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{{#Wiki_filter:Brian Gutherman          The Role of for the Nuclear Energy Institute NEI 12-04 In Improving the NRC REG CON December 12, 2018        Focus on Safety
 
NEI 12-04 Endorsement Status
* NEI 12-04, Revision 2 submitted to NRC in September 2018
* Deletes appendices and modifies the document to remove references to those appendices
* Corrects a section numbering error
* Endorsement is expected via a revision to Regulatory Guide 3.72
* Draft RG summer 2019
* Licensees and CoC holders awaiting formal endorsement to incorporate the revised guidance into 72.48 training programs
 
Part of Broader Regulatory Improvements
* The value of 72.48 guidance is limited to the information not requiring NRC approval to change
* Graded approach project seeks to increase the 72.48 change scope based on safety and risk, akin to Part 50 TS improvement program
* Long term value depends on the NRC having confidence that industry 72.48 processes will consistently identify those issues requiring NRC approval
* NRC inspection and enforcement program visibility increases with increased industry responsibility
 
Accomplishments of NEI 12-04
* Distinguishes between specific licensees, general licensees, and CoC holders, where appropriate
* Identifies the 72.212 Report as a licensing basis document requiring review for proposed activities (RIS 2012-05)
* Addresses unique needs of CoC holders having 72.48 authority and no history of 50.59 authority
* Addresses general licensee - CoC holder interface
* GL processing of CoC holder changes
* Cask FSAR revision(s) of record for GLs
* Brings 72.48 guidance into alignment with 50.59 for changes involving Methods of Evaluation (MOE)
* Solidifies the basis for licensee and CoC holder training programs
 
Lessons Learned
* Enforcement actions of 2000s resulted in lingering confusion for both industry and NRC
* 50.59 guidance did not translate to 72.48 as directly as imagined for general licensees and CoC holders
* Industrys request for NRC endorsement could have been defined better
* Some enforcement actions were based on different industry and NRC understanding of the rule and guidance rather than mistakes
 
What is Expected of Industry?
* Understand that the need, appropriateness, and technical quality of changes is assured before the 72.48 review
* Implement a rigorous 72.48 training/qualification program
* Ensure 72.48 documentation matches the elements of the 72.48 guidance, especially MOE changes
* Frequently and critically review your 72.48 training and implementation programs (solicit outside feedback)
* Embrace conservative decision-making and questioning attitude
* Licensees should critically review CoC holder work
 
What is Expected of the NRC?
* Consistency among Regions and individual inspectors
* Risk-informed decision-making
* More 72.48 knowledge in the Regions to improve inspection process efficiency
* Hold industry accountable for the integrity of the process
 
What Does Success Look Like?
* Industry better understands the 72.48 rule and guidance evidenced by fewer mistakes
* NRC increases confidence in 72.48 implementation and allows more information to be under licensee/CoC holder change control
* Fewer 72.48 enforcement actions
 
The Bottom Line
: 1. 10 CFR 72.48 intends for the NRC to review changes having a nexus to the original safety basis with a focus on public health and safety
: 2. Updating the 72.48 implementation guidance was necessary but not sufficient for long-lasting regulatory process improvement
: 3. Right-sizing information in licenses and CoCs will put change control authority where it belongs and better focus resources on safety
 
Questions?
mar@nei.org gutherman@comcast.net}}

Latest revision as of 09:19, 20 October 2019

Presentation Slides: Gutherman - Regulatory Improvements - 72.48
ML18346A517
Person / Time
Site: Nuclear Energy Institute
Issue date: 12/12/2018
From: Gutherman B
Nuclear Energy Institute
To: Haile Lindsay
NRC/NMSS/DSFM/IOB
Lindsay H
Shared Package
ML18338A059 List:
References
Download: ML18346A517 (10)


Text

Brian Gutherman The Role of for the Nuclear Energy Institute NEI 12-04 In Improving the NRC REG CON December 12, 2018 Focus on Safety

NEI 12-04 Endorsement Status

  • NEI 12-04, Revision 2 submitted to NRC in September 2018
  • Deletes appendices and modifies the document to remove references to those appendices
  • Corrects a section numbering error
  • Draft RG summer 2019
  • Licensees and CoC holders awaiting formal endorsement to incorporate the revised guidance into 72.48 training programs

Part of Broader Regulatory Improvements

  • The value of 72.48 guidance is limited to the information not requiring NRC approval to change
  • Graded approach project seeks to increase the 72.48 change scope based on safety and risk, akin to Part 50 TS improvement program
  • Long term value depends on the NRC having confidence that industry 72.48 processes will consistently identify those issues requiring NRC approval
  • NRC inspection and enforcement program visibility increases with increased industry responsibility

Accomplishments of NEI 12-04

  • Distinguishes between specific licensees, general licensees, and CoC holders, where appropriate
  • Identifies the 72.212 Report as a licensing basis document requiring review for proposed activities (RIS 2012-05)
  • Addresses unique needs of CoC holders having 72.48 authority and no history of 50.59 authority
  • Addresses general licensee - CoC holder interface
  • GL processing of CoC holder changes
  • Cask FSAR revision(s) of record for GLs
  • Brings 72.48 guidance into alignment with 50.59 for changes involving Methods of Evaluation (MOE)
  • Solidifies the basis for licensee and CoC holder training programs

Lessons Learned

  • Enforcement actions of 2000s resulted in lingering confusion for both industry and NRC
  • 50.59 guidance did not translate to 72.48 as directly as imagined for general licensees and CoC holders
  • Industrys request for NRC endorsement could have been defined better
  • Some enforcement actions were based on different industry and NRC understanding of the rule and guidance rather than mistakes

What is Expected of Industry?

  • Understand that the need, appropriateness, and technical quality of changes is assured before the 72.48 review
  • Implement a rigorous 72.48 training/qualification program
  • Ensure 72.48 documentation matches the elements of the 72.48 guidance, especially MOE changes
  • Frequently and critically review your 72.48 training and implementation programs (solicit outside feedback)
  • Embrace conservative decision-making and questioning attitude
  • Licensees should critically review CoC holder work

What is Expected of the NRC?

  • Consistency among Regions and individual inspectors
  • Risk-informed decision-making
  • More 72.48 knowledge in the Regions to improve inspection process efficiency
  • Hold industry accountable for the integrity of the process

What Does Success Look Like?

  • Industry better understands the 72.48 rule and guidance evidenced by fewer mistakes
  • NRC increases confidence in 72.48 implementation and allows more information to be under licensee/CoC holder change control
  • Fewer 72.48 enforcement actions

The Bottom Line

1. 10 CFR 72.48 intends for the NRC to review changes having a nexus to the original safety basis with a focus on public health and safety
2. Updating the 72.48 implementation guidance was necessary but not sufficient for long-lasting regulatory process improvement
3. Right-sizing information in licenses and CoCs will put change control authority where it belongs and better focus resources on safety

Questions?

mar@nei.org gutherman@comcast.net