[Federal Register Volume 60, Number 181 (Tuesday, September 19, 1995)]
[Rules and Regulations]
[Pages 48369-48374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23179]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 21
RIN 3150-AF01
Procurement of Commercial Grade Items by Nuclear Power Plant
Licensees
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations to provide added flexibility in procuring commercial grade
items for safety-related service by nuclear power plant licensees. This
action provides the requirements for the procurement of basic
components, which will be procured initially as commercial grade items
with subsequent dedication for safety-related service, in a manner that
avoids unnecessary delay and expense while maintaining an adequate
level of plant safety.
EFFECTIVE DATE: October 19, 1995.
ADDRESSES: Copies of the public record, including the final regulatory
analysis and any public comments received on the proposed rule, may be
examined and copied for a fee in the Commission's Public Document Room
at 2120 L Street, NW, Washington, DC.
FOR FURTHER INFORMATION CONTACT: M. L. Au, P.E., Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555, telephone (301) 415-6181; E-mail [email protected].
SUPPLEMENTARY INFORMATION:
Background
On October 24, 1994 (59 FR 53372), the NRC published a proposed
rule in the Federal Register that would clarify and add flexibility to
10 CFR Part 21 requirements for the procurement of commercial grade
items for safety-related service by nuclear power plant licensees. This
action was in response to a petition for rulemaking (PRM-21-2) from the
Nuclear Management and Resources Council (NUMARC), which has been
incorporated into the Nuclear Energy Institute (NEI). The notice of
receipt of the petition for rulemaking was published on October 14,
1993 (58 FR 53159). The petitioner contended that many of the
manufacturers and suppliers of original equipment no longer maintain
programs that meet the requirements of Appendix B, ``Quality Assurance
Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,'' to 10
CFR Part 50, ``Domestic Licensing of Production and Utilization
Facilities,'' because of the high cost of maintaining and implementing
these programs relative to the diminishing demand for plant parts.
Thus, according to NEI, an increasing number of safety-related items
are being purchased as commercial grade items from manufacturers and
suppliers who no longer maintain quality assurance programs required by
Appendix B to 10 CFR Part 50. Because this is a relatively small
market, the petitioner stated that many vendors are unwilling to
develop and maintain evaluation and notification procedures that meet
the reporting requirements in 10 CFR Part 21. With fewer vendors
agreeing to comply with these requirements, the petitioner claimed that
it is becoming increasingly difficult for nuclear power plant licensees
to procure items for safety-related applications.
The petitioner believed that the sections in 10 CFR Part 21 that
relate to procurement of commercial grade items, the dedication of
these items for use in safety-related applications, and the reporting
requirements associated with these items are unworkable and ineffective
and consequently may adversely affect safety. Furthermore, the
petitioner believed that the effect of these provisions has been to
discourage vendors from maintaining programs that meet NRC requirements
and to even refuse to provide parts to licensees. To alleviate these
problems, the petitioner proposed the following three changes to 10 CFR
Part 21:
First, the petitioner suggested that the NRC broaden the definition
of ``commercial grade item'' in 10 CFR 21.3 to read as follows:
``Commercial grade item means any item that has not been dedicated for
use as a basic component.'' Essentially this definition would cover any
item obtained on the open market. The petitioner believed that allowing
commercially available items to qualify as commercial grade items would
result in more reasonable prices and delivery times with no adverse
impacts on safe plant operations.
Second, the petitioner suggested a more flexible generic definition
of ``dedication'' in 10 CFR 21.3 to read as follows: ``Dedication is
the evaluation process undertaken to provide reasonable assurance that
a commercial grade item to be used as a basic component will perform
its intended function.'' According to the petitioner, dedication
methods could include testing, inspection, surveying the commercial
grade supplier to determine that the appropriate quality control is in
place, observing the manufacturing process, and analyzing the
historical record of the item for acceptable performance. The
petitioner also proposed that the dedicating entity maintain
documentation of the dedication process for an audit or inspection.
The petitioner believed that the benefits of establishing this
approach would be that the licensee or third-party performing the
dedication:
(1) Understands the safety significance and function of the
proposed component;
(2) Is able to identify the characteristics necessary to perform
its intended function better than the manufacturer; and
(3) Is responsible for the quality of the commercial grade item.
This would require the party performing the dedication to determine
the suitability of the component by analyzing its ability to perform
successfully in a safety-related application.
Third, the petitioner suggested that the responsibility for
reporting defects and failures to comply for commercial grade items
that have been dedicated should reside with the entity responsible for
performing the dedication process. The petitioner suggested that the
following language be added to 10 CFR 21.21(b): ``The entity that
performs the dedication is responsible for identifying, evaluating and
reporting the deviations and failures to comply associated with
substantial safety hazards of a commercial grade item.'' Since the
manufacturers, suppliers, and sub-tier suppliers of commercial grade
items do
[[Page 48370]]
not necessarily know whether the item is destined for a safety-related
application, the petitioner believes it is appropriate to clarify that
the responsibility for reporting defects and failures to comply found
in commercial grade items falls on the entity performing the dedication
process.
To sum up, the petitioner requested that 10 CFR Part 21 be amended
to:
(1) Replace the existing definition of commercial grade item with a
more inclusive definition;
(2) Include a flexible generic process for dedication of commercial
grade items for safety-related use; and
(3) Clarify that the entity performing the dedication of a
commercial grade item is responsible for discovering and evaluating
deviations and for reporting defects and failures to comply as required
by 10 CFR Part 21.
The rule grants in part and denies in part the petition for
rulemaking (PRM-21-2) from the NEI and completes action on the
petition.
Public Comment
The NRC received 23 letters of public comments in response to the
Federal Register notice announcing the receipt of the petition for
rulemaking. All but one letter supported the petition and called for a
revision of the NRC's regulations consistent with the proposal set
forth in the petition. The NRC considered these comments in the
development of the proposed rule that was published in October 1994.
The NRC received 19 letters of comment in response to the proposed
rule. The NRC considered these comments in developing the final rule,
the objective of which is to provide requirements for the procurement
of basic components, initially procured as commercial grade items and
subsequently dedicated for safety-related service, in a timely and cost
effective manner that avoids unnecessary delay and expense to the
licensee while maintaining an adequate level of plant safety.
The 19 letters of comment received in response to the proposed rule
can be categorized as follows: 1 from an interested individual, 1 from
an individual in a citizen's group, 1 from the Nuclear Energy Institute
(NEI) with a supplemental letter re-emphasizing comments important to
NEI, 1 from a law firm, 14 from nuclear power plant licensees, and 1
from a nuclear power plant supplier. Many of the letters contained
comments that were similar in nature. The majority of the commenters
were supportive of the proposed rule. Only one commenter, an individual
from a citizens group, objected to the proposed rule. The following
section summarizes the public comments received and provides NRC's
responses to the concerns expressed.
Comment. The proposed rule contains changes developed by NRC staff
which differ from the proposal originally submitted by NEI (formerly
NUMARC), and in addition, codifies new prescriptive requirements for
the dedication process.
Response. Part 21 currently does not contain a regulatory
definition of ``dedication,'' indicating only the time when dedication
occurs; however, the NEI petition sought, among other matters, to
define and establish by rulemaking a standard for the dedication
process. As such, it was appropriate for the Commission to consider the
elements of a dedication process for commercial grade items which
assure the protection of the health and safety of the public rather
than limit this standard to the industry's proposal. Therefore, it is
not inappropriate for the NRC to consider ``provisions not sought by
the petitioner.'' The NRC has never interpreted, nor has it
implemented, the 10 CFR 2.802 rulemaking petition process in a manner
which requires either the wholesale acceptance or rejection of specific
rulemaking proposals contained in a 10 CFR 2.802 petition.
Comment. Amendments to the definitions are ambiguous and do not
provide a clear demarcation between basic components and commercial
grade items. The definition of ``basic component'' raises two problems
involving wording. The definition states that it ``includes'' two
categories of items, i.e., those designed ``or'' manufactured under
Appendix B to 10 CFR Part 50 quality assurance programs, and commercial
grade items successfully dedicated as basic components. The first
problem is the use of the term ``includes'' in the definition of basic
component. This opens the possibility that other categories of items
could also exist which is not the intent. The second problem is the use
of the word ``or'' between ``design'' and ``manufactured.'' An item
designed under an Appendix B quality assurance program, but
manufactured commercial grade should not be categorized as a basic
component. It requires dedication to be categorized as a basic
component.
Response. The NRC agrees with the commenter's observation that the
Commission's intent was for the definition of basic component to be
limited to only two categories of items: (1) those designed and
manufactured under 10 CFR Part 50, Appendix B quality assurance
programs, and (2) those commercial grade items successfully dedicated
as basic components. The definition of ``basic component'' has been
revised to address the commenter's concern.
Comment. The proposed definition of ``Commercial Grade Items''
appears to be unnecessarily restrictive and could give rise to
interpretational difficulties that could limit or preclude options
available to the licensee, rather than enhance the flexibility of
licensees or utilities in dedicating commercial grade items for safety-
related applications. The difficulty with the proposed definition of
commercial grade item is that it would force utilities to always
purchase a product as nuclear grade if a manufacturer with an Appendix
B to 10 CFR Part 50 quality assurance program exists, which would
result in a monopoly or a ``captive market.''
Response. The new definition is not intended to restrict the
licensee from purchasing commercial grade items for subsequent
dedication for safety-related applications even though a basic
component designed and manufactured under an Appendix B to 10 CFR Part
50 quality assurance program is currently available. The commercial
grade item, when properly and successfully dedicated, is deemed by the
NRC to be equivalent in its safety function performance to the same or
a similar item designed and manufactured under an Appendix B to Part 50
quality assurance program.
Comment. The phrase ``or part of a basic component'' should be
deleted from the definition of commercial grade items because it could
be interpreted to mean that all commercial grade items used in basic
components are required to be dedicated for safety-related use.
Response. To address this comment, the NRC has modified the
definition of ``commercial grade item'' to clarify that a commercial
grade item that is part of a basic component but does not affect a
safety-related function need not be dedicated. Therefore, a commercial
grade item which is part of a basic component is considered to be a
basic component after it has been dedicated prior to installation only
if it affects a safety function.
Comment. The proposed new definition of ``commercial grade item''
and other changes to Part 21 should not be limited to only nuclear
power plant licensees under Part 50, and their vendors, since these
entities hold other licenses and would benefit from changes to Part 21.
Response. Proposed changes to Part 21 regulatory requirements for
[[Page 48371]]
nonreactor licensees are currently being considered.
Comment. The definition of the term ``dedication'' needs to be
clarified as it lacks flexibility for dedication of a commercial grade
item for safety-related applications. The graded approach should be
used for applying Appendix B to 10 CFR Part 50.
Response. The dedication process must be performed using the
applicable quality assurance criteria of Appendix B to 10 CFR Part 50.
Appendix B already allows the level of quality assurance implemented to
be consistent with the item's importance to safety (i.e., the graded
approach).
Comment. The complexity of an item's design or manufacturing
process should not be a criterion for excluding commercial grade items
from eligibility to undergo a dedication process.
Response. To the extent the term ``complexity'' has caused
confusion, the language of the rule has been modified to remove that
term. The NRC maintains that if the design of an item and its
manufacturing process are such that the dedication process cannot
reasonably ensure the absence of a defect or failure to comply that
affects one or more critical characteristics of the item, then the item
cannot be dedicated, and must be designed and manufactured as a basic
component. Included are items for which the manufacturing process
requires in-process inspections and verifications to ensure that
defects are identified and corrected. Typical examples include, but are
not limited to, fuel assemblies, control rod assemblies, and reactor
coolant pressure boundary components.
Comment. In the definition of term ``dedication,'' the example of
``pressure vessels'' does not meet the specific nuclear-unique
requirement since pressure vessels are used widely outside the nuclear
industry and should be considered a potential candidate for dedication.
Response. The example is no longer included in the definition. In
the Statement of Considerations, ``pressure vessel'' has been replaced
with ``reactor coolant pressure boundary components'' since the NRC
believes such components, due to their importance to safety, should
continue to be designed and manufactured as basic components under an
Appendix B quality assurance program.
Comment. In the definition of ``dedicating entity,'' the word
``qualify'' should be replaced with the word ``accept'' to ensure that
the dedication process is differentiated from equipment qualification.
Response. The NRC agrees that the word ``qualify'' could lead to
misinterpretation. The definition of ``dedicating entity'' has been
revised.
Comment. The proposed definition of ``critical characteristics''
should not be codified for two reasons. First, it is not necessary or
beneficial to codify the processes. Second, the term was originally
developed by industry to support improved dedication and procurement
programs under NUMARC procurement initiatives. There are fundamental
differences in the interpretation of the term ``critical
characteristics'' between the NRC and much of the nuclear industry.
Response. The NRC believes it is important to define and codify
``critical characteristics'' because this term represents a subject of
importance in the dedication process for commercial grade items. The
Commission is aware that in the Electric Power Research Institute's
(EPRI) ``Guideline for the Utilization of Commercial Grade Items in
Nuclear Safety Related Applications,'' EPRI NP-5652, ``critical
characteristics'' is defined primarily in procurement terms, i.e., that
the item received is the item specified as verified by part number.
However, in the Commission's view, this is an appropriate term by which
to convey the intent of this rulemaking that the dedication process
specify those characteristics important to the design, material, and
performance of an item so that the verification of those
characteristics will provide reasonable assurance that the item will
perform its intended safety function.
Comment. One utility commented that a backfit analysis should be
required because new requirements for dedication are being specified.
Response: The current Part 21 regulation already provides for the
dedication of commercial grade items to be used in safety-related
applications. The final rule provides for a broadening of the
definition of commercial grade items and their subsequent dedication
for safety-related service. The rule does not impose a more restrictive
requirement upon any licensee or dedicating entity; therefore, it does
not constitute a backfit as defined in 10 CFR 50.109(a)(1), and no
backfit analysis is necessary.
Comment. Part 21 does not clearly address the responsibilities for
reporting defects and failures to comply associated with the purchase
and subsequent transfer of a basic component by one utility to another.
A provision should be included in the rulemaking allowing one utility
to accept an item as a basic component when the utility supplying the
item is unwilling to accept the Part 21 responsibilities associated
with this kind of transaction. The utility purchasing the item should
document the qualification of the vendor during the time of original
manufacture and sale of the item.
Response: The NRC does not agree with the position set forth in
this comment. The Part 21 regulation specifies the responsibilities of
any individual or corporation and each director and responsible officer
of such organization that supplies basic components. Those
responsibilities are also applicable to utilities which supply basic
components to other utilities. Nothing in the regulation prevents a
utility from contacting the original supplier or manufacturer for the
direct transfer of information regarding the item.
Basis for Commission's Decision
The NRC has reviewed the public comments that were submitted on the
proposed rule. The final rule has taken into consideration many of the
suggested changes as indicated in this Statement of Considerations.
When Part 21 was first issued in 1977, the suppliers of all parts
making up a basic component were subject to the reporting requirements
under Part 21. However, recognizing that the Commission lacked
experience in implementing a reporting program of this scope, the
Commission also pointed out in the Statement of Considerations
accompanying this part that it would examine closely the implementation
of Part 21 as the Commission gained experience. Following the issuance
of Part 21, the NRC received many requests for clarification of the
regulations. The NRC examined the issue of how far down the procurement
chain Part 21 should be applicable and on October 19, 1978 (43 FR
4862), amended Part 21 to exempt commercial grade items from the
reporting requirements of Part 21 until the items were dedicated for
use as a basic component. The NRC held that the October 1978 rule was
needed for safety reasons. Problems such as the inability to obtain
needed parts and services were all cited as detriments to safety. The
NRC was challenged on this amendment and the court of appeals upheld
the Commission's interpretation of section 206 of the ERA requiring the
Commission to ``draw a line somewhere to demarcate the outer boundaries
of the duty to report'' (Natural Resources Council v. NRC, 666 F.2d 595
(D.C. Cir. 1981)).
Problems such as the inability to obtain parts and services from
the most qualified suppliers and excessive delays
[[Page 48372]]
in procurements were all cited as detriments to safety. With the
development of increased confidence in licensee implementation of
dedication activities through NRC inspection and experience, and
because the availability of basic components has further declined, the
NRC believes that the current definition of commercial grade items has
become unnecessarily restrictive.
The petitioner proposed that a commercial grade item be defined as
any item that has not been dedicated for use as a basic component.
Thus, any commercial grade item could be subject to a dedication
process to verify its qualification as a basic component. The
Commission maintains that not all commercial grade items can be
properly dedicated for safety-related use after the manufacturing
process is completed. In fact several commenters agreed that there is a
limited category of components for which quality assurance is an
integral part of the manufacturing process and that their critical
characteristics cannot be attested to after-the-fact. The Commission
believes that if the design or manufacturing process of an item is such
that dedication cannot reasonably assure the absence of a defect that
could affect one or more critical characteristics of the item, the item
must be designed and manufactured as a basic component in accordance
with 10 CFR Part 50, Appendix B requirements. There are components in
this limited category that generally have requirements and applications
in which the design and manufacturing processes require in-process
inspections and verifications to ensure that defects and failures to
comply are identified and corrected. Thus, the NRC believes that
commercial grade items cannot encompass the full spectrum of items
envisioned by the petitioner.
Part 21 currently defines a commercial grade item as an item that
is (1) Not subject to nuclear-unique design or specification
requirements; (2) used in applications outside the nuclear industry;
and (3) ordered on the basis of specifications set forth in the
manufacturer's published product description. This set of conditions
resulted in very limited use of the commercial grade item designation.
To provide added flexibility in using commercial grade items for
safety-related service by nuclear power plant licensees, the NRC is
replacing the set of conditions and adopted a new definition for
commercial grade item. Under this new definition, a ``commercial grade
item,'' when applied to nuclear power plants, means a structure,
system, or component, or part thereof that affects its safety function,
that was not designed and manufactured as a basic component. The
definition makes clear that a commercial grade item that is part of a
basic component but does not affect a safety-related function need not
be dedicated and that item is not considered a basic component.
Commercial grade items do not include items in which their 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). Typical examples include, but are not limited to,
fuel assemblies, control rod assemblies, and reactor coolant pressure
boundary components. Thus the definition of ``commercial grade item''
does not include items whose quality assurance is an integral part of
the manufacturing process and whose acceptance is based primarily on
the vendor's certification of compliance with specific design
requirements. For facilities and activities licensed pursuant to 10 CFR
Parts 30, 40, 50 (other than nuclear power plants), 60, 61, 70, 71, or
72, the existing definition is retained, although proposed revisions to
Part 21 for application to these facilities and activities (including
those certified under 10 CFR Part 76) are under consideration in a
separate rulemaking.
The new definition is not intended to restrict the licensee from
purchasing commercial grade items for subsequent dedication for safety-
related applications even though a basic component designed and
manufactured under an Appendix B to 10 CFR Part 50 quality assurance
program is currently available. The commercial grade item, when
properly and successfully dedicated, is deemed by the NRC to be
equivalent in its safety function performance to the same or a similar
item designed and manufactured under an Appendix B to Part 50 quality
assurance program.
Sections 21.6, 21.21, 21.31, 21.41, and 21.51 contain the NRC's
requirements for posting, notification, inspection, records, and
maintenance and inspection of records, respectively. The NRC is
clarifying these sections to point out that dedicating entities are
subject to the regulations in these sections. In addition, minor
editorial changes have been made in Sec. 21.51(b).
Section 21.61 has been amended to clarify the scope of this
section. NRC licensees and their employees subject to Part 21 are also
subject to the normal enforcement process and sanctions. In addition,
Section 206 of the Energy Reorganization Act of 1974, as amended, and
implemented by 10 CFR Part 21, imposes an obligation on firms and
organizations that are involved in the nuclear industry, and further,
imposes these obligations as a direct liability on certain individuals
in these firms and organizations. The ``knowingly and consciously''
standard specified in Sec. 21.61 applies only to non-licensees.
Environmental Impact: Categorical Exclusion
The NRC has determined that this regulation is the type of action
described in the categorical exclusion in 10 CFR 51.22(c)(1).
Therefore, neither an environmental impact statement nor an
environmental assessment has been prepared for this regulation.
Paperwork Reduction Act Statement
This rule does not contain a new information collection requirement
subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et
seq.). Existing requirements were approved by the Office of Management
and Budget approval number 3150-0035.
Regulatory Analysis
The Commission has prepared a regulatory analysis on this
regulation. The analysis examines the costs and benefits of the
alternatives considered by the Commission. The analysis is available
for inspection in the NRC Public Document Room, 2120 L Street NW.
(Lower Level), Washington, DC. Single copies may be obtained from (See
For Further Information Contact.)
Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule, if promulgated, will
not have a significant economic impact on a substantial number of small
entities. The rule primarily impacts nuclear power plant licensees
because they are expected to assume a greater role in the dedication
process. The companies that own these plants do not fall within the
scope of the definition of ``small entities'' set forth in the
Regulatory Flexibility Act or the size standards established by the NRC
(10 CFR 2.810). In addition, the rule, when promulgated, will allow
small entities to more effectively compete in providing components and
services to nuclear power plants, and to the extent this occurs, the
rule is advantageous to them.
[[Page 48373]]
Backfit Analysis
The Commission has determined that the backfit rule, 10 CFR 50.109,
does not apply to this rule. These amendments do not involve any
provision that would impose additional requirements requiring a backfit
analysis as defined in 10 CFR 50.109(a)(1).
List of Subjects in 10 CFR Part 21
Nuclear power plants and reactors, Penalties, Radiation protection,
Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended, the Energy Reorganization
Act of 1974 as amended, and 5 U.S.C. 552 and 553, the NRC is adopting
the following amendments to 10 CFR Part 21.
PART 21--REPORTING OF DEFECTS AND NONCOMPLIANCE
1. The authority citation for Part 21 continues to read as follows:
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).
Section 21.2 also issued under secs. 135, 141, Pub. L. 97-425,
96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
Sec. 21.2 [Amended]
2. Section 21.2 (d) is amended by revising the reference reading
``(see Sec. 21.3(a-1)'' to read ``(as defined in Sec. 21.3),'' and in
the third sentence of this section, change the word ``five'' to
``four.''
3. Section 21.3 is amended by removing the paragraph designations
from each of the defined terms and arranging the definitions in
alphabetical order, removing the words ``paragraph (d)(1) of'' in
paragraph (2) of the term Defect, removing the parenthetical references
in the terms Defect and Deviation, revising the terms Basic component,
Commercial grade item, and Dedication, and adding the terms Critical
characteristics and Dedication entity to read as follows:
Sec. 21.3 Definitions.
Basic component. (1)(i) When applied to nuclear power plants
licensed pursuant to 10 CFR Part 50 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. 100.11 of this chapter.
(ii) Basic components are items designed and manufactured under a
quality assurance program complying with 10 CFR Part 50, Appendix B, or
commercial grade items which have successfully completed the dedication
process.
(2) When applied to other facilities and when applied to other
activities licensed pursuant to 10 CFR Parts 30, 40, 50 (other than
nuclear power plants), 60, 61, 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.
(3) 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
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, 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).
* * * * *
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.
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, 70,
71, or 72, dedication occurs after receipt when that item is designated
for use as a basic component.
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.
* * * * *
3. In Sec. 21.6, paragraph (a) is revised to read as follows:
[[Page 48374]]
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
(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.
* * * * *
4. In Sec. 21.21, the introductory text of paragraph (a) is
revised, paragraphs (c) and (d) are redesignated as paragraphs (d) and
(e), and a new paragraph (c) is added to read as follows:
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--
* * * * *
(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.
* * * * *
5. Section 21.31 is revised to read as follows:
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.
6. Section 21.41 is revised to read as follows:
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.
7. In Sec. 21.51 the introductory text of paragraph (a) and
paragraph (b) are revised to read as follows:
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--
* * * * *
(b) Each individual, corporation, partnership, dedicating entity,
or other entity subject to the regulations in this part shall permit
the Commission 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 any advice given to purchasers or licensees on the placement,
erection, installation, operation, maintenance, modification, or
inspection of a basic component.
8. Section 21.61 is revised to read as follows:
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 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.
Dated at Rockville, Maryland, this 8th day of September 1995.
For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 95-23179 Filed 9-18-95; 8:45 am]
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