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{{#Wiki_filter:Review of'Operational Programs in a, Combined License Application | {{#Wiki_filter:Review of'Operational Programs in a, Combined License Application | ||
-,z NRh REG CoV June 8, 2005 1: 'Agenda* Goals and Objectives for Combined License Operational Program Review,* Background | -,z NRh REG CoV June 8, 2005 1: | ||
* Proposed Approach for- Combined License Operational Program Review* Key Challenges for Review of Operational Programs* Challenges with Operational Program Implementation | 'Agenda | ||
* Changes to Safety Analysis Report after COL is Issued* Some Suggested NRC Processes Which may Mitigate Challenges | * Goals and Objectives for Combined License Operational Program Review, | ||
* Range of ImplementationdOptions to Address Concerns* Option 2: Informative License Condition* Illustrative Example: Radiation Protection 2 | * Background | ||
* Proposed Approach for- Combined License Operational Program Review | |||
* Key Challenges for Review of Operational Programs | |||
* Challenges with Operational Program Implementation | |||
* Changes to Safety Analysis Report after COL is Issued | |||
* Some Suggested NRC Processes Which may Mitigate Challenges | |||
* Range of ImplementationdOptions to Address Concerns | |||
* Option 2: Informative License Condition | |||
* Illustrative Example: Radiation Protection 2 | |||
=== | __ I aML. | ||
Goals and Objectives for | |||
?Combined License Operational Program Review | |||
*Include acceptable implementation of operational programs as part of the combined license | |||
* Ensure that key elements of operational programs are included in the safety analysis report to allow the NRC to make a reasonable assurance finding on the operational program when the combined license is issued | |||
* For programs which do not have inspections, tests, analyses, and acceptance criteria, ensure that these programs and their implementation are fully described in the safety analysis report | |||
* Ensure that operational programs can be inspected by the NRC prior to implementation 3 | |||
===Background=== | |||
0**I Operational Programs Included in SECY-02-0067 | 0**I Operational Programs Included in SECY-02-0067 | ||
> Originally identified in NEI letter dated May 14, 2001 U | > Originally identified in NEI letter dated May 14, 2001 U Emergency planning | ||
* Physical Security U Quality Assurance | |||
* Fire Protection U Radiation Protection | |||
* Access Authorization U Fitness for Duty . | |||
* SRM-SECY-02-0067 endorsed inspections, tests, analyses, and acceptance criteria (ITAAC) for emergency planning 4 Background (continued) | * Training U Licensed Operator | ||
* Reportability U Containrment Leak Rate Testing | |||
* Maintenance Rule U Inservice Inspection and Inservice | |||
* Equipment Qualification Testing | |||
* SRM-SECY-02-0067 endorsed inspections, tests, analyses, and acceptance criteria (ITAAC) for emergency planning 4 | |||
Background (continued) | |||
* SRM-SECY-02-0067 stated the following: | * SRM-SECY-02-0067 stated the following: | ||
Although the NRC inspe'ction process does not replace a particular ITAAC, an ITAAC should not be necessa'ry if the program and its implementation are fully'described in'the application and found to be' acceptable by the NRC - | Although the NRC inspe'ction process does not replace a particular ITAAC, an ITAAC should not be necessa'ry if the program and its implementation are fully'described in'the application and found to be' acceptable by the NRC -atthe COL [combined license] stage. The burden is'on the applicant to provide the necessary and sufficient programmatic information for approval of the COL without ITAAC 5 -, | ||
Background (continued) | |||
SRM-SECY-04-0032 provided additional clarification: | SRM-SECY-04-0032 provided additional clarification: | ||
'fully described' should be understood to mean that the program is clearly and sufficiently described in terms of the scopeiand level of detail to allow a reasonable assurance finding of acceptability. | 'fully described' should be understood to mean that the program is clearly and sufficiently described in terms of the scopeiand level of detail to allow a reasonable assurance finding of acceptability. | ||
Required programs should always be described at a functional level'and at an increased level of detail where implementation choices could materially and negatively affect the program effectiveness and acceptability. | Required programs should always be described at a functional level' and at an increased level of detail where implementation choices could materially and negatively affect the program effectiveness and acceptability. - | ||
6 | |||
---IJIL-+ Rto 4. Proposed Approach for Combined License Operational Program Review* COL application would contain the following related to operational programs: Safety Analysis Report (SAR) level information | |||
> Additional information for operational programs'where implementation choices could materially and negatively affect the program effectiveness and acceptability | - - -IJIL- | ||
* Discussion of the applicant's implementation plans, including schedule* NRC final safety evaluation report to include staff evaluation of operational programs* COL to include, where necessary, license conditions on implementation of operational programs, as described in the SAR (i.e., for programs that will not be implemented at the time the COL is issued)7^RtO>~ Proposed Approach for' Combined License Operational , Program Review (continued) | + Rto 4. Proposed Approach for Combined License Operational Program Review | ||
* Approach consistent with current process of including license conditions in renewed operating licenses* Approach assumes that operational programs do not need ITAAC unless'the' staff determines that an implementation issue is inseparable from the finding on program acceptability, and an ITAAC is necessary* COL applicants may propose ITAAC for implementation of any operational program* Program must be fully described in SAR in order for NRC to make a reasonable assurance finding 8 Key Challenges for Review of Operational Programs Make a reasonable assurance finding on an operational program before a plant is constructed and operated> SAR needs to include level of detail sufficient to make a reasonable assurance finding ..* No inspection, tests, analyses, acceptance criteria (ITAAC) needed if program and its implementation can be fully described Ensure that the key elements of the operational program used by NRC to make reasonable assurance finding are included in the implementation of the operational program* Assurance provided by inspection of operational program prior to implementation 9*QOR REQb@4 z u Challenges with Operational Program Implementation | * COL application would contain the following related to operational programs: | ||
* Time period between COL issuance and program implementation | Safety Analysis Report (SAR) level information | ||
> Could be several years after license is issued 10 ' | > Additional information for operational programs'where implementation choices could materially and negatively affect the program effectiveness and acceptability | ||
----LJIL-0t Changes to SAR after COL is Issued* Allowed by 10. CFR 50.54 or 50.59* Periodic reporting requirements to NRC* Current regulations do not account for fact that will have final SAR years before a plant is built and operated 11 Some Suggested NRC Controls D Which May Mitigate Challenges | * Discussion of the applicant's implementation plans, including schedule | ||
* Controls on changes to operational program descriptions in SARs after COL is issued* Timely exchange of information on changes to SARs that impact operational programs* Ability to perform inspections of operational programs prior to implementation | * NRC final safety evaluation report to include staff evaluation of operational programs | ||
* Process to resolve findings from these operational program inspections 12 Range of Implementation | * COL to include, where necessary, license conditions on implementation of operational programs, as described in the SAR (i.e., for programs that will not be implemented at the time the COL is issued) 7 | ||
/ Options to Address Concerns Option 1: Restrictive License Condition Changes in SAR on operational program information will require NRC approval until operational program fully implemented | ^RtO>~ Proposed Approach for | ||
('Tier 2* for Operational Programs") | ' Combined License Operational | ||
, Program Review (continued) | |||
* Approach consistent with current process of including license conditions in renewed operating licenses | |||
* Approach assumes that operational programs do not need ITAAC unless'the' staff determines that an implementation issue is inseparable from the finding on program acceptability, and an ITAAC is necessary | |||
* COL applicants may propose ITAAC for implementation of any operational program | |||
* Program must be fully described in SAR in order for NRC to make a reasonable assurance finding 8 | |||
Key Challenges for Review of Operational Programs Make a reasonable assurance finding on an operational program before a plant is constructed and operated | |||
> SAR needs to include level of detail sufficient to make a reasonable assurance finding. . | |||
* No inspection, tests, analyses, acceptance criteria (ITAAC) needed if program and its implementation can be fully described Ensure that the key elements of the operational program used by NRC to make reasonable assurance finding are included in the implementation of the operational program | |||
* Assurance provided by inspection of operational program prior to implementation 9 | |||
*QOR REQb@4 z u Challenges with Operational Program Implementation | |||
*Time period between COL issuance and program implementation | |||
> Could be several years after license is issued 10 ' | |||
---- LJIL-0t Changes to SAR after COL is Issued | |||
* Allowed by 10. CFR 50.54 or 50.59 | |||
* Periodic reporting requirements to NRC | |||
* Current regulations do not account for fact that will have final SAR years before a plant is built and operated 11 Some Suggested NRC Controls D Which May Mitigate Challenges | |||
* Controls on changes to operational program descriptions in SARs after COL is issued | |||
* Timely exchange of information on changes to SARs that impact operational programs | |||
* Ability to perform inspections of operational programs prior to implementation | |||
* Process to resolve findings from these operational program inspections 12 | |||
Range of Implementation | |||
/ Options to Address Concerns Option 1: Restrictive License Condition Changes in SAR on operational program information will require NRC approval until operational program fully implemented ('Tier 2*for Operational Programs") | |||
Requires NRC notification prior to operational program implementation | Requires NRC notification prior to operational program implementation | ||
* Verification of acceptable | * Verification of acceptable .- I ' a Restrictive operational program implementation in license , Increased burden on NRC to | ||
.-operational program implementation in license* Ensures that key elements of operational program remain in SAR until program implemented | .'review any changes | ||
* Ensures that key elements of operational program remain in SAR until program implemented | |||
* Program and its implementation remain fully described | |||
* NRC informed of operational program implementation in preparation for inspection 13 Range of Implementation Options to Address Concerns (continued) | |||
* Option 2: Informative License Condition Requires NRC notification prior~to operational program implementation | * Option 2: Informative License Condition Requires NRC notification prior~to operational program implementation | ||
' Licensee submits most recent SAR changes related to operational programs since'last report to NRC ''* Verification of acceptable operational program implementation in license* Allows NRC to review changes in timely manner to ensure that key elements of operational program supporting reasonable assurance finding have not been removed from SAR before implementation,--,.- | ' Licensee submits most recent SAR changes related to operational programs since'last report to NRC '' | ||
* Verification of acceptable operational | |||
* No restrictions on program implementation in license I changes .. | |||
* Allows NRC to review changes in timely | |||
* NRC only reviews manner to ensure that key elements of changes prior to operational program supporting reasonable implementation of assurance finding have not been removed -operational program from SAR before implementation,--,.- | |||
* Allows NRC to review changes to ensure program and its implementation remain fully described before implementation | * Allows NRC to review changes to ensure program and its implementation remain fully described before implementation | ||
* NRC informed of operational program implementation in preparation for inspection | * NRC informed of operational program implementation in preparation for inspection | ||
' Options to Address Concerns (continued) | I WI fi RE014 Range of Implementation | ||
* Option 3: No License Condition> Implementation of operational programs only discussed in SAR* No requirements for licensee to submit information or inform NRC of operational program implementation | ' Options to Address Concerns (continued) | ||
* Verification of acceptable operational program implementation not in license* No regulatory means to ensure that key elements supporting reasonable assurance finding remain in SAR when program implemented | * Option 3: No License Condition | ||
> Implementation of operational programs only discussed in SAR | |||
* No requirements for licensee to submit information or inform NRC of operational program implementation | |||
* Verification of acceptable operational | |||
* No restrictions on changes program implementation not in license | |||
* NRC only reviews changes | |||
* No regulatory means to ensure that after required periodic key elements supporting reasonable updates submitted assurance finding remain in SAR when program implemented | |||
* Program and its implementation may no longer be fully described when implemented | * Program and its implementation may no longer be fully described when implemented | ||
* No assurance that inspection may be performed before program is implemented | * No assurance that inspection may be performed before program is implemented 15 Option 2: | ||
5 Informative License Condition (continued) | |||
License Condition Implementation: | License Condition Implementation: | ||
* Notify NRC when program is about to be implemented | * Notify NRC when program is about to be implemented | ||
* Provide NRC with changes to SAR since last update required by 10 CFR 50.71 (e) that impact the operational program being implemented | * Provide NRC with changes to SAR since last update required by 10 CFR 50.71 (e)that impact the operational program being implemented | ||
* Condition ends on specific operational program when either Commission provides authorization to load fuel or program required to be fully implemented Purpose:* Ensure that program is implemented as described in SAR* Ensure that SAR fully describes operational program and its implementation | * Condition ends on specific operational program when either Commission provides authorization to load fuel or program required to be fully implemented | ||
* Ensure that key elements used to reach reasonable assurance finding on operational program at COL remain in place* Allow sufficient time to schedule and prepare for NRC inspection of operational program prior to implementation 16 | |||
&,E4' Option 2: , Informative License Condition (continued) | ==Purpose:== | ||
* Ensure that program is implemented as described in SAR | |||
* Ensure that SAR fully describes operational program and its implementation | |||
* Ensure that key elements used to reach reasonable assurance finding on operational program at COL remain in place | |||
* Allow sufficient time to schedule and prepare for NRC inspection of operational program prior to implementation 16 | |||
&,E4' Option 2: | |||
, Informative License Condition (continued) | |||
Attributes: | Attributes: | ||
* Licensee informs NRC that a operational program will be implemented in X months* Licensee provides any additional changes to SAR implemented after last change report required by | * Licensee informs NRC that a operational program will be implemented in X months | ||
* For programs with phased implementation, licensee reports on implementation milestone and relevant 10 CFR 50.71 (e) reports X months before that phase of operational program is implemented 17 o / Illustrative Example NEt 04-01, Section 4.3.9.12: FSAR Chapter 12, Radiation Protection | * Licensee provides any additional changes to SAR implemented after last change report required by 10 CFR 50.71 (e), which are related to the operational program, X months before implementation | ||
* For programs with phased implementation, licensee reports on implementation milestone and relevant 10 CFR 50.71 (e) reports X months before that phase of operational program is implemented 17 o / Illustrative Example NEt 04-01, Section 4.3.9.12: | |||
FSAR Chapter 12, Radiation Protection | |||
* Example Health Physics Program Description | * Example Health Physics Program Description | ||
> Example taken from current operating plant FSAR Inadequate information to review radiation protection operational program in COL application | > Example taken from current operating plant FSAR Inadequate information to review radiation protection operational program in COL application | ||
* Parallel effort currently underway to work with NEI to modify this section in NEI 04-01* Need to ensure that all operational programs described in SAR receive this level of consideration by COL applicants 18}} | * Parallel effort currently underway to work with NEI to modify this section in NEI 04-01 | ||
* Need to ensure that all operational programs described in SAR receive this level of consideration by COL applicants 18}} |
Latest revision as of 07:46, 9 December 2019
ML051640425 | |
Person / Time | |
---|---|
Site: | Nuclear Energy Institute |
Issue date: | 06/08/2005 |
From: | NRC/NRR/DRIP/RNRP |
To: | Nuclear Energy Institute |
Colaccino,Joseph,NRR/DRIP/RNRP,415-2753 | |
Shared Package | |
ML051730107 | List: |
References | |
Download: ML051640425 (9) | |
Text
Review of'Operational Programs in a, Combined License Application
-,z NRh REG CoV June 8, 2005 1:
'Agenda
- Goals and Objectives for Combined License Operational Program Review,
- Background
- Proposed Approach for- Combined License Operational Program Review
- Key Challenges for Review of Operational Programs
- Challenges with Operational Program Implementation
- Changes to Safety Analysis Report after COL is Issued
- Some Suggested NRC Processes Which may Mitigate Challenges
- Range of ImplementationdOptions to Address Concerns
- Option 2: Informative License Condition
- Illustrative Example: Radiation Protection 2
__ I aML.
Goals and Objectives for
?Combined License Operational Program Review
- Include acceptable implementation of operational programs as part of the combined license
- Ensure that key elements of operational programs are included in the safety analysis report to allow the NRC to make a reasonable assurance finding on the operational program when the combined license is issued
- For programs which do not have inspections, tests, analyses, and acceptance criteria, ensure that these programs and their implementation are fully described in the safety analysis report
- Ensure that operational programs can be inspected by the NRC prior to implementation 3
Background
0**I Operational Programs Included in SECY-02-0067
> Originally identified in NEI letter dated May 14, 2001 U Emergency planning
- Physical Security U Quality Assurance
- Fire Protection U Radiation Protection
- Access Authorization U Fitness for Duty .
- Training U Licensed Operator
- Reportability U Containrment Leak Rate Testing
- Maintenance Rule U Inservice Inspection and Inservice
- Equipment Qualification Testing
- SRM-SECY-02-0067 endorsed inspections, tests, analyses, and acceptance criteria (ITAAC) for emergency planning 4
Background (continued)
- SRM-SECY-02-0067 stated the following:
Although the NRC inspe'ction process does not replace a particular ITAAC, an ITAAC should not be necessa'ry if the program and its implementation are fully'described in'the application and found to be' acceptable by the NRC -atthe COL [combined license] stage. The burden is'on the applicant to provide the necessary and sufficient programmatic information for approval of the COL without ITAAC 5 -,
Background (continued)
SRM-SECY-04-0032 provided additional clarification:
'fully described' should be understood to mean that the program is clearly and sufficiently described in terms of the scopeiand level of detail to allow a reasonable assurance finding of acceptability.
Required programs should always be described at a functional level' and at an increased level of detail where implementation choices could materially and negatively affect the program effectiveness and acceptability. -
6
- - -IJIL-
+ Rto 4. Proposed Approach for Combined License Operational Program Review
- COL application would contain the following related to operational programs:
Safety Analysis Report (SAR) level information
> Additional information for operational programs'where implementation choices could materially and negatively affect the program effectiveness and acceptability
- Discussion of the applicant's implementation plans, including schedule
- NRC final safety evaluation report to include staff evaluation of operational programs
- COL to include, where necessary, license conditions on implementation of operational programs, as described in the SAR (i.e., for programs that will not be implemented at the time the COL is issued) 7
^RtO>~ Proposed Approach for
' Combined License Operational
, Program Review (continued)
- Approach consistent with current process of including license conditions in renewed operating licenses
- Approach assumes that operational programs do not need ITAAC unless'the' staff determines that an implementation issue is inseparable from the finding on program acceptability, and an ITAAC is necessary
- Program must be fully described in SAR in order for NRC to make a reasonable assurance finding 8
Key Challenges for Review of Operational Programs Make a reasonable assurance finding on an operational program before a plant is constructed and operated
> SAR needs to include level of detail sufficient to make a reasonable assurance finding. .
- No inspection, tests, analyses, acceptance criteria (ITAAC) needed if program and its implementation can be fully described Ensure that the key elements of the operational program used by NRC to make reasonable assurance finding are included in the implementation of the operational program
- Assurance provided by inspection of operational program prior to implementation 9
- QOR REQb@4 z u Challenges with Operational Program Implementation
- Time period between COL issuance and program implementation
> Could be several years after license is issued 10 '
LJIL-0t Changes to SAR after COL is Issued
- Allowed by 10. CFR 50.54 or 50.59
- Periodic reporting requirements to NRC
- Current regulations do not account for fact that will have final SAR years before a plant is built and operated 11 Some Suggested NRC Controls D Which May Mitigate Challenges
- Timely exchange of information on changes to SARs that impact operational programs
- Ability to perform inspections of operational programs prior to implementation
- Process to resolve findings from these operational program inspections 12
Range of Implementation
/ Options to Address Concerns Option 1: Restrictive License Condition Changes in SAR on operational program information will require NRC approval until operational program fully implemented ('Tier 2*for Operational Programs")
Requires NRC notification prior to operational program implementation
- Verification of acceptable .- I ' a Restrictive operational program implementation in license , Increased burden on NRC to
.'review any changes
- Ensures that key elements of operational program remain in SAR until program implemented
- Program and its implementation remain fully described
- NRC informed of operational program implementation in preparation for inspection 13 Range of Implementation Options to Address Concerns (continued)
- Option 2: Informative License Condition Requires NRC notification prior~to operational program implementation
' Licensee submits most recent SAR changes related to operational programs since'last report to NRC
- Verification of acceptable operational
- No restrictions on program implementation in license I changes ..
- Allows NRC to review changes in timely
- NRC only reviews manner to ensure that key elements of changes prior to operational program supporting reasonable implementation of assurance finding have not been removed -operational program from SAR before implementation,--,.-
- Allows NRC to review changes to ensure program and its implementation remain fully described before implementation
- NRC informed of operational program implementation in preparation for inspection
I WI fi RE014 Range of Implementation
' Options to Address Concerns (continued)
- Option 3: No License Condition
> Implementation of operational programs only discussed in SAR
- No requirements for licensee to submit information or inform NRC of operational program implementation
- Verification of acceptable operational
- No restrictions on changes program implementation not in license
- NRC only reviews changes
- No regulatory means to ensure that after required periodic key elements supporting reasonable updates submitted assurance finding remain in SAR when program implemented
- Program and its implementation may no longer be fully described when implemented
- No assurance that inspection may be performed before program is implemented 15 Option 2:
5 Informative License Condition (continued)
License Condition Implementation:
- Notify NRC when program is about to be implemented
- Provide NRC with changes to SAR since last update required by 10 CFR 50.71 (e)that impact the operational program being implemented
- Condition ends on specific operational program when either Commission provides authorization to load fuel or program required to be fully implemented
Purpose:
- Ensure that program is implemented as described in SAR
- Ensure that SAR fully describes operational program and its implementation
- Ensure that key elements used to reach reasonable assurance finding on operational program at COL remain in place
- Allow sufficient time to schedule and prepare for NRC inspection of operational program prior to implementation 16
&,E4' Option 2:
, Informative License Condition (continued)
Attributes:
- Licensee informs NRC that a operational program will be implemented in X months
- Licensee provides any additional changes to SAR implemented after last change report required by 10 CFR 50.71 (e), which are related to the operational program, X months before implementation
- For programs with phased implementation, licensee reports on implementation milestone and relevant 10 CFR 50.71 (e) reports X months before that phase of operational program is implemented 17 o / Illustrative Example NEt 04-01, Section 4.3.9.12:
FSAR Chapter 12, Radiation Protection
- Example Health Physics Program Description
> Example taken from current operating plant FSAR Inadequate information to review radiation protection operational program in COL application
- Parallel effort currently underway to work with NEI to modify this section in NEI 04-01