ML16083A106

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

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

Text

Official Transcript of ProceedingsNUCLEAR REGULATORY COMMISSIONTitle:Meeting with Northwest Medical IsotopesDocket Number:Location:Rockville, MarylandDate:Thursday, February 18, 2016Work Order No.:NRC-2177Pages 1-176NEAL R. GROSS AND CO., INC.Court Reporters and Transcribers1323 Rhode Island Avenue, N.W.Washington, D.C. 20005(202) 234-4433 1UNITED STATES OF AMERICA1NUCLEAR REGULATORY COMMISSION2+ + + + +3PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC4+ + + + +5THURSDAY,6FEBRUARY 18, 20167+ + + + +8ROCKVILLE, MARYLAND9+ + + + +10The Public Meeting commenced in Room O-1116B4, One White Flint North, 11555 Rockville Pike, at128:30 a.m., Mike Balazik, Project Manager, presiding.1314NRC STAFF PRESENT:15LAWRENCE KOKAJKO, Director, Division of Policy and 16Rulemaking, Office of Nuclear Reactor 17Regulation18WILLIAM DEAN, Regional Administrator, Region I 19CRAIG ERLANGER, Acting Director, Division of Fuel 20Cycle Safety, Safeguards, & Environmental 21Review, Office of Nuclear Material Safety and 22Safeguards 23MICHELE EVANS, Deputy Director, Office of Nuclear 24Reactor Regulation25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 2JANE MARSHALL, Deputy Director, Division of License 1Renewal, Office of Nuclear Reactor Regulation2MICHAEL BALAZIK, Project Manager, Division of Policy 3and Rulemaking, Office of Nuclear Reactor 4Regulation5ALEXANDER ADAMS, Chief, Research and Test Reactors 6Licensing, Office of Nuclear Reactor 7Regulation8MIRELA GAVRILAS, Deputy Director, Division of Policy 9and Rulemaking, Office of Nuclear Reactor 10Regulation11SHANA HELTON, Acting Deputy Division Director, 12Division of Fuel Cycle Safety, Safeguards & 13Environmental Review, Office of Nuclear 14Material Safety and Safeguards 15ROBERT JOHNSON, Chief, Fuel Manufacturing Branch, 16Office of Nuclear Material Safety and 17Safeguards 18STEVE LYNCH, Project Manager, Research and Test 19Reactors Licensing Branch, Office of Nuclear 20Reactor Regulation21NANCY MARTINEZ, Environmental Project Manager, 22Office of Nuclear Reactor Regulation 2324 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 3DAVE TIKTINSKY, Project Manager, Fuel Manufacturing1Branch, Office of Nuclear Material Safety and 2Safeguards34ALSO PRESENT:5NICHOLAS FOWLER, Chief Executive Officer, NWMI6CAROLYN HAASS, Chief Operating Officer, NWMI78 910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 4T-A-B-L-E O-F C-O-N-T-E-N-T-S1Page2Opening Remarks by NRC Staff3Michael Balazik..............64Mirela Gavrilas..............135Shana Helton...............146Opening Remarks by Northwest Medical Isotopes7Nicholas Fowler..............158NRC Licensing Processes9 10 CFR Part 50, General10Steve Lynch................2011 10 CFR Part 51, Environmental12Nancy Martinez..............3613 10 CFR Part 50, Construction & Operating License14Steve Lynch................4215NRC Licensing Process, Part 7016Dave Tiktinsky..............9017Licensing Review Request (NWMI licensing request and18NRC understanding of request - NRC/NWMI)19Al Adams................1132021 22 23 24 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 5Communications (NRC/NWMI)1Michael Balazik.............1262Steve Lynch...............1303Al Adams................1344Dave Tiktinsky.............1355NWMI Topics for Discussion..........1416Closing Remarks/Summary............1557Adjourned...................1768910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 6P-R-O-C-E-E-D-I-N-G-S1(8:33 a.m.)2MR. BALAZIK: All right, good morning. 3I'd like welcome everyone in attendance today. My4name is Mike Balazik. I'm a project manager in the5Division of Policy and Rulemaking at the NRC.6Northwest Medical Isotopes has agreed to7meet with the NRC staff today to discuss licensing for8their radio isotope facility.9This is a Category 1 public meeting10conducted in accordance with the Commission's Police11Statement on enhancing public participation in NRC12meetings. As such is intended to be a dialogue13between the NRC and Northwest Medical Isotopes14concerning topics related to licensing in Northwest15Medical Isotope facility project.16The public in invited to observe the17meeting and will have the opportunity to communicate18with the NRC staff after the business portion of the19meeting, but before the meeting is adjourned. 20Northwest may respond to comments or questions from21the public but is not obligated to do so.22When we go through the introductions I ask23everybody identify yourself and your affiliation. 24There's a sign-in sheet that may be moving around the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 7room right now. I ask everyone sign in. Yes, thank1you.2If you wish to provide any comments on the3meeting, I can provide you a meeting feedback form. 4Or you can also go to the public meeting cite and do5it electronically.6This meeting is scheduled to last till7approximately 3:00 p.m. I'd like to emphasize that8this meeting is primary for the NRC to discuss general9licensing processes and reviews, the NRC regulations10and guidance with the Northwest. There are no11regulatory decisions will be made at this meeting.12Also, as a reminder, this meeting is being13transcribed today. And for everybody on the phone,14the slide presentation is available. It's publically15available. And I'm going to provide the NO number16right now for everyone. The number is ML16048A, as in17Alpha, 554.18Does anybody on the phone need that19repeated? All right, I'm not hearing any.20(Off record comment)21MR. BALAZIK: All right, I'll continue on. 22A meeting summary will be made publically available23within 30 days of this meeting.24Before we begin, a couple of items I'd25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 8like to mention. First of all, please limit1interruptions. Silence your cell phone and please2keep side conversations to a minimum.3I ask you speak one at a time. And4individuals on the phone, please mute your phone5unless you're going to provide any comment.6Also, please identify yourself when you7speak so people on the phone knows who's speaking. 8And again, submit any questions or comments to me at9mfb@nrc.gov.10Next I'd like to remind you that you're11within a NRC controlled space. Should there be an12emergency all occupants should begin to calmly13evacuate using the nearest stairwell to exit the14building.15All visitors will be escorted by the NRC16staff. Disables persons, who due to health reasons17feel they cannot safety walk down the stairs to18evacuate, may use the elevators. Exit through the19nearest door and then go to the pause area in front of20One White Flint and report their presence with the21guard.22So you experience, observe anyone with a23life threatening medical complaint while evacuating,24call 911 and report your location and nature of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 9emergency.1Also, if you need to use the restroom,2you'll need to be escorted.3All right. So let's now run though4introductions. I'd ask everyone to speak loudly so5people on the phone can here you. And let's start6around the table.7As I said earlier, my name is Mike8Balazik. I'm a Project Manager in Division of Policy9and Rulemaking.10MS. MARTINEZ: Good morning. I'm Nancy11Martinez, NRC Environmental Project Manager.12MS. GAVRILAS: Mirela Gavrilas, Deputy13Director, Division of Policy and Rulemaking in NRR at14the NRC.15MR. LYNCH: This is Steve Lynch. I'm a16Project Manager with Research and Test Reactors.17And real quick, before we go on with the18introductions, if you are participating on the phone,19could you please put your phone on mute? We're20getting a lot of feedback in the room here. Thank21you.22MR. ADAMS: Al Adams, Chief of Research23and Test Reactor Licensing, NRC.24MR. TIKTINSKY: Dave Tiktinsky, Project25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 10Manager of the Field Manufacturing Branch in Office of1Nuclear Material Safety and Safeguards.2MR. JOHNSON: Good morning. Robert3Johnson, Fuel Manufacturing Branch Chief, NMSS.4MS. HELTON: Shana Helton, Acting Deputy5Division Director at Fuel Cycle NMSS.6MR. FOWLER: Nick Fowler, the Chief7Executive Officer of Northwest Medical Isotopes.8MS. HAASS: Carolyn Haass, Chief Operating9Office, Northwest Medical Isotopes.10MS. KEIM: Andrea Keim, Vendor Inspection11and Quality Assurance, NRR.12MR. MATULA: Tom Matula, NMSS, Project13Manager.14MR. MORRISSEY: Kevin Morrissey, Fuel15Cycle Review.16MS. ADAMS: Mary Adams, Fuel Cycle Safety17and Environmental Review.18MS. LONDON: Lisa London, Office of19General Counsel.20MS. BIELECKI: Jessica Bielecki, Office of21General Counsel.22MR. LINDELL: Joseph Lindell, Office of23General Counsel.24MS. KANATAS: Catherine Kanatas, Office of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 11General Counsel.1MS. YOUNG: Mitzi Young, Office of the2General Counsel.3MS. TRAN: Linh Tran, Research and Test4Reactor Licensing Branch, NRC.5MR. ALLEN: Eben Allen, Research and Test6Reactor, Project Manager.7MR. BALAZIK: This is Mike Balazik, please8mute your phones. Somebody's got an open line and9they're speaking and we're hearing you in the room.10MR. LYNCH: Star 6.11MR. DANNA: Jim Danna, NRR, Division of12License Renewal.13MR. MILLER: Chris Miller, Office of14Nuclear Reactor Regulation. And I'm the Director of15the Division of License Group.16MR. ISAAC: Patrick Isaac, Research17Reactor Oversight Branch.18MR. BALAZIK: All right, this is Mike19Balazik again. Let's go to the phone line. I ask20individuals to identify themselves.21MR. RODRIGUEZ: Michael Rodriguez, NRC,22NSIR EP.23MR. FLAGG: Michael Flagg, University of24Missouri Research Reactor.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 12MS. MCCULLOUGH: Kara McCullough, NSIR,1NRLB.2MR. BERICK: Dave Berick with Senator Ron3W.4MS. RIVERA: Alison Rivera, NSIR EP.5MS. BANERJEE: Good morning. Maitri6Banerjee, ACRS Staff.7MS. WEIL: Jenny Weil, Congressional8Affairs.9MS. FRAZIER: Andy Frazier, Region III10Office.11MS. MOSER: Michelle Moser, Environmental12Energy Staff.13MR. BARTELME: Jeff Bartelme, SHINE14Medical Technologies.15MR. NAQUIN: Ty Naquin, NMSS, Fuel16Manufacturing Branch.17MR. TEAL: Charles Teal, NSIR Fuel Cycle18Transportation Security Branch.19MR. FOLK: Kevin Folk, NRC Environmental20Staff.21MR. WEBER: Carl Weber, NRC, Office of New22Reactors.23MR. BALAZIK: Is there anybody else on the24phone that wishes to identify themselves? Okay, I'm25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 13hearing none.1So now I'd like to turn it over to Mirela,2who would like to provide some opening remarks.3MS. GAVRILAS: Thank you, Mike. Welcome4everyone. I want to start out with a very high level5statement which is, that we, the Agency, recognize the6importance of establishing a reliable domestic supply7of molybdenum-99.8And as such, we recognize our role to9support that national effort. So you will see, you10will hear today about what we do and how we do it and11why we do it.12And you'll also hear, you see already that13the room is filled with technical experts and with14regulatory experts who are here to answer all your15questions. Because the main objective of this meeting16is to obtain clarity in our communications.17It is very important to us that we hear18each other correctly. Because we realize that every19time we take time out to clear out misunderstanding,20we spent resources and time that would be better spent21moving the review and the effort forward.22So our main objective today is basically23to discuss the topics that we agreed with Northwest24Medical, should be discussed today. And we want to25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 14have open dialogue. So please ask questions at any1time.2Again, we have the technical and the3regulatory experts in the room to address your4questions. So we want to make sure that at the end of5the meeting, we're aligned in terms of our6understanding of where we are in terms of the review7of the construction permit that's in front of us now,8as well we the preview of the operating license that9is still to come.10So with that, I'm going to pass it to11Shana who is going to give a couple of additional12opening remarks.13MS. HELTON: Thanks, Mirela. I agree with14Mirela's points. I can't emphasize enough the need to15obtain clarity on both sides, so that we can have an16efficient, effective licensing path forward.17And to that end, I just want to say, that18while multiple offices are involved with this review,19we do act as one NRC. You will hear from us with one20voice.21Mike Balazik will be your primary point of22contact. So you don't have to worry about trying to23correlate between different offices.24And just as we go through this, one point25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 15that I wanted to emphasize is that for each1application that we receive as an Agency, not just in2this area of medical isotopes, we review each3application based on its merits.4So really we need to look at what's before5us today. And as we go through the construction6permit, that will be one aspect of the review.7One goal, on our end, is to really gain8clarity on the nature of any of your future9submittals, since you've indicated that some of your10activities would be regulated under Part 70 and under11Part 30. So I look forward to learning more about12that path forward as well.13So with that, you know, I just look14forward to having a good meeting. Thank you for15coming here today. And for everybody on the phone.16MR. BALAZIK: This is Mike Balazik. Thank17you, Shana. Now I'll turn it over to Northwest18Medical Isotopes for some opening remarks.19MR. FOWLER: Well, and I would add my20thanks to everyone that's assembled here. In that we21all understand the importance of serving a reliable22and secure supply within the United States for moly-2399.24And we met with the executive director and25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 16his direct staff and a number of folks who are in this1room a month ago. And we believe, Northwest Medical2Isotopes believe, it was an excellent conversation. 3Part of a long-term relationship building exercise to4make these conversations as productive as possible.5We invited with us, a couple of people to6provide perspective. One of whom was the chief7executive officer of a leading healthcare services8provider in the United States.9And we all recognize the need for this10reliable supply of moly in the United States. But11sometimes hearing it from a healthcare services12provider that's responsible for millions of people,13who can provide that direct testimony of what it means14when there are shortages, is important. And we15thought that important to provide that direct16perspective into the executive meeting a month ago.17We also invited Mallinckrodt to speak on18the state of the supply chain. And what is coming19forward in the near future and the potential fragility20of that supply chain that really puts a point on why21these activities that are before the NRC are so22important.23We then had a fruitful discussion on two24questions that Northwest Medical Isotopes had25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 17specifically. And we hope that this meeting today1directly addresses those two questions as follow up to2that meeting.3The first had to do with the licensing4approach as our activities do incorporate both Part 505and Part 70 activity in our intended operations.6And the other was recognizing the need for7this domestic supply, exploring mechanisms by which8the review schedule can be accelerated, expedited,9done in the most productive fashion possible.10And we are committed to not only11understanding the process of the NRC and being12extremely responsive to that process, but also doing13everything we can possibly do to make that review as14expeditious as possible. And we hope to have that15kind of conversation today to understand how we might16work better together to get the review done and as17quickly as possible, without compromising our combined18committee to public safety, as well as public health.19And so I did have the opportunity on the20nine hour trip yesterday, in the care of one of our21major airlines, to review the materials that Mike had22provided to Carolyn in advance.23And in the interest of everybody's time24assembled, I think the package is great from an25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 18educational standpoint. I think we understand largely1the background.2And so perhaps going through the general3information as quickly as possible, and getting4specifically more to those two follow up items, could5save us all some time. Because we have reviewed all6the guidance from the NRC. We've reviewed the general7information.8And so getting quickly to the areas of9combined interest is certainly our objective here. 10So, Michael, thank you very much for providing the11materials early.12And with that, I'd like to turn it back to13the NRC to begin this, what we all hope, to be a very14productive meeting.15MR. BALAZIK: Thank you, Nicholas, I16appreciate that.17MS. GAVRILAS: So just one comment. The18slides that you have, we really appreciated the fact19that you reviewed them before we're going to talk20about them.21They're intended to engage you in dialogue22with us. They're intended to basically, we're talking23in general, and you may want to take the opportunity24to ask, how does this impact us.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 19What we're trying to understand is, not1just what your questions are, but why you asked those2questions. Because we want to make sure that we're3answering, not just the words, but the intent of what4you're trying to find out.5So again, thank you for going through6them, this is great. It seldomly happens. And we'll7just use them as context for the rest of the8discussion. So please, at any time, just stop us and9talk to us about everything. Thanks.10MR. BALAZIK: All right, this is Mike11Balazik again. First of all, for transcription12purposes, please identify yourself prior to speaking. 13And let's start the presentation.14One item that I'd like to add is that no15proprietary materials planned to be discussed by this16staff during this meeting. However, if Northwest17Medical Isotopes believes that we are starting to move18in that direction, please let us know so that we can19cut off the discussion right there. So thank you.20All right, these -- here's the staff21that's presenting today. Earlier we've all identified22ourselves so we'll go through these slides real quick.23Basically this is the meeting purpose. 24Here's some of the main topics we want to cover today. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 20Just provide a general overview of the NRC, oops, I'm1sorry. It skipped one on me.2Provide an overview of NRC licensing3processes, provide an overview of NRC regulations and4guidance for construction permit operating license and5a Part 70 license, as well as a 30 license. Discuss6review timeline. Provide status of the construction7permit application review and discuss communications. 8Okay?9And next we'll go into the licensing.10MR. LYNCH: Sure. This is Steve Lynch. 11And just to give myself a little bit more of an12introduction.13For those who don't know, I was involved14with the SHINE review and was the lead projector15manager for that. So I'm helping out with the16Northwest review to provide insights and input to help17gain efficiencies and lessons learned from previous18reviews that we've done. And apply them.19And that's what we try doing at the NRC. 20Is we've done something before, hopefully the next21time we do it we can apply the lessons learned from22before.23So to get started with this introduction24here, these considerations are for both the applicant25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 21and the NRC. We want to emphasis that where we pick1the licensing process from the regulations is driven2by the technology that's put in front of us.3And especially with the medical isotope4facilities. Some of the considerations that we look5at are, how much material are you going to have, what6types of material will be onsite.7That will help determine where you fall in8the regulations, the activities that you're actually9going to be performing with this material.10Are you going to be making targets, are11you going to be irradiating targets, will you be12processing targets. How will you be irradiating your13targets. Will you be using a nuclear reactor. Will14an accelerator be involved.15Then we also look at the, how you're going16to be processing the targets afterwards. And the17bigger driver for licensing regimes there is, looking18at the batch size.19As I'm sure you're very well aware, if20you're processing batches of greater than 100 grams of21special nuclear material, that will put that activity22into the Part 50 licensing process.23And then one of the other considerations24we look at is, will you be using new or existing25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 22facilities. And as I understand with Northwest, it1will be a mixture of both. Using existing research2reactors as well as constructing a new facility for3processing.4Next slide. So once we've looked at all5the technology and how you're going to be using the6material, the next step is to try putting it into the7different boxes we have in our regulations.8These are not all of the regulations that9you need to follow in order to get a license. But10these, in terms of the application that you provided,11are some of the main technological boxes that we'll be12looking at in terms of licensing the production13facility in Part 50.14The special nuclear material will be15looked at under Part 70. The moly that's produced16we'll be looking at under Part 30.17And then with all of this, we'll be18looking at the environmental impacts of these actions19and how the material will be used.20Next slide. So we're going to spend today21highlighting some of the different processes that we22use from that previous slide. Especially focusing on23Part 50, for the production facility, Part 70, for24material. And then also Part 51 for the environmental25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 23review process.1And we just kind of want to step through2these processes to see if you have any questions about3how we are conducting the review of the application4that you've provided us.5So we'll get started with an introduction6to how we're looking to have a Part 50. In order to7go through the Part 50 and licensing process, there8are two licenses that you will need to apply for and9get from the NRC in order to operate your facility.10And that's a construction permit, which11you have applied for, and an operating license that we12will look forward to reviewing, if you choose to13submit one.14The main components of the construction15permit are the environmental report and the16preliminary safety analysis report. You've submitted17both of those, so you're familiar with their content.18And then for the operating license19application, we'll be looking at your final safety20analysis report, which includes more information, and21was in your PSAR. Including your plans for operation,22handling emergencies and your technical23specifications.24Another main component of the operating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 24license application will be the Physical Security1Plan.2Our commitment to doing these reviews, for3both the construction permit and the operating4license, is to finish these reviews within a year and5a half to two years from docketing the application.6Based on the experience that we have7recently with applications like this, we believe that8we can meet that review schedule.9Yes, we're going to go into more detail10about ways that we can, that factors that may11accelerate or hinder our ability to meet this.12Next slide. So today we'll focus mostly13on the regulations and licensing surrounding14construction permits. Since that's the application15that we have in-house.16If you would like to gain better17understanding of the operating license review process,18we can certainly discuss that in a future meeting.19For here, I wanted to highlight some of20the more important regulations concerning the21construction permit. This is highlighting the main,22you know, 50.22 puts you into the realm of the23commercial facility under the Atomic Energy Act. 24That's Section 103.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 25And as I'm sure you're aware, this is1slightly different than most of the other non-power2facilities that we license under Part 50. Those are3generally research reactors that are non-commercial4facilities.5And the main difference that we see there6is that there will be a mandatory hearing on your7application. And there will be a review by the ACRS8as well.9The other, some of the other things that10you're aware of under 50.30, you're to submit an11environmental report, which you have done. And submit12a preliminary safety analysis report under 50.34, also13what you have done.14And then some of the other important15regulations that you address in your accident analysis16are meeting both occupational and public dose17requirements under Part 20.18All right, then after we finished our19review of your application, what the NRC is fighting20to come to a conclusion is, can you construct your21facility as described in your PSAR?22And what we're looking at there are these23regulations that I have listed at the end there. 2450.35, which I'll go into more detail on on the next25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 26slide, as far as the findings that the commission1needs to make in order to issue a construction permit. 2And those are supported also by the findings that are3in 50.40, 50.42 and 50.50.4Next slide. So as the NRC evaluates your5application, these are the primary four findings that6we are looking to make, based on the information that7you have provided.8We'll look at, to see, have you provided9the proposed facility design. And the emphasis here10is, what we're looking at for is, have you given us11your principle design criteria in this first bullet.12As you're aware, 50.34(a) does require13that you describe your principle design criteria. 14Unlike nuclear power reactors, the principle design15criteria are not enumerated in Appendix A of Part 50. 16And that you are left to propose your own design17criteria per your facility in this case.18We also recognize that we are being19provided a preliminary design. And as such, there may20be information that you have not provided at this21time.22We're looking to make the conclusion that23the information you have chosen to provide at a later24date is acceptable, but we don't need it at this time25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 27in order to establish a preliminary design.1Something else, 50.34(a)(8) allows ongoing2research and development through construction. For3those areas that you've identified that you have4ongoing research and development, we'll be looking to5see that you have a research and development program6developed and setup in order to resolve any safety7questions associated with those items.8And then all this comes down to, that we9need reasonable assurance, that prior to the10completion of construction, any safety questions that11are opened, will be resolved in the interest of public12health and safety.13Next slide. So this slide, what I wanted14to emphasize is the difference between the15determinations that we're making at the construction16stage and at the operating license stage.17At the construction stage, we're18essentially only -- we're allowing you to go forward19and construct. You've given us enough information for20us to say, go ahead and get started.21In contrast, when we issue an operating22license, this is when we say that, based on the final23design of the facility, that we believe it can be24operated safety. So I just wanted to emphasize the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 28difference in the emphasis that we place in those two1determinations.2Next slide. So I'm hoping this slide3helps partially answer one of your questions that you4had about the licensing process and how we look at5your applications and how you can submit them. And6we'll go into some more detail on this when we get7specific with your application.8But both the Atomic Energy Act and the9regulations allow for an applicant to combine10applications. And this is common.11There's, and mostly we'll see this with12the operating license application. In order for13reactors to operate, they will also require a Part 7014license in order to possess and use material on their15site.16And then following that up, the commission17does combine those licenses. So you see, and Al will18show you an example of that later today.19When reactors are issued licenses, there20is typically a Part 70 license. And the Part 3021license, and sometimes the Part 40 license that are22combined together in that, is on a single piece of23paper and a single license.24So we are --25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 29MR. FOWLER: Can I ask a question at this1point?2MR. LYNCH: Yes.3MR. FOWLER: At the executive director4meeting, Mirela, I believe you did a, at least you5helped me, and I'll use the, I could use inappropriate6terms in the regulatory environment because it's not7an environment that I deal with every day, but I8understood from your presentation, in that meeting,9that we had the choice. That we could submit a10separate Part 70 license or we could submit, under the11Part 50 umbrella, the Part 70 requirements with the12important caveat that the Part 70 information, at that13point of submission, needed to be final because it was14a one-step process.15And so I understood our follow up to be16within one week of that meeting, to confirm that17understanding to us that we had that option, between18those two choices. And, so I think in the interest of19time, if we could simply confirm that, that our20understanding is compatible with your understanding,21I think we're all set.22MS. GAVRILAS: What I said at the meeting23is still what our position is. And we'll walk you24through the slides.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 30This just helps explain the details. The1bottom line is, we look at your activities from a2safety perspective. And the security perspective.3So as long as we -- and our rules and our4guidance help us know what we need to evaluate in5those activities.6So whether the description of how you make7your safety case comes on one piece of paper or on two8pieces of paper, is not that important. In the end9we're going give you one license that captures all of10those activities.11But the review is going to be, we're going12to look at every safety component that we need to and13every security component of all the activities that14you are proposing.15So in other words, it doesn't matter how16the information comes in, the regulation is designed17to allow us to combine that information into one18license. And the regulation does allow us to19basically eliminate repetition.20So if you provided something in one21context, you don't need to resubmit that information,22because you do get credit for it under the activity. 23If the activity was described on one piece of paper,24you get credit for it. You don't need to describe it25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 31again.1MS. HELTON: Mirela, I agree. I just want2to make sure that it's clear that the packaging is up3to you. How you package it all together, multi4submissions, a single submission.5What needs to be clear, in your submission6or submittals, however you decide to do it is, what7regulations you're seeking to comply with. And then8you also have to fully demonstrate your compliance9with those regulations.10So it just has, however you do your11packaging, it has to be very clear that if you intend12for this information to satisfy Part 70, subpart (h),13or whatever you're going to do, that you have to very14explicitly.15That will help our review greatly if you16very explicitly say, this is the information that17complies part umptysquat. But, you know, we can't18identify that for you, you have to identify what parts19of the regulation you need to comply with, and then20you have to demonstrate how you comply.21MS. GAVRILAS: And to add to what Shana is22saying, you can cross reference in all of your23document that you submitted.24MS. HELTON: Right.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 32MS. GAVRILAS: And right away, that adds1to the case that I'm trying to make in this piece of2paper.3MR. FOWLER: So very simplistically, from4my standpoint, again, because I'm not schooled in the5art of regulatory review, is the final Part 706information, we can include, either in our operating7license under Part 50 application or as a separate8Part 70 document, but we need to be clear about what9we're submitting under which format.10MS. HELTON: Right.11MR. FOWLER: So if I have that very high12level kind of understanding, that will put it in my13brain, Carolyn will take care of the details. But at14least now I have it in my brain that the Part 70 is15either under an operating license or under a separate16Part 70 submission.17MR. LYNCH: Yes. And I think what's most18important there is, we're looking to make our safety19determination based on technical information that you20provide.21Whether it's Part 50 or Part 70, we still22have to say, we have technical requirements that we're23trying to make to justify safety. So we're looking24for technical information.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 33And when we have all that technical1information, we can figure out which box, you know,2will it be a full, will it be Part 50 with Part 70 as3part of that or separately. But we will evaluate that4based on the request that you ask of us.5MS. HAAS: We understand the safety6aspect. I mean Nick is just trying to bring it up --7MR. FOWLER: Yes.8MS. HAAS: -- because it's based on9conversations we've had over the last two or three10years and it got modified within your organization. 11So we just wanted to make sure that we understood it,12and we do. So thank you for the input and we'll move13on.14MS. GAVRILAS: You know, we start every15public meeting with a disclaimer, which is, we're not16going to reach regulatory decisions here and there's17a reason for that.18Everything that the staff reviews needs to19be on the docket. I mean that's the tentative of how20we operate.21So we have dialogue here. So right now,22what we have for review in front of us and what we can23be very specific on, at least the portions that we've24reviewed, is the construction permit. The Part 5025NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 34construction permit.1Anything else is in pre-application space. 2If that makes sense?3So if there is -- if we're sometimes4tentative or give you our best opinion, we will5clarify. That opinion will become definitive, once we6have an application in front of us.7It's worth repeating because, again, in8the absence of information, all we can do is say what9the most likely path is.10MR. LYNCH: Okay. Next slide. So what11we're going to transition to now is talking a little12bit more about the actual review process for the13construction permit. And we'll get into timelines and14what our expectations are for the review that we have15ahead of us.16So to introduce this, this is just kind of17a high level flow chart to highlight the main pieces18of the construction permit review. We have two19parallel reviews that we'll be going on.20And this is our safety review of your21preliminary safety analysis report and the22environmental review of your environmental report.23The results of each of these reviews will24feed into a number of things that will lead ultimately25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 35to the commission's decision to either grant or deny1your request for a permit.2The review, the output of that will be the3safety evaluation report prepared by the staff. That4will be reviewed by the ACRS.5And as part of their independent review,6it will also be considered by the commission and the7mandatory hearing.8There's also a possibility that there9could be contentions filed as a result of this. And10we'll talk a little bit more about that in a few11slides, but that's another step that could be in this12process.13The environmental review will also be, the14environmental impact statement that's being prepared,15will also be considered by the commission and its16decision to grant or deny the construction permit.17So right now I'm going to turn the18presentation over the Nancy Martinez, the project19manager leading the review of your environmental20report. And she's going to talk through some of the21specifics of the environmental review process and the22status of their review.23MS. MARTINEZ: Thank you, Steve. As Steve24mentioned, I'm the environmental project manager for25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 36the application. And I'm going to discuss the1environmental review process.2The environmental review is going to be3performed in accordance with the National4Environmental Policy Act of 1969. Commonly known as5NEPA.6NEPA requires fellow agencies to follow a7systematic approach in evaluating the potential8environmental impacts of the proposed action and to9assess the alternatives to those actions. The NEPA10process involves public participation and disclosure.11NRC's environmental regulations12implementing NEPA are contained in 10 CFR Part 51.13Slide 17 please. This slide presents an14overview on the steps that lead to the environmental15review process.16When an application is submitted to the17NRC, the NRC conducts an acceptance review. And an18acceptance review determines if the application has19sufficient information for the staff to conduct its20technical review.21If the application is accepted, the NRC22staff conducts a NEPA document determination. And23that is to whether develop and prepare an24environmental assessment or an environmental impact25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 37statement.1I will discuss in later slides, for the2Northwest application, the staff determined to prepare3an environmental impact statement. Once the NEPA4determination is made, the environmental review5process is conducted in accordance with 10 CFR Part651.7Slide 18 please. This slide presents an8overview for NRC's environmental process. 9Specifically for the environmental impact statement.10The environment review for an EIS begins11with the scoping process. Which includes a public12meeting.13Scoping is a process by which the NRC14staff identifies a specific impact and significant15issues to be considered in preparation of the16environmental impact statement.17Following the scoping process, the NRC18staff will perform its environmental analysis, which19will consist in part, of issuing request for20additional information to the applicant and preparing21the draft EIS.22The draft EIS is issued for public23comment. Once comments are received on the draft, the24NRC staff will consider those comments and issue its25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 38final environmental impact statement.1Slide 19 please. The environmental review2for the environmental impact statement will take 18 to322 months. This slide provides a detailed breakdown4of the process and timeframes.5As I previously mentioned, the6environmental review will begin with the scoping7process. Which for Northwest consisted of a 45 day8scoping period and a public meeting.9After the scoping period ends, the staff10develops a scoping summary report that addresses11public comments that were received during the scoping12period. This takes a minimum of 90 days and depends13on the number of comments that were received during14the scoping period.15The environmental analysis, in part, will16consist of developing and issuing a request for17additional information. Each round of RAIs will take18approximately 90 days.19And this will consist of developing and20issuing the RAIs, a 30 day response period and then21the staff reviewing the responses for clarity and22adequacy. The number of RAI rounds will depend on the23quality of RAI responses and the application.24Information from the applicant's report,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 39RAI responses, the scoping process, coordination with1other federal, state, tribal and local agencies, as2well as the staff's independent research, will be used3to draft the EIS.4When the draft EIS is published, it will5be made publically available for review and comment6for a 45 day period, in accordance with our7regulations. The comment period will include a public8meeting.9After the draft EIS comment period, the10staff will respond to comments provided on the draft11EIS and update the EIS as necessary. And this can12take approximately 120 to 150 days. And depends on13the number of comments and also the necessary EIS14updates. The final EIS is then issued.15Slide 20 please. The staff will perform16its environmental review in accordance with 10 CFR17Part 51. And will also use Interim Staff Guidance18augmenting NUREG-1537.19Slide 21 please. On February 5th, 2015,20Northwest resubmitted Part 1 of its construction21permit application. The public notice of receipt and22availability was issued on April 21st, 2015.23The NRC staff conducted an acceptance24review of the Northwest environment report, Chapter 1925NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 40of the application, in accordance with 10 CFR Part 51,1which identifies the information that shall be2contained in the applicant's environmental report.3An acceptance review is a completance4review that determines if the application has5sufficient information for the NRC staff to begin its6technical review.7Part 1 of the Northwest application was8accepted and the notice of acceptance was issued on9June 8th, 2015.10Slide 22. In accordance with 10 CFR1151.25, the staff determined whether to prepare an12environmental assessment or an environmental impact13statement.14Pursuant to 10 CFR 51.20(a)(2), the staff15determined that an EIS should be developed for the16proposed action. This determination was based on17operation of the proposed Northwest facility.18Connected action to the issuance of a19construction permit, consisting of target fabrication20and scrap recovery. A process similar to the process21used by field fabrication facilities, for which an EIS22is required under 10 CFR 51.20(b)(7).23Slide 23 please. The environmental review24will consider the impacts of construction, operation25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 41and decommissioning of the Northwest facility. We1will also consider the impacts of alternatives to the2proposed action, including alternative sites,3alternative technologies and the impacts of not4issuing a construction permit.5The environmental impact statement will6also consider the impacts from irradiation services7provided by the research and test reactors. Which is8a connected action to the proposed action.9Ultimately, the purpose of the10environmental review is to take a detailed hard look11at the environmental impacts of the proposed Northwest12facility. And after balancing the benefits versus the13cost or impacts of the proposed project, make a14recommendation to the commission on whether or not to15issue a construction permit.16Slide 24. The Northwest environmental17scoping period ended January 4th, 2016. The staff is18currently developing the scoping summary report and19responding to comments.20Two rounds of RAIs have been issued. The21first on November 2nd. Northwest responded to those22RAIs on December 3rd. The staff reviewed the23responses and had some follow ups. And those RAIs24were issued on January 19.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 42NRC anticipates that the draft EIS will be1issued on October 2016 and that the final EIS will be2issued on May 2017. And this is based on the3timeframes in the slide that I have provided earlier. 4And is keep within the 18 to 22 month schedule.5And that concludes my presentation on6environmental review.7MR. LYNCH: All right, next slide please. 8For those on the phone, this is Steve Lynch again. 9And I'm going to talk a little bit about the10construction permit safety review process.11Briefly touching on the content of the12PSAR in a little bit more detail, as well as going13through some of the assumptions that we made and14coming up with this 18 to 24 month timeline for our15review schedule.16So as I mentioned, I've mentioned most of17this before. The main components of the preliminary18safety analysis safety report are the preliminary19design of the facility. A preliminary analysis of20structure systems and components with an eye towards21how those will be used to prevent and mitigate22accidents.23While you're not required to submit24technical specifications at this time, we are looking25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 43for the application to identify probable subjects of1technical specifications.2And again, while emergency plan also is3not required, there are some requirements in Appendix4E of Part 50, to address a preliminary emergency plan.5We'll also be looking at your quality6assurance program and any planned research and7development that you have.8Next slide please. So for the review that9we do, so the last slide talked about the regulatory10requirements that need to be met. We had developed11guidance in order to evaluate whether those12requirements have been met.13And for your application, the guidance14that we are primarily using is NUREG-1537, as15augmented by Interim Staff Guidance.16And the most applicable part of that, as17you used in the development of your application, was18the guidance for radio isotope production facilities. 19And that was largely based on guidance in NUREG-152020that Dave will talk about in a little bit.21Other guidance that we used. There are22ANSI standards that are referenced in these documents23we used for our reviews as well.24Next slide please. So getting more into25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 44the process and timeline. After you submit your1application, first thing the NRC staff does is review2the application to see if we have enough information3to accept it for docketing.4What goes into this acceptance review is,5we look at the request you made for the type of6application you are seeking. We see if we have the7technical information, the application to support that8request to conduct our review.9And if we're aligned on the request you're10making and we think we can review it under that11licensing process, then we make sure that we have all12of the information required by the regulations for13that process.14We're not doing a detailed review at this15time, we're looking for completeness of the16application. And if we believe that the application17is complete and has addressed all of the regulatory18requirements necessary for that type of application,19we will accept the application and docket it.20And once docketed, that indicates the21beginning of our formal technical review of your22application.23And following that, our technical review24ultimately will result in the publication of a safety25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 45evaluation report. Which documents the NRC's findings1on the application and our recommendation to the2commission on whether we believe the construction3should be, permit should be granted or not.4In support of development of this safety5evaluation report, the staff may find it necessary to6request additional information to help us understand7the information that's in the application or to8provide any additional details we need to make our9conclusions.10After we complete our safety evaluation11report, we will present this report and you will12present your PSAR to the ACRS. There will be13subcommittee and full committee meetings on this.14And the ACRS will provide an independent15review of your application and the NRC staffs16evaluation and provide a recommendation to the17commission on whether they believe the construction18permit should be issued.19Following this, we do have the potential20for a contested hearing. And there will be a21mandatory hearing. Where, again, the adequacy of the22safety and environmental reviews will be considered. 23And that will ultimately lead to the decision to grant24or deny the construction permit.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 46Next slide please. So I put together a1sample 22 month safety review timeline that's based on2our previous reviews. And also just kind of a middle3ground between that 18 to 24 month time period.4And I wanted to highlight just some of5what went into that so it doesn't, it isn't a complete6mystery of what we're doing while we're reviewing your7application.8So after docketing your application,9within about two months we are, our goal is to begin10issuing requests for additional information, if11necessary.12Our goal is to complete issuing our first13round of request for additional information within14about a six month time period. So that will take us15to, as you see on the screen there, in eight months16after the docketing of the application, our goal is to17issue all of the requests for additional information18that we may have on your application.19Typically, when we issue a request for20additional information, we will ask for a 30 day21response timeframe. If this is not something you22believe you can meet, you can talk to your project23manager and workout a time period that will work for24both of you.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 47So after about nine months, our goal would1be to have received responses from you on all of the2requests that we have issued. Following that,3reviewing the information and providing request for4additional information, it may be necessary to ask5additional RAIs.6So in this timeline we've incorporated the7need for a potential second round of requests for8additional information. That would require another9six months' time period.10After all of our requests for additional11information have been answered, and the staff is able12to complete a safety evaluation report, then we go the13ACRS. And right now, in this timeline, we have about1419 months after accepting the application for15docketing, we would hold our first ACRS subcommittee16meeting.17Based on our past experiences, with18licensing similar applications, we have seen that it19will be likely necessary to have multiple ACRS20subcommittee meetings.21In this timeline we have anticipated there22could be two ACRS subcommittee meetings. And these23can be held, essentially you would have an24opportunity, at most, once a month, while the ACRS is25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 48in session, to meet with them to discuss that.1Once the ACRS is satisfied, at the2subcommittee level, that you have addressed all of3their technical concerns with the application, a full4committee meeting can be scheduled. And after the5full committee meeting, the ACRS would prepare its6recommendation to the commission on your application.7Following the completion of the ACRS full8committee, the staff has been able to finalize its9safety evaluation report based on feedback provided by10the ACRS. And after that is when we would schedule11the hearing.12Next slide please.13MR. ADAMS: Can I, this is Al Adams, can14I -- I just want to emphasize one point on this slide. 15Although this slide shows 22 months, that you can see16the licensing activities are completed on this slide17in the first 18 months.18So there is time that is devoted to19activities, which are beyond the development of the20safety analysis. The visits to the ACRS and the21mandatary hearing.22So although it may seem like a 22 month23schedule, the actual licensing work is condensed into24the first 18 months of that. Thanks.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 49MR. FOWLER: And what I -- pardon the1interject here, but I see, you know, the objective2that I have in this meeting are to explore, how do we3accelerate schedules.4MR. LYNCH: Yes.5MR. FOWLER: And I appreciate this6outline. There is implicit assumptions about cycles7in here.8And that's an obvious opportunity to9reduce the overall time, if we reduce the number of10cycles.11MR. LYNCH: Yes.12MR. FOWLER: What is less clear to me is,13what drives subsequent cycles? Is there a threshold?14What's the bar that we, as a company, need15to meet to avoid a subsequent cycle and therefore16accelerate the schedule? That's what's not so clear17to me.18MR. LYNCH: So I think that there's a19number of things that we can do. And when we ask,20what we can do is, when we ask, request for additional21information, it's important that you understand the22questions that we're asking.23You can go to the next slide. Let me24answer your question and then we'll go through the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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. But1it's all related. That's the next topic I was getting2to.3But when we issued the request for4additional information, it's important that after5they're sent to you, you have them, read through them,6have a phone call with us. If we need to meet, we can7do that as well.8But we want to make sure that for every9question we ask, you clearly understand what we're10asking. And if you don't understand, you ask us to11clarify.12Because it cannot be the best use of13either of our times if you don't understand the14question we're asking. You answer what you think15we're asking, but that's not what we're looking for,16then we have to ask the question again.17So making sure that we have a clear,18mutual understanding of what the information gap is19that needs to be filled, that can help.20And then as you're preparing your21responses, check in with us again and make sure that22you still understand and you're going down the right23path. And providing complete answers the first time24they're asked can also help.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 51So I think one of the keys two reducing1the iterations that we have to go through in that RAI2process, is making sure that you understand the3question that's being asked and providing complete4responses to that.5MR. FOWLER: So we're learning how to work6with each other?7MR. LYNCH: Yes.8MR. FOWLER: And we've had some9experience. And, Nancy, maybe I can put you on the10spot here because we've now had two cycles of requests11for additional information with the environmental12portion of the technical review.13How would you characterize the ability for14the two organizations to communicate?15Is the second cycle driven by a16communications challenge or is it driven by, you peel17the layers of the onion back and you find something18that you didn't see the first time that initiated a19second round of questions?20So in order to be productive, help us to21understand, from the limited experience we have22already, how we could do it even better on the next23cycle.24MS. MARTINEZ: So for the environmental25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 52review RAIs, the second round of those RAIs were1driven by follow ups to the first round where the2question was not addressed adequately. So we had some3follow ups on that.4But we also had some follow ups on the5responses because information was provided, and then6we needed additional information just based on the7response. It was really a combination of some of the8questions were not answered completely, and then there9was responses provided, and then we had follow up to10that.11We also did, you know, when we issued the12RAIs, as Steve mentioned, we did say, let us know if13these are clear and if you would like to have a call14to discuss them. We did that for both rounds.15So we're hoping that that will open that16communication channel, as you just said.17MS. GAVRILAS: I want to take it a step18higher, because this is general. So you mentioned the19two cases. Indeed, those are the two instances for20which we ask additional RAIs.21There's an expectation that the technical22reviewers have started to write their safety23evaluations and are well along their safety24evaluations.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 53So when they ask, when they request1additional information, it's designed specifically to2augment the piece that they're writing right now. So3that means it truly -- they know exactly what they4want. Or they have a very clear picture of what they5want.6I'm not saying that the peel the orange,7you know, or onion, whatever you're peeling, doesn't8happen, but that's rare. Because of how we do, how9the expectation is that when you ask an RAI, you10basically know what kind of information you're seeking11to document your safety conclusion.12So along the lines of dialogue, there's13two times that there's opportunity for dialogue when14it comes to a request for additional information.15One is, when we are drafting the question16itself. Right? Because then we want to make sure17that we engage with you and make sure that the words18that we put on paper, do convey our needs.19And then there's a second opportunity to20engage in dialogue. Which is, when you've drafted21your answer, we have an opportunity to check that22indeed your answer answers the mail.23That is, in our experience, the most24efficient and effective way to deal with responses for25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 54additional information.1MR. LYNCH: Nicholas?2MR. TIKTINSKY: And I'd like to add a3little more on that too. A lot of it's nature of the4rounds of questions. And this is Dave Tiktinsky.5A lot of it is nature of the rounds of6questions. So if the questions are, you provided 907percent of the information we want and we need some8clarifications of something, then usually it only9requires one round.10If the questions are more like, you need11to develop or give us your methodology that you, how12you develop something or you're programing, we need to13understand what that is. Once we get that answer,14about what your program is or what your methodology15is, that may lead us to other questions.16So really it's the nature of how the17information was in the application, how specific it18was. And really the level of what that question is.19The specific questions, usually can handle20them in one round. The more programmatic, methodology21kind of questions frequently require follow ups.22MR. ADAMS: And, this is Al Adams, I just23want to build on something Mirela said. That that24discussion that we have, once you start to develop25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 55your answers, that's not a sort of a verbal review of1your answer.2I mean, you know, the reviewers have to3sit down and carefully consider the answers. What4that is looking for, if we're expecting an answer to5go in this direction, and when you talk to us, we find6out that you're going in a completely different7direction.8So it's basically to find significant9issues before you submit the answers to us. So if you10submit the answers to us without having that11discussion with us then, you know, then there's just12possibility for a misunderstanding or13miscommunications in the RAI process. And that can14contribute to additional questions.15MS. GAVRILAS: And we cannot, this is16Mirela again, we cannot emphasize enough how important17that dialogue is. Those are the, probably the biggest18contributors to our expediting the review.19MR. LYNCH: Okay. Actually, so I think20we've talked mostly through Slide 30. Let's go to21Slide 31, which will continue this conversation we22have on impacts to schedule.23And this, in addition to RAIs, there is24other things that we can do to help ensure that our25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 56review is moving along efficiently. And can impact1schedule.2One is the quality of the application3where all the regulatory requirements met. And this4is, I'm speaking hypothetically and not in your5application.6But if we do a review of the application7and the regulatory requirement is not met, it could8result in the application being rejected and needing9to be resubmitted. Or it could result in significant10new information that does need to be presented and for11review.12Technical and completeness. Again, the13more information you give us without having to ask for14it, the more efficiently we can review the15application.16And then also just attention to detail. 17And this has to do with the organization of the18application, formatting, looking at proprietary19markings. Just those little details that maybe aren't20necessarily technical, but can help us in our review. 21If we don't have to worry about the little things.22Then building on our conversation on23request for additional information, in addition to the24number of rounds we ask, the quicker that you provide25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 57responses to us, the quicker we can continue on with1our review.2So timeliness, responsiveness,3completeness of our requests and how you provide4answers to them, that can all help facilitate our5review.6And I think a good point that Dave7mentioned was, what can take more time is if in these8requests for additional information, significant new9information is provided that we have not reviewed10before. That can take additional time. And could11result in additional requests.12MR. ADAMS: Can I -- Al Adams. Can I jump13in here?14And completeness is probably the most15important of those things. If you, you know, we asked16for a 30 day response and you come in in 20 days and17look, you know, you've come in ten days sooner. But18those answers aren't complete and result in another19round of RAIs, that round is going to consume a lot20more than the ten days that you saved by coming in21early.22So completeness is the most important, I23think, aspect of this. And I think what you're seeing24is, you know, the thing that draws out schedules is25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 58having to go additional rounds of RAIs.1That's the most, you know, our experience2has shown us that's the most significant contributor3to schedules being drawn out.4MR. TIKTINSKY: Another thing I might want5to add too is, we're not going to wait till the end to6give you all the RAIs at one time. You saw that, the7schedule that Steve had shown there.8The idea is, when major portions of the9review are done, we will ask RAIs that are10appropriate. We don't want to be asking you the same11technical area a bunch of different times.12So when we're done with an area and we13feel like we're done with that part of the review and14comfortable with that, we'll ask those rounds of15questions. But we want to spread it out over that16time period, the six month time period that Steve had17outlined.18It's more efficient that way and it allows19your staff to work on it. Also, we don't want to hold20somebody up, you know, waiting for another disciplines21review to be done.22MR. ADAMS: So you may get a second letter23from us, but it's actually the first round of RAIs in24that area. And there's nothing to be gained by25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 59sitting on the RAIs and giving you a hundred questions1at once and overwhelming your ability to answer.2So when we have an area ready to go, we3will 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'd6just like to reemphasize that when, especially when7you're crossing different portions of the regulations,8that the clearer you are in your initial submittal9about, this is how we're meeting 70.32, this is how10we're meeting 50.20.11I mean just the clearer you are in your12application, will help us avoid those types of request13for additional information where we say, hey, tell us14how you're meeting the requirements in here.15And then if we're at that sort of basic16level of, how are you meeting the regulations when you17give us that answer, that's almost guaranteed a second18round because now we're going to ask you questions19about that.20I mean every applicant wants to avoid21going multiple rounds of request for additional22information. But it's just been our experience that23when we have to do those basic sort of questions24about, how are you meeting our regulations, that tends25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 60to, once we see the detailed technical information, we1tend to then have questions about that.2So I can't emphasize enough that initial3clarity in your submittal.4MS. GAVRILAS: So if I -- I'm sorry.5MR. MORRISSEY: No, that's okay.6MS. GAVRILAS: More comments on RAIs. 7Because I want to --8MR. MORRISSEY: No, I had just a9discussion about the technical reviews. My name,10Kevin Morrissey.11As having been a technical reviewer for a12long time, and actually I was a licensee, is my advice13would be, don't be shy about asking the staff what14they want.15You know, we're talking about all the16things we expect from you, you should expect to think17the same things and clarity from the staff. You know,18lots of time we go, I shouldn't ask this, I shouldn't19ask that. Is you really have to dig down sometimes20and let your staff talk to our staff and really get21down to exactly where you're going.22Then you're less likely to end up in the23wrong place and wasting your time. So don't be shy. 24That would be my advice.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 61MS. HELTON: Absolutely. Getting the1technical experts to communicate directly so there's2an understanding, is a good practice. To have a3public meeting on those RAIs.4MS. GAVRILAS: So again, it's important to5sum up. It's important to distinguish between various6increments at the same round, the RAIs and follow up7RAIs.8The increments are designed to help us9all. To move the process along.10The follow up required are basically11because we needed additional information. And while12we can't, those are the ones that we target for, for13minimizing. We can't eliminate them completely, but14we target for minimal follow up RAIs.15I want to go back on Slide 30, Steve, if16you can, for just one moment. Because there's --17we've talked a lot about RAIs and how you can do, what18you can do to basically help us out, speed the process19along.20But what's important in our timeline is21also to recognize that there's a safety reason for how22the timeline is developed. There's nothing that's23carved in stone, because it's arbitrary.24And I'll give you, as an example, the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 62writing of the SER. It doesn't help to distribute a1chapter in a technical area amongst reviewer. That2won't speed up the process. The review has to be3comprehensive. The reviewer needs to see everything.4If there are chapters that cross over5technical expertise, that needs to be seen by6everybody. So the timelines that you see that it7takes the staff to draft the SER and to come up with8RAIs, is also informed by basically what we need to do9to come up with a safety finding.10And with that, I'll turn it back to where11it was.12MR. LYNCH: Sure. Back to Slide 31. 13Again, this is Steve Lynch. Other impacts that, to14schedule, could be if there are policy questions that15need to be resolved. I can give an example from a16past, a past review.17In the case with SHINE, we had to go to18the commission to resolve how, you know, whether SHINE19should be under Part 50 versus Part 70, and we ended20up needing to do a rulemaking in order to classify21them under Part 50. That can be a potential impact to22schedule if that's something that's necessary in our23review.24Also, the one thing that can drive25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 63schedule, is the number of times we have to go to the1ACRS. Limiting the number of subcommittee meetings2that we have to have, by addressing the technical3concerns with the ACRS, can significantly improve or4delay the schedule.5MR. ADAMS: Al Adams. I just want to, the6ACRS tells us when they've received enough information7before they can write the letter they need to write to8the commission.9So it's something that quality has control10over, but we don't run the ACRS and the committee. 11And they have to do the review and reach the12conclusions they need to reach given what they're13responsibilities are.14MR. LYNCH: Yes. And what we can do to15help them is, when they do identify areas that they16need additional information, that both the applicant17and the NRC staff provide that as quickly as possible.18All right, next slide please. So on the19previous slide I was mostly addressing the things that20both the applicant and the staff can do to impact21schedule.22This slide is focused on the things that23are outside of the staff and the applicants control,24to a certain extent. And this gets into the hearing25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 64process.1And this comes after the ACRS meeting has2been held, the staff has completed its environmental3impact statement and the staff has completed its4safety evaluation report.5There will be a mandatory hearing on this6application since it is a commercial facility. And as7I just mentioned, but there's a lot of things that8have to happen before this mandatory hearing can be9held.10In addition, there is a potential, and we11put this out in our notice of opportunity for hearing,12members of the public could file a contention on a13portion of the application or the activities that are14being conducted. Or proposed.15And if that happens, those separate16hearings would need to be held and those issues17resolved before the mandatary hearing could be held.18After any hearings that need to be held19are held, including the mandatary hearing, then we get20the Commission's decision to deny or issue the21construction permit. Based on what we've seen for the22combined operating license applications, that have23followed a similar process to this, we have seen the24commission decision come anywhere between two and five25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 65months following the mandatory hearing.1So after the hearing happens, there is2additional time. And that's not time that the staff3can control, that's on the commission's schedule when4they make that decision.5Next slide please.6MR. BALAZIK: Hey, this Mike Balazik. I'd7like to provide a quick status update on the NRC's8review of Northwest construction printout application.9This slide shows the proposed schedule for10the review. Steve and others mentioned some items11that can drive the schedule, either delay or expedite.12As you can see, that NRC is actually13reviewing the application. And I just want to assure14you that we've allocated the necessary resources and15have the technical expertise to review all aspects of16the application.17As you can see on this schedule, the staff18has targeted September of 2017 for completing the19safety evaluation report. And then there's a couple20of milestones that we can't really put a date next to21yet.22There's a couple of related activities,23not on this schedule, I'd like to mention. One is the24license amendment application by Oregon State25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 66University to irradiate three prototype targets. This1amendment was issued in January of 2016.2And other item I'd like to mention is, for3the research reactors that you've proposed to do the4irradiations for Northwest, each research reactor5would have to submit a license amendment to irradiate6the targets commercially.7And we've received notice from the8University of Missouri that we can expect the license9amendment in calendar year 2016. And Oregon State10University has also notified the NRC that they plan to11submit their license amendment in first quarter12calendar year 2017.13MR. LYNCH: Okay. While we're on this14slide, do you have any questions about our review15schedule?16I think, and this is mostly based on17previous reviews and the sample timeline that we18developed. Do you have any questions on where we're19going?20MR. FOWLER: Well, I have an observation. 21And I appreciate this information. And I was somewhat22familiar with reading it.23And again, I'm looking to explore how we24can work together, while maintaining arms' length. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 67Obviously you have an ombudsman role and a review role1that is independent and so forth.2But I view this as a very critical public3health need. And I know everyone recognizes that, but4our sponsors and investors are major healthcare5institutions servicing tens of millions of Americans. 6They see this as a real issue that we do work7together.8They are not for profit organizations. 9They have a service mission to the American public. 10And they extend that service mission through us. To11provide this.12And they're expectation is that we work13collaboratively and creatively to not compromise14health or safety, but figure out ways where we can15reduce the number of RAIs.16How can the NRC better set our17expectations of what will minimize those rounds of18RAIs?19How can we work together to ensure that20the ACRS review is done in a single pass, rather than21two or three passes?22What do we need to do together?23And if we drop the ball, it's on us. 24Absolutely it's on us, if we drop the ball.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 68But if we know what the threshold is that1we're trying to reach, we will work our darndest to2get there. And that's what we're looking for. Is,3how do reduce the number of RAIs?4How do we, as much as we can, ensure that5there aren't multiple rounds through the ACRS?6Because if we reduce those number of7rounds and if we reduce the assumed number of RAIs, we8get a critical isotope to public much more quickly9than is even on this schedule. Or we, by insurers,10that this schedule is met and doesn't slip.11And that's the exploration that I'm very12keen on hosting. Because I think we have an13understanding of the process. Now how do we work14within that process, to have the most expedited15schedule possible?16MR. LYNCH: Okay. So I think, just at a17high level -- so where we're at right now, we're in18this February 2016 timeframe. We're anticipating19getting out our first request for additional20information on the safety review side. And I believe21we're on target for that.22So this is all heading towards completing23our draft safety evaluation report. So I guessing24you're looking at drive, making that June 2017 time25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 69come up sooner.1I think the best chance we have of working2towards that goal together, would be once those3requests for additional information are issued, just4like we discussed earlier, let's get a call setup as5quickly as possible so that we can discuss and make6sure you understand what we're asking. And --7MR. FOWLER: So to that point, Steve.8MR. LYNCH: Yes.9MR. FOWLER: You have insight by the10technical reviewers when an RAI is going to be issued. 11So rather than wait until it's issued, for us to12request a public meeting to follow up and then have13the mandatary noticing period and so forth, why don't14we automatically schedule a public meeting within15certain number of days of the RAI insight issuance, so16they don't have to wait longer?17MR. LYNCH: There are different ways that18we can do this. Yes.19And there have -- and the NRC can, you20could set up a standing public meeting once a month or21once every two months. You know, something like that. 22That could definitely happen so it's noticed and it's23already setup. That can be done.24Now it also depends on the nature of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 70discussion you would like to have on the RAIs. The1public meetings are more necessary if we need to have2detailed technical discussions about the RAIs.3If you would like to have a call, just4strictly on, do you understand this, yes or no, could5you explain to me at a high level if I'm not6understanding what it is, that does not necessarily7need to be a public meeting. That could be a phone8call between you and your project manager.9Or you and with appropriate technical10staff. Those could be very quick calls. If it's just11for understanding.12So it kind of depends on what we need. So13that can buy some time too. If it doesn't need to be14a public meeting, that can be done much more quickly.15MS. HAASS: Well, and that's why there was16the request, when we were at the EDO, was to go get17that standing meeting done every week, very short and18sweet, to say, okay, do we understand this. And then19we move on.20And so I'm glad that that got instituted21or executed that we're now doing that. And that has22helped.23MS. HELTON: I think when you talk about24the frequency, the right frequency for the standing25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 71public meetings, and they haven't been established1yet, but we certainly can do that. And we've got2other examples working applicants where we've met on3a biweekly basis.4So in terms, I wanted to chat and, I'm5sorry, this Shana Helton, about this question on6threshold. And what's the regulatory threshold that7you have to meet, as the applicant, to operate this8facility.9So the regulations, we went over the10NUREGs as they've been supplemented by the Interim11Staff Guidance. That is what we have set as the12threshold, if you will.13And each applicant is going to meet those14regulations in unique ways. With that said, you know,15we operated in a public manner. Everything is on the16docket.17We've alluded to similar reviews in terms18of looking at reducing the number of RAIs. I think it19would be helpful for you to do some research in ADAMS20for what similar designs, the types of requests for21additional information that we have had, and the types22of responses that have satisfied those additional23requests for information. And that should really help24to identify the threshold.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 72I mean that said, each application is1different, we review it on its merits. We're going to2have to take into consideration the unique factors. 3But that can at least give you a sense of the way we4think when we're going through these regulatory5reviews.6MR. LYNCH: Absolutely. I think that's a7very good point. And even more detailed in that, if8you really want to see, if you open up the safety9evaluation reports we write, especially those -- you10can look, for a good example, we just finished our11safety evaluation report for the SHINE review. And12using the same guidance that you used.13The guidance sets the threshold of the, at14the end of that, the NRC is explicit and the15conclusions that we are trying to make in each section16and each chapter that's provided. And there are17bullet points there.18And once our reviewers are doing the19reviews, they're looking at the bullet point, you20know, for the acceptance criteria. Was this21information provided. And then there's another bullet22point, can we draw this following conclusion from that23information.24So when we're looking at your application,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 73we're trying to answer those questions. If we can't1answer a question affirmatively, that's one of the2times we'll go to you for a request for additional3information.4Also, as you'll realize for a construction5permit, you may not have all of the information that6you would submit at the operating license stage. What7can also help the reviews is an explanation of the8information that you don't have right now, because9your design isn't compete, explaining why it's not10ready right now, but also acknowledging that you11recognize it is something necessary for the final12design.13The more, again, it comes back to the14completeness. The more information that you can15provide us, addressing the information that we're16looking for in the guidance, the quicker we can get17through the review.18And also we are kind of, since we're using19our guidance, NUREG-1537 and the ISG, that's kind of20the format that we're looking for. You can submit21your application in whatever form that suits you.22However, if you can expedite the review,23it does make it easier if it's generally aligned with24the guidance that we're using to go through with. So25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 74that's some other insight.1MR. TIKTINSKY: If I could add some more2on the RAI meetings? You're right. We don't just3wait until they're all done and then make a phone call4to you. We know when they're coming, we know when the5reviews are done because we, as project managers, we6work internally with our reviewers to try and make7sure we're asking questions that are clear, that have8appropriate regulatory basis.9So we're working internally. So we know10pretty, some time in advance, before we're getting11ready to formally issue the rounds of RAIs. And we've12had a lot of experience doing that. And having13setting up meetings.14And just for your information, you know,15parts of the information, like within the ISA, there's16other categories, besides proprietary information. 17There's security related information.18So the public meetings that we have, we19try and talk as much as we can in publically available20information. But there may be some portions of the21meetings that are closed. Not only for proprietary,22but for security related information and other23discussions.24So what we try and, you know, we develop25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 75in RAI, we try as best as we can to make the RAIs1themselves publically available. So that information2is out there.3Your answers may or may not be publically4available, but like I said, we've had a lot of5experience in other reviews of making sure we have6those conversations.7I'd also like to emphasize the point too8is, depending upon the nature of the answers, we do9the same thing. Have the same kind of meetings when10you submit answers.11So before you formally submit something to12us, it may be a call or you may have a meeting too. 13If you have substantial discussions about something to14make sure that you're really are hitting the mark.15Again, we don't do reviews on the fly, but16you can get a pretty good sense that, yes, if you're17on the right track or not. And that would minimize18any problems.19But yes, we do plan things out. We try20and coordinate that carefully with the reviewers. And21we know where the status of things are.22And again, that's why I mentioned before,23we're not going to just consolidate a bunch of24different disciplines and do it at one time, we're25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 76going to try to phase this through, review it and try1to make it as efficient as we can.2MR. ADAMS: And this is Al. I'll just add3two things. One is, NUREG-1537 is a guidance4document, but it is an important document in that it's5a format content guide and the staff standard review6plan.7What we expect for RAIs is that the RAI8will start by saying, either here's a regulatory9requirement or here's something that the standard10review plan is looking for, here's where your11application, the information in your application seems12to say something different or doesn't seem to have13this information. And then the question will come.14So, you know, NUREG-1537 is your friend15for understanding what we're looking for.16The other thing, you talked about the ACRS17for similar application to yours. There are18transcripts of the ACRS meetings. You can go read19those transcripts and see what areas interest the20ACRS, what areas they focused on, where they asked21both us and the applicant questions and issues that22became, you know, issues that were sort of follow-on23issues.24So there is an advantage for you being25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 77second in the queue that there is information that's1available to you. And that's an important source of2understanding how the ACRS works, what they think,3what they look at, what they consider important.4MS. HELTON: Also publically, this is5Shana Helton again, also publically available on the6advisory committee is their charter. You know, I7encourage you to look at that. They're mandated by8statute. They're an advisory buddy to the commission.9The staff does not have much influence10over how they operate with their schedule. The11members need whatever information they need before12they'll go to a committee and write a letter.13So while we can attempt to work with the14ACRS and, you know, it's very difficult to try to15manage that schedule. They've got competing demands16and they only get together once a month. There are17certain months of the year that they typically do not18meet. So it tends to be fair.19You know, you see an August meeting up20there, I don't think they usually meet in August. 21Sometimes they make --22MR. LYNCH: Subcommittee does, full23committee does not.24MS. HELTON: Full committee does not. So25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 78I'm just saying, there is some limitations in working1with the ACRS. They have a statutory role to fulfill2and they take it very seriously.3So looking at those old transcripts can4help try to predict what, as they're membership5changes, you know, it's just, it's a variable that's6well out of the staff's hands. That's all I can say.7MS. GAVRILAS: This is Mirela Gavrilas. 8And we have, the staff has experienced working with9the ACRS. The staff knows the ACRS' schedule.10The ACRS itself, from our previous11experience, the ACRS too recognizes the importance of12this activity. Of establishing a reliable, domestic13supply of molybdenum-99.14So while there are challenges, they will15work with us. We know how to work with them. And16past experience says we've been successful to make17that as effective of interaction as possible.18MS. HELTON: Absolutely.19MR. BALAZIK: This is Mike Balazik. I20guess I just have one question. We've been, for the21environmental review, we've been through two rounds of22RAIs.23We have been sharing those in draft form. 24We've offered calls. I mean, is there more that we25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 79can do on these?1I mean, I guess I'm just kind of asking,2what can we do differently? We've been through two3rounds to help Northwest with the understanding of the4RAIs. I guess it's just a question that --5MS. HAASS: Yes, I don't think there's a6disagreement of we don't understand the RAIs. There7were actually, you know, we had a public meeting, you8know, when we did the site visit, there was some9agreement that the RAIs were complete. You did come10back and then say you wanted some additional11information.12Then there were quite a few additional13ones in the second round as well. And it was based14upon some additional information you asked for.15And so I do think it's complete. And it's16sitting here for you.17MR. BALAZIK: But it, this is Mike Balazik18--19MS. HAASS: Now, there really isn't20anything else we can do accept keep communicating. 21But remember, it wasn't until the EDO meeting, until22we requested that we have these weekly meetings here,23I'm sure that there was an understanding.24MR. BALAZIK: This is Mike Balazik again. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 80There's a difference between the weekly status call,1which is just overall --2MS. HAASS: I know the staff, knowing what3we had and where there is a question and how we would4go about resolving that. And it could be a public5meeting or it could be just, you know, there was a6misunderstanding and it was just a quick, you know, we7understood it.8MR. FOWLER: So I see three areas that9offer opportunities to explore expediting. The first10I'll call administrative in nature. And those are the11mandatory noticing periods, the number of meetings and12so forth.13The better we can be in advance of14understanding when those need to happen, we can15eliminate more time that's simply waiting for one of16these periods. Or waiting to have a meeting.17That's probably the most frustrating to me18is having to wait for things. I never want either19team to be in a position of waiting for things. 20Because that, by definition, is lost time in the21schedule. So I call that administrative.22Then there's this area of technical. And23what I'm -- I've heard the term, completeness used24sufficiently that it will be lodged in my memory.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 81And so -- and that comes through dialogue. 1In order to meet this threshold of completeness, the2technical teams need to be in communication so there's3no misunderstanding of what completeness is required.4And I want to test to see we have the5appropriate communications mechanisms in place, to be6sure we're meeting the completeness guidance.7Then there's the regulatory or precedent8guidance. Which comes to what I've termed threshold. 9What threshold do we need to meet.10And that's really on us. We've got to do,11and have been doing and will continue to do, research12into threshold regulatory.13So those are the three areas. Obviously14the last one is something that we have to work on15independently.16The other two I believe are areas to17explore whether we've done everything together that we18possibly can do to meet and better the schedule.19And I'm sorry, Mirela, you were going to20make a comment.21MS. GAVRILAS: Wow, that was, I'm taking22notes furiously because I want to answer to, to answer23a couple of things.24So let me go with, as far as the status25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 82meetings are concerned, that's our practice. So I'm1not sure when we implemented it, but I know that we2had the same --3MR. LYNCH: We talked about it in4November. Or no, actually August, at the National5Academy of Science --6MS. HAASS: It just didn't get implemented7until about a month ago.8MS. GAVRILAS: Okay. But that is part of9our practice. To have those status meetings. But10their status meetings do not touch on anything that11Nick just mentioned.12Okay. So as far as communication, that's13what I was writing. The regulatory guidance is the14first place to look to see what the yardstick is for15completeness.16Our discussions, discussions with the17staff are intended to augment that. Not replace that. 18So they come in addition.19And sometimes there's no additional needs20for communication. Sometimes there are needs for21communication.22So we need to work together. As soon as23you identify a need for further discussion, you need24to let us know. And we'll do our part in anticipating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 83when it's likely that you will have additional1requests.2Because, for example, if we know that3we're asking a broad reaching RAI, like Dave just4mentioned. If we're asking you something, what was5your methodology, then we can see how that would6require an interaction in the public to discuss7further.8So it's both sides. We both need to be9aware. And I think we can both, at least we can10committee to our part, to have that awareness and try11to be proactive.12MR. BALAZIK: Yes. And this Mike Balazik. 13And the whole idea of the status call, the weekly14status call, that was to be implemented as when we15accepted the application.16I didn't see it, weekly calls, before17that, until we got to that point of acceptance of the18application. So that was --19MS. HAASS: And that was a little20different understanding. But no, I'm just glad it's21done.22MR. BALAZIK: Okay.23MR. LYNCH: So, just to finish up with24this slide, did we help with understanding ways that25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 84we might be able to help accelerate the schedule in1terms of strategy? Any other questions do you have on2that right now?3MR. FOWLER: I think I have a good4understanding of the areas that I tried to summarize.5MR. LYNCH: Okay.6MR. FOWLER: And what I would like to see7and what I would ask of our team is, okay, now8translate those areas into a plan. What are the9processes and procedures that we've put in place, what10are the accountabilities, what are the milestones,11what in fact are the definitions of success or lack12thereof so we know we're on plan or off plan.13It's all about project management, once we14understand what the plan it.15MR. LYNCH: Okay.16MR. BALAZIK: All right, this is Mike17Balazik, I'll continue on. We want to go through18docketing. Steve mentioned earlier what docketing19was. And I just wanted to go through the timeframe20for docketing of the Northwest application.21First I'll start with the Part 1. 22Northwest submitted Part 1 of its application three23times. Once in October 15th, another time, 29th, and24November 7th of 2014. This was before providing the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 85NRC with a version that was acceptable for processing1and conducting an acceptance review on February 5th.2The NRC issued a letter to Northwest on3January 23rd notifying Northwest its application was4incomplete and unacceptable for docketing. Northwest5was allowed 30 days to supplement that application. 6And Northwest chose to withdraw the application and7resubmit. And that was the February 5th, 2015 date.8The reason for some of the delays was9inappropriate markings of proprietary information. 10Also, ADAMS had rejected the document due to numbering11of pages.12When they see a document has so many pages13and it doesn't match up, they'll reject the document14and try and get it resolved.15So Part 1 of Northwest's applications16accepted for docketing in June of 2015. And that was17approximately two months after successfully processing18it into ADAMS.19And just real quick on Part 2. They20submitted the application, Northwest submitted the21application, on July 20th, 2015. However, due to22formatting and improper proprietary markings, the23application was not fully put into ADAMS until24September 18th.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 86The staff completed its acceptance review1in the mid to late November 2015. And before2notifying Northwest on its acceptance decision, the3staff held a public meeting in late November. And4provided Northwest an opportunity to clarify its5requested licensing action.6Following the public meeting, the letter7of acceptance was issued in December of 2015.8One thing I would like to add is that9Northwest submitted large portions of its applications10in hard copy form, which lead to delays in processing. 11In ADAMS, when you submit 1,600 pages, it takes awhile12for them to process that.13Going forward, submission using the14electronic information exchange may reduce those15delays. I know that, Carolyn, you've expressed some16difficulties using that system, but I can provide you17a contact that can help you provide documents in that18form. So just --19MS. HAASS: So is, I'll put it this way. 20If you begin to do that, you have restrictions and21limitations. Because it is a very archaic system.22And because of that, the granularity of23graphics and pictures would not be coming out24appropriately. And it just absolutely made no sense.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 87And we had a lot of difficulty with your1system that we would have two different files, exactly2the same thing, one would be accepted and one3wouldn't. And we couldn't figure out why.4And it was taking too much of our time. 5That's why you saw the first part tried to be6submitted twice. Because we couldn't get it through7the electronic system.8You have a graphic capability of 300dpi. 9Our logo is more than 300dpi. And it's on every page. 10It just isn't worth our time.11MR. LYNCH: I believe the 300dpi is a12minimum, not a maximum.13MS. HAASS: No, it's maximum. I mean14there's some real difficulties. And we have a premier15person who does our documents, and I'm going to tell16you, it is one of the more difficult systems that17we've ever had to use.18MS. GAVRILAS: So --19MS. HAASS: You know, I don't want to take20this meeting over with that, and we can discuss it21later, but --22MR. FOWLER: This is an area, so fully23understand the dates. We're well aware of the dates. 24The report that I get from my team would characterize25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 88the difficulties differently from the way the NRC1characterizes the difficulties of receipt.2I think we can summarize this, that this3is an area that is, we should better understand4whether this can be improved. Because we sit here5today with another stack of paper, to respond to RAIs,6because of my teams perceived inability to work with7the electronic submission system. That's a problem.8Now it could be us, it could be the9system. But let's take it off and figure out how to10fix that.11MS. GAVRILAS: Just a point of12information. Quick one. The system is designed the13way it is because the intent of the system was to14enhance transparency. So that the documents can be15viewed on the processors that were prevalent at the16time at which it was deployed.17MS. HAASS: Right. And that was the18issue.19MS. GAVRILAS: So it was an optimized --20MS. HAASS: Right.21MS. GAVRILAS: -- optimized two aspects of22our mission. One is, openness, reached the broadest23set of stakeholders. And the other one is, making it24easier for our stakeholders, for another set of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 89stakeholders, the applicants and licensees to use.1MS. HAASS: Right. I mean it is a catch-222, but we also had to get to a point where we did it3the easiest for us because it would, you know, if you4have to take every graphic out and do everything5individually and save it individually, it becomes so6cumbersome that you will make more mistakes.7So we can look into it, you've heard my8comments on your system, and there's lots of room for9improvement on that side as well.10MS. GAVRILAS: Noted.11MS. YOUNG: Well perhaps we can get them12in touch with or possibly with somebody can stop in13today and just give a general explanation of the14electronic filing.15MS. HAASS: We --16MS. YOUNG: Because my understanding is,17not only do people submit by transmitting18electronically, but they also put information on the19CDs. But if the CD files meet the format, it can be20easily put in.21And applications like --22MS. HAASS: We do put a --23(Simultaneously speaking)24MS. YOUNG: -- requirement.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 90MS. HAASS: We've tried the CD submission. 1But, you know, we have talked with them. We can do2that more in the future.3MS. YOUNG: Because I know you're4interested in saving time. And any unnecessary --5MS. HAASS: Yes, but we're not going to6solve either problem today.7MR. BALAZIK: I think this is a good spot8to take a quick break. Next we'll go into Part 70.9So ten, 15. Let's take a 15 minute break10and start at 10:30. All right, we're going to go mute11on the phone and we'll be back at 10:30. All right,12thank you.13(Whereupon, the above-entitled matter went14off the record at 10:14 a.m. and resumed at 10:3315a.m.)16MR. BALAZIK: Good morning. This is Mike17Balazik again and we are going to resume the public18meeting.19Right now we are on Slide 36, the NRC20Licensing Process. This is, we're going to be21discussing Part 70 and I'll turn it over to Dave22Tiktinsky.23MR. TIKTINSKY: Okay. Thanks, Mike. I'll24kind of make a point, my presentation is generally25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 91more, you know, general Part 70, but I have a couple1of things that came up from this morning's discussion2that maybe will help sort of set the frame.3Some of it is some of the keys to4effectively, at least on the Part 70-type things, is5making sure there is a good understanding of6applicable regulatory requirements.7So we talked a lot about RAIs, that's sort8of the finer thing after you submit something, but in9the case of Part 70 is making sure you understand the10requirements and if you, you know, if you understand11them then obviously when you submit an application12related to those things you'll be able to, you know,13hit the mark better.14And, of course, if there are any specific15questions related to applicability of specific16sections of Part 70, how it gets implemented, then,17you know, the form of pre-application, public meetings18that we've had on other things for the Part 50 part,19you know, may be appropriate.20So that's some other ways of making sure,21you know -- You know, a lot of the discussion was, you22know, you give us a quality application, well in the23CP you have already given us an application, so24whether, you know, maybe you would have done something25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 92different in the future, it doesn't really matter now1if that's already there.2For other future applications you can take3a lot more of that into account of the experiences4that you'll have with the CP as well as the other5experiences that we talked about for other facilities6to try and make sure, you know -- You know, the best7way to minimize, you know, RAIs is to hit the mark as8much as you can.9So just sort of to get started on Slide1037, just a little bit about Part 70 requirements. You11know, Part 70 is relatively brought up if you have12broad regulation to cover a whole bunch of different13things and it talks about, you know, establishing14procedures for issuance of licenses, you know, to15title to own, acquire, deliver, receive, possess, use,16and transfer.17So that's a quite a lot of different that18it covers. There is a lot of activities that are in19there related to, you know, possession and use. There20is the scrap recovery and licensing a fuel cycle21facility.22So that's, it's a -- Again, it's a fairly23broad regulation to cover a lot of types of facilities24and activities for special nuclear material.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 93The next slide, Slide 38. It's a good1example here of, you know, kind of in parallel to what2Steve talked about in Part 50, and these, again, not3to, tend to be comprehensive, you know.4The regulations in 70.21 what the5application should be, how to file it, that, again,6emphasize the fact that you can incorporate7information by reference.8So if there is information that you9already provided for your other parts of the facility10you don't need to repeat them, you can just reference11them.12Again, the clarity of those references13helps the reviewers a lot, you know, the use of14crosswalks, tools, you know, whatever is efficient.15We want to make sure that the reviewers16know where the information is, know how to find it,17find it quickly, you know, and shows how it meets18those particular regulatory requirements.19It also has allowance to, if in Part 70 in2070.21(b) that you can have other licensed activities21specified in regulation, as long as the specified22regulations are met.23So, again, it's the combining of24applications and licenses. It's not just in 50, it's25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 94in 70, it's in other parts, so you are allowed to do1that.2Again, the biggest emphasis that I will3have on that is regardless of the form that it turns4out you need to be able to demonstrate that the5regulatory requirements are met and the clearer that6is demonstrated the easier it is to get through the7review process and then timeliness for that.870.22, the content of applications, there9is various requirements in there. 70.23 talks about10approval, so, you know, 70 is a little different than1150, the requirements are somewhat different, the12findings are different, but they are sort of still in13parallel to the, you know, public health and safety.14So it's the same theme even if some of the15details are different. I think related to criticality16accidents, for example, you know, criticality17monitoring systems and the applicability of, you know,18subpart (h) which has additional requirements for19certain types of licenses authorized to possess20critical mass and material.21The next slide, Slide 39. So NUREG-1520,22which is the standard review plan that we use for a23fuel cycle facility license application, the first24thing to think about is the information that's in 152025NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 95shouldn't be, you know, that much different than what1you've seen in 1537, the augmented ISG, because a lot2of that was taken from 1520 and some of it just copied3for the applicable portion so a lot of it is the same4types of methodologies that you would use for the Part570 application under 1520 or already in 1537.6So it's not like you would have to7demonstrate using different approaches for Part 70,8it's the same approaches and then -- or 1520. Again,9the regulatory findings that are discussed in 152010talk about Part 70 regulatory findings.11The regulatory findings in 1537 talk about12the regulatory findings for Part 50. So that's sort13of where the difference the staff in its review of14Part 70 applications has to make Part 70 findings for,15so it's sort of, you know, tailored to the specific16regulation.17The document, you know, provides guidance18to the reviewers, perform safety environmental19reviews. Again, you are not required to follow what's20in there, you can propose alternatives with21justifications, certainly perfectly acceptable.22Things that are usually smooth, if you're23trying to go, you know, veer a lot from what's in24there and you have to prove it, and your case may be25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 96difficult, it may take more time.1Again, it's not a definite on that. It2is, again, depending upon what it is and what is your3approach and what's appropriate for your particular4facility.5Following formats that match something6that we recognize are easier. Again, the easier we7have to track the information that we need, the easier8the review goes.9It also provides guidance for various10things, you know, new facilities, amendment renewals,11a lot of different activities, but the activities are12similar to the things that you are doing under, in13Northwest.14So it's not a foreign -- 1520 relates very15directly to the kinds of things that you are doing16that would be in your application, so a lot of it is17applicable.18It also makes references to other NRC19guidance documents, some of them like 1513, which20relates to the ISA, Integrated Safety Analysis21Guidance, which, again, what's in 1537 refers to the22same to documents, so, again, it's not a foreign23concept of what it is referring to.24The next slide, Slide 40. So sort of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 97purpose of, you know, why we even have an SRP it's,1you know, if you have a, it's across the board for2quality uniformity of review.3We want -- It's guidance for the staff of4what they should be looking for and how it should be5looked across various facilities so we treat everybody6the same regardless of what type of facility it is.7At least in uniformity the review would be8the same even if the information may be different9based on specific requirements in the regulations for10a specific type of facility.11Again, it's the guidance related, it's 12meeting the underlying objectives and the regulatory13requirements, so there is more information in there. 14Again, if you look at the regulation it talks about15the kinds of things you have to do.16The idea of having the SRP is to give more17guidance and details of some of the kinds of18methodologies and approaches that the staff would find19acceptable.20As I mention this flexibility, you don't21have to follow it, but you have to, you can provide22alternatives and also address it as, you know, Part2320, Standards of Radiation Protection, and Part 70.24You know, Part 70, what's somewhat25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 98different than Part 50 is, you know, the chemical-1related hazards that are considered in Part 70 based2on the nature of the activities that are done under3Part 70 facilities.4Next slide, Slide 41. So the guidance5that we have in the regulations of 70.31 for issuing6a license, so once we determine that all the7applicable regulatory requirements are met we can8issue a license in the form and then you will have9conditions as appropriate.10You know, conditions, for example, may11relate to, you know, you have to A, B, and C before12you can have material. There may be other things. 13Again, as we do the review and we see where you are14there may be specific requirements of things that we15would put in in the license conditions.16We have done this for other facilities. 17Again, it's not different than any other fuel cycle18facility. If you look at other fuel cycle facility19licenses you will a series of some standard conditions20and then other ones that are specific to that21facility.22So we would expect something to be here23for this, this particular activity also. Even in a24combined license you still have license conditions25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 99that you find in there.1So then we would -- Again, if it was one2piece of paper you would still find the same technical3conditions, license conditions in that piece of paper.4Next slide, Slide 42. So, you know, how5does the applicant demonstrate, and let's say that the6regulatory requirements are met, we talked a little7bit earlier about, you know, how you do that. So you8can, you have a choice.9You can combine it with the Part 50,10Production Facility Applications, in the case it could11be the OL. Again, where it's not specific of exactly12when you would submit that document you could do it as13a standalone document. Again, you choice.14The key thing, again, I'd like to emphasis15is you have to demonstrate the regulatory requirements16are met and if you are going to use multiple17applications in different places then, you know, the18easier you make it for the staff to know where those19requirements are found the easier the review will go.20MS. HAASS: Will you be doing a separate21safety evaluation report from 70 to 50 even if it was22combined, if it's separate you would do them23separately, if it was combined would there be one? 24How would that work within the NRC?25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 100MR. TIKTINSKY: Well part of it is, and1exactly where and how many documents sort of depends2upon how you submitted it to us, but we --3MS. HAASS: But it was combined?4MR. TIKTINSKY: We would have to make, our5SER would have to make combined regulatory findings if6we were making the regulatory findings on the Part 507side.8MS. HAASS: Okay.9MR. TIKTINSKY: We would have conclusions10for the Part 50 part. We would have to make11regulatory conclusions in the same document for the12Part 70 part.13So we would have to make sure we had them14all in there, that they were comprehensive. So just15like you would need to demonstrate that you met all16the applicable regulatory requirements, our SER would17talk about the staff's acceptance, the reasonable18assurance, for all those regulatory requirements.19MR. FOWLER: More pertinent to the20previous conversation is does one pathway offer an21easier, faster schedule than the other pathway?22MR. TIKTINSKY: It's hard to say in terms23of the speed. Clearly, the easier you can make it on24us to understand what you are doing and, you know, not25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 period1between submittals of one and the other then, you2know, tech reviewers that reviewed one part have to go3back and look at it to make sure they have covered it.4So there is some efficiencies in having5the same people looking at both aspects at the same6time. So I know about that --7MS. HELTON: If we go ahead a couple of8slides I think we're going to get to that, too, but9Dave is also going to talk about the differences10between the 2-step Part 50 license and the 1-step Part1170 license.12So Part 70 is a 1-step licensing process,13so there are some differences and the key I think is14ensuring that whenever you seek to fulfill the15requirements of Part 70 that you provide all the16information.17MS. HAASS: Right.18MS. HELTON: There is different -- You19know, you have seen that the bar for the construction20permit, it's a different bar, you don't have a design21set and --22(Simultaneous speaking)23MR. FOWLER: And this is why from -- I24have narrowed it, the choices in my mind are narrowed25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 102to two because we have to have all of our finalized1design complete for the operating license under Part250, which is then a 1-step process because the first3step has been complete, or we submit it under Part 70.4So if I make my question more precise, is5there a difference between providing the same6information, meeting all the regulatory hurdles under7the operating license for Part 50 in contrast to a8separate application on your Part 70?9MS. HELTON: It might be helpful to step10forward in the slides and see if we don't address11that.12MR. TIKTINSKY: Okay. Yes, see if we go13through and see if I answered the question or not.14MS. HELTON: Yes.15MR. TIKTINSKY: How about that?16MR. FOWLER: Okay.17MS. HELTON: Sure.18MR. TIKTINSKY: So, and, again, just the19thinker that if they are combined then we need to make20sure how they are met so it's clear to reviewers.21Forty-three. So to sort go with what we22have looked at, so from what we have received in the23docket so far the staff doesn't believe we have24sufficient information to do the conduct review of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 103target fabrication scrap recovery activities right1now. So I think --2MS. HAASS: But it was never expected to3be at that level.4MR. TIKTINSKY: Yes. So it's just that,5that's my understanding that there was not.6(Simultaneous speaking)7MS. HAASS: Yes.8MR. TIKTINSKY: We just want agreement9then, we all agree that there is not, we don't believe10there is sufficient information.11And from our review of those activities,12you had mentioned in your application that you13believed they were under Part 70, so how we look at14them they, I guess the first part is they don't appear15to be covered by Part 50, so that's sort of, it's not,16it doesn't meet the definitions of production facility17under Part 50 and they appear to be subject to Part1870.19So that's sort of our looking at what --20Even, again, you have not submitted the application,21so it's hard for us to make a definitive, you know,22determination of what is there without that, but23that's what we believe at this time.24And for us to actually conduct, you know,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 104the safety review and issue a license, because1obviously you would need to submit an application2meeting all the regulatory requirements.3And the burden is always on the licensee4to demonstrate that they, or the applicant and the5licensee to demonstrate that they meet regulatory6requirements.7The staff does findings of reasonable8assurance that you do meet them to protect the public9health and safety, but the burden is on the applicant.10Sort of in addition to or in lieu of for11some specific licensing questions related to, you12know, specific aspects of what's applicable, you know,13we talked we talked about pre-application meetings.14We would like to know, you know, if you15believe certain parts of Part 70 are applicable or not16applicable and have why they are not applicable we can17have pre-application discussions of them.18Again, going back to my first point of19making sure there is a good understanding of things20because for any facility pretty much in, or activity21in Part 70, there are some parts that apply and some22parts that don't apply just on the nature because Part2370 is a broad regulation.24You can, you know, control things like MOX25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 105facilities, which is different than, you know, uranium1enrichment facilities, so there -- But the regulation2is written broadly, so, you know, your understanding3of what you think you need to meet, having discussions4on that would probably be useful to make sure we were,5you know, had some alignment, you know.6We don't want to play the bring me rock7where you just, you know, send something in and we say8no, you missed the mark, so we want to have those9discussions because there where you add to timeliness,10or had the time to doing a review if you do that.11So, you know, as we have mentioned, you12know, many times those communications and13understandings are really important to make sure we14hit the mark.15But, again, it is, you know, Northwest's16responsibility to demonstrate what they think they17meet, what you think activities apply, what18regulations do you think you meet, and how are you19going to demonstrate that they are met.20The Slide 44 talked a little bit about21schedule and, you know, Steve had presented a schedule22to you, and that was a very good outline of the types23of activities that get done in a review, so what I24present here is sort of, you know, if you were just25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 106submitting a Part 70 application this is what we would1tell you that, you know, it's typically about 182months to do a review.3We do a technical review of the4application. Again, whatever it was, if it was5submitted with the Part 50 or not we will do a6technical review of the applicable regulatory7requirements, issue additional requests for additional8information, draft a safety evaluation report, you9know.10There is slight differences in terms of,11you know, the process and terms of, you know, there is12not a mandatory hearing for this type of facility in13Part 70 compared to 50, so there's some, you know,14subtle differences.15But I guess the major point here is the16review can be done in parallel or a series, so it sort17of depends when you submit it.18So the 18 months I show here, you know, if19you wait until after you submit it and we reviewed an20operating license application under Part 50 then you21sent us one then that clock would start when you22submitted it.23If it's with it then we could do that24review in parallel, so it wouldn't be adding to the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 107time.1So, again, a lot of it depends upon where2you want to submit it, what is strategic, you know,3for your company, when you think you are ready to have4all the requirements.5And, again, in Part 70 the 1-step license6requires, you know, a further development of things7than a construction permit and it is also slightly8different than what's in an operating license.9Again, the regulatory requirements are10different so it doesn't necessarily line up 10011percent but it is your choice to, when your12information is available, that you think you can meet13to demonstrate the Part 70 then you can submit it.14If that happens to be with the operating15license that's perfectly acceptable to us. If it16happens to be before or after, I mean, again, that's17acceptable, you know.18Again, the key is to make sure that, you19know, you have an application that's complete, that20has all the applicable regulatory requirements21addressed.22MR. LYNCH: And just to add on, and I23think Dave is absolutely right. I guess what it comes24down to, I'm glad we're in agreement on the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 108information itself that needs to provided and I think1that the main comment in terms of what's more timely,2the sooner we have the information the sooner we can3begin reviewing it, if that helps you in planning when4you submit.5But I think from a Part 50 standpoint it's6important to think about, also, that is there still7related activities that are happening under the same8roof.9So in order for us to make our safety10findings under Part 50 for a production facility we11will be interested in how other activities happening12within that building could impact, and I'm sure it's13the same going both ways.14So while you can submit the information15whenever you would like to, it's all related and we16need to know the impacts that those activities will17have on the different, within the building on the18different other activities that are happening as well,19and whether it's the manufacturing of the targets or20the processing of those targets.21MS. HAASS: Well and that was the concept22of our Part 1, Part 2 submission was we showed an23overall facility, because you are trying to show all24the safety-related activities, you know, and how they25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 109interact with one another.1MR. LYNCH: Yes.2MR. TIKTINSKY: Yes, it sort of emphasizes3--4(Simultaneous speaking)5MS. HAASS: But I can't do one without the6other?7MR. TIKTINSKY: Yes, to emphasize Steve's8point, I mean we, you know, individually look at the9Part 50 portion of the facility we need to consider,10you know, an external, which isn't really external in11this case because it's maybe the room next door.12But you still have to consider those13activities in the Part 70 one and on the 50, and just,14and the same way we would, if you were just looking at15just the 70 piece in isolation we would be interested16in the impacts of what the Part 50 facility around it17was impacting on that in terms of, you know, accidents18and analysis and things like that.19So we would look at it both ways because,20again, we have to make a regulatory finding for those21specific parts of the facility for those parts.22MR. JOHNSON: So, Nick, did that answer23the question that you asked a couple slides back about24are there efficiency -- What a thought your question25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 110was, are there efficiencies with going one route1versus the other, submitting a separate standalone2Part 70 versus incorporating all of the, how you are3satisfying all of the requirements into the CP, is4that what you were asking?5MR. FOWLER: Yes. And, further, is there6a material difference between the strategy of7application submission?8And what I concluded from the conversation9there is not a material difference between submitting10under a construction, or an operating license out of11Part 50 in contrast to a separate and distinct Part1270, the same steps, that it's not going to be easier13for the NRC.14In many companies it would be easier to15have a separate Part 70 application because some of16the conversations could be more easily17compartmentalized even though they do relate to other18things.19What I concluded, rightly or wrongly,20there is not a material difference. And to be clear21from what's in my head there is a 2-month difference22right now between the critical path of us entering the23supply chain with quantities of moly under Part 50, a242-month slip on the Part 70 puts Part 70 on the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 111critical path. That's how tight these two things are1together.2Plugging in all of the assumptions from,3well the guidance that we receive from the NRC, there4are only two months difference right now and so if5there were a material difference in review process6cycle time it could very easily affect the entrance of7this critical isotope into the supply chain.8That's how granular -- I manage the9schedule. We're down to a month.10MS. HELTON: So I think, you know, we've11emphasized the importance of communication on both12sides. You know, you want the frequent public13meetings, we can do that.14And I think what would be really helpful15is to have a public meeting or a series of pre-16application meetings where as you solidify your plans17for your operating license and meeting the Part 7018that, you know, you keep us in the loop about how your19project plan is starting to -- and we don't need20those, necessarily all the details, but just in terms21of what you are thinking about how to meet the22requirements and going forward.23I've seen another complex application, I24was in operating reactor licensing before this job,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 112where, you know, we've had as many or seven or eight1pre-application meetings to talk about each of the2different technical chapters and what they're going to3be doing to meet the requirements, and you might want4to consider doing something like that just so there is5no surprises.6MS. HAASS: And we have done that in the7past.8MS. HELTON: Yes.9MS. HAASS: Yes, so --10MS. HELTON: Yes.11MS. GAVRILAS: So just one reminder. This12is Mirela again. Just one reminder that these are13estimates, the timelines, and we try to walk you14through the parameters, that impact held with that15estimate that --16So it's almost like you are talking17project management, what we visualize in our mind is18sort of Gantt chart with the end in mind, you know,19how the review of these various activities basically20lead towards the point that which you get an operating21license.22MR. BALAZIK: This is Mike Balazik. Is23there any other questions on the Part 70 piece,24because now we're going to shift to something else?25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 113MR. ADAMS: And now for something1different.2MR. BALAZIK: All right, Al.3MR. ADAMS: So what I'd like to do is, you4know, we have discussed the, you know, general5requirements for licensing, your proposed activities,6you know, we discussed where the current status7review.8Using your cover letter for Part 2 of the9application and the NRC reply I'd like to try to pull10everything together and hopefully the goal here is to11reach a common understanding of how to move forward.12I am, you know, because of the excellent13presentations that came before me, you know, some of14this, you know, some of what I am going to say will be15redundant, but, again, repeating it in the light of16your application requests.17So, next slide. So, you know, here is I18think probably the most important statement from, well19one of the important statements from your cover20letter, that you are applying to the NRC to obtain a21license for a production facility under 10 CFR Part2250.23So, next slide. So I think, you know, we24understand that statement that you are looking for a25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 114construction permit for a production facility, you1know, to dig a little bit deeper that you are looking2for a license to construct a facility where you plan3to conduct activities to separate moly-99 from4irradiated uranium and other byproduct material.5That's consistent with the third6definition of production facility in 10 CFR 50.2. 7There is three basic definitions of production8facility.9One is facilities that are involved in the10formation of plutonium, basically plutonium production11reactors. The other one are facilities that are12primarily separating plutonium, and there is the third13definition which is on the slide, any facility design14or used for the processing of irradiated materials15containing special nuclear material.16(Off the record comments)17MR. BALAZIK: This is Mike Balazik, please18Star 6 your phone to mute it. We can hear some19background conversation.20(Off the record comments)21MR. BALAZIK: This is Mike Balazik. We22are picking up some background conversation. I ask23you please mute your phone, Star 6.24MR. ADAMS: And there is, you know, there25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 115is a safety reason behind the definition and that's1when you are processing irradiated materials2containing special nuclear material basically you are3separating out fission products from irradiated4special nuclear material.5That involves additional hazards from what6you would see in what I would call traditional fuel7cycle facilities, the fact that you are dealing with8irradiated material.9You are dealing with fission products,10radioactive material, gaseous fission products, which,11you know, which creates different accident scenarios12and potential for dose.13So that's sort of the theory and the idea14is once you introduce these irradiated materials that15your intensity of our Part 50 where we are interested16not only in the materials, the licensing of the17materials, but also the licensing of the facility that18contains the materials.19The third definition does contain some20exceptions and you have indicated that you are not21looking to license under any of those exceptions and22those exceptions are that basically your separation is23being done on a laboratory scale, so that's the first24exception.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 116The other one is if you are, that if your1batches are less than 100 grams of uranium then it's2not a production facility. You indicated that your3batches will be greater than 100 grams of uranium.4And the third is that if the irradiated5material that the fission product concentrations and6the plutonium concentrations are less than the cutoffs7in the definition then you are not a production8facility.9So you indicated that you are not looking10to fall under any of those exceptions, which means you11are a production facility under Part 50.12Next. So here is another statement in13your letter to us.14(Off microphone comment)15MR. ADAMS: Oh, I'm sorry. Yes, that's16what it says here. So, I'm sorry, this is our letter17back to you where we completed the review and we agree18that you have an application for a construction permit19for a production facility as defined in 50.2 and20you've met the requirements of 2.101(a)(5) and the21information required by 50.34 and we found your22application acceptable for docketing.23So based on that we are going ahead and24reviewing the application for the production facility. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 117Okay, now Slide 49.1So in your cover letter you discussed your2intent to apply for a single part, a 10 CFR Part 503license. You indicated following NUREG-1537 and you4also referenced the regulations in 50.31 and 50.32.5Slide 50. So just to repeat what 50.316and 50.32 say, so the regulations in Part 50 allows7combining of applications under Chapter 1 of 10 CFR8and Chapter 1 is all of the NRC regulations, so we,9you know, so applications can be combined.10And there is a regulation 50.32 and there11is a parallel regulation in Part 70, 70.21, and they12allow an incorporation by reference information13contained in, you know, previous applications, other14information. The requirement is that the references15are clear and specific.16Slide 51. So your cover letter referred17to NUREG-1537. I assume that when you say NUREG-153718you are referring to the ISG, that augmented 1537 --19MS. HAASS: Correct.20MR. ADAMS: -- which provides applicable21guidance for licensing radioisotope production22facilities and aqueous homogenous reactors, you know,23the guidance on aqueous homogenous reactors isn't24applicable to your proposed facility.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 118NUREG-1537 has a couple of statements that1are applicable to what you are proposing on doing2here. Section 9-5 of NUREG-1537 contains guidance3that materials used in the production facility license4need to meet the regulatory requirements for that5material. In other words, special nuclear material6needs to meet the regulations in Part 70.7NUREG-1537 also says that materials8required to operate the utilization of a production9facility can be included in the license and this10permits the combining of licenses.11Fifty-two. So your cover talked about 12embedded in the 10 CFR 50 license facility activities13under Part 70 and Part 30.14Slide 53. As I mentioned, as discussed in15Section 9-5 of NUREG-1537 the Part 50 license can16include other activities, however, the issuance of a17Part 50 license doesn't automatically include other18activities, other licenses.19For example, you know, Part 70, Part 40,20Part 30 licenses. These licenses are combined only in21the Part 50 license if the applicant has submitted the22needed information and the applicable requirements.23So I think as we said several times, at24this time we don't believe that your construction25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 119permit application has the information required to1grant the additional licenses and I think we're2looking for a better understanding of what you mean by3when you say "embedded activities."4Next slide. So this is an example of a5Part 50 utilization of an operating license. We call6them included activities. What I am looking for is to7understand if our included activities are the same as8your embedded activities.9As you can see in this license the10different licensing clauses. Number 1 on this slide11that is the license for the facility, so that's where12the license is granted for the Part 50 facility. This13is an example of a Class 103 license, which is similar14to the Class license you are looking for.15Where you see the three dots, where you16see the dots there and that phraseology, that just17listed who the licensees were and for this particular18facility there was a very long list of applicants.19And so Number 2 is you see an included20activity, so you can see this is the Part 70 clause so21the included activities to receive, possess, and use22at any time special nuclear material, in this case23it's reactor fuel in accordance with the limitations24for storage and the amounts required for reactor25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 120operation as described in the application.1And you can see in Number 3 there is Part230, 40, and 70 license to receive byproduct, source,3and special nuclear material falls under other uses,4neutron sources for startup, sealed sources for5instrumentation, calibration, radiation monitoring,6fission detectors.7Number 4 is a clause, it's a reactor8clause. It's Part 30, 40, and 70, you can see, to9receive, possess, and use in any amounts is required10in any byproduct source of special nuclear material,11so you can see the included activities.12C is just a reiteration that even though13it's a Part 50 license that the activities under the14other parts, 40, 30, 70, need to follow those15regulations. So that's how these concepts are put in16place in the license.17So, 55. You mention that the RPF will18include the fabrication of LEU targets which will be19licensed under 10 CFR Part 70.20Fifty-six. So, you know, we understand21that, you know, you understand that the fabrication of22targets is under 10 CFR Part 70 as we discussed23several times and this was reflected in our docketing24acceptance letter which stated that staff expects that25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 121and Northwest will submit an application for1fabricating low-enriched uranium targets under 10 CFR2Part 70.3And next is 57 --4MR. FOWLER: So I want to --5MR. ADAMS: Yes?6MR. FOWLER: Al, I I'd just to clarify7that.8MR. ADAMS: Sure.9MR. FOWLER: Part of what triggered a10serious of conversations was the meeting immediately11preceding Thanksgiving in which our internalization of12the communication was a requirement to bifurcate our13application between Part 50 and Part 70.14I was on the phone and I explicitly heard15that there would be a separate requirement for a Part1670 application, where previously we had socialized,17and I'll use the term socialized because it was only18discussed, socialized and put embedded activities, our19assumption that everything would be under Part 50.20So now 2-1/2, three months later I'm21understanding the language differently, which so long22as the information is there it can be either under the2350 umbrella or separate.24MR. ADAMS: It's still that type of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 122license, but, you know, there is choices on how you1put in your application, there choices on how the2license looks.3However, to get from Point A to Point B we4need to follow the regulatory lane for that activity. 5In other words, because I give you a Part 50 license6it doesn't automatically spawn these other licenses.7The Part 50 license by itself is a, you8know, is a license for a very expensive building9without, you know, without the other, you know,10without possession of material that building doesn't11do very much.12So I think that's the nuance that I think13we kind of missed in the conversations back and forth,14and I hope we have clarified.15MS. HELTON: Yes. Just to add to that, I16agree. This is Shana Helton for the phone. The point17I think back at the Thanksgiving meeting that is being18reinforced today is that we need to see something from19you that demonstrates compliance with the requirements20in Part 70.21MS. HAASS: There was --22MS. HELTON: Right. So I think that's --23(Simultaneous speaking)24MS. HAASS: Right, but there was never any25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 123disagreement with that when we were socializing it1when we had originally sent our letter over a year2ago.3MS. HELTON: Right.4MS. HAASS: There was no disagreement on5that, but there was a 1-step process versus a two, you6know, and, you know, there is a nuance and, you know,7we agree with that.8I mean what we need to do today is move9forward and we understand completeness, we understand10compliance, and we will get back with you on how we11plan on dealing with the Part 70, if it's going to be12combined with 50 or not.13MS. GAVRILAS: This is the main objective14of this meeting. We need to make sure that all the15areas where there is uncertainty, where we are not16aligned, today is our opportunity to address them.17You know that's why we exchanged the18topics that we covered today with Carolyn before the19meeting to make sure that everything that we are20presenting here does address your concerns and does21actually get us to the point to which we can align on22the things that have some uncertainty associated with23them.24MR. FOWLER: And so to that point I see25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 124everyone's head nodding that we are now in alignment1with respect to the previous kind of crosswise2communications on 70 and 50 and for that we can3successfully tick off that as we have met that4objective of the meeting.5The second and broader objective of the6meeting was to explore how we ensure that we most7efficiently accelerate the schedule to meet the needs8that we all recognize in the United States.9So I appreciate that we can tick off that10first objective of the meeting successfully.11MR. ADAMS: And I think I have one more12slide. Number, I think Slide 57. So that the current13application that you are not, at this point you are14not seeking an operating license for the proposed15facility.16This is a discussion we would like to have17with you today to the extent, you know, that we can18have it as to what your plans are for submitting your19operating license application because that does20influence timing, that does influence, you know, what21we do on, you know, what we need to do and what you22need to do, too.23So, you know, that's an area that we need24to, that we'd like to understand better for, we're25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 125prepared.1The second point, current application does2not request a license to produce SNM for the3fabrication of LEU targets, I think we beat that one4into submission.5MS. HAASS: Well it doesn't, it's not a6current operating license application.7MR. ADAMS: That's right, it's not.8MS. HAASS: It's Part 70.9MS. HELTON: Right.10MR. ADAMS: Yes. That's right, and that's11a separate point from my first one.12MS. HAASS: Right.13MR. ADAMS: And a facility can have14multiple licenses, that a single building can be a15place of use under multiple licenses.16When I was a licensee my containment17building was a place of use under my reactor license,18it was a place of use under our NRC SNM license, it19was a place of use under a state byproduct license.20The important thing, which I think Dave21and Steve alluded to, is we need to look to make sure22that those multiple activities don't impact the safety23of each other.24MS. HAASS: Yes.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 126MR. ADAMS: So that's the important thing,1but there is no rule that says that, you know, a2certain piece of turf can only, you know, can only be3occupied by one license, and I think that is4consistent with what we have discussed today.5So like I said I think the, you know,6before the day is out we would like to discuss, you7know, what are, you know, your plans for moving8forward with your operating license application for,9you know, for we understand them and we can be, you10know, prepared.11That's it for me.12MR. BALAZIK: All right. Real quick, this13is Mike Balazik again, and I know we have touched on14some of these topics but I just want to reemphasize15them.16On communications, that internal and17external communications is important to support a18quality and timely application review. I just wanted19to go through some of those channels that we have20already set in place.21One that Shana mentioned early in the22meeting about essentially one-stop shopping, that I am23your contact even though you've got, down the road24there is potential licenses, I am your main contact,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 weekly1status calls I'll have Dave and Nancy on those calls.2The next item, clarifying, calls for REIs. 3We've done a couple of those for the environmental and4we plan to continue those for the safety, sharing5those RAIs with you draft form, make sure there is an6understanding, and if there is not, you know, we can7discuss it and even modify the RAIs so that it is8clear.9Since we are discussing RAIs I'd just like10to share one item for thought going forward. Even11though there is no regulatory requirement to update12your PSAR, we've seen a good practice, or identified13a good practice that if you update your PSAR with the14RAIs that that can also lead to a timely review, but15even future steps it will help us, to keep your16updated PSAR.17But realize there is no, you know --18MS. GAVRILAS: I'll just mention one19thing, ACRS. It's easier for the ACRS, we accept your20responses, right, as a supplement to your submission,21they become part, they are docketed and they become22part of the docket.23It makes it much easier when the ACRS24looks at the package to have the package as complete25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 128as possible.1We were talking about places where2efficiencies can be realized, that's a place where an3efficiency can be realized.4MS. HAASS: So a good example is the RAIs5we have received on Chapter 19. We've already updated6Chapter 19. You have not received it, but we have7already updated it.8We actually when we get them we do it9right then and there. I am more than happy to provide10you an updated 19 if you want it right now. I don't11know why we'd need it right at the moment, but we will12be providing a revised PSAR with all the RAIs. It's13already in the plan.14MS. GAVRILAS: That's terrific.15MR. TIKTINSKY: The practice that we find16that works a lot is sometimes, you know, answers to17RAIs are long but changes to the applications don't18necessarily, aren't -- Well you might change one thing19in an application and have a 3-page thing backing it20up.21MS. HAASS: Right.22MR. TIKTINSKY: So at the end of the day,23at the end of the review it's good to have one24application that we know everything that's in the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 129application that we can write an SER against rather1than writing SERs against all these little sort of2sidebar discussions.3So, again, as Mike said it's not a4regulatory requirement but it's certainly an5efficiency that we found in not only 50 reviews but6certainly in 70 reviews also.7MS. HAASS: But remember it's difficult8for us to manage if we don't do that. That makes us9inefficient, so it's only good practice on our part10and to move forward to the operating license.11MR. TIKTINSKY: That could be changed12pages, you know. It doesn't have be, you know, every13time you make something it doesn't need a whole14chapter, it's just whatever related to, you know, the15change from an RAI and is, you know, and you manage it16however you find most efficient.17MR. BALAZIK: All right. Another item,18responsiveness, we've also talked about that,19especially timely response to RAIs and when we share20the draft RAIs if there is something that you see in21there that you can't get in 30 days or a certain22timeframe just let us know.23Let us know that this, hey, we can answer24RAIs 1 through 5 but, you know what, six is going to25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 130take us a little bit longer. You know, we just need1that communication back and forth that there may be2something up there that may take a little bit longer.3Quality of submissions, we also talked4about this, identifying proprietary information,5removing that, and just that answers are complete.6Also, just clarify previous communications7or socializing. We mentioned this earlier that no8regulatory decisions are made in public meetings and9that public meetings are not a substitute for10submittal of information on the docket and also that,11you know, we don't make decisions on our weekly calls.12And, finally, just that the NRC has an13opening policy and if we chose to close a meeting, you14know, it's reserved for information that must be15withheld in accordance with our regulation.16So that's pretty much it for17communications. I don't know if anybody else wants to18add -- Yes?19MR. LYNCH: I just wanted -- I was really20glad to hear that we were able to meet one of your21objectives in terms of licensing, that we have a22shared understanding that additional technical23information is needed for, to meet Part 7024requirements and how you choose to submit that is up25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 131to you and regardless of how it is submitted it's1still the same technical information that we are2looking for. I'm glad we've got that objective met.3I want to make sure that we can also4hopefully meet that second objective that you stated5at the beginning, which was exploring mechanisms to6expedite the review.7I tried making a summary. I think Mike8highlighted them and I just kind of want to read9through those again and make sure that we understand10everything you are looking for and to reiterate our11points that can help facilitate that expedition.12One of those areas we've talked a lot13about, RAIs, trying to reduce the number of rounds of14RAIs and even the total number of RAIs, things that15can go that, the quality of your responses,16completeness and the timeliness, we explore different17ways of communicating that to help facilitate that.18Mike has his weekly status calls. We have19talked about -- and on the status calls we can make,20talk further about if we want to set up standing21public meetings. If that can help we can certainly22get those set up as well.23And broader with communication, you know,24those weekly status calls are good opportunities to25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 132identify problems you see coming down the road that1we, both parties can be thinking about and, you know,2maybe it's not something we address immediately, but3at least we can put them on the list of things NRC4needs to think about and things that Northwest needs5to think about, and they can topics of future public6meetings.7We can also talk about, you know, email8communication works, too, send emails. You can update9and propose topics that we can have on those weekly10calls, topics for public meetings, if we can get11those, and it helps, too, we can discuss ahead of time12before we have those calls.13Al touched on this, also that's important14to us is updates to your schedule. This can be15updates as Mike was talking about with responses to16RAIs.17If it's going to take you a little bit18longer to get certain responses to us work that out19with Mike, let us know what's going on with your20schedule so that we can plan and make sure that we21have people available and ready to review your22responses when they come in.23Also, when you plan on submitting24additional applications, primarily your operating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 133license application, helping us have a good idea of1when that's coming in to make sure that we have people2ready to review it when it comes in.3So letting us know delays that might come4up or if your schedule is getting pushed up, it helps5us align our budget and our resources to make sure6that we are ready for your application.7We also talked about pre-application8meetings. So when you are getting ready to submit9your next application for your operating license we10can have meetings ahead of that submission to make11sure that we have a shared understanding of the12information that's coming in that and have discussions13about that so it helps encourage that a quality14submission comes in for your operating license and15could help potentially reduce that review time as16well.17In talking about the operating license18application I wanted emphasize again, because19ultimately we complete this construction permit review20in our 18 to 24-month timeframe, we're still21anticipating an additional 18 to 24-month review for22the operating license application, and I understand23it's critical that we can get that review done24efficiently as well.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 134So I think for those exploring, those pre-1application meetings can be a good way of getting us2started on that review and knowing when it's coming in3can help us be prepared.4We highlighted following the guidance. 5You can gain insight from NUREG-1537, the ISG, our6standard review plan, so you know exactly what the NRC7is looking for when we review the application that you8sent in, also looking at past applications that have9come in to get ideas of questions we have asked in the10past and the level of detail of information that we11found acceptable in the past.12We also talked about reducing13administrative time so that we don't have time that's14spent with people not doing anything, and I think15that's good and I think those weekly calls, again, are16going to be crucial to reducing that administrative17time for processing.18And Mike highlighted again at the end19updating the application as you are responding to20RAIs. That was my list. Were there other things that21I missed that we can --22MR. ADAMS: There's probably one I want to23touch on. I think I touched on it briefly and that's24the operating license application.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 135The last research reactor that we licensed1submitted a complete application at the construction2permit stage so our review was for both the3construction permit and the operating license at the4same time.5Obviously, that has the potential to, you6know, reduce the review time significantly so that's7why we are interested in knowing what's your timing on8your operating license that, you know, that has an9effect because, you know, the theory is that the10construction permit you've given us so much of, say,11you know, your complete design that you've given us so12much of that design and, you know, there is enough13there to make a decision to allow the facility to be14constructed and then the rest of the details on the15design come in with the operating license that, you16know -- so there is a lot of variability what that,17you know, what those parts, you know, what those two18parts look like.19The first part is here, you know, what20needs to come in to fill and, you know, to fill in the21rest of the information and when that information is22coming in I think is important, you know, in the23discussion of, you know, how to change the, you know,24the timing of this and, you know, not only, you know,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 136talking talk the timing from, you know, the beginning1to you have an operating license.2MR. TIKTINSKY: If I add a little emphasis3from Steve's point on the Part 70 side, you know,4there is many examples of the kinds of the RAIs that5we have asked for Part 70 applications as well as6SERS, so you can sort of see when we write up things7related to 1520 what the kind of things we're looking8for, the kind of questions we had.9And, also, you know, emphasizing of the10use -- You've got multiple things here, the use of11crosswalks, you know, again, the clearer that you can12make it that we understand where the information is13the easier it will be for the reviewers to get the job14done and minimize questions of because we just can't15find information.16MR. FOWLER: So to the list that Steve17summarized very nicely I would add a program/project18management process, just as I manage a program inside19of a private company I have far less insight into the20detailed activities in what's happening at the NRC and21whether we're on track, off track, what are the22constraints, what are the barriers, those kinds of23things.24So a consolidated program project25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 137management structure I think is very, very important1to keep things on track.2MS. HAASS: Yes.3MR. LYNCH: And I think to that, yes, I4think it's very important from both sides to keep each5other updated on where we are at in our reviews and I6think with the calls we can do that.7Also, what we're going to try doing is,8you know, keep you updated on our overall review9schedule. We have this initial review schedule that10we shared here today on our slides, but as things come11up that may necessitate that changing, either12expedited or delays, we need to communicate that to13you as soon as possible, and that's a commitment that14we can make as well.15We are also going to, you'll be seeing16shortly, we're working on developing a public website17that should be going live in the next couple weeks18that you can be able to also have all of your19application data displayed as well, that can be easily20accessed and see our review schedule.21MR. ADAMS: The public --22MS. HAASS: The public would -- Sorry. 23For Northwest Isotopes or for other things as well?24MR. LYNCH: Both. So Northwest specific25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 138and general moly-99.1MS. HAASS: Okay, got it.2MR. ADAMS: And your public information,3not your --4MS. HAASS: I understand.5MR. LYNCH: But, yes, and, you know, as we6continue with the review I'm sure both sides will have7new ideas.8MS. HAASS: Yes.9MR. LYNCH: So chair them and we can10continue to improve.11MR. BALAZIK: All right. At this point12we're a little ahead of schedule. Our senior managers13want to come down for our closing remarks and summary.14The timeframe for that is 2:30, but I15wanted to ask Northwest if they had additional16discussion they want to do in the afternoon on any of17the topics we presented, any topics that we didn't18present today that they would like to discuss in a19public meeting. I've got that scheduled for 1:30 and20lasting about an hour.21MS. GAVRILAS: Yes, I have a suggestion,22that we mull over everything we have heard and perhaps23after lunch we reconvene and that will be the time,24unless you want us to research something over lunch.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 139It's going to be after lunch we reconvene1and we sort of discuss any outstanding items, how's2that?3MS. HAASS: That's fine.4MR. FOWLER: Sounds good.5MR. ADAMS: And another question, is, you6know, giving us information on where you see your7schedule moving forward, you know, especially giving8us the operating license application, is that9something that you are prepared to talk to us today in10this swarm or --11MR. FOWLER: We would certainly be12prepared to respond and provide some answers in a non-13public format, as it's dependent upon a lot of the14questions that were asked of us that are of a15proprietary nature to come up with the anticipated16scheduled.17MR. ADAMS: Okay.18MR. BALAZIK: Okay.19MS. GAVRILAS: Enjoy lunch.20MR. BALAZIK: Yes.21MR. ADAMS: What time --22MS. GAVRILAS: We'll reconvene at --23MR. BALAZIK: Well let's reconvene at 1:3024for discussion of additional topics and then at 2:3025NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 140we'll do the closing remarks.1MS. GAVRILAS: Yes. And we have an2opportunity before the public to --3MR. BALAZIK: Yes, we're going to do that,4too, yes.5MS. GAVRILAS: So we need to stick to the6agenda because --7MS. HAASS: Is there any opportunity for8a non-public portion of this?9MR. BALAZIK: No, there is not.10MS. HAASS: Okay.11MS. GAVRILAS: So we need to stick to the12agenda because the agenda is made available so that13everybody can listen, so we'll just meet back at 1:3014and we'll talk more then.15MS. HAASS: Right.16MR. FOWLER: Very good.17MALE PARTICIPANT: Thank you.18MR. BALAZIK: This is Mike Balazik. We'll19be coming back at 1:30 and we're going on mute until20then.21(Whereupon, the above-entitled matter went22off the record at 11:32 a.m. and resumed at 1:35 p.m.)2324 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 141A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N1(1:35 p.m.)2MR. BALAZIK: Hi, this is Mike Balazik,3and we want to resume the public meeting with4Northwest Medical Isotopes. Right now in the agenda5we have Northwest Medical Isotope topics. If there's6anything that Northwest wants to discuss with the7staff?8MR. FOWLER: We did not have topics in9public form. We'll arrange a separate non-public10meeting to discuss some topics.11MS. GAVRILAS: Mike, you want to talk12about the setting up closed meetings please, because13apparently there was some miscommunication on what14requirements we must need before we can do that.15MR. BALAZIK: Yes, the requirements for a16closed meeting is to submit an affidavit with the17letter, but with the specific topics that are going to18be discussed in the closed forum.19So then what we would do is we would look20at those topics and agree that yes, these are proper21to be discussed in a closed setting vice an open22public meeting.23So in the affidavit that was provided, I24felt that it was very general, and I received some25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 142advice that it did not contain sufficient detail to1close the meeting.2MS. HAASS: And as discussed with you, we3were, we didn't quite know what would be in the non-4public forum because this discussion had to occur and5that's why it was general. So it's not that we didn't6understand, it was because of how the meeting was set7up.8MS. GAVRILAS: I understand. So the other9thing that we tried to see is if it's okay for us to10close a portion of this meeting. So that was the11homework we did during lunch. And we were advised12that that's not okay because the topics need to be13submitted by affidavit. So we tried.14MS. HAASS: It's a catch 22.15MS. GAVRILAS: Yes.16MS. HAASS: But no, we do understand, you17know, the requirements for a non-public meeting. But18we just didn't have enough data to be able to give you19any more specifics.20MR. LYNCH: That's understood. Well21maybe, if we have some time maybe we could use for22time our over here is to maybe make a list of some23action items that we can take for going forward, and24this could include topics for future meetings that you25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 143might like to have, things you would like to see, and1other things you would like to go forward on both2sides that we can take back and then we can get back3to each other on. Does that sound like something you4would like to go over?5MS. HAASS: I would say we can take some6action items. But just as long as we know it's7subject to change because, you know, I still have some8discussions I need to do.9MR. LYNCH: Understood, understood. Yes,10this is not meant to commit you to anything. This is11intended to help us get an idea of when we leave here12today what should we be most focused on, aside from13reviewing your application.14Mike, did you want to lead with any topics15there?16MR. BALAZIK: One thing we've discussed17before, and again stop me if we're going into18proprietary information. But one thing we've19discussed in the past is facility design, final20design.21And what we've talked about earlier are22our resources for future applications, future23submittals. Is it possible we could get some sort of24idea of how far down that path Northwest is?25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 144MS. HAASS: I think we can state that we1are in the process of finishing our final design. But2from a schedule perspective, that would have to be3discussed in a closed session.4MR. LYNCH: Yes, I think the topic from5that is what, something the NRC is interested in6understanding better from you is when will your final7design be complete, and also how do you think you8might consider submitting that because there are9different ways that the final design can be provided10to the NRC.11The final design can be provided as part12of your operating license application, or you can13amend your current construction permit with additional14design information as you finish it.15And however you choose to do that is fine.16But it does help us to anticipate when that17information might be coming in. So that's just, that18is a topic that would be useful for us to discuss in19the future.20MS. HAASS: Well, and I would be21interested, because this is the closed question, what22have you preferred in the past? Would you like to see23it, like, you know, before the operating license24submission with the, maybe the finalization of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 145construction permit.1I mean, I don't know. I mean, I don't2know what's the best timing for you guys I guess I3would ask. And then, you know, we'll try and work4that into a schedule.5MR. LYNCH: I think for us, you know,6we're willing to work with you with whichever way you7would prefer. You know, we haven't done something8like this in a very, very long time. So I don't know9if there's a lot of precedent we can necessarily point10to.11But I think we want to work with your12proposal. And by notifying us when it's coming, we13can make sure we have the appropriate resources14available for that.15MR. ADAMS: This is Al. I think, you16know, the understanding of the timing is important17because we're going to, you know, spend time and18effort reviewing what you've given us.19And if we're 85 percent complete with that20review and all of a sudden we have a whole new bunch21of information, it might be advantageous to finish22that 15 percent, take that licensing action and then23try to reset, try to, you know, blend those two24together and start reviewing sort of an expanded25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 146scope.1So you know, part of it depends on the2timing versus if we're only, like, ten percent into3looking at something and the new information comes in,4then the effort or cost of changing your direction,5changing your scope is minimal. So I think that's an6important solution.7MR. LYNCH: Maybe that's a better way to8capture what we can provide that too. We won't advise9you on which way is better than the other. But we can10discuss, as Al was going to, what potential impacts of11your decisions could be.12MR. BALAZIK: This is Mike Balazik. I13guess another potential item is exemptions. I don't14know if Northwest has looked at any potential15exemptions that could come down the road that we could16be aware of or could prepare for, just kind of another17item that would benefit us in future reviews on18exemptions.19MS. HAASS: Okay.20MR. LYNCH: And even more broadly, just21other licensing actions in addition to your primary22construction permit or operating license, or material23license and application that we might need to consider24and the timing. And for example, that could include25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 147the other research reactors that might be seeking1amendments to support that, knowing the timings that2those licensing actions can help us as well.3MR. ADAMS: Another example would be if4there's any need for shipping packages that would be5unique to what you're doing that, you know, don't6exist. That's another part of NRC and that's, you7know, a discussion that they have their own timelines8for doing that type of work.9MS. HAASS: And we've had brief10conversations with the other organizations, too.11MS. YOUNG: And that's under Part 71.12MR. LYNCH: Another topic that, you know,13that I think we could discuss going forward to our,14we've touched on the topic of potentially setting up15standing public meetings.16Put that on the list of establishing if17that's something that you want to pursue, what you18think appropriate frequency for those meetings might19be, what topics you might want to discuss during20those. I think that, I took that as one of the take-21always I had from earlier today as a topic we should22explore further.23MR. BALAZIK: I guess, this is Mike24Balazik again, for expectations for interactions with25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 148the NRC for the environmental review, we're pretty1much had a set process. I mean, is there any2recommendations on communications that you would like3to see in the future?4MS. HAASS: Just want to make sure that5the RAIs get reviewed prior to going out final to make6sure there's no business sensitive information in7there. If you can at all let me know the possible8timing when that's going to come in, you know, we have9a lot of things going on as well and I need to make10sure our resources are there.11And I know when we get into the safety12aspect it can get more and more difficult, you know,13to get those reviewed, and what resources that means14to us as well.15Also from, Nancy, from your perspective,16I mean, you'll have another public-type meeting within17the NEPA realm. And you know when you're going to be18scheduling that. I know that the City of Columbia was19asking me that question as well.20I just know, you know, they told me they21would really like to help you do that. And I know22last time you guys went and did that, you know,23independently which is fine, but they're also willing24to go help as well. And, you know, you have their25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 149contact information now.1MS. YOUNG: Okay, thank you.2MR. LYNCH: Were there any topics that3you've had in mind in addition to that that you would4like to focus on in the future?5MS. HAASS: No. I think when you start6looking at schedule, the other licensing actions and7the same in the public meetings, that's really where8we want to focus with you guys.9Obviously, the standing public meetings,10you know, we'll assume that there will be some closed11portions of those meetings within that, you know, with12the appropriate documentation, understand that.13MS. GAVRILAS: Mike, you'll need to14elaborate on the process. I think we need the15affidavit with sufficient detail --16(Simultaneous speaking)17MS. HAASS: Oh, that's what I just said.18Right, no --19MS. GAVRILAS: So that's --20MS. HAASS: I said with the appropriate21documentation there would be closed portions as well22because there are certain things that, you know, that23are technically sensitive as well.24MS. GAVRILAS: Sure.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 150MS. HAASS: And so any time we have a1topic, assume that there's going to be some, there's2most likely going to be something business sensitive3in there if it has anything to do with some details of4the facility.5MR. TIKTINSKY: You don't want to forget,6Dave Tiktinsky, the security related information7aspects of public meetings with technical discussions8which is different because that's a different part of9the regulations.10MS. GAVRILAS: Definitely.11MR. TIKTINSKY: So that's always something12we want to make sure that, you know, why we close13meetings related to discussions of that and14information that's the integrated safety analysis or15things that are preferably security related.16MR. BALAZIK: Anybody have anything else?17MS. GAVRILAS: Open it to the public I18would say.19MR. BALAZIK: All right, we can open up to20the public. Actually, I do have one more item. 21Karen, you mentioned resources. Is there the22potential for any impact in the future for Northwest23resources for the review of this application, or even24future applications? There would be no change or any25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 151fluctuations that could potentially happen?1MS. HAASS: Well, there's no change in our2primary subcontractors, no.3MR. BALAZIK: Okay.4MS. HAASS: And they have the people to5support this. But, you know, you still have to6schedule it.7MR. BALAZIK: Yes, no. I understand, I8understand.9MS. HAASS: So yes, but that is not going10to change.11MR. LYNCH: I guess maybe just as a12closing question, do you feel like your expectations13were met today? Did we accomplish what you wanted to14accomplish at this meeting, or at least start moving15in the right direction?16MR. FOWLER: So we had two objectives as17we introduced this meeting from a Northwest Medical18Isotopes perspective. The first was gaining alignment19around or understanding in common of the licensing20application process.21And that one we've I think beaten to death22and are in violent agreement now with an understanding23from both NRC and from Northwest Medical Isotopes of24the options. And the follow up next step on that is25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 152to telegraph to the NRC our intentions. And so I1think from a first objective standpoint, we can2declare success on that one.3The second, and frankly more important one4to the nation and to public health and to public5safety is the speed with which we can accomplish a6successful review within the guidelines and7regulations.8I think this is, we did not have an9expectation that that would be solved in this meeting10today. Our expectation was that we would have a plan11to get to a plan.12What we accomplished in my view today is13I've received more granularity in the schedule14elements from the NRC and the assumptions behind the15schedules, how many iterations of RAIs, how many16iterations for the RCS and so forth.17So I think we now have a framework with18which we can succeed in a productive conversation on19translating the list, Steve, that you've so well-20articulated and added to and convert that into an21operating plan.22And ultimately, what it comes down to to23a company like ours is predictability. Sufficient24granularity in schedules so we know what's next, how25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 153do we assess that each one of those milestones whether1it's on track or off track, and our ability to predict2those next steps, manage accountability, manage3schedule, manage budgets.4The risk to any business, the biggest risk5to any business is uncertainty. And we've been in an6uncertain environment. And this meeting succeeded in7helping to remove some of the uncertainty in terms of8establishing a framework where we can now discuss the9schedule.10And a number of the elements are going to11obviously fall right back on us. We have better12expectations of what the standard is by which we need13to meet. But I think we also can establish a program14management plan so we collectively understand when a15milestone's been achieved and what the next milestone16that we all need to focus on.17MR. BALAZIK: And if there are no more,18this is Mike Balazik, again. If there are no more19questions in the room, first of all I guess I would20like to ask if there's any NRC staff on the phone that21has any questions. And then we'll open it up to the22public.23(No audible response)24MR. BALAZIK: Okay, hearing no questions25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 154from the NRC staff, so now I would like to open up the1phone lines to the public for public comment. Just a2couple of items.3Please, speak one at a time and identify4yourself in speaking. And also if you're5uncomfortable asking a question on the phone, you can6submit your question to me via email at mfb@nrc.gov.7Are there any public comments?8(No audible response)9MR. ADAMS: Can someone verify that the10phones are still open and working?11PARTICIPANT: Yes, the phones are open.12MR. ADAMS: All right, we just want to13make sure silence wasn't something unplugged14somewhere.15MR. LYNCH: Thanks, Jenny.16PARTICIPANT: We're here, thank you.17MR. BALAZIK: All right. So I think we18are, are we expecting Bill and others to join us19later?20MS. GAVRILAS: Yes. I think we'll adjourn21until 2:30 when we have an opportunity to interact22with two office directors. I think at least one23office director, perhaps two. And certainly my boss,24Lawrence Kokajko is going to join us.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 155I don't know if Craig who is the acting1director in Shana's organization is also going to join2us. So you'll have an opportunity to reiterate, we'll3reiterate our action items and you'll have an4opportunity to interact with them.5MS. HAASS: And which office directors,6potentially?7MS. HELTON: Bill Dean.8MS. GAVRILAS: Bill Dean, our director is9coming for sure.10MS. HAASS: Okay.11MS. GAVRILAS: And his deputy might come12as well.13MR. ADAMS: So we're going to go mute on14the phones until 2:30 and then we'll be back on.15(Whereupon, the above-entitled matter went16off the record at 1:54 p.m. and resumed at 2:33 p.m.)17MR. BALAZIK: Mike Balazik, we're resuming18the public meeting. Right now we're toward the end of19the meeting. And we just want to real quickly go20through some closing remarks. Oh, I'm sorry.21Bill Dean, Office Director of NRR is22joining us, and Michele Evans has also joined us, and23Lawrence Kokajko has also joined is. He's the24Director of DPR, for our members on the phone. All25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 156right.1(Off microphone comments)2MR. BALAZIK: Okay, can we just go through3everybody, identify themself that's new to the4meeting?5(Simultaneous speaking)6MS. EVANS: Sure. Michele Evans, Deputy7Director of NRR.8MR. KOKAJKO: Lawrence Kokajko, Division9Director, Division of Policy and Rulemaking.10MS. MARSHALL: Jane Marshall, Deputy11Director, Division of License Renewal, NRR.12MR. ERLANGER: Craig Erlanger, Acting13Director for the Division of Fuel Cycle Safety14Safeguards and Environmental Review.15(Off microphone comments)16MR. BALAZIK: Okay. You want to start?17MS. GAVRILAS: Yes, so we had what I would18qualify as a productive meeting this morning. And I'm19going to ask the Northwest Medical Isotopes to bring20their own clarification.21Mike and Steve prepared a few summary22points of the meeting that I'll ask them to go23through, a couple of action items. And then I know24that Bill would like to engage you in some25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 to1summarize.2MR. BALAZIK: You going to go through the3points, Steve? You have the points?4MR. LYNCH: Whatever you would like.5MR. BALAZIK: Yes.6MR. LYNCH: I can go through it.7MS. GAVRILAS: One of you two needs to do8the summary of this morning, please, and the action9items. Thank you very much.10MR. LYNCH: All right. So I guess for11everyone's benefit that's in here that was not here in12the morning, we had two main objectives that we had13set out to accomplish as identified by Northwest, and14those were to talk about the licensing approach for15the facility. And then the second item was to talk16about mechanisms to expedite the review of Northwest's17construction permit application.18For the first point, we reached agreement19and a shared understanding that there is additional20technical information that Northwest will need to21provide to meet the Part 70 requirements in 10 CFR.22Whether that's submitted as part of their23operating license or as a separate application is up24to them, but we are in agreement that regardless of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 158how the information is packaged, we understand on both1sides what technical information needs to be provided.2Is that correct?3And then the second point for mechanisms4to expedite the review, we went over a number of items5that we can do on both sides to make sure that we6review their construction permit application as7expeditiously as possible.8One of the items we discussed were9approaches to request for additional information to10limit both the total number of RAIs that we asked and11the number of rounds that we go through.12Ways that we can address that are ensuring13that the NRC is clear in the questions that we ask and14making sure that we have phone calls with Northwest15when those RAIs are issued to make sure they16understand the question that we are asking.17And also when they are getting prepared to18submit their responses, to have additional calls. 19That may take the form of a public meeting if we need20to discuss technical details, or it could be shorter21clarification calls to make sure that they're on the22right track.23Again, the goal of that is to make sure24that we have a shared understanding of the NRC's25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 159expectations and what Northwest's understanding of our1expectations is. We also emphasize that quality and2completion of those RAIs is important as well.3This fed into a larger discussion of4appropriate methods of communication during the review5process. We have already established weekly calls6following the docketing of the application that Mike7and others as needed sit on with Carolyn once a week8to discuss the status of the review and then the other9administrative details as necessary. And that's10consistent with our practices for other reviews11throughout the agency.12MR. DEAN: So how long has that been going13on? For how long?14MR. LYNCH: Since January 12th.15MR. DEAN: Okay, all right.16MR. LYNCH: So right after we concepted17the review and everyone got back from the holidays.18MR. DEAN: Okay.19MR. LYNCH: We discussed the importance of20staying up to date on schedule, both from the NRC's21perspective as we're doing our review to make sure we22communicate how we're progressing towards milestones,23and also to get updates from Northwest on24anticipations of when, you know, if they have any25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 160delays on the current application, responses through1RAIs, and just updates of when they anticipate2submitting future applications such as their operating3license application.4We discussed, as far as the information at5Northwest provides what's the threshold of what's6acceptable to the NRC, we went there already following7our formatting content that I had provided in NUREG81537 and the ISG augmenting NUREG 1537.9And as far as the threshold that we set10for the information that we're doing our review, we11told them that when we do our review we use our12standard review plan that is publically available, and13that is the threshold we set for the information that14we are looking for in their application.15And to maximize the efficiency of our16review, the clearer it is to us that they have17addressed the acceptance criteria in the standard18review plan, the easier it is for the NRC to move19forward quickly.20MR. DEAN: Both for the Part 50 and the21Part 70 aspects?22MR. LYNCH: Yes, yes. We discussed the23guidance for both aspects that they can use.24MR. DEAN: Okay.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 161MR. LYNCH: We also talked about the1importance of reducing administrative time for2processing on the NRC side and also preparation of3documents on Northwest's side. The goal is through4our talks to make sure that there isn't significant5debt time where either side is sitting, not doing6anything and just waiting.7And this feeds into general program and8project management on both sides and making sure that9we are identifying clear goals towards working towards10the identified milestones that we have in the project.11And the last thing that we went over, or12I shouldn't say last thing, I could think of two more13things. Looking at past precedents, we have examples14of reviews we have done in the past, most recently15with SHINE, there are transcripts available from ACRS16meetings that they can look through as we go through17ACRS to help improve their preparation for those18meetings.19Also, they can get a sense from looking at20these applications for what the NRC has found21acceptable in the past and types of RAIs we've asked22in the past and what types of responses we're looking23for and similarity of reviews.24As we get ready for their operating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 162license application, one way we can get ready for that1is we explore the possibility of having pre-2application meetings to discuss the technical problems3or issues that may come up that we need to explore4before the application is submitted that there may be5questions on.6And also with the current construction7permit application, we talked about efficiencies that8can be gained from maintaining that document up to9date as they respond to RAIs and information in their10current PSAR needs to be updated, that they can11provide updates to that.12At times it will work out with Mike, it13will make it easier for our reviewers to have a single14document to look at that has all of the updated and15completed information, and also as we go forward to16the ACRS and with the mandatory hearing.17We also discussed earlier today the status18of our review and our plans going forward. So with19all of that, I think with that I think with those20topics, that addressed the second main point of21talking about ways that we could expedite the review. 22I think that covers it for that second point.23MR. FOWLER: You did a good job, thank24you.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 163MR. LYNCH: And then between 1:30 and 2:001we came up with a list of action items to take away to2come back to in the future. The first of these was3setting up a, exploring the possibility of setting up4standing public meetings.5And this, Mike and Northwest will work6together on this to see if it's needed. But the idea7behind this is to cut down on some of that8administrative time.9If we see the need to discuss significant10technical information, most likely related to RAIs on11a regular basis, instead of noticing public meetings12every time we need to have one, we set up a frequency13maybe once a month, once every other month, something14that's agreed upon between both parties. That was15identified as a topic worth exploring in the future to16see if it could help in the review.17The next action item we had was in a18future meeting discuss when the final design for19Northwest will be provided to the NRC. This includes,20you know, the final design could be submitted as part21of the operating license application, or it could be22submitted while we are still reviewing the23construction permit.24And understanding Northwest's intent will25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 of1that, we can discuss with them in the future the2impact of their decision to go forward one way or3another, without recommending a preference.4The third item that I had here was the NRC5could benefit also from understanding any additional6licensing actions that Northwest may request in the7future.8This could be related to transportation of9materials, any exemptions that they foresee needing10for their current licensing requests or future11licensing requests. Also, license amendments that12existing research reactors might need in order to13support the radiations of their manufacture targets.14Fourth item that we had as a take-away was15making sure that we have clear expectations on both16sides. This has to do with, mostly with requests for17additional information.18Northwest would like to be able to review19drafts of the RAIs for potential proprietary20information before they're issued. And also to the21extent practicable, we would like notifications of22when the RAIs are getting close to being issued so23that they can make sure that their resources are ready24to receive any begin working on responses to them.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 165Also, Northwest offered that for future1public meetings, that we have it out in Missouri, that2the local government there is willing to work with us3in getting that set up in the future as well.4And I think the last thing, the last5action item I had on here was on both sides, and it's6kind of relates to everything else we've just been7talking about is just having clear communications on8both sides of schedule, NRC making sure that we9identify the milestones that we're working towards and10our progress towards that and Northwest, again letting11us know their schedule and any impacts they may have.12MR. DEAN: Okay, is that it?13MR. LYNCH: Yes.14MR. DEAN: Okay. Good. Sounds like you15guys had a productive meeting. So appreciate you guys16coming here from Oregon? Both of you from Oregon?17MS. HAASS: The northwest.18MR. DEAN: Northwest? Okay. Go Ducks. 19No?20MR. FOWLER: Well, we have Ducks and21Beavers.22MR. DEAN: Okay, all right. Depends what23part.24MS. HAASS: I'm a Husky.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 166MR. DEAN: Okay, depends on what part of1the state that you're from. Well, so I appreciate you2guys coming in. And it sounds like it was very3productive and useful meeting.4I know that you all were here not too long5ago and had expressed some concerns with some of our6commissioners and some of our senior management about7the process and not having a good understanding of the8process.9And so it sounds like, and I certainly10would be interested in your all's perspective that11today's meeting helped move us forward in terms of12establishing better communication and better13understanding of what you can expect from us, but also14things that we hope that we can engender from your15side of it because I view, personally I view this16process, and it's a big deal right, moly-99 is a big17deal for this country.18And so you guys are pursuing something19that is important to public health and safety which is20obviously the ultimate mission or objective of the21NRC, that we do it in a collaborative way and not in22any sort of adversarial way.23I know there's always just sort of dynamic24in terms of a licensee or an applicant and the NRC and25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 167we ask a bunch of questions, you got to give us a1bunch of answers.2But in reality, I think we're all striving3to get to the same point which is can we get licensed4for construction and utilization a facility that can5be useful in providing moly-99.6So in that regard, I think what we have is7a very common end point. So I guess I would be8interested in your all's perspective in terms of how9you thought today's discussion went, were we able to10address perhaps some of the concerns you've had in the11past.12And if there's still some open questions,13you know, Steve went through a list of action items,14but are there still some things that you all have in15your mind that are kind of open or areas that we ought16to consider.17Like, one thing I didn't hear in your18discussion was the benefit of, you know, sometimes19when we get an RAI process there's this kind of20throwing stuff over the transom and then you all21develop and throw it back over the transom.22And sometimes we can make better progress23if we do things like, well we call them audits, right,24but we actually either send people to wherever the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 168information is and have face to face meetings as1opposed to going into a sort of a writing campaign. 2Is that something you guys talked about was the audit3process?4MR. LYNCH: We did not talk about that5today. But we have had an audit on the environmental6side as they were preparing information.7MR. DEAN: Okay.8MR. LYNCH: So we have gone through that.9MS. HAASS: And we've had the discussions10in the past and we know that it's one of the tools we11can use to make things more efficient.12MR. DEAN: Okay. Okay, good. Okay, and13then the other one was I didn't hear anything about14would it be beneficial for example to set up an15electronic reading room where you guys have materials16that you developed that are accessible to our staff17through some sort of portal or whatever so there's18more ready actions instead of you guys having to mail19them.20MS. HAASS: Well, and we are setting that21up. There's always technical difficulties because you22guys have some requirements and you know what they23are, you know, about the encryption and the passwords24and this, that, and the other. And so those things25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 169are getting set up.1MR. DEAN: Okay. I think we've had some2success where the licensee sort of maintains that and3then we just get a password for access and it helps4maybe avoid some of those, you know, red tape things5that we tend to have as a bureaucracy.6But anyway, so we certainly, that would be7something that could hopefully improve or increase8efficiency.9MS. HAASS: Well, and another thing that10could help efficiencies is I know we talked about it11a bit offline just standing here. But, you know, some12granularity on how, what RAIs are going to be coming13because you're not going to throw all of them over at14once.15You may be doing them based on subject16matter areas and, you know, getting a better17granularity in a schedule like that because that helps18both your resources and ours and us to be more19efficient in responding as well.20MR. DEAN: So I was pleased to hear that21you guys have set up weekly calls. So hopefully22you're finding those beneficial. I know that we do in23terms of being able to ferret out those sort of24things.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 170And I don't know whether, have you guys1kind of developed sort of a standing agenda, or has it2kind of been sort of ad hoc? I would assume that3there's things that week to week that you're going to4want to talk about.5MS. HAASS: Yes, there's definitely a6standing agenda. But then, you know, you've got7things come on and off that agenda as well.8MR. BALAZIK: And this is Mike Balazik. 9And sometimes we'll share stuff earlier in the week10that is to be a great topic to have on that weekly11call so that we can take one level deeper into it if12it's just Kevin and I talking. Sometimes we'll move13stuff on a weekly call.14MR. DEAN: And also to make sure we get15the right people there.16MR. BALAZIK: Correct.17MR. DEAN: Okay, all right. So that's18good. I think that's a great initiative to do that.19So at least what I'm hearing was that it was a20constructive, worthwhile meeting, is that --21MR. FOWLER: I do believe it was a very22productive meeting. And for those of you who attended23our meeting about a month ago in the Executive24Director's office, we understand that the NRC has a25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 171mission for public health and takes the production1capability this country for moly-99 very seriously.2We understand that, appreciate that,3respect that. I hope that you all also understand4that we take our mission of providing that secure,5reliable supply of moly-99 in the United States6extremely seriously. That was part of the intent with7the Executive Director's office when we were there.8We also wanted to communicate that while9we all know that this is a public health potential10issue, sometimes hearing directly from the feet on the11street, the constituents and our supporters and12investors are public healthcare institutions serving13tens of millions of people across the United States.14And so to hear directly from the CEOs of15those public health services organizations I think is16important to remind us of just how real the mission17that we share collaboratively really is. It's18extremely important.19This meeting stemmed as a follow up to a20couple of outstanding items from the initial meeting,21the first being clarification on our licensing22application submission process. And that one, declare23victory.24We understand it is in good shape. We25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 172all, I think, are in agreement that we understand1where to go from here. We will need to telegraph our2approach so that the NRC can anticipate. But we're3all on common understanding of that first objective. 4So declare success on that one.5The much broader one is how do we meet the6needs of this country in a timely fashion. And what7we achieved today was establishment of a very strong8framework that we now understand better how the9schedule of review is constructed and built within the10NRC.11That helps tremendously because we can12look at the assumptions, we can compare the13assumptions, and we can begin to manage this as a14project. It's likely, in fact it's assured, that15we'll need a number of follow up conversations to16translate that framework into a plan that can be17project managed, and we've left with a joint objective18to do exactly that.19And Steve did a great job of summarizing20some of those actions. And so we can't yet close with21full success the second objective on accelerate the22schedule to degree possible.23I think we have a pathway to continue a24process to get to a mutually agreed schedule, one that25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 173we can both bring back to our supporters and manage1against with expectations, identify milestones,2identify where we've deviated from milestones, and3take remedial actions as appropriate.4And that, to me, is a successful day spent5here in the DC area.6MR. DEAN: Well good, I'm pleased to hear7that, Nick, in terms of your perspective on how the8meeting went because certainly this was one that I9felt was very important, you know, the fact that10Michele and I and Lawrence wanted to make sure that we11touched base with you all before you left to make sure12that the meeting met your objective was very important13to us.14And so that gives me great confidence that15we did have a constructive and productive dialogue. 16But we need to sustain that.17MR. FOWLER: Exactly right.18MR. DEAN: And I like some of the things19you guys have talked about in terms of potential20action items. I was interested a little bit more in21exploring the topic that Steve raised that when we22have meetings in Missouri and the engagement of the23local government.24What's the sort of the rationale, what are25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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,1but I mean --2MR. FOWLER: That was in specific3reference to any ongoing environmental public meeting4needs where we've had one meeting in Columbia already.5If there were needs for others, the City of Columbia6and the County of Boone County in Missouri have7offered any and all assistance to the NRC if any is8requested.9MR. DEAN: Okay.10MR. FOWLER: They stand ready to help.11MR. DEAN: Okay.12MR. LYNCH: And this is consistent with13previous reviews, even for the SHINE review we've gone14out for the environmental meetings generally, send an15email to the city manager and county executives, let16them know we're coming, offer any government-17government interaction they would like to better18understand our process and work our way forward.19MR. DEAN: Okay.20MR. LYNCH: So that's all consistent.21MR. DEAN: Okay. Good, okay. Good.22MS. HAASS: And there's also the ability23that they would help you coordinate to make things24easier, you know, on you. They have the facilities25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 175available.1MR. DEAN: That's great.2MS. HAASS: And so, and they want to be3involved.4MR. DEAN: Super. Okay, that's wonderful.5Okay, good. Okay. Anything for me that you would6like to convey beyond what you already have?7MR. FOWLER: Well I think that again,8we've had a successful meeting. I think in other9strategic partnerships that are collaborative in10business that I run, we have not only program11management at the level of checking all the boxes on12the program plan, we have a refreshment at this level13to ensure that both parties are in fact comfortable14with progress and resource assignments and strategic15alignment as we move forward.16Certainly it doesn't need to be a monthly17meeting at this level, but probably on a quarterly or18semi-annual basis it would make sense for us to touch19base at this level to ensure that we're both meeting20each other's expectations of moving forward.21MR. DEAN: Okay. And you're comfortable22with the 12 to 15 to 1 ratio of members of the NRC? 23Is that okay? You're comfortable with that ratio?24MR. FOWLER: Well, come out our way and25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 176we'll reverse the ratio.1MR. DEAN: Good, good. Well, anything2else that you would like to achieve today?3MS. GAVRILAS: No. I think we met their4objectives and we have a good meeting.5MR. DEAN: Okay, good. Good. All right,6so who do I point to in terms of is it Mike is the7sort of individual that I want to point to as8somebody, for SHINE I went to Steve a lot. So is9Mike?10MS. GAVRILAS: So that was one of the11issues we discussed that even though there are12multiple organizations involved in the review, there13will be one voice for the NRC and that voice is Mike.14MR. DEAN: Okay, good. Okay, good. 15Super. Okay, anything else? Excellent. Okay.16MR. FOWLER: Finished the agenda on time.17MR. DEAN: Safe travels. Safe travels18back.19MR. BALAZIK: This is Mike Balazik. I20just want to thank everybody for attending the meeting21today. And we're going to close the bridge line. 22Thank you.23(Whereupon, the meeting in the above-24entitled matter was concluded at 2:58 p.m.)25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 Official Transcript of ProceedingsNUCLEAR REGULATORY COMMISSIONTitle:Meeting with Northwest Medical IsotopesDocket Number:Location:Rockville, MarylandDate:Thursday, February 18, 2016Work Order No.:NRC-2177Pages 1-176NEAL R. GROSS AND CO., INC.Court Reporters and Transcribers1323 Rhode Island Avenue, N.W.Washington, D.C. 20005(202) 234-4433 1UNITED STATES OF AMERICA1NUCLEAR REGULATORY COMMISSION2+ + + + +3PUBLIC MEETING WITH NORTHWEST MEDICAL ISOTOPES, LLC4+ + + + +5THURSDAY,6FEBRUARY 18, 20167+ + + + +8ROCKVILLE, MARYLAND9+ + + + +10The Public Meeting commenced in Room O-1116B4, One White Flint North, 11555 Rockville Pike, at128:30 a.m., Mike Balazik, Project Manager, presiding.1314NRC STAFF PRESENT:15LAWRENCE KOKAJKO, Director, Division of Policy and 16Rulemaking, Office of Nuclear Reactor 17Regulation18WILLIAM DEAN, Regional Administrator, Region I 19CRAIG ERLANGER, Acting Director, Division of Fuel 20Cycle Safety, Safeguards, & Environmental 21Review, Office of Nuclear Material Safety and 22Safeguards 23MICHELE EVANS, Deputy Director, Office of Nuclear 24Reactor Regulation25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 2JANE MARSHALL, Deputy Director, Division of License 1Renewal, Office of Nuclear Reactor Regulation2MICHAEL BALAZIK, Project Manager, Division of Policy 3and Rulemaking, Office of Nuclear Reactor 4Regulation5ALEXANDER ADAMS, Chief, Research and Test Reactors 6Licensing, Office of Nuclear Reactor 7Regulation8MIRELA GAVRILAS, Deputy Director, Division of Policy 9and Rulemaking, Office of Nuclear Reactor 10Regulation11SHANA HELTON, Acting Deputy Division Director, 12Division of Fuel Cycle Safety, Safeguards & 13Environmental Review, Office of Nuclear 14Material Safety and Safeguards 15ROBERT JOHNSON, Chief, Fuel Manufacturing Branch, 16Office of Nuclear Material Safety and 17Safeguards 18STEVE LYNCH, Project Manager, Research and Test 19Reactors Licensing Branch, Office of Nuclear 20Reactor Regulation21NANCY MARTINEZ, Environmental Project Manager, 22Office of Nuclear Reactor Regulation 2324 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 3DAVE TIKTINSKY, Project Manager, Fuel Manufacturing1Branch, Office of Nuclear Material Safety and 2Safeguards34ALSO PRESENT:5NICHOLAS FOWLER, Chief Executive Officer, NWMI6CAROLYN HAASS, Chief Operating Officer, NWMI78 910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 4T-A-B-L-E O-F C-O-N-T-E-N-T-S1Page2Opening Remarks by NRC Staff3Michael Balazik..............64Mirela Gavrilas..............135Shana Helton...............146Opening Remarks by Northwest Medical Isotopes7Nicholas Fowler..............158NRC Licensing Processes9 10 CFR Part 50, General10Steve Lynch................2011 10 CFR Part 51, Environmental12Nancy Martinez..............3613 10 CFR Part 50, Construction & Operating License14Steve Lynch................4215NRC Licensing Process, Part 7016Dave Tiktinsky..............9017Licensing Review Request (NWMI licensing request and18NRC understanding of request - NRC/NWMI)19Al Adams................1132021 22 23 24 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 5Communications (NRC/NWMI)1Michael Balazik.............1262Steve Lynch...............1303Al Adams................1344Dave Tiktinsky.............1355NWMI Topics for Discussion..........1416Closing Remarks/Summary............1557Adjourned...................1768910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 6P-R-O-C-E-E-D-I-N-G-S1(8:33 a.m.)2MR. BALAZIK: All right, good morning. 3I'd like welcome everyone in attendance today. My4name is Mike Balazik. I'm a project manager in the5Division of Policy and Rulemaking at the NRC.6Northwest Medical Isotopes has agreed to7meet with the NRC staff today to discuss licensing for8their radio isotope facility.9This is a Category 1 public meeting10conducted in accordance with the Commission's Police11Statement on enhancing public participation in NRC12meetings. As such is intended to be a dialogue13between the NRC and Northwest Medical Isotopes14concerning topics related to licensing in Northwest15Medical Isotope facility project.16The public in invited to observe the17meeting and will have the opportunity to communicate18with the NRC staff after the business portion of the19meeting, but before the meeting is adjourned. 20Northwest may respond to comments or questions from21the public but is not obligated to do so.22When we go through the introductions I ask23everybody identify yourself and your affiliation. 24There's a sign-in sheet that may be moving around the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 7room right now. I ask everyone sign in. Yes, thank1you.2If you wish to provide any comments on the3meeting, I can provide you a meeting feedback form. 4Or you can also go to the public meeting cite and do5it electronically.6This meeting is scheduled to last till7approximately 3:00 p.m. I'd like to emphasize that8this meeting is primary for the NRC to discuss general9licensing processes and reviews, the NRC regulations10and guidance with the Northwest. There are no11regulatory decisions will be made at this meeting.12Also, as a reminder, this meeting is being13transcribed today. And for everybody on the phone,14the slide presentation is available. It's publically15available. And I'm going to provide the NO number16right now for everyone. The number is ML16048A, as in17Alpha, 554.18Does anybody on the phone need that19repeated? All right, I'm not hearing any.20(Off record comment)21MR. BALAZIK: All right, I'll continue on. 22A meeting summary will be made publically available23within 30 days of this meeting.24Before we begin, a couple of items I'd25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 8like to mention. First of all, please limit1interruptions. Silence your cell phone and please2keep side conversations to a minimum.3I ask you speak one at a time. And4individuals on the phone, please mute your phone5unless you're going to provide any comment.6Also, please identify yourself when you7speak so people on the phone knows who's speaking. 8And again, submit any questions or comments to me at9mfb@nrc.gov.10Next I'd like to remind you that you're11within a NRC controlled space. Should there be an12emergency all occupants should begin to calmly13evacuate using the nearest stairwell to exit the14building.15All visitors will be escorted by the NRC16staff. Disables persons, who due to health reasons17feel they cannot safety walk down the stairs to18evacuate, may use the elevators. Exit through the19nearest door and then go to the pause area in front of20One White Flint and report their presence with the21guard.22So you experience, observe anyone with a23life threatening medical complaint while evacuating,24call 911 and report your location and nature of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 9emergency.1Also, if you need to use the restroom,2you'll need to be escorted.3All right. So let's now run though4introductions. I'd ask everyone to speak loudly so5people on the phone can here you. And let's start6around the table.7As I said earlier, my name is Mike8Balazik. I'm a Project Manager in Division of Policy9and Rulemaking.10MS. MARTINEZ: Good morning. I'm Nancy11Martinez, NRC Environmental Project Manager.12MS. GAVRILAS: Mirela Gavrilas, Deputy13Director, Division of Policy and Rulemaking in NRR at14the NRC.15MR. LYNCH: This is Steve Lynch. I'm a16Project Manager with Research and Test Reactors.17And real quick, before we go on with the18introductions, if you are participating on the phone,19could you please put your phone on mute? We're20getting a lot of feedback in the room here. Thank21you.22MR. ADAMS: Al Adams, Chief of Research23and Test Reactor Licensing, NRC.24MR. TIKTINSKY: Dave Tiktinsky, Project25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 10Manager of the Field Manufacturing Branch in Office of1Nuclear Material Safety and Safeguards.2MR. JOHNSON: Good morning. Robert3Johnson, Fuel Manufacturing Branch Chief, NMSS.4MS. HELTON: Shana Helton, Acting Deputy5Division Director at Fuel Cycle NMSS.6MR. FOWLER: Nick Fowler, the Chief7Executive Officer of Northwest Medical Isotopes.8MS. HAASS: Carolyn Haass, Chief Operating9Office, Northwest Medical Isotopes.10MS. KEIM: Andrea Keim, Vendor Inspection11and Quality Assurance, NRR.12MR. MATULA: Tom Matula, NMSS, Project13Manager.14MR. MORRISSEY: Kevin Morrissey, Fuel15Cycle Review.16MS. ADAMS: Mary Adams, Fuel Cycle Safety17and Environmental Review.18MS. LONDON: Lisa London, Office of19General Counsel.20MS. BIELECKI: Jessica Bielecki, Office of21General Counsel.22MR. LINDELL: Joseph Lindell, Office of23General Counsel.24MS. KANATAS: Catherine Kanatas, Office of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 11General Counsel.1MS. YOUNG: Mitzi Young, Office of the2General Counsel.3MS. TRAN: Linh Tran, Research and Test4Reactor Licensing Branch, NRC.5MR. ALLEN: Eben Allen, Research and Test6Reactor, Project Manager.7MR. BALAZIK: This is Mike Balazik, please8mute your phones. Somebody's got an open line and9they're speaking and we're hearing you in the room.10MR. LYNCH: Star 6.11MR. DANNA: Jim Danna, NRR, Division of12License Renewal.13MR. MILLER: Chris Miller, Office of14Nuclear Reactor Regulation. And I'm the Director of15the Division of License Group.16MR. ISAAC: Patrick Isaac, Research17Reactor Oversight Branch.18MR. BALAZIK: All right, this is Mike19Balazik again. Let's go to the phone line. I ask20individuals to identify themselves.21MR. RODRIGUEZ: Michael Rodriguez, NRC,22NSIR EP.23MR. FLAGG: Michael Flagg, University of24Missouri Research Reactor.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 12MS. MCCULLOUGH: Kara McCullough, NSIR,1NRLB.2MR. BERICK: Dave Berick with Senator Ron3W.4MS. RIVERA: Alison Rivera, NSIR EP.5MS. BANERJEE: Good morning. Maitri6Banerjee, ACRS Staff.7MS. WEIL: Jenny Weil, Congressional8Affairs.9MS. FRAZIER: Andy Frazier, Region III10Office.11MS. MOSER: Michelle Moser, Environmental12Energy Staff.13MR. BARTELME: Jeff Bartelme, SHINE14Medical Technologies.15MR. NAQUIN: Ty Naquin, NMSS, Fuel16Manufacturing Branch.17MR. TEAL: Charles Teal, NSIR Fuel Cycle18Transportation Security Branch.19MR. FOLK: Kevin Folk, NRC Environmental20Staff.21MR. WEBER: Carl Weber, NRC, Office of New22Reactors.23MR. BALAZIK: Is there anybody else on the24phone that wishes to identify themselves? Okay, I'm25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 13hearing none.1So now I'd like to turn it over to Mirela,2who would like to provide some opening remarks.3MS. GAVRILAS: Thank you, Mike. Welcome4everyone. I want to start out with a very high level5statement which is, that we, the Agency, recognize the6importance of establishing a reliable domestic supply7of molybdenum-99.8And as such, we recognize our role to9support that national effort. So you will see, you10will hear today about what we do and how we do it and11why we do it.12And you'll also hear, you see already that13the room is filled with technical experts and with14regulatory experts who are here to answer all your15questions. Because the main objective of this meeting16is to obtain clarity in our communications.17It is very important to us that we hear18each other correctly. Because we realize that every19time we take time out to clear out misunderstanding,20we spent resources and time that would be better spent21moving the review and the effort forward.22So our main objective today is basically23to discuss the topics that we agreed with Northwest24Medical, should be discussed today. And we want to25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 14have open dialogue. So please ask questions at any1time.2Again, we have the technical and the3regulatory experts in the room to address your4questions. So we want to make sure that at the end of5the meeting, we're aligned in terms of our6understanding of where we are in terms of the review7of the construction permit that's in front of us now,8as well we the preview of the operating license that9is still to come.10So with that, I'm going to pass it to11Shana who is going to give a couple of additional12opening remarks.13MS. HELTON: Thanks, Mirela. I agree with14Mirela's points. I can't emphasize enough the need to15obtain clarity on both sides, so that we can have an16efficient, effective licensing path forward.17And to that end, I just want to say, that18while multiple offices are involved with this review,19we do act as one NRC. You will hear from us with one20voice.21Mike Balazik will be your primary point of22contact. So you don't have to worry about trying to23correlate between different offices.24And just as we go through this, one point25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 15that I wanted to emphasize is that for each1application that we receive as an Agency, not just in2this area of medical isotopes, we review each3application based on its merits.4So really we need to look at what's before5us today. And as we go through the construction6permit, that will be one aspect of the review.7One goal, on our end, is to really gain8clarity on the nature of any of your future9submittals, since you've indicated that some of your10activities would be regulated under Part 70 and under11Part 30. So I look forward to learning more about12that path forward as well.13So with that, you know, I just look14forward to having a good meeting. Thank you for15coming here today. And for everybody on the phone.16MR. BALAZIK: This is Mike Balazik. Thank17you, Shana. Now I'll turn it over to Northwest18Medical Isotopes for some opening remarks.19MR. FOWLER: Well, and I would add my20thanks to everyone that's assembled here. In that we21all understand the importance of serving a reliable22and secure supply within the United States for moly-2399.24And we met with the executive director and25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 16his direct staff and a number of folks who are in this1room a month ago. And we believe, Northwest Medical2Isotopes believe, it was an excellent conversation. 3Part of a long-term relationship building exercise to4make these conversations as productive as possible.5We invited with us, a couple of people to6provide perspective. One of whom was the chief7executive officer of a leading healthcare services8provider in the United States.9And we all recognize the need for this10reliable supply of moly in the United States. But11sometimes hearing it from a healthcare services12provider that's responsible for millions of people,13who can provide that direct testimony of what it means14when there are shortages, is important. And we15thought that important to provide that direct16perspective into the executive meeting a month ago.17We also invited Mallinckrodt to speak on18the state of the supply chain. And what is coming19forward in the near future and the potential fragility20of that supply chain that really puts a point on why21these activities that are before the NRC are so22important.23We then had a fruitful discussion on two24questions that Northwest Medical Isotopes had25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 17specifically. And we hope that this meeting today1directly addresses those two questions as follow up to2that meeting.3The first had to do with the licensing4approach as our activities do incorporate both Part 505and Part 70 activity in our intended operations.6And the other was recognizing the need for7this domestic supply, exploring mechanisms by which8the review schedule can be accelerated, expedited,9done in the most productive fashion possible.10And we are committed to not only11understanding the process of the NRC and being12extremely responsive to that process, but also doing13everything we can possibly do to make that review as14expeditious as possible. And we hope to have that15kind of conversation today to understand how we might16work better together to get the review done and as17quickly as possible, without compromising our combined18committee to public safety, as well as public health.19And so I did have the opportunity on the20nine hour trip yesterday, in the care of one of our21major airlines, to review the materials that Mike had22provided to Carolyn in advance.23And in the interest of everybody's time24assembled, I think the package is great from an25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 18educational standpoint. I think we understand largely1the background.2And so perhaps going through the general3information as quickly as possible, and getting4specifically more to those two follow up items, could5save us all some time. Because we have reviewed all6the guidance from the NRC. We've reviewed the general7information.8And so getting quickly to the areas of9combined interest is certainly our objective here. 10So, Michael, thank you very much for providing the11materials early.12And with that, I'd like to turn it back to13the NRC to begin this, what we all hope, to be a very14productive meeting.15MR. BALAZIK: Thank you, Nicholas, I16appreciate that.17MS. GAVRILAS: So just one comment. The18slides that you have, we really appreciated the fact19that you reviewed them before we're going to talk20about them.21They're intended to engage you in dialogue22with us. They're intended to basically, we're talking23in general, and you may want to take the opportunity24to ask, how does this impact us.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 19What we're trying to understand is, not1just what your questions are, but why you asked those2questions. Because we want to make sure that we're3answering, not just the words, but the intent of what4you're trying to find out.5So again, thank you for going through6them, this is great. It seldomly happens. And we'll7just use them as context for the rest of the8discussion. So please, at any time, just stop us and9talk to us about everything. Thanks.10MR. BALAZIK: All right, this is Mike11Balazik again. First of all, for transcription12purposes, please identify yourself prior to speaking. 13And let's start the presentation.14One item that I'd like to add is that no15proprietary materials planned to be discussed by this16staff during this meeting. However, if Northwest17Medical Isotopes believes that we are starting to move18in that direction, please let us know so that we can19cut off the discussion right there. So thank you.20All right, these -- here's the staff21that's presenting today. Earlier we've all identified22ourselves so we'll go through these slides real quick.23Basically this is the meeting purpose. 24Here's some of the main topics we want to cover today. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 20Just provide a general overview of the NRC, oops, I'm1sorry. It skipped one on me.2Provide an overview of NRC licensing3processes, provide an overview of NRC regulations and4guidance for construction permit operating license and5a Part 70 license, as well as a 30 license. Discuss6review timeline. Provide status of the construction7permit application review and discuss communications. 8Okay?9And next we'll go into the licensing.10MR. LYNCH: Sure. This is Steve Lynch. 11And just to give myself a little bit more of an12introduction.13For those who don't know, I was involved14with the SHINE review and was the lead projector15manager for that. So I'm helping out with the16Northwest review to provide insights and input to help17gain efficiencies and lessons learned from previous18reviews that we've done. And apply them.19And that's what we try doing at the NRC. 20Is we've done something before, hopefully the next21time we do it we can apply the lessons learned from22before.23So to get started with this introduction24here, these considerations are for both the applicant25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 21and the NRC. We want to emphasis that where we pick1the licensing process from the regulations is driven2by the technology that's put in front of us.3And especially with the medical isotope4facilities. Some of the considerations that we look5at are, how much material are you going to have, what6types of material will be onsite.7That will help determine where you fall in8the regulations, the activities that you're actually9going to be performing with this material.10Are you going to be making targets, are11you going to be irradiating targets, will you be12processing targets. How will you be irradiating your13targets. Will you be using a nuclear reactor. Will14an accelerator be involved.15Then we also look at the, how you're going16to be processing the targets afterwards. And the17bigger driver for licensing regimes there is, looking18at the batch size.19As I'm sure you're very well aware, if20you're processing batches of greater than 100 grams of21special nuclear material, that will put that activity22into the Part 50 licensing process.23And then one of the other considerations24we look at is, will you be using new or existing25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 22facilities. And as I understand with Northwest, it1will be a mixture of both. Using existing research2reactors as well as constructing a new facility for3processing.4Next slide. So once we've looked at all5the technology and how you're going to be using the6material, the next step is to try putting it into the7different boxes we have in our regulations.8These are not all of the regulations that9you need to follow in order to get a license. But10these, in terms of the application that you provided,11are some of the main technological boxes that we'll be12looking at in terms of licensing the production13facility in Part 50.14The special nuclear material will be15looked at under Part 70. The moly that's produced16we'll be looking at under Part 30.17And then with all of this, we'll be18looking at the environmental impacts of these actions19and how the material will be used.20Next slide. So we're going to spend today21highlighting some of the different processes that we22use from that previous slide. Especially focusing on23Part 50, for the production facility, Part 70, for24material. And then also Part 51 for the environmental25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 23review process.1And we just kind of want to step through2these processes to see if you have any questions about3how we are conducting the review of the application4that you've provided us.5So we'll get started with an introduction6to how we're looking to have a Part 50. In order to7go through the Part 50 and licensing process, there8are two licenses that you will need to apply for and9get from the NRC in order to operate your facility.10And that's a construction permit, which11you have applied for, and an operating license that we12will look forward to reviewing, if you choose to13submit one.14The main components of the construction15permit are the environmental report and the16preliminary safety analysis report. You've submitted17both of those, so you're familiar with their content.18And then for the operating license19application, we'll be looking at your final safety20analysis report, which includes more information, and21was in your PSAR. Including your plans for operation,22handling emergencies and your technical23specifications.24Another main component of the operating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 24license application will be the Physical Security1Plan.2Our commitment to doing these reviews, for3both the construction permit and the operating4license, is to finish these reviews within a year and5a half to two years from docketing the application.6Based on the experience that we have7recently with applications like this, we believe that8we can meet that review schedule.9Yes, we're going to go into more detail10about ways that we can, that factors that may11accelerate or hinder our ability to meet this.12Next slide. So today we'll focus mostly13on the regulations and licensing surrounding14construction permits. Since that's the application15that we have in-house.16If you would like to gain better17understanding of the operating license review process,18we can certainly discuss that in a future meeting.19For here, I wanted to highlight some of20the more important regulations concerning the21construction permit. This is highlighting the main,22you know, 50.22 puts you into the realm of the23commercial facility under the Atomic Energy Act. 24That's Section 103.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 25And as I'm sure you're aware, this is1slightly different than most of the other non-power2facilities that we license under Part 50. Those are3generally research reactors that are non-commercial4facilities.5And the main difference that we see there6is that there will be a mandatory hearing on your7application. And there will be a review by the ACRS8as well.9The other, some of the other things that10you're aware of under 50.30, you're to submit an11environmental report, which you have done. And submit12a preliminary safety analysis report under 50.34, also13what you have done.14And then some of the other important15regulations that you address in your accident analysis16are meeting both occupational and public dose17requirements under Part 20.18All right, then after we finished our19review of your application, what the NRC is fighting20to come to a conclusion is, can you construct your21facility as described in your PSAR?22And what we're looking at there are these23regulations that I have listed at the end there. 2450.35, which I'll go into more detail on on the next25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 26slide, as far as the findings that the commission1needs to make in order to issue a construction permit. 2And those are supported also by the findings that are3in 50.40, 50.42 and 50.50.4Next slide. So as the NRC evaluates your5application, these are the primary four findings that6we are looking to make, based on the information that7you have provided.8We'll look at, to see, have you provided9the proposed facility design. And the emphasis here10is, what we're looking at for is, have you given us11your principle design criteria in this first bullet.12As you're aware, 50.34(a) does require13that you describe your principle design criteria. 14Unlike nuclear power reactors, the principle design15criteria are not enumerated in Appendix A of Part 50. 16And that you are left to propose your own design17criteria per your facility in this case.18We also recognize that we are being19provided a preliminary design. And as such, there may20be information that you have not provided at this21time.22We're looking to make the conclusion that23the information you have chosen to provide at a later24date is acceptable, but we don't need it at this time25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 27in order to establish a preliminary design.1Something else, 50.34(a)(8) allows ongoing2research and development through construction. For3those areas that you've identified that you have4ongoing research and development, we'll be looking to5see that you have a research and development program6developed and setup in order to resolve any safety7questions associated with those items.8And then all this comes down to, that we9need reasonable assurance, that prior to the10completion of construction, any safety questions that11are opened, will be resolved in the interest of public12health and safety.13Next slide. So this slide, what I wanted14to emphasize is the difference between the15determinations that we're making at the construction16stage and at the operating license stage.17At the construction stage, we're18essentially only -- we're allowing you to go forward19and construct. You've given us enough information for20us to say, go ahead and get started.21In contrast, when we issue an operating22license, this is when we say that, based on the final23design of the facility, that we believe it can be24operated safety. So I just wanted to emphasize the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 28difference in the emphasis that we place in those two1determinations.2Next slide. So I'm hoping this slide3helps partially answer one of your questions that you4had about the licensing process and how we look at5your applications and how you can submit them. And6we'll go into some more detail on this when we get7specific with your application.8But both the Atomic Energy Act and the9regulations allow for an applicant to combine10applications. And this is common.11There's, and mostly we'll see this with12the operating license application. In order for13reactors to operate, they will also require a Part 7014license in order to possess and use material on their15site.16And then following that up, the commission17does combine those licenses. So you see, and Al will18show you an example of that later today.19When reactors are issued licenses, there20is typically a Part 70 license. And the Part 3021license, and sometimes the Part 40 license that are22combined together in that, is on a single piece of23paper and a single license.24So we are --25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 29MR. FOWLER: Can I ask a question at this1point?2MR. LYNCH: Yes.3MR. FOWLER: At the executive director4meeting, Mirela, I believe you did a, at least you5helped me, and I'll use the, I could use inappropriate6terms in the regulatory environment because it's not7an environment that I deal with every day, but I8understood from your presentation, in that meeting,9that we had the choice. That we could submit a10separate Part 70 license or we could submit, under the11Part 50 umbrella, the Part 70 requirements with the12important caveat that the Part 70 information, at that13point of submission, needed to be final because it was14a one-step process.15And so I understood our follow up to be16within one week of that meeting, to confirm that17understanding to us that we had that option, between18those two choices. And, so I think in the interest of19time, if we could simply confirm that, that our20understanding is compatible with your understanding,21I think we're all set.22MS. GAVRILAS: What I said at the meeting23is still what our position is. And we'll walk you24through the slides.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 30This just helps explain the details. The1bottom line is, we look at your activities from a2safety perspective. And the security perspective.3So as long as we -- and our rules and our4guidance help us know what we need to evaluate in5those activities.6So whether the description of how you make7your safety case comes on one piece of paper or on two8pieces of paper, is not that important. In the end9we're going give you one license that captures all of10those activities.11But the review is going to be, we're going12to look at every safety component that we need to and13every security component of all the activities that14you are proposing.15So in other words, it doesn't matter how16the information comes in, the regulation is designed17to allow us to combine that information into one18license. And the regulation does allow us to19basically eliminate repetition.20So if you provided something in one21context, you don't need to resubmit that information,22because you do get credit for it under the activity. 23If the activity was described on one piece of paper,24you get credit for it. You don't need to describe it25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 31again.1MS. HELTON: Mirela, I agree. I just want2to make sure that it's clear that the packaging is up3to you. How you package it all together, multi4submissions, a single submission.5What needs to be clear, in your submission6or submittals, however you decide to do it is, what7regulations you're seeking to comply with. And then8you also have to fully demonstrate your compliance9with those regulations.10So it just has, however you do your11packaging, it has to be very clear that if you intend12for this information to satisfy Part 70, subpart (h),13or whatever you're going to do, that you have to very14explicitly.15That will help our review greatly if you16very explicitly say, this is the information that17complies part umptysquat. But, you know, we can't18identify that for you, you have to identify what parts19of the regulation you need to comply with, and then20you have to demonstrate how you comply.21MS. GAVRILAS: And to add to what Shana is22saying, you can cross reference in all of your23document that you submitted.24MS. HELTON: Right.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 32MS. GAVRILAS: And right away, that adds1to the case that I'm trying to make in this piece of2paper.3MR. FOWLER: So very simplistically, from4my standpoint, again, because I'm not schooled in the5art of regulatory review, is the final Part 706information, we can include, either in our operating7license under Part 50 application or as a separate8Part 70 document, but we need to be clear about what9we're submitting under which format.10MS. HELTON: Right.11MR. FOWLER: So if I have that very high12level kind of understanding, that will put it in my13brain, Carolyn will take care of the details. But at14least now I have it in my brain that the Part 70 is15either under an operating license or under a separate16Part 70 submission.17MR. LYNCH: Yes. And I think what's most18important there is, we're looking to make our safety19determination based on technical information that you20provide.21Whether it's Part 50 or Part 70, we still22have to say, we have technical requirements that we're23trying to make to justify safety. So we're looking24for technical information.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 33And when we have all that technical1information, we can figure out which box, you know,2will it be a full, will it be Part 50 with Part 70 as3part of that or separately. But we will evaluate that4based on the request that you ask of us.5MS. HAAS: We understand the safety6aspect. I mean Nick is just trying to bring it up --7MR. FOWLER: Yes.8MS. HAAS: -- because it's based on9conversations we've had over the last two or three10years and it got modified within your organization. 11So we just wanted to make sure that we understood it,12and we do. So thank you for the input and we'll move13on.14MS. GAVRILAS: You know, we start every15public meeting with a disclaimer, which is, we're not16going to reach regulatory decisions here and there's17a reason for that.18Everything that the staff reviews needs to19be on the docket. I mean that's the tentative of how20we operate.21So we have dialogue here. So right now,22what we have for review in front of us and what we can23be very specific on, at least the portions that we've24reviewed, is the construction permit. The Part 5025NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 34construction permit.1Anything else is in pre-application space. 2If that makes sense?3So if there is -- if we're sometimes4tentative or give you our best opinion, we will5clarify. That opinion will become definitive, once we6have an application in front of us.7It's worth repeating because, again, in8the absence of information, all we can do is say what9the most likely path is.10MR. LYNCH: Okay. Next slide. So what11we're going to transition to now is talking a little12bit more about the actual review process for the13construction permit. And we'll get into timelines and14what our expectations are for the review that we have15ahead of us.16So to introduce this, this is just kind of17a high level flow chart to highlight the main pieces18of the construction permit review. We have two19parallel reviews that we'll be going on.20And this is our safety review of your21preliminary safety analysis report and the22environmental review of your environmental report.23The results of each of these reviews will24feed into a number of things that will lead ultimately25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 35to the commission's decision to either grant or deny1your request for a permit.2The review, the output of that will be the3safety evaluation report prepared by the staff. That4will be reviewed by the ACRS.5And as part of their independent review,6it will also be considered by the commission and the7mandatory hearing.8There's also a possibility that there9could be contentions filed as a result of this. And10we'll talk a little bit more about that in a few11slides, but that's another step that could be in this12process.13The environmental review will also be, the14environmental impact statement that's being prepared,15will also be considered by the commission and its16decision to grant or deny the construction permit.17So right now I'm going to turn the18presentation over the Nancy Martinez, the project19manager leading the review of your environmental20report. And she's going to talk through some of the21specifics of the environmental review process and the22status of their review.23MS. MARTINEZ: Thank you, Steve. As Steve24mentioned, I'm the environmental project manager for25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 36the application. And I'm going to discuss the1environmental review process.2The environmental review is going to be3performed in accordance with the National4Environmental Policy Act of 1969. Commonly known as5NEPA.6NEPA requires fellow agencies to follow a7systematic approach in evaluating the potential8environmental impacts of the proposed action and to9assess the alternatives to those actions. The NEPA10process involves public participation and disclosure.11NRC's environmental regulations12implementing NEPA are contained in 10 CFR Part 51.13Slide 17 please. This slide presents an14overview on the steps that lead to the environmental15review process.16When an application is submitted to the17NRC, the NRC conducts an acceptance review. And an18acceptance review determines if the application has19sufficient information for the staff to conduct its20technical review.21If the application is accepted, the NRC22staff conducts a NEPA document determination. And23that is to whether develop and prepare an24environmental assessment or an environmental impact25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 37statement.1I will discuss in later slides, for the2Northwest application, the staff determined to prepare3an environmental impact statement. Once the NEPA4determination is made, the environmental review5process is conducted in accordance with 10 CFR Part651.7Slide 18 please. This slide presents an8overview for NRC's environmental process. 9Specifically for the environmental impact statement.10The environment review for an EIS begins11with the scoping process. Which includes a public12meeting.13Scoping is a process by which the NRC14staff identifies a specific impact and significant15issues to be considered in preparation of the16environmental impact statement.17Following the scoping process, the NRC18staff will perform its environmental analysis, which19will consist in part, of issuing request for20additional information to the applicant and preparing21the draft EIS.22The draft EIS is issued for public23comment. Once comments are received on the draft, the24NRC staff will consider those comments and issue its25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 38final environmental impact statement.1Slide 19 please. The environmental review2for the environmental impact statement will take 18 to322 months. This slide provides a detailed breakdown4of the process and timeframes.5As I previously mentioned, the6environmental review will begin with the scoping7process. Which for Northwest consisted of a 45 day8scoping period and a public meeting.9After the scoping period ends, the staff10develops a scoping summary report that addresses11public comments that were received during the scoping12period. This takes a minimum of 90 days and depends13on the number of comments that were received during14the scoping period.15The environmental analysis, in part, will16consist of developing and issuing a request for17additional information. Each round of RAIs will take18approximately 90 days.19And this will consist of developing and20issuing the RAIs, a 30 day response period and then21the staff reviewing the responses for clarity and22adequacy. The number of RAI rounds will depend on the23quality of RAI responses and the application.24Information from the applicant's report,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 39RAI responses, the scoping process, coordination with1other federal, state, tribal and local agencies, as2well as the staff's independent research, will be used3to draft the EIS.4When the draft EIS is published, it will5be made publically available for review and comment6for a 45 day period, in accordance with our7regulations. The comment period will include a public8meeting.9After the draft EIS comment period, the10staff will respond to comments provided on the draft11EIS and update the EIS as necessary. And this can12take approximately 120 to 150 days. And depends on13the number of comments and also the necessary EIS14updates. The final EIS is then issued.15Slide 20 please. The staff will perform16its environmental review in accordance with 10 CFR17Part 51. And will also use Interim Staff Guidance18augmenting NUREG-1537.19Slide 21 please. On February 5th, 2015,20Northwest resubmitted Part 1 of its construction21permit application. The public notice of receipt and22availability was issued on April 21st, 2015.23The NRC staff conducted an acceptance24review of the Northwest environment report, Chapter 1925NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 40of the application, in accordance with 10 CFR Part 51,1which identifies the information that shall be2contained in the applicant's environmental report.3An acceptance review is a completance4review that determines if the application has5sufficient information for the NRC staff to begin its6technical review.7Part 1 of the Northwest application was8accepted and the notice of acceptance was issued on9June 8th, 2015.10Slide 22. In accordance with 10 CFR1151.25, the staff determined whether to prepare an12environmental assessment or an environmental impact13statement.14Pursuant to 10 CFR 51.20(a)(2), the staff15determined that an EIS should be developed for the16proposed action. This determination was based on17operation of the proposed Northwest facility.18Connected action to the issuance of a19construction permit, consisting of target fabrication20and scrap recovery. A process similar to the process21used by field fabrication facilities, for which an EIS22is required under 10 CFR 51.20(b)(7).23Slide 23 please. The environmental review24will consider the impacts of construction, operation25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 41and decommissioning of the Northwest facility. We1will also consider the impacts of alternatives to the2proposed action, including alternative sites,3alternative technologies and the impacts of not4issuing a construction permit.5The environmental impact statement will6also consider the impacts from irradiation services7provided by the research and test reactors. Which is8a connected action to the proposed action.9Ultimately, the purpose of the10environmental review is to take a detailed hard look11at the environmental impacts of the proposed Northwest12facility. And after balancing the benefits versus the13cost or impacts of the proposed project, make a14recommendation to the commission on whether or not to15issue a construction permit.16Slide 24. The Northwest environmental17scoping period ended January 4th, 2016. The staff is18currently developing the scoping summary report and19responding to comments.20Two rounds of RAIs have been issued. The21first on November 2nd. Northwest responded to those22RAIs on December 3rd. The staff reviewed the23responses and had some follow ups. And those RAIs24were issued on January 19.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 42NRC anticipates that the draft EIS will be1issued on October 2016 and that the final EIS will be2issued on May 2017. And this is based on the3timeframes in the slide that I have provided earlier. 4And is keep within the 18 to 22 month schedule.5And that concludes my presentation on6environmental review.7MR. LYNCH: All right, next slide please. 8For those on the phone, this is Steve Lynch again. 9And I'm going to talk a little bit about the10construction permit safety review process.11Briefly touching on the content of the12PSAR in a little bit more detail, as well as going13through some of the assumptions that we made and14coming up with this 18 to 24 month timeline for our15review schedule.16So as I mentioned, I've mentioned most of17this before. The main components of the preliminary18safety analysis safety report are the preliminary19design of the facility. A preliminary analysis of20structure systems and components with an eye towards21how those will be used to prevent and mitigate22accidents.23While you're not required to submit24technical specifications at this time, we are looking25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 43for the application to identify probable subjects of1technical specifications.2And again, while emergency plan also is3not required, there are some requirements in Appendix4E of Part 50, to address a preliminary emergency plan.5We'll also be looking at your quality6assurance program and any planned research and7development that you have.8Next slide please. So for the review that9we do, so the last slide talked about the regulatory10requirements that need to be met. We had developed11guidance in order to evaluate whether those12requirements have been met.13And for your application, the guidance14that we are primarily using is NUREG-1537, as15augmented by Interim Staff Guidance.16And the most applicable part of that, as17you used in the development of your application, was18the guidance for radio isotope production facilities. 19And that was largely based on guidance in NUREG-152020that Dave will talk about in a little bit.21Other guidance that we used. There are22ANSI standards that are referenced in these documents23we used for our reviews as well.24Next slide please. So getting more into25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 44the process and timeline. After you submit your1application, first thing the NRC staff does is review2the application to see if we have enough information3to accept it for docketing.4What goes into this acceptance review is,5we look at the request you made for the type of6application you are seeking. We see if we have the7technical information, the application to support that8request to conduct our review.9And if we're aligned on the request you're10making and we think we can review it under that11licensing process, then we make sure that we have all12of the information required by the regulations for13that process.14We're not doing a detailed review at this15time, we're looking for completeness of the16application. And if we believe that the application17is complete and has addressed all of the regulatory18requirements necessary for that type of application,19we will accept the application and docket it.20And once docketed, that indicates the21beginning of our formal technical review of your22application.23And following that, our technical review24ultimately will result in the publication of a safety25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 45evaluation report. Which documents the NRC's findings1on the application and our recommendation to the2commission on whether we believe the construction3should be, permit should be granted or not.4In support of development of this safety5evaluation report, the staff may find it necessary to6request additional information to help us understand7the information that's in the application or to8provide any additional details we need to make our9conclusions.10After we complete our safety evaluation11report, we will present this report and you will12present your PSAR to the ACRS. There will be13subcommittee and full committee meetings on this.14And the ACRS will provide an independent15review of your application and the NRC staffs16evaluation and provide a recommendation to the17commission on whether they believe the construction18permit should be issued.19Following this, we do have the potential20for a contested hearing. And there will be a21mandatory hearing. Where, again, the adequacy of the22safety and environmental reviews will be considered. 23And that will ultimately lead to the decision to grant24or deny the construction permit.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 46Next slide please. So I put together a1sample 22 month safety review timeline that's based on2our previous reviews. And also just kind of a middle3ground between that 18 to 24 month time period.4And I wanted to highlight just some of5what went into that so it doesn't, it isn't a complete6mystery of what we're doing while we're reviewing your7application.8So after docketing your application,9within about two months we are, our goal is to begin10issuing requests for additional information, if11necessary.12Our goal is to complete issuing our first13round of request for additional information within14about a six month time period. So that will take us15to, as you see on the screen there, in eight months16after the docketing of the application, our goal is to17issue all of the requests for additional information18that we may have on your application.19Typically, when we issue a request for20additional information, we will ask for a 30 day21response timeframe. If this is not something you22believe you can meet, you can talk to your project23manager and workout a time period that will work for24both of you.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 47So after about nine months, our goal would1be to have received responses from you on all of the2requests that we have issued. Following that,3reviewing the information and providing request for4additional information, it may be necessary to ask5additional RAIs.6So in this timeline we've incorporated the7need for a potential second round of requests for8additional information. That would require another9six months' time period.10After all of our requests for additional11information have been answered, and the staff is able12to complete a safety evaluation report, then we go the13ACRS. And right now, in this timeline, we have about1419 months after accepting the application for15docketing, we would hold our first ACRS subcommittee16meeting.17Based on our past experiences, with18licensing similar applications, we have seen that it19will be likely necessary to have multiple ACRS20subcommittee meetings.21In this timeline we have anticipated there22could be two ACRS subcommittee meetings. And these23can be held, essentially you would have an24opportunity, at most, once a month, while the ACRS is25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 48in session, to meet with them to discuss that.1Once the ACRS is satisfied, at the2subcommittee level, that you have addressed all of3their technical concerns with the application, a full4committee meeting can be scheduled. And after the5full committee meeting, the ACRS would prepare its6recommendation to the commission on your application.7Following the completion of the ACRS full8committee, the staff has been able to finalize its9safety evaluation report based on feedback provided by10the ACRS. And after that is when we would schedule11the hearing.12Next slide please.13MR. ADAMS: Can I, this is Al Adams, can14I -- I just want to emphasize one point on this slide. 15Although this slide shows 22 months, that you can see16the licensing activities are completed on this slide17in the first 18 months.18So there is time that is devoted to19activities, which are beyond the development of the20safety analysis. The visits to the ACRS and the21mandatary hearing.22So although it may seem like a 22 month23schedule, the actual licensing work is condensed into24the first 18 months of that. Thanks.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 49MR. FOWLER: And what I -- pardon the1interject here, but I see, you know, the objective2that I have in this meeting are to explore, how do we3accelerate schedules.4MR. LYNCH: Yes.5MR. FOWLER: And I appreciate this6outline. There is implicit assumptions about cycles7in here.8And that's an obvious opportunity to9reduce the overall time, if we reduce the number of10cycles.11MR. LYNCH: Yes.12MR. FOWLER: What is less clear to me is,13what drives subsequent cycles? Is there a threshold?14What's the bar that we, as a company, need15to meet to avoid a subsequent cycle and therefore16accelerate the schedule? That's what's not so clear17to me.18MR. LYNCH: So I think that there's a19number of things that we can do. And when we ask,20what we can do is, when we ask, request for additional21information, it's important that you understand the22questions that we're asking.23You can go to the next slide. Let me24answer your question and then we'll go through the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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. But1it's all related. That's the next topic I was getting2to.3But when we issued the request for4additional information, it's important that after5they're sent to you, you have them, read through them,6have a phone call with us. If we need to meet, we can7do that as well.8But we want to make sure that for every9question we ask, you clearly understand what we're10asking. And if you don't understand, you ask us to11clarify.12Because it cannot be the best use of13either of our times if you don't understand the14question we're asking. You answer what you think15we're asking, but that's not what we're looking for,16then we have to ask the question again.17So making sure that we have a clear,18mutual understanding of what the information gap is19that needs to be filled, that can help.20And then as you're preparing your21responses, check in with us again and make sure that22you still understand and you're going down the right23path. And providing complete answers the first time24they're asked can also help.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 51So I think one of the keys two reducing1the iterations that we have to go through in that RAI2process, is making sure that you understand the3question that's being asked and providing complete4responses to that.5MR. FOWLER: So we're learning how to work6with each other?7MR. LYNCH: Yes.8MR. FOWLER: And we've had some9experience. And, Nancy, maybe I can put you on the10spot here because we've now had two cycles of requests11for additional information with the environmental12portion of the technical review.13How would you characterize the ability for14the two organizations to communicate?15Is the second cycle driven by a16communications challenge or is it driven by, you peel17the layers of the onion back and you find something18that you didn't see the first time that initiated a19second round of questions?20So in order to be productive, help us to21understand, from the limited experience we have22already, how we could do it even better on the next23cycle.24MS. MARTINEZ: So for the environmental25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 52review RAIs, the second round of those RAIs were1driven by follow ups to the first round where the2question was not addressed adequately. So we had some3follow ups on that.4But we also had some follow ups on the5responses because information was provided, and then6we needed additional information just based on the7response. It was really a combination of some of the8questions were not answered completely, and then there9was responses provided, and then we had follow up to10that.11We also did, you know, when we issued the12RAIs, as Steve mentioned, we did say, let us know if13these are clear and if you would like to have a call14to discuss them. We did that for both rounds.15So we're hoping that that will open that16communication channel, as you just said.17MS. GAVRILAS: I want to take it a step18higher, because this is general. So you mentioned the19two cases. Indeed, those are the two instances for20which we ask additional RAIs.21There's an expectation that the technical22reviewers have started to write their safety23evaluations and are well along their safety24evaluations.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 53So when they ask, when they request1additional information, it's designed specifically to2augment the piece that they're writing right now. So3that means it truly -- they know exactly what they4want. Or they have a very clear picture of what they5want.6I'm not saying that the peel the orange,7you know, or onion, whatever you're peeling, doesn't8happen, but that's rare. Because of how we do, how9the expectation is that when you ask an RAI, you10basically know what kind of information you're seeking11to document your safety conclusion.12So along the lines of dialogue, there's13two times that there's opportunity for dialogue when14it comes to a request for additional information.15One is, when we are drafting the question16itself. Right? Because then we want to make sure17that we engage with you and make sure that the words18that we put on paper, do convey our needs.19And then there's a second opportunity to20engage in dialogue. Which is, when you've drafted21your answer, we have an opportunity to check that22indeed your answer answers the mail.23That is, in our experience, the most24efficient and effective way to deal with responses for25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 54additional information.1MR. LYNCH: Nicholas?2MR. TIKTINSKY: And I'd like to add a3little more on that too. A lot of it's nature of the4rounds of questions. And this is Dave Tiktinsky.5A lot of it is nature of the rounds of6questions. So if the questions are, you provided 907percent of the information we want and we need some8clarifications of something, then usually it only9requires one round.10If the questions are more like, you need11to develop or give us your methodology that you, how12you develop something or you're programing, we need to13understand what that is. Once we get that answer,14about what your program is or what your methodology15is, that may lead us to other questions.16So really it's the nature of how the17information was in the application, how specific it18was. And really the level of what that question is.19The specific questions, usually can handle20them in one round. The more programmatic, methodology21kind of questions frequently require follow ups.22MR. ADAMS: And, this is Al Adams, I just23want to build on something Mirela said. That that24discussion that we have, once you start to develop25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 55your answers, that's not a sort of a verbal review of1your answer.2I mean, you know, the reviewers have to3sit down and carefully consider the answers. What4that is looking for, if we're expecting an answer to5go in this direction, and when you talk to us, we find6out that you're going in a completely different7direction.8So it's basically to find significant9issues before you submit the answers to us. So if you10submit the answers to us without having that11discussion with us then, you know, then there's just12possibility for a misunderstanding or13miscommunications in the RAI process. And that can14contribute to additional questions.15MS. GAVRILAS: And we cannot, this is16Mirela again, we cannot emphasize enough how important17that dialogue is. Those are the, probably the biggest18contributors to our expediting the review.19MR. LYNCH: Okay. Actually, so I think20we've talked mostly through Slide 30. Let's go to21Slide 31, which will continue this conversation we22have on impacts to schedule.23And this, in addition to RAIs, there is24other things that we can do to help ensure that our25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 56review is moving along efficiently. And can impact1schedule.2One is the quality of the application3where all the regulatory requirements met. And this4is, I'm speaking hypothetically and not in your5application.6But if we do a review of the application7and the regulatory requirement is not met, it could8result in the application being rejected and needing9to be resubmitted. Or it could result in significant10new information that does need to be presented and for11review.12Technical and completeness. Again, the13more information you give us without having to ask for14it, the more efficiently we can review the15application.16And then also just attention to detail. 17And this has to do with the organization of the18application, formatting, looking at proprietary19markings. Just those little details that maybe aren't20necessarily technical, but can help us in our review. 21If we don't have to worry about the little things.22Then building on our conversation on23request for additional information, in addition to the24number of rounds we ask, the quicker that you provide25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 57responses to us, the quicker we can continue on with1our review.2So timeliness, responsiveness,3completeness of our requests and how you provide4answers to them, that can all help facilitate our5review.6And I think a good point that Dave7mentioned was, what can take more time is if in these8requests for additional information, significant new9information is provided that we have not reviewed10before. That can take additional time. And could11result in additional requests.12MR. ADAMS: Can I -- Al Adams. Can I jump13in here?14And completeness is probably the most15important of those things. If you, you know, we asked16for a 30 day response and you come in in 20 days and17look, you know, you've come in ten days sooner. But18those answers aren't complete and result in another19round of RAIs, that round is going to consume a lot20more than the ten days that you saved by coming in21early.22So completeness is the most important, I23think, aspect of this. And I think what you're seeing24is, you know, the thing that draws out schedules is25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 58having to go additional rounds of RAIs.1That's the most, you know, our experience2has shown us that's the most significant contributor3to schedules being drawn out.4MR. TIKTINSKY: Another thing I might want5to add too is, we're not going to wait till the end to6give you all the RAIs at one time. You saw that, the7schedule that Steve had shown there.8The idea is, when major portions of the9review are done, we will ask RAIs that are10appropriate. We don't want to be asking you the same11technical area a bunch of different times.12So when we're done with an area and we13feel like we're done with that part of the review and14comfortable with that, we'll ask those rounds of15questions. But we want to spread it out over that16time period, the six month time period that Steve had17outlined.18It's more efficient that way and it allows19your staff to work on it. Also, we don't want to hold20somebody up, you know, waiting for another disciplines21review to be done.22MR. ADAMS: So you may get a second letter23from us, but it's actually the first round of RAIs in24that area. And there's nothing to be gained by25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 59sitting on the RAIs and giving you a hundred questions1at once and overwhelming your ability to answer.2So when we have an area ready to go, we3will 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'd6just like to reemphasize that when, especially when7you're crossing different portions of the regulations,8that the clearer you are in your initial submittal9about, this is how we're meeting 70.32, this is how10we're meeting 50.20.11I mean just the clearer you are in your12application, will help us avoid those types of request13for additional information where we say, hey, tell us14how you're meeting the requirements in here.15And then if we're at that sort of basic16level of, how are you meeting the regulations when you17give us that answer, that's almost guaranteed a second18round because now we're going to ask you questions19about that.20I mean every applicant wants to avoid21going multiple rounds of request for additional22information. But it's just been our experience that23when we have to do those basic sort of questions24about, how are you meeting our regulations, that tends25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 60to, once we see the detailed technical information, we1tend to then have questions about that.2So I can't emphasize enough that initial3clarity in your submittal.4MS. GAVRILAS: So if I -- I'm sorry.5MR. MORRISSEY: No, that's okay.6MS. GAVRILAS: More comments on RAIs. 7Because I want to --8MR. MORRISSEY: No, I had just a9discussion about the technical reviews. My name,10Kevin Morrissey.11As having been a technical reviewer for a12long time, and actually I was a licensee, is my advice13would be, don't be shy about asking the staff what14they want.15You know, we're talking about all the16things we expect from you, you should expect to think17the same things and clarity from the staff. You know,18lots of time we go, I shouldn't ask this, I shouldn't19ask that. Is you really have to dig down sometimes20and let your staff talk to our staff and really get21down to exactly where you're going.22Then you're less likely to end up in the23wrong place and wasting your time. So don't be shy. 24That would be my advice.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 61MS. HELTON: Absolutely. Getting the1technical experts to communicate directly so there's2an understanding, is a good practice. To have a3public meeting on those RAIs.4MS. GAVRILAS: So again, it's important to5sum up. It's important to distinguish between various6increments at the same round, the RAIs and follow up7RAIs.8The increments are designed to help us9all. To move the process along.10The follow up required are basically11because we needed additional information. And while12we can't, those are the ones that we target for, for13minimizing. We can't eliminate them completely, but14we target for minimal follow up RAIs.15I want to go back on Slide 30, Steve, if16you can, for just one moment. Because there's --17we've talked a lot about RAIs and how you can do, what18you can do to basically help us out, speed the process19along.20But what's important in our timeline is21also to recognize that there's a safety reason for how22the timeline is developed. There's nothing that's23carved in stone, because it's arbitrary.24And I'll give you, as an example, the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 62writing of the SER. It doesn't help to distribute a1chapter in a technical area amongst reviewer. That2won't speed up the process. The review has to be3comprehensive. The reviewer needs to see everything.4If there are chapters that cross over5technical expertise, that needs to be seen by6everybody. So the timelines that you see that it7takes the staff to draft the SER and to come up with8RAIs, is also informed by basically what we need to do9to come up with a safety finding.10And with that, I'll turn it back to where11it was.12MR. LYNCH: Sure. Back to Slide 31. 13Again, this is Steve Lynch. Other impacts that, to14schedule, could be if there are policy questions that15need to be resolved. I can give an example from a16past, a past review.17In the case with SHINE, we had to go to18the commission to resolve how, you know, whether SHINE19should be under Part 50 versus Part 70, and we ended20up needing to do a rulemaking in order to classify21them under Part 50. That can be a potential impact to22schedule if that's something that's necessary in our23review.24Also, the one thing that can drive25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 63schedule, is the number of times we have to go to the1ACRS. Limiting the number of subcommittee meetings2that we have to have, by addressing the technical3concerns with the ACRS, can significantly improve or4delay the schedule.5MR. ADAMS: Al Adams. I just want to, the6ACRS tells us when they've received enough information7before they can write the letter they need to write to8the commission.9So it's something that quality has control10over, but we don't run the ACRS and the committee. 11And they have to do the review and reach the12conclusions they need to reach given what they're13responsibilities are.14MR. LYNCH: Yes. And what we can do to15help them is, when they do identify areas that they16need additional information, that both the applicant17and the NRC staff provide that as quickly as possible.18All right, next slide please. So on the19previous slide I was mostly addressing the things that20both the applicant and the staff can do to impact21schedule.22This slide is focused on the things that23are outside of the staff and the applicants control,24to a certain extent. And this gets into the hearing25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 64process.1And this comes after the ACRS meeting has2been held, the staff has completed its environmental3impact statement and the staff has completed its4safety evaluation report.5There will be a mandatory hearing on this6application since it is a commercial facility. And as7I just mentioned, but there's a lot of things that8have to happen before this mandatory hearing can be9held.10In addition, there is a potential, and we11put this out in our notice of opportunity for hearing,12members of the public could file a contention on a13portion of the application or the activities that are14being conducted. Or proposed.15And if that happens, those separate16hearings would need to be held and those issues17resolved before the mandatary hearing could be held.18After any hearings that need to be held19are held, including the mandatary hearing, then we get20the Commission's decision to deny or issue the21construction permit. Based on what we've seen for the22combined operating license applications, that have23followed a similar process to this, we have seen the24commission decision come anywhere between two and five25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 65months following the mandatory hearing.1So after the hearing happens, there is2additional time. And that's not time that the staff3can control, that's on the commission's schedule when4they make that decision.5Next slide please.6MR. BALAZIK: Hey, this Mike Balazik. I'd7like to provide a quick status update on the NRC's8review of Northwest construction printout application.9This slide shows the proposed schedule for10the review. Steve and others mentioned some items11that can drive the schedule, either delay or expedite.12As you can see, that NRC is actually13reviewing the application. And I just want to assure14you that we've allocated the necessary resources and15have the technical expertise to review all aspects of16the application.17As you can see on this schedule, the staff18has targeted September of 2017 for completing the19safety evaluation report. And then there's a couple20of milestones that we can't really put a date next to21yet.22There's a couple of related activities,23not on this schedule, I'd like to mention. One is the24license amendment application by Oregon State25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 66University to irradiate three prototype targets. This1amendment was issued in January of 2016.2And other item I'd like to mention is, for3the research reactors that you've proposed to do the4irradiations for Northwest, each research reactor5would have to submit a license amendment to irradiate6the targets commercially.7And we've received notice from the8University of Missouri that we can expect the license9amendment in calendar year 2016. And Oregon State10University has also notified the NRC that they plan to11submit their license amendment in first quarter12calendar year 2017.13MR. LYNCH: Okay. While we're on this14slide, do you have any questions about our review15schedule?16I think, and this is mostly based on17previous reviews and the sample timeline that we18developed. Do you have any questions on where we're19going?20MR. FOWLER: Well, I have an observation. 21And I appreciate this information. And I was somewhat22familiar with reading it.23And again, I'm looking to explore how we24can work together, while maintaining arms' length. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 67Obviously you have an ombudsman role and a review role1that is independent and so forth.2But I view this as a very critical public3health need. And I know everyone recognizes that, but4our sponsors and investors are major healthcare5institutions servicing tens of millions of Americans. 6They see this as a real issue that we do work7together.8They are not for profit organizations. 9They have a service mission to the American public. 10And they extend that service mission through us. To11provide this.12And they're expectation is that we work13collaboratively and creatively to not compromise14health or safety, but figure out ways where we can15reduce the number of RAIs.16How can the NRC better set our17expectations of what will minimize those rounds of18RAIs?19How can we work together to ensure that20the ACRS review is done in a single pass, rather than21two or three passes?22What do we need to do together?23And if we drop the ball, it's on us. 24Absolutely it's on us, if we drop the ball.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 68But if we know what the threshold is that1we're trying to reach, we will work our darndest to2get there. And that's what we're looking for. Is,3how do reduce the number of RAIs?4How do we, as much as we can, ensure that5there aren't multiple rounds through the ACRS?6Because if we reduce those number of7rounds and if we reduce the assumed number of RAIs, we8get a critical isotope to public much more quickly9than is even on this schedule. Or we, by insurers,10that this schedule is met and doesn't slip.11And that's the exploration that I'm very12keen on hosting. Because I think we have an13understanding of the process. Now how do we work14within that process, to have the most expedited15schedule possible?16MR. LYNCH: Okay. So I think, just at a17high level -- so where we're at right now, we're in18this February 2016 timeframe. We're anticipating19getting out our first request for additional20information on the safety review side. And I believe21we're on target for that.22So this is all heading towards completing23our draft safety evaluation report. So I guessing24you're looking at drive, making that June 2017 time25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 69come up sooner.1I think the best chance we have of working2towards that goal together, would be once those3requests for additional information are issued, just4like we discussed earlier, let's get a call setup as5quickly as possible so that we can discuss and make6sure you understand what we're asking. And --7MR. FOWLER: So to that point, Steve.8MR. LYNCH: Yes.9MR. FOWLER: You have insight by the10technical reviewers when an RAI is going to be issued. 11So rather than wait until it's issued, for us to12request a public meeting to follow up and then have13the mandatary noticing period and so forth, why don't14we automatically schedule a public meeting within15certain number of days of the RAI insight issuance, so16they don't have to wait longer?17MR. LYNCH: There are different ways that18we can do this. Yes.19And there have -- and the NRC can, you20could set up a standing public meeting once a month or21once every two months. You know, something like that. 22That could definitely happen so it's noticed and it's23already setup. That can be done.24Now it also depends on the nature of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 70discussion you would like to have on the RAIs. The1public meetings are more necessary if we need to have2detailed technical discussions about the RAIs.3If you would like to have a call, just4strictly on, do you understand this, yes or no, could5you explain to me at a high level if I'm not6understanding what it is, that does not necessarily7need to be a public meeting. That could be a phone8call between you and your project manager.9Or you and with appropriate technical10staff. Those could be very quick calls. If it's just11for understanding.12So it kind of depends on what we need. So13that can buy some time too. If it doesn't need to be14a public meeting, that can be done much more quickly.15MS. HAASS: Well, and that's why there was16the request, when we were at the EDO, was to go get17that standing meeting done every week, very short and18sweet, to say, okay, do we understand this. And then19we move on.20And so I'm glad that that got instituted21or executed that we're now doing that. And that has22helped.23MS. HELTON: I think when you talk about24the frequency, the right frequency for the standing25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 71public meetings, and they haven't been established1yet, but we certainly can do that. And we've got2other examples working applicants where we've met on3a biweekly basis.4So in terms, I wanted to chat and, I'm5sorry, this Shana Helton, about this question on6threshold. And what's the regulatory threshold that7you have to meet, as the applicant, to operate this8facility.9So the regulations, we went over the10NUREGs as they've been supplemented by the Interim11Staff Guidance. That is what we have set as the12threshold, if you will.13And each applicant is going to meet those14regulations in unique ways. With that said, you know,15we operated in a public manner. Everything is on the16docket.17We've alluded to similar reviews in terms18of looking at reducing the number of RAIs. I think it19would be helpful for you to do some research in ADAMS20for what similar designs, the types of requests for21additional information that we have had, and the types22of responses that have satisfied those additional23requests for information. And that should really help24to identify the threshold.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 72I mean that said, each application is1different, we review it on its merits. We're going to2have to take into consideration the unique factors. 3But that can at least give you a sense of the way we4think when we're going through these regulatory5reviews.6MR. LYNCH: Absolutely. I think that's a7very good point. And even more detailed in that, if8you really want to see, if you open up the safety9evaluation reports we write, especially those -- you10can look, for a good example, we just finished our11safety evaluation report for the SHINE review. And12using the same guidance that you used.13The guidance sets the threshold of the, at14the end of that, the NRC is explicit and the15conclusions that we are trying to make in each section16and each chapter that's provided. And there are17bullet points there.18And once our reviewers are doing the19reviews, they're looking at the bullet point, you20know, for the acceptance criteria. Was this21information provided. And then there's another bullet22point, can we draw this following conclusion from that23information.24So when we're looking at your application,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 73we're trying to answer those questions. If we can't1answer a question affirmatively, that's one of the2times we'll go to you for a request for additional3information.4Also, as you'll realize for a construction5permit, you may not have all of the information that6you would submit at the operating license stage. What7can also help the reviews is an explanation of the8information that you don't have right now, because9your design isn't compete, explaining why it's not10ready right now, but also acknowledging that you11recognize it is something necessary for the final12design.13The more, again, it comes back to the14completeness. The more information that you can15provide us, addressing the information that we're16looking for in the guidance, the quicker we can get17through the review.18And also we are kind of, since we're using19our guidance, NUREG-1537 and the ISG, that's kind of20the format that we're looking for. You can submit21your application in whatever form that suits you.22However, if you can expedite the review,23it does make it easier if it's generally aligned with24the guidance that we're using to go through with. So25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 74that's some other insight.1MR. TIKTINSKY: If I could add some more2on the RAI meetings? You're right. We don't just3wait until they're all done and then make a phone call4to you. We know when they're coming, we know when the5reviews are done because we, as project managers, we6work internally with our reviewers to try and make7sure we're asking questions that are clear, that have8appropriate regulatory basis.9So we're working internally. So we know10pretty, some time in advance, before we're getting11ready to formally issue the rounds of RAIs. And we've12had a lot of experience doing that. And having13setting up meetings.14And just for your information, you know,15parts of the information, like within the ISA, there's16other categories, besides proprietary information. 17There's security related information.18So the public meetings that we have, we19try and talk as much as we can in publically available20information. But there may be some portions of the21meetings that are closed. Not only for proprietary,22but for security related information and other23discussions.24So what we try and, you know, we develop25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 75in RAI, we try as best as we can to make the RAIs1themselves publically available. So that information2is out there.3Your answers may or may not be publically4available, but like I said, we've had a lot of5experience in other reviews of making sure we have6those conversations.7I'd also like to emphasize the point too8is, depending upon the nature of the answers, we do9the same thing. Have the same kind of meetings when10you submit answers.11So before you formally submit something to12us, it may be a call or you may have a meeting too. 13If you have substantial discussions about something to14make sure that you're really are hitting the mark.15Again, we don't do reviews on the fly, but16you can get a pretty good sense that, yes, if you're17on the right track or not. And that would minimize18any problems.19But yes, we do plan things out. We try20and coordinate that carefully with the reviewers. And21we know where the status of things are.22And again, that's why I mentioned before,23we're not going to just consolidate a bunch of24different disciplines and do it at one time, we're25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 76going to try to phase this through, review it and try1to make it as efficient as we can.2MR. ADAMS: And this is Al. I'll just add3two things. One is, NUREG-1537 is a guidance4document, but it is an important document in that it's5a format content guide and the staff standard review6plan.7What we expect for RAIs is that the RAI8will start by saying, either here's a regulatory9requirement or here's something that the standard10review plan is looking for, here's where your11application, the information in your application seems12to say something different or doesn't seem to have13this information. And then the question will come.14So, you know, NUREG-1537 is your friend15for understanding what we're looking for.16The other thing, you talked about the ACRS17for similar application to yours. There are18transcripts of the ACRS meetings. You can go read19those transcripts and see what areas interest the20ACRS, what areas they focused on, where they asked21both us and the applicant questions and issues that22became, you know, issues that were sort of follow-on23issues.24So there is an advantage for you being25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 77second in the queue that there is information that's1available to you. And that's an important source of2understanding how the ACRS works, what they think,3what they look at, what they consider important.4MS. HELTON: Also publically, this is5Shana Helton again, also publically available on the6advisory committee is their charter. You know, I7encourage you to look at that. They're mandated by8statute. They're an advisory buddy to the commission.9The staff does not have much influence10over how they operate with their schedule. The11members need whatever information they need before12they'll go to a committee and write a letter.13So while we can attempt to work with the14ACRS and, you know, it's very difficult to try to15manage that schedule. They've got competing demands16and they only get together once a month. There are17certain months of the year that they typically do not18meet. So it tends to be fair.19You know, you see an August meeting up20there, I don't think they usually meet in August. 21Sometimes they make --22MR. LYNCH: Subcommittee does, full23committee does not.24MS. HELTON: Full committee does not. So25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 78I'm just saying, there is some limitations in working1with the ACRS. They have a statutory role to fulfill2and they take it very seriously.3So looking at those old transcripts can4help try to predict what, as they're membership5changes, you know, it's just, it's a variable that's6well out of the staff's hands. That's all I can say.7MS. GAVRILAS: This is Mirela Gavrilas. 8And we have, the staff has experienced working with9the ACRS. The staff knows the ACRS' schedule.10The ACRS itself, from our previous11experience, the ACRS too recognizes the importance of12this activity. Of establishing a reliable, domestic13supply of molybdenum-99.14So while there are challenges, they will15work with us. We know how to work with them. And16past experience says we've been successful to make17that as effective of interaction as possible.18MS. HELTON: Absolutely.19MR. BALAZIK: This is Mike Balazik. I20guess I just have one question. We've been, for the21environmental review, we've been through two rounds of22RAIs.23We have been sharing those in draft form. 24We've offered calls. I mean, is there more that we25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 79can do on these?1I mean, I guess I'm just kind of asking,2what can we do differently? We've been through two3rounds to help Northwest with the understanding of the4RAIs. I guess it's just a question that --5MS. HAASS: Yes, I don't think there's a6disagreement of we don't understand the RAIs. There7were actually, you know, we had a public meeting, you8know, when we did the site visit, there was some9agreement that the RAIs were complete. You did come10back and then say you wanted some additional11information.12Then there were quite a few additional13ones in the second round as well. And it was based14upon some additional information you asked for.15And so I do think it's complete. And it's16sitting here for you.17MR. BALAZIK: But it, this is Mike Balazik18--19MS. HAASS: Now, there really isn't20anything else we can do accept keep communicating. 21But remember, it wasn't until the EDO meeting, until22we requested that we have these weekly meetings here,23I'm sure that there was an understanding.24MR. BALAZIK: This is Mike Balazik again. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 80There's a difference between the weekly status call,1which is just overall --2MS. HAASS: I know the staff, knowing what3we had and where there is a question and how we would4go about resolving that. And it could be a public5meeting or it could be just, you know, there was a6misunderstanding and it was just a quick, you know, we7understood it.8MR. FOWLER: So I see three areas that9offer opportunities to explore expediting. The first10I'll call administrative in nature. And those are the11mandatory noticing periods, the number of meetings and12so forth.13The better we can be in advance of14understanding when those need to happen, we can15eliminate more time that's simply waiting for one of16these periods. Or waiting to have a meeting.17That's probably the most frustrating to me18is having to wait for things. I never want either19team to be in a position of waiting for things. 20Because that, by definition, is lost time in the21schedule. So I call that administrative.22Then there's this area of technical. And23what I'm -- I've heard the term, completeness used24sufficiently that it will be lodged in my memory.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 81And so -- and that comes through dialogue. 1In order to meet this threshold of completeness, the2technical teams need to be in communication so there's3no misunderstanding of what completeness is required.4And I want to test to see we have the5appropriate communications mechanisms in place, to be6sure we're meeting the completeness guidance.7Then there's the regulatory or precedent8guidance. Which comes to what I've termed threshold. 9What threshold do we need to meet.10And that's really on us. We've got to do,11and have been doing and will continue to do, research12into threshold regulatory.13So those are the three areas. Obviously14the last one is something that we have to work on15independently.16The other two I believe are areas to17explore whether we've done everything together that we18possibly can do to meet and better the schedule.19And I'm sorry, Mirela, you were going to20make a comment.21MS. GAVRILAS: Wow, that was, I'm taking22notes furiously because I want to answer to, to answer23a couple of things.24So let me go with, as far as the status25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 82meetings are concerned, that's our practice. So I'm1not sure when we implemented it, but I know that we2had the same --3MR. LYNCH: We talked about it in4November. Or no, actually August, at the National5Academy of Science --6MS. HAASS: It just didn't get implemented7until about a month ago.8MS. GAVRILAS: Okay. But that is part of9our practice. To have those status meetings. But10their status meetings do not touch on anything that11Nick just mentioned.12Okay. So as far as communication, that's13what I was writing. The regulatory guidance is the14first place to look to see what the yardstick is for15completeness.16Our discussions, discussions with the17staff are intended to augment that. Not replace that. 18So they come in addition.19And sometimes there's no additional needs20for communication. Sometimes there are needs for21communication.22So we need to work together. As soon as23you identify a need for further discussion, you need24to let us know. And we'll do our part in anticipating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 83when it's likely that you will have additional1requests.2Because, for example, if we know that3we're asking a broad reaching RAI, like Dave just4mentioned. If we're asking you something, what was5your methodology, then we can see how that would6require an interaction in the public to discuss7further.8So it's both sides. We both need to be9aware. And I think we can both, at least we can10committee to our part, to have that awareness and try11to be proactive.12MR. BALAZIK: Yes. And this Mike Balazik. 13And the whole idea of the status call, the weekly14status call, that was to be implemented as when we15accepted the application.16I didn't see it, weekly calls, before17that, until we got to that point of acceptance of the18application. So that was --19MS. HAASS: And that was a little20different understanding. But no, I'm just glad it's21done.22MR. BALAZIK: Okay.23MR. LYNCH: So, just to finish up with24this slide, did we help with understanding ways that25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 84we might be able to help accelerate the schedule in1terms of strategy? Any other questions do you have on2that right now?3MR. FOWLER: I think I have a good4understanding of the areas that I tried to summarize.5MR. LYNCH: Okay.6MR. FOWLER: And what I would like to see7and what I would ask of our team is, okay, now8translate those areas into a plan. What are the9processes and procedures that we've put in place, what10are the accountabilities, what are the milestones,11what in fact are the definitions of success or lack12thereof so we know we're on plan or off plan.13It's all about project management, once we14understand what the plan it.15MR. LYNCH: Okay.16MR. BALAZIK: All right, this is Mike17Balazik, I'll continue on. We want to go through18docketing. Steve mentioned earlier what docketing19was. And I just wanted to go through the timeframe20for docketing of the Northwest application.21First I'll start with the Part 1. 22Northwest submitted Part 1 of its application three23times. Once in October 15th, another time, 29th, and24November 7th of 2014. This was before providing the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 85NRC with a version that was acceptable for processing1and conducting an acceptance review on February 5th.2The NRC issued a letter to Northwest on3January 23rd notifying Northwest its application was4incomplete and unacceptable for docketing. Northwest5was allowed 30 days to supplement that application. 6And Northwest chose to withdraw the application and7resubmit. And that was the February 5th, 2015 date.8The reason for some of the delays was9inappropriate markings of proprietary information. 10Also, ADAMS had rejected the document due to numbering11of pages.12When they see a document has so many pages13and it doesn't match up, they'll reject the document14and try and get it resolved.15So Part 1 of Northwest's applications16accepted for docketing in June of 2015. And that was17approximately two months after successfully processing18it into ADAMS.19And just real quick on Part 2. They20submitted the application, Northwest submitted the21application, on July 20th, 2015. However, due to22formatting and improper proprietary markings, the23application was not fully put into ADAMS until24September 18th.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 86The staff completed its acceptance review1in the mid to late November 2015. And before2notifying Northwest on its acceptance decision, the3staff held a public meeting in late November. And4provided Northwest an opportunity to clarify its5requested licensing action.6Following the public meeting, the letter7of acceptance was issued in December of 2015.8One thing I would like to add is that9Northwest submitted large portions of its applications10in hard copy form, which lead to delays in processing. 11In ADAMS, when you submit 1,600 pages, it takes awhile12for them to process that.13Going forward, submission using the14electronic information exchange may reduce those15delays. I know that, Carolyn, you've expressed some16difficulties using that system, but I can provide you17a contact that can help you provide documents in that18form. So just --19MS. HAASS: So is, I'll put it this way. 20If you begin to do that, you have restrictions and21limitations. Because it is a very archaic system.22And because of that, the granularity of23graphics and pictures would not be coming out24appropriately. And it just absolutely made no sense.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 87And we had a lot of difficulty with your1system that we would have two different files, exactly2the same thing, one would be accepted and one3wouldn't. And we couldn't figure out why.4And it was taking too much of our time. 5That's why you saw the first part tried to be6submitted twice. Because we couldn't get it through7the electronic system.8You have a graphic capability of 300dpi. 9Our logo is more than 300dpi. And it's on every page. 10It just isn't worth our time.11MR. LYNCH: I believe the 300dpi is a12minimum, not a maximum.13MS. HAASS: No, it's maximum. I mean14there's some real difficulties. And we have a premier15person who does our documents, and I'm going to tell16you, it is one of the more difficult systems that17we've ever had to use.18MS. GAVRILAS: So --19MS. HAASS: You know, I don't want to take20this meeting over with that, and we can discuss it21later, but --22MR. FOWLER: This is an area, so fully23understand the dates. We're well aware of the dates. 24The report that I get from my team would characterize25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 88the difficulties differently from the way the NRC1characterizes the difficulties of receipt.2I think we can summarize this, that this3is an area that is, we should better understand4whether this can be improved. Because we sit here5today with another stack of paper, to respond to RAIs,6because of my teams perceived inability to work with7the electronic submission system. That's a problem.8Now it could be us, it could be the9system. But let's take it off and figure out how to10fix that.11MS. GAVRILAS: Just a point of12information. Quick one. The system is designed the13way it is because the intent of the system was to14enhance transparency. So that the documents can be15viewed on the processors that were prevalent at the16time at which it was deployed.17MS. HAASS: Right. And that was the18issue.19MS. GAVRILAS: So it was an optimized --20MS. HAASS: Right.21MS. GAVRILAS: -- optimized two aspects of22our mission. One is, openness, reached the broadest23set of stakeholders. And the other one is, making it24easier for our stakeholders, for another set of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 89stakeholders, the applicants and licensees to use.1MS. HAASS: Right. I mean it is a catch-222, but we also had to get to a point where we did it3the easiest for us because it would, you know, if you4have to take every graphic out and do everything5individually and save it individually, it becomes so6cumbersome that you will make more mistakes.7So we can look into it, you've heard my8comments on your system, and there's lots of room for9improvement on that side as well.10MS. GAVRILAS: Noted.11MS. YOUNG: Well perhaps we can get them12in touch with or possibly with somebody can stop in13today and just give a general explanation of the14electronic filing.15MS. HAASS: We --16MS. YOUNG: Because my understanding is,17not only do people submit by transmitting18electronically, but they also put information on the19CDs. But if the CD files meet the format, it can be20easily put in.21And applications like --22MS. HAASS: We do put a --23(Simultaneously speaking)24MS. YOUNG: -- requirement.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 90MS. HAASS: We've tried the CD submission. 1But, you know, we have talked with them. We can do2that more in the future.3MS. YOUNG: Because I know you're4interested in saving time. And any unnecessary --5MS. HAASS: Yes, but we're not going to6solve either problem today.7MR. BALAZIK: I think this is a good spot8to take a quick break. Next we'll go into Part 70.9So ten, 15. Let's take a 15 minute break10and start at 10:30. All right, we're going to go mute11on the phone and we'll be back at 10:30. All right,12thank you.13(Whereupon, the above-entitled matter went14off the record at 10:14 a.m. and resumed at 10:3315a.m.)16MR. BALAZIK: Good morning. This is Mike17Balazik again and we are going to resume the public18meeting.19Right now we are on Slide 36, the NRC20Licensing Process. This is, we're going to be21discussing Part 70 and I'll turn it over to Dave22Tiktinsky.23MR. TIKTINSKY: Okay. Thanks, Mike. I'll24kind of make a point, my presentation is generally25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 91more, you know, general Part 70, but I have a couple1of things that came up from this morning's discussion2that maybe will help sort of set the frame.3Some of it is some of the keys to4effectively, at least on the Part 70-type things, is5making sure there is a good understanding of6applicable regulatory requirements.7So we talked a lot about RAIs, that's sort8of the finer thing after you submit something, but in9the case of Part 70 is making sure you understand the10requirements and if you, you know, if you understand11them then obviously when you submit an application12related to those things you'll be able to, you know,13hit the mark better.14And, of course, if there are any specific15questions related to applicability of specific16sections of Part 70, how it gets implemented, then,17you know, the form of pre-application, public meetings18that we've had on other things for the Part 50 part,19you know, may be appropriate.20So that's some other ways of making sure,21you know -- You know, a lot of the discussion was, you22know, you give us a quality application, well in the23CP you have already given us an application, so24whether, you know, maybe you would have done something25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 92different in the future, it doesn't really matter now1if that's already there.2For other future applications you can take3a lot more of that into account of the experiences4that you'll have with the CP as well as the other5experiences that we talked about for other facilities6to try and make sure, you know -- You know, the best7way to minimize, you know, RAIs is to hit the mark as8much as you can.9So just sort of to get started on Slide1037, just a little bit about Part 70 requirements. You11know, Part 70 is relatively brought up if you have12broad regulation to cover a whole bunch of different13things and it talks about, you know, establishing14procedures for issuance of licenses, you know, to15title to own, acquire, deliver, receive, possess, use,16and transfer.17So that's a quite a lot of different that18it covers. There is a lot of activities that are in19there related to, you know, possession and use. There20is the scrap recovery and licensing a fuel cycle21facility.22So that's, it's a -- Again, it's a fairly23broad regulation to cover a lot of types of facilities24and activities for special nuclear material.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 93The next slide, Slide 38. It's a good1example here of, you know, kind of in parallel to what2Steve talked about in Part 50, and these, again, not3to, tend to be comprehensive, you know.4The regulations in 70.21 what the5application should be, how to file it, that, again,6emphasize the fact that you can incorporate7information by reference.8So if there is information that you9already provided for your other parts of the facility10you don't need to repeat them, you can just reference11them.12Again, the clarity of those references13helps the reviewers a lot, you know, the use of14crosswalks, tools, you know, whatever is efficient.15We want to make sure that the reviewers16know where the information is, know how to find it,17find it quickly, you know, and shows how it meets18those particular regulatory requirements.19It also has allowance to, if in Part 70 in2070.21(b) that you can have other licensed activities21specified in regulation, as long as the specified22regulations are met.23So, again, it's the combining of24applications and licenses. It's not just in 50, it's25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 94in 70, it's in other parts, so you are allowed to do1that.2Again, the biggest emphasis that I will3have on that is regardless of the form that it turns4out you need to be able to demonstrate that the5regulatory requirements are met and the clearer that6is demonstrated the easier it is to get through the7review process and then timeliness for that.870.22, the content of applications, there9is various requirements in there. 70.23 talks about10approval, so, you know, 70 is a little different than1150, the requirements are somewhat different, the12findings are different, but they are sort of still in13parallel to the, you know, public health and safety.14So it's the same theme even if some of the15details are different. I think related to criticality16accidents, for example, you know, criticality17monitoring systems and the applicability of, you know,18subpart (h) which has additional requirements for19certain types of licenses authorized to possess20critical mass and material.21The next slide, Slide 39. So NUREG-1520,22which is the standard review plan that we use for a23fuel cycle facility license application, the first24thing to think about is the information that's in 152025NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 95shouldn't be, you know, that much different than what1you've seen in 1537, the augmented ISG, because a lot2of that was taken from 1520 and some of it just copied3for the applicable portion so a lot of it is the same4types of methodologies that you would use for the Part570 application under 1520 or already in 1537.6So it's not like you would have to7demonstrate using different approaches for Part 70,8it's the same approaches and then -- or 1520. Again,9the regulatory findings that are discussed in 152010talk about Part 70 regulatory findings.11The regulatory findings in 1537 talk about12the regulatory findings for Part 50. So that's sort13of where the difference the staff in its review of14Part 70 applications has to make Part 70 findings for,15so it's sort of, you know, tailored to the specific16regulation.17The document, you know, provides guidance18to the reviewers, perform safety environmental19reviews. Again, you are not required to follow what's20in there, you can propose alternatives with21justifications, certainly perfectly acceptable.22Things that are usually smooth, if you're23trying to go, you know, veer a lot from what's in24there and you have to prove it, and your case may be25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 96difficult, it may take more time.1Again, it's not a definite on that. It2is, again, depending upon what it is and what is your3approach and what's appropriate for your particular4facility.5Following formats that match something6that we recognize are easier. Again, the easier we7have to track the information that we need, the easier8the review goes.9It also provides guidance for various10things, you know, new facilities, amendment renewals,11a lot of different activities, but the activities are12similar to the things that you are doing under, in13Northwest.14So it's not a foreign -- 1520 relates very15directly to the kinds of things that you are doing16that would be in your application, so a lot of it is17applicable.18It also makes references to other NRC19guidance documents, some of them like 1513, which20relates to the ISA, Integrated Safety Analysis21Guidance, which, again, what's in 1537 refers to the22same to documents, so, again, it's not a foreign23concept of what it is referring to.24The next slide, Slide 40. So sort of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 97purpose of, you know, why we even have an SRP it's,1you know, if you have a, it's across the board for2quality uniformity of review.3We want -- It's guidance for the staff of4what they should be looking for and how it should be5looked across various facilities so we treat everybody6the same regardless of what type of facility it is.7At least in uniformity the review would be8the same even if the information may be different9based on specific requirements in the regulations for10a specific type of facility.11Again, it's the guidance related, it's 12meeting the underlying objectives and the regulatory13requirements, so there is more information in there. 14Again, if you look at the regulation it talks about15the kinds of things you have to do.16The idea of having the SRP is to give more17guidance and details of some of the kinds of18methodologies and approaches that the staff would find19acceptable.20As I mention this flexibility, you don't21have to follow it, but you have to, you can provide22alternatives and also address it as, you know, Part2320, Standards of Radiation Protection, and Part 70.24You know, Part 70, what's somewhat25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 98different than Part 50 is, you know, the chemical-1related hazards that are considered in Part 70 based2on the nature of the activities that are done under3Part 70 facilities.4Next slide, Slide 41. So the guidance5that we have in the regulations of 70.31 for issuing6a license, so once we determine that all the7applicable regulatory requirements are met we can8issue a license in the form and then you will have9conditions as appropriate.10You know, conditions, for example, may11relate to, you know, you have to A, B, and C before12you can have material. There may be other things. 13Again, as we do the review and we see where you are14there may be specific requirements of things that we15would put in in the license conditions.16We have done this for other facilities. 17Again, it's not different than any other fuel cycle18facility. If you look at other fuel cycle facility19licenses you will a series of some standard conditions20and then other ones that are specific to that21facility.22So we would expect something to be here23for this, this particular activity also. Even in a24combined license you still have license conditions25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 99that you find in there.1So then we would -- Again, if it was one2piece of paper you would still find the same technical3conditions, license conditions in that piece of paper.4Next slide, Slide 42. So, you know, how5does the applicant demonstrate, and let's say that the6regulatory requirements are met, we talked a little7bit earlier about, you know, how you do that. So you8can, you have a choice.9You can combine it with the Part 50,10Production Facility Applications, in the case it could11be the OL. Again, where it's not specific of exactly12when you would submit that document you could do it as13a standalone document. Again, you choice.14The key thing, again, I'd like to emphasis15is you have to demonstrate the regulatory requirements16are met and if you are going to use multiple17applications in different places then, you know, the18easier you make it for the staff to know where those19requirements are found the easier the review will go.20MS. HAASS: Will you be doing a separate21safety evaluation report from 70 to 50 even if it was22combined, if it's separate you would do them23separately, if it was combined would there be one? 24How would that work within the NRC?25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 100MR. TIKTINSKY: Well part of it is, and1exactly where and how many documents sort of depends2upon how you submitted it to us, but we --3MS. HAASS: But it was combined?4MR. TIKTINSKY: We would have to make, our5SER would have to make combined regulatory findings if6we were making the regulatory findings on the Part 507side.8MS. HAASS: Okay.9MR. TIKTINSKY: We would have conclusions10for the Part 50 part. We would have to make11regulatory conclusions in the same document for the12Part 70 part.13So we would have to make sure we had them14all in there, that they were comprehensive. So just15like you would need to demonstrate that you met all16the applicable regulatory requirements, our SER would17talk about the staff's acceptance, the reasonable18assurance, for all those regulatory requirements.19MR. FOWLER: More pertinent to the20previous conversation is does one pathway offer an21easier, faster schedule than the other pathway?22MR. TIKTINSKY: It's hard to say in terms23of the speed. Clearly, the easier you can make it on24us to understand what you are doing and, you know, not25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 period1between submittals of one and the other then, you2know, tech reviewers that reviewed one part have to go3back and look at it to make sure they have covered it.4So there is some efficiencies in having5the same people looking at both aspects at the same6time. So I know about that --7MS. HELTON: If we go ahead a couple of8slides I think we're going to get to that, too, but9Dave is also going to talk about the differences10between the 2-step Part 50 license and the 1-step Part1170 license.12So Part 70 is a 1-step licensing process,13so there are some differences and the key I think is14ensuring that whenever you seek to fulfill the15requirements of Part 70 that you provide all the16information.17MS. HAASS: Right.18MS. HELTON: There is different -- You19know, you have seen that the bar for the construction20permit, it's a different bar, you don't have a design21set and --22(Simultaneous speaking)23MR. FOWLER: And this is why from -- I24have narrowed it, the choices in my mind are narrowed25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 102to two because we have to have all of our finalized1design complete for the operating license under Part250, which is then a 1-step process because the first3step has been complete, or we submit it under Part 70.4So if I make my question more precise, is5there a difference between providing the same6information, meeting all the regulatory hurdles under7the operating license for Part 50 in contrast to a8separate application on your Part 70?9MS. HELTON: It might be helpful to step10forward in the slides and see if we don't address11that.12MR. TIKTINSKY: Okay. Yes, see if we go13through and see if I answered the question or not.14MS. HELTON: Yes.15MR. TIKTINSKY: How about that?16MR. FOWLER: Okay.17MS. HELTON: Sure.18MR. TIKTINSKY: So, and, again, just the19thinker that if they are combined then we need to make20sure how they are met so it's clear to reviewers.21Forty-three. So to sort go with what we22have looked at, so from what we have received in the23docket so far the staff doesn't believe we have24sufficient information to do the conduct review of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 103target fabrication scrap recovery activities right1now. So I think --2MS. HAASS: But it was never expected to3be at that level.4MR. TIKTINSKY: Yes. So it's just that,5that's my understanding that there was not.6(Simultaneous speaking)7MS. HAASS: Yes.8MR. TIKTINSKY: We just want agreement9then, we all agree that there is not, we don't believe10there is sufficient information.11And from our review of those activities,12you had mentioned in your application that you13believed they were under Part 70, so how we look at14them they, I guess the first part is they don't appear15to be covered by Part 50, so that's sort of, it's not,16it doesn't meet the definitions of production facility17under Part 50 and they appear to be subject to Part1870.19So that's sort of our looking at what --20Even, again, you have not submitted the application,21so it's hard for us to make a definitive, you know,22determination of what is there without that, but23that's what we believe at this time.24And for us to actually conduct, you know,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 104the safety review and issue a license, because1obviously you would need to submit an application2meeting all the regulatory requirements.3And the burden is always on the licensee4to demonstrate that they, or the applicant and the5licensee to demonstrate that they meet regulatory6requirements.7The staff does findings of reasonable8assurance that you do meet them to protect the public9health and safety, but the burden is on the applicant.10Sort of in addition to or in lieu of for11some specific licensing questions related to, you12know, specific aspects of what's applicable, you know,13we talked we talked about pre-application meetings.14We would like to know, you know, if you15believe certain parts of Part 70 are applicable or not16applicable and have why they are not applicable we can17have pre-application discussions of them.18Again, going back to my first point of19making sure there is a good understanding of things20because for any facility pretty much in, or activity21in Part 70, there are some parts that apply and some22parts that don't apply just on the nature because Part2370 is a broad regulation.24You can, you know, control things like MOX25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 105facilities, which is different than, you know, uranium1enrichment facilities, so there -- But the regulation2is written broadly, so, you know, your understanding3of what you think you need to meet, having discussions4on that would probably be useful to make sure we were,5you know, had some alignment, you know.6We don't want to play the bring me rock7where you just, you know, send something in and we say8no, you missed the mark, so we want to have those9discussions because there where you add to timeliness,10or had the time to doing a review if you do that.11So, you know, as we have mentioned, you12know, many times those communications and13understandings are really important to make sure we14hit the mark.15But, again, it is, you know, Northwest's16responsibility to demonstrate what they think they17meet, what you think activities apply, what18regulations do you think you meet, and how are you19going to demonstrate that they are met.20The Slide 44 talked a little bit about21schedule and, you know, Steve had presented a schedule22to you, and that was a very good outline of the types23of activities that get done in a review, so what I24present here is sort of, you know, if you were just25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 106submitting a Part 70 application this is what we would1tell you that, you know, it's typically about 182months to do a review.3We do a technical review of the4application. Again, whatever it was, if it was5submitted with the Part 50 or not we will do a6technical review of the applicable regulatory7requirements, issue additional requests for additional8information, draft a safety evaluation report, you9know.10There is slight differences in terms of,11you know, the process and terms of, you know, there is12not a mandatory hearing for this type of facility in13Part 70 compared to 50, so there's some, you know,14subtle differences.15But I guess the major point here is the16review can be done in parallel or a series, so it sort17of depends when you submit it.18So the 18 months I show here, you know, if19you wait until after you submit it and we reviewed an20operating license application under Part 50 then you21sent us one then that clock would start when you22submitted it.23If it's with it then we could do that24review in parallel, so it wouldn't be adding to the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 107time.1So, again, a lot of it depends upon where2you want to submit it, what is strategic, you know,3for your company, when you think you are ready to have4all the requirements.5And, again, in Part 70 the 1-step license6requires, you know, a further development of things7than a construction permit and it is also slightly8different than what's in an operating license.9Again, the regulatory requirements are10different so it doesn't necessarily line up 10011percent but it is your choice to, when your12information is available, that you think you can meet13to demonstrate the Part 70 then you can submit it.14If that happens to be with the operating15license that's perfectly acceptable to us. If it16happens to be before or after, I mean, again, that's17acceptable, you know.18Again, the key is to make sure that, you19know, you have an application that's complete, that20has all the applicable regulatory requirements21addressed.22MR. LYNCH: And just to add on, and I23think Dave is absolutely right. I guess what it comes24down to, I'm glad we're in agreement on the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 108information itself that needs to provided and I think1that the main comment in terms of what's more timely,2the sooner we have the information the sooner we can3begin reviewing it, if that helps you in planning when4you submit.5But I think from a Part 50 standpoint it's6important to think about, also, that is there still7related activities that are happening under the same8roof.9So in order for us to make our safety10findings under Part 50 for a production facility we11will be interested in how other activities happening12within that building could impact, and I'm sure it's13the same going both ways.14So while you can submit the information15whenever you would like to, it's all related and we16need to know the impacts that those activities will17have on the different, within the building on the18different other activities that are happening as well,19and whether it's the manufacturing of the targets or20the processing of those targets.21MS. HAASS: Well and that was the concept22of our Part 1, Part 2 submission was we showed an23overall facility, because you are trying to show all24the safety-related activities, you know, and how they25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 109interact with one another.1MR. LYNCH: Yes.2MR. TIKTINSKY: Yes, it sort of emphasizes3--4(Simultaneous speaking)5MS. HAASS: But I can't do one without the6other?7MR. TIKTINSKY: Yes, to emphasize Steve's8point, I mean we, you know, individually look at the9Part 50 portion of the facility we need to consider,10you know, an external, which isn't really external in11this case because it's maybe the room next door.12But you still have to consider those13activities in the Part 70 one and on the 50, and just,14and the same way we would, if you were just looking at15just the 70 piece in isolation we would be interested16in the impacts of what the Part 50 facility around it17was impacting on that in terms of, you know, accidents18and analysis and things like that.19So we would look at it both ways because,20again, we have to make a regulatory finding for those21specific parts of the facility for those parts.22MR. JOHNSON: So, Nick, did that answer23the question that you asked a couple slides back about24are there efficiency -- What a thought your question25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 110was, are there efficiencies with going one route1versus the other, submitting a separate standalone2Part 70 versus incorporating all of the, how you are3satisfying all of the requirements into the CP, is4that what you were asking?5MR. FOWLER: Yes. And, further, is there6a material difference between the strategy of7application submission?8And what I concluded from the conversation9there is not a material difference between submitting10under a construction, or an operating license out of11Part 50 in contrast to a separate and distinct Part1270, the same steps, that it's not going to be easier13for the NRC.14In many companies it would be easier to15have a separate Part 70 application because some of16the conversations could be more easily17compartmentalized even though they do relate to other18things.19What I concluded, rightly or wrongly,20there is not a material difference. And to be clear21from what's in my head there is a 2-month difference22right now between the critical path of us entering the23supply chain with quantities of moly under Part 50, a242-month slip on the Part 70 puts Part 70 on the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 111critical path. That's how tight these two things are1together.2Plugging in all of the assumptions from,3well the guidance that we receive from the NRC, there4are only two months difference right now and so if5there were a material difference in review process6cycle time it could very easily affect the entrance of7this critical isotope into the supply chain.8That's how granular -- I manage the9schedule. We're down to a month.10MS. HELTON: So I think, you know, we've11emphasized the importance of communication on both12sides. You know, you want the frequent public13meetings, we can do that.14And I think what would be really helpful15is to have a public meeting or a series of pre-16application meetings where as you solidify your plans17for your operating license and meeting the Part 7018that, you know, you keep us in the loop about how your19project plan is starting to -- and we don't need20those, necessarily all the details, but just in terms21of what you are thinking about how to meet the22requirements and going forward.23I've seen another complex application, I24was in operating reactor licensing before this job,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 112where, you know, we've had as many or seven or eight1pre-application meetings to talk about each of the2different technical chapters and what they're going to3be doing to meet the requirements, and you might want4to consider doing something like that just so there is5no surprises.6MS. HAASS: And we have done that in the7past.8MS. HELTON: Yes.9MS. HAASS: Yes, so --10MS. HELTON: Yes.11MS. GAVRILAS: So just one reminder. This12is Mirela again. Just one reminder that these are13estimates, the timelines, and we try to walk you14through the parameters, that impact held with that15estimate that --16So it's almost like you are talking17project management, what we visualize in our mind is18sort of Gantt chart with the end in mind, you know,19how the review of these various activities basically20lead towards the point that which you get an operating21license.22MR. BALAZIK: This is Mike Balazik. Is23there any other questions on the Part 70 piece,24because now we're going to shift to something else?25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 113MR. ADAMS: And now for something1different.2MR. BALAZIK: All right, Al.3MR. ADAMS: So what I'd like to do is, you4know, we have discussed the, you know, general5requirements for licensing, your proposed activities,6you know, we discussed where the current status7review.8Using your cover letter for Part 2 of the9application and the NRC reply I'd like to try to pull10everything together and hopefully the goal here is to11reach a common understanding of how to move forward.12I am, you know, because of the excellent13presentations that came before me, you know, some of14this, you know, some of what I am going to say will be15redundant, but, again, repeating it in the light of16your application requests.17So, next slide. So, you know, here is I18think probably the most important statement from, well19one of the important statements from your cover20letter, that you are applying to the NRC to obtain a21license for a production facility under 10 CFR Part2250.23So, next slide. So I think, you know, we24understand that statement that you are looking for a25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 114construction permit for a production facility, you1know, to dig a little bit deeper that you are looking2for a license to construct a facility where you plan3to conduct activities to separate moly-99 from4irradiated uranium and other byproduct material.5That's consistent with the third6definition of production facility in 10 CFR 50.2. 7There is three basic definitions of production8facility.9One is facilities that are involved in the10formation of plutonium, basically plutonium production11reactors. The other one are facilities that are12primarily separating plutonium, and there is the third13definition which is on the slide, any facility design14or used for the processing of irradiated materials15containing special nuclear material.16(Off the record comments)17MR. BALAZIK: This is Mike Balazik, please18Star 6 your phone to mute it. We can hear some19background conversation.20(Off the record comments)21MR. BALAZIK: This is Mike Balazik. We22are picking up some background conversation. I ask23you please mute your phone, Star 6.24MR. ADAMS: And there is, you know, there25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 115is a safety reason behind the definition and that's1when you are processing irradiated materials2containing special nuclear material basically you are3separating out fission products from irradiated4special nuclear material.5That involves additional hazards from what6you would see in what I would call traditional fuel7cycle facilities, the fact that you are dealing with8irradiated material.9You are dealing with fission products,10radioactive material, gaseous fission products, which,11you know, which creates different accident scenarios12and potential for dose.13So that's sort of the theory and the idea14is once you introduce these irradiated materials that15your intensity of our Part 50 where we are interested16not only in the materials, the licensing of the17materials, but also the licensing of the facility that18contains the materials.19The third definition does contain some20exceptions and you have indicated that you are not21looking to license under any of those exceptions and22those exceptions are that basically your separation is23being done on a laboratory scale, so that's the first24exception.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 116The other one is if you are, that if your1batches are less than 100 grams of uranium then it's2not a production facility. You indicated that your3batches will be greater than 100 grams of uranium.4And the third is that if the irradiated5material that the fission product concentrations and6the plutonium concentrations are less than the cutoffs7in the definition then you are not a production8facility.9So you indicated that you are not looking10to fall under any of those exceptions, which means you11are a production facility under Part 50.12Next. So here is another statement in13your letter to us.14(Off microphone comment)15MR. ADAMS: Oh, I'm sorry. Yes, that's16what it says here. So, I'm sorry, this is our letter17back to you where we completed the review and we agree18that you have an application for a construction permit19for a production facility as defined in 50.2 and20you've met the requirements of 2.101(a)(5) and the21information required by 50.34 and we found your22application acceptable for docketing.23So based on that we are going ahead and24reviewing the application for the production facility. 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 117Okay, now Slide 49.1So in your cover letter you discussed your2intent to apply for a single part, a 10 CFR Part 503license. You indicated following NUREG-1537 and you4also referenced the regulations in 50.31 and 50.32.5Slide 50. So just to repeat what 50.316and 50.32 say, so the regulations in Part 50 allows7combining of applications under Chapter 1 of 10 CFR8and Chapter 1 is all of the NRC regulations, so we,9you know, so applications can be combined.10And there is a regulation 50.32 and there11is a parallel regulation in Part 70, 70.21, and they12allow an incorporation by reference information13contained in, you know, previous applications, other14information. The requirement is that the references15are clear and specific.16Slide 51. So your cover letter referred17to NUREG-1537. I assume that when you say NUREG-153718you are referring to the ISG, that augmented 1537 --19MS. HAASS: Correct.20MR. ADAMS: -- which provides applicable21guidance for licensing radioisotope production22facilities and aqueous homogenous reactors, you know,23the guidance on aqueous homogenous reactors isn't24applicable to your proposed facility.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 118NUREG-1537 has a couple of statements that1are applicable to what you are proposing on doing2here. Section 9-5 of NUREG-1537 contains guidance3that materials used in the production facility license4need to meet the regulatory requirements for that5material. In other words, special nuclear material6needs to meet the regulations in Part 70.7NUREG-1537 also says that materials8required to operate the utilization of a production9facility can be included in the license and this10permits the combining of licenses.11Fifty-two. So your cover talked about 12embedded in the 10 CFR 50 license facility activities13under Part 70 and Part 30.14Slide 53. As I mentioned, as discussed in15Section 9-5 of NUREG-1537 the Part 50 license can16include other activities, however, the issuance of a17Part 50 license doesn't automatically include other18activities, other licenses.19For example, you know, Part 70, Part 40,20Part 30 licenses. These licenses are combined only in21the Part 50 license if the applicant has submitted the22needed information and the applicable requirements.23So I think as we said several times, at24this time we don't believe that your construction25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 119permit application has the information required to1grant the additional licenses and I think we're2looking for a better understanding of what you mean by3when you say "embedded activities."4Next slide. So this is an example of a5Part 50 utilization of an operating license. We call6them included activities. What I am looking for is to7understand if our included activities are the same as8your embedded activities.9As you can see in this license the10different licensing clauses. Number 1 on this slide11that is the license for the facility, so that's where12the license is granted for the Part 50 facility. This13is an example of a Class 103 license, which is similar14to the Class license you are looking for.15Where you see the three dots, where you16see the dots there and that phraseology, that just17listed who the licensees were and for this particular18facility there was a very long list of applicants.19And so Number 2 is you see an included20activity, so you can see this is the Part 70 clause so21the included activities to receive, possess, and use22at any time special nuclear material, in this case23it's reactor fuel in accordance with the limitations24for storage and the amounts required for reactor25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 120operation as described in the application.1And you can see in Number 3 there is Part230, 40, and 70 license to receive byproduct, source,3and special nuclear material falls under other uses,4neutron sources for startup, sealed sources for5instrumentation, calibration, radiation monitoring,6fission detectors.7Number 4 is a clause, it's a reactor8clause. It's Part 30, 40, and 70, you can see, to9receive, possess, and use in any amounts is required10in any byproduct source of special nuclear material,11so you can see the included activities.12C is just a reiteration that even though13it's a Part 50 license that the activities under the14other parts, 40, 30, 70, need to follow those15regulations. So that's how these concepts are put in16place in the license.17So, 55. You mention that the RPF will18include the fabrication of LEU targets which will be19licensed under 10 CFR Part 70.20Fifty-six. So, you know, we understand21that, you know, you understand that the fabrication of22targets is under 10 CFR Part 70 as we discussed23several times and this was reflected in our docketing24acceptance letter which stated that staff expects that25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 121and Northwest will submit an application for1fabricating low-enriched uranium targets under 10 CFR2Part 70.3And next is 57 --4MR. FOWLER: So I want to --5MR. ADAMS: Yes?6MR. FOWLER: Al, I I'd just to clarify7that.8MR. ADAMS: Sure.9MR. FOWLER: Part of what triggered a10serious of conversations was the meeting immediately11preceding Thanksgiving in which our internalization of12the communication was a requirement to bifurcate our13application between Part 50 and Part 70.14I was on the phone and I explicitly heard15that there would be a separate requirement for a Part1670 application, where previously we had socialized,17and I'll use the term socialized because it was only18discussed, socialized and put embedded activities, our19assumption that everything would be under Part 50.20So now 2-1/2, three months later I'm21understanding the language differently, which so long22as the information is there it can be either under the2350 umbrella or separate.24MR. ADAMS: It's still that type of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 122license, but, you know, there is choices on how you1put in your application, there choices on how the2license looks.3However, to get from Point A to Point B we4need to follow the regulatory lane for that activity. 5In other words, because I give you a Part 50 license6it doesn't automatically spawn these other licenses.7The Part 50 license by itself is a, you8know, is a license for a very expensive building9without, you know, without the other, you know,10without possession of material that building doesn't11do very much.12So I think that's the nuance that I think13we kind of missed in the conversations back and forth,14and I hope we have clarified.15MS. HELTON: Yes. Just to add to that, I16agree. This is Shana Helton for the phone. The point17I think back at the Thanksgiving meeting that is being18reinforced today is that we need to see something from19you that demonstrates compliance with the requirements20in Part 70.21MS. HAASS: There was --22MS. HELTON: Right. So I think that's --23(Simultaneous speaking)24MS. HAASS: Right, but there was never any25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 123disagreement with that when we were socializing it1when we had originally sent our letter over a year2ago.3MS. HELTON: Right.4MS. HAASS: There was no disagreement on5that, but there was a 1-step process versus a two, you6know, and, you know, there is a nuance and, you know,7we agree with that.8I mean what we need to do today is move9forward and we understand completeness, we understand10compliance, and we will get back with you on how we11plan on dealing with the Part 70, if it's going to be12combined with 50 or not.13MS. GAVRILAS: This is the main objective14of this meeting. We need to make sure that all the15areas where there is uncertainty, where we are not16aligned, today is our opportunity to address them.17You know that's why we exchanged the18topics that we covered today with Carolyn before the19meeting to make sure that everything that we are20presenting here does address your concerns and does21actually get us to the point to which we can align on22the things that have some uncertainty associated with23them.24MR. FOWLER: And so to that point I see25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 124everyone's head nodding that we are now in alignment1with respect to the previous kind of crosswise2communications on 70 and 50 and for that we can3successfully tick off that as we have met that4objective of the meeting.5The second and broader objective of the6meeting was to explore how we ensure that we most7efficiently accelerate the schedule to meet the needs8that we all recognize in the United States.9So I appreciate that we can tick off that10first objective of the meeting successfully.11MR. ADAMS: And I think I have one more12slide. Number, I think Slide 57. So that the current13application that you are not, at this point you are14not seeking an operating license for the proposed15facility.16This is a discussion we would like to have17with you today to the extent, you know, that we can18have it as to what your plans are for submitting your19operating license application because that does20influence timing, that does influence, you know, what21we do on, you know, what we need to do and what you22need to do, too.23So, you know, that's an area that we need24to, that we'd like to understand better for, we're25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 125prepared.1The second point, current application does2not request a license to produce SNM for the3fabrication of LEU targets, I think we beat that one4into submission.5MS. HAASS: Well it doesn't, it's not a6current operating license application.7MR. ADAMS: That's right, it's not.8MS. HAASS: It's Part 70.9MS. HELTON: Right.10MR. ADAMS: Yes. That's right, and that's11a separate point from my first one.12MS. HAASS: Right.13MR. ADAMS: And a facility can have14multiple licenses, that a single building can be a15place of use under multiple licenses.16When I was a licensee my containment17building was a place of use under my reactor license,18it was a place of use under our NRC SNM license, it19was a place of use under a state byproduct license.20The important thing, which I think Dave21and Steve alluded to, is we need to look to make sure22that those multiple activities don't impact the safety23of each other.24MS. HAASS: Yes.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 126MR. ADAMS: So that's the important thing,1but there is no rule that says that, you know, a2certain piece of turf can only, you know, can only be3occupied by one license, and I think that is4consistent with what we have discussed today.5So like I said I think the, you know,6before the day is out we would like to discuss, you7know, what are, you know, your plans for moving8forward with your operating license application for,9you know, for we understand them and we can be, you10know, prepared.11That's it for me.12MR. BALAZIK: All right. Real quick, this13is Mike Balazik again, and I know we have touched on14some of these topics but I just want to reemphasize15them.16On communications, that internal and17external communications is important to support a18quality and timely application review. I just wanted19to go through some of those channels that we have20already set in place.21One that Shana mentioned early in the22meeting about essentially one-stop shopping, that I am23your contact even though you've got, down the road24there is potential licenses, I am your main contact,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 weekly1status calls I'll have Dave and Nancy on those calls.2The next item, clarifying, calls for REIs. 3We've done a couple of those for the environmental and4we plan to continue those for the safety, sharing5those RAIs with you draft form, make sure there is an6understanding, and if there is not, you know, we can7discuss it and even modify the RAIs so that it is8clear.9Since we are discussing RAIs I'd just like10to share one item for thought going forward. Even11though there is no regulatory requirement to update12your PSAR, we've seen a good practice, or identified13a good practice that if you update your PSAR with the14RAIs that that can also lead to a timely review, but15even future steps it will help us, to keep your16updated PSAR.17But realize there is no, you know --18MS. GAVRILAS: I'll just mention one19thing, ACRS. It's easier for the ACRS, we accept your20responses, right, as a supplement to your submission,21they become part, they are docketed and they become22part of the docket.23It makes it much easier when the ACRS24looks at the package to have the package as complete25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 128as possible.1We were talking about places where2efficiencies can be realized, that's a place where an3efficiency can be realized.4MS. HAASS: So a good example is the RAIs5we have received on Chapter 19. We've already updated6Chapter 19. You have not received it, but we have7already updated it.8We actually when we get them we do it9right then and there. I am more than happy to provide10you an updated 19 if you want it right now. I don't11know why we'd need it right at the moment, but we will12be providing a revised PSAR with all the RAIs. It's13already in the plan.14MS. GAVRILAS: That's terrific.15MR. TIKTINSKY: The practice that we find16that works a lot is sometimes, you know, answers to17RAIs are long but changes to the applications don't18necessarily, aren't -- Well you might change one thing19in an application and have a 3-page thing backing it20up.21MS. HAASS: Right.22MR. TIKTINSKY: So at the end of the day,23at the end of the review it's good to have one24application that we know everything that's in the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 129application that we can write an SER against rather1than writing SERs against all these little sort of2sidebar discussions.3So, again, as Mike said it's not a4regulatory requirement but it's certainly an5efficiency that we found in not only 50 reviews but6certainly in 70 reviews also.7MS. HAASS: But remember it's difficult8for us to manage if we don't do that. That makes us9inefficient, so it's only good practice on our part10and to move forward to the operating license.11MR. TIKTINSKY: That could be changed12pages, you know. It doesn't have be, you know, every13time you make something it doesn't need a whole14chapter, it's just whatever related to, you know, the15change from an RAI and is, you know, and you manage it16however you find most efficient.17MR. BALAZIK: All right. Another item,18responsiveness, we've also talked about that,19especially timely response to RAIs and when we share20the draft RAIs if there is something that you see in21there that you can't get in 30 days or a certain22timeframe just let us know.23Let us know that this, hey, we can answer24RAIs 1 through 5 but, you know what, six is going to25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 130take us a little bit longer. You know, we just need1that communication back and forth that there may be2something up there that may take a little bit longer.3Quality of submissions, we also talked4about this, identifying proprietary information,5removing that, and just that answers are complete.6Also, just clarify previous communications7or socializing. We mentioned this earlier that no8regulatory decisions are made in public meetings and9that public meetings are not a substitute for10submittal of information on the docket and also that,11you know, we don't make decisions on our weekly calls.12And, finally, just that the NRC has an13opening policy and if we chose to close a meeting, you14know, it's reserved for information that must be15withheld in accordance with our regulation.16So that's pretty much it for17communications. I don't know if anybody else wants to18add -- Yes?19MR. LYNCH: I just wanted -- I was really20glad to hear that we were able to meet one of your21objectives in terms of licensing, that we have a22shared understanding that additional technical23information is needed for, to meet Part 7024requirements and how you choose to submit that is up25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 131to you and regardless of how it is submitted it's1still the same technical information that we are2looking for. I'm glad we've got that objective met.3I want to make sure that we can also4hopefully meet that second objective that you stated5at the beginning, which was exploring mechanisms to6expedite the review.7I tried making a summary. I think Mike8highlighted them and I just kind of want to read9through those again and make sure that we understand10everything you are looking for and to reiterate our11points that can help facilitate that expedition.12One of those areas we've talked a lot13about, RAIs, trying to reduce the number of rounds of14RAIs and even the total number of RAIs, things that15can go that, the quality of your responses,16completeness and the timeliness, we explore different17ways of communicating that to help facilitate that.18Mike has his weekly status calls. We have19talked about -- and on the status calls we can make,20talk further about if we want to set up standing21public meetings. If that can help we can certainly22get those set up as well.23And broader with communication, you know,24those weekly status calls are good opportunities to25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 132identify problems you see coming down the road that1we, both parties can be thinking about and, you know,2maybe it's not something we address immediately, but3at least we can put them on the list of things NRC4needs to think about and things that Northwest needs5to think about, and they can topics of future public6meetings.7We can also talk about, you know, email8communication works, too, send emails. You can update9and propose topics that we can have on those weekly10calls, topics for public meetings, if we can get11those, and it helps, too, we can discuss ahead of time12before we have those calls.13Al touched on this, also that's important14to us is updates to your schedule. This can be15updates as Mike was talking about with responses to16RAIs.17If it's going to take you a little bit18longer to get certain responses to us work that out19with Mike, let us know what's going on with your20schedule so that we can plan and make sure that we21have people available and ready to review your22responses when they come in.23Also, when you plan on submitting24additional applications, primarily your operating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 133license application, helping us have a good idea of1when that's coming in to make sure that we have people2ready to review it when it comes in.3So letting us know delays that might come4up or if your schedule is getting pushed up, it helps5us align our budget and our resources to make sure6that we are ready for your application.7We also talked about pre-application8meetings. So when you are getting ready to submit9your next application for your operating license we10can have meetings ahead of that submission to make11sure that we have a shared understanding of the12information that's coming in that and have discussions13about that so it helps encourage that a quality14submission comes in for your operating license and15could help potentially reduce that review time as16well.17In talking about the operating license18application I wanted emphasize again, because19ultimately we complete this construction permit review20in our 18 to 24-month timeframe, we're still21anticipating an additional 18 to 24-month review for22the operating license application, and I understand23it's critical that we can get that review done24efficiently as well.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 134So I think for those exploring, those pre-1application meetings can be a good way of getting us2started on that review and knowing when it's coming in3can help us be prepared.4We highlighted following the guidance. 5You can gain insight from NUREG-1537, the ISG, our6standard review plan, so you know exactly what the NRC7is looking for when we review the application that you8sent in, also looking at past applications that have9come in to get ideas of questions we have asked in the10past and the level of detail of information that we11found acceptable in the past.12We also talked about reducing13administrative time so that we don't have time that's14spent with people not doing anything, and I think15that's good and I think those weekly calls, again, are16going to be crucial to reducing that administrative17time for processing.18And Mike highlighted again at the end19updating the application as you are responding to20RAIs. That was my list. Were there other things that21I missed that we can --22MR. ADAMS: There's probably one I want to23touch on. I think I touched on it briefly and that's24the operating license application.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 135The last research reactor that we licensed1submitted a complete application at the construction2permit stage so our review was for both the3construction permit and the operating license at the4same time.5Obviously, that has the potential to, you6know, reduce the review time significantly so that's7why we are interested in knowing what's your timing on8your operating license that, you know, that has an9effect because, you know, the theory is that the10construction permit you've given us so much of, say,11you know, your complete design that you've given us so12much of that design and, you know, there is enough13there to make a decision to allow the facility to be14constructed and then the rest of the details on the15design come in with the operating license that, you16know -- so there is a lot of variability what that,17you know, what those parts, you know, what those two18parts look like.19The first part is here, you know, what20needs to come in to fill and, you know, to fill in the21rest of the information and when that information is22coming in I think is important, you know, in the23discussion of, you know, how to change the, you know,24the timing of this and, you know, not only, you know,25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 136talking talk the timing from, you know, the beginning1to you have an operating license.2MR. TIKTINSKY: If I add a little emphasis3from Steve's point on the Part 70 side, you know,4there is many examples of the kinds of the RAIs that5we have asked for Part 70 applications as well as6SERS, so you can sort of see when we write up things7related to 1520 what the kind of things we're looking8for, the kind of questions we had.9And, also, you know, emphasizing of the10use -- You've got multiple things here, the use of11crosswalks, you know, again, the clearer that you can12make it that we understand where the information is13the easier it will be for the reviewers to get the job14done and minimize questions of because we just can't15find information.16MR. FOWLER: So to the list that Steve17summarized very nicely I would add a program/project18management process, just as I manage a program inside19of a private company I have far less insight into the20detailed activities in what's happening at the NRC and21whether we're on track, off track, what are the22constraints, what are the barriers, those kinds of23things.24So a consolidated program project25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 137management structure I think is very, very important1to keep things on track.2MS. HAASS: Yes.3MR. LYNCH: And I think to that, yes, I4think it's very important from both sides to keep each5other updated on where we are at in our reviews and I6think with the calls we can do that.7Also, what we're going to try doing is,8you know, keep you updated on our overall review9schedule. We have this initial review schedule that10we shared here today on our slides, but as things come11up that may necessitate that changing, either12expedited or delays, we need to communicate that to13you as soon as possible, and that's a commitment that14we can make as well.15We are also going to, you'll be seeing16shortly, we're working on developing a public website17that should be going live in the next couple weeks18that you can be able to also have all of your19application data displayed as well, that can be easily20accessed and see our review schedule.21MR. ADAMS: The public --22MS. HAASS: The public would -- Sorry. 23For Northwest Isotopes or for other things as well?24MR. LYNCH: Both. So Northwest specific25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 138and general moly-99.1MS. HAASS: Okay, got it.2MR. ADAMS: And your public information,3not your --4MS. HAASS: I understand.5MR. LYNCH: But, yes, and, you know, as we6continue with the review I'm sure both sides will have7new ideas.8MS. HAASS: Yes.9MR. LYNCH: So chair them and we can10continue to improve.11MR. BALAZIK: All right. At this point12we're a little ahead of schedule. Our senior managers13want to come down for our closing remarks and summary.14The timeframe for that is 2:30, but I15wanted to ask Northwest if they had additional16discussion they want to do in the afternoon on any of17the topics we presented, any topics that we didn't18present today that they would like to discuss in a19public meeting. I've got that scheduled for 1:30 and20lasting about an hour.21MS. GAVRILAS: Yes, I have a suggestion,22that we mull over everything we have heard and perhaps23after lunch we reconvene and that will be the time,24unless you want us to research something over lunch.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 139It's going to be after lunch we reconvene1and we sort of discuss any outstanding items, how's2that?3MS. HAASS: That's fine.4MR. FOWLER: Sounds good.5MR. ADAMS: And another question, is, you6know, giving us information on where you see your7schedule moving forward, you know, especially giving8us the operating license application, is that9something that you are prepared to talk to us today in10this swarm or --11MR. FOWLER: We would certainly be12prepared to respond and provide some answers in a non-13public format, as it's dependent upon a lot of the14questions that were asked of us that are of a15proprietary nature to come up with the anticipated16scheduled.17MR. ADAMS: Okay.18MR. BALAZIK: Okay.19MS. GAVRILAS: Enjoy lunch.20MR. BALAZIK: Yes.21MR. ADAMS: What time --22MS. GAVRILAS: We'll reconvene at --23MR. BALAZIK: Well let's reconvene at 1:3024for discussion of additional topics and then at 2:3025NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 140we'll do the closing remarks.1MS. GAVRILAS: Yes. And we have an2opportunity before the public to --3MR. BALAZIK: Yes, we're going to do that,4too, yes.5MS. GAVRILAS: So we need to stick to the6agenda because --7MS. HAASS: Is there any opportunity for8a non-public portion of this?9MR. BALAZIK: No, there is not.10MS. HAASS: Okay.11MS. GAVRILAS: So we need to stick to the12agenda because the agenda is made available so that13everybody can listen, so we'll just meet back at 1:3014and we'll talk more then.15MS. HAASS: Right.16MR. FOWLER: Very good.17MALE PARTICIPANT: Thank you.18MR. BALAZIK: This is Mike Balazik. We'll19be coming back at 1:30 and we're going on mute until20then.21(Whereupon, the above-entitled matter went22off the record at 11:32 a.m. and resumed at 1:35 p.m.)2324 25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 141A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N1(1:35 p.m.)2MR. BALAZIK: Hi, this is Mike Balazik,3and we want to resume the public meeting with4Northwest Medical Isotopes. Right now in the agenda5we have Northwest Medical Isotope topics. If there's6anything that Northwest wants to discuss with the7staff?8MR. FOWLER: We did not have topics in9public form. We'll arrange a separate non-public10meeting to discuss some topics.11MS. GAVRILAS: Mike, you want to talk12about the setting up closed meetings please, because13apparently there was some miscommunication on what14requirements we must need before we can do that.15MR. BALAZIK: Yes, the requirements for a16closed meeting is to submit an affidavit with the17letter, but with the specific topics that are going to18be discussed in the closed forum.19So then what we would do is we would look20at those topics and agree that yes, these are proper21to be discussed in a closed setting vice an open22public meeting.23So in the affidavit that was provided, I24felt that it was very general, and I received some25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 142advice that it did not contain sufficient detail to1close the meeting.2MS. HAASS: And as discussed with you, we3were, we didn't quite know what would be in the non-4public forum because this discussion had to occur and5that's why it was general. So it's not that we didn't6understand, it was because of how the meeting was set7up.8MS. GAVRILAS: I understand. So the other9thing that we tried to see is if it's okay for us to10close a portion of this meeting. So that was the11homework we did during lunch. And we were advised12that that's not okay because the topics need to be13submitted by affidavit. So we tried.14MS. HAASS: It's a catch 22.15MS. GAVRILAS: Yes.16MS. HAASS: But no, we do understand, you17know, the requirements for a non-public meeting. But18we just didn't have enough data to be able to give you19any more specifics.20MR. LYNCH: That's understood. Well21maybe, if we have some time maybe we could use for22time our over here is to maybe make a list of some23action items that we can take for going forward, and24this could include topics for future meetings that you25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 143might like to have, things you would like to see, and1other things you would like to go forward on both2sides that we can take back and then we can get back3to each other on. Does that sound like something you4would like to go over?5MS. HAASS: I would say we can take some6action items. But just as long as we know it's7subject to change because, you know, I still have some8discussions I need to do.9MR. LYNCH: Understood, understood. Yes,10this is not meant to commit you to anything. This is11intended to help us get an idea of when we leave here12today what should we be most focused on, aside from13reviewing your application.14Mike, did you want to lead with any topics15there?16MR. BALAZIK: One thing we've discussed17before, and again stop me if we're going into18proprietary information. But one thing we've19discussed in the past is facility design, final20design.21And what we've talked about earlier are22our resources for future applications, future23submittals. Is it possible we could get some sort of24idea of how far down that path Northwest is?25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 144MS. HAASS: I think we can state that we1are in the process of finishing our final design. But2from a schedule perspective, that would have to be3discussed in a closed session.4MR. LYNCH: Yes, I think the topic from5that is what, something the NRC is interested in6understanding better from you is when will your final7design be complete, and also how do you think you8might consider submitting that because there are9different ways that the final design can be provided10to the NRC.11The final design can be provided as part12of your operating license application, or you can13amend your current construction permit with additional14design information as you finish it.15And however you choose to do that is fine.16But it does help us to anticipate when that17information might be coming in. So that's just, that18is a topic that would be useful for us to discuss in19the future.20MS. HAASS: Well, and I would be21interested, because this is the closed question, what22have you preferred in the past? Would you like to see23it, like, you know, before the operating license24submission with the, maybe the finalization of the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 145construction permit.1I mean, I don't know. I mean, I don't2know what's the best timing for you guys I guess I3would ask. And then, you know, we'll try and work4that into a schedule.5MR. LYNCH: I think for us, you know,6we're willing to work with you with whichever way you7would prefer. You know, we haven't done something8like this in a very, very long time. So I don't know9if there's a lot of precedent we can necessarily point10to.11But I think we want to work with your12proposal. And by notifying us when it's coming, we13can make sure we have the appropriate resources14available for that.15MR. ADAMS: This is Al. I think, you16know, the understanding of the timing is important17because we're going to, you know, spend time and18effort reviewing what you've given us.19And if we're 85 percent complete with that20review and all of a sudden we have a whole new bunch21of information, it might be advantageous to finish22that 15 percent, take that licensing action and then23try to reset, try to, you know, blend those two24together and start reviewing sort of an expanded25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 146scope.1So you know, part of it depends on the2timing versus if we're only, like, ten percent into3looking at something and the new information comes in,4then the effort or cost of changing your direction,5changing your scope is minimal. So I think that's an6important solution.7MR. LYNCH: Maybe that's a better way to8capture what we can provide that too. We won't advise9you on which way is better than the other. But we can10discuss, as Al was going to, what potential impacts of11your decisions could be.12MR. BALAZIK: This is Mike Balazik. I13guess another potential item is exemptions. I don't14know if Northwest has looked at any potential15exemptions that could come down the road that we could16be aware of or could prepare for, just kind of another17item that would benefit us in future reviews on18exemptions.19MS. HAASS: Okay.20MR. LYNCH: And even more broadly, just21other licensing actions in addition to your primary22construction permit or operating license, or material23license and application that we might need to consider24and the timing. And for example, that could include25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 147the other research reactors that might be seeking1amendments to support that, knowing the timings that2those licensing actions can help us as well.3MR. ADAMS: Another example would be if4there's any need for shipping packages that would be5unique to what you're doing that, you know, don't6exist. That's another part of NRC and that's, you7know, a discussion that they have their own timelines8for doing that type of work.9MS. HAASS: And we've had brief10conversations with the other organizations, too.11MS. YOUNG: And that's under Part 71.12MR. LYNCH: Another topic that, you know,13that I think we could discuss going forward to our,14we've touched on the topic of potentially setting up15standing public meetings.16Put that on the list of establishing if17that's something that you want to pursue, what you18think appropriate frequency for those meetings might19be, what topics you might want to discuss during20those. I think that, I took that as one of the take-21always I had from earlier today as a topic we should22explore further.23MR. BALAZIK: I guess, this is Mike24Balazik again, for expectations for interactions with25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 148the NRC for the environmental review, we're pretty1much had a set process. I mean, is there any2recommendations on communications that you would like3to see in the future?4MS. HAASS: Just want to make sure that5the RAIs get reviewed prior to going out final to make6sure there's no business sensitive information in7there. If you can at all let me know the possible8timing when that's going to come in, you know, we have9a lot of things going on as well and I need to make10sure our resources are there.11And I know when we get into the safety12aspect it can get more and more difficult, you know,13to get those reviewed, and what resources that means14to us as well.15Also from, Nancy, from your perspective,16I mean, you'll have another public-type meeting within17the NEPA realm. And you know when you're going to be18scheduling that. I know that the City of Columbia was19asking me that question as well.20I just know, you know, they told me they21would really like to help you do that. And I know22last time you guys went and did that, you know,23independently which is fine, but they're also willing24to go help as well. And, you know, you have their25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 149contact information now.1MS. YOUNG: Okay, thank you.2MR. LYNCH: Were there any topics that3you've had in mind in addition to that that you would4like to focus on in the future?5MS. HAASS: No. I think when you start6looking at schedule, the other licensing actions and7the same in the public meetings, that's really where8we want to focus with you guys.9Obviously, the standing public meetings,10you know, we'll assume that there will be some closed11portions of those meetings within that, you know, with12the appropriate documentation, understand that.13MS. GAVRILAS: Mike, you'll need to14elaborate on the process. I think we need the15affidavit with sufficient detail --16(Simultaneous speaking)17MS. HAASS: Oh, that's what I just said.18Right, no --19MS. GAVRILAS: So that's --20MS. HAASS: I said with the appropriate21documentation there would be closed portions as well22because there are certain things that, you know, that23are technically sensitive as well.24MS. GAVRILAS: Sure.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 150MS. HAASS: And so any time we have a1topic, assume that there's going to be some, there's2most likely going to be something business sensitive3in there if it has anything to do with some details of4the facility.5MR. TIKTINSKY: You don't want to forget,6Dave Tiktinsky, the security related information7aspects of public meetings with technical discussions8which is different because that's a different part of9the regulations.10MS. GAVRILAS: Definitely.11MR. TIKTINSKY: So that's always something12we want to make sure that, you know, why we close13meetings related to discussions of that and14information that's the integrated safety analysis or15things that are preferably security related.16MR. BALAZIK: Anybody have anything else?17MS. GAVRILAS: Open it to the public I18would say.19MR. BALAZIK: All right, we can open up to20the public. Actually, I do have one more item. 21Karen, you mentioned resources. Is there the22potential for any impact in the future for Northwest23resources for the review of this application, or even24future applications? There would be no change or any25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 151fluctuations that could potentially happen?1MS. HAASS: Well, there's no change in our2primary subcontractors, no.3MR. BALAZIK: Okay.4MS. HAASS: And they have the people to5support this. But, you know, you still have to6schedule it.7MR. BALAZIK: Yes, no. I understand, I8understand.9MS. HAASS: So yes, but that is not going10to change.11MR. LYNCH: I guess maybe just as a12closing question, do you feel like your expectations13were met today? Did we accomplish what you wanted to14accomplish at this meeting, or at least start moving15in the right direction?16MR. FOWLER: So we had two objectives as17we introduced this meeting from a Northwest Medical18Isotopes perspective. The first was gaining alignment19around or understanding in common of the licensing20application process.21And that one we've I think beaten to death22and are in violent agreement now with an understanding23from both NRC and from Northwest Medical Isotopes of24the options. And the follow up next step on that is25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 152to telegraph to the NRC our intentions. And so I1think from a first objective standpoint, we can2declare success on that one.3The second, and frankly more important one4to the nation and to public health and to public5safety is the speed with which we can accomplish a6successful review within the guidelines and7regulations.8I think this is, we did not have an9expectation that that would be solved in this meeting10today. Our expectation was that we would have a plan11to get to a plan.12What we accomplished in my view today is13I've received more granularity in the schedule14elements from the NRC and the assumptions behind the15schedules, how many iterations of RAIs, how many16iterations for the RCS and so forth.17So I think we now have a framework with18which we can succeed in a productive conversation on19translating the list, Steve, that you've so well-20articulated and added to and convert that into an21operating plan.22And ultimately, what it comes down to to23a company like ours is predictability. Sufficient24granularity in schedules so we know what's next, how25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 153do we assess that each one of those milestones whether1it's on track or off track, and our ability to predict2those next steps, manage accountability, manage3schedule, manage budgets.4The risk to any business, the biggest risk5to any business is uncertainty. And we've been in an6uncertain environment. And this meeting succeeded in7helping to remove some of the uncertainty in terms of8establishing a framework where we can now discuss the9schedule.10And a number of the elements are going to11obviously fall right back on us. We have better12expectations of what the standard is by which we need13to meet. But I think we also can establish a program14management plan so we collectively understand when a15milestone's been achieved and what the next milestone16that we all need to focus on.17MR. BALAZIK: And if there are no more,18this is Mike Balazik, again. If there are no more19questions in the room, first of all I guess I would20like to ask if there's any NRC staff on the phone that21has any questions. And then we'll open it up to the22public.23(No audible response)24MR. BALAZIK: Okay, hearing no questions25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 154from the NRC staff, so now I would like to open up the1phone lines to the public for public comment. Just a2couple of items.3Please, speak one at a time and identify4yourself in speaking. And also if you're5uncomfortable asking a question on the phone, you can6submit your question to me via email at mfb@nrc.gov.7Are there any public comments?8(No audible response)9MR. ADAMS: Can someone verify that the10phones are still open and working?11PARTICIPANT: Yes, the phones are open.12MR. ADAMS: All right, we just want to13make sure silence wasn't something unplugged14somewhere.15MR. LYNCH: Thanks, Jenny.16PARTICIPANT: We're here, thank you.17MR. BALAZIK: All right. So I think we18are, are we expecting Bill and others to join us19later?20MS. GAVRILAS: Yes. I think we'll adjourn21until 2:30 when we have an opportunity to interact22with two office directors. I think at least one23office director, perhaps two. And certainly my boss,24Lawrence Kokajko is going to join us.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 155I don't know if Craig who is the acting1director in Shana's organization is also going to join2us. So you'll have an opportunity to reiterate, we'll3reiterate our action items and you'll have an4opportunity to interact with them.5MS. HAASS: And which office directors,6potentially?7MS. HELTON: Bill Dean.8MS. GAVRILAS: Bill Dean, our director is9coming for sure.10MS. HAASS: Okay.11MS. GAVRILAS: And his deputy might come12as well.13MR. ADAMS: So we're going to go mute on14the phones until 2:30 and then we'll be back on.15(Whereupon, the above-entitled matter went16off the record at 1:54 p.m. and resumed at 2:33 p.m.)17MR. BALAZIK: Mike Balazik, we're resuming18the public meeting. Right now we're toward the end of19the meeting. And we just want to real quickly go20through some closing remarks. Oh, I'm sorry.21Bill Dean, Office Director of NRR is22joining us, and Michele Evans has also joined us, and23Lawrence Kokajko has also joined is. He's the24Director of DPR, for our members on the phone. All25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 156right.1(Off microphone comments)2MR. BALAZIK: Okay, can we just go through3everybody, identify themself that's new to the4meeting?5(Simultaneous speaking)6MS. EVANS: Sure. Michele Evans, Deputy7Director of NRR.8MR. KOKAJKO: Lawrence Kokajko, Division9Director, Division of Policy and Rulemaking.10MS. MARSHALL: Jane Marshall, Deputy11Director, Division of License Renewal, NRR.12MR. ERLANGER: Craig Erlanger, Acting13Director for the Division of Fuel Cycle Safety14Safeguards and Environmental Review.15(Off microphone comments)16MR. BALAZIK: Okay. You want to start?17MS. GAVRILAS: Yes, so we had what I would18qualify as a productive meeting this morning. And I'm19going to ask the Northwest Medical Isotopes to bring20their own clarification.21Mike and Steve prepared a few summary22points of the meeting that I'll ask them to go23through, a couple of action items. And then I know24that Bill would like to engage you in some25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 to1summarize.2MR. BALAZIK: You going to go through the3points, Steve? You have the points?4MR. LYNCH: Whatever you would like.5MR. BALAZIK: Yes.6MR. LYNCH: I can go through it.7MS. GAVRILAS: One of you two needs to do8the summary of this morning, please, and the action9items. Thank you very much.10MR. LYNCH: All right. So I guess for11everyone's benefit that's in here that was not here in12the morning, we had two main objectives that we had13set out to accomplish as identified by Northwest, and14those were to talk about the licensing approach for15the facility. And then the second item was to talk16about mechanisms to expedite the review of Northwest's17construction permit application.18For the first point, we reached agreement19and a shared understanding that there is additional20technical information that Northwest will need to21provide to meet the Part 70 requirements in 10 CFR.22Whether that's submitted as part of their23operating license or as a separate application is up24to them, but we are in agreement that regardless of25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 158how the information is packaged, we understand on both1sides what technical information needs to be provided.2Is that correct?3And then the second point for mechanisms4to expedite the review, we went over a number of items5that we can do on both sides to make sure that we6review their construction permit application as7expeditiously as possible.8One of the items we discussed were9approaches to request for additional information to10limit both the total number of RAIs that we asked and11the number of rounds that we go through.12Ways that we can address that are ensuring13that the NRC is clear in the questions that we ask and14making sure that we have phone calls with Northwest15when those RAIs are issued to make sure they16understand the question that we are asking.17And also when they are getting prepared to18submit their responses, to have additional calls. 19That may take the form of a public meeting if we need20to discuss technical details, or it could be shorter21clarification calls to make sure that they're on the22right track.23Again, the goal of that is to make sure24that we have a shared understanding of the NRC's25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 159expectations and what Northwest's understanding of our1expectations is. We also emphasize that quality and2completion of those RAIs is important as well.3This fed into a larger discussion of4appropriate methods of communication during the review5process. We have already established weekly calls6following the docketing of the application that Mike7and others as needed sit on with Carolyn once a week8to discuss the status of the review and then the other9administrative details as necessary. And that's10consistent with our practices for other reviews11throughout the agency.12MR. DEAN: So how long has that been going13on? For how long?14MR. LYNCH: Since January 12th.15MR. DEAN: Okay, all right.16MR. LYNCH: So right after we concepted17the review and everyone got back from the holidays.18MR. DEAN: Okay.19MR. LYNCH: We discussed the importance of20staying up to date on schedule, both from the NRC's21perspective as we're doing our review to make sure we22communicate how we're progressing towards milestones,23and also to get updates from Northwest on24anticipations of when, you know, if they have any25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 160delays on the current application, responses through1RAIs, and just updates of when they anticipate2submitting future applications such as their operating3license application.4We discussed, as far as the information at5Northwest provides what's the threshold of what's6acceptable to the NRC, we went there already following7our formatting content that I had provided in NUREG81537 and the ISG augmenting NUREG 1537.9And as far as the threshold that we set10for the information that we're doing our review, we11told them that when we do our review we use our12standard review plan that is publically available, and13that is the threshold we set for the information that14we are looking for in their application.15And to maximize the efficiency of our16review, the clearer it is to us that they have17addressed the acceptance criteria in the standard18review plan, the easier it is for the NRC to move19forward quickly.20MR. DEAN: Both for the Part 50 and the21Part 70 aspects?22MR. LYNCH: Yes, yes. We discussed the23guidance for both aspects that they can use.24MR. DEAN: Okay.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 161MR. LYNCH: We also talked about the1importance of reducing administrative time for2processing on the NRC side and also preparation of3documents on Northwest's side. The goal is through4our talks to make sure that there isn't significant5debt time where either side is sitting, not doing6anything and just waiting.7And this feeds into general program and8project management on both sides and making sure that9we are identifying clear goals towards working towards10the identified milestones that we have in the project.11And the last thing that we went over, or12I shouldn't say last thing, I could think of two more13things. Looking at past precedents, we have examples14of reviews we have done in the past, most recently15with SHINE, there are transcripts available from ACRS16meetings that they can look through as we go through17ACRS to help improve their preparation for those18meetings.19Also, they can get a sense from looking at20these applications for what the NRC has found21acceptable in the past and types of RAIs we've asked22in the past and what types of responses we're looking23for and similarity of reviews.24As we get ready for their operating25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 162license application, one way we can get ready for that1is we explore the possibility of having pre-2application meetings to discuss the technical problems3or issues that may come up that we need to explore4before the application is submitted that there may be5questions on.6And also with the current construction7permit application, we talked about efficiencies that8can be gained from maintaining that document up to9date as they respond to RAIs and information in their10current PSAR needs to be updated, that they can11provide updates to that.12At times it will work out with Mike, it13will make it easier for our reviewers to have a single14document to look at that has all of the updated and15completed information, and also as we go forward to16the ACRS and with the mandatory hearing.17We also discussed earlier today the status18of our review and our plans going forward. So with19all of that, I think with that I think with those20topics, that addressed the second main point of21talking about ways that we could expedite the review. 22I think that covers it for that second point.23MR. FOWLER: You did a good job, thank24you.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 163MR. LYNCH: And then between 1:30 and 2:001we came up with a list of action items to take away to2come back to in the future. The first of these was3setting up a, exploring the possibility of setting up4standing public meetings.5And this, Mike and Northwest will work6together on this to see if it's needed. But the idea7behind this is to cut down on some of that8administrative time.9If we see the need to discuss significant10technical information, most likely related to RAIs on11a regular basis, instead of noticing public meetings12every time we need to have one, we set up a frequency13maybe once a month, once every other month, something14that's agreed upon between both parties. That was15identified as a topic worth exploring in the future to16see if it could help in the review.17The next action item we had was in a18future meeting discuss when the final design for19Northwest will be provided to the NRC. This includes,20you know, the final design could be submitted as part21of the operating license application, or it could be22submitted while we are still reviewing the23construction permit.24And understanding Northwest's intent will25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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 of1that, we can discuss with them in the future the2impact of their decision to go forward one way or3another, without recommending a preference.4The third item that I had here was the NRC5could benefit also from understanding any additional6licensing actions that Northwest may request in the7future.8This could be related to transportation of9materials, any exemptions that they foresee needing10for their current licensing requests or future11licensing requests. Also, license amendments that12existing research reactors might need in order to13support the radiations of their manufacture targets.14Fourth item that we had as a take-away was15making sure that we have clear expectations on both16sides. This has to do with, mostly with requests for17additional information.18Northwest would like to be able to review19drafts of the RAIs for potential proprietary20information before they're issued. And also to the21extent practicable, we would like notifications of22when the RAIs are getting close to being issued so23that they can make sure that their resources are ready24to receive any begin working on responses to them.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 165Also, Northwest offered that for future1public meetings, that we have it out in Missouri, that2the local government there is willing to work with us3in getting that set up in the future as well.4And I think the last thing, the last5action item I had on here was on both sides, and it's6kind of relates to everything else we've just been7talking about is just having clear communications on8both sides of schedule, NRC making sure that we9identify the milestones that we're working towards and10our progress towards that and Northwest, again letting11us know their schedule and any impacts they may have.12MR. DEAN: Okay, is that it?13MR. LYNCH: Yes.14MR. DEAN: Okay. Good. Sounds like you15guys had a productive meeting. So appreciate you guys16coming here from Oregon? Both of you from Oregon?17MS. HAASS: The northwest.18MR. DEAN: Northwest? Okay. Go Ducks. 19No?20MR. FOWLER: Well, we have Ducks and21Beavers.22MR. DEAN: Okay, all right. Depends what23part.24MS. HAASS: I'm a Husky.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 166MR. DEAN: Okay, depends on what part of1the state that you're from. Well, so I appreciate you2guys coming in. And it sounds like it was very3productive and useful meeting.4I know that you all were here not too long5ago and had expressed some concerns with some of our6commissioners and some of our senior management about7the process and not having a good understanding of the8process.9And so it sounds like, and I certainly10would be interested in your all's perspective that11today's meeting helped move us forward in terms of12establishing better communication and better13understanding of what you can expect from us, but also14things that we hope that we can engender from your15side of it because I view, personally I view this16process, and it's a big deal right, moly-99 is a big17deal for this country.18And so you guys are pursuing something19that is important to public health and safety which is20obviously the ultimate mission or objective of the21NRC, that we do it in a collaborative way and not in22any sort of adversarial way.23I know there's always just sort of dynamic24in terms of a licensee or an applicant and the NRC and25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 167we ask a bunch of questions, you got to give us a1bunch of answers.2But in reality, I think we're all striving3to get to the same point which is can we get licensed4for construction and utilization a facility that can5be useful in providing moly-99.6So in that regard, I think what we have is7a very common end point. So I guess I would be8interested in your all's perspective in terms of how9you thought today's discussion went, were we able to10address perhaps some of the concerns you've had in the11past.12And if there's still some open questions,13you know, Steve went through a list of action items,14but are there still some things that you all have in15your mind that are kind of open or areas that we ought16to consider.17Like, one thing I didn't hear in your18discussion was the benefit of, you know, sometimes19when we get an RAI process there's this kind of20throwing stuff over the transom and then you all21develop and throw it back over the transom.22And sometimes we can make better progress23if we do things like, well we call them audits, right,24but we actually either send people to wherever the25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 168information is and have face to face meetings as1opposed to going into a sort of a writing campaign. 2Is that something you guys talked about was the audit3process?4MR. LYNCH: We did not talk about that5today. But we have had an audit on the environmental6side as they were preparing information.7MR. DEAN: Okay.8MR. LYNCH: So we have gone through that.9MS. HAASS: And we've had the discussions10in the past and we know that it's one of the tools we11can use to make things more efficient.12MR. DEAN: Okay. Okay, good. Okay, and13then the other one was I didn't hear anything about14would it be beneficial for example to set up an15electronic reading room where you guys have materials16that you developed that are accessible to our staff17through some sort of portal or whatever so there's18more ready actions instead of you guys having to mail19them.20MS. HAASS: Well, and we are setting that21up. There's always technical difficulties because you22guys have some requirements and you know what they23are, you know, about the encryption and the passwords24and this, that, and the other. And so those things25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 169are getting set up.1MR. DEAN: Okay. I think we've had some2success where the licensee sort of maintains that and3then we just get a password for access and it helps4maybe avoid some of those, you know, red tape things5that we tend to have as a bureaucracy.6But anyway, so we certainly, that would be7something that could hopefully improve or increase8efficiency.9MS. HAASS: Well, and another thing that10could help efficiencies is I know we talked about it11a bit offline just standing here. But, you know, some12granularity on how, what RAIs are going to be coming13because you're not going to throw all of them over at14once.15You may be doing them based on subject16matter areas and, you know, getting a better17granularity in a schedule like that because that helps18both your resources and ours and us to be more19efficient in responding as well.20MR. DEAN: So I was pleased to hear that21you guys have set up weekly calls. So hopefully22you're finding those beneficial. I know that we do in23terms of being able to ferret out those sort of24things.25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 170And I don't know whether, have you guys1kind of developed sort of a standing agenda, or has it2kind of been sort of ad hoc? I would assume that3there's things that week to week that you're going to4want to talk about.5MS. HAASS: Yes, there's definitely a6standing agenda. But then, you know, you've got7things come on and off that agenda as well.8MR. BALAZIK: And this is Mike Balazik. 9And sometimes we'll share stuff earlier in the week10that is to be a great topic to have on that weekly11call so that we can take one level deeper into it if12it's just Kevin and I talking. Sometimes we'll move13stuff on a weekly call.14MR. DEAN: And also to make sure we get15the right people there.16MR. BALAZIK: Correct.17MR. DEAN: Okay, all right. So that's18good. I think that's a great initiative to do that.19So at least what I'm hearing was that it was a20constructive, worthwhile meeting, is that --21MR. FOWLER: I do believe it was a very22productive meeting. And for those of you who attended23our meeting about a month ago in the Executive24Director's office, we understand that the NRC has a25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 171mission for public health and takes the production1capability this country for moly-99 very seriously.2We understand that, appreciate that,3respect that. I hope that you all also understand4that we take our mission of providing that secure,5reliable supply of moly-99 in the United States6extremely seriously. That was part of the intent with7the Executive Director's office when we were there.8We also wanted to communicate that while9we all know that this is a public health potential10issue, sometimes hearing directly from the feet on the11street, the constituents and our supporters and12investors are public healthcare institutions serving13tens of millions of people across the United States.14And so to hear directly from the CEOs of15those public health services organizations I think is16important to remind us of just how real the mission17that we share collaboratively really is. It's18extremely important.19This meeting stemmed as a follow up to a20couple of outstanding items from the initial meeting,21the first being clarification on our licensing22application submission process. And that one, declare23victory.24We understand it is in good shape. We25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 172all, I think, are in agreement that we understand1where to go from here. We will need to telegraph our2approach so that the NRC can anticipate. But we're3all on common understanding of that first objective. 4So declare success on that one.5The much broader one is how do we meet the6needs of this country in a timely fashion. And what7we achieved today was establishment of a very strong8framework that we now understand better how the9schedule of review is constructed and built within the10NRC.11That helps tremendously because we can12look at the assumptions, we can compare the13assumptions, and we can begin to manage this as a14project. It's likely, in fact it's assured, that15we'll need a number of follow up conversations to16translate that framework into a plan that can be17project managed, and we've left with a joint objective18to do exactly that.19And Steve did a great job of summarizing20some of those actions. And so we can't yet close with21full success the second objective on accelerate the22schedule to degree possible.23I think we have a pathway to continue a24process to get to a mutually agreed schedule, one that25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 173we can both bring back to our supporters and manage1against with expectations, identify milestones,2identify where we've deviated from milestones, and3take remedial actions as appropriate.4And that, to me, is a successful day spent5here in the DC area.6MR. DEAN: Well good, I'm pleased to hear7that, Nick, in terms of your perspective on how the8meeting went because certainly this was one that I9felt was very important, you know, the fact that10Michele and I and Lawrence wanted to make sure that we11touched base with you all before you left to make sure12that the meeting met your objective was very important13to us.14And so that gives me great confidence that15we did have a constructive and productive dialogue. 16But we need to sustain that.17MR. FOWLER: Exactly right.18MR. DEAN: And I like some of the things19you guys have talked about in terms of potential20action items. I was interested a little bit more in21exploring the topic that Steve raised that when we22have meetings in Missouri and the engagement of the23local government.24What's the sort of the rationale, what are25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 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,1but I mean --2MR. FOWLER: That was in specific3reference to any ongoing environmental public meeting4needs where we've had one meeting in Columbia already.5If there were needs for others, the City of Columbia6and the County of Boone County in Missouri have7offered any and all assistance to the NRC if any is8requested.9MR. DEAN: Okay.10MR. FOWLER: They stand ready to help.11MR. DEAN: Okay.12MR. LYNCH: And this is consistent with13previous reviews, even for the SHINE review we've gone14out for the environmental meetings generally, send an15email to the city manager and county executives, let16them know we're coming, offer any government-17government interaction they would like to better18understand our process and work our way forward.19MR. DEAN: Okay.20MR. LYNCH: So that's all consistent.21MR. DEAN: Okay. Good, okay. Good.22MS. HAASS: And there's also the ability23that they would help you coordinate to make things24easier, you know, on you. They have the facilities25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 175available.1MR. DEAN: That's great.2MS. HAASS: And so, and they want to be3involved.4MR. DEAN: Super. Okay, that's wonderful.5Okay, good. Okay. Anything for me that you would6like to convey beyond what you already have?7MR. FOWLER: Well I think that again,8we've had a successful meeting. I think in other9strategic partnerships that are collaborative in10business that I run, we have not only program11management at the level of checking all the boxes on12the program plan, we have a refreshment at this level13to ensure that both parties are in fact comfortable14with progress and resource assignments and strategic15alignment as we move forward.16Certainly it doesn't need to be a monthly17meeting at this level, but probably on a quarterly or18semi-annual basis it would make sense for us to touch19base at this level to ensure that we're both meeting20each other's expectations of moving forward.21MR. DEAN: Okay. And you're comfortable22with the 12 to 15 to 1 ratio of members of the NRC? 23Is that okay? You're comfortable with that ratio?24MR. FOWLER: Well, come out our way and25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433 176we'll reverse the ratio.1MR. DEAN: Good, good. Well, anything2else that you would like to achieve today?3MS. GAVRILAS: No. I think we met their4objectives and we have a good meeting.5MR. DEAN: Okay, good. Good. All right,6so who do I point to in terms of is it Mike is the7sort of individual that I want to point to as8somebody, for SHINE I went to Steve a lot. So is9Mike?10MS. GAVRILAS: So that was one of the11issues we discussed that even though there are12multiple organizations involved in the review, there13will be one voice for the NRC and that voice is Mike.14MR. DEAN: Okay, good. Okay, good. 15Super. Okay, anything else? Excellent. Okay.16MR. FOWLER: Finished the agenda on time.17MR. DEAN: Safe travels. Safe travels18back.19MR. BALAZIK: This is Mike Balazik. I20just want to thank everybody for attending the meeting21today. And we're going to close the bridge line. 22Thank you.23(Whereupon, the meeting in the above-24entitled matter was concluded at 2:58 p.m.)25NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.(202) 234-4433WASHINGTON, D.C. 20005-3701(202) 234-4433