ML19235A308

Shine Medical Technologies, LLC - Cover Letter for Notice of Receipt and Availability of Operating License Application

ML19235A308
Person / Time
Site:	SHINE Medical Technologies
Issue date:	09/05/2019
From:	Steven Lynch Research and Test Reactors Licensing Projects Branch
To:	Piefer G SHINE Medical Technologies
Lynch S
Shared Package
ML19235A307	List: ML19235A308 ML19235A309
References
EPID L-2019-NEW-0004
Download: ML19235A308 (4)

Text

September 5, 2019 Gregory Piefer, Ph.D.

Chief Executive Officer SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - NOTICE OF RECEIPT AND AVAILABILTIY OF OPERATING LICENSE APPLICATION (EPID NO. L-2019-NEW-0004)

Dear Dr. Piefer:

By letter dated July 17, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application, which, if granted, would allow SHINE to operate its proposed Medical Isotope Production Facility in Janesville, Wisconsin. This letter serves as notification that the NRC staff has received SHINEs application and that the application is available for review at the NRCs public document room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852 and in ADAMS at Accession No. ML19211C143. Enclosed is the notice that will be forwarded to the Office of the Federal Register for publication, informing the public of the receipt and availability of the subject application.

As described in the operating license application, SHINE has proposed to construct and operate a facility for the production of molybdenum-99 (Mo-99) through the irradiation and processing of a uranyl sulfate solution. The proposed facility would comprise an irradiation facility and radioisotope production facility. The irradiation facility would consist of eight subcritical operating assemblies (or irradiation units), which would each be licensed as a utilization facility, as defined in Title 10 of the Code of Federal Regulations (10 CFR) 50.2, Definitions, and supporting structures, systems, and components (SSCs) for the irradiation of low enriched uranium. The radioisotope production facility would consist of hot cell structures, licensed collectively as a production facility, as defined in 10 CFR 50.2, and associated SSCs for the processing of irradiated material and extraction and purification of Mo-99. The irradiation facility and radioisotope production facility are collectively referred to as the SHINE Medical Isotope Production Facility. Issuance of the operating license would authorize the applicant to operate the SHINE Medical Isotope Production Facility for a 30-year period.

By letters dated March 26 and May 31, 2013 (ADAMS Accession Nos. ML13088A192 and ML13172A361, respectively), SHINE (at the time known as SHINE Medical Technologies, Inc.)

submitted a two-part construction permit application for its eight utilization facilities and one production facility. The NRC issued Construction Permit No. CPMIF-001 to SHINE on February 29, 2016 (ADAMS Accession No. ML16041A473).

In accordance with the regulations in 10 CFR 2.101, Filing of application, the NRC staff is conducting an acceptance review of the application to determine its completeness and suitability

for docketing. Should the NRC staff determine that the application is acceptable for docketing, a review schedule will be established and provided to SHINE. The NRC staff will communicate to SHINE any issues that arise during the acceptance review and notify SHINE of the results of the acceptance review by October 2019.

Please direct any questions related to the NRC staffs review of SHINEs operating license application to me at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.

Sincerely,

/RA/

Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Licensing Projects Office of Nuclear Reactor Regulation Docket No. 50-608 Construction Permit No. CPMIF-001

Enclosure:

As stated cc: w/enclosure: See next page

SHINE Medical Technologies, LLC Docket No. 50-608 cc:

Jeff Bartelme Licensing Manager SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA-23 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Shelley Warwick Environmental Analysis Specialist-South Team Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 Test, Research and Training Reactor Newsletter Attention: Ms. Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Dr.

College Park, MD 20742-2115 Mark Freitag 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

ML19235A308 -Ltr.; ML19235A309 -Encl. *concurred via e-mail NRR-106 OFFICE NRR/DLP/PRLB/PM*

NRR/DLP/PRLB/LA*

OGC*

NRR/DLP/PRLB/BC NRR/DLP/PRLB/PM NAME SLynch NParker MYoung/NLO GCasto SLynch DATE 8/23/2019 9/3/2019 8/30/2019 9/5/2019 9/5/2019