ML16021A194

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Official Exhibit - NRC-014-MA-CM01 - NRC Staff Responses to Post-Hearing Questions
ML16021A194
Person / Time
Site: SHINE Medical Technologies
Issue date: 12/29/2015
From:
NRC/OGC
To:
NRC/OCM
SECY RAS
References
Mandatory Hearing 2, RAS 28716, SHINE Medical Technologies M-50-608-CP
Download: ML16021A194 (3)
v • d • e


Text

NRC-014 United States Nuclear Regulatory Commission Official Hearing Exhibit UNITED STATES OF AMERICA In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.

NUCLEAR REGULATORY COMMISSION (Medical Radioisotope Production Facility)

BEFORE THE COMMISSION In the Matter of )

Commission Mandatory Hearing

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP Docket #: 05000608

)

(Medical Radioisotope Production Facility) )

)

Exhibit #: NRC-014-MA-CM01 Identified: 12/29/2015 NRC STAFF RESPONSES TO POST-HEARING QUESTIONS Admitted: 01/14/2016 Withdrawn:

Pursuant to the Commission Order (Transmitting Post-Hearing Questions), dated December 21, 2015, the U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby Rejected: Stricken:

responds to the questions posed by that Order. Other:

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 29th day of December, 2015

NRC STAFF RESPONSES to POST-HEARING QUESTIONS

1. Please provide an estimate of the total number of hours the Staff spent reviewing the application for a construction permit from SHINE Medical Technologies and engaging in other activities directly in support of this review.

Staff Response: The Staff spent approximately 16,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> reviewing the SHINE construction permit application and engaging in other activities directly in support of this review.

Review and support activities included: the technical review, including the development of requests for additional information, the Safety Evaluation Report, and the Environmental Impact Statement; project management; participation in public meetings; regulatory analysis and correspondence; and rule development. In addition, contractors provided approximately 6,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> in support of the Staffs review.

2. In its response to pre-hearing Question 41, SHINE described the bulk effects of a dilution event caused by a breach between the target solution vessel and the primary closed-loop cooling system. Has SHINE considered what would happen locally at the leak location? How would this affect the local reactivity until the solution is well mixed? Will the SHINE leak detection systems identify a slow leak in a reasonable time?

Staff Response: None. This question was directed to the Applicant.

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 RESPONSES TO POST-HEARING QUESTIONS, dated December 29, 2015, have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 29th 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 29th day of December, 2015

NRC-014 United States Nuclear Regulatory Commission Official Hearing Exhibit UNITED STATES OF AMERICA In the Matter of: SHINE MEDICAL TECHNOLOGIES, INC.

NUCLEAR REGULATORY COMMISSION (Medical Radioisotope Production Facility)

BEFORE THE COMMISSION In the Matter of )

Commission Mandatory Hearing

)

SHINE MEDICAL TECHNOLOGIES, INC. ) Docket No. M-50-608-CP Docket #: 05000608

)

(Medical Radioisotope Production Facility) )

)

Exhibit #: NRC-014-MA-CM01 Identified: 12/29/2015 NRC STAFF RESPONSES TO POST-HEARING QUESTIONS Admitted: 01/14/2016 Withdrawn:

Pursuant to the Commission Order (Transmitting Post-Hearing Questions), dated December 21, 2015, the U.S. Nuclear Regulatory Commission (NRC) staff (Staff) hereby Rejected: Stricken:

responds to the questions posed by that Order. Other:

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 29th day of December, 2015

NRC STAFF RESPONSES to POST-HEARING QUESTIONS

1. Please provide an estimate of the total number of hours the Staff spent reviewing the application for a construction permit from SHINE Medical Technologies and engaging in other activities directly in support of this review.

Staff Response: The Staff spent approximately 16,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> reviewing the SHINE construction permit application and engaging in other activities directly in support of this review.

Review and support activities included: the technical review, including the development of requests for additional information, the Safety Evaluation Report, and the Environmental Impact Statement; project management; participation in public meetings; regulatory analysis and correspondence; and rule development. In addition, contractors provided approximately 6,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> in support of the Staffs review.

2. In its response to pre-hearing Question 41, SHINE described the bulk effects of a dilution event caused by a breach between the target solution vessel and the primary closed-loop cooling system. Has SHINE considered what would happen locally at the leak location? How would this affect the local reactivity until the solution is well mixed? Will the SHINE leak detection systems identify a slow leak in a reasonable time?

Staff Response: None. This question was directed to the Applicant.

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 RESPONSES TO POST-HEARING QUESTIONS, dated December 29, 2015, have been served upon the Electronic Information Exchange, the NRCs E-Filing System, in the above-captioned proceeding, this 29th 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 29th day of December, 2015

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