Notice of Extension of Comment Period for Proposed Generic Communication; NRC Regulatory Issue Summary 2005-02, Revision 1, Clarifying the Process for Making Emergency Plan Changes, 50840-50845 [E9-23683]
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Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices
Dated: September 25, 2009.
James Mazzarella,
Vice President (Acting), Congressional and
Public Affairs, Millennium Challenge
Corporation.
[FR Doc. E9–23652 Filed 9–30–09; 8:45 am]
BILLING CODE 9211–03–P
NATIONAL SCIENCE FOUNDATION
Notice of Permit Modification Request
Received Under the Antarctic
Conservation Act of 1978
National Science Foundation.
Notice of permit modification
request received under the Antarctic
Conservation Act of 1978, Public Law
95–541.
AGENCY:
ACTION:
Notice is hereby given that
the National Science Foundation (NSF)
has received a request to modify a
permit issued to conduct activities
regulated under the Antarctic
Conservation Act of 1978 (Pub. L. 95–
541; Code of Federal Regulations Title
45, Part 670).
DATES: Interested parties are invited to
submit written data, comments, or
views with respect to the permit
modification by November 2, 2009. The
permit modification request may be
inspected by interested parties at the
Permit Office, address below.
ADDRESSES: Comments should be
addressed to Permit Office, Room 755,
Office of Polar Programs, National
Science Foundation, 4201 Wilson
Boulevard, Arlington, Virginia 22230.
FOR FURTHER INFORMATION CONTACT:
Polly A. Penhale or Nadene G. Kennedy
at the above address or (703) 292–8030.
AMLR Program plans to use an
unmanned aerial vehicle (VTOL–UAV)
for conducting census surveys of animal
colonies. Finally the Program wishes up
to release at sea up to 150 XBT’s
(expendable bathythermographs) and 55
drifters per annum to collect
hydrographic data within the study
survey grid to better understand the
relationship between the target species
and their environment.
The duration of the requested
modifications is coincident with the
current permit which expires on April
15, 2011.
Nadene G. Kennedy,
Permit Officer.
[FR Doc. E9–23732 Filed 9–30–09; 8:45 am]
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SUMMARY:
Description of Permit Modification
Requested
On October 26, 2006, the National
Science Foundation issued a waste
management permit (2007 WM–001) to
Rennie S. Holt, Director, Antarctic
Marine Living Resources (AMLR)
Program, Southwest Fisheries Service
after posting a notice in the May 19,
2006 Federal Register. Public comments
were not received. The issued permit
was for the operation and maintenance
of a remote science field camp at Cape
Shirreff. Dr. Rennie Holt has
subsequently retired and a new Director
for the AMLR Program, Dr. George
Watters, is now the permit holder. He
has requested modifications to his waste
permit to cover the use of an all-terrain
vehicle (ATV) and construction of a
small storage facility. The ATV is to
replace the one originally provided by
the Chilean Program to help move
supplies and field cargo. In addition the
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NUCLEAR REGULATORY
COMMISSION
Advisory Committee on Reactor
Safeguards (ACRS); Meeting of the
Subcommittee on Digital
Instrumentation and Control Systems;
Notice of Meeting
The ACRS Subcommittee on Digital
Instrumentation and Control Systems
(DI&C) will hold a meeting on October
23, 2009, Room T2–B3, 11545 Rockville
Pike, Rockville, Maryland.
A portion of this meeting may be
closed to discuss and protect
information classified as National
Security Information as well as
Safeguards Information pursuant to 5
U.S.C. 552b(c)(1) and (3).
The agenda for the subject meeting
shall be as follows:
Friday, October 23, 2009, 8:30 a.m.–
5:30 p.m.
The Subcommittee will hear
presentations by and hold discussions
with representatives of the NRC staff
and the industry regarding Regulatory
Guide 5.71, ‘‘Cyber Security Programs
for Nuclear Facilities,’’ and Cyber
Security Plans. The Subcommittee will
gather information, analyze relevant
issues and facts, and formulate
proposed positions and actions, as
appropriate, for deliberation by the full
Committee.
Members of the public desiring to
provide oral statements and/or written
comments should notify the Designated
Federal Official, Ms. Christina
Antonescu (telephone: 301–415–6792,
e-mail: Christina.Antonescu@nrc.gov)
five days prior to the meeting, if
possible, so that appropriate
arrangements can be made. Thirty-five
hard copies of each presentation or
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handout should be provided to the
Designated Federal Official 30 minutes
before the meeting. In addition, one
electronic copy of each presentation
should be e-mailed to the Designated
Federal Official 1 day before the
meeting. If an electronic copy cannot be
provided within this timeframe,
presenters should provide the
Designated Federal Official with a CD
containing each presentation at least 30
minutes before the meeting. Electronic
recordings will be permitted only
during those portions of the meeting
that are open to the public. Detailed
procedures for the conduct of and
participation in ACRS meetings were
published in the Federal Register on
October 6, 2008, (73 FR 58268–58269).
Further information regarding this
meeting can be obtained by contacting
the Designated Federal Official (DFO)
between 8:45 a.m. and 5:30 p.m. (ET).
Persons planning to attend this meeting
are urged to contact the DFO at least two
working days prior to the meeting to be
advised of any potential changes to the
agenda.
Dated: September 25, 2009.
Cayetano Santos,
Chief, Reactor Safety Branch A, Advisory
Committee on Reactor Safeguards.
[FR Doc. E9–23684 Filed 9–30–09; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2009–0365]
Notice of Extension of Comment
Period for Proposed Generic
Communication; NRC Regulatory Issue
Summary 2005–02, Revision 1,
Clarifying the Process for Making
Emergency Plan Changes
AGENCY: Nuclear Regulatory
Commission.
ACTION: Notice of extension of comment
period.
SUMMARY: The U.S. Nuclear Regulatory
Commission (NRC) published a notice
of opportunity for public comment in
the Federal Register (74 FR 42699) on
August 24, 2009, proposing to issue a
regulatory issue summary (RIS) to
clarify the process for making
emergency plan changes. This FRN
version of the draft Regulatory Issue
Summary (RIS) does not include the
Attachments and Enclosures as
described in the body of the RIS. To
view these attachments and enclosures,
refer to the NRC’s Agencywide
Documents Access and Management
System (ADAMS), document number
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Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices
ML080710029. The NRC’s internal nonconcurrence process ‘‘Draft Management
Directive 10.158, ‘NRC NonConcurrence Process’,’’ has been
invoked by a member of the NRC staff
regarding draft RIS 2005–01, Revision 1.
The non-concurrence and supporting
information is publically available
through ADAMS Accession No.
ML092250622.
DATES: The public comment period ends
on October 8, 2009. This notice
announces a fifteen-day extension of the
public comment period until October
23, 2009. Comments submitted after this
date will be considered if it is practical
to do so, but assurance of consideration
cannot be given except for comments
received on or before this date.
You may submit comments
by any one of the following methods.
Please include Docket ID NRC–2009–
0365 in the subject line of your
comments. Comments submitted in
writing or in electronic form will be
posted on the NRC Web site and on the
Federal rulemaking Web site
Regulations.gov. Because your
comments will not be edited to remove
any identifying or contact information,
the NRC cautions you against including
any information in your submission that
you do not want to be publicly
disclosed.
The NRC requests that any party
soliciting or aggregating comments
received from other persons for
submission to the NRC inform those
persons that the NRC will not edit their
comments to remove any identifying or
contact information, and therefore, they
should not include any information in
their comments that they do not want
publicly disclosed.
Federal Rulemaking Web Site: Go to
https://www.regulations.gov and search
for documents filed under Docket ID
NRC–2009–0365. Address questions
about NRC dockets to Carol Gallagher
301–492–3668; e-mail
Carol.Gallagher@nrc.gov.
Mail comments to: Michael T. Lesar,
Chief, Rulemaking and Directives
Branch (RDB), Division of
Administrative Services, Office of
Administration, Mail Stop: TWB–05–
B01M, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001, or by fax to RDB at (301) 492–
3446.
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ADDRESSES:
FOR FURTHER INFORMATION CONTACT: Don
A. Johnson at 301–415–4040 or by email at don.johnson@nrc.gov.
SUPPLEMENTARY INFORMATION:
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NRC Regulatory Issue Summary 2005–
02, Revision 1; Clarifying the Process
for Making Emergency Plan Changes
Addressees
All holders of licenses for nuclear
power reactors under the provisions of
Title 10 of the Code of Federal
Regulations (10 CFR) Part 50, ‘‘Domestic
Licensing of Production and Utilization
Facilities,’’ including those that have
permanently ceased operations and
have certified that fuel has been
permanently removed from the reactor
vessel.
All holders of licenses for research
and test reactors under Part 50.
All holders of and applicants for
nuclear power plant construction
permits, early site permits and limited
work authorizations under Part 50.
All holders of a combined license for
a nuclear power plant under the
provisions of 10 CFR Part 52, ‘‘Licenses,
Certifications, and Approvals for
Nuclear Power Plants.’’
All holders of licenses for fuel
facilities under the provisions of 10 CFR
Part 40 ‘‘Domestic Licensing of Source
Material’’ required to have an
emergency plan under § 40.31(j)(1)(ii).
All holders of licenses for fuel
facilities under the provisions of 10 CFR
Part 70 ‘‘Domestic Licensing of Special
Nuclear Material’’ required to have an
emergency plan under § 70.22(i)(1)(ii).
All holders of certifications for
gaseous diffusion plants under the
provisions of 10 CFR Part 76
‘‘Certification of Gaseous Diffusion
Plants’’ required to have an emergency
plan under § 76.35(f).
All holders of site-specific licenses for
Independent Spent Fuel Storage
Installations under 10 CFR Part 72
‘‘Licensing Requirements for the
Independent Storage of Spent Nuclear
Fuel and High-Level Radioactive Waste,
and Reactor-Related Greater Than Class
C Waste.’’
Intent
The U.S. Nuclear Regulatory
Commission (NRC) is issuing this
regulatory issue summary (RIS) revision
to inform stakeholders that reactor
emergency plan changes that require
prior NRC approval, in accordance with
10 CFR 50.54(q), will need to be
submitted as license amendment
requests in accordance with 10 CFR
50.90, ‘‘Application for Amendment of
License, Construction Permit, or Early
Site Permit.’’ In addition, this revision
will (1) clarify the meaning of ‘‘decrease
in effectiveness’’, as stated in 10 CFR
50.54(q); (2) clarify the process for
evaluating proposed changes to
emergency plans; (3) provide a method
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for evaluating proposed changes to
emergency plans; (4) provide clarifying
guidance on the appropriate content and
format of applications submitted to the
NRC for approval prior to
implementation; and (5) clarify what
constitutes a report of emergency plan
changes to be submitted to the NRC in
accordance with 10 CFR 50.54(q). This
revision supersedes RIS 2005–02, dated
February 14, 2005, in its entirety due to
the extent of changes.
(1) For non-reactor facilities, the
regulations in 10 CFR 40.35(f), 70.32(i),
and 76.91(o) provide direction to
licensees seeking to revise their
emergency plan. An emergency plan
includes the plan as originally approved
by the NRC and all subsequent changes
made by the licensee with, and without,
prior NRC review and approval under
these regulations. The current practice
for non-reactor facilities concerning
emergency plan changes that require
prior NRC approval is to submit the
changes as a license amendment
request. Current regulatory guidance for
non-reactor emergency plans is
contained within Regulatory Guide 3.67,
‘‘Standard Format and Content for
Emergency Plans for Fuel Cycle and
Materials Facilities.’’ The NRC staff is
working on updating Regulatory Guide
3.67 to include applicable elements of
this RIS for fuel cycle facilities. The
NRC will publish a Federal Register
Notice of the issuance for public
comment and availability of the draft
updated Regulatory Guide.
(2) For Independent Spent Fuel
Storage Installations (ISFSI), the
emergency plan change process should
be followed in accordance with 10 CFR
72.44(f). The information in this RIS
provides useful examples of the type of
evaluations NRC expects ISFSI licensees
to conduct in reviewing changes to their
Part 72 approved emergency plans (refer
to § 72.24(k) and § 72.32) and
determining if the changes may be made
without prior NRC approval as required
by § 72.44(f). The current practice for
non-reactor facilities concerning
emergency plan changes that require
prior NRC approval is to submit the
changes as a license amendment
request. Additional guidance on
emergency planning for ISFSI licensees
is provided in Spent Fuel Storage and
Transportation Interim Staff Guidance–
16, ‘‘Emergency Planning.’’
This RIS revision requires no action
or written response on the part of
addressees.
Background Information
The regulation in 10 CFR 50.54(q)
provides direction to licensees seeking
to revise their emergency plan. The
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requirements related to nuclear power
plant emergency plans are given in the
standards in 10 CFR 50.47, ‘‘Emergency
Plans,’’ and the requirements of
Appendix E, ‘‘Emergency Planning and
Preparedness for Production and
Utilization Facilities’’ to 10 CFR Part 50.
The standards in § 50.54(q) and
Appendix E to Part 50 also establish the
requirements related to emergency plans
for research and test reactors. Based
upon feedback from the nuclear power
industry, the research and test reactor
community, and experience gained by
the NRC staff after reviewing emergency
plan changes, the NRC staff has
identified a need to clarify the process
for making changes to an emergency
plan and to provide licensees with a
consistent method for evaluating
proposed emergency plan changes.
In addition, the NRC staff clarifies
herein that the license amendment
process is the correct process to use
when reviewing decrease (reduction) in
effectiveness submittals. Courts have
found that Commission actions that
expand licensees’ authority under their
licenses without formally amending the
licenses constitute license amendments
and should be processed through the
Commission’s license amendment
procedures. See Citizens Awareness
Network, Inc. v. NRC, 59 F.3d 284 (1st
Cir. 1995); Sholly v. NRC, 651 F.2d 780
(DC Cir. 1980) (per curiam), vacated on
other grounds, 459 U.S. 1194 (1983);
and In re Three Mile Island Alert, 771
F.2d 720, 729 (3rd Cir. 1985), cert.
denied, 475 U.S. 1082 (1986). See also
Cleveland Electric Illuminating Co.
(Perry Nuclear Power Plant, Unit 1),
CLI–96–13, 44 NRC 315 (1996). A
proposed emergency plan change that
would reduce the effectiveness of the
plan would give the licensee a
capability to operate at a level of
effectiveness that was not previously
authorized by the NRC. In this situation,
the licensee’s operating authority would
be expanded beyond the authority
granted by the NRC as reflected in the
emergency plan without the proposed
change. Thus, an emergency plan
change that would reduce the
effectiveness of the plan would expand
the licensee’s operating authority under
its license. A change expanding the
licensee’s operating authority is,
according to the courts, a license
amendment and must be accomplished
through a license amendment process.
The staff also stated in SECY–08–
0024, ‘‘Delegation of Commission
Authority to Staff to Approve or Deny
Emergency Plan Changes that Represent
a Decrease in Effectiveness,’’ dated
February 25, 2008, ‘‘To make the
process by which the NRC will address
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proposed 10 CFR 50.54(q) changes that
represent a decrease in effectiveness
clearer, the staff intends to incorporate
language similar to that which currently
exists in 10 CFR 50.54(p)(1), as part of
the planned rulemaking.’’ The current
schedule for the staff’s emergency
preparedness (EP) rulemaking calls for
the final rule to be issued no earlier than
the summer of 2010. Because of the
timeframe associated with the
rulemaking, the staff has determined
that the prudent action is to issue a RIS
to clarify that licensees must submit
proposed emergency plan changes
which represent a decrease in
effectiveness for NRC approval as
specified in § 50.54(q), and the license
amendment process is the correct
process for the staff to use in reviewing
the proposed change. For purposes of
discussion and to incorporate the
possibility of future regulatory changes,
the term ‘‘decrease in effectiveness’’ is
considered synonymous with
‘‘reduction in effectiveness (RIE).’’
Summary of Issue
Licensees routinely evaluate proposed
revisions to their emergency plan, to
determine if these changes reduce the
effectiveness of their current approved
emergency plan or adversely affect their
ability to implement the emergency
plan. Clarification is needed of an
acceptable method for licensees to use
in consistently evaluating proposed
changes to the emergency plan to ensure
the licensee’s ability to maintain and
implement the approved emergency
plan. Additionally, licensees should
understand the process for submitting
proposed emergency plan changes to the
NRC for approval prior to
implementation when there is a
determination of a decrease (reduction)
in effectiveness.
The change process is described
below and clarified by providing a
screening criterion that would ensure
consistency of emergency plan change
determinations of a decrease (reduction)
in effectiveness. Enclosure 1, ‘‘10 CFR
50.54(q) Evaluation Procedure,’’
presents a suggested outline for
applying the screening criteria for the
evaluation of a proposed emergency
plan change, which is graphically
depicted in Attachment 1 to Enclosure
1, ‘‘10 CFR 50.54(q) Flowchart.’’ In
addition, Enclosure 2, ‘‘Guidance for
Content of Emergency Plan Submittals
to NRC Requiring Prior NRC Approval,’’
provides guidance to licensees in the
development of their application for
NRC prior approval of proposed
emergency plan changes. The
information in this RIS revision clarifies
the process for changing emergency
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plans to ensure that licensees maintain
effective emergency plans thereby
maintaining reasonable assurance that
adequate protective measures can and
will be taken in the event of a
radiological emergency. This RIS
revision also provides a consistent
methodology for licensees to evaluate
changes to their emergency plans and
provides clarifying guidance for the
development of applications for NRC
prior approval. This will help ensure
that NRC review activities and decisions
are effective, efficient, predictable, and
consistent.
The regulations require licensees to
submit a report of each change within
a specified period of time after the
change is made. The NRC Inspectors use
this report to evaluate the effectiveness
of a licensee’s emergency plan change
management program in accordance
with NRC Inspection Procedures, and
although not required, the inclusion of
the applicable licensee evaluation and
justification for the change as part of
this report would be beneficial to the
staff.
Regulation
In part, 10 CFR 50.54(q) states the
following:
The nuclear power reactor licensee
may make changes to these plans
without Commission approval only if
the changes do not decrease the
effectiveness of the plans and the plans,
as changed, continue to meet the
standards of § 50.47(b) and the
requirements of appendix E to this part.
The research reactor and/or the fuel
facility licensee may make changes to
these plans without Commission
approval only if these changes do not
decrease the effectiveness of the plans
and the plans, as changed, continue to
meet the requirements of appendix E to
this part * * *. Proposed changes that
decrease the effectiveness of the
approved emergency plans may not be
implemented without application to and
approval by the Commission.
Definitions
(1) Decrease (Reduction) in
Effectiveness (RIE).
(a) A change in an emergency plan
that results in reducing the licensee’s
capability to perform an emergency
planning function in the event of a
radiological emergency.
(i) Note that other licensee activities
could affect the ability to implement the
emergency plan effectively. Licensees
must maintain the effectiveness of their
NRC approved emergency plans, up to
and including ensuring that changes
made to other programs, structures,
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systems or components do not adversely
impact the licensee’s ability to
effectively implement its emergency
plan. See Information Notice 2005–19,
‘‘Effect of Plant Configuration Changes
on the Emergency Plan,’’ dated July 18,
2005, for additional information.
(1) An RIE will occur if there is a
change or reduction in an emergency
planning function without a
commensurate reduction or change in
the bases for that emergency planning
function or without measures put in
place to reduce the impact of the
proposed change to the emergency plan.
The overall impact of proposed changes
on the effectiveness of the emergency
plan or its implementation is to be
determined, not just the effect that
individual changes have on a specific
part of the emergency plan.
(2) The following provides some
examples of RIEs that would require
prior NRC approval without a
commensurate reduction or change in
the bases for that emergency planning
function or without measures put in
place to reduce the impact of the
proposed change to the emergency plan.
These examples should not be viewed
as being all-inclusive or exclusive;
rather, licensees should use them to
inform decisions involving various
changes being considered. It is also
possible that site-specific situations may
make a particular example inapplicable
to a site. Even if a particular example
completely encompasses the change
being considered, the licensee’s
emergency plan change evaluation
should explain why the site-specific
implementation of the change would
not be an RIE for that particular site. It
is not sufficient for such an analysis to
simply cross-reference an example in
this RIS revision.
(a) A change that would cause any of
the major functional areas or major tasks
identified in the emergency plans to be
unassigned. An example of this would
be a technical specification change
eliminating on-shift radiation technician
coverage without making an alternative
arrangement for providing the requisite
technical expertise in a timely manner.
(b) A change that would impede site
access for offsite assistance relied on in
the plan without viable alternate
arrangements being made. An example
would be the closure or planned closure
of a major river bridge in a case where
the route via the nearest available
crossing would incur a substantial
increase in response time.
(c) A change to the emergency
response organization (ERO) callout
procedures or hardware that would
delay ERO notification such that the
augmentation times in the emergency
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plans can no longer be achieved. A
change to communications hardware
that would reduce the capability to
initiate and complete required
emergency notifications within 15
minutes of the emergency declaration.
(d) A change to the onsite
meteorological measurements program
such that meteorological data currently
readily available in emergency response
facilities in accordance with the
emergency plan would no longer be
readily available.
(e) A change to hazard assessment and
radiation protection assignments in reentry and recovery procedures that
would not provide an adequate level of
personal protection in uncertain reentry
conditions.
(f) A change that reduces the
availability of site familiarization
training currently presented to offsite
assistance groups (e.g., firefighters, local
law enforcement, and medical services,
including mutual aid companies that
would support these groups).
(g) A change that delegates the
responsibility for performance of
various aspects of emergency plan
maintenance to contractors or other
external groups without adequate
supervisory oversight to ensure that
program elements continue to be met
(e.g., a change delegating testing and
maintenance of the Alert and
Notification System to an external group
not subject to typical nuclear facility
work process and configuration
controls).
(3) For proposed changes to
individual emergency action levels
(EALs) (i.e., not an entire EAL scheme
change), an RIE will occur in the
following cases:
(a) The proposed change to the EAL
would potentially cause an
underclassification, (e.g., what was
considered an Alert in the approved
emergency plan would now be
considered an Unusual Event or not
classified at all).
(b) The proposed change to the EAL
would potentially cause an
overclassification, (e.g., what was
considered a Site Area Emergency in the
approved emergency plan would now
be considered a General Emergency
with potential consequences for public
health and safety).
(c) If the proposed change to the EAL
is to change an Initiating Condition
setpoint (or threshold) without a
commensurate change in the regulatory
basis for the EAL Initiating Condition
setpoint (or threshold).
(d) The actual numerical setpoint of a
given EAL may be revised without prior
NRC approval under the following
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conditions via the 10 CFR 50.54(q)
emergency plan change process:
(i) The regulatory basis for the EAL
setpoint has been revised and is
approved via a letter to the licensee or
a Safety Evaluation (SE). For example, a
site receives NRC approval (via a SE) for
power up-rate. Power up-rate
implementation causes the ‘‘normal’’
radiation levels to increase, thus
necessitating an increase in EAL
setpoints based on ‘‘normal’’ radiation
levels. The regulatory basis for the
setpoint has been changed, thus this
change can be processed via the
emergency plan change process because
the effectiveness of the emergency plan
has not been reduced.
(ii) The regulatory basis for the EAL
setpoint has not been changed but the
method for detection of the setpoint has
been changed. For example, a given EAL
setpoint is based upon exceeding 1 Rem
total effective dose equivalent (TEDE).
The radiation monitor reading setpoint
is based upon a reading that would give
the equivalent of exceeding 1 Rem
TEDE. The radiation monitor is replaced
and operates differently. The actual
numerical value of the EAL needs to be
revised to that which is equivalent to 1
Rem TEDE. The regulatory basis for the
setpoint has not been changed, thus this
change can be processed via the
emergency plan change process as the
effectiveness of the emergency plan has
not been reduced.
(2) Emergency plan.
(a) The document(s) prepared and
maintained by the licensee that identify
and describe the licensee’s methods for
maintaining and performing emergency
planning functions. An emergency plan
includes the plans as originally
approved by the NRC and all
subsequent changes made by the
licensee with, and without, prior NRC
review and approval under 10 CFR
50.54(q).
(i) The licensee’s emergency plan
consists of:
(1) The emergency plan as approved
by the NRC via a Safety Evaluation
Report, SE, or license amendment (LA)
from the Office of Nuclear Reactor
Regulation (NRR) or the Office of
Federal and State Materials and
Environmental Management Programs
(FSME).
(2) Changes to the emergency plan
explicitly reviewed by the NRC through
an SE, or LA from NRR or FSME, and
found to meet the applicable
regulations.
(3) Changes to the emergency plan
explicitly reviewed by the NRC through
an SE, or LA, and found to be an
approved amendment to the licensee’s
emergency plan.
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(4) Changes made by the licensee
without NRC review and approval after
the licensee concluded that the
change(s) do not constitute a RIE.
Emergency Plan Change Process
1. Process Overview
Reasonable assurance that adequate
protective measures can and will be
taken in the event of a radiological
emergency is based on the licensee’s
emergency plan, and the successful
implementation of that emergency plan.
The body of an emergency plan contains
statements that describe how a licensee
will meet regulatory requirements. The
standards of 10 CFR 50.47(b) and the
requirements of Appendix E to 10 CFR
Part 50 establish the contents of the
nuclear power reactor emergency plan.
The standards in § 50.54(q) and
Appendix E to Part 50 establish the
requirements related to emergency plans
for research and test reactors.
Subsequent changes to the emergency
plan must comply with § 50.54(q).
Enclosure 1 outlines the emergency plan
change process, and Attachment 1 to
Enclosure 1 graphically depicts the
process in a flowchart.
PWALKER on DSK8KYBLC1PROD with NOTICES
2. Emergency Plan Review
Changes to an emergency plan may
result from advances in technology, new
or revised rules, site-specific needs,
processes, guidance (such as Nuclear
Energy Institute guidance endorsed by
the NRC), technical specification
changes, or modifications to
instrumentation. Changes that the
licensee has identified as RIEs must be
submitted to the NRC for review and
prior approval. The NRC staff will
review the emergency plan change
against the standards, regulations,
guidance documents and the approved
emergency plan. The NRC will review
and approve submittals on a case-bycase basis. An emergency plan change
approved for one licensee does not
mean that the same or similar change
would be approved for another licensee.
For the purposes of determining
whether a change to a licensee’s
emergency plan constitutes an RIE, the
licensee should use the last emergency
plan reviewed and approved by the
NRC. If the emergency plan change
process has been properly implemented
over the years, comparing a proposed
emergency plan change to either the
latest emergency plan reviewed and
approved by the NRC or the emergency
plan as changed by the licensee should
result in the same RIE determination.
For example, if a licensee made a series
of changes over time to the same
specific provision of the emergency
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19:32 Sep 30, 2009
Jkt 217001
plan, where each change was separately
determined not to constitute an RIE,
then there should be no RIE. Therefore,
there should be no RIE when comparing
the latest emergency plan to the
emergency plan reviewed and approved
by the NRC. If a licensee or the NRC
concludes that there is a RIE due to a
series of changes over time, then the
provisions of the emergency plan
change process have not been correctly
followed.
The EP requirements are a framework
for how the licensee will meet the
applicable standards and requirements
of the regulations. If a licensee has
determined that an EP requirement
should be increased in order to meet the
planning standards or Appendix E to
Part 50 requirements, these changes
must follow the emergency plan change
process and revise the emergency plan
to reflect this increase to the EP
requirement. Nevertheless, whether or
not an emergency plan change results in
a RIE is not determined by assessing
whether NRC regulatory requirements
continue to be met after the EP
requirement has been changed. The
licensee’s emergency plan may include
EP requirements that exceed the
baseline standards and requirements as
set forth in § 50.47(b) and Appendix E
to Part 50. For the RIE determination,
the change or changes should be
evaluated against the capability to
perform the functions and the
associated time requirement of
performing the function, if applicable.
The evaluation should document
whether the capability or timeliness to
perform a function is lost and/or
degraded. In addition to the RIE
determination, the change or changes
should also be evaluated to verify that
they continue to meet the standards and
requirements as set forth in § 50.47(b)
and Appendix E to Part 50.
The current Commission
requirements for document retention in
§ 50.54(q), specify that changes that do
not warrant NRC approval must be
retained for 3 years. The licensee must
retain changes that reduce the
effectiveness of the emergency plan
until the Commission terminates the
license. It may be prudent to save
emergency plan change documentation
to show the historical progression of
changes, since the Commission, through
its staff, may review at any time, the
emergency plan changes that have been
made.
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
Related Topics Regarding Emergency
Plan Changes
1. Regulatory Process for Evaluating
Licensee Requests for NRC Prior
Approval of Emergency Plan Changes
Determined To Be a RIE in Accordance
With 10 CFR 50.54(q)
Similar to security plan changes
submitted via 10 CFR 50.54(p)(1),
emergency plan changes that result in
the reduction in the effectiveness of the
approved emergency plan require prior
NRC approval, under § 50.54(q), and
should be submitted as license
amendment requests under § 50.90.
2. Emergency Action Level Changes
A revision to an entire EAL scheme,
from NUREG–0654, ‘‘Criteria for
Preparation and Evaluation of
Radiological Emergency Response Plans
and Preparedness in Support of Nuclear
Power Plants,’’ to another NRCendorsed EAL scheme, must be
submitted for prior NRC approval as
specified in Section IV.B. of Appendix
E to 10 CFR Part 50. The Statement of
Considerations for the final rule
amending the NRC’s regulations relating
to NRC approval of EAL changes, dated
January 26, 2005, stated in part, ‘‘The
Commission believes a licensee’s
proposal to convert from one EAL
scheme (e.g., NUREG–0654-based) to
another EAL Scheme (NUMARC/NESP–
007 or NEI 99–01 based) * * * is of
sufficient significance to require prior
NRC review and approval. NRC review
and approval for such major changes in
EAL methodology is necessary to ensure
that there is reasonable assurance that
the final EAL change will provide an
acceptable level of safety.’’ Regulatory
Guide 1.101, Revisions 3 and 4,
‘‘Emergency Planning and Preparedness
for Nuclear Power Reactor,’’ endorsed
NUMARC/NESP–007 and NEI 99–01
EAL guidance, respectively, as
acceptable alternatives to the guidance
provided in NUREG–0654 for
development of EALs to comply with
§ 50.47 and Appendix E to Part 50. A
change in an EAL scheme to incorporate
the improvements provided in
NUMARC/NESP–007 or NEI 99–01
would not decrease the overall
effectiveness of the emergency plan and
would not expand a licensee’s operating
authority beyond that previously
authorized by NRC, but due to the
potential safety significance of the
change, the change needs prior NRC
review and approval. This approval is
given via SE and letter.
Revisions of an individual EAL that
results in a decrease in effectiveness
must be submitted for NRC approval as
specified in § 50.54(q), and the license
E:\FR\FM\01OCN1.SGM
01OCN1
Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices
amendment process is the correct
process for the staff to use in reviewing
the proposed change. As discussed
previously, an emergency plan change
that would reduce the effectiveness of
the plan would expand the licensee’s
operating authority under its license. A
change expanding the licensee’s
authority is, according to the courts, a
license amendment and must be
accomplished through a license
amendment process. For research and
test reactors, NUREG–0849, ‘‘Standard
Review Plan for the Review and
Evaluation of Emergency Plans for
Research and Test Reactors,’’ issued
October 1983, provides guidance on
EALs and how changes should be made
on a case-by-case basis with
consideration of the provisions of
§ 50.54(q).
PWALKER on DSK8KYBLC1PROD with NOTICES
3. Inspection Activities
For power reactors, the NRC
inspectors use Inspection Procedure (IP)
71114.04 to conduct a review of the
effectiveness of the licensee’s
implementation of the 10 CFR 50.54(q)
change process. For research and test
reactors, the NRC inspectors use IP
69011, ‘‘Class I Research and Test
Reactor Emergency Preparedness,’’ and
IP 69001, ‘‘Class II Research and Test
Reactors.’’ The inspector will perform a
screening review of the change relative
to the emergency plan; however, this
will not constitute NRC approval of the
plan as changed.
The documentation of the change
reviewed by the inspectors will be the
report provided by the licensee as stated
in § 50.54(q). Although not required, the
inclusion of the applicable licensee
evaluation and justification for the
change as part of this report would
assist the staff in the review.
4. Lower Tier Documents
If a licensee has incorporated a lower
tier document into the emergency plan
or the emergency plan explicitly
references a lower tier document as a
method to implement a specific
requirement in the emergency plan,
then, it is considered part of the plan
and subject to § 50.54(q) review.
Historically, some licensees have
developed emergency plan
implementing procedures that included
the necessary information needed for
activities that are required to meet the
regulations, for example, procedures for
notifications, dose assessment,
protective action recommendations,
emergency classifications and
emergency action levels. The staff is not
making the use of § 50.54(q) to review
all changes to lower tier documents a
requirement, but acknowledges that
VerDate Nov<24>2008
19:32 Sep 30, 2009
Jkt 217001
using § 50.54(q) as the regulation to
provide revision control of these lower
tier documents has been in place and
supported by the NRC through the
inspection and licensing process.
Backfit Discussion
This RIS revision does not require any
action or written response. This RIS
revision provides non-regulatory review
guidance for licensees and clarifies
existing regulatory requirements
licensees must follow when proposing
changes to their emergency plans. The
NRC’s Backfit Rule, 10 CFR 50.109,
applies to, among other things, the
procedures necessary to operate a
nuclear power plant. To the extent that
using a license amendment process for
making modifications to emergency
plans that reduce the effectiveness of
the plans is considered a change, it
would be a change to the NRC’s
regulatory process for addressing
modifications to the emergency plan.
The NRC’s regulatory review process is
not a licensee procedure required for
operating a plant that would be subject
to backfit limitations.
Further, the Backfit Rule protects
licensees from Commission actions that
arbitrarily change license terms and
conditions. In 10 CFR 50.54(q), a
licensee requests Commission authority
to do what is not currently permitted
under its license. The licensee has no
valid expectations protected by the
Backfit Rule regarding the means for
obtaining the new authority that is not
permitted under the current license. For
these reasons, this RIS revision does not
constitute a backfit under 10 CFR
50.109, and the staff did not perform a
backfit analysis.
Federal Register Notification
To be done after the public comments
periods.
Paperwork Reduction Act Statement
This RIS revision does not contain
information collections and, therefore,
is not subject to the requirements of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Public Protection Notification
The NRC may not conduct or sponsor,
and a person is not required to respond
to, a request for information or an
information collection requirement
unless the requesting document
displays a currently valid Office of
Management and Budget control
number.
Contact
Please direct any questions about this
matter to Don A. Johnson at (301) 415–
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
50845
4040, or by e-mail:
don.johnson@nrc.gov.
End of Draft Regulatory Issue Summary
Documents may be examined, and/or
copied for a fee, at the NRC’s Public
Document Room at One White Flint
North, 11555 Rockville Pike (first floor),
Rockville, Maryland. Publicly available
records will be accessible electronically
from the Agencywide Documents
Access and Management System
(ADAMS) Public Electronic Reading
Room on the Internet at the NRC Web
site, https://www.nrc.gov/NRC/ADAMS/
index.html. If you do not have access to
ADAMS or if you have problems in
accessing the documents in ADAMS,
contact the NRC Public Document Room
(PDR) reference staff at 1–800–397–4209
or 301–415–4737 or by e-mail to
pdr@nrc.gov.
Dated at Rockville, Maryland, this 24th day
of September 2009.
For the Nuclear Regulatory Commission.
Martin C. Murphy,
Chief, Generic Communications Branch,
Division of Policy and Rulemaking, Office
of Nuclear Reactor Regulation.
[FR Doc. E9–23683 Filed 9–30–09; 8:45 am]
BILLING CODE 7590–01–P
OFFICE OF PERSONNEL
MANAGEMENT
Notice of Federal Long Term Care
Insurance Program Special Decision
Period for Current Enrollees
AGENCY: U.S. Office of Personnel
Management.
ACTION: Notice of Federal Long Term
Care Insurance Program special decision
period for current enrollees.
SUMMARY: The U.S. Office of Personnel
Management (OPM) is announcing rules
for current enrollees in the Federal Long
Term Care Insurance Program (FLTCIP)
who will be eligible to change coverage
during a limited Special Decision Period
to be held this year. These rules pertain
only to current eligible enrollees who
may make changes because of new plan
features and premium rate increases for
some enrollees. Eligible enrollees in the
standard plan as of October 1, 2009, and
those individuals whose application for
the standard plan was received on or
before September 30, 2009, and whose
enrollment was approved may make
changes during the Special Decision
Period, provided they are not in benefit
eligible status.
DATES: The Special Decision Period will
be from October 1 through December 14,
2009.
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 74, Number 189 (Thursday, October 1, 2009)]
[Notices]
[Pages 50840-50845]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23683]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2009-0365]
Notice of Extension of Comment Period for Proposed Generic
Communication; NRC Regulatory Issue Summary 2005-02, Revision 1,
Clarifying the Process for Making Emergency Plan Changes
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) published a
notice of opportunity for public comment in the Federal Register (74 FR
42699) on August 24, 2009, proposing to issue a regulatory issue
summary (RIS) to clarify the process for making emergency plan changes.
This FRN version of the draft Regulatory Issue Summary (RIS) does not
include the Attachments and Enclosures as described in the body of the
RIS. To view these attachments and enclosures, refer to the NRC's
Agencywide Documents Access and Management System (ADAMS), document
number
[[Page 50841]]
ML080710029. The NRC's internal non-concurrence process ``Draft
Management Directive 10.158, `NRC Non-Concurrence Process','' has been
invoked by a member of the NRC staff regarding draft RIS 2005-01,
Revision 1. The non-concurrence and supporting information is
publically available through ADAMS Accession No. ML092250622.
DATES: The public comment period ends on October 8, 2009. This notice
announces a fifteen-day extension of the public comment period until
October 23, 2009. Comments submitted after this date will be considered
if it is practical to do so, but assurance of consideration cannot be
given except for comments received on or before this date.
ADDRESSES: You may submit comments by any one of the following methods.
Please include Docket ID NRC-2009-0365 in the subject line of your
comments. Comments submitted in writing or in electronic form will be
posted on the NRC Web site and on the Federal rulemaking Web site
Regulations.gov. Because your comments will not be edited to remove any
identifying or contact information, the NRC cautions you against
including any information in your submission that you do not want to be
publicly disclosed.
The NRC requests that any party soliciting or aggregating comments
received from other persons for submission to the NRC inform those
persons that the NRC will not edit their comments to remove any
identifying or contact information, and therefore, they should not
include any information in their comments that they do not want
publicly disclosed.
Federal Rulemaking Web Site: Go to https://www.regulations.gov and
search for documents filed under Docket ID NRC-2009-0365. Address
questions about NRC dockets to Carol Gallagher 301-492-3668; e-mail
Carol.Gallagher@nrc.gov.
Mail comments to: Michael T. Lesar, Chief, Rulemaking and
Directives Branch (RDB), Division of Administrative Services, Office of
Administration, Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, or by fax to RDB at (301) 492-
3446.
FOR FURTHER INFORMATION CONTACT: Don A. Johnson at 301-415-4040 or by
e-mail at don.johnson@nrc.gov.
SUPPLEMENTARY INFORMATION:
NRC Regulatory Issue Summary 2005-02, Revision 1; Clarifying the
Process for Making Emergency Plan Changes
Addressees
All holders of licenses for nuclear power reactors under the
provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part
50, ``Domestic Licensing of Production and Utilization Facilities,''
including those that have permanently ceased operations and have
certified that fuel has been permanently removed from the reactor
vessel.
All holders of licenses for research and test reactors under Part
50.
All holders of and applicants for nuclear power plant construction
permits, early site permits and limited work authorizations under Part
50.
All holders of a combined license for a nuclear power plant under
the provisions of 10 CFR Part 52, ``Licenses, Certifications, and
Approvals for Nuclear Power Plants.''
All holders of licenses for fuel facilities under the provisions of
10 CFR Part 40 ``Domestic Licensing of Source Material'' required to
have an emergency plan under Sec. 40.31(j)(1)(ii).
All holders of licenses for fuel facilities under the provisions of
10 CFR Part 70 ``Domestic Licensing of Special Nuclear Material''
required to have an emergency plan under Sec. 70.22(i)(1)(ii).
All holders of certifications for gaseous diffusion plants under
the provisions of 10 CFR Part 76 ``Certification of Gaseous Diffusion
Plants'' required to have an emergency plan under Sec. 76.35(f).
All holders of site-specific licenses for Independent Spent Fuel
Storage Installations under 10 CFR Part 72 ``Licensing Requirements for
the Independent Storage of Spent Nuclear Fuel and High-Level
Radioactive Waste, and Reactor-Related Greater Than Class C Waste.''
Intent
The U.S. Nuclear Regulatory Commission (NRC) is issuing this
regulatory issue summary (RIS) revision to inform stakeholders that
reactor emergency plan changes that require prior NRC approval, in
accordance with 10 CFR 50.54(q), will need to be submitted as license
amendment requests in accordance with 10 CFR 50.90, ``Application for
Amendment of License, Construction Permit, or Early Site Permit.'' In
addition, this revision will (1) clarify the meaning of ``decrease in
effectiveness'', as stated in 10 CFR 50.54(q); (2) clarify the process
for evaluating proposed changes to emergency plans; (3) provide a
method for evaluating proposed changes to emergency plans; (4) provide
clarifying guidance on the appropriate content and format of
applications submitted to the NRC for approval prior to implementation;
and (5) clarify what constitutes a report of emergency plan changes to
be submitted to the NRC in accordance with 10 CFR 50.54(q). This
revision supersedes RIS 2005-02, dated February 14, 2005, in its
entirety due to the extent of changes.
(1) For non-reactor facilities, the regulations in 10 CFR 40.35(f),
70.32(i), and 76.91(o) provide direction to licensees seeking to revise
their emergency plan. An emergency plan includes the plan as originally
approved by the NRC and all subsequent changes made by the licensee
with, and without, prior NRC review and approval under these
regulations. The current practice for non-reactor facilities concerning
emergency plan changes that require prior NRC approval is to submit the
changes as a license amendment request. Current regulatory guidance for
non-reactor emergency plans is contained within Regulatory Guide 3.67,
``Standard Format and Content for Emergency Plans for Fuel Cycle and
Materials Facilities.'' The NRC staff is working on updating Regulatory
Guide 3.67 to include applicable elements of this RIS for fuel cycle
facilities. The NRC will publish a Federal Register Notice of the
issuance for public comment and availability of the draft updated
Regulatory Guide.
(2) For Independent Spent Fuel Storage Installations (ISFSI), the
emergency plan change process should be followed in accordance with 10
CFR 72.44(f). The information in this RIS provides useful examples of
the type of evaluations NRC expects ISFSI licensees to conduct in
reviewing changes to their Part 72 approved emergency plans (refer to
Sec. 72.24(k) and Sec. 72.32) and determining if the changes may be
made without prior NRC approval as required by Sec. 72.44(f). The
current practice for non-reactor facilities concerning emergency plan
changes that require prior NRC approval is to submit the changes as a
license amendment request. Additional guidance on emergency planning
for ISFSI licensees is provided in Spent Fuel Storage and
Transportation Interim Staff Guidance-16, ``Emergency Planning.''
This RIS revision requires no action or written response on the
part of addressees.
Background Information
The regulation in 10 CFR 50.54(q) provides direction to licensees
seeking to revise their emergency plan. The
[[Page 50842]]
requirements related to nuclear power plant emergency plans are given
in the standards in 10 CFR 50.47, ``Emergency Plans,'' and the
requirements of Appendix E, ``Emergency Planning and Preparedness for
Production and Utilization Facilities'' to 10 CFR Part 50. The
standards in Sec. 50.54(q) and Appendix E to Part 50 also establish
the requirements related to emergency plans for research and test
reactors. Based upon feedback from the nuclear power industry, the
research and test reactor community, and experience gained by the NRC
staff after reviewing emergency plan changes, the NRC staff has
identified a need to clarify the process for making changes to an
emergency plan and to provide licensees with a consistent method for
evaluating proposed emergency plan changes.
In addition, the NRC staff clarifies herein that the license
amendment process is the correct process to use when reviewing decrease
(reduction) in effectiveness submittals. Courts have found that
Commission actions that expand licensees' authority under their
licenses without formally amending the licenses constitute license
amendments and should be processed through the Commission's license
amendment procedures. See Citizens Awareness Network, Inc. v. NRC, 59
F.3d 284 (1st Cir. 1995); Sholly v. NRC, 651 F.2d 780 (DC Cir. 1980)
(per curiam), vacated on other grounds, 459 U.S. 1194 (1983); and In re
Three Mile Island Alert, 771 F.2d 720, 729 (3rd Cir. 1985), cert.
denied, 475 U.S. 1082 (1986). See also Cleveland Electric Illuminating
Co. (Perry Nuclear Power Plant, Unit 1), CLI-96-13, 44 NRC 315 (1996).
A proposed emergency plan change that would reduce the effectiveness of
the plan would give the licensee a capability to operate at a level of
effectiveness that was not previously authorized by the NRC. In this
situation, the licensee's operating authority would be expanded beyond
the authority granted by the NRC as reflected in the emergency plan
without the proposed change. Thus, an emergency plan change that would
reduce the effectiveness of the plan would expand the licensee's
operating authority under its license. A change expanding the
licensee's operating authority is, according to the courts, a license
amendment and must be accomplished through a license amendment process.
The staff also stated in SECY-08-0024, ``Delegation of Commission
Authority to Staff to Approve or Deny Emergency Plan Changes that
Represent a Decrease in Effectiveness,'' dated February 25, 2008, ``To
make the process by which the NRC will address proposed 10 CFR 50.54(q)
changes that represent a decrease in effectiveness clearer, the staff
intends to incorporate language similar to that which currently exists
in 10 CFR 50.54(p)(1), as part of the planned rulemaking.'' The current
schedule for the staff's emergency preparedness (EP) rulemaking calls
for the final rule to be issued no earlier than the summer of 2010.
Because of the timeframe associated with the rulemaking, the staff has
determined that the prudent action is to issue a RIS to clarify that
licensees must submit proposed emergency plan changes which represent a
decrease in effectiveness for NRC approval as specified in Sec.
50.54(q), and the license amendment process is the correct process for
the staff to use in reviewing the proposed change. For purposes of
discussion and to incorporate the possibility of future regulatory
changes, the term ``decrease in effectiveness'' is considered
synonymous with ``reduction in effectiveness (RIE).''
Summary of Issue
Licensees routinely evaluate proposed revisions to their emergency
plan, to determine if these changes reduce the effectiveness of their
current approved emergency plan or adversely affect their ability to
implement the emergency plan. Clarification is needed of an acceptable
method for licensees to use in consistently evaluating proposed changes
to the emergency plan to ensure the licensee's ability to maintain and
implement the approved emergency plan. Additionally, licensees should
understand the process for submitting proposed emergency plan changes
to the NRC for approval prior to implementation when there is a
determination of a decrease (reduction) in effectiveness.
The change process is described below and clarified by providing a
screening criterion that would ensure consistency of emergency plan
change determinations of a decrease (reduction) in effectiveness.
Enclosure 1, ``10 CFR 50.54(q) Evaluation Procedure,'' presents a
suggested outline for applying the screening criteria for the
evaluation of a proposed emergency plan change, which is graphically
depicted in Attachment 1 to Enclosure 1, ``10 CFR 50.54(q) Flowchart.''
In addition, Enclosure 2, ``Guidance for Content of Emergency Plan
Submittals to NRC Requiring Prior NRC Approval,'' provides guidance to
licensees in the development of their application for NRC prior
approval of proposed emergency plan changes. The information in this
RIS revision clarifies the process for changing emergency plans to
ensure that licensees maintain effective emergency plans thereby
maintaining reasonable assurance that adequate protective measures can
and will be taken in the event of a radiological emergency. This RIS
revision also provides a consistent methodology for licensees to
evaluate changes to their emergency plans and provides clarifying
guidance for the development of applications for NRC prior approval.
This will help ensure that NRC review activities and decisions are
effective, efficient, predictable, and consistent.
The regulations require licensees to submit a report of each change
within a specified period of time after the change is made. The NRC
Inspectors use this report to evaluate the effectiveness of a
licensee's emergency plan change management program in accordance with
NRC Inspection Procedures, and although not required, the inclusion of
the applicable licensee evaluation and justification for the change as
part of this report would be beneficial to the staff.
Regulation
In part, 10 CFR 50.54(q) states the following:
The nuclear power reactor licensee may make changes to these plans
without Commission approval only if the changes do not decrease the
effectiveness of the plans and the plans, as changed, continue to meet
the standards of Sec. 50.47(b) and the requirements of appendix E to
this part. The research reactor and/or the fuel facility licensee may
make changes to these plans without Commission approval only if these
changes do not decrease the effectiveness of the plans and the plans,
as changed, continue to meet the requirements of appendix E to this
part * * *. Proposed changes that decrease the effectiveness of the
approved emergency plans may not be implemented without application to
and approval by the Commission.
Definitions
(1) Decrease (Reduction) in Effectiveness (RIE).
(a) A change in an emergency plan that results in reducing the
licensee's capability to perform an emergency planning function in the
event of a radiological emergency.
(i) Note that other licensee activities could affect the ability to
implement the emergency plan effectively. Licensees must maintain the
effectiveness of their NRC approved emergency plans, up to and
including ensuring that changes made to other programs, structures,
[[Page 50843]]
systems or components do not adversely impact the licensee's ability to
effectively implement its emergency plan. See Information Notice 2005-
19, ``Effect of Plant Configuration Changes on the Emergency Plan,''
dated July 18, 2005, for additional information.
(1) An RIE will occur if there is a change or reduction in an
emergency planning function without a commensurate reduction or change
in the bases for that emergency planning function or without measures
put in place to reduce the impact of the proposed change to the
emergency plan. The overall impact of proposed changes on the
effectiveness of the emergency plan or its implementation is to be
determined, not just the effect that individual changes have on a
specific part of the emergency plan.
(2) The following provides some examples of RIEs that would require
prior NRC approval without a commensurate reduction or change in the
bases for that emergency planning function or without measures put in
place to reduce the impact of the proposed change to the emergency
plan. These examples should not be viewed as being all-inclusive or
exclusive; rather, licensees should use them to inform decisions
involving various changes being considered. It is also possible that
site-specific situations may make a particular example inapplicable to
a site. Even if a particular example completely encompasses the change
being considered, the licensee's emergency plan change evaluation
should explain why the site-specific implementation of the change would
not be an RIE for that particular site. It is not sufficient for such
an analysis to simply cross-reference an example in this RIS revision.
(a) A change that would cause any of the major functional areas or
major tasks identified in the emergency plans to be unassigned. An
example of this would be a technical specification change eliminating
on-shift radiation technician coverage without making an alternative
arrangement for providing the requisite technical expertise in a timely
manner.
(b) A change that would impede site access for offsite assistance
relied on in the plan without viable alternate arrangements being made.
An example would be the closure or planned closure of a major river
bridge in a case where the route via the nearest available crossing
would incur a substantial increase in response time.
(c) A change to the emergency response organization (ERO) callout
procedures or hardware that would delay ERO notification such that the
augmentation times in the emergency plans can no longer be achieved. A
change to communications hardware that would reduce the capability to
initiate and complete required emergency notifications within 15
minutes of the emergency declaration.
(d) A change to the onsite meteorological measurements program such
that meteorological data currently readily available in emergency
response facilities in accordance with the emergency plan would no
longer be readily available.
(e) A change to hazard assessment and radiation protection
assignments in re-entry and recovery procedures that would not provide
an adequate level of personal protection in uncertain reentry
conditions.
(f) A change that reduces the availability of site familiarization
training currently presented to offsite assistance groups (e.g.,
firefighters, local law enforcement, and medical services, including
mutual aid companies that would support these groups).
(g) A change that delegates the responsibility for performance of
various aspects of emergency plan maintenance to contractors or other
external groups without adequate supervisory oversight to ensure that
program elements continue to be met (e.g., a change delegating testing
and maintenance of the Alert and Notification System to an external
group not subject to typical nuclear facility work process and
configuration controls).
(3) For proposed changes to individual emergency action levels
(EALs) (i.e., not an entire EAL scheme change), an RIE will occur in
the following cases:
(a) The proposed change to the EAL would potentially cause an
underclassification, (e.g., what was considered an Alert in the
approved emergency plan would now be considered an Unusual Event or not
classified at all).
(b) The proposed change to the EAL would potentially cause an
overclassification, (e.g., what was considered a Site Area Emergency in
the approved emergency plan would now be considered a General Emergency
with potential consequences for public health and safety).
(c) If the proposed change to the EAL is to change an Initiating
Condition setpoint (or threshold) without a commensurate change in the
regulatory basis for the EAL Initiating Condition setpoint (or
threshold).
(d) The actual numerical setpoint of a given EAL may be revised
without prior NRC approval under the following conditions via the 10
CFR 50.54(q) emergency plan change process:
(i) The regulatory basis for the EAL setpoint has been revised and
is approved via a letter to the licensee or a Safety Evaluation (SE).
For example, a site receives NRC approval (via a SE) for power up-rate.
Power up-rate implementation causes the ``normal'' radiation levels to
increase, thus necessitating an increase in EAL setpoints based on
``normal'' radiation levels. The regulatory basis for the setpoint has
been changed, thus this change can be processed via the emergency plan
change process because the effectiveness of the emergency plan has not
been reduced.
(ii) The regulatory basis for the EAL setpoint has not been changed
but the method for detection of the setpoint has been changed. For
example, a given EAL setpoint is based upon exceeding 1 Rem total
effective dose equivalent (TEDE). The radiation monitor reading
setpoint is based upon a reading that would give the equivalent of
exceeding 1 Rem TEDE. The radiation monitor is replaced and operates
differently. The actual numerical value of the EAL needs to be revised
to that which is equivalent to 1 Rem TEDE. The regulatory basis for the
setpoint has not been changed, thus this change can be processed via
the emergency plan change process as the effectiveness of the emergency
plan has not been reduced.
(2) Emergency plan.
(a) The document(s) prepared and maintained by the licensee that
identify and describe the licensee's methods for maintaining and
performing emergency planning functions. An emergency plan includes the
plans as originally approved by the NRC and all subsequent changes made
by the licensee with, and without, prior NRC review and approval under
10 CFR 50.54(q).
(i) The licensee's emergency plan consists of:
(1) The emergency plan as approved by the NRC via a Safety
Evaluation Report, SE, or license amendment (LA) from the Office of
Nuclear Reactor Regulation (NRR) or the Office of Federal and State
Materials and Environmental Management Programs (FSME).
(2) Changes to the emergency plan explicitly reviewed by the NRC
through an SE, or LA from NRR or FSME, and found to meet the applicable
regulations.
(3) Changes to the emergency plan explicitly reviewed by the NRC
through an SE, or LA, and found to be an approved amendment to the
licensee's emergency plan.
[[Page 50844]]
(4) Changes made by the licensee without NRC review and approval
after the licensee concluded that the change(s) do not constitute a
RIE.
Emergency Plan Change Process
1. Process Overview
Reasonable assurance that adequate protective measures can and will
be taken in the event of a radiological emergency is based on the
licensee's emergency plan, and the successful implementation of that
emergency plan. The body of an emergency plan contains statements that
describe how a licensee will meet regulatory requirements. The
standards of 10 CFR 50.47(b) and the requirements of Appendix E to 10
CFR Part 50 establish the contents of the nuclear power reactor
emergency plan. The standards in Sec. 50.54(q) and Appendix E to Part
50 establish the requirements related to emergency plans for research
and test reactors. Subsequent changes to the emergency plan must comply
with Sec. 50.54(q). Enclosure 1 outlines the emergency plan change
process, and Attachment 1 to Enclosure 1 graphically depicts the
process in a flowchart.
2. Emergency Plan Review
Changes to an emergency plan may result from advances in
technology, new or revised rules, site-specific needs, processes,
guidance (such as Nuclear Energy Institute guidance endorsed by the
NRC), technical specification changes, or modifications to
instrumentation. Changes that the licensee has identified as RIEs must
be submitted to the NRC for review and prior approval. The NRC staff
will review the emergency plan change against the standards,
regulations, guidance documents and the approved emergency plan. The
NRC will review and approve submittals on a case-by-case basis. An
emergency plan change approved for one licensee does not mean that the
same or similar change would be approved for another licensee.
For the purposes of determining whether a change to a licensee's
emergency plan constitutes an RIE, the licensee should use the last
emergency plan reviewed and approved by the NRC. If the emergency plan
change process has been properly implemented over the years, comparing
a proposed emergency plan change to either the latest emergency plan
reviewed and approved by the NRC or the emergency plan as changed by
the licensee should result in the same RIE determination. For example,
if a licensee made a series of changes over time to the same specific
provision of the emergency plan, where each change was separately
determined not to constitute an RIE, then there should be no RIE.
Therefore, there should be no RIE when comparing the latest emergency
plan to the emergency plan reviewed and approved by the NRC. If a
licensee or the NRC concludes that there is a RIE due to a series of
changes over time, then the provisions of the emergency plan change
process have not been correctly followed.
The EP requirements are a framework for how the licensee will meet
the applicable standards and requirements of the regulations. If a
licensee has determined that an EP requirement should be increased in
order to meet the planning standards or Appendix E to Part 50
requirements, these changes must follow the emergency plan change
process and revise the emergency plan to reflect this increase to the
EP requirement. Nevertheless, whether or not an emergency plan change
results in a RIE is not determined by assessing whether NRC regulatory
requirements continue to be met after the EP requirement has been
changed. The licensee's emergency plan may include EP requirements that
exceed the baseline standards and requirements as set forth in Sec.
50.47(b) and Appendix E to Part 50. For the RIE determination, the
change or changes should be evaluated against the capability to perform
the functions and the associated time requirement of performing the
function, if applicable. The evaluation should document whether the
capability or timeliness to perform a function is lost and/or degraded.
In addition to the RIE determination, the change or changes should also
be evaluated to verify that they continue to meet the standards and
requirements as set forth in Sec. 50.47(b) and Appendix E to Part 50.
The current Commission requirements for document retention in Sec.
50.54(q), specify that changes that do not warrant NRC approval must be
retained for 3 years. The licensee must retain changes that reduce the
effectiveness of the emergency plan until the Commission terminates the
license. It may be prudent to save emergency plan change documentation
to show the historical progression of changes, since the Commission,
through its staff, may review at any time, the emergency plan changes
that have been made.
Related Topics Regarding Emergency Plan Changes
1. Regulatory Process for Evaluating Licensee Requests for NRC Prior
Approval of Emergency Plan Changes Determined To Be a RIE in Accordance
With 10 CFR 50.54(q)
Similar to security plan changes submitted via 10 CFR 50.54(p)(1),
emergency plan changes that result in the reduction in the
effectiveness of the approved emergency plan require prior NRC
approval, under Sec. 50.54(q), and should be submitted as license
amendment requests under Sec. 50.90.
2. Emergency Action Level Changes
A revision to an entire EAL scheme, from NUREG-0654, ``Criteria for
Preparation and Evaluation of Radiological Emergency Response Plans and
Preparedness in Support of Nuclear Power Plants,'' to another NRC-
endorsed EAL scheme, must be submitted for prior NRC approval as
specified in Section IV.B. of Appendix E to 10 CFR Part 50. The
Statement of Considerations for the final rule amending the NRC's
regulations relating to NRC approval of EAL changes, dated January 26,
2005, stated in part, ``The Commission believes a licensee's proposal
to convert from one EAL scheme (e.g., NUREG-0654-based) to another EAL
Scheme (NUMARC/NESP-007 or NEI 99-01 based) * * * is of sufficient
significance to require prior NRC review and approval. NRC review and
approval for such major changes in EAL methodology is necessary to
ensure that there is reasonable assurance that the final EAL change
will provide an acceptable level of safety.'' Regulatory Guide 1.101,
Revisions 3 and 4, ``Emergency Planning and Preparedness for Nuclear
Power Reactor,'' endorsed NUMARC/NESP-007 and NEI 99-01 EAL guidance,
respectively, as acceptable alternatives to the guidance provided in
NUREG-0654 for development of EALs to comply with Sec. 50.47 and
Appendix E to Part 50. A change in an EAL scheme to incorporate the
improvements provided in NUMARC/NESP-007 or NEI 99-01 would not
decrease the overall effectiveness of the emergency plan and would not
expand a licensee's operating authority beyond that previously
authorized by NRC, but due to the potential safety significance of the
change, the change needs prior NRC review and approval. This approval
is given via SE and letter.
Revisions of an individual EAL that results in a decrease in
effectiveness must be submitted for NRC approval as specified in Sec.
50.54(q), and the license
[[Page 50845]]
amendment process is the correct process for the staff to use in
reviewing the proposed change. As discussed previously, an emergency
plan change that would reduce the effectiveness of the plan would
expand the licensee's operating authority under its license. A change
expanding the licensee's authority is, according to the courts, a
license amendment and must be accomplished through a license amendment
process. For research and test reactors, NUREG-0849, ``Standard Review
Plan for the Review and Evaluation of Emergency Plans for Research and
Test Reactors,'' issued October 1983, provides guidance on EALs and how
changes should be made on a case-by-case basis with consideration of
the provisions of Sec. 50.54(q).
3. Inspection Activities
For power reactors, the NRC inspectors use Inspection Procedure
(IP) 71114.04 to conduct a review of the effectiveness of the
licensee's implementation of the 10 CFR 50.54(q) change process. For
research and test reactors, the NRC inspectors use IP 69011, ``Class I
Research and Test Reactor Emergency Preparedness,'' and IP 69001,
``Class II Research and Test Reactors.'' The inspector will perform a
screening review of the change relative to the emergency plan; however,
this will not constitute NRC approval of the plan as changed.
The documentation of the change reviewed by the inspectors will be
the report provided by the licensee as stated in Sec. 50.54(q).
Although not required, the inclusion of the applicable licensee
evaluation and justification for the change as part of this report
would assist the staff in the review.
4. Lower Tier Documents
If a licensee has incorporated a lower tier document into the
emergency plan or the emergency plan explicitly references a lower tier
document as a method to implement a specific requirement in the
emergency plan, then, it is considered part of the plan and subject to
Sec. 50.54(q) review. Historically, some licensees have developed
emergency plan implementing procedures that included the necessary
information needed for activities that are required to meet the
regulations, for example, procedures for notifications, dose
assessment, protective action recommendations, emergency
classifications and emergency action levels. The staff is not making
the use of Sec. 50.54(q) to review all changes to lower tier documents
a requirement, but acknowledges that using Sec. 50.54(q) as the
regulation to provide revision control of these lower tier documents
has been in place and supported by the NRC through the inspection and
licensing process.
Backfit Discussion
This RIS revision does not require any action or written response.
This RIS revision provides non-regulatory review guidance for licensees
and clarifies existing regulatory requirements licensees must follow
when proposing changes to their emergency plans. The NRC's Backfit
Rule, 10 CFR 50.109, applies to, among other things, the procedures
necessary to operate a nuclear power plant. To the extent that using a
license amendment process for making modifications to emergency plans
that reduce the effectiveness of the plans is considered a change, it
would be a change to the NRC's regulatory process for addressing
modifications to the emergency plan. The NRC's regulatory review
process is not a licensee procedure required for operating a plant that
would be subject to backfit limitations.
Further, the Backfit Rule protects licensees from Commission
actions that arbitrarily change license terms and conditions. In 10 CFR
50.54(q), a licensee requests Commission authority to do what is not
currently permitted under its license. The licensee has no valid
expectations protected by the Backfit Rule regarding the means for
obtaining the new authority that is not permitted under the current
license. For these reasons, this RIS revision does not constitute a
backfit under 10 CFR 50.109, and the staff did not perform a backfit
analysis.
Federal Register Notification
To be done after the public comments periods.
Paperwork Reduction Act Statement
This RIS revision does not contain information collections and,
therefore, is not subject to the requirements of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
Office of Management and Budget control number.
Contact
Please direct any questions about this matter to Don A. Johnson at
(301) 415-4040, or by e-mail: don.johnson@nrc.gov.
End of Draft Regulatory Issue Summary
Documents may be examined, and/or copied for a fee, at the NRC's
Public Document Room at One White Flint North, 11555 Rockville Pike
(first floor), Rockville, Maryland. Publicly available records will be
accessible electronically from the Agencywide Documents Access and
Management System (ADAMS) Public Electronic Reading Room on the
Internet at the NRC Web site, https://www.nrc.gov/NRC/ADAMS/.
If you do not have access to ADAMS or if you have problems in accessing
the documents in ADAMS, contact the NRC Public Document Room (PDR)
reference staff at 1-800-397-4209 or 301-415-4737 or by e-mail to
pdr@nrc.gov.
Dated at Rockville, Maryland, this 24th day of September 2009.
For the Nuclear Regulatory Commission.
Martin C. Murphy,
Chief, Generic Communications Branch, Division of Policy and
Rulemaking, Office of Nuclear Reactor Regulation.
[FR Doc. E9-23683 Filed 9-30-09; 8:45 am]
BILLING CODE 7590-01-P
