ML19102A333

Shine Medical Technologies, Inc. - Federal Register Notice Containing Order Related to Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001

ML19102A333
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/30/2019
From:	Steven Lynch Research and Test Reactors Licensing Projects Branch
To:
Lynch S, NRR/DLP.415-1524
Shared Package
ML19102A321 -Pkg.	List: ML19102A322 ML19102A323 ML19102A324 ML19102A326 ML19102A333 ML19102A348
References
NRC-2019-0029
Download: ML19102A333 (8)

Text

[7590-01-P]

NUCLEAR REGULATORY COMMISSION

[Docket No. 50-608; NRC-2019-0029]

In the Matter of SHINE Medical Technologies, Inc.

SHINE Medical Isotope Production Facility AGENCY: Nuclear Regulatory Commission.

ACTION: Indirect transfer of license; order.

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) is issuing an order approving the indirect transfer of Construction Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility, resulting from the establishment of a holding company, Illuminated Holdings, Inc. The NRC is also issuing an administrative conforming amendment to the license to reflect the transfer.

DATES: The Order was issued on May 20, 2019, and is effective for one year.

ADDRESSES: Please refer to Docket ID NRC-2019-0029 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

• Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2019-0029. Address questions about NRC Docket IDs in Regulations.gov to Jennifer Borges; telephone: 301-287-9127; e-mail:

Jennifer.Borges@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• NRCs Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the

search, select Begin Web-based ADAMS Search. For problems with ADAMS, please contact the NRCs Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to pdr.resource@nrc.gov. The license transfer Order, the NRC safety evaluation supporting the staffs findings, and the conforming license amendment are available in ADAMS under Accession Nos. ML19102A324, ML19102A326, and ML19102A322, respectively.

• NRCs PDR: You may examine and purchase copies of public documents at the NRCs PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Steven T. Lynch, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1524, e-mail: Steven.Lynch@nrc.gov.

SUPPLEMENTARY INFORMATION: The text of the Order is attached.

Dated at Rockville, Maryland, this 30th day of May 2019.

For the Nuclear Regulatory Commission.

/RA/

Steven T. Lynch, Project Manager, Research and Test Reactors Licensing Branch, Division of Licensing Projects, Office of Nuclear Reactor Regulation.

Attachment -- Order Approving the Transfer of License and Conforming Amendment UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION

[Docket No. 50-608; Construction Permit No. CPMIF-001]

In the Matter of SHINE Medical Technologies, Inc.

ORDER APPROVING THE INDIRECT TRANSFER OF LICENSE AND CONFORMING AMENDMENT I.

SHINE Medical Technologies, Inc. (SHINE) is the holder of Construction Permit No. CPMIF-001, which authorizes construction of the SHINE Medical Isotope Production Facility. SHINE has proposed to construct and operate a facility in Janesville, Wisconsin 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. The radioisotope production facility would consist of three hot cell structures, licensed collectively as a production facility, as defined in 10 CFR § 50.2.

The irradiation facility and radioisotope production facility are collectively referred to as the SHINE Medical Isotope Production Facility.

II.

By application dated December 11, 2018 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML18347A215), as supplemented by letter dated March 8, 2019 (ADAMS Accession No. ML19071A055), SHINE requested that the U.S. Nuclear Regulatory Commission (NRC, the Commission) consent to the indirect transfer of Construction Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility, currently held by SHINE. The indirect transfer would result from the establishment of a holding company, Illuminated Holdings, Inc. (Illuminated). The indirect transfer request was submitted to the NRC for approval pursuant to Section 184, Inalienability of Licenses, of the Atomic Energy Act of 1954, as amended (AEA), and 10 CFR § 50.80, Transfer of licenses.

SHINE also requested, pursuant to 10 CFR § 50.90, Application for amendment of license, construction permit, or early site permit, the issuance of an administrative conforming amendment to the license to reflect the proposed transfer. Specifically, the amendment would revise SHINEs construction permit to reflect SHINEs new name, SHINE Medical Technologies, LLC (SHINE LLC), resulting from its conversion from a corporation into a single-member limited liability company, owned and controlled by Illuminated.

Notice of NRC consideration of the indirect license transfer application was published in the Federal Register (FR) on February 20, 2019 (84 FR 5116), and included an opportunity to comment, request a hearing, and petition for leave to intervene. No comments or hearing requests were received.

Pursuant to 10 CFR § 50.80, no license for a production or utilization facility, or any right thereunder, shall be transferred, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission gives its consent in writing. Upon review of the information in the application, as supplemented, and other information before the Commission, and relying upon the representations and agreements contained in the application, as supplemented, the NRC staff has determined that SHINE LLC would be qualified to be the holder of Construction Permit No. CPMIF-001, and that the indirect transfer of the license, as described in the application, as supplemented, is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto.

Upon review of the application for a conforming amendment to Construction Permit No. CPMIF-001 to reflect the indirect transfer of the license, the NRC staff determined the following:

(1) The application for the proposed license amendment complies with the standards and requirements of the AEA, and the Commissions rules and regulations set forth in 10 CFR Chapter I, Nuclear Regulatory Commission.

(2) The facility will be constructed in conformity with the application, as supplemented, the provisions of the Act, and the rules and regulations of the Commission.

(3) There is reasonable assurance that the activities authorized by the proposed license amendment can be conducted without endangering the health and safety of the public, and that such activities will be conducted in compliance with the Commissions regulations.

(4) The issuance of the proposed license amendment will not be inimical to the common defense and security or to the health and safety of the public.

(5) The issuance of the proposed license amendment is in accordance with 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions, of the Commissions regulations, and all applicable requirements have been satisfied.

The findings set forth above are supported by an NRC safety evaluation dated May 20, 2019.

III.

Accordingly, pursuant to Sections 161b, 161i, and 184 of the AEA, Title 42 of the United States Code Sections 2201(b), 2201(i), and 2234; and 10 CFR § 50.80, IT IS HEREBY ORDERED that the application for the indirect transfer of the license, as described herein, is approved for the SHINE Medical Isotope Production Facility.

IT IS FURTHER ORDERED that, consistent with 10 CFR § 2.1315, Generic determination regarding license amendments to reflect transfers, paragraph (b), the license amendment that makes changes, as indicated in Enclosure 2 to the cover letter forwarding this Order, to conform the license to reflect the subject indirect license transfer is approved. The amendment shall be issued and made effective at the time the proposed indirect license transfer is completed.

IT IS FURTHER ORDERED that SHINE shall, at least 2 business days prior to closing, inform the Director of the Office of Nuclear Reactor Regulation in writing of the date of closing of the indirect license transfer for the SHINE Medical Isotope Production Facility. Should the proposed transfer of the license not be completed within 1 year of this Orders date of issuance, this Order shall become null and void, provided, however, that upon written application and for good cause shown, such date may be extended by order.

This Order is effective upon issuance.

For further details with respect to this Order, see the application dated December 11, 2018, as supplemented by letter dated March 8, 2019, and the associated NRC safety evaluation dated May 20, 2019, which are available for public inspection at the Commissions Public Document Room (PDR), located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland.

Publicly available documents created or received at the NRC are accessible electronically through ADAMS in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. Persons who encounter problems with ADAMS should contact the NRCs PDR reference staff by telephone at 1-800-397-4209 or 301-415-4737 or by e-mail to pdr.resource@nrc.gov.

Dated at Rockville, Maryland this 20th day of May 2019.

For the Nuclear Regulatory Commission.

/RA/

Tamara E. Bloomer, Acting Deputy Director, Division of Licensing Projects, Office of Nuclear Reactor Regulation.