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{{#Wiki_filter:UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of SHINE MEDICAL TECHNOLOGIES, INC.                                      Docket No. 50-608-CP (Medical Radioisotope Production Facility)
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ORDER (Setting Deadline for Proposed Transcript Corrections)
The Commission held an evidentiary hearing on December 15, 2015, at its Rockville, Maryland headquarters to receive testimony and exhibits in this uncontested proceeding. The hearing transcript is appended to this Order. Pursuant to my authority under 10 C.F.R.
§ 2.346(a) and (j), the parties may file any proposed transcript corrections no later than December 28, 2015. The parties may coordinate their responses and file a joint set of corrections.
IT IS SO ORDERED.
For the Commission NRC SEAL
                                                      /RA/
Annette L. Vietti-Cook Secretary of the Commission Dated at Rockville, Maryland, this 21st day of December, 2015.
 
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
 
==Title:==
Hearing on Construction Permit for Shine Medical Isotope Production Facility Docket Number:    (n/a)
Location:        Rockville, Maryland Date:            Tuesday, December 15, 2015 Work Order No.:  NRC-2982                          Pages 1-222 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
 
1 1                    UNITED STATES OF AMERICA 2                NUCLEAR REGULATORY COMMISSION 3                                + + + + +
4    HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL 5                  ISOTOPE PRODUCTION FACILITY:
6    SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING 7                                + + + + +
8                          PUBLIC MEETING 9                                + + + + +
10                                TUESDAY 11                        DECEMBER 15, 2015 12                                + + + + +
13                      ROCKVILLE, MARYLAND 14                                + + + + +
15                  The Commission met in the Commissioners' 16 Conference Room at the Nuclear Regulatory Commission, 17 One White Flint North, 11555 Rockville Pike, at 9:00 18 a.m., Stephen G. Burns, Chairman, presiding.
19 COMMISSION MEMBERS:
20            STEPHEN G. BURNS, Chairman 21            JEFF BARAN 22            WILLIAM C. OSTENDORFF 23            KRISTINE L. SVINICKI 24 ALSO PRESENT:
25            ANNETTE L. VIETTI-COOK, SECY NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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2 1 NRC STAFF PRESENT:
2            ALEXANDER ADAMS, JR., NRR 3            MARY ADAMS, NMSS 4            MARISSA BAILEY, NMSS 5            GREGORY CHAPMAN, NMSS 6            WILLIAM DEAN, NRR 7            MARGARET M. DOANE, OGC 8            MIRELA GAVRILAS, NRR 9            CATHERINE KANATAS, OGC 10            STEVEN LYNCH, NRR 11            JANE MARSHALL, NRR 12            KEVIN MORRISSEY, NMSS 13            MICHELLE MOSER, NRR 14            JOSEPH STAUDENMEIER, RES 15            CHRISTOPHER TRIPP, NMSS 16            CARL WEBER, NRO 17            DAVID WRONA, NRR 18            MITZI YOUNG, OGC 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 1 APPLICANT AND WITNESSES PRESENT:
2            STEPHEN BURDICK, Morgan Lewis & Bockius 3            RICHARD VANN BYNUM, SHINE Medical Technologies 4            JIM COSTEDIO, SHINE Medical Technologies 5            BILL HENNESY, SHINE Medical Technologies 6            CHRISTOPHER HEYSEL, Information Systems 7                  Laboratories 8            ALAN HULL, Golder Associates, Inc.
9            CATHERINE KOLB, SHINE Medical Technologies 10            TIMOTHY KRAUSE, Sargent & Lundy 11            STEPHEN MARSCHKE, Sanford Cohen and Associates 12            GREG PIEFER, SHINE Medical Technologies 13            KATRINA PITAS, SHINE Medical Technologies 14            ERIC VAN ABEL, SHINE Medical Technologies 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 1                              A G E N D A 2 Overview (SHINE Medical Technologies, 3      Inc.)    . . . . . . . . . . . . . . . . . . . . 14 4 Commission Q & A        . . . . . . . . . . . . . . . . 36 5 Overview (NRC Staff)          . . . . . . . . . . . . . . 55 6 Commission Q & A        . . . . . . . . . . . . . . . . 73 7 Break . . . . . . . . . . . . . . . . . . . . .                      101 8 Safety - Panel 1        . . . . . . . . . . . . . . .              101 9 Commission Q & A        . . . . . . . . . . . . . . .              114 10 Break . . . . . . . . . . . . . . . . . . . . .                      135 11 Safety - Panel 2        . . . . . . . . . . . . . . .              136 12 Commission Q & A        . . . . . . . . . . . . . . .              148 13 Environmental - Panel . . . . . . . . . . . . .                      164 14 Commission Q & A        . . . . . . . . . . . . . . .              191 15 Break . . . . . . . . . . . . . . . . . . . . .                      210 16 Closing Statement by Applicant                  . . . . . . . .      210 17 Closing Statement by Staff              . . . . . . . . . .          215 18 Commission Q & A and Closing Statements . . . .                      217 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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5 1                      P R O C E E D I N G S 2                                                            9:01 a.m.
3                  CHAIRMAN BURNS: I call this hearing to 4 order on a more serious event, but first let me get my 5 script out as we do need to go through a number of 6 things before we begin this hearing.
7                  I want to welcome the audience and those 8 who may be viewing this remotely on line. Welcome to 9 the Applicant, to the Staff, members of the public.
10 And      the  Commission      is    here    today    to conduct      an 11 Evidentiary Hearing on the SHINE Medical Technologies 12 application for a construction permit for a medical 13 radioisotope        production        facility      in  Janesville, 14 Wisconsin.
15                  This hearing is required under Section 16 189A of the Atomic Energy Act of 1954, as amended. And 17 the Commission will also be reviewing the adequacy of 18 the NRC Staff's Environmental Impact Analysis under 19 the National Environmental Policy Act of 1969, which 20 many of us refer to as NEPA.
21                  This is the third so called mandatory or 22 uncontested hearing that the Commission has held this 23 year, but unlike the two previous ones, this one is 24 for a construction permit, not for a Combined License.
25 But the requirements for the necessity of a hearing on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 1 a construction permit is required as I noted under 2 Section 189A.
3                  During the hearing, SHINE and the Staff 4 will provide testimony and witness panels that will 5 provide an overview of the application, as well as 6 address safety and environmental issues associated 7 with the review, and Commission questions will follow 8 each panel. And there will be a rotation of the 9 Commissioners        from      panel      to      panel,  and        the 10 Commissioners may allocate their total time among the 11 panels as each Commissioner sees fit.
12                  In order to issue a construction permit 13 the Commission must make certain specific safety and 14 environmental        findings.        On    the    safety  side,      the 15 Commission will determine whether in accordance with 16 10 CFR 50.35(a), whether the Applicant has described 17 the proposed design of the facility, including the 18 principal architectural and engineering criteria for 19 the design, and whether the Applicant has identified 20 the major features or components incorporated therein 21 for the protection of the health and safety of the 22 public.        Also,  such    further      technical      or    design 23 information as may be required to complete the safety 24 analysis, and those which can be reasonably left for 25 later consideration to be supplied in the Final Safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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7 1 Analysis          Report;      whether        safety        features        or 2 components,          if  any,    that      require        research      and 3 development have been described by the Applicant, and 4 the      Applicant      has    identified,        and    there  will        be 5 conducted          a    research      and      development        program 6 reasonably designed to resolve any safety questions 7 associated        with  such    features        or  components;        and 8 whether        on  the  basis    of    the      foregoing    there        is 9 reasonable assurance that, one, such safety questions 10 will be satisfactorily resolved at or before the 11 latest date stated in the application for completion 12 of the construction of the proposed facility; and, 13 two,      taking    into  consideration          the    site  criteria 14 contained in 10 CFR Part 100, the proposed facility 15 can      be    constructed      and    operated        at  the  proposed 16 location without undue risk to the health and safety 17 of the public.
18                    In making these findings, the Commission 19 will also be guided by the considerations in 10 CFR 20 Section 50.40 which include the Commission's opinion 21 as to whether the issuance of the construction permit 22 will not be inimical to this common defense and 23 security or to the health and safety of the public.
24                    With respect to environmental matters, the 25 Commission will determine whether the requirements of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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8 1 NEPA        Sections  102.2(a),        (c)      and    (e),    and      the 2 applicable regulations in 10 CFR Part 51 have been 3 met. The Commission will independently consider the 4 final balance among conflicting factors contained in 5 the      record  of  the      proceeding          with    a  view        to 6 determining        the  appropriate        action        to  be    taken, 7 determine after weighing the environmental, economic, 8 technical, and other benefits against environmental 9 and        other    costs,      and      considering          reasonable 10 alternatives whether the construction permit should be 11 issued,        denied,    or    appropriately          conditioned          to 12 protect environmental values, and determine whether 13 the NEPA review conducted by the Staff has been 14 adequate.
15                  This meeting is open to the public, and we 16 do not anticipate the need to close the meeting to 17 discuss        non-public      information,          but    if  a    party 18 believes that a response to a question may require a 19 reference to non-public information, then I would ask 20 the party to answer the question to the best of its 21 ability and practicality with information that is on 22 the public record, and file any non-public response 23 promptly after the hearing on the non-public docket.
24                  Before      proceeding,            do    my      fellow 25 Commissioners have anything they'd like to add? Then NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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9 1 we'll proceed with the swearing in of witness. We'll 2 start first with SHINE. I'd ask counsel for SHINE to 3 introduce himself.
4                  MR. BURDICK: Good morning. This is Stephen 5 Burdick from Morgan Lewis & Bockius, also joined by my 6 colleague, Paul Bessette. We are counsel for SHINE.
7                  CHAIRMAN BURNS: Okay. Counsel, would you 8 read the names of the witnesses?
9                  MR. BURDICK: Yes, and if the witness would 10 please stand when I read their name, and then remain 11 standing until the Chairman directs otherwise.
12                  In alphabetical order SHINE's witnesses 13 are Joseph M. Aldieri, Jeffrey M. Bartelme, Richard 14 Van Bynum, James Costedio, William Hennesy, Alan Hull, 15 Catherine Kolb, Timothy P. Krause, Thomas Krzewinski, 16 C. Michael Launi, James W. McIntyre, John B. McLean, 17 William D. Newmyer, Greg Piefer, Katrina M. Pitas, 18 Erwin T. Prater, Louis Restrepo, Eric N. Van Abel, 19 George        F. Vandegrift,      Tamela      B. Wheeler,    Ernest 20 Wright, and Steven L. Zander. Thank you.
21                  CHAIRMAN BURNS: Okay, thank you.
22                  Witnesses, I'd ask you to raise your right 23 hand to take the oath.
24                  Do you swear or affirm that the testimony 25 you will provide in this proceeding is the truth, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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10 1 whole truth, and nothing but the truth?
2                ALL WITNESSES: I do.
3                CHAIRMAN BURNS: Did anyone fail to take 4 the oath? Indicate so, otherwise. No. Thank you. You 5 may be seated.
6                Is there any objection to including the 7 witness list into the record?
8                MS. KANATAS: No objections.
9                CHAIRMAN BURNS: Okay, thank you, counsel.
10                And then with respect to -- we'll proceed 11 in terms of the admission of evidence on behalf of the 12 Applicant. Are there any edits to your exhibit list, 13 counsel?
14                MR. BURDICK: There are no edits.
15                CHAIRMAN BURNS: Okay. Would you read the 16 range of numbers of the exhibits to be admitted?
17                MR. BURDICK: Yes. SHINE has submitted 18 Exhibits SHN-001 through SHN-029.
19                CHAIRMAN BURNS: Okay. And I presume you 20 propose to move those into the record?
21                MR. BURDICK: We move to admit those into 22 the record.
23                CHAIRMAN      BURNS:      Okay. Is there      any 24 objection?
25                MS. KANATAS: No objections.
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11 1                    CHAIRMAN BURNS: Okay, very good. So, the 2 list of exhibits is admitted for the Applicant, SHINE.
3                    Okay. Turning to the Staff, counsel, would 4 you introduce yourself, please.
5                    MS. KANATAS: My name is Catherine Kanatas, 6 and along with my counsel, Mitzi Young, we represent 7 the Staff.
8                    CHAIRMAN BURNS: Okay, great. Would you 9 read the names of the proposed Staff witnesses?
10                    MS. KANATAS: Yes, and if they can --
11                    CHAIRMAN      BURNS:      And    I'll ask  them      to 12 stand. Thank you.
13                    MS. KANATAS: Thank you. Alexander Adams, 14 John Adams, Mary Adams, Stephen Alexander, David Back, 15 Marissa Bailey, Daniel Barrs, Thomas Boyle, Gregory 16 Chapman, William Dean, James Downs, Thomas Essig, 17 Kevin        Folk,  Mirela      Gavrilas,        Mary  Gitnick,    James 18 Hammelman, Shawn Harwell, Christopher Heysel, Gregory 19 Hofer, Robert Hoffman, Anthony Huffert, Steven Lynch, 20 Stephen Marschke, Jane Marshall, Nancy Martinez, James 21 McIlvaine, Diane Mlynarczyk, Kevin Morrisey, Michelle 22 Moser, Thomas Pham, Paul Prescott, William Rautzen, 23 Jeffrey Rikhoff, Michael Salay, Alexander Sapountzis, 24 Raymond Skarda, Soly Soto-Lugo, Joseph Staudenmeier, 25 Christopher Tripp, Glenn Tuttle, Carl Weber, Abraham NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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12 1 Weitzberg, and David Wrona.
2                CHAIRMAN BURNS: Okay, thank you.
3                So, for the Staff witnesses, I'll ask you 4 to raise your right hand.
5                Do you swear or affirm that the testimony 6 you will provide in this proceeding is the truth, the 7 whole truth, and nothing but the truth?
8                ALL WITNESSES: I do.
9                CHAIRMAN BURNS: Did any -- please inform 10 me if any of you decline to take the oath. Okay, you 11 may be seated.
12                Is there any objection to including the 13 witness list?
14                MR. BURDICK: No objection.
15                CHAIRMAN BURNS: Okay. So, proceed to the 16 admission of the evidence on behalf of the NRC Staff.
17 Are there any edits, counsel, to your exhibit list?
18                MS. KANATAS: There are no edits.
19                CHAIRMAN BURNS: Would you read the range 20 of numbers on the list of exhibits to be admitted?
21                MS. KANATAS: Staff exhibits run from NRC-22 001 through NRC-013.
23                CHAIRMAN BURNS: Okay. And I presume you 24 would move to admit those exhibits into evidence.
25                MS. KANATAS: We would like to move to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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13 1 admit them into the record.
2                CHAIRMAN BURNS: Are there any objections?
3                MR. BURDICK: No objection.
4                CHAIRMAN      BURNS:      Okay. And seeing      no 5 objection, the exhibits are admitted. So, thank you 6 for those -- we got through the preliminaries.
7                I think at this point we're ready to have 8 the Overview Panel for SHINE. And for this portion of 9 the proceeding we'll have the Overview Panel from 10 SHINE, and I believe then we have the questions on the 11 Overview Panel, and then we'll have the Staff Panel.
12 So, thank you, counsel.
13                And, again, this is an Overview Panel for 14 opportunity for the Applicant to provide us overview 15 of the application and the proposed project. I would 16 remind the witnesses that you remain under oath. You 17 may assume that the Commission is familiar with the 18 pre-hearing filings on behalf of the Applicant, as 19 well of the Staff. And I would then ask the panelists 20 to introduce themselves. I'll start here.
21                MR. PIEFER: Yes, sir. My name is Greg 22 Piefer. I'm the founder and CEO of SHINE Medical.
23                MR. HENNESY: My name is Bill Hennesy. I'm 24 the Manager of Engineering for SHINE.
25                MR. COSTEDIO: My name is Jim Costedio. I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 the Licensing Manager for SHINE.
2                  MR. VAN ABEL: My name is Eric Van Abel.
3 I'm the Engineering Supervisor for SHINE.
4                  CHAIRMAN      BURNS:          Okay. Thank      you, 5 gentlemen. And you may proceed with your presentation.
6                  MR. PIEFER: So, once again, my name is 7 Greg Piefer, and I want to thank the Commission, 8 Commissioners, Mr. Chairman for your consideration of 9 this very important matter. To start it off, I'd like 10 to give you guys a little bit of background on SHINE 11 and our mission as a company.
12                  SHINE Medical Technologies is dedicated to 13 being        the world    leader      in    the    clean,  affordable 14 production of medical tracers and cancer treatment 15 elements commonly known as medical isotopes by the 16 medical community.
17                  We recognize fully that in order to run 18 this business successfully our highest priority needs 19 to be on safety and reliability of the processes used 20 to produce these isotopes. At the end of the day, 21 these products will serve the needs of approximately 22 100,000 patients per day around the globe making this 23 a very, very significant endeavor in terms of health 24 care of patients. Of course, we can't operate the 25 plant at all if we're not focused on safety in our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 house, and so those are the highest sort of values 2 within the company.
3                    Also interesting is that we come with this 4 technology to the market at a very interesting time 5 when      there    is  a  tremendous        amount      of  transition 6 happening in the existing supply chain for these 7 medical isotopes. Currently, the only producer in the 8 Western Hemisphere of any significant volume will be 9 leaving        the  market      permanently          in  2018,  and      the 10 products have a 66-hour half-life, the most commonly 11 used product has a 66-hour half-life, and that creates 12 substantial challenges for U.S. patients here if we 13 need      to  bring    all    of    our    medical      isotopes      from 14 overseas. Next slide, please.
15                    Just a little bit more background on the 16 primary        medical      isotope      that      the  world      uses.
17 Molybdenum-99 decays into a daughter, technetium-99m, 18 and      is    used  in  about    85    percent      of  the  nuclear 19 medicine scans performed globally.
20                    Technetium-99m is extremely versatile. Its 21 chemistry allows it to attach itself to a wide variety 22 of drugs where it acts as a tracer, and essentially 23 allows doctors to see what that drug is doing. It has 24 a 6-hour half-life and so it is very difficult to 25 distribute as technetium, but because it's a daughter NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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16 1 of molybdenum-99 which has a 66-hour half-life, you 2 can distribute it around the globe fairly easily.
3                  Collectively, these procedures make up 4 about 40 million doses on an annual basis, so very, 5 very high volume, and very important to patients all 6 around the world, the U.S. being approximately half of 7 those doses.
8                  The pie chart included on Slide 3 shows a 9 breakdown      of  the    procedures          primarily  that      use 10 technetium-99m. I'm just going to call your attention 11 to two of the slices. The largest slice is labeled 12 myocardial profusion. Myocardial profusion is just a 13 way of saying looking at blood flow through the heart 14 muscle and, in fact, is commonly known as a stress 15 test. If a doctor wants to know where to put a stent, 16 if a patient is having chest pain they'll do this. If 17 they want to see if the heart has been damaged by a 18 heart attack, they'll do this test, so very, very 19 useful when you look at the number one killer of human 20 beings in the United States, cardiac disease. And the 21 number two use is for something called a bone scan 22 which is used to stage cancer. And that is the number 23 two      killer  of  people      in    this      country. So,    very 24 important products, very widely used today, and it's 25 very important that the supply chain remain robust for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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17 1 many, many years to come. Next slide, please.
2                  However, it is not clear that the supply 3 chain will remain resilient on the current track 4 without new production. In fact, it looks like it will 5 not be able to meet the needs, the growing needs of 6 the globe in terms of medical isotope production.
7                  I mention the Canadian reactor is exiting 8 the market permanently in March of 2018, and they 9 actually plan to decommission that reactor, at which 10 time the Western Hemisphere will not have a source 11 barring new entrants coming in. And this is not going 12 to create just a problem over here, but it's going to 13 create a global problem. In fact, the Nuclear Energy 14 Agency        as part  of    the    Organization        of  Economic 15 Cooperation        and    Development        has    been  performing 16 studies on exactly this situation for the last several 17 years, and we've included a small bit of data from the 18 most recent study which shows current demand growth in 19 the green line, and current production capacity in the 20 orangish line. As you see, it kind of dips down when 21 Canada leaves.
22                  I'll note that this demand graph does 23 include something called outage reserve capacity and 24 so, you know, there's a little buffer on what's 25 actually required, but that's important. That's what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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18 1 the market needs in order to operate reliably and 2 insure that patients can get the products they need 3 and manage the occasional outage because the supply 4 chain is on the order of 50 to 60 years old in most 5 cases, the research reactors producing this isotope.
6                So it's a very, very, I think, stressful 7 situation for the medical community right now not 8 knowing where their answers are going to lie in the 9 long term, and that problem creates an opportunity for 10 new technology to come in and sort of change the way 11 we've been making medical isotopes in this country, 12 and really do it in a better way. And that's what we 13 believe we've done here. You're going to hear a lot 14 more about how we plan to do that as the day goes on.
15                But when we developed this technology, 16 we've been working on it since about 2006, we had some 17 core values as a company when we founded the company 18 that really are embodied by the technological approach 19 you're going to hear about. And, obviously, as I 20 mentioned in the beginning, we believe at the very 21 highest level that it is impossible to run this 22 company without protecting the health and safety of 23 our workers, the public, and the environment, so these 24 have been factors in our consideration from day one 25 when we were looking at what technologies to choose NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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19 1 and what approach to go forward on.
2                On top of that, we need to insure based on 3 the short half-life of these products that we can get 4 the product out regularly, on time every time. Again, 5 with 66 hours, you know, there's really no forgiveness 6 for substantial delays. It just means that patients 7 aren't going to get the products they need if you 8 can't deliver. And that's unfortunate if a patient 9 presents with chest pains and a doctor is concerned 10 they may have had a heart attack and has to tell them 11 to come back, you know, maybe in a week and hope you 12 make it, or has to give them an alternative isotope 13 that will leave them radioactive for weeks. Stay away 14 from small children for quite some time. It's just not 15 good for the patients, so we need to get this out 16 every single time.
17                We    also      needed        to  insure      cost-18 effectiveness. We had to insure an approach that would 19 allow us to make medical isotopes that can be bought.
20 You know, it's a time when reimbursement is generally 21 across the board decreasing in the United States, and 22 it's important that a cost-effective technology be 23 developed so that this doesn't become prohibitive in 24 terms of cost for patient access.
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20 1 strong in our minds since the beginning is that it's 2 not necessary to use highly enriched uranium to make 3 medical isotopes; however, it is commonly used around 4 the globe today. So, we designed our process to 5 eliminate the need for highly enriched uranium and, in 6 fact, use only low enriched uranium as part of our 7 process.
8                The risk posed to the U.S. public by the 9 proliferation of highly enriched uranium is extremely 10 high. If there were to be an event, the consequences 11 would be disastrous, and we fully support the U.S.
12 Government's initiatives to remove highly enriched 13 uranium from the supply chain and, in fact, stop 14 shipping it around the world to insure that we have 15 appropriate medical tracers.
16                So, these are all things that drove our 17 mission and drove our values, or drove our technology 18 rather. So, I'm going to just give you a high level 19 view of the technology and how it reflects those 20 values.
21                Fundamentally, the biggest protection that 22 we have is that these systems have been designed to be 23 small, and I'm talking about small in terms of thermal 24 power equivalent. When you look at a SHINE production 25 unit or radiation unit, you'll hear more about this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 throughout the day, the thermal power of one of these 2 systems is on the order of 100 kilowatts when its 3 producing at full tilt. If you were to compare this to 4 a reactor like the NRU which is also producing medical 5 isotopes      today,    that      reactor's        thermal      power 6 equivalent is 135 megawatts, so there's about a factor 7 of 1,000 difference in thermal power from a SHINE-8 based system to a reactor-based system. And that has 9 tremendous      safety    benefits      for    us,  including      low 10 source term and very low decay heat. If we shut one of 11 our systems within hours, just a few hours we're down 12 to about a kilowatt of decay heat, so we're talking 13 about something that's less than a hair dryer. So you 14 don't have a lot of the concerns you would have with 15 loss of power in much larger facilities.
16                In addition to the safety benefits just 17 from the lower source term and lower decay heat, of 18 course, we're producing less radionuclides overall 19 that a much larger reactor would do, and that allows 20 us to use commercial disposal for much, if not all, of 21 our disposal path. It's a great economic benefit and 22 certainty benefit in terms of final disposition of 23 waste products.
24                Secondly, we developed a low enriched 25 uranium target that is not only novel in terms of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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22 1 being aqueous, the target is in a liquid form, but 2 it's also the first target that I'm aware of that is 3 reusable. And the reusability of our target actually 4 gives us a substantial economic advantage.
5                Currently      in    the    supply chain,    metal 6 targets are used, solid targets are placed next to a 7 reactor core. They're irradiated. Much of the uranium 8 does not fission, they're dissolved and the medical 9 isotopes are extracted out, and the rest of the 10 uranium is essentially thrown away. Well, in fact, 11 since it's highly enriched uranium in most of these 12 cases, it's thrown into tanks and very carefully 13 monitored. But the reusable target for us is a major, 14 major improvement.
15                And, finally, the system is driven by a 16 low      energy  electrostatic        accelerator. I  say      low 17 energy, that's about 300 kilovolts, 300 kilo electron 18 volts beam energy. And if you were to compare that to 19 a cyclotron that would be found in a pharmacy today 20 that makes isotopes such as fluorine-18, those are on 21 the order of 10 MeV, Mega Electron Volts, so it's much 22 lower, much simpler accelerator that we're using to 23 drive this target. And that also allows us to operate 24 below criticality.
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23 1 the past and they operate at criticality with control 2 rods.        We've  chosen      for    a    number    of  reasons      to 3 eliminate        criticality      all    together      and  use    this 4 accelerator system to drive the liquid target. And 5 that gives us, again, substantially less waste by 6 eliminating the need for a reactor as the primary 7 neutron source. It is also proven, demonstrated, and 8 fairly cost-effective technology that actually people 9 can come and see if they'd like. It's in our lab.
10                    So,    I      guess      that      concludes        my 11 presentation. I'm going to turn the rest of the 12 overview over to Jim Costedio.
13                    MR. COSTEDIO: Good morning. Next slide, 14 please.
15                    The  SHINE      facility        is  located    on    a 16 previously undeveloped 91-acre parcel in the southern 17 boundaries of the City of Janesville in Rock County, 18 Wisconsin. If you look at the map, the area outlined 19 in red on the southern boundary is Rock County. Next 20 slide, please.
21                    The SHINE facility layout consists of an 22 irradiation facility or the IF, and a radioisotope 23 production facility, or the RPF. The area outlined in 24 blue is the irradiation facility which houses the 25 irradiation units, and the area outlined in red is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 radioisotope production facility which houses the hot 2 cells. The facility is relatively small compared to 3 the size of the parcel. It's a 91-acre parcel, and the 4 facility      is  about      55,000      square    feet  centered 5 approximately in the middle of the parcel. Next slide, 6 please.
7                  The SHINE IF consists of eight subcritical 8 irradiation units which are comparable in thermal 9 power level and safety considerations to existing non-10 power reactors licensed under 10 CFR Part 50. However, 11 due to the subcriticality, the irradiation units did 12 not      meet  the  existing        definition      of  utilization 13 facility in 10 CFR 50.2. To align the licensing 14 process with the potential hazards, the NRC issued a 15 direct final rule modifying 10 CFR 50.2 definition of 16 utilization facility to include the SHINE irradiation 17 units. An irradiation unit consists of a subcritical 18 assembly, a neutron driver and supporting systems.
19 Next slide, please.
20                  The radioisotope production facility is a 21 portion of the SHINE facility used for preparing 22 target solution, extracting, purifying, and packaging 23 moly-99, and the recycling and cleaning of target 24 solution. Based on the batch size of greater than 100 25 grams, the RPF meets the definition of a production NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 facility as defined in 10 CFR 50.2. Next slide, 2 please.
3                  SHINE    submitted        a    construction      permit 4 application in two parts pursuant to an exemption from 5 10      CFR    2.101. Part      one    of    the      application      was 6 submitted        on  March    26,    2013    which      included      PSAR 7 Chapter 2 on site characteristics, PSAR Chapter 19 for 8 the environmental review, and general and financial 9 information. Part two of the application was submitted 10 May 31st, 2013 which provided the remaining PSAR 11 chapters. And then a discussion of preliminary plan 12 for coping with emergencies in accordance with 10 CFR 13 50.34(a)(10) was provided September 25th, 2013. The 14 SHINE facility will be licensed under 10 CFR Part 50, 15 Domestic        Licensing    of  Production          and  Utilization 16 Facilities. Next slide, please.
17                  SHINE used for regulatory guidance and 18 acceptance criteria, SHINE used NUREG-1537 guidelines 19 for preparing and reviewing applications for licensing 20 of non-power reactors, and the Interim Staff Guidance 21 augmenting        NUREG-1537      Parts      1      and  2. The      ISG 22 incorporated relevant guidance from NUREG-1520, a 23 Standard Review Plan for the review of a licensed 24 application for a fuel cycle facility. SHINE also used 25 additional guidance such as regulatory guides and ANSI NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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26 1 Standards in developing the application.
2                  That ends my presentation. I'll now turn 3 it    over    to  Eric    Van  Abel      to    discuss the    SHINE 4 technology.
5                  MR. VAN ABEL: Next slide, please.
6                  Good morning. I want to give a brief 7 overview of the process and technology that SHINE 8 plans on using. In this slide, as Jim showed there, 9 there's two main areas of the production facility 10 building. There's an irradiation facility, an IF, and 11 a radioisotope production facility, an RPF. I'm going 12 to go through the processes in these two areas in the 13 next few slides. Next slide, please.
14                  Here's a general schematic of the overall 15 SHINE process overview. Just to orient you relative to 16 the last figure, the TSV and Irradiation Unit Cell in 17 the left there is part of the irradiation facility, 18 and the other components on this diagram are all part 19 of the RPF.
20                  So, we begin our process in the bottom 21 there at the target solution preparation step. In that 22 process we dissolve uranium in sulfuric acid and 23 produce what we call target solution. That target 24 solution is then moved to a hold tank is which is 25 number 2 on the figure there. There's one of these NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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27 1 hold tanks for each of our eight irradiation units so 2 there's eight hold tanks. Those hold tanks are staging 3 areas prior to the radiation cycle, so in that hold 4 tank we'll measure the uranium concentration, the pH 5 to insure that the parameters are correct to begin the 6 irradiation cycle. And then once we're ready to begin 7 we'll start pumping that solution over to the TSV in 8 discrete batches. We'll fill up the TSV for the proper 9 level and then once the TSV is at the proper level we 10 begin        the irradiation      process        by energizing      the 11 neutron driver which is our accelerator that Greg 12 mentioned.
13                  That accelerator runs for approximately 14 five and a half days. We irradiate the solution, 15 produce medical isotopes of interest in the solution, 16 and then we -- once we're done with the irradiation 17 process we drain that solution to a dump tank located 18 right in the irradiation unit cell.
19                  The solution is held there for a short 20 period to decay, and then once we're ready to process 21 it we transfer it over to the super cell, which is 22 number 4 on the figure there. The super cell is just 23 a larger hot cell that has several processes inside a 24 single hot cell. And the first part of that process is 25 the extraction process. And that's where we actually NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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28 1 separate out the moly-99 from the other isotopes in 2 the solution.
3                    And then most of the time the uranium 4 solution just goes right on to the recycle tank which 5 is    number    5  in  the    figure.      And    there  it's    just 6 recycled back into the process and it goes in a loop.
7 It goes to another hold tank, to another irradiation 8 cycle.
9                    Occasionally, we also send it to the UREX 10 process which is item 6 in the figure there. And 11 that's where we periodically clean up the solution, we 12 remove the uranium from the other fission products 13 using        solvent  extraction        technology      UREX,  and      we 14 recover the uranium and recycle that back into the 15 process. So, we just send that back to the target 16 solution        preparation      steps      and      recreate    target 17 solution again. Next slide, please.
18                    In the irradiation facility, SHINE has a 19 system that couples fusion and fission technology, so 20 we have an accelerator that's fusion-based, deuterium-21 tritium fusion-based accelerator coupled to a fission-22 based subcritical assembly. The little diagram on the 23 right there shows a schematic of that process. In the 24 accelerator        we  accelerate        deuterium      ions  into      a 25 tritium gas target. That results in the production of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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29 1 fusion        neutrons,    14    MeV    fusion        neutrons. Those 2 neutrons than pass through a component we call the 3 neutron multiplier. In that multiplier the yield of 4 neutrons        is  increased      and    then      the neutrons      are 5 transferred          into  the    target      solution.      The    target 6 solution is where the uranium is actually located.
7                    In the target solution there's subcritical 8 multiplication so the fission occurs, it causes more 9 fission but in a subcritical process. And then that 10 fission yields the radioisotopes of interest directly 11 in      the    solution    for    ready      extraction      from      the 12 solution.
13                    There are additional supporting systems 14 including a light water pool system. The entire system 15 is located in a pool similar to a research reactor.
16 The target solution vessel off gas system, as I'll 17 mention in a few slides here, manages the gas products 18 from the fission process. The primary closed loop 19 cooling systems cools the TSV during the irradiation 20 process, and there's a tritium purification system 21 that supplies clean gases to the accelerator for the 22 irradiation.
23                    It's important to note that this process 24 is done at essentially atmospheric pressure. It's a 25 low temperature, low pressure process. These aren't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 highly pressurized, high temperature systems like a 2 power reactor would be. The target solution at the end 3 of the irradiation cycle is simply drained to a dump 4 tank, as I mentioned, right in the irradiation unit so 5 that's a passively cooled, safe-by-geometry tank to 6 store        the  solution.      And    that's      drained  through 7 redundant fail-open dump valves.
8                    The TSV itself is just an annular, a 9 simple        annular  vessel      constructed        of Zircaloy,      a 10 widely used alloy in the nuclear industry. And there's 11 no pumping of the solution while irradiating it. It's 12 just naturally convected inside of the vessel. Next 13 slide, please.
14                    This slide shows just a rendering of the 15 subcritical assembly. The outer vessel in the center 16 there is the subcritical assembly support structure, 17 the SASS. This is a secondary vessel that surrounds 18 the TSV. The TSV is internal to that along with the 19 neutron multiplier. SASS is just there in case there's 20 a leak in the TSV, that solution would be contained 21 inside of that. The dump tank is located directly 22 below it there, and there are dump and overflow lines 23 from the TSV to the dump tank to connect it. Next 24 slide, please.
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31 1 in red on this figure. Directly above that is the 2 accelerator. The accelerator sits on a grating above 3 the pool and the accelerator is in yellow in this 4 picture. It's an electrostatic accelerator, a simple 5 accelerator technology. As Greg pointed out before, it 6 generates fusion neutrons from DT fusion that drive 7 the        fission  process.        When      we    shut  down      the 8 accelerator, the fission process terminates because 9 the subcritical assembly is never at critical.
10                  The tritium purification system is not 11 shown in this figure, but it's also in the irradiation 12 facility. And that system separates gases from the 13 accelerator, so the accelerator as it's operating, 14 it's      mixing  deuterium      and    tritium    together.      The 15 tritium purification system separates those back apart 16 and      resupplies    the    purified      tritium    back  to    the 17 accelerator for continued operation. And the tritium 18 lines for that system and the processing equipment are 19 in glove boxes and double-walled pipe. Next slide, 20 please.
21                  The TSV off-gas system is shown in green 22 on the figure here. That system is directly adjacent 23 to the irradiation unit cells. That system contains 24 the fission product gases that are generated in the 25 TSV during irradiation. It removes iodine from the gas NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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32 1 stream, and also its major function is to recombine 2 hydrogen and oxygen. So as we irradiate the solution, 3 radiolysis of the water generates hydrogen and oxygen, 4 and this system sweeps sweep gas air over the target 5 solution vessel to dilute the hydrogen and send it to 6 a recombiner, and then recombine the water and return 7 that water back to the TSV, so it's just a closed 8 loop.
9                The subcritical assembly, as I mentioned 10 before, is immersed in a light water pool. That pool 11 provides significant radiation shielding and decay 12 heat removal. Next slide.
13                For the irradiation process, when we're 14 ready to begin the irradiation we measure the relevant 15 parameters of the target solution, such as uranium 16 concentration, pH, any other chemical parameters that 17 we need to determine, and then we begin moving the 18 solution is discrete batches over into the target 19 solution vessel. We measure the count rate at each 20 step there and from that we can do the 1/M process 21 that's used in reactors all over the world to predict 22 the critical state of the assembly. And the difference 23 with us is that we increase volume, we predict where 24 the critical state is, and we never go there. We stop 25 5 percent by volume below critical. And that's our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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33 1 highest reactivity point for the system.
2                    And  during        that      process    there        are 3 automatic safety systems that are monitoring and will 4 initiate a shutdown on high neutron flux or primary 5 coolant temperature should the operators not stop the 6 system        before    that.      And    that        would  prevent        a 7 criticality. Next slide, please.
8                    Once we begin the irradiation process we 9 isolate that batch of uranium solution in the TSV so 10 it's a fixed target, fixed batch of solution. We close 11 the fill valves, the redundant fill valves and isolate 12 the      fill    pump  from    the    system.        We  energize      the 13 accelerator,          and    then    we    begin      slowly  supplying 14 tritium to the accelerator and that causes the output 15 of      accelerator      to    gradually        increase,    and      that 16 increase in the neutron output of the accelerator 17 results in increased fission power in the TSV. That 18 fission power results in increased temperature and 19 void fraction in the TSV which the system has very 20 strong inherent negative feedback coefficients so the 21 increase        in  temperature        and  void      fraction    causes 22 reactivity to drop significantly in the system. And we 23 don't do anything to compensate for the reactivity 24 drop. We let the system drive further subcritical.
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34 1 half days, and then following shutdown we drain the 2 solution into that dump tank where it's passively 3 cooled. Normally, we're maintaining the temperature of 4 that pool but should we lose offsite power or active 5 cooling for any reason of the pool, there's sufficient 6 heat capacity in the pool for a temperature rise of 7 only 12 degrees after 90 days without cooling, so it's 8 a large body of water. There's very little decay heat 9 because this is such a small system. Next slide, 10 please.
11                In the radioisotope production facility 12 once we're ready we transfer that solution over to the 13 RPF and there we extract the moly-99. We have a 14 purification process that it then goes to. This is the 15 LEU modified Cintichem process where it's a laboratory 16 scale glassware process that's done in the hot cell 17 just to purify the product. And then we package it and 18 get it ready for shipment to customers.
19                In  the    RPF    there's        also a noble      gas 20 removal system, the NGRS. This system collects those 21 off gases from the TSV off gas systems, the ATSV off 22 gas system stores them, holds them for decay for 40 23 days prior to sampling, and then a filtered monitored 24 discharge to our process vessel vent system.
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35 1 recycling and cleaning the target solution, the UREX 2 process. That's, as I mentioned before, a solvent 3 extraction process that separates the fission products 4 and      plutonium    from      the    uranium.        The  uranium        is 5 recovered        for  reuse      in  the    process.      Next    slide, 6 please.
7                  In the SHINE facility we used engineered 8 safety features to protect public health and safety, 9 and these are principally confinement. It's important 10 to    note    that  our    inventory      in    any  one  of    these 11 confinement areas is approximately 10,000 times less 12 than the radionuclide inventory in a power reactor, so 13 they're much lower inventory which reduces the risk.
14 And also these are low temperature, low pressure 15 processes so there's not a lot of stored energy to 16 encourage        dispersal,      so    there's        lower  dispersion 17 forces which, of course, reduces releases.
18                  The confinement functions themselves are 19 provided by the biological shielding. There's -- over 20 most      of  the  processes        there's        thick  reinforced 21 concrete biological shielding, usually several feet 22 thick        concrete. Isolation        valves      on  the    piping 23 systems, ventilation systems play an important role in 24 the confinement features. As shown in the figure on 25 the right there, that shows you some of our cascaded NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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36 1 ventilation zones. From Zone 1 to Zone 4 there's a 2 pressure gradient with Zone 1 being at the lowest 3 pressure, so any potential contamination is reduced 4 outside of those areas in Zone 1 where radiological 5 materials are normally stored. And in any accident 6 scenario, those areas in red on the figure there are 7 the areas where isolation would principally occur and 8 contain that material should an accident occur. And 9 also, of course, instrumentation and control systems 10 that actuate the confinement features. Next slide, 11 please.
12                  So as described in SHINE's PSAR, we have 13 a preliminary design that shows that we can construct 14 this      facility  to    meet      the    applicable regulatory 15 requirements. We've identified robust engineered and 16 administrative controls to insure that we can protect 17 public health and safety, the environment, and our 18 workers, and that we are certainly designing this 19 plant with safety as our primary criterion. And that 20 concludes my presentation.
21                  CHAIRMAN BURNS: Does that conclude the 22 presentations?
23                  MR. PIEFER: It does.
24                  CHAIRMAN BURNS: Okay, thank you. Starting, 25 we'll have Commissioner questions now. We'll start --
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37 1  I'll start off this round of questioning.
2                  Just to make sure I understand the design 3 facility laid out, each of these individual -- the 4 eight        TSVs,  these      are    essentially      independent.
5 Correct?
6                  MR. VAN    ABEL:    Yes.      Yes,  they    can      be 7 operated independently run. We can run anywhere from 8 zero to eight of them.
9                  CHAIRMAN BURNS: Okay. So, there's no real 10 interconnection between them.
11                  MR. VAN    ABEL:    There      are  some    shared 12 systems, like the ventilation system is common to 13 them. There's a common chilled water system that's 14 supplying chilled water to the heat exchangers.
15                  CHAIRMAN BURNS: Okay.
16                  MR. VAN ABEL: But the individual primary 17 cooling systems are unique for each one.
18                  CHAIRMAN BURNS: Okay, thank you.
19                  A couple of questions. Could you give me 20 an idea of what level of public engagement you had in 21 terms of the site selection process for the facility, 22 and the type of feedback you got from that? I guess, 23 Mr. Piefer, that might be for you.
24                  MR. PIEFER: Yes. I actually would like to 25 call Katrina Pitas to the witness stand.
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38 1                CHAIRMAN BURNS: Okay.
2                MR. PIEFER:        She's      got that    pretty 3 thoroughly. Are you ready?
4                MS. PITAS: I think so.
5                MR. PIEFER: Okay.
6                CHAIRMAN BURNS: Well, come -- Ms. Pitas, 7 come up to the podium here. And what I'd ask you to 8 do, and just for other witnesses, when you come up 9 identify yourself, your position. And I remind you 10 you're -- and I presume you took the oath. Yes, I saw 11 you take the oath, and you remain under oath.
12                MS. PITAS: Thank you.
13                CHAIRMAN BURNS: So, thanks.
14                MS. PITAS: So, my name is Katrina Pitas.
15 I'm the Vice President of Business Development for 16 SHINE.
17                Our site selection process involved 11 18 criteria which I'd be happy to go through, but in 19 terms of public involvement, the individual community 20 governments that we were working with during the later 21 stages of our site selection process were very -- we 22 had a very good relationship with all three of the 23 sites that we considered, the specific sites that we 24 considered. And then once we chose Janesville, that 25 relationship has continued to grow, and we believe we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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39 1 have a very good relationship with that community. And 2 I'd be happy to go into some of the actions we've 3 taken        to insure    a    good    relationship        with      the 4 community, if you'd like.
5                  CHAIRMAN      BURNS:      Well,    I  just  --      yes, 6 briefly.
7                  MS. PITAS:      Sure.      So,  once    we    chose 8 Janesville, we set up twice yearly public meetings 9 that were open to the entire community. They were just 10 informational      sessions        where      Greg    would    give      a 11 presentation on our progress, the type of facility, 12 and      what  the  company      was    aiming      to  do    in    the 13 community. And then we also have recently started 14 giving twice yearly updates to the city council which 15 are open sessions, so that makes a total of four times 16 a year we meet directly with the community. It's open 17 to anyone to ask whatever questions they have, voice 18 concerns. And the result of that has been truly -- a 19 relationship based on mutual respect and trust. So, 20 it's been very positive.
21                  CHAIRMAN BURNS: Thank you very much.
22                  The other question I have goes to the 23 nature of what the application is for, which is a 24 construction permit. As I noted earlier, more recently 25 the Commission has been -- has held hearings on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 Combined      Licenses    which    is    by    intention  a    more 2 comprehensive review, maybe not more comprehensive but 3 it's a broader scope of review because it is actually 4 the construction permit and the ultimate operating 5 license combined.
6                  With  a    construction          permit there      are 7 important design parameters that have to be met, 8 requirements that have to be met. But as with the 9 current generation of operating plants in the U.S.,
10 going through the construction permit process allows 11 some completion of certain design features, updating 12 all that.
13                  Could you give me sort of a feel of, if a 14 construction permit is issued, what are, in effect, 15 the things you would see that need to be worked on 16 from a design perspective before we come to the next 17 phase which would be the operating license. What are 18 the things that are still, in a sense, open? And I 19 don't mean open in a negative way, but it's the idea 20 that the Applicant may have some design issues that it 21 needs to address and to resolve prior to a final 22 determination on operating license.
23                  MR. HENNESY: I'll take this one. This is 24 Bill Hennesy, the Engineering Manager.
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41 1 preliminary design where we've outlined the principal 2 design features and the technology that we're going to 3 use. So, the next phase of design will be to go into 4 detailed design where we'll actually work through the 5 details, the many, many details that are needed to get 6 to the construction stage. So, there aren't any real, 7 other than the research and development which we've 8 outlined separately, there aren't any real issues that 9 we need to do other than just the hard work of 10 engineering that's required to move on.
11                  CHAIRMAN BURNS: Okay. So, you're not --
12    there      aren't    what      I'll      call    big  gaps,      any 13 particularly big gaps in terms of sort of filling in.
14 It's      primarily  the    engineering        work,  getting      the 15 design from paper to the actual facility and all that.
16                  MR. HENNESY: Yes, that's correct.
17                  CHAIRMAN BURNS: Okay, thank you. Thank you 18 very much. Commissioner Svinicki.
19                  COMMISSIONER SVINICKI: Good morning and 20 welcome to all of the SHINE witnesses, the Applicant 21 witnesses that are here today and others who have 22 participated in this very complex undertaking.
23                  As a former resident of Dane County, it 24 was a long time ago, I'm familiar with the general 25 geographic and demographic area that you're talking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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42 1 about.        This  is    a    significant          new  facility      and 2 capability for that kind of a more agricultural and 3 rural area. I appreciate that you have done a lot of 4 community education and awareness of this activity. I 5 might suggest to you that if the construction permit 6 is issued and large-scale construction activities 7 start taking place, I think you might have to cover 8 some of the same territory because that's when the 9 community really becomes engaged and very interested 10 when they start noticing all of that activity. And 11 then they will -- a number of them I'm sure will begin 12 their inquiry into exactly what you're doing there.
13 So, it's good that you've got the structure in place 14 to begin to educate and communicate with people about 15 what it is that you are undertaking.
16                    I  note      also,      this      is  an  overview 17 presentation so I'm going to ask some questions that 18 may or may not have a direct relevance to the findings 19 that the Commission will make in order to make a 20 decision on authorizing the construction permit per 21 se.
22                    You provided in your overview presentation 23 some NEA statistics on the projected growth in the use 24 of the product that would come out of the SHINE 25 facility.        I  don't      believe,        though,    that    those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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43 1 projections give any indication of the great swaths of 2 the globe where people are medically under-served and 3 so it doesn't really capture upon the demonstration of 4 a new technology that doesn't use HEU the potential 5 long term maybe to have more penetration of these 6 types        of  diagnostic      techniques        where  arguably      in 7 medically under-served areas of the globe they could 8 do even greater good than they do in areas that have 9 access to a lot of alternatives, or perhaps more 10 invasive procedures.
11                    So, it is interesting that there is a 12 large public good that comes out of constructing a 13 facility like this. Of course, that cannot have a 14 direct        bearing  on      a  safety        determination.      The 15 facility, you know, either is or isn't going to be 16 safely operated, so we have to set that aside. But in 17 my preparation for the mandatory hearing today on the 18 construction permit I couldn't help but think that if 19 any of the SHINE witnesses are fans of Monty Python, 20 it's the opportunity to say "And now for something 21 completely        different."      So,    the    Chairman  has    made 22 reference to the fact that we've been looking a lot at 23 power reactor mandatory hearings, so this was a chance 24 to work our minds around something that is very 25 different.
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44 1                    It's commendable for the NRC Staff, and 2 I'll make this point in their overview presentation.
3 They've used what I call an adaptive process, meaning 4 there was no part of the Code of Federal Regulations 5 that SHINE or the NRC Staff could turn to and say oh, 6 for this type of medical isotope production, here is 7 the regulatory framework. So, as you look forward 8 there        are  elements      of    your    design      that  are      not 9 complete, there is a research and development program 10 and      plans    that    you    have    to    close    on  technical 11 uncertainties that the NRC Staff has, of course, 12 reviewed. And that is part of their finding is to see 13 that you have plans and programs in place to complete 14 and      answer    questions        about      area    of  technical 15 uncertainty.
16                    But  would      SHINE        assess    --  as      the 17 Applicant, do you assess that this adaptive process, 18 a kind of going to things, guidance, regulations that 19 we have in place, deciding which portions of those 20 standing procedures and regulations were or were not 21 relevant to the technology you were proposing, and 22 then applying that and going through a Request for 23 Additional Information process? Would you say that you 24 found        that  process      workable      to      get  through    this 25 construction permit stage? And what would you offer in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 terms of your confidence in continuing to pursue that 2 kind of adaptive process at the operating license 3 stage? And embedded in that, could you address what 4 percent of design do you think you are complete, if 5 you had to put a number on it?
6                  MR. PIEFER: So, I think the answer is yes, 7 and I'm going to turn it over to Jim to do a little 8 bit more comments on the process.
9                  MR. COSTEDIO: I think the process is very 10 workable. All the way through we've met several times 11 with the Staff, we've had public meetings to work 12 through some of the issues, you know, you talked about 13 that      the code  doesn't      specifically        in  all    cases 14 clearly, I mean, address us, but we were able to work 15 through that during the public meetings with the 16 Staff.
17                  COMMISSIONER        SVINICKI:        Do  you  see      it 18 basically      carrying      forward      into      the  --  if      the 19 construction permit is issued, do you see this same 20 process basically carrying forward in the same form to 21 the operating license phase?
22                  MR. COSTEDIO: Absolutely.
23                  COMMISSIONER SVINICKI: Okay. And would you 24 say then that in terms of uncertainties for you going 25 forward, you do have certain proof of concept and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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46 1 technical issues that you have plans in place to close 2 on. There's also regulatory uncertainty that exists at 3 some level. Would you say regulatory uncertainty or 4 technical and proof of concept uncertainty, which of 5 those would dominate the uncertainty going forward for 6 you, or perhaps it's financial.
7                MR. COSTEDIO: I would think the regulatory 8 uncertainty.
9                MR. PIEFER: Yes, of those two, I would 10 agree. I think the -- we've done enough technology 11 demonstrations at this point, including a recent demo 12 where General Electric made injectable drugs out of 13 our process, and they looked beautiful. So, we feel 14 pretty confident in the technology at this point.
15 There's a few things outstanding in terms of longevity 16 of the plant, et cetera, that are being worked on as 17 we go forward; corrosion studies, for example, that 18 we're going to be interested in finding out the data 19 there. But, you know, timeline and financing, you 20 know, you mentioned financing uncertainty. Those two 21 are tied hand and hand, and so that's another thing, 22 we're in a hurry. We've got to do it right, but 23 obviously given the exit of the reactors we'd like to 24 move as quickly as possible. And up until now, you 25 know, we've been able to move this project forward in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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47 1 a largely serial fashion, which is eliminate risks, 2 perceived risks from investors, and then move forward 3 and get the next slug of money.
4                    COMMISSIONER SVINICKI: Can I ask on that 5 point,        the  draft      construction          permit,  or      the 6 construction permit if issued includes a date by which 7 construction would complete. Do you have a notional 8 time        frame    by    which      you    anticipate      beginning 9 construction? In a non-proprietary basis, is that 10 something you could share in this open meeting?
11                    MR. PIEFER: Yes, I think so. I mean, what 12 does the schedule currently say?
13                    MR. COSTEDIO: Spring of 2017.
14                    MR. PIEFER: Spring of 2017.
15                    MR. COSTEDIO: And we would follow with the 16 OL application about three months later.
17                    COMMISSIONER SVINICKI: Okay. And then the 18 last question I had was, I'm not familiar, though, 19 with the airport facility that would be your nearest 20 facility. Is that a cargo hub, or is it -- what size 21 of aircraft -- how active is that facility? Would you 22 have dedicated flights out of there?
23                    MR. HENNESY:      We    might      have  dedicated 24 flights out of there. That's certainly one thing we're 25 considering,        using    a  carrier        that    would  provide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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48 1 service from that area.
2                    COMMISSIONER        SVINICKI:      Is  the  airport 3 facility currently adequately sized for your projected 4 needs, or are there upgrades to the airport itself?
5                    MR. HENNESY: It would be sized for our 6 needs, yes.
7                    COMMISSIONER SVINICKI: Okay.
8                    MR. PIEFER: It's not used for much other 9 than recreational flying.
10                    COMMISSIONER SVINICKI: I was surprised, 11 frankly, again it was a long time ago, but having 12 lived in an adjacent county, I was surprised that 13 there even was an air facility there. I didn't recall 14 that.        Okay,  thank    you    for    that. Thank  you,      Mr.
15 Chairman.
16                    CHAIRMAN BURNS: Thank you, Commissioner.
17 Commissioner Ostendorff.
18                    COMMISSIONER          OSTENDORFF:      Thank      you, 19 Chairman. Thank you all for your presentations this 20 morning.
21                    I  appreciate        that      my  colleagues    have 22 already highlighted that this is a very different type 23 of hearing than we've had under our Part 52 hearings, 24 so having that philosophical mind set change by your 25 comments was very helpful there, Chairman and for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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49 1 Commissioner Svinicki.
2                    I guess this is a question. I think that 3 Commissioner Svinicki may have asked this, I may have 4 missed the answer, but some question that came up 5 about          the  overall      characterization        of    design 6 completion. What can you say about that?
7                    MR. HENNESY: I'll take that question. We 8 debate this amongst ourselves quite a bit, as you can 9 imagine. The characterization of design complete is 10 variable depending on the systems you're looking at.
11 Some systems are pretty far along like our tritium 12 purification system, and others are still back at 13 conceptual. Where those systems we know we can fill in 14 quickly with, design what we need to, like HVAC. So, 15 overall, I would say the percent design complete is 16 around 15 percent, which I believe is appropriate for 17 being able to say that we've completed preliminary 18 design.
19                    COMMISSIONER OSTENDORFF: Okay. So, let me 20 just stay with you there for a minute on the design 21 piece.          I  appreciate          there's      first-of-a-kind 22 engineering issues here, there's some things that have 23 not been attempted before. What are the top two or 24 three areas, sub-components, is it the TSV, is it the 25 hot super cell? I'm curious as to where do you see the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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50 1 most        difficult  challenges          ahead      on  the    design 2 completion?
3                  MR. HENNESY: We have prototypes built in 4 our lab in Monona, and we're continuing to evolve the 5 TSV design, and the TOGS design, and doing testing on 6 components. And I think that's going on pretty well.
7 I think Eric can comment on that some more.
8                  COMMISSIONER OSTENDORFF: As you answer th 9 is question, can you please maybe give a little more 10 detail on what you have in the form of prototype, 11 mockups, or simulations?
12                  MR. HENNESY: Sure. I'll turn that over to 13 Eric.
14                  MR. VAN ABEL: Yes. We have -- each of 15 these components in that overall process diagram, each 16 of those components has been demonstrated individually 17 either by SHINE, by Phoenix Nuclear Laboratories who's 18 the      accelerator      provider,        or      by  the  National 19 Laboratories. You know, the TSV off-gas system, the 20 one that recombines the hydrogen, that system we have 21 a full-scale prototype in our facility in Monona where 22 we've demonstrated full-scale hydrogen recombination 23 testing flow rates, droplet pickup, various things of 24 engineering interest. We have a tritium purification 25 system prototype in our Monona facility constructed by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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51 1 Savannah River National Lab. We have an accelerator in 2 the Monona facility that we share with Phoenix Nuclear 3 Labs that's demonstrated the full production scale 4 accelerator technology. The TSV, we have a mockup TSV.
5 We can't, obviously, put uranium solution in it, but 6 we have a mockup TSV demonstrating -- that's connected 7 to the TOGS system to demonstrate that that system 8 combined        performance.      And    then      Argonne  National 9 Laboratory is doing experiments on the extraction and 10 purification of our solution, so they've irradiated 11 what they call a mini-SHINE experiment, which is 12 essentially a system very similar to our's from a 13 chemical        standpoint      of    uranyl        sulfate  solution 14 irradiated by an accelerator. They process it through 15 our        same    extraction          technologies,          our      same 16 purification technologies that we plan to use. And as 17 Greg mentioned before, they've shipped product to one 18 of our expected customers and demonstrated that it met 19 the purity specifications that we plan to meet.
20                  COMMISSIONER OSTENDORFF: If you had to 21 draw a comparison between your preliminary design for 22 the      SHINE  facility      and    some    existing      facilities, 23 irrespective        of  location,        are    there    a  couple      of 24 facilities that you think you've borrowed from -- I'm 25 not      talking    about    from    an    intellectual      property NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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52 1 standpoint, but just as far as known processes or 2 procedures?        I'm  trying      to    figure      out  what's      the 3 analogy, if there are any analogies, as to what other 4 existing facilities might be somewhat comparable in 5 some aspects to your's?
6                    MR. VAN ABEL: Yes. So, for the TSV, this 7 is a subcritical assembly, it doesn't go critical, but 8 it shares a lot of the physics and thermal-hydraulic 9 characteristics of aqueous homogenous reactors, AHRs.
10 Those        have  been    built      and      tested      at  several 11 facilities. The SUPO reactor at Los Alamos National 12 Lab      is    one  we  use    a  lot    for      validation.      SILENE 13 reactor, the homogenous reactor experiment done at Oak 14 Ridge, HRE reactor. All these facilities we are using 15 their operational history, transient analysis from 16 them to validate our codes to insure that our codes 17 adequately predict the TSV behavior. Working with Los 18 Alamos        National    Lab    on    that,        so  we  borrowed, 19 essentially,        how    they      ran    their        facilities      and 20 operated those AHRs really to feed the design of the 21 TSV.
22                    The accelerator, as we mentioned, we have 23 a full-scale prototype of that accelerator already.
24 And the LEU modified Cintichem process that we use for 25 purification, that's based -- that originated at the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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53 1 Cintichem facility, which is an NRC -- previously NRC-2 licensed facility that produced moly-99 for commercial 3 sale. There they used a typical solid fuel reactor to 4 irradiate solid targets, but then they dissolved them, 5 and processed them, and purified them similar to our 6 technology, so we've looked at that Cintichem facility 7 and use that technology in our facility, as well, for 8 the processing side.
9                    COMMISSIONER OSTENDORFF: Thank you. That 10 was very helpful. Thank you, Chairman.
11                    CHAIRMAN BURNS: Thank you, Commissioner.
12 Commissioner Baran.
13                    COMMISSIONER BARAN: Welcome. Thanks for 14 being here, and for your presentations.
15                    Following up on this distinction between 16 the construction permit application and the operating 17 license        application,      I'm    interested        in  hearing      a 18 little        bit  about    how    you    decided      what  level      of 19 information to include in the construction permit 20 application. When drafting the application, how did 21 you weigh the benefits of having more issues reviewed 22 by the Staff early in the process against having more 23 flexibility        during    construction,          if  you  were      to 24 receive a construction permit?
25                    MR. COSTEDIO:        Well,        we  provided      the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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54 1 principal design criteria, and the design basis of the 2 structure, systems, and components. From that we were 3 able to do our accident analysis, and the results of 4 the accident analysis shows we're within regulatory 5 limits, within the Part 20 limits. Our definition of 6 safety-related implements those requirements on 10 CFR 7 20 and Part 70.61 for the performance requirements.
8 So, you know, we believe that we've provided the 9 necessary      information      to    obtain      the construction 10 permit.
11                COMMISSIONER BARAN: In the final ACRS 12 letter to the Commission, the ACRS raised seven topics 13 to be further addressed in the application for an 14 operating license. Pre-hearing Question 4, explore 15 this issue, and your response indicated that these 16 topics are not included as commitments in Appendix A 17 of the Safety Evaluation Report. How will SHINE insure 18 that      the ACRS  topics      will    be    addressed  at    the 19 operating license stage?
20                MR. COSTEDIO: All of those topics are 21 included -- we issue what we call Issue Management 22 Reports, which are contained in our Corrective Action 23 Program. And every one of them is being tracked to be 24 included in the operating license application.
25                COMMISSIONER BARAN: Okay, thank you.
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55 1                  Although      the    SHINE      facility  is    not    a 2 reactor,        part  of    the    licensing      basis  for      the 3 construction permit utilizes design principles from 4 the general design criteria for nuclear power plants.
5 Can you clarify the process you use to determine which 6 general design criteria are applicable to the SHINE 7 facility?
8                  MR. HENNESY:        We  reviewed    all    of    the 9 general design criteria as outlined in our PSAR when 10 we were looking at the preliminary design, and the 11 PSAR also contains a description of how each of those 12 GDC would apply to SHINE, or how it's integrated into 13 our design, so we actually reviewed all of them.
14                  COMMISSIONER BARAN: Okay. So, you went 15 through them all systematically and assessed whether 16 each one would apply in concept at least to this 17 facility.
18                  MR. HENNESY: Yes.
19                  COMMISSIONER BARAN: Okay, thank you. Thank 20 you, Mr. Chairman.
21                  CHAIRMAN BURNS: Thank you, Commissioner.
22                  I want to thank the Applicant's panel for 23 their        presentations.      We'll      now    proceed  with      the 24 Overview Panel from the NRC Staff. I'll ask the 25 witnesses please come forward, yes.
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56 1                  Okay. Again, this will be the Overview 2 Panel, or an overview from the Staff Panel with 3 respect to the application. I'm going to remind the 4 witnesses you're under oath, and did you all take the 5 oath?
6                  WITNESSES: Yes, sir.
7                  CHAIRMAN BURNS: Okay. And, again, assume 8 that the Commission is familiar, generally familiar 9 with the pre-hearing filings from the Staff and the 10 Applicant. And I will ask the panelists to introduce 11 themselves. Ms. Gavrilas.
12                  MS. GAVRILAS: Mirela Gavrilas, Division of 13 Policy and Rulemaking in NRR.
14                  MS. MARSHALL:        Jane      Marshall. I'm      the 15 Deputy Director for the Division of License Renewal in 16 NRR.
17                  MR. DEAN: Bill Dean, Director of Office of 18 Nuclear Reactor Regulation.
19                  MS. BAILEY:        Marissa        Bailey. I'm      the 20 Director      for  the    Division        of    Fuel  Cycle    Safety 21 Safeguards and Environmental Review in NMSS.
22                  CHAIRMAN BURNS: Okay, thank you. And let 23 the Staff proceed.
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57 1 morning        to provide      testimony        associated with      the 2 application for a construction permit submitted by 3 SHINE Medical Technologies for a medical radioisotope 4 irradiation and production facility.
5                  What you'll hear from this panel is an 6 overview of the Staff's review methodology, as well as 7 highlighting some of the technical and environmental 8 review aspects of it. Essentially, we'll be setting 9 the stage for the panels that you'll have later today 10 on both the technical and environmental aspects of the 11 review. Go to the next slide, please.
12                  So, I'm not going to spend much time on 13 this slide. I think the SHINE representatives did a 14 very good job in terms of setting the stage for the 15 importance of moly-99 production, benefits of the 16 technetium-99m stable as an important radioisotope for 17 medical diagnostic procedures. I think they also set 18 the stage in terms of how much this radioisotope is 19 used in both the United States and globally, so I 20 think they set a pretty good stage for why it's 21 important that we pursue domestic supply, particularly 22 with the Canadian facility scheduled to shut down in 23 2018, as well as the challenges that have existed at 24 some of the foreign facilities with interruptions in 25 supply because of extensive shutdowns for maintenance NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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58 1 activities and so on. So, I think we have a pretty 2 good case for why it's important domestically that we 3 have      a  moly-99  production        facility.      Next    slide, 4 please.
5                  So,  national        policy        objectives      which 6 support domestic production capabilities really have 7 three major components to them. One is to assure that 8 we have a reliable source of moly-99 production.
9 Secondly, that it's not utilizing highly enriched 10 uranium in producing the moly-99, as well as no market 11 subsidies. Those are three aspects of the national 12 objectives        associated        with      moly-99      production 13 domestically.
14                  We  have      --    DOE's        National    Security 15 Administration has engaged in cost-sharing agreements 16 with        various    organizations,            and    SHINE    Medical 17 Technologies is one of those in terms of helping to 18 develop moly-99 production capability. As the SHINE 19 representatives        noted,      they    plan      on  utilizing        a 20 uranium fission process utilizing low enriched uranium 21 in an aqueous homogeneous reactor, and then chemically 22 separating the moly-99 in a radioisotope production 23 facility.
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59 1 with the national policy, and conforms with the Atomic 2 Energy Act, and all the applicable regulations. Next 3 slide, please.
4                We've been preparing for the SHINE review, 5 and      actually  review      of    any    medical radioisotope 6 facility for some time. Back in 2009, we formed an 7 interoffice working group that contributed substantial 8 technical and regulatory diversity and expertise in 9 terms of developing approaches that we would consider 10 if and when we got a production facility application.
11                Back in 2012, we created a Interim Staff 12 Guidance document that was specifically focused on 13 aqueous homogeneous reactors to support and supplement 14 the SRP or the Standard Review Plan for research and 15 test reactors. And this is the products that the SHINE 16 facilities have utilized in terms of developing their 17 construction application.
18                We've had a number of public meetings with 19 engaged stakeholders. This includes, obviously, the 20 SHINE management and staff, public individuals, as 21 well as federal, state, and local governments. These 22 meetings have been focused on the technical, the 23 regulatory, and the environmental review aspects of 24 the SHINE facility. We also have coordinated our 25 review with federal, state, and local governments. So, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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60 1 for example, NMSA from DOE has been involved, the 2 Environmental Protection Agency, the National Fish and 3 Wildlife        Foundation,      and    the    Advisory    Council      on 4 Historical Preservation. And at the state and local 5 levels, the State of Wisconsin Department of Health 6 Services, and the Janesville City Council has been 7 significantly involved with us in terms of some of the 8 review aspects. Next slide, please.
9                    So, at this point I'd like to turn it over 10 to Mirela who will discuss the Staff's review of the 11 SHINE construction permit.
12                    MS. GAVRILAS: Thank you, Bill.
13                    In  2013,      SHINE    submitted      a  two-part 14 application for a construction permit under 10 CFR 15 Part 50. If granted, the permit will allow SHINE to 16 construct a medical radioisotope production facility 17 in Janesville, Wisconsin. SHINE's application only 18 seeks authorization to construct the proposed SHINE 19 facility; therefore, the 10 CFR Part 50 regulations 20 require less detail than for an operating license or 21 a Combined License application.
22                    The necessary elements of a construction 23 permit application are provided in Section 5034 and 24 include        a  preliminary      design      of    the  facility,      a 25 preliminary        analysis      of    structures,        systems,      and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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61 1 components,      probable          subjects        of    technical 2 specifications,      a    preliminary          emergency    plan,      a 3 quality assurance program, and ongoing research and 4 development.
5                SHINE    will      submit      the  Final    Safety 6 Analysis Report or FSAR with their operating license.
7 The FSAR will include SHINE's final design, plans for 8 operation, emergency plan, technical specification, 9 and physical security plan. Next slide, please.
10                The    Staff's        evaluation        of  SHINE's 11 construction    permit      application          consisted  of    two 12 concurrent reviews. One, of SHINE's Preliminary Safety 13 Analysis Report, or PSAR, and the other of SHINE's 14 environmental    report.      I    will    discuss    the  Staff's 15 safety review, and Jane Marshall will discuss the 16 Staff's environmental review.
17                The Staff's safety review assessed the 18 sufficiency of the preliminary design. This includes 19 the principal design criteria and the design basis of 20 SHINE's proposed medical radioisotope facility. The 21 SHINE facility consists of an irradiation facility, or 22 IF, and a Radioisotope Production Facility, or RPF.
23 Next slide, please.
24                From  the    Staff's      perspective,      SHINE's 25 irradiation    facility      and    radioisotope        production NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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62 1 facility      rely    on    novel      and      unique    technology.
2 Therefore,      the  Staff    tailored        its  activities      and 3 coordinated with offices throughout the Agency to 4 insure an informed and efficient review.
5                  SHINE's irradiation facility consists of 6 eight subcritical operating assemblies or irradiation 7 units. Each irradiation unit is a 10 CFR Part 50 8 utilization facility. While not reactors, irradiation 9 units are similar to research reactors.
10                  SHINE's proposed radioisotope production 11 facility      consists    of  three      super    cells  for      the 12 separation of molybdenum-99 from irradiated target 13 solution. The RFP is a 10 CFR Part 50 production 14 facility. However, the RFP has physical and chemical 15 processes similar to existing fuel cycle facilities.
16 For both the irradiation facility and the radioisotope 17 production facility, the Staff used the Commission's 18 regulations        and    existing      guidance      to  determine 19 acceptance criteria that demonstrate compliance with 20 regulatory requirements.
21                  The Staff's safety evaluation for both the 22 irradiation facility and the radioisotope production 23 facility was informed primarily by NUREG-1537 which is 24 the      Standard    Review    Plan    for      research  and    test 25 reactors. The Staff augmented NUREG-1537 with Interim NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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63 1 Staff        Guidance    or    ISG    for      evaluating  aqueous 2 homogenous systems and production facilities. The 3 Staff also assessed the preliminary design to have 4 reasonable assurance that SHINE's final design will 5 conform to the design basis. Next slide, please.
6                    An important part of the Staff's review 7 was to determine what additional technical and design 8 information beyond SHINE's initial PSAR was necessary 9 to support the evaluation of the construction permit 10 application. The Staff issued Requests for Additional 11 Information and SHINE supplemented its application.
12                    After    reviewing        the    application        as 13 supplemented, the Staff found that SHINE provided all 14 the information necessary for the Staff to complete 15 its safety review for the purposes of issuing a 16 construction permit. However, the Staff identified 17 certain areas where additional information is required 18 before construction is complete. The Staff is, thus, 19 recommending construction permit conditions.
20                    The conditions require SHINE to provide 21 periodic updates on the design of certain features 22 related        to    criticality          safety      and  radiation 23 protection. These updates are consistent with 10 CFR 24 50.35. They are intended to confirm that SHINE's final 25 design will conform to the PSAR design basis. For NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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64 1 example, SHINE has proposed a criticality alarm system 2 in the radioisotope production facility. A shielding 3 wall will surround the criticality alarm system. The 4 Staff believes that before construction is complete, 5 SHINE must establish the appropriate shielding wall's 6 thickness because if the shielding is too thick, the 7 alarm system will not perform as required. If the 8 shielding is too think, radiation protection will 9 become a concern.
10                  In instances where additional information 11 may reasonably be left for later consideration, SHINE 12 has made commitments to provide such information in 13 the FSAR. These commitments are listed in Appendix A 14 of the Safety Evaluation Report, or SER. The Staff 15 will      verify  that    necessary        information    has    been 16 provided      during    the    review      of    SHINE's operating 17 license application.
18                  The Staff's SER also initially proposed 19 conditions        related      to    the    Preliminary    Amendment 20 Request process. However, as noted in our answers to 21 pre-hearing questions, the Staff has determined that 22 this process is better suited for construction based 23 on a final facility design. As such, the Staff no 24 longer recommends these conditions. The Staff finds 25 that      the  existing      regulations        in  10 CFR  50    are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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65 1 sufficient        to    accommodate        changes      to  the    SHINE 2 facility as the design matures. Next slide, please.
3                  I will now turn over the presentation to 4 Jane        Marshall    for      an    overview        of    the    SHINE 5 environmental review.
6                  MS. MARSHALL: Thank you, Mirela.
7                  The environmental review for the SHINE 8 construction        permit      application          was  performed        in 9 accordance with the National Environmental Policy Act 10 of      1969,    commonly        referred        to    as    NEPA.      NEPA 11 established        a    national        policy        for    considering 12 environmental impacts and requires federal agencies to 13 follow a systematic approach in evaluating potential 14 impacts, and to assess alternatives to the proposed 15 action.        The  NEPA      process      also      involves      public 16 participation and public disclosure.
17                  10    CFR      Part      51      contains        NRC's 18 environmental regulations which implement NEPA. These 19 regulations describe when the Staff should prepare an 20 Environmental        Impact      Statement        or  EIS. The    NRC's 21 regulations did not require the preparation of an EIS 22 for SHINE's application; however, the Staff determined 23 that an EIS would be appropriate because SHINE is a 24 first-of-a-kind application for medical radioisotope 25 production        facility      with    a  unique      application        of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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66 1 technologies      and    an    EIS    would        allow  several 2 opportunities      for      public      involvement        in      the 3 environmental review process.
4                Ultimately,          the        purpose      of        the 5 environmental review is to identify the environmental 6 impacts        of    constructing,                operating,        and 7 decommissioning the proposed SHINE facility, as well 8 as      alternatives    to    the    SHINE      facility,    and      in 9 combination with the safety review inform the Staff's 10 recommendation to the Commission whether or not to 11 issue the construction permit. Next slide, please.
12                The Staff began the environmental review 13 with a scoping process to gather input from the 14 public, other government agencies, and tribes on the 15 necessary scope for the EIS. The Staff conducted an 16 Environmental Site Audit to view the environmental 17 features at the proposed site and the alternative 18 sites, and met with SHINE's technical specialists that 19 developed the environmental report. The Staff also 20 developed      Requests    for    Additional        Information        to 21 clarify aspects of SHINE's environmental report and to 22 seek additional information not included in SHINE's 23 environmental report.
24                The Staff developed a Draft EIS based on 25 the Staff's independent review, information in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1 environmental report, answers to the Staff's Request 2 for Additional Information, and input received during 3 the scoping process and Environmental Site Audit. The 4 Draft EIS was published for comment in May of 2015.
5 The Staff responded to all comments received in the 6 Final EIS which was published in October 2015. The 7 Staff also updated the Final EIS based on in-scope 8 comments and newly available information. Next slide, 9 please.
10                  The    proposed        site      is  currently        an 11 agricultural field which has been previously disturbed 12 from      decades    of  agricultural          activities,    and      is 13 currently zoned for light industrial use. The proposed 14 site does not contain any surface water features, 15 threatened or endangered or candidate species, or 16 historical or cultural resources. The Staff determined 17 that the impacts to all resource areas except for 18 traffic would be small. The impacts to traffic would 19 be      small    to  moderate      because        of  the noticeable 20 increase in average daily traffic flow. Next slide, 21 please.
22                  I will now turn the presentation over to 23 Marissa        Bailey  to  discuss      the      Staff's regulatory 24 findings supporting its recommendation that SHINE be 25 issued a construction permit.
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68 1                  MS. BAILEY: Thank you, Jane. And I'm on 2 Slide 13, and as Jane mentioned, I'll be discussing 3 the      Staff's  findings      to    support      issuance    of    a 4 construction permit.
5                  Section    103    of  the    Atomic  Energy      Act 6 authorizes        the  Commission        to    issue  licenses      to 7 utilization and production facilities subject to the 8 Commission's regulations. The principal regulatory 9 requirements for utilization and production facilities 10 are in 10 CFR Part 50.
11                  After completing the environmental and 12 safety reviews, the Staff has determined that SHINE's 13 application met the applicable requirements of 10 CFR 14 Parts 320, 50, and 51. Also, because processes and 15 hazards are similar to fuel cycle facilities, the 16 Staff determined the performance requirements in 10 17 CFR 70.61 can be used to demonstrate adequate safety 18 for the radioisotope production facility. Slide 14, 19 please.
20                  The  Staff's      review      supports  the    four 21 findings      in  10    CFR    50.35      for    issuance    of      a 22 construction permit. The first finding is that the 23 Applicant has described the proposed design of the 24 facility. The Staff used 10 CFR 50.34(a) and our 25 guidance      to    evaluate        the    sufficiency      of      the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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69 1 preliminary design making sure that SHINE's proposed 2 design basis and criteria are consistent with policy 3 regulations and guidance.
4                  SHINE committed to design the facility to 5 meet the operational safety requirements in 10 CFR 6 Part 20, and the accident consequence and likelihood 7 criteria in the Interim Staff Guidance augmenting 8 NUREG-1537.          SHINE        designated          safety-related 9 structures,        systems,      and    components      that  will      be 10 provided for the protection of the health and safety 11 of the public.
12                  The second finding is that the Applicant 13 has identified technical or design information that 14 can be reasonably left for the Final Safety Analysis 15 Report.        The  Preliminary        Safety      Analysis    Report 16 identified        such  information.            This  includes      the 17 security        and    safety      emergency          plans,  facility 18 operating procedures, and certain design information 19 that SHINE committed to provide in the Final Safety 20 Analysis Report.
21                  The third finding is that the Applicant 22 has identified safety features that required further 23 research and development, and SHINE has done that.
24 SHINE has ongoing research and development activities 25 related to irradiation and corrosion testing, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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70 1 precipitation studies. These tests are being performed 2 by      Oak    Ridge  and    Argonne      National      Laboratories 3 respectively.
4                    The fourth finding is, one, for those 5 safety questions and SHINE's research programs, Staff 6 has reasonable assurance that SHINE will be able to 7 complete the research programs before the latest date 8 of construction. And, two, taking into consideration 9 the site criteria contained in 10 CFR Part 100, the 10 proposed facility can be constructed and operated 11 without undue risk to the public. And with respect to 12 that fourth finding, SHINE stated that the latest date 13 of their construction would be December 31, 2022.
14 Based on the schedule SHINE has given us, we're 15 expecting that the research programs will be completed 16 before        this  date.      Also,    the      additional    permit 17 conditions related to criticality safety and radiation 18 safety must be satisfied before the completion of 19 construction.
20                    The site criterion Part 100 applied to 21 power reactors and testing facilities, and not to 22 SHINE's,        but  the    Staff      considered      similar    site-23 specific conditions and external events. The Staff's 24 review confirmed that the radiological releases during 25 normal and abnormal conditions will be within the 10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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71 1 CFR Part 20 dose limits. Thus, we find that the 2 proposed facility can be constructed and operated at 3 the proposed location without undue risk to the health 4 and safety of the public.
5                    Additionally, the Staff concludes that for 6 the purpose of issuing a construction permit, it 7 conducted a thorough and complete environmental review 8 sufficient        to  meet    the    requirements        of  NEPA      and 9 adequate to inform the Commission's action on the 10 construction permit request. Slide 15, please.
11                    Based    on    these      findings,      the    Staff 12 concludes that there is sufficient information for the 13 Commission to issue the subject construction permit to 14 SHINE as guided by the following considerations in 10 15 CFR      50.40    and  50.50. First,      there      is  reasonable 16 assurance that the construction of the SHINE facility 17 will not endanger the health and safety of the public, 18 and that construction activities can be conducted in 19 compliance with the Commission's regulations.
20                    Second,      SHINE        is      technically        and 21 financially qualified to engage in the construction of 22 its      proposed      facility.      Third,      the    issuance      of    a 23 construction permit for the facility would not be 24 inimical to the common defense and security, or to the 25 health        and  safety    of  the      public.      Fourth,    after NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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72 1 weighing the environmental, economic, technical and 2 other benefits of the facility against environmental 3 and other costs and considering reasonable available 4 alternatives, the issuance of this construction permit 5 is in accordance with Subpart A of 10 CFR Part 51, and 6 all applicable requirements have been satisfied. And 7 fifth,        the  application        meets      the  standards      and 8 requirements          of    the    Atomic      Energy    Act  and      the 9 Commission's regulations, and that notifications to 10 other agencies or bodies have been duly made. Slide 11 16, please.
12                    The Staff will discuss novel aspects of 13 its        review    of    the    SHINE      construction      permit 14 application. Safety Panel 1 will discuss the unique 15 licensing considerations. Safety Panel 2 will follow 16 with details of the Staff's accident analysis. And, 17 finally,        the  Environmental          Panel    will  provide      a 18 summary          of    the      process        for      developing        the 19 Environmental Impact Statement.
20                    This concludes the Staff's remarks in the 21 Overview Panel. We're prepared to respond to any 22 questions you may have at this time. Thank you.
23                    CHAIRMAN BURNS: Okay. I want to thank the 24 Staff Panel. We'll begin this round of questioning 25 with Commissioner Svinicki.
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73 1                    COMMISSIONER SVINICKI: Well, good morning, 2 and thank you to the NRC Staff witnesses, and all the 3 NRC Staff that contributed to the review which is the 4 topic of our evaluation and consideration here today.
5                    I should have been born in Missouri, I 6 guess, because I'm the kind of person that I don't 7 really judge things by what people tell me they're 8 capable of, or what they say they plan to do, but what 9 they actually perform, how they actually perform, and 10 what they actually do. You know, the Chairman was 11 talking in his opening remarks about some of the 12 significant licensing work that the NRC Staff has 13 undertaken this year. We've had a number of mandatory 14 hearings, and there are many tens of thousands of NRC 15 Staff        hours  that    go  into      that      review, not    just 16 licensing        staff,    but    legal,      and    a  lot of    other 17 support, organization support that work.
18                    I think if we look at, in particular, 19 Watts Bar 2 operating license and in the Staff's work 20 in support of the findings they've made for issuance 21 of this construction permit, it's an interesting thing 22 has happened. And, again, I -- you know, these days 23 with the news such as it is, I'll turn over every rock 24 and look for some good news, so you can fault me for 25 that, if you want. But there are many questions being NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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74 1 asked about the NRC's potential readiness to look at 2 novel reactor technologies. And I think if we looked 3 at the kind of work and adaptation and agility that 4 had to be demonstrated in the Watts Bar 2 history 5 which had a very unique history in terms of the run-6 up, the many decades run-up to the issuance of that 7 operating license. And then if we complement that with 8 the      Staff's  work    here      in    looking  at the    SHINE 9 construction permit application, but ultimately, also, 10 you're looking forward towards the operating phase and 11 making the safety and environmental determinations 12 that you will need to make there.
13                  I  think      it    demonstrates    to      those 14 skeptical, or maybe those who feel that the NRC's 15 approach and regulations and guidance indicates a very 16 linear and rigid approach to licensing new and novel 17 things. I think both of those licensing activities 18 demonstrated significant ability to take a regulatory 19 framework, existing guidance, maybe complemented by 20 some new Interim Staff Guidance and take that and kind 21 of wrap it around the thing that's in front of you and 22 say what are the relevant and appropriate parts, and 23 how do we do that? And, often, you haven't taken years 24 and years worth of trying to develop the little bits 25 that you need to augment support.
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75 1                  Mr. Dean did mention that the Staff has 2 been        preparing    itself      for      a    medical  isotope 3 application, but the truth of the matter is, it could 4 have taken a lot of different forms. There's -- it 5 could have been vastly different, so what the Staff 6 needed to have in place is something that they could 7 innovate and adapt, and tailor to the thing in front 8 of it. And I think, at least to this stage of the 9 process, and there are quite a few issues, might get 10 a    little    tricker    in  the    operating      license    phase 11 because you've got to come to finality on some complex 12 issues. But that being said, the reason I asked the 13 Applicant in the Overview Panel about getting some 14 calibration on their view of regulatory uncertainty is 15 that when you're inside NRC, you often walk around --
16  we walk around with greater familiarity, perhaps, 17 with the regulatory system, but maybe as a result, a 18 greater confidence in the ability to on our feet do 19 adaptation and innovation, and tailor that particular 20 regulatory framework to whatever is presented to us 21 for review and approval. And I think that we've done 22 that here.
23                  So, having asked the Applicant how did 24 this adaptive process work from their standpoint, I 25 think I got a fairly positive response on that. How NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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76 1 would the Staff answer that same question? Do you 2 think        that  this    taking      the      existing  regulatory 3 framework guidance and then adapting it, determining 4 relevance of various provisions within the framework, 5 do you think that that worked well to this stage, and 6 is    your    confidence      high    that      that will  continue 7 through the remainder of the review? Again, where you 8 will be required to meet the higher bar of coming to 9 closure and finality on some open issues that right 10 now you can, in essence, to use a bad word, punt those 11 off to the operating license stage.
12                  MR. DEAN: So, thank you for the remarks, 13 Commissioner. And I would agree with you, I think the 14 Staff has shown a high degree of flexibility and 15 agility in terms of how they have managed this review 16 activity.
17                  I think one of the important things for 18 us, and maybe Mirela can add something to this, is 19 having a sense of commitment on the part of the 20 Applicant, so that it was worthwhile to invest what we 21 needed to do in order to be at the stage that we're at 22 to be able to conduct the review. I think having some 23 predictability and confidence in that certainly helps 24 us move forward in a way that would allow us to apply 25 all the resources that we did. For example, to develop NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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77 1 the ISG on the aqueous homogenous reactor, I think was 2 an important development given the fact that we had 3 confidence      that  there      would      be    something    coming 4 forward from SHINE. Mirela, do you have anything to 5 add?
6                MS. GAVRILAS: Yes. I can add to that, and 7 I certainly agree what Bill said, that having the 8 interactions with SHINE throughout the process through 9 public meeting was very helpful. But getting back to 10 your original statement, indeed, the Staff does have 11 some confidence in the regulatory framework, and that 12 starts with we know that Part 50 is applicable to 13 irradiation facilities and to production facilities.
14 We know that the irradiation facilities, while they're 15 indeed novel to us, they look like our research 16 reactors, and we have experience with a spectrum of 17 research reactors that exhibit a lot of variability.
18 We have experience with -- I think just before this 19 meeting I was told 12 homogeneous aqueous research 20 reactors,      so  even    there      we    have    the  experience 21 necessary.
22                On the side of the production facility, we 23 have experience with Cintichem. Granted, that was 24 under Part 70, but we have the West Valley facility 25 that was actually licensed under Part 50. So, what the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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78 1 Staff did is, we took the guidance that we had for 2 these -- for research and test reactor, the NUREG-1537 3 which is our Standard Review Plan, augmented it with 4 ISG that captured liquid homogeneous reactors, and the 5 production facilities and came up with a framework 6 that was suitable for SHINE.
7                COMMISSIONER SVINICKI: To build on that, 8 and this is my final question. Maybe this will be a 9 little tricky, so bear with me. Would the Staff assert 10 that the decisions that you've made to this point on 11 which portions and provisions within those portions of 12 our regulations are relevant to your review of this 13 technology      on    the      safety        side?    Are      those 14 determinations you think final, or subject to change?
15 I guess what I'm asking is, as you move towards 16 closure in areas that you or the ACRS has suggested 17 bear additional work, criticality comes to mind, other 18 things where we have to adapt the framework to the 19 highly novel aspects of what we're looking at and make 20 a final safety determination. Do you think you might 21 determine that some section of the CFR that you 22 previously    just    weren't      even      engaging  with      the 23 Applicant on, you might suddenly go, you know, we 24 didn't really look there earlier, but based on the 25 path that this technical issue is taking, we now think NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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79 1 that some new provision of the regulation, you're 2 going to have to demonstrate that you meet some 3 requirement there. Do you think that that's likely or 4 unlikely?
5                MS. GAVRILAS: I can try to answer that, 6 and      maybe  I'll  need    help      on    that. So,  for      the 7 construction permit we feel we're done, so basically 8 there's nothing that is needed. Looking forward to the 9 operating      license,    that's      going      to be  our    first 10 priority, to look at the regulations and see what, if 11 anything,      will  need      to    be    adapted,    be    it      by 12 rulemaking, by order, licensing conditions. We're 13 going to think what's best for the framework to be 14 able to accommodate the operating license review. And 15 we already know that there are some things that impact 16 moly production facilities. For example, the work on 17 material characterization under 74, the rulemaking 18 there is going to be relevant to moly producers.
19 There's security work under Part 73 that's going to be 20 relevant to them. We know that we'll need to look 21 closely at operator licensing because operators might 22 be needed not just for the utilization facility, but 23 also for the production facility, so we'll need to 24 scrutinize the regulation. So, we know we have some 25 work to do going forward.
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80 1                    As  far      as    your      question    for      the 2 technology, we haven't necessarily seen something in 3 the regulation that might need to be changed. It's 4 more the administrative procedural, not the technology 5 itself that is worrying us right now going forward.
6                    COMMISSIONER SVINICKI: I need to ask a 7 follow-up based on that answer. Thank you for that 8 answer.
9                    If we look at the broad purposes of why an 10 agency such as our's reviews and issues a construction 11 permit, there is an element of wanting to identify 12 issues so that irreversible or very difficult to 13 reverse decisions are not made in the construction of 14 the facility; that, you know, you want some sense of, 15 if constructed in accordance with the construction 16 permit that we would issue, there would be high 17 confidence that if other issues are resolved you could 18 operate that facility at some point without needing to 19 chip      out  a  4-foot      thick    concrete      wall  and      make 20 fundamental changes. So, what is the Staff's level of 21 confidence in terms of the identification of relevant 22 regulations that you just described in your previous 23 answer?        Do  you  think    that      that      lends  additional 24 uncertainty        going    forward      to    the    probability        of 25 successful issuance of an operating license in terms NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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81 1 of physical rework of what it is that they're going to 2 construct? I know the potential always exists. I'm not 3 asking you if it's zero. I'm asking you, you know, do 4 you      have    like    at    least    a    reasonable      sense      of 5 confidence that you've identified issues that have the 6 potential for causing substantial rework?
7                    MS. GAVRILAS: So, perhaps what would help 8 is an example on where we set the bar for what's 9 sufficient for construction permit, as opposed to what 10 the expectation is for an operating license. And the 11 bar was, we heard SHINE speak earlier about hydrogen 12 control. So, hydrogen control is a perfect example, 13 because        the  physics.      In    other        words,  what      the 14 concentrations          are    where    deflagration        becomes      a 15 concern are known. The production rate of hydrogen is 16 known.        Our    models,      we    have        well    established 17 uncertainties in those models. We can bound them.
18                    Furthermore,          what's        also  known        is 19 mitigation technology for that. For example, passive 20 autocatalytic recombiners, I think SHINE mentioned 21 those, igniters. There's technology to mitigate the 22 broad range of hydrogen production, so we know that.
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82 1 to us on what they intend to use, we have confidence 2 that        the  outstanding        technical        issues  have      a 3 reasonable chance of being addressed.
4                  COMMISSIONER SVINICKI: Okay. So based on 5 that, is it fair to characterize that the Staff at 6 this stage has not recommended anything in terms of 7 going forward with the construction permit that it 8 would        identify  as    fundamentally          unlicensable      or 9 unlikely to be able to be operated or licensed at the 10 operating license stage?
11                  MS. GAVRILAS: That's fair.
12                  COMMISSIONER SVINICKI: Okay, thank you.
13 Thank you, Mr. Chairman.
14                  CHAIRMAN BURNS: Thank you, Commissioner.
15 Commissioner Ostendorff.
16                  COMMISSIONER          OSTENDORFF:      Thank      you, 17 Chairman. Thank you all for your briefs today, and for 18 the work of you and your teams. It's important work.
19                  I want to maybe, Mirela, pick up a little 20 bit with where Commissioner Svinicki was probing with 21 you. From your Slide 8 where you said the Staff used 22 existing guidance in the discussions with Commissioner 23 Svinicki and the exchange during her Q & A, I just 24 want to make sure I understand one thing. I think it 25 is that you did not -- you and your team did not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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83 1 experience any challenges working within our existing 2 regulations with our existing guidance as far as being 3 able to I'll say on the fly adapt where judgment would 4 lead one to say this is a reasonable way of handling 5 a particular design issue.
6                  MS. GAVRILAS: No, the challenges as I --
7  in my earlier answer, the challenge is where the bar 8 for construction permit needs to be set relative to 9 what our expectations are in the final design. That 10 was where the Staff needed to exercise its technical 11 judgment. We haven't had areas where we needed to --
12    where we had significant gaps that we needed to 13 address, if I understood your question correctly. If 14 I didn't --
15                  COMMISSIONER OSTENDORFF: Let me rephrase 16 it because I'm not sure -- I may not have asked it as 17 clearly as I should have.
18                  Were there flaws or gaps in the existing 19 NRC regulations or guidance that prevented your team 20 from doing their work on the construction permit?
21                  MS. GAVRILAS: There was one issue that we 22 had      to    address,    specifically          the  fact that      the 23 irradiation facility was not covered under Part 50 24 because they're subcritical and the definition for 25 irradiation facility --
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84 1                  COMMISSIONER OSTENDORFF: I understand. The 2 Commission got involved in that here.
3                  MS. GAVRILAS: Yes, that's the only flaw 4 that we found.
5                  COMMISSIONER OSTENDORFF: Okay. And you 6 felt like the -- working within the existing guidance 7 documents that there was sufficient flexibility for 8 the Staff to be able to exercise reasonable judgment 9 as to how to apply certain sections?
10                  MS. GAVRILAS: Yes. And that might be aided 11 by the fact that the existing guidance that we relied 12 upon was primarily NUREG-1537, which is designed for 13 research reactors which do exhibit a fair amount of --
14                  COMMISSIONER OSTENDORFF: Okay.
15                  MS. GAVRILAS:        -- differences.
16                  COMMISSIONER OSTENDORFF: Okay. I think 17 this is still a question for you, but others may want 18 to chime in here. The first session with the SHINE 19 panel, I asked a question that was addressed I think 20 by      Eric  about  the    use    of    prototypes    by    SHINE 21 organization,        the      reference        to  other  existing 22 reactors, and I think Eric mentioned one from the Los 23 Alamos National Laboratory. Can you talk at a high 24 level about how our Staff perhaps used experience of 25 these prototypes or other existing technologies to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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85 1 consider the construction permit?
2                  MS. GAVRILAS: I'm going to ask Steve Lynch 3 who was the Project Manager on SHINE to talk about 4 specifics.
5                  CHAIRMAN BURNS: Okay. And, Mr. Lynch, 6 identify yourself for the record, and confirm that you 7 took the oath.
8                  MR. LYNCH: Yes. My name is Steve Lynch. I 9 am the Project Manager for SHINE on the NRC Staff. And 10 yes, I did take the oath.
11                  CHAIRMAN BURNS: Okay, proceed.
12                  MR. LYNCH: Yes. As far as facilities most 13 we considered on the irradiation facility side were 14 existing research reactors and past experience with 15 aqueous        homogeneous      reactors.        On  the  production 16 facility side we did look back to our licensing 17 experience with the Cintichem facility. We actually 18 did have on staff former employees from Cintichem that 19 helped inform the development of our guidance and the 20 beginning of our review.
21                  COMMISSIONER        OSTENDORFF:      Can  you    talk 22 about, Steve, I think Eric had mentioned SHINE's own 23 prototype efforts. Can you talk about how you might 24 have looked at those, or considered those in your 25 review?
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86 1                  MR. LYNCH: We have not looked extensively 2 at the prototypes. We have considered some of the 3 papers that have come out from the National Labs 4 describing their results. We will look more carefully 5 at that at the operating license stage.
6                  COMMISSIONER OSTENDORFF: Okay, thank you.
7                  Jane, I don't want you to go without a 8 question here.
9                  MS. MARSHALL: Thank you, sir.
10                  COMMISSIONER        OSTENDORFF:        I'll  ask      an 11 environmental review question. And, you know, I think 12 Mirela has mentioned -- my question is what is this 13 like,        the environmental        review,      is  this  like      a 14 research test reactor, or is it like in Marissa's 15 bailiwick the fuel cycle facility? What is -- does the 16 environmental review look like? Is it a hybrid of 17 these, or something else?
18                  MS. MARSHALL: It's a hybrid. I guess we're 19 lucky in a sense. All of the environmental regulations 20 are in Part 51, so we didn't have to look beyond that.
21 And as part of the environmental review, we looked at 22 the      connected  action      so    we    didn't    just  look      at 23 construction, we looked at operation, decommissioning, 24 traffic flow. So, in that sense it was much like any 25 other environmental impact statement that we would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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87 1 prepare.
2                COMMISSIONER        OSTENDORFF:    Okay. Anybody 3 else on that? All right, thank you. Thank you all.
4                CHAIRMAN BURNS: Thank you, Commissioner.
5 Commissioner Baran.
6                COMMISSIONER BARAN: Thanks. Well, let me 7 start by thanking you and the rest of the Staff who 8 worked on this application for all the hard work that 9 went not only into preparing for today's hearing, but 10 also      all the  efforts      in    reviewing    this    unique 11 application.
12                I wanted to follow-up on a couple of 13 things I asked about -- asked SHINE about on the first 14 panel. Going back to the ACRS letter and the seven 15 topics that they identified that should be further 16 addressed in an application for an operating license.
17 We talked to SHINE about that. They said those are 18 going to be addressed in their Corrective Action 19 Program. Can you talk a little bit about how the Staff 20 intends to insure that those issues are addressed in 21 the operating license application?
22                MS. GAVRILAS: Some of the items that came 23 out of the ACRS discussions are actually captured in 24 our SER. They are among the items that we listed in 25 Appendix A. Perhaps it's not the complete list, but NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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88 1 we'll        make  sure    that      when    operating    review      --
2  operating license review time comes we will look at 3 the entirety of the items that were mentioned by the 4 ACRS in their letter.
5                  There were also commitments that SHINE 6 made      explicitly    to    the    ACRS,      and  those we    also 7 captured in the SER in the same Appendix A on the two 8 items that the ACRS had engaged them on, that the 9 Staff had not previously had discussions with them.
10 So, we fully intend to follow-up on all the items 11 raised by the ACRS.
12                  COMMISSIONER BARAN: Okay. And just to 13 clarify        then  for    the  answers        to  the pre-hearing 14 question related to this, some but not all of these 15 items the ACRS identified were captured as commitments 16 on Appendix A, in Appendix A.
17                  MS. GAVRILAS: I believe that is the case.
18 We'll check during the lunch break and we'll get back 19 to you at the end of the day, if we need to make a 20 correction on that.
21                  COMMISSIONER BARAN: Okay, great. Thanks.
22                  And as we've noted at various points, some 23 of the regulations, like the general design criteria, 24 don't apply to SHINE because it's not a reactor. But 25 the Staff considered these regulations when doing its NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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89 1 review, and the Applicant considered them in its 2 design. Can you describe that process in a little bit 3 more detail? Would the Staff ask RAIs on concept from 4 the general design criteria, or were these used as a 5 reference for the technical reviewers? What role did 6 they play?
7                MS. GAVRILAS: So, there's the expectation 8 in 50.34 of providing principal design criteria as 9 unambiguous, so we want that. What SHINE did in their 10 application, they actually came and had crosswalk 11 tables of all the 55 GDCs, how they apply or not 12 apply, or adapt to the features of their facility. So, 13 the Staff scrutinized that and found it acceptable.
14 And I will give an example for containment, GDC-16 15 deals with containment. They have a confinement, but 16 they adapted the notion of controlled leakage that's 17 intended in GDC-16. So, in addition to the GDCs, they 18 also have the GDCs, as you mentioned, are designed for 19 light water power reactor.
20                They also have a production facility that 21 has      unique  features.      There      they    proposed    safety 22 systems and components that actually lend themselves 23 to additional criteria. I'll give an example, the 24 concentration of uranium in the solution. That will 25 become part of the design basis. That is part of their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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90 1 design basis, and it's a design criteria for them.
2                  COMMISSIONER          BARAN:        Thanks,    that's 3 helpful.
4                  Bill, I have one question I think is 5 probably for you. And that has to do with how we're 6 going to oversee and inspect the SHINE facility during 7 construction if a construction permit is issued. Our 8 current construction inspectors have inspected against 9 the more detailed information provided in an operating 10 license. How would we insure that the inspectors are 11 prepared to inspect against a construction permit?
12                  MR. DEAN: So, I'll start and there may be 13 some      others  who  can    augment,        maybe  some  of    our 14 battalion of witnesses might want to chime in here.
15                  So, we'll be leveraging, obviously, the 16 construction inspection experience that we have in 17 Region II to support the construction activities.
18 Clearly,        we'll  need      to    develop      a  construction 19 inspection program much like we did for the Vogtle and 20 VC Summer units. So, we have a model there, obviously, 21 it's going to be scaled down, but I would expect that 22 what we would have would be a replica of a much 23 smaller        scale  as    to    what    we've      done  with      the 24 construction of the AP-1000s.
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91 1 done        significant    work      in    that      direction.      And, 2 actually, our Office of New Reactors worked with 3 Region II and, of course, with the rest of us, and 4 there is inspection procedures. And the lead on that 5 was Carl Weber, one of our witnesses, and he can talk 6 about the substance of that procedure.
7                  CHAIRMAN BURNS: Okay. Identify yourself, 8 and confirm you've been put under oath.
9                  MR. WEBER: My name is Carl Weber. I work 10 for the Office of New Reactors in the Construction 11 Inspection Branch. And I helped to develop the overall 12 inspection program for basically radioactive isotope 13 production. We didn't do a specific program just for 14 SHINE, we made it fairly generic. And what we did was 15 we went back and looked at similar -- programs with 16 similarities. For example, we looked at the Watts Bar 17 program where they were inspecting to a construction 18 permit. We also looked at the mixed oxide facilities, 19 and      we    looked  at    the    Louisiana      Energy  Services 20 programs. We got a group of people together who had 21 experience in this area, had a working group. We got 22 all their experience, and we developed the program 23 specifically for the radioactive isotope production.
24                  CHAIRMAN BURNS: Okay. And confirm you were 25 put under oath before.
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92 1                  MR. WEBER: Pardon me?
2                  CHAIRMAN BURNS: You did take the oath 3 before?
4                  MR. WEBER: Oh, yes. I'm sorry.
5                  CHAIRMAN BURNS: Okay, thanks.
6                  COMMISSIONER BARAN: Thank you very much.
7                  CHAIRMAN      BURNS:          I    appreciate        the 8 exploration        of    the      differences          in  terms        of 9 construction permit versus operating license that my 10 colleagues have done so far. A couple of questions I 11 had actually, you know, potentially looking forward.
12 In effect, what we actually have is eight production 13 facilities. Correct?
14                  MR. LYNCH:      Well,      there      will  be    eight 15 individual licenses.
16                  CHAIRMAN BURNS: Eight individual. Will 17 there be eight individual licenses --
18                  MS. GAVRILAS: Utilization facility.
19                  CHAIRMAN BURNS:          -- or is this -- would 20 the      intention  to    be  combined        into    one  operating 21 license?
22                  MS. GAVRILAS:        It's      eight    utilization 23 facilities, the irradiation facilities. And we're 24 looking at that. So, for example, just recently we 25 were      scanning  50.56    and    we  saw      one  construction NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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93 1 permit, one operating license, and then we gave some 2 thought to 50.52, that you can have activities from --
3  that you would license by themselves. You could have 4 them      all  under  one    license.        But    that's  all      our 5 thinking, it's preliminary. It will depend on what 6 SHINE applies for, and then we'll need to be more 7 rigorous in our considerations.
8                    CHAIRMAN BURNS: Okay. And a couple of 9 other questions. And, again, because we're adapting 10 this type of facility to the Part 50 framework, but 11 two others -- so, in this term have you looked down 12 the road as well, we're looking at license -- because 13 I heard someone mention licensed operators. So, we 14 think that's something that would be required or of 15 value as part of this facility licensing?
16                    MS. GAVRILAS: SHINE has, I believe, said 17 that they will have operators for the irradiation --
18    for      the  radioisotope        production        part  of    their 19 facility, so that we need to look into more detail 20 what provisions are in 50.55 for licensing operators, 21 if    there's    any  need    for    it.      So,  again,  this      is 22 exploratory.        They're      just      things      that  as    we're 23 reviewing the construction permit application are 24 coming to mind and we're jotting them down that we 25 need      to  explore    them    further        for  the  operating NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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94 1 license.
2                    CHAIRMAN BURNS: Okay. And I'll just put 3 one more on the plate there, because I saw in the -- I 4 was looking at the draft construction permit and it 5 speaks        to  the  financial        protection        and indemnity 6 requirements which are under Price-Anderson Act. And, 7 again, it's a Part 50 facility, so I mean looking at 8 the regulations, confirm under Part 140, Part 50 9 facility has those -- so, again, is that -- now, 10 again,        I  take  it    the  Staff      is      looking at    those 11 requirements under Price-Anderson to the extent that 12 they would apply. Obviously, this is not a large, you 13 know,        1,300  megawatt      or    1,000      megawatt  operating 14 plant, so there are different provisions, but I'm 15 presuming that's also something you need to resolve in 16 the longer term for the operating license.
17                    MS. GAVRILAS: I've noted your comment.
18                    CHAIRMAN BURNS: okay.
19                    MS. GAVRILAS: We haven't so far.
20                    CHAIRMAN      BURNS:      Okay.      Because    it      is 21 mentioned in the draft construction permit which is 22 what highlighted it to me.
23                    MS. GAVRILAS: Okay, then I'm probably 24 unaware of our discussions.
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95 1 also, in terms of one of the findings highlighted, one 2 of the findings was that the Applicant is technically 3 and      financially      qualified        for      purposes    of      the 4 construction permit. Can you give me a description of 5 what      the  Staff    did    with    respect        to  looking        at 6 financial qualifications for the construction permit?
7                    MS. GAVRILAS: At a very high level, we 8 basically scrutinized the funds that they have from 9 private investors. We also know that they are funded 10 by the Department of Energy, and we found that to be 11 sufficient for the purpose of construction permit.
12                    CHAIRMAN BURNS: Okay, thanks.
13                    There is a distinction, I think, made on 14 one of the slides between conditions in -- I think 15 it's on Slide 9. The slide says, "In some cases permit 16 conditions are necessary. In other circumstances" --
17  then the next bullet says, "Regulatory commitments 18 track        items  for    resolution        in    the    Final    Safety 19 Analysis Report or FSAR."
20                    Can the Staff give me a distinction, what 21 elevates itself to a condition versus a commitment 22 that somehow is tracked and how do you track those 23 commitments?
24                    MS. BAILEY:        The      conditions      in      the 25 construction permit are really associated with the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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96 1 criticality, radiological safety primarily for the 2 radioisotope production facility. Criticality safety, 3 that part of the facility is controlled primarily 4 through geometry and the configuration of design. As 5 SHINE mentioned earlier, the design is preliminary.
6 It's still under development, as well as the analysis 7 that goes with it. So, the permit conditions basically 8 allow the Staff to confirm as the design and the 9 evaluations of the design progress that it's being 10 done in accordance with the design criteria that's 11 described in the Preliminary Safety Analysis Report.
12                    What the conditions really do is it gives 13 us the assurance that SHINE will be able to provide 14 the necessary design and technical information in the 15 Final Safety Analysis Report for us to complete our 16 safety        evaluation.      So    part      of  that goes        to 17 Commissioner Svinicki's question about mitigating or 18 avoiding a rework of the facility once construction is 19 well underway or completed.
20                    CHAIRMAN BURNS: Okay. My final question 21 relates to the -- stated by the Staff, the Staff used 22 NUREG-1537 which has guidelines for preparation and 23 review of applications related to non-power reactors.
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97 1 prepared for evolving technologies that were not fully 2 developed and demonstrated at the time of publication.
3 What has been your experience with using this Interim 4 Staff Guidance? What do you think you've learned from 5 using it? Is it doing what you hoped it would do?
6                  MS. GAVRILAS: It is doing what we hoped it 7 would do. It met our purposes just fine for the 8 construction permit, and we anticipate that it will 9 continue to do so for the operating license. We found 10 one      fundamental  problem        with    the  guidance  as      we 11 developed it, and that had to do, we thought that the 12 irradiation facility was going to be able to be 13 reviewed as part of the production facility. That was 14 not the case for SHINE, for example. But other than 15 that,        the Interim    Staff      Guidance      works,  and      we 16 anticipated incorporating it into NUREG-1537 at the 17 next revision of the document.
18                  CHAIRMAN BURNS: Okay. And the reason I 19 want to make sure I understand; the two parts of the 20 facility could not be -- I'm trying -- you said they 21 could not be reviewed?
22                  MS. GAVRILAS: Yes, we initially --
23                  CHAIRMAN BURNS: Explain that.
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98 1 that      the  irradiation      facility        and  the  production 2 facility can be treated as one entity. And then when 3 we saw the SHINE application and we started giving 4 more      thought,    we  realized        that      they're  actually 5 distinct and they deserve to be -- they need to be 6 examined separately.
7                  CHAIRMAN BURNS: But examined separately in 8 what        sense,  that      the    regulatory        footprint        is 9 different? Again, I think of a large power reactor 10 that has a number -- it has a reactor, it has a number 11 of other buildings that may support it. So, help me 12 along here.
13                  MR. DEAN: Can I -- let me just --
14                  MS. GAVRILAS: Yes.
15                  MR. DEAN: At a high level, I think if you 16 looked at the irradiation facility, that's more like 17 a research and test reactor. Right? Whereas, the 18 radioisotope production facility really has a lot more 19 commonality with a fuel cycle facility.
20                  CHAIRMAN BURNS: Okay.
21                  MR. DEAN: Chemical processes, so I think 22 that      kind  of  was    --  as    we    looked    at  the    SHINE 23 application, we realized we probably need to treat 24 them sort of independently because of that. I don't 25 know if, Marissa, you have anything you want to add in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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99 1 that regard?
2                    MS. BAILEY: I think that's pretty close.
3 I    think    it's  really      in    terms      of  what  are      the 4 applicable acceptance criteria for each type of the 5 facility.        So,  for    example,      for      the  radioisotope 6 production facility because it resembles a fuel cycle 7 facility        in  terms    of  processes          and  hazards,        we 8 determined that even though it's licensed under Part 9 50, we could use the performance objectives in Part 70 10 to make a determination of acceptability for safety.
11                    CHAIRMAN BURNS: Okay. But, ultimately, 12 this is all licensed ---
13                    MS. BAILEY: Under Part 50.
14                    CHAIRMAN BURNS: Under Part 50, and it's 15 all licensed -- there's not another licensing action 16 going        on. I  understand        that      the    criteria      are 17 different. We've sort of banged this into Part 50 for 18 the subcritical assemblies in those units, and you 19 have this other part which is more like something we 20 -- that NMSS would typically license. But the whole 21 thing is put together, ultimately, under this license.
22                    MS. GAVRILAS: That's right.
23                    MS. BAILEY: Yes.
24                    CHAIRMAN BURNS: Okay. All right, thank 25 you. Commissioner Svinicki.
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100 1                COMMISSIONER SVINICKI: Just a follow-up.
2 In response to the Chairman's question on Price-3 Anderson indemnification and the Staff's answer, that 4 engendered a very energetic sidebar between counsel 5 for the Staff. Catherine or Mitzi, was there anything 6 counsel for the Staff wanted to respond on that, or is 7 that just you were excited because when the Chairman 8 opens the CFR during the meeting, you know something 9 is going to happen. Right? Did you want to provide any 10 augmentation to the Staff's answer on that? You could 11 say no, it's fine. You don't have to. I'm not saying 12 explain yourselves. I'm just saying, did you want to 13 supplement their answer?
14                MS. YOUNG: Mitzi Young, counsel for the 15 NRC Staff. First of all, let me defend myself. We've 16 been animated through the whole hearing. Every time 17 you ask a question we're excited because in your 18 questions you ask the questions we practice with them 19 in part, so this has been exciting from a number of 20 respects. But in terms of Price-Anderson, that is part 21 of the review. I believe 140 talks about a certain 22 power level for reactors, and I think what SHINE did 23 in their application, and Steven Lynch is obviously 24 more conversant on this than myself. They looked at 25 comparable power thermal output to identify what level NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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101 1 of Price-Anderson protection they would need to the 2 extent that they're not receiving Special Nuclear 3 Material to get a construction permit. That assurance 4 is not needed now, but it would be part of the 5 operating license review.
6                Steve, was there anything you wanted to 7 add?
8                MR. LYNCH: That's it.
9                MS. YOUNG: Thank you.
10                CHAIRMAN BURNS: All right, thanks very 11 much, Mitzi.
12                MS. YOUNG: Thank you.
13                CHAIRMAN BURNS: Thanks, Commissioner.
14                With that, we'll take a brief break and 15 then resume with Safety Panel 1. So, try to be back in 16 your seats in about five or six minutes.
17                (Whereupon, the proceedings went off the 18 record at 11:05 a.m., and went back on the record at 19 11:15 a.m.)
20                CHAIRMAN BURNS:          We'll call the hearing 21 back to order. In this next session we'll have Safety 22 Panel 1 and we'll hear first from the Applicant, 23 SHINE. We'll immediately follow that with the staff's 24 presentation for Safety Panel 1 and then follow with 25 Commissioner questions.            And in general the topics NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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102 1 will cover the chapter 1 of the Safety Evaluation 2 Report with respect to the facility, and chapter 4, 3 irradiation unit and radioisotope production facility 4 description to address the licensing considerations 5 for      the    subcritical      utilization          facilities      and 6 production facility.
7                    So with that, we'll go to our first panel 8 from SHINE.          Mr. Hennesy and Mr. Van Abel are here, 9 but, Ms. Kolb, I'll ask you to introduce yourself.
10                    MS. KOLB: My name is Catherine Kolb. I'm 11 a    supervisor        in    engineering          for    SHINE  Medical 12 Technologies.
13                    CHAIRMAN BURNS:        Okay.      Thanks very much.
14 And again, assume that the Commission is generally 15 familiar with the prehearing filings, and I remind you 16 you're under oath.            And please proceed.
17                    MR. VAN ABEL:          All right.        Good morning 18 again.        In this presentation I'd like to give a brief 19 continuing discussion on the facility.
20                    If we'd go to the next slide, slide 2.
21 Here again is the overall facility process overview.
22 We went through this in some detail in the overview 23 discussion.          I'm going to add a little additional 24 detail on the design requirements for these SSCs in 25 this presentation, but of course if we have any other NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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103 1 questions on the overall facility design, happy to 2 answer those as well.
3                    Next    slide,      please.          For  the    SHINE 4 facility certain SSCs are designated as safety-related 5 in our facility because they are relied upon to 6 perform        safety    functions        either        during    normal 7 operations or during design-basis events.                      And those 8 SSCs that are required to perform safety functions are 9 required        to  perform      those      in      the    environmental 10 conditions of normal operation and any accidents in 11 which they are required to function.                      For those SSCs 12 that      have  safety      significance,            we  design    them, 13 fabricate them and test them commensurate with the 14 criteria set forth in ANSI/ANS-15.8, which are the 15 quality assurance requirements for research reactors.
16 SHINE implements that ANSI/ANS-15.8 standard through 17 our Quality Assurance Program description, or QAPD.
18                    Next slide, please. On this slide we have 19 the safety-related definition that SHINE applies to 20 design. This is a comprehensive definition that we've 21 modified from 10 CFR 50.2 and we've also included the 22 requirements        from    10  CFR    70.61,      the  performance 23 requirements        there    as    they're        applicable      to    the 24 radioisotope production facility.
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104 1 that are relied upon to meet any of the six criteria 2 listed here.        The first three are modifications of 10 3 CFR 50.2 and include the integrity of the primary 4 system boundary, the capability to shut down our 5 target solution vessel in a radiation process and 6 maintain at shutdown, and the capability to prevent 7 accident dose consequences that would exceed 10 CFR 8 20.
9                  And the last three are familiar to the 10 fuel cycle facility folks.              These are to ensure that 11 our nuclear processes remain subcritical including the 12 use of an approved margin of subcriticality, to ensure 13 that chemical exposures from accidents are acceptable 14 for both the worker and the public, and that an intake 15 of 30 milligrams or greater of soluble uranium does 16 not occur for personnel outside the owner-controlled 17 area, the OCA.
18                  Next slide, please.                For our SSCs we 19 require them to be designed to withstand external 20 events.        Our outer building structure is designed to 21 resist external events such as tornadoes, aircraft 22 impacts and other external events.                    And also the SSCs 23 within the building are required to withstand our 24 design-basis          earthquake          if      they    perform        a 25 safety-related function or they're necessary to ensure NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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105 1 they        do    not    degrade        the      performance    of      a 2 safety-related SSC.
3                    We also apply a graded quality level to 4 the design of our SSCs.              We have three quality levels 5 as described here.            Quality Level 1 is applied to our 6 safety-related components SSCs, and that is the full 7 measure of our QAPD is applied to those SSCs.                        Also, 8 we apply Quality Level 2 to SSCs that could affect the 9 safety function of safety-related SSCs specifically to 10 support or protect the safety function of those SSCs.
11 And we apply graded quality to those components that's 12 commensurate what their importance to safety.                            And 13 Quality Level 3 is applied to those SSCs that don't 14 meet the definition of Quality Level 1 or 2.
15                    Next slide, please.            We also apply single 16 family criterion to our systems.                      For safety systems 17 we ensure that there is sufficient redundancy and 18 independence such that a single failure of an active 19 component does not result in the loss of capability to 20 perform        the  safety      function.          And  for  accident 21 analysis        we    ensure      that      a    single    failure        in 22 conjunction with the initiating event does not result 23 in the loss of the safety system's ability to perform 24 the safety function. So throughout our design process 25 we use a robust defense-in-depth approach to design, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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106 1 and we have a strong preference in the design for 2 passive and engineered controls over administrative 3 controls.      And that concludes my presentation.
4                  CHAIRMAN BURNS:          Okay.      Thank you.      And 5 I'll ask the staff witnesses to come forward, take 6 their seats at the table.
7                  And I remind you that you're under oath 8 and start with the introduction of the witnesses.
9 Start with you, Mr. Lynch.
10                  MR. LYNCH:      My name is Steve Lynch.              I'm 11 the project manager for SHINE Medical Technologies on 12 the NRC staff.
13                  MR. ADAMS:      My name is Al Adams.          I'm the 14 Chief of Research and Test Reactor Licensing in NRR.
15                  MS. ADAMS:      Mary Adams.        I'm an engineer 16 in the Division of Fuel Cycle Safety Safeguards and 17 Environmental Review in NMSS.
18                  CHAIRMAN BURNS: Okay. Thank you. Please 19 proceed.
20                  MR. ADAMS: Good morning. This panel will 21 discuss        will    discuss          the        unique  licensing 22 considerations of the SHINE utilization and production 23 facilities.        I will discuss the general licensing 24 considerations and a review performed by the Advisory 25 Committee on Reactor Safeguards, the ACRS.                        Steve NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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107 1 Lynch will discuss the licensing of the irradiation 2 units and Mary Adams will discuss the licensing of the 3 production facility.
4                  Next    slide,      please.          SHINE  seeks        to 5 construct      non-power      utilization          facilities    and      a 6 production        facility.            Therefore,        an    initial 7 consideration was whether to license SHINE's proposed 8 facilities under Section 103 or Section 104 of the 9 Atomic Energy Act.        While the hazards associated with 10 SHINE's facility are similar to non-power research 11 reactors which are licensed under Section 104 of the 12 Atomic Energy Act, SHINE's facility is intended to be 13 used      for commercial      purposes,        not  for  conducting 14 research      and    development          or      medical  therapy.
15 Therefore,      while    the    licensing        process  would        be 16 similar to a research reactor, SHINE's facility would 17 be licensed under Section 103 of the Atomic Energy 18 Act.
19                  Section 103 imposes additional procedures 20 on    construction    permit      applications        including        an 21 independent review of the application by the ACRS and 22 a    mandatory    hearing,      which    we    are  having    today.
23 Because SHINE's facility is a subcritical system which 24 produces fission power, it introduces aspects of a 25 review typically done for non-power reactors.                          For NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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108 1 these areas the staff developed and used the Interim 2 Staff Guidance for NUREG-1537, which is a standard 3 review plan for non-power reactors.
4                    Next slide, please.            The staff presented 5 the      results    of  its    safety      review    at  three      ACRS 6 Subcommittee        meetings      and    before      the  full    ACRS.
7 During its review the ACRS identified two safety 8 concerns that could impact the operation of the SHINE 9 facility        if  not    sufficiently          addressed.        These 10 concerns were the capability to lay up the facility 11 and the facility's ability to withstand potential 12 aircraft impact.
13                    SHINE and the staff provided additional 14 information to the ACRS in these areas.                        The ACRS 15 determined that sufficient information was provided 16 such      that  it    could    recommend        the  issuance      of    a 17 construction permit. This recommendation is reflected 18 in the ACRS letter dated October 15th, 2015, which is 19 in the staff's SER.
20                    The  ACRS    letter      also    noticed  several 21 issues that must be addressed at the operating license 22 stage including criticality control and margin.                          The 23 staff agrees that each item that the ACRS identified 24 must be addressed at the operating license stage. And 25 Mirela was correct during her testimony that written NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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109 1 comments were not provided, or written commitments 2 were      not provided      by  SHINE      in    all  these    areas, 3 however, the staff is aware of them and we determined 4 that they're not needed for the issuance of the 5 construction permit, but will be addressed at the 6 operating license stage.
7                  Next slide, please.            Steve Lynch will now 8 discuss specific licensing considerations related to 9 the SHINE irradiation facility.
10                  MR. LYNCH:      Thanks, Al.          SHINE's proposed 11 irradiation        units      presented          unique    licensing 12 considerations        under    10    CFR    Part    50,  which      has 13 traditionally been applied to the construction and 14 operation      of  nuclear      reactors.            However,    unlike 15 nuclear reactors, SHINE's irradiation units are not 16 designed to go critical during operation.                  Therefore, 17 SHINE's irradiation units represent a new application 18 of technology.
19                  Given their subcritical nature the staff 20 considered        whether      it      should        review    SHINE's 21 irradiation units under 10 CFR Part 70 which can be 22 applied to certain facilities that possess and use 23 special nuclear material.            However, these facilities, 24 generally referred to as fuel cycle facilities, have 25 the common objective of avoiding criticality by a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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110 1 significant margin under both normal operating and 2 accident conditions.            In contrast, SHINE's minimal 3 margin of subcriticality is less than what has been 4 previously approved for other 10 CFR Part 70 licensees 5 and more closely resembles the operating state of a 6 nuclear reactor.
7                  Because of this the staff determined that 8 it would be most appropriate to use the 10 CFR Part 50 9 regulations for utilization facilities to perform its 10 technical review of the irradiation units. Therefore, 11 the NRC issued a direct final rule that revised the 12 definition of utilization facility in 10 CFR 50.2 to 13 add SHINE's subcritical operating assemblies.                            If 14 licensed, SHINE's irradiation units would be the first 15 utilization        facilities      to    operate      in  a minimally 16 subcritical range.
17                  Next slide, please.            Classifying SHINE's 18 irradiation units as utilization facilities allowed 19 the      staff  to  conduct      its    review      following      the 20 regulations designed for technologies with similar 21 radiological, health and safety considerations.                          In 22 particular, the accelerator and neutron multiplier of 23 each irradiation unit achieve a fission rate with a 24 thermal        power  level    comparable          to  that of    other 25 non-power reactors licensed under 10 CFR Part 50.
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111 1 Because of the thermal power levels the irradiation 2 units share similar safety considerations with other 3 non-power      reactors      including        provisions  for      the 4 removal of fission heat during operation, passive 5 decay heat generation after shutdown, fission gas 6 release and accident scenarios.
7                Given these safety considerations and the 8 functional similarities of the irradiation units to 9 non-power reactors, the staff relied on the guidance 10 provided in NUREG-1537 as supplemented by Interim 11 Staff Guidance for aqueous homogeneous reactors to 12 conduct its review.            Specific design areas of the 13 staff's review included SHINE's reactivity control 14 mechanisms, light water pool and biological shielding.
15                Next slide, please.            Mary Adams will now 16 discuss licensing considerations related to the SHINE 17 radioisotope production facility.
18                MS. ADAMS:        Thanks,        Steve. SHINE's 19 radioisotope production facility is distinct from the 20 irradiation facility. The RPF contains hot cells that 21 will process irradiated materials containing SNM in 22 batches of greater than 100 grams. Therefore, the RPF 23 is a production facility as defined in 10 CFR 50.2.
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112 1 performed at fuel cycle facilities.                    These processes 2 include the UREX and liquid waste evaporation and 3 solidification        processes.          With      the  exception      of 4 target solution preparation with fresh LEU, all of the 5 processes will be performed on irradiated special 6 nuclear material.              Therefore, the staff used the 7 guidance in NUREG-1537 as supplemented by Interim 8 Staff Guidance to guide its review of the radioisotope 9 production facility.
10                  The acceptance criteria in the Interim 11 Staff Guidance are drawn from NUREG-1520, the standard 12 review plan for fuel cycle facilities.                          The ISG 13 contains        baseline      design      criteria        and  accident 14 analysis guidance which include the criteria in 10 CFR 15 70.64.        As noted in the guidance, an application 16 meeting these baseline design criteria would b found 17 acceptable by the staff.              SHINE's construction permit 18 application proposed these acceptable baseline design 19 criteria for the RPF. After reviewing the application 20 the staff finds that SHINE's application met these 21 baseline design criteria.
22                  Next slide, please.            In doing its review 23 the      staff  identified      certain        items    that  must      be 24 addressed prior to the completion of construction, 25 therefore, the staff is recommending certain permit NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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113 1 conditions.        In particular, the staff has proposed 2 four criticality safety permit conditions which are 3 confirmatory and require SHINE to submit periodic 4 reports to the NRC.
5                  These reports must address the technical 6 basis of the criticality accident alarm system, the 7 basis for determining that criticality events are not 8 credible for the RPF processes, criticality safety 9 analyses for processes using fissile material and the 10 reactivity contributions from all fissile isotopes.
11 The staff is also recommending a permit condition 12 related to radiation protection to ensure shielding 13 and occupancy times within the RPF are consistent with 14 as low as is reasonable achievable practices and dose 15 requirements of 10 CFR Part 20.
16                  This concludes the staff's remarks for 17 Safety Panel 1.        We will respond to any questions you 18 may have at this time.
19                  CHAIRMAN BURNS:          Okay. Thank you very 20 much.        And what I would ask the staff -- now, Mary, 21 you're probably okay, but Mr. Lynch and Mr. Adams, if 22 you could maybe slide over this way, then we have a 23 good -- we can see all the witnesses at once as we 24 begin our questions.            And we'll begin our questions 25 for this panel with Commissioner Ostendorff.
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114 1                  COMMISSIONER        OSTENDORFF:        Thank      you, 2 Chairman, and thank you all for your briefs.                          I do 3 have a question for the Applicant, and I'm going to 4 your slide 6.        And under the single failure criterion 5 being applied to safety systems, I just wanted to ask 6 a high-level design philosophy question, if I could.
7                  Can you talk a little bit about how your 8 single failure does not result in a loss to the 9 ability to perform its function?                    Can you talk about 10 how      you  apply  that      concept        to  reliability        of 11 electrical power as it affects instrumentation control 12 or alarms?
13                  MR. VAN ABEL:          Yes, for instrumentation 14 control and electrical power we have very minimal 15 requirements for those for safety-related purposes.
16 And those that we do have are primarily for hydrogen 17 mitigation after shutdown and some instrumentation 18 control        systems    that      monitor        the  system    after 19 shutdown.            And      those      are      provided    by      an 20 uninterruptible        power      supply      system    that will        be 21 designed based on single failure criterion to look at 22 failure of components such as a breaker supplying 23 power to ensure that there's redundant reliable means 24 to supply that power to the equipment requiring it.
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115 1 your        criticality    alarm      system,        does  that      have 2 redundant power supplies?              Or that may not have been 3 designed yet; I don't know, but where does that fall 4 with respect to this philosophy of redundancy?
5                  MR. VAN ABEL:          It would be.        It's not 6 designed yet, but it's a safety-related system, so --
7                  COMMISSIONER OSTENDORFF:              Okay.
8                  MR. VAN    ABEL:        --    these  same    design 9 principles would apply.
10                  COMMISSIONER OSTENDORFF:                Okay.      Thank 11 you.
12                  Let me shift back to the staff now. Mary, 13 I wanted to ask you a question on your slide, I think 14 7 -- excuse me, 8. There's a reference to criticality 15 events not being credible.                  Can I just ask you to 16 elaborate on that just a little bit about what's the 17 basis for that statement?
18                  MS. ADAMS: 10 CFR 70.61, which formed the 19 basis of the Interim Staff Guidance, states as an 20 acceptance criterion that all processes need to be 21 subcritical        under      normal      and      credible  abnormal 22 operating conditions.              And so, what exactly does 23 "credible abnormal" mean?              And we ask our applicants 24 to very carefully define what they mean by credible 25 and not credible with respect to criticality safety.
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116 1                COMMISSIONER OSTENDORFF: So with respect 2 to the design aspects of what's been presented to the 3 NRC staff how is that achieved?
4                MS. ADAMS:      I want to call on --
5                COMMISSIONER        OSTENDORFF:          Or    as      a 6 condition of not having a credible criticality event.
7                MS. ADAMS:      I'd like to call on Dr. Chris 8 Tripp to answer that question.
9                CHAIRMAN      BURNS:          Okay. And    please 10 identify yourself for the record and confirm that you 11 took the oath earlier.
12                DR. TRIPP:      Okay.      I'm Christopher Tripp.
13 I'm the criticality safety reviewer in FCSS for the 14 RPF, and, yes, I did take the oath.
15                CHAIRMAN BURNS:          Okay.      Please proceed.
16                DR. TRIPP:          Okay.        With  regard        to 17 credibility, when SHINE originally provided their PSAR 18 section on criticality safety, they said that they 19 were going to design it so the criticality would be 20 not credible and then any controls so identified would 21 be identified as SSCs.            This was meant to meet the 22 performance requirements.
23                Some of those criteria that were mentioned 24 were from the performance requirements of Part 70.
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117 1 that          we    required          criticality          and      other 2 high-consequence events to be highly unlikely and then 3 those items that we identified as items relied on for 4 safety under the Part 70 framework.                      So there seemed 5 to be some confusion as to what the exact -- how that 6 would be applied to the RPF.
7                    And in the fuel cycle area we have had a 8 lot of discussions in the existing fuel facilities 9 concerning the basis for deciding events are credible 10 or not credible, and when you have to make that 11 demonstration and what you're allowed to take credit 12 for.        So this has been an ongoing issue with the 13 industry.          Therefore, we proposed these conditions to 14 give us additional confidence that they understood 15 what they were committing to be able to apply that 16 acceptably in the design.
17                    COMMISSIONER OSTENDORFF: Okay. Well, are 18 you expecting this condition to lead to articulation 19 of specific engineered features as far as volume 20 control on solution or can you be a little more 21 specific        as  to  how    this    might        play  out  in    the 22 facility's actual design?
23                    DR. TRIPP:        Yes.      So the first step in 24 applying          the  criteria      --    the      main    criteria      for 25 criticality is they be subcritical under normal and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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118 1 credible abnormal conditions.                  So the first step of 2 that is identifying what are the credible criticality 3 hazards        and  then    designing        the      different    safety 4 barriers against that.            So it's at that first step of 5 deciding what is credible and what hazards have to be 6 protected against that we would want to make sure that 7 they had an acceptable way of doing that.
8                    COMMISSIONER OSTENDORFF: So what are some 9 examples?          I'm trying to get to a more practical 10 engineered feature discussion here.                      What are some 11 examples        of  how  the    licensee        might  satisfy      that 12 condition?
13                    DR. TRIPP: Well, there are three criteria 14 for what they consider credible:                    One is an external 15 event with frequency of 10 to the minus 6th based on 16 the fuel cycle guidance that was incorporated into the 17 ISG.      The other is basically a string of independent 18 events that together collectively make up a set of 19 unlikely events that would have to occur that we 20 wouldn't think are credible.                  And the third is that 21 they'd be physically impossible.
22                    COMMISSIONER OSTENDORFF:              So is there an 23 example of the physically impossible that you can 24 offer for us?
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119 1 examples that apply directly to SHINE because we 2 haven't reviewed specific design features at this 3 point.        We've only reviewed the design criteria.                    And 4 the other fuel cycle arrangement -- for example, most 5 of the processing, the solution processing, which is 6 similar to what they have in other parts of the fuel 7 facility,        are  in    safe      geometry        containers,      safe 8 geometry columns and so forth.                  And one of the things 9 you have to guard against is backflow.                        So a lot of 10 the time they're protected against with say a siphon 11 break or an overflow or something of that nature so 12 that -- liquid doesn't flow against gravity.                            That 13 would be considered incredible.                    But it's only based 14 on having that passive feature in the design.
15                    COMMISSIONER OSTENDORFF:                Okay.      That 16 example was very helpful.                  Thank you.        Thank you, 17 Chairman.
18                    CHAIRMAN BURNS: Thanks you. Commissioner 19 Baran?
20                    COMMISSIONER BARAN:              Thanks. I want to 21 ask      about    slide    4    of  SHINE's        presentation      which 22 relates to the definition of structures, systems and 23 components.          The proposed definition, SSC definition 24 states in bullet 3 that SSCs assure the capability to 25 prevent or mitigate the consequences of accidents NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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120 1 which could result in potential exposures comparable 2 to Part 20.        The definition also states in bullet 6 3 that SSCs assure that an intake of 30 milligrams or 4 greater of uranium in soluble form by any individual 5 located outside the owner control area does not occur.
6                  The NRC's occupational dose requirements 7 in Part 20 state that the licensee shall limit the 8 soluble        uranium    intake      by  an      individual    to      10 9 milligrams in a week in consideration of chemical 10 toxicity. Can SHINE discuss the basis for setting the 11 SSC definition at no more than 30 milligrams?                          How 12 does that line up with -- how is that reconciled with 13 the Part 20 requirements?
14                  MR. HENNESY: The definition in Part 6, or 15 the term in Part 6 was derived from the 10 CFR 70.61 16 performance requirements, and that's what it reflects 17 back as.
18                  As far as the 10 CFR 20 requirements, our 19 concern, they would still be applicable and we would 20 still apply that under No. 3.                So we'll have to look 21 at your --
22                  COMMISSIONER BARAN:            Okay.
23                  MR. HENNESY:        -- comment and think about 24 that.
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121 1 there's a time frame that applies to the 30-milligram 2 level?
3                  MR. HENNESY:        I'm not aware of one.
4                  COMMISSIONER BARAN:            Okay.
5                  MR. HENNESY:        Eric, do you have any idea?
6                  MR. VAN    ABEL:        It's      for  an  accident 7 evaluation for --
8                  COMMISSIONER BARAN:            Okay.
9                  MR. VAN ABEL:        -- normal operations.
10                  COMMISSIONER BARAN:            So that's basically 11 total intake --
12                  MR. VAN ABEL:        Yes.      Right.
13                  COMMISSIONER BARAN:                -- over whatever 14 period of time?
15                  MR. VAN ABEL:        That's correct.
16                  COMMISSIONER BARAN:            Okay. And then the 17 Part 20 standards have a limit of 10 milligrams per 18 week.        Maybe I'll ask the staff to comment on this.
19 How did you all conclude that the proposed definition 20 element of an intake of 30 milligrams of uranium in 21 soluble        form  is    an    acceptable          limit  for      the 22 definition?
23                  MS. ADAMS:          I'd like to call on Greg 24 Chapman, the health physicist who reviewed the RPF.
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122 1 physicist.        I did take the oath.
2                  COMMISSIONER BARAN:            Great.
3                  MR. CHAPMAN:          With regards to the 10 4 milligram or 30-milligrams, 30 milligrams is typically 5 the criteria that replaced with the public for Part 6 70-type review.          And we typically look at it as an 7 acute exposure over 24 hours.                  So 10 milligrams for 8 accident exposure as well as 30 milligrams, I would 9 apply the same criteria, 24 hours.
10                  COMMISSIONER BARAN:            Okay. And so under 11 this definition the potential intake from a member of 12 the public of 30 milligrams looks to be about 3 times 13 higher than the limit you would have over the course 14 of a week for someone working at the facility, is that 15 right?
16                  MR. CHAPMAN:        That's correct.
17                  COMMISSIONER BARAN:              Okay. And can you 18 tell us a little bit more about how when you evaluated 19 that that that seemed like an acceptable result?
20                  MR. CHAPMAN:        I'd have to get back with 21 you on that.        I can't recall at the moment.
22                  COMMISSIONER BARAN:            I don't know if this 23 is      a    matter  of    temporal      issue      here  or  there's 24 something else at play, but maybe you could get back 25 to us on that.
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123 1                    Al or Steve, in prehearing question 15 we 2 asked        whether  the    application          specified how      many 3 irradiation units a single operator could control, and 4 both the staff and SHINE stated that that would be 5 addressed during the operating license application.
6 Can you talk a little bit about how the number of 7 operators relates to the size of the control room and 8 whether that's an issue that needs to be resolved now 9 at the construction permit stage?
10                    MR. LYNCH:      So that is something that we 11 haven't looked extensively at the construction permit 12 stage.        Some of the considerations:              More than just 13 the size of the control room, we're looking at the 14 layout of the control room, especially if there will 15 be operators looking at the production facility versus 16 the irradiation facility, and we need to get a better 17 understanding of how the controls will be laid out and 18 to make a determination on the number of operators 19 that are needed.
20                    COMMISSIONER BARAN: Okay. So in terms of 21 getting at the issue that Commissioner Svinicki raised 22 about not wanting a situation where someone has a 23 construction permit, they build something out, we look 24 at it later and say, no, no, that's not going to work 25 and people have to kind of redo things, from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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124 1 staff's point of view is the number of operators, 2 total number of operators that would be working in the 3 control room -- is that going to be relevant to the 4 layout, the construction of that control room in a way 5 that makes it something that we should address now at 6 the construction permit stage, or, no, it's just an 7 operating license issue?
8                MR. LYNCH:      So based on the information 9 SHINE has provided in their PSAR and discussions we 10 had with the ACRS on this issue, the staff hasn't 11 noted anything that would prevent the facility from 12 being able to operate.
13                COMMISSIONER BARAN: Okay. I want to also 14 ask about, follow up on prehearing question 11 related 15 to the probabilities used for aircraft accidents and 16 external design-basis accidents.                  I'm interested in 17 how the staff selected the size of the aircrafts for 18 this hazard analysis.        Did the staff look only at the 19 types of aircraft that could land or take off from the 20 nearest airport that the facility intends to be using 21 quite a bit, or did you also assess larger aircraft 22 that could potentially pass through the air space near 23 the proposed facility?
24                MR. LYNCH:        I think the best person to 25 respond to this question would be Steve Marschke.
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125 1                  CHAIRMAN BURNS: Again, Mr. Marschke, just 2 state your name for the record and your position and 3 confirm that you were put under oath.
4                  MR. MARSCHKE:        My name is Steve Marschke.
5 I work with Sanford Cohen & Associates, and we're 6 consulting staff on the chapter 2 review.                  And, yes, 7 I did take the oath.
8                  When we looked at the aircraft accident 9 probability analysis, we looked at really what SHINE 10 has done.      And they looked at all the accidents which 11 are -- or all the aircraft which land and take off at 12 that airport, the Southern Wisconsin Regional Airport.
13 And they have the statistics from the FAA which 14 identifies the types of aircraft, military aircraft.
15 And      most  of  them    are    air    carriers    and  commuter 16 aircraft and those types of aircraft.                    They've been 17 grouped into those categories.                  They also looked at 18 air corridors, which traverse the area.                    And so, we 19 kind of just -- we reviewed what the SHINE facility 20 has done.
21                  COMMISSIONER BARAN: In terms of those air 22 corridors -- so this is a relatively small regional 23 airport.      I assume the planes as you described are 24 relatively small that will be taking off and landing 25 from there. Are the air corridors that SHINE examined NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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126 1 and that you all looked at -- are those corridors that 2 involve much large aircraft?                    When we talk about 3 planes going to like O'Hare Airport in Chicago or --
4                  MR. MARSCHKE:        The air corridor is -- the 5 probabilities associated with the traffic in the air 6 corridors were very low.              And so, the air corridors 7 themselves fell below the probability cutoffs.                          And 8 it's really the aircraft which are utilizing the 9 regional      airport    which      challenge      the  probability 10 cutoffs.
11                  COMMISSIONER BARAN:            Okay. So any larger 12 aircraft beyond what would land or take off at the 13 regional airport didn't kind of pass the probabilities 14 level to be examined.          Is that correct?
15                  MR. MARSCHKE:        That's correct.
16                  COMMISSIONER BARAN:              Okay. Thank you.
17 And just one more question.                Prehearing question 35 18 focused on the assessment of accidental explosions at 19 the SHINE facility.          SHINE's response to the question 20 stated that they analyzed the potential impact of 21 natural gas pipelines on the facility.                  Can the staff 22 or SHINE, whoever makes sense; maybe the staff, Al or 23 Steve -- can you clarify which natural gas pipelines 24 are in the area of the proposed facility and how the 25 staff determined that they were not hazards?
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127 1                MR. LYNCH:      I think we're going to ask to 2 get some help here as well.
3                COMMISSIONER BARAN:            You're back.
4                MR. MARSCHKE:        I'm back.
5                (Laughter) 6                MR. MARSCHKE:        Can't get enough.
7                COMMISSIONER BARAN:            Still under oath.
8                MR. MARSCHKE:        Yes.      Well, my answer is 9 going to be I'm going to have to get back to you on 10 that, because in preparing for today's meeting I 11 wasn't really looking at the pipelines.                  I wasn't 12 anticipating    --  I    was    anticipating      the aircraft 13 questions, but not the pipeline questions, and so I 14 haven't briefed myself.          Maybe after lunch I can look 15 at my notes and get back in touch.
16                COMMISSIONER BARAN:              Is this something 17 that the staff has looked at?
18                MR. MARSCHKE:        No, we have looked at it, 19 but I just haven't looked at it recently and I don't 20 want to misinform the Commissioners.
21                COMMISSIONER BARAN:            Okay.
22                CHAIRMAN BURNS:          What we can do, we can 23 either hold to the end of the day if the staff wishes 24 to provide a supplemental answer, or we'll proceed 25 with putting it for perhaps a question following up.
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128 1                COMMISSIONER BARAN:              That makes sense.
2 Thank you, Mr. Chairman.
3                CHAIRMAN BURNS:          Thanks, Commissioner.
4                COMMISSIONER        BARAN:          That's  all      my 5 questions. Thank you.
6                CHAIRMAN BURNS:        A couple things:        Just I 7 guess to -- given some of my colleagues' questions 8 regarding the facility and all, can -- probably the 9 Applicant's the best idea.            In looking at some of the 10 slides -- it's actually from the first -- the overview 11 presentation,    can    you    give    me      an  idea  of      the 12 footprint, the area or size of the facility itself?
13 Because I've got picture, but it could be a doll house 14 or a large enrichment facility.                So just give me an 15 idea of the footprint.
16                MR. HENNESY:        The main building size is 17 around 55,000 square feet --
18                CHAIRMAN BURNS:          Okay.
19                MR. HENNESY: -- which is a little over an 20 acre in size. The whole site is 91 acres, so --
21                CHAIRMAN BURNS:          Yes.
22                MR. HENNESY: -- we're a dot in the middle 23 of a large area.
24                CHAIRMAN      BURNS:            Okay.      And        so 25 location-wise within that 91 acres are you sort of in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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129 1 the middle of it?          Is that the intention?
2                  MR. HENNESY:        Yes.
3                  CHAIRMAN BURNS: So you have a large -- in 4 fact      what  we'd    call    in    a    reactor      facility      the 5 owner-controlled area in that case?
6                  MR. HENNESY:        That's correct.
7                  CHAIRMAN BURNS:          Okay.      What is this --
8 and I'm looking and I just don't recall -- what is the 9 seismic design-basis for the facility?                        Either the 10 Applicant or the staff can respond to that.
11                  MS. KOLB:        The staff can -- or I mean 12 SHINE can respond to that.              I'd like to ask Alan Hull 13 to take that.
14                  CHAIRMAN BURNS:          Okay.
15                  MR. HULL:      Good morning.          My name is Alan 16 Hull.        I work for Golder Associates.                I'm a seismic 17 hazard specialist.
18                  CHAIRMAN BURNS:          And you were put under 19 oath earlier?
20                  MR. HULL:      I put under oath, yes, and I 21 took it.
22                  CHAIRMAN BURNS:          Please proceed.
23                  MR. HULL:          So    for      the  design-basis 24 earthquake you notice there were three stages.                        I can 25 comment only on the analysis that was done to come up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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130 1 with the ground shaking, and the structural engineer 2 for SHINE will able to talk about how that flowed on 3 into the actual design of the facilities.
4                    From our analysis we found that this part 5 of the United States is one of the lowest seismic 6 hazards in the area.            In fact, there were only about 7 58 earthquakes within 200 miles in the last 200 or so 8 years.        So when we looked at where the seismic design 9 should come from, we analyzed all those facilities as 10 we might have done for a power reactor.
11                    CHAIRMAN BURNS:          Yes.
12                    MR. HULL:      And by looking at the United 13 States geological survey seismic hazard model for the 14 United States we determined that a magnitude 5.8 15 earthquake        is  the    likely      design-basis    or  maximum 16 earthquake for this facility.                  The standard is about 17 0.2 g.
18                    CHAIRMAN BURNS:          Okay.
19                    MR. HULL:      That's 20 percent of the force 20 of gravity.          We looked at that seismic hazard model 21 for the United States and found that has a return 22 period of about 20,000 years.
23                    CHAIRMAN      BURNS:            Okay. And        my 24 recollection from a long time ago dealing with some 25 other facilities is that 0.2 g -- the shaking force is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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131 1 more or less equivalent to what I think a number of 2 the other reactors are designed for.
3                  MR. HULL:      That's my understanding.              And 4 my understanding also -- and again, a structural 5 engineer from Sargent & Lundy could provide more 6 detail.        My understanding is that that value of 0.2 g 7 is being used for the structural design of the Quality 8 1 facilities.
9                  CHAIRMAN BURNS: Okay. All right. Thanks 10 very much.
11                  The other thing is I'd ask the Applicant; 12 and the staff can certainly add, is what analysis of 13 flooding hazards were done with respect to the site?
14 And again, I know nothing of the site, so it may be a 15 silly question and it may not be.                    But, please.
16                  MS. KOLB:        We did do flooding hazards 17 analysis.          We  looked      at    the      probable  maximum 18 precipitation events and the probable maximum flood.
19 The Rock River is about two miles from the sites, but 20 the difference in elevation from the site elevation to 21 the Rock River, even in the probable maximum flood 22 situation, is still about 50 feet below the elevation 23 of the sites.          So that was determined to not pose a 24 hazard to the facility.
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132 1 based on the area of the sites, it comes up to about 2 the elevation of the site and the probable maximum 3 precipitation events, which we did analyze, but it 4 does not flood the structure.                And if you'd like more 5 detail, we have a geotechnical engineer from Golder 6 that could answer, provide more detail.
7                  CHAIRMAN BURNS:          I think that's good for 8 now.      Thank you.
9                  The final question I'll have here is with 10 respect to any analysis that were done with respect to 11 control or mitigation of release of tritium from the 12 facility since it does use tritium, and that's been an 13 issue, and it may be again.              Because of the design it 14 may not be as much of an issue for you all, but it has 15 been an issue at some nuclear power plant sites.
16                  MR. HULL:        Yes.      Yes, as I mentioned 17 before, we have a tritium purification system and the 18 accelerators themselves use a tritium gas target.
19 There are number of features there to control and 20 prevent the release of tritium to the environment.
21 One of the primary ones is that second confinement 22 barrier, the double-walled pipe around the tritium 23 piping.        And the tritium processing equipment is in 24 glove boxes, and those glove boxes are continuous 25 scrubbing of the atmosphere to remove tritium from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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133 1 atmosphere,        the    glove      box      and    maintain      that 2 concentration extremely low.                And any discharges from 3 the glove box are monitored and ensured that they're 4 below acceptable limits.
5                  CHAIRMAN BURNS:          Okay.        Thank you very 6 much.        Thank you. Commissioner Svinicki?
7                  COMMISSIONER SVINICKI:              Thank you all for 8 your presentations. I just have one question. It can 9 be either the staff or the Applicant and which subject 10 matter expert I guess gets to a microphone more 11 quickly, because it's kind of a background question.
12                  10 CFR Part 50, Appendix B QA Program 13 requirements are of course are applicable to power 14 reactors, so they are not in the strictest sense 15 applicable        to    the      SHINE      construction        permit 16 application.          SHINE's      slide      3    states  that      the 17 application        was  prepared        in    accordance      with      the 18 criteria set forward in ANSI/ANS-15.8 QA for research 19 reactors.
20                  Could someone though who is familiar --
21 I'm more familiar with Appendix B and the component 22 elements of that.            What is it that is missing or 23 sacrificed in terms of not using Appendix B versus 24 using the ANSI/ANS standard?                  Both to my knowledge 25 provide for a graduated approach to QA requirements, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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134 1 so    is    there  any    QA    expert      of    the  staff    or    the 2 Applicant who could tell me kind of what is sacrificed 3 between the two? I assume that the Part B -- Appendix 4 B, I'm sorry, QA Program is more rigorous somehow.
5                    Well, I mean, maybe -- and the other 6 question would be; and maybe this will be a follow-up 7 or something to be answered at the end of the day, if 8 possible.        Are all the requisite elements that are 9 required in an Appendix B program for coverage of QA 10 --    are    those  same    elements      of    addressed    in    the 11 ANSI/ANS standard?
12                    MR. ADAMS:      I think I can --
13                    COMMISSIONER SVINICKI:              Okay. Thank you.
14                    MR. ADAMS:        -- take a try at that.                  So 15 indeed the research reactors follow ANS 15.8, which is 16 endorsed by Regulatory Guide 2.5, Quality Assurance 17 Requirements for Research and Test Reactors.                            This 18 standard        was  developed        by    the    ANS  15  Committee, 19 Research        and  Test      Reactor      Committee,      and    it    was 20 developed because Appendix B did not apply to research 21 reactors as written.
22                    The coverage areas are the same. In fact, 23 the ANS standard goes a little bit further because it 24 includes        additional      quality        assurance      area        of 25 experiments, which you don't see in power reactors.
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135 1 Also,        the  ANS    standard      was      written    with      the 2 realization        that    the    definition          of  SSCs    in    the 3 regulations was written for power plants and may not 4 be strictly applicable to research reactors.
5                    Are you sacrificing something?              The staff 6 does not believe so given the difference between power 7 reactors and research and test reactors. Based on the 8 Quality Assurance Program from SHINE, the answers to 9 RAIs and the scope of the standard, and also the 10 Interim Staff Guidance to NUREG-1537 we believe that 11 using        ANS  15.8    is    applicable          for  meeting      the 12 requirements in 50.34(a)(7) for a Quality Assurance 13 Program.
14                    COMMISSIONER SVINICKI:              Okay. Thank you.
15 That's a very complete answer.                    I don't require any 16 supplement to that.            Thank you, Mr. Chairman.
17                    CHAIRMAN BURNS: Okay. Well, thank you to 18 our morning panels for their presentations.                        We will 19 now adjourn until 1:30 p.m. and we'll take up Safety 20 Panel 2.
21                    (Whereupon, the above-entitled matter went 22 off the record at 11:59 a.m. to reconvene at 1:30 23 p.m.)
24                    CHAIRMAN BURNS:            Okay, we'll call the 25 afternoon        session    of    the    hearing        on  the    SHINE NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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136 1 application to order for a Construction Permit.
2                    I'll ask the -- well, actually, what we'll 3 do, we'll hear both from the Applicant and then we'll 4 hear from the staff.              The staff can stay where they 5 are for the time being.
6                    But, we'll proceed with this afternoon's 7 panel.        I'll remind the witnesses that they are under 8 oath and ask you to introduce yourselves again as we 9 being the afternoon session.                        And then, you can 10 proceed.
11                    MR. COSTEDIO:        I'm Jim Costedio.      I'm the 12 SHINE Licensing Manager.
13                    MR. HENNESY: Bill Hennesy, the Manager of 14 Engineering for SHINE.
15                    MS. KOLB:          Catherine      Kolb,  I'm      an 16 Engineering Supervisor.
17                    MR. VAN ABEL:        Eric Van Abel, Engineering 18 Supervisor.
19                    CHAIRMAN BURNS:          Okay, please proceed.
20                    MR. COSTEDIO:        Good afternoon.
21                    For Safety Panel 2, I'd like to discuss 22 the Accident Analysis as presented in SHINE's PSAR.
23                    The basis for identification of accidents 24 for our PSAR was a Hazards and Operability Study.                        We 25 performed the HAZOPS, a Preliminary Hazards Analysis, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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137 1 a PHA. Both of those are rolled up into an Integrated 2 Safety Analysis.
3                  We also used the events from NUREG-1537 4 and the ISG augmenting NUREG-1537.
5                  We used the experience of our hazards 6 analysis team which included folks experienced in 7 nuclear plant operations and engineering personal 8 experience in reactor and nuclear process safety.
9                  Personnel familiar with process hazards 10 analysis and safety analysis modeling and methods, 11 personnel experienced with risk analysis and SHINE 12 system engineers familiar with the details of SHINE's 13 processes.
14                  And, this analysis was all done based on 15 our preliminary design information and we do expect to 16 update it with detail design and submit an updated 17 safety        analysis      with      our      Operating  License 18 Application.
19                  We  performed        qualitative      evaluations 20 within categories of accidents and then preformed 21 quantitative evaluation on the limiting accidents 22 within those categories.
23                  We also postulated a Maximum Hypothetical 24 Accident which is typical of the research reactor 25 community.        And that MHA was postulated for both the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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138 1 IF and the RPF.        And, I'll discuss both of those on 2 the next couple of slides.
3                  Next slide, please?
4                  In the IF, the MHA that we postulated was 5 a rupture of the target solution vessel and its 6 secondary vessel, the SASS, that surrounds it.                        So, 7 both of those vessels rupture, the target solution is 8 undergoing a radiation and spills into the IU cell.
9                  We ignore the pool.              This is all under 10 water, if you remember, and if we ignore that presence 11 in the pool so the material just spills and disburses 12 into the air.
13                  The high radiation is detected in the IU 14 cell and that initiates isolation of the cell and 15 evacuation alarms for personnel.
16                  The exhaust is filter through HEPA filters 17 and      charcoal  absorbers        and    the    calculated    dose 18 consequences from that event are 3.1 rem TEDE to the 19 work and 17 millirem at the fence for the public.
20                  Next slide, please?
21                  In the RPF, the MHA that we postulated was 22 found to have consequences more limiting than the IF 23 MHA, therefore, we designated the facility MHA.                    And, 24 that event was the rupture of the noble gas storage 25 tanks in the noble gas removal system.
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139 1                  Those tanks store the off gas from those 2 eight irradiation units after the irradiation cycle.
3 It's store there for decay and we postulated all five 4 of those tanks shown in blue on the figure on the 5 right          there,      rupture          simultaneously            and 6 instantaneously.
7                  The radiation in the room then initiates 8 confinement of that cell and high radiation alarms to 9 initiate evacuation.
10                  Some    material      bypasses      the  isolation 11 dampers and exposes and gets into the ductwork and 12 eventually to the public and some material leaks 13 through penetrations and exposes the workers.
14                  Next slide, please?
15                  The dose consequences for this event were 16 calculated to be 3.6 rem TEDE to the worker and 82 17 millirem at the fence for the public.
18                  These consequences were calculated in a 19 conservative manner.              There's several significant 20 conservatisms including a simultaneous instantaneous 21 rupture        of  these      five    tanks.        These  will        be 22 seismically designed, safety-related tanks with proper 23 isolation between the tanks, so we would not expect 24 multiple tanks to rupture.
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140 1 there's additional isolation dampers in the exhaust 2 ductwork that would trap a large fraction of these 3 radionuclides later on before they get out to the 4 exhaust duct.        But, those isolation dampers were not 5 credited in the analysis.
6                    So,  the      dose    consequences        would        be 7 significantly        lower      than    those        calculated    here.
8 However, the consequences are within the limits of 10 9 CFR 20.1101, 1201 and 1301.
10                    And, the figure on the right there shows 11 the dose from the SHINE accident on the left most bar.
12 The center bar is the 10 CFR 20 limit and the bar on 13 the right is the 10 CFR 50.34 dose guidelines for 14 power reactors for comparison.
15                    And, that concludes my presentation.
16                    CHAIRMAN BURNS:          Thank you.
17                    Now, we'll as the staff witnesses to come 18 forward.
19                    And,    I'll    remind        the    witnesses      that 20 they're under oath and I assume you all took the oath 21 earlier today, correct? Yes, and I want to remind you 22 you're        under  oath    and    why    don't      we  begin      with 23 introductions of the witnesses?
24                    MR. MORRISSEY:        I'm Kevin Morrissey.
25                    MR. LYNCH:      Dave Lynch.
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141 1                  MR. STAUDENMEIER:              Joe  Staudenmeier, 2 Senior Reactor Systems Engineer, Office of Research.
3                  CHAIRMAN BURNS:          Okay, thanks.        Please 4 proceed.
5                  MR. LYNCH:      So, this panel will discuss 6 the unique accident analyses considerations for the 7 SHINE Utilization and Projection Facilities.
8                  I'll    provide      an    introduction      to      the 9 staff's review methodologies.                  Joe Staudenmeier and 10 Kevin Morrissey will then discuss the specific details 11 of the staff's review and findings.
12                  Next slide, please?
13                  Based on the anticipated hazards at the 14 SHINE facility, two methodologies were applied to 15 postulated accident scenarios.                  Postulated accidents 16 at the SHINE facility were evaluated against the 17 radiological exposure limits in 10 CFR Part 20.
18                  Therefore, the SHINE workers are limited 19 to a total effective dose equivalent of five rem per 20 year      while  individual      members        of  the  public      are 21 limited to 100 millirem per year.                  This is consistent 22 with        the  exposure      limits      at      existing  research 23 reactors.
24                  The limiting radiological accident at the 25 SHINE        facility  is    referred        to    as  the  Maximum NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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142 1 Hypothetical Accident, or MHA.
2                  The MHA assumes a failure that results in 3 radiological releases and consequences exceeding those 4 of any postulated credible accident. The radiological 5 consequences resulting from the MHA are acceptable if 6 the resulting doses to workers and the public are less 7 than 10 CFR Part 20 exposure limits.
8                  In  addition        to  radiological      exposure 9 considerations, the radioisotope production facility 10 accident analysis used consequence and likelihood 11 criteria for potential accidents resulting in chemical 12 exposures.
13                  The staff evaluated SHINE's preliminary 14 radiological      and    chemical        consequence      likelihood 15 criteria, safety features and methods of assuring the 16 availability and reliability of safety features.
17                  Since the processes and hazards associated 18 with the SHINE radioisotope production facility are 19 similar to those at fuel cycle facilities.                  The staff 20 determined      that  SHINE's        use  of    integrated    safety 21 analysis methodologies as described in 10 CFR Part 70 22 is an acceptable way of both selecting the MHA and 23 demonstrating safety.
24                  Joe Staudenmeier will now discuss the 25 accident      analysis      considerations          for  the      SHINE NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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143 1 radiation facility.
2                  MR. STAUDENMEIER:          Thanks, Steve.
3                  The SHINE irradiation units operate at low 4 power and low pressure and, therefore, have low forces 5 to drive a radiological release.
6                  The target solution vessel and criticality 7 safe dump tank sit in a large pool of water that 8 provides passive decay heat removal.
9                  The    irradiated        target      solution        and 10 associated fission products and the tritium used in 11 the      accelerators    are    the    sources      of  radioactive 12 material that could be released during an accident.
13                  Next slide, please?
14                  SHINE has proposed and analyzed a set of 15 postulated accidents that should be representative of 16 the range of events that might happen in an operating 17 facility.      Postulated accidents provide insights into 18 the challenges to the safety systems of the facility.
19                  SHINE also analyzed how the potential 20 accidents      might    be    prevented          or  mitigated        by 21 administrative controls, engineered safety features 22 and trained personnel actions.
23                  The dose consequences were calculated to 24 determine the limiting accident.
25                  Next slide, please?
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144 1                  A typical SHINE accident scenario involves 2 a radioactive release into the irradiation unit pool 3 or atmosphere. The atmosphere in the irradiation unit 4 is connected by ducts to the ventilation system.
5                  There are isolation dampers on the ducts 6 that close in the event of a high radiation signal.
7 Workers are evacuated on a high radiation alarm.
8                  The releases reach the outside environment 9 after        passing  through      filters.        The calculated 10 releases are small enough that an acceptable emergency 11 planning zone could be the operational boundary.
12                  Next slide, please?
13                  The limiting accident for the irradiation 14 facility is a large rupture of one target solution 15 vessel.        The target solution and associated fission 16 products are released and no credit is given for 17 fission product scrubbing by the pool.
18                  The dose consequences from the limiting 19 accident in the irradiation facility are bounded by 20 the limiting accident in the radioisotope production 21 facility.
22                  This accident is a rupture of all noble 23 gas removal system storage tanks where gas is produced 24 in the irradiation process or stored while short-lived 25 radioisotopes decay.
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145 1                The  calculated          total      effective      dose 2 equivalent is 3.59 rems for workers, 82 millirems for 3 members of the public at the site boundary and less 4 than 12 millirems at the nearest residence.
5                The calculated doses meet the 10 CFR Part 6 20 acceptance criteria of five rem for workers and 100 7 millirem for members of the public.
8                Kevin Morrissey will now provide details 9 on the staff's evaluation of SHINE's radioisotope 10 production facility accident analysis.
11                Next slide, please?
12                RM. MORRISSEY:        Thank you, Joe.
13                In order to satisfy the 50.34 requirement 14 that a preliminary safety analysis report must assess 15 the risk to the public health and safety, SHINE 16 performed      an  Integrated        Safety        Analysis  of      the 17 radioisotope production facility.
18                This analysis included radiological and 19 chemical hazard and accident analyses for this portion 20 of the facility.
21                The  accident        analyses        determined      the 22 facility hazards that needed to be protected against 23 and help establish the design basis for this area.
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146 1 production facility incorporated adequate capabilities 2 and      features  to    prevent      or      mitigate  potential 3 accidents and to protect the health and safety of the 4 facility workers and the public.
5                  The staff's evaluation included review of 6 the following, the integrated safety analysis team, 7 the hazard evaluation process, the integrated safety 8 analysis        methodology,          the        completeness        of 9 identification of credible accident sequences, defense 10 in depth features of the design and safety related 11 design features such as process cells and facility 12 structures.
13                  Next slide, please?
14                  The staff reviewed multiple accident event 15 types such as radiological accidents including tank or 16 pipe failures and equipment malfunctions, chemical 17 accidents      including      tank    or    vessel    failures      and 18 exothermic reactions, criticality accidents, fires and 19 external events.
20                  The review of SHINE's non-radiological 21 accidents included chemical safety related accidents 22 and determination of chemical safety controls.
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147 1 chemicals produced from licensed material.
2                The staff also reviewed chemical risks of 3 plant conditions that affect the safety of licensed 4 material.
5                The    staff        determined        that    SHINE's 6 preliminary      facility        design        proposed    process 7 operations and safety controls for radiological and 8 chemical safety will perform their expected safety 9 function as intended and, thus, they will be adequate 10 to      protect  public      health      and      safety  and      the 11 environment.
12                The staff concludes that, for the purposes 13 of issuing a Construction Permit, there is reasonable 14 assurance      that  the    proposed      preliminary      accident 15 analysis of the SHINE facility adequately assessed the 16 risk to public health and safety.
17                The analysis also acceptably supports the 18 determination      of    the    facility        hazards    in      the 19 preliminary safety design including the engineered 20 safety features that protect the health and safety of 21 workers and the public.
22                This  concludes        the      staff  remarks      for 23 Safety Panel 2. And we are prepared to respond to any 24 questions at this time.
25                CHAIRMAN BURNS:          Okay, thank you.
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148 1                  What I'd ask the staff witnesses do is 2 maybe, Mr. Staudenmeier, if you can move to that seat, 3 move      a  little  closer      to    the      secretary  and      Mr.
4 Morrissey and Mr. Lynch and this way then we can all 5 see each other -- good visual from there and maybe 6 just a little bit closer to the secretary.                        That's 7 good, that's good.
8                  I  believe      we    start        the  questioning, 9 Commissioner Baran.
10                  COMMISSIONER BARAN:            Thanks.
11                  Steve and Joe, I wanted to -- now you're 12 very far apart -- but, I wanted to ask you about the 13 Maximum Hypothetical Accident for the irradiation 14 facility.
15                  As you mentioned, this involves failure of 16 one of the eight irradiation units.                    Now, in response 17 to pre-hearing questions five and six, the staff 18 stated that the irradiation units have been designed 19 to withstand any events that could cause multiple 20 units to fail simultaneously.
21                  That's a pretty strong statement and I 22 wanted to give you a chance to talk to us about how 23 you reached that conclusion.
24                  MR. STAUDENMEIER: Okay. As you said, the 25 units were isolated from each other, they're in robust NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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149 1 concrete shielding structures and they are designed to 2 withstand any design basis event like seismic or other 3 loadings on the system.          And, there's no real way for 4 a failure in one to trigger failures in others or a 5 chain reaction.
6                COMMISSIONER BARAN:            So, the staff looked 7 at tornados, earthquakes, floods, fires, aircraft 8 impacts, loss of offsite power and the staff concluded 9 that none of these events could cause more than one 10 irradiation unit to fail, is that right?
11                MR. STAUDENMEIER:              Well,  in terms      of 12 aircraft impact, the smaller aircraft that the type 13 that land at that airport, I know the facility is 14 designed to withstand impacts from those.
15                I don't think a large aircraft crash was 16 within the design basis of the facility.
17                COMMISSIONER BARAN: Okay, so with respect 18 to design basis events of those types?
19                MR. LYNCH:      Yes, that is correct.
20                COMMISSIONER BARAN:            Okay. Are there any 21 other kind of beyond design basis events besides 22 larger aircraft that you particularly have in mind 23 that could be an issue?
24                MR. LYNCH:      Not at this time, no.
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150 1 alluded to this a little bit, Joe, but are there --
2 could any of the common fill drain or off gas line 3 shared by the eight units result in an accident worse 4 than the Maximum Hypothetical Accident because of a 5 common mode failure?
6                  MR. STAUDENMEIER:          No, not that I'm aware 7 of.        I mean, there's one common mode failure for 8 cooling to the TOGS system, I think, in long term, but 9 the cells would be isolated by that time and SHINE was 10 going to look at that for, I think they had a survival 11 time of four hours maybe for power lasting and they 12 were going to look at that in the Operating License 13 Review.
14                  COMMISSIONER BARAN:            Okay. Well, let me 15 just give SHINE a chance if you wanted to add anything 16 on      the    Maximum    Hypothetical            Accident    for      the 17 irradiation units that the staff didn't cover.
18                  MR. VAN ABEL:          We did look at potential 19 for other events involving multiple units and we 20 didn't identify any potential events that would be 21 worse than the Maximum Hypothetical Accidents.
22                  COMMISSIONER BARAN:            Okay, thanks.
23                  Pre-hearing question 29 asked about safety 24 features for the transfer of the target solution to 25 the        radioisotope        production            facility      after NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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151 1 irradiation.
2                I'd    like      to    ask      the  staff,      what 3 criticality risks exist when the target solution is 4 transferred and how is that risk mitigated?
5                MR. LYNCH:      Yes, I think Chris Heysel did 6 a review on engineered safety features.                  If you would 7 like to say a few words on that?
8                CHAIRMAN BURNS: Again, identify yourself 9 and confirm that you were previously put under oath.
10                MR. HEYSEL:        For the record, my name is 11 Chris Heysel, I'm a Consultant with ISL.                  And, I did 12 take the oath earlier.
13                CHAIRMAN BURNS:          Please be seated.
14                MR. HEYSEL:        The engineering and safety 15 features are integral to both the IUs and the RPFs.
16 So, the both passive and active features will provide 17 the engineering safety features to mitigate normal and 18 offsite conditions.
19                The design of those features will control 20 a      criticality  accident        due      to    the  geometries 21 associated with them.
22                COMMISSIONER        BARAN:          And,  will      the 23 criticality accident alarm system include coverage for 24 the entire path that the target solution travels 25 during transfer?
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152 1                MR. HEYSEL:      I am not the correct witness 2 to talk about the criticality alarm system.
3                COMMISSIONER BARAN:            Okay.
4                Very quickly, anyone on the staff would 5 care to answer that?
6                MR. LYNCH:          Chris, would you like to 7 discuss the criticality accident alarm system and the 8 areas of coverage?
9                COMMISSIONER BARAN:            Just briefly.
10                CHAIRMAN BURNS:          Identify yourself.
11                MR. TRIPP: Chris Tripp and I did take the 12 oath.
13                Yes, we don't have the design details of 14 the criticality alarm system in detail.                    However, 15 SHINE has not identified any areas where they'd be 16 taking exceptions.
17                So,  anywhere      there      is  vessel  nuclear 18 material present, we understand that they would have 19 coverage of those areas.
20                COMMISSIONER BARAN:            Okay, great.      Thank 21 you.
22                Thanks, Mr. Chairman.
23                CHAIRMAN      BURNS:        I    had  a  couple      of 24 questions in terms of the review and the accident 25 analysis.
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153 1                What are, and I think SHINE and/or the 2 staff can address this, what are the most significant 3 natural hazards that you had to focus your design on?
4                MS. KANATAS:        I guess we can go first.
5                So, we looked at natural hazards involving 6 flooding, as I spoke about earlier today.            We looked 7 at the design basis aircraft, that's not really a 8 natural hazard, that's an external event.
9                We looked at the tornados, historical 10 maximum tornados.        We used guidance from Regulatory 11 Guide, I believe it's 176 for the -- that's used for 12 power reactors for the spectrum and the wind speeds 13 for tornados.
14                We looked at tornado missiles.        Anything 15 else I'm missing?      I mentioned flooding.
16                CHAIRMAN BURNS: Okay. And, staff, do you 17 want to add on to that, the one other thing that SHINE 18 did look at this as well in addition to staff was the 19 rain, snow load on the facility as well as an external 20 event?
21                MR. LYNCH:      In terms of the roof of the 22 building?
23                CHAIRMAN BURNS:          Yes, yes.
24                MR. LYNCH:      Okay.
25                CHAIRMAN BURNS:          Yes.
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154 1                MR. LYNCH:      Okay.
2                CHAIRMAN BURNS: There's just -- actually, 3 part        of our  discussion        focused      on  not      only 4 radiological hazards, but chemical hazards and, I 5 think in the description of the facility, for example, 6 sulfuric acid is used in part of the process.
7                What    are    the      significant    potential 8 chemical hazards that are involved with the facility?
9                MR. VAN ABLE:        For SHINE.
10                We looked at a variety of chemical hazards 11 in the facility.        We do have sulfuric acid, nitric 12 acid, other acids and bases.
13                We identified 24 chemicals of concern that 14 we use throughout the process and 11 of them were 15 explicitly modeled because of their -- either their 16 toxicity, their dispersibility or inventory. And that 17 includes things like the acids I mentioned, calcium 18 hydroxide,      caustic      soda,        ammonium    hydroxide, 19 N-dodecane, potassium permanganate, tributyl phosphate 20 which is part of the UREX process and uranyl nitrate 21 and a couple of proprietary chemicals as well.
22                CHAIRMAN BURNS:          Okay. From the -- go 23 ahead, Mr. Lynch.
24                MR. LYNCH:      Yes, I would just say as far 25 as the chemical hazards and concern, the staff is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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155 1 expecting hazardous chemicals to be in very small 2 quantities at the facility.
3                  The only chemicals that could exceed large 4 quantities which we're considering to be greater than 5 1,000 pounds would be nitric acid or sulfuric acid.
6 And, there are a number of processes that we are 7 evaluating that involve these chemical hazards and 8 this includes the preparation of the target solution 9 vessel, the radioisotope production, extraction and 10 purification system, target solution clean up and any 11 waste operations.
12                  CHAIRMAN BURNS:          Okay. In terms of the 13 control        of  those    types      of    hazards,    do  we    look 14 primarily to the regulatory footprint or authority of 15 other agencies or how is that integrated in terms of 16 what        the  staff      would      evaluate      in    terms        of 17 acceptability for both the Construction Permit, but 18 looking forward, if we came to a point of an Operating 19 License, what would we do?
20                  MR. MORRISSEY:            Well,    typically,        we 21 evaluate chemical hazards in Part 70 under 70.61. So, 22 we use that and SHINE, that is one acceptable way of 23 doing things and SHINE preferred to take that way.
24                  CHAIRMAN BURNS:          Okay.
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156 1 guidance        through    15.20    on,    you      know,  how  to      do 2 chemical safety evaluations.
3                    CHAIRMAN BURNS:            Okay.        And, just to 4 confirm my understanding on the Maximum Hypothetical 5 Accident that was described is, I understand, or the 6 slides        in  the  presentation,          in      that  event,      the 7 expectation would be that a worker dose would be less 8 than the normal occupational dose that is permitted 9 under Part 20, is that correct?                      I thought I heard 10 something like 3 point X rem.
11                    MR. VAN ABEL:        Yes.
12                    CHAIRMAN BURNS:          Okay.
13                    MR. VAN ABEL:        That's correct.
14                    CHAIRMAN      BURNS:        And      then,  the    site 15 boundary dose to the public would be 82 millirem as 16 opposed to the 100 millirem?                So, then what we're --
17 at least from our understanding at this point for 18 purposes of Construction Permit, is you have doses 19 that are actually below what we'll call normal dose 20 limitations?
21                    MR. LYNCH:      Yes, that is correct.
22                    CHAIRMAN BURNS:          Okay.
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157 1 there was a comment made and I don't -- I think it may 2 have been one of the staff witnesses, but it may have 3 been SHINE, with respect to the size the -- or the, I 4 guess, not size but, perhaps, boundary of an emergency 5 planning        zone  was    described        as  the  operational 6 boundary.
7                    Can you describe for me what that means?
8 Does that mean the building or does that mean the 9 owner -- what I would call the owner controlled area?
10                    MR. LYNCH:      Yes, the operational boundary 11 would be the building itself.                  And, just to clarify, 12 that is something the staff is still evaluating as to 13 what in the Operating License.
14                    CHAIRMAN BURNS:          No, I understand, but I 15 appreciate that clarification.
16                    That's all I have.
17                    Commissioner Svinicki?
18                    COMMISSIONER SVINICKI:              Thank for your 19 presentations on this panel which were principally 20 regarding Chapter 13 Accident Analysis.
21                    In my preparation between reviewing the 22 record        itself  and    the    supplements      given  in    the 23 response to pre-hearing questions, I found there to be 24 a very complete and exhaustive discussion of the 25 Maximum Hypothetical Accident.                    So, I was satisfied NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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158 1 with answers to my questions on those points.
2                So, I do have two questions that relate to 3 Chapters 11 and 12.        And, Chapter 11 addresses waste 4 management issues.
5                This is for, I think both of my questions 6 will be for the Applicant witnesses.
7                SHINE has indicated that greater than 8 Class C low level waste would be generated as a result 9 of operating the facility, is that correct?
10                MS. KANATAS:        Yes, we do have that in our 11 PSAR.
12                COMMISSIONER SVINICKI:              Okay. So, my 13 question is, if there is no national disposal pathway 14 for your greater than Class C waste, would you have 15 adequate ability to store that on your site for the 16 lifetime of the operations of the facility?
17                MS. KANATAS:        Before I answer that --
18                COMMISSIONER SVINICKI:              If not, what is 19 your other alternative plan?
20                MS. KANATAS:          So, our designations of 21 greater than Class C waste are two small waste streams 22 and that's based on our preliminary design and some 23 conservative assumptions.
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159 1 as it stands, we've had discussions with some license 2 disposal facilities that have the ability to store 3 greater than Class C waste.
4                    If SHINE did not have a commercial path, 5 either        a waste  control      specialist        or  some    other 6 commercial disposal or storage facility, then the 7 provision of the American Medical Isotope Production 8 Act has a provision to accept the wastes from medical 9 isotope productions and that's what we would --
10                    COMMISSIONER SVINICKI:              And that --
11                    MS. KANATAS:        And      that  would  be    our 12 fallback position.
13                    COMMISSIONER SVINICKI: And that provision 14 in the Act is for the Department of Energy or U.S.
15 Government to take that waste?
16                    MS. KANATAS:        The Department of Energy, 17 that's correct.
18                    COMMISSIONER SVINICKI:              Okay, thank you.
19                    And then, broadly, Chapter 12 is conduct 20 of operations, but broadly, as SHINE looks to the 21 future and the possible need for qualified operators, 22 very conceptually, what do you envision as the skills, 23 knowledge and abilities of the types of experience 24 that a qualified operator for this type of facility 25 would have?          Is it someone who has operated power NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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160 1 reactors or research and test reactors? Would that be 2 in general the requisite skill set or is it only 3 requiring some sort of smaller set of knowledge skills 4 and abilities?
5                    MR. COSTEDIO:          I mean, certainly, we'd 6 entertain the hiring folks with prior power reactor 7 experience and that would be good. Also, nuclear Navy 8 and engineers out of college.
9                    We plan on having a training program in 10 accordance        with  NUREG-1478        for    research  and    test 11 reactors, that's on the license and operators.
12                    We do have to do some work, you know, with 13 the staff on that to line that up with what we do.
14 But, we certainly plan on having a rigorous SAT-based, 15 you know, training process with exams and very, very 16 similar to what the research and test reactors do now.
17                    COMMISSIONER SVINICKI: Would you envision 18 having        any  sort  of    partnership          with local    maybe 19 technical colleges or others to develop a kind of a 20 qualified worker base for this facility going forward?
21 Is that something you've thought about?
22                    MR. COSTEDIO:            Yes,      with  Blackhawk 23 College, we've talked with them.
24                    Do you have more?
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161 1 the local technical colleges.                      There's one up in 2 Northeast Wisconsin which is in partnership with the 3 one down by Janesville that has done a lot of training 4 for RP personnel to work at the power plants that are 5 up there.
6                  And    so,      they've          been    looking        at 7 transferring those programs down to the Janesville 8 area and we expect that will be very useful to us to 9 help find good staff to staff our facility.
10                  COMMISSIONER SVINICKI:              Okay, thank you.
11                  Thank you, Mr. Chairman.
12                  CHAIRMAN BURNS:          Thank you.
13                  Commissioner Ostendorff?
14                  COMMISSIONER OSTENDORFF:              Thank you, Mr.
15 Chairman.
16                  I'm going to start off with the Applicant, 17 please.
18                  I recognize in the unique nature of the 19 SHINE        is conceptually      looked      at    today,  is    there 20 anything in the radiation detection arena as far as 21 equipment monitoring instrumentation that you would 22 characterize as never tried before of first-of-a-kind 23 engineering or first-of-a-kind instrumentation?
24                  MR. VAN ABEL:        No, you know, have various 25 radiation area monitors in the facility, continuous NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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162 1 air monitors, standard off-the-shelf type technology.
2                  We're looking at neutron flux detectors to 3 monitor the activity in the neutron population in the 4 TSV radiation.
5                  And, we're talking to existing vendors who 6 supply research reactors with that technology and it's 7 all within normal --
8                  COMMISSIONER OSTENDORFF:                So, as far as 9 neutron detectors, you expect to be able to use some 10 technology that's already on the market for that?
11                  MR. VAN ABEL:            Oh, yes, yes, that is 12 correct.
13                  COMMISSIONER OSTENDORFF:                Okay.
14                  Real    quick,      did    the      staff  see      any 15 challenges        in  this      area      for      either  radiation 16 protection or detection device approaches?
17                  MR. LYNCH:        As of now, we have not.
18                  COMMISSIONER OSTENDORFF:                Okay.
19                  All right, let me go back to the Applicant 20 just for real quick.
21                  On your slide four, several times there's 22 reference to the isolation dampers.                      I know dampers 23 are      pretty  straightforward,          but      dampers    can      be 24 complex.      And, are these manually operated?                Are they 25 operated by some solenoid or hydraulic system or can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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163 1 you talk about, in an accident scenario, how they'd be 2 operated?
3                  MR. VAN ABEL:          We haven't selected the 4 dampers yet.          They would not be manual operated, 5 they'd        be operated      by    some    actuation      mechanism, 6 hydraulic or pneumatic.
7                  We've looked at vendors that supply these 8 for the nuclear industry and there are many traces 9 available that we think will meet our criteria, but 10 they would be automatic actuated by the safety systems 11 and there would be fail close so their fail position 12 would be closed if you lose offsite power, they would 13 close automatically.
14                  COMMISSIONER OSTENDORFF:              And the use of 15 the word redundant in front of isolation dampers, does 16 that mean there's more than one damper in the flow 17 path of the ventilation?
18                  MR. VAN ABEL:        It means -- yes, not only 19 there would be two dampers, but every place that you 20 need an isolation capability.
21                  COMMISSIONER OSTENDORFF: All right, thank 22 you.
23                  I have no further questions.
24                  CHAIRMAN BURNS:          I was about to -- I did 25 this        last  time,    last      year,      I  always  went        to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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164 1 Commissioner Baran again, to redo a round, but I take 2 it without anything else, we'll dismiss this panel.
3                Thank you for your testimony and we'll 4 call up the environmental panel.
5                (Whereupon, the above-entitled matter went 6 off the record at 2:06 p.m. and resumed at 2:08 p.m.)
7                CHAIRMAN BURNS:          Well, thank you, again.
8                And, we'll, again, with this panel, we'll 9 have the testimony of the Applicant and then the staff 10 testimony, then proceed to questioning.
11                Again, I remind all the witnesses that 12 they remain under oath and I'll ask you, when you 13 start again and ask you to introduce yourselves, first 14 for the SHINE witnesses.
15                MS. PITAS:      Certainly.          My name's Katrina 16 Pitas. I'm the Vice President of Business Development 17 for SHINE.
18                CHAIRMAN BURNS:          Okay.
19                MR. HENNESY:          Bill Hennesy, Manager of 20 Engineer for SHINE.
21                MS. KOLB:        Catherine Kolb, Engineering 22 Supervisor.
23                MR. KRAUSE:          I'm Tim Krause.          I'm an 24 Environmental Coordinator for the project.
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165 1 all start?
2                  MS. PITAS:      Thank you.
3                  So, I'm going to give the environmental 4 overview for SHINE today.
5                  Next slide, please?
6                  On this first slide, you will see some 7 pictures of some of the site characterization work 8 that was done.        We began that work back in October of 9 2011 at the Janesville site which was chosen for the 10 SHINE facility.
11                  And, we did that site characterization 12 work      to  develop    the    environmental          report    which 13 followed the final Interim Staff Guidance augmenting 14 NUREG-1537.
15                  Next slide, please?
16                  This table shows the structure and the 17 content        of  the    Environmental            Report.      After 18 introducing the project, the Environmental Report goes 19 on to discuss the proposed action.                    It then goes into 20 a      detailed    description        of    the      affect  in      the 21 environment and the resources of the chosen site, 22 Janesville.
23                  Then, it goes on to analyze both the 24 impacts and the benefits of the SHINE technology on 25 the chosen site.
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166 1                    And then, it compares the impacts of the 2 SHINE technology at the Janesville site with the 3 impacts of the no-action alterative, what the impacts 4 of the SHINE technology would be at two alternative 5 sites, Chippewa Falls and Stevens Point.
6                    And then, it looks at the impacts of two 7 alternative technologies.
8                    It then goes on to discuss the conclusions 9 reached by the report.
10                    Next slide, please?
11                    The field investigations we needed to do 12 to      gather      the    information            to    complete        the 13 environmental report were thorough and very extensive.
14                    In addition to a Phase I environmental 15 site assessment and general site reconnaissance, the 16 geotechnical        investigation          consisted      of  15    soil 17 borings,        one    of    which      was      used  for    seismic 18 characterization, four of which were converted to 19 groundwater monitoring wells.
20                    A Phase I archaeological investigation, a 21 baseline visual assessment and a wetland delineation 22 were        all    performed        as    well      as    ecological 23 investigations        that      consisted        of  quarterly      field 24 surveys over the course of one year.                    Those looked at 25 both aquatic ecology and terrestrial ecology.
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167 1                  And, monthly ground and surface water 2 monitoring that looked at both water quality and water 3 levels.
4                  Next slide, please?
5                  The  context      for    our      data acquisition 6 varied depending on which resource was being analyzed.
7 Many of the investigations looked just at the SHINE 8 parcel itself which, as has been mentioned, is a 9 91-acre        parcel  on    the    south    side    of Janesville, 10 Wisconsin.
11                  Some of the investigations looked a little 12 bit broader at the project area which we consider to 13 be the one mile radius from the site center point.
14                  And then, other investigations looked at 15 the entire region surrounding the SHINE site, often up 16 to five miles in all directions from the center point.
17                  And then, for some of the resources like 18 geology and air quality, we looked at even larger 19 contexts as was appropriate to the resource.
20                  For socio-economic impacts, we looked at 21 what is known as the region of influence.                            That 22 corresponds to the area that incurs the greatest 23 impacts to community services that result from the 24 SHINE facility and the people who work at the SHINE 25 facility.        We determined that to be Rock County, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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168 1 Wisconsin.
2                  Next slide, please?
3                  We    also      conducted          a  number        of 4 consultations in preparation for the environmental 5 report.
6                  We talked to the City of Janesville, Rock 7 County, the Wisconsin Department of Natural Resources, 8 the Wisconsin State Historic Preservation Office, the 9 Wisconsin Department of Transportation, the U.S. Fish 10 and        Wildlife    Service,        the        Federal  Aviation 11 Administration, the Bureau of Indian Affairs and we 12 also contacted 13 Native American Tribes including two 13 Tribes located within the State of Wisconsin and 11 14 Tribes that were non-Wisconsin Tribes.
15                  Next slide, please?
16                  In addition to the impacts of constructing 17 and operating the SHINE facility at the Janesville 18 site, SHINE analyzed two alternative sites and the 19 no-action alternative.
20                  The SHINE project, as has been discussed, 21 results in a number of local, national and global 22 benefits.      These include the socio-economic benefits 23 for the local community consisting of tax benefits and 24 increased job opportunities.
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169 1 U.S.        Government    policies      to      encourage    domestic 2 production of medical isotopes and nonproliferation.
3                  But,    most    of    all,      the  SHINE  project 4 results in health benefits from a reliable, stable 5 supply of technetium-99m, for patients around the 6 globe.
7                  So,  in    light      of    these    benefits,      the 8 no-action        alterative      is    not      preferable    to      the 9 construction and operation of the SHINE facility.
10                  Although the no-action alternative would 11 avoid the environmental impacts associated with the 12 SHINE project, because all of these impacts are small 13 for the SHINE technology, avoiding these impacts is 14 not significant.
15                  And, the no-action alternative would not 16 impart the important benefits that I mentioned before.
17                  Looking at the two alternative sites, 18 Chippewa Falls and Stevens Point, neither alternative 19 site would reduce or avoid adverse impacts as compared 20 with the SHINE site.
21                  As shown in this table, the Janesville 22 site is the preferred site from an environmental 23 perspective, given that it has small impacts to all 24 resource        categories      while      the      alternatives      had 25 moderate impacts to some resource categories during NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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170 1 construction.
2                Next slide, please?
3                SHINE      also      analyzed      two  --      the 4 environmental impacts of two alternative technologies, 5 both the linear accelerator technology that would be 6 creating moly-99 from enriched or natural molybdenum 7 targets and a low enriched uranium aqueous homogeneous 8 reactor.
9                Both of these technologies are considered 10 reasonable alternatives to the SHINE technology for 11 the Janesville site from an environmental perspective.
12 But, neither of the alternative technologies would 13 reduce or avoid adverse impacts as compared with the 14 SHINE technology.
15                Next slide, please?
16                In mid-2013, the NRC staff conducted an 17 environmental    site    audit.        SHINE    gave the    staff 18 presentations on the SHINE technology and our site 19 selection process.
20                The staff then made a number of visits to 21 places of interest in the community.                Those included 22 the Janesville site and the surrounding area. We went 23 on a driving tour of about 4.4 miles around the site.
24                We visited the Rock River. We visited the 25 sites that were used for sampling along the nearby NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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171 1 unnamed        tributary.        We    visited        the  Janesville 2 Wastewater Treatment Facility which included a look at 3 the outfall structure to the Rock River.
4                  And, we looked at both alternative sites.
5 We traveled both to Stevens Point and the Chippewa 6 Falls.
7                  Next slide, please?
8                  SHINE believes the relationships between 9 the company, the City of Janesville and the State of 10 Wisconsin are incredibly important and we worked very 11 hard      to  build  and    continuously          strengthen    those 12 relationships        via    a  policy      of      transparency      and 13 frequent engagement.
14                  Supporting these principles, we ensure a 15 minimum of four public meetings with the community per 16 year, as I had mentioned earlier.                  And, actually, the 17 most recent of those happened on December 9th.
18                  As a result of these activities and these 19 efforts, we have a relationship with the community 20 that's based on trust, mutual respect and, I believe, 21 genuine enthusiasm for the SHINE project.
22                  Next slide, please?
23                  In conclusion, the SHINE environmental 24 review was conducted pursuant to 10 CFR Part 51 and is 25 adequate.        The requirements of Sections 102.2(a), (c)
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172 1 and (e) of the National Environmental Policy Act have 2 been satisfied and SHINE's weighing and balancing of 3 the      environmental,    technical      and    other  costs      and 4 benefits of the SHINE facility supports issuance of 5 the Construction Permit.
6                Thank you.
7                CHAIRMAN BURNS:          Okay, thank you.
8                We'll proceed now with the staff testimony 9 and I'd ask the staff witnesses to identify themselves 10 and then you can proceed.
11                MS. MARSHALL:        My name is Jane Marshall.
12 I'm the Deputy Director for the Division of License 13 Renewal in the Office of Nuclear Reactor Regulation.
14                MR. WRONA:      I'm David Wrona, the Chief of 15 the Environmental Review Branch in the Office of NRR.
16                MS. MOSER:        My name is Michelle Moser.
17 I'm the Environmental Project Manager in NRR.
18                CHAIRMAN      BURNS:            Okay,  thank      you.
19 Proceed.
20                MS. MARSHALL:        Okay, thanks.
21                If I can have -- you've got my slide, 22 thank you.
23                Good afternoon.          I'm Jane Marshall and 24 with me today to discuss the environmental review of 25 the SHINE facility are Dave Wrona and Michelle Moser.
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173 1                  Next slide, please?
2                  As I mentioned during my presentation 3 earlier this morning, part of the staff's review of 4 the SHINE Construction Permit Application included an 5 environmental review which was conducted in parallel 6 with the safety review that you heard about earlier 7 today.
8                  The  staff    performed        the  environmental 9 review in accordance with the National Environmental 10 Policy Act of 1969, commonly referred to as NEPA.
11                  In  doing    it's    NEPA      review,  the    staff 12 followed        the    environmental          review      process      for 13 preparing an Environmental Impact Statement, commonly 14 referred to as an EIS, as described in 10 CFR Part 51 15 and      in  the    Interim      Staff        Guidance    augmenting 16 NUREG-1537.
17                  The following presentations provide an 18 overview of the environmental review for the SHINE 19 Application while highlighting the unique aspects of 20 this review.
21                  The  three    novel      issues    that  we    will 22 highlight      today    include      the    staff's    decision      to 23 prepare an EIS, the inclusion of the Department of 24 Energy as a cooperating Agency and the NRC staff's 25 analysis      to    determine        the    range      of  reasonable NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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174 1 alternatives analyzed in the EIS.
2                  And now, I turn it over to Dave Wrona.
3                  MR. WRONA:      Thank you, Jane.
4                  One    of    the      first      steps  in      the 5 environmental      review      process      was    determining      the 6 appropriate methodology for the environmental review 7 and the level of detail for staff findings.
8                  Environmental          reviews      for  licensing 9 actions fall into one of three categories, those 10 identified as categorical exclusions and not requiring 11 further evaluation, those requiring the preparation of 12 an environmental assessment, commonly referred to as 13 an EA and those requiring the preparation of an EIS.
14                  Licensing actions that require and EIS are 15 described in 10 CFR 51.20.              The proposed issuance of 16 a    Construction    Permit      for    a    medical    radioisotope 17 production facility is not specifically listed in 10 18 CFR 51.20.
19                  Such licensing actions would require an EA 20 or an EIS, depending on project-specific activities 21 and site-specific conditions that could impact the 22 actions potential to significantly affect the quality 23 of the human environment.
24                  After    reviewing        SHINE's      environmental 25 report,        the    staff        made        a    project-specific NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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175 1 determination that an EIS would be appropriate to 2 assess        the  environmental        impacts        of  the  proposed 3 action.
4                    This determination was made because of the 5 potential for potential significant impacts and unique 6 considerations of a first-of-a-kind application for a 7 medical        radioisotope      production          facility    using      a 8 unique application of technologies.
9                    The EIS process also allowed for multiple 10 opportunities          for      public      involvement          in      the 11 environmental review.
12                    In the EIS, we evaluated potential impacts 13 from      the    proposed      action,      that      is,  the  proposed 14 construction of the SHINE facility.
15                    Consistent          with        the      Council          on 16 Environmental Quality's regulations implementing NEPA, 17 the staff considered connected or related actions and 18 evaluated the potential impacts from operations and 19 decommissioning.
20                    A discussion of potential impacts from 21 operations          is    also      consistent            with    previous 22 environmental          reviews      conducted        by    the  staff      for 23 Construction Permit Applications, such as the Final 24 Environmental Statements for the Columbia Generating 25 Station and for Arkansas Nuclear One.
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176 1                  Next slide, please?
2                  After publishing the Notice of Intent to 3 Prepare an EIS, the environmental review started with 4 the 60-day scoping period.              Scoping is the process by 5 which the staff identifies the specific impacts and 6 significant issues to be considered in the preparation 7 of the an EIS.
8                  During    this    time,      we    held  two    public 9 scoping meetings in Janesville, Wisconsin to gather 10 input from the public, federal, state, local agencies 11 and tribes regarding issues to consider in the EIS.
12                  Five attendees provided oral statements at 13 the public scoping meetings, including members of the 14 public, a member of the Janesville City Council and a 15 representative from Congressman Mark Pocan's office.
16                  In  addition,        the      staff    received        six 17 written        letters  from      members      of    the  public,        the 18 Wisconsin Department of Natural Resources, the U.S.
19 Environmental Protection Agency and the Forest County 20 Potawatomi community.
21                  The comments were related to a variety of 22 environmental issues including the potential from 23 aircraft or from accidents due to aircraft collisions, 24 potential contamination to groundwater and nearby 25 agricultural        lands,      conversion          of  farmland        and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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177 1 alternative sites and technologies.
2                  The  staff      responded          to  all  comments 3 received      during    the    scoping      period    in  a  Scoping 4 Summary Report. It included relevant information from 5 in scope comments and the draft EIS.
6                  Next slide, please?
7                  Another part of the scoping process was to 8 determine if other governmental agencies had expertise 9 or jurisdiction over the proposed project.
10                  For  SHINE,      two    federal      agencies      were 11 obligated to conduct environmental reviews.
12                  NEC    was      required          to  conduct        an 13 environmental review to decide whether to grant SHINE 14 a Construction Permit.
15                  The Department of Energy, or DOE, was 16 required      to  conduct      an    environmental        review      for 17 providing financial support to SHINE.
18                  Our  coordination        with      DOE  is  another 19 unique aspect of this review.                The coordination with 20 DOE was unique for two reasons.
21                  First, the NRC typically does not consult 22 with DOE to our separate roles and responsibilities.
23                  Second,      the    American        Medical  Isotopes 24 Production Act directs the DOE and the NRC to ensure 25 to the maximum extent practicable that environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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178 1 reviews        for    facilities          to        produce    medical 2 radioisotopes are complimentary and not duplicative.
3                    Therefore,      NRC      and      DOE  developed        a 4 Memorandum        of  Agreement        to    make      effective      and 5 efficient use of federal resources during the review 6 of the SHINE Construction Permit Application.
7                    The goal of the agreement was to develop 8 a single EIS that would evaluate the impacts of NRC's 9 licensing process and the DOE funding process.
10                    The Memorandum of Agreement designates the 11 NRC      as  the  lead    federal      agency      and  DOE    is    a 12 cooperating agency for developing the EIS for the 13 proposed SHINE facility.
14                    Under NEPA, the lead agency, or NRC in 15 this case, has the primary role in preparing the EIS 16 while the cooperating agency, DOE, is responsible for 17 assisting in the development.
18                    Michelle      Moser    will      now  describe      the 19 preparation of the EIS and the staff's conclusions.
20                    MS. MOSER:      Thanks, Dave.
21                    In developing the EIS, the staff reviewed 22 the information included in SHINE's environmental 23 report, visited site, considered scoping comments and 24 conducted an independent review to characterize the 25 environmental        features        at    the      proposed    site        in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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179 1 Janesville, Wisconsin.
2                  The environmental resources described in 3 the EIS includes aspects of both the human and natural 4 environment        such    as    ecological          resources,    water 5 resources        and      the      socio-economic          conditions 6 surrounding the proposed site.
7                  As    Jane    described        this    morning,      the 8 proposed site is currently an agricultural field. The 9 site has been previously disturbed due to decades of 10 agricultural activities and is currently zoned for 11 light industrial use.
12                  The proposed site does not contain any 13 surface        water  features,        threatened        or  endangered 14 species or historic or cultural resources.
15                  Next slide, please?
16                  For the proposed SHINE facility at the 17 Janesville site, the impacts to all resource areas, 18 except for traffic, would be small.
19                  A variety of project-specific activities 20 and site-specific conditions is the basis for the 21 small findings.
22                  For    example,        the      condition    of      the 23 previously        disturbed      site,      the      current    zoning 24 designation for light industrial use, the relatively 25 limited ground disturbance that would occur during NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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180 1 construction, operations and decommissioning, the use 2 of a public water system to obtain and discharge water 3 and adequate controls to ensure that radiological 4 exposures to workers and the public would be within 5 regulatory limits.
6                The impacts to traffic would range from 7 small to moderate based on the noticeable increase in 8 average daily traffic flow.                The addition of up to 9 1,000 trips per day from construction activities and 10 up to 580 trips a day from decommissioning activities 11 at the proposed SHINE site would result in increased 12 traffic volume near the facility.
13                During operations, a slight degradation of 14 service, also known as traffic delays, would occur at 15 an intersection near the facility during peak morning 16 hours of commuting.
17                Slide nine, please?
18                In addition to describing the existing 19 environment and assessing the potential impacts at the 20 proposed      site,    the    staff        assessed    potential 21 alternatives.
22                The need to compare the proposed site with 23 alternatives arises from one of the requirements in 24 Section 102 of NEPA.
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181 1 through its regulations in 10 CFR Part 51 and in its 2 Interim Staff Guidance augmenting NUREG-1537.
3                    The regulations and associated guidance 4 state that an EIS will include an analysis that 5 considers and weighs the environmental effects of the 6 proposed        action,      the    environmental        impacts        of 7 alternatives to the proposed action and alternatives 8 available          for    reducing        or      avoiding    adverse 9 environmental effects.
10                    As part of the EIS, the staff considered 11 the environmental impacts of the no-action alternative 12 or if the NRC denied the Construction Permit.
13                    The staff also examined potential impacts 14 at two alternative sites, Chippewa Falls and Stevens 15 Point.        Both of these sites are in Wisconsin.
16                    In    addition,          the      staff  examined 17 alternative        technologies        to    produce    molybdenum-99 18 which was a unique aspect of the SHINE review.
19                    Next slide, please?
20                    The alternative technologies analysis was 21 novel for the SHINE review because the staff developed 22 a methodology to narrow down the large number of 23 potential alternative technologies given that several 24 entities have proposed new technologies to produce 25 molybdenum-99.
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182 1                  The  proposed        new    technologies      are      at 2 various stages of development and several entities 3 currently produce molybdenum-99.
4                  The Council on Environmental Quality's 5 regulations implementing NEPA provides guidance when 6 a large number of potential alternatives exist.
7                  In such situations, NEPA only requires 8 that an agency analyze a reasonable number of examples 9 covering the full spectrum of alternatives in the EIS.
10                  To  begin      the      alternative      technology 11 evaluation, the staff initially considered the large 12 number of possible alternatives or various methods to 13 produce        molybdenum-99      such      as    currently  existing 14 technology and proposed technologies.
15                  The    staff        initially        narrowed        the 16 alternatives        technology        analysis      to  the    three 17 technologies other than SHINE that DOE's National 18 Nuclear Security Administration awarded cooperative 19 agreements for financial support.
20                  The        National            Nuclear      Security 21 Administration based its decision to award cooperative 22 agreements in part on an evaluation of technical 23 feasibility. Thus, these three technologies appear to 24 be reasonable.
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183 1 because no entity has proposed constructing a new 2 facility in the United States using technology that is 3 currently in use in other countries.
4                Additionally, the staff concluded that the 5 three entities awarded cooperative agreements covered 6 the spectrum of alternatives based on the general land 7 use requirements, power levels and other environmental 8 factors.
9                The three alternative technologies that 10 were selected included neutron capture technology, 11 aqueous homogeneous reactor technology and linear 12 accelerator based technology.
13                The      staff        further        narrowed        the 14 alternatives examined in depth by considering whether 15 sufficient environmental data existed to conduct a 16 meaningful alternatives analysis for each of the three 17 alternative technologies.
18                For  example,        the      staff  looked      for 19 publically available documents that describe the air 20 emissions,      estimated      dose      exposures,    water      use, 21 building      heights      and      footprints      and      other 22 environmental parameters to assess the environmental 23 impacts for each alternative technology.
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184 1 data to conduct a meaningful, in depth analysis for 2 the linear accelerator based technology.
3                  The staff did not identify any publicly 4 available documents with sufficient data to assess the 5 environmental impacts for a reactor using neutron 6 capture or an aqueous homogeneous reactor. Therefore, 7 these two technologies were eliminated from further 8 detailed analysis.
9                  Slide 11, please?
10                  In accordance with 10 CFR 51.105(a), the 11 staff        weighed  the    environmental,        economical      and 12 technical costs and benefits for the proposed action 13 alternative sites, the alternative technology and the 14 no-action alternative.
15                  The  main    costs    included    environmental 16 costs as well as the financial costs of construction, 17 operations and decommissioning.
18                  The main benefits included medical and 19 economic benefits.
20                  Next slide, please?
21                  The staff considered the environmental 22 costs of construction, operation and decommissioning.
23 For the proposed SHINE facility at the Janesville 24 site, the impacts to all resource areas, expect for 25 traffic, would be small. The impacts to traffic would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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185 1 be      small    to  moderate      because        of  the  noticeable 2 increase in average daily traffic flow.
3                    The      staff        determined        that        the 4 environmental impacts would be the same if the linear 5 accelerator based alternative was constructed and 6 operated on the Janesville site.
7                    The    environmental            impacts    at      both 8 alternative sites would be small for most resource 9 areas.        However, the impacts to noise would be small 10 to moderate at both Chippewa Falls and Stevens Point 11 in part because the nearest resident would be closer 12 than at the Janesville site and, therefore, the noise 13 would be more audible to the closest residents.
14                    The impacts to visual resources would be 15 small to moderate at the Stevens Point site because 16 the site and much of the surrounding area is forested.
17 In clearing onsite forests during construction would 18 increase        the  visibility        of      the    new  facility, 19 especially in contrast to the surrounding forested 20 area.
21                    Similar to the proposed Janesville site, 22 the impacts at both Chippewa Falls and Stevens Point 23 would be small to moderate for traffic.
24                    Therefore, the staff concluded that the 25 Janesville          site    would      be    the    environmentally NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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186 1 preferable alternative.
2                  Under    the    no-action        alternative,        no 3 changes would occur to the proposed SHINE site in 4 Janesville, Wisconsin.            The site would remain zoned 5 for light industrial use.              Therefore, impacts on all 6 resource areas would be small.
7                  However, the no-action alternative does 8 not meet the stated purpose and need to provide a 9 medical radioisotope production option that could help 10 meet the need for a domestic source of molybdenum-99.
11                  Slide 13, please?
12                  In terms of the benefits considered, the 13 proposed action would result in several societal, 14 medical and economical benefits.
15                  For example, the proposed action is in 16 accordance with U.S. policy to ensure a reliable 17 supply of medical radioisotopes while minimizing the 18 use of highly enriched uranium.
19                  In    addition,          the        production        of 20 molybdenum-99 would increase availability of medial 21 radioisotopes for U.S. public health needs.
22                  And, lastly, constructing and operating 23 the proposed SHINE facility would result in economic 24 benefits      such    as      tax    revenue        and  employment 25 opportunities        to    communities          located  near      the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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187 1 Janesville site.
2                Based on the small environmental impacts 3 associated with the proposed SHINE facility at the 4 Janesville site and the benefits to the U.S. medical 5 community, the efforts to support U.S. policy to 6 produce a domestic supply of molybdenum-99 using low 7 enriched uranium and the economic tax and employment 8 benefits associated with construction and operation of 9 the SHINE facility, the staff determined that the 10 benefits outweigh the small environmental costs.
11                Next slide, please?
12                In addition to NEPA, the NRC may adjust 13 other regulatory requirements within its EIS.                    For 14 example, the staff conducted a review of potential 15 impacts to the threatened and endangered species as 16 required by the Endangered Species Act.
17                Under this Act, the staff must consult 18 with the U.S. Fish and Wildlife Service to determine 19 whether threatened and endangered species could occur 20 on the proposed site and, if so, if the proposed 21 action would affect such species.
22                The proposed action would have no effect 23 on    threatened  and    endangered        species because      the 24 proposed site is primarily an agricultural field and 25 does not provide suitable habitat for any threatened NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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188 1 or endangered species.
2                  In a letter to the NRC, the U.S. Fish and 3 Wildlife      Service    stated      that    no    federally    listed 4 proposed or candidate species would be expected within 5 the project area and no further action is required by 6 the Endangered Species Act if SHINE constructs the 7 proposed facility on the Janesville site.
8                  Under Section 106 of the National Historic 9 Preservation Act, the staff is required to first 10 determine        whether      historic      properties      would        be 11 affected by the proposed action.
12                  If historic properties would be affected, 13 then the staff determines whether the effects would be 14 adverse.
15                  The proposed action would have no impact 16 on known historic and cultural resources because the 17 staff did not identify any historic and cultural 18 resources eligible for protection under the National 19 Historic Preservation Act.
20                  In July 2015, the Wisconsin Historical 21 Society concurred with the staff's determination that 22 no historic properties would be affected.
23                  Slide 15, please?
24                  On May 11, 2015, staff issued the draft 25 EIS for public comment.              During this comment period, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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189 1 the staff requested input from the public and other 2 federal, state and local agencies regarding the data 3 analyses and conclusion in the draft EIS.
4                  During this comment period, the NRC held 5 two public meetings in Janesville, Wisconsin.                            One 6 member of the public provided an oral statement at the 7 meetings.
8                  In addition, the staff received eight 9 written letters from members of the public, Wisconsin 10 Department        of    Natural        Resources,        the      U.S.
11 Environmental        Protection        Agency,        Peoria  Tribe      of 12 Indians of Oklahoma and from SHINE.
13                  In-scope comments addressed a variety of 14 environmental issues including the potential impacts 15 from        accidents    due    to    aircrafts,        storage        of 16 radioactive        waste,      greenhouse        gases    and  climate 17 change, potential contamination to nearby agricultural 18 lands and alternative sites and technologies.
19                  The staff responded to all comments in the 20 final EIS which was published on October 16, 2015.
21 The staff provides the final EIS based on the in-scope 22 comments and based on newly available information 23 since the publication of the draft EIS.
24                  Next slide, please?
25                  In accordance with 10 CFR 51.105(a), the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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190 1 staff        weighed  the    environmental,          economical      and 2 technical costs and benefits for the proposed action, 3 alternative sites and the alternative technology and 4 the no-action alternative.
5                  Based on the small environmental impacts 6 associated with the proposed SHINE facility at the 7 Janesville site and the societal, medical and economic 8 benefits associated with the proposed SHINE facility, 9 the staff determined that the benefits outweigh the 10 small environmental costs.
11                  Therefore,        in    the        EIS,  the      staff 12 recommends the issuance of the Construction Permit.
13                  Slide 17, please?
14                  The issuance of a Construction Permit is 15 a separate licensing action from the issuance of an 16 Operating License.          If the NRC issues a Construction 17 Permit, 10 CFR part 50 requires that SHINE submit a 18 separate Application for an Operating License.
19                  If SHINE were to submit an Application for 20 an Operating License for a production or utilization 21 facility, the staff would prepare a supplement to the 22 EIS in accordance with 10 CFR 51.95(b).
23                  The supplement to the final EIS would 24 update the environmental review by discussing issues 25 or topics not included in the final EIS and any new NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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191 1 and        significant    information            regarding    matters 2 discussed in the final EIS.
3                  The staff would follow the environmental 4 review process outlined in 10 CFR Part 15 in preparing 5 the      supplement  to      the    EIS,      including    scoping, 6 requesting      comments    on    the    EIS      and  updating      the 7 supplement      to  the    EIS    based      on    public  comments 8 received.
9                  This concludes the staff's remarks in the 10 Environmental Panel.            We are prepared to answer any 11 questions you may have.
12                  CHAIRMAN BURNS:        Okay.        And, what I might 13 ask you to do is do a little bit of shuffle again so 14 we can all see.
15                  And, I'll start off with questions.
16                  I found it interesting, Mr. Wrona, that 17 there was a -- your testimony discussed the question 18 of whether or not an Environmental Impact Statement 19 would have been prepared for this site.
20                  Was there really a serious question that 21 there would not have been an EIS for a project of this 22 kind?
23                  For  example,        if  this      were  a  research 24 reactor, would that have normally required an EIS?
25                  MR. WRONA: The issuance of a Construction NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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192 1 Permit for a research reactor would not, again, be in 2 10 CFR Part 51.20 as required to have an EIS issued.
3                  We look at these on a case by case basis.
4 So, it would depend on what the proposed action is and 5 what is going on at the site where they're proposing.
6                  CHAIRMAN BURNS:          Okay.      So, in sum, you 7 would say that the two major factors or the major 8 factors that led the staff to conclude that an EIS was 9 an appropriate means of addressing our NEPA obligation 10 were what?
11                  MR. WRONA:      It was, for the SHINE case, 12 the unique first-of-a-kind application was one of the 13 things and the main thing that led us to develop an 14 EIS for SHINE.        That was pretty much the main issue 15 for development of an EIS.
16                  CHAIRMAN BURNS:        Okay, all right, thanks.
17                  I think, Ms. Moser, you, in discussing the 18 alternative technologies, one thing I think I heard 19 you say is that the staff excluded from consideration 20 as alternative technologies, technologies used outside 21 of the United States.
22                  I'm trying to understand that because what 23 that      includes,  is    that    basically        using what        is 24 currently the source which an aging research reactors?
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193 1 from further detailed studies.
2                  CHAIRMAN BURNS: Okay, so there isn't some 3 other newer technology that's being considered at this 4 point?        I'm just trying to understand the scope of 5 what -- it was interesting how you said that.
6                  So, basically, what it was, you were not 7 considering production in a research reactor such as 8 is currently conducted is what you're saying?
9                  MS. MOSER:        Correct, outside of the --
10 yes, that is currently occurring outside of the United 11 States and we eliminated that from further study 12 within our alternative technology analysis.
13                  CHAIRMAN BURNS:          Okay.
14                  One of the things you also just spoke to 15 in terms of describing the comments was comments that 16 were      within  scope.      I    presume      were some    of    the 17 comments what you considered out of scope and what 18 would they be?        Where I don't like any of this kind of 19 technology, is that what I should conclude from that?
20                  MS. MOSER:        Yes,      we  received    a    few 21 comments that expressed opposition to the facility 22 which we considered out of scope for the environmental 23 impact statement.
24                  Other out of scope comments included --
25                  CHAIRMAN BURNS: But, why were they out of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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194 1 scope?        They can -- it's fine to be against the 2 facility but you have to have some -- I presume there 3 has to be some content there that is relevant to the 4 considerations we take into account?
5                  MS. MOSER:        Correct.        If it would have 6 described environmental concerns that should have been 7 -- that were within the scope of what we analyzed in 8 the Environmental Impact Statement such as concerns 9 from potential accidents, then that we would have 10 considered        within    scope    and    that      we  would      have 11 analyzed within the EIS.
12                  CHAIRMAN BURNS:          Okay.
13                  You said that there were no historic or 14 archaeological        or      the    impact        on    historic        or 15 archaeological resources wasn't an identified.
16                  You did receive one, maybe two comments 17 from Tribal organizations.                What were the nature of 18 those comments?
19                  MS. MOSER:        Both    of    the  Tribes      that 20 submitted comments to us expressed that they wanted to 21 know additional information if any studies occurred or 22 if there was an inadvertent find of something like 23 human remains, they wanted to be notified.
24                  CHAIRMAN BURNS:          Okay.      So, they want to 25 be      informed    if    further      studies        were    done        or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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195 1 significant remains of some kind?
2                  MS. MOSER:      Well, to clarify, one of them 3 asked for a copy of the study that was conducted 4 onsite.
5                  CHAIRMAN BURNS:          Okay, okay.      All right, 6 thanks.
7                  I wanted -- the last question I have, I 8 want to understand in terms of the assessment of 9 alternative sites and the Chippewa Falls site and the 10 Stevens        Lake  or      Stevens        Point,      thank      you, 11 Commissioner, Stevens Point site.
12                  You  described        and    I    saw also  in    the 13 Applicant's      presentation        that      the    differences      in 14 impacts were moderate or described as moderate with 15 respect to the Stevens Point and Chippewa site.
16                  And, I think you describe it that that 17 became moderate because of noise consideration.                          Is 18 that the only thing that reached your assessment that 19 it would become a moderate impact?
20                  MS. MOSER:          At Stevens Point, it was 21 noise, visual resources --
22                  CHAIRMAN BURNS: Oh, visual, that's right.
23                  MS. MOSER:      -- and traffic.
24                  CHAIRMAN BURNS:          Okay.
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196 1 noise and traffic.
2                  CHAIRMAN BURNS:            But, the traffic, it 3 sounded like the traffic at all three sites --
4                  MS. MOSER:      Exactly.
5                  CHAIRMAN BURNS:          -- is more or less the 6 same?
7                  MS. MOSER:      Yes, at all three sites.
8                  CHAIRMAN BURNS:          What tips over into a 9 moderate        impact  in    terms    of    noise?    Is  it    the 10 population near to the -- you said -- I know you 11 described that whoever has their house nearest to that 12 site is closer than at the Janesville site or the 13 proposed site.
14                  Is it also a factor of population in those 15 areas?
16                  MS. MOSER:      Two main factors drove that.
17 One was, as you mentioned, how close the nearest 18 resident is because that would affect how audible the 19 noise is.
20                  The second factor is what's the change in 21 noise?        So, the amount of noise would be similar 22 across all three sites, but because at the alternative 23 sites, the background noise is less.                  The delta, the 24 change in noise would be more noticeable.
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197 1 primarily during the construction period or demolition 2 period or is it normal operations?
3                    MS. MOSER: Primarily during construction 4 and decommissioning.
5                    CHAIRMAN BURNS:          Okay.      All right, thank 6 you very much.
7                    Commissioner Svinicki?
8                    COMMISSIONER SVINICKI: May I testify, Mr.
9 Chairman, that both Chippewa Falls and Stevens Point 10 and Janesville are very lovely locations.                      And, just 11 as someone who will be traveling to Wisconsin next 12 week,        I  would  commend      to    you    that  the  State      of 13 Wisconsin has a really impressive state park and trail 14 system.
15                    And, to Commissioner Ostendorff, for those 16 of us into cycling, distance cycling, Wisconsin has 17 some of the earliest rails to trails conversions that 18 are paved and really extensive.                        Some of them go 19 through old railroad tunnels.
20                    Now,  I    did    note    that      the  Applicant's 21 photos        of  site  characterizations              showed  everyone 22 bundled up and shivering in the cold.                        The staff's 23 visit in July, those were lovely photos that tell you 24 the beauty, the natural beauty, of the State of 25 Wisconsin and the Janesville area.
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198 1                  This is the environmental panel, so this 2 is all germane to our discussion here.
3                  I actually came at -- I do thank everyone 4 for their presentations and for all of their hard work 5 that is underlying these evaluations that have been 6 done.
7                  To the staff, interestingly, I came at 8 your elective choice to do an EIS from the complete 9 opposite perspective of a question that the Chairman 10 asked you.      An EIS was not strictly required here and 11 given that, one can always elect to do more because 12 there's never anyone who's going to prohibit you from 13 doing the EIS versus the environmental assessment.
14                  How does the staff establish a system of 15 discriminating elements that you don't always default 16 to doing something, doing the EIS, the more involved 17 process?      It does increase the resource investment 18 and, you know, has the potential to increase the time 19 duration of the review process as a whole, depending 20 on how the safety review is proceeding in parallel.
21                  You know, how does the -- what would be 22 backstops      when    the    staff      would      say  yes,        an 23 environmental assessment is indeed the appropriate 24 thing to do if you have the elective choice?
25                  MS. MARSHALL:          One      of our  points      of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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199 1 consideration was how well the staff understood the 2 impacts before performing the assessment.                        Because 3 this      was  a  first-of-a-kind          application        for    this 4 technology, the staff was not certain with what the 5 outcome of the assessment would be.
6                  If  we    had    performed          an  environmental 7 assessment and produced a finding, we would have had 8 to do the Environmental Impact Statement following the 9 assessment.        So, that would have increased the time 10 line.
11                  We also considered what actions we would 12 take which included public involvement even in and 13 environmental assessment and the time lines for either 14 an EA or an EIS came out very similar.
15                  COMMISSIONER        SVINICKI:            That    is      an 16 important point and I appreciate you mentioning it 17 that      an  EA  can    lead    to    an    EIS,    so  it  is    not 18 necessarily an either or.                You may end up doing the 19 Environmental Impact Statement even if you begin with 20 the environmental assessment process.
21                  So, thank you for the answer on that.
22                  Again, the Applicant has discussed the 23 fact that they have a policy of transparency and 24 outreach.        They touched on that in the overview and 25 they touched on it here in this panel with their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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200 1 testimony.
2                  I  would    ask    the  Applicant,    could      you 3 elaborate on your separate and distinct outreach and 4 just creating awareness of the proposed facility and 5 what it would do separate from the staff's outreach 6 under -- to Trial entities under Tribal outreach for 7 the EIS?      Could you discuss any specific outreach you 8 did to the Potawatomi Tribe or to the Ho-chunk Nation 9 and what form that took?              Did you make overtures of 10 your own as the Applicant?
11                  MS. PITAS:      We did.        So, we sent letters 12 to all of the 13 Tribes that I mentioned in my 13 presentation.        And then, when we failed to receive 14 responses from the majority of them, actually made 15 phone calls and, in most cases, left voice mail 16 messages with most of them.
17                  COMMISSIONER SVINICKI:              Okay.
18                  MS. PITAS:      And maybe even all of them.
19 I think probably all of them.
20                  COMMISSIONER SVINICKI:              Okay, thank you.
21                  And, I'll just close by just saying, Jane, 22 you should go to Janesville.              Did you go on the trip 23 to Janesville?        If there was a Christinesville, I 24 would definitely go.
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201 1 during the --
2                COMMISSIONER SVINICKI:              Oh, and he should 3 go to Stevens Point.
4                CHAIRMAN      BURNS:              They    spell        it 5 differently.
6                MS. MARSHALL:        But no, I do hope to go in 7 the future.
8                COMMISSIONER SVINICKI:              Okay. All right, 9 thank you.
10                Thank you, Mr. Chairman.
11                CHAIRMAN BURNS: Thank you, Commissioner.
12                Commissioner Ostendorff?
13                COMMISSIONER        OSTENDORFF:          Well,    since 14 we're still on the travelogue, I think Commissioner 15 Svinicki and I share a common experience every --
16 twice a day, every day, as we drive from Northern 17 Virginia into the NCR via the American Legion Bridge 18 listening to the WTOP Traffic on the Eights or looking 19 at the ways display on our iPhones, is it a fair 20 statement that the traffic in Janesville is less than 21 in this area?
22                COMMISSIONER        SVINICKI:          It  is,    but    I 23 appreciate    that    the    staff      has      looked    at      not 24 replicating the Washington traffic in Janesville, 25 which I don't think any Janesvillian would appreciate.
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202 1                  COMMISSIONER OSTENDORFF: Good, thank you.
2                  I  thought      that      was      the  case,    but      I 3 appreciate your clarification.
4                  So, let me turn to the Applicant and I'm 5 going to ask Katrina question on outreach as well.
6 And, it really gets into the unique nature of this 7 facility.
8                  Certainly, Wisconsin's had experience the 9 Kewaunee Nuclear Power Plant, with Point Beach Regular 10 Commercial Power Reactors.                But here, we're talking 11 about, you know, deuterium bombarding tritium and 12 generating 14 MeV and, you know, neutrons and the 13 whole nuclear physics chain.                And, doing source term 14 is very different from commercial power reactors.
15                  What    can    you      tell      us  about        the 16 understanding from your perspective with the SHINE 17 organization of the local community's appreciation for 18 what      this  is  and    what    it's      not    compared    to    a 19 commercial power reactor?                Does that make sense to 20 you?
21                  MS. PITAS:          It  does.        And,    it's      a 22 difficult question to answer because I think there is 23 a wide range of understanding within the community.
24 I    think    the  community      especially        appreciates      the 25 global impact of the product, medical isotopes, in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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203 1 particular.
2                    We've done our best to develop materials 3 that      are  simple    enough      that      they    increase      the 4 understanding        of  someone      without      an  expert    level 5 understanding of nuclear processes and work hard to 6 bring        those  to    our    outreach        meetings    with      the 7 community.        So, we have posters, brochures.
8                    In  terms    of    understanding        maybe      the 9 hazards of the facility --
10                    COMMISSIONER OSTENDORFF: Well, just like, 11 you know, I think on your slides and the overview 12 panel earlier today talks about the source term being 13 a factor of hundreds less than for existing isotope 14 production reactors elsewhere.
15                    So,  just,      you    know,      looking  at      the 16 relative scale of the radiological source, do people 17 understand that?
18                    MS. PITAS:      Yes, so I think so.          It's one 19 of the key talking points that we use with the public 20 is in comparison to current production methods, the 21 amount of radioactivity produced per useful medical 22 isotope is hundreds of times less than -- yes, people 23 see that as a major benefit and a step forward for 24 global medical isotope production.
25                    COMMISSIONER OSTENDORFF:              Okay. Let me NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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204 1 stay with the Applicant for several questions.
2                You  know,      our    staff        talked  about      the 3 complementary    environmental          impact      statement    work 4 between the NRC staff and the Department of Energy.
5 As far as the SHINE organization's concerned, did you 6 see a fairly consistent approach or did you see 7 evidence that different approaches between NRC type 8 questions and Department of Energy questions or how 9 would you characterize that experience?
10                MS. PITAS:      I'm not sure I know.            I'm not 11 very -- yes, go ahead, we'll call Greg Piefer to the 12 stand.
13                MR. PIEFER:      So, Greg Piefer, still under 14 oath.
15                I think, you know, DOE largely let the NRC 16 process drive the show here and I think the NRC 17 process was very thorough.            I assume there were some 18 negotiations behind the scenes in terms of making sure 19 DOE specific assessments were included in the NRC 20 process.
21                But, you know, I think it worked out 22 pretty well in this case and I think the NRC EIS time 23 line was within sort of the Construction Permit Safety 24 Review time line and so, it didn't new time.
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205 1 knows what would have happened if they had chosen to 2 do an EIS. And so, I think, you know, ultimately, it 3 worked out well in this case.
4                COMMISSIONER OSTENDORFF: Okay, thank you.
5                My final comments relates to NRC staff and 6 goes to Michelle.        Your comments and the Chairman's 7 comments on the alternative technologies, I appreciate 8 it.
9                It seems like the staff has exercised a 10 very commonsense approach.            If there's not something 11 there to evaluate then we shouldn't evaluate it.                    And 12 so, it looks like you all made a judgment call that 13 there was not sufficient evidence to look at some of 14 these other alternative technologies, so I just wanted 15 to comment favorably on the approach being taken.
16                Thank you.      Thank you all.
17                CHAIRMAN BURNS: Thank you, Commissioner.
18                Commissioner Baran?
19                COMMISSIONER BARAN:            Thanks.
20                Michelle,        the      staff's      answer        to 21 pre-hearing question 53 stated that it took climate 22 change into account when examining impacts to the 23 affected resources.          The staff explained that it 24 looked at annual mean temperature increases and the 25 increase in the frequency, duration and intensity of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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206 1 droughts.
2                  I really appreciate that you did that, 3 that the staff did that analysis.                    I think we should 4 be    factoring    in  climate      change        impacts  into      our 5 environmental reviews more often.                    So, I commend you 6 all for doing that.
7                  Can you tell us a little bit more about 8 what you did and how you did it?
9                  MS. MOSER:      Certainly.          In Section 4.2 of 10 the EIS is where we analyzed emissions that could 11 potentially contribute to climate change.                        And, in 12 Section        4.13,  we    conducted        a    cumulative    impacts 13 analysis where we looked at what the overlapping 14 impacts        could    be    from    climate        change  on      the 15 environmental resources that could also be affected by 16 the proposed SHINE facility.
17                  COMMISSIONER BARAN:            Thank you.
18                  I also wanted to follow up on Commissioner 19 Svinicki's question about greater than Class C waste 20 that she asked earlier.
21                  In response to that question, SHINE, you 22 noted        that  under    the    American        Medical  Isotope 23 Production Act, DOE would take title to and dispose of 24 any radioactive waste without a disposal path.
25                  My  question        is,      have    you  had      any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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207 1 discussions with DOE about how this program would 2 work?          Are  they    committing          to  physically    take 3 possession of the waste or make arrangements to store 4 it or dispose of it at another location within a 5 certain time frame?
6                    MS. PITAS: We'd like to call Van Bynum to 7 the stand to talk about that.
8                    CHAIRMAN BURNS:          And, again, state your 9 name and confirm that you've been put under oath.
10                    MR. BYNUM:      My name's Van Bynum and I did 11 take the oath this morning.
12                    COMMISSIONER BURNS:            Okay.
13                    MR. BYNUM:          We've      had  a  number      of 14 discussions with DOE both at NNSA side and the EM side 15 for the lease and take back program. They've provided 16 us a draft contract template for the take back and 17 we're expecting a revised draft coming in January when 18 the program's supposed to be stood up.                      So, there's 19 been extensive discussions with them.
20                    COMMISSIONER BARAN:            Okay. And is this a 21 matter of them taking formal title to the waste or are 22 they physically going to take it off your hands 23 somehow?
24                    MR. BYNUM:        Physically take it off our 25 hands.
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208 1                COMMISSIONER BARAN:            Okay. So, when you 2 all kind of are looking at how long you would expect 3 to      potentially  need    to    store      it    onsite,    you're 4 factoring in that DOE is committing to actually take 5 it offsite for you?
6                MR. BYNUM:      Yes.
7                COMMISSIONER BARAN:              Yes?    And it's a 8 relatively short time frame?
9                MR. BYNUM:      We hope.
10                COMMISSIONER BARAN:                You hope?        Okay.
11 Fair enough.
12                That's all I have.            Thank you.
13                MR. BYNUM:      Thank you.
14                COMMISSIONER        BARAN:          Thank  you,      Mr.
15 Chairman.
16                CHAIRMAN BURNS:          Well, thanks --
17                COMMISSIONER BARAN:            I should just note, 18 I don't have any tourism related questions.                    At some 19 point on this panel, I'm like, wow, when did I join 20 the Wisconsin Tourism Commission?                  But, I'll just --
21                COMMISSIONER SVINICKI:              You should be so 22 lucky.
23                COMMISSIONER        BARAN:            I'm  from      the 24 Chicagoland area.        Wisconsin's lovely.
25                COMMISSIONER SVINICKI:                So, you're from NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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209 1 Chicagoland and you've never vacationed in Wisconsin?
2 You are the only person from Illinois that on a nice 3 weekend is not up there clogging all the highways into 4 Wisconsin.
5                    COMMISSIONER BARAN: I did not say that --
6                    COMMISSIONER SVINICKI: And owning all the 7 prime real estate.
8                    COMMISSIONER BARAN:                I don't have any 9 prime real estate in Wisconsin.                      I have vacationed 10 there,        I just  wasn't,      you    know,      like advocating 11 vacationing there in the same way.
12                    CHAIRMAN BURNS:          And, I engaged in some 13 other -- I told Commissioner Svinicki, I actually 14 represented staff in proceedings in Wisconsin on the 15 La Crosse reactor which is --
16                    COMMISSIONER SVINICKI:              And, I do recall 17 you said it was beautiful there.
18                    CHAIRMAN BURNS:            And, I was beautiful, 19 it's a gorgeous area.
20                    So, any that, we'll have travel brochures 21 as you exit today.
22                    But, I want to thank the environmental 23 panel.
24                    We're going to take about a five, ten 25 minute break here.            Try to be back in about five or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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210 1 six      minutes.      And      then    we'll      have the  closing 2 presentations from both the Applicant and from the 3 staff.
4                    And, for both the Applicant and the staff, 5 I would say if there is any clarification, before your 6 closing statement, if there's any clarification you 7 want to make to the presentations, that would be the 8 time.          We can time to do it that you feel you're 9 prepared to do today.
10                    And, with that, we'll, again, adjourn for 11 about ten minutes.
12                    (Whereupon, the above-entitled matter went 13 off the record at 3:00 p.m.)
14                    CHAIRMAN BURNS:            Well, good afternoon 15 again. This is the closing portion of the hearing and 16 we'll start first with the Applicant and I think, Mr.
17 Piefer, you're going to do -- is there any other 18 supplement that you all wanted to do to your testimony 19 or --
20                    MR. PIEFER:        No, we have no additions --
21                    CHAIRMAN BURNS:          Okay.
22                    MR. PIEFER:        -- or changes.
23                    CHAIRMAN BURNS:          Then please proceed.
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211 1 again for your time, your consideration in this very 2 important matter.
3                    I  did      want    to      offer    thanks        and 4 commendation to the staff for very transparent and 5 straightforward            communications              throughout        this 6 process. I think our team has been very impressed and 7 wanted to let you guys know that.                    So thank you again 8 for      your    time  today      and    really      appreciate        the 9 consideration.
10                    CHAIRMAN BURNS:          Thank you.        Mr. Dean, 11 you're        on for  the    staff,    but    there    may  be    some 12 supplement that the staff would like to make at this 13 point?
14                    MR. DEAN: Yes, thank you, Chairman. Yes, 15 this morning we had I think a few open questions, open 16 issues where we didn't either cleanly answer the 17 question or maybe we left a question open, so we 18 thought it would be beneficial if Steve Lynch could 19 provide you responses to the five particular areas 20 where          we  think      we    needed        to    provide        more 21 clarification.          So if you don't mind, I'll have 22 Steve --
23                    CHAIRMAN BURNS:        Okay.      Mr. Lynch, please 24 proceed.
25                    MR. LYNCH:      Yes, I'll run through these NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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212 1 very quickly.      The first was with respect to the size 2 of aircraft that were analyzed for our review.                      Just 3 wanted to clarify that the staff examined -- there 4 were three main categories of aircraft that were 5 broadly military, small and large.                    And the analysis 6 was probabilistic on this looking at both those types 7 of aircraft that would land at the airport and those 8 that would be passing overhead in the corridors.                        So 9 for this analysis no matter whether the aircraft was 10 landing at the SHINE site, or at the airport across 11 the street, or overhead, if the probability was less 12 than the threshold, it was excluded from examination.
13 The only types of aircraft were two small aircraft, 14 the Challenger 605 and the Hawker 400, that SHINE 15 analyzed as being above the threshold and the facility 16 has been designed to withstand those aircraft impacts.
17                  The second issue we had identified was the 18 natural gas pipelines. To clarify, yes, the staff did 19 look at natural gas pipelines near the SHINE facility 20 and at the SHINE facility.                These are provided in 21 figures both in the staff's SER and SHINE's PSAR in 22 chapter 2.      There's also a table in SHINE's PSAR in 23 chapter 2 that gives distances and sizes of the 24 natural gas pipelines surrounding the facility. While 25 the        sizes  of    the    pipelines          are  proprietary NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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213 1 information, the distances are given.
2                  The next issue I had, I wanted to clarify 3 some        statements    that    we    made        with  respect        to 4 differentiating between the irradiation facility and 5 the      production    facility.          In    our  Interim    Staff 6 Guidance we had initially assumed that the irradiation 7 facility or an irradiation-like facility would be 8 dependent functionally on the production facility in 9 order to perform and make medical radioisotopes.                          So 10 that is why in our guidance we'd initially thought 11 that a single production facility license could be 12 issued for the entire facility.
13                  After reviewing SHINE's application we 14 came      to  the  understanding          that      the  irradiation 15 facility and radioisotope production facility could 16 operate separately and independently, meaning SHINE 17 can irradiate as much uranium as they want at the 18 irradiation facility without impacting the function of 19 the production facility.              They don't even need to be 20 in the same building.              They could be in different 21 states.        So because of that we understood that the 22 irradiation facility is licensed as irradiation units 23 and the production facility is separately licensed as 24 the production facility.
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214 1 distinguishing between commitments and conditions.
2 Items that are identified in SHINE's Corrective Action 3 Program that they provided to the staff and that the 4 staff determined could be reasonably left for later 5 consideration in the final safety analysis report, 6 those represent the regulatory commitments that SHINE 7 has made. The conditions on the other hand are issues 8 that the staff would like more information on during 9 construction.          And we'd like to emphasize that the 10 conditions, unlike the commitments, cannot be changed 11 without prior NRC approval.
12                    And then the final item that I would like 13 to    provide      clarification        on  were    the  differences 14 between the soluble uranium intake concentrations of 15 10 milligrams per week for occupational limits and 30 16 milligrams        for  accident        conditions.          So    that's 17 essentially        it.      We  think      these      two  limits      are 18 compatible and that for an occupational worker if 19 you're        receiving    10  milligrams          per  week    per      the 20 regulations you could receive up to 520 milligrams of 21 soluble        uranium  and    still      be    in  line  with      the 22 regulations each year.
23                    The 30-milligram intake in contrast to 24 that is assuming an acute exposure from a highly 25 unlikely accident, meaning this is an event that has NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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215 1 a 10 to the minus 5 likelihood of occurring over a 2 24-hour period.          So we think the differences between 3 routine occupational exposure versus an acute accident 4 exposure explained the differences and that they are 5 consistent with one another.
6                    And those are all the comments that I have 7 to make.
8                    CHAIRMAN BURNS:        Okay.      Mr. Dean, proceed 9 with your --
10                    MR. DEAN: Thank you. And in light of the 11 previous discussion, I have been to Williamsburg.                            I 12 don't know if that counts --
13                    (Laughter) 14                    MR. DEAN:      Kristinesville and Barantown.
15 I don't know.
16                    The    staff's        review        of  the      SHINE 17 construction permit application supports the national 18 policy objectives of establishing a domestic supply of 19 molybdenum-99. The SHINE review presented a number of 20 unique technical and licensing considerations for the 21 staff.        The timely completion of this review required 22 the expertise, cooperation and dedication of staff 23 throughout        the  agency.          The    thoroughness      of    the 24 staff's        evaluation    is    reflected        by  the  Advisory 25 Committee on Reactor Safeguards' recommendation to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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216 1 issue the construction permit.
2                  I'd particularly like to commend our staff 3 given the fact that this was a first of a kind, unique 4 review and the fact that they were able to accomplish 5 it in a short time frame, within two years.                        And I 6 particularly want to commend the individual on my 7 right, Mr. Lynch, who has been the project manager for 8 the SHINE. He has just done a tremendous job in terms 9 of      overseeing    that.        So    I    wanted    to  take      the 10 opportunity to do that at this time.
11                  The staff evaluated SHINE's preliminary 12 design to ensure sufficiency of information to provide 13 reasonable      assurance      that    the      final  design    will 14 conform to the design-bases. The staff considered the 15 preliminary analysis and evaluation of the design and 16 performance of structures, systems and components of 17 the SHINE facility with the objective of assessing the 18 risk      to  public  health      and    safety    resulting    from 19 operation of the facility.
20                  Structures, systems and components were 21 evaluated to ensure that they would adequately provide 22 for the prevention of accidents and the mitigation of 23 consequences        of  accidents.            And    the  staff    also 24 considered the potential environmental impact of the 25 facility in accordance with the National Environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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217 1 Policy Act.
2                    The objective of the staff's evaluation 3 was to assess the sufficiency of information contained 4 in the PSAR for the issuance of a construction permit.
5 As such, the staff's evaluation of the preliminary 6 design and analysis of the SHINE facility does not 7 constitute        approval    of    the    safety    of  any    design 8 features or specifications.                  Such approval will be 9 made following the evaluation of the final design of 10 the facility as described in the FSAR as part of 11 SHINE's operating license application.                    An in-depth 12 evaluation of the SHINE design will be performed 13 following the staff's receipt of SHINE's FSAR.
14                    Based    on    the    findings      of  the  staff's 15 review as documented in the Safety Evaluation Report 16 and the final EIS, Environmental Impact Statement, and 17 in accordance with 10 CFR Parts 50 and 51, the staff 18 concludes that there is sufficient information for the 19 Commission to issue the subject construction permit to 20 SHINE.        And that concludes my closing remarks.
21                    CHAIRMAN BURNS:            Thank you.      And for 22 closing, any closing questions or remarks, we'll start 23 with Commissioner Svinicki.
24                    COMMISSIONER SVINICKI: Well, again I want 25 to thank everyone for their presentations. And, Bill, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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218 1 I appreciate that you've been to Williamsburg.                      And 2 all I have to say, at the risk of sounding like John 3 Belushi in Animal House, if there's a bear in town, I 4 got one thing to say:        Road trip.          I think we should 5 move immediately.        The Commission make a road trip 6 there.
7                On a more serious note, I think we don't 8 get to this stage in the licensing process or the 9 issuance of a construction permit without tremendous 10 dedication to the task by both the Applicant and the 11 staff, and tremendous professionalism I think was 12 displayed, not only today, but was evident in the 13 description in the engagements both with external 14 parties and with each other that we've heard about in 15 the answers to the questions throughout the mandatory 16 hearing here today.
17                Again, I'd just note for anyone listening 18 unfamiliar with this process, this hearing and the Q 19 & A conducted is not the totality of the record.
20 There is tremendous analytical record that backs up 21 all of the responses that we heard today.                      It is 22 voluminous. And then there were prehearing materials 23 and testimony that was provided to all members of the 24 Commission, which we began with a resumption today 25 that the Commission already knew that, but that was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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219 1 hundreds of pages I think in and of itself.
2                    So  I  thank      again,      especially    looking 3 inwardly        to  the    NRC,    all    of    the    NRC  staff      that 4 contributed.        And that's everyone, both the technical 5 staff, the legal staff, but all those in support roles 6 that make it possible to conduct a hearing like this.
7 And I think that the Commission is well-served to make 8 a very efficient deliberation and hopefully a timely 9 decision on this matter.                Thank you, Mr. Chairman.
10                    CHAIRMAN BURNS:        Thank you.        Commissioner 11 Ostendorff?
12                    COMMISSIONER OSTENDORFF:                Thank you.        I 13 have no questions.            My comments are very similar to 14 Commissioner          Svinicki's          for        SHINE    and        the 15 organization.          I appreciate the professionalism and 16 the attention to detail that you've obviously provided 17 in your application.
18                    To the NRC staff, I am pleased to be part 19 of    an    organization      working      at      looking  at    a    new 20 technology and looking at things that are different 21 from what we've done in the past.                  And so I think that 22 aspect that's been highlighted by many at this table 23 today is very significant.                And being able to take a 24 good look at what our regulations require, what's the 25 spirit and the intent and how to apply those to areas NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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220 1 where perhaps all the Is may not be dotted and all the 2 Ts may be crossed, but in a way to execute our 3 responsibilities in a common sense approach when there 4 may not be complete word-for-word coverage that's 5 identical to what we've dealt with in the past.                          So 6 that's I think a significant accomplishment.
7                  And I do appreciate the work of all the 8 staff, as Commissioner Svinicki noted, across the 9 entire agency.        Well done.
10                  CHAIRMAN BURNS:          Thank you.      Commission 11 Baran?
12                  COMMISSIONER BARAN:            Well, just briefly I 13 want to join my colleagues in thanking the NRC staff 14 and SHINE for all of your hard work throughout the 15 review        of this  application.              We  appreciate      the 16 significant amount of preparation that goes into one 17 of these mandatory hearings, so thank you for all that 18 work.
19                  I think today's hearing's been valuable.
20 It's a valuable part of the process and I thank 21 everyone for their efforts.
22                  CHAIRMAN BURNS:            Thank you.      And I'll 23 conclude by echoing the comments of my colleagues. As 24 well I appreciate the effort, both the Applicant 25 SHINE, as well as the staff have put into it.                    And as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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221 1 Commissioner Svinicki said, we're really just doing a 2 sampling here today.          There's a much deeper record on 3 which the decision making will be based as we consider 4 whether or not to allow issuance of a construction 5 permit under the Atomic Energy Act for this facility.
6 But it reflects a lot of hard work and thoughtful work 7 by both the Applicant and the staff.
8                  I also want to conclude by thanking behind 9 the scenes support we get as well from the Commission 10 Appellate Adjudication and the Office of the Secretary 11 that assure the smooth flow of these proceedings.
12                  And with that, I will mention two other 13 things, and hopefully not be considered Scrooge in 14 announcing them.        And that is that you may expect --
15 the Applicant and staff may expect the Secretary to 16 issue an order with post-hearing questions by about 17 December 22nd.        And the deadline for the responses 18 will likely be December 30th. So you can do it before 19 the new year.
20                  And  then      also    obviously    we've    had      a 21 transcript made of the proceedings here today and the 22 transcript will be provided by the Secretary with an 23 order requesting proposed corrections.                    That order 24 will      probably  issue      around    December    21st  with      a 25 one-week      deadline    for    transcript      corrections        on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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222 1 December 28th.
2                Part    of    the    reason        for that  is    the 3 Commission I think in its -- in my experience, both as 4 general counsel and now returning to the agency in the 5 last year with my colleagues presiding over these 6 proceedings is the Commission is dedicated to making 7 decisions in a timely fashion in these proceedings.
8 And in saying that, I do expect us to issue a final 9 decision promptly with due regard to the complexity of 10 the issues before us.
11                Again, thank you, everyone.              And we are 12 adjourned.
13                (Whereupon, the above-entitled matter went 14 off the record at 3:23 p.m.)
15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of                                  )
                                                  )
SHINE Medical Technologies, Inc.                  )  Docket No. 50-608-CP
                                                  )
(Mandatory Hearing)                        )
CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing ORDER (Setting Deadline for Proposed Transcript Corrections) have been served upon the following persons by the Electronic Information Exchange.
U.S. Nuclear Regulatory Commission                  U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication        Office of the Secretary of the Commission Mail Stop: O-7H4                                    Mail Stop: O-16C1 Washington, DC 20555-0001                          Washington, DC 20555-0001 E-mail: ocaamail@nrc.gov                            Hearing Docket E-mail: hearingdocket@nrc.gov Morgan, Lewis & Bockius, LLP                        U.S. Nuclear Regulatory Commission 1111 Pennsylvania Ave., NW                          Office of the General Counsel Washington, DC 20004                                Mail Stop - O-15 D21 Counsel for the Applicant                          Washington, DC 20555-0001 Paul M. Bessette, Esq.                              Mitzi A. Young, Esq.
Stephen J. Burdick, Esq.                            Catherine E. Kanatas, Esq.
Andrea N. Threet, Esq.                              Edward L. Williamson, Esq.
Mary Freeze, Assistant Audrea Salters, Legal Secretary                    E-mail:
mitzi.young@nrc.gov E-mail:                                            catherine.kanatas@nrc.gov pbessette@morganlewis.com                          edward.williamson@nrc.gov sburdick@morganlewis.com andrea.threet@morganlewis.com mfreeze@morganlewis.com                            OGC Mail Center :
asalters@morganlewis.com                            OGCMailCenter@nrc.gov
[Original signed by Clara Sola ]
Office of the Secretary of the Commission Dated at Rockville, Maryland this 21st day of December, 2015
 
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of SHINE MEDICAL TECHNOLOGIES, INC.                                      Docket No. 50-608-CP (Medical Radioisotope Production Facility)
ORDER (Setting Deadline for Proposed Transcript Corrections)
The Commission held an evidentiary hearing on December 15, 2015, at its Rockville, Maryland headquarters to receive testimony and exhibits in this uncontested proceeding. The hearing transcript is appended to this Order. Pursuant to my authority under 10 C.F.R.
§ 2.346(a) and (j), the parties may file any proposed transcript corrections no later than December 28, 2015. The parties may coordinate their responses and file a joint set of corrections.
IT IS SO ORDERED.
For the Commission NRC SEAL
                                                      /RA/
Annette L. Vietti-Cook Secretary of the Commission Dated at Rockville, Maryland, this 21st day of December, 2015.
 
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
 
==Title:==
Hearing on Construction Permit for Shine Medical Isotope Production Facility Docket Number:    (n/a)
Location:        Rockville, Maryland Date:            Tuesday, December 15, 2015 Work Order No.:  NRC-2982                          Pages 1-222 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
 
1 1                    UNITED STATES OF AMERICA 2                NUCLEAR REGULATORY COMMISSION 3                                + + + + +
4    HEARING ON CONSTRUCTION PERMIT FOR SHINE MEDICAL 5                  ISOTOPE PRODUCTION FACILITY:
6    SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING 7                                + + + + +
8                          PUBLIC MEETING 9                                + + + + +
10                                TUESDAY 11                        DECEMBER 15, 2015 12                                + + + + +
13                      ROCKVILLE, MARYLAND 14                                + + + + +
15                  The Commission met in the Commissioners' 16 Conference Room at the Nuclear Regulatory Commission, 17 One White Flint North, 11555 Rockville Pike, at 9:00 18 a.m., Stephen G. Burns, Chairman, presiding.
19 COMMISSION MEMBERS:
20            STEPHEN G. BURNS, Chairman 21            JEFF BARAN 22            WILLIAM C. OSTENDORFF 23            KRISTINE L. SVINICKI 24 ALSO PRESENT:
25            ANNETTE L. VIETTI-COOK, SECY NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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2 1 NRC STAFF PRESENT:
2            ALEXANDER ADAMS, JR., NRR 3            MARY ADAMS, NMSS 4            MARISSA BAILEY, NMSS 5            GREGORY CHAPMAN, NMSS 6            WILLIAM DEAN, NRR 7            MARGARET M. DOANE, OGC 8            MIRELA GAVRILAS, NRR 9            CATHERINE KANATAS, OGC 10            STEVEN LYNCH, NRR 11            JANE MARSHALL, NRR 12            KEVIN MORRISSEY, NMSS 13            MICHELLE MOSER, NRR 14            JOSEPH STAUDENMEIER, RES 15            CHRISTOPHER TRIPP, NMSS 16            CARL WEBER, NRO 17            DAVID WRONA, NRR 18            MITZI YOUNG, OGC 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 1 APPLICANT AND WITNESSES PRESENT:
2            STEPHEN BURDICK, Morgan Lewis & Bockius 3            RICHARD VANN BYNUM, SHINE Medical Technologies 4            JIM COSTEDIO, SHINE Medical Technologies 5            BILL HENNESY, SHINE Medical Technologies 6            CHRISTOPHER HEYSEL, Information Systems 7                  Laboratories 8            ALAN HULL, Golder Associates, Inc.
9            CATHERINE KOLB, SHINE Medical Technologies 10            TIMOTHY KRAUSE, Sargent & Lundy 11            STEPHEN MARSCHKE, Sanford Cohen and Associates 12            GREG PIEFER, SHINE Medical Technologies 13            KATRINA PITAS, SHINE Medical Technologies 14            ERIC VAN ABEL, SHINE Medical Technologies 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 1                              A G E N D A 2 Overview (SHINE Medical Technologies, 3      Inc.)    . . . . . . . . . . . . . . . . . . . . 14 4 Commission Q & A        . . . . . . . . . . . . . . . . 36 5 Overview (NRC Staff)          . . . . . . . . . . . . . . 55 6 Commission Q & A        . . . . . . . . . . . . . . . . 73 7 Break . . . . . . . . . . . . . . . . . . . . .                      101 8 Safety - Panel 1        . . . . . . . . . . . . . . .              101 9 Commission Q & A        . . . . . . . . . . . . . . .              114 10 Break . . . . . . . . . . . . . . . . . . . . .                      135 11 Safety - Panel 2        . . . . . . . . . . . . . . .              136 12 Commission Q & A        . . . . . . . . . . . . . . .              148 13 Environmental - Panel . . . . . . . . . . . . .                      164 14 Commission Q & A        . . . . . . . . . . . . . . .              191 15 Break . . . . . . . . . . . . . . . . . . . . .                      210 16 Closing Statement by Applicant                  . . . . . . . .      210 17 Closing Statement by Staff              . . . . . . . . . .          215 18 Commission Q & A and Closing Statements . . . .                      217 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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5 1                      P R O C E E D I N G S 2                                                            9:01 a.m.
3                  CHAIRMAN BURNS: I call this hearing to 4 order on a more serious event, but first let me get my 5 script out as we do need to go through a number of 6 things before we begin this hearing.
7                  I want to welcome the audience and those 8 who may be viewing this remotely on line. Welcome to 9 the Applicant, to the Staff, members of the public.
10 And      the  Commission      is    here    today    to conduct      an 11 Evidentiary Hearing on the SHINE Medical Technologies 12 application for a construction permit for a medical 13 radioisotope        production        facility      in  Janesville, 14 Wisconsin.
15                  This hearing is required under Section 16 189A of the Atomic Energy Act of 1954, as amended. And 17 the Commission will also be reviewing the adequacy of 18 the NRC Staff's Environmental Impact Analysis under 19 the National Environmental Policy Act of 1969, which 20 many of us refer to as NEPA.
21                  This is the third so called mandatory or 22 uncontested hearing that the Commission has held this 23 year, but unlike the two previous ones, this one is 24 for a construction permit, not for a Combined License.
25 But the requirements for the necessity of a hearing on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 1 a construction permit is required as I noted under 2 Section 189A.
3                  During the hearing, SHINE and the Staff 4 will provide testimony and witness panels that will 5 provide an overview of the application, as well as 6 address safety and environmental issues associated 7 with the review, and Commission questions will follow 8 each panel. And there will be a rotation of the 9 Commissioners        from      panel      to      panel,  and        the 10 Commissioners may allocate their total time among the 11 panels as each Commissioner sees fit.
12                  In order to issue a construction permit 13 the Commission must make certain specific safety and 14 environmental        findings.        On    the    safety  side,      the 15 Commission will determine whether in accordance with 16 10 CFR 50.35(a), whether the Applicant has described 17 the proposed design of the facility, including the 18 principal architectural and engineering criteria for 19 the design, and whether the Applicant has identified 20 the major features or components incorporated therein 21 for the protection of the health and safety of the 22 public.        Also,  such    further      technical      or    design 23 information as may be required to complete the safety 24 analysis, and those which can be reasonably left for 25 later consideration to be supplied in the Final Safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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7 1 Analysis          Report;      whether        safety        features        or 2 components,          if  any,    that      require        research      and 3 development have been described by the Applicant, and 4 the      Applicant      has    identified,        and    there  will        be 5 conducted          a    research      and      development        program 6 reasonably designed to resolve any safety questions 7 associated        with  such    features        or  components;        and 8 whether        on  the  basis    of    the      foregoing    there        is 9 reasonable assurance that, one, such safety questions 10 will be satisfactorily resolved at or before the 11 latest date stated in the application for completion 12 of the construction of the proposed facility; and, 13 two,      taking    into  consideration          the    site  criteria 14 contained in 10 CFR Part 100, the proposed facility 15 can      be    constructed      and    operated        at  the  proposed 16 location without undue risk to the health and safety 17 of the public.
18                    In making these findings, the Commission 19 will also be guided by the considerations in 10 CFR 20 Section 50.40 which include the Commission's opinion 21 as to whether the issuance of the construction permit 22 will not be inimical to this common defense and 23 security or to the health and safety of the public.
24                    With respect to environmental matters, the 25 Commission will determine whether the requirements of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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8 1 NEPA        Sections  102.2(a),        (c)      and    (e),    and      the 2 applicable regulations in 10 CFR Part 51 have been 3 met. The Commission will independently consider the 4 final balance among conflicting factors contained in 5 the      record  of  the      proceeding          with    a  view        to 6 determining        the  appropriate        action        to  be    taken, 7 determine after weighing the environmental, economic, 8 technical, and other benefits against environmental 9 and        other    costs,      and      considering          reasonable 10 alternatives whether the construction permit should be 11 issued,        denied,    or    appropriately          conditioned          to 12 protect environmental values, and determine whether 13 the NEPA review conducted by the Staff has been 14 adequate.
15                  This meeting is open to the public, and we 16 do not anticipate the need to close the meeting to 17 discuss        non-public      information,          but    if  a    party 18 believes that a response to a question may require a 19 reference to non-public information, then I would ask 20 the party to answer the question to the best of its 21 ability and practicality with information that is on 22 the public record, and file any non-public response 23 promptly after the hearing on the non-public docket.
24                  Before      proceeding,            do    my      fellow 25 Commissioners have anything they'd like to add? Then NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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9 1 we'll proceed with the swearing in of witness. We'll 2 start first with SHINE. I'd ask counsel for SHINE to 3 introduce himself.
4                  MR. BURDICK: Good morning. This is Stephen 5 Burdick from Morgan Lewis & Bockius, also joined by my 6 colleague, Paul Bessette. We are counsel for SHINE.
7                  CHAIRMAN BURNS: Okay. Counsel, would you 8 read the names of the witnesses?
9                  MR. BURDICK: Yes, and if the witness would 10 please stand when I read their name, and then remain 11 standing until the Chairman directs otherwise.
12                  In alphabetical order SHINE's witnesses 13 are Joseph M. Aldieri, Jeffrey M. Bartelme, Richard 14 Van Bynum, James Costedio, William Hennesy, Alan Hull, 15 Catherine Kolb, Timothy P. Krause, Thomas Krzewinski, 16 C. Michael Launi, James W. McIntyre, John B. McLean, 17 William D. Newmyer, Greg Piefer, Katrina M. Pitas, 18 Erwin T. Prater, Louis Restrepo, Eric N. Van Abel, 19 George        F. Vandegrift,      Tamela      B. Wheeler,    Ernest 20 Wright, and Steven L. Zander. Thank you.
21                  CHAIRMAN BURNS: Okay, thank you.
22                  Witnesses, I'd ask you to raise your right 23 hand to take the oath.
24                  Do you swear or affirm that the testimony 25 you will provide in this proceeding is the truth, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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10 1 whole truth, and nothing but the truth?
2                ALL WITNESSES: I do.
3                CHAIRMAN BURNS: Did anyone fail to take 4 the oath? Indicate so, otherwise. No. Thank you. You 5 may be seated.
6                Is there any objection to including the 7 witness list into the record?
8                MS. KANATAS: No objections.
9                CHAIRMAN BURNS: Okay, thank you, counsel.
10                And then with respect to -- we'll proceed 11 in terms of the admission of evidence on behalf of the 12 Applicant. Are there any edits to your exhibit list, 13 counsel?
14                MR. BURDICK: There are no edits.
15                CHAIRMAN BURNS: Okay. Would you read the 16 range of numbers of the exhibits to be admitted?
17                MR. BURDICK: Yes. SHINE has submitted 18 Exhibits SHN-001 through SHN-029.
19                CHAIRMAN BURNS: Okay. And I presume you 20 propose to move those into the record?
21                MR. BURDICK: We move to admit those into 22 the record.
23                CHAIRMAN      BURNS:      Okay. Is there      any 24 objection?
25                MS. KANATAS: No objections.
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11 1                    CHAIRMAN BURNS: Okay, very good. So, the 2 list of exhibits is admitted for the Applicant, SHINE.
3                    Okay. Turning to the Staff, counsel, would 4 you introduce yourself, please.
5                    MS. KANATAS: My name is Catherine Kanatas, 6 and along with my counsel, Mitzi Young, we represent 7 the Staff.
8                    CHAIRMAN BURNS: Okay, great. Would you 9 read the names of the proposed Staff witnesses?
10                    MS. KANATAS: Yes, and if they can --
11                    CHAIRMAN      BURNS:      And    I'll ask  them      to 12 stand. Thank you.
13                    MS. KANATAS: Thank you. Alexander Adams, 14 John Adams, Mary Adams, Stephen Alexander, David Back, 15 Marissa Bailey, Daniel Barrs, Thomas Boyle, Gregory 16 Chapman, William Dean, James Downs, Thomas Essig, 17 Kevin        Folk,  Mirela      Gavrilas,        Mary  Gitnick,    James 18 Hammelman, Shawn Harwell, Christopher Heysel, Gregory 19 Hofer, Robert Hoffman, Anthony Huffert, Steven Lynch, 20 Stephen Marschke, Jane Marshall, Nancy Martinez, James 21 McIlvaine, Diane Mlynarczyk, Kevin Morrisey, Michelle 22 Moser, Thomas Pham, Paul Prescott, William Rautzen, 23 Jeffrey Rikhoff, Michael Salay, Alexander Sapountzis, 24 Raymond Skarda, Soly Soto-Lugo, Joseph Staudenmeier, 25 Christopher Tripp, Glenn Tuttle, Carl Weber, Abraham NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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12 1 Weitzberg, and David Wrona.
2                CHAIRMAN BURNS: Okay, thank you.
3                So, for the Staff witnesses, I'll ask you 4 to raise your right hand.
5                Do you swear or affirm that the testimony 6 you will provide in this proceeding is the truth, the 7 whole truth, and nothing but the truth?
8                ALL WITNESSES: I do.
9                CHAIRMAN BURNS: Did any -- please inform 10 me if any of you decline to take the oath. Okay, you 11 may be seated.
12                Is there any objection to including the 13 witness list?
14                MR. BURDICK: No objection.
15                CHAIRMAN BURNS: Okay. So, proceed to the 16 admission of the evidence on behalf of the NRC Staff.
17 Are there any edits, counsel, to your exhibit list?
18                MS. KANATAS: There are no edits.
19                CHAIRMAN BURNS: Would you read the range 20 of numbers on the list of exhibits to be admitted?
21                MS. KANATAS: Staff exhibits run from NRC-22 001 through NRC-013.
23                CHAIRMAN BURNS: Okay. And I presume you 24 would move to admit those exhibits into evidence.
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13 1 admit them into the record.
2                CHAIRMAN BURNS: Are there any objections?
3                MR. BURDICK: No objection.
4                CHAIRMAN      BURNS:      Okay. And seeing      no 5 objection, the exhibits are admitted. So, thank you 6 for those -- we got through the preliminaries.
7                I think at this point we're ready to have 8 the Overview Panel for SHINE. And for this portion of 9 the proceeding we'll have the Overview Panel from 10 SHINE, and I believe then we have the questions on the 11 Overview Panel, and then we'll have the Staff Panel.
12 So, thank you, counsel.
13                And, again, this is an Overview Panel for 14 opportunity for the Applicant to provide us overview 15 of the application and the proposed project. I would 16 remind the witnesses that you remain under oath. You 17 may assume that the Commission is familiar with the 18 pre-hearing filings on behalf of the Applicant, as 19 well of the Staff. And I would then ask the panelists 20 to introduce themselves. I'll start here.
21                MR. PIEFER: Yes, sir. My name is Greg 22 Piefer. I'm the founder and CEO of SHINE Medical.
23                MR. HENNESY: My name is Bill Hennesy. I'm 24 the Manager of Engineering for SHINE.
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14 1 the Licensing Manager for SHINE.
2                  MR. VAN ABEL: My name is Eric Van Abel.
3 I'm the Engineering Supervisor for SHINE.
4                  CHAIRMAN      BURNS:          Okay. Thank      you, 5 gentlemen. And you may proceed with your presentation.
6                  MR. PIEFER: So, once again, my name is 7 Greg Piefer, and I want to thank the Commission, 8 Commissioners, Mr. Chairman for your consideration of 9 this very important matter. To start it off, I'd like 10 to give you guys a little bit of background on SHINE 11 and our mission as a company.
12                  SHINE Medical Technologies is dedicated to 13 being        the world    leader      in    the    clean,  affordable 14 production of medical tracers and cancer treatment 15 elements commonly known as medical isotopes by the 16 medical community.
17                  We recognize fully that in order to run 18 this business successfully our highest priority needs 19 to be on safety and reliability of the processes used 20 to produce these isotopes. At the end of the day, 21 these products will serve the needs of approximately 22 100,000 patients per day around the globe making this 23 a very, very significant endeavor in terms of health 24 care of patients. Of course, we can't operate the 25 plant at all if we're not focused on safety in our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 house, and so those are the highest sort of values 2 within the company.
3                    Also interesting is that we come with this 4 technology to the market at a very interesting time 5 when      there    is  a  tremendous        amount      of  transition 6 happening in the existing supply chain for these 7 medical isotopes. Currently, the only producer in the 8 Western Hemisphere of any significant volume will be 9 leaving        the  market      permanently          in  2018,  and      the 10 products have a 66-hour half-life, the most commonly 11 used product has a 66-hour half-life, and that creates 12 substantial challenges for U.S. patients here if we 13 need      to  bring    all    of    our    medical      isotopes      from 14 overseas. Next slide, please.
15                    Just a little bit more background on the 16 primary        medical      isotope      that      the  world      uses.
17 Molybdenum-99 decays into a daughter, technetium-99m, 18 and      is    used  in  about    85    percent      of  the  nuclear 19 medicine scans performed globally.
20                    Technetium-99m is extremely versatile. Its 21 chemistry allows it to attach itself to a wide variety 22 of drugs where it acts as a tracer, and essentially 23 allows doctors to see what that drug is doing. It has 24 a 6-hour half-life and so it is very difficult to 25 distribute as technetium, but because it's a daughter NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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16 1 of molybdenum-99 which has a 66-hour half-life, you 2 can distribute it around the globe fairly easily.
3                  Collectively, these procedures make up 4 about 40 million doses on an annual basis, so very, 5 very high volume, and very important to patients all 6 around the world, the U.S. being approximately half of 7 those doses.
8                  The pie chart included on Slide 3 shows a 9 breakdown      of  the    procedures          primarily  that      use 10 technetium-99m. I'm just going to call your attention 11 to two of the slices. The largest slice is labeled 12 myocardial profusion. Myocardial profusion is just a 13 way of saying looking at blood flow through the heart 14 muscle and, in fact, is commonly known as a stress 15 test. If a doctor wants to know where to put a stent, 16 if a patient is having chest pain they'll do this. If 17 they want to see if the heart has been damaged by a 18 heart attack, they'll do this test, so very, very 19 useful when you look at the number one killer of human 20 beings in the United States, cardiac disease. And the 21 number two use is for something called a bone scan 22 which is used to stage cancer. And that is the number 23 two      killer  of  people      in    this      country. So,    very 24 important products, very widely used today, and it's 25 very important that the supply chain remain robust for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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17 1 many, many years to come. Next slide, please.
2                  However, it is not clear that the supply 3 chain will remain resilient on the current track 4 without new production. In fact, it looks like it will 5 not be able to meet the needs, the growing needs of 6 the globe in terms of medical isotope production.
7                  I mention the Canadian reactor is exiting 8 the market permanently in March of 2018, and they 9 actually plan to decommission that reactor, at which 10 time the Western Hemisphere will not have a source 11 barring new entrants coming in. And this is not going 12 to create just a problem over here, but it's going to 13 create a global problem. In fact, the Nuclear Energy 14 Agency        as part  of    the    Organization        of  Economic 15 Cooperation        and    Development        has    been  performing 16 studies on exactly this situation for the last several 17 years, and we've included a small bit of data from the 18 most recent study which shows current demand growth in 19 the green line, and current production capacity in the 20 orangish line. As you see, it kind of dips down when 21 Canada leaves.
22                  I'll note that this demand graph does 23 include something called outage reserve capacity and 24 so, you know, there's a little buffer on what's 25 actually required, but that's important. That's what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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18 1 the market needs in order to operate reliably and 2 insure that patients can get the products they need 3 and manage the occasional outage because the supply 4 chain is on the order of 50 to 60 years old in most 5 cases, the research reactors producing this isotope.
6                So it's a very, very, I think, stressful 7 situation for the medical community right now not 8 knowing where their answers are going to lie in the 9 long term, and that problem creates an opportunity for 10 new technology to come in and sort of change the way 11 we've been making medical isotopes in this country, 12 and really do it in a better way. And that's what we 13 believe we've done here. You're going to hear a lot 14 more about how we plan to do that as the day goes on.
15                But when we developed this technology, 16 we've been working on it since about 2006, we had some 17 core values as a company when we founded the company 18 that really are embodied by the technological approach 19 you're going to hear about. And, obviously, as I 20 mentioned in the beginning, we believe at the very 21 highest level that it is impossible to run this 22 company without protecting the health and safety of 23 our workers, the public, and the environment, so these 24 have been factors in our consideration from day one 25 when we were looking at what technologies to choose NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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19 1 and what approach to go forward on.
2                On top of that, we need to insure based on 3 the short half-life of these products that we can get 4 the product out regularly, on time every time. Again, 5 with 66 hours, you know, there's really no forgiveness 6 for substantial delays. It just means that patients 7 aren't going to get the products they need if you 8 can't deliver. And that's unfortunate if a patient 9 presents with chest pains and a doctor is concerned 10 they may have had a heart attack and has to tell them 11 to come back, you know, maybe in a week and hope you 12 make it, or has to give them an alternative isotope 13 that will leave them radioactive for weeks. Stay away 14 from small children for quite some time. It's just not 15 good for the patients, so we need to get this out 16 every single time.
17                We    also      needed        to  insure      cost-18 effectiveness. We had to insure an approach that would 19 allow us to make medical isotopes that can be bought.
20 You know, it's a time when reimbursement is generally 21 across the board decreasing in the United States, and 22 it's important that a cost-effective technology be 23 developed so that this doesn't become prohibitive in 24 terms of cost for patient access.
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20 1 strong in our minds since the beginning is that it's 2 not necessary to use highly enriched uranium to make 3 medical isotopes; however, it is commonly used around 4 the globe today. So, we designed our process to 5 eliminate the need for highly enriched uranium and, in 6 fact, use only low enriched uranium as part of our 7 process.
8                The risk posed to the U.S. public by the 9 proliferation of highly enriched uranium is extremely 10 high. If there were to be an event, the consequences 11 would be disastrous, and we fully support the U.S.
12 Government's initiatives to remove highly enriched 13 uranium from the supply chain and, in fact, stop 14 shipping it around the world to insure that we have 15 appropriate medical tracers.
16                So, these are all things that drove our 17 mission and drove our values, or drove our technology 18 rather. So, I'm going to just give you a high level 19 view of the technology and how it reflects those 20 values.
21                Fundamentally, the biggest protection that 22 we have is that these systems have been designed to be 23 small, and I'm talking about small in terms of thermal 24 power equivalent. When you look at a SHINE production 25 unit or radiation unit, you'll hear more about this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 throughout the day, the thermal power of one of these 2 systems is on the order of 100 kilowatts when its 3 producing at full tilt. If you were to compare this to 4 a reactor like the NRU which is also producing medical 5 isotopes      today,    that      reactor's        thermal      power 6 equivalent is 135 megawatts, so there's about a factor 7 of 1,000 difference in thermal power from a SHINE-8 based system to a reactor-based system. And that has 9 tremendous      safety    benefits      for    us,  including      low 10 source term and very low decay heat. If we shut one of 11 our systems within hours, just a few hours we're down 12 to about a kilowatt of decay heat, so we're talking 13 about something that's less than a hair dryer. So you 14 don't have a lot of the concerns you would have with 15 loss of power in much larger facilities.
16                In addition to the safety benefits just 17 from the lower source term and lower decay heat, of 18 course, we're producing less radionuclides overall 19 that a much larger reactor would do, and that allows 20 us to use commercial disposal for much, if not all, of 21 our disposal path. It's a great economic benefit and 22 certainty benefit in terms of final disposition of 23 waste products.
24                Secondly, we developed a low enriched 25 uranium target that is not only novel in terms of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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22 1 being aqueous, the target is in a liquid form, but 2 it's also the first target that I'm aware of that is 3 reusable. And the reusability of our target actually 4 gives us a substantial economic advantage.
5                Currently      in    the    supply chain,    metal 6 targets are used, solid targets are placed next to a 7 reactor core. They're irradiated. Much of the uranium 8 does not fission, they're dissolved and the medical 9 isotopes are extracted out, and the rest of the 10 uranium is essentially thrown away. Well, in fact, 11 since it's highly enriched uranium in most of these 12 cases, it's thrown into tanks and very carefully 13 monitored. But the reusable target for us is a major, 14 major improvement.
15                And, finally, the system is driven by a 16 low      energy  electrostatic        accelerator. I  say      low 17 energy, that's about 300 kilovolts, 300 kilo electron 18 volts beam energy. And if you were to compare that to 19 a cyclotron that would be found in a pharmacy today 20 that makes isotopes such as fluorine-18, those are on 21 the order of 10 MeV, Mega Electron Volts, so it's much 22 lower, much simpler accelerator that we're using to 23 drive this target. And that also allows us to operate 24 below criticality.
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23 1 the past and they operate at criticality with control 2 rods.        We've  chosen      for    a    number    of  reasons      to 3 eliminate        criticality      all    together      and  use    this 4 accelerator system to drive the liquid target. And 5 that gives us, again, substantially less waste by 6 eliminating the need for a reactor as the primary 7 neutron source. It is also proven, demonstrated, and 8 fairly cost-effective technology that actually people 9 can come and see if they'd like. It's in our lab.
10                    So,    I      guess      that      concludes        my 11 presentation. I'm going to turn the rest of the 12 overview over to Jim Costedio.
13                    MR. COSTEDIO: Good morning. Next slide, 14 please.
15                    The  SHINE      facility        is  located    on    a 16 previously undeveloped 91-acre parcel in the southern 17 boundaries of the City of Janesville in Rock County, 18 Wisconsin. If you look at the map, the area outlined 19 in red on the southern boundary is Rock County. Next 20 slide, please.
21                    The SHINE facility layout consists of an 22 irradiation facility or the IF, and a radioisotope 23 production facility, or the RPF. The area outlined in 24 blue is the irradiation facility which houses the 25 irradiation units, and the area outlined in red is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 radioisotope production facility which houses the hot 2 cells. The facility is relatively small compared to 3 the size of the parcel. It's a 91-acre parcel, and the 4 facility      is  about      55,000      square    feet  centered 5 approximately in the middle of the parcel. Next slide, 6 please.
7                  The SHINE IF consists of eight subcritical 8 irradiation units which are comparable in thermal 9 power level and safety considerations to existing non-10 power reactors licensed under 10 CFR Part 50. However, 11 due to the subcriticality, the irradiation units did 12 not      meet  the  existing        definition      of  utilization 13 facility in 10 CFR 50.2. To align the licensing 14 process with the potential hazards, the NRC issued a 15 direct final rule modifying 10 CFR 50.2 definition of 16 utilization facility to include the SHINE irradiation 17 units. An irradiation unit consists of a subcritical 18 assembly, a neutron driver and supporting systems.
19 Next slide, please.
20                  The radioisotope production facility is a 21 portion of the SHINE facility used for preparing 22 target solution, extracting, purifying, and packaging 23 moly-99, and the recycling and cleaning of target 24 solution. Based on the batch size of greater than 100 25 grams, the RPF meets the definition of a production NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 facility as defined in 10 CFR 50.2. Next slide, 2 please.
3                  SHINE    submitted        a    construction      permit 4 application in two parts pursuant to an exemption from 5 10      CFR    2.101. Part      one    of    the      application      was 6 submitted        on  March    26,    2013    which      included      PSAR 7 Chapter 2 on site characteristics, PSAR Chapter 19 for 8 the environmental review, and general and financial 9 information. Part two of the application was submitted 10 May 31st, 2013 which provided the remaining PSAR 11 chapters. And then a discussion of preliminary plan 12 for coping with emergencies in accordance with 10 CFR 13 50.34(a)(10) was provided September 25th, 2013. The 14 SHINE facility will be licensed under 10 CFR Part 50, 15 Domestic        Licensing    of  Production          and  Utilization 16 Facilities. Next slide, please.
17                  SHINE used for regulatory guidance and 18 acceptance criteria, SHINE used NUREG-1537 guidelines 19 for preparing and reviewing applications for licensing 20 of non-power reactors, and the Interim Staff Guidance 21 augmenting        NUREG-1537      Parts      1      and  2. The      ISG 22 incorporated relevant guidance from NUREG-1520, a 23 Standard Review Plan for the review of a licensed 24 application for a fuel cycle facility. SHINE also used 25 additional guidance such as regulatory guides and ANSI NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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26 1 Standards in developing the application.
2                  That ends my presentation. I'll now turn 3 it    over    to  Eric    Van  Abel      to    discuss the    SHINE 4 technology.
5                  MR. VAN ABEL: Next slide, please.
6                  Good morning. I want to give a brief 7 overview of the process and technology that SHINE 8 plans on using. In this slide, as Jim showed there, 9 there's two main areas of the production facility 10 building. There's an irradiation facility, an IF, and 11 a radioisotope production facility, an RPF. I'm going 12 to go through the processes in these two areas in the 13 next few slides. Next slide, please.
14                  Here's a general schematic of the overall 15 SHINE process overview. Just to orient you relative to 16 the last figure, the TSV and Irradiation Unit Cell in 17 the left there is part of the irradiation facility, 18 and the other components on this diagram are all part 19 of the RPF.
20                  So, we begin our process in the bottom 21 there at the target solution preparation step. In that 22 process we dissolve uranium in sulfuric acid and 23 produce what we call target solution. That target 24 solution is then moved to a hold tank is which is 25 number 2 on the figure there. There's one of these NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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27 1 hold tanks for each of our eight irradiation units so 2 there's eight hold tanks. Those hold tanks are staging 3 areas prior to the radiation cycle, so in that hold 4 tank we'll measure the uranium concentration, the pH 5 to insure that the parameters are correct to begin the 6 irradiation cycle. And then once we're ready to begin 7 we'll start pumping that solution over to the TSV in 8 discrete batches. We'll fill up the TSV for the proper 9 level and then once the TSV is at the proper level we 10 begin        the irradiation      process        by energizing      the 11 neutron driver which is our accelerator that Greg 12 mentioned.
13                  That accelerator runs for approximately 14 five and a half days. We irradiate the solution, 15 produce medical isotopes of interest in the solution, 16 and then we -- once we're done with the irradiation 17 process we drain that solution to a dump tank located 18 right in the irradiation unit cell.
19                  The solution is held there for a short 20 period to decay, and then once we're ready to process 21 it we transfer it over to the super cell, which is 22 number 4 on the figure there. The super cell is just 23 a larger hot cell that has several processes inside a 24 single hot cell. And the first part of that process is 25 the extraction process. And that's where we actually NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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28 1 separate out the moly-99 from the other isotopes in 2 the solution.
3                    And then most of the time the uranium 4 solution just goes right on to the recycle tank which 5 is    number    5  in  the    figure.      And    there  it's    just 6 recycled back into the process and it goes in a loop.
7 It goes to another hold tank, to another irradiation 8 cycle.
9                    Occasionally, we also send it to the UREX 10 process which is item 6 in the figure there. And 11 that's where we periodically clean up the solution, we 12 remove the uranium from the other fission products 13 using        solvent  extraction        technology      UREX,  and      we 14 recover the uranium and recycle that back into the 15 process. So, we just send that back to the target 16 solution        preparation      steps      and      recreate    target 17 solution again. Next slide, please.
18                    In the irradiation facility, SHINE has a 19 system that couples fusion and fission technology, so 20 we have an accelerator that's fusion-based, deuterium-21 tritium fusion-based accelerator coupled to a fission-22 based subcritical assembly. The little diagram on the 23 right there shows a schematic of that process. In the 24 accelerator        we  accelerate        deuterium      ions  into      a 25 tritium gas target. That results in the production of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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29 1 fusion        neutrons,    14    MeV    fusion        neutrons. Those 2 neutrons than pass through a component we call the 3 neutron multiplier. In that multiplier the yield of 4 neutrons        is  increased      and    then      the neutrons      are 5 transferred          into  the    target      solution.      The    target 6 solution is where the uranium is actually located.
7                    In the target solution there's subcritical 8 multiplication so the fission occurs, it causes more 9 fission but in a subcritical process. And then that 10 fission yields the radioisotopes of interest directly 11 in      the    solution    for    ready      extraction      from      the 12 solution.
13                    There are additional supporting systems 14 including a light water pool system. The entire system 15 is located in a pool similar to a research reactor.
16 The target solution vessel off gas system, as I'll 17 mention in a few slides here, manages the gas products 18 from the fission process. The primary closed loop 19 cooling systems cools the TSV during the irradiation 20 process, and there's a tritium purification system 21 that supplies clean gases to the accelerator for the 22 irradiation.
23                    It's important to note that this process 24 is done at essentially atmospheric pressure. It's a 25 low temperature, low pressure process. These aren't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 highly pressurized, high temperature systems like a 2 power reactor would be. The target solution at the end 3 of the irradiation cycle is simply drained to a dump 4 tank, as I mentioned, right in the irradiation unit so 5 that's a passively cooled, safe-by-geometry tank to 6 store        the  solution.      And    that's      drained  through 7 redundant fail-open dump valves.
8                    The TSV itself is just an annular, a 9 simple        annular  vessel      constructed        of Zircaloy,      a 10 widely used alloy in the nuclear industry. And there's 11 no pumping of the solution while irradiating it. It's 12 just naturally convected inside of the vessel. Next 13 slide, please.
14                    This slide shows just a rendering of the 15 subcritical assembly. The outer vessel in the center 16 there is the subcritical assembly support structure, 17 the SASS. This is a secondary vessel that surrounds 18 the TSV. The TSV is internal to that along with the 19 neutron multiplier. SASS is just there in case there's 20 a leak in the TSV, that solution would be contained 21 inside of that. The dump tank is located directly 22 below it there, and there are dump and overflow lines 23 from the TSV to the dump tank to connect it. Next 24 slide, please.
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31 1 in red on this figure. Directly above that is the 2 accelerator. The accelerator sits on a grating above 3 the pool and the accelerator is in yellow in this 4 picture. It's an electrostatic accelerator, a simple 5 accelerator technology. As Greg pointed out before, it 6 generates fusion neutrons from DT fusion that drive 7 the        fission  process.        When      we    shut  down      the 8 accelerator, the fission process terminates because 9 the subcritical assembly is never at critical.
10                  The tritium purification system is not 11 shown in this figure, but it's also in the irradiation 12 facility. And that system separates gases from the 13 accelerator, so the accelerator as it's operating, 14 it's      mixing  deuterium      and    tritium    together.      The 15 tritium purification system separates those back apart 16 and      resupplies    the    purified      tritium    back  to    the 17 accelerator for continued operation. And the tritium 18 lines for that system and the processing equipment are 19 in glove boxes and double-walled pipe. Next slide, 20 please.
21                  The TSV off-gas system is shown in green 22 on the figure here. That system is directly adjacent 23 to the irradiation unit cells. That system contains 24 the fission product gases that are generated in the 25 TSV during irradiation. It removes iodine from the gas NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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32 1 stream, and also its major function is to recombine 2 hydrogen and oxygen. So as we irradiate the solution, 3 radiolysis of the water generates hydrogen and oxygen, 4 and this system sweeps sweep gas air over the target 5 solution vessel to dilute the hydrogen and send it to 6 a recombiner, and then recombine the water and return 7 that water back to the TSV, so it's just a closed 8 loop.
9                The subcritical assembly, as I mentioned 10 before, is immersed in a light water pool. That pool 11 provides significant radiation shielding and decay 12 heat removal. Next slide.
13                For the irradiation process, when we're 14 ready to begin the irradiation we measure the relevant 15 parameters of the target solution, such as uranium 16 concentration, pH, any other chemical parameters that 17 we need to determine, and then we begin moving the 18 solution is discrete batches over into the target 19 solution vessel. We measure the count rate at each 20 step there and from that we can do the 1/M process 21 that's used in reactors all over the world to predict 22 the critical state of the assembly. And the difference 23 with us is that we increase volume, we predict where 24 the critical state is, and we never go there. We stop 25 5 percent by volume below critical. And that's our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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33 1 highest reactivity point for the system.
2                    And  during        that      process    there        are 3 automatic safety systems that are monitoring and will 4 initiate a shutdown on high neutron flux or primary 5 coolant temperature should the operators not stop the 6 system        before    that.      And    that        would  prevent        a 7 criticality. Next slide, please.
8                    Once we begin the irradiation process we 9 isolate that batch of uranium solution in the TSV so 10 it's a fixed target, fixed batch of solution. We close 11 the fill valves, the redundant fill valves and isolate 12 the      fill    pump  from    the    system.        We  energize      the 13 accelerator,          and    then    we    begin      slowly  supplying 14 tritium to the accelerator and that causes the output 15 of      accelerator      to    gradually        increase,    and      that 16 increase in the neutron output of the accelerator 17 results in increased fission power in the TSV. That 18 fission power results in increased temperature and 19 void fraction in the TSV which the system has very 20 strong inherent negative feedback coefficients so the 21 increase        in  temperature        and  void      fraction    causes 22 reactivity to drop significantly in the system. And we 23 don't do anything to compensate for the reactivity 24 drop. We let the system drive further subcritical.
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34 1 half days, and then following shutdown we drain the 2 solution into that dump tank where it's passively 3 cooled. Normally, we're maintaining the temperature of 4 that pool but should we lose offsite power or active 5 cooling for any reason of the pool, there's sufficient 6 heat capacity in the pool for a temperature rise of 7 only 12 degrees after 90 days without cooling, so it's 8 a large body of water. There's very little decay heat 9 because this is such a small system. Next slide, 10 please.
11                In the radioisotope production facility 12 once we're ready we transfer that solution over to the 13 RPF and there we extract the moly-99. We have a 14 purification process that it then goes to. This is the 15 LEU modified Cintichem process where it's a laboratory 16 scale glassware process that's done in the hot cell 17 just to purify the product. And then we package it and 18 get it ready for shipment to customers.
19                In  the    RPF    there's        also a noble      gas 20 removal system, the NGRS. This system collects those 21 off gases from the TSV off gas systems, the ATSV off 22 gas system stores them, holds them for decay for 40 23 days prior to sampling, and then a filtered monitored 24 discharge to our process vessel vent system.
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35 1 recycling and cleaning the target solution, the UREX 2 process. That's, as I mentioned before, a solvent 3 extraction process that separates the fission products 4 and      plutonium    from      the    uranium.        The  uranium        is 5 recovered        for  reuse      in  the    process.      Next    slide, 6 please.
7                  In the SHINE facility we used engineered 8 safety features to protect public health and safety, 9 and these are principally confinement. It's important 10 to    note    that  our    inventory      in    any  one  of    these 11 confinement areas is approximately 10,000 times less 12 than the radionuclide inventory in a power reactor, so 13 they're much lower inventory which reduces the risk.
14 And also these are low temperature, low pressure 15 processes so there's not a lot of stored energy to 16 encourage        dispersal,      so    there's        lower  dispersion 17 forces which, of course, reduces releases.
18                  The confinement functions themselves are 19 provided by the biological shielding. There's -- over 20 most      of  the  processes        there's        thick  reinforced 21 concrete biological shielding, usually several feet 22 thick        concrete. Isolation        valves      on  the    piping 23 systems, ventilation systems play an important role in 24 the confinement features. As shown in the figure on 25 the right there, that shows you some of our cascaded NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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36 1 ventilation zones. From Zone 1 to Zone 4 there's a 2 pressure gradient with Zone 1 being at the lowest 3 pressure, so any potential contamination is reduced 4 outside of those areas in Zone 1 where radiological 5 materials are normally stored. And in any accident 6 scenario, those areas in red on the figure there are 7 the areas where isolation would principally occur and 8 contain that material should an accident occur. And 9 also, of course, instrumentation and control systems 10 that actuate the confinement features. Next slide, 11 please.
12                  So as described in SHINE's PSAR, we have 13 a preliminary design that shows that we can construct 14 this      facility  to    meet      the    applicable regulatory 15 requirements. We've identified robust engineered and 16 administrative controls to insure that we can protect 17 public health and safety, the environment, and our 18 workers, and that we are certainly designing this 19 plant with safety as our primary criterion. And that 20 concludes my presentation.
21                  CHAIRMAN BURNS: Does that conclude the 22 presentations?
23                  MR. PIEFER: It does.
24                  CHAIRMAN BURNS: Okay, thank you. Starting, 25 we'll have Commissioner questions now. We'll start --
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37 1  I'll start off this round of questioning.
2                  Just to make sure I understand the design 3 facility laid out, each of these individual -- the 4 eight        TSVs,  these      are    essentially      independent.
5 Correct?
6                  MR. VAN    ABEL:    Yes.      Yes,  they    can      be 7 operated independently run. We can run anywhere from 8 zero to eight of them.
9                  CHAIRMAN BURNS: Okay. So, there's no real 10 interconnection between them.
11                  MR. VAN    ABEL:    There      are  some    shared 12 systems, like the ventilation system is common to 13 them. There's a common chilled water system that's 14 supplying chilled water to the heat exchangers.
15                  CHAIRMAN BURNS: Okay.
16                  MR. VAN ABEL: But the individual primary 17 cooling systems are unique for each one.
18                  CHAIRMAN BURNS: Okay, thank you.
19                  A couple of questions. Could you give me 20 an idea of what level of public engagement you had in 21 terms of the site selection process for the facility, 22 and the type of feedback you got from that? I guess, 23 Mr. Piefer, that might be for you.
24                  MR. PIEFER: Yes. I actually would like to 25 call Katrina Pitas to the witness stand.
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38 1                CHAIRMAN BURNS: Okay.
2                MR. PIEFER:        She's      got that    pretty 3 thoroughly. Are you ready?
4                MS. PITAS: I think so.
5                MR. PIEFER: Okay.
6                CHAIRMAN BURNS: Well, come -- Ms. Pitas, 7 come up to the podium here. And what I'd ask you to 8 do, and just for other witnesses, when you come up 9 identify yourself, your position. And I remind you 10 you're -- and I presume you took the oath. Yes, I saw 11 you take the oath, and you remain under oath.
12                MS. PITAS: Thank you.
13                CHAIRMAN BURNS: So, thanks.
14                MS. PITAS: So, my name is Katrina Pitas.
15 I'm the Vice President of Business Development for 16 SHINE.
17                Our site selection process involved 11 18 criteria which I'd be happy to go through, but in 19 terms of public involvement, the individual community 20 governments that we were working with during the later 21 stages of our site selection process were very -- we 22 had a very good relationship with all three of the 23 sites that we considered, the specific sites that we 24 considered. And then once we chose Janesville, that 25 relationship has continued to grow, and we believe we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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39 1 have a very good relationship with that community. And 2 I'd be happy to go into some of the actions we've 3 taken        to insure    a    good    relationship        with      the 4 community, if you'd like.
5                  CHAIRMAN      BURNS:      Well,    I  just  --      yes, 6 briefly.
7                  MS. PITAS:      Sure.      So,  once    we    chose 8 Janesville, we set up twice yearly public meetings 9 that were open to the entire community. They were just 10 informational      sessions        where      Greg    would    give      a 11 presentation on our progress, the type of facility, 12 and      what  the  company      was    aiming      to  do    in    the 13 community. And then we also have recently started 14 giving twice yearly updates to the city council which 15 are open sessions, so that makes a total of four times 16 a year we meet directly with the community. It's open 17 to anyone to ask whatever questions they have, voice 18 concerns. And the result of that has been truly -- a 19 relationship based on mutual respect and trust. So, 20 it's been very positive.
21                  CHAIRMAN BURNS: Thank you very much.
22                  The other question I have goes to the 23 nature of what the application is for, which is a 24 construction permit. As I noted earlier, more recently 25 the Commission has been -- has held hearings on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 Combined      Licenses    which    is    by    intention  a    more 2 comprehensive review, maybe not more comprehensive but 3 it's a broader scope of review because it is actually 4 the construction permit and the ultimate operating 5 license combined.
6                  With  a    construction          permit there      are 7 important design parameters that have to be met, 8 requirements that have to be met. But as with the 9 current generation of operating plants in the U.S.,
10 going through the construction permit process allows 11 some completion of certain design features, updating 12 all that.
13                  Could you give me sort of a feel of, if a 14 construction permit is issued, what are, in effect, 15 the things you would see that need to be worked on 16 from a design perspective before we come to the next 17 phase which would be the operating license. What are 18 the things that are still, in a sense, open? And I 19 don't mean open in a negative way, but it's the idea 20 that the Applicant may have some design issues that it 21 needs to address and to resolve prior to a final 22 determination on operating license.
23                  MR. HENNESY: I'll take this one. This is 24 Bill Hennesy, the Engineering Manager.
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41 1 preliminary design where we've outlined the principal 2 design features and the technology that we're going to 3 use. So, the next phase of design will be to go into 4 detailed design where we'll actually work through the 5 details, the many, many details that are needed to get 6 to the construction stage. So, there aren't any real, 7 other than the research and development which we've 8 outlined separately, there aren't any real issues that 9 we need to do other than just the hard work of 10 engineering that's required to move on.
11                  CHAIRMAN BURNS: Okay. So, you're not --
12    there      aren't    what      I'll      call    big  gaps,      any 13 particularly big gaps in terms of sort of filling in.
14 It's      primarily  the    engineering        work,  getting      the 15 design from paper to the actual facility and all that.
16                  MR. HENNESY: Yes, that's correct.
17                  CHAIRMAN BURNS: Okay, thank you. Thank you 18 very much. Commissioner Svinicki.
19                  COMMISSIONER SVINICKI: Good morning and 20 welcome to all of the SHINE witnesses, the Applicant 21 witnesses that are here today and others who have 22 participated in this very complex undertaking.
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42 1 about.        This  is    a    significant          new  facility      and 2 capability for that kind of a more agricultural and 3 rural area. I appreciate that you have done a lot of 4 community education and awareness of this activity. I 5 might suggest to you that if the construction permit 6 is issued and large-scale construction activities 7 start taking place, I think you might have to cover 8 some of the same territory because that's when the 9 community really becomes engaged and very interested 10 when they start noticing all of that activity. And 11 then they will -- a number of them I'm sure will begin 12 their inquiry into exactly what you're doing there.
13 So, it's good that you've got the structure in place 14 to begin to educate and communicate with people about 15 what it is that you are undertaking.
16                    I  note      also,      this      is  an  overview 17 presentation so I'm going to ask some questions that 18 may or may not have a direct relevance to the findings 19 that the Commission will make in order to make a 20 decision on authorizing the construction permit per 21 se.
22                    You provided in your overview presentation 23 some NEA statistics on the projected growth in the use 24 of the product that would come out of the SHINE 25 facility.        I  don't      believe,        though,    that    those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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43 1 projections give any indication of the great swaths of 2 the globe where people are medically under-served and 3 so it doesn't really capture upon the demonstration of 4 a new technology that doesn't use HEU the potential 5 long term maybe to have more penetration of these 6 types        of  diagnostic      techniques        where  arguably      in 7 medically under-served areas of the globe they could 8 do even greater good than they do in areas that have 9 access to a lot of alternatives, or perhaps more 10 invasive procedures.
11                    So, it is interesting that there is a 12 large public good that comes out of constructing a 13 facility like this. Of course, that cannot have a 14 direct        bearing  on      a  safety        determination.      The 15 facility, you know, either is or isn't going to be 16 safely operated, so we have to set that aside. But in 17 my preparation for the mandatory hearing today on the 18 construction permit I couldn't help but think that if 19 any of the SHINE witnesses are fans of Monty Python, 20 it's the opportunity to say "And now for something 21 completely        different."      So,    the    Chairman  has    made 22 reference to the fact that we've been looking a lot at 23 power reactor mandatory hearings, so this was a chance 24 to work our minds around something that is very 25 different.
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44 1                    It's commendable for the NRC Staff, and 2 I'll make this point in their overview presentation.
3 They've used what I call an adaptive process, meaning 4 there was no part of the Code of Federal Regulations 5 that SHINE or the NRC Staff could turn to and say oh, 6 for this type of medical isotope production, here is 7 the regulatory framework. So, as you look forward 8 there        are  elements      of    your    design      that  are      not 9 complete, there is a research and development program 10 and      plans    that    you    have    to    close    on  technical 11 uncertainties that the NRC Staff has, of course, 12 reviewed. And that is part of their finding is to see 13 that you have plans and programs in place to complete 14 and      answer    questions        about      area    of  technical 15 uncertainty.
16                    But  would      SHINE        assess    --  as      the 17 Applicant, do you assess that this adaptive process, 18 a kind of going to things, guidance, regulations that 19 we have in place, deciding which portions of those 20 standing procedures and regulations were or were not 21 relevant to the technology you were proposing, and 22 then applying that and going through a Request for 23 Additional Information process? Would you say that you 24 found        that  process      workable      to      get  through    this 25 construction permit stage? And what would you offer in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 terms of your confidence in continuing to pursue that 2 kind of adaptive process at the operating license 3 stage? And embedded in that, could you address what 4 percent of design do you think you are complete, if 5 you had to put a number on it?
6                  MR. PIEFER: So, I think the answer is yes, 7 and I'm going to turn it over to Jim to do a little 8 bit more comments on the process.
9                  MR. COSTEDIO: I think the process is very 10 workable. All the way through we've met several times 11 with the Staff, we've had public meetings to work 12 through some of the issues, you know, you talked about 13 that      the code  doesn't      specifically        in  all    cases 14 clearly, I mean, address us, but we were able to work 15 through that during the public meetings with the 16 Staff.
17                  COMMISSIONER        SVINICKI:        Do  you  see      it 18 basically      carrying      forward      into      the  --  if      the 19 construction permit is issued, do you see this same 20 process basically carrying forward in the same form to 21 the operating license phase?
22                  MR. COSTEDIO: Absolutely.
23                  COMMISSIONER SVINICKI: Okay. And would you 24 say then that in terms of uncertainties for you going 25 forward, you do have certain proof of concept and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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46 1 technical issues that you have plans in place to close 2 on. There's also regulatory uncertainty that exists at 3 some level. Would you say regulatory uncertainty or 4 technical and proof of concept uncertainty, which of 5 those would dominate the uncertainty going forward for 6 you, or perhaps it's financial.
7                MR. COSTEDIO: I would think the regulatory 8 uncertainty.
9                MR. PIEFER: Yes, of those two, I would 10 agree. I think the -- we've done enough technology 11 demonstrations at this point, including a recent demo 12 where General Electric made injectable drugs out of 13 our process, and they looked beautiful. So, we feel 14 pretty confident in the technology at this point.
15 There's a few things outstanding in terms of longevity 16 of the plant, et cetera, that are being worked on as 17 we go forward; corrosion studies, for example, that 18 we're going to be interested in finding out the data 19 there. But, you know, timeline and financing, you 20 know, you mentioned financing uncertainty. Those two 21 are tied hand and hand, and so that's another thing, 22 we're in a hurry. We've got to do it right, but 23 obviously given the exit of the reactors we'd like to 24 move as quickly as possible. And up until now, you 25 know, we've been able to move this project forward in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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47 1 a largely serial fashion, which is eliminate risks, 2 perceived risks from investors, and then move forward 3 and get the next slug of money.
4                    COMMISSIONER SVINICKI: Can I ask on that 5 point,        the  draft      construction          permit,  or      the 6 construction permit if issued includes a date by which 7 construction would complete. Do you have a notional 8 time        frame    by    which      you    anticipate      beginning 9 construction? In a non-proprietary basis, is that 10 something you could share in this open meeting?
11                    MR. PIEFER: Yes, I think so. I mean, what 12 does the schedule currently say?
13                    MR. COSTEDIO: Spring of 2017.
14                    MR. PIEFER: Spring of 2017.
15                    MR. COSTEDIO: And we would follow with the 16 OL application about three months later.
17                    COMMISSIONER SVINICKI: Okay. And then the 18 last question I had was, I'm not familiar, though, 19 with the airport facility that would be your nearest 20 facility. Is that a cargo hub, or is it -- what size 21 of aircraft -- how active is that facility? Would you 22 have dedicated flights out of there?
23                    MR. HENNESY:      We    might      have  dedicated 24 flights out of there. That's certainly one thing we're 25 considering,        using    a  carrier        that    would  provide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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48 1 service from that area.
2                    COMMISSIONER        SVINICKI:      Is  the  airport 3 facility currently adequately sized for your projected 4 needs, or are there upgrades to the airport itself?
5                    MR. HENNESY: It would be sized for our 6 needs, yes.
7                    COMMISSIONER SVINICKI: Okay.
8                    MR. PIEFER: It's not used for much other 9 than recreational flying.
10                    COMMISSIONER SVINICKI: I was surprised, 11 frankly, again it was a long time ago, but having 12 lived in an adjacent county, I was surprised that 13 there even was an air facility there. I didn't recall 14 that.        Okay,  thank    you    for    that. Thank  you,      Mr.
15 Chairman.
16                    CHAIRMAN BURNS: Thank you, Commissioner.
17 Commissioner Ostendorff.
18                    COMMISSIONER          OSTENDORFF:      Thank      you, 19 Chairman. Thank you all for your presentations this 20 morning.
21                    I  appreciate        that      my  colleagues    have 22 already highlighted that this is a very different type 23 of hearing than we've had under our Part 52 hearings, 24 so having that philosophical mind set change by your 25 comments was very helpful there, Chairman and for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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49 1 Commissioner Svinicki.
2                    I guess this is a question. I think that 3 Commissioner Svinicki may have asked this, I may have 4 missed the answer, but some question that came up 5 about          the  overall      characterization        of    design 6 completion. What can you say about that?
7                    MR. HENNESY: I'll take that question. We 8 debate this amongst ourselves quite a bit, as you can 9 imagine. The characterization of design complete is 10 variable depending on the systems you're looking at.
11 Some systems are pretty far along like our tritium 12 purification system, and others are still back at 13 conceptual. Where those systems we know we can fill in 14 quickly with, design what we need to, like HVAC. So, 15 overall, I would say the percent design complete is 16 around 15 percent, which I believe is appropriate for 17 being able to say that we've completed preliminary 18 design.
19                    COMMISSIONER OSTENDORFF: Okay. So, let me 20 just stay with you there for a minute on the design 21 piece.          I  appreciate          there's      first-of-a-kind 22 engineering issues here, there's some things that have 23 not been attempted before. What are the top two or 24 three areas, sub-components, is it the TSV, is it the 25 hot super cell? I'm curious as to where do you see the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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50 1 most        difficult  challenges          ahead      on  the    design 2 completion?
3                  MR. HENNESY: We have prototypes built in 4 our lab in Monona, and we're continuing to evolve the 5 TSV design, and the TOGS design, and doing testing on 6 components. And I think that's going on pretty well.
7 I think Eric can comment on that some more.
8                  COMMISSIONER OSTENDORFF: As you answer th 9 is question, can you please maybe give a little more 10 detail on what you have in the form of prototype, 11 mockups, or simulations?
12                  MR. HENNESY: Sure. I'll turn that over to 13 Eric.
14                  MR. VAN ABEL: Yes. We have -- each of 15 these components in that overall process diagram, each 16 of those components has been demonstrated individually 17 either by SHINE, by Phoenix Nuclear Laboratories who's 18 the      accelerator      provider,        or      by  the  National 19 Laboratories. You know, the TSV off-gas system, the 20 one that recombines the hydrogen, that system we have 21 a full-scale prototype in our facility in Monona where 22 we've demonstrated full-scale hydrogen recombination 23 testing flow rates, droplet pickup, various things of 24 engineering interest. We have a tritium purification 25 system prototype in our Monona facility constructed by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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51 1 Savannah River National Lab. We have an accelerator in 2 the Monona facility that we share with Phoenix Nuclear 3 Labs that's demonstrated the full production scale 4 accelerator technology. The TSV, we have a mockup TSV.
5 We can't, obviously, put uranium solution in it, but 6 we have a mockup TSV demonstrating -- that's connected 7 to the TOGS system to demonstrate that that system 8 combined        performance.      And    then      Argonne  National 9 Laboratory is doing experiments on the extraction and 10 purification of our solution, so they've irradiated 11 what they call a mini-SHINE experiment, which is 12 essentially a system very similar to our's from a 13 chemical        standpoint      of    uranyl        sulfate  solution 14 irradiated by an accelerator. They process it through 15 our        same    extraction          technologies,          our      same 16 purification technologies that we plan to use. And as 17 Greg mentioned before, they've shipped product to one 18 of our expected customers and demonstrated that it met 19 the purity specifications that we plan to meet.
20                  COMMISSIONER OSTENDORFF: If you had to 21 draw a comparison between your preliminary design for 22 the      SHINE  facility      and    some    existing      facilities, 23 irrespective        of  location,        are    there    a  couple      of 24 facilities that you think you've borrowed from -- I'm 25 not      talking    about    from    an    intellectual      property NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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52 1 standpoint, but just as far as known processes or 2 procedures?        I'm  trying      to    figure      out  what's      the 3 analogy, if there are any analogies, as to what other 4 existing facilities might be somewhat comparable in 5 some aspects to your's?
6                    MR. VAN ABEL: Yes. So, for the TSV, this 7 is a subcritical assembly, it doesn't go critical, but 8 it shares a lot of the physics and thermal-hydraulic 9 characteristics of aqueous homogenous reactors, AHRs.
10 Those        have  been    built      and      tested      at  several 11 facilities. The SUPO reactor at Los Alamos National 12 Lab      is    one  we  use    a  lot    for      validation.      SILENE 13 reactor, the homogenous reactor experiment done at Oak 14 Ridge, HRE reactor. All these facilities we are using 15 their operational history, transient analysis from 16 them to validate our codes to insure that our codes 17 adequately predict the TSV behavior. Working with Los 18 Alamos        National    Lab    on    that,        so  we  borrowed, 19 essentially,        how    they      ran    their        facilities      and 20 operated those AHRs really to feed the design of the 21 TSV.
22                    The accelerator, as we mentioned, we have 23 a full-scale prototype of that accelerator already.
24 And the LEU modified Cintichem process that we use for 25 purification, that's based -- that originated at the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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53 1 Cintichem facility, which is an NRC -- previously NRC-2 licensed facility that produced moly-99 for commercial 3 sale. There they used a typical solid fuel reactor to 4 irradiate solid targets, but then they dissolved them, 5 and processed them, and purified them similar to our 6 technology, so we've looked at that Cintichem facility 7 and use that technology in our facility, as well, for 8 the processing side.
9                    COMMISSIONER OSTENDORFF: Thank you. That 10 was very helpful. Thank you, Chairman.
11                    CHAIRMAN BURNS: Thank you, Commissioner.
12 Commissioner Baran.
13                    COMMISSIONER BARAN: Welcome. Thanks for 14 being here, and for your presentations.
15                    Following up on this distinction between 16 the construction permit application and the operating 17 license        application,      I'm    interested        in  hearing      a 18 little        bit  about    how    you    decided      what  level      of 19 information to include in the construction permit 20 application. When drafting the application, how did 21 you weigh the benefits of having more issues reviewed 22 by the Staff early in the process against having more 23 flexibility        during    construction,          if  you  were      to 24 receive a construction permit?
25                    MR. COSTEDIO:        Well,        we  provided      the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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54 1 principal design criteria, and the design basis of the 2 structure, systems, and components. From that we were 3 able to do our accident analysis, and the results of 4 the accident analysis shows we're within regulatory 5 limits, within the Part 20 limits. Our definition of 6 safety-related implements those requirements on 10 CFR 7 20 and Part 70.61 for the performance requirements.
8 So, you know, we believe that we've provided the 9 necessary      information      to    obtain      the construction 10 permit.
11                COMMISSIONER BARAN: In the final ACRS 12 letter to the Commission, the ACRS raised seven topics 13 to be further addressed in the application for an 14 operating license. Pre-hearing Question 4, explore 15 this issue, and your response indicated that these 16 topics are not included as commitments in Appendix A 17 of the Safety Evaluation Report. How will SHINE insure 18 that      the ACRS  topics      will    be    addressed  at    the 19 operating license stage?
20                MR. COSTEDIO: All of those topics are 21 included -- we issue what we call Issue Management 22 Reports, which are contained in our Corrective Action 23 Program. And every one of them is being tracked to be 24 included in the operating license application.
25                COMMISSIONER BARAN: Okay, thank you.
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55 1                  Although      the    SHINE      facility  is    not    a 2 reactor,        part  of    the    licensing      basis  for      the 3 construction permit utilizes design principles from 4 the general design criteria for nuclear power plants.
5 Can you clarify the process you use to determine which 6 general design criteria are applicable to the SHINE 7 facility?
8                  MR. HENNESY:        We  reviewed    all    of    the 9 general design criteria as outlined in our PSAR when 10 we were looking at the preliminary design, and the 11 PSAR also contains a description of how each of those 12 GDC would apply to SHINE, or how it's integrated into 13 our design, so we actually reviewed all of them.
14                  COMMISSIONER BARAN: Okay. So, you went 15 through them all systematically and assessed whether 16 each one would apply in concept at least to this 17 facility.
18                  MR. HENNESY: Yes.
19                  COMMISSIONER BARAN: Okay, thank you. Thank 20 you, Mr. Chairman.
21                  CHAIRMAN BURNS: Thank you, Commissioner.
22                  I want to thank the Applicant's panel for 23 their        presentations.      We'll      now    proceed  with      the 24 Overview Panel from the NRC Staff. I'll ask the 25 witnesses please come forward, yes.
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56 1                  Okay. Again, this will be the Overview 2 Panel, or an overview from the Staff Panel with 3 respect to the application. I'm going to remind the 4 witnesses you're under oath, and did you all take the 5 oath?
6                  WITNESSES: Yes, sir.
7                  CHAIRMAN BURNS: Okay. And, again, assume 8 that the Commission is familiar, generally familiar 9 with the pre-hearing filings from the Staff and the 10 Applicant. And I will ask the panelists to introduce 11 themselves. Ms. Gavrilas.
12                  MS. GAVRILAS: Mirela Gavrilas, Division of 13 Policy and Rulemaking in NRR.
14                  MS. MARSHALL:        Jane      Marshall. I'm      the 15 Deputy Director for the Division of License Renewal in 16 NRR.
17                  MR. DEAN: Bill Dean, Director of Office of 18 Nuclear Reactor Regulation.
19                  MS. BAILEY:        Marissa        Bailey. I'm      the 20 Director      for  the    Division        of    Fuel  Cycle    Safety 21 Safeguards and Environmental Review in NMSS.
22                  CHAIRMAN BURNS: Okay, thank you. And let 23 the Staff proceed.
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57 1 morning        to provide      testimony        associated with      the 2 application for a construction permit submitted by 3 SHINE Medical Technologies for a medical radioisotope 4 irradiation and production facility.
5                  What you'll hear from this panel is an 6 overview of the Staff's review methodology, as well as 7 highlighting some of the technical and environmental 8 review aspects of it. Essentially, we'll be setting 9 the stage for the panels that you'll have later today 10 on both the technical and environmental aspects of the 11 review. Go to the next slide, please.
12                  So, I'm not going to spend much time on 13 this slide. I think the SHINE representatives did a 14 very good job in terms of setting the stage for the 15 importance of moly-99 production, benefits of the 16 technetium-99m stable as an important radioisotope for 17 medical diagnostic procedures. I think they also set 18 the stage in terms of how much this radioisotope is 19 used in both the United States and globally, so I 20 think they set a pretty good stage for why it's 21 important that we pursue domestic supply, particularly 22 with the Canadian facility scheduled to shut down in 23 2018, as well as the challenges that have existed at 24 some of the foreign facilities with interruptions in 25 supply because of extensive shutdowns for maintenance NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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58 1 activities and so on. So, I think we have a pretty 2 good case for why it's important domestically that we 3 have      a  moly-99  production        facility.      Next    slide, 4 please.
5                  So,  national        policy        objectives      which 6 support domestic production capabilities really have 7 three major components to them. One is to assure that 8 we have a reliable source of moly-99 production.
9 Secondly, that it's not utilizing highly enriched 10 uranium in producing the moly-99, as well as no market 11 subsidies. Those are three aspects of the national 12 objectives        associated        with      moly-99      production 13 domestically.
14                  We  have      --    DOE's        National    Security 15 Administration has engaged in cost-sharing agreements 16 with        various    organizations,            and    SHINE    Medical 17 Technologies is one of those in terms of helping to 18 develop moly-99 production capability. As the SHINE 19 representatives        noted,      they    plan      on  utilizing        a 20 uranium fission process utilizing low enriched uranium 21 in an aqueous homogeneous reactor, and then chemically 22 separating the moly-99 in a radioisotope production 23 facility.
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59 1 with the national policy, and conforms with the Atomic 2 Energy Act, and all the applicable regulations. Next 3 slide, please.
4                We've been preparing for the SHINE review, 5 and      actually  review      of    any    medical radioisotope 6 facility for some time. Back in 2009, we formed an 7 interoffice working group that contributed substantial 8 technical and regulatory diversity and expertise in 9 terms of developing approaches that we would consider 10 if and when we got a production facility application.
11                Back in 2012, we created a Interim Staff 12 Guidance document that was specifically focused on 13 aqueous homogeneous reactors to support and supplement 14 the SRP or the Standard Review Plan for research and 15 test reactors. And this is the products that the SHINE 16 facilities have utilized in terms of developing their 17 construction application.
18                We've had a number of public meetings with 19 engaged stakeholders. This includes, obviously, the 20 SHINE management and staff, public individuals, as 21 well as federal, state, and local governments. These 22 meetings have been focused on the technical, the 23 regulatory, and the environmental review aspects of 24 the SHINE facility. We also have coordinated our 25 review with federal, state, and local governments. So, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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60 1 for example, NMSA from DOE has been involved, the 2 Environmental Protection Agency, the National Fish and 3 Wildlife        Foundation,      and    the    Advisory    Council      on 4 Historical Preservation. And at the state and local 5 levels, the State of Wisconsin Department of Health 6 Services, and the Janesville City Council has been 7 significantly involved with us in terms of some of the 8 review aspects. Next slide, please.
9                    So, at this point I'd like to turn it over 10 to Mirela who will discuss the Staff's review of the 11 SHINE construction permit.
12                    MS. GAVRILAS: Thank you, Bill.
13                    In  2013,      SHINE    submitted      a  two-part 14 application for a construction permit under 10 CFR 15 Part 50. If granted, the permit will allow SHINE to 16 construct a medical radioisotope production facility 17 in Janesville, Wisconsin. SHINE's application only 18 seeks authorization to construct the proposed SHINE 19 facility; therefore, the 10 CFR Part 50 regulations 20 require less detail than for an operating license or 21 a Combined License application.
22                    The necessary elements of a construction 23 permit application are provided in Section 5034 and 24 include        a  preliminary      design      of    the  facility,      a 25 preliminary        analysis      of    structures,        systems,      and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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61 1 components,      probable          subjects        of    technical 2 specifications,      a    preliminary          emergency    plan,      a 3 quality assurance program, and ongoing research and 4 development.
5                SHINE    will      submit      the  Final    Safety 6 Analysis Report or FSAR with their operating license.
7 The FSAR will include SHINE's final design, plans for 8 operation, emergency plan, technical specification, 9 and physical security plan. Next slide, please.
10                The    Staff's        evaluation        of  SHINE's 11 construction    permit      application          consisted  of    two 12 concurrent reviews. One, of SHINE's Preliminary Safety 13 Analysis Report, or PSAR, and the other of SHINE's 14 environmental    report.      I    will    discuss    the  Staff's 15 safety review, and Jane Marshall will discuss the 16 Staff's environmental review.
17                The Staff's safety review assessed the 18 sufficiency of the preliminary design. This includes 19 the principal design criteria and the design basis of 20 SHINE's proposed medical radioisotope facility. The 21 SHINE facility consists of an irradiation facility, or 22 IF, and a Radioisotope Production Facility, or RPF.
23 Next slide, please.
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62 1 facility      rely    on    novel      and      unique    technology.
2 Therefore,      the  Staff    tailored        its  activities      and 3 coordinated with offices throughout the Agency to 4 insure an informed and efficient review.
5                  SHINE's irradiation facility consists of 6 eight subcritical operating assemblies or irradiation 7 units. Each irradiation unit is a 10 CFR Part 50 8 utilization facility. While not reactors, irradiation 9 units are similar to research reactors.
10                  SHINE's proposed radioisotope production 11 facility      consists    of  three      super    cells  for      the 12 separation of molybdenum-99 from irradiated target 13 solution. The RFP is a 10 CFR Part 50 production 14 facility. However, the RFP has physical and chemical 15 processes similar to existing fuel cycle facilities.
16 For both the irradiation facility and the radioisotope 17 production facility, the Staff used the Commission's 18 regulations        and    existing      guidance      to  determine 19 acceptance criteria that demonstrate compliance with 20 regulatory requirements.
21                  The Staff's safety evaluation for both the 22 irradiation facility and the radioisotope production 23 facility was informed primarily by NUREG-1537 which is 24 the      Standard    Review    Plan    for      research  and    test 25 reactors. The Staff augmented NUREG-1537 with Interim NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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63 1 Staff        Guidance    or    ISG    for      evaluating  aqueous 2 homogenous systems and production facilities. The 3 Staff also assessed the preliminary design to have 4 reasonable assurance that SHINE's final design will 5 conform to the design basis. Next slide, please.
6                    An important part of the Staff's review 7 was to determine what additional technical and design 8 information beyond SHINE's initial PSAR was necessary 9 to support the evaluation of the construction permit 10 application. The Staff issued Requests for Additional 11 Information and SHINE supplemented its application.
12                    After    reviewing        the    application        as 13 supplemented, the Staff found that SHINE provided all 14 the information necessary for the Staff to complete 15 its safety review for the purposes of issuing a 16 construction permit. However, the Staff identified 17 certain areas where additional information is required 18 before construction is complete. The Staff is, thus, 19 recommending construction permit conditions.
20                    The conditions require SHINE to provide 21 periodic updates on the design of certain features 22 related        to    criticality          safety      and  radiation 23 protection. These updates are consistent with 10 CFR 24 50.35. They are intended to confirm that SHINE's final 25 design will conform to the PSAR design basis. For NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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64 1 example, SHINE has proposed a criticality alarm system 2 in the radioisotope production facility. A shielding 3 wall will surround the criticality alarm system. The 4 Staff believes that before construction is complete, 5 SHINE must establish the appropriate shielding wall's 6 thickness because if the shielding is too thick, the 7 alarm system will not perform as required. If the 8 shielding is too think, radiation protection will 9 become a concern.
10                  In instances where additional information 11 may reasonably be left for later consideration, SHINE 12 has made commitments to provide such information in 13 the FSAR. These commitments are listed in Appendix A 14 of the Safety Evaluation Report, or SER. The Staff 15 will      verify  that    necessary        information    has    been 16 provided      during    the    review      of    SHINE's operating 17 license application.
18                  The Staff's SER also initially proposed 19 conditions        related      to    the    Preliminary    Amendment 20 Request process. However, as noted in our answers to 21 pre-hearing questions, the Staff has determined that 22 this process is better suited for construction based 23 on a final facility design. As such, the Staff no 24 longer recommends these conditions. The Staff finds 25 that      the  existing      regulations        in  10 CFR  50    are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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65 1 sufficient        to    accommodate        changes      to  the    SHINE 2 facility as the design matures. Next slide, please.
3                  I will now turn over the presentation to 4 Jane        Marshall    for      an    overview        of    the    SHINE 5 environmental review.
6                  MS. MARSHALL: Thank you, Mirela.
7                  The environmental review for the SHINE 8 construction        permit      application          was  performed        in 9 accordance with the National Environmental Policy Act 10 of      1969,    commonly        referred        to    as    NEPA.      NEPA 11 established        a    national        policy        for    considering 12 environmental impacts and requires federal agencies to 13 follow a systematic approach in evaluating potential 14 impacts, and to assess alternatives to the proposed 15 action.        The  NEPA      process      also      involves      public 16 participation and public disclosure.
17                  10    CFR      Part      51      contains        NRC's 18 environmental regulations which implement NEPA. These 19 regulations describe when the Staff should prepare an 20 Environmental        Impact      Statement        or  EIS. The    NRC's 21 regulations did not require the preparation of an EIS 22 for SHINE's application; however, the Staff determined 23 that an EIS would be appropriate because SHINE is a 24 first-of-a-kind application for medical radioisotope 25 production        facility      with    a  unique      application        of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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66 1 technologies      and    an    EIS    would        allow  several 2 opportunities      for      public      involvement        in      the 3 environmental review process.
4                Ultimately,          the        purpose      of        the 5 environmental review is to identify the environmental 6 impacts        of    constructing,                operating,        and 7 decommissioning the proposed SHINE facility, as well 8 as      alternatives    to    the    SHINE      facility,    and      in 9 combination with the safety review inform the Staff's 10 recommendation to the Commission whether or not to 11 issue the construction permit. Next slide, please.
12                The Staff began the environmental review 13 with a scoping process to gather input from the 14 public, other government agencies, and tribes on the 15 necessary scope for the EIS. The Staff conducted an 16 Environmental Site Audit to view the environmental 17 features at the proposed site and the alternative 18 sites, and met with SHINE's technical specialists that 19 developed the environmental report. The Staff also 20 developed      Requests    for    Additional        Information        to 21 clarify aspects of SHINE's environmental report and to 22 seek additional information not included in SHINE's 23 environmental report.
24                The Staff developed a Draft EIS based on 25 the Staff's independent review, information in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1 environmental report, answers to the Staff's Request 2 for Additional Information, and input received during 3 the scoping process and Environmental Site Audit. The 4 Draft EIS was published for comment in May of 2015.
5 The Staff responded to all comments received in the 6 Final EIS which was published in October 2015. The 7 Staff also updated the Final EIS based on in-scope 8 comments and newly available information. Next slide, 9 please.
10                  The    proposed        site      is  currently        an 11 agricultural field which has been previously disturbed 12 from      decades    of  agricultural          activities,    and      is 13 currently zoned for light industrial use. The proposed 14 site does not contain any surface water features, 15 threatened or endangered or candidate species, or 16 historical or cultural resources. The Staff determined 17 that the impacts to all resource areas except for 18 traffic would be small. The impacts to traffic would 19 be      small    to  moderate      because        of  the noticeable 20 increase in average daily traffic flow. Next slide, 21 please.
22                  I will now turn the presentation over to 23 Marissa        Bailey  to  discuss      the      Staff's regulatory 24 findings supporting its recommendation that SHINE be 25 issued a construction permit.
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68 1                  MS. BAILEY: Thank you, Jane. And I'm on 2 Slide 13, and as Jane mentioned, I'll be discussing 3 the      Staff's  findings      to    support      issuance    of    a 4 construction permit.
5                  Section    103    of  the    Atomic  Energy      Act 6 authorizes        the  Commission        to    issue  licenses      to 7 utilization and production facilities subject to the 8 Commission's regulations. The principal regulatory 9 requirements for utilization and production facilities 10 are in 10 CFR Part 50.
11                  After completing the environmental and 12 safety reviews, the Staff has determined that SHINE's 13 application met the applicable requirements of 10 CFR 14 Parts 320, 50, and 51. Also, because processes and 15 hazards are similar to fuel cycle facilities, the 16 Staff determined the performance requirements in 10 17 CFR 70.61 can be used to demonstrate adequate safety 18 for the radioisotope production facility. Slide 14, 19 please.
20                  The  Staff's      review      supports  the    four 21 findings      in  10    CFR    50.35      for    issuance    of      a 22 construction permit. The first finding is that the 23 Applicant has described the proposed design of the 24 facility. The Staff used 10 CFR 50.34(a) and our 25 guidance      to    evaluate        the    sufficiency      of      the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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69 1 preliminary design making sure that SHINE's proposed 2 design basis and criteria are consistent with policy 3 regulations and guidance.
4                  SHINE committed to design the facility to 5 meet the operational safety requirements in 10 CFR 6 Part 20, and the accident consequence and likelihood 7 criteria in the Interim Staff Guidance augmenting 8 NUREG-1537.          SHINE        designated          safety-related 9 structures,        systems,      and    components      that  will      be 10 provided for the protection of the health and safety 11 of the public.
12                  The second finding is that the Applicant 13 has identified technical or design information that 14 can be reasonably left for the Final Safety Analysis 15 Report.        The  Preliminary        Safety      Analysis    Report 16 identified        such  information.            This  includes      the 17 security        and    safety      emergency          plans,  facility 18 operating procedures, and certain design information 19 that SHINE committed to provide in the Final Safety 20 Analysis Report.
21                  The third finding is that the Applicant 22 has identified safety features that required further 23 research and development, and SHINE has done that.
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70 1 precipitation studies. These tests are being performed 2 by      Oak    Ridge  and    Argonne      National      Laboratories 3 respectively.
4                    The fourth finding is, one, for those 5 safety questions and SHINE's research programs, Staff 6 has reasonable assurance that SHINE will be able to 7 complete the research programs before the latest date 8 of construction. And, two, taking into consideration 9 the site criteria contained in 10 CFR Part 100, the 10 proposed facility can be constructed and operated 11 without undue risk to the public. And with respect to 12 that fourth finding, SHINE stated that the latest date 13 of their construction would be December 31, 2022.
14 Based on the schedule SHINE has given us, we're 15 expecting that the research programs will be completed 16 before        this  date.      Also,    the      additional    permit 17 conditions related to criticality safety and radiation 18 safety must be satisfied before the completion of 19 construction.
20                    The site criterion Part 100 applied to 21 power reactors and testing facilities, and not to 22 SHINE's,        but  the    Staff      considered      similar    site-23 specific conditions and external events. The Staff's 24 review confirmed that the radiological releases during 25 normal and abnormal conditions will be within the 10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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71 1 CFR Part 20 dose limits. Thus, we find that the 2 proposed facility can be constructed and operated at 3 the proposed location without undue risk to the health 4 and safety of the public.
5                    Additionally, the Staff concludes that for 6 the purpose of issuing a construction permit, it 7 conducted a thorough and complete environmental review 8 sufficient        to  meet    the    requirements        of  NEPA      and 9 adequate to inform the Commission's action on the 10 construction permit request. Slide 15, please.
11                    Based    on    these      findings,      the    Staff 12 concludes that there is sufficient information for the 13 Commission to issue the subject construction permit to 14 SHINE as guided by the following considerations in 10 15 CFR      50.40    and  50.50. First,      there      is  reasonable 16 assurance that the construction of the SHINE facility 17 will not endanger the health and safety of the public, 18 and that construction activities can be conducted in 19 compliance with the Commission's regulations.
20                    Second,      SHINE        is      technically        and 21 financially qualified to engage in the construction of 22 its      proposed      facility.      Third,      the    issuance      of    a 23 construction permit for the facility would not be 24 inimical to the common defense and security, or to the 25 health        and  safety    of  the      public.      Fourth,    after NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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72 1 weighing the environmental, economic, technical and 2 other benefits of the facility against environmental 3 and other costs and considering reasonable available 4 alternatives, the issuance of this construction permit 5 is in accordance with Subpart A of 10 CFR Part 51, and 6 all applicable requirements have been satisfied. And 7 fifth,        the  application        meets      the  standards      and 8 requirements          of    the    Atomic      Energy    Act  and      the 9 Commission's regulations, and that notifications to 10 other agencies or bodies have been duly made. Slide 11 16, please.
12                    The Staff will discuss novel aspects of 13 its        review    of    the    SHINE      construction      permit 14 application. Safety Panel 1 will discuss the unique 15 licensing considerations. Safety Panel 2 will follow 16 with details of the Staff's accident analysis. And, 17 finally,        the  Environmental          Panel    will  provide      a 18 summary          of    the      process        for      developing        the 19 Environmental Impact Statement.
20                    This concludes the Staff's remarks in the 21 Overview Panel. We're prepared to respond to any 22 questions you may have at this time. Thank you.
23                    CHAIRMAN BURNS: Okay. I want to thank the 24 Staff Panel. We'll begin this round of questioning 25 with Commissioner Svinicki.
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73 1                    COMMISSIONER SVINICKI: Well, good morning, 2 and thank you to the NRC Staff witnesses, and all the 3 NRC Staff that contributed to the review which is the 4 topic of our evaluation and consideration here today.
5                    I should have been born in Missouri, I 6 guess, because I'm the kind of person that I don't 7 really judge things by what people tell me they're 8 capable of, or what they say they plan to do, but what 9 they actually perform, how they actually perform, and 10 what they actually do. You know, the Chairman was 11 talking in his opening remarks about some of the 12 significant licensing work that the NRC Staff has 13 undertaken this year. We've had a number of mandatory 14 hearings, and there are many tens of thousands of NRC 15 Staff        hours  that    go  into      that      review, not    just 16 licensing        staff,    but    legal,      and    a  lot of    other 17 support, organization support that work.
18                    I think if we look at, in particular, 19 Watts Bar 2 operating license and in the Staff's work 20 in support of the findings they've made for issuance 21 of this construction permit, it's an interesting thing 22 has happened. And, again, I -- you know, these days 23 with the news such as it is, I'll turn over every rock 24 and look for some good news, so you can fault me for 25 that, if you want. But there are many questions being NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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74 1 asked about the NRC's potential readiness to look at 2 novel reactor technologies. And I think if we looked 3 at the kind of work and adaptation and agility that 4 had to be demonstrated in the Watts Bar 2 history 5 which had a very unique history in terms of the run-6 up, the many decades run-up to the issuance of that 7 operating license. And then if we complement that with 8 the      Staff's  work    here      in    looking  at the    SHINE 9 construction permit application, but ultimately, also, 10 you're looking forward towards the operating phase and 11 making the safety and environmental determinations 12 that you will need to make there.
13                  I  think      it    demonstrates    to      those 14 skeptical, or maybe those who feel that the NRC's 15 approach and regulations and guidance indicates a very 16 linear and rigid approach to licensing new and novel 17 things. I think both of those licensing activities 18 demonstrated significant ability to take a regulatory 19 framework, existing guidance, maybe complemented by 20 some new Interim Staff Guidance and take that and kind 21 of wrap it around the thing that's in front of you and 22 say what are the relevant and appropriate parts, and 23 how do we do that? And, often, you haven't taken years 24 and years worth of trying to develop the little bits 25 that you need to augment support.
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75 1                  Mr. Dean did mention that the Staff has 2 been        preparing    itself      for      a    medical  isotope 3 application, but the truth of the matter is, it could 4 have taken a lot of different forms. There's -- it 5 could have been vastly different, so what the Staff 6 needed to have in place is something that they could 7 innovate and adapt, and tailor to the thing in front 8 of it. And I think, at least to this stage of the 9 process, and there are quite a few issues, might get 10 a    little    tricker    in  the    operating      license    phase 11 because you've got to come to finality on some complex 12 issues. But that being said, the reason I asked the 13 Applicant in the Overview Panel about getting some 14 calibration on their view of regulatory uncertainty is 15 that when you're inside NRC, you often walk around --
16  we walk around with greater familiarity, perhaps, 17 with the regulatory system, but maybe as a result, a 18 greater confidence in the ability to on our feet do 19 adaptation and innovation, and tailor that particular 20 regulatory framework to whatever is presented to us 21 for review and approval. And I think that we've done 22 that here.
23                  So, having asked the Applicant how did 24 this adaptive process work from their standpoint, I 25 think I got a fairly positive response on that. How NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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76 1 would the Staff answer that same question? Do you 2 think        that  this    taking      the      existing  regulatory 3 framework guidance and then adapting it, determining 4 relevance of various provisions within the framework, 5 do you think that that worked well to this stage, and 6 is    your    confidence      high    that      that will  continue 7 through the remainder of the review? Again, where you 8 will be required to meet the higher bar of coming to 9 closure and finality on some open issues that right 10 now you can, in essence, to use a bad word, punt those 11 off to the operating license stage.
12                  MR. DEAN: So, thank you for the remarks, 13 Commissioner. And I would agree with you, I think the 14 Staff has shown a high degree of flexibility and 15 agility in terms of how they have managed this review 16 activity.
17                  I think one of the important things for 18 us, and maybe Mirela can add something to this, is 19 having a sense of commitment on the part of the 20 Applicant, so that it was worthwhile to invest what we 21 needed to do in order to be at the stage that we're at 22 to be able to conduct the review. I think having some 23 predictability and confidence in that certainly helps 24 us move forward in a way that would allow us to apply 25 all the resources that we did. For example, to develop NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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77 1 the ISG on the aqueous homogenous reactor, I think was 2 an important development given the fact that we had 3 confidence      that  there      would      be    something    coming 4 forward from SHINE. Mirela, do you have anything to 5 add?
6                MS. GAVRILAS: Yes. I can add to that, and 7 I certainly agree what Bill said, that having the 8 interactions with SHINE throughout the process through 9 public meeting was very helpful. But getting back to 10 your original statement, indeed, the Staff does have 11 some confidence in the regulatory framework, and that 12 starts with we know that Part 50 is applicable to 13 irradiation facilities and to production facilities.
14 We know that the irradiation facilities, while they're 15 indeed novel to us, they look like our research 16 reactors, and we have experience with a spectrum of 17 research reactors that exhibit a lot of variability.
18 We have experience with -- I think just before this 19 meeting I was told 12 homogeneous aqueous research 20 reactors,      so  even    there      we    have    the  experience 21 necessary.
22                On the side of the production facility, we 23 have experience with Cintichem. Granted, that was 24 under Part 70, but we have the West Valley facility 25 that was actually licensed under Part 50. So, what the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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78 1 Staff did is, we took the guidance that we had for 2 these -- for research and test reactor, the NUREG-1537 3 which is our Standard Review Plan, augmented it with 4 ISG that captured liquid homogeneous reactors, and the 5 production facilities and came up with a framework 6 that was suitable for SHINE.
7                COMMISSIONER SVINICKI: To build on that, 8 and this is my final question. Maybe this will be a 9 little tricky, so bear with me. Would the Staff assert 10 that the decisions that you've made to this point on 11 which portions and provisions within those portions of 12 our regulations are relevant to your review of this 13 technology      on    the      safety        side?    Are      those 14 determinations you think final, or subject to change?
15 I guess what I'm asking is, as you move towards 16 closure in areas that you or the ACRS has suggested 17 bear additional work, criticality comes to mind, other 18 things where we have to adapt the framework to the 19 highly novel aspects of what we're looking at and make 20 a final safety determination. Do you think you might 21 determine that some section of the CFR that you 22 previously    just    weren't      even      engaging  with      the 23 Applicant on, you might suddenly go, you know, we 24 didn't really look there earlier, but based on the 25 path that this technical issue is taking, we now think NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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79 1 that some new provision of the regulation, you're 2 going to have to demonstrate that you meet some 3 requirement there. Do you think that that's likely or 4 unlikely?
5                MS. GAVRILAS: I can try to answer that, 6 and      maybe  I'll  need    help      on    that. So,  for      the 7 construction permit we feel we're done, so basically 8 there's nothing that is needed. Looking forward to the 9 operating      license,    that's      going      to be  our    first 10 priority, to look at the regulations and see what, if 11 anything,      will  need      to    be    adapted,    be    it      by 12 rulemaking, by order, licensing conditions. We're 13 going to think what's best for the framework to be 14 able to accommodate the operating license review. And 15 we already know that there are some things that impact 16 moly production facilities. For example, the work on 17 material characterization under 74, the rulemaking 18 there is going to be relevant to moly producers.
19 There's security work under Part 73 that's going to be 20 relevant to them. We know that we'll need to look 21 closely at operator licensing because operators might 22 be needed not just for the utilization facility, but 23 also for the production facility, so we'll need to 24 scrutinize the regulation. So, we know we have some 25 work to do going forward.
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80 1                    As  far      as    your      question    for      the 2 technology, we haven't necessarily seen something in 3 the regulation that might need to be changed. It's 4 more the administrative procedural, not the technology 5 itself that is worrying us right now going forward.
6                    COMMISSIONER SVINICKI: I need to ask a 7 follow-up based on that answer. Thank you for that 8 answer.
9                    If we look at the broad purposes of why an 10 agency such as our's reviews and issues a construction 11 permit, there is an element of wanting to identify 12 issues so that irreversible or very difficult to 13 reverse decisions are not made in the construction of 14 the facility; that, you know, you want some sense of, 15 if constructed in accordance with the construction 16 permit that we would issue, there would be high 17 confidence that if other issues are resolved you could 18 operate that facility at some point without needing to 19 chip      out  a  4-foot      thick    concrete      wall  and      make 20 fundamental changes. So, what is the Staff's level of 21 confidence in terms of the identification of relevant 22 regulations that you just described in your previous 23 answer?        Do  you  think    that      that      lends  additional 24 uncertainty        going    forward      to    the    probability        of 25 successful issuance of an operating license in terms NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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81 1 of physical rework of what it is that they're going to 2 construct? I know the potential always exists. I'm not 3 asking you if it's zero. I'm asking you, you know, do 4 you      have    like    at    least    a    reasonable      sense      of 5 confidence that you've identified issues that have the 6 potential for causing substantial rework?
7                    MS. GAVRILAS: So, perhaps what would help 8 is an example on where we set the bar for what's 9 sufficient for construction permit, as opposed to what 10 the expectation is for an operating license. And the 11 bar was, we heard SHINE speak earlier about hydrogen 12 control. So, hydrogen control is a perfect example, 13 because        the  physics.      In    other        words,  what      the 14 concentrations          are    where    deflagration        becomes      a 15 concern are known. The production rate of hydrogen is 16 known.        Our    models,      we    have        well    established 17 uncertainties in those models. We can bound them.
18                    Furthermore,          what's        also  known        is 19 mitigation technology for that. For example, passive 20 autocatalytic recombiners, I think SHINE mentioned 21 those, igniters. There's technology to mitigate the 22 broad range of hydrogen production, so we know that.
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82 1 to us on what they intend to use, we have confidence 2 that        the  outstanding        technical        issues  have      a 3 reasonable chance of being addressed.
4                  COMMISSIONER SVINICKI: Okay. So based on 5 that, is it fair to characterize that the Staff at 6 this stage has not recommended anything in terms of 7 going forward with the construction permit that it 8 would        identify  as    fundamentally          unlicensable      or 9 unlikely to be able to be operated or licensed at the 10 operating license stage?
11                  MS. GAVRILAS: That's fair.
12                  COMMISSIONER SVINICKI: Okay, thank you.
13 Thank you, Mr. Chairman.
14                  CHAIRMAN BURNS: Thank you, Commissioner.
15 Commissioner Ostendorff.
16                  COMMISSIONER          OSTENDORFF:      Thank      you, 17 Chairman. Thank you all for your briefs today, and for 18 the work of you and your teams. It's important work.
19                  I want to maybe, Mirela, pick up a little 20 bit with where Commissioner Svinicki was probing with 21 you. From your Slide 8 where you said the Staff used 22 existing guidance in the discussions with Commissioner 23 Svinicki and the exchange during her Q & A, I just 24 want to make sure I understand one thing. I think it 25 is that you did not -- you and your team did not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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83 1 experience any challenges working within our existing 2 regulations with our existing guidance as far as being 3 able to I'll say on the fly adapt where judgment would 4 lead one to say this is a reasonable way of handling 5 a particular design issue.
6                  MS. GAVRILAS: No, the challenges as I --
7  in my earlier answer, the challenge is where the bar 8 for construction permit needs to be set relative to 9 what our expectations are in the final design. That 10 was where the Staff needed to exercise its technical 11 judgment. We haven't had areas where we needed to --
12    where we had significant gaps that we needed to 13 address, if I understood your question correctly. If 14 I didn't --
15                  COMMISSIONER OSTENDORFF: Let me rephrase 16 it because I'm not sure -- I may not have asked it as 17 clearly as I should have.
18                  Were there flaws or gaps in the existing 19 NRC regulations or guidance that prevented your team 20 from doing their work on the construction permit?
21                  MS. GAVRILAS: There was one issue that we 22 had      to    address,    specifically          the  fact that      the 23 irradiation facility was not covered under Part 50 24 because they're subcritical and the definition for 25 irradiation facility --
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84 1                  COMMISSIONER OSTENDORFF: I understand. The 2 Commission got involved in that here.
3                  MS. GAVRILAS: Yes, that's the only flaw 4 that we found.
5                  COMMISSIONER OSTENDORFF: Okay. And you 6 felt like the -- working within the existing guidance 7 documents that there was sufficient flexibility for 8 the Staff to be able to exercise reasonable judgment 9 as to how to apply certain sections?
10                  MS. GAVRILAS: Yes. And that might be aided 11 by the fact that the existing guidance that we relied 12 upon was primarily NUREG-1537, which is designed for 13 research reactors which do exhibit a fair amount of --
14                  COMMISSIONER OSTENDORFF: Okay.
15                  MS. GAVRILAS:        -- differences.
16                  COMMISSIONER OSTENDORFF: Okay. I think 17 this is still a question for you, but others may want 18 to chime in here. The first session with the SHINE 19 panel, I asked a question that was addressed I think 20 by      Eric  about  the    use    of    prototypes    by    SHINE 21 organization,        the      reference        to  other  existing 22 reactors, and I think Eric mentioned one from the Los 23 Alamos National Laboratory. Can you talk at a high 24 level about how our Staff perhaps used experience of 25 these prototypes or other existing technologies to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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85 1 consider the construction permit?
2                  MS. GAVRILAS: I'm going to ask Steve Lynch 3 who was the Project Manager on SHINE to talk about 4 specifics.
5                  CHAIRMAN BURNS: Okay. And, Mr. Lynch, 6 identify yourself for the record, and confirm that you 7 took the oath.
8                  MR. LYNCH: Yes. My name is Steve Lynch. I 9 am the Project Manager for SHINE on the NRC Staff. And 10 yes, I did take the oath.
11                  CHAIRMAN BURNS: Okay, proceed.
12                  MR. LYNCH: Yes. As far as facilities most 13 we considered on the irradiation facility side were 14 existing research reactors and past experience with 15 aqueous        homogeneous      reactors.        On  the  production 16 facility side we did look back to our licensing 17 experience with the Cintichem facility. We actually 18 did have on staff former employees from Cintichem that 19 helped inform the development of our guidance and the 20 beginning of our review.
21                  COMMISSIONER        OSTENDORFF:      Can  you    talk 22 about, Steve, I think Eric had mentioned SHINE's own 23 prototype efforts. Can you talk about how you might 24 have looked at those, or considered those in your 25 review?
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86 1                  MR. LYNCH: We have not looked extensively 2 at the prototypes. We have considered some of the 3 papers that have come out from the National Labs 4 describing their results. We will look more carefully 5 at that at the operating license stage.
6                  COMMISSIONER OSTENDORFF: Okay, thank you.
7                  Jane, I don't want you to go without a 8 question here.
9                  MS. MARSHALL: Thank you, sir.
10                  COMMISSIONER        OSTENDORFF:        I'll  ask      an 11 environmental review question. And, you know, I think 12 Mirela has mentioned -- my question is what is this 13 like,        the environmental        review,      is  this  like      a 14 research test reactor, or is it like in Marissa's 15 bailiwick the fuel cycle facility? What is -- does the 16 environmental review look like? Is it a hybrid of 17 these, or something else?
18                  MS. MARSHALL: It's a hybrid. I guess we're 19 lucky in a sense. All of the environmental regulations 20 are in Part 51, so we didn't have to look beyond that.
21 And as part of the environmental review, we looked at 22 the      connected  action      so    we    didn't    just  look      at 23 construction, we looked at operation, decommissioning, 24 traffic flow. So, in that sense it was much like any 25 other environmental impact statement that we would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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87 1 prepare.
2                COMMISSIONER        OSTENDORFF:    Okay. Anybody 3 else on that? All right, thank you. Thank you all.
4                CHAIRMAN BURNS: Thank you, Commissioner.
5 Commissioner Baran.
6                COMMISSIONER BARAN: Thanks. Well, let me 7 start by thanking you and the rest of the Staff who 8 worked on this application for all the hard work that 9 went not only into preparing for today's hearing, but 10 also      all the  efforts      in    reviewing    this    unique 11 application.
12                I wanted to follow-up on a couple of 13 things I asked about -- asked SHINE about on the first 14 panel. Going back to the ACRS letter and the seven 15 topics that they identified that should be further 16 addressed in an application for an operating license.
17 We talked to SHINE about that. They said those are 18 going to be addressed in their Corrective Action 19 Program. Can you talk a little bit about how the Staff 20 intends to insure that those issues are addressed in 21 the operating license application?
22                MS. GAVRILAS: Some of the items that came 23 out of the ACRS discussions are actually captured in 24 our SER. They are among the items that we listed in 25 Appendix A. Perhaps it's not the complete list, but NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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88 1 we'll        make  sure    that      when    operating    review      --
2  operating license review time comes we will look at 3 the entirety of the items that were mentioned by the 4 ACRS in their letter.
5                  There were also commitments that SHINE 6 made      explicitly    to    the    ACRS,      and  those we    also 7 captured in the SER in the same Appendix A on the two 8 items that the ACRS had engaged them on, that the 9 Staff had not previously had discussions with them.
10 So, we fully intend to follow-up on all the items 11 raised by the ACRS.
12                  COMMISSIONER BARAN: Okay. And just to 13 clarify        then  for    the  answers        to  the pre-hearing 14 question related to this, some but not all of these 15 items the ACRS identified were captured as commitments 16 on Appendix A, in Appendix A.
17                  MS. GAVRILAS: I believe that is the case.
18 We'll check during the lunch break and we'll get back 19 to you at the end of the day, if we need to make a 20 correction on that.
21                  COMMISSIONER BARAN: Okay, great. Thanks.
22                  And as we've noted at various points, some 23 of the regulations, like the general design criteria, 24 don't apply to SHINE because it's not a reactor. But 25 the Staff considered these regulations when doing its NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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89 1 review, and the Applicant considered them in its 2 design. Can you describe that process in a little bit 3 more detail? Would the Staff ask RAIs on concept from 4 the general design criteria, or were these used as a 5 reference for the technical reviewers? What role did 6 they play?
7                MS. GAVRILAS: So, there's the expectation 8 in 50.34 of providing principal design criteria as 9 unambiguous, so we want that. What SHINE did in their 10 application, they actually came and had crosswalk 11 tables of all the 55 GDCs, how they apply or not 12 apply, or adapt to the features of their facility. So, 13 the Staff scrutinized that and found it acceptable.
14 And I will give an example for containment, GDC-16 15 deals with containment. They have a confinement, but 16 they adapted the notion of controlled leakage that's 17 intended in GDC-16. So, in addition to the GDCs, they 18 also have the GDCs, as you mentioned, are designed for 19 light water power reactor.
20                They also have a production facility that 21 has      unique  features.      There      they    proposed    safety 22 systems and components that actually lend themselves 23 to additional criteria. I'll give an example, the 24 concentration of uranium in the solution. That will 25 become part of the design basis. That is part of their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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90 1 design basis, and it's a design criteria for them.
2                  COMMISSIONER          BARAN:        Thanks,    that's 3 helpful.
4                  Bill, I have one question I think is 5 probably for you. And that has to do with how we're 6 going to oversee and inspect the SHINE facility during 7 construction if a construction permit is issued. Our 8 current construction inspectors have inspected against 9 the more detailed information provided in an operating 10 license. How would we insure that the inspectors are 11 prepared to inspect against a construction permit?
12                  MR. DEAN: So, I'll start and there may be 13 some      others  who  can    augment,        maybe  some  of    our 14 battalion of witnesses might want to chime in here.
15                  So, we'll be leveraging, obviously, the 16 construction inspection experience that we have in 17 Region II to support the construction activities.
18 Clearly,        we'll  need      to    develop      a  construction 19 inspection program much like we did for the Vogtle and 20 VC Summer units. So, we have a model there, obviously, 21 it's going to be scaled down, but I would expect that 22 what we would have would be a replica of a much 23 smaller        scale  as    to    what    we've      done  with      the 24 construction of the AP-1000s.
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91 1 done        significant    work      in    that      direction.      And, 2 actually, our Office of New Reactors worked with 3 Region II and, of course, with the rest of us, and 4 there is inspection procedures. And the lead on that 5 was Carl Weber, one of our witnesses, and he can talk 6 about the substance of that procedure.
7                  CHAIRMAN BURNS: Okay. Identify yourself, 8 and confirm you've been put under oath.
9                  MR. WEBER: My name is Carl Weber. I work 10 for the Office of New Reactors in the Construction 11 Inspection Branch. And I helped to develop the overall 12 inspection program for basically radioactive isotope 13 production. We didn't do a specific program just for 14 SHINE, we made it fairly generic. And what we did was 15 we went back and looked at similar -- programs with 16 similarities. For example, we looked at the Watts Bar 17 program where they were inspecting to a construction 18 permit. We also looked at the mixed oxide facilities, 19 and      we    looked  at    the    Louisiana      Energy  Services 20 programs. We got a group of people together who had 21 experience in this area, had a working group. We got 22 all their experience, and we developed the program 23 specifically for the radioactive isotope production.
24                  CHAIRMAN BURNS: Okay. And confirm you were 25 put under oath before.
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92 1                  MR. WEBER: Pardon me?
2                  CHAIRMAN BURNS: You did take the oath 3 before?
4                  MR. WEBER: Oh, yes. I'm sorry.
5                  CHAIRMAN BURNS: Okay, thanks.
6                  COMMISSIONER BARAN: Thank you very much.
7                  CHAIRMAN      BURNS:          I    appreciate        the 8 exploration        of    the      differences          in  terms        of 9 construction permit versus operating license that my 10 colleagues have done so far. A couple of questions I 11 had actually, you know, potentially looking forward.
12 In effect, what we actually have is eight production 13 facilities. Correct?
14                  MR. LYNCH:      Well,      there      will  be    eight 15 individual licenses.
16                  CHAIRMAN BURNS: Eight individual. Will 17 there be eight individual licenses --
18                  MS. GAVRILAS: Utilization facility.
19                  CHAIRMAN BURNS:          -- or is this -- would 20 the      intention  to    be  combined        into    one  operating 21 license?
22                  MS. GAVRILAS:        It's      eight    utilization 23 facilities, the irradiation facilities. And we're 24 looking at that. So, for example, just recently we 25 were      scanning  50.56    and    we  saw      one  construction NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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93 1 permit, one operating license, and then we gave some 2 thought to 50.52, that you can have activities from --
3  that you would license by themselves. You could have 4 them      all  under  one    license.        But    that's  all      our 5 thinking, it's preliminary. It will depend on what 6 SHINE applies for, and then we'll need to be more 7 rigorous in our considerations.
8                    CHAIRMAN BURNS: Okay. And a couple of 9 other questions. And, again, because we're adapting 10 this type of facility to the Part 50 framework, but 11 two others -- so, in this term have you looked down 12 the road as well, we're looking at license -- because 13 I heard someone mention licensed operators. So, we 14 think that's something that would be required or of 15 value as part of this facility licensing?
16                    MS. GAVRILAS: SHINE has, I believe, said 17 that they will have operators for the irradiation --
18    for      the  radioisotope        production        part  of    their 19 facility, so that we need to look into more detail 20 what provisions are in 50.55 for licensing operators, 21 if    there's    any  need    for    it.      So,  again,  this      is 22 exploratory.        They're      just      things      that  as    we're 23 reviewing the construction permit application are 24 coming to mind and we're jotting them down that we 25 need      to  explore    them    further        for  the  operating NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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94 1 license.
2                    CHAIRMAN BURNS: Okay. And I'll just put 3 one more on the plate there, because I saw in the -- I 4 was looking at the draft construction permit and it 5 speaks        to  the  financial        protection        and indemnity 6 requirements which are under Price-Anderson Act. And, 7 again, it's a Part 50 facility, so I mean looking at 8 the regulations, confirm under Part 140, Part 50 9 facility has those -- so, again, is that -- now, 10 again,        I  take  it    the  Staff      is      looking at    those 11 requirements under Price-Anderson to the extent that 12 they would apply. Obviously, this is not a large, you 13 know,        1,300  megawatt      or    1,000      megawatt  operating 14 plant, so there are different provisions, but I'm 15 presuming that's also something you need to resolve in 16 the longer term for the operating license.
17                    MS. GAVRILAS: I've noted your comment.
18                    CHAIRMAN BURNS: okay.
19                    MS. GAVRILAS: We haven't so far.
20                    CHAIRMAN      BURNS:      Okay.      Because    it      is 21 mentioned in the draft construction permit which is 22 what highlighted it to me.
23                    MS. GAVRILAS: Okay, then I'm probably 24 unaware of our discussions.
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95 1 also, in terms of one of the findings highlighted, one 2 of the findings was that the Applicant is technically 3 and      financially      qualified        for      purposes    of      the 4 construction permit. Can you give me a description of 5 what      the  Staff    did    with    respect        to  looking        at 6 financial qualifications for the construction permit?
7                    MS. GAVRILAS: At a very high level, we 8 basically scrutinized the funds that they have from 9 private investors. We also know that they are funded 10 by the Department of Energy, and we found that to be 11 sufficient for the purpose of construction permit.
12                    CHAIRMAN BURNS: Okay, thanks.
13                    There is a distinction, I think, made on 14 one of the slides between conditions in -- I think 15 it's on Slide 9. The slide says, "In some cases permit 16 conditions are necessary. In other circumstances" --
17  then the next bullet says, "Regulatory commitments 18 track        items  for    resolution        in    the    Final    Safety 19 Analysis Report or FSAR."
20                    Can the Staff give me a distinction, what 21 elevates itself to a condition versus a commitment 22 that somehow is tracked and how do you track those 23 commitments?
24                    MS. BAILEY:        The      conditions      in      the 25 construction permit are really associated with the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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96 1 criticality, radiological safety primarily for the 2 radioisotope production facility. Criticality safety, 3 that part of the facility is controlled primarily 4 through geometry and the configuration of design. As 5 SHINE mentioned earlier, the design is preliminary.
6 It's still under development, as well as the analysis 7 that goes with it. So, the permit conditions basically 8 allow the Staff to confirm as the design and the 9 evaluations of the design progress that it's being 10 done in accordance with the design criteria that's 11 described in the Preliminary Safety Analysis Report.
12                    What the conditions really do is it gives 13 us the assurance that SHINE will be able to provide 14 the necessary design and technical information in the 15 Final Safety Analysis Report for us to complete our 16 safety        evaluation.      So    part      of  that goes        to 17 Commissioner Svinicki's question about mitigating or 18 avoiding a rework of the facility once construction is 19 well underway or completed.
20                    CHAIRMAN BURNS: Okay. My final question 21 relates to the -- stated by the Staff, the Staff used 22 NUREG-1537 which has guidelines for preparation and 23 review of applications related to non-power reactors.
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97 1 prepared for evolving technologies that were not fully 2 developed and demonstrated at the time of publication.
3 What has been your experience with using this Interim 4 Staff Guidance? What do you think you've learned from 5 using it? Is it doing what you hoped it would do?
6                  MS. GAVRILAS: It is doing what we hoped it 7 would do. It met our purposes just fine for the 8 construction permit, and we anticipate that it will 9 continue to do so for the operating license. We found 10 one      fundamental  problem        with    the  guidance  as      we 11 developed it, and that had to do, we thought that the 12 irradiation facility was going to be able to be 13 reviewed as part of the production facility. That was 14 not the case for SHINE, for example. But other than 15 that,        the Interim    Staff      Guidance      works,  and      we 16 anticipated incorporating it into NUREG-1537 at the 17 next revision of the document.
18                  CHAIRMAN BURNS: Okay. And the reason I 19 want to make sure I understand; the two parts of the 20 facility could not be -- I'm trying -- you said they 21 could not be reviewed?
22                  MS. GAVRILAS: Yes, we initially --
23                  CHAIRMAN BURNS: Explain that.
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98 1 that      the  irradiation      facility        and  the  production 2 facility can be treated as one entity. And then when 3 we saw the SHINE application and we started giving 4 more      thought,    we  realized        that      they're  actually 5 distinct and they deserve to be -- they need to be 6 examined separately.
7                  CHAIRMAN BURNS: But examined separately in 8 what        sense,  that      the    regulatory        footprint        is 9 different? Again, I think of a large power reactor 10 that has a number -- it has a reactor, it has a number 11 of other buildings that may support it. So, help me 12 along here.
13                  MR. DEAN: Can I -- let me just --
14                  MS. GAVRILAS: Yes.
15                  MR. DEAN: At a high level, I think if you 16 looked at the irradiation facility, that's more like 17 a research and test reactor. Right? Whereas, the 18 radioisotope production facility really has a lot more 19 commonality with a fuel cycle facility.
20                  CHAIRMAN BURNS: Okay.
21                  MR. DEAN: Chemical processes, so I think 22 that      kind  of  was    --  as    we    looked    at  the    SHINE 23 application, we realized we probably need to treat 24 them sort of independently because of that. I don't 25 know if, Marissa, you have anything you want to add in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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99 1 that regard?
2                    MS. BAILEY: I think that's pretty close.
3 I    think    it's  really      in    terms      of  what  are      the 4 applicable acceptance criteria for each type of the 5 facility.        So,  for    example,      for      the  radioisotope 6 production facility because it resembles a fuel cycle 7 facility        in  terms    of  processes          and  hazards,        we 8 determined that even though it's licensed under Part 9 50, we could use the performance objectives in Part 70 10 to make a determination of acceptability for safety.
11                    CHAIRMAN BURNS: Okay. But, ultimately, 12 this is all licensed ---
13                    MS. BAILEY: Under Part 50.
14                    CHAIRMAN BURNS: Under Part 50, and it's 15 all licensed -- there's not another licensing action 16 going        on. I  understand        that      the    criteria      are 17 different. We've sort of banged this into Part 50 for 18 the subcritical assemblies in those units, and you 19 have this other part which is more like something we 20 -- that NMSS would typically license. But the whole 21 thing is put together, ultimately, under this license.
22                    MS. GAVRILAS: That's right.
23                    MS. BAILEY: Yes.
24                    CHAIRMAN BURNS: Okay. All right, thank 25 you. Commissioner Svinicki.
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100 1                COMMISSIONER SVINICKI: Just a follow-up.
2 In response to the Chairman's question on Price-3 Anderson indemnification and the Staff's answer, that 4 engendered a very energetic sidebar between counsel 5 for the Staff. Catherine or Mitzi, was there anything 6 counsel for the Staff wanted to respond on that, or is 7 that just you were excited because when the Chairman 8 opens the CFR during the meeting, you know something 9 is going to happen. Right? Did you want to provide any 10 augmentation to the Staff's answer on that? You could 11 say no, it's fine. You don't have to. I'm not saying 12 explain yourselves. I'm just saying, did you want to 13 supplement their answer?
14                MS. YOUNG: Mitzi Young, counsel for the 15 NRC Staff. First of all, let me defend myself. We've 16 been animated through the whole hearing. Every time 17 you ask a question we're excited because in your 18 questions you ask the questions we practice with them 19 in part, so this has been exciting from a number of 20 respects. But in terms of Price-Anderson, that is part 21 of the review. I believe 140 talks about a certain 22 power level for reactors, and I think what SHINE did 23 in their application, and Steven Lynch is obviously 24 more conversant on this than myself. They looked at 25 comparable power thermal output to identify what level NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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101 1 of Price-Anderson protection they would need to the 2 extent that they're not receiving Special Nuclear 3 Material to get a construction permit. That assurance 4 is not needed now, but it would be part of the 5 operating license review.
6                Steve, was there anything you wanted to 7 add?
8                MR. LYNCH: That's it.
9                MS. YOUNG: Thank you.
10                CHAIRMAN BURNS: All right, thanks very 11 much, Mitzi.
12                MS. YOUNG: Thank you.
13                CHAIRMAN BURNS: Thanks, Commissioner.
14                With that, we'll take a brief break and 15 then resume with Safety Panel 1. So, try to be back in 16 your seats in about five or six minutes.
17                (Whereupon, the proceedings went off the 18 record at 11:05 a.m., and went back on the record at 19 11:15 a.m.)
20                CHAIRMAN BURNS:          We'll call the hearing 21 back to order. In this next session we'll have Safety 22 Panel 1 and we'll hear first from the Applicant, 23 SHINE. We'll immediately follow that with the staff's 24 presentation for Safety Panel 1 and then follow with 25 Commissioner questions.            And in general the topics NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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102 1 will cover the chapter 1 of the Safety Evaluation 2 Report with respect to the facility, and chapter 4, 3 irradiation unit and radioisotope production facility 4 description to address the licensing considerations 5 for      the    subcritical      utilization          facilities      and 6 production facility.
7                    So with that, we'll go to our first panel 8 from SHINE.          Mr. Hennesy and Mr. Van Abel are here, 9 but, Ms. Kolb, I'll ask you to introduce yourself.
10                    MS. KOLB: My name is Catherine Kolb. I'm 11 a    supervisor        in    engineering          for    SHINE  Medical 12 Technologies.
13                    CHAIRMAN BURNS:        Okay.      Thanks very much.
14 And again, assume that the Commission is generally 15 familiar with the prehearing filings, and I remind you 16 you're under oath.            And please proceed.
17                    MR. VAN ABEL:          All right.        Good morning 18 again.        In this presentation I'd like to give a brief 19 continuing discussion on the facility.
20                    If we'd go to the next slide, slide 2.
21 Here again is the overall facility process overview.
22 We went through this in some detail in the overview 23 discussion.          I'm going to add a little additional 24 detail on the design requirements for these SSCs in 25 this presentation, but of course if we have any other NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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103 1 questions on the overall facility design, happy to 2 answer those as well.
3                    Next    slide,      please.          For  the    SHINE 4 facility certain SSCs are designated as safety-related 5 in our facility because they are relied upon to 6 perform        safety    functions        either        during    normal 7 operations or during design-basis events.                      And those 8 SSCs that are required to perform safety functions are 9 required        to  perform      those      in      the    environmental 10 conditions of normal operation and any accidents in 11 which they are required to function.                      For those SSCs 12 that      have  safety      significance,            we  design    them, 13 fabricate them and test them commensurate with the 14 criteria set forth in ANSI/ANS-15.8, which are the 15 quality assurance requirements for research reactors.
16 SHINE implements that ANSI/ANS-15.8 standard through 17 our Quality Assurance Program description, or QAPD.
18                    Next slide, please. On this slide we have 19 the safety-related definition that SHINE applies to 20 design. This is a comprehensive definition that we've 21 modified from 10 CFR 50.2 and we've also included the 22 requirements        from    10  CFR    70.61,      the  performance 23 requirements        there    as    they're        applicable      to    the 24 radioisotope production facility.
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104 1 that are relied upon to meet any of the six criteria 2 listed here.        The first three are modifications of 10 3 CFR 50.2 and include the integrity of the primary 4 system boundary, the capability to shut down our 5 target solution vessel in a radiation process and 6 maintain at shutdown, and the capability to prevent 7 accident dose consequences that would exceed 10 CFR 8 20.
9                  And the last three are familiar to the 10 fuel cycle facility folks.              These are to ensure that 11 our nuclear processes remain subcritical including the 12 use of an approved margin of subcriticality, to ensure 13 that chemical exposures from accidents are acceptable 14 for both the worker and the public, and that an intake 15 of 30 milligrams or greater of soluble uranium does 16 not occur for personnel outside the owner-controlled 17 area, the OCA.
18                  Next slide, please.                For our SSCs we 19 require them to be designed to withstand external 20 events.        Our outer building structure is designed to 21 resist external events such as tornadoes, aircraft 22 impacts and other external events.                    And also the SSCs 23 within the building are required to withstand our 24 design-basis          earthquake          if      they    perform        a 25 safety-related function or they're necessary to ensure NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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105 1 they        do    not    degrade        the      performance    of      a 2 safety-related SSC.
3                    We also apply a graded quality level to 4 the design of our SSCs.              We have three quality levels 5 as described here.            Quality Level 1 is applied to our 6 safety-related components SSCs, and that is the full 7 measure of our QAPD is applied to those SSCs.                        Also, 8 we apply Quality Level 2 to SSCs that could affect the 9 safety function of safety-related SSCs specifically to 10 support or protect the safety function of those SSCs.
11 And we apply graded quality to those components that's 12 commensurate what their importance to safety.                            And 13 Quality Level 3 is applied to those SSCs that don't 14 meet the definition of Quality Level 1 or 2.
15                    Next slide, please.            We also apply single 16 family criterion to our systems.                      For safety systems 17 we ensure that there is sufficient redundancy and 18 independence such that a single failure of an active 19 component does not result in the loss of capability to 20 perform        the  safety      function.          And  for  accident 21 analysis        we    ensure      that      a    single    failure        in 22 conjunction with the initiating event does not result 23 in the loss of the safety system's ability to perform 24 the safety function. So throughout our design process 25 we use a robust defense-in-depth approach to design, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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106 1 and we have a strong preference in the design for 2 passive and engineered controls over administrative 3 controls.      And that concludes my presentation.
4                  CHAIRMAN BURNS:          Okay.      Thank you.      And 5 I'll ask the staff witnesses to come forward, take 6 their seats at the table.
7                  And I remind you that you're under oath 8 and start with the introduction of the witnesses.
9 Start with you, Mr. Lynch.
10                  MR. LYNCH:      My name is Steve Lynch.              I'm 11 the project manager for SHINE Medical Technologies on 12 the NRC staff.
13                  MR. ADAMS:      My name is Al Adams.          I'm the 14 Chief of Research and Test Reactor Licensing in NRR.
15                  MS. ADAMS:      Mary Adams.        I'm an engineer 16 in the Division of Fuel Cycle Safety Safeguards and 17 Environmental Review in NMSS.
18                  CHAIRMAN BURNS: Okay. Thank you. Please 19 proceed.
20                  MR. ADAMS: Good morning. This panel will 21 discuss        will    discuss          the        unique  licensing 22 considerations of the SHINE utilization and production 23 facilities.        I will discuss the general licensing 24 considerations and a review performed by the Advisory 25 Committee on Reactor Safeguards, the ACRS.                        Steve NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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107 1 Lynch will discuss the licensing of the irradiation 2 units and Mary Adams will discuss the licensing of the 3 production facility.
4                  Next    slide,      please.          SHINE  seeks        to 5 construct      non-power      utilization          facilities    and      a 6 production        facility.            Therefore,        an    initial 7 consideration was whether to license SHINE's proposed 8 facilities under Section 103 or Section 104 of the 9 Atomic Energy Act.        While the hazards associated with 10 SHINE's facility are similar to non-power research 11 reactors which are licensed under Section 104 of the 12 Atomic Energy Act, SHINE's facility is intended to be 13 used      for commercial      purposes,        not  for  conducting 14 research      and    development          or      medical  therapy.
15 Therefore,      while    the    licensing        process  would        be 16 similar to a research reactor, SHINE's facility would 17 be licensed under Section 103 of the Atomic Energy 18 Act.
19                  Section 103 imposes additional procedures 20 on    construction    permit      applications        including        an 21 independent review of the application by the ACRS and 22 a    mandatory    hearing,      which    we    are  having    today.
23 Because SHINE's facility is a subcritical system which 24 produces fission power, it introduces aspects of a 25 review typically done for non-power reactors.                          For NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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108 1 these areas the staff developed and used the Interim 2 Staff Guidance for NUREG-1537, which is a standard 3 review plan for non-power reactors.
4                    Next slide, please.            The staff presented 5 the      results    of  its    safety      review    at  three      ACRS 6 Subcommittee        meetings      and    before      the  full    ACRS.
7 During its review the ACRS identified two safety 8 concerns that could impact the operation of the SHINE 9 facility        if  not    sufficiently          addressed.        These 10 concerns were the capability to lay up the facility 11 and the facility's ability to withstand potential 12 aircraft impact.
13                    SHINE and the staff provided additional 14 information to the ACRS in these areas.                        The ACRS 15 determined that sufficient information was provided 16 such      that  it    could    recommend        the  issuance      of    a 17 construction permit. This recommendation is reflected 18 in the ACRS letter dated October 15th, 2015, which is 19 in the staff's SER.
20                    The  ACRS    letter      also    noticed  several 21 issues that must be addressed at the operating license 22 stage including criticality control and margin.                          The 23 staff agrees that each item that the ACRS identified 24 must be addressed at the operating license stage. And 25 Mirela was correct during her testimony that written NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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109 1 comments were not provided, or written commitments 2 were      not provided      by  SHINE      in    all  these    areas, 3 however, the staff is aware of them and we determined 4 that they're not needed for the issuance of the 5 construction permit, but will be addressed at the 6 operating license stage.
7                  Next slide, please.            Steve Lynch will now 8 discuss specific licensing considerations related to 9 the SHINE irradiation facility.
10                  MR. LYNCH:      Thanks, Al.          SHINE's proposed 11 irradiation        units      presented          unique    licensing 12 considerations        under    10    CFR    Part    50,  which      has 13 traditionally been applied to the construction and 14 operation      of  nuclear      reactors.            However,    unlike 15 nuclear reactors, SHINE's irradiation units are not 16 designed to go critical during operation.                  Therefore, 17 SHINE's irradiation units represent a new application 18 of technology.
19                  Given their subcritical nature the staff 20 considered        whether      it      should        review    SHINE's 21 irradiation units under 10 CFR Part 70 which can be 22 applied to certain facilities that possess and use 23 special nuclear material.            However, these facilities, 24 generally referred to as fuel cycle facilities, have 25 the common objective of avoiding criticality by a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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110 1 significant margin under both normal operating and 2 accident conditions.            In contrast, SHINE's minimal 3 margin of subcriticality is less than what has been 4 previously approved for other 10 CFR Part 70 licensees 5 and more closely resembles the operating state of a 6 nuclear reactor.
7                  Because of this the staff determined that 8 it would be most appropriate to use the 10 CFR Part 50 9 regulations for utilization facilities to perform its 10 technical review of the irradiation units. Therefore, 11 the NRC issued a direct final rule that revised the 12 definition of utilization facility in 10 CFR 50.2 to 13 add SHINE's subcritical operating assemblies.                            If 14 licensed, SHINE's irradiation units would be the first 15 utilization        facilities      to    operate      in  a minimally 16 subcritical range.
17                  Next slide, please.            Classifying SHINE's 18 irradiation units as utilization facilities allowed 19 the      staff  to  conduct      its    review      following      the 20 regulations designed for technologies with similar 21 radiological, health and safety considerations.                          In 22 particular, the accelerator and neutron multiplier of 23 each irradiation unit achieve a fission rate with a 24 thermal        power  level    comparable          to  that of    other 25 non-power reactors licensed under 10 CFR Part 50.
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111 1 Because of the thermal power levels the irradiation 2 units share similar safety considerations with other 3 non-power      reactors      including        provisions  for      the 4 removal of fission heat during operation, passive 5 decay heat generation after shutdown, fission gas 6 release and accident scenarios.
7                Given these safety considerations and the 8 functional similarities of the irradiation units to 9 non-power reactors, the staff relied on the guidance 10 provided in NUREG-1537 as supplemented by Interim 11 Staff Guidance for aqueous homogeneous reactors to 12 conduct its review.            Specific design areas of the 13 staff's review included SHINE's reactivity control 14 mechanisms, light water pool and biological shielding.
15                Next slide, please.            Mary Adams will now 16 discuss licensing considerations related to the SHINE 17 radioisotope production facility.
18                MS. ADAMS:        Thanks,        Steve. SHINE's 19 radioisotope production facility is distinct from the 20 irradiation facility. The RPF contains hot cells that 21 will process irradiated materials containing SNM in 22 batches of greater than 100 grams. Therefore, the RPF 23 is a production facility as defined in 10 CFR 50.2.
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112 1 performed at fuel cycle facilities.                    These processes 2 include the UREX and liquid waste evaporation and 3 solidification        processes.          With      the  exception      of 4 target solution preparation with fresh LEU, all of the 5 processes will be performed on irradiated special 6 nuclear material.              Therefore, the staff used the 7 guidance in NUREG-1537 as supplemented by Interim 8 Staff Guidance to guide its review of the radioisotope 9 production facility.
10                  The acceptance criteria in the Interim 11 Staff Guidance are drawn from NUREG-1520, the standard 12 review plan for fuel cycle facilities.                          The ISG 13 contains        baseline      design      criteria        and  accident 14 analysis guidance which include the criteria in 10 CFR 15 70.64.        As noted in the guidance, an application 16 meeting these baseline design criteria would b found 17 acceptable by the staff.              SHINE's construction permit 18 application proposed these acceptable baseline design 19 criteria for the RPF. After reviewing the application 20 the staff finds that SHINE's application met these 21 baseline design criteria.
22                  Next slide, please.            In doing its review 23 the      staff  identified      certain        items    that  must      be 24 addressed prior to the completion of construction, 25 therefore, the staff is recommending certain permit NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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113 1 conditions.        In particular, the staff has proposed 2 four criticality safety permit conditions which are 3 confirmatory and require SHINE to submit periodic 4 reports to the NRC.
5                  These reports must address the technical 6 basis of the criticality accident alarm system, the 7 basis for determining that criticality events are not 8 credible for the RPF processes, criticality safety 9 analyses for processes using fissile material and the 10 reactivity contributions from all fissile isotopes.
11 The staff is also recommending a permit condition 12 related to radiation protection to ensure shielding 13 and occupancy times within the RPF are consistent with 14 as low as is reasonable achievable practices and dose 15 requirements of 10 CFR Part 20.
16                  This concludes the staff's remarks for 17 Safety Panel 1.        We will respond to any questions you 18 may have at this time.
19                  CHAIRMAN BURNS:          Okay. Thank you very 20 much.        And what I would ask the staff -- now, Mary, 21 you're probably okay, but Mr. Lynch and Mr. Adams, if 22 you could maybe slide over this way, then we have a 23 good -- we can see all the witnesses at once as we 24 begin our questions.            And we'll begin our questions 25 for this panel with Commissioner Ostendorff.
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114 1                  COMMISSIONER        OSTENDORFF:        Thank      you, 2 Chairman, and thank you all for your briefs.                          I do 3 have a question for the Applicant, and I'm going to 4 your slide 6.        And under the single failure criterion 5 being applied to safety systems, I just wanted to ask 6 a high-level design philosophy question, if I could.
7                  Can you talk a little bit about how your 8 single failure does not result in a loss to the 9 ability to perform its function?                    Can you talk about 10 how      you  apply  that      concept        to  reliability        of 11 electrical power as it affects instrumentation control 12 or alarms?
13                  MR. VAN ABEL:          Yes, for instrumentation 14 control and electrical power we have very minimal 15 requirements for those for safety-related purposes.
16 And those that we do have are primarily for hydrogen 17 mitigation after shutdown and some instrumentation 18 control        systems    that      monitor        the  system    after 19 shutdown.            And      those      are      provided    by      an 20 uninterruptible        power      supply      system    that will        be 21 designed based on single failure criterion to look at 22 failure of components such as a breaker supplying 23 power to ensure that there's redundant reliable means 24 to supply that power to the equipment requiring it.
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115 1 your        criticality    alarm      system,        does  that      have 2 redundant power supplies?              Or that may not have been 3 designed yet; I don't know, but where does that fall 4 with respect to this philosophy of redundancy?
5                  MR. VAN ABEL:          It would be.        It's not 6 designed yet, but it's a safety-related system, so --
7                  COMMISSIONER OSTENDORFF:              Okay.
8                  MR. VAN    ABEL:        --    these  same    design 9 principles would apply.
10                  COMMISSIONER OSTENDORFF:                Okay.      Thank 11 you.
12                  Let me shift back to the staff now. Mary, 13 I wanted to ask you a question on your slide, I think 14 7 -- excuse me, 8. There's a reference to criticality 15 events not being credible.                  Can I just ask you to 16 elaborate on that just a little bit about what's the 17 basis for that statement?
18                  MS. ADAMS: 10 CFR 70.61, which formed the 19 basis of the Interim Staff Guidance, states as an 20 acceptance criterion that all processes need to be 21 subcritical        under      normal      and      credible  abnormal 22 operating conditions.              And so, what exactly does 23 "credible abnormal" mean?              And we ask our applicants 24 to very carefully define what they mean by credible 25 and not credible with respect to criticality safety.
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116 1                COMMISSIONER OSTENDORFF: So with respect 2 to the design aspects of what's been presented to the 3 NRC staff how is that achieved?
4                MS. ADAMS:      I want to call on --
5                COMMISSIONER        OSTENDORFF:          Or    as      a 6 condition of not having a credible criticality event.
7                MS. ADAMS:      I'd like to call on Dr. Chris 8 Tripp to answer that question.
9                CHAIRMAN      BURNS:          Okay. And    please 10 identify yourself for the record and confirm that you 11 took the oath earlier.
12                DR. TRIPP:      Okay.      I'm Christopher Tripp.
13 I'm the criticality safety reviewer in FCSS for the 14 RPF, and, yes, I did take the oath.
15                CHAIRMAN BURNS:          Okay.      Please proceed.
16                DR. TRIPP:          Okay.        With  regard        to 17 credibility, when SHINE originally provided their PSAR 18 section on criticality safety, they said that they 19 were going to design it so the criticality would be 20 not credible and then any controls so identified would 21 be identified as SSCs.            This was meant to meet the 22 performance requirements.
23                Some of those criteria that were mentioned 24 were from the performance requirements of Part 70.
25 And the usual approach of the Part 70 side has been NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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117 1 that          we    required          criticality          and      other 2 high-consequence events to be highly unlikely and then 3 those items that we identified as items relied on for 4 safety under the Part 70 framework.                      So there seemed 5 to be some confusion as to what the exact -- how that 6 would be applied to the RPF.
7                    And in the fuel cycle area we have had a 8 lot of discussions in the existing fuel facilities 9 concerning the basis for deciding events are credible 10 or not credible, and when you have to make that 11 demonstration and what you're allowed to take credit 12 for.        So this has been an ongoing issue with the 13 industry.          Therefore, we proposed these conditions to 14 give us additional confidence that they understood 15 what they were committing to be able to apply that 16 acceptably in the design.
17                    COMMISSIONER OSTENDORFF: Okay. Well, are 18 you expecting this condition to lead to articulation 19 of specific engineered features as far as volume 20 control on solution or can you be a little more 21 specific        as  to  how    this    might        play  out  in    the 22 facility's actual design?
23                    DR. TRIPP:        Yes.      So the first step in 24 applying          the  criteria      --    the      main    criteria      for 25 criticality is they be subcritical under normal and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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118 1 credible abnormal conditions.                  So the first step of 2 that is identifying what are the credible criticality 3 hazards        and  then    designing        the      different    safety 4 barriers against that.            So it's at that first step of 5 deciding what is credible and what hazards have to be 6 protected against that we would want to make sure that 7 they had an acceptable way of doing that.
8                    COMMISSIONER OSTENDORFF: So what are some 9 examples?          I'm trying to get to a more practical 10 engineered feature discussion here.                      What are some 11 examples        of  how  the    licensee        might  satisfy      that 12 condition?
13                    DR. TRIPP: Well, there are three criteria 14 for what they consider credible:                    One is an external 15 event with frequency of 10 to the minus 6th based on 16 the fuel cycle guidance that was incorporated into the 17 ISG.      The other is basically a string of independent 18 events that together collectively make up a set of 19 unlikely events that would have to occur that we 20 wouldn't think are credible.                  And the third is that 21 they'd be physically impossible.
22                    COMMISSIONER OSTENDORFF:              So is there an 23 example of the physically impossible that you can 24 offer for us?
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119 1 examples that apply directly to SHINE because we 2 haven't reviewed specific design features at this 3 point.        We've only reviewed the design criteria.                    And 4 the other fuel cycle arrangement -- for example, most 5 of the processing, the solution processing, which is 6 similar to what they have in other parts of the fuel 7 facility,        are  in    safe      geometry        containers,      safe 8 geometry columns and so forth.                  And one of the things 9 you have to guard against is backflow.                        So a lot of 10 the time they're protected against with say a siphon 11 break or an overflow or something of that nature so 12 that -- liquid doesn't flow against gravity.                            That 13 would be considered incredible.                    But it's only based 14 on having that passive feature in the design.
15                    COMMISSIONER OSTENDORFF:                Okay.      That 16 example was very helpful.                  Thank you.        Thank you, 17 Chairman.
18                    CHAIRMAN BURNS: Thanks you. Commissioner 19 Baran?
20                    COMMISSIONER BARAN:              Thanks. I want to 21 ask      about    slide    4    of  SHINE's        presentation      which 22 relates to the definition of structures, systems and 23 components.          The proposed definition, SSC definition 24 states in bullet 3 that SSCs assure the capability to 25 prevent or mitigate the consequences of accidents NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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120 1 which could result in potential exposures comparable 2 to Part 20.        The definition also states in bullet 6 3 that SSCs assure that an intake of 30 milligrams or 4 greater of uranium in soluble form by any individual 5 located outside the owner control area does not occur.
6                  The NRC's occupational dose requirements 7 in Part 20 state that the licensee shall limit the 8 soluble        uranium    intake      by  an      individual    to      10 9 milligrams in a week in consideration of chemical 10 toxicity. Can SHINE discuss the basis for setting the 11 SSC definition at no more than 30 milligrams?                          How 12 does that line up with -- how is that reconciled with 13 the Part 20 requirements?
14                  MR. HENNESY: The definition in Part 6, or 15 the term in Part 6 was derived from the 10 CFR 70.61 16 performance requirements, and that's what it reflects 17 back as.
18                  As far as the 10 CFR 20 requirements, our 19 concern, they would still be applicable and we would 20 still apply that under No. 3.                So we'll have to look 21 at your --
22                  COMMISSIONER BARAN:            Okay.
23                  MR. HENNESY:        -- comment and think about 24 that.
25                  COMMISSIONER        BARAN:          Do you  know      if NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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121 1 there's a time frame that applies to the 30-milligram 2 level?
3                  MR. HENNESY:        I'm not aware of one.
4                  COMMISSIONER BARAN:            Okay.
5                  MR. HENNESY:        Eric, do you have any idea?
6                  MR. VAN    ABEL:        It's      for  an  accident 7 evaluation for --
8                  COMMISSIONER BARAN:            Okay.
9                  MR. VAN ABEL:        -- normal operations.
10                  COMMISSIONER BARAN:            So that's basically 11 total intake --
12                  MR. VAN ABEL:        Yes.      Right.
13                  COMMISSIONER BARAN:                -- over whatever 14 period of time?
15                  MR. VAN ABEL:        That's correct.
16                  COMMISSIONER BARAN:            Okay. And then the 17 Part 20 standards have a limit of 10 milligrams per 18 week.        Maybe I'll ask the staff to comment on this.
19 How did you all conclude that the proposed definition 20 element of an intake of 30 milligrams of uranium in 21 soluble        form  is    an    acceptable          limit  for      the 22 definition?
23                  MS. ADAMS:          I'd like to call on Greg 24 Chapman, the health physicist who reviewed the RPF.
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122 1 physicist.        I did take the oath.
2                  COMMISSIONER BARAN:            Great.
3                  MR. CHAPMAN:          With regards to the 10 4 milligram or 30-milligrams, 30 milligrams is typically 5 the criteria that replaced with the public for Part 6 70-type review.          And we typically look at it as an 7 acute exposure over 24 hours.                  So 10 milligrams for 8 accident exposure as well as 30 milligrams, I would 9 apply the same criteria, 24 hours.
10                  COMMISSIONER BARAN:            Okay. And so under 11 this definition the potential intake from a member of 12 the public of 30 milligrams looks to be about 3 times 13 higher than the limit you would have over the course 14 of a week for someone working at the facility, is that 15 right?
16                  MR. CHAPMAN:        That's correct.
17                  COMMISSIONER BARAN:              Okay. And can you 18 tell us a little bit more about how when you evaluated 19 that that that seemed like an acceptable result?
20                  MR. CHAPMAN:        I'd have to get back with 21 you on that.        I can't recall at the moment.
22                  COMMISSIONER BARAN:            I don't know if this 23 is      a    matter  of    temporal      issue      here  or  there's 24 something else at play, but maybe you could get back 25 to us on that.
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123 1                    Al or Steve, in prehearing question 15 we 2 asked        whether  the    application          specified how      many 3 irradiation units a single operator could control, and 4 both the staff and SHINE stated that that would be 5 addressed during the operating license application.
6 Can you talk a little bit about how the number of 7 operators relates to the size of the control room and 8 whether that's an issue that needs to be resolved now 9 at the construction permit stage?
10                    MR. LYNCH:      So that is something that we 11 haven't looked extensively at the construction permit 12 stage.        Some of the considerations:              More than just 13 the size of the control room, we're looking at the 14 layout of the control room, especially if there will 15 be operators looking at the production facility versus 16 the irradiation facility, and we need to get a better 17 understanding of how the controls will be laid out and 18 to make a determination on the number of operators 19 that are needed.
20                    COMMISSIONER BARAN: Okay. So in terms of 21 getting at the issue that Commissioner Svinicki raised 22 about not wanting a situation where someone has a 23 construction permit, they build something out, we look 24 at it later and say, no, no, that's not going to work 25 and people have to kind of redo things, from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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124 1 staff's point of view is the number of operators, 2 total number of operators that would be working in the 3 control room -- is that going to be relevant to the 4 layout, the construction of that control room in a way 5 that makes it something that we should address now at 6 the construction permit stage, or, no, it's just an 7 operating license issue?
8                MR. LYNCH:      So based on the information 9 SHINE has provided in their PSAR and discussions we 10 had with the ACRS on this issue, the staff hasn't 11 noted anything that would prevent the facility from 12 being able to operate.
13                COMMISSIONER BARAN: Okay. I want to also 14 ask about, follow up on prehearing question 11 related 15 to the probabilities used for aircraft accidents and 16 external design-basis accidents.                  I'm interested in 17 how the staff selected the size of the aircrafts for 18 this hazard analysis.        Did the staff look only at the 19 types of aircraft that could land or take off from the 20 nearest airport that the facility intends to be using 21 quite a bit, or did you also assess larger aircraft 22 that could potentially pass through the air space near 23 the proposed facility?
24                MR. LYNCH:        I think the best person to 25 respond to this question would be Steve Marschke.
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125 1                  CHAIRMAN BURNS: Again, Mr. Marschke, just 2 state your name for the record and your position and 3 confirm that you were put under oath.
4                  MR. MARSCHKE:        My name is Steve Marschke.
5 I work with Sanford Cohen & Associates, and we're 6 consulting staff on the chapter 2 review.                  And, yes, 7 I did take the oath.
8                  When we looked at the aircraft accident 9 probability analysis, we looked at really what SHINE 10 has done.      And they looked at all the accidents which 11 are -- or all the aircraft which land and take off at 12 that airport, the Southern Wisconsin Regional Airport.
13 And they have the statistics from the FAA which 14 identifies the types of aircraft, military aircraft.
15 And      most  of  them    are    air    carriers    and  commuter 16 aircraft and those types of aircraft.                    They've been 17 grouped into those categories.                  They also looked at 18 air corridors, which traverse the area.                    And so, we 19 kind of just -- we reviewed what the SHINE facility 20 has done.
21                  COMMISSIONER BARAN: In terms of those air 22 corridors -- so this is a relatively small regional 23 airport.      I assume the planes as you described are 24 relatively small that will be taking off and landing 25 from there. Are the air corridors that SHINE examined NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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126 1 and that you all looked at -- are those corridors that 2 involve much large aircraft?                    When we talk about 3 planes going to like O'Hare Airport in Chicago or --
4                  MR. MARSCHKE:        The air corridor is -- the 5 probabilities associated with the traffic in the air 6 corridors were very low.              And so, the air corridors 7 themselves fell below the probability cutoffs.                          And 8 it's really the aircraft which are utilizing the 9 regional      airport    which      challenge      the  probability 10 cutoffs.
11                  COMMISSIONER BARAN:            Okay. So any larger 12 aircraft beyond what would land or take off at the 13 regional airport didn't kind of pass the probabilities 14 level to be examined.          Is that correct?
15                  MR. MARSCHKE:        That's correct.
16                  COMMISSIONER BARAN:              Okay. Thank you.
17 And just one more question.                Prehearing question 35 18 focused on the assessment of accidental explosions at 19 the SHINE facility.          SHINE's response to the question 20 stated that they analyzed the potential impact of 21 natural gas pipelines on the facility.                  Can the staff 22 or SHINE, whoever makes sense; maybe the staff, Al or 23 Steve -- can you clarify which natural gas pipelines 24 are in the area of the proposed facility and how the 25 staff determined that they were not hazards?
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127 1                MR. LYNCH:      I think we're going to ask to 2 get some help here as well.
3                COMMISSIONER BARAN:            You're back.
4                MR. MARSCHKE:        I'm back.
5                (Laughter) 6                MR. MARSCHKE:        Can't get enough.
7                COMMISSIONER BARAN:            Still under oath.
8                MR. MARSCHKE:        Yes.      Well, my answer is 9 going to be I'm going to have to get back to you on 10 that, because in preparing for today's meeting I 11 wasn't really looking at the pipelines.                  I wasn't 12 anticipating    --  I    was    anticipating      the aircraft 13 questions, but not the pipeline questions, and so I 14 haven't briefed myself.          Maybe after lunch I can look 15 at my notes and get back in touch.
16                COMMISSIONER BARAN:              Is this something 17 that the staff has looked at?
18                MR. MARSCHKE:        No, we have looked at it, 19 but I just haven't looked at it recently and I don't 20 want to misinform the Commissioners.
21                COMMISSIONER BARAN:            Okay.
22                CHAIRMAN BURNS:          What we can do, we can 23 either hold to the end of the day if the staff wishes 24 to provide a supplemental answer, or we'll proceed 25 with putting it for perhaps a question following up.
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128 1                COMMISSIONER BARAN:              That makes sense.
2 Thank you, Mr. Chairman.
3                CHAIRMAN BURNS:          Thanks, Commissioner.
4                COMMISSIONER        BARAN:          That's  all      my 5 questions. Thank you.
6                CHAIRMAN BURNS:        A couple things:        Just I 7 guess to -- given some of my colleagues' questions 8 regarding the facility and all, can -- probably the 9 Applicant's the best idea.            In looking at some of the 10 slides -- it's actually from the first -- the overview 11 presentation,    can    you    give    me      an  idea  of      the 12 footprint, the area or size of the facility itself?
13 Because I've got picture, but it could be a doll house 14 or a large enrichment facility.                So just give me an 15 idea of the footprint.
16                MR. HENNESY:        The main building size is 17 around 55,000 square feet --
18                CHAIRMAN BURNS:          Okay.
19                MR. HENNESY: -- which is a little over an 20 acre in size. The whole site is 91 acres, so --
21                CHAIRMAN BURNS:          Yes.
22                MR. HENNESY: -- we're a dot in the middle 23 of a large area.
24                CHAIRMAN      BURNS:            Okay.      And        so 25 location-wise within that 91 acres are you sort of in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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129 1 the middle of it?          Is that the intention?
2                  MR. HENNESY:        Yes.
3                  CHAIRMAN BURNS: So you have a large -- in 4 fact      what  we'd    call    in    a    reactor      facility      the 5 owner-controlled area in that case?
6                  MR. HENNESY:        That's correct.
7                  CHAIRMAN BURNS:          Okay.      What is this --
8 and I'm looking and I just don't recall -- what is the 9 seismic design-basis for the facility?                        Either the 10 Applicant or the staff can respond to that.
11                  MS. KOLB:        The staff can -- or I mean 12 SHINE can respond to that.              I'd like to ask Alan Hull 13 to take that.
14                  CHAIRMAN BURNS:          Okay.
15                  MR. HULL:      Good morning.          My name is Alan 16 Hull.        I work for Golder Associates.                I'm a seismic 17 hazard specialist.
18                  CHAIRMAN BURNS:          And you were put under 19 oath earlier?
20                  MR. HULL:      I put under oath, yes, and I 21 took it.
22                  CHAIRMAN BURNS:          Please proceed.
23                  MR. HULL:          So    for      the  design-basis 24 earthquake you notice there were three stages.                        I can 25 comment only on the analysis that was done to come up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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130 1 with the ground shaking, and the structural engineer 2 for SHINE will able to talk about how that flowed on 3 into the actual design of the facilities.
4                    From our analysis we found that this part 5 of the United States is one of the lowest seismic 6 hazards in the area.            In fact, there were only about 7 58 earthquakes within 200 miles in the last 200 or so 8 years.        So when we looked at where the seismic design 9 should come from, we analyzed all those facilities as 10 we might have done for a power reactor.
11                    CHAIRMAN BURNS:          Yes.
12                    MR. HULL:      And by looking at the United 13 States geological survey seismic hazard model for the 14 United States we determined that a magnitude 5.8 15 earthquake        is  the    likely      design-basis    or  maximum 16 earthquake for this facility.                  The standard is about 17 0.2 g.
18                    CHAIRMAN BURNS:          Okay.
19                    MR. HULL:      That's 20 percent of the force 20 of gravity.          We looked at that seismic hazard model 21 for the United States and found that has a return 22 period of about 20,000 years.
23                    CHAIRMAN      BURNS:            Okay. And        my 24 recollection from a long time ago dealing with some 25 other facilities is that 0.2 g -- the shaking force is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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131 1 more or less equivalent to what I think a number of 2 the other reactors are designed for.
3                  MR. HULL:      That's my understanding.              And 4 my understanding also -- and again, a structural 5 engineer from Sargent & Lundy could provide more 6 detail.        My understanding is that that value of 0.2 g 7 is being used for the structural design of the Quality 8 1 facilities.
9                  CHAIRMAN BURNS: Okay. All right. Thanks 10 very much.
11                  The other thing is I'd ask the Applicant; 12 and the staff can certainly add, is what analysis of 13 flooding hazards were done with respect to the site?
14 And again, I know nothing of the site, so it may be a 15 silly question and it may not be.                    But, please.
16                  MS. KOLB:        We did do flooding hazards 17 analysis.          We  looked      at    the      probable  maximum 18 precipitation events and the probable maximum flood.
19 The Rock River is about two miles from the sites, but 20 the difference in elevation from the site elevation to 21 the Rock River, even in the probable maximum flood 22 situation, is still about 50 feet below the elevation 23 of the sites.          So that was determined to not pose a 24 hazard to the facility.
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132 1 based on the area of the sites, it comes up to about 2 the elevation of the site and the probable maximum 3 precipitation events, which we did analyze, but it 4 does not flood the structure.                And if you'd like more 5 detail, we have a geotechnical engineer from Golder 6 that could answer, provide more detail.
7                  CHAIRMAN BURNS:          I think that's good for 8 now.      Thank you.
9                  The final question I'll have here is with 10 respect to any analysis that were done with respect to 11 control or mitigation of release of tritium from the 12 facility since it does use tritium, and that's been an 13 issue, and it may be again.              Because of the design it 14 may not be as much of an issue for you all, but it has 15 been an issue at some nuclear power plant sites.
16                  MR. HULL:        Yes.      Yes, as I mentioned 17 before, we have a tritium purification system and the 18 accelerators themselves use a tritium gas target.
19 There are number of features there to control and 20 prevent the release of tritium to the environment.
21 One of the primary ones is that second confinement 22 barrier, the double-walled pipe around the tritium 23 piping.        And the tritium processing equipment is in 24 glove boxes, and those glove boxes are continuous 25 scrubbing of the atmosphere to remove tritium from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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133 1 atmosphere,        the    glove      box      and    maintain      that 2 concentration extremely low.                And any discharges from 3 the glove box are monitored and ensured that they're 4 below acceptable limits.
5                  CHAIRMAN BURNS:          Okay.        Thank you very 6 much.        Thank you. Commissioner Svinicki?
7                  COMMISSIONER SVINICKI:              Thank you all for 8 your presentations. I just have one question. It can 9 be either the staff or the Applicant and which subject 10 matter expert I guess gets to a microphone more 11 quickly, because it's kind of a background question.
12                  10 CFR Part 50, Appendix B QA Program 13 requirements are of course are applicable to power 14 reactors, so they are not in the strictest sense 15 applicable        to    the      SHINE      construction        permit 16 application.          SHINE's      slide      3    states  that      the 17 application        was  prepared        in    accordance      with      the 18 criteria set forward in ANSI/ANS-15.8 QA for research 19 reactors.
20                  Could someone though who is familiar --
21 I'm more familiar with Appendix B and the component 22 elements of that.            What is it that is missing or 23 sacrificed in terms of not using Appendix B versus 24 using the ANSI/ANS standard?                  Both to my knowledge 25 provide for a graduated approach to QA requirements, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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134 1 so    is    there  any    QA    expert      of    the  staff    or    the 2 Applicant who could tell me kind of what is sacrificed 3 between the two? I assume that the Part B -- Appendix 4 B, I'm sorry, QA Program is more rigorous somehow.
5                    Well, I mean, maybe -- and the other 6 question would be; and maybe this will be a follow-up 7 or something to be answered at the end of the day, if 8 possible.        Are all the requisite elements that are 9 required in an Appendix B program for coverage of QA 10 --    are    those  same    elements      of    addressed    in    the 11 ANSI/ANS standard?
12                    MR. ADAMS:      I think I can --
13                    COMMISSIONER SVINICKI:              Okay. Thank you.
14                    MR. ADAMS:        -- take a try at that.                  So 15 indeed the research reactors follow ANS 15.8, which is 16 endorsed by Regulatory Guide 2.5, Quality Assurance 17 Requirements for Research and Test Reactors.                            This 18 standard        was  developed        by    the    ANS  15  Committee, 19 Research        and  Test      Reactor      Committee,      and    it    was 20 developed because Appendix B did not apply to research 21 reactors as written.
22                    The coverage areas are the same. In fact, 23 the ANS standard goes a little bit further because it 24 includes        additional      quality        assurance      area        of 25 experiments, which you don't see in power reactors.
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135 1 Also,        the  ANS    standard      was      written    with      the 2 realization        that    the    definition          of  SSCs    in    the 3 regulations was written for power plants and may not 4 be strictly applicable to research reactors.
5                    Are you sacrificing something?              The staff 6 does not believe so given the difference between power 7 reactors and research and test reactors. Based on the 8 Quality Assurance Program from SHINE, the answers to 9 RAIs and the scope of the standard, and also the 10 Interim Staff Guidance to NUREG-1537 we believe that 11 using        ANS  15.8    is    applicable          for  meeting      the 12 requirements in 50.34(a)(7) for a Quality Assurance 13 Program.
14                    COMMISSIONER SVINICKI:              Okay. Thank you.
15 That's a very complete answer.                    I don't require any 16 supplement to that.            Thank you, Mr. Chairman.
17                    CHAIRMAN BURNS: Okay. Well, thank you to 18 our morning panels for their presentations.                        We will 19 now adjourn until 1:30 p.m. and we'll take up Safety 20 Panel 2.
21                    (Whereupon, the above-entitled matter went 22 off the record at 11:59 a.m. to reconvene at 1:30 23 p.m.)
24                    CHAIRMAN BURNS:            Okay, we'll call the 25 afternoon        session    of    the    hearing        on  the    SHINE NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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136 1 application to order for a Construction Permit.
2                    I'll ask the -- well, actually, what we'll 3 do, we'll hear both from the Applicant and then we'll 4 hear from the staff.              The staff can stay where they 5 are for the time being.
6                    But, we'll proceed with this afternoon's 7 panel.        I'll remind the witnesses that they are under 8 oath and ask you to introduce yourselves again as we 9 being the afternoon session.                        And then, you can 10 proceed.
11                    MR. COSTEDIO:        I'm Jim Costedio.      I'm the 12 SHINE Licensing Manager.
13                    MR. HENNESY: Bill Hennesy, the Manager of 14 Engineering for SHINE.
15                    MS. KOLB:          Catherine      Kolb,  I'm      an 16 Engineering Supervisor.
17                    MR. VAN ABEL:        Eric Van Abel, Engineering 18 Supervisor.
19                    CHAIRMAN BURNS:          Okay, please proceed.
20                    MR. COSTEDIO:        Good afternoon.
21                    For Safety Panel 2, I'd like to discuss 22 the Accident Analysis as presented in SHINE's PSAR.
23                    The basis for identification of accidents 24 for our PSAR was a Hazards and Operability Study.                        We 25 performed the HAZOPS, a Preliminary Hazards Analysis, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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137 1 a PHA. Both of those are rolled up into an Integrated 2 Safety Analysis.
3                  We also used the events from NUREG-1537 4 and the ISG augmenting NUREG-1537.
5                  We used the experience of our hazards 6 analysis team which included folks experienced in 7 nuclear plant operations and engineering personal 8 experience in reactor and nuclear process safety.
9                  Personnel familiar with process hazards 10 analysis and safety analysis modeling and methods, 11 personnel experienced with risk analysis and SHINE 12 system engineers familiar with the details of SHINE's 13 processes.
14                  And, this analysis was all done based on 15 our preliminary design information and we do expect to 16 update it with detail design and submit an updated 17 safety        analysis      with      our      Operating  License 18 Application.
19                  We  performed        qualitative      evaluations 20 within categories of accidents and then preformed 21 quantitative evaluation on the limiting accidents 22 within those categories.
23                  We also postulated a Maximum Hypothetical 24 Accident which is typical of the research reactor 25 community.        And that MHA was postulated for both the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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138 1 IF and the RPF.        And, I'll discuss both of those on 2 the next couple of slides.
3                  Next slide, please?
4                  In the IF, the MHA that we postulated was 5 a rupture of the target solution vessel and its 6 secondary vessel, the SASS, that surrounds it.                        So, 7 both of those vessels rupture, the target solution is 8 undergoing a radiation and spills into the IU cell.
9                  We ignore the pool.              This is all under 10 water, if you remember, and if we ignore that presence 11 in the pool so the material just spills and disburses 12 into the air.
13                  The high radiation is detected in the IU 14 cell and that initiates isolation of the cell and 15 evacuation alarms for personnel.
16                  The exhaust is filter through HEPA filters 17 and      charcoal  absorbers        and    the    calculated    dose 18 consequences from that event are 3.1 rem TEDE to the 19 work and 17 millirem at the fence for the public.
20                  Next slide, please?
21                  In the RPF, the MHA that we postulated was 22 found to have consequences more limiting than the IF 23 MHA, therefore, we designated the facility MHA.                    And, 24 that event was the rupture of the noble gas storage 25 tanks in the noble gas removal system.
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139 1                  Those tanks store the off gas from those 2 eight irradiation units after the irradiation cycle.
3 It's store there for decay and we postulated all five 4 of those tanks shown in blue on the figure on the 5 right          there,      rupture          simultaneously            and 6 instantaneously.
7                  The radiation in the room then initiates 8 confinement of that cell and high radiation alarms to 9 initiate evacuation.
10                  Some    material      bypasses      the  isolation 11 dampers and exposes and gets into the ductwork and 12 eventually to the public and some material leaks 13 through penetrations and exposes the workers.
14                  Next slide, please?
15                  The dose consequences for this event were 16 calculated to be 3.6 rem TEDE to the worker and 82 17 millirem at the fence for the public.
18                  These consequences were calculated in a 19 conservative manner.              There's several significant 20 conservatisms including a simultaneous instantaneous 21 rupture        of  these      five    tanks.        These  will        be 22 seismically designed, safety-related tanks with proper 23 isolation between the tanks, so we would not expect 24 multiple tanks to rupture.
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140 1 there's additional isolation dampers in the exhaust 2 ductwork that would trap a large fraction of these 3 radionuclides later on before they get out to the 4 exhaust duct.        But, those isolation dampers were not 5 credited in the analysis.
6                    So,  the      dose    consequences        would        be 7 significantly        lower      than    those        calculated    here.
8 However, the consequences are within the limits of 10 9 CFR 20.1101, 1201 and 1301.
10                    And, the figure on the right there shows 11 the dose from the SHINE accident on the left most bar.
12 The center bar is the 10 CFR 20 limit and the bar on 13 the right is the 10 CFR 50.34 dose guidelines for 14 power reactors for comparison.
15                    And, that concludes my presentation.
16                    CHAIRMAN BURNS:          Thank you.
17                    Now, we'll as the staff witnesses to come 18 forward.
19                    And,    I'll    remind        the    witnesses      that 20 they're under oath and I assume you all took the oath 21 earlier today, correct? Yes, and I want to remind you 22 you're        under  oath    and    why    don't      we  begin      with 23 introductions of the witnesses?
24                    MR. MORRISSEY:        I'm Kevin Morrissey.
25                    MR. LYNCH:      Dave Lynch.
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141 1                  MR. STAUDENMEIER:              Joe  Staudenmeier, 2 Senior Reactor Systems Engineer, Office of Research.
3                  CHAIRMAN BURNS:          Okay, thanks.        Please 4 proceed.
5                  MR. LYNCH:      So, this panel will discuss 6 the unique accident analyses considerations for the 7 SHINE Utilization and Projection Facilities.
8                  I'll    provide      an    introduction      to      the 9 staff's review methodologies.                  Joe Staudenmeier and 10 Kevin Morrissey will then discuss the specific details 11 of the staff's review and findings.
12                  Next slide, please?
13                  Based on the anticipated hazards at the 14 SHINE facility, two methodologies were applied to 15 postulated accident scenarios.                  Postulated accidents 16 at the SHINE facility were evaluated against the 17 radiological exposure limits in 10 CFR Part 20.
18                  Therefore, the SHINE workers are limited 19 to a total effective dose equivalent of five rem per 20 year      while  individual      members        of  the  public      are 21 limited to 100 millirem per year.                  This is consistent 22 with        the  exposure      limits      at      existing  research 23 reactors.
24                  The limiting radiological accident at the 25 SHINE        facility  is    referred        to    as  the  Maximum NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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142 1 Hypothetical Accident, or MHA.
2                  The MHA assumes a failure that results in 3 radiological releases and consequences exceeding those 4 of any postulated credible accident. The radiological 5 consequences resulting from the MHA are acceptable if 6 the resulting doses to workers and the public are less 7 than 10 CFR Part 20 exposure limits.
8                  In  addition        to  radiological      exposure 9 considerations, the radioisotope production facility 10 accident analysis used consequence and likelihood 11 criteria for potential accidents resulting in chemical 12 exposures.
13                  The staff evaluated SHINE's preliminary 14 radiological      and    chemical        consequence      likelihood 15 criteria, safety features and methods of assuring the 16 availability and reliability of safety features.
17                  Since the processes and hazards associated 18 with the SHINE radioisotope production facility are 19 similar to those at fuel cycle facilities.                  The staff 20 determined      that  SHINE's        use  of    integrated    safety 21 analysis methodologies as described in 10 CFR Part 70 22 is an acceptable way of both selecting the MHA and 23 demonstrating safety.
24                  Joe Staudenmeier will now discuss the 25 accident      analysis      considerations          for  the      SHINE NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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143 1 radiation facility.
2                  MR. STAUDENMEIER:          Thanks, Steve.
3                  The SHINE irradiation units operate at low 4 power and low pressure and, therefore, have low forces 5 to drive a radiological release.
6                  The target solution vessel and criticality 7 safe dump tank sit in a large pool of water that 8 provides passive decay heat removal.
9                  The    irradiated        target      solution        and 10 associated fission products and the tritium used in 11 the      accelerators    are    the    sources      of  radioactive 12 material that could be released during an accident.
13                  Next slide, please?
14                  SHINE has proposed and analyzed a set of 15 postulated accidents that should be representative of 16 the range of events that might happen in an operating 17 facility.      Postulated accidents provide insights into 18 the challenges to the safety systems of the facility.
19                  SHINE also analyzed how the potential 20 accidents      might    be    prevented          or  mitigated        by 21 administrative controls, engineered safety features 22 and trained personnel actions.
23                  The dose consequences were calculated to 24 determine the limiting accident.
25                  Next slide, please?
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144 1                  A typical SHINE accident scenario involves 2 a radioactive release into the irradiation unit pool 3 or atmosphere. The atmosphere in the irradiation unit 4 is connected by ducts to the ventilation system.
5                  There are isolation dampers on the ducts 6 that close in the event of a high radiation signal.
7 Workers are evacuated on a high radiation alarm.
8                  The releases reach the outside environment 9 after        passing  through      filters.        The calculated 10 releases are small enough that an acceptable emergency 11 planning zone could be the operational boundary.
12                  Next slide, please?
13                  The limiting accident for the irradiation 14 facility is a large rupture of one target solution 15 vessel.        The target solution and associated fission 16 products are released and no credit is given for 17 fission product scrubbing by the pool.
18                  The dose consequences from the limiting 19 accident in the irradiation facility are bounded by 20 the limiting accident in the radioisotope production 21 facility.
22                  This accident is a rupture of all noble 23 gas removal system storage tanks where gas is produced 24 in the irradiation process or stored while short-lived 25 radioisotopes decay.
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145 1                The  calculated          total      effective      dose 2 equivalent is 3.59 rems for workers, 82 millirems for 3 members of the public at the site boundary and less 4 than 12 millirems at the nearest residence.
5                The calculated doses meet the 10 CFR Part 6 20 acceptance criteria of five rem for workers and 100 7 millirem for members of the public.
8                Kevin Morrissey will now provide details 9 on the staff's evaluation of SHINE's radioisotope 10 production facility accident analysis.
11                Next slide, please?
12                RM. MORRISSEY:        Thank you, Joe.
13                In order to satisfy the 50.34 requirement 14 that a preliminary safety analysis report must assess 15 the risk to the public health and safety, SHINE 16 performed      an  Integrated        Safety        Analysis  of      the 17 radioisotope production facility.
18                This analysis included radiological and 19 chemical hazard and accident analyses for this portion 20 of the facility.
21                The  accident        analyses        determined      the 22 facility hazards that needed to be protected against 23 and help establish the design basis for this area.
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146 1 production facility incorporated adequate capabilities 2 and      features  to    prevent      or      mitigate  potential 3 accidents and to protect the health and safety of the 4 facility workers and the public.
5                  The staff's evaluation included review of 6 the following, the integrated safety analysis team, 7 the hazard evaluation process, the integrated safety 8 analysis        methodology,          the        completeness        of 9 identification of credible accident sequences, defense 10 in depth features of the design and safety related 11 design features such as process cells and facility 12 structures.
13                  Next slide, please?
14                  The staff reviewed multiple accident event 15 types such as radiological accidents including tank or 16 pipe failures and equipment malfunctions, chemical 17 accidents      including      tank    or    vessel    failures      and 18 exothermic reactions, criticality accidents, fires and 19 external events.
20                  The review of SHINE's non-radiological 21 accidents included chemical safety related accidents 22 and determination of chemical safety controls.
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147 1 chemicals produced from licensed material.
2                The staff also reviewed chemical risks of 3 plant conditions that affect the safety of licensed 4 material.
5                The    staff        determined        that    SHINE's 6 preliminary      facility        design        proposed    process 7 operations and safety controls for radiological and 8 chemical safety will perform their expected safety 9 function as intended and, thus, they will be adequate 10 to      protect  public      health      and      safety  and      the 11 environment.
12                The staff concludes that, for the purposes 13 of issuing a Construction Permit, there is reasonable 14 assurance      that  the    proposed      preliminary      accident 15 analysis of the SHINE facility adequately assessed the 16 risk to public health and safety.
17                The analysis also acceptably supports the 18 determination      of    the    facility        hazards    in      the 19 preliminary safety design including the engineered 20 safety features that protect the health and safety of 21 workers and the public.
22                This  concludes        the      staff  remarks      for 23 Safety Panel 2. And we are prepared to respond to any 24 questions at this time.
25                CHAIRMAN BURNS:          Okay, thank you.
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148 1                  What I'd ask the staff witnesses do is 2 maybe, Mr. Staudenmeier, if you can move to that seat, 3 move      a  little  closer      to    the      secretary  and      Mr.
4 Morrissey and Mr. Lynch and this way then we can all 5 see each other -- good visual from there and maybe 6 just a little bit closer to the secretary.                        That's 7 good, that's good.
8                  I  believe      we    start        the  questioning, 9 Commissioner Baran.
10                  COMMISSIONER BARAN:            Thanks.
11                  Steve and Joe, I wanted to -- now you're 12 very far apart -- but, I wanted to ask you about the 13 Maximum Hypothetical Accident for the irradiation 14 facility.
15                  As you mentioned, this involves failure of 16 one of the eight irradiation units.                    Now, in response 17 to pre-hearing questions five and six, the staff 18 stated that the irradiation units have been designed 19 to withstand any events that could cause multiple 20 units to fail simultaneously.
21                  That's a pretty strong statement and I 22 wanted to give you a chance to talk to us about how 23 you reached that conclusion.
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149 1 concrete shielding structures and they are designed to 2 withstand any design basis event like seismic or other 3 loadings on the system.          And, there's no real way for 4 a failure in one to trigger failures in others or a 5 chain reaction.
6                COMMISSIONER BARAN:            So, the staff looked 7 at tornados, earthquakes, floods, fires, aircraft 8 impacts, loss of offsite power and the staff concluded 9 that none of these events could cause more than one 10 irradiation unit to fail, is that right?
11                MR. STAUDENMEIER:              Well,  in terms      of 12 aircraft impact, the smaller aircraft that the type 13 that land at that airport, I know the facility is 14 designed to withstand impacts from those.
15                I don't think a large aircraft crash was 16 within the design basis of the facility.
17                COMMISSIONER BARAN: Okay, so with respect 18 to design basis events of those types?
19                MR. LYNCH:      Yes, that is correct.
20                COMMISSIONER BARAN:            Okay. Are there any 21 other kind of beyond design basis events besides 22 larger aircraft that you particularly have in mind 23 that could be an issue?
24                MR. LYNCH:      Not at this time, no.
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150 1 alluded to this a little bit, Joe, but are there --
2 could any of the common fill drain or off gas line 3 shared by the eight units result in an accident worse 4 than the Maximum Hypothetical Accident because of a 5 common mode failure?
6                  MR. STAUDENMEIER:          No, not that I'm aware 7 of.        I mean, there's one common mode failure for 8 cooling to the TOGS system, I think, in long term, but 9 the cells would be isolated by that time and SHINE was 10 going to look at that for, I think they had a survival 11 time of four hours maybe for power lasting and they 12 were going to look at that in the Operating License 13 Review.
14                  COMMISSIONER BARAN:            Okay. Well, let me 15 just give SHINE a chance if you wanted to add anything 16 on      the    Maximum    Hypothetical            Accident    for      the 17 irradiation units that the staff didn't cover.
18                  MR. VAN ABEL:          We did look at potential 19 for other events involving multiple units and we 20 didn't identify any potential events that would be 21 worse than the Maximum Hypothetical Accidents.
22                  COMMISSIONER BARAN:            Okay, thanks.
23                  Pre-hearing question 29 asked about safety 24 features for the transfer of the target solution to 25 the        radioisotope        production            facility      after NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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151 1 irradiation.
2                I'd    like      to    ask      the  staff,      what 3 criticality risks exist when the target solution is 4 transferred and how is that risk mitigated?
5                MR. LYNCH:      Yes, I think Chris Heysel did 6 a review on engineered safety features.                  If you would 7 like to say a few words on that?
8                CHAIRMAN BURNS: Again, identify yourself 9 and confirm that you were previously put under oath.
10                MR. HEYSEL:        For the record, my name is 11 Chris Heysel, I'm a Consultant with ISL.                  And, I did 12 take the oath earlier.
13                CHAIRMAN BURNS:          Please be seated.
14                MR. HEYSEL:        The engineering and safety 15 features are integral to both the IUs and the RPFs.
16 So, the both passive and active features will provide 17 the engineering safety features to mitigate normal and 18 offsite conditions.
19                The design of those features will control 20 a      criticality  accident        due      to    the  geometries 21 associated with them.
22                COMMISSIONER        BARAN:          And,  will      the 23 criticality accident alarm system include coverage for 24 the entire path that the target solution travels 25 during transfer?
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152 1                MR. HEYSEL:      I am not the correct witness 2 to talk about the criticality alarm system.
3                COMMISSIONER BARAN:            Okay.
4                Very quickly, anyone on the staff would 5 care to answer that?
6                MR. LYNCH:          Chris, would you like to 7 discuss the criticality accident alarm system and the 8 areas of coverage?
9                COMMISSIONER BARAN:            Just briefly.
10                CHAIRMAN BURNS:          Identify yourself.
11                MR. TRIPP: Chris Tripp and I did take the 12 oath.
13                Yes, we don't have the design details of 14 the criticality alarm system in detail.                    However, 15 SHINE has not identified any areas where they'd be 16 taking exceptions.
17                So,  anywhere      there      is  vessel  nuclear 18 material present, we understand that they would have 19 coverage of those areas.
20                COMMISSIONER BARAN:            Okay, great.      Thank 21 you.
22                Thanks, Mr. Chairman.
23                CHAIRMAN      BURNS:        I    had  a  couple      of 24 questions in terms of the review and the accident 25 analysis.
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153 1                What are, and I think SHINE and/or the 2 staff can address this, what are the most significant 3 natural hazards that you had to focus your design on?
4                MS. KANATAS:        I guess we can go first.
5                So, we looked at natural hazards involving 6 flooding, as I spoke about earlier today.            We looked 7 at the design basis aircraft, that's not really a 8 natural hazard, that's an external event.
9                We looked at the tornados, historical 10 maximum tornados.        We used guidance from Regulatory 11 Guide, I believe it's 176 for the -- that's used for 12 power reactors for the spectrum and the wind speeds 13 for tornados.
14                We looked at tornado missiles.        Anything 15 else I'm missing?      I mentioned flooding.
16                CHAIRMAN BURNS: Okay. And, staff, do you 17 want to add on to that, the one other thing that SHINE 18 did look at this as well in addition to staff was the 19 rain, snow load on the facility as well as an external 20 event?
21                MR. LYNCH:      In terms of the roof of the 22 building?
23                CHAIRMAN BURNS:          Yes, yes.
24                MR. LYNCH:      Okay.
25                CHAIRMAN BURNS:          Yes.
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154 1                MR. LYNCH:      Okay.
2                CHAIRMAN BURNS: There's just -- actually, 3 part        of our  discussion        focused      on  not      only 4 radiological hazards, but chemical hazards and, I 5 think in the description of the facility, for example, 6 sulfuric acid is used in part of the process.
7                What    are    the      significant    potential 8 chemical hazards that are involved with the facility?
9                MR. VAN ABLE:        For SHINE.
10                We looked at a variety of chemical hazards 11 in the facility.        We do have sulfuric acid, nitric 12 acid, other acids and bases.
13                We identified 24 chemicals of concern that 14 we use throughout the process and 11 of them were 15 explicitly modeled because of their -- either their 16 toxicity, their dispersibility or inventory. And that 17 includes things like the acids I mentioned, calcium 18 hydroxide,      caustic      soda,        ammonium    hydroxide, 19 N-dodecane, potassium permanganate, tributyl phosphate 20 which is part of the UREX process and uranyl nitrate 21 and a couple of proprietary chemicals as well.
22                CHAIRMAN BURNS:          Okay. From the -- go 23 ahead, Mr. Lynch.
24                MR. LYNCH:      Yes, I would just say as far 25 as the chemical hazards and concern, the staff is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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155 1 expecting hazardous chemicals to be in very small 2 quantities at the facility.
3                  The only chemicals that could exceed large 4 quantities which we're considering to be greater than 5 1,000 pounds would be nitric acid or sulfuric acid.
6 And, there are a number of processes that we are 7 evaluating that involve these chemical hazards and 8 this includes the preparation of the target solution 9 vessel, the radioisotope production, extraction and 10 purification system, target solution clean up and any 11 waste operations.
12                  CHAIRMAN BURNS:          Okay. In terms of the 13 control        of  those    types      of    hazards,    do  we    look 14 primarily to the regulatory footprint or authority of 15 other agencies or how is that integrated in terms of 16 what        the  staff      would      evaluate      in    terms        of 17 acceptability for both the Construction Permit, but 18 looking forward, if we came to a point of an Operating 19 License, what would we do?
20                  MR. MORRISSEY:            Well,    typically,        we 21 evaluate chemical hazards in Part 70 under 70.61. So, 22 we use that and SHINE, that is one acceptable way of 23 doing things and SHINE preferred to take that way.
24                  CHAIRMAN BURNS:          Okay.
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156 1 guidance        through    15.20    on,    you      know,  how  to      do 2 chemical safety evaluations.
3                    CHAIRMAN BURNS:            Okay.        And, just to 4 confirm my understanding on the Maximum Hypothetical 5 Accident that was described is, I understand, or the 6 slides        in  the  presentation,          in      that  event,      the 7 expectation would be that a worker dose would be less 8 than the normal occupational dose that is permitted 9 under Part 20, is that correct?                      I thought I heard 10 something like 3 point X rem.
11                    MR. VAN ABEL:        Yes.
12                    CHAIRMAN BURNS:          Okay.
13                    MR. VAN ABEL:        That's correct.
14                    CHAIRMAN      BURNS:        And      then,  the    site 15 boundary dose to the public would be 82 millirem as 16 opposed to the 100 millirem?                So, then what we're --
17 at least from our understanding at this point for 18 purposes of Construction Permit, is you have doses 19 that are actually below what we'll call normal dose 20 limitations?
21                    MR. LYNCH:      Yes, that is correct.
22                    CHAIRMAN BURNS:          Okay.
23                    There was a comment with respect to, and 24 again, looking forward, we're not deciding emergency 25 preparedness requirements in this context today, but NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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157 1 there was a comment made and I don't -- I think it may 2 have been one of the staff witnesses, but it may have 3 been SHINE, with respect to the size the -- or the, I 4 guess, not size but, perhaps, boundary of an emergency 5 planning        zone  was    described        as  the  operational 6 boundary.
7                    Can you describe for me what that means?
8 Does that mean the building or does that mean the 9 owner -- what I would call the owner controlled area?
10                    MR. LYNCH:      Yes, the operational boundary 11 would be the building itself.                  And, just to clarify, 12 that is something the staff is still evaluating as to 13 what in the Operating License.
14                    CHAIRMAN BURNS:          No, I understand, but I 15 appreciate that clarification.
16                    That's all I have.
17                    Commissioner Svinicki?
18                    COMMISSIONER SVINICKI:              Thank for your 19 presentations on this panel which were principally 20 regarding Chapter 13 Accident Analysis.
21                    In my preparation between reviewing the 22 record        itself  and    the    supplements      given  in    the 23 response to pre-hearing questions, I found there to be 24 a very complete and exhaustive discussion of the 25 Maximum Hypothetical Accident.                    So, I was satisfied NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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158 1 with answers to my questions on those points.
2                So, I do have two questions that relate to 3 Chapters 11 and 12.        And, Chapter 11 addresses waste 4 management issues.
5                This is for, I think both of my questions 6 will be for the Applicant witnesses.
7                SHINE has indicated that greater than 8 Class C low level waste would be generated as a result 9 of operating the facility, is that correct?
10                MS. KANATAS:        Yes, we do have that in our 11 PSAR.
12                COMMISSIONER SVINICKI:              Okay. So, my 13 question is, if there is no national disposal pathway 14 for your greater than Class C waste, would you have 15 adequate ability to store that on your site for the 16 lifetime of the operations of the facility?
17                MS. KANATAS:        Before I answer that --
18                COMMISSIONER SVINICKI:              If not, what is 19 your other alternative plan?
20                MS. KANATAS:          So, our designations of 21 greater than Class C waste are two small waste streams 22 and that's based on our preliminary design and some 23 conservative assumptions.
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159 1 as it stands, we've had discussions with some license 2 disposal facilities that have the ability to store 3 greater than Class C waste.
4                    If SHINE did not have a commercial path, 5 either        a waste  control      specialist        or  some    other 6 commercial disposal or storage facility, then the 7 provision of the American Medical Isotope Production 8 Act has a provision to accept the wastes from medical 9 isotope productions and that's what we would --
10                    COMMISSIONER SVINICKI:              And that --
11                    MS. KANATAS:        And      that  would  be    our 12 fallback position.
13                    COMMISSIONER SVINICKI: And that provision 14 in the Act is for the Department of Energy or U.S.
15 Government to take that waste?
16                    MS. KANATAS:        The Department of Energy, 17 that's correct.
18                    COMMISSIONER SVINICKI:              Okay, thank you.
19                    And then, broadly, Chapter 12 is conduct 20 of operations, but broadly, as SHINE looks to the 21 future and the possible need for qualified operators, 22 very conceptually, what do you envision as the skills, 23 knowledge and abilities of the types of experience 24 that a qualified operator for this type of facility 25 would have?          Is it someone who has operated power NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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160 1 reactors or research and test reactors? Would that be 2 in general the requisite skill set or is it only 3 requiring some sort of smaller set of knowledge skills 4 and abilities?
5                    MR. COSTEDIO:          I mean, certainly, we'd 6 entertain the hiring folks with prior power reactor 7 experience and that would be good. Also, nuclear Navy 8 and engineers out of college.
9                    We plan on having a training program in 10 accordance        with  NUREG-1478        for    research  and    test 11 reactors, that's on the license and operators.
12                    We do have to do some work, you know, with 13 the staff on that to line that up with what we do.
14 But, we certainly plan on having a rigorous SAT-based, 15 you know, training process with exams and very, very 16 similar to what the research and test reactors do now.
17                    COMMISSIONER SVINICKI: Would you envision 18 having        any  sort  of    partnership          with local    maybe 19 technical colleges or others to develop a kind of a 20 qualified worker base for this facility going forward?
21 Is that something you've thought about?
22                    MR. COSTEDIO:            Yes,      with  Blackhawk 23 College, we've talked with them.
24                    Do you have more?
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161 1 the local technical colleges.                      There's one up in 2 Northeast Wisconsin which is in partnership with the 3 one down by Janesville that has done a lot of training 4 for RP personnel to work at the power plants that are 5 up there.
6                  And    so,      they've          been    looking        at 7 transferring those programs down to the Janesville 8 area and we expect that will be very useful to us to 9 help find good staff to staff our facility.
10                  COMMISSIONER SVINICKI:              Okay, thank you.
11                  Thank you, Mr. Chairman.
12                  CHAIRMAN BURNS:          Thank you.
13                  Commissioner Ostendorff?
14                  COMMISSIONER OSTENDORFF:              Thank you, Mr.
15 Chairman.
16                  I'm going to start off with the Applicant, 17 please.
18                  I recognize in the unique nature of the 19 SHINE        is conceptually      looked      at    today,  is    there 20 anything in the radiation detection arena as far as 21 equipment monitoring instrumentation that you would 22 characterize as never tried before of first-of-a-kind 23 engineering or first-of-a-kind instrumentation?
24                  MR. VAN ABEL:        No, you know, have various 25 radiation area monitors in the facility, continuous NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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162 1 air monitors, standard off-the-shelf type technology.
2                  We're looking at neutron flux detectors to 3 monitor the activity in the neutron population in the 4 TSV radiation.
5                  And, we're talking to existing vendors who 6 supply research reactors with that technology and it's 7 all within normal --
8                  COMMISSIONER OSTENDORFF:                So, as far as 9 neutron detectors, you expect to be able to use some 10 technology that's already on the market for that?
11                  MR. VAN ABEL:            Oh, yes, yes, that is 12 correct.
13                  COMMISSIONER OSTENDORFF:                Okay.
14                  Real    quick,      did    the      staff  see      any 15 challenges        in  this      area      for      either  radiation 16 protection or detection device approaches?
17                  MR. LYNCH:        As of now, we have not.
18                  COMMISSIONER OSTENDORFF:                Okay.
19                  All right, let me go back to the Applicant 20 just for real quick.
21                  On your slide four, several times there's 22 reference to the isolation dampers.                      I know dampers 23 are      pretty  straightforward,          but      dampers    can      be 24 complex.      And, are these manually operated?                Are they 25 operated by some solenoid or hydraulic system or can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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163 1 you talk about, in an accident scenario, how they'd be 2 operated?
3                  MR. VAN ABEL:          We haven't selected the 4 dampers yet.          They would not be manual operated, 5 they'd        be operated      by    some    actuation      mechanism, 6 hydraulic or pneumatic.
7                  We've looked at vendors that supply these 8 for the nuclear industry and there are many traces 9 available that we think will meet our criteria, but 10 they would be automatic actuated by the safety systems 11 and there would be fail close so their fail position 12 would be closed if you lose offsite power, they would 13 close automatically.
14                  COMMISSIONER OSTENDORFF:              And the use of 15 the word redundant in front of isolation dampers, does 16 that mean there's more than one damper in the flow 17 path of the ventilation?
18                  MR. VAN ABEL:        It means -- yes, not only 19 there would be two dampers, but every place that you 20 need an isolation capability.
21                  COMMISSIONER OSTENDORFF: All right, thank 22 you.
23                  I have no further questions.
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164 1 Commissioner Baran again, to redo a round, but I take 2 it without anything else, we'll dismiss this panel.
3                Thank you for your testimony and we'll 4 call up the environmental panel.
5                (Whereupon, the above-entitled matter went 6 off the record at 2:06 p.m. and resumed at 2:08 p.m.)
7                CHAIRMAN BURNS:          Well, thank you, again.
8                And, we'll, again, with this panel, we'll 9 have the testimony of the Applicant and then the staff 10 testimony, then proceed to questioning.
11                Again, I remind all the witnesses that 12 they remain under oath and I'll ask you, when you 13 start again and ask you to introduce yourselves, first 14 for the SHINE witnesses.
15                MS. PITAS:      Certainly.          My name's Katrina 16 Pitas. I'm the Vice President of Business Development 17 for SHINE.
18                CHAIRMAN BURNS:          Okay.
19                MR. HENNESY:          Bill Hennesy, Manager of 20 Engineer for SHINE.
21                MS. KOLB:        Catherine Kolb, Engineering 22 Supervisor.
23                MR. KRAUSE:          I'm Tim Krause.          I'm an 24 Environmental Coordinator for the project.
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165 1 all start?
2                  MS. PITAS:      Thank you.
3                  So, I'm going to give the environmental 4 overview for SHINE today.
5                  Next slide, please?
6                  On this first slide, you will see some 7 pictures of some of the site characterization work 8 that was done.        We began that work back in October of 9 2011 at the Janesville site which was chosen for the 10 SHINE facility.
11                  And, we did that site characterization 12 work      to  develop    the    environmental          report    which 13 followed the final Interim Staff Guidance augmenting 14 NUREG-1537.
15                  Next slide, please?
16                  This table shows the structure and the 17 content        of  the    Environmental            Report.      After 18 introducing the project, the Environmental Report goes 19 on to discuss the proposed action.                    It then goes into 20 a      detailed    description        of    the      affect  in      the 21 environment and the resources of the chosen site, 22 Janesville.
23                  Then, it goes on to analyze both the 24 impacts and the benefits of the SHINE technology on 25 the chosen site.
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166 1                    And then, it compares the impacts of the 2 SHINE technology at the Janesville site with the 3 impacts of the no-action alterative, what the impacts 4 of the SHINE technology would be at two alternative 5 sites, Chippewa Falls and Stevens Point.
6                    And then, it looks at the impacts of two 7 alternative technologies.
8                    It then goes on to discuss the conclusions 9 reached by the report.
10                    Next slide, please?
11                    The field investigations we needed to do 12 to      gather      the    information            to    complete        the 13 environmental report were thorough and very extensive.
14                    In addition to a Phase I environmental 15 site assessment and general site reconnaissance, the 16 geotechnical        investigation          consisted      of  15    soil 17 borings,        one    of    which      was      used  for    seismic 18 characterization, four of which were converted to 19 groundwater monitoring wells.
20                    A Phase I archaeological investigation, a 21 baseline visual assessment and a wetland delineation 22 were        all    performed        as    well      as    ecological 23 investigations        that      consisted        of  quarterly      field 24 surveys over the course of one year.                    Those looked at 25 both aquatic ecology and terrestrial ecology.
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167 1                  And, monthly ground and surface water 2 monitoring that looked at both water quality and water 3 levels.
4                  Next slide, please?
5                  The  context      for    our      data acquisition 6 varied depending on which resource was being analyzed.
7 Many of the investigations looked just at the SHINE 8 parcel itself which, as has been mentioned, is a 9 91-acre        parcel  on    the    south    side    of Janesville, 10 Wisconsin.
11                  Some of the investigations looked a little 12 bit broader at the project area which we consider to 13 be the one mile radius from the site center point.
14                  And then, other investigations looked at 15 the entire region surrounding the SHINE site, often up 16 to five miles in all directions from the center point.
17                  And then, for some of the resources like 18 geology and air quality, we looked at even larger 19 contexts as was appropriate to the resource.
20                  For socio-economic impacts, we looked at 21 what is known as the region of influence.                            That 22 corresponds to the area that incurs the greatest 23 impacts to community services that result from the 24 SHINE facility and the people who work at the SHINE 25 facility.        We determined that to be Rock County, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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168 1 Wisconsin.
2                  Next slide, please?
3                  We    also      conducted          a  number        of 4 consultations in preparation for the environmental 5 report.
6                  We talked to the City of Janesville, Rock 7 County, the Wisconsin Department of Natural Resources, 8 the Wisconsin State Historic Preservation Office, the 9 Wisconsin Department of Transportation, the U.S. Fish 10 and        Wildlife    Service,        the        Federal  Aviation 11 Administration, the Bureau of Indian Affairs and we 12 also contacted 13 Native American Tribes including two 13 Tribes located within the State of Wisconsin and 11 14 Tribes that were non-Wisconsin Tribes.
15                  Next slide, please?
16                  In addition to the impacts of constructing 17 and operating the SHINE facility at the Janesville 18 site, SHINE analyzed two alternative sites and the 19 no-action alternative.
20                  The SHINE project, as has been discussed, 21 results in a number of local, national and global 22 benefits.      These include the socio-economic benefits 23 for the local community consisting of tax benefits and 24 increased job opportunities.
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169 1 U.S.        Government    policies      to      encourage    domestic 2 production of medical isotopes and nonproliferation.
3                  But,    most    of    all,      the  SHINE  project 4 results in health benefits from a reliable, stable 5 supply of technetium-99m, for patients around the 6 globe.
7                  So,  in    light      of    these    benefits,      the 8 no-action        alterative      is    not      preferable    to      the 9 construction and operation of the SHINE facility.
10                  Although the no-action alternative would 11 avoid the environmental impacts associated with the 12 SHINE project, because all of these impacts are small 13 for the SHINE technology, avoiding these impacts is 14 not significant.
15                  And, the no-action alternative would not 16 impart the important benefits that I mentioned before.
17                  Looking at the two alternative sites, 18 Chippewa Falls and Stevens Point, neither alternative 19 site would reduce or avoid adverse impacts as compared 20 with the SHINE site.
21                  As shown in this table, the Janesville 22 site is the preferred site from an environmental 23 perspective, given that it has small impacts to all 24 resource        categories      while      the      alternatives      had 25 moderate impacts to some resource categories during NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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170 1 construction.
2                Next slide, please?
3                SHINE      also      analyzed      two  --      the 4 environmental impacts of two alternative technologies, 5 both the linear accelerator technology that would be 6 creating moly-99 from enriched or natural molybdenum 7 targets and a low enriched uranium aqueous homogeneous 8 reactor.
9                Both of these technologies are considered 10 reasonable alternatives to the SHINE technology for 11 the Janesville site from an environmental perspective.
12 But, neither of the alternative technologies would 13 reduce or avoid adverse impacts as compared with the 14 SHINE technology.
15                Next slide, please?
16                In mid-2013, the NRC staff conducted an 17 environmental    site    audit.        SHINE    gave the    staff 18 presentations on the SHINE technology and our site 19 selection process.
20                The staff then made a number of visits to 21 places of interest in the community.                Those included 22 the Janesville site and the surrounding area. We went 23 on a driving tour of about 4.4 miles around the site.
24                We visited the Rock River. We visited the 25 sites that were used for sampling along the nearby NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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171 1 unnamed        tributary.        We    visited        the  Janesville 2 Wastewater Treatment Facility which included a look at 3 the outfall structure to the Rock River.
4                  And, we looked at both alternative sites.
5 We traveled both to Stevens Point and the Chippewa 6 Falls.
7                  Next slide, please?
8                  SHINE believes the relationships between 9 the company, the City of Janesville and the State of 10 Wisconsin are incredibly important and we worked very 11 hard      to  build  and    continuously          strengthen    those 12 relationships        via    a  policy      of      transparency      and 13 frequent engagement.
14                  Supporting these principles, we ensure a 15 minimum of four public meetings with the community per 16 year, as I had mentioned earlier.                  And, actually, the 17 most recent of those happened on December 9th.
18                  As a result of these activities and these 19 efforts, we have a relationship with the community 20 that's based on trust, mutual respect and, I believe, 21 genuine enthusiasm for the SHINE project.
22                  Next slide, please?
23                  In conclusion, the SHINE environmental 24 review was conducted pursuant to 10 CFR Part 51 and is 25 adequate.        The requirements of Sections 102.2(a), (c)
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172 1 and (e) of the National Environmental Policy Act have 2 been satisfied and SHINE's weighing and balancing of 3 the      environmental,    technical      and    other  costs      and 4 benefits of the SHINE facility supports issuance of 5 the Construction Permit.
6                Thank you.
7                CHAIRMAN BURNS:          Okay, thank you.
8                We'll proceed now with the staff testimony 9 and I'd ask the staff witnesses to identify themselves 10 and then you can proceed.
11                MS. MARSHALL:        My name is Jane Marshall.
12 I'm the Deputy Director for the Division of License 13 Renewal in the Office of Nuclear Reactor Regulation.
14                MR. WRONA:      I'm David Wrona, the Chief of 15 the Environmental Review Branch in the Office of NRR.
16                MS. MOSER:        My name is Michelle Moser.
17 I'm the Environmental Project Manager in NRR.
18                CHAIRMAN      BURNS:            Okay,  thank      you.
19 Proceed.
20                MS. MARSHALL:        Okay, thanks.
21                If I can have -- you've got my slide, 22 thank you.
23                Good afternoon.          I'm Jane Marshall and 24 with me today to discuss the environmental review of 25 the SHINE facility are Dave Wrona and Michelle Moser.
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173 1                  Next slide, please?
2                  As I mentioned during my presentation 3 earlier this morning, part of the staff's review of 4 the SHINE Construction Permit Application included an 5 environmental review which was conducted in parallel 6 with the safety review that you heard about earlier 7 today.
8                  The  staff    performed        the  environmental 9 review in accordance with the National Environmental 10 Policy Act of 1969, commonly referred to as NEPA.
11                  In  doing    it's    NEPA      review,  the    staff 12 followed        the    environmental          review      process      for 13 preparing an Environmental Impact Statement, commonly 14 referred to as an EIS, as described in 10 CFR Part 51 15 and      in  the    Interim      Staff        Guidance    augmenting 16 NUREG-1537.
17                  The following presentations provide an 18 overview of the environmental review for the SHINE 19 Application while highlighting the unique aspects of 20 this review.
21                  The  three    novel      issues    that  we    will 22 highlight      today    include      the    staff's    decision      to 23 prepare an EIS, the inclusion of the Department of 24 Energy as a cooperating Agency and the NRC staff's 25 analysis      to    determine        the    range      of  reasonable NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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174 1 alternatives analyzed in the EIS.
2                  And now, I turn it over to Dave Wrona.
3                  MR. WRONA:      Thank you, Jane.
4                  One    of    the      first      steps  in      the 5 environmental      review      process      was    determining      the 6 appropriate methodology for the environmental review 7 and the level of detail for staff findings.
8                  Environmental          reviews      for  licensing 9 actions fall into one of three categories, those 10 identified as categorical exclusions and not requiring 11 further evaluation, those requiring the preparation of 12 an environmental assessment, commonly referred to as 13 an EA and those requiring the preparation of an EIS.
14                  Licensing actions that require and EIS are 15 described in 10 CFR 51.20.              The proposed issuance of 16 a    Construction    Permit      for    a    medical    radioisotope 17 production facility is not specifically listed in 10 18 CFR 51.20.
19                  Such licensing actions would require an EA 20 or an EIS, depending on project-specific activities 21 and site-specific conditions that could impact the 22 actions potential to significantly affect the quality 23 of the human environment.
24                  After    reviewing        SHINE's      environmental 25 report,        the    staff        made        a    project-specific NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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175 1 determination that an EIS would be appropriate to 2 assess        the  environmental        impacts        of  the  proposed 3 action.
4                    This determination was made because of the 5 potential for potential significant impacts and unique 6 considerations of a first-of-a-kind application for a 7 medical        radioisotope      production          facility    using      a 8 unique application of technologies.
9                    The EIS process also allowed for multiple 10 opportunities          for      public      involvement          in      the 11 environmental review.
12                    In the EIS, we evaluated potential impacts 13 from      the    proposed      action,      that      is,  the  proposed 14 construction of the SHINE facility.
15                    Consistent          with        the      Council          on 16 Environmental Quality's regulations implementing NEPA, 17 the staff considered connected or related actions and 18 evaluated the potential impacts from operations and 19 decommissioning.
20                    A discussion of potential impacts from 21 operations          is    also      consistent            with    previous 22 environmental          reviews      conducted        by    the  staff      for 23 Construction Permit Applications, such as the Final 24 Environmental Statements for the Columbia Generating 25 Station and for Arkansas Nuclear One.
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176 1                  Next slide, please?
2                  After publishing the Notice of Intent to 3 Prepare an EIS, the environmental review started with 4 the 60-day scoping period.              Scoping is the process by 5 which the staff identifies the specific impacts and 6 significant issues to be considered in the preparation 7 of the an EIS.
8                  During    this    time,      we    held  two    public 9 scoping meetings in Janesville, Wisconsin to gather 10 input from the public, federal, state, local agencies 11 and tribes regarding issues to consider in the EIS.
12                  Five attendees provided oral statements at 13 the public scoping meetings, including members of the 14 public, a member of the Janesville City Council and a 15 representative from Congressman Mark Pocan's office.
16                  In  addition,        the      staff    received        six 17 written        letters  from      members      of    the  public,        the 18 Wisconsin Department of Natural Resources, the U.S.
19 Environmental Protection Agency and the Forest County 20 Potawatomi community.
21                  The comments were related to a variety of 22 environmental issues including the potential from 23 aircraft or from accidents due to aircraft collisions, 24 potential contamination to groundwater and nearby 25 agricultural        lands,      conversion          of  farmland        and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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177 1 alternative sites and technologies.
2                  The  staff      responded          to  all  comments 3 received      during    the    scoping      period    in  a  Scoping 4 Summary Report. It included relevant information from 5 in scope comments and the draft EIS.
6                  Next slide, please?
7                  Another part of the scoping process was to 8 determine if other governmental agencies had expertise 9 or jurisdiction over the proposed project.
10                  For  SHINE,      two    federal      agencies      were 11 obligated to conduct environmental reviews.
12                  NEC    was      required          to  conduct        an 13 environmental review to decide whether to grant SHINE 14 a Construction Permit.
15                  The Department of Energy, or DOE, was 16 required      to  conduct      an    environmental        review      for 17 providing financial support to SHINE.
18                  Our  coordination        with      DOE  is  another 19 unique aspect of this review.                The coordination with 20 DOE was unique for two reasons.
21                  First, the NRC typically does not consult 22 with DOE to our separate roles and responsibilities.
23                  Second,      the    American        Medical  Isotopes 24 Production Act directs the DOE and the NRC to ensure 25 to the maximum extent practicable that environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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178 1 reviews        for    facilities          to        produce    medical 2 radioisotopes are complimentary and not duplicative.
3                    Therefore,      NRC      and      DOE  developed        a 4 Memorandum        of  Agreement        to    make      effective      and 5 efficient use of federal resources during the review 6 of the SHINE Construction Permit Application.
7                    The goal of the agreement was to develop 8 a single EIS that would evaluate the impacts of NRC's 9 licensing process and the DOE funding process.
10                    The Memorandum of Agreement designates the 11 NRC      as  the  lead    federal      agency      and  DOE    is    a 12 cooperating agency for developing the EIS for the 13 proposed SHINE facility.
14                    Under NEPA, the lead agency, or NRC in 15 this case, has the primary role in preparing the EIS 16 while the cooperating agency, DOE, is responsible for 17 assisting in the development.
18                    Michelle      Moser    will      now  describe      the 19 preparation of the EIS and the staff's conclusions.
20                    MS. MOSER:      Thanks, Dave.
21                    In developing the EIS, the staff reviewed 22 the information included in SHINE's environmental 23 report, visited site, considered scoping comments and 24 conducted an independent review to characterize the 25 environmental        features        at    the      proposed    site        in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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179 1 Janesville, Wisconsin.
2                  The environmental resources described in 3 the EIS includes aspects of both the human and natural 4 environment        such    as    ecological          resources,    water 5 resources        and      the      socio-economic          conditions 6 surrounding the proposed site.
7                  As    Jane    described        this    morning,      the 8 proposed site is currently an agricultural field. The 9 site has been previously disturbed due to decades of 10 agricultural activities and is currently zoned for 11 light industrial use.
12                  The proposed site does not contain any 13 surface        water  features,        threatened        or  endangered 14 species or historic or cultural resources.
15                  Next slide, please?
16                  For the proposed SHINE facility at the 17 Janesville site, the impacts to all resource areas, 18 except for traffic, would be small.
19                  A variety of project-specific activities 20 and site-specific conditions is the basis for the 21 small findings.
22                  For    example,        the      condition    of      the 23 previously        disturbed      site,      the      current    zoning 24 designation for light industrial use, the relatively 25 limited ground disturbance that would occur during NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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180 1 construction, operations and decommissioning, the use 2 of a public water system to obtain and discharge water 3 and adequate controls to ensure that radiological 4 exposures to workers and the public would be within 5 regulatory limits.
6                The impacts to traffic would range from 7 small to moderate based on the noticeable increase in 8 average daily traffic flow.                The addition of up to 9 1,000 trips per day from construction activities and 10 up to 580 trips a day from decommissioning activities 11 at the proposed SHINE site would result in increased 12 traffic volume near the facility.
13                During operations, a slight degradation of 14 service, also known as traffic delays, would occur at 15 an intersection near the facility during peak morning 16 hours of commuting.
17                Slide nine, please?
18                In addition to describing the existing 19 environment and assessing the potential impacts at the 20 proposed      site,    the    staff        assessed    potential 21 alternatives.
22                The need to compare the proposed site with 23 alternatives arises from one of the requirements in 24 Section 102 of NEPA.
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181 1 through its regulations in 10 CFR Part 51 and in its 2 Interim Staff Guidance augmenting NUREG-1537.
3                    The regulations and associated guidance 4 state that an EIS will include an analysis that 5 considers and weighs the environmental effects of the 6 proposed        action,      the    environmental        impacts        of 7 alternatives to the proposed action and alternatives 8 available          for    reducing        or      avoiding    adverse 9 environmental effects.
10                    As part of the EIS, the staff considered 11 the environmental impacts of the no-action alternative 12 or if the NRC denied the Construction Permit.
13                    The staff also examined potential impacts 14 at two alternative sites, Chippewa Falls and Stevens 15 Point.        Both of these sites are in Wisconsin.
16                    In    addition,          the      staff  examined 17 alternative        technologies        to    produce    molybdenum-99 18 which was a unique aspect of the SHINE review.
19                    Next slide, please?
20                    The alternative technologies analysis was 21 novel for the SHINE review because the staff developed 22 a methodology to narrow down the large number of 23 potential alternative technologies given that several 24 entities have proposed new technologies to produce 25 molybdenum-99.
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182 1                  The  proposed        new    technologies      are      at 2 various stages of development and several entities 3 currently produce molybdenum-99.
4                  The Council on Environmental Quality's 5 regulations implementing NEPA provides guidance when 6 a large number of potential alternatives exist.
7                  In such situations, NEPA only requires 8 that an agency analyze a reasonable number of examples 9 covering the full spectrum of alternatives in the EIS.
10                  To  begin      the      alternative      technology 11 evaluation, the staff initially considered the large 12 number of possible alternatives or various methods to 13 produce        molybdenum-99      such      as    currently  existing 14 technology and proposed technologies.
15                  The    staff        initially        narrowed        the 16 alternatives        technology        analysis      to  the    three 17 technologies other than SHINE that DOE's National 18 Nuclear Security Administration awarded cooperative 19 agreements for financial support.
20                  The        National            Nuclear      Security 21 Administration based its decision to award cooperative 22 agreements in part on an evaluation of technical 23 feasibility. Thus, these three technologies appear to 24 be reasonable.
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183 1 because no entity has proposed constructing a new 2 facility in the United States using technology that is 3 currently in use in other countries.
4                Additionally, the staff concluded that the 5 three entities awarded cooperative agreements covered 6 the spectrum of alternatives based on the general land 7 use requirements, power levels and other environmental 8 factors.
9                The three alternative technologies that 10 were selected included neutron capture technology, 11 aqueous homogeneous reactor technology and linear 12 accelerator based technology.
13                The      staff        further        narrowed        the 14 alternatives examined in depth by considering whether 15 sufficient environmental data existed to conduct a 16 meaningful alternatives analysis for each of the three 17 alternative technologies.
18                For  example,        the      staff  looked      for 19 publically available documents that describe the air 20 emissions,      estimated      dose      exposures,    water      use, 21 building      heights      and      footprints      and      other 22 environmental parameters to assess the environmental 23 impacts for each alternative technology.
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184 1 data to conduct a meaningful, in depth analysis for 2 the linear accelerator based technology.
3                  The staff did not identify any publicly 4 available documents with sufficient data to assess the 5 environmental impacts for a reactor using neutron 6 capture or an aqueous homogeneous reactor. Therefore, 7 these two technologies were eliminated from further 8 detailed analysis.
9                  Slide 11, please?
10                  In accordance with 10 CFR 51.105(a), the 11 staff        weighed  the    environmental,        economical      and 12 technical costs and benefits for the proposed action 13 alternative sites, the alternative technology and the 14 no-action alternative.
15                  The  main    costs    included    environmental 16 costs as well as the financial costs of construction, 17 operations and decommissioning.
18                  The main benefits included medical and 19 economic benefits.
20                  Next slide, please?
21                  The staff considered the environmental 22 costs of construction, operation and decommissioning.
23 For the proposed SHINE facility at the Janesville 24 site, the impacts to all resource areas, expect for 25 traffic, would be small. The impacts to traffic would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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185 1 be      small    to  moderate      because        of  the  noticeable 2 increase in average daily traffic flow.
3                    The      staff        determined        that        the 4 environmental impacts would be the same if the linear 5 accelerator based alternative was constructed and 6 operated on the Janesville site.
7                    The    environmental            impacts    at      both 8 alternative sites would be small for most resource 9 areas.        However, the impacts to noise would be small 10 to moderate at both Chippewa Falls and Stevens Point 11 in part because the nearest resident would be closer 12 than at the Janesville site and, therefore, the noise 13 would be more audible to the closest residents.
14                    The impacts to visual resources would be 15 small to moderate at the Stevens Point site because 16 the site and much of the surrounding area is forested.
17 In clearing onsite forests during construction would 18 increase        the  visibility        of      the    new  facility, 19 especially in contrast to the surrounding forested 20 area.
21                    Similar to the proposed Janesville site, 22 the impacts at both Chippewa Falls and Stevens Point 23 would be small to moderate for traffic.
24                    Therefore, the staff concluded that the 25 Janesville          site    would      be    the    environmentally NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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186 1 preferable alternative.
2                  Under    the    no-action        alternative,        no 3 changes would occur to the proposed SHINE site in 4 Janesville, Wisconsin.            The site would remain zoned 5 for light industrial use.              Therefore, impacts on all 6 resource areas would be small.
7                  However, the no-action alternative does 8 not meet the stated purpose and need to provide a 9 medical radioisotope production option that could help 10 meet the need for a domestic source of molybdenum-99.
11                  Slide 13, please?
12                  In terms of the benefits considered, the 13 proposed action would result in several societal, 14 medical and economical benefits.
15                  For example, the proposed action is in 16 accordance with U.S. policy to ensure a reliable 17 supply of medical radioisotopes while minimizing the 18 use of highly enriched uranium.
19                  In    addition,          the        production        of 20 molybdenum-99 would increase availability of medial 21 radioisotopes for U.S. public health needs.
22                  And, lastly, constructing and operating 23 the proposed SHINE facility would result in economic 24 benefits      such    as      tax    revenue        and  employment 25 opportunities        to    communities          located  near      the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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187 1 Janesville site.
2                Based on the small environmental impacts 3 associated with the proposed SHINE facility at the 4 Janesville site and the benefits to the U.S. medical 5 community, the efforts to support U.S. policy to 6 produce a domestic supply of molybdenum-99 using low 7 enriched uranium and the economic tax and employment 8 benefits associated with construction and operation of 9 the SHINE facility, the staff determined that the 10 benefits outweigh the small environmental costs.
11                Next slide, please?
12                In addition to NEPA, the NRC may adjust 13 other regulatory requirements within its EIS.                    For 14 example, the staff conducted a review of potential 15 impacts to the threatened and endangered species as 16 required by the Endangered Species Act.
17                Under this Act, the staff must consult 18 with the U.S. Fish and Wildlife Service to determine 19 whether threatened and endangered species could occur 20 on the proposed site and, if so, if the proposed 21 action would affect such species.
22                The proposed action would have no effect 23 on    threatened  and    endangered        species because      the 24 proposed site is primarily an agricultural field and 25 does not provide suitable habitat for any threatened NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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188 1 or endangered species.
2                  In a letter to the NRC, the U.S. Fish and 3 Wildlife      Service    stated      that    no    federally    listed 4 proposed or candidate species would be expected within 5 the project area and no further action is required by 6 the Endangered Species Act if SHINE constructs the 7 proposed facility on the Janesville site.
8                  Under Section 106 of the National Historic 9 Preservation Act, the staff is required to first 10 determine        whether      historic      properties      would        be 11 affected by the proposed action.
12                  If historic properties would be affected, 13 then the staff determines whether the effects would be 14 adverse.
15                  The proposed action would have no impact 16 on known historic and cultural resources because the 17 staff did not identify any historic and cultural 18 resources eligible for protection under the National 19 Historic Preservation Act.
20                  In July 2015, the Wisconsin Historical 21 Society concurred with the staff's determination that 22 no historic properties would be affected.
23                  Slide 15, please?
24                  On May 11, 2015, staff issued the draft 25 EIS for public comment.              During this comment period, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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189 1 the staff requested input from the public and other 2 federal, state and local agencies regarding the data 3 analyses and conclusion in the draft EIS.
4                  During this comment period, the NRC held 5 two public meetings in Janesville, Wisconsin.                            One 6 member of the public provided an oral statement at the 7 meetings.
8                  In addition, the staff received eight 9 written letters from members of the public, Wisconsin 10 Department        of    Natural        Resources,        the      U.S.
11 Environmental        Protection        Agency,        Peoria  Tribe      of 12 Indians of Oklahoma and from SHINE.
13                  In-scope comments addressed a variety of 14 environmental issues including the potential impacts 15 from        accidents    due    to    aircrafts,        storage        of 16 radioactive        waste,      greenhouse        gases    and  climate 17 change, potential contamination to nearby agricultural 18 lands and alternative sites and technologies.
19                  The staff responded to all comments in the 20 final EIS which was published on October 16, 2015.
21 The staff provides the final EIS based on the in-scope 22 comments and based on newly available information 23 since the publication of the draft EIS.
24                  Next slide, please?
25                  In accordance with 10 CFR 51.105(a), the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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190 1 staff        weighed  the    environmental,          economical      and 2 technical costs and benefits for the proposed action, 3 alternative sites and the alternative technology and 4 the no-action alternative.
5                  Based on the small environmental impacts 6 associated with the proposed SHINE facility at the 7 Janesville site and the societal, medical and economic 8 benefits associated with the proposed SHINE facility, 9 the staff determined that the benefits outweigh the 10 small environmental costs.
11                  Therefore,        in    the        EIS,  the      staff 12 recommends the issuance of the Construction Permit.
13                  Slide 17, please?
14                  The issuance of a Construction Permit is 15 a separate licensing action from the issuance of an 16 Operating License.          If the NRC issues a Construction 17 Permit, 10 CFR part 50 requires that SHINE submit a 18 separate Application for an Operating License.
19                  If SHINE were to submit an Application for 20 an Operating License for a production or utilization 21 facility, the staff would prepare a supplement to the 22 EIS in accordance with 10 CFR 51.95(b).
23                  The supplement to the final EIS would 24 update the environmental review by discussing issues 25 or topics not included in the final EIS and any new NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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191 1 and        significant    information            regarding    matters 2 discussed in the final EIS.
3                  The staff would follow the environmental 4 review process outlined in 10 CFR Part 15 in preparing 5 the      supplement  to      the    EIS,      including    scoping, 6 requesting      comments    on    the    EIS      and  updating      the 7 supplement      to  the    EIS    based      on    public  comments 8 received.
9                  This concludes the staff's remarks in the 10 Environmental Panel.            We are prepared to answer any 11 questions you may have.
12                  CHAIRMAN BURNS:        Okay.        And, what I might 13 ask you to do is do a little bit of shuffle again so 14 we can all see.
15                  And, I'll start off with questions.
16                  I found it interesting, Mr. Wrona, that 17 there was a -- your testimony discussed the question 18 of whether or not an Environmental Impact Statement 19 would have been prepared for this site.
20                  Was there really a serious question that 21 there would not have been an EIS for a project of this 22 kind?
23                  For  example,        if  this      were  a  research 24 reactor, would that have normally required an EIS?
25                  MR. WRONA: The issuance of a Construction NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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192 1 Permit for a research reactor would not, again, be in 2 10 CFR Part 51.20 as required to have an EIS issued.
3                  We look at these on a case by case basis.
4 So, it would depend on what the proposed action is and 5 what is going on at the site where they're proposing.
6                  CHAIRMAN BURNS:          Okay.      So, in sum, you 7 would say that the two major factors or the major 8 factors that led the staff to conclude that an EIS was 9 an appropriate means of addressing our NEPA obligation 10 were what?
11                  MR. WRONA:      It was, for the SHINE case, 12 the unique first-of-a-kind application was one of the 13 things and the main thing that led us to develop an 14 EIS for SHINE.        That was pretty much the main issue 15 for development of an EIS.
16                  CHAIRMAN BURNS:        Okay, all right, thanks.
17                  I think, Ms. Moser, you, in discussing the 18 alternative technologies, one thing I think I heard 19 you say is that the staff excluded from consideration 20 as alternative technologies, technologies used outside 21 of the United States.
22                  I'm trying to understand that because what 23 that      includes,  is    that    basically        using what        is 24 currently the source which an aging research reactors?
25                  MS. MOSER:        Correct.        We excluded that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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193 1 from further detailed studies.
2                  CHAIRMAN BURNS: Okay, so there isn't some 3 other newer technology that's being considered at this 4 point?        I'm just trying to understand the scope of 5 what -- it was interesting how you said that.
6                  So, basically, what it was, you were not 7 considering production in a research reactor such as 8 is currently conducted is what you're saying?
9                  MS. MOSER:        Correct, outside of the --
10 yes, that is currently occurring outside of the United 11 States and we eliminated that from further study 12 within our alternative technology analysis.
13                  CHAIRMAN BURNS:          Okay.
14                  One of the things you also just spoke to 15 in terms of describing the comments was comments that 16 were      within  scope.      I    presume      were some    of    the 17 comments what you considered out of scope and what 18 would they be?        Where I don't like any of this kind of 19 technology, is that what I should conclude from that?
20                  MS. MOSER:        Yes,      we  received    a    few 21 comments that expressed opposition to the facility 22 which we considered out of scope for the environmental 23 impact statement.
24                  Other out of scope comments included --
25                  CHAIRMAN BURNS: But, why were they out of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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194 1 scope?        They can -- it's fine to be against the 2 facility but you have to have some -- I presume there 3 has to be some content there that is relevant to the 4 considerations we take into account?
5                  MS. MOSER:        Correct.        If it would have 6 described environmental concerns that should have been 7 -- that were within the scope of what we analyzed in 8 the Environmental Impact Statement such as concerns 9 from potential accidents, then that we would have 10 considered        within    scope    and    that      we  would      have 11 analyzed within the EIS.
12                  CHAIRMAN BURNS:          Okay.
13                  You said that there were no historic or 14 archaeological        or      the    impact        on    historic        or 15 archaeological resources wasn't an identified.
16                  You did receive one, maybe two comments 17 from Tribal organizations.                What were the nature of 18 those comments?
19                  MS. MOSER:        Both    of    the  Tribes      that 20 submitted comments to us expressed that they wanted to 21 know additional information if any studies occurred or 22 if there was an inadvertent find of something like 23 human remains, they wanted to be notified.
24                  CHAIRMAN BURNS:          Okay.      So, they want to 25 be      informed    if    further      studies        were    done        or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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195 1 significant remains of some kind?
2                  MS. MOSER:      Well, to clarify, one of them 3 asked for a copy of the study that was conducted 4 onsite.
5                  CHAIRMAN BURNS:          Okay, okay.      All right, 6 thanks.
7                  I wanted -- the last question I have, I 8 want to understand in terms of the assessment of 9 alternative sites and the Chippewa Falls site and the 10 Stevens        Lake  or      Stevens        Point,      thank      you, 11 Commissioner, Stevens Point site.
12                  You  described        and    I    saw also  in    the 13 Applicant's      presentation        that      the    differences      in 14 impacts were moderate or described as moderate with 15 respect to the Stevens Point and Chippewa site.
16                  And, I think you describe it that that 17 became moderate because of noise consideration.                          Is 18 that the only thing that reached your assessment that 19 it would become a moderate impact?
20                  MS. MOSER:          At Stevens Point, it was 21 noise, visual resources --
22                  CHAIRMAN BURNS: Oh, visual, that's right.
23                  MS. MOSER:      -- and traffic.
24                  CHAIRMAN BURNS:          Okay.
25                  MS. MOSER:      And, at Chippewa Falls it was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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196 1 noise and traffic.
2                  CHAIRMAN BURNS:            But, the traffic, it 3 sounded like the traffic at all three sites --
4                  MS. MOSER:      Exactly.
5                  CHAIRMAN BURNS:          -- is more or less the 6 same?
7                  MS. MOSER:      Yes, at all three sites.
8                  CHAIRMAN BURNS:          What tips over into a 9 moderate        impact  in    terms    of    noise?    Is  it    the 10 population near to the -- you said -- I know you 11 described that whoever has their house nearest to that 12 site is closer than at the Janesville site or the 13 proposed site.
14                  Is it also a factor of population in those 15 areas?
16                  MS. MOSER:      Two main factors drove that.
17 One was, as you mentioned, how close the nearest 18 resident is because that would affect how audible the 19 noise is.
20                  The second factor is what's the change in 21 noise?        So, the amount of noise would be similar 22 across all three sites, but because at the alternative 23 sites, the background noise is less.                  The delta, the 24 change in noise would be more noticeable.
25                  CHAIRMAN      BURNS:        And,  is  this    noise NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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197 1 primarily during the construction period or demolition 2 period or is it normal operations?
3                    MS. MOSER: Primarily during construction 4 and decommissioning.
5                    CHAIRMAN BURNS:          Okay.      All right, thank 6 you very much.
7                    Commissioner Svinicki?
8                    COMMISSIONER SVINICKI: May I testify, Mr.
9 Chairman, that both Chippewa Falls and Stevens Point 10 and Janesville are very lovely locations.                      And, just 11 as someone who will be traveling to Wisconsin next 12 week,        I  would  commend      to    you    that  the  State      of 13 Wisconsin has a really impressive state park and trail 14 system.
15                    And, to Commissioner Ostendorff, for those 16 of us into cycling, distance cycling, Wisconsin has 17 some of the earliest rails to trails conversions that 18 are paved and really extensive.                        Some of them go 19 through old railroad tunnels.
20                    Now,  I    did    note    that      the  Applicant's 21 photos        of  site  characterizations              showed  everyone 22 bundled up and shivering in the cold.                        The staff's 23 visit in July, those were lovely photos that tell you 24 the beauty, the natural beauty, of the State of 25 Wisconsin and the Janesville area.
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198 1                  This is the environmental panel, so this 2 is all germane to our discussion here.
3                  I actually came at -- I do thank everyone 4 for their presentations and for all of their hard work 5 that is underlying these evaluations that have been 6 done.
7                  To the staff, interestingly, I came at 8 your elective choice to do an EIS from the complete 9 opposite perspective of a question that the Chairman 10 asked you.      An EIS was not strictly required here and 11 given that, one can always elect to do more because 12 there's never anyone who's going to prohibit you from 13 doing the EIS versus the environmental assessment.
14                  How does the staff establish a system of 15 discriminating elements that you don't always default 16 to doing something, doing the EIS, the more involved 17 process?      It does increase the resource investment 18 and, you know, has the potential to increase the time 19 duration of the review process as a whole, depending 20 on how the safety review is proceeding in parallel.
21                  You know, how does the -- what would be 22 backstops      when    the    staff      would      say  yes,        an 23 environmental assessment is indeed the appropriate 24 thing to do if you have the elective choice?
25                  MS. MARSHALL:          One      of our  points      of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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199 1 consideration was how well the staff understood the 2 impacts before performing the assessment.                        Because 3 this      was  a  first-of-a-kind          application        for    this 4 technology, the staff was not certain with what the 5 outcome of the assessment would be.
6                  If  we    had    performed          an  environmental 7 assessment and produced a finding, we would have had 8 to do the Environmental Impact Statement following the 9 assessment.        So, that would have increased the time 10 line.
11                  We also considered what actions we would 12 take which included public involvement even in and 13 environmental assessment and the time lines for either 14 an EA or an EIS came out very similar.
15                  COMMISSIONER        SVINICKI:            That    is      an 16 important point and I appreciate you mentioning it 17 that      an  EA  can    lead    to    an    EIS,    so  it  is    not 18 necessarily an either or.                You may end up doing the 19 Environmental Impact Statement even if you begin with 20 the environmental assessment process.
21                  So, thank you for the answer on that.
22                  Again, the Applicant has discussed the 23 fact that they have a policy of transparency and 24 outreach.        They touched on that in the overview and 25 they touched on it here in this panel with their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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200 1 testimony.
2                  I  would    ask    the  Applicant,    could      you 3 elaborate on your separate and distinct outreach and 4 just creating awareness of the proposed facility and 5 what it would do separate from the staff's outreach 6 under -- to Trial entities under Tribal outreach for 7 the EIS?      Could you discuss any specific outreach you 8 did to the Potawatomi Tribe or to the Ho-chunk Nation 9 and what form that took?              Did you make overtures of 10 your own as the Applicant?
11                  MS. PITAS:      We did.        So, we sent letters 12 to all of the 13 Tribes that I mentioned in my 13 presentation.        And then, when we failed to receive 14 responses from the majority of them, actually made 15 phone calls and, in most cases, left voice mail 16 messages with most of them.
17                  COMMISSIONER SVINICKI:              Okay.
18                  MS. PITAS:      And maybe even all of them.
19 I think probably all of them.
20                  COMMISSIONER SVINICKI:              Okay, thank you.
21                  And, I'll just close by just saying, Jane, 22 you should go to Janesville.              Did you go on the trip 23 to Janesville?        If there was a Christinesville, I 24 would definitely go.
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201 1 during the --
2                COMMISSIONER SVINICKI:              Oh, and he should 3 go to Stevens Point.
4                CHAIRMAN      BURNS:              They    spell        it 5 differently.
6                MS. MARSHALL:        But no, I do hope to go in 7 the future.
8                COMMISSIONER SVINICKI:              Okay. All right, 9 thank you.
10                Thank you, Mr. Chairman.
11                CHAIRMAN BURNS: Thank you, Commissioner.
12                Commissioner Ostendorff?
13                COMMISSIONER        OSTENDORFF:          Well,    since 14 we're still on the travelogue, I think Commissioner 15 Svinicki and I share a common experience every --
16 twice a day, every day, as we drive from Northern 17 Virginia into the NCR via the American Legion Bridge 18 listening to the WTOP Traffic on the Eights or looking 19 at the ways display on our iPhones, is it a fair 20 statement that the traffic in Janesville is less than 21 in this area?
22                COMMISSIONER        SVINICKI:          It  is,    but    I 23 appreciate    that    the    staff      has      looked    at      not 24 replicating the Washington traffic in Janesville, 25 which I don't think any Janesvillian would appreciate.
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202 1                  COMMISSIONER OSTENDORFF: Good, thank you.
2                  I  thought      that      was      the  case,    but      I 3 appreciate your clarification.
4                  So, let me turn to the Applicant and I'm 5 going to ask Katrina question on outreach as well.
6 And, it really gets into the unique nature of this 7 facility.
8                  Certainly, Wisconsin's had experience the 9 Kewaunee Nuclear Power Plant, with Point Beach Regular 10 Commercial Power Reactors.                But here, we're talking 11 about, you know, deuterium bombarding tritium and 12 generating 14 MeV and, you know, neutrons and the 13 whole nuclear physics chain.                And, doing source term 14 is very different from commercial power reactors.
15                  What    can    you      tell      us  about        the 16 understanding from your perspective with the SHINE 17 organization of the local community's appreciation for 18 what      this  is  and    what    it's      not    compared    to    a 19 commercial power reactor?                Does that make sense to 20 you?
21                  MS. PITAS:          It  does.        And,    it's      a 22 difficult question to answer because I think there is 23 a wide range of understanding within the community.
24 I    think    the  community      especially        appreciates      the 25 global impact of the product, medical isotopes, in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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203 1 particular.
2                    We've done our best to develop materials 3 that      are  simple    enough      that      they    increase      the 4 understanding        of  someone      without      an  expert    level 5 understanding of nuclear processes and work hard to 6 bring        those  to    our    outreach        meetings    with      the 7 community.        So, we have posters, brochures.
8                    In  terms    of    understanding        maybe      the 9 hazards of the facility --
10                    COMMISSIONER OSTENDORFF: Well, just like, 11 you know, I think on your slides and the overview 12 panel earlier today talks about the source term being 13 a factor of hundreds less than for existing isotope 14 production reactors elsewhere.
15                    So,  just,      you    know,      looking  at      the 16 relative scale of the radiological source, do people 17 understand that?
18                    MS. PITAS:      Yes, so I think so.          It's one 19 of the key talking points that we use with the public 20 is in comparison to current production methods, the 21 amount of radioactivity produced per useful medical 22 isotope is hundreds of times less than -- yes, people 23 see that as a major benefit and a step forward for 24 global medical isotope production.
25                    COMMISSIONER OSTENDORFF:              Okay. Let me NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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204 1 stay with the Applicant for several questions.
2                You  know,      our    staff        talked  about      the 3 complementary    environmental          impact      statement    work 4 between the NRC staff and the Department of Energy.
5 As far as the SHINE organization's concerned, did you 6 see a fairly consistent approach or did you see 7 evidence that different approaches between NRC type 8 questions and Department of Energy questions or how 9 would you characterize that experience?
10                MS. PITAS:      I'm not sure I know.            I'm not 11 very -- yes, go ahead, we'll call Greg Piefer to the 12 stand.
13                MR. PIEFER:      So, Greg Piefer, still under 14 oath.
15                I think, you know, DOE largely let the NRC 16 process drive the show here and I think the NRC 17 process was very thorough.            I assume there were some 18 negotiations behind the scenes in terms of making sure 19 DOE specific assessments were included in the NRC 20 process.
21                But, you know, I think it worked out 22 pretty well in this case and I think the NRC EIS time 23 line was within sort of the Construction Permit Safety 24 Review time line and so, it didn't new time.
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205 1 knows what would have happened if they had chosen to 2 do an EIS. And so, I think, you know, ultimately, it 3 worked out well in this case.
4                COMMISSIONER OSTENDORFF: Okay, thank you.
5                My final comments relates to NRC staff and 6 goes to Michelle.        Your comments and the Chairman's 7 comments on the alternative technologies, I appreciate 8 it.
9                It seems like the staff has exercised a 10 very commonsense approach.            If there's not something 11 there to evaluate then we shouldn't evaluate it.                    And 12 so, it looks like you all made a judgment call that 13 there was not sufficient evidence to look at some of 14 these other alternative technologies, so I just wanted 15 to comment favorably on the approach being taken.
16                Thank you.      Thank you all.
17                CHAIRMAN BURNS: Thank you, Commissioner.
18                Commissioner Baran?
19                COMMISSIONER BARAN:            Thanks.
20                Michelle,        the      staff's      answer        to 21 pre-hearing question 53 stated that it took climate 22 change into account when examining impacts to the 23 affected resources.          The staff explained that it 24 looked at annual mean temperature increases and the 25 increase in the frequency, duration and intensity of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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206 1 droughts.
2                  I really appreciate that you did that, 3 that the staff did that analysis.                    I think we should 4 be    factoring    in  climate      change        impacts  into      our 5 environmental reviews more often.                    So, I commend you 6 all for doing that.
7                  Can you tell us a little bit more about 8 what you did and how you did it?
9                  MS. MOSER:      Certainly.          In Section 4.2 of 10 the EIS is where we analyzed emissions that could 11 potentially contribute to climate change.                        And, in 12 Section        4.13,  we    conducted        a    cumulative    impacts 13 analysis where we looked at what the overlapping 14 impacts        could    be    from    climate        change  on      the 15 environmental resources that could also be affected by 16 the proposed SHINE facility.
17                  COMMISSIONER BARAN:            Thank you.
18                  I also wanted to follow up on Commissioner 19 Svinicki's question about greater than Class C waste 20 that she asked earlier.
21                  In response to that question, SHINE, you 22 noted        that  under    the    American        Medical  Isotope 23 Production Act, DOE would take title to and dispose of 24 any radioactive waste without a disposal path.
25                  My  question        is,      have    you  had      any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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207 1 discussions with DOE about how this program would 2 work?          Are  they    committing          to  physically    take 3 possession of the waste or make arrangements to store 4 it or dispose of it at another location within a 5 certain time frame?
6                    MS. PITAS: We'd like to call Van Bynum to 7 the stand to talk about that.
8                    CHAIRMAN BURNS:          And, again, state your 9 name and confirm that you've been put under oath.
10                    MR. BYNUM:      My name's Van Bynum and I did 11 take the oath this morning.
12                    COMMISSIONER BURNS:            Okay.
13                    MR. BYNUM:          We've      had  a  number      of 14 discussions with DOE both at NNSA side and the EM side 15 for the lease and take back program. They've provided 16 us a draft contract template for the take back and 17 we're expecting a revised draft coming in January when 18 the program's supposed to be stood up.                      So, there's 19 been extensive discussions with them.
20                    COMMISSIONER BARAN:            Okay. And is this a 21 matter of them taking formal title to the waste or are 22 they physically going to take it off your hands 23 somehow?
24                    MR. BYNUM:        Physically take it off our 25 hands.
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208 1                COMMISSIONER BARAN:            Okay. So, when you 2 all kind of are looking at how long you would expect 3 to      potentially  need    to    store      it    onsite,    you're 4 factoring in that DOE is committing to actually take 5 it offsite for you?
6                MR. BYNUM:      Yes.
7                COMMISSIONER BARAN:              Yes?    And it's a 8 relatively short time frame?
9                MR. BYNUM:      We hope.
10                COMMISSIONER BARAN:                You hope?        Okay.
11 Fair enough.
12                That's all I have.            Thank you.
13                MR. BYNUM:      Thank you.
14                COMMISSIONER        BARAN:          Thank  you,      Mr.
15 Chairman.
16                CHAIRMAN BURNS:          Well, thanks --
17                COMMISSIONER BARAN:            I should just note, 18 I don't have any tourism related questions.                    At some 19 point on this panel, I'm like, wow, when did I join 20 the Wisconsin Tourism Commission?                  But, I'll just --
21                COMMISSIONER SVINICKI:              You should be so 22 lucky.
23                COMMISSIONER        BARAN:            I'm  from      the 24 Chicagoland area.        Wisconsin's lovely.
25                COMMISSIONER SVINICKI:                So, you're from NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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209 1 Chicagoland and you've never vacationed in Wisconsin?
2 You are the only person from Illinois that on a nice 3 weekend is not up there clogging all the highways into 4 Wisconsin.
5                    COMMISSIONER BARAN: I did not say that --
6                    COMMISSIONER SVINICKI: And owning all the 7 prime real estate.
8                    COMMISSIONER BARAN:                I don't have any 9 prime real estate in Wisconsin.                      I have vacationed 10 there,        I just  wasn't,      you    know,      like advocating 11 vacationing there in the same way.
12                    CHAIRMAN BURNS:          And, I engaged in some 13 other -- I told Commissioner Svinicki, I actually 14 represented staff in proceedings in Wisconsin on the 15 La Crosse reactor which is --
16                    COMMISSIONER SVINICKI:              And, I do recall 17 you said it was beautiful there.
18                    CHAIRMAN BURNS:            And, I was beautiful, 19 it's a gorgeous area.
20                    So, any that, we'll have travel brochures 21 as you exit today.
22                    But, I want to thank the environmental 23 panel.
24                    We're going to take about a five, ten 25 minute break here.            Try to be back in about five or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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210 1 six      minutes.      And      then    we'll      have the  closing 2 presentations from both the Applicant and from the 3 staff.
4                    And, for both the Applicant and the staff, 5 I would say if there is any clarification, before your 6 closing statement, if there's any clarification you 7 want to make to the presentations, that would be the 8 time.          We can time to do it that you feel you're 9 prepared to do today.
10                    And, with that, we'll, again, adjourn for 11 about ten minutes.
12                    (Whereupon, the above-entitled matter went 13 off the record at 3:00 p.m.)
14                    CHAIRMAN BURNS:            Well, good afternoon 15 again. This is the closing portion of the hearing and 16 we'll start first with the Applicant and I think, Mr.
17 Piefer, you're going to do -- is there any other 18 supplement that you all wanted to do to your testimony 19 or --
20                    MR. PIEFER:        No, we have no additions --
21                    CHAIRMAN BURNS:          Okay.
22                    MR. PIEFER:        -- or changes.
23                    CHAIRMAN BURNS:          Then please proceed.
24                    MR. PIEFER:        Yes. So I have very little 25 to say at this point.            I just wanted to thank you guys NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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211 1 again for your time, your consideration in this very 2 important matter.
3                    I  did      want    to      offer    thanks        and 4 commendation to the staff for very transparent and 5 straightforward            communications              throughout        this 6 process. I think our team has been very impressed and 7 wanted to let you guys know that.                    So thank you again 8 for      your    time  today      and    really      appreciate        the 9 consideration.
10                    CHAIRMAN BURNS:          Thank you.        Mr. Dean, 11 you're        on for  the    staff,    but    there    may  be    some 12 supplement that the staff would like to make at this 13 point?
14                    MR. DEAN: Yes, thank you, Chairman. Yes, 15 this morning we had I think a few open questions, open 16 issues where we didn't either cleanly answer the 17 question or maybe we left a question open, so we 18 thought it would be beneficial if Steve Lynch could 19 provide you responses to the five particular areas 20 where          we  think      we    needed        to    provide        more 21 clarification.          So if you don't mind, I'll have 22 Steve --
23                    CHAIRMAN BURNS:        Okay.      Mr. Lynch, please 24 proceed.
25                    MR. LYNCH:      Yes, I'll run through these NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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212 1 very quickly.      The first was with respect to the size 2 of aircraft that were analyzed for our review.                      Just 3 wanted to clarify that the staff examined -- there 4 were three main categories of aircraft that were 5 broadly military, small and large.                    And the analysis 6 was probabilistic on this looking at both those types 7 of aircraft that would land at the airport and those 8 that would be passing overhead in the corridors.                        So 9 for this analysis no matter whether the aircraft was 10 landing at the SHINE site, or at the airport across 11 the street, or overhead, if the probability was less 12 than the threshold, it was excluded from examination.
13 The only types of aircraft were two small aircraft, 14 the Challenger 605 and the Hawker 400, that SHINE 15 analyzed as being above the threshold and the facility 16 has been designed to withstand those aircraft impacts.
17                  The second issue we had identified was the 18 natural gas pipelines. To clarify, yes, the staff did 19 look at natural gas pipelines near the SHINE facility 20 and at the SHINE facility.                These are provided in 21 figures both in the staff's SER and SHINE's PSAR in 22 chapter 2.      There's also a table in SHINE's PSAR in 23 chapter 2 that gives distances and sizes of the 24 natural gas pipelines surrounding the facility. While 25 the        sizes  of    the    pipelines          are  proprietary NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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213 1 information, the distances are given.
2                  The next issue I had, I wanted to clarify 3 some        statements    that    we    made        with  respect        to 4 differentiating between the irradiation facility and 5 the      production    facility.          In    our  Interim    Staff 6 Guidance we had initially assumed that the irradiation 7 facility or an irradiation-like facility would be 8 dependent functionally on the production facility in 9 order to perform and make medical radioisotopes.                          So 10 that is why in our guidance we'd initially thought 11 that a single production facility license could be 12 issued for the entire facility.
13                  After reviewing SHINE's application we 14 came      to  the  understanding          that      the  irradiation 15 facility and radioisotope production facility could 16 operate separately and independently, meaning SHINE 17 can irradiate as much uranium as they want at the 18 irradiation facility without impacting the function of 19 the production facility.              They don't even need to be 20 in the same building.              They could be in different 21 states.        So because of that we understood that the 22 irradiation facility is licensed as irradiation units 23 and the production facility is separately licensed as 24 the production facility.
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214 1 distinguishing between commitments and conditions.
2 Items that are identified in SHINE's Corrective Action 3 Program that they provided to the staff and that the 4 staff determined could be reasonably left for later 5 consideration in the final safety analysis report, 6 those represent the regulatory commitments that SHINE 7 has made. The conditions on the other hand are issues 8 that the staff would like more information on during 9 construction.          And we'd like to emphasize that the 10 conditions, unlike the commitments, cannot be changed 11 without prior NRC approval.
12                    And then the final item that I would like 13 to    provide      clarification        on  were    the  differences 14 between the soluble uranium intake concentrations of 15 10 milligrams per week for occupational limits and 30 16 milligrams        for  accident        conditions.          So    that's 17 essentially        it.      We  think      these      two  limits      are 18 compatible and that for an occupational worker if 19 you're        receiving    10  milligrams          per  week    per      the 20 regulations you could receive up to 520 milligrams of 21 soluble        uranium  and    still      be    in  line  with      the 22 regulations each year.
23                    The 30-milligram intake in contrast to 24 that is assuming an acute exposure from a highly 25 unlikely accident, meaning this is an event that has NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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215 1 a 10 to the minus 5 likelihood of occurring over a 2 24-hour period.          So we think the differences between 3 routine occupational exposure versus an acute accident 4 exposure explained the differences and that they are 5 consistent with one another.
6                    And those are all the comments that I have 7 to make.
8                    CHAIRMAN BURNS:        Okay.      Mr. Dean, proceed 9 with your --
10                    MR. DEAN: Thank you. And in light of the 11 previous discussion, I have been to Williamsburg.                            I 12 don't know if that counts --
13                    (Laughter) 14                    MR. DEAN:      Kristinesville and Barantown.
15 I don't know.
16                    The    staff's        review        of  the      SHINE 17 construction permit application supports the national 18 policy objectives of establishing a domestic supply of 19 molybdenum-99. The SHINE review presented a number of 20 unique technical and licensing considerations for the 21 staff.        The timely completion of this review required 22 the expertise, cooperation and dedication of staff 23 throughout        the  agency.          The    thoroughness      of    the 24 staff's        evaluation    is    reflected        by  the  Advisory 25 Committee on Reactor Safeguards' recommendation to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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216 1 issue the construction permit.
2                  I'd particularly like to commend our staff 3 given the fact that this was a first of a kind, unique 4 review and the fact that they were able to accomplish 5 it in a short time frame, within two years.                        And I 6 particularly want to commend the individual on my 7 right, Mr. Lynch, who has been the project manager for 8 the SHINE. He has just done a tremendous job in terms 9 of      overseeing    that.        So    I    wanted    to  take      the 10 opportunity to do that at this time.
11                  The staff evaluated SHINE's preliminary 12 design to ensure sufficiency of information to provide 13 reasonable      assurance      that    the      final  design    will 14 conform to the design-bases. The staff considered the 15 preliminary analysis and evaluation of the design and 16 performance of structures, systems and components of 17 the SHINE facility with the objective of assessing the 18 risk      to  public  health      and    safety    resulting    from 19 operation of the facility.
20                  Structures, systems and components were 21 evaluated to ensure that they would adequately provide 22 for the prevention of accidents and the mitigation of 23 consequences        of  accidents.            And    the  staff    also 24 considered the potential environmental impact of the 25 facility in accordance with the National Environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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217 1 Policy Act.
2                    The objective of the staff's evaluation 3 was to assess the sufficiency of information contained 4 in the PSAR for the issuance of a construction permit.
5 As such, the staff's evaluation of the preliminary 6 design and analysis of the SHINE facility does not 7 constitute        approval    of    the    safety    of  any    design 8 features or specifications.                  Such approval will be 9 made following the evaluation of the final design of 10 the facility as described in the FSAR as part of 11 SHINE's operating license application.                    An in-depth 12 evaluation of the SHINE design will be performed 13 following the staff's receipt of SHINE's FSAR.
14                    Based    on    the    findings      of  the  staff's 15 review as documented in the Safety Evaluation Report 16 and the final EIS, Environmental Impact Statement, and 17 in accordance with 10 CFR Parts 50 and 51, the staff 18 concludes that there is sufficient information for the 19 Commission to issue the subject construction permit to 20 SHINE.        And that concludes my closing remarks.
21                    CHAIRMAN BURNS:            Thank you.      And for 22 closing, any closing questions or remarks, we'll start 23 with Commissioner Svinicki.
24                    COMMISSIONER SVINICKI: Well, again I want 25 to thank everyone for their presentations. And, Bill, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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218 1 I appreciate that you've been to Williamsburg.                      And 2 all I have to say, at the risk of sounding like John 3 Belushi in Animal House, if there's a bear in town, I 4 got one thing to say:        Road trip.          I think we should 5 move immediately.        The Commission make a road trip 6 there.
7                On a more serious note, I think we don't 8 get to this stage in the licensing process or the 9 issuance of a construction permit without tremendous 10 dedication to the task by both the Applicant and the 11 staff, and tremendous professionalism I think was 12 displayed, not only today, but was evident in the 13 description in the engagements both with external 14 parties and with each other that we've heard about in 15 the answers to the questions throughout the mandatory 16 hearing here today.
17                Again, I'd just note for anyone listening 18 unfamiliar with this process, this hearing and the Q 19 & A conducted is not the totality of the record.
20 There is tremendous analytical record that backs up 21 all of the responses that we heard today.                      It is 22 voluminous. And then there were prehearing materials 23 and testimony that was provided to all members of the 24 Commission, which we began with a resumption today 25 that the Commission already knew that, but that was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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219 1 hundreds of pages I think in and of itself.
2                    So  I  thank      again,      especially    looking 3 inwardly        to  the    NRC,    all    of    the    NRC  staff      that 4 contributed.        And that's everyone, both the technical 5 staff, the legal staff, but all those in support roles 6 that make it possible to conduct a hearing like this.
7 And I think that the Commission is well-served to make 8 a very efficient deliberation and hopefully a timely 9 decision on this matter.                Thank you, Mr. Chairman.
10                    CHAIRMAN BURNS:        Thank you.        Commissioner 11 Ostendorff?
12                    COMMISSIONER OSTENDORFF:                Thank you.        I 13 have no questions.            My comments are very similar to 14 Commissioner          Svinicki's          for        SHINE    and        the 15 organization.          I appreciate the professionalism and 16 the attention to detail that you've obviously provided 17 in your application.
18                    To the NRC staff, I am pleased to be part 19 of    an    organization      working      at      looking  at    a    new 20 technology and looking at things that are different 21 from what we've done in the past.                  And so I think that 22 aspect that's been highlighted by many at this table 23 today is very significant.                And being able to take a 24 good look at what our regulations require, what's the 25 spirit and the intent and how to apply those to areas NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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220 1 where perhaps all the Is may not be dotted and all the 2 Ts may be crossed, but in a way to execute our 3 responsibilities in a common sense approach when there 4 may not be complete word-for-word coverage that's 5 identical to what we've dealt with in the past.                          So 6 that's I think a significant accomplishment.
7                  And I do appreciate the work of all the 8 staff, as Commissioner Svinicki noted, across the 9 entire agency.        Well done.
10                  CHAIRMAN BURNS:          Thank you.      Commission 11 Baran?
12                  COMMISSIONER BARAN:            Well, just briefly I 13 want to join my colleagues in thanking the NRC staff 14 and SHINE for all of your hard work throughout the 15 review        of this  application.              We  appreciate      the 16 significant amount of preparation that goes into one 17 of these mandatory hearings, so thank you for all that 18 work.
19                  I think today's hearing's been valuable.
20 It's a valuable part of the process and I thank 21 everyone for their efforts.
22                  CHAIRMAN BURNS:            Thank you.      And I'll 23 conclude by echoing the comments of my colleagues. As 24 well I appreciate the effort, both the Applicant 25 SHINE, as well as the staff have put into it.                    And as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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221 1 Commissioner Svinicki said, we're really just doing a 2 sampling here today.          There's a much deeper record on 3 which the decision making will be based as we consider 4 whether or not to allow issuance of a construction 5 permit under the Atomic Energy Act for this facility.
6 But it reflects a lot of hard work and thoughtful work 7 by both the Applicant and the staff.
8                  I also want to conclude by thanking behind 9 the scenes support we get as well from the Commission 10 Appellate Adjudication and the Office of the Secretary 11 that assure the smooth flow of these proceedings.
12                  And with that, I will mention two other 13 things, and hopefully not be considered Scrooge in 14 announcing them.        And that is that you may expect --
15 the Applicant and staff may expect the Secretary to 16 issue an order with post-hearing questions by about 17 December 22nd.        And the deadline for the responses 18 will likely be December 30th. So you can do it before 19 the new year.
20                  And  then      also    obviously    we've    had      a 21 transcript made of the proceedings here today and the 22 transcript will be provided by the Secretary with an 23 order requesting proposed corrections.                    That order 24 will      probably  issue      around    December    21st  with      a 25 one-week      deadline    for    transcript      corrections        on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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222 1 December 28th.
2                Part    of    the    reason        for that  is    the 3 Commission I think in its -- in my experience, both as 4 general counsel and now returning to the agency in the 5 last year with my colleagues presiding over these 6 proceedings is the Commission is dedicated to making 7 decisions in a timely fashion in these proceedings.
8 And in saying that, I do expect us to issue a final 9 decision promptly with due regard to the complexity of 10 the issues before us.
11                Again, thank you, everyone.              And we are 12 adjourned.
13                (Whereupon, the above-entitled matter went 14 off the record at 3:23 p.m.)
15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of                                  )
                                                  )
SHINE Medical Technologies, Inc.                  )  Docket No. 50-608-CP
                                                  )
(Mandatory Hearing)                        )
CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing ORDER (Setting Deadline for Proposed Transcript Corrections) have been served upon the following persons by the Electronic Information Exchange.
U.S. Nuclear Regulatory Commission                  U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication        Office of the Secretary of the Commission Mail Stop: O-7H4                                    Mail Stop: O-16C1 Washington, DC 20555-0001                          Washington, DC 20555-0001 E-mail: ocaamail@nrc.gov                            Hearing Docket E-mail: hearingdocket@nrc.gov Morgan, Lewis & Bockius, LLP                        U.S. Nuclear Regulatory Commission 1111 Pennsylvania Ave., NW                          Office of the General Counsel Washington, DC 20004                                Mail Stop - O-15 D21 Counsel for the Applicant                          Washington, DC 20555-0001 Paul M. Bessette, Esq.                              Mitzi A. Young, Esq.
Stephen J. Burdick, Esq.                            Catherine E. Kanatas, Esq.
Andrea N. Threet, Esq.                              Edward L. Williamson, Esq.
Mary Freeze, Assistant Audrea Salters, Legal Secretary                    E-mail:
mitzi.young@nrc.gov E-mail:                                            catherine.kanatas@nrc.gov pbessette@morganlewis.com                          edward.williamson@nrc.gov sburdick@morganlewis.com andrea.threet@morganlewis.com mfreeze@morganlewis.com                            OGC Mail Center :
asalters@morganlewis.com                            OGCMailCenter@nrc.gov
[Original signed by Clara Sola ]
Office of the Secretary of the Commission Dated at Rockville, Maryland this 21st day of December, 2015}}

Latest revision as of 05:58, 10 January 2025

Order (Setting Deadline for Proposed Transcript Corrections)
ML15355A440
Person / Time
Site: SHINE Medical Technologies
Issue date: 12/21/2015
From: Annette Vietti-Cook
NRC/SECY
To:
SECY RAS
References
50-608-CP, Mandatory Hearing 2, RAS 28683
Download: ML15355A440 (225)
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