ML15342A348

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NRC Staff Exhibit List and Notice of Revisions
ML15342A348
Person / Time
Site: SHINE Medical Technologies
Issue date: 12/08/2015
From: Matt Young
NRC/OGC
To:
NRC/OCM
SECY RAS
References
Mandatory Hearing 2, RAS 28629, 50-608-CP
Download: ML15342A348 (10)
v • d • e


Text

December 8, 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) )

)

NRC STAFF EXHIBIT LIST AND NOTICE OF REVISIONS The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). Each exhibit has been listed and marked according to the instructions in the Commissions Scheduling Order, dated December 1, 2015.

The sections below explain changes to documents previously provided to the Commission, filed with the Commission, or made publicly available in the Agencywide Documents Access and Management System (ADAMS).

A. Changes to Staff Documents As Identified in Responses to Commission Questions As indicated in its response to the Commissions Pre-hearing Question 66, as a result of its consideration of Commission Pre-Hearing Questions 66-70, the Staff no longer proposes to include conditions related to the preliminary amendment request process and construction changes screening criteria in the draft SHINE Construction Permit. Accordingly, the Staff has revised the 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, dated October 22, 2015, the draft Construction Permit, and the Staffs Safety Evaluation Report (SER) to reflect its current position. Specifically,

  • In SECY-15-0130 (NRC-001), the following paragraph (formerly on page 19 of the SECY provided to the Commission on October 22, 2015) has been deleted:

Additionally, the draft construction permit includes a condition that requires SHINE to establish a screening and evaluation process (similar to that described in 10 CFR 50.59) for determining whether an amendment, as described in 10 CFR 50.35(b) and 50.90, is necessary before SHINE makes changes to the facility during construction or prior to issuance of an operating license. Another license condition allows SHINE to use a preliminary amendment request process during this period if a change to the facility requires an amendment. Under this process, SHINE can submit a request for an NRC staff determination on whether it objects to SHINE proceeding with construction changes before the NRCs review of the amendment request is complete. If the NRC staff cannot make the requisite findings to issue the license amendment, SHINE must return the facility back to as described in the PSAR. Thus, these conditions would provide criteria to maintain design configuration control mechanisms consistent with the safety analysis while avoiding construction delays.

  • In the draft Construction Permit, Conditions, 3.D.(2) and 3.D.(3), regarding a screening and evaluation process and preliminary amendment request process (as quoted below) are deleted:

o (2) In accordance with Appendix B to this permit, SHINE shall establish a screening and evaluation process for determining whether an amendment request is necessary before changes are implemented during construction.

o (3) SHINE may use a preliminary amendment request (PAR) process for amendments to this construction permit any time prior to the issuance of an operating license. To use the PAR process, SHINE shall submit a written request to the Office of Nuclear Reactor Regulation (NRR) in accordance with Appendix B of this permit. If SHINE elects to proceed and the amendment request is subsequently denied, SHINE shall return the facility to its previous condition, as described in the preliminary safety analysis report.

  • Consistent with the deletion of draft Construction Permit Conditions 3.D.(2) and (3), Appendix B, Screening and Evaluation Process for Changes During Construction and Preliminary Amendment Request Process, of the Construction Permit is deleted in its entirely. Condition 3.D.(4) is now renumbered as 3.D.(2) and is similarly revised to delete the reference to Appendix B. Condition 3.D.(2) now reads as follows:

(2) The Environmental Protection Plan described in Appendix A of this permit is hereby incorporated into this permit.

  • In the SER, the paragraph quoted below (which formerly appeared in SER Section 1.1.4, at page 1-8) is deleted from the Staffs SER, Exhibit NRC-008 The construction permit has a condition that SHINE shall establish a screening and evaluation process for determining whether an amendment request to the construction permit is necessary if changes are made to the design of the facility as described in the PSAR. SHINE may use a preliminary amendment request process for amendments to the construction permit. These processes are described in Appendix E, Screening and Evaluation Process for Changes During Construction and Preliminary Amendment Request Process, to this SER.
  • In the SER, the paragraph quoted below (which formerly appeared in SER Section 1.2, at page 1-12) is deleted from the Staffs SER, Exhibit NRC-008.

Additionally, the staff has proposed that the construction permit include a condition that requires SHINE to establish a screening and evaluation process (similar to that described in 10 CFR 50.59, Changes, tests and experiments) for determining whether an amendment, as described in 10 CFR 50.35(b) and 50.90, Application for amendment of license, construction permit, or early site permit, is necessary before SHINE makes changes to the facility during construction or prior to issuance of an operating license. Another license condition would allow SHINE to use a preliminary amendment request process during this period if a change to the facility requires an amendment. Under this process, SHINE can submit a request for an NRC staff determination on whether it objects to SHINE proceeding with construction changes before the NRCs review of the amendment request is complete. If the NRC staff cannot make the requisite findings to issue the license amendment, SHINE must return the facility back to as described in the PSAR. Thus, as described in Appendix E of this SER, these conditions would provide criteria to maintain design configuration control mechanisms consistent with the safety analysis while avoiding unnecessary construction delays.

As indicated in its response to Commission Pre-Hearing Question 2.b, SER, Chapter 1, page 1-5, has been revised to accurately reflect that the Staff considered all 10 CFR Part 50, Appendix A, General Design Criteria (GDCs) applied by SHINE to the proposed facility rather than just several, as indicated in the paragraph that begins, As required by 10 CFR 50.34(a)(3)(i) . . . . The bulleted list of GDCs formerly on SER pages 1-5 through 1-6 is deleted and that paragraph now states:

As required by 10 CFR 50.34(a)(3)(i), SHINE must describe the principal design criteria for its facility in the PSAR; however, SHINE is not required to follow 10 CFR Part 50, Appendix A, General Design Criteria [GDCs]

for Nuclear Power Plants, which applies only to nuclear power reactors.

Nonetheless, SHINE has applied the GDCs to the preliminary design of its facility, as appropriate. As such, the Staff based its review of SHINEs principal design criteria, in part, on SHINEs application of GDCs, as described in Tables 3.5a-1 Appendix A to 10 CFR 50 General Design Criteria Which Have Been Interpreted As They Apply to the SHINE Irradiation Facility, and 3.5b-1 Baseline and General Design Criteria for Radioisotope Production Facility, of the SHINE PSAR.

The Table of Contents in the SER has been revised to reflect the above-described revisions and deletions.

B. Corrections to Responses to the Commission Pre-Hearing Questions During its hearing preparations, the Staff determined that two of its responses to pre-hearing questions, filed on November 24, 2015, need revisions to accurately reflect the Staffs views.

In its response to Pre-Hearing Question 5.a (at page 6), the Staff described radioactive releases within the irradiation unit cell, but should have referred to the target solution vessel off-gas system (TOGS) shielded cell. Thus, the words into the atmosphere of the irradiation unit cell should be deleted from the penultimate sentence in the second paragraph. Instead, that sentence should read:

The Failure of the TOGS scenario is an accident that uses more realistic assumptions for releasing the radioactive gases inside the primary system boundary into the TOGS shielded cell.

In its response to Pre-Hearing Question 18.b (at page 13), the Staff mistakenly characterized SHINEs proposed system as over-concentrated with a negative void coefficient.

The Staff, however, meant to say that the target solution is under-concentrated. Accordingly, the term over-concentrated should be replaced with under-concentrated. The revised sentence now reads, Instead, it is better to think of SHINEs proposed systems as under-concentrated with a negative void coefficient.

The changes and corrections described above are reflected in the exhibits NRC-001, NRC-002, NRC-004-R, and NRC-008 being filed today. The Staff designated only the document reflecting the revisions to the responses to Commission Pre-Hearing Questions originally filed on November 24, 2015, as Exhibit NRC-004-R. No R designation was added to the other affected exhibits inasmuch as they were not previously filed in this proceeding.

The Staff informed SHINEs counsel of the changes and corrections described above.

SHINEs counsel has no objection to the Staff modifying the exhibits as described above.

Respectfully submitted,

/Signed (electronically) by/

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 Executed in accord with 10 CFR 2.304(d)

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 8th 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-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.

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 Mirela Gavrilas Staff Presentation Slides - Safety Panel 2 (December 8, 2015).

NRC-013 Jane Marshall Staff Presentation Slides - Environmental Panel (December 8, 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 EXHIBIT LIST AND NOTICE OF REVISIONS, dated December 8, 2015, have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 8th day of December, 2015.

/Signed (electronically) by/

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 8th day of December, 2015

December 8, 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) )

)

NRC STAFF EXHIBIT LIST AND NOTICE OF REVISIONS The U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby files its exhibit list for the mandatory hearing on the construction permit application of SHINE Medical Technologies, Inc. (SHINE). Each exhibit has been listed and marked according to the instructions in the Commissions Scheduling Order, dated December 1, 2015.

The sections below explain changes to documents previously provided to the Commission, filed with the Commission, or made publicly available in the Agencywide Documents Access and Management System (ADAMS).

A. Changes to Staff Documents As Identified in Responses to Commission Questions As indicated in its response to the Commissions Pre-hearing Question 66, as a result of its consideration of Commission Pre-Hearing Questions 66-70, the Staff no longer proposes to include conditions related to the preliminary amendment request process and construction changes screening criteria in the draft SHINE Construction Permit. Accordingly, the Staff has revised the 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, dated October 22, 2015, the draft Construction Permit, and the Staffs Safety Evaluation Report (SER) to reflect its current position. Specifically,

  • In SECY-15-0130 (NRC-001), the following paragraph (formerly on page 19 of the SECY provided to the Commission on October 22, 2015) has been deleted:

Additionally, the draft construction permit includes a condition that requires SHINE to establish a screening and evaluation process (similar to that described in 10 CFR 50.59) for determining whether an amendment, as described in 10 CFR 50.35(b) and 50.90, is necessary before SHINE makes changes to the facility during construction or prior to issuance of an operating license. Another license condition allows SHINE to use a preliminary amendment request process during this period if a change to the facility requires an amendment. Under this process, SHINE can submit a request for an NRC staff determination on whether it objects to SHINE proceeding with construction changes before the NRCs review of the amendment request is complete. If the NRC staff cannot make the requisite findings to issue the license amendment, SHINE must return the facility back to as described in the PSAR. Thus, these conditions would provide criteria to maintain design configuration control mechanisms consistent with the safety analysis while avoiding construction delays.

  • In the draft Construction Permit, Conditions, 3.D.(2) and 3.D.(3), regarding a screening and evaluation process and preliminary amendment request process (as quoted below) are deleted:

o (2) In accordance with Appendix B to this permit, SHINE shall establish a screening and evaluation process for determining whether an amendment request is necessary before changes are implemented during construction.

o (3) SHINE may use a preliminary amendment request (PAR) process for amendments to this construction permit any time prior to the issuance of an operating license. To use the PAR process, SHINE shall submit a written request to the Office of Nuclear Reactor Regulation (NRR) in accordance with Appendix B of this permit. If SHINE elects to proceed and the amendment request is subsequently denied, SHINE shall return the facility to its previous condition, as described in the preliminary safety analysis report.

  • Consistent with the deletion of draft Construction Permit Conditions 3.D.(2) and (3), Appendix B, Screening and Evaluation Process for Changes During Construction and Preliminary Amendment Request Process, of the Construction Permit is deleted in its entirely. Condition 3.D.(4) is now renumbered as 3.D.(2) and is similarly revised to delete the reference to Appendix B. Condition 3.D.(2) now reads as follows:

(2) The Environmental Protection Plan described in Appendix A of this permit is hereby incorporated into this permit.

  • In the SER, the paragraph quoted below (which formerly appeared in SER Section 1.1.4, at page 1-8) is deleted from the Staffs SER, Exhibit NRC-008 The construction permit has a condition that SHINE shall establish a screening and evaluation process for determining whether an amendment request to the construction permit is necessary if changes are made to the design of the facility as described in the PSAR. SHINE may use a preliminary amendment request process for amendments to the construction permit. These processes are described in Appendix E, Screening and Evaluation Process for Changes During Construction and Preliminary Amendment Request Process, to this SER.
  • In the SER, the paragraph quoted below (which formerly appeared in SER Section 1.2, at page 1-12) is deleted from the Staffs SER, Exhibit NRC-008.

Additionally, the staff has proposed that the construction permit include a condition that requires SHINE to establish a screening and evaluation process (similar to that described in 10 CFR 50.59, Changes, tests and experiments) for determining whether an amendment, as described in 10 CFR 50.35(b) and 50.90, Application for amendment of license, construction permit, or early site permit, is necessary before SHINE makes changes to the facility during construction or prior to issuance of an operating license. Another license condition would allow SHINE to use a preliminary amendment request process during this period if a change to the facility requires an amendment. Under this process, SHINE can submit a request for an NRC staff determination on whether it objects to SHINE proceeding with construction changes before the NRCs review of the amendment request is complete. If the NRC staff cannot make the requisite findings to issue the license amendment, SHINE must return the facility back to as described in the PSAR. Thus, as described in Appendix E of this SER, these conditions would provide criteria to maintain design configuration control mechanisms consistent with the safety analysis while avoiding unnecessary construction delays.

As indicated in its response to Commission Pre-Hearing Question 2.b, SER, Chapter 1, page 1-5, has been revised to accurately reflect that the Staff considered all 10 CFR Part 50, Appendix A, General Design Criteria (GDCs) applied by SHINE to the proposed facility rather than just several, as indicated in the paragraph that begins, As required by 10 CFR 50.34(a)(3)(i) . . . . The bulleted list of GDCs formerly on SER pages 1-5 through 1-6 is deleted and that paragraph now states:

As required by 10 CFR 50.34(a)(3)(i), SHINE must describe the principal design criteria for its facility in the PSAR; however, SHINE is not required to follow 10 CFR Part 50, Appendix A, General Design Criteria [GDCs]

for Nuclear Power Plants, which applies only to nuclear power reactors.

Nonetheless, SHINE has applied the GDCs to the preliminary design of its facility, as appropriate. As such, the Staff based its review of SHINEs principal design criteria, in part, on SHINEs application of GDCs, as described in Tables 3.5a-1 Appendix A to 10 CFR 50 General Design Criteria Which Have Been Interpreted As They Apply to the SHINE Irradiation Facility, and 3.5b-1 Baseline and General Design Criteria for Radioisotope Production Facility, of the SHINE PSAR.

The Table of Contents in the SER has been revised to reflect the above-described revisions and deletions.

B. Corrections to Responses to the Commission Pre-Hearing Questions During its hearing preparations, the Staff determined that two of its responses to pre-hearing questions, filed on November 24, 2015, need revisions to accurately reflect the Staffs views.

In its response to Pre-Hearing Question 5.a (at page 6), the Staff described radioactive releases within the irradiation unit cell, but should have referred to the target solution vessel off-gas system (TOGS) shielded cell. Thus, the words into the atmosphere of the irradiation unit cell should be deleted from the penultimate sentence in the second paragraph. Instead, that sentence should read:

The Failure of the TOGS scenario is an accident that uses more realistic assumptions for releasing the radioactive gases inside the primary system boundary into the TOGS shielded cell.

In its response to Pre-Hearing Question 18.b (at page 13), the Staff mistakenly characterized SHINEs proposed system as over-concentrated with a negative void coefficient.

The Staff, however, meant to say that the target solution is under-concentrated. Accordingly, the term over-concentrated should be replaced with under-concentrated. The revised sentence now reads, Instead, it is better to think of SHINEs proposed systems as under-concentrated with a negative void coefficient.

The changes and corrections described above are reflected in the exhibits NRC-001, NRC-002, NRC-004-R, and NRC-008 being filed today. The Staff designated only the document reflecting the revisions to the responses to Commission Pre-Hearing Questions originally filed on November 24, 2015, as Exhibit NRC-004-R. No R designation was added to the other affected exhibits inasmuch as they were not previously filed in this proceeding.

The Staff informed SHINEs counsel of the changes and corrections described above.

SHINEs counsel has no objection to the Staff modifying the exhibits as described above.

Respectfully submitted,

/Signed (electronically) by/

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 Executed in accord with 10 CFR 2.304(d)

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 8th 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-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.

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 Mirela Gavrilas Staff Presentation Slides - Safety Panel 2 (December 8, 2015).

NRC-013 Jane Marshall Staff Presentation Slides - Environmental Panel (December 8, 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 EXHIBIT LIST AND NOTICE OF REVISIONS, dated December 8, 2015, have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 8th day of December, 2015.

/Signed (electronically) by/

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 8th day of December, 2015

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