ML16014A722

Order (Adopting Proposed Transcript Corrections, Admitting Post-Hearing Exhibits, and Closing the Record of the Proceeding)

ML16014A722
Person / Time
Site:	SHINE Medical Technologies
Issue date:	01/14/2016
From:	Annette Vietti-Cook NRC/SECY
To:
SECY RAS
References
50-608-CP, Mandatory Hearing 2, RAS 50854
Download: ML16014A722 (230)

Text

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 (Adopting Proposed Transcript Corrections, Admitting Post-Hearing Exhibits, and Closing the Record of the Proceeding)

The Commission held an evidentiary hearing at its Rockville, Maryland headquarters on December 15, 2015. The parties have provided proposed transcript corrections. The transcript corrections identified in Appendix A to this order are adopted. Appendix B to this order contains a revised hearing transcript that incorporates all of the adopted corrections.

In addition, the parties have submitted responses to post-hearing questions. As directed, these responses were filed as new exhibits, using the previously-established numbering scheme. Neither party objects to the admission of these new exhibits. Therefore, exhibits NRC-014 and SHN-030 are admitted into the evidentiary record. The Staff also has filed a revised exhibit, NRC-002-R, and represents that SHINE has no objection to its admission. This exhibit is admitted, and the previous version of the exhibit, NRC-002, is stricken from the record.

The adoption of transcript corrections and the admission into evidence of the new exhibits completes the procedural activities that remained pending at the conclusion of the mandatory hearing. The record of this proceeding is closed, effective as of the date of this order. This order is issued pursuant to my authority under 10 C.F.R. § 2.346(a) and (j).

IT IS SO ORDERED.

For the Commission NRC SEAL

/RA/ .

Annette L. Vietti-Cook Secretary of the Commission Dated at Rockville, Maryland, this 14th day of January, 2016.

APPENDIX A: Changes to the Transcript for the SHINE Medical Technologies, Inc.

Mandatory Hearing December 15, 2015 Page Line Correction 1 21 Change "JEFF BARAN" to "KRISTINE L. SVINICKI" 1 23 Change "KRISTINE L. SVINICKI" to "JEFF BARAN" 2 1 Add "AND WITNESSES" after "STAFF" 2 11 Insert STEPHEN MARSCHKE, S. Cohen & Associates before Jane Marshall 3 5 Replace HENNESY with HENNESSY 3 11 Delete Stephen Marschke, Sanford Cohen and Associates 5 16 Replace 189A with 189a 6 2 Replace 189A with 189a 7 22 Replace to this common with to the common 8 1 Replace NEPA Sections 102.2(a), (c) and (e) with NEPA Sections 102(2)(A), (C) and (E) 8 6 Add semicolon after "taken" 8 12 Add semicolon after "values" 9 1 Replace of witness with of witnesses 9 9 Replace the witness with the witnesses 9 10 Replace their name with their names 9 14 Replace Hennesy with Hennessy 9 13, 14 Replace Richard Van Bynum with Richard Vann Bynum 13 23 Replace HENNESY: with HENNESSY:

13 23 Replace Hennesy with Hennessy 18 2 Replace insure with ensure 19 2 Replace insure with ensure 19 17 Replace insure with ensure 19 18 Replace insure with ensure 20 14 Replace insure with ensure 20 25 Replace radiation with irradiation 23 3 Replace all together with altogether 25 11 Replace plan with plans 25 23 Replace licensed with license 26 24 Replace tank is which is with tank which is 27 3 Replace radiation with irradiation 27 8 Replace for the proper with to the proper 29 2 Replace than pass with then pass 32 18 Replace is discrete with in discrete 33 15 Replace of accelerator with of the accelerator 34 21, 22 Replace ATSV off gas system with eight TSV off gas systems, 36 16 Replace insure with ensure 39 3 Replace insure with ensure 40 17 Add comma after "phase" and add a question mark after "license" 40 23 Replace HENNESY: with HENNESSY:

40 24 Replace Hennesy with Hennessy 41 16 Replace HENNESY: with HENNESSY:

42 17 Change "presentation" to "panel" 43 24 Change "work" to "wrap"

Page Line Correction 44 14 Change "area" to "areas" 46 6 Change the period to a question mark after "financial" 47 23 Replace HENNESY: with HENNESSY:

48 5 Replace HENNESY: with HENNESSY:

48 25 Delete "for" 49 4 Replace "some" with "a" 49 7 Replace HENNESY: with HENNESSY:

50 3 Replace HENNESY: with HENNESSY:

50 12 Replace HENNESY: with HENNESSY:

50 8, 9 Replace "th is" with "this" 51 12 Replace ours with ours 52 5 Replace "your's" with "yours" 52 16 Replace insure with ensure 54 14 Change "explore" to "explored" 54 17 Change "insure" to "ensure" 55 5 Change "use" to "used" 55 8 Replace HENNESY: with HENNESSY:

55 18 Replace HENNESY: with HENNESSY:

57 11 Change Go to to Could I have 57 16 Change "technetium-99m stable" to "technetium-99 metastable" 60 1 Change "NMSA" to "NNSA" 60 23 Change "5034" to "50.34" 61 6 Change "or FSAR" to ", or FSAR,"

62 4 Change "insure" to "ensure" 64 5 Change walls to wall 64 8 Change "think" to "thin" 66 9 Change "review inform" to "review, inform" 67 17 Change "areas except" to "areas, except" 67 18 Change "traffic" to "traffic,"

68 14 Change "320" to "20" 70 12 Change SHINE stated to SHINE has stated 70 20 Change "criterion" to "criteria in" 73 17 Delete the comma after "support" and change "organization" to "organizations" 73 21 Delete "it's" 78 14 Delete "you think" 78 16 Change "has" to "have" 80 10 Change ours to ours 82 22 Insert em dash between "guidance" and "in" 82 23 Replace comma and space with em dash 83 3 Set off "I'll say" with commas 84 6 Delete the first "the" 86 15 Delete "is - -"

86 22 Change "action" to "actions" 87 20 Change "insure" to "ensure" 89 3 Change "concept" to "concepts"

Page Line Correction 90 10 Change "insure" to "ensure" 91 18 Change facilities to facility 92 14 Change "MR. LYNCH" to "MR. DEAN" 96 25 Add "that" after "Guidance" and add a comma after "used" 100 17 Change in your to many of the 100 18 Change ask the questions we practice to asked are questions we practiced 101 1 Change need to to need. To 101 3 Change permit. That to permit, that 101 12 Change MS. YOUNG to COMMISSIONER SVINICKI 102 8 Replace Hennesy with Hennessy 104 5 Replace in a radiation with and irradiation 104 6 Replace maintain at shutdown with maintain it shutdown 105 12 Replace commensurate what with commensurate with 105 15, 16 Replace single family criterion with single failure criterion 106 21 Delete "will discuss" 109 19 Change "nature" to "nature,"

109 21 Change "Part 70" to "Part 70,"

111 1 Change "Because of the" to "Because of their" 111 3 Change "reactors" to "reactors,"

112 16 Change "b" to "be" 112 19 Change application to application, 114 8 Replace "to" with "of" 115 5 Replace MR. VAN ABEL: with MR. HENNESSY:

115 8 Replace MR. VAN ABEL: with MR. HENNESSY:

116 19 Change "the" to "that" 116 25 Change "of" to "on" 117 3 Change "that we" to "would be" 117 15 Change "committing to" to "committing to to" 119 18 Change Thanks you. to Thank you.

119 3, 4 Change "And the" to "But in the" 120 14 Replace HENNESY: with HENNESSY:

120 23 Replace HENNESY: with HENNESSY:

121 3 Replace HENNESY: with HENNESSY:

121 5 Replace HENNESY: with HENNESSY:

122 2 Change COMMISSIONER BARAN to CHAIRMAN BURNS 122 5 Change that replaced to that were placed 122 23 Add "a" between "of" and "temporal" 125 18 Change traverse to transverse 126 2 Change "large" to "larger" 127 7 Change COMMISSIONER BARAN to CHAIRMAN BURNS 128 13 Add "a" after "got" 128 16 Replace HENNESY: with HENNESSY:

128 19 Replace HENNESY: with HENNESSY:

128 22 Replace HENNESY: with HENNESSY:

129 2 Replace HENNESY: with HENNESSY:

Page Line Correction 129 6 Replace HENNESY: with HENNESSY:

129 20 Replace I put with I was put 130 2 Replace will able with will be able 131 19 Replace sites with site 131 23 Replace sites with site 132 1 Replace sites with site 132 2 Replace and the with in the 132 3 Replace events with event 132 10 Change "analysis" to "analyses" 132 16 Change HULL to VAN ABEL 133 9 Change be either to be for either 133 13 Delete "are of course" 134 10 Delete "of" 136 9 Change "being" to "begin" 136 13 Replace HENNESY: with HENNESSY:

136 13 Replace Hennesy with Hennessy 136 20 Replace MR. COSTEDIO: with MR. VAN ABEL:

137 20 Replace preformed with performed 137 7, 8 Replace nuclear plant operations and engineering personal experience in reactor and nuclear process safety. with nuclear plant operations and engineering, personnel experienced in reactor and nuclear process safety.

138 8 Replace a radiation with irradiation 138 11 Replace in the pool with of the pool 138 11 Replace disburses with disperses 138 16 Replace filter with filtered 138 19 Replace work with worker 138 23 Replace designated with designate it 139 3 Replace store with stored 140 4 Replace duct. with stack.

140 17 Change as the to ask the 140 24 Change "Kevin Morrissey" to "Kevin Morrissey, Fuel Cycle Safety Review."

140 25 Change "Dave Lynch" to "Steve Lynch, Project Manager, Research and Test Reactors Licensing" 141 7 Change "Projection" to "Production" 142 19 Change facilities. The to facilities, the 143 1 Change radiation facility to irradiation facility 144 23, 24 Change "where gas is produced in the irradiation process or stored" to "where gases produced in the irradiation process are stored" 145 12 Change "RM." to "MR."

148 1 Add "to" after "witnesses" 151 14 Change engineering and safety to engineering safety 151 18 Change offsite conditions. to upset conditions.

152 6 Change Chris, to Chris Tripp, 152 17 Change "vessel" to "special"

Page Line Correction 153 4 Change KANATAS" to "KOLB" 153 11 Replace 176 with 1.76 153 17 Add question mark after "that" and capitalize "the" in "The one other thing" 153 17 Insert MR. LYNCH: before "The one other thing" 153 19 Change "rain, snow" to "rain-snow" 153 20 Change event? to event.

153 21 Change "MR. LYNCH" to "CHAIRMAN BURNS" 153 23 Change "CHAIRMAN BURNS" to "MR. LYNCH" 153 24 Change "MR. LYNCH" to "CHAIRMAN BURNS" 153 25 Change "CHAIRMAN BURNS" to "MR. LYNCH" 154 1 Change "MR. LYNCH" to "CHAIRMAN BURNS" 154 2 Delete "CHAIRMAN BURNS:"

154 9 Replace MR. VAN ABLE: with MR. VAN ABEL:

156 1 Change 15.20 to 1520 157 18 Add "you" after "Thank" 158 10 Change "MS. KANATAS" to "MS. KOLB" 158 17 Change "MS. KANATAS" to "MS. KOLB" 158 20 Change "MS. KANATAS" to "MS. KOLB" 159 1 Replace license with licensed 159 5 Replace a waste control specialist with at Waste Control Specialists 159 11 Change "KANATAS" to KOLB" 159 16 Change KANATAS to KOLB 159 19 Delete "broadly" 160 11 Replace thats on the license and operators. with thats how they license their operators.

160 25 Replace HENNESY: with HENNESSY:

161 18 Delete "in" and the second "the" 161 19 Delete "is" and replace with "that we've" 161 19 Replace the comma with a period and capitalize "is" 161 22 Replace "of" with "or" 161 24 Replace No, you know, have various with No - we have various 162 20 Delete "just for" 162 23 Replace "are" with "seem" 162 24 Delete "And," and capitalize "are" 162 3, 4 Replace monitor the activity in the neutron population in the TSV radiation. with monitor the reactivity and the neutron population in the TSV during irradiation.

163 4 Replace manual with manually 163 11 Replace there would with they would 163 18 Replace not only with nominally 163 19 Replace two dampers, but every place with two dampers at every place 163 8, 9 Replace many traces available with many choices available 164 19 Replace HENNESY: with HENNESSY:

164 19 Replace Hennesy with Hennessy

Page Line Correction 164 19, 20 Replace Manager of Engineer with Manager of Engineering 165 20, 21 Replace of the affect in the environment with of the affected environment 169 8 Replace alterative with alternative 171 25 Replace Sections 102.2(a), (c) with Sections 102(2)(A), (C) 171 5, 6 Replace both to Stevens Point and the Chippewa Falls with both to Stevens Point and to Chippewa Falls 172 1 Replace and (e) with and (E) 174 14 Change and to an 174 22 Change actions to action's 176 7 Change of the an EIS to of an EIS 177 12 Change "NEC" to "NRC" 178 23 Change "visited site" to "visited the site" 183 19 Change publically to publicly 185 13 Change "residents" to "resident" 186 20 Change medial to medical 187 12 Change "adjust" to "address" 189 21 Change "provides" to revised 191 4 Change "15" to "51" 192 24 Add a comma after "source" and change "an aging" to "are" 193 18, 19 Add a comma after "Where" and add quotation marks before "I" and after "technology" 194 17 Change "were" to "was" 198 3 Delete "I actually came at --"

199 12 Change "and" to "an" 200 6 Replace Trial entities with Tribal entities 200 23 Replace "Christinesville" with "Kristinesville" 201 17 Replace "NCR" with "NRC" 201 19 Replace "ways" with "Waze" 202 5 Insert "a" after "Katrina" 202 8 Insert "with" between "experience" and "the" 202 9 Delete comma, change "with" to "and," delete "regular" 202 10 Begin "Commercial Power Reactors" with lower case letters 202 13 Replace "doing" with "the" 203 15 Delete "just, you know,"

203 10, 11 Delete "just like, you know,"

204 1 Change several questions. to a separate question.

204 24 Replace didnt new time. with didnt add any time.

205 5 Replace "comments" with "comment" 205 5 Insert "the" before "NRC" 207 6 Replace Van Bynum with Vann Bynum 207 10 Replace Van Bynum with Vann Bynum 208 21 Change "You" to "We" 209 18 Change "I" to "it" 209 20 Delete "any that,"

210 8 Add "make" after "can" and change "it that" to "what"

Page Line Correction 218 3 Change "bear in town" to "Barantown" 218 5 Delete period after "immediately" 218 5 Add "that" after "immediately" and change capital "T" to lowercase 218 19 Change A conducted to A we conducted 218 24 Replace resumption with presumption 219 19 Delete "working at" 220 2 Insert "not" between "may" and "be" 221 9 Change the Commission to the Office of Commission 221 24 Add "be" after "probably" and change "issue" to "issued"

APPENDIX B: Corrected Transcript December 15, 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 1-220 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 KRISTINE L. SVINICKI 22 WILLIAM C. OSTENDORFF 23 JEFF BARAN 24 ALSO PRESENT:

25 ANNETTE L. VIETTI-COOK, SECY NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

2 1 NRC STAFF AND WITNESSES 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 STEPHEN MARSCHKE, S. Cohen & Associates 12 JANE MARSHALL, NRR 13 KEVIN MORRISSEY, NMSS 14 MICHELLE MOSER, NRR 15 JOSEPH STAUDENMEIER, RES 16 CHRISTOPHER TRIPP, NMSS 17 CARL WEBER, NRO 18 DAVID WRONA, NRR 19 MITZI YOUNG, OGC 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

3 1

2 APPLICANT AND WITNESSES PRESENT:

3 STEPHEN BURDICK, Morgan Lewis & Bockius 4 RICHARD VANN BYNUM, SHINE Medical Technologies 5 JIM COSTEDIO, SHINE Medical Technologies 6 BILL HENNESSY, SHINE Medical Technologies 7 CHRISTOPHER HEYSEL, Information Systems 8 Laboratories 9 ALAN HULL, Golder Associates, Inc.

10 CATHERINE KOLB, SHINE Medical Technologies 11 TIMOTHY KRAUSE, Sargent & Lundy 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 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

4 1 A G E N D A 2 Overview (SHINE Medical Technologies, 3 Inc.)..........................................13 4 Commission Q & A..................................36 5 Overview (NRC Staff)..............................55 6 Commission Q & A..................................71 7 Break............................................100 8 Safety - Panel 1.................................100 9 Commission Q & A.................................112 10 Break............................................133 11 Safety - Panel 2.................................134 12 Commission Q & A.................................146 13 Environmental - Panel............................162 14 Commission Q & A.................................189 15 Break........................................... 208 16 Closing Statement by Applicant...................208 17 Closing Statement by Staff.......................212 18 Commission Q & A and Closing Statements..........215 19 20 21 22 23 24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

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 things 6 before we begin this hearing.

7 I want to welcome the audience and those who 8 may be viewing this remotely on line. Welcome to the 9 Applicant, to the Staff, members of the public. And the 10 Commission is here today to conduct an Evidentiary 11 Hearing on the SHINE Medical Technologies application 12 for a construction permit for a medical radioisotope 13 production facility in Janesville, Wisconsin.

14 This hearing is required under Section 189a 15 of the Atomic Energy Act of 1954, as amended. And the 16 Commission will also be reviewing the adequacy of the 17 NRC Staff's Environmental Impact Analysis under the 18 National Environmental Policy Act of 1969, which many 19 of us refer to as NEPA.

20 This is the third so called mandatory or 21 uncontested hearing that the Commission has held this 22 year, but unlike the two previous ones, this one is for 23 a construction permit, not for a Combined License. But 24 the requirements for the necessity of a hearing on a 25 construction permit is required as I noted under Section NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

6 1 189a.

2 During the hearing, SHINE and the Staff 3 will provide testimony and witness panels that will 4 provide an overview of the application, as well as 5 address safety and environmental issues associated with 6 the review, and Commission questions will follow each 7 panel. And there will be a rotation of the Commissioners 8 from panel to panel, and the Commissioners may allocate 9 their total time among the panels as each Commissioner 10 sees fit.

11 In order to issue a construction permit the 12 Commission must make certain specific safety and 13 environmental findings. On the safety side, the 14 Commission will determine whether in accordance with 10 15 CFR 50.35(a), whether the Applicant has described the 16 proposed design of the facility, including the 17 principal architectural and engineering criteria for 18 the design, and whether the Applicant has identified the 19 major features or components incorporated therein for 20 the protection of the health and safety of the public.

21 Also, such further technical or design information as 22 may be required to complete the safety analysis, and 23 those which can be reasonably left for later 24 consideration to be supplied in the Final Safety 25 Analysis Report; whether safety features or components, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

7 1 if any, that require research and development have been 2 described by the Applicant, and the Applicant has 3 identified, and there will be conducted a research and 4 development program reasonably designed to resolve any 5 safety questions associated with such features or 6 components; and whether on the basis of the foregoing 7 there is reasonable assurance that, one, such safety 8 questions will be satisfactorily resolved at or before 9 the latest date stated in the application for completion 10 of the construction of the proposed facility; and, two, 11 taking into consideration the site criteria contained 12 in 10 CFR Part 100, the proposed facility can be 13 constructed and operated at the proposed location 14 without undue risk to the health and safety of the 15 public.

16 In making these findings, the Commission 17 will also be guided by the considerations in 10 CFR 18 Section 50.40 which include the Commission's opinion as 19 to whether the issuance of the construction permit will 20 not be inimical to the common defense and security or 21 to the health and safety of the public.

22 With respect to environmental matters, the 23 Commission will determine whether the requirements of 24 NEPA Sections 102(2)(A), (C) and (E), and the applicable 25 regulations in 10 CFR Part 51 have been met. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

8 1 Commission will independently consider the final 2 balance among conflicting factors contained in the 3 record of the proceeding with a view to determining the 4 appropriate action to be taken; determine after 5 weighing the environmental, economic, technical, and 6 other benefits against environmental and other costs, 7 and considering reasonable alternatives whether the 8 construction permit should be issued, denied, or 9 appropriately conditioned to protect environmental 10 values; and determine whether the NEPA review conducted 11 by the Staff has been adequate.

12 This meeting is open to the public, and we 13 do not anticipate the need to close the meeting to 14 discuss non-public information, but if a party believes 15 that a response to a question may require a reference 16 to non-public information, then I would ask the party 17 to answer the question to the best of its ability and 18 practicality with information that is on the public 19 record, and file any non-public response promptly after 20 the hearing on the non-public docket.

21 Before proceeding, do my fellow 22 Commissioners have anything they'd like to add? Then 23 we'll proceed with the swearing in of witnesses. We'll 24 start first with SHINE. I'd ask counsel for SHINE to 25 introduce himself.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

9 1 MR. BURDICK: Good morning. This is Stephen 2 Burdick from Morgan Lewis & Bockius, also joined by my 3 colleague, Paul Bessette. We are counsel for SHINE.

4 CHAIRMAN BURNS: Okay. Counsel, would you 5 read the names of the witnesses?

6 MR. BURDICK: Yes, and if the witnesses 7 would please stand when I read their names, and then 8 remain standing until the Chairman directs otherwise.

9 In alphabetical order SHINE's witnesses 10 are Joseph M. Aldieri, Jeffrey M. Bartelme, Richard Vann 11 Bynum, James Costedio, William Hennessy, Alan Hull, 12 Catherine Kolb, Timothy P. Krause, Thomas Krzewinski, 13 C. Michael Launi, James W. McIntyre, John B. McLean, 14 William D. Newmyer, Greg Piefer, Katrina M. Pitas, Erwin 15 T. Prater, Louis Restrepo, Eric N. Van Abel, George F.

16 Vandegrift, Tamela B. Wheeler, Ernest Wright, and 17 Steven L. Zander. Thank you.

18 CHAIRMAN BURNS: Okay, thank you.

19 Witnesses, I'd ask you to raise your right 20 hand to take the oath.

21 Do you swear or affirm that the testimony 22 you will provide in this proceeding is the truth, the 23 whole truth, and nothing but the truth?

24 ALL WITNESSES: I do.

25 CHAIRMAN BURNS: Did anyone fail to take the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

10 1 oath? Indicate so, otherwise. No. Thank you. You may be 2 seated.

3 Is there any objection to including the 4 witness list into the record?

5 MS. KANATAS: No objections.

6 CHAIRMAN BURNS: Okay, thank you, counsel.

7 And then with respect to -- we'll proceed 8 in terms of the admission of evidence on behalf of the 9 Applicant. Are there any edits to your exhibit list, 10 counsel?

11 MR. BURDICK: There are no edits.

12 CHAIRMAN BURNS: Okay. Would you read the 13 range of numbers of the exhibits to be admitted?

14 MR. BURDICK: Yes. SHINE has submitted 15 Exhibits SHN-001 through SHN-029.

16 CHAIRMAN BURNS: Okay. And I presume you 17 propose to move those into the record?

18 MR. BURDICK: We move to admit those into the 19 record.

20 CHAIRMAN BURNS: Okay. Is there any 21 objection?

22 MS. KANATAS: No objections.

23 CHAIRMAN BURNS: Okay, very good. So, the 24 list of exhibits is admitted for the Applicant, SHINE.

25 Okay. Turning to the Staff, counsel, would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

11 1 you introduce yourself, please.

2 MS. KANATAS: My name is Catherine Kanatas, 3 and along with my counsel, Mitzi Young, we represent the 4 Staff.

5 CHAIRMAN BURNS: Okay, great. Would you read 6 the names of the proposed Staff witnesses?

7 MS. KANATAS: Yes, and if they can --

8 CHAIRMAN BURNS: And I'll ask them to stand.

9 Thank you.

10 MS. KANATAS: Thank you. Alexander Adams, 11 John Adams, Mary Adams, Stephen Alexander, David Back, 12 Marissa Bailey, Daniel Barrs, Thomas Boyle, Gregory 13 Chapman, William Dean, James Downs, Thomas Essig, Kevin 14 Folk, Mirela Gavrilas, Mary Gitnick, James Hammelman, 15 Shawn Harwell, Christopher Heysel, Gregory Hofer, 16 Robert Hoffman, Anthony Huffert, Steven Lynch, Stephen 17 Marschke, Jane Marshall, Nancy Martinez, James 18 McIlvaine, Diane Mlynarczyk, Kevin Morrisey, Michelle 19 Moser, Thomas Pham, Paul Prescott, William Rautzen, 20 Jeffrey Rikhoff, Michael Salay, Alexander Sapountzis, 21 Raymond Skarda, Soly Soto-Lugo, Joseph Staudenmeier, 22 Christopher Tripp, Glenn Tuttle, Carl Weber, Abraham 23 Weitzberg, and David Wrona.

24 CHAIRMAN BURNS: Okay, thank you.

25 So, for the Staff witnesses, I'll ask you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

12 1 to raise your right hand.

2 Do you swear or affirm that the testimony 3 you will provide in this proceeding is the truth, the 4 whole truth, and nothing but the truth?

5 ALL WITNESSES: I do.

6 CHAIRMAN BURNS: Did any -- please inform me 7 if any of you decline to take the oath. Okay, you may 8 be seated.

9 Is there any objection to including the 10 witness list?

11 MR. BURDICK: No objection.

12 CHAIRMAN BURNS: Okay. So, proceed to the 13 admission of the evidence on behalf of the NRC Staff.

14 Are there any edits, counsel, to your exhibit list?

15 MS. KANATAS: There are no edits.

16 CHAIRMAN BURNS: Would you read the range of 17 numbers on the list of exhibits to be admitted?

18 MS. KANATAS: Staff exhibits run from 19 NRC-001 through NRC-013.

20 CHAIRMAN BURNS: Okay. And I presume you 21 would move to admit those exhibits into evidence.

22 MS. KANATAS: We would like to move to admit 23 them into the record.

24 CHAIRMAN BURNS: Are there any objections?

25 MR. BURDICK: No objection.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

13 1 CHAIRMAN BURNS: Okay. And seeing no 2 objection, the exhibits are admitted. So, thank you for 3 those -- we got through the preliminaries.

4 I think at this point we're ready to have 5 the Overview Panel for SHINE. And for this portion of 6 the proceeding we'll have the Overview Panel from SHINE, 7 and I believe then we have the questions on the Overview 8 Panel, and then we'll have the Staff Panel. So, thank 9 you, counsel.

10 And, again, this is an Overview Panel for 11 opportunity for the Applicant to provide us overview of 12 the application and the proposed project. I would remind 13 the witnesses that you remain under oath. You may assume 14 that the Commission is familiar with the pre-hearing 15 filings on behalf of the Applicant, as well of the Staff.

16 And I would then ask the panelists to introduce 17 themselves. I'll start here.

18 MR. PIEFER: Yes, sir. My name is Greg 19 Piefer. I'm the founder and CEO of SHINE Medical.

20 MR. HENNESSY: My name is Bill Hennessy. I'm 21 the Manager of Engineering for SHINE.

22 MR. COSTEDIO: My name is Jim Costedio. I'm 23 the Licensing Manager for SHINE.

24 MR. VAN ABEL: My name is Eric Van Abel. I'm 25 the Engineering Supervisor for SHINE.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

14 1 CHAIRMAN BURNS: Okay. Thank you, 2 gentlemen. And you may proceed with your presentation.

3 MR. PIEFER: So, once again, my name is Greg 4 Piefer, and I want to thank the Commission, 5 Commissioners, Mr. Chairman for your consideration of 6 this very important matter. To start it off, I'd like 7 to give you guys a little bit of background on SHINE and 8 our mission as a company.

9 SHINE Medical Technologies is dedicated to 10 being the world leader in the clean, affordable 11 production of medical tracers and cancer treatment 12 elements commonly known as medical isotopes by the 13 medical community.

14 We recognize fully that in order to run this 15 business successfully our highest priority needs to be 16 on safety and reliability of the processes used to 17 produce these isotopes. At the end of the day, these 18 products will serve the needs of approximately 100,000 19 patients per day around the globe making this a very, 20 very significant endeavor in terms of health care of 21 patients. Of course, we can't operate the plant at all 22 if we're not focused on safety in our house, and so those 23 are the highest sort of values within the company.

24 Also interesting is that we come with this 25 technology to the market at a very interesting time when NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

15 1 there is a tremendous amount of transition happening in 2 the existing supply chain for these medical isotopes.

3 Currently, the only producer in the Western Hemisphere 4 of any significant volume will be leaving the market 5 permanently in 2018, and the products have a 66-hour 6 half-life, the most commonly used product has a 66-hour 7 half-life, and that creates substantial challenges for 8 U.S. patients here if we need to bring all of our medical 9 isotopes from overseas. Next slide, please.

10 Just a little bit more background on the 11 primary medical isotope that the world uses.

12 Molybdenum-99 decays into a daughter, technetium-99m, 13 and is used in about 85 percent of the nuclear medicine 14 scans performed globally.

15 Technetium-99m is extremely versatile. Its 16 chemistry allows it to attach itself to a wide variety 17 of drugs where it acts as a tracer, and essentially 18 allows doctors to see what that drug is doing. It has 19 a 6-hour half-life and so it is very difficult to 20 distribute as technetium, but because it's a daughter 21 of molybdenum-99 which has a 66-hour half-life, you can 22 distribute it around the globe fairly easily.

23 Collectively, these procedures make up 24 about 40 million doses on an annual basis, so very, very 25 high volume, and very important to patients all around NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

16 1 the world, the U.S. being approximately half of those 2 doses.

3 The pie chart included on Slide 3 shows a 4 breakdown of the procedures primarily that use 5 technetium-99m. I'm just going to call your attention 6 to two of the slices. The largest slice is labeled 7 myocardial profusion. Myocardial profusion is just a 8 way of saying looking at blood flow through the heart 9 muscle and, in fact, is commonly known as a stress test.

10 If a doctor wants to know where to put a stent, if a 11 patient is having chest pain they'll do this. If they 12 want to see if the heart has been damaged by a heart 13 attack, they'll do this test, so very, very useful when 14 you look at the number one killer of human beings in the 15 United States, cardiac disease. And the number two use 16 is for something called a bone scan which is used to 17 stage cancer. And that is the number two killer of people 18 in this country. So, very important products, very 19 widely used today, and it's very important that the 20 supply chain remain robust for many, many years to come.

21 Next slide, please.

22 However, it is not clear that the supply 23 chain will remain resilient on the current track without 24 new production. In fact, it looks like it will not be 25 able to meet the needs, the growing needs of the globe NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

17 1 in terms of medical isotope production.

2 I mention the Canadian reactor is exiting 3 the market permanently in March of 2018, and they 4 actually plan to decommission that reactor, at which 5 time the Western Hemisphere will not have a source 6 barring new entrants coming in. And this is not going 7 to create just a problem over here, but it's going to 8 create a global problem. In fact, the Nuclear Energy 9 Agency as part of the Organization of Economic 10 Cooperation and Development has been performing studies 11 on exactly this situation for the last several years, 12 and we've included a small bit of data from the most 13 recent study which shows current demand growth in the 14 green line, and current production capacity in the 15 orangish line. As you see, it kind of dips down when 16 Canada leaves.

17 I'll note that this demand graph does 18 include something called outage reserve capacity and 19 so, you know, there's a little buffer on what's actually 20 required, but that's important. That's what the market 21 needs in order to operate reliably and ensure that 22 patients can get the products they need and manage the 23 occasional outage because the supply chain is on the 24 order of 50 to 60 years old in most cases, the research 25 reactors producing this isotope.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

18 1 So it's a very, very, I think, stressful 2 situation for the medical community right now not 3 knowing where their answers are going to lie in the long 4 term, and that problem creates an opportunity for new 5 technology to come in and sort of change the way we've 6 been making medical isotopes in this country, and really 7 do it in a better way. And that's what we believe we've 8 done here. You're going to hear a lot more about how we 9 plan to do that as the day goes on.

10 But when we developed this technology, 11 we've been working on it since about 2006, we had some 12 core values as a company when we founded the company that 13 really are embodied by the technological approach 14 you're going to hear about. And, obviously, as I 15 mentioned in the beginning, we believe at the very 16 highest level that it is impossible to run this company 17 without protecting the health and safety of our workers, 18 the public, and the environment, so these have been 19 factors in our consideration from day one when we were 20 looking at what technologies to choose and what approach 21 to go forward on.

22 On top of that, we need to ensure based on 23 the short half-life of these products that we can get 24 the product out regularly, on time every time. Again, 25 with 66 hours2.75 days <br />0.393 weeks <br />0.0904 months <br />, you know, there's really no forgiveness NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

19 1 for substantial delays. It just means that patients 2 aren't going to get the products they need if you can't 3 deliver. And that's unfortunate if a patient presents 4 with chest pains and a doctor is concerned they may have 5 had a heart attack and has to tell them to come back, 6 you know, maybe in a week and hope you make it, or has 7 to give them an alternative isotope that will leave them 8 radioactive for weeks. Stay away from small children for 9 quite some time. It's just not good for the patients, 10 so we need to get this out every single time.

11 We also needed to ensure 12 cost-effectiveness. We had to ensure an approach that 13 would allow us to make medical isotopes that can be 14 bought. You know, it's a time when reimbursement is 15 generally across the board decreasing in the United 16 States, and it's important that a cost-effective 17 technology be developed so that this doesn't become 18 prohibitive in terms of cost for patient access.

19 And, finally, something that's been very 20 strong in our minds since the beginning is that it's not 21 necessary to use highly enriched uranium to make medical 22 isotopes; however, it is commonly used around the globe 23 today. So, we designed our process to eliminate the need 24 for highly enriched uranium and, in fact, use only low 25 enriched uranium as part of our process.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

20 1 The risk posed to the U.S. public by the 2 proliferation of highly enriched uranium is extremely 3 high. If there were to be an event, the consequences 4 would be disastrous, and we fully support the U.S.

5 Government's initiatives to remove highly enriched 6 uranium from the supply chain and, in fact, stop 7 shipping it around the world to ensure that we have 8 appropriate medical tracers.

9 So, these are all things that drove our 10 mission and drove our values, or drove our technology 11 rather. So, I'm going to just give you a high level view 12 of the technology and how it reflects those values.

13 Fundamentally, the biggest protection that 14 we have is that these systems have been designed to be 15 small, and I'm talking about small in terms of thermal 16 power equivalent. When you look at a SHINE production 17 unit or irradiation unit, you'll hear more about this 18 throughout the day, the thermal power of one of these 19 systems is on the order of 100 kilowatts when its 20 producing at full tilt. If you were to compare this to 21 a reactor like the NRU which is also producing medical 22 isotopes today, that reactor's thermal power equivalent 23 is 135 megawatts, so there's about a factor of 1,000 24 difference in thermal power from a SHINE-based system 25 to a reactor-based system. And that has tremendous NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

21 1 safety benefits for us, including low source term and 2 very low decay heat. If we shut one of our systems within 3 hours0.125 days <br />0.0179 weeks <br />0.00411 months <br />, just a few hours we're down to about a kilowatt 4 of decay heat, so we're talking about something that's 5 less than a hair dryer. So you don't have a lot of the 6 concerns you would have with loss of power in much larger 7 facilities.

8 In addition to the safety benefits just 9 from the lower source term and lower decay heat, of 10 course, we're producing less radionuclides overall that 11 a much larger reactor would do, and that allows us to 12 use commercial disposal for much, if not all, of our 13 disposal path. It's a great economic benefit and 14 certainty benefit in terms of final disposition of waste 15 products.

16 Secondly, we developed a low enriched 17 uranium target that is not only novel in terms of being 18 aqueous, the target is in a liquid form, but it's also 19 the first target that I'm aware of that is reusable. And 20 the reusability of our target actually gives us a 21 substantial economic advantage.

22 Currently in the supply chain, metal 23 targets are used, solid targets are placed next to a 24 reactor core. They're irradiated. Much of the uranium 25 does not fission, they're dissolved and the medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

22 1 isotopes are extracted out, and the rest of the uranium 2 is essentially thrown away. Well, in fact, since it's 3 highly enriched uranium in most of these cases, it's 4 thrown into tanks and very carefully monitored. But the 5 reusable target for us is a major, major improvement.

6 And, finally, the system is driven by a low 7 energy electrostatic accelerator. I say low energy, 8 that's about 300 kilovolts, 300 kilo electron volts beam 9 energy. And if you were to compare that to a cyclotron 10 that would be found in a pharmacy today that makes 11 isotopes such as fluorine-18, those are on the order of 12 10 MeV, Mega Electron Volts, so it's much lower, much 13 simpler accelerator that we're using to drive this 14 target. And that also allows us to operate below 15 criticality.

16 Some liquid reactors have been operated in 17 the past and they operate at criticality with control 18 rods. We've chosen for a number of reasons to eliminate 19 criticality altogether and use this accelerator system 20 to drive the liquid target. And that gives us, again, 21 substantially less waste by eliminating the need for a 22 reactor as the primary neutron source. It is also 23 proven, demonstrated, and fairly cost-effective 24 technology that actually people can come and see if 25 they'd like. It's in our lab.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

23 1 So, I guess that concludes my presentation.

2 I'm going to turn the rest of the overview over to Jim 3 Costedio.

4 MR. COSTEDIO: Good morning. Next slide, 5 please.

6 The SHINE facility is located on a 7 previously undeveloped 91-acre parcel in the southern 8 boundaries of the City of Janesville in Rock County, 9 Wisconsin. If you look at the map, the area outlined in 10 red on the southern boundary is Rock County. Next slide, 11 please.

12 The SHINE facility layout consists of an 13 irradiation facility or the IF, and a radioisotope 14 production facility, or the RPF. The area outlined in 15 blue is the irradiation facility which houses the 16 irradiation units, and the area outlined in red is the 17 radioisotope production facility which houses the hot 18 cells. The facility is relatively small compared to the 19 size of the parcel. It's a 91-acre parcel, and the 20 facility is about 55,000 square feet centered 21 approximately in the middle of the parcel. Next slide, 22 please.

23 The SHINE IF consists of eight subcritical 24 irradiation units which are comparable in thermal power 25 level and safety considerations to existing non-power NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

24 1 reactors licensed under 10 CFR Part 50. However, due to 2 the subcriticality, the irradiation units did not meet 3 the existing definition of utilization facility in 10 4 CFR 50.2. To align the licensing process with the 5 potential hazards, the NRC issued a direct final rule 6 modifying 10 CFR 50.2 definition of utilization 7 facility to include the SHINE irradiation units. An 8 irradiation unit consists of a subcritical assembly, a 9 neutron driver and supporting systems. Next slide, 10 please.

11 The radioisotope production facility is a 12 portion of the SHINE facility used for preparing target 13 solution, extracting, purifying, and packaging 14 moly-99, and the recycling and cleaning of target 15 solution. Based on the batch size of greater than 100 16 grams, the RPF meets the definition of a production 17 facility as defined in 10 CFR 50.2. Next slide, please.

18 SHINE submitted a construction permit 19 application in two parts pursuant to an exemption from 20 10 CFR 2.101. Part one of the application was submitted 21 on March 26, 2013 which included PSAR Chapter 2 on site 22 characteristics, PSAR Chapter 19 for the environmental 23 review, and general and financial information. Part two 24 of the application was submitted May 31st, 2013 which 25 provided the remaining PSAR chapters. And then a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

25 1 discussion of preliminary plans for coping with 2 emergencies in accordance with 10 CFR 50.34(a)(10) was 3 provided September 25th, 2013. The SHINE facility will 4 be licensed under 10 CFR Part 50, Domestic Licensing of 5 Production and Utilization Facilities. Next slide, 6 please.

7 SHINE used for regulatory guidance and 8 acceptance criteria, SHINE used NUREG-1537 guidelines 9 for preparing and reviewing applications for licensing 10 of non-power reactors, and the Interim Staff Guidance 11 augmenting NUREG-1537 Parts 1 and 2. The ISG 12 incorporated relevant guidance from NUREG-1520, a 13 Standard Review Plan for the review of a license 14 application for a fuel cycle facility. SHINE also used 15 additional guidance such as regulatory guides and ANSI 16 Standards in developing the application.

17 That ends my presentation. I'll now turn it 18 over to Eric Van Abel to discuss the SHINE technology.

19 MR. VAN ABEL: Next slide, please.

20 Good morning. I want to give a brief 21 overview of the process and technology that SHINE plans 22 on using. In this slide, as Jim showed there, there's 23 two main areas of the production facility building.

24 There's an irradiation facility, an IF, and a 25 radioisotope production facility, an RPF. I'm going to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

26 1 go through the processes in these two areas in the next 2 few slides. Next slide, please.

3 Here's a general schematic of the overall 4 SHINE process overview. Just to orient you relative to 5 the last figure, the TSV and Irradiation Unit Cell in 6 the left there is part of the irradiation facility, and 7 the other components on this diagram are all part of the 8 RPF.

9 So, we begin our process in the bottom there 10 at the target solution preparation step. In that process 11 we dissolve uranium in sulfuric acid and produce what 12 we call target solution. That target solution is then 13 moved to a hold tank which is number 2 on the figure 14 there. There's one of these hold tanks for each of our 15 eight irradiation units so there's eight hold tanks.

16 Those hold tanks are staging areas prior to the 17 irradiation cycle, so in that hold tank we'll measure 18 the uranium concentration, the pH to insure that the 19 parameters are correct to begin the irradiation cycle.

20 And then once we're ready to begin we'll start pumping 21 that solution over to the TSV in discrete batches. We'll 22 fill up the TSV to the proper level and then once the 23 TSV is at the proper level we begin the irradiation 24 process by energizing the neutron driver which is our 25 accelerator that Greg mentioned.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

27 1 That accelerator runs for approximately 2 five and a half days. We irradiate the solution, produce 3 medical isotopes of interest in the solution, and then 4 we -- once we're done with the irradiation process we 5 drain that solution to a dump tank located right in the 6 irradiation unit cell.

7 The solution is held there for a short 8 period to decay, and then once we're ready to process 9 it we transfer it over to the super cell, which is number 10 4 on the figure there. The super cell is just a larger 11 hot cell that has several processes inside a single hot 12 cell. And the first part of that process is the 13 extraction process. And that's where we actually 14 separate out the moly-99 from the other isotopes in the 15 solution.

16 And then most of the time the uranium 17 solution just goes right on to the recycle tank which 18 is number 5 in the figure. And there it's just recycled 19 back into the process and it goes in a loop. It goes to 20 another hold tank, to another irradiation cycle.

21 Occasionally, we also send it to the UREX 22 process which is item 6 in the figure there. And that's 23 where we periodically clean up the solution, we remove 24 the uranium from the other fission products using 25 solvent extraction technology UREX, and we recover the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

28 1 uranium and recycle that back into the process. So, we 2 just send that back to the target solution preparation 3 steps and recreate target solution again. Next slide, 4 please.

5 In the irradiation facility, SHINE has a 6 system that couples fusion and fission technology, so 7 we have an accelerator that's fusion-based, 8 deuterium-tritium fusion-based accelerator coupled to 9 a fission-based subcritical assembly. The little 10 diagram on the right there shows a schematic of that 11 process. In the accelerator we accelerate deuterium 12 ions into a tritium gas target. That results in the 13 production of fusion neutrons, 14 MeV fusion neutrons.

14 Those neutrons then pass through a component we call the 15 neutron multiplier. In that multiplier the yield of 16 neutrons is increased and then the neutrons are 17 transferred into the target solution. The target 18 solution is where the uranium is actually located.

19 In the target solution there's subcritical 20 multiplication so the fission occurs, it causes more 21 fission but in a subcritical process. And then that 22 fission yields the radioisotopes of interest directly 23 in the solution for ready extraction from the solution.

24 There are additional supporting systems 25 including a light water pool system. The entire system NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

29 1 is located in a pool similar to a research reactor. The 2 target solution vessel off gas system, as I'll mention 3 in a few slides here, manages the gas products from the 4 fission process. The primary closed loop cooling 5 systems cools the TSV during the irradiation process, 6 and there's a tritium purification system that supplies 7 clean gases to the accelerator for the irradiation.

8 It's important to note that this process is 9 done at essentially atmospheric pressure. It's a low 10 temperature, low pressure process. These aren't highly 11 pressurized, high temperature systems like a power 12 reactor would be. The target solution at the end of the 13 irradiation cycle is simply drained to a dump tank, as 14 I mentioned, right in the irradiation unit so that's a 15 passively cooled, safe-by-geometry tank to store the 16 solution. And that's drained through redundant 17 fail-open dump valves.

18 The TSV itself is just an annular, a simple 19 annular vessel constructed of Zircaloy, a widely used 20 alloy in the nuclear industry. And there's no pumping 21 of the solution while irradiating it. It's just 22 naturally convected inside of the vessel. Next slide, 23 please.

24 This slide shows just a rendering of the 25 subcritical assembly. The outer vessel in the center NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

30 1 there is the subcritical assembly support structure, 2 the SASS. This is a secondary vessel that surrounds the 3 TSV. The TSV is internal to that along with the neutron 4 multiplier. SASS is just there in case there's a leak 5 in the TSV, that solution would be contained inside of 6 that. The dump tank is located directly below it there, 7 and there are dump and overflow lines from the TSV to 8 the dump tank to connect it. Next slide, please.

9 So we were just looking at the components 10 in red on this figure. Directly above that is the 11 accelerator. The accelerator sits on a grating above the 12 pool and the accelerator is in yellow in this picture.

13 It's an electrostatic accelerator, a simple accelerator 14 technology. As Greg pointed out before, it generates 15 fusion neutrons from DT fusion that drive the fission 16 process. When we shut down the accelerator, the fission 17 process terminates because the subcritical assembly is 18 never at critical.

19 The tritium purification system is not 20 shown in this figure, but it's also in the irradiation 21 facility. And that system separates gases from the 22 accelerator, so the accelerator as it's operating, it's 23 mixing deuterium and tritium together. The tritium 24 purification system separates those back apart and 25 resupplies the purified tritium back to the accelerator NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

31 1 for continued operation. And the tritium lines for that 2 system and the processing equipment are in glove boxes 3 and double-walled pipe. Next slide, please.

4 The TSV off-gas system is shown in green on 5 the figure here. That system is directly adjacent to the 6 irradiation unit cells. That system contains the 7 fission product gases that are generated in the TSV 8 during irradiation. It removes iodine from the gas 9 stream, and also its major function is to recombine 10 hydrogen and oxygen. So as we irradiate the solution, 11 radiolysis of the water generates hydrogen and oxygen, 12 and this system sweeps sweep gas air over the target 13 solution vessel to dilute the hydrogen and send it to 14 a recombiner, and then recombine the water and return 15 that water back to the TSV, so it's just a closed loop.

16 The subcritical assembly, as I mentioned 17 before, is immersed in a light water pool. That pool 18 provides significant radiation shielding and decay heat 19 removal. Next slide.

20 For the irradiation process, when we're 21 ready to begin the irradiation we measure the relevant 22 parameters of the target solution, such as uranium 23 concentration, pH, any other chemical parameters that 24 we need to determine, and then we begin moving the 25 solution in discrete batches over into the target NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

32 1 solution vessel. We measure the count rate at each step 2 there and from that we can do the 1/M process that's used 3 in reactors all over the world to predict the critical 4 state of the assembly. And the difference with us is that 5 we increase volume, we predict where the critical state 6 is, and we never go there. We stop 5 percent by volume 7 below critical. And that's our highest reactivity point 8 for the system.

9 And during that process there are automatic 10 safety systems that are monitoring and will initiate a 11 shutdown on high neutron flux or primary coolant 12 temperature should the operators not stop the system 13 before that. And that would prevent a criticality. Next 14 slide, please.

15 Once we begin the irradiation process we 16 isolate that batch of uranium solution in the TSV so it's 17 a fixed target, fixed batch of solution. We close the 18 fill valves, the redundant fill valves and isolate the 19 fill pump from the system. We energize the accelerator, 20 and then we begin slowly supplying tritium to the 21 accelerator and that causes the output of the 22 accelerator to gradually increase, and that increase in 23 the neutron output of the accelerator results in 24 increased fission power in the TSV. That fission power 25 results in increased temperature and void fraction in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

33 1 the TSV which the system has very strong inherent 2 negative feedback coefficients so the increase in 3 temperature and void fraction causes reactivity to drop 4 significantly in the system. And we don't do anything 5 to compensate for the reactivity drop. We let the system 6 drive further subcritical.

7 We do this for approximately five and a half 8 days, and then following shutdown we drain the solution 9 into that dump tank where it's passively cooled.

10 Normally, we're maintaining the temperature of that 11 pool but should we lose offsite power or active cooling 12 for any reason of the pool, there's sufficient heat 13 capacity in the pool for a temperature rise of only 12 14 degrees after 90 days without cooling, so it's a large 15 body of water. There's very little decay heat because 16 this is such a small system. Next slide, please.

17 In the radioisotope production facility 18 once we're ready we transfer that solution over to the 19 RPF and there we extract the moly-99. We have a 20 purification process that it then goes to. This is the 21 LEU modified Cintichem process where it's a laboratory 22 scale glassware process that's done in the hot cell just 23 to purify the product. And then we package it and get 24 it ready for shipment to customers.

25 In the RPF there's also a noble gas removal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

34 1 system, the NGRS. This system collects those off gases 2 from the TSV off gas systems, the eight TSV off gas 3 systems, stores them, holds them for decay for 40 days 4 prior to sampling, and then a filtered monitored 5 discharge to our process vessel vent system.

6 Also in the RPF is the processes for 7 recycling and cleaning the target solution, the UREX 8 process. That's, as I mentioned before, a solvent 9 extraction process that separates the fission products 10 and plutonium from the uranium. The uranium is recovered 11 for reuse in the process. Next slide, please.

12 In the SHINE facility we used engineered 13 safety features to protect public health and safety, and 14 these are principally confinement. It's important to 15 note that our inventory in any one of these confinement 16 areas is approximately 10,000 times less than the 17 radionuclide inventory in a power reactor, so they're 18 much lower inventory which reduces the risk. And also 19 these are low temperature, low pressure processes so 20 there's not a lot of stored energy to encourage 21 dispersal, so there's lower dispersion forces which, of 22 course, reduces releases.

23 The confinement functions themselves are 24 provided by the biological shielding. There's -- over 25 most of the processes there's thick reinforced concrete NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

35 1 biological shielding, usually several feet thick 2 concrete. Isolation valves on the piping systems, 3 ventilation systems play an important role in the 4 confinement features. As shown in the figure on the 5 right there, that shows you some of our cascaded 6 ventilation zones. From Zone 1 to Zone 4 there's a 7 pressure gradient with Zone 1 being at the lowest 8 pressure, so any potential contamination is reduced 9 outside of those areas in Zone 1 where radiological 10 materials are normally stored. And in any accident 11 scenario, those areas in red on the figure there are the 12 areas where isolation would principally occur and 13 contain that material should an accident occur. And 14 also, of course, instrumentation and control systems 15 that actuate the confinement features. Next slide, 16 please.

17 So as described in SHINE's PSAR, we have a 18 preliminary design that shows that we can construct this 19 facility to meet the applicable regulatory 20 requirements. We've identified robust engineered and 21 administrative controls to ensure that we can protect 22 public health and safety, the environment, and our 23 workers, and that we are certainly designing this plant 24 with safety as our primary criterion. And that concludes 25 my presentation.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

36 1 CHAIRMAN BURNS: Does that conclude the 2 presentations?

3 MR. PIEFER: It does.

4 CHAIRMAN BURNS: Okay, thank you. Starting, 5 we'll have Commissioner questions now. We'll start 6 -- I'll start off this round of questioning.

7 Just to make sure I understand the design 8 facility laid out, each of these individual -- the eight 9 TSVs, these are essentially independent. Correct?

10 MR. VAN ABEL: Yes. Yes, they can be operated 11 independently run. We can run anywhere from zero to 12 eight of them.

13 CHAIRMAN BURNS: Okay. So, there's no real 14 interconnection between them.

15 MR. VAN ABEL: There are some shared 16 systems, like the ventilation system is common to them.

17 There's a common chilled water system that's supplying 18 chilled water to the heat exchangers.

19 CHAIRMAN BURNS: Okay.

20 MR. VAN ABEL: But the individual primary 21 cooling systems are unique for each one.

22 CHAIRMAN BURNS: Okay, thank you.

23 A couple of questions. Could you give me an 24 idea of what level of public engagement you had in terms 25 of the site selection process for the facility, and the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

37 1 type of feedback you got from that? I guess, Mr. Piefer, 2 that might be for you.

3 MR. PIEFER: Yes. I actually would like to 4 call Katrina Pitas to the witness stand.

5 CHAIRMAN BURNS: Okay.

6 MR. PIEFER: She's got that pretty 7 thoroughly. Are you ready?

8 MS. PITAS: I think so.

9 MR. PIEFER: Okay.

10 CHAIRMAN BURNS: Well, come -- Ms. Pitas, 11 come up to the podium here. And what I'd ask you to do, 12 and just for other witnesses, when you come up identify 13 yourself, your position. And I remind you you're -- and 14 I presume you took the oath. Yes, I saw you take the oath, 15 and you remain under oath.

16 MS. PITAS: Thank you.

17 CHAIRMAN BURNS: So, thanks.

18 MS. PITAS: So, my name is Katrina Pitas. I'm 19 the Vice President of Business Development for SHINE.

20 Our site selection process involved 11 21 criteria which I'd be happy to go through, but in terms 22 of public involvement, the individual community 23 governments that we were working with during the later 24 stages of our site selection process were very -- we had 25 a very good relationship with all three of the sites that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

38 1 we considered, the specific sites that we considered.

2 And then once we chose Janesville, that relationship has 3 continued to grow, and we believe we have a very good 4 relationship with that community. And I'd be happy to 5 go into some of the actions we've taken to ensure a good 6 relationship with the community, if you'd like.

7 CHAIRMAN BURNS: Well, I just -- yes, 8 briefly.

9 MS. PITAS: Sure. So, once we chose 10 Janesville, we set up twice yearly public meetings that 11 were open to the entire community. They were just 12 informational sessions where Greg would give a 13 presentation on our progress, the type of facility, and 14 what the company was aiming to do in the community. And 15 then we also have recently started giving twice yearly 16 updates to the city council which are open sessions, so 17 that makes a total of four times a year we meet directly 18 with the community. It's open to anyone to ask whatever 19 questions they have, voice concerns. And the result of 20 that has been truly -- a relationship based on mutual 21 respect and trust. So, it's been very positive.

22 CHAIRMAN BURNS: Thank you very much.

23 The other question I have goes to the nature 24 of what the application is for, which is a construction 25 permit. As I noted earlier, more recently the Commission NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

39 1 has been -- has held hearings on Combined Licenses which 2 is by intention a more comprehensive review, maybe not 3 more comprehensive but it's a broader scope of review 4 because it is actually the construction permit and the 5 ultimate operating 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 current 9 generation of operating plants in the U.S., going 10 through the construction permit process allows some 11 completion of certain design features, updating all 12 that.

13 Could you give me sort of a feel of, if a 14 construction permit is issued, what are, in effect, the 15 things you would see that need to be worked on from a 16 design perspective before we come to the next phase, 17 which would be the operating license? What are the 18 things that are still, in a sense, open? And I don't mean 19 open in a negative way, but it's the idea that the 20 Applicant may have some design issues that it needs to 21 address and to resolve prior to a final determination 22 on operating license.

23 MR. HENNESSY: I'll take this one. This is 24 Bill Hennessy, the Engineering Manager.

25 The state of our design right now is a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

40 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 design 15 from paper to the actual facility and all that.

16 MR. HENNESSY: 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 was 24 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

41 1 about. This is a significant new facility and capability 2 for that kind of a more agricultural and rural area. I 3 appreciate that you have done a lot of community 4 education and awareness of this activity. I might 5 suggest to you that if the construction permit is issued 6 and large-scale construction activities start taking 7 place, I think you might have to cover some of the same 8 territory because that's when the community really 9 becomes engaged and very interested when they start 10 noticing all of that activity. And then they will -- a 11 number of them I'm sure will begin their inquiry into 12 exactly what you're doing there. So, it's good that 13 you've got the structure in place to begin to educate 14 and communicate with people about what it is that you 15 are undertaking.

16 I note also, this is an overview panel so 17 I'm going to ask some questions that may or may not have 18 a direct relevance to the findings that the Commission 19 will make in order to make a decision on authorizing the 20 construction permit per se.

21 You provided in your overview presentation 22 some NEA statistics on the projected growth in the use 23 of the product that would come out of the SHINE facility.

24 I don't believe, though, that those projections give any 25 indication of the great swaths of the globe where people NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

42 1 are medically under-served and so it doesn't really 2 capture upon the demonstration of a new technology that 3 doesn't use HEU the potential long term maybe to have 4 more penetration of these types of diagnostic 5 techniques where arguably in medically under-served 6 areas of the globe they could do even greater good than 7 they do in areas that have access to a lot of 8 alternatives, or perhaps more invasive procedures.

9 So, it is interesting that there is a large 10 public good that comes out of constructing a facility 11 like this. Of course, that cannot have a direct bearing 12 on a safety determination. The facility, you know, 13 either is or isn't going to be safely operated, so we 14 have to set that aside. But in my preparation for the 15 mandatory hearing today on the construction permit I 16 couldn't help but think that if any of the SHINE 17 witnesses are fans of Monty Python, it's the opportunity 18 to say "And now for something completely different." So, 19 the Chairman has made reference to the fact that we've 20 been looking a lot at power reactor mandatory hearings, 21 so this was a chance to wrap our minds around something 22 that is very different.

23 It's commendable for the NRC Staff, and 24 I'll make this point in their overview presentation.

25 They've used what I call an adaptive process, meaning NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

43 1 there was no part of the Code of Federal Regulations that 2 SHINE or the NRC Staff could turn to and say oh, for this 3 type of medical isotope production, here is the 4 regulatory framework. So, as you look forward there are 5 elements of your design that are not complete, there is 6 a research and development program and plans that you 7 have to close on technical uncertainties that the NRC 8 Staff has, of course, reviewed. And that is part of their 9 finding is to see that you have plans and programs in 10 place to complete and answer questions about areas of 11 technical uncertainty.

12 But would SHINE assess -- as the Applicant, 13 do you assess that this adaptive process, a kind of going 14 to things, guidance, regulations that we have in place, 15 deciding which portions of those standing procedures 16 and regulations were or were not relevant to the 17 technology you were proposing, and then applying that 18 and going through a Request for Additional Information 19 process? Would you say that you found that process 20 workable to get through this construction permit stage?

21 And what would you offer in terms of your confidence in 22 continuing to pursue that kind of adaptive process at 23 the operating license stage? And embedded in that, could 24 you address what percent of design do you think you are 25 complete, if you had to put a number on it?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

44 1 MR. PIEFER: So, I think the answer is yes, 2 and I'm going to turn it over to Jim to do a little bit 3 more comments on the process.

4 MR. COSTEDIO: I think the process is very 5 workable. All the way through we've met several times 6 with the Staff, we've had public meetings to work 7 through some of the issues, you know, you talked about 8 that the code doesn't specifically in all cases clearly, 9 I mean, address us, but we were able to work through that 10 during the public meetings with the Staff.

11 COMMISSIONER SVINICKI: Do you see it 12 basically carrying forward into the -- if the 13 construction permit is issued, do you see this same 14 process basically carrying forward in the same form to 15 the operating license phase?

16 MR. COSTEDIO: Absolutely.

17 COMMISSIONER SVINICKI: Okay. And would you 18 say then that in terms of uncertainties for you going 19 forward, you do have certain proof of concept and 20 technical issues that you have plans in place to close 21 on. There's also regulatory uncertainty that exists at 22 some level. Would you say regulatory uncertainty or 23 technical and proof of concept uncertainty, which of 24 those would dominate the uncertainty going forward for 25 you, or perhaps it's financial?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

45 1 MR. COSTEDIO: I would think the regulatory 2 uncertainty.

3 MR. PIEFER: Yes, of those two, I would 4 agree. I think the -- we've done enough technology 5 demonstrations at this point, including a recent demo 6 where General Electric made injectable drugs out of our 7 process, and they looked beautiful. So, we feel pretty 8 confident in the technology at this point. There's a few 9 things outstanding in terms of longevity of the plant, 10 et cetera, that are being worked on as we go forward; 11 corrosion studies, for example, that we're going to be 12 interested in finding out the data there. But, you know, 13 timeline and financing, you know, you mentioned 14 financing uncertainty. Those two are tied hand and hand, 15 and so that's another thing, we're in a hurry. We've got 16 to do it right, but obviously given the exit of the 17 reactors we'd like to move as quickly as possible. And 18 up until now, you know, we've been able to move this 19 project forward in a largely serial fashion, which is 20 eliminate risks, perceived risks from investors, and 21 then move forward and get the next slug of money.

22 COMMISSIONER SVINICKI: Can I ask on that 23 point, the draft construction permit, or the 24 construction permit if issued includes a date by which 25 construction would complete. Do you have a notional time NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

46 1 frame by which you anticipate beginning construction?

2 In a non-proprietary basis, is that something you could 3 share in this open meeting?

4 MR. PIEFER: Yes, I think so. I mean, what 5 does the schedule currently say?

6 MR. COSTEDIO: Spring of 2017.

7 MR. PIEFER: Spring of 2017.

8 MR. COSTEDIO: And we would follow with the 9 OL application about three months later.

10 COMMISSIONER SVINICKI: Okay. And then the 11 last question I had was, I'm not familiar, though, with 12 the airport facility that would be your nearest 13 facility. Is that a cargo hub, or is it -- what size of 14 aircraft -- how active is that facility? Would you have 15 dedicated flights out of there?

16 MR. HENNESSY: We might have dedicated 17 flights out of there. That's certainly one thing we're 18 considering, using a carrier that would provide service 19 from that area.

20 COMMISSIONER SVINICKI: Is the airport 21 facility currently adequately sized for your projected 22 needs, or are there upgrades to the airport itself?

23 MR. HENNESSY: It would be sized for our 24 needs, yes.

25 COMMISSIONER SVINICKI: Okay.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

47 1 MR. PIEFER: It's not used for much other 2 than recreational flying.

3 COMMISSIONER SVINICKI: I was surprised, 4 frankly, again it was a long time ago, but having lived 5 in an adjacent county, I was surprised that there even 6 was an air facility there. I didn't recall that. Okay, 7 thank you for that. Thank you, Mr. Chairman.

8 CHAIRMAN BURNS: Thank you, Commissioner.

9 Commissioner Ostendorff.

10 COMMISSIONER OSTENDORFF: Thank you, 11 Chairman. Thank you all for your presentations this 12 morning.

13 I appreciate that my colleagues have 14 already highlighted that this is a very different type 15 of hearing than we've had under our Part 52 hearings, 16 so having that philosophical mind set change by your 17 comments was very helpful there, Chairman and 18 Commissioner Svinicki.

19 I guess this is a question. I think that 20 Commissioner Svinicki may have asked this, I may have 21 missed the answer, but a question that came up about the 22 overall characterization of design completion. What can 23 you say about that?

24 MR. HENNESSY: I'll take that question. We 25 debate this amongst ourselves quite a bit, as you can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

48 1 imagine. The characterization of design complete is 2 variable depending on the systems you're looking at.

3 Some systems are pretty far along like our tritium 4 purification system, and others are still back at 5 conceptual. Where those systems we know we can fill in 6 quickly with, design what we need to, like HVAC. So, 7 overall, I would say the percent design complete is 8 around 15 percent, which I believe is appropriate for 9 being able to say that we've completed preliminary 10 design.

11 COMMISSIONER OSTENDORFF: Okay. So, let me 12 just stay with you there for a minute on the design 13 piece. I appreciate there's first-of-a-kind 14 engineering issues here, there's some things that have 15 not been attempted before. What are the top two or three 16 areas, sub-components, is it the TSV, is it the hot super 17 cell? I'm curious as to where do you see the most 18 difficult challenges ahead on the design completion?

19 MR. HENNESSY: We have prototypes built in 20 our lab in Monona, and we're continuing to evolve the 21 TSV design, and the TOGS design, and doing testing on 22 components. And I think that's going on pretty well. I 23 think Eric can comment on that some more.

24 COMMISSIONER OSTENDORFF: As you answer 25 this question, can you please maybe give a little more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

49 1 detail on what you have in the form of prototype, 2 mockups, or simulations?

3 MR. HENNESSY: Sure. I'll turn that over to 4 Eric.

5 MR. VAN ABEL: Yes. We have -- each of these 6 components in that overall process diagram, each of 7 those components has been demonstrated individually 8 either by SHINE, by Phoenix Nuclear Laboratories who's 9 the accelerator provider, or by the National 10 Laboratories. You know, the TSV off-gas system, the one 11 that recombines the hydrogen, that system we have a 12 full-scale prototype in our facility in Monona where 13 we've demonstrated full-scale hydrogen recombination 14 testing flow rates, droplet pickup, various things of 15 engineering interest. We have a tritium purification 16 system prototype in our Monona facility constructed by 17 Savannah River National Lab. We have an accelerator in 18 the Monona facility that we share with Phoenix Nuclear 19 Labs that's demonstrated the full production scale 20 accelerator technology. The TSV, we have a mockup TSV.

21 We can't, obviously, put uranium solution in it, but we 22 have a mockup TSV demonstrating -- that's connected to 23 the TOGS system to demonstrate that that system combined 24 performance. And then Argonne National Laboratory is 25 doing experiments on the extraction and purification of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

50 1 our solution, so they've irradiated what they call a 2 mini-SHINE experiment, which is essentially a system 3 very similar to ours from a chemical standpoint of 4 uranyl sulfate solution irradiated by an accelerator.

5 They process it through our same extraction 6 technologies, our same purification technologies that 7 we plan to use. And as Greg mentioned before, they've 8 shipped product to one of our expected customers and 9 demonstrated that it met the purity specifications that 10 we plan to meet.

11 COMMISSIONER OSTENDORFF: If you had to draw 12 a comparison between your preliminary design for the 13 SHINE facility and some existing facilities, 14 irrespective of location, are there a couple of 15 facilities that you think you've borrowed from -- I'm 16 not talking about from an intellectual property 17 standpoint, but just as far as known processes or 18 procedures? I'm trying to figure out what's the analogy, 19 if there are any analogies, as to what other existing 20 facilities might be somewhat comparable in some aspects 21 to yours?

22 MR. VAN ABEL: Yes. So, for the TSV, this is 23 a subcritical assembly, it doesn't go critical, but it 24 shares a lot of the physics and thermal-hydraulic 25 characteristics of aqueous homogenous reactors, AHRs.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

51 1 Those have been built and tested at several facilities.

2 The SUPO reactor at Los Alamos National Lab is one we 3 use a lot for validation. SILENE reactor, the homogenous 4 reactor experiment done at Oak Ridge, HRE reactor. All 5 these facilities we are using their operational 6 history, transient analysis from them to validate our 7 codes to ensure that our codes adequately predict the 8 TSV behavior. Working with Los Alamos National Lab on 9 that, so we borrowed, essentially, how they ran their 10 facilities and operated those AHRs really to feed the 11 design of the TSV.

12 The accelerator, as we mentioned, we have 13 a full-scale prototype of that accelerator already. And 14 the LEU modified Cintichem process that we use for 15 purification, that's based -- that originated at the 16 Cintichem facility, which is an NRC -- previously 17 NRC-licensed facility that produced moly-99 for 18 commercial sale. There they used a typical solid fuel 19 reactor to irradiate solid targets, but then they 20 dissolved them, and processed them, and purified them 21 similar to our technology, so we've looked at that 22 Cintichem facility and use that technology in our 23 facility, as well, for the processing side.

24 COMMISSIONER OSTENDORFF: Thank you. That 25 was very helpful. Thank you, Chairman.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

52 1 CHAIRMAN BURNS: Thank you, Commissioner.

2 Commissioner Baran.

3 COMMISSIONER BARAN: Welcome. Thanks for 4 being here, and for your presentations.

5 Following up on this distinction between 6 the construction permit application and the operating 7 license application, I'm interested in hearing a little 8 bit about how you decided what level of information to 9 include in the construction permit application. When 10 drafting the application, how did you weigh the benefits 11 of having more issues reviewed by the Staff early in the 12 process against having more flexibility during 13 construction, if you were to receive a construction 14 permit?

15 MR. COSTEDIO: Well, we provided the 16 principal design criteria, and the design basis of the 17 structure, systems, and components. From that we were 18 able to do our accident analysis, and the results of the 19 accident analysis shows we're within regulatory limits, 20 within the Part 20 limits. Our definition of 21 safety-related implements those requirements on 10 CFR 22 20 and Part 70.61 for the performance requirements. So, 23 you know, we believe that we've provided the necessary 24 information to obtain the construction permit.

25 COMMISSIONER BARAN: In the final ACRS NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

53 1 letter to the Commission, the ACRS raised seven topics 2 to be further addressed in the application for an 3 operating license. Pre-hearing Question 4, explored 4 this issue, and your response indicated that these 5 topics are not included as commitments in Appendix A of 6 the Safety Evaluation Report. How will SHINE ensure that 7 the ACRS topics will be addressed at the operating 8 license stage?

9 MR. COSTEDIO: All of those topics are 10 included -- we issue what we call Issue Management 11 Reports, which are contained in our Corrective Action 12 Program. And every one of them is being tracked to be 13 included in the operating license application.

14 COMMISSIONER BARAN: Okay, thank you.

15 Although the SHINE facility is not a 16 reactor, part of the licensing basis for the 17 construction permit utilizes design principles from the 18 general design criteria for nuclear power plants. Can 19 you clarify the process you used to determine which 20 general design criteria are applicable to the SHINE 21 facility?

22 MR. HENNESSY: We reviewed all of the 23 general design criteria as outlined in our PSAR when we 24 were looking at the preliminary design, and the PSAR 25 also contains a description of how each of those GDC NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

54 1 would apply to SHINE, or how it's integrated into our 2 design, so we actually reviewed all of them.

3 COMMISSIONER BARAN: Okay. So, you went 4 through them all systematically and assessed whether 5 each one would apply in concept at least to this 6 facility.

7 MR. HENNESSY: Yes.

8 COMMISSIONER BARAN: Okay, thank you. Thank 9 you, Mr. Chairman.

10 CHAIRMAN BURNS: Thank you, Commissioner.

11 I want to thank the Applicant's panel for 12 their presentations. We'll now proceed with the 13 Overview Panel from the NRC Staff. I'll ask the 14 witnesses please come forward, yes.

15 Okay. Again, this will be the Overview 16 Panel, or an overview from the Staff Panel with respect 17 to the application. I'm going to remind the witnesses 18 you're under oath, and did you all take the oath?

19 WITNESSES: Yes, sir.

20 CHAIRMAN BURNS: Okay. And, again, assume 21 that the Commission is familiar, generally familiar 22 with the pre-hearing filings from the Staff and the 23 Applicant. And I will ask the panelists to introduce 24 themselves. Ms. Gavrilas.

25 MS. GAVRILAS: Mirela Gavrilas, Division of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

55 1 Policy and Rulemaking in NRR.

2 MS. MARSHALL: Jane Marshall. I'm the Deputy 3 Director for the Division of License Renewal in NRR.

4 MR. DEAN: Bill Dean, Director of Office of 5 Nuclear Reactor Regulation.

6 MS. BAILEY: Marissa Bailey. I'm the 7 Director for the Division of Fuel Cycle Safety 8 Safeguards and Environmental Review in NMSS.

9 CHAIRMAN BURNS: Okay, thank you. And let 10 the Staff proceed.

11 MR. DEAN: Okay. Good morning, Chairman, 12 Commissioners. We're pleased to be here with you this 13 morning to provide testimony associated with the 14 application for a construction permit submitted by 15 SHINE Medical Technologies for a medical radioisotope 16 irradiation and production facility.

17 What you'll hear from this panel is an 18 overview of the Staff's review methodology, as well as 19 highlighting some of the technical and environmental 20 review aspects of it. Essentially, we'll be setting the 21 stage for the panels that you'll have later today on both 22 the technical and environmental aspects of the review.

23 Could I have the next slide, please.

24 So, I'm not going to spend much time on this 25 slide. I think the SHINE representatives did a very good NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

56 1 job in terms of setting the stage for the importance of 2 moly-99 production, benefits of the technetium-99 3 metastable as an important radioisotope for medical 4 diagnostic procedures. I think they also set the stage 5 in terms of how much this radioisotope is used in both 6 the United States and globally, so I think they set a 7 pretty good stage for why it's important that we pursue 8 domestic supply, particularly with the Canadian 9 facility scheduled to shut down in 2018, as well as the 10 challenges that have existed at some of the foreign 11 facilities with interruptions in supply because of 12 extensive shutdowns for maintenance activities and so 13 on. So, I think we have a pretty good case for why it's 14 important domestically that we have a moly-99 15 production facility. Next slide, please.

16 So, national policy objectives which 17 support domestic production capabilities really have 18 three major components to them. One is to assure that 19 we have a reliable source of moly-99 production.

20 Secondly, that it's not utilizing highly enriched 21 uranium in producing the moly-99, as well as no market 22 subsidies. Those are three aspects of the national 23 objectives associated with moly-99 production 24 domestically.

25 We have -- DOE's National Security NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

57 1 Administration has engaged in cost-sharing agreements 2 with various organizations, and SHINE Medical 3 Technologies is one of those in terms of helping to 4 develop moly-99 production capability. As the SHINE 5 representatives noted, they plan on utilizing a uranium 6 fission process utilizing low enriched uranium in an 7 aqueous homogeneous reactor, and then chemically 8 separating the moly-99 in a radioisotope production 9 facility.

10 I think the important thing here is that 11 from a Staff perspective, our review is consistent with 12 the national policy, and conforms with the Atomic Energy 13 Act, and all the applicable regulations. Next slide, 14 please.

15 We've been preparing for the SHINE review, 16 and actually review of any medical radioisotope 17 facility for some time. Back in 2009, we formed an 18 interoffice working group that contributed substantial 19 technical and regulatory diversity and expertise in 20 terms of developing approaches that we would consider 21 if and when we got a production facility application.

22 Back in 2012, we created a Interim Staff 23 Guidance document that was specifically focused on 24 aqueous homogeneous reactors to support and supplement 25 the SRP or the Standard Review Plan for research and test NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

58 1 reactors. And this is the products that the SHINE 2 facilities have utilized in terms of developing their 3 construction application.

4 We've had a number of public meetings with 5 engaged stakeholders. This includes, obviously, the 6 SHINE management and staff, public individuals, as well 7 as federal, state, and local governments. These 8 meetings have been focused on the technical, the 9 regulatory, and the environmental review aspects of the 10 SHINE facility. We also have coordinated our review with 11 federal, state, and local governments. So, for example, 12 NNSA from DOE has been involved, the Environmental 13 Protection Agency, the National Fish and Wildlife 14 Foundation, and the Advisory Council on Historical 15 Preservation. And at the state and local levels, the 16 State of Wisconsin Department of Health Services, and 17 the Janesville City Council has been significantly 18 involved with us in terms of some of the review aspects.

19 Next slide, please.

20 So, at this point I'd like to turn it over 21 to Mirela who will discuss the Staff's review of the 22 SHINE construction permit.

23 MS. GAVRILAS: Thank you, Bill.

24 In 2013, SHINE submitted a two-part 25 application for a construction permit under 10 CFR Part NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

59 1 50. If granted, the permit will allow SHINE to construct 2 a medical radioisotope production facility in 3 Janesville, Wisconsin. SHINE's application only seeks 4 authorization to construct the proposed SHINE facility; 5 therefore, the 10 CFR Part 50 regulations require less 6 detail than for an operating license or a Combined 7 License application.

8 The necessary elements of a construction 9 permit application are provided in Section 50.34 and 10 include a preliminary design of the facility, a 11 preliminary analysis of structures, systems, and 12 components, probable subjects of technical 13 specifications, a preliminary emergency plan, a quality 14 assurance program, and ongoing research and 15 development.

16 SHINE will submit the Final Safety Analysis 17 Report, or FSAR, with their operating license. The FSAR 18 will include SHINE's final design, plans for operation, 19 emergency plan, technical specification, and physical 20 security plan. Next slide, please.

21 The Staff's evaluation of SHINE's 22 construction permit application consisted of two 23 concurrent reviews. One, of SHINE's Preliminary Safety 24 Analysis Report, or PSAR, and the other of SHINE's 25 environmental report. I will discuss the Staff's safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

60 1 review, and Jane Marshall will discuss the Staff's 2 environmental review.

3 The Staff's safety review assessed the 4 sufficiency of the preliminary design. This includes 5 the principal design criteria and the design basis of 6 SHINE's proposed medical radioisotope facility. The 7 SHINE facility consists of an irradiation facility, or 8 IF, and a Radioisotope Production Facility, or RPF. Next 9 slide, please.

10 From the Staff's perspective, SHINE's 11 irradiation facility and radioisotope production 12 facility rely on novel and unique technology.

13 Therefore, the Staff tailored its activities and 14 coordinated with offices throughout the Agency to 15 ensure an informed and efficient review.

16 SHINE's irradiation facility consists of 17 eight subcritical operating assemblies or irradiation 18 units. Each irradiation unit is a 10 CFR Part 50 19 utilization facility. While not reactors, irradiation 20 units are similar to research reactors.

21 SHINE's proposed radioisotope production 22 facility consists of three super cells for the 23 separation of molybdenum-99 from irradiated target 24 solution. The RFP is a 10 CFR Part 50 production 25 facility. However, the RFP has physical and chemical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

61 1 processes similar to existing fuel cycle facilities.

2 For both the irradiation facility and the radioisotope 3 production facility, the Staff used the Commission's 4 regulations and existing guidance to determine 5 acceptance criteria that demonstrate compliance with 6 regulatory requirements.

7 The Staff's safety evaluation for both the 8 irradiation facility and the radioisotope production 9 facility was informed primarily by NUREG-1537 which is 10 the Standard Review Plan for research and test reactors.

11 The Staff augmented NUREG-1537 with Interim Staff 12 Guidance or ISG for evaluating aqueous homogenous 13 systems and production facilities. The Staff also 14 assessed the preliminary design to have reasonable 15 assurance that SHINE's final design will conform to the 16 design basis. Next slide, please.

17 An important part of the Staff's review was 18 to determine what additional technical and design 19 information beyond SHINE's initial PSAR was necessary 20 to support the evaluation of the construction permit 21 application. The Staff issued Requests for Additional 22 Information and SHINE supplemented its application.

23 After reviewing the application as 24 supplemented, the Staff found that SHINE provided all 25 the information necessary for the Staff to complete its NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

62 1 safety review for the purposes of issuing a construction 2 permit. However, the Staff identified certain areas 3 where additional information is required before 4 construction is complete. The Staff is, thus, 5 recommending construction permit conditions.

6 The conditions require SHINE to provide 7 periodic updates on the design of certain features 8 related to criticality safety and radiation protection.

9 These updates are consistent with 10 CFR 50.35. They 10 are intended to confirm that SHINE's final design will 11 conform to the PSAR design basis. For example, SHINE has 12 proposed a criticality alarm system in the radioisotope 13 production facility. A shielding wall will surround the 14 criticality alarm system. The Staff believes that 15 before construction is complete, SHINE must establish 16 the appropriate shielding wall thickness because if the 17 shielding is too thick, the alarm system will not 18 perform as required. If the shielding is too thin, 19 radiation protection will become a concern.

20 In instances where additional information 21 may reasonably be left for later consideration, SHINE 22 has made commitments to provide such information in the 23 FSAR. These commitments are listed in Appendix A of the 24 Safety Evaluation Report, or SER. The Staff will verify 25 that necessary information has been provided during the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

63 1 review of SHINE's operating license application.

2 The Staff's SER also initially proposed 3 conditions related to the Preliminary Amendment Request 4 process. However, as noted in our answers to pre-hearing 5 questions, the Staff has determined that this process 6 is better suited for construction based on a final 7 facility design. As such, the Staff no longer recommends 8 these conditions. The Staff finds that the existing 9 regulations in 10 CFR 50 are sufficient to accommodate 10 changes to the SHINE facility as the design matures.

11 Next slide, please.

12 I will now turn over the presentation to 13 Jane Marshall for an overview of the SHINE environmental 14 review.

15 MS. MARSHALL: Thank you, Mirela.

16 The environmental review for the SHINE 17 construction permit application was performed in 18 accordance with the National Environmental Policy Act 19 of 1969, commonly referred to as NEPA. NEPA established 20 a national policy for considering environmental impacts 21 and requires federal agencies to follow a systematic 22 approach in evaluating potential impacts, and to assess 23 alternatives to the proposed action. The NEPA process 24 also involves public participation and public 25 disclosure.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

64 1 10 CFR Part 51 contains NRC's environmental 2 regulations which implement NEPA. These regulations 3 describe when the Staff should prepare an Environmental 4 Impact Statement or EIS. The NRC's regulations did not 5 require the preparation of an EIS for SHINE's 6 application; however, the Staff determined that an EIS 7 would be appropriate because SHINE is a first-of-a-kind 8 application for medical radioisotope production 9 facility with a unique application of technologies and 10 an EIS would allow several opportunities for public 11 involvement in the environmental review process.

12 Ultimately, the purpose of the 13 environmental review is to identify the environmental 14 impacts of constructing, operating, and 15 decommissioning the proposed SHINE facility, as well as 16 alternatives to the SHINE facility, and in combination 17 with the safety review, inform the Staff's 18 recommendation to the Commission whether or not to issue 19 the construction permit. Next slide, please.

20 The Staff began the environmental review 21 with a scoping process to gather input from the public, 22 other government agencies, and tribes on the necessary 23 scope for the EIS. The Staff conducted an Environmental 24 Site Audit to view the environmental features at the 25 proposed site and the alternative sites, and met with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

65 1 SHINE's technical specialists that developed the 2 environmental report. The Staff also developed Requests 3 for Additional Information to clarify aspects of 4 SHINE's environmental report and to seek additional 5 information not included in SHINE's environmental 6 report.

7 The Staff developed a Draft EIS based on the 8 Staff's independent review, information in the 9 environmental report, answers to the Staff's Request 10 for Additional Information, and input received during 11 the scoping process and Environmental Site Audit. The 12 Draft EIS was published for comment in May of 2015. The 13 Staff responded to all comments received in the Final 14 EIS which was published in October 2015. The Staff also 15 updated the Final EIS based on in-scope comments and 16 newly available information. Next slide, please.

17 The proposed site is currently an 18 agricultural field which has been previously disturbed 19 from decades of agricultural activities, and is 20 currently zoned for light industrial use. The proposed 21 site does not contain any surface water features, 22 threatened or endangered or candidate species, or 23 historical or cultural resources. The Staff determined 24 that the impacts to all resource areas, except for 25 traffic, would be small. The impacts to traffic would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

66 1 be small to moderate because of the noticeable increase 2 in average daily traffic flow. Next slide, please.

3 I will now turn the presentation over to 4 Marissa Bailey to discuss the Staff's regulatory 5 findings supporting its recommendation that SHINE be 6 issued a construction permit.

7 MS. BAILEY: Thank you, Jane. And I'm on 8 Slide 13, and as Jane mentioned, I'll be discussing the 9 Staff's findings to support issuance of a construction 10 permit.

11 Section 103 of the Atomic Energy Act 12 authorizes the Commission to issue licenses to 13 utilization and production facilities subject to the 14 Commission's regulations. The principal regulatory 15 requirements for utilization and production facilities 16 are in 10 CFR Part 50.

17 After completing the environmental and 18 safety reviews, the Staff has determined that SHINE's 19 application met the applicable requirements of 10 CFR 20 Parts 20, 50, and 51. Also, because processes and 21 hazards are similar to fuel cycle facilities, the Staff 22 determined the performance requirements in 10 CFR 70.61 23 can be used to demonstrate adequate safety for the 24 radioisotope production facility. Slide 14, please.

25 The Staff's review supports the four NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

67 1 findings in 10 CFR 50.35 for issuance of a construction 2 permit. The first finding is that the Applicant has 3 described the proposed design of the facility. The Staff 4 used 10 CFR 50.34(a) and our guidance to evaluate the 5 sufficiency of the preliminary design making sure that 6 SHINE's proposed design basis and criteria are 7 consistent with policy regulations and guidance.

8 SHINE committed to design the facility to 9 meet the operational safety requirements in 10 CFR Part 10 20, and the accident consequence and likelihood 11 criteria in the Interim Staff Guidance augmenting 12 NUREG-1537. SHINE designated safety-related 13 structures, systems, and components that will be 14 provided for the protection of the health and safety of 15 the public.

16 The second finding is that the Applicant 17 has identified technical or design information that can 18 be reasonably left for the Final Safety Analysis Report.

19 The Preliminary Safety Analysis Report identified such 20 information. This includes the security and safety 21 emergency plans, facility operating procedures, and 22 certain design information that SHINE committed to 23 provide in the Final Safety Analysis Report.

24 The third finding is that the Applicant has 25 identified safety features that required further NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

68 1 research and development, and SHINE has done that. SHINE 2 has ongoing research and development activities related 3 to irradiation and corrosion testing, and precipitation 4 studies. These tests are being performed by Oak Ridge 5 and Argonne National Laboratories respectively.

6 The fourth finding is, one, for those 7 safety questions and SHINE's research programs, Staff 8 has reasonable assurance that SHINE will be able to 9 complete the research programs before the latest date 10 of construction. And, two, taking into consideration 11 the site criteria contained in 10 CFR Part 100, the 12 proposed facility can be constructed and operated 13 without undue risk to the public. And with respect to 14 that fourth finding, SHINE has stated that the latest 15 date of their construction would be December 31, 2022.

16 Based on the schedule SHINE has given us, we're 17 expecting that the research programs will be completed 18 before this date. Also, the additional permit 19 conditions related to criticality safety and radiation 20 safety must be satisfied before the completion of 21 construction.

22 The site criteria in Part 100 applied to 23 power reactors and testing facilities, and not to 24 SHINE's, but the Staff considered similar site-specific 25 conditions and external events. The Staff's review NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

69 1 confirmed that the radiological releases during normal 2 and abnormal conditions will be within the 10 CFR Part 3 20 dose limits. Thus, we find that the proposed facility 4 can be constructed and operated at the proposed location 5 without undue risk to the health and safety of the 6 public.

7 Additionally, the Staff concludes that for 8 the purpose of issuing a construction permit, it 9 conducted a thorough and complete environmental review 10 sufficient to meet the requirements of NEPA and adequate 11 to inform the Commission's action on the construction 12 permit request. Slide 15, please.

13 Based on these findings, the Staff 14 concludes that there is sufficient information for the 15 Commission to issue the subject construction permit to 16 SHINE as guided by the following considerations in 10 17 CFR 50.40 and 50.50. First, there is reasonable 18 assurance that the construction of the SHINE facility 19 will not endanger the health and safety of the public, 20 and that construction activities can be conducted in 21 compliance with the Commission's regulations.

22 Second, SHINE is technically and 23 financially qualified to engage in the construction of 24 its proposed facility. Third, the issuance of a 25 construction permit for the facility would not be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

70 1 inimical to the common defense and security, or to the 2 health and safety of the public. Fourth, after weighing 3 the environmental, economic, technical and other 4 benefits of the facility against environmental and 5 other costs and considering reasonable available 6 alternatives, the issuance of this construction permit 7 is in accordance with Subpart A of 10 CFR Part 51, and 8 all applicable requirements have been satisfied. And 9 fifth, the application meets the standards and 10 requirements of the Atomic Energy Act and the 11 Commission's regulations, and that notifications to 12 other agencies or bodies have been duly made. Slide 16, 13 please.

14 The Staff will discuss novel aspects of its 15 review of the SHINE construction permit application.

16 Safety Panel 1 will discuss the unique licensing 17 considerations. Safety Panel 2 will follow with details 18 of the Staff's accident analysis. And, finally, the 19 Environmental Panel will provide a summary of the 20 process for developing the Environmental Impact 21 Statement.

22 This concludes the Staff's remarks in the 23 Overview Panel. We're prepared to respond to any 24 questions you may have at this time. Thank you.

25 CHAIRMAN BURNS: Okay. I want to thank the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

71 1 Staff Panel. We'll begin this round of questioning with 2 Commissioner Svinicki.

3 COMMISSIONER SVINICKI: Well, good morning, 4 and thank you to the NRC Staff witnesses, and all the 5 NRC Staff that contributed to the review which is the 6 topic of our evaluation and consideration here today.

7 I should have been born in Missouri, I 8 guess, because I'm the kind of person that I don't really 9 judge things by what people tell me they're capable of, 10 or what they say they plan to do, but what they actually 11 perform, how they actually perform, and what they 12 actually do. You know, the Chairman was talking in his 13 opening remarks about some of the significant licensing 14 work that the NRC Staff has undertaken this year. We've 15 had a number of mandatory hearings, and there are many 16 tens of thousands of NRC Staff hours that go into that 17 review, not just licensing staff, but legal, and a lot 18 of other support organizations support that work.

19 I think if we look at, in particular, Watts 20 Bar 2 operating license and in the Staff's work in 21 support of the findings they've made for issuance of 22 this construction permit, an interesting thing has 23 happened. And, again, I -- you know, these days with the 24 news such as it is, I'll turn over every rock and look 25 for some good news, so you can fault me for that, if you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

72 1 want. But there are many questions being asked about the 2 NRC's potential readiness to look at novel reactor 3 technologies. And I think if we looked at the kind of 4 work and adaptation and agility that had to be 5 demonstrated in the Watts Bar 2 history which had a very 6 unique history in terms of the run-up, the many decades 7 run-up to the issuance of that operating license. And 8 then if we complement that with the Staff's work here 9 in looking at the SHINE construction permit 10 application, but ultimately, also, you're looking 11 forward towards the operating phase and making the 12 safety and environmental determinations that you will 13 need to make there.

14 I think it demonstrates to those skeptical, 15 or maybe those who feel that the NRC's approach and 16 regulations and guidance indicates a very linear and 17 rigid approach to licensing new and novel things. I 18 think both of those licensing activities demonstrated 19 significant ability to take a regulatory framework, 20 existing guidance, maybe complemented by some new 21 Interim Staff Guidance and take that and kind of wrap 22 it around the thing that's in front of you and say what 23 are the relevant and appropriate parts, and how do we 24 do that? And, often, you haven't taken years and years 25 worth of trying to develop the little bits that you need NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

73 1 to augment support.

2 Mr. Dean did mention that the Staff has been 3 preparing itself for a medical isotope application, but 4 the truth of the matter is, it could have taken a lot 5 of different forms. There's -- it could have been vastly 6 different, so what the Staff needed to have in place is 7 something that they could innovate and adapt, and tailor 8 to the thing in front of it. And I think, at least to 9 this stage of the process, and there are quite a few 10 issues, might get a little tricker in the operating 11 license phase because you've got to come to finality on 12 some complex issues. But that being said, the reason I 13 asked the Applicant in the Overview Panel about getting 14 some calibration on their view of regulatory 15 uncertainty is that when you're inside NRC, you often 16 walk around -- we walk around with greater familiarity, 17 perhaps, with the regulatory system, but maybe as a 18 result, a greater confidence in the ability to on our 19 feet do adaptation and innovation, and tailor that 20 particular regulatory framework to whatever is 21 presented to us for review and approval. And I think that 22 we've done that here.

23 So, having asked the Applicant how did this 24 adaptive process work from their standpoint, I think I 25 got a fairly positive response on that. How would the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

74 1 Staff answer that same question? Do you think that this 2 taking the existing regulatory framework guidance and 3 then adapting it, determining relevance of various 4 provisions within the framework, do you think that that 5 worked well to this stage, and is your confidence high 6 that that will continue through the remainder of the 7 review? Again, where you will be required to meet the 8 higher bar of coming to closure and finality on some open 9 issues that right now you can, in essence, to use a bad 10 word, punt those off to the operating license stage.

11 MR. DEAN: So, thank you for the remarks, 12 Commissioner. And I would agree with you, I think the 13 Staff has shown a high degree of flexibility and agility 14 in terms of how they have managed this review activity.

15 I think one of the important things for us, 16 and maybe Mirela can add something to this, is having 17 a sense of commitment on the part of the Applicant, so 18 that it was worthwhile to invest what we needed to do 19 in order to be at the stage that we're at to be able to 20 conduct the review. I think having some predictability 21 and confidence in that certainly helps us move forward 22 in a way that would allow us to apply all the resources 23 that we did. For example, to develop the ISG on the 24 aqueous homogenous reactor, I think was an important 25 development given the fact that we had confidence that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

75 1 there would be something coming forward from SHINE.

2 Mirela, do you have anything to add?

3 MS. GAVRILAS: Yes. I can add to that, and 4 I certainly agree what Bill said, that having the 5 interactions with SHINE throughout the process through 6 public meeting was very helpful. But getting back to 7 your original statement, indeed, the Staff does have 8 some confidence in the regulatory framework, and that 9 starts with we know that Part 50 is applicable to 10 irradiation facilities and to production facilities. We 11 know that the irradiation facilities, while they're 12 indeed novel to us, they look like our research 13 reactors, and we have experience with a spectrum of 14 research reactors that exhibit a lot of variability. We 15 have experience with -- I think just before this meeting 16 I was told 12 homogeneous aqueous research reactors, so 17 even there we have the experience necessary.

18 On the side of the production facility, we 19 have experience with Cintichem. Granted, that was under 20 Part 70, but we have the West Valley facility that was 21 actually licensed under Part 50. So, what the Staff did 22 is, we took the guidance that we had for these -- for 23 research and test reactor, the NUREG-1537 which is our 24 Standard Review Plan, augmented it with ISG that 25 captured liquid homogeneous reactors, and the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

76 1 production facilities and came up with a framework that 2 was suitable for SHINE.

3 COMMISSIONER SVINICKI: To build on that, 4 and this is my final question. Maybe this will be a 5 little tricky, so bear with me. Would the Staff assert 6 that the decisions that you've made to this point on 7 which portions and provisions within those portions of 8 our regulations are relevant to your review of this 9 technology on the safety side? Are those determinations 10 final, or subject to change? I guess what I'm asking is, 11 as you move towards closure in areas that you or the ACRS 12 have suggested bear additional work, criticality comes 13 to mind, other things where we have to adapt the 14 framework to the highly novel aspects of what we're 15 looking at and make a final safety determination. Do you 16 think you might determine that some section of the CFR 17 that you previously just weren't even engaging with the 18 Applicant on, you might suddenly go, you know, we didn't 19 really look there earlier, but based on the path that 20 this technical issue is taking, we now think that some 21 new provision of the regulation, you're going to have 22 to demonstrate that you meet some requirement there. Do 23 you think that that's likely or unlikely?

24 MS. GAVRILAS: I can try to answer that, and 25 maybe I'll need help on that. So, for the construction NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

77 1 permit we feel we're done, so basically there's nothing 2 that is needed. Looking forward to the operating 3 license, that's going to be our first priority, to look 4 at the regulations and see what, if anything, will need 5 to be adapted, be it by rulemaking, by order, licensing 6 conditions. We're going to think what's best for the 7 framework to be able to accommodate the operating 8 license review. And we already know that there are some 9 things that impact moly production facilities. For 10 example, the work on material characterization under 11 74, the rulemaking there is going to be relevant to moly 12 producers. There's security work under Part 73 that's 13 going to be relevant to them. We know that we'll need 14 to look closely at operator licensing because operators 15 might be needed not just for the utilization facility, 16 but also for the production facility, so we'll need to 17 scrutinize the regulation. So, we know we have some work 18 to do going forward.

19 As far as your question for the technology, 20 we haven't necessarily seen something in the regulation 21 that might need to be changed. It's more the 22 administrative procedural, not the technology itself 23 that is worrying us right now going forward.

24 COMMISSIONER SVINICKI: I need to ask a 25 follow-up based on that answer. Thank you for that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

78 1 answer.

2 If we look at the broad purposes of why an 3 agency such as ours reviews and issues a construction 4 permit, there is an element of wanting to identify 5 issues so that irreversible or very difficult to reverse 6 decisions are not made in the construction of the 7 facility; that, you know, you want some sense of, if 8 constructed in accordance with the construction permit 9 that we would issue, there would be high confidence that 10 if other issues are resolved you could operate that 11 facility at some point without needing to chip out a 12 4-foot thick concrete wall and make fundamental 13 changes. So, what is the Staff's level of confidence in 14 terms of the identification of relevant regulations 15 that you just described in your previous answer? Do you 16 think that that lends additional uncertainty going 17 forward to the probability of successful issuance of an 18 operating license in terms of physical rework of what 19 it is that they're going to construct? I know the 20 potential always exists. I'm not asking you if it's 21 zero. I'm asking you, you know, do you have like at least 22 a reasonable sense of confidence that you've identified 23 issues that have the potential for causing substantial 24 rework?

25 MS. GAVRILAS: So, perhaps what would help NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

79 1 is an example on where we set the bar for what's 2 sufficient for construction permit, as opposed to what 3 the expectation is for an operating license. And the bar 4 was, we heard SHINE speak earlier about hydrogen 5 control. So, hydrogen control is a perfect example, 6 because the physics. In other words, what the 7 concentrations are where deflagration becomes a concern 8 are known. The production rate of hydrogen is known. Our 9 models, we have well established uncertainties in those 10 models. We can bound them.

11 Furthermore, what's also known is 12 mitigation technology for that. For example, passive 13 autocatalytic recombiners, I think SHINE mentioned 14 those, igniters. There's technology to mitigate the 15 broad range of hydrogen production, so we know that. So, 16 the Staff has confidence that going forward that aspect 17 given where the state-of-the-art is in terms of both 18 knowledge and technology, and SHINE's responses to us 19 on what they intend to use, we have confidence that the 20 outstanding technical issues have a reasonable chance 21 of being addressed.

22 COMMISSIONER SVINICKI: Okay. So based on 23 that, is it fair to characterize that the Staff at this 24 stage has not recommended anything in terms of going 25 forward with the construction permit that it would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

80 1 identify as fundamentally unlicensable or unlikely to 2 be able to be operated or licensed at the operating 3 license stage?

4 MS. GAVRILAS: That's fair.

5 COMMISSIONER SVINICKI: Okay, thank you.

6 Thank you, Mr. Chairman.

7 CHAIRMAN BURNS: Thank you, Commissioner.

8 Commissioner Ostendorff.

9 COMMISSIONER OSTENDORFF: Thank you, 10 Chairman. Thank you all for your briefs today, and for 11 the work of you and your teams. It's important work.

12 I want to maybe, Mirela, pick up a little 13 bit with where Commissioner Svinicki was probing with 14 you. From your Slide 8 where you said the Staff used 15 existing guidance -- in the discussions with 16 Commissioner Svinicki and the exchange during her Q &

17 A -- I just want to make sure I understand one thing.

18 I think it is that you did not -- you and your team did 19 not experience any challenges working within our 20 existing regulations with our existing guidance as far 21 as being able to, I'll say, on the fly adapt where 22 judgment would lead one to say this is a reasonable way 23 of handling a particular design issue.

24 MS. GAVRILAS: No, the challenges as I -- in 25 my earlier answer, the challenge is where the bar for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

81 1 construction permit needs to be set relative to what our 2 expectations are in the final design. That was where the 3 Staff needed to exercise its technical judgment. We 4 haven't had areas where we needed to -- where we had 5 significant gaps that we needed to address, if I 6 understood your question correctly. If I didn't --

7 COMMISSIONER OSTENDORFF: Let me rephrase 8 it because I'm not sure -- I may not have asked it as 9 clearly as I should have.

10 Were there flaws or gaps in the existing NRC 11 regulations or guidance that prevented your team from 12 doing their work on the construction permit?

13 MS. GAVRILAS: There was one issue that we 14 had to address, specifically the fact that the 15 irradiation facility was not covered under Part 50 16 because they're subcritical and the definition for 17 irradiation facility --

18 COMMISSIONER OSTENDORFF: I understand. The 19 Commission got involved in that here.

20 MS. GAVRILAS: Yes, that's the only flaw 21 that we found.

22 COMMISSIONER OSTENDORFF: Okay. And you 23 felt like -- working within the existing guidance 24 documents that there was sufficient flexibility for the 25 Staff to be able to exercise reasonable judgment as to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

82 1 how to apply certain sections?

2 MS. GAVRILAS: Yes. And that might be aided 3 by the fact that the existing guidance that we relied 4 upon was primarily NUREG-1537, which is designed for 5 research reactors which do exhibit a fair amount of --

6 COMMISSIONER OSTENDORFF: Okay.

7 MS. GAVRILAS: -- differences.

8 COMMISSIONER OSTENDORFF: Okay. I think 9 this is still a question for you, but others may want 10 to chime in here. The first session with the SHINE panel, 11 I asked a question that was addressed I think by Eric 12 about the use of prototypes by SHINE organization, the 13 reference to other existing reactors, and I think Eric 14 mentioned one from the Los Alamos National Laboratory.

15 Can you talk at a high level about how our Staff perhaps 16 used experience of these prototypes or other existing 17 technologies to consider the construction permit?

18 MS. GAVRILAS: I'm going to ask Steve Lynch 19 who was the Project Manager on SHINE to talk about 20 specifics.

21 CHAIRMAN BURNS: Okay. And, Mr. Lynch, 22 identify yourself for the record, and confirm that you 23 took the oath.

24 MR. LYNCH: Yes. My name is Steve Lynch. I 25 am the Project Manager for SHINE on the NRC Staff. And NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

83 1 yes, I did take the oath.

2 CHAIRMAN BURNS: Okay, proceed.

3 MR. LYNCH: Yes. As far as facilities most 4 we considered on the irradiation facility side were 5 existing research reactors and past experience with 6 aqueous homogeneous reactors. On the production 7 facility side we did look back to our licensing 8 experience with the Cintichem facility. We actually did 9 have on staff former employees from Cintichem that 10 helped inform the development of our guidance and the 11 beginning of our review.

12 COMMISSIONER OSTENDORFF: Can you talk 13 about, Steve, I think Eric had mentioned SHINE's own 14 prototype efforts. Can you talk about how you might have 15 looked at those, or considered those in your review?

16 MR. LYNCH: We have not looked extensively 17 at the prototypes. We have considered some of the papers 18 that have come out from the National Labs describing 19 their results. We will look more carefully at that at 20 the operating license stage.

21 COMMISSIONER OSTENDORFF: Okay, thank you.

22 Jane, I don't want you to go without a 23 question here.

24 MS. MARSHALL: Thank you, sir.

25 COMMISSIONER OSTENDORFF: I'll ask an NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

84 1 environmental review question. And, you know, I think 2 Mirela has mentioned -- my question is what is this 3 like, the environmental review, is this like a research 4 test reactor, or is it like in Marissa's bailiwick the 5 fuel cycle facility? What does the environmental review 6 look like? Is it a hybrid of these, or something else?

7 MS. MARSHALL: It's a hybrid. I guess we're 8 lucky in a sense. All of the environmental regulations 9 are in Part 51, so we didn't have to look beyond that.

10 And as part of the environmental review, we looked at 11 the connected actions so we didn't just look at 12 construction, we looked at operation, decommissioning, 13 traffic flow. So, in that sense it was much like any 14 other environmental impact statement that we would 15 prepare.

16 COMMISSIONER OSTENDORFF: Okay. Anybody 17 else on that? All right, thank you. Thank you all.

18 CHAIRMAN BURNS: Thank you, Commissioner.

19 Commissioner Baran.

20 COMMISSIONER BARAN: Thanks. Well, let me 21 start by thanking you and the rest of the Staff who 22 worked on this application for all the hard work that 23 went not only into preparing for today's hearing, but 24 also all the efforts in reviewing this unique 25 application.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

85 1 I wanted to follow-up on a couple of things 2 I asked about -- asked SHINE about on the first panel.

3 Going back to the ACRS letter and the seven topics that 4 they identified that should be further addressed in an 5 application for an operating license. We talked to SHINE 6 about that. They said those are going to be addressed 7 in their Corrective Action Program. Can you talk a 8 little bit about how the Staff intends to ensure that 9 those issues are addressed in the operating license 10 application?

11 MS. GAVRILAS: Some of the items that came 12 out of the ACRS discussions are actually captured in our 13 SER. They are among the items that we listed in Appendix 14 A. Perhaps it's not the complete list, but we'll make 15 sure that when operating review -- operating license 16 review time comes we will look at the entirety of the 17 items that were mentioned by the ACRS in their letter.

18 There were also commitments that SHINE made 19 explicitly to the ACRS, and those we also captured in 20 the SER in the same Appendix A on the two items that the 21 ACRS had engaged them on, that the Staff had not 22 previously had discussions with them. So, we fully 23 intend to follow-up on all the items raised by the ACRS.

24 COMMISSIONER BARAN: Okay. And just to 25 clarify then for the answers to the pre-hearing question NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

86 1 related to this, some but not all of these items the ACRS 2 identified were captured as commitments on Appendix A, 3 in Appendix A.

4 MS. GAVRILAS: I believe that is the case.

5 We'll check during the lunch break and we'll get back 6 to you at the end of the day, if we need to make a 7 correction on that.

8 COMMISSIONER BARAN: Okay, great. Thanks.

9 And as we've noted at various points, some 10 of the regulations, like the general design criteria, 11 don't apply to SHINE because it's not a reactor. But the 12 Staff considered these regulations when doing its 13 review, and the Applicant considered them in its design.

14 Can you describe that process in a little bit more 15 detail? Would the Staff ask RAIs on concepts from the 16 general design criteria, or were these used as a 17 reference for the technical reviewers? What role did 18 they play?

19 MS. GAVRILAS: So, there's the expectation 20 in 50.34 of providing principal design criteria as 21 unambiguous, so we want that. What SHINE did in their 22 application, they actually came and had crosswalk 23 tables of all the 55 GDCs, how they apply or not apply, 24 or adapt to the features of their facility. So, the Staff 25 scrutinized that and found it acceptable. And I will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

87 1 give an example for containment, GDC-16 deals with 2 containment. They have a confinement, but they adapted 3 the notion of controlled leakage that's intended in 4 GDC-16. So, in addition to the GDCs, they also have the 5 GDCs, as you mentioned, are designed for light water 6 power reactor.

7 They also have a production facility that 8 has unique features. There they proposed safety systems 9 and components that actually lend themselves to 10 additional criteria. I'll give an example, the 11 concentration of uranium in the solution. That will 12 become part of the design basis. That is part of their 13 design basis, and it's a design criteria for them.

14 COMMISSIONER BARAN: Thanks, that's 15 helpful.

16 Bill, I have one question I think is 17 probably for you. And that has to do with how we're going 18 to oversee and inspect the SHINE facility during 19 construction if a construction permit is issued. Our 20 current construction inspectors have inspected against 21 the more detailed information provided in an operating 22 license. How would we ensure that the inspectors are 23 prepared to inspect against a construction permit?

24 MR. DEAN: So, I'll start and there may be 25 some others who can augment, maybe some of our battalion NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

88 1 of witnesses might want to chime in here.

2 So, we'll be leveraging, obviously, the 3 construction inspection experience that we have in 4 Region II to support the construction activities.

5 Clearly, we'll need to develop a construction 6 inspection program much like we did for the Vogtle and 7 VC Summer units. So, we have a model there, obviously, 8 it's going to be scaled down, but I would expect that 9 what we would have would be a replica of a much smaller 10 scale as to what we've done with the construction of the 11 AP-1000s.

12 MS. GAVRILAS: Yes, and we had -- we've done 13 significant work in that direction. And, actually, our 14 Office of New Reactors worked with Region II and, of 15 course, with the rest of us, and there is inspection 16 procedures. And the lead on that was Carl Weber, one of 17 our witnesses, and he can talk about the substance of 18 that procedure.

19 CHAIRMAN BURNS: Okay. Identify yourself, 20 and confirm you've been put under oath.

21 MR. WEBER: My name is Carl Weber. I work for 22 the Office of New Reactors in the Construction 23 Inspection Branch. And I helped to develop the overall 24 inspection program for basically radioactive isotope 25 production. We didn't do a specific program just for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

89 1 SHINE, we made it fairly generic. And what we did was 2 we went back and looked at similar -- programs with 3 similarities. For example, we looked at the Watts Bar 4 program where they were inspecting to a construction 5 permit. We also looked at the mixed oxide facility, and 6 we looked at the Louisiana Energy Services programs. We 7 got a group of people together who had experience in this 8 area, had a working group. We got all their experience, 9 and we developed the program specifically for the 10 radioactive isotope production.

11 CHAIRMAN BURNS: Okay. And confirm you were 12 put under oath before.

13 MR. WEBER: Pardon me?

14 CHAIRMAN BURNS: You did take the oath 15 before?

16 MR. WEBER: Oh, yes. I'm sorry.

17 CHAIRMAN BURNS: Okay, thanks.

18 COMMISSIONER BARAN: Thank you very much.

19 CHAIRMAN BURNS: I appreciate the 20 exploration of the differences in terms of construction 21 permit versus operating license that my colleagues have 22 done so far. A couple of questions I had actually, you 23 know, potentially looking forward. In effect, what we 24 actually have is eight production facilities. Correct?

25 MR. DEAN: Well, there will be eight NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

90 1 individual licenses.

2 CHAIRMAN BURNS: Eight individual. Will 3 there be eight individual licenses --

4 MS. GAVRILAS: Utilization facility.

5 CHAIRMAN BURNS: -- or is this -- would 6 the intention to be combined into one operating license?

7 MS. GAVRILAS: It's eight utilization 8 facilities, the irradiation facilities. And we're 9 looking at that. So, for example, just recently we were 10 scanning 50.56 and we saw one construction permit, one 11 operating license, and then we gave some thought to 12 50.52, that you can have activities from -- that you 13 would license by themselves. You could have them all 14 under one license. But that's all our thinking, it's 15 preliminary. It will depend on what SHINE applies for, 16 and then we'll need to be more rigorous in our 17 considerations.

18 CHAIRMAN BURNS: Okay. And a couple of other 19 questions. And, again, because we're adapting this type 20 of facility to the Part 50 framework, but two others 21 -- so, in this term have you looked down the road as 22 well, we're looking at license -- because I heard 23 someone mention licensed operators. So, we think that's 24 something that would be required or of value as part of 25 this facility licensing?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

91 1 MS. GAVRILAS: SHINE has, I believe, said 2 that they will have operators for the irradiation -- for 3 the radioisotope production part of their facility, so 4 that we need to look into more detail what provisions 5 are in 50.55 for licensing operators, if there's any 6 need for it. So, again, this is exploratory. They're 7 just things that as we're reviewing the construction 8 permit application are coming to mind and we're jotting 9 them down that we need to explore them further for the 10 operating license.

11 CHAIRMAN BURNS: Okay. And I'll just put one 12 more on the plate there, because I saw in the -- I was 13 looking at the draft construction permit and it speaks 14 to the financial protection and indemnity requirements 15 which are under Price-Anderson Act. And, again, it's a 16 Part 50 facility, so I mean looking at the regulations, 17 confirm under Part 140, Part 50 facility has those 18 -- so, again, is that -- now, again, I take it the Staff 19 is looking at those requirements under Price-Anderson 20 to the extent that they would apply. Obviously, this is 21 not a large, you know, 1,300 megawatt or 1,000 megawatt 22 operating plant, so there are different provisions, but 23 I'm presuming that's also something you need to resolve 24 in the longer term for the operating license.

25 MS. GAVRILAS: I've noted your comment.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

92 1 CHAIRMAN BURNS: okay.

2 MS. GAVRILAS: We haven't so far.

3 CHAIRMAN BURNS: Okay. Because it is 4 mentioned in the draft construction permit which is what 5 highlighted it to me.

6 MS. GAVRILAS: Okay, then I'm probably 7 unaware of our discussions.

8 CHAIRMAN BURNS: Okay. One of the things, 9 also, in terms of one of the findings highlighted, one 10 of the findings was that the Applicant is technically 11 and financially qualified for purposes of the 12 construction permit. Can you give me a description of 13 what the Staff did with respect to looking at financial 14 qualifications for the construction permit?

15 MS. GAVRILAS: At a very high level, we 16 basically scrutinized the funds that they have from 17 private investors. We also know that they are funded by 18 the Department of Energy, and we found that to be 19 sufficient for the purpose of construction permit.

20 CHAIRMAN BURNS: Okay, thanks.

21 There is a distinction, I think, made on one 22 of the slides between conditions in -- I think it's on 23 Slide 9. The slide says, "In some cases permit 24 conditions are necessary. In other circumstances" 25 -- then the next bullet says, "Regulatory commitments NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

93 1 track items for resolution in the Final Safety Analysis 2 Report or FSAR."

3 Can the Staff give me a distinction, what 4 elevates itself to a condition versus a commitment that 5 somehow is tracked and how do you track those 6 commitments?

7 MS. BAILEY: The conditions in the 8 construction permit are really associated with the 9 criticality, radiological safety primarily for the 10 radioisotope production facility. Criticality safety, 11 that part of the facility is controlled primarily 12 through geometry and the configuration of design. As 13 SHINE mentioned earlier, the design is preliminary.

14 It's still under development, as well as the analysis 15 that goes with it. So, the permit conditions basically 16 allow the Staff to confirm as the design and the 17 evaluations of the design progress that it's being done 18 in accordance with the design criteria that's described 19 in the Preliminary Safety Analysis Report.

20 What the conditions really do is it gives 21 us the assurance that SHINE will be able to provide the 22 necessary design and technical information in the Final 23 Safety Analysis Report for us to complete our safety 24 evaluation. So part of that goes to Commissioner 25 Svinicki's question about mitigating or avoiding a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

94 1 rework of the facility once construction is well 2 underway or completed.

3 CHAIRMAN BURNS: Okay. My final question 4 relates to the -- stated by the Staff, the Staff used 5 NUREG-1537 which has guidelines for preparation and 6 review of applications related to non-power reactors.

7 And it has some Interim Staff Guidance, there's some 8 Interim Staff Guidance that was used, which states it 9 was prepared for evolving technologies that were not 10 fully developed and demonstrated at the time of 11 publication. What has been your experience with using 12 this Interim Staff Guidance? What do you think you've 13 learned from using it? Is it doing what you hoped it 14 would do?

15 MS. GAVRILAS: It is doing what we hoped it 16 would do. It met our purposes just fine for the 17 construction permit, and we anticipate that it will 18 continue to do so for the operating license. We found 19 one fundamental problem with the guidance as we 20 developed it, and that had to do, we thought that the 21 irradiation facility was going to be able to be reviewed 22 as part of the production facility. That was not the case 23 for SHINE, for example. But other than that, the Interim 24 Staff Guidance works, and we anticipated incorporating 25 it into NUREG-1537 at the next revision of the document.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

95 1 CHAIRMAN BURNS: Okay. And the reason I want 2 to make sure I understand; the two parts of the facility 3 could not be -- I'm trying -- you said they could not 4 be reviewed?

5 MS. GAVRILAS: Yes, we initially --

6 CHAIRMAN BURNS: Explain that.

7 MS. GAVRILAS: I'm going to have to ask for 8 help if this is not enough. But we initially thought that 9 the irradiation facility and the production facility 10 can be treated as one entity. And then when we saw the 11 SHINE application and we started giving more thought, 12 we realized that they're actually distinct and they 13 deserve to be -- they need to be examined separately.

14 CHAIRMAN BURNS: But examined separately in 15 what sense, that the regulatory footprint is different?

16 Again, I think of a large power reactor that has a number 17 -- it has a reactor, it has a number of other buildings 18 that may support it. So, help me along here.

19 MR. DEAN: Can I -- let me just --

20 MS. GAVRILAS: Yes.

21 MR. DEAN: At a high level, I think if you 22 looked at the irradiation facility, that's more like a 23 research and test reactor. Right? Whereas, the 24 radioisotope production facility really has a lot more 25 commonality with a fuel cycle facility.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

96 1 CHAIRMAN BURNS: Okay.

2 MR. DEAN: Chemical processes, so I think 3 that kind of was -- as we looked at the SHINE 4 application, we realized we probably need to treat them 5 sort of independently because of that. I don't know if, 6 Marissa, you have anything you want to add in that 7 regard?

8 MS. BAILEY: I think that's pretty close. I 9 think it's really in terms of what are the applicable 10 acceptance criteria for each type of the facility. So, 11 for example, for the radioisotope production facility 12 because it resembles a fuel cycle facility in terms of 13 processes and hazards, we determined that even though 14 it's licensed under Part 50, we could use the 15 performance objectives in Part 70 to make a 16 determination of acceptability for safety.

17 CHAIRMAN BURNS: Okay. But, ultimately, 18 this is all licensed ---

19 MS. BAILEY: Under Part 50.

20 CHAIRMAN BURNS: Under Part 50, and it's all 21 licensed -- there's not another licensing action going 22 on. I understand that the criteria are different. We've 23 sort of banged this into Part 50 for the subcritical 24 assemblies in those units, and you have this other part 25 which is more like something we -- that NMSS would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

97 1 typically license. But the whole thing is put together, 2 ultimately, under this license.

3 MS. GAVRILAS: That's right.

4 MS. BAILEY: Yes.

5 CHAIRMAN BURNS: Okay. All right, thank you.

6 Commissioner Svinicki.

7 COMMISSIONER SVINICKI: Just a follow-up.

8 In response to the Chairman's question on 9 Price-Anderson indemnification and the Staff's answer, 10 that engendered a very energetic sidebar between 11 counsel for the Staff. Catherine or Mitzi, was there 12 anything counsel for the Staff wanted to respond on 13 that, or is that just you were excited because when the 14 Chairman opens the CFR during the meeting, you know 15 something is going to happen. Right? Did you want to 16 provide any augmentation to the Staff's answer on that?

17 You could say no, it's fine. You don't have to. I'm not 18 saying explain yourselves. I'm just saying, did you want 19 to supplement their answer?

20 MS. YOUNG: Mitzi Young, counsel for the NRC 21 Staff. First of all, let me defend myself. We've been 22 animated through the whole hearing. Every time you ask 23 a question we're excited because many of the questions 24 you asked are questions we practiced with them in part, 25 so this has been exciting from a number of respects. But NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

98 1 in terms of Price-Anderson, that is part of the review.

2 I believe 140 talks about a certain power level for 3 reactors, and I think what SHINE did in their 4 application, and Steven Lynch is obviously more 5 conversant on this than myself. They looked at 6 comparable power thermal output to identify what level 7 of Price-Anderson protection they would need. To the 8 extent that they're not receiving Special Nuclear 9 Material to get a construction permit, that assurance 10 is not needed now, but it would be part of the operating 11 license review.

12 Steve, was there anything you wanted to 13 add?

14 MR. LYNCH: That's it.

15 MS. YOUNG: Thank you.

16 CHAIRMAN BURNS: All right, thanks very 17 much, Mitzi.

18 COMMISSIONER SVINICKI: Thank you.

19 CHAIRMAN BURNS: Thanks, Commissioner.

20 With that, we'll take a brief break and then 21 resume with Safety Panel 1. So, try to be back in your 22 seats in about five or six minutes.

23 (Whereupon, the proceedings went off the 24 record at 11:05 a.m., and went back on the record at 25 11:15 a.m.)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

99 1 CHAIRMAN BURNS: We'll call the hearing 2 back to order. In this next session we'll have Safety 3 Panel 1 and we'll hear first from the Applicant, SHINE.

4 We'll immediately follow that with the staff's 5 presentation for Safety Panel 1 and then follow with 6 Commissioner questions. And in general the topics will 7 cover the chapter 1 of the Safety Evaluation Report with 8 respect to the facility, and chapter 4, irradiation unit 9 and radioisotope production facility description to 10 address the licensing considerations for the 11 subcritical utilization facilities and production 12 facility.

13 So with that, we'll go to our first panel 14 from SHINE. Mr. Hennessy and Mr. Van Abel are here, 15 but, Ms. Kolb, I'll ask you to introduce yourself.

16 MS. KOLB: My name is Catherine Kolb. I'm 17 a supervisor in engineering for SHINE Medical 18 Technologies.

19 CHAIRMAN BURNS: Okay. Thanks very much.

20 And again, assume that the Commission is generally 21 familiar with the prehearing filings, and I remind you 22 you're under oath. And please proceed.

23 MR. VAN ABEL: All right. Good morning 24 again. In this presentation I'd like to give a brief 25 continuing discussion on the facility.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

100 1 If we'd go to the next slide, slide 2. Here 2 again is the overall facility process overview. We 3 went through this in some detail in the overview 4 discussion. I'm going to add a little additional 5 detail on the design requirements for these SSCs in this 6 presentation, but of course if we have any other 7 questions on the overall facility design, happy to 8 answer those as well.

9 Next slide, please. For the SHINE 10 facility certain SSCs are designated as safety-related 11 in our facility because they are relied upon to perform 12 safety functions either during normal operations or 13 during design-basis events. And those SSCs that are 14 required to perform safety functions are required to 15 perform those in the environmental conditions of normal 16 operation and any accidents in which they are required 17 to function. For those SSCs that have safety 18 significance, we design them, fabricate them and test 19 them commensurate with the criteria set forth in 20 ANSI/ANS-15.8, which are the quality assurance 21 requirements for research reactors. SHINE implements 22 that ANSI/ANS-15.8 standard through our Quality 23 Assurance Program description, or QAPD.

24 Next slide, please. On this slide we have 25 the safety-related definition that SHINE applies to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

101 1 design. This is a comprehensive definition that we've 2 modified from 10 CFR 50.2 and we've also included the 3 requirements from 10 CFR 70.61, the performance 4 requirements there as they're applicable to the 5 radioisotope production facility.

6 The SSCs that are safety-related are those 7 that are relied upon to meet any of the six criteria 8 listed here. The first three are modifications of 10 9 CFR 50.2 and include the integrity of the primary system 10 boundary, the capability to shut down our target 11 solution vessel and irradiation process and maintain it 12 shutdown, and the capability to prevent accident dose 13 consequences that would exceed 10 CFR 20.

14 And the last three are familiar to the fuel 15 cycle facility folks. These are to ensure that our 16 nuclear processes remain subcritical including the use 17 of an approved margin of subcriticality, to ensure that 18 chemical exposures from accidents are acceptable for 19 both the worker and the public, and that an intake of 20 30 milligrams or greater of soluble uranium does not 21 occur for personnel outside the owner-controlled area, 22 the OCA.

23 Next slide, please. For our SSCs we 24 require them to be designed to withstand external 25 events. Our outer building structure is designed to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

102 1 resist external events such as tornadoes, aircraft 2 impacts and other external events. And also the SSCs 3 within the building are required to withstand our 4 design-basis earthquake if they perform a 5 safety-related function or they're necessary to ensure 6 they do not degrade the performance of a safety-related 7 SSC.

8 We also apply a graded quality level to the 9 design of our SSCs. We have three quality levels as 10 described here. Quality Level 1 is applied to our 11 safety-related components SSCs, and that is the full 12 measure of our QAPD is applied to those SSCs. Also, we 13 apply Quality Level 2 to SSCs that could affect the 14 safety function of safety-related SSCs specifically to 15 support or protect the safety function of those SSCs.

16 And we apply graded quality to those components that's 17 commensurate with their importance to safety. And 18 Quality Level 3 is applied to those SSCs that don't meet 19 the definition of Quality Level 1 or 2.

20 Next slide, please. We also apply single 21 failure criterion to our systems. For safety systems 22 we ensure that there is sufficient redundancy and 23 independence such that a single failure of an active 24 component does not result in the loss of capability to 25 perform the safety function. And for accident analysis NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

103 1 we ensure that a single failure in conjunction with the 2 initiating event does not result in the loss of the 3 safety system's ability to perform the safety function.

4 So throughout our design process we use a robust 5 defense-in-depth approach to design, and we have a 6 strong preference in the design for passive and 7 engineered controls over administrative controls. And 8 that concludes my presentation.

9 CHAIRMAN BURNS: Okay. Thank you. And 10 I'll ask the staff witnesses to come forward, take their 11 seats at the table.

12 And I remind you that you're under oath and 13 start with the introduction of the witnesses. Start 14 with you, Mr. Lynch.

15 MR. LYNCH: My name is Steve Lynch. I'm 16 the project manager for SHINE Medical Technologies on 17 the NRC staff.

18 MR. ADAMS: My name is Al Adams. I'm the 19 Chief of Research and Test Reactor Licensing in NRR.

20 MS. ADAMS: Mary Adams. I'm an engineer 21 in the Division of Fuel Cycle Safety Safeguards and 22 Environmental Review in NMSS.

23 CHAIRMAN BURNS: Okay. Thank you.

24 Please proceed.

25 MR. ADAMS: Good morning. This panel will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

104 1 discuss the unique licensing considerations of the 2 SHINE utilization and production facilities. I will 3 discuss the general licensing considerations and a 4 review performed by the Advisory Committee on Reactor 5 Safeguards, the ACRS. Steve Lynch will discuss the 6 licensing of the irradiation units and Mary Adams will 7 discuss the licensing of the production facility.

8 Next slide, please. SHINE seeks to 9 construct non-power utilization facilities and a 10 production facility. Therefore, an initial 11 consideration was whether to license SHINE's proposed 12 facilities under Section 103 or Section 104 of the 13 Atomic Energy Act. While the hazards associated with 14 SHINE's facility are similar to non-power research 15 reactors which are licensed under Section 104 of the 16 Atomic Energy Act, SHINE's facility is intended to be 17 used for commercial purposes, not for conducting 18 research and development or medical therapy.

19 Therefore, while the licensing process would be similar 20 to a research reactor, SHINE's facility would be 21 licensed under Section 103 of the Atomic Energy Act.

22 Section 103 imposes additional procedures 23 on construction permit applications including an 24 independent review of the application by the ACRS and 25 a mandatory hearing, which we are having today.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

105 1 Because SHINE's facility is a subcritical system which 2 produces fission power, it introduces aspects of a 3 review typically done for non-power reactors. For 4 these areas the staff developed and used the Interim 5 Staff Guidance for NUREG-1537, which is a standard 6 review plan for non-power reactors.

7 Next slide, please. The staff presented 8 the results of its safety review at three ACRS 9 Subcommittee meetings and before the full ACRS. During 10 its review the ACRS identified two safety concerns that 11 could impact the operation of the SHINE facility if not 12 sufficiently addressed. These concerns were the 13 capability to lay up the facility and the facility's 14 ability to withstand potential aircraft impact.

15 SHINE and the staff provided additional 16 information to the ACRS in these areas. The ACRS 17 determined that sufficient information was provided 18 such that it could recommend the issuance of a 19 construction permit. This recommendation is reflected 20 in the ACRS letter dated October 15th, 2015, which is 21 in the staff's SER.

22 The ACRS letter also noticed several issues 23 that must be addressed at the operating license stage 24 including criticality control and margin. The staff 25 agrees that each item that the ACRS identified must be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

106 1 addressed at the operating license stage. And Mirela 2 was correct during her testimony that written comments 3 were not provided, or written commitments were not 4 provided by SHINE in all these areas, however, the staff 5 is aware of them and we determined that they're not 6 needed for the issuance of the construction permit, but 7 will be addressed at the operating license stage.

8 Next slide, please. Steve Lynch will now 9 discuss specific licensing considerations related to 10 the SHINE irradiation facility.

11 MR. LYNCH: Thanks, Al. SHINE's proposed 12 irradiation units presented unique licensing 13 considerations under 10 CFR Part 50, which has 14 traditionally been applied to the construction and 15 operation of nuclear reactors. However, unlike 16 nuclear reactors, SHINE's irradiation units are not 17 designed to go critical during operation. Therefore, 18 SHINE's irradiation units represent a new application 19 of technology.

20 Given their subcritical nature, the staff 21 considered whether it should review SHINE's irradiation 22 units under 10 CFR Part 70, which can be applied to 23 certain facilities that possess and use special nuclear 24 material. However, these facilities, generally 25 referred to as fuel cycle facilities, have the common NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

107 1 objective of avoiding criticality by a significant 2 margin under both normal operating and accident 3 conditions. In contrast, SHINE's minimal margin of 4 subcriticality is less than what has been previously 5 approved for other 10 CFR Part 70 licensees and more 6 closely resembles the operating state of a nuclear 7 reactor.

8 Because of this the staff determined that 9 it would be most appropriate to use the 10 CFR Part 50 10 regulations for utilization facilities to perform its 11 technical review of the irradiation units. Therefore, 12 the NRC issued a direct final rule that revised the 13 definition of utilization facility in 10 CFR 50.2 to add 14 SHINE's subcritical operating assemblies. If 15 licensed, SHINE's irradiation units would be the first 16 utilization facilities to operate in a minimally 17 subcritical range.

18 Next slide, please. Classifying SHINE's 19 irradiation units as utilization facilities allowed the 20 staff to conduct its review following the regulations 21 designed for technologies with similar radiological, 22 health and safety considerations. In particular, the 23 accelerator and neutron multiplier of each irradiation 24 unit achieve a fission rate with a thermal power level 25 comparable to that of other non-power reactors licensed NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

108 1 under 10 CFR Part 50. Because of their thermal power 2 levels the irradiation units share similar safety 3 considerations with other non-power reactors, 4 including provisions for the removal of fission heat 5 during operation, passive decay heat generation after 6 shutdown, fission gas 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 Staff 11 Guidance for aqueous homogeneous reactors to conduct 12 its review. Specific design areas of the staff's 13 review included SHINE's reactivity control mechanisms, 14 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.

24 The RPF also consists of several physical 25 and chemical processes that are similar to those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

109 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 Staff 8 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 analysis 14 guidance which include the criteria in 10 CFR 70.64. As 15 noted in the guidance, an application meeting these 16 baseline design criteria would be found acceptable by 17 the staff. SHINE's construction permit application 18 proposed these acceptable baseline design criteria for 19 the RPF. After reviewing the application, the staff 20 finds that SHINE's application met these baseline 21 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

110 1 conditions. In particular, the staff has proposed four 2 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 and 13 occupancy times within the RPF are consistent with as 14 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 begin 24 our questions. And we'll begin our questions for this 25 panel with Commissioner Ostendorff.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

111 1 COMMISSIONER OSTENDORFF: Thank you, 2 Chairman, and thank you all for your briefs. I do have 3 a question for the Applicant, and I'm going to your slide 4 6. And under the single failure criterion being 5 applied to safety systems, I just wanted to ask a 6 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 of the ability 9 to perform its function? Can you talk about how you 10 apply that concept to reliability of electrical power 11 as it affects instrumentation control or alarms?

12 MR. VAN ABEL: Yes, for instrumentation 13 control and electrical power we have very minimal 14 requirements for those for safety-related purposes.

15 And those that we do have are primarily for hydrogen 16 mitigation after shutdown and some instrumentation 17 control systems that monitor the system after shutdown.

18 And those are provided by an uninterruptible power 19 supply system that will be designed based on single 20 failure criterion to look at failure of components such 21 as a breaker supplying power to ensure that there's 22 redundant reliable means to supply that power to the 23 equipment requiring it.

24 COMMISSIONER OSTENDORFF: With respect to 25 your criticality alarm system, does that have redundant NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

112 1 power supplies? Or that may not have been designed yet; 2 I don't know, but where does that fall with respect to 3 this philosophy of redundancy?

4 MR. HENNESSY: It would be. It's not 5 designed yet, but it's a safety-related system, so --

6 COMMISSIONER OSTENDORFF: Okay.

7 MR. HENNESSY: -- these same design 8 principles would apply.

9 COMMISSIONER OSTENDORFF: Okay. Thank 10 you.

11 Let me shift back to the staff now. Mary, 12 I wanted to ask you a question on your slide, I think 13 7 -- excuse me, 8. There's a reference to criticality 14 events not being credible. Can I just ask you to 15 elaborate on that just a little bit about what's the 16 basis for that statement?

17 MS. ADAMS: 10 CFR 70.61, which formed the 18 basis of the Interim Staff Guidance, states as an 19 acceptance criterion that all processes need to be 20 subcritical under normal and credible abnormal 21 operating conditions. And so, what exactly does 22 "credible abnormal" mean? And we ask our applicants to 23 very carefully define what they mean by credible and not 24 credible with respect to criticality safety.

25 COMMISSIONER OSTENDORFF: So with respect NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

113 1 to the design aspects of what's been presented to the 2 NRC staff how is that achieved?

3 MS. ADAMS: I want to call on --

4 COMMISSIONER OSTENDORFF: Or as a 5 condition of not having a credible criticality event.

6 MS. ADAMS: I'd like to call on Dr. Chris 7 Tripp to answer that question.

8 CHAIRMAN BURNS: Okay. And please 9 identify yourself for the record and confirm that you 10 took the oath earlier.

11 DR. TRIPP: Okay. I'm Christopher Tripp.

12 I'm the criticality safety reviewer in FCSS for the RPF, 13 and, yes, I did take the oath.

14 CHAIRMAN BURNS: Okay. Please proceed.

15 DR. TRIPP: Okay. With regard to 16 credibility, when SHINE originally provided their PSAR 17 section on criticality safety, they said that they were 18 going to design it so that criticality would be not 19 credible and then any controls so identified would be 20 identified as SSCs. This was meant to meet the 21 performance requirements.

22 Some of those criteria that were mentioned 23 were from the performance requirements of Part 70. And 24 the usual approach on the Part 70 side has been that we 25 required criticality and other high-consequence events NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

114 1 to be highly unlikely and then those items would be 2 identified as items relied on for safety under the Part 3 70 framework. So there seemed to be some confusion as 4 to what the exact -- how that would be applied to the 5 RPF.

6 And in the fuel cycle area we have had a lot 7 of discussions in the existing fuel facilities 8 concerning the basis for deciding events are credible 9 or not credible, and when you have to make that 10 demonstration and what you're allowed to take credit 11 for. So this has been an ongoing issue with the 12 industry. Therefore, we proposed these conditions to 13 give us additional confidence that they understood what 14 they were committing to to be able to apply that 15 acceptably in the design.

16 COMMISSIONER OSTENDORFF: Okay. Well, 17 are you expecting this condition to lead to articulation 18 of specific engineered features as far as volume control 19 on solution or can you be a little more specific as to 20 how this might play out in the facility's actual design?

21 DR. TRIPP: Yes. So the first step in 22 applying the criteria -- the main criteria for 23 criticality is they be subcritical under normal and 24 credible abnormal conditions. So the first step of 25 that is identifying what are the credible criticality NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

115 1 hazards and then designing the different safety 2 barriers against that. So it's at that first step of 3 deciding what is credible and what hazards have to be 4 protected against that we would want to make sure that 5 they had an acceptable way of doing that.

6 COMMISSIONER OSTENDORFF: So what are some 7 examples? I'm trying to get to a more practical 8 engineered feature discussion here. What are some 9 examples of how the licensee might satisfy that 10 condition?

11 DR. TRIPP: Well, there are three criteria 12 for what they consider credible: One is an external 13 event with frequency of 10 to the minus 6th based on the 14 fuel cycle guidance that was incorporated into the ISG.

15 The other is basically a string of independent events 16 that together collectively make up a set of unlikely 17 events that would have to occur that we wouldn't think 18 are credible. And the third is that they'd be 19 physically impossible.

20 COMMISSIONER OSTENDORFF: So is there an 21 example of the physically impossible that you can offer 22 for us?

23 DR. TRIPP: Well, we don't have specific 24 examples that apply directly to SHINE because we haven't 25 reviewed specific design features at this point. We've NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

116 1 only reviewed the design criteria. But in the other 2 fuel cycle arrangement -- for example, most of the 3 processing, the solution processing, which is similar 4 to what they have in other parts of the fuel facility, 5 are in safe geometry containers, safe geometry columns 6 and so forth. And one of the things you have to guard 7 against is backflow. So a lot of the time they're 8 protected against with say a siphon break or an overflow 9 or something of that nature so that -- liquid doesn't 10 flow against gravity. That would be considered 11 incredible. But it's only based on having that passive 12 feature in the design.

13 COMMISSIONER OSTENDORFF: Okay. That 14 example was very helpful. Thank you. Thank you, 15 Chairman.

16 CHAIRMAN BURNS: Thank you. Commissioner 17 Baran?

18 COMMISSIONER BARAN: Thanks. I want to 19 ask about slide 4 of SHINE's presentation which relates 20 to the definition of structures, systems and 21 components. The proposed definition, SSC definition 22 states in bullet 3 that SSCs assure the capability to 23 prevent or mitigate the consequences of accidents which 24 could result in potential exposures comparable to Part 25 20. The definition also states in bullet 6 that SSCs NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

117 1 assure that an intake of 30 milligrams or greater of 2 uranium in soluble form by any individual located 3 outside the owner control area does not occur.

4 The NRC's occupational dose requirements 5 in Part 20 state that the licensee shall limit the 6 soluble uranium intake by an individual to 10 milligrams 7 in a week in consideration of chemical toxicity. Can 8 SHINE discuss the basis for setting the SSC definition 9 at no more than 30 milligrams? How does that line up 10 with -- how is that reconciled with the Part 20 11 requirements?

12 MR. HENNESSY: The definition in Part 6, or 13 the term in Part 6 was derived from the 10 CFR 70.61 14 performance requirements, and that's what it reflects 15 back as.

16 As far as the 10 CFR 20 requirements, our 17 concern, they would still be applicable and we would 18 still apply that under No. 3. So we'll have to look at 19 your --

20 COMMISSIONER BARAN: Okay.

21 MR. HENNESSY: -- comment and think about 22 that.

23 COMMISSIONER BARAN: Do you know if 24 there's a time frame that applies to the 30-milligram 25 level?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

118 1 MR. HENNESSY: I'm not aware of one.

2 COMMISSIONER BARAN: Okay.

3 MR. HENNESSY: Eric, do you have any idea?

4 MR. VAN ABEL: It's for an accident 5 evaluation for --

6 COMMISSIONER BARAN: Okay.

7 MR. VAN ABEL: -- normal operations.

8 COMMISSIONER BARAN: So that's basically 9 total intake --

10 MR. VAN ABEL: Yes. Right.

11 COMMISSIONER BARAN: -- over whatever 12 period of time?

13 MR. VAN ABEL: That's correct.

14 COMMISSIONER BARAN: Okay. And then the 15 Part 20 standards have a limit of 10 milligrams per week.

16 Maybe I'll ask the staff to comment on this. How did 17 you all conclude that the proposed definition element 18 of an intake of 30 milligrams of uranium in soluble form 19 is an acceptable limit for the definition?

20 MS. ADAMS: I'd like to call on Greg 21 Chapman, the health physicist who reviewed the RPF.

22 MR. CHAPMAN: Greg Chapman, NMSS, health 23 physicist. I did take the oath.

24 CHAIRMAN BURNS: Great.

25 MR. CHAPMAN: With regards to the 10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

119 1 milligram or 30-milligrams, 30 milligrams is typically 2 the criteria that were replaced with the public for Part 3 70-type review. And we typically look at it as an acute 4 exposure over 24 hours1 days <br />0.143 weeks <br />0.0329 months <br />. So 10 milligrams for accident 5 exposure as well as 30 milligrams, I would apply the same 6 criteria, 24 hours1 days <br />0.143 weeks <br />0.0329 months <br />.

7 COMMISSIONER BARAN: Okay. And so under 8 this definition the potential intake from a member of 9 the public of 30 milligrams looks to be about 3 times 10 higher than the limit you would have over the course of 11 a week for someone working at the facility, is that 12 right?

13 MR. CHAPMAN: That's correct.

14 COMMISSIONER BARAN: Okay. And can you 15 tell us a little bit more about how when you evaluated 16 that that that seemed like an acceptable result?

17 MR. CHAPMAN: I'd have to get back with you 18 on that. I can't recall at the moment.

19 COMMISSIONER BARAN: I don't know if this 20 is a matter of a temporal issue here or there's something 21 else at play, but maybe you could get back to us on that.

22 Al or Steve, in prehearing question 15 we 23 asked whether the application specified how many 24 irradiation units a single operator could control, and 25 both the staff and SHINE stated that that would be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

120 1 addressed during the operating license application.

2 Can you talk a little bit about how the number of 3 operators relates to the size of the control room and 4 whether that's an issue that needs to be resolved now 5 at the construction permit stage?

6 MR. LYNCH: So that is something that we 7 haven't looked extensively at the construction permit 8 stage. Some of the considerations: More than just the 9 size of the control room, we're looking at the layout 10 of the control room, especially if there will be 11 operators looking at the production facility versus the 12 irradiation facility, and we need to get a better 13 understanding of how the controls will be laid out and 14 to make a determination on the number of operators that 15 are needed.

16 COMMISSIONER BARAN: Okay. So in terms of 17 getting at the issue that Commissioner Svinicki raised 18 about not wanting a situation where someone has a 19 construction permit, they build something out, we look 20 at it later and say, no, no, that's not going to work 21 and people have to kind of redo things, from the staff's 22 point of view is the number of operators, total number 23 of operators that would be working in the control 24 room -- is that going to be relevant to the layout, the 25 construction of that control room in a way that makes NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

121 1 it something that we should address now at the 2 construction permit stage, or, no, it's just an 3 operating license issue?

4 MR. LYNCH: So based on the information 5 SHINE has provided in their PSAR and discussions we had 6 with the ACRS on this issue, the staff hasn't noted 7 anything that would prevent the facility from being able 8 to operate.

9 COMMISSIONER BARAN: Okay. I want to also 10 ask about, follow up on prehearing question 11 related 11 to the probabilities used for aircraft accidents and 12 external design-basis accidents. I'm interested in 13 how the staff selected the size of the aircrafts for this 14 hazard analysis. Did the staff look only at the types 15 of aircraft that could land or take off from the nearest 16 airport that the facility intends to be using quite a 17 bit, or did you also assess larger aircraft that could 18 potentially pass through the air space near the proposed 19 facility?

20 MR. LYNCH: I think the best person to 21 respond to this question would be Steve Marschke.

22 CHAIRMAN BURNS: Again, Mr. Marschke, just 23 state your name for the record and your position and 24 confirm that you were put under oath.

25 MR. MARSCHKE: My name is Steve Marschke.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

122 1 I work with Sanford Cohen & Associates, and we're 2 consulting staff on the chapter 2 review. And, yes, I 3 did take the oath.

4 When we looked at the aircraft accident 5 probability analysis, we looked at really what SHINE has 6 done. And they looked at all the accidents which 7 are -- or all the aircraft which land and take off at 8 that airport, the Southern Wisconsin Regional Airport.

9 And they have the statistics from the FAA which 10 identifies the types of aircraft, military aircraft.

11 And most of them are air carriers and commuter aircraft 12 and those types of aircraft. They've been grouped into 13 those categories. They also looked at air corridors, 14 which transverse the area. And so, we kind of just -- we 15 reviewed what the SHINE facility has done.

16 COMMISSIONER BARAN: In terms of those air 17 corridors -- so this is a relatively small regional 18 airport. I assume the planes as you described are 19 relatively small that will be taking off and landing 20 from there. Are the air corridors that SHINE examined 21 and that you all looked at -- are those corridors that 22 involve much larger aircraft? When we talk about 23 planes going to like O'Hare Airport in Chicago or --

24 MR. MARSCHKE: The air corridor is -- the 25 probabilities associated with the traffic in the air NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

123 1 corridors were very low. And so, the air corridors 2 themselves fell below the probability cutoffs. And 3 it's really the aircraft which are utilizing the 4 regional airport which challenge the probability 5 cutoffs.

6 COMMISSIONER BARAN: Okay. So any larger 7 aircraft beyond what would land or take off at the 8 regional airport didn't kind of pass the probabilities 9 level to be examined. Is that correct?

10 MR. MARSCHKE: That's correct.

11 COMMISSIONER BARAN: Okay. Thank you.

12 And just one more question. Prehearing question 35 13 focused on the assessment of accidental explosions at 14 the SHINE facility. SHINE's response to the question 15 stated that they analyzed the potential impact of 16 natural gas pipelines on the facility. Can the staff 17 or SHINE, whoever makes sense; maybe the staff, Al or 18 Steve -- can you clarify which natural gas pipelines are 19 in the area of the proposed facility and how the staff 20 determined that they were not hazards?

21 MR. LYNCH: I think we're going to ask to 22 get some help here as well.

23 COMMISSIONER BARAN: You're back.

24 MR. MARSCHKE: I'm back.

25 (Laughter)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

124 1 MR. MARSCHKE: Can't get enough.

2 CHAIRMAN BURNS: Still under oath.

3 MR. MARSCHKE: Yes. Well, my answer is 4 going to be I'm going to have to get back to you on that, 5 because in preparing for today's meeting I wasn't really 6 looking at the pipelines. I wasn't anticipating -- I 7 was anticipating the aircraft questions, but not the 8 pipeline questions, and so I haven't briefed myself.

9 Maybe after lunch I can look at my notes and get back 10 in touch.

11 COMMISSIONER BARAN: Is this something 12 that the staff has looked at?

13 MR. MARSCHKE: No, we have looked at it, 14 but I just haven't looked at it recently and I don't want 15 to misinform the Commissioners.

16 COMMISSIONER BARAN: Okay.

17 CHAIRMAN BURNS: What we can do, we can 18 either hold to the end of the day if the staff wishes 19 to provide a supplemental answer, or we'll proceed with 20 putting it for perhaps a question following up.

21 COMMISSIONER BARAN: That makes sense.

22 Thank you, Mr. Chairman.

23 CHAIRMAN BURNS: Thanks, Commissioner.

24 COMMISSIONER BARAN: That's all my 25 questions. Thank you.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

125 1 CHAIRMAN BURNS: A couple things: Just I 2 guess to -- given some of my colleagues' questions 3 regarding the facility and all, can -- probably the 4 Applicant's the best idea. In looking at some of the 5 slides -- it's actually from the first -- the overview 6 presentation, can you give me an idea of the footprint, 7 the area or size of the facility itself? Because I've 8 got a picture, but it could be a doll house or a large 9 enrichment facility. So just give me an idea of the 10 footprint.

11 MR. HENNESSY: The main building size is 12 around 55,000 square feet --

13 CHAIRMAN BURNS: Okay.

14 MR. HENNESSY: -- which is a little over an 15 acre in size. The whole site is 91 acres, so --

16 CHAIRMAN BURNS: Yes.

17 MR. HENNESSY: -- we're a dot in the middle 18 of a large area.

19 CHAIRMAN BURNS: Okay. And so 20 location-wise within that 91 acres are you sort of in 21 the middle of it? Is that the intention?

22 MR. HENNESSY: Yes.

23 CHAIRMAN BURNS: So you have a large -- in 24 fact what we'd call in a reactor facility the 25 owner-controlled area in that case?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

126 1 MR. HENNESSY: That's correct.

2 CHAIRMAN BURNS: Okay. What is 3 this -- and I'm looking and I just don't recall -- what 4 is the seismic design-basis for the facility? Either 5 the Applicant or the staff can respond to that.

6 MS. KOLB: The staff can -- or I mean SHINE 7 can respond to that. I'd like to ask Alan Hull to take 8 that.

9 CHAIRMAN BURNS: Okay.

10 MR. HULL: Good morning. My name is Alan 11 Hull. I work for Golder Associates. I'm a seismic 12 hazard specialist.

13 CHAIRMAN BURNS: And you were put under 14 oath earlier?

15 MR. HULL: I was put under oath, yes, and 16 I took it.

17 CHAIRMAN BURNS: Please proceed.

18 MR. HULL: So for the design-basis 19 earthquake you notice there were three stages. I can 20 comment only on the analysis that was done to come up 21 with the ground shaking, and the structural engineer for 22 SHINE will be able to talk about how that flowed on into 23 the actual design of the facilities.

24 From our analysis we found that this part 25 of the United States is one of the lowest seismic hazards NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

127 1 in the area. In fact, there were only about 58 2 earthquakes within 200 miles in the last 200 or so years.

3 So when we looked at where the seismic design should come 4 from, we analyzed all those facilities as we might have 5 done for a power reactor.

6 CHAIRMAN BURNS: Yes.

7 MR. HULL: And by looking at the United 8 States geological survey seismic hazard model for the 9 United States we determined that a magnitude 5.8 10 earthquake is the likely design-basis or maximum 11 earthquake for this facility. The standard is about 12 0.2 g.

13 CHAIRMAN BURNS: Okay.

14 MR. HULL: That's 20 percent of the force 15 of gravity. We looked at that seismic hazard model for 16 the United States and found that has a return period of 17 about 20,000 years.

18 CHAIRMAN BURNS: Okay. And my 19 recollection from a long time ago dealing with some 20 other facilities is that 0.2 g -- the shaking force is 21 more or less equivalent to what I think a number of the 22 other reactors are designed for.

23 MR. HULL: That's my understanding. And 24 my understanding also -- and again, a structural 25 engineer from Sargent & Lundy could provide more detail.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

128 1 My understanding is that that value of 0.2 g is being 2 used for the structural design of the Quality 1 3 facilities.

4 CHAIRMAN BURNS: Okay. All right.

5 Thanks very much.

6 The other thing is I'd ask the Applicant; 7 and the staff can certainly add, is what analysis of 8 flooding hazards were done with respect to the site?

9 And again, I know nothing of the site, so it may be a 10 silly question and it may not be. But, please.

11 MS. KOLB: We did do flooding hazards 12 analysis. We looked at the probable maximum 13 precipitation events and the probable maximum flood.

14 The Rock River is about two miles from the site, but the 15 difference in elevation from the site elevation to the 16 Rock River, even in the probable maximum flood 17 situation, is still about 50 feet below the elevation 18 of the site. So that was determined to not pose a hazard 19 to the facility.

20 For the probable maximum precipitation 21 based on the area of the site, it comes up to about the 22 elevation of the site in the probable maximum 23 precipitation event, which we did analyze, but it does 24 not flood the structure. And if you'd like more detail, 25 we have a geotechnical engineer from Golder that could NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

129 1 answer, provide more detail.

2 CHAIRMAN BURNS: I think that's good for 3 now. Thank you.

4 The final question I'll have here is with 5 respect to any analyses that were done with respect to 6 control or mitigation of release of tritium from the 7 facility since it does use tritium, and that's been an 8 issue, and it may be again. Because of the design it 9 may not be as much of an issue for you all, but it has 10 been an issue at some nuclear power plant sites.

11 MR. VAN ABEL: Yes. Yes, as I mentioned 12 before, we have a tritium purification system and the 13 accelerators themselves use a tritium gas target.

14 There are number of features there to control and 15 prevent the release of tritium to the environment. One 16 of the primary ones is that second confinement barrier, 17 the double-walled pipe around the tritium piping. And 18 the tritium processing equipment is in glove boxes, and 19 those glove boxes are continuous scrubbing of the 20 atmosphere to remove tritium from the atmosphere, the 21 glove box and maintain that concentration extremely 22 low. And any discharges from the glove box are 23 monitored and ensured that they're below acceptable 24 limits.

25 CHAIRMAN BURNS: Okay. Thank you very NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

130 1 much. Thank you. Commissioner Svinicki?

2 COMMISSIONER SVINICKI: Thank you all for 3 your presentations. I just have one question. It can 4 be for either the staff or the Applicant and which 5 subject matter expert I guess gets to a microphone more 6 quickly, because it's kind of a background question.

7 10 CFR Part 50, Appendix B QA Program 8 requirements are applicable to power reactors, so they 9 are not in the strictest sense applicable to the SHINE 10 construction permit application. SHINE's slide 3 11 states that the application was prepared in accordance 12 with the criteria set forward in ANSI/ANS-15.8 QA for 13 research reactors.

14 Could someone though who is familiar -- I'm 15 more familiar with Appendix B and the component elements 16 of that. What is it that is missing or sacrificed in 17 terms of not using Appendix B versus using the ANSI/ANS 18 standard? Both to my knowledge provide for a graduated 19 approach to QA requirements, so is there any QA expert 20 of the staff or the Applicant who could tell me kind of 21 what is sacrificed between the two? I assume that the 22 Part B -- Appendix B, I'm sorry, QA Program is more 23 rigorous somehow.

24 Well, I mean, maybe -- and the other 25 question would be; and maybe this will be a follow-up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

131 1 or something to be answered at the end of the day, if 2 possible. Are all the requisite elements that are 3 required in an Appendix B program for coverage of 4 QA -- are those same elements addressed in the ANSI/ANS 5 standard?

6 MR. ADAMS: I think I can --

7 COMMISSIONER SVINICKI: Okay. Thank you.

8 MR. ADAMS: -- take a try at that. So 9 indeed the research reactors follow ANS 15.8, which is 10 endorsed by Regulatory Guide 2.5, Quality Assurance 11 Requirements for Research and Test Reactors. This 12 standard was developed by the ANS 15 Committee, Research 13 and Test Reactor Committee, and it was developed because 14 Appendix B did not apply to research reactors as 15 written.

16 The coverage areas are the same. In fact, 17 the ANS standard goes a little bit further because it 18 includes additional quality assurance area of 19 experiments, which you don't see in power reactors.

20 Also, the ANS standard was written with the realization 21 that the definition of SSCs in the regulations was 22 written for power plants and may not be strictly 23 applicable to research reactors.

24 Are you sacrificing something? The staff 25 does not believe so given the difference between power NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

132 1 reactors and research and test reactors. Based on the 2 Quality Assurance Program from SHINE, the answers to 3 RAIs and the scope of the standard, and also the Interim 4 Staff Guidance to NUREG-1537 we believe that using ANS 5 15.8 is applicable for meeting the requirements in 6 50.34(a)(7) for a Quality Assurance Program.

7 COMMISSIONER SVINICKI: Okay. Thank you.

8 That's a very complete answer. I don't require any 9 supplement to that. Thank you, Mr. Chairman.

10 CHAIRMAN BURNS: Okay. Well, thank you to 11 our morning panels for their presentations. We will 12 now adjourn until 1:30 p.m. and we'll take up Safety 13 Panel 2.

14 (Whereupon, the above-entitled matter went 15 off the record at 11:59 a.m. to reconvene at 1:30 p.m.)

16 CHAIRMAN BURNS: Okay, we'll call the 17 afternoon session of the hearing on the SHINE 18 application to order for a Construction Permit.

19 I'll ask the -- well, actually, what we'll 20 do, we'll hear both from the Applicant and then we'll 21 hear from the staff. The staff can stay where they are 22 for the time being.

23 But, we'll proceed with this afternoon's 24 panel. I'll remind the witnesses that they are under 25 oath and ask you to introduce yourselves again as we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

133 1 begin the afternoon session. And then, you can 2 proceed.

3 MR. COSTEDIO: I'm Jim Costedio. I'm the 4 SHINE Licensing Manager.

5 MR. HENNESSY: Bill Hennessy, the Manager 6 of Engineering for SHINE.

7 MS. KOLB: Catherine Kolb, I'm an 8 Engineering Supervisor.

9 MR. VAN ABEL: Eric Van Abel, Engineering 10 Supervisor.

11 CHAIRMAN BURNS: Okay, please proceed.

12 MR. VAN ABEL: Good afternoon.

13 For Safety Panel 2, I'd like to discuss the 14 Accident Analysis as presented in SHINE's PSAR.

15 The basis for identification of accidents 16 for our PSAR was a Hazards and Operability Study. We 17 performed the HAZOPS, a Preliminary Hazards Analysis, 18 a PHA. Both of those are rolled up into an Integrated 19 Safety Analysis.

20 We also used the events from NUREG-1537 and 21 the ISG augmenting NUREG-1537.

22 We used the experience of our hazards 23 analysis team which included folks experienced in 24 nuclear plant operations and engineering, personnel 25 experienced in reactor and nuclear process safety.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

134 1 Personnel familiar with process hazards 2 analysis and safety analysis modeling and methods, 3 personnel experienced with risk analysis and SHINE 4 system engineers familiar with the details of SHINE's 5 processes.

6 And, this analysis was all done based on our 7 preliminary design information and we do expect to 8 update it with detail design and submit an updated 9 safety analysis with our Operating License Application.

10 We performed qualitative evaluations 11 within categories of accidents and then performed 12 quantitative evaluation on the limiting accidents 13 within those categories.

14 We also postulated a Maximum Hypothetical 15 Accident which is typical of the research reactor 16 community. And that MHA was postulated for both the IF 17 and the RPF. And, I'll discuss both of those on the next 18 couple of slides.

19 Next slide, please?

20 In the IF, the MHA that we postulated was 21 a rupture of the target solution vessel and its 22 secondary vessel, the SASS, that surrounds it. So, 23 both of those vessels rupture, the target solution is 24 undergoing irradiation and spills into the IU cell.

25 We ignore the pool. This is all under NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

135 1 water, if you remember, and if we ignore that presence 2 of the pool so the material just spills and disperses 3 into the air.

4 The high radiation is detected in the IU 5 cell and that initiates isolation of the cell and 6 evacuation alarms for personnel.

7 The exhaust is filtered through HEPA 8 filters and charcoal absorbers and the calculated dose 9 consequences from that event are 3.1 rem TEDE to the 10 worker and 17 millirem at the fence for the public.

11 Next slide, please?

12 In the RPF, the MHA that we postulated was 13 found to have consequences more limiting than the IF 14 MHA, therefore, we designate it the facility MHA. And, 15 that event was the rupture of the noble gas storage tanks 16 in the noble gas removal system.

17 Those tanks store the off gas from those 18 eight irradiation units after the irradiation cycle.

19 It's stored there for decay and we postulated all five 20 of those tanks shown in blue on the figure on the right 21 there, rupture simultaneously and instantaneously.

22 The radiation in the room then initiates 23 confinement of that cell and high radiation alarms to 24 initiate evacuation.

25 Some material bypasses the isolation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

136 1 dampers and exposes and gets into the ductwork and 2 eventually to the public and some material leaks through 3 penetrations and exposes the workers.

4 Next slide, please?

5 The dose consequences for this event were 6 calculated to be 3.6 rem TEDE to the worker and 82 7 millirem at the fence for the public.

8 These consequences were calculated in a 9 conservative manner. There's several significant 10 conservatisms including a simultaneous instantaneous 11 rupture of these five tanks. These will be seismically 12 designed, safety-related tanks with proper isolation 13 between the tanks, so we would not expect multiple tanks 14 to rupture.

15 The tanks, also important to notice, that 16 there's additional isolation dampers in the exhaust 17 ductwork that would trap a large fraction of these 18 radionuclides later on before they get out to the 19 exhaust stack. But, those isolation dampers were not 20 credited in the analysis.

21 So, the dose consequences would be 22 significantly lower than those calculated here.

23 However, the consequences are within the limits of 10 24 CFR 20.1101, 1201 and 1301.

25 And, the figure on the right there shows the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

137 1 dose from the SHINE accident on the left most bar. The 2 center bar is the 10 CFR 20 limit and the bar on the right 3 is the 10 CFR 50.34 dose guidelines for power reactors 4 for comparison.

5 And, that concludes my presentation.

6 CHAIRMAN BURNS: Thank you.

7 Now, we'll ask the staff witnesses to come 8 forward.

9 And, I'll remind the witnesses that they're 10 under oath and I assume you all took the oath earlier 11 today, correct? Yes, and I want to remind you you're 12 under oath and why don't we begin with introductions of 13 the witnesses?

14 MR. MORRISSEY: I'm Kevin Morrissey, Fuel 15 Cycle Safety Review.

16 MR. LYNCH: Steve Lynch, Project Manager, 17 Research and Test Reactors Licensing.

18 MR. STAUDENMEIER: Joe Staudenmeier, 19 Senior Reactor Systems Engineer, Office of Research.

20 CHAIRMAN BURNS: Okay, thanks. Please 21 proceed.

22 MR. LYNCH: So, this panel will discuss the 23 unique accident analyses considerations for the SHINE 24 Utilization and Production Facilities.

25 I'll provide an introduction to the staff's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

138 1 review methodologies. Joe Staudenmeier and Kevin 2 Morrissey will then discuss the specific details of the 3 staff's review and findings.

4 Next slide, please?

5 Based on the anticipated hazards at the 6 SHINE facility, two methodologies were applied to 7 postulated accident scenarios. Postulated accidents 8 at the SHINE facility were evaluated against the 9 radiological exposure limits in 10 CFR Part 20.

10 Therefore, the SHINE workers are limited to 11 a total effective dose equivalent of five rem per year 12 while individual members of the public are limited to 13 100 millirem per year. This is consistent with the 14 exposure limits at existing research reactors.

15 The limiting radiological accident at the 16 SHINE facility is referred to as the Maximum 17 Hypothetical Accident, or MHA.

18 The MHA assumes a failure that results in 19 radiological releases and consequences exceeding those 20 of any postulated credible accident. The radiological 21 consequences resulting from the MHA are acceptable if 22 the resulting doses to workers and the public are less 23 than 10 CFR Part 20 exposure limits.

24 In addition to radiological exposure 25 considerations, the radioisotope production facility NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

139 1 accident analysis used consequence and likelihood 2 criteria for potential accidents resulting in chemical 3 exposures.

4 The staff evaluated SHINE's preliminary 5 radiological and chemical consequence likelihood 6 criteria, safety features and methods of assuring the 7 availability and reliability of safety features.

8 Since the processes and hazards associated 9 with the SHINE radioisotope production facility are 10 similar to those at fuel cycle facilities, the staff 11 determined that SHINE's use of integrated safety 12 analysis methodologies as described in 10 CFR Part 70 13 is an acceptable way of both selecting the MHA and 14 demonstrating safety.

15 Joe Staudenmeier will now discuss the 16 accident analysis considerations for the SHINE 17 irradiation facility.

18 MR. STAUDENMEIER: Thanks, Steve.

19 The SHINE irradiation units operate at low 20 power and low pressure and, therefore, have low forces 21 to drive a radiological release.

22 The target solution vessel and criticality 23 safe dump tank sit in a large pool of water that provides 24 passive decay heat removal.

25 The irradiated target solution and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

140 1 associated fission products and the tritium used in the 2 accelerators are the sources of radioactive material 3 that could be released during an accident.

4 Next slide, please?

5 SHINE has proposed and analyzed a set of 6 postulated accidents that should be representative of 7 the range of events that might happen in an operating 8 facility. Postulated accidents provide insights into 9 the challenges to the safety systems of the facility.

10 SHINE also analyzed how the potential 11 accidents might be prevented or mitigated by 12 administrative controls, engineered safety features 13 and trained personnel actions.

14 The dose consequences were calculated to 15 determine the limiting accident.

16 Next slide, please?

17 A typical SHINE accident scenario involves 18 a radioactive release into the irradiation unit pool or 19 atmosphere. The atmosphere in the irradiation unit is 20 connected by ducts to the ventilation system.

21 There are isolation dampers on the ducts 22 that close in the event of a high radiation signal.

23 Workers are evacuated on a high radiation alarm.

24 The releases reach the outside environment 25 after passing through filters. The calculated NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

141 1 releases are small enough that an acceptable emergency 2 planning zone could be the operational boundary.

3 Next slide, please?

4 The limiting accident for the irradiation 5 facility is a large rupture of one target solution 6 vessel. The target solution and associated fission 7 products are released and no credit is given for fission 8 product scrubbing by the pool.

9 The dose consequences from the limiting 10 accident in the irradiation facility are bounded by the 11 limiting accident in the radioisotope production 12 facility.

13 This accident is a rupture of all noble gas 14 removal system storage tanks where gases produced in the 15 irradiation process are stored while short-lived 16 radioisotopes decay.

17 The calculated total effective dose 18 equivalent is 3.59 rems for workers, 82 millirems for 19 members of the public at the site boundary and less than 20 12 millirems at the nearest residence.

21 The calculated doses meet the 10 CFR Part 22 20 acceptance criteria of five rem for workers and 100 23 millirem for members of the public.

24 Kevin Morrissey will now provide details on 25 the staff's evaluation of SHINE's radioisotope NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

142 1 production facility accident analysis.

2 Next slide, please?

3 MR. MORRISSEY: Thank you, Joe.

4 In order to satisfy the 50.34 requirement 5 that a preliminary safety analysis report must assess 6 the risk to the public health and safety, SHINE 7 performed an Integrated Safety Analysis of the 8 radioisotope production facility.

9 This analysis included radiological and 10 chemical hazard and accident analyses for this portion 11 of the facility.

12 The accident analyses determined the 13 facility hazards that needed to be protected against and 14 help establish the design basis for this area.

15 The purpose of the staff's review was to 16 determine that the proposed design of the radioisotope 17 production facility incorporated adequate capabilities 18 and features to prevent or mitigate potential accidents 19 and to protect the health and safety of the facility 20 workers and the public.

21 The staff's evaluation included review of 22 the following, the integrated safety analysis team, the 23 hazard evaluation process, the integrated safety 24 analysis methodology, the completeness of 25 identification of credible accident sequences, defense NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

143 1 in depth features of the design and safety related 2 design features such as process cells and facility 3 structures.

4 Next slide, please?

5 The staff reviewed multiple accident event 6 types such as radiological accidents including tank or 7 pipe failures and equipment malfunctions, chemical 8 accidents including tank or vessel failures and 9 exothermic reactions, criticality accidents, fires and 10 external events.

11 The review of SHINE's non-radiological 12 accidents included chemical safety related accidents 13 and determination of chemical safety controls.

14 The staff review looked at the equipment 15 and facilities that protect against releases of and 16 chemical exposures to licensed material or hazardous 17 chemicals produced from licensed material.

18 The staff also reviewed chemical risks of 19 plant conditions that affect the safety of licensed 20 material.

21 The staff determined that SHINE's 22 preliminary facility design proposed process 23 operations and safety controls for radiological and 24 chemical safety will perform their expected safety 25 function as intended and, thus, they will be adequate NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

144 1 to protect public health and safety and the environment.

2 The staff concludes that, for the purposes 3 of issuing a Construction Permit, there is reasonable 4 assurance that the proposed preliminary accident 5 analysis of the SHINE facility adequately assessed the 6 risk to public health and safety.

7 The analysis also acceptably supports the 8 determination of the facility hazards in the 9 preliminary safety design including the engineered 10 safety features that protect the health and safety of 11 workers and the public.

12 This concludes the staff remarks for Safety 13 Panel 2. And we are prepared to respond to any 14 questions at this time.

15 CHAIRMAN BURNS: Okay, thank you.

16 What I'd ask the staff witnesses to do is 17 maybe, Mr. Staudenmeier, if you can move to that seat, 18 move a little closer to the secretary and Mr. Morrissey 19 and Mr. Lynch and this way then we can all see each 20 other -- good visual from there and maybe just a little 21 bit closer to the secretary. That's good, that's good.

22 I believe we start the questioning, 23 Commissioner Baran.

24 COMMISSIONER BARAN: Thanks.

25 Steve and Joe, I wanted to -- now you're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

145 1 very far apart -- but, I wanted to ask you about the 2 Maximum Hypothetical Accident for the irradiation 3 facility.

4 As you mentioned, this involves failure of 5 one of the eight irradiation units. Now, in response 6 to pre-hearing questions five and six, the staff stated 7 that the irradiation units have been designed to 8 withstand any events that could cause multiple units to 9 fail simultaneously.

10 That's a pretty strong statement and I 11 wanted to give you a chance to talk to us about how you 12 reached that conclusion.

13 MR. STAUDENMEIER: Okay. As you said, the 14 units were isolated from each other, they're in robust 15 concrete shielding structures and they are designed to 16 withstand any design basis event like seismic or other 17 loadings on the system. And, there's no real way for 18 a failure in one to trigger failures in others or a chain 19 reaction.

20 COMMISSIONER BARAN: So, the staff looked 21 at tornados, earthquakes, floods, fires, aircraft 22 impacts, loss of offsite power and the staff concluded 23 that none of these events could cause more than one 24 irradiation unit to fail, is that right?

25 MR. STAUDENMEIER: Well, in terms of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

146 1 aircraft impact, the smaller aircraft that the type that 2 land at that airport, I know the facility is designed 3 to withstand impacts from those.

4 I don't think a large aircraft crash was 5 within the design basis of the facility.

6 COMMISSIONER BARAN: Okay, so with respect 7 to design basis events of those types?

8 MR. LYNCH: Yes, that is correct.

9 COMMISSIONER BARAN: Okay. Are there any 10 other kind of beyond design basis events besides larger 11 aircraft that you particularly have in mind that could 12 be an issue?

13 MR. LYNCH: Not at this time, no.

14 COMMISSIONER BARAN: Okay. And, you 15 alluded to this a little bit, Joe, but are there -- could 16 any of the common fill drain or off gas line shared by 17 the eight units result in an accident worse than the 18 Maximum Hypothetical Accident because of a common mode 19 failure?

20 MR. STAUDENMEIER: No, not that I'm aware 21 of. I mean, there's one common mode failure for cooling 22 to the TOGS system, I think, in long term, but the cells 23 would be isolated by that time and SHINE was going to 24 look at that for, I think they had a survival time of 25 four hours maybe for power lasting and they were going NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

147 1 to look at that in the Operating License Review.

2 COMMISSIONER BARAN: Okay. Well, let me 3 just give SHINE a chance if you wanted to add anything 4 on the Maximum Hypothetical Accident for the 5 irradiation units that the staff didn't cover.

6 MR. VAN ABEL: We did look at potential for 7 other events involving multiple units and we didn't 8 identify any potential events that would be worse than 9 the Maximum Hypothetical Accidents.

10 COMMISSIONER BARAN: Okay, thanks.

11 Pre-hearing question 29 asked about safety 12 features for the transfer of the target solution to the 13 radioisotope production facility after irradiation.

14 I'd like to ask the staff, what criticality 15 risks exist when the target solution is transferred and 16 how is that risk mitigated?

17 MR. LYNCH: Yes, I think Chris Heysel did 18 a review on engineered safety features. If you would 19 like to say a few words on that?

20 CHAIRMAN BURNS: Again, identify yourself 21 and confirm that you were previously put under oath.

22 MR. HEYSEL: For the record, my name is 23 Chris Heysel, I'm a Consultant with ISL. And, I did 24 take the oath earlier.

25 CHAIRMAN BURNS: Please be seated.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

148 1 MR. HEYSEL: The engineering safety 2 features are integral to both the IUs and the RPFs. So, 3 the both passive and active features will provide the 4 engineering safety features to mitigate normal and 5 upset conditions.

6 The design of those features will control 7 a criticality accident due to the geometries associated 8 with them.

9 COMMISSIONER BARAN: And, will the 10 criticality accident alarm system include coverage for 11 the entire path that the target solution travels during 12 transfer?

13 MR. HEYSEL: I am not the correct witness 14 to talk about the criticality alarm system.

15 COMMISSIONER BARAN: Okay.

16 Very quickly, anyone on the staff would 17 care to answer that?

18 MR. LYNCH: Chris Tripp, would you like to 19 discuss the criticality accident alarm system and the 20 areas of coverage?

21 COMMISSIONER BARAN: Just briefly.

22 CHAIRMAN BURNS: Identify yourself.

23 MR. TRIPP: Chris Tripp and I did take the 24 oath.

25 Yes, we don't have the design details of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

149 1 criticality alarm system in detail. However, SHINE has 2 not identified any areas where they'd be taking 3 exceptions.

4 So, anywhere there is special nuclear 5 material present, we understand that they would have 6 coverage of those areas.

7 COMMISSIONER BARAN: Okay, great. Thank 8 you.

9 Thanks, Mr. Chairman.

10 CHAIRMAN BURNS: I had a couple of 11 questions in terms of the review and the accident 12 analysis.

13 What are, and I think SHINE and/or the staff 14 can address this, what are the most significant natural 15 hazards that you had to focus your design on?

16 MS. KOLB: I guess we can go first.

17 So, we looked at natural hazards involving 18 flooding, as I spoke about earlier today. We looked at 19 the design basis aircraft, that's not really a natural 20 hazard, that's an external event.

21 We looked at the tornados, historical 22 maximum tornados. We used guidance from Regulatory 23 Guide, I believe it's 1.76 for the -- that's used for 24 power reactors for the spectrum and the wind speeds for 25 tornados.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

150 1 We looked at tornado missiles. Anything 2 else I'm missing? I mentioned flooding.

3 CHAIRMAN BURNS: Okay. And, staff, do you 4 want to add on to that?

5 MR. LYNCH: The one other thing that SHINE 6 did look at this as well in addition to staff was the 7 rain-snow load on the facility as well as an external 8 event.

9 CHAIRMAN BURNS: In terms of the roof of the 10 building?

11 MR LYNCH: Yes, yes.

12 CHAIRMAN BURNS: Okay.

13 MR. LYNCH: Yes.

14 CHAIRMAN BURNS: Okay.

15 There's just -- actually, part of our 16 discussion focused on not only radiological hazards, 17 but chemical hazards and, I think in the description of 18 the facility, for example, sulfuric acid is used in part 19 of the process.

20 What are the significant potential 21 chemical hazards that are involved with the facility?

22 MR. VAN ABEL: For SHINE.

23 We looked at a variety of chemical hazards 24 in the facility. We do have sulfuric acid, nitric acid, 25 other acids and bases.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

151 1 We identified 24 chemicals of concern that 2 we use throughout the process and 11 of them were 3 explicitly modeled because of their -- either their 4 toxicity, their dispersibility or inventory. And that 5 includes things like the acids I mentioned, calcium 6 hydroxide, caustic soda, ammonium hydroxide, 7 N-dodecane, potassium permanganate, tributyl phosphate 8 which is part of the UREX process and uranyl nitrate and 9 a couple of proprietary chemicals as well.

10 CHAIRMAN BURNS: Okay. From the -- go 11 ahead, Mr. Lynch.

12 MR. LYNCH: Yes, I would just say as far as 13 the chemical hazards and concern, the staff is expecting 14 hazardous chemicals to be in very small quantities at 15 the facility.

16 The only chemicals that could exceed large 17 quantities which we're considering to be greater than 18 1,000 pounds would be nitric acid or sulfuric acid.

19 And, there are a number of processes that we are 20 evaluating that involve these chemical hazards and this 21 includes the preparation of the target solution vessel, 22 the radioisotope production, extraction and 23 purification system, target solution clean up and any 24 waste operations.

25 CHAIRMAN BURNS: Okay. In terms of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

152 1 control of those types of hazards, do we look primarily 2 to the regulatory footprint or authority of other 3 agencies or how is that integrated in terms of what the 4 staff would evaluate in terms of acceptability for both 5 the Construction Permit, but looking forward, if we came 6 to a point of an Operating License, what would we do?

7 MR. MORRISSEY: Well, typically, we 8 evaluate chemical hazards in Part 70 under 70.61. So, 9 we use that and SHINE, that is one acceptable way of 10 doing things and SHINE preferred to take that way.

11 CHAIRMAN BURNS: Okay.

12 MR. MORRISSEY: And so, 70.61 provides 13 guidance through 1520 on, you know, how to do chemical 14 safety evaluations.

15 CHAIRMAN BURNS: Okay. And, just to 16 confirm my understanding on the Maximum Hypothetical 17 Accident that was described is, I understand, or the 18 slides in the presentation, in that event, the 19 expectation would be that a worker dose would be less 20 than the normal occupational dose that is permitted 21 under Part 20, is that correct? I thought I heard 22 something like 3 point X rem.

23 MR. VAN ABEL: Yes.

24 CHAIRMAN BURNS: Okay.

25 MR. VAN ABEL: That's correct.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

153 1 CHAIRMAN BURNS: And then, the site 2 boundary dose to the public would be 82 millirem as 3 opposed to the 100 millirem? So, then what we're -- at 4 least from our understanding at this point for purposes 5 of Construction Permit, is you have doses that are 6 actually below what we'll call normal dose limitations?

7 MR. LYNCH: Yes, that is correct.

8 CHAIRMAN BURNS: Okay.

9 There was a comment with respect to, and 10 again, looking forward, we're not deciding emergency 11 preparedness requirements in this context today, but 12 there was a comment made and I don't -- I think it may 13 have been one of the staff witnesses, but it may have 14 been SHINE, with respect to the size the -- or the, I 15 guess, not size but, perhaps, boundary of an emergency 16 planning zone was described as the operational 17 boundary.

18 Can you describe for me what that means?

19 Does that mean the building or does that mean the 20 owner -- what I would call the owner controlled area?

21 MR. LYNCH: Yes, the operational boundary 22 would be the building itself. And, just to clarify, 23 that is something the staff is still evaluating as to 24 what in the Operating License.

25 CHAIRMAN BURNS: No, I understand, but I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

154 1 appreciate that clarification.

2 That's all I have.

3 Commissioner Svinicki?

4 COMMISSIONER SVINICKI: Thank you for your 5 presentations on this panel which were principally 6 regarding Chapter 13 Accident Analysis.

7 In my preparation between reviewing the 8 record itself and the supplements given in the response 9 to pre-hearing questions, I found there to be a very 10 complete and exhaustive discussion of the Maximum 11 Hypothetical Accident. So, I was satisfied with 12 answers to my questions on those points.

13 So, I do have two questions that relate to 14 Chapters 11 and 12. And, Chapter 11 addresses waste 15 management issues.

16 This is for, I think both of my questions 17 will be for the Applicant witnesses.

18 SHINE has indicated that greater than Class 19 C low level waste would be generated as a result of 20 operating the facility, is that correct?

21 MS. KOLB: Yes, we do have that in our PSAR.

22 COMMISSIONER SVINICKI: Okay. So, my 23 question is, if there is no national disposal pathway 24 for your greater than Class C waste, would you have 25 adequate ability to store that on your site for the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

155 1 lifetime of the operations of the facility?

2 MS. KOLB: Before I answer that --

3 COMMISSIONER SVINICKI: If not, what is 4 your other alternative plan?

5 MS. KOLB: So, our designations of greater 6 than Class C waste are two small waste streams and that's 7 based on our preliminary design and some conservative 8 assumptions.

9 It's possible when we refine the design 10 that we may limit or eliminate that waste stream but, 11 as it stands, we've had discussions with some licensed 12 disposal facilities that have the ability to store 13 greater than Class C waste.

14 If SHINE did not have a commercial path, 15 either at Waste Control Specialists or some other 16 commercial disposal or storage facility, then the 17 provision of the American Medical Isotope Production 18 Act has a provision to accept the wastes from medical 19 isotope productions and that's what we would --

20 COMMISSIONER SVINICKI: And that --

21 MS. KOLB: And that would be our fallback 22 position.

23 COMMISSIONER SVINICKI: And that 24 provision in the Act is for the Department of Energy or 25 U.S. Government to take that waste?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

156 1 MS. KOLB: The Department of Energy, 2 that's correct.

3 COMMISSIONER SVINICKI: Okay, thank you.

4 And then Chapter 12 is conduct of 5 operations, but broadly, as SHINE looks to the future 6 and the possible need for qualified operators, very 7 conceptually, what do you envision as the skills, 8 knowledge and abilities of the types of experience that 9 a qualified operator for this type of facility would 10 have? Is it someone who has operated power reactors or 11 research and test reactors? Would that be in general 12 the requisite skill set or is it only requiring some sort 13 of smaller set of knowledge skills and abilities?

14 MR. COSTEDIO: I mean, certainly, we'd 15 entertain the hiring folks with prior power reactor 16 experience and that would be good. Also, nuclear Navy 17 and engineers out of college.

18 We plan on having a training program in 19 accordance with NUREG-1478 for research and test 20 reactors, that's how they license their operators.

21 We do have to do some work, you know, with 22 the staff on that to line that up with what we do. But, 23 we certainly plan on having a rigorous SAT-based, you 24 know, training process with exams and very, very similar 25 to what the research and test reactors do now.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

157 1 COMMISSIONER SVINICKI: Would you 2 envision having any sort of partnership with local maybe 3 technical colleges or others to develop a kind of a 4 qualified worker base for this facility going forward?

5 Is that something you've thought about?

6 MR. COSTEDIO: Yes, with Blackhawk 7 College, we've talked with them.

8 Do you have more?

9 MR. HENNESSY: We have been working with 10 the local technical colleges. There's one up in 11 Northeast Wisconsin which is in partnership with the one 12 down by Janesville that has done a lot of training for 13 RP personnel to work at the power plants that are up 14 there.

15 And so, they've been looking at 16 transferring those programs down to the Janesville area 17 and we expect that will be very useful to us to help find 18 good staff to staff our facility.

19 COMMISSIONER SVINICKI: Okay, thank you.

20 Thank you, Mr. Chairman.

21 CHAIRMAN BURNS: Thank you.

22 Commissioner Ostendorff?

23 COMMISSIONER OSTENDORFF: Thank you, Mr.

24 Chairman.

25 I'm going to start off with the Applicant, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

158 1 please.

2 I recognize the unique nature of SHINE that 3 weve conceptually looked at today. Is there anything 4 in the radiation detection arena as far as equipment 5 monitoring instrumentation that you would characterize 6 as never tried before or first-of-a-kind engineering or 7 first-of-a-kind instrumentation?

8 MR. VAN ABEL: No -- we have various 9 radiation area monitors in the facility, continuous air 10 monitors, standard off-the-shelf type technology.

11 We're looking at neutron flux detectors to 12 monitor the reactivity and the neutron population in the 13 TSV during irradiation.

14 And, we're talking to existing vendors who 15 supply research reactors with that technology and it's 16 all within normal --

17 COMMISSIONER OSTENDORFF: So, as far as 18 neutron detectors, you expect to be able to use some 19 technology that's already on the market for that?

20 MR. VAN ABEL: Oh, yes, yes, that is 21 correct.

22 COMMISSIONER OSTENDORFF: Okay.

23 Real quick, did the staff see any 24 challenges in this area for either radiation protection 25 or detection device approaches?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

159 1 MR. LYNCH: As of now, we have not.

2 COMMISSIONER OSTENDORFF: Okay.

3 All right, let me go back to the Applicant 4 real quick.

5 On your slide four, several times there's 6 reference to the isolation dampers. I know dampers 7 seem pretty straightforward, but dampers can be 8 complex. Are these manually operated? Are they 9 operated by some solenoid or hydraulic system or can you 10 talk about, in an accident scenario, how they'd be 11 operated?

12 MR. VAN ABEL: We haven't selected the 13 dampers yet. They would not be manually operated, 14 they'd be operated by some actuation mechanism, 15 hydraulic or pneumatic.

16 We've looked at vendors that supply these 17 for the nuclear industry and there are many choices 18 available that we think will meet our criteria, but they 19 would be automatic actuated by the safety systems and 20 they would be fail close so their fail position would 21 be closed if you lose offsite power, they would close 22 automatically.

23 COMMISSIONER OSTENDORFF: And the use of 24 the word redundant in front of isolation dampers, does 25 that mean there's more than one damper in the flow path NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

160 1 of the ventilation?

2 MR. VAN ABEL: It means -- yes, nominally 3 there would be two dampers at every place that you need 4 an isolation capability.

5 COMMISSIONER OSTENDORFF: All right, 6 thank you.

7 I have no further questions.

8 CHAIRMAN BURNS: I was about to -- I did 9 this last time, last year, I always went to Commissioner 10 Baran again, to redo a round, but I take it without 11 anything else, we'll dismiss this panel.

12 Thank you for your testimony and we'll call 13 up the environmental panel.

14 (Whereupon, the above-entitled matter went 15 off the record at 2:06 p.m. and resumed at 2:08 p.m.)

16 CHAIRMAN BURNS: Well, thank you, again.

17 And, we'll, again, with this panel, we'll 18 have the testimony of the Applicant and then the staff 19 testimony, then proceed to questioning.

20 Again, I remind all the witnesses that they 21 remain under oath and I'll ask you, when you start again 22 and ask you to introduce yourselves, first for the SHINE 23 witnesses.

24 MS. PITAS: Certainly. My name's Katrina 25 Pitas. I'm the Vice President of Business Development NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

161 1 for SHINE.

2 CHAIRMAN BURNS: Okay.

3 MR. HENNESSY: Bill Hennessy, Manager of 4 Engineering for SHINE.

5 MS. KOLB: Catherine Kolb, Engineering 6 Supervisor.

7 MR. KRAUSE: I'm Tim Krause. I'm an 8 Environmental Coordinator for the project.

9 CHAIRMAN BURNS: Okay. And, why don't you 10 all start?

11 MS. PITAS: Thank you.

12 So, I'm going to give the environmental 13 overview for SHINE today.

14 Next slide, please?

15 On this first slide, you will see some 16 pictures of some of the site characterization work that 17 was done. We began that work back in October of 2011 18 at the Janesville site which was chosen for the SHINE 19 facility.

20 And, we did that site characterization work 21 to develop the environmental report which followed the 22 final Interim Staff Guidance augmenting NUREG-1537.

23 Next slide, please?

24 This table shows the structure and the 25 content of the Environmental Report. After NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

162 1 introducing the project, the Environmental Report goes 2 on to discuss the proposed action. It then goes into 3 a detailed description of the affected environment and 4 the resources of the chosen site, Janesville.

5 Then, it goes on to analyze both the impacts 6 and the benefits of the SHINE technology on the chosen 7 site.

8 And then, it compares the impacts of the 9 SHINE technology at the Janesville site with the impacts 10 of the no-action alterative, what the impacts of the 11 SHINE technology would be at two alternative sites, 12 Chippewa Falls and Stevens Point.

13 And then, it looks at the impacts of two 14 alternative technologies.

15 It then goes on to discuss the conclusions 16 reached by the report.

17 Next slide, please?

18 The field investigations we needed to do to 19 gather the information to complete the environmental 20 report were thorough and very extensive.

21 In addition to a Phase I environmental site 22 assessment and general site reconnaissance, the 23 geotechnical investigation consisted of 15 soil 24 borings, one of which was used for seismic 25 characterization, four of which were converted to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

163 1 groundwater monitoring wells.

2 A Phase I archaeological investigation, a 3 baseline visual assessment and a wetland delineation 4 were all performed as well as ecological investigations 5 that consisted of quarterly field surveys over the 6 course of one year. Those looked at both aquatic 7 ecology and terrestrial ecology.

8 And, monthly ground and surface water 9 monitoring that looked at both water quality and water 10 levels.

11 Next slide, please?

12 The context for our data acquisition varied 13 depending on which resource was being analyzed. Many 14 of the investigations looked just at the SHINE parcel 15 itself which, as has been mentioned, is a 91-acre parcel 16 on the south side of Janesville, Wisconsin.

17 Some of the investigations looked a little 18 bit broader at the project area which we consider to be 19 the one mile radius from the site center point.

20 And then, other investigations looked at 21 the entire region surrounding the SHINE site, often up 22 to five miles in all directions from the center point.

23 And then, for some of the resources like 24 geology and air quality, we looked at even larger 25 contexts as was appropriate to the resource.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

164 1 For socio-economic impacts, we looked at 2 what is known as the region of influence. That 3 corresponds to the area that incurs the greatest impacts 4 to community services that result from the SHINE 5 facility and the people who work at the SHINE facility.

6 We determined that to be Rock County, Wisconsin.

7 Next slide, please?

8 We also conducted a number of consultations 9 in preparation for the environmental report.

10 We talked to the City of Janesville, Rock 11 County, the Wisconsin Department of Natural Resources, 12 the Wisconsin State Historic Preservation Office, the 13 Wisconsin Department of Transportation, the U.S. Fish 14 and Wildlife Service, the Federal Aviation 15 Administration, the Bureau of Indian Affairs and we also 16 contacted 13 Native American Tribes including two 17 Tribes located within the State of Wisconsin and 11 18 Tribes that were non-Wisconsin Tribes.

19 Next slide, please?

20 In addition to the impacts of constructing 21 and operating the SHINE facility at the Janesville site, 22 SHINE analyzed two alternative sites and the no-action 23 alternative.

24 The SHINE project, as has been discussed, 25 results in a number of local, national and global NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

165 1 benefits. These include the socio-economic benefits 2 for the local community consisting of tax benefits and 3 increased job opportunities.

4 The SHINE project also lends support for 5 U.S. Government policies to encourage domestic 6 production of medical isotopes and nonproliferation.

7 But, most of all, the SHINE project results 8 in health benefits from a reliable, stable supply of 9 technetium-99m, for patients around the globe.

10 So, in light of these benefits, the 11 no-action alternative is not preferable to the 12 construction and operation of the SHINE facility.

13 Although the no-action alternative would 14 avoid the environmental impacts associated with the 15 SHINE project, because all of these impacts are small 16 for the SHINE technology, avoiding these impacts is not 17 significant.

18 And, the no-action alternative would not 19 impart the important benefits that I mentioned before.

20 Looking at the two alternative sites, 21 Chippewa Falls and Stevens Point, neither alternative 22 site would reduce or avoid adverse impacts as compared 23 with the SHINE site.

24 As shown in this table, the Janesville site 25 is the preferred site from an environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

166 1 perspective, given that it has small impacts to all 2 resource categories while the alternatives had moderate 3 impacts to some resource categories during 4 construction.

5 Next slide, please?

6 SHINE also analyzed two -- the 7 environmental impacts of two alternative technologies, 8 both the linear accelerator technology that would be 9 creating moly-99 from enriched or natural molybdenum 10 targets and a low enriched uranium aqueous homogeneous 11 reactor.

12 Both of these technologies are considered 13 reasonable alternatives to the SHINE technology for the 14 Janesville site from an environmental perspective.

15 But, neither of the alternative technologies would 16 reduce or avoid adverse impacts as compared with the 17 SHINE technology.

18 Next slide, please?

19 In mid-2013, the NRC staff conducted an 20 environmental site audit. SHINE gave the staff 21 presentations on the SHINE technology and our site 22 selection process.

23 The staff then made a number of visits to 24 places of interest in the community. Those included 25 the Janesville site and the surrounding area. We went NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

167 1 on a driving tour of about 4.4 miles around the site.

2 We visited the Rock River. We visited the 3 sites that were used for sampling along the nearby 4 unnamed tributary. We visited the Janesville 5 Wastewater Treatment Facility which included a look at 6 the outfall structure to the Rock River.

7 And, we looked at both alternative sites.

8 We traveled both to Stevens Point and to Chippewa Falls.

9 Next slide, please?

10 SHINE believes the relationships between 11 the company, the City of Janesville and the State of 12 Wisconsin are incredibly important and we worked very 13 hard to build and continuously strengthen those 14 relationships via a policy of transparency and frequent 15 engagement.

16 Supporting these principles, we ensure a 17 minimum of four public meetings with the community per 18 year, as I had mentioned earlier. And, actually, the 19 most recent of those happened on December 9th.

20 As a result of these activities and these 21 efforts, we have a relationship with the community 22 that's based on trust, mutual respect and, I believe, 23 genuine enthusiasm for the SHINE project.

24 Next slide, please?

25 In conclusion, the SHINE environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

168 1 review was conducted pursuant to 10 CFR Part 51 and is 2 adequate. The requirements of Sections 102(2)(A), (C) 3 and (E) of the National Environmental Policy Act have 4 been satisfied and SHINE's weighing and balancing of the 5 environmental, technical and other costs and benefits 6 of the SHINE facility supports issuance of the 7 Construction Permit.

8 Thank you.

9 CHAIRMAN BURNS: Okay, thank you.

10 We'll proceed now with the staff testimony 11 and I'd ask the staff witnesses to identify themselves 12 and then you can proceed.

13 MS. MARSHALL: My name is Jane Marshall.

14 I'm the Deputy Director for the Division of License 15 Renewal in the Office of Nuclear Reactor Regulation.

16 MR. WRONA: I'm David Wrona, the Chief of 17 the Environmental Review Branch in the Office of NRR.

18 MS. MOSER: My name is Michelle Moser.

19 I'm the Environmental Project Manager in NRR.

20 CHAIRMAN BURNS: Okay, thank you.

21 Proceed.

22 MS. MARSHALL: Okay, thanks.

23 If I can have -- you've got my slide, thank 24 you.

25 Good afternoon. I'm Jane Marshall and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

169 1 with me today to discuss the environmental review of the 2 SHINE facility are Dave Wrona and Michelle Moser.

3 Next slide, please?

4 As I mentioned during my presentation 5 earlier this morning, part of the staff's review of the 6 SHINE Construction Permit Application included an 7 environmental review which was conducted in parallel 8 with the safety review that you heard about earlier 9 today.

10 The staff performed the environmental 11 review in accordance with the National Environmental 12 Policy Act of 1969, commonly referred to as NEPA.

13 In doing it's NEPA review, the staff 14 followed the environmental review process for preparing 15 an Environmental Impact Statement, commonly referred to 16 as an EIS, as described in 10 CFR Part 51 and in the 17 Interim Staff Guidance augmenting NUREG-1537.

18 The following presentations provide an 19 overview of the environmental review for the SHINE 20 Application while highlighting the unique aspects of 21 this review.

22 The three novel issues that we will 23 highlight today include the staff's decision to prepare 24 an EIS, the inclusion of the Department of Energy as a 25 cooperating Agency and the NRC staff's analysis to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

170 1 determine the range of reasonable alternatives analyzed 2 in the EIS.

3 And now, I turn it over to Dave Wrona.

4 MR. WRONA: Thank you, Jane.

5 One of the first steps in the environmental 6 review process was determining the appropriate 7 methodology for the environmental review and the level 8 of detail for staff findings.

9 Environmental reviews for licensing 10 actions fall into one of three categories, those 11 identified as categorical exclusions and not requiring 12 further evaluation, those requiring the preparation of 13 an environmental assessment, commonly referred to as an 14 EA and those requiring the preparation of an EIS.

15 Licensing actions that require an EIS are 16 described in 10 CFR 51.20. The proposed issuance of a 17 Construction Permit for a medical radioisotope 18 production facility is not specifically listed in 10 CFR 19 51.20.

20 Such licensing actions would require an EA 21 or an EIS, depending on project-specific activities and 22 site-specific conditions that could impact the actions 23 potential to significantly affect the quality of the 24 human environment.

25 After reviewing SHINE's environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

171 1 report, the staff made a project-specific determination 2 that an EIS would be appropriate to assess the 3 environmental impacts of the proposed 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 unique 8 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.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

172 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 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 written 17 letters from members of the public, the Wisconsin 18 Department of Natural Resources, the U.S. Environmental 19 Protection Agency and the Forest County Potawatomi 20 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

173 1 alternative sites and technologies.

2 The staff responded to all comments 3 received during the scoping period in a Scoping Summary 4 Report. It included relevant information from in scope 5 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 NRC 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 unique 19 aspect of this review. The coordination with DOE was 20 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 to 25 the maximum extent practicable that environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

174 1 reviews for facilities to produce medical radioisotopes 2 are complimentary and not duplicative.

3 Therefore, NRC and DOE developed a 4 Memorandum of Agreement to make effective and efficient 5 use of federal resources during the review of the SHINE 6 Construction Permit Application.

7 The goal of the agreement was to develop a 8 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 cooperating 12 agency for developing the EIS for the proposed SHINE 13 facility.

14 Under NEPA, the lead agency, or NRC in this 15 case, has the primary role in preparing the EIS while 16 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 the site, considered scoping comments 24 and 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

175 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 small 21 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

176 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 1,000 9 trips per day from construction activities and up to 580 10 trips a day from decommissioning activities at the 11 proposed SHINE site would result in increased traffic 12 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 hours0.667 days <br />0.0952 weeks <br />0.0219 months <br /> 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.

25 The NRC implements this requirement NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

177 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 the 11 environmental impacts of the no-action alternative or 12 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.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

178 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 a 6 large number of potential alternatives exist.

7 In such situations, NEPA only requires that 8 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.

25 The staff also selected new technologies NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

179 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 publicly 19 available documents that describe the air emissions, 20 estimated dose exposures, water use, building heights 21 and footprints and other environmental parameters to 22 assess the environmental impacts for each alternative 23 technology.

24 DOE's environmental assessment for the 25 North Star facility provided sufficient environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

180 1 data to conduct a meaningful, in depth analysis for the 2 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 site, 24 the impacts to all resource areas, expect for traffic, 25 would be small. The impacts to traffic would be small NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

181 1 to moderate because of the noticeable increase in 2 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 to 10 moderate at both Chippewa Falls and Stevens Point in 11 part because the nearest resident would be closer than 12 at the Janesville site and, therefore, the noise would 13 be more audible to the closest resident.

14 The impacts to visual resources would be 15 small to moderate at the Stevens Point site because the 16 site and much of the surrounding area is forested. In 17 clearing onsite forests during construction would 18 increase the visibility of the new facility, especially 19 in contrast to the surrounding forested area.

20 Similar to the proposed Janesville site, 21 the impacts at both Chippewa Falls and Stevens Point 22 would be small to moderate for traffic.

23 Therefore, the staff concluded that the 24 Janesville site would be the environmentally preferable 25 alternative.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

182 1 Under the no-action alternative, no 2 changes would occur to the proposed SHINE site in 3 Janesville, Wisconsin. The site would remain zoned for 4 light industrial use. Therefore, impacts on all 5 resource areas would be small.

6 However, the no-action alternative does 7 not meet the stated purpose and need to provide a medical 8 radioisotope production option that could help meet the 9 need for a domestic source of molybdenum-99.

10 Slide 13, please?

11 In terms of the benefits considered, the 12 proposed action would result in several societal, 13 medical and economical benefits.

14 For example, the proposed action is in 15 accordance with U.S. policy to ensure a reliable supply 16 of medical radioisotopes while minimizing the use of 17 highly enriched uranium.

18 In addition, the production of 19 molybdenum-99 would increase availability of medical 20 radioisotopes for U.S. public health needs.

21 And, lastly, constructing and operating 22 the proposed SHINE facility would result in economic 23 benefits such as tax revenue and employment 24 opportunities to communities located near the 25 Janesville site.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

183 1 Based on the small environmental impacts 2 associated with the proposed SHINE facility at the 3 Janesville site and the benefits to the U.S. medical 4 community, the efforts to support U.S. policy to produce 5 a domestic supply of molybdenum-99 using low enriched 6 uranium and the economic tax and employment benefits 7 associated with construction and operation of the SHINE 8 facility, the staff determined that the benefits 9 outweigh the small environmental costs.

10 Next slide, please?

11 In addition to NEPA, the NRC may address 12 other regulatory requirements within its EIS. For 13 example, the staff conducted a review of potential 14 impacts to the threatened and endangered species as 15 required by the Endangered Species Act.

16 Under this Act, the staff must consult with 17 the U.S. Fish and Wildlife Service to determine whether 18 threatened and endangered species could occur on the 19 proposed site and, if so, if the proposed action would 20 affect such species.

21 The proposed action would have no effect on 22 threatened and endangered species because the proposed 23 site is primarily an agricultural field and does not 24 provide suitable habitat for any threatened or 25 endangered species.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

184 1 In a letter to the NRC, the U.S. Fish and 2 Wildlife Service stated that no federally listed 3 proposed or candidate species would be expected within 4 the project area and no further action is required by 5 the Endangered Species Act if SHINE constructs the 6 proposed facility on the Janesville site.

7 Under Section 106 of the National Historic 8 Preservation Act, the staff is required to first 9 determine whether historic properties would be affected 10 by the proposed action.

11 If historic properties would be affected, 12 then the staff determines whether the effects would be 13 adverse.

14 The proposed action would have no impact on 15 known historic and cultural resources because the staff 16 did not identify any historic and cultural resources 17 eligible for protection under the National Historic 18 Preservation Act.

19 In July 2015, the Wisconsin Historical 20 Society concurred with the staff's determination that 21 no historic properties would be affected.

22 Slide 15, please?

23 On May 11, 2015, staff issued the draft EIS 24 for public comment. During this comment period, the 25 staff requested input from the public and other federal, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

185 1 state and local agencies regarding the data analyses and 2 conclusion in the draft EIS.

3 During this comment period, the NRC held 4 two public meetings in Janesville, Wisconsin. One 5 member of the public provided an oral statement at the 6 meetings.

7 In addition, the staff received eight 8 written letters from members of the public, Wisconsin 9 Department of Natural Resources, the U.S. Environmental 10 Protection Agency, Peoria Tribe of Indians of Oklahoma 11 and from SHINE.

12 In-scope comments addressed a variety of 13 environmental issues including the potential impacts 14 from accidents due to aircrafts, storage of radioactive 15 waste, greenhouse gases and climate change, potential 16 contamination to nearby agricultural lands and 17 alternative sites and technologies.

18 The staff responded to all comments in the 19 final EIS which was published on October 16, 2015. The 20 staff revised the final EIS based on the in-scope 21 comments and based on newly available information since 22 the publication of the draft EIS.

23 Next slide, please?

24 In accordance with 10 CFR 51.105(a), the 25 staff weighed the environmental, economical and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

186 1 technical costs and benefits for the proposed action, 2 alternative sites and the alternative technology and 3 the no-action alternative.

4 Based on the small environmental impacts 5 associated with the proposed SHINE facility at the 6 Janesville site and the societal, medical and economic 7 benefits associated with the proposed SHINE facility, 8 the staff determined that the benefits outweigh the 9 small environmental costs.

10 Therefore, in the EIS, the staff recommends 11 the issuance of the Construction Permit.

12 Slide 17, please?

13 The issuance of a Construction Permit is a 14 separate licensing action from the issuance of an 15 Operating License. If the NRC issues a Construction 16 Permit, 10 CFR part 50 requires that SHINE submit a 17 separate Application for an Operating License.

18 If SHINE were to submit an Application for 19 an Operating License for a production or utilization 20 facility, the staff would prepare a supplement to the 21 EIS in accordance with 10 CFR 51.95(b).

22 The supplement to the final EIS would 23 update the environmental review by discussing issues or 24 topics not included in the final EIS and any new and 25 significant information regarding matters discussed in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

187 1 the final EIS.

2 The staff would follow the environmental 3 review process outlined in 10 CFR Part 51 in preparing 4 the supplement to the EIS, including scoping, 5 requesting comments on the EIS and updating the 6 supplement to the EIS based on public comments received.

7 This concludes the staff's remarks in the 8 Environmental Panel. We are prepared to answer any 9 questions you may have.

10 CHAIRMAN BURNS: Okay. And, what I might 11 ask you to do is do a little bit of shuffle again so we 12 can all see.

13 And, I'll start off with questions.

14 I found it interesting, Mr. Wrona, that 15 there was a -- your testimony discussed the question of 16 whether or not an Environmental Impact Statement would 17 have been prepared for this site.

18 Was there really a serious question that 19 there would not have been an EIS for a project of this 20 kind?

21 For example, if this were a research 22 reactor, would that have normally required an EIS?

23 MR. WRONA: The issuance of a Construction 24 Permit for a research reactor would not, again, be in 25 10 CFR Part 51.20 as required to have an EIS issued.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

188 1 We look at these on a case by case basis.

2 So, it would depend on what the proposed action is and 3 what is going on at the site where they're proposing.

4 CHAIRMAN BURNS: Okay. So, in sum, you 5 would say that the two major factors or the major factors 6 that led the staff to conclude that an EIS was an 7 appropriate means of addressing our NEPA obligation 8 were what?

9 MR. WRONA: It was, for the SHINE case, the 10 unique first-of-a-kind application was one of the 11 things and the main thing that led us to develop an EIS 12 for SHINE. That was pretty much the main issue for 13 development of an EIS.

14 CHAIRMAN BURNS: Okay, all right, thanks.

15 I think, Ms. Moser, you, in discussing the 16 alternative technologies, one thing I think I heard you 17 say is that the staff excluded from consideration as 18 alternative technologies, technologies used outside of 19 the United States.

20 I'm trying to understand that because what 21 that includes, is that basically using what is currently 22 the source, which are research reactors?

23 MS. MOSER: Correct. We excluded that 24 from further detailed studies.

25 CHAIRMAN BURNS: Okay, so there isn't some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

189 1 other newer technology that's being considered at this 2 point? I'm just trying to understand the scope of 3 what -- it was interesting how you said that.

4 So, basically, what it was, you were not 5 considering production in a research reactor such as is 6 currently conducted is what you're saying?

7 MS. MOSER: Correct, outside of the -- yes, 8 that is currently occurring outside of the United States 9 and we eliminated that from further study within our 10 alternative technology analysis.

11 CHAIRMAN BURNS: Okay.

12 One of the things you also just spoke to in 13 terms of describing the comments was comments that were 14 within scope. I presume were some of the comments what 15 you considered out of scope and what would they be?

16 Where, I don't like any of this kind of technology, 17 is that what I should conclude from that?

18 MS. MOSER: Yes, we received a few comments 19 that expressed opposition to the facility which we 20 considered out of scope for the environmental impact 21 statement.

22 Other out of scope comments included --

23 CHAIRMAN BURNS: But, why were they out of 24 scope? They can -- it's fine to be against the facility 25 but you have to have some -- I presume there has to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

190 1 some content there that is relevant to the 2 considerations we take into account?

3 MS. MOSER: Correct. If it would have 4 described environmental concerns that should have 5 been -- that were within the scope of what we analyzed 6 in the Environmental Impact Statement such as concerns 7 from potential accidents, then that we would have 8 considered within scope and that we would have analyzed 9 within the EIS.

10 CHAIRMAN BURNS: Okay.

11 You said that there were no historic or 12 archaeological or the impact on historic or 13 archaeological resources wasn't an identified.

14 You did receive one, maybe two comments 15 from Tribal organizations. What was the nature of 16 those comments?

17 MS. MOSER: Both of the Tribes that 18 submitted comments to us expressed that they wanted to 19 know additional information if any studies occurred or 20 if there was an inadvertent find of something like human 21 remains, they wanted to be notified.

22 CHAIRMAN BURNS: Okay. So, they want to 23 be informed if further studies were done or significant 24 remains of some kind?

25 MS. MOSER: Well, to clarify, one of them NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

191 1 asked for a copy of the study that was conducted onsite.

2 CHAIRMAN BURNS: Okay, okay. All right, 3 thanks.

4 I wanted -- the last question I have, I want 5 to understand in terms of the assessment of alternative 6 sites and the Chippewa Falls site and the Stevens Lake 7 or Stevens Point, thank you, Commissioner, Stevens 8 Point site.

9 You described and I saw also in the 10 Applicant's presentation that the differences in 11 impacts were moderate or described as moderate with 12 respect to the Stevens Point and Chippewa site.

13 And, I think you describe it that that 14 became moderate because of noise consideration. Is 15 that the only thing that reached your assessment that 16 it would become a moderate impact?

17 MS. MOSER: At Stevens Point, it was noise, 18 visual resources --

19 CHAIRMAN BURNS: Oh, visual, that's right.

20 MS. MOSER: -- and traffic.

21 CHAIRMAN BURNS: Okay.

22 MS. MOSER: And, at Chippewa Falls it was 23 noise and traffic.

24 CHAIRMAN BURNS: But, the traffic, it 25 sounded like the traffic at all three sites --

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

192 1 MS. MOSER: Exactly.

2 CHAIRMAN BURNS: -- is more or less the 3 same?

4 MS. MOSER: Yes, at all three sites.

5 CHAIRMAN BURNS: What tips over into a 6 moderate impact in terms of noise? Is it the population 7 near to the -- you said -- I know you described that 8 whoever has their house nearest to that site is closer 9 than at the Janesville site or the proposed site.

10 Is it also a factor of population in those 11 areas?

12 MS. MOSER: Two main factors drove that.

13 One was, as you mentioned, how close the nearest 14 resident is because that would affect how audible the 15 noise is.

16 The second factor is what's the change in 17 noise? So, the amount of noise would be similar across 18 all three sites, but because at the alternative sites, 19 the background noise is less. The delta, the change in 20 noise would be more noticeable.

21 CHAIRMAN BURNS: And, is this noise 22 primarily during the construction period or demolition 23 period or is it normal operations?

24 MS. MOSER: Primarily during construction 25 and decommissioning.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

193 1 CHAIRMAN BURNS: Okay. All right, thank 2 you very much.

3 Commissioner Svinicki?

4 COMMISSIONER SVINICKI: May I testify, Mr.

5 Chairman, that both Chippewa Falls and Stevens Point and 6 Janesville are very lovely locations. And, just as 7 someone who will be traveling to Wisconsin next week, 8 I would commend to you that the State of Wisconsin has 9 a really impressive state park and trail system.

10 And, to Commissioner Ostendorff, for those 11 of us into cycling, distance cycling, Wisconsin has some 12 of the earliest rails to trails conversions that are 13 paved and really extensive. Some of them go through old 14 railroad tunnels.

15 Now, I did note that the Applicant's photos 16 of site characterizations showed everyone bundled up 17 and shivering in the cold. The staff's visit in July, 18 those were lovely photos that tell you the beauty, the 19 natural beauty, of the State of Wisconsin and the 20 Janesville area.

21 This is the environmental panel, so this is 22 all germane to our discussion here.

23 I do thank everyone for their presentations 24 and for all of their hard work that is underlying these 25 evaluations that have been done.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

194 1 To the staff, interestingly, I came at your 2 elective choice to do an EIS from the complete opposite 3 perspective of a question that the Chairman asked you.

4 An EIS was not strictly required here and given that, 5 one can always elect to do more because there's never 6 anyone who's going to prohibit you from doing the EIS 7 versus the environmental assessment.

8 How does the staff establish a system of 9 discriminating elements that you don't always default 10 to doing something, doing the EIS, the more involved 11 process? It does increase the resource investment and, 12 you know, has the potential to increase the time 13 duration of the review process as a whole, depending on 14 how the safety review is proceeding in parallel.

15 You know, how does the -- what would be 16 backstops when the staff would say yes, an environmental 17 assessment is indeed the appropriate thing to do if you 18 have the elective choice?

19 MS. MARSHALL: One of our points of 20 consideration was how well the staff understood the 21 impacts before performing the assessment. Because 22 this was a first-of-a-kind application for this 23 technology, the staff was not certain with what the 24 outcome of the assessment would be.

25 If we had performed an environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

195 1 assessment and produced a finding, we would have had to 2 do the Environmental Impact Statement following the 3 assessment. So, that would have increased the time 4 line.

5 We also considered what actions we would 6 take which included public involvement even in an 7 environmental assessment and the time lines for either 8 an EA or an EIS came out very similar.

9 COMMISSIONER SVINICKI: That is an 10 important point and I appreciate you mentioning it that 11 an EA can lead to an EIS, so it is not necessarily an 12 either or. You may end up doing the Environmental 13 Impact Statement even if you begin with the 14 environmental assessment process.

15 So, thank you for the answer on that.

16 Again, the Applicant has discussed the fact 17 that they have a policy of transparency and outreach.

18 They touched on that in the overview and they touched 19 on it here in this panel with their testimony.

20 I would ask the Applicant, could you 21 elaborate on your separate and distinct outreach and 22 just creating awareness of the proposed facility and 23 what it would do separate from the staff's outreach 24 under -- to Tribal entities under Tribal outreach for 25 the EIS? Could you discuss any specific outreach you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

196 1 did to the Potawatomi Tribe or to the Ho-chunk Nation 2 and what form that took? Did you make overtures of your 3 own as the Applicant?

4 MS. PITAS: We did. So, we sent letters to 5 all of the 13 Tribes that I mentioned in my presentation.

6 And then, when we failed to receive responses from the 7 majority of them, actually made phone calls and, in most 8 cases, left voice mail messages with most of them.

9 COMMISSIONER SVINICKI: Okay.

10 MS. PITAS: And maybe even all of them. I 11 think probably all of them.

12 COMMISSIONER SVINICKI: Okay, thank you.

13 And, I'll just close by just saying, Jane, 14 you should go to Janesville. Did you go on the trip to 15 Janesville? If there was a Kristinesville, I would 16 definitely go.

17 MS. MARSHALL: I really wanted to go during 18 the --

19 COMMISSIONER SVINICKI: Oh, and he should 20 go to Stevens Point.

21 CHAIRMAN BURNS: They spell it 22 differently.

23 MS. MARSHALL: But no, I do hope to go in 24 the future.

25 COMMISSIONER SVINICKI: Okay. All right, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

197 1 thank you.

2 Thank you, Mr. Chairman.

3 CHAIRMAN BURNS: Thank you, Commissioner.

4 Commissioner Ostendorff?

5 COMMISSIONER OSTENDORFF: Well, since 6 we're still on the travelogue, I think Commissioner 7 Svinicki and I share a common experience every -- twice 8 a day, every day, as we drive from Northern Virginia into 9 the NRC via the American Legion Bridge listening to the 10 WTOP Traffic on the Eights or looking at the Waze display 11 on our iPhones, is it a fair statement that the traffic 12 in Janesville is less than in this area?

13 COMMISSIONER SVINICKI: It is, but I 14 appreciate that the staff has looked at not replicating 15 the Washington traffic in Janesville, which I don't 16 think any Janesvillian would appreciate.

17 COMMISSIONER OSTENDORFF: Good, thank 18 you.

19 I thought that was the case, but I 20 appreciate your clarification.

21 So, let me turn to the Applicant and I'm 22 going to ask Katrina a question on outreach as well.

23 And, it really gets into the unique nature of this 24 facility.

25 Certainly, Wisconsin's had experience with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

198 1 the Kewaunee Nuclear Power Plant and Point Beach 2 commercial power reactors. But here, we're talking 3 about, you know, deuterium bombarding tritium and 4 generating 14 MeV and, you know, neutrons and the whole 5 nuclear physics chain. And, the source term is very 6 different from commercial power reactors.

7 What can you tell us about the 8 understanding from your perspective with the SHINE 9 organization of the local community's appreciation for 10 what this is and what it's not compared to a commercial 11 power reactor? Does that make sense to you?

12 MS. PITAS: It does. And, it's a 13 difficult question to answer because I think there is 14 a wide range of understanding within the community. I 15 think the community especially appreciates the global 16 impact of the product, medical isotopes, in particular.

17 We've done our best to develop materials 18 that are simple enough that they increase the 19 understanding of someone without an expert level 20 understanding of nuclear processes and work hard to 21 bring those to our outreach meetings with the community.

22 So, we have posters, brochures.

23 In terms of understanding maybe the hazards 24 of the facility --

25 COMMISSIONER OSTENDORFF: Well, I think on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

199 1 your slides and the overview panel earlier today talks 2 about the source term being a factor of hundreds less 3 than for existing isotope production reactors 4 elsewhere.

5 So, looking at the relative scale of the 6 radiological source, do people understand that?

7 MS. PITAS: Yes, so I think so. It's one 8 of the key talking points that we use with the public 9 is in comparison to current production methods, the 10 amount of radioactivity produced per useful medical 11 isotope is hundreds of times less than -- yes, people 12 see that as a major benefit and a step forward for global 13 medical isotope production.

14 COMMISSIONER OSTENDORFF: Okay. Let me 15 stay with the Applicant for a separate question.

16 You know, our staff talked about the 17 complementary environmental impact statement work 18 between the NRC staff and the Department of Energy. As 19 far as the SHINE organization's concerned, did you see 20 a fairly consistent approach or did you see evidence 21 that different approaches between NRC type questions 22 and Department of Energy questions or how would you 23 characterize that experience?

24 MS. PITAS: I'm not sure I know. I'm not 25 very -- yes, go ahead, we'll call Greg Piefer to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

200 1 stand.

2 MR. PIEFER: So, Greg Piefer, still under 3 oath.

4 I think, you know, DOE largely let the NRC 5 process drive the show here and I think the NRC process 6 was very thorough. I assume there were some 7 negotiations behind the scenes in terms of making sure 8 DOE specific assessments were included in the NRC 9 process.

10 But, you know, I think it worked out pretty 11 well in this case and I think the NRC EIS time line was 12 within sort of the Construction Permit Safety Review 13 time line and so, it didn't add any time.

14 And, you know, the DOE EIS process who knows 15 what would have happened if they had chosen to do an EIS.

16 And so, I think, you know, ultimately, it worked out well 17 in this case.

18 COMMISSIONER OSTENDORFF: Okay, thank 19 you.

20 My final comment relates to the NRC staff 21 and goes to Michelle. Your comments and the Chairman's 22 comments on the alternative technologies, I appreciate 23 it.

24 It seems like the staff has exercised a very 25 commonsense approach. If there's not something there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

201 1 to evaluate then we shouldn't evaluate it. And so, it 2 looks like you all made a judgment call that there was 3 not sufficient evidence to look at some of these other 4 alternative technologies, so I just wanted to comment 5 favorably on the approach being taken.

6 Thank you. Thank you all.

7 CHAIRMAN BURNS: Thank you, Commissioner.

8 Commissioner Baran?

9 COMMISSIONER BARAN: Thanks.

10 Michelle, the staff's answer to 11 pre-hearing question 53 stated that it took climate 12 change into account when examining impacts to the 13 affected resources. The staff explained that it looked 14 at annual mean temperature increases and the increase 15 in the frequency, duration and intensity of droughts.

16 I really appreciate that you did that, that 17 the staff did that analysis. I think we should be 18 factoring in climate change impacts into our 19 environmental reviews more often. So, I commend you 20 all for doing that.

21 Can you tell us a little bit more about what 22 you did and how you did it?

23 MS. MOSER: Certainly. In Section 4.2 of 24 the EIS is where we analyzed emissions that could 25 potentially contribute to climate change. And, in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

202 1 Section 4.13, we conducted a cumulative impacts 2 analysis where we looked at what the overlapping impacts 3 could be from climate change on the environmental 4 resources that could also be affected by the proposed 5 SHINE facility.

6 COMMISSIONER BARAN: Thank you.

7 I also wanted to follow up on Commissioner 8 Svinicki's question about greater than Class C waste 9 that she asked earlier.

10 In response to that question, SHINE, you 11 noted that under the American Medical Isotope 12 Production Act, DOE would take title to and dispose of 13 any radioactive waste without a disposal path.

14 My question is, have you had any 15 discussions with DOE about how this program would work?

16 Are they committing to physically take possession of the 17 waste or make arrangements to store it or dispose of it 18 at another location within a certain time frame?

19 MS. PITAS: We'd like to call Vann Bynum to 20 the stand to talk about that.

21 CHAIRMAN BURNS: And, again, state your 22 name and confirm that you've been put under oath.

23 MR. BYNUM: My name's Vann Bynum and I did 24 take the oath this morning.

25 COMMISSIONER BURNS: Okay.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

203 1 MR. BYNUM: We've had a number of 2 discussions with DOE both at NNSA side and the EM side 3 for the lease and take back program. They've provided 4 us a draft contract template for the take back and we're 5 expecting a revised draft coming in January when the 6 program's supposed to be stood up. So, there's been 7 extensive discussions with them.

8 COMMISSIONER BARAN: Okay. And is this a 9 matter of them taking formal title to the waste or are 10 they physically going to take it off your hands somehow?

11 MR. BYNUM: Physically take it off our 12 hands.

13 COMMISSIONER BARAN: Okay. So, when you 14 all kind of are looking at how long you would expect to 15 potentially need to store it onsite, you're factoring 16 in that DOE is committing to actually take it offsite 17 for you?

18 MR. BYNUM: Yes.

19 COMMISSIONER BARAN: Yes? And it's a 20 relatively short time frame?

21 MR. BYNUM: We hope.

22 COMMISSIONER BARAN: You hope? Okay.

23 Fair enough.

24 That's all I have. Thank you.

25 MR. BYNUM: Thank you.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

204 1 COMMISSIONER BARAN: Thank you, Mr.

2 Chairman.

3 CHAIRMAN BURNS: Well, thanks --

4 COMMISSIONER BARAN: I should just note, I 5 don't have any tourism related questions. At some 6 point on this panel, I'm like, wow, when did I join the 7 Wisconsin Tourism Commission? But, I'll just --

8 COMMISSIONER SVINICKI: We should be so 9 lucky.

10 COMMISSIONER BARAN: I'm from the 11 Chicagoland area. Wisconsin's lovely.

12 COMMISSIONER SVINICKI: So, you're from 13 Chicagoland and you've never vacationed in Wisconsin?

14 You are the only person from Illinois that on a nice 15 weekend is not up there clogging all the highways into 16 Wisconsin.

17 COMMISSIONER BARAN: I did not say that --

18 COMMISSIONER SVINICKI: And owning all the 19 prime real estate.

20 COMMISSIONER BARAN: I don't have any 21 prime real estate in Wisconsin. I have vacationed 22 there, I just wasn't, you know, like advocating 23 vacationing there in the same way.

24 CHAIRMAN BURNS: And, I engaged in some 25 other -- I told Commissioner Svinicki, I actually NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

205 1 represented staff in proceedings in Wisconsin on the La 2 Crosse reactor which is --

3 COMMISSIONER SVINICKI: And, I do recall 4 you said it was beautiful there.

5 CHAIRMAN BURNS: And, it was beautiful, 6 it's a gorgeous area.

7 So, we'll have travel brochures as you exit 8 today.

9 But, I want to thank the environmental 10 panel.

11 We're going to take about a five, ten minute 12 break here. Try to be back in about five or six minutes.

13 And then we'll have the closing presentations from both 14 the Applicant and from the staff.

15 And, for both the Applicant and the staff, 16 I would say if there is any clarification, before your 17 closing statement, if there's any clarification you 18 want to make to the presentations, that would be the 19 time. We can make time to do what you feel you're 20 prepared to do today.

21 And, with that, we'll, again, adjourn for 22 about ten minutes.

23 (Whereupon, the above-entitled matter went 24 off the record at 3:00 p.m.)

25 CHAIRMAN BURNS: Well, good afternoon NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

206 1 again. This is the closing portion of the hearing and 2 we'll start first with the Applicant and I think, Mr.

3 Piefer, you're going to do -- is there any other 4 supplement that you all wanted to do to your testimony 5 or --

6 MR. PIEFER: No, we have no additions --

7 CHAIRMAN BURNS: Okay.

8 MR. PIEFER: -- or changes.

9 CHAIRMAN BURNS: Then please proceed.

10 MR. PIEFER: Yes. So I have very little to 11 say at this point. I just wanted to thank you guys again 12 for your time, your consideration in this very important 13 matter.

14 I did want to offer thanks and commendation 15 to the staff for very transparent and straightforward 16 communications throughout this process. I think our 17 team has been very impressed and wanted to let you guys 18 know that. So thank you again for your time today and 19 really appreciate the consideration.

20 CHAIRMAN BURNS: Thank you. Mr. Dean, 21 you're on for the staff, but there may be some supplement 22 that the staff would like to make at this point?

23 MR. DEAN: Yes, thank you, Chairman. Yes, 24 this morning we had I think a few open questions, open 25 issues where we didn't either cleanly answer the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

207 1 question or maybe we left a question open, so we thought 2 it would be beneficial if Steve Lynch could provide you 3 responses to the five particular areas where we think 4 we needed to provide more clarification. So if you 5 don't mind, I'll have 6 Steve --

7 CHAIRMAN BURNS: Okay. Mr. Lynch, please 8 proceed.

9 MR. LYNCH: Yes, I'll run through these 10 very quickly. The first was with respect to the size 11 of aircraft that were analyzed for our review. Just 12 wanted to clarify that the staff examined -- there were 13 three main categories of aircraft that were broadly 14 military, small and large. And the analysis was 15 probabilistic on this looking at both those types of 16 aircraft that would land at the airport and those that 17 would be passing overhead in the corridors. So for this 18 analysis no matter whether the aircraft was landing at 19 the SHINE site, or at the airport across the street, or 20 overhead, if the probability was less than the 21 threshold, it was excluded from examination. The only 22 types of aircraft were two small aircraft, the 23 Challenger 605 and the Hawker 400, that SHINE analyzed 24 as being above the threshold and the facility has been 25 designed to withstand those aircraft impacts.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

208 1 The second issue we had identified was the 2 natural gas pipelines. To clarify, yes, the staff did 3 look at natural gas pipelines near the SHINE facility 4 and at the SHINE facility. These are provided in 5 figures both in the staff's SER and SHINE's PSAR in 6 chapter 2. There's also a table in SHINE's PSAR in 7 chapter 2 that gives distances and sizes of the natural 8 gas pipelines surrounding the facility. While the 9 sizes of the pipelines are proprietary information, the 10 distances are given.

11 The next issue I had, I wanted to clarify 12 some statements that we made with respect to 13 differentiating between the irradiation facility and 14 the production facility. In our Interim Staff Guidance 15 we had initially assumed that the irradiation facility 16 or an irradiation-like facility would be dependent 17 functionally on the production facility in order to 18 perform and make medical radioisotopes. So that is why 19 in our guidance we'd initially thought that a single 20 production facility license could be issued for the 21 entire facility.

22 After reviewing SHINE's application we 23 came to the understanding that the irradiation facility 24 and radioisotope production facility could operate 25 separately and independently, meaning SHINE can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

209 1 irradiate as much uranium as they want at the 2 irradiation facility without impacting the function of 3 the production facility. They don't even need to be in 4 the same building. They could be in different states.

5 So because of that we understood that the irradiation 6 facility is licensed as irradiation units and the 7 production facility is separately licensed as the 8 production facility.

9 The next issue I wanted to address were 10 distinguishing between commitments and conditions.

11 Items that are identified in SHINE's Corrective Action 12 Program that they provided to the staff and that the 13 staff determined could be reasonably left for later 14 consideration in the final safety analysis report, 15 those represent the regulatory commitments that SHINE 16 has made. The conditions on the other hand are issues 17 that the staff would like more information on during 18 construction. And we'd like to emphasize that the 19 conditions, unlike the commitments, cannot be changed 20 without prior NRC approval.

21 And then the final item that I would like 22 to provide clarification on were the differences 23 between the soluble uranium intake concentrations of 10 24 milligrams per week for occupational limits and 30 25 milligrams for accident conditions. So that's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

210 1 essentially it. We think these two limits are 2 compatible and that for an occupational worker if you're 3 receiving 10 milligrams per week per the regulations you 4 could receive up to 520 milligrams of soluble uranium 5 and still be in line with the regulations each year.

6 The 30-milligram intake in contrast to that 7 is assuming an acute exposure from a highly unlikely 8 accident, meaning this is an event that has a 10 to the 9 minus 5 likelihood of occurring over a 24-hour period.

10 So we think the differences between routine 11 occupational exposure versus an acute accident exposure 12 explained the differences and that they are consistent 13 with one another.

14 And those are all the comments that I have 15 to make.

16 CHAIRMAN BURNS: Okay. Mr. Dean, proceed 17 with your --

18 MR. DEAN: Thank you. And in light of the 19 previous discussion, I have been to Williamsburg. I 20 don't know if that counts --

21 (Laughter) 22 MR. DEAN: Kristinesville and Barantown.

23 I don't know.

24 The staff's review of the SHINE 25 construction permit application supports the national NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

211 1 policy objectives of establishing a domestic supply of 2 molybdenum-99. The SHINE review presented a number of 3 unique technical and licensing considerations for the 4 staff. The timely completion of this review required 5 the expertise, cooperation and dedication of staff 6 throughout the agency. The thoroughness of the staff's 7 evaluation is reflected by the Advisory Committee on 8 Reactor Safeguards' recommendation to issue the 9 construction permit.

10 I'd particularly like to commend our staff 11 given the fact that this was a first of a kind, unique 12 review and the fact that they were able to accomplish 13 it in a short time frame, within two years. And I 14 particularly want to commend the individual on my right, 15 Mr. Lynch, who has been the project manager for the 16 SHINE. He has just done a tremendous job in terms of 17 overseeing that. So I wanted to take the opportunity 18 to do that at this time.

19 The staff evaluated SHINE's preliminary 20 design to ensure sufficiency of information to provide 21 reasonable assurance that the final design will conform 22 to the design-bases. The staff considered the 23 preliminary analysis and evaluation of the design and 24 performance of structures, systems and components of 25 the SHINE facility with the objective of assessing the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

212 1 risk to public health and safety resulting from 2 operation of the facility.

3 Structures, systems and components were 4 evaluated to ensure that they would adequately provide 5 for the prevention of accidents and the mitigation of 6 consequences of accidents. And the staff also 7 considered the potential environmental impact of the 8 facility in accordance with the National Environmental 9 Policy Act.

10 The objective of the staff's evaluation was 11 to assess the sufficiency of information contained in 12 the PSAR for the issuance of a construction permit. As 13 such, the staff's evaluation of the preliminary design 14 and analysis of the SHINE facility does not constitute 15 approval of the safety of any design features or 16 specifications. Such approval will be made following 17 the evaluation of the final design of the facility as 18 described in the FSAR as part of SHINE's operating 19 license application. An in-depth evaluation of the 20 SHINE design will be performed following the staff's 21 receipt of SHINE's FSAR.

22 Based on the findings of the staff's review 23 as documented in the Safety Evaluation Report and the 24 final EIS, Environmental Impact Statement, and in 25 accordance with 10 CFR Parts 50 and 51, the staff NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

213 1 concludes that there is sufficient information for the 2 Commission to issue the subject construction permit to 3 SHINE. And that concludes my closing remarks.

4 CHAIRMAN BURNS: Thank you. And for 5 closing, any closing questions or remarks, we'll start 6 with Commissioner Svinicki.

7 COMMISSIONER SVINICKI: Well, again I want 8 to thank everyone for their presentations. And, Bill, 9 I appreciate that you've been to Williamsburg. And all 10 I have to say, at the risk of sounding like John Belushi 11 in Animal House, if there's a Barantown, I got one thing 12 to say: Road trip. I think we should move immediately 13 that the Commission make a road trip there.

14 On a more serious note, I think we don't get 15 to this stage in the licensing process or the issuance 16 of a construction permit without tremendous dedication 17 to the task by both the Applicant and the staff, and 18 tremendous professionalism I think was displayed, not 19 only today, but was evident in the description in the 20 engagements both with external parties and with each 21 other that we've heard about in the answers to the 22 questions throughout the mandatory hearing here today.

23 Again, I'd just note for anyone listening 24 unfamiliar with this process, this hearing and the Q &

25 A we conducted is not the totality of the record. There NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

214 1 is tremendous analytical record that backs up all of the 2 responses that we heard today. It is voluminous. And 3 then there were prehearing materials and testimony that 4 was provided to all members of the Commission, which we 5 began with a presumption today that the Commission 6 already knew that, but that was hundreds of pages I think 7 in and of itself.

8 So I thank again, especially looking 9 inwardly to the NRC, all of the NRC staff that 10 contributed. And that's everyone, both the technical 11 staff, the legal staff, but all those in support roles 12 that make it possible to conduct a hearing like this.

13 And I think that the Commission is well-served to make 14 a very efficient deliberation and hopefully a timely 15 decision on this matter. Thank you, Mr. Chairman.

16 CHAIRMAN BURNS: Thank you. Commissioner 17 Ostendorff?

18 COMMISSIONER OSTENDORFF: Thank you. I 19 have no questions. My comments are very similar to 20 Commissioner Svinicki's for SHINE and the organization.

21 I appreciate the professionalism and the attention to 22 detail that you've obviously provided in your 23 application.

24 To the NRC staff, I am pleased to be part 25 of an organization looking at a new technology and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

215 1 looking at things that are different from what we've 2 done in the past. And so I think that aspect that's been 3 highlighted by many at this table today is very 4 significant. And being able to take a good look at what 5 our regulations require, what's the spirit and the 6 intent and how to apply those to areas where perhaps all 7 the Is may not be dotted and all the Ts may not be 8 crossed, but in a way to execute our responsibilities 9 in a common sense approach when there may not be complete 10 word-for-word coverage that's identical to what we've 11 dealt with in the past. So that's I think a significant 12 accomplishment.

13 And I do appreciate the work of all the 14 staff, as Commissioner Svinicki noted, across the 15 entire agency. Well done.

16 CHAIRMAN BURNS: Thank you. Commission 17 Baran?

18 COMMISSIONER BARAN: Well, just briefly I 19 want to join my colleagues in thanking the NRC staff and 20 SHINE for all of your hard work throughout the review 21 of this application. We appreciate the significant 22 amount of preparation that goes into one of these 23 mandatory hearings, so thank you for all that work.

24 I think today's hearing's been valuable.

25 It's a valuable part of the process and I thank everyone NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

216 1 for their efforts.

2 CHAIRMAN BURNS: Thank you. And I'll 3 conclude by echoing the comments of my colleagues. As 4 well I appreciate the effort, both the Applicant SHINE, 5 as well as the staff have put into it. And as 6 Commissioner Svinicki said, we're really just doing a 7 sampling here today. There's a much deeper record on 8 which the decision making will be based as we consider 9 whether or not to allow issuance of a construction 10 permit under the Atomic Energy Act for this facility.

11 But it reflects a lot of hard work and thoughtful work 12 by both the Applicant and the staff.

13 I also want to conclude by thanking behind 14 the scenes support we get as well from the Office of 15 Commission Appellate Adjudication and the Office of the 16 Secretary that assure the smooth flow of these 17 proceedings.

18 And with that, I will mention two other 19 things, and hopefully not be considered Scrooge in 20 announcing them. And that is that you may expect -- the 21 Applicant and staff may expect the Secretary to issue 22 an order with post-hearing questions by about December 23 22nd. And the deadline for the responses will likely 24 be December 30th. So you can do it before the new year.

25 And then also obviously we've had a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

217 1 transcript made of the proceedings here today and the 2 transcript will be provided by the Secretary with an 3 order requesting proposed corrections. That order 4 will probably be issued around December 21st with a 5 one-week deadline for transcript corrections on 6 December 28th.

7 Part of the reason for that is the 8 Commission I think in its -- in my experience, both as 9 general counsel and now returning to the agency in the 10 last year with my colleagues presiding over these 11 proceedings is the Commission is dedicated to making 12 decisions in a timely fashion in these proceedings.

13 And in saying that, I do expect us to issue a final 14 decision promptly with due regard to the complexity of 15 the issues before us.

16 Again, thank you, everyone. And we are 17 adjourned.

18 (Whereupon, the above-entitled matter went 19 off the record at 3:23 p.m.)

20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

218 1

2 3

4 5

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION 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 (Adopting Proposed Transcript Corrections, Admitting Post-Hearing Exhibits, and Closing the Record of the Proceeding) 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 Brian Newell ]

Office of the Secretary of the Commission Dated at Rockville, Maryland this 14th day of January, 2016

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 (Adopting Proposed Transcript Corrections, Admitting Post-Hearing Exhibits, and Closing the Record of the Proceeding)

The Commission held an evidentiary hearing at its Rockville, Maryland headquarters on December 15, 2015. The parties have provided proposed transcript corrections. The transcript corrections identified in Appendix A to this order are adopted. Appendix B to this order contains a revised hearing transcript that incorporates all of the adopted corrections.

In addition, the parties have submitted responses to post-hearing questions. As directed, these responses were filed as new exhibits, using the previously-established numbering scheme. Neither party objects to the admission of these new exhibits. Therefore, exhibits NRC-014 and SHN-030 are admitted into the evidentiary record. The Staff also has filed a revised exhibit, NRC-002-R, and represents that SHINE has no objection to its admission. This exhibit is admitted, and the previous version of the exhibit, NRC-002, is stricken from the record.

The adoption of transcript corrections and the admission into evidence of the new exhibits completes the procedural activities that remained pending at the conclusion of the mandatory hearing. The record of this proceeding is closed, effective as of the date of this order. This order is issued pursuant to my authority under 10 C.F.R. § 2.346(a) and (j).

IT IS SO ORDERED.

For the Commission NRC SEAL

/RA/ .

Annette L. Vietti-Cook Secretary of the Commission Dated at Rockville, Maryland, this 14th day of January, 2016.

APPENDIX A: Changes to the Transcript for the SHINE Medical Technologies, Inc.

Mandatory Hearing December 15, 2015 Page Line Correction 1 21 Change "JEFF BARAN" to "KRISTINE L. SVINICKI" 1 23 Change "KRISTINE L. SVINICKI" to "JEFF BARAN" 2 1 Add "AND WITNESSES" after "STAFF" 2 11 Insert STEPHEN MARSCHKE, S. Cohen & Associates before Jane Marshall 3 5 Replace HENNESY with HENNESSY 3 11 Delete Stephen Marschke, Sanford Cohen and Associates 5 16 Replace 189A with 189a 6 2 Replace 189A with 189a 7 22 Replace to this common with to the common 8 1 Replace NEPA Sections 102.2(a), (c) and (e) with NEPA Sections 102(2)(A), (C) and (E) 8 6 Add semicolon after "taken" 8 12 Add semicolon after "values" 9 1 Replace of witness with of witnesses 9 9 Replace the witness with the witnesses 9 10 Replace their name with their names 9 14 Replace Hennesy with Hennessy 9 13, 14 Replace Richard Van Bynum with Richard Vann Bynum 13 23 Replace HENNESY: with HENNESSY:

13 23 Replace Hennesy with Hennessy 18 2 Replace insure with ensure 19 2 Replace insure with ensure 19 17 Replace insure with ensure 19 18 Replace insure with ensure 20 14 Replace insure with ensure 20 25 Replace radiation with irradiation 23 3 Replace all together with altogether 25 11 Replace plan with plans 25 23 Replace licensed with license 26 24 Replace tank is which is with tank which is 27 3 Replace radiation with irradiation 27 8 Replace for the proper with to the proper 29 2 Replace than pass with then pass 32 18 Replace is discrete with in discrete 33 15 Replace of accelerator with of the accelerator 34 21, 22 Replace ATSV off gas system with eight TSV off gas systems, 36 16 Replace insure with ensure 39 3 Replace insure with ensure 40 17 Add comma after "phase" and add a question mark after "license" 40 23 Replace HENNESY: with HENNESSY:

40 24 Replace Hennesy with Hennessy 41 16 Replace HENNESY: with HENNESSY:

42 17 Change "presentation" to "panel" 43 24 Change "work" to "wrap"

Page Line Correction 44 14 Change "area" to "areas" 46 6 Change the period to a question mark after "financial" 47 23 Replace HENNESY: with HENNESSY:

48 5 Replace HENNESY: with HENNESSY:

48 25 Delete "for" 49 4 Replace "some" with "a" 49 7 Replace HENNESY: with HENNESSY:

50 3 Replace HENNESY: with HENNESSY:

50 12 Replace HENNESY: with HENNESSY:

50 8, 9 Replace "th is" with "this" 51 12 Replace ours with ours 52 5 Replace "your's" with "yours" 52 16 Replace insure with ensure 54 14 Change "explore" to "explored" 54 17 Change "insure" to "ensure" 55 5 Change "use" to "used" 55 8 Replace HENNESY: with HENNESSY:

55 18 Replace HENNESY: with HENNESSY:

57 11 Change Go to to Could I have 57 16 Change "technetium-99m stable" to "technetium-99 metastable" 60 1 Change "NMSA" to "NNSA" 60 23 Change "5034" to "50.34" 61 6 Change "or FSAR" to ", or FSAR,"

62 4 Change "insure" to "ensure" 64 5 Change walls to wall 64 8 Change "think" to "thin" 66 9 Change "review inform" to "review, inform" 67 17 Change "areas except" to "areas, except" 67 18 Change "traffic" to "traffic,"

68 14 Change "320" to "20" 70 12 Change SHINE stated to SHINE has stated 70 20 Change "criterion" to "criteria in" 73 17 Delete the comma after "support" and change "organization" to "organizations" 73 21 Delete "it's" 78 14 Delete "you think" 78 16 Change "has" to "have" 80 10 Change ours to ours 82 22 Insert em dash between "guidance" and "in" 82 23 Replace comma and space with em dash 83 3 Set off "I'll say" with commas 84 6 Delete the first "the" 86 15 Delete "is - -"

86 22 Change "action" to "actions" 87 20 Change "insure" to "ensure" 89 3 Change "concept" to "concepts"

Page Line Correction 90 10 Change "insure" to "ensure" 91 18 Change facilities to facility 92 14 Change "MR. LYNCH" to "MR. DEAN" 96 25 Add "that" after "Guidance" and add a comma after "used" 100 17 Change in your to many of the 100 18 Change ask the questions we practice to asked are questions we practiced 101 1 Change need to to need. To 101 3 Change permit. That to permit, that 101 12 Change MS. YOUNG to COMMISSIONER SVINICKI 102 8 Replace Hennesy with Hennessy 104 5 Replace in a radiation with and irradiation 104 6 Replace maintain at shutdown with maintain it shutdown 105 12 Replace commensurate what with commensurate with 105 15, 16 Replace single family criterion with single failure criterion 106 21 Delete "will discuss" 109 19 Change "nature" to "nature,"

109 21 Change "Part 70" to "Part 70,"

111 1 Change "Because of the" to "Because of their" 111 3 Change "reactors" to "reactors,"

112 16 Change "b" to "be" 112 19 Change application to application, 114 8 Replace "to" with "of" 115 5 Replace MR. VAN ABEL: with MR. HENNESSY:

115 8 Replace MR. VAN ABEL: with MR. HENNESSY:

116 19 Change "the" to "that" 116 25 Change "of" to "on" 117 3 Change "that we" to "would be" 117 15 Change "committing to" to "committing to to" 119 18 Change Thanks you. to Thank you.

119 3, 4 Change "And the" to "But in the" 120 14 Replace HENNESY: with HENNESSY:

120 23 Replace HENNESY: with HENNESSY:

121 3 Replace HENNESY: with HENNESSY:

121 5 Replace HENNESY: with HENNESSY:

122 2 Change COMMISSIONER BARAN to CHAIRMAN BURNS 122 5 Change that replaced to that were placed 122 23 Add "a" between "of" and "temporal" 125 18 Change traverse to transverse 126 2 Change "large" to "larger" 127 7 Change COMMISSIONER BARAN to CHAIRMAN BURNS 128 13 Add "a" after "got" 128 16 Replace HENNESY: with HENNESSY:

128 19 Replace HENNESY: with HENNESSY:

128 22 Replace HENNESY: with HENNESSY:

129 2 Replace HENNESY: with HENNESSY:

Page Line Correction 129 6 Replace HENNESY: with HENNESSY:

129 20 Replace I put with I was put 130 2 Replace will able with will be able 131 19 Replace sites with site 131 23 Replace sites with site 132 1 Replace sites with site 132 2 Replace and the with in the 132 3 Replace events with event 132 10 Change "analysis" to "analyses" 132 16 Change HULL to VAN ABEL 133 9 Change be either to be for either 133 13 Delete "are of course" 134 10 Delete "of" 136 9 Change "being" to "begin" 136 13 Replace HENNESY: with HENNESSY:

136 13 Replace Hennesy with Hennessy 136 20 Replace MR. COSTEDIO: with MR. VAN ABEL:

137 20 Replace preformed with performed 137 7, 8 Replace nuclear plant operations and engineering personal experience in reactor and nuclear process safety. with nuclear plant operations and engineering, personnel experienced in reactor and nuclear process safety.

138 8 Replace a radiation with irradiation 138 11 Replace in the pool with of the pool 138 11 Replace disburses with disperses 138 16 Replace filter with filtered 138 19 Replace work with worker 138 23 Replace designated with designate it 139 3 Replace store with stored 140 4 Replace duct. with stack.

140 17 Change as the to ask the 140 24 Change "Kevin Morrissey" to "Kevin Morrissey, Fuel Cycle Safety Review."

140 25 Change "Dave Lynch" to "Steve Lynch, Project Manager, Research and Test Reactors Licensing" 141 7 Change "Projection" to "Production" 142 19 Change facilities. The to facilities, the 143 1 Change radiation facility to irradiation facility 144 23, 24 Change "where gas is produced in the irradiation process or stored" to "where gases produced in the irradiation process are stored" 145 12 Change "RM." to "MR."

148 1 Add "to" after "witnesses" 151 14 Change engineering and safety to engineering safety 151 18 Change offsite conditions. to upset conditions.

152 6 Change Chris, to Chris Tripp, 152 17 Change "vessel" to "special"

Page Line Correction 153 4 Change KANATAS" to "KOLB" 153 11 Replace 176 with 1.76 153 17 Add question mark after "that" and capitalize "the" in "The one other thing" 153 17 Insert MR. LYNCH: before "The one other thing" 153 19 Change "rain, snow" to "rain-snow" 153 20 Change event? to event.

153 21 Change "MR. LYNCH" to "CHAIRMAN BURNS" 153 23 Change "CHAIRMAN BURNS" to "MR. LYNCH" 153 24 Change "MR. LYNCH" to "CHAIRMAN BURNS" 153 25 Change "CHAIRMAN BURNS" to "MR. LYNCH" 154 1 Change "MR. LYNCH" to "CHAIRMAN BURNS" 154 2 Delete "CHAIRMAN BURNS:"

154 9 Replace MR. VAN ABLE: with MR. VAN ABEL:

156 1 Change 15.20 to 1520 157 18 Add "you" after "Thank" 158 10 Change "MS. KANATAS" to "MS. KOLB" 158 17 Change "MS. KANATAS" to "MS. KOLB" 158 20 Change "MS. KANATAS" to "MS. KOLB" 159 1 Replace license with licensed 159 5 Replace a waste control specialist with at Waste Control Specialists 159 11 Change "KANATAS" to KOLB" 159 16 Change KANATAS to KOLB 159 19 Delete "broadly" 160 11 Replace thats on the license and operators. with thats how they license their operators.

160 25 Replace HENNESY: with HENNESSY:

161 18 Delete "in" and the second "the" 161 19 Delete "is" and replace with "that we've" 161 19 Replace the comma with a period and capitalize "is" 161 22 Replace "of" with "or" 161 24 Replace No, you know, have various with No - we have various 162 20 Delete "just for" 162 23 Replace "are" with "seem" 162 24 Delete "And," and capitalize "are" 162 3, 4 Replace monitor the activity in the neutron population in the TSV radiation. with monitor the reactivity and the neutron population in the TSV during irradiation.

163 4 Replace manual with manually 163 11 Replace there would with they would 163 18 Replace not only with nominally 163 19 Replace two dampers, but every place with two dampers at every place 163 8, 9 Replace many traces available with many choices available 164 19 Replace HENNESY: with HENNESSY:

164 19 Replace Hennesy with Hennessy

Page Line Correction 164 19, 20 Replace Manager of Engineer with Manager of Engineering 165 20, 21 Replace of the affect in the environment with of the affected environment 169 8 Replace alterative with alternative 171 25 Replace Sections 102.2(a), (c) with Sections 102(2)(A), (C) 171 5, 6 Replace both to Stevens Point and the Chippewa Falls with both to Stevens Point and to Chippewa Falls 172 1 Replace and (e) with and (E) 174 14 Change and to an 174 22 Change actions to action's 176 7 Change of the an EIS to of an EIS 177 12 Change "NEC" to "NRC" 178 23 Change "visited site" to "visited the site" 183 19 Change publically to publicly 185 13 Change "residents" to "resident" 186 20 Change medial to medical 187 12 Change "adjust" to "address" 189 21 Change "provides" to revised 191 4 Change "15" to "51" 192 24 Add a comma after "source" and change "an aging" to "are" 193 18, 19 Add a comma after "Where" and add quotation marks before "I" and after "technology" 194 17 Change "were" to "was" 198 3 Delete "I actually came at --"

199 12 Change "and" to "an" 200 6 Replace Trial entities with Tribal entities 200 23 Replace "Christinesville" with "Kristinesville" 201 17 Replace "NCR" with "NRC" 201 19 Replace "ways" with "Waze" 202 5 Insert "a" after "Katrina" 202 8 Insert "with" between "experience" and "the" 202 9 Delete comma, change "with" to "and," delete "regular" 202 10 Begin "Commercial Power Reactors" with lower case letters 202 13 Replace "doing" with "the" 203 15 Delete "just, you know,"

203 10, 11 Delete "just like, you know,"

204 1 Change several questions. to a separate question.

204 24 Replace didnt new time. with didnt add any time.

205 5 Replace "comments" with "comment" 205 5 Insert "the" before "NRC" 207 6 Replace Van Bynum with Vann Bynum 207 10 Replace Van Bynum with Vann Bynum 208 21 Change "You" to "We" 209 18 Change "I" to "it" 209 20 Delete "any that,"

210 8 Add "make" after "can" and change "it that" to "what"

Page Line Correction 218 3 Change "bear in town" to "Barantown" 218 5 Delete period after "immediately" 218 5 Add "that" after "immediately" and change capital "T" to lowercase 218 19 Change A conducted to A we conducted 218 24 Replace resumption with presumption 219 19 Delete "working at" 220 2 Insert "not" between "may" and "be" 221 9 Change the Commission to the Office of Commission 221 24 Add "be" after "probably" and change "issue" to "issued"

APPENDIX B: Corrected Transcript December 15, 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 1-220 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 KRISTINE L. SVINICKI 22 WILLIAM C. OSTENDORFF 23 JEFF BARAN 24 ALSO PRESENT:

25 ANNETTE L. VIETTI-COOK, SECY NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

2 1 NRC STAFF AND WITNESSES 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 STEPHEN MARSCHKE, S. Cohen & Associates 12 JANE MARSHALL, NRR 13 KEVIN MORRISSEY, NMSS 14 MICHELLE MOSER, NRR 15 JOSEPH STAUDENMEIER, RES 16 CHRISTOPHER TRIPP, NMSS 17 CARL WEBER, NRO 18 DAVID WRONA, NRR 19 MITZI YOUNG, OGC 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

3 1

2 APPLICANT AND WITNESSES PRESENT:

3 STEPHEN BURDICK, Morgan Lewis & Bockius 4 RICHARD VANN BYNUM, SHINE Medical Technologies 5 JIM COSTEDIO, SHINE Medical Technologies 6 BILL HENNESSY, SHINE Medical Technologies 7 CHRISTOPHER HEYSEL, Information Systems 8 Laboratories 9 ALAN HULL, Golder Associates, Inc.

10 CATHERINE KOLB, SHINE Medical Technologies 11 TIMOTHY KRAUSE, Sargent & Lundy 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 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

4 1 A G E N D A 2 Overview (SHINE Medical Technologies, 3 Inc.)..........................................13 4 Commission Q & A..................................36 5 Overview (NRC Staff)..............................55 6 Commission Q & A..................................71 7 Break............................................100 8 Safety - Panel 1.................................100 9 Commission Q & A.................................112 10 Break............................................133 11 Safety - Panel 2.................................134 12 Commission Q & A.................................146 13 Environmental - Panel............................162 14 Commission Q & A.................................189 15 Break........................................... 208 16 Closing Statement by Applicant...................208 17 Closing Statement by Staff.......................212 18 Commission Q & A and Closing Statements..........215 19 20 21 22 23 24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

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 things 6 before we begin this hearing.

7 I want to welcome the audience and those who 8 may be viewing this remotely on line. Welcome to the 9 Applicant, to the Staff, members of the public. And the 10 Commission is here today to conduct an Evidentiary 11 Hearing on the SHINE Medical Technologies application 12 for a construction permit for a medical radioisotope 13 production facility in Janesville, Wisconsin.

14 This hearing is required under Section 189a 15 of the Atomic Energy Act of 1954, as amended. And the 16 Commission will also be reviewing the adequacy of the 17 NRC Staff's Environmental Impact Analysis under the 18 National Environmental Policy Act of 1969, which many 19 of us refer to as NEPA.

20 This is the third so called mandatory or 21 uncontested hearing that the Commission has held this 22 year, but unlike the two previous ones, this one is for 23 a construction permit, not for a Combined License. But 24 the requirements for the necessity of a hearing on a 25 construction permit is required as I noted under Section NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

6 1 189a.

2 During the hearing, SHINE and the Staff 3 will provide testimony and witness panels that will 4 provide an overview of the application, as well as 5 address safety and environmental issues associated with 6 the review, and Commission questions will follow each 7 panel. And there will be a rotation of the Commissioners 8 from panel to panel, and the Commissioners may allocate 9 their total time among the panels as each Commissioner 10 sees fit.

11 In order to issue a construction permit the 12 Commission must make certain specific safety and 13 environmental findings. On the safety side, the 14 Commission will determine whether in accordance with 10 15 CFR 50.35(a), whether the Applicant has described the 16 proposed design of the facility, including the 17 principal architectural and engineering criteria for 18 the design, and whether the Applicant has identified the 19 major features or components incorporated therein for 20 the protection of the health and safety of the public.

21 Also, such further technical or design information as 22 may be required to complete the safety analysis, and 23 those which can be reasonably left for later 24 consideration to be supplied in the Final Safety 25 Analysis Report; whether safety features or components, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

7 1 if any, that require research and development have been 2 described by the Applicant, and the Applicant has 3 identified, and there will be conducted a research and 4 development program reasonably designed to resolve any 5 safety questions associated with such features or 6 components; and whether on the basis of the foregoing 7 there is reasonable assurance that, one, such safety 8 questions will be satisfactorily resolved at or before 9 the latest date stated in the application for completion 10 of the construction of the proposed facility; and, two, 11 taking into consideration the site criteria contained 12 in 10 CFR Part 100, the proposed facility can be 13 constructed and operated at the proposed location 14 without undue risk to the health and safety of the 15 public.

16 In making these findings, the Commission 17 will also be guided by the considerations in 10 CFR 18 Section 50.40 which include the Commission's opinion as 19 to whether the issuance of the construction permit will 20 not be inimical to the common defense and security or 21 to the health and safety of the public.

22 With respect to environmental matters, the 23 Commission will determine whether the requirements of 24 NEPA Sections 102(2)(A), (C) and (E), and the applicable 25 regulations in 10 CFR Part 51 have been met. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

8 1 Commission will independently consider the final 2 balance among conflicting factors contained in the 3 record of the proceeding with a view to determining the 4 appropriate action to be taken; determine after 5 weighing the environmental, economic, technical, and 6 other benefits against environmental and other costs, 7 and considering reasonable alternatives whether the 8 construction permit should be issued, denied, or 9 appropriately conditioned to protect environmental 10 values; and determine whether the NEPA review conducted 11 by the Staff has been adequate.

12 This meeting is open to the public, and we 13 do not anticipate the need to close the meeting to 14 discuss non-public information, but if a party believes 15 that a response to a question may require a reference 16 to non-public information, then I would ask the party 17 to answer the question to the best of its ability and 18 practicality with information that is on the public 19 record, and file any non-public response promptly after 20 the hearing on the non-public docket.

21 Before proceeding, do my fellow 22 Commissioners have anything they'd like to add? Then 23 we'll proceed with the swearing in of witnesses. We'll 24 start first with SHINE. I'd ask counsel for SHINE to 25 introduce himself.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

9 1 MR. BURDICK: Good morning. This is Stephen 2 Burdick from Morgan Lewis & Bockius, also joined by my 3 colleague, Paul Bessette. We are counsel for SHINE.

4 CHAIRMAN BURNS: Okay. Counsel, would you 5 read the names of the witnesses?

6 MR. BURDICK: Yes, and if the witnesses 7 would please stand when I read their names, and then 8 remain standing until the Chairman directs otherwise.

9 In alphabetical order SHINE's witnesses 10 are Joseph M. Aldieri, Jeffrey M. Bartelme, Richard Vann 11 Bynum, James Costedio, William Hennessy, Alan Hull, 12 Catherine Kolb, Timothy P. Krause, Thomas Krzewinski, 13 C. Michael Launi, James W. McIntyre, John B. McLean, 14 William D. Newmyer, Greg Piefer, Katrina M. Pitas, Erwin 15 T. Prater, Louis Restrepo, Eric N. Van Abel, George F.

16 Vandegrift, Tamela B. Wheeler, Ernest Wright, and 17 Steven L. Zander. Thank you.

18 CHAIRMAN BURNS: Okay, thank you.

19 Witnesses, I'd ask you to raise your right 20 hand to take the oath.

21 Do you swear or affirm that the testimony 22 you will provide in this proceeding is the truth, the 23 whole truth, and nothing but the truth?

24 ALL WITNESSES: I do.

25 CHAIRMAN BURNS: Did anyone fail to take the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

10 1 oath? Indicate so, otherwise. No. Thank you. You may be 2 seated.

3 Is there any objection to including the 4 witness list into the record?

5 MS. KANATAS: No objections.

6 CHAIRMAN BURNS: Okay, thank you, counsel.

7 And then with respect to -- we'll proceed 8 in terms of the admission of evidence on behalf of the 9 Applicant. Are there any edits to your exhibit list, 10 counsel?

11 MR. BURDICK: There are no edits.

12 CHAIRMAN BURNS: Okay. Would you read the 13 range of numbers of the exhibits to be admitted?

14 MR. BURDICK: Yes. SHINE has submitted 15 Exhibits SHN-001 through SHN-029.

16 CHAIRMAN BURNS: Okay. And I presume you 17 propose to move those into the record?

18 MR. BURDICK: We move to admit those into the 19 record.

20 CHAIRMAN BURNS: Okay. Is there any 21 objection?

22 MS. KANATAS: No objections.

23 CHAIRMAN BURNS: Okay, very good. So, the 24 list of exhibits is admitted for the Applicant, SHINE.

25 Okay. Turning to the Staff, counsel, would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

11 1 you introduce yourself, please.

2 MS. KANATAS: My name is Catherine Kanatas, 3 and along with my counsel, Mitzi Young, we represent the 4 Staff.

5 CHAIRMAN BURNS: Okay, great. Would you read 6 the names of the proposed Staff witnesses?

7 MS. KANATAS: Yes, and if they can --

8 CHAIRMAN BURNS: And I'll ask them to stand.

9 Thank you.

10 MS. KANATAS: Thank you. Alexander Adams, 11 John Adams, Mary Adams, Stephen Alexander, David Back, 12 Marissa Bailey, Daniel Barrs, Thomas Boyle, Gregory 13 Chapman, William Dean, James Downs, Thomas Essig, Kevin 14 Folk, Mirela Gavrilas, Mary Gitnick, James Hammelman, 15 Shawn Harwell, Christopher Heysel, Gregory Hofer, 16 Robert Hoffman, Anthony Huffert, Steven Lynch, Stephen 17 Marschke, Jane Marshall, Nancy Martinez, James 18 McIlvaine, Diane Mlynarczyk, Kevin Morrisey, Michelle 19 Moser, Thomas Pham, Paul Prescott, William Rautzen, 20 Jeffrey Rikhoff, Michael Salay, Alexander Sapountzis, 21 Raymond Skarda, Soly Soto-Lugo, Joseph Staudenmeier, 22 Christopher Tripp, Glenn Tuttle, Carl Weber, Abraham 23 Weitzberg, and David Wrona.

24 CHAIRMAN BURNS: Okay, thank you.

25 So, for the Staff witnesses, I'll ask you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

12 1 to raise your right hand.

2 Do you swear or affirm that the testimony 3 you will provide in this proceeding is the truth, the 4 whole truth, and nothing but the truth?

5 ALL WITNESSES: I do.

6 CHAIRMAN BURNS: Did any -- please inform me 7 if any of you decline to take the oath. Okay, you may 8 be seated.

9 Is there any objection to including the 10 witness list?

11 MR. BURDICK: No objection.

12 CHAIRMAN BURNS: Okay. So, proceed to the 13 admission of the evidence on behalf of the NRC Staff.

14 Are there any edits, counsel, to your exhibit list?

15 MS. KANATAS: There are no edits.

16 CHAIRMAN BURNS: Would you read the range of 17 numbers on the list of exhibits to be admitted?

18 MS. KANATAS: Staff exhibits run from 19 NRC-001 through NRC-013.

20 CHAIRMAN BURNS: Okay. And I presume you 21 would move to admit those exhibits into evidence.

22 MS. KANATAS: We would like to move to admit 23 them into the record.

24 CHAIRMAN BURNS: Are there any objections?

25 MR. BURDICK: No objection.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

13 1 CHAIRMAN BURNS: Okay. And seeing no 2 objection, the exhibits are admitted. So, thank you for 3 those -- we got through the preliminaries.

4 I think at this point we're ready to have 5 the Overview Panel for SHINE. And for this portion of 6 the proceeding we'll have the Overview Panel from SHINE, 7 and I believe then we have the questions on the Overview 8 Panel, and then we'll have the Staff Panel. So, thank 9 you, counsel.

10 And, again, this is an Overview Panel for 11 opportunity for the Applicant to provide us overview of 12 the application and the proposed project. I would remind 13 the witnesses that you remain under oath. You may assume 14 that the Commission is familiar with the pre-hearing 15 filings on behalf of the Applicant, as well of the Staff.

16 And I would then ask the panelists to introduce 17 themselves. I'll start here.

18 MR. PIEFER: Yes, sir. My name is Greg 19 Piefer. I'm the founder and CEO of SHINE Medical.

20 MR. HENNESSY: My name is Bill Hennessy. I'm 21 the Manager of Engineering for SHINE.

22 MR. COSTEDIO: My name is Jim Costedio. I'm 23 the Licensing Manager for SHINE.

24 MR. VAN ABEL: My name is Eric Van Abel. I'm 25 the Engineering Supervisor for SHINE.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

14 1 CHAIRMAN BURNS: Okay. Thank you, 2 gentlemen. And you may proceed with your presentation.

3 MR. PIEFER: So, once again, my name is Greg 4 Piefer, and I want to thank the Commission, 5 Commissioners, Mr. Chairman for your consideration of 6 this very important matter. To start it off, I'd like 7 to give you guys a little bit of background on SHINE and 8 our mission as a company.

9 SHINE Medical Technologies is dedicated to 10 being the world leader in the clean, affordable 11 production of medical tracers and cancer treatment 12 elements commonly known as medical isotopes by the 13 medical community.

14 We recognize fully that in order to run this 15 business successfully our highest priority needs to be 16 on safety and reliability of the processes used to 17 produce these isotopes. At the end of the day, these 18 products will serve the needs of approximately 100,000 19 patients per day around the globe making this a very, 20 very significant endeavor in terms of health care of 21 patients. Of course, we can't operate the plant at all 22 if we're not focused on safety in our house, and so those 23 are the highest sort of values within the company.

24 Also interesting is that we come with this 25 technology to the market at a very interesting time when NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

15 1 there is a tremendous amount of transition happening in 2 the existing supply chain for these medical isotopes.

3 Currently, the only producer in the Western Hemisphere 4 of any significant volume will be leaving the market 5 permanently in 2018, and the products have a 66-hour 6 half-life, the most commonly used product has a 66-hour 7 half-life, and that creates substantial challenges for 8 U.S. patients here if we need to bring all of our medical 9 isotopes from overseas. Next slide, please.

10 Just a little bit more background on the 11 primary medical isotope that the world uses.

12 Molybdenum-99 decays into a daughter, technetium-99m, 13 and is used in about 85 percent of the nuclear medicine 14 scans performed globally.

15 Technetium-99m is extremely versatile. Its 16 chemistry allows it to attach itself to a wide variety 17 of drugs where it acts as a tracer, and essentially 18 allows doctors to see what that drug is doing. It has 19 a 6-hour half-life and so it is very difficult to 20 distribute as technetium, but because it's a daughter 21 of molybdenum-99 which has a 66-hour half-life, you can 22 distribute it around the globe fairly easily.

23 Collectively, these procedures make up 24 about 40 million doses on an annual basis, so very, very 25 high volume, and very important to patients all around NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

16 1 the world, the U.S. being approximately half of those 2 doses.

3 The pie chart included on Slide 3 shows a 4 breakdown of the procedures primarily that use 5 technetium-99m. I'm just going to call your attention 6 to two of the slices. The largest slice is labeled 7 myocardial profusion. Myocardial profusion is just a 8 way of saying looking at blood flow through the heart 9 muscle and, in fact, is commonly known as a stress test.

10 If a doctor wants to know where to put a stent, if a 11 patient is having chest pain they'll do this. If they 12 want to see if the heart has been damaged by a heart 13 attack, they'll do this test, so very, very useful when 14 you look at the number one killer of human beings in the 15 United States, cardiac disease. And the number two use 16 is for something called a bone scan which is used to 17 stage cancer. And that is the number two killer of people 18 in this country. So, very important products, very 19 widely used today, and it's very important that the 20 supply chain remain robust for many, many years to come.

21 Next slide, please.

22 However, it is not clear that the supply 23 chain will remain resilient on the current track without 24 new production. In fact, it looks like it will not be 25 able to meet the needs, the growing needs of the globe NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

17 1 in terms of medical isotope production.

2 I mention the Canadian reactor is exiting 3 the market permanently in March of 2018, and they 4 actually plan to decommission that reactor, at which 5 time the Western Hemisphere will not have a source 6 barring new entrants coming in. And this is not going 7 to create just a problem over here, but it's going to 8 create a global problem. In fact, the Nuclear Energy 9 Agency as part of the Organization of Economic 10 Cooperation and Development has been performing studies 11 on exactly this situation for the last several years, 12 and we've included a small bit of data from the most 13 recent study which shows current demand growth in the 14 green line, and current production capacity in the 15 orangish line. As you see, it kind of dips down when 16 Canada leaves.

17 I'll note that this demand graph does 18 include something called outage reserve capacity and 19 so, you know, there's a little buffer on what's actually 20 required, but that's important. That's what the market 21 needs in order to operate reliably and ensure that 22 patients can get the products they need and manage the 23 occasional outage because the supply chain is on the 24 order of 50 to 60 years old in most cases, the research 25 reactors producing this isotope.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

18 1 So it's a very, very, I think, stressful 2 situation for the medical community right now not 3 knowing where their answers are going to lie in the long 4 term, and that problem creates an opportunity for new 5 technology to come in and sort of change the way we've 6 been making medical isotopes in this country, and really 7 do it in a better way. And that's what we believe we've 8 done here. You're going to hear a lot more about how we 9 plan to do that as the day goes on.

10 But when we developed this technology, 11 we've been working on it since about 2006, we had some 12 core values as a company when we founded the company that 13 really are embodied by the technological approach 14 you're going to hear about. And, obviously, as I 15 mentioned in the beginning, we believe at the very 16 highest level that it is impossible to run this company 17 without protecting the health and safety of our workers, 18 the public, and the environment, so these have been 19 factors in our consideration from day one when we were 20 looking at what technologies to choose and what approach 21 to go forward on.

22 On top of that, we need to ensure based on 23 the short half-life of these products that we can get 24 the product out regularly, on time every time. Again, 25 with 66 hours2.75 days <br />0.393 weeks <br />0.0904 months <br />, you know, there's really no forgiveness NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

19 1 for substantial delays. It just means that patients 2 aren't going to get the products they need if you can't 3 deliver. And that's unfortunate if a patient presents 4 with chest pains and a doctor is concerned they may have 5 had a heart attack and has to tell them to come back, 6 you know, maybe in a week and hope you make it, or has 7 to give them an alternative isotope that will leave them 8 radioactive for weeks. Stay away from small children for 9 quite some time. It's just not good for the patients, 10 so we need to get this out every single time.

11 We also needed to ensure 12 cost-effectiveness. We had to ensure an approach that 13 would allow us to make medical isotopes that can be 14 bought. You know, it's a time when reimbursement is 15 generally across the board decreasing in the United 16 States, and it's important that a cost-effective 17 technology be developed so that this doesn't become 18 prohibitive in terms of cost for patient access.

19 And, finally, something that's been very 20 strong in our minds since the beginning is that it's not 21 necessary to use highly enriched uranium to make medical 22 isotopes; however, it is commonly used around the globe 23 today. So, we designed our process to eliminate the need 24 for highly enriched uranium and, in fact, use only low 25 enriched uranium as part of our process.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

20 1 The risk posed to the U.S. public by the 2 proliferation of highly enriched uranium is extremely 3 high. If there were to be an event, the consequences 4 would be disastrous, and we fully support the U.S.

5 Government's initiatives to remove highly enriched 6 uranium from the supply chain and, in fact, stop 7 shipping it around the world to ensure that we have 8 appropriate medical tracers.

9 So, these are all things that drove our 10 mission and drove our values, or drove our technology 11 rather. So, I'm going to just give you a high level view 12 of the technology and how it reflects those values.

13 Fundamentally, the biggest protection that 14 we have is that these systems have been designed to be 15 small, and I'm talking about small in terms of thermal 16 power equivalent. When you look at a SHINE production 17 unit or irradiation unit, you'll hear more about this 18 throughout the day, the thermal power of one of these 19 systems is on the order of 100 kilowatts when its 20 producing at full tilt. If you were to compare this to 21 a reactor like the NRU which is also producing medical 22 isotopes today, that reactor's thermal power equivalent 23 is 135 megawatts, so there's about a factor of 1,000 24 difference in thermal power from a SHINE-based system 25 to a reactor-based system. And that has tremendous NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

21 1 safety benefits for us, including low source term and 2 very low decay heat. If we shut one of our systems within 3 hours0.125 days <br />0.0179 weeks <br />0.00411 months <br />, just a few hours we're down to about a kilowatt 4 of decay heat, so we're talking about something that's 5 less than a hair dryer. So you don't have a lot of the 6 concerns you would have with loss of power in much larger 7 facilities.

8 In addition to the safety benefits just 9 from the lower source term and lower decay heat, of 10 course, we're producing less radionuclides overall that 11 a much larger reactor would do, and that allows us to 12 use commercial disposal for much, if not all, of our 13 disposal path. It's a great economic benefit and 14 certainty benefit in terms of final disposition of waste 15 products.

16 Secondly, we developed a low enriched 17 uranium target that is not only novel in terms of being 18 aqueous, the target is in a liquid form, but it's also 19 the first target that I'm aware of that is reusable. And 20 the reusability of our target actually gives us a 21 substantial economic advantage.

22 Currently in the supply chain, metal 23 targets are used, solid targets are placed next to a 24 reactor core. They're irradiated. Much of the uranium 25 does not fission, they're dissolved and the medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

22 1 isotopes are extracted out, and the rest of the uranium 2 is essentially thrown away. Well, in fact, since it's 3 highly enriched uranium in most of these cases, it's 4 thrown into tanks and very carefully monitored. But the 5 reusable target for us is a major, major improvement.

6 And, finally, the system is driven by a low 7 energy electrostatic accelerator. I say low energy, 8 that's about 300 kilovolts, 300 kilo electron volts beam 9 energy. And if you were to compare that to a cyclotron 10 that would be found in a pharmacy today that makes 11 isotopes such as fluorine-18, those are on the order of 12 10 MeV, Mega Electron Volts, so it's much lower, much 13 simpler accelerator that we're using to drive this 14 target. And that also allows us to operate below 15 criticality.

16 Some liquid reactors have been operated in 17 the past and they operate at criticality with control 18 rods. We've chosen for a number of reasons to eliminate 19 criticality altogether and use this accelerator system 20 to drive the liquid target. And that gives us, again, 21 substantially less waste by eliminating the need for a 22 reactor as the primary neutron source. It is also 23 proven, demonstrated, and fairly cost-effective 24 technology that actually people can come and see if 25 they'd like. It's in our lab.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

23 1 So, I guess that concludes my presentation.

2 I'm going to turn the rest of the overview over to Jim 3 Costedio.

4 MR. COSTEDIO: Good morning. Next slide, 5 please.

6 The SHINE facility is located on a 7 previously undeveloped 91-acre parcel in the southern 8 boundaries of the City of Janesville in Rock County, 9 Wisconsin. If you look at the map, the area outlined in 10 red on the southern boundary is Rock County. Next slide, 11 please.

12 The SHINE facility layout consists of an 13 irradiation facility or the IF, and a radioisotope 14 production facility, or the RPF. The area outlined in 15 blue is the irradiation facility which houses the 16 irradiation units, and the area outlined in red is the 17 radioisotope production facility which houses the hot 18 cells. The facility is relatively small compared to the 19 size of the parcel. It's a 91-acre parcel, and the 20 facility is about 55,000 square feet centered 21 approximately in the middle of the parcel. Next slide, 22 please.

23 The SHINE IF consists of eight subcritical 24 irradiation units which are comparable in thermal power 25 level and safety considerations to existing non-power NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

24 1 reactors licensed under 10 CFR Part 50. However, due to 2 the subcriticality, the irradiation units did not meet 3 the existing definition of utilization facility in 10 4 CFR 50.2. To align the licensing process with the 5 potential hazards, the NRC issued a direct final rule 6 modifying 10 CFR 50.2 definition of utilization 7 facility to include the SHINE irradiation units. An 8 irradiation unit consists of a subcritical assembly, a 9 neutron driver and supporting systems. Next slide, 10 please.

11 The radioisotope production facility is a 12 portion of the SHINE facility used for preparing target 13 solution, extracting, purifying, and packaging 14 moly-99, and the recycling and cleaning of target 15 solution. Based on the batch size of greater than 100 16 grams, the RPF meets the definition of a production 17 facility as defined in 10 CFR 50.2. Next slide, please.

18 SHINE submitted a construction permit 19 application in two parts pursuant to an exemption from 20 10 CFR 2.101. Part one of the application was submitted 21 on March 26, 2013 which included PSAR Chapter 2 on site 22 characteristics, PSAR Chapter 19 for the environmental 23 review, and general and financial information. Part two 24 of the application was submitted May 31st, 2013 which 25 provided the remaining PSAR chapters. And then a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

25 1 discussion of preliminary plans for coping with 2 emergencies in accordance with 10 CFR 50.34(a)(10) was 3 provided September 25th, 2013. The SHINE facility will 4 be licensed under 10 CFR Part 50, Domestic Licensing of 5 Production and Utilization Facilities. Next slide, 6 please.

7 SHINE used for regulatory guidance and 8 acceptance criteria, SHINE used NUREG-1537 guidelines 9 for preparing and reviewing applications for licensing 10 of non-power reactors, and the Interim Staff Guidance 11 augmenting NUREG-1537 Parts 1 and 2. The ISG 12 incorporated relevant guidance from NUREG-1520, a 13 Standard Review Plan for the review of a license 14 application for a fuel cycle facility. SHINE also used 15 additional guidance such as regulatory guides and ANSI 16 Standards in developing the application.

17 That ends my presentation. I'll now turn it 18 over to Eric Van Abel to discuss the SHINE technology.

19 MR. VAN ABEL: Next slide, please.

20 Good morning. I want to give a brief 21 overview of the process and technology that SHINE plans 22 on using. In this slide, as Jim showed there, there's 23 two main areas of the production facility building.

24 There's an irradiation facility, an IF, and a 25 radioisotope production facility, an RPF. I'm going to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

26 1 go through the processes in these two areas in the next 2 few slides. Next slide, please.

3 Here's a general schematic of the overall 4 SHINE process overview. Just to orient you relative to 5 the last figure, the TSV and Irradiation Unit Cell in 6 the left there is part of the irradiation facility, and 7 the other components on this diagram are all part of the 8 RPF.

9 So, we begin our process in the bottom there 10 at the target solution preparation step. In that process 11 we dissolve uranium in sulfuric acid and produce what 12 we call target solution. That target solution is then 13 moved to a hold tank which is number 2 on the figure 14 there. There's one of these hold tanks for each of our 15 eight irradiation units so there's eight hold tanks.

16 Those hold tanks are staging areas prior to the 17 irradiation cycle, so in that hold tank we'll measure 18 the uranium concentration, the pH to insure that the 19 parameters are correct to begin the irradiation cycle.

20 And then once we're ready to begin we'll start pumping 21 that solution over to the TSV in discrete batches. We'll 22 fill up the TSV to the proper level and then once the 23 TSV is at the proper level we begin the irradiation 24 process by energizing the neutron driver which is our 25 accelerator that Greg mentioned.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

27 1 That accelerator runs for approximately 2 five and a half days. We irradiate the solution, produce 3 medical isotopes of interest in the solution, and then 4 we -- once we're done with the irradiation process we 5 drain that solution to a dump tank located right in the 6 irradiation unit cell.

7 The solution is held there for a short 8 period to decay, and then once we're ready to process 9 it we transfer it over to the super cell, which is number 10 4 on the figure there. The super cell is just a larger 11 hot cell that has several processes inside a single hot 12 cell. And the first part of that process is the 13 extraction process. And that's where we actually 14 separate out the moly-99 from the other isotopes in the 15 solution.

16 And then most of the time the uranium 17 solution just goes right on to the recycle tank which 18 is number 5 in the figure. And there it's just recycled 19 back into the process and it goes in a loop. It goes to 20 another hold tank, to another irradiation cycle.

21 Occasionally, we also send it to the UREX 22 process which is item 6 in the figure there. And that's 23 where we periodically clean up the solution, we remove 24 the uranium from the other fission products using 25 solvent extraction technology UREX, and we recover the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

28 1 uranium and recycle that back into the process. So, we 2 just send that back to the target solution preparation 3 steps and recreate target solution again. Next slide, 4 please.

5 In the irradiation facility, SHINE has a 6 system that couples fusion and fission technology, so 7 we have an accelerator that's fusion-based, 8 deuterium-tritium fusion-based accelerator coupled to 9 a fission-based subcritical assembly. The little 10 diagram on the right there shows a schematic of that 11 process. In the accelerator we accelerate deuterium 12 ions into a tritium gas target. That results in the 13 production of fusion neutrons, 14 MeV fusion neutrons.

14 Those neutrons then pass through a component we call the 15 neutron multiplier. In that multiplier the yield of 16 neutrons is increased and then the neutrons are 17 transferred into the target solution. The target 18 solution is where the uranium is actually located.

19 In the target solution there's subcritical 20 multiplication so the fission occurs, it causes more 21 fission but in a subcritical process. And then that 22 fission yields the radioisotopes of interest directly 23 in the solution for ready extraction from the solution.

24 There are additional supporting systems 25 including a light water pool system. The entire system NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

29 1 is located in a pool similar to a research reactor. The 2 target solution vessel off gas system, as I'll mention 3 in a few slides here, manages the gas products from the 4 fission process. The primary closed loop cooling 5 systems cools the TSV during the irradiation process, 6 and there's a tritium purification system that supplies 7 clean gases to the accelerator for the irradiation.

8 It's important to note that this process is 9 done at essentially atmospheric pressure. It's a low 10 temperature, low pressure process. These aren't highly 11 pressurized, high temperature systems like a power 12 reactor would be. The target solution at the end of the 13 irradiation cycle is simply drained to a dump tank, as 14 I mentioned, right in the irradiation unit so that's a 15 passively cooled, safe-by-geometry tank to store the 16 solution. And that's drained through redundant 17 fail-open dump valves.

18 The TSV itself is just an annular, a simple 19 annular vessel constructed of Zircaloy, a widely used 20 alloy in the nuclear industry. And there's no pumping 21 of the solution while irradiating it. It's just 22 naturally convected inside of the vessel. Next slide, 23 please.

24 This slide shows just a rendering of the 25 subcritical assembly. The outer vessel in the center NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

30 1 there is the subcritical assembly support structure, 2 the SASS. This is a secondary vessel that surrounds the 3 TSV. The TSV is internal to that along with the neutron 4 multiplier. SASS is just there in case there's a leak 5 in the TSV, that solution would be contained inside of 6 that. The dump tank is located directly below it there, 7 and there are dump and overflow lines from the TSV to 8 the dump tank to connect it. Next slide, please.

9 So we were just looking at the components 10 in red on this figure. Directly above that is the 11 accelerator. The accelerator sits on a grating above the 12 pool and the accelerator is in yellow in this picture.

13 It's an electrostatic accelerator, a simple accelerator 14 technology. As Greg pointed out before, it generates 15 fusion neutrons from DT fusion that drive the fission 16 process. When we shut down the accelerator, the fission 17 process terminates because the subcritical assembly is 18 never at critical.

19 The tritium purification system is not 20 shown in this figure, but it's also in the irradiation 21 facility. And that system separates gases from the 22 accelerator, so the accelerator as it's operating, it's 23 mixing deuterium and tritium together. The tritium 24 purification system separates those back apart and 25 resupplies the purified tritium back to the accelerator NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

31 1 for continued operation. And the tritium lines for that 2 system and the processing equipment are in glove boxes 3 and double-walled pipe. Next slide, please.

4 The TSV off-gas system is shown in green on 5 the figure here. That system is directly adjacent to the 6 irradiation unit cells. That system contains the 7 fission product gases that are generated in the TSV 8 during irradiation. It removes iodine from the gas 9 stream, and also its major function is to recombine 10 hydrogen and oxygen. So as we irradiate the solution, 11 radiolysis of the water generates hydrogen and oxygen, 12 and this system sweeps sweep gas air over the target 13 solution vessel to dilute the hydrogen and send it to 14 a recombiner, and then recombine the water and return 15 that water back to the TSV, so it's just a closed loop.

16 The subcritical assembly, as I mentioned 17 before, is immersed in a light water pool. That pool 18 provides significant radiation shielding and decay heat 19 removal. Next slide.

20 For the irradiation process, when we're 21 ready to begin the irradiation we measure the relevant 22 parameters of the target solution, such as uranium 23 concentration, pH, any other chemical parameters that 24 we need to determine, and then we begin moving the 25 solution in discrete batches over into the target NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

32 1 solution vessel. We measure the count rate at each step 2 there and from that we can do the 1/M process that's used 3 in reactors all over the world to predict the critical 4 state of the assembly. And the difference with us is that 5 we increase volume, we predict where the critical state 6 is, and we never go there. We stop 5 percent by volume 7 below critical. And that's our highest reactivity point 8 for the system.

9 And during that process there are automatic 10 safety systems that are monitoring and will initiate a 11 shutdown on high neutron flux or primary coolant 12 temperature should the operators not stop the system 13 before that. And that would prevent a criticality. Next 14 slide, please.

15 Once we begin the irradiation process we 16 isolate that batch of uranium solution in the TSV so it's 17 a fixed target, fixed batch of solution. We close the 18 fill valves, the redundant fill valves and isolate the 19 fill pump from the system. We energize the accelerator, 20 and then we begin slowly supplying tritium to the 21 accelerator and that causes the output of the 22 accelerator to gradually increase, and that increase in 23 the neutron output of the accelerator results in 24 increased fission power in the TSV. That fission power 25 results in increased temperature and void fraction in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

33 1 the TSV which the system has very strong inherent 2 negative feedback coefficients so the increase in 3 temperature and void fraction causes reactivity to drop 4 significantly in the system. And we don't do anything 5 to compensate for the reactivity drop. We let the system 6 drive further subcritical.

7 We do this for approximately five and a half 8 days, and then following shutdown we drain the solution 9 into that dump tank where it's passively cooled.

10 Normally, we're maintaining the temperature of that 11 pool but should we lose offsite power or active cooling 12 for any reason of the pool, there's sufficient heat 13 capacity in the pool for a temperature rise of only 12 14 degrees after 90 days without cooling, so it's a large 15 body of water. There's very little decay heat because 16 this is such a small system. Next slide, please.

17 In the radioisotope production facility 18 once we're ready we transfer that solution over to the 19 RPF and there we extract the moly-99. We have a 20 purification process that it then goes to. This is the 21 LEU modified Cintichem process where it's a laboratory 22 scale glassware process that's done in the hot cell just 23 to purify the product. And then we package it and get 24 it ready for shipment to customers.

25 In the RPF there's also a noble gas removal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

34 1 system, the NGRS. This system collects those off gases 2 from the TSV off gas systems, the eight TSV off gas 3 systems, stores them, holds them for decay for 40 days 4 prior to sampling, and then a filtered monitored 5 discharge to our process vessel vent system.

6 Also in the RPF is the processes for 7 recycling and cleaning the target solution, the UREX 8 process. That's, as I mentioned before, a solvent 9 extraction process that separates the fission products 10 and plutonium from the uranium. The uranium is recovered 11 for reuse in the process. Next slide, please.

12 In the SHINE facility we used engineered 13 safety features to protect public health and safety, and 14 these are principally confinement. It's important to 15 note that our inventory in any one of these confinement 16 areas is approximately 10,000 times less than the 17 radionuclide inventory in a power reactor, so they're 18 much lower inventory which reduces the risk. And also 19 these are low temperature, low pressure processes so 20 there's not a lot of stored energy to encourage 21 dispersal, so there's lower dispersion forces which, of 22 course, reduces releases.

23 The confinement functions themselves are 24 provided by the biological shielding. There's -- over 25 most of the processes there's thick reinforced concrete NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

35 1 biological shielding, usually several feet thick 2 concrete. Isolation valves on the piping systems, 3 ventilation systems play an important role in the 4 confinement features. As shown in the figure on the 5 right there, that shows you some of our cascaded 6 ventilation zones. From Zone 1 to Zone 4 there's a 7 pressure gradient with Zone 1 being at the lowest 8 pressure, so any potential contamination is reduced 9 outside of those areas in Zone 1 where radiological 10 materials are normally stored. And in any accident 11 scenario, those areas in red on the figure there are the 12 areas where isolation would principally occur and 13 contain that material should an accident occur. And 14 also, of course, instrumentation and control systems 15 that actuate the confinement features. Next slide, 16 please.

17 So as described in SHINE's PSAR, we have a 18 preliminary design that shows that we can construct this 19 facility to meet the applicable regulatory 20 requirements. We've identified robust engineered and 21 administrative controls to ensure that we can protect 22 public health and safety, the environment, and our 23 workers, and that we are certainly designing this plant 24 with safety as our primary criterion. And that concludes 25 my presentation.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

36 1 CHAIRMAN BURNS: Does that conclude the 2 presentations?

3 MR. PIEFER: It does.

4 CHAIRMAN BURNS: Okay, thank you. Starting, 5 we'll have Commissioner questions now. We'll start 6 -- I'll start off this round of questioning.

7 Just to make sure I understand the design 8 facility laid out, each of these individual -- the eight 9 TSVs, these are essentially independent. Correct?

10 MR. VAN ABEL: Yes. Yes, they can be operated 11 independently run. We can run anywhere from zero to 12 eight of them.

13 CHAIRMAN BURNS: Okay. So, there's no real 14 interconnection between them.

15 MR. VAN ABEL: There are some shared 16 systems, like the ventilation system is common to them.

17 There's a common chilled water system that's supplying 18 chilled water to the heat exchangers.

19 CHAIRMAN BURNS: Okay.

20 MR. VAN ABEL: But the individual primary 21 cooling systems are unique for each one.

22 CHAIRMAN BURNS: Okay, thank you.

23 A couple of questions. Could you give me an 24 idea of what level of public engagement you had in terms 25 of the site selection process for the facility, and the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

37 1 type of feedback you got from that? I guess, Mr. Piefer, 2 that might be for you.

3 MR. PIEFER: Yes. I actually would like to 4 call Katrina Pitas to the witness stand.

5 CHAIRMAN BURNS: Okay.

6 MR. PIEFER: She's got that pretty 7 thoroughly. Are you ready?

8 MS. PITAS: I think so.

9 MR. PIEFER: Okay.

10 CHAIRMAN BURNS: Well, come -- Ms. Pitas, 11 come up to the podium here. And what I'd ask you to do, 12 and just for other witnesses, when you come up identify 13 yourself, your position. And I remind you you're -- and 14 I presume you took the oath. Yes, I saw you take the oath, 15 and you remain under oath.

16 MS. PITAS: Thank you.

17 CHAIRMAN BURNS: So, thanks.

18 MS. PITAS: So, my name is Katrina Pitas. I'm 19 the Vice President of Business Development for SHINE.

20 Our site selection process involved 11 21 criteria which I'd be happy to go through, but in terms 22 of public involvement, the individual community 23 governments that we were working with during the later 24 stages of our site selection process were very -- we had 25 a very good relationship with all three of the sites that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

38 1 we considered, the specific sites that we considered.

2 And then once we chose Janesville, that relationship has 3 continued to grow, and we believe we have a very good 4 relationship with that community. And I'd be happy to 5 go into some of the actions we've taken to ensure a good 6 relationship with the community, if you'd like.

7 CHAIRMAN BURNS: Well, I just -- yes, 8 briefly.

9 MS. PITAS: Sure. So, once we chose 10 Janesville, we set up twice yearly public meetings that 11 were open to the entire community. They were just 12 informational sessions where Greg would give a 13 presentation on our progress, the type of facility, and 14 what the company was aiming to do in the community. And 15 then we also have recently started giving twice yearly 16 updates to the city council which are open sessions, so 17 that makes a total of four times a year we meet directly 18 with the community. It's open to anyone to ask whatever 19 questions they have, voice concerns. And the result of 20 that has been truly -- a relationship based on mutual 21 respect and trust. So, it's been very positive.

22 CHAIRMAN BURNS: Thank you very much.

23 The other question I have goes to the nature 24 of what the application is for, which is a construction 25 permit. As I noted earlier, more recently the Commission NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

39 1 has been -- has held hearings on Combined Licenses which 2 is by intention a more comprehensive review, maybe not 3 more comprehensive but it's a broader scope of review 4 because it is actually the construction permit and the 5 ultimate operating 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 current 9 generation of operating plants in the U.S., going 10 through the construction permit process allows some 11 completion of certain design features, updating all 12 that.

13 Could you give me sort of a feel of, if a 14 construction permit is issued, what are, in effect, the 15 things you would see that need to be worked on from a 16 design perspective before we come to the next phase, 17 which would be the operating license? What are the 18 things that are still, in a sense, open? And I don't mean 19 open in a negative way, but it's the idea that the 20 Applicant may have some design issues that it needs to 21 address and to resolve prior to a final determination 22 on operating license.

23 MR. HENNESSY: I'll take this one. This is 24 Bill Hennessy, the Engineering Manager.

25 The state of our design right now is a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

40 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 design 15 from paper to the actual facility and all that.

16 MR. HENNESSY: 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 was 24 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

41 1 about. This is a significant new facility and capability 2 for that kind of a more agricultural and rural area. I 3 appreciate that you have done a lot of community 4 education and awareness of this activity. I might 5 suggest to you that if the construction permit is issued 6 and large-scale construction activities start taking 7 place, I think you might have to cover some of the same 8 territory because that's when the community really 9 becomes engaged and very interested when they start 10 noticing all of that activity. And then they will -- a 11 number of them I'm sure will begin their inquiry into 12 exactly what you're doing there. So, it's good that 13 you've got the structure in place to begin to educate 14 and communicate with people about what it is that you 15 are undertaking.

16 I note also, this is an overview panel so 17 I'm going to ask some questions that may or may not have 18 a direct relevance to the findings that the Commission 19 will make in order to make a decision on authorizing the 20 construction permit per se.

21 You provided in your overview presentation 22 some NEA statistics on the projected growth in the use 23 of the product that would come out of the SHINE facility.

24 I don't believe, though, that those projections give any 25 indication of the great swaths of the globe where people NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

42 1 are medically under-served and so it doesn't really 2 capture upon the demonstration of a new technology that 3 doesn't use HEU the potential long term maybe to have 4 more penetration of these types of diagnostic 5 techniques where arguably in medically under-served 6 areas of the globe they could do even greater good than 7 they do in areas that have access to a lot of 8 alternatives, or perhaps more invasive procedures.

9 So, it is interesting that there is a large 10 public good that comes out of constructing a facility 11 like this. Of course, that cannot have a direct bearing 12 on a safety determination. The facility, you know, 13 either is or isn't going to be safely operated, so we 14 have to set that aside. But in my preparation for the 15 mandatory hearing today on the construction permit I 16 couldn't help but think that if any of the SHINE 17 witnesses are fans of Monty Python, it's the opportunity 18 to say "And now for something completely different." So, 19 the Chairman has made reference to the fact that we've 20 been looking a lot at power reactor mandatory hearings, 21 so this was a chance to wrap our minds around something 22 that is very different.

23 It's commendable for the NRC Staff, and 24 I'll make this point in their overview presentation.

25 They've used what I call an adaptive process, meaning NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

43 1 there was no part of the Code of Federal Regulations that 2 SHINE or the NRC Staff could turn to and say oh, for this 3 type of medical isotope production, here is the 4 regulatory framework. So, as you look forward there are 5 elements of your design that are not complete, there is 6 a research and development program and plans that you 7 have to close on technical uncertainties that the NRC 8 Staff has, of course, reviewed. And that is part of their 9 finding is to see that you have plans and programs in 10 place to complete and answer questions about areas of 11 technical uncertainty.

12 But would SHINE assess -- as the Applicant, 13 do you assess that this adaptive process, a kind of going 14 to things, guidance, regulations that we have in place, 15 deciding which portions of those standing procedures 16 and regulations were or were not relevant to the 17 technology you were proposing, and then applying that 18 and going through a Request for Additional Information 19 process? Would you say that you found that process 20 workable to get through this construction permit stage?

21 And what would you offer in terms of your confidence in 22 continuing to pursue that kind of adaptive process at 23 the operating license stage? And embedded in that, could 24 you address what percent of design do you think you are 25 complete, if you had to put a number on it?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

44 1 MR. PIEFER: So, I think the answer is yes, 2 and I'm going to turn it over to Jim to do a little bit 3 more comments on the process.

4 MR. COSTEDIO: I think the process is very 5 workable. All the way through we've met several times 6 with the Staff, we've had public meetings to work 7 through some of the issues, you know, you talked about 8 that the code doesn't specifically in all cases clearly, 9 I mean, address us, but we were able to work through that 10 during the public meetings with the Staff.

11 COMMISSIONER SVINICKI: Do you see it 12 basically carrying forward into the -- if the 13 construction permit is issued, do you see this same 14 process basically carrying forward in the same form to 15 the operating license phase?

16 MR. COSTEDIO: Absolutely.

17 COMMISSIONER SVINICKI: Okay. And would you 18 say then that in terms of uncertainties for you going 19 forward, you do have certain proof of concept and 20 technical issues that you have plans in place to close 21 on. There's also regulatory uncertainty that exists at 22 some level. Would you say regulatory uncertainty or 23 technical and proof of concept uncertainty, which of 24 those would dominate the uncertainty going forward for 25 you, or perhaps it's financial?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

45 1 MR. COSTEDIO: I would think the regulatory 2 uncertainty.

3 MR. PIEFER: Yes, of those two, I would 4 agree. I think the -- we've done enough technology 5 demonstrations at this point, including a recent demo 6 where General Electric made injectable drugs out of our 7 process, and they looked beautiful. So, we feel pretty 8 confident in the technology at this point. There's a few 9 things outstanding in terms of longevity of the plant, 10 et cetera, that are being worked on as we go forward; 11 corrosion studies, for example, that we're going to be 12 interested in finding out the data there. But, you know, 13 timeline and financing, you know, you mentioned 14 financing uncertainty. Those two are tied hand and hand, 15 and so that's another thing, we're in a hurry. We've got 16 to do it right, but obviously given the exit of the 17 reactors we'd like to move as quickly as possible. And 18 up until now, you know, we've been able to move this 19 project forward in a largely serial fashion, which is 20 eliminate risks, perceived risks from investors, and 21 then move forward and get the next slug of money.

22 COMMISSIONER SVINICKI: Can I ask on that 23 point, the draft construction permit, or the 24 construction permit if issued includes a date by which 25 construction would complete. Do you have a notional time NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

46 1 frame by which you anticipate beginning construction?

2 In a non-proprietary basis, is that something you could 3 share in this open meeting?

4 MR. PIEFER: Yes, I think so. I mean, what 5 does the schedule currently say?

6 MR. COSTEDIO: Spring of 2017.

7 MR. PIEFER: Spring of 2017.

8 MR. COSTEDIO: And we would follow with the 9 OL application about three months later.

10 COMMISSIONER SVINICKI: Okay. And then the 11 last question I had was, I'm not familiar, though, with 12 the airport facility that would be your nearest 13 facility. Is that a cargo hub, or is it -- what size of 14 aircraft -- how active is that facility? Would you have 15 dedicated flights out of there?

16 MR. HENNESSY: We might have dedicated 17 flights out of there. That's certainly one thing we're 18 considering, using a carrier that would provide service 19 from that area.

20 COMMISSIONER SVINICKI: Is the airport 21 facility currently adequately sized for your projected 22 needs, or are there upgrades to the airport itself?

23 MR. HENNESSY: It would be sized for our 24 needs, yes.

25 COMMISSIONER SVINICKI: Okay.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

47 1 MR. PIEFER: It's not used for much other 2 than recreational flying.

3 COMMISSIONER SVINICKI: I was surprised, 4 frankly, again it was a long time ago, but having lived 5 in an adjacent county, I was surprised that there even 6 was an air facility there. I didn't recall that. Okay, 7 thank you for that. Thank you, Mr. Chairman.

8 CHAIRMAN BURNS: Thank you, Commissioner.

9 Commissioner Ostendorff.

10 COMMISSIONER OSTENDORFF: Thank you, 11 Chairman. Thank you all for your presentations this 12 morning.

13 I appreciate that my colleagues have 14 already highlighted that this is a very different type 15 of hearing than we've had under our Part 52 hearings, 16 so having that philosophical mind set change by your 17 comments was very helpful there, Chairman and 18 Commissioner Svinicki.

19 I guess this is a question. I think that 20 Commissioner Svinicki may have asked this, I may have 21 missed the answer, but a question that came up about the 22 overall characterization of design completion. What can 23 you say about that?

24 MR. HENNESSY: I'll take that question. We 25 debate this amongst ourselves quite a bit, as you can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

48 1 imagine. The characterization of design complete is 2 variable depending on the systems you're looking at.

3 Some systems are pretty far along like our tritium 4 purification system, and others are still back at 5 conceptual. Where those systems we know we can fill in 6 quickly with, design what we need to, like HVAC. So, 7 overall, I would say the percent design complete is 8 around 15 percent, which I believe is appropriate for 9 being able to say that we've completed preliminary 10 design.

11 COMMISSIONER OSTENDORFF: Okay. So, let me 12 just stay with you there for a minute on the design 13 piece. I appreciate there's first-of-a-kind 14 engineering issues here, there's some things that have 15 not been attempted before. What are the top two or three 16 areas, sub-components, is it the TSV, is it the hot super 17 cell? I'm curious as to where do you see the most 18 difficult challenges ahead on the design completion?

19 MR. HENNESSY: We have prototypes built in 20 our lab in Monona, and we're continuing to evolve the 21 TSV design, and the TOGS design, and doing testing on 22 components. And I think that's going on pretty well. I 23 think Eric can comment on that some more.

24 COMMISSIONER OSTENDORFF: As you answer 25 this question, can you please maybe give a little more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

49 1 detail on what you have in the form of prototype, 2 mockups, or simulations?

3 MR. HENNESSY: Sure. I'll turn that over to 4 Eric.

5 MR. VAN ABEL: Yes. We have -- each of these 6 components in that overall process diagram, each of 7 those components has been demonstrated individually 8 either by SHINE, by Phoenix Nuclear Laboratories who's 9 the accelerator provider, or by the National 10 Laboratories. You know, the TSV off-gas system, the one 11 that recombines the hydrogen, that system we have a 12 full-scale prototype in our facility in Monona where 13 we've demonstrated full-scale hydrogen recombination 14 testing flow rates, droplet pickup, various things of 15 engineering interest. We have a tritium purification 16 system prototype in our Monona facility constructed by 17 Savannah River National Lab. We have an accelerator in 18 the Monona facility that we share with Phoenix Nuclear 19 Labs that's demonstrated the full production scale 20 accelerator technology. The TSV, we have a mockup TSV.

21 We can't, obviously, put uranium solution in it, but we 22 have a mockup TSV demonstrating -- that's connected to 23 the TOGS system to demonstrate that that system combined 24 performance. And then Argonne National Laboratory is 25 doing experiments on the extraction and purification of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

50 1 our solution, so they've irradiated what they call a 2 mini-SHINE experiment, which is essentially a system 3 very similar to ours from a chemical standpoint of 4 uranyl sulfate solution irradiated by an accelerator.

5 They process it through our same extraction 6 technologies, our same purification technologies that 7 we plan to use. And as Greg mentioned before, they've 8 shipped product to one of our expected customers and 9 demonstrated that it met the purity specifications that 10 we plan to meet.

11 COMMISSIONER OSTENDORFF: If you had to draw 12 a comparison between your preliminary design for the 13 SHINE facility and some existing facilities, 14 irrespective of location, are there a couple of 15 facilities that you think you've borrowed from -- I'm 16 not talking about from an intellectual property 17 standpoint, but just as far as known processes or 18 procedures? I'm trying to figure out what's the analogy, 19 if there are any analogies, as to what other existing 20 facilities might be somewhat comparable in some aspects 21 to yours?

22 MR. VAN ABEL: Yes. So, for the TSV, this is 23 a subcritical assembly, it doesn't go critical, but it 24 shares a lot of the physics and thermal-hydraulic 25 characteristics of aqueous homogenous reactors, AHRs.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

51 1 Those have been built and tested at several facilities.

2 The SUPO reactor at Los Alamos National Lab is one we 3 use a lot for validation. SILENE reactor, the homogenous 4 reactor experiment done at Oak Ridge, HRE reactor. All 5 these facilities we are using their operational 6 history, transient analysis from them to validate our 7 codes to ensure that our codes adequately predict the 8 TSV behavior. Working with Los Alamos National Lab on 9 that, so we borrowed, essentially, how they ran their 10 facilities and operated those AHRs really to feed the 11 design of the TSV.

12 The accelerator, as we mentioned, we have 13 a full-scale prototype of that accelerator already. And 14 the LEU modified Cintichem process that we use for 15 purification, that's based -- that originated at the 16 Cintichem facility, which is an NRC -- previously 17 NRC-licensed facility that produced moly-99 for 18 commercial sale. There they used a typical solid fuel 19 reactor to irradiate solid targets, but then they 20 dissolved them, and processed them, and purified them 21 similar to our technology, so we've looked at that 22 Cintichem facility and use that technology in our 23 facility, as well, for the processing side.

24 COMMISSIONER OSTENDORFF: Thank you. That 25 was very helpful. Thank you, Chairman.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

52 1 CHAIRMAN BURNS: Thank you, Commissioner.

2 Commissioner Baran.

3 COMMISSIONER BARAN: Welcome. Thanks for 4 being here, and for your presentations.

5 Following up on this distinction between 6 the construction permit application and the operating 7 license application, I'm interested in hearing a little 8 bit about how you decided what level of information to 9 include in the construction permit application. When 10 drafting the application, how did you weigh the benefits 11 of having more issues reviewed by the Staff early in the 12 process against having more flexibility during 13 construction, if you were to receive a construction 14 permit?

15 MR. COSTEDIO: Well, we provided the 16 principal design criteria, and the design basis of the 17 structure, systems, and components. From that we were 18 able to do our accident analysis, and the results of the 19 accident analysis shows we're within regulatory limits, 20 within the Part 20 limits. Our definition of 21 safety-related implements those requirements on 10 CFR 22 20 and Part 70.61 for the performance requirements. So, 23 you know, we believe that we've provided the necessary 24 information to obtain the construction permit.

25 COMMISSIONER BARAN: In the final ACRS NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

53 1 letter to the Commission, the ACRS raised seven topics 2 to be further addressed in the application for an 3 operating license. Pre-hearing Question 4, explored 4 this issue, and your response indicated that these 5 topics are not included as commitments in Appendix A of 6 the Safety Evaluation Report. How will SHINE ensure that 7 the ACRS topics will be addressed at the operating 8 license stage?

9 MR. COSTEDIO: All of those topics are 10 included -- we issue what we call Issue Management 11 Reports, which are contained in our Corrective Action 12 Program. And every one of them is being tracked to be 13 included in the operating license application.

14 COMMISSIONER BARAN: Okay, thank you.

15 Although the SHINE facility is not a 16 reactor, part of the licensing basis for the 17 construction permit utilizes design principles from the 18 general design criteria for nuclear power plants. Can 19 you clarify the process you used to determine which 20 general design criteria are applicable to the SHINE 21 facility?

22 MR. HENNESSY: We reviewed all of the 23 general design criteria as outlined in our PSAR when we 24 were looking at the preliminary design, and the PSAR 25 also contains a description of how each of those GDC NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

54 1 would apply to SHINE, or how it's integrated into our 2 design, so we actually reviewed all of them.

3 COMMISSIONER BARAN: Okay. So, you went 4 through them all systematically and assessed whether 5 each one would apply in concept at least to this 6 facility.

7 MR. HENNESSY: Yes.

8 COMMISSIONER BARAN: Okay, thank you. Thank 9 you, Mr. Chairman.

10 CHAIRMAN BURNS: Thank you, Commissioner.

11 I want to thank the Applicant's panel for 12 their presentations. We'll now proceed with the 13 Overview Panel from the NRC Staff. I'll ask the 14 witnesses please come forward, yes.

15 Okay. Again, this will be the Overview 16 Panel, or an overview from the Staff Panel with respect 17 to the application. I'm going to remind the witnesses 18 you're under oath, and did you all take the oath?

19 WITNESSES: Yes, sir.

20 CHAIRMAN BURNS: Okay. And, again, assume 21 that the Commission is familiar, generally familiar 22 with the pre-hearing filings from the Staff and the 23 Applicant. And I will ask the panelists to introduce 24 themselves. Ms. Gavrilas.

25 MS. GAVRILAS: Mirela Gavrilas, Division of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

55 1 Policy and Rulemaking in NRR.

2 MS. MARSHALL: Jane Marshall. I'm the Deputy 3 Director for the Division of License Renewal in NRR.

4 MR. DEAN: Bill Dean, Director of Office of 5 Nuclear Reactor Regulation.

6 MS. BAILEY: Marissa Bailey. I'm the 7 Director for the Division of Fuel Cycle Safety 8 Safeguards and Environmental Review in NMSS.

9 CHAIRMAN BURNS: Okay, thank you. And let 10 the Staff proceed.

11 MR. DEAN: Okay. Good morning, Chairman, 12 Commissioners. We're pleased to be here with you this 13 morning to provide testimony associated with the 14 application for a construction permit submitted by 15 SHINE Medical Technologies for a medical radioisotope 16 irradiation and production facility.

17 What you'll hear from this panel is an 18 overview of the Staff's review methodology, as well as 19 highlighting some of the technical and environmental 20 review aspects of it. Essentially, we'll be setting the 21 stage for the panels that you'll have later today on both 22 the technical and environmental aspects of the review.

23 Could I have the next slide, please.

24 So, I'm not going to spend much time on this 25 slide. I think the SHINE representatives did a very good NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

56 1 job in terms of setting the stage for the importance of 2 moly-99 production, benefits of the technetium-99 3 metastable as an important radioisotope for medical 4 diagnostic procedures. I think they also set the stage 5 in terms of how much this radioisotope is used in both 6 the United States and globally, so I think they set a 7 pretty good stage for why it's important that we pursue 8 domestic supply, particularly with the Canadian 9 facility scheduled to shut down in 2018, as well as the 10 challenges that have existed at some of the foreign 11 facilities with interruptions in supply because of 12 extensive shutdowns for maintenance activities and so 13 on. So, I think we have a pretty good case for why it's 14 important domestically that we have a moly-99 15 production facility. Next slide, please.

16 So, national policy objectives which 17 support domestic production capabilities really have 18 three major components to them. One is to assure that 19 we have a reliable source of moly-99 production.

20 Secondly, that it's not utilizing highly enriched 21 uranium in producing the moly-99, as well as no market 22 subsidies. Those are three aspects of the national 23 objectives associated with moly-99 production 24 domestically.

25 We have -- DOE's National Security NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

57 1 Administration has engaged in cost-sharing agreements 2 with various organizations, and SHINE Medical 3 Technologies is one of those in terms of helping to 4 develop moly-99 production capability. As the SHINE 5 representatives noted, they plan on utilizing a uranium 6 fission process utilizing low enriched uranium in an 7 aqueous homogeneous reactor, and then chemically 8 separating the moly-99 in a radioisotope production 9 facility.

10 I think the important thing here is that 11 from a Staff perspective, our review is consistent with 12 the national policy, and conforms with the Atomic Energy 13 Act, and all the applicable regulations. Next slide, 14 please.

15 We've been preparing for the SHINE review, 16 and actually review of any medical radioisotope 17 facility for some time. Back in 2009, we formed an 18 interoffice working group that contributed substantial 19 technical and regulatory diversity and expertise in 20 terms of developing approaches that we would consider 21 if and when we got a production facility application.

22 Back in 2012, we created a Interim Staff 23 Guidance document that was specifically focused on 24 aqueous homogeneous reactors to support and supplement 25 the SRP or the Standard Review Plan for research and test NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

58 1 reactors. And this is the products that the SHINE 2 facilities have utilized in terms of developing their 3 construction application.

4 We've had a number of public meetings with 5 engaged stakeholders. This includes, obviously, the 6 SHINE management and staff, public individuals, as well 7 as federal, state, and local governments. These 8 meetings have been focused on the technical, the 9 regulatory, and the environmental review aspects of the 10 SHINE facility. We also have coordinated our review with 11 federal, state, and local governments. So, for example, 12 NNSA from DOE has been involved, the Environmental 13 Protection Agency, the National Fish and Wildlife 14 Foundation, and the Advisory Council on Historical 15 Preservation. And at the state and local levels, the 16 State of Wisconsin Department of Health Services, and 17 the Janesville City Council has been significantly 18 involved with us in terms of some of the review aspects.

19 Next slide, please.

20 So, at this point I'd like to turn it over 21 to Mirela who will discuss the Staff's review of the 22 SHINE construction permit.

23 MS. GAVRILAS: Thank you, Bill.

24 In 2013, SHINE submitted a two-part 25 application for a construction permit under 10 CFR Part NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

59 1 50. If granted, the permit will allow SHINE to construct 2 a medical radioisotope production facility in 3 Janesville, Wisconsin. SHINE's application only seeks 4 authorization to construct the proposed SHINE facility; 5 therefore, the 10 CFR Part 50 regulations require less 6 detail than for an operating license or a Combined 7 License application.

8 The necessary elements of a construction 9 permit application are provided in Section 50.34 and 10 include a preliminary design of the facility, a 11 preliminary analysis of structures, systems, and 12 components, probable subjects of technical 13 specifications, a preliminary emergency plan, a quality 14 assurance program, and ongoing research and 15 development.

16 SHINE will submit the Final Safety Analysis 17 Report, or FSAR, with their operating license. The FSAR 18 will include SHINE's final design, plans for operation, 19 emergency plan, technical specification, and physical 20 security plan. Next slide, please.

21 The Staff's evaluation of SHINE's 22 construction permit application consisted of two 23 concurrent reviews. One, of SHINE's Preliminary Safety 24 Analysis Report, or PSAR, and the other of SHINE's 25 environmental report. I will discuss the Staff's safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

60 1 review, and Jane Marshall will discuss the Staff's 2 environmental review.

3 The Staff's safety review assessed the 4 sufficiency of the preliminary design. This includes 5 the principal design criteria and the design basis of 6 SHINE's proposed medical radioisotope facility. The 7 SHINE facility consists of an irradiation facility, or 8 IF, and a Radioisotope Production Facility, or RPF. Next 9 slide, please.

10 From the Staff's perspective, SHINE's 11 irradiation facility and radioisotope production 12 facility rely on novel and unique technology.

13 Therefore, the Staff tailored its activities and 14 coordinated with offices throughout the Agency to 15 ensure an informed and efficient review.

16 SHINE's irradiation facility consists of 17 eight subcritical operating assemblies or irradiation 18 units. Each irradiation unit is a 10 CFR Part 50 19 utilization facility. While not reactors, irradiation 20 units are similar to research reactors.

21 SHINE's proposed radioisotope production 22 facility consists of three super cells for the 23 separation of molybdenum-99 from irradiated target 24 solution. The RFP is a 10 CFR Part 50 production 25 facility. However, the RFP has physical and chemical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

61 1 processes similar to existing fuel cycle facilities.

2 For both the irradiation facility and the radioisotope 3 production facility, the Staff used the Commission's 4 regulations and existing guidance to determine 5 acceptance criteria that demonstrate compliance with 6 regulatory requirements.

7 The Staff's safety evaluation for both the 8 irradiation facility and the radioisotope production 9 facility was informed primarily by NUREG-1537 which is 10 the Standard Review Plan for research and test reactors.

11 The Staff augmented NUREG-1537 with Interim Staff 12 Guidance or ISG for evaluating aqueous homogenous 13 systems and production facilities. The Staff also 14 assessed the preliminary design to have reasonable 15 assurance that SHINE's final design will conform to the 16 design basis. Next slide, please.

17 An important part of the Staff's review was 18 to determine what additional technical and design 19 information beyond SHINE's initial PSAR was necessary 20 to support the evaluation of the construction permit 21 application. The Staff issued Requests for Additional 22 Information and SHINE supplemented its application.

23 After reviewing the application as 24 supplemented, the Staff found that SHINE provided all 25 the information necessary for the Staff to complete its NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

62 1 safety review for the purposes of issuing a construction 2 permit. However, the Staff identified certain areas 3 where additional information is required before 4 construction is complete. The Staff is, thus, 5 recommending construction permit conditions.

6 The conditions require SHINE to provide 7 periodic updates on the design of certain features 8 related to criticality safety and radiation protection.

9 These updates are consistent with 10 CFR 50.35. They 10 are intended to confirm that SHINE's final design will 11 conform to the PSAR design basis. For example, SHINE has 12 proposed a criticality alarm system in the radioisotope 13 production facility. A shielding wall will surround the 14 criticality alarm system. The Staff believes that 15 before construction is complete, SHINE must establish 16 the appropriate shielding wall thickness because if the 17 shielding is too thick, the alarm system will not 18 perform as required. If the shielding is too thin, 19 radiation protection will become a concern.

20 In instances where additional information 21 may reasonably be left for later consideration, SHINE 22 has made commitments to provide such information in the 23 FSAR. These commitments are listed in Appendix A of the 24 Safety Evaluation Report, or SER. The Staff will verify 25 that necessary information has been provided during the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

63 1 review of SHINE's operating license application.

2 The Staff's SER also initially proposed 3 conditions related to the Preliminary Amendment Request 4 process. However, as noted in our answers to pre-hearing 5 questions, the Staff has determined that this process 6 is better suited for construction based on a final 7 facility design. As such, the Staff no longer recommends 8 these conditions. The Staff finds that the existing 9 regulations in 10 CFR 50 are sufficient to accommodate 10 changes to the SHINE facility as the design matures.

11 Next slide, please.

12 I will now turn over the presentation to 13 Jane Marshall for an overview of the SHINE environmental 14 review.

15 MS. MARSHALL: Thank you, Mirela.

16 The environmental review for the SHINE 17 construction permit application was performed in 18 accordance with the National Environmental Policy Act 19 of 1969, commonly referred to as NEPA. NEPA established 20 a national policy for considering environmental impacts 21 and requires federal agencies to follow a systematic 22 approach in evaluating potential impacts, and to assess 23 alternatives to the proposed action. The NEPA process 24 also involves public participation and public 25 disclosure.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

64 1 10 CFR Part 51 contains NRC's environmental 2 regulations which implement NEPA. These regulations 3 describe when the Staff should prepare an Environmental 4 Impact Statement or EIS. The NRC's regulations did not 5 require the preparation of an EIS for SHINE's 6 application; however, the Staff determined that an EIS 7 would be appropriate because SHINE is a first-of-a-kind 8 application for medical radioisotope production 9 facility with a unique application of technologies and 10 an EIS would allow several opportunities for public 11 involvement in the environmental review process.

12 Ultimately, the purpose of the 13 environmental review is to identify the environmental 14 impacts of constructing, operating, and 15 decommissioning the proposed SHINE facility, as well as 16 alternatives to the SHINE facility, and in combination 17 with the safety review, inform the Staff's 18 recommendation to the Commission whether or not to issue 19 the construction permit. Next slide, please.

20 The Staff began the environmental review 21 with a scoping process to gather input from the public, 22 other government agencies, and tribes on the necessary 23 scope for the EIS. The Staff conducted an Environmental 24 Site Audit to view the environmental features at the 25 proposed site and the alternative sites, and met with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

65 1 SHINE's technical specialists that developed the 2 environmental report. The Staff also developed Requests 3 for Additional Information to clarify aspects of 4 SHINE's environmental report and to seek additional 5 information not included in SHINE's environmental 6 report.

7 The Staff developed a Draft EIS based on the 8 Staff's independent review, information in the 9 environmental report, answers to the Staff's Request 10 for Additional Information, and input received during 11 the scoping process and Environmental Site Audit. The 12 Draft EIS was published for comment in May of 2015. The 13 Staff responded to all comments received in the Final 14 EIS which was published in October 2015. The Staff also 15 updated the Final EIS based on in-scope comments and 16 newly available information. Next slide, please.

17 The proposed site is currently an 18 agricultural field which has been previously disturbed 19 from decades of agricultural activities, and is 20 currently zoned for light industrial use. The proposed 21 site does not contain any surface water features, 22 threatened or endangered or candidate species, or 23 historical or cultural resources. The Staff determined 24 that the impacts to all resource areas, except for 25 traffic, would be small. The impacts to traffic would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

66 1 be small to moderate because of the noticeable increase 2 in average daily traffic flow. Next slide, please.

3 I will now turn the presentation over to 4 Marissa Bailey to discuss the Staff's regulatory 5 findings supporting its recommendation that SHINE be 6 issued a construction permit.

7 MS. BAILEY: Thank you, Jane. And I'm on 8 Slide 13, and as Jane mentioned, I'll be discussing the 9 Staff's findings to support issuance of a construction 10 permit.

11 Section 103 of the Atomic Energy Act 12 authorizes the Commission to issue licenses to 13 utilization and production facilities subject to the 14 Commission's regulations. The principal regulatory 15 requirements for utilization and production facilities 16 are in 10 CFR Part 50.

17 After completing the environmental and 18 safety reviews, the Staff has determined that SHINE's 19 application met the applicable requirements of 10 CFR 20 Parts 20, 50, and 51. Also, because processes and 21 hazards are similar to fuel cycle facilities, the Staff 22 determined the performance requirements in 10 CFR 70.61 23 can be used to demonstrate adequate safety for the 24 radioisotope production facility. Slide 14, please.

25 The Staff's review supports the four NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

67 1 findings in 10 CFR 50.35 for issuance of a construction 2 permit. The first finding is that the Applicant has 3 described the proposed design of the facility. The Staff 4 used 10 CFR 50.34(a) and our guidance to evaluate the 5 sufficiency of the preliminary design making sure that 6 SHINE's proposed design basis and criteria are 7 consistent with policy regulations and guidance.

8 SHINE committed to design the facility to 9 meet the operational safety requirements in 10 CFR Part 10 20, and the accident consequence and likelihood 11 criteria in the Interim Staff Guidance augmenting 12 NUREG-1537. SHINE designated safety-related 13 structures, systems, and components that will be 14 provided for the protection of the health and safety of 15 the public.

16 The second finding is that the Applicant 17 has identified technical or design information that can 18 be reasonably left for the Final Safety Analysis Report.

19 The Preliminary Safety Analysis Report identified such 20 information. This includes the security and safety 21 emergency plans, facility operating procedures, and 22 certain design information that SHINE committed to 23 provide in the Final Safety Analysis Report.

24 The third finding is that the Applicant has 25 identified safety features that required further NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

68 1 research and development, and SHINE has done that. SHINE 2 has ongoing research and development activities related 3 to irradiation and corrosion testing, and precipitation 4 studies. These tests are being performed by Oak Ridge 5 and Argonne National Laboratories respectively.

6 The fourth finding is, one, for those 7 safety questions and SHINE's research programs, Staff 8 has reasonable assurance that SHINE will be able to 9 complete the research programs before the latest date 10 of construction. And, two, taking into consideration 11 the site criteria contained in 10 CFR Part 100, the 12 proposed facility can be constructed and operated 13 without undue risk to the public. And with respect to 14 that fourth finding, SHINE has stated that the latest 15 date of their construction would be December 31, 2022.

16 Based on the schedule SHINE has given us, we're 17 expecting that the research programs will be completed 18 before this date. Also, the additional permit 19 conditions related to criticality safety and radiation 20 safety must be satisfied before the completion of 21 construction.

22 The site criteria in Part 100 applied to 23 power reactors and testing facilities, and not to 24 SHINE's, but the Staff considered similar site-specific 25 conditions and external events. The Staff's review NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

69 1 confirmed that the radiological releases during normal 2 and abnormal conditions will be within the 10 CFR Part 3 20 dose limits. Thus, we find that the proposed facility 4 can be constructed and operated at the proposed location 5 without undue risk to the health and safety of the 6 public.

7 Additionally, the Staff concludes that for 8 the purpose of issuing a construction permit, it 9 conducted a thorough and complete environmental review 10 sufficient to meet the requirements of NEPA and adequate 11 to inform the Commission's action on the construction 12 permit request. Slide 15, please.

13 Based on these findings, the Staff 14 concludes that there is sufficient information for the 15 Commission to issue the subject construction permit to 16 SHINE as guided by the following considerations in 10 17 CFR 50.40 and 50.50. First, there is reasonable 18 assurance that the construction of the SHINE facility 19 will not endanger the health and safety of the public, 20 and that construction activities can be conducted in 21 compliance with the Commission's regulations.

22 Second, SHINE is technically and 23 financially qualified to engage in the construction of 24 its proposed facility. Third, the issuance of a 25 construction permit for the facility would not be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

70 1 inimical to the common defense and security, or to the 2 health and safety of the public. Fourth, after weighing 3 the environmental, economic, technical and other 4 benefits of the facility against environmental and 5 other costs and considering reasonable available 6 alternatives, the issuance of this construction permit 7 is in accordance with Subpart A of 10 CFR Part 51, and 8 all applicable requirements have been satisfied. And 9 fifth, the application meets the standards and 10 requirements of the Atomic Energy Act and the 11 Commission's regulations, and that notifications to 12 other agencies or bodies have been duly made. Slide 16, 13 please.

14 The Staff will discuss novel aspects of its 15 review of the SHINE construction permit application.

16 Safety Panel 1 will discuss the unique licensing 17 considerations. Safety Panel 2 will follow with details 18 of the Staff's accident analysis. And, finally, the 19 Environmental Panel will provide a summary of the 20 process for developing the Environmental Impact 21 Statement.

22 This concludes the Staff's remarks in the 23 Overview Panel. We're prepared to respond to any 24 questions you may have at this time. Thank you.

25 CHAIRMAN BURNS: Okay. I want to thank the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

71 1 Staff Panel. We'll begin this round of questioning with 2 Commissioner Svinicki.

3 COMMISSIONER SVINICKI: Well, good morning, 4 and thank you to the NRC Staff witnesses, and all the 5 NRC Staff that contributed to the review which is the 6 topic of our evaluation and consideration here today.

7 I should have been born in Missouri, I 8 guess, because I'm the kind of person that I don't really 9 judge things by what people tell me they're capable of, 10 or what they say they plan to do, but what they actually 11 perform, how they actually perform, and what they 12 actually do. You know, the Chairman was talking in his 13 opening remarks about some of the significant licensing 14 work that the NRC Staff has undertaken this year. We've 15 had a number of mandatory hearings, and there are many 16 tens of thousands of NRC Staff hours that go into that 17 review, not just licensing staff, but legal, and a lot 18 of other support organizations support that work.

19 I think if we look at, in particular, Watts 20 Bar 2 operating license and in the Staff's work in 21 support of the findings they've made for issuance of 22 this construction permit, an interesting thing has 23 happened. And, again, I -- you know, these days with the 24 news such as it is, I'll turn over every rock and look 25 for some good news, so you can fault me for that, if you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

72 1 want. But there are many questions being asked about the 2 NRC's potential readiness to look at novel reactor 3 technologies. And I think if we looked at the kind of 4 work and adaptation and agility that had to be 5 demonstrated in the Watts Bar 2 history which had a very 6 unique history in terms of the run-up, the many decades 7 run-up to the issuance of that operating license. And 8 then if we complement that with the Staff's work here 9 in looking at the SHINE construction permit 10 application, but ultimately, also, you're looking 11 forward towards the operating phase and making the 12 safety and environmental determinations that you will 13 need to make there.

14 I think it demonstrates to those skeptical, 15 or maybe those who feel that the NRC's approach and 16 regulations and guidance indicates a very linear and 17 rigid approach to licensing new and novel things. I 18 think both of those licensing activities demonstrated 19 significant ability to take a regulatory framework, 20 existing guidance, maybe complemented by some new 21 Interim Staff Guidance and take that and kind of wrap 22 it around the thing that's in front of you and say what 23 are the relevant and appropriate parts, and how do we 24 do that? And, often, you haven't taken years and years 25 worth of trying to develop the little bits that you need NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

73 1 to augment support.

2 Mr. Dean did mention that the Staff has been 3 preparing itself for a medical isotope application, but 4 the truth of the matter is, it could have taken a lot 5 of different forms. There's -- it could have been vastly 6 different, so what the Staff needed to have in place is 7 something that they could innovate and adapt, and tailor 8 to the thing in front of it. And I think, at least to 9 this stage of the process, and there are quite a few 10 issues, might get a little tricker in the operating 11 license phase because you've got to come to finality on 12 some complex issues. But that being said, the reason I 13 asked the Applicant in the Overview Panel about getting 14 some calibration on their view of regulatory 15 uncertainty is that when you're inside NRC, you often 16 walk around -- we walk around with greater familiarity, 17 perhaps, with the regulatory system, but maybe as a 18 result, a greater confidence in the ability to on our 19 feet do adaptation and innovation, and tailor that 20 particular regulatory framework to whatever is 21 presented to us for review and approval. And I think that 22 we've done that here.

23 So, having asked the Applicant how did this 24 adaptive process work from their standpoint, I think I 25 got a fairly positive response on that. How would the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

74 1 Staff answer that same question? Do you think that this 2 taking the existing regulatory framework guidance and 3 then adapting it, determining relevance of various 4 provisions within the framework, do you think that that 5 worked well to this stage, and is your confidence high 6 that that will continue through the remainder of the 7 review? Again, where you will be required to meet the 8 higher bar of coming to closure and finality on some open 9 issues that right now you can, in essence, to use a bad 10 word, punt those off to the operating license stage.

11 MR. DEAN: So, thank you for the remarks, 12 Commissioner. And I would agree with you, I think the 13 Staff has shown a high degree of flexibility and agility 14 in terms of how they have managed this review activity.

15 I think one of the important things for us, 16 and maybe Mirela can add something to this, is having 17 a sense of commitment on the part of the Applicant, so 18 that it was worthwhile to invest what we needed to do 19 in order to be at the stage that we're at to be able to 20 conduct the review. I think having some predictability 21 and confidence in that certainly helps us move forward 22 in a way that would allow us to apply all the resources 23 that we did. For example, to develop the ISG on the 24 aqueous homogenous reactor, I think was an important 25 development given the fact that we had confidence that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

75 1 there would be something coming forward from SHINE.

2 Mirela, do you have anything to add?

3 MS. GAVRILAS: Yes. I can add to that, and 4 I certainly agree what Bill said, that having the 5 interactions with SHINE throughout the process through 6 public meeting was very helpful. But getting back to 7 your original statement, indeed, the Staff does have 8 some confidence in the regulatory framework, and that 9 starts with we know that Part 50 is applicable to 10 irradiation facilities and to production facilities. We 11 know that the irradiation facilities, while they're 12 indeed novel to us, they look like our research 13 reactors, and we have experience with a spectrum of 14 research reactors that exhibit a lot of variability. We 15 have experience with -- I think just before this meeting 16 I was told 12 homogeneous aqueous research reactors, so 17 even there we have the experience necessary.

18 On the side of the production facility, we 19 have experience with Cintichem. Granted, that was under 20 Part 70, but we have the West Valley facility that was 21 actually licensed under Part 50. So, what the Staff did 22 is, we took the guidance that we had for these -- for 23 research and test reactor, the NUREG-1537 which is our 24 Standard Review Plan, augmented it with ISG that 25 captured liquid homogeneous reactors, and the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

76 1 production facilities and came up with a framework that 2 was suitable for SHINE.

3 COMMISSIONER SVINICKI: To build on that, 4 and this is my final question. Maybe this will be a 5 little tricky, so bear with me. Would the Staff assert 6 that the decisions that you've made to this point on 7 which portions and provisions within those portions of 8 our regulations are relevant to your review of this 9 technology on the safety side? Are those determinations 10 final, or subject to change? I guess what I'm asking is, 11 as you move towards closure in areas that you or the ACRS 12 have suggested bear additional work, criticality comes 13 to mind, other things where we have to adapt the 14 framework to the highly novel aspects of what we're 15 looking at and make a final safety determination. Do you 16 think you might determine that some section of the CFR 17 that you previously just weren't even engaging with the 18 Applicant on, you might suddenly go, you know, we didn't 19 really look there earlier, but based on the path that 20 this technical issue is taking, we now think that some 21 new provision of the regulation, you're going to have 22 to demonstrate that you meet some requirement there. Do 23 you think that that's likely or unlikely?

24 MS. GAVRILAS: I can try to answer that, and 25 maybe I'll need help on that. So, for the construction NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

77 1 permit we feel we're done, so basically there's nothing 2 that is needed. Looking forward to the operating 3 license, that's going to be our first priority, to look 4 at the regulations and see what, if anything, will need 5 to be adapted, be it by rulemaking, by order, licensing 6 conditions. We're going to think what's best for the 7 framework to be able to accommodate the operating 8 license review. And we already know that there are some 9 things that impact moly production facilities. For 10 example, the work on material characterization under 11 74, the rulemaking there is going to be relevant to moly 12 producers. There's security work under Part 73 that's 13 going to be relevant to them. We know that we'll need 14 to look closely at operator licensing because operators 15 might be needed not just for the utilization facility, 16 but also for the production facility, so we'll need to 17 scrutinize the regulation. So, we know we have some work 18 to do going forward.

19 As far as your question for the technology, 20 we haven't necessarily seen something in the regulation 21 that might need to be changed. It's more the 22 administrative procedural, not the technology itself 23 that is worrying us right now going forward.

24 COMMISSIONER SVINICKI: I need to ask a 25 follow-up based on that answer. Thank you for that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

78 1 answer.

2 If we look at the broad purposes of why an 3 agency such as ours reviews and issues a construction 4 permit, there is an element of wanting to identify 5 issues so that irreversible or very difficult to reverse 6 decisions are not made in the construction of the 7 facility; that, you know, you want some sense of, if 8 constructed in accordance with the construction permit 9 that we would issue, there would be high confidence that 10 if other issues are resolved you could operate that 11 facility at some point without needing to chip out a 12 4-foot thick concrete wall and make fundamental 13 changes. So, what is the Staff's level of confidence in 14 terms of the identification of relevant regulations 15 that you just described in your previous answer? Do you 16 think that that lends additional uncertainty going 17 forward to the probability of successful issuance of an 18 operating license in terms of physical rework of what 19 it is that they're going to construct? I know the 20 potential always exists. I'm not asking you if it's 21 zero. I'm asking you, you know, do you have like at least 22 a reasonable sense of confidence that you've identified 23 issues that have the potential for causing substantial 24 rework?

25 MS. GAVRILAS: So, perhaps what would help NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

79 1 is an example on where we set the bar for what's 2 sufficient for construction permit, as opposed to what 3 the expectation is for an operating license. And the bar 4 was, we heard SHINE speak earlier about hydrogen 5 control. So, hydrogen control is a perfect example, 6 because the physics. In other words, what the 7 concentrations are where deflagration becomes a concern 8 are known. The production rate of hydrogen is known. Our 9 models, we have well established uncertainties in those 10 models. We can bound them.

11 Furthermore, what's also known is 12 mitigation technology for that. For example, passive 13 autocatalytic recombiners, I think SHINE mentioned 14 those, igniters. There's technology to mitigate the 15 broad range of hydrogen production, so we know that. So, 16 the Staff has confidence that going forward that aspect 17 given where the state-of-the-art is in terms of both 18 knowledge and technology, and SHINE's responses to us 19 on what they intend to use, we have confidence that the 20 outstanding technical issues have a reasonable chance 21 of being addressed.

22 COMMISSIONER SVINICKI: Okay. So based on 23 that, is it fair to characterize that the Staff at this 24 stage has not recommended anything in terms of going 25 forward with the construction permit that it would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

80 1 identify as fundamentally unlicensable or unlikely to 2 be able to be operated or licensed at the operating 3 license stage?

4 MS. GAVRILAS: That's fair.

5 COMMISSIONER SVINICKI: Okay, thank you.

6 Thank you, Mr. Chairman.

7 CHAIRMAN BURNS: Thank you, Commissioner.

8 Commissioner Ostendorff.

9 COMMISSIONER OSTENDORFF: Thank you, 10 Chairman. Thank you all for your briefs today, and for 11 the work of you and your teams. It's important work.

12 I want to maybe, Mirela, pick up a little 13 bit with where Commissioner Svinicki was probing with 14 you. From your Slide 8 where you said the Staff used 15 existing guidance -- in the discussions with 16 Commissioner Svinicki and the exchange during her Q &

17 A -- I just want to make sure I understand one thing.

18 I think it is that you did not -- you and your team did 19 not experience any challenges working within our 20 existing regulations with our existing guidance as far 21 as being able to, I'll say, on the fly adapt where 22 judgment would lead one to say this is a reasonable way 23 of handling a particular design issue.

24 MS. GAVRILAS: No, the challenges as I -- in 25 my earlier answer, the challenge is where the bar for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

81 1 construction permit needs to be set relative to what our 2 expectations are in the final design. That was where the 3 Staff needed to exercise its technical judgment. We 4 haven't had areas where we needed to -- where we had 5 significant gaps that we needed to address, if I 6 understood your question correctly. If I didn't --

7 COMMISSIONER OSTENDORFF: Let me rephrase 8 it because I'm not sure -- I may not have asked it as 9 clearly as I should have.

10 Were there flaws or gaps in the existing NRC 11 regulations or guidance that prevented your team from 12 doing their work on the construction permit?

13 MS. GAVRILAS: There was one issue that we 14 had to address, specifically the fact that the 15 irradiation facility was not covered under Part 50 16 because they're subcritical and the definition for 17 irradiation facility --

18 COMMISSIONER OSTENDORFF: I understand. The 19 Commission got involved in that here.

20 MS. GAVRILAS: Yes, that's the only flaw 21 that we found.

22 COMMISSIONER OSTENDORFF: Okay. And you 23 felt like -- working within the existing guidance 24 documents that there was sufficient flexibility for the 25 Staff to be able to exercise reasonable judgment as to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

82 1 how to apply certain sections?

2 MS. GAVRILAS: Yes. And that might be aided 3 by the fact that the existing guidance that we relied 4 upon was primarily NUREG-1537, which is designed for 5 research reactors which do exhibit a fair amount of --

6 COMMISSIONER OSTENDORFF: Okay.

7 MS. GAVRILAS: -- differences.

8 COMMISSIONER OSTENDORFF: Okay. I think 9 this is still a question for you, but others may want 10 to chime in here. The first session with the SHINE panel, 11 I asked a question that was addressed I think by Eric 12 about the use of prototypes by SHINE organization, the 13 reference to other existing reactors, and I think Eric 14 mentioned one from the Los Alamos National Laboratory.

15 Can you talk at a high level about how our Staff perhaps 16 used experience of these prototypes or other existing 17 technologies to consider the construction permit?

18 MS. GAVRILAS: I'm going to ask Steve Lynch 19 who was the Project Manager on SHINE to talk about 20 specifics.

21 CHAIRMAN BURNS: Okay. And, Mr. Lynch, 22 identify yourself for the record, and confirm that you 23 took the oath.

24 MR. LYNCH: Yes. My name is Steve Lynch. I 25 am the Project Manager for SHINE on the NRC Staff. And NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

83 1 yes, I did take the oath.

2 CHAIRMAN BURNS: Okay, proceed.

3 MR. LYNCH: Yes. As far as facilities most 4 we considered on the irradiation facility side were 5 existing research reactors and past experience with 6 aqueous homogeneous reactors. On the production 7 facility side we did look back to our licensing 8 experience with the Cintichem facility. We actually did 9 have on staff former employees from Cintichem that 10 helped inform the development of our guidance and the 11 beginning of our review.

12 COMMISSIONER OSTENDORFF: Can you talk 13 about, Steve, I think Eric had mentioned SHINE's own 14 prototype efforts. Can you talk about how you might have 15 looked at those, or considered those in your review?

16 MR. LYNCH: We have not looked extensively 17 at the prototypes. We have considered some of the papers 18 that have come out from the National Labs describing 19 their results. We will look more carefully at that at 20 the operating license stage.

21 COMMISSIONER OSTENDORFF: Okay, thank you.

22 Jane, I don't want you to go without a 23 question here.

24 MS. MARSHALL: Thank you, sir.

25 COMMISSIONER OSTENDORFF: I'll ask an NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

84 1 environmental review question. And, you know, I think 2 Mirela has mentioned -- my question is what is this 3 like, the environmental review, is this like a research 4 test reactor, or is it like in Marissa's bailiwick the 5 fuel cycle facility? What does the environmental review 6 look like? Is it a hybrid of these, or something else?

7 MS. MARSHALL: It's a hybrid. I guess we're 8 lucky in a sense. All of the environmental regulations 9 are in Part 51, so we didn't have to look beyond that.

10 And as part of the environmental review, we looked at 11 the connected actions so we didn't just look at 12 construction, we looked at operation, decommissioning, 13 traffic flow. So, in that sense it was much like any 14 other environmental impact statement that we would 15 prepare.

16 COMMISSIONER OSTENDORFF: Okay. Anybody 17 else on that? All right, thank you. Thank you all.

18 CHAIRMAN BURNS: Thank you, Commissioner.

19 Commissioner Baran.

20 COMMISSIONER BARAN: Thanks. Well, let me 21 start by thanking you and the rest of the Staff who 22 worked on this application for all the hard work that 23 went not only into preparing for today's hearing, but 24 also all the efforts in reviewing this unique 25 application.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

85 1 I wanted to follow-up on a couple of things 2 I asked about -- asked SHINE about on the first panel.

3 Going back to the ACRS letter and the seven topics that 4 they identified that should be further addressed in an 5 application for an operating license. We talked to SHINE 6 about that. They said those are going to be addressed 7 in their Corrective Action Program. Can you talk a 8 little bit about how the Staff intends to ensure that 9 those issues are addressed in the operating license 10 application?

11 MS. GAVRILAS: Some of the items that came 12 out of the ACRS discussions are actually captured in our 13 SER. They are among the items that we listed in Appendix 14 A. Perhaps it's not the complete list, but we'll make 15 sure that when operating review -- operating license 16 review time comes we will look at the entirety of the 17 items that were mentioned by the ACRS in their letter.

18 There were also commitments that SHINE made 19 explicitly to the ACRS, and those we also captured in 20 the SER in the same Appendix A on the two items that the 21 ACRS had engaged them on, that the Staff had not 22 previously had discussions with them. So, we fully 23 intend to follow-up on all the items raised by the ACRS.

24 COMMISSIONER BARAN: Okay. And just to 25 clarify then for the answers to the pre-hearing question NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

86 1 related to this, some but not all of these items the ACRS 2 identified were captured as commitments on Appendix A, 3 in Appendix A.

4 MS. GAVRILAS: I believe that is the case.

5 We'll check during the lunch break and we'll get back 6 to you at the end of the day, if we need to make a 7 correction on that.

8 COMMISSIONER BARAN: Okay, great. Thanks.

9 And as we've noted at various points, some 10 of the regulations, like the general design criteria, 11 don't apply to SHINE because it's not a reactor. But the 12 Staff considered these regulations when doing its 13 review, and the Applicant considered them in its design.

14 Can you describe that process in a little bit more 15 detail? Would the Staff ask RAIs on concepts from the 16 general design criteria, or were these used as a 17 reference for the technical reviewers? What role did 18 they play?

19 MS. GAVRILAS: So, there's the expectation 20 in 50.34 of providing principal design criteria as 21 unambiguous, so we want that. What SHINE did in their 22 application, they actually came and had crosswalk 23 tables of all the 55 GDCs, how they apply or not apply, 24 or adapt to the features of their facility. So, the Staff 25 scrutinized that and found it acceptable. And I will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

87 1 give an example for containment, GDC-16 deals with 2 containment. They have a confinement, but they adapted 3 the notion of controlled leakage that's intended in 4 GDC-16. So, in addition to the GDCs, they also have the 5 GDCs, as you mentioned, are designed for light water 6 power reactor.

7 They also have a production facility that 8 has unique features. There they proposed safety systems 9 and components that actually lend themselves to 10 additional criteria. I'll give an example, the 11 concentration of uranium in the solution. That will 12 become part of the design basis. That is part of their 13 design basis, and it's a design criteria for them.

14 COMMISSIONER BARAN: Thanks, that's 15 helpful.

16 Bill, I have one question I think is 17 probably for you. And that has to do with how we're going 18 to oversee and inspect the SHINE facility during 19 construction if a construction permit is issued. Our 20 current construction inspectors have inspected against 21 the more detailed information provided in an operating 22 license. How would we ensure that the inspectors are 23 prepared to inspect against a construction permit?

24 MR. DEAN: So, I'll start and there may be 25 some others who can augment, maybe some of our battalion NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

88 1 of witnesses might want to chime in here.

2 So, we'll be leveraging, obviously, the 3 construction inspection experience that we have in 4 Region II to support the construction activities.

5 Clearly, we'll need to develop a construction 6 inspection program much like we did for the Vogtle and 7 VC Summer units. So, we have a model there, obviously, 8 it's going to be scaled down, but I would expect that 9 what we would have would be a replica of a much smaller 10 scale as to what we've done with the construction of the 11 AP-1000s.

12 MS. GAVRILAS: Yes, and we had -- we've done 13 significant work in that direction. And, actually, our 14 Office of New Reactors worked with Region II and, of 15 course, with the rest of us, and there is inspection 16 procedures. And the lead on that was Carl Weber, one of 17 our witnesses, and he can talk about the substance of 18 that procedure.

19 CHAIRMAN BURNS: Okay. Identify yourself, 20 and confirm you've been put under oath.

21 MR. WEBER: My name is Carl Weber. I work for 22 the Office of New Reactors in the Construction 23 Inspection Branch. And I helped to develop the overall 24 inspection program for basically radioactive isotope 25 production. We didn't do a specific program just for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

89 1 SHINE, we made it fairly generic. And what we did was 2 we went back and looked at similar -- programs with 3 similarities. For example, we looked at the Watts Bar 4 program where they were inspecting to a construction 5 permit. We also looked at the mixed oxide facility, and 6 we looked at the Louisiana Energy Services programs. We 7 got a group of people together who had experience in this 8 area, had a working group. We got all their experience, 9 and we developed the program specifically for the 10 radioactive isotope production.

11 CHAIRMAN BURNS: Okay. And confirm you were 12 put under oath before.

13 MR. WEBER: Pardon me?

14 CHAIRMAN BURNS: You did take the oath 15 before?

16 MR. WEBER: Oh, yes. I'm sorry.

17 CHAIRMAN BURNS: Okay, thanks.

18 COMMISSIONER BARAN: Thank you very much.

19 CHAIRMAN BURNS: I appreciate the 20 exploration of the differences in terms of construction 21 permit versus operating license that my colleagues have 22 done so far. A couple of questions I had actually, you 23 know, potentially looking forward. In effect, what we 24 actually have is eight production facilities. Correct?

25 MR. DEAN: Well, there will be eight NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

90 1 individual licenses.

2 CHAIRMAN BURNS: Eight individual. Will 3 there be eight individual licenses --

4 MS. GAVRILAS: Utilization facility.

5 CHAIRMAN BURNS: -- or is this -- would 6 the intention to be combined into one operating license?

7 MS. GAVRILAS: It's eight utilization 8 facilities, the irradiation facilities. And we're 9 looking at that. So, for example, just recently we were 10 scanning 50.56 and we saw one construction permit, one 11 operating license, and then we gave some thought to 12 50.52, that you can have activities from -- that you 13 would license by themselves. You could have them all 14 under one license. But that's all our thinking, it's 15 preliminary. It will depend on what SHINE applies for, 16 and then we'll need to be more rigorous in our 17 considerations.

18 CHAIRMAN BURNS: Okay. And a couple of other 19 questions. And, again, because we're adapting this type 20 of facility to the Part 50 framework, but two others 21 -- so, in this term have you looked down the road as 22 well, we're looking at license -- because I heard 23 someone mention licensed operators. So, we think that's 24 something that would be required or of value as part of 25 this facility licensing?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

91 1 MS. GAVRILAS: SHINE has, I believe, said 2 that they will have operators for the irradiation -- for 3 the radioisotope production part of their facility, so 4 that we need to look into more detail what provisions 5 are in 50.55 for licensing operators, if there's any 6 need for it. So, again, this is exploratory. They're 7 just things that as we're reviewing the construction 8 permit application are coming to mind and we're jotting 9 them down that we need to explore them further for the 10 operating license.

11 CHAIRMAN BURNS: Okay. And I'll just put one 12 more on the plate there, because I saw in the -- I was 13 looking at the draft construction permit and it speaks 14 to the financial protection and indemnity requirements 15 which are under Price-Anderson Act. And, again, it's a 16 Part 50 facility, so I mean looking at the regulations, 17 confirm under Part 140, Part 50 facility has those 18 -- so, again, is that -- now, again, I take it the Staff 19 is looking at those requirements under Price-Anderson 20 to the extent that they would apply. Obviously, this is 21 not a large, you know, 1,300 megawatt or 1,000 megawatt 22 operating plant, so there are different provisions, but 23 I'm presuming that's also something you need to resolve 24 in the longer term for the operating license.

25 MS. GAVRILAS: I've noted your comment.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

92 1 CHAIRMAN BURNS: okay.

2 MS. GAVRILAS: We haven't so far.

3 CHAIRMAN BURNS: Okay. Because it is 4 mentioned in the draft construction permit which is what 5 highlighted it to me.

6 MS. GAVRILAS: Okay, then I'm probably 7 unaware of our discussions.

8 CHAIRMAN BURNS: Okay. One of the things, 9 also, in terms of one of the findings highlighted, one 10 of the findings was that the Applicant is technically 11 and financially qualified for purposes of the 12 construction permit. Can you give me a description of 13 what the Staff did with respect to looking at financial 14 qualifications for the construction permit?

15 MS. GAVRILAS: At a very high level, we 16 basically scrutinized the funds that they have from 17 private investors. We also know that they are funded by 18 the Department of Energy, and we found that to be 19 sufficient for the purpose of construction permit.

20 CHAIRMAN BURNS: Okay, thanks.

21 There is a distinction, I think, made on one 22 of the slides between conditions in -- I think it's on 23 Slide 9. The slide says, "In some cases permit 24 conditions are necessary. In other circumstances" 25 -- then the next bullet says, "Regulatory commitments NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

93 1 track items for resolution in the Final Safety Analysis 2 Report or FSAR."

3 Can the Staff give me a distinction, what 4 elevates itself to a condition versus a commitment that 5 somehow is tracked and how do you track those 6 commitments?

7 MS. BAILEY: The conditions in the 8 construction permit are really associated with the 9 criticality, radiological safety primarily for the 10 radioisotope production facility. Criticality safety, 11 that part of the facility is controlled primarily 12 through geometry and the configuration of design. As 13 SHINE mentioned earlier, the design is preliminary.

14 It's still under development, as well as the analysis 15 that goes with it. So, the permit conditions basically 16 allow the Staff to confirm as the design and the 17 evaluations of the design progress that it's being done 18 in accordance with the design criteria that's described 19 in the Preliminary Safety Analysis Report.

20 What the conditions really do is it gives 21 us the assurance that SHINE will be able to provide the 22 necessary design and technical information in the Final 23 Safety Analysis Report for us to complete our safety 24 evaluation. So part of that goes to Commissioner 25 Svinicki's question about mitigating or avoiding a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

94 1 rework of the facility once construction is well 2 underway or completed.

3 CHAIRMAN BURNS: Okay. My final question 4 relates to the -- stated by the Staff, the Staff used 5 NUREG-1537 which has guidelines for preparation and 6 review of applications related to non-power reactors.

7 And it has some Interim Staff Guidance, there's some 8 Interim Staff Guidance that was used, which states it 9 was prepared for evolving technologies that were not 10 fully developed and demonstrated at the time of 11 publication. What has been your experience with using 12 this Interim Staff Guidance? What do you think you've 13 learned from using it? Is it doing what you hoped it 14 would do?

15 MS. GAVRILAS: It is doing what we hoped it 16 would do. It met our purposes just fine for the 17 construction permit, and we anticipate that it will 18 continue to do so for the operating license. We found 19 one fundamental problem with the guidance as we 20 developed it, and that had to do, we thought that the 21 irradiation facility was going to be able to be reviewed 22 as part of the production facility. That was not the case 23 for SHINE, for example. But other than that, the Interim 24 Staff Guidance works, and we anticipated incorporating 25 it into NUREG-1537 at the next revision of the document.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

95 1 CHAIRMAN BURNS: Okay. And the reason I want 2 to make sure I understand; the two parts of the facility 3 could not be -- I'm trying -- you said they could not 4 be reviewed?

5 MS. GAVRILAS: Yes, we initially --

6 CHAIRMAN BURNS: Explain that.

7 MS. GAVRILAS: I'm going to have to ask for 8 help if this is not enough. But we initially thought that 9 the irradiation facility and the production facility 10 can be treated as one entity. And then when we saw the 11 SHINE application and we started giving more thought, 12 we realized that they're actually distinct and they 13 deserve to be -- they need to be examined separately.

14 CHAIRMAN BURNS: But examined separately in 15 what sense, that the regulatory footprint is different?

16 Again, I think of a large power reactor that has a number 17 -- it has a reactor, it has a number of other buildings 18 that may support it. So, help me along here.

19 MR. DEAN: Can I -- let me just --

20 MS. GAVRILAS: Yes.

21 MR. DEAN: At a high level, I think if you 22 looked at the irradiation facility, that's more like a 23 research and test reactor. Right? Whereas, the 24 radioisotope production facility really has a lot more 25 commonality with a fuel cycle facility.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

96 1 CHAIRMAN BURNS: Okay.

2 MR. DEAN: Chemical processes, so I think 3 that kind of was -- as we looked at the SHINE 4 application, we realized we probably need to treat them 5 sort of independently because of that. I don't know if, 6 Marissa, you have anything you want to add in that 7 regard?

8 MS. BAILEY: I think that's pretty close. I 9 think it's really in terms of what are the applicable 10 acceptance criteria for each type of the facility. So, 11 for example, for the radioisotope production facility 12 because it resembles a fuel cycle facility in terms of 13 processes and hazards, we determined that even though 14 it's licensed under Part 50, we could use the 15 performance objectives in Part 70 to make a 16 determination of acceptability for safety.

17 CHAIRMAN BURNS: Okay. But, ultimately, 18 this is all licensed ---

19 MS. BAILEY: Under Part 50.

20 CHAIRMAN BURNS: Under Part 50, and it's all 21 licensed -- there's not another licensing action going 22 on. I understand that the criteria are different. We've 23 sort of banged this into Part 50 for the subcritical 24 assemblies in those units, and you have this other part 25 which is more like something we -- that NMSS would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

97 1 typically license. But the whole thing is put together, 2 ultimately, under this license.

3 MS. GAVRILAS: That's right.

4 MS. BAILEY: Yes.

5 CHAIRMAN BURNS: Okay. All right, thank you.

6 Commissioner Svinicki.

7 COMMISSIONER SVINICKI: Just a follow-up.

8 In response to the Chairman's question on 9 Price-Anderson indemnification and the Staff's answer, 10 that engendered a very energetic sidebar between 11 counsel for the Staff. Catherine or Mitzi, was there 12 anything counsel for the Staff wanted to respond on 13 that, or is that just you were excited because when the 14 Chairman opens the CFR during the meeting, you know 15 something is going to happen. Right? Did you want to 16 provide any augmentation to the Staff's answer on that?

17 You could say no, it's fine. You don't have to. I'm not 18 saying explain yourselves. I'm just saying, did you want 19 to supplement their answer?

20 MS. YOUNG: Mitzi Young, counsel for the NRC 21 Staff. First of all, let me defend myself. We've been 22 animated through the whole hearing. Every time you ask 23 a question we're excited because many of the questions 24 you asked are questions we practiced with them in part, 25 so this has been exciting from a number of respects. But NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

98 1 in terms of Price-Anderson, that is part of the review.

2 I believe 140 talks about a certain power level for 3 reactors, and I think what SHINE did in their 4 application, and Steven Lynch is obviously more 5 conversant on this than myself. They looked at 6 comparable power thermal output to identify what level 7 of Price-Anderson protection they would need. To the 8 extent that they're not receiving Special Nuclear 9 Material to get a construction permit, that assurance 10 is not needed now, but it would be part of the operating 11 license review.

12 Steve, was there anything you wanted to 13 add?

14 MR. LYNCH: That's it.

15 MS. YOUNG: Thank you.

16 CHAIRMAN BURNS: All right, thanks very 17 much, Mitzi.

18 COMMISSIONER SVINICKI: Thank you.

19 CHAIRMAN BURNS: Thanks, Commissioner.

20 With that, we'll take a brief break and then 21 resume with Safety Panel 1. So, try to be back in your 22 seats in about five or six minutes.

23 (Whereupon, the proceedings went off the 24 record at 11:05 a.m., and went back on the record at 25 11:15 a.m.)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

99 1 CHAIRMAN BURNS: We'll call the hearing 2 back to order. In this next session we'll have Safety 3 Panel 1 and we'll hear first from the Applicant, SHINE.

4 We'll immediately follow that with the staff's 5 presentation for Safety Panel 1 and then follow with 6 Commissioner questions. And in general the topics will 7 cover the chapter 1 of the Safety Evaluation Report with 8 respect to the facility, and chapter 4, irradiation unit 9 and radioisotope production facility description to 10 address the licensing considerations for the 11 subcritical utilization facilities and production 12 facility.

13 So with that, we'll go to our first panel 14 from SHINE. Mr. Hennessy and Mr. Van Abel are here, 15 but, Ms. Kolb, I'll ask you to introduce yourself.

16 MS. KOLB: My name is Catherine Kolb. I'm 17 a supervisor in engineering for SHINE Medical 18 Technologies.

19 CHAIRMAN BURNS: Okay. Thanks very much.

20 And again, assume that the Commission is generally 21 familiar with the prehearing filings, and I remind you 22 you're under oath. And please proceed.

23 MR. VAN ABEL: All right. Good morning 24 again. In this presentation I'd like to give a brief 25 continuing discussion on the facility.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

100 1 If we'd go to the next slide, slide 2. Here 2 again is the overall facility process overview. We 3 went through this in some detail in the overview 4 discussion. I'm going to add a little additional 5 detail on the design requirements for these SSCs in this 6 presentation, but of course if we have any other 7 questions on the overall facility design, happy to 8 answer those as well.

9 Next slide, please. For the SHINE 10 facility certain SSCs are designated as safety-related 11 in our facility because they are relied upon to perform 12 safety functions either during normal operations or 13 during design-basis events. And those SSCs that are 14 required to perform safety functions are required to 15 perform those in the environmental conditions of normal 16 operation and any accidents in which they are required 17 to function. For those SSCs that have safety 18 significance, we design them, fabricate them and test 19 them commensurate with the criteria set forth in 20 ANSI/ANS-15.8, which are the quality assurance 21 requirements for research reactors. SHINE implements 22 that ANSI/ANS-15.8 standard through our Quality 23 Assurance Program description, or QAPD.

24 Next slide, please. On this slide we have 25 the safety-related definition that SHINE applies to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

101 1 design. This is a comprehensive definition that we've 2 modified from 10 CFR 50.2 and we've also included the 3 requirements from 10 CFR 70.61, the performance 4 requirements there as they're applicable to the 5 radioisotope production facility.

6 The SSCs that are safety-related are those 7 that are relied upon to meet any of the six criteria 8 listed here. The first three are modifications of 10 9 CFR 50.2 and include the integrity of the primary system 10 boundary, the capability to shut down our target 11 solution vessel and irradiation process and maintain it 12 shutdown, and the capability to prevent accident dose 13 consequences that would exceed 10 CFR 20.

14 And the last three are familiar to the fuel 15 cycle facility folks. These are to ensure that our 16 nuclear processes remain subcritical including the use 17 of an approved margin of subcriticality, to ensure that 18 chemical exposures from accidents are acceptable for 19 both the worker and the public, and that an intake of 20 30 milligrams or greater of soluble uranium does not 21 occur for personnel outside the owner-controlled area, 22 the OCA.

23 Next slide, please. For our SSCs we 24 require them to be designed to withstand external 25 events. Our outer building structure is designed to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

102 1 resist external events such as tornadoes, aircraft 2 impacts and other external events. And also the SSCs 3 within the building are required to withstand our 4 design-basis earthquake if they perform a 5 safety-related function or they're necessary to ensure 6 they do not degrade the performance of a safety-related 7 SSC.

8 We also apply a graded quality level to the 9 design of our SSCs. We have three quality levels as 10 described here. Quality Level 1 is applied to our 11 safety-related components SSCs, and that is the full 12 measure of our QAPD is applied to those SSCs. Also, we 13 apply Quality Level 2 to SSCs that could affect the 14 safety function of safety-related SSCs specifically to 15 support or protect the safety function of those SSCs.

16 And we apply graded quality to those components that's 17 commensurate with their importance to safety. And 18 Quality Level 3 is applied to those SSCs that don't meet 19 the definition of Quality Level 1 or 2.

20 Next slide, please. We also apply single 21 failure criterion to our systems. For safety systems 22 we ensure that there is sufficient redundancy and 23 independence such that a single failure of an active 24 component does not result in the loss of capability to 25 perform the safety function. And for accident analysis NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

103 1 we ensure that a single failure in conjunction with the 2 initiating event does not result in the loss of the 3 safety system's ability to perform the safety function.

4 So throughout our design process we use a robust 5 defense-in-depth approach to design, and we have a 6 strong preference in the design for passive and 7 engineered controls over administrative controls. And 8 that concludes my presentation.

9 CHAIRMAN BURNS: Okay. Thank you. And 10 I'll ask the staff witnesses to come forward, take their 11 seats at the table.

12 And I remind you that you're under oath and 13 start with the introduction of the witnesses. Start 14 with you, Mr. Lynch.

15 MR. LYNCH: My name is Steve Lynch. I'm 16 the project manager for SHINE Medical Technologies on 17 the NRC staff.

18 MR. ADAMS: My name is Al Adams. I'm the 19 Chief of Research and Test Reactor Licensing in NRR.

20 MS. ADAMS: Mary Adams. I'm an engineer 21 in the Division of Fuel Cycle Safety Safeguards and 22 Environmental Review in NMSS.

23 CHAIRMAN BURNS: Okay. Thank you.

24 Please proceed.

25 MR. ADAMS: Good morning. This panel will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

104 1 discuss the unique licensing considerations of the 2 SHINE utilization and production facilities. I will 3 discuss the general licensing considerations and a 4 review performed by the Advisory Committee on Reactor 5 Safeguards, the ACRS. Steve Lynch will discuss the 6 licensing of the irradiation units and Mary Adams will 7 discuss the licensing of the production facility.

8 Next slide, please. SHINE seeks to 9 construct non-power utilization facilities and a 10 production facility. Therefore, an initial 11 consideration was whether to license SHINE's proposed 12 facilities under Section 103 or Section 104 of the 13 Atomic Energy Act. While the hazards associated with 14 SHINE's facility are similar to non-power research 15 reactors which are licensed under Section 104 of the 16 Atomic Energy Act, SHINE's facility is intended to be 17 used for commercial purposes, not for conducting 18 research and development or medical therapy.

19 Therefore, while the licensing process would be similar 20 to a research reactor, SHINE's facility would be 21 licensed under Section 103 of the Atomic Energy Act.

22 Section 103 imposes additional procedures 23 on construction permit applications including an 24 independent review of the application by the ACRS and 25 a mandatory hearing, which we are having today.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

105 1 Because SHINE's facility is a subcritical system which 2 produces fission power, it introduces aspects of a 3 review typically done for non-power reactors. For 4 these areas the staff developed and used the Interim 5 Staff Guidance for NUREG-1537, which is a standard 6 review plan for non-power reactors.

7 Next slide, please. The staff presented 8 the results of its safety review at three ACRS 9 Subcommittee meetings and before the full ACRS. During 10 its review the ACRS identified two safety concerns that 11 could impact the operation of the SHINE facility if not 12 sufficiently addressed. These concerns were the 13 capability to lay up the facility and the facility's 14 ability to withstand potential aircraft impact.

15 SHINE and the staff provided additional 16 information to the ACRS in these areas. The ACRS 17 determined that sufficient information was provided 18 such that it could recommend the issuance of a 19 construction permit. This recommendation is reflected 20 in the ACRS letter dated October 15th, 2015, which is 21 in the staff's SER.

22 The ACRS letter also noticed several issues 23 that must be addressed at the operating license stage 24 including criticality control and margin. The staff 25 agrees that each item that the ACRS identified must be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

106 1 addressed at the operating license stage. And Mirela 2 was correct during her testimony that written comments 3 were not provided, or written commitments were not 4 provided by SHINE in all these areas, however, the staff 5 is aware of them and we determined that they're not 6 needed for the issuance of the construction permit, but 7 will be addressed at the operating license stage.

8 Next slide, please. Steve Lynch will now 9 discuss specific licensing considerations related to 10 the SHINE irradiation facility.

11 MR. LYNCH: Thanks, Al. SHINE's proposed 12 irradiation units presented unique licensing 13 considerations under 10 CFR Part 50, which has 14 traditionally been applied to the construction and 15 operation of nuclear reactors. However, unlike 16 nuclear reactors, SHINE's irradiation units are not 17 designed to go critical during operation. Therefore, 18 SHINE's irradiation units represent a new application 19 of technology.

20 Given their subcritical nature, the staff 21 considered whether it should review SHINE's irradiation 22 units under 10 CFR Part 70, which can be applied to 23 certain facilities that possess and use special nuclear 24 material. However, these facilities, generally 25 referred to as fuel cycle facilities, have the common NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

107 1 objective of avoiding criticality by a significant 2 margin under both normal operating and accident 3 conditions. In contrast, SHINE's minimal margin of 4 subcriticality is less than what has been previously 5 approved for other 10 CFR Part 70 licensees and more 6 closely resembles the operating state of a nuclear 7 reactor.

8 Because of this the staff determined that 9 it would be most appropriate to use the 10 CFR Part 50 10 regulations for utilization facilities to perform its 11 technical review of the irradiation units. Therefore, 12 the NRC issued a direct final rule that revised the 13 definition of utilization facility in 10 CFR 50.2 to add 14 SHINE's subcritical operating assemblies. If 15 licensed, SHINE's irradiation units would be the first 16 utilization facilities to operate in a minimally 17 subcritical range.

18 Next slide, please. Classifying SHINE's 19 irradiation units as utilization facilities allowed the 20 staff to conduct its review following the regulations 21 designed for technologies with similar radiological, 22 health and safety considerations. In particular, the 23 accelerator and neutron multiplier of each irradiation 24 unit achieve a fission rate with a thermal power level 25 comparable to that of other non-power reactors licensed NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

108 1 under 10 CFR Part 50. Because of their thermal power 2 levels the irradiation units share similar safety 3 considerations with other non-power reactors, 4 including provisions for the removal of fission heat 5 during operation, passive decay heat generation after 6 shutdown, fission gas 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 Staff 11 Guidance for aqueous homogeneous reactors to conduct 12 its review. Specific design areas of the staff's 13 review included SHINE's reactivity control mechanisms, 14 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.

24 The RPF also consists of several physical 25 and chemical processes that are similar to those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

109 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 Staff 8 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 analysis 14 guidance which include the criteria in 10 CFR 70.64. As 15 noted in the guidance, an application meeting these 16 baseline design criteria would be found acceptable by 17 the staff. SHINE's construction permit application 18 proposed these acceptable baseline design criteria for 19 the RPF. After reviewing the application, the staff 20 finds that SHINE's application met these baseline 21 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

110 1 conditions. In particular, the staff has proposed four 2 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 and 13 occupancy times within the RPF are consistent with as 14 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 begin 24 our questions. And we'll begin our questions for this 25 panel with Commissioner Ostendorff.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

111 1 COMMISSIONER OSTENDORFF: Thank you, 2 Chairman, and thank you all for your briefs. I do have 3 a question for the Applicant, and I'm going to your slide 4 6. And under the single failure criterion being 5 applied to safety systems, I just wanted to ask a 6 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 of the ability 9 to perform its function? Can you talk about how you 10 apply that concept to reliability of electrical power 11 as it affects instrumentation control or alarms?

12 MR. VAN ABEL: Yes, for instrumentation 13 control and electrical power we have very minimal 14 requirements for those for safety-related purposes.

15 And those that we do have are primarily for hydrogen 16 mitigation after shutdown and some instrumentation 17 control systems that monitor the system after shutdown.

18 And those are provided by an uninterruptible power 19 supply system that will be designed based on single 20 failure criterion to look at failure of components such 21 as a breaker supplying power to ensure that there's 22 redundant reliable means to supply that power to the 23 equipment requiring it.

24 COMMISSIONER OSTENDORFF: With respect to 25 your criticality alarm system, does that have redundant NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

112 1 power supplies? Or that may not have been designed yet; 2 I don't know, but where does that fall with respect to 3 this philosophy of redundancy?

4 MR. HENNESSY: It would be. It's not 5 designed yet, but it's a safety-related system, so --

6 COMMISSIONER OSTENDORFF: Okay.

7 MR. HENNESSY: -- these same design 8 principles would apply.

9 COMMISSIONER OSTENDORFF: Okay. Thank 10 you.

11 Let me shift back to the staff now. Mary, 12 I wanted to ask you a question on your slide, I think 13 7 -- excuse me, 8. There's a reference to criticality 14 events not being credible. Can I just ask you to 15 elaborate on that just a little bit about what's the 16 basis for that statement?

17 MS. ADAMS: 10 CFR 70.61, which formed the 18 basis of the Interim Staff Guidance, states as an 19 acceptance criterion that all processes need to be 20 subcritical under normal and credible abnormal 21 operating conditions. And so, what exactly does 22 "credible abnormal" mean? And we ask our applicants to 23 very carefully define what they mean by credible and not 24 credible with respect to criticality safety.

25 COMMISSIONER OSTENDORFF: So with respect NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

113 1 to the design aspects of what's been presented to the 2 NRC staff how is that achieved?

3 MS. ADAMS: I want to call on --

4 COMMISSIONER OSTENDORFF: Or as a 5 condition of not having a credible criticality event.

6 MS. ADAMS: I'd like to call on Dr. Chris 7 Tripp to answer that question.

8 CHAIRMAN BURNS: Okay. And please 9 identify yourself for the record and confirm that you 10 took the oath earlier.

11 DR. TRIPP: Okay. I'm Christopher Tripp.

12 I'm the criticality safety reviewer in FCSS for the RPF, 13 and, yes, I did take the oath.

14 CHAIRMAN BURNS: Okay. Please proceed.

15 DR. TRIPP: Okay. With regard to 16 credibility, when SHINE originally provided their PSAR 17 section on criticality safety, they said that they were 18 going to design it so that criticality would be not 19 credible and then any controls so identified would be 20 identified as SSCs. This was meant to meet the 21 performance requirements.

22 Some of those criteria that were mentioned 23 were from the performance requirements of Part 70. And 24 the usual approach on the Part 70 side has been that we 25 required criticality and other high-consequence events NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

114 1 to be highly unlikely and then those items would be 2 identified as items relied on for safety under the Part 3 70 framework. So there seemed to be some confusion as 4 to what the exact -- how that would be applied to the 5 RPF.

6 And in the fuel cycle area we have had a lot 7 of discussions in the existing fuel facilities 8 concerning the basis for deciding events are credible 9 or not credible, and when you have to make that 10 demonstration and what you're allowed to take credit 11 for. So this has been an ongoing issue with the 12 industry. Therefore, we proposed these conditions to 13 give us additional confidence that they understood what 14 they were committing to to be able to apply that 15 acceptably in the design.

16 COMMISSIONER OSTENDORFF: Okay. Well, 17 are you expecting this condition to lead to articulation 18 of specific engineered features as far as volume control 19 on solution or can you be a little more specific as to 20 how this might play out in the facility's actual design?

21 DR. TRIPP: Yes. So the first step in 22 applying the criteria -- the main criteria for 23 criticality is they be subcritical under normal and 24 credible abnormal conditions. So the first step of 25 that is identifying what are the credible criticality NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

115 1 hazards and then designing the different safety 2 barriers against that. So it's at that first step of 3 deciding what is credible and what hazards have to be 4 protected against that we would want to make sure that 5 they had an acceptable way of doing that.

6 COMMISSIONER OSTENDORFF: So what are some 7 examples? I'm trying to get to a more practical 8 engineered feature discussion here. What are some 9 examples of how the licensee might satisfy that 10 condition?

11 DR. TRIPP: Well, there are three criteria 12 for what they consider credible: One is an external 13 event with frequency of 10 to the minus 6th based on the 14 fuel cycle guidance that was incorporated into the ISG.

15 The other is basically a string of independent events 16 that together collectively make up a set of unlikely 17 events that would have to occur that we wouldn't think 18 are credible. And the third is that they'd be 19 physically impossible.

20 COMMISSIONER OSTENDORFF: So is there an 21 example of the physically impossible that you can offer 22 for us?

23 DR. TRIPP: Well, we don't have specific 24 examples that apply directly to SHINE because we haven't 25 reviewed specific design features at this point. We've NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

116 1 only reviewed the design criteria. But in the other 2 fuel cycle arrangement -- for example, most of the 3 processing, the solution processing, which is similar 4 to what they have in other parts of the fuel facility, 5 are in safe geometry containers, safe geometry columns 6 and so forth. And one of the things you have to guard 7 against is backflow. So a lot of the time they're 8 protected against with say a siphon break or an overflow 9 or something of that nature so that -- liquid doesn't 10 flow against gravity. That would be considered 11 incredible. But it's only based on having that passive 12 feature in the design.

13 COMMISSIONER OSTENDORFF: Okay. That 14 example was very helpful. Thank you. Thank you, 15 Chairman.

16 CHAIRMAN BURNS: Thank you. Commissioner 17 Baran?

18 COMMISSIONER BARAN: Thanks. I want to 19 ask about slide 4 of SHINE's presentation which relates 20 to the definition of structures, systems and 21 components. The proposed definition, SSC definition 22 states in bullet 3 that SSCs assure the capability to 23 prevent or mitigate the consequences of accidents which 24 could result in potential exposures comparable to Part 25 20. The definition also states in bullet 6 that SSCs NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

117 1 assure that an intake of 30 milligrams or greater of 2 uranium in soluble form by any individual located 3 outside the owner control area does not occur.

4 The NRC's occupational dose requirements 5 in Part 20 state that the licensee shall limit the 6 soluble uranium intake by an individual to 10 milligrams 7 in a week in consideration of chemical toxicity. Can 8 SHINE discuss the basis for setting the SSC definition 9 at no more than 30 milligrams? How does that line up 10 with -- how is that reconciled with the Part 20 11 requirements?

12 MR. HENNESSY: The definition in Part 6, or 13 the term in Part 6 was derived from the 10 CFR 70.61 14 performance requirements, and that's what it reflects 15 back as.

16 As far as the 10 CFR 20 requirements, our 17 concern, they would still be applicable and we would 18 still apply that under No. 3. So we'll have to look at 19 your --

20 COMMISSIONER BARAN: Okay.

21 MR. HENNESSY: -- comment and think about 22 that.

23 COMMISSIONER BARAN: Do you know if 24 there's a time frame that applies to the 30-milligram 25 level?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

118 1 MR. HENNESSY: I'm not aware of one.

2 COMMISSIONER BARAN: Okay.

3 MR. HENNESSY: Eric, do you have any idea?

4 MR. VAN ABEL: It's for an accident 5 evaluation for --

6 COMMISSIONER BARAN: Okay.

7 MR. VAN ABEL: -- normal operations.

8 COMMISSIONER BARAN: So that's basically 9 total intake --

10 MR. VAN ABEL: Yes. Right.

11 COMMISSIONER BARAN: -- over whatever 12 period of time?

13 MR. VAN ABEL: That's correct.

14 COMMISSIONER BARAN: Okay. And then the 15 Part 20 standards have a limit of 10 milligrams per week.

16 Maybe I'll ask the staff to comment on this. How did 17 you all conclude that the proposed definition element 18 of an intake of 30 milligrams of uranium in soluble form 19 is an acceptable limit for the definition?

20 MS. ADAMS: I'd like to call on Greg 21 Chapman, the health physicist who reviewed the RPF.

22 MR. CHAPMAN: Greg Chapman, NMSS, health 23 physicist. I did take the oath.

24 CHAIRMAN BURNS: Great.

25 MR. CHAPMAN: With regards to the 10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

119 1 milligram or 30-milligrams, 30 milligrams is typically 2 the criteria that were replaced with the public for Part 3 70-type review. And we typically look at it as an acute 4 exposure over 24 hours1 days <br />0.143 weeks <br />0.0329 months <br />. So 10 milligrams for accident 5 exposure as well as 30 milligrams, I would apply the same 6 criteria, 24 hours1 days <br />0.143 weeks <br />0.0329 months <br />.

7 COMMISSIONER BARAN: Okay. And so under 8 this definition the potential intake from a member of 9 the public of 30 milligrams looks to be about 3 times 10 higher than the limit you would have over the course of 11 a week for someone working at the facility, is that 12 right?

13 MR. CHAPMAN: That's correct.

14 COMMISSIONER BARAN: Okay. And can you 15 tell us a little bit more about how when you evaluated 16 that that that seemed like an acceptable result?

17 MR. CHAPMAN: I'd have to get back with you 18 on that. I can't recall at the moment.

19 COMMISSIONER BARAN: I don't know if this 20 is a matter of a temporal issue here or there's something 21 else at play, but maybe you could get back to us on that.

22 Al or Steve, in prehearing question 15 we 23 asked whether the application specified how many 24 irradiation units a single operator could control, and 25 both the staff and SHINE stated that that would be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

120 1 addressed during the operating license application.

2 Can you talk a little bit about how the number of 3 operators relates to the size of the control room and 4 whether that's an issue that needs to be resolved now 5 at the construction permit stage?

6 MR. LYNCH: So that is something that we 7 haven't looked extensively at the construction permit 8 stage. Some of the considerations: More than just the 9 size of the control room, we're looking at the layout 10 of the control room, especially if there will be 11 operators looking at the production facility versus the 12 irradiation facility, and we need to get a better 13 understanding of how the controls will be laid out and 14 to make a determination on the number of operators that 15 are needed.

16 COMMISSIONER BARAN: Okay. So in terms of 17 getting at the issue that Commissioner Svinicki raised 18 about not wanting a situation where someone has a 19 construction permit, they build something out, we look 20 at it later and say, no, no, that's not going to work 21 and people have to kind of redo things, from the staff's 22 point of view is the number of operators, total number 23 of operators that would be working in the control 24 room -- is that going to be relevant to the layout, the 25 construction of that control room in a way that makes NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

121 1 it something that we should address now at the 2 construction permit stage, or, no, it's just an 3 operating license issue?

4 MR. LYNCH: So based on the information 5 SHINE has provided in their PSAR and discussions we had 6 with the ACRS on this issue, the staff hasn't noted 7 anything that would prevent the facility from being able 8 to operate.

9 COMMISSIONER BARAN: Okay. I want to also 10 ask about, follow up on prehearing question 11 related 11 to the probabilities used for aircraft accidents and 12 external design-basis accidents. I'm interested in 13 how the staff selected the size of the aircrafts for this 14 hazard analysis. Did the staff look only at the types 15 of aircraft that could land or take off from the nearest 16 airport that the facility intends to be using quite a 17 bit, or did you also assess larger aircraft that could 18 potentially pass through the air space near the proposed 19 facility?

20 MR. LYNCH: I think the best person to 21 respond to this question would be Steve Marschke.

22 CHAIRMAN BURNS: Again, Mr. Marschke, just 23 state your name for the record and your position and 24 confirm that you were put under oath.

25 MR. MARSCHKE: My name is Steve Marschke.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

122 1 I work with Sanford Cohen & Associates, and we're 2 consulting staff on the chapter 2 review. And, yes, I 3 did take the oath.

4 When we looked at the aircraft accident 5 probability analysis, we looked at really what SHINE has 6 done. And they looked at all the accidents which 7 are -- or all the aircraft which land and take off at 8 that airport, the Southern Wisconsin Regional Airport.

9 And they have the statistics from the FAA which 10 identifies the types of aircraft, military aircraft.

11 And most of them are air carriers and commuter aircraft 12 and those types of aircraft. They've been grouped into 13 those categories. They also looked at air corridors, 14 which transverse the area. And so, we kind of just -- we 15 reviewed what the SHINE facility has done.

16 COMMISSIONER BARAN: In terms of those air 17 corridors -- so this is a relatively small regional 18 airport. I assume the planes as you described are 19 relatively small that will be taking off and landing 20 from there. Are the air corridors that SHINE examined 21 and that you all looked at -- are those corridors that 22 involve much larger aircraft? When we talk about 23 planes going to like O'Hare Airport in Chicago or --

24 MR. MARSCHKE: The air corridor is -- the 25 probabilities associated with the traffic in the air NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

123 1 corridors were very low. And so, the air corridors 2 themselves fell below the probability cutoffs. And 3 it's really the aircraft which are utilizing the 4 regional airport which challenge the probability 5 cutoffs.

6 COMMISSIONER BARAN: Okay. So any larger 7 aircraft beyond what would land or take off at the 8 regional airport didn't kind of pass the probabilities 9 level to be examined. Is that correct?

10 MR. MARSCHKE: That's correct.

11 COMMISSIONER BARAN: Okay. Thank you.

12 And just one more question. Prehearing question 35 13 focused on the assessment of accidental explosions at 14 the SHINE facility. SHINE's response to the question 15 stated that they analyzed the potential impact of 16 natural gas pipelines on the facility. Can the staff 17 or SHINE, whoever makes sense; maybe the staff, Al or 18 Steve -- can you clarify which natural gas pipelines are 19 in the area of the proposed facility and how the staff 20 determined that they were not hazards?

21 MR. LYNCH: I think we're going to ask to 22 get some help here as well.

23 COMMISSIONER BARAN: You're back.

24 MR. MARSCHKE: I'm back.

25 (Laughter)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

124 1 MR. MARSCHKE: Can't get enough.

2 CHAIRMAN BURNS: Still under oath.

3 MR. MARSCHKE: Yes. Well, my answer is 4 going to be I'm going to have to get back to you on that, 5 because in preparing for today's meeting I wasn't really 6 looking at the pipelines. I wasn't anticipating -- I 7 was anticipating the aircraft questions, but not the 8 pipeline questions, and so I haven't briefed myself.

9 Maybe after lunch I can look at my notes and get back 10 in touch.

11 COMMISSIONER BARAN: Is this something 12 that the staff has looked at?

13 MR. MARSCHKE: No, we have looked at it, 14 but I just haven't looked at it recently and I don't want 15 to misinform the Commissioners.

16 COMMISSIONER BARAN: Okay.

17 CHAIRMAN BURNS: What we can do, we can 18 either hold to the end of the day if the staff wishes 19 to provide a supplemental answer, or we'll proceed with 20 putting it for perhaps a question following up.

21 COMMISSIONER BARAN: That makes sense.

22 Thank you, Mr. Chairman.

23 CHAIRMAN BURNS: Thanks, Commissioner.

24 COMMISSIONER BARAN: That's all my 25 questions. Thank you.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

125 1 CHAIRMAN BURNS: A couple things: Just I 2 guess to -- given some of my colleagues' questions 3 regarding the facility and all, can -- probably the 4 Applicant's the best idea. In looking at some of the 5 slides -- it's actually from the first -- the overview 6 presentation, can you give me an idea of the footprint, 7 the area or size of the facility itself? Because I've 8 got a picture, but it could be a doll house or a large 9 enrichment facility. So just give me an idea of the 10 footprint.

11 MR. HENNESSY: The main building size is 12 around 55,000 square feet --

13 CHAIRMAN BURNS: Okay.

14 MR. HENNESSY: -- which is a little over an 15 acre in size. The whole site is 91 acres, so --

16 CHAIRMAN BURNS: Yes.

17 MR. HENNESSY: -- we're a dot in the middle 18 of a large area.

19 CHAIRMAN BURNS: Okay. And so 20 location-wise within that 91 acres are you sort of in 21 the middle of it? Is that the intention?

22 MR. HENNESSY: Yes.

23 CHAIRMAN BURNS: So you have a large -- in 24 fact what we'd call in a reactor facility the 25 owner-controlled area in that case?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

126 1 MR. HENNESSY: That's correct.

2 CHAIRMAN BURNS: Okay. What is 3 this -- and I'm looking and I just don't recall -- what 4 is the seismic design-basis for the facility? Either 5 the Applicant or the staff can respond to that.

6 MS. KOLB: The staff can -- or I mean SHINE 7 can respond to that. I'd like to ask Alan Hull to take 8 that.

9 CHAIRMAN BURNS: Okay.

10 MR. HULL: Good morning. My name is Alan 11 Hull. I work for Golder Associates. I'm a seismic 12 hazard specialist.

13 CHAIRMAN BURNS: And you were put under 14 oath earlier?

15 MR. HULL: I was put under oath, yes, and 16 I took it.

17 CHAIRMAN BURNS: Please proceed.

18 MR. HULL: So for the design-basis 19 earthquake you notice there were three stages. I can 20 comment only on the analysis that was done to come up 21 with the ground shaking, and the structural engineer for 22 SHINE will be able to talk about how that flowed on into 23 the actual design of the facilities.

24 From our analysis we found that this part 25 of the United States is one of the lowest seismic hazards NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

127 1 in the area. In fact, there were only about 58 2 earthquakes within 200 miles in the last 200 or so years.

3 So when we looked at where the seismic design should come 4 from, we analyzed all those facilities as we might have 5 done for a power reactor.

6 CHAIRMAN BURNS: Yes.

7 MR. HULL: And by looking at the United 8 States geological survey seismic hazard model for the 9 United States we determined that a magnitude 5.8 10 earthquake is the likely design-basis or maximum 11 earthquake for this facility. The standard is about 12 0.2 g.

13 CHAIRMAN BURNS: Okay.

14 MR. HULL: That's 20 percent of the force 15 of gravity. We looked at that seismic hazard model for 16 the United States and found that has a return period of 17 about 20,000 years.

18 CHAIRMAN BURNS: Okay. And my 19 recollection from a long time ago dealing with some 20 other facilities is that 0.2 g -- the shaking force is 21 more or less equivalent to what I think a number of the 22 other reactors are designed for.

23 MR. HULL: That's my understanding. And 24 my understanding also -- and again, a structural 25 engineer from Sargent & Lundy could provide more detail.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

128 1 My understanding is that that value of 0.2 g is being 2 used for the structural design of the Quality 1 3 facilities.

4 CHAIRMAN BURNS: Okay. All right.

5 Thanks very much.

6 The other thing is I'd ask the Applicant; 7 and the staff can certainly add, is what analysis of 8 flooding hazards were done with respect to the site?

9 And again, I know nothing of the site, so it may be a 10 silly question and it may not be. But, please.

11 MS. KOLB: We did do flooding hazards 12 analysis. We looked at the probable maximum 13 precipitation events and the probable maximum flood.

14 The Rock River is about two miles from the site, but the 15 difference in elevation from the site elevation to the 16 Rock River, even in the probable maximum flood 17 situation, is still about 50 feet below the elevation 18 of the site. So that was determined to not pose a hazard 19 to the facility.

20 For the probable maximum precipitation 21 based on the area of the site, it comes up to about the 22 elevation of the site in the probable maximum 23 precipitation event, which we did analyze, but it does 24 not flood the structure. And if you'd like more detail, 25 we have a geotechnical engineer from Golder that could NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

129 1 answer, provide more detail.

2 CHAIRMAN BURNS: I think that's good for 3 now. Thank you.

4 The final question I'll have here is with 5 respect to any analyses that were done with respect to 6 control or mitigation of release of tritium from the 7 facility since it does use tritium, and that's been an 8 issue, and it may be again. Because of the design it 9 may not be as much of an issue for you all, but it has 10 been an issue at some nuclear power plant sites.

11 MR. VAN ABEL: Yes. Yes, as I mentioned 12 before, we have a tritium purification system and the 13 accelerators themselves use a tritium gas target.

14 There are number of features there to control and 15 prevent the release of tritium to the environment. One 16 of the primary ones is that second confinement barrier, 17 the double-walled pipe around the tritium piping. And 18 the tritium processing equipment is in glove boxes, and 19 those glove boxes are continuous scrubbing of the 20 atmosphere to remove tritium from the atmosphere, the 21 glove box and maintain that concentration extremely 22 low. And any discharges from the glove box are 23 monitored and ensured that they're below acceptable 24 limits.

25 CHAIRMAN BURNS: Okay. Thank you very NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

130 1 much. Thank you. Commissioner Svinicki?

2 COMMISSIONER SVINICKI: Thank you all for 3 your presentations. I just have one question. It can 4 be for either the staff or the Applicant and which 5 subject matter expert I guess gets to a microphone more 6 quickly, because it's kind of a background question.

7 10 CFR Part 50, Appendix B QA Program 8 requirements are applicable to power reactors, so they 9 are not in the strictest sense applicable to the SHINE 10 construction permit application. SHINE's slide 3 11 states that the application was prepared in accordance 12 with the criteria set forward in ANSI/ANS-15.8 QA for 13 research reactors.

14 Could someone though who is familiar -- I'm 15 more familiar with Appendix B and the component elements 16 of that. What is it that is missing or sacrificed in 17 terms of not using Appendix B versus using the ANSI/ANS 18 standard? Both to my knowledge provide for a graduated 19 approach to QA requirements, so is there any QA expert 20 of the staff or the Applicant who could tell me kind of 21 what is sacrificed between the two? I assume that the 22 Part B -- Appendix B, I'm sorry, QA Program is more 23 rigorous somehow.

24 Well, I mean, maybe -- and the other 25 question would be; and maybe this will be a follow-up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

131 1 or something to be answered at the end of the day, if 2 possible. Are all the requisite elements that are 3 required in an Appendix B program for coverage of 4 QA -- are those same elements addressed in the ANSI/ANS 5 standard?

6 MR. ADAMS: I think I can --

7 COMMISSIONER SVINICKI: Okay. Thank you.

8 MR. ADAMS: -- take a try at that. So 9 indeed the research reactors follow ANS 15.8, which is 10 endorsed by Regulatory Guide 2.5, Quality Assurance 11 Requirements for Research and Test Reactors. This 12 standard was developed by the ANS 15 Committee, Research 13 and Test Reactor Committee, and it was developed because 14 Appendix B did not apply to research reactors as 15 written.

16 The coverage areas are the same. In fact, 17 the ANS standard goes a little bit further because it 18 includes additional quality assurance area of 19 experiments, which you don't see in power reactors.

20 Also, the ANS standard was written with the realization 21 that the definition of SSCs in the regulations was 22 written for power plants and may not be strictly 23 applicable to research reactors.

24 Are you sacrificing something? The staff 25 does not believe so given the difference between power NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

132 1 reactors and research and test reactors. Based on the 2 Quality Assurance Program from SHINE, the answers to 3 RAIs and the scope of the standard, and also the Interim 4 Staff Guidance to NUREG-1537 we believe that using ANS 5 15.8 is applicable for meeting the requirements in 6 50.34(a)(7) for a Quality Assurance Program.

7 COMMISSIONER SVINICKI: Okay. Thank you.

8 That's a very complete answer. I don't require any 9 supplement to that. Thank you, Mr. Chairman.

10 CHAIRMAN BURNS: Okay. Well, thank you to 11 our morning panels for their presentations. We will 12 now adjourn until 1:30 p.m. and we'll take up Safety 13 Panel 2.

14 (Whereupon, the above-entitled matter went 15 off the record at 11:59 a.m. to reconvene at 1:30 p.m.)

16 CHAIRMAN BURNS: Okay, we'll call the 17 afternoon session of the hearing on the SHINE 18 application to order for a Construction Permit.

19 I'll ask the -- well, actually, what we'll 20 do, we'll hear both from the Applicant and then we'll 21 hear from the staff. The staff can stay where they are 22 for the time being.

23 But, we'll proceed with this afternoon's 24 panel. I'll remind the witnesses that they are under 25 oath and ask you to introduce yourselves again as we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

133 1 begin the afternoon session. And then, you can 2 proceed.

3 MR. COSTEDIO: I'm Jim Costedio. I'm the 4 SHINE Licensing Manager.

5 MR. HENNESSY: Bill Hennessy, the Manager 6 of Engineering for SHINE.

7 MS. KOLB: Catherine Kolb, I'm an 8 Engineering Supervisor.

9 MR. VAN ABEL: Eric Van Abel, Engineering 10 Supervisor.

11 CHAIRMAN BURNS: Okay, please proceed.

12 MR. VAN ABEL: Good afternoon.

13 For Safety Panel 2, I'd like to discuss the 14 Accident Analysis as presented in SHINE's PSAR.

15 The basis for identification of accidents 16 for our PSAR was a Hazards and Operability Study. We 17 performed the HAZOPS, a Preliminary Hazards Analysis, 18 a PHA. Both of those are rolled up into an Integrated 19 Safety Analysis.

20 We also used the events from NUREG-1537 and 21 the ISG augmenting NUREG-1537.

22 We used the experience of our hazards 23 analysis team which included folks experienced in 24 nuclear plant operations and engineering, personnel 25 experienced in reactor and nuclear process safety.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

134 1 Personnel familiar with process hazards 2 analysis and safety analysis modeling and methods, 3 personnel experienced with risk analysis and SHINE 4 system engineers familiar with the details of SHINE's 5 processes.

6 And, this analysis was all done based on our 7 preliminary design information and we do expect to 8 update it with detail design and submit an updated 9 safety analysis with our Operating License Application.

10 We performed qualitative evaluations 11 within categories of accidents and then performed 12 quantitative evaluation on the limiting accidents 13 within those categories.

14 We also postulated a Maximum Hypothetical 15 Accident which is typical of the research reactor 16 community. And that MHA was postulated for both the IF 17 and the RPF. And, I'll discuss both of those on the next 18 couple of slides.

19 Next slide, please?

20 In the IF, the MHA that we postulated was 21 a rupture of the target solution vessel and its 22 secondary vessel, the SASS, that surrounds it. So, 23 both of those vessels rupture, the target solution is 24 undergoing irradiation and spills into the IU cell.

25 We ignore the pool. This is all under NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

135 1 water, if you remember, and if we ignore that presence 2 of the pool so the material just spills and disperses 3 into the air.

4 The high radiation is detected in the IU 5 cell and that initiates isolation of the cell and 6 evacuation alarms for personnel.

7 The exhaust is filtered through HEPA 8 filters and charcoal absorbers and the calculated dose 9 consequences from that event are 3.1 rem TEDE to the 10 worker and 17 millirem at the fence for the public.

11 Next slide, please?

12 In the RPF, the MHA that we postulated was 13 found to have consequences more limiting than the IF 14 MHA, therefore, we designate it the facility MHA. And, 15 that event was the rupture of the noble gas storage tanks 16 in the noble gas removal system.

17 Those tanks store the off gas from those 18 eight irradiation units after the irradiation cycle.

19 It's stored there for decay and we postulated all five 20 of those tanks shown in blue on the figure on the right 21 there, rupture simultaneously and instantaneously.

22 The radiation in the room then initiates 23 confinement of that cell and high radiation alarms to 24 initiate evacuation.

25 Some material bypasses the isolation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

136 1 dampers and exposes and gets into the ductwork and 2 eventually to the public and some material leaks through 3 penetrations and exposes the workers.

4 Next slide, please?

5 The dose consequences for this event were 6 calculated to be 3.6 rem TEDE to the worker and 82 7 millirem at the fence for the public.

8 These consequences were calculated in a 9 conservative manner. There's several significant 10 conservatisms including a simultaneous instantaneous 11 rupture of these five tanks. These will be seismically 12 designed, safety-related tanks with proper isolation 13 between the tanks, so we would not expect multiple tanks 14 to rupture.

15 The tanks, also important to notice, that 16 there's additional isolation dampers in the exhaust 17 ductwork that would trap a large fraction of these 18 radionuclides later on before they get out to the 19 exhaust stack. But, those isolation dampers were not 20 credited in the analysis.

21 So, the dose consequences would be 22 significantly lower than those calculated here.

23 However, the consequences are within the limits of 10 24 CFR 20.1101, 1201 and 1301.

25 And, the figure on the right there shows the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

137 1 dose from the SHINE accident on the left most bar. The 2 center bar is the 10 CFR 20 limit and the bar on the right 3 is the 10 CFR 50.34 dose guidelines for power reactors 4 for comparison.

5 And, that concludes my presentation.

6 CHAIRMAN BURNS: Thank you.

7 Now, we'll ask the staff witnesses to come 8 forward.

9 And, I'll remind the witnesses that they're 10 under oath and I assume you all took the oath earlier 11 today, correct? Yes, and I want to remind you you're 12 under oath and why don't we begin with introductions of 13 the witnesses?

14 MR. MORRISSEY: I'm Kevin Morrissey, Fuel 15 Cycle Safety Review.

16 MR. LYNCH: Steve Lynch, Project Manager, 17 Research and Test Reactors Licensing.

18 MR. STAUDENMEIER: Joe Staudenmeier, 19 Senior Reactor Systems Engineer, Office of Research.

20 CHAIRMAN BURNS: Okay, thanks. Please 21 proceed.

22 MR. LYNCH: So, this panel will discuss the 23 unique accident analyses considerations for the SHINE 24 Utilization and Production Facilities.

25 I'll provide an introduction to the staff's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

138 1 review methodologies. Joe Staudenmeier and Kevin 2 Morrissey will then discuss the specific details of the 3 staff's review and findings.

4 Next slide, please?

5 Based on the anticipated hazards at the 6 SHINE facility, two methodologies were applied to 7 postulated accident scenarios. Postulated accidents 8 at the SHINE facility were evaluated against the 9 radiological exposure limits in 10 CFR Part 20.

10 Therefore, the SHINE workers are limited to 11 a total effective dose equivalent of five rem per year 12 while individual members of the public are limited to 13 100 millirem per year. This is consistent with the 14 exposure limits at existing research reactors.

15 The limiting radiological accident at the 16 SHINE facility is referred to as the Maximum 17 Hypothetical Accident, or MHA.

18 The MHA assumes a failure that results in 19 radiological releases and consequences exceeding those 20 of any postulated credible accident. The radiological 21 consequences resulting from the MHA are acceptable if 22 the resulting doses to workers and the public are less 23 than 10 CFR Part 20 exposure limits.

24 In addition to radiological exposure 25 considerations, the radioisotope production facility NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

139 1 accident analysis used consequence and likelihood 2 criteria for potential accidents resulting in chemical 3 exposures.

4 The staff evaluated SHINE's preliminary 5 radiological and chemical consequence likelihood 6 criteria, safety features and methods of assuring the 7 availability and reliability of safety features.

8 Since the processes and hazards associated 9 with the SHINE radioisotope production facility are 10 similar to those at fuel cycle facilities, the staff 11 determined that SHINE's use of integrated safety 12 analysis methodologies as described in 10 CFR Part 70 13 is an acceptable way of both selecting the MHA and 14 demonstrating safety.

15 Joe Staudenmeier will now discuss the 16 accident analysis considerations for the SHINE 17 irradiation facility.

18 MR. STAUDENMEIER: Thanks, Steve.

19 The SHINE irradiation units operate at low 20 power and low pressure and, therefore, have low forces 21 to drive a radiological release.

22 The target solution vessel and criticality 23 safe dump tank sit in a large pool of water that provides 24 passive decay heat removal.

25 The irradiated target solution and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

140 1 associated fission products and the tritium used in the 2 accelerators are the sources of radioactive material 3 that could be released during an accident.

4 Next slide, please?

5 SHINE has proposed and analyzed a set of 6 postulated accidents that should be representative of 7 the range of events that might happen in an operating 8 facility. Postulated accidents provide insights into 9 the challenges to the safety systems of the facility.

10 SHINE also analyzed how the potential 11 accidents might be prevented or mitigated by 12 administrative controls, engineered safety features 13 and trained personnel actions.

14 The dose consequences were calculated to 15 determine the limiting accident.

16 Next slide, please?

17 A typical SHINE accident scenario involves 18 a radioactive release into the irradiation unit pool or 19 atmosphere. The atmosphere in the irradiation unit is 20 connected by ducts to the ventilation system.

21 There are isolation dampers on the ducts 22 that close in the event of a high radiation signal.

23 Workers are evacuated on a high radiation alarm.

24 The releases reach the outside environment 25 after passing through filters. The calculated NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

141 1 releases are small enough that an acceptable emergency 2 planning zone could be the operational boundary.

3 Next slide, please?

4 The limiting accident for the irradiation 5 facility is a large rupture of one target solution 6 vessel. The target solution and associated fission 7 products are released and no credit is given for fission 8 product scrubbing by the pool.

9 The dose consequences from the limiting 10 accident in the irradiation facility are bounded by the 11 limiting accident in the radioisotope production 12 facility.

13 This accident is a rupture of all noble gas 14 removal system storage tanks where gases produced in the 15 irradiation process are stored while short-lived 16 radioisotopes decay.

17 The calculated total effective dose 18 equivalent is 3.59 rems for workers, 82 millirems for 19 members of the public at the site boundary and less than 20 12 millirems at the nearest residence.

21 The calculated doses meet the 10 CFR Part 22 20 acceptance criteria of five rem for workers and 100 23 millirem for members of the public.

24 Kevin Morrissey will now provide details on 25 the staff's evaluation of SHINE's radioisotope NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

142 1 production facility accident analysis.

2 Next slide, please?

3 MR. MORRISSEY: Thank you, Joe.

4 In order to satisfy the 50.34 requirement 5 that a preliminary safety analysis report must assess 6 the risk to the public health and safety, SHINE 7 performed an Integrated Safety Analysis of the 8 radioisotope production facility.

9 This analysis included radiological and 10 chemical hazard and accident analyses for this portion 11 of the facility.

12 The accident analyses determined the 13 facility hazards that needed to be protected against and 14 help establish the design basis for this area.

15 The purpose of the staff's review was to 16 determine that the proposed design of the radioisotope 17 production facility incorporated adequate capabilities 18 and features to prevent or mitigate potential accidents 19 and to protect the health and safety of the facility 20 workers and the public.

21 The staff's evaluation included review of 22 the following, the integrated safety analysis team, the 23 hazard evaluation process, the integrated safety 24 analysis methodology, the completeness of 25 identification of credible accident sequences, defense NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

143 1 in depth features of the design and safety related 2 design features such as process cells and facility 3 structures.

4 Next slide, please?

5 The staff reviewed multiple accident event 6 types such as radiological accidents including tank or 7 pipe failures and equipment malfunctions, chemical 8 accidents including tank or vessel failures and 9 exothermic reactions, criticality accidents, fires and 10 external events.

11 The review of SHINE's non-radiological 12 accidents included chemical safety related accidents 13 and determination of chemical safety controls.

14 The staff review looked at the equipment 15 and facilities that protect against releases of and 16 chemical exposures to licensed material or hazardous 17 chemicals produced from licensed material.

18 The staff also reviewed chemical risks of 19 plant conditions that affect the safety of licensed 20 material.

21 The staff determined that SHINE's 22 preliminary facility design proposed process 23 operations and safety controls for radiological and 24 chemical safety will perform their expected safety 25 function as intended and, thus, they will be adequate NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

144 1 to protect public health and safety and the environment.

2 The staff concludes that, for the purposes 3 of issuing a Construction Permit, there is reasonable 4 assurance that the proposed preliminary accident 5 analysis of the SHINE facility adequately assessed the 6 risk to public health and safety.

7 The analysis also acceptably supports the 8 determination of the facility hazards in the 9 preliminary safety design including the engineered 10 safety features that protect the health and safety of 11 workers and the public.

12 This concludes the staff remarks for Safety 13 Panel 2. And we are prepared to respond to any 14 questions at this time.

15 CHAIRMAN BURNS: Okay, thank you.

16 What I'd ask the staff witnesses to do is 17 maybe, Mr. Staudenmeier, if you can move to that seat, 18 move a little closer to the secretary and Mr. Morrissey 19 and Mr. Lynch and this way then we can all see each 20 other -- good visual from there and maybe just a little 21 bit closer to the secretary. That's good, that's good.

22 I believe we start the questioning, 23 Commissioner Baran.

24 COMMISSIONER BARAN: Thanks.

25 Steve and Joe, I wanted to -- now you're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

145 1 very far apart -- but, I wanted to ask you about the 2 Maximum Hypothetical Accident for the irradiation 3 facility.

4 As you mentioned, this involves failure of 5 one of the eight irradiation units. Now, in response 6 to pre-hearing questions five and six, the staff stated 7 that the irradiation units have been designed to 8 withstand any events that could cause multiple units to 9 fail simultaneously.

10 That's a pretty strong statement and I 11 wanted to give you a chance to talk to us about how you 12 reached that conclusion.

13 MR. STAUDENMEIER: Okay. As you said, the 14 units were isolated from each other, they're in robust 15 concrete shielding structures and they are designed to 16 withstand any design basis event like seismic or other 17 loadings on the system. And, there's no real way for 18 a failure in one to trigger failures in others or a chain 19 reaction.

20 COMMISSIONER BARAN: So, the staff looked 21 at tornados, earthquakes, floods, fires, aircraft 22 impacts, loss of offsite power and the staff concluded 23 that none of these events could cause more than one 24 irradiation unit to fail, is that right?

25 MR. STAUDENMEIER: Well, in terms of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

146 1 aircraft impact, the smaller aircraft that the type that 2 land at that airport, I know the facility is designed 3 to withstand impacts from those.

4 I don't think a large aircraft crash was 5 within the design basis of the facility.

6 COMMISSIONER BARAN: Okay, so with respect 7 to design basis events of those types?

8 MR. LYNCH: Yes, that is correct.

9 COMMISSIONER BARAN: Okay. Are there any 10 other kind of beyond design basis events besides larger 11 aircraft that you particularly have in mind that could 12 be an issue?

13 MR. LYNCH: Not at this time, no.

14 COMMISSIONER BARAN: Okay. And, you 15 alluded to this a little bit, Joe, but are there -- could 16 any of the common fill drain or off gas line shared by 17 the eight units result in an accident worse than the 18 Maximum Hypothetical Accident because of a common mode 19 failure?

20 MR. STAUDENMEIER: No, not that I'm aware 21 of. I mean, there's one common mode failure for cooling 22 to the TOGS system, I think, in long term, but the cells 23 would be isolated by that time and SHINE was going to 24 look at that for, I think they had a survival time of 25 four hours maybe for power lasting and they were going NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

147 1 to look at that in the Operating License Review.

2 COMMISSIONER BARAN: Okay. Well, let me 3 just give SHINE a chance if you wanted to add anything 4 on the Maximum Hypothetical Accident for the 5 irradiation units that the staff didn't cover.

6 MR. VAN ABEL: We did look at potential for 7 other events involving multiple units and we didn't 8 identify any potential events that would be worse than 9 the Maximum Hypothetical Accidents.

10 COMMISSIONER BARAN: Okay, thanks.

11 Pre-hearing question 29 asked about safety 12 features for the transfer of the target solution to the 13 radioisotope production facility after irradiation.

14 I'd like to ask the staff, what criticality 15 risks exist when the target solution is transferred and 16 how is that risk mitigated?

17 MR. LYNCH: Yes, I think Chris Heysel did 18 a review on engineered safety features. If you would 19 like to say a few words on that?

20 CHAIRMAN BURNS: Again, identify yourself 21 and confirm that you were previously put under oath.

22 MR. HEYSEL: For the record, my name is 23 Chris Heysel, I'm a Consultant with ISL. And, I did 24 take the oath earlier.

25 CHAIRMAN BURNS: Please be seated.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

148 1 MR. HEYSEL: The engineering safety 2 features are integral to both the IUs and the RPFs. So, 3 the both passive and active features will provide the 4 engineering safety features to mitigate normal and 5 upset conditions.

6 The design of those features will control 7 a criticality accident due to the geometries associated 8 with them.

9 COMMISSIONER BARAN: And, will the 10 criticality accident alarm system include coverage for 11 the entire path that the target solution travels during 12 transfer?

13 MR. HEYSEL: I am not the correct witness 14 to talk about the criticality alarm system.

15 COMMISSIONER BARAN: Okay.

16 Very quickly, anyone on the staff would 17 care to answer that?

18 MR. LYNCH: Chris Tripp, would you like to 19 discuss the criticality accident alarm system and the 20 areas of coverage?

21 COMMISSIONER BARAN: Just briefly.

22 CHAIRMAN BURNS: Identify yourself.

23 MR. TRIPP: Chris Tripp and I did take the 24 oath.

25 Yes, we don't have the design details of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

149 1 criticality alarm system in detail. However, SHINE has 2 not identified any areas where they'd be taking 3 exceptions.

4 So, anywhere there is special nuclear 5 material present, we understand that they would have 6 coverage of those areas.

7 COMMISSIONER BARAN: Okay, great. Thank 8 you.

9 Thanks, Mr. Chairman.

10 CHAIRMAN BURNS: I had a couple of 11 questions in terms of the review and the accident 12 analysis.

13 What are, and I think SHINE and/or the staff 14 can address this, what are the most significant natural 15 hazards that you had to focus your design on?

16 MS. KOLB: I guess we can go first.

17 So, we looked at natural hazards involving 18 flooding, as I spoke about earlier today. We looked at 19 the design basis aircraft, that's not really a natural 20 hazard, that's an external event.

21 We looked at the tornados, historical 22 maximum tornados. We used guidance from Regulatory 23 Guide, I believe it's 1.76 for the -- that's used for 24 power reactors for the spectrum and the wind speeds for 25 tornados.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

150 1 We looked at tornado missiles. Anything 2 else I'm missing? I mentioned flooding.

3 CHAIRMAN BURNS: Okay. And, staff, do you 4 want to add on to that?

5 MR. LYNCH: The one other thing that SHINE 6 did look at this as well in addition to staff was the 7 rain-snow load on the facility as well as an external 8 event.

9 CHAIRMAN BURNS: In terms of the roof of the 10 building?

11 MR LYNCH: Yes, yes.

12 CHAIRMAN BURNS: Okay.

13 MR. LYNCH: Yes.

14 CHAIRMAN BURNS: Okay.

15 There's just -- actually, part of our 16 discussion focused on not only radiological hazards, 17 but chemical hazards and, I think in the description of 18 the facility, for example, sulfuric acid is used in part 19 of the process.

20 What are the significant potential 21 chemical hazards that are involved with the facility?

22 MR. VAN ABEL: For SHINE.

23 We looked at a variety of chemical hazards 24 in the facility. We do have sulfuric acid, nitric acid, 25 other acids and bases.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

151 1 We identified 24 chemicals of concern that 2 we use throughout the process and 11 of them were 3 explicitly modeled because of their -- either their 4 toxicity, their dispersibility or inventory. And that 5 includes things like the acids I mentioned, calcium 6 hydroxide, caustic soda, ammonium hydroxide, 7 N-dodecane, potassium permanganate, tributyl phosphate 8 which is part of the UREX process and uranyl nitrate and 9 a couple of proprietary chemicals as well.

10 CHAIRMAN BURNS: Okay. From the -- go 11 ahead, Mr. Lynch.

12 MR. LYNCH: Yes, I would just say as far as 13 the chemical hazards and concern, the staff is expecting 14 hazardous chemicals to be in very small quantities at 15 the facility.

16 The only chemicals that could exceed large 17 quantities which we're considering to be greater than 18 1,000 pounds would be nitric acid or sulfuric acid.

19 And, there are a number of processes that we are 20 evaluating that involve these chemical hazards and this 21 includes the preparation of the target solution vessel, 22 the radioisotope production, extraction and 23 purification system, target solution clean up and any 24 waste operations.

25 CHAIRMAN BURNS: Okay. In terms of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

152 1 control of those types of hazards, do we look primarily 2 to the regulatory footprint or authority of other 3 agencies or how is that integrated in terms of what the 4 staff would evaluate in terms of acceptability for both 5 the Construction Permit, but looking forward, if we came 6 to a point of an Operating License, what would we do?

7 MR. MORRISSEY: Well, typically, we 8 evaluate chemical hazards in Part 70 under 70.61. So, 9 we use that and SHINE, that is one acceptable way of 10 doing things and SHINE preferred to take that way.

11 CHAIRMAN BURNS: Okay.

12 MR. MORRISSEY: And so, 70.61 provides 13 guidance through 1520 on, you know, how to do chemical 14 safety evaluations.

15 CHAIRMAN BURNS: Okay. And, just to 16 confirm my understanding on the Maximum Hypothetical 17 Accident that was described is, I understand, or the 18 slides in the presentation, in that event, the 19 expectation would be that a worker dose would be less 20 than the normal occupational dose that is permitted 21 under Part 20, is that correct? I thought I heard 22 something like 3 point X rem.

23 MR. VAN ABEL: Yes.

24 CHAIRMAN BURNS: Okay.

25 MR. VAN ABEL: That's correct.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

153 1 CHAIRMAN BURNS: And then, the site 2 boundary dose to the public would be 82 millirem as 3 opposed to the 100 millirem? So, then what we're -- at 4 least from our understanding at this point for purposes 5 of Construction Permit, is you have doses that are 6 actually below what we'll call normal dose limitations?

7 MR. LYNCH: Yes, that is correct.

8 CHAIRMAN BURNS: Okay.

9 There was a comment with respect to, and 10 again, looking forward, we're not deciding emergency 11 preparedness requirements in this context today, but 12 there was a comment made and I don't -- I think it may 13 have been one of the staff witnesses, but it may have 14 been SHINE, with respect to the size the -- or the, I 15 guess, not size but, perhaps, boundary of an emergency 16 planning zone was described as the operational 17 boundary.

18 Can you describe for me what that means?

19 Does that mean the building or does that mean the 20 owner -- what I would call the owner controlled area?

21 MR. LYNCH: Yes, the operational boundary 22 would be the building itself. And, just to clarify, 23 that is something the staff is still evaluating as to 24 what in the Operating License.

25 CHAIRMAN BURNS: No, I understand, but I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

154 1 appreciate that clarification.

2 That's all I have.

3 Commissioner Svinicki?

4 COMMISSIONER SVINICKI: Thank you for your 5 presentations on this panel which were principally 6 regarding Chapter 13 Accident Analysis.

7 In my preparation between reviewing the 8 record itself and the supplements given in the response 9 to pre-hearing questions, I found there to be a very 10 complete and exhaustive discussion of the Maximum 11 Hypothetical Accident. So, I was satisfied with 12 answers to my questions on those points.

13 So, I do have two questions that relate to 14 Chapters 11 and 12. And, Chapter 11 addresses waste 15 management issues.

16 This is for, I think both of my questions 17 will be for the Applicant witnesses.

18 SHINE has indicated that greater than Class 19 C low level waste would be generated as a result of 20 operating the facility, is that correct?

21 MS. KOLB: Yes, we do have that in our PSAR.

22 COMMISSIONER SVINICKI: Okay. So, my 23 question is, if there is no national disposal pathway 24 for your greater than Class C waste, would you have 25 adequate ability to store that on your site for the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

155 1 lifetime of the operations of the facility?

2 MS. KOLB: Before I answer that --

3 COMMISSIONER SVINICKI: If not, what is 4 your other alternative plan?

5 MS. KOLB: So, our designations of greater 6 than Class C waste are two small waste streams and that's 7 based on our preliminary design and some conservative 8 assumptions.

9 It's possible when we refine the design 10 that we may limit or eliminate that waste stream but, 11 as it stands, we've had discussions with some licensed 12 disposal facilities that have the ability to store 13 greater than Class C waste.

14 If SHINE did not have a commercial path, 15 either at Waste Control Specialists or some other 16 commercial disposal or storage facility, then the 17 provision of the American Medical Isotope Production 18 Act has a provision to accept the wastes from medical 19 isotope productions and that's what we would --

20 COMMISSIONER SVINICKI: And that --

21 MS. KOLB: And that would be our fallback 22 position.

23 COMMISSIONER SVINICKI: And that 24 provision in the Act is for the Department of Energy or 25 U.S. Government to take that waste?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

156 1 MS. KOLB: The Department of Energy, 2 that's correct.

3 COMMISSIONER SVINICKI: Okay, thank you.

4 And then Chapter 12 is conduct of 5 operations, but broadly, as SHINE looks to the future 6 and the possible need for qualified operators, very 7 conceptually, what do you envision as the skills, 8 knowledge and abilities of the types of experience that 9 a qualified operator for this type of facility would 10 have? Is it someone who has operated power reactors or 11 research and test reactors? Would that be in general 12 the requisite skill set or is it only requiring some sort 13 of smaller set of knowledge skills and abilities?

14 MR. COSTEDIO: I mean, certainly, we'd 15 entertain the hiring folks with prior power reactor 16 experience and that would be good. Also, nuclear Navy 17 and engineers out of college.

18 We plan on having a training program in 19 accordance with NUREG-1478 for research and test 20 reactors, that's how they license their operators.

21 We do have to do some work, you know, with 22 the staff on that to line that up with what we do. But, 23 we certainly plan on having a rigorous SAT-based, you 24 know, training process with exams and very, very similar 25 to what the research and test reactors do now.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

157 1 COMMISSIONER SVINICKI: Would you 2 envision having any sort of partnership with local maybe 3 technical colleges or others to develop a kind of a 4 qualified worker base for this facility going forward?

5 Is that something you've thought about?

6 MR. COSTEDIO: Yes, with Blackhawk 7 College, we've talked with them.

8 Do you have more?

9 MR. HENNESSY: We have been working with 10 the local technical colleges. There's one up in 11 Northeast Wisconsin which is in partnership with the one 12 down by Janesville that has done a lot of training for 13 RP personnel to work at the power plants that are up 14 there.

15 And so, they've been looking at 16 transferring those programs down to the Janesville area 17 and we expect that will be very useful to us to help find 18 good staff to staff our facility.

19 COMMISSIONER SVINICKI: Okay, thank you.

20 Thank you, Mr. Chairman.

21 CHAIRMAN BURNS: Thank you.

22 Commissioner Ostendorff?

23 COMMISSIONER OSTENDORFF: Thank you, Mr.

24 Chairman.

25 I'm going to start off with the Applicant, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

158 1 please.

2 I recognize the unique nature of SHINE that 3 weve conceptually looked at today. Is there anything 4 in the radiation detection arena as far as equipment 5 monitoring instrumentation that you would characterize 6 as never tried before or first-of-a-kind engineering or 7 first-of-a-kind instrumentation?

8 MR. VAN ABEL: No -- we have various 9 radiation area monitors in the facility, continuous air 10 monitors, standard off-the-shelf type technology.

11 We're looking at neutron flux detectors to 12 monitor the reactivity and the neutron population in the 13 TSV during irradiation.

14 And, we're talking to existing vendors who 15 supply research reactors with that technology and it's 16 all within normal --

17 COMMISSIONER OSTENDORFF: So, as far as 18 neutron detectors, you expect to be able to use some 19 technology that's already on the market for that?

20 MR. VAN ABEL: Oh, yes, yes, that is 21 correct.

22 COMMISSIONER OSTENDORFF: Okay.

23 Real quick, did the staff see any 24 challenges in this area for either radiation protection 25 or detection device approaches?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

159 1 MR. LYNCH: As of now, we have not.

2 COMMISSIONER OSTENDORFF: Okay.

3 All right, let me go back to the Applicant 4 real quick.

5 On your slide four, several times there's 6 reference to the isolation dampers. I know dampers 7 seem pretty straightforward, but dampers can be 8 complex. Are these manually operated? Are they 9 operated by some solenoid or hydraulic system or can you 10 talk about, in an accident scenario, how they'd be 11 operated?

12 MR. VAN ABEL: We haven't selected the 13 dampers yet. They would not be manually operated, 14 they'd be operated by some actuation mechanism, 15 hydraulic or pneumatic.

16 We've looked at vendors that supply these 17 for the nuclear industry and there are many choices 18 available that we think will meet our criteria, but they 19 would be automatic actuated by the safety systems and 20 they would be fail close so their fail position would 21 be closed if you lose offsite power, they would close 22 automatically.

23 COMMISSIONER OSTENDORFF: And the use of 24 the word redundant in front of isolation dampers, does 25 that mean there's more than one damper in the flow path NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

160 1 of the ventilation?

2 MR. VAN ABEL: It means -- yes, nominally 3 there would be two dampers at every place that you need 4 an isolation capability.

5 COMMISSIONER OSTENDORFF: All right, 6 thank you.

7 I have no further questions.

8 CHAIRMAN BURNS: I was about to -- I did 9 this last time, last year, I always went to Commissioner 10 Baran again, to redo a round, but I take it without 11 anything else, we'll dismiss this panel.

12 Thank you for your testimony and we'll call 13 up the environmental panel.

14 (Whereupon, the above-entitled matter went 15 off the record at 2:06 p.m. and resumed at 2:08 p.m.)

16 CHAIRMAN BURNS: Well, thank you, again.

17 And, we'll, again, with this panel, we'll 18 have the testimony of the Applicant and then the staff 19 testimony, then proceed to questioning.

20 Again, I remind all the witnesses that they 21 remain under oath and I'll ask you, when you start again 22 and ask you to introduce yourselves, first for the SHINE 23 witnesses.

24 MS. PITAS: Certainly. My name's Katrina 25 Pitas. I'm the Vice President of Business Development NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

161 1 for SHINE.

2 CHAIRMAN BURNS: Okay.

3 MR. HENNESSY: Bill Hennessy, Manager of 4 Engineering for SHINE.

5 MS. KOLB: Catherine Kolb, Engineering 6 Supervisor.

7 MR. KRAUSE: I'm Tim Krause. I'm an 8 Environmental Coordinator for the project.

9 CHAIRMAN BURNS: Okay. And, why don't you 10 all start?

11 MS. PITAS: Thank you.

12 So, I'm going to give the environmental 13 overview for SHINE today.

14 Next slide, please?

15 On this first slide, you will see some 16 pictures of some of the site characterization work that 17 was done. We began that work back in October of 2011 18 at the Janesville site which was chosen for the SHINE 19 facility.

20 And, we did that site characterization work 21 to develop the environmental report which followed the 22 final Interim Staff Guidance augmenting NUREG-1537.

23 Next slide, please?

24 This table shows the structure and the 25 content of the Environmental Report. After NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

162 1 introducing the project, the Environmental Report goes 2 on to discuss the proposed action. It then goes into 3 a detailed description of the affected environment and 4 the resources of the chosen site, Janesville.

5 Then, it goes on to analyze both the impacts 6 and the benefits of the SHINE technology on the chosen 7 site.

8 And then, it compares the impacts of the 9 SHINE technology at the Janesville site with the impacts 10 of the no-action alterative, what the impacts of the 11 SHINE technology would be at two alternative sites, 12 Chippewa Falls and Stevens Point.

13 And then, it looks at the impacts of two 14 alternative technologies.

15 It then goes on to discuss the conclusions 16 reached by the report.

17 Next slide, please?

18 The field investigations we needed to do to 19 gather the information to complete the environmental 20 report were thorough and very extensive.

21 In addition to a Phase I environmental site 22 assessment and general site reconnaissance, the 23 geotechnical investigation consisted of 15 soil 24 borings, one of which was used for seismic 25 characterization, four of which were converted to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

163 1 groundwater monitoring wells.

2 A Phase I archaeological investigation, a 3 baseline visual assessment and a wetland delineation 4 were all performed as well as ecological investigations 5 that consisted of quarterly field surveys over the 6 course of one year. Those looked at both aquatic 7 ecology and terrestrial ecology.

8 And, monthly ground and surface water 9 monitoring that looked at both water quality and water 10 levels.

11 Next slide, please?

12 The context for our data acquisition varied 13 depending on which resource was being analyzed. Many 14 of the investigations looked just at the SHINE parcel 15 itself which, as has been mentioned, is a 91-acre parcel 16 on the south side of Janesville, Wisconsin.

17 Some of the investigations looked a little 18 bit broader at the project area which we consider to be 19 the one mile radius from the site center point.

20 And then, other investigations looked at 21 the entire region surrounding the SHINE site, often up 22 to five miles in all directions from the center point.

23 And then, for some of the resources like 24 geology and air quality, we looked at even larger 25 contexts as was appropriate to the resource.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

164 1 For socio-economic impacts, we looked at 2 what is known as the region of influence. That 3 corresponds to the area that incurs the greatest impacts 4 to community services that result from the SHINE 5 facility and the people who work at the SHINE facility.

6 We determined that to be Rock County, Wisconsin.

7 Next slide, please?

8 We also conducted a number of consultations 9 in preparation for the environmental report.

10 We talked to the City of Janesville, Rock 11 County, the Wisconsin Department of Natural Resources, 12 the Wisconsin State Historic Preservation Office, the 13 Wisconsin Department of Transportation, the U.S. Fish 14 and Wildlife Service, the Federal Aviation 15 Administration, the Bureau of Indian Affairs and we also 16 contacted 13 Native American Tribes including two 17 Tribes located within the State of Wisconsin and 11 18 Tribes that were non-Wisconsin Tribes.

19 Next slide, please?

20 In addition to the impacts of constructing 21 and operating the SHINE facility at the Janesville site, 22 SHINE analyzed two alternative sites and the no-action 23 alternative.

24 The SHINE project, as has been discussed, 25 results in a number of local, national and global NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

165 1 benefits. These include the socio-economic benefits 2 for the local community consisting of tax benefits and 3 increased job opportunities.

4 The SHINE project also lends support for 5 U.S. Government policies to encourage domestic 6 production of medical isotopes and nonproliferation.

7 But, most of all, the SHINE project results 8 in health benefits from a reliable, stable supply of 9 technetium-99m, for patients around the globe.

10 So, in light of these benefits, the 11 no-action alternative is not preferable to the 12 construction and operation of the SHINE facility.

13 Although the no-action alternative would 14 avoid the environmental impacts associated with the 15 SHINE project, because all of these impacts are small 16 for the SHINE technology, avoiding these impacts is not 17 significant.

18 And, the no-action alternative would not 19 impart the important benefits that I mentioned before.

20 Looking at the two alternative sites, 21 Chippewa Falls and Stevens Point, neither alternative 22 site would reduce or avoid adverse impacts as compared 23 with the SHINE site.

24 As shown in this table, the Janesville site 25 is the preferred site from an environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

166 1 perspective, given that it has small impacts to all 2 resource categories while the alternatives had moderate 3 impacts to some resource categories during 4 construction.

5 Next slide, please?

6 SHINE also analyzed two -- the 7 environmental impacts of two alternative technologies, 8 both the linear accelerator technology that would be 9 creating moly-99 from enriched or natural molybdenum 10 targets and a low enriched uranium aqueous homogeneous 11 reactor.

12 Both of these technologies are considered 13 reasonable alternatives to the SHINE technology for the 14 Janesville site from an environmental perspective.

15 But, neither of the alternative technologies would 16 reduce or avoid adverse impacts as compared with the 17 SHINE technology.

18 Next slide, please?

19 In mid-2013, the NRC staff conducted an 20 environmental site audit. SHINE gave the staff 21 presentations on the SHINE technology and our site 22 selection process.

23 The staff then made a number of visits to 24 places of interest in the community. Those included 25 the Janesville site and the surrounding area. We went NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

167 1 on a driving tour of about 4.4 miles around the site.

2 We visited the Rock River. We visited the 3 sites that were used for sampling along the nearby 4 unnamed tributary. We visited the Janesville 5 Wastewater Treatment Facility which included a look at 6 the outfall structure to the Rock River.

7 And, we looked at both alternative sites.

8 We traveled both to Stevens Point and to Chippewa Falls.

9 Next slide, please?

10 SHINE believes the relationships between 11 the company, the City of Janesville and the State of 12 Wisconsin are incredibly important and we worked very 13 hard to build and continuously strengthen those 14 relationships via a policy of transparency and frequent 15 engagement.

16 Supporting these principles, we ensure a 17 minimum of four public meetings with the community per 18 year, as I had mentioned earlier. And, actually, the 19 most recent of those happened on December 9th.

20 As a result of these activities and these 21 efforts, we have a relationship with the community 22 that's based on trust, mutual respect and, I believe, 23 genuine enthusiasm for the SHINE project.

24 Next slide, please?

25 In conclusion, the SHINE environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

168 1 review was conducted pursuant to 10 CFR Part 51 and is 2 adequate. The requirements of Sections 102(2)(A), (C) 3 and (E) of the National Environmental Policy Act have 4 been satisfied and SHINE's weighing and balancing of the 5 environmental, technical and other costs and benefits 6 of the SHINE facility supports issuance of the 7 Construction Permit.

8 Thank you.

9 CHAIRMAN BURNS: Okay, thank you.

10 We'll proceed now with the staff testimony 11 and I'd ask the staff witnesses to identify themselves 12 and then you can proceed.

13 MS. MARSHALL: My name is Jane Marshall.

14 I'm the Deputy Director for the Division of License 15 Renewal in the Office of Nuclear Reactor Regulation.

16 MR. WRONA: I'm David Wrona, the Chief of 17 the Environmental Review Branch in the Office of NRR.

18 MS. MOSER: My name is Michelle Moser.

19 I'm the Environmental Project Manager in NRR.

20 CHAIRMAN BURNS: Okay, thank you.

21 Proceed.

22 MS. MARSHALL: Okay, thanks.

23 If I can have -- you've got my slide, thank 24 you.

25 Good afternoon. I'm Jane Marshall and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

169 1 with me today to discuss the environmental review of the 2 SHINE facility are Dave Wrona and Michelle Moser.

3 Next slide, please?

4 As I mentioned during my presentation 5 earlier this morning, part of the staff's review of the 6 SHINE Construction Permit Application included an 7 environmental review which was conducted in parallel 8 with the safety review that you heard about earlier 9 today.

10 The staff performed the environmental 11 review in accordance with the National Environmental 12 Policy Act of 1969, commonly referred to as NEPA.

13 In doing it's NEPA review, the staff 14 followed the environmental review process for preparing 15 an Environmental Impact Statement, commonly referred to 16 as an EIS, as described in 10 CFR Part 51 and in the 17 Interim Staff Guidance augmenting NUREG-1537.

18 The following presentations provide an 19 overview of the environmental review for the SHINE 20 Application while highlighting the unique aspects of 21 this review.

22 The three novel issues that we will 23 highlight today include the staff's decision to prepare 24 an EIS, the inclusion of the Department of Energy as a 25 cooperating Agency and the NRC staff's analysis to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

170 1 determine the range of reasonable alternatives analyzed 2 in the EIS.

3 And now, I turn it over to Dave Wrona.

4 MR. WRONA: Thank you, Jane.

5 One of the first steps in the environmental 6 review process was determining the appropriate 7 methodology for the environmental review and the level 8 of detail for staff findings.

9 Environmental reviews for licensing 10 actions fall into one of three categories, those 11 identified as categorical exclusions and not requiring 12 further evaluation, those requiring the preparation of 13 an environmental assessment, commonly referred to as an 14 EA and those requiring the preparation of an EIS.

15 Licensing actions that require an EIS are 16 described in 10 CFR 51.20. The proposed issuance of a 17 Construction Permit for a medical radioisotope 18 production facility is not specifically listed in 10 CFR 19 51.20.

20 Such licensing actions would require an EA 21 or an EIS, depending on project-specific activities and 22 site-specific conditions that could impact the actions 23 potential to significantly affect the quality of the 24 human environment.

25 After reviewing SHINE's environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

171 1 report, the staff made a project-specific determination 2 that an EIS would be appropriate to assess the 3 environmental impacts of the proposed 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 unique 8 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.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

172 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 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 written 17 letters from members of the public, the Wisconsin 18 Department of Natural Resources, the U.S. Environmental 19 Protection Agency and the Forest County Potawatomi 20 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

173 1 alternative sites and technologies.

2 The staff responded to all comments 3 received during the scoping period in a Scoping Summary 4 Report. It included relevant information from in scope 5 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 NRC 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 unique 19 aspect of this review. The coordination with DOE was 20 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 to 25 the maximum extent practicable that environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

174 1 reviews for facilities to produce medical radioisotopes 2 are complimentary and not duplicative.

3 Therefore, NRC and DOE developed a 4 Memorandum of Agreement to make effective and efficient 5 use of federal resources during the review of the SHINE 6 Construction Permit Application.

7 The goal of the agreement was to develop a 8 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 cooperating 12 agency for developing the EIS for the proposed SHINE 13 facility.

14 Under NEPA, the lead agency, or NRC in this 15 case, has the primary role in preparing the EIS while 16 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 the site, considered scoping comments 24 and 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

175 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 small 21 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.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

176 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 1,000 9 trips per day from construction activities and up to 580 10 trips a day from decommissioning activities at the 11 proposed SHINE site would result in increased traffic 12 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 hours0.667 days <br />0.0952 weeks <br />0.0219 months <br /> 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.

25 The NRC implements this requirement NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

177 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 the 11 environmental impacts of the no-action alternative or 12 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.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

178 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 a 6 large number of potential alternatives exist.

7 In such situations, NEPA only requires that 8 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.

25 The staff also selected new technologies NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

179 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 publicly 19 available documents that describe the air emissions, 20 estimated dose exposures, water use, building heights 21 and footprints and other environmental parameters to 22 assess the environmental impacts for each alternative 23 technology.

24 DOE's environmental assessment for the 25 North Star facility provided sufficient environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

180 1 data to conduct a meaningful, in depth analysis for the 2 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 site, 24 the impacts to all resource areas, expect for traffic, 25 would be small. The impacts to traffic would be small NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

181 1 to moderate because of the noticeable increase in 2 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 to 10 moderate at both Chippewa Falls and Stevens Point in 11 part because the nearest resident would be closer than 12 at the Janesville site and, therefore, the noise would 13 be more audible to the closest resident.

14 The impacts to visual resources would be 15 small to moderate at the Stevens Point site because the 16 site and much of the surrounding area is forested. In 17 clearing onsite forests during construction would 18 increase the visibility of the new facility, especially 19 in contrast to the surrounding forested area.

20 Similar to the proposed Janesville site, 21 the impacts at both Chippewa Falls and Stevens Point 22 would be small to moderate for traffic.

23 Therefore, the staff concluded that the 24 Janesville site would be the environmentally preferable 25 alternative.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

182 1 Under the no-action alternative, no 2 changes would occur to the proposed SHINE site in 3 Janesville, Wisconsin. The site would remain zoned for 4 light industrial use. Therefore, impacts on all 5 resource areas would be small.

6 However, the no-action alternative does 7 not meet the stated purpose and need to provide a medical 8 radioisotope production option that could help meet the 9 need for a domestic source of molybdenum-99.

10 Slide 13, please?

11 In terms of the benefits considered, the 12 proposed action would result in several societal, 13 medical and economical benefits.

14 For example, the proposed action is in 15 accordance with U.S. policy to ensure a reliable supply 16 of medical radioisotopes while minimizing the use of 17 highly enriched uranium.

18 In addition, the production of 19 molybdenum-99 would increase availability of medical 20 radioisotopes for U.S. public health needs.

21 And, lastly, constructing and operating 22 the proposed SHINE facility would result in economic 23 benefits such as tax revenue and employment 24 opportunities to communities located near the 25 Janesville site.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

183 1 Based on the small environmental impacts 2 associated with the proposed SHINE facility at the 3 Janesville site and the benefits to the U.S. medical 4 community, the efforts to support U.S. policy to produce 5 a domestic supply of molybdenum-99 using low enriched 6 uranium and the economic tax and employment benefits 7 associated with construction and operation of the SHINE 8 facility, the staff determined that the benefits 9 outweigh the small environmental costs.

10 Next slide, please?

11 In addition to NEPA, the NRC may address 12 other regulatory requirements within its EIS. For 13 example, the staff conducted a review of potential 14 impacts to the threatened and endangered species as 15 required by the Endangered Species Act.

16 Under this Act, the staff must consult with 17 the U.S. Fish and Wildlife Service to determine whether 18 threatened and endangered species could occur on the 19 proposed site and, if so, if the proposed action would 20 affect such species.

21 The proposed action would have no effect on 22 threatened and endangered species because the proposed 23 site is primarily an agricultural field and does not 24 provide suitable habitat for any threatened or 25 endangered species.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

184 1 In a letter to the NRC, the U.S. Fish and 2 Wildlife Service stated that no federally listed 3 proposed or candidate species would be expected within 4 the project area and no further action is required by 5 the Endangered Species Act if SHINE constructs the 6 proposed facility on the Janesville site.

7 Under Section 106 of the National Historic 8 Preservation Act, the staff is required to first 9 determine whether historic properties would be affected 10 by the proposed action.

11 If historic properties would be affected, 12 then the staff determines whether the effects would be 13 adverse.

14 The proposed action would have no impact on 15 known historic and cultural resources because the staff 16 did not identify any historic and cultural resources 17 eligible for protection under the National Historic 18 Preservation Act.

19 In July 2015, the Wisconsin Historical 20 Society concurred with the staff's determination that 21 no historic properties would be affected.

22 Slide 15, please?

23 On May 11, 2015, staff issued the draft EIS 24 for public comment. During this comment period, the 25 staff requested input from the public and other federal, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

185 1 state and local agencies regarding the data analyses and 2 conclusion in the draft EIS.

3 During this comment period, the NRC held 4 two public meetings in Janesville, Wisconsin. One 5 member of the public provided an oral statement at the 6 meetings.

7 In addition, the staff received eight 8 written letters from members of the public, Wisconsin 9 Department of Natural Resources, the U.S. Environmental 10 Protection Agency, Peoria Tribe of Indians of Oklahoma 11 and from SHINE.

12 In-scope comments addressed a variety of 13 environmental issues including the potential impacts 14 from accidents due to aircrafts, storage of radioactive 15 waste, greenhouse gases and climate change, potential 16 contamination to nearby agricultural lands and 17 alternative sites and technologies.

18 The staff responded to all comments in the 19 final EIS which was published on October 16, 2015. The 20 staff revised the final EIS based on the in-scope 21 comments and based on newly available information since 22 the publication of the draft EIS.

23 Next slide, please?

24 In accordance with 10 CFR 51.105(a), the 25 staff weighed the environmental, economical and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

186 1 technical costs and benefits for the proposed action, 2 alternative sites and the alternative technology and 3 the no-action alternative.

4 Based on the small environmental impacts 5 associated with the proposed SHINE facility at the 6 Janesville site and the societal, medical and economic 7 benefits associated with the proposed SHINE facility, 8 the staff determined that the benefits outweigh the 9 small environmental costs.

10 Therefore, in the EIS, the staff recommends 11 the issuance of the Construction Permit.

12 Slide 17, please?

13 The issuance of a Construction Permit is a 14 separate licensing action from the issuance of an 15 Operating License. If the NRC issues a Construction 16 Permit, 10 CFR part 50 requires that SHINE submit a 17 separate Application for an Operating License.

18 If SHINE were to submit an Application for 19 an Operating License for a production or utilization 20 facility, the staff would prepare a supplement to the 21 EIS in accordance with 10 CFR 51.95(b).

22 The supplement to the final EIS would 23 update the environmental review by discussing issues or 24 topics not included in the final EIS and any new and 25 significant information regarding matters discussed in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

187 1 the final EIS.

2 The staff would follow the environmental 3 review process outlined in 10 CFR Part 51 in preparing 4 the supplement to the EIS, including scoping, 5 requesting comments on the EIS and updating the 6 supplement to the EIS based on public comments received.

7 This concludes the staff's remarks in the 8 Environmental Panel. We are prepared to answer any 9 questions you may have.

10 CHAIRMAN BURNS: Okay. And, what I might 11 ask you to do is do a little bit of shuffle again so we 12 can all see.

13 And, I'll start off with questions.

14 I found it interesting, Mr. Wrona, that 15 there was a -- your testimony discussed the question of 16 whether or not an Environmental Impact Statement would 17 have been prepared for this site.

18 Was there really a serious question that 19 there would not have been an EIS for a project of this 20 kind?

21 For example, if this were a research 22 reactor, would that have normally required an EIS?

23 MR. WRONA: The issuance of a Construction 24 Permit for a research reactor would not, again, be in 25 10 CFR Part 51.20 as required to have an EIS issued.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

188 1 We look at these on a case by case basis.

2 So, it would depend on what the proposed action is and 3 what is going on at the site where they're proposing.

4 CHAIRMAN BURNS: Okay. So, in sum, you 5 would say that the two major factors or the major factors 6 that led the staff to conclude that an EIS was an 7 appropriate means of addressing our NEPA obligation 8 were what?

9 MR. WRONA: It was, for the SHINE case, the 10 unique first-of-a-kind application was one of the 11 things and the main thing that led us to develop an EIS 12 for SHINE. That was pretty much the main issue for 13 development of an EIS.

14 CHAIRMAN BURNS: Okay, all right, thanks.

15 I think, Ms. Moser, you, in discussing the 16 alternative technologies, one thing I think I heard you 17 say is that the staff excluded from consideration as 18 alternative technologies, technologies used outside of 19 the United States.

20 I'm trying to understand that because what 21 that includes, is that basically using what is currently 22 the source, which are research reactors?

23 MS. MOSER: Correct. We excluded that 24 from further detailed studies.

25 CHAIRMAN BURNS: Okay, so there isn't some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

189 1 other newer technology that's being considered at this 2 point? I'm just trying to understand the scope of 3 what -- it was interesting how you said that.

4 So, basically, what it was, you were not 5 considering production in a research reactor such as is 6 currently conducted is what you're saying?

7 MS. MOSER: Correct, outside of the -- yes, 8 that is currently occurring outside of the United States 9 and we eliminated that from further study within our 10 alternative technology analysis.

11 CHAIRMAN BURNS: Okay.

12 One of the things you also just spoke to in 13 terms of describing the comments was comments that were 14 within scope. I presume were some of the comments what 15 you considered out of scope and what would they be?

16 Where, I don't like any of this kind of technology, 17 is that what I should conclude from that?

18 MS. MOSER: Yes, we received a few comments 19 that expressed opposition to the facility which we 20 considered out of scope for the environmental impact 21 statement.

22 Other out of scope comments included --

23 CHAIRMAN BURNS: But, why were they out of 24 scope? They can -- it's fine to be against the facility 25 but you have to have some -- I presume there has to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

190 1 some content there that is relevant to the 2 considerations we take into account?

3 MS. MOSER: Correct. If it would have 4 described environmental concerns that should have 5 been -- that were within the scope of what we analyzed 6 in the Environmental Impact Statement such as concerns 7 from potential accidents, then that we would have 8 considered within scope and that we would have analyzed 9 within the EIS.

10 CHAIRMAN BURNS: Okay.

11 You said that there were no historic or 12 archaeological or the impact on historic or 13 archaeological resources wasn't an identified.

14 You did receive one, maybe two comments 15 from Tribal organizations. What was the nature of 16 those comments?

17 MS. MOSER: Both of the Tribes that 18 submitted comments to us expressed that they wanted to 19 know additional information if any studies occurred or 20 if there was an inadvertent find of something like human 21 remains, they wanted to be notified.

22 CHAIRMAN BURNS: Okay. So, they want to 23 be informed if further studies were done or significant 24 remains of some kind?

25 MS. MOSER: Well, to clarify, one of them NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

191 1 asked for a copy of the study that was conducted onsite.

2 CHAIRMAN BURNS: Okay, okay. All right, 3 thanks.

4 I wanted -- the last question I have, I want 5 to understand in terms of the assessment of alternative 6 sites and the Chippewa Falls site and the Stevens Lake 7 or Stevens Point, thank you, Commissioner, Stevens 8 Point site.

9 You described and I saw also in the 10 Applicant's presentation that the differences in 11 impacts were moderate or described as moderate with 12 respect to the Stevens Point and Chippewa site.

13 And, I think you describe it that that 14 became moderate because of noise consideration. Is 15 that the only thing that reached your assessment that 16 it would become a moderate impact?

17 MS. MOSER: At Stevens Point, it was noise, 18 visual resources --

19 CHAIRMAN BURNS: Oh, visual, that's right.

20 MS. MOSER: -- and traffic.

21 CHAIRMAN BURNS: Okay.

22 MS. MOSER: And, at Chippewa Falls it was 23 noise and traffic.

24 CHAIRMAN BURNS: But, the traffic, it 25 sounded like the traffic at all three sites --

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

192 1 MS. MOSER: Exactly.

2 CHAIRMAN BURNS: -- is more or less the 3 same?

4 MS. MOSER: Yes, at all three sites.

5 CHAIRMAN BURNS: What tips over into a 6 moderate impact in terms of noise? Is it the population 7 near to the -- you said -- I know you described that 8 whoever has their house nearest to that site is closer 9 than at the Janesville site or the proposed site.

10 Is it also a factor of population in those 11 areas?

12 MS. MOSER: Two main factors drove that.

13 One was, as you mentioned, how close the nearest 14 resident is because that would affect how audible the 15 noise is.

16 The second factor is what's the change in 17 noise? So, the amount of noise would be similar across 18 all three sites, but because at the alternative sites, 19 the background noise is less. The delta, the change in 20 noise would be more noticeable.

21 CHAIRMAN BURNS: And, is this noise 22 primarily during the construction period or demolition 23 period or is it normal operations?

24 MS. MOSER: Primarily during construction 25 and decommissioning.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

193 1 CHAIRMAN BURNS: Okay. All right, thank 2 you very much.

3 Commissioner Svinicki?

4 COMMISSIONER SVINICKI: May I testify, Mr.

5 Chairman, that both Chippewa Falls and Stevens Point and 6 Janesville are very lovely locations. And, just as 7 someone who will be traveling to Wisconsin next week, 8 I would commend to you that the State of Wisconsin has 9 a really impressive state park and trail system.

10 And, to Commissioner Ostendorff, for those 11 of us into cycling, distance cycling, Wisconsin has some 12 of the earliest rails to trails conversions that are 13 paved and really extensive. Some of them go through old 14 railroad tunnels.

15 Now, I did note that the Applicant's photos 16 of site characterizations showed everyone bundled up 17 and shivering in the cold. The staff's visit in July, 18 those were lovely photos that tell you the beauty, the 19 natural beauty, of the State of Wisconsin and the 20 Janesville area.

21 This is the environmental panel, so this is 22 all germane to our discussion here.

23 I do thank everyone for their presentations 24 and for all of their hard work that is underlying these 25 evaluations that have been done.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

194 1 To the staff, interestingly, I came at your 2 elective choice to do an EIS from the complete opposite 3 perspective of a question that the Chairman asked you.

4 An EIS was not strictly required here and given that, 5 one can always elect to do more because there's never 6 anyone who's going to prohibit you from doing the EIS 7 versus the environmental assessment.

8 How does the staff establish a system of 9 discriminating elements that you don't always default 10 to doing something, doing the EIS, the more involved 11 process? It does increase the resource investment and, 12 you know, has the potential to increase the time 13 duration of the review process as a whole, depending on 14 how the safety review is proceeding in parallel.

15 You know, how does the -- what would be 16 backstops when the staff would say yes, an environmental 17 assessment is indeed the appropriate thing to do if you 18 have the elective choice?

19 MS. MARSHALL: One of our points of 20 consideration was how well the staff understood the 21 impacts before performing the assessment. Because 22 this was a first-of-a-kind application for this 23 technology, the staff was not certain with what the 24 outcome of the assessment would be.

25 If we had performed an environmental NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

195 1 assessment and produced a finding, we would have had to 2 do the Environmental Impact Statement following the 3 assessment. So, that would have increased the time 4 line.

5 We also considered what actions we would 6 take which included public involvement even in an 7 environmental assessment and the time lines for either 8 an EA or an EIS came out very similar.

9 COMMISSIONER SVINICKI: That is an 10 important point and I appreciate you mentioning it that 11 an EA can lead to an EIS, so it is not necessarily an 12 either or. You may end up doing the Environmental 13 Impact Statement even if you begin with the 14 environmental assessment process.

15 So, thank you for the answer on that.

16 Again, the Applicant has discussed the fact 17 that they have a policy of transparency and outreach.

18 They touched on that in the overview and they touched 19 on it here in this panel with their testimony.

20 I would ask the Applicant, could you 21 elaborate on your separate and distinct outreach and 22 just creating awareness of the proposed facility and 23 what it would do separate from the staff's outreach 24 under -- to Tribal entities under Tribal outreach for 25 the EIS? Could you discuss any specific outreach you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

196 1 did to the Potawatomi Tribe or to the Ho-chunk Nation 2 and what form that took? Did you make overtures of your 3 own as the Applicant?

4 MS. PITAS: We did. So, we sent letters to 5 all of the 13 Tribes that I mentioned in my presentation.

6 And then, when we failed to receive responses from the 7 majority of them, actually made phone calls and, in most 8 cases, left voice mail messages with most of them.

9 COMMISSIONER SVINICKI: Okay.

10 MS. PITAS: And maybe even all of them. I 11 think probably all of them.

12 COMMISSIONER SVINICKI: Okay, thank you.

13 And, I'll just close by just saying, Jane, 14 you should go to Janesville. Did you go on the trip to 15 Janesville? If there was a Kristinesville, I would 16 definitely go.

17 MS. MARSHALL: I really wanted to go during 18 the --

19 COMMISSIONER SVINICKI: Oh, and he should 20 go to Stevens Point.

21 CHAIRMAN BURNS: They spell it 22 differently.

23 MS. MARSHALL: But no, I do hope to go in 24 the future.

25 COMMISSIONER SVINICKI: Okay. All right, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

197 1 thank you.

2 Thank you, Mr. Chairman.

3 CHAIRMAN BURNS: Thank you, Commissioner.

4 Commissioner Ostendorff?

5 COMMISSIONER OSTENDORFF: Well, since 6 we're still on the travelogue, I think Commissioner 7 Svinicki and I share a common experience every -- twice 8 a day, every day, as we drive from Northern Virginia into 9 the NRC via the American Legion Bridge listening to the 10 WTOP Traffic on the Eights or looking at the Waze display 11 on our iPhones, is it a fair statement that the traffic 12 in Janesville is less than in this area?

13 COMMISSIONER SVINICKI: It is, but I 14 appreciate that the staff has looked at not replicating 15 the Washington traffic in Janesville, which I don't 16 think any Janesvillian would appreciate.

17 COMMISSIONER OSTENDORFF: Good, thank 18 you.

19 I thought that was the case, but I 20 appreciate your clarification.

21 So, let me turn to the Applicant and I'm 22 going to ask Katrina a question on outreach as well.

23 And, it really gets into the unique nature of this 24 facility.

25 Certainly, Wisconsin's had experience with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

198 1 the Kewaunee Nuclear Power Plant and Point Beach 2 commercial power reactors. But here, we're talking 3 about, you know, deuterium bombarding tritium and 4 generating 14 MeV and, you know, neutrons and the whole 5 nuclear physics chain. And, the source term is very 6 different from commercial power reactors.

7 What can you tell us about the 8 understanding from your perspective with the SHINE 9 organization of the local community's appreciation for 10 what this is and what it's not compared to a commercial 11 power reactor? Does that make sense to you?

12 MS. PITAS: It does. And, it's a 13 difficult question to answer because I think there is 14 a wide range of understanding within the community. I 15 think the community especially appreciates the global 16 impact of the product, medical isotopes, in particular.

17 We've done our best to develop materials 18 that are simple enough that they increase the 19 understanding of someone without an expert level 20 understanding of nuclear processes and work hard to 21 bring those to our outreach meetings with the community.

22 So, we have posters, brochures.

23 In terms of understanding maybe the hazards 24 of the facility --

25 COMMISSIONER OSTENDORFF: Well, I think on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

199 1 your slides and the overview panel earlier today talks 2 about the source term being a factor of hundreds less 3 than for existing isotope production reactors 4 elsewhere.

5 So, looking at the relative scale of the 6 radiological source, do people understand that?

7 MS. PITAS: Yes, so I think so. It's one 8 of the key talking points that we use with the public 9 is in comparison to current production methods, the 10 amount of radioactivity produced per useful medical 11 isotope is hundreds of times less than -- yes, people 12 see that as a major benefit and a step forward for global 13 medical isotope production.

14 COMMISSIONER OSTENDORFF: Okay. Let me 15 stay with the Applicant for a separate question.

16 You know, our staff talked about the 17 complementary environmental impact statement work 18 between the NRC staff and the Department of Energy. As 19 far as the SHINE organization's concerned, did you see 20 a fairly consistent approach or did you see evidence 21 that different approaches between NRC type questions 22 and Department of Energy questions or how would you 23 characterize that experience?

24 MS. PITAS: I'm not sure I know. I'm not 25 very -- yes, go ahead, we'll call Greg Piefer to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

200 1 stand.

2 MR. PIEFER: So, Greg Piefer, still under 3 oath.

4 I think, you know, DOE largely let the NRC 5 process drive the show here and I think the NRC process 6 was very thorough. I assume there were some 7 negotiations behind the scenes in terms of making sure 8 DOE specific assessments were included in the NRC 9 process.

10 But, you know, I think it worked out pretty 11 well in this case and I think the NRC EIS time line was 12 within sort of the Construction Permit Safety Review 13 time line and so, it didn't add any time.

14 And, you know, the DOE EIS process who knows 15 what would have happened if they had chosen to do an EIS.

16 And so, I think, you know, ultimately, it worked out well 17 in this case.

18 COMMISSIONER OSTENDORFF: Okay, thank 19 you.

20 My final comment relates to the NRC staff 21 and goes to Michelle. Your comments and the Chairman's 22 comments on the alternative technologies, I appreciate 23 it.

24 It seems like the staff has exercised a very 25 commonsense approach. If there's not something there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

201 1 to evaluate then we shouldn't evaluate it. And so, it 2 looks like you all made a judgment call that there was 3 not sufficient evidence to look at some of these other 4 alternative technologies, so I just wanted to comment 5 favorably on the approach being taken.

6 Thank you. Thank you all.

7 CHAIRMAN BURNS: Thank you, Commissioner.

8 Commissioner Baran?

9 COMMISSIONER BARAN: Thanks.

10 Michelle, the staff's answer to 11 pre-hearing question 53 stated that it took climate 12 change into account when examining impacts to the 13 affected resources. The staff explained that it looked 14 at annual mean temperature increases and the increase 15 in the frequency, duration and intensity of droughts.

16 I really appreciate that you did that, that 17 the staff did that analysis. I think we should be 18 factoring in climate change impacts into our 19 environmental reviews more often. So, I commend you 20 all for doing that.

21 Can you tell us a little bit more about what 22 you did and how you did it?

23 MS. MOSER: Certainly. In Section 4.2 of 24 the EIS is where we analyzed emissions that could 25 potentially contribute to climate change. And, in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

202 1 Section 4.13, we conducted a cumulative impacts 2 analysis where we looked at what the overlapping impacts 3 could be from climate change on the environmental 4 resources that could also be affected by the proposed 5 SHINE facility.

6 COMMISSIONER BARAN: Thank you.

7 I also wanted to follow up on Commissioner 8 Svinicki's question about greater than Class C waste 9 that she asked earlier.

10 In response to that question, SHINE, you 11 noted that under the American Medical Isotope 12 Production Act, DOE would take title to and dispose of 13 any radioactive waste without a disposal path.

14 My question is, have you had any 15 discussions with DOE about how this program would work?

16 Are they committing to physically take possession of the 17 waste or make arrangements to store it or dispose of it 18 at another location within a certain time frame?

19 MS. PITAS: We'd like to call Vann Bynum to 20 the stand to talk about that.

21 CHAIRMAN BURNS: And, again, state your 22 name and confirm that you've been put under oath.

23 MR. BYNUM: My name's Vann Bynum and I did 24 take the oath this morning.

25 COMMISSIONER BURNS: Okay.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

203 1 MR. BYNUM: We've had a number of 2 discussions with DOE both at NNSA side and the EM side 3 for the lease and take back program. They've provided 4 us a draft contract template for the take back and we're 5 expecting a revised draft coming in January when the 6 program's supposed to be stood up. So, there's been 7 extensive discussions with them.

8 COMMISSIONER BARAN: Okay. And is this a 9 matter of them taking formal title to the waste or are 10 they physically going to take it off your hands somehow?

11 MR. BYNUM: Physically take it off our 12 hands.

13 COMMISSIONER BARAN: Okay. So, when you 14 all kind of are looking at how long you would expect to 15 potentially need to store it onsite, you're factoring 16 in that DOE is committing to actually take it offsite 17 for you?

18 MR. BYNUM: Yes.

19 COMMISSIONER BARAN: Yes? And it's a 20 relatively short time frame?

21 MR. BYNUM: We hope.

22 COMMISSIONER BARAN: You hope? Okay.

23 Fair enough.

24 That's all I have. Thank you.

25 MR. BYNUM: Thank you.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

204 1 COMMISSIONER BARAN: Thank you, Mr.

2 Chairman.

3 CHAIRMAN BURNS: Well, thanks --

4 COMMISSIONER BARAN: I should just note, I 5 don't have any tourism related questions. At some 6 point on this panel, I'm like, wow, when did I join the 7 Wisconsin Tourism Commission? But, I'll just --

8 COMMISSIONER SVINICKI: We should be so 9 lucky.

10 COMMISSIONER BARAN: I'm from the 11 Chicagoland area. Wisconsin's lovely.

12 COMMISSIONER SVINICKI: So, you're from 13 Chicagoland and you've never vacationed in Wisconsin?

14 You are the only person from Illinois that on a nice 15 weekend is not up there clogging all the highways into 16 Wisconsin.

17 COMMISSIONER BARAN: I did not say that --

18 COMMISSIONER SVINICKI: And owning all the 19 prime real estate.

20 COMMISSIONER BARAN: I don't have any 21 prime real estate in Wisconsin. I have vacationed 22 there, I just wasn't, you know, like advocating 23 vacationing there in the same way.

24 CHAIRMAN BURNS: And, I engaged in some 25 other -- I told Commissioner Svinicki, I actually NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

205 1 represented staff in proceedings in Wisconsin on the La 2 Crosse reactor which is --

3 COMMISSIONER SVINICKI: And, I do recall 4 you said it was beautiful there.

5 CHAIRMAN BURNS: And, it was beautiful, 6 it's a gorgeous area.

7 So, we'll have travel brochures as you exit 8 today.

9 But, I want to thank the environmental 10 panel.

11 We're going to take about a five, ten minute 12 break here. Try to be back in about five or six minutes.

13 And then we'll have the closing presentations from both 14 the Applicant and from the staff.

15 And, for both the Applicant and the staff, 16 I would say if there is any clarification, before your 17 closing statement, if there's any clarification you 18 want to make to the presentations, that would be the 19 time. We can make time to do what you feel you're 20 prepared to do today.

21 And, with that, we'll, again, adjourn for 22 about ten minutes.

23 (Whereupon, the above-entitled matter went 24 off the record at 3:00 p.m.)

25 CHAIRMAN BURNS: Well, good afternoon NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

206 1 again. This is the closing portion of the hearing and 2 we'll start first with the Applicant and I think, Mr.

3 Piefer, you're going to do -- is there any other 4 supplement that you all wanted to do to your testimony 5 or --

6 MR. PIEFER: No, we have no additions --

7 CHAIRMAN BURNS: Okay.

8 MR. PIEFER: -- or changes.

9 CHAIRMAN BURNS: Then please proceed.

10 MR. PIEFER: Yes. So I have very little to 11 say at this point. I just wanted to thank you guys again 12 for your time, your consideration in this very important 13 matter.

14 I did want to offer thanks and commendation 15 to the staff for very transparent and straightforward 16 communications throughout this process. I think our 17 team has been very impressed and wanted to let you guys 18 know that. So thank you again for your time today and 19 really appreciate the consideration.

20 CHAIRMAN BURNS: Thank you. Mr. Dean, 21 you're on for the staff, but there may be some supplement 22 that the staff would like to make at this point?

23 MR. DEAN: Yes, thank you, Chairman. Yes, 24 this morning we had I think a few open questions, open 25 issues where we didn't either cleanly answer the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

207 1 question or maybe we left a question open, so we thought 2 it would be beneficial if Steve Lynch could provide you 3 responses to the five particular areas where we think 4 we needed to provide more clarification. So if you 5 don't mind, I'll have 6 Steve --

7 CHAIRMAN BURNS: Okay. Mr. Lynch, please 8 proceed.

9 MR. LYNCH: Yes, I'll run through these 10 very quickly. The first was with respect to the size 11 of aircraft that were analyzed for our review. Just 12 wanted to clarify that the staff examined -- there were 13 three main categories of aircraft that were broadly 14 military, small and large. And the analysis was 15 probabilistic on this looking at both those types of 16 aircraft that would land at the airport and those that 17 would be passing overhead in the corridors. So for this 18 analysis no matter whether the aircraft was landing at 19 the SHINE site, or at the airport across the street, or 20 overhead, if the probability was less than the 21 threshold, it was excluded from examination. The only 22 types of aircraft were two small aircraft, the 23 Challenger 605 and the Hawker 400, that SHINE analyzed 24 as being above the threshold and the facility has been 25 designed to withstand those aircraft impacts.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

208 1 The second issue we had identified was the 2 natural gas pipelines. To clarify, yes, the staff did 3 look at natural gas pipelines near the SHINE facility 4 and at the SHINE facility. These are provided in 5 figures both in the staff's SER and SHINE's PSAR in 6 chapter 2. There's also a table in SHINE's PSAR in 7 chapter 2 that gives distances and sizes of the natural 8 gas pipelines surrounding the facility. While the 9 sizes of the pipelines are proprietary information, the 10 distances are given.

11 The next issue I had, I wanted to clarify 12 some statements that we made with respect to 13 differentiating between the irradiation facility and 14 the production facility. In our Interim Staff Guidance 15 we had initially assumed that the irradiation facility 16 or an irradiation-like facility would be dependent 17 functionally on the production facility in order to 18 perform and make medical radioisotopes. So that is why 19 in our guidance we'd initially thought that a single 20 production facility license could be issued for the 21 entire facility.

22 After reviewing SHINE's application we 23 came to the understanding that the irradiation facility 24 and radioisotope production facility could operate 25 separately and independently, meaning SHINE can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

209 1 irradiate as much uranium as they want at the 2 irradiation facility without impacting the function of 3 the production facility. They don't even need to be in 4 the same building. They could be in different states.

5 So because of that we understood that the irradiation 6 facility is licensed as irradiation units and the 7 production facility is separately licensed as the 8 production facility.

9 The next issue I wanted to address were 10 distinguishing between commitments and conditions.

11 Items that are identified in SHINE's Corrective Action 12 Program that they provided to the staff and that the 13 staff determined could be reasonably left for later 14 consideration in the final safety analysis report, 15 those represent the regulatory commitments that SHINE 16 has made. The conditions on the other hand are issues 17 that the staff would like more information on during 18 construction. And we'd like to emphasize that the 19 conditions, unlike the commitments, cannot be changed 20 without prior NRC approval.

21 And then the final item that I would like 22 to provide clarification on were the differences 23 between the soluble uranium intake concentrations of 10 24 milligrams per week for occupational limits and 30 25 milligrams for accident conditions. So that's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

210 1 essentially it. We think these two limits are 2 compatible and that for an occupational worker if you're 3 receiving 10 milligrams per week per the regulations you 4 could receive up to 520 milligrams of soluble uranium 5 and still be in line with the regulations each year.

6 The 30-milligram intake in contrast to that 7 is assuming an acute exposure from a highly unlikely 8 accident, meaning this is an event that has a 10 to the 9 minus 5 likelihood of occurring over a 24-hour period.

10 So we think the differences between routine 11 occupational exposure versus an acute accident exposure 12 explained the differences and that they are consistent 13 with one another.

14 And those are all the comments that I have 15 to make.

16 CHAIRMAN BURNS: Okay. Mr. Dean, proceed 17 with your --

18 MR. DEAN: Thank you. And in light of the 19 previous discussion, I have been to Williamsburg. I 20 don't know if that counts --

21 (Laughter) 22 MR. DEAN: Kristinesville and Barantown.

23 I don't know.

24 The staff's review of the SHINE 25 construction permit application supports the national NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

211 1 policy objectives of establishing a domestic supply of 2 molybdenum-99. The SHINE review presented a number of 3 unique technical and licensing considerations for the 4 staff. The timely completion of this review required 5 the expertise, cooperation and dedication of staff 6 throughout the agency. The thoroughness of the staff's 7 evaluation is reflected by the Advisory Committee on 8 Reactor Safeguards' recommendation to issue the 9 construction permit.

10 I'd particularly like to commend our staff 11 given the fact that this was a first of a kind, unique 12 review and the fact that they were able to accomplish 13 it in a short time frame, within two years. And I 14 particularly want to commend the individual on my right, 15 Mr. Lynch, who has been the project manager for the 16 SHINE. He has just done a tremendous job in terms of 17 overseeing that. So I wanted to take the opportunity 18 to do that at this time.

19 The staff evaluated SHINE's preliminary 20 design to ensure sufficiency of information to provide 21 reasonable assurance that the final design will conform 22 to the design-bases. The staff considered the 23 preliminary analysis and evaluation of the design and 24 performance of structures, systems and components of 25 the SHINE facility with the objective of assessing the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

212 1 risk to public health and safety resulting from 2 operation of the facility.

3 Structures, systems and components were 4 evaluated to ensure that they would adequately provide 5 for the prevention of accidents and the mitigation of 6 consequences of accidents. And the staff also 7 considered the potential environmental impact of the 8 facility in accordance with the National Environmental 9 Policy Act.

10 The objective of the staff's evaluation was 11 to assess the sufficiency of information contained in 12 the PSAR for the issuance of a construction permit. As 13 such, the staff's evaluation of the preliminary design 14 and analysis of the SHINE facility does not constitute 15 approval of the safety of any design features or 16 specifications. Such approval will be made following 17 the evaluation of the final design of the facility as 18 described in the FSAR as part of SHINE's operating 19 license application. An in-depth evaluation of the 20 SHINE design will be performed following the staff's 21 receipt of SHINE's FSAR.

22 Based on the findings of the staff's review 23 as documented in the Safety Evaluation Report and the 24 final EIS, Environmental Impact Statement, and in 25 accordance with 10 CFR Parts 50 and 51, the staff NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

213 1 concludes that there is sufficient information for the 2 Commission to issue the subject construction permit to 3 SHINE. And that concludes my closing remarks.

4 CHAIRMAN BURNS: Thank you. And for 5 closing, any closing questions or remarks, we'll start 6 with Commissioner Svinicki.

7 COMMISSIONER SVINICKI: Well, again I want 8 to thank everyone for their presentations. And, Bill, 9 I appreciate that you've been to Williamsburg. And all 10 I have to say, at the risk of sounding like John Belushi 11 in Animal House, if there's a Barantown, I got one thing 12 to say: Road trip. I think we should move immediately 13 that the Commission make a road trip there.

14 On a more serious note, I think we don't get 15 to this stage in the licensing process or the issuance 16 of a construction permit without tremendous dedication 17 to the task by both the Applicant and the staff, and 18 tremendous professionalism I think was displayed, not 19 only today, but was evident in the description in the 20 engagements both with external parties and with each 21 other that we've heard about in the answers to the 22 questions throughout the mandatory hearing here today.

23 Again, I'd just note for anyone listening 24 unfamiliar with this process, this hearing and the Q &

25 A we conducted is not the totality of the record. There NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

214 1 is tremendous analytical record that backs up all of the 2 responses that we heard today. It is voluminous. And 3 then there were prehearing materials and testimony that 4 was provided to all members of the Commission, which we 5 began with a presumption today that the Commission 6 already knew that, but that was hundreds of pages I think 7 in and of itself.

8 So I thank again, especially looking 9 inwardly to the NRC, all of the NRC staff that 10 contributed. And that's everyone, both the technical 11 staff, the legal staff, but all those in support roles 12 that make it possible to conduct a hearing like this.

13 And I think that the Commission is well-served to make 14 a very efficient deliberation and hopefully a timely 15 decision on this matter. Thank you, Mr. Chairman.

16 CHAIRMAN BURNS: Thank you. Commissioner 17 Ostendorff?

18 COMMISSIONER OSTENDORFF: Thank you. I 19 have no questions. My comments are very similar to 20 Commissioner Svinicki's for SHINE and the organization.

21 I appreciate the professionalism and the attention to 22 detail that you've obviously provided in your 23 application.

24 To the NRC staff, I am pleased to be part 25 of an organization looking at a new technology and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

215 1 looking at things that are different from what we've 2 done in the past. And so I think that aspect that's been 3 highlighted by many at this table today is very 4 significant. And being able to take a good look at what 5 our regulations require, what's the spirit and the 6 intent and how to apply those to areas where perhaps all 7 the Is may not be dotted and all the Ts may not be 8 crossed, but in a way to execute our responsibilities 9 in a common sense approach when there may not be complete 10 word-for-word coverage that's identical to what we've 11 dealt with in the past. So that's I think a significant 12 accomplishment.

13 And I do appreciate the work of all the 14 staff, as Commissioner Svinicki noted, across the 15 entire agency. Well done.

16 CHAIRMAN BURNS: Thank you. Commission 17 Baran?

18 COMMISSIONER BARAN: Well, just briefly I 19 want to join my colleagues in thanking the NRC staff and 20 SHINE for all of your hard work throughout the review 21 of this application. We appreciate the significant 22 amount of preparation that goes into one of these 23 mandatory hearings, so thank you for all that work.

24 I think today's hearing's been valuable.

25 It's a valuable part of the process and I thank everyone NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

216 1 for their efforts.

2 CHAIRMAN BURNS: Thank you. And I'll 3 conclude by echoing the comments of my colleagues. As 4 well I appreciate the effort, both the Applicant SHINE, 5 as well as the staff have put into it. And as 6 Commissioner Svinicki said, we're really just doing a 7 sampling here today. There's a much deeper record on 8 which the decision making will be based as we consider 9 whether or not to allow issuance of a construction 10 permit under the Atomic Energy Act for this facility.

11 But it reflects a lot of hard work and thoughtful work 12 by both the Applicant and the staff.

13 I also want to conclude by thanking behind 14 the scenes support we get as well from the Office of 15 Commission Appellate Adjudication and the Office of the 16 Secretary that assure the smooth flow of these 17 proceedings.

18 And with that, I will mention two other 19 things, and hopefully not be considered Scrooge in 20 announcing them. And that is that you may expect -- the 21 Applicant and staff may expect the Secretary to issue 22 an order with post-hearing questions by about December 23 22nd. And the deadline for the responses will likely 24 be December 30th. So you can do it before the new year.

25 And then also obviously we've had a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

217 1 transcript made of the proceedings here today and the 2 transcript will be provided by the Secretary with an 3 order requesting proposed corrections. That order 4 will probably be issued around December 21st with a 5 one-week deadline for transcript corrections on 6 December 28th.

7 Part of the reason for that is the 8 Commission I think in its -- in my experience, both as 9 general counsel and now returning to the agency in the 10 last year with my colleagues presiding over these 11 proceedings is the Commission is dedicated to making 12 decisions in a timely fashion in these proceedings.

13 And in saying that, I do expect us to issue a final 14 decision promptly with due regard to the complexity of 15 the issues before us.

16 Again, thank you, everyone. And we are 17 adjourned.

18 (Whereupon, the above-entitled matter went 19 off the record at 3:23 p.m.)

20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

218 1

2 3

4 5

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION 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 (Adopting Proposed Transcript Corrections, Admitting Post-Hearing Exhibits, and Closing the Record of the Proceeding) 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 Brian Newell ]

Office of the Secretary of the Commission Dated at Rockville, Maryland this 14th day of January, 2016