[Federal Register Volume 59, Number 65 (Tuesday, April 5, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8123]
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[Federal Register: April 5, 1994]
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DEPARTMENT OF ENERGY
10 CFR Part 830
RIN: 1901-AA34
Nuclear Safety Management
AGENCY: Department of Energy (DOE).
ACTION: Final rule.
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SUMMARY: The Department of Energy (DOE) is issuing a final rule
regarding Nuclear Safety Management. This Part establishes requirements
for the safe management of DOE contractor and subcontractor work at the
Department's nuclear facilities. Today's rule adopts the sections that
will make up the generally applicable provisions and also adopts the
specific section on provisions for developing and implementing a
formalized quality assurance program.
EFFECTIVE DATE: This regulation becomes effective May 5, 1994.
FOR FURTHER INFORMATION CONTACT: Frank Hawkins, U.S. Department of
Energy, Nuclear Safety Policy Division, EH-62, GTN, 1000 Independence
Avenue, SW., Washington, DC 20585, (301) 903-2476, or Ben McRae, U.S.
Department of Energy, Office of General Counsel, GC-31, FORS, 1000
Independence Avenue, SW., Washington, DC 20585, (202) 586-6975.
SUPPLEMENTARY INFORMATION:
I. Background
II. Response to Comments
A. Part 830, General Comments
B. General Provisions
C. Quality Assurance Requirements Section 830.120
III. Final Rule
IV. Procedural Requirements
A. Review Under Executive Order 12866
B. Review Under the Regulatory Flexibility Act
C. Review Under the Paperwork Reduction Act
D. Review Under the National Environmental Policy Act
E. Review Under Executive Order 12612
F. Review Under Executive Order 12778
I. Background
On December 9, 1991, DOE published proposed regulations adding Part
830 to Title 10 of the Code of Federal Regulations in order to
establish a body of rules for the safe management of DOE nuclear
facilities (``December Notice,'' 56 FR 64316). The December Notice
addressed nine specific areas related to nuclear safety: (1) Safety
Analysis Reports, (2) Unreviewed Safety Questions, (3) Quality
Assurance Requirements, (4) Defect Identification, (5) Conduct of
Operations, (6) Technical Safety Requirements, (7) Training, (8)
Maintenance, and (9) Operational Occurrences.
DOE received written comments from 29 groups on the December Notice
and held a public hearing in Germantown, Maryland, on February 25,
1992, at which five persons provided oral comments. After reviewing the
written and oral comments, DOE has decided to issue a final rule on the
sections relating to the general provisions and the quality assurance
requirements. DOE will issue final rules on the remaining proposed
sections of Part 830 as it completes its analysis of the individual
sections and the comments thereon.
In order to implement the section on ``Quality Assurance
Requirements,'' it is necessary to also issue the final rules on the
generally applicable provisions of part 830, Secs. 830.1 through 830.7
and Sec. 830.100, ``Scope of subpart.''
Seventy-eight comments were received on the ``Quality Assurance
Requirements'' section.
II. Response to Comments
DOE has analyzed the comments on the December Notice as they relate
to: (A) Part 830, general comments; (B) the general provisions; and (C)
the quality assurance requirements. Section II.A. summarizes the
general comments and DOE's responses; Section II.B. summarizes comments
and the Department's responses to the general provisions in Secs. 830.1
through 830.7; and Section II.C. summarizes comments and the
Department's responses to the quality assurance requirements in
Sec. 830.120. DOE will provide its responses to comments on other
proposed sections in the December Notice when it issues those sections
as final rules.
A. Part 830, General Comments
1. Several comments concerned the statutory authority for part 830.
These concerns related to the authority for adopting the proposed
rules and especially to the authority for imposing civil penalties for
violations of part 830. Some of the comments implied that the authority
to adopt rules on the safe management of DOE nuclear facilities was
related to the authority to impose civil penalties.
Response: Section 161 of the Atomic Energy Act (AEA) of 1954, as
amended (42 U.S.C. 2201) provides DOE with broad authority to carry out
its responsibilities under the AEA, including the safe management of
facilities authorized by the AEA. This authority is the basis for all
the rules concerning the safe management of nuclear facilities that DOE
intends to adopt in Part 830. The exercise of this authority is not
dependent on whether a civil penalty can be imposed under section 234A
of the AEA (42 U.S.C. 2282a) if the rule is violated after its
adoption. As discussed in the preamble to the final rule on part 820
published on August 17, 1993 (58 FR 43680), DOE has determined that
Part 830 contains the type of requirements relating to nuclear safety
that Section 234A contemplated would form a basis for civil penalties
if violated.
2. Several of the comments stated that the proposed rules would
impose excessive costs on DOE contractors.
Response: DOE does not agree with these statements. For the most
part, part 830 will codify requirements in existing DOE Orders with
which DOE contractors already are obligated contractually to comply.
Accordingly, adoption of the proposed rules should impose little or no
additional costs on contractors. In order to confirm this premise, the
December Notice requested contractors to ``address the specific nature
and scope of [any] additional costs to which contractors would be
subjected and explain why these concerns are not already addressed.''
None of the comments identified any specific additional costs. Finally,
DOE believes that the imposition of requirements through rules will add
predictability and stability to the DOE complex and, therefore, result
in potentially lower operating costs to contractors.
B. General Provisions
1. Several comments addressed proposed Sec. 830.1 (Scope). In
general, these comments questioned what facilities would be subject to
part 830. One comment suggested that a list of the facilities covered
by part 830 should be agreed upon between Management and Operating
(M&O) contractors and DOE to prevent confusion and unnecessary
expenditures of limited resources.
Response: Part 830 applies to all ``nuclear facilities.'' DOE
believes that the definition in Sec. 830.3 is sufficient to determine
the applicability of part 830 to any particular facility. If there is
uncertainty concerning a particular facility, then an interpretation
may be requested under part 820.
2. Several comments suggested alternative wording relative to the
Nuclear Explosives and Weapons Safety Programs exclusion in proposed
Sec. 830.2.
Response: DOE does not find the suggested alternatives more clear.
This exclusion, as worded, applies to activities related to the
prevention of accidental or unauthorized detonation of nuclear weapon
devices.
3. Many of the comments addressed one or more of the definitions in
proposed Sec. 830.3.
Response: DOE is responding to the substantive comments on those
definitions that are being adopted in this final rule. DOE will respond
to the comments on other definitions when they are adopted in
connection with the substantive sections to which they apply.
4. One comment suggested that in order to make the definition of
``contractor'' more complete, the phrase ``laboratory or program'' be
added at the end of the definition after the term ``nuclear facility.''
Response: Part 830 is limited to activities at DOE nuclear
facilities. Since ``nuclear facility'' is a defined term that does not
contain all DOE laboratories or programs, the addition of ``laboratory
or program'' could create ambiguity concerning the Scope of Part 830.
5. One comment suggested that the definition of fissionable
material was not broad enough and suggested that mixtures of nuclides,
such as enriched uranium, be included in the definition.
Response: DOE disagrees with this comment because the proposed
definition includes mixtures of nuclides as long as the mixture
includes one or more of the nuclides which can sustain a neutron-
induced fission chain reaction.
6. A number of comments were received stating that the definition
of ``graded approach'' was too vague, and additional guidance on its
application is necessary. A comment was received that relative risk
should be a mandatory consideration for a graded approach.
Response: The definition of the term ``graded approach'' was
developed to describe the process and factors used to determine which
actions would be appropriate for a particular facility. DOE believes
that this process should be sufficiently broad and flexible to take
into account differences among various facilities. The intent of the
graded approach is to permit DOE contractors the flexibility to
implement activities and processes, as appropriate, to comply with the
nuclear safety requirements for the individual facilities. The graded
approach does not exempt a facility from a nuclear safety requirement.
In applying a graded approach, however, a determination may be made
that certain actions may not be appropriate for a particular facility.
With respect to consideration of risk, this could be considered under
factor six, ``any other pertinent factors.''
7. Several comments stated that the definition of ``hazard'' was
too general. It was felt that the definition should be expanded to
provide a quantitative statement to establish a threshold for when a
situation posed a hazard.
Response: DOE disagrees with this comment. The term ``hazard''
includes all situations with any potential to cause harm to people,
facilities, or the environment. Quantitative considerations are taken
into account in the graded approach when the magnitude of a hazard is
assessed.
8. Several comments stated that the definition of ``hazard'' should
be limited only to potential radiological releases because the Price-
Anderson Amendments Act, which continued and expanded indemnification
for DOE contractors from nuclear accidents and established the civil
penalty program under 234A of the AEA, relates only to nuclear safety
issues.
Response: DOE disagrees with this comment because nonradiological
hazards may have nuclear safety implications. For example,
nonradiological hazardous materials may contribute to the release of or
contamination by radioactivity, such as initiating accidents, or
worsening the consequences of accidents.
9. A number of comments were received stating that the definition
of the term ``nonreactor nuclear facility'' was too vague and that some
threshold relative to source term or some potential dose to the public
or workers (a quantification) should be included in the definition.
Several individuals stated that this quantification must be provided in
the definition to prevent limited resources from being expended on non-
nuclear or low hazard facilities. It was also suggested that the
definition of the term ``nonreactor nuclear facility'' be modified by
deleting the reference to graded approach in the definition.
Response: The Department disagrees with this comment because the
proposed definition was intended to cover all situations (other than
nuclear reactors) with the potential to cause radiological harm. The
reference to the graded approach was included to take into account the
differences that exist between facilities and, thus, to avoid a rigid
application of nuclear safety requirements to divergent facilities and
to encourage the taking of actions appropriate for particular
facilities.
10. Several comments recommended various operations (i.e., research
and development laboratories, environmental restoration, sealed
sources, Uranium Mill Tailings Remedial Action Program) be exempt from
the provisions of these rules. The potential risks associated with each
of these operations was cited as being significantly different than the
risks posed by other nuclear facilities.
Response: DOE has determined that all facilities with which nuclear
materials are associated (except incidently) should be covered by part
830. A facility's improper use of, work with, or handling of nuclear
materials could result in damage or injury caused by nuclear materials
and, thus, are included in this DOE regulatory regime. The use of the
graded approach will permit consideration of differences among
different facilities.
11. Several organizations and individuals inquired if accelerators
were nuclear facilities and, thus, are covered by the DOE nuclear
safety requirements in part 830.
Response: Accelerators are specifically excluded from the
definition of a nonreactor nuclear facility, and, as such, are excluded
from the provisions of part 830. Accelerators are not excluded from the
radiation protection provisions of proposed part 835 since that part
covers nuclear activities rather than nuclear facilities.
12. One comment suggested that transportation and shipping be
included in the definition of a nonreactor nuclear facility because
these operations could involve radioactive materials in sufficient
quantities to have a potential impact on the health and safety of the
public and workers, or damage the environment.
Response: DOE agrees that transportation and shipping could involve
significant quantities of radioactive materials, and did not intend to
cover these activities in the proposed sections of part 830. Therefore,
we have specifically excluded transportation of radioactive materials
from the definition of nonreactor nuclear facility in the final rule.
These activities take place primarily off-site and are governed and
regulated by either the U.S. Department of Transportation or the U.S.
Nuclear Regulatory Commission rules. With regard to shipments on DOE
sites, DOE intends to add provisions covering these operations in
subsequent amendments to the rule.
13. One comment suggested that DOE be included in the definition of
the term ``person.''
Response: The proposed definition is the same as the definition in
the AEA which specifically excludes DOE. DOE believes that the rule
need not be amended to include DOE because DOE imposes equivalent
requirements on its employees through DOE orders.
14. One comment suggested that the definition of ``process'' be
modified to include administrative as well as physical systems.
Response: The definition of ``process'' is intended to include
administrative and physical systems. To make this intent more clear in
the definition, DOE has replaced the term ``system'' with ``series.''
15. One comment suggested that the words ``fails to meet'' be
deleted from the definition of ``quality.'' Another comment suggested
that the phrase ``degree to which'' be replaced by ``condition achieved
when.''
Response: The Department agrees that these two suggested changes
result in a definition of ``quality'' that better reflects the
Department's intent. The modifications have been made.
16. A comment suggested that the definition of reactor was too
broad, and that it be limited to include only the reactor, containment,
and critical support systems. It was suggested that such things as
ancillary support facilities and shops be excluded from the definition.
Response: DOE generally disagrees with this comment. The Department
feels that all of the operations connected with a reactor should be
included in the definition because experience has shown that failures
in ancillary support facilities can propagate and cause failures to
safety related systems. However, specific items can be excluded from
the application of nuclear safety requirements on a case-by-case basis
through the exemption process set forth in 10 CFR part 820.
17. A comment suggested that the ``reactor'' definition developed
by the Nuclear Regulatory Commission (NRC), with which everyone in the
industry is familiar, should be used instead of the one in the proposed
rulemaking.
Response: DOE disagrees with this comment. The NRC definition for
``nuclear reactor'' contained in 10 CFR part 50 addresses standardized
power reactors. The population of DOE reactors is more diverse,
including multiple designs and sizes of reactors all with different
purposes. For these reasons, the Department developed its own
definition for ``reactor.''
18. One comment suggested that the definition for the term
``record'' be expanded to note that it is a document which is completed
according to applicable procedures governing its development, including
any review and approval requirements.
Response: DOE disagrees with this suggestion because the proposed
additions make the definition too limiting. For completeness, DOE has
added the term ``service'' to the definition.
19. It was suggested that the definition of service was incomplete
without the addition of the words ``construction, testing,
environmental qualification, equipment qualification, and `or the
like''' to the definition.
Response: The Department agrees with the comment and has modified
the definition accordingly.
20. One individual expressed concern over the confusion that could
potentially arise from the statement in 10 CFR 830.4 that,
``contractors responsible for design, construction, operations, or
decommissioning of a facility shall be responsible for compliance with
this Part.'' In the potential situation where an M&O contractor
performs construction activities at an existing facility being run by
another M&O contractor, the individual questioned whether one or both
of the contractors would be held accountable for compliance with
nuclear safety requirements.
Response: Section 830.4(a) provides that all persons must act in
accordance with part 830. Enforcement through the assessment of civil
penalties will apply only where there is a nexus between a person's
activity and the violation. For example, a person who designs a
facility will not be responsible for a violation related to the
operation of the facility unless the design was somehow responsible for
the violation.
21. A comment stated that it would be extremely difficult, if not
impossible, to comply with Sec. 830.4(b) which requires facilities
being decommissioned to meet the requirements of this Part.
Response: While facilities in the decommissioning phase will be
required to comply with the provisions of this rule, the level to which
they are applied will be based on a graded approach taking into
consideration the hazards associated with a facility being
decommissioned.
22. Several comments addressed provisions in certain of the
proposed rules which require plans or programs to implement those
rules. These comments stated that more time should be given to prepare
the plans and programs and that they not provide the basis for the
imposition of civil penalties.
Response: In general, plans that provide the schedules and actions
necessary to implement the requirements of specific sections must be
submitted to DOE within 180 days of the effective date of the rule. DOE
has decided this schedule is not unreasonably short, especially since
these plans are intended to identify the specific actions and programs
necessary to fully comply with a section which has a corresponding
Order that is already effective.
DOE believes the expressed concerns relate more to the question of
when a contractor must comply fully with a rule. DOE expects a
contractor to comply with a rule when it becomes effective. DOE
understands that, in many circumstances, a contractor may not be able
to take all actions for full compliance immediately. The proposal was
premised on the use, where appropriate, of plans and programs to obtain
full compliance with nuclear safety requirements. These plans and
programs were envisioned as setting forth the specific actions for
implementing a requirement and the schedule for taking those actions.
DOE has decided to state this premise explicitly in the final rule by
adding a definition of ``implementation plan'' and by specifically
requiring implementation plans in appropriate sections. Implementation
plans will set forth when and how a contractor will take those actions
necessary to attain full compliance with the provisions of a section or
the provisions of a plan or program required by the section.
Implementation plans also will identify where a contractor cannot
attain full compliance with a nuclear safety requirement and what
relief a contractor intends to seek. DOE also has modified Section
830.4 to make clear that, where required, implementation plans, along
with plans and programs, will be the basis for determining compliance
with relevant nuclear safety requirements.
DOE believes the use of plans, programs, and implementation plans
will encourage DOE and its contractors to work together to identify and
take those actions appropriate for each facility. DOE expects its
contractors will submit plans and programs that represent a good faith
effort to achieve full compliance with nuclear safety requirements as
soon as reasonably practicable. DOE intends to work with its
contractors where there are differences about how and when to achieve
compliance. However, DOE will act to ensure that plans and programs are
submitted and approved pursuant to the schedules set forth in specific
sections. To that end, if agreement cannot be negotiated with a
contractor, DOE will exercise its authority to modify submitted plans
that do not include those actions and schedules appropriate for
achieving full compliance in a reasonable manner. The nature of plans
is discussed more thoroughly in the preamble to the final rule on Part
820.
23. There were many comments related to the enforcement (Section
830.5) of part 830 using the provisions of 10 CFR part 820.
Response: The responses to these comments were included in the
publication package of 10 CFR part 820. The general provisions in this
subpart are unaffected by those comments relating to the specifics of
enforcement.
24. One commenter suggested that 10 CFR 830.7(a) be revised to read
as follows: ``A graded approach shall be utilized to comply with the
requirements.'' The individual felt that the intent of the rule is to
apply a graded approach across the board to all nuclear safety
requirements.
Response: The Department has not adopted this comment with respect
to reactors generally because there are some areas in reactor safety
where a graded approach is not justified; therefore, grading applies
only to those subparts where it is specifically referenced. The
definition of nonreactor nuclear facility indicates that grading always
applies to such a facility.
25. A number of comments were received which stated that the burden
of justifying the use of the graded approach to meet each of the
nuclear safety requirements will require considerable resources.
Response: The intent of paragraph 830.7(b) is that contractors
document the basis for the actions selected pursuant to the graded
approach, where it is permitted. Paragraph 830.7(b) has been modified
to state this intent. Implementation of requirements using a documented
graded approach will require less resources than an approach which
requires full compliance with all requirements.
C. Quality Assurance Requirements Section 830.120
Quality Assurance Program (QAP) Submittals
1. There were several comments relating to the scope of QAP
submittals and the need for multiple QAPs at one facility.
Response: Regarding the scope of QAP submittals, DOE agrees that
they should be limited to a ``description'' of the QAP. It is not the
Department's intent that submittals of the QAP include contractor
policy manuals, organization charts and charters, and implementing
procedures. The definition of ``Quality Assurance Program'' in
Sec. 830.3 makes this clear when it states that the ``QAP means the
overall program for a DOE nuclear facility which assigns
responsibilities and authorities, defines policies and requirements,
and provides for the performance and assessment of work.''
Regarding multiple QAPs for one facility, the Department believes
that there may be cases where some facilities will require separate
QAPs to address their widely different work. However, the Department
also believes that it is possible in many instances to develop and
implement a site-wide QAP where multiple facilities exist.
2. There were several comments regarding the approval of QAPs. The
first dealt with the concept of automatically approving QAPs after 90
days.
Response: This concept is not new. The NRC has successfully
implemented a similar program for the past 10 years. The intent of the
90-day limitation (unless approved or rejected by DOE prior to that
time) is to avoid situations where contractors are left without a
decision regarding their QAPs' acceptability because DOE exigencies
preclude timely review. It is the Department's expectation that DOE
will review QAPs within the allotted time. If for some reason the
review cannot be accomplished in the allotted time, the program will be
approved and in effect, subject to DOE's right to modify the program at
a later time. Implementation plans will be approved in the same manner
as QAPs. (See response to Question 22 in previous section.)
3. Another comment suggested that annual approval of changes to
QAPs was too infrequent.
Response: Experience at the NRC has shown that changes to QAPs do
not manifest themselves at the working level so quickly as to require
formal submittal and review more often than once per year. If an
interim change to a QAP violates nuclear safety requirements, the
contractor is subject to enforcement action if the violation has safety
significance since a QAP must be consistent with the criteria set forth
in Sec. 830.120.
4. Another comment dealt with the level of approval. The comment
suggested that the rule specify the precise level of DOE approval for
QAPs. Specifically, it was suggested that the Program Secretarial
Officer be designated.
Response: The Department does not agree that the titles of those
persons or organizations responsible for approving QAPs should appear
in the rule because of the potential administrative burden it would
cause. Specific titles, such as ``Program Secretarial Officer,'' are
subject to routine changes, and these changes would necessitate routine
revisions to the rule if the titles were included in the text of the
rule. The specific level of approval for QAPs should be specified in
the operating procedures of the individual program offices tasked with
that responsibility.
5. Lastly, one comment suggested that the rule be revised to state
that the contractor's approved QAP be used as the basis against which
assessments would be conducted and the contractor held accountable.
Response: As discussed previously, Sec. 830.4(c) makes clear that
the QAP and the implementation plan for Sec. 830.120 will be used to
determine compliance with Sec. 830.120.
Applicability
6. Two comments noted the apparent overlap of Sec. 830.120 and DOE
Order 5700.6C, ``Quality Assurance.''
Response: Section 830.120 is intended to supersede the existing
requirements in DOE 5700.6C, ``Quality Assurance,'' for nuclear
facilities. If any quality assurance program is implemented on a site-
wide basis, non-nuclear facilities at that site will continue to be
covered by the DOE Order while nuclear facilities will be covered by
Sec. 830.120. DOE 5700.6C is being revised to reflect these changes in
scope.
Grading
7. Four comments addressed the need to consider nuclear safety
significance in determining the rigor with which the requirements of
the rule are applied. Several other comments expressed concern that
applying the rule, without distinguishing between the relative
importance of the work to which it applies, was impracticable. In
addition, there were two comments regarding the rule's use of the term
risk. Both comments proposed that the term ``hazard'' was more
appropriate and better reflected the concept of grading.
Response: The Department agrees that the use of the term ``risk''
was inappropriate, but rather than using the term ``hazard,'' a new
sentence regarding grading was added to paragraph (b)(1).
Standards
8. There were three comments relating to standards. One comment
expressed the need for a uniform set of quality assurance guidelines
and standards for use by the Department.
Response: The Department agrees that there is a need for a uniform
set of standards for all activities, including quality assurance. The
Department strongly supports the development of standards and
guidelines. Accordingly, DOE will develop and issue quality assurance
standards and guidance to support promulgation of QAPs.
9. Two comments suggested that the rule's ``generalized'' reference
to the use of standards was not sufficient to ensure acceptable work.
Response: The rule in paragraph (b)(1) of Sec. 830.120 provides for
the use of standards to develop and implement QAPs. Because there are
numerous quality assurance standards and they are continuously
changing, it would be unnecessarily limiting to mandate in the rule a
particular standard or set of standards that must be used by
contractors. Any number of standards can be proposed, justified, and
approved.
DOE 5700.6C
10. There was one comment addressing a perceived reduction in
quality assurance requirements. The comment stated that the rule ``has
reduced the level of requirements for the application of material
control, process control and calibration control from the level of
requirements specified in DOE Order 5700.6C.'' The comment further
stated that ``the rule fails to adequately address the following 10 CFR
part 50, appendix B, requirements: Calibration of measuring and test
equipment, special process controls, control of design input and design
analysis, procurement planning and selection of suppliers,
qualification of inspection and test personnel, inspection planning and
in-process inspection, test records and procedure content,
identification and control of inspection or test status,
identification, retrieval and retention of records.''
Response: First, the Department disagrees that the rule has
``reduced the level of requirements for the application of material
control, process control, and calibration control from the level of
requirement[s] specified in DOE Order 5700.6C.'' The basic requirements
of DOE 5700.6C and Sec. 830.120 are identical; therefore, there can be
no reduction in requirements. Secondly, regarding the rule's purported
failure to address certain requirements from 10 CFR part 50, appendix
B, they are addressed in the following sections of Sec. 830.120: (1)
Calibration of measuring and test equipment--paragraph (c)(2)(iv), (2)
special process controls--paragraphs (c)(2) (i) and (iv), (3) control
of design input and design analysis--paragraph (c)(2)(ii), (4)
procurement planning and selection of suppliers--paragraph (c)(2)(iii),
(5) qualification of inspection and test personnel--paragraph
(c)(1)(ii), (6) inspection planning and in-process inspection--
paragraph (c)(2)(iv), (7) test records and procedure content--paragraph
(c)(1)(iv), (8) identification and control of inspection or test
status--paragraph (c)(2)(iv), and (9) identification, retrieval, and
storage of records--paragraph (c)(1)(iv).
Program (Criterion 1)
11. There were three comments regarding the inclusion of planning,
schedule, and cost-control as part of the quality assurance program.
All three organizations asserted that planning, scheduling, and cost-
control were not directly pertinent to nuclear safety and, therefore,
should not be addressed in the rule.
Response: The inclusion of these considerations is a departure from
the traditional approach to quality assurance. DOE disagrees that they
are not directly pertinent to nuclear safety. Because the quality
assurance program described by the rule is a management system
involving all organizational components, including management and the
line organization, these considerations must be taken into account.
Contemporary practice has shown that quality, costs, schedule,
resources, and planning are inseparable and integral parts of the
quality system and cannot be separated as they have been in the past.
Personnel Training and Qualification (Criterion 2)
12. There were two comments regarding perceived conflicts between
Parts 830.120, ``Quality Assurance Requirements,'' 830.330, ``Training
and Certification,'' and 830.110, ``Safety Analysis Reports'' (SARs).
Response: DOE disagrees that there is a conflict between the
requirements of Secs. 830.120, 830.330, and 830.110. Section 830.120,
``Quality Assurance Requirements,'' provides generic training and
qualification requirements that pertain to all contractor personnel
performing work at a DOE facility. Section 830.330, ``Training and
Certification,'' elaborates on these generic requirements by providing
specific training and certification requirements for specific
categories of employees, such as reactor operators, nuclear facility
operators, senior reactor operators, and nuclear facility supervisors.
Section 830.110, ``Safety Analysis Reports,'' sets forth the topic
areas, including training, to be addressed in each facility's SAR. The
details of training to be included in the SAR will be based on the
generic requirements of Section 830.120 and the specific requirements
of Section 830.330.
Quality Improvement (Criterion 3)
13. There were seven comments regarding quality improvement. Five
of the comments dealt with the concern that quality improvement could
not be ``ensured'' as was required by Criterion 3 of the rule.
Response: The Department agrees and has modified paragraph
(c)(1)(iii).
14. Two comments suggested that the term ``significant'' be
introduced into Criterion 3 when referring to the types of problems
that require corrective action.
Response: It is the Department's position that the causes of all
problems (not just those considered significant or generic) should be
identified and corrected. In doing this, the rigor with which a problem
is investigated and corrective action taken should be commensurate with
the importance of the problem and the work affected (graded approach).
Documents and Records (Criterion 4)
15. There was one comment regarding paragraph (c)(1)(iv). The
comment stated that the rule ``makes no provision for the
identification, retrieval, or retention of records as required by 10
CFR part 50, appendix B.'' The comment maintained that the rule would
``appear to be a step backward in the protection of records, yet the
draft safety guide invokes DOE 1324.2A and mandates National Archives
and Records Administration rules as applicable to nuclear facilities.
This contradicts the purpose of the rulemaking process which would
replace Orders with rules.''
Response: As written, the rule requires that records be specified,
prepared, reviewed, approved, and maintained. While this terminology is
different than that used in 10 CFR part 50, appendix B, it does
encompass the concepts of record ``identification, retrieval, [and]
retention'' as stated in appendix B. Secondly, safety guides do not
invoke or mandate requirements. DOE safety guides provide DOE
contractors with acceptable methods for implementing specific parts of
the Department's rules. Safety guides are not substitutes for rules,
and while they must be considered by contractors, methods and solutions
different from those set out in the guides are acceptable if the
requirements of the rule are met.
Work Processes (Criterion 5)
16. A comment stated that Criterion 5 did not clearly distinguish
between the relative importance of the items and processes to which it
applied.
Response: The Department agrees and has modified paragraph (b)(1)
to require application of a graded approach to all criteria.
17. A second comment questioned the relationship between the
requirements of paragraph (c)(2)(i) of Sec. 830.120, ``Quality
Assurance Requirements,'' and Section 830.310, ``Conduct of
Operations,'' relating to procedures.
Response: Criterion 5 addresses ``Work Processes.'' The Department
considers operations to be a work process. Criterion 5 goes further to
require that work (like the operations process) be performed using
approved instructions, procedures, or other appropriate means.
Operations procedures, the term used in Sec. 830.310, describe how work
is to be accomplished during the operation of DOE facilities.
Operations procedures are one type--a subset--of procedures required by
Criterion 5 (maintenance procedures are another).
18. A comment stated that the handling, storage, and shipping of
environmental samples as required by the Washington State Tri-Party
Agreement and Environment Protection Agency (EPA) guidelines was not
addressed by the rule in Criterion 5.
Response: The Department disagrees. The rule establishes basic
quality assurance requirements applicable to the many and diverse types
of work performed by and for the Department. Criterion 5 (paragraph
(c)(2)(i)) requires that ``Items be identified and controlled to ensure
their proper use.'' The definition of ``item'' provided by the rule
encompasses environmental samples.
19. One comment also stated that the rule did not provide
requirements for item identification and traceability.
Response: As stated in the previous paragraph, Criterion 5 requires
that ``Items be identified and controlled to ensure their proper use.''
``Traceability'' is one way to ensure that items are ``controlled'' as
required by the rule. For that reason, the rule does not specifically
address traceability.
20. Additionally, a comment stated that Criterion 5 of the rule did
not address ``special processes'' as does the NRC's 10 CFR part 50,
appendix B.
Response: In developing the rule, the Department found that work,
such as welding and non-destructive testing, have traditionally been
referred to by the commercial nuclear industry as ``special processes''
because of the way their acceptability was determined (in-process). The
rule, because it is not inspection-driven like 10 CFR part 50, appendix
B, does not distinguish between different types of work based on
whether or not it can be ``readily inspected.'' How the acceptability
of a work process is determined does not make a work process
``special.'' Rather, the rule, in Criterion 5 (paragraph (c)(2)(i))
focuses on the line organization's performance of work. Inspection and
acceptance testing of all types of work, both ``regular'' and
``special,'' is addressed by the rule in paragraph (c)(2)(iv),
``Inspection and Acceptance Testing.''
Design (Criterion 6)
21. A comment stated that Criterion 6 ``does not address the design
of sampling and analysis procedures but appears to be limited to design
of engineered structures.''
Response: The requirements of Section 830.120 are not limited to
the design of engineered structures. Paragraph (c)(2)(i) of the rule
requires that ``work (which includes those suggested in the comment) be
performed to established technical standards and administrative
controls'' and that ``work shall be performed under controlled
conditions using approved instructions, procedures, or other
appropriate means.''
22. One comment stated that ``the failure of the rule to define or
reference the EPA requirements for site investigation and remedial
action activities will result in non-standard, site-specific
applications.''
Response: In the context of this section, the Department feels that
the existing language in the section is sufficient so that it is
unnecessary to define or reference EPA requirements.
Procurement (Criterion 7)
23. One comment stated that the rule made no provisions for
commercial grade procurement and, as a result, there would be a
``significant cost increase for DOE nonreactor nuclear facilities who
will be required by the rule to limit the selection of suppliers to
those that have quality assurance programs in accordance with the
rule.''
Response: The Department disagrees. As written, paragraph
(c)(2)(iii) of the section requires that all procured items (commercial
grade items are one type of procured item) meet established
requirements and perform as expected. Nowhere in the section does it
require that procurement be limited only to suppliers ``that have
quality assurance programs.'' To the contrary, the section requires
that procured items ``meet established requirements and perform as
expected.'' The way in which requirements are met should be specified
in the contractor's QAP taking into account the relative importance of
the item or service being procured (graded approach).
Inspection and Acceptance Testing (Criterion 8)
24. There were three comments relating to different aspects of
Criterion 8. The first comment concerned the rule's perceived failure
to provide for in-process inspection or test, particularly with regard
to site characteristic testing for remediation work.
Response: As written, the rule in paragraph (c)(2)(iv) requires
that inspection and acceptance testing of specified items and processes
(this includes testing of site characteristics) be conducted using
established acceptance and performance criteria. In-process inspection
and testing is not specifically called out in the rule because it is
one of many techniques for conducting inspections and tests.
25. The second comment dealt with test status. The comment stated
that the rule provides no definition of requirements for the
identification and control of inspection or test status as required by
10 CFR part 50, appendix B.
Response: The Department disagrees. As written, paragraph
(c)(2)(iv) of the section establishes a basic requirement that
inspections and acceptance testing be performed. In practice, one
aspect of properly performing the work of inspecting and testing is to
ensure that the status of the item be known, such that the inspection
or test is properly completed and the item is not relied on to perform
this intended function. It is inappropriate to include this level of
detail in a rule whose intention it is to establish basic quality
assurance requirements applicable to all DOE facilities.
26. The third comment dealt with the calibration of instruments and
the perception that the rule only addresses the calibration of process
monitoring instrumentation and data collection equipment. The comment
maintained that the rule does not address requirements for calibration
interval, accuracy, and stability in process monitoring instrumentation
or equipment used to collect environmental data.
Response: In actuality, the rule, as written, addresses both the
calibration and maintenance of equipment used for inspection and
acceptance testing (paragraph (c)(2)(iv)) and the calibration and
maintenance of equipment used for monitoring and data collection
(paragraph (c)(2)(i)). It is the Department's position that the phrase
``calibration and maintenance'' encompasses the ``requirements for
calibration interval, accuracy, [and] stability.''
Management Assessment (Criterion 9)
27. There were three comments regarding the requirements of
Criterion 9. One comment noted that the requirement to conduct periodic
assessments of integrated performance at ``all'' levels of management
is too restrictive and unnecessary.
Response: The Department agrees and has revised paragraph (c)(3)(i)
accordingly.
28. A second comment requested clarification of Criterion 9
regarding who in management was required to perform the assessments.
The comment asserted that individual managers have the responsibility
and authority ``to assess the QA program'' within their cognizant
areas.
Response: DOE agrees. Criterion 9 recognizes this and requires that
these individual inputs be gathered and combined by upper level
managers into an overall assessment of the integrated management
system. This management assessment should seek common weaknesses and
areas needing improvement.
29. The third comment states that Sec. 830.120 ``contradicts the
requirements of Sec. 830.310 which requires that the conduct of
operations program and its effectiveness on facility operations will be
assessed through management observation and audit.''
Response: The Department sees no conflict between the requirements
of Sec. 830.120 paragraph (c)(3)(i) and Sec. 830.310 paragraph (g)
because the two are unrelated. Paragraph (c)(3)(i) of Sec. 830.120
addresses ``management assessment,'' while paragraph (g) of
Sec. 830.310 addresses the ``independent assessment'' component of
Sec. 830.120 which is in paragraph (c)(3)(ii). To make this distinction
more clear, paragraph (g) of Sec. 830.310 will be revised to reflect
the language from Sec. 830.120.
NQA-1
30. One individual observed that DOE had previously ``imposed''
ASME/NQA-1 for all of its sites and that the Department would be better
served by continuing its use.
Response: Neither DOE 5700.6C nor its predecessor, 5700.6B,
``imposed'' NQA-1. DOE 5700.6B referred to NQA-1 as a ``preferred''
standard and 5700.6C referenced it for general information only. In
practice, NQA-1 is a national consensus standard. It interprets the
requirements of the NRC's 10 CFR part 50, appendix B and provides
guidance for developing and implementing quality assurance programs at
specific types of nuclear facilities.
The rule does not prohibit the use of NQA-1 at the Department's
nuclear facilities. Just as the NRC has endorsed NQA-1 as an acceptable
way (there are others) for their licensees to implement the
requirements of appendix B, DOE contractors may use NQA-1 as a way to
implement the rule. In addition, DOE (like the NRC) will permit
contractors (NRC licensees) to use other industry standards as long as
their applications result in acceptable product and service quality.
31. One comment stated that the rule did not provide ``even a
minimum level of requirements for software quality as required by
existing DOE Orders and NRC NUREG-1200.'' The comment asserted that the
absence of software quality assurance requirements was a significant
shortcoming in the rule.
Response: The rule in paragraph (a)(1)(i) requires that a
contractor conduct its work in accordance with the criteria of
paragraph (c). Because DOE considers software to be a type of work, it
follows that all the quality assurance requirements of the rule apply
to software.
Suppliers/Subcontractors
32. Two organizations commented that the intent of paragraph (a)(2)
was not clear and that methods to implement its requirements were not
provided by the rule. Additionally, a general comment was submitted
exploring whether or not subcontractors and suppliers performing
services for DOE are required under the provision of the rule to
develop and submit a QAP.
Response: Paragraph (a)(2), which required that subcontractors and
suppliers comply with the ``standards of quality set forth in the
QAP,'' has been deleted. After review, the Department determined that
paragraph (c)(2)(iii) of the rule adequately addresses this issue by
establishing basic requirements for procurement. It states that items
and services (this includes items and services procured from
subcontractors and suppliers) must meet established requirements and
perform as expected. Subcontractors and suppliers are not required to
submit to DOE their QAPs for review and approval; rather, it is left to
the contractor to determine the methods for ensuring that procured
items and services meet requirements and perform as expected. Any
person, including indemnified contractors and their subcontractors and
suppliers, subject to requirements in a QAP, may be subject to
enforcement actions under part 820 if those requirements are violated.
III. Final Rule
After considering the public comments, DOE has decided to adopt 10
CFR 830.1 through 830.7, 830.100, and 830.120 with the modifications
described in the previous section and several editorial changes. A
section by section description of the final rule follows.
Section 830.1 mandates that the scope of part 830 is all DOE
nuclear facilities.
Section 830.2 stipulates that the activities excluded from the
provisions of part 830 include activities regulated by the Nuclear
Regulatory Commission (NRC) or NRC Agreement States, activities
conducted by the Naval Nuclear Propulsion Program, and activities
conducted under the Nuclear Explosives and Weapons Safety Program. The
final rule has been modified to make clear that the exclusion applies
to activities of the United States Enrichment Corporation to the extent
that those activities have been certified by the NRC.
Section 830.3 provides the definitions of terms related to
Secs. 830.1 through 830.7, 830.100, and 830.120. New definitions for
``DOE nuclear facilities'' and ``implementation plans'' have been
included to remove any ambiguity concerning the meaning of these terms.
Section 830.4, General Rule, indicates that no person shall prevent
compliance with the provisions of the rule. In addition, it requires
that contractors responsible for managing and operating the
Department's nuclear facilities shall be responsible for implementing
and complying with the provisions of part 830. Paragraph (c) has been
included to make clear that contractors must comply with any plans,
programs, or implementation plans required by a section and that, where
required, they are intended to be the means by which compliance is
determined. In particular, implementation plans will be used to set
forth the manner in which full compliance with specific requirements
will be attained.
Section 830.5 provides that part 830 shall be enforced according to
the provisions of 10 CFR part 820, published in the Federal Register on
August 17, 1993 (58 FR 43680).
Section 830.6 requires that records be maintained such that
compliance with the provisions of part 830 can be substantiated.
Section 830.7 mandates the use of a graded approach when so
indicated in a subpart. It also requires the documentation of the
reasons for the selection of specific actions to be taken pursuant to
the graded approach.
Section 830.100, Scope of subpart, provides a statement of general
applicability for Subpart A of part 830.
The ``Quality Assurance Requirements'' section, 830.120, mandates
the development and implementation of a formalized quality assurance
program. To ensure full compliance, DOE will review and approve
contractor-proposed quality assurance programs and will evaluate
contractor performance against the approved program including any
modifications made or directed by DOE. Because of the clarification
concerning implementation plans, DOE has decided to delete the proposed
distinction between new and existing facilities. However, DOE does not
expect to authorize the operation of any new facility unless a quality
assurance program is approved and full compliance with Sec. 830.120 is
assured.
IV. Procedural Requirements
A. Review Under Executive Order 12866
Today's regulatory action has been determined to be a ``significant
regulatory action'' under Executive Order 12866, ``Regulatory Planning
and Review,'' (58 FR 51735, October 4, 1993). Accordingly, today's
action was subject to review under the Executive Order by the Office of
Information and Regulatory Affairs (OIRA). There were no substantive
changes between the draft submitted to OIRA and today's action.
The draft of today's action and any other documents submitted to
OIRA for review have been made a part of the rulemaking record and are
available for public review in the Department's Freedom of Information
Reading Room, 1000 Independence Avenue, SW., Washington, DC 20585
between the hours of 9 and 4, Monday through Friday, telephone (202)
586-6020.
B. Review Under the Regulatory Flexibility Act
This rule was reviewed under the Regulatory Flexibility Act of
1980, Public Law 96-354, which requires preparation of a regulatory
flexibility analysis for any rule that is likely to have significant
economic impact on a substantial number of small entities. DOE
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities; therefore, no
regulatory flexibility analysis has been prepared.
C. Review Under the Paperwork Reduction Act
No new information collection or record keeping requirements are
imposed by this final rule. Information collection provisions of this
rule were previously approved under OMB Control No. 1910-0300.
Accordingly, no Office of Management and Budget clearance is required
by the Paperwork Reduction Act of 1990 (44 U.S.C. 3501 et seq.) and the
procedures implementing that Act, 5 CFR 13230.1 et seq.
D. Review Under the National Environmental Policy Act
The DOE has concluded that promulgation of this rule would not
represent a major Federal action having significant impact on the human
environment under the National Environmental Policy Act (NEPA) of 1959
[42 U.S.C. et seq. (1976)], or the Council of Environmental Quality
regulations (40 CFR parts 1500-1508) and DOE guidelines (10 CFR part
1021), and, therefore, does not require an environmental impact
statement or an environmental assessment pursuant to NEPA.
E. Review Under Executive Order 12612
Executive Order 12612, 52 FR 41685 (October 30, 1987) requires that
regulations, rules, legislation, and any other policy actions be
reviewed for any substantial direct effects on States, on the
relationship between the National Government and the States, or in the
distribution of power and responsibilities among various levels of
Government. If there are sufficient substantial direct effects on
States, on the relationship between the National Government and the
States, or in the distribution of power and responsibilities among
various levels of Government, the Executive Order requires preparation
of a federalism assessment to be used in all decisions involved in
promulgating and implementing a policy action. This final rule will not
have a substantial direct effect on the institutional interests or
traditional functions of States.
F. Review Under Executive Order 12778
Section 2 of Executive Order 12778 instructs each agency to adhere
to certain requirements in promulgating new regulations and reviewing
existing regulations. These requirements, set forth in sections 2(a)
and (b)(2), include eliminating drafting errors and needless ambiguity,
drafting the regulations to minimize litigation, providing clear and
certain legal standards for affected conduct, and promoting
simplification and burden reduction. Agencies are also instructed to
make every reasonable effort to ensure that the regulation specifies
clearly any preemptive effect, effect on existing Federal law or
regulation, and retroactive effect; describes any administrative
proceedings to be available prior to judicial review and any provisions
for the exhaustion of such administrative proceedings; and defines key
terms. The DOE certifies that today's rule meets the requirements of
sections 2(a) and (b)(2) of Executive Order 12778.
List of Subjects in 10 CFR Part 830
Federal buildings and facilities, Nuclear energy, Nuclear material,
Nuclear reactors, Reporting and record keeping requirements, and
Safety.
Issued in Washington, DC, on 29 March 1994.
Tara O'Toole,
Assistant Secretary, Environment, Safety and Health.
For the reasons set forth in the preamble, Title 10, Chapter III,
of the Code of Federal Regulations is amended by adding a new part 830
as follows:
PART 830--NUCLEAR SAFETY MANAGEMENT
Sec.
830.1 Scope.
830.2 Exclusions.
830.3 Definitions.
830.4 General rule.
830.5 Enforcement.
830.6 Records.
830.7 Graded approach.
Subpart A--General Provisions
Sec.
830.100 Scope of subpart.
830.120 Quality assurance requirements.
Subpart B--Design [Reserved]
Subpart C--Operations [Reserved]
Subpart D--Material Management [Reserved]
Authority: 42 U.S.C. 2201; and 7191.
Sec. 830.1 Scope.
This part governs the conduct of the Department of Energy (DOE)
management and operating contractors and other persons at DOE nuclear
facilities.
Sec. 830.2 Exclusions.
This part does not apply to:
(a) Activities that are regulated through a license by the Nuclear
Regulatory Commission (NRC) or a State under an Agreement with the NRC,
including activities certified by the NRC under section 1701 of the
Atomic Energy Act;
(b) Activities conducted under the authority of the Director, Naval
Nuclear Propulsion Program, as described in Public Law 98-525; or
(c) Activities conducted under the Nuclear Explosives and Weapons
Safety Program relating to the prevention of accidental or unauthorized
nuclear detonations.
Sec. 830.3 Definitions.
(a) The following definitions apply to this Part:
Administrative Controls mean provisions relating to organization
and management, procedures, record keeping, assessment, and reporting
necessary to ensure safe operation of a facility.
Contractor means any person under contract with the Department of
Energy with responsibility to perform activities in connection with a
nuclear facility.
Department or DOE means the Department of Energy.
Document means recorded information that describes, specifies,
reports, certifies, requires, or provides data or results. A document
is not considered a record until it meets the definition of record.
Fissionable materials means a nuclide capable of sustaining a
neutron-induced fission chain reaction (e.g., uranium-233, uranium-235,
plutonium-238, plutonium-239, plutonium-241, neptunium-237, americium-
241, and curium-244).
Graded Approach means a process by which the level of analysis,
documentation, and actions necessary to comply with a requirement in
this Part are commensurate with:
(1) The relative importance to safety, safeguards, and security;
(2) The magnitude of any hazard involved;
(3) The life cycle stage of a facility;
(4) The programmatic mission of a facility;
(5) The particular characteristics of a facility; and
(6) Any other relevant factor.
Hazard means a source of danger (i.e., material, energy source, or
operation) with the potential to cause illness, injury, or death to
personnel or damage to a facility or to the environment (without regard
to the likelihood or credibility of accident scenarios or consequence
mitigation).
Implementation Plan means a document prepared by a contractor that
sets forth:
(1) When and how the actions appropriate to comply with the
requirements of a section of this Part, including the requirements of a
plan or program required by the section, shall be taken, and
(2) What relief will be sought if a contractor cannot attain full
compliance with a requirement in a reasonable manner.
Item is an all-inclusive term used in place of any of the
following: appurtenance, assembly, component, equipment, material,
module, part, structure, subassembly, subsystem, system, unit, or
support systems.
Nonreactor nuclear facility means those activities or operations
that involve radioactive and/or fissionable materials in such form and
quantity that a nuclear hazard potentially exists to the employees or
the general public. Incidental use and generating of radioactive
materials in a facility operation (e.g., check and calibration sources,
use of radioactive sources in research and experimental and analytical
laboratory activities, electron microscopes, and X-ray machines) would
not ordinarily require the facility to be included in this definition.
Transportation of radioactive materials, accelerators and reactors and
their operations are not included. The application of any rule to a
nonreactor nuclear facility shall be applied using a graded approach.
Included are activities or operations that:
(1) Produce, process, or store radioactive liquid or solid waste,
fissionable materials, or tritium;
(2) Conduct separations operations;
(3) Conduct irradiated materials inspection, fuel fabrication,
decontamination, or recovery operations;
(4) Conduct fuel enrichment operations;
(5) Perform environmental remediation or waste management
activities involving radioactive materials; or
(6) Design, manufacture, or assemble items for use with radioactive
materials and/or fissionable materials in such form or quantity that a
nuclear hazard potentially exists.
Nuclear facility means reactor and nonreactor nuclear facilities.
Person means any individual, corporation, partnership, firm,
association, trust, estate, public or private institution, group,
Government agency, any State or political subdivision of, or any
political entity within a State, any foreign government or nation or
other entity and any legal successor, representative, agent or agency
of the foregoing; provided that person does not include the Department
or the United States NRC.
Process means a series of actions that achieves an end or result.
Quality means the condition achieved when an item, service, or
process meets or exceeds the user's requirements and expectations.
Quality Assurance means all those actions that provide confidence
that quality is achieved.
Quality Assurance Program or QAP means the overall program
established to assign responsibilities and authorities, define policies
and requirements, and provide for the performance and assessment of
work.
Reactor means, unless it is modified by words such as containment,
vessel, or core, the entire nuclear reactor facility, including the
housing, equipment, and associated areas devoted to the operation and
maintenance of one or more reactor cores. Any apparatus that is
designed or used to sustain nuclear chain reactions in a controlled
manner, including critical and pulsed assemblies and research, test,
and power reactors, is defined as a reactor. All assemblies designed to
perform subcritical experiments that could potentially reach
criticality are also to be considered reactors. Critical assemblies are
special nuclear devices designed and used to sustain nuclear reactions.
Critical assemblies may be subject to frequent core and lattice
configuration change and may be used frequently as mockups of reactor
configurations.
Record means a completed document or other media that provides
objective evidence of an item, service, or process.
Service means the performance of work, such as design,
construction, fabrication, inspection, nondestructive examination/
testing, environmental qualification, equipment qualification, repair,
installation, or the like.
(b) Terms defined in the Act and not defined in these rules are
used consistent with the meanings given in the Act.
(c) As used in this Part, words in the singular also include the
plural and words in the masculine gender also include the feminine and
vice versa, as the case may require.
Sec. 830.4 General rule.
(a) No person shall take or cause to be taken any action
inconsistent with the requirements of this Part or any program, plan,
schedule, or other process established by this Part.
(b) With respect to a particular DOE nuclear facility, the
contractor responsible for the design, construction, operation, or
decommissioning of that facility shall be responsible for
implementation of, and compliance with, the requirements of this Part.
(c) When a section of this Part expressly requires a plan, program,
or implementation plan, the provisions of any such plan, program, or
implementation plan, as approved by DOE, shall be the basis used to
determine compliance with the relevant nuclear safety requirements in
the section.
Sec. 830.5 Enforcement.
The requirements in this Part are DOE Nuclear Safety Requirements
and are subject to enforcement by all appropriate means, including the
imposition of civil and criminal penalties in accordance with the
provisions of Part 820 of this title.
Sec. 830.6 Records.
A person shall maintain complete and accurate records as necessary
to substantiate its compliance with the requirements of this Part.
Sec. 830.7 Graded approach.
(a) Where indicated in a subpart, a graded approach shall be
utilized to comply with the requirements.
(b) Whenever a graded approach is applied in meeting a DOE nuclear
safety requirement, the bases for selecting an action pursuant to the
graded approach shall be documented.
Subpart A--General Provisions
Sec. 830.100 Scope of subpart.
This subpart prescribes requirements that are generally applicable
to more than one phase of the life cycle of a DOE nuclear facility.
Sec. 830.120 Quality assurance requirements.
(a) General Rule. (1) A contractor responsible for a DOE nuclear
facility shall:
(i) Conduct its work in accordance with the criteria of paragraph
(c) of this section;
(ii) Develop and submit for approval by DOE a Quality Assurance
Program (QAP) for the work; and
(iii) Implement the QAP, as approved and modified by DOE.
(b) Quality Assurance Program. (1) A contractor shall develop a QAP
by applying the quality assurance criteria specified in paragraph (c)
of this section. A QAP shall include a discussion of how the criteria
of paragraph (c) of this section will be satisfied. The criteria of
paragraph (c) of this section shall be applied using a graded approach.
The contractor shall use appropriate standards, wherever applicable, to
develop and implement its QAP.
(2) Within 180 days after May 5, 1994, a contractor shall submit to
DOE for approval a current QAP and an implementation plan.
(3) A contractor may, at any time, make changes to an approved QAP.
Changes made over the previous year shall be submitted annually to DOE
for review. A submittal shall identify the changes, the pages affected,
the reason for the changes, and the basis for concluding that the
revised QAP continues to satisfy the requirements of this section.
Changes made to correct spelling, punctuation, or other editorial items
do not require explanation.
(4) Implementation plans and QAPs shall be regarded as approved by
DOE 90 days after submittal, unless approved or rejected by DOE at an
earlier date, and shall include any modification made or directed by
DOE.
(c) Quality assurance criteria.--(1) Management (i) Program. A
written QAP shall be developed, implemented, and maintained. The QAP
shall describe the organizational structure, functional
responsibilities, levels of authority, and interfaces for those
managing, performing, and assessing the work. The QAP shall describe
management processes, including planning, scheduling, and resource
considerations.
(ii) Personnel Training and Qualification. Personnel shall be
trained and qualified to ensure they are capable of performing their
assigned work. Personnel shall be provided continuing training to
ensure that job proficiency is maintained.
(iii) Quality Improvement. Processes to detect and prevent quality
problems shall be established and implemented. Items, services, and
processes that do not meet established requirements shall be
identified, controlled, and corrected according to the importance of
the problem and the work affected. Correction shall include identifying
the causes of problems and working to prevent recurrence. Item
characteristics, process implementation, and other quality-related
information shall be reviewed and the data analyzed to identify items,
services, and processes needing improvement.
(iv) Documents and Records. Documents shall be prepared, reviewed,
approved, issued, used, and revised to prescribe processes, specify
requirements, or establish design. Records shall be specified,
prepared, reviewed, approved, and maintained.
(2) Performance--(i) Work Processes. Work shall be performed to
established technical standards and administrative controls using
approved instructions, procedures, or other appropriate means. Items
shall be identified and controlled to ensure their proper use. Items
shall be maintained to prevent their damage, loss, or deterioration.
Equipment used for process monitoring or data collection shall be
calibrated and maintained.
(ii) Design. Items and processes shall be designed using sound
engineering/scientific principles and appropriate standards. Design
work, including changes, shall incorporate applicable requirements and
design bases. Design interfaces shall be identified and controlled. The
adequacy of design products shall be verified or validated by
individuals or groups other than those who performed the work.
Verification and validation work shall be completed before approval and
implementation of the design.
(iii) Procurement. Procured items and services shall meet
established requirements and perform as specified. Prospective
suppliers shall be evaluated and selected on the basis of specified
criteria. Processes to ensure that approved suppliers continue to
provide acceptable items and services shall be established and
implemented.
(iv) Inspection and Acceptance Testing. Inspection and testing of
specified items, services, and processes shall be conducted using
established acceptance and performance criteria. Equipment used for
inspections and tests shall be calibrated and maintained.
(3) Assessment--(i) Management Assessment. Managers shall assess
their management processes. Problems that hinder the organization from
achieving its objectives shall be identified and corrected.
(ii) Independent Assessment. Independent assessments shall be
planned and conducted to measure item and service quality, to measure
the adequacy of work performance, and to promote improvement. The group
performing independent assessments shall have sufficient authority and
freedom from the line to carry out its responsibilities. Persons
conducting independent assessments shall be technically qualified and
knowledgeable in the areas assessed.
Subpart B--Design [Reserved]
Subpart C--Operations [Reserved]
Subpart D--Material Management [Reserved]
[FR Doc. 94-8123 Filed 4-4-94; 8:45 am]
BILLING CODE 6450-01-P
