ML18191B033
| ML18191B033 | |
| Person / Time | |
|---|---|
| Issue date: | 07/10/2018 |
| From: | Les Cupidon Office of Nuclear Regulatory Research |
| To: | |
| Cupidon L | |
| References | |
| Download: ML18191B033 (30) | |
Text
LICENSING BASIS AND BACKFITTING WORKSHOP MODULE 3: POTENTIAL SOURCES OF BACKFITTING
WHAT ARE THIS MODULES OBJECTIVES?
Quick refresher on key points from Modules 1 and 2 (HQ Reactor Session B only)
How to recognize potential backfitting issues Where you might encounter backfitting issues LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 2
BACKFITTING REFRESHER HQ REACTOR SESSION B LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 3
DEFINITION OF BACKFITTING The modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility; Any of which may result from a new or amended provision in the Commissions regulations or the imposition of a regulatory staff position interpreting the Commissions regulations that is either new or different from a previously applicable staff position LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 4
BACKFITTING VS. ISSUE FINALITY Similar concepts Preserve stability of regulatory decision Focus change in requirements on safety/security significant issues Different applicability Combined license (COL) applications can incorporate by reference prior approvals (e.g.,
design certification (DC), early site permit (ESP))
COL applications do not need to re-justify matters resolved in these prior approvals LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 5
ISSUE FINALITY Each 10 CFR Part 52 licensing process has different finality requirements ESP - covers updates and variances DC - restricts conditions for amending a DC rule; addresses standardization and material errors COL - refers to 10 CFR 50.109; defines change processes when referencing other approvals Standard Design Approval (SDA) - requires staff reliance on approval when referenced in an application absent new info Manufacturing License (ML) - refers to 10 CFR 50.109; restricts changes to the design Each finality requirement also places restrictions on information requests LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 6
IMPOSITION OF NEW REQUIREMENTS The imposition of new requirements is the focus of backfitting.
The NRC has explicit processes for adding or revising requirements.
Requirements are located in:
Atomic Energy Act of 1954, as amended, and Energy Reorganization Act of 1974, as amended 10 CFR, including standards/guidance incorporated by reference into 10 CFR as a requirement Example: Section III of the American Society of Mechanical Engineers Boiler and Pressure Vessel Code (10 CFR 50.55a(b))
Facility-specific permits/licenses (including technical specifications) and Orders LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 7
NOT REQUIREMENTS Final Safety Analysis Report, as updated Inspections, tests, analyses, and acceptance criteria (ITAAC) for COL holders are not requirements after the 10 CFR 52.103(g) finding (authorization to load fuel), either for licensees or for renewal of the license Commitments made in docketed licensing correspondence and remaining in effect, such as:
Licensee responses to generic communications and enforcement actions Licensee commitments documented in safety evaluations or licensee event reports LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 8
RECOGNITION OF BACKFITTING ISSUES LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 9
KEY POINTS TO CONSIDER What is the licensing basis and design basis? (Module 1)
What entities and what activities are covered by backfitting provisions? (Module 2)
Are you in a situation where you should be thinking about backfitting? (this module)
LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 10
EXTERNAL STAKEHOLDER INTERACTIONS LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 11 NRC staff interacts with external stakeholders in various ways to communicate policy, positions, or decisions Opportunities include:
Public meetings Federal Register notices Routine inspection interactions Generic communications Assessing allegations or petitions
EXTERNAL STAKEHOLDER INTERACTIONS Be mindful that:
Policy is made/changed by the Commission Excluding meetings by the Commission, final regulatory decisions are not made in public meetings Documenting why something is not backfitting can be beneficial Presumption is that previously approved licensing/design basis is safe unless it is determined not to be.
New NRC staff review, operating event, inspection, etc.
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CONSIDERATION OF POLICY AND GUIDANCE NRC guidance (or NRC-approved industry guidance) is usually not the only way of demonstrating that NRC requirements are met - the guidance itself is usually not a requirement Guidance revisions may constitute new or changed staff positions New revision does not apply to licensee unless:
Applied to licensee during issuance of initial license, license amendment, or Order Applicant/licensee requests to use Updated guidance does not necessarily mean previous approach is unsafe/unacceptable.
There are some cases in which guidance can be required A common example is RG 1.33 if it is incorporated into facility-specific technical specifications Non-compliance with the applicable RG 1.33 revision is enforceable (you need to have a direct link)
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WHERE BACKFITTING ISSUES CAN ARISE Communications that do not require the modification of, or addition to, an SSC or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility, normally are not considered backfitting.
Generic communications Enforcement actions Resolution of Task Interface Agreements (TIAs)
However, determining that a regulation is not met based on guidance or requirements not applicable to the approved licensing/design basis could be backfitting.
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POWER REACTOR EXAMPLE - MAINTENANCE RULE Maintenance Rule is documented in 10 CFR 50.65 Industry guidance document: NUMARC 93-01 NRC endorsed NUMARC 93-01 in Regulatory Guide 1.160 What are the requirements and guidance?
What is enforceable?
What could result in backfitting?
LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 15
POWER REACTOR EXAMPLE - MAINTENANCE RULE What are the requirements and guidance?
The regulation (10 CFR 50.65) is a requirement Industry guidance (NUMARC 93-01) and the endorsing Regulatory Guide 1.160 are an acceptable method of meeting the regulation and constitute guidance, not requirements What can you enforce?
Specific requirements of 10 CFR 50.65 What could result in backfitting?
Enforcing non-compliance with NUMARC 93-01 and Regulatory Guide 1.160 unless specifically required LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 16
POTENTIAL SOURCES OF BACKFITTING LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 17
WHERE BACKFITTING ISSUES CAN ARISE Generic communications Inspections and enforcement Resolution of TIAs LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 18
GENERIC COMMUNICATIONS Generic communications must not impose new requirements and must not change the existing interpretation or implementation of existing requirements Would violate Management Directive 8.18 Would constitute backfitting Some generic communications can require a response (Bulletin and Generic Letter) but there is no requirement on what this response must contain; cannot require that actions be taken Must be careful because generic communications are often written with the purpose of discussing regulatory issues and requirements Ensure any requirement or implied requirement can be backed up by actual existing regulations and is discussed in the proper context LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 19
INSPECTION AND ENFORCEMENT The overwhelming majority of inspection activities and enforcement actions is properly carried out and does not result in concerns about unintended backfitting Backfitting is one tool in our regulatory toolbox.
When warranted, engage the backfitting community of practice and use the backfitting process Problem with meeting existing requirement enforcement Problem with approved licensing basis / requirements potential backfitting LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 20
INSPECTION AND ENFORCEMENT Licensees are inspected based on the plant-specific approved licensing basis - presumed to provide adequate protection Non-compliance with approved licensing basis is enforcement - no backfitting concerns Confirm the underlying requirement can be shown to be specifically applicable to the facility in question Recognize whether a particular method of compliance is specifically required, or if licensee has flexibility in how to meet the requirement or standard Other, newer requirements may exist and may be used at other facilities To apply a newer requirement, or to address a safety issue raised with the approved licensing/design basis, backfitting may be needed When issuing findings without violations, ensure the standard is actually self-imposed by the licensee LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 21
INSPECTION AND ENFORCEMENT The inspection program is a sampling program; it is not backfitting if one inspection fails to identify an issue that a later inspection does identify Example:
Plant license issued in 1987 included a tank level requirement of 86%
In 2017, inspectors review tank level calculation, unchanged since initial licensing, and find that an error in the calculation means the required level is actually 88%
Could we take enforcement action or must we use the backfitting process?
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INSPECTION AND ENFORCEMENT The identification of a violation should not in and of itself be a backfit, therefore the inspector can write a violation, even if prior inspections had reviewed the system or calculation and did not identify the problem This is assuming the agency did not specifically review the calculation check Safety Evaluation Reports or Requests for Additional Information extremely unlikely in initial licensing and still unlikely, though possible, in subsequent license amendments If NRC did specifically review and approve the calculation, and thus had an opportunity to find the error, compliance backfitting would likely be the approach to use Note that the licensee would likely voluntarily correct the error LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 23
INSPECTION AND ENFORCEMENT Unintended backfitting can occur if a clear and direct tie to a requirement cannot be demonstrated Specific CFR section or Code edition/section must apply to the specific licensee and activity or equipment in question Stop and seek assistance if there is not a clear, documented link from a specific requirement to the issue of concern Do not imply or state a requirement beyond what is specifically required.
Many requirements are performance-based.
Licensees have flexibility in how they meet the requirement.
NRC should not imply or force licensees to change their practice if they are meeting the requirements.
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POWER REACTOR EXAMPLE - CORRECTIVE ACTIONS Licensee failed to take any corrective actions for a condition adverse to quality 10 CFR Part 50, Appendix B, Criterion XVI requires:
Measures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected. In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.
When considering enforcement, what should you consider to avoid possible unintended backfitting?
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INSPECTION AND ENFORCEMENT - QUALITY EXAMPLE The condition adverse to quality must be shown to be under the purview of Appendix B Appendix B does not require any specific action, just a corrective action - licensee has flexibility to determine what the corrective action can be.
Staff implying or stating that a certain action should be taken may involve backfitting.
Do not provide an opinion if the licensee asks whether a certain action would correct the issue or satisfy the NRC.
Acceptable to point to examples of previous approvals, if requested, without suggesting a particular approach.
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TASK INTERFACE AGREEMENTS TIAs may involve regulatory or policy interpretations Similar to inspection, TIA reviews must carefully consider what is within the facility-specific licensing/design basis Prior NRC staff positions on the subject must be reviewed To avoid unintended backfitting, the response must be consistent with existing staff positions on the specific topic Backfitting may be warranted to address the issue - if so, transition to the backfitting process LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 27
CHANGES TO POSITIONS Changed positions are finalized through review by :
Technical organization Project organization Office of the General Counsel Some decisions may require:
Public interactions Review by Advisory Committee on Reactor Safeguards/Advisory Committee on the Medical Uses of Isotopes Commission approval Congressional review (under the Congressional Review Act - see YA-17-0103 )
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EXPECTATIONS In our interactions regarding approvals or compliance, the NRC staff is expected to:
Understand the current approved licensing/basis of the facility; Understand the scope and applicability of any new or updated regulatory guidance; Comprehensively communicate the safety/risk significance of identified issues; Use the backfitting/issue finality process when appropriate; and, When developing/communicating compliance or technical positions, ensure that those positions appropriately reflect the current approved licensing/basis of the applicable facility.
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QUESTIONS LICENSING BASIS AND BACKFITTING WORKSHOP - SUMMER 2018 - MODULE 3 (POTENTIAL SOURCES) 30