ML13039A461
ML13039A461 | |
Person / Time | |
---|---|
Site: | Indian Point |
Issue date: | 11/06/2012 |
From: | Faison C Entergy Nuclear Operations |
To: | Atomic Safety and Licensing Board Panel |
SECY RAS | |
References | |
RAS 24008, ASLBP 07-858-03-LR-BD01, 50-247-LR, 50-286-LR | |
Download: ML13039A461 (47) | |
Text
United States Nuclear Regulatory Commission Official Hearing Exhibit Entergy Nuclear Operations, Inc.
In the Matter of:
(Indian Point Nuclear Generating Units 2 and 3)
ASLBP #: 07-858-03-LR-BD01 Docket #: 05000247 l 05000286 Exhibit #: ENT000602-00-BD01 Identified: 1/15/2013 Admitted: 1/15/2013 Withdrawn: ENT000602 Rejected: Stricken:
Submitted: January 11, 2013 Other:
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 1 OF 47 Process Applicability Determination Procedure Contains NMM REFLIB Forms: YES NO Effective Date Procedure Owner: Charlene Faison Governance Owner: John McCann
Title:
Manager Licensing
Title:
VP, Nuclear Safety, Site: White Plains Office Site: EP & Licensing 11/06/12 White Plains Office Exception Site Site Procedure Champion Title Date*
ANO David Bice Senior Licensing Specialist N/A BRP N/A N/A CNS David Vanderkamp Manager, Licensing GGNS Rita Jackson Senior IPEC Spec-Nuc Safety/License IV JAF Mark Hawes Spec-Nuc Safety/License IV PLP Jeff Erickson Sr. Engineer PNPS RBS VY Robert Wanczyk Manager, Licensing W3 Senior HQN T.R. Jones Senior Staff Engineer N/A NP N/A N/A Site and NMM Procedures Canceled or Superseded By This Revision None Process Applicability Exclusion: All Sites:
Specific Sites: ANO BRP GGNS IPEC JAF PLP PNPS RBS VY W3 NP Change Statement Revision 12 makes the following changes
- 1. Added Reference 2.1[5].
- 2. Added Reference 2.2[7].
- 3. Updated Definition for 3.0[16], 3.0[17], 3.0[19].
- 4. Corrected step 5.2.[8](b) - Qualification of personnel is covered in Section 5.6, not Section 5.5.
- 5. Updated Attachment 9.1 and 9.2, Document Review, Licensing Basis Documents descriptions for FPP, FSA/FHA to match updated definitions, and included Fire Protection Impact Reviews.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 2 OF 47 Process Applicability Determination TABLE OF CONTENTS SECTION TITLE PAGE 1.0 Purpose 3 2.0 References 3 2.1 Regulatory References 3 2.2 Industry References 4 3.0 Definitions 4 4.0 Responsibilities 10 5.0 Details 11 5.1 Precautions and Limitations 11 5.2 General Overview 11 5.3 Process Applicability Determination (PAD) 13 5.4 Process Applicability Exclusion 13 5.5 Revisions of PAD Forms 15 5.6 Qualification of Personnel 15 6.0 Interfaces 16 7.0 Records 17 8.0 Site Specific Commitments 17 9.0 Attachments 18 Attachment 9.1 Process Applicability Determination Form 19 Attachment 9.2 PAD Form Instructions 26 Attachment 9.3 PAD Process Flowchart 45
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 3 OF 47 Process Applicability Determination 1.0 PURPOSE
[1] This procedure establishes:
(a) A method for determining which plant licensing basis documents (LBDs) and processes are affected by a proposed activity and must be revised to reflect that activity.
(b) A method for determining the appropriate regulatory review (e.g.,
10 CFR 50.54, 10 CFR 50.59, 10 CFR 72.48) or industry code review that is required for implementing a proposed activity.
(c) A method for determining whether an activity requires review in a 50.59 or a 72.48 Evaluation.
2.0 REFERENCES
2.1 REGULATORY REFERENCES
[1] 10 CFR 20, Standards for Protection Against Radiation
[2] 10 CFR 50.2, Definitions
[3] 10 CFR 50.12, Specific Exemptions
[4] 10 CFR 50.36, Technical Specifications
[5] 10 CFR 50.48, Fire Protection
[6] 10 CFR 50.54, Conditions of Licenses
[7] 10 CFR 50.59, Changes, Tests, and Experiments
[8] 10 CFR 50.55a, Codes and Standards
[9] 10 CFR 50.65, Requirements for Monitoring the Effectiveness of Maintenance at Nuclear Power Plants
[10] 10 CFR 50.71(e), Maintenance of Records, Making of Reports
[11] 10 CFR 50.90, Application for Amendment of License or Construction Permit
[12] 10 CFR 72.7, Specific Exemptions
[13] 10 CFR 72.48, Changes, Tests, and Experiments
[14] NRR Office Instruction LIC-100, Control of Licensing Bases for Operating Reactors
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 4 OF 47 Process Applicability Determination 2.2 INDUSTRY REFERENCES
[1] NEI 96-07, Guidelines for 10 CFR 50.59 Implementation
[2] NEI 96-07, Appendix B, Guidelines for 10 CFR 72.48 Implementation
[3] NEI 96-07, Appendix E, Users Guide for NEI 96-07, Revision 1, Guidelines for 10 CFR 50.59 Implementation
[4] NEI 98-03, Guidelines for Updating Final Safety Analysis Reports
[5] NEI 99-04, Guidelines for Managing NRC Commitment Changes
[6] NEI 01-01, Guideline on Licensing Digital Upgrades
[7] NEI 04-02, Guidance for Implementing a Risk-Informed, Performance-based Fire Protection Program under 10 CFR 50.48 (c) 3.0 DEFINITIONS
[1] 10 CFR 72.212 Evaluation Report (212 Report) - The document that describes how an Independent Spent Fuel Storage Installation (ISFSI) complies with the requirements of 10 CFR 72.212 to conduct spent fuel storage activities.
[2] 50.59 Program Coordinator - The designated individual at each site (including headquarters) who serves as the contact of the Process Applicability Determination program, maintains the program, and conducts/provides needed training.
[3] 50.59/72.48 Screening Review - The portion of the Process Applicability Determination (PAD) process that determines whether a proposed plant change requires performance of a detailed 10 CFR 50.59 Evaluation or 10 CFR 72.48 Evaluation per EN-LI-101 or EN-LI-112, respectively.
[4] Adverse - Changes having a negative impact on a design function, a method of controlling a design function, or a method of evaluation as described in Section 4.2 of NEI 96-07.
[5] Change - Change means a modification or addition to, or removal from, the facility or procedures that affects:
(a) A design function, or (b) A method of performing or controlling the design function, or
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 5 OF 47 Process Applicability Determination (c) A method of evaluation that demonstrates the intended design functions will be accomplished.
An activity involving a system, structure, or component (SSC) not explicitly described in the UFSAR or CFSAR that has the potential to affect the function of an SSC that is explicitly described in the UFSAR or CFSAR is also considered a change.
[6] Cyber Security Plan - The document that describes how the requirements of 10 CFR 73.54, Protection of digital computer and communication systems and networks, are implemented.
[7] Core Operating Limits Report (COLR) - The document that provides the core operating limits for the facilitys current fuel cycle.
[8] Described in the UFSAR/CFSAR - SSCs, procedures, tests, descriptions, analyses, drawings, etc. that are described explicitly or implicitly in the Updated Final Safety Analysis Report (UFSAR) or the Spent Fuel Storage Cask Final Safety Analysis Report (CFSAR).
[9] Design bases - Information that identifies the specific functions to be performed by an SSC of a facility (see 10 CFR 50.2) or of a spent fuel storage cask (see 10 CFR 72.3) and the specific values or range of values chosen for controlling parameters as reference bounds for design. These values may be:
(a) Restraints derived from generally accepted "state-of-the-art" practices for achieving functional goals; or (b) Requirements derived from analysis (based on calculations and/or experiments) of the effects of a postulated accident (for the facility) or event (for the storage cask) for which an SSC must meet its functional goals.
[10] Design function - UFSAR-described or CFSAR-described design bases functions and other SSC functions described in the UFSAR or the CFSAR that support or impact design bases functions. Design bases functions are functions performed by SSCs that are (1) required by, or otherwise necessary to comply with, regulations, license conditions, orders, or technical specifications, or (2) credited in licensee safety analyses to meet NRC requirements. Implicitly included within the meaning of design function are the conditions under which intended functions are required to be performed, such as equipment response times, process conditions, equipment qualification, and single failure criteria. This may include:
(a) Functions performed by safety-related SSCs or non-safety-related SSCs; and
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 6 OF 47 Process Applicability Determination (b) Functions of non-safety-related SSCs that, if not performed, would initiate a plant transient or accident.
[11] Emergency Plan (E-Plan) - The document that describes the licensees plan for coping with emergencies, including the items specified in 10 CFR 50.34, 10 CFR 50.47, and 10 CFR 50 Appendix E.
NOTE ANO, JAF, PNPS, and VY do not have Environmental Protection Plans.
[12] Environmental Protection Plan (EPP) - The document that provides for the protection of environmental values during construction and operation of the nuclear facility.
[13] Evaluation that demonstrates that intended functions will be accomplished - The method(s) used to perform the evaluation. For example, a thermodynamic calculation that demonstrates the emergency core cooling system has sufficient heat removal capacity for responding to a postulated accident.
[14] Facility as described in the UFSAR/CFSAR -
(a) The SSCs that are described in the UFSAR or CFSAR, (b) Design and performance requirements for such SSCs described in the UFSAR or CFSAR, and (c) Evaluations or methods of evaluation included in the UFSAR or CFSAR for such SSCs that demonstrate the intended function(s) will be accomplished.
[10 CFR 50.59(a)(3) and 10 CFR 72.48(a)(3)]
[15] Final Safety Analysis Report (as updated) (UFSAR) - The document submitted to the NRC in accordance with 10 CFR 50.34, as amended and supplemented, and as updated per the requirements of 10 CFR 50.71(e). [10 CFR 50.59(a)(4) and (c)(3)]
[16] Fire Safety Analysis/Fire Hazards Analysis (FSA/FHA) - The document that contains fire safety analysis/fire hazards analysis performed for the facility. This analysis evaluates the fire protection system capabilities of the facility and determines compliance to applicable design or licensing basis requirements. The FSA/FHA is part of the Fire Protection Program (FPP), although it may be maintained as a separate document or set of documents.
[17] Fire Protection Program (FPP) - The document(s) that provide the integration of systems, structures, components, administrative controls, procedures, and personnel necessary to satisfy the requirements of 10 CFR 50.48 Fire Protection.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 7 OF 47 Process Applicability Determination
[18] Incorporated by Reference - A method by which all or part of a separate source document can be made part of the UFSAR without duplicating the desired information in the FSAR. Information appropriate to include in the UFSAR that is also part of a separate licensee-controlled document or technical report may be incorporated into the UFSAR by appropriate reference to that information. By relying on information incorporated by reference, licensees may simplify their UFSARs by removing information that is duplicated in separate, controlling program documents.
[19] Licensing Basis Documents (LBDs) - Documents that contain analyses and evaluations describing the licensing basis aspects of the facility. These typically include the UFSAR, the OL, the TS, the TS Bases, the TRM, the FPP, the FSA/FHA, the EPP, the COLR, the Quality Assurance Program Manual (QAPM),
the E-Plan, the Security Plan, the Offsite Dose Calculation Manual (ODCM),
CFSAR, the CoC, the 72.212 Report, and NRC Orders, depending on the site.
[20] LBD Owner - The group or individual responsible for issuing and/or processing LBD changes.
[21] Method of evaluation - The calculational framework used for evaluating behavior or response of the facility or an SSC.
[22] Method of performing or controlling a design function - How a design function is accomplished as credited in the safety analyses, including specific operator actions, procedural steps or sequences, or whether a specific function is to be initiated by manual versus automatic means. For example, substituting a manual actuation for automatic would constitute a change to the method of performing or controlling the function.
[23] NRC Order - A regulatory requirement issued by the NRC that modifies, suspends, or revokes an OL or takes such other action. NRC Orders are governed in accordance with 10 CFR 2.202 and are usually incorporated into the facilitys OL as a License Condition.
[24] Offsite Dose Calculation Manual (ODCM) - The document that describes the methodology and parameters used to calculate offsite doses resulting from radioactive liquid and gaseous effluents as well as monitoring alarm and trip setpoints, (These setpoints may actually be located in the TRM or the UFSAR).
It also describes the Radiological Environmental Monitoring Program (REMP).
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 8 OF 47 Process Applicability Determination
[25] Operating License (OL) - The document issued by the NRC that authorizes operation of a nuclear facility subject to the terms and conditions identified in the document. The OL may include: Appendix A, Technical Specifications (TS);
Appendix B, Environmental Protection Plan; Appendix C, Anti-Trust Conditions; NRC Orders as applicable; and other License Conditions.
[26] Pressure and Temperature Limits Report (PTLR) - A report that establishes and documents reactor coolant system pressure and temperature limits for heat up, low temperature operation, criticality, and hydrostatic testing, as well as heatup and cooldown rates.
[27] Procedures as Described in the UFSAR - Those procedures that contain information described in the UFSAR such as how SSCs are operated and controlled (including assumed operator actions and response times).
[28] Process Applicability Exclusion - The process for excluding a procedure from future PAD reviews based on the exclusion criteria in Section 5.4. If a procedure is revised such that the document or procedure no longer meets the exclusion criteria in Section 5.4, then a PAD needs to be completed for the procedure revision.
[29] Qualified Individual - A person who is qualified per Section 5.5 to function as a Preparer or Reviewer.
[30] Screen in - The term indicating that a 50.59 or a 72.48 Evaluation is required for the proposed activity.
[31] Screen out - The term that indicates there is clear basis that there is no adverse effect on a UFSAR/CFSAR-described design function and no 50.59 or 72.48 Evaluation is required.
NOTE The Security Plan is classified as safeguards information and can only be viewed by authorized personnel. It is NOT available electronically.
[32] Security Plan - The document(s) that describes the licensees plan for maintaining a safeguards contingency plan, including items specified in 10 CFR 50.34 and 10 CFR Part 73 Appendix C.
[33] Spent Fuel Storage Cask Certificate Holder - A person or company who has been issued a Certificate of Compliance by the NRC for a spent fuel storage cask design. This person/company is usually the cask designer/vendor.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 9 OF 47 Process Applicability Determination
[34] Spent Fuel Storage Cask Certificate of Compliance (CoC) - The certificate issued by the NRC that approves the design of a spent fuel storage cask in accordance with the provisions of 10 CFR Part 72 Subpart L, Approval of Spent Fuel Storage Casks. The CoC is typically comprised of sections containing technical specifications (conditions applicable to the cask, operations, surveillance requirements, maintenance, quality assurance, heavy loads) and cask design features.
[35] Spent Fuel Storage Cask Technical Specifications Bases (CTS Bases) - Located in the CFSAR, the section describing the underlying elements and bases of the CoC requirements. Included is information on cask loading and unloading, specific safety functions, related safety analyses, and surveillance testing.
[36] Spent Fuel Storage Cask Final Safety Analysis Report (CFSAR) - For general licensees, the CFSAR for the particular cask design used at the ISFSI, as updated by the certificate holder in accordance with 10 CFR 72.248 (including changes since the last update), and as supplemented by changes made by the general licensee and certificate holder under 10 CFR 72.48. [10 CFR 72.48(c)(3)]
[37] Technical Requirements Manual (TRM) - The document that contains those limitations upon plant operations which are part of the licensing basis for the facility but do not meet the criteria for inclusion in the TS. It also contains information that supplements the TS.
[38] Technical Specifications (TS) - The portion of the plant OL that contains safety limits, limiting conditions for operation, surveillance requirements, design features, administrative controls, and other requirements imposed on the operation of the plant.
[39] Technical Specification Bases (TS Bases) - The document that describes the underlying elements and bases of each TS. The TS Bases may include information on system operation, specific safety functions, related safety analyses, and surveillance testing.
[40] Test or experiment not described in the UFSAR/CFSAR - Any activity where any SSC is utilized or controlled in a manner that is either:
(a) Outside the reference bounds of the design bases as described in the UFSAR/CFSAR; or (b) Inconsistent with the analyses or descriptions in the UFSAR/CFSAR.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 10 OF 47 Process Applicability Determination Inservice Inspection (ISI) and Inservice Testing (IST) activities controlled in accordance with 10 CFR 50.55a and activities performed in accordance with TS surveillance test procedures are not considered to be tests or experiments not described in the UFSAR/CFSAR.
4.0 RESPONSIBILITIES
[1] The corporate Nuclear Safety & Licensing (NS&L) Department is responsible for maintaining this procedure.
[2] Each site 50.59 Program Coordinator is responsible for:
(a) Overseeing implementation of the PAD program at his/her site.
(b) Ensuring training is provided in support of this procedure.
[3] Each site Manager of Training and Development is responsible for maintaining training records of Qualified Individuals and providing training support, as appropriate.
[4] The Preparer is responsible for:
(a) Performing a PAD and determining any effects on the facilitys LBDs and processes, as identified in Attachment 9.1, (b) Identifying the appropriate regulatory review process used to implement the proposed change, and (c) Ensuring that changes to affected documents are initiated, if applicable.
[5] The Reviewer is responsible for reviewing the PAD and concurring with its conclusions based on the evidence presented (this concurrence is NOT an independent review as defined in ANSI N18.7 Section 2.2).
[6] Each Process Owner is responsible for ensuring process reviews are performed for proposed activities that affect his/her process prior to implementing those activities.
[7] Each Site Procedure Champion is responsible for approving a Process Applicability Exclusion for an NMM document or procedure and ensuring that the conclusions stated by the Preparer are correct. By signing the Process Applicability Exclusion, the Site Procedure Champion acknowledges and agrees with applying the exclusion to the particular document or procedure.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 11 OF 47 Process Applicability Determination
[8] Each Site Procedure Owner is responsible for approving Process Applicability Exclusions for site-specific documents or procedures and ensuring that the conclusions stated by the Preparer are correct. By signing the Process Applicability Exclusion, the Site Procedure Owner acknowledges and agrees with applying the exclusion to the particular document or procedure.
5.0 DETAILS 5.1 PRECAUTIONS AND LIMITATIONS
[1] LBDs and process documents are expected to be accurate. If an error or discrepancy that constitutes an adverse condition as defined in procedure EN-LI-102 is identified in these documents, initiate a condition report. Minor errors or discrepancies should be promptly corrected in accordance with this procedure.
Failure to identify changes to LBDs and process documents may result in document inaccuracies and may be considered a failure to comply with NRC regulations [e.g., 10 CFR 50.71(e), 10 CFR 72.248].
NOTE The PAD process assumes that the proposed activity has been accepted as safe and effective.
5.2 GENERAL OVERVIEW
[1] The Preparer completes a PAD Form (Attachment 9.1) for a proposed activity to determine the following:
(a) The affect or potential to affect LBDs and processes.
(b) The appropriate regulation to be used to review the proposed activity.
(c) Whether the activity requires review in a 50.59 or 72.48 Evaluation.
[2] Any PAD Form that has been signed and dated by the Preparer prior to the effective date of this procedure revision may be processed for 60 days following the effective date.
[3] Steps within a section of this procedure may be performed out of sequence.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 12 OF 47 Process Applicability Determination
[4] A PAD is not required for:
(a) Editorial or typographical changes to documents or procedures in accordance with EN-AD-101 or site document control processes.
(b) Editorial changes to an LBD as defined in EN-LI-113. For such changes, initiate a Licensing Basis Document Change Request (LBDCR) in accordance with EN-LI-113.
(c) Changes that have been excluded via a Process Applicability Exclusion in accordance with Section 5.4, unless the scope of the procedure is being changed such that the procedure no longer meets the exclusion criteria in Section 5.4.
(d) Changes to those portions of the Inservice Inspection (ISI) and Inservice Testing (IST) programs that are controlled in accordance with 10 CFR 50.55a.
If the proposed activity meets one of the above categories, the Preparer documents this in the applicable change process document (e.g., in the LBDCR Form or on the procedure cover page).
[5] Described in the UFSAR/CFSAR - Implicit and Explicit Descriptions of SSCs in the UFSAR/CFSAR may be implicit or explicit. Changes to SSCs that are not explicitly described in the UFSAR/CFSAR yet clearly can potentially alter the design function or method of performing the function of SSCs that are explicitly described in the UFSAR/CFSAR, are considered implicit descriptions.
[6] Computer generated forms containing the same informational requirements as the PAD Form may be used in lieu of actual procedure forms if confirmed to be consistent with the latest revision of this procedure.
[7] Signatures for the PAD Form may be obtained via:
(a) Electronic processes (e.g., PCRS work tasks, ER processes) provided the signature is traceable to a single person (b) Manual methods (e.g., ink signature)
(c) E-mails (attach to the PAD Form)
(d) Telecommunications
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 13 OF 47 Process Applicability Determination
[8] Preparers and Reviewers must be:
(a) Knowledgeable of the subject being evaluated and any pertinent site-specific processes and LBDs.
(b) Qualified on the use of this procedure in accordance with Section 5.6.
[9] The Preparer ensures that a copy of the completed PAD Form accompanies the evaluated document unless otherwise excluded by this procedure.
[10] LBD and Process Impact Determination by Other Processes Change processes (e.g., engineering changes) that do not require the direct application of this procedure may conduct LBD, process, and regulatory reviews under the guidance of the applicable process without applying this procedure.
[11] If the proposed activity involves relocating information currently contained in LBDs and/or processes identified in Attachment 9.1 to a process not identified, the Preparer must address the acceptability of the relocation in the associated PAD review.
5.3 PROCESS APPLICABILITY DETERMINATION (PAD)
[1] The PAD is documented on a PAD Form (Attachment 9.1).
[2] Use the PAD Form Instructions provided in Attachment 9.2 for completing the PAD Form. Attachment 9.3 contains a flowchart of the PAD process.
[3] A reviewer signature is required for all PADs.
[4] The PAD Form should accompany the associated proposed activity documentation.
5.4 PROCESS APPLICABILITY EXCLUSION NOTE Procedures previously excluded from the 50.59 Review Process and/or the 72.48 Review Process in accordance with previous NMM Procedures ENN-LI-100, ENS-LI-101, and ENS-LI-112 also meet the requirements of Section 5.4.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 14 OF 47 Process Applicability Determination NOTE Process Applicability Exclusions may also be referred to as Programmatic Exclusions and EN-LI-100 Exclusions in other procedures.
NOTE If a procedure is revised such that the procedure no longer meets the Process Applicability Exclusion criteria below, then a new PAD Form needs to be completed for the procedure revision.
[1] Certain procedures may be excluded from the PAD review process. To exclude a procedure from the PAD review process, (a) the procedure is controlled under only one specific regulation as determined in Section V of the PAD Form, and (b) 10 CFR 50.59 and 72.48 are not applicable (i.e., no 50.59 and 72.48 Screening Review in Section VI of the PAD Form is required), and (c) the procedure does not affect or have the potential to affect any of the other processes or LBDs listed in Sections III and IV of the PAD Form.
Perform electronic or manual searches of processes or LBDs, or use the Attachment 9.2 checklist questions, as needed, to determine if the procedure scope can affect any processes or LBDs. If all questions are answered no, then no processes or LBDs are potentially affected.
An example of a procedure that meets this exclusion criteria would be a training program procedure that does not have the potential to impact a process or a LBD and requires review only under 10 CFR 50 Appendix B per Section 4.1.4 of NEI 96-07.
Another example of a procedure that meets this exclusion criteria would be a security procedure that does not have the potential to impact a process or a LBD, other than the security plan, and requires review under 10 CFR 50.54(p) per Section 4.1 of NEI 96-07.
An example of a procedure that does not meet the exclusion criteria would be a procedure that requires review under 10 CFR 50.59 or 72.48.
[2] The Preparer performs a one-time PAD Form on the entire scope of the procedure in accordance with Section 5.3 and documents in the General Review Comments (Section VII.A) how the procedure meets the criteria above. Identify in the General Review Comments section any limitations or requirements that must be met in order for the exclusion to remain valid.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 15 OF 47 Process Applicability Determination
[3] Sign Section VIII of the PAD Form and:
(a) For a site procedure, send it to the Site Procedure Owner for approval.
(b) For an NMM procedure, send it to the Site Procedure Champion for approval.
[4] The Site Procedure Champion / Site Procedure Owner documents approval of the exclusion by signing the appropriate block in Section VIII of the PAD Form and includes a copy of the completed PAD Form with the excluded procedure.
5.5 REVISIONS OF PAD FORMS Revisions to approved PAD Forms require the same level of review as the original.
The Preparer should add a revision number to the PAD Form, and also denote revised information in a conspicuous manner (e.g., hi-lighted text, clouded text, revision bars, etc.).
5.6 QUALIFICATION OF PERSONNEL
[1] Preparers and Reviewers are qualified and requalified in accordance with this procedure.
[2] To become qualified, an individual successfully completes the training activities listed on the Process Applicability Determination Initial Training qualification card, FQC-ADM-PAD06 (fleet curricula F-ADM-SCREENER). The qualification card should be completed within 90 days of completing the initial training. If not, the individual should repeat initial training.
[3] Qualified PAD Preparers and Reviewers must complete requalification training every three years in order to maintain their PAD qualifications. Failure to meet this requalification requirement will result in lapsed qualification for a qualified individual.
[4] An individual may be exempted from qualification or requalification requirements by using the exemption process controlled by EN-TQ-212, Conduct of Training and Qualification. Any person seeking PAD training exemption must receive approval from the site 50.59 Program Coordinator.
[5] Once the individual successfully completes training, the site 50.59 Program Coordinator submits appropriate documentation to training records.
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[6] Refresher training is scheduled as deemed necessary by the site/corporate 50.59 Program Coordinator and/or site management.
[7] Lapsed Qualification (a) Failure to attend or participate in any requalification training, or any refresher training that the 50.59 fleet peer group, site 50.59 program coordinator, or site management deems to be necessary, will result in lapsed qualification for a qualified individual.
(b) An individual whose qualification has lapsed may have his qualification reinstated by completing all required requalification or refresher training given since the date the qualification lapsed.
6.0 INTERFACES
[1] NMM Procedure EN-DC-120, Engineering Code Programs
[2] NMM Procedure EN-DC-128, Fire Protection Impact Reviews
[3] NMM Procedure EN-DC-203, Maintenance Rule Program
[4] NMM Procedure EN-DC-204, Maintenance Rule Scope and Basis
[5] NMM Procedure EN-DC-205, Maintenance Rule Monitoring
[6] NMM Procedure EN-DC-206, Maintenance Rule (A)(1) Process
[7] NMM Procedure EN-DC-207, Maintenance Rule Periodic Assessment
[8] NMM Procedure EN-DC-332, Inservice Testing
[9] NMM Procedure EN-DC-351, Inservice Inspection Program Duties and Responsibilities
[10] NMM Procedure EN-EP-305, Emergency Planning 10 CFR 50.54(q) Review Program
[11] NMM Procedure EN-EV-115, Environmental Reviews and Evaluations
[12] NMM Procedure EN-EV-117, Air Emissions Management Program
[13] NMM Procedure EN-LI-101, 10 CFR 50.59 Evaluations
[14] NMM Procedure EN-LI-102, Corrective Action Process
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 17 OF 47 Process Applicability Determination
[15] NMM Procedure EN-LI-103, Operating License Amendments
[16] NMM Procedure EN-LI-110, Commitment Management Program
[17] NMM Procedure EN-LI-112, 10 CFR 72.48 Evaluations
[18] NMM Procedure EN-LI-113, Licensing Basis Document Change Process
[19] NMM Procedure EN-MA-133, Control of Scaffolding
[20] NMM Procedure EN-NS-210, 10 CFR 50.54(p) Review Program
[21] NMM Procedure EN-OP-102-01, Protective and Caution Tagging Forms &
Checklist
[22] NMM Procedure EN-OP-104, Operability Determination Process
[23] NMM Procedure EN-QV-104, Quality Assurance Program Manual Control
[24] NMM Procedure EN-RP-110, ALARA Program
[25] NMM Procedure EN-RW-105, Process Control Program
[26] NMM Procedure EN-TQ-212, Conduct of Training and Qualification 7.0 RECORDS
[1] Process Applicability Determination (PAD) Form 8.0 SITE-SPECIFIC COMMITMENTS Step Site Document Commitment Number or Reference All GGNS QAPM A.1.d P-33616
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 18 OF 47 Process Applicability Determination 9.0 ATTACHMENTS NOTE The PAD Form (EN-LI-100-ATT-9.1) is available in the eB Reference Library (ECH site) under Nuclear Management Manual/NMM Forms.
9.1 Process Applicability Determination Form 9.2 PAD Form Instructions 9.3 PAD Process Flowchart
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 19 OF 47 Process Applicability Determination ATTACHMENT 9.1 PROCESS APPLICABILITY DETERMINATION FORM Sheet 1 of 7 I. OVERVIEW PAD Rev. #:
Facility:
Proposed Activity / Document: Change/Rev. #:
Description of Proposed Activity:
II. DOCUMENT REVIEW Provide the requested information for each item below.
- 1. For documents available electronically:
- a. List search engine or documents searched, and keywords used:
- b. List relevant sections of controlled electronic documents reviewed:
- 2. Documents reviewed manually (hardcopy):
- 3. For those documents that are not reviewed either electronically or manually, use the specific questions provided in Sections III and IV of Attachment 9.2 of EN-LI-100 as needed. Document below the extent to which the Attachment 9.2 questions were used.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 20 OF 47 Process Applicability Determination ATTACHMENT 9.1 PROCESS APPLICABILITY DETERMINATION FORM Sheet 2 of 7 III. PROCESS REVIEW Does the proposed activity affect, invalidate, or render incorrect, OR have the potential to affect, invalidate, or render incorrect, information contained in any of the following processes? Associated regulations and procedures are identified with each process below.
PROCESS (Regulations / Procedures) YES NO REVIEW RESULTS Chemistry / Effluents Radwaste / Process Control Program (PCP)
(EN-RW-105 or contact the Radiation Protection Dept.)
Radiation Protection / ALARA (10 CFR 20 / EN-RP-110 or contact the Radiation Protection Dept.)
Inservice Inspection Program (10 CFR 50.55a / EN-DC-120, -351)
Inservice Testing Program (10 CFR 50.55a / EN-DC-332)
Maintenance Rule Program (10 CFR 50.65 / EN-DC-203, -204, -205, -206,
-207)
Containment Leakage Rate Testing (Appendix J) Program (10 CFR 50 Appendix J / EN-DC-334)
IF any box is checked Yes, THEN contact the appropriate department to ensure that the proposed change is acceptable and document the results in the REVIEW RESULTS column.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 21 OF 47 Process Applicability Determination ATTACHMENT 9.1 PROCESS APPLICABILITY DETERMINATION FORM Sheet 3 of 7 IV. LICENSING BASIS DOCUMENT REVIEW Does the proposed activity affect, invalidate, or render incorrect, OR have the potential to affect, invalidate, or render incorrect, information contained in any of the following Licensing Basis Document(s)? Associated regulations and procedures are identified with each Licensing Basis Document below.
LICENSING BASIS DOCUMENTS YES NO REVIEW RESULTS OR SECTIONS (Regulations / Procedures) AFFECTED OR LBDCR #
Quality Assurance Program Manual (QAPM)
Fire Protection Program (FPP) [includes the Fire Safety Analysis/Fire Hazards Analysis (FSA/FHA)]
OL Condition, 10 CFR 50.48 / EN-DC-128)
Emergency Plan (10 CFR 50.54(q) / EN-EP-305)
Environmental Protection Plan (Appendix B of the OL, Environmental Evaluation / EN-EV-115, EN-EV-117, EN-LI-103)
Security Plan and Cyber Security Plan
[10 CFR 50.54(p) / EN-NS-210 or contact the site Security / IT Dept.]
Operating License (OL) / Technical Specifications (TS) *
TS Bases (10 CFR 50.59 / EN-LI-100 / EN-LI-101)
Technical Requirements Manual (TRM) (including TRM Bases)
(10 CFR 50.59 / EN-LI-100 / EN-LI-101)
Core Operating Limits Report (COLR), and Pressure and Temperature Limits Report (PTLR) (TS Administrative Controls, EN-LI-113, EN-LI-100, EN-LI-101)
Offsite Dose Calculation Manual (ODCM)
(TS Administrative Controls or 10 CFR 50.59 / EN-LI-113 or EN-LI-100 / EN-LI-101)
Updated Final Safety Analysis Report (UFSAR)
(10 CFR 50.71(e) / EN-LI-113, EN-LI-100, EN-LI-101)
Storage Cask Certificate of Compliance (10 CFR 72.244 / EN-LI-113)
(10 CFR 72.70 or 72.248 / EN-LI-113, EN-LI-100,EN-LI-112) 10 CFR 72.212 Evaluation Report (212 Report)
(10 CFR 72.48 / EN-LI-100, EN-LI-112)
NRC Orders (10 CFR 50.90 / EN-LI-103 or as directed by the Order)
- NRC Commitments and Obligations (EN-LI-110)
- Site Specific CFR Exemption *
(10 CFR 50.12, 10 CFR 55.11, 10 CFR 55.13, 10 CFR 72.7)
- Contact the site Licensing Department.
IF any box is checked Yes, THEN ensure that any required regulatory reviews are performed in accordance with the referenced procedures. Prepare an LBDCR per procedure EN-LI-113 if a LBD is to be changed, and document any affected sections or the LBDCR #. Briefly discuss how the LBD is affected in Section VII.A.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 22 OF 47 Process Applicability Determination ATTACHMENT 9.1 PROCESS APPLICABILITY DETERMINATION FORM Sheet 4 of 7 V. 10 CFR 50.59 / 10 CFR 72.48 APPLICABILITY Can the proposed activity be dispositioned by one of the following criteria? Check the appropriate box (if any).
An approved, valid 50.59/72.48 Evaluation covering associated aspects of the proposed activity already exists. Reference 50.59/72.48 Evaluation # __________________ (if applicable) or attach documentation. Verify the previous 50.59/72.48 Evaluation remains valid.
The NRC has approved the proposed activity or portions thereof or a license amendment being reviewed by the NRC addresses the proposed activity. Reference the approval document: ______________________________________________________________
The proposed activity is controlled by one or more specific regulations.
Examples of specific regulations are:
- Maintenance Rule (50.65),
- Quality Assurance Program (10 CFR 50 Appendix B)
- Security Plan (50.54(p))
- Emergency Plan (50.54(q))
- Fire Protection (operating license condition)
See NEI 96-07 Section 4.1 for additional guidance on specific regulations.
Reference the controlling specific regulation(s):
IF the entire proposed activity can be dispositioned by the criteria in Section V, THEN proceed to Section VII and provide basis for conclusion in Section VII.A.
Otherwise, continue to Section VI to perform a 50.59 and/or 72.48 Screening, or perform a 50.59 and/or 72.48 Evaluation in accordance with EN-LI-101 and/or EN-LI-112.
Changes to the IPEC Unit 1 Decommissioning Plan are to be evaluated in accordance with the 50.59 process, as allowed by the NRC in a letter to IPEC dated January 31, 1996. [IPEC-1 Letter RA960014]
Sheet 5 of 7
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 23 OF 47 Process Applicability Determination ATTACHMENT 9.1 PROCESS APPLICABILITY DETERMINATION FORM VI. 50.59 / 72.48 SCREENING REVIEW VI.A 50.59/72.48 SCREENING (Check the appropriate boxes.)
10 CFR 50.59 Screening criteria are met. [10 CFR 50.59(c)(1)]
The proposed activity meets all of the following criteria regarding design function:
- Does not adversely affect a method of performing or controlling a design function of an SSC as described in the UFSAR; AND
- Does not adversely affect a method of evaluation that demonstrates intended design function(s) of an SSC will be accomplished as described in the UFSAR; AND
- Does not involve a test or experiment not described in the UFSAR.
The proposed activity does not involve structures, systems, or components controlled by 10 CFR 50.59.
10 CFR 72.48 Screening criteria are met. [10 CFR 72.48(c)(1)] (Applicable to sites with an ISFSI)
The proposed activity meets all of the following criteria regarding design function:
- Does not adversely affect a method of performing or controlling a design function of an SSC as described in the CFSAR; AND
- Does not adversely affect a method of evaluation that demonstrates intended design function(s) of an SSC will be accomplished as described in the CFSAR; AND
- Does not involve a test or experiment not described in the CFSAR.
The proposed activity does not involve structures, systems, or components controlled by 10 CFR 72.48.
IF either of the 50.59 or 72.48 Screening criteria are met, THEN complete VI.B below as appropriate and proceed to Section VII.
IF the proposed activity does not meet the applicable criteria, THEN perform a 50.59 or 72.48 Evaluation in accordance with EN-LI-101 or EN-LI-112, as appropriate, attach a copy of the Evaluation to this form, and proceed to Section VII.
IF the activity does not involve systems, structures, or components controlled by 10 CFR 50.59 or by 10 CFR 72.48, THEN a 50.59 or 72.48 Screening is not required, as appropriate, and proceed to Section VII.
Sheet 6 of 7 VI.B BASIS
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 24 OF 47 Process Applicability Determination ATTACHMENT 9.1 PROCESS APPLICABILITY DETERMINATION FORM Provide a clear, concise basis for determining the proposed activity may be screened out such that a third-party reviewer can reach the same conclusions. Refer to NEI 96-07 Section 4.2 for guidance.
Provide supporting documentation or references as appropriate.
VII. REGULATORY REVIEW
SUMMARY
VII.A GENERAL REVIEW COMMENTS (Provide pertinent review details and basis for conclusions if not addressed elsewhere in form.)
VII.B CONCLUSIONS
- 1. Is a change to an LBD being initiated? Yes IF Yes, THEN enter the appropriate change control process and include No this form with the change package.
- 2. Is a 10 CFR 50.59 Evaluation required? Yes IF Yes, THEN complete a 50.59 Evaluation in accordance with EN-LI-101 No and attach a copy to the change activity.
- 3. Is a 10 CFR 72.48 Evaluation required? Yes IF Yes, THEN complete a 72.48 Evaluation in accordance with EN-LI-112 No and attach a copy to the change activity.
Sheet 7 of 7
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 25 OF 47 Process Applicability Determination ATTACHMENT 9.1 PROCESS APPLICABILITY DETERMINATION FORM VIII. SIGNATURES 1 Preparer:
Name (print) / Signature / Company / Department / Date Reviewer:
Name (print) / Signature / Company / Department / Date Process Applicability Exclusion Site Procedure Champion or Name (print) / Signature / Company / Department / Date Owner:
Upon completion, forward this PAD form to the appropriate organization for record storage. If the PAD form is part of a process that requires transmittal of documentation, including PAD forms, for record storage, then the PAD form need not be forwarded separately.
1 Signatures may be obtained via electronic processes (e.g., PCRS, ER processes, Asset Suite signature),
manual methods (e.g., ink signature), e-mail, or telecommunication. If using an e-mail , attach it to this form.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 26 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 1 of 20 I. OVERVIEW PAD Rev. #:
Facility: ____________________________________ Insert the facility and unit number, as applicable.
Proposed Activity / Document: ________________________________ Change/Rev. #: _________
Provide the document title and designating number (e.g., ER number and title, procedure number and title). The Change/Rev. #, where applicable, should be the new change or revision number that will be assigned when the document is updated in accordance with the PAD.
Description of Proposed Activity:
This section can be any length, but should clearly provide a description of the change including the areas that have potential effect on licensing basis documents. It should describe the context of what is being changed in order that a third party reviewer can understand potential effect on the design function, operation, and/or evaluation of a structure, system, or component (SSC). The following should be included in the
Description:
- Clear description of the specifics of the proposed change presented in a summarization of the activity (i.e., not a list of every change but an overall description)
- Acronyms or component numbers if used (provide their noun names at least once)
If the proposed activity involves a Process Applicability Exclusion, the Preparer should clearly indicate this in the Description. The scope of the document being excluded should be clearly identified here.
General Guidance:
- 1. If at anytime in a PAD Review, the Preparer is uncertain how to address the approach or complexity of the proposed activity, he should seek additional guidance or contact the sites 50.59 Program Coordinator.
- 2. If a Preparer is aware of recent regulatory issues that could affect the results of a PAD Review, he should contact the sites 50.59 Program Coordinator to seek additional guidance.
- 3. Guidance for performing PAD Reviews for compensatory measures for degraded or nonconforming conditions is provided in EN-OP-104, Operability Determination Process.
- 4. Guidance for performing PAD Reviews for tagouts is provided in EN-OP-102-01, Protective and Caution Tagging Forms & Checklist.
- 5. Requirements for performing PAD Reviews of scaffolding are provided in EN-MA-133, Control of Scaffolding.
II. DOCUMENT REVIEW Provide the requested information for each item below.
The Preparer should review, as deemed appropriate, LBDs, process documents, and other references that could potentially be associated with the activity when completing the PAD Review. Documents can be reviewed either electronically or manually, or the questions in Attachment 9.2 may be used when
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 27 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 2 of 20 completing the PAD Review. Electronic or manual searches of the Final Safety Analysis Report for the HI-STORM 100 Cask System (CFSAR),and Certificate of Compliance (COC), should also be made of the revision that the site is committed to.
When performing an LBD search, the Preparer should search not only the source document, but also any pending changes to the document. The Preparer may contact the site licensing department for assistance in searching pending changes.
- 1. For documents reviewed electronically:
- a. List search engine or documents searched, and keywords used:
- b. List relevant sections of controlled electronic documents reviewed:
For Item 1.a, identify the electronic search method used and/or individual LBDs searched electronically.
Identify the appropriate designation for your site (e.g., 50.59-Search) that bins the LBDs into one search category if using the Autonomy search engine. This should reflect all appropriate keywords necessary to detect potential LBD hits.
The Preparer should review the document to investigate the results of the electronic search. In cases where there are no electronic hits, the Preparer should review document sections (using either an electronic copy or a hard copy) he/she thinks may contain pertinent information to identify any potential implicit effect to information.
For plants that use the Autonomy electronic search engine, an Autonomy Users Guide is available via the Autonomy Help button. While Autonomy is a good tool to use for finding documentation related to a proposed change, Autonomy is not controlled at all sites. Therefore, controlled documents must be reviewed when assessing impacts.
For Item 1.b, list the controlled documents electronically reviewed where relevant hits were noted in Item 1.a. If no Item 1.a hits were found to be relevant to the change, state this conclusion in response to Item 1.b.
Electronic copies of LBDs can be viewed on the applicable sites electronic library (e.g., eB Reference Library, MERLIN) or through the use of Autonomy, where available. The QAPM is found on eB Reference Library at the Echelon site.
- 2. Documents reviewed manually (hardcopy)
List the LBDs and associated sections manually reviewed using a controlled hardcopy of the document.
The Preparer should state None or similar if no hardcopies were required to be reviewed for the given change.
- 3. For those documents that are not reviewed either electronically or manually, use the specific questions provided in Sections III and IV of Attachment 9.2 of EN-LI-100 as needed. Document below the extent to which the Attachment 9.2 questions were used.
The questions in Attachment 9.2 may be used when completing the PAD form. These questions are particularly useful for LBDs that are not readily available. The Security Plan is a prime example, since a special clearance is required to review it. In these cases, the Preparer should use the questions for the document that are provided in Sections III and IV of these PAD Form Instructions. If these questions are used, indicate which document(s) were reviewed using them.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 28 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 3 of 20 III. PROCESS REVIEW Does the proposed activity affect, invalidate, or render incorrect, OR have the potential to affect, invalidate, or render incorrect, information contained in any of the following processes?
Associated regulations and procedures are identified with each process below. Specific questions are provided for each process to assist the Preparer in answering this question.
PROCESS (Regulations / Procedures) YES NO REVIEW RESULTS Chemistry / Effluents Does the proposed activity affect or produce a change in:
- 1. Effluent releases or paths (including discharge permit or wastewater treatment concerns?
- 2. Installed or portable chemical monitoring systems?
- 3. Any radioactive effluent or monitoring process or system?
- 4. New or existing chemical usage?
- 5. Radioactivity/chemical vapor pathway affecting Control Room habitability?
Radwaste / Process Control Program (PCP)
(EN-RW-105 or contact the Radiation Protection Dept.)
Does the proposed activity:
- 1. Cause a change to the solid radioactive waste processing system?
- 2. Adversely affect the current capacity of the solid radioactive waste processing system?
- 3. Involve or change calculations or assumptions concerning liquid or solid radioactive waste processing systems?
- 4. Affect systems described in the UFSAR as governed by the Process Control Program?
Radiation Protection / ALARA (10 CFR 20 / EN-RP-110 or contact the Radiation Protection Dept.)
Does the proposed activity:
- 1. Cause a change in the radiological conditions inside or outside radiologically controlled areas?
- 2. Adversely affect the monitoring of radiological conditions?
- 3. Involve or change calculations or assumptions concerning plant radiological conditions following a design basis accident?
- 4. Affect ALARA issues such as change of radiation sources, increase time in a radiation area, change containment of a radiation source, or change shielding of a radiation source?
- 5. Involve establishing a Radiological Controlled Area outside the restricted area?
Inservice Inspection Program (10 CFR 50.55a / EN-DC-120, -351)
Does the proposed activity affect:
- 1. Any ISI pressure boundary (piping, support, component, valve, flange, etc.) within the ISI Class 1, 2, or 3/3A boundary as detailed in ISI drawings?
- 2. The containment structure?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 29 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 4 of 20 Inservice Testing Program (10 CFR 50.55a / EN-DC-332)
Does the proposed activity affect any pump or valve in the IST Program?
Maintenance Rule Program (10 CFR 50.65 / EN-DC-203, -204, -205, -206,
-207)
Does the proposed activity add or remove:
- 1. A safety-related system, structure, or component (SSC)?
- 2. Non-safety-related SSCs that mitigate accidents and transients?
- 3. Non-safety-related SSCs that are used in the emergency operating procedures (EOPs) or EOP safety-related function(s)?
- 4. Non-safety-related SSCs whose failure could prevent safety-related SSCs from fulfilling their safety-related function(s)?
Containment Leakage Rate Testing (Appendix J) Program (10 CFR 50 Appendix J / EN-DC-334)
Does the proposed activity affect:
- 1. Components serving as containment isolation?
- 2. Containment penetration assemblies, doors, and hatches?
- 3. Qualified seal water system? (IPEC Only)
IF any box is checked Yes, THEN contact the appropriate department to ensure that the proposed activity is acceptable and document the results in the REVIEW RESULTS column.
- 1. If a process is affected, contact the appropriate Process Owner and ensure required actions are taken (the proposed activity cannot be implemented until the Process Owner acknowledges the required actions to address the effect).
- 2. The Process Owner may be contacted by e-mail, memorandum, ER or Engineering Change (EC) action, or phone; however, adequate documentation for process effect acknowledgment should be confirmed prior to implementation.
- 3. Document the process effect and the actions being taken by the Process Owner in the REVIEW RESULTS column.
IV. LICENSING BASIS DOCUMENT REVIEW
- 1. Identified editorial changes to LBDs do not require a PAD Review as discussed in Section 5.2 [4] of EN-LI-100.
- 2. Changes to procedures that are determined to be editorial can be excluded from the PAD process in accordance with EN-AD-101 and site procedure control processes.
- 3. UFSAR/CFSAR statements that direct the Preparer to a separate document (ER, calculation, vendor topical report, EPRI document, etc.) to find the specific information is classified as UFSAR/CFSAR information Incorporated by Reference. This change will likely require a revision to the referenced document, but will not require a change to the LBD since there is no physical change to the LBD.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 30 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 5 of 20 Does the proposed activity affect, invalidate, or render incorrect, OR have the potential to affect, invalidate, or render incorrect, information contained in any of the following Licensing Basis Document(s)? Associated regulations and procedures are identified with each Licensing Basis Document below. Specific questions are provided for each LBD to aid the Preparer in answering this question.
LICENSING BASIS DOCUMENTS YES NO REVIEW RESULTS OR SECTIONS (Regulations / Procedures) AFFECTED OR LBDCR #
Apply the appropriate change control process that is identified in the If any box is checked YES, then identify parentheses. The change control documentation (e.g. 50.59 Forms, 50.54 the LBD sections affected or the LBDCR reviews, etc.) should be attached along with the PAD form in the change number if a LBD is affected. Briefly package (e.g., procedure change, EC, etc.). describe the results of any required regulatory reviews or other reviews. If all boxes are checked NO, then only the PAD Form is required to be attached to the source document.
Quality Assurance Program Manual (QAPM)
Does the proposed activity:
- 1. Affect the authority, independence, or management reporting levels previously established for organizations performing quality assurance functions as described in the QAPM?
- 2. Reduce commitments or the effectiveness of the Quality Assurance functions specifically described in the QAPM?
- 4. Delete or contradict any regulatory requirement listed in the QAPM as modified by Table 1 of the QAPM?
- 5. Require a Quality-Related procedure revision, which would delete or reduce, a QAPM reference listed in the procedure?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 31 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 6 of 20 Fire Protection Program (FPP) [includes the Fire Safety Analysis /Fire Hazards Analysis (FSA/FHA)]
(OL Condition, 10 CFR 50.48 / EN-DC-128)
Even if the FPP/FSA/FHA is part of the UFSAR, impact reviews will be performed under EN-DC-128.
The following questions should be considered in light of the impact on the FPP/FSA/FHA (i.e., will a change to the site LBD be required). If an FPP LBD (normally the FSA/FHA) is not impacted by the change, then the box should be checked NO. Other site processes govern changes to non-LBD documents (such as implementing procedures) and ensure responsible Fire Protection personnel review and approve FPP-related changes when applicable. (CR-ANO-C-2007-1256)
Does the proposed activity:
- 1. Affect any fire protection systems, components, or features including fire pumps, tanks, piping, valves, hydrants, extinguishers, hose stations, sprinklers/nozzles, smoke/heat/flame detectors, control panels, cables, fire seals, fire doors, heat or smoke vents, fire dampers, interior finishing, roofing material, etc.?
- 2. Affect any fire protection safe shutdown or nuclear safety capability assessment credited components including cables, cable wraps, separation barriers, communication equipment, Appendix R repair kits, portable ventilation equipment, emergency lights, or the reactor coolant pump oil collection system?
- 3. Affect any physical changes to areas protected by fire suppression or detection systems which could adversely affect system performance such as changes to ceiling configuration, air distribution patterns, addition or deletion of openings into a gaseous protected enclosure, addition of obstructions below sprinklers/nozzles which may affect spray patterns, etc.?
- 4. Permanently change the combustible load due to the addition or removal of flammable or combustible materials, including the addition of new ignition sources (Pumps, motors, electrical cabinets, permanently installed batteries, diesel generators, air compressors, battery chargers, switchgear, etc)?
- 5. Affect spill control features such as dikes, curbs, or floor drains in plant areas governed by the fire protection license basis?
- 6. Affect the administrative elements of the Fire Protection Program such as the safe shutdown strategy, Fire Protection Impact Reviews EN-DC-128 (CR-WF3-3012-863), nuclear safety capability assessment, fire brigade training or equipment, fire protection surveillance procedures, etc.?
- 7. Block ingress/egress to any fire protection equipment including obstruction of emergency lights or operator action pathways?
- 8. Add, modify or remove a structure, cooling tower fill or cooling tower supports under property insurance coverage?
- 9. Affect smoke ventilation/HVAC equipment in plant areas governed by the fire protection license basis?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 32 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 7 of 20 Emergency Plan (10 CFR 50.54(q) / EN-EP-305)
The following questions should be considered in light of the impact on the site LBD for the Emergency Plan (i.e., will a change to the site LBD be required). If an Emergency Plan LBD is not impacted by the change, then the box should be checked NO. Other site processes govern changes to non-LBD documents (such as implementing procedures) and ensure responsible EP personnel review and approve EP-related changes when applicable.
Does the proposed activity:
- 1. Change responsibilities described in the Emergency Plan or Emergency Plan implementing procedures?
- 2. Affect or cause a modification (permanent or temporary) to structures, systems, or components or to software or to equipment that affects or is described in the Emergency Plan?
- 3. Affect offsite assistance or agreements or any offsite facilities used in the Emergency Plan?
- 4. Affect onsite staffing, Emergency staffing, equipment, or operations referred to in the Emergency Plan?
- 5. Affect the design or operation of the meteorological system / public alert notification system, effluent radiological monitoring systems, ventilation systems, or communication systems?
- 6. Affect the data-reporting activities or peripherals of any data collection system [e.g., Meteorological Information Data Acquisition System, Safety Parameter Display System (SPDS), Emergency Response Facility Information System (ERFIS), Data Point Library (DPL)]?
- 7. Affect any Emergency Action Level (EAL) bases or values?
- 8. Affect any changes or additions to external structures surrounding the plant that may create radiological, security, toxic, or explosive concerns?
- 9. Affect protective actions, equipment, evacuation, accountability, exposure control, or onsite personnel?
- 10. Affect emergency public information programs and/or capabilities?
- 11. Affect Emergency Response Organization training, drills/exercises, or Emergency Plan reviews and updates?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 33 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 8 of 20 Environmental Protection Plan (Appendix B of the OL, Environmental Evaluation / EN-EV-115, EN-EV-117, EN-LI-103)
ANO, JAF, PNPS, and VY do not have Environmental Protection Plans.
The following questions should be considered in light of the impact on the site LBD for the Environmental Protection Plan (i.e., will a change to the site LBD be required). If an Environmental Protection Plan LBD is not impacted by the change, then the box should be checked NO. Other site processes govern changes to non-LBD documents (such as implementing procedures) and ensure responsible personnel review and approve related Environmental Protection changes when applicable.
Does the proposed activity involve:
- 1. 1.A land disturbance equal to or greater than one acre (i.e., grading activities, construction of buildings, excavations, reforestation, creating or removing ponds)?
- 2. Any land disturbance of undisturbed surface or subsurface land areas (i.e., grading activities, construction, excavations, reforestation, creating or removing ponds)?
- 3. Dredging activities in a lake, river, ocean, ditch, pond, or stream?
- 4. Changing the amount of thermal heat being discharged to a river, ocean, or lake (i.e., associated with once-through and closed cycle cooling wastewater discharges)?
- 5. Changing the concentration or quantity of chemicals being discharged to a river, ocean, lake, or air (i.e., associated with wastewater and air emission discharges)?
- 6. Discharging new or different chemicals that are currently not authorized for use by the state or federal regulatory agency (i.e., associated with wastewater discharges)?
- 7. Changing the design or operation of the intake or discharge structures (i.e., associated with wastewater discharges)?
- 8. Modifying the design or operation of the cooling tower that will change water or air flow characteristics?
- 9. Modifying the design or operation of the plant that will change the path of an existing water discharge or that will result in a new water discharge (i.e., associated with wastewater discharges)?
- 10. Modifying existing stationary fuel burning equipment that could potentially result in an increase of air emissions (i.e., diesel fuel oil, 1
butane, gasoline, propane, and kerosene)?
- 11. Installing or removing stationary fuel burning equipment or using portable fuel burning equipment (i.e., diesel fuel oil, butane, gasoline, 1
propane, and kerosene)?
- 12. Installing or using of equipment that will result in an air emission discharge (i.e., ozone, VOC, particulates, sulfur dioxide, carbon monoxide, nitrogen oxide)?
- 13. Installing or modifying a stationary or mobile tank (i.e., fuel oil, gasoline, kerosene, propane, butane, sulfuric acid)?
- 14. Using or storing oils or chemicals in containers 55 gallons that could be directly released into the environment?
- 15. Burial or placement of any solid wastes in the site area that may affect runoff, surface water, or groundwater?
- 16. Generating a new hazardous waste stream or increase the quantity of an existing hazardous waste stream?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 34 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 9 of 20 Security Plan and Cyber Security Plan
[10 CFR 50.54(p) / EN-NS-210 or contact the site Security / IT Dept.]
The Security Plan is not electronically accessible; therefore, these questions should be used to determine effect on the plan.
The following questions should be considered in light of the impact on the site LBD for the Security Plan (i.e., will a change to the site LBD be required). If a Security Plan LBD is not impacted by the change, then the box should be checked NO. Other site processes govern changes to non-LBD documents (such as implementing procedures) and ensure responsible Security personnel review and approve Security-related changes when applicable.
Does the proposed activity:
- 1. Add, delete, modify, or otherwise affect Security department responsibilities (e.g., including fire brigade, fire watch, and confined space rescue operations)?
- 2. Result in a breach to any security barrier(s) (e.g., HVAC ductwork, fences, doors, walls, ceilings, floors, penetrations, and ballistic barriers)?
- 3. Could the proposed change or activity decrease the effectiveness of NRC-approved security plans or invalidate the site protective strategy (e.g., communications, response timelines and pathways, equipment and systems (particularly target sets), or protected fighting positions and fields of fire)?
- 4. Cause materials or equipment to be placed or installed within the Security Isolation Zone?
- 5. Affect security lighting by adding or deleting lights, structures, buildings, or temporary facilities?
- 6. Modify or otherwise affect the intrusion detection systems (e.g., E-field microwave, fiber optics)?
- 7. Modify or otherwise affect the operation or field of view of the security cameras?
- 8. Modify or otherwise affect (block, move, or alter) installed access control equipment or intrusion detection equipment (i.e., interior and exterior sensors, zone of detection and field of view, alarm communications, or access control systems) and assessment functions?
- 9. Modify or otherwise affect primary or secondary power supplies to access control equipment or intrusion detection equipment or to the Central Alarm Station or the Secondary Alarm Station
- 10. Could the proposed change or activity increase response times of emergency or armed security personnel (e.g., manmade or natural and active or passive vehicle barriers, vehicle access control and channeling barriers, access delay systems, exterior (protected area) delay barriers, interior delay barriers (passive, active, or dispensable))?Modify or otherwise affect the facilitys land vehicle barriers including access roadways?
- 11. Could the proposed change or activity reduce adversary task times?
- 12. Could the proposed change or activity result in noncompliance with the NRCs security regulations?
- 13. Modify or otherwise affect the facilitys telephone or security radio systems?
- 14. Could the proposed change or activity increase the numbers of, change configurations of, or create a new target set(s) from those previously evaluated?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 35 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 10 of 20
- 15. Does the proposed activity invalidate, render incorrect, or otherwise require a change to the Cyber Security Plan?
Operating License (OL) / Technical Specifications (TS) *
Does the proposed activity invalidate, render incorrect, or otherwise require a change to an existing Technical Specification or the Operating License?
If NRC is reviewing a change that still requires a 50.59 Evaluation for a package, then this box would then be checked NO since NRC review is in progress.
TS Bases (10 CFR 50.59 / EN-LI-100 / EN-LI-101)
Does the proposed activity:
- 1. Invalidate or render incorrect information in the TS Bases?
- 2. Require a change to the TS Bases?
Technical Requirements Manual (TRM) (including TRM Bases)
(10 CFR 50.59 / EN-LI-100 / EN-LI-101)
Does the proposed activity:
- 1. Invalidate or render incorrect information in the TRM?
- 2. Require a change to the TRM?
Core Operating Limits Report (COLR), and Pressure and Temperature Limits Report (PTLR) (TS Administrative Controls, EN-LI-113, EN-LI-100, EN-LI-101)
Does the proposed activity involve changes, tasks, or evolutions that could potentially affect the control of core reactivity or affect calorimetric or core monitoring instrumentation?
Does the activity involve changes, tasks, or evolutions that could affect the primary coolant system or reactor cooling system pressure temperature limits for heatup, cooldown, low temperature operation, criticality, hydrostatic testing, or heatup and cooldown rates?
Offsite Dose Calculation Manual (ODCM)
(TS Administrative Controls or 10 CFR 50.59 / EN-LI-113 or EN-LI-100 / EN-LI-101)
Does the proposed activity affect:
- 1. Radioactive liquid or gaseous effluents?
- 2. Radioactive liquid or gaseous effluent monitoring?
- 3. Radiological Environmental Monitoring?
Updated Final Safety Analysis Report (UFSAR)
(10 CFR 50.71(e) / EN-LI-113, EN-LI-100, EN-LI-101)
Does the proposed activity:
- 1. Invalidate or render incorrect information in the UFSAR?
- 2. Require a change to the UFSAR?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 36 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 11 of 20 Storage Cask Certificate of Compliance (10 CFR 72.244 / EN -LI-113)
- If the NRC is reviewing a change that still requires 72.48 approval for a package, then go to EN-LI-112, Section 1, Validity Question check Yes, and follow that guidance. This box would then be checked No since NRC review is in progress.
The following questions should be considered in light of the impact on the COC (i.e., will a change to the COC be required). If the COC is not impacted by the change, then NO should be marked above.
Does the proposed activity:
- 1. Involve any activity that directly affects spent fuel cask storage or loading operations?
- 2. Involve the ISFSI including the concrete pad, security fence, and lighting?
- 3. Involve a change to the on-site transport equipment or path from the Fuel Building to the ISFSI?
- 4. Involve a change to the design or operation of the Fuel Building fuel bridge including setpoints and limit switches?
- 5. Involve a change to the Fuel Building/Fuel Handling Area or Control Room(s) radiation monitoring?
- 6. Involve a change to the Fuel Building pools including pool levels, cask pool gates, cooling water sources, and water chemistry?
- 7. Involve a change to the Fuel Building handling equipment (e.g., bridges and cask cranes, structures, load paths, lighting, auxiliary services, etc)?
- 8. Involve a change to the Fuel Building electrical power that could potentially affect cask loading or storage activities?
- 9. Involve a change to the Fuel Building ventilation that could potentially affect cask loading or storage activities?
- 10. Involve a change to the ISFSI security?
- 11. Involve a change to off-site radiological release projections from non-ISFSI sources?
- 12. Involve a change to spent fuel characteristics?
- 13. Redefine/change heavy load pathways?
- 14. Involve fire and explosion protection near or in the on-site transport paths or near the ISFSI?
- 15. Involve a change to the loading bay or supporting components power that could potentially affect cask loading or storage activities?
- 16. Involve new structures near the ISFSI?
- 17. Involve modifications to any plant systems that support dry fuel storage activities?
18 Involve a change to the nitrogen supply, service air, demineralized water or borated water system in the Fuel Building?
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 37 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 12 of 20 Cask FSAR (CFSAR) (including the CTS Bases)
(10 CFR 72.70 or 72.248 / EN-LI-113, EN-LI-100,EN-LI-112)
Refer to Storage Cask Certificate of Compliance guidance above.
10 CFR 72.212 Evaluation Report (212 Report)
(10 CFR 72.48 / EN-LI-100, EN-LI-112)
Refer to Storage Cask Certificate of Compliance guidance above.
NRC Orders (10 CFR 50.90 / EN-LI-103 or as directed by the Order)
- Does the proposed activity invalidate, render incorrect, or otherwise require a change to an existing NRC Order?
NRC Commitments and Obligations (EN-LI-110)
- Does the proposed activity modify or delete a commitment or obligation?
Site Specific CFR Exemption *
(10 CFR 50.12, 10 CFR 55.11, 10 CFR 55.13, 10 CFR 72.7)
Does the proposed activity invalidate the bases for any existing exemption from NRC requirements?
- Contact the site Licensing Department.
IF any box is checked Yes, THEN ensure that any required regulatory reviews are performed in accordance with the referenced procedures. Prepare an LBDCR per procedure EN-LI-113 if a LBD is to be changed, and document any affected sections or the LBDCR #. Briefly discuss how the LBD is affected in Section VII.A.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 38 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 13 of 20 V. 10 CFR 50.59 / 10 CFR 72.48 APPLICABILITY This section determines whether the activity requires review under 50.59 and/or 72.48 or whether the activity requires review under a specific regulation.
Can the proposed activity, or portion thereof, be dispositioned by one of the following criteria?
Check the appropriate box (if any).
An approved, valid 50.59/72. Evaluation covering associated aspects of the proposed activity already exists. Reference 50.59/72.48 Evaluation # (if applicable) or attach documentation. Verify the previous 50.59/72.48 Evaluations remains valid.
If an existing 50.59/72.48 Evaluation is used, it must be reviewed to ensure:
(1) It covers the proposed scope and activity, and (2) Subsequent changes to licensing basis documents have not affected the previous 50.59/72.48 Evaluation.
If a portion of the proposed activity is not covered by the existing 50.59/72.48 Evaluation, the Preparer must evaluate that portion. The Evaluation number is be referenced or a copy of the approved 50.59/72.48 Evaluation attached to the PAD Form. This only applies to 50.59/72.48 Evaluation references.
The NRC has approved the proposed activity or portions thereof or a license amendment is under NRC review that addresses the proposed activity. Reference the approval document:
If this criterion is used, the Preparer must list a reference to document formal NRC approval of the proposed activity (e.g., SER section, TS amendment number, 10 CFR rule change, etc.) for the specific unit and conditions. NRC Inspection Reports do not constitute NRC approval. Discuss if the subsequent changes have affected the LBDs since the approved document was issued. If a portion of the proposed activity has not been approved, the Preparer must evaluate that portion.
The proposed activity is controlled by one or more specific regulations.
Examples of specific regulations are:
- Maintenance Rule (50.65),
- Quality Assurance Program (10 CFR 50 Appendix B)
- Security Plan (50.54(p))
- Emergency Plan (50.54(q))
- Fire Protection (operating license condition)
See NEI 96-07 Section 4.1 for additional guidance on specific regulations.
Reference the controlling specific regulation(s):
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 39 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 14 of 20 If the proposed activity is controlled by a specific regulation, reference the regulation and document this conclusion in Section VII.A. Additional guidance is provided in NEI 96-07 Section 4.1 and NEI 96-07 Appendix B.
If the proposed activity is controlled by multiple regulations, the Preparer may segregate the activity into separate parts and process the parts, accordingly. This approach would allow those parts controlled by specific regulations to be controlled by those specific regulations, while the parts controlled via 50.59 or 72.48 would be reviewed under 50.59 or 72.48. If taking this approach, clearly document in Section VII.A which part(s) is being dispositioned by this criterion and which part(s) is not.
Managerial and administrative procedures, which govern the conduct of facility operations and do not contain information on how SSCs are operated or controlled, are not subject to 10 CFR 50.59 review.
These procedures are instead controlled under 10 CFR 50 Appendix B (quality assurance) programs and licensee procedures (Ref: NEI 96-07, Sections 3.11 and 4.1.4). Likewise, managerial and administrative procedures that govern the conduct of dry fuel storage operations, and do not contain information on how dry fuel storage SSCs are operated or controlled, are controlled under 10 CFR 72, Subpart G (quality assurance) programs and are not subject to 10 CFR 72.48 review (Ref: NEI 96-07 Appendix B, Sections B3.11 and B4.1.4).
Procedures for maintenance activities involving the facility are controlled under 10 CFR 50 Appendix B and licensee procedures, and are not subject to review under 10 CFR 50.59 (Ref: NEI 96-07, Section 4.1.2). Maintenance activities are activities that restore SSCs to their as-designed condition, and include activities such as troubleshooting, calibration, refurbishment, post maintenance testing, post modification testing, surveillance testing, identical replacements, housekeeping, and similar activities that do not permanently alter the design, performance requirements, operation or control of SSCs. Procedures for maintenance activities involving dry fuel storage systems are controlled under 10 CFR 72.48 (Ref: NEI 96-07, Appendix B, Section B4.1.2).
IF the entire proposed activity can be dispositioned by the criteria in Section V, THEN proceed to Section VII and provide basis for conclusion in Section VII.A.
Otherwise, continue to Section VI to perform a 50.59 and/or 72.48 Screening, or perform a 50.59 and/or 72.48 Evaluation in accordance with EN-LI-101 and/or EN-LI-112.
Changes to the IPEC Unit 1 Decommissioning Plan are to be evaluated in accordance with the 50.59 process, as allowed by the NRC in a letter to IPEC dated January 31, 1996. [IPEC-1 Letter RA960014]
Beyond Design Basis - NEI 96-07 states, Emergency Operating Procedures (EOPs) include operator actions associated with response to design basis events, which are described in the FSAR, but also address operator actions for scenarios that are outside the design basis and which may not be described in the FSAR. The [50.59] Rule requires an evaluation under 50.59 only for those procedures or portions of procedures in which the operator actions are described in the FSAR. (This guidance can also be applied to proposed activities being reviewed for 72.48 applicability.) Therefore, changes that are being made to procedures or portions of procedures that are beyond design basis only require a PAD Review to document the LBD review, but will not result in a 50.59 or 72.48 Screening since it is beyond the UFSAR/CFSAR design basis.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 40 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 15 of 20 VI. 50.59 / 72.48 SCREENING REVIEW General Guidance on 50.59 / 72.48 Screening Reviews:
- 1. If it can be determined that a 50.59 Evaluation or 72.48 Evaluation is required for an activity without performing a 50.59 Screening or 72.48 Screening, then a 50.59 Evaluation or 72.48 Evaluation may be performed for the activity without performing a 50.59 Screening or 72.48 Screening.
- 2. Detailed guidance on performing 50.59/72.48 Screening Reviews is provided in Section 4.2 of NEI 96-07, Guidelines for 10 CFR 50.59 Implementation and the accompanying NEI 96-07 Appendix B, Guidelines for 10 CFR 72.48 Implementation.
- 3. A change may affect one or more design functions. An effect on any one of multiple design functions would result in the requirement to evaluate the change in accordance with 50.59 and/or 72.48.
- 4. Complicated or large changes should be broken down into manageable parts or sections before performing a PAD Review. Attempting to perform a 50.59/72.48 Screening Review on such a change may prove to be an insurmountable task, resulting in expending an inordinate amount of time and resources to determine and justify the conclusion. By breaking down the change into manageable parts, the Preparer may more efficiently perform the review. There is no prohibition on performing multiple reviews for one change. In fact, this approach may result in Screening Reviews and 50.59/72.48 Evaluations being performed for one modification. Experience has shown that if the change had been broken down into manageable parts, the associated reviews would have been of higher quality and more effectively explained when reviewed by a third-party reviewer.
- 5. Whether a 50.59/72.48 Evaluation is required depends on whether the change adversely affects a UFSAR/CFSAR-described design function as described in Section 4.2 of NEI 96-07. To determine whether or not a proposed activity adversely affects a design function, method of performing or controlling a design function, or an evaluation that demonstrates that design functions will be accomplished, a thorough understanding of the affected SSCs and the proposed activity is essential.
A given activity may have both direct and indirect effects that the Preparer must consider. Modifying or operating an SSC in a manner that it was not originally designed to perform, would be considered an adverse change. Changes to methods of evaluation require review in a 50.59/72.48 Evaluation if the methods are used either in UFSAR/CFSAR safety analyses or in establishing the design bases, and only if the methods are described, outlined, or summarized in the UFSAR/CFSAR.
- 6. The Screening Review process is not concerned with the magnitude of adverse effects that are identified. Any change that adversely affects, as described in Section 4.2 of NEI 96-07, a UFSAR/CFSAR-described design function, method of performing or controlling design functions, or evaluation that demonstrates that intended design functions will be accomplished no matter how small requires a 50.59/72.48 Evaluation. The magnitude of the adverse effect (e.g., is the minimal increase standard met?) is the focus of the 50.59/72.48 Evaluation.
- 7. A change to a design basis limit for a fission product barrier requires review in a 50.59/72.48 Evaluation.
- 8. Compare the proposed activity to the relevant portions of the UFSAR and answer the following questions:
- Does the proposed activity involve Safety Analyses or an SSC(s) credited in the Safety Analyses?
Sheet 16 of 20
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 41 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS
- Does the proposed activity involve SSCs whose failure could initiate a transient (eg, scram, loss of feedwater, etc) or accident, or whose failure could impact SSC(s) credited in the Safety Analyses?
- Does the proposed activity involve UFSAR-described SSCs or procedural controls that perform functions that are required by, or otherwise necessary to comply with, regulations, license conditions, orders or technical specifications?
- Does the proposed activity involve a method of evaluation described in the UFSAR?
- Does the proposed activity exceed or potentially affect a design basis limit for a fission product barrier (DBLFPB)?
- Does the activity adversely affect the design function(s) that were identified in above?
- Does the activity substitute a manual action for an automatic action for performing an FSAR-described design function?
- 9. Detailed guidance on performing 50.59 Screening Reviews of digital upgrades is provided in NEI 01-01, Guideline on Licensing Digital Upgrades.
Additional guidance is provided in NEI 96-07.
The term screened in means that a 50.59 or a 72.48 Evaluation is needed. The term screened out means that there is clear basis for no adverse effect on a UFSAR/CFSAR-described design function and no 50.59 or 72.48 Evaluation is required.
Tests and experiments require a 50.59 and/or 72.48 Evaluation only when such activities require that components, systems, or groups of systems be operated in modes for which they were not previously analyzed.
A test / experiment that could require a 50.59 Evaluation or 72.48 Evaluation include:
- A test not conducted in accordance with previously approved procedure
- A test that introduce substances not normally used or in quantities substantially greater than normally used
- A test that defeats protective actions or interlocks
- A test conducted in a different operating mode than covered by approved procedures A test / experiment that will likely not require a 50.59 Evaluation or 72.48 Evaluation includes:
- A test using previously approved procedures
- A test on equipment declared inoperable and isolated from operable equipment
- A passive test using installed instruments just to collect data
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 42 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 17 of 20 VI.A 50.59/72.48 SCREENING (Check the appropriate boxes.)
10 CFR 50.59 Screening criteria are met. [10 CFR 50.59(c)(1)]
The proposed activity meets all of the following criteria regarding design function:
- Does not adversely affect a method of performing or controlling a design function of an SSC as described in the UFSAR; AND
- Does not adversely affect a method of evaluation that demonstrates intended design function(s) of an SSC will be accomplished as described in the UFSAR; AND
- Does not involve a test or experiment not described in the UFSAR.
The proposed activity does not involve structures, systems, or components controlled by 10 CFR 50.59.
10 CFR 72.48 Screening criteria are met. [10 CFR 72.48(c)(1)] (Applicable to sites with an ISFSI)
The proposed activity meets all of the following criteria regarding design function:
- Does not adversely affect a method of performing or controlling a design function of an SSC as described in the CFSAR; AND
- Does not adversely affect a method of evaluation that demonstrates intended design function(s) of an SSC will be accomplished as described in the CFSAR; AND
- Does not involve a test or experiment not described in the CFSAR.
The proposed activity does not involve structures, systems, or components controlled by 10 CFR 72.48.
IF either of the 50.59 or 72.48 Screening criteria are met, THEN complete VI.B below as appropriate and proceed to Section VII.
IF the proposed activity does not meet the applicable criteria, THEN perform a 50.59 or 72.48 Evaluation in accordance with EN-LI-101 or EN-LI-112, as appropriate, attach a copy of the Evaluation to this form, and proceed to Section VII.
IF the activity does not involve systems, structures, or components controlled by 10 CFR 50.59 or by 10 CFR 72.48, THEN a 50.59 or 72.48 Screening is not required, as appropriate, and proceed to Section VII.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 43 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 18 of 20 VI.B BASIS Provide a clear, concise basis for determining the proposed activity may be screened out such that a third-party reviewer can reach the same conclusions. Refer to NEI 96-07 Section 4.2 for guidance.
Provide supporting documentation or references as appropriate.
Detailed guidance on performing 50.59/72.48 Screening Reviews is provided in Section 4.2 of NEI 96-07, Guidelines for 10 CFR 50.59 Implementation, and the accompanying NEI 96-07 Appendix B, Guidelines for 10 CFR 72.48 Implementation.
Specify the design function described in the UFSAR/CFSAR. Specify whether the change presents and adverse impact or potential adverse impact on the design function (explicitly or implicitly). Discussion should also be included to address the impact on both the "method of performing or controlling a design function" and the "method of evaluation of a design function."
With regard to methods of evaluation, if any of the following can be answered YES, then a 10 CFR 50.59 Evaluation is required: If all responses are NO, a basis for this conclusion should be documented.
- Does the activity adversely affect the method of performing or controlling design function(s) described in the UFSAR?
- Does the activity use a revised or different method of evaluation for performing safety analyses than that described in the UFSAR?
- Does the activity use a revised or different method of evaluation for evaluating SSCs credited in safety analyses than that described in the UFSAR?
VII. REGULATORY REVIEW
SUMMARY
VII.A GENERAL REVIEW COMMENTS (Provide pertinent review details and basis for conclusions if not addressed elsewhere in form.)
Because the PAD must remain essentially a stand-alone document, it is not permissible to simply reference other documents. The preparer is to provide sufficient information to allow an independent reviewer to understand the effect of the change on the licensing basis. References should be made to other calculations, evaluations, modifications or other documents which provide additional review information or justification for acceptability of the change.
If the FSAR or other LBD is being revised, this section should briefly discuss how the LBD is being affected. If there is no effect, then the discussion should clearly discuss that the electronic search and manual review did not identify any effect based on the scope of the proposed activity (i.e., below the level of detail) or the subject matter is not changed.
The Preparer should consider discussing the information contained in the pertinent sections of the LBDs to demonstrate that the proposed activity does not implicitly or explicitly affect them.
Other personnel providing input to complete the PAD Review or performing additional reviews of the PAD may be identified in this section.
If a procedure is being excluded via Process Applicability Exclusion, document the basis for the exclusion by specifically stating how the exclusion criteria are met. In addition, identify any special limitations or criteria that must be met in order for the exclusion to remain valid.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 44 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 19 of 20 VII.B CONCLUSIONS The Preparer documents the conclusions of the PAD in this section.
- 1. Is a change to an LBD being initiated? Yes IF Yes, THEN enter the appropriate change control process and include this No form with the change package.
- 2. Is a 10 CFR 50.59 Evaluation required? Yes IF Yes, THEN complete a 50.59 Evaluation in accordance with EN-LI-101 and No attach a copy to the change activity.
- 3. Is a 10 CFR 72.48 Evaluation required? Yes IF Yes, THEN complete a 72.48 Evaluation in accordance with EN-LI-112 and No attach a copy to the change activity.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 45 OF 47 Process Applicability Determination ATTACHMENT 9.2 PAD FORM INSTRUCTIONS Sheet 20 of 20 VIII. SIGNATURES 1 Preparer:
Name (print) / Signature / Company / Department / Date The Preparer must be qualified in accordance with EN-LI-100. The printed name company, department, and date must be included on the form. The signature may reference an electronic process in accordance with Note 1 below.
Reviewer:
Name (print) / Signature / Company / Department / Date The Reviewer must be qualified in accordance with EN-LI-100. The printed name, company, department, and date must be included on the form. The signature may reference an electronic process in accordance with Note 1 below.
When signing as Reviewer, your signature represents that you have read the conclusions and the discussions are complete in all respects for the related criteria. In addition, the Reviewer concurs that the activity has been properly assessed in accordance with EN-LI-100. As a minimum, the Reviewer should ensure the PAD provides adequate justification for the stated conclusions.
Process Applicability Exclusion Site Procedure Champion or Name (print) / Signature / Company / Department / Date Owner:
As a Site Procedure Champion (NMM Procedures) or Site Procedure Owner (site procedures), you are concluding that the procedure meets the Process Applicability Exclusion criteria in Section 5.4 A proper conclusion is important in that compliance with the Code of Federal Regulations could be effected. If you are uncertain of the conclusion, you are responsible for understanding the scope of the proposed exclusion and, if necessary, discussing it with the Preparer.
The appropriate designation is to be made on the Procedure Change Forms per EN-AD-101 or the site procedure change processes once the procedure has been excluded via Process Applicability Exclusion. A copy of the completed PAD for the Process Applicability Exclusion should be provided to the sites records department with the procedure change package per EN-AD-101.
Upon completion, forward this PAD form to the appropriate organization for record storage. If the PAD form is part of a process that requires transmittal of documentation, including PAD forms, for record storage, then the PAD form need not be forwarded separately.
1 Signatures may be obtained via electronic processes (e.g., PCRS, ER processes, Asset Suite signature), manual methods (e.g., ink signature), e-mail, or telecommunication. If using an e-mail , attach it to this form.
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 46 OF 47 Process Applicability Determination ATTACHMENT 9.3 PAD PROCESS FLOWCHART Sheet 1 of 2 I
PROPOSED ACTIVITY NO PAD REVIEW (SEE YES PAD EN-AD-101 OR PROCEDURE NO REQUIRED? SITE CHANGE? (5.2.4) PROCEDURE PROCESS)
NO YES NO PAD YES REVIEW LBD CHANGE (PREPARE EDITORIAL? LBDCR PER EN-LI-113)
NO II DOCUMENT REVIEW PROCESS, KEYWORDS USED, AND SUPPORTING INFO III PROCESS AFFECTED OR CONTACT YES POTENTIALLY PROCESS AFFECTED? OWNER FOR CHANGE ACCEPTABILITY NO IV LBD YES AFFECTED OR INITIATE POTENTIALLY LBDCR IF AFFECTED? APPLICABLE NO IV YES CONTACT OL, TS, CoC, LICENSING DEPT FOR ETC. AFFECTED? NRC NO GO TO NEXT PAGE GO TO NEXT PAGE
QUALITY RELATED EN-LI-100 REV. 12 NUCLEAR MANAGEMENT MANUAL INFORMATIONAL USE PAGE 47 OF 47 Process Applicability Determination ATTACHMENT 9.3 PAD PROCESS FLOWCHART Sheet 2 of 2 FROM PREVIOUS PAGE FROM PREVIOUS PAGE V.
NRC APPROVED OR YES 50.59/72.48 EVAL CONDUCTED OR CONTROLLED BY OTHER REGULATION?
NO VI.
PERFORM 50.59/72.48 SCREENING REVIEW VI.A ADVERSE ADVERSE DESIGN YES PERFORM 50.59 EVAL DESIGN FUNCTION &/OR 72.48 EVAL PER EN-FUNCTION EFFECT? LI-101 OR EN-LI-112 AFFECT?
NO VI.B DOCUMENT BASIS FOR NO ADVERSE DESIGN FUNCTION EFFECT VII.A DOCUMENT BASIS FOR CONCLUSIONS VIII.
PREPARER AND REVIEWER SIGN PAD FORM