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NRR E-mail Capture - (External_Sender) NEI 96-07, Appendix D Draft Rev. 0f July 2018
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Site:	Nuclear Energy Institute
Issue date:	07/17/2018
From:	Austgen K; Nuclear Energy Institute
To:	Chernoff H, Tekia Govan; Division of Inspection and Regional Support
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	NEI-96-07
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NRR-DMPSPEm Resource From: AUSTGEN, Kati <kra@nei.org>

Sent: Tuesday, July 17, 2018 9:36 AM To: Chernoff, Harold; Govan, Tekia; Holonich, Joseph

Subject:

[External_Sender] RE: NEI 96-07, Appendix D Draft Rev. 0f Attachments: NEI 96-07 Appendix D Rev 0f July 2018.docx; NEI 96-07 Appendix D Rev 0f July 2018 RED LINE [20180716].docx Harold & Tekia (& Joe!),

There was a typo in my e-mail from last night. It should have stated that A version with changes tracked from Rev. 0e to Rev. 0f is also attached for the convenience of reviewers. I also should have included Joe Holonich on the e-mail. Sorry for that oversight and any confusion the typo may have caused. Ill let you handle distribution to the rest of the NRC team.

Thank you, Kati Austgen l Sr. Project Manager, New Plant, SMR & Advanced Reactors 1201 F Street, NW, Suite 1100 l Washington, DC 20004 P: 202.739.8068 M: 202.340.1224 nei.org From: AUSTGEN, Kati Sent: Monday, July 16, 2018 5:25 PM To: Chernoff, Harold; Govan, Tekia (Tekia.Govan@nrc.gov)

Cc: HANSON, Jerud; Neil Archambo; David Ramendick (djrconsulting@cableone.net)

Subject:

NEI 96-07, Appendix D Draft Rev. 0f Harold & Tekia, Per NEIs action from the June 26th public meeting, please find draft Rev. 0f of NEI 96-07, Appendix D attached. This merges Section 4.3.6 back in to create a single document and incorporates edits, as appropriate, due to the issuance of the RIS 2002-22 Supplement 1.

A version with changes tracked from Rev. 0d to Rev. 0f is also attached for the convenience of reviewers.

Please let me know if you have any questions.

Kati Austgen l Sr. Project Manager, New Plant, SMR & Advanced Reactors 1201 F Street, NW, Suite 1100 l Washington, DC 20004 P: 202.739.8068 M: 202.340.1224 nei.org This electronic message transmission contains information from the Nuclear Energy Institute, Inc. The information is intended solely for the use of the addressee and its use by any other person is not authorized. If you are not the intended recipient, you have received this communication in error, and any review, use, disclosure, copying or distribution of the contents of this communication is strictly prohibited. If you have received this electronic transmission in error, please notify the sender immediately by telephone or by electronic mail and permanently delete the original message. IRS Circular 230 disclosure: To ensure compliance with requirements imposed by the IRS and other taxing authorities, we inform you that any tax advice contained in this communication (including any attachments) is not intended or written to be used, and cannot be used, for the purpose of (i) avoiding penalties that may be imposed on any taxpayer or (ii) promoting, marketing or recommending to another party any transaction or matter addressed herein.

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[External_Sender] RE: NEI 96-07, Appendix D Draft Rev. 0f Sent Date: 7/17/2018 9:35:59 AM Received Date: 7/17/2018 9:36:14 AM From: AUSTGEN, Kati Created By: kra@nei.org Recipients:

"Chernoff, Harold" <Harold.Chernoff@nrc.gov>

Tracking Status: None "Govan, Tekia" <Tekia.Govan@nrc.gov>

Tracking Status: None "Holonich, Joseph" <Joseph.Holonich@nrc.gov>

Tracking Status: None Post Office: MBX023-E2-VA-2.EXCH023.DOMAIN.LOCAL Files Size Date & Time MESSAGE 2732 7/17/2018 9:36:14 AM NEI 96-07 Appendix D Rev 0f July 2018.docx 174101 NEI 96-07 Appendix D Rev 0f July 2018 RED LINE [20180716].docx 188190 Options Priority: Standard Return Notification: No Reply Requested: No Sensitivity: Normal Expiration Date:

Recipients Received:

NEI 96-07, Appendix D Draft Revision 0f Nuclear Energy Institute SUPPLEMENTAL GUIDANCE FOR APPLICATION OF 10 CFR 50.59 TO DIGITAL MODIFICATIONS July 2018

ACKNOWLEDGMENTS NEI would like to thank the NEI 01-01 Focus Team for developing this document.

Although everyone contributed to the development of this document, NEI would like to give special recognition to David Ramendick, who was instrumental in preparing this document.

NOTICE Neither NEI, nor any of its employees, members, supporting organizations, contractors, or consultants make any warranty, expressed or implied, or assume any legal responsibility for the accuracy or completeness of, or assume any liability for damages resulting from any use of, any information apparatus, methods, or process disclosed in this report or that such may not infringe privately owned rights.

EXECUTIVE

SUMMARY

NEI 96-07, Appendix D, Supplemental Guidance for Application of 10 CFR 50.59 to Digital Modifications, provides focused application of the 10 CFR 50.59 guidance contained in NEI 96-07, Revision 1, to activities involving digital modifications.

The main objective of this guidance is to provide all stakeholders a common framework and understanding of how to apply the 10 CFR 50.59 process to activities involving digital modifications.

The guidance in this appendix supersedes the 10 CFR 50.59-related guidance contained in NEI 01-01/ EPRI TR-102348, Guideline on Licensing of Digital Upgrades.

i

TABLE OF CONTENTS EXECUTIVE

SUMMARY

...................................................................................................................................... i 1 INTRODUCTION ........................................................................................................................................ 2

1.1 BACKGROUND

................................................................................................... 2 1.2 PURPOSE ........................................................................................................... 3 1.3 10 CFR 50.59 PROCESS

SUMMARY

.................................................................. 3 1.4 APPLICABILITY TO 10 CFR 72.48 ................................................................... 3 1.5 CONTENT OF THIS GUIDANCE DOCUMENT ..................................................... 3 2 DEFENSE IN DEPTH DESIGN PHILOSOPHY AND 10 CFR 50.59 ................................................ 3 3 DEFINITIONS AND APPLICABILITY OF TERMS ............................................................................... 4 4 IMPLEMENTATION GUIDANCE............................................................................................................. 5 4.1 APPLICABILITY ................................................................................................. 5 4.2 SCREENING ....................................................................................................... 5 4.3 EVALUATION PROCESS ................................................................................... 23 5.0 EXAMPLES ............................................................................................................................................... 60 D-1

1 INTRODUCTION There are specific considerations that should be addressed as part of the 10 CFR 50.59 process when performing 10 CFR 50.59 reviews for digital modifications. These specific considerations include different potential failure modes of digital equipment as opposed to the equipment being replaced, the effect of combining functions of previously separate devices (at the component level, at the system level, or at the "multi-system" level) into fewer devices or one device, and the potential for software common cause failure (software CCF ).

The format of this Appendix was aligned with NEI 96-07, Rev. 1 text for ease of use. As such, there will be sections where no additional guidance is provided.

1.1 BACKGROUND

Licensees have a need to modify existing systems and components due to the growing problems of obsolescence, difficulty in obtaining replacement parts, and increased maintenance costs. There also is great incentive to take advantage of modern digital technologies which offer potential performance and reliability improvements.

In 2002, a joint effort between the Electric Power Research Institute (EPRI) and the Nuclear Energy Institute (NEI) produced NEI 01-01, Revision 0 (also known as EPRI TR-102348, Revision 1), Guideline on Licensing Digital Upgrades: A Revision of EPRI TR-102348 to Reflect Changes to the 10 CFR 50.59 Rule, which was endorsed (with qualifications) by the Nuclear Regulatory Commission (NRC) in Regulatory Issue Summary (RIS) 2002-22.

Since the issuance of NEI 01-01 in 2002, digital modifications have become more prevalent. Application of the 10 CFR 50.59 guidance contained in NEI 01-01 has not been consistent or thorough across the industry, leading to NRC concern regarding uncertainty as to the effectiveness of NEI 01-01 and the need for clarity to ensure an appropriate level of rigor is being applied to a wide variety of activities involving digital modifications.

NEI 01-01 contained guidance for both the technical development and design of digital modifications as well as the application of 10 CFR 50.59 to those digital modifications. The NRC also identified this as an issue and stated that NEI could separate technical guidance from 10 CFR 50.59 related guidance.

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1.2 PURPOSE Appendix D is intended to assist licensees in the performance of 10 CFR 50.59 reviews of activities involving digital modifications in a consistent and comprehensive manner. This assistance includes guidance for performing 10 CFR 50.59 Screens and 10 CFR 50.59 Evaluations. This appendix does not include guidance regarding design requirements for digital activities.

The guidance in this appendix applies to 10 CFR 50.59 reviews for both small-scale and large-scale digital modifications; from the simple replacement of an individual analog meter with a microprocessor-based instrument, to a complete replacement of an analog reactor protection system with an integrated digital system. Examples of activities considered to be a digital modification include computers, computer programs, data (and its presentation), embedded digital devices, software, firmware, hardware, the human-system interface, microprocessors and programmable digital devices (e.g., Programmable Logic Controllers and Field Programmable Gate Arrays).

This guidance is not limited to "stand-alone" instrumentation and control systems. This guidance can also be applied to the digital aspects of modifications or replacements of mechanical or electrical equipment if the new equipment makes use of digital technology (e.g., a new HVAC design that includes embedded microprocessors for control).

Finally, this guidance is applicable to digital modifications involving safety-related and non-safety-related systems and components and also covers digital-to-digital activities (i.e., modifications or replacements of digital-based systems).

1.3 10 CFR 50.59 PROCESS

SUMMARY

No additional guidance is provided.

1.4 APPLICABILITY TO 10 CFR 72.48 No additional guidance is provided.

1.5 CONTENT OF THIS GUIDANCE DOCUMENT No additional guidance is provided.

2 DEFENSE IN DEPTH DESIGN PHILOSOPHY AND 10 CFR 50.59 No additional guidance is provided.

D-3

3 DEFINITIONS AND APPLICABILITY OF TERMS Definitions 3.1 through 3.14 are the same as those provided in NEI 96-07, Rev. 1. Definitions specific to this appendix are defined below.

3.15 Sufficiently Low Sufficiently low means much lower than the likelihood of failures that are considered in the UFSAR (e.g., single failures) and comparable to other common cause failures that are not considered in the UFSAR (e.g., design flaws, maintenance errors, and calibration errors).

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4 IMPLEMENTATION GUIDANCE 4.1 APPLICABILITY No additional guidance is provided.

4.2 SCREENING CAUTION The guidance contained in this appendix is intended to supplement the generic Screen guidance contained in the main body in NEI 96-07, Section 4.2.

Namely, the generic Screen guidance provided in the main body of NEI 96-07 and the more-focused Screen guidance in this appendix BOTH apply to digital modifications.

Introduction Throughout this section, references to the main body of NEI 96-07, Rev. 1 will be identified as "NEI 96-07."

As stated in NEI 96-07, Section 4.2.1, the determination of the impact of a proposed activity (i.e., adverse or not adverse) is based on the impact of the proposed activity on UFSAR-described design functions. To assist in determining the impact of a digital modification on a UFSAR-described design function, the general guidance from NEI 96-07 will be supplemented with the digital-specific guidance in the topic areas identified below.

Digital-to-Digital Replacements and "Equivalency" In NEI 96-07, Section 4.2.1.1, equivalent replacements are discussed.

However, digital-to-digital changes may not necessarily be equivalent because the component/system behaviors, response time, failure modes, etc.

for the new component/system may be different from the old component/system. All non-equivalent digital-to-digital replacements should utilize the guidance provided in this Appendix.

Guidance Focus In the following sections and sub-sections that provide the Screen guidance unique to the application of 10 CFR 50.59 to digital modifications, each section and sub-section addresses only a specific aspect, sometimes at the deliberate exclusion of other related aspects.

This focused approach is intended to concentrate on the particular aspect of interest and does not imply that the other aspects do not apply or could not D-5

be related to the aspect being addressed. Initially, all aspects need to be considered, with the knowledge that some of them may be able to be excluded based on the actual scope of the digital modification being reviewed.

Example Focus Within this appendix, examples are provided to illustrate the guidance.

Unless stated otherwise, a given example only addresses the aspect or topic within the section/sub-section in which it is included, sometimes at the deliberate exclusion of other aspects or topics which, if considered, could potentially change the Screen conclusion.

Human-System Interface Evaluations Similar to other technical evaluations (performed as part of the design modification package), a human factors engineering (HFE) evaluation determines the impacts and outcomes of the change (e.g., personnel acts or omissions, as well as their likelihoods and effects). The licensing-based reviews (Screens and Evaluations) performed in accordance with 10 CFR 50.59 compare the impacts and new outcomes (i.e., post-modification) to the initial conditions and current outcomes (i.e., pre-modification) in order to determine the effect on design functions (in the Screen phase) and the need for a license amendment request (in the Evaluation phase).

4.2.1 Is the Activity a Change to the Facility or Procedures as Described in the UFSAR?

Introduction A 10 CFR 50.59 Evaluation is required for digital modifications that adversely affect design functions, or the methods used to perform or control design functions. There is no regulatory requirement for a proposed activity involving a digital modification to default (i.e., be mandatorily "forced") to an adverse conclusion.

Although there may be adverse impacts on UFSAR-described design functions due to the following types of activities involving a digital modification, these typical activities do not default to an adverse conclusion simply because of the activities themselves.

The introduction of software or digital devices.

The replacement of software and/or digital devices with other software and/or digital devices.

The use of a digital processor to "calculate" a numerical value or "generate" a control signal using software in place of using analog components.

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Replacement of hard controls (i.e., pushbuttons, knobs, switches, etc.) with a touch-screen to operate or control plant equipment.

Engineering/technical information should be documented (as part of the design process) to record the impacts from digital modifications. This engineering/technical information will be used as the basis/justification for the conclusion of adverse or not adverse.

Scope of Digital Modifications Generally, a digital modification may consist of three areas of activities: (1) software-related activities, (2) hardware-related activities and (3) Human-System Interface-related activities.

NEI 96-07, Section 4.2.1.1 provides guidance for activities that involve "...an SSC design function..." or a "...method of performing or controlling a design function..." and Section 4.2.1.2 provides guidance for activities that involve

"...how SSC design functions are performed or controlled (including changes to UFSAR-described procedures, assumed operator actions and response times)."

Based on this segmentation of activities, the software and hardware portions will be assessed within the "facility" Screen consideration since these aspects involve SSCs, SSC design functions, or the method of performing or controlling a design function and the Human-System Interface portion will be assessed within the "procedures" Screen consideration since this portion involves how SSCs are operated and controlled.

4.2.1.1 Screening of Changes to the Facility as Described in the UFSAR SCOPE In the determination of potential adverse impacts, the following aspects should be addressed in the response to this Screen consideration:

(a) Use of Software and Digital Devices (b) Combination of Components/Systems and/or Functions USE OF SOFTWARE AND DIGITAL DEVICES In NEI 96-07, Section 4.2.1, sub-section titled "Screening for Adverse Effects,"

the second paragraph contains the following guidance:

"...changes that would introduce a new type of accident or malfunction would screen in." [emphasis added]

Note that this Screen guidance does NOT address the "result(s)" of a new malfunction, which is the subject of Evaluation criterion (c)(2)(vi).

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For applications involving SSCs with design functions, digital modifications that introduce the exact same software into redundant trains or channels to perform a design function have the potential to create a new malfunction.

The potential to create a new malfunction comes from the possibility of a software CCF that did not previously exist.

For relatively simple digital modifications, engineering evaluations may be used to show that the digital modification would not adversely affect design functions; even for digital modifications that involve redundant components/systems because the reliability of performing design functions is not decreased and no new malfunctions are created.

To reach a screen conclusion of not adverse for relatively simple digital modifications, the degree of assurance needed to make that conclusion is based on considerations such as the following:

Physical Characteristics of the Digital Modification The change has a limited scope (e.g., replace analog transmitter with a digital transmitter that drives an existing instrument loop)

Uses a relatively simple digital architecture internally (simple process of acquiring one input signal, setting one output, and performing some simple diagnostic checks)

Has limited functionality (e.g., transmitters used to drive signals for parameters monitored)

Can be comprehensively tested (but not necessarily 100 percent of all combinations)

Engineering Evaluation Assessments The quality of the design processes employed Single failures of the digital device are encompassed by existing failures of the analog device (e.g., no new digital communications among devices that introduce possible new failure modes involving separate devices)

Has extensive applicable operating history The use of different software in two or more channels, trains or loops of SSCs is not adverse due to a software CCF because there is no mechanism to create a new malfunction due to the introduction of software.

Some specific examples of activities that have the potential to cause an adverse effect include the following activities:

Addition or removal of a dead-band, or D-8

Replacement of instantaneous readings with time-averaged readings (or vice-versa).

In each of these specific examples, the impact on a design function associated with the stated condition needs to be assessed to determine the Screen conclusion (i.e., adverse or not adverse).

Example 4-1 illustrates the application of the guidance for a relatively simple digital modification.

Example 4-1. NO ADVERSE IMPACT on a Design Function for a Relatively Simple Digital Modification Proposed Activity Description Transmitters are used to drive signals for parameters monitored by redundant ESFAS channels. The original analog transmitters are to be replaced with microprocessor-based transmitters. The change is of limited scope since the existing 4-20 mA instrument loop is maintained for each channel without any changes other than replacing the transmitter itself.

The digital transmitters are used to drive signals of monitored parameters and thus have limited functionality with respect to the Engineered Safety Features Actuation System (ESFAS) design function.

Design Function Identification The ESFAS design function is the ability to respond to plant accidents.

Screen Response The digital transmitters use a relatively simple digital architecture internally in that the firmware in the new transmitters implements a simple process of acquiring one input signal, setting one output, and performing some simple diagnostic checks.

Failures of the new digital device are encompassed by the failures of the existing analog device in that there are no new digital communications among devices that introduce possible new failure modes involving multiple devices. The engineering evaluation of the digital device concluded that the digital system is at least as reliable as the previous system, the conclusion of which is based on the quality of the design processes employed, and the operating history of the software and hardware used. In addition, based on the simplicity of the device (one input and one output), it was comprehensively tested. Further, substantial operating history has demonstrated high reliability in applications similar to the ESFAS application.

Therefore, the proposed digital modification is not adverse because the digital modification is relatively simple and the assessment of the considerations identified above has determined that the reliability of performing the design D-9

function is not reduced and no new malfunctions are created.

Examples 4-2 and 4-3 illustrate the application of the Use of Software and Digital Devices aspect.

Example 4-2. NO ADVERSE IMPACT on a Design Function related to use of Software and Digital Devices Proposed Activity Description Two non-safety-related trains of main feedwater heaters exist, one for each train of main feedwater. Each main feedwater train consists of six feedwater heaters, for a total of 12 heaters. Each heater possesses an analog controller to control the water level in each of the heaters. Each analog controller is physically and functionally the same.

Each of the analog controllers will be replaced with its own digital controller.

The hardware platform for each digital controller is from the same supplier and the software in each digital controller is exactly the same.

Design Function Identification There are NO design functions associated with the feedwater heater water level controllers. The only UFSAR description related to the heaters states that the feedwater heater water level controllers are used to adjust the water levels in the heaters to optimize the thermal efficiency of the facility.

Screen Response Since there are no design functions associated with the feedwater heater water level controllers, there are no adverse impacts.

Example 4-3. ADVERSE IMPACT on a Design Function related to use of Software and Digital Devices Proposed Activity Description Two non-safety-related main feedwater pumps (MFWPs) exist. There are two analog control systems (one per MFWP) that are physically and functionally the same.

The two analog control systems will be replaced with two digital control systems. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

Design Function Identification D-10

The design function of the feedwater control systems is to automatically control and regulate feedwater flow to the steam generators.

The UFSAR identifies the following MFWP control system malfunctions:

(a) failures causing the loss of one MFWP and its associated flow to the steam generators, and (b) failures causing an increase in main feedwater flow to the maximum output from one MFWP.

Screen Response The digital modification associated with this proposed activity is not relatively simple, so the process for assessing relatively simple digital modifications could not be used. There is an adverse impact on the design function of the main feedwater control system because the use of the exact same software in both digital control systems creates a new malfunction that could impact both MFWPs due to a potential software CCF.

COMBINATION OF COMPONENTS/SYSTEMS AND/OR FUNCTIONS The UFSAR may identify the number of components/systems, how the components/systems were arranged, and/or how functions, i.e., design requirements, were allocated to those components/systems.

When replacing analog SSCs with digital SSCs, it is potentially advantageous to combine multiple components/systems and/or functions into a single device or control system. However, as a result of this combination, the failure of the single device or control system has the potential to adversely affect the performance of design functions.

The combination of previously separate components/systems and/or functions, in and of itself, does not make the Screen conclusion adverse. Only if combining the previously separate components/systems and/or functions causes an adverse impact on a design function does the combination aspect of the digital modification screen in.

When comparing the existing and proposed configurations, consider how the proposed configuration affects the number and/or arrangement of components/systems and the potential impacts of the proposed arrangement on design functions.

Examples 4-4 through 4-6 illustrate the application of the Combination of Components/Systems and/or Functions aspect.

Example 4-4. Combining Components and Functions with NO D-11

ADVERSE IMPACT on a Design Function Proposed Activity Description Two non-safety-related main feedwater pumps (MFWPs) exist. There are two analog control systems (one per MFWP) that are physically and functionally the same. Each analog control system has many subcomponents.

Option #1: Within each control system, all of the analog subcomponents will be replaced with a single digital device that consolidates all of the components, sub-components and the functions associated with each component and sub-component. The components in each analog control system will be replaced with a separate digital control system.

Option #2: Instead of two separate, discreet, unconnected digital control systems being used for the feedwater control systems, only one central digital device is proposed to be used that will combine the previously separate control systems and control both main feedwater pumps.

Design Function Identification Although the control systems and the major components are described in the UFSAR, only a design function for the feedwater control systems is identified.

The design function of the feedwater control systems is to automatically control and regulate feedwater flow to the steam generators.

The UFSAR identifies the following MFWP control system malfunctions:

(a) failures causing the loss of all feedwater to the steam generators, and (b) failures causing an increase in main feedwater flow to the maximum output from both MFWPs.

Screen Response NOTE: Since the intent of this example is to illustrate the combination aspect ONLY, the software and hardware aspects will not be addressed in this example.

Option #1: There is no adverse impact on the design function of the main feedwater control systems to automatically control and regulate feedwater to the steam generators due to the combination of components in each of the two channels because no new malfunctions are created (i.e., the current malfunctions already consider the effect on both MFWPs).

Option #2: Although both main feedwater pumps would be affected by the failure of the one central digital processor, the proposed activity is not adverse because no new malfunctions are created (i.e., the current malfunctions already consider the effect on both MFWPs).

NOTE: For both options, if the malfunctions had considered the effect on D-12

only one MFWP, the Screen conclusions would have been adverse because a new malfunction would have been created.

Example 4-5. Combining Components and Functions with NO ADVERSE IMPACT on a Design Function Proposed Activity Description A temperature monitor/controller in a room provides an input to an air damper controller. If temperature gets too high, the temperature controller sends a signal to the air damper to open (if closed) to a predetermined initial position or, if already open, adjusts the position of the damper to allow increased air flow into the room.

Both analog controllers will be replaced with a single digital device that will perform in accordance with the original design requirements providing both temperature monitoring/control and air damper control.

Design Function Identification The temperature monitor/controller performs a design function to continuously monitor the temperature in the room to ensure the initial conditions are met should the emergency room coolers be needed.

The air damper controller performs a design function to continuously provide the appropriate air flow to the room to ensure the initial conditions are met should the emergency room coolers be needed.

There is no lower limit on the acceptable temperature in the room.

Screen Response An engineering evaluation has documented the following malfunctions of the analog devices:

(1) failure of the temperature monitor/controller, causing the loss of input to the air damper controller and the ability of the air damper controller to control the temperature in the room, and (2) failure of the air damper controller, causing the loss of the ability to control the temperature in the room.

Also documented in the engineering evaluation is the malfunction of the digital device, causing the loss of input to the air damper controller and the ability of the air damper controller to control the temperature in the room.

A comparison of the analog component and digital device malfunctions shows them to be the same. Therefore, although using the digital device might D-13

cause multiple design functions to not be performed, no new malfunctions are created. With no new malfunctions being created, there is no adverse impact on the design functions due to the combination aspect. Also, there are no indirect impacts that could affect the performance of the design functions due to the combination aspect.

The combining of components/systems and/or functions that were previously and completely physically and/or electrically separate (i.e., not coupled) are of particular interest when determining the impact on design functions.

Example 4-6 illustrates the combining of control systems from different, originally separate systems.

Example 4-6. Combining Systems and Functions with an ADVERSE IMPACT on a Design Function Proposed Activity Description Two non-safety-related analog feedwater control systems and one separate non-safety-related main turbine steam inlet valves analog control system exist.

All three analog control systems will be replaced with one digital control system that will combine the two feedwater control systems and the main turbine steam-inlet valve control system into a single digital device.

Design Function Identification The design function of the feedwater control systems is to automatically control and regulate feedwater flow to the steam generators.

The design function of the main turbine inlet valve control system is to automatically control and regulate steam flow to the main turbine.

A review of the accident analyses identifies that none of the analyses consider the simultaneous failure of the feedwater control system and the failure of the main turbine control system.

Screen Response Because new malfunctions have been introduced, there are adverse impacts on the design function of the main feedwater control systems and the design function of the main turbine control system due to the combination of components and functions from the three control systems.

4.2.1.2 Screening of Changes to Procedures as Described in the UFSAR SCOPE D-14

If the digital modification does not include or affect a Human-System Interface (e.g., the replacement of a stand-alone analog relay with a digital relay that has no features involving personnel interaction and does not feed signals into any other analog or digital device), then this section does not apply and may be excluded from the Screen assessment.

In NEI 96-07, Section 3.11 defines procedures as follows:

"...Procedures include UFSAR descriptions of how actions related to system operation are to be performed and controls over the performance of design functions. This includes UFSAR descriptions of operator action sequencing or response times, certain descriptions...of SSC operation and operating modes, operational...controls, and similar information."

Although UFSARs do not typically describe the details of a specific Human-System Interface (HSI), UFSARs will describe any design functions associated with the HSI.

Because the HSI involves system/component operation, this portion of a digital modification is assessed in this Screen consideration. The focus of the Screen assessment is on potential adverse effects due to modifications of the interface between the human user and the technical device.

Note that the "human user" could involve Control Room Operators, other plant operators, maintenance personnel, engineering personnel, technicians, etc.

There are three "basic HSI elements" of an HSI (

Reference:

NUREG-0700):

Displays: the visual representation of the information personnel need to monitor and control the plant.

Controls: the devices through which personnel interact with the HSI and the plant.

User-interface interaction and management: the means by which personnel provide inputs to an interface, receive information from it, and manage the tasks associated with access and control of information.

Any user of the HSI must be able to accurately perceive, comprehend and respond to system information via the HSI to successfully complete their tasks. Specifically, nuclear power plant personnel perform "four generic primary tasks" (

Reference:

NUREG/CR-6947):

1. Monitoring and detection (extracting information from the environment and recognizing when something changes),

2. Situation assessment (evaluation of conditions),

3. Response planning (deciding upon actions to resolve the situation), and

4. Response implementation (performing an action).

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Table 1 contains examples of modifications to each of the three basic HSI elements applicable to this Screen consideration.

Table 1 - Example Human-System Interface Modifications Typical HSI Element Description/Example Modification Increase/decrease in the amount of information displayed by and/or available from the HSI (e.g., combining multiple parameters into a single integrated Number of Parameters parameter, adding additional information regarding component/system performance)

Change to the type of information displayed and/or available from the HSI Displays Type of Parameters (e.g., removing information that was previously available or adding information that was previously unavailable)

Change to visual representation of information (e.g. increment of presentation Information Presentation modified)

Change to structural arrangement of data/information (e.g., information now Information Organization organized by channel/train rather than by flow-path)

Change to the type/functionality of input device (e.g., replacement of a push Control Input button with a touch screen)

Controls Change to the information sent back to the individual in response to an action Control Feedback (e.g., changing feedback from tactile to auditory)

Change in number and/or type of decisions made and/or actions taken (e.g.,

replacing an analog controller that can be manipulated in one step with a Action Sequences digital controller that must be called-up on the interface and then User-Interface manipulated)

Interaction and Changes that affect how an individual retrieves information/data (e.g.,

Information/Data Management information that was continuously displayed via an analog meter now requires Acquisition interface interaction to retrieve data from a multi-purpose display panel)

Changes from manual to automatic initiation (or vice versa) of functions (e.g.,

Function Allocation manual pump actuation to automatic pump actuation)

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To determine potential adverse impacts of HSI modifications on design functions, a two-step HSI assessment must be performed, as follows:

Step One - Identify the generic primary tasks that are involved with (i.e., potentially impacted by) the proposed activity.

Step Two - For all primary tasks involved, assess if the modification negatively impacts an individual's ability to perform the generic primary task.

Examples of negative impacts on an individual's performance that may result in adverse effects on a design function include, but are not limited to:

increased possibility of mis-operation, increased difficulty in evaluating conditions, increased difficulty in performing an action, increased time to respond, and creation of new potential failure modes.

After the two-step HSI assessment, the final step is application of the standard Screen assessment process (i.e., identification of design functions and determination of adverse or not adverse, including the justification for the conclusion).

SIMPLE HUMAN-SYSTEM INTERFACE EXAMPLE Example 4-7 illustrates how a digital modification with HSI considerations would be addressed.

Example 4-7: Assessment of Modification with NO ADVERSE IMPACT on a UFSAR-Described Design Function Proposed Activity Description Currently, a knob is rotated clock-wise to open a flow control valve in 1%

increments and counter clock-wise to close a flow control valve in 1%

increments. This knob will be replaced with a touch screen that has two separate arrows, each in its own function block. Using the touch screen, touching the "up" arrow will open the flow control valve in 1% increments and touching the "down" arrow will close the flow control valve in 1%

increments.

HSI Assessment Process STEP 1. Identification of the Generic Primary Tasks Involved:

(1) Monitoring and detection (extracting information from the D-17

environment and recognizing when something changes) - NOT INVOLVED (2) Situation assessment (evaluation of conditions) - NOT INVOLVED (3) Response planning (deciding upon actions to resolve the situation) -

NOT INVOLVED (4) Response implementation (performing an action) -INVOLVED STEP 2. Assessment of Modification Impacts on the Involved Generic Primary Tasks:

As part of the technical evaluation supporting the proposed modification, a HFE evaluation was performed.

Tasks 1, 2 and 3 were not involved, so these tasks are not impacted by the modification.

Task 4 was identified as involved; the HFE evaluation determined that the change from knob to touch screen would not have a negative impact because it does not affect the operators ability to perform the response implementation task.

Identification and Assessment of the Relevant Design Function(s)

The UFSAR states the operator can "open and close the flow control valve using manual controls located in the Main Control Room." Thus, the design function is the ability to allow the operator to manually adjust the position of the flow control valve and the UFSAR description implicitly identifies the SSC (i.e., the knob).

Using the results from the HFE evaluation and examining the replacement of the "knob" with a "touch screen," the modification is not adverse because it does not impact the ability of the operator to "open and close the flow control valve using manual controls located in the Main Control Room," maintaining satisfaction of the UFSAR-described design function.

COMPREHENSIVE HUMAN-SYSTEM INTERFACE EXAMPLES Examples 4-8a and 4-8b illustrate how a digital modification with HSI considerations would be addressed.

Although both examples use the same basic digital modification, Example 4-8a illustrates a no adverse impact case and Example 4-8b illustrates an adverse impact case by "complicating" the HSI portion of the modification.

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Example 4-8a. Digital Modification Involving HSI Considerations with NO ADVERSE IMPACT on a Design Function Proposed Activity Description Analog components and controls for a redundant safety-related system are to be replaced with digital components and controls, including new digital-based HSI.

Currently, two redundant channels/trains of information and controls are provided to the operators in the Main Control Room for the redundant systems. For each channel/train, several different analog instruments present information regarding the performance of the system. The analog displays are arranged by system "flow path" to facilitate the operator's ability to monitor the system as a whole.

The existing HSI for these components is made up of redundant hard-wired switches, indicator lights and analog meters. The new HSI consolidates the information and controls onto two flat panel displays (one per train) with touch screen soft controls. The information available on the flat panels is equivalent to that provided on the current analog HSI. Each flat panel display contains only one screen that displays the information and the controls for only that train, replicating the information and controls arrangement as they are in the existing HSI.

The existing HSI requires operators to manipulate analog switches to implement a control action. To take a control action using the new HSI, the operator must (via the touch screen) select the appropriate activity (e.g.,

starting/initiating the system or changing the system line-up), select the component to be controlled (e.g., pump or valve), select the control action (e.g., start/stop or open/close), and execute the action.

HSI Assessment Process Step 1. Identification of Which Four Generic Primary Tasks are Involved:

(1) Monitoring and detection (extracting information from the environment and recognizing when something changes) - INVOLVED (2) Situation assessment (evaluation of conditions) - NOT INVOLVED (3) Response planning (deciding upon actions to resolve the situation) -

NOT INVOLVED (4) Response implementation (performing an action) - INVOLVED Step 2. Assessment of the Modification Impacts on the Involved Generic Primary Tasks:

As part of the technical evaluation supporting the proposed modification, a HFE evaluation was performed.

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Task 1 is involved. Any change to information presentation has the potential to impact the operators ability to monitor and detect changes in plant parameters. Even though the modification will result in information being presented on flat panels, the information available and the organization of that information (i.e., by train) will be equivalent to the existing HSI. Due to this equivalence and additional favorable factors (e.g., appropriate sized flat panels, appropriate display brightness, clearly identified function buttons, etc.) as documented in the HFE evaluation, there is no impact to the operators ability to monitor and detect changes in plant parameters.

Tasks 2 and 3 were not involved, so these tasks are not impacted by the modification.

Task 4 is involved. The modification will require the operator to perform four actions in order to manipulate a control (i.e., 1. select the appropriate activity, 2. select the specific component to be controlled, 3. select the control action to be initiated, and 4. execute the action). Currently, the operator is able to manipulate a control in one action (e.g., turn a switch to on/off). The HFE evaluation determined that the modification negatively impacts the operators ability to respond because the modification increases the difficulty of implementing a response by requiring four actions instead of one action and the additional actions result in an increase in the operators time to respond.

Identification and Assessment of Design Functions Design Function Identification (a) Status indications are continuously available to the operator.

(b) The operator controls the system components manually.

Screen Response Since the information available and the organization of that information using the new HSI is equivalent to the existing HSI, the design function for continuous availability of status indications is met and there is no adverse impact on design function (a).

Using the touch screen, the operator is still able to perform design function (b) to manipulate the control for the systems components. Therefore, there is no adverse impact on satisfaction of design function (b).

Example 4-8b. Digital Modification Involving HSI Considerations with an ADVERSE IMPACT on a Design Function D-20

Proposed Activity Description Analog components and controls for a redundant safety-related system are to be replaced with digital components and controls, including new digital-based HSI.

Currently, two redundant channels/trains of information and controls are provided to the operators in the Main Control Room for the redundant systems. For each channel/train, several different analog instruments present information regarding the performance of the system. The analog displays are arranged by system "flow path" to facilitate the operator's ability to monitor the system as a whole.

The existing HSI for these components is made up of redundant hard-wired switches, indicator lights and analog meters. The new HSI consolidates the information and controls onto two flat panel displays (one per train) with touch screen soft controls. The information available on the flat panels is equivalent to that provided on the current analog HSI. Each flat panel display contains only one screen, which can display the information for only one train and the controls for only that train, replicating the information and controls arrangement as they are in the existing HSI. Each flat panel display can be customized to display the parameters and/or the configuration (e.g. by train, by flow path or only portions of a train or flow path) preferred by the operators. In addition, the flat panel displays provide many other display options to the user (e.g., individual component status and component/system alarms).

The existing HSI requires operators to manipulate analog switches to implement a control action. To take a control action using the new HSI, the operator must (via the touch screen) select the appropriate activity (e.g.,

starting/initiating the system or changing the system line-up), select the component to be controlled (e.g., pump or valve), select the control action (e.g., start/stop or open/close), and execute the action.

HSI Assessment Process Step 1. Identification of Which Four Generic Primary Tasks are Involved:

(1) Monitoring and detection (extracting information from the environment and recognizing when something changes) - INVOLVED (2) Situation assessment (evaluation of conditions) - INVOLVED (3) Response planning (deciding upon actions to resolve the situation) -

INVOLVED (4) Response implementation (performing an action) - INVOLVED Step 2. Assessment of the Modification Impacts on the Involved Generic Primary Tasks:

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As part of the technical evaluation supporting the proposed modification, a HFE evaluation was performed.

Tasks 1, 2 and 3 are involved (emphasizing that the modification includes a change to information presentation and organization, such that the indications/instruments are now consolidated and presented on customizable flat panel displays, rather than static analog control boards). With the new displays and display options available to the operators, the operators can choose which parameters to display and the organization of that information (e.g., by train/path). The HFE evaluation concluded that this modification could result in the operator choosing not to have certain parameters displayed; thus negatively impacting their ability to monitor the plant and detect changes. In addition, altering the information displayed and the organization of the information will negatively impact the operators understanding of how the information relates to system performance. This negative impact on understanding will also negatively impact the operators ability to assess the situation and plan an appropriate response.

Task 4 is involved. The modification will require the operator to perform four actions in order to manipulate a control (i.e., 1. select the appropriate activity, 2. select the specific component to be controlled, 3. select the control action to be initiated, and 4. execute the action). Currently, the operator is able to manipulate a control in one action (e.g., turn a switch to on/off). The HFE evaluation determined that the modification negatively impacts the operators ability to respond because the modification increases the difficulty of implementing a response by requiring four actions instead of one action and the additional actions result in an increase in the operators time to respond.

Identification and Assessment of Design Functions Design Function Identification (a) Status indications are continuously available to the operator.

(b) The operator controls the system components manually.

Screen Response The information available and the organization of that information in the new displays are customizable based on operator preference. Critical status indications may not be continuously available to the operator, thus there is an adverse impact on design function (a).

Using the touch screen, the operator is still able to perform design function (b) to manipulate the control for the systems components. Therefore, there is no adverse impact on satisfaction of design function (b).

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Since there is an adverse impact on design function (a), the overall conclusion of the Screen for this consideration would be adverse.

4.2.1.3 Screening Changes to UFSAR Methods of Evaluation By definition, a proposed activity involving a digital modification involves SSCs and how SSCs are operated and controlled, not a method of evaluation described in the UFSAR (see NEI 96-07, Section 3.10).

Methods of evaluation are analytical or numerical computer models used to determine and/or justify conclusions in the UFSAR (e.g., accident analyses that demonstrate the ability to safely shut down the reactor or prevent/limit radiological releases). These models also use "software." However, the software used in these models is separate and distinct from the software installed in the facility. The response to this Screen consideration should reflect this distinction.

A necessary revision or replacement of a method of evaluation (see NEI 96-07, Section 3.10) resulting from a digital modification is separate from the digital modification itself and the guidance in NEI 96-07, Section 4.2.1.3 applies.

4.2.2 Is the Activity a Test or Experiment Not Described in the UFSAR?

By definition, a proposed activity involving a digital modification involves SSCs and how SSCs are operated and controlled, not a test or experiment (see NEI 96-07, Section 4.2.2). The response to this Screen consideration should reflect this characterization.

A necessary test or experiment (see NEI 96-07, Section 3.14) involving a digital modification is separate from the digital modification itself and the guidance in NEI 96-07, Section 4.2.2 applies.

4.3 EVALUATION PROCESS CAUTION The guidance contained in this appendix is intended to supplement the generic Evaluation guidance contained in the main body in NEI 96-07, Section 4.3.

Namely, the generic Evaluation guidance provided in the main body of NEI 96-07 and the more-focused Evaluation guidance in this appendix BOTH apply to digital modifications.

Introduction D-23

Throughout this section, references to the main body of NEI 96-07, Rev. 1 will be identified as "NEI 96-07."

Guidance Focus In the following sections and sub-sections that describe the Evaluation guidance particularly useful for the application of 10 CFR 50.59 to digital modifications, each section and sub-section describes only a specific aspect, sometimes at the deliberate exclusion of other related aspects. This focused approach is intended to concentrate on the particular aspect of interest and does not imply that the other aspects do not apply or could not be related to the aspect being addressed.

Example Focus Examples are provided to illustrate the guidance provided herein. Unless stated otherwise, a given example only addresses the specific aspect or topic within the section/sub-section in which it is included, sometimes at the deliberate exclusion of other aspects or topics that, if considered, could potentially change the Evaluation conclusion.

Qualitative Assessment For digital I&C systems, reasonable assurance of low likelihood of failure is derived from a qualitative assessment of factors involving the design attributes of the modified SSC, the quality of the design processes, and the operating experience of the software and hardware used (i.e., product maturity and in-service experience). The qualitative assessment is used to record the factors and rationale and reasoning for making a determination that there is reasonable assurance that the digital I&C modification will exhibit a low likelihood of failure by considering the aggregate of these factors.

SSC Failure Likelihood Determination Outcomes The possible outcomes of an engineering evaluation (e.g., qualitative assessment), performed in accordance with applicable Industry and/or NRC guidance documents, are as follows:

(1) SSC failure likelihood is sufficiently low (as defined in Definition 3.15), or (2) SSC failure likelihood is not sufficiently low.

If the SSC failure likelihood is determined to be sufficiently low, then by extension, the likelihood of software CCF is also considered to be sufficiently low.

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If the failure likelihood of the modified SSC is not examined as part of an engineering evaluation, then the failure likelihood of the modified SSC will be assumed to be not sufficiently low for purposes of responding to the following 10 CFR 50.59 Evaluation criteria.

These possible outcomes (i.e., sufficiently low or not sufficiently low) will be used in developing the responses to Evaluation criteria 1, 2, 5 and 6.

4.3.1 Does the Activity Result in More Than a Minimal Increase in the Frequency of Occurrence of an Accident?

INTRODUCTION From NEI 96-07, Section 3.2:

"The term 'accidents' refers to the anticipated (or abnormal) operational transients and postulated design basis accidents..."

Therefore, for purposes of 10 CFR 50.59, both Anticipated Operational Occurrences (AOOs) and Postulated Accidents (PAs) fall within the definition of "accident."

After applying the generic guidance in NEI 96-07, Section 4.3.1 to identify any accidents affected by the systems/components involved with the digital modification and examining the initiators of those accidents, the impact on the frequency of the initiator (and, hence, the accident itself) due to the digital modification can be assessed.

All accident initiators fall into one of two categories: equipment-related or personnel-related. Therefore, the assessment of the impact of a digital modification also needs to consider both equipment-related and personnel-related sources.

For a digital modification, the range of possible equipment-related sources of accident initiators includes items unique to digital and items not unique to digital. An example of an item unique to digital is consideration of the impact on accident frequency due to a software CCF, which will be addressed in this guidance. An example of a potential source of common cause failure that is not unique to digital is consideration of the impact on accident frequency due to the digital system's compatibility with the environment in which the system is being installed, which would be addressed by applying the general guidance related to meeting applicable regulatory requirements and other acceptance criteria to which the licensee is committed, and departures from standards as outlined in the general design criteria, as discussed in NEI 96-07, Section 4.3.1 and Section 4.3.1, Example 2.

For a digital modification, the assessment for personnel-related sources will consider the impact due to the Human-System Interface (HSI).

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Typically, numerical values quantifying an accident frequency are not available, so the qualitative approach using the attributable (i.e., causal relationship) and the negligible/discernable (i.e., magnitude) criteria from NEI 96-07, Section 4.3.1 will be examined in this guidance.

GUIDANCE Determination of Attributable (i.e., Causality)

NOTE: This guidance is not unique to digital and is the same as that provided in NEI 96-07, Section 4.3.1. This guidance is included here for completeness.

If none of the components/systems involved with the digital modification are identified as affecting an accident initiator previously identified in the UFSAR, then there is no attributable impact on the frequency of occurrence of an accident.

Alternately, if any component/system involved with the digital modification is identified as affecting an accident initiator previously identified in the UFSAR, then an impact on the frequency of occurrence of an accident can be attributed to the digital modification. If an attributable impact is identified, then further assessment to determine the magnitude of the impact will be performed.

Examples 4-9 and 4-10 will illustrate the application of the attributable criterion.

Example 4-9 illustrates a case of NO attributable impact on the frequency of occurrence of an accident.

Example 4-9. NO ATTRIBUTABLE Impact on the Frequency of Occurrence of an Accident Proposed Activity Description Two safety-related containment chillers exist. There are two analog control systems (one per chiller) that are physically and functionally the same.

Each analog control system will be replaced with a separate digital control system. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

Affected Accidents and Accident Initiators The review of the UFSAR accident analyses identified the Loss of Coolant Accident (LOCA) and Main Steam Line Break (MSLB) events as containing requirements related to the safety-related containment chillers. Specifically, the UFSAR states the following: "To satisfy single failure requirements, the D-26

loss of only one control system and its worst-case effect on the containment post-accident [emphasis added] environment due to the loss of one chiller has been considered in the LOCA and MSLB analyses."

Therefore, the affected accidents are LOCA and MSLB.

The UFSAR identified an equipment-related initiator for both accidents as being a pipe break. For LOCA, the pipe break occurs in a hot leg or a cold leg. For MSLB, the pipe break occurs in the main steam line exiting the steam generator.

Impact on Accident Frequency In these accidents, the safety-related containment chillers are not accident initiators (i.e., they are not pipe breaks). Furthermore, the chillers are only considered as part of accident mitigation; after the accidents have already occurred. Therefore, there is NO impact on the frequency of occurrence of the accidents that can be attributed to the digital modification.

Example 4-10 illustrates a case of an attributable impact on the frequency of occurrence of an accident.

Example 4-10. ATTRIBUTABLE Impact on the Frequency of Occurrence of an Accident Proposed Activity Description Two non-safety-related main feedwater pumps (MFWPs) exist, each with its own flow control valve. There are two analog control systems (one per MFWP and flow control valve combination) that are physically and functionally the same.

Each analog control system will be replaced with a separate digital control system. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

Affected Accident and Accident Initiators The affected accident is the Loss of Feedwater event. The UFSAR identifies the equipment-related initiators as being the loss of one MFWP or the closure of one MFWP flow control valve.

Impact on Accident Frequency In this accident, the non-safety-related feedwater system is related to the accident initiators (i.e., loss of a MFWP and/or closure of a flow control valve).

Therefore, an impact on the frequency of occurrence of the accident can be attributed to the digital modification. (NOTE: The magnitude of the impact D-27

would be assessed next.)

Determination of Negligible/Discernable (i.e., Magnitude)

NOTE: The guidance in this sub-section applies ONLY when an attributable impact on the frequency of occurrence of an accident has been established.

For proposed activities in which there is an attributable impact on the frequency of occurrence of an accident, the negligible/discernable portion of the criteria (i.e., magnitude) also needs to be assessed.

To determine the overall effect of the digital modification on the frequency of an accident, an engineering evaluation is performed. An engineering evaluation that uses a qualitative assessment to judge the failure likelihood of the modified SSC should consider each factor identified below:

Design attributes employed

Quality of the design processes, and

Operating experience of the software and hardware used (i.e., product maturity and in-service experience).

Negligible:

To achieve a negligible conclusion, the engineering evaluation of each factor (e.g., as documented in a qualitative assessment) would conclude that the affected SSC will exhibit a sufficiently low likelihood of failure, and by extension, that the change in the accident frequency "...is so small or the uncertainties in determining whether a change in frequency has occurred are such that it cannot be reasonably concluded that the frequency has actually changed (i.e., there is no clear trend toward increasing the frequency)"1

[emphasis added].

Therefore, if the qualitative assessment outcome is sufficiently low, there is not more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the UFSAR.

Discernable:

If the examination of each factor concludes that the change in the accident frequency exhibits a clear trend towards increasing the frequency, then a discernable increase in the accident frequency would exist. In this case, the software CCF likelihood could be sufficiently low or not sufficiently low.

1 Refer to NEI 96-07, Section 4.3.1, Example 1.

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The engineering evaluation (e.g., the qualitative assessment) is also used to determine if the discernible increase in the accident frequency is "more than minimal" or "NOT more than minimal." To achieve a conclusion of "NOT more than minimal," the proposed activity must continue to meet and/or satisfy all applicable NRC requirements, as well as design, material, and construction standards, to which the licensee is committed. Applicable requirements and standards include those selected by the licensee for use in the development of the proposed digital modification and documented within the design modification package.

Examples 4-11 and 4-12 illustrate the negligible/discernable portion (i.e.,

magnitude) of the criteria and assume the attributable portion of the criteria has been satisfied.

Example 4-11 illustrates a case with a negligible change to the accident frequency.

Example 4-11. NEGLIGIBLE Impact on the Frequency of Occurrence of an Accident Proposed Activity Description Two non-safety-related main feedwater pumps (MFWPs) exist, each with its own flow control valve. There are two analog control systems (one per MFWP and flow control valve combination) that are physically and functionally the same.

Each analog control system will be replaced with a separate digital control system. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

Magnitude Conclusion A qualitative assessment performed as part of the design process, considering system design attributes, quality of the design processes employed, and operating experience of the proposed equipment, concluded that the failure likelihood of the modified SSC is sufficiently low.

All applicable requirements and other acceptance criteria to which the licensee is committed, as well as applicable design, material and construction standards, continue to be met.

Therefore, the change in the frequency of occurrence of the Loss of Feedwater event is negligible due to the effect of the factors considered in the qualitative assessment.

Overall Conclusion Although an attributable impact on the frequency of occurrence of the Loss of D-29

Feedwater event was determined to exist, there was no clear trend toward increasing the frequency. With no clear trend toward increasing the frequency, there is not more than a minimal increase in the frequency of occurrence of the accident due to the digital modification.

Example 4-12 illustrates a case with a discernable increase to the accident frequency.

Example 4-12. DISCERNABLE Increase in the Frequency of Occurrence of an Accident Proposed Activity Description Same as Example 4-11.

Magnitude Conclusion Based on the qualitative assessment performed as part of the technical assessment supporting this digital modification, the likelihood of failure causing the loss of both feedwater control systems (resulting in the loss of both MFWPs) has been determined to be not sufficiently low.

All applicable requirements and other acceptance criteria to which the licensee is committed, as well as applicable design, material and construction standards, continue to be met.

The change in the frequency of occurrence of the Loss of Feedwater event is discernable due to the effect of the factors considered in the qualitative evaluation.

Overall Conclusion An attributable impact on the frequency of occurrence of the Loss of Feedwater event was determined to exist and there is a clear trend towards increasing the frequency. The clear trend toward increasing the frequency (i.e., the discernable increase) is due to the software CCF likelihood being not sufficiently low.

However, even with a clear trend towards increasing the frequency, the assessments and conclusions documented in the qualitative assessment of the considered factors and the satisfaction of applicable requirements and other acceptance criteria to which the licensee is committed, as well as applicable design, material and construction standards, there is NOT more than a minimal increase in the frequency of occurrence of the accident due to the digital modification.

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HUMAN-SYSTEM INTERFACE ASSESSMENT If no personnel-based initiators involving degraded operator performance (e.g., operator error) are identified among the accident initiators, then an increase in the frequency of the accident cannot occur due to the Human-System Interface portion of the digital modification. Otherwise, the application of the attributable criterion (i.e., causality) and the negligible/discernable criterion (i.e., magnitude) are assessed utilizing the guidance described in NEI 96-07, Section 4.3.1.

4.3.2 Does the Activity Result in More Than a Minimal Increase in the Likelihood of Occurrence of a Malfunction of an SSC Important to Safety?

INTRODUCTION After applying the generic guidance in NEI 96-07, Section 4.3.2 to identify any malfunctions affected by the systems/components involved with the digital modification and examining the initiators of those malfunctions, the impact on the likelihood of the initiator (and, hence, the malfunction itself) due to the digital modification can be assessed.

All malfunction initiators fall into one of two categories: equipment-related or personnel-related. Therefore, the assessment of the impact of a digital modification also needs to consider both equipment-related and personnel-related sources.

For a digital modification, the range of possible equipment-related sources of malfunction initiators includes items unique to digital and items not unique to digital. An example of an item unique to digital is consideration of the impact on malfunction likelihood due to a software CCF, which will be addressed in this guidance. An example of a potential source of common cause failure that is not unique to digital is consideration of the impact on malfunction likelihood due to the digital system's compatibility with the environment in which the system is being installed, which would be addressed by applying the general guidance related to meeting applicable regulatory requirements and other acceptance criteria to which the licensee is committed, and departures from standards as outlined in the general design criteria, as discussed in NEI 96-07, Section 4.3.2.

For a digital modification, the assessment for personnel-related sources will consider the impact due to the Human-System Interface (HSI).

Typically, numerical values quantifying a malfunction likelihood are not available, so the qualitative approach using the attributable (i.e., causal D-31

relationship) and the negligible/discernable (i.e., magnitude) criteria from NEI 96-07, Section 4.3.2 will be examined in this guidance.

GUIDANCE Impact on Redundancy, Diversity, Separation or Independence As discussed in NEI 96-07, Section 4.3.2, Example 6, a proposed activity that reduces redundancy, diversity, separation or independence is considered more than a minimal increase in the likelihood of a malfunction and requires prior NRC approval. However, licensees may reduce excess redundancy, diversity, separation or independence (if any) to the level credited in the safety analyses without prior NRC approval.

To ensure consistent application of this guidance, each of these characteristics is reviewed below.

Redundancy:

"Redundancy" means two or more SSCs performing the same design function.

The introduction of the exact same software into redundant channels and the potential creation of a software CCF has no impact on an SSCs' redundancy because the SSCs perform the same design function(s) before the introduction of software as they will after the introduction of software.

Diversity:

"Diversity" is not defined within the regulations as a stand-alone term. The term is defined within the context of GDC 22, as follows:

"Criterion 22 -- Protection system independence. The protection system shall be designed to assure that the effects of natural phenomena, and of normal operating, maintenance, testing, and postulated accident conditions on redundant channels do not result in loss of the protection function, or shall be demonstrated to be acceptable on some other defined basis. Design techniques, such as functional diversity or diversity in component design and principles of operation, shall be used to the extent practical to prevent loss of the protection function."

[emphasis added]

Therefore, "diversity" is addressed in terms of functional or component design and principles of operation.

The introduction of the exact same software and the potential creation of a software CCF into single-failure proof channels, or merely redundant channels, has no impact on diversity because the channels were not initially diverse. Namely, each of the channels used the same principles of operation D-32

and they all contained identical components. Thus, the channels were identical before the introduction of software and will remain identical after the introduction of software.

Separation:

"Separation" refers to physical arrangement to provide missile protection, or to eliminate or minimize the detrimental impacts due to fires, floods, etc.

The introduction of the exact same software and the potential creation of a software CCF does not impact the physical arrangement of SSCs.

Independence:

"Independence" means non-interaction of SSCs.

Assuming that no interactions (e.g., communication between multiple applications of the software) exist, the introduction of the exact same software and the potential creation of a software CCF does not impact the independence of SSCs. However, the failure of such software due to a software CCF is possible and is addressed in Evaluation criterion #5 and/or

6.

Determination of Attributable (i.e., Causality)

NOTE: This guidance is not unique to digital and is the same as that provided in NEI 96-07, Section 4.3.2. This guidance is included here for completeness.

If none of the components/systems involved with the digital modification are identified as affecting a malfunction initiator previously identified in the UFSAR, then there is no attributable impact on the likelihood of occurrence of a malfunction.

Alternately, if any components/systems involved with the digital modification are identified as affecting a malfunction initiator previously identified in the UFSAR, then an impact on the likelihood of occurrence of a malfunction can be attributed to the digital modification. If an attributable impact is identified, then further assessment to determine the magnitude of the impact will be performed.

Example 4-13 illustrates a case of an attributable impact on the likelihood of occurrence of a malfunction.

Example 4-13. ATTRIBUTABLE Impact on the Likelihood of Occurrence of a Malfunction Proposed Activity Description Two safety-related containment chillers exist. There are two analog control D-33

systems (one per chiller) that are physically and functionally the same.

Each analog control system will be replaced with a separate digital control system. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

Affected Malfunctions and Malfunction Initiators The affected malfunction is the failure of a safety-related containment chiller to provide its cooling design function. The UFSAR identifies three specific equipment-related initiators of a containment chiller malfunction: (1) failure of the Emergency Diesel Generator (EDG) to start (preventing the EDG from supplying electrical power to the containment chiller it powers), (2) an electrical failure associated with the chiller system (e.g., feeder breaker failure), and (3) a mechanical failure within the chiller itself (e.g., flow blockage). The UFSAR also states that the single failure criteria were satisfied because two chillers were provided and there were no common malfunction sources.

Impact on Malfunction Likelihood Although the safety-related chiller control system is not one of the three malfunction initiators identified in the UFSAR, a new common malfunction source has been introduced due to the potential for a software common cause failure from the exact same software being used in both digital control systems. A common malfunction initiator was previously considered, but was concluded to be non-existent. However, this conclusion is no longer valid.

Therefore, an impact on the likelihood of occurrence of the malfunction can be attributed to the digital modification. (NOTE: The magnitude of the impact would be assessed next.)

Determination of Negligible/Discernable (i.e., Magnitude)

NOTE: The guidance in this sub-section applies ONLY when an attributable impact on the likelihood of occurrence of a malfunction has been established.

For proposed activities in which there is an attributable impact on the likelihood of occurrence of a malfunction, the negligible/discernable portion of the criteria (i.e., magnitude) also needs to be assessed.

To determine the overall effect of the digital modification on the likelihood of a malfunction, an engineering evaluation is performed. An engineering evaluation that uses a qualitative assessment to judge the failure likelihood of the modified SSC should consider each factor identified below:

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Design attributes employed

Quality of the design processes, and

Operating experience of the software and hardware used (i.e., product maturity and in-service experience).

Negligible:

To achieve a negligible conclusion, the engineering evaluation of each factor (e.g., as documented in a qualitative assessment) would conclude that the affected SSC will exhibit a sufficiently low likelihood of failure, and by extension, that the change in the malfunction likelihood "...is so small or the uncertainties in determining whether a change in likelihood has occurred are such that it cannot be reasonably concluded that the likelihood has actually changed (i.e., there is no clear trend toward increasing the likelihood)"2

[emphasis added].

Therefore, if the qualitative assessment outcome is sufficiently low, there is not more than a minimal increase in the likelihood of occurrence of a malfunction of an SSC important to safety previously evaluated in the UFSAR.

Discernable:

If the examination of each factor concludes that the change in the malfunction likelihood exhibits a clear trend towards increasing the likelihood, then a discernable increase in the malfunction likelihood would exist. In this case, the software CCF likelihood could be sufficiently low or not sufficiently low.

The engineering evaluation (e.g., the qualitative assessment) is also used to determine if the discernible increase in the malfunction likelihood is "more than minimal" or "NOT more than minimal." To achieve a conclusion of "NOT more than minimal," the proposed activity must continue to meet and/or satisfy all applicable NRC requirements, as well as design, material, and construction standards, to which the licensee is committed. Applicable requirements and standards include those selected by the licensee for use in the development of the proposed digital I&C design modification and documented within the design modification package.

Examples 4-14 and 4-15 illustrate the negligible/discernable portion (i.e.,

magnitude) of the criteria and assume the attributable portion of the criteria has been satisfied.

Example 4-14 illustrates a case with a negligible change to the malfunction likelihood.

2 Refer to NEI 96-07, Section 4.3.2, 4th paragraph.

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Example 4-14. NEGLIGIBLE Impact in the Likelihood of Occurrence of a Malfunction Proposed Activity Description Two non-safety-related main feedwater pumps (MFWPs) exist, each with its own flow control valve. There are two analog control systems (one per MFWP and flow control valve combination) that are physically and functionally the same.

Each analog control system will be replaced with a separate digital control system. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

Magnitude Conclusion A qualitative assessment performed as part of the design process, considering system design attributes, quality of the design processes employed, and operating experience of the proposed equipment, concluded that the failure likelihood of the modified SSC is sufficiently low.

All applicable requirements and other acceptance criteria to which the licensee is committed, as well as applicable design, material and construction standards, continue to be met.

Therefore, the change in the likelihood of occurrence of the loss of a MFWP or the closure of a MFWP flow control valve initiated by the failure of a feedwater control system is negligible due to the effect of the factors considered in the qualitative assessment.

Overall Conclusion Although an attributable impact on the likelihood of occurrence of the loss of a MFWP or the closure of a MFWP flow control valve was determined to exist, there was no clear trend toward increasing the likelihood. With no clear trend toward increasing the likelihood, there is not more than a minimal increase in the likelihood of occurrence of the malfunctions due to the digital modification.

Example 4-15 illustrates a case with a discernable increase to the malfunction likelihood.

Example 4-15. DISCERNABLE Increase in the Likelihood of Occurrence of a Malfunction Proposed Activity Description Two safety-related main control room chillers exist. There are two analog D-36

control systems (one per chiller) that are physically and functionally the same.

Each analog control system will be replaced with a separate digital control system. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

The logic components/system and controls for the starting and operation of the safety injection pumps are located within the main control room boundary. The environmental requirements associated with the logic components/system and controls are maintained within their allowable limits by the main control room cooling system, which includes the chillers involved with this digital modification.

Affected Malfunction and Malfunction Initiator The review of the UFSAR accident analyses identified several events for which the safety injection pumps are assumed to start and operate (as reflected in the inputs and assumptions to the accident analyses).

In each of these events, the UFSAR states the following: "To satisfy single failure requirements, the loss of only one chiller control system and its worst-case effect on the event due to the loss of one chiller has been considered in the accident analyses."

Magnitude Conclusion Based on the qualitative assessment performed as part of the technical assessment supporting this digital modification, the likelihood of a failure impacting both chiller control systems has been determined to be not sufficiently low.

The change in the likelihood of occurrence of the malfunction of both safety injection pumps is discernable due to the outcome of the qualitative assessment. Specifically, single failure criteria are no longer met.

Overall Conclusion An attributable impact on the likelihood of occurrence of the malfunction of both safety injection pumps was determined to exist and there is a clear trend toward increasing the likelihood. The clear trend toward increasing the likelihood (i.e., the discernable increase) is due to the failure being not sufficiently low which, in this case, causes single failure criteria to not be satisfied.

With a clear trend toward increasing the likelihood and failure to satisfy single failure criteria, there is more than a minimal increase in the likelihood of occurrence of the malfunction of both logic components/system and controls D-37

for the starting and operation of the safety injection pumps due to the digital modification.

HUMAN-SYSTEM INTERFACE ASSESSMENT If no personnel-based initiators involving degraded operator performance (e.g., operator error) are identified among the malfunction initiators, then an increase in the likelihood of the malfunction cannot occur due to the Human-System Interface portion of the digital modification. Otherwise, the application of the attributable criterion (i.e., causality) and the negligible/discernable criterion (i.e., magnitude) are assessed utilizing the guidance described in NEI 96-07, Section 4.3.2.

4.3.3 Does the Activity Result in More Than a Minimal Increase in the Consequences of an Accident?

There is no unique guidance applicable to digital modifications for responding to this Evaluation criterion because the identification of affected accidents and dose analysis inputs and/or assumptions are not unique for a digital modification. The guidance in NEI 96-07, Section 4.3.3 applies.

4.3.4 Does the Activity Result in More Than a Minimal Increase in the Consequences of a Malfunction?

There is no unique guidance applicable to digital modifications for responding to this Evaluation criterion because the identification of the affected malfunctions and dose analysis inputs and/or assumptions are not unique for a digital modification. The guidance in NEI 96-07, Section 4.3.4 applies.

4.3.5 Does the Activity Create a Possibility for an Accident of a Different Type?

INTRODUCTION From NEI 96-07, Section 3.2:

"The term 'accidents' refers to the anticipated (or abnormal) operational transients and postulated design basis accidents..."

Therefore, for purposes of 10 CFR 50.59, both Anticipated Operational Occurrences (AOOs) and Postulated Accidents (PAs) fall within the definition of "accident."

From NEI 96-07, Section 4.3.5, the two considerations that need to be assessed when answering this Evaluation question are as likely to happen as D-38

and the impact on the accident analyses (i.e., a new analysis will be required or a revision to a current analysis is possible).

GUIDANCE Determination of "As Likely To Happen As" From NEI 96-07, Section 4.3.5:

"The possible accidents of a different type are limited to those that are as likely to happen as those previously evaluated in the UFSAR. The accident must be credible in the sense of having been created within the range of assumptions previously considered in the licensing basis (e.g.,

random single failure, loss of off-site power, etc.)."

If the failure likelihood of the modified SSC is determined to be sufficiently low, then the activity does not introduce any failures that are as likely to happen as those in the UFSAR that can initiate an accident of a different type. Therefore, the activity does not create a possibility for an accident of a different type than any previously evaluated in the UFSAR.

Alternately, if the failure likelihood of the modified SSC is determined to be not sufficiently low, then the activity does introduce failures that are as likely to happen as those in the UFSAR that can initiate an accident of a different type. In this case, further assessment to determine the impact on the accident analysis is to be performed.

Determination of Accident Analysis Impact NOTE: This guidance is not unique to digital and is the same as that provided in NEI 96-07, Section 4.3.5, as clarified in RG 1.187.

For the case in which the creation of a possibility for an accident of a different type is as likely to happen as those in the UFSAR, the accident analysis impact also needs to be assessed to determine whether the accident is, in fact, a different type.

There are two possible impacts on the accident analysis:

(1) a revision to an existing analysis is possible, or (2) a new analysis will be required because the effect on the plant is different than any previously evaluated in the UFSAR Accidents of a different type are accidents that are as likely to happen as those in the UFSAR for which a new accident analysis would be needed, not just a revision of a current accident analysis.

Example 4-16 illustrates the NO CREATION of the possibility of an accident of a different type case.

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Example 4-16. NO CREATION of the Possibility of an Accident of a Different Type Proposed Activity Two non-safety-related main feedwater pumps (MFWPs) exist, each with its own flow control valve. There are two analog control systems (one per MFWP and flow control valve combination) that are physically and functionally the same.

Each analog control system will be replaced with a separate digital control system. The hardware platform for each digital control system is from the same supplier and the software in each digital control system is exactly the same.

Malfunction / Accident Initiator The malfunction/accident initiator identified in the UFSAR for the analog main feedwater control system is the loss of one main feedwater pump (out of two pumps) due to the loss of one feedwater control system.

Accident Frequency and Type The pertinent accident is the Loss of Feedwater event. The characteristics of the Loss of Feedwater event are as follows:

Type of Accident - Decrease in Heat Removal by the Secondary System Accident Category - Infrequent Incident As Likely to Happen As Conclusion Based on the qualitative assessment performed as part of the technical assessment supporting this digital modification, the failure likelihood of the modified SSC, causing the loss of both feedwater control systems (resulting in the loss of both MFWPs) has been determined to be sufficiently low.

Therefore, in this case, the creation of a possibility for an accident of a different type is NOT as likely to happen as those in the UFSAR and there is no need to determine the accident analysis impact.

Example 4-17 illustrates the CREATION of the possibility of an accident of a different type case.

Example 4-17. CREATION of the Possibility of an Accident of a Different Type Proposed Activity Two non-safety-related analog feedwater control systems and one non-safety-D-40

related main turbine steam-inlet valves analog control system exist.

The two feedwater control systems and the one main turbine steam-inlet valves control system will be combined into a single digital control system.

Malfunction / Accident Initiator The identified feedwater control system malfunctions include (a) failures causing the loss of all feedwater to the steam generators [evaluated in the Loss of Feedwater event] and (b) failures causing an increase in main feedwater flow to the maximum output from both MFWPs [evaluated in the Excess Feedwater event].

The identified main turbine steam-inlet valve control system malfunctions include (a) all valves going fully closed causing no steam to be admitted into the turbine [evaluated in the Loss of Load event] and (b) all valves going fully open causing excess steam to be admitted into the turbine [evaluated in the Excess Steam Demand event].

Accident Frequency and Type The characteristics of the pertinent accidents are as follows:

Loss of Feedwater:

Type of Accident - Decrease in Heat Removal by the Secondary System Accident Category - Infrequent Incident Excess Feedwater:

Type of Accident - Increase in Heat Removal by the Secondary System Accident Category - Moderate Frequency Incident Loss of Load:

Type of Accident - Decrease in Heat Removal by the Secondary System Accident Category - Moderate Frequency Incident Excess Steam Demand:

Type of Accident - Increase in Heat Removal by the Secondary System Accident Category - Moderate Frequency Incident As Likely to Happen As Conclusion Based on the qualitative assessment performed as part of the technical D-41

assessment supporting this digital modification, the failure likelihood of the modified SSC impacting both the feedwater control systems and the main turbine steam-inlet valves control system has been determined to be not sufficiently low.

Therefore, in this case, the following conditions are as likely to happen as those in the UFSAR, creating a possibility for several accidents:

(1) Loss of both feedwater pumps (2) Increase in main feedwater flow to the maximum output from both MFWPs.

(3) All main turbine steam-inlet valves going fully closed (4) All main turbine steam-inlet valves going fully open (5) Combination of (1) and (3)

(6) Combination of (1) and (4)

(7) Combination of (2) and (3)

(8) Combination of (2) and (4)

Accident Analysis Impact Conclusion Conditions (1) though (4) are already considered in the safety analyses, so a revision to an existing analysis is possible. Thus conditions (1) through (4) are NOT accidents of a different type.

The current set of accidents identified in the safety analyses does not consider a simultaneous Feedwater event (i.e., Loss of Feedwater or Excess Feedwater) with a Main Steam event (i.e., Excess Steam Demand or Loss of Load).

Condition (5) still causes a decrease in heat removal by the secondary system.

Condition (6) involves both a decrease and an increase in heat removal by the secondary system.

Condition (7) involves both a decrease and an increase in heat removal by the secondary system.

Condition (8) still causes an increase in heat removal by the secondary system.

Conditions (5) though (8) will require new accident analyses to be performed. As such, conditions (5) though (8) are accidents of a different type. Therefore, the proposed activity does create the possibility of accidents of a different type.

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HUMAN-SYSTEM INTERFACE ASSESSMENT If no personnel-based initiators involving degraded operator performance (e.g., operator error) are identified as accident initiators, then the creation of a possibility for an accident of a different type cannot occur due to the Human-System Interface portion of the digital modification. Otherwise, the creation of a possibility for an accident of a different type is assessed utilizing the guidance described in NEI 96-07, Section 4.3.5.

4.3.6 Does the Activity Create a Possibility for a Malfunction of an SSC Important to Safety with a Different Result?

INTRODUCTION NOTE: Due to the unique nature of digital modifications, and the inherent complexities therein, the application of this criterion is especially important. Specifically, the unique aspect of concern is the potential for a software CCF to create the possibility for a malfunction with a different result. Therefore, rather than simply providing supplemental guidance to that already included in NEI 96-07, Section 4.3.6, more detailed guidance will be provided in this section.

However, none of the more detailed guidance provided in this section conflicts with that provided in NEI 96-07, Section 4.3.6, or should be construed as being new, or modified from that in NEI 96-07, Section 4.3.6.

Review To ensure the unique aspects of digital modifications are addressed correctly and adequately, a review of selected discussions and excerpts from NEI 96-07, including malfunctions, design functions, and safety analyses, is presented first.

From NEI 96-07, Section 3.9:

Malfunction of SSCs important to safety means the failure of SSCs to perform their intended design functions described in the UFSAR (whether or not classified as safety-related in accordance with 10 CFR 50, Appendix B). [emphasis added]

From NEI 96-07, Section 3.3:

Design functions are UFSAR-described design bases functions and other SSC functions described in the UFSAR that support or impact design bases functions... [emphasis added]

Also, D-43

Design bases functions are functions performed by systems, structures and components (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. [emphasis added]

Furthermore, Design functions...include functions that, if not performed, would initiate a transient or accident that the plant is required to withstand. [emphasis added]

Finally, As used above, credited in the safety analyses means that, if the SSC were not to perform its design bases function in the manner described, the assumed initial conditions, mitigative actions or other information in the analyses would no longer be within the range evaluated (i.e., the analysis results would be called into question). The phrase support or impact design bases functions refers both to those SSCs needed to support design bases functions (cooling, power, environmental control, etc.) and to SSCs whose operation or malfunction could adversely affect the performance of design bases functions (for instance, control systems and physical arrangements).

Thus, both safety-related and nonsafety-related SSCs may perform design functions. [emphasis added]

This definition is oriented around the definition of design bases function, which itself is defined in NEI 97-04, Appendix B, Guidelines and Examples for Identifying 10 CFR 50.2 Design Bases, endorsed by Regulatory Guide 1.186, and highlighted in bold above.

A more complete understanding of the meaning of a design basis function can be obtained by examination of NEI 97-04, Appendix B. From NEI 97-04, the three characteristics of design bases functions are summarized as follows:

1. Design bases functions are credited in the safety analyses.

2. The functions of any individual SSC are functionally below that of a design basis function.

3. Design bases functions are derived primarily from the General Design Criteria.

Repeating a portion from above to highlight the importance of identifying the design basis function and its connection to a safety analysis result, we have the following:

As used above, credited in the safety analyses means that, if the SSC were not to perform its design bases function in the D-44

manner described, the assumed initial conditions, mitigative actions or other information in the analyses would no longer be within the range evaluated (i.e., the analysis results would be called into question). [emphasis added]

Then, from NEI 96-07, Section 3.12:

Safety analyses are analyses performed pursuant to NRC requirements to demonstrate the integrity of the reactor coolant pressure boundary, the capability to shut down the reactor and maintain it in a safe shutdown condition, or the capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposures comparable to the guidelines in 10 CFR 50.34(a)(1) or 10 CFR 100.11...and include, but are not limited to, the accident analyses typically presented in Chapter 15 of the UFSAR. [emphasis added]

And from the first sentence of the associated discussion:

Safety analyses are those analyses or evaluations that demonstrate that acceptance criteria for the facilitys capability to withstand or respond to postulated events are met.

[emphasis added]

Failure Modes and Effects Analysis (FMEA)

NEI 96-07, Section 4.3.6 recognizes that the effect of a proposed modification must be assessed. This assessment may require the use of a failure modes and effects analysis (FMEA), including the possible creation of a new FMEA.

From NEI 96-07, Section 4.3.6:

In evaluating a proposed activity against this criterion, the types and results of failure modes of SSCs that have previously been evaluated in the UFSAR and that are affected by the proposed activity should be identified. This evaluation should be performed consistent with any failure modes and effects analysis (FMEA) described in the UFSAR, recognizing that certain proposed activities may require a new FMEA to be performed. [emphasis added]

Overall Perspective NEI 96-07, Section 4.3.6 provides the overall perspective on this Evaluation criterion with its first sentence, which states:

Malfunctions of SSCs are generally postulated as potential single failures to evaluate plant performance with the focus being on the result of the malfunction rather than the cause or type of malfunction.

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Expanding upon this foundation, the following conclusion is reached, which is based upon discussion from 63 FR 56106:

Unless the equipment would fail in a way not already evaluated in the safety analysis, there can be no malfunction of an SSC important to safety with a different result. [emphasis added]

From NEI 96-07, Section 4.3.6, there are two considerations that need to be assessed when answering this criterion: as likely to happen as and impact on the safety analysis result.

GUIDANCE Determination of "As Likely to Happen As" From NEI 96-07, Section 4.3.6:

The possible malfunctions with a different result are limited to those that are as likely to happen as those described in the UFSARa proposed change or activity that increases the likelihood of a malfunction previously thought to be incredible to the point where it becomes as likely as the malfunctions assumed in the UFSAR could create a possible malfunction with a different result. [emphasis added]

If the failure likelihood of the modified SSC is determined to be sufficiently low, then the activity does not introduce any failures that are as likely to happen as those in the UFSAR. Therefore, the activity does not create a possibility for a malfunction of an SSC important to safety with a different result from any other previously evaluated in the UFSAR.

Alternately, if the failure likelihood of the modified SSC is determined to be not sufficiently low, then the activity does introduce failures that are as likely to happen as those in the UFSAR. In this case, further assessment to determine the impact of the malfunction on the safety analysis result is to be performed.

Example 4-18 illustrates the NO CREATION of the possibility for a malfunction with a different result due to applying the as likely to happen as consideration.

Example 4-18. NO CREATION of the Possibility for a Malfunction with a Different Result Proposed Activity A large number of analog transmitters are being replaced with digital transmitters. These transmitters perform a variety of functions, including controlling the automatic actuation of devices (e.g., valve D-46

stroking) that are credited in a safety analysis.

Conclusion Based on the qualitative assessment, the failure likelihood of the modified SSC has been determined to be sufficiently low.

Therefore, a malfunction with a different result is NOT as likely to happen as those described in the UFSAR and there is no need to determine the impact of the malfunction on the safety analysis result. Thus, the proposed activity does NOT create the possibility for a malfunction of an SSC important to safety with a different result.

Determination of Safety Analysis Result Impact The generic process to determine the impact of a malfunction of an SSC important to safety on the safety analyses, i.e., a comparison of the safety analyses results to identify any different results, consists of multiple steps, as summarized next.

Step 1: Identify the functions directly or indirectly related to the proposed modification.

Considering the scope of the proposed digital modification, identify the functions that are directly or indirectly related to the proposed activity.

Step 2: Identify which of the functions from Step 1 are Design Functions and/or Design Bases Functions.

Utilizing NEI 96-07, Section 3.3, classify the functions from Step 1. If no design functions are identified, then the proposed activity does NOT create the possibility for a malfunction of an SSC important to safety with a different result.

Utilizing NEI 96-07, Section 3.3, along with Appendix B to NEI 97-04, as needed, identify which design functions are design bases functions, which design functions support or impact design bases functions, and which design functions are not involved with design bases functions, but are functions that if not performed would initiate a transient or accident that the plant is required to withstand. If no design basis functions are involved, proceed to Step 5.

The process for determining if a design function is a design basis function is aided by identifying the associated General Design Criteria (GDC) to which a design bases function applies. Each design function can then be related to the requirements discussed within the GDC to determine if that design function is directly involved with the design basis function itself or if the design function supports or impacts the related design basis function. If the design function is found to directly D-47

involve the GDC requirement, then that design function is a design basis function. If the design function supports or impacts the GDC requirement, then it is not a design basis function, but is still credited in the safety analysis.

Step 3: Determine if a new FMEA needs to be generated.

If the impact on the design basis function involved is readily apparent, no new FMEA needs to be generated, skip this step and go to Step 4.

For example, there is no reason to contemplate the generation of a new FMEA if the impact of the failure on the design bases functions is recognized as being immediate. Otherwise, generate the new FMEA to describe the connection of the proposed activity, or failures due to the proposed activity, to an impact on the design bases functions.

As part of the process for generating the new FMEA, presume compliance with pre-existing/interdependent, modification-related procedures and utilization of existing equipment to determine if adequate options exist to mitigate potential detrimental impacts on design functions.

Interdependence is discussed in NEI 96-07, Sections 4.2 and 4.3. An example of an interdependent procedure change would be the modifications to an existing procedure to reflect operation of the new digital equipment and controls, including any new features such as a control system restart option.

Step 4: Determine if each design basis function continues to be performed/satisfied.

If all design basis functions continue to be performed/satisfied, and there are no other design functions involved, then the proposed activity does NOT create the possibility for a malfunction of an SSC important to safety with a different result.

For any design basis function that does not continue to be performed/satisfied, or other design functions that are involved, continue to Step 5.

Step 5: Identify all safety analyses involved.

Identify all safety analyses that rely directly or indirectly on the design basis functions performance/satisfaction. Also, identify all safety analyses related to any other design function that could impact either the accidents initiation or the events initial conditions, i.e., design functions that, if not performed, would initiate a transient or accident that the plant is required to withstand.

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If there are no safety analyses involved, then there has been no change in the result of a safety analysis and the proposed activity does NOT create the possibility for a malfunction of an SSC important to safety with a different result.

Step 6: For each safety analysis involved, compare the projected/postulated results with the previously evaluated results.

NEI 96-07, Section 4.3.6 provides the following guidance regarding the identification of failure modes and effects:

Once the malfunctions previously evaluated in the UFSAR and the results of these malfunctions have been determined, then the types and results of failure modes that the proposed activity could create are identified.

If any of the identified safety analyses have become invalid due to their basic assumptions no longer being valid (e.g., single failure assumption is not maintained), or if the numerical result(s) of any safety analysis would no longer satisfy the acceptance criteria, then the proposed activity DOES create the possibility for a malfunction of an SSC important to safety with a different result.

As part of the response and determining if the safety analyses acceptance criteria continue to be satisfied, include the impact on the severity of the initiating conditions and the impact on the initial conditions assumed in the safety analysis. Specifically, consider any design functions that, if not performed, would initiate a transient or accident that the plant is required to withstand.

Examples 4-19 through 4-24 illustrate cases in which the failure likelihood of the modified SSC is determined to be not sufficiently low and, by extension, the likelihood of a software CCF is also determined to be not sufficiently low, i.e., a malfunction is as likely to happen as those described in the UFSAR. In these cases, the multi-step process applying the safety analysis result impact consideration is performed to determine the impact of the malfunction on the safety analysis result.

Examples 4-19 through 4-23 illustrate some cases of NO CREATION of a malfunction with a different result.

Example 4-19. NO CREATION of a Malfunction with a Different Result Proposed Activity A feedwater control system is being upgraded from an analog system to a digital system. New components are being added that could fail in D-49

ways other than the components in the original design. Now, as a result of this change, all four feedwater flow control valves could simultaneously fail closed following a software CCF.

Safety Analysis Result Impact Consideration Step 1:

The identified function is to establish and maintain steam generator water level within predetermined physical limits during normal operating conditions.

Step 2:

The function is classified as a design function due to its ability to initiate a transient or accident that the plant is required to withstand. However, the design function is not a design basis function. With no design basis functions involved, proceed to Step 5.

Step 3:

Not applicable Step 4:

Not applicable Step 5:

The pertinent safety analysis is the accident analysis for Loss of Feedwater. The feedwater control system has a direct impact on the accident analysis assumptions and modeling.

Step 6:

The severity of the initiating failure for the Loss of Feedwater is unchanged. The event already assumes a total loss of feedwater flow.

The newly created failure modes are determined to have no effect on this assumption. The manner in which feedwater flow is lost has no impact on the initial conditions of the event.

Conclusion Although the software CCF likelihood was determined to be not sufficiently low (i.e., a malfunction is as likely to happen as those described in the UFSAR), the initiation severity of the Loss of Feedwater event, the newly created failure modes and the manner in which feedwater flow was lost do not change the result of the safety analysis. Thus, the proposed activity does NOT create the possibility for a malfunction of an SSC important to safety with a different result.

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Example 4-20. NO CREATION of a Malfunction with a Different Result Proposed Activity A feedwater control system is being upgraded from an analog system to a digital system. Previously, only one of four feedwater flow control valves was assumed to fail open as part of the initiation of the Excess Feedwater event. Now, as a result of this change, all four feedwater flow control valves could simultaneously fail open following a software CCF.

Safety Analysis Result Impact Consideration Step 1:

The identified function is to establish and maintain steam generator water level within predetermined physical limits during normal operating conditions.

Step 2:

The function is classified as a design function due to its ability to initiate a transient or accident that the plant is required to withstand. However, the design function is not a design basis function. With no design basis functions involved, proceed to Step 5.

Step 3:

Not applicable Step 4:

Not applicable Step 5:

The pertinent safety analysis is the accident analysis for Excess Feedwater. The feedwater control system has a direct impact on the accident analysis assumptions and modeling.

Step 6:

The severity of the initiating failure has increased due to four valves supplying flow as compared to one valve prior to the change.

The minimum allowed departure from nucleate boiling ratio (DNBR) to satisfy the accident analysis acceptance limit is 1.30. The current minimum DNBR result is 1.42. After using an increased value for the new feedwater flow (to represent the increase in feedwater flow caused D-51

by the opening of the four feedwater flow control valves) in a revision to the Excess Feedwater accident analysis, the new minimum DNBR result is 1.33.

Conclusion Although the software CCF likelihood was determined to be not sufficiently low (i.e., a malfunction is as likely to happen as those described in the UFSAR) and the severity of the initiating failure has increased, the new minimum DNBR result continues to satisfy the accident analysis acceptance limit, which does not change the result of the safety analysis. Therefore, the proposed activity does NOT create the possibility for a malfunction of an SSC important to safety with a different result.

Example 4-21. NO CREATION of a Malfunction with a Different Result Proposed Activity A complete system upgrade to the area radiation monitors that monitor a variety of containment compartments that could be subject to radioactive releases during a LOCA is proposed. The outdated analog-based radiation monitors are being replaced by digitally-based monitors. The hardware platform for each area radiation monitor is from the same supplier and the software in each area radiation monitor is exactly the same.

Safety Analysis Result Impact Consideration Step 1:

The functions include the monitoring of the various compartments, rooms and areas that may be subject to an increase in radiation during the recirculation phase of a LOCA.

Step 2:

In this case, whether the function is a design bases function is not readily determined, so the associated GDC will be identified and examined.

Criterion 64 -- Monitoring radioactivity releases. Means shall be provided for monitoring the reactor containment atmosphere, spaces containing components for recirculation of loss-of-coolant accident fluids, effluent discharge paths, and the plant environs for radioactivity that may be released from normal operations, including anticipated operational occurrences, and from postulated accidents.

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[emphasis added]

The area radiation monitors perform a function that is necessary to comply with a requirement specified in GDC 64. Therefore, the radiation monitor's function is directly involved with a design basis function.

Step 3:

No new FMEA needs to be generated. The effect of a postulated software CCF on the design basis function involved is readily apparent.

Step 4:

If a software CCF occurs, the area radiation monitors will not perform their design function that supports or impacts a design basis function.

Thus, the design basis function will not be performed/satisfied.

Step 5:

There are no safety analyses that directly or indirectly credit this design basis function. That is, there are no considerations of malfunctions of single or multiple radiation monitors in any safety analysis.

Step 6:

Not applicable Conclusion The cited GDC does not contain any reference to single failure protection, so there is no distinction between a failure of a single radiation monitor or multiple radiation monitors.

Although the software CCF likelihood was determined to be not sufficiently low (i.e., a malfunction is as likely to happen as those described in the UFSAR), there are no safety analyses that directly or indirectly credit the design basis function. Thus, there cannot be a different result when comparing to a pre-existing safety analysis since none exists.

Therefore, the proposed activity does NOT create the possibility of a malfunction of an SSC important to safety with a different result.

NOTE: The acceptability of these new area radiation monitors will be dictated by their reliability, which is assessed as part of Criterion #2, not Criterion #6.

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Example 4-22. NO CREATION of a Malfunction with a Different Result Proposed Activity Two chillers that cool the Main Control Room Ventilation System (MCRVS) are being upgraded. As part of the upgrade, each analog control system will be replaced with a digital control system. Each digital control system maintains all of the operational features (e.g.,

auto/manual start/stop, setpoints and alarms) as the analog control systems. The hardware platform for each chiller control system is from the same supplier and the software in each chiller control system is exactly the same.

Safety Analysis Result Impact Consideration Step 1:

The MCRVS also cools the Relay Room that is adjacent to the main control room. The Relay Room contains multiple instrument racks that control both Reactor Protection and Safeguards actuation signals.

The air flow path from the Main Control Room to the Relay Room is described in the UFSAR, along with a function to maintain the Relay Rooms temperature less than or equal to 120 ºF.

Step 2:

In this case, whether the function is a design bases function is not readily determined, so the associated GDC will be identified and examined.

Criterion 20 -- Protection system functions. The protection system shall be designed (1) to initiate automatically the operation of appropriate systems including the reactivity control systems, to assure that specified acceptable fuel design limits are not exceeded as a result of anticipated operational occurrences and (2) to sense accident conditions and to initiate the operation of systems and components important to safety. [emphasis added]

The chillers and the chiller control systems perform a function that supports or impacts the design basis function specified in GDC 20. Therefore, the chillers and the chillers control systems functions are design functions credited in the safety analysis.

Step 3:

The impact of a software CCF on the design bases functions is not readily apparent, so a new FMEA was generated.

Step 4:

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The new FMEA concluded that compliance with pre-existing procedures will result in the restoration of at least one chiller well before the Relay Room cooling becomes inadequate. Specifically, compliance with existing procedures will direct the recognition of the problem and the restoration of the chillers function prior to the impairment of the associated design basis functions. In addition, an interdependent procedure change involved the use of the control system restart feature to reinitialize the control system, which would clear any software faults, allowing the chiller functions to be restored well before the Relay Room cooling becomes inadequate.

Step 5:

Although none of the safety analyses specifically identify assumptions or inputs related to the MCRVS, the Relay Room or the components therein, several accident analyses assume correct and timely actuation of the Reactor Protection and Safeguards features. As determined in Step 2 above, the chillers operation is considered to be credited in the safety analysis since they support or impact the design bases functions associated with GDC 20. As demonstrated as part of Step 4, all design basis functions are preserved.

Step 6:

As determined in Step 4, all design basis functions are preserved.

Therefore, all of the safety analyses identified in Step 5 remain valid and there is no change in any safety analysis result.

Conclusion Although the software CCF likelihood was determined to be not sufficiently low (i.e., a malfunction is as likely to happen as those described in the UFSAR), the design bases functions will continue to be performed/satisfied and the safety analyses (and all of the results from these analyses) are unaffected. Therefore, the proposed activity does NOT create the possibility of a malfunction of an SSC important to safety with a different result.

Example 4-23. NO CREATION of a Malfunction with a Different Result Proposed Activity Currently, the feedwater control system and the pressurizer pressure control system are separate analog control systems.

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The feedwater control system is being upgraded from an analog to a digital system. Previously, only one of four feedwater flow control valves was assumed to fail open as part of the initiation of the Excess Feedwater event. Now, as a result of this change, all four feedwater flow control valves could simultaneously fail open following a software CCF.

The pressurizer pressure control system is being upgraded from an analog to a digital system.

As part of this modification, the two previously separate control systems will be combined within the same digital controller in a distributed control system (DCS) with the same software controlling all feedwater and pressurizer functions.

Safety Analysis Result Impact Consideration Step 1:

Feedwater - The identified function is to establish and maintain steam generator water level within predetermined physical limits during normal operating conditions.

Pressurizer - The identified function is control of the pressurizer sprays and heaters.

Step 2:

Feedwater - The function is classified as a design function due to its ability to initiate a transient or accident that the plant is required to withstand.

However, the design function is not a design bases function.

Pressurizer - In this case, whether the function is a design bases function is not readily determined, so the associated GDC will be identified and examined.

Criterion 10 -- Reactor design. The reactor core and associated coolant, control, and protection systems shall be designed with appropriate margin to assure that specified acceptable fuel design limits are not exceeded during any condition of normal operation, including the effects of anticipated operational occurrences. [emphasis added]

The pressurizer control system performs a function that supports or impacts a design basis function specified in GDC 10. Therefore, the pressurizer control systems function is a design function and is credited in the safety analysis.

Step 3:

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The effect on the feedwater and pressurizer control systems is clear and understood, having a direct impact on the accident analysis assumptions and modeling. There is no reason to contemplate the generation of a new FMEA since the impact of the software CCF on the accident analysis is readily apparent (i.e., clear and understood).

Step 4:

If a software CCF occurs, the pressurizer pressure control function, which supports or impacts the GDC 10 design basis function, will not continue to be performed/satisfied.

Step 5:

The pertinent safety analysis is the accident analysis for Excess Feedwater. Typically, in Chapter 15 accident analyses control system action is considered only if that action results in more severe accident results. The feedwater and pressurizer control systems have a direct impact on the accident analysis assumptions and modeling.

Step 6:

In the Excess Feedwater accident analysis, the initial conditions already assume abnormally low pressure and/or DNBR. Since the pressurizer pressure control system would mitigate the results of the accident, no credit is taken for operation of the pressurizer pressure control system. Therefore, a malfunction of the control system would have no effect on this event and no effect on the safety analysis result.

The severity of the initiating failure is not affected due to the combination of the two control systems. The minimum allowed DNBR to satisfy the accident analysis acceptance limit is 1.30. The current minimum DNBR result is 1.42. After using an increased value for the new feedwater flow (to represent the increase in feedwater flow caused by the opening of the four feedwater flow control valves) and adjusting the appropriate inputs to reflect the new detrimental pressurizer heater and spray conditions in a revision to the Excess Feedwater accident analysis, the new minimum DNBR result is 1.33.

Conclusion With the software CCF likelihood determined to be not sufficiently low (i.e., a malfunction is as likely to happen as those described in the UFSAR),

the severity of the initiating failure has increased. The impairment of the pressurizer pressure control function is already incorporated in the safety analysis modeling. The new minimum DNBR result continues to satisfy the accident analysis acceptance limit, which does not change the result of the D-57

safety analysis. Therefore, the proposed activity does NOT create the possibility of a malfunction of an SSC important to safety with a different result.

Example 4-24 illustrates a case in which there is the CREATION of a malfunction with a different result.

Example 4-24. CREATION of a Malfunction with a Different Result Proposed Activity An upgrade to the analog-based reactor protection system with a digital-based reactor protection system is proposed. This proposed modification involves replacement of all the solid state cards that control the detection of anticipated operational occurrences and the actuation of the required reactor trip signals. Redundant channels contain these cards in satisfaction of single failure criteria.

Safety Analysis Result Impact Consideration Step 1:

The number of involved functions is large, all of which involve the detection of the occurrence of anticipated operational occurrences, the processing of those signals, and the generation of the appropriate reactor trip signals.

Step 2:

In this case, whether the functions are design bases function is not readily determined, so the associated GDCs will be identified and examined.

Criterion 20 -- Protection system functions. The protection system shall be designed (1) to initiate automatically the operation of appropriate systems including the reactivity control systems, to assure that specified acceptable fuel design limits are not exceeded as a result of anticipated operational occurrences and (2) to sense accident conditions and to initiate the operation of systems and components important to safety. [emphasis added]

Criterion 21 -- Protection system reliability and testability. The protection system shall be designed for high functional reliability and inservice testability commensurate with the safety functions to be performed. Redundancy and independence designed into the protection system shall be sufficient to assure that (1) no single failure results in loss of the protection function and (2) removal from service of any component or channel does not result in loss of the required minimum redundancy unless the acceptable reliability of operation of D-58

the protection system can be otherwise demonstrated. The protection system shall be designed to permit periodic testing of its functioning when the reactor is in operation, including a capability to test channels independently to determine failures and losses of redundancy that may have occurred. [emphasis added]

Criterion 22 -- Protection system independence. The protection system shall be designed to assure that the effects of natural phenomena, and of normal operating, maintenance, testing, and postulated accident conditions on redundant channels do not result in loss of the protection function, or shall be demonstrated to be acceptable on some other defined basis. Design techniques, such as functional diversity or diversity in component design and principles of operation, shall be used to the extent practical to prevent loss of the protection function. [emphasis added]

The components perform functions that support or impact design bases functions specified in GDCs 20, 21, and 22. Thus, these functions are design functions and are credited in the safety analysis.

Step 3:

The effect on the detection, processing and generation of signals is clear and understood, having a direct impact on the safety analysis assumptions. There is no reason to contemplate the generation of a new FMEA since the impact of the software CCF on the design bases functions is readily apparent (i.e., clear and understood).

Step 4:

Performance/satisfaction of the design bases functions related to the GDC 21 and 22 requirements regarding single failure criteria and redundant channels will not continue to be performed/satisfied.

Step 5:

Numerous safety analyses contain implicit assumptions regarding the performance and/or expectation of the minimum number of system/components and/or trains/channels that are expected to perform their function, which satisfy the applicable redundancy requirements and/or single failure criteria.

Step 6:

In all cases for each safety analysis, the inability to satisfy the performance and/or expectation of the minimum number of systems/components and/or trains/channels violates an assumption upon which the safety analysis results are based.

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In these instances, a simple review of the safety analyses and their structure will quickly identify that the results will exceed the associated acceptance criteria.

Conclusion With the software CCF likelihood determined to be not sufficiently low (i.e., a malfunction is as likely to happen as those described in the UFSAR),

the assumptions regarding satisfaction of single failure criteria are invalidated. Therefore, the proposed activity DOES create the possibility of a malfunction of an SSC important to safety with a different result.

HUMAN-SYSTEM INTERFACE ASSESSMENT If no personnel-based initiators involving degraded operator performance (e.g., operator error) are identified as malfunction initiators, then the creation of a possibility for a malfunction of an SCC important to safety with a different result cannot occur due to the Human-System Interface portion of the digital modification. Otherwise, the creation of a possibility for a malfunction of an SSC important to safety with a different result is assessed utilizing the guidance described in NEI 96-07, Section 4.3.6.

4.3.7 Does the Activity Result in a Design Basis Limit for a Fission Product Barrier Being Exceeded or Altered?

There is no unique guidance applicable to digital modifications for responding to this Evaluation question because the identification of possible design basis limits for fission product barriers and the process for determination of "exceeded" or "altered" are not unique for a digital modification. The guidance in NEI 96-07, Section 4.3.7 applies.

4.3.8 Does the Activity Result in a Departure from a Method of Evaluation Described in the UFSAR Used in Establishing the Design Bases or in the Safety Analyses?

There is no unique guidance applicable to digital modifications for responding to this Evaluation criterion because activities involving methods of evaluation do not involve SSCs. The guidance in NEI 96-07, Section 4.3.8 applies.

5.0 EXAMPLES

[LATER]

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NEI 96-07, Appendix D Draft Revision 0f Nuclear Energy Institute SUPPLEMENTAL GUIDANCE FOR APPLICATION OF 10 CFR 50.59 TO DIGITAL MODIFICATIONS July 2018

ACKNOWLEDGMENTS NEI would like to thank the NEI 01-01 Focus Team for developing this document.

Although everyone contributed to the development of this document, NEI would like to give special recognition to David Ramendick, who was instrumental in preparing this document.

NOTICE Neither NEI, nor any of its employees, members, supporting organizations, contractors, or consultants make any warranty, expressed or implied, or assume any legal responsibility for the accuracy or completeness of, or assume any liability for damages resulting from any use of, any information apparatus, methods, or process disclosed in this report or that such may not infringe privately owned rights.

EXECUTIVE

SUMMARY

NEI 96-07, Appendix D, Supplemental Guidance for Application of 10 CFR 50.59 to Digital Modifications, provides focused application of the 10 CFR 50.59 guidance contained in NEI 96-07, Revision 1, to activities involving digital modifications.

The main objective of this guidance is to provide all stakeholders a common framework and understanding of how to apply the 10 CFR 50.59 process to activities involving digital modifications.

The guidance in this appendix supersedes the 10 CFR 50.59-related guidance contained in NEI 01-01/ EPRI TR-102348, Guideline on Licensing of Digital Upgrades.

i

TABLE OF CONTENTS EXECUTIVE

SUMMARY

...................................................................................................................................... i 1 INTRODUCTION ........................................................................................................................................ 2

1.1 BACKGROUND

................................................................................................... 2 1.2 PURPOSE ........................................................................................................... 3 1.3 10 CFR 50.59 PROCESS

SUMMARY

.................................................................. 3 1.4 APPLICABILITY TO 10 CFR 72.48 ................................................................... 3 1.5 CONTENT OF THIS GUIDANCE DOCUMENT ..................................................... 3 2 DEFENSE IN DEPTH DESIGN PHILOSOPHY AND 10 CFR 50.59 ................................................ 3 3 DEFINITIONS AND APPLICABILITY OF TERMS ............................................................................... 4 4 IMPLEMENTATION GUIDANCE............................................................................................................. 5 4.1 APPLICABILITY ................................................................................................. 5 4.2 SCREENING ....................................................................................................... 5 4.3 EVALUATION PROCESS ................................................................................... 24 5.0 EXAMPLES ............................................................................................................................................... 63 D-1