[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]
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