Enhancements to Emergency Preparedness Regulations

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 50 and 52

[NRC-2008-0122]

RIN 3150-AI10

Enhancements to Emergency Preparedness Regulations

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Final rule.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending certain emergency preparedness (EP) requirements in its regulations that govern domestic licensing of production and utilization facilities. The final rule adds a conforming provision in the regulations that govern licenses, certifications, and approvals for new nuclear power plants. The final rule codifies certain voluntary protective measures contained in NRC Bulletin 2005-02, “Emergency Preparedness and Response Actions for Security-Based Events,” and generically applicable requirements similar to those previously imposed by Commission orders. In addition, the final rule amends other licensee emergency plan requirements based on a comprehensive review of the NRC's EP regulations and guidance. The requirements enhance the ability of licensees in preparing to take and taking certain EP and protective measures in the event of a radiological emergency; address, in part, security issues identified after the terrorist events of September 11, 2001; clarify regulations to effect consistent emergency plan implementation among licensees; and modify certain EP requirements to be more effective and efficient.

DATES:

This final rule is effective on December 23, 2011.

ADDRESSES:

You can access publicly available documents related to this document using the following methods:

•

NRC's Public Document Room (PDR):

The public may examine and have copied, for a fee, publicly available documents at the NRC's PDR, O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

•

NRC's Agencywide Documents Access and Management System (ADAMS):

Publicly available documents created or received at the NRC are available online in the NRC Library at

http://www.nrc.gov/reading-rm/adams.html.

From this page, the public can gain entry into ADAMS, which provides text and image files of the NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR reference staff at 1-(800) 397-4209, (301) 415-4737, or by email to

pdr.resource@nrc.gov.

•

Federal Rulemaking Web Site:

Public comments and supporting materials related to this final rule can be found at

http://www.regulations.gov

by searching on Docket ID NRC-2008-0122. Address questions about NRC dockets to Carol Gallagher,

telephone:

(301) 492-3668;

email: Carol.Gallagher@nrc.gov.

FOR FURTHER INFORMATION CONTACT:

Robert Beall, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;

telephone:

(301) 415-3874,

email: Robert.Beall@nrc.gov;

or Don Tailleart, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;

telephone:

(301) 415-2966,

email: Don.Tailleart@nrc.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Discussion

III. Public and Stakeholder Input to the Final Rule

IV. Section-by-Section Analysis

V. Implementation

VI. Guidance

VII. Criminal Penalties

VIII. Agreement State Compatibility

IX. Availability of Documents

X. Voluntary Consensus Standards

XI. Finding of No Significant Environmental Impact: Availability

XII. Paperwork Reduction Act Statement

XIII. Regulatory Analysis: Availability

XIV. Regulatory Flexibility Certification

XV. Backfit Analysis

XVI. Congressional Review Act

I. Background

After the terrorist events of September 11, 2001, the NRC determined that it was necessary to require certain modifications of EP programs for operating power reactor licensees to ensure continued adequate protection of public health and safety. These modifications were issued to licensees by NRC Order EA-02-026, “Order for Interim Safeguards and Security Compensatory Measures,” (Order EA-02-026), dated February 25, 2002. Order EA-02-026 was issued to the license holders of the 104 commercial nuclear power reactors in the U.S. This order required licensees to implement interim compensatory measures (ICMs) for the post-September 11, 2001, threat environment and take actions such as:

(1) Review security and emergency plans to maximize compatibility between the plans;

(2) Assess the adequacy of staffing plans at emergency response facilities, and for licensees with an onsite emergency operations facility (EOF), identify alternative facilities capable of supporting emergency response;

(3) Develop plans, procedures and training regarding notification (including non-emergency response organization (ERO) employees), activation, and coordination between the site and offsite response organizations (OROs);

(4) Conduct a review of staffing to ensure that collateral duties are not assigned to responders that would prevent effective emergency response; and

(5) Implement site-specific emergency action levels (EALs) to provide an anticipatory response to a credible threat.

Following the issuance of Order EA-02-026, the NRC conducted inspections of licensee EP programs and held meetings with nuclear power industry representatives to discuss the inspection results and the modifications licensees had made to their EP programs.

Also following the terrorist events of September 11, 2001, the NRC evaluated the EP planning basis for nuclear power reactors given the changed threat environment. In SECY-03-0165, “Evaluation of Nuclear Power Reactor Emergency Preparedness Planning Basis Adequacy in the Post-9/11 Threat Environment,” issued on September 22, 2003 (not publicly available), the NRC staff reported to the Commission that the EP planning basis remained valid, including scope and timing issues. However, the NRC staff also recognized that security events differ from accident events due to the planned action to maximize damage and loss of life and that the EP response to such events also differed. The NRC staff noted several EP issues that required further action to better respond to the post-September 11, 2001, threat environment.

On December 14, 2004, the NRC staff briefed the Commission on EP program initiatives. During the briefing, the NRC staff informed the Commission of its intent to conduct a comprehensive review of EP regulations and guidance. On February 25, 2005, in response to the Commission's staff requirements memorandum (SRM), SRM-M041214B, “Briefing on Emergency Preparedness Program Initiatives, 1 p.m., Tuesday, December 14, 2004, Commissioners' Conference Room, One White Flint North, Rockville, Maryland (Open to Public Attendance),” dated December

20, 2004, the NRC staff provided the Commission with a schedule of activities for the completion of the comprehensive review. The NRC staff, through SECY-05-0010, “Recommended Enhancements of Emergency Preparedness and Response at Nuclear Power Plants in Post-9/11 Environment,” issued on January 10, 2005 (not publicly available), requested Commission approval of the NRC staff's recommendations for enhancing, through new guidance documents, EP in the post-September 11, 2001, threat environment. In its SRM to SECY-05-0010, dated May 4, 2005 (not publicly available), the Commission directed the staff to provide the results of a comprehensive review of EP regulations and guidance. The SRM to SECY-05-0010 also approved the staff's recommendation to proceed with enhancements to address EP issues as described in SECY-05-0010. As a result, the NRC staff issued Bulletin 2005-02 (BL-05-02), “Emergency Preparedness and Response Actions for Security-Based Events,” dated July 18, 2005, which recommended enhancements that licensees could integrate into EP programs at power reactors. Bulletin BL-05-02 also sought to obtain information from licensees on their actions taken to implement Order EA-02-026 and to modify their EP programs to adjust to the current threat environment. Based on the results of the post-BL-05-02 inspections, meetings with members of the nuclear power industry, and licensees' responses to BL-05-02, the NRC determined that licensees were implementing strategies to satisfy Order EA-02-026 and enhance their programs to address the changed threat environment.

As directed by the Commission SRMs discussed above, the NRC staff conducted a comprehensive review of the EP regulatory structure, including reviews of regulations and guidance documents. As part of this review, the NRC staff met with internal and external stakeholders through several public meetings in 2005 and 2006 to discuss the elements of the EP review and plans to update EP regulations and guidance. Section III of this document provides a list of the public and other stakeholder meetings.

On September 20, 2006, the NRC staff provided the results of its review to the Commission in SECY-06-0200, “Results of the Review of Emergency Preparedness Regulations and Guidance,” dated September 20, 2006. In that paper, the NRC staff discussed the activities it had conducted to complete the review and provided its recommendation to pursue rulemaking for enhancements to the EP program. The NRC staff explained that the comprehensive review of the EP program identified several areas where the implementation of EP regulations and guidance, recent technological advances, and lessons learned from actual events, drills, and exercises had revealed to the NRC areas for potential improvement and increased clarity for the EP program. The staff divided the potential enhancements into two categories: security-based EP issues and other EP issues. The NRC staff evaluated each issue and assigned it a priority of high, medium, or low based on an analysis of the issue's relationship to reactor safety, physical security, EP, NRC strategic goals of openness and effectiveness, and stakeholder impact.

The NRC staff's outreach efforts, data gathering, research, and analysis led to the identification of 12 issues with a high priority, including six security EP issues and six non-security EP issues. In SECY-06-0200, the staff presented a framework for the potential enhancements to the EP regulations and guidance to address these issues, including steps for implementation, prioritization, and resource estimates. Based on its review, the NRC staff recommended that the Commission approve rulemaking as the most effective and efficient means to ensure that the high priority EP issues were resolved with an opportunity for participation by all interested stakeholders.

In its SRM to SECY-06-0200, dated January 8, 2007, the Commission approved the NRC staff's recommendation to pursue rulemaking and guidance changes for enhancements to the EP program. On April 17, 2007, the staff provided its rulemaking plan to the Commission. During the development of the plan, the NRC staff assessed the issues identified in SECY-06-0200 and discussed the feasibility of conducting rulemaking and updating guidance on all issues. The staff determined that the best course of action was to conduct rulemaking on the 12 issues identified in SECY-06-0200 as having a high priority, and to reassess the remaining issues at a later date. The decision to conduct rulemaking on the highest priority issues was made to allow a timelier rulemaking effort to occur and enable the staff to more completely assess the remaining lower priority issues.

Due to the similarities between two issues known in the rulemaking plan as “collateral duties” and “shift staffing and augmentation,” these issues have been partially combined in this final rule. Additionally, the Commission directed the NRC staff in SRM-M060502, “Staff Requirements—Briefing on Status of Emergency Planning Activities, (Two sessions) 9:30 a.m. and 1 p.m., Tuesday, May 2, 2006, Commissioners' Conference Room, One White Flint North, Rockville, Maryland (Open to public attendance),” dated June 29, 2006, to coordinate with the Department of Homeland Security (DHS) to develop emergency planning exercise scenarios that would ensure that EP drills and exercises will be challenging and will not precondition participant responses. This direction was incorporated into the rulemaking issue regarding the conduct of hostile action drills and exercises because it was so closely related. Bulletin BL-05-02 provided a definition of “hostile action” for use in EP programs: “An act toward an NPP [nuclear power plant] or its personnel that includes the use of violent force to destroy equipment, take hostages, and/or intimidate the licensee to achieve an end. This includes attack by air, land, or water using guns, explosives, projectiles, vehicles, or other devices used to deliver destructive force. Other acts that satisfy the overall intent may be included.”

In an effort to conduct a rulemaking that would be transparent and open to stakeholder participation, the NRC engaged stakeholders through various means during the development of this rule. The NRC discussed the proposed improvements to the EP regulations and guidance at several conferences with key stakeholders present including the 2007 NRC Regulatory Information Conference (RIC) and the 2008 National Radiological Emergency Preparedness (NREP) Conference. These meetings are discussed more fully in Section III of this document.

The NRC posted draft rule language on the Federal rulemaking Web site,

http://www.regulations.gov,

on February 29, 2008, and solicited stakeholder comments. The NRC considered the comments received on the draft rule language in the process of developing the proposed rule. The NRC continued the use of public meetings as a method to foster open communication with stakeholders when it held public meetings on March 5, 2008, and on July 8, 2008. At the March 5, 2008 meeting, the NRC staff discussed the draft preliminary rule language for the rulemaking on enhancements to EP regulations and guidance and answered stakeholders' questions on the rule language. At the July 8, 2008, meeting, the NRC staff discussed the public comments on the draft preliminary rule language and answered stakeholders'

questions on how these comments may be addressed in the proposed rule.

On January 9, 2009, the NRC staff provided the proposed rule to the Commission in SECY-09-0007, “Proposed Rule Related to Enhancements to Emergency Preparedness Regulations (10 CFR [Title 10 of the

Code of Federal Regulations

] part 50).” In its SRM to SECY-09-0007, dated April 16, 2009, the Commission approved the publication of the proposed rule. The NRC published the proposed rule on the enhancements to EP regulations for public comment in the

Federal Register

on May 18, 2009 (74 FR 23254). Because it received several requests to lengthen the public comment period, the NRC extended the deadline for the public comment period from August 3, 2009, to October 19, 2009. During the public comment period, the NRC and the Federal Emergency Management Agency (FEMA) jointly held 11 public meetings to discuss the proposed rule and related guidance documents. The NRC received a total of 94 submittals and from these submittals, 687 individual comments were identified.

On December 8, 2009, NRC and FEMA staff briefed the Commission on the status of the EP rulemaking and comments received during the public comment period. In addition, a panel of external stakeholders briefed the Commission on their comments and views regarding the proposed rule. In SRM-M091208, “Staff Requirements—Briefing on the Proposed Rule: Enhancements to Emergency Preparedness Regulations, 9:30 a.m., Tuesday, December 8, 2009, Commissioners' Conference Room, One White Flint North, Rockville, Maryland (Open to Public Attendance),” dated January 13, 2010, the Commission directed the NRC staff to continue working with FEMA in considering comments from State and local officials, and other interested stakeholders, to enhance the EP regulations and guidance. The Commission also directed the NRC staff to address the impacts of the rule and to consider providing a public draft of the rule language and guidance documents via the NRC public Web site while working with the Advisory Committee on Reactor Safeguards on the draft final rule.

On November 15, 2010, the NRC and FEMA held a public meeting to discuss the proposed implementation dates for the EP final rule. The feedback from this meeting, as well as all the previous interactions, informed the NRC's schedule for the implementation of the new EP requirements.

II. Discussion

The final rule applies to 10 CFR part 50 licensees that are currently subject to the EP requirements. The final rule similarly applies to certain applicants for construction permits under Part 50 with respect to their discussion of preliminary plans for coping with emergencies (§ 50.34(a)(10)), operating licenses under Part 50 (§ 50.34(b)(6)(v)), early site permits under Part 52 that choose to propose either major features of an, or a complete and integrated, emergency plan (§ 52.17(b)(2)), and combined licenses under Part 52 (§ 52.79(a)(21)). A discussion of which applicants may defer compliance with the requirements of this final rule is provided in Section V of this document.

An effective EP program decreases the likelihood of an initiating event at a nuclear power reactor proceeding to a severe accident. Emergency preparedness cannot affect the probability of the initiating event, but a high level of EP increases the probability of accident mitigation if the initiating event proceeds beyond the need for initial operator actions. As a defense-in-depth measure, emergency response is not normally quantified in probabilistic risk assessments. However, the level of EP could affect the outcome of an accident in that the accident may be mitigated by the actions of the ERO or, in the worst case, consequences to the public could be reduced through the effective use of protective actions. Enhancements to the level of EP in this manner enhance protection of public health and safety through improvements in the response to unlikely initiating events that could lead to severe accidents without mitigative response.

The NRC's EP requirements are based on 16 planning standards in § 50.47(b) that apply to onsite and offsite emergency response plans. The planning standards apply to onsite and offsite plans because, in making its licensing decision, the NRC looks at the application (or the licensee's activities in the case of existing facilities), the current State and local government emergency plans, and FEMA's recommendation, which is based on the content of the State and local plans. The FEMA regulations in 44 CFR part 350 also contain these planning standards, which are used to make its recommendation on the adequacy of the plans and capability of the State and local governments to implement them; however, FEMA's regulations address only offsite (State and local government) plans. The changes to § 50.47(b) in this final rule are designed to affect the onsite plans, not the offsite plans. The changes have been written in a way that is expected to limit the chance of unintended impacts on FEMA regulations.

This final rule does not affect the findings necessary for issuance of a renewed nuclear power operating license under 10 CFR part 54. As the Commission explained in the license renewal final rule (56 FR 64943; December 13, 1991) and again in revisions to that final rule (60 FR 22461; May 8, 1995), the scope of license renewal is limited to those issues that have a specific relevance to protecting the public health and safety during the license renewal period (

i.e.,

age-related degradation). Issues relevant to current plant operations, like emergency planning, fall within the purview of the current regulatory process and continue into the extended operation period of a license renewal. See also NUREG-1412, “Foundation for the Adequacy of the Licensing Bases,” dated December 1991. The Commission has affirmed repeatedly that “emergency preparedness need not be reviewed again for license renewal,” 71 FR 74848, 74852; December 13, 2006 (referencing 56 FR at 64966). The Commission stated that “[t]hrough its standards and required exercises, the Commission ensures that existing plans are adequate throughout the life of any plant even in the face of changing demographics and other site-related factors.” 71 FR at 74852 (quoting 56 FR at 64966). This basic determination is reflected in the NRC's regulations at § 50.47(a), in which a new finding on emergency planning issues is not required for license renewal.

The discussion of the amendments in this final rule is divided into two sections: Section II.A for security-related EP issues and Section II.B for non-security related EP issues. The security-related issues are topics that address subjects similar to certain requirements in Order EA-02-026 and the guidance in BL-05-02. The non-security related issues are high priority items that resulted from the comprehensive review of EP regulations and guidance.

A. Security-Related EP Issues

The NRC is enhancing its EP regulations by incorporating changes that clearly address EP actions for hostile action. Some of the changes are based on requirements in Order EA-02-026 that was issued to ensure adequate protection of the public health and safety and common defense and security. After the issuance of Order EA-02-026, however, the Commission took several additional steps to ensure

adequate protection of the public health and safety and common defense and security, including the issuance of Order EA-02-261, “Access Authorization Order,” issued January 7, 2003 (68 FR 1643; January 13, 2003); Order EA-03-039, “Security Personnel Training and Qualification Requirements (Training) Order,” issued April 29, 2003 (68 FR 24514; May 7, 2003); Order EA-03-086, “Revised Design Basis Threat Order,” issued April 29, 2003 (68 FR 24517; May 7, 2003); the Design Basis Threat (DBT) final rule (72 FR 12705; March 19, 2007); and the Power Reactor Security Requirements final rule (74 FR 13926; March 27, 2009). As a result of these adequate protection requirements, the Commission has determined that the existing regulatory structure ensures adequate protection of public health and safety and common defense and security. Therefore, the EP changes in this final rule that are based on the requirements of Order EA-02-026 are not necessary to ensure adequate protection during hostile action. These amendments are considered enhancements to the current EP regulations. However, licensees' implementation of these enhancements will result in a substantial increase in EP and the protection of public health and safety.

1. On-Shift Staffing Analysis

The NRC is concerned that on-shift ERO personnel who are assigned to emergency plan implementation functions may have numerous tasks or multiple responsibilities that would prevent timely performance of their assigned emergency plan tasks. The requirements for on-shift responsibilities are addressed in § 50.47(b)(2) and Part 50, Appendix E, Section IV.A. The former regulations did not specifically require that on-shift personnel assigned to emergency plan implementation must be able to implement the plan effectively without having competing responsibilities that could prevent them from performing their primary emergency plan tasks. The NRC regulations and guidance concerning licensee EROs are general in nature to allow some flexibility in the number of on-shift staff required for response to emergency events. This sometimes has resulted in the inadequate completion of emergency functions required during an emergency event. The NRC issued Information Notice (IN) 91-77, “Shift Staffing at Nuclear Power Plants,” dated November 26, 1991, to alert licensees to problems that could arise from insufficient on-shift staff for emergency response. The IN highlighted the following two events:

• A fire at one plant in April 1991 resulted in the licensee's failure to notify some key emergency response personnel (communication function). The need to staff the fire brigade and perform numerous response actions required by the event resulted in a heavy workload for the shift staff.

• A fire, loss of offsite power, and reactor trip at another plant in June 1991 resulted in difficulties in classifying the event, notifying required personnel, implementing emergency operating procedures, and staffing the fire brigade. Insufficient staff contributed to the licensee's failure to make a timely Notification of Unusual Event.

The NRC issued IN 93-81, “Implementation of Engineering Expertise On-Shift,” dated October 12, 1993, to alert licensees of ineffective implementation of the requirement to provide adequate engineering expertise on shift. Each nuclear power plant is required to have a shift technical advisor (STA) to provide engineering and accident assessment expertise. However, some licensees had assigned additional response duties to STAs, such as communicator or fire brigade member, which could have resulted in overburdening the control room staff during an emergency event. One licensee had assigned the STA as fire brigade leader, which could have hindered the STA from performing the primary duty of providing accident assessment and engineering expertise.

After issuance of IN 91-77, event follow-up inspections indicated that challenges involving shift staffing and task allocation continued. The NRC initiated a study in 1995 to assess the adequacy of shift staffing for emergency response. The NRC published IN 95-48, “Results of Shift Staffing Study,” dated October 10, 1995, which cited several observations of inadequate staffing and also concluded that there could be a large workload for radiological support personnel during emergencies. Data was collected on the adequacy of nuclear power plant staffing practices for performing response activities during two accident scenarios, which were (1) a fire leading to reactor trip with complications, and (2) either a control room fire leading to evacuation and remote shutdown or a station blackout. Items of interest included the following:

• Licensees surveyed did not use a systematic process for establishing site-specific shift staffing levels.

• Licensees surveyed frequently assigned additional plant-specific tasks that were not specified by regulation to be performed by licensed and non-licensed operators during an event.

• Five of the seven licensees surveyed used licensed personnel to staff the fire brigade.

• Procedures varied significantly concerning licensed and non-licensed personnel staffing levels, and the number of non-licensed operators used on the night-shift varied greatly.

• Radiation protection and chemistry technicians of all the licensees surveyed had a high workload during the scenarios.

Multiple NRC inspection findings also indicate the need for regulatory clarity in the assignment of multiple responsibilities to on-shift ERO personnel. For example, in February 2003, one licensee revised its emergency plan to delete one of three communicators and assigned the communicator function to the STA as an additional duty. As previously stated, the primary emergency plan duty of the STA is to provide engineering and accident assessment expertise. The NRC determined that this emergency plan change was an inappropriate reduction in on-shift staff and assessed the change as a decrease in effectiveness of the emergency plan in violation of § 50.54(q). In April 2005, another licensee revised its emergency plan to allow the assignment of the on-shift health physics technician (HP Tech.) as the interim operations support center coordinator, a 30-minute augmented ERO responder. The HP Tech. had assigned emergency plan tasks including in-plant surveys, in-plant protective actions, and rescue/first aid. The NRC determined that this emergency plan change was an inappropriate assignment of augmentation staff duties to an on-shift responder and assessed the change as a decrease in effectiveness of the emergency plan in violation of § 50.54(q).

These findings demonstrated the need for amended regulations to explicitly limit on-shift ERO response duties to ensure that these emergency responders do not become overburdened during an emergency event. Having additional duties beyond the assigned emergency plan implementation functions could result in on-shift responders being overburdened, resulting in inadequate or untimely response.

The ICMs in Order EA-02-026 addressed on-shift staff responsibilities by requiring licensees to ensure that a sufficient number of on-shift personnel are available for integrated security plan and emergency plan implementation. Prior to issuance of the order, some licensees were utilizing security

personnel to implement the emergency plan when many of these responders would likely not be available due to a hostile action.

The NRC considered several options to resolve this issue. One option was to take no action, but this alternative would not have subjected new nuclear power reactor licensees to Order EA-02-026's requirement of an assessment to ensure adequate staff for integrated security plan and emergency plan implementation. Additionally, the shift staffing study referenced in IN 95-48 found that the licensees surveyed did not use a systematic process for establishing shift staffing levels and additional tasks, not required by regulation, were assigned to the licensed and non-licensed operators. This practice, if permitted to continue, could have resulted in operators being overburdened during an emergency. A second option was to allow licensees to use a voluntary program to ensure adequate shift staffing. However, many licensees have requested NRC permission to reduce on-shift staffing levels and the NRC would have expected this practice to continue. This could have increased the risk of over-burdening on-shift responders and resulted in inadequate or untimely response. Therefore, both of these options were considered unacceptable.

In the proposed rule, the NRC would have required nuclear power plant licensees to provide a detailed analysis to show that on-shift personnel assigned emergency plan implementation functions were not assigned any responsibilities that would prevent them from performing their assigned emergency plan functions. The NRC received several comments on this proposal, questioning the need for this regulation and suggesting that the proposed rule methodology should be placed in a regulatory guide, NUREG, or some other guidance document. The NRC disagrees with these comments and believes that a regulation is necessary to ensure consistent licensee implementation of on-shift emergency response staffing that is enforceable and not merely guidance. Therefore, the NRC is amending Part 50, Appendix E, Section IV.A, to address this issue, as discussed in Section IV of this document.

In the proposed rule, the NRC asked for public comment on whether the NRC should enhance its regulations to be more explicit in the number of ERO staff necessary for response to nuclear power plant emergencies. Specifically, the NRC requested comments on a draft staffing table that provided proposed staff functions and minimum staffing levels for the on-shift and augmenting ERO. The table was a modification of the guidance found in Table B-1 of NUREG-0654/FEMA-REP-1, “Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants,” dated November 1980, and incorporated lessons learned from years of NRC EP experience. Of the comments the NRC received, some comments supported and some opposed the inclusion of the table into regulations. The NRC acknowledges that because each site is different and site characteristics may dictate the size of the ERO staff, requiring compliance with standard staffing requirements would be an unreasonable approach to resolving this issue. For example, the NRC has approved some emergency plans with additional ERO staff due to site-specific circumstances, such as the lack of a local fire department or hospital. Therefore, the NRC is not specifying a standard ERO staffing table in its regulations.

In the proposed rule, the NRC asked for public comment on whether the NRC should add a requirement for non-power reactor licensees to perform a detailed analysis demonstrating that on-shift personnel can perform all assigned emergency plan implementation functions in a timely manner without having competing responsibilities that could prevent them from performing their emergency plan functions. The NRC received several comments that opposed a regulation imposing this requirement. The NRC agrees that this requirement is not necessary for non-power reactor licensees. Staffing at non-power reactors is generally small, which is commensurate with the need to operate the facility in a manner that is protective of public health and safety. The NRC reviews the staffing as part of initial reactor licensing. The functions of emergency staff are outlined in emergency plans and are tested through drills and exercises in accordance with NUREG-0849, “Standard Review Plan for the Review and Evaluation of Emergency Plans for Research and Test Reactors,” dated October 1983. Results are reviewed by the NRC during routine inspections. Therefore, the NRC has not included this requirement in the final rule.

2. Emergency Action Levels for Hostile Action

Section 50.47(b)(4) stipulates that emergency plans must include a standard emergency classification and EAL scheme. Part 50, Appendix E, Section IV.B, specifies that emergency plans shall include EALs that are to be used as criteria for determining the need for notification of State and local agencies, and participation of those agencies in emergency response. However, the former regulations did not require EALs for hostile action and did not address the issue of anticipatory response to hostile action. Although Order EA-02-026 and BL-05-02 addressed these issues, those improvements to the EAL requirements to address hostile action were only in orders and guidance. Thus, the NRC could not ensure consistent and effective implementation of these enhancements among existing and future licensees.

Order EA-02-026 required the declaration of at least a Notification of Unusual Event in response to a credible hostile action threat. In 2005, the NRC issued BL-05-02, which provided EAL enhancement examples for hostile action up to the General Emergency level. Bulletin BL-05-02 provided examples of EALs for all three EAL methodologies that could be implemented immediately without prior NRC approval (

i.e.,

NUREG-0654, NUMARC/NESP-007, “Methodology for Development of Emergency Action Levels,” and Nuclear Energy Institute (NEI) 99-01, “Methodology for Development of Emergency Action Levels”). It also pointed out that because of improvements in Federal agencies' information-sharing and assessment capabilities, hostile action emergency declarations can be accomplished in a more anticipatory manner, based on a credible threat, than the current method of making declarations for accidental events. This would enable earlier implementation of emergency response actions.

Although all nuclear power reactor licensees have implemented both the credible threat EAL required by Order EA-02-026 and the EAL enhancements specified in BL-05-02, licensees were not required to maintain the enhancements identified in the bulletin. This could have resulted in inconsistent EAL implementation among licensees for response to hostile action. Also, future licensees would not have been required to include these enhancements in their emergency plans. This final rule establishes consistent EALs across the nuclear power industry for hostile action. The ICMs and BL-05-02 provided enhancements to EAL schemes that would allow event declarations to be accomplished in a more anticipatory manner. This timeliness is of the utmost importance because EALs are used as criteria for determining the need for notification and participation of State and local agencies. The NRC is

codifying these enhancements to the EAL requirements addressing hostile action by revising Part 50, Appendix E, Section IV.B, as discussed in Section IV of this document.

The NRC considered other options to attempt to resolve these issues, such as taking no action or allowing voluntary action by licensees. These options were rejected since there would have continued to be no regulatory requirement for current or future licensees to incorporate EALs for hostile action in their emergency plans, nor would there be a consistent minimum level of implementation that the NRC had determined to be adequate.

In the proposed rule, the NRC asked for public comment on whether the NRC should expand to non-power reactor licensees the requirement for power reactor licensees to have hostile action EALs. Appendix E to 10 CFR part 50 cites Regulatory Guide (RG) 2.6, “Emergency Planning for Research and Test Reactors,” dated March 1983, as the guidance for the acceptability of research and test reactor emergency plans. Regulatory Guide 2.6 endorses ANSI/ANS 15.16-1982, “Emergency Planning for Research Reactors,” as an acceptable approach to non-power reactor emergency plans. The newly updated ANSI/ANS 15.16-2008 includes hostile action EALs. The NRC has commenced the process to update RG 2.6 to endorse ANSI/ANS 15.16-2008. The NRC has also determined that further analysis and stakeholder interactions are needed prior to changing the requirements for non-power reactor licensees. Therefore, the NRC has not included a requirement in the final rule for non-power reactor licensees to have hostile action EALs.

3. Emergency Response Organization Augmentation and Alternative Facilities

Section 50.47(b)(2) and Part 50, Appendix E, Section IV.C, require licensees to have the capability to augment the on-shift staff within a short period of time after the declaration of an emergency to assist in mitigation activities. To accomplish this, ERO members typically staff an onsite Technical Support Center (TSC) that relieves the control room (CR) of emergency response duties and allows CR staff to focus on reactor safety. The ERO members also staff an onsite Operational Support Center (OSC) to provide an assembly area for damage repair teams. Lastly, ERO members staff an EOF, usually located in close proximity to the plant, to function as the center for evaluation and coordination activities related to the emergency and the focal point of information provided to Federal, State, and local authorities involved in the response.

Section 50.47(b)(8) and Part 50, Appendix E, Section IV.E, require licensees to have adequate emergency facilities and equipment to support emergency response. However, § 50.47(b)(8) and the former Part 50, Appendix E, Section IV.E, did not require licensees to identify alternative facilities to support ERO augmentation during hostile action. During hostile action, ERO members would likely not have access to the onsite emergency response facilities, or the EOF if it is located within the licensee's owner-controlled area. Nevertheless these events still warrant timely ERO augmentation so responders can travel quickly to the site once access is allowed.

Order EA-02-026 required that licensees assess the adequacy of staffing plans at emergency response facilities during hostile action, assuming the unavailability of the onsite TSC, and identify alternative facilities capable of supporting event response. These facilities would function as staging areas for augmentation staff until the site was secured, which would minimize delays in overall site response by permitting ERO assembly without exposing responders to the danger of hostile action. The NRC inspections to evaluate the effectiveness of the implementation of the ICMs revealed variations in the identification and staffing of alternative emergency response facilities.

Bulletin BL-05-02 described how alternative locations for onsite emergency response facilities support EP functions during hostile action. It stated that the ERO is expected to be staged in a manner that supports rapid response to limit or mitigate site damage or the potential for an offsite radiological release. It also pointed out that some licensees have chosen not to activate elements of the ERO during hostile action until the site was secured. However, the NRC considers it prudent, for hostile action events outside of normal working hours, to fully activate ERO members to promptly staff alternative facilities, in order to minimize delays in overall site response. Bulletin BL-05-02 conveyed that, even during normal working hours, licensees should consider deployment of onsite ERO personnel to an alternative facility near the site during hostile action.

To resolve this issue, the NRC considered taking no regulatory action or continuing the voluntary implementation currently in place as a result of BL-05-02 and the guidance endorsed by NRC Regulatory Issue Summary (RIS) 2006-12, “Endorsement of Nuclear Energy Institute Guidance `Enhancements to Emergency Preparedness Programs for Hostile Action,' ” dated July 19, 2006. If no action had been taken, there would have continued to be no explicit regulatory requirement regarding the actions necessary during hostile action for the ERO to staff an alternative facility. The ERO members would likely not have access to the site during hostile action, but timely augmentation would still be necessary for adequate response. Taking no regulatory action may have resulted in inconsistent implementation of ERO augmentation guidelines, and less effective overall site response. The NRC also considered using a voluntary program; however, voluntary programs, such as those developed per the NEI guidance endorsed by RIS 2006-12, would not provide a consistent, NRC-approved means for addressing needed enhancements for hostile action. The use of voluntary programs would not have ensured long-term continuity of the enhancements for both licensees and applicants. Thus, the NRC is codifying the ICM requirement and the enhancement examples described in BL-05-02 concerning ERO augmentation to alternative facilities during hostile action in Part 50, Appendix E, Section IV.E, to maximize the effectiveness of the site response. These changes are discussed in Section IV of this document.

4. Licensee Coordination With Offsite Response Organizations During Hostile Action

A unique challenge posed by hostile action at a nuclear power plant is the increased demand on local law enforcement agencies (LLEAs) that are expected to implement portions of ORO emergency plans, as well as respond to the plant. The former § 50.47(b)(1) and Appendix E to Part 50 did not explicitly require licensees to coordinate with OROs to ensure that personnel are available to carry out preplanned actions, such as traffic control and route alerting by LLEAs, during hostile action directed at the plant.

Licensees are required to identify ORO support for emergency response as well as demonstrate that various ORO capabilities exist through biennial evaluated exercises. Licensees and OROs have successfully demonstrated these capabilities for many years. However, the NRC recognized that hostile action may challenge OROs in ways unforeseen at the time the current regulations were developed. For example, local law enforcement personnel may be assigned both

evacuation plan and armed response duties during hostile action. The NRC acknowledged this challenge when it issued Order EA-02-026 and included provisions that licensees address coordination with OROs for hostile action. Specifically, the order required that licensees develop plans, procedures, and training regarding coordination between the site and OROs and directed licensees to review emergency plans to ensure sufficient numbers of personnel would be available during hostile action.

The NRC subsequently became aware through inspections and communications with licensees that ORO plans must be reviewed to ensure sufficient numbers of personnel would be available to respond during hostile action. The NRC communicated this need to licensees and OROs through RIS 2004-15, “Emergency Preparedness Issues: Post-9/11,” dated October 18, 2004, which provided information on EP issues based on NRC staff observations from the EP component of force-on-force (FOF) exercises and lessons learned from the telephonic walk-through drills conducted with all power reactor sites between August and October 2005. In addition, DHS initiated the Comprehensive Review Program that conducted a review of site and ORO response to hostile action at every nuclear plant site. This review often identified a gap in ORO resource planning. Based on these findings and lessons learned from hostile action pilot program drills (

see

Section II.A.6 of this document), the NRC believes there is inconsistent implementation among licensees concerning effective coordination with OROs regarding the availability of adequate resources to respond to hostile action at a nuclear power plant.

Licensees and the supporting OROs have taken various actions to respond to this issue, but criteria for determining the adequacy of the licensee and ORO actions have not been established. The NRC considered encouraging industry to develop and implement a voluntary program; however, voluntary programs do not provide a consistent, NRC-approved means for addressing the needed enhancements in the post-September 11, 2001, threat environment. A voluntary approach would not have ensured consistent industry-wide implementation of the ICM requirements and there would have been no requirement for new licensees to incorporate the changes into their emergency plans.

The NRC is amending Part 50, Appendix E, Section IV.A.7, to explicitly include hostile action at the site as one of the types of emergencies that define the State, local, and Federal agencies that licensees must identify in their emergency plan along with the assistance licensees expect from them. These changes are discussed in Section IV of this document.

5. Protection for Onsite Personnel

The former § 50.47(b)(10) and Appendix E to Part 50 did not require specific emergency plan provisions to protect onsite emergency responders and other onsite personnel in emergencies resulting from hostile action at nuclear power plants. Licensees are required to provide radiological protection for emergency workers and the public in the plume exposure pathway emergency planning zone (EPZ), including actions such as warning of an emergency, providing for evacuation and accountability of individuals, and providing for protective clothing and/or radio-protective drugs. Many of these personnel are required by the site emergency plan that the licensee must follow and maintain. The emergency plan requires responders with specific assignments to be available on-shift 24 hours a day to minimize the impact of radiological emergencies and provide for the protection of public health and safety. However, in analyses performed after the terrorist attacks of September 11, 2001, the NRC staff determined that a lack of protection for emergency responders who are expected to implement the emergency plan could result in the loss of those responders and thus an inability to effectively implement the emergency plan.

The normal response actions for personnel protection, such as site evacuation, site assembly and accountability, and activation of onsite emergency response facilities, may not be appropriate in this instance because these actions may place at risk the response personnel necessary to mitigate plant damage resulting from the hostile action. Bulletin BL-05-02 pointed out that actions different than those normally prescribed may be more appropriate during hostile action, particularly an aircraft attack. This may include actions such as evacuation of personnel from potential target buildings and accountability of personnel after the attack has concluded. Precise actions would depend on site-specific arrangements, such as the location of personnel in relation to potential targets. Procedures would need to be revised to ensure plant page announcements are timely and convey the onsite protective measures deemed appropriate.

The NRC considered other options to attempt to resolve this issue. The NRC considered taking no additional regulatory action and relying upon continuation of the voluntary initiatives currently being implemented by licensees as a result of BL-05-02. Taking no action could have resulted in the vulnerability of onsite personnel during hostile action. Action is necessary to ensure effective coordination to enable licensees to more effectively implement their pre-planned actions. Voluntary programs do not provide a consistent, NRC-approved means for addressing needed enhancements. Further, the implementation of voluntary actions would not have ensured that these measures would be incorporated into emergency plans at new sites.

The NRC is revising Appendix E by creating new Section IV.I, to require licensees to protect onsite personnel during hostile action and to ensure the continued ability of the licensee to safely shut down the reactor and perform the functions of the licensee's emergency plan, as discussed in Section IV of this document.

6. Challenging Drills and Exercises

A basic EP principle is that licensees conduct drills and exercises to develop and maintain key skills of ERO personnel. Drill and exercise programs contribute to the NRC determination of reasonable assurance that licensees can and will implement actions to protect public health and safety in the unlikely event of a radiological emergency. Implementation of the current regulations provides reasonable assurance of adequate protection of public health and safety at every nuclear plant site.

In the unlikely event that a licensee faces hostile action, the response organization will encounter challenges that differ significantly from those practiced in long-standing drill and exercise programs because these programs have not included hostile action scenarios. The former NRC regulations addressing this issue were general in nature and did not explicitly require licensees to include hostile action scenarios in drills and exercises, nor did they directly allow the NRC to require specific scenario content. The NRC is amending its regulations to do so.

Following the terrorist attacks of September 11, 2001, the NRC conducted a review of the EP planning basis in view of the changed threat environment and concluded that the EP planning basis remains valid. The NRC observed licensee performance during numerous

hostile action EP exercises and tabletop drills as well as several security FOF exercises. The NRC also discussed security-based EP issues with licensees and Federal, State, and local EP professionals and advocacy groups and issued BL-05-02 to collect information from licensees on the enhancements to drill and exercise programs to address the hostile action contingency.

Through these efforts, the NRC concluded that, although EP measures are designed to address a wide range of events, response to hostile action can present unique challenges not addressed in licensee and ORO drills and exercises, such as:

• Extensive coordination between operations, security, and EP personnel;

• Use of the alternative emergency response facilities for activation of the ERO;

• Execution of initial response actions in a hostile environment (

i.e.,

during simulated hostile action);

• The need to shelter personnel from armed attack or aircraft attack in a manner very different from that used during radiological emergencies;

• Conduct of operations and repair activities when the site conditions prevent normal access due to fire, locked doors, security measures, and areas that have not yet been secured;

• Conduct of operations and repair activities with large areas of the plant damaged or on fire;

• Rescue of, and medical attention to, significant numbers of personnel; and

• Prioritization of efforts to protect plant equipment or to secure access to plant areas for repairs.

In response to BL-05-02, all nuclear power reactor licensees stated that they would develop and implement an enhanced drill and exercise program. Program elements were captured in NEI 06-04, Rev. 1, “Conducting a Hostile Action-Based Emergency Response Drill,” a guidance document developed by NEI. The NRC endorsed this document for use in a pilot program in RIS 2008-08, “Endorsement of Revision 1 to Nuclear Energy Institute Guidance Document NEI 06-04, `Conducting a Hostile Action-Based Emergency Response Drill,' ” dated March 19, 2008. However, implementation of these enhancements was voluntary, and the NRC could not require licensees to maintain these enhancements, absent issuance of an order or a regulation.

The NRC also became aware of a related issue regarding EP exercise scenarios. The NRC inspects licensee response during these exercises and FEMA evaluates the capabilities of OROs. Licensees have performed many evaluated EP exercises and understand NRC and FEMA expectations. Licensees design scenarios in coordination with State and local agencies to demonstrate all key EP functions in a manner that facilitates evaluation. As a result, scenarios have become predictable and may precondition responders to sequential escalation of emergency classifications that always culminate in a large radiological release. Current biennial exercise scenarios do not resemble credible reactor accidents in that the timing is improbable and the intermittent containment failure typically used is unlikely. Typical scenarios used by licensees in biennial exercises involve simulated accidents, such as a loss of coolant accident or a steam generator tube rupture. However, certain predictable artifacts emerge in almost all biennial exercise scenarios, including the following:

• The ERO will not be allowed to mitigate the accident before a release occurs;

• The release will occur after a General Emergency is declared;

• The release will be terminated before the exercise ends; and

• The exercise will escalate sequentially through the emergency classes.

In short, responders may be preconditioned to accident sequences that are not likely to resemble the accidents they could realistically face.

In SRM-M060502, dated June 29, 2006, the Commission directed the NRC staff to develop exercise scenarios in conjunction with DHS, as follows:

The staff should coordinate with DHS to develop emergency planning exercise scenarios which would help avoid anticipatory responses associated with preconditioning of participants by incorporating a wide spectrum of releases (ranging from little or no release to a large release) and events, including security-based events. These scenarios should emphasize the expected interfaces and coordination between key decision-makers based on realistic postulated events. The staff should share experiences of preconditioning or “negative training” with DHS.

As a result of the SRM, a joint NRC/FEMA working group was formed to review the development of emergency planning exercise scenarios. The working group was assigned the task of identifying the NRC and FEMA regulations that would require revision to enhance exercise scenarios and guidance to assist in the effective implementation of these regulations. The working group recommended several changes to the FEMA Radiological Emergency Preparedness (REP) Program Manual that comport with this final rule to address preconditioning and the incorporation of hostile action exercise scenarios.

The FEMA held focus group meetings in several FEMA regions to discuss potential policy changes to the REP Program Manual. The NRC supported these meetings to facilitate questions as they related to the EP rulemaking issue of challenging drills and exercises. For example, stakeholders voiced opinions on the requirements for the development and review of exercise scenarios, whether all emergency classification levels (ECLs) must be included in each exercise or if one or more ECLs can be skipped, how radiological release conditions and options could vary, and if a spectrum of scenarios will be varied to create more realistic and challenging exercises. Comments received from the different focus groups and stakeholders informed this rulemaking, new guidance documents associated with this rulemaking, and an update to the REP Program Manual.

A regulatory change is necessary to enhance scenario content to include hostile action scenarios and reduce preconditioning through a wide spectrum of challenges. This change will improve licensee ERO capability to protect public health and safety under all accident scenarios as well as reverse any trend toward preconditioning.

The NRC also considered not making any change to the regulations, but rejected that option because it would not adequately address the concerns previously discussed. The NRC also discussed the use of voluntary programs and although this option could be successful, the NRC could not require that changes made would be permanent and consistent across all sites.

The NRC is revising Appendix E, Section IV.F, to address these issues, as discussed in Section IV of this document.

B. Non-Security Related EP Issues

The remaining changes are new or amended requirements that result in a substantial increase to public health and safety because they maintain or strengthen the ability of licensees to effectively implement their emergency plans.

1. Backup Means for Alert and Notification Systems

The regulations for alert and notification system (ANS) capabilities are found in § 50.47(b)(5) and Part 50, Appendix E, Section IV.D.3, and require licensees to establish the capability to promptly alert and notify the public if there is an emergency event while meeting certain ANS design objectives.

The former regulations did not require backup power for sirens or other backup ANS alerting capabilities when a major portion of the primary alerting means is unavailable. The regulations also did not address backup notification capabilities. If a major portion of a facility's ANS is unavailable and no backup exists, then the public may not be promptly alerted of an event at the facility and the protective actions to be taken, which could affect the public's response to the event.

An ANS provides the capability to promptly alert the populace within the plume exposure pathway EPZ of a nuclear power plant in case of an emergency event and to inform the public what protective actions may need to be taken. The predominant method used around U.S. nuclear power plants for alerting the public is an ANS based on sirens to provide an acoustic warning signal. Some sites employ other means, such as tone alert radios and route alerting, as either primary or supplemental alerting methods. The public typically receives information about an event and offsite protective actions via emergency alert system (EAS) broadcasts or other means, such as mobile loudspeakers.

In several instances, nuclear power plants have lost all or a major portion of the alert function of an ANS for short time periods for various reasons, such as damage to ANS components caused by severe weather, loss of offsite alternating current (AC) power, malfunction of ANS activation equipment, or unexpected problems resulting from ANS hardware/software modifications. In other situations, the notification capability has been lost (

e.g.,

the inability to activate tone alert radios, which are used to provide both an alert signal and notification function).

The NRC has issued multiple INs to document the circumstances when ANS failures have occurred, including IN 2002-25, “Challenges to Licensees' Ability to Provide Prompt Public Notification and Information During an Emergency Preparedness Event,” dated August 26, 2002; IN 2005-06, “Failure to Maintain Alert and Notification System Tone Alert Radio Capability,” dated March 30, 2005; and IN 2006-28, “Siren System Failures Due to Erroneous Siren System Signal,” dated December 22, 2006. The inability to activate some tone alert radios because of a shorter tone activation signal permitted as part of EAS implementation was addressed in IN 1996-19, “Failure of Tone Alert Radios to Activate When Receiving a Shortened Activation Signal,” dated April 2, 1996. Without the ability to warn the population, the effectiveness of the notification element may be significantly reduced. Having a backup means in place would lessen the impact of the loss of the primary ANS.

Other events impacting ANS operability have involved the widespread loss of the electrical grid providing power to siren based systems, such as the electrical blackout in several areas of the northeastern U.S. and portions of Canada in August 2003. As discussed in RG 1.155, “Station Blackout,” dated August 1988, although the likelihood of failure of the onsite AC [alternating current] power system coincidental with the loss of offsite power is small, station blackout events may be substantial contributors to core damage events for some plants.

The U.S. Congress recognized that all emergency notification systems may not operate in the absence of an AC power supply and encouraged the use of newer alerting and notification technology. In U.S. House of Representatives Committee on Appropriations (House Appropriations Committee) Report 107-740, FEMA was directed to update its guidance on outdoor warning and mass notification systems and require all warning systems to be operable in the absence of an AC power supply. The House Appropriations Committee also urged FEMA to consult with other relevant agencies and revise the national standard for outdoor warning and mass notification to reflect state-of-the-art technology. Moreover, the Energy Policy Act of 2005 directed the Commission to require backup power for the emergency notification system, including siren systems, for nuclear power plants located where there is a permanent population, as determined by the 2000 decennial census, in excess of 15,000,000 within a 50 mile radius of the power plant. Therefore, it was appropriate that the NRC also considered changes to its existing regulations and guidance regarding warning systems for all nuclear power reactor licensees.

The NRC considered several options to attempt to resolve this issue, including reliance on ANS design review standards and related guidance documents to address ANS backup means. Several NRC and FEMA guidance documents, such as NUREG-0654 and FEMA-REP-10, “Guide for the Evaluation of Alert and Notification Systems for Nuclear Power Plants,” dated November 1985, contain detailed information on ANS capabilities and design review methodology. Additional information on ANS backup capabilities will be provided in revisions or supplements to these documents. As guidance, a provision for an ANS backup means would not be considered a requirement and its applicability to existing approved ANS designs would be considered optional. As noted previously in this discussion, FEMA was also directed to update its guidance to require all warning systems to be operable in the absence of an alternating current power supply. However, guidance changes limited to backup power requirements for the alerting function would not address backup capabilities for other types of alerting devices or the ANS notification function. In summary, this option did not provide a regulatory resolution to ensure that nuclear power plant ANS designs include a backup method to the primary means for both alerting and notification, and thus the NRC considered this option to be unacceptable.

Use of a voluntary approach for ANS backup means was also considered. Some current nuclear power plant ANS designs address one or more aspects of backup ANS capabilities, such as providing backup power in the event primary power to sirens is lost, using backup route alerting when sirens are inoperable, designating multiple EAS broadcast stations to ensure that instructional messages can be transmitted, or using reverse 911 systems. A voluntary approach was considered as an option because State and local authorities can usually compensate for the temporary loss of some ANS capabilities. However, allowing licensees or applicants to voluntarily install backup ANS capabilities will not ensure that both the alerting and notification functions are addressed, or that new sites will have warning systems designed with comprehensive backup ANS capabilities. Given the importance of ANS to alert the public of an event at a facility and the protective actions to be taken, and without any voluntary industry commitment that existing or new warning systems will have a backup means available, the NRC considered a voluntary approach to be inappropriate and found this option unacceptable.

The NRC believes that nuclear power reactor licensees must be required to have backup ANS methods and therefore is amending its regulations to address backup capabilities for both the alert and notification functions. The NRC considered three alternatives for addressing this issue in rulemaking.

The first alternative would have added a regulatory requirement for ANS backup power. The most common warning system used at U.S. nuclear

power plants is based on sirens that are powered directly, or indirectly through batteries, by an AC power source. As noted previously in this discussion, the loss of power is not the only failure mode that can impact warning systems. Causes of past ANS inoperability problems have included the inability to detect siren failures, the inability to activate sirens, the failure to test and maintain personal home alerting devices, the use of telephone call-inhibiting devices, and the failure to provide and maintain distribution lists of tone alert radios. Thus, a regulatory requirement addressing only backup ANS power would not have eliminated any of these other failure modes. This approach would have prescribed one specific method as a backup means, precluding licensees (or applicants) and offsite officials from considering alternative methods, such as route alerting or newer communications technology, that may be more suitable for certain nuclear power plant sites. In summary, it would have addressed only one of several ANS failure modes (

i.e.,

loss of AC power) for one alerting method (

i.e.,

sirens). It would not have addressed backup methods for other types of alerting devices or any part of the notification process. Therefore, the NRC considered this approach to be unacceptable.

The second alternative would have required that the primary ANS be designed so no common single failure mode for the system existed; therefore, a backup system would not have been needed. This approach would have ensured that the entire ANS was designed and built to a very high level of reliability. Any equipment necessary for ANS activation and operation (

e.g.,

computers, radio transmitters and radio towers, plus the actual alerting devices and notification means) would have had redundant components and power sources as necessary to eliminate any common single failure mode, such as a widespread power outage affecting a siren based system. However, ensuring that all ANS common single failure vulnerabilities have been identified and adequately addressed would have been difficult. Even after extensive analysis and testing of a warning system, a common failure mechanism may not have become evident until the system was activated for an emergency event. For a siren based system, several additional sirens (with backup power capabilities) may have been needed to be installed to provide overlapping acoustic coverage in the event clusters of sirens fail and thus may have discouraged licensees at future nuclear power plant sites from using these systems due to the increased cost for installing additional sirens. This approach may not have been applicable to non-electronic primary warning systems based on other methods, such as route alerting. For these reasons, the NRC considered this approach to be unacceptable. Rejecting this approach does not mean that the issue of backup power for warning systems will be left unaddressed. As discussed previously, the House Committee on Appropriations directed FEMA to require all outdoor warning systems to be operable in the absence of AC power.

The third alternative was selected and revises Part 50, Appendix E, Section IV.D.3, to require a backup capability should the primary means of public alerting and notification be unavailable. These changes are discussed in Section IV of this document.

2. Emergency Declaration Timeliness

Emergency declaration is the process by which a licensee determines whether an off-normal plant condition warrants declaration as an emergency and, if so, which of the four emergency classes—Notification of Unusual Event, Alert, Site Area Emergency, or General Emergency—is to be declared. In its oversight of licensee EP programs, the NRC has observed several licensees whose responses in performing emergency declarations were inappropriately delayed. Between 2000 and 2009, the NRC identified 13 situations in which an emergency declaration was either not done or inappropriately delayed during an actual event, which resulted in findings and cited and non-cited violations. These situations may have been a result of a lack of a specific regulatory timeliness requirement.

Emergency declarations are fundamental to the licensee's EP program in that onsite and offsite emergency response activities are implemented in a staged, proportional manner, based upon the level of the declared emergency. If an emergency declaration is delayed, the subsequent emergency response actions may not be timely. Emergency response personnel, facilities, and equipment may not be in position should it become necessary to implement measures to protect public health and safety.

The NRC has issued generic communications to alert licensees of these concerns and to advise them of the NRC's expectation that emergency classifications

1

are made in a prompt manner. In 1985, the NRC published IN 85-80, “Timely Declaration of an Emergency Class, Implementation of an Emergency Plan, and Emergency Notifications,” to alert licensees of two instances in which declarations and/or notifications of an actual emergency condition were significantly delayed and to express the NRC expectation of timely emergency declarations. In 1995, the NRC found it necessary to publish Emergency Preparedness Position-2, “Emergency Preparedness Position (EPPOS) on Timeliness of Classification of Emergency Conditions,” to provide guidance to NRC staff in evaluating licensee performance in the area of timely classification. The NRC cited classification delays in actual events and exercises as the reason for issuing the guidance. The EPPOS-2 provided the NRC expectation that the classification should be made promptly following indications that conditions have reached an EAL threshold and that 15 minutes was a reasonable goal for completing the classification once indications are available to the control room operators. The NRC based that conclusion on the belief that 15 minutes is a reasonable period of time for assessing and classifying an emergency once indications are available to cognizant personnel, and that a delay in classification for up to 15 minutes would have a minimal impact upon the overall emergency response and protection of the public health and safety. The NRC noted that emergency classification schemes have reached a level of maturity in which the classification of emergencies can be accomplished in a relatively short period of time once the abnormal condition and associated plant parameters are known by cognizant licensee personnel. The EPPOS-2 stated that the 15-minute period was not to be viewed as a grace period in which a licensee could resolve a condition that had already exceeded an EAL threshold to avoid a declaration.

1

Early NRC generic communications routinely used the phrase “emergency classification” to denote the outcome of the process to assess, classify, and declare an emergency condition. This document uses the phrase “emergency declaration” in place of “emergency classification” except when summarizing an earlier document.

This 15-minute goal was not a regulatory requirement but rather a guideline for NRC staff evaluation of a licensee's performance in responding to an actual radiological emergency. This goal was subsequently incorporated as a criterion in the industry proposed and NRC-approved Reactor Oversight Process (ROP) EP Cornerstone performance indicators (PIs). Although the reported classification performance

during drills and exercises remains high, there have been several instances during actual events in which classifications were inappropriately delayed. Although these actual events did not warrant public protective measures, this may not always be the case.

The NRC considered the following options for addressing this regulatory problem. The first option, take no action, was rejected because it would not address the regulatory problem. The second option, continue to rely on the industry's voluntary PI, was rejected because the existence of the PI has not prevented untimely classifications during actual emergencies. Although these occurrences were associated with Notification of Unusual Events or Alerts, the observed weaknesses could also have occurred under different circumstances in which the potential impact to the public could have been greater. The third option, issue regulatory guidance, was rejected because although regulatory guidance is an appropriate mechanism for identifying acceptable means for complying with regulatory requirements, there was no regulatory requirement that emergency declarations meet any particular timeliness criterion. The fourth option, an amendment of the regulations, is the best course of action to ensure that licensees are aware that they are responsible for completing emergency declarations in a timely manner in the event of a radiological emergency.

The NRC also considered providing either a

performance

criterion or a

capability

criterion. Similar to the notification timeliness criterion in Appendix E, Section IV.D.3., in which the NRC requires licensees to be capable of notifying responsible State and local governmental agencies within 15 minutes after declaring an emergency, the NRC opted to propose a

capability

criterion, rather than an inflexible

performance

criterion. This approach allows licensees some degree of flexibility during an actual radiological emergency in addressing extenuating circumstances that may arise when an emergency declaration may need to be delayed in the interest of performing plant operations that are more urgently needed to protect public health and safety. These delays could be found acceptable if they did not deny State and local authorities the opportunity to implement actions to protect the public health or safety under their emergency plans and the cause of the delay was not reasonably within the licensee's ability to foresee and prevent. Based upon these considerations, the NRC is amending Part 50, Appendix E, Section IV.C, to address this issue by providing a

capability

criterion. These changes are discussed in Section IV of this document.

In the proposed rule, the NRC asked for public comment on whether the NRC should add requirements for non-power reactor licensees to assess, classify, and declare an emergency condition within 15 minutes and promptly declare an emergency condition. The NRC received several comments on these issues. The NRC believes there may be a need for the NRC to be aware of security related events early on so that an assessment can be made to consider the likelihood that the event is part of a larger coordinated attack.

The NRC also believes declarations for non-security related events should be made in a timely fashion, but not necessarily with the same urgency as security related events. For example, in 2008 a tornado damaged the building that houses a non-power reactor. Assistance from the NRC, which was coordinated between NRC headquarters and NRC Region IV, could have been deployed earlier and with more detailed information if the emergency information was available to the NRC earlier.

However, the NRC has determined that further analysis and stakeholder interactions are needed prior to changing the requirements for non-power reactor licensees. Therefore, the NRC has not included requirements in the final rule for non-power reactor licensees to assess, classify, and declare an emergency condition within 15 minutes and promptly declare an emergency condition.

3. Emergency Operations Facility—Performance Based Approach

Several nuclear power reactor licensees have submitted requests for NRC approval to combine EOFs for plants they operate within a State or in multiple States into a consolidated EOF. In some instances, the consolidated EOF is located at a substantial distance from one or more of the plant sites and is no longer considered a “near-site” facility, as required by former §§ 50.47(b)(3), 50.47(d)(1), 50.54(gg)(1)(i), and Appendix E, Sections II.H., IV.E.8., IV.E.9.c., and IV.E.9.d. Guidance documents, including NUREG-0696, “Functional Criteria for Emergency Response Facilities,” dated February 1981, and NUREG-0737, “Clarification of TMI Action Plan Requirements,” Supplement 1, “Requirements for Emergency Response Capabilities,” dated January 1983, that provide criteria for establishing and locating emergency response facilities also refer to the EOF as a near-site facility. However, the regulations and guidance did not explicitly define the term “near-site.” This regulatory structure resulted in confusion for licensees with reasonable technical bases for moving or consolidating EOFs that would no longer be considered “near-site” and led to requests for exceptions to NRC guidance and exemptions from NRC regulations to move or consolidate their EOFs.

In addition, neither regulations nor guidance documents addressed the capabilities and functional requirements for a consolidated EOF, such as capabilities for handling simultaneous events at two or more sites, or having provisions for the NRC and offsite officials to relocate to a facility nearer the site if they desire. Thus, licensees have been uncertain about when they need to submit requests for exceptions or exemptions, which alternative approaches to existing EOF distance and other facility criteria may be acceptable, and what additional capabilities they need to address for a consolidated EOF. A regulatory mechanism (§ 50.54(q)) is already in place that allows licensees to make changes to their emergency plans without prior Commission approval when certain conditions are met. This mechanism could have been applied to consolidation of EOFs if clearer criteria had been established. In the absence of clear criteria, several recent licensee requests to consolidate EOFs have been evaluated by the NRC staff and reviewed by the Commission on a case-by-case basis.

Each nuclear power plant site is required to have an EOF where the licensee provides overall management of its resources in response to an emergency and coordinates emergency response activities with Federal, State, local, and Tribal agencies. The original EOF siting criteria called for the facility to be located near the nuclear power reactor site and imposed a 20-mile upper limit (later modified by the Commission to 25 miles) for the distance between the site and the EOF. This upper limit was generally considered to be the maximum distance from the nuclear power reactor site within which face-to-face communications between the licensee, offsite officials, and NRC staff could be facilitated, and which also permitted the timely briefing and debriefing of personnel going to and from the site. However, advances in computer and communication technology after the original EOF siting criteria were established now allow EOF functions to be effectively performed independent of

distance from the site. Computer based systems allow plant parameter, meteorological data, and radiological information for multiple sites to be collected, analyzed, trended, and displayed in a remotely located facility. Data and voice communications between the EOF and other onsite/offsite emergency response facilities can be addressed through a variety of independent systems, such as microwave, telephone, internet, intranet, and radio, which provide a high degree of availability and reliability.

Furthermore, nuclear utility consolidation has resulted in initiatives to standardize fleet emergency plans, use consolidated EOFs, and staff EOFs by designated corporate personnel. Standardized plans, implementing procedures, and accident assessment tools, such as a common dose projection model, allow emergency responders in a consolidated facility to effectively perform their functions for multiple sites, even if the EOF is not a near-site facility. Consolidated facilities eliminate the need to duplicate work space, displays, communication networks, and other capabilities for each site. Consolidated facilities can also be located at or near corporate offices where nuclear support personnel designated to fill EOF positions can respond more quickly.

The Commission, in the SRM to SECY-04-0236, “Southern Nuclear Operating Company's Proposal to Establish a Common Emergency Operating Facility at Its Corporate Headquarters,” dated February 23, 2005, directed the NRC staff to consider resolving these issues through rulemaking. In that SRM, the Commission approved the proposal for a consolidated EOF for three nuclear power reactor sites operated by Southern Nuclear Operating Company at the company's corporate headquarters. The Commission also instructed the NRC staff to consider making “the requirements for EOFs more performance based to allow other multi-plant licensees to consolidate their EOFs, if those licensees can demonstrate their emergency response strategies will adequately cope with an emergency at any one of the associated plants.”

To address the EOF “near-site” and consolidation issues, the NRC considered maintaining EOF distance criteria as guidance only and to specify other EOF criteria in guidance rather than in the regulations. However, providing these criteria as guidance only would not have ensured that future applicants would follow the criteria. Thus, an EOF could have been located within 10 miles of a site with no backup facility provided, or could have been located beyond 25 miles of a site without providing a facility closer to a site for NRC site team and offsite response personnel. An EOF could have been implemented without meeting the performance based criteria. A licensee could have relocated or consolidated an existing approved facility without meeting all or some of the criteria and without prior Commission approval as long as the licensee determined that the provisions of § 50.54(q) were met. Under these circumstances, an EOF could have been implemented that may not have provided all of the capabilities that the NRC believes are necessary for such a facility to be fully effective. Therefore, the NRC determined that this option would not have been appropriate.

The NRC also considered revising the regulations (and providing associated performance based criteria) to allow an EOF to be located more than 25 miles from a nuclear power reactor site without prior Commission approval. The capability of existing EOFs located more than 25 miles from a site to function as effective emergency response facilities has been demonstrated in numerous exercises and several actual events. However, the NRC is concerned that locating an EOF beyond 25 miles from a site could adversely impact the ability of licensee and offsite responders to fulfill their responsibilities (

e.g.,

due to increased response times to a remotely located facility or less effective communications with responders at other locations). The potential adverse impacts of the EOF location must be fully considered and addressed, including consideration of the needs of offsite officials who also report to the EOF. Therefore, the NRC determined that the option to allow licensees to locate EOFs more than 25 miles from a site without prior Commission review and approval would not have been appropriate.

In summary, the NRC is amending its regulations (and associated guidance) to establish performance based criteria for all EOFs based on requirements and conditions previously imposed by the Commission on these facilities. Licensees will need to obtain prior Commission approval and provide a facility closer to the site in situations where the EOF is more than 25 miles from a site. This approach will ensure that an EOF has the capabilities necessary to be fully effective regardless of its location with respect to the nuclear power plant site, and that provisions are in place for a facility closer to the site for use by NRC site teams and offsite responders. The NRC is also amending its regulations (and guidance) to remove the references to an EOF as a “near-site” facility and to incorporate specific EOF distance criteria into the regulations, as discussed in Section IV of this document.

In a conforming change, the NRC is revising § 52.79(a)(17) to clarify that combined license applications need not address the requirement governing TSCs, OSCs and EOFs in § 50.34(f)(2)(xxv). Instead, the requirements in Appendix E, Section IV.E.8.a.(i) apply. That section accurately reflects the need for the combined license application to address an EOF; by contrast § 50.34(f)(2)(xxv) requires only applicants for construction permits (and not combined licenses) to address an EOF. The NRC considered, as an alternative to modifying § 52.79(a)(17), correcting § 50.34(f)(xxv) to remove the language limiting the requirement to address an EOF to construction permit applications. The NRC decided not to adopt that approach, but instead have the general requirements for EP, including Appendix E, apply to combined license applications by virtue of § 52.79(a)(21).

4. Evacuation Time Estimate Updating

The former § 50.47(b)(10) and Part 50, Appendix E, Sections II.G, III, and IV, required nuclear power plant operating license applicants to provide evacuation time estimates (ETEs) for the public located in the plume exposure pathway EPZ. These ETEs are used in the planning process to identify potential challenges to efficient evacuation, such as traffic constraints, and, in the event of an accident, to assist the onsite and offsite emergency response managers in making appropriate decisions regarding the protection of the public. The former regulations did not require any review or revision of ETEs following the initial licensing of the plant. Although some licensees do revise ETEs based on updated census data, the use of ETEs in evacuation planning is inconsistent and generally does not affect the development of public protective action strategies.

Nuclear power reactor operating license applicants are responsible for developing the ETE analysis for their respective sites. They submit the analysis to the NRC in support of their emergency plans, usually as a stand-alone document. Within the ETE analysis, there are multiple ETE values for different scenarios developed for combinations of variables and events under varying conditions. For example,

there are different ETE values based on season (summer or winter), day of the week (midweek or weekend), time of day (daytime or evening), and weather conditions (normal or adverse). Applicants include the results of the ETE analysis in the onsite emergency plan and in the emergency plan implementing procedures for protective action recommendations. The ETEs are also in the offsite emergency plans for the State and local governments within the plume exposure pathway EPZ.

In NUREG/CR-6953, Vol. 1, “Review of NUREG-0654 Supplement 3, Criteria for Protective Action Recommendations for Severe Accidents,” dated December 2007, the NRC presented the results of a study of its protective action recommendation guidance. The NRC concluded in the study that ETE information is important in developing public protective action strategies and should be used to identify enhancements to evacuation plans. The effectiveness of protective action recommendation strategies is sensitive to the ETE, and therefore, it is important to reduce the uncertainties associated with ETE numerical values. Improving the accuracy of ETE values helps licensees recommend and offsite officials determine the most appropriate protective action. For instance, in the study, the NRC determined that for some scenarios sheltering may be more protective than immediate evacuation if the evacuation time is longer than a few hours, depending on site-specific factors. Further, the NRC concluded that the effect of population change upon evacuation times should be understood by OROs and incorporated into offsite protective action strategies.

To address this issue, the NRC is amending the regulations to require licensees to assess changes to the EPZ population. The NRC believed that changes in infrastructure, or addition of a large subdivision to the EPZ, could also impact the ETE. The NRC consulted with Sandia National Laboratories (SNL), who are experts in emergency evacuations and have researched and developed several NRC studies related to evacuation (

e.g.,

NUREG/CR-6863, “Development of Evacuation Time Estimates for Nuclear Power Plants,” dated January 2005, NUREG/CR-6864, “Identification and Analysis of Factors Affecting Emergency Evacuations,” January 2005, and NUREG/CR-6953). Based upon their expert opinion, SNL confirmed that the major contributor to changes in ETE values is changes in population. Population changes have a direct correlation to the volume of vehicles on the roadway, which directly affects the roadway capacity. Although changes in infrastructure can impact roadway capacity, changes sufficient to impact the ETE by more than a few minutes, such as the addition of an interstate highway, take many years to plan and construct. Because population changes occur continuously, change in population is considered the more appropriate metric to monitor the potential effect on roadway capacity. Therefore, the NRC is revising the regulations to explicitly require ETE updates based on population changes that cause the ETE values within the analysis to exceed a specified threshold.

The NRC also considered using guidance as a means to solve the problem of the lack of specificity in regulations directing applicants and licensees on the periodicity for updating ETEs. Although the availability of more detailed guidance would provide applicants and licensees with the tools to better update their ETEs, this option would not have provided the regulatory means for enforcing the desired frequency of ETE updates and consistency of ETE determinations.

Therefore, the NRC is amending § 50.47(b)(10) and Part 50, Appendix E, Section IV, to require the periodic review and updating of ETEs. The NRC guidance for completing the ETE analysis and required ETE updates is contained in NUREG/CR-7002, “Criteria for Development of Evacuation Time Estimate Studies.”

5. Amended Emergency Plan Change Process

Applicants for operating licenses under Part 50 for nuclear power reactors, research reactors, and certain fuel facilities, and early site permits (as applicable) and combined licenses under Part 52 for nuclear power plants, are required by regulation to develop emergency plans that meet the requirements of Appendix E to Part 50 and, for nuclear power reactor license applicants, the standards of § 50.47(b). After the facility license was issued, the holder of the license was required by the former § 50.54(q) to follow and maintain in effect emergency plans that met the requirements of Appendix E and, for nuclear power reactor licensees, the standards of § 50.47(b). The former § 50.54(q) also provided a process under which a licensee could make changes to its approved emergency plan without prior NRC approval provided the changes would not decrease the effectiveness of the emergency plan as approved and the plan, as modified, would continue to meet applicable regulations. However, the NRC determined that the language of the former § 50.54(q) did not clearly describe the requirements the NRC intended to impose on licensees, leading to confusion and inefficiencies in implementation.

A licensee must follow and maintain the effectiveness of its emergency plan if the NRC is to continue to find, under § 50.54(s)(2)(ii), that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. The EP regulations generally refer to the onsite emergency plan as a stand-alone document. However, an emergency plan relies upon facility capabilities, equipment, and resources that are typically outside of the control of the licensee's emergency planning organization. The NRC has identified several occurrences in which licensee personnel outside of the emergency planning group have changed the status of capabilities and resources under their cognizance without considering the impact on the effectiveness of the emergency plan or without alerting the emergency planning group.

Several enforcement actions in the past few years have been associated with EALs being rendered ineffective by configuration changes made to instruments referenced in an EAL without the change being reflected in the EAL, or without a compensatory action being put into place. Examples include modifications to installed seismic instruments that eliminated the direct readout of acceleration needed for classifying a seismic event and changes in reactor vessel level criteria (in a boiling water reactor) being made without a conforming change being made to the EAL. In another finding, concrete barriers installed in a security-initiated change blocked a site access road required by the emergency plan to be used for site evacuation. Another licensee failed to provide adequate oversight on utility (external to the plant) personnel maintaining the site's ANS, resulting in degradation of that system and subsequent enforcement actions. Based on its experience in reviewing root cause analyses and corrective actions associated with inspection findings, the NRC believes that an underlying cause of these occurrences is often that the licensees' configuration control programs did not adequately consider the impact of configuration changes on the effectiveness of their emergency plans.

The NRC determined that the phrase “maintain in effect” in the former § 50.54(q) was not adequately clear in conveying the NRC expectation that an effective emergency plan also requires maintaining the various capabilities and resources identified and relied on in the

plan. The phrase “maintain in effect,” as applied to an emergency plan in § 50.54(q), has two senses: The first is that the plans are in force; the second is that the plans can achieve the desired result of providing reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. Accordingly, the NRC is amending § 50.54(q) to clarify that the regulatory intent is both senses by requiring licensees to follow and “maintain the effectiveness” of their approved emergency plans.

The former § 50.54(q) also provided a process under which a licensee could make changes to its approved emergency plan without prior NRC approval provided the changes did not decrease the effectiveness of the emergency plan as approved and the plan, as modified, continued to meet applicable regulations. Prior NRC approval was required for any change that decreased the effectiveness of the emergency plan. The NRC and licensees experienced significant difficulties in implementing this portion of § 50.54(q) because the former rule language did not define what constituted a decrease in effectiveness of an emergency plan nor did it identify the type of changes that would constitute a decrease in effectiveness of the plan. The lack of clear evaluation criteria resulted in regulatory inefficiencies, such as licensees submitting for review changes that did not rise to the level requiring prior NRC approval and enforcement actions due to licensees failing to submit changes that were later deemed to warrant such a review. A large fraction of the enforcement actions in the EP Cornerstone can be attributed to these findings.

The NRC attempted to resolve this issue through the publication of regulatory guidance. In 1998, the NRC issued EPPOS-4, “Emergency Plan and Implementing Procedure Changes,” to provide guidance to NRC inspectors regarding their review of licensees' emergency plan changes. In 2004, the NEI submitted two white papers proposing a definition of “decrease in effectiveness” for NRC consideration. The NRC could not reach consensus with NEI and thus, did not endorse the NEI guidance. In 2005, the NRC withdrew EPPOS-4 and issued RIS 2005-02, “Clarifying the Process for Making Emergency Plan Changes,” dated February 14, 2005, to (1) Clarify the meaning of “decrease in effectiveness,” (2) clarify the process for making changes to an emergency plan, and (3) provide some examples of changes that are not decreases in effectiveness. Although RIS 2005-02 provided useful guidance, the NRC and NEI have continued to discuss ways to improve the § 50.54(q) change process, including the use of a regulatory framework parallel to that of § 50.54(a)(3) for quality assurance programs, § 50.54(p)(2) for safeguards plans, and § 50.59, “Changes, Tests, and Experiments.”

During the development of this rulemaking, the NRC identified a concern regarding the process to be used by the NRC for reviewing proposed emergency plan changes. The former § 50.54(q) directed the licensee to submit such changes under the provisions of § 50.4, which provides the procedures for making certain submissions to the NRC. Some confusion existed as to whether all proposed emergency plan changes submitted under § 50.4 would result in a decrease in effectiveness and whether Commission review of such submissions was necessary. The final rule specifies that the license amendment process of § 50.90 is to be used when submitting a proposed emergency plan change that the licensee has determined constitutes a reduction in effectiveness of the plan. The final rule language addresses this clarification. (

See

Section IV of this document for further discussion.)

The NRC also considered other options for addressing the § 50.54(q) problems. Using a voluntary industry initiative was rejected because the NRC and NEI had yet to agree on the best approach to resolve the problems. Issuing more regulatory guidance was rejected because that approach had been tried but had not resolved the problems. The NRC determined that an amendment to the regulations, supplemented as necessary by regulatory guidance, is the best course of action to ensure that (1) The effectiveness of the emergency plans is maintained, (2) changes to the approved emergency plan are properly evaluated, and (3) any change that reduces the effectiveness of the plan is reviewed by the NRC prior to implementation.

Accordingly, the NRC is amending § 50.54(q) to replace the existing language and is making conforming changes in Part 50, Appendix E, Section IV.B. The NRC is issuing RG 1.219, “Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors,” to describe a method acceptable to the NRC for demonstrating compliance with the final rule.

6. Removal of Completed One-Time Requirements

The NRC is eliminating several regulatory provisions that required holders of licenses to take certain one-time actions to improve the state of EP following the Three Mile Island incident in 1979. These actions are complete and the requirements are no longer binding on any current licensee. Corresponding requirements for license applicants are provided in §§ 50.33 and 50.34.

The requirements being removed are:

(1) Section 50.54(r), which required licensees of research or test reactors to submit emergency plans to the NRC for approval by September 7, 1982, and, for the facilities with an authorized power level of less than 2 MW thermal, by November 3, 1982. There is no longer a need for this provision because this requirement has expired. The NRC is deleting this requirement and designating the section as “reserved.”

(2) Section 50.54(s)(1), which required nuclear power reactor licensees to submit State and local governmental emergency plans within 60 days of the November 3, 1980, effective date of the rule that added § 50.54(s)(1) to Part 50, and that date has elapsed. That portion of § 50.54(s)(1) that discussed the size of the EPZs was not identified for deletion in the proposed rule, but after further review the NRC has determined that it does not need to be retained. The size of EPZs for nuclear power reactors is addressed in other parts of the NRC's regulations. Section 50.33(g), which is applicable to the content of new Part 50 and Part 52 applications (with complete and integrated emergency plans), contains the same language regarding the size of EPZs as found in § 50.54(s)(1). Section 50.47(c)(2) also has the same language regarding the size of EPZs as §§ 50.33(g) and 50.54(s)(1). Moreover, Part 50, Appendix E, Section I, footnote 1, addresses the size of EPZs with language equivalent to §§ 50.33(g) and 50.54(s)(1). Therefore, the NRC is deleting § 50.54(s)(1) in its entirety and designating the section as “reserved.”

(3) Section 50.54(s)(2)(i), which required that nuclear power reactor licensee, State, and local emergency response plans be implemented by April 1, 1981. There is no longer a need for this provision because this requirement has expired. The NRC is deleting § 50.54(s)(2)(i), designating the section as “reserved.”

(4) Section 50.54(u), which required nuclear power reactor licensees to submit, within 60 days of the November 3, 1980, effective date of the rule that added § 50.54(u) to Part 50, to the NRC plans for coping with emergencies that meet the standards in § 50.47(b) and the requirements of Appendix E. There is no longer a need for this provision because this requirement has expired. The NRC is deleting this requirement

and designating the section as “reserved.”

The NRC is eliminating these completed one-time requirements in the interest of regulatory clarity. Eliminating these requirements will not relax any currently effective regulatory requirement and will cause no regulatory burden on any current or future licensee or applicant.

III. Public and Stakeholder Input to the Final Rule

A.

Public and Stakeholder Meetings

As part of its comprehensive assessment of the NRC's EP regulations and guidance and development of this rule, the NRC staff met with internal and external stakeholders, including FEMA management, on numerous occasions including the following:

1. Meetings with NRC regional EP inspectors in January 2005 and January 2006;

2. Meetings with State, local, and Tribal governments and nuclear power industry representatives at the NREP Conference on April 11-14, 2005, March 27-30, 2006, and April 7-10, 2008;

3. Public meeting with interested stakeholders on August 31 and September 1, 2005;

4. Public meeting with non-governmental organizations (NGOs) on May 19, 2006;

5. Public meeting with the NEI/nuclear power industry representatives on July 19, 2006;

6. Regional meetings with State and local representatives and nuclear power industry working groups that started in 2007;

7. NRC Regulatory Information Conference on March 16, 2007;

8. Public meeting with external stakeholders on March 5, 2008;

9. Meeting with nuclear power industry representatives at the 2008 NEI EP and Communications Forum;

10. Public meeting with external stakeholders on July 8, 2008;

11. Public meetings to discuss the proposed rule on enhancements to EP regulations and related guidance documents in June 2009 held jointly by the NRC and FEMA (a total of 11 public meetings);

12. Public meeting to discuss the proposed rule on enhancements to EP regulations and related guidance documents on September 17, 2009;

13. Commission meeting to provide an overview of comments received by the NRC and FEMA during the proposed rule public comment period and remaining milestones in the EP rulemaking process on December 8, 2009; and

14. Public meeting to discuss feedback on proposed implementation dates for the final rule on November 15, 2010.

The NRC also met routinely with representatives of FEMA to coordinate issues of mutual interest and to keep them informed of NRC EP activities. These meetings allowed NRC and FEMA to collaborate on rulemaking and guidance issues, and to ensure alignment and regulatory consistency. In addition, FEMA attended the NRC public meetings regarding the NRC's EP rulemaking, and co-hosted 11 of the public meetings with the NRC held after the issuance of the proposed rule.

B.

Public and Stakeholder Comments Received

At the April 11, 2005, NREP Conference, the NRC and FEMA conducted a workshop with stakeholders. The workshop covered a broad range of EP topics. Unanswered stakeholder comments and questions were recorded by NRC staff, and the NRC and FEMA responded to those questions and comments in “Discussion of NREP `Parking Lot' Items.”

The NRC conducted a public meeting on August 31-September 1, 2005, to obtain input regarding EP requirements and guidance for commercial nuclear power plants. The first day of meetings involved a roundtable discussion of topics related to the review of EP regulations and guidance. During the second day, the NRC staff and stakeholders addressed the “Discussion of NREP `Parking Lot' Items” from the April 2005 NREP conference and other stakeholder comments and questions. The NRC requested comments in writing before the August 31-September 1, 2005, meeting and also received comments at the meeting. In addition to comments transcribed from the 2-day public meeting, the NRC accepted written comment submissions until October 31, 2005.

The NRC and FEMA responded to generic comments from the August 31-September 1, 2005, meeting and comments received thereafter in “Summary and Analysis of Comments (Received Between August 31 and October 31, 2005).” Site-specific comments from the public meeting were addressed in “Summary and Analysis of Site-Specific Comments (Received Between August 31 and October 31, 2005).”

The NRC also received comments on the review of the EP regulations and guidance for nuclear power plants at public meetings with stakeholders on May 19, 2006, and July 19, 2006. The May 19, 2006, meeting was transcribed. The NRC staff informed the meeting participants that their comments would be presented to the Commission in a September 2006 SECY paper. These comments were provided to the Commission in an attachment to SECY-06-0200 and, like the stakeholder comments from 2005, were used to inform the staff's recommendations to the Commission in SECY-06-0200.

The NRC received three comment letters that focused on the draft preliminary rule language posted for comment on

http://www.regulations.gov

on February 29, 2008. One comment letter was submitted by the Commonwealth of Pennsylvania, one was submitted by NEI, and one was submitted by the Union of Concerned Scientists on behalf of several NGOs. These comments were addressed as part of the development of the proposed rule.

The proposed rule was published on May 18, 2009, and the public comment period closed on October 19, 2009. The NRC received a total of 94 submittals and from these submittals, 687 individual comments were identified. Some of the comments and the NRC's responses are discussed throughout this document. A detailed discussion of the public comments and the NRC's responses is contained in a separate document (

see

Section IX of this document). The NRC also received comments on issues that are outside the scope of this rule and on regulatory provisions that are not being revised in this rule. The NRC determined that these comments did not support changing the scope of the final rule.

C.

Proposed Rule Specific Request for Comments

In the proposed rule, the NRC requested comments on whether the NRC should issue regulations requiring that licensees train responders on and implement the Incident Command System (ICS) to improve the interface with OROs during an event at a nuclear power plant. Homeland Security Presidential Directive 5 (HSPD-5) requires all Federal departments and agencies to adopt the National Incident Management System (NIMS) and use it in their individual incident management programs and activities, as well as in support of all emergency response actions taken to assist State, Tribal, and local governments. Although NIMS represents a core set of doctrines, concepts, principles, terminology, and organizational processes that enables incident management, it also utilizes the ICS for command, operations, planning, logistics, and finance/administration functions to manage domestic incidents.

The NIMS/ICS are also widely used by State, tribal, and local governments, including when these entities are engaged in emergency response activities with nuclear power reactor licensees. However, licensees are not currently required to adopt NIMS/ICS, so the potential exists for confusion or miscommunication between OROs who utilize NIMS/ICS as an incident management system and the associated power reactor licensees who do not use the same system. The NRC observed some of these coordination challenges during the nuclear power industry's voluntary three year EP hostile action drill program initiative, which was conducted in response to BL-05-02 and concluded in December 2009. Ideally, both OROs and licensees should use the same or a compatible incident management system to effectively communicate with each other and improve their individual and joint response capabilities.

Nevertheless, the NRC recognizes that HSPD-5 does not require the private sector to adopt NIMS/ICS. The NRC also understands that requiring its nuclear power reactor licensees to implement NIMS/ICS would impose upon licensees a specific type of incident command structure stipulated by HSPD-5. Any future changes to HSPD-5 or NIMS/ICS could require corresponding rulemaking changes by the NRC. Moreover, if the NRC were to compel its nuclear power reactor licensees to use a specific incident management program, that program still could be different than incident management systems adopted by OROs that comply with laws promulgated by other governmental organizations. Thus, despite the NRC's efforts to promote consistency, these potentially conflicting regulatory authorities could prove to be incompatible during ICS activities at the reactor sites. For example, the incident commander during the onset of a hostile action incident at a nuclear facility will most likely be a local law enforcement officer, whose authority derives from the local or State jurisdiction and not from the NRC.

Section 50.47(b)(6) of the NRC's regulations states that “Provisions exist for prompt communications among principal response organizations to emergency personnel and to the public.” In this final rule, the NRC is amending Part 50, Appendix E, Section IV.A.7, to require licensees to include in their emergency plans the “[i]dentification of, and assistance expected from, appropriate State, local, and Federal agencies with responsibilities for coping with emergencies, including hostile action at the site.” Together, these regulations require licensees to know which OROs would respond during an emergency and how to communicate with those OROs. A licensee's use of a command structure that is compatible with the applicable OROs' command structure (

e.g.,

NIMS/ICS) would enhance communication and coordination between OROs and licensees and facilitate the licensee's compliance with the § 50.47(b)(6) standard and the requirements of Appendix E, Section IV.A.7. The NRC's regulations, as amended by this final rule, contain adequate requirements to ensure that licensee compliance with these regulations would result in effective communication between OROs and licensees during emergencies. Therefore, the NRC is not requiring that NIMS/ICS become the sole means of incident command management for licensees.

Comments received by the NRC in response to other specific requests for comments in the proposed rule are addressed in Sections II and IV of this document.

IV. Section-by-Section Analysis

The Commission is amending portions of § 50.47, “Emergency plans;” § 50.54, “Conditions of licenses;” Part 50, Appendix E, “Emergency Planning and Preparedness for Production and Utilization Facilities;” and § 52.79, “Contents of applications; technical information in final safety analysis report.”

1. Section 50.47 Emergency Plans

The NRC is amending § 50.47(b)(3) to remove the reference to the EOF as a “near-site” facility. The final rule provides criteria in Part 50, Appendix E, Section IV.E.8, regarding EOF distance from a nuclear power reactor site and for a performance based approach for EOFs, specifying that these facilities must meet certain functional requirements rather than requiring that they be located within a certain distance of the plant. The intent of this change is discussed in the section on changes to Appendix E, Section IV.E.8. (A discussion of this issue is also provided in Section II.B.3 of this document.)

The final rule amends § 50.47(b)(10) to require licensees to review and update their ETEs periodically. Changes to Appendix E to Part 50 provide the required frequency and details of the ETE updates and submissions to the NRC. Although requirements for ETEs are found in both § 50.47(b) and in Appendix E to Part 50, the level of detail between them differs. Section 50.47(b) establishes the EP planning standards that licensees must meet, whereas Appendix E sets forth more detailed implementation requirements. (A discussion of this issue is also provided in Section II.B.4 of this document.)

This new requirement ensures that ETEs are reviewed periodically to determine whether population changes have caused significant changes in the ETE values. The NRC review of ETE updates will ensure they are performed routinely, are consistent across the industry, and are technically sound. The NRC guidance will provide more details of NRC expectations for development of an adequate ETE analysis, as well as provide NRC reviewers with guidance on the review of ETE updates. The NRC expects that the updated ETEs will be shared with OROs to be incorporated into offsite protective action strategies.

The NRC received several comments that suggested that the proposed rule language of § 50.47(b)(10) be revised to accommodate changes to ETE update criteria. Two commenters stated that the threshold for ETE updates should be based on a population sensitivity study that would assess the effect of a population change on the ETE. Two commenters argued that the ETE updates should be based on changes in population density rather than absolute population change. The NRC agrees that the ETE update criteria should be changed and should be based on the impact that a population change has on the ETE instead of a percent change in population. However, the details of the revised ETE update criteria should be included in Appendix E to Part 50 where more detailed implementation requirements are found. Two commenters argued that the proposed rule language should be revised to eliminate the requirement for submission of ETEs to the NRC for review and approval. The NRC believes that NRC review is necessary for consistent implementation, but the NRC will not approve the ETE updates. See the discussion under Appendix E to Part 50 in this section of the document for further information on this topic.

The NRC is amending § 50.47(d)(1) to remove the reference to the EOF as a “near-site” facility. The final rule provides criteria in Part 50, Appendix E, Section IV.E.8, regarding EOF distance from a nuclear power reactor site and for a performance based approach for EOFs, specifying that these facilities will need to meet certain functional requirements rather than requiring that they be located within a certain distance of the plant. The intent of this change is discussed in the section on changes to Appendix E, Section IV.E.8. (A

discussion of this issue is also provided in Section II.B.3 of this document.)

2. Section 50.54 Conditions of Licenses

The NRC is amending § 50.54(q) in its entirety. Section 50.54(q)(1) defines four terms whose meanings are limited to application within § 50.54(q) in the final rule. Section 50.54(q)(1)(i) defines a “change” to the emergency plan as an action that results in modification or addition to, or removal from, the licensee's emergency plan. All such changes are subject to § 50.54(q) unless another regulatory change process is controlling. For example, a plant configuration change that removes a piece of equipment identified and relied upon in the emergency plan could also be subject to the requirements of § 50.59 and a technical specification change may also be involved.

In the proposed rule, § 50.54(q)(1)(i) defined what would have constituted a change to the emergency plan. The NRC received comments that asked the NRC to remove the phrase “resources, capabilities, and methods identified in the plan” from the final rule language for this definition. The NRC agrees with these comments and made this change to the final rule to place emphasis on the content of the emergency plan. Although resources, capabilities, and methods are identified in the emergency plan, not all of these will necessarily be under the control of the licensee. For example, the licensee's emergency plan may identify the plans and capabilities of OROs. A change to an ORO plan is not subject to the § 50.54(q) change process, but the modifications to the licensee's emergency plan to reflect that change are subject to the § 50.54(q) change process.

The § 50.54(q)(1)(ii) definition of “Emergency plan” in the final rule encompasses any document that describes the programmatic methods that the licensee uses to maintain preparedness and to respond to emergencies, and to demonstrate compliance with the requirements of Appendix E, and for nuclear power reactors, the planning standards of § 50.47(b). In response to a stakeholder comment on § 50.54(q)(1)(ii) in the proposed rule, the NRC has revised this definition in the final rule by removing the proposed reference to “emergency planning functions,” and replacing it with “methods for maintaining emergency preparedness and responding to emergencies.” Sub-tier documents, such as emergency plan implementing procedures, are not ordinarily subject to the § 50.54(q) change process because these procedures generally only provide instructions in performing the programmatic methods identified and described in the emergency plan. However, if a licensee were to relocate a programmatic description to another document, that description will remain subject to the § 50.54(q) change process. For example, if a licensee were to relocate the details of its emergency classification scheme from the emergency plan to a wall chart posted in the control room, the wall chart would be subject to the § 50.54(q) change process. The definition also emphasizes, by incorporation, the role of the licensee's original emergency plan approved by the NRC in minimizing the likelihood that a series of incremental changes, many of which may not have been reviewed by the NRC, over time will constitute a reduction in effectiveness of the NRC approved emergency plan.

Section 50.54(q)(1)(iii) in the final rule defines the term “emergency planning function” in terms of a capability or resource necessary to prepare for and respond to a radiological emergency. During the development of the EP Cornerstone of the ROP, a group of EP subject matter experts, including NRC staff and nuclear power industry stakeholders, with input from the public, developed a series of planning standard functions that are used in determining the significance of inspection findings. These planning standard functions are paraphrases of the broadly-worded § 50.47(b) planning standards and the corresponding requirements in Appendix E to Part 50 in terms of the significant functions that need to be accomplished, or the capabilities that need to be in place, to maintain the effectiveness of a licensee's emergency plan and emergency response capability. Within the EP Cornerstone, the significance of inspection findings depends on whether the planning standards can be accomplished (

i.e.,

loss of planning standard function) or can be accomplished only in a degraded manner (

i.e.,

degraded planning standard function). The characterization of a reduction in effectiveness in the final rule capitalizes on this earlier effort in that any degradation or loss of a planning standard function is deemed to constitute a reduction in effectiveness. The NRC is using the phrase “emergency planning function” in lieu of “planning standard function” as used in the ROP to allow the definition to be applicable to licensed facilities that are subject to Appendix E, but are not subject to the planning standards of § 50.47(b). The emergency planning functions have been established in RG 1.219 along with examples of typical emergency plan changes that are expected to constitute a reduction in effectiveness and examples of changes that are not.

The emergency planning functions do not replace or supplement the regulations upon which they were based and, as such, compliance with these functions is not required. They are only used to differentiate between changes that the licensee is allowed to make without prior NRC approval and those that require prior NRC approval. The NRC did not establish these emergency planning functions in regulations because the underlying regulations already exist, and the expression of the emergency planning functions differs between nuclear power reactors, non-power reactors, and fuel facilities licensed under Part 50 or Part 52. The RG 1.219 discusses these emergency planning functions for nuclear power reactor licensees.

In response to the definition of “emergency planning function” in proposed § 50.54(q)(1)(iii), the NRC received a stakeholder comment that suggested that the planning standards of § 50.47(b) should be used for determining reductions in effectiveness, in lieu of the proposed emergency planning functions, since compliance is based on meeting planning standards. The NRC disagrees with this comment. The § 50.54(q) change process establishes a two factor test to establish whether the licensee has the authority to make a change without prior NRC approval. First, the plan as modified must continue to comply with the requirements of Appendix E, and for power reactors, the planning standards of § 50.47(b). Second, the licensee must establish that the change does not reduce the effectiveness of the emergency plan. These are two different prerequisites. Compliance with the requirements of Appendix E, and for power reactors, the planning standards of § 50.47(b), satisfies the first factor, but it doesn't necessarily meet the second factor.

Under § 50.47(a)(1)(i), an operating license will be issued only if the NRC finds that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. During the licensing process, the licensee or the NRC may have identified planning constraints and vulnerabilities that required the licensee to commit to site-specific capabilities and resources beyond those identified in generic regulatory guidance as meeting the requirements of Appendix E, and for

nuclear power reactor licensees, the planning standards of § 50.47(b). After receiving its license, a licensee may have identified newly developed planning or response constraints, or self-identified weaknesses in its emergency plan, and implemented corrective actions beyond that identified in its emergency plan. For example, an applicant having a site with complex meteorological regimes or complex topography may have been required to establish a more advanced emergency dose assessment capability. Because these extensions to generic guidance were found to be necessary to meet the broadly worded requirements in Appendix E, and for nuclear power reactor licensees, the planning standards of § 50.47(b), a licensee seeking to relax these requirements needs to determine that the emergency plan, as modified, can continue to be effective. This will generally require that the licensee establish that the considerations that made the site-specific requirements necessary are no longer applicable to that site, or require an alternative approach that maintains the plan's effectiveness. Thus, simply meeting the requirements of Appendix E, and for power reactors, the planning standards of § 50.47(b), is not necessarily sufficient to prevent a reduction in the plan's effectiveness. For these reasons, the requirements of Appendix E, and for power reactors, the planning standards of § 50.47(b), alone cannot be used for determining reductions in effectiveness.

Section 50.54(q)(1)(iv) in the final rule defines the term “reduction in effectiveness” as a change to the emergency plan that results in a reduction of the licensee's capability to perform an emergency planning function in the event of a radiological emergency. The phrase “reduction in effectiveness” is an evaluation concept that is used in § 50.54(q) to differentiate between changes that the licensee is allowed to make without prior NRC approval and those that require prior NRC approval. A determination that a change may result in a reduction in effectiveness does not imply that the licensee could no longer implement its plan and provide adequate measures for the protection of the public. The NRC may approve a proposed emergency plan change that the licensee determined to be a reduction in effectiveness if the NRC can find that the emergency plan, as modified, continues to meet the requirements of Appendix E, and for nuclear power reactor licensees, the planning standards of § 50.47(b), and continues to provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. “Radiological emergency” as used in § 50.54(q)(1)(iv) in the final rule means any condition that results in the declaration of any ECL and the implementation of the licensee's emergency plan. A nuclear power reactor licensee evaluating whether a particular emergency plan change constitutes a reduction in effectiveness is expected to consider the spectrum of accidents addressed in the planning basis described in NUREG-0654. In making this determination, licensees of non-power reactors and fuel facilities licensed under Part 50 must base their evaluations on the planning bases for their respective facilities.

In the proposed rule, § 50.54(q)(1)(iv) defined the term “reduction in effectiveness.” The NRC received a stakeholder comment that suggested that the definition of “reduction in effectiveness” should establish a threshold based on a “significant reduction” rather than a reduction. The comment cited, as an example, the use of “more than a minimal increase” in the § 50.59 change process. The NRC agrees that the § 50.59 change process does incorporate the phrase “more than a minimal amount.” However, this phrase is always used in conjunction with a numerical criterion (

e.g.,

§ 50.59(c)(2)(i) through (iv)). With few exceptions, the planning standards of § 50.47(b) and the requirements of Appendix E do not establish numerical requirements. Other criteria in § 50.59 are related to any change (

e.g.,

§ 50.59(c)(2)(v) through (vi) and (viii)). The NRC has determined that any change that reduces the effectiveness of the licensee's capability warrants prior NRC review; therefore, the NRC disagrees with the comment. The licensee is authorized to make changes without prior approval up to the point at which effectiveness is reduced. This standard is reflected in the final rule language.

Regulations in Parts 50 and 52 require applicants for licenses to develop emergency plans that meet the requirements of Appendix E, and for nuclear power reactors, § 50.47(b), as applicable, during facility licensing. A holder of a license under Part 50 or a combined license under Part 52 after the Commission makes the finding under § 52.103(g) is required by § 50.54(q)(2) in the final rule to follow and maintain the effectiveness of its emergency plan. The § 50.54(q)(2) references to Appendix E and § 50.47(b), as applicable, extend the applicability of these requirements as a condition of the facility license. The NRC expects licensees to identify conditions and situations that could reduce the effectiveness of its emergency plan, and to take corrective and/or compensatory actions to restore and maintain the requisite effectiveness.

In the proposed rule, § 50.54(q)(2) would have required licensees to follow and maintain the effectiveness of the emergency plan. The NRC received a stakeholder comment that stated that requiring a licensee to maintain an emergency plan effective under § 50.54(q)(2) is inconsistent with the NRC approving a change that reduces the effectiveness of the emergency plan as required by § 50.54(q)(4). Paragraphs (3) and (4) of § 50.54(q) address emergency plan changes that are intentional on the part of the licensee, whereas a non-compliance with § 50.54(q)(2) is generally the result of a licensee failure to follow the requirements of its emergency plan (

e.g.,

failure to notify OROs during an actual event) or failure to take action to address conditions, from whatever cause, that reduce the effectiveness of the emergency plan (

e.g.,

an offsite fire department identified and relied upon in the emergency plan is no longer available to come to the site, and the licensee hasn't taken timely corrective actions to restore the capability). The licensee's determination of a reduction in effectiveness is used only to determine whether the licensee has the authority to implement the change without prior NRC approval under § 50.54(q)(3) or must submit for prior NRC approval under § 50.54(q)(4). The NRC's approval of the proposed change establishes a new standard of effectiveness for the licensee's emergency plan. Accordingly, the NRC does not believe the final rule to be internally inconsistent.

Section 50.54(q)(3) in the final rule grants authority to the holder of a license to make changes to its emergency plan without prior NRC approval only if an analysis demonstrates that the changes do not reduce the effectiveness of the plan and the plan, as changed, continues to meet the requirements in Appendix E, and for nuclear power reactor licensees, § 50.47(b). As such, § 50.54(q)(3) provides for a two factor test to establish whether the licensee has the authority to make a change without prior NRC approval. First, the plan as modified must continue to comply with the requirements of Appendix E, and for power reactors, the planning standards of § 50.47(b). Second, the licensee must establish that the change does not reduce the effectiveness of the

emergency plan. These are two different and independent prerequisites. Compliance with the requirements of Appendix E, and for power reactors, the planning standards of § 50.47(b), addresses the first factor. The second factor addresses whether or not the change reduces the effectiveness of the emergency pan. A change that satisfies the first factor may not satisfy the second factor and vice versa. Changes that do not satisfy the first factor would require the licensee to request an exemption from the affected requirements under § 50.12. Changes that do not satisfy the second factor would require the licensee to request prior approval under § 50.54(q)(4).

The NRC expects a licensee considering a change under this section to perform an evaluation of the change to a level of rigor and thoroughness consistent with the scope of the proposed change. A licensee's analysis of the impact of a change on the effectiveness of the plan needs to consider the accidents included in the emergency planning basis, the licensing basis of the particular emergency plan, and any emergency plan elements implemented to address site-specific emergency response constraints (

e.g.,

delay in staff augmentation associated with a remote site, commitments to State or local governments, existence of significant external hazards, etc.).

Section 50.54(q)(4) in the final rule defines the process by which a licensee requests prior approval of a change to the emergency plan that the licensee has determined constitutes a reduction in effectiveness of the plan. The final rule retains the proposed requirement that a licensee pursuing these changes must apply for an amendment to its license as provided in § 50.90. A proposed emergency plan change that would reduce the effectiveness of the plan would expand the licensee's operating authority, and 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)). Therefore, a change to a licensee's emergency plan that would expand the licensee's operating authority should also be processed through the Commission's license amendment procedures.

In response to § 50.54(q)(4) in the proposed rule, the NRC received several comments questioning the NRC's conclusion that proposed changes that would reduce the effectiveness of the licensee's emergency plan would expand the licensee's operating authority. The NRC maintains that a reduction in the effectiveness of a licensee's emergency plan constitutes an expansion of the licensee's operating authority. A licensee's emergency plan is part of the licensing basis for its nuclear power plant. The plan describes how the licensee will comply with the NRC's requirements governing EP and emergency response. The NRC's regulations require that the licensee have and implement an approved emergency plan as a condition of its operating license. A change to the emergency plan constituting a reduction in effectiveness of that plan allows the licensee to disclaim responsibility for performing activities and actions (or specific portions thereof) formerly required (or prohibited) under the superseded provisions of the licensee's approved emergency plan. It allows the licensee to perform, without fear of NRC regulatory response (

e.g.,

an order, including an enforcement action), activities and actions formerly precluded. In this situation, the licensee would have the capability to operate its facility in a manner that was not previously authorized by the NRC. In other words, the licensee would have operating authority beyond what it originally had, as reflected in the approved emergency plan without the proposed change.

The NRC notes that it is not simply that the emergency plan has “changed” that leads to the conclusion that there is an expansion of operating authority. Otherwise, any change to the emergency plan, regardless of the effect on licensee authority to operate, would be deemed an expansion of operating authority for which NRC approval via a license amendment is required. Rather, the effect of the plan change (

i.e.,

allowing the licensee to operate in a manner with respect to radiological health and safety that it was not allowed to do under the superseded provision of the emergency plan) forms the essence of the test of “expanded” operating authority.

2

Thus, an emergency plan change that would reduce the effectiveness of the plan would expand the licensee's operating authority under its license.

2

Consistent with the former § 50.54(q), § 50.54(q) in the final rule requires that only those emergency plan changes that reduce the effectiveness of the plan need prior NRC approval. Those plan changes that increase the effectiveness of the plan may expand the licensee's operating authority but would not require prior NRC approval.

Moreover, the Commission has determined that the NRC must approve reductions in effectiveness to ensure compliance with the requirements of Appendix E, and for nuclear power reactors, the planning standards of § 50.47(b) so that the proposed changes provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. This approval is more than a ministerial, non-discretionary act. The determination of the acceptability of the proposed reduction in effectiveness necessitates consideration and resolution of technical and regulatory issues. In some instances, the evaluation of the plan change may involve the balancing of competing regulatory objectives and policies. Thus, NRC approval of a reduction in effectiveness constitutes an exercise of agency discretion. For these reasons, under the NRC's legal precedents, NRC approval of an emergency plan change that would reduce the effectiveness of the plan would grant the licensee greater operating authority and would require a license amendment request.

Under § 50.54(q)(4), in addition to satisfying the filing requirements for a license amendment request in §§ 50.90 and 50.91, the license amendment request must include all emergency plan pages affected by the change, a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the licensee's emergency plan, as revised, will continue to meet the requirements of Appendix E, and for nuclear power reactor licensees, the planning standards of § 50.47(b). The NRC will review the amendment application to make its no significant hazards consideration determination and to determine if the proposed change to the emergency plan is a reduction in effectiveness under § 50.54(q). If the proposed change does constitute a reduction in effectiveness, the NRC may issue the amendment only if it determines that the emergency plan, as modified, continues to meet the requirements in Appendix E, and for nuclear power reactors, the planning standards of § 50.47(b), and that there continues to be reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency.

Section 50.54(q)(5) in the final rule applies to all licensees subject to § 50.54(q) and requires that licensees retain a record of all changes to the emergency plan made without prior NRC approval for a period of three years from the date of change. This section also requires the licensee to submit, as specified under § 50.4, a report of each such change, including a summary description of its evaluation, within 30 days of the change being put into effect. The NRC expects that the record of changes will fully describe each change made and will include documentation of the evaluation that determined the change was not a reduction in effectiveness. The NRC will use this record of changes during inspection oversight of the licensee's implementation of § 50.54(q)(2).

In the proposed rule, § 50.54(q)(5) would have required licensees to submit a report of a change to the emergency plan made without NRC approval, 30 days after the change was made. One commenter requested that the 30-day period start when the “change is implemented” rather than starting when the “change is made.” The NRC agrees that clarification is necessary, but has decided to use the phrase “change is put into effect,” because it provides a more specific point in time. The change is put into effect when the modified emergency plan is available for use in the emergency response facilities. At that point, the change can affect the licensee's response to an emergency condition, whether or not all typical implementation activities, such as distribution of the updated emergency plan and ERO training, have been completed.

Section 50.54(q)(6) in the final rule requires a licensee of a nuclear power reactor to retain the emergency plan and each change for which prior NRC approval was obtained under § 50.54(q)(4) as a record until the Commission terminates the license.

The NRC is removing paragraph (r) of § 50.54. Section 50.54(r) was published as a final rule on August 19, 1980 (45 FR 55402), to require then-existing licensees authorized to possess and/or operate a research or test reactor facility to submit emergency plans complying with Appendix E to Part 50 to the NRC for approval within one year or two years, as applicable, from the effective date of the rule (November 3, 1980). (A discussion of this issue is also provided in Section II.B.6 of this document.)

The NRC is removing paragraph (s)(1) of § 50.54 to remove language addressing a one-time requirement that has now been completed. Section 50.54(s)(1) was published as a final rule on August 19, 1980 (45 FR 55402). This provision required existing nuclear power reactor licensees to submit to the NRC within 60 days after the effective date of the rule (November 3, 1980), the radiological response plans of State and local governmental entities in the U.S. that are wholly or partially within a plume exposure pathway EPZ, as well as the plans of State governments wholly or partially within an ingestion pathway EPZ. (A discussion of this issue is also provided in Section II.B.6 of this document.)

The NRC is removing paragraph (s)(2)(i) from § 50.54. Section 50.54(s)(2) was initially published as a final rule on August 19, 1980 (45 FR 55402), as a single paragraph. The rule was amended on May 29, 1981 (46 FR 28838), resulting in § 50.54(s)(2) being split into two paragraphs, §§ 50.54(s)(2)(i) and 50.54(s)(2)(ii). The rule language in § 50.54(s)(2)(i) required that the licensee, State, and local emergency plans for all operating power reactors be implemented by April 1, 1981, except as provided in Section IV.D.3. of Appendix E to Part 50. (A discussion of this issue is also provided in Section II.B.6 of this document.)

The NRC is removing paragraph (u) from § 50.54. Section 50.54(u) was published as a final rule on August 19, 1980 (45 FR 55402), to require then existing nuclear power reactor licensees to submit to the NRC plans for coping with emergencies that meet the standards in § 50.47(b) and the requirements of Appendix E to Part 50 within 60 days after the effective date of the rule (November 3, 1980). (A discussion of this issue is also provided in Section II.B.6 of this document.)

The NRC is revising paragraphs (gg)(1) and (gg)(2) of § 50.54 to replace “DHS” with “FEMA.” Although FEMA remains within DHS, the responsibility for offsite EP for nuclear power plants is with FEMA. The FEMA requested that “FEMA” be used rather than “DHS” for clarity of communication with stakeholders.

The NRC is amending § 50.54(gg)(1)(i) to remove the reference to the EOF as a “near-site” facility. The final rule provides criteria in Part 50, Appendix E, Section IV.E.8, regarding EOF distance from a nuclear power reactor site and for a performance based approach for EOFs, specifying that these facilities must meet certain functional requirements rather than requiring that they be located within a certain distance of the plant. The intent of this change is discussed in the section on changes to Appendix E, Section IV.E.8. (A discussion of this issue is also provided in Section II.B.3 of this document.)

3. Appendix E to Part 50, Emergency Planning and Preparedness for Production and Utilization Facilities

The NRC is amending Part 50, Appendix E, Section I, “Introduction,” to include a provision allowing an applicant for an early site permit under Part 52 that chooses to propose either major features of an, or a complete and integrated, emergency plan (§ 52.17(b)(2)), or a combined license under Part 52 (§ 52.79(a)(21)) whose application is docketed before December 23, 2011 to choose to defer compliance with this rule.

If the applicant chooses to defer compliance with this rule, and its early site permit or combined license is subsequently issued, then the permit holder or licensee shall request to amend its early site permit or combined license to demonstrate compliance with this rule no later than December 31, 2013. Furthermore, an applicant that defers compliance with this rule is expected to implement this rule under the same schedule as it would implement EP requirements in the absence of this rule. This means that this rule does not require any immediate implementation actions on the part of any applicant, but rather shall be implemented after receipt of a combined license, and under the licensee's schedule for completing EP-related requirements (

e.g.,

through completion of EP-related Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC)).

The NRC intends, by allowing an applicant to defer compliance with this rule, to avoid unnecessary delays in making a licensing decision on an early site permit or a combined license already under consideration by the NRC, provided:

(1) The application complies with all applicable, current (prior to this rulemaking) EP regulations;

(2) The applicant, if it becomes an early site permit holder or a combined licensee, requests to amend its early site permit or combined license before December 31, 2013, to comply with the amended EP regulations in this rule; and

(3) The applicant, if it becomes an early site permit holder or a combined licensee, may not operate the facility until the NRC has approved the license amendment demonstrating compliance with this rule.

In response to a request in the proposed rule for comments on the potential impacts of a final rule on combined license and early site permit application processes and schedules, the NRC received comments that the

NRC should not require pending combined license and early site permit applicants to implement the final rule changes until after the NRC issues the license or permit. In this final rule, the NRC is offering applicants the option to defer

compliance

with the final rule. That period of compliance deferral, between December 23, 2011 and December 31, 2013, was selected specifically to apply only to those applications that have already been docketed and are nearing completion of the safety review and subsequent hearings (as applicable) prior to a licensing decision being made on the application. The NRC decided to limit the duration of that deferral as stated because future applicants and currently docketed applicants not nearing a licensing decision would have ample time to bring their applications into compliance with this final rule without the need to defer compliance. So that all combined license and early site permit applicants ultimately comply with the same regulations, an applicant whose application is docketed before December 23, 2011 that does not receive a combined license or early site permit before December 31, 2013, shall revise its combined license or early site permit application to comply with the changes in this final rule no later than December 31, 2013.

The NRC has added a new requirement in Part 50, Appendix E, Section I, to address the Tennessee Valley Authority (TVA) facility at Watts Bar. The TVA is in possession of a current construction permit for Watts Bar Nuclear Plant, Unit 2, and is treated as a current licensee for purposes of satisfying the requirements of this rule. These requirements reflect NRC support of a licensing review approach for Watts Bar Nuclear Plant, Unit 2, that employs the current licensing basis for Unit 1 as the reference basis for review and licensing of Unit 2, as stated in the SRM to SECY-07-0009, “Possible Reactivation of Construction and Licensing Activities for the Watts Bar Nuclear Plant Unit 2,” dated July 25, 2007.

To improve clarity in the organization of the regulations, the final rule numbers the paragraphs of Section I.

The NRC is amending paragraph H in Section II of Appendix E to remove a reference to the EOF as a “near-site” facility. Criteria are provided in Section IV.E.8, of Appendix E, regarding EOF distance from a nuclear power reactor site and for a performance based approach for EOFs. The criteria specify that these facilities need to meet certain functional requirements rather than requiring that they be located within a certain distance of the plant. The intent of this change is discussed in the changes to Section IV.E.8, of Appendix E. (A discussion of this issue is also provided in Section II.B.3 of this document.)

The NRC is amending several paragraphs within Section IV of Appendix E to Part 50 that apply to licensees and applicants for licenses under Part 50 or Part 52 of this chapter, as applicable. All provisions of Section IV of Appendix E to Part 50 apply to applicants for, and holders of, nuclear power reactor operating licenses under Part 50, combined licenses under Part 52, and certain early site permits under Part 52. Many of the provisions in Section IV also apply to Part 50 non-power reactor licensees. Therefore, for purposes of brevity, the initial reference to a “licensee” in each of the remaining paragraphs in this section indicates that that particular rule change applies to applicants for, and holders of, operating licenses under Part 50 for nuclear power reactors and non-power reactors, combined licenses under Part 52, and certain early site permits under Part 52, unless specifically stated otherwise. The initial reference to “nuclear power reactor licensee” in each of the remaining paragraphs in this section means applicants for, and holders of, operating licenses for nuclear power reactors under Part 50, combined licenses under Part 52, and certain early site permits under Part 52, unless specifically stated otherwise.

The NRC is amending the former first paragraph of Section IV by adding language to require nuclear power reactor licensees, but not applicants, to revise their ETEs when the U.S. Census Bureau decennial census data is available. The final rule requires that within 365 days of the later of the date of the availability of the most recent decennial census data or the effective date of this final rule, and within 365 days of the availability of subsequent decennial census data, these licensees must revise their ETE analyses using the decennial census data, and submit the analyses to the NRC under § 50.4.

The NRC will review the ETE analyses for completeness using NUREG/CR-7002, “Criteria for Development of Evacuation Time Estimate Studies,” the NRC guidance on ETE development issued with the final rule. The NRC received comments regarding the timeliness of submitting ETE updates for NRC review and extended the time period for ETE update submission from 180 to 365 days after a population change triggering the update or the release of census data. The NRC will not approve ETE updates but will review them for completeness. For this reason the NRC is requiring licensees to submit their ETE updates at least 180 days before they use them to form protective action recommendations and provide them to offsite authorities for use in developing offsite protective action strategies. This will allow time for NRC review after which licensees may assume that the updates are adequate and available for use.

The NUREG/CR-7002 guidance is an acceptable template to meet the requirements for ETE analysis development and nuclear power reactor licensees should use this guidance, or an appropriate alternative, when developing an ETE analysis or analysis update. The first set of 2010 census data is expected to be available in 2011. The NRC will establish a schedule for review of the updated ETEs. After the licensee submits the ETE analysis for NRC review, these ETEs will be known as the licensee's “updated” ETEs, as opposed to the “approved” ETEs, which are the ETEs approved by the NRC when it issues a license.

Thereafter, these licensees are required to annually review changes in the population of their EPZs. To complete these reviews, licensees will use data from the U.S. Census Bureau, which annually produces resident population estimates and State/local government population data, if available. These reviews must be conducted no more than 365 days apart. The licensee is required to update the ETE analysis to reflect the impact of a population change that causes the longest ETE value for the 2-mile zone or 5-mile zone, including all affected Emergency Response Planning Areas (ERPAs), or for the entire 10-mile EPZ to change by 25 percent or 30 minutes, whichever is less from the licensee's currently NRC-approved or updated ETE. An ERPA is defined as a local area within the EPZ for which emergency response information is provided; the EPZ is typically divided into ERPAs along geographic or political boundaries. The licensee is required to submit the updated ETE analysis to the NRC under the procedures of § 50.4 within 365 days of the availability of the population data used in the update and at least 180 days before using it to form protective action recommendations and providing it to State and local governmental authorities for use in developing offsite protective action strategies.

In the proposed rule, the NRC would have required an ETE analysis update when the population in the EPZ or most populous ERPA increased or decreased by more than 10 percent from the

population that formed the basis for the licensee's currently approved ETE. Several commenters disagreed with the 10 percent population change criterion being the triggering event that would require licensees to update their ETEs. Suggested alternative thresholds included various population sensitivity studies that would assess the effects of population changes on ETE values; a 25 percent change in the ETE baseline rather than a 10 percent change in the EPZ population; and population changes resulting in a change to ETE values of 25 percent or 30 minutes, whichever is less.

The final rule adopts the approach of a 25 percent or 30 minute increase in ETE values to determine when an ETE analysis update is warranted. The NRC determined that basing ETE analysis updates on a population change alone without consideration of its impact on the ETE values may not have resulted in useful ETE updates. This is because a large population change in an area where there is an established infrastructure may have no impact on ETE values, whereas a small population change in an area with limited infrastructure may impact the ETE values. The proposed requirement to update an ETE analysis based on a standard value of a 10 percent population change would have required licensees to submit updated ETEs that may have had the same time estimates as the original document and, therefore, would provide no useful updated ETE information to response agencies. An approach that considers both population change and its impact on the ETE numerical values provides assurance that updated ETE analyses are submitted only when the ETE values are impacted. This links the update to a population change that has an impact on the ETE values on a site-specific basis rather than a generic 10 percent population change that may or may not impact these values.

Therefore, nuclear power reactor licensees (but not applicants) will be required to provide an updated ETE analysis to the NRC within 365 days of (1) The later of the date of the availability of the most recent decennial census data or the effective date of this final rule, (2) the availability of subsequent decennial census data, and (3) the availability of the population data used in the update, during the years between decennial censuses, when a population increase within the EPZ causes certain ETE values to increase by 25 percent or 30 minutes, whichever is less from the licensee's currently NRC-approved or updated ETE. Licensees should perform a population sensitivity study for various population increases (

i.e.,

10 percent, 20 percent, and 30 percent increases) to determine the population value that will cause ETE values to increase by 25 percent or 30 minutes, whichever is less. If this threshold is reached during the decennial period between censuses, the licensee must update the ETE analysis to reflect the impact of the population increase. To establish the basis for these update criteria, the NRC considered the input of ETE subject matter experts who considered the sensitivity of ETE analysis tools, uncertainty of the data used in the development of ETEs, and discussions with OROs regarding the time necessary to mobilize resources to support an evacuation. The NRC determined that an ETE increase of 30 minutes is the smallest time value that OROs would consider to potentially impact a protective action decision from shelter-in-place to evacuate or vice versa. A review of more than 30 current ETEs shows that most ETEs are longer than 4 hours. Therefore, the 30-minute increase would likely be the overriding criterion, although the 25-percent increase would be expected to apply primarily to sites with shorter ETEs. Either of these criteria would constitute a material change in ETE times and would provide an appropriate assessment of the effect of population change on the ETE on a site-specific basis.

In the proposed rule, the NRC would have required the licensee to submit an ETE update within 180 days of a population change triggering the update or the release of census data. The NRC received several stakeholder comments in opposition to the proposed 180-day requirement, some stating that the 180-day timeframe may be unrealistic. The NRC agrees that 180 days to complete ETE updates could be challenging based on the number of licensees and the limited number of commercial contractors available to complete the updates. Therefore, the NRC is extending the amount of time to complete ETE analysis updates from 180 to 365 days.

One commenter pointed out that ETEs only analyze the time required to evacuate areas within the EPZ. The commenter requested that the NRC clarify the sentence “time required * * *

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