This subpart applies to those construction and manufacturing activities authorized by a construction permit (CP), combined license (COL), manufacturing license (ML), or limited work authorization (LWA) issued under this part.

Each CP and ML issued under this part is subject to the terms and conditions in this section, and each COL issued under this part is subject to the terms and conditions in this section until the date that the Commission makes the finding under § 53.1452(g).

(a) Definitions. The definitions in § 21.3 of this chapter apply to this section.

(b) Posting requirements. (1) Each individual, partnership, corporation, dedicating entity, or other entity subject to the regulations in this section must post current copies of this section and the regulations in 10 CFR part 21; section 206 of the Energy Reorganization Act of 1974, as amended; and procedures adopted under these regulations. These documents must be posted in a conspicuous position on any premises within the United States where the activities subject to the license are conducted.

(2) If posting of these regulations or the procedures adopted under them is not practical, the licensee may, in addition to posting section 206 of the Energy Reorganization Act of 1974, as amended, post a notice that describes the regulations/procedures, including the name of the individual to whom reports may be made, and states where they may be examined.

(c) Procedures. The holder of a CP, COL, or ML subject to this section must adopt appropriate procedures to—

(1) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (c)(2) of this section, in all cases within 60 days of discovery, to identify a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected.

(2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from the discovery of the deviation or failure to comply, an interim report is prepared and submitted to the Commission through a director or responsible officer, or designated person as discussed in paragraph (d)(5) of this section. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply.

(3) Ensure that a director or responsible officer of the holder of a CP, COL, or ML subject to this section is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in paragraph (c)(1) or (c)(2) of this section, if the construction or manufacture of a facility or activity, or a basic component supplied for such a facility or activity—

(i) Fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable regulation, order, or license of the Commission relating to a substantial safety hazard;

(ii) Contains a defect; or

(iii) Underwent any significant breakdown in any portion of the quality assurance program (QAP) conducted under the requirements of appendix B to part 50 of this chapter that could have produced a defect in a basic component. These breakdowns in the QAP are reportable whether or not the breakdown actually resulted in a defect in a design approved and released for construction, installation, or manufacture.

(d) Reporting defects and noncompliance. (1) The holder of a CP, COL, or ML subject to this section that obtains information reasonably indicating that the facility or manufactured reactors fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable regulation, order, or license of the Commission relating to a substantial safety hazard must notify the Commission of the failure to comply through a director, responsible officer, or designated person as discussed in paragraph (d)(5) of this section.

(2) The holder of a CP, COL, or ML subject to this section that obtains information reasonably indicating the existence of any defect found in the construction or manufacture, or any defect found in the final design of a facility as approved and released for construction or manufacture, must notify the Commission of the defect through a director, responsible officer, or designated person as discussed in paragraph (d)(5) of this section.

(3) The holder of a CP, COL, or ML subject to this part, who obtains information reasonably indicating that the QAP has undergone any significant breakdown discussed in paragraph (c)(3)(iii) of this section must notify the Commission of the breakdown in the QAP through a director, responsible officer, or designated person as discussed in paragraph (d)(5) of this section.

(4) When acting as a dedicating entity, the holder of a CP, COL, or ML subject to this section is responsible for identifying and evaluating deviations; reporting defects and failures to comply associated with substantial safety hazards for dedicated items; and maintaining auditable records for the dedication process.

(5) The notification requirements of this paragraph (d) apply to all defects and failures to comply associated with a substantial safety hazard regardless of whether extensive evaluation, redesign, or repair is required to conform to the criteria and bases stated in the Safety Analysis Report, CP, COL, or ML. Evaluation of potential defects and failures to comply and reporting of defects and failures to comply under this section satisfies the CP holder's, COL holder's, and ML holder's evaluation and notification obligations under 10 CFR part 21, and satisfies the responsibility of individual directors or responsible officers or holders of a CP, COL, or ML subject to this section to report defects, and failures to comply associated with substantial safety hazards under section 206 of the Energy Reorganization Act of 1974, as amended. The director or responsible officer may authorize an individual to provide the notification required by this section. However, this does not relieve the director or responsible officer of his or her responsibility under this section.

(e) Notification—timing and where sent. The notification required by paragraph (d) of this section must consist of—

(1) Initial notification by telephone, facsimile, or email identified in appendix A to 10 CFR part 73 to the U.S. Nuclear Regulatory Commission (NRC) Operations Center within 2 days following receipt of information by the director or responsible corporate officer under paragraph (c)(3) of this section, on the identification of a defect or a failure to comply. If the CP, COL, or ML holder elects to use facsimile, verification that the facsimile has been received should be made by calling the NRC Operations Center. This paragraph (e)(1) does not apply to interim reports described in paragraph (c)(2) of this section.

(2) Written notification submitted to the NRC Document Control Desk by an appropriate method listed in § 53.040, with a copy to the appropriate NRC Regional Administrator at the address specified in appendix D to 10 CFR part 20 and a copy to the appropriate NRC resident inspector, if applicable, within 30 days following receipt of information by the director or responsible corporate officer under paragraph (c)(3) of this section, on the identification of a defect or failure to comply.

(f) Content of notification. The written notification required by paragraph (e)(2) of this section must clearly indicate that the written notification is being submitted under this section and include the following information, to the extent known.

(1) Name and address of the individual or individuals informing the Commission.

(2) Identification of the facility, the activity, or the basic component supplied for the facility or the activity within the United States which contains a defect or fails to comply.

(3) Identification of the firm constructing or manufacturing the facility or supplying the basic component which fails to comply or contains a defect.

(4) Nature of the defect or failure to comply and the safety hazard which is created or could be created by the defect or failure to comply.

(5) The date on which the information of a defect or failure to comply was obtained.

(6) In the case of a basic component that contains a defect or failure to comply, the number and location of these components in use at the facility subject to the regulations in this part.

(7) In the case of a completed reactor manufactured under this part, the entities to which the reactor was supplied.

(8) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

(9) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to other entities.

(g) Procurement documents. Each holder of a CP, COL, or ML subject to this section must ensure that each procurement document for a facility or a basic component specifies the provisions of 10 CFR part 21 or this section that apply, as applicable.

(h) Coordination with 10 CFR part 21. The requirements of this section are satisfied when the defect or failure to comply associated with a substantial safety hazard has been previously reported under 10 CFR part 21, under § 73.1205 of this chapter, under this section, or under § 53.1640.

(i) Records retention. The holder of a CP, COL, or ML subject to this section must prepare and maintain records necessary to accomplish the purposes of this section, specifically—

(1) Retain procurement documents, which define the requirements that facilities or basic components must satisfy in order to be considered acceptable, for the lifetime of the facility or basic component.

(2) Retain records of evaluations of all deviations and failures to comply under paragraph (c)(1) of this section for the longest of—

(i) Ten years from the date of the evaluation;

(ii) Five years from the date that an early site permit is referenced in an application for a COL; or

(iii) Five years from the date of delivery of a manufactured reactor.

(3) Retain records of all interim reports to the Commission made under paragraph (c)(2) of this section, or notifications to the Commission made under paragraph (d) of this section for the minimum time periods stated in paragraph (i)(2) of this section;

(4) Suppliers of basic components must retain records of—

(i) All notifications sent to affected licensees or purchasers under paragraph (d)(4) of this section for a minimum of 10 years following the date of the notification;

(ii) The facilities or other purchasers to whom the basic components or associated services were supplied for a minimum of 15 years from the delivery of the basic component or associated services.

(5) Maintaining reports in accordance with this section satisfies the recordkeeping obligations under 10 CFR part 21 of the entities, including directors or responsible officers thereof, subject to this section.

(a) Management and control. Licensees must ensure that the following plans, programs, and organizational units are developed and implemented to manage and control the construction activities:

(1) Programs to ensure that the construction of a commercial nuclear plant supports the eventual compliance with the design and analysis requirements in subpart C of this part.

(2) An organization, headed by qualified personnel, responsible for managing, controlling, and evaluating the adequacy of the construction activities.

(3) Procedures describing the qualifications for personnel in key positions in the licensee's management and control organization and the organizational responsibilities, authority, and interfaces with other parts of the licensee's organization.

(4) Procedures to evaluate the applicability of other national and international construction experience to the planned and ongoing construction activities and to ensure the applicable experience will be provided to those constructing the plant.

(5) A fitness-for-duty program, under 10 CFR part 26.

(6)(i) A QAP meeting the requirements of appendix B of part 50 of this chapter as required by § 53.460(b).

(ii) Appropriate programmatic controls to provide special treatment for non-safety-related but safety-significant structures, systems, and components (SSCs).

(7) A radiation protection program, in accordance with 10 CFR part 20, that includes measures for monitoring the dose to individuals working with radioactive materials brought onto the site, as applicable.

(8) An information security program in accordance with §§ 73.21, 73.22, and 73.23 of this chapter, as applicable.

(b) Construction activities. No person may begin the construction of a commercial nuclear plant on a site on which the facility is to be operated under this part until that person has been issued either a CP or COL, an early site permit authorizing activities under § 53.1130, or an LWA under this part.

(1) Licensees must satisfy the following requirements:

(i) As appropriate, considering the types and quantities of radioactive materials being brought onto the site—

(A) The licensee must maintain and follow a special nuclear material (SNM) material control and accounting program, a measurement control program, and other material control procedures that include corresponding record management requirements as required by the provisions of § 70.32 of this chapter. Prior to initial receipt of SNM onsite, the licensee must implement an SNM material control and accounting program in accordance with 10 CFR part 74.

(B) Procedures must be in place to receive, possess, use, and store source, byproduct, and SNM in accordance with applicable portions of 10 CFR parts 30, 40, and 70.

(C) A plant staff training program associated with the receipt of radioactive material must be approved and implemented prior to initial receipt of byproduct, source or SNM (excluding exempt quantities as described in § 30.18 of this chapter).

(ii) For construction of a commercial nuclear plant involving multiple reactor units, plans and procedures must be in place to prevent or mitigate potential hazards to the SSCs of operating units resulting from construction activities, including the managerial and administrative controls to be used to provide assurance that the limiting conditions for operation of the operating units are not exceeded as a result of construction activities.

(iii) Procedures must be in place prior to the start of construction activities that describe how construction will be controlled so as not to impact other features important to the design, such as dewatering, slope stability, backfill, compaction, and seepage.

(iv) For LWA holders, a plan must be developed for redress of activities performed under the LWA should one of the following situations arise:

(A) LWA work activities are terminated by the holder of the LWA;

(B) The LWA is revoked by the NRC; or

(C) The Commission denies the associated CP or COL application.

(2)(i) Onsite fresh fuel must be protected and stored in compliance with § 73.67 of this chapter.

(ii) Before initial fuel load into the reactor (or, for a fueled manufactured reactor, before initiating the removal of the features to prevent criticality required under § 53.620(d)(1)), a cybersecurity program that meets the requirements of § 73.54 or § 73.110 of this chapter, a physical security program that meets the requirements of § 73.55 or § 73.100 of this chapter, and an access authorization program that meets the requirements of § 73.56 or § 73.120 of this chapter must be established, as applicable.

(iii) Fire protection measures must be implemented for work and storage areas (including adjacent fire areas that could affect the work or storage area) before initial receipt of byproduct, source, or non-fuel SNM (excluding exempt quantities as described in § 30.18 of this chapter). The fire protection measures for areas associated with new fuel (including all fuel handling, fuel storage, and adjacent fire areas that could affect the new fuel) must be implemented before receipt of fuel. Prior to the receipt of fuel, a formal letter of agreement must be in place with the local fire department specifying the nature of arrangements in support of the fire protection program.

(c) Inspection and acceptance. (1) The licensee must have a process for accepting individual or groups of SSCs upon completion of construction and protecting them from damage or tampering as other construction activities continue.

(2) The post-construction acceptance process must address the inspections, tests, analyses, and acceptance criteria specified in the COL under § 53.1440 or the equivalent verifications needed to support the issuance of an operating license under § 53.1387.

(a) Management and control. Holders of MLs must ensure that the following plans, programs, and organizational units are developed and implemented to manage and control the manufacturing activities within the scope of the ML:

(1) Programs to ensure that the manufacturing of a manufactured reactor or portions of a manufactured reactor complies with the design and analysis requirements in subpart C of this part. The entity with design authority for the manufactured reactor covered by the ML must be identified in the license.

(2) An organizational and management structure responsible for managing, controlling, and evaluating the adequacy of the reactor design and manufacturing activities.

(3) Procedures describing the qualifications for personnel in key positions in the licensee's management and control organization and the organizational responsibilities, authority, and interfaces with other parts of the licensee's organization.

(4) A program to evaluate the applicability of other national and international design and manufacturing experience to the planned and ongoing manufacturing activities.

(5) A fitness-for-duty program, in accordance with 10 CFR part 26.

(6)(i) A QAP meeting the requirements of appendix B to part 50 of this chapter, to be applied to the design, fabrication, construction, and testing of the SSCs of the manufactured reactor.

(ii) Appropriate programmatic controls to provide special treatment measures for non-safety-related but safety-significant SSCs.

(7) A radiation protection program, in accordance with 10 CFR part 20, that includes measures for monitoring the dose to individuals if the manufacturing activities include working with radioactive materials.

(8) An information security program in accordance with §§ 73.21, 73.22 and 73.23 of this chapter, as applicable.

(b) Manufacturing activities. Holders of MLs must satisfy the following requirements:

(1) The manufacturing process must be conducted within facilities for which the ML holder has the authority to establish controls on any activity that might affect manufacturing. The licensee must establish access controls to the portions of each facility involved in the manufacturing processes governed by the ML.

(2) Manufacturing processes must be performed in accordance with the ML and the referenced codes and standards that have been endorsed or otherwise found acceptable by the NRC.

(3) A post-manufacturing inspection and acceptance process must be established and implemented before transporting a manufactured reactor or portions of a manufactured reactor for installation at a commercial nuclear plant. The process must consider the results of inspections, tests, and analyses that have been performed and the acceptance criteria that are necessary and sufficient to conclude that manufacturing activities have been completed in accordance with the ML.

(c) Control of radioactive materials. As appropriate considering the types and quantities of radioactive materials being brought into the manufacturing facility—

(1) Procedures must be in place to receive, transfer, possess, and use source, byproduct, and SNM in accordance with the applicable portions of 10 CFR parts 30, 40 and 70.

(2) A fire protection program must be established and implemented before the initial receipt of byproduct, source, or non-fuel SNM (excluding exempt quantities as described in § 30.18 of this chapter).

(3) An emergency plan appropriate for responding to the facility-specific hazards of an accidental release of radioactive material and to limit the health effects of the associated chemical hazards of licensed material must be approved and implemented prior to the receipt of byproduct, source, or SNM (excluding exempt quantities as described in § 30.18 of this chapter).

(4) A plant staff training program associated with the receipt of radioactive material must be approved and implemented before initial receipt of byproduct, source, or SNM (excluding exempt quantities as described in § 30.18 of this chapter).

(5) Security requirements must be implemented for the protection of SNM based on the type, enrichment, and quantity in accordance with 10 CFR part 73, as applicable, and for the protection of Category 1 and Category 2 quantities of radioactive material in accordance with 10 CFR part 37, as applicable.

(d) Fuel loading. (1)(i) An ML may authorize possession of a manufactured reactor into which the licensee has loaded fresh (unirradiated) fuel pursuant to a license issued under part 70 of this chapter only if the manufactured reactor is configured during its loading, storage, and transport with features to prevent criticality that are specified in the ML.

(ii) The ML applicant may file a separate, subsequent application for the 10 CFR part 70 license or combine the application for the 10 CFR part 70 license with the application for an ML.

(iii) The Commission has determined that any such fueled manufactured reactor in which the features to prevent criticality are in place is not in operation.

(iv) Upon installation of the fueled manufactured reactor in its place of operation and a Commission finding that the acceptance criteria in the COL that authorized reactor construction are met under § 53.1452(g), or that any conditions in the CP that authorized reactor construction are met and the associated operating license (OL) issued, the features to prevent criticality may be removed. Upon initiating the removal of the features to prevent criticality, the fueled manufactured reactor has commenced operation.

(2) Holders of part 70 licenses authorizing the possession and loading of fresh fuel into manufactured reactors must comply with the requirements of part 70 for the facilities and activities related to the storage, movement, and loading of fresh fuel in the manufactured reactor. Holders of these part 70 licenses must comply with the requirements of Subpart H to part 70, regardless of whether their proposed activities meet the applicability criteria found in 10 CFR 70.60. Procedures, equipment, and personnel required by the 10 CFR part 70 license, must be in place before the receipt of SNM at the manufacturing facility.

(i) Before the receipt of SNM, the licensee must have security programs in place that meet the performance objectives of 10 CFR 73.67, with the following additions and exceptions:

(A) A physical security plan describing the physical security program must be maintained and a cybersecurity program must be established for the possession and loading of fresh fuel into a manufactured reactor authorized by a 10 CFR part 70 license, regardless of fuel type, enrichment, and quantity.

(B) The physical security program must be designed to prevent unintended and uncontrolled criticality events.

(C) The cybersecurity program must provide reasonable assurance that a cyberattack does not adversely impact the functions performed by digital assets necessary for implementing the physical security requirements of this section, or the radiation monitoring and criticality requirements in this section or in 10 CFR part 70.

(D) All holders of a part 70 license that authorizes loading of fresh fuel into a manufactured reactor must perform the screening required in § 73.67(d)(4) of this chapter to confirm the identity, trustworthiness, and reliability of individuals prior to granting unescorted access to special nuclear material; these determinations must be documented.

(ii) [Reserved]

(3) The loading or unloading of fresh fuel into or from a manufactured reactor and any changes to the configuration of reactivity control and prevention systems for the fueled manufactured reactor must be performed by a certified fuel handler meeting the requirements in subpart F of this part.

(e) Transportation. (1) A holder of an ML may not transport or allow to be removed from the places of manufacture the manufactured reactor or portions thereof as defined in the ML except for either transport to a site for which the Commission has issued a COL or CP that references the subject ML or export in accordance with 10 CFR part 110.

(2) A holder of an ML must include in any contract governing the transport of a manufactured reactor or portions thereof as defined in the ML from the places of manufacture to any other location, a provision requiring that the person transporting the manufactured reactor comply with all shipping requirements in applicable NRC regulations, certificates of compliance, and NRC-issued licenses.

(3) Procedures governing the preparation of the manufactured reactor or portions thereof as defined in the ML for transport and the conduct of the transport must be issued prior to transport. The procedures must implement the protective measures and restrictions described in NRC regulations and NRC-issued licenses to protect the reactor from potential conditions that would adversely affect the safe operation of a commercial nuclear plant.

(4) For a manufactured reactor that is to be loaded with fresh fuel before transport to the place of operation, the ML must specify that transportation will be in accordance with parts 71 and 73 of this chapter.

(f) Acceptance and installation at the site for which the Commission has issued a COL or CP that references the subject ML. (1) Installation at the site for which the Commission has issued a COL or CP that references the subject ML must follow the regulations in § 53.610.

(2) Upon arrival at the site, the manufactured reactor or portions of a manufactured reactor may not be installed in its place of operation unless the COL or CP holder performs inspections sufficient to verify the reactor is in compliance with the ML and has not been damaged in transit. The COL or CP holder must perform these inspections in accordance with documented procedures subject to quality assurance measures commensurate with their importance to safety. In addition, inspections must confirm that the interface requirements between the manufactured reactor or portions of a manufactured reactor and the remaining portions of the commercial nuclear plant are met.