1

October 13, 2015 

MEMORANDUM TO: Marissa G. Bailey, Director 

 Division of Fuel Cycle Safety, Safeguards, 

 and Environmental Review 

 Office of Nuclear Material Safety 

 and Safeguards 

FROM: Soly I. Soto-Lugo, Project Manager /RA/ 

 Fuel Manufacturing Branch 

 Division of Fuel Cycle Safety, Safeguards, 

 and Environmental Review 

 Office of Nuclear Material Safety 

 and Safeguards 

SUBJECT: SUMMARY OF SEPTEMBER 23, 2015, MEETING WITH THE 

INDUSTRY AND STAKEHOLDERS TO DISCUSS FUEL CYCLE 

REGULATORY ACTIVITIES AND CUMULATIVE EFFECTS OF 

REGULATION 

The staff of the U.S. Nuclear Regulatory Commission (NRC) met with representatives of the 

Nuclear Energy Institute (NEI), fuel cycle industry, and members of the public on September 23, 

2015, in Rockville, Maryland. The purpose of the Category 2 public meeting was to discuss 

several topics of mutual interest, including updates to the Cumulative Effects of Regulation 

Integrated Schedule, Revised Fuel Cycle Oversight Process (RFCOP), and Cyber Security. 

The meeting announcement is available in the Agencywide Documents Access and 

Management System under the accession number ML15244A707. 

Cumulative Effects of Regulation 

The NRC provided updates to the various rulemaking and regulatory activities involving the fuel 

cycle industry listed in the Integrated Schedule of Regulatory Activities for Fuel Cycle. The NRC 

staff communicated that completed activities such as the Generic Letter (GL) and Interim Staff 

Guidance (ISG) on Natural Phenomena Hazards will be removed from the integrated schedule 

in the next revision. 

CONTACT: Soly Soto-Lugo, NMSS/FCSE 

 (301) 415-7528 
M. Bailey 2 

 

The NRC staff and industry discussed certain aspects of the proposed Title 10 of the Code of 

Federal Regulations (10 CFR) Part 73 rulemaking. Based on the regulatory basis, industry 

expressed concern that the proposed rulemaking, as it relates to transportation of special 

nuclear material, could be challenging for fuel cycle facilities. The NRC staff noted industry’s 

concern and indicated that there will be future public interactions through the rulemaking 

process where the industry will have the opportunity to further discuss these concerns. 

Additionally, the industry communicated that the time between releasing the preliminary 

language for information and the public comment period on the preliminary language was too 

long. The NRC staff explained that the staff expects to release the preliminary draft rule text 

and guidance language as the rule is developed and that seven months was the planned 

development time. 

 

The NRC staff and industry discussed certain aspects of the Part 21 rulemaking. The NRC staff 

indicated that the final Regulatory Basis was issued in August 2015. Additionally, the staff 

indicated that Draft Regulatory Guide (DG)-1292, “Dedication of Commercial Grade Items,” will 

be issued prior to preparation of the proposed rule to endorse the Electric Power Research 

Institute Guidance for reactors. The NRC staff provided status of the DG, which has been 

prepared and is entering concurrence. The NRC staff also mentioned that they will be engaging 

industry on the path forward for non-reactor guidance, specifically, to determine the role industry 

would prefer in the preparation of evaluating and reporting guidance (DG-1291). Public 

meetings will be held in October and November on this topic. 

For 10 CFR Part 26 rulemaking, the NRC staff indicated that they reviewed the proposed 

alternative to rulemaking that would add fatigue measures for security officers at Category 1 

facilities and will request the Commission to terminate this rulemaking. If the Commission does 

not terminate this rulemaking, the staff will need to submit the regulatory basis to the Office of 

Nuclear Material Safety and Safeguards in February 2016. 

The NRC staff and industry also discussed non-rulemaking activities associated with the 

integrated schedule. The staff stated that the GL was completed and issued on June 22, 2015. 

The GL requested responses from the licensees by September 22, 2015. The staff indicated 

that the ISG on natural phenomena hazards was issued on June 26, 2015, and the Federal 

Register was published on June 7, 2015. 

The NRC staff committed to review the information on the integrated schedule and supplement, 

and to post these documents on the public website available at: 

http://www.nrc.gov/materials/fuelcycle-fac/regs-guides-comm.html#cumeffects. The supplement 

to the integrated schedule was revised after the meeting to indicate that the DG-5049, 

“Independent Assessment of Nuclear Material Control and Accounting Systems,” was issued for 

public comment on September 17, 2015, with a 60-day comment period ending on 

November 16, 2015. The slides for the meeting presentation are included in Enclosure 1 and 

the attendees list is available in Enclosure 2. Enclosure 3 is the fuel cycle integrated schedule, 

and Enclosure 4 is the supplement to that schedule. No regulatory decisions or commitments 

were made during the meeting. 

Revised Fuel Cycle Oversight Process 

The RFCOP presentation provided a status on current progress and plans for future 

development. The NRC staff presented an update on the RFCOP cornerstones, which will be 
M. Bailey 3 

submitted to the Commission for approval in January 2016. The significance determination 

process development is on schedule. The staff have developed draft screening questions to 

logically screen more-than-minor performance deficiencies to very low safety significance and 

continue to conceptually develop the framework for the cornerstone-specific risk evaluation 

guidance. The staff also shared concepts that will need to be developed to support changes to 

the performance assessment and inspection programs. 

 

The staff highlighted that an effective corrective action program (CAP) which is a prerequisite to 

participate in the RFCOP. And for those licensees that have an effective CAP it would be 

appropriate to reduce the core inspection effort (e.g., extend the frequency of inspections) in 

some areas, because the licensee would be expected to effectively self-identify and correct 

problems. Overall, the industry indicated that the RFCOP can provide benefits to both the NRC 

and industry through enhancements to the inspection, assessment, and significance 

determination programs. The staff plans on discussing potential options in changing the core 

inspection effort for licensees with an effective CAP at a public meeting in the spring of 2016. 

In addition, the staff and industry aligned on a draft definition of performance deficiency. The 

proposed definition states, "The licensee's failure to satisfy one or more regulatory requirement 

where the failure was reasonably foreseeable and preventable." Industry commented that the 

definition should be supported by examples or specific guidance to clarify the meaning of 

"reasonably foreseeable and preventable." 

Follow-up Discussion from Licensing and Inspection Program Roundtable at FCIX 2015 

During the 2015 Fuel Cycle Information Exchange (FCIX), NRC staff, representatives from NEI, 

and members of the industry had a roundtable discussion on best practices, areas of 

improvement, coordination, and industry perspectives on NRC’s licensing and inspection 

programs. Following the roundtable discussion at FCIX, the industry requested to further 

discuss several topics during this public meeting. During the follow-up meeting, the NRC staff 

addressed industry’s concerns related to both the inspection programs and licensing activities. 

Specifically, industry’s concerns were related to enhanced communication between the licensee 

and project managers (e.g., provide draft request for additional information [RAI] to the 

licensee), guidance on major vs minor license activities, clarification on items that are 

considered findings and observations, inspection schedule and coordination, and the re-exit 

process after an inspection is completed. 

During the discussion, NRC staff indicated that licensing project managers are already providing 

draft RAIs to licensees when appropriate and with the goal to institutionalize this in the next 

revision to NUREG-1520, “Standard Review Plan for Fuel Cycle Facilities License Applications.” 

Furthermore, NRC staff stated that guidance on 10 CFR Section 70.72 and Regulatory Guide 

3.74 is adequate and that the staff is not planning to develop additional guidance with regards to 

major and minor licensing actions. However, the NRC is open to supporting a licensing 

workshop if the fuel cycle industry request it in the future. With regards to the inspection 

program, the NRC staff indicated that RII management is working with the inspectors on 

expectation of items that are considered findings and the items that are considered 

observations; the issue should be resolved. 
M. Bailey 4 

In addition, the NRC staff indicated that they will consider the feasibility of the licensing project 

managers joining the Permanent Plant Modification Inspection with the purpose of integrating 

and following up on Integrated Safety Analysis summary update information related to 10 CFR 

70.72 changes. The NRC staff stated that the 2016 inspection schedule has been shared, and 

the goal for next year is to prepare the 2017 inspection schedule for 18 months and update the 

schedule on a quarterly basis. Finally, the NRC staff noted industry’s recommendation to 

consider providing licensees with the opportunity for input before “re-exit” and explained that 

inspections end with preliminary findings subject to management review. 

NEI Presentation on Fuel Cycle Facilities Cyber Security Rulemaking 

NEI provided a presentation on cyber security rulemaking. The presentation was focused on 

Category II and Category III fuel cycle facilities. NEI provided industry’s perspective preventing 

theft, diversion and sabotage, technical basis for requirements, and provided a high level 

discussion on the draft regulatory basis. The merits of the regulatory activities associated with 

the 10 CFR Part 73 Cyber Security Rulemaking were not discussed during this session. The 

NRC staff led a separate public meeting on September 23, 2015, to provide stakeholders the 

opportunity to discuss the draft Regulatory Basis for the proposed fuel cycle cyber security 

rulemaking, seek clarification on the document's content, and discuss comments. 

Enclosures: 

1. Slide Presentations for September 23, 2015 

 (ML15271A080) 

2. Attendees List (ML15275A082) 

3. CER (ML15272A099) 

4. Integrated Schedule (ML15272A109) 

cc: w/enclosures: Janet Schlueter 
M. Bailey 4 

In addition, the NRC staff indicated that they will consider the feasibility of the licensing project 

managers joining the Permanent Plant Modification Inspection with the purpose of integrating 

and following up on Integrated Safety Analysis summary update information related to 10 CFR 

70.72 changes. The NRC staff stated that the 2016 inspection schedule has been shared, and 

the goal for next year is to prepare the 2017 inspection schedule for 18 months and update the 

schedule on a quarterly basis. Finally, the NRC staff noted industry’s recommendation to 

consider providing licensees with the opportunity for input before “re-exit” and explained that 

inspections end with preliminary findings subject to management review. 

NEI Presentation on Fuel Cycle Facilities Cyber Security Rulemaking 

NEI provided a presentation on cyber security rulemaking. The presentation was focused on 

Category II and Category III fuel cycle facilities. NEI provided industry’s perspective preventing 

theft, diversion and sabotage, technical basis for requirements, and provided a high level 

discussion on the draft regulatory basis. The merits of the regulatory activities associated with 

the 10 CFR Part 73 Cyber Security Rulemaking were not discussed during this session. The 

NRC staff led a separate public meeting on September 23, 2015, to provide stakeholders the 

opportunity to discuss the draft Regulatory Basis for the proposed fuel cycle cyber security 

rulemaking, seek clarification on the document's content, and discuss comments. 

Enclosures: 

1. Slide Presentations for September 23, 2015 

 (ML15271A080) 

2. Attendees List (ML15275A082) 

3. CER (ML15272A099) 

4. Integrated Schedule (ML15272A109) 

cc: w/enclosures: Janet Schlueter 

DISTRIBUTION:

FCSE r/f 

ADAMS Accession No.:ML15275A100 Package No.:ML15275A191 

OFFICE FCSE/FMB FCSE/FMB FCSE/FMB 

NAME SSoto TBrockington RJohnson 

DATE 10/06/2015 10/08/2015 10/13/2015 

OFFICIAL USE ONLY