ML22334A138

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Transcript of Advisory Committee on Reactor Safeguards - Shine Operating License Application - October 21, 2022, Page 1-133 (Open)
ML22334A138
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NRC-2137
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Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

Advisory Committee on Reactor Safeguards SHINE Subcommittee Docket Number:

(n/a)

Location:

teleconference Date:

Friday, October 21, 2022 Work Order No.:

NRC-2137 Pages 1-73 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1716 14th Street, N.W.

Washington, D.C. 20009 (202) 234-4433

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 1

1 2

3 DISCLAIMER 4

5 6

UNITED STATES NUCLEAR REGULATORY COMMISSIONS 7

ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 8

9 10 The contents of this transcript of the 11 proceeding of the United States Nuclear Regulatory 12 Commission Advisory Committee on Reactor Safeguards, 13 as reported herein, is a record of the discussions 14 recorded at the meeting.

15 16 This transcript has not been reviewed, 17 corrected, and edited, and it may contain 18 inaccuracies.

19 20 21 22 23

1 UNITED STATES OF AMERICA 1

NUCLEAR REGULATORY COMMISSION 2

+ + + + +

3 ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 4

(ACRS) 5

+ + + + +

6 SHINE SUBCOMMITTEE 7

+ + + + +

8 FRIDAY 9

OCTOBER 21, 2022 10

+ + + + +

11 The Subcommittee met via Video 12 Teleconference, at 9:30 a.m. EDT, Ronald Ballinger, 13 Chairman, presiding.

14 15 COMMITTEE MEMBERS:

16 RONALD G. BALLINGER, Chair 17 VICKI BIER, Member 18 CHARLES H. BROWN, JR., Member 19 VESNA DIMITRIJEVIC, Member 20 GREGORY HALNON, Member 21 JOSE MARCH-LEUBA, Member 22 JOY L. REMPE, Member 23 MATTHEW SUNSERI, Member 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

2 ACRS CONSULTANT:

1 DENNIS BLEY 2

KEN CZERWINSKI 3

STEPHEN SCHULTZ 4

5 DESIGNATED FEDERAL OFFICIAL:

6 CHRISTOPHER BROWN 7

8 ALSO PRESENT:

9 MICHAEL BALAZIK, NRR 10 JOSH BORROMEO, NRR 11 NORBERT CARTE, NRR 12 CATHERINE KOLB, SHINE 13 SCOTT MOORE, ACRS 14 RYAN MYERS, SHINE 15 TRACY RADEL, SHINE 16 BILL WATSON, SHINE 17 DANIEL ARIZAGA, SHINE 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

3 TABLE OF CONTENTS 1

Page 2

Opening Remarks and Objectives 4

3 Staff Opening Remarks..............

7 4

Section 7.4.3, "Process Integrated Instrument Control 5

System" 6

By Shine Medical Technologies LLC.....

8 7

Section 7.4.3, "Process Integrated Instrument Control 8

System" 9

By NRC Staff

............... 24 10 Phased Startup Operations Supplement

...... 35 11 Phased Startup Operations, SER, Appendix A

... 51 12 Public Comment

................. 60 13 Committee Discussion

.............. 60 14 Adjournment................... 73 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

4 P R O C E E D I N G S 1

9:30 a.m.

2 CHAIRMAN BALLINGER: All right. It's 3

9:30. Let's begin the meeting. This is a meeting of 4

the SHINE Subcommittee of the Advisory Committee on 5

Reactor Safeguards. I'm Ron Ballinger, Chairman of 6

today's subcommittee meeting.

7 ACRS members in attendance are Charlie 8

Brown, Greg Halnon, Jose March-Leuba, Joy Rempe, Matt 9

Sunseri, and I see Vesna somewhere here, Vesna 10 Dimitrijevic. And if I've missed somebody, I'm sure 11 I'll get reminded.

12 MEMBER BIER: Yes, Ron.

13 CHAIRMAN BALLINGER: Yes, yes.

14 MEMBER BIER: This is Vicki Bier. I just 15 joined, and I don't know if you saw my email. I will 16 have to duck out for a while at around 11 Eastern.

17 CHAIRMAN BALLINGER: Yes, got it. Thanks 18 again. We also have our consultants, Dennis Bley and 19 Steve Schultz present. Chris Brown of the ACRS staff 20 is the Designated Federal Official for this meeting.

21 During today's meeting, the subcommittee 22 will have a discussion with the NRC staff and SHINE 23 Medical Isotope, Incorporated, concerning process 24 integrated instrument control system (PICS). They 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

5 start up in any other remaining questions concerning 1

life cycle. I might add that this is the last 2

subcommittee meeting for this effort, so it's been a 3

long road but we're almost at the end.

4 The rules for participating, part of the 5

presentations by the applicant may be closed. We 6

don't think that will be the case, but, if it is, 7

we'll have to make arrangements to close the meeting.

8 The rules for participating in all ACRS, 9

including today's, were announced in the Federal 10 Register on June the 13th, 2019. The ACRS section of 11 the U.S. NRC public website provides our charter, 12 bylaws, agendas, letter reports, and full transcripts 13 of all full and subcommittee meetings, including 14 slides presented there. The meeting notice and agenda 15 for this meeting were posted there. We have received 16 no written statements or requests to make an oral 17 statement from the public.

18 The subcommittee will gather information, 19 analyze relevant issues and facts, and formulate 20 proposed positions and actions, as appropriate, for 21 deliberation by the full committee. The rules for 22 participation in today's meeting have been announced 23 as part of the notice for this meeting previously 24 published in the Federal Register.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

6 Today's meeting is being held virtually 1

over Microsoft Teams. A telephone bridgeline allowing 2

participating for the public using their computer 3

using Teams or by phone was made available.

4 Additionally, we have made an MS Teams link process 5

and password available on the published agenda.

6 A transcript of today's meeting is being 7

kept. Therefore, we request that meeting participants 8

on Teams and on the Teams call-in line identify 9

themselves when they speak and to speak with 10 sufficient clarity and volume so they can be readily 11 heard. Likewise, we request that meeting participants 12 keep their computer and/or telephone lines on mute 13 when not speaking to minimize disruptions. The chat 14 features on Teams should not be used for any technical 15 exchanges. Let's see. I can control -- most 16 everybody looks like they're muted.

17 Again, I'd like to note that this is our 18 final SHINE Subcommittee interaction with the staff 19 and SHINE. We do have a November 15th subcommittee 20 meeting from 8:30 to 5, it's a whole day, in which the 21 subcommittee will work on remaining memos and work on 22 the draft final letter report. That subcommittee will 23 be open to the public.

24 We'll now proceed, and Josh, I see you 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

7 there. So please give any opening remarks that you 1

would like.

2 MR. BORROMEO: Thank you, Professor 3

Ballinger. My name is Josh Borromeo. I'm Chief of 4

the Non-Power Production and Utilization Facility 5

Licensing Branch. Today you're going to hear 6

presentations from the staff and SHINE on PICS, the 7

process integrated control system, which is a non-8 safety related system for the facility. And you'll 9

also hear an overview of the phased construction 10 approach and also our associated license and controls 11 the staff is putting in place to ensure a safe 12 operation while SHINE moves from phase to phase of 13 construction.

14 Now, I do want to recognize it's been a 15 long road, right, and in our internal chat we were 16 saying, okay, we've started these in February. So I 17 wanted to recognize that we still have some work to do 18 to get this thing over the finish line, but I do want 19 to express my appreciation for all the hard work that 20 the staff and SHINE has done to get us to this point.

21 And I also want to highlight my appreciation for ACRS 22 and ACRS staff for being flexible and identifying ways 23 to efficiently work to get us through this review.

24 So with that, I'll turn it over to SHINE 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

8 for their PICS presentation.

1 CHAIRMAN BALLINGER: Okay. Before we add 2

again, we now have Ken Czerwinski, another one of our 3

consultants in the chemistry area, that's joined the 4

meeting.

5 Okay. Let's go.

6 MR. MYERS: Hello. My name is Ryan Myers.

7 I'm an I&C engineer here at SHINE. Welcome to the 8

process integrated control system, PICS, presentation.

9 Next slide, please. Here's a look at the 10 topics that will be covered. First will be an 11 overview of the PICS main functions, then PICS network 12 security features. After that, we'll look at PICS 13 interfaces with safety-related systems. Next, our 14 PICS communications with vendor-provided non-safety 15 related control systems. And, finally, we'll look at 16 operator access to the PICS network using PICS 17 workstations.

18 Next slide, please. Here's Figure 7.1-1 19 from the FSAR showing the instrumentation and control 20 system architecture. The upper right corner of the 21 figure shows the PICS external interfaces with safety 22 and non-safety related systems. Unidirectional and 23 bidirectional communications with PICS are captured 24 here. The safety-related systems in the center of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

9 this figure were covered in previous NRC audit 1

discussions. PICS communications with the supervisor 2

and operator workstations and indication displays in 3

the facility control room are shown at the bottom of 4

the figure, along with PICS production facility HMI 5

communications.

6 Next slide, please.

7 MEMBER BROWN: Could you go back to the 8

other slide for a minute? This is Charlie Brown.

9 MR. MYERS: Sure.

10 MEMBER BROWN: I noticed, it's just a 11 question and maybe you've got an overarching answer 12 for this. This is the -- you primarily show Figure 13 7.1-1, which is the excellent representation of the 14 safety systems that we addressed in the last meeting.

15 The process control, process integrated control system 16 has a big box with nothing in it, which not unexpected 17 since that's separate. And there is a figure in the, 18 I think it's 7.3-1, but that one is nowhere near what 19 I call the detail that the 7.1-1 is for the safety 20 systems. It's, fundamentally, some block diagrams 21 with one line going everywhere, which leaves a little 22 bit -- you talked about ethernet inside of your PICS 23 operations, and it would be nice to hear a little bit 24 about how integrated these overall PICS things is when 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

10 we get to that point in the slides.

1 I'm just giving you a heads-up, there's a 2

question I had relative to the detail and how 3

integrated the -- because you do call it an integrated 4

system and how diverse -- not diverse; that's the 5

wrong word. I'm not looking for diversity. I'm 6

looking for separation of functions because there's 7

two or three dozen process systems that are part of 8

this overall process integrated control system. And 9

my question really boils down to is it a giant 10 computer that's running all those giant set of servers 11 where all the software is on one or two servers, or 12 are they independent systems which feed independently 13 into the control functions for the operators?

14 You don't have to answer that now. It's 15 just when we get to the appropriate point. Did I get 16 that across very well?

17 MR. MYERS: Yes.

18 MEMBER BROWN: Okay.

19 MR. BROWN: Excuse me. This is Chris 20 Brown. It looks like you were trying to go to full 21 screen. Can you -- this diagram is very small. Can 22 you try to change the view?

23 MR. MYERS: Yes, I'm just having a 24 challenge doing that. There we go. Sorry. It's my 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

11 first time driving.

1 MEMBER BROWN: We've got our magnifying 2

glass. A little humor to start the meeting.

3 MR. MYERS: So on to the next slide then.

4 PICS is a non-safety related control system used by 5

the plant operators to control and monitor facility 6

equipment throughout the radiation facility and 7

radioisotope production facility. PICS supports the 8

facility control room which contains the operator 9

workstations and the main control board.

10 The non-safety related instruments and 11 controls used throughout the plant are wired to the 12 local remote idle panels which then route back to the 13 PICS main distribution switch in the server room over 14 copper or fiberoptic cabling. The PICS HMI 15 workstations, including five system-specific remote 16 workstations, use thin clients connected to virtual 17 machines running on a server in the server room.

18 Next slide, please.

19 MEMBER BROWN: Did that just answer part 20 of my question?

21 MR. MYERS: I think so.

22 MEMBER BROWN: That these, all these 20 or 23 30, whatever it is, the large number -- and I'm not 24 arguing about the number. You obviously have a lot of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

12 things you have to control. So, fundamentally, 1

there's a giant server where all the software is 2

located for these systems. They're not separate PLCs 3

for every system. Is that a correct assumption, for 4

other than the ones shown up in the upper block of 5

Figure 7.3-1?

6 MR. MYERS: There are separate PLCs split 7

up by system. On the PICS side, there are five 8

separate, well, actually, seven PLCs and then three 9

for TPS. Those are split up, but they do communicate.

10 They're virtual machines, like HMI screens run 11 through, are on a stratus fault tolerant server that's 12 located in the server room.

13 MEMBER BROWN: Okay. So there is a -- so 14 this is stuff is, fundamentally, fed into -- if that 15 server fails, what happens? You lose all your 16 controls?

17 MR. ARIZAGA: Sorry. This is Dan Arizaga, 18 I&C engineer.

19 MEMBER BROWN: Yes.

20 MR. ARIZAGA: So, essentially, there is 21 redundancy in that with multiple thin clients, so, if 22 one of the servers goes down, you would have several 23 backup servers that would be able to pick up, so you 24 would have no interruption of the actual control PICS.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

13 MEMBER BROWN: Okay. So you've got 1

backups. So you've got parallel servers running, 2

which are all up to date for whatever is going on so 3

that the workstation operator can move from one to the 4

other server, as needed, to carry on operations; is 5

that correct?

6 MR. MYERS: Yes. It will switch to the 7

backup server automatically if the primary server were 8

to fail.

9 MEMBER BROWN: Okay, all right. Go ahead.

10 MR. MYERS: I can go into a little more 11 detail as we progress.

12 MEMBER BROWN: Okay. That's fine. Thank 13 you.

14 MR. MYERS: PICS network, architecture and 15 security, did I get through this one? Okay. The most 16 important PICS security feature is that there is no 17 connection to the internet, and the PICS devices are 18 not WiFi capable. PICS does have an outbound only 19 connection through a one-way data diode to the PICS 20 historian. The PICS manufacturing control network is 21 separated from the SHINE business network behind its 22 PLC, and its PLC communications are split into ten 23 virtual local area networks, or VLANs, one for each of 24 the ten PLCs.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

14 PICS has physical security implemented, 1

including the locking of control cabinets, the server 2

room, and physically blocking unused network ports.

3 The ethernet IP with CIP communication protocol used 4

for PICS is widely used to secure plants worldwide.

5 No remote access for monitoring or maintenance of the 6

plant is allowed either.

7 Next slide, please.

8 MEMBER BROWN: Stay there for a minute.

9 This is Charlie Brown again.

You say the 10 manufacturing network is segregated from the SHINE 11 business network. Does that mean it's not connected?

12 MR. MYERS: It's not connected at all.

13 MEMBER BROWN: Okay. That's all I was 14 looking for. Segregation could mean you have 15 segregated software within your servers that allows 16 you to operate, but you're totally disconnected.

17 That's all I wanted to know. Thank you.

18 MR. MYERS: PICS interfaces with safety-19 related systems. The safety-related systems, the 20 target solution vessel reactivity protection system, 21 TRPS, and the engineered safety features actuation 22 system, ESFAS, communicate with PICS through a one-way 23 isolated rs485 Modbus gateway. While the information 24 exchange is unidirectional from TRPS/ESFAS to PICS, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

15 PICS does send two cyclic redundancy checks, CRCs, per 1

Modbus message for error checking and verifying the 2

identity of the data.

3 Under normal operating conditions, PICS 4

allows operators to manually actuate TRPS/ESFAS 5

controlled components. The PICS controlled relays 6

have contacts in series with the TRPS/ESFAS controlled 7

relay contacts, so the safety and non-safety system 8

controls remain electrically isolated. TRPS/ESFAS can 9

remove component power, causing the components to fail 10 to their safe positions, regardless of PICS output 11 state.

12 After safety actuations, the enabled non-13 safety switch must be physically moved from the 14 disabled to the enabled position on the main control 15 board by the operator before a component reset request 16 can be sent from PICS. The actuation and priority 17 logic in TRPS/ESFAS must not be prevented by higher-18 priority inputs before TRPS/ESFAS will reset the 19 component, as requested by PICS.

20 The TRPS mode transition and component 21 reset request signals are sent from PICS to the safety 22 systems using a bit stream or binary pattern of 23 discrete relay outputs that are decoded by TRPS/ESFAS.

24 Unrecognized PICS output patterns will do nothing in 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

16 TRPS or ESFAS. PICS is designed so that it cannot 1

fail or operate in a mode that could prevent the TRPS 2

or ESFAS from performing its designated functions.

3 CHAIRMAN BALLINGER:

This is Ron 4

Ballinger. On bullet number one, two, three, four, 5

five, PICS provides signals to TRPS/ESFAS to 6

reposition components, da, da, da, da, da. Is this an 7

area where errors of commission or omission can impact 8

the safety side?

9 MR. MYERS: Can you --

10 MEMBER BROWN: Let me interpret his 11 question for you. If the operator doesn't do 12 something, does that affect the safety side --

13 CHAIRMAN BALLINGER:

Yes, either 14 intentionally or not intentionally.

15 MEMBER BROWN: Right.

16 MS. RADEL: This is Tracy. So the -- no, 17 no operator action is needed to respond to an accident 18 condition, so they don't need to do anything. We have 19 assessed thoroughly to ensure that, if they do, 20 anything that they do cannot impact the safety systems 21 from performing their safety functions.

22 MS. KOLB: And this is Catherine Kolb. So 23 the purpose of this is for the reset, which I believe 24 we discussed at a previous meeting. So after an 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

17 actuation from TRPS or ESFAS, you'd ensure that the 1

non-safety, enabled non-safety switch was in the 2

enabled position, and then you would be able to use 3

the PICS component, the PICS interface to reopen 4

components that had closed, for example to reset 5

things that had actuated.

6 There's no time requirements associated 7

with that in our design. There's no, you know, no 8

analogs, like power reactors sometimes have time 9

required actions in order for operators to do things.

10 This is just recovering from an accident at the 11 operator's discretion once the accident has been 12 mitigated or otherwise dispositioned to be safe.

13 CHAIRMAN BALLINGER: Thank you.

14 MR. MOORE: This is Scott Moore. I just 15 ask that each of the speakers identify themselves with 16 a full name before speaking, at least for the first 17 time. Thank you.

18 CHAIRMAN BALLINGER: Good point. Thank 19 you.

20 MR. MYERS: Next slide, please. PICS 21 vendor-provided non-safety related control system 22 interfaces. There are several vendor-provided control 23 system interfaces with PICS that provide the operators 24 in the facility control room with important process 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

18 monitoring information. Some of the vendor-supplied 1

control systems include the neutron driver assembly 2

system, NDAS; a super cell; and various auxiliary 3

control systems. Again, the most important thing is 4

that none of the PICS vendor-provided devices have 5

internet connections. Similarly, no remote access is 6

allowed. In unused communication, ports are blocked 7

or disabled. Many of the vendor-provided control 8

systems use ethernet, Modbus, or other industry 9

standard protocols to communicate with PICS. The 10 safety benefits of the object-oriented CIP protocol 11 over ethernet IP are employed by many of the vendor-12 supplied control systems.

13 Next slide, please. Vendor-provided non-14 safety related control system interfaces continued.

15 The Modbus connections tie into the PICS network via 16 Modbus interface modules or gateways, which provide 17 independently-configured communication ports specific 18 to their devices and systems. PICS Modbus networks 19 only communicate with read/write registers approved by 20 the vendors. Like the plant equipment using internet 21 IP with CIP, the building automation system, or BAS, 22 equipment uses BACnet/IP, another protocol commonly 23 used in plants for HVAC and system facility controls.

24 PICS monitors information from the non-25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

19 safety related vendor provided super cell and 1

radioactive liquid waste immobilization PLCs, along 2

with radiation monitors throughout the plant. PICS 3

communicates with the vendor-supplied NDAS control 4

system through providing permissive signals and 5

monitoring information.

6 Next slide, please.

7 MEMBER BROWN: Before you go on, this is 8

Charlie Brown again. The super cell, I'm trying to 9

think back to the facility figure. Are the super 10 cells within the irradiation units, or is that a big 11 separate -- I've forgotten.

12 MR. MYERS: That's on the RPF side.

13 MEMBER BROWN: Okay. So that's on the 14 production facility side. And there's how many super 15 cells, just one or I thought there were multiple super 16 cells.

17 MR. MYERS: Just the one.

18 MS. RADEL: This is Tracy Radel. Just to 19 clarify, there's one super cell that has ten 20 individual hot cells within it.

21 MEMBER BROWN: Okay. That's what, I was 22 trying to get to that. I was looking at your figures 23 from the text. I saw a number of workstations for 24 various super cells. Okay, I got it. Thank you.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

20 MR. MYERS: PICS workstations and network 1

access. Users who require access to the FactoryTalk 2

View Site Edition Supervisory Control and Data 3

Acquisition system will have independent accounts 4

created on the manufacturing domain. When logging in 5

to a PICS workstation, the operator's credentials are 6

authenticated against the valid accounts on the 7

manufacturing domain and workstation graphics are 8

view-only when no user is logged in.

9 Each PICS domain user will be assigned to 10 one of five domain groups, including maintenance, 11 operator, supervisor, administrator, or quality.

12 SCADA permissions are limited based on the assigned 13 domain group.

14 In addition to domain groups, users are 15 assigned to security areas which allow control of PICS 16 equipment. Control room operators and supervisors are 17 assigned to all security areas.

18 Next slide, please. And now for the final 19 slide, PICS workstations and network access continued.

20 A PICS workstation user can only take control of a 21 remote HMI after access is granted by the control room 22 supervisor. The control room supervisor can also take 23 back control of the PICS equipment at any time. Each 24 workstation and main control board thin client have 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

21 their own ten-minute backup power supplies provided by 1

a local UPS. The standby generator system should be 2

providing backup power before the local UPS runs out 3

of battery. If power to a remote operator workstation 4

were lost, that thin client's virtual machine session 5

would continue to run on the stratus fault tolerant 6

server in the server room.

7 That concludes the PICS presentation.

8 Thank you.

9 MEMBER BROWN: Can I ask -- this is 10 Charlie Brown again. Can I ask another question or 11 maybe two, if I can figure it out here.

12 MR. MYERS: Sure.

13 MEMBER BROWN: I just wanted to confirm 14 something. I think you said this earlier, but I 15 wanted to connect it with words in the FSAR. In 16 Section 7.3.5, 7.3.3.5, that's the access control and 17 cybersecurity section, second paragraph reads, the 18 PICS and other vendor-provided non-safety related 19 control systems do not allow remote access. You 20 talked about that a minute ago. Let me finish the 21 next point.

22 Paragraph six says vendor-provided non-23 safety related control systems communicate with the 24 PICS via ethernet or other industry standard digital 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

22 communication protocols. I'm assuming that the 1

ethernet is, there is no connection of any ethernet.

2 You're running an ethernet bus through the PICS. I 3

think you told us that in the previous meeting. Is 4

that correct? Is my memory correct?

5 MR. MYERS: Yes, it's a local internet 6

hardwired connection within the plant itself.

7 MEMBER BROWN: Okay. But it's strictly a 8

local interior internet communication systems, so you 9

can control multiple systems.

10 MR. MYERS: Right.

11 MEMBER BROWN: There is no connection to 12 that particular network or internet network to any 13 remote networks.

14 MR. MYERS: Correct.

15 MEMBER BROWN: Outside the facility, 16 outside the facility. I think you've said that. I 17 just wanted to -- the words were a little bit dicey in 18 terms of how it's phrased; that's all.

19 MR. MYERS: Yes, you're correct. There 20 are no ethernet connections outside of the facility.

21 MEMBER BROWN: Okay, all right. Thank 22 you. Let me see if -- go ahead.

23 MR. WATSON: Charlie, this is Bill Watson, 24 interim I&C manager. I did want to correct the record 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

23 on one point. There is an outbound data stream from 1

PICS to the PICS historian for sending information, 2

outbound only.

3 MEMBER BROWN: Yes.

4 MR. WATSON: That communication occurs 5

through a data diode or what the NRC calls a 6

deterministic device, so it, in no physical way, can 7

even allow any kind of external communications to come 8

in to PICS. It's basically a one-way, you know, 9

hardware device. It only allows PICS to report, you 10 know, performance data out to the historian. So I 11 didn't want --

12 MEMBER BROWN: Go ahead, go ahead.

13 MR. WATSON: I just wanted to make sure we 14 were clear on that point, that there actually is a 15 connection but it is outbound only and it's a hardware 16 outbound only. It can't be defeated in any way.

17 MEMBER BROWN: Yes, mentioned that a few 18 minutes ago. I guess my question on that is -- how 19 can I phrase this properly? You've probably read 20 this, I've reiterated this many times. A hardware-21 based device can have bidirectional hardware-based 22 devices, but it's configured by software. A true data 23 diode is not configured by software. In other words, 24 it's hardwired and it can only have one unit 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

24 directional. Nothing from external can backfill 1

through it or be captured somewhere else and then 2

reverse that or turn it into a bidirectional.

3 So I presume the data diode interpretation 4

in this is strictly one way of passing data in and 5

only one thing to couple it and send it out, and 6

there's no software package that configures that.

7 It's hard configured.

8 MR. WATSON: That's absolutely correct in 9

the case of the data diode that's used for PICS.

10 MEMBER BROWN: Okay. That's all I wanted 11 to know. Thank you very much. And thank you all for 12 doing that so I didn't have to say anything.

13 CHAIRMAN BALLINGER: So that was your last 14 slide?

15 MR. MYERS: That's correct.

16 CHAIRMAN BALLINGER: Okay. If there 17 aren't any questions from the members or consultants 18 on this presentation, we can switch over. Here we 19 are. We're already there. I don't know who is the 20 presenter in this case.

21 MR. CARTE: Norbert Carte from I&C, NRR.

22 CHAIRMAN BALLINGER: I'm a slow reader.

23 Thanks.

24 MR. CARTE: Once again, this is Norbert 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

25 Carte from the Instrumentation & Control Branch.

1 We're assisting DANU in the review of the application.

2 Next slide, please. So, predominantly, 3

the review involves the same reviewers as you've seen 4

previously. However, the bulk of the review for PICS 5

was done by me, although there was some minor 6

involvement by others.

7 Next slide, please. We use the same set 8

of guidance, obviously different sections, for our 9

review of PICS. Next slide, please. I used red a 10 little bit to highlight what's new and different from 11 what you've seen before.

12 Next slide, please. So what we're looking 13 now is at PICS. What you've seen before was basically 14 HIPS, TRPS/ESFAS radiation monitoring systems.

15 Next

slide, please.

So the PICS 16 description is actually a little bit segmented in the 17 sense that there is some description in 7.3 and 18 obviously 7.2, and as well as 7.6, which is the 19 control console display instruments. Most of the 20 control console and display stuff is addressed by HFE, 21 but it is technically part of PICS, so it was covered 22 in the SER section on PICS.

23 And, again, the SHINE facility has two 24 distinct parts in a radiation facility and a refuel 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

26 radioisotope processing facility and one control room 1

and one PICS for everything. Well, yes, the TRPS is 2

for each irradiation unit.

3 So the safety of the facility is, in part, 4

defined by two things: the criteria on the PICS 5

systems and the criteria on the protection systems.

6 But the requirements that the protection system be 7

independent from the PICS system is not a requirement 8

placed on the PICS, it's a requirement placed on the 9

protection systems, and that was covered separately.

10 Now, there isn't necessarily a requirement that they 11 be diverse or different, but they are just by the 12 nature of the technologies used.

13 Next slide, please. So the following 14 three slides are three depictions from the FSAR of 15 what constitutes the PICS. I won't spend a lot of 16 time on this, but this is a little bit more detailed 17 and is a little bit what Charlie was asking about on 18 the other slides.

19 So next slide, please. This is the 20 gateway communication between the safety system and 21 the non-safety and basically what it's showing is that 22 there are two predominant communication paths; and, 23 within those communication paths, there are multiple 24 instances of one-way communication. So it's not 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

27 possible to communicate effectively into the TRPS or 1

ESFAS, and that is one of the things that ensures 2

independence.

3 The other thing that ensures independence 4

is that, in general, the safety systems are failsafe 5

on loss of power and the safety actuation is to lose 6

power. Those two relays are in series, as described 7

in the previous presentation, so that's a little bit 8

how, another way that the systems are independent.

9 This is the digital communication independence that 10 the series power relays are the actuation 11 independence.

12 Next slide, please. So, in essence, the 13 control board has some static displays, as well as 14 some manual switches. What you see is a little bit 15 the ESF, which has, it's the middle display. It has 16 that little operate safe shutdown position for the 17 enable facility operation key switch.

18 Next slide, please. So, again, we need to 19 summarize a little bit the NRC's approach to safety 20 regulation. So it's a layered approach, and, in that 21 layer, we do certain types of review. So the 22 application identifies the principal safety concerns, 23 the design criteria effectively establish the 24 performance objectives that, if met, will ensure that 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

28 the reasonable assurance of adequate safety against 1

the safety considerations. The design bases are, in 2

effect, the functions and values performed by the 3

system and used in the analysis to demonstrate that 4

normal operation, as well as anticipated events, will 5

not cause the performance criteria to be exceeded.

6 Then, finally, the last layer of the 7

review, and this is predominantly where I&C falls in, 8

is that the equipment performs the design basis 9

functions and values and misbehaviors of the equipment 10 do not exceed the assumptions in the safety analysis.

11 So predominantly -- next slide, please -- our review 12 is to ensure that the misbehaviors of the equipment do 13 not violate the safety analysis. So that, in essence, 14 required us to look at a subset of the design criteria 15 in the FSAR, and what you see in the safety evaluation 16 and summarized below is the subset of criteria that we 17 looked at to ensure safety.

18 Next slide, please. So the safety 19 analysis, and so, as we were summarizing before, in 20 effect, a system, our view of the world is that there 21 are two types of systems in a facility, ones that 22 generate events and ones that either prevent or 23 mitigate or alarm and notify about those events. So 24 the analysis demonstrates that the protection system 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

29 ensures that all events generated do not endanger the 1

health and safety of the public, and the PICS review, 2

the FSAR, includes an analysis of the HIPS equipment 3

or a summary of the analysis of the HIPS equipment, 4

which we did look at during the audit, and that 5

summary concluded that the failure modes of the HIPS 6

equipment were bounded by the safety analysis 7

documented in the FSAR or summarized in the FSAR.

8 There were two sort of exceptions to that 9

which impose additional requirements on the 10 architectural design so that those failures would not 11 exceed what was already analyzed. But that level of 12 detail is not really necessary in the FSAR and, 13 therefore, is not in the FSAR. It was looked at 14 during the audit.

15 So, again, the PICS is independent from 16 the TRPS and ESFAS by multiple ways, the digital 17 communication we saw earlier, the series, relays for 18 power to the controlled components. And the analysis 19 of the failure, the effects of failures is described 20 in the FSAR as summarized on this slide.

21 MEMBER BROWN: Norbert?

22 MR. CARTE: Yes.

23 MEMBER BROWN: You can correct me if I'm 24 wrong, but I hope I'm not. When we say the PICS is 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

30 independent from the TRPS and ESFAS, there are 1

communications from the facility control room that go 2

through the PICS, but it comes up through the hardware 3

module or something like that, I've forgotten what 4

it's called, for specific, but it's unidirectional 5

type information. It's not stuff, it's control 6

functions is what I'm saying. It's nothing that could 7

interfere with the operation of the TRPS or ESFAS.

8 MR. CARTE: Right. Actually, maybe the 9

wording on that slide is slightly --

10 MEMBER BROWN: Yes, I'm looking at Figure 11 7.1-1, and you can very clearly see that there are 12 interactions from the workstations to the PICS and 13 then go out up to that, whatever it's called, I can't 14 read it. I don't have my magnifying glass right now.

15 MR. CARTE: Yes, technically, you're 16 correct. The wording on this slide, it's not a 17 bidirectional wording, and it's actually, I would say, 18 incorrect. The TRPS and ESFAS are independent from 19 PICS. The PICS is not necessarily independent from 20 the TRPS. But our view is that any failure of the 21 PICS would not inhibit the TRPS and ESFAS from 22 performing its function and, in that sense, they're 23 independent.

24 MEMBER BROWN: Yes, I got that.

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31 MR. CARTE: There is some information --

1 MEMBER BROWN: I just wanted to point out 2

the discrepancy; that's all.

3 MR. CARTE: Yes. So there is information 4

that goes from the TRPS and ESFAS to the PICS and 5

failures of that information would result in loss of 6

that information to PICS. But the TRPS and ESFAS is 7

failsafe, so if that information were missing, like 8

sensor failures, then the TRPS would failsafe to the 9

safe state. But, in essence, you're correct. That 10 statement is wrong. TRPS and ESFAS are independent 11 from PICS.

12 CHAIRMAN BALLINGER: Yes, this is Ron 13 again. It seems like we're, Charlie and I, are kind 14 of beating a dead horse on this, but this is the crux 15 of the analysis after all.

16 MR. CARTE: Yes. And so we talked about, 17 and I guess there was mention of the third. What I 18 initially talked about was the digital communications, 19 which is one way out from TRPS to PICS. I also 20 mentioned the relays interrupting power to the 21 controlled or protection devices, controlled and 22 protection devices, we would say the actuated devices.

23 What was mentioned in the PICS discussion 24 that was a third point was that there is a priority 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

32 module in effect that prioritizes the non-safety 1

inputs, and those non-safety inputs, if you examine 2

the logic in TRPS, can only work when there is no 3

manual or automatic safety actuation commanded by the 4

protection system. And in those instances, you can 5

then reset the protective action of the protection 6

system. In other words, basically, the condition 7

requiring the protective action needs to clear, for 8

the most part, before you can reset.

9 MEMBER BROWN: I got that out of the 10 reading of the FSAR and your SER.

11 MR. CARTE: Okay. Thank you. Next slide.

12 So, in essence, the design bases is essentially 13 included in Section 7.3.1, which describes the 14 variables monitored and

alarmed, the control 15 functions, the interlocks and permissives that are 16 performed by the PICS system.

17 Next slide, please. And based on the 18 review of the independence aspects of the TRPS from 19 PICS, as well as the detailed analysis by SHINE 20 summarizing the FSAR, PICS equipment failures are all 21 bounded by the analysis summarized in the safety 22 analysis sections of the FSAR. We reached a 23 conclusion that PICS performs its role in providing 24 reasonable assurance of adequate safety.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

33 Next slide, please. Are there any 1

questions?

2 MEMBER BROWN: I'm trying to figure it 3

out. I lost track of one of my questions here. This 4

is Charlie again. Hold on for a second. Oh, okay.

5 There was one area, and I understand what the FSAR 6

said, it was in Section 7.3.1.3.11, and this is the 7

target solution vessel protection in ESFAS and its 8

relationship. There were words like safety-related 9

components that are capable of being actuated by the 10 TRPS or ESFAS but also have a non-safety related 11 function related to production achieve their safe 12 state by having power removed. And then the converse 13 of that is safety-related components that are capable 14 of being actuated but do not have a non-safety related 15 production are not controlled directly by PICS, but 16 there is -- the way I read this is, the TRPS does have 17 a non-safety related function and it feeds those 18 functions.

19 Can you explain -- it achieves a safe 20 state as a result of what? A malfunction so that it 21 can't affect the facility functions? You know what 22 I'm talking about?

23 MR. CARTE: A little bit. Let me, I think 24 the way to think about the scheme is a rod control 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

34 system. So, basically, in a power reactor, PWR, rod 1

control system, you have non-safety control of the 2

rods, but the safety system removes power and the rods 3

drop, and it goes to a safe state. And it's that same 4

configuration on the TRPS and ESFAS. All of the safe 5

states are achieved by loss of power, so, if you get 6

failures in the TRPS, you remove power, and that 7

includes sensor failures or self-diagnostic failures 8

of equipment, and that's how safety is assured.

9 So, in essence, the non-safety side 10 control is sort of irrelevant. All you're worried 11 about is that the failures are either detected and 12 protected against and/or do not exceed the assumptions 13 in the safety analysis.

14 MEMBER BROWN: Let me -- okay, I got that.

15 I'm looking at how it achieves it functionally. There 16 was another sentence where it said, in other words, it 17 has some connection to some production function, but 18 then it says -- so it's sending information to a 19 production function of some kind. Then it says should 20 a safety actuation be required, the TRPS or ESFAS 21 opens a contact in series with the power supply to 22 whatever component it was interacting with, causing it 23 to achieve its safe state also, regardless of the 24 control signals from the PICS. I read that positively 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

35 and that, if you have some production function going 1

on, you get a trip, the TRPS will terminate that 2

function by turning off its power supply via a relay 3

contact.

4 MR. CARTE: Correct.

5 MEMBER BROWN: That's the way I read that 6

sentence, and I don't have a problem with that, at 7

least as long as that reflects satisfaction with 8

whatever production is going on. I mean, SHINE 9

proposed it, so I presume they've looked at that.

10 MR. CARTE: Right. That is correct.

11 MEMBER BROWN: Okay. So I understand 12 what's going on correctly then.

13 MR. CARTE: Right. It's basically, 14 everything follows the pattern of a rod control 15 system.

16 MEMBER BROWN: Okay. I got it. I 17 understand the analogy. Thank you. That's all I had.

18 Ron, I'm done.

19 CHAIRMAN BALLINGER: Okay. Thank you.

20 Are there any other questions from members or 21 consultants on this presentation? Hearing none, now 22 we need to shift topics and go into the phased startup 23 presentation. So I guess SHINE needs to bring up 24 their slides. Who's the presenter?

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

36 MS. RADEL: Hi, this is Tracy Radel. I'll 1

be presenting on the phased startup.

2 CHAIRMAN BALLINGER: Thanks.

3 MS. RADEL: So here's the outline of what 4

we'll go through today. I'm going to start out with 5

the philosophy around phased startup operations, move 6

into descriptions of each of the phases, and then more 7

specifically into the IF systems, RPF systems, I&C 8

systems, electrical aux, and then finally conclude 9

with the safety analysis aspects.

10 Next slide. So the overall philosophy is 11 to meet the national need for Moly-99 production as 12 soon as possible while also ensuring all requirements 13 related to public health and safety are met. We've 14 proposed phased startup operations to provide 15 flexibility for challenges that we expected to arise 16 during procurement, installation, and testing.

17 The key considerations we had for the way 18 the phases are structured were to ensure that all the 19 design criteria and safety functions were met during 20 all phases. Our goal was to simplify the process 21 boundary isolations, as well as the confinement 22 boundary isolations, and to minimize the impact on 23 operating portions of the facility.

24 I do want to note that our procurement and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

37 installation philosophy was not inherently impacted by 1

phased startup operations approach. SHINE is 2

procuring the equipment for all irradiation units at 3

the same time. No phasing on that. Fabrication for 4

most of the equipment is naturally being done and set 5

for batches because there are eight units' worth of 6

equipment, resulting in a staggered delivery. And as 7

challenges have been encountered in the fabrication 8

process, we have prioritized the phase one equipment.

9 Equipment will be installed as soon as 10 possible after it's received on site. So while the 11 primary focus is on getting phase one equipment 12 installed, we will not hold off installation of 13 equipment for later phases if it is ready to go in and 14 the construction team has bandwidth for installation.

15 Next slide. The phases are described 16 here. So for phase one, the facility structure and 17 nitrogen system structure fully installed, IUs one and 18 two are fully installed, and when I refer to an 19 irradiation unit, or IU, it includes the IU-specific 20 instances of the subcritical assembly systems, the 21 neutron flux detection systems, target solution 22 vessel, off-gas systems, primary cooling systems like 23 water pool system, and radiological ventilation Zone 24 1 equipment located in the cooling room. This 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

38 includes both RVZ1r and RVZ1e equipment.

1 For phase one, the tritium purification 2

system train A will be installed, and then the 3

auxiliary and support systems, with the exception of 4

the IU-specific instances of PCLS, LWPS, and RVZ1 5

equipment that were mentioned above. And then the 6

radioisotope production facility systems, with the 7

exception of the iodine and xenon purification and 8

packaging and the radioactive liquid waste 9

mobilization selective removal capabilities.

10 So Figure 1.1-1 of the phased startup 11 supplement provides a visual representation of the 12 phasing showing the physical areas for installation in 13 each phase can be helpful for understanding what's 14 installed for each phase of operation.

15 Next slide.

Phase two brings in 16 irradiation units three, four, and five and TPS train 17 B. Phase three brings in irradiation units six, 18 seven, and eight and train C of the TPS equipment, 19 along with the RLWI selective removal capability and 20 the material staging building. Phase four is bringing 21 in the iodine and xenon purification and packaging 22 capability.

23 Next slide. On the irradiation units 24 specifically, they are designed and operated at a unit 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

39 level. Each IU has unit-specific instances of ESFAS, 1

NDAS, light water pool, irradiation biological shield; 2

and each IU is supported by a unit-specific instance 3

of PCLS.

4 The support system and process interfaces 5

with the IUs are isolated to support the phased 6

startup operation. Specifically, the auxiliary 7

systems, RPCS, facility nitrogen handling system, 8

facility chemical reagent system, nitrogen system, and 9

radiological ventilation zone include isolations to 10 support the phasing.

11 Next slide. In the tritium purification 12 system trains, the TPS as a whole consists of three 13 independent trains, and each TPS train supports 14 specific NDAS units. These train divisions are 15 supporting the phased operation, so each of these 16 trains includes independent thermal cycling absorption 17 process, or TCAP; the TPS NDAS interface lines; 18 secondary enclosure cleanup systems; vacuum impurity 19 treatment systems; connections to the NDAS secondary 20 enclosure cleanup; and TPS gloveboxes.

21 The tritium confinement boundary for each 22 TPS train is independent and isolated from the other 23 TPS trains, and no portion of the tritium confinement 24 boundary is shared between TPS trains. Isolations are 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

40 provided at the TPS interface points to facility 1

systems to allow the trains to be connected and 2

commissioned without impacting other TPS train 3

operation.

4 Next slide. On the RPF side of the 5

facility, the RPF systems are installed to support 6

phase one operation, with the exception of the IXP 7

system and selective removal within the RLWI. Note 8

the capability to solidify liquid waste is installed 9

as part of phase one. During phase one through three 10 operations, the IXP system is not installed and the 11 IXP hot cell is exploited from the super cell 12 containment boundary. Connections to the IXP system 13 are isolated during phase one through three.

14 The capability of the RLWI system to 15 remove the classification driving isotopes is not 16 available during phase one and phase two operation.

17 During phase one and phase two, liquid waste is stored 18 in the subgrade. We do not anticipate having to 19 solidify liquid waste prior to phase three operation 20 due to the capacity of the storage within the RLWS.

21 Waste solidifying during phase one and phase two may 22 be higher dose and higher waste classification than 23 waste solidified during phase three or four.

24 Solidified liquid waste would be stored in the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

41 portholes prior to shipment to disposal site.

1 Next slide. During phased startup 2

operations, the instrument and control systems are 3

installed to the extent practicable, given the extent 4

of equipment installation. IU-specific instances of 5

the TPS reactivity protection system are brought 6

online with the associated IUs and the applicable 7

phases.

8 There are nine TRPS cabinets installed in 9

the facility control room. All cabinets will be 10 installed prior to phase one operations. Those 11 cabinets are divided in the following way: So the 12 first three cabinets are the division A, B, and C for 13 IUs 1 and 2. The second set of three cabinets are 14 division A, B, and C for IUs 3, 4, and 5. And the 15 final set of three are the Division A, B, and C 16 cabinets for IUs 6, 7, and 8. So the division amongst 17 the TRPS cabinets does support phased startup 18 operations.

19 The engineering safety feature actuation 20 system is installed to support phase one operations.

21 We did implement a new capability to disable the 22 inputs that are not used during later phases. These 23 disabled inputs are restored and verified to be 24 operable prior to entering the technical 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

42 specifications mode of applicability associated with 1

the given input. Disabled inputs are listed in Table 2

7.5-1 of the supplement, and the safety functions not 3

utilized during particular phases are listed in Table 4

7.5-2 of the supplement.

5 MEMBER BROWN: This is Charlie Brown. Can 6

I ask you a question relative to the last bullet?

7 MS. RADEL: Yes.

8 MEMBER BROWN: I understand what you've 9

just gone through, but the ESFAS is an overall 10 facility piece of equipment, not like the TRPS which 11 is identified with each IU. And I'm only bringing 12 this up because of past experience of doing things 13 piecemeal in my Navy programs when we were building 14 submarines or aircraft carriers.

15 Your ESFAS is going to have all functions.

16 You talked about disabling outputs. It's not just 17 outputs, it's also inputs that you have to be careful 18 of, depending on how they're used in the software.

19 I've been there and done that and you've got to be --

20 all I'm doing is providing a little unneeded advice 21 probably. It's just very difficult to ensure you 22 don't have some stray piece of information come in and 23 all of a sudden gum up the works.

24 I'm not disagreeing with the approach 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

43 you're taking. I totally agree with the phased 1

approach. It's just a matter of, for an overall total 2

facility system, which has all that information 3

already built into the software, you're not going to 4

be piecemealing that software. It should be complete 5

when you start at the very beginning, and I've taken 6

that's correct based on what you've just said. I'm 7

just --

8 MS. RADEL: Just to clarify, the disable 9

function is for the inputs into the system and is done 10 through the maintenance workstation and verification 11 of those inputs being disabled for a particular phase 12 or enabled to support a particular phase.

13 MEMBER BROWN: I got that, but you've also 14 got outputs.

15 MS. RADEL: Yes, so that is the --

16 MEMBER BROWN: You can't ignore that.

17 MS. RADEL: So that's the safety function, 18 you know, the safety functions that wouldn't be 19 actuating during particular phases. Those are very 20 limited within the ESFAS.

21 MEMBER BROWN: Okay. I'm just, before you 22 start lighting off the first three, you've just got to 23 make sure those outputs are truly not going to affect 24 anything, that's all, so that you don't mess up the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

44 systems that you are actuating. I'm just a 1

grandfather offering advice.

2 MS. RADEL: I appreciate the advice.

3 Thank you.

4 MEMBER BROWN: Okay. Thank you.

5 MS. RADEL: Okay. The IU-specific 6

instances of the neutron flux detection system are 7

brought online with the associated IU. The safety-8 related process radiation monitors are installed, to 9

the extent practical, given the extent of equipment 10 installation. There are safety-related process 11 radiation monitors associated with the individual IUs, 12 as well as the TPS trains, and those are installed as 13 that equipment is brought online.

14 Safety-related process radiation monitors 15 associated with the IXP cell are installed prior to 16 phase four operations. Table 7.7-1 provides a 17 detailed listing of the radiation monitor phasing.

18 Process integrated control system hardware 19 is installed prior to phase one operations, with the 20 exception of hardware associated with TPS trains B and 21 C. PICS monitoring and controls associated with 22 equipment that's not yet installed or not yet operable 23 to support phase one are tested and placed into 24 operation as required for the given phase.

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45 Next slide.

1 MR. SCHULTZ: Tracy?

2 MS. RADEL: Yes.

3 MR. SCHULTZ: This is Steve Schultz.

4 There are non-safety related radiation monitors 5

associated with the PICS system. The PICS system 6

reads them. Are they going to be installed? What is 7

the schedule for --

8 MS. RADEL: All of the non-safety related 9

radiation monitors, yes, are installed as part of 10 phase one.

11 MR. SCHULTZ: I'm sorry. I didn't catch 12 the last part of the response.

13 MS. RADEL: Sorry. Yes, the non-safety 14 related radiation monitors are all installed as part 15 of phase one.

16 MR. SCHULTZ: Great. Thank you.

17 MS. RADEL: Next slide. The normal 18 electrical power supply system, or NPSS, and the 19 uninterruptible electrical power supply system, UPSS, 20 are installed in full to support phase one operations.

21 Loads on the NPSS and UPSS that are not yet installed 22 or not yet operable have the associated isolation 23 device removed or placed into an out-of-service 24 condition. Cabling associated with equipment not yet 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

46 installed is installed to the extent practical with 1

the power removed at the associated panel or load.

2 The non-safety related standby generator 3

system is also installed to support phase one 4

operations.

5 MR. BLEY: Tracy, Dennis Bley. Do you 6

anticipate -- well, I guess you've already told us 7

this. Never mind. I was wondering about the amount 8

of unconnected cable that's going to be there, but it 9

really doesn't matter. It will be from the source to 10 where the equipment will eventually be installed for 11 the most part?

12 MS. RADEL: The cabling and panels will be 13 installed out to the remote panels as part of phase 14 one and then --

15 MR. BLEY: And that includes the remote 16 panels?

17 MS. RADEL: Yes, it includes the remote 18 panels. And then the cabling beyond that will be 19 installed depending on equipment installed.

20 MEMBER BROWN: Okay. Along with the final 21 connection back to the power supply?

22 MS. RADEL: Yes. Auxiliary systems. The 23 RVZ1 recirculating subsystems. Our RVZ1r units 24 support individual IU cells and are installed with the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

47 corresponding IU. A portion of the RVZ1e subsystem is 1

also installed with the corresponding IU that is the 2

portion of the system that is located within the 3

cooling rooms.

4 Supply lines from auxiliary systems that 5

are supplying each of the irradiation units have 6

manual isolation valves and blank flanges or caps to 7

support phased startup operations. And because of 8

normal variation and flexibility in facility 9

operations, the auxiliary systems are designed to 10 handle the variable loads without any modifications.

11 Next slide. For the accident analysis, a 12 hazard evaluation was performed to identify new or 13 different accident scenarios, including changes to 14 likelihood or consequence of existing accident 15 scenarios. The likelihood and consequence for these 16 new or different accident scenarios were then 17 evaluated and compared to the risk matrix and safety-18 related controls were applied to prevent or mitigate 19 the accident scenarios in the method that was 20 consistent with what's described in Chapter 13(a)(2) 21 of the FSAR.

22 No new accident categories were identified 23 as part of phased startup operations. And no 24 increases to the consequences of existing accident 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

48 scenarios covered in Chapter 13 of the FSAR were 1

identified.

2 There were five new accident sequences 3

within the existing accident categories that were 4

identified and five existing accident scenarios were 5

re-evaluated for increased likelihoods. Four new 6

credited entry controls and three new credited 7

administrative controls were added during phased 8

startup operations to prevent the new or different 9

accident scenarios.

10 And this is the final slide of my 11 presentation. Any questions?

12 MEMBER SUNSERI: Tracy, this is Matt 13 Sunseri. I've got a question for you. All these 14 physical analysis controls seem pretty thought out to 15 me. Can you speak a little bit towards the controls 16 that you will have in place for personnel access, 17 construction personnel access, operations personnel 18 access, such that, for a lack of better word, I'll use 19 the term unauthorized individuals aren't exposed to 20 radioactive material or radiation and that the 21 construction workers don't impede operators from 22 getting where they need to be to operate the plant?

23 And one last component of that is what 24 oversight of the construction activities will be in 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

49 place such that they won't drift from their 1

construction activities and work on operational 2

equipment? That's a long one, but it's kind of the 3

administrative controls that you're going to have.

4 MS. KOLB: Yes, this is Catherine Kolb.

5 I'll respond to that question. So SHINE will 6

implement our physical security plan, our radiation 7

protection program, which includes access control to 8

the facility. So if workers, construction workers, 9

need to have regular access to the facility, they'll 10 be badged and trained as rad workers if they need to 11 to be able to access their normal work locations or 12 else, per the provisions of the plan, they will be 13 escorted by people who are trained and authorized, and 14 we intend to fully implement those two plans.

15 The other question about oversight of 16 construction activities, once the facility has its 17 operating license for phase one, we would expect and 18 have processes in place for people doing work for the 19 facility to check in with the control room as if we 20 were doing normal maintenance for the facility so that 21 the operators are cognizant of large activities that 22 are going on in the facility.

23 I know we don't have the general 24 arrangement drawing in the presentation, but it is in 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

50 the phase supplements. And you will notice that most 1

of the activity is localized to the specific radiation 2

unit cells that would be worked on during the phased 3

approach, so we would not expect, you know, large 4

construction activities to be taking place, you know, 5

like throughout the facilities. So it should be, we 6

are expected to be able to coordinate that during the 7

phased approach installation activities.

8 MEMBER SUNSERI: Okay. That sounds 9

reasonable to me. I was just thinking about when we 10 talked through the plant a few weeks ago there was a 11 couple of places, and I just remember one and I 12 probably will get the equipment mixed, but I think the 13 irradiation units were on one side and the tritium 14 purification was on the other side of the hall in this 15 real long hall, so I can imagine that might get pretty 16 busy in there when you're operating half of it and 17 working on the other half. Thanks.

18 MS. KOLB: Yes. I understand your point 19 there, and your recollection is correct on the 20 arrangement of the facility. You know, we intend to 21 install everything that we can to the extent practical 22 to minimize that, but, yes, we're just intending to 23 implement the processes and procedures as we have 24 described them.

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51 MEMBER SUNSERI: Thank you.

1 MS. RADEL: Any other questions? Okay.

2 Thank you.

3 CHAIRMAN BALLINGER: Hearing none, thank 4

you very much. I think we would sort of be scheduled 5

for a break around now, say at 11, if we were to go 6

that far, but we only have one more presentation to go 7

and then discussion. So why don't we go with this 8

presentation, and then, if we think discussions are 9

going to take a longer time, we'll have a break before 10 that.

11 So unless I hear an objection from 12 members, let's go with the NRC presentation. Thank 13 you.

14 MR. BALAZIK: Can everybody hear me okay?

15 CHAIRMAN BALLINGER: I can hear you fine.

16 MR. BALAZIK: Perfect. Thank you. Good 17 morning. My name is Michael Balazik. I'm the NRC 18 project manager for SHINE in the Office of Nuclear 19 Reactor Regulation within the Division of Advanced 20 Reactors and Non-Power Production and Utilization 21 Facilities. And this morning, I'll be presenting the 22 staff's review of the phased approach to startup.

23 Next slide, please. Okay. So the 24 regulatory requirements that the staff applied to this 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

52 portion of the review were 50.34, contents of 1

applications and technical information; 50.40, common 2

standards; and probably the most important one, 50.57, 3

the issuance of operating license.

4 Next slide, please. Guidance hasn't 5

changed. We pretty much use the standard guidance 6

we've been using for this entire review. NUREG-1537 7

and the final Interim Staff Guidance for licensing of 8

radioisotope production facilities.

9 Next slide, please. All right. So, 10 quickly, I'll just go over a summary of the 11 application. Tracy provided a lot more detail than I 12 would. Back in January of this year, SHINE did 13 supplement the SR-described four-phase approach to 14 startup operations. This phased approach is staggered 15 over a couple of years and planned to be completed in 16 the 2025 time frame.

17 So within the supplement, SHINE describes 18 the impacts, the technical impacts, along with 19 information differences for each chapter of what I'll 20 call the full design facility FSAR. Within the 21 supplement, SHINE identifies equipment isolation 22 points and the isolation methods for each phase for 23 the different equipment.

24 So some of the chapters that were most 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

53 impacted by this phased approach to startup were 1

Chapter 4, Chapter 7, Chapter 9, and 13.

2 Next slide, please. All right. Just 3

continuing on with a summary of the application. Back 4

in February of this year when we provided an overview 5

to ACRS full committee on the SHINE review, we did 6

talk about this phased approach to startup. And I 7

remember one member saying that, you know, this is 8

kind of analogous to plug and play. I can't remember 9

if he said that, but that's, you know, pretty much our 10 look on a majority of these items.

11 So the irradiation units, they're designed 12 and operated as independent units. The TPS, which 13 consists of three independent trains to support the IU 14 operation, so TPS train Alpha will support phase one, 15 and trains Bravo and Charlie, they'll support the 16 operation of the subsequent phases.

17 With the exception of the iodine and xenon 18 purification and packaging system and the radioactive 19 liquid waste isolation, all systems for the production 20 facility will be installed to support phase one 21 operations. And for instrument and control for TRPS, 22 it's IU-specific, and some of the inputs for the 23 ESFAS, which Member Brown was talking about, is an 24 entire facility system and, along with PICS, some of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

54 those inputs are disabled and brought on as the phases 1

come in.

2 And discussing Chapter 13, there were five 3

new accident sequences that were identified and five 4

existing sequences that had an increase in likelihood.

5 The new accident sequences were improper target 6

solution routing, damage to a TPS train, damage to the 7

process vessel vent system, Talk's interface, and back 8

flow of target solution to the IXP.

9 And the likelihood increase that was 10 evaluated by SHINE, there were heavy load drops on the 11 TPS, heavy load drops on an operating irradiation unit 12 or Talk cell, and a heavy load drop on the radioactive 13 liquid waste isolation enclosure super cell. And 14 then, of course, as the phases go in, as construction 15 is continued, you know, there's an increase in the 16 fire, the irradiation facility or the radioisotope 17 production facility.

18 Next slide, please. So how we started our 19 approach to this review is that we wanted the exact 20 same staff members to review the phased startup 21 approach that reviewed the full design. So for our 22 technical and safety review, the NRC staff reviewed 23 the information, the SHINE supplement, against 24 regulatory requirements, regulatory guidance and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

55 acceptance criteria, that I discussed earlier. Staff 1

evaluated the effect of the phased approach of startup 2

on the sufficiency of the facility descriptions, 3

design basis, facility operation, and SSCs, and as the 4

facility as a whole. And we also reviewed the kinds 5

and quantities of radioactive material expected to be 6

produced in the operation of the SHINE facility and 7

the means for controlling and limiting radioactive 8

exposures within 10 CFR Part 20.

9 We also reviewed the methods and 10 sufficiency of system level isolations for the 11 different phases just to ensure safe operation of 12 facility and health and safety of the workers and 13 public.

14 Next slide, please. Okay. We did perform 15 an audit. Right now, we're just finishing, just some 16 final touches on that is in draft form right now. We 17 can share that with members if requested. We're 18 hoping to have that issued here very soon.

19 I'll say that, early on in our review, we 20 had some areas of perceived risk significance in some 21 of those areas where the human system interfaces and 22 training of operators, because there will be a lot 23 going on in these different phases, that we wanted to 24 make sure, like the operators, you know, there are 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

56 minimal distractions to them while operating the 1

facility.

2 Tracy and Charlie discussed this earlier 3

on disabling and enabling instrumentation and control 4

inputs. Also, with construction, there will be 5

increased clean operations with heavy loads during 6

operation and also on radiological dose to workers on 7

completing construction. And what we looked at is if 8

there was a construction going on in an adjacent IU 9

cell, you know, what would those doses look like to 10 that individual in there.

11 Next slide, please. So 10 CFR 50.57, 12 which is issuance of operating license, it requires 13 that each license issued by the Commission to include 14 appropriate provisions with respect to uncompleted 15 items of constructions required to ensure that the 16 operation during the period of the completion of such 17 items will not endanger public health and safety. So 18 in their response to an RAI, SHINE did provide phased 19 specific listing of installation and functional 20 testing that was needed to support each phase of the 21 operation. And the staff is imposing a license 22 condition to ensure that the operation of these 23 subsequent phases will not commence until the 24 uncompleted items are completed and that NRC oversight 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

57 of completion of these uncompleted items is 1

maintained.

2 So next slide, please, is the actual 3

license condition that we're proposing. The first 4

part of this just points to the supplement submitted 5

by SHINE, and then the two conditions below talk 6

about, you know, 14 days prior to planned commencement 7

of operation of the next phase, that SHINE has to 8

notify the NRC in writing that all uncompleted items 9

of construction have been completed. And item B there 10 talks about SHINE providing updates to the NRC after 11 issuance of the operating license, which, you know, 12 would authorize phase one. Every six months, SHINE 13 needs to provide the NRC an update on the information 14 and the status of the schedule for completion of 15 uncompleted items of construction. And we could use 16 this information to inform our oversight inspection 17 activities for SHINE.

18 And last slide here, these are evaluations 19 and conclusions that SHINE did describe the design of 20 the systems and identified major features or 21 components affected by the proposed phase approach to 22 startup, also that the process is performed; operating 23 procedures and equipment; use of the facility; provide 24 reasonable assurance that they'll comply with Part 50 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

58 and Part 20 regulations and that the health and safety 1

of the public will be protected during the phased 2

approach to startup; and, 50.40, the issuance of the 3

operator license will not be inimical to the common 4

defense and security of health and safety of the 5

public and that the descriptions and discussions of 6

the SHINE systems affected by the approach are 7

sufficient to meet the applicable regulatory 8

requirements and acceptance criteria for issuance of 9

an operating license.

10 That's my last slide. Are there any 11 questions?

12 MEMBER HALNON: Yes, Michael. This is 13 Greg Halnon. Do you guys have a plan for how you're 14 going to do the oversight during this time frame?

15 There was some discussion whether Region III would be 16 doing it or Region II. Since you'll have operation 17 and construction going on at the same time, will there 18 be different oversight centers or --

19 MR. BALAZIK: Yes, Member Halnon. Right 20 now, Region II is the lead for the construction 21 activities at SHINE. Once we get into that pre-22 operational readiness, there's a combination of Region 23 II oversight activities and NRR oversight activities.

24 So office of NRR has the lead for the pre-operational 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

59 readiness.

1 Now, for these parts of construction, we 2

haven't figured out exactly who would have the lead on 3

these inspection activities and what the inspection 4

activities look at this time. So I can't give you a 5

definite answer who is going to have the lead on this.

6 MEMBER HALNON: Okay. I think, as you go 7

forward and figure that out, we'd be interested in at 8

least seeing the documents or some kind of plan. I'm 9

not sure that the Operations Subcommittee wants a 10 full-blown meeting or anything, but let's stay in 11 touch and, when you get that set, communicate it with 12 me.

13 MR. BALAZIK: Yes, sir. I got it.

14 Appreciate it. Any other questions?

15 CHAIRMAN BALLINGER:

This is Ron 16 Ballinger. With respect to that request, do you 17 anticipate the timing for that?

18 MR. BALAZIK: I think that would be based 19 on SHINE providing us the information when they would 20 be, you know, ready to move to the next phase. But --

21 CHAIRMAN BALLINGER: Okay. So that's long 22 after, long after we're done with the letter, right?

23 MR. BALAZIK: Long is a relative term. I 24 don't know if SHINE wants to chime in on their planned 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

60 schedule.

1 MS. RADEL: Yes, so this is Tracy Radel.

2 We're approximately a year or so out from substantial 3

completion, roughly, as far as receipt of the 4

operating license, you know, subsequent to that.

5 CHAIRMAN BALLINGER: I would consider that 6

long compared to December.

7 MR. BALAZIK: Yes, sir, I do agree with 8

that. Thank you, Tracy.

9 CHAIRMAN BALLINGER: Okay. So absent 10 further questions by members or consultants, we need 11 to now ask for public comment. If you are a member of 12 the public and you're listening and would like to make 13 a comment, please state your name and make your 14 comment, reminding, I think, that if you're on the 15 phone you have to use the star 6 procedure to get 16 access.

17 So are there members of the public out 18 there that would like to make a comment? Apparently 19 none.

20 Okay. So we are, more or less, at the end 21 of the presentations. I don't think we need a closed 22 session, so now I think we need to just open up the 23 discussion for any other comments or discussion points 24 that members would like to deal with. Deafening 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

61 silence. Okay.

1 MEMBER DIMITRIJEVIC: Ron, this is Vesna.

2 CHAIRMAN BALLINGER: Vesna, how are you?

3 MEMBER DIMITRIJEVIC: Good. How are you 4

doing?

5 CHAIRMAN BALLINGER: Your name is not on 6

this list for some reason.

7 MEMBER DIMITRIJEVIC: I don't know why.

8 I can see my name on the list.

9 CHAIRMAN BALLINGER: Okay, all right.

10 MEMBER DIMITRIJEVIC: I was thinking maybe 11 we can devote some short time on just discussing how 12 can we help you in writing this letter and do you have 13 some structure in mind, you know, so that we can get 14 ready for writing --

15 CHAIRMAN BALLINGER: Yes. I sent a note 16 out to the members probably late last night. The way 17 I see it, we now have, with the exception of two of 18 the memos, all of the memos may have ML numbers, and 19 so those are available. And my plan is to use those 20 memos as not only the starting point but the major 21 input for the letter and any other comments, which 22 I've asked people for -- from time to time, members 23 have sent paragraphs or such and such to me related to 24 what might be in the letter. Like I said last night, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

62 there are various vintages. So if there are members 1

that have additional comments or issues related to 2

what might be in the letter, then I'd appreciate those 3

because, come next week or starting this weekend, I'll 4

be putting together the draft letter.

5 Now, the format will be, unless I hear 6

something different, there are no showstoppers, no 7

buts, that would be in the letter that would require 8

response from the staff, I don't think. And so the 9

front-end of the letter, we already have some of that, 10 some of the background that we've seen before. And so 11 then the conclusion will be quite simple in words we 12 approve and then some minimal discussion that hits the 13 high points and then a referral because all of the 14 memos will be attached to the final letter. So what 15 it amounts to is a summary up-front and then the 16 detailed references also included in the letter.

17 So that's the general format, and I'd 18 appreciate comments from members related to that 19 because I'm going to start doing it tomorrow.

20 MEMBER DIMITRIJEVIC: So this was one of 21 my, actually, curiosities. Every writer has, you 22 know, comments or suggestions or conclusions in the 23 front. You don't plan to put those in the final 24 letter, you're just going to reference other letters?

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63 CHAIRMAN BALLINGER: No, no, I'm sorry.

1 I guess I wasn't detailed enough. There will be a 2

section after the results and the conclusions and 3

recommendation for sort of, I guess I would call it 4

general comments, I'm not sure I'd want to use the 5

word suggestions, that would contain the kinds of 6

things that we've had discussions of at the various 7

subcommittee meetings, and that's where input, the 8

little paragraphs and the like that we've asked people 9

to provide, would be very important.

10 So, yes, there will be, you know, again, 11 since we don't anticipate, at least right now, any 12 what I call showstoppers, the buts, that's just a for 13 information section, in effect.

14 MEMBER DIMITRIJEVIC: Yes. You know, I 15 was just thinking that these comments we have provided 16 throughout the sessions, some of them are different 17 types, you know. Like, for example, some are 18 suggestions, something we would like to see later, you 19 know. For example, Charlie had the comments on the 20 electrical system, which he asked for the, you know, 21 the changes. So I was sort of wondering because we're 22 having these different type of comments --

23 CHAIRMAN BALLINGER: Yes, we'll have to 24 reconcile --

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64 MEMBER DIMITRIJEVIC: -- define the 1

categories. I wasn't sure what's the best way to 2

organize them, you know.

3 CHAIRMAN BALLINGER: I'm sure that, during 4

our discussions of the draft, we'll get that all 5

reconciled.

6 MEMBER DIMITRIJEVIC: All right, okay. So 7

then next --

8 CHAIRMAN BALLINGER: We got to have a 9

strawman to shoot at first.

10 MEMBER MARCH-LEUBA: This is Jose. The 11 way I envisioned it was we would have all the memos, 12 the full memos, in the appendices.

13 CHAIRMAN BALLINGER: Yes, yes.

14 MEMBER MARCH-LEUBA: Any comments, any 15 recommendations, any conclusions that you would like 16 to see on the main body of the letter, on the area 17 responsible for the memo, it would be convenient for 18 Ron if you write two or three paragraphs that you'd 19 ask him to say this is the summary of what the memo 20 says that I think merits inclusion in the body of the 21 letter.

22 CHAIRMAN BALLINGER: Yes, that's, you 23 know, we've asked that question quite a few times and 24 asked for input, and we've gotten some input. But 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

65 we'll ask it again, yes. That would be very, very 1

helpful because, other than that, I will use the memos 2

themselves, which also contain these kinds of 3

comments. But it would be a lot easier if, now that 4

we've had the complete set of presentations, where, if 5

a member would like to provide a paragraph or so, that 6

would be very helpful. That's my story and I'm 7

sticking to it.

8 MEMBER BROWN: I had one question, Ron.

9 Is this meeting on the, whatever day it is, the 15th, 10 is that an in-person meeting, or are we going to be 11 trying to do this all day by virtual?

12 MEMBER REMPE: No, it's in person. We 13 decided that several months ago. Of course, if 14 someone wants to, they can still stay and do it 15 remotely, but there will be some folks in the room is 16 what we decided.

17 MEMBER BROWN: Okay. I was just trying to 18 confirm that that week was going to be an in-person 19 week. I wasn't at the meeting so --

20 CHAIRMAN BALLINGER: Yes, I think the 21 invitation was just sent out for anybody that wants to 22 do remote, but yes.

23 MEMBER BROWN: Yes, okay. That's all I 24 had.

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66 MEMBER HALNON: So, Ron, this is Greg.

1 Now I can kind of understand why you asked me to 2

revise one of the memos.

3 CHAIRMAN BALLINGER: Oh, wait a minute, 4

hold on a minute. Revising the memos, no, please.

5 MEMBER HALNON: Well, I mean, it's not the 6

actual issues, it's what we expected for the follow-7 up. If we don't, you know, sometimes time heals some 8

of these comments and then --

9 CHAIRMAN BALLINGER: Right, yes.

10 MEMBER HALNON: -- come up that don't 11 really warrant anymore time being spent on it.

12 CHAIRMAN BALLINGER: Yes, yes.

13 MEMBER HALNON: I assume you'd like to 14 make sure the memos are up to date from the standpoint 15 of what we want follow-up and what we don't, kind of 16 to Vesna's question, what --

17 CHAIRMAN BALLINGER: Well, I think now I'd 18 have to ask Larry or Chris about this. I think those 19 memos now have ML numbers, and so those are kind of in 20 violet unless something else, unless we can -- I don't 21 know what we would do if somebody wants to change a 22 memo.

23 MEMBER REMPE: This is Joy. I mean, Larry 24 and Chris can give you ultimate, but I would say that, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

67 no, those were a snapshot in time, and perhaps the 1

letter can say these were a snapshot in time and 2

these, you know, this letter has our final comments 3

that we want to mention about this review.

4 CHAIRMAN BALLINGER: Yes, that's --

5 MEMBER REMPE: I think that's what we've 6

done in the past.

7 CHAIRMAN BALLINGER: -- you know, the sort 8

of one-or two-paragraph vehicle is a way to do that.

9 MEMBER HALNON: Okay. And that was where 10 I was going with it. So in a paragraph, that should 11 be the endpoint. I mean, that's finally where our 12 mind is at relative to any issues that we have, both 13 specific and general.

14 CHAIRMAN BALLINGER: Yes. A lot of these 15 chapters are sort of interwoven, if you will, and so 16 it's entirely appropriate to have a different outlook 17 once you've heard them all.

18 MEMBER HALNON: Okay. And --

19 MEMBER DIMITRIJEVIC: So, Ron, when you 20 said now, we definitely don't have showstoppers, but 21 if there's suggestions for the changes in the chapter, 22 like Charlie did on electrical, then what's happening 23 with those?

24 CHAIRMAN BALLINGER: Well, if they're 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

68 suggestions, again, I need to make sure I'm not 1

violating a rule, if they're suggestions, the 2

applicant can either say, okay, we'll do that or, no, 3

we won't do that. That will be at the staff's or the 4

applicant's discretion. People can correct me if I'm 5

wrong.

6 MEMBER REMPE: Well, I would point out 7

that we only provide suggestions to the staff, right?

8 CHAIRMAN BALLINGER: Yes, yes.

9 MEMBER REMPE: I mean, we can make 10 comments to the applicant, but our charter is to help 11 the staff review.

12 CHAIRMAN BALLINGER: Yes, yes, yes.

13 MEMBER BROWN: If there's anything we want 14 a response from the staff for, we ought to say it in 15 your memo, not in one of the enclosures. It ought to 16 be brought up to the memo and we ask for a staff 17 response to our memo; that's all.

18 CHAIRMAN BALLINGER: And I think that 19 actually has happened for many of them.

20 MEMBER BROWN: Yes, that's the way we've 21 done all of our letters, so we sent a letter out, a 22 report, and we ask for a response or we don't. If we 23 want a response, then we get it. And if we've got 24 suggestions, we ask for a response.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

69 CHAIRMAN BALLINGER: Yes, yes.

1 MEMBER BROWN: This is not complicated.

2 CHAIRMAN BALLINGER: No, hopefully.

3 MEMBER HALNON: And the purpose of the 4

final memo is to give the Commission our overall 5

impression of the license application; is that 6

correct?

7 MEMBER REMPE: That's true, except it's a 8

letter, it's not a memo.

9 CHAIRMAN BALLINGER: It's a letter, it's 10 a letter.

11 MEMBER BROWN: It's a letter report.

12 MEMBER HALNON: Yes, that's words. But 13 the letter report.

14 MEMBER BROWN: It's a regular letter 15 report.

16 MEMBER HALNON: Yes, okay.

17 MEMBER REMPE: But I'm bean-counting 18 memos, Ron. You've said we've had all but a couple.

19 I know they're posted out there, but we're going go 20 actually go through how many? Isn't it like going to 21 be four or five, depending on what's happening with 22 this space --

23 CHAIRMAN BALLINGER: No, two or three.

24 MR. BROWN: Four. Four memos are left:

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

70 cyber, life cycle, I&C, and help me, Jose. Oh, tech 1

specs, tech specs.

2 CHAIRMAN BALLINGER: Yes.

3 MEMBER REMPE: Isn't there a Chapter 7 4

also or something?

5 MR. BROWN: Yes, I&C. That's four.

6 CHAIRMAN BALLINGER: Yes. And there's 7

potentially a fifth, but I haven't decided, and that 8

is related to the phase approach. I waited until 9

after the presentations, and I'm going to think about 10 that a little bit, and it would be nice to hear from 11 the members on this. I'm leaning towards not having 12 a separate memo on the phased approach but including 13 discussion in what we would call the preamble and some 14 of the discussion in the letter because, in effect, 15 what the phased approach is is just a different method 16 of construction. Maybe I'm reading things wrong, but 17 it would be nice to hear from other members on what 18 their opinion would be.

19 MEMBER HALNON: It's not all that 20 different than what's going on in Vogtle or any other 21 multi-unit plant, so I don't see anything special 22 about it. It's just a matter of making sure that they 23 complied.

24 CHAIRMAN BALLINGER: Yes, yes, that's what 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

71 I'm coming down to, but there are other opinions 1

probably. Oh, Scott Moore. Scott, you've raised your 2

hand.

3 MR. MOORE: Yes, Chairman Ballinger.

4 Previously, the staff had asked for the Committee's 5

final report on SHINE by the end of December. Are 6

they still looking for the report on that same time 7

line?

8 CHAIRMAN BALLINGER: I haven't heard 9

anything different, but we have an informal after this 10 meeting, and I'm sure we can confirm that. But I 11 think, Josh or Michael, can you confirm that?

12 MR.

BORROMEO:

That seems like a

13 reasonable time, but we can discuss if there's 14 resource issues at our informal afterwards.

15 MEMBER REMPE: This is Joy. And what 16 would be a reason for us to delay? We've gotten all 17 the information we need, and we have planned our 18 schedule, and so I wouldn't, even if the staff 19 decides, well, we can wait until, it would be February 20 if we don't do it in December because January we don't 21 have a full Committee meeting. So is there a reason 22 that we wouldn't want to try and meet that deadline, 23 Scott?

24 MR. MOORE: No, and I wasn't suggesting 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

72 that. The only -- I just wanted to confirm that that 1

is when the staff needed the final report. And the 2

only reason I'd say that the Committee should delay 3

would be if there's new information or if the staff 4

hasn't responded to anything yet, and I'm not aware of 5

any of that.

6 CHAIRMAN BALLINGER: Right. So unless 7

death or plague occurs, December is it.

8 MEMBER REMPE: You know, with all the 9

pandemic stuff, don't say plague.

10 CHAIRMAN BALLINGER:

I didn't say 11 pandemic. I said plague.

12 (Laughter.)

13 MEMBER REMPE: Never mind.

14 CHAIRMAN BALLINGER: Okay. So we've had 15 our discussion. Once again, I'd like to thank the 16 staff and the applicant and our staff actually for 17 seeing this through, and we're approaching the end, 18 and I'm looking forward with some fear and trepidation 19 to the November meeting where we have a discussion.

20 So if there aren't any further questions, 21 I think we need to close off this meeting. But, 22 Chris, should you and I and --

23 MR. BROWN: I have a separate invite.

24 Check your --

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

73 CHAIRMAN BALLINGER: Oh, it's a separate 1

invite. Okay.

2 MR. BROWN: Yes.

3 CHAIRMAN BALLINGER: All right. We're 4

good.

5 MR. BURKHART: Hey, Ron, this is Larry.

6 Do you want to have an opportunity for public comment?

7 CHAIRMAN BALLINGER: Did that.

8 MR. BURKHART: Okay, all right. Sorry.

9 CHAIRMAN BALLINGER: Did that and didn't 10 hear anything. Okay. So thanks again everybody, and 11 we'll see Josh and whoever in a few minutes.

12 (Whereupon, the above-entitled matter went 13 off the record at 11:16 a.m.)

14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com

© SHINE Technologies, LLC 1

© SHINE Technologies, LLC Process Integrated Control System (PICS)

RYAN MYERS, I&C ENGINEER

© SHINE Technologies, LLC 2 PICS Overview PICS Network Architecture and Security PICS Interfaces with Safety-Related Systems PICS Vendor-Provided Nonsafety-Related Control System Interfaces PICS Workstations and Network Access Outline

© SHINE Technologies, LLC 3 PICS Overview

© SHINE Technologies, LLC 4 PICS is a nonsafety-related digital control system whose principal functions are to control and monitor facility systems and components within the irradiation facility (IF) and radioisotope production facility (RPF).

A portion of the PICS supports the main control board (MCB) and operator workstations in the facility control room (FCR) by receiving operator commands and collecting and transmitting facility information to the operators.

The PICS system network routes signals to the main distribution switch located in the server room.

Information from the FCR, remote input/output (RIO) cabinets, remote human machine interface (HMI) panels, programmable logic controllers (PLCs), vendor-provided control systems, and virtual machines communicate through the main distribution switch with a combination of copper and fiber optic cabling.

PICS Overview

© SHINE Technologies, LLC 5 PICS has no connection to the internet and no Wi-Fi capable devices.

The PICS manufacturing control network (MCN) is segregated from the SHINE business network.

The PICS PLC communications on the MCN is split into 10 separate virtual local area networks (VLANs), one for each of the 10 PICS PLCs.

PICS cabinets are locked requiring a key administratively controlled by Operations personnel.

PICS server room which houses the PICS ControlLogix PLCs and servers, has restricted access.

Unused ports (e.g., Ethernet, USB) are physically blocked or electronically disabled.

o The port keys are controlled by Operations personnel.

Ethernet/IP with CIP (common industrial protocol) is the communication protocol used for communication between the PICS PLCs, RIO racks, servers, workstations, and thin clients.

o CIP is widely used to secure plant networks.

Electronic access to PICS is not available from outside the site.

PICS Network Architecture and Security

© SHINE Technologies, LLC 6 The target solution vessel reactivity protection system (TRPS) and engineered safety features actuation system (ESFAS) provide signals to PICS via a one-way isolated nonsafety-related Modbus gateway.

PICS normally has manual electrically isolated control of TRPS/ESFAS controlled components.

PICS provides valve and damper position indication to TRPS/ESFAS for verification of completion of protective function through electrically isolated relay outputs.

PICS provides mode transition signals to TRPS, when manually initiated by the operator.

PICS provides signals to TRPS/ESFAS to reposition components, when manually initiated by the operator and the main control board enable nonsafety switch is in the enable position.

Both the mode transition and reposition request signals from PICS are encoded using a bitstream method with a pattern of discrete relay outputs that are then translated by TRPS/ESFAS.

PICS is designed so that its failures cannot directly or indirectly impact the ability of the TRPS or ESFAS to perform its safety functions.

PICS Interfaces with Safety-Related Systems

© SHINE Technologies, LLC 7 PICS interfaces with several vendor-provided nonsafety-related control systems which consist of the neutron driver assembly system (NDAS) controls, supercell controls, and various auxiliary control systems.

There are no internet connected or Wi-Fi enabled devices for the vendor-provided equipment.

Like PICS, the vendor-provided nonsafety-related control systems do not allow remote access and include the capability to disable unneeded networks, communication ports, and removable media drives, or provide engineered barriers.

Vendor-provided nonsafety-related control systems communicate with PICS via Ethernet, Modbus, or other industry standard digital communication protocols.

Many of the PICS vendor equipment interfaces communicate with CIP over Ethernet/IP, utilizing the protocols built in safety features.

PICS Vendor-Provided Nonsafety-Related Control System Interfaces

© SHINE Technologies, LLC 8 PICS Modbus connections to vendor-provided control systems use custom configured gateways to only read from or write to vendor-approved addresses.

o The plants power supply systems interface with PICS via Modbus.

The building automation system (BAS) provides control for many of the ventilation and facility systems.

o BAS provides information to PICS for monitoring only using BACnet/IP, a building automation and HVAC industry standard.

PICS communications with vendor-supplied supercell and radioactive liquid waste immobilization (RLWI) system PLCs are read-only communications used for monitoring purposes only.

The NDAS control system receives permissive signals from the PICS to allow or disable use of the system and provides information to PICS for monitoring.

PICS monitors vendor-supplied nonsafety-related radiation monitors throughout the plant.

PICS Vendor-Provided Nonsafety-Related Control System Interfaces

© SHINE Technologies, LLC 9 Users who require access to the FactoryTalk View (FTV) Site Edition (SE) Supervisory Control and Data Acquisition (SCADA) system will have individual accounts created on the manufacturing domain.

o Users are required to set a password for their manufacturing domain account.

When users log in to PICS with their unique credentials, their accounts authenticate against the manufacturing domain.

o When no user is logged in, graphics and alarms are view-only, with no control/interactive functions available.

o Domain users will only be assigned to one domain group.

The five domain groups are Maintenance, Operator, Supervisor, Administrator, or Quality.

In conjunction with domain groups, users will be assigned to security areas which will coincide with various equipment areas in the SHINE production facility.

o This will allow SHINE to give certain user accounts limited control of PICS equipment.

o Facility control room operators and supervisors will be assigned to all security areas.

PICS Workstations and Network Access

© SHINE Technologies, LLC 10 Users will not be able to log in or operate remote HMI locations without being granted access by the facility control room supervisor.

o The facility control room supervisor can take back control of the PICS equipment at any time.

In the event of a power outage, each operator workstation has a local uninterruptable power supply (UPS) capable of supplying 10 minutes of backup power, by which time, the standby generator system (SGS) will be fully engaged providing power o The operator workstation thin client sessions are not lost with a local loss of power, they continue to run on the Stratus fault tolerant server (ftServer) in the server room.

PICS Workstations and Network Access

© SHINE Technologies, LLC 1

© SHINE Technologies, LLC Phased Approach to SHINE Facility Operations TRACY RADEL, VICE PRESIDENT OF ENGINEERING

© SHINE Technologies, LLC 2 Philosophy Phase Descriptions Irradiation Facility Systems Radioisotope Production Facility Systems Instrumentation and Control Systems Electrical Power Systems Auxiliary Systems Accident Analysis Outline

© SHINE Technologies, LLC 3

Purpose:

Meet the national need for Mo-99 production as soon as possible while also ensuring all requirements related to public health and safety are met o Provide flexibility for challenges that may arise during procurement, installation, and testing Key considerations:

o Ensure that all design criteria and safety functions can be met o Simplify process boundary isolation strategy o Simplify confinement boundary isolation strategy o Minimize impact on operating portions of the facility Overall Philosophy

© SHINE Technologies, LLC 4 The SHINE approach to phased startup operations does not inherently affect how SHINE is approaching procurement and installation o Equipment for all eight irradiation units (IUs) being procured at the same time o Fabrication for most equipment is naturally being done in sets or batches, resulting in staggered delivery o As challenges are encountered in the fabrication process, equipment for Phase 1 will be prioritized Equipment will be installed as soon as possible once it is received on site Procurement and Installation Philosophy

© SHINE Technologies, LLC 5 Phase 1:

o Facility structure (FSTR) and nitrogen purge system (N2PS) structure o IUs 1 and 2, including IU-specific instances of the subcritical assembly system (SCAS), neutron flux detection system (NFDS), target solution vessel (TSV) off-gas system (TOGS), primary closed loop cooling system (PCLS), light water pool system (LWPS), and radiological ventilation zone 1 (RVZ1) equipment located in the cooling room o Tritium purification system (TPS) train A o Auxiliary and support systems, with the exception of IU-specific instances of PCLS, LWPS, and RVZ1 equipment located in the cooling room o Radioisotope production facility (RPF) systems, with the exception of iodine and xenon purification and packaging (IXP) and radioactive liquid waste immobilization (RLWI) selective removal capabilities Phase Descriptions

© SHINE Technologies, LLC 6 Phase 2:

o IUs 3, 4, and 5, including IU-specific instances of the SCAS, NFDS, TOGS, PCLS, LWPS, and RVZ1 equipment located in the cooling room o TPS train B Phase 3:

o IUs 6, 7, and 8, including IU-specific instances of the SCAS, NFDS, TOGS, PCLS, LWPS, and RVZ1 equipment located in the cooling room o TPS train C o RLWI selective removal capability o Material staging building Phase 4:

o IXP capability Phase Descriptions

© SHINE Technologies, LLC 7 IUs are designed and operated at the unit level.

o Each IU has unit-specific instances of the SCAS, NDAS, light water pool, and irradiation cell biological shield (ICBS), and each IU is supported by unit-specific instances of the PCLS and TOGS.

o Support system and process line interfaces with the IUs are isolated to support phased startup operation (i.e., interfaces with IUs 3 through 8 are isolated during Phase 1 operation, interfaces with IUs 6 through 8 are isolated during Phase 2 operation).

Irradiation Facility Systems IRRADIATION UNITS

© SHINE Technologies, LLC 8 The TPS consists of three independent trains and each TPS train supports specific NDAS units.

o Each TPS train includes independent train specific instances of the isotope separation system (Thermal Cycling Adsorption Process [TCAP]), TPS-NDAS interface lines, secondary enclosure cleanup (SEC),

vacuum/impurity treatment subsystem (Vac/ITS), NDAS SEC, and TPS glovebox.

o The tritium confinement boundary for each TPS train (including the TPS glovebox, SEC, isolation valves, TPS-NDAS interface lines, and tubing up to isolation valves) is independent and isolated from the other TPS trains; no portion of the tritium confinement boundary is shared between TPS trains.

o Isolation is provided at TPS interface points to facility systems to allow TPS trains to be connected and commissioned without impacting operating TPS trains.

Irradiation Facility Systems TRITIUM PURIFICATION SYSTEM TRAINS

© SHINE Technologies, LLC 9 RPF systems are installed to support Phase 1 operations, with the exception of the IXP system and the RLWI selective removal capability.

During Phase 1 through Phase 3 operations, the IXP system is not installed within the IXP hot cell, and the IXP hot cell is isolated from the supercell confinement boundary.

o The interfacing process and supporting system connections to the IXP system are isolated during Phase 1 through Phase 3.

The capability of the RLWI system to remove classification-driving isotopes is not available during Phase 1 and Phase 2 operations.

o During Phase 1 and Phase 2, liquid waste is stored in the subgrade radioactive liquid waste storage (RLWS) system tanks prior to transfer to RLWI in order to maximize the decay time and limit the volume of solidified waste requiring disposal.

o Waste solidified during Phase 1 and Phase 2 may have higher dose rates and higher waste classifications than wastes solidified during Phase 3 and Phase 4.

Radioisotope Production Facility Systems

© SHINE Technologies, LLC 10 During phased startup operations, the instrumentation and control (I&C) systems are installed to the extent practicable given the extent of equipment installation.

IU-specific instances of the TSV reactivity protection system (TRPS) are brought online with the associated IU in the applicable phases.

o The nine TRPS cabinets are installed in the facility control room (FCR) prior to Phase 1 operations but are brought into operation with the corresponding IU phasing as described in Chapter 1.

The engineered safety features actuation system (ESFAS) is installed to support Phase 1 operations.

o During phased startup operations, inputs to the ESFAS for equipment that is not required to be operable are disabled using the maintenance workstation (MWS).

o These disabled inputs are restored and verified to be operable prior to entering the technical specification mode of applicability associated with the given input.

Instrumentation and Control Systems

© SHINE Technologies, LLC 11 IU-specific instances of the neutron flux detection system (NFDS) are brought online with the associated IU in the applicable phases.

The safety-related process radiation monitors are installed to the extent practicable given the extent of equipment installation.

o Safety-related process radiation monitors associated with individual IUs (inputs to TRPS) and TPS trains (inputs to ESFAS) are installed during the phase associated with that IU or TPS train.

o Safety-related process radiation monitors associated with the IXP cell (input to ESFAS) are installed prior to Phase 4 operations.

Process integrated control system (PICS) hardware (i.e., cabinets, power supplies, controllers, programmable logic controllers [PLCs]) is installed prior to Phase 1 operations, with the exception of hardware associated with TPS trains B and C.

o PICS monitoring and controls associated with equipment that is not yet installed or not yet operable to support Phase 1 operations are tested and placed in operation as required for a given phase.

Instrumentation and Control Systems

© SHINE Technologies, LLC 12 The normal electrical power supply system (NPSS) and uninterruptible electrical power supply system (UPSS) are installed in full to support Phase 1 operations.

o Loads on the NPSS and UPSS that are not yet installed or not yet operable in Phases 1, 2, or 3 have the associated isolation device removed or placed in an out-of-service condition.

o Cabling associated with equipment that is not yet installed or not yet operable for a given phase is installed to the extent practicable with the power removed at the associated panel or load.

The nonsafety-related standby generator system (SGS) is installed in full to support Phase 1 operations.

Electrical Power Systems

© SHINE Technologies, LLC 13 RVZ1 recirculating subsystem (RVZ1r) units support individual IU and TOGS cells and are installed with the corresponding IU.

Portions of the RVZ1 exhaust subsystem (RVZ1e) located in the cooling rooms are installed with the corresponding IU.

Supply lines from auxiliary systems include manual isolation valves and blind flange or caps to support phased startup operations.

Auxiliary systems are designed to handle the variable loads without modifications.

Auxiliary Systems

© SHINE Technologies, LLC 14 A hazard evaluation was performed to identify new or different accident scenarios, including changes to likelihood or consequences of existing accident scenarios.

The likelihood and consequences for these new or different accident scenarios were then evaluated and compared to the risk matrix and safety-related controls were applied to prevent or mitigate the accident scenario, in a method consistent with that described in Chapter 13a2 of the FSAR.

Phased startup operations do not result in any new accident categories or increased consequences from existing accident scenarios.

Five new accident sequences were identified, and five existing accident scenarios were reevaluated with increased likelihoods.

Four new credited engineered controls and three new credited administrative controls are added during phased startup operations to prevent the new or different accident scenarios.

Accident Analysis

Advisory Committee on Reactor Safeguards SHINE Medical Technologies Operating License Application Chapter 7 - Instrumentation and Controls PICS October 21, 2022 Norbert Carte Office of Nuclear Reactor Regulation

I&C Technical Review Team

Guidance and Acceptance Criteria

  • NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996;
  • NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996;
  • Final Interim Staff Guidance (ISG) Augmenting NUREG-1537, Part 1 and Part 2, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors 3

SAFETY EVALUATION OVERVIEW 4

Chapter 7 Safety Evaluation

  • Current Scope

- PICS

  • Previous Briefings

- I&C Design Criteria

- Highly integrated Protection System (HIPS)

- Target solution vessel reactivity protection system (TRPS)

  • neutron flux detection system (NFDS)

- Engineered safety features actuation system (ESFAS )

  • radiation area monitoring system (RMS) 5

PICS Description

- 7.3, Process Integrated Control System

- 7.6, Control Console and Display Instruments

  • SER Section 7.4.3, Process Integrated Control System
  • SHINE Facility

- Two Distinct Parts (IF & RPF)

- One Control Room & one PICS (with many parts)

  • Protection Systems (i.e., TRPS & ESFAS) & Control Systems (i.e., PICS) are:

- Independent

- Diverse 6

PICS Systems 7

Gateway Communications Architecture 8

Background Information - Main Control Board 9

PICS REVIEW 10

Layered Approach to Safety

  • Design Criteria - Performance Objectives

- Provide criterion for achieving reasonable assurance of adequate safety

- Some are more safety significant than others

  • Design Bases - Functions and Values

- Events Described in other FSAR Chapters

- Analysis Demonstrates Misbehavior of DB is addressed

- Variables Monitored & Functions Performed

- Setpoints and Response Times (Analytic Values) 11

PICS -Design Criteria in Context

  • FSAR Design Criteria for PICS

- SHINE facility design criteria: 3,6, & 13

- PICS Criteria: 1-26

- SHINE facility design criteria for independence of TRPS &

ESFAS from PICS are imposed on TRPS & ESFAS

- SHINE facility design criteria 14, 16, & 18

  • Staff evaluated PICS against Design Criteria

- SHINE facility design criterion 3,6, & 13

- PICS Criterion 1-10 12

PICS -Design Criteria in Context

  • NRC review focus(given preceding context):

- PICS equipment failures analyzed to ensure:

Effects are bounded by events analyzed in safety analysis, see FSAR Section 7.3.2.2.4, Effects of Control System Operation/Failures

- PICS Independent from TRPS/ESFAS

  • Description in FSAR Section 7.3.1.3.11, Target Solution Vessel Reactivity Protection System and Engineered Safety Features Actuation System
  • Description in FSAR Section 7.3.2.2.4, Effects of Control System Operation/Failures
  • SHINE facility design criteria 14, 16, & 18 (imposed on TRPS & ESFAS) 13

PICS - Design Bases

  • FSAR Section 7.3.1, System Description

- Has subsection for each: IU & RPF

- Each has subsections for each system controlled, which describes applicable PICS functionality:

  • Variables Monitored and Alarmed
  • Control Functions
  • Interlocks and Permissives 14

Staff Evaluation of PICS

  • Based on its review of the information provided, the NRC staff concludes the design of the PICS meets the applicable design acceptance criteria in Section 7.3 of NUREG-1537, Part 2.
  • Based on the information reviewed, the NRC staff concludes that SHINE established the necessary design, fabrication, construction, testing, and performance requirements for the PICS to provide reasonable assurance that the facility be operated without undue risk to the health and safety of the public.

15

Questions 16

BACKGROUND 17

Acronyms APL actuation and priority logic (see HIPS TR)

ASAI application specific action item (see HIPS TR)

BF3 boron trifluoride BIST built-in self-test (see HIPS TR)

CAAS criticality accident alarm system CAMS continuous air monitoring system CCF common cause failure CDA critical digital asset CM communication modules (a HIPS module)

COTS commercial off-the-shelf CTB calibration and test bus (see HIPS TR)

EIM equipment interface module (a HIPS module)

EMI electromagnetic interference 18

Acronyms ESFAS engineered safety features actuation system FAT factory acceptance test FCR facility control room FDCS facility data and communications system FPGA field programmable gate array (see HIPS TR)

HIPS highly integrated protection system (see HIPS TR)

HVPS high voltage power supply HW-SM hardwired submodule (a HIPS module)

HWM hardwired module (a HIPS module)

I&C instrumentation and control IEEE Institute of Electrical and Electronic Engineers IF irradiation facility 19

Acronyms ISG interim staff guidance ISM input submodule (a HIPS module)

IU irradiation unit MI-CM monitoring and indication communication module (see HIPS TR)

MIB monitoring and indication bus (see HIPS TR)

MWS maintenance workstation (see HIPS TR)

NDAS neutron driver assembly system NFDS neutron flux detection system NPSS normal electrical power supply system NVM nonvolatile memory (see HIPS TR)

OOS out of service(see HIPS TR)

PDC Principal Design Criteria PICS process integrated control system 20

Acronyms PLDS programmable logic design specification PLRS programmable logic requirements specification QA quality assurance RAMS radiation area monitoring system RCA radiologically controlled area RDS radioactive drain system RFI radio-frequency interference RISM remote input submodule (a HIPS module)

RVZ1 radiological ventilation zone 1 RVZ1e radiological ventilation zone 1 exhaust subsystem RVZ1r radiological ventilation zone 1 recirculating subsystem RX receiver (Figure 7.1-x)

SASS subcritical assembly support structure SBM scheduling and bypass modules (a HIPS module) 21

Acronyms SBVM scheduling, bypass, and voting modules (a HIPS module)

SCAS subcritical assembly system SDB1 safety data bus 1 (see HIPS TR)

SDB2 safety data bus 2 (see HIPS TR)

SDB3 safety data bus 3 (see HIPS TR)

SDE secure development environment (see HIPS TR)

SFM safety function module (a HIPS module)

SOV solenoid operated valve SR safety-related SRM stack release monitor SRMS stack release monitoring system SVM scheduling and voting module (a HIPS module)

SyRS system requirements specification 22

Acronyms TMR triple modular redundant TOGS TSV off-gas system TPS tritium purification system TR topical report TRPS target solution vessel reactivity protection system TSPS target solution preparation system TSSS target solution storage system TSV target solution vessel TX transmitter (Figure 7.1-x)

UPSS uninterruptible electrical power supply system V&V verification & validation VTS vacuum transfer system 23

Advisory Committee on Reactor Safeguards SHINE Medical Technologies, LLC Operating License Application Appendix A - Phased Approach to Startup Michael Balazik Project Manager/Inspector Office of Nuclear Reactor Regulation October 21, 2022

Regulatory Basis

  • Regulatory Requirements

10 CFR 50.34, Contents of applications; technical information

10 CFR 50.40, Common standards

10 CFR 50.57, Issuance of operating license 2

Guidance and Acceptance Criteria

  • NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, issued February 1996;
  • NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, issued February 1996;
  • Final Interim Staff Guidance (ISG) Augmenting NUREG-1537, Part 1 and Part 2, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors 3

Summary of Application

  • On January 27, 2022, SHINE supplemented the FSAR to describe a four-phase approach to startup operations.
  • Phased completion is staggered over a few years and planned for completion in 2025.
  • In the supplement, SHINE describes the technical impacts and information differences for each chapter of the full-design facility FSAR.
  • SHINE identifies equipment isolation points and methods for each phase.
  • SHINE FSAR Chapters 4, Irradiation Unit and Radioisotope Production Facility Description, 7, Instrumentation and Control Systems, 9, Auxiliary Systems, and 13, Accident Analysis, are most impacted.

4

Summary of Application (continued)

  • Irradiation units (IU) are designed and operated independently (unit specific equipment).
  • Tritium Purification System (TPS) consists of three independent trains to support IU operation.
  • Except for the iodine and xenon purification/packaging (IXP) system and the radioactive liquid waste isolation (RWLI) selective removal capability, all systems for the Radioisotope Production Facility are installed to support Phase 1 operations.
  • Instrumentation and Control Systems are IU specific (TRPS), or inputs are disabled (ESFAS and PICS) 5

Summary of Application (continued)

  • Five new accident sequences were identified, and five existing accident sequences had an increase in likelihood
  • New accident sequences Improper target solution routing (Uninstalled IU or IXP)

Damage to the TPS train Damage to the process vessel vent system(PVVS)/TOGS interface Backflow of target solution to the IXP

  • Likelihood increase Heavy load drop on the TPS Heavy load drop on an operating IU or TOGS cell Heavy load drop on the RLWI enclosure or supercell Fire in the irradiation facility or radioisotope production facility 6

Staff Evaluation

  • The same NRC staff that reviewed the full-design FSAR Chapter reviewed the same chapter in the SHINE Supplement (Phased Approach to Startup)
  • Evaluated the effect on the sufficiency of the SHINE facility description and the design bases, the limits on facility operation, and the safety analysis of the structures, systems, and components (SSCs) and of the facility as a whole as presented in the SHINE FSAR.
  • Reviewed the kinds and quantities of radioactive materials expected to be produced in the operation of the SHINE facility and the means for controlling and limiting radioactive effluents and radiation exposures.
  • Reviewed the methods and sufficiency of system-level isolations for the different phases to ensure safe operation of the facility and to ensure health and safety of the workers and public.

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Staff Evaluation (continued)

  • The NRC staff audited information supporting the phased approach to startup.
  • Initial areas of perceived risk significance for phased approach to startup Human system interfaces/training of operators Disabling/enabling instrumentation and control inputs Increase crane operation with heavy loads during operation Radiological dose to workers completing construction 8

Phased Startup Operation License Condition 10 CFR 50.57(b) requires each operating license issued by the Commission to include appropriate provisions with respect to uncompleted items of construction and such limitations or conditions as are required to ensure that operation during the period of the completion of such items will not endanger public health and safety.

SHINE provided a phase-specific listing of installation and functional testing activities required to support operation of Phase 2, Phase 3, and Phase 4.

NRC staff is imposing a license condition to ensure that the operation of the subsequent phases of the SHINE facility will not be commenced until the associated uncompleted items of construction have been completed and that appropriate NRC oversight of the completion of the uncompleted items of construction is maintained.

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Phased Startup Operation License Condition (cont.)

License Condition is as follow:

The Licensee shall conduct activities for startup of facility operations in Phases, as described in SHINE Technologies, LLC Application for an Operating License Supplement No. 31, Enclosure 3, Phased Startup Operations Application Supplement, dated September 28, 2022 (ADAMS Accession Nos. ML22271A963 and ML22271A966), as amended. Operation of Phase 2 or of any subsequent Phase shall not commence prior to satisfaction of conditions (a) and (b) below:

a)

No later than 14 days before the planned commencement of operation of Phase 2, and thereafter no later than 14 days before the planned commencement of operation of each subsequent phase, the Licensee shall notify the NRC in writing that all uncompleted items of construction related to that Phase have been completed.

b)

Prior to the operation of Phase 4, the Licensee shall provide to the NRC in writing, six months after the issuance of this operating license and every six months thereafter, information on the status and schedule for completion of uncompleted items of construction.

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Evaluation Findings and Conclusions SHINE described the design of the systems and identified the major features or components affected by the proposed phased approach to startup for the protection of the health and safety of the public.

The processes to be performed, the operating procedures, the facility and equipment, the use of the facility, and other TSs, provide reasonable assurance that the applicant will comply with the regulations in 10 CFR Part 50 and 10 CFR Part 20 and that the health and safety of the public will be protected during the phased approach to startup.

The issuance of an operating license for the facility would not be inimical to the common defense and security or to the health and safety of the public.

The NRC staff finds that the descriptions and discussions of SHINEs systems as affected by the phased approach to startup are sufficient and meet the applicable regulatory requirements and guidance and acceptance criteria for the issuance of an operating license.

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