Part 70 FINAL supporting statement

FINAL OMB SUPPORTING STATEMENT

FOR

10 CFR PART 70

DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

(3150-0009)

EXTENSION

Description of the Information Collection

The U.S. Nuclear Regulatory Commission (NRC, the Commission) regulations in Title 10 of the Code of Federal Regulations (10 CFR) Part 70 establish procedures and criteria for the issuance of licenses to receive title to, own, acquire, deliver, receive, possess, use, or transfer special nuclear material (SNM). Special nuclear material is defined by Title I of the Atomic Energy Act of 1954 as plutonium, or uranium enriched in the isotopes uranium-233 or uranium-235, but does not include source material. The definition includes any other material that the Commission determines to be SNM; however, the NRC has not declared any other material as SNM. The regulations are issued pursuant to the Atomic Energy Act of 1954, as amended, and Title II of the Energy Reorganization Act of 1974, as amended.

Under Part 70, applicants and licensees provide the following information:

• Applications for licensing actions, including descriptions of activities, facilities, equipment, procedures, material (amounts, forms, and quantities), and staff qualifications (experience and training),

• Plans (e.g., emergency plan, physical protection plan, fundamental nuclear material control plan, etc.),

• Verbal and Written Reports (e.g., notification of significant events, periodic monitoring results, etc.).

Licensees maintain records of changes to the license application, site, procedures, programs and plans. In addition, they must track and label their sources.

1. JUSTIFICATION

1. Need for and Practical Utility of the Information Collection

The information included in the applications, reports and records is reviewed by the NRC staff to assess the adequacy of the applicant's physical plant, equipment, organization, training, experience, procedures and plans for protection of public health and safety and the common defense and security.

Special nuclear material includes several isotopes of uranium and plutonium that are defined as "strategic special nuclear material" due to their potential use. To ensure the safety of the public and the security of the Nation, the NRC regulates Material Control and Accounting programs that are maintained by facilities licensed to possess these materials.

The NRC review and the findings derived therefrom form the basis for the NRC licensing decisions related to SNM. Information concerning the requirements imposed by specific sections is provided below.

2. Agency Use of the Information

The license applications that Part 70 requires applicants and licensees to submit are used to determine if the applicant has committed to maintain an adequate program to handle licensed material safely. There are many requirements for safety programs, but they fall into three general categories: (1) the applicant is qualified by reason of training and experience to use the licensed material, (2) the applicant's proposed equipment and facilities are adequate, and (3) the applicant's proposed procedures are adequate.

The records that Part 70 requires the licensees to maintain are reviewed during inspections and other site visits to evaluate compliance with the NRC safety and safeguards requirements for possession and use of SNM.

The records of receipt, transfer, and disposal of SNM are reviewed by the NRC inspectors to determine that licensees have confined their possession and use of SNM to the locations, purposes, receipt, and quantities authorized in their licenses.

Reports of significant events are used by the agency to evaluate actions taken to protect health and minimize danger to life or property. They are also used to determine the need for action by the agency to protect public health and safety, the common defense and security, and the environment.

Reports of monitoring results (e.g., effluent monitoring reports, environmental monitoring reports, etc.) are used to verify that the licensed activities are complying with requirements to protect public health and safety, and the environment.

3. Reduction of Burden Through Information Technology

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. Electronic submissions under Part 70 are transmitted through the EIE process.

Certain reports, such as transaction reports and inventory reports, are produced by some licensees using automated information technology. However, because of the types of information and the infrequency of submission, the applications and other reports may not lend themselves readily to the use of automated information technology for submission. It is estimated that 90 percent of these responses are filed electronically.

Approximately 95 percent of annual updates to the licensees’ integrated safety analysis are submitted electronically. Security plan updates are submitted in hard copy form for security reasons.

It is estimated that approximately 90 percent of the overall responses to Part 70 information collections 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

The NRC staff estimates that approximately one percent of respondents are small businesses; however, since the health and safety consequences of improper handling or use of SNM are the same for large and small entities, it is not possible to reduce the burden on small businesses by less frequent or less complete reporting, recordkeeping, or accounting and control procedures.

6. Consequences to Federal Program of Policy Activities if the Collection is Not Conducted or is Conducted Less Frequently

If the information included in the applications, reports and records were not collected, the NRC staff would not be able to assess the adequacy of the applicant's physical plant, equipment, organization, training, experience, procedures and plans for protection of public health and safety and the common defense and security in order to make licensing and other regulatory decisions related to SNM.

Required reports are collected and evaluated on a continuing basis as events occur. Applications for new licenses are submitted only once. Applications for license amendments are submitted as needed. Applications for renewal of licenses are submitted if licensees wish to continue operating beyond the term of the license (5–40 years depending on the license). Information submitted in previous applications may be referenced without being resubmitted. The schedule for collecting the information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of the public health and safety.

7. Circumstances Which Justify Variation from OMB Guidelines

Contrary to the Office of Management and Budget (OMB) Guidelines in 5 CFR 1320.5(d), Paragraph 70.9(b) requires that licensees submit a notification to the NRC in less than 30 days from the date of identifying information having significant implications for the public health and safety or the common defense and security and which is not covered by other reporting requirements. The requirement to provide notification within 2 working days following the identification of the information is necessary to ensure that the NRC is made aware of significant safety information that may require prompt action to protect the public health and safety.

Paragraph 70.20b(f) requires that licensees notify the NRC in writing using a method identified in Paragraph 70.5(a) concerning transient shipments with scheduled stops at U.S. ports. Licensees shall also notify the NRC Headquarters Operations Center by telephone at least 2 days before commencement of the shipment or by telephone of scheduled changes greater than 6 hours. This prompt notification is needed to enable the NRC to ensure that sufficient protection will be provided for the material being transported.

Paragraph 70.20b(g) requires that persons generally licensed under Paragraph 70.20b making unscheduled stops at U.S. ports must immediately provide to the NRC the information required under Paragraph 70.20b(f). This immediate notification is needed to permit the NRC staff to ensure that the transportation plan for transient shipments of formula quantities of SNM with unscheduled stops at U.S. ports is sufficient to protect the material being transported.

Contrary to the OMB Guidelines in 5 CFR 1320.5(d), Paragraph 70.32(a)(9) requires that licensees submit a notification to the NRC in less than 30 days from the date of filing of a petition in bankruptcy. The requirement to provide notification promptly following the filing of the petition is necessary to ensure that the NRC is made aware of the bankruptcy so it may draw on decommissioning financial assurance instruments and take other actions needed to protect the public health and safety.

Paragraph 70.50(a) requires each licensee to notify the NRC as soon as possible but not more than 4 hours after discovery of an event that prevents immediate protective actions necessary to avoid exposure to radiation or radioactive material. This immediate notification is necessary to inform the NRC of serious incidents in licensed facilities or activities. The information will be used by the NRC to determine whether immediate response or corrective action is needed to protect public health and safety.

Paragraph 70.50(b) requires each licensee to notify the NRC within 24 hours after the discovery of an event involving unplanned contamination, safety equipment failures, personal injury to an individual with radioactive contamination of clothing or body, or fire or explosion. This notification is necessary to inform the NRC of serious incidents in licensed facilities or activities. The information will be used by the NRC to determine whether immediate response or corrective action is needed to protect public health and safety. Four hour and 24-hour notifications are to be followed by a written report within 30 days.

Paragraph 70.52(a) requires that a licensee report an accidental criticality to the NRC Operations Center within 1 hour of discovery. This immediate notification is necessary to promptly inform the NRC of particularly serious accidents at licensed facilities or activities. The information is evaluated by the NRC to determine whether any immediate response or corrective action may be necessary.

Paragraph 70.52(b) requires that notifications for accidental criticality must be reported to the NRC Operations Center via the Emergency Notification System if the licensee is a party to that system. If the Emergency Notification System is inoperative or unavailable, the licensee shall make the required notification via commercial telephonic service or other dedicated telephonic system or any method that will ensure that a report is received by the NRC Operations Center within 1 hour. This immediate notification is necessary to permit the NRC staff to determine whether to initiate prompt action in the event of accidental criticality.

Section 70.62 requires certain licensees to establish and maintain records that demonstrate that its safety program satisfies performance requirements of Section 70.61 and that sufficient records of failure are maintained. These records are needed to facilitate inspection of items relied on for safety and to confirm the licensee’s assumptions regarding the availability and reliability of items relied on for safety as originally evaluated in their safety program. Because a long performance history is needed to accurately evaluate reliability and maintenance performance and trends, these records are retained for the life of the facility. Section 70.74 and Appendix A to Part 70 require each licensee to notify the NRC within 1 hour of discovery of certain events, this immediate notification is necessary to inform the NRC of incidents with potentially severe consequences in licensed facilities of activities. The information will be used by NRC to determine whether immediate response or corrective

action is needed to protect public health and safety and to be prepared to respond to inquiries from the public and its representatives, the same justification applies to requiring licensees to notify the NRC as soon as possible but not more than 24 hours after discovery of certain events defined in Appendix A. This notification is necessary to inform the NRC of incidents with serious but less than severe consequences, or of the potential for serious consequences, in licensed facilities or activities. The information will be used by the NRC to determine whether immediate response or corrective action is needed to protect public health and safety and to be prepared to respond to inquiries from the public and its representatives. One-hour and 24-hour reports are to be followed by a written report within 60 days.

Retention periods for records range from three years to the termination of license, and retention periods are specified on table 3. For example, the records in section 70.32 permit the NRC regulatory staff to evaluate changes which a licensee has made, or proposes to make, in the material control and accounting and measurement control programs, the plan for physical protection of SNM in transit, and the physical security plan at a fixed site. They also provide a means of determining whether such changes involve a significant decrease in the effectiveness of the program or plan.

8. Consultations Outside the NRC

Opportunity for public comment on the information collection requirements for this clearance package was published In the Federal Register (FR) on November 21, 2023 (88 FR 81110). As part of the consultation process, five individual licensees representative of the fuel facility business line were selected and contacted specifically. No comments were received as a result of this consultation process. One comment letter from the Nuclear Energy Institute (NEI) was submitted as a result of the November FR notice (NRC Agencywide Documents Access Management System No. ML24023A039). The commenter provided a request that the reporting burden for eight requirements be increased.

Comment #1: For 70.32(c)(2), the commenter requested an increase in burden hours per response from 13.3 to 80 for making changes to the material control and accounting program.

NRC Staff response: The NRC staff agrees with the suggested 80 hours for this requirement (similar to the level of effort for physical security plan changes).

Comment #2: For 70.32(i), the commenter requested an increase in burden hours per response from 16 to 80 for making changes to the emergency plan.

NRC Staff response: The NRC staff agrees with the suggested 80 hours for this requirement (similar to the level of effort for physical security plan changes).

Comment #3: For 70.50(c)(1), the commenter requested an increase in burden hours per response from 4 to 24 for initial event reporting by telephone.

NRC Staff response: The NRC staff agrees with the suggested 24 hours for this requirement since it takes time to determine if an event is reportable (unplanned contamination and Appendix A included).

Comment # 4: For 70.50(c)(2), the commenter requested an increase in burden hours per response from 40 to 120 for the 30-day written event report.

NRC Staff response: The NRC staff agrees with the suggested 120 hours for this requirement.

Comment #5: For 70.55(b), the commenter requested an increase in burden hours per response from 20 to 80 for record availability for each inspection.

NRC Staff response: The NRC staff agrees with the suggested 80 hours for each inspection for this requirement. Recognizing that licensees typically have 8-10 inspections per year, NRC staff is also adjusting the responses per respondent from 2 to 8.

Comment #6: For 70.59, the commenter requested an increase in burden hours per response from 5 to 40 for effluent monitoring reports.

NRC Staff response: The NRC staff agrees with the suggested 40 hours for this requirement since the licensee has to analyze the data from the lab testing as well.

Comment #7: For 70.72(d)(3), the commenter requested an increase in burden hours per response from 40 to 300 for the annual update to the ISA [Integrated Safety Analysis].

NRC Staff response: The NRC staff agrees with the suggested 300 hours for this requirement since the source documents for the changes must also be updated and includes extensive review and approval process.

Comment #8: For 70.74, the commenter requested an increase in burden hours per response from 4 to 24 for the initial event report by telephone.

NRC Staff response: The NRC staff agrees with the suggested 24 hours for this requirement since it takes time to determine if an event is reportable (unplanned contamination and Appendix A included).

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 Paragraphs 9.17(a) and 2.390(b).

11. Sensitive Questions

None.

12. Estimated Burden and Burden Hour Cost

The NRC estimates an annual average of 240 licensees will respond to information collection requirements in Part 70 during the clearance period. The number of responses from each licensee will vary because the licenses authorize a wide variety of activities.

	Responses	Burden	Cost @$300/hr
Reporting	494	53,145	$15,943,500
Recordkeeping	240	5,635	$1,690,500
Third Party Disclosure	302	34	$10,200
TOTAL	1,036	58,814	$17,644,200

Detailed burden estimates are shown in supplemental document, “Part 70 Burden Spreadsheet.”

The $300 hourly rate used in the burden estimates is based on the NRC’s 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 2023 (88 FR 39120, June 15, 2023).

13. Estimate of Other Additional Costs

The NRC has determined that 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 0.0004 times the recordkeeping burden cost. Because the recordkeeping burden is estimated to be 5,635 hours, the storage cost for this clearance is $676 (5,635 hrs. x 0.0004 x $300/hr.).

14. Estimate of 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 estimated cost of NRC professional review and other efforts associated with the information collections in this clearance is $7,770,200 (25,900 staff hours x $300/hr.).

15. Reasons for Change in Burden or Cost

The overall burden has increased from 37,050 hours to 58,814 hours, an increase of 21,764 hours. The largest changes to the burden are as follows:

• As a result of public comments, the burden for eight requirements were adjusted to more accurately represent the resources expended by licensees to meet these requirements (see response #8 above). This increased burden estimates by more than 11,000 hours annually.

• A review of the burden estimates in the previous clearance package revealed that burden for existing requirements in 70.21 (application for a license to possess and use special nuclear material in a plutonium processing or fuel fabrication plant, or for a uranium enrichment facility license) was not included in the submission. Burden for 70.21 is included in this submission at 5,000 hours per application, with two anticipated applications annually. This increased the overall burden by 10,000 hours annually.

• Based on a review of recent data, fewer applications for licensing actions for existing licensees are anticipated in the upcoming clearance period. The number of annual applications under 70.22, 70.32(c)(1), 70.33, 70.34, 70.39(a), and 70.73 combined is expected to be 40 annually, compared to 60 annually in the last renewal submission. This change resulted in a burden decrease of 4,260 hours (decrease of 20 submissions x 213 hours per submission = 4,260 hours).

• Under 70.72, licensees must evaluate, implement, and track each change to the site, structures, processes, systems, equipment, components, computer programs, and activities of personnel.

• The NRC staff anticipates an increase in the number of changes requiring pre-approval under 70.72(d)(1). Two additional submissions annually at 800 hours per submission resulted in a burden increase of 1,600 hours.

• The staff also anticipates an increase in the number of changes not requiring pre-approval (but requiring an annual submission) under 70.72(d)(2). Two additional submissions at 600 hours per submission resulted in a burden increase of 1,200 hours.

The number of respondents increased from 200 to 240, resulting in additional increases in burden for a number of requirements. In addition, in the last renewal, the number of recordkeepers was calculated by summing the respondents column on the recordkeeping table, thus double-counting some respondents who were keeping records under multiple requirements. The current submission uses a de-duplicated count of recordkeepers. The number of responses decreased from 1,214 to 1,036, a decrease of 178, as a result of de-duplicating the number of recordkeeping responses. Each recordkeeper is now only counted once as a response.

In addition, there was an increase in professional cost from $278/hr. to $300/hr.

16. Publication for Statistical Use

None.

17. Reason for Not Displaying Expiration Date

The recordkeeping and reporting requirement 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.

Furthermore, 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.

2. Collection of Information Employing Statistical Methods

Statistical methods are not used in this collection of information.

APPENDIX A

DESCRIPTION OF INFORMATION COLLECTION REQUIREMENTS CONTAINED IN 10 CFR PART 70

DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL (3150-0009)

Paragraph 70.9(b) requires that an applicant or licensee notify the Commission of information which the licensee recognizes as having significant implications for the public health and safety or the common defense and security. This requirement applies only to information which is not covered by other reporting or updating requirements. The information must be provided within 2 working days.

This requirement is necessary because there may be some circumstances in which a licensee possesses some information which could be important to the protection of public health and safety or the common defense and security, but which is not otherwise required to be reported. The codification of this full disclosure requirement should not result in significant additional burdens on applicants or licensees. No formal program is required. What is expected is that licensees will maintain a professional attitude toward safety and that if some potential safety information is identified by the licensee, the information will be provided freely and promptly to the NRC so that the agency can evaluate it and act on it if necessary.

Paragraph 70.17(a) provides that the Commission may grant exemptions from the requirements of the regulations in Part 70 under specified conditions, upon the application of any interested person or on its own initiative. Applications under this section are examined by the NRC staff to determine whether the requested exemption is authorized by law and whether it will not endanger life or property or the common defense and security, and to determine if it is otherwise in the public interest.

Paragraph 70.19(c)(2) requires that a calibration or reference source, or the storage container, bear a label containing the model number, serial number, name of manufacturer or initial transferor, and a statement that the source is subject to a general license and the regulations of the NRC or an Agreement State, as well as a caution statement warning of the radioactive contents. This information needs to be available on the device so that in the event it is lost, anyone finding it will be aware of its hazards and whom to contact or, if there is an accident, the appropriate party may be contacted for vital information to determine the degree of possible hazard.

Paragraph 70.20a(d) requires that any person who possesses formula quantities of strategic SNM under the general license established in Paragraph 70.20a submit and receive NRC approval of a transportation security plan. The plan must outline the procedures that will be used to meet the requirements of specified sections of Part 73, including a plan for the selection, qualification, and training of armed escorts, or the specification and design of a specially designed truck or trailer as appropriate. This information will be reviewed by the NRC staff to ensure that the transportation plan is sufficient to protect the material being transported.

Paragraph 70.20a(e) requires that any person who possesses irradiated reactor fuel under the general license of Paragraph 70.20a must comply with the reporting requirements of Section 73.71. The reports will be used by the staff in the Regional

Office to ensure appropriate physical protection of irradiated reactor fuel in transport. In addition, in the event of an unaccounted-for shipment, suspected theft, unlawful diversion, radiological sabotage or event which significantly threatens or lessens the effectiveness of the physical protection of irradiated reactor fuel in transport, the NRC Operations Center must be notified so that appropriate contingency plans can be put into operation. The reporting requirements of section 73.71 have been previously cleared under the OMB No. 3150-0002, which should be referred to for burden, cost, and further supporting data.

Paragraph 70.20b(f) requires that persons generally licensed under Paragraph 70.20b who plan to carry transient shipments with scheduled stops at U.S. ports must notify the NRC in writing, 10 days in advance of shipment, of all scheduled stops in U.S. territory, arrival and departure times, the type of transport vehicle, the SNM contained in the shipment, the number and types of containers, the name and telephone number of the carrier's representative at each stopover location in U.S. territory, assurance of protection for shipments between countries that are not party to the Convention on Physical Protection of Nuclear Material, and a physical protection plan for implementing the requirements of Paragraph 70.20b(c), including use of armed personnel to protect the shipment while in a U.S. port. Licensees must also notify the NRC by telephone that such a notification has been sent, and must provide any changes to shipment itinerary. This information will be reviewed by the NRC staff to ensure that the transportation plan is sufficient to protect the material being transported.

Paragraph 70.20b(g) requires that persons generally licensed under Paragraph 70.20b making unscheduled stops at U.S. ports must immediately provide to NRC the information required under Paragraph 70.20b(f). This information will be reviewed by the Safeguards staff to ensure that the transportation plan for transient shipments of formula quantities of SNM with unscheduled stops at U.S. ports is sufficient to protect the material being transported.

Paragraph 70.21(a) specifies the methods for filing new license applications, the places to file the applications and the number of copies required.

Paragraph 70.21(f) requires that an application for a license to possess and use SNM material for processing and fuel fabrication, scrap recovery, or conversion of uranium hexafluoride, or for the conduct of any other activity which the Commission determines will significantly affect the quality of the human environment, must be filed nine months prior to construction and must be accompanied by an Environmental Report required under Part 51. The Environmental Report is reviewed by the NRC staff, and serves as a basis for the preparation by the NRC of an Environmental Impact Statement or an Environmental Assessment, which gives detailed consideration to the environmental impacts associated with construction and operation of a proposed facility or conduct of the activity and assesses impacts in terms of the available alternatives.

This information is necessary to permit the NRC to comply with the requirements of the National Environmental Policy Act of 1969. The burden and cost associated with this requirement are attributable to and have been previously cleared by OMB under Part 51, OMB No. 3150-0021, which should be referred to for further supporting information, burden and cost data.

Paragraph 70.21(g) requires that, in response to a written request from the Commission, an applicant for a license to possess and use more than one effective kilogram of SNM

shall file with the Commission the installation information described in section 75.11. This information is required by the NRC in order for the United States to comply with the United States/International Atomic Energy Agency (IAEA) Safeguards Agreement. IAEA Form N-71, "Design Information Questionnaire," is used to collect this information.

Section 75.11 has been previously cleared under OMB No. 3150-0055. IAEA Form

N-71 has been previously cleared under OMB No. 3150-0056. Those clearances should be referred to for further supporting information, burden and cost data.

Paragraph 70.21(h) requires that an application for a uranium enrichment facility contain an environmental report in accordance with Part 51.

Section 70.22 sets forth the requirements for the contents of applications.

Paragraph 70.22(a) specifies that each application must contain the full name, address, age, citizenship of applicant; need for SNM; period of time license requested; name, amount and specifications of SNM; technical qualifications; description of equipment and facilities; and description of proposed procedures. For certain activities, information regarding financial qualifications to engage in the activities is required. If required under Section 70.25 (discussed below) information on decommissioning financial assurance must be provided. Paragraph 70.22(b) requires a full description of the applicant’s program for control and accounting of SNM to show compliance with requirements of Part 74.

Paragraph 70.22(d) provides that the NRC may require further statements after the filing of the application and before expiration of the license to enable the NRC to determine whether the application should be granted or denied or whether a license should be modified or revoked. Such additional information is sometimes needed to clarify information submitted in the application, or to rectify deficiencies in proposed or existing programs for protection of the public health and safety, the common defense and security, or the environment.

Paragraph 70.22(e) requires each application to contain complete and accurate disclosure of all things required to be disclosed. Paragraph 70.22(f) requires each application for a plutonium processing and fuel fabrication plant to contain a description of safety assessment of design bases, quality assurance program, etc. Paragraph 70.22(g) requires certain applicants to submit transportation security plans and retain related records for three years. Paragraph 70.22(h) requires applicants authorized to possess certain materials to submit a physical security plan and retain related records for three years after the licensee last possessed the material. Paragraph 70.22(i) requires certain applicants to submit either: (1) an evaluation showing that the maximum dose to a member of the public offsite due to a release of radioactive materials would not exceed certain limits, or

(2) an emergency plan. Paragraph 70.22(j) requires certain applicants to submit a safeguards contingency plan and retain the plan as a record until the Commission terminates the license, and retain each change for three years. Paragraph 70.22(k) requires certain applicants to submit a physical security plan and requires those applicants to retain a copy of the physical security plan as a record as long as they possess material exceeding specified thresholds, and retain each change for 3 years. Paragraph 70.22(m) requires each application for a license to possess equipment capable of enriching uranium or operate an enrichment facility, and produce, possess, or use more than one effective kilogram of SNM, must contain a full description of the applicant's security program to protect against theft, and to protect against unauthorized viewing of classified enrichment equipment, and unauthorized disclosure of classified matter in

accordance with the requirements of 10 CFR Parts 25 and 95. Paragraph 70.22(n) requires that an application for a uranium enrichment facility involving the use of SNM include the applicant's provisions for public liability. This requirement allows the NRC to determine that the applicant meets the provisions of Public Law 101-575.

Paragraph 70.22(k) requires that any application for a licensee to possesses special nuclear material of moderate strategic significance or 10 kg or more of special nuclear material of low strategic significance must include a physical security plan. The physical security plan contains provisions for the security of the material regarding controlled access, surveillance, and in-transit requirements, as specified in 10 CFR 73.67(d)-(g).

Paragraph 70.24(a)(3) requires that licensees maintain emergency procedures for those areas subject to the criticality monitoring requirements of Paragraph 70.24(a). These procedures are designed to assure that all personnel will withdraw to an area of safety upon the sounding of a criticality alarm. Further, the procedures include requirements for periodic drills to familiarize personnel with the evacuation plans, designation of responsible individuals for determining the cause of the alarm and placement of radiation survey instruments in accessible locations for use in an emergency.

Section 70.25 sets forth the requirements for financial assurance and recordkeeping for decommissioning. Paragraphs 70.25 (a) and (b) specify which licensees may submit a certification of financial assurance in an amount prescribed in the regulation, and which licensees must submit a decommissioning funding plan. Paragraphs 70.25(c) and (d) specify the criteria for financial assurance and the prescribed amounts required for certification of financial assurance for decommissioning. Paragraph 70.25(e) specifies the information that each decommissioning funding plan must contain and requires licensees to submit updated information at intervals not to exceed three years.

Paragraph 70.25(f) specifies the information that a financial instrument must contain. Paragraph 70.25(g) requires that licensees keep records important to the safe and effective decommissioning of the facility until the license is terminated by the Commission and defines what information the Commission considers important.

The records and reports required by section 70.25 are necessary for the Commission to identify all locations where licensed activities were conducted and to verify the licensee has demonstrated those areas are suitable for unrestricted release.

Paragraph 70.32(a)(9) requires each licensee to notify the NRC by mail immediately following the commencement of a bankruptcy proceeding by or against the licensee. No action is required of a licensee unless and until a bankruptcy petition is filed.

Notification of the NRC in cases of bankruptcy would alert the Commission so that it may verify that licensed material remains secure and controlled. The information provided by the required notification would be used by the inspection and licensing staff, in consultation with legal and program staff, to evaluate the need for prompt NRC response or regulatory action. In addition, prompt notification allows the NRC to take timely and appropriate action in a bankruptcy proceeding to secure funds for decommissioning before funds are disbursed and become unavailable.

Paragraphs 70.32(c), (d), (e), (g), and (i)

The application, record keeping, and reporting requirements in section 70.32 permit the NRC regulatory staff to evaluate changes which a licensee has made, or proposes to make, in the material control and accounting and measurement control programs, the plan for physical protection of SNM in transit, and the physical security plan at a fixed site. They also provide a means of determining whether such changes involve a significant decrease in the effectiveness of the program or plan.

Paragraph 70.32(c) requires certain licensees to maintain and follow: (1) a program for the control of and accounting for SNM meeting the requirements in specified Sections of Parts 70 and 74, (2) a measurement control program meeting the requirements contained in specific sections of Parts 70 and 74, and (3) such other material control procedures as the Commission determines to be essential for the safeguarding of SNM. This section also provides that a licensee shall make no change to these plans which would decrease the effectiveness of the material control and accounting program or the measurement control program without the prior approval of the Commission. A licensee desiring to make such changes is required to submit an application for amendment to the license. A licensee making changes without prior Commission approval is required to maintain records of such changes and to inform the Commission of each change within a specified period of time after the change is made. Burden for records maintained under 70.32(c) are captured under the clearance for Part 74 (OMB clearance #3150-0123).

Paragraph 70.32(d) provides that a licensee required to have a plan for physical protection of material in transit shall make no change which would decrease the effectiveness of the plan without prior approval of the Commission. A licensee desiring to make such changes is required to submit an application to the Commission. A licensee making changes without prior Commission approval is required to inform the Commission of each change within a specified period of time after the change is made.

The licensee must retain a copy of the plan as a record as long as the licensee possesses the material and must retain changes to the plan for three years.

Paragraph 70.32(e) provides that a licensee required to have a physical security plan shall make no change which would decrease the effectiveness of its plan without prior approval of the Commission. A licensee desiring to make such a change is required to submit an application to the Commission. A licensee making changes without prior Commission approval is required to maintain records of such changes and to inform the Commission of each change within a specified period of time after the change is made.

Paragraph 70.32(g) provides that a licensee required to have a safeguards contingency plan shall make no changes which decrease the effectiveness of the plan without prior approval of the Commission. A licensee desiring to make such changes is required to submit an application to the Commission. A licensee making changes without prior Commission approval is required to maintain records of such changes and to inform the Commission of each change within a specified period of time after the change is made.

Paragraph 70.32(i) provides that a licensee required to have an emergency plan shall follow the plan approved by the Commission. Licensees may make changes to the approved plan without prior Commission approval only if such changes do not decrease the effectiveness of the plan. Licensees are required to submit a report of such changes within 6 months after the change is made. Licensees desiring to make changes that would decrease the effectiveness of the approved emergency plan are required to submit an application to the Commission for approval.

Section 70.34 requires that applications for license amendments shall specify how the license will be amended and the grounds for the amendment.

Section 70.36 states that no license may be transferred unless the Commission gives its consent in writing. An application for transfer of license must include: (1) the identity, technical and financial qualifications of the proposed transferee, and (2) financial assurance for decommissioning information required by section 70.25.

Paragraph 70.38(d) requires that each licensee notify the Commission in writing within 60 days of any of the following events: (1) the license has expired, (2) the licensee has decided to cease principal activities, (3) no principal activities have been conducted for 24 months at the site or, (4) no principal activities have been conducted for 24 months in any separate building or outdoor area suitable for unrestricted used. When this notification is made, the licensee shall either begin decommissioning or, submit within 12 months of notification a decommissioning plan if such a plan is required. This notification informs the Commission that the status of licensed activities has changed and establishes the start date for decommissioning activities that must be completed within specified time periods.

Paragraph 70.38(e) requires that, coincident with the notification required by 70.38(d), a licensee shall maintain all required financial assurances and shall adjust the amount of financial assurance to cover an updated cost estimate. The NRC reviews any request to change the amount of financial assurance to verify that the licensee will have adequate funds to complete decommissioning.

Paragraph 70.38(f) provides that a request to delay or postpone initiation of the decommissioning process may be granted if the Commission determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. Such requests must be submitted no later than 30 days before the notification required by Paragraph 70.38(d). The schedule for decommissioning will not commence until the Commission has made a determination on the request.

Paragraph 70.38(g)(1) requires that licensees submit a decommissioning plan if required by license condition or the decommissioning procedures and activities have not previously been approved by the NRC and the procedures could increase potential health and safety impacts to workers or the public. Submittal of the decommissioning plan is necessary for the NRC to evaluate any health and safety impacts.

Paragraph 70.38(g)(2) provides for approval of an alternate schedule for submittal of a decommissioning plan if the Commission determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

Paragraph 70.38(g)(4) requires that the decommissioning plan include: (1) a description of the current conditions of the site, building, or outdoor area to be decommissioned, (2) a description of planned decommissioning activities, (3) a description of methods to protect workers and the environment against radiation hazards during decommissioning, (4) a description of the planned final radiation survey, (5) an updated detailed cost estimate for decommissioning, comparison of that estimate with current funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning, (6) a description of the physical security plan and material control and accounting plan provisions in place during decommissioning, and (7) for decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay.

This information is needed by the Commission to more fully assess the risk of the environmental impact of decommissioning activities and to plan its involvement in decommissioning oversight and ultimate termination of the license or modification of the license to exclude the decommissioned areas. It is also needed to determine whether a delay in decommissioning warrants relief and is in the public interest. The burden for this requirement is included in the burden for Paragraph 70.38(g)(1) above.

Paragraph 70.38(h)(2) states when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning unless an alternate schedule has been approved.

Paragraph 70.38(i) provides for the NRC approval of an alternate schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate. The NRC will review the alternate schedule to determine if it is necessary for the effective conduct of decommissioning operations and presents no undue risk from radiation to public health and safety. Any burden associated with this section has been previously cleared by OMB under OMB 3150-0028.

Paragraph 70.38(j) contains the information that licensees must submit to the NRC as the final step in decommissioning. This includes certifying the disposition of all licensed material, on NRC Form 314 or equivalent, and submitting a report on the results of a survey of the premises. This information is necessary for the NRC to evaluate whether the authorized locations of use are suitable for release and the license is suitable for termination. This requirement has been approved by OMB under clearance number 3140-0028.

Paragraph 70.39(a) requires that an applicant for a specific license to manufacture or initially transfer calibration or reference sources containing plutonium, for distribution to general licensees, must submit information concerning the form and quantity of the plutonium, details of construction and design, method of incorporation and binding of the plutonium in the source, procedures for and results of prototype testing of sources, quality control procedures for manufacture of sources, description of labeling of sources or storage containers, and any additional information, including experimental studies and tests conducted. The information will be used by the NRC to determine whether the proposed manufacturing and distribution program is adequate.

Paragraph 70.39(b) requires that licensees affix a label to each source or storage container which must provide information as to safe use and storage, a statement that the source contains radioactive material and is subject to a general license and regulations of NRC or an Agreement State, and the model number, serial number, and name of the manufacturer or initial transferor of the source. This information is necessary to put persons handling the device on notice that it contains radioactive material and is subject to regulation, and so that if the source is lost or there is an accident, the appropriate party may be contacted for vital information to determine the degree of possible hazard.

Paragraph 70.42(c) requires that, before transferring SNM to a specific licensee or a general licensee who is required to register prior to receipt, the transferor must verify that the transferee's license authorizes receipt of the type, form, and quantity of SNM to be transferred.

Paragraph 70.42(d) specifies methods acceptable to the Commission for accomplishing the required verification, including:

1. The transferor may have in his possession, and read, a copy of the transferee's specific license or registration certificate.

2. The transferor may have a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of SNM to be transferred, specifying the license or registration number, issuing agency, and expiration date.

3. For emergency shipments, the transferor may accept oral certification from the transferee, provided it is confirmed in writing within 10 days.

4. The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or Agreement State licensing agency.

5. When other methods are not available, the transferor may obtain and record confirmation from the Commission or Agreement State licensing agency.

The information required by Paragraphs 70.42(c) and (d) is used by transferring licensees to provide assurance that the licensed SNM is being transferred to a person who is authorized to receive it. This verification serves as an additional check to prevent transfer of SNM to persons who may not have the facilities, training, experience, equipment or procedures necessary for the safe handling of the material. Records of these certifications will be reviewed by the NRC inspectors during periodic inspections to ensure that licensees have been complying with verification requirements.

Paragraph 70.50(a) requires each licensee to notify the NRC as soon as possible but not more than four hours after discovery of an event that prevents immediate protective actions necessary to avoid overexposure to or release of radioactive material. The information will be used by the NRC to determine whether immediate response or corrective action is needed to protect public health and safety.

Paragraph 70.50(b) requires each licensee to notify the NRC within 24 hours after the discovery of an event involving unplanned contamination, safety equipment failures, personal injury to an individual with radioactive contamination of clothing or body, or fire or explosion. Four hour and 24-hour notifications are to be followed by a written report within 30 days. The information will be used by the NRC to determine whether immediate response or corrective action is needed to protect public health and safety.

Paragraph 70.50(c)(1) requires that licensees make reports by telephone to the NRC Operations Center. To the extent that the information is available at the time of notification, the information provided in these reports must include the caller’s name, position title and call back telephone number; description of the event; external conditions affecting the event; actions taken by the licensee; status of the event; notifications related to the event; status of any press release related to the event; the probable cause of the event; corrective actions taken or planned; and, for licensees subject to Subpart H of the part, whether the event was identified and evaluated in the ISA.

Paragraph 70.50(c)(2) requires each licensee to submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if they contain the necessary information. These reports are used by the NRC to evaluate investigation results, to determine whether additional measures are necessary to protect the public health and safety, and to determine whether patterns exist that might indicate poor design, fabrication, or operation requiring corrective action.

Paragraph 70.51(a) requires that before license termination, licensees shall forward to the NRC Regional Office records of waste disposal of licensed material, results of measurements and calibrations used to evaluate radioactive effluents and records important to decommissioning a facility.

Paragraph 70.51(b) requires that if records identified in 70.51(a) are transferred or assigned in accordance with 70.32(a)(3), the licensee shall transfer the records to the new licensee and the new licensee becomes responsible for maintaining these records until license termination.

Paragraph 70.52(a) requires that a licensee shall notify the NRC Operations Center within one hour of discovery of any case of accidental criticality.

Paragraph 70.52(b) requires that the report required by Paragraph 70.52(a) must be made to the NRC Operations Center via the Emergency Notification System if the licensee is a party to that system. If the Emergency Notification System is inoperative or unavailable, the licensee shall make the require notification via commercial telephonic service or other method to ensure that a report is received by the NRC Operations Center within one hour.

Section 70.55(b) requires each licensee to make records available to the Commission for inspection. This requirement includes submitting or providing electronic access to certain documents in advance for inspection preparation activities. Other documents must be made readily available at the site for direct inspection activities.

Section 70.59 requires that each licensee authorized to possess and use SNM for processing and fuel fabrication, scrap recovery, conversion of uranium hexafluoride, or in a uranium enrichment facility, must submit semiannual reports to the NRC specifying the quantity of each of the principal radionuclides released to unrestricted areas in liquid and gaseous effluents during the previous six months of operation, and such other information as the Commission may require to estimate maximum potential annual radiation doses to the public resulting from effluent releases. The reports will be reviewed by the NRC and, if releases are significantly above design objectives, a determination will be made as to whether it may be necessary to direct the licensee to take action to reduce such effluents to protect public health and safety.

Paragraph 70.61(f) requires each licensee to establish a controlled area within which the licensee may permit persons to perform work not subject to the NRC licensing, in addition to radiation workers, provided the licensee either: (1) evaluates the risk to those persons and determines that it is no greater than the criterion for members of the general public, or

(2) ensures that those persons are aware of the risks to them from the potential accidents at the nuclear facility and have received appropriate training and access to the information.

Paragraph 70.62(a) requires that each licensee establish and maintain records that demonstrate that its safety program satisfies performance requirements of Section 70.61 and that sufficient records of failure are maintained. This record is needed to facilitate inspection of items relied on for safety and to confirm the licensee’s assumptions regarding the availability and reliability of items relied on for safety as originally evaluated in their safety program. Because a long performance history is needed to accurately evaluate reliability and maintenance performance and trends, these records should be retained for the life of the facility.

Paragraph 70.62(b) requires each licensee to complete and maintain a set of process safety information. This information is needed to enable the licensee to perform a proper ISA. Although not explicitly stated in the regulations, the process safety information used to support an ISA should be retained as long as the ISA that it supports is still valid.

Paragraph 70.62(c) requires each licensee or applicant to conduct and maintain an integrated safety analysis (ISA), that is of appropriate detail for the complexity of the process. The required content of the ISA is specified. An ISA Summary must be submitted for NRC approval. The information is needed to determine whether the ISA methods and results are adequate.

Paragraph 70.62(d) requires each applicant or licensee to establish management measures to provide continuing assurance of compliance with the performance requirements of Section 70.61. Management measures include: (1) configuration management, (2) maintenance, (3) training and qualifications, (4) procedures, (5) audits and assessments, (6) incident investigations, (7) records management, and (8) other quality assurance elements.

Paragraph 70.64(a) requires all applicants for licenses for new facilities to address baseline design criteria in the design of those facilities. Existing licensees must address these criteria in the design of new processes at existing facilities that require a license amendment, but are not required to retrofit existing facilities or processes. Licensees must maintain the application of these criteria unless an evaluation demonstrates that a given item is not relied on for safety or does not require adherence to the specified criteria. Quality assurance records of items relied on for safety must be maintained for the life of the facility.

Paragraph 70.65(a) states that in addition to the contents of license applications required by Section 70.22, each application for a license to possess a critical mass of SNM for use in the activities described in Section 70.60, must contain a description of the applicant’s safety program established under Section 70.62, including the integrated safety analysis summary and a description of management measures that ensure items relied on for safety will be available and reliable when needed to perform their safety function.

Paragraph 70.65(b) requires that the ISAs be submitted to the NRC, with a license or renewal or amendment application, and prescribes the content of the summary.

Paragraph 70.72(a) requires the licensee to establish a configuration management system to evaluate, implement and track changes. It also requires the licensee to develop written procedures that assure each change is adequately analyzed. The purpose of this requirement is to cause the impact of changes on health and safety to be

properly considered and to cause licensee personnel to get the information about changes needed for them to conduct their work safely.

Paragraph 70.72(d)(1) requires that for any changes that require pre-approval, the licensee shall submit an amendment request in accordance with Sections 70.34 and 70.65.

Paragraph 70.72(d)(2) requires that for any change that does not require pre-approval, the licensee shall submit a brief summary of all the changes within 30 days after the end of the calendar year during which the changes occurred.

Paragraph 70.72(d)(3) requires that for all changes affecting the ISA Summary, the licensee shall submit to the NRC annually, within 30 days after the end of the calendar year during which the changes occurred, revised pages of the ISA Summary. This information is needed to maintain accurate records and facilitate NRC oversight of the change control program.

Paragraph 70.72(e) requires that on-site documentation be promptly updated for changes covered by Section 70.72.

Paragraph 70.72(f) requires that each licensee maintain records of changes to its facility carried out under Section 70.72. These records must include a written evaluation that provides the bases for the determination that the changes do not require prior Commission approval. These records must be maintained until termination of the license in order that they be available to support any incident investigations that may arise in the future.

Section 70.73 lists the regulations that apply to license renewal applications.

Paragraph 70.74(a) requires each licensee subject to Subpart H of Part 70 to report all events described in Part 70, Appendix A, to the NRC Operations Center, including supplemental information as it becomes available. This information is needed to allow the NRC to evaluate the need for response actions and to allow the NRC to be able to respond to public inquiries about the incident. The provided information must include a description of the event and other information specified in Paragraph 70.50(c)(1). Each licensee also must provide reasonable assurance that reliable communication with the NRC Operations Center is available during each event.

Paragraph 70.74(b) requires each licensee who makes a report required by

Paragraph 70.74(a)(1) to provide a written report within 60 days of the initial report. The written report must contain the information prescribed in Paragraph 70.50(c)(2). This information is needed to permit future NRC review of the effectiveness of licensee actions and history of incidents.

Part 70, Appendix A specifies the events requiring reporting through one-hour and 24-hour reports (followed by a 60-day written report), as required by Section 70.74.

APPENDIX B

GUIDANCE DOCUMENTS ASSOCIATED WITH INFORMATION COLLECTIONS CONTAINED IN 10 CFR PART 70

DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL (3150-0009)

Guidance Document	Link
NUREG 1065: “Acceptable Standard Format and Content for the Fundamental Nuclear Material Control (FNMC) Plan Required for Low-Enriched Uranium Facilities.”	https://www.nrc.gov/reading-rm/doc- collections/nuregs/staff/sr1065/
NUREG-1280: “Acceptable Standard Format and Content for the Material Control and Accounting Plan Required for Strategic Special Nuclear Material.”	https://www.nrc.gov/docs/ML1325/ML13253A308.pdf
NUREG-1513: Integrated Safety Analysis Guidance Document	https://www.nrc.gov/docs/ML0114/ML011440260.pdf
NUREG-1520: “Standard Review Plan for Fuel Cycle Facilities License Applications”	https://www.nrc.gov/reading-rm/doc- collections/nuregs/staff/sr1520/
NUREG-1556: “Consolidated Guidance About Materials Licenses”	https://www.nrc.gov/reading-rm/doc- collections/nuregs/staff/sr1556/
NUREG-2159: Acceptable Standard Format and Content for the Material Control and Accounting Plan Required for Special Nuclear Material of Moderate Strategic Significance	https://www.nrc.gov/docs/ML1823/ML18236A394.pdf
Regulatory Guide (RG) 5.70: “Guidance for the Application of the Theft & Diversion Design Basis Threat in the Design, Development, and Implementation of a Physical Security Program that Meets CFR 73.45 and 73.46”	RG 5.70 contains classified information. Therefore, this RG is being withheld from public disclosure, but is available to those affected licensees and cleared stakeholders who qualify for access and have a demonstrated need to know.

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