1、1/13NRC Regulations (10 CFR) PART 21-REPORTING OF DEFECTS AND NONCOMPLIANCE PART 21-REPORTING OF DEFECTS AND NONCOMPLIANCEPart IndexGeneral ProvisionsSec.21.1 Purpose.21.2 Scope.21.3 Definitions.21.4 Interpretations.21.5 Communications.21.6 Posting requirements.21.7 Exemptions.21.8 Information colle
2、ction requirements: OMB approval.Notification21.21 Notification of failure to comply or existence of a defect and its evaluation.Procurement Documents21.31 Procurement documents.Inspections, Records21.41 Inspections.21.51 Maintenance and inspection of records.Enforcement21.61 Failure to notify.21.62
3、 Criminal penalties.Authority: Sec. 161, 68 Stat. 948, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2953 (42 U.S.C. 2201, 2282, 2297f); secs. 201, as amended, 206, 88 Stat. 1242, as amended, 1246 (42 U.S.C. 5841, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).Se
4、ction 21.2 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).Source: 42 FR 28893, June 6, 1977, unless otherwise noted.General Provisions 21.1 Purpose.The regulations in this part establish procedures and requirements for implementation of section 206 of
5、the Energy Reorganization Act of 1974. That section requires any individual director or responsible officer of a firm constructing, owning, operating or supplying the components of any facility or activity which is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended
6、, or the Energy Reorganization Act of 1974, who obtains information reasonably indicating: (a) That the facility, activity or basic component supplied to such facility or activity fails to 2/13comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or licens
7、e of the Commission relating to substantial safety hazards or (b) that the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard, to immediately notify the Commission of such failure to comply or such defect, unl
8、ess he has actual knowledge that the Commission has been adequately informed of such defect or failure to comply. 21.2 Scope.(a) The regulations in this part apply, except as specifically provided otherwise in parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or part 72 of this chapter, to:(1) Each individu
9、al, partnership, corporation, or other entity applying for or holding a license or permit under theregulations in this chapter to possess, use, or transfer within the United States source material, byproduct material,special nuclear material, and/or spent fuel and high-level radioactive waste, or to
10、 construct, manufacture, possess, own, operate, or transfer within the United States, any production or utilization facility or independent spent fuelstorage installation (ISFSI) or monitored retrievable storage installation (MRS); and each director and responsibleofficer of such a licensee;(2) Each
11、 individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, that constructs a production or utilization facility licensed for manufacture, construction, or operation under parts 50 or 52 of this ch
12、apter, an ISFSI for the storage of spent fuel licensed under part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste under part 72 of this chapter, or a geologic repository for the disposal of high-level radioactive waste under part 60 or 63 of this chapter; or
13、supplies basic components for a facility or activity licensed, other than for export, under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or part 72 of this chapter;(3) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible o
14、fficer of such an organization, applying for a design certification rule under part 52 of this chapter; or supplying basic components with respect to that design certification, and each individual, corporation, partnership, or other entity doing business within the United States, and each director a
15、nd responsible officer of such an organization, whose application for design certification has been granted under part 52 of this chapter, or who has supplied or issupplying basic components with respect to that design certification;(4) Each individual, corporation, partnership, or other entity doin
16、g business within the United States, and each director and responsible officer of such an organization, applying for or holding a standard 3/13design approval under part 52 of this chapter; or supplying basic components with respect to a standard design approval under part 52 of this chapter;(b) For
17、 persons licensed to construct a facility under either a construction permit issued under 50.23 of this chapter or a combined license under part 52 of this chapter (for the period of construction until the date that the Commission makes the finding under 52.103(g) of this chapter), or to manufacture
18、 a facility under part 52 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under 50.55(e) of this chapter satisfies each persons evaluation, notification, and reporting obligation to report defects and failures to comply under th
19、is part and the responsibility of individual directors and responsible officers of these licensees to reportdefects under Section 206 of the Energy Reorganization Act of 1974.(c) For persons licensed to operate a nuclear power plant under part 50 or part 52 of this chapter, evaluation ofpotential de
20、fects and appropriate reporting of defects under 50.72, 50.73, or 73.71 of this chapter, satisfies each persons evaluation, notification, and reporting obligation to report defects under this part, and the responsibility of individual directors and responsible officers of these licensees to report d
21、efects under Section 206 of the Energy Reorganization Act of 1974.(d) Nothing in these regulations should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item (as defined in 21.3) not subject to the regulations in this part from reporting to the Commis
22、sion, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. NRC regional offices and headquarters will accept collect telephone calls from individuals who wish to speak to NRC representatives concerning nucle
23、ar safety-related problems. The location and telephone numbers of the four regions (answered during regular working hours), are listed in appendix D to part 20 of this chapter. The telephone number of the NRC Operations Center (answered 24 hours a day-including holidays) is (301) 816-5100.(e) The re
24、gulations in this part apply in accordance with 10 CFR 76.60 to each individual, partnership, corporation, or other entity required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter.56 FR 36089, July 31, 1991, as amended at 59 FR 14086, Mar. 25, 1994;
25、 59 FR 48959, Sept. 23, 1994; 60 FR 48373, Sept. 19, 1995; 66 FR 55790, Nov. 2, 2001; 72 FR 49486, Aug. 28, 2007 21.3 Definitions.As used in this part:Basic component. (1)(i) When applied to nuclear power plants licensed under 10 CFR part 50 or part 52 of this chapter, basic component means a struct
26、ure, system, or component, or part thereof that affects its safety function necessary to assure:4/13(A) The integrity of the reactor coolant pressure boundary;(B) The capability to shut down the reactor and maintain it in a safe shutdown condition; or(C) The capability to prevent or mitigate the con
27、sequences of accidents which could result in potential offsite exposures comparable to those referred to in 50.34(a)(1), 50.67(b)(2), or 100.11 of this chapter, as applicable.(ii) Basic components are items designed and manufactured under a quality assurance program complying with appendix B to part
28、 50 of this chapter, or commercial grade items which have successfully completed the dedication process.(2) When applied to standard design certifications under subpart C of part 52 of this chapter and standard designapprovals under part 52 of this chapter, basic component means the design or procur
29、ement information approved or to be approved within the scope of the design certification or approval for a structure, system, or component, or partthereof, that affects its safety function necessary to assure:(i) The integrity of the reactor coolant pressure boundary;(ii) The capability to shut dow
30、n the reactor and maintain it in a safeshutdown condition; or(iii) The capability to prevent or mitigate the consequences of accidents which could result in potential offsiteexposures comparable to those referred to in 50.34(a)(1), 50.67(b)(2), or 100.11 of this chapter, as applicable.(3) When appli
31、ed to other facilities and other activities licensed under 10 CFR parts 30, 40, 50 (other than nuclearpower plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic component means a structure, system, or component, orpart thereof, that affects their safety function, that is directly procured by th
32、e licensee of a facility or activity subjectto the regulations in this part and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the Commission could create a substantial safety hazard.(4) In all cases, basic component includes safety
33、-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware, design certification, design approval, or information in support of an early site permit application under part 52 of this chapter, whether these
34、 services are performed by the component supplier or others.Commercial grade item. (1) When applied to nuclear power plants licensed pursuant to 10 CFR Part 30, 40, 50, 60, commercial grade item means a structure, system, or component, or part thereof that 5/13affects its safety function, that was n
35、ot designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteris
36、tics of the item cannot be verified).(2) When applied to facilities and activities licensed pursuant to 10 CFR Parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, commercial grade item means an item that is:(i) Not subject to design or specification requirements that are u
37、nique to those facilities or activities;(ii) Used in applications other than those facilities or activities; and(iii) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturers published product description (for example, a catalog).Commission means the
38、 Nuclear Regulatory Commission or its duly authorized representatives.Constructing or construction means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to the regulations in this part
39、and consulting services related to the facility or activity that are safety related.Critical characteristics. When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, critical characteristics are those important design, material, and performance characteristics of a commercial grade
40、 item that, once verified, will provide reasonable assurance that the item will perform its intended safety function.Dedicating entity. When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, dedicating entity means the organization that performs the dedication process. Dedication
41、may be performed by the manufacturer of the item, a third-party dedicating entity, or the licensee itself. The dedicating entity, pursuant to 21.21(c) of this part, is responsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintain
42、ing auditable records of the dedication process.Dedication. (1) When applied to nuclear power plants licensed pursuant to 10 CFR Part 30, 40, 50, 60, dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perfo
43、rm its intended safety function and, in this respect, is deemed equivalent to an item designed and manufactured under a 10 CFR Part 50, appendix B, quality assurance program. This assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspe
44、ctions, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys; product inspections or witness at holdpoints at the manufacturers facility, and analysis of historical records f
45、or acceptable performance. In all cases, the dedication process must be conducted in accordance with the applicable provisions of 10 CFR Part 50, appendix B. The process is considered complete when the item is designated for use as a basic component.6/13(2) When applied to facilities and activities
46、licensed pursuant to 10 CFR Parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, dedication occurs after receipt when that item is designated for use as a basic component.Defect means:(1) A deviation in a basic component delivered to a purchaser for use in a facility or an
47、activity subject to theregulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard;(2) The installation, use, or operation of a basic component containing a defect as defined in this section;(3) A deviation in a portion of a facility subject to
48、the early site permit, standard design certification, standard design approval, construction permit, combined license or manufacturing licensing requirements of part 50 or part 52 of this chapter, provided the deviation could, on the basis of an evaluation, create a substantial safety hazard and the
49、 portion of the facility containing the deviation has been offered to the purchaser for acceptance;(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued under part 50 or part 52 of this chapter; or(5) An error, omission or other circumstance in a design certification, or standard design approval that, on the basis of an evaluation, could create a substantial safety hazard.Deviation means a departure from the technical
