ML13233A356

Shine Medical Technologies, Inc. - Status of the Acceptance Review of Part Two of the Application for Construction Permit

ML13233A356
Person / Time
Site:	SHINE Medical Technologies
Issue date:	08/28/2013
From:	Alexander Adams Research and Test Reactors Licensing Branch
To:	Bynum R SHINE Medical Technologies
Lynch S, 301-415-1524
References
TAC MF2307
Download: ML13233A356 (4)

Text

August 28, 2013 Richard Vann Bynum, Ph.D.

Chief Operating Officer SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, INC. - STATUS OF THE ACCEPTANCE REVIEW OF PART TWO OF THE APPLICATION FOR CONSTRUCTION PERMIT (TAC NO. MF2307)

Dear Dr. Bynum:

By letter dated May 31, 2013 (SMT-2013-023, Agencywide Documents Access and Management System (ADAMS) Accession No. ML13172A361), SHINE Medical Technologies, Inc. (SHINE), submitted the second and final part of its two-part application for a construction permit. If granted, the construction permit would allow SHINE to construct a medical radioisotope production facility to be located in Janesville, Wisconsin.

SHINE submitted part one of the construction permit application by letter dated March 26, 2013 (ADAMS Accession No. ML13088A192). The U.S. Nuclear Regulatory Commission (NRC) staff acknowledged receipt of this partial application for a construction permit under Title 10 of the Code of Federal Regulations (10 CFR), Part 50, Domestic Licensing of Production and Utilization Facilities, in the Federal Register (FR) (78 FR 29390) on May 20, 2013. An exemption from certain requirements of 10 CFR 2.101(a)(5) granted by the Commission on March 20, 2013 (ADAMS Accession No. ML13072B195), in response to a letter from SHINE dated February 18, 2013 (ADAMS Accession No. ML13051A007), allowed SHINE to submit its construction permit application in two parts. Specifically, the exemption allowed SHINE to submit a portion of its application for a construction permit up to six months prior to the remainder of the application regardless of whether or not an environmental impact statement or a supplement to an environmental impact statement is prepared during the review of its application. In accordance with 10 CFR 2.101(a)(5), SHINE submitted the following in part one of its construction permit application:

the description and safety assessment of the site required by 10 CFR 50.34(a)(1) the environmental report required by 10 CFR 50.30(f) the filing fee information required by 10 CFR 50.30(e) and 10 CFR 170.21 the general information required by 10 CFR 50.33 the agreement limiting access to classified information required by 10 CFR 50.37 As stated in your March 26, 2013, letter, part two of SHINEs application for a construction permit was to contain the remainder of the preliminary safety analysis report (PSAR) required by 10 CFR 50.34(a) and would be submitted in accordance with the requirements of 10 CFR 2.101(a)(5).

NRC staff is nearing completion of its acceptance review of part two of SHINEs application for a construction permit and has identified an apparent deficiency in the application. Specifically, SHINE did not provide a discussion of preliminary plans for coping with emergencies, as required by 10 CFR 50.34(a)(10). Requirements for this plan are set forth in Appendix E to 10 CFR Part 50, Emergency Planning and Preparedness for Production and Utilization Facilities.

Meeting regulatory requirements, with respect to the information necessary to be submitted to support a construction permit application, as outlined in applicable NRC regulations, is the principal focus of the NRC staffs acceptance review. If required information is not submitted, SHINEs application for a construction permit will be considered incomplete and unacceptable for docketing. Therefore, the NRC staff requests that SHINE provide a preliminary plan for coping with emergencies, as required by 10 CFR 50.34(a)(10), within 30 days of the date of this letter.

Should SHINE be unable to provide this information within the 30-day timeframe, the staff will consider the application incomplete and unacceptable for docketing. In the event that such a determination is made, SHINE will be notified of the decision and be provided the opportunity to withdraw, supplement, or resubmit its application for a construction permit. Part two of SHINEs application for a construction permit will be accepted for docketing and a detailed technical review only when the NRC staff has determined that the tendered application includes all information required by applicable regulatory requirements.

If you have any questions, please contact Steven Lynch at Steven.Lynch@nrc.gov or 301-415-1524.

Sincerely,

/RA/

Alexander Adams, Jr., Chief Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-608 cc: See next page

cc:

Jim Costedio Licensing Manager SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713 Cindy Atkins-Duffin, Ph.D.

Senior Policy Analyst Office of Science and Technology Policy Executive Office Building 1650 Pennsylvania Avenue Washington, D.C. 20503 Joan Dix National Nuclear Security Administration, NA-212 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Cheryl Rogers Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Amanda Cushman Environmental Analysis and Review Specialist State of Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611 Jacob Winzenz Acting City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546

ML13233A356

• concurrence via e-mail NRR-106 OFFICE NRR/DPR/PRLB/PM NRR/DPR/PRLB/LA OGC NRR/PRLB/BC NAME SLynch PBlechman SPrice*

AAdams DATE 8/21/13 8/21/13 8/28/13 8/28/13