[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Notices]
[Pages 55187-55188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22396]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 50-608; NRC-2019-0173]


SHINE Medical Technologies, LLC

AGENCY: Nuclear Regulatory Commission.

ACTION: Operating license application; acceptance for docketing.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff accepts and 
dockets an application submitted by SHINE Medical Technologies, LLC 
(SHINE), dated July 17, 2019, filed pursuant to the Atomic Energy Act 
of 1954, as amended, and the NRC's regulations, for an operating 
license for the SHINE Medical Isotope Production Facility.

DATES: This action takes effect on October 15, 2019.

ADDRESSES: Please refer to Docket ID NRC-2019-0173 when contacting the 
NRC about the availability of information for this action. You may 
obtain publicly-available information related to this action by any of 
the following methods:
     Federal Rulemaking Website: Go to https://www.regulations.gov/ and search for Docket ID NRC-2019-0173. Address 
questions about NRC docket IDs in Regulations.gov to Anne Frost; 
telephone: 301-287-9232; email: [email protected]. For technical

[[Page 55188]]

questions, contact the individual listed in the FOR FURTHER INFORMATION 
CONTACT section of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS 
Search.'' For problems with ADAMS, please contact the NRC's Public 
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or 
by email to [email protected]. The ADAMS accession number for each 
document referenced (if it is available in ADAMS) is provided the first 
time that it is mentioned in this document.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's 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; email: [email protected].

SUPPLEMENTARY INFORMATION: By letter dated July 17, 2019 (ADAMS 
Accession No. ML19211C044), SHINE filed with the NRC, pursuant to 
Section 103 of the Atomic Energy Act and part 50, ``Domestic Licensing 
of Production and Utilization Facilities,'' of title 10 of the Code of 
Federal Regulations (10 CFR), an application for an operating license 
for the SHINE Medical Isotope Production Facility to be located in 
Janesville, Wisconsin (ADAMS Package Accession No. ML19211C143). A 
notice of receipt and availability of this application was previously 
published in the Federal Register on September 10, 2019 (84 FR 47557).
    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. As 
described in the operating license application, 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 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, as updated in 2015, for its eight utilization 
facilities and one production facility (ADAMS Package Accession No. 
ML15258A431). The NRC issued Construction Permit No. CPMIF-001 to SHINE 
on February 29, 2016 (ADAMS Package Accession No. ML16041A473), as 
supported by NUREG-2189, ``Safety Evaluation Report Related to SHINE 
Medical Technologies, Inc. Construction Permit Application for a 
Medical Radioisotope Production Facility,'' dated August 2016, (ADAMS 
Accession No. ML16229A140) and NUREG-2183, ``Environmental Impact 
Statement for the Construction Permit for the SHINE Medical 
Radioisotope Production Facility,'' dated October 2015 (ADAMS Accession 
No. ML15288A046).
    In accordance with 10 CFR part 2, ``Agency Rules of Practice and 
Procedure,'' and part 50, the NRC staff performed an acceptance review 
of the SHINE operating license application and, by letter dated October 
8, 2019 (ADAMS Accession No. ML19276D411), concluded that the 
application is acceptable for docketing under Docket Number 50-608.
    As part of a detailed technical review of the SHINE application, 
the NRC staff will prepare and document its findings in a safety 
evaluation report. Additionally, in accordance with 10 CFR part 51, 
``Environmental Protection Regulations for Domestic Licensing and 
Related Regulatory Functions,'' the NRC staff will also prepare a 
supplemental environmental impact statement for the proposed action.
    Following additional interactions with SHINE, the NRC staff will 
establish a review schedule that identifies significant milestones and 
expected review completion date. Docketing of the application does not 
preclude the NRC staff from requesting additional information from 
SHINE as the review proceeds, nor does it predict whether the 
Commission will grant or deny the operating license.
    The application will be referred to the Advisory Committee on 
Reactor Safeguards for review and report, which will be provided to the 
Commission in accordance with 10 CFR 50.58, ``Hearings and report of 
the Advisory Committee on Reactor Safeguards.'' If the Commission finds 
that the SHINE operating license application meets the applicable 
standards of the Atomic Energy Act and the Commission's regulations, 
and that required notifications to other agencies and bodies have been 
made, the Commission will issue an operating license containing 
conditions and limitations that the Commission finds appropriate and 
necessary.
    In accordance with the provisions of 10 CFR 2.105, ``Notice of 
proposed action,'' a separate notice of opportunity to file a petition 
for leave to intervene in a hearing will be published at a later date.

    Dated at Rockville, Maryland, this 8th day of October, 2019.

    For the Nuclear Regulatory Commission.
Steven T. Lynch,
Project Manager, Research and Test Reactors Licensing Branch, Division 
of Licensing Projects, Office of Nuclear Reactor Regulation.
[FR Doc. 2019-22396 Filed 10-11-19; 8:45 am]
 BILLING CODE 7590-01-P