Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices 42699 

ehd.nrc.gov/EHD_Proceeding/home.asp, 

unless excluded pursuant to an order of 

the Commission, an Atomic Safety and 

Licensing Board, or a Presiding Officer. 

Participants are requested not to include 

personal privacy information, such as 

social security numbers, home 

addresses, or home phone numbers in 

their filings. With respect to copyrighted 

works, except for limited excerpts that 

serve the purpose of the adjudicatory 

filings and would constitute a Fair Use 

application, participants are requested 

not to include copyrighted materials in 

their works. 

Dated this 14th day of August 2009. 

For the Nuclear Regulatory Commission. 

Cynthia A. Carpenter, 

Director, Office of Enforcement. 

[FR Doc. E9–20333 Filed 8–21–09; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2009–0365] 

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 opportunity for public 

comment. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is 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 

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: Comment period expires October 

8, 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 

http://www.regulations.gov and search 

for documents filed under Docket ID 

NRC–2009–0365. Address questions 

about NRC dockets to Carol Gallagher at 

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 § 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 

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 


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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 

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 

(D.C. 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 § 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 


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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, 

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 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 

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 


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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. 

(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. 

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 

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. 

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 to 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 


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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 

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). 

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 

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– 

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, http://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 17th day 

of August 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. E9–20334 Filed 8–21–09; 8:45 am] 

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