[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13036-13040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05672]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 50-608; NRC-2013-0053]
SHINE Medical Technologies, Inc.; Notice of Hearing, Opportunity
To Intervene, Order Imposing Procedures
AGENCY: Nuclear Regulatory Commission.
ACTION: Construction permit application; hearing, opportunity to
petition for leave to intervene; order imposing procedures for access
to Sensitive Unclassified Non-Safeguards Information (SUNSI).
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received a
construction permit application from SHINE Medical Technologies, Inc.
(SHINE), for approval of a proposed medical radioisotope production
facility for the production of molybdenum-99 (Mo-99) at a site located
in Janesville, Wisconsin. The NRC is currently conducting a detailed
technical review of the construction permit application. If the
construction permit application is approved, the applicant would be
authorized to construct its proposed medical radioisotope production
facility in accordance with the provisions of the construction permit.
DATES: A petition for leave to intervene must be filed by May 11, 2015.
ADDRESSES: Please refer to Docket Number 50-608 or Docket ID NRC-2013-
0053 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 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 in this document
(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: Steven Lynch, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone: 301-415-1524, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
By letters dated March 26, 2013 (ADAMS Accession No. ML13088A192),
and May 31, 2013 (ADAMS Accession No. ML13172A361), and supplemented by
letter dated September 25, 2013 (ADAMS Accession No. ML13269A378),
SHINE requested approval of a construction permit application for a
medical radioisotope production facility (ADAMS Accession No.
ML13172A324). SHINE's medical radioisotope production facility would
include an irradiation facility and a radioisotope production facility
collocated in a single building. The irradiation facility would consist
of accelerator-driven subcritical operating assemblies used for the
irradiation of a uranium solution to produce molybdenum-99 and other
fission products. The radioisotope production facility would consist of
hot cell structures used for the extraction of radioisotopes. Part one
of the application was accepted for docketing on June 25, 2013 (78 FR
39342). The second and final portion of SHINE's two-part construction
permit application, as supplemented, was accepted for docketing on
December 2, 2013 (78 FR 73897). The docket number established for this
application is 50-608.
The NRC is considering issuance of a construction permit to SHINE
for construction of the SHINE medical radioisotope production facility,
to be located in Rock County, Wisconsin.
II. Hearing
Pursuant to the Atomic Energy Act of 1954, as amended, and parts 2
and 50 of Title 10 of the Code of Federal Regulations (10 CFR), ``Rules
of Practice for Domestic Licensing Proceedings and Issuance of
Orders,'' and ``Domestic Licensing of Production and Utilization
Facilities,'' notice is hereby given that a hearing will be held, at a
time and place to be set in the future by the Commission or designated
by the Atomic Safety and Licensing Board (Board).
The hearing on the application for a construction permit filed by
SHINE pursuant to 10 CFR part 50 will be conducted by a Board that will
be designated by the Chief Judge of the Atomic Safety and Licensing
Board Panel or will be conducted by the Commission. Notice as to the
membership of the Board will be published in the Federal Register at a
later date. The NRC staff will complete a detailed technical review of
the application and will document its findings in a safety evaluation
report. The Commission will refer a copy of the application to the
Advisory Committee on Reactor Safeguards (ACRS) in accordance with 10
CFR 50.58, ``Hearings and Report of the Advisory Committee on Reactor
Safeguards,'' and the ACRS will report on those portions of the
application that concern safety. The NRC staff will also complete an
environmental review of the application and will document its findings
in an environmental impact statement in accordance with the National
Environmental Policy Act of 1969, as amended, and the Commission's
regulations in 10 CFR part 51.
III. Opportunity To Petition for Leave To Intervene
Within 60 days after the date of publication of this Federal
Register notice, any person whose interest may be affected by this
proceeding and who desires to participate as a party in this proceeding
must file a written petition for leave to intervene with respect to
issuance of the construction permit to SHINE in accordance with the
NRC's ``Agency Rules of Practice and Procedure'' in 10 CFR part 2.
Interested
[[Page 13037]]
person(s) should consult a current copy of 10 CFR 2.309, which is
available at the NRC's PDR. The NRC's regulations are accessible
electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/.
As required by 10 CFR 2.309, a petition for leave to intervene must
set forth with particularity the interest of the petitioner in the
proceeding and how that interest may be affected by the results of the
proceeding. The petition must specifically explain the reasons why
intervention should be permitted, with particular reference to the
following general requirements: (1) the name, address, and telephone
number of the petitioner; (2) the nature of the petitioner's right
under the Act to be made a party to the proceeding; (3) the nature and
extent of the petitioner's property, financial, or other interest in
the proceeding; and (4) the possible effect of any decision or order
which may be entered in the proceeding on the petitioner's interest.
The petition must also include the specific contentions that the
petitioner seeks to have litigated at the proceeding.
For each contention, the petitioner must provide a specific
statement of the issue of law or fact to be raised or controverted, as
well as a brief explanation of the basis for the contention.
Additionally, the petitioner must demonstrate that the issue raised by
each contention is within the scope of the proceeding and is material
to the findings that the NRC must make to support the issuance of the
construction permit in response to the application. The petition must
also include a concise statement of the alleged facts or expert opinion
that support the contention and on which the petitioner intends to rely
at the hearing, together with references to those specific sources and
documents. The petition must provide sufficient information to show
that a genuine dispute exists with the applicant on a material issue of
law or fact. Contentions shall be limited to matters within the scope
of the licensing action under consideration. Each contention must be
one which, if proven, would entitle the petitioner to relief. A
petitioner who does not satisfy these requirements for at least one
contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding,
subject to any limitations in the order granting leave to intervene,
and have the opportunity to participate fully in the conduct of the
hearing with respect to resolution of that person's admitted
contentions, including the opportunity to present evidence and to
submit a cross-examination plan for cross-examination of witnesses,
consistent with NRC regulations, policies, and procedures. The Atomic
Safety and Licensing Board will set the time and place for any
prehearing conferences and evidentiary hearings, and the appropriate
notices will be provided.
Petitions for leave to intervene must be filed no later than 60
days from the date of publication of this notice. Petitions for leave
to intervene and motions for leave to file new or amended contentions
that are filed after the 60-day deadline will not be entertained absent
a determination by the presiding officer that the filing demonstrates
good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-
(iii).
A State, local governmental body, Federally-recognized Indian
Tribe, or agency thereof, may submit a petition to the Commission to
participate as a party under 10 CFR 2.309(h)(1). The petition should
state the nature and extent of the petitioner's interest in the
proceeding. The petition should be submitted to the Commission by May
11, 2015. The petition must be filed in accordance with the filing
instructions in the ``Electronic Submission (E-Filing)'' section of
this document, and should meet the requirements for petitions for leave
to intervene set forth in this section, except that under 10 CFR
2.309(h)(2) a State, local governmental body, or Federally-recognized
Indian Tribe, or agency thereof does not need to address the standing
requirements in 10 CFR 2.309(d) if the facility is located within its
boundaries. A State, local governmental body, Federally-recognized
Indian Tribe, or agency thereof may also have the opportunity to
participate under 10 CFR 2.315(c).
Any person who files a motion pursuant to 10 CFR 2.323 must consult
with counsel for the applicant and counsel for the NRC staff. Counsel
for the applicant is Paul Bessette, [email protected], 202-739-
5796. Counsel for the NRC staff in this proceeding is Mitzi Young,
[email protected], 301-415-3830.
Any person who does not wish, or is not qualified, to become a
party to the proceeding may, in the discretion of the presiding
officer, be permitted to make a limited appearance pursuant to the
provisions of 10 CFR 2.315(a). A person making a limited appearance may
make an oral or written statement of position on the issues, but may
not otherwise participate in the proceeding. A limited appearance may
be made at any session of the hearing or at any prehearing conference,
subject to the limits and conditions as may be imposed by the presiding
officer. Persons desiring to make a limited appearance are requested to
inform the Secretary of the Commission by May 11, 2015.
IV. Electronic Submissions (E-Filing)
All documents filed in NRC adjudicatory proceedings, including a
request for hearing, a petition for leave to intervene, any motion or
other document filed in the proceeding prior to the submission of a
request for hearing or petition to intervene, and documents filed by
interested governmental entities participating under 10 CFR 2.315(c),
must be filed in accordance with the NRC's E-Filing rule (72 FR 49139;
August 28, 2007). The E-Filing process requires participants to submit
and serve all adjudicatory documents over the internet, or in some
cases to mail copies on electronic storage media. Participants may not
submit paper copies of their filings unless they seek an exemption in
accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10
days prior to the filing deadline, the participant should contact the
Office of the Secretary by email at [email protected], or by
telephone at 301-415-1677, to request: (1) a digital identification
(ID) certificate, which allows the participant (or its counsel or
representative) to digitally sign documents and access the E-Submittal
server for any proceeding in which it is participating; and (2) advise
the Secretary that the participant will be submitting a request or
petition for hearing (even in instances in which the participant, or
its counsel or representative, already holds an NRC-issued digital ID
certificate). Based upon this information, the Secretary will establish
an electronic docket for the hearing in this proceeding if the
Secretary has not already established an electronic docket.
Information about applying for a digital ID certificate is
available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. System requirements for accessing
the E-Submittal server are detailed in the NRC's ``Guidance for
Electronic Submission,'' which is available on the agency's public Web
site at http://www.nrc.gov/site-help/e-submittals.html. Participants
may attempt to use other software not listed on the Web site, but
should note that the NRC's E-Filing system does not support unlisted
software, and the NRC Meta System Help Desk will not be able to
[[Page 13038]]
offer assistance in using unlisted software.
If a participant is electronically submitting a document to the NRC
in accordance with the E-Filing rule, the participant must file the
document using the NRC's online, Web-based submission form. In order to
serve documents through the Electronic Information Exchange System,
users will be required to install a Web browser plug-in from the NRC's
Web site. Further information on the Web-based submission form,
including the installation of the Web browser plug-in, is available on
the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html.
Once a participant has obtained a digital ID certificate and a
docket has been created, the participant can then submit a request for
hearing or petition for leave to intervene. Submissions should be in
Portable Document Format (PDF) in accordance with NRC guidance
available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the
documents are submitted through the NRC's E-Filing system. To be
timely, an electronic filing must be submitted to the E-Filing system
no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of
a transmission, the E-Filing system time-stamps the document and sends
the submitter an email notice confirming receipt of the document. The
E-Filing system also distributes an email notice that provides access
to the document to the NRC's Office of the General Counsel and any
others who have advised the Office of the Secretary that they wish to
participate in the proceeding, so that the filer need not serve the
documents on those participants separately. Therefore, applicants and
other participants (or their counsel or representative) must apply for
and receive a digital ID certificate before a hearing request/petition
to intervene is filed so that they can obtain access to the document
via the E-Filing system.
A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC Meta System
Help Desk through the ``Contact Us'' link located on the NRC's public
Web site at http://www.nrc.gov/site-help/e-submittals.html, by email to
[email protected], or by a toll-free call at 1-866-672-7640. The
NRC Meta System Help Desk is available between 8 a.m. and 8 p.m.,
Eastern Time, Monday through Friday, excluding government holidays.
Participants who believe that they have a good cause for not
submitting documents electronically must file an exemption request, in
accordance with 10 CFR 2.302(g), with their initial paper filing
requesting authorization to continue to submit documents in paper
format. Such filings must be submitted by: (1) First class mail
addressed to the Office of the Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention:
Rulemaking and Adjudications Staff; or (2) courier, express mail, or
expedited delivery service to the Office of the Secretary, Sixteenth
Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland
20852, Attention: Rulemaking and Adjudications Staff. Participants
filing a document in this manner are responsible for serving the
document on all other participants. Filing is considered complete by
first-class mail as of the time of deposit in the mail, or by courier,
express mail, or expedited delivery service upon depositing the
document with the provider of the service. A presiding officer, having
granted an exemption request from using E-Filing, may require a
participant or party to use E-Filing if the presiding officer
subsequently determines that the reason for granting the exemption from
use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the
NRC's electronic hearing docket which is available to the public at
http://ehd1.nrc.gov/ehd/, unless excluded pursuant to an order of the
Commission, or the presiding officer. Participants are requested not to
include personal privacy information, such as social security numbers,
home addresses, or home phone numbers in their filings, unless an NRC
regulation or other law requires submission of such information.
However, a request to intervene will require including information on
local residence in order to demonstrate a proximity assertion of
interest in the proceeding. With respect to copyrighted works, except
for limited excerpts that serve the purpose of the adjudicatory filings
and would constitute a Fair Use application, participants are requested
not to include copyrighted materials in their submissions.
V. Order Imposing Procedures for Access to Sensitive Unclassified Non-
Safeguards Information for Contention Preparation
A. This Order contains instructions regarding how potential parties
to this proceeding may request access to documents containing SUNSI.
B. Within 10 days after publication of this notice of hearing and
opportunity to petition for leave to intervene, any potential party who
believes access to SUNSI is necessary to respond to this notice may
request such access. A ``potential party'' is any person who intends to
participate as a party by demonstrating standing and filing an
admissible contention under 10 CFR 2.309. Requests for access to SUNSI
submitted later than 10 days after publication of this notice will not
be considered absent a showing of good cause for the late filing,
addressing why the request could not have been filed earlier.
C. The requester shall submit a letter requesting permission to
access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, Attention: Rulemakings and
Adjudications Staff, and provide a copy to the Associate General
Counsel for Hearings, Enforcement and Administration, Office of the
General Counsel, Washington, DC 20555-0001. The expedited delivery or
courier mail address for both offices is: U.S. Nuclear Regulatory
Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email
address for the Office of the Secretary and the Office of the General
Counsel are [email protected] and [email protected],
respectively.\1\ The request must include the following information:
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\1\ While a request for hearing or petition to intervene in this
proceeding must comply with the filing requirements of the NRC's
``E-Filing Rule,'' the initial request to access SUNSI under these
procedures should be submitted as described in this paragraph.
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(1) A description of the licensing action with a citation to this
Federal Register notice;
(2) The name and address of the potential party and a description
of the potential party's particularized interest that could be harmed
by the action identified in C.(1); and
(3) The identity of the individual or entity requesting access to
SUNSI and the requester's basis for the need for the information in
order to meaningfully participate in this adjudicatory proceeding. In
particular, the request must explain why publicly-available versions of
the information requested would not be sufficient to provide the basis
and specificity for a proffered contention.
D. Based on an evaluation of the information submitted under
paragraph C.(3) above, the NRC staff will determine within 10 days of
receipt of the request whether:
[[Page 13039]]
(1) There is a reasonable basis to believe the petitioner is likely
to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to
SUNSI.
E. If the NRC staff determines that the requestor satisfies both
D.(1) and D.(2) above, the NRC staff will notify the requestor in
writing that access to SUNSI has been granted. The written notification
will contain instructions on how the requestor may obtain copies of the
requested documents, and any other conditions that may apply to access
to those documents. These conditions may include, but are not limited
to, the signing of a Non-Disclosure Agreement or Affidavit, or
Protective Order \2\ setting forth terms and conditions to prevent the
unauthorized or inadvertent disclosure of SUNSI by each individual who
will be granted access to SUNSI.
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\2\ Any motion for Protective Order or draft Non-Disclosure
Affidavit or Agreement for SUNSI must be filed with the presiding
officer or the Chief Administrative Judge if the presiding officer
has not yet been designated, within 30 days of the deadline for the
receipt of the written access request.
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F. Filing of Contentions. Any contentions in these proceedings that
are based upon the information received as a result of the request made
for SUNSI must be filed by the requestor no later than 25 days after
the requestor is granted access to that information. However, if more
than 25 days remain between the date the petitioner is granted access
to the information and the deadline for filing all other contentions
(as established in the notice of hearing or opportunity for hearing),
the petitioner may file its SUNSI contentions by that later deadline.
This provision does not extend the time for filing a request for a
hearing and petition to intervene, which must comply with the
requirements of 10 CFR 2.309.
G. Review of Denials of Access.
(1) If the request for access to SUNSI is denied by the NRC staff
after a determination on standing and need for access, the NRC staff
shall immediately notify the requestor in writing, briefly stating the
reason or reasons for the denial.
(2) The requester may challenge the NRC staff's adverse
determination by filing a challenge within 5 days of receipt of that
determination with: (a) The presiding officer designated in this
proceeding; (b) if no presiding officer has been appointed, the Chief
Administrative Judge, or if he or she is unavailable, another
administrative judge, or an administrative law judge with jurisdiction
pursuant to 10 CFR 2.318(a); or (c) officer if that officer has been
designated to rule on information access issues.
H. Review of Grants of Access. A party other than the requester may
challenge an NRC staff determination granting access to SUNSI whose
release would harm that party's interest independent of the proceeding.
Such a challenge must be filed with the Chief Administrative Judge
within 5 days of the notification by the NRC staff of its grant of
access.
If challenges to the NRC staff determinations are filed, these
procedures give way to the normal process for litigating disputes
concerning access to information. The availability of interlocutory
review by the Commission of orders ruling on such NRC staff
determinations (whether granting or denying access) is governed by 10
CFR 2.311.\3\
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\3\ Requesters should note that the filing requirements of the
NRC's E-Filing Rule (72 FR 49139; August 28, 2007) apply to appeals
of NRC staff determinations (because they must be served on a
presiding officer or the Commission, as applicable), but not to the
initial SUNSI request submitted to the NRC staff under these
procedures.
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I. The Commission expects that the NRC staff and presiding officers
(and any other reviewing officers) will consider and resolve requests
for access to SUNSI, and motions for protective orders, in a timely
fashion in order to minimize any unnecessary delays in identifying
those petitioners who have standing and who have propounded contentions
meeting the specificity and basis requirements in 10 CFR part 2.
Attachment 1 to this Order summarizes the general target schedule for
processing and resolving requests under these procedures.
It is so ordered.
Dated at Rockville, Maryland, this 4th of March, 2015.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
Attachment 1--General Target Schedule for Processing and Resolving
Requests for Access to Sensitive Unclassified Non-Safeguards Information
in This Proceeding
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Day Event/Activity
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0........................ Publication of Federal Register notice of
hearing and opportunity to petition for
leave to intervene, including order with
instructions for access requests.
10....................... Deadline for submitting requests for access
to Sensitive Unclassified Non-Safeguards
Information (SUNSI) with information:
Supporting the standing of a potential party
identified by name and address; describing
the need for the information in order for
the potential party to participate
meaningfully in an adjudicatory proceeding.
60....................... Deadline for submitting petition for
intervention containing: (i) Demonstration
of standing; and (ii) all contentions whose
formulation does not require access to SUNSI
(+25 Answers to petition for intervention;
+7 petitioner reply).
20....................... U.S. Nuclear Regulatory Commission (NRC)
staff informs the requester of the staff's
determination whether the request for access
provides a reasonable basis to believe
standing can be established and shows need
for SUNSI. (NRC staff also informs any party
to the proceeding whose interest independent
of the proceeding would be harmed by the
release of the information.) If NRC staff
makes the finding of need for SUNSI and
likelihood of standing, NRC staff begins
document processing (preparation of
redactions or review of redacted documents).
25....................... If NRC staff finds no ``need'' or no
likelihood of standing, the deadline for
petitioner/requester to file a motion
seeking a ruling to reverse the NRC staff's
denial of access; NRC staff files copy of
access determination with the presiding
officer (or Chief Administrative Judge or
other designated officer, as appropriate).
If NRC staff finds ``need'' for SUNSI, the
deadline for any party to the proceeding
whose interest independent of the proceeding
would be harmed by the release of the
information to file a motion seeking a
ruling to reverse the NRC staff's grant of
access.
30....................... Deadline for NRC staff reply to motions to
reverse NRC staff determination(s).
40....................... (Receipt +30) If NRC staff finds standing and
need for SUNSI, deadline for NRC staff to
complete information processing and file
motion for Protective Order and draft Non-
Disclosure Affidavit. Deadline for applicant/
licensee to file Non-Disclosure Agreement
for SUNSI.
A........................ If access granted: Issuance of presiding
officer or other designated officer decision
on motion for protective order for access to
sensitive information (including schedule
for providing access and submission of
contentions) or decision reversing a final
adverse determination by the NRC staff.
[[Page 13040]]
A + 3.................... Deadline for filing executed Non-Disclosure
Affidavits. Access provided to SUNSI
consistent with decision issuing the
protective order.
A + 28................... Deadline for submission of contentions whose
development depends upon access to SUNSI.
However, if more than 25 days remain between
the petitioner's receipt of (or access to)
the information and the deadline for filing
all other contentions (as established in the
notice of hearing or opportunity for
hearing), the petitioner may file its SUNSI
contentions by that later deadline.
A + 53................... (Contention receipt +25) Answers to
contentions whose development depends upon
access to SUNSI.
A + 60................... (Answer receipt +7) Petitioner/Intervenor
reply to answers.
>A + 60.................. Decision on contention admission.
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[FR Doc. 2015-05672 Filed 3-11-15; 8:45 am]
BILLING CODE 7590-01-P