[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67435-67437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27856]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 50-608; NRC-2013-0053]
SHINE Medical Technologies, Inc.; Notice of Hearing
AGENCY: Nuclear Regulatory Commission.
ACTION: Construction permit application; notice of hearing.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission)
will convene an evidentiary session to receive testimony and exhibits
in the uncontested proceeding regarding the application from SHINE
Medical Technologies, Inc. (SHINE), for a construction permit (CP) to
construct a medical radioisotope production facility in Janesville,
Wisconsin. This mandatory hearing will consider safety and
environmental matters relating to the requested CP.
DATES: The hearing will be held on December 15, 2015, beginning at 9:00
a.m. Eastern Time. For the schedule for submitting pre-filed documents
and deadlines affecting Interested Government Participants, see Section
VI of the SUPPLEMENTARY INFORMATION section of this document.
ADDRESSES: Please refer to Docket ID 50-608 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:
NRC's Electronic Hearing Docket: You may obtain publicly
available documents related to this hearing on line at http://www.nrc.gov/about-nrc/regulatory/adjudicatory.html.
NRC's 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 ``ADAMS Public Documents,'' and
then 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 that document
is available in ADAMS) is provided the first time that a document is
referenced.
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: Denise McGovern, Office of the
Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone: 301-415-0681; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Commission hereby gives notice that, pursuant to Section 189a
of the Atomic Energy Act (AEA) of 1954, as amended (the Act), it will
convene an evidentiary session to receive testimony and exhibits in the
proceeding regarding the SHINE application for a CP under part 50 of
title 10 of the Code of Federal Regulations (10 CFR), to construct a
medical radioisotope production facility in Janesville, Wisconsin.
Part one of the SHINE's CP application was submitted by letter
dated March 26, 2013 (ADAMS Accession No. ML13088A192), and by letter
dated May 31, 2013 (ADAMS Accession No. ML13172A361), SHINE submitted
the second and final part of its two-part application for a CP. By
letter dated September 25, 2013 (ADAMS Accession No. ML13269A378),
SHINE supplemented this submission with a discussion of preliminary
plans for coping with emergencies, as required by 10 CFR 50.34(a)(10),
completing its application for a CP. The construction permit
application, including the environmental report, may be viewed in its
entirety at ADAMS Accession No. ML13172A324. This mandatory hearing
will concern safety and environmental matters relating to the requested
CP application, as more fully described below.
[[Page 67436]]
II. Evidentiary Uncontested Hearing
The Commission will conduct this hearing beginning at 9:00 a.m.,
Eastern Time on December 15, 2015, at the Commission's headquarters in
Rockville, Maryland. The hearing will continue on subsequent days, if
necessary.
III. Presiding Officer
The Commission is the presiding officer for this proceeding.
IV. Matters To Be Considered
The matter at issue in this proceeding is whether the review of the
SHINE CP application by the Commission's staff has been adequate to
support the findings found in 10 CFR 50.35, 50.40, 50.50, and 10 CFR
51.105. Those findings are as follows:
Issues Pursuant to the Atomic Energy Act of 1954, as Amended
With respect to the CP: (1) Whether the applicant has described the
proposed design of the facility, including, but not limited to, the
principal architectural and engineering criteria for the design, and
has identified the major features or components incorporated therein
for the protection of the health and safety of the public; (2) whether
such further technical or design information as may be required to
complete the safety analysis, and which can reasonably be left for
later consideration, will be supplied in the final safety analysis
report (3) whether safety features or components, if any, which require
research and development have been described by the applicant and the
applicant has identified, and there will be conducted, a research and
development program reasonably designed to resolve any safety questions
associated with such features or components; (4) whether on the basis
of the foregoing, there is reasonable assurance that, (i) such safety
questions will be satisfactorily resolved at or before the latest date
stated in the application for completion of construction of the
proposed facility and (ii) taking into consideration the site criteria
contained in 10 CFR part 100, the proposed facility can be constructed
and operated at the proposed location without undue risk to the health
and safety of the public; (5) whether there is reasonable assurance (i)
that the construction of the facility will not endanger the health and
safety of the public, and (ii) that construction activities can be
conducted in compliance with the Commission's regulations; (6) whether
the applicant is technically and financially qualified to engage in the
proposed activities in accordance with the Commission's regulations in
chapter I of title 10 of the CFR; (7) whether the issuance of a permit
for the construction of the facility to the applicant will not, in the
opinion of the Commission, be inimical to the common defense and
security or to the health and safety of the public; and (8) whether the
application meets the standards and requirements of the AEA and the
Commission's regulations, and that notifications, if any, to other
agencies or bodies have been duly made.
Issues Pursuant to the National Environmental Policy Act (NEPA) of 1969
With respect to the CP: (1) Determine whether the requirements of
Sections 102(2)(A), (C), and (E) of NEPA and the applicable regulations
in 10 CFR part 51 have been met; (2) independently consider the final
balance among conflicting factors contained in the record of the
proceeding with a view to determining the appropriate action to be
taken; (3) determine, after weighing the environmental, economic,
technical, and other benefits against environmental and other costs,
and considering reasonable alternatives, whether the construction
permit should be issued, denied, or appropriately conditioned to
protect environmental values; and (4) determine whether the NEPA review
conducted by the NRC staff has been adequate.
V. Schedule for Submittal of Pre-Filed Documents
No later than November 24, 2015, unless the Commission directs
otherwise, the NRC staff and the applicant shall submit a list of its
anticipated witnesses for the hearing.
No later than November 24, 2015, unless the Commission directs
otherwise, the applicant shall submit its pre-filed written testimony.
The NRC staff submitted its pre-filed testimony on October 23, 2015.
The Commission may issue written questions to the applicant or the
NRC staff before the hearing. If such questions are issued, an order
containing such questions will be issued no later than November 10,
2015. Responses to such questions are due November 24, 2015, unless the
Commission directs otherwise.
VI. Interested Government Participants
No later than November 9, 2015, any interested State, local
government body, or Federally-recognized Indian tribe may file with the
Commission a statement of any issues or questions that the State, local
government body, or Indian tribe wishes the Commission to give
particular attention as part of the uncontested hearing process. Such
statement may be accompanied by any supporting documentation that the
State, local government body, or Indian tribe sees fit to provide. Any
statements and supporting documentation (if any) received by the
Commission using the agency's E-filing system \1\ by the deadline
indicated above will be made part of the record of the proceeding. The
Commission will use such statements and documents as appropriate to
inform its pre-hearing questions to the NRC staff and applicant, its
inquiries at the oral hearing, and its decision following the hearing.
The Commission may also request, prior to November 17, 2015, that one
or more particular States, local government bodies, or Indian tribes
send one representative each to the evidentiary hearing to answer
Commission questions and/or make a statement for the purpose of
assisting the Commission's exploration of one or more of the issues
raised by the State, local government body, or Indian tribe, in the
pre-hearing filings described above. The decision whether to request
the presence of a representative of a State, local government body, or
Indian tribe at the evidentiary hearing to make a statement and/or
answer Commission questions is solely at the Commission's discretion.
The Commission's request will specify the issue or issues that each
representative should be prepared to address.
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\1\ The process for accessing and using the agency's E-filing
system is described in the March 12, 2015, notice of hearing (80 FR
13036) that was issued by the Commission for this proceeding.
Participants who are unable to use the electronic information
exchange (EIE), or who will have difficulty complying with EIE
requirements in the time frame provided for submission of written
statements, may provide their statements by electronic mail to
[email protected].
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Many of the procedures and rights applicable to the inherently
adversarial nature of NRC's contested hearing process are not available
in this uncontested hearing. Participation in the NRC's contested
hearing process is governed by 10 CFR 2.309 (for persons or entities,
including a State, local government, or Indian tribe seeking to file
contentions of their own) and 10 CFR 2.315(c) (for an interested State,
local government, or Federally-recognized Indian tribe seeking to
participate with respect to contentions filed by others). Participation
in this uncontested hearing does not affect the right of a State, a
local government, or an Indian tribe to participate in the separate
contested hearing process.
[[Page 67437]]
Dated at Rockville, Maryland, this 27th day of October, 2015.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2015-27856 Filed 10-30-15; 8:45 am]
BILLING CODE 7590-01-P