[Federal Register Volume 79, Number 201 (Friday, October 17, 2014)]
[Rules and Regulations]
[Pages 62329-62335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24732]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 50

[NRC-2013-0053]
RIN 3150-AJ18


Definition of a Utilization Facility

AGENCY: Nuclear Regulatory Commission.

ACTION: Direct final rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its 
regulations to add SHINE Medical Technologies, Inc.'s (SHINE) proposed 
accelerator-driven subcritical operating assemblies to the NRC's 
definition of a ``utilization facility.'' In 2013, SHINE submitted a 
two-part construction permit application for a medical radioisotope 
production facility that SHINE proposes to build in Janesville, 
Wisconsin. The proposed accelerator-driven subcritical operating 
assemblies, to be housed in SHINE's irradiation facility, would be used 
to produce molybdenum-99 (Mo-99), a radioisotope used in medical 
imaging and other radioisotopes used for medical purposes. This rule 
allows NRC staff to conduct an efficient and effective licensing review 
of the SHINE construction permit application and any subsequent 
operating license application.

DATES: This final rule is effective December 31, 2014, unless a 
significant adverse comment is received by November 17, 2014. If the 
rule is withdrawn as a result of such comments, timely notice of the 
withdrawal will be published in the Federal Register. Comments received 
after this date will be considered if it is practical to do so, but the 
NRC is able

[[Page 62330]]

to ensure consideration only for comments received on or before this 
date.

ADDRESSES: Please refer to Docket ID NRC-2013-0053 when contacting the 
NRC about the availability of information for this direct final rule. 
You may access publicly-available information related to this direct 
final rule by any of the following methods:
    <bullet> Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0053. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: <a href="/cdn-cgi/l/email-protection#de9dbfacb1b2f099bfb2b2bfb9b6bbac9eb0acbdf0b9b1a8"><span class="__cf_email__" data-cfemail="6c2f0d1e0300422b0d00000d0b04091e2c021e0f420b031a">[email protected]</span></a>. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
    <bullet> 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, at 301-415-4737, or by email to <a href="/cdn-cgi/l/email-protection#0f7f6b7d217d6a7c607a7d6c6a4f617d6c21686079"><span class="__cf_email__" data-cfemail="b4c4d0c69ac6d1c7dbc1c6d7d1f4dac6d79ad3dbc2">[email protected]</span></a>. 
The ADAMS accession number for each document referenced (if it is 
available in ADAMS) is provided the first time that it is mentioned in 
the SUPPLEMENTARY INFORMATION section.
    <bullet> 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; telephone: 301-415-1524; email: 
<a href="/cdn-cgi/l/email-protection#1f4c6b7a697a71315366717c775f716d7c31787069"><span class="__cf_email__" data-cfemail="88dbfcedfeede6a6c4f1e6ebe0c8e6faeba6efe7fe">[email protected]</span></a>; U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Procedural Background
II. Background
III. Discussion
    A. What action is the NRC taking?
    B. What is the purpose of the direct final rule?
    C. What is the NRC's authority to make this rule change?
    D. Why are the SHINE irradiation units not considered production 
facilities?
    E. Why do the SHINE irradiation units not fit the current 
definition of a utilization facility?
    F. Why should the SHINE irradiation units be licensed as 10 CFR 
part 50 utilization facilities?
    G. Who has jurisdiction over the accelerator?
    H. Why is 10 CFR part 70 not appropriate to review or license 
the SHINE irradiation units?
    I. Who will this action affect?
    J. What is the reason for the change?
    K. Why is a direct final rule appropriate?
    L. Will the NRC issue guidance for this rule?
IV. Discussion of Amendments by Section
V. Regulatory Flexibility Certification
VI. Regulatory Analysis
VII. Backfitting and Issue Finality
VIII. Plain Writing
IX. Environmental Assessment and Finding of No Significant 
Environmental Impact
X. Paperwork Reduction Act Statement
XI. Congressional Review Act
XII. Compatibility of Agreement State Regulations
XIII. Voluntary Consensus Standards

I. Procedural Background

    Because the NRC considers this action to be non-controversial, the 
NRC is using the ``direct final rule process'' for this rule. The 
amendment to the rule will become effective on December 31, 2014. 
However, if the NRC receives a significant adverse comment on this 
direct final rule by November 17, 2014, then the NRC will publish a 
document that withdraws this action and will subsequently address the 
comments received in a final rule. A companion proposed rule published 
in the Proposed Rule section of this issue of the Federal Register will 
serve as the basis for the final rule, if it is necessary. Absent 
significant modifications to the proposed amendments requiring 
republication, the NRC will not initiate a second comment period on 
this action.
    A significant adverse comment is a comment where the commenter 
explains why the rule would be inappropriate, including challenges to 
the rule's underlying premise or approach, or would be ineffective or 
unacceptable without a change. A comment is significant and adverse if 
it meets the following criteria:
    (1) The comment opposes the rule and provides a reason sufficient 
to require a substantive response in a notice-and-comment process. For 
example, a substantive response is required when:
    (a) The comment causes the NRC staff to reevaluate (or reconsider) 
its position or conduct additional analysis;
    (b) The comment raises an issue serious enough to warrant a 
substantive response to clarify or complete the record; or
    (c) The comment raises a relevant issue that was not previously 
addressed or considered by the NRC staff.
    (2) The comment proposes a change or an addition to the rule, and 
it is apparent that the rule would be ineffective or unacceptable 
without incorporation of the change or addition.
    (3) The comment causes the NRC staff to make a change (other than 
editorial) to the rule.
    For detailed instructions on submitting comments, please see the 
companion proposed rule published in the Proposed Rule section of this 
issue of the Federal Register.

II. Background

    By letters dated February 14, 2011, and May 3, 2011,\1\ SHINE 
notified the NRC of its intent to submit applications to construct, and 
operate, a medical isotope production facility. SHINE's medical isotope 
production facility would include an irradiation facility and a 
radioisotope production facility housed in a single building, and is 
proposed to be built in Wisconsin, an Agreement State.
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    \1\ Letter from Gregory Piefer, Ph.D., SHINE, to Mr. John 
Kinnemann, Office of Nuclear Material Safety and Safeguards (NMSS), 
``Notice of Intent to Submit License Application, Request for 
Regulatory Interpretations, and Request for Public Meetings,'' dated 
February 14, 2011 (ADAMS Accession No. ML110490138); and Letter from 
Gregory Piefer, Ph.D., SHINE, to Mr. John Kinnemann, NMSS, ``Updated 
Request for Regulatory Interpretations,'' dated May 3, 2011 (ADAMS 
Accession No. ML11138A220), respectively.
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    The SHINE preliminary safety analysis report (PSAR) \2\ states that 
the irradiation facility consists of eight irradiation units. Each 
irradiation unit is an accelerator-driven subcritical operating 
assembly and, would be used for the irradiation of a uranium 
solution.\3\ The irradiation would result in the production of Mo-99 
and other fission products. Based on initial discussions with SHINE 
prior to the submission of its application, the NRC staff understood 
that the proposed irradiation units were not nuclear reactors as 
defined in Sec.  50.2 of Title 10 of the Code of Federal Regulations 
(10 CFR). The NRC staff believed that the irradiation units, including 
the accelerators, were an integral part of the radioisotope production 
facility. Therefore, the NRC staff believed that the SHINE irradiation 
units and radioisotope production facility could be jointly licensed 
under the third part of the production facility definition found in 10 
CFR 50.2. Based on these assumptions, the NRC staff relayed to

[[Page 62331]]

the Commission on May 11, 2012, that no rulemaking was required to 
license SHINE's proposed medical isotope production facility.\4\
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    \2\ PSAR, Chapter 4--Irradiation Unit and Radioisotope 
Production Facility Description (May 31, 2013) (ADAMS Accession No. 
ML13172A265).
    \3\ SHINE's preliminary safety analysis report describes each 
irradiation unit containing uranium solution as ``. . . an 
accelerator-driven subcritical operating assembly used for the 
irradiation of an aqueous uranyl sulfate target solution, resulting 
in the production of molybdenum-99 (Mo-99) and other fission 
products.'' (ADAMS Accession No. ML13172A265).
    \4\ Transcript of NRC Briefing on Potential Medical Isotope 
Production Licensing Actions, pages 55-56, 61-62 (May 11, 2012) 
(ADAMS Accession No. ML121370084).
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    In 2012, the NRC staff published interim staff guidance (ISG) \5\ 
to augment NUREG-1537, ``Guidelines for Preparing and Reviewing 
Applications for the Licensing of Non-Power Reactors.'' The ISG noted 
that a subcritical multiplier reaction vessel containing special 
nuclear material (SNM), similar to the irradiation units proposed by 
SHINE, could be licensed as a production facility pursuant to 10 CFR 
part 50.\6\ Based on the guidance provided in the ISG, on March 26, 
2013, and May 31, 2013, SHINE submitted a two-part construction permit 
application for a production facility as defined in 10 CFR 50.2.\7\ 
SHINE's application describes its proposed medical isotope production 
facility as including two distinct operations: (1) The irradiation of 
SNM in eight irradiation units in the irradiation facility and (2) the 
extraction of radioisotopes in the radioisotope production facility. 
From this description, the NRC staff recognized that the irradiation 
units could be distinct and separate from the radioisotope production 
facility. Therefore, the NRC staff no longer believes that the 
irradiation units can be licensed pursuant to 10 CFR 50.2 as production 
facilities since the irradiation units are neither integral to the 
operation of the radioisotope production facility nor functionally 
independent as production facilities.
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    \5\ NUREG-1537, ``Final Interim Staff Guidance Augmenting NUREG-
1537, Part 1, `Guidelines for Preparing and Reviewing Applications 
for the Licensing of Non-Power Reactors: Format and Content,' for 
Licensing Radioisotope Production Facilities and Aqueous Homogeneous 
Reactors,'' October 17, 2012 (ADAMS Accession No. ML12156A069).
    \6\ The ISG noted that a ``subcritical multiplier reaction 
vessel containing SNM by definition is not a nuclear reactor because 
it cannot sustain a chain reaction. It may be included in a 10 CFR 
part 50 production facility license as an assembly containing SNM 
that is authorized for use in conjunction with the production 
facility.'' ISG page iv.
    \7\ See Letter from R. Vann Bynum, Ph.D., SHINE, to NRC dated 
March 26, 2013 (ADAMS Accession No. ML13088A192). This transmittal 
letter is in a document package (ADAMS Accession No. ML130880226), 
which includes part one of SHINE's application, consisting of 
portions of the PSAR, specifically Chapter 2, Site Characteristics 
and Chapter 19, Environmental Report (ER).
    See also Letter from R. Vann Bynum, Ph.D., SHINE, to NRC dated 
May 31, 2013 (ADAMS Accession No. ML13172A361). A document package 
consisting of a public version of all 19 chapters of SHINE's PSAR 
(with proprietary information redacted) is also available in ADAMS, 
Accession No. ML13172A324.
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    Moreover, the irradiation units cannot be licensed as utilization 
facilities because they do not meet the current definition in 10 CFR 
50.2. As currently defined in 10 CFR 50.2, a utilization facility is a 
nuclear reactor, and irradiation units are not nuclear reactors because 
they are not designed or used to sustain nuclear fission in a self-
supporting chain reaction. Therefore, the current 10 CFR part 50 
regulations governing licensing of production and utilization 
facilities do not apply to SHINE's irradiation facility or irradiation 
units.\8\
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    \8\ See 10 CFR 50.1, ``Basis, purpose, and procedures 
applicable'' (defining scope of 10 CFR part 50 to include only the 
licensing of production and utilization facilities).
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    However, the NRC staff maintains its initial position that SHINE's 
radioisotope production facility is analogous to a ``production 
facility'' and therefore should be licensed under 10 CFR part 50. 
Specifically, the radioisotope production facility is a facility 
designed or used for the processing of irradiated materials containing 
SNM and does not meet any of the exceptions found in the definition of 
production facility in 10 CFR 50.2.

III. Discussion

A. What action is the NRC taking?

    The NRC is amending its regulations to add SHINE's accelerator-
driven subcritical operating assemblies described in the application 
assigned docket number 50-608 to the definition of utilization facility 
in 10 CFR 50.2.

B. What is the purpose of the direct final rule?

    The purpose of the direct final rule is to add SHINE's accelerator-
driven subcritical operating assemblies to the definition of 
utilization facility in 10 CFR 50.2. This change will allow the NRC 
staff to review and, if approved, license the irradiation units housed 
in SHINE's irradiation facility under the regulations in 10 CFR part 
50.

C. What is the NRC's authority to make this rule change?

    Section 11cc. of the Atomic Energy Act of 1954, as amended (AEA), 
specifies that the Commission may determine by rule what constitutes a 
utilization facility. The licensing requirements for utilization 
facilities are in 10 CFR part 50. This rulemaking will resolve any 
licensing uncertainty concerning the applicable regulations for 
licensing the construction and potential operation of the SHINE 
irradiation units, as well as expedite the NRC staff's technical review 
of the SHINE construction permit application.

D. Why are the SHINE irradiation units not considered production 
facilities?

    The NRC has determined that SHINE's irradiation units are not 
integral to the operation of the radioisotope production facility. In 
addition, the irradiation units do not meet any of the existing 
definitions of production facility in the AEA or in 10 CFR 50.2; 
therefore, they cannot be licensed as production facilities.
    Pursuant to Section 11v. of the AEA, the Commission has determined 
by rule in 10 CFR 50.2 that three types of facilities constitute 
production facilities. First, ``production facility'' is defined as any 
nuclear reactor designed or used primarily for the formation of 
plutonium or uranium-233. The proposed irradiation units do not meet 
this definition because they are not nuclear reactors designed or used 
primarily for the formation of plutonium or uranium-233. Rather, the 
irradiation units are designed and used primarily to fission uranium 
for the production of fission products. Additionally, in contrast to 
nuclear reactors, the proposed irradiation units are designed to 
operate in the subcritical regime, and are not designed or used to 
sustain a self-supporting chain reaction.
    Second, ``production facility'' is defined as any facility designed 
or used for the separation of the isotopes of plutonium. SHINE's 
proposed irradiation units do not meet this definition because they are 
designed to irradiate a uranium solution, not separate the isotopes of 
plutonium.
    Third, ``production facility'' is defined as any facility designed 
or used for the processing of irradiated materials containing SNM. 
While ``processing,'' as used in the definition of production facility, 
is not defined in the regulations, the NRC staff does not consider 
processing to include the irradiation and fission of materials, whether 
the material was irradiated previously or not, containing SNM. Given 
the similarities between the treatment of SHINE's target solution and 
the fuel in existing power and non-power reactors, the NRC staff does 
not consider the irradiation units' function to constitute the 
processing of irradiated materials. For example, all fuel in existing 
utilization facilities, including both power and non-power reactors, 
undergoes irradiation and fission, beginning with its first use to 
start-up a reactor. Furthermore, it is common practice in existing 
utilization facilities to offload irradiated fuel from the

[[Page 62332]]

reactor core for refueling outages and maintenance. When it is time to 
refuel the reactor following an outage or maintenance, much of the 
irradiated fuel is returned to the reactor core for continued 
irradiation and fission. This treatment of reactor fuel is analogous to 
SHINE's treatment of its target solution. Following irradiation, SHINE 
offloads the target solution from the irradiation units. The target 
solution is then transferred to SHINE's radioisotope production 
facility for a period of time before it is returned to the irradiation 
units for continued irradiation and fission.
    Since all existing power and non-power reactors are regulated as 
utilization facilities, it is clear that continuing to irradiate and 
fission previously irradiated reactor fuel does not constitute the 
processing of irradiated materials containing SNM, otherwise all 
existing reactors would be classified as production facilities per 10 
CFR 50.2. Consequently, based on the NRC staff's assessment, SHINE's 
proposed irradiation units cannot be considered production facilities.

E. Why do the SHINE irradiation units not fit the current definition of 
a utilization facility?

    SHINE's proposed irradiation units do not meet the current 
definition of a utilization facility because the units do not, singly 
or collectively sustain nuclear fission in a self-supporting chain 
reaction. As a result, the NRC staff concluded that the current 
regulatory definition of utilization facility does not apply to the 
irradiation units, and they cannot currently be licensed as utilization 
facilities as defined in 10 CFR 50.2.

F. Why should the SHINE irradiation units be licensed as 10 CFR part 50 
utilization facilities?

    The premise of the SHINE technology is that the irradiation units 
will not be operated such that the effective neutron multiplication 
factor (k<INF>eff</INF>) is greater than or equal to 1.0, a range for 
which nuclear reactors are designed, analyzed, and licensed to operate 
safely. Instead, the irradiation units will only operate in a minimally 
subcritical range of k<INF>eff</INF>. To operate safely within this 
margin of subcriticality, the irradiation units are designed with 
several features of a nuclear reactor except that, by design, the 
target solution vessels have insufficient reactivity to sustain a chain 
reaction.
    In addition, the accelerator and neutron multiplier add sufficient 
external neutrons to the target solution vessel to achieve a fission 
rate with a thermal power level comparable to non-power reactors 
typically licensed under 10 CFR part 50 as utilization facilities.\9\ 
Given this fission power, the irradiation units also have many safety 
considerations similar to those of non-power reactors, including the 
following:
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    \9\ Non-power reactors currently licensed to operate by the NRC 
range in thermal power from 5 watts to 20 megawatts. In the past, 
the NRC has licensed 12 aqueous homogeneous reactors (AHRs) with 
thermal power levels ranging from 5 watts to 50 kilowatts. An AHR is 
similar to the SHINE target solution vessel in that both contain 
fissile material in an aqueous solution; the difference is that the 
target solution vessel has insufficient fissile material to support 
a sustained chain reaction.
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    <bullet> Provisions for removal of fission heat during operation.
    <bullet> Consideration of decay heat generation after shutdown.
    <bullet> Reactivity feedback mechanisms similar to non-power 
reactors.
    <bullet> Control of fission gas release during operation and 
subsequent gas management engineering safety features.
    <bullet> Control of radiolytic decomposition of water and generated 
oxygen and hydrogen gases.
    <bullet> Control of fission product inventory buildup.
    <bullet> Accident scenarios similar to non-power reactors, such as 
loss of coolant, reactivity additions, and release of fission products.
    Although SHINE's proposed irradiation units closely resemble non-
power reactors, which are licensed as utilization facilities under 10 
CFR part 50, the irradiation units cannot currently be licensed as 
utilization facilities because they are not nuclear reactors. 
Therefore, while 10 CFR part 50 would be appropriate to apply from a 
technical and licensing review process standpoint, the irradiation 
units cannot be licensed as utilization facilities under the current 
regulations.
    The NRC staff believes, however, that based on the safety 
considerations associated with operation of the irradiation units, the 
NRC should define and license each of the irradiation units as a 
utilization facility. Section 11cc. of the AEA provides that the 
Commission may determine what a utilization facility is by rule.\10\ 
Section 11cc. of the AEA provides that a utilization facility is any 
equipment or device determined by rule of the Commission to be capable 
of making use of special nuclear material in a quantity that is of 
significance to the common defense and security or in a manner that 
affects the health and safety of the public. Therefore, it would be 
within the Commission's authority to designate the SHINE irradiation 
units, by rule, as utilization facilities.
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    \10\ Likewise, the Commission may by rule define what 
constitutes a production facility, AEA Section 11v. The Commission 
has previously used the rulemaking process to amend its definition 
of production facility. See Licensing of Production and Utilization 
Facilities (21 FR 355; January 19, 1956), Definition of Production 
Facility (26 FR 4989, 4990; June 6, 1961), and Exemption for 
Facilities Processing Irradiated Materials Containing Limited 
Quantities of Special Nuclear Material (39 FR 4871; February 8, 
1974).
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G. Who has jurisdiction over the accelerator?

    Because the accelerator is integral to the operation of the 
irradiation unit, and the Commission must retain authority and 
responsibility with respect to regulation of the entire utilization 
facility per Section 274c.(1) of the AEA, the Commission has 
jurisdiction over the accelerator.
    The NRC staff has engaged with the state of Wisconsin regarding 
licensing of the SHINE irradiation units because an accelerator that is 
not part of an NRC licensed facility might be regulated under state 
law. Based on the NRC staff's informal discussions with Agreement State 
counterparts, the NRC staff does not expect the state of Wisconsin to 
object to the rule or licensing review process for the SHINE 
construction permit application.

H. Why is 10 CFR part 70 not appropriate to review or license the SHINE 
irradiation units?

    The NRC staff considered whether it should review SHINE's 
irradiation units under 10 CFR part 70, ``Domestic Licensing of Special 
Nuclear Material,'' which regulates the issuance of licenses to receive 
title to, own, acquire, deliver, receive, possess, use, and transfer 
SNM. From a regulatory perspective, 10 CFR part 70 could be applied 
because SHINE will acquire, receive, possess, use, and transfer SNM. 
The requirements of 10 CFR part 70, subpart H, ``Additional 
Requirements for Certain Licensees Authorized To Possess a Critical 
Mass of Special Nuclear Material,'' could also be applied because SHINE 
will possess a critical mass of SNM, and will engage in an activity 
that could significantly affect public health and safety.
    The facilities conducting the types of activities typically 
regulated under 10 CFR part 70, generally referred to as fuel cycle 
facilities, have a common objective of avoiding criticality by 
maintaining a significant margin from criticality under normal 
operating and accident conditions. Specifically, 10 CFR 70.61(d) calls 
for ``. . . use of an approved margin of subcriticality for safety.'' 
SHINE's irradiation units have a proposed routine operating margin of 
subcriticality of less than what has been previously approved for other 
10 CFR part 70 licensees. This operating state

[[Page 62333]]

more closely resembles the effective neutron multiplication factor of 
nuclear reactors than fuel cycle facilities.\11\ SHINE states that its 
proposed margin of subcriticality is needed to carry out efficient 
production of Mo-99, and proposes to control reactivity through 
administrative and engineered controls, including careful control of 
the amount of SNM initially placed in the target solution vessels. 
Also, in order to operate safely at SHINE's proposed margin of 
subcriticality, the irradiation units are designed with inherent 
negative reactivity feedback mechanisms similar to those of nuclear 
reactors. Because SHINE proposes to operate each irradiation unit in a 
manner similar to a nuclear reactor, the NRC staff has determined that 
it would be most appropriate to use the regulations contained in 10 CFR 
part 50 to perform its technical review of the irradiation units.
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    \11\ PSAR, Chapter 4--Irradiation Unit and Radioisotope 
Production Facility Description (May 31, 2013) (ADAMS Accession No. 
ML13172A265).
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I. Who will this action affect?

    The direct final rule will apply only to the irradiation units 
proposed by SHINE under docket number 50-608. This rulemaking will 
affect SHINE by bringing the licensing of its proposed facility, 
including both its irradiation facility and radioisotope production 
facility, entirely within the regulations of 10 CFR part 50. As a 
result of this rulemaking, the NRC will have exclusive jurisdiction 
over the SHINE facility, including the licensing and oversight of the 
accelerators associated with the irradiation units. Since Agreement 
States typically regulate accelerators, the direct final rule will also 
affect the state of Wisconsin. The rulemaking will not impact the 
public's opportunity to comment or participate in a hearing on the 
pending SHINE construction permit application or, if submitted, any 
future operating license application.

J. What is the reason for the change?

    The rulemaking will allow the NRC staff to conduct its licensing 
review of the proposed SHINE irradiation units following regulations 
designed for technologies with similar radiological, health, and safety 
considerations. While the proposed irradiation units do not currently 
fit the 10 CFR part 50 definitions of production or utilization 
facilities, it is within the NRC's authority under the AEA to determine 
by rule that the SHINE irradiation units are utilization facilities. 
The Commission has found that 10 CFR part 50 is the most appropriate 
regulation to apply to the licensing of the SHINE irradiation units.

K. Why is a direct final rule appropriate?

    The NRC believes that a direct final rule is appropriate for the 
following reasons:
    1. From a health and safety standpoint the requirements in 10 CFR 
part 50 are the most appropriate for the licensing and technical review 
of the proposed irradiation units.
    2. Designating each proposed irradiation unit, by rule, as a 
utilization facility is within the Commission's authority under the 
AEA.
    3. The proposed irradiation units share many characteristics of 
non-power reactors, which are licensed as utilization facilities under 
10 CFR part 50.
    4. SHINE has submitted a construction permit application that 
contains the majority of regulatory information required of utilization 
facilities.
    5. The proposed rulemaking only affects the irradiation units 
proposed by SHINE under docket number 50-608.
    The NRC staff is using a direct final rule because it considers 
this rulemaking to be non-controversial, it does not expect to receive 
significant adverse comments, and using the direct final rule process 
would allow the rulemaking to proceed in the most efficient manner. The 
direct final rule is expected to be non-controversial because the NRC 
has the authority under the AEA to define what constitutes a 
utilization facility; interested parties, including SHINE, have not 
objected to discussions and published guidance proposing licensing 
under 10 CFR part 50. Additionally, the rule does not affect the 
ability of the public to comment and request a hearing on the 
application; and the inclusion of SHINE's docket number as well as a 
description of the SHINE irradiation unit technology limits the 
applicability of the rule to SHINE's proposed irradiation units, 
ensuring no impact to other existing or future facilities. If, in the 
future, any applicant proposes a technology similar to SHINE's 
irradiation units,\12\ the Commission would consider that application 
on a case-by-case basis, and assign a distinct docket number to each 
application. Should SHINE propose a technology other than the 
irradiation units currently described in its PSAR, the rule would no 
longer apply to SHINE, and the NRC staff would pursue an alternative 
licensing approach.
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    \12\ At this time, the NRC staff does not anticipate receiving 
any other applications for medical radioisotope production 
facilities that would propose a technology similar to SHINE's 
irradiation units.
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    As previously explained, because the irradiation units are similar 
to non-power reactors, the NRC staff finds the 10 CFR part 50 
regulations most appropriate to apply in the review of this proposed 
technology. To limit the scope of this rulemaking, the NRC staff is 
recommending that this rule be made applicable to only the SHINE 
facility. A generic rulemaking has potential for unintended 
consequences on the regulation of other licensees. Expansion of the 
definition of utilization facility generically could result in 
inclusion of technologies appropriately regulated by Agreement States 
or under 10 CFR part 70 within the regulatory scope of 10 CFR part 50, 
which would reduce the NRC's regulatory efficiency.
    By identifying 10 CFR part 50 as the licensing framework to review 
and evaluate the irradiation units in the SHINE construction permit 
application, this rulemaking would clarify the appropriate regulatory 
requirements governing SHINE's requested licensing action for the 
applicant; interested members of the public; federal, state, Tribal, 
and local government representatives; and other interested 
stakeholders. Additionally, in alignment with the objectives of the 
American Medical Isotopes Production Act of 2012, this rulemaking will 
provide the most efficient and effective pathway to reviewing and, if 
approved, licensing SHINE's proposed irradiation units and will support 
the national effort to establish a reliable domestic supply of Mo-99 
utilizing low enriched uranium technologies.

L. Will the NRC issue guidance for this rule?

    No, the NRC does not plan to issue guidance specific to this rule. 
The guidance provided in NUREG-1537 (ADAMS Accession No. ML12251A353), 
NUREG-1520 (ADAMS Accession No. ML101390110), and the Final Interim 
Staff Guidance Augmenting NUREG-1537 (ADAMS Accession No. ML12156A069) 
is sufficient to support the review of SHINE's construction permit 
application under the regulations in 10 CFR part 50. However, the NRC 
staff is preparing a revision to NUREG-1537, which will incorporate the 
content of the ISG, including any necessary corrections.

[[Page 62334]]

IV. Discussion of Amendments by Section

Section 50.2 Definitions

    The definition for utilization facility will be changed to add: An 
accelerator-driven subcritical operating assembly used for the 
irradiation of materials containing special nuclear material and 
described in the application assigned docket number 50-608.

Authority Citation

    The authority citation for 10 CFR part 50 is being revised to 
include Section 11 of the AEA because Subsection 11cc. provides the 
Commission's authority to add to, or otherwise alter, the definition of 
utilization facility. In addition, minor editorial changes were made to 
the authority citation.

V. Regulatory Flexibility Certification

    Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the 
Commission certifies that this rule does not have a significant 
economic impact on a substantial number of small entities. The direct 
final rule will impact one applicant for a construction permit, who may 
subsequently apply for an operating license. Although this company 
falls within the scope of the definition of ``small entities'' set 
forth in the Regulatory Flexibility Act or the size standards 
established by the NRC (10 CFR 2.810), the rule is intended to 
facilitate NRC staff review of the company's construction permit 
application and subsequent operating license application.

VI. Regulatory Analysis

    The NRC has prepared a final regulatory analysis (ADAMS Accession 
No. ML14052A115) on this regulation. The analysis examines the costs 
and benefits of the alternatives considered by the NRC.

VII. Backfitting and Issue Finality

    The NRC has determined that the backfit rule, 10 CFR 50.109, and 
the issue finality provisions in 10 CFR part 52, and the backfitting 
provisions in 10 CFR 70.76, 72.62, or 76.76 do not apply to this direct 
final rule because the only affected entity, SHINE, is currently an 
applicant for a construction permit. These backfitting and issue 
finality provisions, with exceptions not applicable here, do not apply 
to applicants. For these reasons, the NRC did not prepare either a 
backfit analysis or documentation addressing issue finality provisions 
in 10 CFR part 52 for this direct final rule.

VIII. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal 
agencies to write documents in a clear, concise, and well-organized 
manner. The NRC has written this document to be consistent with the 
Plain Writing Act as well as the Presidential Memorandum, ``Plain 
Language in Government Writing,'' published June 10, 1998 (63 FR 
31883).

IX. Environmental Assessment and Finding of No Significant 
Environmental Impact

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
subpart A of 10 CFR part 51, that this rule would not be a major 
Federal action significantly affecting the quality of the human 
environment, and therefore, an environmental impact statement is not 
required. The rule changes the definition of utilization facility to 
include the SHINE irradiation units for the purposes of facilitating 
the licensing review of one proposed facility. The rule will not affect 
radiological or non-radiological releases, nor will it affect 
occupational or public exposure. The determination of this 
environmental assessment is that there will be no significant offsite 
impact to the public from this action.
    The NRC has prepared a final Environmental Assessment and Finding 
of No Significant Impact (ADAMS Accession No. ML14052A097).

X. Paperwork Reduction Act Statement

    This direct final rule affects only one entity and therefore is not 
subject to the requirements of the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.).

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
Office of Management and Budget control number.

XI. Congressional Review Act

    This is a rule of particular applicability and, as such, this 
action is not a rule as defined in the Congressional Review Act (5 
U.S.C. 801-808). Therefore, the NRC is not required to submit a rule 
report regarding this action under Section 801 of the Congressional 
Review Act.

XII. Compatibility of Agreement State Regulations

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997, 
and published in the Federal Register (62 FR 46517; September 3, 1997), 
this rule is classified as compatibility ``NRC''. Compatibility is not 
required for Category ``NRC'' regulations. The NRC program elements in 
this category are those that relate directly to areas of regulation 
reserved to the NRC by the Atomic Energy Act or the provisions of 10 
CFR, and though an Agreement State may not adopt program elements 
reserved to the NRC, it may wish to inform its licensees of certain 
requirements via a mechanism that is consistent with a particular 
State's administrative procedure laws, but does not confer regulatory 
authority on the State.

XIII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 104-113), requires that Federal agencies use technical standards 
that are developed or adopted by voluntary consensus standards bodies 
unless the use of such a standard is inconsistent with applicable law 
or otherwise impractical. In this direct final rule, the NRC will 
revise the definition of utilization facility found in 10 CFR 50.2 to 
include the proposed SHINE irradiation units. This action does not 
constitute the establishment of a standard that establishes generally 
applicable requirements.

List of Subjects in 10 CFR Part 50

    Antitrust, Classified information, Criminal penalties, Fire 
protection, Intergovernmental relations, Isotopes, Medical isotopes, 
Molybdenum-99, Nuclear materials, Nuclear power plants and reactors, 
Radiation protection, Reactor siting criteria, Reporting and 
recordkeeping requirements, Utilization facility.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting 
the following amendments to 10 CFR part 50.

PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION 
FACILITIES

0
1. The authority citation for 10 CFR part 50 is revised to read as 
follows:


[[Page 62335]]


    Authority:  Atomic Energy Act secs. 11, 102, 103, 104, 105, 147, 
149, 161, 181, 182, 183, 186, 189, 223, 234 (42 U.S.C. 2014, 2132, 
2133, 2134, 2135, 2167, 2169, 2201, 2231, 2232, 2233, 2236, 2239, 
2273, 2282); Energy Reorganization Act secs. 201, 202, 206 (42 
U.S.C. 5841, 5842, 5846); Nuclear Waste Policy Act sec. 306 (42 
U.S.C. 10226); Government Paperwork Elimination Act sec. 1704 (44 
U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-58, 119 
Stat. 194 (2005). Section 50.7 also issued under Pub. L. 95-601, 
sec. 10, as amended by Pub. L. 102-486, sec. 2902 (42 U.S.C. 5851). 
Section 50.10 also issued under Atomic Energy Act secs. 101, 185 (42 
U.S.C. 2131, 2235); National Environmental Policy Act sec. 102 (42 
U.S.C. 4332). Sections 50.13, 50.54(d), and 50.103 also issued under 
Atomic Energy Act sec. 108 (42 U.S.C. 2138).

    Sections 50.23, 50.35, 50.55, and 50.56 also issued under Atomic 
Energy Act sec. 185 (42 U.S.C. 2235). Appendix Q also issued under 
National Environmental Policy Act sec. 102 (42 U.S.C. 4332). 
Sections 50.34 and 50.54 also issued under sec. 204 (42 U.S.C. 
5844). Sections 50.58, 50.91, and 50.92 also issued under Pub. L. 
97-415 (42 U.S.C. 2239). Section 50.78 also issued under Atomic 
Energy Act sec. 122 (42 U.S.C. 2152). Sections 50.80-50.81 also 
issued under Atomic Energy Act sec. 184 (42 U.S.C. 2234).


0
2. In Sec.  50.2, revise the definition of ``utilization facility'' to 
read as follows:


Sec.  50.2  Definitions.

* * * * *
    Utilization facility means:
    (1) Any nuclear reactor other than one designed or used primarily 
for the formation of plutonium or U-233; or
    (2) An accelerator-driven subcritical operating assembly used for 
the irradiation of materials containing special nuclear material and 
described in the application assigned docket number 50-608.

    Dated at Rockville, Maryland, this 9th day of October, 2014.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2014-24732 Filed 10-16-14; 8:45 am]
BILLING CODE 7590-01-P


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