ML21105A543

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Final Significance Determination of a White Finding with Assessment Follow-Up and Notice of Violation: NRC Inspection Report 05000333/2021090
ML21105A543
Person / Time
Site: FitzPatrick Constellation icon.png
Issue date: 04/20/2021
From: Ray Lorson
NRC Region 1
To: Rhoades D
Exelon Generation Co
References
EA-20-138, IR 2021090
Download: ML21105A543 (23)


See also: IR 05000333/2021090

Text

UNITED STATES

NUCLEAR REGULATORY COMMISSION

REGION I

2100 RENAISSANCE BOULEVARD, SUITE 100

KING OF PRUSSIA, PA 19406-2713

April 20, 2021

EA-20-138

Mr. David P. Rhoades

Senior Vice President

Exelon Generation Company, LLC

President and Chief Nuclear Officer, Exelon Nuclear

4300 Winfield Road

Warrenville, IL 60555

SUBJECT:

JAMES A. FITZPATRICK NUCLEAR POWER PLANT - FINAL SIGNIFICANCE

DETERMINATION OF A WHITE FINDING WITH ASSESSMENT FOLLOW-UP

AND NOTICE OF VIOLATION - NRC INSPECTION REPORT

05000333/2021090

Dear Mr. Rhoades:

This letter provides you the final significance determination for the preliminary White finding

discussed in the U.S. Nuclear Regulatory Commission (NRC) letter dated January 21, 2021,

which included NRC Inspection Report Number 05000333/2020012 (ML21020A108).1 The

finding, as initially described in the report, involved a failure by Exelon Generation Company,

LLC (ExGen) to control defective parts at the Limerick Generating Station (Limerick) and

prevent their subsequent use at the James A. FitzPatrick Nuclear Power Plant (FitzPatrick). As

described in the subject inspection report, the NRC determined that this finding involved

apparent violations of Title 10 of the Code of Federal Regulations (10 CFR) Part 50,

Appendix B, Criterion XV, Nonconforming Materials, Parts, or Components and Criterion VII,

Control of Purchased Material, Equipment, and Services. The receipt and use of the defective

part at FitzPatrick resulted in a failure of the High Pressure Coolant Injection (HPCI) system on

April 10, 2020. Consequently, ExGen also violated FitzPatrick Technical Specification (TS) 3.5.1, since the HPCI system was determined to be inoperable for greater than the TS

allowed outage time.

In a letter dated February 26, 2021 (ML21057A190), ExGens Mr. Pat Navin, FitzPatrick Site

Vice President, provided a written response that acknowledged the circumstances that led to

the use of the defective part at FitzPatrick. However, in the response, ExGen also:

(1) described Exelons business services group (which handled the part at Limerick and

FitzPatrick) as being a separate corporate entity that works only under the specific facility

license at which the staff are physically located and disagreed the Criterion XV violation

represented a failure that was within FitzPatricks ability to foresee and prevent; (2) maintained

that FitzPatricks receipt inspection of the parts was performed in accordance with Criterion VII

and other regulatory and self-imposed requirements; and (3) provided information and insights

related to the NRCs preliminary characterization of the finding as being of low-to-moderate

1 Designation in parentheses refers to an Agency-wide Documents Access and Management System

(ADAMS) accession number. Documents referenced in this letter are publicly-available using the

accession number in ADAMS.

D. Rhoades

2

(White) safety significance and stated that the significance of this finding could potentially be

below the threshold for a White determination.

In the February 26, 2021, letter, ExGen also indicated that the NRCs description of the

Criterion VII apparent violation should be analyzed as a backfit under 10 CFR Part 50.109,

Backfitting. On March 3, 2021, Mr. Daniel Collins, Director, Division of Reactor Projects and

Mr. Eric D. Miller, Senior Resident Inspector, of my staff participated in a telephone call with

ExGens Mr. Navin and Ms. Adriene Smith, FitzPatrick Director of Organizational Performance

and Regulatory Affairs, to obtain clarification on whether ExGen was requesting to enter the

backfit appeal process described in NRC Management Directive 8.4, Management of

Backfitting, Forward Fitting, Issue Finality, and Information Requests. Mr. Navin and Ms. Smith

clarified during the call that ExGen was not requesting to enter the backfit appeal process at this

time but may choose to formally contest the violations or seek formal review of backfit concerns

after the final significance determination is issued. Therefore, the NRC evaluated the remaining

items in ExGens February 26, 2021, letter. A summary of ExGens positions as provided in its

letter, the NRCs response to the points raised by ExGen, and the details of the NRCs

conclusion on the safety significance of this issue, are provided in Enclosure 1.

After careful consideration of the information developed during the inspection and the additional

information provided in ExGens February 26, 2021, letter, the NRC staff has clarified the finding

and has concluded that the finding is appropriately characterized as White, a finding of low to

moderate safety significance. The NRC staff has also determined that the finding involved

violations of 10 CFR Part 50, Appendix B, Criterion VII, Criterion XV, and TS 3.5.1, and has

revised those violations. Our considerations in reaching these determinations included that:

1) the duration of the finding and violations should be changed from 2010 to 2017 in order to

more clearly focus on the time period in which Fitzpatrick had become part of the ExGen Fleet;

2) the NRCs Enforcement Policy holds licensees accountable for the actions of their

employees, contractors and vendors, and, therefore, the information in ExGens response

regarding ExGens corporate structure and internal work practices (i.e. roles and responsibilities

of buyers and sellers) would not impact the assignment of this regulatory and enforcement

action to Fitzpatrick; and, 3) our review of the additional information provided relative to the risk

for this finding did not materially impact our assessment. In fact, a more comprehensive

analysis of some of the information provided may have actually resulted in an overall increase in

our risk assessment. It should be noted that the violations are strictly focused on compliance

with 10 CFR Part 50, Appendix B, but should not be viewed as limiting or impacting any of your

internal practices as long as the applicable underlying regulatory requirements are satisfied.

The revised finding is provided in Enclosure 2. You have 30 calendar days from the date of this

letter to appeal the NRC staffs determination of significance for the identified White finding.

Such appeals will be considered to have merit only if they meet the criteria given in the NRC

Inspection Manual Chapter 0609, Attachment 2, Process for Appealing NRC Characterization

of Inspection Findings (SDP Appeal Process), effective January 25, 2021. An appeal must be

sent in writing to the Regional Administrator, Region I, 2100 Renaissance Boulevard, Suite 100,

King of Prussia, PA 19406.

The revised violations are cited in the Notice of Violation (Notice), provided as Enclosure 3.

Because the violations are related, they have been categorized collectively as an enforcement

problem, which is a way of documenting violations that share a common factor (i.e., cause and

effect) rather than citing individually. By grouping such violations, the NRC applies appropriate

focus on the underlying factors that caused the concerns, so that licensees can develop

effective and comprehensive corrective actions.

D. Rhoades

3

In accordance with the NRC Enforcement Policy, the Notice is considered an escalated

enforcement action because it is associated with a White finding. You are required to respond

to this letter and should follow the instructions specified in the enclosed Notice when preparing

your response. If you have additional information that you believe the NRC should consider,

you may provide it in your response to the Notice. The NRC review of your response to the

Notice will also determine whether further enforcement action is necessary to ensure

compliance with regulatory requirements.

As a result of this White finding in the Mitigating Systems Cornerstone, the NRC has assessed

FitzPatrick to be in the Regulatory Response column of the NRCs Reactor Oversight Process

Action Matrix described in Inspection Manual Chapter 0305, Operating Reactor Assessment

Program, retroactive to the fourth calendar quarter of 2020. The NRC plans to conduct a

supplemental inspection for this finding in accordance with Inspection Procedure 95001,

Supplemental Inspection Response to Action Matrix Column 2 (Regulatory Response) Inputs,

effective January 1, 2021, following Exelons notification of readiness for this inspection. This

inspection is conducted to provide assurance that the root causes and contributing causes of

any performance issues are understood, the extent of condition is identified, and the corrective

actions are sufficient to prevent recurrence.

In accordance with 10 CFR 2.390 of the NRC's Rules of Practice and Procedure, a copy of this

letter, its enclosure, and your response will be made available electronically for public inspection

in the NRC Public Document Room or from the NRCs document system (ADAMS), accessible

from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible,

your response should not include any personal privacy, proprietary, or safeguards information

so that it can be made available to the Public without redaction.

Should you have any questions regarding this matter, please contact Ms. Erin E. Carfang, Chief,

Projects Branch 1, Division of Reactor Projects in Region I, at 610-337-5120.

Sincerely,

Raymond K. Lorson

Deputy Regional Administrator

Docket No.

50-333

License No.

DPR-59

Enclosures:

As stated

cc w/encl: Distribution via ListServ

Raymond K.

Lorson

Digitally signed by

Raymond K. Lorson

Date: 2021.04.20

14:07:45 -04'00'

ML21105A543

X

SUNSI Review/

X

Non-Sensitive

Sensitive

X

Publicly Available

Non-Publicly Available

OFFICE

RI/ORA

RI/DORS

RI/DORS

RI/DRSS

RI/ORA

RI/ ORA

NAME

M McLaughlin

E Miller via email

D. Collins via

email

P. Krohn via

email

B Klukan via email

R McKinley via email

DATE

3/26/21

4/3/21

4/6/21

3/31/21

3/31/21

4/2/21

OFFICE

RI/DORS

NRR

OE

RI/DRA

NAME

E Carfang via

email

R Felts via email

R Fretz via email

R Lorson

DATE

4/7/21

4/7/21

4/7/21

4/20/21

ENCLOSURE 1

NRC RESPONSE TO INFORMATION PROVIDED IN THE

EXGEN LETTER DATED FEBRUARY 26, 2021, REGARDING A

HIGH PRESSURE COOLANT INJECTION FINDING

As discussed below, the NRC staff reviewed the points raised by Exelon Generation Company,

LLC (ExGen) and determined that the proper characterization of the finding remains of

low--to--moderate safety significance (White). The NRC staff has also determined that the

finding involved violations of 10 CFR Part 50 Appendix B, Criterion VII, Criterion XV, and

TS 3.5.1.

However, the NRC staff has revised the finding and violations as described in Enclosures 2

and 3. Specifically, the NRC staff determined that: 1) the duration of the finding and violations

should be changed from 2010 to 2017 in order to more clearly focus on the time period in which

Fitzpatrick had become part of the ExGen Fleet; 2) the NRCs Enforcement Policy holds

licensees accountable for the actions of their employees, contractors and vendors , and,

therefore, the information in ExGens response regarding ExGens corporate structure and

internal work practices (i.e. roles and responsibilities of buyers and sellers) would not impact

the assignment of this regulatory and enforcement action to Fitzpatrick; and, 3) our review of the

additional information provided relative to the risk for this finding did not materially impact our

assessment. In fact, a more comprehensive analysis of some of the information provided may

have actually resulted in an overall increase in our risk assessment. It should be noted that the

violations are strictly focused on compliance with 10 CFR Part 50, Appendix B, but should not

be viewed as limiting or impacting any of your internal practices as long as the applicable

underlying regulatory requirements are satisfied.

SUMMARY OF EXGEN COMMENT - Independence of Licensed Facilities

ExGen stated that the James A. FitzPatrick Nuclear Power Plant (JAF) licensed facility and the

Limerick Generating Station (LIM) licensed facility are legally independent entities with separate

NRC-issued operating licenses that are supported by common resources as part of the

larger ExGen fleet. Support resources provided by the Exelon Business Services Company

(BSC) and which are assigned to individual licensed facilities are subject to the specific

operating license(s) of the facility to which they are assigned. Therefore, the ability to foresee

and prevent the deficiency at LIM (seller) in 2010 should not be a basis for the deficiency being

foreseeable and preventable by JAF (buyer) in 2017.

NRC RESPONSE

Although each facility maintains separate NRC operating licenses, the JAF License No. DPR-59

and the LIM License Nos. NPF-39 and NPF-85 each specify Exelon Generation Company, LLC

as the licensee. However, more salient to this issue is that, upon joining the ExGen fleet in

2017, JAF began to utilize and have access to many of the same processes and programs as

LIM and other ExGen sites, including the corrective action program and component tracking

database. The NRC identified that both of these programs contained information pertaining to

the defective high pressure coolant injection (HPCI) system oil pressure control valve (PCV).

The performance deficiency and apparent violations as originally presented in NRC inspection

report number 05000333/2020012 described in full the circumstances that led to the installation

of the defective PCV at JAF. This included describing the failures that occurred in 2010 at LIM

Enclosure 1

2

in response to a Title 10 of the Code of Federal Regulations (10 CFR) Part 21 notification when

staff at that site did not segregate or place an electronic hold on the PCV, contrary to Exelon

procedures. The NRC staff considered the comments in ExGens February 26, 2021, letter

pertaining to the finding and acknowledges that in 2017, ExGen staff could not have prevented

the process breakdown that occurred at LIM in 2010. However, the NRC staff maintains that it

was reasonable in 2017 for ExGen staff to have identified the information about the defective

component that was readily available in the component tracking database and corrective action

database; common ExGen programs utilized by both sites. For example, when receiving the

part, ExGen staff at JAF accessed the component tracking database and removed a 'hold' due

to a shelf life concern. The NRC staff identified that information about the Part 21 notification

was readily available in the database and could reasonably be identified by a qualified

procurement engineer when performing a review of available information to address the hold'.

Additional detail about the NRC staffs conclusions related to the finding is provided in the NRC

response to ExGens comment below related to the Criterion VII violation.

In light of these considerations, the NRC staff revised the finding and violations to properly focus

on the events that occurred in 2017. The circumstances of the 2010 failures are still included in

the Description Section of the finding as background information. The revised finding and

violations are provided as Enclosures 2 and 3 to this final determination report.

SUMMARY OF EXGEN COMMENT - 10 CFR Part 50, Appendix B, Criterion XV

The 10 CFR Part 50, Appendix B, Criterion XV violation and associated performance deficiency

occurred at the LIM licensed facility in 2010 by support resources working in direct support of

the LIM operating licenses. The Inspection Report identified an apparent violation of 10 CFR

Part 50, Appendix B, Criterion XV, "Nonconforming Materials, Parts, or Components" based on

the failure to properly identify and segregate non-conforming material that was identified and

communicated to LIM by a General Electric-Hitachi (GEH) 10 CFR Part 21 notification. The JAF

Causal Analysis to address the HPCI failure determined that as part of LIMs response to the

2010 GEH 10 CFR Part 21 notification, LIM personnel failed to follow procedure requirements to

place an electronic hold and segregate the defective part. This allowed the defective part to be

sold to JAF in 2017 without being notified of the deficiency.

NRC RESPONSE

As described above, the NRC staff acknowledges that prior to 2017, ExGen staff at JAF could

not have prevented the 2010 failures at LIM related to identifying and segregating the

non-conforming PCV since JAF was not transferred to ExGen until March 2017. Therefore, the

finding and the related Criterion XV violation have been revised accordingly. However, the NRC

staff maintains that the remaining aspect of the finding and Criterion XV violation is attributable

to JAF. Specifically, the regulation requires that licensees establish measures to control

materials, parts, or components which do not conform to requirements in order to prevent their

inadvertent use or installation and to accept, reject, repair, or rework nonconforming items.

Regardless of the past failures to identify and segregate the nonconforming PCV, in 2017

ExGen again did not control and reject the nonconforming component, resulting in its

acceptance and installation at JAF. The NRC staff maintains that JAF is responsible for this

failure.

In particular, the activities performed in 2017 to transfer the part between LIM and JAF and to

accept and use the part at JAF were performed in support of ExGen and the JAF license. As

Enclosure 1

3

noted in Section 1.2 of the NRC Enforcement Policy, it is NRC policy to hold licensees

responsible for the acts of their employees, contractors, or vendors and their employees, and

the NRC may cite the licensee for violations committed by its employees, contractors, or

vendors and their employees. Therefore, regardless of the physical locations of the involved

staff, their reporting authority under the greater Exelon Corporation structure, or the typical

responsibilities of these individuals to support the licensed facilities at which they are located,

when individuals are directed by a licensee to perform activities that affect that NRC licensee,

that licensee assumes the responsibility for violations caused by the individuals actions or

inactions.

Furthermore, the NRC staff maintains that, in consideration of the common procedures and

processes shared between LIM and JAF, it was reasonable for ExGen staff at JAF to have

foreseen and prevented the acceptance and use of the nonconforming PCV and that ExGen

staff at JAF should have identified and rejected the defective item during receipt inspection

activities conducted in December 2017. Additional information about the finding is provided in

the NRC response to ExGens comment below related to the Criterion VII violation.

SUMMARY OF EXGEN COMMENT - 10 CFR Part 50, Appendix B, Criterion VII

The receipt inspection completed at JAF in 2017 was performed consistent with the

requirements of 10 CFR Part 50, Appendix B, Criterion VII and the JAF Quality Assurance

Program (QAP) requirements and, therefore, does not constitute a failure to follow a regulatory

or self-imposed standard. The Inspection Report identified a Violation of 10 CFR Part 50,

Appendix B, Criterion VII, "Control of Purchased Material, Equipment, and Services based on

the failure to identify, during receipt inspection, that the purchased valve was the subject of a

2010 10 CFR Part 21 notification. ExGen has confirmed that the JAF receipt inspection was

performed consistent with the requirements of 10 CFR Part 50, Appendix B, Criterion VII and

the JAF QAP and, therefore, was not a failure to follow a regulatory or self-imposed standard.

Additionally, without further actions beyond these requirements, the receipt inspector could not

reasonably have been expected to identify that the valve was the subject of the 2010 10 CFR

Part 21 notification based on the documentation provided by the seller (LIM).

NRC RESPONSE

Title 10 CFR Part 50, Appendix B, Criterion VII requires that licensees establish measures to

assure that purchased material, equipment, and services, whether purchased directly or through

contractors and subcontractors, conform to procurement documents. However, the measures

implemented by ExGen in 2017 did not identify the nonconformance of the PCV. A licensees

QAP and the processes developed to implement that program provide the mechanism for the

licensee to comply with 10 CFR Part 50, Appendix B; they do not serve as replacements or

alternatives to these regulatory requirements. Therefore, if a licensees QAP, or implementation

of the QAP, fails to ensure that the licensee meets an Appendix B requirement, the licensee is

in violation of that requirement.

The NRC staff maintains that, in this case, the receipt inspection performed at JAF (the intended

measure to assure purchased material conformed to procurement documents) was not sufficient

to meet this Appendix B requirement. Specifically, as noted in the finding description in

Enclosure 2, the ExGen Quality Assurance Program Manual (QAPM), Revision 0, Section A,

Management, stated, the requirements and commitments contained in the QAPM are

mandatory and must be implemented, enforced, and adhered to by all individuals and

organizations. Section 5, Procurement Verification, required a program to be established and

Enclosure 1

4

implemented to verify the quality of purchased items and services. Section 6, Identification and

Control of Items, required a program to be established and implemented to identify and control

items to prevent the use of incorrect or defective items. The receipt inspection, conducted using

ExGen Procedure SM-AA-102, Revision 23, Warehouse Operations, implemented these

procurement verification requirements. This receipt inspection did not identify that the PCV

contained a defective diaphragm.

The NRC staff maintains that it was reasonably within ExGens ability to foresee and prevent the

use of the nonconforming PCV at JAF. In particular, information about the defective diaphragm

was located in both the ExGen component tracking database and corrective action database.

The inspectors reviewed the component tracking database and determined that the issue report

(IR) associated with the 10 CFR Part 21 report should have been reasonably identified by a

qualified procurement engineer. Notably, when receiving the part, ExGen staff at JAF accessed

the component tracking database and removed a 'hold' due to a shelf life concern. The NRC

staff identified that information about the Part 21 notification was readily available in the

database and could reasonably be identified by a qualified procurement engineer when

performing a review of available information to address the hold.' The staff also noted that the

information was available to staff involved with the transfer of the component to JAF through the

ExGen corrective action program, because the issue report was noted in the component

tracking database and had not been resolved at the time the part was moved to and accepted at

JAF. As such, it was reasonable for ExGen staff responsible for, and in control of, both sides of

the internal transaction that occurred in order to effect the movement of the PCV from LIM to

JAF in 2017 to have identified the Part 21 information related to the PCV.

SUMMARY OF EXGEN COMMENT - Uncertainties Input for Significance Determination

ExGen provided new information and additional insights which the licensee stated reduce some

of the calculational uncertainties that weigh into the Significance Determination (SDP). ExGen

indicated that the uncertainties are smaller than characterized in the NRC inspection report and

could potentially result in a significance below the threshold for a White determination.

1. The JAF Engineering staff has performed additional engineering reviews related to the

maximum oil leak rate from the HPCI system PCV which provide information supporting the

leak rate used in the JAF SDP analysis.

2. JAF Operations staff have gathered and documented additional timeline and performance

data which better characterizes the uncertainty in the analysis of operator credit for

identification and restoration of HPCI oil.

3. JAF Operations and Engineering staff have validated information regarding Main Control

Room (MCR) staff operation of HPCI during transient conditions.

4. JAF Engineering and Probabilistic Risk Assessment (PRA) Staff provided information

regarding incorporation of Electric Power Research Institute (EPRI) fire realisms and the

associated reduction in fire ignition frequencies (FIFs) for areas that are risk important

relative to HPCI operation.

NRC RESPONSE

The NRC staff reviewed the information in ExGens written response and determined that the

proper characterization of this finding overall remains of low-to-moderate safety significance

Enclosure 1

5

(White). The NRC staff agreed that ExGens use of revised fire ignition frequencies from those

used in the NRC risk determination was appropriate. However, the slight reduction in the

calculated increase in core damage frequency (CDF) due to a lower fire risk estimate did not

impact the overall NRC risk assessment and significance determination process conclusion.

The following details the NRCs assessment regarding the four areas of input provided by

ExGen for consideration in the SDP:

1. Calculated Maximum Oil Leak

NRC Response

ExGen utilized a slightly lower minimum leak rate of 0.19 gallons per minute (gpm) with a

maximum leak rate of 2.8 gpm, which considered higher operating oil temperatures when the

system would be in service. The NRC SDP analysis utilized a minimum leak rate of 0.28 gpm

with a maximum leak rate of 3.65 gpm to arrive at a weighted leak rate estimate which would

account for the probability of an early re-positioning of the degraded, nonconforming Part 21

pressure control valve (PCV). As stated in the detailed risk evaluation (DRE), the NRC used

industry data to estimate a probability that an early HPCI system trip would lead to a large leak

from the PCV. The early probabilistic trip of the HPCI system was determined to be 0.15

through several different methodologies as described within the DRE. However, the DRE

described how this number may be an underestimation of the actual data, even though used in

the development of the weighted leak rate estimation. It is not uncommon for the HPCI system

to be tripped early for level control during postulated events and a sample of industry data

reviewed, reflected that an early HPCI trip could occur up to 50 percent of the time based on a

review of a sample of Licensee Event Reports. This illustrates in part, the uncertainty with

evaluating what leak rate would have existed within this degraded part during a postulated event

where HPCI would have responded. The NRC noted in the DRE that the initial leak rate

subsequently identified by ExGen was reported as one pint in two minutes, although computer

information provided to the analysts indicated the pump was run with the PCV at normal

pressure for only one minute. Of further concern related to the accuracy of ExGens estimated

leak rate was the inconsistency between the leak rate assumed in the analysis and the initial

leak of 0.25 gpm leak rate that was verbally reported to the resident inspector staff. As a result,

the analyst determined that the leak rate values provided in the ExGen analysis and follow-up

letter were uncertain, underestimated the actual leak rate, and are not viewed as credible.

When ExGen attempted to quantify the leak rate through a second start of the auxiliary oil

pump, the pump was secured after 30 seconds based on a much larger leak rate that

overwhelmed the collection apparatus used to measure the oil quantity. The 1.3 gpm was

based on the captured oil for the 30 second run. The analysts noted that the second run was

once again performed with the auxiliary oil pump (AOP), which develops a lower pressure

(85-95 psig) than if the shaft driven oil pump (SDOP) was started (105-110 psig) during an

actual run. The output of the controlling pump pressure is controlled by a main oil system PCV,

which will control downstream pressure to 38 psig. However, there is some response time by

the main PCV resulting in a slightly higher pressure pulse (i.e. stress) that was expected to have

been absorbed by the downstream nonconforming PCV diaphragm. This further adds to the

uncertainty, and validity of any measured oil leak when it was performed under non-operating

conditions. Actual turbine operating conditions result in different dynamics relative to the oil

system, with the potential for an even larger tear on the weakened nonconforming pressure

control valve diaphragm.

Enclosure 1

6

Notwithstanding the multitude of uncertainties mentioned above, if the NRC were to adjust their

weighted leak rate estimate by using a maximum leakage capped at 2.8 gpm or even slightly

lower as suggested by ExGen, this would have an inconsequential effect on the amount of time

assumed and calculated within the NRC DRE before the SDOP and AOP would lose suction

due to the loss of oil inventory. The NRC determined the information provided by ExGen would

have no substantive impact in this area, as the uncertainties overwhelm the ExGens

engineering analysis, including the inputs used in that analysis, for the calculated maximum oil

leak rate.

2. Oil Leak Mitigation/Credited Operator Actions

ExGens position is that giving no credit for operators to recover the HPCI system in the event of

an oil leak does not recognize proceduralized actions that the operators would take and be

capable of executing. ExGen contends that operating procedure, OP-15, Revision 68,

Section G.10, Adding Oil to HPCI Sump with HPCI in Service, provides explicit guidance to

maintain oil in the running level band. ExGen states that operators performed a timed

walkdown for recovery actions to maintain adequate oil level in the HPCI sump in the event the

HPCI PCV diaphragm had a tear. The walkdown was reported to result in operators

successfully restoring oil in approximately 27.5 minutes. ExGen stated that with regards to the

time until the leak is located, there are several considerations. OP-AA-103-102, Watch-

Standing Practices outlines expectations for non-licensed operators to monitor all equipment

they are responsible for. This procedure also establishes post-start and post-shutdown system

walk down requirements to ensure expected system and components response. Lastly, ExGen

stated that if the control room received the HPCI Turbine Bearing Oil Pressure Low annunciator

and HPCI operation is required, the main control room (MCR) operators would respond as

follows:

1. If the HPCI Auxiliary Oil Pump did not auto-start, then attempt to manually start the

pump from the control room.

2. If the annunciator does not clear, then send an operator locally to investigate the reason

for the loss of oil pressure.

3. The field operator would observe a large amount of oil at the HPCI skid and check HPCI

oil sump level.

4. Operations would perform actions per OP-15, Section F Shutdown to secure the AOP

when the HPCI turbine is not rotating.

5. The control room would direct the field operator to add oil to the HPCI sump.

ExGens position is that the oil leak can be effectively managed with readily available equipment

and procedurally directed operator actions.

NRC Response

ExGen procured a Vendor Report, EC-631895, Technical Evaluation to Support Availability of

HPCI System Due to Oil Leak in PCV-12, dated June 18, 2020, which was developed

regarding the oil leak and determined that there is a nominal 1-inch drop in the oil sump for

every 13 gallons of oil. During the postulated events evaluated in an SDP such as this, there

are multiple assumed failures of various equipment that lead to a path of core damage. For

Enclosure 1

7

these events, various equipment may be automatically started from emergency diesel

generators to the reactor core isolation cooling system (RCIC), HPCI, and a multitude of other

equipment. Thus, there can be a multitude of potential response areas required for plant

operators, which directly affects their response time. As noted in the calculation of the

maximum oil leak section above, a probabilistic leak rate could be in the area of 0.7 gpm to an

assumed maximum leakrate in the area of 2.8 gpm or higher, depending on the heatup rate of

the oil and any other factors which would have contributed to the PCV diaphragm tear. As

noted above, a plant operator may enter the HPCI cubicle and check the oil standpipe and with

various potential oil leak rates possible, the indicated level would likely be well within the sight

glass, with zero other operational abnormalities occurring or noticeable, including HPCI turbine

and pump bearing temperatures. This PCV is not located in the front of the machine and

depending on when an operator would check the machine, this leak may not be identified.

The NRC noted that the design of the HPCI control oil system at FitzPatrick does not have a

sump low-level alarm. Additionally, during a leak, it is apparent that other critical early cues of

higher bearing temperatures, low oil pressures, and low sump level would not be available

through instrumentation and would not provide ensured identification of a notable leak prior to

complete failure of the system to operate. Additionally, the assumed leak rate in this SDP

evaluation has unquantifiable uncertainties as mentioned above, with the potential to have been

larger than measured in the relatively colder non-turbine operating condition when the tear was

initially generated. The sequence of events per this design and nonconforming PCV, would be

a continued leak at an uncertain rate, with a silent effect on the system, the controls, and the

annunciators, as there would be no abnormalities until the system would terminate operation

due to complete suction loss of the shaft-driven oil pump (SDOP). As noted above, the only

alarm or cue would be the turbine bearing oil pressure, which would likely not annunciate even

with a large leak, due to a controlling PCV maintaining 38 psig upstream, which would serve to

compensate for the degraded PCV diaphragm leak, and continue to provide downstream flow

and pressure to the bearings.

The first absolute automatic cue for the operators would be this alarm, but it appears, per the

design, that it would come in after the SDOP would lose its suction prime due to low oil level,

resulting in a loss of discharge pressure. This would drop pressure to the control valve actuator

rotating gear pump and result in closure of the control steam valves as well as the turbine stop

valve. The SDOP will then spin down, with the main auxiliary oil pump (AOP) starting on low oil

pressure at around 35 psig. A further uncertainty is the AOP will start and run with no suction

head, likely cavitating as it continues to run without an adequate oil supply. As noted above, the

operators would actually be instructed to start the AOP if it didnt auto start even with an

inadequate suction pressure. When an operator would arrive in the area, there would be 60 to

65 gallons or more of hot oil within the skid area. There would be no leak visible or identifiable,

because the nonconforming PCV would have closed on loss of pressure and there would be no

pressure to drive any further leakage.

In this condition, it would not be obvious if there had been a pipe crack, a severe crack in the

various control oil piping and fittings, or complete failure of the oil system, and its likely

operators would be challenged to identify where the oil came from with 120 degree oil

potentially scattered within the skid area. Furthermore, there is another uncertainty with how

long the AOP would have been running, as it does not automatically receive a trip signal,

resulting in cavitation without any oil supply and/or if it would have damaged itself. ExGen

states they would enter section G.10, Adding Oil to HPCI Oil Sump with HPCI in Service. With

this scenario, however, HPCI would not be in-service as it would be secured automatically

(steam valves closed) due to the failure, contrary to the procedure entry definition/description.

Enclosure 1

8

OP-15, G.10, as written is intended to gather pre-filtered oil and if not prefiltered, to obtain an oil

filtration device and extension cord and fill an oil transfer container from labeled oil barrels in the

lube oil storage room per engineering direction. Again, it should be noted, it is very likely the

leak source would be difficult to determine at this point. Additionally, hooking up a funnel to a

leak source appears to not be proceduralized and the placement would not even be recognized

in this scenario, not to mention the effects of running the oil system below the AOP suction

capability, with air entrainment or other kinds of potential adverse effects on the AOP and motor.

Lastly, if recovery of HPCI in this situation became a priority as suggested in ExGens response,

an operator would have to fill the sump by finding a portable pump along with electricity for

said pump (i.e. for LOOP scenarios there likely isnt normal outlet power), then keep-up with

the potential large leak rate while looking for the leak point. Then, once the leak point is

identified, the operator needs to build the apparatus to route the leak to the sump. Additionally,

a recovery event such as this includes a human error probability (HEP) assessment which

would need to be analyzed on how it may affect the most dominating basic event in this risk

analysis (failure to depressurize event). This scenario will take cognitive ability to detect what

happened, make decisions and to understand the success path to restore the high pressure

system, including its recovery feasibility. In core damage scenarios or cutsets, this HPCI

recovery event would be accompanied by the SPAR model depressurization basic event

(ADS-XHE-XM-MDEPR). This event would now likely justify including a diagnosis as well as an

action assessment due to the cognitive nature of understanding and deciding if the operator

could restore a high pressure injection source in time while reactor vessel level is lowering,

while waiting until EOPs direct depressurization with the potential thought that HPCI is close to

being brought back to service. Adding this diagnostic piece to the normal depressurization

event in the SPAR model raises the potential for a higher failure probability by almost an order

of magnitude even considering extra time for diagnosis and action to depressurize in the

SPAR-H calculation. Therefore, by including a HPCI recovery event, the failure to depressurize

event could now be considered for increased failure probability due to the diagnosis needed in

this situation. A rough calculation has shown that this can increase one of the dominating

postulated core damage event scenarios such as a loss-of-condenser-heat sink for a 38-day

exposure (DRE risk of 4E-7/yr) to an increased risk of 2E-6/yr for this one event.

In summary, recovery credit including the challenges accompanying this condition, should likely

be considered for an increased failure in the ADS-XHE-XM-MDEPR basic event, which may

have a significant increase in the end result of the previous risk determination and make the

effects of recovery credit a non-substantive issue relative to lowering the calculated increase in

CDF/yr for this event.

Notwithstanding this, based on the above uncertainties, the lack of cues within the system

design, the uncertainties with the leak rate, the uncertainty with the timing and ability to detect

the leak through a walkdown post event for many systems, operator recovery was determined

not to be a feasible action in the primary base case evaluation of the condition, and the

information provided has no substantive effect on that conclusion. However, as is always

prudent, the NRC analysts performed a sensitivity study using appropriate considerations of

recovery difficulty in the DRE (Cases 3 and 4, used 1 out of 5 recovery) within the report giving

some credit for recovery. This sensitivity did not account for an evaluation of increasing the

failure to depressurize (basic event) through the model. If this became a base assumption the

SRA believes it would be appropriate to re-analyze for the above consideration which would

likely result in a notable overall increase of the calculated CDF for the HPCI PCV failure.

Enclosure 1

9

3. HPCI Operations During Transient Conditions

ExGen has stated that while operating HPCI with drywell pressure greater than 2.7 psig, the full

flow path test return valves close to divert all flow to the Reactor Pressure Vessel (RPV). To

control RPV water level, the main control room (MCR) operators would dial the flow controller

back as needed to control the injection rate and maintain level within the required bands

established in the station Emergency Operating Procedures (EOPs).

ExGen also acknowledged that running the HPCI pump on minimum flow with the full-flow test

return valves closed, is not preferred for long term reliability. However, in response to transient

and accident conditions, operations in this manner is consistent with guidance in station EOPs

by ensuring the HPCI system remains available as a high-pressure water source. As such,

MCR operators would not secure HPCI if it was running on minimum flow nor would the pump

be damaged during a transient or accident response to the point that sufficient flow could not be

developed.

NRC response

The NRC acknowledges that the station EOPs direct level control within the proper bands, using

any systems that may be available. The NRC also recognizes the difficulty with controlling level

using HPCI for various events. This is illustrated in the Fitzpatrick RCIC System, B 3.5.3,

technical specification basis document referring to Actions A.1 and A.2. The Bases states for

transients and certain abnormal events (i.e. which drive the NRCs risk SDP evaluation), with no

loss-of-coolant-accident, RCIC (as opposed to HPCI) is the preferred source of makeup coolant

because of its relatively small capacity, which allows easier control of the RPV water level.

Thus, there is a limited time allowed to restore RCIC to an operable status. This simply

confirms the challenge of operating HPCI under conditions where there may be lower makeup

requirements.

OP-15, Revision 68, High Pressure Coolant Injection, System Description, describes the

design operating conditions for when pump discharge water flows through the feedwater line

into the RPV, that HPCI will continue to inject 4250 gpm until RPV water level reaches

222.5 inches, then HPCI will trip on high RPV water level. If RPV water level lowers to

126.5 inches, HPCI will auto-initiate following a high RPV water level trip. This simply explains

the automatic design of the system where it is designed to continually, with no operator action,

inject, trip and reset as required. However, the NRC understands that this is not the preferred

operation or response as operators are trained and instructed to control RPV level within the

proper station EOP designated band without allowing HPCI trips; this description from OP-15

simply illustrates the design of the system.

As documented in the NRC SDP evaluation, while we have found no restriction within the

Fitzpatrick operating procedures specific to HPCI operating in the minimum flow mode taking

water from the condensate storage tank and depleting it to the torus, there are some

uncertainties with this operating mode (i.e., low flow only available). Specifically, there are Terry

Turbine Maintenance guides and technical reports/industry guidance applicable to HPCI, which

recognize that the design basis is to deliver constant flowrate to the RPV over a wide range of

reactor pressures. If reduced vessel injection flowrate (i.e., match decay heat for non-LOCA

transients), is required to control level, this is an off-design operation and is time-consuming and

requires operator attention to control. The pump head versus flow characteristics are relatively

flat as flowrate decreases below rated volume and it is recognized that reduced flowrates below

a nominal 75 percent below design, will likely cause system instability within the control system.

Enclosure 1

10

Additionally, typical Terry turbine guidance cautions that the pump/turbine controls should not

be operated less than 50 percent of rated flow for a sustained period of time. Further guidance

states that operating at 10 to 20 percent minimum flow is intended for startup and shutdown

only and severe internal cavitation at high head conditions can result in pump damage.

According to ExGens above statement, operators would not secure HPCI in the minimum flow

mode and therefore may have run the pump in this off-normal condition for long periods of time

in postulated events. There are several uncertainties with the definitive nature of this statement.

First, OP-15, Attachment 4, HPCI AUTO INITIATION VERIFICATION and SUBSEQUENT

ACTIONS, recognizes appropriately, that when operation of HPCI below 3000 gpm is required,

monitoring of the system operation frequently is required to ensure proper operation and if

oscillations occur then the system is to be operated with the controller in manual. The NRC

recognizes that if oscillations occur, the flow controller will result in increasing and decreasing

speed changes. This by itself would create the need for the main PCV within the oil system to

respond to control to 38 psig with changes in the SDOP speed. Any small delays in PCV

response could result in pressure changes and or small stress changes to the downstream

degraded PCV diaphragm. Additionally, OP-15, Attachment 6, HPCI Operation Flowchart,

requires verifying HPCI parameters per Section D of OP-15. These parameters include

monitoring outboard-end and pump-end vibration levels to ensure less than 0.385 inches per

second.

Because this operation may occur for extensive time periods through a mission time up to

15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />, long periods of HPCI operation can be expected in this condition. The HPCI system

is not normally run for long periods on minimum flow and hence there likely is no data available

on system effects. Therefore, an additional uncertainty would be if this mode of operation (long

term minimum flow operation) would challenge the procedures acceptable pump vibration

levels with the expected cavitation with the pump internals. If vibration levels would be

exceeded, this would be a decision point with regard to operation of the system (i.e. should the

system be used to fill to the EOP level zone at higher rates, then secured and restarted when

boil-off reduced level back to the lower end of the control zone). It is also unknown how internal

pump cavitation may affect the HPCI skid itself and if there could be any adverse effects on

resonance vibration on the nonconforming degraded PCV diaphragm condition through the

mission time, while running in this off-normal condition. It should be noted if there would be an

adverse effect on the nonconforming PCV; this could extend the exposure time going

backwards, factoring in all of the uncertainties mentioned above.

In addition, the DRE documented the basis for the 0.15 trip rate of the turbine based on industry

operating data, which is relevant to the expected operator responses for operation of the HPCI

turbine.

In summary, the statement concluding the operators would stay on minimum flow has

uncertainty with the ability to do that, considering the system is designed for much higher

flowrates per its design. Lastly, extended operation on minimum flow will deplete the preferred

condensate storage tank (CST) suction source to the torus, resulting in additional challenges of

CST source availability for the longer- term mission and also on control rod drive pump

capability as the CST is depleted for certain events. Because of the above uncertainties, the

NRC SDP used an exposure time above 38 days (i.e., 59 days) for only a very few applicable

events.

Notwithstanding the many uncertainties identified above with the definitive statements of not

securing HPCI if operating on extended minimum flow conditions, the NRC in response to this

Enclosure 1

11

letter and statement of expected operations, revised the 59-day exposure times for the

events to 38 days to determine its impact on the SDP. The result was there was an

inconsequential difference for the few events where the longer exposure time was used and

the final determination of a low to moderate risk significant issue remained unchanged.

4. Fire Analysis

The JAF PRA staff developed and used updated fire modeling ignition frequencies for the fire

areas reviewed in the NRC SDP analysis. The NRC analysis had used fire scenario

frequencies listed in the Fitzpatrick Fire PRA notebook at the time of the evaluation

(JF-PRA-021.11 James A. FitzPatrick - Fire Probabilistic Risk Analysis Summary &

Quantitative Notebook, Revision 2). ExGens position is that the fire ignition frequencies in the

JAF analysis should be used because they are based on more realistic fire modeling

frequencies.

NRC response

The NRC concurs that the JAF updated fire frequencies would result in smaller frequencies and

reduction in the NRC fire model risk assessment. The SPAR Delta CDF increase was

calculated to be 9.9E-7/yr. Using the revised frequencies, the Delta CDF in Table 2 of ExGens

letter resulted in a total of 5.6E-7/yr risk increase. It should be noted fire risk was not a

dominant contributor to this risk assessment.

NRC Overall Risk Determination Conclusion

The NRC does not believe the information and analysis presented by ExGen is substantive in its

nature in reducing the uncertainties and/or influencing a change in the final determination of

significance below the threshold for a White determination, in part, for the various reasons

mentioned above.

However, the NRC analysts reviewed all the information presented by ExGen in their

February 26, 2021 letter and performed a final sensitivity using all the suggested considerations

provided by ExGens supporting information.

The NRC analysts final sensitivity revised the exposure times from 59 days to 38 days based

on the potential for survival of HPCI remaining on minimum flow and never being tripped or

secured during the course of mission times up to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. The NRC analysts used the HPCI

recovery credit (0.8) as documented in the original DRE, however it should be noted this was

not the base case and they did not evaluate the effect this could have or potential increase on

the dominant basic event, (failure to depressurize), as mentioned above in the recovery section.

Finally, the analysts used the lower fire risk increase presented by ExGen. With all these

sensitivity changes, the increase in risk for internal events, flooding, fire and seismic resulted in

a revised conditional increase in CDF/yr of a nominal 2E-6/yr. It should be noted these changes

were only performed as a sensitivity as the NRC determined the information presented had no

substantive effect on the risk outcome (i.e., 3E-6/yr) and did not change the original SRA PRA

modeling assumptions, except for the fire ignition frequencies used. All other PRA modeling

assumptions have been documented and justified within the existing DRE.

Although some of the information provided within this letter may suggest there could be a

potential for an increase in risk over that which was originally calculated, the analysts believed

Enclosure 1

12

the original estimate remains a valid best-estimate given the information and uncertainties

relevant to this issue.

RISK SUMMARY

In summary, the NRC staff carefully reviewed the responses provided by ExGen. The NRC

staff acknowledges and considered ExGens viewpoint, but ultimately determined that the new

information did not alter the NRCs original risk assessment outcome or methodology as

described in Inspection Report 05000333/2020012, dated January 21, 2021 (ADAMS Accession

Number: ML21020A108). Based upon the additional information provided, the NRC staff

concluded that the finding remains appropriately characterized as White.

ENCLOSURE 2

REVISED FINDING

Defective Part Results in High Pressure Coolant Injection System Pressure Control Valve

Failure

Cornerstone

Significance

Cross-Cutting Aspect

Report Section

Mitigating Systems

White NOV

05000333/

2020012-01

Open

EA-20-138

[H.1] - Resources

71153

The inspectors documented a self-revealed White finding and related violations of Title 10 of

the Code of Federal Regulations (10 CFR) Part 50, Appendix B, Criterion VII, Control of

Purchased Material, Equipment, and Services, and Criterion XV, Nonconforming Materials,

Parts, or Components, because Exelon Generation, LLC (ExGen) did not adhere to

requirements to ensure that a high pressure coolant injection (HPCI) system oil pressure

control valve (PCV) conformed to all procurement requirements. Consequently, ExGen did

not reject the defective PCV, as identified in a 10 CFR Part 21 notification. As a result,

ExGen accepted and installed the part at FitzPatrick on December 16, 2017. The HPCI

system was subsequently declared inoperable on April 10, 2020, during a planned

surveillance test due to the defect identified in the Part 21 notification. This also caused the

HPCI system to be inoperable for greater than its technical specification allowed outage time

in accordance with NRC reportability guidelines.

Description: The HPCI system at FitzPatrick provides an emergency source of water

following a transient or accident. This high pressure source of coolant is delivered from two

water sources using steam generated from the reactor to drive the associated turbine and

pump. The HPCI system pump can deliver up to 4,250 gallons per minute and may be

operated across a wide range of reactor pressures. The HPCI system pump and turbine are

supported by an oil system designed to lubricate bearings and provide adequate pressure to

control the steam turbine stop and control valves.

On November 7, 2017, the NRC issued Order NRC-2017-0177 establishing Exelon

Generation, LLC (ExGen) as the owner, operator, and holder of the FitzPatrick Renewed

Facility Operating License No. DPR-59. ExGen owns or co-owns and operates 22 nuclear

reactors at 13 sites in four states. As stated, in part, in the application dated August 18, 2016

(ML16235A081), and approved by NRC Order NRC-2017-0177, ExGen provided that:

integration of the operation of FitzPatrick with Exelon Generations

current fleet of nuclear power plants, will allow consolidated operations of

FitzPatrick and the other nuclear units operated by Exelon Generation.

The seamless integration of FitzPatrick into Exelon Generations

operations will create a single organization with responsibility over all of

the plants for which it is the licensed operator.

Exelon Corporation, the parent company of ExGen, also operates a central supply

organization (Business Services Company, LLC (BSC)) that provides support for day-to-day

nuclear station (site) operations with a dual reporting relationship to the centralized supply

organization and the site organization. ExGen implements a fleet-wide quality assurance

program, along with procurement and warehouse procedures for all its associated nuclear

Enclosure 2

2

stations to verify, store, and move components between stations using BSC personnel. Once

accepted within the ExGen Quality Management System, a component can be installed at the

site of receipt, or moved and installed at another facility.

On December 11, 2008, ExGen received, inspected, and accepted a HPCI oil pressure

control valve, stock code 11466532. On July 1, 2010, ExGen was notified of a defective part

when General Electric-Hitachi issued MFN 10-192 (ML101820160), Part 21 Reportable

Condition Notification: Failure of HPCI Turbine Overspeed Reset Control Valve

Diaphragm. The Part 21 identified a vulnerability associated with the HPCI system oil PCV

actuator diaphragm due to a manufacturing error. This error resulted in inadequate fabric

reinforcement that is critical to ensure durability and reliability of the diaphragm, preventing

tearing of the diaphragm when used in the HPCI turbine lube oil system turbine trip and reset

valves (PCVs). The failure of the HPCI system PCVs diaphragm results in a loss of HPCI

system turbine lubricating and control oil through the failed diaphragm. According to the

Part 21 notification, depending on the amount of oil lost and the system demands, this loss

could ultimately result in a failure of the HPCI system. ExGen engineering staff entered

issue report (IR) 1086768 into their corrective action program and assigned actions including

direction to BSC staff to address the Part 21.

Exelon procedure SM-AA-102, Warehouse Operations, Revision 14, Attachment 3,

Section 1.5.2 required, Items found to be of suspect quality or deficient (e.g., items identified

externally via 10 CFR Part 21 defect reporting or items identified internally by maintenance)

shall be:

1. Placed on Hold status electronically to prevent allocation and inadvertent issue. In

Passport this may require the item to be issued from stock, then returned, moved from

[pending] to [hold] status.

2. Physically segregated from acceptable items with the same Catalog ID/Stock Code.

BSC staff working for ExGen at Limerick identified a PCV subject to the Part 21 notification at

the Limerick facility, but did not segregate or place an electronic hold on the PCV in their

component tracking database to prevent PCV installation with the defective diaphragm as

required by internal procedures following the July 1, 2010, Part 21 notification. BSC staff

documented the nonconformance in the component tracking database which referenced

IR 1086768. However, procedure SM-AA-102 did not include a standard method to

document Part 21 deficiencies within the component tracking database. Instead, there were

several options for documenting a Part 21 notification within this system, and ExGen relied on

skill of the craft for determining how to implement the procedural requirement.

On November 19, 2010, SM-AA-102 was revised to require, conspicuous signage that

shows these items are on hold, in addition to the electronic hold and physical separation.

However, BSC staff at Limerick did not use conspicuous signage on the PCV.

On December 16, 2017, ExGen issued purchase order (P.O.) 637326 to move the HPCI

system PCV from the Limerick warehouse to FitzPatrick during a planned HPCI system

maintenance window. During a HPCI maintenance window in December 2017, ExGen

replaced the HPCI PCV diaphragm and spring as part of preventive maintenance. Following

maintenance, ExGen was unsuccessful at restoring HPCI due to inadequate pressures in the

oil system. ExGen did not have a replacement PCV on site at the time, and subsequently

located the subject PCV at Limerick.

Enclosure 2

3

To effect the movement of the part, BSC staff at Limerick and FitzPatrick followed the

process prescribed in the ExGen Quality Assurance Program Manual (QAPM),

Revision 0. QAPM Section A, Management, stated, the requirements and commitments

contained in the QAPM are mandatory and must be implemented, enforced, and adhered to

by all individuals and organizations. QAPM, Section 5, Procurement Verification, required

that, a program is established and implemented to verify the quality of purchased items and

services at intervals and to a depth consistent with the item's or service's importance to

safety, complexity, and quantity and the frequency of procurement. QAPM, Section 6,

Identification and Control of Items, required a program to be established and implemented

to identify and control items to prevent the use of incorrect or defective items.

The inspectors determined that, in spite of utilizing the above process, staff involved with

transferring the HPCI PCV and inspecting and accepting it at FitzPatrick did not identify the

nonconformance, even though the information was readily available in both the ExGen

component tracking database and corrective action database. The defective valve was

accepted using a Product Quality Certificate dated December 12, 2008. This Product Quality

Certificate was invalidated by the July 1, 2010 Part 21 notification. The PCV was

subsequently installed in the FitzPatrick HPCI system during the maintenance window on

December 16, 2017.

Staff involved with transferring the HPCI PCV and inspecting and accepting it at FitzPatrick

reasonably had access to information about the nonconformance through at least two

means. First, to receive the part at FitzPatrick, BSC staff at FitzPatrick accessed the

component tracking database and removed a 'hold' due to a shelf life concern. The

inspectors reviewed the component tracking database and identified that information on

IR 1086768, the IR associated with the 10 CFR Part 21 notification, was present in the

database and could reasonably be identified by a qualified procurement engineer when

performing a review of available information to address the hold'. Second, the Part 21

information was available to the staff through the ExGen corrective action program, as

IR 1086768 was noted in the component tracking database. The IR had not been resolved at

the time the part was moved to and accepted at FitzPatrick, and this information would have

been available to any staff involved with this activity.

As a result of the defective part installation, on April 10, 2020, at 1:15 AM, while conducting

monthly technical specification surveillance testing of the HPCI auxiliary oil system, operators

identified an oil leak on pressure control valve (PCV), 23PCV-12. The auxiliary oil pump was

secured and the HPCI system was still considered operable by ExGen staff. Operators were

not able to definitively quantify the initial leak. At 3:00 AM, a second start of the auxiliary oil

pump was attempted to quantify the leak. During the second run, operators estimated the

leak to be 1.3 gpm. Thus, the HPCI system was declared inoperable and placed the station

into a higher licensee-established risk category (Yellow). ExGen notified the NRC of the

inoperability per 10 CFR Part 50.72(b)(3)(v)(D) via Event Notification 54647. The 23PCV-12

valve was replaced and the HPCI system restored to operable status on April 10, 2020,

at 8:02 PM.

Corrective Actions: ExGen performed immediate corrective actions to replace the defective

HPCI system PCV. ExGen also performed a fleet-wide stand down for procurement staff

to conduct additional training. Additionally, ExGen created a separate action for each ExGen

site to validate that a similar condition does not exist regarding dispositioning Part 21

components with inaccurate codes in their parts tracking database. Furthermore, ExGen

Enclosure 2

4

revised its warehouse and procurement procedures, adding steps pertaining to items subject

to 10 CFR Part 21 notifications and items with holds.

Corrective Action References: IR 4334315, IR 4348906

Performance Assessment:

Performance Deficiency: The inspectors determined that ExGen failed to ensure that

purchased material conformed to all procurement requirements and to reject a nonconforming

item and prevent its installation and use as required by 10 CFR Part 50, Appendix B, Criterion

VII, Control of Purchased Material, Equipment, and Services, and Criterion XV, Non-

conforming Materials, Parts, and Components, which was within their ability to foresee and

prevent.

ExGen implemented the requirements of 10 CFR Part 50, Appendix B using the Quality

Assurance Program Manual (QAPM), Revision 0 in 2017. Section A, Management, stated,

the requirements and commitments contained in the QAPM are mandatory and must be

implemented, enforced, and adhered to by all individuals and organizations. Section 5,

Procurement Verification, required a program to be established and implemented to verify

the quality of purchased items and services. Section 6, Identification and Control of Items,

required a program to be established and implemented to identify and control items to

prevent the use of incorrect or defective items. Procedure SM-AA-102 implemented these

procurement verification requirements.

On December 16, 2017, ExGen failed to verify that the PCV conformed to procurement

documents and did not identify that the PCV was nonconforming. Consequently, the PCV

containing the defective diaphragm was not rejected and was, instead, accepted using a

Product Quality Certificate dated December 9, 2008, which was subsequently invalidated by

the Part 21 notification issued July 1, 2010. The PCV was installed at FitzPatrick on

December 16, 2017 and failed on April 10, 2020.

Screening: The inspectors determined the performance deficiency was more than minor

because it was associated with the Equipment Performance attribute of the Mitigating

Systems cornerstone and adversely affected the cornerstone objective to ensure the

availability, reliability, and capability of systems that respond to initiating events to prevent

undesirable consequences. Specifically, the HPCI system was unavailable to perform its

safety function as a result of the failed PCV.

Significance: The inspectors assessed the significance of the finding using Appendix A, The

Significance Determination Process (SDP) for Findings At-Power. The inspectors reviewed

Inspection Manual Chapter (IMC) 0609, Attachment 4, Initial Characterization of Findings,

and determined the finding affects the mitigating system cornerstone. The inspectors

evaluated the significance of this finding using Inspection Manual Chapter (IMC) 0609,

Appendix A, The Significance Determination Process (SDP) for Findings at Power, Exhibit 2

- Mitigating Systems Screening Questions. The inspectors determined that the finding

represented a loss of the PRA function of a single train, the HPCI system, for greater than its

technical specification (TS) allowed outage time and required a detailed risk evaluation

(DRE).

A Region I Senior Reactor Analyst (SRA) performed a detailed risk evaluation. The finding

was determined to be of low to moderate safety significance (White). The risk important core

damage sequences were dominated by internal events, primarily loss of condenser heat sink

Enclosure 2

5

and loss of main feedwater. The dominant core damage sequence is loss of condenser heat

sink, failure of high-pressure injection (HPI), and failure to manually depressurize the

reactor. See Enclosure 1 to this final determination report and the Attachment, HPCI Oil

PCV Failure Detailed Risk Evaluation, to the preliminary determination report (ADAMS

Accession Number: ML21020A108) for a detailed review of the quantitative and qualitative

criteria considered in the final risk determination.

Cross-Cutting Aspect: H.1 - Resources: Leaders ensure that personnel, equipment,

procedures, and other resources are available and adequate to support nuclear safety. The

cause of the finding was determined to be associated with a cross-cutting aspect

of Resources in the Human Performance area because ExGen staff failed to identify and

address a nonconformance during verification of the quality of the HPCI system

PCV. Specifically, the inspectors determined there were multiple ways for ExGen to

reasonably identify a nonconformance associated with the PCV diaphragm which had not

been addressed. Furthermore, procurement implementing procedures did not provide

adequate guidance to ensure that procedure users would identify and resolve this issue.

Having comprehensive steps within the relevant procedure would likely have prevented

installation of the defective part at FitzPatrick.

ENCLOSURE 3

NOTICE OF VIOLATION

Exelon Generation Company, LLC

Docket No. 50-333

James A. FitzPatrick Nuclear Power Plant

License No. DPR-59

EA-20-138

During an NRC inspection conducted from April 10, 2020, through December 14, 2020, and for

which an inspection exit meeting was conducted on December 14, 2020, violations of NRC

requirements were identified. In accordance with the NRC Enforcement Policy, the violations

are listed below:

A. Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Appendix B, Criterion VII,

Control of Purchased Material, Equipment, and Services, requires, in part, that

measures shall be established to assure that purchased material, equipment, and

services, whether purchased directly or through contractors and subcontractors conform

to procurement documents. Documentary evidence that material and equipment conform

to the procurement requirements shall be available at the nuclear power plant or fuel

processing plant site and shall be sufficient to identify the specific requirements, such as

codes, standards, or specifications, met by the purchased material or equipment.

Contrary to the above, on December 16, 2017, the licensee did not ensure measures

were established to assure that purchased material, equipment and services conform to

procurement documents. Specifically, the licensee did not ensure that a replacement

high pressure coolant injection (HPCI) system oil pressure control valve (PCV)

conformed to procurement documents. As a result, on December 16, 2017, the licensee

accepted and installed for use a PCV at the James A. FitzPatrick Nuclear Power Plant

(FitzPatrick) that had a known nonconforming material defect (i.e., defective diaphragm)

that was first identified in a 10 CFR Part 21 report on July 3, 2010.

B. Title 10 CFR Part 50, Appendix B, Criterion XV, Nonconforming Materials, Parts, or

Components, requires that measures shall be established to control materials, parts, or

components which do not conform to requirements in order to prevent their inadvertent

use or installation. Nonconforming items shall be reviewed and accepted, rejected,

repaired, or reworked in accordance with documented procedures.

FitzPatrick Technical Specification (TS 3.5.1), in part, requires the HPCI system to be

operable in Modes 1, 2, and 3 with reactor steam dome pressure >150 psig. If the HPCI

system is determined to be inoperable, it shall be returned to an operable status within

14 days. If not restored to an operable status, the unit shall be shut down and in Mode 3

within 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.

Contrary to the above, from December 16, 2017, to April 10, 2020, the licensee did not

ensure that measures were established to control materials, parts, or components which

do not conform to requirements in order to prevent their inadvertent use or installation

and did not ensure that nonconforming items shall be reviewed and accepted, rejected,

repaired, or reworked in accordance with documented procedures. Specifically, staff

involved with the sale, inspection, and installation of the HPCI PCV to FitzPatrick failed

to ensure the PCV conformed to all procurement requirements and failed to reject the

nonconforming item. As a result, the valve was accepted and installed for use at

Enclosure 3

2

FitzPatrick. On April 10, 2020, the HPCI system was declared inoperable during a

monthly surveillance test as a result of a leak and system oil loss from the

nonconforming HPCI PCV that would have prevented the system from performing its

safety function. Consequently, the HPCI system was rendered inoperable prior to

April 10, 2020, for a period longer than its TS allowed outage time, and the unit was not

shut down and placed in Mode 3 within 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> in accordance with NRC reportability

guidelines.

These violations are categorized collectively as a problem and are associated with a White

Significance Determination Process finding.

Pursuant to the provisions of 10 CFR 2.201, Exelon Generation Company, LLC (the licensee) is

hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory

Commission, ATTN: Document Control Desk, Washington, DC 20555-0001 with a copy to the

Regional Administrator, Region I, and a copy to the NRC Resident Inspector at the facility that is

the subject of this Notice, within 30 days of the date of the letter transmitting this Notice of

Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation;

EA-20-138" and should include for each violation: (1) the reason for the violation, or, if

contested, the basis for disputing the violation or severity level, (2) the corrective steps that

have been taken and the results achieved, (3) the corrective steps that will be taken, and (4) the

date when full compliance will be achieved. Your response may reference or include previous

docketed correspondence, if the correspondence adequately addresses the required response.

If an adequate reply is not received within the time specified in this Notice, an order or a

Demand for Information may be issued as to why the license should not be modified,

suspended, or revoked, or why such other action as may be proper should not be taken. Where

good cause is shown, consideration will be given to extending the response time.

If you contest this enforcement action, you should also provide a copy of your response, with

the basis for your denial, to the Director, Office of Enforcement, United States Nuclear

Regulatory Commission, Washington, DC 20555-0001.

Because your response will be made available electronically for public inspection in the NRC

Public Document Room or from the NRCs document system (ADAMS), accessible from the

NRC Web site at http://www.nrc.gov/reading-rm/adams.html, to the extent possible, it should not

include any personal privacy, proprietary, or safeguards information so that it can be made

available to the public without redaction. If personal privacy or proprietary information is

necessary to provide an acceptable response, then please provide a bracketed copy of your

response that identifies the information that should be protected and a redacted copy of your

response that deletes such information. If you request withholding of such material, you must

specifically identify the portions of your response that you seek to have withheld and provide in

detail the bases for your claim of withholding (e.g., explain why the disclosure of information will

create an unwarranted invasion of personal privacy or provide the information required by

10 CFR 2.390(b) to support a request for withholding confidential commercial or financial

information). If safeguards information is necessary to provide an acceptable response, please

provide the level of protection described in 10 CFR 73.21.

In accordance with 10 CFR 19.11, the licensee may be required to post this Notice within two

working days of receipt.

Dated this 20th day of April 2021.