ML16083A106

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

ML16083A106
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Site:	Northwest Medical Isotopes
Issue date:	02/18/2016
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NRC-2177
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Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Meeting with Northwest Medical Isotopes Doc ket Number:Location:Rockville, Maryland Date:Thursday, February 18, 2016Work 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 UNITED STATES OF AMERICA 1 NUCLEAR REGULATORY COMMISSION 2+ + + + +3 PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC 4+ + + + +5 THURSDAY, 6 FEBRUARY 18, 2016 7+ + + + +8 ROCKVILLE, MARYLAND 9+ + + + +10 The Public Meeting commenced in Room O-11 16B4, One White Flint North, 11555 Rockville Pike, at 12 8:30 a.m., Mike Balazik, Project Manager, presiding.

13 14 NRC STAFF PRESENT:

15 LAWRENCE KOKAJKO, Director, Division of Policy and 16 Rulemaking, Office of Nuclear Reactor 17 Regulation 18 WILLIAM DEAN, Regional Administrator, Region I 19 CRAIG ERLANGER, Acting Director, Division of Fuel 20 Cycle Safety, Safeguards, & Environmental 21 Review, Office of Nuclear Material Safety and 22 Safeguards 23 MICHELE EVANS, Deputy Director, Office of Nuclear 24 Reactor Regulation 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 2 JANE MARSHALL, Deputy Director, Division of License 1 Renewal, Office of Nuclear Reactor Regulation 2 MICHAEL BALAZIK, Project Manager, Division of Policy 3 and Rulemaking, Office of Nuclear Reactor 4 Regulation 5 ALEXANDER ADAMS, Chief, Research and Test Reactors 6 Licensing, Office of Nuclear Reactor 7 Regulation 8 MIRELA GAVRILAS, Deputy Director, Division of Policy 9 and Rulemaking, Office of Nuclear Reactor 10 Regulation 11 SHANA HELTON, Acting Deputy Division Director, 12 Division of Fuel Cycle Safety, Safeguards &

13 Environmental Review, Office of Nuclear 14 Material Safety and Safeguards 15 ROBERT JOHNSON, Chief, Fuel Manufacturing Branch, 16 Office of Nuclear Material Safety and 17 Safeguards 18 STEVE LYNCH, Project Manager, Research and Test 19 Reactors Licensing Branch, Office of Nuclear 20 Reactor Regulation 21 NANCY MARTINEZ, Environmental Project Manager, 22 Office of Nuclear Reactor Regulation 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 3 DAVE TIKTINSKY, Project Manager, Fuel Manufacturing 1 Branch, Office of Nuclear Material Safety and 2 Safeguards 3 4 ALSO PRESENT:

5 NICHOLAS FOWLER, Chief Executive Officer, NWMI 6 CAROLYN HAASS, Chief Operating Officer, NWMI 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 4 T-A-B-L-E O-F C-O-N-T-E-N-T-S 1 Page 2 Opening Remarks by NRC Staff 3 Michael Balazik..............6 4 Mirela Gavrilas..............13 5 Shana Helton...............14 6 Opening Remarks by Northwest Medical Isotopes 7 Nicholas Fowler..............15 8 NRC Licensing Processes 9 10 CFR Part 50, General 10 Steve Lynch................20 11 10 CFR Part 51, Environmental 12 Nancy Martinez..............36 13 10 CFR Part 50, Construction & Operating License 14 Steve Lynch................42 15 NRC Licensing Process, Part 70 16 Dave Tiktinsky..............90 17 Licensing Review Request (NWMI licensing request and 18 NRC understanding of request - NRC/NWMI) 19 Al Adams................113 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 5 Communications (NRC/NWMI) 1 Michael Balazik.............126 2 Steve Lynch...............130 3 Al Adams................134 4 Dave Tiktinsky.............135 5 NWMI Topics for Discussion..........141 6 Closing Remarks/Summary............155 7 Adjourned...................176 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 6 P-R-O-C-E-E-D-I-N-G-S 1 (8:33 a.m.)

2MR. BALAZIK: All right, good morning.

3I'd like welcome everyone in attendance today. My 4name is Mike Balazik. I'm a project manager in the 5 Division of Policy and Rulemaking at the NRC.

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

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

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

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

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

24 There's a sign-in sheet that may be moving around the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 7 room right now. I ask everyone sign in. Yes, thank 1 you.2 If you wish to provide any comments on the 3 meeting, I can provide you a meeting feedback form.

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

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

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

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

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

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

24 Before we begin, a couple of items I'd 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 8like to mention. First of all, please limit 1interruptions. Silence your cell phone and please 2 keep side conversations to a minimum.

3I ask you speak one at a time. And 4individuals on the phone, please mute your phone 5 unless you're going to provide any comment.

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

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

10 Next I'd like to remind you that you're 11within a NRC controlled space. Should there be an 12 emergency all occupants should begin to calmly 13evacuate using the nearest stairwell to exit the 14 building.15 All visitors will be escorted by the NRC 16staff. Disables persons, who due to health reasons 17 feel they cannot safety walk down the stairs to 18evacuate, may use the elevators. Exit through the 19 nearest door and then go to the pause area in front of 20 One White Flint and report their presence with the 21 guard.22 So you experience, observe anyone with a 23 life threatening medical complaint while evacuating, 24call 911 and report your location and nature of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 9 emergency.

1Also, if you need to use the restroom, 2 you'll need to be escorted.

3All right. So let's now run though 4introductions. I'd ask everyone to speak loudly so 5people on the phone can here you. And let's start 6 around the table.

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

10MS. MARTINEZ: Good morning. I'm Nancy 11 Martinez, NRC Environmental Project Manager.

12MS. GAVRILAS: Mirela Gavrilas, Deputy 13 Director, Division of Policy and Rulemaking in NRR at 14 the NRC.15MR. LYNCH: This is Steve Lynch. I'm a 16 Project Manager with Research and Test Reactors.

17 And real quick, before we go on with the 18 introductions, if you are participating on the phone, 19could you please put your phone on mute? We're 20getting a lot of feedback in the room here. Thank 21 you.22MR. ADAMS: Al Adams, Chief of Research 23 and Test Reactor Licensing, NRC.

24MR. TIKTINSKY: Dave Tiktinsky, Project 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 10 Manager of the Field Manufacturing Branch in Office of 1 Nuclear Material Safety and Safeguards.

2MR. JOHNSON: Good morning. Robert 3 Johnson, Fuel Manufacturing Branch Chief, NMSS.

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

6MR. FOWLER: Nick Fowler, the Chief 7 Executive Officer of Northwest Medical Isotopes.

8MS. HAASS: Carolyn Haass, Chief Operating 9 Office, Northwest Medical Isotopes.

10MS. KEIM: Andrea Keim, Vendor Inspection 11 and Quality Assurance, NRR.

12MR. MATULA: Tom Matula, NMSS, Project 13 Manager.14MR. MORRISSEY: Kevin Morrissey, Fuel 15 Cycle Review.

16MS. ADAMS: Mary Adams, Fuel Cycle Safety 17 and Environmental Review.

18MS. LONDON: Lisa London, Office of 19 General Counsel.

20MS. BIELECKI: Jessica Bielecki, Office of 21 General Counsel.

22MR. LINDELL: Joseph Lindell, Office of 23 General Counsel.

24MS. KANATAS: Catherine Kanatas, Office of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 11 General Counsel.

1MS. YOUNG: Mitzi Young, Office of the 2 General Counsel.

3MS. TRAN: Linh Tran, Research and Test 4 Reactor Licensing Branch, NRC.

5MR. ALLEN: Eben Allen, Research and Test 6 Reactor, Project Manager.

7MR. BALAZIK: This is Mike Balazik, please 8mute your phones. Somebody's got an open line and 9 they're speaking and we're hearing you in the room.

10 MR. LYNCH: Star 6.

11MR. DANNA: Jim Danna, NRR, Division of 12 License Renewal.

13MR. MILLER: Chris Miller, Office of 14 Nuclear Reactor Regulation. And I'm the Director of 15 the Division of License Group.

16MR. ISAAC: Patrick Isaac, Research 17 Reactor Oversight Branch.

18MR. BALAZIK: All right, this is Mike 19Balazik again. Let's go to the phone line. I ask 20 individuals to identify themselves.

21MR. RODRIGUEZ: Michael Rodriguez, NRC, 22 NSIR EP.23 MR. FLAGG: Michael Flagg, University of 24 Missouri Research Reactor.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 12 MS. MCCULLOUGH: Kara McCullough, NSIR, 1 NRLB.2 MR. BERICK: Dave Berick with Senator Ron 3 W.4 MS. RIVERA: Alison Rivera, NSIR EP.

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

7 MS. WEIL: Jenny Weil, Congressional 8 Affairs.9 MS. FRAZIER: Andy Frazier, Region III 10 Office.11 MS. MOSER: Michelle Moser, Environmental 12 Energy Staff.

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

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

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

19 MR. FOLK: Kevin Folk, NRC Environmental 20 Staff.21 MR. WEBER: Carl Weber, NRC, Office of New 22 Reactors.23 MR. BALAZIK: Is there anybody else on the 24 phone that wishes to identify themselves? Okay, I'm 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 13 hearing none.

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

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

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

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

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

22 So our main objective today is basically 23 to discuss the topics that we agreed with Northwest 24Medical, should be discussed today. And we want to 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 14have open dialogue. So please ask questions at any 1 time.2 Again, we have the technical and the 3 regulatory experts in the room to address your 4questions. So we want to make sure that at the end of 5 the meeting, we're aligned in terms of our 6 understanding of where we are in terms of the review 7 of the construction permit that's in front of us now, 8 as well we the preview of the operating license that 9 is still to come.

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

13MS. HELTON: Thanks, Mirela. I agree with 14Mirela's points. I can't emphasize enough the need to 15 obtain clarity on both sides, so that we can have an 16 efficient, effective licensing path forward.

17 And to that end, I just want to say, that 18 while multiple offices are involved with this review, 19we do act as one NRC. You will hear from us with one 20 voice.21 Mike Balazik will be your primary point of 22 contact. So you don't have to worry about trying to 23 correlate between different offices.

24 And just as we go through this, one point 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 15 that I wanted to emphasize is that for each 1 application that we receive as an Agency, not just in 2 this area of medical isotopes, we review each 3 application based on its merits.

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

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

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

16MR. BALAZIK: This is Mike Balazik. Thank 17you, Shana.

Now I'll turn it over to Northwest 18 Medical Isotopes for some opening remarks.

19MR. FOWLER: Well, and I would add my 20thanks to everyone that's assembled here. In that we 21all understand the importance of serving a reliable 22 and secure supply within the United States for moly-23 99.24 And we met with the executive director and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 16 his direct staff and a number of folks who are in this 1 room a month ago. And we believe, Northwest Medical 2 Isotopes believe, it was an excellent conversation.

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

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

9And we all recognize the need for this 10reliable supply of moly in the United States. But 11 sometimes hearing it from a healthcare services 12 provider that's responsible for millions of people, 13 who can provide that direct testimony of what it means 14when there are shortages, is important. And we 15 thought that important to provide that direct 16 perspective into the executive meeting a month ago.

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

23 We then had a fruitful discussion on two 24 questions that Northwest Medical Isotopes had 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 17specifically. And we hope that this meeting today 1 directly addresses those two questions as follow up to 2 that meeting.

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

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

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

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

23 And in the interest of everybody's time 24 assembled, I think the package is great from an 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 18educational standpoint. I think we understand largely 1 the background.

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

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

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

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

15MR. BALAZIK: Thank you, Nicholas, I 16 appreciate that.

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 19 What we're trying to understand is, not 1 just what your questions are, but why you asked those 2questions. Because we want to make sure that we're 3 answering, not just the words, but the intent of what 4 you're trying to find out.

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

10MR. BALAZIK: All right, this is Mike 11Balazik again. First of all, for transcription 12 purposes, please identify yourself prior to speaking.

13 And let's start the presentation.

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

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

23 Basically this is the meeting purpose.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 20 Just provide a general overview of the NRC, oops, I'm 1 sorry. It skipped one on me.

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

8 Okay?9 And next we'll go into the licensing.

10MR. LYNCH: Sure. This is Steve Lynch.

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

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

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

20 Is we've done something before, hopefully the next 21 time we do it we can apply the lessons learned from 22 before.23 So to get started with this introduction 24 here, these considerations are for both the applicant 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 21 and the NRC. We want to emphasis that where we pick 1 the licensing process from the regulations is driven 2 by the technology that's put in front of us.

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

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

10Are you going to be making targets, are 11 you going to be irradiating targets, will you be 12processing targets. How will you be irradiating your 13 targets. Will you be using a nuclear reactor. Will 14 an accelerator be involved.

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

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

23 And then one of the other considerations 24 we look at is, will you be using new or existing 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 22facilities. And as I understand with Northwest, it 1will be a mixture of both. Using existing research 2 reactors as well as constructing a new facility for 3 processing.

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

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

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

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

20Next slide. So we're going to spend today 21 highlighting some of the different processes that we 22use from that previous slide. Especially focusing on 23 Part 50, for the production facility, Part 70, for 24material. And then also Part 51 for the environmental 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 23 review process.

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

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

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

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

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

24 Another main component of the operating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 24 license application will be the Physical Security 1 Plan.2 Our commitment to doing these reviews, for 3 both the construction permit and the operating 4 license, is to finish these reviews within a year and 5 a half to two years from docketing the application.

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

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

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

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

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

24 That's Section 103.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 25 And as I'm sure you're aware, this is 1slightly different than most of the other non-power 2 facilities that we license under Part 50. Those are 3 generally research reactors that are non-commercial 4 facilities.

5 And the main difference that we see there 6 is that there will be a mandatory hearing on your 7 application. And there will be a review by the ACRS 8 as well.9 The other, some of the other things that 10 you're aware of under 50.30, you're to submit an 11environmental report, which you have done. And submit 12 a preliminary safety analysis report under 50.34, also 13 what you have done.

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

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

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

24 50.35, which I'll go into more detail on on the next 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 26 slide, as far as the findings that the commission 1 needs to make in order to issue a construction permit.

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

4Next slide. So as the NRC evaluates your 5 application, these are the primary four findings that 6 we are looking to make, based on the information that 7 you have provided.

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

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

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

16And that you are left to propose your own design 17 criteria per your facility in this case.

18 We also recognize that we are being 19provided a preliminary design. And as such, there may 20 be information that you have not provided at this 21 time.22 We're looking to make the conclusion that 23 the information you have chosen to provide at a later 24 date is acceptable, but we don't need it at this time 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 27 in order to establish a preliminary design.

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

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

13Next slide. So this slide, what I wanted 14 to emphasize is the difference between the 15 determinations that we're making at the construction 16 stage and at the operating license stage.

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

21 In contrast, when we issue an operating 22 license, this is when we say that, based on the final 23 design of the facility, that we believe it can be 24operated safety. So I just wanted to emphasize the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 28 difference in the emphasis that we place in those two 1 determinations.

2Next slide. So I'm hoping this slide 3 helps partially answer one of your questions that you 4 had about the l icensing process and how we look at 5your applications and how you can submit them. And 6 we'll go into some more detail on this when we get 7 specific with your application.

8But both the Atomic Energy Act and the 9 regulations allow for an applicant to combine 10 applications. And this is common.

11 There's, and mostly we'll see this with 12the operating license application. In order for 13 reactors to operate, they will also require a Part 70 14 license in order to possess and use material on their 15 site.16 And then following that up, the commission 17does combine those licenses. So you see, and Al will 18 show you an example of that later today.

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

24 So we are --

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 29MR. FOWLER: Can I ask a question at this 1 point?2 MR. LYNCH: Yes.

3MR. FOWLER: At the executive director 4meeting, Mirela, I believe you did a, at least you 5 helped me, and I'll use the, I could use inappropriate 6 terms in the regulatory environment because it's not 7 an environment that I deal with every day, but I 8 understood from your presentation, in that meeting, 9that we had the choice. That we could submit a 10 separate Part 70 license or we could submit, under the 11 Part 50 umbrella, the Part 70 requirements with the 12 important caveat that the Part 70 information, at that 13 point of submission, needed to be final because it was 14 a one-step process.

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

22MS. GAVRILAS: What I said at the meeting 23is still what our position is. And we'll walk you 24 through the slides.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 30This just helps explain the details. The 1 bottom line is, we look at your activities from a 2 safety perspective. And the security perspective.

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

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

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

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

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

23 If the activity was described on one piece of paper, 24you get credit for it. You don't need to describe it 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 31 again.1MS. HELTON: Mirela, I agree. I just want 2 to make sure that it's clear that the packaging is up 3to you. How you package it all together, multi 4 submissions, a single submission.

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

10 So it just has, however you do your 11 packaging, it has to be very clear that if you intend 12 for this information to satisfy Part 70, subpart (h), 13 or whatever you're going to do, that you have to very 14 explicitly.

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

21MS. GAVRILAS: And to add to what Shana is 22 saying, you can cross reference in all of your 23 document that you submitted.

24 MS. HELTON: Right.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 32 MS. GAVRILAS: And right away, that adds 1 to the case that I'm trying to make in this piece of 2 paper.3MR. FOWLER: So very simplistically, from 4 my standpoint, again, because I'm not schooled in the 5 art of regulatory review, is the final Part 70 6 information, we can include, either in our operating 7 license under Part 50 application or as a separate 8 Part 70 document, but we need to be clear about what 9 we're submitting under which format.

10 MS. HELTON: Right.

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

17MR. LYNCH: Yes. And I think what's most 18 important there is, we're looking to make our safety 19 determination based on technical information that you 20 provide.21 Whether it's Part 50 or Part 70, we still 22 have to say, we have technical requirements that we're 23trying to make to justify safety. So we're looking 24 for technical information.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 33 And when we have all that technical 1 information, we can figure out which box, you know, 2 will it be a full, will it be Part 50 with Part 70 as 3part of that or separately. But we will evaluate that 4 based on the request that you ask of us.

5MS. HAAS: We understand the safety 6aspect. I mean Nick is just trying to bring it up --

7 MR. FOWLER: Yes.

8MS. HAAS: --

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

11 So we just wanted to make sure that we understood it, 12and we do. So thank you for the input and we'll move 13 on.14MS. GAVRILAS: You know, we start every 15 public meeting with a disclaimer, which is, we're not 16 going to reach regulatory decisions here and there's 17 a reason for that.

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

21 So we have dialogue here. So right now, 22 what we have for review in front of us and what we can 23 be very specific on, at least the portions that we've 24reviewed, is the construction permit. The Part 50 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 34 construction permit.

1 Anything else is in pre-application space.

2 If that makes sense?

3 So if there is

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

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

10MR. LYNCH: Okay. Next slide. So what 11 we're going to transition to now is talking a little 12 bit more about the actual review process for the 13construction permit. And we'll get into timelines and 14 what our expectations are for the review that we have 15 ahead of us.

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

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

23 The results of each of these reviews will 24 feed into a number of things that will lead ultimately 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 35 to the commission's decision to either grant or deny 1 your request for a permit.

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

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

8 There's also a possibility that there 9 could be contentions filed as a result of this. And 10 we'll talk a little bit more about that in a few 11 slides, but that's another step that could be in this 12 process.13 The environmental review will also be, the 14 environmental impact statement that's being prepared, 15 will also be considered by the commission and its 16 decision to grant or deny the construction permit.

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

23MS. MARTINEZ: Thank you, Steve. As Steve 24 mentioned, I'm the environmental project manager for 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 36the application. And I'm going to discuss the 1 environmental review process.

2 The environmental review is going to be 3 performed in accordance with the National 4 Environmental Policy Act of 1969. Commonly known as 5 NEPA.6 NEPA requires fellow agencies to follow a 7 systematic approach in evaluating the potential 8 environmental impacts of the proposed action and to 9assess the alternatives to those actions. The NEPA 10 process involves public participation and disclosure.

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

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

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

21 If the application is accepted, the NRC 22staff conducts a NEPA document determination. And 23 that is to whether develop and prepare an 24 environmental assessment or an environmental impact 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 37 statement.

1 I will discuss in later slides, for the 2 Northwest application, the staff determined to prepare 3an environmental impact statement. Once the NEPA 4 determination is made, the environmental review 5 process is conducted in accordance with 10 CFR Part 6 51.7 Slide 18 please. This slide presents an 8 overview for NRC's environmental process.

9 Specifically for the environmental impact statement.

10 The environment review for an EIS begins 11with the scoping process. Which includes a public 12 meeting.13Scoping is a process by which the NRC 14 staff identifies a specific impact and significant 15 issues to be considered in preparation of the 16 environmental impact statement.

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

22 The draft EIS is issued for public 23comment. Once comments are received on the draft, the 24 NRC staff will consider those comments and issue its 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 38 final environmental impact statement.

1Slide 19 please. The environmental review 2 for the environmental impact statement will take 18 to 3 22 months. This slide provides a detailed breakdown 4 of the process and timeframes.

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

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

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

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

24 Information from the applicant's report, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 39 RAI responses, the scoping process, coordination with 1 other federal, state, tribal and local agencies, as 2 well as the staff's independent research, will be used 3 to draft the EIS.

4 When the draft EIS is published, it will 5 be made publically available for review and comment 6 for a 45 day period, in accordance with our 7regulations. The comment period will include a public 8 meeting.9 After the draft EIS comment period, the 10 staff will respond to comments provided on the draft 11EIS and update the EIS as necessary. And this can 12take approximately 120 to 150 days. And depends on 13 the number of comments and also the necessary EIS 14 updates. The final EIS is then issued.

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

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

23 The NRC staff conducted an acceptance 24 review of the Northwest environment report, Chapter 19 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 40 of the application, in accordance with 10 CFR Part 51, 1 which identifies the information that shall be 2 contained in the applicant's environmental report.

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

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

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

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

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

23Slide 23 please. The environmental review 24 will consider the impacts of construction, operation 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 41and decommissioning of the Northwest facility. We 1 will also consider the impacts of alternatives to the 2 proposed action, including alternative sites, 3 alternative technologies and the impacts of not 4 issuing a construction permit.

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

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

16Slide 24. The Northwest environmental 17scoping period ended January 4th, 2016. The staff is 18 currently developing the scoping summary report and 19 responding to comments.

20Two rounds of RAIs have been issued. The 21 first on November 2nd. Northwest responded to those 22RAIs on December 3rd. The staff reviewed the 23 responses and had some follow ups. And those RAIs 24 were issued on January 19.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 42 NRC anticipates that the draft EIS will be 1 issued on October 2016 and that the final EIS will be 2issued on May 2017. And this is based on the 3 timeframes in the slide that I have provided earlier.

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

5 And that concludes my presentation on 6 environmental review.

7MR. LYNCH: All right, next slide please.

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

9And I'm going to talk a little bit about the 10 construction permit safety review process.

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

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

23 While you're not required to submit 24 technical specifications at this time, we are looking 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 43 for the application to identify probable subjects of 1 technical specifications.

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

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

8Next slide please. So for the review that 9 we do, so the last slide talked about the regulatory 10requirements that need to be met. We had developed 11 guidance in order to evaluate whether those 12 requirements have been met.

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

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

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

21Other guidance that we used. There are 22 ANSI standards that are referenced in these documents 23 we used for our reviews as well.

24 Next slide please. So getting more into 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 44the process and timeline. After you submit your 1 application, first thing the NRC staff does is review 2 the application to see if we have enough information 3 to accept it for docketing.

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

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

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

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

23 And following that, our technical review 24 ultimately will result in the publication of a safety 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 45evaluation report. Which documents the NRC's findings 1 on the application and our recommendation to the 2 commission on whether we believe the construction 3 should be, permit should be granted or not.

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

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

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 46Next slide please. So I put together a 1 sample 22 month safety review timeline that's based on 2our previous reviews. And also just kind of a middle 3 ground between that 18 to 24 month time period.

4And I wanted to highlight just some of 5 what went into that so it doesn't, it isn't a complete 6 mystery of what we're doing while we're reviewing your 7 application.

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 47 So after about nine months, our goal would 1 be to have received responses from you on all of the 2 requests that we have issued. Following that, 3 reviewing the information and providing request for 4 additional information, it may be necessary to ask 5 additional RAIs.

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

10 After all of our requests for additional 11 information have been answered, and the staff is able 12 to complete a safety evaluation report, then we go the 13ACRS. And right now, in this timeline, we have about 14 19 months after accepting the application for 15 docketing, we would hold our first ACRS subcommittee 16 meeting.17 Based on our past experiences, with 18 licensing similar applications, we have seen that it 19will be likely necessary to have multiple ACRS 20 subcommittee meetings.

21 In this timeline we have anticipated there 22could be two ACRS subcommittee meetings. And these 23 can be held, essentially you would have an 24 opportunity, at most, once a month, while the ACRS is 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 48 in session, to meet with them to discuss that.

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

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

12 Next slide please.

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

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 49MR. FOWLER: And what I -- pardon the 1 interject here, but I see, you know, the objective 2 that I have in this meeting are to explore, how do we 3 accelerate schedules.

4 MR. LYNCH: Yes.

5MR. FOWLER: And I appreciate this 6 outline. There is implicit assumptions about cycles 7 in here.8 And that's an obvious opportunity to 9 reduce the overall time, if we reduce the number of 10 cycles.11 MR. LYNCH: Yes.

12MR. FOWLER: What is less clear to me is, 13what drives subsequent cycles? Is there a threshold?

14 What's the bar that we, as a company, need 15 to meet to avoid a subsequent cycle and therefore 16 accelerate the schedule? That's what's not so clear 17 to me.18MR. LYNCH: So I think that there's a 19number of things that we can do. And when we ask, 20 what we can do is, when we ask, request for additional 21 information, it's important that you understand the 22 questions that we're asking.

23You can go to the next slide. Let me 24 answer your question and then we'll go through the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 50slides as well. You can click to the next slide. But 1it's all related. That's the next topic I was getting 2 to.3 But when we issued the request for 4 additional information, it's important that after 5 they're sent to you, you have them, read through them, 6have a phone call with us. If we need to meet, we can 7 do that as well.

8 But we want to make sure that for every 9 question we ask, you clearly understand what we're 10asking. And if you don't understand, you ask us to 11 clarify.12 Because it cannot be the best use of 13 either of our times if you don't understand the 14question we're asking. You answer what you think 15 we're asking, but that's not what we're looking for, 16 then we have to ask the question again.

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 51 So I think one of the keys two reducing 1 the iterations that we have to go through in that RAI 2process, is making sure that you understand the 3 question that's being asked and providing complete 4 responses to that.

5MR. FOWLER: So we're learning how to work 6 with each other?

7 MR. LYNCH: Yes.

8MR. FOWLER: And we've had some 9experience. And, Nancy, maybe I can put you on the 10 spot here because we've now had two cycles of requests 11 for additional information with the environmental 12 portion of the technical review.

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

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

20 So in order to be productive, help us to 21 understand, from the limited experience we have 22 already, how we could do it even better on the next 23 cycle.24MS. MARTINEZ: So for the environmental 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 52 review RAIs, the second round of those RAIs were 1 driven by follow ups to the first round where the 2question was not addressed adequately. So we had some 3 follow ups on that.

4 But we also had some follow ups on the 5 responses because information was provided, and then 6 we needed additional information just based on the 7response. It was really a combination of some of the 8 questions were not answered completely, and then there 9 was responses provided, and then we had follow up to 10 that.11 We also did, you know, when we issued the 12 RAIs, as Steve mentioned, we did say, let us know if 13 these are clear and if you would like to have a call 14 to discuss them. We did that for both rounds.

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

17MS. GAVRILAS: I want to take it a step 18higher, because this is general. So you mentioned the 19two cases. Indeed, those are the two instances for 20 which we ask additional RAIs.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 53 So when they ask, when they request 1 additional information, it's designed specifically to 2augment the piece that they're writing right now. So 3that means it truly -- they know exactly what they 4want. Or they have a very clear picture of what they 5 want.6 I'm not saying that the peel the orange, 7 you know, or onion, whatever you're peeling, doesn't 8happen, but that's rare. Because of how we do, how 9 the expectation is that when you ask an RAI, you 10 basically know what kind of information you're seeking 11 to document your safety conclusion.

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

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

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

23 That is, in our experience, the most 24 efficient and effective way to deal with responses for 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 54 additional information.

1 MR. LYNCH: Nicholas?

2MR. TIKTINSKY: And I'd like to add a 3little more on that too. A lot of it's nature of the 4 rounds of questions. And this is Dave Tiktinsky.

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

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

16So really it's the nature of how the 17 information was in the application, how specific it 18 was. And really the level of what that question is.

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

22MR. ADAMS: And, this is Al Adams, I just 23 want to build on something Mirela said. That that 24 discussion that we have, once you start to develop 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 55 your answers, that's not a sort of a verbal review of 1 your answer.

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

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

15MS. GAVRILAS: And we cannot, this is 16 Mirela again, we cannot emphasize enough how important 17that dialogue is. Those are the, probably the biggest 18 contributors to our expediting the review.

19MR. LYNCH: Okay. Actually, so I think 20we've talked mostly through Slide 30. Let's go to 21Slide 31, which will continue this conversation we 22 have on impacts to schedule.

23 And this, in addition to RAIs, there is 24 other things that we can do to help ensure that our 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 56review is moving along efficiently. And can impact 1 schedule.2 One is the quality of the application 3 where all the regulatory requirements met. And this 4 is, I'm speaking hypothetically and not in your 5 application.

6 But if we do a review of the application 7 and the regulatory requirement is not met, it could 8 result in the application being rejected and needing 9to be resubmitted. Or it could result in significant 10 new information that does need to be presented and for 11 review.12Technical and completeness. Again, the 13 more information you give us without having to ask for 14 it, the more efficiently we can review the 15 application.

16 And then also just attention to detail.

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

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

22 Then building on our conversation on 23 request for additional information, in addition to the 24 number of rounds we ask, the quicker that you provide 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 57 responses to us, the quicker we can continue on with 1 our review.

2So timeliness, responsiveness, 3completeness of our requests and how you provide 4 answers to them, that can all help facilitate our 5 review.6 And I think a good point that Dave 7 mentioned was, what can take more time is if in these 8 requests for additional information, significant new 9 information is provided that we have not reviewed 10before. That can take additional time. And could 11 result in additional requests.

12MR. ADAMS: Can I -- Al Adams. Can I jump 13 in here?14 And completeness is probably the most 15important of those things. If you, you know, we asked 16 for a 30 day response and you come in in 20 days and 17 look, you know, you've come in ten days sooner. But 18 those answers aren't complete and result in another 19 round of RAIs, that round is going to consume a lot 20 more than the ten days that you saved by coming in 21 early.22 So completeness is the most important, I 23think, aspect of this. And I think what you're seeing 24 is, you know, the thing that draws out schedules is 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 58 having to go additional rounds of RAIs.

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

4MR. TIKTINSKY: Another thing I might want 5 to add too is, we're not going to wait till the end to 6give you all the RAIs at one time. You saw that, the 7 schedule that Steve had shown there.

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

12 So when we're done with an area and we 13 feel like we're done with that part of the review and 14comfortable with that, we'll ask those rounds of 15questions. But we want to spread it out over that 16 time period, the six month time period that Steve had 17 outlined.18 It's more efficient that way and it allows 19your staff to work on it. Also, we don't want to hold 20 somebody up, you know, waiting for another disciplines 21 review to be done.

22MR. ADAMS: So you may get a second letter 23 from us, but it's actually the first round of RAIs in 24that area. And there's nothing to be gained by 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 59 sitting on the RAIs and giving you a hundred questions 1 at once and overwhelming your ability to answer.

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

5MS. HELTON: This is Shana Helton. I'd 6 just like to reemphasize that when, especially when 7 you're crossing different portions of the regulations, 8 that the clearer you are in your initial submittal 9 about, this is how we're meeting 70.32, this is how 10 we're meeting 50.20.

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

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

20 I mean every applicant wants to avoid 21 going multiple rounds of request for additional 22 information. But it's just been our experience that 23 when we have to do those basic sort of questions 24 about, how are you meeting our regulations, that tends 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 60 to, once we see the detailed technical information, we 1 tend to then have questions about that.

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

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

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

6MS. GAVRILAS: More comments on RAIs.

7 Because I want to --

8MR. MORRISSEY: No, I had just a 9discussion about the technical reviews. My name, 10 Kevin Morrissey.

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

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

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

24 That would be my advice.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 61MS. HELTON: Absolutely. Getting the 1 technical experts to communicate directly so there's 2an understanding, is a good practice. To have a 3 public meeting on those RAIs.

4MS. GAVRILAS: So again, it's important to 5sum up. It's important to distinguish between various 6 increments at the same round, the RAIs and follow up 7 RAIs.8 The increments are designed to help us 9 all. To move the process along.

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

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

17 we've talked a lot about RAIs and how you can do, what 18 you can do to basically help us out, speed the process 19 along.20 But what's important in our timeline is 21 also to recognize that there's a safety reason for how 22the timeline is developed. There's nothing that's 23 carved in stone, because it's arbitrary.

24 And I'll give you, as an example, the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 62 writing of the SER. It doesn't help to distribute a 1chapter in a technical area amongst reviewer. That 2won't speed up the process. The review has to be 3comprehensive. The reviewer needs to see everything.

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

10 And with that, I'll turn it back to where 11 it was.12MR. LYNCH: Sure. Back to Slide 31.

13Again, this is Steve Lynch. Other impacts that, to 14 schedule, could be if there are policy questions that 15need to be resolved. I can give an example from a 16 past, a past review.

17 In the case with SHINE, we had to go to 18 the commission to resolve how, you know, whether SHINE 19 should be under Part 50 versus Part 70, and we ended 20 up needing to do a rulemaking in order to classify 21them under Part 50. That can be a potential impact to 22 schedule if that's something that's necessary in our 23 review.24 Also, the one thing that can drive 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 63 schedule, is the number of times we have to go to the 1ACRS. Limiting the number of subcommittee meetings 2 that we have to have, by addressing the technical 3 concerns with the ACRS, can significantly improve or 4 delay the schedule.

5MR. ADAMS: Al Adams. I just want to, the 6 ACRS tells us when they've received enough information 7 before they can write the letter they need to write to 8 the commission.

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

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

14MR. LYNCH: Yes. And what we can do to 15help them is, when they do identify areas that they 16 need additional information, that both the applicant 17 and the NRC staff provide that as quickly as possible.

18 All right, next slide please. So on the 19 previous slide I was mostly addressing the things that 20 both the applicant and the staff can do to impact 21 schedule.22 This slide is focused on the things that 23 are outside of the staff and the applicants control, 24 to a certain extent. And this gets into the hearing 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 64 process.1 And this comes after the ACRS meeting has 2 been held, the staff has completed its environmental 3 impact statement and the staff has completed its 4 safety evaluation report.

5 There will be a mandatory hearing on this 6application since it is a commercial facility. And as 7 I just mentioned, but there's a lot of things that 8 have to happen before this mandatory hearing can be 9 held.10 In addition, there is a potential, and we 11 put this out in our notice of opportunity for hearing, 12members of the public could file a contention on a 13 portion of the application or the activities that are 14 being conducted. Or proposed.

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

18 After any hearings that need to be held 19 are held, including the mandatary hearing, then we get 20 the Commission's decision to deny or issue the 21construction permit. Based on what we've seen for the 22 combined operating license applications, that have 23 followed a similar process to this, we have seen the 24 commission decision come anywhere between two and five 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 65 months following the mandatory hearing.

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

5 Next slide please.

6MR. BALAZIK: Hey, this Mike Balazik. I'd 7 like to provide a quick status update on the NRC's 8 review of Northwest construction printout application.

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

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

17 As you can see on this schedule, the staff 18 has targeted September of 2017 for completing the 19 safety evaluation report. And then there's a couple 20 of milestones that we can't really put a date next to 21 yet.22 There's a couple of related activities, 23not on this schedule, I'd like to mention. One is the 24 license amendment application by Oregon State 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 66University to irradiate three prototype targets. This 1 amendment was issued in January of 2016.

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

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

13MR. LYNCH: Okay. While we're on this 14 slide, do you have any questions about our review 15 schedule?16 I think, and this is mostly based on 17previous reviews and the sample timeline that we 18 developed. Do you have any questions on where we're 19 going?20MR. FOWLER: Well, I have an observation.

21And I appreciate this information. And I was somewhat 22 familiar with reading it.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 67 Obviously you have an ombudsman role and a review role 1 that is independent and so forth.

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

6 They see this as a real issue that we do work 7 together.8 They are not for profit organizations.

9 They have a service mission to the American public.

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

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

16 How can the NRC better set our 17 expectations of what will minimize those rounds of 18 RAIs?19 How can we work together to ensure that 20 the ACRS review is done in a single pass, rather than 21 two or three passes?

22 What do we need to do together?

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 68 But if we know what the threshold is that 1 we're trying to reach, we will work our darndest to 2get there. And that's what we're looking for. Is, 3 how do reduce the number of RAIs?

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

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

11 And that's the exploration that I'm very 12keen on hosting.

Because I think we have an 13understanding of the process. Now how do we work 14 within that process, to have the most expedited 15 schedule possible?

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

22 So this is all heading towards completing 23our draft safety evaluation report. So I guessing 24 you're looking at drive, making that June 2017 time 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 69 come up sooner.

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

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

8 MR. LYNCH: Yes.

9MR. FOWLER: You have insight by the 10 technical reviewers when an RAI is going to be issued.

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

17MR. LYNCH: There are different ways that 18 we can do this. Yes.

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

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

24 Now it also depends on the nature of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 70discussion you would like to have on the RAIs. The 1 public meetings are more necessary if we need to have 2 detailed technical discussions about the RAIs.

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

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

12So it kind of depends on what we need. So 13that can buy some time too. If it doesn't need to be 14 a public meeting, that can be done much more quickly.

15MS. HAASS: Well, and that's why there was 16 the request, when we were at the EDO, was to go get 17 that standing meeting done every week, very short and 18sweet, to say, okay, do we understand this. And then 19 we move on.

20 And so I'm glad that that got instituted 21 or executed that we're now doing that. And that has 22 helped.23 MS. HELTON: I think when you talk about 24 the frequency, the right frequency for the standing 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 71 public meetings, and they haven't been established 1yet, but we certainly can do that. And we've got 2 other examples working applicants where we've met on 3 a biweekly basis.

4 So in terms, I wanted to chat and, I'm 5 sorry, this Shana Helton, about this question on 6 threshold. And what's the regulatory threshold that 7you have to meet, as the applicant, to operate this 8 facility.9 So the regulations, we went over the 10 NUREGs as they've been supplemented by the Interim 11Staff Guidance. That is what we have set as the 12 threshold, if you will.

13 And each applicant is going to meet those 14regulations in unique ways. With that said, you know, 15we operated in a public manner. Everything is on the 16 docket.17 We've alluded to similar reviews in terms 18of looking at reducing the number of RAIs. I think it 19 would be helpful for you to do some research in ADAMS 20 for what similar designs, the types of requests for 21 additional information that we have had, and the types 22 of responses that have satisfied those additional 23requests for information. And that should really help 24 to identify the threshold.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 72 I mean that said, each application is 1different, we review it on its merits. We're going to 2 have to take into consideration the unique factors.

3 But that can at least give you a sense of the way we 4 think when we're going through these regulatory 5 reviews.6MR. LYNCH: Absolutely. I think that's a 7 very good point. And even more detailed in that, if 8 you really want to see, if you open up the safety 9 evaluation reports we write, especially those -- you 10 can look, for a good example, we just finished our 11safety evaluation report for the SHINE review. And 12 using the same guidance that you used.

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

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

24 So when we're looking at your application, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 73 we're trying to answer those questions. If we can't 1 answer a question affirmatively, that's one of the 2 times we'll go to you for a request for additional 3 information.

4 Also, as you'll realize for a construction 5 permit, you may not have all of the information that 6you would submit at the operating license stage. What 7 can also help the reviews is an explana tion of the 8information that you don't have right now, because 9your design isn't compete, explaining why it's not 10 ready right now, but also acknowledging that you 11 recognize it is something necessary for the final 12 design.13The more, again, it comes back to the 14completeness. The more informa tion that you can 15 provide us, addressing the information that we're 16looking for in the guidance, the quicker we can get 17 through the review.

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

22 However, if you can expedite the review, 23 it does make it easier if it's generally aligned with 24the guidance that we're using to go through with. So 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 74 that's some other insight.

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

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

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

17 There's security related information.

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

24 So what we try and, you know, we develop 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 75 in RAI, we try as best as we can to make the RAIs 1themselves publically available. So that information 2 is out there.

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

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

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

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

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

19But yes, we do plan things out. We try 20and coordinate that carefully with the reviewers. And 21 we know where the status of things are.

22 And again, that's why I mentioned before, 23 we're not going to just consolidate a bunch of 24 different disciplines and do it at one time, we're 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 76 going to try to phase this through, review it and try 1 to make it as efficient as we can.

2MR. ADAMS: And this is Al. I'll just add 3two things. One is, NUREG-1537 is a guidance 4 document, but it is an important document in that it's 5 a format content guide and the staff standard review 6 plan.7 What we expect for RAIs is that the RAI 8 will start by saying, either here's a regulatory 9 requirement or here's something that the standard 10 review plan is looking for, here's where your 11 application, the information in your application seems 12 to say something different or doesn't seem to have 13 this information. And then the question will come.

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

16 The other thing, you talked about the ACRS 17for similar application to yours. There are 18 transcripts of the ACRS meetings. You can go read 19those transcripts and see what areas interest the 20 ACRS, what areas they focused on, where they asked 21 both us and the applicant questions and issues that 22 became, you know, issues that were sort of follow-on 23 issues.24 So there is an advantage for you being 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 77 second in the queue that there is information that's 1 available to you. And that's an important source of 2 understanding how the ACRS works, what they think, 3 what they look at, what they consider important.

4MS. HELTON: Also publically, this is 5 Shana Helton again, also publically available on the 6advisory committee is their charter. You know, I 7encourage you to look at that. They're mandated by 8statute. They're an advisory buddy to the commission.

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

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

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

21 Sometimes they make --

22MR. LYNCH: Subcommittee does, full 23 committee does not.

24MS. HELTON: Full committee does not. So 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 78 I'm just saying, there is some limitations in working 1with the ACRS. They have a statutory role to fulfill 2 and they take it very seriously.

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

7MS. GAVRILAS: This is Mirela Gavrilas.

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

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

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

18 MS. HELTON: Absolutely.

19MR. BALAZIK: This is Mike Balazik. I 20 guess I just have one question. We've been, for the 21 environmental review, we've been through two rounds of 22 RAIs.23 We have been sharing those in draft form.

24We've offered calls. I mean, is there more that we 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 79 can do on these?

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

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

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

15And so I do think it's complete. And it's 16 sitting here for you.

17MR. BALAZIK: But it, this is Mike Balazik 18--19MS. HAASS: Now, there really isn't 20 anything else we can do accept keep communicating.

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

24MR. BALAZIK: This is Mike Balazik again.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 80 There's a difference between the weekly status call, 1 which is just overall --

2MS. HAASS: I know the staff, knowing what 3 we had and where there is a question and how we would 4go about resolving that. And it could be a public 5 meeting or it could be just, you know, there was a 6 misunderstanding and it was just a quick, you know, we 7 understood it.

8MR. FOWLER: So I see three areas that 9offer opportunities to explore expediting. The first 10I'll call administrative in nature. And those are the 11 mandatory noticing periods, the number of meetings and 12 so forth.13The better we can be in advance of 14 understanding when those need to happen, we can 15 eliminate more time that's simply waiting for one of 16 these periods. Or waiting to have a meeting.

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

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

22Then there's this area of technical. And 23 what I'm -- I've heard the term, completeness used 24 sufficiently that it will be lodged in my memory.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 81 And so -- and that comes through dialogue.

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

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

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

9 What threshold do we need to meet.

10And that's really on us. We've got to do, 11 and have been doing and will continue to do, research 12 into threshold regulatory.

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

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

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

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

24 So let me go with, as far as the status 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 82 meetings are concerned, that's our practice. So I'm 1 not sure when we implemented it, but I know that we 2 had the same --

3MR. LYNCH: We talked about it in 4November. Or no, actually August, at the National 5 Academy of Science --

6MS. HAASS: It just didn't get implemented 7 until about a month ago.

8MS. GAVRILAS: Okay. But that is part of 9our practice. To have those status meetings. But 10 their status meetings do not touch on anything that 11 Nick just mentioned.

12Okay. So as far as communication, that's 13what I was writing. The regulatory guidance is the 14 first place to look to see what the yardstick is for 15 completeness.

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

18 So they come in addition.

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

22 So we need to work together. As soon as 23 you identify a need for further discussion, you need 24to let us know. And we'll do our part in anticipating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 83 when it's likely that you will have additional 1 requests.2 Because, for example, if we know that 3 we're asking a broad reaching RAI, like Dave just 4mentioned. If we're asking you something, what was 5 your methodology, then we can see how that would 6 require an intera ction in the public to discuss 7 further.8So it's both sides. We both need to be 9aware. And I think we can both, at least we can 10 committee to our part, to have that awareness and try 11 to be proactive.

12MR. BALAZIK: Yes. And this Mike Balazik.

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

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

19MS. HAASS: And that was a little 20 different understanding. But no, I'm just glad it's 21 done.22 MR. BALAZIK: Okay.

23MR. LYNCH: So, just to finish up with 24 this slide, did we help with understanding ways that 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 84 we might be able to help accelerate the schedule in 1terms of strategy? Any other questions do you have on 2 that right now?

3MR. FOWLER: I think I have a good 4 understanding of the areas that I tried to summarize.

5 MR. LYNCH: Okay.

6MR. FOWLER: And what I would like to see 7 and what I would ask of our team is, okay, now 8translate those areas into a plan. What are the 9 processes and procedures that we've put in place, what 10 are the accountabilities, what are the milestones, 11 what in fact are the definitions of success or lack 12 thereof so we know we're on plan or off plan.

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

15 MR. LYNCH: Okay.

16MR. BALAZIK: All right, this is Mike 17Balazik, I'll continue on. We want to go through 18docketing. Steve mentioned earlier what docketing 19was. And I just wanted to go through the timeframe 20 for docketing of the Northwest application.

21 First I'll start with the Part 1.

22 Northwest submitted Part 1 of its application three 23times. Once in October 15th, another time, 29th, and 24 November 7th of 2014. This was before providing the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 85 NRC with a version that was acceptable for processing 1 and conducting an acceptance review on February 5th.

2The NRC issued a letter to Northwest on 3 January 23rd notifying Northwest its application was 4incomplete and unacceptable for docketing. Northwest 5was allowed 30 days to supplement that application.

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

8The reason for some of the delays was 9 inappropriate markings of proprietary information.

10 Also, ADAMS had rejected the document due to numbering 11 of pages.12 When they see a document has so many pages 13 and it doesn't match up, they'll reject the document 14 and try and get it resolved.

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

19And just real quick on Part 2. They 20 submitted the application, Northwest submitted the 21application, on July 20th, 2015. However, due to 22 formatting and improper proprietary markings, the 23 application was not fully put into ADAMS until 24 September 18th.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 86 The staff completed its acceptance review 1in the mid to late November 2015. And before 2 notifying Northwest on its acceptance decision, the 3staff held a public meeting in late November. And 4 provided Northwest an opportunity to clarify its 5 requested licensing action.

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

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

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

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

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

20If you begin to do that, you have restrictions and 21 limitations. Because it is a very archaic system.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 87 And we had a lot of difficulty with your 1 system that we would have two different files, exactly 2 the same thing, one would be accepted and one 3 wouldn't. And we couldn't figure out why.

4 And it was taking too much of our time.

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

8 You have a graphic capability of 300dpi.

9Our logo is more than 300dpi. And it's on every page.

10 It just isn't worth our time.

11MR. LYNCH: I believe the 300dpi is a 12 minimum, not a maximum.

13MS. HAASS: No, it's maximum. I mean 14there's some real difficulties. And we have a premier 15 person who does our documents, and I'm going to tell 16 you, it is one of the more difficult systems that 17 we've ever had to use.

18 MS. GAVRILAS: So --

19MS. HAASS: You know, I don't want to take 20this meeting over with that, and we can discuss it 21 later, but --

22MR. FOWLER: This is an area, so fully 23understand the dates. We're well aware of the dates.

24 The report that I get from my team would characterize 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 88 the difficulties differently from the way the NRC 1 characterizes the difficulties of receipt.

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

8 Now it could be us, it could be the 9 system. But let's take it off and figure out how to 10 fix that.11MS. GAVRILAS: Just a point of 12 information. Quick one. The system is designed the 13 way it is because the intent of the system was to 14enhance transparency. So that the documents can be 15 viewed on the processors that were prevalent at the 16 time at which it was deployed.

17MS. HAASS: Right. And that was the 18 issue.19 MS. GAVRILAS: So it was an optimized --

20 MS. HAASS: Right.

21MS. GAVRILAS: -- optimized two aspects of 22 our mission. One is, openness, reached the broadest 23set of stakeholders. And the other one is, making it 24easier for our stakeholders, for another set of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 89 stakeholders, the applicants and licensees to use.

1MS. HAASS: Right. I mean it is a catch-2 22, but we also had to get to a point where we did it 3 the easiest for us because it would, you know, if you 4 have to take every graphic out and do everything 5 individually and save it individually, it becomes so 6 cumbersome that you will make more mistakes.

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

10 MS. GAVRILAS: Noted.

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

15 MS. HAASS: We --

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

21 And applications like --

22 MS. HAASS: We do put a --

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 90MS. HAASS: We've tried the CD submission.

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

3MS. YOUNG: Because I know you're 4 interested in saving time. And any unnecessary --

5MS. HAASS: Yes, but we're not going to 6 solve either problem today.

7MR. BALAZIK: I think this is a good spot 8 to take a quick break. Next we'll go into Part 70.

9So ten, 15. Let's take a 15 minute break 10and start at 10:30. All right, we're going to go mute 11 on the phone and we'll be back at 10:30. All right, 12 thank you.

13 (Whereupon, the above-entitled matter went 14 off the record at 10:14 a.m. and resumed at 10:33 15 a.m.)16MR. BALAZIK: Good morning. This is Mike 17 Balazik again and we are going to resume the public 18 meeting.19 Right now we are on Slide 36, the NRC 20Licensing Process. This is, we're going to be 21 discussing Part 70 and I'll turn it over to Dave 22 Tiktinsky.

23MR. TIKTINSKY: Okay. Thanks, Mike. I'll 24 kind of make a point, my presentation is generally 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 91 more, you know, general Part 70, but I have a couple 1 of things that came up from this morning's discussion 2 that maybe will help sort of set the frame.

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

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

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

20 So that's some other ways of making sure, 21 you know -- You know, a lot of the discussion was, you 22 know, you give us a quality application, well in the 23 CP you have already given us an application, so 24 whether, you know, maybe you would have done something 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 92 different in the future, it doesn't really matter now 1 if that's already there.

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

9 So just sort of to get started on Slide 1037, just a little bit about Part 70 requirements. You 11 know, Part 70 is relatively brought up if you have 12 broad regulation to cover a whole bunch of different 13things and it talks about, you know, establishing 14 procedures for issuance of licenses, you know, to 15 title to own, acquire, deliver, receive, possess, use, 16 and transfer.

17 So that's a quite a lot of different that 18 it covers. There is a lot of activities that are in 19there related to, you know, possession and use. There 20 is the scrap recovery and licensing a fuel cycle 21 facility.22 So that's, it's a -- Again, it's a fairly 23 broad regulation to cover a lot of types of facilities 24 and activities for special nuclear material.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 93The next slide, Slide 38. It's a good 1 example here of, you know, kind of in parallel to what 2 Steve talked about in Part 50, and these, again, not 3 to, tend to be comprehensive, you know.

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

8 So if there is information that you 9 already provided for your other parts of the facility 10 you don't need to repeat them, you can just reference 11 them.12 Again, the clarity of those references 13 helps the rev iewers a lot, you know, the use of 14 crosswalks, tools, you know, whatever is efficient.

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

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

23 So, again, it's the combining of 24applications and licenses. It's not just in 50, it's 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 94 in 70, it's in other parts, so you are allowed to do 1 that.2 Again, the biggest emphasis that I will 3 have on that is regardless of the form that it turns 4 out you need to be able to demonstrate that the 5 regulatory requirements are met and the clearer that 6 is demonstrated the easier it is to get through the 7 review process and then timeliness for that.

8 70.22, the content of applications, there 9 is various requirements in there. 70.23 talks about 10 approval, so, you know, 70 is a little different than 11 50, the requirements are somewhat different, the 12 findings are different, but they are sort of still in 13 parallel to the, you know, public health and safety.

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

21The next slide, Slide 39. So NUREG-1520, 22 which is the standard review plan that we use for a 23 fuel cycle facility license application, the first 24 thing to think about is the information that's in 1520 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 95 shouldn't be, you know, that much different than what 1 you've seen in 1537, the augmented ISG, because a lot 2 of that was taken from 1520 and some of it just copied 3 for the applicable portion so a lot of it is the same 4 types of methodologies that you would use for the Part 5 70 application under 1520 or already in 1537.

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

11 The regulatory findings in 1537 talk about 12 the regulatory findings for Part 50. So that's sort 13 of where the difference t he staff in its review of 14 Part 70 applications has to make Part 70 findings for, 15so it's sort of, you know, tailored to the specific 16 regulation.

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

22 Things that are usually smooth, if you're 23 trying to go, you know, veer a lot from what's in 24 there and you have to prove it, and your case may be 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 96 difficult, it may take more time.

1Again, it's not a definite on that. It 2 is, again, depending upon what it is and what is your 3 approach and what's appropriate for your particular 4 facility.5 Following formats that match something 6that we recognize are easier. Again, the easier we 7 have to track the information that we need, the easier 8 the review goes.

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

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

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

24The next slide, Slide 40. So sort of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 97 purpose of, you know, why we even have an SRP it's, 1 you know, if you have a, it's across the board for 2 quality uniformity of review.

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

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

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

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

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

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

24 You know, Part 70, what's somewhat 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 98 different than Part 50 is, you know, the chemical-1 related hazards that are considered in Part 70 based 2on the nature of the activities that are done under 3 Part 70 facilities.

4Next slide, Slide 41. So the guidance 5 that we have in the regulations of 70.31 for issuing 6 a license, so once we determine that all the 7 applicable regulatory requirements are met we can 8 issue a license in the form and then you will have 9 conditions as appropriate.

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

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

16 We have done this for other facilities.

17 Again, it's not different than any other fuel cycle 18facility. If you look at other fuel cycle facility 19 licenses you will a series of some standard conditions 20 and then other ones that are specific to that 21 facility.22 So we would expect something to be here 23for this, this particular activity also. Even in a 24 combined license you still have license conditions 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 99 that you find in there.

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

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

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

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

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

24 How would that work within the NRC?

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 100MR. TIKTINSKY: Well part of it is, and 1 exactly where and how many documents sort of depends 2 upon how you submitted it to us, but we --

3 MS. HAASS: But it was combined?

4MR. TIKTINSKY: We would have to make, our 5 SER would have to make combined regulatory findings if 6 we were making the regulatory findings on the Part 50 7 side.8 MS. HAASS: Okay.

9MR. TIKTINSKY: We would have conclusions 10for the Part 50 part. We would have to make 11 regulatory conclusions in the same document for the 12 Part 70 part.

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

19MR. FOWLER: More pertinent to the 20 previous conversation is does one pathway offer an 21 easier, faster schedule than the other pathway?

22MR. TIKTINSKY: It's hard to say in terms 23of the speed. Clearly, the easier you can make it on 24 us to understand what you are doing and, you know, not 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 101-- Again, I should say, if there is a long time period 1 between submittals of one and the other then, you 2 know, tech reviewers that reviewed one part have to go 3 back and look at it to make sure they have covered it.

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

7MS. HELTON: If we go ahead a couple of 8 slides I think we're going to get to that, too, but 9 Dave is also going to talk about the differences 10 between the 2-step Part 50 license and the 1-step Part 11 70 license.

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

17 MS. HAASS: Right.

18MS. HELTON: There is different -- You 19 know, you have seen that the bar for the construction 20 permit, it's a different bar, you don't have a design 21 set and --

22 (Simultaneous speaking) 23MR. FOWLER: And this is why from -- I 24 have narrowed it, the choices in my mind are narrowed 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 102 to two because we have to have all of our finalized 1 design complete for the operating license under Part 2 50, which is then a 1-step process because the first 3 step has been complete, or we submit it under Part 70.

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

9 MS. HELTON: It might be helpful to step 10 forward in the slides and see if we don't address 11 that.12 MR. TIKTINSKY: Okay. Yes, see if we go 13 through and see if I answered the question or not.

14 MS. HELTON: Yes.

15 MR. TIKTINSKY: How about that?

16 MR. FOWLER: Okay.

17 MS. HELTON: Sure.

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

21 Forty-three. So to sort go with what we 22 have looked at, so from what we have received in the 23 docket so far the staff doesn't believe we have 24 sufficient information to do the conduct review of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 103 target fabrication scrap recovery activities right 1 now. So I think --

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

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

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

8MR. TIKTINSKY: We just want agreement 9 then, we all agree that there is not, we don't believe 10 there is sufficient information.

11 And from our review of those activities, 12 you had mentioned in your application that you 13 believed they were under Part 70, so how we look at 14 them they, I guess the first part is they don't appear 15 to be covered by Part 50, so that's sort of, it's not, 16 it doesn't meet the definitions of production facility 17 under Part 50 and they appear to be subject to Part 18 70.19 So that's sort of our looking at what --

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

24 And for us to actually conduct, you know, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 104 the safety review and issue a license, because 1 obviously you would need to submit an application 2 meeting all the regulatory requirements.

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

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

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

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

18Again, going back to my first point of 19 making sure there is a good understanding of things 20 because for any facility pretty much in, or activity 21 in Part 70, there are some parts that apply and some 22 parts that don't apply just on the nature because Part 23 70 is a broad regulation.

24 You can, you know, control things like MOX 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 105 facilities, which is different than, you know, uranium 1 enrichment facilities, so there -- But the regulation 2 is written broadly, so, you know, your understanding 3 of what you think you need to meet, having discussions 4 on that would probably be useful to make sure we were, 5 you know, had some alignment, you know.

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

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

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

20The Slide 44 talked a little bit about 21 schedule and, you know, Steve had presented a schedule 22 to you, and that was a very good outline of the types 23 of activities that get done in a review, so what I 24 present here is sort of, you know, if you were just 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 106 submitting a Part 70 application this is what we would 1 tell you that, you know, it's typically about 18 2 months to do a review.

3 We do a technical review of the 4application. Again, whatever it was, if it was 5 submitted with the Part 50 or not we will do a 6 technical review of the applicable regulatory 7 requirements, issue additional requests for additional 8 information, draft a safety evaluation report, you 9 know.10 There is slight differences in terms of, 11 you know, the process and terms of, you know, there is 12 not a mandatory hearing for this type of facility in 13Part 70 compared to 50, so there's some, you know, 14 subtle differences.

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

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

23 If it's with it then we could do that 24 review in parallel, so it wouldn't be adding to the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 107 time.1 So, again, a lot of it depends upon where 2 you want to submit it, what is strategic, you know, 3 for your company, when you think you are ready to have 4 all the requirements.

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

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

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

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

22MR. LYNCH: And just to add on, and I 23think Dave is absolutely right. I guess what it comes 24 down to, I'm glad we're in agreement on the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 108 information itself that needs to provided and I think 1 that the main comment in terms of what's more timely, 2 the sooner we have the information the sooner we can 3 begin reviewing it, if that helps you in planning when 4 you submit.

5 But I think from a Part 50 standpoint it's 6 important to think about, also, that is there still 7 related activities that are happening under the same 8 roof.9 So in order for us to make our safety 10 findings under Part 50 for a production facility we 11 will be interested in how other activities happening 12 within that building could impact, and I'm sure it's 13 the same going both ways.

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

21MS. HAASS: Well and that was the concept 22 of our Part 1, Part 2 submission was we showed an 23 overall facility, because you are trying to show all 24 the safety-related activities, you know, and how they 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 109 interact with one another.

1 MR. LYNCH: Yes.

2MR. TIKTINSKY: Yes, it sort of emphasizes 3--4 (Simultaneous speaking) 5MS. HAASS: But I can't do one without the 6 other?7MR. TIKTINSKY: Yes, to emphasize Steve's 8 point, I mean we, you know, individually look at the 9 Part 50 portion of the facility we need to consider, 10 you know, an external, which isn't really external in 11 this case because it's maybe the room next door.

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

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

22MR. JOHNSON: So, Nick, did that answer 23 the question that you asked a couple slides back about 24 are there efficiency -- What a thought your question 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 110was, are there efficiencies with going one route 1 versus the other, submitting a separate standalone 2 Part 70 versus incorporating all of the, how you are 3 satisfying all of the requirements into the CP, is 4 that what you were asking?

5MR. FOWLER: Yes. And, further, is there 6 a material difference between the strategy of 7 application submission?

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

14In many companies it would be easier to 15 have a separate Part 70 application because some of 16 the conversations could be more easily 17 compartmentalized even though they do relate to other 18 things.19 What I concluded, rightly or wrongly, 20 there is not a material difference. And to be clear 21 from what's in my head there is a 2-month difference 22 right now between the critical path of us entering the 23 supply chain with quantities of moly under Part 50, a 24 2-month slip on the Part 70 puts Part 70 on the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 111critical path. That's how tight these two things are 1 together.2 Plugging in all of the assumptions from, 3 well the guidance that we receive from the NRC, there 4 are only two months d ifference right now and so if 5 there were a material difference in review process 6 cycle time it could very easily affect the entrance of 7 this critical isotope into the supply chain.

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

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

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

23 I've seen another complex application, I 24was in operating reactor licensing before this job, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 112 where, you know, we've had as many or seven or eight 1 pre-application meetings to talk about each of the 2 different technical chapters and what they're going to 3 be doing to meet the requirements, and you might want 4 to consider doing something like that just so there is 5 no surprises.

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

9 MS. HAASS: Yes, so --

10 MS. HELTON: Yes.

11MS. GAVRILAS: So just one reminder. This 12is Mirela again. Just one reminder that these are 13 estimates, the timelines, and we try to walk you 14through the parameters, that impact held with that 15 estimate that --

16 So it's almost like you are talking 17 project management, what we visualize in our mind is 18 sort of Gantt chart with the end in mind, you know, 19 how the review of these various activities basically 20 lead towards the point that which you get an operating 21 license.22MR. BALAZIK: This is Mike Balazik. Is 23 there any other questions on the Part 70 piece, 24 because now we're going to shift to something else?

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 113MR. ADAMS: And now for something 1 different.

2 MR. BALAZIK: All right, Al.

3MR. ADAMS: So what I'd like to do is, you 4 know, we have discussed the, you know, general 5 requirements for licensing, your proposed activities, 6 you know, we discussed where the current status 7 review.8 Using your cover letter for Part 2 of the 9 application and the NRC reply I'd like to try to pull 10 everything together and hopefully the goal here is to 11 reach a common understanding of how to move forward.

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

17 So, next slide. So, you know, here is I 18 think probably the most important statement from, well 19 one of the important st atements from your cover 20 letter, that you are applying to the NRC to obtain a 21 license for a production facility under 10 CFR Part 22 50.23So, next slide. So I think, you know, we 24 understand that statement that you are looking for a 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 114 construction permit for a production facility, you 1 know, to dig a little bit deeper that you are looking 2 for a license to construct a facility where you plan 3 to conduct activities to separate moly-99 from 4 irradiated uranium and other byproduct material.

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

7 There is three basic definitions of production 8 facility.9 One is facilities that are involved in the 10 formation of plutonium, basically plutonium production 11reactors. The other one are facilities that are 12 primarily separating plutonium, and there is the third 13 definition which is on the slide, any facility design 14or used for the processing of irradiated materials 15 containing special nuclear material.

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

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

24MR. ADAMS: And there is, you know, there 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 115 is a safety reason behind the definition and that's 1 when you are processing irradiated materials 2 containing special nuclear material basically you are 3 separating out fission products from irradiated 4 special nuclear material.

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

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 116 The other one is if you are, that if your 1 batches are less than 100 grams of uranium then it's 2not a production facility. You indicated that your 3 batches will be greater than 100 grams of uranium.

4 And the third is that if the irradiated 5 material that the fission product concentrations and 6 the plutonium concentrations are less than the cutoffs 7 in the definition then you are not a production 8 facility.9 So you indicated that you are not looking 10 to fall under any of those exceptions, which means you 11 are a production facility under Part 50.

12Next. So here is another statement in 13 your letter to us.

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 117 Okay, now Slide 49.

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

5Slide 50. So just to repeat what 50.31 6 and 50.32 say, so the regulations in Part 50 allows 7 combining of applications under Chapter 1 of 10 CFR 8 and Chapter 1 is all of the NRC regulations, so we, 9 you know, so applications can be combined.

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

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

19 MS. HAASS: Correct.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 118 NUREG-1537 has a couple of statements that 1 are applicable to what you are proposing on doing 2here. Section 9-5 of NUREG-1537 contains guidance 3 that materials used in the production facility license 4 need to meet the regulatory requirements for that 5material. In other words, special nuclear material 6 needs to meet the regulations in Part 70.

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

11Fifty-two. So your cover talked about 12 embedded in the 10 CFR 50 license facility activities 13 under Part 70 and Part 30.

14Slide 53. As I mentioned, as discussed in 15 Section 9-5 of NUREG-1537 the Part 50 license can 16 include other activities, however, the issuance of a 17 Part 50 license doesn't automatically include other 18 activities, other licenses.

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

23 So I think as we said several times, at 24this time we don't believe that your construction 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 119 permit application has the information required to 1grant the additional licenses and I think we're 2 looking for a better understanding of what you mean by 3 when you say "embedded activities." 4Next slide. So this is an example of a 5Part 50 utilization of an operating license. We call 6them included activities. What I am looking for is to 7 understand if our included activities are the same as 8 your embedded activities.

9As you can see in this license the 10 different licensing clauses. Number 1 on this slide 11 that is the license for the facility, so that's where 12the license is granted for the Part 50 facility. This 13 is an example of a Class 103 license, which is similar 14 to the Class license you are looking for.

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

19 And so Number 2 is you see an included 20 activity, so you can see this is the Part 70 clause so 21 the included activities to receive, possess, and use 22 at any time special nuclear material, in this case 23 it's reactor fuel in accordance with the limitations 24 for storage and the amounts required for reactor 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 120 operation as described in the application.

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

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

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

17So, 55. You mention that the RPF will 18 include the fabrication of LEU targets which will be 19 licensed under 10 CFR Part 70.

20Fifty-six. So, you know, we understand 21 that, you know, you understand that the fabrication of 22 targets is under 10 CFR Part 70 as we discussed 23 several times and this was reflected in our docketing 24 acceptance letter which stated that staff expects that 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 121 and Northwest will submit an application for 1 fabricating low-enriched uranium targets under 10 CFR 2 Part 70.3 And next is 57 --

4 MR. FOWLER: So I want to --

5 MR. ADAMS: Yes?

6MR. FOWLER: Al, I I'd just to clarify 7 that.8 MR. ADAMS: Sure.

9MR. FOWLER: Part of what triggered a 10 serious of conversations was the meeting immediately 11 preceding Thanksgiving in which our internalization of 12 the communication was a requirement to bifurcate our 13 application between Part 50 and Part 70.

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

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

24MR. ADAMS: It's still that type of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 122license, but, you know, there is choices on how you 1 put in your application, there choices on how the 2 license looks.

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

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

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

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

15MS. HELTON: Yes. Just to add to that, I 16agree. This is Shana Helton for the phone. The point 17 I think back at the Thanksgiving meeting that is being 18 reinforced today is that we need to see something from 19 you that demonstrates compliance with the requirements 20 in Part 70.

21 MS. HAASS: There was --

22MS. HELTON: Right. So I think that's --

23 (Simultaneous speaking) 24MS. HAASS: Right, but there was never any 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 123 disagreement with that when we were socializing it 1 when we had originally sent our letter over a year 2 ago.3 MS. HELTON: Right.

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

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

13MS. GAVRILAS: This is the main objective 14of this meeting. We need to make sure that all the 15 areas where there is uncertainty, where we are not 16 aligned, today is our opportunity to address them.

17 You know that's why we exchanged the 18 topics that we covered today with Carolyn before the 19 meeting to make sure that everything that we are 20 presenting here does address your concerns and does 21 actually get us to the point to which we can align on 22 the things that have some uncertainty associated with 23 them.24MR. FOWLER: And so to that point I see 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 124 everyone's head nodding that we are now in alignment 1 with respect to the previous kind of crosswise 2communications on 70 and 50 and for that we can 3 successfully tick off that as we have met that 4 objective of the meeting.

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

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

11MR. ADAMS: And I think I have one more 12slide. Number, I think Slide 57. So that the current 13 application that you are not, at this point you are 14 not seeking an operating license for the proposed 15 facility.16 This is a discussion we would like to have 17 with you today to the extent, you know, that we can 18 have it as to what your plans are for submitting your 19 operating license application because that does 20 influence timing, that does influence, you know, what 21 we do on, you know, what we need to do and what you 22 need to do, too.

23 So, you know, that's an area that we need 24 to, that we'd like to understand better for, we're 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 125 prepared.1 The second point, current application does 2 not request a license to produce SNM for the 3 fabrication of LEU targets, I think we beat that one 4 into submission.

5MS. HAASS: Well it doesn't, it's not a 6 current operating license application.

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

8 MS. HAASS: It's Part 70.

9 MS. HELTON: Right.

10MR. ADAMS: Yes. That's right, and that's 11 a separate point from my first one.

12 MS. HAASS: Right.

13MR. ADAMS: And a facility can have 14 multiple licenses, that a single building can be a 15 place of use under multiple licenses.

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

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

24 MS. HAASS: Yes.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 126MR. ADAMS: So that's the important thing, 1 but there is no rule that says that, you know, a 2 certain piece of turf can only, you know, can only be 3 occupied by one license, and I think that is 4 consistent with what we have discussed today.

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

11 That's it for me.

12MR. BALAZIK: All right. Real quick, this 13 is Mike Balazik again, and I know we have touched on 14 some of these topics but I just want to reemphasize 15 them.16 On communications, that internal and 17 external communications is important to support a 18quality and timely application review. I just wanted 19 to go through some of those channels that we have 20 already set in place.

21 One that Shana mentioned early in the 22 meeting about essentially one-stop shopping, that I am 23 your contact even though you've got, down the road 24 there is potential licenses, I am your main contact, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 127and, you know, on a lot of our calls, on our weekly 1 status calls I'll have Dave and Nancy on those calls.

2 The next item, clarifying, calls for REIs.

3 We've done a couple of those for the environmental and 4 we plan to continue those for the safety, sharing 5 those RAIs with you draft form, make sure there is an 6 understanding, and if there is not, you know, we can 7 discuss it and even modify the RAIs so that it is 8 clear.9 Since we are discussing RAIs I'd just like 10to share one item for thought going forward. Even 11though there is no regulatory requirement to update 12 your PSAR, we've seen a good practice, or identified 13 a good practice that if you update your PSAR with the 14 RAIs that that can also lead to a timely review, but 15 even future steps it will help us, to keep your 16 updated PSAR.

17 But realize there is no, you know --

18MS. GAVRILAS: I'll just mention one 19thing, ACRS. It's easier for the ACRS, we accept your 20 responses, right, as a supplement to your submission, 21 they become part, they are docketed and they become 22 part of the docket.

23It makes it much easier when the ACRS 24 looks at the package to have the package as complete 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 128 as possible.

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

4MS. HAASS: So a good example is the RAIs 5we have received on Chapter 19. We've already updated 6Chapter 19. You have not received it, but we have 7 already updated it.

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

14 MS. GAVRILAS: That's terrific.

15MR. TIKTINSKY: The practice that we find 16 that works a lot is sometimes, you know, answers to 17 RAIs are long but changes to the applications don't 18 necessarily, aren't -- Well you might change one thing 19 in an application and have a 3-page thing backing it 20 up.21 MS. HAASS: Right.

22MR. TIKTINSKY: So at the end of the day, 23 at the end of the review it's good to have one 24 application that we know everything that's in the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 129 application that we can write an SER against rather 1 than writing SERs against all these little sort of 2 sidebar discussions.

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

7MS. HAASS: But remember it's difficult 8 for us to manage if we don't do that. That makes us 9 inefficient, so it's only good practice on our part 10 and to move forward to the operating license.

11MR. TIKTINSKY: That could be changed 12pages, you know. It doesn't have be, you know, every 13 time you make something it doesn't need a whole 14 chapter, it's just whatever related to, you know, the 15 change from an RAI and is, you know, and you manage it 16 however you find most efficient.

17MR. BALAZIK: All right. Another item, 18 responsiveness, we've also talked about that, 19 especially timely response to RAIs and when we share 20 the draft RAIs if there is something that you see in 21 there that you can't get in 30 days or a certain 22 timeframe just let us know.

23 Let us know that this, hey, we can answer 24 RAIs 1 through 5 but, you know what, six is going to 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 130 take us a little bit longer. You know, we just need 1 that communication back and forth that there may be 2 something up there that may take a little bit longer.

3 Quality of submissions, we also talked 4 about this, identifying proprietary information, 5 removing that, and just that answers are complete.

6 Also, just clarify previous communications 7or socializing. We mentioned this earlier that no 8 regulatory decisions are made in public meetings and 9 that public meetings are not a substitute for 10 submittal of information on the docket and also that, 11 you know, we don't make decisions on our weekly calls.

12 And, finally, just that the NRC has an 13 opening policy and if we chose to close a meeting, you 14 know, it's reserved for informa tion that must be 15 withheld in accordance with our regulation.

16 So that's pretty much it for 17communications. I don't know if anybody else wants to 18 add -- Yes?

19MR. LYNCH: I just wanted -- I was really 20glad to hear that we were able to meet one of your 21 objectives in terms of licensing, that we have a 22 shared understanding that additional technical 23 information is needed for, to meet Part 70 24 requirements and how you choose to submit that is up 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 131 to you and regardless of how it is submitted it's 1 still the same technical information that we are 2 looking for. I'm glad we've got that objective met.

3 I want to make sure that we can also 4 hopefully meet that second objective that you stated 5 at the beginning, which was exploring mechanisms to 6 expedite the review.

7I tried making a summary. I think Mike 8highlighted them and I just kind of want to read 9 through those again and make sure that we understand 10 everything you are looking for and to reiterate our 11 points that can help facilitate that expedition.

12One of those areas we've talked a lot 13 about, RAIs, trying to reduce the number of rounds of 14 RAIs and even the total number of RAIs, things that 15 can go that, the quality of your responses, 16 completeness and the timeliness, we explore different 17 ways of communicating that to help facilitate that.

18Mike has his weekly status calls. We have 19 talked about -- and on the status calls we can make, 20talk further about if we want to set up standing 21public meetings. If that can help we can certainly 22 get those set up as well.

23 And broader with communication, you know, 24those weekly status calls are good opportunities to 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 132 identify problems you see coming down the road that 1 we, both parties can be thinking about and, you know, 2 maybe it's not something we address immediately, but 3at least we can put them on the list of things NRC 4 needs to think about and things that Northwest needs 5 to think about, and they can topics of future public 6 meetings.7 We can also talk about, you know, email 8communication works, too, send emails. You can update 9and propose topics that we can have on those weekly 10 calls, topics for public meetings, if we can get 11 those, and it helps, too, we can discuss ahead of time 12 before we have those calls.

13 Al touched on this, also that's important 14to us is updates to your schedule. This can be 15 updates as Mike was talking about with responses to 16 RAIs.17 If it's going to take you a little bit 18 longer to get certain responses to us work that out 19 with Mike, let us know what's going on with your 20 schedule so that we can plan and make sure that we 21 have people available and ready to review your 22 responses when they come in.

23 Also, when you plan on submitting 24 additional applications, primarily your operating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 133 license application, helping us have a good idea of 1 when that's coming in to make sure that we have people 2 ready to review it when it comes in.

3 So letting us know delays that might come 4 up or if your schedule is getting pushed up, it helps 5 us align our budget and our resources to make sure 6 that we are ready for your application.

7 We also talked about pre-application 8meetings. So when you are getting ready to submit 9 your next application for your operating license we 10 can have meetings ahead of that submission to make 11 sure that we have a shared understanding of the 12 information that's coming in that and have discussions 13 about that so it helps encourage that a quality 14submission comes in for your operating license and 15 could help potentially reduce that review time as 16 well.17 In talking about the operating license 18 application I wanted emphasize again, because 19 ultimately we complete this construction permit review 20 in our 18 to 24-month timeframe, we're still 21 anticipating an additional 18 to 24-month review for 22 the operating license application, and I understand 23 it's critical that we can get that review done 24 efficiently as well.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 134 So I think for those exploring, those pre-1 application meetings can be a good way of getting us 2 started on that review and knowing when it's coming in 3 can help us be prepared.

4 We highlighted following the guidance.

5 You can gain insight from NUREG-1537, the ISG, our 6 standard review plan, so you know exactly what the NRC 7 is looking for when we review the application that you 8 sent in, also looking at past applications that have 9 come in to get ideas of questions we have asked in the 10 past and the level of detail of information that we 11 found acceptable in the past.

12 We also talked about reducing 13 administrative time so that we don't have time that's 14 spent with people not doing anything, and I think 15 that's good and I think those weekly calls, again, are 16 going to be crucial to reducing that administrative 17 time for processing.

18 And Mike highlighted again at the end 19 updating the application as you are responding to 20RAIs. That was my list. Were there other things that 21 I missed that we can --

22MR. ADAMS: There's probably one I want to 23touch on. I think I touched on it briefly and that's 24 the operating license application.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 135 The last research reactor that we licensed 1 submitted a complete application at the construction 2 permit stage so our review was for both the 3 construction permit and the operating license at the 4 same time.

5 Obviously, that has the potential to, you 6 know, reduce the review time significantly so that's 7 why we are interested in knowing what's your timing on 8 your operating license that, you know, that has an 9 effect because, you know, the theory is that the 10 construction permit you've given us so much of, say, 11 you know, your complete design that you've given us so 12 much of that design and, you know, there is enough 13 there to make a decision to allow the facility to be 14 constructed and then the rest of the details on the 15 design come in with the operating license that, you 16 know -- so there is a lot of variability what that, 17 you know, what those parts, you know, what those two 18 parts look like.

19 The first part is here, you know, what 20 needs to come in to fill and, you know, to fill in the 21 rest of the information and when that information is 22coming in I think is important, you know, in the 23 discussion of, you know, how to change the, you know, 24 the timing of this and, you know, not only, you know, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 136 talking talk the timing from, you know, the beginning 1 to you have an operating license.

2MR. TIKTINSKY: If I add a little emphasis 3 from Steve's point on the Part 70 side, you know, 4 there is many examples of the kinds of the RAIs that 5 we have asked for Part 70 applications as well as 6 SERS, so you can sort of see when we write up things 7 related to 1520 what the kind of things we're looking 8 for, the kind of questions we had.

9 And, also, you know, emphasizing of the 10 use -- You've got multiple things here, the use of 11 crosswalks, you know, again, the clearer that you can 12 make it that we understand where the information is 13 the easier it will be for the reviewers to get the job 14 done and minimize questions of because we just can't 15 find information.

16MR. FOWLER: So to the list that Steve 17 summarized very nicely I would add a program/project 18 management process, just as I manage a program inside 19 of a private company I have far less insight into the 20 detailed activities in what's happening at the NRC and 21 whether we're on track, off track, what are the 22 constraints, what are the barriers, those kinds of 23 things.24 So a consolidated program project 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 137 management structure I think is very, very important 1 to keep things on track.

2 MS. HAASS: Yes.

3MR. LYNCH: And I think to that, yes, I 4 think it's very important from both sides to keep each 5 other updated on where we are at in our reviews and I 6 think with the calls we can do that.

7 Also, what we're going to try doing is, 8 you know, keep you updated on our overall review 9 schedule. We have this initial review schedule that 10 we shared here today on our slides, but as things come 11 up that may necessitate that changing, either 12 expedited or delays, we need to communicate that to 13 you as soon as possible, and that's a commitment that 14 we can make as well.

15 We are also going to, you'll be seeing 16 shortly, we're working on developing a public website 17 that should be going live in the next couple weeks 18 that you can be able to also have all of your 19 application data displayed as well, that can be easily 20 accessed and see our review schedule.

21 MR. ADAMS: The public --

22MS. HAASS: The public would -- Sorry.

23 For Northwest Isotopes or for other things as well?

24 MR. LYNCH: Both. So Northwest specific 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 138 and general moly-99.

1 MS. HAASS: Okay, got it.

2 MR. ADAMS: And your public information, 3 not your --

4 MS. HAASS: I understand.

5MR. LYNCH: But, yes, and, you know, as we 6 continue with the review I'm sure both sides will have 7 new ideas.

8 MS. HAASS: Yes.

9MR. LYNCH: So chair them and we can 10 continue to improve.

11MR. BALAZIK: All right. At this point 12we're a little ahead of schedule. Our senior managers 13 want to come down for our closing remarks and summary.

14 The timeframe for that is 2:30, but I 15 wanted to ask Northwest if they had additional 16 discussion they want to do in the afternoon on any of 17 the topics we presented, any topics that we didn't 18 present today that they would like to discuss in a 19public meeting. I've got that scheduled for 1:30 and 20 lasting about an hour.

21 MS. GAVRILAS: Yes, I have a suggestion, 22 that we mull over everything we have heard and perhaps 23after lunch we reconvene and that will be the time, 24 unless you want us to research something over lunch.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 139 It's going to be after lunch we reconvene 1 and we sort of discuss any outstanding items, how's 2 that?3 MS. HAASS: That's fine.

4 MR. FOWLER: Sounds good.

5MR. ADAMS: And another question, is, you 6 know, giving us information on where you see your 7 schedule moving forward, you know, especially giving 8 us the operating license application, is that 9 something that you are prepared to talk to us today in 10 this swarm or --

11MR. FOWLER: We would certainly be 12 prepared to respond and provide some answers in a non-13 public format, as it's dependent upon a lot of the 14questions that were asked of us that are of a 15proprietary nature to come up with the anticipated 16 scheduled.

17 MR. ADAMS: Okay.

18 MR. BALAZIK: Okay.

19 MS. GAVRILAS: Enjoy lunch.

20 MR. BALAZIK: Yes.

21 MR. ADAMS: What time --

22 MS. GAVRILAS: We'll reconvene at --

23MR. BALAZIK: Well let's reconvene at 1:30 24 for discussion of additional topics and then at 2:30 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 140 we'll do the closing remarks.

1MS. GAVRILAS: Yes. And we have an 2 opportunity before the public to --

3MR. BALAZIK: Yes, we're going to do that, 4 too, yes.5MS. GAVRILAS: So we need to stick to the 6 agenda because --

7 MS. HAASS: Is there any opportunity for 8 a non-public portion of this?

9 MR. BALAZIK: No, there is not.

10 MS. HAASS: Okay.

11MS. GAVRILAS: So we need to stick to the 12 agenda because the agenda is made available so that 13 everybody can listen, so we'll just meet back at 1:30 14 and we'll talk more then.

15 MS. HAASS: Right.

16 MR. FOWLER: Very good.

17 MALE PARTICIPANT: Thank you.

18MR. BALAZIK: This is Mike Balazik. We'll 19 be coming back at 1:30 and we're going on mute until 20 then.21 (Whereupon, the above-entitled matter went 22 off the record at 11:32 a.m. and resumed at 1:35 p.m.)

23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 141 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 1 (1:35 p.m.)

2MR. BALAZIK: Hi, this is Mike Balazik, 3 and we want to resume the public meeting with 4 Northwest Medical Isotopes. Right now in the agenda 5we have Northwest Medical Isotope topics. If there's 6 anything that Northwest wants to discuss with the 7 staff?8MR. FOWLER: We did not have topics in 9public form. We'll arrange a separate non-public 10 meeting to discuss some topics.

11MS. GAVRILAS: Mike, you want to talk 12 about the setting up closed meetings please, because 13 apparently there was some miscommunication on what 14 requirements we must need before we can do that.

15MR. BALAZIK: Yes, the requirements for a 16 closed meeting is to submit an affidavit with the 17 letter, but with the specific topics that are going to 18 be discussed in the closed forum.

19 So then what we would do is we would look 20 at those topics and agree that yes, these are proper 21 to be discussed in a closed setting vice an open 22 public meeting.

23 So in the affidavit that was provided, I 24 felt that it was very general, and I received some 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 142 advice that it did not contain sufficient detail to 1 close the meeting.

2MS. HAASS: And as discussed with you, we 3 were, we didn't quite know what would be in the non-4 public forum because this discussion had to occur and 5that's why it was general. So it's not that we didn't 6 understand, it was because of how the meeting was set 7 up.8MS. GAVRILAS: I understand. So the other 9 thing that we tried to see is if it's okay for us to 10close a portion of this meeting. So that was the 11homework we did during lunch. And we were advised 12that that's not okay because the topics need to be 13 submitted by affidavit. So we tried.

14 MS. HAASS: It's a catch 22.

15 MS. GAVRILAS: Yes.

16MS. HAASS: But no, we do understand, you 17know, the requirements for a non-public meeting. But 18 we just didn't have enough data to be able to give you 19 any more specifics.

20MR. LYNCH: That's understood. Well 21 maybe, if we have some time maybe we could use for 22time our over here is to maybe make a list of some 23 action items that we can take for going forward, and 24 this could include topics for future meetings that you 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 143 might like to have, things you would like to see, and 1 other things you would like to go forward on both 2 sides that we can take back and then we can get back 3to each other on. Does that sound like something you 4 would like to go over?

5 MS. HAASS: I would say we can take some 6action items. But just as long as we know it's 7 subject to change because, you know, I still have some 8 discussions I need to do.

9MR. LYNCH: Understood, understood. Yes, 10this is not meant to commit you to anything. This is 11 intended to help us get an idea of when we leave here 12 today what should we be most focused on, aside from 13 reviewing your application.

14 Mike, did you want to lead with any topics 15 there?16MR. BALAZIK: One thing we've discussed 17 before, and again stop me if we're going into 18proprietary information. But one thing we've 19discussed in the past is facility design, final 20 design.21 And what we've talked about earlier are 22 our resources for future applications, future 23submittals. Is it possible we could get some sort of 24 idea of how far down that path Northwest is?

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 144 MS. HAASS: I think we can state that we 1are in the process of finishing our final design. But 2 from a schedule perspective, that would have to be 3 discussed in a closed session.

4MR. LYNCH: Yes, I think the topic from 5 that is what, something the NRC is interested in 6 understanding better from you is when will your final 7 design be complete, and also how do you think you 8 might consider submitting that because there are 9 different ways that the final design can be provided 10 to the NRC.

11 The final design can be provided as part 12 of your operating license application, or you can 13 amend your current construction permit with additional 14 design information as you finish it.

15 And however you choose to do that is fine.

16 But it does help us to anticipate when that 17information might be coming in. So that's just, that 18 is a topic that would be useful for us to discuss in 19 the future.

20MS. HAASS: Well, and I would be 21 interested, because this is the closed question, what 22have you preferred in the past? Would you like to see 23 it, like, you know, before the operating license 24 submission with the, maybe the finalization of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 145 construction permit.

1 I mean, I don't know. I mean, I don't 2 know what's the best timing for you guys I guess I 3would ask. And then, you know, we'll try and work 4 that into a schedule.

5MR. LYNCH: I think for us, you know, 6 we're willing to work with you with whichever way you 7would prefer. You know, we haven't done something 8like this in a very, very long time. So I don't know 9 if there's a lot of precedent we can necessarily point 10 to.11 But I think we want to work with your 12proposal. And by notifying us when it's coming, we 13 can make sure we have the appropriate resources 14 available for that.

15MR. ADAMS: This is Al. I think, you 16know, the understanding of the timing is important 17 because we're going to, you know, spend time and 18 effort reviewing what you've given us.

19 And if we're 85 percent complete with that 20 review and all of a sudden we have a whole new bunch 21of information, it might be advantageous to finish 22 that 15 percent, take that licensing action and then 23try to reset, try to, you know, blend those two 24together and start reviewing sort of an expanded 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 146 scope.1 So you know, part of it depends on the 2 timing versus if we're only, like, ten percent into 3 looking at something and the new information comes in, 4 then the effort or cost of changing your direction, 5changing your scope is minimal. So I think that's an 6 important solution.

7 MR. LYNCH: Maybe that's a better way to 8capture what we can provide that too. We won't advise 9you on which way is better than the other. But we can 10 discuss, as Al was going to, what potential impacts of 11 your decisions could be.

12MR. BALAZIK: This is Mike Balazik. I 13 guess another potential item is exemptions. I don't 14 know if Northwest has looked at any potential 15 exemptions that could come down the road that we could 16 be aware of or could prepare for, just kind of another 17 item that would benefit us in future reviews on 18 exemptions.

19 MS. HAASS: Okay.

20MR. LYNCH: And even more broadly, just 21 other licensing actions in addition to your primary 22 construction permit or operating license, or material 23 license and application that we might need to consider 24 and the timing. And for example, that could include 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 147 the other research reactors that might be seeking 1 amendments to support that, knowing the timings that 2 those licensing actions can help us as well.

3MR. ADAMS: Another example would be if 4 there's any need for shipping packages that would be 5 unique to what you're doing that, you know, don't 6exist. That's another part of NRC and that's, you 7 know, a discussion that they have their own timelines 8 for doing that type of work.

9MS. HAASS: And we've had brief 10 conversations with the other organizations, too.

11 MS. YOUNG: And that's under Part 71.

12MR. LYNCH: Another topic that, you know, 13 that I think we could discuss going forward to our, 14 we've touched on the topic of potentially setting up 15 standing public meetings.

16 Put that on the list of establishing if 17 that's something that you want to pursue, what you 18 think appropriate frequency for those meetings might 19 be, what topics you might want to discuss during 20those. I think that, I took that as one of the take-21 always I had from earlier today as a topic we should 22 explore further.

23MR. BALAZIK: I guess, this is Mike 24 Balazik again, for expectations for interactions with 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 148 the NRC for the environmental review, we're pretty 1much had a set process. I mean, is there any 2 recommendations on communications that you would like 3 to see in the future?

4MS. HAASS: Just want to make sure that 5 the RAIs get reviewed prior to going out final to make 6 sure there's no business sensitive information in 7there. If you can at all let me know the possible 8 timing when that's going to come in, you know, we have 9 a lot of things going on as well and I need to make 10 sure our resources are there.

11 And I know when we get into the safety 12 aspect it can get more and more difficult, you know, 13 to get those reviewed, and what resources that means 14 to us as well.

15 Also from, Nancy, from your perspective, 16 I mean, you'll have another public-type meeting within 17the NEPA realm. And you know when you're going to be 18scheduling that. I know that the City of Columbia was 19 asking me that question as well.

20 I just know, you know, they told me they 21 would really like to help you do that. And I know 22 last time you guys went and did that, you know, 23 independently which is fine, but they're also willing 24to go help as well.

And, you know, you have their 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 149 contact information now.

1 MS. YOUNG: Okay, thank you.

2MR. LYNCH: Were there any topics that 3 you've had in mind in addition to that that you would 4 like to focus on in the future?

5MS. HAASS: No. I think when you start 6 looking at schedule, the other licensing actions and 7 the same in the public meetings, that's really where 8 we want to focus with you guys.

9 Obviously, the standing public meetings, 10 you know, we'll assume that there will be some closed 11 portions of those meetings within that, you know, with 12 the appropriate documentation, understand that.

13MS. GAVRILAS: Mike, you'll need to 14elaborate on the process. I think we need the 15 affidavit with sufficient detail --

16 (Simultaneous speaking) 17 MS. HAASS: Oh, that's what I just said.

18 Right, no --

19 MS. GAVRILAS: So that's --

20MS. HAASS: I said with the appropriate 21 documentation there would be closed portions as well 22 because there are certain things that, you know, that 23 are technically sensitive as well.

24 MS. GAVRILAS: Sure.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 150MS. HAASS: And so any time we have a 1 topic, assume that there's going to be some, there's 2 most likely going to be something business sensitive 3 in there if it has anything to do with some details of 4 the facility.

5MR. TIKTINSKY: You don't want to forget, 6 Dave Tiktinsky, the security related information 7 aspects of public meetings with technical discussions 8 which is different because that's a different part of 9 the regulations.

10 MS. GAVRILAS: Definitely.

11MR. TIKTINSKY: So that's always something 12 we want to make sure that, you know, why we close 13 meetings related to discussions of that and 14 information that's the integrated safety analysis or 15 things that are preferably security related.

16MR. BALAZIK: Anybody have anything else?

17MS. GAVRILAS: Open it to the public I 18 would say.

19MR. BALAZIK: All right, we can open up to 20the public. Actually, I do have one more item.

21Karen, you mentioned resources. Is there the 22 potential for any impact in the future for Northwest 23 resources for the review of this application, or even 24future applications? There would be no change or any 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 151 fluctuations that could potentially happen?

1MS. HAASS: Well, there's no change in our 2 primary subcontractors, no.

3 MR. BALAZIK: Okay.

4MS. HAASS: And they have the people to 5support this. But, you know, you still have to 6 schedule it.

7MR. BALAZIK: Yes, no. I understand, I 8 understand.

9MS. HAASS: So yes, but that is not going 10 to change.

11MR. LYNCH: I guess maybe just as a 12 closing question, do you feel like your expectations 13were met today? Did we accomplish what you wanted to 14 accomplish at this meeting, or at least start moving 15 in the right direction?

16 MR. FOWLER: So we had two objectives as 17we introduced this meeting from a Northwest Medical 18Isotopes perspective. The first was gaining alignment 19around or understanding in common of the licensing 20 application process.

21 And that one we've I think beaten to death 22 and are in violent agreement now with an understanding 23 from both NRC and from Northwest Medical Isotopes of 24 the options. And the follow up next step on that is 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 152to telegraph to the NRC our intentions. And so I 1 think from a first objective standpoint, we can 2 declare success on that one.

3 The second, and frankly more important one 4 to the nation and to public health and to public 5 safety is the speed with which we can accomplish a 6 successful review within the guidelines and 7 regulations.

8 I think this is, we did not have an 9 expectation that that would be solved in this meeting 10today. Our expectation was that we would have a plan 11 to get to a plan.

12 What we accomplished in my view today is 13 I've received more granularity in the schedule 14 elements from the NRC and the assumptions behind the 15 schedules, how many iterations of RAIs, how many 16 iterations for the RCS and so forth.

17 So I think we now have a framework with 18 which we can succeed in a productive conversation on 19 translating the list, Steve, that you've so well-20 articulated and added to and convert that into an 21 operating plan.

22 And ultimately, what it comes down to to 23a company like ours is predictability. Sufficient 24 granularity in schedules so we know what's next, how 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 153 do we assess that each one of those milestones whether 1 it's on track or off track, and our ability to predict 2 those next steps, manage accountability, manage 3 schedule, manage budgets.

4 The risk to any business, the biggest risk 5to any business is uncertainty. And we've been in an 6uncertain environment. And this meeting succeeded in 7 helping to remove some of the uncertainty in terms of 8 establishing a framework where we can now discuss the 9 schedule.10 And a number of the elements are going to 11obviously fall right back on us. We have better 12 expectations of what the standard is by which we need 13to meet. But I think we also can establish a program 14 management plan so we collectively understand when a 15 milestone's been achieved and what the next milestone 16 that we all need to focus on.

17MR. BALAZIK: And if there are no more, 18this is Mike Balazik, again. If there are no more 19 questions in the room, first of all I guess I would 20 like to ask if there's any NRC staff on the phone that 21 has any questions. And then we'll open it up to the 22 public.23 (No audible response) 24 MR. BALAZIK: Okay, hearing no questions 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 154 from the NRC staff, so now I would like to open up the 1phone lines to the public for public comment. Just a 2 couple of items.

3 Please, speak one at a time and identify 4yourself in speaking. And also if you're 5 uncomfortable asking a question on the phone, you can 6 submit your question to me via email at mfb@nrc.gov.

7 Are there any public comments?

8 (No audible response) 9MR. ADAMS: Can someone verify that the 10 phones are still open and working?

11 PARTICIPANT: Yes, the phones are open.

12MR. ADAMS: All right, we just want to 13 make sure silence wasn't something unplugged 14 somewhere.

15 MR. LYNCH: Thanks, Jenny.

16 PARTICIPANT: We're here, thank you.

17MR. BALAZIK: All right. So I think we 18 are, are we expecting Bill and others to join us 19 later?20MS. GAVRILAS: Yes. I think we'll adjourn 21 until 2:30 when we have an opportunity to interact 22with two office directors. I think at least one 23office director, perhaps two. And certainly my boss, 24 Lawrence Kokajko is going to join us.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 155 I don't know if Craig who is the acting 1 director in Shana's organization is also going to join 2us. So you'll have an opportunity to reiterate, we'll 3 reiterate our action items and you'll have an 4 opportunity to interact with them.

5MS. HAASS: And which office directors, 6 potentially?

7 MS. HELTON: Bill Dean.

8MS. GAVRILAS: Bill Dean, our director is 9 coming for sure.

10 MS. HAASS: Okay.

11 MS. GAVRILAS: And his deputy might come 12 as well.13 MR. ADAMS: So we're going to go mute on 14 the phones until 2:30 and then we'll be back on.

15 (Whereupon, the above-ent itled matter went 16 off the record at 1:54 p.m. and resumed at 2:33 p.m.)

17MR. BALAZIK: Mike Balazik, we're resuming 18the public meeting. Right now we're toward the end of 19the meeting. And we just want to real quickly go 20 through some closing remarks. Oh, I'm sorry.

21 Bill Dean, Office Director of NRR is 22 joining us, and Michele Evans has also joined us, and 23Lawrence Kokajko has also joined is. He's the 24Director of DPR, for our members on the phone. All 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 156 right.1 (Off microphone comments) 2MR. BALAZIK: Okay, can we just go through 3 everybody, identify themself that's new to the 4 meeting?5 (Simultaneous speaking) 6 MS. EVANS: Sure. Michele Evans, Deputy 7 Director of NRR.

8 MR. KOKAJKO: Lawrence Kokajko, Division 9 Director, Division of Policy and Rulemaking.

10MS. MARSHALL: Jane Marshall, Deputy 11 Director, Division of License Renewal, NRR.

12MR. ERLANGER: Craig Erlanger, Acting 13 Director for the Division of Fuel Cycle Safety 14 Safeguards and Environmental Review.

15 (Off microphone comments) 16 MR. BALAZIK: Okay. You want to start?

17MS. GAVRILAS: Yes, so we had what I would 18qualify as a productive meeting this morning. And I'm 19 going to ask the Northwest Medical Isotopes to bring 20 their own clarification.

21 Mike and Steve prepared a few summary 22 points of the meeting that I'll ask them to go 23through, a couple of action items. And then I know 24 that Bill would like to engage you in some 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 157discussions. And with that, I'm going to ask Mike to 1 summarize.

2MR. BALAZIK: You going to go through the 3 points, Steve? You have the points?

4 MR. LYNCH: Whatever you would like.

5 MR. BALAZIK: Yes.

6 MR. LYNCH: I can go through it.

7MS. GAVRILAS: One of you two needs to do 8 the summary of this morning, please, and the action 9 items. Thank you very much.

10MR. LYNCH: All right. So I guess for 11 everyone's benefit that's in here that was not here in 12the morning, we had two main objectives that we had 13 set out to accomplish as identified by Northwest, and 14 those were to talk about the licensing approach for 15the facility. And then the second item was to talk 16 about mechanisms to expedite the review of Northwest's 17 construction permit application.

18 For the first point, we reached agreement 19 and a shared understanding that there is additional 20 technical information that Northwest will need to 21 provide to meet the Part 70 requirements in 10 CFR.

22 Whether that's submitted as part of their 23 operating license or as a separate application is up 24to them, but we are in agreement that regardless of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 158 how the information is packaged, we understand on both 1 sides what technical information needs to be provided.

2 Is that correct?

3 And then the second point for mechanisms 4 to expedite the review, we went over a number of items 5 that we can do on both sides to make sure that we 6 review their construction permit application as 7 expeditiously as possible.

8 One of the items we discussed were 9 approaches to request for additional information to 10 limit both the total number of RAIs that we asked and 11 the number of rounds that we go through.

12 Ways that we can address that are ensuring 13 that the NRC is clear in the questions that we ask and 14 making sure that we have phone calls with Northwest 15 when those RAIs are issued to make sure they 16 understand the question that we are asking.

17 And also when they are getting prepared to 18 submit their responses, to have additional calls.

19 That may take the form of a public meeting if we need 20 to discuss technical details, or it could be shorter 21 clarification calls to make sure that they're on the 22 right track.

23 Again, the goal of that is to make sure 24 that we have a shared understanding of the NRC's 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 159 expectations and what Northwest's understanding of our 1 expectations is. We also emphasize that quality and 2 completion of those RAIs is important as well.

3 This fed into a larger discussion of 4 appropriate methods of communication during the review 5process. We have already established weekly calls 6 following the docketing of the application that Mike 7 and others as needed sit on with Carolyn once a week 8 to discuss the status of the review and then the other 9administrative details as necessary. And that's 10 consistent with our practices for other reviews 11 throughout the agency.

12MR. DEAN: So how long has that been going 13 on? For how long?

14 MR. LYNCH: Since January 12th.

15 MR. DEAN: Okay, all right.

16MR. LYNCH: So right after we concepted 17 the review and everyone got back from the holidays.

18 MR. DEAN: Okay.

19MR. LYNCH: We discussed the importance of 20 staying up to date on schedule, both from the NRC's 21 perspective as we're doing our review to make sure we 22 communicate how we're progressing towards milestones, 23 and also to get updates from Northwest on 24 anticipations of when, you know, if they have any 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 160 delays on the current application, responses through 1 RAIs, and just updates of when they anticipate 2 submitting future applications such as their operating 3 license application.

4 We discussed, as far as the information at 5 Northwest provides what's the threshold of what's 6 acceptable to the NRC, we went there already following 7 our formatting content that I had provided in NUREG 8 1537 and the ISG augmenting NUREG 1537.

9 And as far as the threshold that we set 10 for the information that we're doing our review, we 11 told them that when we do our review we use our 12 standard review plan that is publically available, and 13 that is the threshold we set for the information that 14 we are looking for in their application.

15 And to maximize the efficiency of our 16 review, the clearer it is to us that they have 17 addressed the acceptance criteria in the standard 18 review plan, the easier it is for the NRC to move 19 forward quickly.

20MR. DEAN: Both for the Part 50 and the 21 Part 70 aspects?

22MR. LYNCH: Yes, yes. We discussed the 23 guidance for both aspects that they can use.

24 MR. DEAN: Okay.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 161MR. LYNCH: We also talked about the 1 importance of reducing administrative time for 2 processing on the NRC side and also preparation of 3documents on Northwest's side. The goal is through 4 our talks to make sure that there isn't significant 5 debt time where either side is sitting, not doing 6 anything and just waiting.

7 And this feeds into general program and 8 project management on both sides and making sure that 9 we are identifying clear goals towards working towards 10 the identified milestones that we have in the project.

11 And the last thing that we went over, or 12 I shouldn't say last thing, I could think of two more 13things. Looking at past precedents, we have examples 14of reviews we have done in the past, most recently 15 with SHINE, there are transcripts available from ACRS 16 meetings that they can look through as we go through 17ACRS to help improve their preparation for those 18 meetings.19 Also, they can get a sense from looking at 20 these applications for what the NRC has found 21 acceptable in the past and types of RAIs we've asked 22 in the past and what types of responses we're looking 23 for and similarity of reviews.

24 As we get ready for their operating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 162 license application, one way we can get ready for that 1 is we explore the possibility of having pre-2 application meetings to discuss the technical problems 3 or issues that may come up that we need to explore 4 before the application is submitted that there may be 5 questions on.

6 And also with the current construction 7 permit application, we talked about efficiencies that 8 can be gained from maintaining that document up to 9 date as they respond to RAIs and information in their 10 current PSAR needs to be updated, that they can 11 provide updates to that.

12 At times it will work out with Mike, it 13 will make it easier for our reviewers to have a single 14 document to look at that has all of the updated and 15 completed information, and also as we go forward to 16 the ACRS and with the mandatory hearing.

17 We also discussed earlier today the status 18of our review and our plans going forward. So with 19 all of that, I think with that I think with those 20 topics, that addressed the second main point of 21 talking about ways that we could expedite the review.

22 I think that covers it for that second point.

23MR. FOWLER: You did a good job, thank 24 you.25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 163MR. LYNCH: And then between 1:30 and 2:00 1 we came up with a list of action items to take away to 2 come back to in the future. The first of these was 3 setting up a, exploring the possibility of setting up 4 standing public meetings.

5 And this, Mike and Northwest will work 6together on this to see if it's needed. But the idea 7 behind this is to cut down on some of that 8 administrative time.

9 If we see the need to discuss significant 10 technical information, most likely related to RAIs on 11 a regular basis, instead of noticing public meetings 12 every time we need to have one, we set up a frequency 13 maybe once a month, once every other month, something 14that's agreed upon between both parties. That was 15 identified as a topic worth exploring in the future to 16 see if it could help in the review.

17 The next action item we had was in a 18 future meeting discuss when the final design for 19Northwest will be provided to the NRC. This includes, 20 you know, the final design could be submitted as part 21 of the operating license application, or it could be 22 submitted while we are still reviewing the 23 construction permit.

24 And understanding Northwest's intent will 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 164help us in our preparations. And then on our side of 1that, we can discuss with them in the future the 2 impact of their decision to go forward one way or 3 another, without recommending a preference.

4 The third item that I had here was the NRC 5 could benefit also from understanding any additional 6 licensing actions that Northwest may request in the 7 future.8 This could be related to transportation of 9 materials, any exemptions that they foresee needing 10 for their current licensing requests or future 11licensing requests. Also, license amendments that 12 existing research reactors might need in order to 13 support the radiations of their manufacture targets.

14 Fourth item that we had as a take-away was 15 making sure that we have clear expectations on both 16sides. This has to do with, mostly with requests for 17 additional information.

18 Northwest would like to be able to review 19 drafts of the RAIs for potential proprietary 20information before they're issued. And also to the 21 extent practicable, we would like notifications of 22 when the RAIs are getting close to being issued so 23 that they can make sure that their resources are ready 24 to receive any begin working on responses to them.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 165 Also, Northwest offered that for future 1 public meetings, that we have it out in Missouri, that 2 the local government there is willing to work with us 3 in getting that set up in the future as well.

4 And I think the last thing, the last 5 action item I had on here was on both sides, and it's 6 kind of relates to everything else we've just been 7 talking about is just having clear communications on 8 both sides of schedule, NRC making sure that we 9 identify the milestones that we're working towards and 10 our progress towards that and Northwest, again letting 11 us know their schedule and any impacts they may have.

12 MR. DEAN: Okay, is that it?

13 MR. LYNCH: Yes.

14 MR. DEAN: Okay. Good. Sounds like you 15guys had a productive meeting. So appreciate you guys 16 coming here from Oregon? Both of you from Oregon?

17 MS. HAASS: The northwest.

18MR. DEAN: Northwest? Okay. Go Ducks.

19 No?20MR. FOWLER: Well, we have Ducks and 21 Beavers.22MR. DEAN: Okay, all right. Depends what 23 part.24 MS. HAASS: I'm a Husky.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 166 MR. DEAN: Okay, depends on what part of 1the state that you're from. Well, so I appreciate you 2guys coming in. And it sounds like it was very 3 productive and useful meeting.

4 I know that you all were here not too long 5 ago and had expressed some concerns with some of our 6 commissioners and some of our senior management about 7 the process and not having a good understanding of the 8 process.9 And so it sounds like, and I certainly 10 would be interested in your all's perspective that 11 today's meeting helped move us forward in terms of 12 establishing better communication and better 13 understanding of what you can expect from us, but also 14 things that we hope that we can engender from your 15 side of it because I view, personally I view this 16 process, and it's a big deal right, moly-99 is a big 17 deal for this country.

18 And so you guys are pursuing something 19 that is important to public health and safety which is 20 obviously the ultimate mission or objective of the 21 NRC, that we do it in a collaborative way and not in 22 any sort of adversarial way.

23 I know there's always just sort of dynamic 24 in terms of a licensee or an applicant and the NRC and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 167 we ask a bunch of questions, you got to give us a 1 bunch of answers.

2 But in reality, I think we're all striving 3 to get to the same point which is can we get licensed 4 for construction and utilization a facility that can 5 be useful in providing moly-99.

6 So in that regard, I think what we have is 7a very common end point. So I guess I would be 8 interested in your all's perspective in terms of how 9 you thought today's discussion went, were we able to 10 address perhaps some of the concerns you've had in the 11 past.12 And if there's still some open questions, 13 you know, Steve went through a list of action items, 14 but are there still some things that you all have in 15 your mind that are kind of open or areas that we ought 16 to consider.

17 Like, one thing I didn't hear in your 18 discussion was the benefit of, you know, sometimes 19 when we get an RAI process there's this kind of 20 throwing stuff over the transom and then you all 21 develop and throw it back over the transom.

22 And sometimes we can make better progress 23 if we do things like, well we call them audits, right, 24 but we actually either send people to wherever the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 168 information is and have face to face meetings as 1 opposed to going into a sort of a writing campaign.

2 Is that something you guys talked about was the audit 3 process?4MR. LYNCH: We did not talk about that 5today. But we have had an audit on the environmental 6 side as they were preparing information.

7 MR. DEAN: Okay.

8MR. LYNCH: So we have gone through that.

9MS. HAASS: And we've had the discussions 10 in the past and we know that it's one of the tools we 11 can use to make things more efficient.

12 MR. DEAN: Okay. Okay, good. Okay, and 13 then the other one was I didn't hear anything about 14 would it be beneficial for example to set up an 15 electronic reading room where you guys have materials 16 that you developed that are accessible to our staff 17 through some sort of portal or whatever so there's 18 more ready actions instead of you guys having to mail 19 them.20MS. HAASS: Well, and we are setting that 21up. There's always technical difficulties because you 22 guys have some requirements and you know what they 23 are, you know, about the encryption and the passwords 24and this, that, and the other. And so those things 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 169 are getting set up.

1 MR. DEAN: Okay. I think we've had some 2 success where the licensee sort of maintains that and 3 then we just get a password for access and it helps 4 maybe avoid some of those, you know, red tape things 5 that we tend to have as a bureaucracy.

6 But anyway, so we certainly, that would be 7 something that could hopefully improve or increase 8 efficiency.

9 MS. HAASS: Well, and another thing that 10 could help efficiencies is I know we talked about it 11a bit offline just standing here. But, you know, some 12 granularity on how, what RAIs are going to be coming 13 because you're not going to throw all of them over at 14 once.15You may be doing them based on subject 16 matter areas and, you know, getting a better 17 granularity in a schedule like that because that helps 18 both your resources and ours and us to be more 19 efficient in responding as well.

20 MR. DEAN: So I was pleased to hear that 21you guys have set up weekly calls. So hopefully 22you're finding those beneficial. I know that we do in 23 terms of being able to ferret out those sort of 24 things.25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 170 And I don't know whether, have you guys 1 kind of developed sort of a standing agenda, or has it 2 kind of been sort of ad hoc? I would assume that 3 there's things that week to week that you're going to 4 want to talk about.

5MS. HAASS: Yes, there's definitely a 6standing agenda. But then, you know, you've got 7 things come on and off that agenda as well.

8MR. BALAZIK: And this is Mike Balazik.

9 And sometimes we'll share stuff earlier in the week 10 that is to be a great topic to have on that weekly 11 call so that we can take one level deeper into it if 12 it's just Kevin and I talking. Sometimes we'll move 13 stuff on a weekly call.

14MR. DEAN: And also to make sure we get 15 the right people there.

16 MR. BALAZIK: Correct.

17MR. DEAN: Okay, all right. So that's 18 good. I think that's a great initiative to do that.

19 So at least what I'm hearing was that it was a 20 constructive, worthwhile meeting, is that --

21MR. FOWLER: I do believe it was a very 22productive meeting. And for those of you who attended 23 our meeting about a month ago in the Executive 24 Director's office, we understand that the NRC has a 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 171 mission for public health and takes the production 1 capability this country for moly-99 very seriously.

2 We understand that, appreciate that, 3respect that. I hope that you all also understand 4 that we take our mission of providing that secure, 5 reliable supply of moly-99 in the United States 6extremely seriously. That was part of the intent with 7 the Executive Director's office when we were there.

8 We also wanted to communicate that while 9 we all know that this is a public health potential 10 issue, sometimes hearing directly from the feet on the 11 street, the constituents and our supporters and 12 investors are public healthcare institutions serving 13 tens of millions of people across the United States.

14 And so to hear directly from the CEOs of 15 those public health services organizations I think is 16 important to remind us of just how real the mission 17that we share collaboratively really is. It's 18 extremely important.

19 This meeting stemmed as a follow up to a 20 couple of outstanding items from the initial meeting, 21 the first being clarification on our licensing 22application submission process. And that one, declare 23 victory.24We understand it is in good shape. We 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 172 all, I think, are in agreement that we understand 1where to go from here. We will need to telegraph our 2approach so that the NRC can anticipate. But we're 3 all on common understanding of that first objective.

4 So declare success on that one.

5 The much broader one is how do we meet the 6 needs of this country in a timely fashion. And what 7 we achieved today was establishment of a very strong 8 framework that we now understand better how the 9 schedule of review is constructed and built within the 10 NRC.11 That helps tremendously because we can 12 look at the assumptions, we can compare the 13 assumptions, and we can begin to manage this as a 14project. It's likely, in fact it's assured, that 15 we'll need a number of follow up conversations to 16 translate that framework into a plan that can be 17 project managed, and we've left with a joint objective 18 to do exactly that.

19 And Steve did a great job of summarizing 20some of those actions. And so we can't yet close with 21 full success the second objective on accelerate the 22 schedule to degree possible.

23 I think we have a pathway to continue a 24 process to get to a mutually agreed schedule, one that 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 173we can both bring back to our supporters and manage 1 against with expectations, identify milestones, 2 identify where we've deviated from milestones, and 3 take remedial actions as appropriate.

4 And that, to me, is a successful day spent 5 here in the DC area.

6MR. DEAN: Well good, I'm pleased to hear 7that, Nick, in terms of your perspective on how the 8 meeting went because certainly this was one that I 9 felt was very important, you know, the fact that 10 Michele and I and Lawrence wanted to make sure that we 11 touched base with you all before you left to make sure 12 that the meeting met your objective was very important 13 to us.14 And so that gives me great confidence that 15 we did have a constructive and productive dialogue.

16 But we need to sustain that.

17 MR. FOWLER: Exactly right.

18 MR. DEAN: And I like some of the things 19 you guys have talked about in terms of potential 20 action items. I was interested a little bit more in 21 exploring the topic that Steve raised that when we 22 have meetings in Missouri and the engagement of the 23 local government.

24 What's the sort of the rationale, what are 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 174we trying to achieve with that. That's a good thing, 1 but I mean --

2MR. FOWLER: That was in specific 3 reference to any ongoing environmental public meeting 4 needs where we've had one meeting in Columbia already.

5 If there were needs for others, the City of Columbia 6 and the County of Boone County in Missouri have 7 offered any and all assistance to the NRC if any is 8 requested.

9 MR. DEAN: Okay.

10 MR. FOWLER: They stand ready to help.

11 MR. DEAN: Okay.

12MR. LYNCH: And this is consistent with 13 previous reviews, even for the SHINE review we've gone 14 out for the environmental meetings generally, send an 15 email to the city manager and county executives, let 16 them know we're coming, offer any government-17 government interaction they would like to better 18 understand our process and work our way forward.

19 MR. DEAN: Okay.

20 MR. LYNCH: So that's all consistent.

21 MR. DEAN: Okay. Good, okay. Good.

22 MS. HAASS: And there's also the ability 23 that they would help you coordinate to make things 24easier, you know, on you. They have the facilities 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 175 available.

1 MR. DEAN: That's great.

2MS. HAASS: And so, and they want to be 3 involved.4MR. DEAN: Super. Okay, that's wonderful.

5Okay, good. Okay. Anything for me that you would 6 like to convey beyond what you already have?

7MR. FOWLER: Well I think that again, 8we've had a successful meeting. I think in other 9 strategic partnerships that are collaborative in 10 business that I run, we have not only program 11 management at the level of checking all the boxes on 12 the program plan, we have a refreshment at this level 13 to ensure that both parties are in fact comfortable 14 with progress and resource assignments and strategic 15 alignment as we move forward.

16 Certainly it doesn't need to be a monthly 17 meeting at this level, but probably on a quarterly or 18 semi-annual basis it would make sense for us to touch 19 base at this level to ensure that we're both meeting 20 each other's expectations of moving forward.

21 MR. DEAN: Okay. And you're comfortable 22 with the 12 to 15 to 1 ratio of members of the NRC?

23 Is that okay? You're comfortable with that ratio?

24MR. FOWLER: Well, come out our way and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 176 we'll reverse the ratio.

1MR. DEAN: Good, good. Well, anything 2 else that you would like to achieve today?

3 MS. GAVRILAS: No. I think we met their 4 objectives and we have a good meeting.

5MR. DEAN: Okay, good. Good. All right, 6 so who do I point to in terms of is it Mike is the 7 sort of individual that I want to point to as 8somebody, for SHINE I went to Steve a lot. So is 9 Mike?10MS. GAVRILAS: So that was one of the 11 issues we discussed that even though there are 12 multiple organizations involved in the review, there 13 will be one voice for the NRC and that voice is Mike.

14MR. DEAN: Okay, good. Okay, good.

15 Super. Okay, anything else? Excellent. Okay.

16MR. FOWLER: Finished the agenda on time.

17MR. DEAN: Safe travels. Safe travels 18 back.19MR. BALAZIK: This is Mike Balazik. I 20 just want to thank everybody for attending the meeting 21today. And we're going to close the bridge line.

22 Thank you.

23 (Whereupon, the meeting in the above-24 entitled matter was concluded at 2:58 p.m.)

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Meeting with Northwest Medical Isotopes Doc ket Number:Location:Rockville, Maryland Date:Thursday, February 18, 2016Work 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 UNITED STATES OF AMERICA 1 NUCLEAR REGULATORY COMMISSION 2+ + + + +3 PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC 4+ + + + +5 THURSDAY, 6 FEBRUARY 18, 2016 7+ + + + +8 ROCKVILLE, MARYLAND 9+ + + + +10 The Public Meeting commenced in Room O-11 16B4, One White Flint North, 11555 Rockville Pike, at 12 8:30 a.m., Mike Balazik, Project Manager, presiding.

13 14 NRC STAFF PRESENT:

15 LAWRENCE KOKAJKO, Director, Division of Policy and 16 Rulemaking, Office of Nuclear Reactor 17 Regulation 18 WILLIAM DEAN, Regional Administrator, Region I 19 CRAIG ERLANGER, Acting Director, Division of Fuel 20 Cycle Safety, Safeguards, & Environmental 21 Review, Office of Nuclear Material Safety and 22 Safeguards 23 MICHELE EVANS, Deputy Director, Office of Nuclear 24 Reactor Regulation 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 2 JANE MARSHALL, Deputy Director, Division of License 1 Renewal, Office of Nuclear Reactor Regulation 2 MICHAEL BALAZIK, Project Manager, Division of Policy 3 and Rulemaking, Office of Nuclear Reactor 4 Regulation 5 ALEXANDER ADAMS, Chief, Research and Test Reactors 6 Licensing, Office of Nuclear Reactor 7 Regulation 8 MIRELA GAVRILAS, Deputy Director, Division of Policy 9 and Rulemaking, Office of Nuclear Reactor 10 Regulation 11 SHANA HELTON, Acting Deputy Division Director, 12 Division of Fuel Cycle Safety, Safeguards &

13 Environmental Review, Office of Nuclear 14 Material Safety and Safeguards 15 ROBERT JOHNSON, Chief, Fuel Manufacturing Branch, 16 Office of Nuclear Material Safety and 17 Safeguards 18 STEVE LYNCH, Project Manager, Research and Test 19 Reactors Licensing Branch, Office of Nuclear 20 Reactor Regulation 21 NANCY MARTINEZ, Environmental Project Manager, 22 Office of Nuclear Reactor Regulation 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 3 DAVE TIKTINSKY, Project Manager, Fuel Manufacturing 1 Branch, Office of Nuclear Material Safety and 2 Safeguards 3 4 ALSO PRESENT:

5 NICHOLAS FOWLER, Chief Executive Officer, NWMI 6 CAROLYN HAASS, Chief Operating Officer, NWMI 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 4 T-A-B-L-E O-F C-O-N-T-E-N-T-S 1 Page 2 Opening Remarks by NRC Staff 3 Michael Balazik..............6 4 Mirela Gavrilas..............13 5 Shana Helton...............14 6 Opening Remarks by Northwest Medical Isotopes 7 Nicholas Fowler..............15 8 NRC Licensing Processes 9 10 CFR Part 50, General 10 Steve Lynch................20 11 10 CFR Part 51, Environmental 12 Nancy Martinez..............36 13 10 CFR Part 50, Construction & Operating License 14 Steve Lynch................42 15 NRC Licensing Process, Part 70 16 Dave Tiktinsky..............90 17 Licensing Review Request (NWMI licensing request and 18 NRC understanding of request - NRC/NWMI) 19 Al Adams................113 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 5 Communications (NRC/NWMI) 1 Michael Balazik.............126 2 Steve Lynch...............130 3 Al Adams................134 4 Dave Tiktinsky.............135 5 NWMI Topics for Discussion..........141 6 Closing Remarks/Summary............155 7 Adjourned...................176 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 6 P-R-O-C-E-E-D-I-N-G-S 1 (8:33 a.m.)

2MR. BALAZIK: All right, good morning.

3I'd like welcome everyone in attendance today. My 4name is Mike Balazik. I'm a project manager in the 5 Division of Policy and Rulemaking at the NRC.

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

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

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

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

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

24 There's a sign-in sheet that may be moving around the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 7 room right now. I ask everyone sign in. Yes, thank 1 you.2 If you wish to provide any comments on the 3 meeting, I can provide you a meeting feedback form.

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

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

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

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

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

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

24 Before we begin, a couple of items I'd 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 8like to mention. First of all, please limit 1interruptions. Silence your cell phone and please 2 keep side conversations to a minimum.

3I ask you speak one at a time. And 4individuals on the phone, please mute your phone 5 unless you're going to provide any comment.

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

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

10 Next I'd like to remind you that you're 11within a NRC controlled space. Should there be an 12 emergency all occupants should begin to calmly 13evacuate using the nearest stairwell to exit the 14 building.15 All visitors will be escorted by the NRC 16staff. Disables persons, who due to health reasons 17 feel they cannot safety walk down the stairs to 18evacuate, may use the elevators. Exit through the 19 nearest door and then go to the pause area in front of 20 One White Flint and report their presence with the 21 guard.22 So you experience, observe anyone with a 23 life threatening medical complaint while evacuating, 24call 911 and report your location and nature of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 9 emergency.

1Also, if you need to use the restroom, 2 you'll need to be escorted.

3All right. So let's now run though 4introductions. I'd ask everyone to speak loudly so 5people on the phone can here you. And let's start 6 around the table.

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

10MS. MARTINEZ: Good morning. I'm Nancy 11 Martinez, NRC Environmental Project Manager.

12MS. GAVRILAS: Mirela Gavrilas, Deputy 13 Director, Division of Policy and Rulemaking in NRR at 14 the NRC.15MR. LYNCH: This is Steve Lynch. I'm a 16 Project Manager with Research and Test Reactors.

17 And real quick, before we go on with the 18 introductions, if you are participating on the phone, 19could you please put your phone on mute? We're 20getting a lot of feedback in the room here. Thank 21 you.22MR. ADAMS: Al Adams, Chief of Research 23 and Test Reactor Licensing, NRC.

24MR. TIKTINSKY: Dave Tiktinsky, Project 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 10 Manager of the Field Manufacturing Branch in Office of 1 Nuclear Material Safety and Safeguards.

2MR. JOHNSON: Good morning. Robert 3 Johnson, Fuel Manufacturing Branch Chief, NMSS.

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

6MR. FOWLER: Nick Fowler, the Chief 7 Executive Officer of Northwest Medical Isotopes.

8MS. HAASS: Carolyn Haass, Chief Operating 9 Office, Northwest Medical Isotopes.

10MS. KEIM: Andrea Keim, Vendor Inspection 11 and Quality Assurance, NRR.

12MR. MATULA: Tom Matula, NMSS, Project 13 Manager.14MR. MORRISSEY: Kevin Morrissey, Fuel 15 Cycle Review.

16MS. ADAMS: Mary Adams, Fuel Cycle Safety 17 and Environmental Review.

18MS. LONDON: Lisa London, Office of 19 General Counsel.

20MS. BIELECKI: Jessica Bielecki, Office of 21 General Counsel.

22MR. LINDELL: Joseph Lindell, Office of 23 General Counsel.

24MS. KANATAS: Catherine Kanatas, Office of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 11 General Counsel.

1MS. YOUNG: Mitzi Young, Office of the 2 General Counsel.

3MS. TRAN: Linh Tran, Research and Test 4 Reactor Licensing Branch, NRC.

5MR. ALLEN: Eben Allen, Research and Test 6 Reactor, Project Manager.

7MR. BALAZIK: This is Mike Balazik, please 8mute your phones. Somebody's got an open line and 9 they're speaking and we're hearing you in the room.

10 MR. LYNCH: Star 6.

11MR. DANNA: Jim Danna, NRR, Division of 12 License Renewal.

13MR. MILLER: Chris Miller, Office of 14 Nuclear Reactor Regulation. And I'm the Director of 15 the Division of License Group.

16MR. ISAAC: Patrick Isaac, Research 17 Reactor Oversight Branch.

18MR. BALAZIK: All right, this is Mike 19Balazik again. Let's go to the phone line. I ask 20 individuals to identify themselves.

21MR. RODRIGUEZ: Michael Rodriguez, NRC, 22 NSIR EP.23 MR. FLAGG: Michael Flagg, University of 24 Missouri Research Reactor.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 12 MS. MCCULLOUGH: Kara McCullough, NSIR, 1 NRLB.2 MR. BERICK: Dave Berick with Senator Ron 3 W.4 MS. RIVERA: Alison Rivera, NSIR EP.

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

7 MS. WEIL: Jenny Weil, Congressional 8 Affairs.9 MS. FRAZIER: Andy Frazier, Region III 10 Office.11 MS. MOSER: Michelle Moser, Environmental 12 Energy Staff.

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

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

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

19 MR. FOLK: Kevin Folk, NRC Environmental 20 Staff.21 MR. WEBER: Carl Weber, NRC, Office of New 22 Reactors.23 MR. BALAZIK: Is there anybody else on the 24 phone that wishes to identify themselves? Okay, I'm 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 13 hearing none.

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

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

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

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

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

22 So our main objective today is basically 23 to discuss the topics that we agreed with Northwest 24Medical, should be discussed today. And we want to 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 14have open dialogue. So please ask questions at any 1 time.2 Again, we have the technical and the 3 regulatory experts in the room to address your 4questions. So we want to make sure that at the end of 5 the meeting, we're aligned in terms of our 6 understanding of where we are in terms of the review 7 of the construction permit that's in front of us now, 8 as well we the preview of the operating license that 9 is still to come.

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

13MS. HELTON: Thanks, Mirela. I agree with 14Mirela's points. I can't emphasize enough the need to 15 obtain clarity on both sides, so that we can have an 16 efficient, effective licensing path forward.

17 And to that end, I just want to say, that 18 while multiple offices are involved with this review, 19we do act as one NRC. You will hear from us with one 20 voice.21 Mike Balazik will be your primary point of 22 contact. So you don't have to worry about trying to 23 correlate between different offices.

24 And just as we go through this, one point 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 15 that I wanted to emphasize is that for each 1 application that we receive as an Agency, not just in 2 this area of medical isotopes, we review each 3 application based on its merits.

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

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

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

16MR. BALAZIK: This is Mike Balazik. Thank 17you, Shana.

Now I'll turn it over to Northwest 18 Medical Isotopes for some opening remarks.

19MR. FOWLER: Well, and I would add my 20thanks to everyone that's assembled here. In that we 21all understand the importance of serving a reliable 22 and secure supply within the United States for moly-23 99.24 And we met with the executive director and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 16 his direct staff and a number of folks who are in this 1 room a month ago. And we believe, Northwest Medical 2 Isotopes believe, it was an excellent conversation.

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

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

9And we all recognize the need for this 10reliable supply of moly in the United States. But 11 sometimes hearing it from a healthcare services 12 provider that's responsible for millions of people, 13 who can provide that direct testimony of what it means 14when there are shortages, is important. And we 15 thought that important to provide that direct 16 perspective into the executive meeting a month ago.

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

23 We then had a fruitful discussion on two 24 questions that Northwest Medical Isotopes had 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 17specifically. And we hope that this meeting today 1 directly addresses those two questions as follow up to 2 that meeting.

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

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

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

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

23 And in the interest of everybody's time 24 assembled, I think the package is great from an 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 18educational standpoint. I think we understand largely 1 the background.

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

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

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

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

15MR. BALAZIK: Thank you, Nicholas, I 16 appreciate that.

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 19 What we're trying to understand is, not 1 just what your questions are, but why you asked those 2questions. Because we want to make sure that we're 3 answering, not just the words, but the intent of what 4 you're trying to find out.

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

10MR. BALAZIK: All right, this is Mike 11Balazik again. First of all, for transcription 12 purposes, please identify yourself prior to speaking.

13 And let's start the presentation.

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

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

23 Basically this is the meeting purpose.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 20 Just provide a general overview of the NRC, oops, I'm 1 sorry. It skipped one on me.

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

8 Okay?9 And next we'll go into the licensing.

10MR. LYNCH: Sure. This is Steve Lynch.

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

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

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

20 Is we've done something before, hopefully the next 21 time we do it we can apply the lessons learned from 22 before.23 So to get started with this introduction 24 here, these considerations are for both the applicant 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 21 and the NRC. We want to emphasis that where we pick 1 the licensing process from the regulations is driven 2 by the technology that's put in front of us.

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

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

10Are you going to be making targets, are 11 you going to be irradiating targets, will you be 12processing targets. How will you be irradiating your 13 targets. Will you be using a nuclear reactor. Will 14 an accelerator be involved.

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

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

23 And then one of the other considerations 24 we look at is, will you be using new or existing 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 22facilities. And as I understand with Northwest, it 1will be a mixture of both. Using existing research 2 reactors as well as constructing a new facility for 3 processing.

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

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

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

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

20Next slide. So we're going to spend today 21 highlighting some of the different processes that we 22use from that previous slide. Especially focusing on 23 Part 50, for the production facility, Part 70, for 24material. And then also Part 51 for the environmental 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 23 review process.

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

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

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

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

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

24 Another main component of the operating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 24 license application will be the Physical Security 1 Plan.2 Our commitment to doing these reviews, for 3 both the construction permit and the operating 4 license, is to finish these reviews within a year and 5 a half to two years from docketing the application.

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

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

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

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

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

24 That's Section 103.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 25 And as I'm sure you're aware, this is 1slightly different than most of the other non-power 2 facilities that we license under Part 50. Those are 3 generally research reactors that are non-commercial 4 facilities.

5 And the main difference that we see there 6 is that there will be a mandatory hearing on your 7 application. And there will be a review by the ACRS 8 as well.9 The other, some of the other things that 10 you're aware of under 50.30, you're to submit an 11environmental report, which you have done. And submit 12 a preliminary safety analysis report under 50.34, also 13 what you have done.

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

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

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

24 50.35, which I'll go into more detail on on the next 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 26 slide, as far as the findings that the commission 1 needs to make in order to issue a construction permit.

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

4Next slide. So as the NRC evaluates your 5 application, these are the primary four findings that 6 we are looking to make, based on the information that 7 you have provided.

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

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

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

16And that you are left to propose your own design 17 criteria per your facility in this case.

18 We also recognize that we are being 19provided a preliminary design. And as such, there may 20 be information that you have not provided at this 21 time.22 We're looking to make the conclusion that 23 the information you have chosen to provide at a later 24 date is acceptable, but we don't need it at this time 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 27 in order to establish a preliminary design.

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

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

13Next slide. So this slide, what I wanted 14 to emphasize is the difference between the 15 determinations that we're making at the construction 16 stage and at the operating license stage.

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

21 In contrast, when we issue an operating 22 license, this is when we say that, based on the final 23 design of the facility, that we believe it can be 24operated safety. So I just wanted to emphasize the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 28 difference in the emphasis that we place in those two 1 determinations.

2Next slide. So I'm hoping this slide 3 helps partially answer one of your questions that you 4 had about the l icensing process and how we look at 5your applications and how you can submit them. And 6 we'll go into some more detail on this when we get 7 specific with your application.

8But both the Atomic Energy Act and the 9 regulations allow for an applicant to combine 10 applications. And this is common.

11 There's, and mostly we'll see this with 12the operating license application. In order for 13 reactors to operate, they will also require a Part 70 14 license in order to possess and use material on their 15 site.16 And then following that up, the commission 17does combine those licenses. So you see, and Al will 18 show you an example of that later today.

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

24 So we are --

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 29MR. FOWLER: Can I ask a question at this 1 point?2 MR. LYNCH: Yes.

3MR. FOWLER: At the executive director 4meeting, Mirela, I believe you did a, at least you 5 helped me, and I'll use the, I could use inappropriate 6 terms in the regulatory environment because it's not 7 an environment that I deal with every day, but I 8 understood from your presentation, in that meeting, 9that we had the choice. That we could submit a 10 separate Part 70 license or we could submit, under the 11 Part 50 umbrella, the Part 70 requirements with the 12 important caveat that the Part 70 information, at that 13 point of submission, needed to be final because it was 14 a one-step process.

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

22MS. GAVRILAS: What I said at the meeting 23is still what our position is. And we'll walk you 24 through the slides.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 30This just helps explain the details. The 1 bottom line is, we look at your activities from a 2 safety perspective. And the security perspective.

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

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

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

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

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

23 If the activity was described on one piece of paper, 24you get credit for it. You don't need to describe it 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 31 again.1MS. HELTON: Mirela, I agree. I just want 2 to make sure that it's clear that the packaging is up 3to you. How you package it all together, multi 4 submissions, a single submission.

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

10 So it just has, however you do your 11 packaging, it has to be very clear that if you intend 12 for this information to satisfy Part 70, subpart (h), 13 or whatever you're going to do, that you have to very 14 explicitly.

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

21MS. GAVRILAS: And to add to what Shana is 22 saying, you can cross reference in all of your 23 document that you submitted.

24 MS. HELTON: Right.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 32 MS. GAVRILAS: And right away, that adds 1 to the case that I'm trying to make in this piece of 2 paper.3MR. FOWLER: So very simplistically, from 4 my standpoint, again, because I'm not schooled in the 5 art of regulatory review, is the final Part 70 6 information, we can include, either in our operating 7 license under Part 50 application or as a separate 8 Part 70 document, but we need to be clear about what 9 we're submitting under which format.

10 MS. HELTON: Right.

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

17MR. LYNCH: Yes. And I think what's most 18 important there is, we're looking to make our safety 19 determination based on technical information that you 20 provide.21 Whether it's Part 50 or Part 70, we still 22 have to say, we have technical requirements that we're 23trying to make to justify safety. So we're looking 24 for technical information.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 33 And when we have all that technical 1 information, we can figure out which box, you know, 2 will it be a full, will it be Part 50 with Part 70 as 3part of that or separately. But we will evaluate that 4 based on the request that you ask of us.

5MS. HAAS: We understand the safety 6aspect. I mean Nick is just trying to bring it up --

7 MR. FOWLER: Yes.

8MS. HAAS: --

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

11 So we just wanted to make sure that we understood it, 12and we do. So thank you for the input and we'll move 13 on.14MS. GAVRILAS: You know, we start every 15 public meeting with a disclaimer, which is, we're not 16 going to reach regulatory decisions here and there's 17 a reason for that.

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

21 So we have dialogue here. So right now, 22 what we have for review in front of us and what we can 23 be very specific on, at least the portions that we've 24reviewed, is the construction permit. The Part 50 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 34 construction permit.

1 Anything else is in pre-application space.

2 If that makes sense?

3 So if there is

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

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

10MR. LYNCH: Okay. Next slide. So what 11 we're going to transition to now is talking a little 12 bit more about the actual review process for the 13construction permit. And we'll get into timelines and 14 what our expectations are for the review that we have 15 ahead of us.

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

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

23 The results of each of these reviews will 24 feed into a number of things that will lead ultimately 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 35 to the commission's decision to either grant or deny 1 your request for a permit.

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

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

8 There's also a possibility that there 9 could be contentions filed as a result of this. And 10 we'll talk a little bit more about that in a few 11 slides, but that's another step that could be in this 12 process.13 The environmental review will also be, the 14 environmental impact statement that's being prepared, 15 will also be considered by the commission and its 16 decision to grant or deny the construction permit.

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

23MS. MARTINEZ: Thank you, Steve. As Steve 24 mentioned, I'm the environmental project manager for 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 36the application. And I'm going to discuss the 1 environmental review process.

2 The environmental review is going to be 3 performed in accordance with the National 4 Environmental Policy Act of 1969. Commonly known as 5 NEPA.6 NEPA requires fellow agencies to follow a 7 systematic approach in evaluating the potential 8 environmental impacts of the proposed action and to 9assess the alternatives to those actions. The NEPA 10 process involves public participation and disclosure.

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

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

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

21 If the application is accepted, the NRC 22staff conducts a NEPA document determination. And 23 that is to whether develop and prepare an 24 environmental assessment or an environmental impact 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 37 statement.

1 I will discuss in later slides, for the 2 Northwest application, the staff determined to prepare 3an environmental impact statement. Once the NEPA 4 determination is made, the environmental review 5 process is conducted in accordance with 10 CFR Part 6 51.7 Slide 18 please. This slide presents an 8 overview for NRC's environmental process.

9 Specifically for the environmental impact statement.

10 The environment review for an EIS begins 11with the scoping process. Which includes a public 12 meeting.13Scoping is a process by which the NRC 14 staff identifies a specific impact and significant 15 issues to be considered in preparation of the 16 environmental impact statement.

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

22 The draft EIS is issued for public 23comment. Once comments are received on the draft, the 24 NRC staff will consider those comments and issue its 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 38 final environmental impact statement.

1Slide 19 please. The environmental review 2 for the environmental impact statement will take 18 to 3 22 months. This slide provides a detailed breakdown 4 of the process and timeframes.

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

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

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

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

24 Information from the applicant's report, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 39 RAI responses, the scoping process, coordination with 1 other federal, state, tribal and local agencies, as 2 well as the staff's independent research, will be used 3 to draft the EIS.

4 When the draft EIS is published, it will 5 be made publically available for review and comment 6 for a 45 day period, in accordance with our 7regulations. The comment period will include a public 8 meeting.9 After the draft EIS comment period, the 10 staff will respond to comments provided on the draft 11EIS and update the EIS as necessary. And this can 12take approximately 120 to 150 days. And depends on 13 the number of comments and also the necessary EIS 14 updates. The final EIS is then issued.

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

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

23 The NRC staff conducted an acceptance 24 review of the Northwest environment report, Chapter 19 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 40 of the application, in accordance with 10 CFR Part 51, 1 which identifies the information that shall be 2 contained in the applicant's environmental report.

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

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

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

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

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

23Slide 23 please. The environmental review 24 will consider the impacts of construction, operation 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 41and decommissioning of the Northwest facility. We 1 will also consider the impacts of alternatives to the 2 proposed action, including alternative sites, 3 alternative technologies and the impacts of not 4 issuing a construction permit.

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

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

16Slide 24. The Northwest environmental 17scoping period ended January 4th, 2016. The staff is 18 currently developing the scoping summary report and 19 responding to comments.

20Two rounds of RAIs have been issued. The 21 first on November 2nd. Northwest responded to those 22RAIs on December 3rd. The staff reviewed the 23 responses and had some follow ups. And those RAIs 24 were issued on January 19.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 42 NRC anticipates that the draft EIS will be 1 issued on October 2016 and that the final EIS will be 2issued on May 2017. And this is based on the 3 timeframes in the slide that I have provided earlier.

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

5 And that concludes my presentation on 6 environmental review.

7MR. LYNCH: All right, next slide please.

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

9And I'm going to talk a little bit about the 10 construction permit safety review process.

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

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

23 While you're not required to submit 24 technical specifications at this time, we are looking 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 43 for the application to identify probable subjects of 1 technical specifications.

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

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

8Next slide please. So for the review that 9 we do, so the last slide talked about the regulatory 10requirements that need to be met. We had developed 11 guidance in order to evaluate whether those 12 requirements have been met.

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

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

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

21Other guidance that we used. There are 22 ANSI standards that are referenced in these documents 23 we used for our reviews as well.

24 Next slide please. So getting more into 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 44the process and timeline. After you submit your 1 application, first thing the NRC staff does is review 2 the application to see if we have enough information 3 to accept it for docketing.

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

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

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

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

23 And following that, our technical review 24 ultimately will result in the publication of a safety 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 45evaluation report. Which documents the NRC's findings 1 on the application and our recommendation to the 2 commission on whether we believe the construction 3 should be, permit should be granted or not.

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

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

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 46Next slide please. So I put together a 1 sample 22 month safety review timeline that's based on 2our previous reviews. And also just kind of a middle 3 ground between that 18 to 24 month time period.

4And I wanted to highlight just some of 5 what went into that so it doesn't, it isn't a complete 6 mystery of what we're doing while we're reviewing your 7 application.

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 47 So after about nine months, our goal would 1 be to have received responses from you on all of the 2 requests that we have issued. Following that, 3 reviewing the information and providing request for 4 additional information, it may be necessary to ask 5 additional RAIs.

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

10 After all of our requests for additional 11 information have been answered, and the staff is able 12 to complete a safety evaluation report, then we go the 13ACRS. And right now, in this timeline, we have about 14 19 months after accepting the application for 15 docketing, we would hold our first ACRS subcommittee 16 meeting.17 Based on our past experiences, with 18 licensing similar applications, we have seen that it 19will be likely necessary to have multiple ACRS 20 subcommittee meetings.

21 In this timeline we have anticipated there 22could be two ACRS subcommittee meetings. And these 23 can be held, essentially you would have an 24 opportunity, at most, once a month, while the ACRS is 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 48 in session, to meet with them to discuss that.

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

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

12 Next slide please.

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

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 49MR. FOWLER: And what I -- pardon the 1 interject here, but I see, you know, the objective 2 that I have in this meeting are to explore, how do we 3 accelerate schedules.

4 MR. LYNCH: Yes.

5MR. FOWLER: And I appreciate this 6 outline. There is implicit assumptions about cycles 7 in here.8 And that's an obvious opportunity to 9 reduce the overall time, if we reduce the number of 10 cycles.11 MR. LYNCH: Yes.

12MR. FOWLER: What is less clear to me is, 13what drives subsequent cycles? Is there a threshold?

14 What's the bar that we, as a company, need 15 to meet to avoid a subsequent cycle and therefore 16 accelerate the schedule? That's what's not so clear 17 to me.18MR. LYNCH: So I think that there's a 19number of things that we can do. And when we ask, 20 what we can do is, when we ask, request for additional 21 information, it's important that you understand the 22 questions that we're asking.

23You can go to the next slide. Let me 24 answer your question and then we'll go through the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 50slides as well. You can click to the next slide. But 1it's all related. That's the next topic I was getting 2 to.3 But when we issued the request for 4 additional information, it's important that after 5 they're sent to you, you have them, read through them, 6have a phone call with us. If we need to meet, we can 7 do that as well.

8 But we want to make sure that for every 9 question we ask, you clearly understand what we're 10asking. And if you don't understand, you ask us to 11 clarify.12 Because it cannot be the best use of 13 either of our times if you don't understand the 14question we're asking. You answer what you think 15 we're asking, but that's not what we're looking for, 16 then we have to ask the question again.

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 51 So I think one of the keys two reducing 1 the iterations that we have to go through in that RAI 2process, is making sure that you understand the 3 question that's being asked and providing complete 4 responses to that.

5MR. FOWLER: So we're learning how to work 6 with each other?

7 MR. LYNCH: Yes.

8MR. FOWLER: And we've had some 9experience. And, Nancy, maybe I can put you on the 10 spot here because we've now had two cycles of requests 11 for additional information with the environmental 12 portion of the technical review.

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

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

20 So in order to be productive, help us to 21 understand, from the limited experience we have 22 already, how we could do it even better on the next 23 cycle.24MS. MARTINEZ: So for the environmental 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 52 review RAIs, the second round of those RAIs were 1 driven by follow ups to the first round where the 2question was not addressed adequately. So we had some 3 follow ups on that.

4 But we also had some follow ups on the 5 responses because information was provided, and then 6 we needed additional information just based on the 7response. It was really a combination of some of the 8 questions were not answered completely, and then there 9 was responses provided, and then we had follow up to 10 that.11 We also did, you know, when we issued the 12 RAIs, as Steve mentioned, we did say, let us know if 13 these are clear and if you would like to have a call 14 to discuss them. We did that for both rounds.

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

17MS. GAVRILAS: I want to take it a step 18higher, because this is general. So you mentioned the 19two cases. Indeed, those are the two instances for 20 which we ask additional RAIs.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 53 So when they ask, when they request 1 additional information, it's designed specifically to 2augment the piece that they're writing right now. So 3that means it truly -- they know exactly what they 4want. Or they have a very clear picture of what they 5 want.6 I'm not saying that the peel the orange, 7 you know, or onion, whatever you're peeling, doesn't 8happen, but that's rare. Because of how we do, how 9 the expectation is that when you ask an RAI, you 10 basically know what kind of information you're seeking 11 to document your safety conclusion.

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

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

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

23 That is, in our experience, the most 24 efficient and effective way to deal with responses for 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 54 additional information.

1 MR. LYNCH: Nicholas?

2MR. TIKTINSKY: And I'd like to add a 3little more on that too. A lot of it's nature of the 4 rounds of questions. And this is Dave Tiktinsky.

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

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

16So really it's the nature of how the 17 information was in the application, how specific it 18 was. And really the level of what that question is.

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

22MR. ADAMS: And, this is Al Adams, I just 23 want to build on something Mirela said. That that 24 discussion that we have, once you start to develop 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 55 your answers, that's not a sort of a verbal review of 1 your answer.

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

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

15MS. GAVRILAS: And we cannot, this is 16 Mirela again, we cannot emphasize enough how important 17that dialogue is. Those are the, probably the biggest 18 contributors to our expediting the review.

19MR. LYNCH: Okay. Actually, so I think 20we've talked mostly through Slide 30. Let's go to 21Slide 31, which will continue this conversation we 22 have on impacts to schedule.

23 And this, in addition to RAIs, there is 24 other things that we can do to help ensure that our 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 56review is moving along efficiently. And can impact 1 schedule.2 One is the quality of the application 3 where all the regulatory requirements met. And this 4 is, I'm speaking hypothetically and not in your 5 application.

6 But if we do a review of the application 7 and the regulatory requirement is not met, it could 8 result in the application being rejected and needing 9to be resubmitted. Or it could result in significant 10 new information that does need to be presented and for 11 review.12Technical and completeness. Again, the 13 more information you give us without having to ask for 14 it, the more efficiently we can review the 15 application.

16 And then also just attention to detail.

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

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

22 Then building on our conversation on 23 request for additional information, in addition to the 24 number of rounds we ask, the quicker that you provide 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 57 responses to us, the quicker we can continue on with 1 our review.

2So timeliness, responsiveness, 3completeness of our requests and how you provide 4 answers to them, that can all help facilitate our 5 review.6 And I think a good point that Dave 7 mentioned was, what can take more time is if in these 8 requests for additional information, significant new 9 information is provided that we have not reviewed 10before. That can take additional time. And could 11 result in additional requests.

12MR. ADAMS: Can I -- Al Adams. Can I jump 13 in here?14 And completeness is probably the most 15important of those things. If you, you know, we asked 16 for a 30 day response and you come in in 20 days and 17 look, you know, you've come in ten days sooner. But 18 those answers aren't complete and result in another 19 round of RAIs, that round is going to consume a lot 20 more than the ten days that you saved by coming in 21 early.22 So completeness is the most important, I 23think, aspect of this. And I think what you're seeing 24 is, you know, the thing that draws out schedules is 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 58 having to go additional rounds of RAIs.

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

4MR. TIKTINSKY: Another thing I might want 5 to add too is, we're not going to wait till the end to 6give you all the RAIs at one time. You saw that, the 7 schedule that Steve had shown there.

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

12 So when we're done with an area and we 13 feel like we're done with that part of the review and 14comfortable with that, we'll ask those rounds of 15questions. But we want to spread it out over that 16 time period, the six month time period that Steve had 17 outlined.18 It's more efficient that way and it allows 19your staff to work on it. Also, we don't want to hold 20 somebody up, you know, waiting for another disciplines 21 review to be done.

22MR. ADAMS: So you may get a second letter 23 from us, but it's actually the first round of RAIs in 24that area. And there's nothing to be gained by 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 59 sitting on the RAIs and giving you a hundred questions 1 at once and overwhelming your ability to answer.

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

5MS. HELTON: This is Shana Helton. I'd 6 just like to reemphasize that when, especially when 7 you're crossing different portions of the regulations, 8 that the clearer you are in your initial submittal 9 about, this is how we're meeting 70.32, this is how 10 we're meeting 50.20.

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

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

20 I mean every applicant wants to avoid 21 going multiple rounds of request for additional 22 information. But it's just been our experience that 23 when we have to do those basic sort of questions 24 about, how are you meeting our regulations, that tends 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 60 to, once we see the detailed technical information, we 1 tend to then have questions about that.

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

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

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

6MS. GAVRILAS: More comments on RAIs.

7 Because I want to --

8MR. MORRISSEY: No, I had just a 9discussion about the technical reviews. My name, 10 Kevin Morrissey.

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

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

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

24 That would be my advice.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 61MS. HELTON: Absolutely. Getting the 1 technical experts to communicate directly so there's 2an understanding, is a good practice. To have a 3 public meeting on those RAIs.

4MS. GAVRILAS: So again, it's important to 5sum up. It's important to distinguish between various 6 increments at the same round, the RAIs and follow up 7 RAIs.8 The increments are designed to help us 9 all. To move the process along.

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

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

17 we've talked a lot about RAIs and how you can do, what 18 you can do to basically help us out, speed the process 19 along.20 But what's important in our timeline is 21 also to recognize that there's a safety reason for how 22the timeline is developed. There's nothing that's 23 carved in stone, because it's arbitrary.

24 And I'll give you, as an example, the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 62 writing of the SER. It doesn't help to distribute a 1chapter in a technical area amongst reviewer. That 2won't speed up the process. The review has to be 3comprehensive. The reviewer needs to see everything.

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

10 And with that, I'll turn it back to where 11 it was.12MR. LYNCH: Sure. Back to Slide 31.

13Again, this is Steve Lynch. Other impacts that, to 14 schedule, could be if there are policy questions that 15need to be resolved. I can give an example from a 16 past, a past review.

17 In the case with SHINE, we had to go to 18 the commission to resolve how, you know, whether SHINE 19 should be under Part 50 versus Part 70, and we ended 20 up needing to do a rulemaking in order to classify 21them under Part 50. That can be a potential impact to 22 schedule if that's something that's necessary in our 23 review.24 Also, the one thing that can drive 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 63 schedule, is the number of times we have to go to the 1ACRS. Limiting the number of subcommittee meetings 2 that we have to have, by addressing the technical 3 concerns with the ACRS, can significantly improve or 4 delay the schedule.

5MR. ADAMS: Al Adams. I just want to, the 6 ACRS tells us when they've received enough information 7 before they can write the letter they need to write to 8 the commission.

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

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

14MR. LYNCH: Yes. And what we can do to 15help them is, when they do identify areas that they 16 need additional information, that both the applicant 17 and the NRC staff provide that as quickly as possible.

18 All right, next slide please. So on the 19 previous slide I was mostly addressing the things that 20 both the applicant and the staff can do to impact 21 schedule.22 This slide is focused on the things that 23 are outside of the staff and the applicants control, 24 to a certain extent. And this gets into the hearing 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 64 process.1 And this comes after the ACRS meeting has 2 been held, the staff has completed its environmental 3 impact statement and the staff has completed its 4 safety evaluation report.

5 There will be a mandatory hearing on this 6application since it is a commercial facility. And as 7 I just mentioned, but there's a lot of things that 8 have to happen before this mandatory hearing can be 9 held.10 In addition, there is a potential, and we 11 put this out in our notice of opportunity for hearing, 12members of the public could file a contention on a 13 portion of the application or the activities that are 14 being conducted. Or proposed.

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

18 After any hearings that need to be held 19 are held, including the mandatary hearing, then we get 20 the Commission's decision to deny or issue the 21construction permit. Based on what we've seen for the 22 combined operating license applications, that have 23 followed a similar process to this, we have seen the 24 commission decision come anywhere between two and five 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 65 months following the mandatory hearing.

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

5 Next slide please.

6MR. BALAZIK: Hey, this Mike Balazik. I'd 7 like to provide a quick status update on the NRC's 8 review of Northwest construction printout application.

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

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

17 As you can see on this schedule, the staff 18 has targeted September of 2017 for completing the 19 safety evaluation report. And then there's a couple 20 of milestones that we can't really put a date next to 21 yet.22 There's a couple of related activities, 23not on this schedule, I'd like to mention. One is the 24 license amendment application by Oregon State 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 66University to irradiate three prototype targets. This 1 amendment was issued in January of 2016.

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

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

13MR. LYNCH: Okay. While we're on this 14 slide, do you have any questions about our review 15 schedule?16 I think, and this is mostly based on 17previous reviews and the sample timeline that we 18 developed. Do you have any questions on where we're 19 going?20MR. FOWLER: Well, I have an observation.

21And I appreciate this information. And I was somewhat 22 familiar with reading it.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 67 Obviously you have an ombudsman role and a review role 1 that is independent and so forth.

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

6 They see this as a real issue that we do work 7 together.8 They are not for profit organizations.

9 They have a service mission to the American public.

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

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

16 How can the NRC better set our 17 expectations of what will minimize those rounds of 18 RAIs?19 How can we work together to ensure that 20 the ACRS review is done in a single pass, rather than 21 two or three passes?

22 What do we need to do together?

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 68 But if we know what the threshold is that 1 we're trying to reach, we will work our darndest to 2get there. And that's what we're looking for. Is, 3 how do reduce the number of RAIs?

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

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

11 And that's the exploration that I'm very 12keen on hosting.

Because I think we have an 13understanding of the process. Now how do we work 14 within that process, to have the most expedited 15 schedule possible?

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

22 So this is all heading towards completing 23our draft safety evaluation report. So I guessing 24 you're looking at drive, making that June 2017 time 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 69 come up sooner.

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

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

8 MR. LYNCH: Yes.

9MR. FOWLER: You have insight by the 10 technical reviewers when an RAI is going to be issued.

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

17MR. LYNCH: There are different ways that 18 we can do this. Yes.

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

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

24 Now it also depends on the nature of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 70discussion you would like to have on the RAIs. The 1 public meetings are more necessary if we need to have 2 detailed technical discussions about the RAIs.

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

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

12So it kind of depends on what we need. So 13that can buy some time too. If it doesn't need to be 14 a public meeting, that can be done much more quickly.

15MS. HAASS: Well, and that's why there was 16 the request, when we were at the EDO, was to go get 17 that standing meeting done every week, very short and 18sweet, to say, okay, do we understand this. And then 19 we move on.

20 And so I'm glad that that got instituted 21 or executed that we're now doing that. And that has 22 helped.23 MS. HELTON: I think when you talk about 24 the frequency, the right frequency for the standing 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 71 public meetings, and they haven't been established 1yet, but we certainly can do that. And we've got 2 other examples working applicants where we've met on 3 a biweekly basis.

4 So in terms, I wanted to chat and, I'm 5 sorry, this Shana Helton, about this question on 6 threshold. And what's the regulatory threshold that 7you have to meet, as the applicant, to operate this 8 facility.9 So the regulations, we went over the 10 NUREGs as they've been supplemented by the Interim 11Staff Guidance. That is what we have set as the 12 threshold, if you will.

13 And each applicant is going to meet those 14regulations in unique ways. With that said, you know, 15we operated in a public manner. Everything is on the 16 docket.17 We've alluded to similar reviews in terms 18of looking at reducing the number of RAIs. I think it 19 would be helpful for you to do some research in ADAMS 20 for what similar designs, the types of requests for 21 additional information that we have had, and the types 22 of responses that have satisfied those additional 23requests for information. And that should really help 24 to identify the threshold.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 72 I mean that said, each application is 1different, we review it on its merits. We're going to 2 have to take into consideration the unique factors.

3 But that can at least give you a sense of the way we 4 think when we're going through these regulatory 5 reviews.6MR. LYNCH: Absolutely. I think that's a 7 very good point. And even more detailed in that, if 8 you really want to see, if you open up the safety 9 evaluation reports we write, especially those -- you 10 can look, for a good example, we just finished our 11safety evaluation report for the SHINE review. And 12 using the same guidance that you used.

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

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

24 So when we're looking at your application, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 73 we're trying to answer those questions. If we can't 1 answer a question affirmatively, that's one of the 2 times we'll go to you for a request for additional 3 information.

4 Also, as you'll realize for a construction 5 permit, you may not have all of the information that 6you would submit at the operating license stage. What 7 can also help the reviews is an explana tion of the 8information that you don't have right now, because 9your design isn't compete, explaining why it's not 10 ready right now, but also acknowledging that you 11 recognize it is something necessary for the final 12 design.13The more, again, it comes back to the 14completeness. The more informa tion that you can 15 provide us, addressing the information that we're 16looking for in the guidance, the quicker we can get 17 through the review.

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

22 However, if you can expedite the review, 23 it does make it easier if it's generally aligned with 24the guidance that we're using to go through with. So 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 74 that's some other insight.

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

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

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

17 There's security related information.

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

24 So what we try and, you know, we develop 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 75 in RAI, we try as best as we can to make the RAIs 1themselves publically available. So that information 2 is out there.

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

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

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

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

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

19But yes, we do plan things out. We try 20and coordinate that carefully with the reviewers. And 21 we know where the status of things are.

22 And again, that's why I mentioned before, 23 we're not going to just consolidate a bunch of 24 different disciplines and do it at one time, we're 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 76 going to try to phase this through, review it and try 1 to make it as efficient as we can.

2MR. ADAMS: And this is Al. I'll just add 3two things. One is, NUREG-1537 is a guidance 4 document, but it is an important document in that it's 5 a format content guide and the staff standard review 6 plan.7 What we expect for RAIs is that the RAI 8 will start by saying, either here's a regulatory 9 requirement or here's something that the standard 10 review plan is looking for, here's where your 11 application, the information in your application seems 12 to say something different or doesn't seem to have 13 this information. And then the question will come.

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

16 The other thing, you talked about the ACRS 17for similar application to yours. There are 18 transcripts of the ACRS meetings. You can go read 19those transcripts and see what areas interest the 20 ACRS, what areas they focused on, where they asked 21 both us and the applicant questions and issues that 22 became, you know, issues that were sort of follow-on 23 issues.24 So there is an advantage for you being 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 77 second in the queue that there is information that's 1 available to you. And that's an important source of 2 understanding how the ACRS works, what they think, 3 what they look at, what they consider important.

4MS. HELTON: Also publically, this is 5 Shana Helton again, also publically available on the 6advisory committee is their charter. You know, I 7encourage you to look at that. They're mandated by 8statute. They're an advisory buddy to the commission.

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

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

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

21 Sometimes they make --

22MR. LYNCH: Subcommittee does, full 23 committee does not.

24MS. HELTON: Full committee does not. So 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 78 I'm just saying, there is some limitations in working 1with the ACRS. They have a statutory role to fulfill 2 and they take it very seriously.

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

7MS. GAVRILAS: This is Mirela Gavrilas.

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

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

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

18 MS. HELTON: Absolutely.

19MR. BALAZIK: This is Mike Balazik. I 20 guess I just have one question. We've been, for the 21 environmental review, we've been through two rounds of 22 RAIs.23 We have been sharing those in draft form.

24We've offered calls. I mean, is there more that we 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 79 can do on these?

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

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

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

15And so I do think it's complete. And it's 16 sitting here for you.

17MR. BALAZIK: But it, this is Mike Balazik 18--19MS. HAASS: Now, there really isn't 20 anything else we can do accept keep communicating.

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

24MR. BALAZIK: This is Mike Balazik again.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 80 There's a difference between the weekly status call, 1 which is just overall --

2MS. HAASS: I know the staff, knowing what 3 we had and where there is a question and how we would 4go about resolving that. And it could be a public 5 meeting or it could be just, you know, there was a 6 misunderstanding and it was just a quick, you know, we 7 understood it.

8MR. FOWLER: So I see three areas that 9offer opportunities to explore expediting. The first 10I'll call administrative in nature. And those are the 11 mandatory noticing periods, the number of meetings and 12 so forth.13The better we can be in advance of 14 understanding when those need to happen, we can 15 eliminate more time that's simply waiting for one of 16 these periods. Or waiting to have a meeting.

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

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

22Then there's this area of technical. And 23 what I'm -- I've heard the term, completeness used 24 sufficiently that it will be lodged in my memory.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 81 And so -- and that comes through dialogue.

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

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

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

9 What threshold do we need to meet.

10And that's really on us. We've got to do, 11 and have been doing and will continue to do, research 12 into threshold regulatory.

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

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

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

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

24 So let me go with, as far as the status 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 82 meetings are concerned, that's our practice. So I'm 1 not sure when we implemented it, but I know that we 2 had the same --

3MR. LYNCH: We talked about it in 4November. Or no, actually August, at the National 5 Academy of Science --

6MS. HAASS: It just didn't get implemented 7 until about a month ago.

8MS. GAVRILAS: Okay. But that is part of 9our practice. To have those status meetings. But 10 their status meetings do not touch on anything that 11 Nick just mentioned.

12Okay. So as far as communication, that's 13what I was writing. The regulatory guidance is the 14 first place to look to see what the yardstick is for 15 completeness.

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

18 So they come in addition.

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

22 So we need to work together. As soon as 23 you identify a need for further discussion, you need 24to let us know. And we'll do our part in anticipating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 83 when it's likely that you will have additional 1 requests.2 Because, for example, if we know that 3 we're asking a broad reaching RAI, like Dave just 4mentioned. If we're asking you something, what was 5 your methodology, then we can see how that would 6 require an intera ction in the public to discuss 7 further.8So it's both sides. We both need to be 9aware. And I think we can both, at least we can 10 committee to our part, to have that awareness and try 11 to be proactive.

12MR. BALAZIK: Yes. And this Mike Balazik.

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

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

19MS. HAASS: And that was a little 20 different understanding. But no, I'm just glad it's 21 done.22 MR. BALAZIK: Okay.

23MR. LYNCH: So, just to finish up with 24 this slide, did we help with understanding ways that 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 84 we might be able to help accelerate the schedule in 1terms of strategy? Any other questions do you have on 2 that right now?

3MR. FOWLER: I think I have a good 4 understanding of the areas that I tried to summarize.

5 MR. LYNCH: Okay.

6MR. FOWLER: And what I would like to see 7 and what I would ask of our team is, okay, now 8translate those areas into a plan. What are the 9 processes and procedures that we've put in place, what 10 are the accountabilities, what are the milestones, 11 what in fact are the definitions of success or lack 12 thereof so we know we're on plan or off plan.

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

15 MR. LYNCH: Okay.

16MR. BALAZIK: All right, this is Mike 17Balazik, I'll continue on. We want to go through 18docketing. Steve mentioned earlier what docketing 19was. And I just wanted to go through the timeframe 20 for docketing of the Northwest application.

21 First I'll start with the Part 1.

22 Northwest submitted Part 1 of its application three 23times. Once in October 15th, another time, 29th, and 24 November 7th of 2014. This was before providing the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 85 NRC with a version that was acceptable for processing 1 and conducting an acceptance review on February 5th.

2The NRC issued a letter to Northwest on 3 January 23rd notifying Northwest its application was 4incomplete and unacceptable for docketing. Northwest 5was allowed 30 days to supplement that application.

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

8The reason for some of the delays was 9 inappropriate markings of proprietary information.

10 Also, ADAMS had rejected the document due to numbering 11 of pages.12 When they see a document has so many pages 13 and it doesn't match up, they'll reject the document 14 and try and get it resolved.

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

19And just real quick on Part 2. They 20 submitted the application, Northwest submitted the 21application, on July 20th, 2015. However, due to 22 formatting and improper proprietary markings, the 23 application was not fully put into ADAMS until 24 September 18th.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 86 The staff completed its acceptance review 1in the mid to late November 2015. And before 2 notifying Northwest on its acceptance decision, the 3staff held a public meeting in late November. And 4 provided Northwest an opportunity to clarify its 5 requested licensing action.

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

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

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

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

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

20If you begin to do that, you have restrictions and 21 limitations. Because it is a very archaic system.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 87 And we had a lot of difficulty with your 1 system that we would have two different files, exactly 2 the same thing, one would be accepted and one 3 wouldn't. And we couldn't figure out why.

4 And it was taking too much of our time.

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

8 You have a graphic capability of 300dpi.

9Our logo is more than 300dpi. And it's on every page.

10 It just isn't worth our time.

11MR. LYNCH: I believe the 300dpi is a 12 minimum, not a maximum.

13MS. HAASS: No, it's maximum. I mean 14there's some real difficulties. And we have a premier 15 person who does our documents, and I'm going to tell 16 you, it is one of the more difficult systems that 17 we've ever had to use.

18 MS. GAVRILAS: So --

19MS. HAASS: You know, I don't want to take 20this meeting over with that, and we can discuss it 21 later, but --

22MR. FOWLER: This is an area, so fully 23understand the dates. We're well aware of the dates.

24 The report that I get from my team would characterize 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 88 the difficulties differently from the way the NRC 1 characterizes the difficulties of receipt.

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

8 Now it could be us, it could be the 9 system. But let's take it off and figure out how to 10 fix that.11MS. GAVRILAS: Just a point of 12 information. Quick one. The system is designed the 13 way it is because the intent of the system was to 14enhance transparency. So that the documents can be 15 viewed on the processors that were prevalent at the 16 time at which it was deployed.

17MS. HAASS: Right. And that was the 18 issue.19 MS. GAVRILAS: So it was an optimized --

20 MS. HAASS: Right.

21MS. GAVRILAS: -- optimized two aspects of 22 our mission. One is, openness, reached the broadest 23set of stakeholders. And the other one is, making it 24easier for our stakeholders, for another set of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 89 stakeholders, the applicants and licensees to use.

1MS. HAASS: Right. I mean it is a catch-2 22, but we also had to get to a point where we did it 3 the easiest for us because it would, you know, if you 4 have to take every graphic out and do everything 5 individually and save it individually, it becomes so 6 cumbersome that you will make more mistakes.

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

10 MS. GAVRILAS: Noted.

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

15 MS. HAASS: We --

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

21 And applications like --

22 MS. HAASS: We do put a --

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 90MS. HAASS: We've tried the CD submission.

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

3MS. YOUNG: Because I know you're 4 interested in saving time. And any unnecessary --

5MS. HAASS: Yes, but we're not going to 6 solve either problem today.

7MR. BALAZIK: I think this is a good spot 8 to take a quick break. Next we'll go into Part 70.

9So ten, 15. Let's take a 15 minute break 10and start at 10:30. All right, we're going to go mute 11 on the phone and we'll be back at 10:30. All right, 12 thank you.

13 (Whereupon, the above-entitled matter went 14 off the record at 10:14 a.m. and resumed at 10:33 15 a.m.)16MR. BALAZIK: Good morning. This is Mike 17 Balazik again and we are going to resume the public 18 meeting.19 Right now we are on Slide 36, the NRC 20Licensing Process. This is, we're going to be 21 discussing Part 70 and I'll turn it over to Dave 22 Tiktinsky.

23MR. TIKTINSKY: Okay. Thanks, Mike. I'll 24 kind of make a point, my presentation is generally 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 91 more, you know, general Part 70, but I have a couple 1 of things that came up from this morning's discussion 2 that maybe will help sort of set the frame.

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

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

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

20 So that's some other ways of making sure, 21 you know -- You know, a lot of the discussion was, you 22 know, you give us a quality application, well in the 23 CP you have already given us an application, so 24 whether, you know, maybe you would have done something 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 92 different in the future, it doesn't really matter now 1 if that's already there.

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

9 So just sort of to get started on Slide 1037, just a little bit about Part 70 requirements. You 11 know, Part 70 is relatively brought up if you have 12 broad regulation to cover a whole bunch of different 13things and it talks about, you know, establishing 14 procedures for issuance of licenses, you know, to 15 title to own, acquire, deliver, receive, possess, use, 16 and transfer.

17 So that's a quite a lot of different that 18 it covers. There is a lot of activities that are in 19there related to, you know, possession and use. There 20 is the scrap recovery and licensing a fuel cycle 21 facility.22 So that's, it's a -- Again, it's a fairly 23 broad regulation to cover a lot of types of facilities 24 and activities for special nuclear material.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 93The next slide, Slide 38. It's a good 1 example here of, you know, kind of in parallel to what 2 Steve talked about in Part 50, and these, again, not 3 to, tend to be comprehensive, you know.

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

8 So if there is information that you 9 already provided for your other parts of the facility 10 you don't need to repeat them, you can just reference 11 them.12 Again, the clarity of those references 13 helps the rev iewers a lot, you know, the use of 14 crosswalks, tools, you know, whatever is efficient.

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

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

23 So, again, it's the combining of 24applications and licenses. It's not just in 50, it's 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 94 in 70, it's in other parts, so you are allowed to do 1 that.2 Again, the biggest emphasis that I will 3 have on that is regardless of the form that it turns 4 out you need to be able to demonstrate that the 5 regulatory requirements are met and the clearer that 6 is demonstrated the easier it is to get through the 7 review process and then timeliness for that.

8 70.22, the content of applications, there 9 is various requirements in there. 70.23 talks about 10 approval, so, you know, 70 is a little different than 11 50, the requirements are somewhat different, the 12 findings are different, but they are sort of still in 13 parallel to the, you know, public health and safety.

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

21The next slide, Slide 39. So NUREG-1520, 22 which is the standard review plan that we use for a 23 fuel cycle facility license application, the first 24 thing to think about is the information that's in 1520 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 95 shouldn't be, you know, that much different than what 1 you've seen in 1537, the augmented ISG, because a lot 2 of that was taken from 1520 and some of it just copied 3 for the applicable portion so a lot of it is the same 4 types of methodologies that you would use for the Part 5 70 application under 1520 or already in 1537.

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

11 The regulatory findings in 1537 talk about 12 the regulatory findings for Part 50. So that's sort 13 of where the difference t he staff in its review of 14 Part 70 applications has to make Part 70 findings for, 15so it's sort of, you know, tailored to the specific 16 regulation.

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

22 Things that are usually smooth, if you're 23 trying to go, you know, veer a lot from what's in 24 there and you have to prove it, and your case may be 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 96 difficult, it may take more time.

1Again, it's not a definite on that. It 2 is, again, depending upon what it is and what is your 3 approach and what's appropriate for your particular 4 facility.5 Following formats that match something 6that we recognize are easier. Again, the easier we 7 have to track the information that we need, the easier 8 the review goes.

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

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

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

24The next slide, Slide 40. So sort of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 97 purpose of, you know, why we even have an SRP it's, 1 you know, if you have a, it's across the board for 2 quality uniformity of review.

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

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

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

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

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

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

24 You know, Part 70, what's somewhat 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 98 different than Part 50 is, you know, the chemical-1 related hazards that are considered in Part 70 based 2on the nature of the activities that are done under 3 Part 70 facilities.

4Next slide, Slide 41. So the guidance 5 that we have in the regulations of 70.31 for issuing 6 a license, so once we determine that all the 7 applicable regulatory requirements are met we can 8 issue a license in the form and then you will have 9 conditions as appropriate.

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

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

16 We have done this for other facilities.

17 Again, it's not different than any other fuel cycle 18facility. If you look at other fuel cycle facility 19 licenses you will a series of some standard conditions 20 and then other ones that are specific to that 21 facility.22 So we would expect something to be here 23for this, this particular activity also. Even in a 24 combined license you still have license conditions 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 99 that you find in there.

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

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

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

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

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

24 How would that work within the NRC?

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 100MR. TIKTINSKY: Well part of it is, and 1 exactly where and how many documents sort of depends 2 upon how you submitted it to us, but we --

3 MS. HAASS: But it was combined?

4MR. TIKTINSKY: We would have to make, our 5 SER would have to make combined regulatory findings if 6 we were making the regulatory findings on the Part 50 7 side.8 MS. HAASS: Okay.

9MR. TIKTINSKY: We would have conclusions 10for the Part 50 part. We would have to make 11 regulatory conclusions in the same document for the 12 Part 70 part.

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

19MR. FOWLER: More pertinent to the 20 previous conversation is does one pathway offer an 21 easier, faster schedule than the other pathway?

22MR. TIKTINSKY: It's hard to say in terms 23of the speed. Clearly, the easier you can make it on 24 us to understand what you are doing and, you know, not 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 101-- Again, I should say, if there is a long time period 1 between submittals of one and the other then, you 2 know, tech reviewers that reviewed one part have to go 3 back and look at it to make sure they have covered it.

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

7MS. HELTON: If we go ahead a couple of 8 slides I think we're going to get to that, too, but 9 Dave is also going to talk about the differences 10 between the 2-step Part 50 license and the 1-step Part 11 70 license.

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

17 MS. HAASS: Right.

18MS. HELTON: There is different -- You 19 know, you have seen that the bar for the construction 20 permit, it's a different bar, you don't have a design 21 set and --

22 (Simultaneous speaking) 23MR. FOWLER: And this is why from -- I 24 have narrowed it, the choices in my mind are narrowed 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 102 to two because we have to have all of our finalized 1 design complete for the operating license under Part 2 50, which is then a 1-step process because the first 3 step has been complete, or we submit it under Part 70.

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

9 MS. HELTON: It might be helpful to step 10 forward in the slides and see if we don't address 11 that.12 MR. TIKTINSKY: Okay. Yes, see if we go 13 through and see if I answered the question or not.

14 MS. HELTON: Yes.

15 MR. TIKTINSKY: How about that?

16 MR. FOWLER: Okay.

17 MS. HELTON: Sure.

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

21 Forty-three. So to sort go with what we 22 have looked at, so from what we have received in the 23 docket so far the staff doesn't believe we have 24 sufficient information to do the conduct review of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 103 target fabrication scrap recovery activities right 1 now. So I think --

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

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

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

8MR. TIKTINSKY: We just want agreement 9 then, we all agree that there is not, we don't believe 10 there is sufficient information.

11 And from our review of those activities, 12 you had mentioned in your application that you 13 believed they were under Part 70, so how we look at 14 them they, I guess the first part is they don't appear 15 to be covered by Part 50, so that's sort of, it's not, 16 it doesn't meet the definitions of production facility 17 under Part 50 and they appear to be subject to Part 18 70.19 So that's sort of our looking at what --

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

24 And for us to actually conduct, you know, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 104 the safety review and issue a license, because 1 obviously you would need to submit an application 2 meeting all the regulatory requirements.

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

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

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

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

18Again, going back to my first point of 19 making sure there is a good understanding of things 20 because for any facility pretty much in, or activity 21 in Part 70, there are some parts that apply and some 22 parts that don't apply just on the nature because Part 23 70 is a broad regulation.

24 You can, you know, control things like MOX 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 105 facilities, which is different than, you know, uranium 1 enrichment facilities, so there -- But the regulation 2 is written broadly, so, you know, your understanding 3 of what you think you need to meet, having discussions 4 on that would probably be useful to make sure we were, 5 you know, had some alignment, you know.

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

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

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

20The Slide 44 talked a little bit about 21 schedule and, you know, Steve had presented a schedule 22 to you, and that was a very good outline of the types 23 of activities that get done in a review, so what I 24 present here is sort of, you know, if you were just 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 106 submitting a Part 70 application this is what we would 1 tell you that, you know, it's typically about 18 2 months to do a review.

3 We do a technical review of the 4application. Again, whatever it was, if it was 5 submitted with the Part 50 or not we will do a 6 technical review of the applicable regulatory 7 requirements, issue additional requests for additional 8 information, draft a safety evaluation report, you 9 know.10 There is slight differences in terms of, 11 you know, the process and terms of, you know, there is 12 not a mandatory hearing for this type of facility in 13Part 70 compared to 50, so there's some, you know, 14 subtle differences.

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

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

23 If it's with it then we could do that 24 review in parallel, so it wouldn't be adding to the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 107 time.1 So, again, a lot of it depends upon where 2 you want to submit it, what is strategic, you know, 3 for your company, when you think you are ready to have 4 all the requirements.

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

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

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

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

22MR. LYNCH: And just to add on, and I 23think Dave is absolutely right. I guess what it comes 24 down to, I'm glad we're in agreement on the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 108 information itself that needs to provided and I think 1 that the main comment in terms of what's more timely, 2 the sooner we have the information the sooner we can 3 begin reviewing it, if that helps you in planning when 4 you submit.

5 But I think from a Part 50 standpoint it's 6 important to think about, also, that is there still 7 related activities that are happening under the same 8 roof.9 So in order for us to make our safety 10 findings under Part 50 for a production facility we 11 will be interested in how other activities happening 12 within that building could impact, and I'm sure it's 13 the same going both ways.

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

21MS. HAASS: Well and that was the concept 22 of our Part 1, Part 2 submission was we showed an 23 overall facility, because you are trying to show all 24 the safety-related activities, you know, and how they 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 109 interact with one another.

1 MR. LYNCH: Yes.

2MR. TIKTINSKY: Yes, it sort of emphasizes 3--4 (Simultaneous speaking) 5MS. HAASS: But I can't do one without the 6 other?7MR. TIKTINSKY: Yes, to emphasize Steve's 8 point, I mean we, you know, individually look at the 9 Part 50 portion of the facility we need to consider, 10 you know, an external, which isn't really external in 11 this case because it's maybe the room next door.

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

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

22MR. JOHNSON: So, Nick, did that answer 23 the question that you asked a couple slides back about 24 are there efficiency -- What a thought your question 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 110was, are there efficiencies with going one route 1 versus the other, submitting a separate standalone 2 Part 70 versus incorporating all of the, how you are 3 satisfying all of the requirements into the CP, is 4 that what you were asking?

5MR. FOWLER: Yes. And, further, is there 6 a material difference between the strategy of 7 application submission?

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

14In many companies it would be easier to 15 have a separate Part 70 application because some of 16 the conversations could be more easily 17 compartmentalized even though they do relate to other 18 things.19 What I concluded, rightly or wrongly, 20 there is not a material difference. And to be clear 21 from what's in my head there is a 2-month difference 22 right now between the critical path of us entering the 23 supply chain with quantities of moly under Part 50, a 24 2-month slip on the Part 70 puts Part 70 on the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 111critical path. That's how tight these two things are 1 together.2 Plugging in all of the assumptions from, 3 well the guidance that we receive from the NRC, there 4 are only two months d ifference right now and so if 5 there were a material difference in review process 6 cycle time it could very easily affect the entrance of 7 this critical isotope into the supply chain.

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

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

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

23 I've seen another complex application, I 24was in operating reactor licensing before this job, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 112 where, you know, we've had as many or seven or eight 1 pre-application meetings to talk about each of the 2 different technical chapters and what they're going to 3 be doing to meet the requirements, and you might want 4 to consider doing something like that just so there is 5 no surprises.

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

9 MS. HAASS: Yes, so --

10 MS. HELTON: Yes.

11MS. GAVRILAS: So just one reminder. This 12is Mirela again. Just one reminder that these are 13 estimates, the timelines, and we try to walk you 14through the parameters, that impact held with that 15 estimate that --

16 So it's almost like you are talking 17 project management, what we visualize in our mind is 18 sort of Gantt chart with the end in mind, you know, 19 how the review of these various activities basically 20 lead towards the point that which you get an operating 21 license.22MR. BALAZIK: This is Mike Balazik. Is 23 there any other questions on the Part 70 piece, 24 because now we're going to shift to something else?

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 113MR. ADAMS: And now for something 1 different.

2 MR. BALAZIK: All right, Al.

3MR. ADAMS: So what I'd like to do is, you 4 know, we have discussed the, you know, general 5 requirements for licensing, your proposed activities, 6 you know, we discussed where the current status 7 review.8 Using your cover letter for Part 2 of the 9 application and the NRC reply I'd like to try to pull 10 everything together and hopefully the goal here is to 11 reach a common understanding of how to move forward.

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

17 So, next slide. So, you know, here is I 18 think probably the most important statement from, well 19 one of the important st atements from your cover 20 letter, that you are applying to the NRC to obtain a 21 license for a production facility under 10 CFR Part 22 50.23So, next slide. So I think, you know, we 24 understand that statement that you are looking for a 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 114 construction permit for a production facility, you 1 know, to dig a little bit deeper that you are looking 2 for a license to construct a facility where you plan 3 to conduct activities to separate moly-99 from 4 irradiated uranium and other byproduct material.

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

7 There is three basic definitions of production 8 facility.9 One is facilities that are involved in the 10 formation of plutonium, basically plutonium production 11reactors. The other one are facilities that are 12 primarily separating plutonium, and there is the third 13 definition which is on the slide, any facility design 14or used for the processing of irradiated materials 15 containing special nuclear material.

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

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

24MR. ADAMS: And there is, you know, there 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 115 is a safety reason behind the definition and that's 1 when you are processing irradiated materials 2 containing special nuclear material basically you are 3 separating out fission products from irradiated 4 special nuclear material.

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

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

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 116 The other one is if you are, that if your 1 batches are less than 100 grams of uranium then it's 2not a production facility. You indicated that your 3 batches will be greater than 100 grams of uranium.

4 And the third is that if the irradiated 5 material that the fission product concentrations and 6 the plutonium concentrations are less than the cutoffs 7 in the definition then you are not a production 8 facility.9 So you indicated that you are not looking 10 to fall under any of those exceptions, which means you 11 are a production facility under Part 50.

12Next. So here is another statement in 13 your letter to us.

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

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 117 Okay, now Slide 49.

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

5Slide 50. So just to repeat what 50.31 6 and 50.32 say, so the regulations in Part 50 allows 7 combining of applications under Chapter 1 of 10 CFR 8 and Chapter 1 is all of the NRC regulations, so we, 9 you know, so applications can be combined.

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

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

19 MS. HAASS: Correct.

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

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 118 NUREG-1537 has a couple of statements that 1 are applicable to what you are proposing on doing 2here. Section 9-5 of NUREG-1537 contains guidance 3 that materials used in the production facility license 4 need to meet the regulatory requirements for that 5material. In other words, special nuclear material 6 needs to meet the regulations in Part 70.

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

11Fifty-two. So your cover talked about 12 embedded in the 10 CFR 50 license facility activities 13 under Part 70 and Part 30.

14Slide 53. As I mentioned, as discussed in 15 Section 9-5 of NUREG-1537 the Part 50 license can 16 include other activities, however, the issuance of a 17 Part 50 license doesn't automatically include other 18 activities, other licenses.

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

23 So I think as we said several times, at 24this time we don't believe that your construction 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 119 permit application has the information required to 1grant the additional licenses and I think we're 2 looking for a better understanding of what you mean by 3 when you say "embedded activities." 4Next slide. So this is an example of a 5Part 50 utilization of an operating license. We call 6them included activities. What I am looking for is to 7 understand if our included activities are the same as 8 your embedded activities.

9As you can see in this license the 10 different licensing clauses. Number 1 on this slide 11 that is the license for the facility, so that's where 12the license is granted for the Part 50 facility. This 13 is an example of a Class 103 license, which is similar 14 to the Class license you are looking for.

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

19 And so Number 2 is you see an included 20 activity, so you can see this is the Part 70 clause so 21 the included activities to receive, possess, and use 22 at any time special nuclear material, in this case 23 it's reactor fuel in accordance with the limitations 24 for storage and the amounts required for reactor 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 120 operation as described in the application.

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

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

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

17So, 55. You mention that the RPF will 18 include the fabrication of LEU targets which will be 19 licensed under 10 CFR Part 70.

20Fifty-six. So, you know, we understand 21 that, you know, you understand that the fabrication of 22 targets is under 10 CFR Part 70 as we discussed 23 several times and this was reflected in our docketing 24 acceptance letter which stated that staff expects that 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 121 and Northwest will submit an application for 1 fabricating low-enriched uranium targets under 10 CFR 2 Part 70.3 And next is 57 --

4 MR. FOWLER: So I want to --

5 MR. ADAMS: Yes?

6MR. FOWLER: Al, I I'd just to clarify 7 that.8 MR. ADAMS: Sure.

9MR. FOWLER: Part of what triggered a 10 serious of conversations was the meeting immediately 11 preceding Thanksgiving in which our internalization of 12 the communication was a requirement to bifurcate our 13 application between Part 50 and Part 70.

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

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

24MR. ADAMS: It's still that type of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 122license, but, you know, there is choices on how you 1 put in your application, there choices on how the 2 license looks.

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

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

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

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

15MS. HELTON: Yes. Just to add to that, I 16agree. This is Shana Helton for the phone. The point 17 I think back at the Thanksgiving meeting that is being 18 reinforced today is that we need to see something from 19 you that demonstrates compliance with the requirements 20 in Part 70.

21 MS. HAASS: There was --

22MS. HELTON: Right. So I think that's --

23 (Simultaneous speaking) 24MS. HAASS: Right, but there was never any 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 123 disagreement with that when we were socializing it 1 when we had originally sent our letter over a year 2 ago.3 MS. HELTON: Right.

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

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

13MS. GAVRILAS: This is the main objective 14of this meeting. We need to make sure that all the 15 areas where there is uncertainty, where we are not 16 aligned, today is our opportunity to address them.

17 You know that's why we exchanged the 18 topics that we covered today with Carolyn before the 19 meeting to make sure that everything that we are 20 presenting here does address your concerns and does 21 actually get us to the point to which we can align on 22 the things that have some uncertainty associated with 23 them.24MR. FOWLER: And so to that point I see 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 124 everyone's head nodding that we are now in alignment 1 with respect to the previous kind of crosswise 2communications on 70 and 50 and for that we can 3 successfully tick off that as we have met that 4 objective of the meeting.

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

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

11MR. ADAMS: And I think I have one more 12slide. Number, I think Slide 57. So that the current 13 application that you are not, at this point you are 14 not seeking an operating license for the proposed 15 facility.16 This is a discussion we would like to have 17 with you today to the extent, you know, that we can 18 have it as to what your plans are for submitting your 19 operating license application because that does 20 influence timing, that does influence, you know, what 21 we do on, you know, what we need to do and what you 22 need to do, too.

23 So, you know, that's an area that we need 24 to, that we'd like to understand better for, we're 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 125 prepared.1 The second point, current application does 2 not request a license to produce SNM for the 3 fabrication of LEU targets, I think we beat that one 4 into submission.

5MS. HAASS: Well it doesn't, it's not a 6 current operating license application.

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

8 MS. HAASS: It's Part 70.

9 MS. HELTON: Right.

10MR. ADAMS: Yes. That's right, and that's 11 a separate point from my first one.

12 MS. HAASS: Right.

13MR. ADAMS: And a facility can have 14 multiple licenses, that a single building can be a 15 place of use under multiple licenses.

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

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

24 MS. HAASS: Yes.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 126MR. ADAMS: So that's the important thing, 1 but there is no rule that says that, you know, a 2 certain piece of turf can only, you know, can only be 3 occupied by one license, and I think that is 4 consistent with what we have discussed today.

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

11 That's it for me.

12MR. BALAZIK: All right. Real quick, this 13 is Mike Balazik again, and I know we have touched on 14 some of these topics but I just want to reemphasize 15 them.16 On communications, that internal and 17 external communications is important to support a 18quality and timely application review. I just wanted 19 to go through some of those channels that we have 20 already set in place.

21 One that Shana mentioned early in the 22 meeting about essentially one-stop shopping, that I am 23 your contact even though you've got, down the road 24 there is potential licenses, I am your main contact, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 127and, you know, on a lot of our calls, on our weekly 1 status calls I'll have Dave and Nancy on those calls.

2 The next item, clarifying, calls for REIs.

3 We've done a couple of those for the environmental and 4 we plan to continue those for the safety, sharing 5 those RAIs with you draft form, make sure there is an 6 understanding, and if there is not, you know, we can 7 discuss it and even modify the RAIs so that it is 8 clear.9 Since we are discussing RAIs I'd just like 10to share one item for thought going forward. Even 11though there is no regulatory requirement to update 12 your PSAR, we've seen a good practice, or identified 13 a good practice that if you update your PSAR with the 14 RAIs that that can also lead to a timely review, but 15 even future steps it will help us, to keep your 16 updated PSAR.

17 But realize there is no, you know --

18MS. GAVRILAS: I'll just mention one 19thing, ACRS. It's easier for the ACRS, we accept your 20 responses, right, as a supplement to your submission, 21 they become part, they are docketed and they become 22 part of the docket.

23It makes it much easier when the ACRS 24 looks at the package to have the package as complete 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 128 as possible.

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

4MS. HAASS: So a good example is the RAIs 5we have received on Chapter 19. We've already updated 6Chapter 19. You have not received it, but we have 7 already updated it.

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

14 MS. GAVRILAS: That's terrific.

15MR. TIKTINSKY: The practice that we find 16 that works a lot is sometimes, you know, answers to 17 RAIs are long but changes to the applications don't 18 necessarily, aren't -- Well you might change one thing 19 in an application and have a 3-page thing backing it 20 up.21 MS. HAASS: Right.

22MR. TIKTINSKY: So at the end of the day, 23 at the end of the review it's good to have one 24 application that we know everything that's in the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 129 application that we can write an SER against rather 1 than writing SERs against all these little sort of 2 sidebar discussions.

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

7MS. HAASS: But remember it's difficult 8 for us to manage if we don't do that. That makes us 9 inefficient, so it's only good practice on our part 10 and to move forward to the operating license.

11MR. TIKTINSKY: That could be changed 12pages, you know. It doesn't have be, you know, every 13 time you make something it doesn't need a whole 14 chapter, it's just whatever related to, you know, the 15 change from an RAI and is, you know, and you manage it 16 however you find most efficient.

17MR. BALAZIK: All right. Another item, 18 responsiveness, we've also talked about that, 19 especially timely response to RAIs and when we share 20 the draft RAIs if there is something that you see in 21 there that you can't get in 30 days or a certain 22 timeframe just let us know.

23 Let us know that this, hey, we can answer 24 RAIs 1 through 5 but, you know what, six is going to 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 130 take us a little bit longer. You know, we just need 1 that communication back and forth that there may be 2 something up there that may take a little bit longer.

3 Quality of submissions, we also talked 4 about this, identifying proprietary information, 5 removing that, and just that answers are complete.

6 Also, just clarify previous communications 7or socializing. We mentioned this earlier that no 8 regulatory decisions are made in public meetings and 9 that public meetings are not a substitute for 10 submittal of information on the docket and also that, 11 you know, we don't make decisions on our weekly calls.

12 And, finally, just that the NRC has an 13 opening policy and if we chose to close a meeting, you 14 know, it's reserved for informa tion that must be 15 withheld in accordance with our regulation.

16 So that's pretty much it for 17communications. I don't know if anybody else wants to 18 add -- Yes?

19MR. LYNCH: I just wanted -- I was really 20glad to hear that we were able to meet one of your 21 objectives in terms of licensing, that we have a 22 shared understanding that additional technical 23 information is needed for, to meet Part 70 24 requirements and how you choose to submit that is up 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 131 to you and regardless of how it is submitted it's 1 still the same technical information that we are 2 looking for. I'm glad we've got that objective met.

3 I want to make sure that we can also 4 hopefully meet that second objective that you stated 5 at the beginning, which was exploring mechanisms to 6 expedite the review.

7I tried making a summary. I think Mike 8highlighted them and I just kind of want to read 9 through those again and make sure that we understand 10 everything you are looking for and to reiterate our 11 points that can help facilitate that expedition.

12One of those areas we've talked a lot 13 about, RAIs, trying to reduce the number of rounds of 14 RAIs and even the total number of RAIs, things that 15 can go that, the quality of your responses, 16 completeness and the timeliness, we explore different 17 ways of communicating that to help facilitate that.

18Mike has his weekly status calls. We have 19 talked about -- and on the status calls we can make, 20talk further about if we want to set up standing 21public meetings. If that can help we can certainly 22 get those set up as well.

23 And broader with communication, you know, 24those weekly status calls are good opportunities to 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 132 identify problems you see coming down the road that 1 we, both parties can be thinking about and, you know, 2 maybe it's not something we address immediately, but 3at least we can put them on the list of things NRC 4 needs to think about and things that Northwest needs 5 to think about, and they can topics of future public 6 meetings.7 We can also talk about, you know, email 8communication works, too, send emails. You can update 9and propose topics that we can have on those weekly 10 calls, topics for public meetings, if we can get 11 those, and it helps, too, we can discuss ahead of time 12 before we have those calls.

13 Al touched on this, also that's important 14to us is updates to your schedule. This can be 15 updates as Mike was talking about with responses to 16 RAIs.17 If it's going to take you a little bit 18 longer to get certain responses to us work that out 19 with Mike, let us know what's going on with your 20 schedule so that we can plan and make sure that we 21 have people available and ready to review your 22 responses when they come in.

23 Also, when you plan on submitting 24 additional applications, primarily your operating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 133 license application, helping us have a good idea of 1 when that's coming in to make sure that we have people 2 ready to review it when it comes in.

3 So letting us know delays that might come 4 up or if your schedule is getting pushed up, it helps 5 us align our budget and our resources to make sure 6 that we are ready for your application.

7 We also talked about pre-application 8meetings. So when you are getting ready to submit 9 your next application for your operating license we 10 can have meetings ahead of that submission to make 11 sure that we have a shared understanding of the 12 information that's coming in that and have discussions 13 about that so it helps encourage that a quality 14submission comes in for your operating license and 15 could help potentially reduce that review time as 16 well.17 In talking about the operating license 18 application I wanted emphasize again, because 19 ultimately we complete this construction permit review 20 in our 18 to 24-month timeframe, we're still 21 anticipating an additional 18 to 24-month review for 22 the operating license application, and I understand 23 it's critical that we can get that review done 24 efficiently as well.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 134 So I think for those exploring, those pre-1 application meetings can be a good way of getting us 2 started on that review and knowing when it's coming in 3 can help us be prepared.

4 We highlighted following the guidance.

5 You can gain insight from NUREG-1537, the ISG, our 6 standard review plan, so you know exactly what the NRC 7 is looking for when we review the application that you 8 sent in, also looking at past applications that have 9 come in to get ideas of questions we have asked in the 10 past and the level of detail of information that we 11 found acceptable in the past.

12 We also talked about reducing 13 administrative time so that we don't have time that's 14 spent with people not doing anything, and I think 15 that's good and I think those weekly calls, again, are 16 going to be crucial to reducing that administrative 17 time for processing.

18 And Mike highlighted again at the end 19 updating the application as you are responding to 20RAIs. That was my list. Were there other things that 21 I missed that we can --

22MR. ADAMS: There's probably one I want to 23touch on. I think I touched on it briefly and that's 24 the operating license application.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 135 The last research reactor that we licensed 1 submitted a complete application at the construction 2 permit stage so our review was for both the 3 construction permit and the operating license at the 4 same time.

5 Obviously, that has the potential to, you 6 know, reduce the review time significantly so that's 7 why we are interested in knowing what's your timing on 8 your operating license that, you know, that has an 9 effect because, you know, the theory is that the 10 construction permit you've given us so much of, say, 11 you know, your complete design that you've given us so 12 much of that design and, you know, there is enough 13 there to make a decision to allow the facility to be 14 constructed and then the rest of the details on the 15 design come in with the operating license that, you 16 know -- so there is a lot of variability what that, 17 you know, what those parts, you know, what those two 18 parts look like.

19 The first part is here, you know, what 20 needs to come in to fill and, you know, to fill in the 21 rest of the information and when that information is 22coming in I think is important, you know, in the 23 discussion of, you know, how to change the, you know, 24 the timing of this and, you know, not only, you know, 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 136 talking talk the timing from, you know, the beginning 1 to you have an operating license.

2MR. TIKTINSKY: If I add a little emphasis 3 from Steve's point on the Part 70 side, you know, 4 there is many examples of the kinds of the RAIs that 5 we have asked for Part 70 applications as well as 6 SERS, so you can sort of see when we write up things 7 related to 1520 what the kind of things we're looking 8 for, the kind of questions we had.

9 And, also, you know, emphasizing of the 10 use -- You've got multiple things here, the use of 11 crosswalks, you know, again, the clearer that you can 12 make it that we understand where the information is 13 the easier it will be for the reviewers to get the job 14 done and minimize questions of because we just can't 15 find information.

16MR. FOWLER: So to the list that Steve 17 summarized very nicely I would add a program/project 18 management process, just as I manage a program inside 19 of a private company I have far less insight into the 20 detailed activities in what's happening at the NRC and 21 whether we're on track, off track, what are the 22 constraints, what are the barriers, those kinds of 23 things.24 So a consolidated program project 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 137 management structure I think is very, very important 1 to keep things on track.

2 MS. HAASS: Yes.

3MR. LYNCH: And I think to that, yes, I 4 think it's very important from both sides to keep each 5 other updated on where we are at in our reviews and I 6 think with the calls we can do that.

7 Also, what we're going to try doing is, 8 you know, keep you updated on our overall review 9 schedule. We have this initial review schedule that 10 we shared here today on our slides, but as things come 11 up that may necessitate that changing, either 12 expedited or delays, we need to communicate that to 13 you as soon as possible, and that's a commitment that 14 we can make as well.

15 We are also going to, you'll be seeing 16 shortly, we're working on developing a public website 17 that should be going live in the next couple weeks 18 that you can be able to also have all of your 19 application data displayed as well, that can be easily 20 accessed and see our review schedule.

21 MR. ADAMS: The public --

22MS. HAASS: The public would -- Sorry.

23 For Northwest Isotopes or for other things as well?

24 MR. LYNCH: Both. So Northwest specific 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 138 and general moly-99.

1 MS. HAASS: Okay, got it.

2 MR. ADAMS: And your public information, 3 not your --

4 MS. HAASS: I understand.

5MR. LYNCH: But, yes, and, you know, as we 6 continue with the review I'm sure both sides will have 7 new ideas.

8 MS. HAASS: Yes.

9MR. LYNCH: So chair them and we can 10 continue to improve.

11MR. BALAZIK: All right. At this point 12we're a little ahead of schedule. Our senior managers 13 want to come down for our closing remarks and summary.

14 The timeframe for that is 2:30, but I 15 wanted to ask Northwest if they had additional 16 discussion they want to do in the afternoon on any of 17 the topics we presented, any topics that we didn't 18 present today that they would like to discuss in a 19public meeting. I've got that scheduled for 1:30 and 20 lasting about an hour.

21 MS. GAVRILAS: Yes, I have a suggestion, 22 that we mull over everything we have heard and perhaps 23after lunch we reconvene and that will be the time, 24 unless you want us to research something over lunch.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 139 It's going to be after lunch we reconvene 1 and we sort of discuss any outstanding items, how's 2 that?3 MS. HAASS: That's fine.

4 MR. FOWLER: Sounds good.

5MR. ADAMS: And another question, is, you 6 know, giving us information on where you see your 7 schedule moving forward, you know, especially giving 8 us the operating license application, is that 9 something that you are prepared to talk to us today in 10 this swarm or --

11MR. FOWLER: We would certainly be 12 prepared to respond and provide some answers in a non-13 public format, as it's dependent upon a lot of the 14questions that were asked of us that are of a 15proprietary nature to come up with the anticipated 16 scheduled.

17 MR. ADAMS: Okay.

18 MR. BALAZIK: Okay.

19 MS. GAVRILAS: Enjoy lunch.

20 MR. BALAZIK: Yes.

21 MR. ADAMS: What time --

22 MS. GAVRILAS: We'll reconvene at --

23MR. BALAZIK: Well let's reconvene at 1:30 24 for discussion of additional topics and then at 2:30 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 140 we'll do the closing remarks.

1MS. GAVRILAS: Yes. And we have an 2 opportunity before the public to --

3MR. BALAZIK: Yes, we're going to do that, 4 too, yes.5MS. GAVRILAS: So we need to stick to the 6 agenda because --

7 MS. HAASS: Is there any opportunity for 8 a non-public portion of this?

9 MR. BALAZIK: No, there is not.

10 MS. HAASS: Okay.

11MS. GAVRILAS: So we need to stick to the 12 agenda because the agenda is made available so that 13 everybody can listen, so we'll just meet back at 1:30 14 and we'll talk more then.

15 MS. HAASS: Right.

16 MR. FOWLER: Very good.

17 MALE PARTICIPANT: Thank you.

18MR. BALAZIK: This is Mike Balazik. We'll 19 be coming back at 1:30 and we're going on mute until 20 then.21 (Whereupon, the above-entitled matter went 22 off the record at 11:32 a.m. and resumed at 1:35 p.m.)

23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 141 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 1 (1:35 p.m.)

2MR. BALAZIK: Hi, this is Mike Balazik, 3 and we want to resume the public meeting with 4 Northwest Medical Isotopes. Right now in the agenda 5we have Northwest Medical Isotope topics. If there's 6 anything that Northwest wants to discuss with the 7 staff?8MR. FOWLER: We did not have topics in 9public form. We'll arrange a separate non-public 10 meeting to discuss some topics.

11MS. GAVRILAS: Mike, you want to talk 12 about the setting up closed meetings please, because 13 apparently there was some miscommunication on what 14 requirements we must need before we can do that.

15MR. BALAZIK: Yes, the requirements for a 16 closed meeting is to submit an affidavit with the 17 letter, but with the specific topics that are going to 18 be discussed in the closed forum.

19 So then what we would do is we would look 20 at those topics and agree that yes, these are proper 21 to be discussed in a closed setting vice an open 22 public meeting.

23 So in the affidavit that was provided, I 24 felt that it was very general, and I received some 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 142 advice that it did not contain sufficient detail to 1 close the meeting.

2MS. HAASS: And as discussed with you, we 3 were, we didn't quite know what would be in the non-4 public forum because this discussion had to occur and 5that's why it was general. So it's not that we didn't 6 understand, it was because of how the meeting was set 7 up.8MS. GAVRILAS: I understand. So the other 9 thing that we tried to see is if it's okay for us to 10close a portion of this meeting. So that was the 11homework we did during lunch. And we were advised 12that that's not okay because the topics need to be 13 submitted by affidavit. So we tried.

14 MS. HAASS: It's a catch 22.

15 MS. GAVRILAS: Yes.

16MS. HAASS: But no, we do understand, you 17know, the requirements for a non-public meeting. But 18 we just didn't have enough data to be able to give you 19 any more specifics.

20MR. LYNCH: That's understood. Well 21 maybe, if we have some time maybe we could use for 22time our over here is to maybe make a list of some 23 action items that we can take for going forward, and 24 this could include topics for future meetings that you 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 143 might like to have, things you would like to see, and 1 other things you would like to go forward on both 2 sides that we can take back and then we can get back 3to each other on. Does that sound like something you 4 would like to go over?

5 MS. HAASS: I would say we can take some 6action items. But just as long as we know it's 7 subject to change because, you know, I still have some 8 discussions I need to do.

9MR. LYNCH: Understood, understood. Yes, 10this is not meant to commit you to anything. This is 11 intended to help us get an idea of when we leave here 12 today what should we be most focused on, aside from 13 reviewing your application.

14 Mike, did you want to lead with any topics 15 there?16MR. BALAZIK: One thing we've discussed 17 before, and again stop me if we're going into 18proprietary information. But one thing we've 19discussed in the past is facility design, final 20 design.21 And what we've talked about earlier are 22 our resources for future applications, future 23submittals. Is it possible we could get some sort of 24 idea of how far down that path Northwest is?

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 144 MS. HAASS: I think we can state that we 1are in the process of finishing our final design. But 2 from a schedule perspective, that would have to be 3 discussed in a closed session.

4MR. LYNCH: Yes, I think the topic from 5 that is what, something the NRC is interested in 6 understanding better from you is when will your final 7 design be complete, and also how do you think you 8 might consider submitting that because there are 9 different ways that the final design can be provided 10 to the NRC.

11 The final design can be provided as part 12 of your operating license application, or you can 13 amend your current construction permit with additional 14 design information as you finish it.

15 And however you choose to do that is fine.

16 But it does help us to anticipate when that 17information might be coming in. So that's just, that 18 is a topic that would be useful for us to discuss in 19 the future.

20MS. HAASS: Well, and I would be 21 interested, because this is the closed question, what 22have you preferred in the past? Would you like to see 23 it, like, you know, before the operating license 24 submission with the, maybe the finalization of the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 145 construction permit.

1 I mean, I don't know. I mean, I don't 2 know what's the best timing for you guys I guess I 3would ask. And then, you know, we'll try and work 4 that into a schedule.

5MR. LYNCH: I think for us, you know, 6 we're willing to work with you with whichever way you 7would prefer. You know, we haven't done something 8like this in a very, very long time. So I don't know 9 if there's a lot of precedent we can necessarily point 10 to.11 But I think we want to work with your 12proposal. And by notifying us when it's coming, we 13 can make sure we have the appropriate resources 14 available for that.

15MR. ADAMS: This is Al. I think, you 16know, the understanding of the timing is important 17 because we're going to, you know, spend time and 18 effort reviewing what you've given us.

19 And if we're 85 percent complete with that 20 review and all of a sudden we have a whole new bunch 21of information, it might be advantageous to finish 22 that 15 percent, take that licensing action and then 23try to reset, try to, you know, blend those two 24together and start reviewing sort of an expanded 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 146 scope.1 So you know, part of it depends on the 2 timing versus if we're only, like, ten percent into 3 looking at something and the new information comes in, 4 then the effort or cost of changing your direction, 5changing your scope is minimal. So I think that's an 6 important solution.

7 MR. LYNCH: Maybe that's a better way to 8capture what we can provide that too. We won't advise 9you on which way is better than the other. But we can 10 discuss, as Al was going to, what potential impacts of 11 your decisions could be.

12MR. BALAZIK: This is Mike Balazik. I 13 guess another potential item is exemptions. I don't 14 know if Northwest has looked at any potential 15 exemptions that could come down the road that we could 16 be aware of or could prepare for, just kind of another 17 item that would benefit us in future reviews on 18 exemptions.

19 MS. HAASS: Okay.

20MR. LYNCH: And even more broadly, just 21 other licensing actions in addition to your primary 22 construction permit or operating license, or material 23 license and application that we might need to consider 24 and the timing. And for example, that could include 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 147 the other research reactors that might be seeking 1 amendments to support that, knowing the timings that 2 those licensing actions can help us as well.

3MR. ADAMS: Another example would be if 4 there's any need for shipping packages that would be 5 unique to what you're doing that, you know, don't 6exist. That's another part of NRC and that's, you 7 know, a discussion that they have their own timelines 8 for doing that type of work.

9MS. HAASS: And we've had brief 10 conversations with the other organizations, too.

11 MS. YOUNG: And that's under Part 71.

12MR. LYNCH: Another topic that, you know, 13 that I think we could discuss going forward to our, 14 we've touched on the topic of potentially setting up 15 standing public meetings.

16 Put that on the list of establishing if 17 that's something that you want to pursue, what you 18 think appropriate frequency for those meetings might 19 be, what topics you might want to discuss during 20those. I think that, I took that as one of the take-21 always I had from earlier today as a topic we should 22 explore further.

23MR. BALAZIK: I guess, this is Mike 24 Balazik again, for expectations for interactions with 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 148 the NRC for the environmental review, we're pretty 1much had a set process. I mean, is there any 2 recommendations on communications that you would like 3 to see in the future?

4MS. HAASS: Just want to make sure that 5 the RAIs get reviewed prior to going out final to make 6 sure there's no business sensitive information in 7there. If you can at all let me know the possible 8 timing when that's going to come in, you know, we have 9 a lot of things going on as well and I need to make 10 sure our resources are there.

11 And I know when we get into the safety 12 aspect it can get more and more difficult, you know, 13 to get those reviewed, and what resources that means 14 to us as well.

15 Also from, Nancy, from your perspective, 16 I mean, you'll have another public-type meeting within 17the NEPA realm. And you know when you're going to be 18scheduling that. I know that the City of Columbia was 19 asking me that question as well.

20 I just know, you know, they told me they 21 would really like to help you do that. And I know 22 last time you guys went and did that, you know, 23 independently which is fine, but they're also willing 24to go help as well.

And, you know, you have their 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 149 contact information now.

1 MS. YOUNG: Okay, thank you.

2MR. LYNCH: Were there any topics that 3 you've had in mind in addition to that that you would 4 like to focus on in the future?

5MS. HAASS: No. I think when you start 6 looking at schedule, the other licensing actions and 7 the same in the public meetings, that's really where 8 we want to focus with you guys.

9 Obviously, the standing public meetings, 10 you know, we'll assume that there will be some closed 11 portions of those meetings within that, you know, with 12 the appropriate documentation, understand that.

13MS. GAVRILAS: Mike, you'll need to 14elaborate on the process. I think we need the 15 affidavit with sufficient detail --

16 (Simultaneous speaking) 17 MS. HAASS: Oh, that's what I just said.

18 Right, no --

19 MS. GAVRILAS: So that's --

20MS. HAASS: I said with the appropriate 21 documentation there would be closed portions as well 22 because there are certain things that, you know, that 23 are technically sensitive as well.

24 MS. GAVRILAS: Sure.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 150MS. HAASS: And so any time we have a 1 topic, assume that there's going to be some, there's 2 most likely going to be something business sensitive 3 in there if it has anything to do with some details of 4 the facility.

5MR. TIKTINSKY: You don't want to forget, 6 Dave Tiktinsky, the security related information 7 aspects of public meetings with technical discussions 8 which is different because that's a different part of 9 the regulations.

10 MS. GAVRILAS: Definitely.

11MR. TIKTINSKY: So that's always something 12 we want to make sure that, you know, why we close 13 meetings related to discussions of that and 14 information that's the integrated safety analysis or 15 things that are preferably security related.

16MR. BALAZIK: Anybody have anything else?

17MS. GAVRILAS: Open it to the public I 18 would say.

19MR. BALAZIK: All right, we can open up to 20the public. Actually, I do have one more item.

21Karen, you mentioned resources. Is there the 22 potential for any impact in the future for Northwest 23 resources for the review of this application, or even 24future applications? There would be no change or any 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 151 fluctuations that could potentially happen?

1MS. HAASS: Well, there's no change in our 2 primary subcontractors, no.

3 MR. BALAZIK: Okay.

4MS. HAASS: And they have the people to 5support this. But, you know, you still have to 6 schedule it.

7MR. BALAZIK: Yes, no. I understand, I 8 understand.

9MS. HAASS: So yes, but that is not going 10 to change.

11MR. LYNCH: I guess maybe just as a 12 closing question, do you feel like your expectations 13were met today? Did we accomplish what you wanted to 14 accomplish at this meeting, or at least start moving 15 in the right direction?

16 MR. FOWLER: So we had two objectives as 17we introduced this meeting from a Northwest Medical 18Isotopes perspective. The first was gaining alignment 19around or understanding in common of the licensing 20 application process.

21 And that one we've I think beaten to death 22 and are in violent agreement now with an understanding 23 from both NRC and from Northwest Medical Isotopes of 24 the options. And the follow up next step on that is 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 152to telegraph to the NRC our intentions. And so I 1 think from a first objective standpoint, we can 2 declare success on that one.

3 The second, and frankly more important one 4 to the nation and to public health and to public 5 safety is the speed with which we can accomplish a 6 successful review within the guidelines and 7 regulations.

8 I think this is, we did not have an 9 expectation that that would be solved in this meeting 10today. Our expectation was that we would have a plan 11 to get to a plan.

12 What we accomplished in my view today is 13 I've received more granularity in the schedule 14 elements from the NRC and the assumptions behind the 15 schedules, how many iterations of RAIs, how many 16 iterations for the RCS and so forth.

17 So I think we now have a framework with 18 which we can succeed in a productive conversation on 19 translating the list, Steve, that you've so well-20 articulated and added to and convert that into an 21 operating plan.

22 And ultimately, what it comes down to to 23a company like ours is predictability. Sufficient 24 granularity in schedules so we know what's next, how 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 153 do we assess that each one of those milestones whether 1 it's on track or off track, and our ability to predict 2 those next steps, manage accountability, manage 3 schedule, manage budgets.

4 The risk to any business, the biggest risk 5to any business is uncertainty. And we've been in an 6uncertain environment. And this meeting succeeded in 7 helping to remove some of the uncertainty in terms of 8 establishing a framework where we can now discuss the 9 schedule.10 And a number of the elements are going to 11obviously fall right back on us. We have better 12 expectations of what the standard is by which we need 13to meet. But I think we also can establish a program 14 management plan so we collectively understand when a 15 milestone's been achieved and what the next milestone 16 that we all need to focus on.

17MR. BALAZIK: And if there are no more, 18this is Mike Balazik, again. If there are no more 19 questions in the room, first of all I guess I would 20 like to ask if there's any NRC staff on the phone that 21 has any questions. And then we'll open it up to the 22 public.23 (No audible response) 24 MR. BALAZIK: Okay, hearing no questions 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 154 from the NRC staff, so now I would like to open up the 1phone lines to the public for public comment. Just a 2 couple of items.

3 Please, speak one at a time and identify 4yourself in speaking. And also if you're 5 uncomfortable asking a question on the phone, you can 6 submit your question to me via email at mfb@nrc.gov.

7 Are there any public comments?

8 (No audible response) 9MR. ADAMS: Can someone verify that the 10 phones are still open and working?

11 PARTICIPANT: Yes, the phones are open.

12MR. ADAMS: All right, we just want to 13 make sure silence wasn't something unplugged 14 somewhere.

15 MR. LYNCH: Thanks, Jenny.

16 PARTICIPANT: We're here, thank you.

17MR. BALAZIK: All right. So I think we 18 are, are we expecting Bill and others to join us 19 later?20MS. GAVRILAS: Yes. I think we'll adjourn 21 until 2:30 when we have an opportunity to interact 22with two office directors. I think at least one 23office director, perhaps two. And certainly my boss, 24 Lawrence Kokajko is going to join us.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 155 I don't know if Craig who is the acting 1 director in Shana's organization is also going to join 2us. So you'll have an opportunity to reiterate, we'll 3 reiterate our action items and you'll have an 4 opportunity to interact with them.

5MS. HAASS: And which office directors, 6 potentially?

7 MS. HELTON: Bill Dean.

8MS. GAVRILAS: Bill Dean, our director is 9 coming for sure.

10 MS. HAASS: Okay.

11 MS. GAVRILAS: And his deputy might come 12 as well.13 MR. ADAMS: So we're going to go mute on 14 the phones until 2:30 and then we'll be back on.

15 (Whereupon, the above-ent itled matter went 16 off the record at 1:54 p.m. and resumed at 2:33 p.m.)

17MR. BALAZIK: Mike Balazik, we're resuming 18the public meeting. Right now we're toward the end of 19the meeting. And we just want to real quickly go 20 through some closing remarks. Oh, I'm sorry.

21 Bill Dean, Office Director of NRR is 22 joining us, and Michele Evans has also joined us, and 23Lawrence Kokajko has also joined is. He's the 24Director of DPR, for our members on the phone. All 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 156 right.1 (Off microphone comments) 2MR. BALAZIK: Okay, can we just go through 3 everybody, identify themself that's new to the 4 meeting?5 (Simultaneous speaking) 6 MS. EVANS: Sure. Michele Evans, Deputy 7 Director of NRR.

8 MR. KOKAJKO: Lawrence Kokajko, Division 9 Director, Division of Policy and Rulemaking.

10MS. MARSHALL: Jane Marshall, Deputy 11 Director, Division of License Renewal, NRR.

12MR. ERLANGER: Craig Erlanger, Acting 13 Director for the Division of Fuel Cycle Safety 14 Safeguards and Environmental Review.

15 (Off microphone comments) 16 MR. BALAZIK: Okay. You want to start?

17MS. GAVRILAS: Yes, so we had what I would 18qualify as a productive meeting this morning. And I'm 19 going to ask the Northwest Medical Isotopes to bring 20 their own clarification.

21 Mike and Steve prepared a few summary 22 points of the meeting that I'll ask them to go 23through, a couple of action items. And then I know 24 that Bill would like to engage you in some 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 157discussions. And with that, I'm going to ask Mike to 1 summarize.

2MR. BALAZIK: You going to go through the 3 points, Steve? You have the points?

4 MR. LYNCH: Whatever you would like.

5 MR. BALAZIK: Yes.

6 MR. LYNCH: I can go through it.

7MS. GAVRILAS: One of you two needs to do 8 the summary of this morning, please, and the action 9 items. Thank you very much.

10MR. LYNCH: All right. So I guess for 11 everyone's benefit that's in here that was not here in 12the morning, we had two main objectives that we had 13 set out to accomplish as identified by Northwest, and 14 those were to talk about the licensing approach for 15the facility. And then the second item was to talk 16 about mechanisms to expedite the review of Northwest's 17 construction permit application.

18 For the first point, we reached agreement 19 and a shared understanding that there is additional 20 technical information that Northwest will need to 21 provide to meet the Part 70 requirements in 10 CFR. 22 Whether that's submitted as part of their 23 operating license or as a separate application is up 24to them, but we are in agreement that regardless of 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 158 how the information is packaged, we understand on both 1 sides what technical information needs to be provided.

2 Is that correct?

3 And then the second point for mechanisms 4 to expedite the review, we went over a number of items 5 that we can do on both sides to make sure that we 6 review their construction permit application as 7 expeditiously as possible.

8 One of the items we discussed were 9 approaches to request for additional information to 10 limit both the total number of RAIs that we asked and 11 the number of rounds that we go through.

12 Ways that we can address that are ensuring 13 that the NRC is clear in the questions that we ask and 14 making sure that we have phone calls with Northwest 15 when those RAIs are issued to make sure they 16 understand the question that we are asking.

17 And also when they are getting prepared to 18 submit their responses, to have additional calls.

19 That may take the form of a public meeting if we need 20 to discuss technical details, or it could be shorter 21 clarification calls to make sure that they're on the 22 right track.

23 Again, the goal of that is to make sure 24 that we have a shared understanding of the NRC's 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 159 expectations and what Northwest's understanding of our 1 expectations is. We also emphasize that quality and 2 completion of those RAIs is important as well.

3 This fed into a larger discussion of 4 appropriate methods of communication during the review 5process. We have already established weekly calls 6 following the docketing of the application that Mike 7 and others as needed sit on with Carolyn once a week 8 to discuss the status of the review and then the other 9administrative details as necessary. And that's 10 consistent with our practices for other reviews 11 throughout the agency.

12MR. DEAN: So how long has that been going 13 on? For how long?

14 MR. LYNCH: Since January 12th.

15 MR. DEAN: Okay, all right.

16MR. LYNCH: So right after we concepted 17 the review and everyone got back from the holidays.

18 MR. DEAN: Okay.

19MR. LYNCH: We discussed the importance of 20 staying up to date on schedule, both from the NRC's 21 perspective as we're doing our review to make sure we 22 communicate how we're progressing towards milestones, 23 and also to get updates from Northwest on 24 anticipations of when, you know, if they have any 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 160 delays on the current application, responses through 1 RAIs, and just updates of when they anticipate 2 submitting future applications such as their operating 3 license application.

4 We discussed, as far as the information at 5 Northwest provides what's the threshold of what's 6 acceptable to the NRC, we went there already following 7 our formatting content that I had provided in NUREG 8 1537 and the ISG augmenting NUREG 1537.

9 And as far as the threshold that we set 10 for the information that we're doing our review, we 11 told them that when we do our review we use our 12 standard review plan that is publically available, and 13 that is the threshold we set for the information that 14 we are looking for in their application.

15 And to maximize the efficiency of our 16 review, the clearer it is to us that they have 17 addressed the acceptance criteria in the standard 18 review plan, the easier it is for the NRC to move 19 forward quickly.

20MR. DEAN: Both for the Part 50 and the 21 Part 70 aspects?

22MR. LYNCH: Yes, yes. We discussed the 23 guidance for both aspects that they can use.

24 MR. DEAN: Okay.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 161MR. LYNCH: We also talked about the 1 importance of reducing administrative time for 2 processing on the NRC side and also preparation of 3documents on Northwest's side. The goal is through 4 our talks to make sure that there isn't significant 5 debt time where either side is sitting, not doing 6 anything and just waiting.

7 And this feeds into general program and 8 project management on both sides and making sure that 9 we are identifying clear goals towards working towards 10 the identified milestones that we have in the project.

11 And the last thing that we went over, or 12 I shouldn't say last thing, I could think of two more 13things. Looking at past precedents, we have examples 14of reviews we have done in the past, most recently 15 with SHINE, there are transcripts available from ACRS 16 meetings that they can look through as we go through 17ACRS to help improve their preparation for those 18 meetings.19 Also, they can get a sense from looking at 20 these applications for what the NRC has found 21 acceptable in the past and types of RAIs we've asked 22 in the past and what types of responses we're looking 23 for and similarity of reviews.

24 As we get ready for their operating 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 162 license application, one way we can get ready for that 1 is we explore the possibility of having pre-2 application meetings to discuss the technical problems 3 or issues that may come up that we need to explore 4 before the application is submitted that there may be 5 questions on.

6 And also with the current construction 7 permit application, we talked about efficiencies that 8 can be gained from maintaining that document up to 9 date as they respond to RAIs and information in their 10 current PSAR needs to be updated, that they can 11 provide updates to that.

12 At times it will work out with Mike, it 13 will make it easier for our reviewers to have a single 14 document to look at that has all of the updated and 15 completed information, and also as we go forward to 16 the ACRS and with the mandatory hearing.

17 We also discussed earlier today the status 18of our review and our plans going forward. So with 19 all of that, I think with that I think with those 20 topics, that addressed the second main point of 21 talking about ways that we could expedite the review.

22 I think that covers it for that second point.

23MR. FOWLER: You did a good job, thank 24 you.25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 163MR. LYNCH: And then between 1:30 and 2:00 1 we came up with a list of action items to take away to 2 come back to in the future. The first of these was 3 setting up a, exploring the possibility of setting up 4 standing public meetings.

5 And this, Mike and Northwest will work 6together on this to see if it's needed. But the idea 7 behind this is to cut down on some of that 8 administrative time.

9 If we see the need to discuss significant 10 technical information, most likely related to RAIs on 11 a regular basis, instead of noticing public meetings 12 every time we need to have one, we set up a frequency 13 maybe once a month, once every other month, something 14that's agreed upon between both parties. That was 15 identified as a topic worth exploring in the future to 16 see if it could help in the review.

17 The next action item we had was in a 18 future meeting discuss when the final design for 19Northwest will be provided to the NRC. This includes, 20 you know, the final design could be submitted as part 21 of the operating license application, or it could be 22 submitted while we are still reviewing the 23 construction permit.

24 And understanding Northwest's intent will 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 164help us in our preparations. And then on our side of 1that, we can discuss with them in the future the 2 impact of their decision to go forward one way or 3 another, without recommending a preference.

4 The third item that I had here was the NRC 5 could benefit also from understanding any additional 6 licensing actions that Northwest may request in the 7 future.8 This could be related to transportation of 9 materials, any exemptions that they foresee needing 10 for their current licensing requests or future 11licensing requests. Also, license amendments that 12 existing research reactors might need in order to 13 support the radiations of their manufacture targets.

14 Fourth item that we had as a take-away was 15 making sure that we have clear expectations on both 16sides. This has to do with, mostly with requests for 17 additional information.

18 Northwest would like to be able to review 19 drafts of the RAIs for potential proprietary 20information before they're issued. And also to the 21 extent practicable, we would like notifications of 22 when the RAIs are getting close to being issued so 23 that they can make sure that their resources are ready 24 to receive any begin working on responses to them.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 165 Also, Northwest offered that for future 1 public meetings, that we have it out in Missouri, that 2 the local government there is willing to work with us 3 in getting that set up in the future as well.

4 And I think the last thing, the last 5 action item I had on here was on both sides, and it's 6 kind of relates to everything else we've just been 7 talking about is just having clear communications on 8 both sides of schedule, NRC making sure that we 9 identify the milestones that we're working towards and 10 our progress towards that and Northwest, again letting 11 us know their schedule and any impacts they may have.

12 MR. DEAN: Okay, is that it?

13 MR. LYNCH: Yes.

14 MR. DEAN: Okay. Good. Sounds like you 15guys had a productive meeting. So appreciate you guys 16 coming here from Oregon? Both of you from Oregon?

17 MS. HAASS: The northwest.

18MR. DEAN: Northwest? Okay. Go Ducks.

19 No?20MR. FOWLER: Well, we have Ducks and 21 Beavers.22MR. DEAN: Okay, all right. Depends what 23 part.24 MS. HAASS: I'm a Husky.

25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 166 MR. DEAN: Okay, depends on what part of 1the state that you're from. Well, so I appreciate you 2guys coming in. And it sounds like it was very 3 productive and useful meeting.

4 I know that you all were here not too long 5 ago and had expressed some concerns with some of our 6 commissioners and some of our senior management about 7 the process and not having a good understanding of the 8 process.9 And so it sounds like, and I certainly 10 would be interested in your all's perspective that 11 today's meeting helped move us forward in terms of 12 establishing better communication and better 13 understanding of what you can expect from us, but also 14 things that we hope that we can engender from your 15 side of it because I view, personally I view this 16 process, and it's a big deal right, moly-99 is a big 17 deal for this country.

18 And so you guys are pursuing something 19 that is important to public health and safety which is 20 obviously the ultimate mission or objective of the 21 NRC, that we do it in a collaborative way and not in 22 any sort of adversarial way.

23 I know there's always just sort of dynamic 24 in terms of a licensee or an applicant and the NRC and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 167 we ask a bunch of questions, you got to give us a 1 bunch of answers.

2 But in reality, I think we're all striving 3 to get to the same point which is can we get licensed 4 for construction and utilization a facility that can 5 be useful in providing moly-99.

6 So in that regard, I think what we have is 7a very common end point. So I guess I would be 8 interested in your all's perspective in terms of how 9 you thought today's discussion went, were we able to 10 address perhaps some of the concerns you've had in the 11 past.12 And if there's still some open questions, 13 you know, Steve went through a list of action items, 14 but are there still some things that you all have in 15 your mind that are kind of open or areas that we ought 16 to consider.

17 Like, one thing I didn't hear in your 18 discussion was the benefit of, you know, sometimes 19 when we get an RAI process there's this kind of 20 throwing stuff over the transom and then you all 21 develop and throw it back over the transom.

22 And sometimes we can make better progress 23 if we do things like, well we call them audits, right, 24 but we actually either send people to wherever the 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 168 information is and have face to face meetings as 1 opposed to going into a sort of a writing campaign.

2 Is that something you guys talked about was the audit 3 process?4MR. LYNCH: We did not talk about that 5today. But we have had an audit on the environmental 6 side as they were preparing information.

7 MR. DEAN: Okay.

8MR. LYNCH: So we have gone through that.

9MS. HAASS: And we've had the discussions 10 in the past and we know that it's one of the tools we 11 can use to make things more efficient.

12 MR. DEAN: Okay. Okay, good. Okay, and 13 then the other one was I didn't hear anything about 14 would it be beneficial for example to set up an 15 electronic reading room where you guys have materials 16 that you developed that are accessible to our staff 17 through some sort of portal or whatever so there's 18 more ready actions instead of you guys having to mail 19 them.20MS. HAASS: Well, and we are setting that 21up. There's always technical difficulties because you 22 guys have some requirements and you know what they 23 are, you know, about the encryption and the passwords 24and this, that, and the other. And so those things 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 169 are getting set up.

1 MR. DEAN: Okay. I think we've had some 2 success where the licensee sort of maintains that and 3 then we just get a password for access and it helps 4 maybe avoid some of those, you know, red tape things 5 that we tend to have as a bureaucracy.

6 But anyway, so we certainly, that would be 7 something that could hopefully improve or increase 8 efficiency.

9 MS. HAASS: Well, and another thing that 10 could help efficiencies is I know we talked about it 11a bit offline just standing here. But, you know, some 12 granularity on how, what RAIs are going to be coming 13 because you're not going to throw all of them over at 14 once.15You may be doing them based on subject 16 matter areas and, you know, getting a better 17 granularity in a schedule like that because that helps 18 both your resources and ours and us to be more 19 efficient in responding as well.

20 MR. DEAN: So I was pleased to hear that 21you guys have set up weekly calls. So hopefully 22you're finding those beneficial. I know that we do in 23 terms of being able to ferret out those sort of 24 things.25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 170 And I don't know whether, have you guys 1 kind of developed sort of a standing agenda, or has it 2 kind of been sort of ad hoc? I would assume that 3 there's things that week to week that you're going to 4 want to talk about.

5MS. HAASS: Yes, there's definitely a 6standing agenda. But then, you know, you've got 7 things come on and off that agenda as well.

8MR. BALAZIK: And this is Mike Balazik.

9 And sometimes we'll share stuff earlier in the week 10 that is to be a great topic to have on that weekly 11 call so that we can take one level deeper into it if 12 it's just Kevin and I talking. Sometimes we'll move 13 stuff on a weekly call.

14MR. DEAN: And also to make sure we get 15 the right people there.

16 MR. BALAZIK: Correct.

17MR. DEAN: Okay, all right. So that's 18 good. I think that's a great initiative to do that.

19 So at least what I'm hearing was that it was a 20 constructive, worthwhile meeting, is that --

21MR. FOWLER: I do believe it was a very 22productive meeting. And for those of you who attended 23 our meeting about a month ago in the Executive 24 Director's office, we understand that the NRC has a 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 171 mission for public health and takes the production 1 capability this country for moly-99 very seriously.

2 We understand that, appreciate that, 3respect that. I hope that you all also understand 4 that we take our mission of providing that secure, 5 reliable supply of moly-99 in the United States 6extremely seriously. That was part of the intent with 7 the Executive Director's office when we were there.

8 We also wanted to communicate that while 9 we all know that this is a public health potential 10 issue, sometimes hearing directly from the feet on the 11 street, the constituents and our supporters and 12 investors are public healthcare institutions serving 13 tens of millions of people across the United States.

14 And so to hear directly from the CEOs of 15 those public health services organizations I think is 16 important to remind us of just how real the mission 17that we share collaboratively really is. It's 18 extremely important.

19 This meeting stemmed as a follow up to a 20 couple of outstanding items from the initial meeting, 21 the first being clarification on our licensing 22application submission process. And that one, declare 23 victory.24We understand it is in good shape. We 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 172 all, I think, are in agreement that we understand 1where to go from here. We will need to telegraph our 2approach so that the NRC can anticipate. But we're 3 all on common understanding of that first objective.

4 So declare success on that one.

5 The much broader one is how do we meet the 6 needs of this country in a timely fashion. And what 7 we achieved today was establishment of a very strong 8 framework that we now understand better how the 9 schedule of review is constructed and built within the 10 NRC.11 That helps tremendously because we can 12 look at the assumptions, we can compare the 13 assumptions, and we can begin to manage this as a 14project. It's likely, in fact it's assured, that 15 we'll need a number of follow up conversations to 16 translate that framework into a plan that can be 17 project managed, and we've left with a joint objective 18 to do exactly that.

19 And Steve did a great job of summarizing 20some of those actions. And so we can't yet close with 21 full success the second objective on accelerate the 22 schedule to degree possible.

23 I think we have a pathway to continue a 24 process to get to a mutually agreed schedule, one that 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 173we can both bring back to our supporters and manage 1 against with expectations, identify milestones, 2 identify where we've deviated from milestones, and 3 take remedial actions as appropriate.

4 And that, to me, is a successful day spent 5 here in the DC area.

6MR. DEAN: Well good, I'm pleased to hear 7that, Nick, in terms of your perspective on how the 8 meeting went because certainly this was one that I 9 felt was very important, you know, the fact that 10 Michele and I and Lawrence wanted to make sure that we 11 touched base with you all before you left to make sure 12 that the meeting met your objective was very important 13 to us.14 And so that gives me great confidence that 15 we did have a constructive and productive dialogue.

16 But we need to sustain that.

17 MR. FOWLER: Exactly right.

18 MR. DEAN: And I like some of the things 19 you guys have talked about in terms of potential 20 action items. I was interested a little bit more in 21 exploring the topic that Steve raised that when we 22 have meetings in Missouri and the engagement of the 23 local government.

24 What's the sort of the rationale, what are 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 174we trying to achieve with that. That's a good thing, 1 but I mean --

2MR. FOWLER: That was in specific 3 reference to any ongoing environmental public meeting 4 needs where we've had one meeting in Columbia already.

5 If there were needs for others, the City of Columbia 6 and the County of Boone County in Missouri have 7 offered any and all assistance to the NRC if any is 8 requested.

9 MR. DEAN: Okay.

10 MR. FOWLER: They stand ready to help.

11 MR. DEAN: Okay.

12MR. LYNCH: And this is consistent with 13 previous reviews, even for the SHINE review we've gone 14 out for the environmental meetings generally, send an 15 email to the city manager and county executives, let 16 them know we're coming, offer any government-17 government interaction they would like to better 18 understand our process and work our way forward.

19 MR. DEAN: Okay.

20 MR. LYNCH: So that's all consistent.

21 MR. DEAN: Okay. Good, okay. Good.

22 MS. HAASS: And there's also the ability 23 that they would help you coordinate to make things 24easier, you know, on you. They have the facilities 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 175 available.

1 MR. DEAN: That's great.

2MS. HAASS: And so, and they want to be 3 involved.4MR. DEAN: Super. Okay, that's wonderful.

5Okay, good. Okay. Anything for me that you would 6 like to convey beyond what you already have?

7MR. FOWLER: Well I think that again, 8we've had a successful meeting. I think in other 9 strategic partnerships that are collaborative in 10 business that I run, we have not only program 11 management at the level of checking all the boxes on 12 the program plan, we have a refreshment at this level 13 to ensure that both parties are in fact comfortable 14 with progress and resource assignments and strategic 15 alignment as we move forward.

16 Certainly it doesn't need to be a monthly 17 meeting at this level, but probably on a quarterly or 18 semi-annual basis it would make sense for us to touch 19 base at this level to ensure that we're both meeting 20 each other's expectations of moving forward.

21 MR. DEAN: Okay. And you're comfortable 22 with the 12 to 15 to 1 ratio of members of the NRC?

23 Is that okay? You're comfortable with that ratio?

24MR. FOWLER: Well, come out our way and 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 176 we'll reverse the ratio.

1MR. DEAN: Good, good. Well, anything 2 else that you would like to achieve today?

3 MS. GAVRILAS: No. I think we met their 4 objectives and we have a good meeting.

5MR. DEAN: Okay, good. Good. All right, 6 so who do I point to in terms of is it Mike is the 7 sort of individual that I want to point to as 8somebody, for SHINE I went to Steve a lot. So is 9 Mike?10MS. GAVRILAS: So that was one of the 11 issues we discussed that even though there are 12 multiple organizations involved in the review, there 13 will be one voice for the NRC and that voice is Mike.

14MR. DEAN: Okay, good. Okay, good.

15 Super. Okay, anything else? Excellent. Okay.

16MR. FOWLER: Finished the agenda on time.

17MR. DEAN: Safe travels. Safe travels 18 back.19MR. BALAZIK: This is Mike Balazik. I 20 just want to thank everybody for attending the meeting 21today. And we're going to close the bridge line.

22 Thank you.

23 (Whereupon, the meeting in the above-24 entitled matter was concluded at 2:58 p.m.)

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