Proposed Generic Communication; NRC Regulatory Issue Summary 2005-02, Revision 1, Clarifying the Process for Making Emergency Plan Changes, 42699-42703 [E9-20334]

Download as PDF Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices ehd.nrc.gov/EHD_Proceeding/home.asp, unless excluded pursuant to an order of the Commission, an Atomic Safety and Licensing Board, or a Presiding Officer. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or home phone numbers in their filings. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their works. Dated this 14th day of August 2009. For the Nuclear Regulatory Commission. Cynthia A. Carpenter, Director, Office of Enforcement. [FR Doc. E9–20333 Filed 8–21–09; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2009–0365] Proposed Generic Communication; NRC Regulatory Issue Summary 2005– 02, Revision 1, Clarifying the Process for Making Emergency Plan Changes erowe on DSK5CLS3C1PROD with NOTICES AGENCY: Nuclear Regulatory Commission. ACTION: Notice of opportunity for public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to issue a regulatory issue summary (RIS) to clarify the process for making emergency plan changes. This FRN version of the draft Regulatory Issue Summary (RIS) does not include the Attachments and Enclosures as described in the body of the RIS. To view these attachments and enclosures, refer to the NRC’s Agencywide Documents Access and Management System (ADAMS), document number ML080710029. The NRC’s internal nonconcurrence process ‘‘Draft Management Directive 10.158, ‘NRC NonConcurrence Process’,’’ has been invoked by a member of the NRC staff regarding draft RIS 2005–01, Revision 1. The non-concurrence and supporting information is publically available through ADAMS Accession No. ML092250622. DATES: Comment period expires October 8, 2009. Comments submitted after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except for comments received on or before this date. ADDRESSES: You may submit comments by any one of the following methods. VerDate Nov<24>2008 15:04 Aug 21, 2009 Jkt 217001 Please include Docket ID NRC–2009– 0365 in the subject line of your comments. Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site Regulations.gov. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed. Federal Rulemaking Web site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC–2009–0365. Address questions about NRC dockets to Carol Gallagher at 301–492–3668; e-mail Carol.Gallagher@nrc.gov. Mail comments to: Michael T. Lesar, Chief, Rulemaking and Directives Branch (RDB), Division of Administrative Services, Office of Administration, Mail Stop: TWB–05– B01M, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001, or by fax to RDB at (301) 492– 3446. FOR FURTHER INFORMATION CONTACT: Don A. Johnson at 301–415–4040 or by e-mail at don.johnson@nrc.gov. SUPPLEMENTARY INFORMATION: NRC Regulatory Issue Summary 2005– 02, Revision 1; Clarifying the Process for Making Emergency Plan Changes Addressees All holders of licenses for nuclear power reactors under the provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part 50, ‘‘Domestic Licensing of Production and Utilization Facilities,’’ including those that have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel. All holders of licenses for research and test reactors under Part 50. All holders of and applicants for nuclear power plant construction permits, early site permits and limited work authorizations under Part 50. All holders of a combined license for a nuclear power plant under the provisions of 10 CFR part 52, ‘‘Licenses, PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 42699 Certifications, and Approvals for Nuclear Power Plants.’’ All holders of licenses for fuel facilities under the provisions of 10 CFR part 40 ‘‘Domestic Licensing of Source Material’’ required to have an emergency plan under § 40.31(j)(1)(ii). All holders of licenses for fuel facilities under the provisions of 10 CFR part 70 ‘‘Domestic Licensing of Special Nuclear Material’’ required to have an emergency plan under § 70.22(i)(1)(ii). All holders of certifications for gaseous diffusion plants under the provisions of 10 CFR part 76 ‘‘Certification of Gaseous Diffusion Plants’’ required to have an emergency plan under § 76.35(f). All holders of site-specific licenses for Independent Spent Fuel Storage Installations under 10 CFR part 72 ‘‘Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste.’’ Intent The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS) revision to inform stakeholders that reactor emergency plan changes that require prior NRC approval, in accordance with 10 CFR 50.54(q), will need to be submitted as license amendment requests in accordance with 10 CFR 50.90, ‘‘Application for Amendment of License, Construction permit, or Early Site Permit.’’ In addition, this revision will (1) clarify the meaning of ‘‘decrease in effectiveness’’, as stated in 10 CFR 50.54(q); (2) clarify the process for evaluating proposed changes to emergency plans; (3) provide a method for evaluating proposed changes to emergency plans; (4) provide clarifying guidance on the appropriate content and format of applications submitted to the NRC for approval prior to implementation; and (5) clarify what constitutes a report of emergency plan changes to be submitted to the NRC in accordance with 10 CFR 50.54(q). This revision supersedes RIS 2005–02, dated February 14, 2005, in its entirety due to the extent of changes. (1) For non-reactor facilities, the regulations in 10 CFR 40.35(f), 70.32(i), and 76.91(o) provide direction to licensees seeking to revise their emergency plan. An emergency plan includes the plan as originally approved by the NRC and all subsequent changes made by the licensee with, and without, prior NRC review and approval under these regulations. The current practice for non-reactor facilities concerning emergency plan changes that require E:\FR\FM\24AUN1.SGM 24AUN1 42700 Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices erowe on DSK5CLS3C1PROD with NOTICES prior NRC approval is to submit the changes as a license amendment request. Current regulatory guidance for non-reactor emergency plans is contained within Regulatory Guide 3.67, ‘‘Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities.’’ The NRC staff is working on updating Regulatory Guide 3.67 to include applicable elements of this RIS for fuel cycle facilities. The NRC will publish a Federal Register Notice of the issuance for public comment and availability of the draft updated Regulatory Guide. (2) For Independent Spent Fuel Storage Installations (ISFSI), the emergency plan change process should be followed in accordance with 10 CFR 72.44(f). The information in this RIS provides useful examples of the type of evaluations NRC expects ISFSI licensees to conduct in reviewing changes to their Part 72 approved emergency plans (refer to § 72.24(k) and § 72.32) and determining if the changes may be made without prior NRC approval as required by § 72.44(f). The current practice for non-reactor facilities concerning emergency plan changes that require prior NRC approval is to submit the changes as a license amendment request. Additional guidance on emergency planning for ISFSI licensees is provided in Spent Fuel Storage and Transportation Interim Staff Guidance— 16, ‘‘Emergency Planning.’’ This RIS revision requires no action or written response on the part of addressees. Background Information The regulation in 10 CFR 50.54(q) provides direction to licensees seeking to revise their emergency plan. The requirements related to nuclear power plant emergency plans are given in the standards in 10 CFR 50.47, ‘‘Emergency Plans,’’ and the requirements of Appendix E, ‘‘Emergency Planning and Preparedness for Production and Utilization Facilities’’ to 10 CFR Part 50. The standards in § 50.54(q) and Appendix E to Part 50 also establish the requirements related to emergency plans for research and test reactors. Based upon feedback from the nuclear power industry, the research and test reactor community, and experience gained by the NRC staff after reviewing emergency plan changes, the NRC staff has identified a need to clarify the process for making changes to an emergency plan and to provide licensees with a consistent method for evaluating proposed emergency plan changes. In addition, the NRC staff clarifies herein that the license amendment process is the correct process to use VerDate Nov<24>2008 15:04 Aug 21, 2009 Jkt 217001 when reviewing decrease (reduction) in effectiveness submittals. Courts have found that Commission actions that expand licensees’ authority under their licenses without formally amending the licenses constitute license amendments and should be processed through the Commission’s license amendment procedures. See Citizens Awareness Network, Inc. v. NRC, 59 F.3d 284 (1st Cir. 1995); Sholly v. NRC, 651 F.2d 780 (D.C. Cir. 1980) (per curiam), vacated on other grounds, 459 U.S. 1194 (1983); and In re Three Mile Island Alert, 771 F.2d 720, 729 (3rd Cir. 1985), cert. denied, 475 U.S. 1082 (1986). See also Cleveland Electric Illuminating Co. (Perry Nuclear Power Plant, Unit 1), CLI–96–13, 44 NRC 315 (1996). A proposed emergency plan change that would reduce the effectiveness of the plan would give the licensee a capability to operate at a level of effectiveness that was not previously authorized by the NRC. In this situation, the licensee’s operating authority would be expanded beyond the authority granted by the NRC as reflected in the emergency plan without the proposed change. Thus, an emergency plan change that would reduce the effectiveness of the plan would expand the licensee’s operating authority under its license. A change expanding the licensee’s operating authority is, according to the courts, a license amendment and must be accomplished through a license amendment process. The staff also stated in SECY–08– 0024, ‘‘Delegation of Commission Authority to Staff to Approve or Deny Emergency Plan Changes that Represent a Decrease in Effectiveness,’’ dated February 25, 2008, ‘‘To make the process by which the NRC will address proposed 10 CFR 50.54(q) changes that represent a decrease in effectiveness clearer, the staff intends to incorporate language similar to that which currently exists in 10 CFR 50.54(p)(1), as part of the planned rulemaking.’’ The current schedule for the staff’s emergency preparedness (EP) rulemaking calls for the final rule to be issued no earlier than the summer of 2010. Because of the timeframe associated with the rulemaking, the staff has determined that the prudent action is to issue a RIS to clarify that licensees must submit proposed emergency plan changes which represent a decrease in effectiveness for NRC approval as specified in § 50.54(q), and the license amendment process is the correct process for the staff to use in reviewing the proposed change. For purposes of discussion and to incorporate the possibility of future regulatory changes, PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 the term ‘‘decrease in effectiveness’’ is considered synonymous with ‘‘reduction in effectiveness (RIE).’’ Summary of Issue Licensees routinely evaluate proposed revisions to their emergency plan, to determine if these changes reduce the effectiveness of their current approved emergency plan or adversely affect their ability to implement the emergency plan. Clarification is needed of an acceptable method for licensees to use in consistently evaluating proposed changes to the emergency plan to ensure the licensee’s ability to maintain and implement the approved emergency plan. Additionally, licensees should understand the process for submitting proposed emergency plan changes to the NRC for approval prior to implementation when there is a determination of a decrease (reduction) in effectiveness. The change process is described below and clarified by providing a screening criterion that would ensure consistency of emergency plan change determinations of a decrease (reduction) in effectiveness. Enclosure 1, ‘‘10 CFR 50.54(q) Evaluation Procedure,’’ presents a suggested outline for applying the screening criteria for the evaluation of a proposed emergency plan change, which is graphically depicted in Attachment 1 to Enclosure 1, ‘‘10 CFR 50.54(q) Flowchart.’’ In addition, Enclosure 2, ‘‘Guidance for Content of Emergency Plan Submittals to NRC Requiring Prior NRC Approval,’’ provides guidance to licensees in the development of their application for NRC prior approval of proposed emergency plan changes. The information in this RIS revision clarifies the process for changing emergency plans to ensure that licensees maintain effective emergency plans thereby maintaining reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. This RIS revision also provides a consistent methodology for licensees to evaluate changes to their emergency plans and provides clarifying guidance for the development of applications for NRC prior approval. This will help ensure that NRC review activities and decisions are effective, efficient, predictable, and consistent. The regulations require licensees to submit a report of each change within a specified period of time after the change is made. The NRC Inspectors use this report to evaluate the effectiveness of a licensee’s emergency plan change management program in accordance with NRC Inspection Procedures, and E:\FR\FM\24AUN1.SGM 24AUN1 Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices although not required, the inclusion of the applicable licensee evaluation and justification for the change as part of this report would be beneficial to the staff. Regulation In part, 10 CFR 50.54(q) states the following: The nuclear power reactor licensee may make changes to these plans without Commission approval only if the changes do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the standards of § 50.47(b) and the requirements of appendix E to this part. The research reactor and/or the fuel facility licensee may make changes to these plans without Commission approval only if these changes do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the requirements of appendix E to this part* * *. Proposed changes that decrease the effectiveness of the approved emergency plans may not be implemented without application to and approval by the Commission. erowe on DSK5CLS3C1PROD with NOTICES Definitions (1) Decrease (Reduction) in Effectiveness (RIE) (a) A change in an emergency plan that results in reducing the licensee’s capability to perform an emergency planning function in the event of a radiological emergency. (i) Note that other licensee activities could affect the ability to implement the emergency plan effectively. Licensees must maintain the effectiveness of their NRC approved emergency plans, up to and including ensuring that changes made to other programs, structures, systems or components do not adversely impact the licensee’s ability to effectively implement its emergency plan. See Information Notice 2005–19, ‘‘Effect of Plant Configuration Changes on the Emergency Plan,’’ dated July 18, 2005, for additional information. (1) An RIE will occur if there is a change or reduction in an emergency planning function without a commensurate reduction or change in the bases for that emergency planning function or without measures put in place to reduce the impact of the proposed change to the emergency plan. The overall impact of proposed changes on the effectiveness of the emergency plan or its implementation is to be determined, not just the effect that individual changes have on a specific part of the emergency plan. (2) The following provides some examples of RIEs that would require prior NRC approval without a commensurate reduction or change in the bases for that emergency planning function or without measures put in VerDate Nov<24>2008 15:04 Aug 21, 2009 Jkt 217001 place to reduce the impact of the proposed change to the emergency plan. These examples should not be viewed as being all-inclusive or exclusive; rather, licensees should use them to inform decisions involving various changes being considered. It is also possible that site-specific situations may make a particular example inapplicable to a site. Even if a particular example completely encompasses the change being considered, the licensee’s emergency plan change evaluation should explain why the site-specific implementation of the change would not be an RIE for that particular site. It is not sufficient for such an analysis to simply cross-reference an example in this RIS revision. (a) A change that would cause any of the major functional areas or major tasks identified in the emergency plans to be unassigned. An example of this would be a technical specification change eliminating on-shift radiation technician coverage without making an alternative arrangement for providing the requisite technical expertise in a timely manner. (b) A change that would impede site access for offsite assistance relied on in the plan without viable alternate arrangements being made. An example would be the closure or planned closure of a major river bridge in a case where the route via the nearest available crossing would incur a substantial increase in response time. (c) A change to the emergency response organization (ERO) callout procedures or hardware that would delay ERO notification such that the augmentation times in the emergency plans can no longer be achieved. A change to communications hardware that would reduce the capability to initiate and complete required emergency notifications within 15 minutes of the emergency declaration. (d) A change to the onsite meteorological measurements program such that meteorological data currently readily available in emergency response facilities in accordance with the emergency plan would no longer be readily available. (e) A change to hazard assessment and radiation protection assignments in reentry and recovery procedures that would not provide an adequate level of personal protection in uncertain reentry conditions. (f) A change that reduces the availability of site familiarization training currently presented to offsite assistance groups (e.g., firefighters, local law enforcement, and medical services, including mutual aid companies that would support these groups). PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 42701 (g) A change that delegates the responsibility for performance of various aspects of emergency plan maintenance to contractors or other external groups without adequate supervisory oversight to ensure that program elements continue to be met (e.g., a change delegating testing and maintenance of the Alert and Notification System to an external group not subject to typical nuclear facility work process and configuration controls). (3) For proposed changes to individual emergency action levels (EALs) (i.e., not an entire EAL scheme change), an RIE will occur in the following cases: (a) The proposed change to the EAL would potentially cause an underclassification (e.g., what was considered an Alert in the approved emergency plan would now be considered an Unusual Event or not classified at all). (b) The proposed change to the EAL would potentially cause an overclassification (e.g., what was considered a Site Area Emergency in the approved emergency plan would now be considered a General Emergency with potential consequences for public health and safety). (c) If the proposed change to the EAL is to change an Initiating Condition setpoint (or threshold) without a commensurate change in the regulatory basis for the EAL Initiating Condition setpoint (or threshold). (d) The actual numerical setpoint of a given EAL may be revised without prior NRC approval under the following conditions via the 10 CFR 50.54(q) emergency plan change process: (i) The regulatory basis for the EAL setpoint has been revised and is approved via a letter to the licensee or a Safety Evaluation (SE). For example, a site receives NRC approval (via a SE) for power up-rate. Power up-rate implementation causes the ‘‘normal’’ radiation levels to increase, thus necessitating an increase in EAL setpoints based on ‘‘normal’’ radiation levels. The regulatory basis for the setpoint has been changed, thus this change can be processed via the emergency plan change process because the effectiveness of the emergency plan has not been reduced. (ii) The regulatory basis for the EAL setpoint has not been changed but the method for detection of the setpoint has been changed. For example, a given EAL setpoint is based upon exceeding 1 Rem total effective dose equivalent (TEDE). The radiation monitor reading setpoint is based upon a reading that would give the equivalent of exceeding 1 Rem E:\FR\FM\24AUN1.SGM 24AUN1 42702 Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices TEDE. The radiation monitor is replaced and operates differently. The actual numerical value of the EAL needs to be revised to that which is equivalent to 1 Rem TEDE. The regulatory basis for the setpoint has not been changed, thus this change can be processed via the emergency plan change process as the effectiveness of the emergency plan has not been reduced. (2) Emergency plan (a) The document(s) prepared and maintained by the licensee that identify and describe the licensee’s methods for maintaining and performing emergency planning functions. An emergency plan includes the plans as originally approved by the NRC and all subsequent changes made by the licensee with, and without, prior NRC review and approval under 10 CFR 50.54(q). (i) The licensee’s emergency plan consists of: (1) The emergency plan as approved by the NRC via a Safety Evaluation Report, SE, or license amendment (LA) from the Office of Nuclear Reactor Regulation (NRR) or the Office of Federal and State Materials and Environmental Management Programs (FSME). (2) Changes to the emergency plan explicitly reviewed by the NRC through an SE, or LA from NRR or FSME, and found to meet the applicable regulations. (3) Changes to the emergency plan explicitly reviewed by the NRC through an SE, or LA, and found to be an approved amendment to the licensee’s emergency plan. (4) Changes made by the licensee without NRC review and approval after the licensee concluded that the change(s) do not constitute a RIE. Emergency Plan Change Process erowe on DSK5CLS3C1PROD with NOTICES 1. Process Overview Reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency is based on the licensee’s emergency plan, and the successful implementation of that emergency plan. The body of an emergency plan contains statements that describe how a licensee will meet regulatory requirements. The standards of 10 CFR 50.47(b) and the requirements of Appendix E to 10 CFR part 50 establish the contents of the nuclear power reactor emergency plan. The standards in § 50.54(q) and Appendix E to Part 50 establish the requirements related to emergency plans for research and test reactors. Subsequent changes to the emergency plan must comply with § 50.54(q). VerDate Nov<24>2008 15:04 Aug 21, 2009 Jkt 217001 Enclosure 1 outlines the emergency plan change process, and Attachment 1 to Enclosure 1 graphically depicts the process in a flowchart. 2. Emergency Plan Review Changes to an emergency plan may result from advances in technology, new or revised rules, site-specific needs, processes, guidance (such as Nuclear Energy Institute guidance endorsed by the NRC), technical specification changes, or modifications to instrumentation. Changes that the licensee has identified as RIEs must be submitted to the NRC for review and prior approval. The NRC staff will review the emergency plan change against the standards, regulations, guidance documents and the approved emergency plan. The NRC will review and approve submittals on a case-bycase basis. An emergency plan change approved for one licensee does not mean that the same or similar change would be approved for another licensee. For the purposes of determining whether a change to a licensee’s emergency plan constitutes an RIE, the licensee should use the last emergency plan reviewed and approved by the NRC. If the emergency plan change process has been properly implemented over the years, comparing a proposed emergency plan change to either the latest emergency plan reviewed and approved by the NRC or the emergency plan as changed by the licensee should result in the same RIE determination. For example, if a licensee made a series of changes over time to the same specific provision of the emergency plan, where each change was separately determined not to constitute an RIE, then there should be no RIE. Therefore, there should be no RIE when comparing the latest emergency plan to the emergency plan reviewed and approved by the NRC. If a licensee or the NRC concludes that there is a RIE due to a series of changes over time, then the provisions of the emergency plan change process have not been correctly followed. The EP requirements are a framework for how the licensee will meet the applicable standards and requirements of the regulations. If a licensee has determined that an EP requirement should be increased in order to meet the planning standards or Appendix E to Part 50 requirements, these changes must follow the emergency plan change process and revise the emergency plan to reflect this increase to the EP requirement. Nevertheless, whether or not an emergency plan change results in a RIE is not determined by assessing whether NRC regulatory requirements PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 continue to be met after the EP requirement has been changed. The licensee’s emergency plan may include EP requirements that exceed the baseline standards and requirements as set forth in § 50.47(b) and Appendix E to Part 50. For the RIE determination, the change or changes should be evaluated against the capability to perform the functions and the associated time requirement of performing the function, if applicable. The evaluation should document whether the capability or timeliness to perform a function is lost and/or degraded. In addition to the RIE determination, the change or changes should also be evaluated to verify that they continue to meet the standards and requirements as set forth in § 50.47(b) and Appendix E to Part 50. The current Commission requirements for document retention in § 50.54(q), specify that changes that do not warrant NRC approval must be retained for 3 years. The licensee must retain changes that reduce the effectiveness of the emergency plan until the Commission terminates the license. It may be prudent to save emergency plan change documentation to show the historical progression of changes, since the Commission, through its staff, may review at any time, the emergency plan changes that have been made. Related Topics Regarding Emergency Plan Changes 1. Regulatory Process for Evaluating Licensee Requests for NRC Prior Approval of Emergency Plan Changes Determined To Be a RIE in Accordance With 10 CFR 50.54(q) Similar to security plan changes submitted via 10 CFR 50.54(p)(1), emergency plan changes that result in the reduction in the effectiveness of the approved emergency plan require prior NRC approval, under § 50.54(q), and should to be submitted as license amendment requests under § 50.90. 2. Emergency Action Level Changes A revision to an entire EAL scheme, from NUREG–0654, ‘‘Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants,’’ to another NRCendorsed EAL scheme, must be submitted for prior NRC approval as specified in Section IV.B. of Appendix E to 10 CFR Part 50. The Statement of Considerations for the final rule amending the NRC’s regulations relating to NRC approval of EAL changes, dated January 26, 2005, stated in part, ‘‘The E:\FR\FM\24AUN1.SGM 24AUN1 Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices erowe on DSK5CLS3C1PROD with NOTICES Commission believes a licensee’s proposal to convert from one EAL scheme (e.g., NUREG–0654-based) to another EAL Scheme (NUMARC/NESP– 007 or NEI 99–01 based) * * * is of sufficient significance to require prior NRC review and approval. NRC review and approval for such major changes in EAL methodology is necessary to ensure that there is reasonable assurance that the final EAL change will provide an acceptable level of safety.’’ Regulatory Guide 1.101, Revisions 3 and 4, ‘‘Emergency Planning and Preparedness for Nuclear Power Reactor,’’ endorsed NUMARC/NESP–007 and NEI 99–01 EAL guidance, respectively, as acceptable alternatives to the guidance provided in NUREG–0654 for development of EALs to comply with § 50.47 and Appendix E to Part 50. A change in an EAL scheme to incorporate the improvements provided in NUMARC/NESP–007 or NEI 99–01 would not decrease the overall effectiveness of the emergency plan and would not expand a licensee’s operating authority beyond that previously authorized by NRC, but due to the potential safety significance of the change, the change needs prior NRC review and approval. This approval is given via SE and letter. Revisions of an individual EAL that results in a decrease in effectiveness must be submitted for NRC approval as specified in § 50.54(q), and the license amendment process is the correct process for the staff to use in reviewing the proposed change. As discussed previously, an emergency plan change that would reduce the effectiveness of the plan would expand the licensee’s operating authority under its license. A change expanding the licensee’s authority is, according to the courts, a license amendment and must be accomplished through a license amendment process. For research and test reactors, NUREG–0849, ‘‘Standard Review Plan for the Review and Evaluation of Emergency Plans for Research and Test Reactors,’’ issued October 1983, provides guidance on EALs and how changes should be made on a case-by-case basis with consideration of the provisions of § 50.54(q). 3. Inspection Activities For power reactors, the NRC inspectors use Inspection Procedure (IP) 71114.04 to conduct a review of the effectiveness of the licensee’s implementation of the 10 CFR 50.54(q) change process. For research and test reactors, the NRC inspectors use IP 69011, ‘‘Class I Research and Test Reactor Emergency Preparedness,’’ and VerDate Nov<24>2008 15:04 Aug 21, 2009 Jkt 217001 42703 IP 69001, ‘‘Class II Research and Test Reactors.’’ The inspector will perform a screening review of the change relative to the emergency plan; however, this will not constitute NRC approval of the plan as changed. The documentation of the change reviewed by the inspectors will be the report provided by the licensee as stated in § 50.54(q). Although not required, the inclusion of the applicable licensee evaluation and justification for the change as part of this report would assist the staff in the review. conditions. In 10 CFR 50.54(q), a licensee requests Commission authority to do what is not currently permitted under its license. The licensee has no valid expectations protected by the Backfit Rule regarding the means for obtaining the new authority that is not permitted under the current license. For these reasons, this RIS revision does not constitute a backfit under 10 CFR 50.109, and the staff did not perform a backfit analysis. 4. Lower Tier Documents If a licensee has incorporated a lower tier document into the emergency plan or the emergency plan explicitly references a lower tier document as a method to implement a specific requirement in the emergency plan, then, it is considered part of the plan and subject to § 50.54(q) review. Historically, some licensees have developed emergency plan implementing procedures that included the necessary information needed for activities that are required to meet the regulations, for example, procedures for notifications, dose assessment, protective action recommendations, emergency classifications and emergency action levels. The staff is not making the use of § 50.54(q) to review all changes to lower tier documents a requirement, but acknowledges that using § 50.54(q) as the regulation to provide revision control of these lower tier documents has been in place and supported by the NRC through the inspection and licensing process. To be done after the public comments periods. Backfit Discussion This RIS revision does not require any action or written response. This RIS revision provides non-regulatory review guidance for licensees and clarifies existing regulatory requirements licensees must follow when proposing changes to their emergency plans. The NRC’s Backfit Rule, 10 CFR 50.109, applies to, among other things, the procedures necessary to operate a nuclear power plant. To the extent that using a license amendment process for making modifications to emergency plans that reduce the effectiveness of the plans is considered a change, it would be a change to the NRC’s regulatory process for addressing modifications to the emergency plan. The NRC’s regulatory review process is not a licensee procedure required for operating a plant that would be subject to backfit limitations. Further, the Backfit Rule protects licensees from Commission actions that arbitrarily change license terms and PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Federal Register Notification Paperwork Reduction Act Statement This RIS revision does not contain information collections and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid Office of Management and Budget control number. Contact Please direct any questions about this matter to Don A. Johnson at (301) 415– 4040, or by e-mail: don.johnson@nrc.gov. End of Draft Regulatory Issue Summary Documents may be examined, and/or copied for a fee, at the NRC’s Public Document Room at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site, http://www.nrc.gov/NRC/ADAMS/ index.html. If you do not have access to ADAMS or if you have problems in accessing the documents in ADAMS, contact the NRC Public Document Room (PDR) reference staff at 1–800–397–4209 or 301–415–4737 or by e-mail to pdr@nrc.gov. Dated at Rockville, Maryland, this 17th day of August 2009. For the Nuclear Regulatory Commission. Martin C. Murphy, Chief, Generic Communications Branch, Division of Policy and Rulemaking, Office of Nuclear Reactor Regulation. [FR Doc. E9–20334 Filed 8–21–09; 8:45 am] BILLING CODE 7590–01–P E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 74, Number 162 (Monday, August 24, 2009)]
[Notices]
[Pages 42699-42703]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20334]


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NUCLEAR REGULATORY COMMISSION

[NRC-2009-0365]


Proposed Generic Communication; NRC Regulatory Issue Summary 
2005-02, Revision 1, Clarifying the Process for Making Emergency Plan 
Changes

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of opportunity for public comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to 
issue a regulatory issue summary (RIS) to clarify the process for 
making emergency plan changes. This FRN version of the draft Regulatory 
Issue Summary (RIS) does not include the Attachments and Enclosures as 
described in the body of the RIS. To view these attachments and 
enclosures, refer to the NRC's Agencywide Documents Access and 
Management System (ADAMS), document number ML080710029. The NRC's 
internal non-concurrence process ``Draft Management Directive 10.158, 
`NRC Non-Concurrence Process','' has been invoked by a member of the 
NRC staff regarding draft RIS 2005-01, Revision 1. The non-concurrence 
and supporting information is publically available through ADAMS 
Accession No. ML092250622.

DATES: Comment period expires October 8, 2009. Comments submitted after 
this date will be considered if it is practical to do so, but assurance 
of consideration cannot be given except for comments received on or 
before this date.

ADDRESSES: You may submit comments by any one of the following methods. 
Please include Docket ID NRC-2009-0365 in the subject line of your 
comments. Comments submitted in writing or in electronic form will be 
posted on the NRC Web site and on the Federal rulemaking Web site 
Regulations.gov. Because your comments will not be edited to remove any 
identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed.
    The NRC requests that any party soliciting or aggregating comments 
received from other persons for submission to the NRC inform those 
persons that the NRC will not edit their comments to remove any 
identifying or contact information, and therefore, they should not 
include any information in their comments that they do not want 
publicly disclosed.
    Federal Rulemaking Web site: Go to http://www.regulations.gov and 
search for documents filed under Docket ID NRC-2009-0365. Address 
questions about NRC dockets to Carol Gallagher at 301-492-3668; e-mail 
Carol.Gallagher@nrc.gov.
    Mail comments to: Michael T. Lesar, Chief, Rulemaking and 
Directives Branch (RDB), Division of Administrative Services, Office of 
Administration, Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by fax to RDB at (301) 492-
3446.

FOR FURTHER INFORMATION CONTACT: Don A. Johnson at 301-415-4040 or by 
e-mail at don.johnson@nrc.gov.

SUPPLEMENTARY INFORMATION:

NRC Regulatory Issue Summary 2005-02, Revision 1; Clarifying the 
Process for Making Emergency Plan Changes

Addressees

    All holders of licenses for nuclear power reactors under the 
provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part 
50, ``Domestic Licensing of Production and Utilization Facilities,'' 
including those that have permanently ceased operations and have 
certified that fuel has been permanently removed from the reactor 
vessel.
    All holders of licenses for research and test reactors under Part 
50.
    All holders of and applicants for nuclear power plant construction 
permits, early site permits and limited work authorizations under Part 
50.
    All holders of a combined license for a nuclear power plant under 
the provisions of 10 CFR part 52, ``Licenses, Certifications, and 
Approvals for Nuclear Power Plants.''
    All holders of licenses for fuel facilities under the provisions of 
10 CFR part 40 ``Domestic Licensing of Source Material'' required to 
have an emergency plan under Sec.  40.31(j)(1)(ii).
    All holders of licenses for fuel facilities under the provisions of 
10 CFR part 70 ``Domestic Licensing of Special Nuclear Material'' 
required to have an emergency plan under Sec.  70.22(i)(1)(ii).
    All holders of certifications for gaseous diffusion plants under 
the provisions of 10 CFR part 76 ``Certification of Gaseous Diffusion 
Plants'' required to have an emergency plan under Sec.  76.35(f).
    All holders of site-specific licenses for Independent Spent Fuel 
Storage Installations under 10 CFR part 72 ``Licensing Requirements for 
the Independent Storage of Spent Nuclear Fuel and High-Level 
Radioactive Waste, and Reactor-Related Greater Than Class C Waste.''

Intent

    The U.S. Nuclear Regulatory Commission (NRC) is issuing this 
regulatory issue summary (RIS) revision to inform stakeholders that 
reactor emergency plan changes that require prior NRC approval, in 
accordance with 10 CFR 50.54(q), will need to be submitted as license 
amendment requests in accordance with 10 CFR 50.90, ``Application for 
Amendment of License, Construction permit, or Early Site Permit.'' In 
addition, this revision will (1) clarify the meaning of ``decrease in 
effectiveness'', as stated in 10 CFR 50.54(q); (2) clarify the process 
for evaluating proposed changes to emergency plans; (3) provide a 
method for evaluating proposed changes to emergency plans; (4) provide 
clarifying guidance on the appropriate content and format of 
applications submitted to the NRC for approval prior to implementation; 
and (5) clarify what constitutes a report of emergency plan changes to 
be submitted to the NRC in accordance with 10 CFR 50.54(q). This 
revision supersedes RIS 2005-02, dated February 14, 2005, in its 
entirety due to the extent of changes.
    (1) For non-reactor facilities, the regulations in 10 CFR 40.35(f), 
70.32(i), and 76.91(o) provide direction to licensees seeking to revise 
their emergency plan. An emergency plan includes the plan as originally 
approved by the NRC and all subsequent changes made by the licensee 
with, and without, prior NRC review and approval under these 
regulations. The current practice for non-reactor facilities concerning 
emergency plan changes that require

[[Page 42700]]

prior NRC approval is to submit the changes as a license amendment 
request. Current regulatory guidance for non-reactor emergency plans is 
contained within Regulatory Guide 3.67, ``Standard Format and Content 
for Emergency Plans for Fuel Cycle and Materials Facilities.'' The NRC 
staff is working on updating Regulatory Guide 3.67 to include 
applicable elements of this RIS for fuel cycle facilities. The NRC will 
publish a Federal Register Notice of the issuance for public comment 
and availability of the draft updated Regulatory Guide.
    (2) For Independent Spent Fuel Storage Installations (ISFSI), the 
emergency plan change process should be followed in accordance with 10 
CFR 72.44(f). The information in this RIS provides useful examples of 
the type of evaluations NRC expects ISFSI licensees to conduct in 
reviewing changes to their Part 72 approved emergency plans (refer to 
Sec.  72.24(k) and Sec.  72.32) and determining if the changes may be 
made without prior NRC approval as required by Sec.  72.44(f). The 
current practice for non-reactor facilities concerning emergency plan 
changes that require prior NRC approval is to submit the changes as a 
license amendment request. Additional guidance on emergency planning 
for ISFSI licensees is provided in Spent Fuel Storage and 
Transportation Interim Staff Guidance--16, ``Emergency Planning.''
    This RIS revision requires no action or written response on the 
part of addressees.

Background Information

    The regulation in 10 CFR 50.54(q) provides direction to licensees 
seeking to revise their emergency plan. The requirements related to 
nuclear power plant emergency plans are given in the standards in 10 
CFR 50.47, ``Emergency Plans,'' and the requirements of Appendix E, 
``Emergency Planning and Preparedness for Production and Utilization 
Facilities'' to 10 CFR Part 50. The standards in Sec.  50.54(q) and 
Appendix E to Part 50 also establish the requirements related to 
emergency plans for research and test reactors. Based upon feedback 
from the nuclear power industry, the research and test reactor 
community, and experience gained by the NRC staff after reviewing 
emergency plan changes, the NRC staff has identified a need to clarify 
the process for making changes to an emergency plan and to provide 
licensees with a consistent method for evaluating proposed emergency 
plan changes.
    In addition, the NRC staff clarifies herein that the license 
amendment process is the correct process to use when reviewing decrease 
(reduction) in effectiveness submittals. Courts have found that 
Commission actions that expand licensees' authority under their 
licenses without formally amending the licenses constitute license 
amendments and should be processed through the Commission's license 
amendment procedures. See Citizens Awareness Network, Inc. v. NRC, 59 
F.3d 284 (1st Cir. 1995); Sholly v. NRC, 651 F.2d 780 (D.C. Cir. 1980) 
(per curiam), vacated on other grounds, 459 U.S. 1194 (1983); and In re 
Three Mile Island Alert, 771 F.2d 720, 729 (3rd Cir. 1985), cert. 
denied, 475 U.S. 1082 (1986). See also Cleveland Electric Illuminating 
Co. (Perry Nuclear Power Plant, Unit 1), CLI-96-13, 44 NRC 315 (1996). 
A proposed emergency plan change that would reduce the effectiveness of 
the plan would give the licensee a capability to operate at a level of 
effectiveness that was not previously authorized by the NRC. In this 
situation, the licensee's operating authority would be expanded beyond 
the authority granted by the NRC as reflected in the emergency plan 
without the proposed change. Thus, an emergency plan change that would 
reduce the effectiveness of the plan would expand the licensee's 
operating authority under its license. A change expanding the 
licensee's operating authority is, according to the courts, a license 
amendment and must be accomplished through a license amendment process.
    The staff also stated in SECY-08-0024, ``Delegation of Commission 
Authority to Staff to Approve or Deny Emergency Plan Changes that 
Represent a Decrease in Effectiveness,'' dated February 25, 2008, ``To 
make the process by which the NRC will address proposed 10 CFR 50.54(q) 
changes that represent a decrease in effectiveness clearer, the staff 
intends to incorporate language similar to that which currently exists 
in 10 CFR 50.54(p)(1), as part of the planned rulemaking.'' The current 
schedule for the staff's emergency preparedness (EP) rulemaking calls 
for the final rule to be issued no earlier than the summer of 2010. 
Because of the timeframe associated with the rulemaking, the staff has 
determined that the prudent action is to issue a RIS to clarify that 
licensees must submit proposed emergency plan changes which represent a 
decrease in effectiveness for NRC approval as specified in Sec.  
50.54(q), and the license amendment process is the correct process for 
the staff to use in reviewing the proposed change. For purposes of 
discussion and to incorporate the possibility of future regulatory 
changes, the term ``decrease in effectiveness'' is considered 
synonymous with ``reduction in effectiveness (RIE).''

Summary of Issue

    Licensees routinely evaluate proposed revisions to their emergency 
plan, to determine if these changes reduce the effectiveness of their 
current approved emergency plan or adversely affect their ability to 
implement the emergency plan. Clarification is needed of an acceptable 
method for licensees to use in consistently evaluating proposed changes 
to the emergency plan to ensure the licensee's ability to maintain and 
implement the approved emergency plan. Additionally, licensees should 
understand the process for submitting proposed emergency plan changes 
to the NRC for approval prior to implementation when there is a 
determination of a decrease (reduction) in effectiveness.
    The change process is described below and clarified by providing a 
screening criterion that would ensure consistency of emergency plan 
change determinations of a decrease (reduction) in effectiveness. 
Enclosure 1, ``10 CFR 50.54(q) Evaluation Procedure,'' presents a 
suggested outline for applying the screening criteria for the 
evaluation of a proposed emergency plan change, which is graphically 
depicted in Attachment 1 to Enclosure 1, ``10 CFR 50.54(q) Flowchart.'' 
In addition, Enclosure 2, ``Guidance for Content of Emergency Plan 
Submittals to NRC Requiring Prior NRC Approval,'' provides guidance to 
licensees in the development of their application for NRC prior 
approval of proposed emergency plan changes. The information in this 
RIS revision clarifies the process for changing emergency plans to 
ensure that licensees maintain effective emergency plans thereby 
maintaining reasonable assurance that adequate protective measures can 
and will be taken in the event of a radiological emergency. This RIS 
revision also provides a consistent methodology for licensees to 
evaluate changes to their emergency plans and provides clarifying 
guidance for the development of applications for NRC prior approval. 
This will help ensure that NRC review activities and decisions are 
effective, efficient, predictable, and consistent.
    The regulations require licensees to submit a report of each change 
within a specified period of time after the change is made. The NRC 
Inspectors use this report to evaluate the effectiveness of a 
licensee's emergency plan change management program in accordance with 
NRC Inspection Procedures, and

[[Page 42701]]

although not required, the inclusion of the applicable licensee 
evaluation and justification for the change as part of this report 
would be beneficial to the staff.
Regulation
    In part, 10 CFR 50.54(q) states the following:

    The nuclear power reactor licensee may make changes to these 
plans without Commission approval only if the changes do not 
decrease the effectiveness of the plans and the plans, as changed, 
continue to meet the standards of Sec.  50.47(b) and the 
requirements of appendix E to this part. The research reactor and/or 
the fuel facility licensee may make changes to these plans without 
Commission approval only if these changes do not decrease the 
effectiveness of the plans and the plans, as changed, continue to 
meet the requirements of appendix E to this part* * *. Proposed 
changes that decrease the effectiveness of the approved emergency 
plans may not be implemented without application to and approval by 
the Commission.
Definitions
    (1) Decrease (Reduction) in Effectiveness (RIE)
    (a) A change in an emergency plan that results in reducing the 
licensee's capability to perform an emergency planning function in the 
event of a radiological emergency.
    (i) Note that other licensee activities could affect the ability to 
implement the emergency plan effectively. Licensees must maintain the 
effectiveness of their NRC approved emergency plans, up to and 
including ensuring that changes made to other programs, structures, 
systems or components do not adversely impact the licensee's ability to 
effectively implement its emergency plan. See Information Notice 2005-
19, ``Effect of Plant Configuration Changes on the Emergency Plan,'' 
dated July 18, 2005, for additional information.
    (1) An RIE will occur if there is a change or reduction in an 
emergency planning function without a commensurate reduction or change 
in the bases for that emergency planning function or without measures 
put in place to reduce the impact of the proposed change to the 
emergency plan. The overall impact of proposed changes on the 
effectiveness of the emergency plan or its implementation is to be 
determined, not just the effect that individual changes have on a 
specific part of the emergency plan.
    (2) The following provides some examples of RIEs that would require 
prior NRC approval without a commensurate reduction or change in the 
bases for that emergency planning function or without measures put in 
place to reduce the impact of the proposed change to the emergency 
plan. These examples should not be viewed as being all-inclusive or 
exclusive; rather, licensees should use them to inform decisions 
involving various changes being considered. It is also possible that 
site-specific situations may make a particular example inapplicable to 
a site. Even if a particular example completely encompasses the change 
being considered, the licensee's emergency plan change evaluation 
should explain why the site-specific implementation of the change would 
not be an RIE for that particular site. It is not sufficient for such 
an analysis to simply cross-reference an example in this RIS revision.
    (a) A change that would cause any of the major functional areas or 
major tasks identified in the emergency plans to be unassigned. An 
example of this would be a technical specification change eliminating 
on-shift radiation technician coverage without making an alternative 
arrangement for providing the requisite technical expertise in a timely 
manner.
    (b) A change that would impede site access for offsite assistance 
relied on in the plan without viable alternate arrangements being made. 
An example would be the closure or planned closure of a major river 
bridge in a case where the route via the nearest available crossing 
would incur a substantial increase in response time.
    (c) A change to the emergency response organization (ERO) callout 
procedures or hardware that would delay ERO notification such that the 
augmentation times in the emergency plans can no longer be achieved. A 
change to communications hardware that would reduce the capability to 
initiate and complete required emergency notifications within 15 
minutes of the emergency declaration.
    (d) A change to the onsite meteorological measurements program such 
that meteorological data currently readily available in emergency 
response facilities in accordance with the emergency plan would no 
longer be readily available.
    (e) A change to hazard assessment and radiation protection 
assignments in re-entry and recovery procedures that would not provide 
an adequate level of personal protection in uncertain reentry 
conditions.
    (f) A change that reduces the availability of site familiarization 
training currently presented to offsite assistance groups (e.g., 
firefighters, local law enforcement, and medical services, including 
mutual aid companies that would support these groups).
    (g) A change that delegates the responsibility for performance of 
various aspects of emergency plan maintenance to contractors or other 
external groups without adequate supervisory oversight to ensure that 
program elements continue to be met (e.g., a change delegating testing 
and maintenance of the Alert and Notification System to an external 
group not subject to typical nuclear facility work process and 
configuration controls).
    (3) For proposed changes to individual emergency action levels 
(EALs) (i.e., not an entire EAL scheme change), an RIE will occur in 
the following cases:
    (a) The proposed change to the EAL would potentially cause an 
underclassification (e.g., what was considered an Alert in the approved 
emergency plan would now be considered an Unusual Event or not 
classified at all).
    (b) The proposed change to the EAL would potentially cause an 
overclassification (e.g., what was considered a Site Area Emergency in 
the approved emergency plan would now be considered a General Emergency 
with potential consequences for public health and safety).
    (c) If the proposed change to the EAL is to change an Initiating 
Condition setpoint (or threshold) without a commensurate change in the 
regulatory basis for the EAL Initiating Condition setpoint (or 
threshold).
    (d) The actual numerical setpoint of a given EAL may be revised 
without prior NRC approval under the following conditions via the 10 
CFR 50.54(q) emergency plan change process:
    (i) The regulatory basis for the EAL setpoint has been revised and 
is approved via a letter to the licensee or a Safety Evaluation (SE). 
For example, a site receives NRC approval (via a SE) for power up-rate. 
Power up-rate implementation causes the ``normal'' radiation levels to 
increase, thus necessitating an increase in EAL setpoints based on 
``normal'' radiation levels. The regulatory basis for the setpoint has 
been changed, thus this change can be processed via the emergency plan 
change process because the effectiveness of the emergency plan has not 
been reduced.
    (ii) The regulatory basis for the EAL setpoint has not been changed 
but the method for detection of the setpoint has been changed. For 
example, a given EAL setpoint is based upon exceeding 1 Rem total 
effective dose equivalent (TEDE). The radiation monitor reading 
setpoint is based upon a reading that would give the equivalent of 
exceeding 1 Rem

[[Page 42702]]

TEDE. The radiation monitor is replaced and operates differently. The 
actual numerical value of the EAL needs to be revised to that which is 
equivalent to 1 Rem TEDE. The regulatory basis for the setpoint has not 
been changed, thus this change can be processed via the emergency plan 
change process as the effectiveness of the emergency plan has not been 
reduced.
    (2) Emergency plan
    (a) The document(s) prepared and maintained by the licensee that 
identify and describe the licensee's methods for maintaining and 
performing emergency planning functions. An emergency plan includes the 
plans as originally approved by the NRC and all subsequent changes made 
by the licensee with, and without, prior NRC review and approval under 
10 CFR 50.54(q).
    (i) The licensee's emergency plan consists of:
    (1) The emergency plan as approved by the NRC via a Safety 
Evaluation Report, SE, or license amendment (LA) from the Office of 
Nuclear Reactor Regulation (NRR) or the Office of Federal and State 
Materials and Environmental Management Programs (FSME).
    (2) Changes to the emergency plan explicitly reviewed by the NRC 
through an SE, or LA from NRR or FSME, and found to meet the applicable 
regulations.
    (3) Changes to the emergency plan explicitly reviewed by the NRC 
through an SE, or LA, and found to be an approved amendment to the 
licensee's emergency plan.
    (4) Changes made by the licensee without NRC review and approval 
after the licensee concluded that the change(s) do not constitute a 
RIE.
Emergency Plan Change Process
1. Process Overview
    Reasonable assurance that adequate protective measures can and will 
be taken in the event of a radiological emergency is based on the 
licensee's emergency plan, and the successful implementation of that 
emergency plan. The body of an emergency plan contains statements that 
describe how a licensee will meet regulatory requirements. The 
standards of 10 CFR 50.47(b) and the requirements of Appendix E to 10 
CFR part 50 establish the contents of the nuclear power reactor 
emergency plan. The standards in Sec.  50.54(q) and Appendix E to Part 
50 establish the requirements related to emergency plans for research 
and test reactors. Subsequent changes to the emergency plan must comply 
with Sec.  50.54(q). Enclosure 1 outlines the emergency plan change 
process, and Attachment 1 to Enclosure 1 graphically depicts the 
process in a flowchart.
2. Emergency Plan Review
    Changes to an emergency plan may result from advances in 
technology, new or revised rules, site-specific needs, processes, 
guidance (such as Nuclear Energy Institute guidance endorsed by the 
NRC), technical specification changes, or modifications to 
instrumentation. Changes that the licensee has identified as RIEs must 
be submitted to the NRC for review and prior approval. The NRC staff 
will review the emergency plan change against the standards, 
regulations, guidance documents and the approved emergency plan. The 
NRC will review and approve submittals on a case-by-case basis. An 
emergency plan change approved for one licensee does not mean that the 
same or similar change would be approved for another licensee.
    For the purposes of determining whether a change to a licensee's 
emergency plan constitutes an RIE, the licensee should use the last 
emergency plan reviewed and approved by the NRC. If the emergency plan 
change process has been properly implemented over the years, comparing 
a proposed emergency plan change to either the latest emergency plan 
reviewed and approved by the NRC or the emergency plan as changed by 
the licensee should result in the same RIE determination. For example, 
if a licensee made a series of changes over time to the same specific 
provision of the emergency plan, where each change was separately 
determined not to constitute an RIE, then there should be no RIE. 
Therefore, there should be no RIE when comparing the latest emergency 
plan to the emergency plan reviewed and approved by the NRC. If a 
licensee or the NRC concludes that there is a RIE due to a series of 
changes over time, then the provisions of the emergency plan change 
process have not been correctly followed.
    The EP requirements are a framework for how the licensee will meet 
the applicable standards and requirements of the regulations. If a 
licensee has determined that an EP requirement should be increased in 
order to meet the planning standards or Appendix E to Part 50 
requirements, these changes must follow the emergency plan change 
process and revise the emergency plan to reflect this increase to the 
EP requirement. Nevertheless, whether or not an emergency plan change 
results in a RIE is not determined by assessing whether NRC regulatory 
requirements continue to be met after the EP requirement has been 
changed. The licensee's emergency plan may include EP requirements that 
exceed the baseline standards and requirements as set forth in Sec.  
50.47(b) and Appendix E to Part 50. For the RIE determination, the 
change or changes should be evaluated against the capability to perform 
the functions and the associated time requirement of performing the 
function, if applicable. The evaluation should document whether the 
capability or timeliness to perform a function is lost and/or degraded. 
In addition to the RIE determination, the change or changes should also 
be evaluated to verify that they continue to meet the standards and 
requirements as set forth in Sec.  50.47(b) and Appendix E to Part 50.
    The current Commission requirements for document retention in Sec.  
50.54(q), specify that changes that do not warrant NRC approval must be 
retained for 3 years. The licensee must retain changes that reduce the 
effectiveness of the emergency plan until the Commission terminates the 
license. It may be prudent to save emergency plan change documentation 
to show the historical progression of changes, since the Commission, 
through its staff, may review at any time, the emergency plan changes 
that have been made.
Related Topics Regarding Emergency Plan Changes
1. Regulatory Process for Evaluating Licensee Requests for NRC Prior 
Approval of Emergency Plan Changes Determined To Be a RIE in Accordance 
With 10 CFR 50.54(q)
    Similar to security plan changes submitted via 10 CFR 50.54(p)(1), 
emergency plan changes that result in the reduction in the 
effectiveness of the approved emergency plan require prior NRC 
approval, under Sec.  50.54(q), and should to be submitted as license 
amendment requests under Sec.  50.90.
2. Emergency Action Level Changes
    A revision to an entire EAL scheme, from NUREG-0654, ``Criteria for 
Preparation and Evaluation of Radiological Emergency Response Plans and 
Preparedness in Support of Nuclear Power Plants,'' to another NRC-
endorsed EAL scheme, must be submitted for prior NRC approval as 
specified in Section IV.B. of Appendix E to 10 CFR Part 50. The 
Statement of Considerations for the final rule amending the NRC's 
regulations relating to NRC approval of EAL changes, dated January 26, 
2005, stated in part, ``The

[[Page 42703]]

Commission believes a licensee's proposal to convert from one EAL 
scheme (e.g., NUREG-0654-based) to another EAL Scheme (NUMARC/NESP-007 
or NEI 99-01 based) * * * is of sufficient significance to require 
prior NRC review and approval. NRC review and approval for such major 
changes in EAL methodology is necessary to ensure that there is 
reasonable assurance that the final EAL change will provide an 
acceptable level of safety.'' Regulatory Guide 1.101, Revisions 3 and 
4, ``Emergency Planning and Preparedness for Nuclear Power Reactor,'' 
endorsed NUMARC/NESP-007 and NEI 99-01 EAL guidance, respectively, as 
acceptable alternatives to the guidance provided in NUREG-0654 for 
development of EALs to comply with Sec.  50.47 and Appendix E to Part 
50. A change in an EAL scheme to incorporate the improvements provided 
in NUMARC/NESP-007 or NEI 99-01 would not decrease the overall 
effectiveness of the emergency plan and would not expand a licensee's 
operating authority beyond that previously authorized by NRC, but due 
to the potential safety significance of the change, the change needs 
prior NRC review and approval. This approval is given via SE and 
letter.
    Revisions of an individual EAL that results in a decrease in 
effectiveness must be submitted for NRC approval as specified in Sec.  
50.54(q), and the license amendment process is the correct process for 
the staff to use in reviewing the proposed change. As discussed 
previously, an emergency plan change that would reduce the 
effectiveness of the plan would expand the licensee's operating 
authority under its license. A change expanding the licensee's 
authority is, according to the courts, a license amendment and must be 
accomplished through a license amendment process. For research and test 
reactors, NUREG-0849, ``Standard Review Plan for the Review and 
Evaluation of Emergency Plans for Research and Test Reactors,'' issued 
October 1983, provides guidance on EALs and how changes should be made 
on a case-by-case basis with consideration of the provisions of Sec.  
50.54(q).
3. Inspection Activities
    For power reactors, the NRC inspectors use Inspection Procedure 
(IP) 71114.04 to conduct a review of the effectiveness of the 
licensee's implementation of the 10 CFR 50.54(q) change process. For 
research and test reactors, the NRC inspectors use IP 69011, ``Class I 
Research and Test Reactor Emergency Preparedness,'' and IP 69001, 
``Class II Research and Test Reactors.'' The inspector will perform a 
screening review of the change relative to the emergency plan; however, 
this will not constitute NRC approval of the plan as changed.
    The documentation of the change reviewed by the inspectors will be 
the report provided by the licensee as stated in Sec.  50.54(q). 
Although not required, the inclusion of the applicable licensee 
evaluation and justification for the change as part of this report 
would assist the staff in the review.
4. Lower Tier Documents
    If a licensee has incorporated a lower tier document into the 
emergency plan or the emergency plan explicitly references a lower tier 
document as a method to implement a specific requirement in the 
emergency plan, then, it is considered part of the plan and subject to 
Sec.  50.54(q) review. Historically, some licensees have developed 
emergency plan implementing procedures that included the necessary 
information needed for activities that are required to meet the 
regulations, for example, procedures for notifications, dose 
assessment, protective action recommendations, emergency 
classifications and emergency action levels. The staff is not making 
the use of Sec.  50.54(q) to review all changes to lower tier documents 
a requirement, but acknowledges that using Sec.  50.54(q) as the 
regulation to provide revision control of these lower tier documents 
has been in place and supported by the NRC through the inspection and 
licensing process.

Backfit Discussion

    This RIS revision does not require any action or written response. 
This RIS revision provides non-regulatory review guidance for licensees 
and clarifies existing regulatory requirements licensees must follow 
when proposing changes to their emergency plans. The NRC's Backfit 
Rule, 10 CFR 50.109, applies to, among other things, the procedures 
necessary to operate a nuclear power plant. To the extent that using a 
license amendment process for making modifications to emergency plans 
that reduce the effectiveness of the plans is considered a change, it 
would be a change to the NRC's regulatory process for addressing 
modifications to the emergency plan. The NRC's regulatory review 
process is not a licensee procedure required for operating a plant that 
would be subject to backfit limitations.
    Further, the Backfit Rule protects licensees from Commission 
actions that arbitrarily change license terms and conditions. In 10 CFR 
50.54(q), a licensee requests Commission authority to do what is not 
currently permitted under its license. The licensee has no valid 
expectations protected by the Backfit Rule regarding the means for 
obtaining the new authority that is not permitted under the current 
license. For these reasons, this RIS revision does not constitute a 
backfit under 10 CFR 50.109, and the staff did not perform a backfit 
analysis.

Federal Register Notification

    To be done after the public comments periods.

Paperwork Reduction Act Statement

    This RIS revision does not contain information collections and, 
therefore, is not subject to the requirements of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
Office of Management and Budget control number.

Contact

    Please direct any questions about this matter to Don A. Johnson at 
(301) 415-4040, or by e-mail: don.johnson@nrc.gov.

End of Draft Regulatory Issue Summary

    Documents may be examined, and/or copied for a fee, at the NRC's 
Public Document Room at One White Flint North, 11555 Rockville Pike 
(first floor), Rockville, Maryland. Publicly available records will be 
accessible electronically from the Agencywide Documents Access and 
Management System (ADAMS) Public Electronic Reading Room on the 
Internet at the NRC Web site, http://www.nrc.gov/NRC/ADAMS/index.html. 
If you do not have access to ADAMS or if you have problems in accessing 
the documents in ADAMS, contact the NRC Public Document Room (PDR) 
reference staff at 1-800-397-4209 or 301-415-4737 or by e-mail to 
pdr@nrc.gov.

    Dated at Rockville, Maryland, this 17th day of August 2009.

    For the Nuclear Regulatory Commission.
Martin C. Murphy,
Chief, Generic Communications Branch, Division of Policy and 
Rulemaking, Office of Nuclear Reactor Regulation.
[FR Doc. E9-20334 Filed 8-21-09; 8:45 am]
BILLING CODE 7590-01-P