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{{#Wiki_filter:FINAL SUPPORTING STATEMENT FOR 10 CFR PART 50 APPLICATIONS SECTION 2 50.30, 55(b) & (d) - Filing Application; Decommissioned Plants 50.54(bb); License Amend. 50.59(c), 50.90, 50.91(a), (b); License Transfers 50.80(b); NRC Notification, 50.74; 50.33 Contents of applications; general information (Early Site Permits; Standard Design Certifications, Combined Licenses, Standard Design Approvals, Manufacturing Licenses, Construction Permits, Operating Licenses); 50.33(f) Financial Qualifications, 50.36,50.36A, 50.36B & Appendix I, Technical Specifications; 50.34(c) & (d) &
50.54(p), Security; 50.35(b), Periodic Reports; 50.34(w)(3) & (4), Property Insurance Damage Insurance 3150-0011 ABSTRACT The U.S. Nuclear Regulatory Commission (NRC) is authorized by Congress to have responsibility and authority for the licensing and regulation of nuclear power plants, research reactors and testing facilities (also known collectively as research and test reactors), fuel reprocessing plants and other utilization and production facilities licensed pursuant to the Act. To meet its responsibilities, the NRC conducts a detailed review of all applications for licenses to construct and operate such facilities. The purpose of the detailed review is to ensure that the proposed facilities can be built and operated safely at the proposed locations, and that all structures, systems and components important to safety will be designed to withstand the effects of postulated accident conditions, without undue risk to the health and safety of the public.
Under 10 CFR Part 50, before a company or other entity can build a production or utilization facility at a particular site, it must obtain a construction permit from the NRC. Subsequently, an operating license must be obtained from the NRC before an applicant can operate the facility. The decision by the NRC as to whether to approve an application for a construction permit or an operating license is based largely on the NRC staff's detailed review of the information provided as part of an application. Information provided by the applicant as part of the application is crucial to the licensing process as it provides the NRC with the information it needs to make a decision with regard to the proposed facility's impact on the public's health and safety and the environment.
The Commission issues an operating license or construction permit, with appropriate conditions and limitations (including technical specifications), after determining that an application for a license meets certain standards and requirements. Licensees must maintain records and prepare reports to demonstrate their fulfillment of regulatory requirements. The information collection requirements in this section include:
* filing application for a license or combined license which includes both general (applicant name; type of business; radiological emergency response plans) and technical information (preliminary or final safety analysis report; descriptions of the equipment and systems);
* submitting technical specifications with administrative controls. Administrative controls are
 
the provisions relating to organization and management, procedures, recordkeeping, review and audit, and reporting necessary to ensure operation of the facility in a safe manner;
* physical security and safeguards contingency plans;
* periodic reports of the progress and results of research and development programs designed to resolve safety questions and reports on the amount and sources of property damage/accident recovery insurance; and
* report describing the implementation of a newly developed probabilistic risk assessment (PRA) method.
These regulations affect 89 licensees for operating nuclear power plants, 31 non-power production and utilization facilities, 15 combined operating license holders/applicants and 29 power plants that are currently being decommissioned. Licensees may voluntarily submit a request for an exemption to the Commission and maintain a record of that request.
Licensees may voluntarily submit a request for an exemption (See Section 6) to the Commission and maintain a record of that request.
A. JUSTIFICATION
: 1. Need for Collection of Information The information is needed in order to determine licensee compliance with the regulations set forth in 50.30, 55(b) & (d); 50.33a & Appendix L; 50.54(bb); 50.59(c),
50.90, 50.91(a), (b); 50.80(b); 50.74; 50.33; 50.36,50.36A, 50.36B & Appendix I,;
50.34(c) & (d) & 50.54(p); 50.35(b), 50.34(w)(3) & (4). Details of these regulations can be found at the end of this supporting statement in Description of Requirements.
: 2. Agency Use and Practical Utility of Information Applicants or licensees requesting approval to construct or operate utilization or production facilities are required by the Atomic Energy Act of 1954, as amended (the Act), to provide information and data that the NRC may determine necessary to ensure the health and safety of the public.
The NRC uses the records and reports required in this part to ascertain that licensees licensing the design, construction, operation, and decommissioning of commercial nuclear power plants and other nuclear facilities programs are adequate to protect public health and minimize danger to life and property and that licensees personnel are aware of and follow up on the information and steps needed to perform licensed activities in a safe manner. The reports and recordkeeping requirements allow NRC to determine whether to take actions, such as to conduct inspections or to alert other licensees to prevent similar events that may have generic implications.
: 3. Reduction of Burden Through Information Technology There are no legal obstacles to reducing the burden associated with this information collection. The NRC encourages respondents to use information technology when it would be beneficial to them. The NRC has issued Guidance for Electronic
 
Submissions to the NRC which provides direction for the electronic transmission and submittal of documents to the NRC. Electronic transmission and submittal of documents can be accomplished via the following avenues: the Electronic Information Exchange (EIE) process, which is available from the NRC's Electronic Submittals Web page, by Optical Storage Media (OSM) (e.g. CD-ROM, DVD), by facsimile or by e-mail. It is estimated that approximately 45% of the responses are filed electronically.
: 4. Effort to Identify Duplication and Use Similar Information No sources of similar information are available. There is no duplication of requirements.
: 5. Effort to Reduce Small Business Burden Not applicable.
: 6. Consequences to Federal Program or Policy Activities if the Collection is Not Conducted or is Conducted Less Frequently If the information is not collected, NRC will not be able to assess whether licensees are operating within the specific safety requirements applicable to the licensing, constructing, and operating activities for nuclear power reactors; research and test reactors; and other production and utilization facilities.
The information and required frequency from licensees that seek to construct and operate nuclear power reactors, research and test reactors; and other production and utilization facilities is essential to NRCs determination of whether the applicant has adequate equipment, training, funds and experience throughout the life of the licensee to protect the public health and safety.
: 7. Circumstances which Justify Variation from OMB Guidelines 10 CFR 50.74 requires that licensees notify the NRC within 30 days of any change in the status of licensed reactor operators or senior operators. The variation is necessary to be sure that temporarily or permanently replaced licensed or senior reactor operators are immediately staffed by qualified personnel.
A few special reports, such as the Licensee Event Reports, required by 10 CFR 50.36(c), 10 CFR 50.72, and 10 CFR 50.73, the Post Accident Monitoring Report (when required), and the Steam Generator Tube Inspection Report, are required in fewer than 30 days to ensure that the NRC promptly responds to situations with the potential to seriously impact public health and safety (also see the Section 4 Supporting Statement). Many of the records involved with this information collection are retained longer than 3 years, some for the life of the plant, to establish patterns or base-line performance to anticipate and assess future trends. These variations are deemed necessary to ensure that the health and safety of the public will not be adversely affected by the operation of the plant.
10 CFR 50.54(w)(4)(ii) requires licensees to provide written notification when the reactor is and can be maintained in a safe and stable condition. This notification could
 
occur in less than 30 days of the event, at which time licensees are expected to provide the required notification.
This notification is necessary to provide the NRC with information to monitor cleanup and to begin allowing the release of insurance proceeds from the decontamination priority and also used for non-cleanup purposes.
: 8. Consultations Outside the NRC Opportunity for public comment on the information collection requirements for this clearance package was published in the Federal Register on February 19, 2021, (86 FR 10360). Additionally, NRC staff contacted five stakeholders via email. The stakeholders were new, operating and research and test reactor owner licensee representatives and interested stakeholders from Duke Energy Progress, LLC, Kairos Power, Southern Nuclear Operating Co., Washington State University and X-Energy.
The NRC received one out-of-scope comment as a result of the FRN. No additional responses or comments were received as a result of the FRN or the staffs direct solicitation of comment.
: 9. Payment or Gift to Respondents Not applicable.
: 10. Confidentiality of Information Confidential and proprietary information is protected in accordance with NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).
: 11. Justification for Sensitive Questions This regulation does not request sensitive information.
: 12. Estimated Industry Burden and Burden Hour Cost The total estimated cost for information collection requirements in this section is estimated to be 682,975 hours at a cost of $ 190,550,025 (682,975 hours x $279/hr).
Total Burden and Responses Section 2 Hours            Responses Reporting          457,342                  2,152 Recordkeeping      225,633                    164 TOTAL              682,975                  2,316 Detailed burden estimates are included in the supplemental burden spreadsheet titled, Table 1 - Summary of Supporting Statements. The $279 hourly rate used in the burden estimates is based on the Nuclear Regulatory Commissions fee for hourly rates as noted in 10 CFR 170.20 Average cost per professional staff-hour. For more
 
information on the basis of this rate, see the Revision of Fee Schedules; Fee Recovery for Fiscal Year 2020 (85 FR 37250, June 19, 2020).
: 13. Estimate of Other Additional Costs The quantity of records to be maintained is roughly proportional to the recordkeeping burden and therefore can be used to calculate approximate records storage costs.
Based on the number of pages maintained for a typical clearance, the records storage cost has been determined to be equal to .0004 times the recordkeeping burden cost.
Therefore, the storage cost for this clearance is estimated to be $25,180 (225,633 recordkeeping hours x $279 x .0004).
: 14. Estimated Annualized Cost to the Federal Government The staff has developed estimates of annualized costs to the Federal Government related to the conduct of this collection of information. These estimates are based on staff experience and subject matter expertise and include the burden needed to review, analyze, and process the collected information and any relevant operational expenses.
The annualized estimated cost to the government is $28,444,887 (101,953 hours x
    $279) as shown on the attached Summary Table.
: 15. Reasons for Changes in Burden or Cost The burden and number of responses have changed as described in the tables below:
Burden change 2018                  Current Change estimates          submission Reporting                    440,901.7          457,342            16,440.3 Recordkeeping                230,820.5          225,633              -5,187.5 Third Party 0.0                                      0 Disclosure                                              0 Total                        671,722.2          682,975            11,252.8 Change in Responses 2018            Current Change estimates      submission Reporting                        2,152            2,152                      0 Recordkeeping                      153              164                11.00 Third Party 0                0                      0 Disclosure Total                          2,305.3            2,316                11.00 Overall, for this section, the changes are attributed the increase in certificate holders and decommissioning plants, and a decrease in operating reactors and sites.
 
The largest increase in burden is due to an increase in the estimated number of license amendments under 50.59(c), 50.90, 50.91(a), and (b). The number of estimated license amendments increased from 918 to 984. At 313 hours per license amendment, this resulted in an increase of 20,658 hours. In addition, 6,000 hours of burden was added for license amendments related to topical reports.
The largest decrease in burden is associated with technical specifications for operating power reactors. Due to a change in the number of operating reactors from 94 to 89, the estimated burden for this section decreased from 195,520 to 185,120, a decrease of 10,400 hours. The burden for technical specifications for shutdown reactors increased by 3,120 hours. The burden for technical specifications is lower for a shutdown reactor (208 hours rather than 2080 hours); therefore, the overall burden for technical specifications was a net decrease.
In addition, the burden for 50.34(c) & (d) & 50.54(p) that is covered under 10 CFR 73.67 (approved by OMB under Clearance No. 3150-0002) has been removed, which reduced the responses by 76.
: 16. Publication for Statistical Use The information being collected is not expected to be published for statistical use.
: 17. Reason for Not Displaying the Expiration Date The recordkeeping and reporting requirements for this information collection are associated with regulations and are not submitted on instruments such as forms or surveys. For this reason, there are no data instruments on which to display an OMB expiration date. Further, amending the regulatory text of the CFR to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.
: 18. Exceptions to the Certification Statement None.
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable.
 
Appendix A - Description Requirements Applications 10 CFR 50.30 This section provides for the filing of an application for early site permits; standard design certifications, combined licenses, standard design approvals, manufacturing licenses, construction permits, and operating licenses which includes both general and technical information. General information is covered under Section 50.33, and technical information is covered under Section 50.34. Provisions pertaining to technical information submitted in applications currently in Section 50.34 for early site permits, standard design certifications, and combined licenses are being amended to move these requirements to, and cover the burden in, Part 52. The general information required by Section 50.33 will remain in Part 50. Section 50.30(f) also requires that an Environmental Report (ER) be submitted pursuant to Part 51. The information collection burden associated with the ER is covered by a separate OMB clearance for Part 51 (3150-0021) and, therefore, no environmental burden is included for Section 50.30.
10 CFR 50.33. This section requires each application to provide general information such as: applicant name, address, type of business (partnership or corporation),
citizenship, to identify the class of license, how the license will be used, the time period for the license, a list of other related licenses and provide details about the applicant's financial qualifications and emergency response plans.
10 CFR 50.33(f) This subsection requires the applicant to submit information demonstrating the financial qualification of the applicant to carry out, in accordance with regulations in this chapter, the activities for which the permit or license is sought.
Under subsection 50.33(f)(5) the Commission may request an established entity or newly formed entity to submit additional or more detailed information respecting its financial arrangements and status of funds if the Commission considers this information appropriate. This may include information regarding a licensees ability to continue the conduct of the activities authorized by the license and to decommission the facility.
10 CFR 50.33(g). This section of 10 CFR 50 requires that the applicant for an operating license submit state and local government radiological emergency response plans. The plans shall define the Emergency Planning Zone (EPZ) for the plume exposure pathway and the ingestion pathway. Generally, with the nuclear facility located at the center, the plume exposure pathway for the EPZ will cover an area with a radius of approximately 10 miles, and the ingestion pathway will cover an area with a radius of approximately 50 miles. The exact size and configuration of the EPZ will be determined in relation to the local emergency response needs and capabilities as they are affected by such conditions as demography, topography, access routes and jurisdictional boundaries.
10 CFR 50.54(bb). This section requires that for operating nuclear power reactors, the licensee shall, within 2 years following permanent cessation of operation of the reactor or 5 years before expiration of the reactor operating license, whichever occurs first, submit written notification to the Commission for its review and
 
preliminary approval of the program by which the licensee intends to manage and provide funding for the management of all irradiated fuel at the reactor following permanent cessation of operation of the reactor until title to the irradiated fuel and possession of the fuel is transferred to the Secretary of Energy for its ultimate disposal in a repository. Final Commission review will be undertaken as part of any proceeding for continued licensing under 10 CFR 50 or 10 CFR 72. The licensee must demonstrate to the NRC that the elected actions will be consistent with NRC requirements for licensed possession of irradiated nuclear fuel and that the actions will be implemented on a timely basis. Where implementation of such actions requires NRC authorizations, the licensee shall verify in the notification that submittals for such actions have been or will be made to the NRC and shall identify them. A copy of the notification shall be retained by the licensee as a record until expiration of the reactor operating license. The licensee shall notify the NRC of any significant changes in the proposed waste management program as described in the initial notification.
10 CFR 50.55(b). This section specifies that if the proposed construction or modification of a facility is not completed by the latest completion date specified in the construction permit, the permit shall expire and all rights there under shall be forfeited. However, if good cause can be shown by the applicant, the Commission may extend the completion date for a reasonable period of time. The Commission will recognize, among other things, developmental problems attributable to the experimental nature of the facility or fire, flood, explosion, strike, sabotage, domestic violence, enemy action, an act of the elements, and other acts beyond the control of the permit holder, as a basis for extending the completion date. No completion date extensions are expected during this clearance period. Thus, the relevant burden is zero.
Pursuant to 10 CFR 50.55(d), at or about the time of completion of the construction or modification of the facility, the applicant must file any additional information needed to bring the original application for license up to date, and must file an application for an operating license or an amendment to an application for a license to construct and operate the facility for the issuance of an operating license, as appropriate, as specified in 10 CFR 50.30(d).
10 CFR 50.59(c), 50.90, 50.91(a) and (b). These sections are applicable for amendment of licenses to operating nuclear power plants, research and test reactors, and other production and utilization facilities, amendment of licenses to permanently shut down nuclear power and research and test reactors and other production and utilization facilities and amendments to combined licenses, manufacturing licenses, early site permits and construction permits. 10 CFR 50.59(c) requires the holder of a license authorizing operation of a production or utilization facility who desires to make a change to the facility or procedures as described in the FSAR or to conduct tests or experiments not described in the FSAR to submit an application for amendment of the license pursuant to 10 CFR 50.90 if the change, experiment, or test does meet certain criteria or a change to the TS is required. 10 CFR 50.59 (d)(2) requires the licensee to submit a report of these changes and the corresponding evaluations at intervals not to exceed 24 months. Amendments to permits and licenses may also be submitted by holders of
 
construction permits, early permits, manufacturing licenses, and combined licenses (prior to the operation of the nuclear power plant).
10 CFR 50.90 requires the application for amendment of the license or permit to be filed with the Commission, fully describing the changes and following as far as applicable in the form prescribed for original applications.
The application for amendment of the license or permit enables the staff to evaluate any changes made at the facility or any new information concerning the facility that may potentially affect the safety of the facility and consequently the health and safety of the public.
Under 10 CFR 50.91(a)(1) and (b)(1), a licensee requesting an amendment must provide to the NRC and the State in which its facility is located, the amendment application and an analysis concerning the issue of no significant hazards consideration. NRC needs licensees' and permit holders analyses to quickly make and publish for public comment its proposed determination about no significant hazards consideration; the States need licensees' and permit holders analyses in order to quickly consult with the NRC.
On July 19, 1995, the Commission published in the Federal Register (60 FR 36953) its final rule on TS for nuclear power reactors. The rule codified the criteria identified in the final policy statement for determining the content of TS. A major benefit of the rule involves the reduction in the number of safety functions controlled by TS (limiting conditions for operation) by applying the criteria. The rule ensures that any changes to the most safety significant features will require prior review and approval by NRC. The safety functions that do not satisfy the criteria can be relocated to licensee-controlled documents and changed pursuant to 10 CFR 50.59.
The burden on licensees and the NRC can be reduced by relocating such provisions or, for power reactor licensees, completely converting the existing TS to the improved Standard Technical Specifications (STS). Recordkeeping and reporting requirements for revisions that do not require an amendment are covered in Section 5 of this clearance submittal.
10 CFR 50.80(b) This section specifies that an application for a transfer of a license shall include as much of the information described in 10 CFR 50.33 and 50.34 with respect to the identity and technical and financial qualifications of the proposed transferee as would be required by those sections if the application were for an initial license. 10 CFR 50.80(b) also specifies that the Commission may require additional information, such as data with respect to proposed safeguards against hazards from radioactive materials, and the transferee's qualifications to protect against such hazards.
The requirements described above are needed to assure the transferee's financial capability to run the facility safely and to ensure the transferee's technical capability to properly and safely operate the facility in a way that protects the health and safety of the public.
 
Procedures for aircraft impact and beyond-design basis threat The Power Reactor Security Final Rule, approved by OMB in April 2009, established and updated generically applicable security requirements similar to those previously imposed by Commission orders issued after the terrorist attacks of September 11, 2001. This rule added sections 50.54(hh) (1)&(2):
10 CFR 50.74 This section requires licensees of nuclear power facilities to notify the NRC within 30 days of a change in status of a licensed reactor operator or senior operator. The NRC needs to know if operators have been permanently reassigned, terminated, or have undergone permanent disability, or illness as required by 10 CFR 55.25, to ensure that a qualified replacement has been assigned. (Note that notifications involving 10 CFR 55.25 are cleared under OMB Clearance No. 3150-0024.)
10 CFR 50.36 requires licensees to maintain technical specifications with administrative controls. Administrative controls are the provisions relating to organization and management, procedures, recordkeeping, review and audit, and reporting necessary to ensure operation of the facility in a safe manner. These reporting and recordkeeping requirements are set forth in the Technical Specifications (TS), Appendix A to the operating license for each facility license.
Pursuant to 10 CFR 50.36b, environmental reporting and recordkeeping requirements are set forth in Appendix B to the operating license for each facility license or in each licensees environmental protection plans. (A few facilities have a single appendix that contains the combined aspects of both Appendices A and B).
10 CFR 50.36(a) requires each applicant for a license authorizing operation of a production or utilization facility to include in its application proposed TS. A summary statement of the bases or reasons for such specifications, other than those covering administrative controls, shall also be included in the application.
10 CFR 50.36(b) requires each license authorizing operation of a production or utilization facility to include TS. The TS are derived from the analyses and evaluations included in the safety analysis report, and amendments thereto, submitted pursuant to 10 CFR 50.34.
10 CFR 50.36(c) specifies that limiting conditions for operations (LCO) are the lowest functional capability or performance levels of equipment required for safe operation of a facility. When an LCO of a nuclear reactor is not met, the licensee shall shutdown the reactor or follow any remedial action permitted by the technical specifications until the condition can be met. A completion time (CT) is the duration for which a licensee may continue to operate when it does not meet the requirements for lowest functional capability. Licensees can use PRA models acceptable to the NRC to estimate CTs. Those licensees shall submit reports to NRC if their PRA models incorporate newly developed methods.
10 CFR 50 Appendix I consists of numerical guides for design objectives and limiting conditions for plant operation to meet the criterion "as low as is reasonably achievable" for radioactive material in light-water-cooled reactor effluents.
 
Section 50.34(c)(3) requires that each plan must describe how the applicant will meet the requirements of 10 CFR 73 (and 10 CFR 11, if applicable, including the identification and description of jobs as required by 10 CFR 11.11(a), at the proposed facility). The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with the requirements of 10 CFR 11 and 10 CFR 73, if applicable. 10 CFR 73.67 prescribes requirements for the establishment and maintenance of a physical protection system which will have capabilities for the protection of SNM at fixed sites and in transit and for plants in which SNM is used.
10 CFR 11 prescribes criteria and procedures for determining eligibility for access to, or control over, certain quantities of SNM. The burden to provide this information is included in the OMB clearance for 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants (3150-0151).
Section 50.34(d)(1) requires that each application for a license to operate a production or utilization facility that will be subject to 10 CFR 73.50 and 10 CFR 73.60 must include a licensee SCP in accordance with 10 CFR 73 Appendix C. The SCP shall include plans for dealing with threats, thefts, and radiological sabotage as defined in 10 CFR 73. Four categories of information must be included in the applicant's SCP. These categories are specified in 10 CFR 73 Appendix C. First, the "Background" must identify and define the perceived dangers and incidents with which the plan will deal and the general way it will handle them. Second, the "Generic Planning Base" must define the criteria for initiation and termination of responses to safeguards contingencies together with the specific decisions, actions, and supporting information needed to bring about such responses. Third, the "Licensee Planning Base" must include the factors affecting contingency planning that are specific to the facility. The fourth category relates to a "Responsibility Matrix" that must include a detailed identification of the organizational entities responsible for each decision and action associated with specific responses to safeguards contingencies. The burden to provide this information is included in the OMB clearance for 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants (3150-0151).
Section 50.54(p)(1) requires that each licensee prepare and maintain SCP procedures in accordance with 10 CFR 73 Appendix C. Procedures must be established in order to aid execution of the detailed plan as developed in the "Responsibility Matrix" section of the SCP. The procedures must detail the actions to be taken and decisions to be made by each member or unit of the organization as planned in the "Responsibility Matrix." The procedures need not be submitted to the Commission for approval, but are inspected by the NRC staff on a periodic basis.
The burden to provide this information is included in the OMB clearance for 10 CFR Part 73, Physical Protection of Plants and Materials (3150-0002).
Section 50.54(p)(1) specifies that the licensee may make no change which would decrease the effectiveness of a PSP, or T&QP or CSP (required by 10 CFR 73.55 and 10 CFR 73.54) prepared pursuant to 10 CFR 50.34(c) or 10 CFR 73 or to the first four categories of information contained in the SCP prepared pursuant to 10 CFR 50.34(d) or 10 CFR 73, as applicable, without prior approval of the Commission. A licensee desiring to make such a change must submit an application for an amendment to the licensee's license pursuant 10 CFR 50.90.
 
Section 50.54(p)(2) also specifies that a licensee may make changes to the plans referenced in 10 CFR 50.54(p)(1) without prior approval if the changes do not decrease the safeguards effectiveness of the safeguards plan. The licensee, however, must maintain records of changes to the plans for a period of three years from the date of the change and must submit a report containing a description of each change within two months after the change is made.
Section 50.54(p)(3) requires the licensee to provide for the development, revision, implementation, and maintenance of its SCP. To this end, the licensee shall provide for a review at least every 12 months of the SCP by individuals independent of both security program management and personnel who have direct responsibility for implementation of the security program. All elements of the SCP must be reviewed at least once every 24 months.
Section 50.54(p)(4) requires that the review must include a review and audit of safeguards contingency procedures and practices, an audit of the security system testing and maintenance program, and a test of the safeguards systems along with commitments established for response by local law enforcement authorities. The results of the review and audit, along with recommendations for improvements, must be documented, reported to the licensee's corporate and plant management, and kept available at the plant for inspection for a period of three years. The burden to provide this information is included in the OMB clearance for 10 CFR Part 73, Physical Protection of Plants and Materials (3150-0002).
10 CFR 50.35(b) specifies that "The Commission may, in its discretion, incorporate in any construction permit provisions requiring the applicant to furnish periodic reports of the progress and results of research and development programs designed to resolve safety questions.
Under 10 CFR 50.54(w)(3), licensees are required to report annually on the amount and sources of this required insurance.
Under 10 CFR 50.54(w)(4)(i) and 10 CFR 50.54(w)(4)(ii), a licensee suffering an accident is required to submit a cleanup plan outlining the steps and costs needed to complete decontamination and cleanup and to allow release of the remaining insurance proceeds for non-cleanup purposes.
10 CFR 50.54(w)(4)(I) establishes a threshold of $100 million before a cleanup plan would be required.
10 CFR 50.54(w)(4)(ii) requires licensees to inform the Director of the Office of Nuclear Reactor Regulation in writing when the reactor is and can be maintained in a safe and stable condition so as to prevent any significant risk to public health and safety. Within 30 days after the licensee informs the Director that the reactor is in this condition, or at such earlier time as the licensee may elect or the Director may for good cause direct, the licensee shall prepare and submit a cleanup plan for the Director's approval. The cleanup plan must identify and contain an estimate of the cost of each cleanup operation that will be required to decontaminate the reactor sufficiently to permit the licensee either to resume operation of the reactor or to apply
 
to the U.S. Nuclear Regulatory Commission (NRC) for authority to decommission the reactor and to surrender the license voluntarily.
The NRC topical report program is governed by several relevant regulations. Title 10 of the Code of Federal Regulations (10 CFR) Part 2, Agency Rules of Practice and Procedure, Part 21, Reporting of Defects and Noncompliance, Part 50 Domestic Licensing of Production and Utilization Facilities and Part 170, Fees for Facilities, Materials, Import and Export Licenses, and other Regulatory Services under The Atomic Energy Act of 1954, As Amended, describes the formal procedures that the NRC uses to implement its topical report program.
A topical report is a document that addresses a technical topic related to nuclear power plant safety, which the industry submits for review and approval by the NRC before publishing the report for use in the licensing process by other nuclear power plant licensees.
Applicants submit a report that addresses a specific safety-related topic, i.e.,
component design regarding a U.S. nuclear power plant that requires a safety evaluation by the agency. An applicant seeking a topical review must submit the report to the NRC by letter, in accordance with LIC-500, Topical Report Process (ADAMS Accession Number ML13158A296).
 
GUIDANCE DOCUMENTS FOR INFORMATION COLLECTION REQUIREMENTS CONTAINED IN APPLICATIONS 10 CFR PART 50 SECTION 2 50.30, 55(b) & (d) - Filing Application; Decommissioned Plants 50.54(bb); License Amend. 50.59(c), 50.90, 50.91(a), (b);
License Transfers 50.80(b); NRC Notification, 50.74; 50.33 Early Site Permits 50.33(a)-(d), (j);
50.33 Non-Power Operating License; 50.33 Standard Design Certification 50.33(a)-(d);
50.33 Combined OL 50.33(a)-(d), (g) 3150-0011 Title                                          Accession number Regulatory Guide 1.21, Rev. 2, Measuring,          ML091170109 Evaluating, and Reporting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants, Regulatory Guide 1.174, An Approach for            ML100910006 Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis Regulatory Guide 1.177, An Approach for            ML100910008 Plant-Specific, Risk-Informed Decisionmaking:
Technical Specifications Regulatory Guide 1.200, An Approach for            ML090410014 Determining the Technical Adequacy of Probabilistic Risk Assessment Results for Risk-Informed Activities Regulatory Guide 4.1, Rev. 2, Programs for          ML091310141 Monitoring Radioactivity in the Environs of Nuclear Power Plants.
LIC-500, Topical Report Process                    ML13158A296 DG-1362 for RG 1.200 Revision 3,                    ML19308B636 Acceptability of Probabilistic Risk Assessment Results for Risk-Informed Activities Regulatory Guide 1.70, Revision 3, Standard          ML011340122 Format and Content of Safety Analysis Reports for Nuclear Power Plants, LWR Edition.
Regulatory Guide 1.206, Revision 1,                  ML18131A181 Applications for Nuclear Power Plants NUREG-1537, Part 1, "Guidelines for                  ML042430055 Preparing & Reviewing Applications for Licensing of Non-Power Reactors, Format and Content."}}

Revision as of 11:56, 9 September 2021

OMB-3150-0011 Final 2021 Collection Renewal, 10 CFR Part 50 Domestic Licensing of Production and Utilization Facilities - Supporting Statement Section 2
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FINAL SUPPORTING STATEMENT FOR 10 CFR PART 50 APPLICATIONS SECTION 2 50.30, 55(b) & (d) - Filing Application; Decommissioned Plants 50.54(bb); License Amend. 50.59(c), 50.90, 50.91(a), (b); License Transfers 50.80(b); NRC Notification, 50.74; 50.33 Contents of applications; general information (Early Site Permits; Standard Design Certifications, Combined Licenses, Standard Design Approvals, Manufacturing Licenses, Construction Permits, Operating Licenses); 50.33(f) Financial Qualifications, 50.36,50.36A, 50.36B & Appendix I, Technical Specifications; 50.34(c) & (d) &

50.54(p), Security; 50.35(b), Periodic Reports; 50.34(w)(3) & (4), Property Insurance Damage Insurance 3150-0011 ABSTRACT The U.S. Nuclear Regulatory Commission (NRC) is authorized by Congress to have responsibility and authority for the licensing and regulation of nuclear power plants, research reactors and testing facilities (also known collectively as research and test reactors), fuel reprocessing plants and other utilization and production facilities licensed pursuant to the Act. To meet its responsibilities, the NRC conducts a detailed review of all applications for licenses to construct and operate such facilities. The purpose of the detailed review is to ensure that the proposed facilities can be built and operated safely at the proposed locations, and that all structures, systems and components important to safety will be designed to withstand the effects of postulated accident conditions, without undue risk to the health and safety of the public.

Under 10 CFR Part 50, before a company or other entity can build a production or utilization facility at a particular site, it must obtain a construction permit from the NRC. Subsequently, an operating license must be obtained from the NRC before an applicant can operate the facility. The decision by the NRC as to whether to approve an application for a construction permit or an operating license is based largely on the NRC staff's detailed review of the information provided as part of an application. Information provided by the applicant as part of the application is crucial to the licensing process as it provides the NRC with the information it needs to make a decision with regard to the proposed facility's impact on the public's health and safety and the environment.

The Commission issues an operating license or construction permit, with appropriate conditions and limitations (including technical specifications), after determining that an application for a license meets certain standards and requirements. Licensees must maintain records and prepare reports to demonstrate their fulfillment of regulatory requirements. The information collection requirements in this section include:

  • filing application for a license or combined license which includes both general (applicant name; type of business; radiological emergency response plans) and technical information (preliminary or final safety analysis report; descriptions of the equipment and systems);
  • submitting technical specifications with administrative controls. Administrative controls are

the provisions relating to organization and management, procedures, recordkeeping, review and audit, and reporting necessary to ensure operation of the facility in a safe manner;

  • periodic reports of the progress and results of research and development programs designed to resolve safety questions and reports on the amount and sources of property damage/accident recovery insurance; and

These regulations affect 89 licensees for operating nuclear power plants, 31 non-power production and utilization facilities, 15 combined operating license holders/applicants and 29 power plants that are currently being decommissioned. Licensees may voluntarily submit a request for an exemption to the Commission and maintain a record of that request.

Licensees may voluntarily submit a request for an exemption (See Section 6) to the Commission and maintain a record of that request.

A. JUSTIFICATION

1. Need for Collection of Information The information is needed in order to determine licensee compliance with the regulations set forth in 50.30, 55(b) & (d); 50.33a & Appendix L; 50.54(bb); 50.59(c),

50.90, 50.91(a), (b); 50.80(b); 50.74; 50.33; 50.36,50.36A, 50.36B & Appendix I,;

50.34(c) & (d) & 50.54(p); 50.35(b), 50.34(w)(3) & (4). Details of these regulations can be found at the end of this supporting statement in Description of Requirements.

2. Agency Use and Practical Utility of Information Applicants or licensees requesting approval to construct or operate utilization or production facilities are required by the Atomic Energy Act of 1954, as amended (the Act), to provide information and data that the NRC may determine necessary to ensure the health and safety of the public.

The NRC uses the records and reports required in this part to ascertain that licensees licensing the design, construction, operation, and decommissioning of commercial nuclear power plants and other nuclear facilities programs are adequate to protect public health and minimize danger to life and property and that licensees personnel are aware of and follow up on the information and steps needed to perform licensed activities in a safe manner. The reports and recordkeeping requirements allow NRC to determine whether to take actions, such as to conduct inspections or to alert other licensees to prevent similar events that may have generic implications.

3. Reduction of Burden Through Information Technology There are no legal obstacles to reducing the burden associated with this information collection. The NRC encourages respondents to use information technology when it would be beneficial to them. The NRC has issued Guidance for Electronic

Submissions to the NRC which provides direction for the electronic transmission and submittal of documents to the NRC. Electronic transmission and submittal of documents can be accomplished via the following avenues: the Electronic Information Exchange (EIE) process, which is available from the NRC's Electronic Submittals Web page, by Optical Storage Media (OSM) (e.g. CD-ROM, DVD), by facsimile or by e-mail. It is estimated that approximately 45% of the responses are filed electronically.

4. Effort to Identify Duplication and Use Similar Information No sources of similar information are available. There is no duplication of requirements.
5. Effort to Reduce Small Business Burden Not applicable.
6. Consequences to Federal Program or Policy Activities if the Collection is Not Conducted or is Conducted Less Frequently If the information is not collected, NRC will not be able to assess whether licensees are operating within the specific safety requirements applicable to the licensing, constructing, and operating activities for nuclear power reactors; research and test reactors; and other production and utilization facilities.

The information and required frequency from licensees that seek to construct and operate nuclear power reactors, research and test reactors; and other production and utilization facilities is essential to NRCs determination of whether the applicant has adequate equipment, training, funds and experience throughout the life of the licensee to protect the public health and safety.

7. Circumstances which Justify Variation from OMB Guidelines 10 CFR 50.74 requires that licensees notify the NRC within 30 days of any change in the status of licensed reactor operators or senior operators. The variation is necessary to be sure that temporarily or permanently replaced licensed or senior reactor operators are immediately staffed by qualified personnel.

A few special reports, such as the Licensee Event Reports, required by 10 CFR 50.36(c), 10 CFR 50.72, and 10 CFR 50.73, the Post Accident Monitoring Report (when required), and the Steam Generator Tube Inspection Report, are required in fewer than 30 days to ensure that the NRC promptly responds to situations with the potential to seriously impact public health and safety (also see the Section 4 Supporting Statement). Many of the records involved with this information collection are retained longer than 3 years, some for the life of the plant, to establish patterns or base-line performance to anticipate and assess future trends. These variations are deemed necessary to ensure that the health and safety of the public will not be adversely affected by the operation of the plant.

10 CFR 50.54(w)(4)(ii) requires licensees to provide written notification when the reactor is and can be maintained in a safe and stable condition. This notification could

occur in less than 30 days of the event, at which time licensees are expected to provide the required notification.

This notification is necessary to provide the NRC with information to monitor cleanup and to begin allowing the release of insurance proceeds from the decontamination priority and also used for non-cleanup purposes.

8. Consultations Outside the NRC Opportunity for public comment on the information collection requirements for this clearance package was published in the Federal Register on February 19, 2021, (86 FR 10360). Additionally, NRC staff contacted five stakeholders via email. The stakeholders were new, operating and research and test reactor owner licensee representatives and interested stakeholders from Duke Energy Progress, LLC, Kairos Power, Southern Nuclear Operating Co., Washington State University and X-Energy.

The NRC received one out-of-scope comment as a result of the FRN. No additional responses or comments were received as a result of the FRN or the staffs direct solicitation of comment.

9. Payment or Gift to Respondents Not applicable.
10. Confidentiality of Information Confidential and proprietary information is protected in accordance with NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).
11. Justification for Sensitive Questions This regulation does not request sensitive information.
12. Estimated Industry Burden and Burden Hour Cost The total estimated cost for information collection requirements in this section is estimated to be 682,975 hours0.0113 days <br />0.271 hours <br />0.00161 weeks <br />3.709875e-4 months <br /> at a cost of $ 190,550,025 (682,975 hours0.0113 days <br />0.271 hours <br />0.00161 weeks <br />3.709875e-4 months <br /> x $279/hr).

Total Burden and Responses Section 2 Hours Responses Reporting 457,342 2,152 Recordkeeping 225,633 164 TOTAL 682,975 2,316 Detailed burden estimates are included in the supplemental burden spreadsheet titled, Table 1 - Summary of Supporting Statements. The $279 hourly rate used in the burden estimates is based on the Nuclear Regulatory Commissions fee for hourly rates as noted in 10 CFR 170.20 Average cost per professional staff-hour. For more

information on the basis of this rate, see the Revision of Fee Schedules; Fee Recovery for Fiscal Year 2020 (85 FR 37250, June 19, 2020).

13. Estimate of Other Additional Costs The quantity of records to be maintained is roughly proportional to the recordkeeping burden and therefore can be used to calculate approximate records storage costs.

Based on the number of pages maintained for a typical clearance, the records storage cost has been determined to be equal to .0004 times the recordkeeping burden cost.

Therefore, the storage cost for this clearance is estimated to be $25,180 (225,633 recordkeeping hours x $279 x .0004).

14. Estimated Annualized Cost to the Federal Government The staff has developed estimates of annualized costs to the Federal Government related to the conduct of this collection of information. These estimates are based on staff experience and subject matter expertise and include the burden needed to review, analyze, and process the collected information and any relevant operational expenses.

The annualized estimated cost to the government is $28,444,887 (101,953 hours0.011 days <br />0.265 hours <br />0.00158 weeks <br />3.626165e-4 months <br /> x

$279) as shown on the attached Summary Table.

15. Reasons for Changes in Burden or Cost The burden and number of responses have changed as described in the tables below:

Burden change 2018 Current Change estimates submission Reporting 440,901.7 457,342 16,440.3 Recordkeeping 230,820.5 225,633 -5,187.5 Third Party 0.0 0 Disclosure 0 Total 671,722.2 682,975 11,252.8 Change in Responses 2018 Current Change estimates submission Reporting 2,152 2,152 0 Recordkeeping 153 164 11.00 Third Party 0 0 0 Disclosure Total 2,305.3 2,316 11.00 Overall, for this section, the changes are attributed the increase in certificate holders and decommissioning plants, and a decrease in operating reactors and sites.

The largest increase in burden is due to an increase in the estimated number of license amendments under 50.59(c), 50.90, 50.91(a), and (b). The number of estimated license amendments increased from 918 to 984. At 313 hours0.00362 days <br />0.0869 hours <br />5.175265e-4 weeks <br />1.190965e-4 months <br /> per license amendment, this resulted in an increase of 20,658 hours0.00762 days <br />0.183 hours <br />0.00109 weeks <br />2.50369e-4 months <br />. In addition, 6,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> of burden was added for license amendments related to topical reports.

The largest decrease in burden is associated with technical specifications for operating power reactors. Due to a change in the number of operating reactors from 94 to 89, the estimated burden for this section decreased from 195,520 to 185,120, a decrease of 10,400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br />. The burden for technical specifications for shutdown reactors increased by 3,120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />. The burden for technical specifications is lower for a shutdown reactor (208 hours0.00241 days <br />0.0578 hours <br />3.439153e-4 weeks <br />7.9144e-5 months <br /> rather than 2080 hours0.0241 days <br />0.578 hours <br />0.00344 weeks <br />7.9144e-4 months <br />); therefore, the overall burden for technical specifications was a net decrease.

In addition, the burden for 50.34(c) & (d) & 50.54(p) that is covered under 10 CFR 73.67 (approved by OMB under Clearance No. 3150-0002) has been removed, which reduced the responses by 76.

16. Publication for Statistical Use The information being collected is not expected to be published for statistical use.
17. Reason for Not Displaying the Expiration Date The recordkeeping and reporting requirements for this information collection are associated with regulations and are not submitted on instruments such as forms or surveys. For this reason, there are no data instruments on which to display an OMB expiration date. Further, amending the regulatory text of the CFR to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.
18. Exceptions to the Certification Statement None.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable.

Appendix A - Description Requirements Applications 10 CFR 50.30 This section provides for the filing of an application for early site permits; standard design certifications, combined licenses, standard design approvals, manufacturing licenses, construction permits, and operating licenses which includes both general and technical information. General information is covered under Section 50.33, and technical information is covered under Section 50.34. Provisions pertaining to technical information submitted in applications currently in Section 50.34 for early site permits, standard design certifications, and combined licenses are being amended to move these requirements to, and cover the burden in, Part 52. The general information required by Section 50.33 will remain in Part 50. Section 50.30(f) also requires that an Environmental Report (ER) be submitted pursuant to Part 51. The information collection burden associated with the ER is covered by a separate OMB clearance for Part 51 (3150-0021) and, therefore, no environmental burden is included for Section 50.30.

10 CFR 50.33. This section requires each application to provide general information such as: applicant name, address, type of business (partnership or corporation),

citizenship, to identify the class of license, how the license will be used, the time period for the license, a list of other related licenses and provide details about the applicant's financial qualifications and emergency response plans.

10 CFR 50.33(f) This subsection requires the applicant to submit information demonstrating the financial qualification of the applicant to carry out, in accordance with regulations in this chapter, the activities for which the permit or license is sought.

Under subsection 50.33(f)(5) the Commission may request an established entity or newly formed entity to submit additional or more detailed information respecting its financial arrangements and status of funds if the Commission considers this information appropriate. This may include information regarding a licensees ability to continue the conduct of the activities authorized by the license and to decommission the facility.

10 CFR 50.33(g). This section of 10 CFR 50 requires that the applicant for an operating license submit state and local government radiological emergency response plans. The plans shall define the Emergency Planning Zone (EPZ) for the plume exposure pathway and the ingestion pathway. Generally, with the nuclear facility located at the center, the plume exposure pathway for the EPZ will cover an area with a radius of approximately 10 miles, and the ingestion pathway will cover an area with a radius of approximately 50 miles. The exact size and configuration of the EPZ will be determined in relation to the local emergency response needs and capabilities as they are affected by such conditions as demography, topography, access routes and jurisdictional boundaries.

10 CFR 50.54(bb). This section requires that for operating nuclear power reactors, the licensee shall, within 2 years following permanent cessation of operation of the reactor or 5 years before expiration of the reactor operating license, whichever occurs first, submit written notification to the Commission for its review and

preliminary approval of the program by which the licensee intends to manage and provide funding for the management of all irradiated fuel at the reactor following permanent cessation of operation of the reactor until title to the irradiated fuel and possession of the fuel is transferred to the Secretary of Energy for its ultimate disposal in a repository. Final Commission review will be undertaken as part of any proceeding for continued licensing under 10 CFR 50 or 10 CFR 72. The licensee must demonstrate to the NRC that the elected actions will be consistent with NRC requirements for licensed possession of irradiated nuclear fuel and that the actions will be implemented on a timely basis. Where implementation of such actions requires NRC authorizations, the licensee shall verify in the notification that submittals for such actions have been or will be made to the NRC and shall identify them. A copy of the notification shall be retained by the licensee as a record until expiration of the reactor operating license. The licensee shall notify the NRC of any significant changes in the proposed waste management program as described in the initial notification.

10 CFR 50.55(b). This section specifies that if the proposed construction or modification of a facility is not completed by the latest completion date specified in the construction permit, the permit shall expire and all rights there under shall be forfeited. However, if good cause can be shown by the applicant, the Commission may extend the completion date for a reasonable period of time. The Commission will recognize, among other things, developmental problems attributable to the experimental nature of the facility or fire, flood, explosion, strike, sabotage, domestic violence, enemy action, an act of the elements, and other acts beyond the control of the permit holder, as a basis for extending the completion date. No completion date extensions are expected during this clearance period. Thus, the relevant burden is zero.

Pursuant to 10 CFR 50.55(d), at or about the time of completion of the construction or modification of the facility, the applicant must file any additional information needed to bring the original application for license up to date, and must file an application for an operating license or an amendment to an application for a license to construct and operate the facility for the issuance of an operating license, as appropriate, as specified in 10 CFR 50.30(d).

10 CFR 50.59(c), 50.90, 50.91(a) and (b). These sections are applicable for amendment of licenses to operating nuclear power plants, research and test reactors, and other production and utilization facilities, amendment of licenses to permanently shut down nuclear power and research and test reactors and other production and utilization facilities and amendments to combined licenses, manufacturing licenses, early site permits and construction permits. 10 CFR 50.59(c) requires the holder of a license authorizing operation of a production or utilization facility who desires to make a change to the facility or procedures as described in the FSAR or to conduct tests or experiments not described in the FSAR to submit an application for amendment of the license pursuant to 10 CFR 50.90 if the change, experiment, or test does meet certain criteria or a change to the TS is required. 10 CFR 50.59 (d)(2) requires the licensee to submit a report of these changes and the corresponding evaluations at intervals not to exceed 24 months. Amendments to permits and licenses may also be submitted by holders of

construction permits, early permits, manufacturing licenses, and combined licenses (prior to the operation of the nuclear power plant).

10 CFR 50.90 requires the application for amendment of the license or permit to be filed with the Commission, fully describing the changes and following as far as applicable in the form prescribed for original applications.

The application for amendment of the license or permit enables the staff to evaluate any changes made at the facility or any new information concerning the facility that may potentially affect the safety of the facility and consequently the health and safety of the public.

Under 10 CFR 50.91(a)(1) and (b)(1), a licensee requesting an amendment must provide to the NRC and the State in which its facility is located, the amendment application and an analysis concerning the issue of no significant hazards consideration. NRC needs licensees' and permit holders analyses to quickly make and publish for public comment its proposed determination about no significant hazards consideration; the States need licensees' and permit holders analyses in order to quickly consult with the NRC.

On July 19, 1995, the Commission published in the Federal Register (60 FR 36953) its final rule on TS for nuclear power reactors. The rule codified the criteria identified in the final policy statement for determining the content of TS. A major benefit of the rule involves the reduction in the number of safety functions controlled by TS (limiting conditions for operation) by applying the criteria. The rule ensures that any changes to the most safety significant features will require prior review and approval by NRC. The safety functions that do not satisfy the criteria can be relocated to licensee-controlled documents and changed pursuant to 10 CFR 50.59.

The burden on licensees and the NRC can be reduced by relocating such provisions or, for power reactor licensees, completely converting the existing TS to the improved Standard Technical Specifications (STS). Recordkeeping and reporting requirements for revisions that do not require an amendment are covered in Section 5 of this clearance submittal.

10 CFR 50.80(b) This section specifies that an application for a transfer of a license shall include as much of the information described in 10 CFR 50.33 and 50.34 with respect to the identity and technical and financial qualifications of the proposed transferee as would be required by those sections if the application were for an initial license. 10 CFR 50.80(b) also specifies that the Commission may require additional information, such as data with respect to proposed safeguards against hazards from radioactive materials, and the transferee's qualifications to protect against such hazards.

The requirements described above are needed to assure the transferee's financial capability to run the facility safely and to ensure the transferee's technical capability to properly and safely operate the facility in a way that protects the health and safety of the public.

Procedures for aircraft impact and beyond-design basis threat The Power Reactor Security Final Rule, approved by OMB in April 2009, established and updated generically applicable security requirements similar to those previously imposed by Commission orders issued after the terrorist attacks of September 11, 2001. This rule added sections 50.54(hh) (1)&(2):

10 CFR 50.74 This section requires licensees of nuclear power facilities to notify the NRC within 30 days of a change in status of a licensed reactor operator or senior operator. The NRC needs to know if operators have been permanently reassigned, terminated, or have undergone permanent disability, or illness as required by 10 CFR 55.25, to ensure that a qualified replacement has been assigned. (Note that notifications involving 10 CFR 55.25 are cleared under OMB Clearance No. 3150-0024.)

10 CFR 50.36 requires licensees to maintain technical specifications with administrative controls. Administrative controls are the provisions relating to organization and management, procedures, recordkeeping, review and audit, and reporting necessary to ensure operation of the facility in a safe manner. These reporting and recordkeeping requirements are set forth in the Technical Specifications (TS), Appendix A to the operating license for each facility license.

Pursuant to 10 CFR 50.36b, environmental reporting and recordkeeping requirements are set forth in Appendix B to the operating license for each facility license or in each licensees environmental protection plans. (A few facilities have a single appendix that contains the combined aspects of both Appendices A and B).

10 CFR 50.36(a) requires each applicant for a license authorizing operation of a production or utilization facility to include in its application proposed TS. A summary statement of the bases or reasons for such specifications, other than those covering administrative controls, shall also be included in the application.

10 CFR 50.36(b) requires each license authorizing operation of a production or utilization facility to include TS. The TS are derived from the analyses and evaluations included in the safety analysis report, and amendments thereto, submitted pursuant to 10 CFR 50.34.

10 CFR 50.36(c) specifies that limiting conditions for operations (LCO) are the lowest functional capability or performance levels of equipment required for safe operation of a facility. When an LCO of a nuclear reactor is not met, the licensee shall shutdown the reactor or follow any remedial action permitted by the technical specifications until the condition can be met. A completion time (CT) is the duration for which a licensee may continue to operate when it does not meet the requirements for lowest functional capability. Licensees can use PRA models acceptable to the NRC to estimate CTs. Those licensees shall submit reports to NRC if their PRA models incorporate newly developed methods.

10 CFR 50 Appendix I consists of numerical guides for design objectives and limiting conditions for plant operation to meet the criterion "as low as is reasonably achievable" for radioactive material in light-water-cooled reactor effluents.

Section 50.34(c)(3) requires that each plan must describe how the applicant will meet the requirements of 10 CFR 73 (and 10 CFR 11, if applicable, including the identification and description of jobs as required by 10 CFR 11.11(a), at the proposed facility). The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with the requirements of 10 CFR 11 and 10 CFR 73, if applicable. 10 CFR 73.67 prescribes requirements for the establishment and maintenance of a physical protection system which will have capabilities for the protection of SNM at fixed sites and in transit and for plants in which SNM is used.

10 CFR 11 prescribes criteria and procedures for determining eligibility for access to, or control over, certain quantities of SNM. The burden to provide this information is included in the OMB clearance for 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants (3150-0151).

Section 50.34(d)(1) requires that each application for a license to operate a production or utilization facility that will be subject to 10 CFR 73.50 and 10 CFR 73.60 must include a licensee SCP in accordance with 10 CFR 73 Appendix C. The SCP shall include plans for dealing with threats, thefts, and radiological sabotage as defined in 10 CFR 73. Four categories of information must be included in the applicant's SCP. These categories are specified in 10 CFR 73 Appendix C. First, the "Background" must identify and define the perceived dangers and incidents with which the plan will deal and the general way it will handle them. Second, the "Generic Planning Base" must define the criteria for initiation and termination of responses to safeguards contingencies together with the specific decisions, actions, and supporting information needed to bring about such responses. Third, the "Licensee Planning Base" must include the factors affecting contingency planning that are specific to the facility. The fourth category relates to a "Responsibility Matrix" that must include a detailed identification of the organizational entities responsible for each decision and action associated with specific responses to safeguards contingencies. The burden to provide this information is included in the OMB clearance for 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants (3150-0151).

Section 50.54(p)(1) requires that each licensee prepare and maintain SCP procedures in accordance with 10 CFR 73 Appendix C. Procedures must be established in order to aid execution of the detailed plan as developed in the "Responsibility Matrix" section of the SCP. The procedures must detail the actions to be taken and decisions to be made by each member or unit of the organization as planned in the "Responsibility Matrix." The procedures need not be submitted to the Commission for approval, but are inspected by the NRC staff on a periodic basis.

The burden to provide this information is included in the OMB clearance for 10 CFR Part 73, Physical Protection of Plants and Materials (3150-0002).

Section 50.54(p)(1) specifies that the licensee may make no change which would decrease the effectiveness of a PSP, or T&QP or CSP (required by 10 CFR 73.55 and 10 CFR 73.54) prepared pursuant to 10 CFR 50.34(c) or 10 CFR 73 or to the first four categories of information contained in the SCP prepared pursuant to 10 CFR 50.34(d) or 10 CFR 73, as applicable, without prior approval of the Commission. A licensee desiring to make such a change must submit an application for an amendment to the licensee's license pursuant 10 CFR 50.90.

Section 50.54(p)(2) also specifies that a licensee may make changes to the plans referenced in 10 CFR 50.54(p)(1) without prior approval if the changes do not decrease the safeguards effectiveness of the safeguards plan. The licensee, however, must maintain records of changes to the plans for a period of three years from the date of the change and must submit a report containing a description of each change within two months after the change is made.

Section 50.54(p)(3) requires the licensee to provide for the development, revision, implementation, and maintenance of its SCP. To this end, the licensee shall provide for a review at least every 12 months of the SCP by individuals independent of both security program management and personnel who have direct responsibility for implementation of the security program. All elements of the SCP must be reviewed at least once every 24 months.

Section 50.54(p)(4) requires that the review must include a review and audit of safeguards contingency procedures and practices, an audit of the security system testing and maintenance program, and a test of the safeguards systems along with commitments established for response by local law enforcement authorities. The results of the review and audit, along with recommendations for improvements, must be documented, reported to the licensee's corporate and plant management, and kept available at the plant for inspection for a period of three years. The burden to provide this information is included in the OMB clearance for 10 CFR Part 73, Physical Protection of Plants and Materials (3150-0002).

10 CFR 50.35(b) specifies that "The Commission may, in its discretion, incorporate in any construction permit provisions requiring the applicant to furnish periodic reports of the progress and results of research and development programs designed to resolve safety questions.

Under 10 CFR 50.54(w)(3), licensees are required to report annually on the amount and sources of this required insurance.

Under 10 CFR 50.54(w)(4)(i) and 10 CFR 50.54(w)(4)(ii), a licensee suffering an accident is required to submit a cleanup plan outlining the steps and costs needed to complete decontamination and cleanup and to allow release of the remaining insurance proceeds for non-cleanup purposes.

10 CFR 50.54(w)(4)(I) establishes a threshold of $100 million before a cleanup plan would be required.

10 CFR 50.54(w)(4)(ii) requires licensees to inform the Director of the Office of Nuclear Reactor Regulation in writing when the reactor is and can be maintained in a safe and stable condition so as to prevent any significant risk to public health and safety. Within 30 days after the licensee informs the Director that the reactor is in this condition, or at such earlier time as the licensee may elect or the Director may for good cause direct, the licensee shall prepare and submit a cleanup plan for the Director's approval. The cleanup plan must identify and contain an estimate of the cost of each cleanup operation that will be required to decontaminate the reactor sufficiently to permit the licensee either to resume operation of the reactor or to apply

to the U.S. Nuclear Regulatory Commission (NRC) for authority to decommission the reactor and to surrender the license voluntarily.

The NRC topical report program is governed by several relevant regulations. Title 10 of the Code of Federal Regulations (10 CFR) Part 2, Agency Rules of Practice and Procedure, Part 21, Reporting of Defects and Noncompliance, Part 50 Domestic Licensing of Production and Utilization Facilities and Part 170, Fees for Facilities, Materials, Import and Export Licenses, and other Regulatory Services under The Atomic Energy Act of 1954, As Amended, describes the formal procedures that the NRC uses to implement its topical report program.

A topical report is a document that addresses a technical topic related to nuclear power plant safety, which the industry submits for review and approval by the NRC before publishing the report for use in the licensing process by other nuclear power plant licensees.

Applicants submit a report that addresses a specific safety-related topic, i.e.,

component design regarding a U.S. nuclear power plant that requires a safety evaluation by the agency. An applicant seeking a topical review must submit the report to the NRC by letter, in accordance with LIC-500, Topical Report Process (ADAMS Accession Number ML13158A296).

GUIDANCE DOCUMENTS FOR INFORMATION COLLECTION REQUIREMENTS CONTAINED IN APPLICATIONS 10 CFR PART 50 SECTION 2 50.30, 55(b) & (d) - Filing Application; Decommissioned Plants 50.54(bb); License Amend. 50.59(c), 50.90, 50.91(a), (b);

License Transfers 50.80(b); NRC Notification, 50.74; 50.33 Early Site Permits 50.33(a)-(d), (j);

50.33 Non-Power Operating License; 50.33 Standard Design Certification 50.33(a)-(d);

50.33 Combined OL 50.33(a)-(d), (g) 3150-0011 Title Accession number Regulatory Guide 1.21, Rev. 2, Measuring, ML091170109 Evaluating, and Reporting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants, Regulatory Guide 1.174, An Approach for ML100910006 Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis Regulatory Guide 1.177, An Approach for ML100910008 Plant-Specific, Risk-Informed Decisionmaking:

Technical Specifications Regulatory Guide 1.200, An Approach for ML090410014 Determining the Technical Adequacy of Probabilistic Risk Assessment Results for Risk-Informed Activities Regulatory Guide 4.1, Rev. 2, Programs for ML091310141 Monitoring Radioactivity in the Environs of Nuclear Power Plants.

LIC-500, Topical Report Process ML13158A296 DG-1362 for RG 1.200 Revision 3, ML19308B636 Acceptability of Probabilistic Risk Assessment Results for Risk-Informed Activities Regulatory Guide 1.70, Revision 3, Standard ML011340122 Format and Content of Safety Analysis Reports for Nuclear Power Plants, LWR Edition.

Regulatory Guide 1.206, Revision 1, ML18131A181 Applications for Nuclear Power Plants NUREG-1537, Part 1, "Guidelines for ML042430055 Preparing & Reviewing Applications for Licensing of Non-Power Reactors, Format and Content."