[Federal Register Volume 59, Number 204 (Monday, October 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25707]
[[Page Unknown]]
[Federal Register: October 24, 1994]
VOL. 59, NO. 204
Monday, October 24, 1994
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: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations in 10 CFR Part 21 to clarify and add flexibility to the
process of procuring commercial grade items for safety-related service
by nuclear power plant licensees. The proposed rule expands the scope
of commercial grade items to encompass all items procured for use in
safety-related service that are not designed and/or manufactured as
basic components. This proposed rule is necessary to ensure that the
procurement of commercial grade parts and their subsequent dedication
are performed in a manner that avoids unnecessary delay and expense
while maintaining an adequate level of plant safety. The proposed rule
responds to a petition for rulemaking from the Nuclear Management and
Resources Council (NUMARC), which is now incorporated into the Nuclear
Energy Institute (NEI).
DATES: Submit comments by January 9, 1995. Comments received after this
date will be considered if it is practical to do so, but the Commission
is able to assure consideration only for comments received on or before
this date.
ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555. Attn: Docketing and Service Branch.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland, between 7:45 a.m. and 4:15 p.m. on Federal workdays.
Examine comments received and the regulatory analysis at: The NRC
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Obtain single copies of the regulatory analysis from: M.L. Au,
Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, telephone (301) 415-6181.
FOR FURTHER INFORMATION CONTACT: M.L. Au, Office of Nuclear Regulatory
Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555,
telephone (301) 415-6181.
SUPPLEMENTARY INFORMATION:
Background
The Commission issued 10 CFR Part 21 on June 6, 1977 (42 FR 28893),
to implement Section 206 of the Energy Reorganization Act of 1974. One
of the purposes of 10 CFR Part 21 is to provide for the evaluation of
deviations, and reporting of defects and failures to comply in safety-
related parts and services for use in nuclear power plants. 10 CFR Part
21 is implemented in conjunction with 10 CFR Part 50, Appendix B, which
contains the quality assurance criteria to be applied to design,
fabrication, construction, and testing of safety-related structures,
systems, and components in nuclear power plants.
On October 14, 1993 (58 FR 53159), the Commission published a
notice of receipt of a petition for rulemaking (PRM-21-2) from the
Nuclear Management and Resources Council (NUMARC), which is now
incorporated into the Nuclear Energy Institute (NEI). The NUMARC
petition was docketed by the NRC on June 22, 1993.
The petitioner requested that the Commission amend 10 CFR Part 21
to clarify and add flexibility to the process of procuring commercial
grade items for safety-related service by nuclear power plant
licensees. Specifically, 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 reporting defects and failures to comply as required by
10 CFR Part 21.
Basis for Petition
The petitioner contends that many of the original equipment
manufacturers and suppliers no longer maintain programs that meet the
requirements in 10 CFR Part 50, Appendix B, due to the high cost of
maintaining and implementing these programs relative to the diminishing
demand for plant parts. Thus, an increasing number of safety-related
parts are being purchased from manufacturers and suppliers who no
longer maintain quality assurance programs pursuant to 10 CFR Part 50,
Appendix B. Because, this is a relatively small market, the petitioner
states that many vendors are unwilling to develop and maintain
evaluation and notification procedures that meet 10 CFR Part 21
reporting requirements. With fewer vendors agreeing to comply with
these requirements, the petitioner claims that it is becoming difficult
for nuclear power plant licensees to procure an increasing number of
items and services for safety-related applications.
10 CFR Part 21 currently provides an exemption for a subclass of
components called ``commercial grade.'' These components are defined as
items that are (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 (for example,
a catalog).
The petitioner believes that the discussions in 10 CFR Part 21 that
relate to 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
believes 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 proposes the following three changes to 10 CFR Part 21:
First, the petitioner suggests 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.'' This definition essentially would include
any item obtained on the open market. The petitioner believes 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 suggests a more flexible generic definition
of ``dedication'' in 10 CFR 21.3: ``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 and/or 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
proposes that the dedicating entity maintain documentation of the
dedication process for the purpose of an audit or inspection.
The petitioner believes that the benefits of establishing this
process are that the utility 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)
would be 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 the effect of its performance
in a safety-related application.
Third, the petitioner suggests that the responsibility for
reporting defects and failures to comply for commercial grade items
should reside with the entity responsible for performing the dedication
process. The petitioner suggests 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.'' The petitioner believes that it is appropriate
to clarify that the responsibility for reporting defects and failures
to comply for commercial grade items falls on the entity performing the
dedication process because the suppliers and sub-tier suppliers do not
necessarily know whether a commercial grade item is destined for a
safety-related application.
Public Comments and Responses
The NRC received 23 letters in response to the publication of the
notice of receipt of the petition. All but one letter supported the
petition and called for a revision of the NRC's regulations consistent
with the proposed amendments set forth in the petition.
Of the 22 letters that supported the petition, 17 supported the
proposed amendments without any qualification. Fifteen of these letters
were from nuclear utilities and two from nuclear vendors.
The five other supportive letters recommended minor changes to the
specific language of the proposed amendments. With respect to the
definition of dedication, one commenter recommended replacing
``intended function'' with ``intended safety-related function.'' The
intent here is to make it clear that a dedicating entity must focus on
safety-related functions in determining whether an item will be
suitable as a basic component. During the comment period, NUMARC
indicated its support for this change. The NRC also concurs that this
is an appropriate clarification. In addition, three commenters offered
a clarifying second sentence that would establish the point in time
that an item is considered dedicated. The sentence would indicate that,
when dedication of a commercial grade item has been completed, the item
may be used as a basic component. One of these commenters also
recommended that the term ``evaluation'' be eliminated from the first
sentence because the definition of ``evaluation'' is currently provided
in 10 CFR 21.3 and has a different intent than its use here. The NRC
supports inclusion of the additional sentence. The NRC also agrees with
the commenter regarding removal of the term ``evaluation.'' This term
will continue to be used only in conjunction with a substantial safety
hazard determination.
Two commenters recommended changes to the notification requirement
to prevent confusion regarding the application of 10 CFR Part 21 only
to basic components. The NRC agrees with the substance of the comment
to provide for the notification of defects and failures to comply only
subsequent to successful dedication of the commercial grade item as a
basic component.
One commenter expressed concern that a supplier's responsibility
for procurement documentation is not clear. The commenter recommended
that procurement documents specify that an item is commercial grade,
that dedication would be performed by the purchaser, and that
provisions of 10 CFR Part 21 would not apply to the supplier. The NRC
believes 10 CFR 21.31 clearly states that only procurement documents
for the purchase of basic components and commercial grade items which
have been designated for use as basic components through the dedication
process must adhere to the provisions of 10 CFR Part 21.
The one letter in opposition to the petition was submitted by a
private individual. This commenter believes that commercial grade
dedication requires each utility to perform a comprehensive evaluation
and to establish the appropriate engineering and quality requirements
utilizing the provisions of 10 CFR Part 50, Appendix B. Further, this
commenter also states that 10 CFR Part 21 should not be used as an
instructional guide for the engineering analysis and procurement of
items. The NRC believes that proposed revisions to 10 CFR Part 21 will
reflect the current procurement situation faced by utilities while
enhancing the requirement for ensuring proper qualification of
commercial grade items used in safety-related applications.
Basis for Commission's Decision
The NRC has carefully reviewed the arguments presented by the
petitioner and the public comments that were submitted on the petition.
The NRC is proposing to grant the petition in part with regard to 10
CFR Part 50 licensees by initiating this rulemaking. The proposed rule
incorporates the petition in part, and modifies the petitioner's
suggested language as indicated in the following discussion.
Commercial Grade Item (CGI)
The NRC agrees in principle with the petitioner that the definition
of a commercial grade item as it relates to 10 CFR Part 50 needs to be
expanded to allow for a broader range of parts and services. In October
1978, when the NRC issued an immediately effective rule defining
commercial grade item, it was for the purpose of exempting these items
from the reporting requirements of 10 CFR Part 21 until their
dedication as basic components. The NRC argued that this amendment was
needed for safety reasons. Problems such as the inability to obtain
needed supplies or to use the most qualified suppliers, and excessive
delays in procurements were all cited as detriments to safety. The NRC
believes that similar concerns are again present to some extent because
the availability of basic components has declined and the current
definition of commercial grade item is now unnecessarily restrictive.
The petitioner proposes 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 assure its qualification as a basic component. The
Commission maintains that not all safety-related items can be properly
dedicated after the manufacturing process is completed. For certain
items, quality assurance is an integral part of the manufacturing
process and cannot be attested to after the fact. The NRC believes that
if the complexity of the design and/or manufacturing process of an item
is such that dedication cannot reasonably assure the absence of a
defect which could affect one or more critical characteristics of the
item, the item must be designed and manufactured as a basic component.
Items in this category include complex assemblies which generally have
nuclear unique requirements and applications and where the design
and/or manufacturing process requires many in-process inspections and
verifications to assure that defects are identified and corrected.
Specific examples include, but are not limited to, fuel and control rod
assemblies and pressure vessels. Thus, the NRC believes that commercial
grade items cannot encompass the full spectrum of items envisioned by
the petitioner.
10 CFR 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
results in very limited use of the commercial grade item designation.
The NRC is proposing that, for 10 CFR Part 50 licensees, an item would
qualify as a commercial grade item if it is not designed and/or
manufactured as a basic component. This would effectively preclude
inclusion of 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,
60, 61, 71, or 72 the existing definition is retained, although
proposed revisions to 10 CFR Part 21 for non-reactor licensees are
under development in a separate rulemaking.
The NRC's proposed definition of ``Commercial Grade Item,'' when
applied to facilities and activities licensed pursuant to 10 CFR Part
50, means a structure, system, component, or part thereof that is not
designed and/or manufactured as a basic component. A commercial grade
item is not a basic component or part of a basic component, until the
dedication process has been completed.
Basic Component
Because the NRC is now proposing a definition of commercial grade
item for 10 CFR Part 50 licensees in terms of the standards involved
during its design and manufacture, it is also appropriate to define
basic component in a similar manner. Therefore, the NRC proposes to add
the following sentence to its definition of ``basic component'':
``This definition includes items designed and/or manufactured under
a program complying with 10 CFR Part 50, Appendix B, and commercial
grade items which have been successfully dedicated to be used as basic
components pursuant to the dedication process described in this part.''
Dedication Process
Dedication is an inspection and acceptance process by which a
commercial grade item is designated for use as a basic component. By
expanding the scope of commercial grade items for 10 CFR Part 50
licensees, it is anticipated that an increasing number of safety-
related items will be procured as commercial grade items as opposed to
basic components. This should result in increased reliance on
dedication by licensees or third-party dedicating entities in lieu of
the quality assurance programs of manufacturers and suppliers. Although
such a transfer may be beneficial in some instances, the NRC needs
greater assurance that 10 CFR Part 50 licensees or dedicating entities
are performing meaningful and substantive dedication processes. In all
cases, the licensee using the dedicated item is responsible for
ensuring that the dedication process includes the identification and
verification of critical characteristics and is to be conducted in
accordance with the applicable provisions of 10 CFR Part 50, Appendix
B. The critical characteristics are those design, material, and
performance characteristics that, when verified, will provide
reasonable assurance that the item will perform its intended safety-
related function. As a result, the NRC believes that the rule needs to
specify the key elements of such a dedication process. Specifically,
the NRC maintains that this process must be performed in accordance
with the applicable provisions of 10 CFR Part 50, Appendix B, and
encompass inspections, tests, and/or analyses performed by the licensee
or a third-party dedicating entity after delivery, supplemented as
necessary, by a combination of commercial grade surveys, product
inspections or witness/holdpoints, and analysis of historical records
for acceptable performance. The four acceptance methods described in
EPRI NP-5652, ``Guidelines for the Utilization of Commercial-Grade
Items in Nuclear Safety-Related Applications (NCIG-07),'' as
conditionally endorsed by NRC Generic Letter 91-05, ``Licensee
Commercial-Grade Procurement and Dedication Programs,'' may be utilized
as guidance for the dedication of commercial grade items for safety-
related applications.
The petitioner also requested that the entity performing the
dedication process be responsible for 10 CFR Part 21 evaluation and
reporting requirements. The NRC concurs with this recommendation as it
will add needed flexibility in the procurement of replacement parts.
Further, the NRC believes that the dedicating entity would be the most
qualified party to assume the responsibility for 10 CFR Part 21
requirements because in many cases the commercial grade supplier does
not know the end application or safety function of the item. The
dedicating entity will generate the necessary quality records during
the dedication process, and should have a full understanding of the
items's safety function to enable that entity to perform the deviation
evaluation and defect reporting functions required under 10 CFR Part
21.
The dedicating entity, i.e., either (1) the manufacturer, (2)
third-party entity, distributing a commercial grade item which it has
successfully dedicated, or (3) licensee which has successfully
dedicated a commercial grade item for its own use, would be subject to
NRC enforcement action for failure to identify and evaluate deviations,
failure to report defects and failures to comply, or failure to
maintain auditable records. In addition, if the dedicating entity
identifies a defect which previously was not identified and which is
attributable to a flaw in the dedication process, any known recipients
of similar dedicated items using this process must be notified or
included in the dedicating entity's notification to the Commission as
currently required under the provisions of Part 50, Appendix B,
Criterion XV.
Critical Characteristics
The NRC definition of the dedication process includes the term
``critical characteristics.'' Given its import, the NRC believes it
should be defined so as to assure proper and complete identification of
those characteristics which need to be examined. Therefore, a
definition of the term ``critical characteristics'' has been added. As
noted in the proposed definition, the characteristics to be examined
are selected design, material and performance characteristics.
Dedicating Entity
The NRC definition of the dedication process also includes the term
``dedicating entity.'' Because the dedication process begins with the
dedicating entity, the NRC believes that it is important to clearly
identify the party and its responsibilities for the requirements
associated with this process. Therefore, the NRC is proposing a
definition of ``dedicating entity.''
Notification, Inspection, and Reporting Responsibilities
Section 21.21(c) (1) and (2) have been added to clarify that the
dedicating entity of a commercial grade item is responsible for
identifying and evaluating deviations, and reporting defects and
failures to comply as required by 10 CFR Part 21, as well as
maintaining auditable records of the dedication process.
Sections 21.21, 21.41, and 21.51 contain the NRC's requirements for
notification, inspections, records, and maintenance and inspection of
records, respectively. The NRC proposes, for clarification purposes,
that these sections explicitly identify dedicating entities as being
subject to the regulations in these sections. The phrase, ``(including
dedicating entities)'' has been added to Secs. 21.6(a), 21.21(a),
21.31, 21.41, and 21.51 (a) and (b). In addition, minor editorial
changes have been made in Sec. 21.51(b).
Environmental Impact: Categorical Exclusion
The NRC has determined that this proposed regulation is the type of
action described in the categorical exclusion in 10 CFR
51.22(c)(3)(iii). Therefore, neither an environmental impact statement
nor an environmental assessment has been prepared for this proposed
regulation.
Paperwork Reduction Act Statement
This proposed 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 under approval number 3150-0035.
Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed regulation. The analysis examines the costs and benefits of
the alternatives considered by the Commission. The draft analysis is
available for inspection in the NRC Public Document Room, 2120 L Street
NW. (Lower Level), Washington, DC. Single copies of the analysis may be
obtained from M.L. Au, Office of Nuclear Regulatory Research, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, telephone (301)
415-6181.
The Commission requests public comment on the draft analysis.
Comments on the draft analysis may be submitted to the NRC as indicated
under the ADDRESSES heading.
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 proposed 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 Small Business Size Standards set
out in regulations issued by the Small Business Administration at 13
CFR Part 121. In addition, the rule, if promulgated, would potentially
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.
Backfit Analysis
The Commission has determined that the backfit rule, 10 CFR Part
50.109, does not apply to this proposed rule. These amendments do not
involve any provision that would impose additional requirements
requiring a backfit analysis as defined in 10 CFR Part 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. 553, the NRC is proposing to
adopt 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 (42 U.S.C. 2201, 2282); 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).
2. Section 21.3 is amended by removing the paragraph designations
from each of the defined terms and arranging the definitions in
alphabetical order; revising the terms Basic component, Commercial
grade item and Dedication; and adding the terms Critical
characteristics and Dedicating entity to read as follows:
Sec. 21.3 Definitions.
Basic component. (1) When applied to facilities and activities
licensed pursuant to 10 CFR Part 50 of this chapter, this definition
includes items designed and/or manufactured under a quality assurance
program complying with 10 CFR Part 50, Appendix B, and commercial grade
items which have been successfully dedicated to be used as basic
components pursuant to the dedication process described in this part.
This means a plant structure, system, component or part thereof
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. 100.11 of this chapter.
(2) When applied to other facilities and when applied to other
activities licensed pursuant to 10 CFR Parts 30, 40, 60, 61, 70, 71, or
72 of this chapter, means a component, structure, system, or part
thereof that is directly procured by the licensee of a facility or
activity subject to the regulations in this part and in which a defect
(see Sec. 21.3) or failure to comply with any applicable regulation in
this chapter, order, or license issued by the Commission could create a
substantial safety hazard (see Sec. 21.3).
(3) In all cases, basic component includes safety related design,
analysis, inspection, testing, fabrication, replacement 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 facilities and
activities licensed pursuant to 10 CFR Part 50, means a structure,
system, component, or part thereof that is not designed and
manufactured as a basic component. A commercial grade item is not a
basic component, or part of a basic component, until the dedication
process has been completed.
(2) When applied to facilities and activities licensed pursuant to
10 CFR Parts 30, 40, 60, 61, 70, 71, or 72, 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 facilities and activities
licensed pursuant to 10 CFR Part 50, 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 facilities and activities licensed
pursuant to 10 CFR Part 50, is an inspection and acceptance process
undertaken to provide reasonable assurance that a commercial grade item
to be used as a basic component will perform its intended safety-
related function and, in this respect, is equivalent to an item
designed and manufactured under a 10 CFR Part 50, Appendix B quality
assurance program. This assurance is achieved by a combination of
commercial grade surveys, product inspections or witness/holdpoints at
the manufacturer's facility supplemented as required by additional
inspections or tests, or analyses of acceptable historical performance
by the purchaser or a third-party dedicating entity after delivery. In
all cases, the licensee using the dedicated item is responsible for
ensuring that the dedication process includes the identification and
verification of critical characteristics and is 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. Due to the complexity of their design and/or
manufacturing process, certain items must be designed and manufactured
as basic components since the dedication process cannot reasonably
assure the successful performance of the safety function (i.e., one or
more critical characteristic of the item cannot be verified). Items in
this category include complex assemblies which generally have nuclear
unique applications and where the design and/or manufacturing process
requires many in-process inspections and verifications to assure that
defects or failures to comply are identified and corrected. Specific
examples include, but are not limited to, fuel and control rod
assemblies and pressure vessels.
(2) When applied to facilities and activities licensed pursuant to
10 CFR Parts 30, 40, 60, 61, 70, 71, or 72, occurs after receipt when
that item is designated for use as a basic component.
Dedicating entity. When applied to facilities and activities
licensed pursuant to 10 CFR Part 50, means the organization that
performs the dedication process to qualify a commercial grade item as a
basic component. Dedication may be performed by either 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 for 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.
* * * * *
3. In Section 21.6, paragraph (a) is revised to read as follows:
Sec. 21.6 Posting requirements.
(a) Each individual, partnership, corporation or other entity
(including dedicating entities) subject to the regulations in this
part, shall post current copies of the following documents in a
conspicuous position on any premises, within the United States where
the activities subject to this part are conducted:
(1) The regulations in this part,
(2) Section 206 of the Energy Reorganization Act of 1974, and
(3) Procedures adopted pursuant to the regulations in this part.
* * * * *
4. In Section 21.21, the introductory text of paragraph (a) is
revised, paragraphs (c) and (d) are redesignated as paragraphs (d) and
(e) respectively and 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 or other entity
(including dedicating entities) 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 or other entity
(including dedicating entities) subject to the regulations in this part
shall assure that each procurement document for a facility, or a basic
component issued 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 or other entity
(including dedicating entities) 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 Section 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, or other entity
(including dedicating entities) 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, or other entity
(including dedicating entities) 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.
Dated at Rockville, Maryland, this 7th day of October 1994.
For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 94-25707 Filed 10-21-94; 8:45 am]
BILLING CODE 7590-01-P
