[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26549-26552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09903]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 50-608; NRC-2021-0090]


SHINE Medical Technologies, LLC; SHINE Medical Isotope Production 
Facility

AGENCY: Nuclear Regulatory Commission.

ACTION: Exemption; issuance.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has issued an 
exemption in response to a June 2, 2020, request from SHINE Medical 
Technologies, LLC from certain NRC regulations related to commercial 
grade dedication of equipment.

DATES: The exemption was issued on April 30, 2021.

ADDRESSES: Please refer to Docket ID NRC-2021-0090 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-2021-0090. Address 
questions about Docket IDs in Regulations.gov to Stacy Schumann;

[[Page 26550]]

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 ADAMS accession number for each 
document referenced (if it is available in ADAMS) is provided the first 
time that it is mentioned in this document.
     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. (EST), 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: The text of the exemption is attached.

    Dated: May 5, 2021.

    For the Nuclear Regulatory Commission.
Steven T. Lynch,
Senior Project Manager, Non-Power Production and Utilization Facility 
Licensing Branch, Division of Advanced Reactors and Non-Power 
Production and Utilization Facilities, Office of Nuclear Reactor 
Regulation.

Attachment--Exemption

Nuclear Regulatory Commission

Docket No. 50-608

SHINE Medical Technologies, LLC

SHINE Medical Isotope Production Facility

I. Background and Request

    SHINE Medical Technologies, LLC (SHINE) is the holder of a 
construction permit issued February 29, 2016 (Agencywide Documents 
Access and Management System (ADAMS) Accession No. ML16041A471), which 
authorizes SHINE to construct the SHINE Medical Isotope Production 
Facility (SHINE facility) in Janesville, Wisconsin, and is currently 
under construction. As authorized by the construction permit, the SHINE 
facility will house an irradiation facility and radioisotope production 
facility. The irradiation facility will consist of eight subcritical 
operating assemblies (or irradiation units), which would each be 
licensed as a utilization facility, as defined in title 10 of the Code 
of Federal Regulations (10 CFR) 50.2, ``Definitions,'' and supporting 
structures, systems, and components (SSCs) for the irradiation of low 
enriched uranium. The radioisotope production facility would consist of 
hot cell structures, licensed collectively as a production facility, as 
defined in 10 CFR 50.2, and associated SSCs for the processing of 
irradiated material and extraction and purification of medical 
radioisotopes. The irradiation facility and radioisotope production 
facility are collectively referred to as the SHINE Medical Isotope 
Production Facility (or SHINE facility). SHINE submitted an application 
for an operating license on July 17, 2019, which the U.S. Nuclear 
Regulatory Commission (NRC) staff accepted for docketing as indicated 
in a Federal Register (FR) notice published on October 15, 2019 (84 FR 
55187). Issuance of the operating license would authorize the applicant 
to operate the SHINE facility for a 30-year period.
    By letter dated June 2, 2020 (ADAMS Accession No. ML20154K754), 
SHINE requested an exemption from certain requirements of 10 CFR 21.3, 
``Definitions,'' related to commercial grade dedication of equipment. 
Specifically, SHINE requested an exemption from the requirements in 10 
CFR 21.3 for the definitions of ``commercial grade item,'' ``basic 
component,'' ``critical characteristic,'' ``dedication,'' and 
``dedicating entity.'' SHINE proposed definitions that SHINE seeks 
permission to use in lieu of the current 10 CFR 21.3 definitions for 
the five terms listed, including the same ``commercial grade item'' 
definition that 10 CFR 21.3 requires for nuclear power plants. Approval 
of this exemption would provide SHINE the flexibility to procure 
facility-specific and other components for the construction of the 
SHINE facility.
    SHINE is planning for the procurement of long lead-time components 
for the SHINE facility and wants to use the commercial grade dedication 
process for certain unique components.
    The definition of ``commercial grade item'' required by 10 CFR 
21.3, for a 10 CFR part 50, ``Domestic Licensing of Production and 
Utilization Facilities,'' facility (other than a nuclear power plant), 
states that a commercial grade item means an item that is: ``(i) [n]ot 
subject to design or specification requirements that are unique to 
those facilities or activities; (ii) [u]sed in applications other than 
those facilities or activities; and (iii) [t]o be ordered from the 
manufacturer/supplier on the basis of specifications set forth in the 
manufacturer's published description.'' In its exemption request, SHINE 
states that this required definition of commercial grade item restricts 
SHINE's ability to use commercial grade dedication of safety-related 
SSCs. SHINE also states that items (i) and (iii) stated above, are 
unnecessarily restrictive for defining commercial grade items. 
Furthermore, items (i) and (iii) stated above complicate and, in many 
cases, prohibit the procurement of certain components to support the 
design and construction of the SHINE Facility.
    SHINE states that its proposed definitions for the five terms 
identified above would allow SHINE to employ an equally controlled and 
safe approach to item procurement. Additionally, SHINE stated that the 
proposed definitions will increase the flexibility to apply a 
commercial grade item procurement strategy for equipment procurements 
(1) to equipment that would not meet the 10 CFR 21.3 definition 
applicable to 10 CFR part 50 licensees that are not nuclear power plant 
licensees; and (2) in situations in which few or no suppliers are 
available with a quality assurance program that meets a quality 
assurance standard endorsed by the NRC and 10 CFR part 21, ``Reporting 
of Defects and Noncompliance,'' procedures.
    SHINE further stated that in 1995, in response to a petition filed 
on behalf of nuclear power plant operators, the NRC determined that the 
definition of ``commercial grade item'' was unnecessarily restrictive 
and resulted in very limited use of the commercial grade item 
designation used by power plant licensees. As a result, the NRC revised 
10 CFR part 21 to provide licensees added flexibility in procuring 
commercial grade items for safety-related services for nuclear power 
plants. See Statement of Considerations (SOC), Federal Register, Volume 
60, page 48369 (September 19, 1995).
    If the exemption were granted, SHINE committed to ``revise the 
commercial grade dedication process to ensure SHINE or its approved 
sub-contractor assumes full responsibility as the dedicating entity in 
cases where SHINE or its approved sub-contractor applies the commercial 
grade item procurement strategy, for compliance with identifying and 
evaluating deviations,

[[Page 26551]]

reporting defects and failure to comply for the dedicated item, and 
maintaining auditable records of the dedication process and performs 
the dedication process.''
    SHINE also committed that, prior to implementing the above 
commercial grade procurement strategy and dedication process, it will 
revise its Quality Assurance Program Description (QAPD) to reflect the 
commitments made in the exemption request dated June 2, 2020.

II. Discussion

    Pursuant to 10 CFR 21.7, ``Exemptions,'' upon application of any 
interested person or on its own initiative, the Commission may grant 
such exemptions from the requirements of 10 CFR part 21 as it 
determines are authorized by law, will not endanger life or property or 
the common defense and security, and are otherwise in the public 
interest. The exemption SHINE seeks would allow SHINE to use different 
definitions for five terms defined in 10 CFR 21.3, thereby providing 
SHINE the flexibility to implement item procurement for facility-
specific and other components in support of the construction of the 
SHINE facility.
    The NRC staff reviewed the information SHINE provided as well as 
similar exemptions granted to Shaw AREVA MOX Services (ADAMS Accession 
No. ML080030393), Louisiana Energy Services, LLC (ADAMS Accession No. 
ML083400454), and AREVA Enrichment Services, LLC (ADAMS Accession No. 
ML110310794). As part of its review, the NRC staff noted that the SOC 
stated that the commercial grade item, when properly and successfully 
dedicated, is deemed by the NRC to be equivalent in its safety function 
performance to the same or a similar item designed and manufactured 
under a 10 CFR part 50, Appendix B, ``Quality Assurance Criteria for 
Nuclear Power Plants and Fuel Reprocessing Plants,'' quality assurance 
program. NRC regulations do not require SHINE, a licensee authorized to 
construct eight non-reactor utilization facilities and one production 
facility, to have a 10 CFR part 50, Appendix B, quality assurance 
program. However, the NRC staff reviewed the SHINE QAPD using American 
National Standards Institute/American Nuclear Society (ANSI/ANS)--15.8-
1995, ``Quality Assurance Program Requirements for Research Reactors,'' 
as endorsed by Regulatory Guide 2.5, Revision 1, ``Quality Assurance 
Program Requirements for Research and Test Reactors'' (ADAMS Accession 
No. ML093520099). The NRC staff found the SHINE QAPD acceptable for the 
design and construction of the proposed SHINE facility in NUREG-2198, 
``Safety Evaluation Report Related to SHINE Medical Technologies, Inc. 
Construction Permit Application for a Medical Radioisotope Production 
Facility'' (ADAMS Accession No. ML16229A140), which supported the 
issuance of the SHINE construction permit. In its exemption request, 
SHINE stated that in all cases the applicable provisions of the ANSI/
ANS-15.8-1995 will be used to conduct the dedication process. If the 
exemption is granted, SHINE committed to revising its QAPD to specify 
the following definitions of commercial grade item, basic component, 
critical characteristics, dedicating entity, and dedication (in lieu of 
the 10 CFR 21.3 definitions):
     Commercial grade item: A commercial grade item means a 
structure, system, or component, or part thereof that affects its 
safety function, that was not designed and manufactured as a basic 
component. Commercial grade items do not include items where the design 
and manufacturing process require in-process inspections and 
verifications to ensure that defects or failures to comply are 
identified and corrected (i.e., one or more critical characteristics of 
the item cannot be verified).
     Basic component: A basic component means a structure, 
system, or component, or part thereof that affects their safety 
function, that is directly procured by the licensee or activity subject 
to the regulations in 10 CFR part 21 and in which a defect or failure 
to comply with any applicable regulation in this chapter, order, or 
license issued by the Commission would create a substantial safety 
hazard. In all cases, basic components include safety-related design, 
analysis, inspection, testing, fabrication, replacement parts, or 
consulting services that are associated with the component hardware 
whether these services are performed by the component supplier or 
others.
     Critical characteristics: Critical characteristics are 
those important design, material, and performance characteristics of a 
commercial grade item that, once verified, will provide reasonable 
assurance that the item will perform its intended safety function.
     Dedication: Dedication is an acceptance process undertaken 
to provide reasonable assurance that a commercial grade item to be used 
as a basic component will perform its intended safety function and, in 
this respect, is deemed equivalent to an item designed and manufactured 
under an ANSI/ANS-15.8-1995 quality assurance program. This assurance 
is achieved by identifying the critical characteristics of the item and 
verifying their acceptability by inspections, tests, or analyses 
performed by the purchaser or third-party dedicating entity after 
delivery, supplemented as necessary by one or more of the following: 
commercial grade surveys; product inspections or witness at holdpoints 
at the manufacturer's facility, and analysis of historical records for 
acceptable performance. In all cases, the dedication process must be 
conducted in accordance with the applicable provisions of ANSI/ANS-
15.8-1995. The process is considered complete when the item is 
designated for use as a basic component.
     Dedicating entity: Dedicating entity means the 
organization that performs the dedication process. Dedication may be 
performed by the manufacturer of the item, a third-party dedicating 
entity, or the licensee itself. The dedicating entity, pursuant to 
Section 21.21(c) of this part, is responsible for identifying and 
evaluating deviations, reporting defects and failure to comply for the 
dedicated item, and maintaining auditable records of the dedication 
process. In cases where the Licensee applies the commercial grade item 
procurement strategy and performs the dedication process, the Licensee 
would assume full responsibility as the dedicating entity.
    The NRC staff determined that the requested exemption is 
permissible under the Atomic Energy Act of 1954, as amended, and that 
no other prohibition of law exists to preclude the activities that 
would be authorized by the exemption. Therefore, the NRC finds that the 
requested exemption is authorized by law.
    The NRC staff determined that the requested exemption will not 
endanger life or property or the common defense and security. In 
adopting the revised definition of ``commercial grade item'' for 
nuclear power plants in 1995, the NRC determined that a commercial 
grade item, when properly and successfully dedicated, is deemed by the 
NRC to be equivalent in its safety function performance to the same or 
similar item designed and manufactured under a 10 CFR part 50, Appendix 
B, quality assurance program. While SHINE does not maintain a 10 CFR 
part 50 Appendix B, quality assurance program, the NRC staff reviewed 
the SHINE QAPD using ANSI/ANS-15.8-1995, as endorsed by Regulatory 
Guide 2.5. The NRC staff found the SHINE QAPD acceptable for the design 
and construction of the proposed SHINE facility with the issuance of 
NUREG-

[[Page 26552]]

2198. Additionally, in the current version of the SHINE QAPD (ADAMS 
Accession No. ML20105A316), SHINE defines safety-related SSCs as 
``those physical SSCs whose intended functions are to prevent accidents 
that could cause undue risk to health and safety of workers and the 
public; and to control or mitigate the consequences of such 
accidents.'' The NRC staff approved of SHINE's use of a custom-
definition of safety-related SSCs in NUREG-2198 because the 10 CFR 50.2 
definition of ``safety-related structures, systems, and components'' 
did not apply to a facility that was not a power reactor and the custom 
definition was appropriate for the SHINE facility. The NRC staff 
similarly concludes that the definitions that SHINE proposes to use (in 
lieu of the those required by 10 CFR 21.3) are similar to those 
previously approved at other facilities and are appropriate for the 
SHINE facility, which has SSCs with unique design or specification 
requirements based on their intended safety function. Accordingly, the 
revision of the QAPD to incorporate the proposed definitions and the 
assumption by SHINE (or its approved sub-contractor) of full 
responsibility as the dedicating entity are appropriate to support 
procurement of certain unique items because they will provide a 
controlled and safe approach for item procurement for the construction 
of the first-of-its-kind SHINE facility. Therefore, the NRC finds that 
the requested exemption does not endanger life or property or the 
common defense and security.
    The NRC staff determined that the requested exemption is in the 
public interest. The requested exemption would allow SHINE to implement 
a controlled and safe approach to item procurement for the construction 
of the SHINE facility. Additionally, consistent with the American 
Medical Isotopes Production Act of 2012 (42 U.S.C. 2065), construction 
of the SHINE facility supports the establishment of a domestically-
produced commercial supply of molybdenum-99, which is in the interest 
of public health. Therefore, the NRC finds that the requested exemption 
is in the public interest.

III. Environmental Considerations

    The granting of this exemption is categorically excluded under 10 
CFR 51.22, ``Criterion for categorical exclusion; identification of 
licensing and regulatory actions eligible for categorical exclusion or 
otherwise not requiring environmental review,'' paragraph (c)(25), and 
there are no special circumstances present that would preclude reliance 
on this exclusion. The NRC staff determined, per 10 CFR 
51.22(c)(25)(vi)(I), that the requirements from which the exemption is 
sought involve other requirements of an administrative, managerial, or 
organizational nature. The NRC staff also determined that approval of 
this exemption involves no significant hazards consideration because 
authorizing the use of the specified definitions that differ from those 
in 10 CFR 21.3 does not authorize any physical changes to the facility 
or any of its safety systems, does not change any of the assumptions or 
limits used in SHINE's safety analyses, does not introduce any new 
failure modes, and allows procurement of commercial grade items, which 
if properly dedicated, will have comparable safety functions. As a 
result, there is no significant increase in the probability or 
consequences of an accident previously evaluated, there is no creation 
of the possibility of a new or different kind of accident from any 
accident previously evaluated, and there is no significant reduction in 
a margin of safety.
    In addition, because the SHINE facility is under construction and 
an operating license has not been issued, there is no significant 
change in the types or significant increase in the amounts of any 
effluents that may be released offsite because the exemption does not 
affect any effluent release limits as provided in SHINE's technical 
specifications or by the regulations in 10 CFR part 20, ``Standards for 
Protection Against Radiation.'' There is no significant increase in 
individual or cumulative public or occupational radiation exposure 
because the exemption does not affect the limits on the release of any 
radioactive material or the limits provided in 10 CFR part 20 for 
radiation exposure to workers or members of the public. There is no 
significant construction impact because the exemption does not involve 
any changes to a construction permit. There is no significant increase 
in the potential for or consequences from radiological accidents 
because the exemption does not alter any of the assumptions or limits 
in SHINE's safety analysis. Therefore, the NRC has determined that 
granting the exemption would not individually or cumulatively have a 
significant effect on the human environment.

IV. Conclusions

    Based on its review, the NRC staff finds that the use of the SHINE-
proposed definitions of commercial grade item, basic component, 
critical characteristics, dedication, and dedicating entity do not 
adversely affect public health and safety. Therefore, the use of 
commercial grade items by SHINE, which are properly dedicated, is 
acceptable. Further, the NRC staff considered the requirements of 10 
CFR 21.7 and finds that granting this exemption from certain 10 CFR 
21.3 definitions is authorized by law and will not endanger life or 
property or the common defense and security, and is otherwise in the 
public's interest. Therefore, the NRC grants the exemption from 10 CFR 
21.3 definitions of commercial grade item, basic component, critical 
characteristics, dedicating entity, and dedication, subject to the 
condition that (1) SHINE revise its QAPD consistent with the alternate 
definitions stated above and prior to assuming full responsibility as 
the dedicating entity or otherwise implementing its commercial grade 
procurement strategy and dedication process, and (2) SHINE shall submit 
the revised QAPD to the NRC consistent with the 10 CFR 50.34(b)(6)(ii) 
requirement to include managerial and administrative controls to be 
used to assure safe operation of the facility as part of the final 
safety analysis report for an operating license application.
    This exemption is effective upon issuance.

    Dated at Rockville, Maryland, this 30th day of April 2021.

    For the Nuclear Regulatory Commission.

/RA/

Brian W. Smith,

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

[FR Doc. 2021-09903 Filed 5-13-21; 8:45 am]
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