§ 53.605 — Reporting of defects and noncompliance.

§ 53.605 Reporting of defects and noncompliance.

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.