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{{#Wiki_filter:Title: Purpose: Scheduled:
{{#Wiki_filter:SCHEDULING NOTE
Duration:
 
Location:
==Title:==
SCHEDULING NOTE STRATEGIC PROGRAMMATIC OVERVIEW OF THE FUEL FACILITIES AND THE NUCLEAR MATERIALS USERS BUSINESS LINES (Public Meeting) The purpose of the briefing is to provide the Commission with a discussion of strategic considerations associated with the Fuel Facilities and the Nuclear Materials Users Business Lines. April 26, 2018 9:00 am Approx. 3 hours Commissioners' Conference Room, 1st floor OWFN Fuel Facilities Business Line 50 mins.* NRC Staff1 Victor McCree, Executive Director for Operations Marc Dapas, Director, Office of Nuclear Material Safety and Safeguards (NMSS) Topic:
STRATEGIC PROGRAMMATIC OVERVIEW OF THE FUEL FACILITIES AND THE NUCLEAR MATERIALS USERS BUSINESS LINES (Public Meeting)
 
==Purpose:==
The purpose of the briefing is to provide the Commission with a discussion of strategic considerations associated with the Fuel Facilities and the Nuclear Materials Users Business Lines.
Scheduled:              April 26, 2018 9:00 am Duration:                Approx. 3 hours Location:                Commissioners' Conference Room, 1st floor OWFN Fuel Facilities Business Line                                                                     50 mins.*
NRC Staff1 Victor McCree, Executive Director for Operations Marc Dapas, Director, Office of Nuclear Material Safety and Safeguards (NMSS)
Topic:
* Overview of the Fuel Facilities Business Line Craig Erlanger, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, NMSS Topic:
* Overview of the Fuel Facilities Business Line Craig Erlanger, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, NMSS Topic:
* Current Fuel Cycle Program Environment Eric Michel, Chief, Projects Branch 2, Division of Fuel Facility Inspection, RII Topic:
* Current Fuel Cycle Program Environment Eric Michel, Chief, Projects Branch 2, Division of Fuel Facility Inspection, RII Topic:
* Fuel Cycle Inspection Program Activities Brian Smith, Deputy Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, NMSS Topic:
* Fuel Cycle Inspection Program Activities Brian Smith, Deputy Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, NMSS Topic:
* NMSS/OCFO Fee Billing Project Update 1 Other business line partner office directors and regional *administrators will be located in the well as appropriate 1
* NMSS/OCFO Fee Billing Project Update 1 Other business line partner office directors and regional *administrators will be located in the well as appropriate 1
Commission Q & A Break Nuclear Materials Users Business Line NRC Staff2 Victor McCree, Executive Director for Operations Marc Dapas, Director, Office of Nuclear Material Safety and Safeguards (NMSS) Topic:
 
Commission Q & A                                                                                 30 mins.
Break                                                                                               5mins.
Nuclear Materials Users Business Line                                                             50 mins.*
NRC Staff2 Victor McCree, Executive Director for Operations Marc Dapas, Director, Office of Nuclear Material Safety and Safeguards (NMSS)
Topic:
* Overview of Nuclear Materials Users Business Line Kevin Williams, Acting Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Topic:
* Overview of Nuclear Materials Users Business Line Kevin Williams, Acting Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Topic:
* Current Materials Program Environment 30 mins. 5mins. 50 mins.* Aaron Mccraw, Chief, Materials Inspection Branch Division of Nuclear Materials Safety, RIii Topic:
* Current Materials Program Environment Aaron Mccraw, Chief, Materials Inspection Branch Division of Nuclear Materials Safety, RIii Topic:
* Regional Materials Licensing and Inspection Program Activities Linda Howell, Acting Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Topic:
* Regional Materials Licensing and Inspection Program Activities Linda Howell, Acting Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Topic:
* Emerging Medical Technologies Commission Q & A Discussion  
* Emerging Medical Technologies Commission Q & A                                                                                   30 mins.
-Wrap-Up 30 mins. 5mins. 2 Other business line partner office directors and regional administrators will be located in the well as appropriate 2
Discussion - Wrap-Up                                                                               5mins.
* -+ U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Fuel Facilities and Nuclear Materials Users Business Lines Commission Briefing April 26, 2018
2 Other business line partner office directors and regional administrators will be located in the well as appropriate 2
..
 
* 7 U.S.NRC Un i ted States Nuclear Regulatory Commission Protecting People and the Environment Opening Remarks Victor M. Mccree Executive Director for Operations
* -+
.. Fuel Facilities Business Line Meeting Agenda:
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Fuel Facilities and Nuclear Materials Users Business Lines Commission Briefing April 26, 2018
* Business Line Overview -Marc Dapas
 
* Current Program Environment  
7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Opening Remarks Victor M. Mccree Executive Director for Operations
-Cra*ig Erlanger
 
* Inspection Program Activities  
Fuel Facilities Business Line Meeting Agenda:
-Eric Michel
* Business Line Overview -
* Fee Billing Project Update -Brian Smith 3
Marc Dapas
' *
* Current Program Environment -
* 7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Overview of the Fuel Facilities Business Line Marc Dapas, Director Office of Nuclear Material Safety and Safeguards
Cra*ig Erlanger
..
* Inspection Program Activities -
* Focusing on Our Priorities
Eric Michel
* Fee Billing Project Update -
Brian Smith 3
 
7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Overview of the Fuel Facilities Business Line Marc Dapas, Director Office of Nuclear Material Safety and Safeguards
 
Focusing on Our Priorities
* Ensuring safety and security through licensing, oversight, and environmental reviews
* Ensuring safety and security through licensing, oversight, and environmental reviews
* Supporting U.S. proliferation activities
* Supporting U.S. non-proliferation activities
* Maintaining effective communications with stakeholders on regulatory activities 5
* Maintaining effective communications with stakeholders on regulatory activities 5
** Location of Fuel Cycle Facilities WY co
 
* Uranium Hexaf l uoride Con ersion Facility ( l) Uranium Fuel Fabrication Facility 5) Mixed-Oxide F e l Fa brication Fac11tty (1) ND so NE KS IA RI NJ DE MO DC Gas Centrifuge Uranium Enrichment Facility 14)
Location of Fuel Cycle Facilities ND so WY RI IA                                                NJ NE DE co                                                                               MO KS                                                            DC
* Laser Separatio n Enr chment Facility 11 Uranium Hexa fluor.de Deconversmn Fac ility 11)
* Uranium Hexafluoride Con ersion Facility (l)                           Gas Centrifuge Uranium Enrichment Facility 14)
* L ead Cascade facility used for t esting , is currently transition i ng to decommissioning. 6 Proactively Addressing Related Challenges
* Uranium Fuel Fabrication Facility 5)                                   Laser Separation Enr chment Facility 11 Mixed-Oxide F el Fabrication Fac11tty (1)                               Uranium Hexafluor.de Deconversmn Facility 11)
* Lead Cascade facility used for testing, is currently transition ing to decommissioning.
6
 
Proactively Addressing Fee-Related Challenges
* Performed an evaluation of the Nuclear Materials and Waste Safety program and fee classes
* Performed an evaluation of the Nuclear Materials and Waste Safety program and fee classes
* Initiated stakeholder outreach on potential improvements to the Fuel Facilities fee class annual fee calculation methodology 7
* Initiated stakeholder outreach on potential improvements to the Fuel Facilities fee class annual fee calculation methodology 7
Addressing the Changing Workload Fuel Facilities Business Line -FTE Levels FV2008-FV2018 190 1 84 180 170 160 w I-u.. 150 "C QI ... QI 140 :I ca 130 120 110 100 FY08 E N FY10 EN FY12 EN FY14 EN FY16 EN FY18 EN 8 Successfully Completed Post-Fukushima Activities
 
* Completed all activities involving Generic Letter 2015-01, ''Treatment of Natural Phenomena Hazards at Fuel Cycle Facilities''
Addressing the Changing Workload Fuel Facilities Business Line - FTE Levels FV2008-FV2018 190 184 180 170 160 w
I-u.. 150 "C
QI QI
~ 140
:I ca 130 120 110 100 FY08 EN        FY10 EN       FY12 EN       FY14 EN     FY16 EN FY18 EN 8
 
Successfully Completed Post-Fukushima Activities
* Completed all activities involving Generic Letter 2015-01,
  ''Treatment of Natural Phenomena Hazards at Fuel Cycle Facilities''
* Confirmed that licensees are in compliance with existing regulatory requirements
* Confirmed that licensees are in compliance with existing regulatory requirements
* Achieved safety and regulatory improvements 9
* Achieved safety and regulatory improvements 9
Providing Outreach and Education Opportunities on Safety Culture
Providing Outreach and Education Opportunities on Safety Culture
* Outreach:  
* Outreach:
-Presented at 2017 FCIX
    - Presented at 2017 FCIX
* Educational Tools: -NRC's Safety Culture Webpage and Educational Resource Workbook *
* Educational Tools:
* Addressing safety culture through our Alternative Dispute Resolution Program 10 I , 7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Current Fuel Cycle Program Environment Craig Erlanger, Director Division of Fuel Cycle Safety, Safeguards, and Environmental Review, NMSS Making Significant Progress on Several Regulatory Initiatives
    - NRC's Safety Culture Webpage and Educational Resource Workbook
* Rulemakings:  
*
-Cyber Security for Fuel Cycle Facilities  
* Addressing safety culture through our Alternative Dispute Resolution Program 10
-Modified Small Quantities Protocol
 
* Westinghouse Lessons-Learned initiative 12 Focusing on the Anticipated Licensing Workload 160 VI Z 140 0 6 120 <( C, z 100 VI z 80 LU u ::i C 60 LI.I I-LU 40 ..J C. 0 20 u 0 149 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 FISCAL YEAR 13 Successfully Implementing the Licensing and Oversight Programs
I ,
7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Current Fuel Cycle Program Environment Craig Erlanger, Director Division of Fuel Cycle Safety, Safeguards, and Environmental Review, NMSS
 
Making Significant Progress on Several Regulatory Initiatives
* Rulemakings:
  - Cyber Security for Fuel Cycle Facilities
  - Modified Small Quantities Protocol
* Westinghouse Lessons-Learned initiative 12
 
Focusing on the Anticipated Licensing Workload 160                     149 VI Z 140 0
6 120
<(
C, z 100 VI z
u 80 LU
::i C
LI.I 60 I-LU
..J C. 40
~
0     20 u
0 2009 2010 2011 2012 2013 2014   2015 2016 2017 2018 2019 2020 FISCAL YEAR 13
 
Successfully Implementing the Licensing and Oversight Programs
* Performed internal licensing process reviews
* Performed internal licensing process reviews
* Implemented enhancements to the licensing program
* Implemented enhancements to the licensing program
* Continued to leverage operating experience to improve the oversight program 14
* Continued to leverage operating experience to improve the oversight program 14
------------Successfully Implementing the Licensing and Oversight Programs
 
Successfully Implementing the Licensing and Oversight Programs
* Revised 3 Inspection Manual Chapters and 6 inspection procedures
* Revised 3 Inspection Manual Chapters and 6 inspection procedures
* Con,pleted enhancements to the Security Core Inspection Progran,
* Con,pleted enhancements to the Security Core Inspection Progran,
* Continued to lead the NRC material control and accounting progran, 15 Positively Impacting Regulatory Activities through Stakeholder Outreach FCIX 16 Successfully Implementing the International Safeguards Program
* Continued to lead the NRC material control and accounting progran, 15
 
Positively Impacting Regulatory Activities through Stakeholder Outreach FCIX 16
 
Successfully Implementing the International Safeguards Program
* Ensuring that the U.S. Government can meet its obligations under international agreements and treaties
* Ensuring that the U.S. Government can meet its obligations under international agreements and treaties
* Supporting efficient and accurate reporting for nuclear 111aterials and export-import licensing
* Supporting efficient and accurate reporting for nuclear 111aterials and export-import licensing
* Effectively engaging ,Nith Federal partners and interagency groups 17 Focusing on Future Opportunities
* Effectively engaging ,Nith Federal partners and interagency groups 17
 
Focusing on Future Opportunities
* Improving the accuracy of fee billing
* Improving the accuracy of fee billing
* Continuing stakeholder engagement on the Fuel Facilities Effort Factors Matrix
* Continuing stakeholder engagement on the Fuel Facilities Effort Factors Matrix
* Ensuring effective reorganization of FCSE
* Ensuring effective reorganization of FCSE
* Continuing to support our partner offices
* Continuing to support our partner offices
* Ensuring effective implementation of the current licensing and oversight programs 18 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Fuel Cycle Inspection Program Eric Michel, Chief Projects Branch 2 Division of Fuel Facility Inspection, Region II Effectively Implementing the Oversight Program
* Ensuring effective implementation of the current licensing and oversight programs 18
* Completed c*ore Inspection Program
 
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Fuel Cycle Inspection Program Eric Michel, Chief Projects Branch 2 Division of Fuel Facility Inspection, Region II
 
Effectively Implementing the Oversight Program
* Completed c *o re Inspection Program
* Performed a reactive special inspection at the BWXT Nuclear Operations Group
* Performed a reactive special inspection at the BWXT Nuclear Operations Group
* Conducted plant specific follow up inspections
* Conducted plant specific follow up inspections
* Completed* two alternative dispute resolution sessions 20 Enhancing the Oversight
* Completed *two alternative dispute resolution sessions 20
 
Enhancing the Oversight
* Program
* Program
* Proposed shifting some regional inspection activities to the senior resident inspectors at Category 1 fuel cycle facilities
* Proposed shifting some regional inspection activities to the senior resident inspectors at Category 1 fuel cycle facilities
* Conducted an inspection program gap analysis follo,Ning recent events resulting in escalated enforcement actions 21 Effectively Overseeing the Mixed Oxide Fuel Fabrication Facility
* Conducted an inspection program gap analysis follo,Ning recent events resulting in escalated enforcement actions 21
 
Effectively Overseeing the Mixed Oxide Fuel Fabrication Facility
* Completed 1768 hours of inspection activities
* Completed 1768 hours of inspection activities
* Completed 2 o*f 53 principal systems, structures, and . components verifications
* Completed 2 o*f 53 principal systems, structures, and
* Return of licensee to Column 1 of the Construction Action Matrix 22 Continued Oversight of the Westinghouse Columbia Scrubber Condition
. components verifications
* Return of licensee to Column 1 of the Construction Action Matrix 22
 
Continued Oversight of the Westinghouse Columbia Scrubber Condition
* Closed the Confirmatory Action Letter
* Closed the Confirmatory Action Letter
* Identified an Area Needing Improvement and issued a Confirmatory Order
* Identified an Area Needing Improvement and issued a Confirmatory Order
* Conducted additional inspection activities 23 Focusing on the Future of the Oversight Program
* Conducted additional inspection activities 23
 
Focusing on the Future of the Oversight Program
* Ensuring strong collaboration with headquarters offices
* Ensuring strong collaboration with headquarters offices
* Continuing to leverage Communities of Practice to enhance knowledge management
* Continuing to leverage Communities of Practice to enhance knowledge management
* Encouraging cross-qualification and support of other divisions within Region II 24 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment NMSS/OCFO Fee Billing Project Update Brian Smith, Deputy Director Division of Fuel Cycle Safety, Safeguards, and Environmental Review, NMSS Improving the Accuracy of Fee Billing
* Encouraging cross-qualification and support of other divisions within Region II 24
 
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment NMSS/OCFO Fee Billing Project Update Brian Smith, Deputy Director Division of Fuel Cycle Safety, Safeguards, and Environmental Review, NMSS
 
Improving the Accuracy of Fee Billing
* Identified fee billing errors across all NMWS business lines
* Identified fee billing errors across all NMWS business lines
* Established a joint NMSS/OCFO team
* Established a joint NMSS/OCFO team
* Developed a project plan and identified areas for improvement
* Developed a project plan and identified areas for improvement
* Prioritized tasks into phases
* Prioritized tasks into phases
* On schedule to complete all tasks-this fiscal year 26 Significant Accomplishments Achieved
* On schedule to complete all tasks-this fiscal year 26
 
Significant Accomplishments Achieved
* Completed WBL data review of high priority licenses
* Completed WBL data review of high priority licenses
* Consolidated licenses in WBL
* Consolidated licenses in WBL
* Enhanced FAIMIS and WBL interfaces to integrate with the Master Data Management System 27 Significant Accomplishments Achieved
* Enhanced FAIMIS and WBL interfaces to integrate with the Master Data Management System 27
 
Significant Accomplishments Achieved
* Established roles and responsibilities related to fee billing
* Established roles and responsibilities related to fee billing
* Established a decommissioning status change process
* Established a decommissioning status change process
* Performed internal and external stakeholder outreach 28
* Performed internal and external stakeholder outreach 28
. .
 
* Future Actions *
Future Actions
* Complete the review of the remaining license data in WBL ~nd system interface improvements
    * *Complete the review of the remaining license data in WBL
* Complete the tax identification number and billing address collection process for new licensees  
        ~nd system interface improvements
*
* Complete the tax identification number and billing address collection process for new licensees                 *
* Conduct training across NMSS and regional offices 29 I I Questions 30 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Nuclear Materials Users Business Line April 26, 2018
* Conduct training across NMSS and regional offices 29
*. U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Opening Remarks Victor M.* Mccree Executive Director for Operations
 
.. Nuclear Materials Users Business Line Meeting Agenda:
I I
Questions 30
 
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Nuclear Materials Users Business Line April 26, 2018
 
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Opening Remarks Victor M.* Mccree Executive Director for Operations
 
Nuclear Materials Users Business Line Meeting Agenda:
* Overview of Nuclear Materials Users Business Line
* Overview of Nuclear Materials Users Business Line
* Current National Materials Program Environment
* Current National Materials Program Environment
* Regional Materials Licensing and Inspection Program Activities
* Regional Materials Licensing and Inspection Program Activities
* Emerging Medical Technologies 33
* Emerging Medical Technologies 33
*, U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Overview of Nuclear Materials Users Business Line Marc Dapas, Director Office of Nuclear Material Safety and Safeguards
 
' . Ensuring Safety Over a Broad Range of Activities
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Overview of Nuclear Materials Users Business Line Marc Dapas, Director Office of Nuclear Material Safety and Safeguards
 
Ensuring Safety Over a Broad Range of Activities
* Communicating and coordinating with stakeholders to ensure external factors are identified and considered
* Communicating and coordinating with stakeholders to ensure external factors are identified and considered
* The Nuclear Materials Users business line consists of 223 FTE and $22. 7. million in contract support and travel 35 Focusing on Several High Priority Items
* The Nuclear Materials Users business line consists of 223 FTE and $22. 7. million in contract support and travel 35
 
Focusing on Several High Priority Items
* Supporting the Government Accountability Office's Engagement on Effectiveness of 10 CFR Part 37
* Supporting the Government Accountability Office's Engagement on Effectiveness of 10 CFR Part 37
* Participating in the Office of Inspector General's Audit of the National Materials Program
* Participating in the Office of Inspector General's Audit of the National Materials Program
* Reviewing the Wyoming and Vermont Agreement State draft applications 36 Focusing on Several High Priority Items
* Reviewing the Wyoming and Vermont Agreement State draft applications 36
 
Focusing on Several High Priority Items
* Engaging Native American Tribes
* Engaging Native American Tribes
* Organizing several State Liaison Officers Program Activities 37
* Organizing several State Liaison Officers Program Activities 37
....-----------------
 
~--U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Current National Materials Program Environment Kevin Williams, Acting Director Division of Materials Safety, Security, State, and Tribal Programs, NMSS Ensuring Safety and Security under the National Materials Program
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Current National Materials Program Environment Kevin Williams, Acting Director Division of Materials Safety, Security, State, and Tribal Programs, NMSS
 
Ensuring Safety and Security under the National Materials Program
* Over 19,300 specific licensees
* Over 19,300 specific licensees
* Agreement States regulate about 86&deg;/o
* Agreement States regulate about 86&deg;/o
* Number of materials licensees remains relatively stable 39 -------
* Number of materials licensees remains relatively stable 39
 
Effectively Engaging the Agreement States as Our Regulatory Partners
Effectively Engaging the Agreement States as Our Regulatory Partners
* Participating in working groups for guidance development and agency evaluation of regulatory approaches
* Participating in working groups for guidance development and agency evaluation of regulatory approaches
* Organizing pe~iodic meetings and calls to cover a wide range of regulatory topics
* Organizing pe~iodic meetings and calls to cover a wide range of regulatory topics
* Collaborating on non-military, related activities 40 Engaging with Wyoming on Its Agreement State Application
* Collaborating on non-military, radium-related activities 40
 
Engaging with Wyoming on Its Agreement State Application
* Letter of Intent submitted to become an Agreement State in 2015, follo\Ned by a Draft Application in 2016
* Letter of Intent submitted to become an Agreement State in 2015, follo\Ned by a Draft Application in 2016
* Wyoming Proposed a Limited Agreement for uranium recovery programs
* Wyoming Proposed a Limited Agreement for uranium recovery programs
* Staff \Nill request Commission approval to publish the results of the staff assessment and the proposed Agreement for public comment next month 41 Successfully Outreaching to Native American Tribes
* Staff \Nill request Commission approval to publish the results of the staff assessment and the proposed Agreement for public comment next month 41
 
Successfully Outreaching to Native American Tribes
* Established cooperative relationship with the Catawba Indian Nation
* Established cooperative relationship with the Catawba Indian Nation
* Supporting uranium contamination clean-up in the Navajo Nation
* Supporting uranium contamination clean-up in the Navajo Nation
* Providing in person* health physics training to the Tribes and making training material available online 42
* Providing in person* health physics training to the Tribes and making training material available online 42
* ... Working Collaboratively on the Radiation Protection and Security Task Force
 
Working Collaboratively on the Radiation Protection and Security Task Force
* The Task Force was established to provide recommendations relating to the security of radioactive sources in the US
* The Task Force was established to provide recommendations relating to the security of radioactive sources in the US
* Coordinating with the Task Force member agencies on the status of existing recommendations and developing new recommendations
* Coordinating with the Task Force member agencies on the status of existing recommendations and developing new recommendations
* NRC will submit to the President and Congress the 4th Task Force Report in
* NRC will submit to the President and Congress the 4th Task Force Report in
* August 2018 43
* August 2018 43
\.. Completed the Cyber Security Evaluation for Byproduct
 
* Materials Licensees
\..
Completed the Cyber Security Evaluation for Byproduct
          *Materials Licensees
* Determined that the cu~rent cyber security threat environment does not vvarrant nevv regulations
* Determined that the cu~rent cyber security threat environment does not vvarrant nevv regulations
* Developing an lnforn,ation Notice to communicate effective practices for cyber security for risk-significant radioactive materials licensees
* Developing an lnforn,ation Notice to communicate effective practices for cyber security for risk-significant radioactive materials licensees
* The evaluation results \Nere posted on the NRC Public \Nebsite 44
* The evaluation results \Nere posted on the NRC Public \Nebsite 44
\_ Addressing the Source Security Program Review Recommendations Issued Regulatory Issue Summary (RIS) 2018-01, ''Common Violations cited during First 2 Years of 10 CFR Part 37, 'Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material,'
 
\_
Addressing the Source Security Program Review Recommendations Issued Regulatory Issue Summary (RIS) 2018-01, ''Common Violations cited during First 2 Years of 10 CFR Part 37, 'Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material,'
Implementation and Guidance Development Available to Support Rule Implementation''
Implementation and Guidance Development Available to Support Rule Implementation''
45 Addressing the Source Security Program Review Recommendations
45
* Drafted a revision to NUREG-2155, ''Implementation Guidance for 10 CFR Part 37, 'Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material'''
 
* Preparing a rulemaking plan to address recommendations 46 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Regional Materials Licensi*ng and Inspection Program Activities Aaron T. Mccraw, Chief, Materials Inspection Branch, Division of Nuclear Material Safety, Region Ill
Addressing the Source Security Program Review Recommendations
-. Creating Efficiencies Through the Agency's Rebaselining Initiative  
* Drafted a revision to NUREG-2155,
: 1) Limited scope revision to IMC 2800 -Changed routine inspection eligibility period to +/-50&deg;/o of assigned frequency  
  ''Implementation Guidance for 10 CFR Part 37, 'Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material'''
-Extended the initial inspection period for licensees that have not taken possession of any materials  
* Preparing a rulemaking plan to address recommendations 46
-Allowed inspection interval extensions for good performance on a case-by-case basis 2) Extended renewals from 10 to 15 years 3) Centralized bankruptcy reviews in NMSS 48
 
* Looking on the Horizon for Additional Efficiencies .
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Regional Materials Licensi*n g and Inspection Program Activities Aaron T. Mccraw, Chief, Materials Inspection Branch, Division of Nuclear Material Safety, Region Ill
* Further risk-inform inspection frequencies
 
Creating Efficiencies Through the Agency's Rebaselining Initiative
: 1) Limited scope revision to IMC 2800
      - Changed routine inspection eligibility period to +/-50&deg;/o of assigned frequency
      - Extended the initial inspection period for licensees that have not taken possession of any materials
      - Allowed inspection interval extensions for good performance on a case-by-case basis
: 2) Extended renewals from 10 to 15 years
: 3) Centralized bankruptcy reviews in NMSS 48
 
Looking on the Horizon for Additional Efficiencies
  .* Further risk-inform inspection frequencies
* Evaluate requirements for
* Evaluate requirements for
* inspections at locations of use
* inspections at locations of use
* Review reciprocity inspection metrics
* Review reciprocity inspection metrics
* Enhance inspection documentation 49
* Enhance inspection documentation 49
.. Regional Materials Staff in Action 50 Regional Materials Staff in Action 51 Tracking Trends in Allegations and Enforcement
 
Regional Materials Staff in Action 50
 
Regional Materials Staff in Action 51
 
Tracking Trends in Allegations and Enforcement
* Workload continues to be stable
* Workload continues to be stable
* No notable trends in allegations
* No notable trends in allegations
* Escalated enforcement cases continue to involve gauge security and Part 37 52 Transforming Enforcement of Portable Gauge Security Violations
* Escalated enforcement cases continue to involve gauge security and Part 37 52
 
Transforming Enforcement of Portable Gauge Security Violations
* Opportunity to further risk-inform the
* Opportunity to further risk-inform the
* enforcement process and consider:  
* enforcement process and consider:
-Location of use -Duration of the lapse in surveillance  
  - Location of use
-Whether damage occurred 53 Adapting to Advancements in Security Technology
  - Duration of the lapse in surveillance
  - Whether damage occurred 53
 
Adapting to Advancements in Security Technology
* Regional materials inspectors are uniquely positioned to observe new advancements in security technology
* Regional materials inspectors are uniquely positioned to observe new advancements in security technology
* Ne,N technologies do not necessarily guarantee compliance V#ith Part 37
* Ne,N technologies do not necessarily guarantee compliance V#ith Part 37
* Working to evaluate regulations that *may inadvertently discourage ne,N technologies 54
* Working to evaluate regulations that
.. U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Emerging Medical Technologies Linda Howell, Acting Deputy Director Division of Materials Safety, Security, State, and Tribal Programs, NMSS
  *may inadvertently discourage ne,N technologies 54
* 1
 
* NRC's Outreach and Process for Evaluating Emerging Medical Technology
U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Emerging Medical Technologies Linda Howell, Acting Deputy Director Division of Materials Safety, Security, State, and Tribal Programs, NMSS
* 1 NRC's Outreach and Process for Evaluating Emerging Medical Technology
* NRC staff engages numerous stakeholders to maintain awareness of any emerging medical technology
* NRC staff engages numerous stakeholders to maintain awareness of any emerging medical technology
* While developing the standard license conditions for emerging technologies, the staff continues to engage_ internal and external stakeholders 56
* While developing the standard license conditions for emerging technologies, the staff continues to engage_internal and external stakeholders 56
. Continuing Efforts to Evaluate Emerging Medical Technologies
 
. ~
Continuing Efforts to Evaluate Emerging Medical Technologies
* NRC staff submitted a SECY paper on emerging technologies, providing an estimate of the staff resources needed to develop licensing guidance
* NRC staff submitted a SECY paper on emerging technologies, providing an estimate of the staff resources needed to develop licensing guidance
* NRC staff will continue to engage its stakeholders in determining the regulatory needs for emerging medical technology 57
* NRC staff will continue to engage its stakeholders in determining the regulatory needs for emerging medical technology 57
** Anticipating Future Staff Reviews For Emerging Medical Technologies  
 
*
Anticipating Future Staff Reviews For Emerging Medical Technologies *
* Phosphorus-32 Oncosil microparticles
* Phosphorus-32 Oncosil microparticles
* MASEP lnfini cobalt-60 stereotactic radiosurgery .
* MASEP lnfini cobalt-60 stereotactic radiosurgery
* GammaPod cobalt-60 stereotactic radiotherapy
  .* GammaPod cobalt-60 stereotactic radiotherapy
* Iodine -131 radiolabeled monoclonal antibody
* Iodine -131 radiolabeled monoclonal antibody
* Thorium processed into lead-212 58 Yttrium-90 Microsphere Brachytherapy Events SIRSpheres
* Thorium processed into lead-212 58
* TheraSphere 59
 
., Catheter Placement Pre-treatment Image 60 Post-Treatment Imaging Yttrium-90 SPECT Yttrium-90 SPECT / CT Yttrium-90 PET/CT Yttrium-90 PET/MRI 61
Yttrium-90 Microsphere Brachytherapy Events SIRSpheres
* TheraSphere 59
 
Catheter Placement Pre-treatment Image 60
 
Post-Treatment Imaging Yttrium-90 SPECT Yttrium-90 SPECT / CT Yttrium-90 PET/CT Yttrium-90 PET/MRI 61
* l Evaluating Reported Yttrium-90 Medical Events
* l Evaluating Reported Yttrium-90 Medical Events
* Staff asked .INL to perform a case study on Yttrium-90 microsphere events over the past 10 years
* Staff asked .I NL to perform a case study on Yttrium-90 microsphere events over the past 10 years
* Since Yttrium-90 treatments began (15 years ago), the numbers of medical events have increased
* Since Yttrium-90 treatments began (15 years ago), the numbers of medical events have increased
* The increase in reported medical events is commensurate vvith the increase in use of Yttrium-90 microspheres 62
* The increase in reported medical events is commensurate vvith the increase in use of Yttrium-90 microspheres 62
. , The Staff Did Not Identify a Negative Performance Trend
 
* Based on the INL re.port and analysis of the trending data, the staff did not find a negative performance trend or gaps in NRC regulations
The Staff Did Not Identify a Negative Performance Trend
* Though no negative trends were identified at this time, it is beneficial to question our regulations to determine what is adequate when it comes to evolving medical technologies 63 Questions 64
* Based on the INL re.p ort and analysis of the trending data, the staff did not find a negative performance trend or gaps in NRC regulations
* Though no negative trends were identified at this time, it is beneficial to question our regulations to determine what is adequate when it comes to evolving medical technologies 63
 
Questions 64
 
, 'l List of Acronyms
, 'l List of Acronyms
* ACMUI -Advisory Committee on Medical Uses of Isotopes
* ACMUI -Advisory Committee on Medical Uses of Isotopes
* CER -Cumulative Effects of Regulation
* CER - Cumulative Effects of Regulation
* CFR -Code of Federal Regulations
* CFR - Code of Federal Regulations
* CRCPD -Conference of Radiation Control Program Directors
* CRCPD - Conference of Radiation Control Program Directors
* FAIMIS -Financial Accounting and Integrated Management Information System
* FAIMIS - Financial Accounting and Integrated Management Information System
* FCIX -Fuel Cycle Information Exchange
* FCIX - Fuel Cycle Information Exchange
* FCSE -Division of Fuel Cycle Safety, Safeguards and Environmental Review
* FCSE - Division of Fuel Cycle Safety, Safeguards and Environmental Review
* FDA -Food and Drug Administration
* FDA - Food and Drug Administration
* FTE -Full Time Equivalent 65 List of Acronyms
* FTE - Full Time Equivalent 65
* GAO -Government Accountability Office
 
* IMC -Inspection Manual Chapter
List of Acronyms
* INL -Idaho National Laboratory
* GAO - Government Accountability Office
* MDMS-Master Data Management System
* IMC - Inspection Manual Chapter
* NMSS -Office of Nuclear Materi*al Safety and Safeguards
* INL - Idaho National Laboratory
* NMU -Nuclear Materials Users
* MDMS- Master Data Management System
* NMWS -Nuclear Materials and Waste Safety
* NMSS - Office of Nuclear Materi*a l Safety and Safeguards
* NORM -Naturally Occurring Radioactive Material 66 List of Acronyms
* NMU - Nuclear Materials Users
* NRC -Nuclear Regulatory Commission
* NMWS - Nuclear Materials and Waste Safety
* OAS -Organization of Agreement States
* NORM - Naturally Occurring Radioactive Material 66
* OCFO -Office of the Chief Financial Officer
 
* OIG -Office of Inspector General
List of Acronyms
* SLO -State Liaison Officer
* NRC - Nuclear Regulatory Commission
* RIC -Regulatory ln*formation Conference
* OAS - Organization of Agreement States
* OCFO -Office of the Chief Financial Officer
* OCFO - Office of the Chief Financial Officer
* WBL -Web-Based Licensing 67}}
* OIG - Office of Inspector General
* SLO - State Liaison Officer
* RIC - Regulatory ln*f ormation Conference
* OCFO - Office of the Chief Financial Officer
* WBL - Web-Based Licensing 67}}

Latest revision as of 04:15, 3 February 2020

M180426: Scheduling Note and Slides - Strategic Programmatic Overview of the Fuel Facilities and the Nuclear Materials Users Business Lines (Public Meeting)
ML18114A319
Person / Time
Issue date: 04/26/2018
From:
NRC/SECY
To:
References
M180426
Download: ML18114A319 (69)


Text

SCHEDULING NOTE

Title:

STRATEGIC PROGRAMMATIC OVERVIEW OF THE FUEL FACILITIES AND THE NUCLEAR MATERIALS USERS BUSINESS LINES (Public Meeting)

Purpose:

The purpose of the briefing is to provide the Commission with a discussion of strategic considerations associated with the Fuel Facilities and the Nuclear Materials Users Business Lines.

Scheduled: April 26, 2018 9:00 am Duration: Approx. 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> Location: Commissioners' Conference Room, 1st floor OWFN Fuel Facilities Business Line 50 mins.*

NRC Staff1 Victor McCree, Executive Director for Operations Marc Dapas, Director, Office of Nuclear Material Safety and Safeguards (NMSS)

Topic:

  • Overview of the Fuel Facilities Business Line Craig Erlanger, Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, NMSS Topic:
  • Current Fuel Cycle Program Environment Eric Michel, Chief, Projects Branch 2, Division of Fuel Facility Inspection, RII Topic:
  • Fuel Cycle Inspection Program Activities Brian Smith, Deputy Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, NMSS Topic:
  • NMSS/OCFO Fee Billing Project Update 1 Other business line partner office directors and regional *administrators will be located in the well as appropriate 1

Commission Q & A 30 mins.

Break 5mins.

Nuclear Materials Users Business Line 50 mins.*

NRC Staff2 Victor McCree, Executive Director for Operations Marc Dapas, Director, Office of Nuclear Material Safety and Safeguards (NMSS)

Topic:

  • Overview of Nuclear Materials Users Business Line Kevin Williams, Acting Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Topic:
  • Current Materials Program Environment Aaron Mccraw, Chief, Materials Inspection Branch Division of Nuclear Materials Safety, RIii Topic:
  • Regional Materials Licensing and Inspection Program Activities Linda Howell, Acting Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Topic:
  • Emerging Medical Technologies Commission Q & A 30 mins.

Discussion - Wrap-Up 5mins.

2 Other business line partner office directors and regional administrators will be located in the well as appropriate 2

  • -+

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Fuel Facilities and Nuclear Materials Users Business Lines Commission Briefing April 26, 2018

7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Opening Remarks Victor M. Mccree Executive Director for Operations

Fuel Facilities Business Line Meeting Agenda:

  • Business Line Overview -

Marc Dapas

  • Current Program Environment -

Cra*ig Erlanger

  • Inspection Program Activities -

Eric Michel

  • Fee Billing Project Update -

Brian Smith 3

7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Overview of the Fuel Facilities Business Line Marc Dapas, Director Office of Nuclear Material Safety and Safeguards

Focusing on Our Priorities

  • Ensuring safety and security through licensing, oversight, and environmental reviews
  • Supporting U.S. non-proliferation activities
  • Maintaining effective communications with stakeholders on regulatory activities 5

Location of Fuel Cycle Facilities ND so WY RI IA NJ NE DE co MO KS DC

  • Uranium Fuel Fabrication Facility 5) Laser Separation Enr chment Facility 11 Mixed-Oxide F el Fabrication Fac11tty (1) Uranium Hexafluor.de Deconversmn Facility 11)
  • Lead Cascade facility used for testing, is currently transition ing to decommissioning.

6

Proactively Addressing Fee-Related Challenges

  • Performed an evaluation of the Nuclear Materials and Waste Safety program and fee classes
  • Initiated stakeholder outreach on potential improvements to the Fuel Facilities fee class annual fee calculation methodology 7

Addressing the Changing Workload Fuel Facilities Business Line - FTE Levels FV2008-FV2018 190 184 180 170 160 w

I-u.. 150 "C

QI QI

~ 140

I ca 130 120 110 100 FY08 EN FY10 EN FY12 EN FY14 EN FY16 EN FY18 EN 8

Successfully Completed Post-Fukushima Activities

Treatment of Natural Phenomena Hazards at Fuel Cycle Facilities

  • Confirmed that licensees are in compliance with existing regulatory requirements
  • Achieved safety and regulatory improvements 9

Providing Outreach and Education Opportunities on Safety Culture

  • Outreach:

- Presented at 2017 FCIX

  • Educational Tools:

- NRC's Safety Culture Webpage and Educational Resource Workbook

  • Addressing safety culture through our Alternative Dispute Resolution Program 10

I ,

7 U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Current Fuel Cycle Program Environment Craig Erlanger, Director Division of Fuel Cycle Safety, Safeguards, and Environmental Review, NMSS

Making Significant Progress on Several Regulatory Initiatives

  • Rulemakings:

- Cyber Security for Fuel Cycle Facilities

- Modified Small Quantities Protocol

  • Westinghouse Lessons-Learned initiative 12

Focusing on the Anticipated Licensing Workload 160 149 VI Z 140 0

6 120

<(

C, z 100 VI z

u 80 LU

i C

LI.I 60 I-LU

..J C. 40

~

0 20 u

0 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 FISCAL YEAR 13

Successfully Implementing the Licensing and Oversight Programs

  • Performed internal licensing process reviews
  • Implemented enhancements to the licensing program
  • Continued to leverage operating experience to improve the oversight program 14

Successfully Implementing the Licensing and Oversight Programs

  • Revised 3 Inspection Manual Chapters and 6 inspection procedures
  • Con,pleted enhancements to the Security Core Inspection Progran,
  • Continued to lead the NRC material control and accounting progran, 15

Positively Impacting Regulatory Activities through Stakeholder Outreach FCIX 16

Successfully Implementing the International Safeguards Program

  • Ensuring that the U.S. Government can meet its obligations under international agreements and treaties
  • Supporting efficient and accurate reporting for nuclear 111aterials and export-import licensing
  • Effectively engaging ,Nith Federal partners and interagency groups 17

Focusing on Future Opportunities

  • Improving the accuracy of fee billing
  • Continuing stakeholder engagement on the Fuel Facilities Effort Factors Matrix
  • Ensuring effective reorganization of FCSE
  • Continuing to support our partner offices
  • Ensuring effective implementation of the current licensing and oversight programs 18

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Fuel Cycle Inspection Program Eric Michel, Chief Projects Branch 2 Division of Fuel Facility Inspection, Region II

Effectively Implementing the Oversight Program

  • Completed c *o re Inspection Program
  • Performed a reactive special inspection at the BWXT Nuclear Operations Group
  • Conducted plant specific follow up inspections
  • Completed *two alternative dispute resolution sessions 20

Enhancing the Oversight

  • Program
  • Proposed shifting some regional inspection activities to the senior resident inspectors at Category 1 fuel cycle facilities
  • Conducted an inspection program gap analysis follo,Ning recent events resulting in escalated enforcement actions 21

Effectively Overseeing the Mixed Oxide Fuel Fabrication Facility

  • Completed 1768 hours0.0205 days <br />0.491 hours <br />0.00292 weeks <br />6.72724e-4 months <br /> of inspection activities
  • Completed 2 o*f 53 principal systems, structures, and

. components verifications

  • Return of licensee to Column 1 of the Construction Action Matrix 22

Continued Oversight of the Westinghouse Columbia Scrubber Condition

  • Closed the Confirmatory Action Letter
  • Identified an Area Needing Improvement and issued a Confirmatory Order
  • Conducted additional inspection activities 23

Focusing on the Future of the Oversight Program

  • Ensuring strong collaboration with headquarters offices
  • Continuing to leverage Communities of Practice to enhance knowledge management
  • Encouraging cross-qualification and support of other divisions within Region II 24

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment NMSS/OCFO Fee Billing Project Update Brian Smith, Deputy Director Division of Fuel Cycle Safety, Safeguards, and Environmental Review, NMSS

Improving the Accuracy of Fee Billing

  • Identified fee billing errors across all NMWS business lines
  • Established a joint NMSS/OCFO team
  • Developed a project plan and identified areas for improvement
  • Prioritized tasks into phases
  • On schedule to complete all tasks-this fiscal year 26

Significant Accomplishments Achieved

  • Completed WBL data review of high priority licenses
  • Consolidated licenses in WBL
  • Enhanced FAIMIS and WBL interfaces to integrate with the Master Data Management System 27

Significant Accomplishments Achieved

  • Established roles and responsibilities related to fee billing
  • Established a decommissioning status change process
  • Performed internal and external stakeholder outreach 28

Future Actions

  • *Complete the review of the remaining license data in WBL

~nd system interface improvements

  • Complete the tax identification number and billing address collection process for new licensees *
  • Conduct training across NMSS and regional offices 29

I I

Questions 30

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Nuclear Materials Users Business Line April 26, 2018

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Opening Remarks Victor M.* Mccree Executive Director for Operations

Nuclear Materials Users Business Line Meeting Agenda:

  • Overview of Nuclear Materials Users Business Line
  • Current National Materials Program Environment
  • Regional Materials Licensing and Inspection Program Activities
  • Emerging Medical Technologies 33

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Overview of Nuclear Materials Users Business Line Marc Dapas, Director Office of Nuclear Material Safety and Safeguards

Ensuring Safety Over a Broad Range of Activities

  • Communicating and coordinating with stakeholders to ensure external factors are identified and considered
  • The Nuclear Materials Users business line consists of 223 FTE and $22. 7. million in contract support and travel 35

Focusing on Several High Priority Items

  • Supporting the Government Accountability Office's Engagement on Effectiveness of 10 CFR Part 37
  • Participating in the Office of Inspector General's Audit of the National Materials Program
  • Reviewing the Wyoming and Vermont Agreement State draft applications 36

Focusing on Several High Priority Items

  • Engaging Native American Tribes
  • Organizing several State Liaison Officers Program Activities 37

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Current National Materials Program Environment Kevin Williams, Acting Director Division of Materials Safety, Security, State, and Tribal Programs, NMSS

Ensuring Safety and Security under the National Materials Program

  • Over 19,300 specific licensees
  • Agreement States regulate about 86°/o
  • Number of materials licensees remains relatively stable 39

Effectively Engaging the Agreement States as Our Regulatory Partners

  • Participating in working groups for guidance development and agency evaluation of regulatory approaches
  • Organizing pe~iodic meetings and calls to cover a wide range of regulatory topics
  • Collaborating on non-military, radium-related activities 40

Engaging with Wyoming on Its Agreement State Application

  • Letter of Intent submitted to become an Agreement State in 2015, follo\Ned by a Draft Application in 2016
  • Wyoming Proposed a Limited Agreement for uranium recovery programs
  • Staff \Nill request Commission approval to publish the results of the staff assessment and the proposed Agreement for public comment next month 41

Successfully Outreaching to Native American Tribes

  • Established cooperative relationship with the Catawba Indian Nation
  • Supporting uranium contamination clean-up in the Navajo Nation
  • Providing in person* health physics training to the Tribes and making training material available online 42

Working Collaboratively on the Radiation Protection and Security Task Force

  • The Task Force was established to provide recommendations relating to the security of radioactive sources in the US
  • Coordinating with the Task Force member agencies on the status of existing recommendations and developing new recommendations
  • NRC will submit to the President and Congress the 4th Task Force Report in
  • August 2018 43

\..

Completed the Cyber Security Evaluation for Byproduct

  • Materials Licensees
  • Determined that the cu~rent cyber security threat environment does not vvarrant nevv regulations
  • Developing an lnforn,ation Notice to communicate effective practices for cyber security for risk-significant radioactive materials licensees
  • The evaluation results \Nere posted on the NRC Public \Nebsite 44

\_

Addressing the Source Security Program Review Recommendations Issued Regulatory Issue Summary (RIS) 2018-01, Common Violations cited during First 2 Years of 10 CFR Part 37, 'Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material,'

Implementation and Guidance Development Available to Support Rule Implementation

45

Addressing the Source Security Program Review Recommendations

Implementation Guidance for 10 CFR Part 37, 'Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material'

  • Preparing a rulemaking plan to address recommendations 46

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Regional Materials Licensi*n g and Inspection Program Activities Aaron T. Mccraw, Chief, Materials Inspection Branch, Division of Nuclear Material Safety, Region Ill

Creating Efficiencies Through the Agency's Rebaselining Initiative

1) Limited scope revision to IMC 2800

- Changed routine inspection eligibility period to +/-50°/o of assigned frequency

- Extended the initial inspection period for licensees that have not taken possession of any materials

- Allowed inspection interval extensions for good performance on a case-by-case basis

2) Extended renewals from 10 to 15 years
3) Centralized bankruptcy reviews in NMSS 48

Looking on the Horizon for Additional Efficiencies

.* Further risk-inform inspection frequencies

  • Evaluate requirements for
  • inspections at locations of use
  • Review reciprocity inspection metrics
  • Enhance inspection documentation 49

Regional Materials Staff in Action 50

Regional Materials Staff in Action 51

Tracking Trends in Allegations and Enforcement

  • Workload continues to be stable
  • No notable trends in allegations
  • Escalated enforcement cases continue to involve gauge security and Part 37 52

Transforming Enforcement of Portable Gauge Security Violations

  • Opportunity to further risk-inform the
  • enforcement process and consider:

- Location of use

- Duration of the lapse in surveillance

- Whether damage occurred 53

Adapting to Advancements in Security Technology

  • Regional materials inspectors are uniquely positioned to observe new advancements in security technology
  • Ne,N technologies do not necessarily guarantee compliance V#ith Part 37
  • Working to evaluate regulations that
  • may inadvertently discourage ne,N technologies 54

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Emerging Medical Technologies Linda Howell, Acting Deputy Director Division of Materials Safety, Security, State, and Tribal Programs, NMSS

  • 1 NRC's Outreach and Process for Evaluating Emerging Medical Technology
  • NRC staff engages numerous stakeholders to maintain awareness of any emerging medical technology
  • While developing the standard license conditions for emerging technologies, the staff continues to engage_internal and external stakeholders 56

. ~

Continuing Efforts to Evaluate Emerging Medical Technologies

  • NRC staff submitted a SECY paper on emerging technologies, providing an estimate of the staff resources needed to develop licensing guidance
  • NRC staff will continue to engage its stakeholders in determining the regulatory needs for emerging medical technology 57

Anticipating Future Staff Reviews For Emerging Medical Technologies *

  • Phosphorus-32 Oncosil microparticles
  • MASEP lnfini cobalt-60 stereotactic radiosurgery

.* GammaPod cobalt-60 stereotactic radiotherapy

  • Iodine -131 radiolabeled monoclonal antibody

Yttrium-90 Microsphere Brachytherapy Events SIRSpheres

Catheter Placement Pre-treatment Image 60

Post-Treatment Imaging Yttrium-90 SPECT Yttrium-90 SPECT / CT Yttrium-90 PET/CT Yttrium-90 PET/MRI 61

  • Staff asked .I NL to perform a case study on Yttrium-90 microsphere events over the past 10 years
  • Since Yttrium-90 treatments began (15 years ago), the numbers of medical events have increased
  • The increase in reported medical events is commensurate vvith the increase in use of Yttrium-90 microspheres 62

The Staff Did Not Identify a Negative Performance Trend

  • Based on the INL re.p ort and analysis of the trending data, the staff did not find a negative performance trend or gaps in NRC regulations
  • Though no negative trends were identified at this time, it is beneficial to question our regulations to determine what is adequate when it comes to evolving medical technologies 63

Questions 64

, 'l List of Acronyms

  • ACMUI -Advisory Committee on Medical Uses of Isotopes
  • CER - Cumulative Effects of Regulation
  • CFR - Code of Federal Regulations
  • CRCPD - Conference of Radiation Control Program Directors
  • FAIMIS - Financial Accounting and Integrated Management Information System
  • FCIX - Fuel Cycle Information Exchange
  • FCSE - Division of Fuel Cycle Safety, Safeguards and Environmental Review
  • FDA - Food and Drug Administration
  • FTE - Full Time Equivalent 65

List of Acronyms

  • GAO - Government Accountability Office
  • IMC - Inspection Manual Chapter
  • MDMS- Master Data Management System
  • NMSS - Office of Nuclear Materi*a l Safety and Safeguards
  • NMU - Nuclear Materials Users
  • NMWS - Nuclear Materials and Waste Safety
  • NORM - Naturally Occurring Radioactive Material 66

List of Acronyms

  • NRC - Nuclear Regulatory Commission
  • OAS - Organization of Agreement States
  • OCFO - Office of the Chief Financial Officer
  • OIG - Office of Inspector General
  • SLO - State Liaison Officer
  • RIC - Regulatory ln*f ormation Conference
  • OCFO - Office of the Chief Financial Officer
  • WBL - Web-Based Licensing 67