[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52928-52931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20622]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 50-608; NRC-2021-0140]
SHINE Medical Technologies, LLC; SHINE Medical Isotope Production
Facility
AGENCY: Nuclear Regulatory Commission.
ACTION: License amendment application; opportunity to request a hearing
and petition for leave to intervene; order imposing procedures.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is considering
issuance of an amendment to Construction Permit No. CPMIF-001, issued
to SHINE Medical Technologies, LLC, for the construction of the SHINE
Medical Isotope Production Facility. The proposed amendment would allow
the receipt and possession of certain radioactive materials necessary
for the continued construction of the SHINE Medical Isotope Production
Facility. Because this amendment request contains sensitive
unclassified non-safeguards information (SUNSI), an order imposes
procedures to obtain access to SUNSI for contention preparation.
DATES: A request for a hearing or petitions for leave to intervene must
be filed by November 22, 2021. Any potential party as defined in Sec.
2.4 of title 10 of the Code of Federal Regulations (10 CFR) who
believes access to SUNSI is necessary to respond to this notice must
request document access by October 4, 2021.
ADDRESSES: Please refer to Docket ID NRC-2021-0140 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-2021-0140. Address
questions about Docket IDs in Regulations.gov to Stacy Schumann;
telephone: 301-415-0624; email: [email protected]. For technical
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 license amendment request is
available in ADAMS under Accession No. ML21119A168.
Attention: The PDR, where you may examine and order copies
of public documents, is currently closed. You may submit your request
to the PDR via email at [email protected] or call 1-800-397-4209 or
301-415-4737, between 8:00 a.m. and 4:00 p.m. Eastern Time (ET), Monday
through Friday, except Federal holidays.
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
The NRC is considering issuance of an amendment to Construction
Permit No. CPMIF-001, issued to SHINE Medical Technologies, LLC, for
construction of the SHINE Medical Isotope Production Facility, located
in Rock County, Wisconsin.
The proposed amendment would allow the receipt and possession of
certain radioactive materials necessary for the continued construction
of the SHINE Medical Isotope Production Facility.
Before any issuance of the proposed amendment, the NRC will need to
make the findings required by the Atomic Energy Act of 1954, as amended
(the Act), and NRC's regulations.
II. Opportunity To Request a Hearing and Petition for Leave To
Intervene
Within 60 days after the date of publication of this notice, any
person (petitioner) whose interest may be affected by this action may
file a request for a hearing and petition for leave to intervene
(petition) with respect to the action. Petitions shall be filed in
accordance with the Commission's ``Agency Rules of Practice and
Procedure'' in 10 CFR part 2. Interested persons should consult 10 CFR
2.309. The NRC's regulations are accessible electronically from the NRC
Library on the NRC's website at https://www.nrc.gov/reading-rm/doc-collections/cfr/. If a petition is filed, the presiding officer will
rule on the petition and, if appropriate, a notice of a hearing will be
issued.
As required by 10 CFR 2.309(d) the petition should specifically
explain the reasons why intervention should be permitted with
particular reference to
[[Page 52929]]
the following general requirements for standing: (1) The name, address,
and telephone number of the petitioner; (2) the nature of the
petitioner's right 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 issued in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set
forth the specific contentions that the petitioner seeks to have
litigated in the proceeding. Each contention must consist of a specific
statement of the issue of law or fact to be raised or controverted. In
addition, the petitioner must provide a brief explanation of the bases
for the contention and a concise statement of the alleged facts or
expert opinions that support the contention and on which the petitioner
intends to rely at hearing. The petitioner must also provide references
to the specific sources and documents on which the petitioner intends
to rely to support its position on the issue. The petition must include
sufficient information to show that a genuine dispute exists with the
applicant or licensee on a material issue of law or fact. Contentions
must be limited to matters within the scope of the proceeding. The
contention must be one that, if proven, would entitle the petitioner to
relief. A petitioner who fails to satisfy the requirements at 10 CFR
2.309(f) with respect to 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.
Parties have the opportunity to participate fully in the conduct of the
hearing with respect to resolution of that party's admitted
contentions, including the opportunity to present evidence, consistent
with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of
publication of this notice in accordance with the filing instructions
in the ``Electronic Submissions (E-Filing'') section of this document.
Petitions and motions for leave to file new or amended contentions that
are filed after the 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)
through (iii).
A State, local governmental body, Federally recognized Indian
Tribe, or designated agency thereof, may submit a petition to the
Commission to participate as a party under 10 CFR 2.309(h) no later
than 60 days from the date of publication of this notice. The petition
must be filed in accordance with the filing instructions in the
``Electronic Submissions (E-Filing)'' section of this document, and
should meet the requirements for petitions 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. Alternatively, a State, local
governmental body, Federally recognized Indian Tribe, or agency thereof
may participate as a non-party under 10 CFR 2.315(c).
For information about filing a petition and about participation by
a person not a party under 10 CFR 2.315, see ADAMS Accession No.
ML20340A053 and on the NRC website at https://www.nrc.gov/about-nrc/regulatory/adjudicatory/hearing.html#participate.
III. Electronic Submissions (E-Filing)
All documents filed in NRC adjudicatory proceedings including
documents filed by an interested State, local governmental body,
Federally recognized Indian Tribe, or designated agency thereof that
requests to participate under 10 CFR 2.315(c), must be filed in
accordance with 10 CFR 2.302. 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,
unless an exemption permitting an alternative filing method, as
discussed below, is granted. Detailed guidance on electronic
submissions is located in the Guidance for Electronic Submissions to
the NRC (ADAMS Accession No. ML13031A056), and on the NRC website at
https://www.nrc.gov/site-help/e-submittals.html.
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 (1) request a digital identification (ID)
certificate, which allows the participant (or its counsel or
representative) to digitally sign submissions and access the E-Filing
system for any proceeding in which it is participating; and (2) advise
the Secretary that the participant will be submitting a petition or
other adjudicatory document (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 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 website at https://www.nrc.gov/site-help/e-submittals/getting-started.html. After a digital ID certificate is
obtained and a docket created, the participant must submit adjudicatory
documents in Portable Document Format. Guidance on submissions is
available on the NRC's public website at https://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the
time the document is 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. (ET) on the due date. Upon receipt of a
transmission, the E-Filing system timestamps the document and sends the
submitter an email confirming receipt of the document. The E-Filing
system also distributes an email 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 document on those
participants separately. Therefore, applicants and other participants
(or their counsel or representative) must apply for and receive a
digital ID certificate before adjudicatory documents are filed to
obtain access to the documents via the E-Filing system.
A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic
Filing Help Desk through the ``Contact Us'' link located on the NRC's
public website at https://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 Electronic Filing Help Desk is available between 9 a.m.
and 6 p.m., (ET), Monday through Friday, excluding government holidays.
Participants who believe that they have 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
stating why there is good cause for not filing electronically and
requesting authorization to continue to submit documents in paper
format. Such filings must be submitted in accordance with 10 CFR
2.302(b)-(d). Participants filing adjudicatory documents in this manner
are responsible for serving their documents on all other participants.
[[Page 52930]]
Participants granted an exemption under 10 CFR 2.302(g)(2) must still
meet the electronic formatting requirement in 10 CFR 2.302(g)(1),
unless the participant also seeks and is granted an exemption from 10
CFR 2.302(g)(1).
Documents submitted in adjudicatory proceedings will appear in the
NRC's electronic hearing docket, which is publicly available at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the
presiding officer. If you do not have an NRC-issued digital ID
certificate as described above, click ``cancel'' when the link requests
certificates and you will be automatically directed to the NRC's
electronic hearing dockets where you will be able to access any
publicly available documents in a particular hearing docket.
Participants are requested not to include personal privacy information
such as social security numbers, home addresses, or personal phone
numbers in their filings unless an NRC regulation or other law requires
submission of such information. 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
should not include copyrighted materials in their submission.
For further details with respect to this action, see the
application for amendment dated April 29, 2021.
Attorney for licensee: Nathan Schleifer, General Counsel, SHINE
Medical Technologies, LLC, 101 East Milwaukee Street, Suite 600,
Janesville, WI 53545.
NRC Branch Chief: Joshua M. Borromeo.
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 Sensitive
Unclassified Non-Safeguards Information (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 access to SUNSI. 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 requestor 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 Deputy General Counsel
for Hearings and Administration, Office of the General Counsel, U.S.
Nuclear Regulatory Commission, 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 requestor'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) the NRC staff will determine within 10 days of receipt
of the request whether:
(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
receipt of (or access to) that information. 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.
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 requisite need, the NRC staff
shall immediately notify the requestor in writing, briefly stating the
reason or reasons for the denial.
(2) The requestor 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) if another officer has been
designated to rule on information access issues, with that officer.
(3) Further appeals of decisions under this paragraph must be made
pursuant to 10 CFR 2.311.
H. Review of Grants of Access. A party other than the requestor 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 within 5 days of the notification by the
NRC staff of its grant of access and must be filed 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
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unavailable, another administrative judge, or an Administrative Law
Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another
officer has been designated to rule on information access issues, with
that officer.
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\ Requestors should note that the filing requirements of the
NRC's E-Filing Rule (72 FR 49139; August 28, 2007, as amended at 77
FR 46562; August 3, 2012) 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. The
attachment to this Order summarizes the general target schedule for
processing and resolving requests under these procedures.
It is so ordered.
Dated: September 20, 2021.
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/requestor reply).
20....................... U.S. Nuclear Regulatory Commission (NRC)
staff informs the requestor 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/requestor 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.
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 opportunity to request a hearing
and petition for leave to intervene), 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. 2021-20622 Filed 9-22-21; 8:45 am]
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