80 FR 67435 - SHINE Medical Technologies, Inc.; Notice of Hearing

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 211 (November 2, 2015)

Page Range		67435-67437
FR Document		2015-27856

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.

Federal Register, Volume 80 Issue 211 (Monday, November 2, 2015)

[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67435-67437]
From the Federal Register Online  [www.thefederalregister.org]
[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 pdr.resource@nrc.gov. 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: Denise.McGovern@nrc.gov.

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 
hearingdocket@nrc.gov.
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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

67436 Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices

II. Evidentiary Uncontested Hearing engage in the proposed activities in the State, local government body, or
The Commission will conduct this accordance with the Commission’s Indian tribe wishes the Commission to
hearing beginning at 9:00 a.m., Eastern regulations in chapter I of title 10 of the give particular attention as part of the
Time on December 15, 2015, at the CFR; (7) whether the issuance of a uncontested hearing process. Such
Commission’s headquarters in permit for the construction of the statement may be accompanied by any
Rockville, Maryland. The hearing will facility to the applicant will not, in the supporting documentation that the
continue on subsequent days, if opinion of the Commission, be inimical State, local government body, or Indian
necessary. to the common defense and security or tribe sees fit to provide. Any statements
to the health and safety of the public; and supporting documentation (if any)
III. Presiding Officer and (8) whether the application meets received by the Commission using the
The Commission is the presiding the standards and requirements of the agency’s E-filing system 1 by the
officer for this proceeding. AEA and the Commission’s regulations, deadline indicated above will be made
and that notifications, if any, to other part of the record of the proceeding. The
IV. Matters To Be Considered agencies or bodies have been duly Commission will use such statements
The matter at issue in this proceeding made. and documents as appropriate to inform
is whether the review of the SHINE CP its pre-hearing questions to the NRC
application by the Commission’s staff Issues Pursuant to the National
Environmental Policy Act (NEPA) of staff and applicant, its inquiries at the
has been adequate to support the oral hearing, and its decision following
findings found in 10 CFR 50.35, 50.40, 1969
the hearing. The Commission may also
50.50, and 10 CFR 51.105. Those With respect to the CP: (1) Determine request, prior to November 17, 2015,
findings are as follows: whether the requirements of Sections that one or more particular States, local
102(2)(A), (C), and (E) of NEPA and the government bodies, or Indian tribes
Issues Pursuant to the Atomic Energy
applicable regulations in 10 CFR part 51 send one representative each to the
Act of 1954, as Amended
have been met; (2) independently evidentiary hearing to answer
With respect to the CP: (1) Whether consider the final balance among Commission questions and/or make a
the applicant has described the conflicting factors contained in the statement for the purpose of assisting
proposed design of the facility, record of the proceeding with a view to the Commission’s exploration of one or
including, but not limited to, the determining the appropriate action to be more of the issues raised by the State,
principal architectural and engineering taken; (3) determine, after weighing the local government body, or Indian tribe,
criteria for the design, and has environmental, economic, technical, in the pre-hearing filings described
identified the major features or and other benefits against above. The decision whether to request
components incorporated therein for the environmental and other costs, and the presence of a representative of a
protection of the health and safety of the considering reasonable alternatives, State, local government body, or Indian
public; (2) whether such further whether the construction permit should tribe at the evidentiary hearing to make
technical or design information as may be issued, denied, or appropriately a statement and/or answer Commission
be required to complete the safety conditioned to protect environmental questions is solely at the Commission’s
analysis, and which can reasonably be values; and (4) determine whether the discretion. The Commission’s request
left for later consideration, will be NEPA review conducted by the NRC
supplied in the final safety analysis will specify the issue or issues that each
staff has been adequate. representative should be prepared to
report (3) whether safety features or
components, if any, which require V. Schedule for Submittal of Pre-Filed address.
research and development have been Documents Many of the procedures and rights
described by the applicant and the applicable to the inherently adversarial
No later than November 24, 2015, nature of NRC’s contested hearing
applicant has identified, and there will unless the Commission directs
be conducted, a research and process are not available in this
otherwise, the NRC staff and the uncontested hearing. Participation in
development program reasonably applicant shall submit a list of its
designed to resolve any safety questions the NRC’s contested hearing process is
anticipated witnesses for the hearing. governed by 10 CFR 2.309 (for persons
associated with such features or No later than November 24, 2015,
components; (4) whether on the basis of or entities, including a State, local
unless the Commission directs
the foregoing, there is reasonable government, or Indian tribe seeking to
otherwise, the applicant shall submit its
assurance that, (i) such safety questions file contentions of their own) and 10
pre-filed written testimony. The NRC
will be satisfactorily resolved at or CFR 2.315(c) (for an interested State,
staff submitted its pre-filed testimony
before the latest date stated in the local government, or Federally-
on October 23, 2015.
application for completion of The Commission may issue written recognized Indian tribe seeking to
construction of the proposed facility questions to the applicant or the NRC participate with respect to contentions
and (ii) taking into consideration the staff before the hearing. If such filed by others). Participation in this
site criteria contained in 10 CFR part questions are issued, an order uncontested hearing does not affect the
100, the proposed facility can be containing such questions will be issued right of a State, a local government, or
constructed and operated at the no later than November 10, 2015. an Indian tribe to participate in the
proposed location without undue risk to Responses to such questions are due separate contested hearing process.
the health and safety of the public; (5)
asabaliauskas on DSK5VPTVN1PROD with NOTICES

November 24, 2015, unless the 1 The process for accessing and using the agency’s
whether there is reasonable assurance (i) Commission directs otherwise. E-filing system is described in the March 12, 2015,
that the construction of the facility will notice of hearing (80 FR 13036) that was issued by
not endanger the health and safety of VI. Interested Government Participants
the Commission for this proceeding. Participants
the public, and (ii) that construction No later than November 9, 2015, any who are unable to use the electronic information
activities can be conducted in interested State, local government body, exchange (EIE), or who will have difficulty
complying with EIE requirements in the time frame
compliance with the Commission’s or Federally-recognized Indian tribe provided for submission of written statements, may
regulations; (6) whether the applicant is may file with the Commission a provide their statements by electronic mail to
technically and financially qualified to statement of any issues or questions that hearingdocket@nrc.gov.

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Document Created: 2018-03-01 11:30:32
Document Modified: 2018-03-01 11:30:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Construction permit application; notice of hearing.
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.
Contact		Denise McGovern, Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555- 0001, telephone: 301-415-0681; email: [email protected]
FR Citation		80 FR 67435