List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Amendment No. 9, Revision 1, 371-378 [2015-33280]
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Rules and Regulations
Federal Register
Vol. 81, No. 3
Wednesday, January 6, 2016
This section of the FEDERAL REGISTER
contains regulatory documents having general
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are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
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new books are listed in the first FEDERAL
REGISTER issue of each week.
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 72
[NRC–2015–0156]
RIN 3150–AJ63
List of Approved Spent Fuel Storage
Casks: Holtec International HI–STORM
100 Cask System; Amendment No. 9,
Revision 1
Nuclear Regulatory
Commission.
ACTION: Direct final rule.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is amending its
spent fuel storage regulations by
revising the Holtec International
(‘‘Holtec,’’ or ‘‘the applicant’’) HI–
STORM 100 Cask System listing within
the ‘‘List of Approved Spent Fuel
Storage Casks’’ to include Amendment
No. 9, Revision 1, to Certificate of
Compliance (CoC) No. 1014.
Amendment No. 9, Revision 1, changes
cooling time limits for thimble plug
devices (TPDs), removes certain testing
requirements for the fabrication of
Metamic HT neutron-absorbing
structural material, and reduces certain
minimum guaranteed values (MGV)
used in bounding calculations for this
material. Amendment No. 9, Revision 1,
also changes fuel definitions to classify
certain boiling water reactor (BWR) fuel
within specified guidelines as
undamaged fuel.
DATES: The direct final rule is effective
March 21, 2016, unless significant
adverse comments are received by
February 5, 2016. If the direct final 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is withdrawn as a result of such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 staff is
able to ensure consideration only of
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SUMMARY:
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comments received on or before this
date. Comments received on this direct
final rule will also be considered to be
comments on a companion proposed
rule published in the Proposed Rules
section of this issue of the Federal
Register.
You may submit comments
by any of the following methods (unless
this document describes a different
method for submitting comments on a
specific subject):
• Federal rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2015–0156. Address
questions about NRC dockets to Carol
Gallagher, telephone: 301–415–3463;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Email comments to:
Rulemaking.Comments@nrc.gov. If you
do not receive an automatic email reply
confirming receipt, then contact us at
301–415–1677.
• Fax comments to: Secretary, U.S.
Nuclear Regulatory Commission at 301–
415–1101.
• Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
• Hand deliver comments to: 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
(Eastern Time) Federal workdays;
telephone: 301–415–1677.
For additional direction on obtaining
information and submitting comments,
see ‘‘Obtaining Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Robert D. MacDougall, Office of Nuclear
Material Safety and Safeguards,
telephone: 301–415–5175, email:
Robert.MacDougall@nrc.gov; U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Table of Contents
I. Obtaining Information and Submitting
Comments
II. Procedural Background
III. Background
IV. Discussion of Changes
V. Voluntary Consensus Standards
VI. Agreement State Compatibility
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VII. Plain Writing
VIII. Environmental Assessment and Final
Finding of No Significant Environmental
Impact
IX. Paperwork Reduction Act Statement
X. Regulatory Flexibility Certification
XI. Regulatory Analysis
XII. Backfitting and Issue Finality
XIII. Congressional Review Act
XIV. Availability of Document
I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2015–
0156 when contacting the NRC about
the availability of information for this
action. You may obtain publiclyavailable information related to this
action by any of the following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2015–0156.
• 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, 301–415–4737, or by
email to pdr.resource@nrc.gov. For the
convenience of the reader, instructions
about obtaining materials referenced in
this document are provided in the
‘‘Availability of Documents’’ 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.
B. Submitting Comments
Please include Docket ID NRC–2015–
0156 in the subject line of your
comment submission.
The NRC cautions you not to include
identifying or contact information that
you do not want to be publicly
disclosed in your comment submission.
The NRC will post all comment
submissions at https://
www.regulations.gov as well as enter the
comment submissions into ADAMS.
The NRC does not routinely edit
comment submissions to remove
identifying or contact information.
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If you are requesting or aggregating
comments from other persons for
submission to the NRC, you should
inform those persons not to include
identifying or contact information that
they do not want to be publicly
disclosed in their comment submission.
Your request should state that the NRC
does not routinely edit comment
submissions to remove such information
before making the comment
submissions available to the public or
entering the comment into ADAMS.
II. Procedural Background
This rule is limited to the changes
contained in Amendment No. 9,
Revision 1, to CoC No. 1014 and does
not include other aspects of the Holtec
HI–STORM 100 Cask System design.
The NRC is using the ‘‘direct final rule’’
procedure to issue this amendment
because it represents a limited and
routine change to an existing CoC and
is expected to be noncontroversial.
Adequate protection of public health
and safety continues to be ensured. The
amendment to the rule will become
effective on March 21, 2016. If the NRC
receives significant adverse comments
on this direct final rule by February 5,
2016, the NRC will publish a Federal
Register notice withdrawing the direct
final rule, and will address the
comments in a subsequent Federal
Register notice for a final rule based on
the companion proposed rule published
in the Proposed Rule section of this
issue of the Federal Register. Absent the
need for significant modifications to the
proposed revisions that would require
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 adverse and significant if:
(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, CoC, or Technical
Specifications.
For detailed instructions on filing
comments, please see the ADDRESSES
section of this document.
III. Background
Section 218(a) of the Nuclear Waste
Policy Act (NWPA) of 1982, as
amended, requires that ‘‘the Secretary
[of the U.S. Department of Energy] shall
establish a demonstration program, in
cooperation with the private sector, for
the dry storage of spent nuclear fuel at
civilian nuclear power reactor sites,
with the objective of establishing one or
more technologies that the [U.S. Nuclear
Regulatory] Commission may, by rule,
approve for use at the sites of civilian
nuclear power reactors without, to the
maximum extent practicable, the need
for additional site-specific approvals by
the Commission.’’ Section 133 of the
NWPA states, in part, that ‘‘[t]he
Commission shall, by rule, establish
procedures for the licensing of any
technology approved by the
Commission under Section 219(a) [sic:
218(a)] for use at the site of any civilian
nuclear power reactor.’’
To implement this mandate, the
Commission approved dry storage of
spent nuclear fuel in NRC-approved
casks under a general license by
publishing a final rule to add a new
subpart K in part 72 of title 10 of the
Code of Federal Regulations (10 CFR)
entitled, ‘‘General License for Storage of
Spent Fuel at Power Reactor Sites’’ (55
FR 29181; July 18, 1990). This rule also
established a new subpart L in 10 CFR
part 72 entitled, ‘‘Approval of Spent
Fuel Storage Casks,’’ which contains
procedures and criteria for obtaining
NRC approval of spent fuel storage cask
designs. The NRC subsequently issued a
final rule (65 FR 25241; May 1, 2000)
that approved the HI–STORM 100 Cask
System design and added it to the list
of NRC-approved cask designs in 10
CFR 72.214, ‘‘List of approved spent
fuel storage casks,’’ as CoC No. 1014.
Most recently, the NRC issued a final
rule effective on March 11, 2014 (78 FR
78165), that approved the HI–STORM
100 Cask System design amendment
subject to this rulemaking and added it
to the list of NRC-approved cask designs
in 10 CFR 72.214 as CoC No. 1014,
Amendment No. 9.
IV. Discussion of Changes
On July 1, 2014, Holtec submitted a
request to the NRC to revise CoC No.
1014 to supersede Amendment 9 with
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Amendment 9, Revision 1. Amendment
No. 9, Revision 1, changes cooling time
limits for TPDs, removes certain testing
requirements for the fabrication of
Metamic HT, and reduces certain MGVs
used in bounding calculations for this
material. Amendment No. 9, Revision 1,
also changes fuel definitions to classify
certain boiling water reactor (BWR) fuel
within specified guidelines as
undamaged fuel. The changes to the
CoC and Technical Specifications (TS)
Appendices are identified with
revisions bars in the margin of each
document.
As a revision, the CoC and its
associated TS will supersede the
previous version of the CoC No. 1014,
Amendment No. 9 CoC and its TSs in
their entirety. A revision in lieu of a
new amendment is justified on the
grounds that:
• Equipment for CoC No. 1014,
Amendment No. 9, cask systems has
been placed in service by several
general licensees, all of whom were
made aware of Holtec’s revision request
and supported it;
• No new canisters are being
requested to be added to CoC No. 1014,
Amendment No. 9, cask systems;
• No new systems, components, or
structures are requested to be added to
CoC No. 1014, Amendment No. 9, cask
systems;
• The requested changes have minor
field and administrative implementation
impacts on general licensees; and
• The requested changes are
applicable to CoC No. 1014,
Amendment No. 9, in their entirety.
Each of the applicant’s proposed
changes is discussed below.
1. Reduced Cooling Time Limit for TPDS
The TPDs are a form of non-fuel
hardware inserted into guide tubes used
in some pressurized water reactor
(PWR) fuel assemblies and made
radioactive by exposure to neutrons
during reactor operation. Supporting its
proposal to reduce the cooling time
limits for TPDs, the applicant noted that
TPDs are not considered in any of the
thermal analyses of CoC No. 1014,
Amendment No. 9, so that in order to
comply with this amendment, general
licensees must perform an evaluation
under 10 CFR 72.212 to ensure that
maximum fuel storage decay heat limits
are met. The applicant stated that,
currently, cooling times for TPDs
exposed to typical fuel burnups in a
reactor core are long, preventing many
TPDs from being stored in the dry multipurpose canisters (MPC) that contain
spent fuel and non-fuel hardware with
‘‘activation products,’’ or components or
constituents made radioactive by
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exposure to neutrons in the reactor core.
The applicant proposed to reduce the
required cooling times so that general
license users can have greater flexibility
to store a larger population of TPDs.
The principal activation product from
the irradiation of TPDs in a reactor core
is Cobalt-60 (Co-60), which has a halflife (the time it takes to lose half its
radioactivity) of 5 years. The applicant
calculated that the Co-60 source for a
TPD with a five-year cooling time after
exposure to a fuel burnup of 63,000
megawatt-days per metric ton of
uranium (MWD/MTU) or less is 141
curies. The maximum Co-60 activity of
TPDs is 240 curies. The applicant
selected 141 curies Co-60 as the design
basis Co-60 activity for each TPD, so
that any TPD can be stored in a HI–
STORM MPC so long as the TPD has a
cooling time of 5 years or greater after
a burnup of 63,000 MWD/MTU or less,
as required by the TSs.
The applicant also calculated the dose
rates from a HI–STORM 100 overpack
with an MPC for BWR and for PWR
fuels using allowable burnup and
cooling times from the proposed
Revision 1 to CoC No. 1014,
Amendment No. 9. These calculated
dose rates were less than the allowable
values in the TSs for the currentlyapproved Amendment No. 9.
The NRC staff reviewed the
applicant’s proposed revisions to its
final safety analysis report (FSAR) and
finds that the proposed change would
have no impact on a fuel rod’s internal
pressure or cladding temperatures. The
NRC staff finds the storing of TPDs to be
acceptable because, as non-fuel
components, they present no risk of
rupturing and releasing fission
products, fission product gases, or any
other material detrimental to the
internals of the cask. Nor would the
storage of TPDs prevent the retrieval of
spent fuel from a cask. General licensees
will, however, continue to be required
under 72.212 to evaluate and ensure
that cell heat loads per canister remain
below the applicable limits as listed in
the FSAR and TSs prior to loading.
2. Removing or Revising Certain
Metamic-HT Fabrication Testing
Requirements
Metamic-HT is a neutron-absorbing
structural material used for internal
components of MPCs, which hold spent
fuel assemblies and other radioactive
fuel components inside storage casks.
The applicant proposed changing
Metamic-HT fabrication testing
requirements to: Remove testing using a
1-inch collimated neutron beam; remove
Charpy V-notch and lateral expansion
testing; remove thermal conductivity
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testing; revise testing requirements for
fuel basket welds; change re-testing
criteria when a component fails to meet
an MGV by requiring only the failed
property to be re-tested (not all MGVs);
and add the ability to conduct 100%
testing of an MGV property within a lot
if a sample within the lot fails re-testing.
According to the applicant, these
changes are to improve Metamic-HT
testing, or ease undue burden, because
some testing requirements were overly
conservative and created a lengthy
testing process, while others did not
affect the safety analysis.
The requirement for the use of a 1inch neutron beam is based on Interim
Staff Guidance (ISG)-23, ‘‘Application of
ASTM Standard Practice C1671–07
when performing technical reviews of
spent fuel storage and transportation
packaging licensing actions.’’ ISG–23
concludes that a beam between 1 cm
and 2.54 cm is acceptable for
qualification and acceptance testing of
neutron absorbing materials. The ISG
also states, however, that ‘‘a visual
inspection should be conducted on all
neutron absorbing materials intended
for service,’’ and that as part of that
visual inspection, ‘‘it is important to
ensure that there are no defects that
might lead to problems in service; such
as delaminations or cracks that could
appear on clad neutron absorbing
materials.’’ The staff finds that in this
instance, a visual inspection of all
neutron-absorbing materials intended
for service, along with other fabrication
testing measures called for in ISG–23,
such as minimum plate thickness
testing, will provide adequate assurance
against significant defects in Metamic
HT without the need for neutron beam
testing.
The Charpy V-notch test is a measure
of a given material’s toughness under
impact loading to study temperaturedependent ductile-to-brittle transitions.
As temperature decreases, a metal’s
ability to absorb the energy of an
impact—its ductility—decreases, and at
some temperature, its ductility may
suddenly drop almost to zero. This
sharp transition to brittleness is
essentially unidentified in metals with a
face-centered cubic (FCC) crystal
structure, however, and Metamic-HT is
an aluminum composite with an FCCbased metal matrix. The staff therefore
concludes that the Charpy V-notch test
is not necessary for Metamic-HT.
Proposing to remove the thermal
conductivity testing requirement for
Metamic-HT during fabrication, the
applicant noted that there is little
variability in this material’s thermal
conductivity when fabricated according
to the manufacturing manual.
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The NRC staff evaluated the
applicant’s proposal and finds that the
thermal conductivity of Metamic-HT is
stable for normal operating temperatures
(200 °C to 500 °C), so that removal of
this testing requirement would have no
impact on any of the previously
approved NRC staff evaluations. The
proposed change is therefore considered
acceptable.
The applicant also intends to employ
a new qualified welding process called
Friction Stir Welding (FSW), for
external basket joints. Allowing the use
of FSW of the Metamic HT basket does
not change the safety basis as evaluated
by the staff in HI–STORM 100,
Amendment No. 9, with respect to
basket structural performance. Since the
basket corners utilize the same welded
joint configuration specified in
amendment No. 9 and prior
amendments, the primary consideration
is that of weld process and qualification,
rather than structural performance of
the weld itself.
Based on its review of the application,
the staff determined that the methods
used to qualify the weld joint were
sufficiently robust to demonstrate a
structural performance comparable to
the welding method described in
previous amendments. The loading
conditions and the fully supported
boundary conditions of the peripheral
basket panels result in calculated joint
stresses below their full capacity. The
staff therefore concludes that this
margin accounts for any differences in
welding procedures, should they arise
in the future. The staff’s conclusions in
this regard only apply to the basket
corner welds and shim arrangement
defined by this revision.
3. Changing Minimum Guaranteed
Values for Metamic-HT Analyses
Using the guidance of the American
Society of Mechanical Engineers
(ASME) Section II, Mandatory
Appendix 5, ‘‘Guideline on the
Approval of New Materials Under the
ASME Boiler and Pressure Vessel
Code,’’ Holtec determined the
mechanical properties of Metamic-HT at
ambient and various other higher and
lower temperatures. It then analyzed its
test data using statistical methods to
determine minimum, average, and mean
values of the material’s structural
properties. In addition, the applicant
established a design value MGV for each
of the various properties. An MGV is an
arbitrary value for any given property
below the lowest measured value from
the test data. The MGV is then
demonstrated or guaranteed to be
exceeded for every manufactured lot of
Metamic HT through lot testing.
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The MGVs for Metamic-HT are used
in calculations to demonstrate that
structural components made with this
material will satisfy engineering
requirements, such as stress or
deflection limits to ensure acceptable
hardness of the component in service.
Using MGV values produces a bounding
calculation for any given engineering
requirement.
To support its proposal for reducing
some of these MGVs, Holtec used
differing MGV values in structural
calculations for developing stress/strain
curves from finite element analysis, a
method of computing displacements,
stresses, and strains at defined points
along the length, width, or within a
cross-section of a given component.
Holtec’s calculations determined that
a positive margin of safety for basket
performance criteria remains even with
an average reduction of approximately
10 percent in MGVs for material yield
stress, ultimate strength, and Young’s
modulus, a measure of a material’s
elasticity (ability to resume its original
dimensions) under lengthwise tension
or compression. The applicant also
reported a calculated reduction of 20
percent of the MGV for area criteria
measured during a tensile test. Positive
margins remain in the criteria for peak
stress, maximum deflection, and crack
propagation. These minimum values are
guaranteed to be met by the imposition
of a sampling test plan based on the
standards for critical service parts. The
applicant also proposed to add the
ability to conduct 100 percent testing of
an MGV property within a lot if a
sample fails re-testing.
This is the same change Holtec made
to the HI–STORM 100 Flood/Wind (FW)
Multipurpose MPC Storage System,
CoC—No. 1032 using an acceptable
evaluation that complied with 10 CFR
72.48, ‘‘Changes, tests, and
experiments.’’ The NRC staff reviewed
these results and finds the proposed
changes acceptable, because an
adequate safety margin remains for
basket performance criteria even with
the reduced MGVs.
4. New Spent Fuel Definitions
Holtec proposed to add new
definitions for ‘‘undamaged fuel
assembly,’’ and ‘‘repaired/reconstituted
fuel assembly’’ to provide further clarity
for cask system users and greater
consistency with NRC guidance for
classifying fuel. In addition, the
applicant says that these definitions will
help some BWR users who have older,
low-enriched, channeled BWR fuel with
potential cladding defects that these
users want to load for dry storage
without prior placement in a damaged
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fuel container. A discussion of the
definition changes follows.
4.a. Definition of ‘‘Undamaged Fuel
Assembly’’
The applicant proposed the new
definition for ‘‘undamaged fuel
assembly’’ to read: ‘‘a) a fuel assembly
without known or suspected cladding
defects greater than pinhole leaks or
hairline cracks and that can be handled
by normal means; or b) a BWR fuel
assembly with an intact channel and a
maximum average initial enrichment of
3.3 percent U–235 by weight (wtpercent) that has no known or suspected
grossly breached spent fuel rods and can
be handled by normal means.’’ Under
this definition, an ‘‘undamaged fuel
assembly’’ may be a repaired and
reconstituted fuel assembly.
The applicant noted that with the
currently approved definition,
inspections to classify the fuel cladding
of channeled BWR fuel as undamaged
may be prohibitively costly and/or
unjustifiable for maintaining worker
radiation exposures as low as
reasonably achievable. Holtec also
noted, however, that a particular subset
of older, less-enriched fuel has been
shown to remain subcritical even with
significant cladding damage and
rearrangement of the fuel rods inside the
channel. If this fuel does not have gross
cladding breaches (defined as breaches
larger than pinhole leaks or hairline
cracks), can be handled by normal
means, and has enrichment less than or
equal to 3.3 weight-percent, Holtec
asserted, the fuel does not require a
damaged fuel container and is not
limited to certain basket locations in the
HI–STORM 100 Cask System’s MPC
model 68 designed for BWR fuel.
Under the NRC’s ISG–1, ‘‘Classifying
the Condition of Spent Nuclear Fuel for
Interim Storage and Transportation
Based on Function,’’ undamaged fuel
may contain some cladding defects if it
is safeguarded from high temperatures
and/or oxidation and does not contain
gross cladding breaches. Because HI–
STORM 100 Cask System MPCs are
backfilled with helium and shown to
keep peak fuel cladding temperatures
below the limits in ISG 11, ‘‘Cladding
Considerations for the Transportation
and Storage of Spent Fuel,’’ the staff has
determined that this fuel is protected
during storage from temperatures that
would lead to gross ruptures. Also, as
long as the fuel meets ISG–1 and does
not already contain a gross breach, the
staff concludes that there are no means
for the release of fuel fragments during
storage. In addition, fuel that contains
an assembly defect may be considered
undamaged under ISG–1 if the fuel can
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still meet fuel-specific and systemrelated functions. The NRC staff will
therefore also consider repaired and/or
reconstituted assemblies meeting these
functions as undamaged under the
applicant’s proposed revised definition.
4.b. Definition of ‘‘Repaired/
Reconstituted Fuel Assembly’’
As part of Amendment No. 9,
Revision 1, Holtec proposed a new
definition for a repaired or reconstituted
fuel assembly as one that ‘‘contains
dummy fuel rod(s) that displaces [sic]
an amount of water greater than or equal
to the original fuel rod(s) and/or which
contains structural repairs so it can be
handled by normal means.’’ The
applicant proposed this definition for
clarification purposes and as a subset of
the definition of ‘‘undamaged fuel.’’ It is
a common practice to repair a nuclear
fuel assembly by removing a damaged
fuel rod and replacing it with a dummy
rod to allow the assembly to be returned
to the reactor core. The NRC has
approved this use in specific
applications, and has provided guidance
to 10 CFR part 50 licensees to ensure
that the repair is performed within the
requirements of the licensee’s 10 CFR
part 50 TSs and does not create an
unreviewed safety question. Because a
repaired/reconstituted fuel assembly is
restored to a condition within the
bounds of its original design and safety
analysis, the NRC staff finds this type of
assembly to be a subset of ‘‘undamaged
fuel,’’ and concludes that the applicant’s
proposed definition is consistent with
ISG–1 and therefore acceptable.
5. Conclusions
As documented in its Safety
Evaluation Report (SER), the NRC staff
performed a detailed safety evaluation
of this proposed CoC amendment
request. There are no significant
changes to cask design requirements in
the proposed CoC amendment.
Considering the specific design
requirements for each accident
condition, the design of the cask would
prevent loss of containment, shielding,
and criticality control. If there is no loss
of containment, shielding, or criticality
control, the environmental impacts
would be not be significant. This
amendment does not reflect a significant
change in design or fabrication of the
cask. In addition, any resulting
occupational exposures or offsite dose
rates from the implementation of
Amendment No. 9, Revision 1, would
remain well within 10 CFR part 20
radiation safety limits. Therefore, the
proposed CoC changes will not result in
any radiological or non-radiological
environmental impacts that significantly
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differ from the environmental impacts
evaluated in the environmental
assessment (EA) supporting the May 1,
2000, final rule approving the original
HI–STORM 100 Cask System CoC.
There will be no significant changes in
the types or amounts of any effluent
released, no significant increase in
individual or cumulative radiation
exposures, and no significant increase
in the potential for or consequences of
radiological accidents.
This direct final rule revises the HI–
STORM 100 Cask System listing in 10
CFR 72.214 by adding Amendment No.
9, Revision 1, to CoC No. 1014. The
revision consists of the changes
previously described, as set forth in the
revised CoC and TSs. The revised TSs
are identified in the SER.
The revised HI–STORM 100 Cask
System design, when used under the
conditions specified in the CoC, the
TSs, and the NRC’s regulations, will
meet the requirements of 10 CFR part
72; therefore, adequate protection of
public health and safety will continue to
be ensured. When this direct final rule
becomes effective, persons who hold a
general license under 10 CFR 72.210
may load spent nuclear fuel into HI–
STORM 100 Cask Systems that meet the
criteria of Amendment No. 9, Revision
1, to CoC No. 1014 under 10 CFR
72.212.
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V. Voluntary Consensus Standards
The National Technology Transfer
and Advancement Act of 1995 (Pub. L.
104–113) requires that Federal agencies
use technical standards 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 Holtec HI–STORM 100 Cask
System design listed in § 72.214, ‘‘List
of Approved Spent Fuel Storage Casks.’’
This action does not constitute the
establishment of a standard that
contains generally applicable
requirements.
VI. Agreement State Compatibility
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 on
September 3, 1997 (62 FR 46517), this
rule is classified as Compatibility
Category ‘‘NRC.’’ Compatibility is not
required for Category ‘‘NRC’’
regulations. The NRC program elements
in this category relate directly to areas
of regulation reserved to the NRC by the
Atomic Energy Act of 1954, as amended,
or the provisions of 10 CFR. Although
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an Agreement State may not adopt
program elements reserved to the NRC,
it may wish to inform its licensees of
certain requirements using mechanisms
consistent with the particular State’s
administrative procedure laws, but
classifying an NRC rule as Category
‘‘NRC’’ does not confer regulatory
authority on the State.
VII. 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).
VIII. Environmental Assessment and
Finding of No Significant
Environmental Impact
A. The Action
The action is to amend 10 CFR 72.214
to revise the Holtec HI–STORM 100
Cask System listing within the ‘‘List of
Approved Spent Fuel Storage Casks’’ to
include Amendment No. 9, Revision 1,
to CoC No. 1014. Under the National
Environmental Policy Act (NEPA) of
1969, as amended, and the NRC’s
regulations in subpart A of 10 CFR part
51, ‘‘Environmental Protection
Regulations for Domestic Licensing and
Related Regulatory Functions,’’ the NRC
has determined that this rule, if
adopted, would not be a major Federal
action significantly affecting the quality
of the human environment and,
therefore, an environmental impact
statement (EIS) is not required. The NRC
has made a finding of no significant
impact on the basis of this EA.
B. The Need for the Action
The need for this direct final rule is
to allow users of HI–STORM 100 Cask
Systems under Amendment 9, Revision
1, to load for dry storage under a general
license some PWR fuel assemblies with
shorter cooling times for TPDs, and
some BWR fuel assemblies that would
otherwise have to remain in spent fuel
storage pools. Specifically, Amendment
No. 9, Revision 1, changes cooling time
limits for TPDs, removes certain testing
requirements for the fabrication of
Metamic HT neutron-absorbing
structural material, and reduces certain
MGVs used in bounding calculations for
this material. Amendment No. 9,
Revision 1, also changes fuel definitions
to classify certain BWR fuel within
specified guidelines as undamaged fuel,
which could avert the worker radiation
exposures that would otherwise be
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375
necessary to put this fuel into containers
before loading them into MPCs.
C. Environmental Impacts of the Action
On July 18,1990 (55 FR 29181), the
NRC issued an amendment to 10 CFR
part 72 to provide for the storage of
spent fuel under a general license in
cask designs approved by the NRC. The
potential environmental impact of using
NRC-approved storage casks was
initially analyzed in the EA for the 1990
final rule. The EA for this Amendment
No. 9, Revision 1, tiers off of that EA for
the July 18, 1990, final rule. Tiering on
past environmental assessments is a
standard process under NEPA. As stated
in the Council on Environmental
Quality’s 40 Frequently Asked
Questions, the tiering process makes
each EIS/EA of greater use and meaning
to the public as the plan or program
develops without duplication of the
analysis prepared for the previous
impact statement.
Holtec HI–STORM 100 Cask Systems
are designed to mitigate the effects of
design basis accidents that could occur
during storage. Design basis accidents
account for human-induced events and
the most severe natural phenomena
reported for the site and surrounding
area. Postulated accidents analyzed for
an independent spent fuel storage
installation, the type of facility at which
a holder of a power reactor operating
license would store spent fuel in casks
in accordance with 10 CFR part 72,
include tornado winds and tornadogenerated missiles, a design basis
earthquake, a design basis flood, an
accidental cask drop, lightning effects,
fire, explosions, and other incidents.
Considering the specific design
requirements for each accident
condition, the design of the cask would
prevent loss of confinement, shielding,
and criticality control. If there is no loss
of confinement, shielding, or criticality
control, the environmental impacts
would be insignificant. This revision
does not reflect a significant change in
design or fabrication of the cask. There
are no significant changes to cask design
requirements in the proposed CoC
revision. In addition, because there are
no significant design or process
changes, any resulting occupational
exposures or offsite doses from the
implementation of Amendment No. 9,
Revision 1, would remain well within
10 CFR part 20 radiation protection
limits. Therefore, the proposed CoC
changes will not result in any
radiological or non-radiological
environmental impacts that differ
significantly from the environmental
impacts evaluated in the EA supporting
the July 18, 1990, final rule. There will
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be no significant change in the types or
amounts of any effluent released, no
significant increase in individual or
cumulative radiation exposures, and no
significant increase in the potential for
or consequences of radiological
accidents. The NRC staff documented
these safety findings in the SER.
D. Alternative to the Action
The alternative to this action is to
deny approval of Amendment No. 9,
Revision 1, and end the direct final rule.
Consequently, any 10 CFR part 72
general licensee that seeks to load spent
fuel into a HI–STORM 100 Cask System
in accordance with the changes
described in proposed Amendment No.
9, Revision 1, would have to request an
exemption from the requirements of 10
CFR 72.212 and 72.214. Under this
alternative, interested licensees would
have to prepare, and the NRC would
have to review, each separate exemption
request, thereby increasing the
administrative burden on the NRC and
the costs to each licensee. The
environmental impacts of this no-action
alternative would therefore be the same
as or more than those for the action
itself.
E. Alternative Use of Resources
Approval of Amendment No. 9,
Revision 1, to CoC No. 1014 would
result in no irreversible commitments of
resources.
F. Agencies and Persons Contacted
No agencies or persons outside the
NRC were contacted in connection with
the preparation of this EA.
G. Finding of No Significant Impact
The environmental impacts of the
action have been reviewed as required
by the NRC’s 10 CFR part 51
regulations. Based on the foregoing EA,
the NRC concludes that this direct final
rule entitled, ‘‘List of Approved Spent
Fuel Storage Casks: Holtec International
HI–STORM 100 Cask System;
Amendment No. 9, Revision 1,’’ will not
have a significant effect on the human
environment. Therefore, the NRC has
determined that an EIS for this direct
final rule is not necessary.
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IX. Paperwork Reduction Act
Statement
This rule does not contain any
information collection requirements,
and is therefore not subject to 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
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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.
X. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act
of 1980 (5 U.S.C. 605(b)), the NRC
certifies that this rule will not, if issued,
have a significant economic impact on
a substantial number of small entities.
This direct final rule affects only
nuclear power plant licensees and
Holtec. These entities do not fall within
the definition of small entities set forth
in the Regulatory Flexibility Act or the
size standards established by the NRC
(10 CFR 2.810).
XI. Regulatory Analysis
On July 18, 1990 (55 FR 29181), the
NRC issued an amendment to 10 CFR
part 72 to provide for the storage of
spent nuclear fuel under a general
license in cask designs approved by the
NRC. Any nuclear power reactor
licensee can use NRC-approved cask
designs to store spent nuclear fuel if it
notifies the NRC in advance, the spent
fuel is stored under the conditions
specified in the cask’s CoC, and the
conditions of the general license are
met. A list of NRC-approved cask
designs is provided in 10 CFR 72.214.
On May 1, 2000 (65 FR 25241), the NRC
issued an amendment to 10 CFR part 72
that approved the HI–STORM 100 Cask
System design by adding it to the list of
NRC-approved cask designs in 10 CFR
72.214.
On July 1, 2014, Holtec submitted an
application to revise the HI–STORM 100
Cask System as described in Section III,
‘‘Discussion of Changes,’’ of this
document.
The alternative to this action is to
withhold approval of Amendment No.
9, Revision 1, and to require any 10 CFR
part 72 general licensee seeking to load
spent nuclear fuel into a HI–STORM
100 Cask System under the changes
described in Amendment No. 9,
Revision 1, to request an exemption
from the requirements of 10 CFR 72.212
and 72.214. Under this alternative, each
interested 10 CFR part 72 licensee
would have to prepare, and the NRC
would have to review, a separate
exemption request, thereby increasing
the administrative burden upon the
NRC and the costs to each licensee.
Approval of the direct final rule is
consistent with previous NRC actions.
Further, as documented in the SER and
the EA, the direct final rule will have no
adverse effect on public health and
safety or the environment. This direct
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Fmt 4700
Sfmt 4700
final rule has no significant identifiable
impact or benefit on other Government
agencies. Based on this regulatory
analysis, the NRC concludes that the
requirements of the direct final rule are
commensurate with the NRC’s
responsibilities for public health and
safety and the common defense and
security. No other available alternative
is believed to be as satisfactory, and
therefore, this action is recommended.
XII. Backfitting and Issue Finality
For the reasons set forth below, the
NRC has determined that the backfit
rule (10 CFR 72.62) does not apply to
this direct final rule, and therefore, a
backfit analysis is not required.
This direct final rule revises CoC No.
1014, Amendment No. 9, for the Holtec
HI–STORM 100 Cask System, as
currently listed in 10 CFR 72.214, ‘‘List
of Approved Spent Fuel Storage Casks.’’
Amendment No. 9, Revision 1, reduces
cooling time limits for TPDs in some
fuel assemblies, removes a thermal
conductivity testing requirement for the
fabrication of Metamic HT neutronabsorbing structural material, and
reduces the MGVs used in bounding
calculations for this material.
Amendment No. 9, Revision 1, also
changes fuel definitions to classify
certain BWR fuel within specified
guidelines as undamaged fuel.
According to the certificate holder,
casks have been manufactured under
Amendment No. 9, the subject of this
revision. Although Holtec (applicant,
certificate holder) has manufactured
some casks under the existing CoC No.
1014, Amendment No. 9, that is being
revised by this direct final rule, Holtec,
as the certificate holder, is not subject
to backfitting protection under 10 CFR
72.62. Moreover, Holtec requested the
change and requested to apply it to the
existing casks manufactured under
Amendment No. 9. Therefore, even if
the certificate holder were deemed to be
an entity protected from backfitting, this
request represents a voluntary change
and is not backfitting for Holtec.
Under 10 CFR 72.62, general licensees
are entities that are protected from
backfitting, and in this instance, Holtec
has provided casks under CoC No. 1014,
Amendment No. 9, to general licensees
at the Braidwood, Byron, Farley, Hatch,
and Vogtle reactor facilities. General
licensees are required, pursuant to 10
CFR 72.212, to ensure that each cask
conforms to the terms, conditions, and
specifications of a CoC, and that each
cask can be safely used at the specific
site in question. Because the casks
purchased and delivered under CoC No.
1014 Amendment No. 9, must now be
evaluated under 10 CFR 72.212
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consistent with the revisions in CoC No.
1014 Amendment 9, Revision 1, this
change in the evaluation method and
criteria constitutes a change in a
procedure required to operate an
independent spent fuel storage
installation (ISFSI) and, therefore,
would constitute backfitting under 10
CFR 72.62(a)(2).
In this instance, however, the affected
general licensees voluntarily indicated
their willingness to comply with the
revised CoC. In order to provide these
general licensees adequate time to
implement the revised CoC, it now also
incorporates a condition that provides
general licensees 180 days from the
effective date of Revision 1 to
implement the changes authorized by
this revision and to perform the
required evaluation. Therefore, although
the general licensees are entities that are
protected from backfitting, this request
represents a voluntary change and is not
backfitting for the general licensees.
In addition, the changes in CoC No.
1014, Amendment 9, Revision 1, do not
apply to casks manufactured to the
initial CoC 1014 or subsequent
Amendments of CoC 1014. These
changes therefore have no effect on
current ISFSI general licensees using
casks manufactured to the initial CoC
1014 or other amendments of CoC No.
1014. Thus, the NRC approval of CoC
No. 1014, Amendment No. 9, Revision
1, does not constitute backfitting for
general licensed users of the Holtec HI–
STORM 100 Cask System that were
manufactured to the initial CoC No.
1014 or to other amendments of CoC No.
1014, under 10 CFR 72.62, 10 CFR
50.109(a)(1), or the issue finality
provisions in 10 CFR part 52.
For these reasons, no backfit analysis
or additional documentation addressing
the issue finality criteria in 10 CFR part
52 has been prepared by the NRC.
XIII. Congressional Review Act
The Office of Management and Budget
has not found this to be a major rule as
defined in the Congressional Review
Act.
XIV. Availability of Documents
The documents identified in the
following table are available to
interested persons through one or more
of the following methods, as indicated.
ADAMS
accession No.
Document
Proposed CoC 1014 Amendment No. 9, Revision 1 .......................................................................................................................
Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix A ..........................................................
Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix B ..........................................................
Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix A–100U ................................................
Proposed CoC 1014 Amendment No. 9, Revision 1 Technical Specifications, Appendix B–100U ................................................
Preliminary CoC 1014 Amendment No. 9, Revision 1 Safety Evaluation Report ...........................................................................
Request for Revision Application dated July 1, 2014 ......................................................................................................................
Notification by general licensees of voluntary acceptance of Revision 1 requirements dated August 28, 2015 ............................
Interim Staff Guidance 1, Classifying the Condition of Spent Nuclear Fuel for Interim Storage and Transportation Based on
Function.
Interim Staff Guidance 11, Revision 3, Cladding Considerations for the Transportation and Storage of Spent Fuel ....................
Interim Staff Guidance 23, Application of ASTM Standard Practice C1671–07 when performing technical reviews of spent fuel
storage and transportation packaging licensing actions.
Act of 1982, as amended; and 5 U.S.C.
552 and 553; the NRC adopts the
following amendments to 10 CFR part
72:
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The NRC may post materials related
to this document, including public
comments, on the Federal rulemaking
Web site at https://www.regulations.gov
under Docket ID NRC–2015–0156. The
Federal rulemaking Web site allows you
to receive alerts when changes or
additions occur in a docket folder. To
subscribe: (1) Navigate to the docket
folder (NRC–2015–0156); (2) click the
‘‘Sign up for Email Alerts’’ link; and (3)
enter your email address and select how
frequently you would like to receive
emails (daily, weekly, or monthly).
■
List of Subjects in 10 CFR Part 72
Administrative practice and
procedure, Criminal penalties,
Hazardous waste, Indians,
Intergovernmental relations, Manpower
training programs, Nuclear energy,
Nuclear materials, Occupational safety
and health, Penalties, Radiation
protection, Reporting and recordkeeping
requirements, Security measures, Spent
fuel, Whistleblowing.
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; the Nuclear Waste Policy
Authority: Atomic Energy Act of 1954,
secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182,
183, 184, 186, 187, 189, 223, 234, 274 (42
U.S.C. 2071, 2073, 2077, 2092, 2093, 2095,
2099, 2111, 2201, 2210e, 2232, 2233, 2234,
2236, 2237, 2238, 2273, 2282, 2021); Energy
Reorganization Act of 1974, secs. 201, 202,
206, 211 (42 U.S.C. 5841, 5842, 5846, 5851);
National Environmental Policy Act of 1982,
secs. 117(a), 132, 133, 134, 135, 137, 141,
145(g), 148, 218(a) (42 U.S.C. 10137(a),
10152, 10153, 10154, 10155, 10157, 10161,
10165(g), 10168, 10198(a)); 44 U.S.C. 3504
note.
Section 72.44(g) also issued under Nuclear
Waste Policy Act secs. 142(b) and 148(c), (d)
(42 U.S.C. 10162(b), 10168(c), (d)).
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PART 72—LICENSING
REQUIREMENTS FOR THE
INDEPENDENT STORAGE OF SPENT
NUCLEAR FUEL, HIGH-LEVEL
RADIOACTIVE WASTE, AND
REACTOR-RELATED GREATER THAN
CLASS C WASTE
1. The authority citation for part 72
continues to read as follows:
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ML15156A941
ML15156A956
ML15156A970
ML15156A982
ML15156B000
ML15156B011
ML14182A486
ML15240A233
ML071420268
ML033230335
ML103130171
Section 72.46 also issued under Atomic
Energy Act sec. 189 (42 U.S.C. 2239); Nuclear
Waste Policy Act sec. 134 (42 U.S.C. 10154).
Section 72.96(d) also issued under Nuclear
Waste Policy Act sec. 145(g) (42 U.S.C.
10165(g)).
Subpart J also issued under Nuclear Waste
Policy Act secs. 117(a), 141(h) (42 U.S.C.
10137(a), 10161(h)).
Subpart K also issued under sec. 218(a) (42
U.S.C. 10198).
2. In § 72.214, Certificate of
Compliance No. 1014 is revised to read
as follows:
■
§ 72.214 List of approved spent fuel
storage casks.
*
*
*
*
*
Certificate Number: 1014.
Initial Certificate Effective Date: May
31, 2000.
Amendment Number 1 Effective Date:
July 15, 2002.
Amendment Number 2 Effective Date:
June 7, 2005.
Amendment Number 3 Effective Date:
May 29, 2007.
Amendment Number 4 Effective Date:
January 8, 2008.
Amendment Number 5 Effective Date:
July 14, 2008.
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Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Rules and Regulations
Amendment Number 6 Effective Date:
August 17, 2009.
Amendment Number 7 Effective Date:
December 28, 2009.
Amendment Number 8 Effective Date:
May 2, 2012, as corrected on November
16, 2012 (ADAMS Accession No.
ML12213A170).
Amendment Number 9 Effective Date:
March 11, 2014, superseded by
Amendment Number 9, Revision 1, on
March 21, 2016.
xxxx
Amendment Number 9, Revision 1,
Effective Date: March 21, 2016.
Safety Analysis Report (SAR)
Submitted by: Holtec International.
SAR Title: Final Safety Analysis
Report for the HI–STORM 100 Cask
System.
Docket Number: 72–1014.
Certificate Expiration Date: May 31,
2020.
Model Number: HI–STORM 100.
*
*
*
*
*
Dated at Rockville, Maryland, this 22nd
day of December, 2015.
For the Nuclear Regulatory Commission.
Glenn M. Tracy,
Acting, Executive Director for Operations.
[FR Doc. 2015–33280 Filed 1–5–16; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. FDA–2015–N–4408]
Medical Devices; Obstetrical and
Gynecological Devices; Classification
of the Intravaginal Culture System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying the
intravaginal culture system into class II
(special controls). The special controls
that will apply to the device are
identified in this order and will be part
of the codified language for the
intravaginal culture system’s
classification. The Agency is classifying
the device into class II (special controls)
in order to provide a reasonable
assurance of safety and effectiveness of
the device.
DATES: This order is effective January 6,
2015. The classification was applicable
on November 2, 2015.
FOR FURTHER INFORMATION CONTACT:
Jason Roberts, Center for Devices and
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SUMMARY:
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Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G218, Silver Spring,
MD 20993–0002, 240–402–6400,
jason.roberts@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&CAct,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
PO 00000
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the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA will classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On February 23, 2015, INVO
Bioscience, submitted a request for
classification of the INVOcellTM
Intravaginal Culture System under
section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the
device be classified into class II (Ref. 1).
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request for de novo classification in
order to classify the device under the
criteria for classification set forth in
section 513(a)(1). FDA classifies devices
into class II if general controls by
themselves are insufficient to provide
reasonable assurance of safety and
effectiveness, but there is sufficient
information to establish special controls
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on November 2, 2015, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding § 884.6165 (21 CFR
884.6165).
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for an intravaginal culture
system will need to comply with the
special controls named in this final
order. The device is assigned the generic
name intravaginal culture system, and it
is identified as a prescription device
intended for preparing, holding, and
transferring human gametes or embryos
during intravaginal in vitro fertilization
(IVF) or intravaginal culture procedures.
FDA has identified the following risks
to health associated specifically with
this type of device, as well as the
measures required to mitigate these
risks in table 1:
E:\FR\FM\06JAR1.SGM
06JAR1
Agencies
[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Rules and Regulations]
[Pages 371-378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33280]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 /
Rules and Regulations
[[Page 371]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 72
[NRC-2015-0156]
RIN 3150-AJ63
List of Approved Spent Fuel Storage Casks: Holtec International
HI-STORM 100 Cask System; Amendment No. 9, Revision 1
AGENCY: Nuclear Regulatory Commission.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its
spent fuel storage regulations by revising the Holtec International
(``Holtec,'' or ``the applicant'') HI-STORM 100 Cask System listing
within the ``List of Approved Spent Fuel Storage Casks'' to include
Amendment No. 9, Revision 1, to Certificate of Compliance (CoC) No.
1014. Amendment No. 9, Revision 1, changes cooling time limits for
thimble plug devices (TPDs), removes certain testing requirements for
the fabrication of Metamic HT neutron-absorbing structural material,
and reduces certain minimum guaranteed values (MGV) used in bounding
calculations for this material. Amendment No. 9, Revision 1, also
changes fuel definitions to classify certain boiling water reactor
(BWR) fuel within specified guidelines as undamaged fuel.
DATES: The direct final rule is effective March 21, 2016, unless
significant adverse comments are received by February 5, 2016. If the
direct final 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 staff is able to ensure consideration only of
comments received on or before this date. Comments received on this
direct final rule will also be considered to be comments on a companion
proposed rule published in the Proposed Rules section of this issue of
the Federal Register.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0156. Address
questions about NRC dockets to Carol Gallagher, telephone: 301-415-
3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Email comments to: Rulemaking.Comments@nrc.gov. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Robert D. MacDougall, Office of
Nuclear Material Safety and Safeguards, telephone: 301-415-5175, email:
Robert.MacDougall@nrc.gov; U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Obtaining Information and Submitting Comments
II. Procedural Background
III. Background
IV. Discussion of Changes
V. Voluntary Consensus Standards
VI. Agreement State Compatibility
VII. Plain Writing
VIII. Environmental Assessment and Final Finding of No Significant
Environmental Impact
IX. Paperwork Reduction Act Statement
X. Regulatory Flexibility Certification
XI. Regulatory Analysis
XII. Backfitting and Issue Finality
XIII. Congressional Review Act
XIV. Availability of Document
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2015-0156 when contacting the NRC
about the availability of information for this action. You may obtain
publicly-available information related to this action by any of the
following methods:
Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2015-0156.
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, 301-415-4737, or by email to pdr.resource@nrc.gov. For
the convenience of the reader, instructions about obtaining materials
referenced in this document are provided in the ``Availability of
Documents'' 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.
B. Submitting Comments
Please include Docket ID NRC-2015-0156 in the subject line of your
comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
[[Page 372]]
If you are requesting or aggregating comments from other persons
for submission to the NRC, you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Procedural Background
This rule is limited to the changes contained in Amendment No. 9,
Revision 1, to CoC No. 1014 and does not include other aspects of the
Holtec HI-STORM 100 Cask System design. The NRC is using the ``direct
final rule'' procedure to issue this amendment because it represents a
limited and routine change to an existing CoC and is expected to be
noncontroversial. Adequate protection of public health and safety
continues to be ensured. The amendment to the rule will become
effective on March 21, 2016. If the NRC receives significant adverse
comments on this direct final rule by February 5, 2016, the NRC will
publish a Federal Register notice withdrawing the direct final rule,
and will address the comments in a subsequent Federal Register notice
for a final rule based on the companion proposed rule published in the
Proposed Rule section of this issue of the Federal Register. Absent the
need for significant modifications to the proposed revisions that would
require 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 adverse and significant if:
(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, CoC, or Technical Specifications.
For detailed instructions on filing comments, please see the
ADDRESSES section of this document.
III. Background
Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as
amended, requires that ``the Secretary [of the U.S. Department of
Energy] shall establish a demonstration program, in cooperation with
the private sector, for the dry storage of spent nuclear fuel at
civilian nuclear power reactor sites, with the objective of
establishing one or more technologies that the [U.S. Nuclear
Regulatory] Commission may, by rule, approve for use at the sites of
civilian nuclear power reactors without, to the maximum extent
practicable, the need for additional site-specific approvals by the
Commission.'' Section 133 of the NWPA states, in part, that ``[t]he
Commission shall, by rule, establish procedures for the licensing of
any technology approved by the Commission under Section 219(a) [sic:
218(a)] for use at the site of any civilian nuclear power reactor.''
To implement this mandate, the Commission approved dry storage of
spent nuclear fuel in NRC-approved casks under a general license by
publishing a final rule to add a new subpart K in part 72 of title 10
of the Code of Federal Regulations (10 CFR) entitled, ``General License
for Storage of Spent Fuel at Power Reactor Sites'' (55 FR 29181; July
18, 1990). This rule also established a new subpart L in 10 CFR part 72
entitled, ``Approval of Spent Fuel Storage Casks,'' which contains
procedures and criteria for obtaining NRC approval of spent fuel
storage cask designs. The NRC subsequently issued a final rule (65 FR
25241; May 1, 2000) that approved the HI-STORM 100 Cask System design
and added it to the list of NRC-approved cask designs in 10 CFR 72.214,
``List of approved spent fuel storage casks,'' as CoC No. 1014. Most
recently, the NRC issued a final rule effective on March 11, 2014 (78
FR 78165), that approved the HI-STORM 100 Cask System design amendment
subject to this rulemaking and added it to the list of NRC-approved
cask designs in 10 CFR 72.214 as CoC No. 1014, Amendment No. 9.
IV. Discussion of Changes
On July 1, 2014, Holtec submitted a request to the NRC to revise
CoC No. 1014 to supersede Amendment 9 with Amendment 9, Revision 1.
Amendment No. 9, Revision 1, changes cooling time limits for TPDs,
removes certain testing requirements for the fabrication of Metamic HT,
and reduces certain MGVs used in bounding calculations for this
material. Amendment No. 9, Revision 1, also changes fuel definitions to
classify certain boiling water reactor (BWR) fuel within specified
guidelines as undamaged fuel. The changes to the CoC and Technical
Specifications (TS) Appendices are identified with revisions bars in
the margin of each document.
As a revision, the CoC and its associated TS will supersede the
previous version of the CoC No. 1014, Amendment No. 9 CoC and its TSs
in their entirety. A revision in lieu of a new amendment is justified
on the grounds that:
Equipment for CoC No. 1014, Amendment No. 9, cask systems
has been placed in service by several general licensees, all of whom
were made aware of Holtec's revision request and supported it;
No new canisters are being requested to be added to CoC
No. 1014, Amendment No. 9, cask systems;
No new systems, components, or structures are requested to
be added to CoC No. 1014, Amendment No. 9, cask systems;
The requested changes have minor field and administrative
implementation impacts on general licensees; and
The requested changes are applicable to CoC No. 1014,
Amendment No. 9, in their entirety.
Each of the applicant's proposed changes is discussed below.
1. Reduced Cooling Time Limit for TPDS
The TPDs are a form of non-fuel hardware inserted into guide tubes
used in some pressurized water reactor (PWR) fuel assemblies and made
radioactive by exposure to neutrons during reactor operation.
Supporting its proposal to reduce the cooling time limits for TPDs, the
applicant noted that TPDs are not considered in any of the thermal
analyses of CoC No. 1014, Amendment No. 9, so that in order to comply
with this amendment, general licensees must perform an evaluation under
10 CFR 72.212 to ensure that maximum fuel storage decay heat limits are
met. The applicant stated that, currently, cooling times for TPDs
exposed to typical fuel burnups in a reactor core are long, preventing
many TPDs from being stored in the dry multi-purpose canisters (MPC)
that contain spent fuel and non-fuel hardware with ``activation
products,'' or components or constituents made radioactive by
[[Page 373]]
exposure to neutrons in the reactor core. The applicant proposed to
reduce the required cooling times so that general license users can
have greater flexibility to store a larger population of TPDs.
The principal activation product from the irradiation of TPDs in a
reactor core is Cobalt-60 (Co-60), which has a half-life (the time it
takes to lose half its radioactivity) of 5 years. The applicant
calculated that the Co-60 source for a TPD with a five-year cooling
time after exposure to a fuel burnup of 63,000 megawatt-days per metric
ton of uranium (MWD/MTU) or less is 141 curies. The maximum Co-60
activity of TPDs is 240 curies. The applicant selected 141 curies Co-60
as the design basis Co-60 activity for each TPD, so that any TPD can be
stored in a HI-STORM MPC so long as the TPD has a cooling time of 5
years or greater after a burnup of 63,000 MWD/MTU or less, as required
by the TSs.
The applicant also calculated the dose rates from a HI-STORM 100
overpack with an MPC for BWR and for PWR fuels using allowable burnup
and cooling times from the proposed Revision 1 to CoC No. 1014,
Amendment No. 9. These calculated dose rates were less than the
allowable values in the TSs for the currently-approved Amendment No. 9.
The NRC staff reviewed the applicant's proposed revisions to its
final safety analysis report (FSAR) and finds that the proposed change
would have no impact on a fuel rod's internal pressure or cladding
temperatures. The NRC staff finds the storing of TPDs to be acceptable
because, as non-fuel components, they present no risk of rupturing and
releasing fission products, fission product gases, or any other
material detrimental to the internals of the cask. Nor would the
storage of TPDs prevent the retrieval of spent fuel from a cask.
General licensees will, however, continue to be required under 72.212
to evaluate and ensure that cell heat loads per canister remain below
the applicable limits as listed in the FSAR and TSs prior to loading.
2. Removing or Revising Certain Metamic-HT Fabrication Testing
Requirements
Metamic-HT is a neutron-absorbing structural material used for
internal components of MPCs, which hold spent fuel assemblies and other
radioactive fuel components inside storage casks. The applicant
proposed changing Metamic-HT fabrication testing requirements to:
Remove testing using a 1-inch collimated neutron beam; remove Charpy V-
notch and lateral expansion testing; remove thermal conductivity
testing; revise testing requirements for fuel basket welds; change re-
testing criteria when a component fails to meet an MGV by requiring
only the failed property to be re-tested (not all MGVs); and add the
ability to conduct 100% testing of an MGV property within a lot if a
sample within the lot fails re-testing. According to the applicant,
these changes are to improve Metamic-HT testing, or ease undue burden,
because some testing requirements were overly conservative and created
a lengthy testing process, while others did not affect the safety
analysis.
The requirement for the use of a 1-inch neutron beam is based on
Interim Staff Guidance (ISG)-23, ``Application of ASTM Standard
Practice C1671-07 when performing technical reviews of spent fuel
storage and transportation packaging licensing actions.'' ISG-23
concludes that a beam between 1 cm and 2.54 cm is acceptable for
qualification and acceptance testing of neutron absorbing materials.
The ISG also states, however, that ``a visual inspection should be
conducted on all neutron absorbing materials intended for service,''
and that as part of that visual inspection, ``it is important to ensure
that there are no defects that might lead to problems in service; such
as delaminations or cracks that could appear on clad neutron absorbing
materials.'' The staff finds that in this instance, a visual inspection
of all neutron-absorbing materials intended for service, along with
other fabrication testing measures called for in ISG-23, such as
minimum plate thickness testing, will provide adequate assurance
against significant defects in Metamic HT without the need for neutron
beam testing.
The Charpy V-notch test is a measure of a given material's
toughness under impact loading to study temperature-dependent ductile-
to-brittle transitions. As temperature decreases, a metal's ability to
absorb the energy of an impact--its ductility--decreases, and at some
temperature, its ductility may suddenly drop almost to zero. This sharp
transition to brittleness is essentially unidentified in metals with a
face-centered cubic (FCC) crystal structure, however, and Metamic-HT is
an aluminum composite with an FCC-based metal matrix. The staff
therefore concludes that the Charpy V-notch test is not necessary for
Metamic-HT.
Proposing to remove the thermal conductivity testing requirement
for Metamic-HT during fabrication, the applicant noted that there is
little variability in this material's thermal conductivity when
fabricated according to the manufacturing manual.
The NRC staff evaluated the applicant's proposal and finds that the
thermal conductivity of Metamic-HT is stable for normal operating
temperatures (200 [deg]C to 500 [deg]C), so that removal of this
testing requirement would have no impact on any of the previously
approved NRC staff evaluations. The proposed change is therefore
considered acceptable.
The applicant also intends to employ a new qualified welding
process called Friction Stir Welding (FSW), for external basket joints.
Allowing the use of FSW of the Metamic HT basket does not change the
safety basis as evaluated by the staff in HI-STORM 100, Amendment No.
9, with respect to basket structural performance. Since the basket
corners utilize the same welded joint configuration specified in
amendment No. 9 and prior amendments, the primary consideration is that
of weld process and qualification, rather than structural performance
of the weld itself.
Based on its review of the application, the staff determined that
the methods used to qualify the weld joint were sufficiently robust to
demonstrate a structural performance comparable to the welding method
described in previous amendments. The loading conditions and the fully
supported boundary conditions of the peripheral basket panels result in
calculated joint stresses below their full capacity. The staff
therefore concludes that this margin accounts for any differences in
welding procedures, should they arise in the future. The staff's
conclusions in this regard only apply to the basket corner welds and
shim arrangement defined by this revision.
3. Changing Minimum Guaranteed Values for Metamic-HT Analyses
Using the guidance of the American Society of Mechanical Engineers
(ASME) Section II, Mandatory Appendix 5, ``Guideline on the Approval of
New Materials Under the ASME Boiler and Pressure Vessel Code,'' Holtec
determined the mechanical properties of Metamic-HT at ambient and
various other higher and lower temperatures. It then analyzed its test
data using statistical methods to determine minimum, average, and mean
values of the material's structural properties. In addition, the
applicant established a design value MGV for each of the various
properties. An MGV is an arbitrary value for any given property below
the lowest measured value from the test data. The MGV is then
demonstrated or guaranteed to be exceeded for every manufactured lot of
Metamic HT through lot testing.
[[Page 374]]
The MGVs for Metamic-HT are used in calculations to demonstrate
that structural components made with this material will satisfy
engineering requirements, such as stress or deflection limits to ensure
acceptable hardness of the component in service. Using MGV values
produces a bounding calculation for any given engineering requirement.
To support its proposal for reducing some of these MGVs, Holtec
used differing MGV values in structural calculations for developing
stress/strain curves from finite element analysis, a method of
computing displacements, stresses, and strains at defined points along
the length, width, or within a cross-section of a given component.
Holtec's calculations determined that a positive margin of safety
for basket performance criteria remains even with an average reduction
of approximately 10 percent in MGVs for material yield stress, ultimate
strength, and Young's modulus, a measure of a material's elasticity
(ability to resume its original dimensions) under lengthwise tension or
compression. The applicant also reported a calculated reduction of 20
percent of the MGV for area criteria measured during a tensile test.
Positive margins remain in the criteria for peak stress, maximum
deflection, and crack propagation. These minimum values are guaranteed
to be met by the imposition of a sampling test plan based on the
standards for critical service parts. The applicant also proposed to
add the ability to conduct 100 percent testing of an MGV property
within a lot if a sample fails re-testing.
This is the same change Holtec made to the HI-STORM 100 Flood/Wind
(FW) Multipurpose MPC Storage System, CoC--No. 1032 using an acceptable
evaluation that complied with 10 CFR 72.48, ``Changes, tests, and
experiments.'' The NRC staff reviewed these results and finds the
proposed changes acceptable, because an adequate safety margin remains
for basket performance criteria even with the reduced MGVs.
4. New Spent Fuel Definitions
Holtec proposed to add new definitions for ``undamaged fuel
assembly,'' and ``repaired/reconstituted fuel assembly'' to provide
further clarity for cask system users and greater consistency with NRC
guidance for classifying fuel. In addition, the applicant says that
these definitions will help some BWR users who have older, low-
enriched, channeled BWR fuel with potential cladding defects that these
users want to load for dry storage without prior placement in a damaged
fuel container. A discussion of the definition changes follows.
4.a. Definition of ``Undamaged Fuel Assembly''
The applicant proposed the new definition for ``undamaged fuel
assembly'' to read: ``a) a fuel assembly without known or suspected
cladding defects greater than pinhole leaks or hairline cracks and that
can be handled by normal means; or b) a BWR fuel assembly with an
intact channel and a maximum average initial enrichment of 3.3 percent
U-235 by weight (wt-percent) that has no known or suspected grossly
breached spent fuel rods and can be handled by normal means.'' Under
this definition, an ``undamaged fuel assembly'' may be a repaired and
reconstituted fuel assembly.
The applicant noted that with the currently approved definition,
inspections to classify the fuel cladding of channeled BWR fuel as
undamaged may be prohibitively costly and/or unjustifiable for
maintaining worker radiation exposures as low as reasonably achievable.
Holtec also noted, however, that a particular subset of older, less-
enriched fuel has been shown to remain subcritical even with
significant cladding damage and rearrangement of the fuel rods inside
the channel. If this fuel does not have gross cladding breaches
(defined as breaches larger than pinhole leaks or hairline cracks), can
be handled by normal means, and has enrichment less than or equal to
3.3 weight-percent, Holtec asserted, the fuel does not require a
damaged fuel container and is not limited to certain basket locations
in the HI-STORM 100 Cask System's MPC model 68 designed for BWR fuel.
Under the NRC's ISG-1, ``Classifying the Condition of Spent Nuclear
Fuel for Interim Storage and Transportation Based on Function,''
undamaged fuel may contain some cladding defects if it is safeguarded
from high temperatures and/or oxidation and does not contain gross
cladding breaches. Because HI-STORM 100 Cask System MPCs are backfilled
with helium and shown to keep peak fuel cladding temperatures below the
limits in ISG 11, ``Cladding Considerations for the Transportation and
Storage of Spent Fuel,'' the staff has determined that this fuel is
protected during storage from temperatures that would lead to gross
ruptures. Also, as long as the fuel meets ISG-1 and does not already
contain a gross breach, the staff concludes that there are no means for
the release of fuel fragments during storage. In addition, fuel that
contains an assembly defect may be considered undamaged under ISG-1 if
the fuel can still meet fuel-specific and system-related functions. The
NRC staff will therefore also consider repaired and/or reconstituted
assemblies meeting these functions as undamaged under the applicant's
proposed revised definition.
4.b. Definition of ``Repaired/Reconstituted Fuel Assembly''
As part of Amendment No. 9, Revision 1, Holtec proposed a new
definition for a repaired or reconstituted fuel assembly as one that
``contains dummy fuel rod(s) that displaces [sic] an amount of water
greater than or equal to the original fuel rod(s) and/or which contains
structural repairs so it can be handled by normal means.'' The
applicant proposed this definition for clarification purposes and as a
subset of the definition of ``undamaged fuel.'' It is a common practice
to repair a nuclear fuel assembly by removing a damaged fuel rod and
replacing it with a dummy rod to allow the assembly to be returned to
the reactor core. The NRC has approved this use in specific
applications, and has provided guidance to 10 CFR part 50 licensees to
ensure that the repair is performed within the requirements of the
licensee's 10 CFR part 50 TSs and does not create an unreviewed safety
question. Because a repaired/reconstituted fuel assembly is restored to
a condition within the bounds of its original design and safety
analysis, the NRC staff finds this type of assembly to be a subset of
``undamaged fuel,'' and concludes that the applicant's proposed
definition is consistent with ISG-1 and therefore acceptable.
5. Conclusions
As documented in its Safety Evaluation Report (SER), the NRC staff
performed a detailed safety evaluation of this proposed CoC amendment
request. There are no significant changes to cask design requirements
in the proposed CoC amendment. Considering the specific design
requirements for each accident condition, the design of the cask would
prevent loss of containment, shielding, and criticality control. If
there is no loss of containment, shielding, or criticality control, the
environmental impacts would be not be significant. This amendment does
not reflect a significant change in design or fabrication of the cask.
In addition, any resulting occupational exposures or offsite dose rates
from the implementation of Amendment No. 9, Revision 1, would remain
well within 10 CFR part 20 radiation safety limits. Therefore, the
proposed CoC changes will not result in any radiological or non-
radiological environmental impacts that significantly
[[Page 375]]
differ from the environmental impacts evaluated in the environmental
assessment (EA) supporting the May 1, 2000, final rule approving the
original HI-STORM 100 Cask System CoC. There will be no significant
changes in the types or amounts of any effluent released, no
significant increase in individual or cumulative radiation exposures,
and no significant increase in the potential for or consequences of
radiological accidents.
This direct final rule revises the HI-STORM 100 Cask System listing
in 10 CFR 72.214 by adding Amendment No. 9, Revision 1, to CoC No.
1014. The revision consists of the changes previously described, as set
forth in the revised CoC and TSs. The revised TSs are identified in the
SER.
The revised HI-STORM 100 Cask System design, when used under the
conditions specified in the CoC, the TSs, and the NRC's regulations,
will meet the requirements of 10 CFR part 72; therefore, adequate
protection of public health and safety will continue to be ensured.
When this direct final rule becomes effective, persons who hold a
general license under 10 CFR 72.210 may load spent nuclear fuel into
HI-STORM 100 Cask Systems that meet the criteria of Amendment No. 9,
Revision 1, to CoC No. 1014 under 10 CFR 72.212.
V. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995 (Pub.
L. 104-113) requires that Federal agencies use technical standards
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 Holtec
HI-STORM 100 Cask System design listed in Sec. 72.214, ``List of
Approved Spent Fuel Storage Casks.'' This action does not constitute
the establishment of a standard that contains generally applicable
requirements.
VI. Agreement State Compatibility
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 on September 3, 1997 (62 FR
46517), this rule is classified as Compatibility Category ``NRC.''
Compatibility is not required for Category ``NRC'' regulations. The NRC
program elements in this category relate directly to areas of
regulation reserved to the NRC by the Atomic Energy Act of 1954, as
amended, or the provisions of 10 CFR. Although an Agreement State may
not adopt program elements reserved to the NRC, it may wish to inform
its licensees of certain requirements using mechanisms consistent with
the particular State's administrative procedure laws, but classifying
an NRC rule as Category ``NRC'' does not confer regulatory authority on
the State.
VII. 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).
VIII. Environmental Assessment and Finding of No Significant
Environmental Impact
A. The Action
The action is to amend 10 CFR 72.214 to revise the Holtec HI-STORM
100 Cask System listing within the ``List of Approved Spent Fuel
Storage Casks'' to include Amendment No. 9, Revision 1, to CoC No.
1014. Under the National Environmental Policy Act (NEPA) of 1969, as
amended, and the NRC's regulations in subpart A of 10 CFR part 51,
``Environmental Protection Regulations for Domestic Licensing and
Related Regulatory Functions,'' the NRC has determined that this rule,
if adopted, would not be a major Federal action significantly affecting
the quality of the human environment and, therefore, an environmental
impact statement (EIS) is not required. The NRC has made a finding of
no significant impact on the basis of this EA.
B. The Need for the Action
The need for this direct final rule is to allow users of HI-STORM
100 Cask Systems under Amendment 9, Revision 1, to load for dry storage
under a general license some PWR fuel assemblies with shorter cooling
times for TPDs, and some BWR fuel assemblies that would otherwise have
to remain in spent fuel storage pools. Specifically, Amendment No. 9,
Revision 1, changes cooling time limits for TPDs, removes certain
testing requirements for the fabrication of Metamic HT neutron-
absorbing structural material, and reduces certain MGVs used in
bounding calculations for this material. Amendment No. 9, Revision 1,
also changes fuel definitions to classify certain BWR fuel within
specified guidelines as undamaged fuel, which could avert the worker
radiation exposures that would otherwise be necessary to put this fuel
into containers before loading them into MPCs.
C. Environmental Impacts of the Action
On July 18,1990 (55 FR 29181), the NRC issued an amendment to 10
CFR part 72 to provide for the storage of spent fuel under a general
license in cask designs approved by the NRC. The potential
environmental impact of using NRC-approved storage casks was initially
analyzed in the EA for the 1990 final rule. The EA for this Amendment
No. 9, Revision 1, tiers off of that EA for the July 18, 1990, final
rule. Tiering on past environmental assessments is a standard process
under NEPA. As stated in the Council on Environmental Quality's 40
Frequently Asked Questions, the tiering process makes each EIS/EA of
greater use and meaning to the public as the plan or program develops
without duplication of the analysis prepared for the previous impact
statement.
Holtec HI-STORM 100 Cask Systems are designed to mitigate the
effects of design basis accidents that could occur during storage.
Design basis accidents account for human-induced events and the most
severe natural phenomena reported for the site and surrounding area.
Postulated accidents analyzed for an independent spent fuel storage
installation, the type of facility at which a holder of a power reactor
operating license would store spent fuel in casks in accordance with 10
CFR part 72, include tornado winds and tornado-generated missiles, a
design basis earthquake, a design basis flood, an accidental cask drop,
lightning effects, fire, explosions, and other incidents.
Considering the specific design requirements for each accident
condition, the design of the cask would prevent loss of confinement,
shielding, and criticality control. If there is no loss of confinement,
shielding, or criticality control, the environmental impacts would be
insignificant. This revision does not reflect a significant change in
design or fabrication of the cask. There are no significant changes to
cask design requirements in the proposed CoC revision. In addition,
because there are no significant design or process changes, any
resulting occupational exposures or offsite doses from the
implementation of Amendment No. 9, Revision 1, would remain well within
10 CFR part 20 radiation protection limits. Therefore, the proposed CoC
changes will not result in any radiological or non-radiological
environmental impacts that differ significantly from the environmental
impacts evaluated in the EA supporting the July 18, 1990, final rule.
There will
[[Page 376]]
be no significant change in the types or amounts of any effluent
released, no significant increase in individual or cumulative radiation
exposures, and no significant increase in the potential for or
consequences of radiological accidents. The NRC staff documented these
safety findings in the SER.
D. Alternative to the Action
The alternative to this action is to deny approval of Amendment No.
9, Revision 1, and end the direct final rule. Consequently, any 10 CFR
part 72 general licensee that seeks to load spent fuel into a HI-STORM
100 Cask System in accordance with the changes described in proposed
Amendment No. 9, Revision 1, would have to request an exemption from
the requirements of 10 CFR 72.212 and 72.214. Under this alternative,
interested licensees would have to prepare, and the NRC would have to
review, each separate exemption request, thereby increasing the
administrative burden on the NRC and the costs to each licensee. The
environmental impacts of this no-action alternative would therefore be
the same as or more than those for the action itself.
E. Alternative Use of Resources
Approval of Amendment No. 9, Revision 1, to CoC No. 1014 would
result in no irreversible commitments of resources.
F. Agencies and Persons Contacted
No agencies or persons outside the NRC were contacted in connection
with the preparation of this EA.
G. Finding of No Significant Impact
The environmental impacts of the action have been reviewed as
required by the NRC's 10 CFR part 51 regulations. Based on the
foregoing EA, the NRC concludes that this direct final rule entitled,
``List of Approved Spent Fuel Storage Casks: Holtec International HI-
STORM 100 Cask System; Amendment No. 9, Revision 1,'' will not have a
significant effect on the human environment. Therefore, the NRC has
determined that an EIS for this direct final rule is not necessary.
IX. Paperwork Reduction Act Statement
This rule does not contain any information collection requirements,
and is therefore not subject to 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.
X. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the
NRC certifies that this rule will not, if issued, have a significant
economic impact on a substantial number of small entities. This direct
final rule affects only nuclear power plant licensees and Holtec. These
entities do not fall within the definition of small entities set forth
in the Regulatory Flexibility Act or the size standards established by
the NRC (10 CFR 2.810).
XI. Regulatory Analysis
On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10
CFR part 72 to provide for the storage of spent nuclear fuel under a
general license in cask designs approved by the NRC. Any nuclear power
reactor licensee can use NRC-approved cask designs to store spent
nuclear fuel if it notifies the NRC in advance, the spent fuel is
stored under the conditions specified in the cask's CoC, and the
conditions of the general license are met. A list of NRC-approved cask
designs is provided in 10 CFR 72.214. On May 1, 2000 (65 FR 25241), the
NRC issued an amendment to 10 CFR part 72 that approved the HI-STORM
100 Cask System design by adding it to the list of NRC-approved cask
designs in 10 CFR 72.214.
On July 1, 2014, Holtec submitted an application to revise the HI-
STORM 100 Cask System as described in Section III, ``Discussion of
Changes,'' of this document.
The alternative to this action is to withhold approval of Amendment
No. 9, Revision 1, and to require any 10 CFR part 72 general licensee
seeking to load spent nuclear fuel into a HI-STORM 100 Cask System
under the changes described in Amendment No. 9, Revision 1, to request
an exemption from the requirements of 10 CFR 72.212 and 72.214. Under
this alternative, each interested 10 CFR part 72 licensee would have to
prepare, and the NRC would have to review, a separate exemption
request, thereby increasing the administrative burden upon the NRC and
the costs to each licensee.
Approval of the direct final rule is consistent with previous NRC
actions. Further, as documented in the SER and the EA, the direct final
rule will have no adverse effect on public health and safety or the
environment. This direct final rule has no significant identifiable
impact or benefit on other Government agencies. Based on this
regulatory analysis, the NRC concludes that the requirements of the
direct final rule are commensurate with the NRC's responsibilities for
public health and safety and the common defense and security. No other
available alternative is believed to be as satisfactory, and therefore,
this action is recommended.
XII. Backfitting and Issue Finality
For the reasons set forth below, the NRC has determined that the
backfit rule (10 CFR 72.62) does not apply to this direct final rule,
and therefore, a backfit analysis is not required.
This direct final rule revises CoC No. 1014, Amendment No. 9, for
the Holtec HI-STORM 100 Cask System, as currently listed in 10 CFR
72.214, ``List of Approved Spent Fuel Storage Casks.'' Amendment No. 9,
Revision 1, reduces cooling time limits for TPDs in some fuel
assemblies, removes a thermal conductivity testing requirement for the
fabrication of Metamic HT neutron-absorbing structural material, and
reduces the MGVs used in bounding calculations for this material.
Amendment No. 9, Revision 1, also changes fuel definitions to classify
certain BWR fuel within specified guidelines as undamaged fuel.
According to the certificate holder, casks have been manufactured
under Amendment No. 9, the subject of this revision. Although Holtec
(applicant, certificate holder) has manufactured some casks under the
existing CoC No. 1014, Amendment No. 9, that is being revised by this
direct final rule, Holtec, as the certificate holder, is not subject to
backfitting protection under 10 CFR 72.62. Moreover, Holtec requested
the change and requested to apply it to the existing casks manufactured
under Amendment No. 9. Therefore, even if the certificate holder were
deemed to be an entity protected from backfitting, this request
represents a voluntary change and is not backfitting for Holtec.
Under 10 CFR 72.62, general licensees are entities that are
protected from backfitting, and in this instance, Holtec has provided
casks under CoC No. 1014, Amendment No. 9, to general licensees at the
Braidwood, Byron, Farley, Hatch, and Vogtle reactor facilities. General
licensees are required, pursuant to 10 CFR 72.212, to ensure that each
cask conforms to the terms, conditions, and specifications of a CoC,
and that each cask can be safely used at the specific site in question.
Because the casks purchased and delivered under CoC No. 1014 Amendment
No. 9, must now be evaluated under 10 CFR 72.212
[[Page 377]]
consistent with the revisions in CoC No. 1014 Amendment 9, Revision 1,
this change in the evaluation method and criteria constitutes a change
in a procedure required to operate an independent spent fuel storage
installation (ISFSI) and, therefore, would constitute backfitting under
10 CFR 72.62(a)(2).
In this instance, however, the affected general licensees
voluntarily indicated their willingness to comply with the revised CoC.
In order to provide these general licensees adequate time to implement
the revised CoC, it now also incorporates a condition that provides
general licensees 180 days from the effective date of Revision 1 to
implement the changes authorized by this revision and to perform the
required evaluation. Therefore, although the general licensees are
entities that are protected from backfitting, this request represents a
voluntary change and is not backfitting for the general licensees.
In addition, the changes in CoC No. 1014, Amendment 9, Revision 1,
do not apply to casks manufactured to the initial CoC 1014 or
subsequent Amendments of CoC 1014. These changes therefore have no
effect on current ISFSI general licensees using casks manufactured to
the initial CoC 1014 or other amendments of CoC No. 1014. Thus, the NRC
approval of CoC No. 1014, Amendment No. 9, Revision 1, does not
constitute backfitting for general licensed users of the Holtec HI-
STORM 100 Cask System that were manufactured to the initial CoC No.
1014 or to other amendments of CoC No. 1014, under 10 CFR 72.62, 10 CFR
50.109(a)(1), or the issue finality provisions in 10 CFR part 52.
For these reasons, no backfit analysis or additional documentation
addressing the issue finality criteria in 10 CFR part 52 has been
prepared by the NRC.
XIII. Congressional Review Act
The Office of Management and Budget has not found this to be a
major rule as defined in the Congressional Review Act.
XIV. Availability of Documents
The documents identified in the following table are available to
interested persons through one or more of the following methods, as
indicated.
------------------------------------------------------------------------
Document ADAMS accession No.
------------------------------------------------------------------------
Proposed CoC 1014 Amendment No. 9, Revision 1 ML15156A941
Proposed CoC 1014 Amendment No. 9, Revision 1 ML15156A956
Technical Specifications, Appendix A.
Proposed CoC 1014 Amendment No. 9, Revision 1 ML15156A970
Technical Specifications, Appendix B.
Proposed CoC 1014 Amendment No. 9, Revision 1 ML15156A982
Technical Specifications, Appendix A-100U.
Proposed CoC 1014 Amendment No. 9, Revision 1 ML15156B000
Technical Specifications, Appendix B-100U.
Preliminary CoC 1014 Amendment No. 9, ML15156B011
Revision 1 Safety Evaluation Report.
Request for Revision Application dated July ML14182A486
1, 2014.
Notification by general licensees of ML15240A233
voluntary acceptance of Revision 1
requirements dated August 28, 2015.
Interim Staff Guidance 1, Classifying the ML071420268
Condition of Spent Nuclear Fuel for Interim
Storage and Transportation Based on Function.
Interim Staff Guidance 11, Revision 3, ML033230335
Cladding Considerations for the
Transportation and Storage of Spent Fuel.
Interim Staff Guidance 23, Application of ML103130171
ASTM Standard Practice C1671-07 when
performing technical reviews of spent fuel
storage and transportation packaging
licensing actions.
------------------------------------------------------------------------
The NRC may post materials related to this document, including
public comments, on the Federal rulemaking Web site at https://www.regulations.gov under Docket ID NRC-2015-0156. The Federal
rulemaking Web site allows you to receive alerts when changes or
additions occur in a docket folder. To subscribe: (1) Navigate to the
docket folder (NRC-2015-0156); (2) click the ``Sign up for Email
Alerts'' link; and (3) enter your email address and select how
frequently you would like to receive emails (daily, weekly, or
monthly).
List of Subjects in 10 CFR Part 72
Administrative practice and procedure, Criminal penalties,
Hazardous waste, Indians, Intergovernmental relations, Manpower
training programs, Nuclear energy, Nuclear materials, Occupational
safety and health, Penalties, Radiation protection, Reporting and
recordkeeping requirements, Security measures, Spent fuel,
Whistleblowing.
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; the Nuclear Waste Policy Act of 1982, as
amended; and 5 U.S.C. 552 and 553; the NRC adopts the following
amendments to 10 CFR part 72:
PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF
SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-
RELATED GREATER THAN CLASS C WASTE
0
1. The authority citation for part 72 continues to read as follows:
Authority: Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63,
65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42
U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e,
2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy
Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C.
5841, 5842, 5846, 5851); National Environmental Policy Act of 1982,
secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42
U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g),
10168, 10198(a)); 44 U.S.C. 3504 note.
Section 72.44(g) also issued under Nuclear Waste Policy Act
secs. 142(b) and 148(c), (d) (42 U.S.C. 10162(b), 10168(c), (d)).
Section 72.46 also issued under Atomic Energy Act sec. 189 (42
U.S.C. 2239); Nuclear Waste Policy Act sec. 134 (42 U.S.C. 10154).
Section 72.96(d) also issued under Nuclear Waste Policy Act sec.
145(g) (42 U.S.C. 10165(g)).
Subpart J also issued under Nuclear Waste Policy Act secs.
117(a), 141(h) (42 U.S.C. 10137(a), 10161(h)).
Subpart K also issued under sec. 218(a) (42 U.S.C. 10198).
0
2. In Sec. 72.214, Certificate of Compliance No. 1014 is revised to
read as follows:
Sec. 72.214 List of approved spent fuel storage casks.
* * * * *
Certificate Number: 1014.
Initial Certificate Effective Date: May 31, 2000.
Amendment Number 1 Effective Date: July 15, 2002.
Amendment Number 2 Effective Date: June 7, 2005.
Amendment Number 3 Effective Date: May 29, 2007.
Amendment Number 4 Effective Date: January 8, 2008.
Amendment Number 5 Effective Date: July 14, 2008.
[[Page 378]]
Amendment Number 6 Effective Date: August 17, 2009.
Amendment Number 7 Effective Date: December 28, 2009.
Amendment Number 8 Effective Date: May 2, 2012, as corrected on
November 16, 2012 (ADAMS Accession No. ML12213A170).
Amendment Number 9 Effective Date: March 11, 2014, superseded by
Amendment Number 9, Revision 1, on March 21, 2016.
xxxx
Amendment Number 9, Revision 1, Effective Date: March 21, 2016.
Safety Analysis Report (SAR) Submitted by: Holtec International.
SAR Title: Final Safety Analysis Report for the HI-STORM 100 Cask
System.
Docket Number: 72-1014.
Certificate Expiration Date: May 31, 2020.
Model Number: HI-STORM 100.
* * * * *
Dated at Rockville, Maryland, this 22nd day of December, 2015.
For the Nuclear Regulatory Commission.
Glenn M. Tracy,
Acting, Executive Director for Operations.
[FR Doc. 2015-33280 Filed 1-5-16; 8:45 am]
BILLING CODE 7590-01-P