§ 50.55 Conditions of construction permits, early site permits, combined licenses, and manufacturing licenses. Each construction permit for a utilization facility is subject to the following terms and conditions and the applicable requirements of § 50.55a; each construction permit for a production facility is subject to the following terms and conditions with the exception of paragraph (i); each early site permit is subject to the terms and conditions in paragraph (f) of this section; each manufacturing license is subject to the terms and conditions in paragraphs (e), (f), and (i) of this section and the applicable requirements of § 50.55a; and each combined license is subject to the terms and conditions in paragraphs (e), (f), and (i) of this section and the applicable requirements of § 50.55a until the date that the Commission makes the finding under § 52.103(g) of this chapter: ( a ) The construction permit shall state the earliest and latest dates for completion of the construction or modification.
( b ) If the proposed construction or modification of the facility is not completed by the latest completion date, the construction permit shall expire and all rights are forfeited. However, upon good cause shown, the Commission will extend the completion date for a reasonable period of time. The Commission will recognize, among other things, developmental problems attributable to the experimental nature of the facility or fire, flood, explosion, strike, sabotage, domestic violence, enemy action, an act of the elements, and other acts beyond the control of the permit holder, as a basis for extending the completion date.
( c ) Except as modified by this section and § 50.55a, the construction permit shall be subject to the same conditions to which a license is subject.
( d ) At or about the time of completion of the construction or modification of the facility, the applicant will file any additional information needed to bring the original application for license up to date, and will file an application for an operating license or an amendment to an application for a license to construct and operate the facility for the issuance of an operating license, as appropriate, as specified in § 50.30(d) of this part.
( e ) ( 1 ) *Definitions.* For purposes of this paragraph, the definitions in § 21.3 of this chapter apply.
( 2 ) *Posting requirements.* ( i ) Each individual, partnership, corporation, dedicating entity, or other entity subject to the regulations in this part (*i.e.,* holders of a construction permit, combined license, or a manufacturing license) must post current copies of the regulations in this part, Section 206 of the Energy Reorganization Act of 1974 (ERA), and procedures adopted under the regulations in this part. These documents must be posted in a conspicuous position on any premises within the United States where the activities subject to this part are conducted.
( ii ) If posting of the regulations in this part or the procedures adopted under the regulations in this part is not practicable, the licensee or firm subject to the regulations in this part may, in addition to posting Section 206 of the ERA, post a notice which describes the regulations/procedures, including the name of the individual to whom reports may be made, and states where the regulation, procedures, and reports may be examined.
( 3 ) *Procedures.* Each individual, corporation, partnership, or other entity holding a facility construction permit subject to this part, combined license (until the Commission makes the finding under 10 CFR 52.103(g)), and manufacturing license under 10 CFR part 52 must adopt appropriate procedures to— ( i ) 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 (e)(3)(ii) 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.
( ii ) 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 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 (e)(4)(v) 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.
( iii ) Ensure that a director or responsible officer of the holder of a facility construction permit subject to this part, combined license (until the Commission makes the finding under 10 CFR 52.103(g)), and manufacturing license under 10 CFR part 52 is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in paragraph (e)(3)(i) or (e)(3)(ii) of this section, if the construction or manufacture of a facility or activity or manufactured reactor, or a basic component supplied for such facility or activity— ( A ) Fails to comply with the AEA, as amended, or any applicable regulation, order, or license of the Commission, relating to a substantial safety hazard;
( B ) Contains a defect; or
( C ) Undergoes any significant breakdown in any portion of the quality assurance program conducted under the requirements of appendix B to 10 CFR part 50 which could have produced a defect in a basic component. These breakdowns in the quality assurance program are reportable whether or not the breakdown actually resulted in a defect in a design approved and released for construction, installation, or manufacture.
( 4 ) *Notification.* ( i ) The holder of a facility construction permit subject to this part, combined license (until the Commission makes the finding under 10 CFR 52.103(g)), and manufacturing license who obtains information reasonably indicating that the facility fails to comply with the AEA, 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 or responsible officer or designated person as discussed in paragraph (e)(4)(v) of this section.
( ii ) The holder of a facility construction permit subject to this part, combined license, or manufacturing license, who 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 or manufactured reactor as approved and released for construction or manufacture, must notify the Commission of the defect through a director or responsible officer or designated person as discussed in paragraph (e)(4)(v) of this section.
( iii ) The holder of a facility construction permit subject to this part, combined license, or manufacturing license, who obtains information reasonably indicating that the quality assurance program has undergone any significant breakdown discussed in paragraph (e)(3)(iii)(C) of this section must notify the Commission of the breakdown in the quality assurance program through a director or responsible officer or designated person as discussed in paragraph (e)(4)(v) of this section.
( iv ) A dedicating entity is responsible for identifying and evaluating deviations and reporting defects and failures to comply associated with substantial safety hazards for dedicated items; and maintaining auditable records for the dedication process.
( v ) The notification requirements of this paragraph 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, construction permit, combined license, or manufacturing license. Evaluation of potential defects and failures to comply and reporting of defects and failures to comply under this section satisfies the construction permit holder's, combined license holder's, and manufacturing license holder's evaluation and notification obligations under part 21 of this chapter, and satisfies the responsibility of individual directors or responsible officers of holders of construction permits issued under § 50.23, holders of combined licenses (until the Commission makes the finding under § 52.103 of this chapter), and holders of manufacturing licenses to report defects, and failures to comply associated with substantial safety hazards under Section 206 of the ERA. The director or responsible officer may authorize an individual to provide the notification required by this section, provided that this must not relieve the director or responsible officer of his or her responsibility under this section.
( 5 ) *Notification—timing and where sent.* The notification required by paragraph (e)(4) of this section must consist of— ( i ) Initial notification by email, which is the preferred method of notification, or facsimile to the NRC Operations Center at (301) 816-5151 or by telephone at (301) 816-5100 within 2 days following receipt of information by the director or responsible corporate officer under paragraph (e)(3)(iii) of this section, on the identification of a defect or a failure to comply. Verification that the email or facsimile has been received should be made by calling the NRC Operations Center. This paragraph does not apply to interim reports described in paragraph (e)(3)(ii) of this section.
( ii ) Written notification submitted to the Document Control Desk, U.S. Nuclear Regulatory Commission, by an appropriate method listed in § 50.4, with a copy to the appropriate Regional Administrator at the address specified in appendix D to part 20 of this chapter and a copy to the appropriate NRC resident inspector within 30 days following receipt of information by the director or responsible corporate officer under paragraph (e)(3)(iii) of this section, on the identification of a defect or failure to comply.
( 6 ) *Content of notification.* The written notification required by paragraph (e)(5)(ii) of this section must clearly indicate that the written notification is being submitted under § 50.55(e) and include the following information, to the extent known. ( i ) Name and address of the individual or individuals informing the Commission.
( ii ) 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.
( iii ) Identification of the firm constructing or manufacturing the facility or supplying the basic component which fails to comply or contains a defect.
( iv ) 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.
( v ) The date on which the information of a defect or failure to comply was obtained.
( vi ) In the case of a basic component which contains a defect or fails to comply, the number and location of all the basic components in use at the facility subject to the regulations in this part.
( vii ) In the case of a completed reactor manufactured under part 52 of this chapter, the entities to which the reactor was supplied.
( viii ) 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.
( ix ) 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.
( 7 ) *Procurement documents.* Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall ensure that each procurement document for a facility, or a basic component specifies or is issued by the entity subject to the regulations, when applicable, that the provisions of 10 CFR part 21 or 10 CFR 50.55(e) applies, as applicable.
( 8 ) *Coordination with 10 CFR part 21 .* The requirements of § 50.55(e) are satisfied when the defect or failure to comply associated with a substantial safety hazard has been previously reported under part 21 of this chapter, under § 73.1205 of this chapter, or under §§ 50.55(e) or 50.73. For holders of construction permits issued before October 29, 1991, evaluation, reporting and recordkeeping requirements of § 50.55(e) may be met by complying with the comparable requirements of part 21 of this chapter.
( 9 ) *Records retention.* The holder of a construction permit, combined license, and manufacturing license must prepare and maintain records necessary to accomplish the purposes of this section, specifically— ( i ) Retain procurement documents, which define the requirements that facilities or basic components must meet in order to be considered acceptable, for the lifetime of the facility or basic component.
( ii ) Retain records of evaluations of all deviations and failures to comply under paragraph (e)(3)(i) of this section for the longest of: ( A ) Ten (10) years from the date of the evaluation;
( B ) Five (5) years from the date that an early site permit is referenced in an application for a combined license; or
( C ) Five (5) years from the date of delivery of a manufactured reactor.
( iii ) Retain records of all interim reports to the Commission made under paragraph (e)(3)(ii) of this section, or notifications to the Commission made under paragraph (e)(4) of this section for the minimum time periods stated in paragraph (e)(9)(ii) of this section;
( iv ) Suppliers of basic components must retain records of: ( A ) All notifications sent to affected licensees or purchasers under paragraph (e)(4)(iv) of this section for a minimum of ten (10) years following the date of the notification;
( B ) The facilities or other purchasers to whom basic components or associated services were supplied for a minimum of fifteen (15) years from the delivery of the basic component or associated services.
( v ) Maintaining records in accordance with this section satisfies the recordkeeping obligations under part 21 of this chapter of the entities, including directors or responsible officers thereof, subject to this section.
( f ) ( 1 ) Each nuclear power plant or fuel reprocessing plant construction permit holder subject to the quality assurance criteria in appendix B of this part shall implement, pursuant to § 50.34(a)(7) of this part, the quality assurance program described or referenced in the Safety Analysis Report, including changes to that report.
( 2 ) Each construction permit holder described in paragraph (f)(1) of this section shall, by June 10, 1983, submit to the appropriate NRC Regional Office shown in appendix D of part 20 of this chapter the current description of the quality assurance program it is implementing for inclusion in the Safety Analysis Report, unless there are no changes to the description previously accepted by NRC. This submittal must identify changes made to the quality assurance program description since the description was submitted to NRC. (Should a permit holder need additional time beyond June 10, 1983 to submit its current quality assurance program description to NRC, it shall notify the appropriate NRC Regional Office in writing, explain why additional time is needed, and provide a schedule for NRC approval showing when its current quality assurance program description will be submitted.)
( 3 ) After March 11, 1983, each construction permit holder described in paragraph (f)(1) of this section may make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report, provided the change does not reduce the commitments in the program description previously accepted by the NRC. Changes to the quality assurance program description that do not reduce the commitments must be submitted to NRC within 90 days. Changes to the quality assurance program description that do reduce the commitments must be submitted to NRC and receive NRC approval before implementation, as follows: ( i ) Changes to the Safety Analysis Report must be submitted for review as specified in § 50.4. Changes made to NRC-accepted quality assurance topical report descriptions must be submitted as specified in § 50.4.
( ii ) The submittal of a change to the Safety Analysis Report quality assurance program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of this part and the Safety Analysis Report quality assurance program description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).
( iii ) A copy of the forwarding letter identifying the changes must be maintained as a facility record for three years.
( iv ) Changes to the quality assurance program description included or referenced in the Safety Analysis Report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first.
( 4 ) Each holder of an early site permit or a manufacturing license under part 52 of this chapter shall implement the quality assurance program described or referenced in the safety analysis report, including changes to that report. Each holder of a combined license shall implement the quality assurance program for design and construction described or referenced in the safety analysis report, including changes to that report, provided, however, that the holder of a combined license is not subject to the terms and conditions in this paragraph after the Commission makes the finding under § 52.103(g) of this chapter. ( i ) Each holder described in paragraph (f)(4) of this section may make a change to a previously accepted quality assurance program description included or referenced in the safety analysis report, if the change does not reduce the commitments in the program description previously accepted by the NRC. Changes to the quality assurance program description that do not reduce the commitments must be submitted to NRC within 90 days. Changes to the quality assurance program description that reduce the commitments must be submitted to NRC and receive NRC approval before implementation, as follows: ( A ) Changes to the safety analysis report must be submitted for review as specified in § 50.4. Changes made to NRC-accepted quality assurance topical report descriptions must be submitted as specified in § 50.4.
( B ) The submittal of a change to the safety analysis report quality assurance program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of this part and the safety analysis report quality assurance program description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).
( C ) A copy of the forwarding letter identifying the changes must be maintained as a facility record for three (3) years.
( D ) Changes to the quality assurance program description included or referenced in the safety analysis report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first.
( ii ) [Reserved]
( g ) - ( h ) [Reserved]
( i ) Structures, systems, and components subject to the codes and standards in 10 CFR 50.55a must be designed, fabricated, erected, constructed, tested, and inspected to quality standards commensurate with the importance of the safety function to be performed.
[21 FR 355, Jan. 19, 1956, as amended at 32 FR 4055, Mar. 15, 1967; 35 FR 11461, July 17, 1970; 35 FR 19661, Dec. 29, 1970; 36 FR 11424, June 12, 1971; 37 FR 6460, Mar. 30, 1972; 38 FR 1272, Jan. 11, 1973; 41 FR 16446, Apr. 19, 1976; 42 FR 43385, Aug. 29, 1977; 48 FR 1029, Jan. 10, 1983; 51 FR 40309, Nov. 6, 1986; 56 FR 36091, July 31, 1991; 59 FR 14087, Mar. 25, 1994; 68 FR 58809, Oct. 10, 2003; 72 FR 49497, Aug. 28, 2007; 78 FR 34248, June 7, 2013; 79 FR 65798, Nov. 5, 2014; 88 FR 15880, Mar. 14, 2023; 89 FR 57719, July 16, 2024]