ML20345A277
| ML20345A277 | |
| Person / Time | |
|---|---|
| Issue date: | 11/04/2020 |
| From: | Charles Brown Advisory Committee on Reactor Safeguards |
| To: | |
| Brown, C, ACRS | |
| References | |
| NRC-1208 | |
| Download: ML20345A277 (99) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Advisory Committee on Reactor Safeguards Non-Power Production and Utilization Facilities Subcommittee: Open Session Docket Number:
(n/a)
Location:
teleconference Date:
Wednesday, November 4, 2020 Work O rder No.: NRC-1208 Pages 1-63 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (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
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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
2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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ADVISORY COMMITTEE ON REACTOR SAFEGUARDS (ACRS)
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NON-POWER PRODUCTION AND UTILIZATION FACILITIES SUBCOMMITTEE
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WEDNESDAY NOVEMBER 4, 2020
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The Subcommittee met via Teleconference, at 9:30 a.m. EST, Ronald G. Ballinger, Chairman, presiding.
COMMITTEE MEMBERS:
RONALD G. BALLINGER, Chairman DENNIS BLEY, Member CHARLES H. BROWN, JR. Member VESNA B. DIMITRIJEVIC, Member WALTER L. KIRCHNER, Member JOSE MARCH-LEUBA, Chairman DAVID A. PETTI, Member JOY L. REMPE, Member MATTHEW W. SUNSERI, Member
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 ACRS CONSULTANT:
STEPHEN SCHULTZ DESIGNATED FEDERAL OFFICIAL:
CHRISTOPHER BROWN DEREK WIDMAYER ALSO PRESENT:
STEVEN LYNCH, NRR TRACY RADEL, SHINE Medical Technologies JIM COSTEDIO, SHINE Medical Technologies JON DELVENTHAL, SHINE Medical Technologies CATHERINE KOLB, SHINE Medical Technologies JON OLVERA, SHINE Medical Technologies JEFFREY BARTELME, SHINE Medical Technologies
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 C-O-N-T-E-N-T-S PAGE Opening Remarks and Objectives by Ronald Ballinger, ACRS Chairman 6
Staff Opening Remarks by Steven Lynch, NRR 9
Overview of SHINE Medical Isotope Production Facility, opening remarks by Jim Costedio 10 Overview of SHINE Medical Isotope Production Facility by Tracy Radel 11 Public Comments 19 Break for closed session 19 Approach to Review of SHINE Operating License Application By Steven Lynch, NRR 20 Closing Remarks By Ronald Ballinger, ACRS Chairman 62
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P R O C E E D I N G S 1
(9:30 a.m.)
2 CHAIRMAN BALLINGER: This meeting will now 3
come to order. This is a meeting of the SHINE, of the 4
Advisory Committee on Reactor Safeguards, the SHINE 5
NPUF Subcommittee.
6 Im Ron Ballinger, Chairman of the SHINE 7
Subcommittee. We have a quorum, so theres no need 8
to call the attendance, I dont think. Christopher 9
Brown and Derek Widmayer are the Designated Federal 10 Officials for this meeting. I think the Court 11 Reporters on, yes.
12 The purpose of todays meeting is for the 13 subcommittee to receive a briefing from SHINE Medical 14 Technologies, LLC, which will consist of an overview 15 of SHINE medical isotope production of the facility.
16 Also, well hear from the staff on their approach to 17 review the SHINE operating license application.
18 The ACRS was established by statute and 19 discovered by the Federal Advisory Committee Act, FACA.
20 The NRC implements FACA in accordance with its 21 regulations found in Title 10 of the Code of Federal 22 Regulations, Part 7.
23 The committee can only speak through its 24 published letter reports. We hold meetings to gather 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 information and perform preparatory work that will 1
support our deliberations at a full committee meeting.
2 The rules for participation in all ACRS 3
meetings were announced in the Federal Register on June 4
13th, 2019. The ACRS section of the U.S. NRC public 5
website provides our charter, bylaws, agendas, letter 6
reports, and full transcripts of all full and 7
subcommittee meetings, including slides presented 8
there.
9 The meeting agenda for this meeting is 10 posted there. Portions of this meeting will be closed 11 to protect proprietary information pursuance to 5 12 U.S.C. 552b(c)(4).
13 For the open part of this meeting we have 14
-- well also have set aside five minutes for comments 15 from members of the public contending or listening to 16 this meeting. Weve had no request for making a 17 statement to the subcommittee.
18 A transcript of the meeting is being kept 19 and will be available on our website for the open portion 20 of the meeting.
Therefore, weve requested 21 participants in this meeting to first identify 22 themselves and speak with sufficient clarity and volume 23 so that they can be readily heard.
24 Please pause from time to time to allow 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 members to ask questions. Also, for presenters, 1
because of the video nature of this thing, this meeting, 2
please sometimes let us know what slide number youre 3
on.
4 We have a bridge-line established for the 5
public to listen in to the meeting. To minimize 6
disturbance, the public line will be kept in a listening 7
mode only. Public line will be terminated during the 8
closed session.
9 Okay, okay. Note that we have scheduled 10 the next subcommittee meeting for January 13th, 2021.
11 Per our many discussions, we are asking for SERs that 12 have been completed before the December 13th due date.
13 Also, Ill probably say this in closing 14 remarks, but in case I forget, we will have a meeting 15 to discuss the review format for SHINE in December at 16 our P&P meeting.
17 So its very important that by that time 18 we have available feedback from members related to the 19 format that we might be -- that well be agreeing to.
20 So having said that, I think we need to 21 turn to, I guess, Steve Lynch, wholl give some staff 22 opening remarks. Steve, are you there?
23 MR. LYNCH: Yes, I am here. Thank you.
24 So for everyone, my name is Steve Lynch.
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8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Im a Senior Project Manager in the Non-Power 1
Production and Utilization Facility licensing branch 2
in the office of Nuclear Reactor Regulation at the NRC.
3 I am the lead project manager for the review of the 4
SHINE operating license application.
5 I appreciate the opportunity that the 6
members are providing both SHINE and the NRC staff this 7
morning to provide an introduction to this review.
8 It is important not only to our agency, but also to 9
providing medical care to citizens of the United States 10 and around the world for the production of molybdenum-99 11 and other radioisotopes.
12 Our goal for this meeting this morning is 13 to familiarize ACRS with the NRC staffs approach to 14 reviewing the SHINE operating license application, 15 recognizing some of the unique technical and licensing 16 considerations associated, a subcritical operating 17 assembly, and production facility to be licensed under 18 10 C.F.R. Part 50.
19 So we hope that coming out of this meeting 20 we can further the conversation on the strategy for 21 engaging in additional technical subcommittee meetings 22 to --and make sure that we are able to get the ACRS 23 members the information that they need in order to 24 conduct their independent review of the application, 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 and the staffs safety evaluation.
1 So thank you for your time today and Ill 2
look forward to presenting later this morning.
3 CHAIRMAN BALLINGER: Thanks, Steve. So 4
now, I guess we turn it over to the SHINE folks. And, 5
Tracy, are you on?
6 MR. COSTEDIO: Yes. Good morning, this 7
is Jim Costedio. Im the --
8 CHAIRMAN BALLINGER: Whoops, youre not 9
Tracy. Sorry.
10 MR. COSTEDIO: No, Im not. I wanted to 11 open. Im the vice president of regulatory affairs 12 and quality for SHINE. And we want to thank the ACRS 13 subcommittee members for hosting us virtually today.
14 Were very excited to be here. Its been a long time 15 since we last met, I think October of 2015. So we have 16 made significant progress as to the construction permit 17 phase.
18 Today were going to discuss design 19 refinements that have resulted in some changes to the 20 facility. All these changes were made to improve 21 safety, constructability, and operation of the 22 facility.
23 Were also going to discuss our 24 construction status, technological approach, safety 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 philosophy, and give a process overview.
1 So we look forward to, and well embrace 2
the feedback from the ACRS subcommittee today. So we 3
have a lot to cover. Thanks again, and Ill turn it 4
over to Tracy Radel, our VP of engineering.
5 MS. RADEL: Thanks, Jim. I echo Jims 6
remarks in that we are very excited to present the 7
overview today of the SHINE design, and we look forward 8
to the questions, comments, and conversation that will 9
come out of this.
10 So lets get started. The stuff well 11 cover in the open session today includes the site plan, 12 the status of our construction process overview, 13 technological approach, and our safety philosophy.
14 SHINEs site is located in Janesville, 15 Wisconsin. You can see it here in this overhead view 16 outlined in red. As we zoom in you can see the site 17 plan shows where the production facility is relative 18 to the different support and outbuildings for the 19 facility.
20 Heres a rendering of the site. So you 21 can see what we expect it to look like, or about what 22 we expect it to look like when the construction is 23 finished.
24 Were currently undergoing construction 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 on the main production facility, the building at the 1
center there. The construction status, heres some 2
images of recent construction status. So rebar, 3
theres a significant amount of rebar in the facility.
4 You can see there this is the rebar for 5
the second lift on the east wall. You can also see 6
it in the picture here at the bottom. Heres a overhead 7
view from the crane. You can see the layout of the 8
facility, the different subgrade faults here.
9 Theres a significant number of embedded 10 items. Conduits, penetrations, pipe sleeves, some of 11 those shown here. And then in the upper right corner 12 here is a view down the irradiation unit cells prior 13 to the dividing walls being placed.
14 MEMBER BLEY: Tracy?
15 MS. RADEL: Yes?
16 MEMBER BLEY: This is Dennis Bley. One 17 question on this slide and then Id like to go back 18 two. In seeing the conduit here, I dont remember, 19 are all your cables going to be in conduit? Or some 20 in cable trays?
21 MS. RADEL: There are cable trays as well 22 as conduit.
23 MEMBER BLEY: Okay.
24 MS. RADEL: Basically.
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER BLEY: And back two slides.
1 MS. RADEL: Okay.
2 MEMBER BLEY: Im sorry, one more. I 3
didnt remember. I remembered that you were very close 4
to this small airport. I didnt remember that you were 5
kind of almost lined up with that southwest to northeast 6
runway. Thats always been your site thought, right?
7 In that same location?
8 MS. RADEL: Yes. Its the same site as 9
we had with the construction permit.
10 MEMBER BLEY: Okay. Thank you.
11 MS. RADEL: Okay. And moving on to the 12 process overview. The process begins with the 13 preparation of target solution. We take uranium oxide 14 and dissolve in sulfuric acid and peroxide, adjust for 15 pH and uranium concentration. Thats the put into the 16 process into a hold tank.
17 There are eight hold tanks. One for each 18 of the irradiation units. It is then loaded into the 19 irradiation unit using a 1/M approach. Once the 20 solution has been filled to the proper level, which 21 is nominally 5% by volume below predicted critical, 22 the irradiation unit is isolated, and irradiation 23 begins.
24 Irradiation is for approximately five and 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 a half days. And then following the five and a half 1
days of irradiation, it would be gravity drained to 2
a favorable geometry. Dump tank at the base of the 3
subcritical assembly where it would be allowed to cool 4
and a short decay period for short-lived fission 5
products.
6 Following that, it is transferred over to 7
the supercell where the molybdenum is extracted, and 8
the target solution would then flow back to the target 9
solution hold tanks.
10 The molybdenum would go through the 11 different processes within the supercell, which include 12 purification, QC checks, and then packaging before 13 being shipped out.
14 In the process of extraction and 15 purification, there are liquid wastes generated. That 16 liquid waste would be immobilized through the 17 solidification process.
18 Any questions on that?
19 MEMBER PETTI: Yes, I had a question on 20 the tritium waste. The tritium is going to permeate 21 and get into your atmosphere, and I assume youre going 22 to be cleaning up the atmosphere. And whats the 23 ultimate path for the tritium?
24 MS. RADEL: So the tritium purification 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 system, we capture that tritium and then purify it using 1
that TCAP system. Theres additional slides in the 2
closed session and that process.
3 And to be clear, the tritium system would 4
be within the tritium target chamber of the --at the 5
center of the subcritical assembly. It wouldnt be 6
in with the uranyl sulfate solution process flow here.
7 So theres quite a few more details in the closed 8
session about how the tritium purification system 9
works.
10 MEMBER PETTI: Okay, thanks. Ill wait.
11 MS. RADEL: Okay.
12 MEMBER KIRCHNER: Tracy, this Walt 13 Kirchner. And then after the target solution, thats 14 LEU, right?
15 MS. RADEL: Yes. LEU.
16 MEMBER KIRCHNER: Thank you.
17 MEMBER PETTI: And so just a question, 18 compared to the traditional way to make moly-99 with 19 ATU, is this high-specific activity or low-specific 20 activity moly-99 in terms of the separation? Or is 21 it like medium?
22 MS. RADEL: Its high specific activity.
23 MEMBER PETTI: It still is? Okay.
24 MS. RADEL: Yes.
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15 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER PETTI: Thanks.
1 MS. RADEL: And moving on to the 2
technological approach. So one key item is that these 3
are small systems; so the license limit power of each 4
of the irradiation units is 125 kilowatts. This is 5
hundreds of times less power than isotope production 6
reactors currently being used.
7 This leads to a much lower source term, 8
which helps ensure the safety of the public and 9
workforce. It also leads to lower decay heat. Were 10 at less than a kilowatt within five hours.
11 And the solution is passively cooled by 12 the light water pool following irradiation. It also 13 minimized the waste generated in the isotope production 14 because the majority of fissions that are occurring 15 within the system are occurring to produce recoverable 16 moly.
17 So in the current system, the reactors have 18 a significant amount of fission occurring within the 19 fuel that is not directly going to generating moly for 20 isotope production.
21 We use a low-enriched uranium reusable 22 target. The ability to reuse the target efficiently 23 greatly reduces waste.
24 The use of a uranium target means that its 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 compatible with the current supply chain producing that 1
high-specific activity moly that the industry is used 2
to. And the use of low-enriched uranium eliminates 3
the need for highly enriched uranium.
4 Its driven by a low-energy electrostatic 5
accelerator. This means that when the accelerator is 6
turned off that the fission essentially terminates 7
shortly after. And this a key design feature of the 8
system.
9 The multiple units, multiple irradiation 10
- units, and multiple processing trains provide 11 operational flexibility and scalability. So we have 12 eight individual irradiation units, and then we have 13 three independent processing lines.
14 And each of the eight irradiation units 15 can be processed through multiple processing lines.
16 MEMBER BLEY: Tracy, maybe youre going 17 to talk about this in the closed session, Im not sure, 18 but last time around the way designed this you were 19 running very close to critical. Have you changed your 20 plans for operating regime? Or is going to be about 21 the same as we saw before?
22 MS. RADEL: Its about the same as before.
23 So the 5% by volume below critical, and there is more 24 on that in closed session.
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER BLEY: Thank you.
1 MS. RADEL: Yes. Part of the safety 2
philosophy, the systems are at low pressure slightly 3
so the atmospheric low temperature and have a low decay 4
heat. And this means that theres minimal stored 5
energy there to drive any type of release if it were 6
to occur.
7 The independence of the eight irradiation 8
units limits common cause failures, it limits the source 9
terminates available. The units do not require any 10 operator actions to mitigate the consequences of an 11 accident.
12 And in the event of an on-site condition, 13 the TSV reactivity protection system would initiate 14 a trip. That trip would open two completely 15 independent safety related TSV dump valves, and the 16 target solution would gravity drain to the TSV dump 17 tank, which is safe for all uranium concentrations.
18 The hydrogen concentration is maintained 19 below the lower flammability limit by the off-gas 20 system. Following the battery run time, the entire 21 plant is passively safe. So the target solution was 22 cooled by the pool its sitting in. And the pool 23 temperature would not rise more than 13 degrees over 24 90 days without any active cooling.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The nitrogen purge system provides 1
hydrogen control. It provides a sweep gas through the 2
system to purge the hydrogen.
3 MEMBER PETTI: Just a question on the 4
accelerators and the assumptions of your design.
5 Theres a certain level of fusion that occurs, is there 6
a margin in terms of what if you get better fusion than 7
you think and so you end up with more neutrons and, 8
you know, going into the uranium. Is there a margin 9
there?
10 MS. RADEL: Yes, so the power is monitored 11 through the detectors, and they would catch any kind 12 of increase in production of the drivers, which would 13 drive, you know, power up within the subcritical 14 assembly.
15 Theres not a mechanism that would lead 16 to drastically increased production by the neutron 17 drivers beyond what theyve been testing or show to 18 be capable of. And we can talk more in details of that 19 in the closed session.
20 MEMBER PETTI: Okay.
21 MR. RADEL: Okay. Any other questions?
22 This is the last slide for open session.
23 CHAIRMAN BALLINGER: No questions? We 24 have made a potentially fatal error in that were ahead 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of schedule. I think at this point we need to make 1
sure the public line. Im assuming it is. So I think 2
it is, yes, yes.
3 So are there any members of the public that 4
would like to make a comment?
5 MALE PARTICIPANT: The line is open for 6
comment.
7 CHAIRMAN BALLINGER: Thank you. If so, 8
please state your name and make your comment.
9 Im hearing none. I think we can close 10 the public line.
11 We need to now transfer to the closed 12 session. Let me go offline -- transfer to the closed 13 session. So we need to leave this session and then 14 rejoin in the closed session. So we should take about 15 a ten-minute break. Its 9:52 so at just a little bit 16 after 10, say 10:05, to round things up.
17 Well rejoin in the closed session. So unless 18 there are other member comments, well now leave this 19 session, and well see you in the closed session.
20 (Whereupon, the above-entitled matter went 21 off the record at 9:52 a.m. and resumed at 11:55 a.m.)
22 CHAIRMAN BALLINGER: Okay. Its 11:55.
23 Were back in session and I think Steve Lynch, youre 24 up.
25
20 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MR. LYNCH: Yes. Thank you very much.
1 Thankfully my Teams just cooperated, and I am back 2
online. Just confirm for me when you can see my 3
presentation slides that Im sharing.
4 CHAIRMAN BALLINGER: I could see your 5
slides but its not full screen.
6 MR. LYNCH: Okay. Lets do that right 7
now. Okay. Now I can take of this.
8 CHAIRMAN BALLINGER: Looking good.
9 MR. LYNCH: Okay. Thank you everyone for 10 your time this morning and afternoon. I will try to 11 make sure I pay attention to the time, but if we need 12 to speed up feel free to let me know and we can adjust 13 the pace.
14 To compliment SHINEs presentation 15 regarding the overview of their technology, what Id 16 like to present today as a first step is our engagement 17 with the ACRS members on the SHINE Medical Technologies 18 operating license application review is to provide some 19 background and also the test and methodology with the 20 NRC staff needed to review the SHINE operating license 21 application.
22 And hopefully what we can do coming out 23 of this meeting is continue our conversation on how 24 to best approach the technical subcommittee meetings 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that are to follow this licensing meeting that we have 1
having so that we can one, make sure that were providing 2
the information that is most useful to the ACRS members, 3
and also make sure that we are streamlining our process 4
to the extent that we are presenting information in 5
a way that is focusing on whats most safety significant 6
for this application, and providing appropriate context 7
for the discussions that we have.
8 So the first couple slides Im going to 9
go through some background on our NRC staff involvement 10 in these reviews, some of the drivers that come from 11 applicable statutes, coordination with other federal 12 agencies, and also drivers that we have from external 13 to external to the government.
14 So when it comes to medical radioisotopes, 15 and in particular, the production of molybdenum-99 that 16 SHINE is proposing to produce, there is a significant 17 effort from the international community, and in line 18 with U.S. policy, to establish a domestically available 19 and reliable supply of this medical radioisotope 20 without using highly enriched uranium.
21 SHINE discussed earlier this morning they 22 are using an LEU solution in order to produce 23 molybdenum-99. As you may know, 6% of the fission 24 products of U-235 are molybdenum-99. And when you have 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 those pure molybdenum-99 fission products, you do end 1
up with high-specific activity technetium-99 2
metastable because you dont have other molybdenum 3
isotopes that could reduce the specific activity that 4
then is provided as the radiopharmaceutical for 5
diagnostic or therapeutic purposes.
6 As far as the NRC is concerned, we do look 7
at initial license applications and license amendment 8
requests for a variety of different types of licensing 9
actions that involving manufacturing of targets for 10 irradiation, the actual technologies that are used for 11 irradiation, and the processing of those targets once 12 theyve been irradiated.
13 For the purposes of the office of Nuclear 14 Reactor Regularization, our focus is primarily on those 15 utilization and production facilities that are covered 16 under 10 C.F.R. Part 50, which is our framework that 17 we use primarily for reviewing nuclear power reactor 18 and non-power reactor facilities.
19 In terms of what our drivers are outside 20 of our regulations and the applications that come to 21 us, we do have coordination with other federal agencies 22 for reviews related to molybdenum-99. In particular, 23 there is the American Medical Isotopes Production Act 24 that does provide the coordination between the NRCs 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 staff and the National Nuclear Security Administration.
1 There are two key provisions of this act 2
that are applicable to the NRC. One of those is on 3
coordination of the National Environmental Policy Act 4
of use, or environmental disuse.
5 Basically, the provision there is for those 6
actions where both the NSSA and the NRC have federal 7
jurisdiction should we need to coordinate on those NEPA 8
reviews. So we are preparing a joint supplemental 9
environmental impact statement to support the review 10 of the operating license application with NSSA.
11 And then the other piece of this is a 12 uranium lease and take-back program. The act provided 13 that DOE NSSA establish this uranium lease and take-back 14 program in particular so that if there is waste that 15 does not have a commercial disposition pathway that 16 the Department of Energy, through an agreement with 17 an applicant, would be responsible for disposing of 18 that waste.
19 And that program is established and 20 available to all applicants through SHINE. Also, there 21 is coordination with the Department of Homeland 22 Security, and this has to do with site vulnerability 23 assessments that are performed for any new utilization 24 facility constructed in the United States.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 This vulnerability assessment was 1
performed at the construction permit stage of the SHINE 2
review, and the results of that were taken into 3
consideration by both the NRC staff and the applicant 4
in the review of the application and preparation of 5
the application.
6 And then the other act that I would like 7
to highlight here that is applicable to the work that 8
we are doing is the Nuclear Energy Innovation and 9
Modernization Act.
10 Among the many provisions of this act, one 11 of the items that is applicable to our review of the 12 SHINE operating license application is the 13 establishment of review periods, in particular, from 14 an initial licensing application setting a generic 15 review schedule of three years is provided for the NRC 16 staff to establish.
17 As I go on, I do want to just from an 18 administrative point of view, I am hearing some pop-ups 19 and potential comments coming up. Unsure if theyre 20 being directed to me or not. I just want to say that 21 while Ive got my presentation in full screen mode, 22 I cant see any text messages that may be sent via Teams.
23 So if someone, particularly the ACRS members, if you 24 have something youd like for me to address, please 25
25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 speak up.
1 CHAIRMAN BALLINGER: This is Ron. I dont 2
think we use that method.
3 MR. LYNCH: Okay.
4 CHAIRMAN BALLINGER: So youll hear 5
voices.
6 MR. LYNCH: Okay. No problem. I just 7
wanted to make sure that Im not missing anything 8
because I cant see it.
9 Okay. Now, to get back into a little bit 10 more of the policy work that the NRC staff has engaged 11 in to prepare for the review of non-power production 12 or utilization facility reviews and the SHINE review, 13 theres a couple rulemakings that I do want to highlight 14 that are of particular relevance and importance to the 15 work that were doing.
16 One of these is the non-power production 17 or utilization facility, or NPUF, license renewal final 18 rule that was submitted to the commission for 19 consideration in June of 2019.
20 While the focus of this rule was looking 21 at eliminating license renewal terms for certain NPUF 22 facilities, one of the other provisions of this rule 23 that will have a direct impact on our licensing of 24 facilities like SHINE is the establishment of an 25
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 accident dose criterion, which does not currently exist 1
in our regulations for a facility like SHINE.
2 So what that would do is establish an 3
accident dose criterion of one rem at the site boundary 4
for facilities like SHINE.
5 Currently, in absence of having a
6 regulatory requirement for accident dose criterion for 7
non-power production and utilization facilities, the 8
NRC staff has conservatively accepted proposals from 9
currently licensed non-power reactors 5 and medical 10 radioisotope facilities, like SHINE, to previously use 11 100 millirem as their accident dose criteria, which 12 is consistent with the normal annual release limits 13 in 10 C.F.R. Part 20.
14 So expanding to the one rem dose limit is 15 consist with the EPA PAGs. And I believe through the 16 regulatory audit we had with SHINE on their accident 17 analysis, SHINE is planning on adopting that accident 18 dose criterion of one rem for their facility.
19 And then the other rulemaking that is 20 important to the work that were doing with SHINE that 21 kind of guides the regulatory review that we are doing 22 was the definition of utilization facility direct final 23 rule that was published in the Federal Register in 24 October of 2014.
25
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The significance of this rulemaking was 1
expanding the definition of utilization facility in 2
10 C.F.R 50.2 to include, by docket, a SHINE accelerator 3
driven subcritical operating assemblies.
4 So this was a rule of particular 5
applicability, meaning that it was limited to a single 6
entity. So in order to ensure that we did not have 7
unintended consequences by impacting other subcritical 8
facilities, this rulemaking was limited to just the 9
SHINE technology.
10 And the practical implication of this 11 rulemaking is providing that the SHINE subcritical 12 operating assemblies would be licensed as utilization 13 facilities. So they would follow a similar licensing 14 path to non-power reactors that are licensed by the 15 NRC.
16 Now I touched on this briefly in one of 17 my earlier slides, but I did want to highlight the scope 18 of technologies that are covered under radioisotope 19 production processes that the NRC looks at. And this 20 really breaks down into four main categories.
21 Weve got target manufacturing, target 22 irradiation, target processing, and then the medical 23 use of byproduct material. For the SHINE application, 24 what we are focused on is the target irradiation using 25
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 subcritical operating assemblies, and then the target 1
processing that utilizes SHINEs hot cell facility to 2
process the irradiated low-enriched uranium solution 3
to extract the molybdenum-99.
4 The target manufacturing we have seen for 5
other applications for the manufacturing of solid LEU 6
targets that would be placed in reactors for other 7
facilities or irradiation. And then the medical use 8
of byproduct material really gets down to the generators 9
that actually are doing the extraction of the 10 technetium-99m from the molybdenum-99, which is not 11 part of the SHINE proposal.
12 And when were -- you know, one of the 13 things that drove our rulemaking to classify SHINEs 14 subcritical operating assemblies as utilization 15 facilities really came down to what were the safety 16 considerations for that facility.
17 When we were looking at this there was the 18 initial where the question came up because in order 19 to be a utilization facility under the NRCs traditional 20 regulatory framework, a facility would need to be a 21 nuclear reactor, meaning that it is capable of a 22 self-sustaining chain reaction or having that 23 criticality.
24 Being a subcritical facility, SHINE did 25
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 not meet that definition of a nuclear reactor.
1 However, due to the limited margin or subcriticality 2
that SHINE has, there were many safety considerations 3
that made more sense to look at the SHINE subcritical 4
operating assembly more similarly to how we would 5
evaluate an aqueous simultaneous reactor, including 6
removal of fission heat, aheat generation, generation 7
of fission gasses, and also looking at the potential 8
accident scenarios.
9 That being said, with the SHINE hot cell 10 facility there are other technical considerations that 11 fall outside of the normal scope of what we would look 12 at for a reactor technology.
13 And for SHINE in particular, this has to 14 do with some of the criticality considerations for the 15 hot cell facility. Making sure that there is an 16 approved margin of subcriticality in the hot cell 17 facility, and also making sure that SHINEs criticality 18 safety program is applied consistently throughout the 19 facility in all of those areas except for the target 20 solution vessel where the goal is to have that minimum 21 margin of subcriticality.
22 And then, also the importance is looking 23 at some of the chemical hazards associated with license 24 material that are present in the facility due to the 25
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 processing of the irradiated targets that weve shown.
1 So to kind of bring all of this together, 2
our organization, the Division of Advanced Reactors 3
of Non-Power Production of Utilization Facilities, does 4
have the primary responsibility for leading the project 5
management and reviews of non-power production of 6
utilization facilities, including the medical 7
radioisotope facilities. And this includes looking 8
at non-power reactor technologies, subcritical 9
operating assemblies, and production facilities.
10 The SHINE facility is going to be licensed 11 as a commercial facility under Section 103 of the Atomic 12 Energy Act. And this does contribute some slight 13 differences in how we look at their facility versus 14 how we would review a research or test reactor.
15 And mainly this comes down to the 16 implementation of the minimum regulation provision of 17 the Atomic Energy Act that is afforded to research and 18 test reactors licensed under Section 104c.
19 So as a commercial facility, SHINE does 20 not have that minimum regulation provision applicable 21 to them. That being said, we are tailoring our review 22 based on the safety significance of the facility to 23 ensure that our resources and reviews are focused on 24 those safety related structures,
- systems, and 25
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 components that are necessary to protect the public 1
health and safety.
2 So given the different types of 3
technologies that were looking at with SHINE, we are 4
relying on the technical expertise from organizations 5
throughout the NRC outside of NRR.
6 And, in particular, we are looking to the 7
office of Nuclear Security and Incident Response to 8
help with our reviews of emergency planning and physical 9
security.
10 We also are looking to our office of Nuclear 11 and Material Safety and Safeguards to help with looking 12 at the material component accounting program, support 13 and accident analysis review, chemical safety, and 14 criticality safety, which are expertise areas that we 15 do not have in NRR to complete this review.
16 Now a little bit of background on the SHINE 17 application itself. Previously we did receive a 18 two-part instruction permit application in 2013 for 19 the SHINE facility that consisted primarily of an 20 environmental report and preliminary report.
21 As you heard from SHINE, the basic process 22 involves irradiating and low-enriched uranium target 23 solution in its irradiation facility consisting of 24 eight irradiation units, and then processing that 25
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 irradiated target solution in the radioisotope 1
production facility consisting of the hot cells.
2 Following our review of this application, 3
a construction permit was issued in February of 2016 4
and SHINE commenced construction of its facility in 5
September of 2019 in Janesville, Wisconsin.
6 I do want to just clarify on this date for 7
commencing construction. This is what the NRC staff 8
considers construction under our definitions in 10 9
C.F.R 50.10. My understanding is that SHINE did have 10 other site preparation work that had to be done prior 11 to that September 3rd date.
12 Now this touches a little bit on the items 13 that were highlighted in the ACRS member letter I follow 14 that supported issuance of the construction permit and 15 looking at what was covered in that appendix A of the 16 staff safety evaluation report, which covered items 17 that would need follow-up past the issuance of the 18 construction permit.
19 There were several items contained in that 20 appendix. Among those include these periodic reports 21 on permit conditions were addressed. We also had 22 technical areas where SHINE had made regulatory 23 commitments to provide information in the operating 24 license application for the NRC staff review to make 25
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 an ultimate safety finding.
1 So before I get into the particulars of 2
these permit conditions, what Ill highlight when it 3
comes to how the staff is conducting its review of this 4
Part 50 application, at the construction permit stage, 5
the NRC staff did not make any ultimate safety findings 6
that were final.
7 And because of the nature of the SHINE 8
design that was going to continue to evolve as it went 9
from a preliminary design to a final design. And I 10 believe thats highlighted with the design changes that 11 SHINE presented at the beginning of todays meeting.
12 So what this means is while the NRC staff 13 conducted a review of all of the available information 14 at the construction permit stage as described in that 15 appendix A, and in the regulations in 10 C.F.R. 50.35, 16 there is an expectation that information that had not 17 previously been reviewed or considered would be made 18 available to the NRC staff in order to make its safety 19 findings and ultimately issue an operating license 20 application.
21 So because the --
22 RECORDING: Mute on.
23 MR. LYNCH: Im sorry, one sec. Okay.
24 That was not my mute, so I am still here. My apologies.
25
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Let me get back to full screen. I just wanted to make 1
sure that I was not inadvertently muted.
2 So my apologies. So essentially what I 3
would like to highlight here is going from the 4
construction permit review to the operating license 5
application review, the NRC staff is not so much 6
conducting a delta review looking at those differences, 7
so much as we are potentially taking a fresh review 8
of the application.
9 So in all areas that we looked at during 10 the construction permit application review, we are 11 looking at again, based on the updated and complete 12 design information provided in the SHINE final safety 13 analysis report.
14 That being said, the NRC staff is informing 15 its review of this final information by looking back 16 to the items highlighted in appendix A for those areas 17 where SHINE had made commitments to providing updated 18
-- and to the extent that design changes have made 19 certain commitments no longer applicable and necessary, 20 the NRC staff will make note of that as part of our 21 ultimate evaluation findings.
22 And, you know, our intent is also as we 23 prepare our safety evaluation report, input to address 24 these areas in appendix A to make sure that, yes, the 25
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 NRC staff did make a standalone review of the FSAR 1
information to the extent that they were relevant and 2
valid.
3 And the commitments made by SHINE at the 4
construction permit stage that are also applicable and 5
necessary for us to make our necessary evaluation 6
findings based on our standard review plan and the 7
regulatory findings in 10 C.F.R., we will make sure 8
that all of that is addressed and presented to the ACRS 9
members as we go through our technical presentations.
10 With respect to these particular periodic 11 reports, recognizing that SHINE had a fair amount of 12 development work to go when the construction permit 13 was issued in the areas of its criticality accident 14 alarm system, nuclear criticality safety evaluations, 15 and additional shielding design application, the NRC 16 staff did have these conditions on the permit for SHINE 17 to provide reports to us that would provide updates 18 on how they were developing the information.
19 The primary goal in having this information 20 was to support construction inspection activities 21 should they have to be done prior to the submission 22 of the operating license application, and that would 23 contain the complete technical -- to make sure that 24 our inspectors would have all of the information they 25
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 needed in order to conduct their inspections.
1 Now based on how the timing of all of this 2
worked out, while weve had these periodic reports 3
submitted by SHINE, SHINE submitted its operating 4
license application in July of 2019, and our first 5
construction inspection activities began in December 6
of 2019 following SHINEs commencement of construction 7
in September of 2019.
8 So the inspection information that we are 9
using is based on the FSAR and supporting materials 10 that SHINE provides to NRC staff in its electronic 11 reading as necessary to support specific inspection 12 activities.
13 So while SHINE provided this information, 14 the current information that we are using support our 15 review and inspection activities is based on the end 16 test for that.
17 So with this, I think I can go through the 18 next few slides fairly quickly as weve covered most 19 of this already. The main point here that I want to 20 emphasize is that the SHINE irradiation facility, which 21 consists of the eight subcritical irradiation units 22 is going to be licensed and reviewed against the 23 requirements in 10 C.F.R. Part 50, which mostly mirror 24 those requirements used to evaluate applications for 25
37 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 non-power reactors.
1 And then for the radioisotope production 2
facility, this is also evaluated under the NRC staff 3
regulations and guidance under Part 50 for a production 4
facility.
5 As you may be familiar, there are three 6
different types of production facilities described in 7
the NRCs regulations. This includes those production 8
reactors used for the production of special nuclear 9
material, like the Hanford reactor, new processing 10 facility, like the West Valley facility, and then the 11 third type of production facility is for those 12 facilities used for the separation of byproduct 13 material from irradiated special nuclear material.
14 And thats what all of the medical 15 radioisotope facilities have proposed that are using 16 low-enriched uranium and having separation processes.
17 Now the important distinction here, and 18 when were determining what the appropriate licensing 19 process is to apply to these facilities, we are looking 20 at what is the bath size, so how much special nuclear 21 material is going to be processed at one time.
22 I our regulations there is a threshold 23 drawn at 100 rams. So if a facility is processing 24 greater than 100 rams of special nuclear material at 25
38 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 one time, that is what pushes them into the Part 50 1
requirement for a production facility.
2 If a facility were to stay below that 100 3
ram threshold, they would be licensed under 10 C.F.R. 4 Part 70 for similar to existing fuel cycle facilities.
5 That being said, while the SHINE production 6
facility is being licensed under 10 C.F.R Part 50, as 7
I mentioned earlier, we are relying on technical staff 8
from our office of NMSS to support us in our review 9
of certain accident sequences, criticality safety, and 10 chemical safety to the extent that there are technical 11 similarities between the production facility and fuel 12 cycle facilities.
13 So in addition to the Part 50 license that 14 SHINE has requested, there would be provisions under 15 this license ensuring that SHINE is meeting applicable 16 proximity requirements for the possession and use of 17 special nuclear material, and for the possession and 18 use of source material under Part 70 and Part 40, 19 respectively.
20 Now Ill transition to a little bit more 21 talking about the specifics of the NRC staff review 22 of the operating license application that was submitted 23 by SHINE back in July of 2019.
24 So following that submission of the 25
39 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 application back in July, the NRC staff performed a 1
60-day acceptance review of the application and 2
accepted the application for review in October of 2019.
3 Based on this accepted review, the NRC 4
staff did highlight certain technical areas that were 5
going to require focused attention and engagement 6
between the NRC staff and SHINE in order to make sure 7
that weve reached a technical and licensing 8
resolution.
9 The two main topics identified were 10 instrumentation and control systems, and the accident 11 analysis and methodology. The reasoning for 12 highlighting these areas, we recognize that for SHINEs 13 instrumentation and control systems they are utilizing 14 the Rock Creek platform that NuScale has used for its 15 I&C systems.
16 And in particular, our staff wants to make 17 sure that from the safety evaluation prepared for the 18 NuScale system that appropriate consideration has been 19 given to the 65 application specific items in our review 20 of the application, and making sure that we are 21 consistent in our review methodologies of the SHINE 22 I&C systems and of recent digital upgrades weve had 23 for research reactors.
24 MEMBER BROWN: Can I ask a question, Steve?
25
40 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MR. LYNCH: Sure. Absolutely.
1 MEMBER BROWN: When you talk about 2
utilizing the NuScale systems, does that mean -- and 3
you talked about the Rock Creek, the most reasonable 4
would be -- I may be on the wrong branch with this, 5
but their reactor protection system and their ESFAS 6
system, whichever one, however we want to call it here, 7
utilize field programmable gate arrays as opposed to 8
microprocessors in the their processing. Is that what 9
youre talking about? Because weve seen nothing 10 relative to what they look like now.
11 MR. LYNCH: Sure. So at a high level, what 12 I will say SHINE does have an ESFAS system in the --
13 RECORDING: Mute on.
14 MR. LYNCH: In the Rock Creek platform that 15 has been customized for SHINE. With respect to the 16 use of the microbe processors, I think I would refer 17 to SHINE to answer what they are specifically using 18 in that.
19 But it is a -- but what I will say is that 20 it isnt an exact replica of the NuScale platform.
21 It has been customized for SHINE.
22 MEMBER BROWN: Well, customization is 23 fine. I understand theres a big difference between 24 an operating plant and this facility set up. And if 25
41 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that difference was, you know, evident in our earlier 1
review, I was just wondering if when you say it was 2
consistent, the FPGA approach that they used is not 3
a software-based driven system.
4 It was almost like hard-wired stuff once 5
you program the FPGAs. So thats all I was interested 6
in when you were talking about the details. Because 7
we didnt get that detail before.
8 MS. RADEL: Yes. So this is Tracy Radel 9
with SHINE again. We are using the HIPS platform highly 10 integrated protection --
11 MEMBER BROWN: Okay.
12 MS. RADEL: --system from Rock Creek and 13 it is using those field programable gate arrays, the 14 FPGAs.
15 MEMBER BROWN: Okay. Excellent. Thats 16 just what -- I wanted to make sure I -- I didnt refer 17 to it as Rock Creek. I always thought of it as HIPS.
18 So you said the magic words.
19 MS. RADEL: Yes.
20 MEMBER BROWN: Okay. Thank you very much.
21 MR. LYNCH: Thank you. And then the other 22 focus area for the NRC staff has been the accident 23 analysis performed by SHINE.
24 Weve had some successful audits.
25
42 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Actually, both of these technical areas that has 1
furthered our review, in particular, with the accident 2
analysis methodologies.
3 One of the outcomes of our recent audit 4
with SHINE that I began in August of this year and 5
concluded a few weeks ago in October was reevaluating 6
how SHINE was performing its accident analysis to make 7
sure that a complete set of design basis accidents were 8
presented in the application, and also to ensure that 9
we had a mutual understanding of how SHINE was using 10 its SHINE safety analysis that is an undocketed report 11 that SHINE discussed that covered additional accident 12 sequences and controls that had been identified for 13 different accident categories, and making sure that 14 we had connection between the SSA, SHINEs design basis 15 accidents, and then ultimately what is being treated 16 as a founding accident scenarios against a one rem 17 criteria.
18 So this here, we do have a set up request 19 for additional information on the accident analysis 20 that are prepared. Theyre in concurrence right now 21 and ready to be issued this week. And we are expecting 22 to have responses for requests for additional 23 information, and an updated safety, final safety 24 analysis report on this information submitted in about 25
43 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 30 days.
1 So by early December we expect to have 2
updated information on the accident analysis and 3
methodologies, and have essentially this portion of 4
the review resolved. So thats --
5 MEMBER BLEY: Steve?
6 MR. LYNCH: Yes?
7 MEMBER BLEY: Its Dennis Bley. I have 8
two questions.
9 MR. LYNCH: Yes.
10 MEMBER BLEY: One you jumped at me as you 11 said this, the other one I thought earlier. When you 12 guys have been doing your review, have you had access 13 to or in the FSAR anywhere, I havent had a chance to 14 look through new documents, the process flow sheets 15 for the chemical side of the plant.
16 The other question is I think I just heard 17 you say the safety analysis document thats undocketed 18 is -- tell us more about that.
19 MR. LYNCH: Sure. So in order to support 20 our reviews of the application, SHINE has established 21 an electronic review portal to upload reference 22 materials to include different flow sheets and tables 23 and calculations and procedures and analyses that 24 support the docketed material in the FSAR.
25
44 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And they have provided those in areas of 1
their accident analysis to include criticality safety 2
and chemical safety. And when it comes to this SSA, 3
so this is not information that the NRC staff would 4
typically expect to be docketed.
5 To provide a little bit of background, this 6
SSA previously was referred to as SHINEs integrated 7
safety analysis, or an ISA, that -- and what this 8
represents is a methodology that SHINE used to ensure 9
that they were identifying all of the potential accident 10 sequences and initiating events at the facility, be 11 able to root them, identify the most limiting event 12 within those that becomes a design-basis accident, and 13 also identify the necessary controls for that 14 particular accident sequence.
15 Now, for the --
16 MEMBER BLEY: So youre -- or --
17 MR. LYNCH: Sorry --
18 MEMBER BLEY: Or maybe the SHINE folk, from 19 our previous discussion, my understanding was that that 20 information Steve just described would also be 21 accessible to the members of the ACRS. Is that correct?
22 MR. LYNCH: So following the October 22nd 23 meeting, I have had some discussions with SHINE about 24 setting up a custom portal for the ACRS members to review 25
45 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 information. And one of the documents that we 1
highlighted that would most likely be of high interest 2
and value to the members in their review was this 3
document.
4 So following this meeting, what would I 5
like to do is start working with SHINE on getting this 6
portal up and running and start populating some of these 7
documents that are most relevant and of interest to 8
the members to help to support your review of the 9
application.
10 MEMBER BLEY: Okay. Thanks. Thats 11 really important. Now, you didnt get to the process 12 flow sheets. Sorry I cut you off. Go ahead.
13 MR. LYNCH: Oh, well, I guess what I was 14 saying is with the -- so when it comes to our review 15 of the information thats in the SSA, some of the 16 requests for additional information, whats important 17 to us in terms of docketed materials is making sure 18 that SHINE has a sufficient description of the 19 methodology.
20 So what we want is, while we dont need 21 them to docket the SSA in its entirety, we want to make 22 sure that in the FSAR they describe what their process 23 was and what makes it acceptable so that based on our 24 review of that material we still have something in the 25
46 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 FSAR to say yes, this methodology is acceptable and 1
can be used going forward.
2 Should there be design changes at the 3
facility, the expectation is that SHINE will still 4
perform a 50/59 analysis to determine if a license 5
amendment is necessary to submit to the NRC staff.
6 And as part of either looking at a license 7
amendment or design changes that -- so let me step back.
8 If its a license amendment the NRC staff could request 9
to look at the SSA as its been updated to reflect that 10 amendment to ensure that its being maintained.
11 And then should there be design changes 12 that screen out and do not require an amendment, hearing 13 inspection activities, NRC inspectors could look at 14 that SSA to ensure that its being kept up to date with 15 changes of the facility.
16 For particular flow sheets I would need 17 to confirm with you that we had our reviewer look at 18 that information related to chemical safety. We did 19 request that SHINE did provide some documents in its 20 electronic reading room on chemical safety and I can 21 confirm with our reviewer what he had looked at.
22 But we do have a chemical safety RAI that 23 was developed to complete our review and make sure we 24 have what we need on that.
25
47 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER BLEY: Okay. I was hoping that 1
would end up being up on that portal when we looked.
2 My past experience with chemical processing plant 3
safety is if you dont -- if the key information you 4
need to be able to really look at safety is in those 5
sheets.
6 MR. LYNCH: What Ive done, though, is Ive 7
made a note and we can work with SHINE on getting that 8
information for you.
9 MEMBER REMPE: Can you give us an idea of 10 the schedule of when youll have this portal up and 11 running? Or at least a list of documents that would 12 be included in it?
13 MR. LYNCH: Sure. So some of us all need 14 to coordinate with SHINE on what itll take to get this 15 updated. So I could talk to SHINE about their schedule 16 for that and I think as were talking today Im making 17 notes on what some of these documents are that are key.
18 Because one of the things that we want to 19 make sure is that, and I can let SHINE speak to this 20 as well since these are their documents, is that, you 21 know, the desire is to make sure that we are providing 22 the most high value documents to the members that is 23 organized and easy to access.
24 So I think we can have the portal up in 25
48 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the short term and start, you know, start putting 1
together that list of documents. You know, I think 2
stemming out of that SSA is going to be important as 3
a starting point.
4 And we can work with you on the types of 5
documents that youre interested in, and maybe SHINE 6
might have a comment on this as well. But I think, 7
you know, the desire is to make sure that were being 8
responsive the most safety significant concerns that 9
the ACRS members have, and not necessarily just 10 overwhelming you with all of the hundreds of thousands 11 of documents that SHINE has that are non-docketed.
12 MEMBER REMPE: So I hear that youre going 13 to try and get it to us soon. I understand that it 14 may not be complete, but I know in later slides you 15 grouped chapters and Im not sure which grouping will 16 come to us first.
17 But maybe a preliminary list of some of 18 the supporting documents that you find most important 19 could be provided in a list by, within the next couple 20 of weeks or when?
21 MR. LYNCH: Sure. We can -- so following 22 this meeting, Ill have a conversation with SHINE and 23 lets see, within the next couple weeks maybe we can 24 make a goal of, where are we at, prior to maybe that 25
49 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 week of November 16th.
1 So prior to Thanksgiving we could work on 2
having that portal up and some initial documentation.
3 And what can be helpful too is maybe after we get those 4
initial documents, receive some feedback from the ACRS 5
members on the types of documents.
6 I can work with SHINE on highlighting for 7
each of the technical areas, maybe if there are certain 8
supporting documents that may be of interest. Maybe 9
there are certain documents related to seismic analysis 10 or aircraft impact that would be interest.
11 But we can, Ill work with SHINE on 12 identifying that.
13 MEMBER REMPE: A couple of weeks with the 14 list and some preliminary set of documents would be 15 awesome. Thank you.
16 CHAIRMAN BALLINGER: You know we need to, 17 Im sure we, you know, we need to work through Chris 18 on this.
19 MR. BARTELME: And Steve, thats certainly 20 something SHINE can support. We can get that ACRS 21 specific reading groups quite quickly, and well get 22 a line of document types. So we can pool them and make 23 them available quickly.
24 MR. LYNCH: All right. So I am realizing 25
50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that were starting to -- it is 12:40 so Ill speak 1
a little bit more quickly through these next slides 2
so that we are affording some time for closing comments 3
from the members.
4 So where were at here is we have 5
established a 24-month review schedule to prepare the 6
safety evaluation for the SHINE application. And that 7
was established in April of this year.
8 So our goal is to complete our technical 9
review and have a complete safety evaluation prepared 10 by October of next year.
11 I talked through most of this so Ill go 12 through these slides relatively quickly. The main 13 difference is I wanted to highlight here between 14 construction permit and operating license application 15 reviews is, while the processes are similar, we are 16 looking at a FSAR and all of the information as presented 17 in there.
18 As more or less a fresh review of 19 information the difference then is with the 20 supplemental environmental impact statement, that is 21 more of a delta review that only new or significantly 22 different information is evaluated.
23 Per our processes, we are still going 24 through the ACRS subcommittee and full committee. And 25
51 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 then one of the differences we have here for our hearings 1
is there is no mandatory hearing for the issuance of 2
the operating license. There was only a mandatory 3
hearing of the construction permit stage.
4 There was a notice, an opportunity for 5
petition to leave and intervene in the SHINE 6
proceedings. There were no requests for a contested 7
hearing for this application.
8 Now as for the review methodology, similar 9
to the construction permit and for the operating license 10 application review, we are using NUREG-1537 as 11 augmented by interim staff guidance for aqueous 12 homogenous reactors and production facilities.
13 We are also using other guidance including 14 regulatory guides and industry standards to conduct 15 our review. Now, whats important about this, and Im 16 sure as the members look at the SHINE final safety 17 analysis report and the NRC staffs SVR, our approach 18 to looking at SHINEs application of codes and standards 19 is really tailored to the commitments that they make 20 in the FSAR.
21 Recognizing that for the most part 22 particular codes and standards were developed for 23 specific technologies that SHINE is not, including 24 certain full cycle codes for criticality analysis, 25
52 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 codes for nuclear power reactors, codes for even 1
research reactors.
2 So recognizing that not all of these codes 3
and standards may be applicable in their entirety to 4
SHINE as we are conducting our review of the 5
application. We are paying particular attention to 6
the commitments SHINE makes to either using codes in 7
full or in part, and making sure that there is sufficient 8
justification for how they are using these codes.
9 So that is probably one of the significant 10 pieces of this review in ensuring that SHINEs adherence 11 to their commitments to codes and standards is also 12 supporting their principal design criterion identified 13 in the application.
14 For the review as we discussed, I think 15 at the internal ACRS on October 22nd, the NRC staff 16 had broken up the review into some different review 17 areas.
18 There were certain portions of the review 19 that we were able to move straight to preparation of 20 request for additional information. And then then 21 there were other areas, such as the I&C systems, the 22 accident analysis, criticality safety, that required 23 more in-depth coordination with SHINE.
24 And what one of the ways that we pride 25
53 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 leveraging communication between the NRC and SHINE was, 1
and continues to be, the use of regulatory audits to 2
further our understanding of technical gaps that have 3
been identified by the NRC staff and resolve those to 4
the extent practical of the regulatory audits so that 5
we can then issue focused requests for additional 6
information and reduce the need for follow-up RAIs.
7 When it comes the issuance of the 8
construction permit, again, the findings that we 9
basically made were making sure that we had enough 10 preliminary information to feel confident that SHINE 11 could go and construct their facility.
12 It did not authorize to have any material 13 on site. And essentially safety questions resulting 14 from the final design would be resolved with the 15 submission of the FSAR.
16 Now when it comes to issuing the operating 17 license, the things that were going to be looking at 18 is making sure that weve met all of our safety 19 evaluation findings described in NUREG-1537, making 20 sure that again, some of these commitments that SHINE 21 had made as documented in appendix A to the construction 22 permit safety evaluation report have been addressed 23 or superseded and we have documentation of that to close 24 out those items.
25
54 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And then when it comes to the specific 1
regulation that were looking at in 10 C.F.R. 50.57 2
for the issuance of an operating license, what Id like 3
to highlight here thats of particular importance as 4
the staff completes its safety evaluation report, one 5
of the other key findings that needs to be made is that 6
construction has been substantially completed.
7 And this is where the licensing review and 8
construction and construction inspection all come 9
together. So once the NRC staff has completed its 10 safety evaluation report, there is still another piece 11 where once SHINE has completed its construction of its 12 facility to include at a minimum the installation of 13 all safety related structure, systems, and components, 14 there is a notification that they will make to region 15 two, which is responsible for construction inspection.
16 And once that notification has been 17 received, region two will complete and verify that their 18 inspection activities are resolved and there will be 19 a letter from the region two administrator to the 20 director of the office of Nuclear Reactor Regulation.
21 And that is the inspection piece that leads 22 into the ultimate issuance of the operating license.
23 So I did want to highlight that there. So in addition 24 to completing our review of the application there is 25
55 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the inspection piece that is necessary for the issuance 1
of the operating license.
2 When it comes to the technical areas of 3
the review, this is essentially the chapters of 4
NUREG-1537. I do note that there are some of these 5
areas that are not applicable to SHINE either at this 6
time or at all.
7 For example, looking at experimental 8
facilities, thats more common in research reactors, 9
not here for SHINE. Also SHINE is not converting from 10 HEU to LEU since they will be an LEU facility. So 11 chapter on uranium conversions is also not applicable.
12 So most of these topics were covered at 13 the construction permit stage. However, there are some 14 additional technical areas that were not presented in 15 the construction permit stage and will be presented 16 to the ACRS members for the first time.
17 Some of those that I in particular that 18 Ill highlight include a final emergency plan, a 19 physical security plan, discussions of operator 20 licensing start up, and human factors.
21 The one thing that I will note, a caveat 22 with human factors program, this is something that the 23 NRC staff is actively engaged with SHINE in to determine 24 the appropriateness of scope for human factors against 25
56 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 SHINEs design criteria.
1 We do have a regulatory audit on SHINEs 2
human factors, engineering program scheduled for 3
tomorrow where our goal coming out of that audit is 4
to have a clear idea of the necessity and scope of the 5
NRC staffs evaluation of the human factors program.
6 And I expect following that well have a clear path 7
forward on how that will be factored into the NRC staffs 8
review.
9 Going forward, I do want to highlight so 10 theres a number of audits that weve conducted that 11 have been very productive and resulted in significant 12 progress for this review related to instrumentation 13 and control systems, electrical power systems, accident 14 analysis and criticality safety, physical security, 15 and then as a result of the I&C audit we had back in 16 March, SHINE did submit a revised I&C chapter 7 as part 17 of its response to RAIs in that area in August of this 18 year.
19 And our staff is actively reviewing that 20 updated I&C chapter and I expect in the coming months 21 that we may have additional RAIs and may engage with 22 SHINE in future regulatory audits.
23 In terms of path forward on the licensing 24 review, I did mention that we do have RAIs that are 25
57 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 ready to be issued related to the accident analysis, 1
criticality safety, and chemical safety programs.
2 SHINE is also in the process of responding to previously 3
issues RAIs on external hazards and citing. And SHINE 4
has provided responses to other RAIs related to 5
instrumentation and control systems, their material 6
control and accounting program, as well as facility 7
descriptions.
8 There are some other technical areas that 9
we are looking to schedule audits likely in the December 10 and January timeframe. We need to work with SHINE on 11 specific dates for that and as well as NRC staff so 12 that we can have successful engagement.
13 Included in these are technical 14 specifications, operator licensing, fire protection, 15 and continued engagement on I&C systems. So with these 16 regulatory audits, in preparation for those, we will 17 put together technical topics that may for the basis 18 of future RAIs.
19 And coming out of these audits, the goal 20 is to have requests for additional information ready 21 for issuance to have resolved.
22 MEMBER BLEY: Hey, Steve?
23 MR. LYNCH: Yes.
24 MEMBER BLEY: I know theres going to be 25
58 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 discussion between you and Ron and maybe some others 1
about the topics at our upcoming meetings, but the first 2
ones coming in January. Which kind of things would 3
you even be prepared to talk about at that point?
4 MR. LYNCH: So thats actually something 5
I would like to talk about and need to do some internal 6
planning on how thats going to look. Probably where 7
were at, some of the high level facility descriptions 8
are probably where were mostly at. But I can skip 9
ahead to some of our proposals engaging with the ACRS.
10 One of the things that we have been 11 considering as the NRC staff is whether in order to 12 facilitate some of our discussions, if it makes sense 13 to have some of our first discussions with the ACRS 14 focused on those most safety significant items, 15 including the accident analysis, crit safety, chem 16 safety, how that relates to engineering safety 17 features, radiation and protection, looking at external 18 hazards, and grouping all of that together.
19 While we have some of that information 20 available now, we are expecting to get additional 21 information on SHINE hopefully closing out most of those 22 areas by early December, which would put us in a position 23 to have updated safety evaluation input likely in the 24 January, February timeframe.
25
59 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 So I do want to talk about with Ron and 1
Chris about what makes sense with some of these 2
presentations. Because one thing, while we can start 3
providing chapters, what I want to make sure is that 4
when were sitting in front of the members that 5
recognizing some of the interconnectedness especially 6
with some of the safety significant portions, that as 7
questions come up were able to fully respond to that 8
with the full context of completed other areas of the 9
review.
10 So that is something I do want to discuss.
11 Ive got a meeting I believe Friday morning with Chris 12 and Ron to discuss that in more detail about how we 13 want to proceed in grouping these chapters and what 14 topics are best to start discussing.
15 I know there are some areas of particularly 16 MC&A that are wrapped up and probably ready for 17 discussion, doesnt make sense to talk about that ahead 18 of some of the other areas. We can figure out what 19 makes the most sense.
20 MEMBER BLEY: Thanks. I dont want to try 21 to pin it down right now but I think you can talk with 22 our guys and get that arranged.
23 Just off the top of my head, Im thinking 24 under accident analysis, criticality safety, and 25
60 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 chemical safety, getting an as early as possible look 1
at the range of scenarios, if you will, that are being 2
considered, or events that are being considered --
3 MR. LYNCH: Yes.
4 MEMBER BLEY: -- would be a big help 5
because that could focus what comes later.
6 MR. LYNCH: Yes, absolutely. And I think 7
as part of our commitment to start getting documents 8
upload to an electronic reading room for the members, 9
having access to that SHINE safety analysis is going 10 to provide that full context of what were all of the 11 initiating events and scenarios considered by SHINE 12 that ultimately translated to the design basis 13 accidents and the controls that you see for the 14 facility.
15 And that we can have for the members in 16 the next couple weeks.
17 MEMBER BLEY: Thats great.
18 MR. LYNCH: So I think this really -- so, 19 yes, Ive got, so I think this does kind of conclude 20 the main remarks I have. I have got, yes, I have these 21 proposals of how we can group some of these chapters 22 based on safety significance and similar cross-cutting 23 areas between them that I think make sense to talk about.
24 As we prepare for these subcommittee 25
61 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 meetings I know there is a chart of looking at 1
identifying within each of these chapters what are the 2
most safety significant items were focusing on and 3
we can certainly work with SHINE and with the ACRS on 4
aligning on what those areas are so that we can put 5
together those focused presentations for the members.
6 In terms of going forward, I do want to 7
make sure that we are getting information to the ACRS 8
in a timely manner so that youre able to have sufficient 9
time to review available materials the NRC staff 10 generates, and also that SHINE has prepared either as 11 docketed material or available in an electronic reading 12 room.
13 To the extent that we need to coordinate 14 with ACRS staff as well as members ahead of subcommittee 15 meetings to make sure that were aligned on the key 16 focus areas, we are available for that and we look 17 forward to the continued engagement with the ACRS.
18 And I think with that that concludes the 19 presentation materials that I had.
20 CHAIRMAN BALLINGER: Thanks, Steve.
21 Okay, were a little bit, well, were almost there.
22 Questions from the members? I think we do have to go 23 back and open the public line for public comment.
24 So while were getting that line open, do 25
62 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 we have comments from the members?
1 Silence is golden, I guess. Is the public 2
line open, Tom?
3 MALE PARTICIPANT: Public line is open for 4
comment.
5 CHAIRMAN BALLINGER: Okay. Are there any 6
folks out on the public line that would like to make 7
a comment? Please identify yourself and make your 8
comment.
9 Okay. I dont hear any comments. Okay, 10 this pretty much ends it, ends todays session. I think 11 the last couple of slides that Steve presented are, 12 at least from my standpoint, the critical ones because 13 were having to hone in on the methodology, the path 14 forward for review by the committee, and we anticipate 15 that that will be established at the December P&P 16 meeting.
17 So thats our milestone. So I would 18 encourage members to provide feedback through Chris 19 to me, or both of us, related to this presentation and 20 anything else that you think is important for the 21 discussion in December.
22 And that pretty much ends it. So if there 23 are no other comments or questions from the members, 24 thank you very much for, to the SHINE people as well, 25
63 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 for a great presentation, and for Steve and staff to 1
do the same.
2 So I think we are five minutes late, but 3
not so bad. So thank you very much and we are adjourned.
4 (Whereupon, the above-entitled matter went 5
off the record at 1:00 p.m.)
6 7
8 9
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
SHINE Overview (Open Session)
Tracy Radel, VP of Engineering
SHINE Medical Technologies l 2 Outline (Open Session)
SHINE Site Plan Construction Status Process Overview Technological Approach Safety Philosophy
SHINE Medical Technologies l 3 Located in Janesville, WI
SHINE Medical Technologies l 4 Site Plan
SHINE Medical Technologies l 5 Site Rendering
SHINE Medical Technologies l 6 Construction Status
SHINE Medical Technologies l 7 Process Overview
- 1. Periodic solution preparation from LEU
- 2. Solution chemistry check and staging
- 3. Irradiation for 5.5 days
- 4. Extraction, purification, QC & packaging
- 5. Waste handling
SHINE Medical Technologies l 8 Technological Approach Small systems: 125 kW, hundreds of times less power than isotope production reactors being used
Low source termhelps ensure safety of public and workforce
Decay heat per system < 1 kW within 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />
Minimizes waste nuclide generation compared to reactors Low enriched uranium (LEU) reusable target
Reduces waste
Product compatible with current supply chain
Eliminates need for HEU Driven by low-energy electrostatic accelerator
Fission essentially terminate shortly after driver turned off Multiple units and trains provide operational scalability and flexibility
SHINE Medical Technologies l 9 Low decay heat, low pressure, low temperature system
Minimal stored energy Independent units limit common cause failures Operator actions are not required to mitigate the consequences of an accident In the event of an upset condition:
TSV reactivity protection system (TRPS) initiates trip of system
Two completely independent safety-related TSV dump valves open
Target solution gravity drains to the TSV dump tank (safe for all uranium concentrations)
Hydrogen concentration maintained below lower flammability limit (LFL) by off-gas system blowers Following UPS battery run time, entire plant is passively safe
90 days without cooling: pool temperature rise is not more than 13°F
Nitrogen purge system for hydrogen control Safety Philosophy
Advisory Committee on Reactor Safeguards Non-Power Production or Utilization Facility Subcommittee SHINE Medical Technologies, LLC Operating License Application Review Steven Lynch, Senior Project Manager Non-Power Production and Utilization Facility License Branch Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission November 2020
Supporting Domestic 99Mo Production
- NRC staff committed to efficient reviews of applications and inspections in accordance with the provisions of Title 10 of the Code of Federal Regulations (10 CFR)
- Licensing and oversight activities support U.S. national security interests and nuclear nonproliferation policy objectives of establishing a domestically-available and reliable supply of molybdenum-99 (99Mo) without the use of highly-enriched uranium
- Applications include initial license and license amendment requests for facilities proposing to manufacture, irradiate, and process low enriched uranium and molybdenum targets
- Oversight activities focused on preparation for construction inspection of utilization and production facilities 2
Government Coordination and Legislation
- NRC staff coordinate other federal agencies, as well as local and state governments to support initial licensing application reviews
- Department of Energy/National Nuclear Security Administration (NNSA)
- American Medical Isotopes Production Act provides for NRC and NNSA coordination on environmental reviews and the establishment of a uranium lease and takeback program
- Nuclear Energy Innovation and Modernization Act establishes three-year review period for non-power production or utilization facility initial licensing applications 3
Policy Work
- Non-Power Production or Utilization Facility License Renewal Final Rule
- Final rule submitted to the Commission on June 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML18031A001)
- Implements Commission direction to streamline the license renewal process by establishing a more efficient, effective and focused regulatory framework
- Uses innovative and transformative approaches to address existing shortcomings in the current regulations for non-power licensees, including establishing accident dose criterion and clarifying definitions
- Definition of Utilization Facility Direct Final Rule
- Final rule published in Federal Register on October 17, 2014 (79 FR 62329)
- Added definition of utilization facility to include SHINE accelerator-driven subcritical operating assemblies 4
Regulated Radioisotope Production Processes
- Target manufacturing
Preparation of low enriched uranium (LEU) targets for irradiation
- Target irradiation
Nuclear reactors
Subcritical operating assemblies
Accelerators
- Target processing
Hot cell separation of 99Mo from irradiated LEU targets
- Medical uses of byproduct material
Generators for extracting technetium-99m from 99Mo 5
Similarities to Existing Facilities
- Safety considerations comparable non-power reactors:
Fission heat removal Decay heat generation Fission gas release
- and fuel cycle facilities:
Target manufacturing Radiation protection Material processing Fission product buildup Accident scenarios Criticality control Chemical hazards 6
Responsibilities and Coordination
- The Division of Advanced Reactors and Non-Power Production and Utilization Facilities (DANU) is responsible, in part, for initial licensing activities associated with NPUFs licensed under 10 CFR Part 50.
- The following types of facilities may be licensed as commercial or research and development facilities under Sections 103 or 104 of the Atomic Energy Act, respectively:
Non-Power Reactors, including advanced reactor technologies Subcritical Operating Assemblies Production Facilities
- NRR relies on the expertise and support of other offices in the following technical areas to review medical radioisotope facility applications:
7 Emergency Planning Physical Security Environmental Financial Qualifications Material Control and Accounting Accident Analysis Chemical safety Criticality Safety
Policy Work
- Non-Power Production or Utilization Facility License Renewal Final Rule
- Final rule submitted to the Commission on June 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML18031A001)
- Implements Commission direction to streamline the license renewal process by establishing a more efficient, effective and focused regulatory framework
- Uses innovative and transformative approaches to address existing shortcomings in the current regulations for non-power licensees, including establishing accident dose criterion and clarifying definitions
- Definition of Utilization Facility Direct Final Rule
- Final rule published in Federal Register on October 17, 2014 (79 FR 62329)
- Added definition of utilization facility to include SHINE accelerator-driven subcritical operating assemblies 8
SHINE Medical Technologies Background
- NRC received two-part construction permit application
Environmental Report (March 26, 2013)
Preliminary Safety Analysis Report (May 31, 2013)
- SHINE proposes to produce 99Mo from fission of low enriched uranium target solution in Irradiation Facility consisting of 8 irradiation units
- 99Mo recovered through irradiated target solution processing in Radioisotope Production Facility consisting of 3 hot cells
- Construction permit issued on February 29, 2016
- Construction commenced in September 2019
- Site: Janesville, WI 9
Periodic Reports on Permit Conditions
- Section 3.D.(1) of SHINE construction permit requires the submission of periodic reports to verify certain design elements related to nuclear criticality safety and radiation protection
Criticality accident alarm system
Nuclear criticality safety evaluations
Design information demonstrating shielding and occupancy times consistent with as low as reasonably achievable practices and dose requirements
- These reports generally supported potential construction inspection activities prior to the submission of an operating license application
- NRC staff reviewing current information final safety analysis report, as supplemented.
10
Licensing Overview: SHINE Irradiation Facility
- Irradiation facility houses eight subcritical irradiation units, which are comparable in power level and safety considerations to existing non-power reactors licensed under 10 CFR Part 50
- However, due to subcriticality, irradiation units did not meet the existing definition of utilization facility in 10 CFR 50.2 and could not be licensed under 10 CFR Part 70
- To align licensing process with potential hazards, NRC issued direct final rule modifying 10 CFR definition of utilization facility to include SHINE irradiation units
Published October 17, 2014
Effective December 31, 2014 11
Licensing Overview:
SHINE Radioisotope Production Facility
- Radioisotope Production Facility consists of three hot cells for 99Mo separation and purification
- Based on batch size (i.e., greater than 100 grams), facility meets the definition of a production facility as defined in 10 CFR 50.2, Definitions
- While NRC has historically licensed production facilities, no such facilities currently operating
- Few previously-licensed facilities have conducted similar activities as SHINE
Cintichem (licensed under 10 CFR Part 70)
West Valley (licensed as a reprocessing facility) 12
SHINE General Licensing Approach
- SHINE requested single operating license under 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities Irradiation units licensed as utilization facilities Hot cells licensed as production facility
- Special nuclear material will be licensed under 10 CFR Part 70, Domestic Licensing of Special Nuclear Material
- Source material to be licensed under 10 CFR Part 40, Domestic Licensing of Source Material 13
SHINE Operating License Application
- SHINE submitted operating license application on July 17, 2019
- Operating license application accepted for review on October 8, 2019, noting the following areas that would require focused engagement with the NRC staff (ADAMS Accession No. ML19276D409):
- Instrumentation and Control Systems
- Accident Analysis and Methodologies
- Following public meetings and regulatory audits on these technical review areas, a schedule of 24 months was established in April 2020 (ADAMS Accession No. ML20114E315) 14
Similar review process for construction permit and operating license applications:
Acceptance and docketing review Parallel safety and environmental reviews o Construction permit: preparation of safety evaluation report (SER) and environmental impact statement (EIS) (or environmental assessment) o Operating license: preparation of SER and supplemental EIS (or environmental assessment)
Request(s) for additional information, as needed Advisory Committee on Reactor Safeguards (ACRS) review Hearing(s) o Construction permit and operating license: potential for contested hearing(s) o Construction permit: mandatory hearing on sufficiency of staff safety and environmental reviews Decision to grant or deny permit or license 15 10 CFR Part 50 Licensing Process
- Safety reviews for construction permit and operating license applications conducted in accordance with Commissions regulations
- The level of detail needed in a construction permit application and NRC staffs SER different than for combined operating license or operating license The PSAR includes preliminary design of the facility, while the FSAR includes final design of the facility, as well as plans and programs not provided in PSAR
- Staffs review tailored to unique and novel technology described in construction permit application using appropriate regulatory guidance NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors Interim Staff Guidance Augmenting NUREG-1537 Other guidance (e.g., regulatory guides and industry standards) and engineering judgment used, as appropriate 16 NRC Safety Review Methodology
Review Approach In order to focus resources and efficiently complete the review of the SHINE operating license application, the staff is applying a tiered review strategy. Technical areas within the application are assigned review levels corresponding to scheduled milestones based on the complexity of the subject matter, availability of information, and maturity of design.
The review levels are defined as:
- Level 1: No clarification questions needed, information readily available, direct preparation of requests for additional information (RAIs)
- Level 2: Initial clarification questions needed, reference documents requested, and public meetings needed prior to developing RAIs
- Level 3: Fundamental scoping questions, clarification questions, public meetings, audits, and application supplements needed prior to developing RAIs Review Strategies:
Use of focused review groups Leverage scaled review methodologies Exchange of technical and licensing expertise Establish clear responsibilities to ensure responsiveness and timeliness 17
Basis for Issuing Construction Permit
- The following findings must be made to issue a construction permit, based on 10 CFR 50.35:
Facility has been described, including the principal architectural and engineering criteria for the design
Further technical or design information may be reasonably left for later consideration in the FSAR
Safety features or components requiring research and development have been identified
Safety questions will be resolved prior to the completion of construction and the proposed facility can be constructed without undue risk to the health and safety of the public
- Staffs conclusions also based on the considerations in 10 CFR 50.40 and 50.50 18
Basis for Issuing Operating License
- The review of the operating license application is not a delta review of the construction permit application
- NRC staff consider commitments made by the applicant in Appendix A to the construction permit Safety Evaluation Report in preparing requests for additional information
- The following findings must be made to issue a construction permit, based on 10 CFR 50.57:
Construction has been substantially completed
Facility will operate in conformity with application and regulations
Reasonable assurance that operation will not endanger public health and safety
Applicant technically and financially qualified
Provisions of 10 CFR Part 140 satisfied
Issuance of license will not be inimical to common defense and security 19
NUREG-1537 Review Areas 1.
The Facility/Introduction 2.
Site Characteristics 3.
Design of Structures, Systems, and Components 4.
Facility Description 5.
Coolant Systems 6.
Engineered Safety Features 7.
Instrumentation and Control 8.
Electrical Power Systems 9.
Auxiliary Systems
- 10. Experimental Facilities*
- 11. Radiation Protection and Waste Management
- 12. Conduct of Operations Emergency Planning Physical Security Operator Licensing Startup Plan Human Factors Quality Assurance
- 13. Accident Analysis
- 14. Technical Specifications
- 15. Financial Qualifications
- 16. Other License Considerations*
- 17. Decommissioning*
- 18. Uranium Conversions*
- 19. Environmental Review
- Not applicable to the SHINE operating license application 20
Review Status Recent Milestones Achieved:
Conducted instrumentation and control audit (March 2020)
Conducted electrical power systems audit (May 2020)
Conducted accident analysis and criticality safety audit (August 2020)
Conducted security audit (September 2020)
Received revised Instrumentation and Control Chapter 7 (August 2020)
Upcoming Milestones:
Conducting human factors and startup plan audit (November 2020)
Conducting technical specification audit (TBD)
Conducting operating licensing audit (TBD)
Conducting fire protection audit (TBD)
Conducting additional instrumentation and control audit (TBD) 21
Review Schedule In April 2020, staff established shortened 24-month review schedule and resource estimate of 22,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> based on availability of additional information on SHINEs accident analysis and instrumentation and control (I&C) systems Milestone Est. Completion Date Actual Completion Date Status Acceptance and Docketing of Application October 2019 October 2019 Complete ACRS Subcommittee Planning Meeting October 22, 2020 TBD Pending ACRS Subcommittee Meeting November 4, 2020 TBD Pending Publication of Draft EIS Supplement January 2021 TBD Pending Publication of Final EIS Supplement August 2021 TBD Pending Draft Safety Evaluation Complete July 2021 TBD Pending ACRS Full Committee Meeting September 2021 TBD Pending Final Safety Evaluation Report Complete September 2021 TBD Pending Final Determination on Issuance of Operating License October 2021 TBD Pending 22
Project Risks Technical Risks Schedule Risks Cost Risks None at this time Policy Risks None at this time Risk Risk Level Mitigation Potential design changes, including development of I&C systems Moderate Outside of NRC staff control Revision of physical security plan Moderate Staff working with SHINE on receiving revision to avoid unnecessary RAIs Staff turnover following closeout of review areas ahead of overall project completion Moderate 1.
Closeout ACRS actions within 90 days of subcommittee meetings 2.
Identify and resolve legal questions early SHINE timeliness in responding to RAIs Moderate Staff coordination with SHINE to ensure draft RAIs are well-understood and reasonable response timeframes are established SHINE completion of construction Moderate Outside of NRC staff control Risk Risk Level Mitigation SHINE development of I&C systems delays due to revision of FSAR in August 2020 Moderate Engagement with SHINE to align on what information is most safety-significant 23
ACRS Subcommittee Engagement
- Present on technical topics based on safety-significance and relation to other topics
- Present on technical topics only after NRC staff has resolved all open items with licensee
- Staff propose three subcommittee meetings, organized by the safety-significance of technical areas, covering all chapters of the application
- Prior to scheduled subcommittee meetings, staff will identify most safety significant areas within each topic that merit focused discussion
- For areas that dont require focused technical discussion, staff and applicant will be prepared to answer questions, but may not have prepared materials 24
ACRS Subcommittee Engagement (Continued)
Subcommittee Topic Grouping 1:
Facility Description (Chapters 1, 4)
Accident Analysis (Chapter 13)
Criticality Safety (Chapter 6, 13)
Chemical Safety (Chapter 4, 13)
Engineered Safety Features (Chapter 6)
Site Characteristics and External Hazards (Chapters 2, 3)
Radiation Protection and Waste Management (Chapter 11)
Subcommittee Topic Grouping 2:
Instrumentation and Control Systems (Chapter 7)
Electrical Power Systems (Chapter 8)
Coolant Systems (Chapter 5)
Conduct of Operations (Chapter 12)
Emergency Planning Physical Security Operator Licensing Startup Plan Human Factors Quality Assurance Subcommittee Topic Grouping 3:
Technical Specifications (Chapter 14)
Follow-up items 25
Success Strategies Early and frequent engagement with SHINE Leverage use of electronic reading room, audits, public meetings, and clarification calls to improve understanding of application Leverage Technology Use of electronic reading rooms, virtual meetings Communication at all levels Communicate and align on key messages and review approaches across offices and at all organizational levels Communicate review status and key milestones with Advisory Committee on Reactor Safeguards 26