(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. (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. (2) An organizational and management structure responsible for managing, controlling, and evaluating the adequacy of the reactor design and manufacturing activities.
3. (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. (4) A program to evaluate the applicability of other national and international design and manufacturing experience to the planned and ongoing manufacturing activities.
5. (5) A fitness-for-duty program, in accordance with 10 CFR part 26.

6. (6)

   1. (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.
   2. (ii) Appropriate programmatic controls to provide special treatment measures for non-safety-related but safety-significant SSCs.
7. (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. (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. (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. (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. (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. (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. (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. (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. (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. (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. (1)

   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.
   2. (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.
   3. (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.
   4. (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. (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.

   1. (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:

      1. (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.
      2. (B) The physical security program must be designed to prevent unintended and uncontrolled criticality events.
      3. (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.
      4. (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.
   2. (ii) [Reserved]
3. (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. (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. (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. (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. (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. (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. (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.