[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75297-75299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26666]


-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[Docket No. 50-608; NRC-2022-0180]


In the Matter of SHINE Medical Technologies, LLC; SHINE Medical 
Isotope Production Facility

AGENCY: Nuclear Regulatory Commission.

ACTION: Order; issuance.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has approved the 
SHINE Medical Technologies, LLC (SHINE) request to amend Construction 
Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility 
(SHINE facility) in Rock County, Wisconsin. The approved amendments 
extend the latest date for completion of the construction of the SHINE 
facility from December 31, 2022, to December 31, 2025, and 
administratively change the name of the construction permit holder from 
SHINE Medical Technologies, LLC to SHINE Technologies, LLC.

DATES: The Order was issued on November 30, 2022.

ADDRESSES: Please refer to Docket ID NRC-2022-0180 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:
     Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0180. 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 SHINE request to amend 
Construction Permit No. CPMIF-001 is available in ADAMS under Accession 
No. ML22091A093.
     NRC's PDR: You may examine and purchase copies of public 
documents, by appointment, at the NRC's PDR, Room P1 B35, One White 
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make 
an appointment to visit the PDR, please send an email to 
[email protected] or call 1-800-397-4209 or 301-415-4737, between 
8:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except 
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Holly Cruz, Office of Nuclear Reactor 
Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001; telephone: 301-415-1053; email: [email protected].

SUPPLEMENTARY INFORMATION: The text of the Order is attached.

    Dated: December 5, 2022.


[[Page 75298]]


    For the Nuclear Regulatory Commission.
Joshua M. Borromeo,
Chief, Non-Power Production and Utilization Facilities Licensing 
Branch, Division of Advanced Reactors and Non-Power Production and 
Utilization Facilities, Office of Nuclear Reactor Regulation.

United States of America

Nuclear Regulatory Commission

    In the Matter of: SHINE Medical Technologies, LLC (SHINE Medical 
Isotope Production Facility)

Docket No. 50-608
Construction Permit No. CPMIF-001

Order

I.

    SHINE Medical Technologies, LLC (SHINE, licensee, permit holder) 
is the holder of Construction Permit (CP) No. CPMIF-001, which the 
U.S. Nuclear Regulatory Commission (NRC, the Commission) issued on 
February 29, 2016 (Agencywide Documents Access and Management System 
(ADAMS) Package Accession No. ML16041A473), for the construction of 
the SHINE Medical Isotope Production Facility (SHINE facility) in 
Rock County, Wisconsin. CP No. CPMIF-001 includes December 31, 2022 
as the latest date for completion of the construction of the SHINE 
facility and expires on the latest date of completion. The SHINE 
facility is currently under construction.
    By letter dated April 1, 2022 (ML22091A093), SHINE submitted to 
the NRC a license amendment request in accordance with section 
50.90, ``Application for amendment of license, construction permit, 
or early site permit,'' of title 10 of the Code of Federal 
Regulations (10 CFR) and 10 CFR 50.55(b). The license amendment 
request seeks to extend the latest date for completion of the 
construction of the SHINE facility from December 31, 2022, to 
December 31, 2025, and to change the name of the CP holder from 
SHINE Medical Technologies, LLC to SHINE Technologies, LLC. SHINE 
stated that the proposed name change is administrative because it 
does not involve any transfer of control of the CP or a change to 
ownership, organization, rights, or liabilities of SHINE.

II.

    Upon review of the license amendment request, the NRC staff 
determined that SHINE had shown good cause for extending the latest 
date for completion of the construction of the SHINE facility from 
December 31, 2022, to December 31, 2025 and that the name change of 
the CP holder from SHINE Medical Technologies, LLC to SHINE 
Technologies, LLC is administrative in nature. The staff also 
determined that the license amendment request involves no 
significant hazards consideration. The staff prepared an 
environmental assessment and finding of no significant impact for 
the requested extension of the latest date for completion of 
construction and published it in the Federal Register on November 
10, 2022 (87 FR 67965). On the basis of the environmental 
assessment, the staff concluded that the requested extension will 
not have a significant effect on the quality of the human 
environment. The findings set forth above are supported by an NRC 
staff safety evaluation dated November 30, 2022, which is available 
at ML22292A319.

III.

    Within 60 days after the date of publication of this notice, any 
persons (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. The scope of this order 
extending the latest date for completion of construction and 
administratively changing the name of the CP holder and any 
proceeding hereunder is limited to direct challenges to the CP 
holder's asserted reasons that show good cause for the extension and 
to the name change. 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 a current copy of 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/doccollections/cfr/. Alternatively, a copy of the regulations is 
available at the NRC's Public Document Room, located at One White 
Flint North, Room P1 B35, 11555 Rockville Pike, Rockville, Maryland 
20852. If a petition is filed, the Commission or a 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 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 entered 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 which 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 opinion which support the contention 
and on which the petitioner intends to rely in proving the 
contention at the 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 which, 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. 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). The petition must be 
filed in accordance with the filing instructions in the section of 
this document discussing electronic submissions (E-Filing).
    If a hearing is requested, and the Commission has not made a 
final determination on the issue of no significant hazards 
consideration, the Commission will make a final determination on the 
issue of no significant hazards consideration. The final 
determination will serve to establish when the hearing is held. If 
the final determination is that the amendment request involves no 
significant hazards consideration, the Commission may issue the 
amendment and make it immediately effective, notwithstanding the 
request for a hearing. Any hearing would take place after issuance 
of the amendment. If the final determination is that the amendment 
request involves a significant hazards consideration, then any 
hearing held would take place before the issuance of the amendment 
unless the Commission finds an imminent danger to the health or 
safety of the public, in which case it will issue an appropriate 
order or rule under 10 CFR part 2.
    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 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 section of this document discussing electronic submissions (E-
Filing), 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).
    If a hearing is granted, any person who is not a party to the 
proceeding and is not affiliated with or represented by a party may, 
at the discretion of the presiding officer, be

[[Page 75299]]

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 his or her 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. Details regarding the 
opportunity to make a limited appearance will be provided by the 
presiding officer if such sessions are scheduled.

IV.

    All documents filed in NRC adjudicatory proceedings, including a 
request for hearing and petition for leave to intervene (petition), 
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 that request to 
participate under 10 CFR 2.315(c), must be filed in accordance with 
the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 
77 FR 46562; August 3, 2012). 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. Detailed guidance on making electronic submissions may be 
found in the Guidance for Electronic Submissions to the NRC and on 
the NRC website at https://www.nrc.gov/site-help/esubmittals.html. 
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 (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 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 website at https://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has 
obtained a digital ID certificate and a docket has been created, the 
participant can then submit adjudicatory documents. Submissions must 
be in Portable Document Format (PDF). Additional guidance on PDF 
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. 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 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 so that they can 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., 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 
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 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, 11555 
Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and 
Adjudications Staff. Participants filing adjudicatory documents 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 https://adams.nrc.gov/ehd, unless excluded pursuant to an order 
of the Commission or 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. For 
example, in some instances, individuals provide home addresses in 
order to demonstrate proximity to a facility or site. 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 submission.
    The attorney for the CP holder is Nathan Schleifer, General 
Counsel, SHINE Technologies, LLC, 3400 Innovation Court, Janesville, 
WI 53546.

V.

    Accordingly, pursuant to Sections 161b and 161i of the Atomic 
Energy Act of 1954, as amended; 42 U.S.C. Sections 2201(b) and 
2201(i); and 10 CFR 50.90 and 10 CFR 50.55(b), it is hereby ordered 
that CP No. CPMIF-001 is amended to extend the latest date for 
completion of the construction of the SHINE facility from December 
31, 2022, to December 31, 2025, and to change the name of the CP 
holder from SHINE Medical Technologies, LLC to SHINE Technologies, 
LLC.
    This order is effective upon issuance.

    Dated: November 30, 2022.

For the Nuclear Regulatory Commission.

/RA/

Caroline Carusone,

Deputy Director, Division of Advanced Reactors and Non-Power 
Production and Utilization Facilities, Office of Nuclear Reactor 
Regulation.

[FR Doc. 2022-26666 Filed 12-7-22; 8:45 am]
BILLING CODE 7590-01-P