[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR21]
[Page 440-448]
TITLE 10--ENERGY
CHAPTER I--NUCLEAR REGULATORY COMMISSION
PART 21_REPORTING OF DEFECTS AND NONCOMPLIANCE--Table of Contents
General Provisions
Sec.
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 collection requirements: OMB approval.
Notification
21.21 Notification of failure to comply or existence of a defect and its
evaluation.
Procurement Documents
21.31 Procurement documents.
Inspections, Records
21.41 Inspections.
21.51 Maintenance and inspection of records.
Enforcement
21.61 Failure to notify.
21.62 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).
Section 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
Sec. 21.1 Purpose.
The regulations in this part establish procedures and requirements
for implementation of section 206 of 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, 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 comply with the Atomic Energy Act
of 1954, as amended, or any applicable rule, regulation, order, or
license 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, unless he has actual knowledge that the
Commission has been adequately informed of such defect or failure to
comply.
Sec. 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 individual, partnership, corporation, or other entity
applying for or holding a license or permit under the regulations 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 construct,
manufacture, possess, own, operate, or transfer within the United
States, any production or utilization facility or independent
[[Page 441]]
spent fuel storage installation (ISFSI) or monitored retrievable storage
installation (MRS); and each director and responsible officer of such a
licensee;
(2) Each 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 chapter, 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 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
officer 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 and 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 is supplying basic components with
respect to that design certification;
(4) Each individual, corporation, partnership, or other entity doing
business within the United States, and each director and responsible
officer of such an organization, applying for or holding a standard
design 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 persons licensed to construct a facility under either a
construction permit issued under Sec. 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
Sec. 52.103(g) of this chapter), or to manufacture 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 Sec.
50.55(e) of this chapter satisfies each person's evaluation,
notification, and reporting obligation to report defects and failures to
comply under this part and the responsibility of individual directors
and responsible officers of these licensees to report defects 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 of potential defects and
appropriate reporting of defects under Sec. Sec. 50.72, 50.73, or Sec.
73.71 of this chapter, satisfies each person's 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 defects 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 Sec. 21.3) not subject to the regulations in this part
from reporting to the Commission, 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 nuclear 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 regulations 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
[[Page 442]]
compliance plan under part 76 of this chapter.
[56 FR 36089, July 31, 1991, as amended at 59 FR 14086, Mar. 25, 1994;
59 FR 48959, Sept. 23, 1994; 60 FR 48373, Sept. 19, 1995; 66 FR 55790,
Nov. 2, 2001; 72 FR 49486, Aug. 28, 2007]
Sec. 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 structure, system, or component, or part thereof that
affects its safety function necessary to assure:
(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 consequences of
accidents which could result in potential offsite exposures comparable
to those referred to in Sec. Sec. 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 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 design approvals under part 52
of this chapter, basic component means the design or procurement
information approved or to be approved within the scope of the design
certification or approval for a structure, system, or component, or part
thereof, that affects its safety function necessary to assure:
(i) The integrity of the reactor coolant pressure boundary;
(ii) The capability to shut down the reactor and maintain it in a
safe-shutdown condition; or
(iii) The capability to prevent or mitigate the consequences of
accidents which could result in potential offsite exposures comparable
to those referred to in Sec. Sec. 50.34(a)(1), 50.67(b)(2), or 100.11
of this chapter, as applicable.
(3) When applied to other facilities and other activities licensed
under 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61,
63, 70, 71, or 72 of this chapter, basic component means a structure,
system, or component, or part thereof, that affects their safety
function, that is directly procured by the licensee of a facility or
activity subject to 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-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 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 50, commercial grade item means a
structure, system, or component, or part thereof that affects its safety
function, that was not 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 characteristics 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
unique 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 manufacturer's published product
description (for example, a catalog).
Commission means the Nuclear Regulatory Commission or its duly
authorized representatives.
[[Page 443]]
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 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 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 may be performed by the
manufacturer of the item, a third-party dedicating entity, or the
licensee itself. The dedicating entity, pursuant to Sec. 21.21(c) of
this part, is responsible for identifying and evaluating deviations,
reporting defects and failures to comply for the dedicated item, and
maintaining auditable records of the dedication process.
Dedication. (1) When applied to nuclear power plants licensed
pursuant to 10 CFR part 50, dedication is an acceptance process
undertaken to provide reasonable assurance that a commercial grade item
to be used as a basic component will perform 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
inspections, 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 manufacturer's facility, and analysis of
historical records for 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.
(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, 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 activity subject to the regulations 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 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 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 requirements included
in a procurement document, or specified in early site permit
information, a standard design certification or standard design
approval.
Director means an individual, appointed or elected according to law,
who is authorized to manage and direct the affairs of a corporation,
partnership or other entity. In the case of an individual
proprietorship, director means the individual.
[[Page 444]]
Discovery means the completion of the documentation first
identifying the existence of a deviation or failure to comply
potentially associated with a substantial safety hazard within the
evaluation procedures discussed in Sec. 21.21(a).
Evaluation means the process of determining whether a particular
deviation could create a substantial hazard or determining whether a
failure to comply is associated with a substantial safety hazard.
Notification means the telephonic communication to the NRC
Operations Center or written transmittal of information to the NRC
Document Control Desk.
Operating or operation means the operation of a facility or the
conduct of a licensed activity which is subject to the regulations in
this part and consulting services related to operations that are safety
related.
Procurement document means a contract that defines the requirements
which facilities or basic components must meet in order to be considered
acceptable by the purchaser.
Responsible officer means the president, vice-president or other
individual in the organization of a corporation, partnership, or other
entity who is vested with executive authority over activities subject to
this part.
Substantial safety hazard means a loss of safety function to the
extent that there is a major reduction in the degree of protection
provided to public health and safety for any facility or activity
licensed or otherwise approved or regulated by the NRC, other than for
export, under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72 of this
chapter.
Supplying or supplies means contractually responsible for a basic
component used or to be used in a facility or activity which is subject
to the regulations in this part.
[42 FR 28893, June 6, 1977; 42 FR 36803, July 18, 1977, as amended at 43
FR 48622, Oct. 19, 1978; 46 FR 58283, Dec. 1, 1981; 47 FR 57480, Dec.
27, 1982; 56 FR 36089, July 31, 1991; 59 FR 5519, Feb. 7, 1994; 60 FR
48373, Sept. 19, 1995; 61 FR 65171, Dec. 11, 1996; 64 FR 72000, Dec. 23,
1999; 66 FR 55790, Nov. 2, 2001; 72 FR 49486, Aug. 28, 2007]
Sec. 21.4 Interpretations.
Except as specifically authorized by the Commission in writing, no
interpretation of the meaning of the regulations in this part by any
officer or employee of the Commission other than a written
interpretation by the General Counsel will be recognized to be binding
upon the Commission.
Sec. 21.5 Communications.
Except where otherwise specified in this part, written
communications and reports concerning the regulations in this part must
be addressed to the NRC's Document Control Desk, and sent by mail to the
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand
delivery to the NRC's offices at 11555 Rockville Pike, Rockville,
Maryland; or, where practicable, by electronic submission, for example,
Electronic Information Exchange, or CD-ROM. Electronic submissions must
be made in a manner that enables the NRC to receive, read, authenticate,
distribute, and archive the submission, and process and retrieve it a
single page at a time. Detailed guidance on making electronic
submissions can be obtained by visiting the NRC's Web site at http://
www.nrc.gov/site-help/eie.html, by calling (301) 415-6030, by e-mail to
EIE@nrc.gov, or by writing the Office of Information Services, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance
discusses, among other topics, the formats the NRC can accept, the use
of electronic signatures, and the treatment of nonpublic information. In
the case of a licensee or permit holder, a copy of the communication
must also be sent to the appropriate Regional Administrator at the
address specified in appendix D to part 20 of this chapter.
[72 FR 49487, Aug. 28, 2007]
Sec. 21.6 Posting requirements.
(a)(1) Each individual, partnership, corporation, dedicating entity,
or other entity subject to the regulations in this part shall post
current copies of--
(i) The regulations in this part;
(ii) Section 206 of the Energy Reorganization Act of 1974; and
[[Page 445]]
(iii) Procedures adopted pursuant to the regulations in this part.
(2) 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.
(b) If posting of the regulations in this part or the procedures
adopted pursuant to 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, post a notice which describes the
regulations/procedures, including the name of the individual to whom
reports may be made, and states where they may be examined.
(c) The effective date of this section has been deferred until
January 6, 1978.
[42 FR 28893, June 6, 1977, as amended at 60 FR 48374, Sept. 19, 1995]
Sec. 21.7 Exemptions.
The Commission may, upon application of any interested person or
upon its own initiative, grant such exemptions from the requirements of
the regulations in this part as it determines are authorized by law and
will not endanger life or property or the common defense and security
and are otherwise in the public interest. Suppliers of commercial grade
items are exempt from the provisions of this part to the extent that
they supply commercial grade items.
[42 FR 28893, June 6, 1977, as amended at 43 FR 48622, Oct. 19, 1978]
Sec. 21.8 Information collection requirements: OMB approval.
(a) The Nuclear Regulatory Commission has submitted the information
collection requirements contained in this part to the Office of
Management and Budget (OMB) for approval as required by the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. OMB
has approved the information collection requirements contained in this
part under control number 3150-0035.
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 21.7, 21.21 and 21.51.
[62 FR 52185, Oct. 6, 1997]
Notification
Sec. 21.21 Notification of failure to comply or existence of a defect
and its evaluation.
(a) Each individual, corporation, partnership, dedicating entity, or
other entity subject to the regulations in this part shall 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 (a)(2) of this
section, in all cases within 60 days of discovery, in order to identify
a reportable defect or failure to comply that could create a substantial
safety hazard, were it to remain uncorrected, and
(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 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 Sec. 21.21(d)(5). 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 subject to the
regulations of this part is informed as soon as practicable, and, in all
cases, within the 5 working days after completion of the evaluation
described in paragraphs (a)(1) or (a)(2) of this section if the
manufacture, construction, or operation of a facility or activity, a
basic component supplied for such facility or activity, or the design
certification or design approval under part 52 of this chapter--
(i) Fails to comply with the Atomic Energy Act of 1954, as amended,
or any
[[Page 446]]
applicable rule, regulation, order, or license of the Commission or
standard design approval under part 52 of this chapter, relating to a
substantial safety hazard, or
(ii) Contains a defect.
(b) If the deviation or failure to comply is discovered by a
supplier of basic components, or services associated with basic
components, and the supplier determines that it does not have the
capability to perform the evaluation to determine if a defect exists,
then the supplier must inform the purchasers or affected licensees
within five working days of this determination so that the purchasers or
affected licensees may evaluate the deviation or failure to comply,
pursuant to Sec. 21.21(a).
(c) A dedicating entity is responsible for--
(1) Identifying and evaluating deviations and reporting defects and
failures to comply associated with substantial safety hazards for
dedicated items; and
(2) Maintaining auditable records for the dedication process.
(d)(1) A director or responsible officer subject to the regulations
of this part or a person designated under Sec. 21.21(d)(5) must notify
the Commission when he or she obtains information reasonably indicating
a failure to comply or a defect affecting--
(i) The manufacture, construction or operation of a facility or an
activity within the United States that is subject to the licensing
requirements under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72 of
this chapter and that is within his or her organization's
responsibility; or
(ii) A basic component that is within his or her organization's
responsibility and is supplied for a facility or an activity within the
United States that is subject to the licensing, design certification, or
approval requirements under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or
72 of this chapter.
(2) The notification to NRC of a failure to comply or of a defect
under paragraph (d)(1) of this section and the evaluation of a failure
to comply or a defect under paragraphs (a)(1) and (a)(2) of this
section, are not required if the director or responsible officer has
actual knowledge that the Commission has been notified in writing of the
defect or the failure to comply.
(3) Notification required by paragraph (d)(1) of this section must
be made as follows--
(i) Initial notification by facsimile, which is the preferred method
of notification, to the NRC Operations Center at (301) 816-5151 or by
telephone at (301) 816-5100 within two days following receipt of
information by the director or responsible corporate officer under
paragraph (a)(1) of this section, on the identification of a defect or a
failure to comply. Verification that the facsimile has been received
should be made by calling the NRC Operations Center. This paragraph does
not apply to interim reports described in Sec. 21.21(a)(2).
(ii) Written notification to the NRC at the address specified in
Sec. 21.5 within 30 days following receipt of information by the
director or responsible corporate officer under paragraph (a)(3) of this
section, on the identification of a defect or a failure to comply.
(4) The written report required by this paragraph shall include, but
need not be limited to, 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 such facility or such activity within the United
States which fails to comply or contains a defect.
(iii) Identification of the firm constructing 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 such defect or failure to
comply.
(v) The date on which the information of such 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 these components in use at,
supplied for, being supplied for, or may be supplied for, manufactured,
or being manufactured for one or more facilities or activities subject
to the regulations in this part.
[[Page 447]]
(vii) 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.
(viii) 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 purchasers or licensees.
(ix) In the case of an early site permit, the entities to whom an
early site permit was transferred.
(5) The director or responsible officer may authorize an individual
to provide the notification required by this paragraph, provided that,
this shall not relieve the director or responsible officer of his or her
responsibility under this paragraph.
(e) Individuals subject to this part may be required by the
Commission to supply additional information related to a defect or
failure to comply. Commission action to obtain additional information
may be based on reports of defects from other reporting entities.
[42 FR 28893, June 6, 1977, as amended at 46 FR 58283, Dec. 1, 1981; 47
FR 57480, Dec. 27, 1982; 52 FR 31611, Aug. 21, 1987; 56 FR 36089, July
31, 1991; 59 FR 14086, Mar. 25, 1994; 60 FR 48374, Sept. 19, 1995; 66 FR
55790, Nov. 2, 2001; 67 FR 77652, Dec. 19, 2002; 72 FR 49487, Aug. 28,
2007]
Procurement Documents
Sec. 21.31 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 issued by
him, her or it on or after January 6, 1978, specifies, when applicable,
that the provisions of 10 CFR part 21 apply.
[60 FR 48374, Sept. 19, 1995]
Inspections, Records
Sec. 21.41 Inspections.
Each individual, corporation, partnership, dedicating entity, or
other entity subject to the regulations in this part shall permit the
Commission to inspect records, premises, activities, and basic
components as necessary to accomplish the purposes of this part.
[60 FR 48374, Sept. 19, 1995]
Sec. 21.51 Maintenance and inspection of records.
(a) Each individual, corporation, partnership, dedicating entity, or
other entity subject to the regulations in this part shall prepare and
maintain records necessary to accomplish the purposes of this part,
specifically--
(1) Retain evaluations of all deviations and failures to comply for
a minimum of five years after the date of the evaluation;
(2) Suppliers of basic components must retain any notifications sent
to purchasers and affected licensees for a minimum of five years after
the date of the notification.
(3) Suppliers of basic components must retain a record of the
purchasers of basic components for 10 years after delivery of the basic
component or service associated with a basic component.
(4) Applicants for standard design certification under subpart B of
part 52 of this chapter and others providing a design which is the
subject of a design certification, during and following Commission
adoption of a final design certification rule for that design, shall
retain any notifications sent to purchasers and affected licensees for a
minimum of 5 years after the date of the notification, and retain a
record of the purchasers for 15 years after delivery of design which is
the subject of the design certification rule or service associated with
the design.
(5) Applicants for or holders of a standard design approval under
subpart E of part 52 of this chapter and others providing a design which
is the subject of a design approval shall retain any notifications sent
to purchasers and affected licensees for a minimum of 5 years after the
date of the notification, and retain a record of the purchasers for 15
years after delivery of the design which is the subject of the design
approval or service associated with the design.
(b) Each individual, corporation, partnership, dedicating entity, or
other entity subject to the regulations in this part shall permit the
Commission
[[Page 448]]
the opportunity to inspect records pertaining to basic components that
relate to the identification and evaluation of deviations, and the
reporting of defects and failures to comply, including (but not limited
to) any advice given to purchasers or licensees on the placement,
erection, installation, operation, maintenance, modification, or
inspection of a basic component.
[56 FR 36090, July 31, 1991, as amended at 60 FR 48374, Sept. 19, 1995;
72 FR 49488, Aug. 28, 2007]
Enforcement
Sec. 21.61 Failure to notify.
(a) Any director or responsible officer of an entity (including
dedicating entity) that is not otherwise subject to the deliberate
misconduct provisions of this chapter but is subject to the regulations
in this part who knowingly and consciously fails to provide the notice
required as by Sec. 21.21 shall be subject to a civil penalty equal to
the amount provided by section 234 of the Atomic Energy Act of 1954, as
amended.
(b) Any NRC licensee or applicant for a license (including an
applicant for, or holder of, a permit), applicant for a design
certification under part 52 of this chapter during the pendency of its
application, applicant for a design certification after Commission
adoption of a final design certification rule for that design, or
applicant for or holder of a standard design approval under part 52 of
this chapter subject to the regulations in this part who fails to
provide the notice required by Sec. 21.21, or otherwise fails to comply
with the applicable requirements of this part shall be subject to a
civil penalty as provided by Section 234 of the Atomic Energy Act of
1954, as amended.
(c) The dedicating entity, pursuant to Sec. 21.21(c) of this part,
is responsible for identifying and evaluating deviations, reporting
defects and failures to comply for the dedicated item, and maintaining
auditable records of the dedication process. NRC enforcement action can
be taken for failure to identify and evaluate deviations, failure to
report defects and failures to comply, or failure to maintain auditable
records.
[60 FR 48374, Sept. 19, 1995, as amended at 72 FR 49488, Aug. 28, 2007]
Sec. 21.62 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1954, as amended,
provides for criminal sanctions for willful violation of, attempted
violation of, or conspiracy to violate, any regulation issued under
sections 161b, 161i, or 161o of the Act. For purposes of section 223,
all the regulations in part 21 are issued under one or more of sections
161b, 161i, or 161o, except for the sections listed in paragraph (b) of
this section.
(b) The regulations in part 21 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Sec. Sec. 21.1, 21.2, 21.3, 21.4 21.5, 21.7, 21.8, 21.61, and 21.62.
[57 FR 55071, Nov. 24, 1992]