ML22277A818
| ML22277A818 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 12/05/2022 |
| From: | Joshua Borromeo NRC/NRR/DANU/UNPL |
| To: | |
| References | |
| NRC-2022-0180 | |
| Download: ML22277A818 (11) | |
Text
[7590-01-P]
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 S HINE
Medical Technologies, LLC (SHINE) request to amend Construction Permit No. CPMIF-
001 for the SHINE Medical Isotope Production Facility (SHINE fa cility) 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 D ecember 31, 2025, and
administratively change the name of the construction permit hol der from SHINE Medical
Technologies, LLC to SHINE Technologies, LLC.
DATE: 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; em ail:
Stacy.Schumann@nrc.gov. For technical questions, contact the i ndividual listed in the
For Further Information Contact section of this document.
- NRCs Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the ADA MS Public Documents collection at https://www.nrc.gov/reading-rm/adams.ht ml. To begin the
search, select Begin Web-based ADAMS Search. For problems wi th ADAMS, please
contact the NRCs Public Document Room (PDR) reference staff at 1-800-397-4209,
301-415-4737, or by email to PDR.Resource@nrc.gov. The SHINE r equest to amend
Construction Permit No. CPMIF-001 is available in ADAMS under A ccession No.
- NRCs PDR: You may examine and purchase copies of public documents,
by appointment, at the NRCs PDR, Room P1 B35, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852. To make an appointm ent to visit the PDR,
please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-
4737, between 8:00 a.m. and 4:00 p.m. Eastern Time, Monday thr ough 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: Holly.Cruz@nrc.gov.
SUPPLEMENTARY INFORMATION: The text of the Order is attached.
Dated: December 5, 2022.
For the Nuclear Regulatory Commission.
/RA
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.
2 UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
In the Matter of )
)
SHINE Medical Technologies, LLC ) Docket No. 50-608
) Construction Permit No. CPMIF-001 (SHINE Medical Isotope Production Facility) )
ORDER
I.
SHINE Medical Technologies, LLC (SHINE, licensee, permit holder ) is the holder
of Construction Permit (CP) No. CPMIF-001, which the U.S. Nucle ar Regulatory
Commission (NRC, the Commission) issued on February 29, 2016 (A gencywide
Documents Access and Management System (ADAMS) Package Accessio n No.
ML16041A473), for the construction of the SHINE Medical Isotope Production Facility
(SHINE facility) in Rock County, Wisconsin. CP No. CPMIF-001 in cludes December 31,
2022 as the latest date for completion of the construction of t he 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, Ap plication 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 construct ion 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 Technologi es, LLC. SHINE
stated that the proposed name change is administrative because it does not involve any 3
transfer of control of the CP or a change to ownership, organiz ation, rights, or liabilities
of SHINE.
II.
Upon review of the license amendment request, the NRC staff det ermined that
SHINE had shown good cause for extending the latest date for co mpletion of the
construction of the SHINE facility from December 31, 2022, to D ecember 31, 2025 and
that the name change of the CP holder from SHINE Medical Techno logies, LLC to
SHINE Technologies, LLC is administrative in nature. The staff also determined that the
license amendment request involves no significant hazards consi deration. The staff
prepared an environmental assessment and finding of no signific ant impact for the
requested extension of the latest date for completion of constr uction 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 requeste d extension will not
have a significant effect on the quality of the human environme nt. The findings set forth
above are supported by an NRC staff safety evaluation dated Nov ember 30, 2022, which
is available at ML22292A319.
III.
Within 60 days after the date of publication of this notice, an y persons (petitioner)
whose interest may be affected by this action may file a reques t 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 ad ministratively changing
the name of the CP holder and any proceeding hereunder is limit ed to direct challenges
to the CP holders asserted reasons that show good cause for th e extension and to the
name change. Petitions shall be filed in accordance with the Co mmissions Agency
Rules of Practice and Procedure in 10 CFR part 2. Interested p ersons should consult a
4 current copy of 10 CFR 2.309. The NRCs regulations are accessi ble electronically from
the NRC Library on the NRCs website at https://www.nrc.gov/rea ding-
rm/doccollections/cfr/. Alternat ively, a copy of the regulations is available at the NRCs
Public Document Room, located at One White Flint North, Room P1 B35, 11555
Rockville Pike, Rockville, Maryland 20852. If a petition is fil ed, 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 specificall y explain the
reasons why intervention should be permitted with particular re ference to the following
general requirements for standing: (1) the name, address, and t elephone number of the
petitioner; (2) the nature of the petitioners right to be made a party to the proceeding; (3)
the nature and extent of the petitioners property, financial, or other interest in the
proceeding; and (4) the possible effect of any decision or orde r which may be entered in
the proceeding on the petitioners 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 r ely in proving the
contention at the hearing. The petitioner must also provide ref erences to the specific
sources and documents on which the petitioner intends to rely t o 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 la w or fact. Contentions must
be limited to matters within the scope of the proceeding. The c ontention must be one
5 which, if proven, would entitle the petitioner to relief. A pet itioner who fails to satisfy the
requirements at 10 CFR 2.309(f) with respect to at least one co ntention 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 h ave the opportunity to
participate fully in the conduct of the hearing with respect to resolution of that partys
admitted contentions, including the opportunity to present evid ence, consistent with the
NRCs 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 determinati on 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 acc ordance with the filing
instructions in the section of this document discussing electro nic submissions (E-Filing).
If a hearing is requested, and the Commission has not made a fi nal
determination on the issue of no significant hazards considerat ion, the Commission will
make a final determination on the issue of no significant hazar ds 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 cons ideration, the
Commission may issue the amendment and make it immediately effe ctive,
notwithstanding the request for a hearing. Any hearing would ta ke place after issuance
of the amendment. If the final determination is that the amendm ent request involves a
significant hazards consideration, then any hearing held would take place before the
issuance of the amendment unless the Commission finds an immine nt danger to the
health or safety of the public, in which case it will issue an appropriate order or rule
6 under 10 CFR part 2.
A State, local governmental body, Federally recognized Indian T ribe, 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 petitioners interest in
the proceeding. The petition should be submitted to the Commiss ion 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 di scussing electronic
submissions (E-Filing), and shoul d meet the requirements for petitions set forth in this
section, except that under 10 CFR 2.309(h)(2) a State, local go vernmental body, or
Federally recognized Indian Tribe, or agency thereof does not n eed to address the
standing requirements in 10 CFR 2.309(d) if the facility is loc ated 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 2.31 5(c).
If a hearing is granted, any person who is not a party to the p roceeding and is not
affiliated with or represented by a party may, at the discretio n of the presiding officer, be
permitted to make a limited appearance pursuant to the provisio ns of 10 CFR 2.315(a).
A person making a limited appearance may make an oral or writte n 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 impo sed by the presiding
officer. Details regarding the opportunity to make a limited ap pearance 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
7 in the proceeding prior to the submission of a request for hear ing or petition to intervene,
and documents filed by interested governmental entities that re quest to participate under
10 CFR 2.315(c), must be filed in accordance with the NRCs E-F iling rule (72 FR
49139; August 28, 2007, as amended at 77 FR 46562; August 3, 20 12). The E-Filing
process requires participants to submit and serve all adjudicat ory 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 f or Electronic
Submissions to the NRC and on the NRC website at https://www.nr c.gov/site-
help/esubmittals.html. Participants may not submit paper copies of their filings unless
they seek an exemption in accordance with the procedures descri bed below.
To comply with the procedural requirements of E-Filing, at leas t 10 days prior to
the filing deadline, the participant should contact the Office of the Secretary by email at
hearing.docket@nrc.gov, 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 Sec retary that the participant
will be submitting a petition or other adjudicatory document (e ven in instances in which
the participant, or its counsel or representative, already hold s an NRC-issued digital ID
certificate). Based upon this information, the Secretary will e stablish an electronic docket
for the hearing in this proceeding if the Secretary has not alr eady established an
electronic docket.
Information about applying for a digital ID certificate is avai lable on the NRCs
public website at https://www.nrc.gov/site-help/e-submittals/ge tting-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
8 Document Format (PDF). Additional guidance on PDF submissions i s available on the
NRCs public website at https://www.nrc.gov/site-help/electroni c-sub-ref-mat.html. A
filing is considered complete at the time the document is submi tted through the NRCs E-
Filing system. To be timely, an electronic filing must be submi tted to the E-Filing system
no later than 11:59 p.m. Eastern Time on the due date. Upon rec eipt of a transmission,
the E-Filing system time-stamps the document and sends the subm itter an email notice
confirming receipt of the document. The E-Filing system also di stributes an email notice
that provides access to the document to the NRCs Office of the General Counsel and
any others who have advised the Office of the Secretary that th ey wish to participate in
the proceeding, so that the filer need not serve the document o n those participants
separately. Therefore, applicants and other participants (or th eir 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 docum ents via the E-Filing
system.
A person filing electronically u sing the NRCs adjudicatory E-Filing system may
seek assistance by contacting the NRCs Electronic Filing Help Desk through the
Contact Us link located on the NRCs public website at https: //www.nrc.gov/site-
help/e-submittals.html, by email to MSHD.Resource@nrc.gov, or b y 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 su bmitting
documents electronically must file an exemption request, in acc ordance 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 subm it documents in paper
format. Such filings must be subm itted by: (1) first class mail addressed to the Office of
9 the Secretary of the Commission, U.S. Nuclear Regulatory Commis sion, Washington,
DC 20555-0001, Attention: Rulemaking and Adjudications Staff; o r (2) courier, express
mail, or expedited delivery service to the Office of the Secret ary, 11555 Rockville Pike,
Rockville, Maryland 20852, Attention: Rulemaking and Adjudicati ons Staff. Participants
filing adjudicatory documents in this manner are responsible fo r 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 pre siding 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 t hat the reason for granting
the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRCs
electronic hearing docket which is available to the public at h ttps://adams.nrc.gov/ehd,
unless excluded pursuant to an order of the Commission or the p residing officer. If you
do not have an NRC-issued digital ID certificate as described a bove, click cancel when
the link requests certificates and you will be automatically di rected to the NRCs
electronic hearing dockets where you will be able to access any publicly available
documents in a particular hearing docket. Participants are requ ested not to include
personal privacy information, such as social security numbers, home addresses, or
personal phone numbers in their filings, unless an NRC regulati on 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 p urpose of the adjudicatory
filings and would constitute a Fair Use application, participan ts are requested not to
include copyrighted materials in their submission.
10 The attorney for the CP holder is Nathan Schleifer, General Cou nsel, SHINE
Technologies, LLC, 3400 Innovation Court, Janesville, WI 53546.
V.
Accordingly, pursuant to Sections 161b and 161i of the Atomic E nergy Act of
1954, as amended; 42 U.S.C. Sections 2201(b) and 2201(i); and 1 0 CFR 50.90 and 10
CFR 50.55(b), IT IS HEREBY ORDERED that CP No. CPMIF-001 is ame nded 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 C P 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.
11