

Chapters 2–3, 5–7, 

11 

The times specified for existing 10 CFR Parcomplete an ISA, ISA plan, and ISA summaperformance deficiencies have been modifieimpact the ISA development schedule ratheISA documents. 

40.83 

Requirements for 

New Facilities or 

New Processes at 

Existing Facilities 

70.64

 Requirements for 

New Facilities or 

New Processes at 

Existing Facilities 

Introduction 

Chapters 3, 5–8, 11 

The reference to criticality design has been 10 CFR 70.64 contained a footnote that defThis definition has been moved to 10 CFR 4

40.84 

Additional Content 

of Applications 

70.65 

Additional Content 

of Applications 

Introduction 

Chapters 1, 3, 5–7, 

11 

10 CFR 40.84(b) adds a new emergency evaddition to the existing criterion in 10 CFR 410 CFR 40.31(j), facilities must either submprovide an evaluation that demonstrates limuranium. In 10 CFR 40.84(b), the NRC addevaluation criterion that requires facilities to limited public exposure to hazardous chemipublic offsite. This additional criterion does 10 CFR Part 70. 

40.85 

Additional 

Requirements for 

Approval of License 

Application 

70.66 

Additional 

Requirements for 

Approval of License 

Application 

Introduction 

Chapter 3 No substantive differences 
Table 2 Crosswalk between Requirements in 10 CFR Part 40, 10 CFR Part 70, an

(continued) 

11 

10 CFR PART 40 10 CFR PART 70 NUREG-1520 Discussion 

40.86 

Facility Changes 

and Change 

Process 

70.72 

Facility Changes 

and Change 

Process 

Introduction 

Chapters 3, 5–8, 11 No substantive differences 

40.87 

Renewal of 

Licenses 

70.73 

Renewal of 

Licenses 

NA No substantive differences 

40.88 

Additional Reporting 

Requirements 

70.74 

Additional Reporting 

Requirements 

Chapters 4, 5, 11 

10 CFR 40.88 contains the combined ISA redrawn from 10 CFR 70.50, 10 CFR 70.74, a10 CFR Part 70. The ISA 10 CFR Part 70 rspread throughout each of these three sectiassembled in one place in 10 CFR 40.88. Rhave been removed. In addition, the 10 CFfor a 30-day follow-up report for events notif1 hour and 24 hours has been changed to 610 CFR Part 40. 

40.89 

Backfitting 

70.76 

Backfitting NA 

The wording of 10 CFR 40.89(a) differs from 10 CFR 70.76(a) in that the new backfit reqlimited subset of part 40 licensees (i.e. thospossess 2,000 kg or more of UF6). In additi

40.89 do not apply to a licensee until their ISapproved by the NRC. 
12 

Table 3 Location of ISA Terms and Requirements in NUREG-1520, Revi

Each term or ISA requirement is referenced in the list of chapters and subsections located in NUREG-

ISA SUMMARY 

Chapter 1 General Information 1.1.3 Areas of Review 1.1.5 Review Procedures 1.3.1 Purpose of Review 1.3.3 Areas of Review 1.3.5 Review Procedures 1.3.6 Evaluation Findings Chapter 4 Radiation Protection 4.1 Purpose of Review 4.3 Areas of Review 4.4.7 Radiation Surveys and Monitoring Programs 4.4.8 Control of Radiological Risk Resulting from Accidents 4.6 Evaluation Findings Chapter 6 Chemical Process Safety 6.1 Purpose of the Review 6.3 Areas of Review 6.4.3 Regulatory Acceptance Criteria 6.5.2 Safety Evaluation Chapter 7 Fire Safety 7.1 Purpose of Review 7.3 Areas of Review 7.4.3 Regulatory Acceptance Criteria 7.5.1 Acceptance Review Chapter 8 Emergency Management 8.3 Areas of Review 8.3.2 Evaluation That No Emergency Plan is Required 8.4.3 Regulatory Acceptance Criteria 8.6.2 Safety Evaluation Chapter 9 Environmental Protection 9.3 Areas of Review 9.4.3 Regulatory Acceptance Criteria 9.5 Review Procedures 9.5.2 Integrated Safety Analysis Summary

ISA AND SUBPART 

Introduction Pages 1–4 Chapter 1 General Information 1.3.2 Responsibility for Review Chapter 2 Organization and Administ2.3 Areas of Review Chapter 4 Radiation Protection 4.4.4 Commitment to Written Procedures 4.4.5 Radiation Safety Training 4.4.8 Control of Radiological Risk ResultinChapter 6 Chemical Process Safety 6.3 Areas of Review Chapter 7 Fire Safety 7.3 Areas of Review 

IROFS 

Chapter 2 Organization and Administ2.3 Areas of Review 2.4.3 Regulatory Acceptance Criteria Chapter 4 Radiation Protection 4.3 Areas of Review 4.4.5 Radiation Safety Training Chapter 6 Chemical Process Safety 6.1 Purpose of the Review 6.4.3 Regulatory Acceptance Criteria 6.5.2 Safety Evaluation Chapter 7 Fire Safety 7.1 Purpose of Review 7.4.3 Regulatory Acceptance Criteria 7.5.1 Acceptance Review Chapter 9 Environmental Protection 9.5.2 Integrated Safety Analysis Summary 9.5.3 Management Measures 
Table 3 Location of ISA Terms and Requirements in NUREG-1520, Revision 1 

13 

Each term or ISA requirement is referenced in the list of chapters and subsections located in NUREG-

MANAGEMENT MEASURES 

Chapter 2 Organization and Administration 2.3 Areas of Review 2.4.3 Regulatory Acceptance Criteria Chapter 4 Radiation Protection 4.3 Areas of Review 4.4.5 Radiation Safety Training Chapter 6 Chemical Process Safety 6.5.2 Safety Evaluation Chapter 7 Fire Safety 7.1 Purpose of Review Chapter 9 Environmental Protection 9.5 Review Procedures Chapter 11 Management Measures

10 CFR 40.82 (10 CFR 7

Introduction Pages 1–4 Chapter 2 Organization and Administ2.4.1 Regulatory Requirements Chapter 4 Radiation Protection 4.4.8 Control of Radiological Risk ResultinChapter 6 Chemical Process Safety 6.3 Areas of Review 6.4.1 Regulatory Requirements 6.4.3 Regulatory Acceptance Criteria Chapter 7 Fire Safety 7.3 Areas of Review 7.4.1 Regulatory Requirements 7.4.3 Regulatory Acceptance Criteria 7.5.1 Acceptance Review 10 CFR 40.80 (10 CFR 70.60) 

Chapter 9 Environmental Protection 9.4.3 Regulatory Acceptance Criteria

10 CFR 40.81 (10 CFR 70.61) 

Introduction Pages 1–4 Chapter 4 Radiation Protection 4.1 Purpose of Review 4.4.7 Radiation Surveys and Monitoring Programs 4.4.8 Control of Radiological Risk Resulting from Accidents 4.6 Evaluation Findings Chapter 6 Chemical Process Safety 6.3 Areas of Review 6.4.1 Regulatory Requirements 6.4.3 Regulatory Acceptance Criteria Chapter 7 Fire Safety 7.4.1 Regulatory Requirements 7.4.3 Regulatory Acceptance Criteria 7.5.1 Acceptance Review 7.6 Evaluation Findings Chapter 9 Environmental Protection9.5.3 Management Measures

10 CFR 40.83 (10 CFR 7

Introduction Pages 1–4 Chapter 6 Chemical Process Safety 6.4.1 Regulatory Requirements 6.4.3 Regulatory Acceptance Criteria 6.5.2 Safety Evaluation Chapter 7 Fire Safety 7.4.1 Regulatory Requirements 7.4.3 Regulatory Acceptance Criteria 7.5.1 Acceptance Review 7.6 Evaluation Findings Chapter 8 Emergency Management 8.4.1 Regulatory Requirements
Table 3 Location of ISA Terms and Requirements in NUREG-1520, Revision 1 

14 

Each term or ISA requirement is referenced in the list of chapters and subsections located in NUREG-

10 CFR 40.84 (10 CFR 70.65) 

Introduction Pages 1–4 Chapter 1 General Information 1.1.4 Acceptance Requirement 1.1.6 Evaluation of Findings 1.2.6 Evaluation of Findings 1.3.4 Acceptance Criteria Chapter 6 Chemical Process Safety6.1 Purpose of the Review 6.3 Areas of Review 6.4.1 Regulatory Requirements 6.4.3 Regulatory Acceptance Criteria Chapter 7 Fire Safety 7.4.1 Regulatory Requirements 7.4.3 Regulatory Acceptance Criteria 7.5.1 Acceptance Review 7.6 Evaluation Findings

10 CFR 40.86 (10 CFR 4

Introduction Pages 1–4 Chapter 6 Chemical Process Safety 6.4.3 Regulatory Acceptance Criteria 6.5.2 Safety Evaluation Chapter 7 Fire Safety 7.4.3 Regulatory Acceptance Criteria 7.5.1 Acceptance Review

10 CFR 40.88 (10 CFR 4

Chapter 4 Radiation Protection 4.4.9 Additional Program Commitments Chapter 6 Chemical Process Safety 6.4.1 Regulatory Requirements
15 

Table 4 Expanded Information Requirements for the ISA Summary 

INFORMATION CATEGORY AND 

REQUIREMENT 

10 CFR PART 70 

REGULATORY 

CITATION 

10 CFR PART 40 

REGULATORY 

CITATION 

NUREG-1520, 

CHAPTER 3 

SECTION 

REFERENCE 

Site and Facility Characteristics: 

Site description 70.65(b)(1) 40.84(c)(1) 3.4.3.2(1) 

Facility description 70.65(b)(2) 40.84(c)(2) 3.4.3.2(2) 

Compliance with baseline design 

criteria 

70.64 

(if applicable) 

40.83 

(if applicable) 3.4.3.2(4)(d) 

ISA Method(s): 

ISA method(s) description 70.65(b)(5) 40.84(c)(5) 3.4.3.2(5) 

ISA team description 70.65(b)(5) 40.84(c)(5) 3.4.3.2(5) 

Quantitative standards for acute 

chemical exposures 70.65(b)(7) 40.84(c)(7) 3.4.3.2(7) 

Definition of “unlikely,” “highly 

unlikely,” and “credible” 70.65(b)(9) 40.84(c)(9) 3.4.3.2(9) 

Hazards and Accident Analysis: 

Description of processes analyzed 70.65(b)(3) 40.84(c)(3) 3.4.3.2(3) 

Identification of hazards 70.65(b)(3) 40.84(c)(3) 3.4.3.2(3) 

Description of accident sequences 70.65(b)(3) 40.84(c)(3) 3.4.3.2(3) 

Characterization of high- and 

intermediate-consequence accident 

sequences 

70.65(b)(3) 40.84(c)(3) 3.4.3.2(3) 

Items Relied on for Safety: 

List and description of IROFS 70.65(b)(6) 40.84(c)(6) 3.4.3.2(6) 

Description of IROFS’s link to 

accident sequences to show 

compliance with 10 CFR 70.61 

70.65(b)(6) 40.84(c)(6) 3.4.3.2(4) and (6)

IROFS management measures 70.65(b)(4) 40.84(c)(4) 3.4.3.2(4)(b) and 

(6) 

List of sole IROFS 70.65(b)(8) 40.84(c)(8) 3.4.3.2(8) 
This page is intentionally left blank.
NRC FORM 335 

(12.2010) 

NRCMD3.7 

u.s. NUCLEAR REGULATORY COMMISSION 1. REPORT NUMBER 

BIBLIOGRAPHIC DATA SHEET 

(See instructions on /he reverse) 

2. TITLE AND SUBTITLE 

Guidance on the Implementation of Integrated Safety Analysis Requirements for 1 0 CFR Part 

40 Facilities Authorized to Possess 2,000 Kilograms or More of Uranium Hexafluo ride 

5. AUTHOR(S) 

Division of Fuel Cycle Safety and Safeguards 

(Assigned by NRC. Add Vol~ Supp.. Rev •• 

and Addendum Numbers, if any.) 

NUREG-1962 

3. DATE REPORT PUBLISHED 

I 

MONTH YEAR 

April 2011 

4. FIN OR GRANT NUMBER 

6. TYPE OF REPORT 

Draft 

7. PERIOD COVERED (Inclusive Dales) 

2011 fOlWard 

8. PERFORMI NG ORGANIZATION - NAME AND ADDRESS (If NRC, provide Division, Office or Region, U.S. Nuclear Regula/olY Commission, and mailing address; if contractor, 

ptovide name and maifjng address.) 

Division of Fuel Cycle Safety and Safeguards 

Office of Nuclear Material Safety and Safeguards 

U.S Nuclear Rgulatory Commission 

Washington DC 20555-0001 

9. SPONSORING ORGANIZATION - NAME AND ADDRESS (If NRC, type "Same as above"; if con/Jactor, provide NRC Division, OffIce or Region, U.S. Nuclear Regulatory Commission, and maiNng address.) 

Same as above 

10. SUPPLEMENTARY NOTES 

Developed to support the rulemakina to incorporate Intearated Safety Analvsis into 10 CFR Part 40 

11. ABSTRACT (200 WOlds or less) 

This NUREG provides guidance on the implementation of additional regulatory req uirements for licensees authorized under 

Title 10 of the Code of Federal Regulations (CFR), Part 40 (Part 40), "Domestic Licensing of Source Material," to possess 

threshold quantities of uranium hexafluoride. Guidance is provided on the impl ementation of integrated safety analysis (ISA) 

requirements and also addresses updates to the emergency plan criteria, and rep orting requirements. The guidance consists 

of references to the applicable portions of existing ISA guidance in NURE 1513, "Integrated Safety Analysis Guidance 

Document" issued May 2001 and NUREG 1520 Revision 1, ·Standard Review Plan for the Review of a License Application for 

a Fuel Cycle Facility," issued May 2010, which were written to support the impl ementation of ISA requirements in 10 CFR Part 

70 (Part 70), "Domestic Licensing of Special Nuclear Material." The ISA requir ements are incorporated into Part 40, Subpart H 

,and parallel the majority of ISA requirements in the existing Part 70, Subpart H. The chief difference between the Part 40 and 

Part 70 ISA regulations is the absence of criticality requirements in the Part 40 ISA provisions. 

12. KEY WORDS/DESCRIPTORS (Ust words or phrases that will assist researchers in /ocaUng the reporl.) 

Integrated Safety Analysis 

Subpart H 

Uranium Hexifluoride 

Backflt 

Item Relied on for Safety 

Management Measures 

Performance Requirements 

2000 killograms 

UF6 

NRC FORM 335 (12·2010) 

13. AVAIlABILITY STATEMENT 

Unlimited 

14. SECURITY ClASSIFICA110N 

(This Page} 

Unclassified 

(This RepOl/) 

Unclassified 

15. NUMBER OF PAGES 

16. PRICE