ML15363A136
| ML15363A136 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 12/29/2015 |
| From: | Kanatas C E, Young M A NRC/OGC |
| To: | NRC/OCM |
| SECY RAS | |
| References | |
| 50-608-CP, Mandatory Hearing 2, RAS 28717 | |
| Download: ML15363A136 (7) | |
Text
December 29, 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 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 (1) include the Staff's responses to the Commission's post-hearing questions as Exhibit NRC-014 and (2) reflect the filing of a revision to Exhibit NRC-002, Draft Construction Permit for SHINE Medical Technologies, Inc., that is designated as NRC-002-R. The revision to Exhibit NRC-002 is necessary to correct format and numbering errors in Appendix A of that document. Specifically, Section 2.3, "Endangered Species Act of 1973," is now correctly numbered as 2.2 on the first two pages of Appendix A and the references to Section 2.3 on the third page of Appendix A are similarly corrected. There were two pages numbered A-1. The Appendix A pages are now correctly numbered as A-1, A-2, A-3, and A-4, respectively. Page number A-1 was shifted down to match the page number location on subsequent pages. On page A-2, the title of Section 1.0 is aligned to reflect a left margin consistent with the text below it. The white background fill that made text in the last paragraph of Section 2.1 appear to be highlighted is removed. Staff counsel informed Applicant's counsel of the revisions described above. Applicant's counsel has no objection to the revised exhibit list and the admission of Exhibits NRC-014 and NRC-002-R. 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 29th 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-R Mirela Gavrilas Draft Construction Permit for SHINE Medical Technologies, Inc. (originally filed on December 8, 2015), (revised December 29, 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.
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."
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). NRC-014 Mirela Gavrilas & Jane Marshall NRC Staff Responses to Post-Hearing Questions (December 29, 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) ) ) CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing "NRC STAFF REVISED EXHIBIT LIST," dated December 29, 2015, and Exhibit NRC-002-R have been served upon the Electronic Information Exchange, the NRC's E-Filing System, in the above-captioned proceeding, this 29th 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 29th day of December, 2015 December 29, 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 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 (1) include the Staff's responses to the Commission's post-hearing questions as Exhibit NRC-014 and (2) reflect the filing of a revision to Exhibit NRC-002, Draft Construction Permit for SHINE Medical Technologies, Inc., that is designated as NRC-002-R. The revision to Exhibit NRC-002 is necessary to correct format and numbering errors in Appendix A of that document. Specifically, Section 2.3, "Endangered Species Act of 1973," is now correctly numbered as 2.2 on the first two pages of Appendix A and the references to Section 2.3 on the third page of Appendix A are similarly corrected. There were two pages numbered A-1. The Appendix A pages are now correctly numbered as A-1, A-2, A-3, and A-4, respectively. Page number A-1 was shifted down to match the page number location on subsequent pages. On page A-2, the title of Section 1.0 is aligned to reflect a left margin consistent with the text below it. The white background fill that made text in the last paragraph of Section 2.1 appear to be highlighted is removed. Staff counsel informed Applicant's counsel of the revisions described above. Applicant's counsel has no objection to the revised exhibit list and the admission of Exhibits NRC-014 and NRC-002-R. 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 29th 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-R Mirela Gavrilas Draft Construction Permit for SHINE Medical Technologies, Inc. (originally filed on December 8, 2015), (revised December 29, 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.
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."
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). NRC-014 Mirela Gavrilas & Jane Marshall NRC Staff Responses to Post-Hearing Questions (December 29, 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) ) ) CERTIFICATE OF SERVICE Pursuant to 10 C.F.R. § 2.305, I hereby certify that copies of the foregoing "NRC STAFF REVISED EXHIBIT LIST," dated December 29, 2015, and Exhibit NRC-002-R have been served upon the Electronic Information Exchange, the NRC's E-Filing System, in the above-captioned proceeding, this 29th 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 29th day of December, 2015