ML16083A106

Transcript of Public Meeting with Northwest Medical Isotopes on February 18, 2016, Pages 1-176

ML16083A106
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	02/18/2016
From:	Michael Balazik NRC/NRR/DPR/PRLB
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ML16083A110	List: ML16083A106 ML16083A107
References
NRC-2177
Download: ML16083A106 (177)

Text

Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

Meeting with Northwest Medical Isotopes Docket Number: 50-609 Location: Rockville, Maryland Date: Thursday, February 18, 2016 Work Order No.: NRC-2177 Pages 1-176 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 (202) 234-4433

1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 + + + + +

4 PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC 5 + + + + +

6 THURSDAY, 7 FEBRUARY 18, 2016 8 + + + + +

9 ROCKVILLE, MARYLAND 10 + + + + +

11 The Public Meeting commenced in Room O-12 16B4, One White Flint North, 11555 Rockville Pike, at 13 8:30 a.m., Mike Balazik, Project Manager, presiding.

14 15 NRC STAFF PRESENT:

16 LAWRENCE KOKAJKO, Director, Division of Policy and 17 Rulemaking, Office of Nuclear Reactor 18 Regulation 19 WILLIAM DEAN, Regional Administrator, Region I 20 CRAIG ERLANGER, Acting Director, Division of Fuel 21 Cycle Safety, Safeguards, & Environmental 22 Review, Office of Nuclear Material Safety and 23 Safeguards 24 MICHELE EVANS, Deputy Director, Office of Nuclear 25 Reactor Regulation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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2 1 JANE MARSHALL, Deputy Director, Division of License 2 Renewal, Office of Nuclear Reactor Regulation 3 MICHAEL BALAZIK, Project Manager, Division of Policy 4 and Rulemaking, Office of Nuclear Reactor 5 Regulation 6 ALEXANDER ADAMS, Chief, Research and Test Reactors 7 Licensing, Office of Nuclear Reactor 8 Regulation 9 MIRELA GAVRILAS, Deputy Director, Division of Policy 10 and Rulemaking, Office of Nuclear Reactor 11 Regulation 12 SHANA HELTON, Acting Deputy Division Director, 13 Division of Fuel Cycle Safety, Safeguards &

14 Environmental Review, Office of Nuclear 15 Material Safety and Safeguards 16 ROBERT JOHNSON, Chief, Fuel Manufacturing Branch, 17 Office of Nuclear Material Safety and 18 Safeguards 19 STEVE LYNCH, Project Manager, Research and Test 20 Reactors Licensing Branch, Office of Nuclear 21 Reactor Regulation 22 NANCY MARTINEZ, Environmental Project Manager, 23 Office of Nuclear Reactor Regulation 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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3 1 DAVE TIKTINSKY, Project Manager, Fuel Manufacturing 2 Branch, Office of Nuclear Material Safety and 3 Safeguards 4

5 ALSO PRESENT:

6 NICHOLAS FOWLER, Chief Executive Officer, NWMI 7 CAROLYN HAASS, Chief Operating Officer, NWMI 8

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4 1 T-A-B-L-E O-F C-O-N-T-E-N-T-S 2 Page 3 Opening Remarks by NRC Staff 4 Michael Balazik . . . . . . . . . . . . . . 6 5 Mirela Gavrilas . . . . . . . . . . . . . . 13 6 Shana Helton . . . . . . . . . . . . . . . 14 7 Opening Remarks by Northwest Medical Isotopes 8 Nicholas Fowler . . . . . . . . . . . . . . 15 9 NRC Licensing Processes 10 10 CFR Part 50, General 11 Steve Lynch . . . . . . . . . . . . . . . . 20 12 10 CFR Part 51, Environmental 13 Nancy Martinez . . . . . . . . . . . . . . 36 14 10 CFR Part 50, Construction & Operating License 15 Steve Lynch . . . . . . . . . . . . . . . . 42 16 NRC Licensing Process, Part 70 17 Dave Tiktinsky . . . . . . . . . . . . . . 90 18 Licensing Review Request (NWMI licensing request and 19 NRC understanding of request - NRC/NWMI) 20 Al Adams . . . . . . . . . . . . . . . . 113 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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5 1 Communications (NRC/NWMI) 2 Michael Balazik . . . . . . . . . . . . . 126 3 Steve Lynch . . . . . . . . . . . . . . . 130 4 Al Adams . . . . . . . . . . . . . . . . 134 5 Dave Tiktinsky . . . . . . . . . . . . . 135 6 NWMI Topics for Discussion . . . . . . . . . . 141 7 Closing Remarks/Summary . . . . . . . . . . . . 155 8 Adjourned . . . . . . . . . . . . . . . . . . . 176 9

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6 1 P-R-O-C-E-E-D-I-N-G-S 2 (8:33 a.m.)

3 MR. BALAZIK: All right, good morning.

4 I'd like welcome everyone in attendance today. My 5 name is Mike Balazik. I'm a project manager in the 6 Division of Policy and Rulemaking at the NRC.

7 Northwest Medical Isotopes has agreed to 8 meet with the NRC staff today to discuss licensing for 9 their radio isotope facility.

10 This is a Category 1 public meeting 11 conducted in accordance with the Commission's Police 12 Statement on enhancing public participation in NRC 13 meetings. As such is intended to be a dialogue 14 between the NRC and Northwest Medical Isotopes 15 concerning topics related to licensing in Northwest 16 Medical Isotope facility project.

17 The public in invited to observe the 18 meeting and will have the opportunity to communicate 19 with the NRC staff after the business portion of the 20 meeting, but before the meeting is adjourned.

21 Northwest may respond to comments or questions from 22 the public but is not obligated to do so.

23 When we go through the introductions I ask 24 everybody identify yourself and your affiliation.

25 There's a sign-in sheet that may be moving around the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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7 1 room right now. I ask everyone sign in. Yes, thank 2 you.

3 If you wish to provide any comments on the 4 meeting, I can provide you a meeting feedback form.

5 Or you can also go to the public meeting cite and do 6 it electronically.

7 This meeting is scheduled to last till 8 approximately 3:00 p.m. I'd like to emphasize that 9 this meeting is primary for the NRC to discuss general 10 licensing processes and reviews, the NRC regulations 11 and guidance with the Northwest. There are no 12 regulatory decisions will be made at this meeting.

13 Also, as a reminder, this meeting is being 14 transcribed today. And for everybody on the phone, 15 the slide presentation is available. It's publically 16 available. And I'm going to provide the NO number 17 right now for everyone. The number is ML16048A, as in 18 Alpha, 554.

19 Does anybody on the phone need that 20 repeated? All right, I'm not hearing any.

21 (Off record comment) 22 MR. BALAZIK: All right, I'll continue on.

23 A meeting summary will be made publically available 24 within 30 days of this meeting.

25 Before we begin, a couple of items I'd NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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8 1 like to mention. First of all, please limit 2 interruptions. Silence your cell phone and please 3 keep side conversations to a minimum.

4 I ask you speak one at a time. And 5 individuals on the phone, please mute your phone 6 unless you're going to provide any comment.

7 Also, please identify yourself when you 8 speak so people on the phone knows who's speaking.

9 And again, submit any questions or comments to me at 10 mfb@nrc.gov.

11 Next I'd like to remind you that you're 12 within a NRC controlled space. Should there be an 13 emergency all occupants should begin to calmly 14 evacuate using the nearest stairwell to exit the 15 building.

16 All visitors will be escorted by the NRC 17 staff. Disables persons, who due to health reasons 18 feel they cannot safety walk down the stairs to 19 evacuate, may use the elevators. Exit through the 20 nearest door and then go to the pause area in front of 21 One White Flint and report their presence with the 22 guard.

23 So you experience, observe anyone with a 24 life threatening medical complaint while evacuating, 25 call 911 and report your location and nature of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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9 1 emergency.

2 Also, if you need to use the restroom, 3 you'll need to be escorted.

4 All right. So let's now run though 5 introductions. I'd ask everyone to speak loudly so 6 people on the phone can here you. And let's start 7 around the table.

8 As I said earlier, my name is Mike 9 Balazik. I'm a Project Manager in Division of Policy 10 and Rulemaking.

11 MS. MARTINEZ: Good morning. I'm Nancy 12 Martinez, NRC Environmental Project Manager.

13 MS. GAVRILAS: Mirela Gavrilas, Deputy 14 Director, Division of Policy and Rulemaking in NRR at 15 the NRC.

16 MR. LYNCH: This is Steve Lynch. I'm a 17 Project Manager with Research and Test Reactors.

18 And real quick, before we go on with the 19 introductions, if you are participating on the phone, 20 could you please put your phone on mute? We're 21 getting a lot of feedback in the room here. Thank 22 you.

23 MR. ADAMS: Al Adams, Chief of Research 24 and Test Reactor Licensing, NRC.

25 MR. TIKTINSKY: Dave Tiktinsky, Project NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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10 1 Manager of the Field Manufacturing Branch in Office of 2 Nuclear Material Safety and Safeguards.

3 MR. JOHNSON: Good morning. Robert 4 Johnson, Fuel Manufacturing Branch Chief, NMSS.

5 MS. HELTON: Shana Helton, Acting Deputy 6 Division Director at Fuel Cycle NMSS.

7 MR. FOWLER: Nick Fowler, the Chief 8 Executive Officer of Northwest Medical Isotopes.

9 MS. HAASS: Carolyn Haass, Chief Operating 10 Office, Northwest Medical Isotopes.

11 MS. KEIM: Andrea Keim, Vendor Inspection 12 and Quality Assurance, NRR.

13 MR. MATULA: Tom Matula, NMSS, Project 14 Manager.

15 MR. MORRISSEY: Kevin Morrissey, Fuel 16 Cycle Review.

17 MS. ADAMS: Mary Adams, Fuel Cycle Safety 18 and Environmental Review.

19 MS. LONDON: Lisa London, Office of 20 General Counsel.

21 MS. BIELECKI: Jessica Bielecki, Office of 22 General Counsel.

23 MR. LINDELL: Joseph Lindell, Office of 24 General Counsel.

25 MS. KANATAS: Catherine Kanatas, Office of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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11 1 General Counsel.

2 MS. YOUNG: Mitzi Young, Office of the 3 General Counsel.

4 MS. TRAN: Linh Tran, Research and Test 5 Reactor Licensing Branch, NRC.

6 MR. ALLEN: Eben Allen, Research and Test 7 Reactor, Project Manager.

8 MR. BALAZIK: This is Mike Balazik, please 9 mute your phones. Somebody's got an open line and 10 they're speaking and we're hearing you in the room.

11 MR. LYNCH: Star 6.

12 MR. DANNA: Jim Danna, NRR, Division of 13 License Renewal.

14 MR. MILLER: Chris Miller, Office of 15 Nuclear Reactor Regulation. And I'm the Director of 16 the Division of License Group.

17 MR. ISAAC: Patrick Isaac, Research 18 Reactor Oversight Branch.

19 MR. BALAZIK: All right, this is Mike 20 Balazik again. Let's go to the phone line. I ask 21 individuals to identify themselves.

22 MR. RODRIGUEZ: Michael Rodriguez, NRC, 23 NSIR EP.

24 MR. FLAGG: Michael Flagg, University of 25 Missouri Research Reactor.

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12 1 MS. MCCULLOUGH: Kara McCullough, NSIR, 2 NRLB.

3 MR. BERICK: Dave Berick with Senator Ron 4 Wyden.

5 MS. RIVERA: Alison Rivera, NSIR EP.

6 MS. BANERJEE: Good morning. Maitri 7 Banerjee, ACRS Staff.

8 MS. WEIL: Jenny Weil, Congressional 9 Affairs.

10 MS. FRAZIER: Andy Frazier, Region III 11 Office.

12 MS. MOSER: Michelle Moser, Environmental 13 Energy Staff.

14 MR. BARTELME: Jeff Bartelme, SHINE 15 Medical Technologies.

16 MR. NAQUIN: Ty Naquin, NMSS, Fuel 17 Manufacturing Branch.

18 MR. TEAL: Charles Teal, NSIR Fuel Cycle 19 Transportation Security Branch.

20 MR. FOLK: Kevin Folk, NRC Environmental 21 Staff.

22 MR. WEBER: Carl Weber, NRC, Office of New 23 Reactors.

24 MR. BALAZIK: Is there anybody else on the 25 phone that wishes to identify themselves? Okay, I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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13 1 hearing none.

2 So now I'd like to turn it over to Mirela, 3 who would like to provide some opening remarks.

4 MS. GAVRILAS: Thank you, Mike. Welcome 5 everyone. I want to start out with a very high level 6 statement which is, that we, the Agency, recognize the 7 importance of establishing a reliable domestic supply 8 of molybdenum-99.

9 And as such, we recognize our role to 10 support that national effort. So you will see, you 11 will hear today about what we do and how we do it and 12 why we do it.

13 And you'll also hear, you see already that 14 the room is filled with technical experts and with 15 regulatory experts who are here to answer all your 16 questions. Because the main objective of this meeting 17 is to obtain clarity in our communications.

18 It is very important to us that we hear 19 each other correctly. Because we realize that every 20 time we take time out to clear out misunderstanding, 21 we spent resources and time that would be better spent 22 moving the review and the effort forward.

23 So our main objective today is basically 24 to discuss the topics that we agreed with Northwest 25 Medical, should be discussed today. And we want to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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14 1 have open dialogue. So please ask questions at any 2 time.

3 Again, we have the technical and the 4 regulatory experts in the room to address your 5 questions. So we want to make sure that at the end of 6 the meeting, we're aligned in terms of our 7 understanding of where we are in terms of the review 8 of the construction permit that's in front of us now, 9 as well we the preview of the operating license that 10 is still to come.

11 So with that, I'm going to pass it to 12 Shana who is going to give a couple of additional 13 opening remarks.

14 MS. HELTON: Thanks, Mirela. I agree with 15 Mirela's points. I can't emphasize enough the need to 16 obtain clarity on both sides, so that we can have an 17 efficient, effective licensing path forward.

18 And to that end, I just want to say, that 19 while multiple offices are involved with this review, 20 we do act as one NRC. You will hear from us with one 21 voice.

22 Mike Balazik will be your primary point of 23 contact. So you don't have to worry about trying to 24 correlate between different offices.

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15 1 that I wanted to emphasize is that for each 2 application that we receive as an Agency, not just in 3 this area of medical isotopes, we review each 4 application based on its merits.

5 So really we need to look at what's before 6 us today. And as we go through the construction 7 permit, that will be one aspect of the review.

8 One goal, on our end, is to really gain 9 clarity on the nature of any of your future 10 submittals, since you've indicated that some of your 11 activities would be regulated under Part 70 and under 12 Part 30. So I look forward to learning more about 13 that path forward as well.

14 So with that, you know, I just look 15 forward to having a good meeting. Thank you for 16 coming here today. And for everybody on the phone.

17 MR. BALAZIK: This is Mike Balazik. Thank 18 you, Shana. Now I'll turn it over to Northwest 19 Medical Isotopes for some opening remarks.

20 MR. FOWLER: Well, and I would add my 21 thanks to everyone that's assembled here. In that we 22 all understand the importance of serving a reliable 23 and secure supply within the United States for moly-24 99.

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16 1 his direct staff and a number of folks who are in this 2 room a month ago. And we believe, Northwest Medical 3 Isotopes believe, it was an excellent conversation.

4 Part of a long-term relationship building exercise to 5 make these conversations as productive as possible.

6 We invited with us, a couple of people to 7 provide perspective. One of whom was the chief 8 executive officer of a leading healthcare services 9 provider in the United States.

10 And we all recognize the need for this 11 reliable supply of moly in the United States. But 12 sometimes hearing it from a healthcare services 13 provider that's responsible for millions of people, 14 who can provide that direct testimony of what it means 15 when there are shortages, is important. And we 16 thought that important to provide that direct 17 perspective into the executive meeting a month ago.

18 We also invited Mallinckrodt to speak on 19 the state of the supply chain. And what is coming 20 forward in the near future and the potential fragility 21 of that supply chain that really puts a point on why 22 these activities that are before the NRC are so 23 important.

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17 1 specifically. And we hope that this meeting today 2 directly addresses those two questions as follow up to 3 that meeting.

4 The first had to do with the licensing 5 approach as our activities do incorporate both Part 50 6 and Part 70 activity in our intended operations.

7 And the other was recognizing the need for 8 this domestic supply, exploring mechanisms by which 9 the review schedule can be accelerated, expedited, 10 done in the most productive fashion possible.

11 And we are committed to not only 12 understanding the process of the NRC and being 13 extremely responsive to that process, but also doing 14 everything we can possibly do to make that review as 15 expeditious as possible. And we hope to have that 16 kind of conversation today to understand how we might 17 work better together to get the review done and as 18 quickly as possible, without compromising our combined 19 committee to public safety, as well as public health.

20 And so I did have the opportunity on the 21 nine hour trip yesterday, in the care of one of our 22 major airlines, to review the materials that Mike had 23 provided to Carolyn in advance.

24 And in the interest of everybody's time 25 assembled, I think the package is great from an NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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18 1 educational standpoint. I think we understand largely 2 the background.

3 And so perhaps going through the general 4 information as quickly as possible, and getting 5 specifically more to those two follow up items, could 6 save us all some time. Because we have reviewed all 7 the guidance from the NRC. We've reviewed the general 8 information.

9 And so getting quickly to the areas of 10 combined interest is certainly our objective here.

11 So, Michael, thank you very much for providing the 12 materials early.

13 And with that, I'd like to turn it back to 14 the NRC to begin this, what we all hope, to be a very 15 productive meeting.

16 MR. BALAZIK: Thank you, Nicholas, I 17 appreciate that.

18 MS. GAVRILAS: So just one comment. The 19 slides that you have, we really appreciated the fact 20 that you reviewed them before we're going to talk 21 about them.

22 They're intended to engage you in dialogue 23 with us. They're intended to basically, we're talking 24 in general, and you may want to take the opportunity 25 to ask, how does this impact us.

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19 1 What we're trying to understand is, not 2 just what your questions are, but why you asked those 3 questions. Because we want to make sure that we're 4 answering, not just the words, but the intent of what 5 you're trying to find out.

6 So again, thank you for going through 7 them, this is great. It seldomly happens. And we'll 8 just use them as context for the rest of the 9 discussion. So please, at any time, just stop us and 10 talk to us about everything. Thanks.

11 MR. BALAZIK: All right, this is Mike 12 Balazik again. First of all, for transcription 13 purposes, please identify yourself prior to speaking.

14 And let's start the presentation.

15 One item that I'd like to add is that no 16 proprietary materials planned to be discussed by this 17 staff during this meeting. However, if Northwest 18 Medical Isotopes believes that we are starting to move 19 in that direction, please let us know so that we can 20 cut off the discussion right there. So thank you.

21 All right, these -- here's the staff 22 that's presenting today. Earlier we've all identified 23 ourselves so we'll go through these slides real quick.

24 Basically this is the meeting purpose.

25 Here's some of the main topics we want to cover today.

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20 1 Just provide a general overview of the NRC, oops, I'm 2 sorry. It skipped one on me.

3 Provide an overview of NRC licensing 4 processes, provide an overview of NRC regulations and 5 guidance for construction permit operating license and 6 a Part 70 license, as well as a 30 license. Discuss 7 review timeline. Provide status of the construction 8 permit application review and discuss communications.

9 Okay?

10 And next we'll go into the licensing.

11 MR. LYNCH: Sure. This is Steve Lynch.

12 And just to give myself a little bit more of an 13 introduction.

14 For those who don't know, I was involved 15 with the SHINE review and was the lead projector 16 manager for that. So I'm helping out with the 17 Northwest review to provide insights and input to help 18 gain efficiencies and lessons learned from previous 19 reviews that we've done. And apply them.

20 And that's what we try doing at the NRC.

21 Is we've done something before, hopefully the next 22 time we do it we can apply the lessons learned from 23 before.

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21 1 and the NRC. We want to emphasis that where we pick 2 the licensing process from the regulations is driven 3 by the technology that's put in front of us.

4 And especially with the medical isotope 5 facilities. Some of the considerations that we look 6 at are, how much material are you going to have, what 7 types of material will be onsite.

8 That will help determine where you fall in 9 the regulations, the activities that you're actually 10 going to be performing with this material.

11 Are you going to be making targets, are 12 you going to be irradiating targets, will you be 13 processing targets. How will you be irradiating your 14 targets. Will you be using a nuclear reactor. Will 15 an accelerator be involved.

16 Then we also look at the, how you're going 17 to be processing the targets afterwards. And the 18 bigger driver for licensing regimes there is, looking 19 at the batch size.

20 As I'm sure you're very well aware, if 21 you're processing batches of greater than 100 grams of 22 special nuclear material, that will put that activity 23 into the Part 50 licensing process.

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22 1 facilities. And as I understand with Northwest, it 2 will be a mixture of both. Using existing research 3 reactors as well as constructing a new facility for 4 processing.

5 Next slide. So once we've looked at all 6 the technology and how you're going to be using the 7 material, the next step is to try putting it into the 8 different boxes we have in our regulations.

9 These are not all of the regulations that 10 you need to follow in order to get a license. But 11 these, in terms of the application that you provided, 12 are some of the main technological boxes that we'll be 13 looking at in terms of licensing the production 14 facility in Part 50.

15 The special nuclear material will be 16 looked at under Part 70. The moly that's produced 17 we'll be looking at under Part 30.

18 And then with all of this, we'll be 19 looking at the environmental impacts of these actions 20 and how the material will be used.

21 Next slide. So we're going to spend today 22 highlighting some of the different processes that we 23 use from that previous slide. Especially focusing on 24 Part 50, for the production facility, Part 70, for 25 material. And then also Part 51 for the environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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23 1 review process.

2 And we just kind of want to step through 3 these processes to see if you have any questions about 4 how we are conducting the review of the application 5 that you've provided us.

6 So we'll get started with an introduction 7 to how we're looking to have a Part 50. In order to 8 go through the Part 50 and licensing process, there 9 are two licenses that you will need to apply for and 10 get from the NRC in order to operate your facility.

11 And that's a construction permit, which 12 you have applied for, and an operating license that we 13 will look forward to reviewing, if you choose to 14 submit one.

15 The main components of the construction 16 permit are the environmental report and the 17 preliminary safety analysis report. You've submitted 18 both of those, so you're familiar with their content.

19 And then for the operating license 20 application, we'll be looking at your final safety 21 analysis report, which includes more information, and 22 was in your PSAR. Including your plans for operation, 23 handling emergencies and your technical 24 specifications.

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24 1 license application will be the Physical Security 2 Plan.

3 Our commitment to doing these reviews, for 4 both the construction permit and the operating 5 license, is to finish these reviews within a year and 6 a half to two years from docketing the application.

7 Based on the experience that we have 8 recently with applications like this, we believe that 9 we can meet that review schedule.

10 Yes, we're going to go into more detail 11 about ways that we can, that factors that may 12 accelerate or hinder our ability to meet this.

13 Next slide. So today we'll focus mostly 14 on the regulations and licensing surrounding 15 construction permits. Since that's the application 16 that we have in-house.

17 If you would like to gain better 18 understanding of the operating license review process, 19 we can certainly discuss that in a future meeting.

20 For here, I wanted to highlight some of 21 the more important regulations concerning the 22 construction permit. This is highlighting the main, 23 you know, 50.22 puts you into the realm of the 24 commercial facility under the Atomic Energy Act.

25 That's Section 103.

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25 1 And as I'm sure you're aware, this is 2 slightly different than most of the other non-power 3 facilities that we license under Part 50. Those are 4 generally research reactors that are non-commercial 5 facilities.

6 And the main difference that we see there 7 is that there will be a mandatory hearing on your 8 application. And there will be a review by the ACRS 9 as well.

10 The other, some of the other things that 11 you're aware of under 50.30, you're to submit an 12 environmental report, which you have done. And submit 13 a preliminary safety analysis report under 50.34, also 14 what you have done.

15 And then some of the other important 16 regulations that you address in your accident analysis 17 are meeting both occupational and public dose 18 requirements under Part 20.

19 All right, then after we finished our 20 review of your application, what the NRC is fighting 21 to come to a conclusion is, can you construct your 22 facility as described in your PSAR?

23 And what we're looking at there are these 24 regulations that I have listed at the end there.

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26 1 slide, as far as the findings that the commission 2 needs to make in order to issue a construction permit.

3 And those are supported also by the findings that are 4 in 50.40, 50.42 and 50.50.

5 Next slide. So as the NRC evaluates your 6 application, these are the primary four findings that 7 we are looking to make, based on the information that 8 you have provided.

9 We'll look at, to see, have you provided 10 the proposed facility design. And the emphasis here 11 is, what we're looking at for is, have you given us 12 your principle design criteria in this first bullet.

13 As you're aware, 50.34(a) does require 14 that you describe your principle design criteria.

15 Unlike nuclear power reactors, the principle design 16 criteria are not enumerated in Appendix A of Part 50.

17 And that you are left to propose your own design 18 criteria per your facility in this case.

19 We also recognize that we are being 20 provided a preliminary design. And as such, there may 21 be information that you have not provided at this 22 time.

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27 1 in order to establish a preliminary design.

2 Something else, 50.34(a)(8) allows ongoing 3 research and development through construction. For 4 those areas that you've identified that you have 5 ongoing research and development, we'll be looking to 6 see that you have a research and development program 7 developed and setup in order to resolve any safety 8 questions associated with those items.

9 And then all this comes down to, that we 10 need reasonable assurance, that prior to the 11 completion of construction, any safety questions that 12 are opened, will be resolved in the interest of public 13 health and safety.

14 Next slide. So this slide, what I wanted 15 to emphasize is the difference between the 16 determinations that we're making at the construction 17 stage and at the operating license stage.

18 At the construction stage, we're 19 essentially only -- we're allowing you to go forward 20 and construct. You've given us enough information for 21 us to say, go ahead and get started.

22 In contrast, when we issue an operating 23 license, this is when we say that, based on the final 24 design of the facility, that we believe it can be 25 operated safety. So I just wanted to emphasize the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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28 1 difference in the emphasis that we place in those two 2 determinations.

3 Next slide. So I'm hoping this slide 4 helps partially answer one of your questions that you 5 had about the licensing process and how we look at 6 your applications and how you can submit them. And 7 we'll go into some more detail on this when we get 8 specific with your application.

9 But both the Atomic Energy Act and the 10 regulations allow for an applicant to combine 11 applications. And this is common.

12 There's, and mostly we'll see this with 13 the operating license application. In order for 14 reactors to operate, they will also require a Part 70 15 license in order to possess and use material on their 16 site.

17 And then following that up, the commission 18 does combine those licenses. So you see, and Al will 19 show you an example of that later today.

20 When reactors are issued licenses, there 21 is typically a Part 70 license. And the Part 30 22 license, and sometimes the Part 40 license that are 23 combined together in that, is on a single piece of 24 paper and a single license.

25 So we are --

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29 1 MR. FOWLER: Can I ask a question at this 2 point?

3 MR. LYNCH: Yes.

4 MR. FOWLER: At the executive director 5 meeting, Mirela, I believe you did a, at least you 6 helped me, and I'll use the, I could use inappropriate 7 terms in the regulatory environment because it's not 8 an environment that I deal with every day, but I 9 understood from your presentation, in that meeting, 10 that we had the choice. That we could submit a 11 separate Part 70 license or we could submit, under the 12 Part 50 umbrella, the Part 70 requirements with the 13 important caveat that the Part 70 information, at that 14 point of submission, needed to be final because it was 15 a one-step process.

16 And so I understood our follow up to be 17 within one week of that meeting, to confirm that 18 understanding to us that we had that option, between 19 those two choices. And, so I think in the interest of 20 time, if we could simply confirm that, that our 21 understanding is compatible with your understanding, 22 I think we're all set.

23 MS. GAVRILAS: What I said at the meeting 24 is still what our position is. And we'll walk you 25 through the slides.

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30 1 This just helps explain the details. The 2 bottom line is, we look at your activities from a 3 safety perspective. And the security perspective.

4 So as long as we -- and our rules and our 5 guidance help us know what we need to evaluate in 6 those activities.

7 So whether the description of how you make 8 your safety case comes on one piece of paper or on two 9 pieces of paper, is not that important. In the end 10 we're going give you one license that captures all of 11 those activities.

12 But the review is going to be, we're going 13 to look at every safety component that we need to and 14 every security component of all the activities that 15 you are proposing.

16 So in other words, it doesn't matter how 17 the information comes in, the regulation is designed 18 to allow us to combine that information into one 19 license. And the regulation does allow us to 20 basically eliminate repetition.

21 So if you provided something in one 22 context, you don't need to resubmit that information, 23 because you do get credit for it under the activity.

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31 1 again.

2 MS. HELTON: Mirela, I agree. I just want 3 to make sure that it's clear that the packaging is up 4 to you. How you package it all together, multi 5 submissions, a single submission.

6 What needs to be clear, in your submission 7 or submittals, however you decide to do it is, what 8 regulations you're seeking to comply with. And then 9 you also have to fully demonstrate your compliance 10 with those regulations.

11 So it just has, however you do your 12 packaging, it has to be very clear that if you intend 13 for this information to satisfy Part 70, subpart (h),

14 or whatever you're going to do, that you have to very 15 explicitly.

16 That will help our review greatly if you 17 very explicitly say, this is the information that 18 complies part umptysquat. But, you know, we can't 19 identify that for you, you have to identify what parts 20 of the regulation you need to comply with, and then 21 you have to demonstrate how you comply.

22 MS. GAVRILAS: And to add to what Shana is 23 saying, you can cross reference in all of your 24 document that you submitted.

25 MS. HELTON: Right.

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32 1 MS. GAVRILAS: And right away, that adds 2 to the case that I'm trying to make in this piece of 3 paper.

4 MR. FOWLER: So very simplistically, from 5 my standpoint, again, because I'm not schooled in the 6 art of regulatory review, is the final Part 70 7 information, we can include, either in our operating 8 license under Part 50 application or as a separate 9 Part 70 document, but we need to be clear about what 10 we're submitting under which format.

11 MS. HELTON: Right.

12 MR. FOWLER: So if I have that very high 13 level kind of understanding, that will put it in my 14 brain, Carolyn will take care of the details. But at 15 least now I have it in my brain that the Part 70 is 16 either under an operating license or under a separate 17 Part 70 submission.

18 MR. LYNCH: Yes. And I think what's most 19 important there is, we're looking to make our safety 20 determination based on technical information that you 21 provide.

22 Whether it's Part 50 or Part 70, we still 23 have to say, we have technical requirements that we're 24 trying to make to justify safety. So we're looking 25 for technical information.

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33 1 And when we have all that technical 2 information, we can figure out which box, you know, 3 will it be a full, will it be Part 50 with Part 70 as 4 part of that or separately. But we will evaluate that 5 based on the request that you ask of us.

6 MS. HAAS: We understand the safety 7 aspect. I mean Nick is just trying to bring it up --

8 MR. FOWLER: Yes.

9 MS. HAAS: -- because it's based on 10 conversations we've had over the last two or three 11 years and it got modified within your organization.

12 So we just wanted to make sure that we understood it, 13 and we do. So thank you for the input and we'll move 14 on.

15 MS. GAVRILAS: You know, we start every 16 public meeting with a disclaimer, which is, we're not 17 going to reach regulatory decisions here and there's 18 a reason for that.

19 Everything that the staff reviews needs to 20 be on the docket. I mean that's the tentative of how 21 we operate.

22 So we have dialogue here. So right now, 23 what we have for review in front of us and what we can 24 be very specific on, at least the portions that we've 25 reviewed, is the construction permit. The Part 50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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34 1 construction permit.

2 Anything else is in pre-application space.

3 If that makes sense?

4 So if there is -- if we're sometimes 5 tentative or give you our best opinion, we will 6 clarify. That opinion will become definitive, once we 7 have an application in front of us.

8 It's worth repeating because, again, in 9 the absence of information, all we can do is say what 10 the most likely path is.

11 MR. LYNCH: Okay. Next slide. So what 12 we're going to transition to now is talking a little 13 bit more about the actual review process for the 14 construction permit. And we'll get into timelines and 15 what our expectations are for the review that we have 16 ahead of us.

17 So to introduce this, this is just kind of 18 a high level flow chart to highlight the main pieces 19 of the construction permit review. We have two 20 parallel reviews that we'll be going on.

21 And this is our safety review of your 22 preliminary safety analysis report and the 23 environmental review of your environmental report.

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35 1 to the commission's decision to either grant or deny 2 your request for a permit.

3 The review, the output of that will be the 4 safety evaluation report prepared by the staff. That 5 will be reviewed by the ACRS.

6 And as part of their independent review, 7 it will also be considered by the commission and the 8 mandatory hearing.

9 There's also a possibility that there 10 could be contentions filed as a result of this. And 11 we'll talk a little bit more about that in a few 12 slides, but that's another step that could be in this 13 process.

14 The environmental review will also be, the 15 environmental impact statement that's being prepared, 16 will also be considered by the commission and its 17 decision to grant or deny the construction permit.

18 So right now I'm going to turn the 19 presentation over the Nancy Martinez, the project 20 manager leading the review of your environmental 21 report. And she's going to talk through some of the 22 specifics of the environmental review process and the 23 status of their review.

24 MS. MARTINEZ: Thank you, Steve. As Steve 25 mentioned, I'm the environmental project manager for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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36 1 the application. And I'm going to discuss the 2 environmental review process.

3 The environmental review is going to be 4 performed in accordance with the National 5 Environmental Policy Act of 1969. Commonly known as 6 NEPA.

7 NEPA requires fellow agencies to follow a 8 systematic approach in evaluating the potential 9 environmental impacts of the proposed action and to 10 assess the alternatives to those actions. The NEPA 11 process involves public participation and disclosure.

12 NRC's environmental regulations 13 implementing NEPA are contained in 10 CFR Part 51.

14 Slide 17 please. This slide presents an 15 overview on the steps that lead to the environmental 16 review process.

17 When an application is submitted to the 18 NRC, the NRC conducts an acceptance review. And an 19 acceptance review determines if the application has 20 sufficient information for the staff to conduct its 21 technical review.

22 If the application is accepted, the NRC 23 staff conducts a NEPA document determination. And 24 that is to whether develop and prepare an 25 environmental assessment or an environmental impact NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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37 1 statement.

2 I will discuss in later slides, for the 3 Northwest application, the staff determined to prepare 4 an environmental impact statement. Once the NEPA 5 determination is made, the environmental review 6 process is conducted in accordance with 10 CFR Part 7 51.

8 Slide 18 please. This slide presents an 9 overview for NRC's environmental process.

10 Specifically for the environmental impact statement.

11 The environment review for an EIS begins 12 with the scoping process. Which includes a public 13 meeting.

14 Scoping is a process by which the NRC 15 staff identifies a specific impact and significant 16 issues to be considered in preparation of the 17 environmental impact statement.

18 Following the scoping process, the NRC 19 staff will perform its environmental analysis, which 20 will consist in part, of issuing request for 21 additional information to the applicant and preparing 22 the draft EIS.

23 The draft EIS is issued for public 24 comment. Once comments are received on the draft, the 25 NRC staff will consider those comments and issue its NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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38 1 final environmental impact statement.

2 Slide 19 please. The environmental review 3 for the environmental impact statement will take 18 to 4 22 months. This slide provides a detailed breakdown 5 of the process and timeframes.

6 As I previously mentioned, the 7 environmental review will begin with the scoping 8 process. Which for Northwest consisted of a 45 day 9 scoping period and a public meeting.

10 After the scoping period ends, the staff 11 develops a scoping summary report that addresses 12 public comments that were received during the scoping 13 period. This takes a minimum of 90 days and depends 14 on the number of comments that were received during 15 the scoping period.

16 The environmental analysis, in part, will 17 consist of developing and issuing a request for 18 additional information. Each round of RAIs will take 19 approximately 90 days.

20 And this will consist of developing and 21 issuing the RAIs, a 30 day response period and then 22 the staff reviewing the responses for clarity and 23 adequacy. The number of RAI rounds will depend on the 24 quality of RAI responses and the application.

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39 1 RAI responses, the scoping process, coordination with 2 other federal, state, tribal and local agencies, as 3 well as the staff's independent research, will be used 4 to draft the EIS.

5 When the draft EIS is published, it will 6 be made publically available for review and comment 7 for a 45 day period, in accordance with our 8 regulations. The comment period will include a public 9 meeting.

10 After the draft EIS comment period, the 11 staff will respond to comments provided on the draft 12 EIS and update the EIS as necessary. And this can 13 take approximately 120 to 150 days. And depends on 14 the number of comments and also the necessary EIS 15 updates. The final EIS is then issued.

16 Slide 20 please. The staff will perform 17 its environmental review in accordance with 10 CFR 18 Part 51. And will also use Interim Staff Guidance 19 augmenting NUREG-1537.

20 Slide 21 please. On February 5th, 2015, 21 Northwest resubmitted Part 1 of its construction 22 permit application. The public notice of receipt and 23 availability was issued on April 21st, 2015.

24 The NRC staff conducted an acceptance 25 review of the Northwest environment report, Chapter 19 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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40 1 of the application, in accordance with 10 CFR Part 51, 2 which identifies the information that shall be 3 contained in the applicant's environmental report.

4 An acceptance review is a completance 5 review that determines if the application has 6 sufficient information for the NRC staff to begin its 7 technical review.

8 Part 1 of the Northwest application was 9 accepted and the notice of acceptance was issued on 10 June 8th, 2015.

11 Slide 22. In accordance with 10 CFR 12 51.25, the staff determined whether to prepare an 13 environmental assessment or an environmental impact 14 statement.

15 Pursuant to 10 CFR 51.20(a)(2), the staff 16 determined that an EIS should be developed for the 17 proposed action. This determination was based on 18 operation of the proposed Northwest facility.

19 Connected action to the issuance of a 20 construction permit, consisting of target fabrication 21 and scrap recovery. A process similar to the process 22 used by field fabrication facilities, for which an EIS 23 is required under 10 CFR 51.20(b)(7).

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41 1 and decommissioning of the Northwest facility. We 2 will also consider the impacts of alternatives to the 3 proposed action, including alternative sites, 4 alternative technologies and the impacts of not 5 issuing a construction permit.

6 The environmental impact statement will 7 also consider the impacts from irradiation services 8 provided by the research and test reactors. Which is 9 a connected action to the proposed action.

10 Ultimately, the purpose of the 11 environmental review is to take a detailed hard look 12 at the environmental impacts of the proposed Northwest 13 facility. And after balancing the benefits versus the 14 cost or impacts of the proposed project, make a 15 recommendation to the commission on whether or not to 16 issue a construction permit.

17 Slide 24. The Northwest environmental 18 scoping period ended January 4th, 2016. The staff is 19 currently developing the scoping summary report and 20 responding to comments.

21 Two rounds of RAIs have been issued. The 22 first on November 2nd. Northwest responded to those 23 RAIs on December 3rd. The staff reviewed the 24 responses and had some follow ups. And those RAIs 25 were issued on January 19.

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42 1 NRC anticipates that the draft EIS will be 2 issued on October 2016 and that the final EIS will be 3 issued on May 2017. And this is based on the 4 timeframes in the slide that I have provided earlier.

5 And is keep within the 18 to 22 month schedule.

6 And that concludes my presentation on 7 environmental review.

8 MR. LYNCH: All right, next slide please.

9 For those on the phone, this is Steve Lynch again.

10 And I'm going to talk a little bit about the 11 construction permit safety review process.

12 Briefly touching on the content of the 13 PSAR in a little bit more detail, as well as going 14 through some of the assumptions that we made and 15 coming up with this 18 to 24 month timeline for our 16 review schedule.

17 So as I mentioned, I've mentioned most of 18 this before. The main components of the preliminary 19 safety analysis safety report are the preliminary 20 design of the facility. A preliminary analysis of 21 structure systems and components with an eye towards 22 how those will be used to prevent and mitigate 23 accidents.

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43 1 for the application to identify probable subjects of 2 technical specifications.

3 And again, while emergency plan also is 4 not required, there are some requirements in Appendix 5 E of Part 50, to address a preliminary emergency plan.

6 We'll also be looking at your quality 7 assurance program and any planned research and 8 development that you have.

9 Next slide please. So for the review that 10 we do, so the last slide talked about the regulatory 11 requirements that need to be met. We had developed 12 guidance in order to evaluate whether those 13 requirements have been met.

14 And for your application, the guidance 15 that we are primarily using is NUREG-1537, as 16 augmented by Interim Staff Guidance.

17 And the most applicable part of that, as 18 you used in the development of your application, was 19 the guidance for radio isotope production facilities.

20 And that was largely based on guidance in NUREG-1520 21 that Dave will talk about in a little bit.

22 Other guidance that we used. There are 23 ANSI standards that are referenced in these documents 24 we used for our reviews as well.

25 Next slide please. So getting more into NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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44 1 the process and timeline. After you submit your 2 application, first thing the NRC staff does is review 3 the application to see if we have enough information 4 to accept it for docketing.

5 What goes into this acceptance review is, 6 we look at the request you made for the type of 7 application you are seeking. We see if we have the 8 technical information, the application to support that 9 request to conduct our review.

10 And if we're aligned on the request you're 11 making and we think we can review it under that 12 licensing process, then we make sure that we have all 13 of the information required by the regulations for 14 that process.

15 We're not doing a detailed review at this 16 time, we're looking for completeness of the 17 application. And if we believe that the application 18 is complete and has addressed all of the regulatory 19 requirements necessary for that type of application, 20 we will accept the application and docket it.

21 And once docketed, that indicates the 22 beginning of our formal technical review of your 23 application.

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45 1 evaluation report. Which documents the NRC's findings 2 on the application and our recommendation to the 3 commission on whether we believe the construction 4 should be, permit should be granted or not.

5 In support of development of this safety 6 evaluation report, the staff may find it necessary to 7 request additional information to help us understand 8 the information that's in the application or to 9 provide any additional details we need to make our 10 conclusions.

11 After we complete our safety evaluation 12 report, we will present this report and you will 13 present your PSAR to the ACRS. There will be 14 subcommittee and full committee meetings on this.

15 And the ACRS will provide an independent 16 review of your application and the NRC staffs 17 evaluation and provide a recommendation to the 18 commission on whether they believe the construction 19 permit should be issued.

20 Following this, we do have the potential 21 for a contested hearing. And there will be a 22 mandatory hearing. Where, again, the adequacy of the 23 safety and environmental reviews will be considered.

24 And that will ultimately lead to the decision to grant 25 or deny the construction permit.

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46 1 Next slide please. So I put together a 2 sample 22 month safety review timeline that's based on 3 our previous reviews. And also just kind of a middle 4 ground between that 18 to 24 month time period.

5 And I wanted to highlight just some of 6 what went into that so it doesn't, it isn't a complete 7 mystery of what we're doing while we're reviewing your 8 application.

9 So after docketing your application, 10 within about two months we are, our goal is to begin 11 issuing requests for additional information, if 12 necessary.

13 Our goal is to complete issuing our first 14 round of request for additional information within 15 about a six month time period. So that will take us 16 to, as you see on the screen there, in eight months 17 after the docketing of the application, our goal is to 18 issue all of the requests for additional information 19 that we may have on your application.

20 Typically, when we issue a request for 21 additional information, we will ask for a 30 day 22 response timeframe. If this is not something you 23 believe you can meet, you can talk to your project 24 manager and workout a time period that will work for 25 both of you.

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47 1 So after about nine months, our goal would 2 be to have received responses from you on all of the 3 requests that we have issued. Following that, 4 reviewing the information and providing request for 5 additional information, it may be necessary to ask 6 additional RAIs.

7 So in this timeline we've incorporated the 8 need for a potential second round of requests for 9 additional information. That would require another 10 six months' time period.

11 After all of our requests for additional 12 information have been answered, and the staff is able 13 to complete a safety evaluation report, then we go the 14 ACRS. And right now, in this timeline, we have about 15 19 months after accepting the application for 16 docketing, we would hold our first ACRS subcommittee 17 meeting.

18 Based on our past experiences, with 19 licensing similar applications, we have seen that it 20 will be likely necessary to have multiple ACRS 21 subcommittee meetings.

22 In this timeline we have anticipated there 23 could be two ACRS subcommittee meetings. And these 24 can be held, essentially you would have an 25 opportunity, at most, once a month, while the ACRS is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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48 1 in session, to meet with them to discuss that.

2 Once the ACRS is satisfied, at the 3 subcommittee level, that you have addressed all of 4 their technical concerns with the application, a full 5 committee meeting can be scheduled. And after the 6 full committee meeting, the ACRS would prepare its 7 recommendation to the commission on your application.

8 Following the completion of the ACRS full 9 committee, the staff has been able to finalize its 10 safety evaluation report based on feedback provided by 11 the ACRS. And after that is when we would schedule 12 the hearing.

13 Next slide please.

14 MR. ADAMS: Can I, this is Al Adams, can 15 I -- I just want to emphasize one point on this slide.

16 Although this slide shows 22 months, that you can see 17 the licensing activities are completed on this slide 18 in the first 18 months.

19 So there is time that is devoted to 20 activities, which are beyond the development of the 21 safety analysis. The visits to the ACRS and the 22 mandatary hearing.

23 So although it may seem like a 22 month 24 schedule, the actual licensing work is condensed into 25 the first 18 months of that. Thanks.

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49 1 MR. FOWLER: And what I -- pardon the 2 interject here, but I see, you know, the objective 3 that I have in this meeting are to explore, how do we 4 accelerate schedules.

5 MR. LYNCH: Yes.

6 MR. FOWLER: And I appreciate this 7 outline. There is implicit assumptions about cycles 8 in here.

9 And that's an obvious opportunity to 10 reduce the overall time, if we reduce the number of 11 cycles.

12 MR. LYNCH: Yes.

13 MR. FOWLER: What is less clear to me is, 14 what drives subsequent cycles? Is there a threshold?

15 What's the bar that we, as a company, need 16 to meet to avoid a subsequent cycle and therefore 17 accelerate the schedule? That's what's not so clear 18 to me.

19 MR. LYNCH: So I think that there's a 20 number of things that we can do. And when we ask, 21 what we can do is, when we ask, request for additional 22 information, it's important that you understand the 23 questions that we're asking.

24 You can go to the next slide. Let me 25 answer your question and then we'll go through the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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50 1 slides as well. You can click to the next slide. But 2 it's all related. That's the next topic I was getting 3 to.

4 But when we issued the request for 5 additional information, it's important that after 6 they're sent to you, you have them, read through them, 7 have a phone call with us. If we need to meet, we can 8 do that as well.

9 But we want to make sure that for every 10 question we ask, you clearly understand what we're 11 asking. And if you don't understand, you ask us to 12 clarify.

13 Because it cannot be the best use of 14 either of our times if you don't understand the 15 question we're asking. You answer what you think 16 we're asking, but that's not what we're looking for, 17 then we have to ask the question again.

18 So making sure that we have a clear, 19 mutual understanding of what the information gap is 20 that needs to be filled, that can help.

21 And then as you're preparing your 22 responses, check in with us again and make sure that 23 you still understand and you're going down the right 24 path. And providing complete answers the first time 25 they're asked can also help.

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51 1 So I think one of the keys two reducing 2 the iterations that we have to go through in that RAI 3 process, is making sure that you understand the 4 question that's being asked and providing complete 5 responses to that.

6 MR. FOWLER: So we're learning how to work 7 with each other?

8 MR. LYNCH: Yes.

9 MR. FOWLER: And we've had some 10 experience. And, Nancy, maybe I can put you on the 11 spot here because we've now had two cycles of requests 12 for additional information with the environmental 13 portion of the technical review.

14 How would you characterize the ability for 15 the two organizations to communicate?

16 Is the second cycle driven by a 17 communications challenge or is it driven by, you peel 18 the layers of the onion back and you find something 19 that you didn't see the first time that initiated a 20 second round of questions?

21 So in order to be productive, help us to 22 understand, from the limited experience we have 23 already, how we could do it even better on the next 24 cycle.

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52 1 review RAIs, the second round of those RAIs were 2 driven by follow ups to the first round where the 3 question was not addressed adequately. So we had some 4 follow ups on that.

5 But we also had some follow ups on the 6 responses because information was provided, and then 7 we needed additional information just based on the 8 response. It was really a combination of some of the 9 questions were not answered completely, and then there 10 was responses provided, and then we had follow up to 11 that.

12 We also did, you know, when we issued the 13 RAIs, as Steve mentioned, we did say, let us know if 14 these are clear and if you would like to have a call 15 to discuss them. We did that for both rounds.

16 So we're hoping that that will open that 17 communication channel, as you just said.

18 MS. GAVRILAS: I want to take it a step 19 higher, because this is general. So you mentioned the 20 two cases. Indeed, those are the two instances for 21 which we ask additional RAIs.

22 There's an expectation that the technical 23 reviewers have started to write their safety 24 evaluations and are well along their safety 25 evaluations.

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53 1 So when they ask, when they request 2 additional information, it's designed specifically to 3 augment the piece that they're writing right now. So 4 that means it truly -- they know exactly what they 5 want. Or they have a very clear picture of what they 6 want.

7 I'm not saying that the peel the orange, 8 you know, or onion, whatever you're peeling, doesn't 9 happen, but that's rare. Because of how we do, how 10 the expectation is that when you ask an RAI, you 11 basically know what kind of information you're seeking 12 to document your safety conclusion.

13 So along the lines of dialogue, there's 14 two times that there's opportunity for dialogue when 15 it comes to a request for additional information.

16 One is, when we are drafting the question 17 itself. Right? Because then we want to make sure 18 that we engage with you and make sure that the words 19 that we put on paper, do convey our needs.

20 And then there's a second opportunity to 21 engage in dialogue. Which is, when you've drafted 22 your answer, we have an opportunity to check that 23 indeed your answer answers the mail.

24 That is, in our experience, the most 25 efficient and effective way to deal with responses for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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54 1 additional information.

2 MR. LYNCH: Nicholas?

3 MR. TIKTINSKY: And I'd like to add a 4 little more on that too. A lot of it's nature of the 5 rounds of questions. And this is Dave Tiktinsky.

6 A lot of it is nature of the rounds of 7 questions. So if the questions are, you provided 90 8 percent of the information we want and we need some 9 clarifications of something, then usually it only 10 requires one round.

11 If the questions are more like, you need 12 to develop or give us your methodology that you, how 13 you develop something or you're programing, we need to 14 understand what that is. Once we get that answer, 15 about what your program is or what your methodology 16 is, that may lead us to other questions.

17 So really it's the nature of how the 18 information was in the application, how specific it 19 was. And really the level of what that question is.

20 The specific questions, usually can handle 21 them in one round. The more programmatic, methodology 22 kind of questions frequently require follow ups.

23 MR. ADAMS: And, this is Al Adams, I just 24 want to build on something Mirela said. That that 25 discussion that we have, once you start to develop NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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55 1 your answers, that's not a sort of a verbal review of 2 your answer.

3 I mean, you know, the reviewers have to 4 sit down and carefully consider the answers. What 5 that is looking for, if we're expecting an answer to 6 go in this direction, and when you talk to us, we find 7 out that you're going in a completely different 8 direction.

9 So it's basically to find significant 10 issues before you submit the answers to us. So if you 11 submit the answers to us without having that 12 discussion with us then, you know, then there's just 13 possibility for a misunderstanding or 14 miscommunications in the RAI process. And that can 15 contribute to additional questions.

16 MS. GAVRILAS: And we cannot, this is 17 Mirela again, we cannot emphasize enough how important 18 that dialogue is. Those are the, probably the biggest 19 contributors to our expediting the review.

20 MR. LYNCH: Okay. Actually, so I think 21 we've talked mostly through Slide 30. Let's go to 22 Slide 31, which will continue this conversation we 23 have on impacts to schedule.

24 And this, in addition to RAIs, there is 25 other things that we can do to help ensure that our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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56 1 review is moving along efficiently. And can impact 2 schedule.

3 One is the quality of the application 4 where all the regulatory requirements met. And this 5 is, I'm speaking hypothetically and not in your 6 application.

7 But if we do a review of the application 8 and the regulatory requirement is not met, it could 9 result in the application being rejected and needing 10 to be resubmitted. Or it could result in significant 11 new information that does need to be presented and for 12 review.

13 Technical and completeness. Again, the 14 more information you give us without having to ask for 15 it, the more efficiently we can review the 16 application.

17 And then also just attention to detail.

18 And this has to do with the organization of the 19 application, formatting, looking at proprietary 20 markings. Just those little details that maybe aren't 21 necessarily technical, but can help us in our review.

22 If we don't have to worry about the little things.

23 Then building on our conversation on 24 request for additional information, in addition to the 25 number of rounds we ask, the quicker that you provide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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57 1 responses to us, the quicker we can continue on with 2 our review.

3 So timeliness, responsiveness, 4 completeness of our requests and how you provide 5 answers to them, that can all help facilitate our 6 review.

7 And I think a good point that Dave 8 mentioned was, what can take more time is if in these 9 requests for additional information, significant new 10 information is provided that we have not reviewed 11 before. That can take additional time. And could 12 result in additional requests.

13 MR. ADAMS: Can I -- Al Adams. Can I jump 14 in here?

15 And completeness is probably the most 16 important of those things. If you, you know, we asked 17 for a 30 day response and you come in in 20 days and 18 look, you know, you've come in ten days sooner. But 19 those answers aren't complete and result in another 20 round of RAIs, that round is going to consume a lot 21 more than the ten days that you saved by coming in 22 early.

23 So completeness is the most important, I 24 think, aspect of this. And I think what you're seeing 25 is, you know, the thing that draws out schedules is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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58 1 having to go additional rounds of RAIs.

2 That's the most, you know, our experience 3 has shown us that's the most significant contributor 4 to schedules being drawn out.

5 MR. TIKTINSKY: Another thing I might want 6 to add too is, we're not going to wait till the end to 7 give you all the RAIs at one time. You saw that, the 8 schedule that Steve had shown there.

9 The idea is, when major portions of the 10 review are done, we will ask RAIs that are 11 appropriate. We don't want to be asking you the same 12 technical area a bunch of different times.

13 So when we're done with an area and we 14 feel like we're done with that part of the review and 15 comfortable with that, we'll ask those rounds of 16 questions. But we want to spread it out over that 17 time period, the six month time period that Steve had 18 outlined.

19 It's more efficient that way and it allows 20 your staff to work on it. Also, we don't want to hold 21 somebody up, you know, waiting for another disciplines 22 review to be done.

23 MR. ADAMS: So you may get a second letter 24 from us, but it's actually the first round of RAIs in 25 that area. And there's nothing to be gained by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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59 1 sitting on the RAIs and giving you a hundred questions 2 at once and overwhelming your ability to answer.

3 So when we have an area ready to go, we 4 will send it to you to allow you to spread out your, 5 you know, your limited resources also. And ours too.

6 MS. HELTON: This is Shana Helton. I'd 7 just like to reemphasize that when, especially when 8 you're crossing different portions of the regulations, 9 that the clearer you are in your initial submittal 10 about, this is how we're meeting 70.32, this is how 11 we're meeting 50.20.

12 I mean just the clearer you are in your 13 application, will help us avoid those types of request 14 for additional information where we say, hey, tell us 15 how you're meeting the requirements in here.

16 And then if we're at that sort of basic 17 level of, how are you meeting the regulations when you 18 give us that answer, that's almost guaranteed a second 19 round because now we're going to ask you questions 20 about that.

21 I mean every applicant wants to avoid 22 going multiple rounds of request for additional 23 information. But it's just been our experience that 24 when we have to do those basic sort of questions 25 about, how are you meeting our regulations, that tends NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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60 1 to, once we see the detailed technical information, we 2 tend to then have questions about that.

3 So I can't emphasize enough that initial 4 clarity in your submittal.

5 MS. GAVRILAS: So if I -- I'm sorry.

6 MR. MORRISSEY: No, that's okay.

7 MS. GAVRILAS: More comments on RAIs.

8 Because I want to --

9 MR. MORRISSEY: No, I had just a 10 discussion about the technical reviews. My name, 11 Kevin Morrissey.

12 As having been a technical reviewer for a 13 long time, and actually I was a licensee, is my advice 14 would be, don't be shy about asking the staff what 15 they want.

16 You know, we're talking about all the 17 things we expect from you, you should expect to think 18 the same things and clarity from the staff. You know, 19 lots of time we go, I shouldn't ask this, I shouldn't 20 ask that. Is you really have to dig down sometimes 21 and let your staff talk to our staff and really get 22 down to exactly where you're going.

23 Then you're less likely to end up in the 24 wrong place and wasting your time. So don't be shy.

25 That would be my advice.

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61 1 MS. HELTON: Absolutely. Getting the 2 technical experts to communicate directly so there's 3 an understanding, is a good practice. To have a 4 public meeting on those RAIs.

5 MS. GAVRILAS: So again, it's important to 6 sum up. It's important to distinguish between various 7 increments at the same round, the RAIs and follow up 8 RAIs.

9 The increments are designed to help us 10 all. To move the process along.

11 The follow up required are basically 12 because we needed additional information. And while 13 we can't, those are the ones that we target for, for 14 minimizing. We can't eliminate them completely, but 15 we target for minimal follow up RAIs.

16 I want to go back on Slide 30, Steve, if 17 you can, for just one moment. Because there's --

18 we've talked a lot about RAIs and how you can do, what 19 you can do to basically help us out, speed the process 20 along.

21 But what's important in our timeline is 22 also to recognize that there's a safety reason for how 23 the timeline is developed. There's nothing that's 24 carved in stone, because it's arbitrary.

25 And I'll give you, as an example, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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62 1 writing of the SER. It doesn't help to distribute a 2 chapter in a technical area amongst reviewer. That 3 won't speed up the process. The review has to be 4 comprehensive. The reviewer needs to see everything.

5 If there are chapters that cross over 6 technical expertise, that needs to be seen by 7 everybody. So the timelines that you see that it 8 takes the staff to draft the SER and to come up with 9 RAIs, is also informed by basically what we need to do 10 to come up with a safety finding.

11 And with that, I'll turn it back to where 12 it was.

13 MR. LYNCH: Sure. Back to Slide 31.

14 Again, this is Steve Lynch. Other impacts that, to 15 schedule, could be if there are policy questions that 16 need to be resolved. I can give an example from a 17 past, a past review.

18 In the case with SHINE, we had to go to 19 the commission to resolve how, you know, whether SHINE 20 should be under Part 50 versus Part 70, and we ended 21 up needing to do a rulemaking in order to classify 22 them under Part 50. That can be a potential impact to 23 schedule if that's something that's necessary in our 24 review.

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63 1 schedule, is the number of times we have to go to the 2 ACRS. Limiting the number of subcommittee meetings 3 that we have to have, by addressing the technical 4 concerns with the ACRS, can significantly improve or 5 delay the schedule.

6 MR. ADAMS: Al Adams. I just want to, the 7 ACRS tells us when they've received enough information 8 before they can write the letter they need to write to 9 the commission.

10 So it's something that quality has control 11 over, but we don't run the ACRS and the committee.

12 And they have to do the review and reach the 13 conclusions they need to reach given what they're 14 responsibilities are.

15 MR. LYNCH: Yes. And what we can do to 16 help them is, when they do identify areas that they 17 need additional information, that both the applicant 18 and the NRC staff provide that as quickly as possible.

19 All right, next slide please. So on the 20 previous slide I was mostly addressing the things that 21 both the applicant and the staff can do to impact 22 schedule.

23 This slide is focused on the things that 24 are outside of the staff and the applicants control, 25 to a certain extent. And this gets into the hearing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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64 1 process.

2 And this comes after the ACRS meeting has 3 been held, the staff has completed its environmental 4 impact statement and the staff has completed its 5 safety evaluation report.

6 There will be a mandatory hearing on this 7 application since it is a commercial facility. And as 8 I just mentioned, but there's a lot of things that 9 have to happen before this mandatory hearing can be 10 held.

11 In addition, there is a potential, and we 12 put this out in our notice of opportunity for hearing, 13 members of the public could file a contention on a 14 portion of the application or the activities that are 15 being conducted. Or proposed.

16 And if that happens, those separate 17 hearings would need to be held and those issues 18 resolved before the mandatary hearing could be held.

19 After any hearings that need to be held 20 are held, including the mandatary hearing, then we get 21 the Commission's decision to deny or issue the 22 construction permit. Based on what we've seen for the 23 combined operating license applications, that have 24 followed a similar process to this, we have seen the 25 commission decision come anywhere between two and five NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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65 1 months following the mandatory hearing.

2 So after the hearing happens, there is 3 additional time. And that's not time that the staff 4 can control, that's on the commission's schedule when 5 they make that decision.

6 Next slide please.

7 MR. BALAZIK: Hey, this Mike Balazik. I'd 8 like to provide a quick status update on the NRC's 9 review of Northwest construction printout application.

10 This slide shows the proposed schedule for 11 the review. Steve and others mentioned some items 12 that can drive the schedule, either delay or expedite.

13 As you can see, that NRC is actually 14 reviewing the application. And I just want to assure 15 you that we've allocated the necessary resources and 16 have the technical expertise to review all aspects of 17 the application.

18 As you can see on this schedule, the staff 19 has targeted September of 2017 for completing the 20 safety evaluation report. And then there's a couple 21 of milestones that we can't really put a date next to 22 yet.

23 There's a couple of related activities, 24 not on this schedule, I'd like to mention. One is the 25 license amendment application by Oregon State NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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66 1 University to irradiate three prototype targets. This 2 amendment was issued in January of 2016.

3 And other item I'd like to mention is, for 4 the research reactors that you've proposed to do the 5 irradiations for Northwest, each research reactor 6 would have to submit a license amendment to irradiate 7 the targets commercially.

8 And we've received notice from the 9 University of Missouri that we can expect the license 10 amendment in calendar year 2016. And Oregon State 11 University has also notified the NRC that they plan to 12 submit their license amendment in first quarter 13 calendar year 2017.

14 MR. LYNCH: Okay. While we're on this 15 slide, do you have any questions about our review 16 schedule?

17 I think, and this is mostly based on 18 previous reviews and the sample timeline that we 19 developed. Do you have any questions on where we're 20 going?

21 MR. FOWLER: Well, I have an observation.

22 And I appreciate this information. And I was somewhat 23 familiar with reading it.

24 And again, I'm looking to explore how we 25 can work together, while maintaining arms' length.

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67 1 Obviously you have an ombudsman role and a review role 2 that is independent and so forth.

3 But I view this as a very critical public 4 health need. And I know everyone recognizes that, but 5 our sponsors and investors are major healthcare 6 institutions servicing tens of millions of Americans.

7 They see this as a real issue that we do work 8 together.

9 They are not for profit organizations.

10 They have a service mission to the American public.

11 And they extend that service mission through us. To 12 provide this.

13 And they're expectation is that we work 14 collaboratively and creatively to not compromise 15 health or safety, but figure out ways where we can 16 reduce the number of RAIs.

17 How can the NRC better set our 18 expectations of what will minimize those rounds of 19 RAIs?

20 How can we work together to ensure that 21 the ACRS review is done in a single pass, rather than 22 two or three passes?

23 What do we need to do together?

24 And if we drop the ball, it's on us.

25 Absolutely it's on us, if we drop the ball.

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68 1 But if we know what the threshold is that 2 we're trying to reach, we will work our darndest to 3 get there. And that's what we're looking for. Is, 4 how do reduce the number of RAIs?

5 How do we, as much as we can, ensure that 6 there aren't multiple rounds through the ACRS?

7 Because if we reduce those number of 8 rounds and if we reduce the assumed number of RAIs, we 9 get a critical isotope to public much more quickly 10 than is even on this schedule. Or we, by insurers, 11 that this schedule is met and doesn't slip.

12 And that's the exploration that I'm very 13 keen on hosting. Because I think we have an 14 understanding of the process. Now how do we work 15 within that process, to have the most expedited 16 schedule possible?

17 MR. LYNCH: Okay. So I think, just at a 18 high level -- so where we're at right now, we're in 19 this February 2016 timeframe. We're anticipating 20 getting out our first request for additional 21 information on the safety review side. And I believe 22 we're on target for that.

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69 1 come up sooner.

2 I think the best chance we have of working 3 towards that goal together, would be once those 4 requests for additional information are issued, just 5 like we discussed earlier, let's get a call setup as 6 quickly as possible so that we can discuss and make 7 sure you understand what we're asking. And --

8 MR. FOWLER: So to that point, Steve.

9 MR. LYNCH: Yes.

10 MR. FOWLER: You have insight by the 11 technical reviewers when an RAI is going to be issued.

12 So rather than wait until it's issued, for us to 13 request a public meeting to follow up and then have 14 the mandatary noticing period and so forth, why don't 15 we automatically schedule a public meeting within 16 certain number of days of the RAI insight issuance, so 17 they don't have to wait longer?

18 MR. LYNCH: There are different ways that 19 we can do this. Yes.

20 And there have -- and the NRC can, you 21 could set up a standing public meeting once a month or 22 once every two months. You know, something like that.

23 That could definitely happen so it's noticed and it's 24 already setup. That can be done.

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70 1 discussion you would like to have on the RAIs. The 2 public meetings are more necessary if we need to have 3 detailed technical discussions about the RAIs.

4 If you would like to have a call, just 5 strictly on, do you understand this, yes or no, could 6 you explain to me at a high level if I'm not 7 understanding what it is, that does not necessarily 8 need to be a public meeting. That could be a phone 9 call between you and your project manager.

10 Or you and with appropriate technical 11 staff. Those could be very quick calls. If it's just 12 for understanding.

13 So it kind of depends on what we need. So 14 that can buy some time too. If it doesn't need to be 15 a public meeting, that can be done much more quickly.

16 MS. HAASS: Well, and that's why there was 17 the request, when we were at the EDO, was to go get 18 that standing meeting done every week, very short and 19 sweet, to say, okay, do we understand this. And then 20 we move on.

21 And so I'm glad that that got instituted 22 or executed that we're now doing that. And that has 23 helped.

24 MS. HELTON: I think when you talk about 25 the frequency, the right frequency for the standing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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71 1 public meetings, and they haven't been established 2 yet, but we certainly can do that. And we've got 3 other examples working applicants where we've met on 4 a biweekly basis.

5 So in terms, I wanted to chat and, I'm 6 sorry, this Shana Helton, about this question on 7 threshold. And what's the regulatory threshold that 8 you have to meet, as the applicant, to operate this 9 facility.

10 So the regulations, we went over the 11 NUREGs as they've been supplemented by the Interim 12 Staff Guidance. That is what we have set as the 13 threshold, if you will.

14 And each applicant is going to meet those 15 regulations in unique ways. With that said, you know, 16 we operated in a public manner. Everything is on the 17 docket.

18 We've alluded to similar reviews in terms 19 of looking at reducing the number of RAIs. I think it 20 would be helpful for you to do some research in ADAMS 21 for what similar designs, the types of requests for 22 additional information that we have had, and the types 23 of responses that have satisfied those additional 24 requests for information. And that should really help 25 to identify the threshold.

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72 1 I mean that said, each application is 2 different, we review it on its merits. We're going to 3 have to take into consideration the unique factors.

4 But that can at least give you a sense of the way we 5 think when we're going through these regulatory 6 reviews.

7 MR. LYNCH: Absolutely. I think that's a 8 very good point. And even more detailed in that, if 9 you really want to see, if you open up the safety 10 evaluation reports we write, especially those -- you 11 can look, for a good example, we just finished our 12 safety evaluation report for the SHINE review. And 13 using the same guidance that you used.

14 The guidance sets the threshold of the, at 15 the end of that, the NRC is explicit and the 16 conclusions that we are trying to make in each section 17 and each chapter that's provided. And there are 18 bullet points there.

19 And once our reviewers are doing the 20 reviews, they're looking at the bullet point, you 21 know, for the acceptance criteria. Was this 22 information provided. And then there's another bullet 23 point, can we draw this following conclusion from that 24 information.

25 So when we're looking at your application, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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73 1 we're trying to answer those questions. If we can't 2 answer a question affirmatively, that's one of the 3 times we'll go to you for a request for additional 4 information.

5 Also, as you'll realize for a construction 6 permit, you may not have all of the information that 7 you would submit at the operating license stage. What 8 can also help the reviews is an explanation of the 9 information that you don't have right now, because 10 your design isn't compete, explaining why it's not 11 ready right now, but also acknowledging that you 12 recognize it is something necessary for the final 13 design.

14 The more, again, it comes back to the 15 completeness. The more information that you can 16 provide us, addressing the information that we're 17 looking for in the guidance, the quicker we can get 18 through the review.

19 And also we are kind of, since we're using 20 our guidance, NUREG-1537 and the ISG, that's kind of 21 the format that we're looking for. You can submit 22 your application in whatever form that suits you.

23 However, if you can expedite the review, 24 it does make it easier if it's generally aligned with 25 the guidance that we're using to go through with. So NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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74 1 that's some other insight.

2 MR. TIKTINSKY: If I could add some more 3 on the RAI meetings? You're right. We don't just 4 wait until they're all done and then make a phone call 5 to you. We know when they're coming, we know when the 6 reviews are done because we, as project managers, we 7 work internally with our reviewers to try and make 8 sure we're asking questions that are clear, that have 9 appropriate regulatory basis.

10 So we're working internally. So we know 11 pretty, some time in advance, before we're getting 12 ready to formally issue the rounds of RAIs. And we've 13 had a lot of experience doing that. And having 14 setting up meetings.

15 And just for your information, you know, 16 parts of the information, like within the ISA, there's 17 other categories, besides proprietary information.

18 There's security related information.

19 So the public meetings that we have, we 20 try and talk as much as we can in publically available 21 information. But there may be some portions of the 22 meetings that are closed. Not only for proprietary, 23 but for security related information and other 24 discussions.

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75 1 in RAI, we try as best as we can to make the RAIs 2 themselves publically available. So that information 3 is out there.

4 Your answers may or may not be publically 5 available, but like I said, we've had a lot of 6 experience in other reviews of making sure we have 7 those conversations.

8 I'd also like to emphasize the point too 9 is, depending upon the nature of the answers, we do 10 the same thing. Have the same kind of meetings when 11 you submit answers.

12 So before you formally submit something to 13 us, it may be a call or you may have a meeting too.

14 If you have substantial discussions about something to 15 make sure that you're really are hitting the mark.

16 Again, we don't do reviews on the fly, but 17 you can get a pretty good sense that, yes, if you're 18 on the right track or not. And that would minimize 19 any problems.

20 But yes, we do plan things out. We try 21 and coordinate that carefully with the reviewers. And 22 we know where the status of things are.

23 And again, that's why I mentioned before, 24 we're not going to just consolidate a bunch of 25 different disciplines and do it at one time, we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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76 1 going to try to phase this through, review it and try 2 to make it as efficient as we can.

3 MR. ADAMS: And this is Al. I'll just add 4 two things. One is, NUREG-1537 is a guidance 5 document, but it is an important document in that it's 6 a format content guide and the staff standard review 7 plan.

8 What we expect for RAIs is that the RAI 9 will start by saying, either here's a regulatory 10 requirement or here's something that the standard 11 review plan is looking for, here's where your 12 application, the information in your application seems 13 to say something different or doesn't seem to have 14 this information. And then the question will come.

15 So, you know, NUREG-1537 is your friend 16 for understanding what we're looking for.

17 The other thing, you talked about the ACRS 18 for similar application to yours. There are 19 transcripts of the ACRS meetings. You can go read 20 those transcripts and see what areas interest the 21 ACRS, what areas they focused on, where they asked 22 both us and the applicant questions and issues that 23 became, you know, issues that were sort of follow-on 24 issues.

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77 1 second in the queue that there is information that's 2 available to you. And that's an important source of 3 understanding how the ACRS works, what they think, 4 what they look at, what they consider important.

5 MS. HELTON: Also publically, this is 6 Shana Helton again, also publically available on the 7 advisory committee is their charter. You know, I 8 encourage you to look at that. They're mandated by 9 statute. They're an advisory buddy to the commission.

10 The staff does not have much influence 11 over how they operate with their schedule. The 12 members need whatever information they need before 13 they'll go to a committee and write a letter.

14 So while we can attempt to work with the 15 ACRS and, you know, it's very difficult to try to 16 manage that schedule. They've got competing demands 17 and they only get together once a month. There are 18 certain months of the year that they typically do not 19 meet. So it tends to be fair.

20 You know, you see an August meeting up 21 there, I don't think they usually meet in August.

22 Sometimes they make --

23 MR. LYNCH: Subcommittee does, full 24 committee does not.

25 MS. HELTON: Full committee does not. So NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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78 1 I'm just saying, there is some limitations in working 2 with the ACRS. They have a statutory role to fulfill 3 and they take it very seriously.

4 So looking at those old transcripts can 5 help try to predict what, as they're membership 6 changes, you know, it's just, it's a variable that's 7 well out of the staff's hands. That's all I can say.

8 MS. GAVRILAS: This is Mirela Gavrilas.

9 And we have, the staff has experienced working with 10 the ACRS. The staff knows the ACRS' schedule.

11 The ACRS itself, from our previous 12 experience, the ACRS too recognizes the importance of 13 this activity. Of establishing a reliable, domestic 14 supply of molybdenum-99.

15 So while there are challenges, they will 16 work with us. We know how to work with them. And 17 past experience says we've been successful to make 18 that as effective of interaction as possible.

19 MS. HELTON: Absolutely.

20 MR. BALAZIK: This is Mike Balazik. I 21 guess I just have one question. We've been, for the 22 environmental review, we've been through two rounds of 23 RAIs.

24 We have been sharing those in draft form.

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79 1 can do on these?

2 I mean, I guess I'm just kind of asking, 3 what can we do differently? We've been through two 4 rounds to help Northwest with the understanding of the 5 RAIs. I guess it's just a question that --

6 MS. HAASS: Yes, I don't think there's a 7 disagreement of we don't understand the RAIs. There 8 were actually, you know, we had a public meeting, you 9 know, when we did the site visit, there was some 10 agreement that the RAIs were complete. You did come 11 back and then say you wanted some additional 12 information.

13 Then there were quite a few additional 14 ones in the second round as well. And it was based 15 upon some additional information you asked for.

16 And so I do think it's complete. And it's 17 sitting here for you.

18 MR. BALAZIK: But it, this is Mike Balazik 19 --

20 MS. HAASS: Now, there really isn't 21 anything else we can do accept keep communicating.

22 But remember, it wasn't until the EDO meeting, until 23 we requested that we have these weekly meetings here, 24 I'm sure that there was an understanding.

25 MR. BALAZIK: This is Mike Balazik again.

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80 1 There's a difference between the weekly status call, 2 which is just overall --

3 MS. HAASS: I know the staff, knowing what 4 we had and where there is a question and how we would 5 go about resolving that. And it could be a public 6 meeting or it could be just, you know, there was a 7 misunderstanding and it was just a quick, you know, we 8 understood it.

9 MR. FOWLER: So I see three areas that 10 offer opportunities to explore expediting. The first 11 I'll call administrative in nature. And those are the 12 mandatory noticing periods, the number of meetings and 13 so forth.

14 The better we can be in advance of 15 understanding when those need to happen, we can 16 eliminate more time that's simply waiting for one of 17 these periods. Or waiting to have a meeting.

18 That's probably the most frustrating to me 19 is having to wait for things. I never want either 20 team to be in a position of waiting for things.

21 Because that, by definition, is lost time in the 22 schedule. So I call that administrative.

23 Then there's this area of technical. And 24 what I'm -- I've heard the term, completeness used 25 sufficiently that it will be lodged in my memory.

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81 1 And so -- and that comes through dialogue.

2 In order to meet this threshold of completeness, the 3 technical teams need to be in communication so there's 4 no misunderstanding of what completeness is required.

5 And I want to test to see we have the 6 appropriate communications mechanisms in place, to be 7 sure we're meeting the completeness guidance.

8 Then there's the regulatory or precedent 9 guidance. Which comes to what I've termed threshold.

10 What threshold do we need to meet.

11 And that's really on us. We've got to do, 12 and have been doing and will continue to do, research 13 into threshold regulatory.

14 So those are the three areas. Obviously 15 the last one is something that we have to work on 16 independently.

17 The other two I believe are areas to 18 explore whether we've done everything together that we 19 possibly can do to meet and better the schedule.

20 And I'm sorry, Mirela, you were going to 21 make a comment.

22 MS. GAVRILAS: Wow, that was, I'm taking 23 notes furiously because I want to answer to, to answer 24 a couple of things.

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82 1 meetings are concerned, that's our practice. So I'm 2 not sure when we implemented it, but I know that we 3 had the same --

4 MR. LYNCH: We talked about it in 5 November. Or no, actually August, at the National 6 Academy of Science --

7 MS. HAASS: It just didn't get implemented 8 until about a month ago.

9 MS. GAVRILAS: Okay. But that is part of 10 our practice. To have those status meetings. But 11 their status meetings do not touch on anything that 12 Nick just mentioned.

13 Okay. So as far as communication, that's 14 what I was writing. The regulatory guidance is the 15 first place to look to see what the yardstick is for 16 completeness.

17 Our discussions, discussions with the 18 staff are intended to augment that. Not replace that.

19 So they come in addition.

20 And sometimes there's no additional needs 21 for communication. Sometimes there are needs for 22 communication.

23 So we need to work together. As soon as 24 you identify a need for further discussion, you need 25 to let us know. And we'll do our part in anticipating NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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83 1 when it's likely that you will have additional 2 requests.

3 Because, for example, if we know that 4 we're asking a broad reaching RAI, like Dave just 5 mentioned. If we're asking you something, what was 6 your methodology, then we can see how that would 7 require an interaction in the public to discuss 8 further.

9 So it's both sides. We both need to be 10 aware. And I think we can both, at least we can 11 committee to our part, to have that awareness and try 12 to be proactive.

13 MR. BALAZIK: Yes. And this Mike Balazik.

14 And the whole idea of the status call, the weekly 15 status call, that was to be implemented as when we 16 accepted the application.

17 I didn't see it, weekly calls, before 18 that, until we got to that point of acceptance of the 19 application. So that was --

20 MS. HAASS: And that was a little 21 different understanding. But no, I'm just glad it's 22 done.

23 MR. BALAZIK: Okay.

24 MR. LYNCH: So, just to finish up with 25 this slide, did we help with understanding ways that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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84 1 we might be able to help accelerate the schedule in 2 terms of strategy? Any other questions do you have on 3 that right now?

4 MR. FOWLER: I think I have a good 5 understanding of the areas that I tried to summarize.

6 MR. LYNCH: Okay.

7 MR. FOWLER: And what I would like to see 8 and what I would ask of our team is, okay, now 9 translate those areas into a plan. What are the 10 processes and procedures that we've put in place, what 11 are the accountabilities, what are the milestones, 12 what in fact are the definitions of success or lack 13 thereof so we know we're on plan or off plan.

14 It's all about project management, once we 15 understand what the plan it.

16 MR. LYNCH: Okay.

17 MR. BALAZIK: All right, this is Mike 18 Balazik, I'll continue on. We want to go through 19 docketing. Steve mentioned earlier what docketing 20 was. And I just wanted to go through the timeframe 21 for docketing of the Northwest application.

22 First I'll start with the Part 1.

23 Northwest submitted Part 1 of its application three 24 times. Once in October 15th, another time, 29th, and 25 November 7th of 2014. This was before providing the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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85 1 NRC with a version that was acceptable for processing 2 and conducting an acceptance review on February 5th.

3 The NRC issued a letter to Northwest on 4 January 23rd notifying Northwest its application was 5 incomplete and unacceptable for docketing. Northwest 6 was allowed 30 days to supplement that application.

7 And Northwest chose to withdraw the application and 8 resubmit. And that was the February 5th, 2015 date.

9 The reason for some of the delays was 10 inappropriate markings of proprietary information.

11 Also, ADAMS had rejected the document due to numbering 12 of pages.

13 When they see a document has so many pages 14 and it doesn't match up, they'll reject the document 15 and try and get it resolved.

16 So Part 1 of Northwest's applications 17 accepted for docketing in June of 2015. And that was 18 approximately two months after successfully processing 19 it into ADAMS.

20 And just real quick on Part 2. They 21 submitted the application, Northwest submitted the 22 application, on July 20th, 2015. However, due to 23 formatting and improper proprietary markings, the 24 application was not fully put into ADAMS until 25 September 18th.

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86 1 The staff completed its acceptance review 2 in the mid to late November 2015. And before 3 notifying Northwest on its acceptance decision, the 4 staff held a public meeting in late November. And 5 provided Northwest an opportunity to clarify its 6 requested licensing action.

7 Following the public meeting, the letter 8 of acceptance was issued in December of 2015.

9 One thing I would like to add is that 10 Northwest submitted large portions of its applications 11 in hard copy form, which lead to delays in processing.

12 In ADAMS, when you submit 1,600 pages, it takes awhile 13 for them to process that.

14 Going forward, submission using the 15 electronic information exchange may reduce those 16 delays. I know that, Carolyn, you've expressed some 17 difficulties using that system, but I can provide you 18 a contact that can help you provide documents in that 19 form. So just --

20 MS. HAASS: So is, I'll put it this way.

21 If you begin to do that, you have restrictions and 22 limitations. Because it is a very archaic system.

23 And because of that, the granularity of 24 graphics and pictures would not be coming out 25 appropriately. And it just absolutely made no sense.

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87 1 And we had a lot of difficulty with your 2 system that we would have two different files, exactly 3 the same thing, one would be accepted and one 4 wouldn't. And we couldn't figure out why.

5 And it was taking too much of our time.

6 That's why you saw the first part tried to be 7 submitted twice. Because we couldn't get it through 8 the electronic system.

9 You have a graphic capability of 300dpi.

10 Our logo is more than 300dpi. And it's on every page.

11 It just isn't worth our time.

12 MR. LYNCH: I believe the 300dpi is a 13 minimum, not a maximum.

14 MS. HAASS: No, it's maximum. I mean 15 there's some real difficulties. And we have a premier 16 person who does our documents, and I'm going to tell 17 you, it is one of the more difficult systems that 18 we've ever had to use.

19 MS. GAVRILAS: So --

20 MS. HAASS: You know, I don't want to take 21 this meeting over with that, and we can discuss it 22 later, but --

23 MR. FOWLER: This is an area, so fully 24 understand the dates. We're well aware of the dates.

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88 1 the difficulties differently from the way the NRC 2 characterizes the difficulties of receipt.

3 I think we can summarize this, that this 4 is an area that is, we should better understand 5 whether this can be improved. Because we sit here 6 today with another stack of paper, to respond to RAIs, 7 because of my teams perceived inability to work with 8 the electronic submission system. That's a problem.

9 Now it could be us, it could be the 10 system. But let's take it off and figure out how to 11 fix that.

12 MS. GAVRILAS: Just a point of 13 information. Quick one. The system is designed the 14 way it is because the intent of the system was to 15 enhance transparency. So that the documents can be 16 viewed on the processors that were prevalent at the 17 time at which it was deployed.

18 MS. HAASS: Right. And that was the 19 issue.

20 MS. GAVRILAS: So it was an optimized --

21 MS. HAASS: Right.

22 MS. GAVRILAS: -- optimized two aspects of 23 our mission. One is, openness, reached the broadest 24 set of stakeholders. And the other one is, making it 25 easier for our stakeholders, for another set of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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89 1 stakeholders, the applicants and licensees to use.

2 MS. HAASS: Right. I mean it is a catch-3 22, but we also had to get to a point where we did it 4 the easiest for us because it would, you know, if you 5 have to take every graphic out and do everything 6 individually and save it individually, it becomes so 7 cumbersome that you will make more mistakes.

8 So we can look into it, you've heard my 9 comments on your system, and there's lots of room for 10 improvement on that side as well.

11 MS. GAVRILAS: Noted.

12 MS. YOUNG: Well perhaps we can get them 13 in touch with or possibly with somebody can stop in 14 today and just give a general explanation of the 15 electronic filing.

16 MS. HAASS: We --

17 MS. YOUNG: Because my understanding is, 18 not only do people submit by transmitting 19 electronically, but they also put information on the 20 CDs. But if the CD files meet the format, it can be 21 easily put in.

22 And applications like --

23 MS. HAASS: We do put a --

24 (Simultaneously speaking) 25 MS. YOUNG: -- requirement.

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90 1 MS. HAASS: We've tried the CD submission.

2 But, you know, we have talked with them. We can do 3 that more in the future.

4 MS. YOUNG: Because I know you're 5 interested in saving time. And any unnecessary --

6 MS. HAASS: Yes, but we're not going to 7 solve either problem today.

8 MR. BALAZIK: I think this is a good spot 9 to take a quick break. Next we'll go into Part 70.

10 So ten, 15. Let's take a 15 minute break 11 and start at 10:30. All right, we're going to go mute 12 on the phone and we'll be back at 10:30. All right, 13 thank you.

14 (Whereupon, the above-entitled matter went 15 off the record at 10:14 a.m. and resumed at 10:33 16 a.m.)

17 MR. BALAZIK: Good morning. This is Mike 18 Balazik again and we are going to resume the public 19 meeting.

20 Right now we are on Slide 36, the NRC 21 Licensing Process. This is, we're going to be 22 discussing Part 70 and I'll turn it over to Dave 23 Tiktinsky.

24 MR. TIKTINSKY: Okay. Thanks, Mike. I'll 25 kind of make a point, my presentation is generally NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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91 1 more, you know, general Part 70, but I have a couple 2 of things that came up from this morning's discussion 3 that maybe will help sort of set the frame.

4 Some of it is some of the keys to 5 effectively, at least on the Part 70-type things, is 6 making sure there is a good understanding of 7 applicable regulatory requirements.

8 So we talked a lot about RAIs, that's sort 9 of the finer thing after you submit something, but in 10 the case of Part 70 is making sure you understand the 11 requirements and if you, you know, if you understand 12 them then obviously when you submit an application 13 related to those things you'll be able to, you know, 14 hit the mark better.

15 And, of course, if there are any specific 16 questions related to applicability of specific 17 sections of Part 70, how it gets implemented, then, 18 you know, the form of pre-application, public meetings 19 that we've had on other things for the Part 50 part, 20 you know, may be appropriate.

21 So that's some other ways of making sure, 22 you know -- You know, a lot of the discussion was, you 23 know, you give us a quality application, well in the 24 CP you have already given us an application, so 25 whether, you know, maybe you would have done something NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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92 1 different in the future, it doesn't really matter now 2 if that's already there.

3 For other future applications you can take 4 a lot more of that into account of the experiences 5 that you'll have with the CP as well as the other 6 experiences that we talked about for other facilities 7 to try and make sure, you know -- You know, the best 8 way to minimize, you know, RAIs is to hit the mark as 9 much as you can.

10 So just sort of to get started on Slide 11 37, just a little bit about Part 70 requirements. You 12 know, Part 70 is relatively brought up if you have 13 broad regulation to cover a whole bunch of different 14 things and it talks about, you know, establishing 15 procedures for issuance of licenses, you know, to 16 title to own, acquire, deliver, receive, possess, use, 17 and transfer.

18 So that's a quite a lot of different that 19 it covers. There is a lot of activities that are in 20 there related to, you know, possession and use. There 21 is the scrap recovery and licensing a fuel cycle 22 facility.

23 So that's, it's a -- Again, it's a fairly 24 broad regulation to cover a lot of types of facilities 25 and activities for special nuclear material.

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93 1 The next slide, Slide 38. It's a good 2 example here of, you know, kind of in parallel to what 3 Steve talked about in Part 50, and these, again, not 4 to, tend to be comprehensive, you know.

5 The regulations in 70.21 what the 6 application should be, how to file it, that, again, 7 emphasize the fact that you can incorporate 8 information by reference.

9 So if there is information that you 10 already provided for your other parts of the facility 11 you don't need to repeat them, you can just reference 12 them.

13 Again, the clarity of those references 14 helps the reviewers a lot, you know, the use of 15 crosswalks, tools, you know, whatever is efficient.

16 We want to make sure that the reviewers 17 know where the information is, know how to find it, 18 find it quickly, you know, and shows how it meets 19 those particular regulatory requirements.

20 It also has allowance to, if in Part 70 in 21 70.21(b) that you can have other licensed activities 22 specified in regulation, as long as the specified 23 regulations are met.

24 So, again, it's the combining of 25 applications and licenses. It's not just in 50, it's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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94 1 in 70, it's in other parts, so you are allowed to do 2 that.

3 Again, the biggest emphasis that I will 4 have on that is regardless of the form that it turns 5 out you need to be able to demonstrate that the 6 regulatory requirements are met and the clearer that 7 is demonstrated the easier it is to get through the 8 review process and then timeliness for that.

9 70.22, the content of applications, there 10 is various requirements in there. 70.23 talks about 11 approval, so, you know, 70 is a little different than 12 50, the requirements are somewhat different, the 13 findings are different, but they are sort of still in 14 parallel to the, you know, public health and safety.

15 So it's the same theme even if some of the 16 details are different. I think related to criticality 17 accidents, for example, you know, criticality 18 monitoring systems and the applicability of, you know, 19 subpart (h) which has additional requirements for 20 certain types of licenses authorized to possess 21 critical mass and material.

22 The next slide, Slide 39. So NUREG-1520, 23 which is the standard review plan that we use for a 24 fuel cycle facility license application, the first 25 thing to think about is the information that's in 1520 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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95 1 shouldn't be, you know, that much different than what 2 you've seen in 1537, the augmented ISG, because a lot 3 of that was taken from 1520 and some of it just copied 4 for the applicable portion so a lot of it is the same 5 types of methodologies that you would use for the Part 6 70 application under 1520 or already in 1537.

7 So it's not like you would have to 8 demonstrate using different approaches for Part 70, 9 it's the same approaches and then -- or 1520. Again, 10 the regulatory findings that are discussed in 1520 11 talk about Part 70 regulatory findings.

12 The regulatory findings in 1537 talk about 13 the regulatory findings for Part 50. So that's sort 14 of where the difference the staff in its review of 15 Part 70 applications has to make Part 70 findings for, 16 so it's sort of, you know, tailored to the specific 17 regulation.

18 The document, you know, provides guidance 19 to the reviewers, perform safety environmental 20 reviews. Again, you are not required to follow what's 21 in there, you can propose alternatives with 22 justifications, certainly perfectly acceptable.

23 Things that are usually smooth, if you're 24 trying to go, you know, veer a lot from what's in 25 there and you have to prove it, and your case may be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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96 1 difficult, it may take more time.

2 Again, it's not a definite on that. It 3 is, again, depending upon what it is and what is your 4 approach and what's appropriate for your particular 5 facility.

6 Following formats that match something 7 that we recognize are easier. Again, the easier we 8 have to track the information that we need, the easier 9 the review goes.

10 It also provides guidance for various 11 things, you know, new facilities, amendment renewals, 12 a lot of different activities, but the activities are 13 similar to the things that you are doing under, in 14 Northwest.

15 So it's not a foreign -- 1520 relates very 16 directly to the kinds of things that you are doing 17 that would be in your application, so a lot of it is 18 applicable.

19 It also makes references to other NRC 20 guidance documents, some of them like 1513, which 21 relates to the ISA, Integrated Safety Analysis 22 Guidance, which, again, what's in 1537 refers to the 23 same to documents, so, again, it's not a foreign 24 concept of what it is referring to.

25 The next slide, Slide 40. So sort of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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97 1 purpose of, you know, why we even have an SRP it's, 2 you know, if you have a, it's across the board for 3 quality uniformity of review.

4 We want -- It's guidance for the staff of 5 what they should be looking for and how it should be 6 looked across various facilities so we treat everybody 7 the same regardless of what type of facility it is.

8 At least in uniformity the review would be 9 the same even if the information may be different 10 based on specific requirements in the regulations for 11 a specific type of facility.

12 Again, it's the guidance related, it's 13 meeting the underlying objectives and the regulatory 14 requirements, so there is more information in there.

15 Again, if you look at the regulation it talks about 16 the kinds of things you have to do.

17 The idea of having the SRP is to give more 18 guidance and details of some of the kinds of 19 methodologies and approaches that the staff would find 20 acceptable.

21 As I mention this flexibility, you don't 22 have to follow it, but you have to, you can provide 23 alternatives and also address it as, you know, Part 24 20, Standards of Radiation Protection, and Part 70.

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98 1 different than Part 50 is, you know, the chemical-2 related hazards that are considered in Part 70 based 3 on the nature of the activities that are done under 4 Part 70 facilities.

5 Next slide, Slide 41. So the guidance 6 that we have in the regulations of 70.31 for issuing 7 a license, so once we determine that all the 8 applicable regulatory requirements are met we can 9 issue a license in the form and then you will have 10 conditions as appropriate.

11 You know, conditions, for example, may 12 relate to, you know, you have to A, B, and C before 13 you can have material. There may be other things.

14 Again, as we do the review and we see where you are 15 there may be specific requirements of things that we 16 would put in in the license conditions.

17 We have done this for other facilities.

18 Again, it's not different than any other fuel cycle 19 facility. If you look at other fuel cycle facility 20 licenses you will a series of some standard conditions 21 and then other ones that are specific to that 22 facility.

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99 1 that you find in there.

2 So then we would -- Again, if it was one 3 piece of paper you would still find the same technical 4 conditions, license conditions in that piece of paper.

5 Next slide, Slide 42. So, you know, how 6 does the applicant demonstrate, and let's say that the 7 regulatory requirements are met, we talked a little 8 bit earlier about, you know, how you do that. So you 9 can, you have a choice.

10 You can combine it with the Part 50, 11 Production Facility Applications, in the case it could 12 be the OL. Again, where it's not specific of exactly 13 when you would submit that document you could do it as 14 a standalone document. Again, you choice.

15 The key thing, again, I'd like to emphasis 16 is you have to demonstrate the regulatory requirements 17 are met and if you are going to use multiple 18 applications in different places then, you know, the 19 easier you make it for the staff to know where those 20 requirements are found the easier the review will go.

21 MS. HAASS: Will you be doing a separate 22 safety evaluation report from 70 to 50 even if it was 23 combined, if it's separate you would do them 24 separately, if it was combined would there be one?

25 How would that work within the NRC?

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100 1 MR. TIKTINSKY: Well part of it is, and 2 exactly where and how many documents sort of depends 3 upon how you submitted it to us, but we --

4 MS. HAASS: But it was combined?

5 MR. TIKTINSKY: We would have to make, our 6 SER would have to make combined regulatory findings if 7 we were making the regulatory findings on the Part 50 8 side.

9 MS. HAASS: Okay.

10 MR. TIKTINSKY: We would have conclusions 11 for the Part 50 part. We would have to make 12 regulatory conclusions in the same document for the 13 Part 70 part.

14 So we would have to make sure we had them 15 all in there, that they were comprehensive. So just 16 like you would need to demonstrate that you met all 17 the applicable regulatory requirements, our SER would 18 talk about the staff's acceptance, the reasonable 19 assurance, for all those regulatory requirements.

20 MR. FOWLER: More pertinent to the 21 previous conversation is does one pathway offer an 22 easier, faster schedule than the other pathway?

23 MR. TIKTINSKY: It's hard to say in terms 24 of the speed. Clearly, the easier you can make it on 25 us to understand what you are doing and, you know, not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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101 1 -- Again, I should say, if there is a long time period 2 between submittals of one and the other then, you 3 know, tech reviewers that reviewed one part have to go 4 back and look at it to make sure they have covered it.

5 So there is some efficiencies in having 6 the same people looking at both aspects at the same 7 time. So I know about that --

8 MS. HELTON: If we go ahead a couple of 9 slides I think we're going to get to that, too, but 10 Dave is also going to talk about the differences 11 between the 2-step Part 50 license and the 1-step Part 12 70 license.

13 So Part 70 is a 1-step licensing process, 14 so there are some differences and the key I think is 15 ensuring that whenever you seek to fulfill the 16 requirements of Part 70 that you provide all the 17 information.

18 MS. HAASS: Right.

19 MS. HELTON: There is different -- You 20 know, you have seen that the bar for the construction 21 permit, it's a different bar, you don't have a design 22 set and --

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102 1 to two because we have to have all of our finalized 2 design complete for the operating license under Part 3 50, which is then a 1-step process because the first 4 step has been complete, or we submit it under Part 70.

5 So if I make my question more precise, is 6 there a difference between providing the same 7 information, meeting all the regulatory hurdles under 8 the operating license for Part 50 in contrast to a 9 separate application on your Part 70?

10 MS. HELTON: It might be helpful to step 11 forward in the slides and see if we don't address 12 that.

13 MR. TIKTINSKY: Okay. Yes, see if we go 14 through and see if I answered the question or not.

15 MS. HELTON: Yes.

16 MR. TIKTINSKY: How about that?

17 MR. FOWLER: Okay.

18 MS. HELTON: Sure.

19 MR. TIKTINSKY: So, and, again, just the 20 thinker that if they are combined then we need to make 21 sure how they are met so it's clear to reviewers.

22 Forty-three. So to sort go with what we 23 have looked at, so from what we have received in the 24 docket so far the staff doesn't believe we have 25 sufficient information to do the conduct review of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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103 1 target fabrication scrap recovery activities right 2 now. So I think --

3 MS. HAASS: But it was never expected to 4 be at that level.

5 MR. TIKTINSKY: Yes. So it's just that, 6 that's my understanding that there was not.

7 (Simultaneous speaking) 8 MS. HAASS: Yes.

9 MR. TIKTINSKY: We just want agreement 10 then, we all agree that there is not, we don't believe 11 there is sufficient information.

12 And from our review of those activities, 13 you had mentioned in your application that you 14 believed they were under Part 70, so how we look at 15 them they, I guess the first part is they don't appear 16 to be covered by Part 50, so that's sort of, it's not, 17 it doesn't meet the definitions of production facility 18 under Part 50 and they appear to be subject to Part 19 70.

20 So that's sort of our looking at what --

21 Even, again, you have not submitted the application, 22 so it's hard for us to make a definitive, you know, 23 determination of what is there without that, but 24 that's what we believe at this time.

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104 1 the safety review and issue a license, because 2 obviously you would need to submit an application 3 meeting all the regulatory requirements.

4 And the burden is always on the licensee 5 to demonstrate that they, or the applicant and the 6 licensee to demonstrate that they meet regulatory 7 requirements.

8 The staff does findings of reasonable 9 assurance that you do meet them to protect the public 10 health and safety, but the burden is on the applicant.

11 Sort of in addition to or in lieu of for 12 some specific licensing questions related to, you 13 know, specific aspects of what's applicable, you know, 14 we talked we talked about pre-application meetings.

15 We would like to know, you know, if you 16 believe certain parts of Part 70 are applicable or not 17 applicable and have why they are not applicable we can 18 have pre-application discussions of them.

19 Again, going back to my first point of 20 making sure there is a good understanding of things 21 because for any facility pretty much in, or activity 22 in Part 70, there are some parts that apply and some 23 parts that don't apply just on the nature because Part 24 70 is a broad regulation.

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105 1 facilities, which is different than, you know, uranium 2 enrichment facilities, so there -- But the regulation 3 is written broadly, so, you know, your understanding 4 of what you think you need to meet, having discussions 5 on that would probably be useful to make sure we were, 6 you know, had some alignment, you know.

7 We don't want to play the bring me rock 8 where you just, you know, send something in and we say 9 no, you missed the mark, so we want to have those 10 discussions because there where you add to timeliness, 11 or had the time to doing a review if you do that.

12 So, you know, as we have mentioned, you 13 know, many times those communications and 14 understandings are really important to make sure we 15 hit the mark.

16 But, again, it is, you know, Northwest's 17 responsibility to demonstrate what they think they 18 meet, what you think activities apply, what 19 regulations do you think you meet, and how are you 20 going to demonstrate that they are met.

21 The Slide 44 talked a little bit about 22 schedule and, you know, Steve had presented a schedule 23 to you, and that was a very good outline of the types 24 of activities that get done in a review, so what I 25 present here is sort of, you know, if you were just NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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106 1 submitting a Part 70 application this is what we would 2 tell you that, you know, it's typically about 18 3 months to do a review.

4 We do a technical review of the 5 application. Again, whatever it was, if it was 6 submitted with the Part 50 or not we will do a 7 technical review of the applicable regulatory 8 requirements, issue additional requests for additional 9 information, draft a safety evaluation report, you 10 know.

11 There is slight differences in terms of, 12 you know, the process and terms of, you know, there is 13 not a mandatory hearing for this type of facility in 14 Part 70 compared to 50, so there's some, you know, 15 subtle differences.

16 But I guess the major point here is the 17 review can be done in parallel or a series, so it sort 18 of depends when you submit it.

19 So the 18 months I show here, you know, if 20 you wait until after you submit it and we reviewed an 21 operating license application under Part 50 then you 22 sent us one then that clock would start when you 23 submitted it.

24 If it's with it then we could do that 25 review in parallel, so it wouldn't be adding to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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107 1 time.

2 So, again, a lot of it depends upon where 3 you want to submit it, what is strategic, you know, 4 for your company, when you think you are ready to have 5 all the requirements.

6 And, again, in Part 70 the 1-step license 7 requires, you know, a further development of things 8 than a construction permit and it is also slightly 9 different than what's in an operating license.

10 Again, the regulatory requirements are 11 different so it doesn't necessarily line up 100 12 percent but it is your choice to, when your 13 information is available, that you think you can meet 14 to demonstrate the Part 70 then you can submit it.

15 If that happens to be with the operating 16 license that's perfectly acceptable to us. If it 17 happens to be before or after, I mean, again, that's 18 acceptable, you know.

19 Again, the key is to make sure that, you 20 know, you have an application that's complete, that 21 has all the applicable regulatory requirements 22 addressed.

23 MR. LYNCH: And just to add on, and I 24 think Dave is absolutely right. I guess what it comes 25 down to, I'm glad we're in agreement on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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108 1 information itself that needs to provided and I think 2 that the main comment in terms of what's more timely, 3 the sooner we have the information the sooner we can 4 begin reviewing it, if that helps you in planning when 5 you submit.

6 But I think from a Part 50 standpoint it's 7 important to think about, also, that is there still 8 related activities that are happening under the same 9 roof.

10 So in order for us to make our safety 11 findings under Part 50 for a production facility we 12 will be interested in how other activities happening 13 within that building could impact, and I'm sure it's 14 the same going both ways.

15 So while you can submit the information 16 whenever you would like to, it's all related and we 17 need to know the impacts that those activities will 18 have on the different, within the building on the 19 different other activities that are happening as well, 20 and whether it's the manufacturing of the targets or 21 the processing of those targets.

22 MS. HAASS: Well and that was the concept 23 of our Part 1, Part 2 submission was we showed an 24 overall facility, because you are trying to show all 25 the safety-related activities, you know, and how they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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109 1 interact with one another.

2 MR. LYNCH: Yes.

3 MR. TIKTINSKY: Yes, it sort of emphasizes 4 --

5 (Simultaneous speaking) 6 MS. HAASS: But I can't do one without the 7 other?

8 MR. TIKTINSKY: Yes, to emphasize Steve's 9 point, I mean we, you know, individually look at the 10 Part 50 portion of the facility we need to consider, 11 you know, an external, which isn't really external in 12 this case because it's maybe the room next door.

13 But you still have to consider those 14 activities in the Part 70 one and on the 50, and just, 15 and the same way we would, if you were just looking at 16 just the 70 piece in isolation we would be interested 17 in the impacts of what the Part 50 facility around it 18 was impacting on that in terms of, you know, accidents 19 and analysis and things like that.

20 So we would look at it both ways because, 21 again, we have to make a regulatory finding for those 22 specific parts of the facility for those parts.

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110 1 was, are there efficiencies with going one route 2 versus the other, submitting a separate standalone 3 Part 70 versus incorporating all of the, how you are 4 satisfying all of the requirements into the CP, is 5 that what you were asking?

6 MR. FOWLER: Yes. And, further, is there 7 a material difference between the strategy of 8 application submission?

9 And what I concluded from the conversation 10 there is not a material difference between submitting 11 under a construction, or an operating license out of 12 Part 50 in contrast to a separate and distinct Part 13 70, the same steps, that it's not going to be easier 14 for the NRC.

15 In many companies it would be easier to 16 have a separate Part 70 application because some of 17 the conversations could be more easily 18 compartmentalized even though they do relate to other 19 things.

20 What I concluded, rightly or wrongly, 21 there is not a material difference. And to be clear 22 from what's in my head there is a 2-month difference 23 right now between the critical path of us entering the 24 supply chain with quantities of moly under Part 50, a 25 2-month slip on the Part 70 puts Part 70 on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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111 1 critical path. That's how tight these two things are 2 together.

3 Plugging in all of the assumptions from, 4 well the guidance that we receive from the NRC, there 5 are only two months difference right now and so if 6 there were a material difference in review process 7 cycle time it could very easily affect the entrance of 8 this critical isotope into the supply chain.

9 That's how granular -- I manage the 10 schedule. We're down to a month.

11 MS. HELTON: So I think, you know, we've 12 emphasized the importance of communication on both 13 sides. You know, you want the frequent public 14 meetings, we can do that.

15 And I think what would be really helpful 16 is to have a public meeting or a series of pre-17 application meetings where as you solidify your plans 18 for your operating license and meeting the Part 70 19 that, you know, you keep us in the loop about how your 20 project plan is starting to -- and we don't need 21 those, necessarily all the details, but just in terms 22 of what you are thinking about how to meet the 23 requirements and going forward.

24 I've seen another complex application, I 25 was in operating reactor licensing before this job, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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112 1 where, you know, we've had as many or seven or eight 2 pre-application meetings to talk about each of the 3 different technical chapters and what they're going to 4 be doing to meet the requirements, and you might want 5 to consider doing something like that just so there is 6 no surprises.

7 MS. HAASS: And we have done that in the 8 past.

9 MS. HELTON: Yes.

10 MS. HAASS: Yes, so --

11 MS. HELTON: Yes.

12 MS. GAVRILAS: So just one reminder. This 13 is Mirela again. Just one reminder that these are 14 estimates, the timelines, and we try to walk you 15 through the parameters, that impact held with that 16 estimate that --

17 So it's almost like you are talking 18 project management, what we visualize in our mind is 19 sort of Gantt chart with the end in mind, you know, 20 how the review of these various activities basically 21 lead towards the point that which you get an operating 22 license.

23 MR. BALAZIK: This is Mike Balazik. Is 24 there any other questions on the Part 70 piece, 25 because now we're going to shift to something else?

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113 1 MR. ADAMS: And now for something 2 different.

3 MR. BALAZIK: All right, Al.

4 MR. ADAMS: So what I'd like to do is, you 5 know, we have discussed the, you know, general 6 requirements for licensing, your proposed activities, 7 you know, we discussed where the current status 8 review.

9 Using your cover letter for Part 2 of the 10 application and the NRC reply I'd like to try to pull 11 everything together and hopefully the goal here is to 12 reach a common understanding of how to move forward.

13 I am, you know, because of the excellent 14 presentations that came before me, you know, some of 15 this, you know, some of what I am going to say will be 16 redundant, but, again, repeating it in the light of 17 your application requests.

18 So, next slide. So, you know, here is I 19 think probably the most important statement from, well 20 one of the important statements from your cover 21 letter, that you are applying to the NRC to obtain a 22 license for a production facility under 10 CFR Part 23 50.

24 So, next slide. So I think, you know, we 25 understand that statement that you are looking for a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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114 1 construction permit for a production facility, you 2 know, to dig a little bit deeper that you are looking 3 for a license to construct a facility where you plan 4 to conduct activities to separate moly-99 from 5 irradiated uranium and other byproduct material.

6 That's consistent with the third 7 definition of production facility in 10 CFR 50.2.

8 There is three basic definitions of production 9 facility.

10 One is facilities that are involved in the 11 formation of plutonium, basically plutonium production 12 reactors. The other one are facilities that are 13 primarily separating plutonium, and there is the third 14 definition which is on the slide, any facility design 15 or used for the processing of irradiated materials 16 containing special nuclear material.

17 (Off the record comments) 18 MR. BALAZIK: This is Mike Balazik, please 19 Star 6 your phone to mute it. We can hear some 20 background conversation.

21 (Off the record comments) 22 MR. BALAZIK: This is Mike Balazik. We 23 are picking up some background conversation. I ask 24 you please mute your phone, Star 6.

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115 1 is a safety reason behind the definition and that's 2 when you are processing irradiated materials 3 containing special nuclear material basically you are 4 separating out fission products from irradiated 5 special nuclear material.

6 That involves additional hazards from what 7 you would see in what I would call traditional fuel 8 cycle facilities, the fact that you are dealing with 9 irradiated material.

10 You are dealing with fission products, 11 radioactive material, gaseous fission products, which, 12 you know, which creates different accident scenarios 13 and potential for dose.

14 So that's sort of the theory and the idea 15 is once you introduce these irradiated materials that 16 your intensity of our Part 50 where we are interested 17 not only in the materials, the licensing of the 18 materials, but also the licensing of the facility that 19 contains the materials.

20 The third definition does contain some 21 exceptions and you have indicated that you are not 22 looking to license under any of those exceptions and 23 those exceptions are that basically your separation is 24 being done on a laboratory scale, so that's the first 25 exception.

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116 1 The other one is if you are, that if your 2 batches are less than 100 grams of uranium then it's 3 not a production facility. You indicated that your 4 batches will be greater than 100 grams of uranium.

5 And the third is that if the irradiated 6 material that the fission product concentrations and 7 the plutonium concentrations are less than the cutoffs 8 in the definition then you are not a production 9 facility.

10 So you indicated that you are not looking 11 to fall under any of those exceptions, which means you 12 are a production facility under Part 50.

13 Next. So here is another statement in 14 your letter to us.

15 (Off microphone comment) 16 MR. ADAMS: Oh, I'm sorry. Yes, that's 17 what it says here. So, I'm sorry, this is our letter 18 back to you where we completed the review and we agree 19 that you have an application for a construction permit 20 for a production facility as defined in 50.2 and 21 you've met the requirements of 2.101(a)(5) and the 22 information required by 50.34 and we found your 23 application acceptable for docketing.

24 So based on that we are going ahead and 25 reviewing the application for the production facility.

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117 1 Okay, now Slide 49.

2 So in your cover letter you discussed your 3 intent to apply for a single part, a 10 CFR Part 50 4 license. You indicated following NUREG-1537 and you 5 also referenced the regulations in 50.31 and 50.32.

6 Slide 50. So just to repeat what 50.31 7 and 50.32 say, so the regulations in Part 50 allows 8 combining of applications under Chapter 1 of 10 CFR 9 and Chapter 1 is all of the NRC regulations, so we, 10 you know, so applications can be combined.

11 And there is a regulation 50.32 and there 12 is a parallel regulation in Part 70, 70.21, and they 13 allow an incorporation by reference information 14 contained in, you know, previous applications, other 15 information. The requirement is that the references 16 are clear and specific.

17 Slide 51. So your cover letter referred 18 to NUREG-1537. I assume that when you say NUREG-1537 19 you are referring to the ISG, that augmented 1537 --

20 MS. HAASS: Correct.

21 MR. ADAMS: -- which provides applicable 22 guidance for licensing radioisotope production 23 facilities and aqueous homogenous reactors, you know, 24 the guidance on aqueous homogenous reactors isn't 25 applicable to your proposed facility.

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118 1 NUREG-1537 has a couple of statements that 2 are applicable to what you are proposing on doing 3 here. Section 9-5 of NUREG-1537 contains guidance 4 that materials used in the production facility license 5 need to meet the regulatory requirements for that 6 material. In other words, special nuclear material 7 needs to meet the regulations in Part 70.

8 NUREG-1537 also says that materials 9 required to operate the utilization of a production 10 facility can be included in the license and this 11 permits the combining of licenses.

12 Fifty-two. So your cover talked about 13 embedded in the 10 CFR 50 license facility activities 14 under Part 70 and Part 30.

15 Slide 53. As I mentioned, as discussed in 16 Section 9-5 of NUREG-1537 the Part 50 license can 17 include other activities, however, the issuance of a 18 Part 50 license doesn't automatically include other 19 activities, other licenses.

20 For example, you know, Part 70, Part 40, 21 Part 30 licenses. These licenses are combined only in 22 the Part 50 license if the applicant has submitted the 23 needed information and the applicable requirements.

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119 1 permit application has the information required to 2 grant the additional licenses and I think we're 3 looking for a better understanding of what you mean by 4 when you say "embedded activities."

5 Next slide. So this is an example of a 6 Part 50 utilization of an operating license. We call 7 them included activities. What I am looking for is to 8 understand if our included activities are the same as 9 your embedded activities.

10 As you can see in this license the 11 different licensing clauses. Number 1 on this slide 12 that is the license for the facility, so that's where 13 the license is granted for the Part 50 facility. This 14 is an example of a Class 103 license, which is similar 15 to the Class license you are looking for.

16 Where you see the three dots, where you 17 see the dots there and that phraseology, that just 18 listed who the licensees were and for this particular 19 facility there was a very long list of applicants.

20 And so Number 2 is you see an included 21 activity, so you can see this is the Part 70 clause so 22 the included activities to receive, possess, and use 23 at any time special nuclear material, in this case 24 it's reactor fuel in accordance with the limitations 25 for storage and the amounts required for reactor NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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120 1 operation as described in the application.

2 And you can see in Number 3 there is Part 3 30, 40, and 70 license to receive byproduct, source, 4 and special nuclear material falls under other uses, 5 neutron sources for startup, sealed sources for 6 instrumentation, calibration, radiation monitoring, 7 fission detectors.

8 Number 4 is a clause, it's a reactor 9 clause. It's Part 30, 40, and 70, you can see, to 10 receive, possess, and use in any amounts is required 11 in any byproduct source of special nuclear material, 12 so you can see the included activities.

13 C is just a reiteration that even though 14 it's a Part 50 license that the activities under the 15 other parts, 40, 30, 70, need to follow those 16 regulations. So that's how these concepts are put in 17 place in the license.

18 So, 55. You mention that the RPF will 19 include the fabrication of LEU targets which will be 20 licensed under 10 CFR Part 70.

21 Fifty-six. So, you know, we understand 22 that, you know, you understand that the fabrication of 23 targets is under 10 CFR Part 70 as we discussed 24 several times and this was reflected in our docketing 25 acceptance letter which stated that staff expects that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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121 1 and Northwest will submit an application for 2 fabricating low-enriched uranium targets under 10 CFR 3 Part 70.

4 And next is 57 --

5 MR. FOWLER: So I want to --

6 MR. ADAMS: Yes?

7 MR. FOWLER: Al, I I'd just to clarify 8 that.

9 MR. ADAMS: Sure.

10 MR. FOWLER: Part of what triggered a 11 serious of conversations was the meeting immediately 12 preceding Thanksgiving in which our internalization of 13 the communication was a requirement to bifurcate our 14 application between Part 50 and Part 70.

15 I was on the phone and I explicitly heard 16 that there would be a separate requirement for a Part 17 70 application, where previously we had socialized, 18 and I'll use the term socialized because it was only 19 discussed, socialized and put embedded activities, our 20 assumption that everything would be under Part 50.

21 So now 2-1/2, three months later I'm 22 understanding the language differently, which so long 23 as the information is there it can be either under the 24 50 umbrella or separate.

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122 1 license, but, you know, there is choices on how you 2 put in your application, there choices on how the 3 license looks.

4 However, to get from Point A to Point B we 5 need to follow the regulatory lane for that activity.

6 In other words, because I give you a Part 50 license 7 it doesn't automatically spawn these other licenses.

8 The Part 50 license by itself is a, you 9 know, is a license for a very expensive building 10 without, you know, without the other, you know, 11 without possession of material that building doesn't 12 do very much.

13 So I think that's the nuance that I think 14 we kind of missed in the conversations back and forth, 15 and I hope we have clarified.

16 MS. HELTON: Yes. Just to add to that, I 17 agree. This is Shana Helton for the phone. The point 18 I think back at the Thanksgiving meeting that is being 19 reinforced today is that we need to see something from 20 you that demonstrates compliance with the requirements 21 in Part 70.

22 MS. HAASS: There was --

23 MS. HELTON: Right. So I think that's --

24 (Simultaneous speaking) 25 MS. HAASS: Right, but there was never any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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123 1 disagreement with that when we were socializing it 2 when we had originally sent our letter over a year 3 ago.

4 MS. HELTON: Right.

5 MS. HAASS: There was no disagreement on 6 that, but there was a 1-step process versus a two, you 7 know, and, you know, there is a nuance and, you know, 8 we agree with that.

9 I mean what we need to do today is move 10 forward and we understand completeness, we understand 11 compliance, and we will get back with you on how we 12 plan on dealing with the Part 70, if it's going to be 13 combined with 50 or not.

14 MS. GAVRILAS: This is the main objective 15 of this meeting. We need to make sure that all the 16 areas where there is uncertainty, where we are not 17 aligned, today is our opportunity to address them.

18 You know that's why we exchanged the 19 topics that we covered today with Carolyn before the 20 meeting to make sure that everything that we are 21 presenting here does address your concerns and does 22 actually get us to the point to which we can align on 23 the things that have some uncertainty associated with 24 them.

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124 1 everyone's head nodding that we are now in alignment 2 with respect to the previous kind of crosswise 3 communications on 70 and 50 and for that we can 4 successfully tick off that as we have met that 5 objective of the meeting.

6 The second and broader objective of the 7 meeting was to explore how we ensure that we most 8 efficiently accelerate the schedule to meet the needs 9 that we all recognize in the United States.

10 So I appreciate that we can tick off that 11 first objective of the meeting successfully.

12 MR. ADAMS: And I think I have one more 13 slide. Number, I think Slide 57. So that the current 14 application that you are not, at this point you are 15 not seeking an operating license for the proposed 16 facility.

17 This is a discussion we would like to have 18 with you today to the extent, you know, that we can 19 have it as to what your plans are for submitting your 20 operating license application because that does 21 influence timing, that does influence, you know, what 22 we do on, you know, what we need to do and what you 23 need to do, too.

24 So, you know, that's an area that we need 25 to, that we'd like to understand better for, we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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125 1 prepared.

2 The second point, current application does 3 not request a license to produce SNM for the 4 fabrication of LEU targets, I think we beat that one 5 into submission.

6 MS. HAASS: Well it doesn't, it's not a 7 current operating license application.

8 MR. ADAMS: That's right, it's not.

9 MS. HAASS: It's Part 70.

10 MS. HELTON: Right.

11 MR. ADAMS: Yes. That's right, and that's 12 a separate point from my first one.

13 MS. HAASS: Right.

14 MR. ADAMS: And a facility can have 15 multiple licenses, that a single building can be a 16 place of use under multiple licenses.

17 When I was a licensee my containment 18 building was a place of use under my reactor license, 19 it was a place of use under our NRC SNM license, it 20 was a place of use under a state byproduct license.

21 The important thing, which I think Dave 22 and Steve alluded to, is we need to look to make sure 23 that those multiple activities don't impact the safety 24 of each other.

25 MS. HAASS: Yes.

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126 1 MR. ADAMS: So that's the important thing, 2 but there is no rule that says that, you know, a 3 certain piece of turf can only, you know, can only be 4 occupied by one license, and I think that is 5 consistent with what we have discussed today.

6 So like I said I think the, you know, 7 before the day is out we would like to discuss, you 8 know, what are, you know, your plans for moving 9 forward with your operating license application for, 10 you know, for we understand them and we can be, you 11 know, prepared.

12 That's it for me.

13 MR. BALAZIK: All right. Real quick, this 14 is Mike Balazik again, and I know we have touched on 15 some of these topics but I just want to reemphasize 16 them.

17 On communications, that internal and 18 external communications is important to support a 19 quality and timely application review. I just wanted 20 to go through some of those channels that we have 21 already set in place.

22 One that Shana mentioned early in the 23 meeting about essentially one-stop shopping, that I am 24 your contact even though you've got, down the road 25 there is potential licenses, I am your main contact, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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127 1 and, you know, on a lot of our calls, on our weekly 2 status calls I'll have Dave and Nancy on those calls.

3 The next item, clarifying, calls for REIs.

4 We've done a couple of those for the environmental and 5 we plan to continue those for the safety, sharing 6 those RAIs with you draft form, make sure there is an 7 understanding, and if there is not, you know, we can 8 discuss it and even modify the RAIs so that it is 9 clear.

10 Since we are discussing RAIs I'd just like 11 to share one item for thought going forward. Even 12 though there is no regulatory requirement to update 13 your PSAR, we've seen a good practice, or identified 14 a good practice that if you update your PSAR with the 15 RAIs that that can also lead to a timely review, but 16 even future steps it will help us, to keep your 17 updated PSAR.

18 But realize there is no, you know --

19 MS. GAVRILAS: I'll just mention one 20 thing, ACRS. It's easier for the ACRS, we accept your 21 responses, right, as a supplement to your submission, 22 they become part, they are docketed and they become 23 part of the docket.

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128 1 as possible.

2 We were talking about places where 3 efficiencies can be realized, that's a place where an 4 efficiency can be realized.

5 MS. HAASS: So a good example is the RAIs 6 we have received on Chapter 19. We've already updated 7 Chapter 19. You have not received it, but we have 8 already updated it.

9 We actually when we get them we do it 10 right then and there. I am more than happy to provide 11 you an updated 19 if you want it right now. I don't 12 know why we'd need it right at the moment, but we will 13 be providing a revised PSAR with all the RAIs. It's 14 already in the plan.

15 MS. GAVRILAS: That's terrific.

16 MR. TIKTINSKY: The practice that we find 17 that works a lot is sometimes, you know, answers to 18 RAIs are long but changes to the applications don't 19 necessarily, aren't -- Well you might change one thing 20 in an application and have a 3-page thing backing it 21 up.

22 MS. HAASS: Right.

23 MR. TIKTINSKY: So at the end of the day, 24 at the end of the review it's good to have one 25 application that we know everything that's in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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129 1 application that we can write an SER against rather 2 than writing SERs against all these little sort of 3 sidebar discussions.

4 So, again, as Mike said it's not a 5 regulatory requirement but it's certainly an 6 efficiency that we found in not only 50 reviews but 7 certainly in 70 reviews also.

8 MS. HAASS: But remember it's difficult 9 for us to manage if we don't do that. That makes us 10 inefficient, so it's only good practice on our part 11 and to move forward to the operating license.

12 MR. TIKTINSKY: That could be changed 13 pages, you know. It doesn't have be, you know, every 14 time you make something it doesn't need a whole 15 chapter, it's just whatever related to, you know, the 16 change from an RAI and is, you know, and you manage it 17 however you find most efficient.

18 MR. BALAZIK: All right. Another item, 19 responsiveness, we've also talked about that, 20 especially timely response to RAIs and when we share 21 the draft RAIs if there is something that you see in 22 there that you can't get in 30 days or a certain 23 timeframe just let us know.

24 Let us know that this, hey, we can answer 25 RAIs 1 through 5 but, you know what, six is going to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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130 1 take us a little bit longer. You know, we just need 2 that communication back and forth that there may be 3 something up there that may take a little bit longer.

4 Quality of submissions, we also talked 5 about this, identifying proprietary information, 6 removing that, and just that answers are complete.

7 Also, just clarify previous communications 8 or socializing. We mentioned this earlier that no 9 regulatory decisions are made in public meetings and 10 that public meetings are not a substitute for 11 submittal of information on the docket and also that, 12 you know, we don't make decisions on our weekly calls.

13 And, finally, just that the NRC has an 14 opening policy and if we chose to close a meeting, you 15 know, it's reserved for information that must be 16 withheld in accordance with our regulation.

17 So that's pretty much it for 18 communications. I don't know if anybody else wants to 19 add -- Yes?

20 MR. LYNCH: I just wanted -- I was really 21 glad to hear that we were able to meet one of your 22 objectives in terms of licensing, that we have a 23 shared understanding that additional technical 24 information is needed for, to meet Part 70 25 requirements and how you choose to submit that is up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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131 1 to you and regardless of how it is submitted it's 2 still the same technical information that we are 3 looking for. I'm glad we've got that objective met.

4 I want to make sure that we can also 5 hopefully meet that second objective that you stated 6 at the beginning, which was exploring mechanisms to 7 expedite the review.

8 I tried making a summary. I think Mike 9 highlighted them and I just kind of want to read 10 through those again and make sure that we understand 11 everything you are looking for and to reiterate our 12 points that can help facilitate that expedition.

13 One of those areas we've talked a lot 14 about, RAIs, trying to reduce the number of rounds of 15 RAIs and even the total number of RAIs, things that 16 can go that, the quality of your responses, 17 completeness and the timeliness, we explore different 18 ways of communicating that to help facilitate that.

19 Mike has his weekly status calls. We have 20 talked about -- and on the status calls we can make, 21 talk further about if we want to set up standing 22 public meetings. If that can help we can certainly 23 get those set up as well.

24 And broader with communication, you know, 25 those weekly status calls are good opportunities to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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132 1 identify problems you see coming down the road that 2 we, both parties can be thinking about and, you know, 3 maybe it's not something we address immediately, but 4 at least we can put them on the list of things NRC 5 needs to think about and things that Northwest needs 6 to think about, and they can topics of future public 7 meetings.

8 We can also talk about, you know, email 9 communication works, too, send emails. You can update 10 and propose topics that we can have on those weekly 11 calls, topics for public meetings, if we can get 12 those, and it helps, too, we can discuss ahead of time 13 before we have those calls.

14 Al touched on this, also that's important 15 to us is updates to your schedule. This can be 16 updates as Mike was talking about with responses to 17 RAIs.

18 If it's going to take you a little bit 19 longer to get certain responses to us work that out 20 with Mike, let us know what's going on with your 21 schedule so that we can plan and make sure that we 22 have people available and ready to review your 23 responses when they come in.

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133 1 license application, helping us have a good idea of 2 when that's coming in to make sure that we have people 3 ready to review it when it comes in.

4 So letting us know delays that might come 5 up or if your schedule is getting pushed up, it helps 6 us align our budget and our resources to make sure 7 that we are ready for your application.

8 We also talked about pre-application 9 meetings. So when you are getting ready to submit 10 your next application for your operating license we 11 can have meetings ahead of that submission to make 12 sure that we have a shared understanding of the 13 information that's coming in that and have discussions 14 about that so it helps encourage that a quality 15 submission comes in for your operating license and 16 could help potentially reduce that review time as 17 well.

18 In talking about the operating license 19 application I wanted emphasize again, because 20 ultimately we complete this construction permit review 21 in our 18 to 24-month timeframe, we're still 22 anticipating an additional 18 to 24-month review for 23 the operating license application, and I understand 24 it's critical that we can get that review done 25 efficiently as well.

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134 1 So I think for those exploring, those pre-2 application meetings can be a good way of getting us 3 started on that review and knowing when it's coming in 4 can help us be prepared.

5 We highlighted following the guidance.

6 You can gain insight from NUREG-1537, the ISG, our 7 standard review plan, so you know exactly what the NRC 8 is looking for when we review the application that you 9 sent in, also looking at past applications that have 10 come in to get ideas of questions we have asked in the 11 past and the level of detail of information that we 12 found acceptable in the past.

13 We also talked about reducing 14 administrative time so that we don't have time that's 15 spent with people not doing anything, and I think 16 that's good and I think those weekly calls, again, are 17 going to be crucial to reducing that administrative 18 time for processing.

19 And Mike highlighted again at the end 20 updating the application as you are responding to 21 RAIs. That was my list. Were there other things that 22 I missed that we can --

23 MR. ADAMS: There's probably one I want to 24 touch on. I think I touched on it briefly and that's 25 the operating license application.

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135 1 The last research reactor that we licensed 2 submitted a complete application at the construction 3 permit stage so our review was for both the 4 construction permit and the operating license at the 5 same time.

6 Obviously, that has the potential to, you 7 know, reduce the review time significantly so that's 8 why we are interested in knowing what's your timing on 9 your operating license that, you know, that has an 10 effect because, you know, the theory is that the 11 construction permit you've given us so much of, say, 12 you know, your complete design that you've given us so 13 much of that design and, you know, there is enough 14 there to make a decision to allow the facility to be 15 constructed and then the rest of the details on the 16 design come in with the operating license that, you 17 know -- so there is a lot of variability what that, 18 you know, what those parts, you know, what those two 19 parts look like.

20 The first part is here, you know, what 21 needs to come in to fill and, you know, to fill in the 22 rest of the information and when that information is 23 coming in I think is important, you know, in the 24 discussion of, you know, how to change the, you know, 25 the timing of this and, you know, not only, you know, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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136 1 talking talk the timing from, you know, the beginning 2 to you have an operating license.

3 MR. TIKTINSKY: If I add a little emphasis 4 from Steve's point on the Part 70 side, you know, 5 there is many examples of the kinds of the RAIs that 6 we have asked for Part 70 applications as well as 7 SERS, so you can sort of see when we write up things 8 related to 1520 what the kind of things we're looking 9 for, the kind of questions we had.

10 And, also, you know, emphasizing of the 11 use -- You've got multiple things here, the use of 12 crosswalks, you know, again, the clearer that you can 13 make it that we understand where the information is 14 the easier it will be for the reviewers to get the job 15 done and minimize questions of because we just can't 16 find information.

17 MR. FOWLER: So to the list that Steve 18 summarized very nicely I would add a program/project 19 management process, just as I manage a program inside 20 of a private company I have far less insight into the 21 detailed activities in what's happening at the NRC and 22 whether we're on track, off track, what are the 23 constraints, what are the barriers, those kinds of 24 things.

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137 1 management structure I think is very, very important 2 to keep things on track.

3 MS. HAASS: Yes.

4 MR. LYNCH: And I think to that, yes, I 5 think it's very important from both sides to keep each 6 other updated on where we are at in our reviews and I 7 think with the calls we can do that.

8 Also, what we're going to try doing is, 9 you know, keep you updated on our overall review 10 schedule. We have this initial review schedule that 11 we shared here today on our slides, but as things come 12 up that may necessitate that changing, either 13 expedited or delays, we need to communicate that to 14 you as soon as possible, and that's a commitment that 15 we can make as well.

16 We are also going to, you'll be seeing 17 shortly, we're working on developing a public website 18 that should be going live in the next couple weeks 19 that you can be able to also have all of your 20 application data displayed as well, that can be easily 21 accessed and see our review schedule.

22 MR. ADAMS: The public --

23 MS. HAASS: The public would -- Sorry.

24 For Northwest Isotopes or for other things as well?

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138 1 and general moly-99.

2 MS. HAASS: Okay, got it.

3 MR. ADAMS: And your public information, 4 not your --

5 MS. HAASS: I understand.

6 MR. LYNCH: But, yes, and, you know, as we 7 continue with the review I'm sure both sides will have 8 new ideas.

9 MS. HAASS: Yes.

10 MR. LYNCH: So chair them and we can 11 continue to improve.

12 MR. BALAZIK: All right. At this point 13 we're a little ahead of schedule. Our senior managers 14 want to come down for our closing remarks and summary.

15 The timeframe for that is 2:30, but I 16 wanted to ask Northwest if they had additional 17 discussion they want to do in the afternoon on any of 18 the topics we presented, any topics that we didn't 19 present today that they would like to discuss in a 20 public meeting. I've got that scheduled for 1:30 and 21 lasting about an hour.

22 MS. GAVRILAS: Yes, I have a suggestion, 23 that we mull over everything we have heard and perhaps 24 after lunch we reconvene and that will be the time, 25 unless you want us to research something over lunch.

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139 1 It's going to be after lunch we reconvene 2 and we sort of discuss any outstanding items, how's 3 that?

4 MS. HAASS: That's fine.

5 MR. FOWLER: Sounds good.

6 MR. ADAMS: And another question, is, you 7 know, giving us information on where you see your 8 schedule moving forward, you know, especially giving 9 us the operating license application, is that 10 something that you are prepared to talk to us today in 11 this swarm or --

12 MR. FOWLER: We would certainly be 13 prepared to respond and provide some answers in a non-14 public format, as it's dependent upon a lot of the 15 questions that were asked of us that are of a 16 proprietary nature to come up with the anticipated 17 scheduled.

18 MR. ADAMS: Okay.

19 MR. BALAZIK: Okay.

20 MS. GAVRILAS: Enjoy lunch.

21 MR. BALAZIK: Yes.

22 MR. ADAMS: What time --

23 MS. GAVRILAS: We'll reconvene at --

24 MR. BALAZIK: Well let's reconvene at 1:30 25 for discussion of additional topics and then at 2:30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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140 1 we'll do the closing remarks.

2 MS. GAVRILAS: Yes. And we have an 3 opportunity before the public to --

4 MR. BALAZIK: Yes, we're going to do that, 5 too, yes.

6 MS. GAVRILAS: So we need to stick to the 7 agenda because --

8 MS. HAASS: Is there any opportunity for 9 a non-public portion of this?

10 MR. BALAZIK: No, there is not.

11 MS. HAASS: Okay.

12 MS. GAVRILAS: So we need to stick to the 13 agenda because the agenda is made available so that 14 everybody can listen, so we'll just meet back at 1:30 15 and we'll talk more then.

16 MS. HAASS: Right.

17 MR. FOWLER: Very good.

18 MALE PARTICIPANT: Thank you.

19 MR. BALAZIK: This is Mike Balazik. We'll 20 be coming back at 1:30 and we're going on mute until 21 then.

22 (Whereupon, the above-entitled matter went 23 off the record at 11:32 a.m. and resumed at 1:35 p.m.)

24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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141 1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2 (1:35 p.m.)

3 MR. BALAZIK: Hi, this is Mike Balazik, 4 and we want to resume the public meeting with 5 Northwest Medical Isotopes. Right now in the agenda 6 we have Northwest Medical Isotope topics. If there's 7 anything that Northwest wants to discuss with the 8 staff?

9 MR. FOWLER: We did not have topics in 10 public form. We'll arrange a separate non-public 11 meeting to discuss some topics.

12 MS. GAVRILAS: Mike, you want to talk 13 about the setting up closed meetings please, because 14 apparently there was some miscommunication on what 15 requirements we must need before we can do that.

16 MR. BALAZIK: Yes, the requirements for a 17 closed meeting is to submit an affidavit with the 18 letter, but with the specific topics that are going to 19 be discussed in the closed forum.

20 So then what we would do is we would look 21 at those topics and agree that yes, these are proper 22 to be discussed in a closed setting vice an open 23 public meeting.

24 So in the affidavit that was provided, I 25 felt that it was very general, and I received some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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142 1 advice that it did not contain sufficient detail to 2 close the meeting.

3 MS. HAASS: And as discussed with you, we 4 were, we didn't quite know what would be in the non-5 public forum because this discussion had to occur and 6 that's why it was general. So it's not that we didn't 7 understand, it was because of how the meeting was set 8 up.

9 MS. GAVRILAS: I understand. So the other 10 thing that we tried to see is if it's okay for us to 11 close a portion of this meeting. So that was the 12 homework we did during lunch. And we were advised 13 that that's not okay because the topics need to be 14 submitted by affidavit. So we tried.

15 MS. HAASS: It's a catch 22.

16 MS. GAVRILAS: Yes.

17 MS. HAASS: But no, we do understand, you 18 know, the requirements for a non-public meeting. But 19 we just didn't have enough data to be able to give you 20 any more specifics.

21 MR. LYNCH: That's understood. Well 22 maybe, if we have some time maybe we could use for 23 time our over here is to maybe make a list of some 24 action items that we can take for going forward, and 25 this could include topics for future meetings that you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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143 1 might like to have, things you would like to see, and 2 other things you would like to go forward on both 3 sides that we can take back and then we can get back 4 to each other on. Does that sound like something you 5 would like to go over?

6 MS. HAASS: I would say we can take some 7 action items. But just as long as we know it's 8 subject to change because, you know, I still have some 9 discussions I need to do.

10 MR. LYNCH: Understood, understood. Yes, 11 this is not meant to commit you to anything. This is 12 intended to help us get an idea of when we leave here 13 today what should we be most focused on, aside from 14 reviewing your application.

15 Mike, did you want to lead with any topics 16 there?

17 MR. BALAZIK: One thing we've discussed 18 before, and again stop me if we're going into 19 proprietary information. But one thing we've 20 discussed in the past is facility design, final 21 design.

22 And what we've talked about earlier are 23 our resources for future applications, future 24 submittals. Is it possible we could get some sort of 25 idea of how far down that path Northwest is?

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144 1 MS. HAASS: I think we can state that we 2 are in the process of finishing our final design. But 3 from a schedule perspective, that would have to be 4 discussed in a closed session.

5 MR. LYNCH: Yes, I think the topic from 6 that is what, something the NRC is interested in 7 understanding better from you is when will your final 8 design be complete, and also how do you think you 9 might consider submitting that because there are 10 different ways that the final design can be provided 11 to the NRC.

12 The final design can be provided as part 13 of your operating license application, or you can 14 amend your current construction permit with additional 15 design information as you finish it.

16 And however you choose to do that is fine.

17 But it does help us to anticipate when that 18 information might be coming in. So that's just, that 19 is a topic that would be useful for us to discuss in 20 the future.

21 MS. HAASS: Well, and I would be 22 interested, because this is the closed question, what 23 have you preferred in the past? Would you like to see 24 it, like, you know, before the operating license 25 submission with the, maybe the finalization of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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145 1 construction permit.

2 I mean, I don't know. I mean, I don't 3 know what's the best timing for you guys I guess I 4 would ask. And then, you know, we'll try and work 5 that into a schedule.

6 MR. LYNCH: I think for us, you know, 7 we're willing to work with you with whichever way you 8 would prefer. You know, we haven't done something 9 like this in a very, very long time. So I don't know 10 if there's a lot of precedent we can necessarily point 11 to.

12 But I think we want to work with your 13 proposal. And by notifying us when it's coming, we 14 can make sure we have the appropriate resources 15 available for that.

16 MR. ADAMS: This is Al. I think, you 17 know, the understanding of the timing is important 18 because we're going to, you know, spend time and 19 effort reviewing what you've given us.

20 And if we're 85 percent complete with that 21 review and all of a sudden we have a whole new bunch 22 of information, it might be advantageous to finish 23 that 15 percent, take that licensing action and then 24 try to reset, try to, you know, blend those two 25 together and start reviewing sort of an expanded NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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146 1 scope.

2 So you know, part of it depends on the 3 timing versus if we're only, like, ten percent into 4 looking at something and the new information comes in, 5 then the effort or cost of changing your direction, 6 changing your scope is minimal. So I think that's an 7 important solution.

8 MR. LYNCH: Maybe that's a better way to 9 capture what we can provide that too. We won't advise 10 you on which way is better than the other. But we can 11 discuss, as Al was going to, what potential impacts of 12 your decisions could be.

13 MR. BALAZIK: This is Mike Balazik. I 14 guess another potential item is exemptions. I don't 15 know if Northwest has looked at any potential 16 exemptions that could come down the road that we could 17 be aware of or could prepare for, just kind of another 18 item that would benefit us in future reviews on 19 exemptions.

20 MS. HAASS: Okay.

21 MR. LYNCH: And even more broadly, just 22 other licensing actions in addition to your primary 23 construction permit or operating license, or material 24 license and application that we might need to consider 25 and the timing. And for example, that could include NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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147 1 the other research reactors that might be seeking 2 amendments to support that, knowing the timings that 3 those licensing actions can help us as well.

4 MR. ADAMS: Another example would be if 5 there's any need for shipping packages that would be 6 unique to what you're doing that, you know, don't 7 exist. That's another part of NRC and that's, you 8 know, a discussion that they have their own timelines 9 for doing that type of work.

10 MS. HAASS: And we've had brief 11 conversations with the other organizations, too.

12 MS. YOUNG: And that's under Part 71.

13 MR. LYNCH: Another topic that, you know, 14 that I think we could discuss going forward to our, 15 we've touched on the topic of potentially setting up 16 standing public meetings.

17 Put that on the list of establishing if 18 that's something that you want to pursue, what you 19 think appropriate frequency for those meetings might 20 be, what topics you might want to discuss during 21 those. I think that, I took that as one of the take-22 always I had from earlier today as a topic we should 23 explore further.

24 MR. BALAZIK: I guess, this is Mike 25 Balazik again, for expectations for interactions with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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148 1 the NRC for the environmental review, we're pretty 2 much had a set process. I mean, is there any 3 recommendations on communications that you would like 4 to see in the future?

5 MS. HAASS: Just want to make sure that 6 the RAIs get reviewed prior to going out final to make 7 sure there's no business sensitive information in 8 there. If you can at all let me know the possible 9 timing when that's going to come in, you know, we have 10 a lot of things going on as well and I need to make 11 sure our resources are there.

12 And I know when we get into the safety 13 aspect it can get more and more difficult, you know, 14 to get those reviewed, and what resources that means 15 to us as well.

16 Also from, Nancy, from your perspective, 17 I mean, you'll have another public-type meeting within 18 the NEPA realm. And you know when you're going to be 19 scheduling that. I know that the City of Columbia was 20 asking me that question as well.

21 I just know, you know, they told me they 22 would really like to help you do that. And I know 23 last time you guys went and did that, you know, 24 independently which is fine, but they're also willing 25 to go help as well. And, you know, you have their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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149 1 contact information now.

2 MS. YOUNG: Okay, thank you.

3 MR. LYNCH: Were there any topics that 4 you've had in mind in addition to that that you would 5 like to focus on in the future?

6 MS. HAASS: No. I think when you start 7 looking at schedule, the other licensing actions and 8 the same in the public meetings, that's really where 9 we want to focus with you guys.

10 Obviously, the standing public meetings, 11 you know, we'll assume that there will be some closed 12 portions of those meetings within that, you know, with 13 the appropriate documentation, understand that.

14 MS. GAVRILAS: Mike, you'll need to 15 elaborate on the process. I think we need the 16 affidavit with sufficient detail --

17 (Simultaneous speaking) 18 MS. HAASS: Oh, that's what I just said.

19 Right, no --

20 MS. GAVRILAS: So that's --

21 MS. HAASS: I said with the appropriate 22 documentation there would be closed portions as well 23 because there are certain things that, you know, that 24 are technically sensitive as well.

25 MS. GAVRILAS: Sure.

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150 1 MS. HAASS: And so any time we have a 2 topic, assume that there's going to be some, there's 3 most likely going to be something business sensitive 4 in there if it has anything to do with some details of 5 the facility.

6 MR. TIKTINSKY: You don't want to forget, 7 Dave Tiktinsky, the security related information 8 aspects of public meetings with technical discussions 9 which is different because that's a different part of 10 the regulations.

11 MS. GAVRILAS: Definitely.

12 MR. TIKTINSKY: So that's always something 13 we want to make sure that, you know, why we close 14 meetings related to discussions of that and 15 information that's the integrated safety analysis or 16 things that are preferably security related.

17 MR. BALAZIK: Anybody have anything else?

18 MS. GAVRILAS: Open it to the public I 19 would say.

20 MR. BALAZIK: All right, we can open up to 21 the public. Actually, I do have one more item.

22 Karen, you mentioned resources. Is there the 23 potential for any impact in the future for Northwest 24 resources for the review of this application, or even 25 future applications? There would be no change or any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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151 1 fluctuations that could potentially happen?

2 MS. HAASS: Well, there's no change in our 3 primary subcontractors, no.

4 MR. BALAZIK: Okay.

5 MS. HAASS: And they have the people to 6 support this. But, you know, you still have to 7 schedule it.

8 MR. BALAZIK: Yes, no. I understand, I 9 understand.

10 MS. HAASS: So yes, but that is not going 11 to change.

12 MR. LYNCH: I guess maybe just as a 13 closing question, do you feel like your expectations 14 were met today? Did we accomplish what you wanted to 15 accomplish at this meeting, or at least start moving 16 in the right direction?

17 MR. FOWLER: So we had two objectives as 18 we introduced this meeting from a Northwest Medical 19 Isotopes perspective. The first was gaining alignment 20 around or understanding in common of the licensing 21 application process.

22 And that one we've I think beaten to death 23 and are in violent agreement now with an understanding 24 from both NRC and from Northwest Medical Isotopes of 25 the options. And the follow up next step on that is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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152 1 to telegraph to the NRC our intentions. And so I 2 think from a first objective standpoint, we can 3 declare success on that one.

4 The second, and frankly more important one 5 to the nation and to public health and to public 6 safety is the speed with which we can accomplish a 7 successful review within the guidelines and 8 regulations.

9 I think this is, we did not have an 10 expectation that that would be solved in this meeting 11 today. Our expectation was that we would have a plan 12 to get to a plan.

13 What we accomplished in my view today is 14 I've received more granularity in the schedule 15 elements from the NRC and the assumptions behind the 16 schedules, how many iterations of RAIs, how many 17 iterations for the RCS and so forth.

18 So I think we now have a framework with 19 which we can succeed in a productive conversation on 20 translating the list, Steve, that you've so well-21 articulated and added to and convert that into an 22 operating plan.

23 And ultimately, what it comes down to to 24 a company like ours is predictability. Sufficient 25 granularity in schedules so we know what's next, how NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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153 1 do we assess that each one of those milestones whether 2 it's on track or off track, and our ability to predict 3 those next steps, manage accountability, manage 4 schedule, manage budgets.

5 The risk to any business, the biggest risk 6 to any business is uncertainty. And we've been in an 7 uncertain environment. And this meeting succeeded in 8 helping to remove some of the uncertainty in terms of 9 establishing a framework where we can now discuss the 10 schedule.

11 And a number of the elements are going to 12 obviously fall right back on us. We have better 13 expectations of what the standard is by which we need 14 to meet. But I think we also can establish a program 15 management plan so we collectively understand when a 16 milestone's been achieved and what the next milestone 17 that we all need to focus on.

18 MR. BALAZIK: And if there are no more, 19 this is Mike Balazik, again. If there are no more 20 questions in the room, first of all I guess I would 21 like to ask if there's any NRC staff on the phone that 22 has any questions. And then we'll open it up to the 23 public.

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154 1 from the NRC staff, so now I would like to open up the 2 phone lines to the public for public comment. Just a 3 couple of items.

4 Please, speak one at a time and identify 5 yourself in speaking. And also if you're 6 uncomfortable asking a question on the phone, you can 7 submit your question to me via email at mfb@nrc.gov.

8 Are there any public comments?

9 (No audible response) 10 MR. ADAMS: Can someone verify that the 11 phones are still open and working?

12 PARTICIPANT: Yes, the phones are open.

13 MR. ADAMS: All right, we just want to 14 make sure silence wasn't something unplugged 15 somewhere.

16 MR. LYNCH: Thanks, Jenny.

17 PARTICIPANT: We're here, thank you.

18 MR. BALAZIK: All right. So I think we 19 are, are we expecting Bill and others to join us 20 later?

21 MS. GAVRILAS: Yes. I think we'll adjourn 22 until 2:30 when we have an opportunity to interact 23 with two office directors. I think at least one 24 office director, perhaps two. And certainly my boss, 25 Lawrence Kokajko is going to join us.

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155 1 I don't know if Craig who is the acting 2 director in Shana's organization is also going to join 3 us. So you'll have an opportunity to reiterate, we'll 4 reiterate our action items and you'll have an 5 opportunity to interact with them.

6 MS. HAASS: And which office directors, 7 potentially?

8 MS. HELTON: Bill Dean.

9 MS. GAVRILAS: Bill Dean, our director is 10 coming for sure.

11 MS. HAASS: Okay.

12 MS. GAVRILAS: And his deputy might come 13 as well.

14 MR. ADAMS: So we're going to go mute on 15 the phones until 2:30 and then we'll be back on.

16 (Whereupon, the above-entitled matter went 17 off the record at 1:54 p.m. and resumed at 2:33 p.m.)

18 MR. BALAZIK: Mike Balazik, we're resuming 19 the public meeting. Right now we're toward the end of 20 the meeting. And we just want to real quickly go 21 through some closing remarks. Oh, I'm sorry.

22 Bill Dean, Office Director of NRR is 23 joining us, and Michele Evans has also joined us, and 24 Lawrence Kokajko has also joined is. He's the 25 Director of DPR, for our members on the phone. All NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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156 1 right.

2 (Off microphone comments) 3 MR. BALAZIK: Okay, can we just go through 4 everybody, identify themself that's new to the 5 meeting?

6 (Simultaneous speaking) 7 MS. EVANS: Sure. Michele Evans, Deputy 8 Director of NRR.

9 MR. KOKAJKO: Lawrence Kokajko, Division 10 Director, Division of Policy and Rulemaking.

11 MS. MARSHALL: Jane Marshall, Deputy 12 Director, Division of License Renewal, NRR.

13 MR. ERLANGER: Craig Erlanger, Acting 14 Director for the Division of Fuel Cycle Safety 15 Safeguards and Environmental Review.

16 (Off microphone comments) 17 MR. BALAZIK: Okay. You want to start?

18 MS. GAVRILAS: Yes, so we had what I would 19 qualify as a productive meeting this morning. And I'm 20 going to ask the Northwest Medical Isotopes to bring 21 their own clarification.

22 Mike and Steve prepared a few summary 23 points of the meeting that I'll ask them to go 24 through, a couple of action items. And then I know 25 that Bill would like to engage you in some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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157 1 discussions. And with that, I'm going to ask Mike to 2 summarize.

3 MR. BALAZIK: You going to go through the 4 points, Steve? You have the points?

5 MR. LYNCH: Whatever you would like.

6 MR. BALAZIK: Yes.

7 MR. LYNCH: I can go through it.

8 MS. GAVRILAS: One of you two needs to do 9 the summary of this morning, please, and the action 10 items. Thank you very much.

11 MR. LYNCH: All right. So I guess for 12 everyone's benefit that's in here that was not here in 13 the morning, we had two main objectives that we had 14 set out to accomplish as identified by Northwest, and 15 those were to talk about the licensing approach for 16 the facility. And then the second item was to talk 17 about mechanisms to expedite the review of Northwest's 18 construction permit application.

19 For the first point, we reached agreement 20 and a shared understanding that there is additional 21 technical information that Northwest will need to 22 provide to meet the Part 70 requirements in 10 CFR.

23 Whether that's submitted as part of their 24 operating license or as a separate application is up 25 to them, but we are in agreement that regardless of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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158 1 how the information is packaged, we understand on both 2 sides what technical information needs to be provided.

3 Is that correct?

4 And then the second point for mechanisms 5 to expedite the review, we went over a number of items 6 that we can do on both sides to make sure that we 7 review their construction permit application as 8 expeditiously as possible.

9 One of the items we discussed were 10 approaches to request for additional information to 11 limit both the total number of RAIs that we asked and 12 the number of rounds that we go through.

13 Ways that we can address that are ensuring 14 that the NRC is clear in the questions that we ask and 15 making sure that we have phone calls with Northwest 16 when those RAIs are issued to make sure they 17 understand the question that we are asking.

18 And also when they are getting prepared to 19 submit their responses, to have additional calls.

20 That may take the form of a public meeting if we need 21 to discuss technical details, or it could be shorter 22 clarification calls to make sure that they're on the 23 right track.

24 Again, the goal of that is to make sure 25 that we have a shared understanding of the NRC's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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159 1 expectations and what Northwest's understanding of our 2 expectations is. We also emphasize that quality and 3 completion of those RAIs is important as well.

4 This fed into a larger discussion of 5 appropriate methods of communication during the review 6 process. We have already established weekly calls 7 following the docketing of the application that Mike 8 and others as needed sit on with Carolyn once a week 9 to discuss the status of the review and then the other 10 administrative details as necessary. And that's 11 consistent with our practices for other reviews 12 throughout the agency.

13 MR. DEAN: So how long has that been going 14 on? For how long?

15 MR. LYNCH: Since January 12th.

16 MR. DEAN: Okay, all right.

17 MR. LYNCH: So right after we concepted 18 the review and everyone got back from the holidays.

19 MR. DEAN: Okay.

20 MR. LYNCH: We discussed the importance of 21 staying up to date on schedule, both from the NRC's 22 perspective as we're doing our review to make sure we 23 communicate how we're progressing towards milestones, 24 and also to get updates from Northwest on 25 anticipations of when, you know, if they have any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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160 1 delays on the current application, responses through 2 RAIs, and just updates of when they anticipate 3 submitting future applications such as their operating 4 license application.

5 We discussed, as far as the information at 6 Northwest provides what's the threshold of what's 7 acceptable to the NRC, we went there already following 8 our formatting content that I had provided in NUREG 9 1537 and the ISG augmenting NUREG 1537.

10 And as far as the threshold that we set 11 for the information that we're doing our review, we 12 told them that when we do our review we use our 13 standard review plan that is publically available, and 14 that is the threshold we set for the information that 15 we are looking for in their application.

16 And to maximize the efficiency of our 17 review, the clearer it is to us that they have 18 addressed the acceptance criteria in the standard 19 review plan, the easier it is for the NRC to move 20 forward quickly.

21 MR. DEAN: Both for the Part 50 and the 22 Part 70 aspects?

23 MR. LYNCH: Yes, yes. We discussed the 24 guidance for both aspects that they can use.

25 MR. DEAN: Okay.

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161 1 MR. LYNCH: We also talked about the 2 importance of reducing administrative time for 3 processing on the NRC side and also preparation of 4 documents on Northwest's side. The goal is through 5 our talks to make sure that there isn't significant 6 debt time where either side is sitting, not doing 7 anything and just waiting.

8 And this feeds into general program and 9 project management on both sides and making sure that 10 we are identifying clear goals towards working towards 11 the identified milestones that we have in the project.

12 And the last thing that we went over, or 13 I shouldn't say last thing, I could think of two more 14 things. Looking at past precedents, we have examples 15 of reviews we have done in the past, most recently 16 with SHINE, there are transcripts available from ACRS 17 meetings that they can look through as we go through 18 ACRS to help improve their preparation for those 19 meetings.

20 Also, they can get a sense from looking at 21 these applications for what the NRC has found 22 acceptable in the past and types of RAIs we've asked 23 in the past and what types of responses we're looking 24 for and similarity of reviews.

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162 1 license application, one way we can get ready for that 2 is we explore the possibility of having pre-3 application meetings to discuss the technical problems 4 or issues that may come up that we need to explore 5 before the application is submitted that there may be 6 questions on.

7 And also with the current construction 8 permit application, we talked about efficiencies that 9 can be gained from maintaining that document up to 10 date as they respond to RAIs and information in their 11 current PSAR needs to be updated, that they can 12 provide updates to that.

13 At times it will work out with Mike, it 14 will make it easier for our reviewers to have a single 15 document to look at that has all of the updated and 16 completed information, and also as we go forward to 17 the ACRS and with the mandatory hearing.

18 We also discussed earlier today the status 19 of our review and our plans going forward. So with 20 all of that, I think with that I think with those 21 topics, that addressed the second main point of 22 talking about ways that we could expedite the review.

23 I think that covers it for that second point.

24 MR. FOWLER: You did a good job, thank 25 you.

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163 1 MR. LYNCH: And then between 1:30 and 2:00 2 we came up with a list of action items to take away to 3 come back to in the future. The first of these was 4 setting up a, exploring the possibility of setting up 5 standing public meetings.

6 And this, Mike and Northwest will work 7 together on this to see if it's needed. But the idea 8 behind this is to cut down on some of that 9 administrative time.

10 If we see the need to discuss significant 11 technical information, most likely related to RAIs on 12 a regular basis, instead of noticing public meetings 13 every time we need to have one, we set up a frequency 14 maybe once a month, once every other month, something 15 that's agreed upon between both parties. That was 16 identified as a topic worth exploring in the future to 17 see if it could help in the review.

18 The next action item we had was in a 19 future meeting discuss when the final design for 20 Northwest will be provided to the NRC. This includes, 21 you know, the final design could be submitted as part 22 of the operating license application, or it could be 23 submitted while we are still reviewing the 24 construction permit.

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164 1 help us in our preparations. And then on our side of 2 that, we can discuss with them in the future the 3 impact of their decision to go forward one way or 4 another, without recommending a preference.

5 The third item that I had here was the NRC 6 could benefit also from understanding any additional 7 licensing actions that Northwest may request in the 8 future.

9 This could be related to transportation of 10 materials, any exemptions that they foresee needing 11 for their current licensing requests or future 12 licensing requests. Also, license amendments that 13 existing research reactors might need in order to 14 support the radiations of their manufacture targets.

15 Fourth item that we had as a take-away was 16 making sure that we have clear expectations on both 17 sides. This has to do with, mostly with requests for 18 additional information.

19 Northwest would like to be able to review 20 drafts of the RAIs for potential proprietary 21 information before they're issued. And also to the 22 extent practicable, we would like notifications of 23 when the RAIs are getting close to being issued so 24 that they can make sure that their resources are ready 25 to receive any begin working on responses to them.

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165 1 Also, Northwest offered that for future 2 public meetings, that we have it out in Missouri, that 3 the local government there is willing to work with us 4 in getting that set up in the future as well.

5 And I think the last thing, the last 6 action item I had on here was on both sides, and it's 7 kind of relates to everything else we've just been 8 talking about is just having clear communications on 9 both sides of schedule, NRC making sure that we 10 identify the milestones that we're working towards and 11 our progress towards that and Northwest, again letting 12 us know their schedule and any impacts they may have.

13 MR. DEAN: Okay, is that it?

14 MR. LYNCH: Yes.

15 MR. DEAN: Okay. Good. Sounds like you 16 guys had a productive meeting. So appreciate you guys 17 coming here from Oregon? Both of you from Oregon?

18 MS. HAASS: The northwest.

19 MR. DEAN: Northwest? Okay. Go Ducks.

20 No?

21 MR. FOWLER: Well, we have Ducks and 22 Beavers.

23 MR. DEAN: Okay, all right. Depends what 24 part.

25 MS. HAASS: I'm a Husky.

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166 1 MR. DEAN: Okay, depends on what part of 2 the state that you're from. Well, so I appreciate you 3 guys coming in. And it sounds like it was very 4 productive and useful meeting.

5 I know that you all were here not too long 6 ago and had expressed some concerns with some of our 7 commissioners and some of our senior management about 8 the process and not having a good understanding of the 9 process.

10 And so it sounds like, and I certainly 11 would be interested in your all's perspective that 12 today's meeting helped move us forward in terms of 13 establishing better communication and better 14 understanding of what you can expect from us, but also 15 things that we hope that we can engender from your 16 side of it because I view, personally I view this 17 process, and it's a big deal right, moly-99 is a big 18 deal for this country.

19 And so you guys are pursuing something 20 that is important to public health and safety which is 21 obviously the ultimate mission or objective of the 22 NRC, that we do it in a collaborative way and not in 23 any sort of adversarial way.

24 I know there's always just sort of dynamic 25 in terms of a licensee or an applicant and the NRC and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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167 1 we ask a bunch of questions, you got to give us a 2 bunch of answers.

3 But in reality, I think we're all striving 4 to get to the same point which is can we get licensed 5 for construction and utilization a facility that can 6 be useful in providing moly-99.

7 So in that regard, I think what we have is 8 a very common end point. So I guess I would be 9 interested in your all's perspective in terms of how 10 you thought today's discussion went, were we able to 11 address perhaps some of the concerns you've had in the 12 past.

13 And if there's still some open questions, 14 you know, Steve went through a list of action items, 15 but are there still some things that you all have in 16 your mind that are kind of open or areas that we ought 17 to consider.

18 Like, one thing I didn't hear in your 19 discussion was the benefit of, you know, sometimes 20 when we get an RAI process there's this kind of 21 throwing stuff over the transom and then you all 22 develop and throw it back over the transom.

23 And sometimes we can make better progress 24 if we do things like, well we call them audits, right, 25 but we actually either send people to wherever the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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168 1 information is and have face to face meetings as 2 opposed to going into a sort of a writing campaign.

3 Is that something you guys talked about was the audit 4 process?

5 MR. LYNCH: We did not talk about that 6 today. But we have had an audit on the environmental 7 side as they were preparing information.

8 MR. DEAN: Okay.

9 MR. LYNCH: So we have gone through that.

10 MS. HAASS: And we've had the discussions 11 in the past and we know that it's one of the tools we 12 can use to make things more efficient.

13 MR. DEAN: Okay. Okay, good. Okay, and 14 then the other one was I didn't hear anything about 15 would it be beneficial for example to set up an 16 electronic reading room where you guys have materials 17 that you developed that are accessible to our staff 18 through some sort of portal or whatever so there's 19 more ready actions instead of you guys having to mail 20 them.

21 MS. HAASS: Well, and we are setting that 22 up. There's always technical difficulties because you 23 guys have some requirements and you know what they 24 are, you know, about the encryption and the passwords 25 and this, that, and the other. And so those things NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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169 1 are getting set up.

2 MR. DEAN: Okay. I think we've had some 3 success where the licensee sort of maintains that and 4 then we just get a password for access and it helps 5 maybe avoid some of those, you know, red tape things 6 that we tend to have as a bureaucracy.

7 But anyway, so we certainly, that would be 8 something that could hopefully improve or increase 9 efficiency.

10 MS. HAASS: Well, and another thing that 11 could help efficiencies is I know we talked about it 12 a bit offline just standing here. But, you know, some 13 granularity on how, what RAIs are going to be coming 14 because you're not going to throw all of them over at 15 once.

16 You may be doing them based on subject 17 matter areas and, you know, getting a better 18 granularity in a schedule like that because that helps 19 both your resources and ours and us to be more 20 efficient in responding as well.

21 MR. DEAN: So I was pleased to hear that 22 you guys have set up weekly calls. So hopefully 23 you're finding those beneficial. I know that we do in 24 terms of being able to ferret out those sort of 25 things.

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170 1 And I don't know whether, have you guys 2 kind of developed sort of a standing agenda, or has it 3 kind of been sort of ad hoc? I would assume that 4 there's things that week to week that you're going to 5 want to talk about.

6 MS. HAASS: Yes, there's definitely a 7 standing agenda. But then, you know, you've got 8 things come on and off that agenda as well.

9 MR. BALAZIK: And this is Mike Balazik.

10 And sometimes we'll share stuff earlier in the week 11 that is to be a great topic to have on that weekly 12 call so that we can take one level deeper into it if 13 it's just Kevin and I talking. Sometimes we'll move 14 stuff on a weekly call.

15 MR. DEAN: And also to make sure we get 16 the right people there.

17 MR. BALAZIK: Correct.

18 MR. DEAN: Okay, all right. So that's 19 good. I think that's a great initiative to do that.

20 So at least what I'm hearing was that it was a 21 constructive, worthwhile meeting, is that --

22 MR. FOWLER: I do believe it was a very 23 productive meeting. And for those of you who attended 24 our meeting about a month ago in the Executive 25 Director's office, we understand that the NRC has a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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171 1 mission for public health and takes the production 2 capability this country for moly-99 very seriously.

3 We understand that, appreciate that, 4 respect that. I hope that you all also understand 5 that we take our mission of providing that secure, 6 reliable supply of moly-99 in the United States 7 extremely seriously. That was part of the intent with 8 the Executive Director's office when we were there.

9 We also wanted to communicate that while 10 we all know that this is a public health potential 11 issue, sometimes hearing directly from the feet on the 12 street, the constituents and our supporters and 13 investors are public healthcare institutions serving 14 tens of millions of people across the United States.

15 And so to hear directly from the CEOs of 16 those public health services organizations I think is 17 important to remind us of just how real the mission 18 that we share collaboratively really is. It's 19 extremely important.

20 This meeting stemmed as a follow up to a 21 couple of outstanding items from the initial meeting, 22 the first being clarification on our licensing 23 application submission process. And that one, declare 24 victory.

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172 1 all, I think, are in agreement that we understand 2 where to go from here. We will need to telegraph our 3 approach so that the NRC can anticipate. But we're 4 all on common understanding of that first objective.

5 So declare success on that one.

6 The much broader one is how do we meet the 7 needs of this country in a timely fashion. And what 8 we achieved today was establishment of a very strong 9 framework that we now understand better how the 10 schedule of review is constructed and built within the 11 NRC.

12 That helps tremendously because we can 13 look at the assumptions, we can compare the 14 assumptions, and we can begin to manage this as a 15 project. It's likely, in fact it's assured, that 16 we'll need a number of follow up conversations to 17 translate that framework into a plan that can be 18 project managed, and we've left with a joint objective 19 to do exactly that.

20 And Steve did a great job of summarizing 21 some of those actions. And so we can't yet close with 22 full success the second objective on accelerate the 23 schedule to degree possible.

24 I think we have a pathway to continue a 25 process to get to a mutually agreed schedule, one that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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173 1 we can both bring back to our supporters and manage 2 against with expectations, identify milestones, 3 identify where we've deviated from milestones, and 4 take remedial actions as appropriate.

5 And that, to me, is a successful day spent 6 here in the DC area.

7 MR. DEAN: Well good, I'm pleased to hear 8 that, Nick, in terms of your perspective on how the 9 meeting went because certainly this was one that I 10 felt was very important, you know, the fact that 11 Michele and I and Lawrence wanted to make sure that we 12 touched base with you all before you left to make sure 13 that the meeting met your objective was very important 14 to us.

15 And so that gives me great confidence that 16 we did have a constructive and productive dialogue.

17 But we need to sustain that.

18 MR. FOWLER: Exactly right.

19 MR. DEAN: And I like some of the things 20 you guys have talked about in terms of potential 21 action items. I was interested a little bit more in 22 exploring the topic that Steve raised that when we 23 have meetings in Missouri and the engagement of the 24 local government.

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174 1 we trying to achieve with that. That's a good thing, 2 but I mean --

3 MR. FOWLER: That was in specific 4 reference to any ongoing environmental public meeting 5 needs where we've had one meeting in Columbia already.

6 If there were needs for others, the City of Columbia 7 and the County of Boone County in Missouri have 8 offered any and all assistance to the NRC if any is 9 requested.

10 MR. DEAN: Okay.

11 MR. FOWLER: They stand ready to help.

12 MR. DEAN: Okay.

13 MR. LYNCH: And this is consistent with 14 previous reviews, even for the SHINE review we've gone 15 out for the environmental meetings generally, send an 16 email to the city manager and county executives, let 17 them know we're coming, offer any government-18 government interaction they would like to better 19 understand our process and work our way forward.

20 MR. DEAN: Okay.

21 MR. LYNCH: So that's all consistent.

22 MR. DEAN: Okay. Good, okay. Good.

23 MS. HAASS: And there's also the ability 24 that they would help you coordinate to make things 25 easier, you know, on you. They have the facilities NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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175 1 available.

2 MR. DEAN: That's great.

3 MS. HAASS: And so, and they want to be 4 involved.

5 MR. DEAN: Super. Okay, that's wonderful.

6 Okay, good. Okay. Anything for me that you would 7 like to convey beyond what you already have?

8 MR. FOWLER: Well I think that again, 9 we've had a successful meeting. I think in other 10 strategic partnerships that are collaborative in 11 business that I run, we have not only program 12 management at the level of checking all the boxes on 13 the program plan, we have a refreshment at this level 14 to ensure that both parties are in fact comfortable 15 with progress and resource assignments and strategic 16 alignment as we move forward.

17 Certainly it doesn't need to be a monthly 18 meeting at this level, but probably on a quarterly or 19 semi-annual basis it would make sense for us to touch 20 base at this level to ensure that we're both meeting 21 each other's expectations of moving forward.

22 MR. DEAN: Okay. And you're comfortable 23 with the 12 to 15 to 1 ratio of members of the NRC?

24 Is that okay? You're comfortable with that ratio?

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176 1 we'll reverse the ratio.

2 MR. DEAN: Good, good. Well, anything 3 else that you would like to achieve today?

4 MS. GAVRILAS: No. I think we met their 5 objectives and we have a good meeting.

6 MR. DEAN: Okay, good. Good. All right, 7 so who do I point to in terms of is it Mike is the 8 sort of individual that I want to point to as 9 somebody, for SHINE I went to Steve a lot. So is 10 Mike?

11 MS. GAVRILAS: So that was one of the 12 issues we discussed that even though there are 13 multiple organizations involved in the review, there 14 will be one voice for the NRC and that voice is Mike.

15 MR. DEAN: Okay, good. Okay, good.

16 Super. Okay, anything else? Excellent. Okay.

17 MR. FOWLER: Finished the agenda on time.

18 MR. DEAN: Safe travels. Safe travels 19 back.

20 MR. BALAZIK: This is Mike Balazik. I 21 just want to thank everybody for attending the meeting 22 today. And we're going to close the bridge line.

23 Thank you.

24 (Whereupon, the meeting in the above-25 entitled matter was concluded at 2:58 p.m.)

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Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

Meeting with Northwest Medical Isotopes Docket Number: 50-609 Location: Rockville, Maryland Date: Thursday, February 18, 2016 Work Order No.: NRC-2177 Pages 1-176 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 (202) 234-4433

1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 + + + + +

4 PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC 5 + + + + +

6 THURSDAY, 7 FEBRUARY 18, 2016 8 + + + + +

9 ROCKVILLE, MARYLAND 10 + + + + +

11 The Public Meeting commenced in Room O-12 16B4, One White Flint North, 11555 Rockville Pike, at 13 8:30 a.m., Mike Balazik, Project Manager, presiding.

14 15 NRC STAFF PRESENT:

16 LAWRENCE KOKAJKO, Director, Division of Policy and 17 Rulemaking, Office of Nuclear Reactor 18 Regulation 19 WILLIAM DEAN, Regional Administrator, Region I 20 CRAIG ERLANGER, Acting Director, Division of Fuel 21 Cycle Safety, Safeguards, & Environmental 22 Review, Office of Nuclear Material Safety and 23 Safeguards 24 MICHELE EVANS, Deputy Director, Office of Nuclear 25 Reactor Regulation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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2 1 JANE MARSHALL, Deputy Director, Division of License 2 Renewal, Office of Nuclear Reactor Regulation 3 MICHAEL BALAZIK, Project Manager, Division of Policy 4 and Rulemaking, Office of Nuclear Reactor 5 Regulation 6 ALEXANDER ADAMS, Chief, Research and Test Reactors 7 Licensing, Office of Nuclear Reactor 8 Regulation 9 MIRELA GAVRILAS, Deputy Director, Division of Policy 10 and Rulemaking, Office of Nuclear Reactor 11 Regulation 12 SHANA HELTON, Acting Deputy Division Director, 13 Division of Fuel Cycle Safety, Safeguards &

14 Environmental Review, Office of Nuclear 15 Material Safety and Safeguards 16 ROBERT JOHNSON, Chief, Fuel Manufacturing Branch, 17 Office of Nuclear Material Safety and 18 Safeguards 19 STEVE LYNCH, Project Manager, Research and Test 20 Reactors Licensing Branch, Office of Nuclear 21 Reactor Regulation 22 NANCY MARTINEZ, Environmental Project Manager, 23 Office of Nuclear Reactor Regulation 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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3 1 DAVE TIKTINSKY, Project Manager, Fuel Manufacturing 2 Branch, Office of Nuclear Material Safety and 3 Safeguards 4

5 ALSO PRESENT:

6 NICHOLAS FOWLER, Chief Executive Officer, NWMI 7 CAROLYN HAASS, Chief Operating Officer, NWMI 8

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4 1 T-A-B-L-E O-F C-O-N-T-E-N-T-S 2 Page 3 Opening Remarks by NRC Staff 4 Michael Balazik . . . . . . . . . . . . . . 6 5 Mirela Gavrilas . . . . . . . . . . . . . . 13 6 Shana Helton . . . . . . . . . . . . . . . 14 7 Opening Remarks by Northwest Medical Isotopes 8 Nicholas Fowler . . . . . . . . . . . . . . 15 9 NRC Licensing Processes 10 10 CFR Part 50, General 11 Steve Lynch . . . . . . . . . . . . . . . . 20 12 10 CFR Part 51, Environmental 13 Nancy Martinez . . . . . . . . . . . . . . 36 14 10 CFR Part 50, Construction & Operating License 15 Steve Lynch . . . . . . . . . . . . . . . . 42 16 NRC Licensing Process, Part 70 17 Dave Tiktinsky . . . . . . . . . . . . . . 90 18 Licensing Review Request (NWMI licensing request and 19 NRC understanding of request - NRC/NWMI) 20 Al Adams . . . . . . . . . . . . . . . . 113 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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5 1 Communications (NRC/NWMI) 2 Michael Balazik . . . . . . . . . . . . . 126 3 Steve Lynch . . . . . . . . . . . . . . . 130 4 Al Adams . . . . . . . . . . . . . . . . 134 5 Dave Tiktinsky . . . . . . . . . . . . . 135 6 NWMI Topics for Discussion . . . . . . . . . . 141 7 Closing Remarks/Summary . . . . . . . . . . . . 155 8 Adjourned . . . . . . . . . . . . . . . . . . . 176 9

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6 1 P-R-O-C-E-E-D-I-N-G-S 2 (8:33 a.m.)

3 MR. BALAZIK: All right, good morning.

4 I'd like welcome everyone in attendance today. My 5 name is Mike Balazik. I'm a project manager in the 6 Division of Policy and Rulemaking at the NRC.

7 Northwest Medical Isotopes has agreed to 8 meet with the NRC staff today to discuss licensing for 9 their radio isotope facility.

10 This is a Category 1 public meeting 11 conducted in accordance with the Commission's Police 12 Statement on enhancing public participation in NRC 13 meetings. As such is intended to be a dialogue 14 between the NRC and Northwest Medical Isotopes 15 concerning topics related to licensing in Northwest 16 Medical Isotope facility project.

17 The public in invited to observe the 18 meeting and will have the opportunity to communicate 19 with the NRC staff after the business portion of the 20 meeting, but before the meeting is adjourned.

21 Northwest may respond to comments or questions from 22 the public but is not obligated to do so.

23 When we go through the introductions I ask 24 everybody identify yourself and your affiliation.

25 There's a sign-in sheet that may be moving around the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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7 1 room right now. I ask everyone sign in. Yes, thank 2 you.

3 If you wish to provide any comments on the 4 meeting, I can provide you a meeting feedback form.

5 Or you can also go to the public meeting cite and do 6 it electronically.

7 This meeting is scheduled to last till 8 approximately 3:00 p.m. I'd like to emphasize that 9 this meeting is primary for the NRC to discuss general 10 licensing processes and reviews, the NRC regulations 11 and guidance with the Northwest. There are no 12 regulatory decisions will be made at this meeting.

13 Also, as a reminder, this meeting is being 14 transcribed today. And for everybody on the phone, 15 the slide presentation is available. It's publically 16 available. And I'm going to provide the NO number 17 right now for everyone. The number is ML16048A, as in 18 Alpha, 554.

19 Does anybody on the phone need that 20 repeated? All right, I'm not hearing any.

21 (Off record comment) 22 MR. BALAZIK: All right, I'll continue on.

23 A meeting summary will be made publically available 24 within 30 days of this meeting.

25 Before we begin, a couple of items I'd NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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8 1 like to mention. First of all, please limit 2 interruptions. Silence your cell phone and please 3 keep side conversations to a minimum.

4 I ask you speak one at a time. And 5 individuals on the phone, please mute your phone 6 unless you're going to provide any comment.

7 Also, please identify yourself when you 8 speak so people on the phone knows who's speaking.

9 And again, submit any questions or comments to me at 10 mfb@nrc.gov.

11 Next I'd like to remind you that you're 12 within a NRC controlled space. Should there be an 13 emergency all occupants should begin to calmly 14 evacuate using the nearest stairwell to exit the 15 building.

16 All visitors will be escorted by the NRC 17 staff. Disables persons, who due to health reasons 18 feel they cannot safety walk down the stairs to 19 evacuate, may use the elevators. Exit through the 20 nearest door and then go to the pause area in front of 21 One White Flint and report their presence with the 22 guard.

23 So you experience, observe anyone with a 24 life threatening medical complaint while evacuating, 25 call 911 and report your location and nature of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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9 1 emergency.

2 Also, if you need to use the restroom, 3 you'll need to be escorted.

4 All right. So let's now run though 5 introductions. I'd ask everyone to speak loudly so 6 people on the phone can here you. And let's start 7 around the table.

8 As I said earlier, my name is Mike 9 Balazik. I'm a Project Manager in Division of Policy 10 and Rulemaking.

11 MS. MARTINEZ: Good morning. I'm Nancy 12 Martinez, NRC Environmental Project Manager.

13 MS. GAVRILAS: Mirela Gavrilas, Deputy 14 Director, Division of Policy and Rulemaking in NRR at 15 the NRC.

16 MR. LYNCH: This is Steve Lynch. I'm a 17 Project Manager with Research and Test Reactors.

18 And real quick, before we go on with the 19 introductions, if you are participating on the phone, 20 could you please put your phone on mute? We're 21 getting a lot of feedback in the room here. Thank 22 you.

23 MR. ADAMS: Al Adams, Chief of Research 24 and Test Reactor Licensing, NRC.

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10 1 Manager of the Field Manufacturing Branch in Office of 2 Nuclear Material Safety and Safeguards.

3 MR. JOHNSON: Good morning. Robert 4 Johnson, Fuel Manufacturing Branch Chief, NMSS.

5 MS. HELTON: Shana Helton, Acting Deputy 6 Division Director at Fuel Cycle NMSS.

7 MR. FOWLER: Nick Fowler, the Chief 8 Executive Officer of Northwest Medical Isotopes.

9 MS. HAASS: Carolyn Haass, Chief Operating 10 Office, Northwest Medical Isotopes.

11 MS. KEIM: Andrea Keim, Vendor Inspection 12 and Quality Assurance, NRR.

13 MR. MATULA: Tom Matula, NMSS, Project 14 Manager.

15 MR. MORRISSEY: Kevin Morrissey, Fuel 16 Cycle Review.

17 MS. ADAMS: Mary Adams, Fuel Cycle Safety 18 and Environmental Review.

19 MS. LONDON: Lisa London, Office of 20 General Counsel.

21 MS. BIELECKI: Jessica Bielecki, Office of 22 General Counsel.

23 MR. LINDELL: Joseph Lindell, Office of 24 General Counsel.

25 MS. KANATAS: Catherine Kanatas, Office of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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11 1 General Counsel.

2 MS. YOUNG: Mitzi Young, Office of the 3 General Counsel.

4 MS. TRAN: Linh Tran, Research and Test 5 Reactor Licensing Branch, NRC.

6 MR. ALLEN: Eben Allen, Research and Test 7 Reactor, Project Manager.

8 MR. BALAZIK: This is Mike Balazik, please 9 mute your phones. Somebody's got an open line and 10 they're speaking and we're hearing you in the room.

11 MR. LYNCH: Star 6.

12 MR. DANNA: Jim Danna, NRR, Division of 13 License Renewal.

14 MR. MILLER: Chris Miller, Office of 15 Nuclear Reactor Regulation. And I'm the Director of 16 the Division of License Group.

17 MR. ISAAC: Patrick Isaac, Research 18 Reactor Oversight Branch.

19 MR. BALAZIK: All right, this is Mike 20 Balazik again. Let's go to the phone line. I ask 21 individuals to identify themselves.

22 MR. RODRIGUEZ: Michael Rodriguez, NRC, 23 NSIR EP.

24 MR. FLAGG: Michael Flagg, University of 25 Missouri Research Reactor.

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12 1 MS. MCCULLOUGH: Kara McCullough, NSIR, 2 NRLB.

3 MR. BERICK: Dave Berick with Senator Ron 4 Wyden.

5 MS. RIVERA: Alison Rivera, NSIR EP.

6 MS. BANERJEE: Good morning. Maitri 7 Banerjee, ACRS Staff.

8 MS. WEIL: Jenny Weil, Congressional 9 Affairs.

10 MS. FRAZIER: Andy Frazier, Region III 11 Office.

12 MS. MOSER: Michelle Moser, Environmental 13 Energy Staff.

14 MR. BARTELME: Jeff Bartelme, SHINE 15 Medical Technologies.

16 MR. NAQUIN: Ty Naquin, NMSS, Fuel 17 Manufacturing Branch.

18 MR. TEAL: Charles Teal, NSIR Fuel Cycle 19 Transportation Security Branch.

20 MR. FOLK: Kevin Folk, NRC Environmental 21 Staff.

22 MR. WEBER: Carl Weber, NRC, Office of New 23 Reactors.

24 MR. BALAZIK: Is there anybody else on the 25 phone that wishes to identify themselves? Okay, I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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13 1 hearing none.

2 So now I'd like to turn it over to Mirela, 3 who would like to provide some opening remarks.

4 MS. GAVRILAS: Thank you, Mike. Welcome 5 everyone. I want to start out with a very high level 6 statement which is, that we, the Agency, recognize the 7 importance of establishing a reliable domestic supply 8 of molybdenum-99.

9 And as such, we recognize our role to 10 support that national effort. So you will see, you 11 will hear today about what we do and how we do it and 12 why we do it.

13 And you'll also hear, you see already that 14 the room is filled with technical experts and with 15 regulatory experts who are here to answer all your 16 questions. Because the main objective of this meeting 17 is to obtain clarity in our communications.

18 It is very important to us that we hear 19 each other correctly. Because we realize that every 20 time we take time out to clear out misunderstanding, 21 we spent resources and time that would be better spent 22 moving the review and the effort forward.

23 So our main objective today is basically 24 to discuss the topics that we agreed with Northwest 25 Medical, should be discussed today. And we want to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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14 1 have open dialogue. So please ask questions at any 2 time.

3 Again, we have the technical and the 4 regulatory experts in the room to address your 5 questions. So we want to make sure that at the end of 6 the meeting, we're aligned in terms of our 7 understanding of where we are in terms of the review 8 of the construction permit that's in front of us now, 9 as well we the preview of the operating license that 10 is still to come.

11 So with that, I'm going to pass it to 12 Shana who is going to give a couple of additional 13 opening remarks.

14 MS. HELTON: Thanks, Mirela. I agree with 15 Mirela's points. I can't emphasize enough the need to 16 obtain clarity on both sides, so that we can have an 17 efficient, effective licensing path forward.

18 And to that end, I just want to say, that 19 while multiple offices are involved with this review, 20 we do act as one NRC. You will hear from us with one 21 voice.

22 Mike Balazik will be your primary point of 23 contact. So you don't have to worry about trying to 24 correlate between different offices.

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15 1 that I wanted to emphasize is that for each 2 application that we receive as an Agency, not just in 3 this area of medical isotopes, we review each 4 application based on its merits.

5 So really we need to look at what's before 6 us today. And as we go through the construction 7 permit, that will be one aspect of the review.

8 One goal, on our end, is to really gain 9 clarity on the nature of any of your future 10 submittals, since you've indicated that some of your 11 activities would be regulated under Part 70 and under 12 Part 30. So I look forward to learning more about 13 that path forward as well.

14 So with that, you know, I just look 15 forward to having a good meeting. Thank you for 16 coming here today. And for everybody on the phone.

17 MR. BALAZIK: This is Mike Balazik. Thank 18 you, Shana. Now I'll turn it over to Northwest 19 Medical Isotopes for some opening remarks.

20 MR. FOWLER: Well, and I would add my 21 thanks to everyone that's assembled here. In that we 22 all understand the importance of serving a reliable 23 and secure supply within the United States for moly-24 99.

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16 1 his direct staff and a number of folks who are in this 2 room a month ago. And we believe, Northwest Medical 3 Isotopes believe, it was an excellent conversation.

4 Part of a long-term relationship building exercise to 5 make these conversations as productive as possible.

6 We invited with us, a couple of people to 7 provide perspective. One of whom was the chief 8 executive officer of a leading healthcare services 9 provider in the United States.

10 And we all recognize the need for this 11 reliable supply of moly in the United States. But 12 sometimes hearing it from a healthcare services 13 provider that's responsible for millions of people, 14 who can provide that direct testimony of what it means 15 when there are shortages, is important. And we 16 thought that important to provide that direct 17 perspective into the executive meeting a month ago.

18 We also invited Mallinckrodt to speak on 19 the state of the supply chain. And what is coming 20 forward in the near future and the potential fragility 21 of that supply chain that really puts a point on why 22 these activities that are before the NRC are so 23 important.

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17 1 specifically. And we hope that this meeting today 2 directly addresses those two questions as follow up to 3 that meeting.

4 The first had to do with the licensing 5 approach as our activities do incorporate both Part 50 6 and Part 70 activity in our intended operations.

7 And the other was recognizing the need for 8 this domestic supply, exploring mechanisms by which 9 the review schedule can be accelerated, expedited, 10 done in the most productive fashion possible.

11 And we are committed to not only 12 understanding the process of the NRC and being 13 extremely responsive to that process, but also doing 14 everything we can possibly do to make that review as 15 expeditious as possible. And we hope to have that 16 kind of conversation today to understand how we might 17 work better together to get the review done and as 18 quickly as possible, without compromising our combined 19 committee to public safety, as well as public health.

20 And so I did have the opportunity on the 21 nine hour trip yesterday, in the care of one of our 22 major airlines, to review the materials that Mike had 23 provided to Carolyn in advance.

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18 1 educational standpoint. I think we understand largely 2 the background.

3 And so perhaps going through the general 4 information as quickly as possible, and getting 5 specifically more to those two follow up items, could 6 save us all some time. Because we have reviewed all 7 the guidance from the NRC. We've reviewed the general 8 information.

9 And so getting quickly to the areas of 10 combined interest is certainly our objective here.

11 So, Michael, thank you very much for providing the 12 materials early.

13 And with that, I'd like to turn it back to 14 the NRC to begin this, what we all hope, to be a very 15 productive meeting.

16 MR. BALAZIK: Thank you, Nicholas, I 17 appreciate that.

18 MS. GAVRILAS: So just one comment. The 19 slides that you have, we really appreciated the fact 20 that you reviewed them before we're going to talk 21 about them.

22 They're intended to engage you in dialogue 23 with us. They're intended to basically, we're talking 24 in general, and you may want to take the opportunity 25 to ask, how does this impact us.

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19 1 What we're trying to understand is, not 2 just what your questions are, but why you asked those 3 questions. Because we want to make sure that we're 4 answering, not just the words, but the intent of what 5 you're trying to find out.

6 So again, thank you for going through 7 them, this is great. It seldomly happens. And we'll 8 just use them as context for the rest of the 9 discussion. So please, at any time, just stop us and 10 talk to us about everything. Thanks.

11 MR. BALAZIK: All right, this is Mike 12 Balazik again. First of all, for transcription 13 purposes, please identify yourself prior to speaking.

14 And let's start the presentation.

15 One item that I'd like to add is that no 16 proprietary materials planned to be discussed by this 17 staff during this meeting. However, if Northwest 18 Medical Isotopes believes that we are starting to move 19 in that direction, please let us know so that we can 20 cut off the discussion right there. So thank you.

21 All right, these -- here's the staff 22 that's presenting today. Earlier we've all identified 23 ourselves so we'll go through these slides real quick.

24 Basically this is the meeting purpose.

25 Here's some of the main topics we want to cover today.

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20 1 Just provide a general overview of the NRC, oops, I'm 2 sorry. It skipped one on me.

3 Provide an overview of NRC licensing 4 processes, provide an overview of NRC regulations and 5 guidance for construction permit operating license and 6 a Part 70 license, as well as a 30 license. Discuss 7 review timeline. Provide status of the construction 8 permit application review and discuss communications.

9 Okay?

10 And next we'll go into the licensing.

11 MR. LYNCH: Sure. This is Steve Lynch.

12 And just to give myself a little bit more of an 13 introduction.

14 For those who don't know, I was involved 15 with the SHINE review and was the lead projector 16 manager for that. So I'm helping out with the 17 Northwest review to provide insights and input to help 18 gain efficiencies and lessons learned from previous 19 reviews that we've done. And apply them.

20 And that's what we try doing at the NRC.

21 Is we've done something before, hopefully the next 22 time we do it we can apply the lessons learned from 23 before.

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21 1 and the NRC. We want to emphasis that where we pick 2 the licensing process from the regulations is driven 3 by the technology that's put in front of us.

4 And especially with the medical isotope 5 facilities. Some of the considerations that we look 6 at are, how much material are you going to have, what 7 types of material will be onsite.

8 That will help determine where you fall in 9 the regulations, the activities that you're actually 10 going to be performing with this material.

11 Are you going to be making targets, are 12 you going to be irradiating targets, will you be 13 processing targets. How will you be irradiating your 14 targets. Will you be using a nuclear reactor. Will 15 an accelerator be involved.

16 Then we also look at the, how you're going 17 to be processing the targets afterwards. And the 18 bigger driver for licensing regimes there is, looking 19 at the batch size.

20 As I'm sure you're very well aware, if 21 you're processing batches of greater than 100 grams of 22 special nuclear material, that will put that activity 23 into the Part 50 licensing process.

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22 1 facilities. And as I understand with Northwest, it 2 will be a mixture of both. Using existing research 3 reactors as well as constructing a new facility for 4 processing.

5 Next slide. So once we've looked at all 6 the technology and how you're going to be using the 7 material, the next step is to try putting it into the 8 different boxes we have in our regulations.

9 These are not all of the regulations that 10 you need to follow in order to get a license. But 11 these, in terms of the application that you provided, 12 are some of the main technological boxes that we'll be 13 looking at in terms of licensing the production 14 facility in Part 50.

15 The special nuclear material will be 16 looked at under Part 70. The moly that's produced 17 we'll be looking at under Part 30.

18 And then with all of this, we'll be 19 looking at the environmental impacts of these actions 20 and how the material will be used.

21 Next slide. So we're going to spend today 22 highlighting some of the different processes that we 23 use from that previous slide. Especially focusing on 24 Part 50, for the production facility, Part 70, for 25 material. And then also Part 51 for the environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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23 1 review process.

2 And we just kind of want to step through 3 these processes to see if you have any questions about 4 how we are conducting the review of the application 5 that you've provided us.

6 So we'll get started with an introduction 7 to how we're looking to have a Part 50. In order to 8 go through the Part 50 and licensing process, there 9 are two licenses that you will need to apply for and 10 get from the NRC in order to operate your facility.

11 And that's a construction permit, which 12 you have applied for, and an operating license that we 13 will look forward to reviewing, if you choose to 14 submit one.

15 The main components of the construction 16 permit are the environmental report and the 17 preliminary safety analysis report. You've submitted 18 both of those, so you're familiar with their content.

19 And then for the operating license 20 application, we'll be looking at your final safety 21 analysis report, which includes more information, and 22 was in your PSAR. Including your plans for operation, 23 handling emergencies and your technical 24 specifications.

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24 1 license application will be the Physical Security 2 Plan.

3 Our commitment to doing these reviews, for 4 both the construction permit and the operating 5 license, is to finish these reviews within a year and 6 a half to two years from docketing the application.

7 Based on the experience that we have 8 recently with applications like this, we believe that 9 we can meet that review schedule.

10 Yes, we're going to go into more detail 11 about ways that we can, that factors that may 12 accelerate or hinder our ability to meet this.

13 Next slide. So today we'll focus mostly 14 on the regulations and licensing surrounding 15 construction permits. Since that's the application 16 that we have in-house.

17 If you would like to gain better 18 understanding of the operating license review process, 19 we can certainly discuss that in a future meeting.

20 For here, I wanted to highlight some of 21 the more important regulations concerning the 22 construction permit. This is highlighting the main, 23 you know, 50.22 puts you into the realm of the 24 commercial facility under the Atomic Energy Act.

25 That's Section 103.

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25 1 And as I'm sure you're aware, this is 2 slightly different than most of the other non-power 3 facilities that we license under Part 50. Those are 4 generally research reactors that are non-commercial 5 facilities.

6 And the main difference that we see there 7 is that there will be a mandatory hearing on your 8 application. And there will be a review by the ACRS 9 as well.

10 The other, some of the other things that 11 you're aware of under 50.30, you're to submit an 12 environmental report, which you have done. And submit 13 a preliminary safety analysis report under 50.34, also 14 what you have done.

15 And then some of the other important 16 regulations that you address in your accident analysis 17 are meeting both occupational and public dose 18 requirements under Part 20.

19 All right, then after we finished our 20 review of your application, what the NRC is fighting 21 to come to a conclusion is, can you construct your 22 facility as described in your PSAR?

23 And what we're looking at there are these 24 regulations that I have listed at the end there.

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26 1 slide, as far as the findings that the commission 2 needs to make in order to issue a construction permit.

3 And those are supported also by the findings that are 4 in 50.40, 50.42 and 50.50.

5 Next slide. So as the NRC evaluates your 6 application, these are the primary four findings that 7 we are looking to make, based on the information that 8 you have provided.

9 We'll look at, to see, have you provided 10 the proposed facility design. And the emphasis here 11 is, what we're looking at for is, have you given us 12 your principle design criteria in this first bullet.

13 As you're aware, 50.34(a) does require 14 that you describe your principle design criteria.

15 Unlike nuclear power reactors, the principle design 16 criteria are not enumerated in Appendix A of Part 50.

17 And that you are left to propose your own design 18 criteria per your facility in this case.

19 We also recognize that we are being 20 provided a preliminary design. And as such, there may 21 be information that you have not provided at this 22 time.

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27 1 in order to establish a preliminary design.

2 Something else, 50.34(a)(8) allows ongoing 3 research and development through construction. For 4 those areas that you've identified that you have 5 ongoing research and development, we'll be looking to 6 see that you have a research and development program 7 developed and setup in order to resolve any safety 8 questions associated with those items.

9 And then all this comes down to, that we 10 need reasonable assurance, that prior to the 11 completion of construction, any safety questions that 12 are opened, will be resolved in the interest of public 13 health and safety.

14 Next slide. So this slide, what I wanted 15 to emphasize is the difference between the 16 determinations that we're making at the construction 17 stage and at the operating license stage.

18 At the construction stage, we're 19 essentially only -- we're allowing you to go forward 20 and construct. You've given us enough information for 21 us to say, go ahead and get started.

22 In contrast, when we issue an operating 23 license, this is when we say that, based on the final 24 design of the facility, that we believe it can be 25 operated safety. So I just wanted to emphasize the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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28 1 difference in the emphasis that we place in those two 2 determinations.

3 Next slide. So I'm hoping this slide 4 helps partially answer one of your questions that you 5 had about the licensing process and how we look at 6 your applications and how you can submit them. And 7 we'll go into some more detail on this when we get 8 specific with your application.

9 But both the Atomic Energy Act and the 10 regulations allow for an applicant to combine 11 applications. And this is common.

12 There's, and mostly we'll see this with 13 the operating license application. In order for 14 reactors to operate, they will also require a Part 70 15 license in order to possess and use material on their 16 site.

17 And then following that up, the commission 18 does combine those licenses. So you see, and Al will 19 show you an example of that later today.

20 When reactors are issued licenses, there 21 is typically a Part 70 license. And the Part 30 22 license, and sometimes the Part 40 license that are 23 combined together in that, is on a single piece of 24 paper and a single license.

25 So we are --

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29 1 MR. FOWLER: Can I ask a question at this 2 point?

3 MR. LYNCH: Yes.

4 MR. FOWLER: At the executive director 5 meeting, Mirela, I believe you did a, at least you 6 helped me, and I'll use the, I could use inappropriate 7 terms in the regulatory environment because it's not 8 an environment that I deal with every day, but I 9 understood from your presentation, in that meeting, 10 that we had the choice. That we could submit a 11 separate Part 70 license or we could submit, under the 12 Part 50 umbrella, the Part 70 requirements with the 13 important caveat that the Part 70 information, at that 14 point of submission, needed to be final because it was 15 a one-step process.

16 And so I understood our follow up to be 17 within one week of that meeting, to confirm that 18 understanding to us that we had that option, between 19 those two choices. And, so I think in the interest of 20 time, if we could simply confirm that, that our 21 understanding is compatible with your understanding, 22 I think we're all set.

23 MS. GAVRILAS: What I said at the meeting 24 is still what our position is. And we'll walk you 25 through the slides.

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30 1 This just helps explain the details. The 2 bottom line is, we look at your activities from a 3 safety perspective. And the security perspective.

4 So as long as we -- and our rules and our 5 guidance help us know what we need to evaluate in 6 those activities.

7 So whether the description of how you make 8 your safety case comes on one piece of paper or on two 9 pieces of paper, is not that important. In the end 10 we're going give you one license that captures all of 11 those activities.

12 But the review is going to be, we're going 13 to look at every safety component that we need to and 14 every security component of all the activities that 15 you are proposing.

16 So in other words, it doesn't matter how 17 the information comes in, the regulation is designed 18 to allow us to combine that information into one 19 license. And the regulation does allow us to 20 basically eliminate repetition.

21 So if you provided something in one 22 context, you don't need to resubmit that information, 23 because you do get credit for it under the activity.

24 If the activity was described on one piece of paper, 25 you get credit for it. You don't need to describe it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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31 1 again.

2 MS. HELTON: Mirela, I agree. I just want 3 to make sure that it's clear that the packaging is up 4 to you. How you package it all together, multi 5 submissions, a single submission.

6 What needs to be clear, in your submission 7 or submittals, however you decide to do it is, what 8 regulations you're seeking to comply with. And then 9 you also have to fully demonstrate your compliance 10 with those regulations.

11 So it just has, however you do your 12 packaging, it has to be very clear that if you intend 13 for this information to satisfy Part 70, subpart (h),

14 or whatever you're going to do, that you have to very 15 explicitly.

16 That will help our review greatly if you 17 very explicitly say, this is the information that 18 complies part umptysquat. But, you know, we can't 19 identify that for you, you have to identify what parts 20 of the regulation you need to comply with, and then 21 you have to demonstrate how you comply.

22 MS. GAVRILAS: And to add to what Shana is 23 saying, you can cross reference in all of your 24 document that you submitted.

25 MS. HELTON: Right.

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32 1 MS. GAVRILAS: And right away, that adds 2 to the case that I'm trying to make in this piece of 3 paper.

4 MR. FOWLER: So very simplistically, from 5 my standpoint, again, because I'm not schooled in the 6 art of regulatory review, is the final Part 70 7 information, we can include, either in our operating 8 license under Part 50 application or as a separate 9 Part 70 document, but we need to be clear about what 10 we're submitting under which format.

11 MS. HELTON: Right.

12 MR. FOWLER: So if I have that very high 13 level kind of understanding, that will put it in my 14 brain, Carolyn will take care of the details. But at 15 least now I have it in my brain that the Part 70 is 16 either under an operating license or under a separate 17 Part 70 submission.

18 MR. LYNCH: Yes. And I think what's most 19 important there is, we're looking to make our safety 20 determination based on technical information that you 21 provide.

22 Whether it's Part 50 or Part 70, we still 23 have to say, we have technical requirements that we're 24 trying to make to justify safety. So we're looking 25 for technical information.

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33 1 And when we have all that technical 2 information, we can figure out which box, you know, 3 will it be a full, will it be Part 50 with Part 70 as 4 part of that or separately. But we will evaluate that 5 based on the request that you ask of us.

6 MS. HAAS: We understand the safety 7 aspect. I mean Nick is just trying to bring it up --

8 MR. FOWLER: Yes.

9 MS. HAAS: -- because it's based on 10 conversations we've had over the last two or three 11 years and it got modified within your organization.

12 So we just wanted to make sure that we understood it, 13 and we do. So thank you for the input and we'll move 14 on.

15 MS. GAVRILAS: You know, we start every 16 public meeting with a disclaimer, which is, we're not 17 going to reach regulatory decisions here and there's 18 a reason for that.

19 Everything that the staff reviews needs to 20 be on the docket. I mean that's the tentative of how 21 we operate.

22 So we have dialogue here. So right now, 23 what we have for review in front of us and what we can 24 be very specific on, at least the portions that we've 25 reviewed, is the construction permit. The Part 50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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34 1 construction permit.

2 Anything else is in pre-application space.

3 If that makes sense?

4 So if there is -- if we're sometimes 5 tentative or give you our best opinion, we will 6 clarify. That opinion will become definitive, once we 7 have an application in front of us.

8 It's worth repeating because, again, in 9 the absence of information, all we can do is say what 10 the most likely path is.

11 MR. LYNCH: Okay. Next slide. So what 12 we're going to transition to now is talking a little 13 bit more about the actual review process for the 14 construction permit. And we'll get into timelines and 15 what our expectations are for the review that we have 16 ahead of us.

17 So to introduce this, this is just kind of 18 a high level flow chart to highlight the main pieces 19 of the construction permit review. We have two 20 parallel reviews that we'll be going on.

21 And this is our safety review of your 22 preliminary safety analysis report and the 23 environmental review of your environmental report.

24 The results of each of these reviews will 25 feed into a number of things that will lead ultimately NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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35 1 to the commission's decision to either grant or deny 2 your request for a permit.

3 The review, the output of that will be the 4 safety evaluation report prepared by the staff. That 5 will be reviewed by the ACRS.

6 And as part of their independent review, 7 it will also be considered by the commission and the 8 mandatory hearing.

9 There's also a possibility that there 10 could be contentions filed as a result of this. And 11 we'll talk a little bit more about that in a few 12 slides, but that's another step that could be in this 13 process.

14 The environmental review will also be, the 15 environmental impact statement that's being prepared, 16 will also be considered by the commission and its 17 decision to grant or deny the construction permit.

18 So right now I'm going to turn the 19 presentation over the Nancy Martinez, the project 20 manager leading the review of your environmental 21 report. And she's going to talk through some of the 22 specifics of the environmental review process and the 23 status of their review.

24 MS. MARTINEZ: Thank you, Steve. As Steve 25 mentioned, I'm the environmental project manager for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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36 1 the application. And I'm going to discuss the 2 environmental review process.

3 The environmental review is going to be 4 performed in accordance with the National 5 Environmental Policy Act of 1969. Commonly known as 6 NEPA.

7 NEPA requires fellow agencies to follow a 8 systematic approach in evaluating the potential 9 environmental impacts of the proposed action and to 10 assess the alternatives to those actions. The NEPA 11 process involves public participation and disclosure.

12 NRC's environmental regulations 13 implementing NEPA are contained in 10 CFR Part 51.

14 Slide 17 please. This slide presents an 15 overview on the steps that lead to the environmental 16 review process.

17 When an application is submitted to the 18 NRC, the NRC conducts an acceptance review. And an 19 acceptance review determines if the application has 20 sufficient information for the staff to conduct its 21 technical review.

22 If the application is accepted, the NRC 23 staff conducts a NEPA document determination. And 24 that is to whether develop and prepare an 25 environmental assessment or an environmental impact NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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37 1 statement.

2 I will discuss in later slides, for the 3 Northwest application, the staff determined to prepare 4 an environmental impact statement. Once the NEPA 5 determination is made, the environmental review 6 process is conducted in accordance with 10 CFR Part 7 51.

8 Slide 18 please. This slide presents an 9 overview for NRC's environmental process.

10 Specifically for the environmental impact statement.

11 The environment review for an EIS begins 12 with the scoping process. Which includes a public 13 meeting.

14 Scoping is a process by which the NRC 15 staff identifies a specific impact and significant 16 issues to be considered in preparation of the 17 environmental impact statement.

18 Following the scoping process, the NRC 19 staff will perform its environmental analysis, which 20 will consist in part, of issuing request for 21 additional information to the applicant and preparing 22 the draft EIS.

23 The draft EIS is issued for public 24 comment. Once comments are received on the draft, the 25 NRC staff will consider those comments and issue its NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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38 1 final environmental impact statement.

2 Slide 19 please. The environmental review 3 for the environmental impact statement will take 18 to 4 22 months. This slide provides a detailed breakdown 5 of the process and timeframes.

6 As I previously mentioned, the 7 environmental review will begin with the scoping 8 process. Which for Northwest consisted of a 45 day 9 scoping period and a public meeting.

10 After the scoping period ends, the staff 11 develops a scoping summary report that addresses 12 public comments that were received during the scoping 13 period. This takes a minimum of 90 days and depends 14 on the number of comments that were received during 15 the scoping period.

16 The environmental analysis, in part, will 17 consist of developing and issuing a request for 18 additional information. Each round of RAIs will take 19 approximately 90 days.

20 And this will consist of developing and 21 issuing the RAIs, a 30 day response period and then 22 the staff reviewing the responses for clarity and 23 adequacy. The number of RAI rounds will depend on the 24 quality of RAI responses and the application.

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39 1 RAI responses, the scoping process, coordination with 2 other federal, state, tribal and local agencies, as 3 well as the staff's independent research, will be used 4 to draft the EIS.

5 When the draft EIS is published, it will 6 be made publically available for review and comment 7 for a 45 day period, in accordance with our 8 regulations. The comment period will include a public 9 meeting.

10 After the draft EIS comment period, the 11 staff will respond to comments provided on the draft 12 EIS and update the EIS as necessary. And this can 13 take approximately 120 to 150 days. And depends on 14 the number of comments and also the necessary EIS 15 updates. The final EIS is then issued.

16 Slide 20 please. The staff will perform 17 its environmental review in accordance with 10 CFR 18 Part 51. And will also use Interim Staff Guidance 19 augmenting NUREG-1537.

20 Slide 21 please. On February 5th, 2015, 21 Northwest resubmitted Part 1 of its construction 22 permit application. The public notice of receipt and 23 availability was issued on April 21st, 2015.

24 The NRC staff conducted an acceptance 25 review of the Northwest environment report, Chapter 19 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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40 1 of the application, in accordance with 10 CFR Part 51, 2 which identifies the information that shall be 3 contained in the applicant's environmental report.

4 An acceptance review is a completance 5 review that determines if the application has 6 sufficient information for the NRC staff to begin its 7 technical review.

8 Part 1 of the Northwest application was 9 accepted and the notice of acceptance was issued on 10 June 8th, 2015.

11 Slide 22. In accordance with 10 CFR 12 51.25, the staff determined whether to prepare an 13 environmental assessment or an environmental impact 14 statement.

15 Pursuant to 10 CFR 51.20(a)(2), the staff 16 determined that an EIS should be developed for the 17 proposed action. This determination was based on 18 operation of the proposed Northwest facility.

19 Connected action to the issuance of a 20 construction permit, consisting of target fabrication 21 and scrap recovery. A process similar to the process 22 used by field fabrication facilities, for which an EIS 23 is required under 10 CFR 51.20(b)(7).

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41 1 and decommissioning of the Northwest facility. We 2 will also consider the impacts of alternatives to the 3 proposed action, including alternative sites, 4 alternative technologies and the impacts of not 5 issuing a construction permit.

6 The environmental impact statement will 7 also consider the impacts from irradiation services 8 provided by the research and test reactors. Which is 9 a connected action to the proposed action.

10 Ultimately, the purpose of the 11 environmental review is to take a detailed hard look 12 at the environmental impacts of the proposed Northwest 13 facility. And after balancing the benefits versus the 14 cost or impacts of the proposed project, make a 15 recommendation to the commission on whether or not to 16 issue a construction permit.

17 Slide 24. The Northwest environmental 18 scoping period ended January 4th, 2016. The staff is 19 currently developing the scoping summary report and 20 responding to comments.

21 Two rounds of RAIs have been issued. The 22 first on November 2nd. Northwest responded to those 23 RAIs on December 3rd. The staff reviewed the 24 responses and had some follow ups. And those RAIs 25 were issued on January 19.

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42 1 NRC anticipates that the draft EIS will be 2 issued on October 2016 and that the final EIS will be 3 issued on May 2017. And this is based on the 4 timeframes in the slide that I have provided earlier.

5 And is keep within the 18 to 22 month schedule.

6 And that concludes my presentation on 7 environmental review.

8 MR. LYNCH: All right, next slide please.

9 For those on the phone, this is Steve Lynch again.

10 And I'm going to talk a little bit about the 11 construction permit safety review process.

12 Briefly touching on the content of the 13 PSAR in a little bit more detail, as well as going 14 through some of the assumptions that we made and 15 coming up with this 18 to 24 month timeline for our 16 review schedule.

17 So as I mentioned, I've mentioned most of 18 this before. The main components of the preliminary 19 safety analysis safety report are the preliminary 20 design of the facility. A preliminary analysis of 21 structure systems and components with an eye towards 22 how those will be used to prevent and mitigate 23 accidents.

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43 1 for the application to identify probable subjects of 2 technical specifications.

3 And again, while emergency plan also is 4 not required, there are some requirements in Appendix 5 E of Part 50, to address a preliminary emergency plan.

6 We'll also be looking at your quality 7 assurance program and any planned research and 8 development that you have.

9 Next slide please. So for the review that 10 we do, so the last slide talked about the regulatory 11 requirements that need to be met. We had developed 12 guidance in order to evaluate whether those 13 requirements have been met.

14 And for your application, the guidance 15 that we are primarily using is NUREG-1537, as 16 augmented by Interim Staff Guidance.

17 And the most applicable part of that, as 18 you used in the development of your application, was 19 the guidance for radio isotope production facilities.

20 And that was largely based on guidance in NUREG-1520 21 that Dave will talk about in a little bit.

22 Other guidance that we used. There are 23 ANSI standards that are referenced in these documents 24 we used for our reviews as well.

25 Next slide please. So getting more into NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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44 1 the process and timeline. After you submit your 2 application, first thing the NRC staff does is review 3 the application to see if we have enough information 4 to accept it for docketing.

5 What goes into this acceptance review is, 6 we look at the request you made for the type of 7 application you are seeking. We see if we have the 8 technical information, the application to support that 9 request to conduct our review.

10 And if we're aligned on the request you're 11 making and we think we can review it under that 12 licensing process, then we make sure that we have all 13 of the information required by the regulations for 14 that process.

15 We're not doing a detailed review at this 16 time, we're looking for completeness of the 17 application. And if we believe that the application 18 is complete and has addressed all of the regulatory 19 requirements necessary for that type of application, 20 we will accept the application and docket it.

21 And once docketed, that indicates the 22 beginning of our formal technical review of your 23 application.

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45 1 evaluation report. Which documents the NRC's findings 2 on the application and our recommendation to the 3 commission on whether we believe the construction 4 should be, permit should be granted or not.

5 In support of development of this safety 6 evaluation report, the staff may find it necessary to 7 request additional information to help us understand 8 the information that's in the application or to 9 provide any additional details we need to make our 10 conclusions.

11 After we complete our safety evaluation 12 report, we will present this report and you will 13 present your PSAR to the ACRS. There will be 14 subcommittee and full committee meetings on this.

15 And the ACRS will provide an independent 16 review of your application and the NRC staffs 17 evaluation and provide a recommendation to the 18 commission on whether they believe the construction 19 permit should be issued.

20 Following this, we do have the potential 21 for a contested hearing. And there will be a 22 mandatory hearing. Where, again, the adequacy of the 23 safety and environmental reviews will be considered.

24 And that will ultimately lead to the decision to grant 25 or deny the construction permit.

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46 1 Next slide please. So I put together a 2 sample 22 month safety review timeline that's based on 3 our previous reviews. And also just kind of a middle 4 ground between that 18 to 24 month time period.

5 And I wanted to highlight just some of 6 what went into that so it doesn't, it isn't a complete 7 mystery of what we're doing while we're reviewing your 8 application.

9 So after docketing your application, 10 within about two months we are, our goal is to begin 11 issuing requests for additional information, if 12 necessary.

13 Our goal is to complete issuing our first 14 round of request for additional information within 15 about a six month time period. So that will take us 16 to, as you see on the screen there, in eight months 17 after the docketing of the application, our goal is to 18 issue all of the requests for additional information 19 that we may have on your application.

20 Typically, when we issue a request for 21 additional information, we will ask for a 30 day 22 response timeframe. If this is not something you 23 believe you can meet, you can talk to your project 24 manager and workout a time period that will work for 25 both of you.

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47 1 So after about nine months, our goal would 2 be to have received responses from you on all of the 3 requests that we have issued. Following that, 4 reviewing the information and providing request for 5 additional information, it may be necessary to ask 6 additional RAIs.

7 So in this timeline we've incorporated the 8 need for a potential second round of requests for 9 additional information. That would require another 10 six months' time period.

11 After all of our requests for additional 12 information have been answered, and the staff is able 13 to complete a safety evaluation report, then we go the 14 ACRS. And right now, in this timeline, we have about 15 19 months after accepting the application for 16 docketing, we would hold our first ACRS subcommittee 17 meeting.

18 Based on our past experiences, with 19 licensing similar applications, we have seen that it 20 will be likely necessary to have multiple ACRS 21 subcommittee meetings.

22 In this timeline we have anticipated there 23 could be two ACRS subcommittee meetings. And these 24 can be held, essentially you would have an 25 opportunity, at most, once a month, while the ACRS is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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48 1 in session, to meet with them to discuss that.

2 Once the ACRS is satisfied, at the 3 subcommittee level, that you have addressed all of 4 their technical concerns with the application, a full 5 committee meeting can be scheduled. And after the 6 full committee meeting, the ACRS would prepare its 7 recommendation to the commission on your application.

8 Following the completion of the ACRS full 9 committee, the staff has been able to finalize its 10 safety evaluation report based on feedback provided by 11 the ACRS. And after that is when we would schedule 12 the hearing.

13 Next slide please.

14 MR. ADAMS: Can I, this is Al Adams, can 15 I -- I just want to emphasize one point on this slide.

16 Although this slide shows 22 months, that you can see 17 the licensing activities are completed on this slide 18 in the first 18 months.

19 So there is time that is devoted to 20 activities, which are beyond the development of the 21 safety analysis. The visits to the ACRS and the 22 mandatary hearing.

23 So although it may seem like a 22 month 24 schedule, the actual licensing work is condensed into 25 the first 18 months of that. Thanks.

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49 1 MR. FOWLER: And what I -- pardon the 2 interject here, but I see, you know, the objective 3 that I have in this meeting are to explore, how do we 4 accelerate schedules.

5 MR. LYNCH: Yes.

6 MR. FOWLER: And I appreciate this 7 outline. There is implicit assumptions about cycles 8 in here.

9 And that's an obvious opportunity to 10 reduce the overall time, if we reduce the number of 11 cycles.

12 MR. LYNCH: Yes.

13 MR. FOWLER: What is less clear to me is, 14 what drives subsequent cycles? Is there a threshold?

15 What's the bar that we, as a company, need 16 to meet to avoid a subsequent cycle and therefore 17 accelerate the schedule? That's what's not so clear 18 to me.

19 MR. LYNCH: So I think that there's a 20 number of things that we can do. And when we ask, 21 what we can do is, when we ask, request for additional 22 information, it's important that you understand the 23 questions that we're asking.

24 You can go to the next slide. Let me 25 answer your question and then we'll go through the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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50 1 slides as well. You can click to the next slide. But 2 it's all related. That's the next topic I was getting 3 to.

4 But when we issued the request for 5 additional information, it's important that after 6 they're sent to you, you have them, read through them, 7 have a phone call with us. If we need to meet, we can 8 do that as well.

9 But we want to make sure that for every 10 question we ask, you clearly understand what we're 11 asking. And if you don't understand, you ask us to 12 clarify.

13 Because it cannot be the best use of 14 either of our times if you don't understand the 15 question we're asking. You answer what you think 16 we're asking, but that's not what we're looking for, 17 then we have to ask the question again.

18 So making sure that we have a clear, 19 mutual understanding of what the information gap is 20 that needs to be filled, that can help.

21 And then as you're preparing your 22 responses, check in with us again and make sure that 23 you still understand and you're going down the right 24 path. And providing complete answers the first time 25 they're asked can also help.

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51 1 So I think one of the keys two reducing 2 the iterations that we have to go through in that RAI 3 process, is making sure that you understand the 4 question that's being asked and providing complete 5 responses to that.

6 MR. FOWLER: So we're learning how to work 7 with each other?

8 MR. LYNCH: Yes.

9 MR. FOWLER: And we've had some 10 experience. And, Nancy, maybe I can put you on the 11 spot here because we've now had two cycles of requests 12 for additional information with the environmental 13 portion of the technical review.

14 How would you characterize the ability for 15 the two organizations to communicate?

16 Is the second cycle driven by a 17 communications challenge or is it driven by, you peel 18 the layers of the onion back and you find something 19 that you didn't see the first time that initiated a 20 second round of questions?

21 So in order to be productive, help us to 22 understand, from the limited experience we have 23 already, how we could do it even better on the next 24 cycle.

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52 1 review RAIs, the second round of those RAIs were 2 driven by follow ups to the first round where the 3 question was not addressed adequately. So we had some 4 follow ups on that.

5 But we also had some follow ups on the 6 responses because information was provided, and then 7 we needed additional information just based on the 8 response. It was really a combination of some of the 9 questions were not answered completely, and then there 10 was responses provided, and then we had follow up to 11 that.

12 We also did, you know, when we issued the 13 RAIs, as Steve mentioned, we did say, let us know if 14 these are clear and if you would like to have a call 15 to discuss them. We did that for both rounds.

16 So we're hoping that that will open that 17 communication channel, as you just said.

18 MS. GAVRILAS: I want to take it a step 19 higher, because this is general. So you mentioned the 20 two cases. Indeed, those are the two instances for 21 which we ask additional RAIs.

22 There's an expectation that the technical 23 reviewers have started to write their safety 24 evaluations and are well along their safety 25 evaluations.

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53 1 So when they ask, when they request 2 additional information, it's designed specifically to 3 augment the piece that they're writing right now. So 4 that means it truly -- they know exactly what they 5 want. Or they have a very clear picture of what they 6 want.

7 I'm not saying that the peel the orange, 8 you know, or onion, whatever you're peeling, doesn't 9 happen, but that's rare. Because of how we do, how 10 the expectation is that when you ask an RAI, you 11 basically know what kind of information you're seeking 12 to document your safety conclusion.

13 So along the lines of dialogue, there's 14 two times that there's opportunity for dialogue when 15 it comes to a request for additional information.

16 One is, when we are drafting the question 17 itself. Right? Because then we want to make sure 18 that we engage with you and make sure that the words 19 that we put on paper, do convey our needs.

20 And then there's a second opportunity to 21 engage in dialogue. Which is, when you've drafted 22 your answer, we have an opportunity to check that 23 indeed your answer answers the mail.

24 That is, in our experience, the most 25 efficient and effective way to deal with responses for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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54 1 additional information.

2 MR. LYNCH: Nicholas?

3 MR. TIKTINSKY: And I'd like to add a 4 little more on that too. A lot of it's nature of the 5 rounds of questions. And this is Dave Tiktinsky.

6 A lot of it is nature of the rounds of 7 questions. So if the questions are, you provided 90 8 percent of the information we want and we need some 9 clarifications of something, then usually it only 10 requires one round.

11 If the questions are more like, you need 12 to develop or give us your methodology that you, how 13 you develop something or you're programing, we need to 14 understand what that is. Once we get that answer, 15 about what your program is or what your methodology 16 is, that may lead us to other questions.

17 So really it's the nature of how the 18 information was in the application, how specific it 19 was. And really the level of what that question is.

20 The specific questions, usually can handle 21 them in one round. The more programmatic, methodology 22 kind of questions frequently require follow ups.

23 MR. ADAMS: And, this is Al Adams, I just 24 want to build on something Mirela said. That that 25 discussion that we have, once you start to develop NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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55 1 your answers, that's not a sort of a verbal review of 2 your answer.

3 I mean, you know, the reviewers have to 4 sit down and carefully consider the answers. What 5 that is looking for, if we're expecting an answer to 6 go in this direction, and when you talk to us, we find 7 out that you're going in a completely different 8 direction.

9 So it's basically to find significant 10 issues before you submit the answers to us. So if you 11 submit the answers to us without having that 12 discussion with us then, you know, then there's just 13 possibility for a misunderstanding or 14 miscommunications in the RAI process. And that can 15 contribute to additional questions.

16 MS. GAVRILAS: And we cannot, this is 17 Mirela again, we cannot emphasize enough how important 18 that dialogue is. Those are the, probably the biggest 19 contributors to our expediting the review.

20 MR. LYNCH: Okay. Actually, so I think 21 we've talked mostly through Slide 30. Let's go to 22 Slide 31, which will continue this conversation we 23 have on impacts to schedule.

24 And this, in addition to RAIs, there is 25 other things that we can do to help ensure that our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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56 1 review is moving along efficiently. And can impact 2 schedule.

3 One is the quality of the application 4 where all the regulatory requirements met. And this 5 is, I'm speaking hypothetically and not in your 6 application.

7 But if we do a review of the application 8 and the regulatory requirement is not met, it could 9 result in the application being rejected and needing 10 to be resubmitted. Or it could result in significant 11 new information that does need to be presented and for 12 review.

13 Technical and completeness. Again, the 14 more information you give us without having to ask for 15 it, the more efficiently we can review the 16 application.

17 And then also just attention to detail.

18 And this has to do with the organization of the 19 application, formatting, looking at proprietary 20 markings. Just those little details that maybe aren't 21 necessarily technical, but can help us in our review.

22 If we don't have to worry about the little things.

23 Then building on our conversation on 24 request for additional information, in addition to the 25 number of rounds we ask, the quicker that you provide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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57 1 responses to us, the quicker we can continue on with 2 our review.

3 So timeliness, responsiveness, 4 completeness of our requests and how you provide 5 answers to them, that can all help facilitate our 6 review.

7 And I think a good point that Dave 8 mentioned was, what can take more time is if in these 9 requests for additional information, significant new 10 information is provided that we have not reviewed 11 before. That can take additional time. And could 12 result in additional requests.

13 MR. ADAMS: Can I -- Al Adams. Can I jump 14 in here?

15 And completeness is probably the most 16 important of those things. If you, you know, we asked 17 for a 30 day response and you come in in 20 days and 18 look, you know, you've come in ten days sooner. But 19 those answers aren't complete and result in another 20 round of RAIs, that round is going to consume a lot 21 more than the ten days that you saved by coming in 22 early.

23 So completeness is the most important, I 24 think, aspect of this. And I think what you're seeing 25 is, you know, the thing that draws out schedules is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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58 1 having to go additional rounds of RAIs.

2 That's the most, you know, our experience 3 has shown us that's the most significant contributor 4 to schedules being drawn out.

5 MR. TIKTINSKY: Another thing I might want 6 to add too is, we're not going to wait till the end to 7 give you all the RAIs at one time. You saw that, the 8 schedule that Steve had shown there.

9 The idea is, when major portions of the 10 review are done, we will ask RAIs that are 11 appropriate. We don't want to be asking you the same 12 technical area a bunch of different times.

13 So when we're done with an area and we 14 feel like we're done with that part of the review and 15 comfortable with that, we'll ask those rounds of 16 questions. But we want to spread it out over that 17 time period, the six month time period that Steve had 18 outlined.

19 It's more efficient that way and it allows 20 your staff to work on it. Also, we don't want to hold 21 somebody up, you know, waiting for another disciplines 22 review to be done.

23 MR. ADAMS: So you may get a second letter 24 from us, but it's actually the first round of RAIs in 25 that area. And there's nothing to be gained by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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59 1 sitting on the RAIs and giving you a hundred questions 2 at once and overwhelming your ability to answer.

3 So when we have an area ready to go, we 4 will send it to you to allow you to spread out your, 5 you know, your limited resources also. And ours too.

6 MS. HELTON: This is Shana Helton. I'd 7 just like to reemphasize that when, especially when 8 you're crossing different portions of the regulations, 9 that the clearer you are in your initial submittal 10 about, this is how we're meeting 70.32, this is how 11 we're meeting 50.20.

12 I mean just the clearer you are in your 13 application, will help us avoid those types of request 14 for additional information where we say, hey, tell us 15 how you're meeting the requirements in here.

16 And then if we're at that sort of basic 17 level of, how are you meeting the regulations when you 18 give us that answer, that's almost guaranteed a second 19 round because now we're going to ask you questions 20 about that.

21 I mean every applicant wants to avoid 22 going multiple rounds of request for additional 23 information. But it's just been our experience that 24 when we have to do those basic sort of questions 25 about, how are you meeting our regulations, that tends NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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60 1 to, once we see the detailed technical information, we 2 tend to then have questions about that.

3 So I can't emphasize enough that initial 4 clarity in your submittal.

5 MS. GAVRILAS: So if I -- I'm sorry.

6 MR. MORRISSEY: No, that's okay.

7 MS. GAVRILAS: More comments on RAIs.

8 Because I want to --

9 MR. MORRISSEY: No, I had just a 10 discussion about the technical reviews. My name, 11 Kevin Morrissey.

12 As having been a technical reviewer for a 13 long time, and actually I was a licensee, is my advice 14 would be, don't be shy about asking the staff what 15 they want.

16 You know, we're talking about all the 17 things we expect from you, you should expect to think 18 the same things and clarity from the staff. You know, 19 lots of time we go, I shouldn't ask this, I shouldn't 20 ask that. Is you really have to dig down sometimes 21 and let your staff talk to our staff and really get 22 down to exactly where you're going.

23 Then you're less likely to end up in the 24 wrong place and wasting your time. So don't be shy.

25 That would be my advice.

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61 1 MS. HELTON: Absolutely. Getting the 2 technical experts to communicate directly so there's 3 an understanding, is a good practice. To have a 4 public meeting on those RAIs.

5 MS. GAVRILAS: So again, it's important to 6 sum up. It's important to distinguish between various 7 increments at the same round, the RAIs and follow up 8 RAIs.

9 The increments are designed to help us 10 all. To move the process along.

11 The follow up required are basically 12 because we needed additional information. And while 13 we can't, those are the ones that we target for, for 14 minimizing. We can't eliminate them completely, but 15 we target for minimal follow up RAIs.

16 I want to go back on Slide 30, Steve, if 17 you can, for just one moment. Because there's --

18 we've talked a lot about RAIs and how you can do, what 19 you can do to basically help us out, speed the process 20 along.

21 But what's important in our timeline is 22 also to recognize that there's a safety reason for how 23 the timeline is developed. There's nothing that's 24 carved in stone, because it's arbitrary.

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62 1 writing of the SER. It doesn't help to distribute a 2 chapter in a technical area amongst reviewer. That 3 won't speed up the process. The review has to be 4 comprehensive. The reviewer needs to see everything.

5 If there are chapters that cross over 6 technical expertise, that needs to be seen by 7 everybody. So the timelines that you see that it 8 takes the staff to draft the SER and to come up with 9 RAIs, is also informed by basically what we need to do 10 to come up with a safety finding.

11 And with that, I'll turn it back to where 12 it was.

13 MR. LYNCH: Sure. Back to Slide 31.

14 Again, this is Steve Lynch. Other impacts that, to 15 schedule, could be if there are policy questions that 16 need to be resolved. I can give an example from a 17 past, a past review.

18 In the case with SHINE, we had to go to 19 the commission to resolve how, you know, whether SHINE 20 should be under Part 50 versus Part 70, and we ended 21 up needing to do a rulemaking in order to classify 22 them under Part 50. That can be a potential impact to 23 schedule if that's something that's necessary in our 24 review.

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63 1 schedule, is the number of times we have to go to the 2 ACRS. Limiting the number of subcommittee meetings 3 that we have to have, by addressing the technical 4 concerns with the ACRS, can significantly improve or 5 delay the schedule.

6 MR. ADAMS: Al Adams. I just want to, the 7 ACRS tells us when they've received enough information 8 before they can write the letter they need to write to 9 the commission.

10 So it's something that quality has control 11 over, but we don't run the ACRS and the committee.

12 And they have to do the review and reach the 13 conclusions they need to reach given what they're 14 responsibilities are.

15 MR. LYNCH: Yes. And what we can do to 16 help them is, when they do identify areas that they 17 need additional information, that both the applicant 18 and the NRC staff provide that as quickly as possible.

19 All right, next slide please. So on the 20 previous slide I was mostly addressing the things that 21 both the applicant and the staff can do to impact 22 schedule.

23 This slide is focused on the things that 24 are outside of the staff and the applicants control, 25 to a certain extent. And this gets into the hearing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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64 1 process.

2 And this comes after the ACRS meeting has 3 been held, the staff has completed its environmental 4 impact statement and the staff has completed its 5 safety evaluation report.

6 There will be a mandatory hearing on this 7 application since it is a commercial facility. And as 8 I just mentioned, but there's a lot of things that 9 have to happen before this mandatory hearing can be 10 held.

11 In addition, there is a potential, and we 12 put this out in our notice of opportunity for hearing, 13 members of the public could file a contention on a 14 portion of the application or the activities that are 15 being conducted. Or proposed.

16 And if that happens, those separate 17 hearings would need to be held and those issues 18 resolved before the mandatary hearing could be held.

19 After any hearings that need to be held 20 are held, including the mandatary hearing, then we get 21 the Commission's decision to deny or issue the 22 construction permit. Based on what we've seen for the 23 combined operating license applications, that have 24 followed a similar process to this, we have seen the 25 commission decision come anywhere between two and five NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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65 1 months following the mandatory hearing.

2 So after the hearing happens, there is 3 additional time. And that's not time that the staff 4 can control, that's on the commission's schedule when 5 they make that decision.

6 Next slide please.

7 MR. BALAZIK: Hey, this Mike Balazik. I'd 8 like to provide a quick status update on the NRC's 9 review of Northwest construction printout application.

10 This slide shows the proposed schedule for 11 the review. Steve and others mentioned some items 12 that can drive the schedule, either delay or expedite.

13 As you can see, that NRC is actually 14 reviewing the application. And I just want to assure 15 you that we've allocated the necessary resources and 16 have the technical expertise to review all aspects of 17 the application.

18 As you can see on this schedule, the staff 19 has targeted September of 2017 for completing the 20 safety evaluation report. And then there's a couple 21 of milestones that we can't really put a date next to 22 yet.

23 There's a couple of related activities, 24 not on this schedule, I'd like to mention. One is the 25 license amendment application by Oregon State NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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66 1 University to irradiate three prototype targets. This 2 amendment was issued in January of 2016.

3 And other item I'd like to mention is, for 4 the research reactors that you've proposed to do the 5 irradiations for Northwest, each research reactor 6 would have to submit a license amendment to irradiate 7 the targets commercially.

8 And we've received notice from the 9 University of Missouri that we can expect the license 10 amendment in calendar year 2016. And Oregon State 11 University has also notified the NRC that they plan to 12 submit their license amendment in first quarter 13 calendar year 2017.

14 MR. LYNCH: Okay. While we're on this 15 slide, do you have any questions about our review 16 schedule?

17 I think, and this is mostly based on 18 previous reviews and the sample timeline that we 19 developed. Do you have any questions on where we're 20 going?

21 MR. FOWLER: Well, I have an observation.

22 And I appreciate this information. And I was somewhat 23 familiar with reading it.

24 And again, I'm looking to explore how we 25 can work together, while maintaining arms' length.

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67 1 Obviously you have an ombudsman role and a review role 2 that is independent and so forth.

3 But I view this as a very critical public 4 health need. And I know everyone recognizes that, but 5 our sponsors and investors are major healthcare 6 institutions servicing tens of millions of Americans.

7 They see this as a real issue that we do work 8 together.

9 They are not for profit organizations.

10 They have a service mission to the American public.

11 And they extend that service mission through us. To 12 provide this.

13 And they're expectation is that we work 14 collaboratively and creatively to not compromise 15 health or safety, but figure out ways where we can 16 reduce the number of RAIs.

17 How can the NRC better set our 18 expectations of what will minimize those rounds of 19 RAIs?

20 How can we work together to ensure that 21 the ACRS review is done in a single pass, rather than 22 two or three passes?

23 What do we need to do together?

24 And if we drop the ball, it's on us.

25 Absolutely it's on us, if we drop the ball.

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68 1 But if we know what the threshold is that 2 we're trying to reach, we will work our darndest to 3 get there. And that's what we're looking for. Is, 4 how do reduce the number of RAIs?

5 How do we, as much as we can, ensure that 6 there aren't multiple rounds through the ACRS?

7 Because if we reduce those number of 8 rounds and if we reduce the assumed number of RAIs, we 9 get a critical isotope to public much more quickly 10 than is even on this schedule. Or we, by insurers, 11 that this schedule is met and doesn't slip.

12 And that's the exploration that I'm very 13 keen on hosting. Because I think we have an 14 understanding of the process. Now how do we work 15 within that process, to have the most expedited 16 schedule possible?

17 MR. LYNCH: Okay. So I think, just at a 18 high level -- so where we're at right now, we're in 19 this February 2016 timeframe. We're anticipating 20 getting out our first request for additional 21 information on the safety review side. And I believe 22 we're on target for that.

23 So this is all heading towards completing 24 our draft safety evaluation report. So I guessing 25 you're looking at drive, making that June 2017 time NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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69 1 come up sooner.

2 I think the best chance we have of working 3 towards that goal together, would be once those 4 requests for additional information are issued, just 5 like we discussed earlier, let's get a call setup as 6 quickly as possible so that we can discuss and make 7 sure you understand what we're asking. And --

8 MR. FOWLER: So to that point, Steve.

9 MR. LYNCH: Yes.

10 MR. FOWLER: You have insight by the 11 technical reviewers when an RAI is going to be issued.

12 So rather than wait until it's issued, for us to 13 request a public meeting to follow up and then have 14 the mandatary noticing period and so forth, why don't 15 we automatically schedule a public meeting within 16 certain number of days of the RAI insight issuance, so 17 they don't have to wait longer?

18 MR. LYNCH: There are different ways that 19 we can do this. Yes.

20 And there have -- and the NRC can, you 21 could set up a standing public meeting once a month or 22 once every two months. You know, something like that.

23 That could definitely happen so it's noticed and it's 24 already setup. That can be done.

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70 1 discussion you would like to have on the RAIs. The 2 public meetings are more necessary if we need to have 3 detailed technical discussions about the RAIs.

4 If you would like to have a call, just 5 strictly on, do you understand this, yes or no, could 6 you explain to me at a high level if I'm not 7 understanding what it is, that does not necessarily 8 need to be a public meeting. That could be a phone 9 call between you and your project manager.

10 Or you and with appropriate technical 11 staff. Those could be very quick calls. If it's just 12 for understanding.

13 So it kind of depends on what we need. So 14 that can buy some time too. If it doesn't need to be 15 a public meeting, that can be done much more quickly.

16 MS. HAASS: Well, and that's why there was 17 the request, when we were at the EDO, was to go get 18 that standing meeting done every week, very short and 19 sweet, to say, okay, do we understand this. And then 20 we move on.

21 And so I'm glad that that got instituted 22 or executed that we're now doing that. And that has 23 helped.

24 MS. HELTON: I think when you talk about 25 the frequency, the right frequency for the standing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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71 1 public meetings, and they haven't been established 2 yet, but we certainly can do that. And we've got 3 other examples working applicants where we've met on 4 a biweekly basis.

5 So in terms, I wanted to chat and, I'm 6 sorry, this Shana Helton, about this question on 7 threshold. And what's the regulatory threshold that 8 you have to meet, as the applicant, to operate this 9 facility.

10 So the regulations, we went over the 11 NUREGs as they've been supplemented by the Interim 12 Staff Guidance. That is what we have set as the 13 threshold, if you will.

14 And each applicant is going to meet those 15 regulations in unique ways. With that said, you know, 16 we operated in a public manner. Everything is on the 17 docket.

18 We've alluded to similar reviews in terms 19 of looking at reducing the number of RAIs. I think it 20 would be helpful for you to do some research in ADAMS 21 for what similar designs, the types of requests for 22 additional information that we have had, and the types 23 of responses that have satisfied those additional 24 requests for information. And that should really help 25 to identify the threshold.

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72 1 I mean that said, each application is 2 different, we review it on its merits. We're going to 3 have to take into consideration the unique factors.

4 But that can at least give you a sense of the way we 5 think when we're going through these regulatory 6 reviews.

7 MR. LYNCH: Absolutely. I think that's a 8 very good point. And even more detailed in that, if 9 you really want to see, if you open up the safety 10 evaluation reports we write, especially those -- you 11 can look, for a good example, we just finished our 12 safety evaluation report for the SHINE review. And 13 using the same guidance that you used.

14 The guidance sets the threshold of the, at 15 the end of that, the NRC is explicit and the 16 conclusions that we are trying to make in each section 17 and each chapter that's provided. And there are 18 bullet points there.

19 And once our reviewers are doing the 20 reviews, they're looking at the bullet point, you 21 know, for the acceptance criteria. Was this 22 information provided. And then there's another bullet 23 point, can we draw this following conclusion from that 24 information.

25 So when we're looking at your application, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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73 1 we're trying to answer those questions. If we can't 2 answer a question affirmatively, that's one of the 3 times we'll go to you for a request for additional 4 information.

5 Also, as you'll realize for a construction 6 permit, you may not have all of the information that 7 you would submit at the operating license stage. What 8 can also help the reviews is an explanation of the 9 information that you don't have right now, because 10 your design isn't compete, explaining why it's not 11 ready right now, but also acknowledging that you 12 recognize it is something necessary for the final 13 design.

14 The more, again, it comes back to the 15 completeness. The more information that you can 16 provide us, addressing the information that we're 17 looking for in the guidance, the quicker we can get 18 through the review.

19 And also we are kind of, since we're using 20 our guidance, NUREG-1537 and the ISG, that's kind of 21 the format that we're looking for. You can submit 22 your application in whatever form that suits you.

23 However, if you can expedite the review, 24 it does make it easier if it's generally aligned with 25 the guidance that we're using to go through with. So NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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74 1 that's some other insight.

2 MR. TIKTINSKY: If I could add some more 3 on the RAI meetings? You're right. We don't just 4 wait until they're all done and then make a phone call 5 to you. We know when they're coming, we know when the 6 reviews are done because we, as project managers, we 7 work internally with our reviewers to try and make 8 sure we're asking questions that are clear, that have 9 appropriate regulatory basis.

10 So we're working internally. So we know 11 pretty, some time in advance, before we're getting 12 ready to formally issue the rounds of RAIs. And we've 13 had a lot of experience doing that. And having 14 setting up meetings.

15 And just for your information, you know, 16 parts of the information, like within the ISA, there's 17 other categories, besides proprietary information.

18 There's security related information.

19 So the public meetings that we have, we 20 try and talk as much as we can in publically available 21 information. But there may be some portions of the 22 meetings that are closed. Not only for proprietary, 23 but for security related information and other 24 discussions.

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75 1 in RAI, we try as best as we can to make the RAIs 2 themselves publically available. So that information 3 is out there.

4 Your answers may or may not be publically 5 available, but like I said, we've had a lot of 6 experience in other reviews of making sure we have 7 those conversations.

8 I'd also like to emphasize the point too 9 is, depending upon the nature of the answers, we do 10 the same thing. Have the same kind of meetings when 11 you submit answers.

12 So before you formally submit something to 13 us, it may be a call or you may have a meeting too.

14 If you have substantial discussions about something to 15 make sure that you're really are hitting the mark.

16 Again, we don't do reviews on the fly, but 17 you can get a pretty good sense that, yes, if you're 18 on the right track or not. And that would minimize 19 any problems.

20 But yes, we do plan things out. We try 21 and coordinate that carefully with the reviewers. And 22 we know where the status of things are.

23 And again, that's why I mentioned before, 24 we're not going to just consolidate a bunch of 25 different disciplines and do it at one time, we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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76 1 going to try to phase this through, review it and try 2 to make it as efficient as we can.

3 MR. ADAMS: And this is Al. I'll just add 4 two things. One is, NUREG-1537 is a guidance 5 document, but it is an important document in that it's 6 a format content guide and the staff standard review 7 plan.

8 What we expect for RAIs is that the RAI 9 will start by saying, either here's a regulatory 10 requirement or here's something that the standard 11 review plan is looking for, here's where your 12 application, the information in your application seems 13 to say something different or doesn't seem to have 14 this information. And then the question will come.

15 So, you know, NUREG-1537 is your friend 16 for understanding what we're looking for.

17 The other thing, you talked about the ACRS 18 for similar application to yours. There are 19 transcripts of the ACRS meetings. You can go read 20 those transcripts and see what areas interest the 21 ACRS, what areas they focused on, where they asked 22 both us and the applicant questions and issues that 23 became, you know, issues that were sort of follow-on 24 issues.

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77 1 second in the queue that there is information that's 2 available to you. And that's an important source of 3 understanding how the ACRS works, what they think, 4 what they look at, what they consider important.

5 MS. HELTON: Also publically, this is 6 Shana Helton again, also publically available on the 7 advisory committee is their charter. You know, I 8 encourage you to look at that. They're mandated by 9 statute. They're an advisory buddy to the commission.

10 The staff does not have much influence 11 over how they operate with their schedule. The 12 members need whatever information they need before 13 they'll go to a committee and write a letter.

14 So while we can attempt to work with the 15 ACRS and, you know, it's very difficult to try to 16 manage that schedule. They've got competing demands 17 and they only get together once a month. There are 18 certain months of the year that they typically do not 19 meet. So it tends to be fair.

20 You know, you see an August meeting up 21 there, I don't think they usually meet in August.

22 Sometimes they make --

23 MR. LYNCH: Subcommittee does, full 24 committee does not.

25 MS. HELTON: Full committee does not. So NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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78 1 I'm just saying, there is some limitations in working 2 with the ACRS. They have a statutory role to fulfill 3 and they take it very seriously.

4 So looking at those old transcripts can 5 help try to predict what, as they're membership 6 changes, you know, it's just, it's a variable that's 7 well out of the staff's hands. That's all I can say.

8 MS. GAVRILAS: This is Mirela Gavrilas.

9 And we have, the staff has experienced working with 10 the ACRS. The staff knows the ACRS' schedule.

11 The ACRS itself, from our previous 12 experience, the ACRS too recognizes the importance of 13 this activity. Of establishing a reliable, domestic 14 supply of molybdenum-99.

15 So while there are challenges, they will 16 work with us. We know how to work with them. And 17 past experience says we've been successful to make 18 that as effective of interaction as possible.

19 MS. HELTON: Absolutely.

20 MR. BALAZIK: This is Mike Balazik. I 21 guess I just have one question. We've been, for the 22 environmental review, we've been through two rounds of 23 RAIs.

24 We have been sharing those in draft form.

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79 1 can do on these?

2 I mean, I guess I'm just kind of asking, 3 what can we do differently? We've been through two 4 rounds to help Northwest with the understanding of the 5 RAIs. I guess it's just a question that --

6 MS. HAASS: Yes, I don't think there's a 7 disagreement of we don't understand the RAIs. There 8 were actually, you know, we had a public meeting, you 9 know, when we did the site visit, there was some 10 agreement that the RAIs were complete. You did come 11 back and then say you wanted some additional 12 information.

13 Then there were quite a few additional 14 ones in the second round as well. And it was based 15 upon some additional information you asked for.

16 And so I do think it's complete. And it's 17 sitting here for you.

18 MR. BALAZIK: But it, this is Mike Balazik 19 --

20 MS. HAASS: Now, there really isn't 21 anything else we can do accept keep communicating.

22 But remember, it wasn't until the EDO meeting, until 23 we requested that we have these weekly meetings here, 24 I'm sure that there was an understanding.

25 MR. BALAZIK: This is Mike Balazik again.

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80 1 There's a difference between the weekly status call, 2 which is just overall --

3 MS. HAASS: I know the staff, knowing what 4 we had and where there is a question and how we would 5 go about resolving that. And it could be a public 6 meeting or it could be just, you know, there was a 7 misunderstanding and it was just a quick, you know, we 8 understood it.

9 MR. FOWLER: So I see three areas that 10 offer opportunities to explore expediting. The first 11 I'll call administrative in nature. And those are the 12 mandatory noticing periods, the number of meetings and 13 so forth.

14 The better we can be in advance of 15 understanding when those need to happen, we can 16 eliminate more time that's simply waiting for one of 17 these periods. Or waiting to have a meeting.

18 That's probably the most frustrating to me 19 is having to wait for things. I never want either 20 team to be in a position of waiting for things.

21 Because that, by definition, is lost time in the 22 schedule. So I call that administrative.

23 Then there's this area of technical. And 24 what I'm -- I've heard the term, completeness used 25 sufficiently that it will be lodged in my memory.

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81 1 And so -- and that comes through dialogue.

2 In order to meet this threshold of completeness, the 3 technical teams need to be in communication so there's 4 no misunderstanding of what completeness is required.

5 And I want to test to see we have the 6 appropriate communications mechanisms in place, to be 7 sure we're meeting the completeness guidance.

8 Then there's the regulatory or precedent 9 guidance. Which comes to what I've termed threshold.

10 What threshold do we need to meet.

11 And that's really on us. We've got to do, 12 and have been doing and will continue to do, research 13 into threshold regulatory.

14 So those are the three areas. Obviously 15 the last one is something that we have to work on 16 independently.

17 The other two I believe are areas to 18 explore whether we've done everything together that we 19 possibly can do to meet and better the schedule.

20 And I'm sorry, Mirela, you were going to 21 make a comment.

22 MS. GAVRILAS: Wow, that was, I'm taking 23 notes furiously because I want to answer to, to answer 24 a couple of things.

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82 1 meetings are concerned, that's our practice. So I'm 2 not sure when we implemented it, but I know that we 3 had the same --

4 MR. LYNCH: We talked about it in 5 November. Or no, actually August, at the National 6 Academy of Science --

7 MS. HAASS: It just didn't get implemented 8 until about a month ago.

9 MS. GAVRILAS: Okay. But that is part of 10 our practice. To have those status meetings. But 11 their status meetings do not touch on anything that 12 Nick just mentioned.

13 Okay. So as far as communication, that's 14 what I was writing. The regulatory guidance is the 15 first place to look to see what the yardstick is for 16 completeness.

17 Our discussions, discussions with the 18 staff are intended to augment that. Not replace that.

19 So they come in addition.

20 And sometimes there's no additional needs 21 for communication. Sometimes there are needs for 22 communication.

23 So we need to work together. As soon as 24 you identify a need for further discussion, you need 25 to let us know. And we'll do our part in anticipating NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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83 1 when it's likely that you will have additional 2 requests.

3 Because, for example, if we know that 4 we're asking a broad reaching RAI, like Dave just 5 mentioned. If we're asking you something, what was 6 your methodology, then we can see how that would 7 require an interaction in the public to discuss 8 further.

9 So it's both sides. We both need to be 10 aware. And I think we can both, at least we can 11 committee to our part, to have that awareness and try 12 to be proactive.

13 MR. BALAZIK: Yes. And this Mike Balazik.

14 And the whole idea of the status call, the weekly 15 status call, that was to be implemented as when we 16 accepted the application.

17 I didn't see it, weekly calls, before 18 that, until we got to that point of acceptance of the 19 application. So that was --

20 MS. HAASS: And that was a little 21 different understanding. But no, I'm just glad it's 22 done.

23 MR. BALAZIK: Okay.

24 MR. LYNCH: So, just to finish up with 25 this slide, did we help with understanding ways that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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84 1 we might be able to help accelerate the schedule in 2 terms of strategy? Any other questions do you have on 3 that right now?

4 MR. FOWLER: I think I have a good 5 understanding of the areas that I tried to summarize.

6 MR. LYNCH: Okay.

7 MR. FOWLER: And what I would like to see 8 and what I would ask of our team is, okay, now 9 translate those areas into a plan. What are the 10 processes and procedures that we've put in place, what 11 are the accountabilities, what are the milestones, 12 what in fact are the definitions of success or lack 13 thereof so we know we're on plan or off plan.

14 It's all about project management, once we 15 understand what the plan it.

16 MR. LYNCH: Okay.

17 MR. BALAZIK: All right, this is Mike 18 Balazik, I'll continue on. We want to go through 19 docketing. Steve mentioned earlier what docketing 20 was. And I just wanted to go through the timeframe 21 for docketing of the Northwest application.

22 First I'll start with the Part 1.

23 Northwest submitted Part 1 of its application three 24 times. Once in October 15th, another time, 29th, and 25 November 7th of 2014. This was before providing the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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85 1 NRC with a version that was acceptable for processing 2 and conducting an acceptance review on February 5th.

3 The NRC issued a letter to Northwest on 4 January 23rd notifying Northwest its application was 5 incomplete and unacceptable for docketing. Northwest 6 was allowed 30 days to supplement that application.

7 And Northwest chose to withdraw the application and 8 resubmit. And that was the February 5th, 2015 date.

9 The reason for some of the delays was 10 inappropriate markings of proprietary information.

11 Also, ADAMS had rejected the document due to numbering 12 of pages.

13 When they see a document has so many pages 14 and it doesn't match up, they'll reject the document 15 and try and get it resolved.

16 So Part 1 of Northwest's applications 17 accepted for docketing in June of 2015. And that was 18 approximately two months after successfully processing 19 it into ADAMS.

20 And just real quick on Part 2. They 21 submitted the application, Northwest submitted the 22 application, on July 20th, 2015. However, due to 23 formatting and improper proprietary markings, the 24 application was not fully put into ADAMS until 25 September 18th.

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86 1 The staff completed its acceptance review 2 in the mid to late November 2015. And before 3 notifying Northwest on its acceptance decision, the 4 staff held a public meeting in late November. And 5 provided Northwest an opportunity to clarify its 6 requested licensing action.

7 Following the public meeting, the letter 8 of acceptance was issued in December of 2015.

9 One thing I would like to add is that 10 Northwest submitted large portions of its applications 11 in hard copy form, which lead to delays in processing.

12 In ADAMS, when you submit 1,600 pages, it takes awhile 13 for them to process that.

14 Going forward, submission using the 15 electronic information exchange may reduce those 16 delays. I know that, Carolyn, you've expressed some 17 difficulties using that system, but I can provide you 18 a contact that can help you provide documents in that 19 form. So just --

20 MS. HAASS: So is, I'll put it this way.

21 If you begin to do that, you have restrictions and 22 limitations. Because it is a very archaic system.

23 And because of that, the granularity of 24 graphics and pictures would not be coming out 25 appropriately. And it just absolutely made no sense.

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87 1 And we had a lot of difficulty with your 2 system that we would have two different files, exactly 3 the same thing, one would be accepted and one 4 wouldn't. And we couldn't figure out why.

5 And it was taking too much of our time.

6 That's why you saw the first part tried to be 7 submitted twice. Because we couldn't get it through 8 the electronic system.

9 You have a graphic capability of 300dpi.

10 Our logo is more than 300dpi. And it's on every page.

11 It just isn't worth our time.

12 MR. LYNCH: I believe the 300dpi is a 13 minimum, not a maximum.

14 MS. HAASS: No, it's maximum. I mean 15 there's some real difficulties. And we have a premier 16 person who does our documents, and I'm going to tell 17 you, it is one of the more difficult systems that 18 we've ever had to use.

19 MS. GAVRILAS: So --

20 MS. HAASS: You know, I don't want to take 21 this meeting over with that, and we can discuss it 22 later, but --

23 MR. FOWLER: This is an area, so fully 24 understand the dates. We're well aware of the dates.

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88 1 the difficulties differently from the way the NRC 2 characterizes the difficulties of receipt.

3 I think we can summarize this, that this 4 is an area that is, we should better understand 5 whether this can be improved. Because we sit here 6 today with another stack of paper, to respond to RAIs, 7 because of my teams perceived inability to work with 8 the electronic submission system. That's a problem.

9 Now it could be us, it could be the 10 system. But let's take it off and figure out how to 11 fix that.

12 MS. GAVRILAS: Just a point of 13 information. Quick one. The system is designed the 14 way it is because the intent of the system was to 15 enhance transparency. So that the documents can be 16 viewed on the processors that were prevalent at the 17 time at which it was deployed.

18 MS. HAASS: Right. And that was the 19 issue.

20 MS. GAVRILAS: So it was an optimized --

21 MS. HAASS: Right.

22 MS. GAVRILAS: -- optimized two aspects of 23 our mission. One is, openness, reached the broadest 24 set of stakeholders. And the other one is, making it 25 easier for our stakeholders, for another set of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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89 1 stakeholders, the applicants and licensees to use.

2 MS. HAASS: Right. I mean it is a catch-3 22, but we also had to get to a point where we did it 4 the easiest for us because it would, you know, if you 5 have to take every graphic out and do everything 6 individually and save it individually, it becomes so 7 cumbersome that you will make more mistakes.

8 So we can look into it, you've heard my 9 comments on your system, and there's lots of room for 10 improvement on that side as well.

11 MS. GAVRILAS: Noted.

12 MS. YOUNG: Well perhaps we can get them 13 in touch with or possibly with somebody can stop in 14 today and just give a general explanation of the 15 electronic filing.

16 MS. HAASS: We --

17 MS. YOUNG: Because my understanding is, 18 not only do people submit by transmitting 19 electronically, but they also put information on the 20 CDs. But if the CD files meet the format, it can be 21 easily put in.

22 And applications like --

23 MS. HAASS: We do put a --

24 (Simultaneously speaking) 25 MS. YOUNG: -- requirement.

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90 1 MS. HAASS: We've tried the CD submission.

2 But, you know, we have talked with them. We can do 3 that more in the future.

4 MS. YOUNG: Because I know you're 5 interested in saving time. And any unnecessary --

6 MS. HAASS: Yes, but we're not going to 7 solve either problem today.

8 MR. BALAZIK: I think this is a good spot 9 to take a quick break. Next we'll go into Part 70.

10 So ten, 15. Let's take a 15 minute break 11 and start at 10:30. All right, we're going to go mute 12 on the phone and we'll be back at 10:30. All right, 13 thank you.

14 (Whereupon, the above-entitled matter went 15 off the record at 10:14 a.m. and resumed at 10:33 16 a.m.)

17 MR. BALAZIK: Good morning. This is Mike 18 Balazik again and we are going to resume the public 19 meeting.

20 Right now we are on Slide 36, the NRC 21 Licensing Process. This is, we're going to be 22 discussing Part 70 and I'll turn it over to Dave 23 Tiktinsky.

24 MR. TIKTINSKY: Okay. Thanks, Mike. I'll 25 kind of make a point, my presentation is generally NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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91 1 more, you know, general Part 70, but I have a couple 2 of things that came up from this morning's discussion 3 that maybe will help sort of set the frame.

4 Some of it is some of the keys to 5 effectively, at least on the Part 70-type things, is 6 making sure there is a good understanding of 7 applicable regulatory requirements.

8 So we talked a lot about RAIs, that's sort 9 of the finer thing after you submit something, but in 10 the case of Part 70 is making sure you understand the 11 requirements and if you, you know, if you understand 12 them then obviously when you submit an application 13 related to those things you'll be able to, you know, 14 hit the mark better.

15 And, of course, if there are any specific 16 questions related to applicability of specific 17 sections of Part 70, how it gets implemented, then, 18 you know, the form of pre-application, public meetings 19 that we've had on other things for the Part 50 part, 20 you know, may be appropriate.

21 So that's some other ways of making sure, 22 you know -- You know, a lot of the discussion was, you 23 know, you give us a quality application, well in the 24 CP you have already given us an application, so 25 whether, you know, maybe you would have done something NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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92 1 different in the future, it doesn't really matter now 2 if that's already there.

3 For other future applications you can take 4 a lot more of that into account of the experiences 5 that you'll have with the CP as well as the other 6 experiences that we talked about for other facilities 7 to try and make sure, you know -- You know, the best 8 way to minimize, you know, RAIs is to hit the mark as 9 much as you can.

10 So just sort of to get started on Slide 11 37, just a little bit about Part 70 requirements. You 12 know, Part 70 is relatively brought up if you have 13 broad regulation to cover a whole bunch of different 14 things and it talks about, you know, establishing 15 procedures for issuance of licenses, you know, to 16 title to own, acquire, deliver, receive, possess, use, 17 and transfer.

18 So that's a quite a lot of different that 19 it covers. There is a lot of activities that are in 20 there related to, you know, possession and use. There 21 is the scrap recovery and licensing a fuel cycle 22 facility.

23 So that's, it's a -- Again, it's a fairly 24 broad regulation to cover a lot of types of facilities 25 and activities for special nuclear material.

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93 1 The next slide, Slide 38. It's a good 2 example here of, you know, kind of in parallel to what 3 Steve talked about in Part 50, and these, again, not 4 to, tend to be comprehensive, you know.

5 The regulations in 70.21 what the 6 application should be, how to file it, that, again, 7 emphasize the fact that you can incorporate 8 information by reference.

9 So if there is information that you 10 already provided for your other parts of the facility 11 you don't need to repeat them, you can just reference 12 them.

13 Again, the clarity of those references 14 helps the reviewers a lot, you know, the use of 15 crosswalks, tools, you know, whatever is efficient.

16 We want to make sure that the reviewers 17 know where the information is, know how to find it, 18 find it quickly, you know, and shows how it meets 19 those particular regulatory requirements.

20 It also has allowance to, if in Part 70 in 21 70.21(b) that you can have other licensed activities 22 specified in regulation, as long as the specified 23 regulations are met.

24 So, again, it's the combining of 25 applications and licenses. It's not just in 50, it's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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94 1 in 70, it's in other parts, so you are allowed to do 2 that.

3 Again, the biggest emphasis that I will 4 have on that is regardless of the form that it turns 5 out you need to be able to demonstrate that the 6 regulatory requirements are met and the clearer that 7 is demonstrated the easier it is to get through the 8 review process and then timeliness for that.

9 70.22, the content of applications, there 10 is various requirements in there. 70.23 talks about 11 approval, so, you know, 70 is a little different than 12 50, the requirements are somewhat different, the 13 findings are different, but they are sort of still in 14 parallel to the, you know, public health and safety.

15 So it's the same theme even if some of the 16 details are different. I think related to criticality 17 accidents, for example, you know, criticality 18 monitoring systems and the applicability of, you know, 19 subpart (h) which has additional requirements for 20 certain types of licenses authorized to possess 21 critical mass and material.

22 The next slide, Slide 39. So NUREG-1520, 23 which is the standard review plan that we use for a 24 fuel cycle facility license application, the first 25 thing to think about is the information that's in 1520 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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95 1 shouldn't be, you know, that much different than what 2 you've seen in 1537, the augmented ISG, because a lot 3 of that was taken from 1520 and some of it just copied 4 for the applicable portion so a lot of it is the same 5 types of methodologies that you would use for the Part 6 70 application under 1520 or already in 1537.

7 So it's not like you would have to 8 demonstrate using different approaches for Part 70, 9 it's the same approaches and then -- or 1520. Again, 10 the regulatory findings that are discussed in 1520 11 talk about Part 70 regulatory findings.

12 The regulatory findings in 1537 talk about 13 the regulatory findings for Part 50. So that's sort 14 of where the difference the staff in its review of 15 Part 70 applications has to make Part 70 findings for, 16 so it's sort of, you know, tailored to the specific 17 regulation.

18 The document, you know, provides guidance 19 to the reviewers, perform safety environmental 20 reviews. Again, you are not required to follow what's 21 in there, you can propose alternatives with 22 justifications, certainly perfectly acceptable.

23 Things that are usually smooth, if you're 24 trying to go, you know, veer a lot from what's in 25 there and you have to prove it, and your case may be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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96 1 difficult, it may take more time.

2 Again, it's not a definite on that. It 3 is, again, depending upon what it is and what is your 4 approach and what's appropriate for your particular 5 facility.

6 Following formats that match something 7 that we recognize are easier. Again, the easier we 8 have to track the information that we need, the easier 9 the review goes.

10 It also provides guidance for various 11 things, you know, new facilities, amendment renewals, 12 a lot of different activities, but the activities are 13 similar to the things that you are doing under, in 14 Northwest.

15 So it's not a foreign -- 1520 relates very 16 directly to the kinds of things that you are doing 17 that would be in your application, so a lot of it is 18 applicable.

19 It also makes references to other NRC 20 guidance documents, some of them like 1513, which 21 relates to the ISA, Integrated Safety Analysis 22 Guidance, which, again, what's in 1537 refers to the 23 same to documents, so, again, it's not a foreign 24 concept of what it is referring to.

25 The next slide, Slide 40. So sort of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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97 1 purpose of, you know, why we even have an SRP it's, 2 you know, if you have a, it's across the board for 3 quality uniformity of review.

4 We want -- It's guidance for the staff of 5 what they should be looking for and how it should be 6 looked across various facilities so we treat everybody 7 the same regardless of what type of facility it is.

8 At least in uniformity the review would be 9 the same even if the information may be different 10 based on specific requirements in the regulations for 11 a specific type of facility.

12 Again, it's the guidance related, it's 13 meeting the underlying objectives and the regulatory 14 requirements, so there is more information in there.

15 Again, if you look at the regulation it talks about 16 the kinds of things you have to do.

17 The idea of having the SRP is to give more 18 guidance and details of some of the kinds of 19 methodologies and approaches that the staff would find 20 acceptable.

21 As I mention this flexibility, you don't 22 have to follow it, but you have to, you can provide 23 alternatives and also address it as, you know, Part 24 20, Standards of Radiation Protection, and Part 70.

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98 1 different than Part 50 is, you know, the chemical-2 related hazards that are considered in Part 70 based 3 on the nature of the activities that are done under 4 Part 70 facilities.

5 Next slide, Slide 41. So the guidance 6 that we have in the regulations of 70.31 for issuing 7 a license, so once we determine that all the 8 applicable regulatory requirements are met we can 9 issue a license in the form and then you will have 10 conditions as appropriate.

11 You know, conditions, for example, may 12 relate to, you know, you have to A, B, and C before 13 you can have material. There may be other things.

14 Again, as we do the review and we see where you are 15 there may be specific requirements of things that we 16 would put in in the license conditions.

17 We have done this for other facilities.

18 Again, it's not different than any other fuel cycle 19 facility. If you look at other fuel cycle facility 20 licenses you will a series of some standard conditions 21 and then other ones that are specific to that 22 facility.

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99 1 that you find in there.

2 So then we would -- Again, if it was one 3 piece of paper you would still find the same technical 4 conditions, license conditions in that piece of paper.

5 Next slide, Slide 42. So, you know, how 6 does the applicant demonstrate, and let's say that the 7 regulatory requirements are met, we talked a little 8 bit earlier about, you know, how you do that. So you 9 can, you have a choice.

10 You can combine it with the Part 50, 11 Production Facility Applications, in the case it could 12 be the OL. Again, where it's not specific of exactly 13 when you would submit that document you could do it as 14 a standalone document. Again, you choice.

15 The key thing, again, I'd like to emphasis 16 is you have to demonstrate the regulatory requirements 17 are met and if you are going to use multiple 18 applications in different places then, you know, the 19 easier you make it for the staff to know where those 20 requirements are found the easier the review will go.

21 MS. HAASS: Will you be doing a separate 22 safety evaluation report from 70 to 50 even if it was 23 combined, if it's separate you would do them 24 separately, if it was combined would there be one?

25 How would that work within the NRC?

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100 1 MR. TIKTINSKY: Well part of it is, and 2 exactly where and how many documents sort of depends 3 upon how you submitted it to us, but we --

4 MS. HAASS: But it was combined?

5 MR. TIKTINSKY: We would have to make, our 6 SER would have to make combined regulatory findings if 7 we were making the regulatory findings on the Part 50 8 side.

9 MS. HAASS: Okay.

10 MR. TIKTINSKY: We would have conclusions 11 for the Part 50 part. We would have to make 12 regulatory conclusions in the same document for the 13 Part 70 part.

14 So we would have to make sure we had them 15 all in there, that they were comprehensive. So just 16 like you would need to demonstrate that you met all 17 the applicable regulatory requirements, our SER would 18 talk about the staff's acceptance, the reasonable 19 assurance, for all those regulatory requirements.

20 MR. FOWLER: More pertinent to the 21 previous conversation is does one pathway offer an 22 easier, faster schedule than the other pathway?

23 MR. TIKTINSKY: It's hard to say in terms 24 of the speed. Clearly, the easier you can make it on 25 us to understand what you are doing and, you know, not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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101 1 -- Again, I should say, if there is a long time period 2 between submittals of one and the other then, you 3 know, tech reviewers that reviewed one part have to go 4 back and look at it to make sure they have covered it.

5 So there is some efficiencies in having 6 the same people looking at both aspects at the same 7 time. So I know about that --

8 MS. HELTON: If we go ahead a couple of 9 slides I think we're going to get to that, too, but 10 Dave is also going to talk about the differences 11 between the 2-step Part 50 license and the 1-step Part 12 70 license.

13 So Part 70 is a 1-step licensing process, 14 so there are some differences and the key I think is 15 ensuring that whenever you seek to fulfill the 16 requirements of Part 70 that you provide all the 17 information.

18 MS. HAASS: Right.

19 MS. HELTON: There is different -- You 20 know, you have seen that the bar for the construction 21 permit, it's a different bar, you don't have a design 22 set and --

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102 1 to two because we have to have all of our finalized 2 design complete for the operating license under Part 3 50, which is then a 1-step process because the first 4 step has been complete, or we submit it under Part 70.

5 So if I make my question more precise, is 6 there a difference between providing the same 7 information, meeting all the regulatory hurdles under 8 the operating license for Part 50 in contrast to a 9 separate application on your Part 70?

10 MS. HELTON: It might be helpful to step 11 forward in the slides and see if we don't address 12 that.

13 MR. TIKTINSKY: Okay. Yes, see if we go 14 through and see if I answered the question or not.

15 MS. HELTON: Yes.

16 MR. TIKTINSKY: How about that?

17 MR. FOWLER: Okay.

18 MS. HELTON: Sure.

19 MR. TIKTINSKY: So, and, again, just the 20 thinker that if they are combined then we need to make 21 sure how they are met so it's clear to reviewers.

22 Forty-three. So to sort go with what we 23 have looked at, so from what we have received in the 24 docket so far the staff doesn't believe we have 25 sufficient information to do the conduct review of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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103 1 target fabrication scrap recovery activities right 2 now. So I think --

3 MS. HAASS: But it was never expected to 4 be at that level.

5 MR. TIKTINSKY: Yes. So it's just that, 6 that's my understanding that there was not.

7 (Simultaneous speaking) 8 MS. HAASS: Yes.

9 MR. TIKTINSKY: We just want agreement 10 then, we all agree that there is not, we don't believe 11 there is sufficient information.

12 And from our review of those activities, 13 you had mentioned in your application that you 14 believed they were under Part 70, so how we look at 15 them they, I guess the first part is they don't appear 16 to be covered by Part 50, so that's sort of, it's not, 17 it doesn't meet the definitions of production facility 18 under Part 50 and they appear to be subject to Part 19 70.

20 So that's sort of our looking at what --

21 Even, again, you have not submitted the application, 22 so it's hard for us to make a definitive, you know, 23 determination of what is there without that, but 24 that's what we believe at this time.

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104 1 the safety review and issue a license, because 2 obviously you would need to submit an application 3 meeting all the regulatory requirements.

4 And the burden is always on the licensee 5 to demonstrate that they, or the applicant and the 6 licensee to demonstrate that they meet regulatory 7 requirements.

8 The staff does findings of reasonable 9 assurance that you do meet them to protect the public 10 health and safety, but the burden is on the applicant.

11 Sort of in addition to or in lieu of for 12 some specific licensing questions related to, you 13 know, specific aspects of what's applicable, you know, 14 we talked we talked about pre-application meetings.

15 We would like to know, you know, if you 16 believe certain parts of Part 70 are applicable or not 17 applicable and have why they are not applicable we can 18 have pre-application discussions of them.

19 Again, going back to my first point of 20 making sure there is a good understanding of things 21 because for any facility pretty much in, or activity 22 in Part 70, there are some parts that apply and some 23 parts that don't apply just on the nature because Part 24 70 is a broad regulation.

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105 1 facilities, which is different than, you know, uranium 2 enrichment facilities, so there -- But the regulation 3 is written broadly, so, you know, your understanding 4 of what you think you need to meet, having discussions 5 on that would probably be useful to make sure we were, 6 you know, had some alignment, you know.

7 We don't want to play the bring me rock 8 where you just, you know, send something in and we say 9 no, you missed the mark, so we want to have those 10 discussions because there where you add to timeliness, 11 or had the time to doing a review if you do that.

12 So, you know, as we have mentioned, you 13 know, many times those communications and 14 understandings are really important to make sure we 15 hit the mark.

16 But, again, it is, you know, Northwest's 17 responsibility to demonstrate what they think they 18 meet, what you think activities apply, what 19 regulations do you think you meet, and how are you 20 going to demonstrate that they are met.

21 The Slide 44 talked a little bit about 22 schedule and, you know, Steve had presented a schedule 23 to you, and that was a very good outline of the types 24 of activities that get done in a review, so what I 25 present here is sort of, you know, if you were just NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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106 1 submitting a Part 70 application this is what we would 2 tell you that, you know, it's typically about 18 3 months to do a review.

4 We do a technical review of the 5 application. Again, whatever it was, if it was 6 submitted with the Part 50 or not we will do a 7 technical review of the applicable regulatory 8 requirements, issue additional requests for additional 9 information, draft a safety evaluation report, you 10 know.

11 There is slight differences in terms of, 12 you know, the process and terms of, you know, there is 13 not a mandatory hearing for this type of facility in 14 Part 70 compared to 50, so there's some, you know, 15 subtle differences.

16 But I guess the major point here is the 17 review can be done in parallel or a series, so it sort 18 of depends when you submit it.

19 So the 18 months I show here, you know, if 20 you wait until after you submit it and we reviewed an 21 operating license application under Part 50 then you 22 sent us one then that clock would start when you 23 submitted it.

24 If it's with it then we could do that 25 review in parallel, so it wouldn't be adding to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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107 1 time.

2 So, again, a lot of it depends upon where 3 you want to submit it, what is strategic, you know, 4 for your company, when you think you are ready to have 5 all the requirements.

6 And, again, in Part 70 the 1-step license 7 requires, you know, a further development of things 8 than a construction permit and it is also slightly 9 different than what's in an operating license.

10 Again, the regulatory requirements are 11 different so it doesn't necessarily line up 100 12 percent but it is your choice to, when your 13 information is available, that you think you can meet 14 to demonstrate the Part 70 then you can submit it.

15 If that happens to be with the operating 16 license that's perfectly acceptable to us. If it 17 happens to be before or after, I mean, again, that's 18 acceptable, you know.

19 Again, the key is to make sure that, you 20 know, you have an application that's complete, that 21 has all the applicable regulatory requirements 22 addressed.

23 MR. LYNCH: And just to add on, and I 24 think Dave is absolutely right. I guess what it comes 25 down to, I'm glad we're in agreement on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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108 1 information itself that needs to provided and I think 2 that the main comment in terms of what's more timely, 3 the sooner we have the information the sooner we can 4 begin reviewing it, if that helps you in planning when 5 you submit.

6 But I think from a Part 50 standpoint it's 7 important to think about, also, that is there still 8 related activities that are happening under the same 9 roof.

10 So in order for us to make our safety 11 findings under Part 50 for a production facility we 12 will be interested in how other activities happening 13 within that building could impact, and I'm sure it's 14 the same going both ways.

15 So while you can submit the information 16 whenever you would like to, it's all related and we 17 need to know the impacts that those activities will 18 have on the different, within the building on the 19 different other activities that are happening as well, 20 and whether it's the manufacturing of the targets or 21 the processing of those targets.

22 MS. HAASS: Well and that was the concept 23 of our Part 1, Part 2 submission was we showed an 24 overall facility, because you are trying to show all 25 the safety-related activities, you know, and how they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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109 1 interact with one another.

2 MR. LYNCH: Yes.

3 MR. TIKTINSKY: Yes, it sort of emphasizes 4 --

5 (Simultaneous speaking) 6 MS. HAASS: But I can't do one without the 7 other?

8 MR. TIKTINSKY: Yes, to emphasize Steve's 9 point, I mean we, you know, individually look at the 10 Part 50 portion of the facility we need to consider, 11 you know, an external, which isn't really external in 12 this case because it's maybe the room next door.

13 But you still have to consider those 14 activities in the Part 70 one and on the 50, and just, 15 and the same way we would, if you were just looking at 16 just the 70 piece in isolation we would be interested 17 in the impacts of what the Part 50 facility around it 18 was impacting on that in terms of, you know, accidents 19 and analysis and things like that.

20 So we would look at it both ways because, 21 again, we have to make a regulatory finding for those 22 specific parts of the facility for those parts.

23 MR. JOHNSON: So, Nick, did that answer 24 the question that you asked a couple slides back about 25 are there efficiency -- What a thought your question NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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110 1 was, are there efficiencies with going one route 2 versus the other, submitting a separate standalone 3 Part 70 versus incorporating all of the, how you are 4 satisfying all of the requirements into the CP, is 5 that what you were asking?

6 MR. FOWLER: Yes. And, further, is there 7 a material difference between the strategy of 8 application submission?

9 And what I concluded from the conversation 10 there is not a material difference between submitting 11 under a construction, or an operating license out of 12 Part 50 in contrast to a separate and distinct Part 13 70, the same steps, that it's not going to be easier 14 for the NRC.

15 In many companies it would be easier to 16 have a separate Part 70 application because some of 17 the conversations could be more easily 18 compartmentalized even though they do relate to other 19 things.

20 What I concluded, rightly or wrongly, 21 there is not a material difference. And to be clear 22 from what's in my head there is a 2-month difference 23 right now between the critical path of us entering the 24 supply chain with quantities of moly under Part 50, a 25 2-month slip on the Part 70 puts Part 70 on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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111 1 critical path. That's how tight these two things are 2 together.

3 Plugging in all of the assumptions from, 4 well the guidance that we receive from the NRC, there 5 are only two months difference right now and so if 6 there were a material difference in review process 7 cycle time it could very easily affect the entrance of 8 this critical isotope into the supply chain.

9 That's how granular -- I manage the 10 schedule. We're down to a month.

11 MS. HELTON: So I think, you know, we've 12 emphasized the importance of communication on both 13 sides. You know, you want the frequent public 14 meetings, we can do that.

15 And I think what would be really helpful 16 is to have a public meeting or a series of pre-17 application meetings where as you solidify your plans 18 for your operating license and meeting the Part 70 19 that, you know, you keep us in the loop about how your 20 project plan is starting to -- and we don't need 21 those, necessarily all the details, but just in terms 22 of what you are thinking about how to meet the 23 requirements and going forward.

24 I've seen another complex application, I 25 was in operating reactor licensing before this job, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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112 1 where, you know, we've had as many or seven or eight 2 pre-application meetings to talk about each of the 3 different technical chapters and what they're going to 4 be doing to meet the requirements, and you might want 5 to consider doing something like that just so there is 6 no surprises.

7 MS. HAASS: And we have done that in the 8 past.

9 MS. HELTON: Yes.

10 MS. HAASS: Yes, so --

11 MS. HELTON: Yes.

12 MS. GAVRILAS: So just one reminder. This 13 is Mirela again. Just one reminder that these are 14 estimates, the timelines, and we try to walk you 15 through the parameters, that impact held with that 16 estimate that --

17 So it's almost like you are talking 18 project management, what we visualize in our mind is 19 sort of Gantt chart with the end in mind, you know, 20 how the review of these various activities basically 21 lead towards the point that which you get an operating 22 license.

23 MR. BALAZIK: This is Mike Balazik. Is 24 there any other questions on the Part 70 piece, 25 because now we're going to shift to something else?

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113 1 MR. ADAMS: And now for something 2 different.

3 MR. BALAZIK: All right, Al.

4 MR. ADAMS: So what I'd like to do is, you 5 know, we have discussed the, you know, general 6 requirements for licensing, your proposed activities, 7 you know, we discussed where the current status 8 review.

9 Using your cover letter for Part 2 of the 10 application and the NRC reply I'd like to try to pull 11 everything together and hopefully the goal here is to 12 reach a common understanding of how to move forward.

13 I am, you know, because of the excellent 14 presentations that came before me, you know, some of 15 this, you know, some of what I am going to say will be 16 redundant, but, again, repeating it in the light of 17 your application requests.

18 So, next slide. So, you know, here is I 19 think probably the most important statement from, well 20 one of the important statements from your cover 21 letter, that you are applying to the NRC to obtain a 22 license for a production facility under 10 CFR Part 23 50.

24 So, next slide. So I think, you know, we 25 understand that statement that you are looking for a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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114 1 construction permit for a production facility, you 2 know, to dig a little bit deeper that you are looking 3 for a license to construct a facility where you plan 4 to conduct activities to separate moly-99 from 5 irradiated uranium and other byproduct material.

6 That's consistent with the third 7 definition of production facility in 10 CFR 50.2.

8 There is three basic definitions of production 9 facility.

10 One is facilities that are involved in the 11 formation of plutonium, basically plutonium production 12 reactors. The other one are facilities that are 13 primarily separating plutonium, and there is the third 14 definition which is on the slide, any facility design 15 or used for the processing of irradiated materials 16 containing special nuclear material.

17 (Off the record comments) 18 MR. BALAZIK: This is Mike Balazik, please 19 Star 6 your phone to mute it. We can hear some 20 background conversation.

21 (Off the record comments) 22 MR. BALAZIK: This is Mike Balazik. We 23 are picking up some background conversation. I ask 24 you please mute your phone, Star 6.

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115 1 is a safety reason behind the definition and that's 2 when you are processing irradiated materials 3 containing special nuclear material basically you are 4 separating out fission products from irradiated 5 special nuclear material.

6 That involves additional hazards from what 7 you would see in what I would call traditional fuel 8 cycle facilities, the fact that you are dealing with 9 irradiated material.

10 You are dealing with fission products, 11 radioactive material, gaseous fission products, which, 12 you know, which creates different accident scenarios 13 and potential for dose.

14 So that's sort of the theory and the idea 15 is once you introduce these irradiated materials that 16 your intensity of our Part 50 where we are interested 17 not only in the materials, the licensing of the 18 materials, but also the licensing of the facility that 19 contains the materials.

20 The third definition does contain some 21 exceptions and you have indicated that you are not 22 looking to license under any of those exceptions and 23 those exceptions are that basically your separation is 24 being done on a laboratory scale, so that's the first 25 exception.

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116 1 The other one is if you are, that if your 2 batches are less than 100 grams of uranium then it's 3 not a production facility. You indicated that your 4 batches will be greater than 100 grams of uranium.

5 And the third is that if the irradiated 6 material that the fission product concentrations and 7 the plutonium concentrations are less than the cutoffs 8 in the definition then you are not a production 9 facility.

10 So you indicated that you are not looking 11 to fall under any of those exceptions, which means you 12 are a production facility under Part 50.

13 Next. So here is another statement in 14 your letter to us.

15 (Off microphone comment) 16 MR. ADAMS: Oh, I'm sorry. Yes, that's 17 what it says here. So, I'm sorry, this is our letter 18 back to you where we completed the review and we agree 19 that you have an application for a construction permit 20 for a production facility as defined in 50.2 and 21 you've met the requirements of 2.101(a)(5) and the 22 information required by 50.34 and we found your 23 application acceptable for docketing.

24 So based on that we are going ahead and 25 reviewing the application for the production facility.

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117 1 Okay, now Slide 49.

2 So in your cover letter you discussed your 3 intent to apply for a single part, a 10 CFR Part 50 4 license. You indicated following NUREG-1537 and you 5 also referenced the regulations in 50.31 and 50.32.

6 Slide 50. So just to repeat what 50.31 7 and 50.32 say, so the regulations in Part 50 allows 8 combining of applications under Chapter 1 of 10 CFR 9 and Chapter 1 is all of the NRC regulations, so we, 10 you know, so applications can be combined.

11 And there is a regulation 50.32 and there 12 is a parallel regulation in Part 70, 70.21, and they 13 allow an incorporation by reference information 14 contained in, you know, previous applications, other 15 information. The requirement is that the references 16 are clear and specific.

17 Slide 51. So your cover letter referred 18 to NUREG-1537. I assume that when you say NUREG-1537 19 you are referring to the ISG, that augmented 1537 --

20 MS. HAASS: Correct.

21 MR. ADAMS: -- which provides applicable 22 guidance for licensing radioisotope production 23 facilities and aqueous homogenous reactors, you know, 24 the guidance on aqueous homogenous reactors isn't 25 applicable to your proposed facility.

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118 1 NUREG-1537 has a couple of statements that 2 are applicable to what you are proposing on doing 3 here. Section 9-5 of NUREG-1537 contains guidance 4 that materials used in the production facility license 5 need to meet the regulatory requirements for that 6 material. In other words, special nuclear material 7 needs to meet the regulations in Part 70.

8 NUREG-1537 also says that materials 9 required to operate the utilization of a production 10 facility can be included in the license and this 11 permits the combining of licenses.

12 Fifty-two. So your cover talked about 13 embedded in the 10 CFR 50 license facility activities 14 under Part 70 and Part 30.

15 Slide 53. As I mentioned, as discussed in 16 Section 9-5 of NUREG-1537 the Part 50 license can 17 include other activities, however, the issuance of a 18 Part 50 license doesn't automatically include other 19 activities, other licenses.

20 For example, you know, Part 70, Part 40, 21 Part 30 licenses. These licenses are combined only in 22 the Part 50 license if the applicant has submitted the 23 needed information and the applicable requirements.

24 So I think as we said several times, at 25 this time we don't believe that your construction NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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119 1 permit application has the information required to 2 grant the additional licenses and I think we're 3 looking for a better understanding of what you mean by 4 when you say "embedded activities."

5 Next slide. So this is an example of a 6 Part 50 utilization of an operating license. We call 7 them included activities. What I am looking for is to 8 understand if our included activities are the same as 9 your embedded activities.

10 As you can see in this license the 11 different licensing clauses. Number 1 on this slide 12 that is the license for the facility, so that's where 13 the license is granted for the Part 50 facility. This 14 is an example of a Class 103 license, which is similar 15 to the Class license you are looking for.

16 Where you see the three dots, where you 17 see the dots there and that phraseology, that just 18 listed who the licensees were and for this particular 19 facility there was a very long list of applicants.

20 And so Number 2 is you see an included 21 activity, so you can see this is the Part 70 clause so 22 the included activities to receive, possess, and use 23 at any time special nuclear material, in this case 24 it's reactor fuel in accordance with the limitations 25 for storage and the amounts required for reactor NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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120 1 operation as described in the application.

2 And you can see in Number 3 there is Part 3 30, 40, and 70 license to receive byproduct, source, 4 and special nuclear material falls under other uses, 5 neutron sources for startup, sealed sources for 6 instrumentation, calibration, radiation monitoring, 7 fission detectors.

8 Number 4 is a clause, it's a reactor 9 clause. It's Part 30, 40, and 70, you can see, to 10 receive, possess, and use in any amounts is required 11 in any byproduct source of special nuclear material, 12 so you can see the included activities.

13 C is just a reiteration that even though 14 it's a Part 50 license that the activities under the 15 other parts, 40, 30, 70, need to follow those 16 regulations. So that's how these concepts are put in 17 place in the license.

18 So, 55. You mention that the RPF will 19 include the fabrication of LEU targets which will be 20 licensed under 10 CFR Part 70.

21 Fifty-six. So, you know, we understand 22 that, you know, you understand that the fabrication of 23 targets is under 10 CFR Part 70 as we discussed 24 several times and this was reflected in our docketing 25 acceptance letter which stated that staff expects that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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121 1 and Northwest will submit an application for 2 fabricating low-enriched uranium targets under 10 CFR 3 Part 70.

4 And next is 57 --

5 MR. FOWLER: So I want to --

6 MR. ADAMS: Yes?

7 MR. FOWLER: Al, I I'd just to clarify 8 that.

9 MR. ADAMS: Sure.

10 MR. FOWLER: Part of what triggered a 11 serious of conversations was the meeting immediately 12 preceding Thanksgiving in which our internalization of 13 the communication was a requirement to bifurcate our 14 application between Part 50 and Part 70.

15 I was on the phone and I explicitly heard 16 that there would be a separate requirement for a Part 17 70 application, where previously we had socialized, 18 and I'll use the term socialized because it was only 19 discussed, socialized and put embedded activities, our 20 assumption that everything would be under Part 50.

21 So now 2-1/2, three months later I'm 22 understanding the language differently, which so long 23 as the information is there it can be either under the 24 50 umbrella or separate.

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122 1 license, but, you know, there is choices on how you 2 put in your application, there choices on how the 3 license looks.

4 However, to get from Point A to Point B we 5 need to follow the regulatory lane for that activity.

6 In other words, because I give you a Part 50 license 7 it doesn't automatically spawn these other licenses.

8 The Part 50 license by itself is a, you 9 know, is a license for a very expensive building 10 without, you know, without the other, you know, 11 without possession of material that building doesn't 12 do very much.

13 So I think that's the nuance that I think 14 we kind of missed in the conversations back and forth, 15 and I hope we have clarified.

16 MS. HELTON: Yes. Just to add to that, I 17 agree. This is Shana Helton for the phone. The point 18 I think back at the Thanksgiving meeting that is being 19 reinforced today is that we need to see something from 20 you that demonstrates compliance with the requirements 21 in Part 70.

22 MS. HAASS: There was --

23 MS. HELTON: Right. So I think that's --

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123 1 disagreement with that when we were socializing it 2 when we had originally sent our letter over a year 3 ago.

4 MS. HELTON: Right.

5 MS. HAASS: There was no disagreement on 6 that, but there was a 1-step process versus a two, you 7 know, and, you know, there is a nuance and, you know, 8 we agree with that.

9 I mean what we need to do today is move 10 forward and we understand completeness, we understand 11 compliance, and we will get back with you on how we 12 plan on dealing with the Part 70, if it's going to be 13 combined with 50 or not.

14 MS. GAVRILAS: This is the main objective 15 of this meeting. We need to make sure that all the 16 areas where there is uncertainty, where we are not 17 aligned, today is our opportunity to address them.

18 You know that's why we exchanged the 19 topics that we covered today with Carolyn before the 20 meeting to make sure that everything that we are 21 presenting here does address your concerns and does 22 actually get us to the point to which we can align on 23 the things that have some uncertainty associated with 24 them.

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124 1 everyone's head nodding that we are now in alignment 2 with respect to the previous kind of crosswise 3 communications on 70 and 50 and for that we can 4 successfully tick off that as we have met that 5 objective of the meeting.

6 The second and broader objective of the 7 meeting was to explore how we ensure that we most 8 efficiently accelerate the schedule to meet the needs 9 that we all recognize in the United States.

10 So I appreciate that we can tick off that 11 first objective of the meeting successfully.

12 MR. ADAMS: And I think I have one more 13 slide. Number, I think Slide 57. So that the current 14 application that you are not, at this point you are 15 not seeking an operating license for the proposed 16 facility.

17 This is a discussion we would like to have 18 with you today to the extent, you know, that we can 19 have it as to what your plans are for submitting your 20 operating license application because that does 21 influence timing, that does influence, you know, what 22 we do on, you know, what we need to do and what you 23 need to do, too.

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125 1 prepared.

2 The second point, current application does 3 not request a license to produce SNM for the 4 fabrication of LEU targets, I think we beat that one 5 into submission.

6 MS. HAASS: Well it doesn't, it's not a 7 current operating license application.

8 MR. ADAMS: That's right, it's not.

9 MS. HAASS: It's Part 70.

10 MS. HELTON: Right.

11 MR. ADAMS: Yes. That's right, and that's 12 a separate point from my first one.

13 MS. HAASS: Right.

14 MR. ADAMS: And a facility can have 15 multiple licenses, that a single building can be a 16 place of use under multiple licenses.

17 When I was a licensee my containment 18 building was a place of use under my reactor license, 19 it was a place of use under our NRC SNM license, it 20 was a place of use under a state byproduct license.

21 The important thing, which I think Dave 22 and Steve alluded to, is we need to look to make sure 23 that those multiple activities don't impact the safety 24 of each other.

25 MS. HAASS: Yes.

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126 1 MR. ADAMS: So that's the important thing, 2 but there is no rule that says that, you know, a 3 certain piece of turf can only, you know, can only be 4 occupied by one license, and I think that is 5 consistent with what we have discussed today.

6 So like I said I think the, you know, 7 before the day is out we would like to discuss, you 8 know, what are, you know, your plans for moving 9 forward with your operating license application for, 10 you know, for we understand them and we can be, you 11 know, prepared.

12 That's it for me.

13 MR. BALAZIK: All right. Real quick, this 14 is Mike Balazik again, and I know we have touched on 15 some of these topics but I just want to reemphasize 16 them.

17 On communications, that internal and 18 external communications is important to support a 19 quality and timely application review. I just wanted 20 to go through some of those channels that we have 21 already set in place.

22 One that Shana mentioned early in the 23 meeting about essentially one-stop shopping, that I am 24 your contact even though you've got, down the road 25 there is potential licenses, I am your main contact, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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127 1 and, you know, on a lot of our calls, on our weekly 2 status calls I'll have Dave and Nancy on those calls.

3 The next item, clarifying, calls for REIs.

4 We've done a couple of those for the environmental and 5 we plan to continue those for the safety, sharing 6 those RAIs with you draft form, make sure there is an 7 understanding, and if there is not, you know, we can 8 discuss it and even modify the RAIs so that it is 9 clear.

10 Since we are discussing RAIs I'd just like 11 to share one item for thought going forward. Even 12 though there is no regulatory requirement to update 13 your PSAR, we've seen a good practice, or identified 14 a good practice that if you update your PSAR with the 15 RAIs that that can also lead to a timely review, but 16 even future steps it will help us, to keep your 17 updated PSAR.

18 But realize there is no, you know --

19 MS. GAVRILAS: I'll just mention one 20 thing, ACRS. It's easier for the ACRS, we accept your 21 responses, right, as a supplement to your submission, 22 they become part, they are docketed and they become 23 part of the docket.

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128 1 as possible.

2 We were talking about places where 3 efficiencies can be realized, that's a place where an 4 efficiency can be realized.

5 MS. HAASS: So a good example is the RAIs 6 we have received on Chapter 19. We've already updated 7 Chapter 19. You have not received it, but we have 8 already updated it.

9 We actually when we get them we do it 10 right then and there. I am more than happy to provide 11 you an updated 19 if you want it right now. I don't 12 know why we'd need it right at the moment, but we will 13 be providing a revised PSAR with all the RAIs. It's 14 already in the plan.

15 MS. GAVRILAS: That's terrific.

16 MR. TIKTINSKY: The practice that we find 17 that works a lot is sometimes, you know, answers to 18 RAIs are long but changes to the applications don't 19 necessarily, aren't -- Well you might change one thing 20 in an application and have a 3-page thing backing it 21 up.

22 MS. HAASS: Right.

23 MR. TIKTINSKY: So at the end of the day, 24 at the end of the review it's good to have one 25 application that we know everything that's in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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129 1 application that we can write an SER against rather 2 than writing SERs against all these little sort of 3 sidebar discussions.

4 So, again, as Mike said it's not a 5 regulatory requirement but it's certainly an 6 efficiency that we found in not only 50 reviews but 7 certainly in 70 reviews also.

8 MS. HAASS: But remember it's difficult 9 for us to manage if we don't do that. That makes us 10 inefficient, so it's only good practice on our part 11 and to move forward to the operating license.

12 MR. TIKTINSKY: That could be changed 13 pages, you know. It doesn't have be, you know, every 14 time you make something it doesn't need a whole 15 chapter, it's just whatever related to, you know, the 16 change from an RAI and is, you know, and you manage it 17 however you find most efficient.

18 MR. BALAZIK: All right. Another item, 19 responsiveness, we've also talked about that, 20 especially timely response to RAIs and when we share 21 the draft RAIs if there is something that you see in 22 there that you can't get in 30 days or a certain 23 timeframe just let us know.

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130 1 take us a little bit longer. You know, we just need 2 that communication back and forth that there may be 3 something up there that may take a little bit longer.

4 Quality of submissions, we also talked 5 about this, identifying proprietary information, 6 removing that, and just that answers are complete.

7 Also, just clarify previous communications 8 or socializing. We mentioned this earlier that no 9 regulatory decisions are made in public meetings and 10 that public meetings are not a substitute for 11 submittal of information on the docket and also that, 12 you know, we don't make decisions on our weekly calls.

13 And, finally, just that the NRC has an 14 opening policy and if we chose to close a meeting, you 15 know, it's reserved for information that must be 16 withheld in accordance with our regulation.

17 So that's pretty much it for 18 communications. I don't know if anybody else wants to 19 add -- Yes?

20 MR. LYNCH: I just wanted -- I was really 21 glad to hear that we were able to meet one of your 22 objectives in terms of licensing, that we have a 23 shared understanding that additional technical 24 information is needed for, to meet Part 70 25 requirements and how you choose to submit that is up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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131 1 to you and regardless of how it is submitted it's 2 still the same technical information that we are 3 looking for. I'm glad we've got that objective met.

4 I want to make sure that we can also 5 hopefully meet that second objective that you stated 6 at the beginning, which was exploring mechanisms to 7 expedite the review.

8 I tried making a summary. I think Mike 9 highlighted them and I just kind of want to read 10 through those again and make sure that we understand 11 everything you are looking for and to reiterate our 12 points that can help facilitate that expedition.

13 One of those areas we've talked a lot 14 about, RAIs, trying to reduce the number of rounds of 15 RAIs and even the total number of RAIs, things that 16 can go that, the quality of your responses, 17 completeness and the timeliness, we explore different 18 ways of communicating that to help facilitate that.

19 Mike has his weekly status calls. We have 20 talked about -- and on the status calls we can make, 21 talk further about if we want to set up standing 22 public meetings. If that can help we can certainly 23 get those set up as well.

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132 1 identify problems you see coming down the road that 2 we, both parties can be thinking about and, you know, 3 maybe it's not something we address immediately, but 4 at least we can put them on the list of things NRC 5 needs to think about and things that Northwest needs 6 to think about, and they can topics of future public 7 meetings.

8 We can also talk about, you know, email 9 communication works, too, send emails. You can update 10 and propose topics that we can have on those weekly 11 calls, topics for public meetings, if we can get 12 those, and it helps, too, we can discuss ahead of time 13 before we have those calls.

14 Al touched on this, also that's important 15 to us is updates to your schedule. This can be 16 updates as Mike was talking about with responses to 17 RAIs.

18 If it's going to take you a little bit 19 longer to get certain responses to us work that out 20 with Mike, let us know what's going on with your 21 schedule so that we can plan and make sure that we 22 have people available and ready to review your 23 responses when they come in.

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133 1 license application, helping us have a good idea of 2 when that's coming in to make sure that we have people 3 ready to review it when it comes in.

4 So letting us know delays that might come 5 up or if your schedule is getting pushed up, it helps 6 us align our budget and our resources to make sure 7 that we are ready for your application.

8 We also talked about pre-application 9 meetings. So when you are getting ready to submit 10 your next application for your operating license we 11 can have meetings ahead of that submission to make 12 sure that we have a shared understanding of the 13 information that's coming in that and have discussions 14 about that so it helps encourage that a quality 15 submission comes in for your operating license and 16 could help potentially reduce that review time as 17 well.

18 In talking about the operating license 19 application I wanted emphasize again, because 20 ultimately we complete this construction permit review 21 in our 18 to 24-month timeframe, we're still 22 anticipating an additional 18 to 24-month review for 23 the operating license application, and I understand 24 it's critical that we can get that review done 25 efficiently as well.

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134 1 So I think for those exploring, those pre-2 application meetings can be a good way of getting us 3 started on that review and knowing when it's coming in 4 can help us be prepared.

5 We highlighted following the guidance.

6 You can gain insight from NUREG-1537, the ISG, our 7 standard review plan, so you know exactly what the NRC 8 is looking for when we review the application that you 9 sent in, also looking at past applications that have 10 come in to get ideas of questions we have asked in the 11 past and the level of detail of information that we 12 found acceptable in the past.

13 We also talked about reducing 14 administrative time so that we don't have time that's 15 spent with people not doing anything, and I think 16 that's good and I think those weekly calls, again, are 17 going to be crucial to reducing that administrative 18 time for processing.

19 And Mike highlighted again at the end 20 updating the application as you are responding to 21 RAIs. That was my list. Were there other things that 22 I missed that we can --

23 MR. ADAMS: There's probably one I want to 24 touch on. I think I touched on it briefly and that's 25 the operating license application.

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135 1 The last research reactor that we licensed 2 submitted a complete application at the construction 3 permit stage so our review was for both the 4 construction permit and the operating license at the 5 same time.

6 Obviously, that has the potential to, you 7 know, reduce the review time significantly so that's 8 why we are interested in knowing what's your timing on 9 your operating license that, you know, that has an 10 effect because, you know, the theory is that the 11 construction permit you've given us so much of, say, 12 you know, your complete design that you've given us so 13 much of that design and, you know, there is enough 14 there to make a decision to allow the facility to be 15 constructed and then the rest of the details on the 16 design come in with the operating license that, you 17 know -- so there is a lot of variability what that, 18 you know, what those parts, you know, what those two 19 parts look like.

20 The first part is here, you know, what 21 needs to come in to fill and, you know, to fill in the 22 rest of the information and when that information is 23 coming in I think is important, you know, in the 24 discussion of, you know, how to change the, you know, 25 the timing of this and, you know, not only, you know, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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136 1 talking talk the timing from, you know, the beginning 2 to you have an operating license.

3 MR. TIKTINSKY: If I add a little emphasis 4 from Steve's point on the Part 70 side, you know, 5 there is many examples of the kinds of the RAIs that 6 we have asked for Part 70 applications as well as 7 SERS, so you can sort of see when we write up things 8 related to 1520 what the kind of things we're looking 9 for, the kind of questions we had.

10 And, also, you know, emphasizing of the 11 use -- You've got multiple things here, the use of 12 crosswalks, you know, again, the clearer that you can 13 make it that we understand where the information is 14 the easier it will be for the reviewers to get the job 15 done and minimize questions of because we just can't 16 find information.

17 MR. FOWLER: So to the list that Steve 18 summarized very nicely I would add a program/project 19 management process, just as I manage a program inside 20 of a private company I have far less insight into the 21 detailed activities in what's happening at the NRC and 22 whether we're on track, off track, what are the 23 constraints, what are the barriers, those kinds of 24 things.

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137 1 management structure I think is very, very important 2 to keep things on track.

3 MS. HAASS: Yes.

4 MR. LYNCH: And I think to that, yes, I 5 think it's very important from both sides to keep each 6 other updated on where we are at in our reviews and I 7 think with the calls we can do that.

8 Also, what we're going to try doing is, 9 you know, keep you updated on our overall review 10 schedule. We have this initial review schedule that 11 we shared here today on our slides, but as things come 12 up that may necessitate that changing, either 13 expedited or delays, we need to communicate that to 14 you as soon as possible, and that's a commitment that 15 we can make as well.

16 We are also going to, you'll be seeing 17 shortly, we're working on developing a public website 18 that should be going live in the next couple weeks 19 that you can be able to also have all of your 20 application data displayed as well, that can be easily 21 accessed and see our review schedule.

22 MR. ADAMS: The public --

23 MS. HAASS: The public would -- Sorry.

24 For Northwest Isotopes or for other things as well?

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138 1 and general moly-99.

2 MS. HAASS: Okay, got it.

3 MR. ADAMS: And your public information, 4 not your --

5 MS. HAASS: I understand.

6 MR. LYNCH: But, yes, and, you know, as we 7 continue with the review I'm sure both sides will have 8 new ideas.

9 MS. HAASS: Yes.

10 MR. LYNCH: So chair them and we can 11 continue to improve.

12 MR. BALAZIK: All right. At this point 13 we're a little ahead of schedule. Our senior managers 14 want to come down for our closing remarks and summary.

15 The timeframe for that is 2:30, but I 16 wanted to ask Northwest if they had additional 17 discussion they want to do in the afternoon on any of 18 the topics we presented, any topics that we didn't 19 present today that they would like to discuss in a 20 public meeting. I've got that scheduled for 1:30 and 21 lasting about an hour.

22 MS. GAVRILAS: Yes, I have a suggestion, 23 that we mull over everything we have heard and perhaps 24 after lunch we reconvene and that will be the time, 25 unless you want us to research something over lunch.

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139 1 It's going to be after lunch we reconvene 2 and we sort of discuss any outstanding items, how's 3 that?

4 MS. HAASS: That's fine.

5 MR. FOWLER: Sounds good.

6 MR. ADAMS: And another question, is, you 7 know, giving us information on where you see your 8 schedule moving forward, you know, especially giving 9 us the operating license application, is that 10 something that you are prepared to talk to us today in 11 this swarm or --

12 MR. FOWLER: We would certainly be 13 prepared to respond and provide some answers in a non-14 public format, as it's dependent upon a lot of the 15 questions that were asked of us that are of a 16 proprietary nature to come up with the anticipated 17 scheduled.

18 MR. ADAMS: Okay.

19 MR. BALAZIK: Okay.

20 MS. GAVRILAS: Enjoy lunch.

21 MR. BALAZIK: Yes.

22 MR. ADAMS: What time --

23 MS. GAVRILAS: We'll reconvene at --

24 MR. BALAZIK: Well let's reconvene at 1:30 25 for discussion of additional topics and then at 2:30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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140 1 we'll do the closing remarks.

2 MS. GAVRILAS: Yes. And we have an 3 opportunity before the public to --

4 MR. BALAZIK: Yes, we're going to do that, 5 too, yes.

6 MS. GAVRILAS: So we need to stick to the 7 agenda because --

8 MS. HAASS: Is there any opportunity for 9 a non-public portion of this?

10 MR. BALAZIK: No, there is not.

11 MS. HAASS: Okay.

12 MS. GAVRILAS: So we need to stick to the 13 agenda because the agenda is made available so that 14 everybody can listen, so we'll just meet back at 1:30 15 and we'll talk more then.

16 MS. HAASS: Right.

17 MR. FOWLER: Very good.

18 MALE PARTICIPANT: Thank you.

19 MR. BALAZIK: This is Mike Balazik. We'll 20 be coming back at 1:30 and we're going on mute until 21 then.

22 (Whereupon, the above-entitled matter went 23 off the record at 11:32 a.m. and resumed at 1:35 p.m.)

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141 1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2 (1:35 p.m.)

3 MR. BALAZIK: Hi, this is Mike Balazik, 4 and we want to resume the public meeting with 5 Northwest Medical Isotopes. Right now in the agenda 6 we have Northwest Medical Isotope topics. If there's 7 anything that Northwest wants to discuss with the 8 staff?

9 MR. FOWLER: We did not have topics in 10 public form. We'll arrange a separate non-public 11 meeting to discuss some topics.

12 MS. GAVRILAS: Mike, you want to talk 13 about the setting up closed meetings please, because 14 apparently there was some miscommunication on what 15 requirements we must need before we can do that.

16 MR. BALAZIK: Yes, the requirements for a 17 closed meeting is to submit an affidavit with the 18 letter, but with the specific topics that are going to 19 be discussed in the closed forum.

20 So then what we would do is we would look 21 at those topics and agree that yes, these are proper 22 to be discussed in a closed setting vice an open 23 public meeting.

24 So in the affidavit that was provided, I 25 felt that it was very general, and I received some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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142 1 advice that it did not contain sufficient detail to 2 close the meeting.

3 MS. HAASS: And as discussed with you, we 4 were, we didn't quite know what would be in the non-5 public forum because this discussion had to occur and 6 that's why it was general. So it's not that we didn't 7 understand, it was because of how the meeting was set 8 up.

9 MS. GAVRILAS: I understand. So the other 10 thing that we tried to see is if it's okay for us to 11 close a portion of this meeting. So that was the 12 homework we did during lunch. And we were advised 13 that that's not okay because the topics need to be 14 submitted by affidavit. So we tried.

15 MS. HAASS: It's a catch 22.

16 MS. GAVRILAS: Yes.

17 MS. HAASS: But no, we do understand, you 18 know, the requirements for a non-public meeting. But 19 we just didn't have enough data to be able to give you 20 any more specifics.

21 MR. LYNCH: That's understood. Well 22 maybe, if we have some time maybe we could use for 23 time our over here is to maybe make a list of some 24 action items that we can take for going forward, and 25 this could include topics for future meetings that you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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143 1 might like to have, things you would like to see, and 2 other things you would like to go forward on both 3 sides that we can take back and then we can get back 4 to each other on. Does that sound like something you 5 would like to go over?

6 MS. HAASS: I would say we can take some 7 action items. But just as long as we know it's 8 subject to change because, you know, I still have some 9 discussions I need to do.

10 MR. LYNCH: Understood, understood. Yes, 11 this is not meant to commit you to anything. This is 12 intended to help us get an idea of when we leave here 13 today what should we be most focused on, aside from 14 reviewing your application.

15 Mike, did you want to lead with any topics 16 there?

17 MR. BALAZIK: One thing we've discussed 18 before, and again stop me if we're going into 19 proprietary information. But one thing we've 20 discussed in the past is facility design, final 21 design.

22 And what we've talked about earlier are 23 our resources for future applications, future 24 submittals. Is it possible we could get some sort of 25 idea of how far down that path Northwest is?

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144 1 MS. HAASS: I think we can state that we 2 are in the process of finishing our final design. But 3 from a schedule perspective, that would have to be 4 discussed in a closed session.

5 MR. LYNCH: Yes, I think the topic from 6 that is what, something the NRC is interested in 7 understanding better from you is when will your final 8 design be complete, and also how do you think you 9 might consider submitting that because there are 10 different ways that the final design can be provided 11 to the NRC.

12 The final design can be provided as part 13 of your operating license application, or you can 14 amend your current construction permit with additional 15 design information as you finish it.

16 And however you choose to do that is fine.

17 But it does help us to anticipate when that 18 information might be coming in. So that's just, that 19 is a topic that would be useful for us to discuss in 20 the future.

21 MS. HAASS: Well, and I would be 22 interested, because this is the closed question, what 23 have you preferred in the past? Would you like to see 24 it, like, you know, before the operating license 25 submission with the, maybe the finalization of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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145 1 construction permit.

2 I mean, I don't know. I mean, I don't 3 know what's the best timing for you guys I guess I 4 would ask. And then, you know, we'll try and work 5 that into a schedule.

6 MR. LYNCH: I think for us, you know, 7 we're willing to work with you with whichever way you 8 would prefer. You know, we haven't done something 9 like this in a very, very long time. So I don't know 10 if there's a lot of precedent we can necessarily point 11 to.

12 But I think we want to work with your 13 proposal. And by notifying us when it's coming, we 14 can make sure we have the appropriate resources 15 available for that.

16 MR. ADAMS: This is Al. I think, you 17 know, the understanding of the timing is important 18 because we're going to, you know, spend time and 19 effort reviewing what you've given us.

20 And if we're 85 percent complete with that 21 review and all of a sudden we have a whole new bunch 22 of information, it might be advantageous to finish 23 that 15 percent, take that licensing action and then 24 try to reset, try to, you know, blend those two 25 together and start reviewing sort of an expanded NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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146 1 scope.

2 So you know, part of it depends on the 3 timing versus if we're only, like, ten percent into 4 looking at something and the new information comes in, 5 then the effort or cost of changing your direction, 6 changing your scope is minimal. So I think that's an 7 important solution.

8 MR. LYNCH: Maybe that's a better way to 9 capture what we can provide that too. We won't advise 10 you on which way is better than the other. But we can 11 discuss, as Al was going to, what potential impacts of 12 your decisions could be.

13 MR. BALAZIK: This is Mike Balazik. I 14 guess another potential item is exemptions. I don't 15 know if Northwest has looked at any potential 16 exemptions that could come down the road that we could 17 be aware of or could prepare for, just kind of another 18 item that would benefit us in future reviews on 19 exemptions.

20 MS. HAASS: Okay.

21 MR. LYNCH: And even more broadly, just 22 other licensing actions in addition to your primary 23 construction permit or operating license, or material 24 license and application that we might need to consider 25 and the timing. And for example, that could include NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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147 1 the other research reactors that might be seeking 2 amendments to support that, knowing the timings that 3 those licensing actions can help us as well.

4 MR. ADAMS: Another example would be if 5 there's any need for shipping packages that would be 6 unique to what you're doing that, you know, don't 7 exist. That's another part of NRC and that's, you 8 know, a discussion that they have their own timelines 9 for doing that type of work.

10 MS. HAASS: And we've had brief 11 conversations with the other organizations, too.

12 MS. YOUNG: And that's under Part 71.

13 MR. LYNCH: Another topic that, you know, 14 that I think we could discuss going forward to our, 15 we've touched on the topic of potentially setting up 16 standing public meetings.

17 Put that on the list of establishing if 18 that's something that you want to pursue, what you 19 think appropriate frequency for those meetings might 20 be, what topics you might want to discuss during 21 those. I think that, I took that as one of the take-22 always I had from earlier today as a topic we should 23 explore further.

24 MR. BALAZIK: I guess, this is Mike 25 Balazik again, for expectations for interactions with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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148 1 the NRC for the environmental review, we're pretty 2 much had a set process. I mean, is there any 3 recommendations on communications that you would like 4 to see in the future?

5 MS. HAASS: Just want to make sure that 6 the RAIs get reviewed prior to going out final to make 7 sure there's no business sensitive information in 8 there. If you can at all let me know the possible 9 timing when that's going to come in, you know, we have 10 a lot of things going on as well and I need to make 11 sure our resources are there.

12 And I know when we get into the safety 13 aspect it can get more and more difficult, you know, 14 to get those reviewed, and what resources that means 15 to us as well.

16 Also from, Nancy, from your perspective, 17 I mean, you'll have another public-type meeting within 18 the NEPA realm. And you know when you're going to be 19 scheduling that. I know that the City of Columbia was 20 asking me that question as well.

21 I just know, you know, they told me they 22 would really like to help you do that. And I know 23 last time you guys went and did that, you know, 24 independently which is fine, but they're also willing 25 to go help as well. And, you know, you have their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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149 1 contact information now.

2 MS. YOUNG: Okay, thank you.

3 MR. LYNCH: Were there any topics that 4 you've had in mind in addition to that that you would 5 like to focus on in the future?

6 MS. HAASS: No. I think when you start 7 looking at schedule, the other licensing actions and 8 the same in the public meetings, that's really where 9 we want to focus with you guys.

10 Obviously, the standing public meetings, 11 you know, we'll assume that there will be some closed 12 portions of those meetings within that, you know, with 13 the appropriate documentation, understand that.

14 MS. GAVRILAS: Mike, you'll need to 15 elaborate on the process. I think we need the 16 affidavit with sufficient detail --

17 (Simultaneous speaking) 18 MS. HAASS: Oh, that's what I just said.

19 Right, no --

20 MS. GAVRILAS: So that's --

21 MS. HAASS: I said with the appropriate 22 documentation there would be closed portions as well 23 because there are certain things that, you know, that 24 are technically sensitive as well.

25 MS. GAVRILAS: Sure.

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150 1 MS. HAASS: And so any time we have a 2 topic, assume that there's going to be some, there's 3 most likely going to be something business sensitive 4 in there if it has anything to do with some details of 5 the facility.

6 MR. TIKTINSKY: You don't want to forget, 7 Dave Tiktinsky, the security related information 8 aspects of public meetings with technical discussions 9 which is different because that's a different part of 10 the regulations.

11 MS. GAVRILAS: Definitely.

12 MR. TIKTINSKY: So that's always something 13 we want to make sure that, you know, why we close 14 meetings related to discussions of that and 15 information that's the integrated safety analysis or 16 things that are preferably security related.

17 MR. BALAZIK: Anybody have anything else?

18 MS. GAVRILAS: Open it to the public I 19 would say.

20 MR. BALAZIK: All right, we can open up to 21 the public. Actually, I do have one more item.

22 Karen, you mentioned resources. Is there the 23 potential for any impact in the future for Northwest 24 resources for the review of this application, or even 25 future applications? There would be no change or any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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151 1 fluctuations that could potentially happen?

2 MS. HAASS: Well, there's no change in our 3 primary subcontractors, no.

4 MR. BALAZIK: Okay.

5 MS. HAASS: And they have the people to 6 support this. But, you know, you still have to 7 schedule it.

8 MR. BALAZIK: Yes, no. I understand, I 9 understand.

10 MS. HAASS: So yes, but that is not going 11 to change.

12 MR. LYNCH: I guess maybe just as a 13 closing question, do you feel like your expectations 14 were met today? Did we accomplish what you wanted to 15 accomplish at this meeting, or at least start moving 16 in the right direction?

17 MR. FOWLER: So we had two objectives as 18 we introduced this meeting from a Northwest Medical 19 Isotopes perspective. The first was gaining alignment 20 around or understanding in common of the licensing 21 application process.

22 And that one we've I think beaten to death 23 and are in violent agreement now with an understanding 24 from both NRC and from Northwest Medical Isotopes of 25 the options. And the follow up next step on that is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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152 1 to telegraph to the NRC our intentions. And so I 2 think from a first objective standpoint, we can 3 declare success on that one.

4 The second, and frankly more important one 5 to the nation and to public health and to public 6 safety is the speed with which we can accomplish a 7 successful review within the guidelines and 8 regulations.

9 I think this is, we did not have an 10 expectation that that would be solved in this meeting 11 today. Our expectation was that we would have a plan 12 to get to a plan.

13 What we accomplished in my view today is 14 I've received more granularity in the schedule 15 elements from the NRC and the assumptions behind the 16 schedules, how many iterations of RAIs, how many 17 iterations for the RCS and so forth.

18 So I think we now have a framework with 19 which we can succeed in a productive conversation on 20 translating the list, Steve, that you've so well-21 articulated and added to and convert that into an 22 operating plan.

23 And ultimately, what it comes down to to 24 a company like ours is predictability. Sufficient 25 granularity in schedules so we know what's next, how NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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153 1 do we assess that each one of those milestones whether 2 it's on track or off track, and our ability to predict 3 those next steps, manage accountability, manage 4 schedule, manage budgets.

5 The risk to any business, the biggest risk 6 to any business is uncertainty. And we've been in an 7 uncertain environment. And this meeting succeeded in 8 helping to remove some of the uncertainty in terms of 9 establishing a framework where we can now discuss the 10 schedule.

11 And a number of the elements are going to 12 obviously fall right back on us. We have better 13 expectations of what the standard is by which we need 14 to meet. But I think we also can establish a program 15 management plan so we collectively understand when a 16 milestone's been achieved and what the next milestone 17 that we all need to focus on.

18 MR. BALAZIK: And if there are no more, 19 this is Mike Balazik, again. If there are no more 20 questions in the room, first of all I guess I would 21 like to ask if there's any NRC staff on the phone that 22 has any questions. And then we'll open it up to the 23 public.

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154 1 from the NRC staff, so now I would like to open up the 2 phone lines to the public for public comment. Just a 3 couple of items.

4 Please, speak one at a time and identify 5 yourself in speaking. And also if you're 6 uncomfortable asking a question on the phone, you can 7 submit your question to me via email at mfb@nrc.gov.

8 Are there any public comments?

9 (No audible response) 10 MR. ADAMS: Can someone verify that the 11 phones are still open and working?

12 PARTICIPANT: Yes, the phones are open.

13 MR. ADAMS: All right, we just want to 14 make sure silence wasn't something unplugged 15 somewhere.

16 MR. LYNCH: Thanks, Jenny.

17 PARTICIPANT: We're here, thank you.

18 MR. BALAZIK: All right. So I think we 19 are, are we expecting Bill and others to join us 20 later?

21 MS. GAVRILAS: Yes. I think we'll adjourn 22 until 2:30 when we have an opportunity to interact 23 with two office directors. I think at least one 24 office director, perhaps two. And certainly my boss, 25 Lawrence Kokajko is going to join us.

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155 1 I don't know if Craig who is the acting 2 director in Shana's organization is also going to join 3 us. So you'll have an opportunity to reiterate, we'll 4 reiterate our action items and you'll have an 5 opportunity to interact with them.

6 MS. HAASS: And which office directors, 7 potentially?

8 MS. HELTON: Bill Dean.

9 MS. GAVRILAS: Bill Dean, our director is 10 coming for sure.

11 MS. HAASS: Okay.

12 MS. GAVRILAS: And his deputy might come 13 as well.

14 MR. ADAMS: So we're going to go mute on 15 the phones until 2:30 and then we'll be back on.

16 (Whereupon, the above-entitled matter went 17 off the record at 1:54 p.m. and resumed at 2:33 p.m.)

18 MR. BALAZIK: Mike Balazik, we're resuming 19 the public meeting. Right now we're toward the end of 20 the meeting. And we just want to real quickly go 21 through some closing remarks. Oh, I'm sorry.

22 Bill Dean, Office Director of NRR is 23 joining us, and Michele Evans has also joined us, and 24 Lawrence Kokajko has also joined is. He's the 25 Director of DPR, for our members on the phone. All NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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156 1 right.

2 (Off microphone comments) 3 MR. BALAZIK: Okay, can we just go through 4 everybody, identify themself that's new to the 5 meeting?

6 (Simultaneous speaking) 7 MS. EVANS: Sure. Michele Evans, Deputy 8 Director of NRR.

9 MR. KOKAJKO: Lawrence Kokajko, Division 10 Director, Division of Policy and Rulemaking.

11 MS. MARSHALL: Jane Marshall, Deputy 12 Director, Division of License Renewal, NRR.

13 MR. ERLANGER: Craig Erlanger, Acting 14 Director for the Division of Fuel Cycle Safety 15 Safeguards and Environmental Review.

16 (Off microphone comments) 17 MR. BALAZIK: Okay. You want to start?

18 MS. GAVRILAS: Yes, so we had what I would 19 qualify as a productive meeting this morning. And I'm 20 going to ask the Northwest Medical Isotopes to bring 21 their own clarification.

22 Mike and Steve prepared a few summary 23 points of the meeting that I'll ask them to go 24 through, a couple of action items. And then I know 25 that Bill would like to engage you in some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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157 1 discussions. And with that, I'm going to ask Mike to 2 summarize.

3 MR. BALAZIK: You going to go through the 4 points, Steve? You have the points?

5 MR. LYNCH: Whatever you would like.

6 MR. BALAZIK: Yes.

7 MR. LYNCH: I can go through it.

8 MS. GAVRILAS: One of you two needs to do 9 the summary of this morning, please, and the action 10 items. Thank you very much.

11 MR. LYNCH: All right. So I guess for 12 everyone's benefit that's in here that was not here in 13 the morning, we had two main objectives that we had 14 set out to accomplish as identified by Northwest, and 15 those were to talk about the licensing approach for 16 the facility. And then the second item was to talk 17 about mechanisms to expedite the review of Northwest's 18 construction permit application.

19 For the first point, we reached agreement 20 and a shared understanding that there is additional 21 technical information that Northwest will need to 22 provide to meet the Part 70 requirements in 10 CFR.

23 Whether that's submitted as part of their 24 operating license or as a separate application is up 25 to them, but we are in agreement that regardless of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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158 1 how the information is packaged, we understand on both 2 sides what technical information needs to be provided.

3 Is that correct?

4 And then the second point for mechanisms 5 to expedite the review, we went over a number of items 6 that we can do on both sides to make sure that we 7 review their construction permit application as 8 expeditiously as possible.

9 One of the items we discussed were 10 approaches to request for additional information to 11 limit both the total number of RAIs that we asked and 12 the number of rounds that we go through.

13 Ways that we can address that are ensuring 14 that the NRC is clear in the questions that we ask and 15 making sure that we have phone calls with Northwest 16 when those RAIs are issued to make sure they 17 understand the question that we are asking.

18 And also when they are getting prepared to 19 submit their responses, to have additional calls.

20 That may take the form of a public meeting if we need 21 to discuss technical details, or it could be shorter 22 clarification calls to make sure that they're on the 23 right track.

24 Again, the goal of that is to make sure 25 that we have a shared understanding of the NRC's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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159 1 expectations and what Northwest's understanding of our 2 expectations is. We also emphasize that quality and 3 completion of those RAIs is important as well.

4 This fed into a larger discussion of 5 appropriate methods of communication during the review 6 process. We have already established weekly calls 7 following the docketing of the application that Mike 8 and others as needed sit on with Carolyn once a week 9 to discuss the status of the review and then the other 10 administrative details as necessary. And that's 11 consistent with our practices for other reviews 12 throughout the agency.

13 MR. DEAN: So how long has that been going 14 on? For how long?

15 MR. LYNCH: Since January 12th.

16 MR. DEAN: Okay, all right.

17 MR. LYNCH: So right after we concepted 18 the review and everyone got back from the holidays.

19 MR. DEAN: Okay.

20 MR. LYNCH: We discussed the importance of 21 staying up to date on schedule, both from the NRC's 22 perspective as we're doing our review to make sure we 23 communicate how we're progressing towards milestones, 24 and also to get updates from Northwest on 25 anticipations of when, you know, if they have any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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160 1 delays on the current application, responses through 2 RAIs, and just updates of when they anticipate 3 submitting future applications such as their operating 4 license application.

5 We discussed, as far as the information at 6 Northwest provides what's the threshold of what's 7 acceptable to the NRC, we went there already following 8 our formatting content that I had provided in NUREG 9 1537 and the ISG augmenting NUREG 1537.

10 And as far as the threshold that we set 11 for the information that we're doing our review, we 12 told them that when we do our review we use our 13 standard review plan that is publically available, and 14 that is the threshold we set for the information that 15 we are looking for in their application.

16 And to maximize the efficiency of our 17 review, the clearer it is to us that they have 18 addressed the acceptance criteria in the standard 19 review plan, the easier it is for the NRC to move 20 forward quickly.

21 MR. DEAN: Both for the Part 50 and the 22 Part 70 aspects?

23 MR. LYNCH: Yes, yes. We discussed the 24 guidance for both aspects that they can use.

25 MR. DEAN: Okay.

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161 1 MR. LYNCH: We also talked about the 2 importance of reducing administrative time for 3 processing on the NRC side and also preparation of 4 documents on Northwest's side. The goal is through 5 our talks to make sure that there isn't significant 6 debt time where either side is sitting, not doing 7 anything and just waiting.

8 And this feeds into general program and 9 project management on both sides and making sure that 10 we are identifying clear goals towards working towards 11 the identified milestones that we have in the project.

12 And the last thing that we went over, or 13 I shouldn't say last thing, I could think of two more 14 things. Looking at past precedents, we have examples 15 of reviews we have done in the past, most recently 16 with SHINE, there are transcripts available from ACRS 17 meetings that they can look through as we go through 18 ACRS to help improve their preparation for those 19 meetings.

20 Also, they can get a sense from looking at 21 these applications for what the NRC has found 22 acceptable in the past and types of RAIs we've asked 23 in the past and what types of responses we're looking 24 for and similarity of reviews.

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162 1 license application, one way we can get ready for that 2 is we explore the possibility of having pre-3 application meetings to discuss the technical problems 4 or issues that may come up that we need to explore 5 before the application is submitted that there may be 6 questions on.

7 And also with the current construction 8 permit application, we talked about efficiencies that 9 can be gained from maintaining that document up to 10 date as they respond to RAIs and information in their 11 current PSAR needs to be updated, that they can 12 provide updates to that.

13 At times it will work out with Mike, it 14 will make it easier for our reviewers to have a single 15 document to look at that has all of the updated and 16 completed information, and also as we go forward to 17 the ACRS and with the mandatory hearing.

18 We also discussed earlier today the status 19 of our review and our plans going forward. So with 20 all of that, I think with that I think with those 21 topics, that addressed the second main point of 22 talking about ways that we could expedite the review.

23 I think that covers it for that second point.

24 MR. FOWLER: You did a good job, thank 25 you.

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163 1 MR. LYNCH: And then between 1:30 and 2:00 2 we came up with a list of action items to take away to 3 come back to in the future. The first of these was 4 setting up a, exploring the possibility of setting up 5 standing public meetings.

6 And this, Mike and Northwest will work 7 together on this to see if it's needed. But the idea 8 behind this is to cut down on some of that 9 administrative time.

10 If we see the need to discuss significant 11 technical information, most likely related to RAIs on 12 a regular basis, instead of noticing public meetings 13 every time we need to have one, we set up a frequency 14 maybe once a month, once every other month, something 15 that's agreed upon between both parties. That was 16 identified as a topic worth exploring in the future to 17 see if it could help in the review.

18 The next action item we had was in a 19 future meeting discuss when the final design for 20 Northwest will be provided to the NRC. This includes, 21 you know, the final design could be submitted as part 22 of the operating license application, or it could be 23 submitted while we are still reviewing the 24 construction permit.

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164 1 help us in our preparations. And then on our side of 2 that, we can discuss with them in the future the 3 impact of their decision to go forward one way or 4 another, without recommending a preference.

5 The third item that I had here was the NRC 6 could benefit also from understanding any additional 7 licensing actions that Northwest may request in the 8 future.

9 This could be related to transportation of 10 materials, any exemptions that they foresee needing 11 for their current licensing requests or future 12 licensing requests. Also, license amendments that 13 existing research reactors might need in order to 14 support the radiations of their manufacture targets.

15 Fourth item that we had as a take-away was 16 making sure that we have clear expectations on both 17 sides. This has to do with, mostly with requests for 18 additional information.

19 Northwest would like to be able to review 20 drafts of the RAIs for potential proprietary 21 information before they're issued. And also to the 22 extent practicable, we would like notifications of 23 when the RAIs are getting close to being issued so 24 that they can make sure that their resources are ready 25 to receive any begin working on responses to them.

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165 1 Also, Northwest offered that for future 2 public meetings, that we have it out in Missouri, that 3 the local government there is willing to work with us 4 in getting that set up in the future as well.

5 And I think the last thing, the last 6 action item I had on here was on both sides, and it's 7 kind of relates to everything else we've just been 8 talking about is just having clear communications on 9 both sides of schedule, NRC making sure that we 10 identify the milestones that we're working towards and 11 our progress towards that and Northwest, again letting 12 us know their schedule and any impacts they may have.

13 MR. DEAN: Okay, is that it?

14 MR. LYNCH: Yes.

15 MR. DEAN: Okay. Good. Sounds like you 16 guys had a productive meeting. So appreciate you guys 17 coming here from Oregon? Both of you from Oregon?

18 MS. HAASS: The northwest.

19 MR. DEAN: Northwest? Okay. Go Ducks.

20 No?

21 MR. FOWLER: Well, we have Ducks and 22 Beavers.

23 MR. DEAN: Okay, all right. Depends what 24 part.

25 MS. HAASS: I'm a Husky.

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166 1 MR. DEAN: Okay, depends on what part of 2 the state that you're from. Well, so I appreciate you 3 guys coming in. And it sounds like it was very 4 productive and useful meeting.

5 I know that you all were here not too long 6 ago and had expressed some concerns with some of our 7 commissioners and some of our senior management about 8 the process and not having a good understanding of the 9 process.

10 And so it sounds like, and I certainly 11 would be interested in your all's perspective that 12 today's meeting helped move us forward in terms of 13 establishing better communication and better 14 understanding of what you can expect from us, but also 15 things that we hope that we can engender from your 16 side of it because I view, personally I view this 17 process, and it's a big deal right, moly-99 is a big 18 deal for this country.

19 And so you guys are pursuing something 20 that is important to public health and safety which is 21 obviously the ultimate mission or objective of the 22 NRC, that we do it in a collaborative way and not in 23 any sort of adversarial way.

24 I know there's always just sort of dynamic 25 in terms of a licensee or an applicant and the NRC and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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167 1 we ask a bunch of questions, you got to give us a 2 bunch of answers.

3 But in reality, I think we're all striving 4 to get to the same point which is can we get licensed 5 for construction and utilization a facility that can 6 be useful in providing moly-99.

7 So in that regard, I think what we have is 8 a very common end point. So I guess I would be 9 interested in your all's perspective in terms of how 10 you thought today's discussion went, were we able to 11 address perhaps some of the concerns you've had in the 12 past.

13 And if there's still some open questions, 14 you know, Steve went through a list of action items, 15 but are there still some things that you all have in 16 your mind that are kind of open or areas that we ought 17 to consider.

18 Like, one thing I didn't hear in your 19 discussion was the benefit of, you know, sometimes 20 when we get an RAI process there's this kind of 21 throwing stuff over the transom and then you all 22 develop and throw it back over the transom.

23 And sometimes we can make better progress 24 if we do things like, well we call them audits, right, 25 but we actually either send people to wherever the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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168 1 information is and have face to face meetings as 2 opposed to going into a sort of a writing campaign.

3 Is that something you guys talked about was the audit 4 process?

5 MR. LYNCH: We did not talk about that 6 today. But we have had an audit on the environmental 7 side as they were preparing information.

8 MR. DEAN: Okay.

9 MR. LYNCH: So we have gone through that.

10 MS. HAASS: And we've had the discussions 11 in the past and we know that it's one of the tools we 12 can use to make things more efficient.

13 MR. DEAN: Okay. Okay, good. Okay, and 14 then the other one was I didn't hear anything about 15 would it be beneficial for example to set up an 16 electronic reading room where you guys have materials 17 that you developed that are accessible to our staff 18 through some sort of portal or whatever so there's 19 more ready actions instead of you guys having to mail 20 them.

21 MS. HAASS: Well, and we are setting that 22 up. There's always technical difficulties because you 23 guys have some requirements and you know what they 24 are, you know, about the encryption and the passwords 25 and this, that, and the other. And so those things NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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169 1 are getting set up.

2 MR. DEAN: Okay. I think we've had some 3 success where the licensee sort of maintains that and 4 then we just get a password for access and it helps 5 maybe avoid some of those, you know, red tape things 6 that we tend to have as a bureaucracy.

7 But anyway, so we certainly, that would be 8 something that could hopefully improve or increase 9 efficiency.

10 MS. HAASS: Well, and another thing that 11 could help efficiencies is I know we talked about it 12 a bit offline just standing here. But, you know, some 13 granularity on how, what RAIs are going to be coming 14 because you're not going to throw all of them over at 15 once.

16 You may be doing them based on subject 17 matter areas and, you know, getting a better 18 granularity in a schedule like that because that helps 19 both your resources and ours and us to be more 20 efficient in responding as well.

21 MR. DEAN: So I was pleased to hear that 22 you guys have set up weekly calls. So hopefully 23 you're finding those beneficial. I know that we do in 24 terms of being able to ferret out those sort of 25 things.

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170 1 And I don't know whether, have you guys 2 kind of developed sort of a standing agenda, or has it 3 kind of been sort of ad hoc? I would assume that 4 there's things that week to week that you're going to 5 want to talk about.

6 MS. HAASS: Yes, there's definitely a 7 standing agenda. But then, you know, you've got 8 things come on and off that agenda as well.

9 MR. BALAZIK: And this is Mike Balazik.

10 And sometimes we'll share stuff earlier in the week 11 that is to be a great topic to have on that weekly 12 call so that we can take one level deeper into it if 13 it's just Kevin and I talking. Sometimes we'll move 14 stuff on a weekly call.

15 MR. DEAN: And also to make sure we get 16 the right people there.

17 MR. BALAZIK: Correct.

18 MR. DEAN: Okay, all right. So that's 19 good. I think that's a great initiative to do that.

20 So at least what I'm hearing was that it was a 21 constructive, worthwhile meeting, is that --

22 MR. FOWLER: I do believe it was a very 23 productive meeting. And for those of you who attended 24 our meeting about a month ago in the Executive 25 Director's office, we understand that the NRC has a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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171 1 mission for public health and takes the production 2 capability this country for moly-99 very seriously.

3 We understand that, appreciate that, 4 respect that. I hope that you all also understand 5 that we take our mission of providing that secure, 6 reliable supply of moly-99 in the United States 7 extremely seriously. That was part of the intent with 8 the Executive Director's office when we were there.

9 We also wanted to communicate that while 10 we all know that this is a public health potential 11 issue, sometimes hearing directly from the feet on the 12 street, the constituents and our supporters and 13 investors are public healthcare institutions serving 14 tens of millions of people across the United States.

15 And so to hear directly from the CEOs of 16 those public health services organizations I think is 17 important to remind us of just how real the mission 18 that we share collaboratively really is. It's 19 extremely important.

20 This meeting stemmed as a follow up to a 21 couple of outstanding items from the initial meeting, 22 the first being clarification on our licensing 23 application submission process. And that one, declare 24 victory.

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172 1 all, I think, are in agreement that we understand 2 where to go from here. We will need to telegraph our 3 approach so that the NRC can anticipate. But we're 4 all on common understanding of that first objective.

5 So declare success on that one.

6 The much broader one is how do we meet the 7 needs of this country in a timely fashion. And what 8 we achieved today was establishment of a very strong 9 framework that we now understand better how the 10 schedule of review is constructed and built within the 11 NRC.

12 That helps tremendously because we can 13 look at the assumptions, we can compare the 14 assumptions, and we can begin to manage this as a 15 project. It's likely, in fact it's assured, that 16 we'll need a number of follow up conversations to 17 translate that framework into a plan that can be 18 project managed, and we've left with a joint objective 19 to do exactly that.

20 And Steve did a great job of summarizing 21 some of those actions. And so we can't yet close with 22 full success the second objective on accelerate the 23 schedule to degree possible.

24 I think we have a pathway to continue a 25 process to get to a mutually agreed schedule, one that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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173 1 we can both bring back to our supporters and manage 2 against with expectations, identify milestones, 3 identify where we've deviated from milestones, and 4 take remedial actions as appropriate.

5 And that, to me, is a successful day spent 6 here in the DC area.

7 MR. DEAN: Well good, I'm pleased to hear 8 that, Nick, in terms of your perspective on how the 9 meeting went because certainly this was one that I 10 felt was very important, you know, the fact that 11 Michele and I and Lawrence wanted to make sure that we 12 touched base with you all before you left to make sure 13 that the meeting met your objective was very important 14 to us.

15 And so that gives me great confidence that 16 we did have a constructive and productive dialogue.

17 But we need to sustain that.

18 MR. FOWLER: Exactly right.

19 MR. DEAN: And I like some of the things 20 you guys have talked about in terms of potential 21 action items. I was interested a little bit more in 22 exploring the topic that Steve raised that when we 23 have meetings in Missouri and the engagement of the 24 local government.

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174 1 we trying to achieve with that. That's a good thing, 2 but I mean --

3 MR. FOWLER: That was in specific 4 reference to any ongoing environmental public meeting 5 needs where we've had one meeting in Columbia already.

6 If there were needs for others, the City of Columbia 7 and the County of Boone County in Missouri have 8 offered any and all assistance to the NRC if any is 9 requested.

10 MR. DEAN: Okay.

11 MR. FOWLER: They stand ready to help.

12 MR. DEAN: Okay.

13 MR. LYNCH: And this is consistent with 14 previous reviews, even for the SHINE review we've gone 15 out for the environmental meetings generally, send an 16 email to the city manager and county executives, let 17 them know we're coming, offer any government-18 government interaction they would like to better 19 understand our process and work our way forward.

20 MR. DEAN: Okay.

21 MR. LYNCH: So that's all consistent.

22 MR. DEAN: Okay. Good, okay. Good.

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175 1 available.

2 MR. DEAN: That's great.

3 MS. HAASS: And so, and they want to be 4 involved.

5 MR. DEAN: Super. Okay, that's wonderful.

6 Okay, good. Okay. Anything for me that you would 7 like to convey beyond what you already have?

8 MR. FOWLER: Well I think that again, 9 we've had a successful meeting. I think in other 10 strategic partnerships that are collaborative in 11 business that I run, we have not only program 12 management at the level of checking all the boxes on 13 the program plan, we have a refreshment at this level 14 to ensure that both parties are in fact comfortable 15 with progress and resource assignments and strategic 16 alignment as we move forward.

17 Certainly it doesn't need to be a monthly 18 meeting at this level, but probably on a quarterly or 19 semi-annual basis it would make sense for us to touch 20 base at this level to ensure that we're both meeting 21 each other's expectations of moving forward.

22 MR. DEAN: Okay. And you're comfortable 23 with the 12 to 15 to 1 ratio of members of the NRC?

24 Is that okay? You're comfortable with that ratio?

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176 1 we'll reverse the ratio.

2 MR. DEAN: Good, good. Well, anything 3 else that you would like to achieve today?

4 MS. GAVRILAS: No. I think we met their 5 objectives and we have a good meeting.

6 MR. DEAN: Okay, good. Good. All right, 7 so who do I point to in terms of is it Mike is the 8 sort of individual that I want to point to as 9 somebody, for SHINE I went to Steve a lot. So is 10 Mike?

11 MS. GAVRILAS: So that was one of the 12 issues we discussed that even though there are 13 multiple organizations involved in the review, there 14 will be one voice for the NRC and that voice is Mike.

15 MR. DEAN: Okay, good. Okay, good.

16 Super. Okay, anything else? Excellent. Okay.

17 MR. FOWLER: Finished the agenda on time.

18 MR. DEAN: Safe travels. Safe travels 19 back.

20 MR. BALAZIK: This is Mike Balazik. I 21 just want to thank everybody for attending the meeting 22 today. And we're going to close the bridge line.

23 Thank you.

24 (Whereupon, the meeting in the above-25 entitled matter was concluded at 2:58 p.m.)

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