Definition of a Utilization Facility, 62329-62335 [2014-24732]
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Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations
11232(e), 11246 (b) and (c) of Pub. L. 105–
33, 111 Stat. 251; and section 721 of Pub. L.
105–261, 112 Stat. 2061.
2. Section 890.102 is amended by
adding paragraphs (j) and (k) to read as
follows:
■
§ 890.102
Coverage.
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(j)(1) Notwithstanding paragraphs
(c)(1), (2), and (3) of this section, a nonPostal employee working on a
temporary appointment, a non-Postal
employee working on a seasonal
schedule of less than 6 months in a year,
or a non-Postal employee working on an
intermittent schedule, for whom the
employing office expects the total hours
in pay status (including overtime hours)
plus qualifying leave without pay hours
to be at least 130 hours per calendar
month, is eligible to enroll in a health
benefits plan under this part as follows:
(i) If the employing office expects the
employee to work at least 90 days, the
employee is eligible to enroll upon
notification of the employee’s eligibility
by the employing office, and
(ii) If the employing office expects the
employee to work for fewer than 90
days and the employee actually works
for fewer than 90 days, the employee
will generally be ineligible to enroll in
FEHB because the employee will not be
employed at the end of the waiting
period applicable to these employees.
However, if the expectation changes and
the employee is expected to work for 90
days or more, that individual is eligible
to enroll upon notification by the
employing office, but enrollment
(including the effective date of coverage)
must be no later than the end of the
waiting period ending the 91st day after
the first day of employment.
(2) An employee working on a
temporary appointment, an employee
working on a seasonal schedule of less
than 6 months in a year, or an employee
working on an intermittent schedule for
whom the employing office expects the
total hours in pay status (including
overtime hours) plus qualifying leave
without pay hours to be less than 130
hours per calendar month is generally
ineligible to enroll in a health benefits
plan under this part. If the expectation
of hours of employment changes to 130
hours or more per month for a nonPostal employee, that employee is
eligible to enroll in a health benefits
plan under this part as described in
paragraph (j)(1)(i) of this section.
(3) Once an employee is enrolled
under this paragraph (j), eligibility will
not be revoked, regardless of his or her
actual work schedule or employer
expectations in subsequent years, unless
the employee separates from Federal
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service, receives a new appointment (in
which case eligibility will be
determined by the rules applicable to
the new appointment), or exceeds 365
days in nonpay status in accordance
with § 890.303(e) (subject to extension,
if applicable, for qualifying leave
without pay as defined at paragraph
(j)(4) of this section).
(4) For purposes of this paragraph (j),
‘‘qualifying leave without pay hours’’
means hours of leave without pay for
purposes of taking leave under the
Family and Medical Leave Act, for
performance of duty in the uniformed
services under the Uniformed Services
Employment and Reemployment Rights
Act of 1994, 38 U.S.C. 4301 et seq., for
receiving medical treatment under
Executive Order 5396 (Jul. 7 1930), and
for periods during which workers
compensation is received under the
Federal Employees Compensation Act, 5
U.S.C. chapter 81.
(5) Each temporary employee who is
initially eligible for FEHB coverage on
the basis of this paragraph (j) is entitled
to enroll in accordance with
§ 890.301(a). A temporary employee
who is currently eligible under 5 U.S.C.
8906a (with no Government
contribution) but who is not enrolled on
November 17, 2014, and who would
also meet eligibility requirements on the
basis of paragraph (j), is entitled to
enroll (with a Government contribution)
on the basis of paragraph (j) in
accordance with § 890.301(h)(4)(ii). A
temporary employee who is enrolled
under 5 U.S.C. 8906a (with no
Government contribution) on November
17, 2014, and who would also meet
eligibility requirements on the basis of
paragraph (j), is entitled to change
enrollment (with a Government
contribution) on the basis of paragraph
(j) in accordance with
§ 890.301(h)(4)(ii).
(k) The Director, upon written request
of an employer of employees other than
those covered by 5 U.S.C. 8901(1)(A),
may, in his or her sole discretion, waive
application of paragraph (j) of this
section to its employees when the
employer demonstrates to the Director
that the waiver is necessary to avoid an
adverse impact on the employer’s need
to manage its workforce. However, a
Tribal employer participating under 25
U.S.C. 1647b may provide a written
notification to the Director that it has
chosen not to apply paragraph (j) of this
section for its workforce.
■ 3. Amend § 890.301 as follows:
■ a. Revise the heading of paragraph
(h).b. Redesignate paragraph (h)(4) as
paragraph (h)(4)(i).
■ c. Add paragraph (h)(4)(ii).
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62329
The revision and addition read as
follows:
§ 890.301 Opportunities for employees
who are not participants in premium
conversion to enroll or change enrollment;
effective dates.
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(h) Change in employment status or
entitlement to Government contribution.
* * *
(4) * * *
(ii) A change in entitlement to
Government contribution as a result of
becoming eligible for coverage under
§ 890.102(j).
*
*
*
*
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[FR Doc. 2014–24652 Filed 10–14–14; 11:15 am]
BILLING CODE 6325–63–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 50
[NRC–2013–0053]
RIN 3150–AJ18
Definition of a Utilization Facility
Nuclear Regulatory
Commission.
ACTION: Direct final rule.
AGENCY:
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 acceleratordriven 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.
SUMMARY:
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
DATES:
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to ensure consideration only for
comments received on or before this
date.
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:
• Federal Rulemaking Web Site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2013–0053. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–287–3422;
email: Carol.Gallagher@nrc.gov. 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 publiclyavailable documents online in the
ADAMS Public Documents collection at
https://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 pdr.resource@nrc.gov. 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.
• 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: Steven.Lynch@nrc.gov; U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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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?
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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-andcomment 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
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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.
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 § 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
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.
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).
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the Commission on May 11, 2012, that
no rulemaking was required to license
SHINE’s proposed medical isotope
production facility.4
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
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4 Transcript
of NRC Briefing on Potential Medical
Isotope Production Licensing Actions, pages 55–56,
61–62 (May 11, 2012) (ADAMS Accession No.
ML121370084).
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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production facility nor functionally
independent as production facilities.
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 selfsupporting 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
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
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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62331
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 nonpower 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
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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 nonpower 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.
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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 (keff) 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 keff. 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
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thermal power level comparable to nonpower 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 nonpower reactors, including the following:
• Provisions for removal of fission
heat during operation.
• Consideration of decay heat
generation after shutdown.
• Reactivity feedback mechanisms
similar to non-power reactors.
• Control of fission gas release during
operation and subsequent gas
management engineering safety features.
• Control of radiolytic decomposition
of water and generated oxygen and
hydrogen gases.
• Control of fission product inventory
buildup.
• Accident scenarios similar to nonpower reactors, such as loss of coolant,
reactivity additions, and release of
fission products.
Although SHINE’s proposed
irradiation units closely resemble nonpower 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
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.
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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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.
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
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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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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
11 PSAR, Chapter 4—Irradiation Unit and
Radioisotope Production Facility Description (May
31, 2013) (ADAMS Accession No. ML13172A265).
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21:55 Oct 16, 2014
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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
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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62333
units currently described in its PSAR,
the rule would no longer apply to
SHINE, and the NRC staff would pursue
an alternative licensing approach.
As previously explained, because the
irradiation units are similar to nonpower 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.
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Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations
VIII. Plain Writing
IV. Discussion of Amendments by
Section
Section 50.2
Definitions
The definition for utilization facility
will be changed to add: An acceleratordriven 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.
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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.
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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 nonradiological 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.
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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
1. The authority citation for 10 CFR
part 50 is revised to read as follows:
■
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Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations
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).
2. In § 50.2, revise the definition of
‘‘utilization facility’’ to read as follows:
■
§ 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
FEDERAL ELECTION COMMISSION
11 CFR Part 110
[Notice 2014–11]
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Aggregate Biennial Contribution Limits
Federal Election Commission.
Interim final rule.
AGENCY:
ACTION:
The Commission is removing
regulatory limits on the aggregate
amounts that an individual may
contribute to federal candidates and
political committees in each two-year
SUMMARY:
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21:55 Oct 16, 2014
Jkt 235001
election cycle. The Commission is
taking this action in light of the
Supreme Court’s recent decision in
McCutcheon v. FEC, which held that the
aggregate contribution limits are
unconstitutional. The Commission is
accepting comments on these revisions
to its regulations.
DATES: Effective October 17, 2014.
Comments must be received on or
before November 17, 2014.
ADDRESSES: All comments must be in
writing. Comments may be submitted
electronically via the Commission’s
Web site at sers.fec.gov, reference REG
2014–01. Commenters are encouraged to
submit comments electronically to
ensure timely receipt and consideration.
Alternatively, comments may be
submitted in paper form. Paper
comments must be sent to the Federal
Election Commission, Attn.: Amy L.
Rothstein, Assistant General Counsel,
999 E Street NW., Washington, DC
20463. All comments must include the
full name and postal service address of
a commenter, and of each commenter if
filed jointly, or they will not be
considered. The Commission will post
comments on its Web site at the
conclusion of the comment period.
FOR FURTHER INFORMATION CONTACT: Ms.
Amy L. Rothstein, Assistant General
Counsel, or Mr. Theodore M. Lutz,
Attorney, 999 E Street NW.,
Washington, DC 20463, (202) 694–1650
or (800) 424–9530.
SUPPLEMENTARY INFORMATION:
Background
The Federal Election Campaign Act,
52 U.S.C. 30101–46 (formerly 2 U.S.C.
431–57) (‘‘FECA’’), imposes limits on
the aggregate amounts that an
individual may contribute to federal
candidates, political parties, and other
political committees during a two-year
election cycle. 52 U.S.C. 30116(a)(3)
(formerly 2 U.S.C. 441a(a)(3)). The
Commission has implemented FECA’s
aggregate limits in its regulations at 11
CFR 110.5.
On April 2, 2014, the United States
Supreme Court held that the aggregate
contribution limits are unconstitutional.
McCutcheon v. FEC, 572 U.S. l, 134 S.
Ct. 1434 (2014) (plurality op.). To
conform its regulations to the
McCutcheon decision, the Commission
is deleting 11 CFR 110.5 and is making
technical and conforming changes to 11
CFR 110.1(c), 110.14(d) and (g),
110.17(b), and 110.19. In an Advance
Notice of Proposed Rulemaking
published in today’s Federal Register,
the Commission is separately seeking
comment on whether to begin a
rulemaking to revise other regulations in
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62335
light of certain language from the
McCutcheon decision.
The Commission is taking this action
without advance notice and comment
because it falls under the ‘‘good cause’’
exception of the Administrative
Procedure Act (‘‘APA’’), 5 U.S.C.
553(b)(B). The revisions set forth herein
are necessary to conform the
Commission’s regulations to the
Supreme Court’s holding that the
statutory aggregate limits are
unconstitutional. See McCutcheon, 134
S. Ct. at 1442. Because this action does
not involve any Commission discretion
or policy judgments, notice and
comment are unnecessary. 5 U.S.C
553(b)(B), (d)(3). A pre-publication
notice and comment period would also
be contrary to the public interest
because the 2014 election campaigns for
federal office are ongoing, and so the
delay that would result from such a
period might cause confusion among the
public as to the enforceability of the
regulations addressed below.
For the same reasons, these revisions
fall within the ‘‘good cause’’ exception
to the APA’s delayed effective date
provision and the requirements of the
Congressional Review Act. 5 U.S.C.
553(d)(3), 808(2). Moreover, because
this interim final rule is exempt from
the APA’s notice and comment
procedure under 5 U.S.C. 553(b), the
Commission is not required to conduct
a regulatory flexibility analysis under 5
U.S.C. 603 or 604. See 5 U.S.C. 601(2),
604(a). Nor is the Commission required
to submit these revisions for
congressional review under FECA. See
52 U.S.C. 30111(d)(1), (4) (formerly 2
U.S.C. 438(d)(1), (4)) (providing for
congressional review when Commission
‘‘prescribe[s]’’ a ‘‘rule of law’’).
Accordingly, these revisions are
effective upon publication in the
Federal Register.
Explanation and Justification
FECA imposes two types of limits on
the amount that individuals may
contribute in connection with federal
elections. The ‘‘base limits’’ restrict how
much an individual may contribute to a
particular candidate or political
committee per election or calendar year.
See 52 U.S.C. 30116(a)(1) (formerly 2
U.S.C. 441a(a)(1)). The ‘‘aggregate
limits’’ restrict the amounts that an
individual may contribute to all
candidate committees, political party
committees, and other political
committees in each two-year election
cycle. See 52 U.S.C. 30116(a)(3)
(formerly 2 U.S.C. 441a(a)(3)). Under the
aggregate limits, as indexed for inflation
in the 2013–14 election cycle, an
individual could contribute up to
E:\FR\FM\17OCR1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 201 (Friday, October 17, 2014)]
[Rules and Regulations]
[Pages 62329-62335]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24732]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
Federal Rulemaking Web Site: Go to https://www.regulations.gov and search for Docket ID NRC-2013-0053. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: Carol.Gallagher@nrc.gov. 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 ``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 pdr.resource@nrc.gov.
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.
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:
Steven.Lynch@nrc.gov; 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 (keff) 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 keff. 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:
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Provisions for removal of fission heat during operation.
Consideration of decay heat generation after shutdown.
Reactivity feedback mechanisms similar to non-power
reactors.
Control of fission gas release during operation and
subsequent gas management engineering safety features.
Control of radiolytic decomposition of water and generated
oxygen and hydrogen gases.
Control of fission product inventory buildup.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\11\ PSAR, Chapter 4--Irradiation Unit and Radioisotope
Production Facility Description (May 31, 2013) (ADAMS Accession No.
ML13172A265).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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
