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| issue date = 12/11/2015
| issue date = 12/11/2015
| title = Revised NRC Exhibit List and Witness List
| title = Revised NRC Exhibit List and Witness List
| author name = Kanatas C E
| author name = Kanatas C
| author affiliation = NRC/OGC
| author affiliation = NRC/OGC
| addressee name =  
| addressee name =  
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{{#Wiki_filter:December 11, 2015 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of ) ) SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP ) (Medical Radioisotope Production Facility) ) ) REVISED NRC STAFF EXHIBIT LIST AND WITNESS LIST   The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its revised exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). The exhibit list is being revised to reflect the filing of a revision to Exhibit NRC-012, Staff Presentation Slides - Safety Panel 2, designated as NRC-012-R. The revision is necessary to correct the fifth bullet on Slide 6, Safety Concept, of Exhibit NRC-012, which states, "Emergency planning zone is the site boundary."  The modified bullet states, "Emergency planning zone could be the operational boundary."  This modification is to accurately reflect, as stated in the Staff's Safety Evaluation Report, that (1) an Emergency Planning Zone (EPZ) need not be established before issuance of a construction permit and (2) consistent with the guidance in ANSI/ANS-15.16, an acceptable EPZ could be the operational boundary of the SHINE facility. Staff counsel informed Applicant's counsel of the revision described above and Applicant's counsel has no objection. The Staff also hereby files a revised witness list for the mandatory hearing on SHINE's construction permit application. The witness list is being revised to correct a misspelling of a name (Down should be Downs) and to add one additional witness (John Adams). Staff counsel informed Applicant's counsel of the revisions to the witness list and Applicant's counsel has no objection.       Respectfully submitted, /Signed (electronically) by/ Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov   Executed in accord with 10 CFR 2.304(d) Mitzi A. Young       Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015 Staff Exhibits for SHINE Mandatory Hearing Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-001 Mirela Gavrilas & Jane Marshall SECY-15-0130, Staff Statement in Support of the Uncontested Hearing for Issuance of Construction Permit for the SHINE Medical Technologies, Inc. Medical Radioisotope Production Facility (October 22, 2015), ADAMS Accession No. ML15272A004. NRC-002 Mirela Gavrilas Draft Construction Permit for SHINE Medical Technologies, Inc. (December 8, 2015). NRC-003 Jane Marshall Draft Record of Decision for SHINE Medical Technologies, Inc. Construction Permit Application (November 17, 2015), ADAMS Accession No. ML15272A019. NRC-004-R Mirela Gavrilas & Jane Marshall NRC Staff Responses to Commission Pre-Hearing Questions, (originally filed on November 24, 2015), (revised December 8, 2015) NRC-005 Mirela Gavrilas & Jane Marshall NON-PUBLIC - NRC Staff Responses to Commission Pre-Hearing Questions, Non-public (filed on November 24, 2015), ADAMS Accession No. ML15328A545. NRC-006A Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Cover Letter and General and Financial Information (March 26, 2013), ADAMS Accession No. ML13088A192. NRC-006B Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Updated General Information (September 16, 2015), ADAMS Accession No. ML15259A272. NRC-006C Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Safety Analysis Report (PSAR), beginning through Chapter 2, Figure 2.3-36 (August 27, 2015), ADAMS Accession Nos. ML15258A389, ML15258A369, ML15258A370, ML15258A390, ML15258A391, ML15258A392, ML15258A393. NRC-006D Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.4-1 through Figure 2.4-11 (August 27, 2015), ADAMS Accession No. ML15258A395. NRC-006E Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-1 through Figure 2.5-6 (August 27, 2015), ADAMS Accession No. ML15258A396.
{{#Wiki_filter:December 11, 2015 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of                                   )
Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-006F Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-7 through Figure 2.5-23 (August 27, 2015), ADAMS Accession No. ML15258A398. NRC-006G Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 3 through Chapter 18 (August 27, 2015), ADAMS Accession Nos. ML15258A371, ML15258A372, ML15258A373, ML15258A374, ML15258A375, ML15258A376, ML15258A377, ML15258A378. ML15258A379, ML15258A380, ML15258A381, ML15258A382, ML15258A383, ML15258A384, ML15258A385, ML15258A386, ML15258A387, ML15258A388, ML15258A399, ML15258A400, ML15258A402, ML15258A403, ML15258A404, ML15258A405, ML15258A406, ML15258A407, ML15258A408, ML15258A409, ML15258A410, ML15258A411. NRC-006H Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, beginning through end of text and Chapter 19, Figure 19.2.1-1 through Figure 19.2.3-1 (August 27, 2015), ADAMS Accession Nos.
                                                    )
ML15258A419, ML15258A412, ML15258A413, ML15258A414, ML15258A415, ML15258A416, ML15258A417, ML15258A418, ML15258A420. NRC-006J1 Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.3.1-1 through Figure 19.3.1-6 (August 27, 2015), ADAMS Accession No. ML15258A421. NRC-006K Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19 Figure 19.3.1-7 through Figure 19.3.1-9 (August 27, 2015), ADAMS Accession No. ML15258A422. NRC-006L Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.3.2-1 through Figure 19.3.2-36 (August 27, 2015), ADAMS Accession No. ML15258A423. NRC-006M Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.3.3-1 through Figure 19.3.3-7 (August 27, 2015), ADAMS Accession No. ML15258A424.                                                 1 The letter "I" was skipped to avoid potential confusion with the number "1."
SHINE MEDICAL TECHNOLOGIES, INC.                   ) Docket No. M-50-608-CP
Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-006N Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, Chapter 19 Figure 19.3.4-1 to Chapter 19 Figure 19.3.4-8 (August 27, 2015), ADAMS Accession No. ML15258A426. NRC-006O Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19 Figure 19.3.5-1 through Figure 19.3.8-2 (August 27, 2015), ADAMS Accession No. ML15258A427. NRC-006P Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19 Figure 19.4.1-1 through Figure 19.4.13-1 (August 27, 2015), ADAMS Accession No. ML15258A428. NRC-006Q Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.5.2-1 through Figure 19.5.2-5 (August 27, 2015), ADAMS Accession No. ML15258A429. NRC-006R Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.5.2-6 through Figure 19.5.2-9 (August 27, 2015), ADAMS Accession No. ML15258A430. NRC-007A Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - General and Financial Information, Non-public (March 26, 2013), ADAMS Accession No. ML13088A193. NRC-007B Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], beginning through Chapter 3 (August 27, 2015), ADAMS Accession Nos. ML15258A332, ML15258A322, ML15258A323, ML15258A324, ML15258A333, ML15258A334. NRC-007C Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR],and Environmental Report, [PSAR] Chapter 4 through Chapter 19 (August 27, 2015), ADAMS Accession Nos. ML15258A325, ML15258A326, ML15258A327, ML15258A328, ML15258A329, ML15258A330, ML15258A331, ML15258A335, ML15258A336, ML15258A337, ML15258A338, ML15258A339, ML15258A340, ML15258A341, ML15258A342, ML15258A343.
                                                    )
Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-007D Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Emergency Plan (September 25, 2013), ADAMS Accession No. ML13269A379. NRC-008 Mirela Gavrilas Safety Evaluation Report related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medial Radioisotope Production Facility, (revised December 8, 2015) NRC-009 Jane Marshall NUREG-2183, Final Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (October 16, 2015), ADAMS Accession No. ML15288A046. NRC-010 Mirela Gavrilas & Jane Marshall Staff Presentation Slides - Overview (December 8, 2015). NRC-011 Mirela Gavrilas Staff Presentation Slides - Safety Panel 1 (December 8, 2015). NRC-012-R Mirela Gavrilas Staff Presentation Slides - Safety Panel 2 (December 8, 2015, Corrected Exhibit Filed December 11, 2015). NRC-013 Jane Marshall Staff Presentation Slides - Environmental Panel (December 8, 2015).
(Medical Radioisotope Production Facility)         )
NRC Staff Witness List for SHINE Construction Permit Hearing Safety Witness Staff Office Alexander Adams Office of Nuclear Reactor Regulation John Adams Office of Nuclear Reactor Regulation Mary Adams Office of Nuclear Material Safety and Safeguards Stephen Alexander Information Systems Laboratories David Back Information Systems Laboratories Marissa Bailey Office of Nuclear Material Safety and Safeguards Daniel Barss Office of Nuclear Security and Incident Response Thomas Boyle Office of Regulatory Research Gregory Chapman Office of Nuclear Material Safety and Safeguards Jorge Cintron-Rivera Office of Nuclear Material Safety and Safeguards William Dean Office of Nuclear Reactor Regulation James Downs Office of Nuclear Material Safety and Safeguards Thomas Essig Information Systems Laboratories Mirela Gavrilas Office of Nuclear Reactor Regulation Mary Gitnick Information Systems Laboratories James Hammelman Office of Nuclear Material Safety and Safeguards Shawn Harwell Office of Nuclear Reactor Regulation Christopher Heysel Information Systems Laboratories Gregory Hofer Information Systems Laboratories Anthony Huffert Office of Regulatory Research Steven Lynch Office of Nuclear Reactor Regulation Stephen Marschke Information Systems Laboratories James Mcllvaine Information Systems Laboratories Diane Mlynarczyk Information Systems Laboratories Kevin Morrissey Office of Nuclear Material Safety and Safeguards Thomas Pham Office of Nuclear Material Safety and Safeguards Paul Prescott Office of New Reactors Michael Salay Office of Regulatory Research Alexander Sapountzis Office of Nuclear Security and Incident Response Raymond Skarda Office of Regulatory Research Soly Soto-Lugo Office of Nuclear Material Safety and Safeguards Joseph Staudenmeier Office of Regulatory Research Christopher Tripp Office of Nuclear Material Safety and Safeguards Glenn Tuttle Office of Nuclear Material Safety and Safeguards Carl Weber Office of New Reactors Abraham Weitzberg Information Systems Laboratories Environmental Witness Staff Office Kevin Folk Office of Nuclear Reactor Regulation Robert Hoffman Office of Nuclear Reactor Regulation Jane Marshall Office of Nuclear Reactor Regulation Nancy Martinez Office of Nuclear Reactor Regulation Michelle Moser Office of Nuclear Reactor Regulation Jeffrey Rikhoff Office of Nuclear Reactor Regulation William Rautzen Office of Nuclear Reactor Regulation David Wrona Office of Nuclear Reactor Regulation UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of ) ) SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP ) (Medical Radioisotope Production Facility) ) )   CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing "NRC STAFF REVISED EXHIBIT LIST AND WITNESS LIST," dated December 11, 2015, and Exhibit NRC-012-R have been served upon the Electronic Information Exchange, the NRC's E-Filing System, in the above-captioned proceeding, this 11th day of December, 2015.   /Signed (electronically) by/       Catherine E. Kanatas       Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015 December 11, 2015 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of ) ) SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP ) (Medical Radioisotope Production Facility) ) ) REVISED NRC STAFF EXHIBIT LIST AND WITNESS LIST   The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its revised exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). The exhibit list is being revised to reflect the filing of a revision to Exhibit NRC-012, Staff Presentation Slides - Safety Panel 2, designated as NRC-012-R. The revision is necessary to correct the fifth bullet on Slide 6, Safety Concept, of Exhibit NRC-012, which states, "Emergency planning zone is the site boundary."  The modified bullet states, "Emergency planning zone could be the operational boundary."  This modification is to accurately reflect, as stated in the Staff's Safety Evaluation Report, that (1) an Emergency Planning Zone (EPZ) need not be established before issuance of a construction permit and (2) consistent with the guidance in ANSI/ANS-15.16, an acceptable EPZ could be the operational boundary of the SHINE facility. Staff counsel informed Applicant's counsel of the revision described above and Applicant's counsel has no objection. The Staff also hereby files a revised witness list for the mandatory hearing on SHINE's construction permit application. The witness list is being revised to correct a misspelling of a name (Down should be Downs) and to add one additional witness (John Adams). Staff counsel informed Applicant's counsel of the revisions to the witness list and Applicant's counsel has no objection.       Respectfully submitted, /Signed (electronically) by/ Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov   Executed in accord with 10 CFR 2.304(d) Mitzi A. Young       Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015 Staff Exhibits for SHINE Mandatory Hearing Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-001 Mirela Gavrilas & Jane Marshall SECY-15-0130, Staff Statement in Support of the Uncontested Hearing for Issuance of Construction Permit for the SHINE Medical Technologies, Inc. Medical Radioisotope Production Facility (October 22, 2015), ADAMS Accession No. ML15272A004. NRC-002 Mirela Gavrilas Draft Construction Permit for SHINE Medical Technologies, Inc. (December 8, 2015). NRC-003 Jane Marshall Draft Record of Decision for SHINE Medical Technologies, Inc. Construction Permit Application (November 17, 2015), ADAMS Accession No. ML15272A019. NRC-004-R Mirela Gavrilas & Jane Marshall NRC Staff Responses to Commission Pre-Hearing Questions, (originally filed on November 24, 2015), (revised December 8, 2015) NRC-005 Mirela Gavrilas & Jane Marshall NON-PUBLIC - NRC Staff Responses to Commission Pre-Hearing Questions, Non-public (filed on November 24, 2015), ADAMS Accession No. ML15328A545. NRC-006A Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Cover Letter and General and Financial Information (March 26, 2013), ADAMS Accession No. ML13088A192. NRC-006B Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Updated General Information (September 16, 2015), ADAMS Accession No. ML15259A272. NRC-006C Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Safety Analysis Report (PSAR), beginning through Chapter 2, Figure 2.3-36 (August 27, 2015), ADAMS Accession Nos. ML15258A389, ML15258A369, ML15258A370, ML15258A390, ML15258A391, ML15258A392, ML15258A393. NRC-006D Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.4-1 through Figure 2.4-11 (August 27, 2015), ADAMS Accession No. ML15258A395. NRC-006E Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-1 through Figure 2.5-6 (August 27, 2015), ADAMS Accession No. ML15258A396.
                                                    )
Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-006F Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-7 through Figure 2.5-23 (August 27, 2015), ADAMS Accession No. ML15258A398. NRC-006G Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 3 through Chapter 18 (August 27, 2015), ADAMS Accession Nos. ML15258A371, ML15258A372, ML15258A373, ML15258A374, ML15258A375, ML15258A376, ML15258A377, ML15258A378. ML15258A379, ML15258A380, ML15258A381, ML15258A382, ML15258A383, ML15258A384, ML15258A385, ML15258A386, ML15258A387, ML15258A388, ML15258A399, ML15258A400, ML15258A402, ML15258A403, ML15258A404, ML15258A405, ML15258A406, ML15258A407, ML15258A408, ML15258A409, ML15258A410, ML15258A411. NRC-006H Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, beginning through end of text and Chapter 19, Figure 19.2.1-1 through Figure 19.2.3-1 (August 27, 2015), ADAMS Accession Nos.
REVISED NRC STAFF EXHIBIT LIST AND WITNESS LIST The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its revised exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). The exhibit list is being revised to reflect the filing of a revision to Exhibit NRC-012, Staff Presentation Slides - Safety Panel 2, designated as NRC-012-R.
ML15258A419, ML15258A412, ML15258A413, ML15258A414, ML15258A415, ML15258A416, ML15258A417, ML15258A418, ML15258A420. NRC-006J1 Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.3.1-1 through Figure 19.3.1-6 (August 27, 2015), ADAMS Accession No. ML15258A421. NRC-006K Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19 Figure 19.3.1-7 through Figure 19.3.1-9 (August 27, 2015), ADAMS Accession No. ML15258A422. NRC-006L Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.3.2-1 through Figure 19.3.2-36 (August 27, 2015), ADAMS Accession No. ML15258A423. NRC-006M Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.3.3-1 through Figure 19.3.3-7 (August 27, 2015), ADAMS Accession No. ML15258A424.                                                 1 The letter "I" was skipped to avoid potential confusion with the number "1."
The revision is necessary to correct the fifth bullet on Slide 6, Safety Concept, of Exhibit NRC-012, which states, Emergency planning zone is the site boundary. The modified bullet states, Emergency planning zone could be the operational boundary. This modification is to accurately reflect, as stated in the Staffs Safety Evaluation Report, that (1) an Emergency Planning Zone (EPZ) need not be established before issuance of a construction permit and (2) consistent with the guidance in ANSI/ANS-15.16, an acceptable EPZ could be the operational boundary of the SHINE facility. Staff counsel informed Applicants counsel of the revision described above and Applicants counsel has no objection.
Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-006N Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, Chapter 19 Figure 19.3.4-1 to Chapter 19 Figure 19.3.4-8 (August 27, 2015), ADAMS Accession No. ML15258A426. NRC-006O Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19 Figure 19.3.5-1 through Figure 19.3.8-2 (August 27, 2015), ADAMS Accession No. ML15258A427. NRC-006P Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19 Figure 19.4.1-1 through Figure 19.4.13-1 (August 27, 2015), ADAMS Accession No. ML15258A428. NRC-006Q Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.5.2-1 through Figure 19.5.2-5 (August 27, 2015), ADAMS Accession No. ML15258A429. NRC-006R Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR] Chapter 19, Figure 19.5.2-6 through Figure 19.5.2-9 (August 27, 2015), ADAMS Accession No. ML15258A430. NRC-007A Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - General and Financial Information, Non-public (March 26, 2013), ADAMS Accession No. ML13088A193. NRC-007B Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], beginning through Chapter 3 (August 27, 2015), ADAMS Accession Nos. ML15258A332, ML15258A322, ML15258A323, ML15258A324, ML15258A333, ML15258A334. NRC-007C Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR],and Environmental Report, [PSAR] Chapter 4 through Chapter 19 (August 27, 2015), ADAMS Accession Nos. ML15258A325, ML15258A326, ML15258A327, ML15258A328, ML15258A329, ML15258A330, ML15258A331, ML15258A335, ML15258A336, ML15258A337, ML15258A338, ML15258A339, ML15258A340, ML15258A341, ML15258A342, ML15258A343.
The Staff also hereby files a revised witness list for the mandatory hearing on SHINEs construction permit application. The witness list is being revised to correct a misspelling of a name (Down should be Downs) and to add one additional witness (John Adams). Staff counsel informed Applicants counsel of the revisions to the witness list and Applicants counsel has no objection.
Exhibit Number Panel Number/Sponsoring Witness(es) Document Description/Title NRC-007D Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Emergency Plan (September 25, 2013), ADAMS Accession No. ML13269A379. NRC-008 Mirela Gavrilas Safety Evaluation Report related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medial Radioisotope Production Facility, (revised December 8, 2015) NRC-009 Jane Marshall NUREG-2183, Final Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (October 16, 2015), ADAMS Accession No. ML15288A046. NRC-010 Mirela Gavrilas & Jane Marshall Staff Presentation Slides - Overview (December 8, 2015). NRC-011 Mirela Gavrilas Staff Presentation Slides - Safety Panel 1 (December 8, 2015). NRC-012-R Mirela Gavrilas Staff Presentation Slides - Safety Panel 2 (December 8, 2015, Corrected Exhibit Filed December 11, 2015). NRC-013 Jane Marshall Staff Presentation Slides - Environmental Panel (December 8, 2015).
 
NRC Staff Witness List for SHINE Construction Permit Hearing Safety Witness Staff Office Alexander Adams Office of Nuclear Reactor Regulation John Adams Office of Nuclear Reactor Regulation Mary Adams Office of Nuclear Material Safety and Safeguards Stephen Alexander Information Systems Laboratories David Back Information Systems Laboratories Marissa Bailey Office of Nuclear Material Safety and Safeguards Daniel Barss Office of Nuclear Security and Incident Response Thomas Boyle Office of Regulatory Research Gregory Chapman Office of Nuclear Material Safety and Safeguards Jorge Cintron-Rivera Office of Nuclear Material Safety and Safeguards William Dean Office of Nuclear Reactor Regulation James Downs Office of Nuclear Material Safety and Safeguards Thomas Essig Information Systems Laboratories Mirela Gavrilas Office of Nuclear Reactor Regulation Mary Gitnick Information Systems Laboratories James Hammelman Office of Nuclear Material Safety and Safeguards Shawn Harwell Office of Nuclear Reactor Regulation Christopher Heysel Information Systems Laboratories Gregory Hofer Information Systems Laboratories Anthony Huffert Office of Regulatory Research Steven Lynch Office of Nuclear Reactor Regulation Stephen Marschke Information Systems Laboratories James Mcllvaine Information Systems Laboratories Diane Mlynarczyk Information Systems Laboratories Kevin Morrissey Office of Nuclear Material Safety and Safeguards Thomas Pham Office of Nuclear Material Safety and Safeguards Paul Prescott Office of New Reactors Michael Salay Office of Regulatory Research Alexander Sapountzis Office of Nuclear Security and Incident Response Raymond Skarda Office of Regulatory Research Soly Soto-Lugo Office of Nuclear Material Safety and Safeguards Joseph Staudenmeier Office of Regulatory Research Christopher Tripp Office of Nuclear Material Safety and Safeguards Glenn Tuttle Office of Nuclear Material Safety and Safeguards Carl Weber Office of New Reactors Abraham Weitzberg Information Systems Laboratories Environmental Witness Staff Office Kevin Folk Office of Nuclear Reactor Regulation Robert Hoffman Office of Nuclear Reactor Regulation Jane Marshall Office of Nuclear Reactor Regulation Nancy Martinez Office of Nuclear Reactor Regulation Michelle Moser Office of Nuclear Reactor Regulation Jeffrey Rikhoff Office of Nuclear Reactor Regulation William Rautzen Office of Nuclear Reactor Regulation David Wrona Office of Nuclear Reactor Regulation UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of ) ) SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP ) (Medical Radioisotope Production Facility) ) )   CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing "NRC STAFF REVISED EXHIBIT LIST AND WITNESS LIST," dated December 11, 2015, and Exhibit NRC-012-R have been served upon the Electronic Information Exchange, the NRC's E-Filing System, in the above-captioned proceeding, this 11th day of December, 2015.   /Signed (electronically) by/       Catherine E. Kanatas       Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015}}
Respectfully submitted,
                                /Signed (electronically) by/
Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Executed in accord with 10 CFR 2.304(d)
Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015
 
Staff Exhibits for SHINE Mandatory Hearing Panel Exhibit Number/Sponsoring                   Document Description/Title Number Witness(es)
NRC-001   Mirela Gavrilas &       SECY-15-0130, Staff Statement in Support of the Jane Marshall          Uncontested Hearing for Issuance of Construction Permit for the SHINE Medical Technologies, Inc.
Medical Radioisotope Production Facility (October 22, 2015), ADAMS Accession No. ML15272A004.
NRC-002   Mirela Gavrilas         Draft Construction Permit for SHINE Medical Technologies, Inc. (December 8, 2015).
NRC-003   Jane Marshall           Draft Record of Decision for SHINE Medical Technologies, Inc. Construction Permit Application (November 17, 2015), ADAMS Accession No. ML15272A019.
NRC-004-R Mirela Gavrilas &       NRC Staff Responses to Commission Pre-Hearing Jane Marshall          Questions, (originally filed on November 24, 2015),
(revised December 8, 2015)
NRC-005   Mirela Gavrilas &       NON-PUBLIC - NRC Staff Responses to Jane Marshall          Commission Pre-Hearing Questions, Non-public (filed on November 24, 2015), ADAMS Accession No. ML15328A545.
NRC-006A   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - Cover Letter and General and Financial Information (March 26, 2013), ADAMS Accession No. ML13088A192.
NRC-006B   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - Updated General Information (September 16, 2015), ADAMS Accession No. ML15259A272.
NRC-006C   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Safety Analysis Report (PSAR), beginning through Chapter 2, Figure 2.3-36 (August 27, 2015), ADAMS Accession Nos.
ML15258A389, ML15258A369, ML15258A370, ML15258A390, ML15258A391, ML15258A392, ML15258A393.
NRC-006D   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.4-1 through Figure 2.4-11 (August 27, 2015), ADAMS Accession No. ML15258A395.
NRC-006E   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-1 through Figure 2.5-6 (August 27, 2015), ADAMS Accession No. ML15258A396.
 
Panel Exhibit Number/Sponsoring                       Document Description/Title Number Witness(es)
NRC-006F           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-7 through Figure 2.5-23 (August 27, 2015), ADAMS Accession No. ML15258A398.
NRC-006G           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 3 through Chapter 18 (August 27, 2015), ADAMS Accession Nos. ML15258A371, ML15258A372, ML15258A373, ML15258A374, ML15258A375, ML15258A376, ML15258A377, ML15258A378. ML15258A379, ML15258A380, ML15258A381, ML15258A382, ML15258A383, ML15258A384, ML15258A385, ML15258A386, ML15258A387, ML15258A388, ML15258A399, ML15258A400, ML15258A402, ML15258A403, ML15258A404, ML15258A405, ML15258A406, ML15258A407, ML15258A408, ML15258A409, ML15258A410, ML15258A411.
NRC-006H           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, beginning through end of text and Chapter 19, Figure 19.2.1-1 through Figure 19.2.3-1 (August 27, 2015), ADAMS Accession Nos.
ML15258A419, ML15258A412, ML15258A413, ML15258A414, ML15258A415, ML15258A416, ML15258A417, ML15258A418, ML15258A420.
NRC-006J 1        Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.3.1-1 through Figure 19.3.1-6 (August 27, 2015), ADAMS Accession No. ML15258A421.
NRC-006K           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19 Figure 19.3.1-7 through Figure 19.3.1-9 (August 27, 2015), ADAMS Accession No. ML15258A422.
NRC-006L           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.3.2-1 through Figure 19.3.2-36 (August 27, 2015), ADAMS Accession No. ML15258A423.
NRC-006M           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.3.3-1 through Figure 19.3.3-7 (August 27, 2015), ADAMS Accession No. ML15258A424.
1 The letter I was skipped to avoid potential confusion with the number 1.
 
Panel Exhibit Number/Sponsoring           Document Description/Title Number Witness(es)
NRC-006N   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, Chapter 19 Figure 19.3.4-1 to Chapter 19 Figure 19.3.4-8 (August 27, 2015), ADAMS Accession No. ML15258A426.
NRC-006O   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19 Figure 19.3.5-1 through Figure 19.3.8-2 (August 27, 2015), ADAMS Accession No. ML15258A427.
NRC-006P   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19 Figure 19.4.1-1 through Figure 19.4.13-1 (August 27, 2015), ADAMS Accession No. ML15258A428.
NRC-006Q   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.5.2-1 through Figure 19.5.2-5 (August 27, 2015), ADAMS Accession No. ML15258A429.
NRC-006R   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.5.2-6 through Figure 19.5.2-9 (August 27, 2015), ADAMS Accession No. ML15258A430.
NRC-007A   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - General and Financial Information, Non-public (March 26, 2013), ADAMS Accession No. ML13088A193.
NRC-007B   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR],
beginning through Chapter 3 (August 27, 2015),
ADAMS Accession Nos. ML15258A332, ML15258A322, ML15258A323, ML15258A324, ML15258A333, ML15258A334.
NRC-007C   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -
[PSAR],and Environmental Report, [PSAR]
Chapter 4 through Chapter 19 (August 27, 2015),
ADAMS Accession Nos. ML15258A325, ML15258A326, ML15258A327, ML15258A328, ML15258A329, ML15258A330, ML15258A331, ML15258A335, ML15258A336, ML15258A337, ML15258A338, ML15258A339, ML15258A340, ML15258A341, ML15258A342, ML15258A343.
 
Panel Exhibit Number/Sponsoring             Document Description/Title Number Witness(es)
NRC-007D   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -
Preliminary Emergency Plan (September 25, 2013), ADAMS Accession No. ML13269A379.
NRC-008   Mirela Gavrilas   Safety Evaluation Report related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medial Radioisotope Production Facility, (revised December 8, 2015)
NRC-009   Jane Marshall     NUREG-2183, Final Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (October 16, 2015), ADAMS Accession No. ML15288A046.
NRC-010   Mirela Gavrilas & Staff Presentation Slides - Overview (December 8, Jane Marshall    2015).
NRC-011   Mirela Gavrilas   Staff Presentation Slides - Safety Panel 1 (December 8, 2015).
NRC-012-R Mirela Gavrilas   Staff Presentation Slides - Safety Panel 2 (December 8, 2015, Corrected Exhibit Filed December 11, 2015).
NRC-013   Jane Marshall     Staff Presentation Slides - Environmental Panel (December 8, 2015).
 
NRC Staff Witness List for SHINE Construction Permit Hearing Safety Witness                                   Staff Office Alexander Adams                       Office of Nuclear Reactor Regulation John Adams                           Office of Nuclear Reactor Regulation Mary Adams                           Office of Nuclear Material Safety and Safeguards Stephen Alexander                     Information Systems Laboratories David Back                           Information Systems Laboratories Marissa Bailey                       Office of Nuclear Material Safety and Safeguards Daniel Barss                         Office of Nuclear Security and Incident Response Thomas Boyle                         Office of Regulatory Research Gregory Chapman                       Office of Nuclear Material Safety and Safeguards Jorge Cintron-Rivera                 Office of Nuclear Material Safety and Safeguards William Dean                         Office of Nuclear Reactor Regulation James Downs                           Office of Nuclear Material Safety and Safeguards Thomas Essig                         Information Systems Laboratories Mirela Gavrilas                       Office of Nuclear Reactor Regulation Mary Gitnick                         Information Systems Laboratories James Hammelman                       Office of Nuclear Material Safety and Safeguards Shawn Harwell                         Office of Nuclear Reactor Regulation Christopher Heysel                   Information Systems Laboratories Gregory Hofer                         Information Systems Laboratories Anthony Huffert                       Office of Regulatory Research Steven Lynch                         Office of Nuclear Reactor Regulation Stephen Marschke                     Information Systems Laboratories James Mcllvaine                       Information Systems Laboratories Diane Mlynarczyk                     Information Systems Laboratories Kevin Morrissey                       Office of Nuclear Material Safety and Safeguards Thomas Pham                           Office of Nuclear Material Safety and Safeguards Paul Prescott                         Office of New Reactors Michael Salay                         Office of Regulatory Research Alexander Sapountzis                 Office of Nuclear Security and Incident Response Raymond Skarda                       Office of Regulatory Research Soly Soto-Lugo                       Office of Nuclear Material Safety and Safeguards Joseph Staudenmeier                   Office of Regulatory Research Christopher Tripp                     Office of Nuclear Material Safety and Safeguards Glenn Tuttle                         Office of Nuclear Material Safety and Safeguards Carl Weber                           Office of New Reactors Abraham Weitzberg                     Information Systems Laboratories Environmental Witness                                 Staff Office Kevin Folk                           Office of Nuclear Reactor Regulation Robert Hoffman                       Office of Nuclear Reactor Regulation Jane Marshall                         Office of Nuclear Reactor Regulation Nancy Martinez                       Office of Nuclear Reactor Regulation Michelle Moser                       Office of Nuclear Reactor Regulation Jeffrey Rikhoff                       Office of Nuclear Reactor Regulation
 
William Rautzen Office of Nuclear Reactor Regulation David Wrona     Office of Nuclear Reactor Regulation
 
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of                                 )
                                                  )
SHINE MEDICAL TECHNOLOGIES, INC.                 )   Docket No. M-50-608-CP
                                                  )
(Medical Radioisotope Production Facility)       )
                                                  )
CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing NRC STAFF REVISED EXHIBIT LIST AND WITNESS LIST, dated December 11, 2015, and Exhibit NRC-012-R have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 11th day of December, 2015.
                                            /Signed (electronically) by/
Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015
 
December 11, 2015 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of                                   )
                                                    )
SHINE MEDICAL TECHNOLOGIES, INC.                   ) Docket No. M-50-608-CP
                                                    )
(Medical Radioisotope Production Facility)         )
                                                    )
REVISED NRC STAFF EXHIBIT LIST AND WITNESS LIST The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its revised exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). The exhibit list is being revised to reflect the filing of a revision to Exhibit NRC-012, Staff Presentation Slides - Safety Panel 2, designated as NRC-012-R.
The revision is necessary to correct the fifth bullet on Slide 6, Safety Concept, of Exhibit NRC-012, which states, Emergency planning zone is the site boundary. The modified bullet states, Emergency planning zone could be the operational boundary. This modification is to accurately reflect, as stated in the Staffs Safety Evaluation Report, that (1) an Emergency Planning Zone (EPZ) need not be established before issuance of a construction permit and (2) consistent with the guidance in ANSI/ANS-15.16, an acceptable EPZ could be the operational boundary of the SHINE facility. Staff counsel informed Applicants counsel of the revision described above and Applicants counsel has no objection.
The Staff also hereby files a revised witness list for the mandatory hearing on SHINEs construction permit application. The witness list is being revised to correct a misspelling of a name (Down should be Downs) and to add one additional witness (John Adams). Staff counsel informed Applicants counsel of the revisions to the witness list and Applicants counsel has no objection.
 
Respectfully submitted,
                                /Signed (electronically) by/
Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Executed in accord with 10 CFR 2.304(d)
Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015
 
Staff Exhibits for SHINE Mandatory Hearing Panel Exhibit Number/Sponsoring                   Document Description/Title Number Witness(es)
NRC-001   Mirela Gavrilas &       SECY-15-0130, Staff Statement in Support of the Jane Marshall          Uncontested Hearing for Issuance of Construction Permit for the SHINE Medical Technologies, Inc.
Medical Radioisotope Production Facility (October 22, 2015), ADAMS Accession No. ML15272A004.
NRC-002   Mirela Gavrilas         Draft Construction Permit for SHINE Medical Technologies, Inc. (December 8, 2015).
NRC-003   Jane Marshall           Draft Record of Decision for SHINE Medical Technologies, Inc. Construction Permit Application (November 17, 2015), ADAMS Accession No. ML15272A019.
NRC-004-R Mirela Gavrilas &       NRC Staff Responses to Commission Pre-Hearing Jane Marshall          Questions, (originally filed on November 24, 2015),
(revised December 8, 2015)
NRC-005   Mirela Gavrilas &       NON-PUBLIC - NRC Staff Responses to Jane Marshall          Commission Pre-Hearing Questions, Non-public (filed on November 24, 2015), ADAMS Accession No. ML15328A545.
NRC-006A   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - Cover Letter and General and Financial Information (March 26, 2013), ADAMS Accession No. ML13088A192.
NRC-006B   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - Updated General Information (September 16, 2015), ADAMS Accession No. ML15259A272.
NRC-006C   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Safety Analysis Report (PSAR), beginning through Chapter 2, Figure 2.3-36 (August 27, 2015), ADAMS Accession Nos.
ML15258A389, ML15258A369, ML15258A370, ML15258A390, ML15258A391, ML15258A392, ML15258A393.
NRC-006D   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.4-1 through Figure 2.4-11 (August 27, 2015), ADAMS Accession No. ML15258A395.
NRC-006E   Mirela Gavrilas         SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-1 through Figure 2.5-6 (August 27, 2015), ADAMS Accession No. ML15258A396.
 
Panel Exhibit Number/Sponsoring                       Document Description/Title Number Witness(es)
NRC-006F           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-7 through Figure 2.5-23 (August 27, 2015), ADAMS Accession No. ML15258A398.
NRC-006G           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 3 through Chapter 18 (August 27, 2015), ADAMS Accession Nos. ML15258A371, ML15258A372, ML15258A373, ML15258A374, ML15258A375, ML15258A376, ML15258A377, ML15258A378. ML15258A379, ML15258A380, ML15258A381, ML15258A382, ML15258A383, ML15258A384, ML15258A385, ML15258A386, ML15258A387, ML15258A388, ML15258A399, ML15258A400, ML15258A402, ML15258A403, ML15258A404, ML15258A405, ML15258A406, ML15258A407, ML15258A408, ML15258A409, ML15258A410, ML15258A411.
NRC-006H           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, beginning through end of text and Chapter 19, Figure 19.2.1-1 through Figure 19.2.3-1 (August 27, 2015), ADAMS Accession Nos.
ML15258A419, ML15258A412, ML15258A413, ML15258A414, ML15258A415, ML15258A416, ML15258A417, ML15258A418, ML15258A420.
NRC-006J 1        Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.3.1-1 through Figure 19.3.1-6 (August 27, 2015), ADAMS Accession No. ML15258A421.
NRC-006K           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19 Figure 19.3.1-7 through Figure 19.3.1-9 (August 27, 2015), ADAMS Accession No. ML15258A422.
NRC-006L           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.3.2-1 through Figure 19.3.2-36 (August 27, 2015), ADAMS Accession No. ML15258A423.
NRC-006M           Mirela Gavrilas           SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.3.3-1 through Figure 19.3.3-7 (August 27, 2015), ADAMS Accession No. ML15258A424.
1 The letter I was skipped to avoid potential confusion with the number 1.
 
Panel Exhibit Number/Sponsoring           Document Description/Title Number Witness(es)
NRC-006N   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, Chapter 19 Figure 19.3.4-1 to Chapter 19 Figure 19.3.4-8 (August 27, 2015), ADAMS Accession No. ML15258A426.
NRC-006O   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19 Figure 19.3.5-1 through Figure 19.3.8-2 (August 27, 2015), ADAMS Accession No. ML15258A427.
NRC-006P   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19 Figure 19.4.1-1 through Figure 19.4.13-1 (August 27, 2015), ADAMS Accession No. ML15258A428.
NRC-006Q   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.5.2-1 through Figure 19.5.2-5 (August 27, 2015), ADAMS Accession No. ML15258A429.
NRC-006R   Mirela Gavrilas   SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]
Chapter 19, Figure 19.5.2-6 through Figure 19.5.2-9 (August 27, 2015), ADAMS Accession No. ML15258A430.
NRC-007A   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - General and Financial Information, Non-public (March 26, 2013), ADAMS Accession No. ML13088A193.
NRC-007B   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR],
beginning through Chapter 3 (August 27, 2015),
ADAMS Accession Nos. ML15258A332, ML15258A322, ML15258A323, ML15258A324, ML15258A333, ML15258A334.
NRC-007C   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -
[PSAR],and Environmental Report, [PSAR]
Chapter 4 through Chapter 19 (August 27, 2015),
ADAMS Accession Nos. ML15258A325, ML15258A326, ML15258A327, ML15258A328, ML15258A329, ML15258A330, ML15258A331, ML15258A335, ML15258A336, ML15258A337, ML15258A338, ML15258A339, ML15258A340, ML15258A341, ML15258A342, ML15258A343.
 
Panel Exhibit Number/Sponsoring             Document Description/Title Number Witness(es)
NRC-007D   Mirela Gavrilas   NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -
Preliminary Emergency Plan (September 25, 2013), ADAMS Accession No. ML13269A379.
NRC-008   Mirela Gavrilas   Safety Evaluation Report related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medial Radioisotope Production Facility, (revised December 8, 2015)
NRC-009   Jane Marshall     NUREG-2183, Final Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (October 16, 2015), ADAMS Accession No. ML15288A046.
NRC-010   Mirela Gavrilas & Staff Presentation Slides - Overview (December 8, Jane Marshall    2015).
NRC-011   Mirela Gavrilas   Staff Presentation Slides - Safety Panel 1 (December 8, 2015).
NRC-012-R Mirela Gavrilas   Staff Presentation Slides - Safety Panel 2 (December 8, 2015, Corrected Exhibit Filed December 11, 2015).
NRC-013   Jane Marshall     Staff Presentation Slides - Environmental Panel (December 8, 2015).
 
NRC Staff Witness List for SHINE Construction Permit Hearing Safety Witness                                   Staff Office Alexander Adams                       Office of Nuclear Reactor Regulation John Adams                           Office of Nuclear Reactor Regulation Mary Adams                           Office of Nuclear Material Safety and Safeguards Stephen Alexander                     Information Systems Laboratories David Back                           Information Systems Laboratories Marissa Bailey                       Office of Nuclear Material Safety and Safeguards Daniel Barss                         Office of Nuclear Security and Incident Response Thomas Boyle                         Office of Regulatory Research Gregory Chapman                       Office of Nuclear Material Safety and Safeguards Jorge Cintron-Rivera                 Office of Nuclear Material Safety and Safeguards William Dean                         Office of Nuclear Reactor Regulation James Downs                           Office of Nuclear Material Safety and Safeguards Thomas Essig                         Information Systems Laboratories Mirela Gavrilas                       Office of Nuclear Reactor Regulation Mary Gitnick                         Information Systems Laboratories James Hammelman                       Office of Nuclear Material Safety and Safeguards Shawn Harwell                         Office of Nuclear Reactor Regulation Christopher Heysel                   Information Systems Laboratories Gregory Hofer                         Information Systems Laboratories Anthony Huffert                       Office of Regulatory Research Steven Lynch                         Office of Nuclear Reactor Regulation Stephen Marschke                     Information Systems Laboratories James Mcllvaine                       Information Systems Laboratories Diane Mlynarczyk                     Information Systems Laboratories Kevin Morrissey                       Office of Nuclear Material Safety and Safeguards Thomas Pham                           Office of Nuclear Material Safety and Safeguards Paul Prescott                         Office of New Reactors Michael Salay                         Office of Regulatory Research Alexander Sapountzis                 Office of Nuclear Security and Incident Response Raymond Skarda                       Office of Regulatory Research Soly Soto-Lugo                       Office of Nuclear Material Safety and Safeguards Joseph Staudenmeier                   Office of Regulatory Research Christopher Tripp                     Office of Nuclear Material Safety and Safeguards Glenn Tuttle                         Office of Nuclear Material Safety and Safeguards Carl Weber                           Office of New Reactors Abraham Weitzberg                     Information Systems Laboratories Environmental Witness                                 Staff Office Kevin Folk                           Office of Nuclear Reactor Regulation Robert Hoffman                       Office of Nuclear Reactor Regulation Jane Marshall                         Office of Nuclear Reactor Regulation Nancy Martinez                       Office of Nuclear Reactor Regulation Michelle Moser                       Office of Nuclear Reactor Regulation Jeffrey Rikhoff                       Office of Nuclear Reactor Regulation
 
William Rautzen Office of Nuclear Reactor Regulation David Wrona     Office of Nuclear Reactor Regulation
 
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of                                 )
                                                  )
SHINE MEDICAL TECHNOLOGIES, INC.                 )   Docket No. M-50-608-CP
                                                  )
(Medical Radioisotope Production Facility)       )
                                                  )
CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing NRC STAFF REVISED EXHIBIT LIST AND WITNESS LIST, dated December 11, 2015, and Exhibit NRC-012-R have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 11th day of December, 2015.
                                            /Signed (electronically) by/
Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015}}

Latest revision as of 06:55, 5 February 2020

Revised NRC Exhibit List and Witness List
ML15345A070
Person / Time
Site: SHINE Medical Technologies
Issue date: 12/11/2015
From: Catherine Kanatas
NRC/OGC
To:
NRC/OCM
SECY RAS
References
50-608-CP, Mandatory Hearing 2, RAS 28652
Download: ML15345A070 (9)
v • d • e


Text

December 11, 2015 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP

)

(Medical Radioisotope Production Facility) )

)

REVISED NRC STAFF EXHIBIT LIST AND WITNESS LIST The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its revised exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). The exhibit list is being revised to reflect the filing of a revision to Exhibit NRC-012, Staff Presentation Slides - Safety Panel 2, designated as NRC-012-R.

The revision is necessary to correct the fifth bullet on Slide 6, Safety Concept, of Exhibit NRC-012, which states, Emergency planning zone is the site boundary. The modified bullet states, Emergency planning zone could be the operational boundary. This modification is to accurately reflect, as stated in the Staffs Safety Evaluation Report, that (1) an Emergency Planning Zone (EPZ) need not be established before issuance of a construction permit and (2) consistent with the guidance in ANSI/ANS-15.16, an acceptable EPZ could be the operational boundary of the SHINE facility. Staff counsel informed Applicants counsel of the revision described above and Applicants counsel has no objection.

The Staff also hereby files a revised witness list for the mandatory hearing on SHINEs construction permit application. The witness list is being revised to correct a misspelling of a name (Down should be Downs) and to add one additional witness (John Adams). Staff counsel informed Applicants counsel of the revisions to the witness list and Applicants counsel has no objection.

Respectfully submitted,

/Signed (electronically) by/

Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Executed in accord with 10 CFR 2.304(d)

Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015

Staff Exhibits for SHINE Mandatory Hearing Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-001 Mirela Gavrilas & SECY-15-0130, Staff Statement in Support of the Jane Marshall Uncontested Hearing for Issuance of Construction Permit for the SHINE Medical Technologies, Inc.

Medical Radioisotope Production Facility (October 22, 2015), ADAMS Accession No. ML15272A004.

NRC-002 Mirela Gavrilas Draft Construction Permit for SHINE Medical Technologies, Inc. (December 8, 2015).

NRC-003 Jane Marshall Draft Record of Decision for SHINE Medical Technologies, Inc. Construction Permit Application (November 17, 2015), ADAMS Accession No. ML15272A019.

NRC-004-R Mirela Gavrilas & NRC Staff Responses to Commission Pre-Hearing Jane Marshall Questions, (originally filed on November 24, 2015),

(revised December 8, 2015)

NRC-005 Mirela Gavrilas & NON-PUBLIC - NRC Staff Responses to Jane Marshall Commission Pre-Hearing Questions, Non-public (filed on November 24, 2015), ADAMS Accession No. ML15328A545.

NRC-006A Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Cover Letter and General and Financial Information (March 26, 2013), ADAMS Accession No. ML13088A192.

NRC-006B Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Updated General Information (September 16, 2015), ADAMS Accession No. ML15259A272.

NRC-006C Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Safety Analysis Report (PSAR), beginning through Chapter 2, Figure 2.3-36 (August 27, 2015), ADAMS Accession Nos.

ML15258A389, ML15258A369, ML15258A370, ML15258A390, ML15258A391, ML15258A392, ML15258A393.

NRC-006D Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.4-1 through Figure 2.4-11 (August 27, 2015), ADAMS Accession No. ML15258A395.

NRC-006E Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-1 through Figure 2.5-6 (August 27, 2015), ADAMS Accession No. ML15258A396.

Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-006F Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-7 through Figure 2.5-23 (August 27, 2015), ADAMS Accession No. ML15258A398.

NRC-006G Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 3 through Chapter 18 (August 27, 2015), ADAMS Accession Nos. ML15258A371, ML15258A372, ML15258A373, ML15258A374, ML15258A375, ML15258A376, ML15258A377, ML15258A378. ML15258A379, ML15258A380, ML15258A381, ML15258A382, ML15258A383, ML15258A384, ML15258A385, ML15258A386, ML15258A387, ML15258A388, ML15258A399, ML15258A400, ML15258A402, ML15258A403, ML15258A404, ML15258A405, ML15258A406, ML15258A407, ML15258A408, ML15258A409, ML15258A410, ML15258A411.

NRC-006H Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, beginning through end of text and Chapter 19, Figure 19.2.1-1 through Figure 19.2.3-1 (August 27, 2015), ADAMS Accession Nos.

ML15258A419, ML15258A412, ML15258A413, ML15258A414, ML15258A415, ML15258A416, ML15258A417, ML15258A418, ML15258A420.

NRC-006J 1 Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.3.1-1 through Figure 19.3.1-6 (August 27, 2015), ADAMS Accession No. ML15258A421.

NRC-006K Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19 Figure 19.3.1-7 through Figure 19.3.1-9 (August 27, 2015), ADAMS Accession No. ML15258A422.

NRC-006L Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.3.2-1 through Figure 19.3.2-36 (August 27, 2015), ADAMS Accession No. ML15258A423.

NRC-006M Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.3.3-1 through Figure 19.3.3-7 (August 27, 2015), ADAMS Accession No. ML15258A424.

1 The letter I was skipped to avoid potential confusion with the number 1.

Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-006N Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, Chapter 19 Figure 19.3.4-1 to Chapter 19 Figure 19.3.4-8 (August 27, 2015), ADAMS Accession No. ML15258A426.

NRC-006O Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19 Figure 19.3.5-1 through Figure 19.3.8-2 (August 27, 2015), ADAMS Accession No. ML15258A427.

NRC-006P Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19 Figure 19.4.1-1 through Figure 19.4.13-1 (August 27, 2015), ADAMS Accession No. ML15258A428.

NRC-006Q Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.5.2-1 through Figure 19.5.2-5 (August 27, 2015), ADAMS Accession No. ML15258A429.

NRC-006R Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.5.2-6 through Figure 19.5.2-9 (August 27, 2015), ADAMS Accession No. ML15258A430.

NRC-007A Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - General and Financial Information, Non-public (March 26, 2013), ADAMS Accession No. ML13088A193.

NRC-007B Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR],

beginning through Chapter 3 (August 27, 2015),

ADAMS Accession Nos. ML15258A332, ML15258A322, ML15258A323, ML15258A324, ML15258A333, ML15258A334.

NRC-007C Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -

[PSAR],and Environmental Report, [PSAR]

Chapter 4 through Chapter 19 (August 27, 2015),

ADAMS Accession Nos. ML15258A325, ML15258A326, ML15258A327, ML15258A328, ML15258A329, ML15258A330, ML15258A331, ML15258A335, ML15258A336, ML15258A337, ML15258A338, ML15258A339, ML15258A340, ML15258A341, ML15258A342, ML15258A343.

Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-007D Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -

Preliminary Emergency Plan (September 25, 2013), ADAMS Accession No. ML13269A379.

NRC-008 Mirela Gavrilas Safety Evaluation Report related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medial Radioisotope Production Facility, (revised December 8, 2015)

NRC-009 Jane Marshall NUREG-2183, Final Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (October 16, 2015), ADAMS Accession No. ML15288A046.

NRC-010 Mirela Gavrilas & Staff Presentation Slides - Overview (December 8, Jane Marshall 2015).

NRC-011 Mirela Gavrilas Staff Presentation Slides - Safety Panel 1 (December 8, 2015).

NRC-012-R Mirela Gavrilas Staff Presentation Slides - Safety Panel 2 (December 8, 2015, Corrected Exhibit Filed December 11, 2015).

NRC-013 Jane Marshall Staff Presentation Slides - Environmental Panel (December 8, 2015).

NRC Staff Witness List for SHINE Construction Permit Hearing Safety Witness Staff Office Alexander Adams Office of Nuclear Reactor Regulation John Adams Office of Nuclear Reactor Regulation Mary Adams Office of Nuclear Material Safety and Safeguards Stephen Alexander Information Systems Laboratories David Back Information Systems Laboratories Marissa Bailey Office of Nuclear Material Safety and Safeguards Daniel Barss Office of Nuclear Security and Incident Response Thomas Boyle Office of Regulatory Research Gregory Chapman Office of Nuclear Material Safety and Safeguards Jorge Cintron-Rivera Office of Nuclear Material Safety and Safeguards William Dean Office of Nuclear Reactor Regulation James Downs Office of Nuclear Material Safety and Safeguards Thomas Essig Information Systems Laboratories Mirela Gavrilas Office of Nuclear Reactor Regulation Mary Gitnick Information Systems Laboratories James Hammelman Office of Nuclear Material Safety and Safeguards Shawn Harwell Office of Nuclear Reactor Regulation Christopher Heysel Information Systems Laboratories Gregory Hofer Information Systems Laboratories Anthony Huffert Office of Regulatory Research Steven Lynch Office of Nuclear Reactor Regulation Stephen Marschke Information Systems Laboratories James Mcllvaine Information Systems Laboratories Diane Mlynarczyk Information Systems Laboratories Kevin Morrissey Office of Nuclear Material Safety and Safeguards Thomas Pham Office of Nuclear Material Safety and Safeguards Paul Prescott Office of New Reactors Michael Salay Office of Regulatory Research Alexander Sapountzis Office of Nuclear Security and Incident Response Raymond Skarda Office of Regulatory Research Soly Soto-Lugo Office of Nuclear Material Safety and Safeguards Joseph Staudenmeier Office of Regulatory Research Christopher Tripp Office of Nuclear Material Safety and Safeguards Glenn Tuttle Office of Nuclear Material Safety and Safeguards Carl Weber Office of New Reactors Abraham Weitzberg Information Systems Laboratories Environmental Witness Staff Office Kevin Folk Office of Nuclear Reactor Regulation Robert Hoffman Office of Nuclear Reactor Regulation Jane Marshall Office of Nuclear Reactor Regulation Nancy Martinez Office of Nuclear Reactor Regulation Michelle Moser Office of Nuclear Reactor Regulation Jeffrey Rikhoff Office of Nuclear Reactor Regulation

William Rautzen Office of Nuclear Reactor Regulation David Wrona Office of Nuclear Reactor Regulation

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP

)

(Medical Radioisotope Production Facility) )

)

CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing NRC STAFF REVISED EXHIBIT LIST AND WITNESS LIST, dated December 11, 2015, and Exhibit NRC-012-R have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 11th day of December, 2015.

/Signed (electronically) by/

Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015

December 11, 2015 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP

)

(Medical Radioisotope Production Facility) )

)

REVISED NRC STAFF EXHIBIT LIST AND WITNESS LIST The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its revised exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). The exhibit list is being revised to reflect the filing of a revision to Exhibit NRC-012, Staff Presentation Slides - Safety Panel 2, designated as NRC-012-R.

The revision is necessary to correct the fifth bullet on Slide 6, Safety Concept, of Exhibit NRC-012, which states, Emergency planning zone is the site boundary. The modified bullet states, Emergency planning zone could be the operational boundary. This modification is to accurately reflect, as stated in the Staffs Safety Evaluation Report, that (1) an Emergency Planning Zone (EPZ) need not be established before issuance of a construction permit and (2) consistent with the guidance in ANSI/ANS-15.16, an acceptable EPZ could be the operational boundary of the SHINE facility. Staff counsel informed Applicants counsel of the revision described above and Applicants counsel has no objection.

The Staff also hereby files a revised witness list for the mandatory hearing on SHINEs construction permit application. The witness list is being revised to correct a misspelling of a name (Down should be Downs) and to add one additional witness (John Adams). Staff counsel informed Applicants counsel of the revisions to the witness list and Applicants counsel has no objection.

Respectfully submitted,

/Signed (electronically) by/

Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Executed in accord with 10 CFR 2.304(d)

Mitzi A. Young Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-3830 E-mail: Mitzi.Young@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015

Staff Exhibits for SHINE Mandatory Hearing Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-001 Mirela Gavrilas & SECY-15-0130, Staff Statement in Support of the Jane Marshall Uncontested Hearing for Issuance of Construction Permit for the SHINE Medical Technologies, Inc.

Medical Radioisotope Production Facility (October 22, 2015), ADAMS Accession No. ML15272A004.

NRC-002 Mirela Gavrilas Draft Construction Permit for SHINE Medical Technologies, Inc. (December 8, 2015).

NRC-003 Jane Marshall Draft Record of Decision for SHINE Medical Technologies, Inc. Construction Permit Application (November 17, 2015), ADAMS Accession No. ML15272A019.

NRC-004-R Mirela Gavrilas & NRC Staff Responses to Commission Pre-Hearing Jane Marshall Questions, (originally filed on November 24, 2015),

(revised December 8, 2015)

NRC-005 Mirela Gavrilas & NON-PUBLIC - NRC Staff Responses to Jane Marshall Commission Pre-Hearing Questions, Non-public (filed on November 24, 2015), ADAMS Accession No. ML15328A545.

NRC-006A Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Cover Letter and General and Financial Information (March 26, 2013), ADAMS Accession No. ML13088A192.

NRC-006B Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Updated General Information (September 16, 2015), ADAMS Accession No. ML15259A272.

NRC-006C Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Preliminary Safety Analysis Report (PSAR), beginning through Chapter 2, Figure 2.3-36 (August 27, 2015), ADAMS Accession Nos.

ML15258A389, ML15258A369, ML15258A370, ML15258A390, ML15258A391, ML15258A392, ML15258A393.

NRC-006D Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.4-1 through Figure 2.4-11 (August 27, 2015), ADAMS Accession No. ML15258A395.

NRC-006E Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-1 through Figure 2.5-6 (August 27, 2015), ADAMS Accession No. ML15258A396.

Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-006F Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 2, Figure 2.5-7 through Figure 2.5-23 (August 27, 2015), ADAMS Accession No. ML15258A398.

NRC-006G Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR], Chapter 3 through Chapter 18 (August 27, 2015), ADAMS Accession Nos. ML15258A371, ML15258A372, ML15258A373, ML15258A374, ML15258A375, ML15258A376, ML15258A377, ML15258A378. ML15258A379, ML15258A380, ML15258A381, ML15258A382, ML15258A383, ML15258A384, ML15258A385, ML15258A386, ML15258A387, ML15258A388, ML15258A399, ML15258A400, ML15258A402, ML15258A403, ML15258A404, ML15258A405, ML15258A406, ML15258A407, ML15258A408, ML15258A409, ML15258A410, ML15258A411.

NRC-006H Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, beginning through end of text and Chapter 19, Figure 19.2.1-1 through Figure 19.2.3-1 (August 27, 2015), ADAMS Accession Nos.

ML15258A419, ML15258A412, ML15258A413, ML15258A414, ML15258A415, ML15258A416, ML15258A417, ML15258A418, ML15258A420.

NRC-006J 1 Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.3.1-1 through Figure 19.3.1-6 (August 27, 2015), ADAMS Accession No. ML15258A421.

NRC-006K Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19 Figure 19.3.1-7 through Figure 19.3.1-9 (August 27, 2015), ADAMS Accession No. ML15258A422.

NRC-006L Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.3.2-1 through Figure 19.3.2-36 (August 27, 2015), ADAMS Accession No. ML15258A423.

NRC-006M Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.3.3-1 through Figure 19.3.3-7 (August 27, 2015), ADAMS Accession No. ML15258A424.

1 The letter I was skipped to avoid potential confusion with the number 1.

Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-006N Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, Chapter 19 Figure 19.3.4-1 to Chapter 19 Figure 19.3.4-8 (August 27, 2015), ADAMS Accession No. ML15258A426.

NRC-006O Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19 Figure 19.3.5-1 through Figure 19.3.8-2 (August 27, 2015), ADAMS Accession No. ML15258A427.

NRC-006P Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19 Figure 19.4.1-1 through Figure 19.4.13-1 (August 27, 2015), ADAMS Accession No. ML15258A428.

NRC-006Q Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.5.2-1 through Figure 19.5.2-5 (August 27, 2015), ADAMS Accession No. ML15258A429.

NRC-006R Mirela Gavrilas SHINE Medical Technologies, Inc., Construction Permit Application - Environmental Report, [PSAR]

Chapter 19, Figure 19.5.2-6 through Figure 19.5.2-9 (August 27, 2015), ADAMS Accession No. ML15258A430.

NRC-007A Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - General and Financial Information, Non-public (March 26, 2013), ADAMS Accession No. ML13088A193.

NRC-007B Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application - [PSAR],

beginning through Chapter 3 (August 27, 2015),

ADAMS Accession Nos. ML15258A332, ML15258A322, ML15258A323, ML15258A324, ML15258A333, ML15258A334.

NRC-007C Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -

[PSAR],and Environmental Report, [PSAR]

Chapter 4 through Chapter 19 (August 27, 2015),

ADAMS Accession Nos. ML15258A325, ML15258A326, ML15258A327, ML15258A328, ML15258A329, ML15258A330, ML15258A331, ML15258A335, ML15258A336, ML15258A337, ML15258A338, ML15258A339, ML15258A340, ML15258A341, ML15258A342, ML15258A343.

Panel Exhibit Number/Sponsoring Document Description/Title Number Witness(es)

NRC-007D Mirela Gavrilas NON-PUBLIC - SHINE Medical Technologies, Inc., Construction Permit Application -

Preliminary Emergency Plan (September 25, 2013), ADAMS Accession No. ML13269A379.

NRC-008 Mirela Gavrilas Safety Evaluation Report related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medial Radioisotope Production Facility, (revised December 8, 2015)

NRC-009 Jane Marshall NUREG-2183, Final Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility (October 16, 2015), ADAMS Accession No. ML15288A046.

NRC-010 Mirela Gavrilas & Staff Presentation Slides - Overview (December 8, Jane Marshall 2015).

NRC-011 Mirela Gavrilas Staff Presentation Slides - Safety Panel 1 (December 8, 2015).

NRC-012-R Mirela Gavrilas Staff Presentation Slides - Safety Panel 2 (December 8, 2015, Corrected Exhibit Filed December 11, 2015).

NRC-013 Jane Marshall Staff Presentation Slides - Environmental Panel (December 8, 2015).

NRC Staff Witness List for SHINE Construction Permit Hearing Safety Witness Staff Office Alexander Adams Office of Nuclear Reactor Regulation John Adams Office of Nuclear Reactor Regulation Mary Adams Office of Nuclear Material Safety and Safeguards Stephen Alexander Information Systems Laboratories David Back Information Systems Laboratories Marissa Bailey Office of Nuclear Material Safety and Safeguards Daniel Barss Office of Nuclear Security and Incident Response Thomas Boyle Office of Regulatory Research Gregory Chapman Office of Nuclear Material Safety and Safeguards Jorge Cintron-Rivera Office of Nuclear Material Safety and Safeguards William Dean Office of Nuclear Reactor Regulation James Downs Office of Nuclear Material Safety and Safeguards Thomas Essig Information Systems Laboratories Mirela Gavrilas Office of Nuclear Reactor Regulation Mary Gitnick Information Systems Laboratories James Hammelman Office of Nuclear Material Safety and Safeguards Shawn Harwell Office of Nuclear Reactor Regulation Christopher Heysel Information Systems Laboratories Gregory Hofer Information Systems Laboratories Anthony Huffert Office of Regulatory Research Steven Lynch Office of Nuclear Reactor Regulation Stephen Marschke Information Systems Laboratories James Mcllvaine Information Systems Laboratories Diane Mlynarczyk Information Systems Laboratories Kevin Morrissey Office of Nuclear Material Safety and Safeguards Thomas Pham Office of Nuclear Material Safety and Safeguards Paul Prescott Office of New Reactors Michael Salay Office of Regulatory Research Alexander Sapountzis Office of Nuclear Security and Incident Response Raymond Skarda Office of Regulatory Research Soly Soto-Lugo Office of Nuclear Material Safety and Safeguards Joseph Staudenmeier Office of Regulatory Research Christopher Tripp Office of Nuclear Material Safety and Safeguards Glenn Tuttle Office of Nuclear Material Safety and Safeguards Carl Weber Office of New Reactors Abraham Weitzberg Information Systems Laboratories Environmental Witness Staff Office Kevin Folk Office of Nuclear Reactor Regulation Robert Hoffman Office of Nuclear Reactor Regulation Jane Marshall Office of Nuclear Reactor Regulation Nancy Martinez Office of Nuclear Reactor Regulation Michelle Moser Office of Nuclear Reactor Regulation Jeffrey Rikhoff Office of Nuclear Reactor Regulation

William Rautzen Office of Nuclear Reactor Regulation David Wrona Office of Nuclear Reactor Regulation

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE COMMISSION In the Matter of )

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP

)

(Medical Radioisotope Production Facility) )

)

CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing NRC STAFF REVISED EXHIBIT LIST AND WITNESS LIST, dated December 11, 2015, and Exhibit NRC-012-R have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 11th day of December, 2015.

/Signed (electronically) by/

Catherine E. Kanatas Counsel for NRC Staff U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop O-14-G10 Washington, DC 20555 Telephone: (301) 415-2321 E-mail: Catherine.Kanatas@nrc.gov Dated at Rockville, Maryland this 11th day of December, 2015

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