[Federal Register Volume 65, Number 196 (Tuesday, October 10, 2000)]
[Rules and Regulations]
[Pages 60292-60317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25453]
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Part III
Department of Energy
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10 CFR Part 830
Nuclear Safety Management; Interim Final Rule
Federal Register / Vol. 65 , No. 196 / Tuesday, October 10, 2000 /
Rules and Regulations
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DEPARTMENT OF ENERGY
10 CFR Part 830
RIN 1901-AA34
Nuclear Safety Management
AGENCY: Department of Energy.
ACTION: Interim final rule and opportunity for public comment.
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SUMMARY: This interim final rule amends the Department of Energy's (DOE
or the Department) nuclear safety regulations to (1) establish and
maintain safety bases for hazard category 1, 2, and 3 nuclear
facilities and perform work in accordance with safety bases, and (2)
clarify that the quality assurance work process requirements apply to
standards and controls adopted to meet regulatory or contract
requirements that may affect nuclear safety. The requirements in this
rule apply to contractor-operated and government-operated nuclear
facilities.
DATES: This rule is effective December 11, 2000. You may send comments
for consideration until November 9, 2000.
ADDRESSES: Comments may be addressed to: Richard Black, Director,
Office of Nuclear and Facility Safety Policy, U.S. Department of
Energy, 1000 Independence Avenue, SW., Washington, DC 20585.
You may also email an electronic copy of your comments to
[email protected].
You may examine written comments between 9:00 a.m. and 4:00 p.m. at
the U.S. Department of Energy Freedom of Information Reading Room, Room
1E-190, 1000 Independence Avenue, SW., Washington, DC 20585, (202) 586-
3142.
FOR FURTHER INFORMATION CONTACT: Richard L. Black, (See address above),
(301) 903-3465, [email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction and Background
A. What Is the Procedural History of this Rule?
On December 9, 1991, we published Procedural Rules for DOE Nuclear
Activities (56 FR 64290) and a Notice of Proposed Rulemaking and Public
Hearing (1991 Notice, 56 FR 64316) to add Parts 820 and 830 to Title 10
of the Code of Federal Regulation (CFR). We proposed 10 CFR Part 820
(Part 820), Procedural Rules for DOE Nuclear Activities, to establish
the procedural requirements for enforcement activities in accordance
with the Price-Anderson Amendments Act of 1988 (PAAA or Price-
Anderson). On August 17, 1993, we issued the Procedural Regulations for
DOE Nuclear Activities in final form as 10 CFR Part 820 (58 FR 43680).
Part 820 establishes the procedures for DOE enforcement actions and for
issuing civil and criminal penalties for contractor, subcontractor, and
supplier violations of DOE nuclear safety requirements.
Part 830 was proposed to establish nuclear safety management
requirements for DOE nuclear facilities. We issued as final the
sections of the Nuclear Safety Management rule (Part 830) related to
the general provisions (Secs. 830.1-830.7) and the quality assurance
requirements (Sec. 830.120) on April 5, 1994 (1994 Notice, 59 FR
15843).
We issued a Notice of Limited Reopening of the Comment Period for
the remaining topics to be addressed in Part 830 on August 31, 1995
(Reopening Notice, 60 FR 45381). The comment period was reopened to
solicit and consider comments on a number of issues which had been
raised since the 1991 Notice. The Reopening Notice provided an
opportunity for contractors and other members of the public to comment
on the effect of recent Department initiatives, such as safe management
systems, the revision of the related nuclear safety Orders, and the
identification of tailored Work Smart Standards (WSS) through the
Necessary and Sufficient Closure Process, and on the scope, level of
detail, and implementation of the proposed rules. We also requested
comments on whether there should be a threshold for the application of
nuclear safety management requirements and whether all nuclear safety
requirements could be implemented in an integrated fashion through, for
example, the use of a site-wide implementation program or system.
B. Has the General Accounting Office (GAO) Made Recommendations About
This Rule?
On June 10, 1999, the GAO issued a report entitled DOE's Nuclear
Safety Enforcement Program Should Be Strengthened. On June 29, 1999,
Assistant Secretary of Environment, Safety and Health, Dr. David
Michaels testified before the House Committee on Commerce that DOE
endorsed the overall GAO conclusion that DOE's enforcement program has
been effective and should be further strengthened. The GAO made three
recommendations which are that DOE:
Expeditiously complete the process of issuing enforceable
rules covering important nuclear safety requirements,
Ensure that field locations are properly following DOE's
guidance in determining which facilities must comply with the nuclear
safety rule on quality assurance, and
Eliminate the administrative exemption from paying civil
penalties for violations of nuclear safety rules that DOE granted to
nonprofit educational institutions.
This rule completes DOE's rulemaking regarding nuclear safety
management. This rule also reaffirms that the quality assurance
requirements of this rule apply to contractors for all DOE nuclear
facilities, including hazard category 1, 2, and 3 nuclear facilities
and ``below hazard category 3 nuclear facilities'' (nuclear facilities
whose hazards are less than hazard category 3) as defined in DOE
Standard (STD) 1027, Change Notice 1, Hazard Categorization and
Accident Analysis Techniques for Compliance with DOE Order 5480.23,
Nuclear Safety Analysis Reports, September 1997, U.S. Department of
Energy, Washington, D.C. 20585.
The PAAA specifically excludes seven nonprofit contractors and
their subcontractors and suppliers from civil monetary penalties for
violations of the nuclear safety requirements. For consistency, 10 CFR
820.20(d) extends that exclusion to all nonprofit educational
institutions. Those exclusions are not within the scope of this rule
and therefore are not discussed in this rulemaking.
C. What Substantive Requirements Are Proposed in This Rule?
In the 1991 Notice, we proposed that the following nine topics be
included in the nuclear safety management rules:
Quality assurance requirements,
Safety analysis reports,
Technical safety requirements,
Unreviewed safety question (USQ),
Conduct of operations,
Maintenance management,
Training and certification,
Defect identification and reporting, and
Occurrence reporting and processing.
The quality assurance requirements were published in 1994 and are
revised in this Notice. The safety basis requirements being added
address three of the topics from the 1991 Notice: safety analysis
reports, technical safety requirements, and USQ. Three of the remaining
five nuclear safety management topics from the 1991 Notice (conduct of
operations, maintenance management, and training and certification) are
expected to be addressed through the documented safety analysis
required by the safety basis requirements and the work processes
required by the quality
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assurance requirements. Specifically, the documented safety analysis
will establish what training, maintenance, and conduct of operations
are required for safety. Compliance with the safety basis and quality
assurance provisions of this rule will ensure that these safety
functions are established, maintained, and implemented.
Defect identification and occurrence reporting and processing will
continue to be addressed through contract provisions that require
contractors to use the DOE Occurrence Reporting and Processing System
(ORPS). We intend to maintain DOE Order 232.1A, Occurrence Reporting
and Processing of Operations Information, and DOE Manual 232.1-1A,
Occurrence Reporting and Processing of Operations Information, so that
they can be adopted through contract requirements. Consequently, we
believe that the nine topics proposed in the 1991 Notice are adequately
covered through the combination of this rule and contract requirements.
D. Why Is DOE Issuing This Rule as an Interim Final Rule?
We are issuing this rule as an interim final rule to give the
public further opportunity to comment. The public has until November 9,
2000 to submit comments on the rule. This regulation then becomes
effective December 11, 2000. If DOE decides to amend this rule based on
comments received, we will issue a Federal Register Notice to state
those changes; otherwise this rule will become effective, as written,
on December 11, 2000. Pending the effective date of this new rule, the
quality assurance provisions of the current rule in 10 CFR 830.120
remain in effect and fully enforceable.
II. Summary of Changes
The changes to Part 830 are primarily to
Convert the rule to ``plain language'',
Clarify the scope of the rule,
Add provisions requiring the integration of quality
assurance with the Safety Management System (SMS) [Part 830, Subpart
A],
Clarify that the work process provisions of quality
assurance apply to standards and controls adopted to meet regulatory
and contractual requirements relating to nuclear safety [Part 830,
Subpart A], and
Add provisions for nuclear facility safety bases [Part
830, Subpart B].
Plain Language
A. Why Is DOE Converting the Rule to Plain Language?
In 1998, President Clinton signed a presidential memo requiring
agencies to use plain language principles for most of their written
communications. While this memo does not require us to use plain
language for regulations that were proposed before January 1, 1999, we
chose to revise it in the plain language style because we were revising
a substantial portion of Part 830. Plain language requirements vary
depending upon the document, but the intent is to make the government
language easier to understand. We are reformatting the rule to use
Common, everyday words, except for necessary technical
terms;
Active voice; and
Short sentences.
The word ``shall'' is being replaced with the word ``must'' to
indicate an obligation. The word ``may'' is used for permission.
Because we are revising the text of the rule to the plain language
format, we have rewritten the quality assurance requirements in this
rule; however there are few significant changes. The significant
changes are described in this summary.
General Sections
B. What Changes Are Made to Sec. 830.1, Scope?
Section 830.1, Scope, is being revised to state that the rule
governs the conduct of DOE contractors, DOE personnel, and other
persons conducting activities (including providing items and services)
that affect, or may affect, the safety of DOE nuclear facilities.
Previously, Part 830 only applied to activities conducted at a DOE
nuclear facility. This change will ensure that Part 830 requirements
are applicable to all activities performed for or on behalf of DOE that
have the potential to affect nuclear safety. Some activities subject to
Part 830 requirements may occur outside a nuclear facility and even may
be conducted off a DOE site. The nuclear safety management requirements
may apply to these activities. If a supplier furnishes safety items or
services that either are, or will be, used at a nuclear facility, then
that supplier falls within the scope of the rule provisions. Similarly,
contractor activities performed in support of facility operations, such
as training of operators or maintenance of safety equipment, fall under
the scope of the rule to the extent the activities relate to nuclear
safety. Furthermore, a nonreactor nuclear facility is broadly defined
to include not only buildings, but also activities and operations
involving radioactive and/or fissionable materials in such form or
quantity that a nuclear hazard or a nuclear explosive hazard
potentially exists to workers, the public, or the environment.
We also are revising Paragraph 830.1 to add ``DOE personnel.'' This
change is consistent with the change to paragraph 830.4(d).
C. What Changes Are Made to the Exclusions in Sec. 830.2?
The exclusion for the Nuclear Explosives and Weapons Safety Program
(weapons exclusion) is being deleted. Three new exclusions are being
added relating to:
Transportation;
Facilities and activities conducted under the Nuclear
Waste Policy Act of 1982, as amended (NWPA); and
Activities related to the launch approval and actual
launch of nuclear energy systems into space.
In addition, the reference to the Public Law authorizing the
Director Naval Nuclear Propulsion has been updated to Public Law 106-
65. Public Law 106-65 also established the National Nuclear Security
Administration in DOE.
Deletion
Nuclear Explosives and Weapons Safety Program. When we proposed the
Nuclear Safety Management rule (Part 830) in the 1991 Notice and the
Reopening Notice, we were concerned that conflicts could arise between
nuclear safety requirements and the nuclear explosives weapons safety
requirements. Today we are including specific methods by which nuclear
explosive operations and their associated activities may meet Subpart B
to Part 830 that are consistent with nuclear explosives safety.
Therefore, we no longer need to exclude the Nuclear Explosives and
Weapons Safety program, and we are deleting that exclusion. This change
makes clear that this rule applies to nuclear explosives facilities and
their associated nuclear explosive operations and activities.
Additions
1. Transportation. All transportation activities were excluded in
the definition of nonreactor nuclear facility published in the 1994
Notice. The definition of nonreactor nuclear facility that we are
publishing today does not exclude transportation activities. Instead,
we are adding an exclusion for certain transportation activities to
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Sec. 830.2. The exclusion for transportation activities in paragraph
830.2(d) is narrower than the exclusion for transportation activities
previously contained in the definition for nonreactor nuclear facility.
It only excludes transportation activities that are regulated by the
Department of Transportation (DOT). We are excluding transportation
activities that are regulated by DOT to avoid duplicate regulation by
DOE and DOT. Transportation issues are discussed in greater detail in
the discussion of responses to public comments.
2. Activities conducted under the NWPA. These activities are
designated for licensing by the Nuclear Regulatory Commission (NRC),
and the design and construction of these activities must meet NRC
requirements in order for them to receive an NRC license. Facilities
that are licensed by the NRC are already excluded from this Part
following issuance of a license to operate by the NRC. This new
exclusion will cover activities under the NWPA for the period of time
preceding licensing by the NRC. An example of an activity conducted
under NWPA is the Yucca Mountain Project. Activities conducted under
NWPA should implement and comply with NRC regulations in anticipation
of NRC licensing, not DOE nuclear safety regulations. Therefore, they
are excluded from this rule.
3. Activities related to the launch approval and actual launch of
nuclear energy systems. The new exclusion recognizes that some nuclear
energy systems are developed and built by DOE contractors for missions
to be launched into space. These missions are generally sponsored by
the National Aeronautics and Space Administration. Safety analyses
activities for such systems are conducted consistent with established
executive policy and applicable DOE directives for systems and
equipment developed for space launches, and the results of that
analysis will be considered during launch decisions. Because these
analyses are performed for other government agencies and approved by
the Office of the President, they do not need to be governed by the
requirements in Part 830. Manufacturing, assembly, and testing of these
systems by DOE contractors are not excluded from this rule.
D. What Changes Are Made to Sec. 830.3, Definitions?
We are adding, revising, and deleting a number of definitions in
Part 830 to support new requirements or the formatting change to plain
language.
Added Definitions. We are adding the following definitions
for use in Part 830: bases appendix; critical assembly; criticality;
design features; documented safety analysis; environmental restoration
activities; existing DOE nuclear facility; hazard controls; limiting
conditions for operation; limiting control settings; low-level residual
fixed radioactivity; major modification; new DOE nuclear facility;
operating limits; preliminary documented safety analysis; safety basis;
safety class structures, systems, and components; safety evaluation
report; safety limits; Safety Management System; safety management
program; safety significant structures, systems, and components; safety
structures, systems, and components; surveillance requirements;
technical safety requirements; Unreviewed Safety Question; Unreviewed
Safety Question process; and use and application provisions. Additional
discussion on these added definitions is provided in the following
paragraphs.
a. Basis appendix, design features, limiting conditions for
operation, limiting control settings, operating limits, safety limits,
surveillance requirements, and use and application provisions. These
are all terms that are used in Subpart B of Part 830 to describe the
DOE requirements for hazard controls in the form of technical safety
requirements. These terms are also currently used in DOE Order 5480.22,
Technical Safety Requirements, and are intended to be consistent with
that order.
b. Critical assembly. The term critical assembly is used in this
rule to define the term reactor. Critical assembly was formerly defined
within the definition for reactor. It is listed as a separate
definition to simplify the definition of reactor.
c. Criticality. Criticality is the condition in which a nuclear
fission chain reaction becomes self-sustaining. A contractor
responsible for a nuclear facility with fissionable material in a form
and amount sufficient to pose a potential for criticality is required
to define their criticality safety program in their documented safety
analysis.
d. Documented safety analysis. A documented safety analysis is a
report that documents the adequacy of the analysis of a facility or
activity to ensure that it can be constructed, operated, performed,
maintained, shut down, and decommissioned safely and in compliance with
applicable requirements. Depending upon the type of facility and the
method approved by DOE to prepare a documented safety analysis for the
facility, the documented safety analysis might be in the form of a
safety analysis report, a Basis for Interim Operation or BIO (prepared
in accordance with DOE-STD-3011-94, Guidance for Preparation of DOE
5480.22 (TSR) and DOE 5480.23 (SAR) Implementation Plans, November 1994
or its successor document), a safety and health plan or HASP (as
defined in 29 CFR 1910.120 or 1926.65), or a combination of a safety
analysis report and a hazard analysis report (HAR). This term is used
in the new safety basis requirements.
e. Environmental restoration activities. Environmental restoration
activities are the processes by which contaminated sites and facilities
are identified and characterized. It is also the process by which
existing contamination is contained or removed. These activities
include environmental remediation of contaminated soils. Environmental
restoration activities are considered to be nuclear facilities if the
activities involve radioactive and/or fissionable materials in such
form and quantities that a nuclear hazard or a nuclear explosive hazard
potentially exists. This term is used in the new safety basis
requirements.
f. Existing DOE nuclear facility and new DOE nuclear facility. This
rule imposes different safety basis requirements in Subpart B for new
facilities versus existing facilities. The first difference is related
to the development of a preliminary documented safety analysis for new
nuclear facilities, which is not required for existing nuclear
facilities. The second difference is with respect to schedules as
specified in the rule. We consider an existing DOE nuclear facility to
be a DOE nuclear facility that is or has been in operation prior to
April 9, 2001. New nuclear facilities are facilities, activities and
operations that begin operations on or after April 9, 2000.
For activities, such as decontamination or environmental
restoration, for which the term ``operate'' is less clear, DOE intends
the term to mean from the date a new decontamination or environmental
restoration activity begins.
We consider new DOE nuclear facilities to include (1) construction
of a new DOE facility which is intended to be used as a nuclear
facility; (2) use of an existing non-nuclear DOE facility to possess,
use or store radioactive or fissionable material in such form and
quantity that a nuclear hazard potentially exists; and (3) initial
possession, use, or storage of radioactive or fissionable material in
such form and
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quantity that a nuclear hazard potentially exists. We also consider the
change from operation of a DOE nuclear facility to deactivation,
decontamination, decommissioning, or environmental restoration to be a
new DOE nuclear activity subject to the schedules for a new nuclear
facility.
Many DOE nuclear facilities, particularly those that perform
nuclear explosives operations, are designed to accommodate changing
missions. These facilities and activities require both a generic form
of documented safety analysis and an operation- or activity-specific
form of documented safety analysis. One form of operation- or activity-
specific documented safety analysis is defined in Appendix A, Table 3
as a specific nuclear explosive operation. We do not consider a
specific nuclear explosive operation to be a ``new DOE nuclear
facility.''
g. Hazard controls. Hazard controls means measures to eliminate,
limit, or mitigate hazards to workers, the public, or the environment
including (1) physical, design, structural and engineering features;
(2) safety structures, systems and components; (3) safety management
programs; (4) technical safety requirements; and (5) other controls
necessary to provide adequate protection from hazards. Although the
hazard controls are required to address nonradiological hazards as well
as radiological hazards, we will only pursue PAAA enforcement actions
for noncompliances that have nuclear safety significance.
h. Low-level residual fixed radioactivity. Low-level residual fixed
radioactivity is the radioactivity remaining following reasonable
efforts to remove radioactive systems, components, and stored materials
and is composed of:
Surface contamination that remains fixed following
chemical cleaning or some similar process;
A component of surface contamination that can be picked up
by smears; or
Activated materials within structures.
Although the definition permits some smearable surface
contamination (i.e., removable contamination), the smearable
radioactivity must be less than the values defined for removable
contamination by 10 CFR Part 835, Appendix D, Surface Contamination
Values. In addition, the results of the hazard analysis must show that
no credible accident scenario or work practices would release the fixed
or activated components of remaining radioactivity at levels that would
prudently require the use of active safety systems, structures, or
components to prevent or mitigate a release of radioactive materials.
This definition is generally consistent with the definition for
this term in DOE-STD-1120-98, Integration of Environment, Safety and
Health into Facility Disposition Activities, May 1998.
i. Major modification. A major modification means a modification to
a DOE nuclear facility that is completed on or after April 9, 2001 and
which substantially changes the existing safety basis for the facility.
Because these changes have a significant effect on the safety basis of
a nuclear facility, we expect contractors to develop a preliminary
documented safety analysis that addresses these modifications and their
impacts on the safety of the nuclear facility so DOE may review the
proposed changes before they are implemented. Before operating the
nuclear facility in the modified configuration or conducting modified
operations, contractors must obtain approval of the upgraded safety
basis from DOE and make any changes to the safety basis directed by
DOE.
We treat major modifications to hazard category 1, 2, and 3 DOE
nuclear facilities, such as the replacement of a major safety system,
equivalent to the design, construction, and initial operation of a new
facility. Because contractors for major modifications must revise their
safety basis documents to reflect the major modifications and obtain
DOE approval of the revised safety bases prior to making the
modification, they do not need to assess major modifications under the
USQ process of Subpart B.
j. Preliminary documented safety analysis. The preliminary
documented safety analysis is the documentation prepared in connection
with the design and construction of a new hazard category 1, 2, or 3
DOE nuclear facility or a major modification to a hazard category 1, 2,
or 3 DOE nuclear facility. It is part of the safety basis requirements,
and it serves as the principal safety basis for the DOE decision to
authorize procurement, construction, or preoperational testing.
k. Safety basis. A safety basis for a DOE nuclear facility is
documented in the documented safety analysis and the hazard controls
for the nuclear facility. As changes are made or potential inadequacies
of the safety analysis are discovered, contractors must perform USQ
determinations. The results of the USQ determinations and any
associated safety evaluations are part of the safety basis for the
facility.
l. Safety class structures, systems, and components. Safety class
structures, systems, and components means structures, systems, or
components, including portions of process systems, whose preventive or
mitigative function is necessary to limit radioactive hazardous
material exposure to the public, as identified by the safety analysis.
m. Safety evaluation report or SER. The SER is the documented
safety evaluation performed by DOE on the safety basis documents for a
facility that are developed by the contractor. It includes the reasons
for approving the safety basis and any conditions for approval.
Contractors are required by the safety basis requirements to meet any
conditions stated in the SER.
n. Safety Management System (SMS). Safety Management System means
an integrated safety management system established consistent with the
Department of Energy Acquisition Regulation (DEAR) in 48 CFR 970.5204-
2, Integration of Environment, Safety, and Health into Work Planning
and Execution, or any successor regulation. Additional information on
SMS may be found in DOE Policy 450.4, Safety Management System Policy;
DOE Guide 450.4-1A, Integrated Safety Management System Guide.
o. Safety management program. Safety management programs are
programs designed to ensure a facility is operated in a manner that
adequately protects workers, the public, and the environment.
Contractors may have already developed safety management programs to
comply with contract requirements for Safety Management Systems.
Subpart B of the rule requires contractors to define the
characteristics of the safety management programs for the facility that
are necessary for safe operations, including, where applicable, quality
assurance, procedures, maintenance, personnel training, conduct of
operations, emergency preparedness, fire protection, waste management,
and radiation protection. They may also include criticality safety
programs for nonreactor nuclear facilities with fissionable material in
a form or amount sufficient to pose a potential for criticality. Rather
than repeating or reinventing these programs for the documented safety
analysis, contractors may incorporate existing programs by reference
into the documented safety analysis provided these programs are
sufficient to provide adequate protection. Contractors may need to
include a copy of documents that are incorporated by reference with the
documented safety analysis when it
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is submitted to DOE for review and approval.
p. Safety significant structures, systems, and components. Safety
significant structures, systems, and components means systems,
structures, and components which are not designated as safety class
systems, structures, and components, but whose preventive or mitigative
function is a major contributor to defense in depth (i.e., prevention
of uncontrolled material release) and/or worker safety as determined
from hazard analyses.
q. Safety structures, systems, and components. Safety structures,
systems, and components are the combination of safety class systems,
structures, and components and safety significant systems, structures,
and components.
r. Technical safety requirements. Technical safety requirements are
the limits, controls and related requirements necessary for the safe
operation of a nuclear facility that are appropriate for the work and
the hazards. Technical safety requirements include safety limits,
operating limits, surveillance requirements, administrative and
management controls, use and application provisions, and design
features, as well as a bases appendix. These requirements are also
consistent with the criteria for technical safety requirements in DOE
Order 5480.22 which generally have been implemented by contractors for
DOE hazard category 1, 2, and 3 nuclear facilities.
s. Unreviewed Safety Question (USQ). A situation involves a USQ if
(1) the probability of the occurrence or the consequences of an
accident or the malfunction of equipment important to safety previously
evaluated in the documented safety analysis could be increased; (2) the
possibility of an accident or malfunction of a different type than any
evaluated previously in the documented safety analysis could be
created; (3) a margin of safety could be reduced; or (4) the documented
safety analysis may not be bounding or may be otherwise inadequate. If
a situation involves a USQ, the contractor must use the USQ process to
determine if the change or the potential inadequacy of the documented
safety analysis needs to be submitted to DOE for review and approval.
t. Unreviewed Safety Question Process. The USQ process permits a
contractor to make physical and procedural changes to a nuclear
facility and to conduct tests and experiments without prior DOE
approval, provided these changes do not explicitly or implicitly affect
the safety basis of the nuclear facility. The USQ process provides a
contractor with the flexibility needed to conduct day-to-day operations
by requiring that only those changes and tests with a potential to
impact the safety basis (and therefore the safety of the nuclear
facility) be brought to the attention of DOE. This allows DOE to focus
its review on those changes significant to safety. The USQ process is
an important tool for keeping the safety basis current by ensuring
changes are appropriately reviewed and incorporated into the safety
basis. The USQ process provides a method for contractors to determine
if a USQ is involved and the actions to take if the situation involves
a USQ. DOE approval is required before a change is made that affects
the safety basis of a DOE nuclear facility.
2. Revised Definitions
The following terms are continued in this Part, but their
definitions are revised:
a. Document. The second sentence of this definition regarding when
a document is a record is being deleted as unnecessary to the
definition. This change does not affect the meaning of the terms
document and record.
b. Graded Approach. The definition of graded approach is being
revised to include an additional condition for grading: ``the relative
importance of radiological and nonradiological hazards.''
c. Hazard. Minor editorial changes were made that do not affect the
meaning.
d. Nonreactor nuclear facility. We are making the following changes
to the definition for nonreactor nuclear facility.
i. Facilities. We are adding the word ``facilities'' in the
definition so that it reads ``Nonreactor facilities means those
facilities, operations and activities * * *'' to make it clear that
facilities are included in the definition. The word ``facility'' as it
is used in this term is broadly defined to include buildings,
operations, and activities and, in some cases, the surrounding area.
ii. Nuclear explosive hazard. We are adding the words ``* * * or a
nuclear explosive hazard * * *'' to clarify that nuclear explosive
facilities, and the nuclear explosive operations conducted therein, are
included in the definition of nonreactor nuclear facility.
iii. Transportation exclusion. We are deleting the exclusion of
transportation activities from the definition, but we are continuing to
exclude transportation activities regulated by DOT from the scope of
Part 830 through an added exclusion in Sec. 830.2. This narrows the
exclusion for transportation activities and is discussed in greater
detail in the response to public comments.
iv. Examples. The definition of nonreactor nuclear facility
previously listed six examples of facilities and activities to be
included in the definition. Some persons took these examples to mean
that nonreactor nuclear facilities were limited to the specific
examples stated. We are deleting the six examples because we do not
want to imply that this is a definitive list. Except for the change
relating to services to nuclear facilities, which is discussed in the
next paragraph, the deletion of the six examples is not intended to
change the scope of the definition of nonreactor nuclear facilities.
v. Services. The previously listed examples of nonreactor nuclear
facilities included design, manufacturing, and assembly. While we
continue to consider design, manufacturing, and assembly to be
important to the safe operation of a nuclear facility, under the
revised definition for a nonreactor nuclear facility, unless the
facility where these activities occur also involves, or will involve,
radioactive and/or fissionable materials in such form and quantity that
a nuclear hazard potentially exists, it is no longer considered to be a
nuclear facility. Rather, these activities are considered to be
services. Furthermore, we have clarified the requirements in the rule
relating to services which are provided to nuclear facilities.
The change relating to services provided to a nuclear facility will
affect the application of the rule to facilities which provide services
to nuclear facilities, but do not use, possess, or store radioactive or
fissionable materials. Under this change, contractors for facilities
which provide items and services that may affect nuclear safety, but do
not use, store, or possess radioactive or fissionable materials (now or
at a later date), must perform their activities in accordance with the
quality assurance criteria of Subpart A of this rule, but are not
required by this rule to submit a Quality Assurance Program (QAP) to
DOE for approval. They may, however, have separate contract
requirements for a QAP that they will need to meet. In addition,
facilities that provide services or items, but do not expect to use,
store, or possess radioactive or fissionable material now or in the
future, are not required to meet the safety basis requirements of
Subpart B. This change is consistent with the changes to the scope
(Sec. 830.1) relating to items and services that may affect nuclear
safety.
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vi. Incidental Use. We are continuing to exclude incidental use
from the definition of nonreactor nuclear facility, however we are
making a minor revision to one of the examples. We are adding the word
``radiation'' to read ``Incidental use and generation of radioactive
materials or radiation including . . . '' This change is to acknowledge
that the use of X-ray machines and electronic microscopes does not
involve radioactive materials but does produce radiation. This
exclusion is for activities that involve such insignificant amounts of
radioactive materials or radiation (e.g., X-ray machines, check and
calibration sources, electron microscopes, use of radioactive sources
in research, experimental, and analytical laboratory activities) that
the amounts do not warrant consideration as a nuclear facility and
their use does not need to be regulated by this rule. However, some of
the uses would still be subject to the radiation protection
requirements in 10 CFR Part 835 (Part 835), Occupational Radiation
Protection. Other applications of this rule to incidental uses will be
handled by DOE on a case-by-case basis.
e. Nuclear facility. We are revising the definition of nuclear
facility to make it clear that nuclear facilities include any related
area, structure, facility, or activity to the extent necessary to
ensure proper implementation of the requirements established by Part
830. The nuclear facility may be on or off a DOE site. The facility may
be wholly or partially owned or controlled by DOE. This change was
made, in part, to address concerns stated in the GAO report that the
term nuclear facility was being interpreted too narrowly for purposes
of applying the Part 830 requirements.
Nuclear facilities include facilities, operations, and activities
whose intended use will require them to possess, use, or form
radioactive or fissionable materials. Many activities performed at or
for facilities where fissionable material will be stored, used, or
formed take place before the introduction of these materials at the
facility. Consequently, nuclear facilities also include facilities that
will use, store, or possess radioactive or fissionable material in a
form or quantity that a nuclear hazard potentially exists to workers or
the public.
Nuclear facilities include both reactors and nonreactor nuclear
facilities. A nonreactor nuclear facility is broadly defined to include
facilities, activities, and operations involving the possession, use,
or formation of radioactive or fissionable materials that are conducted
by or on behalf of DOE regardless of whether they are conducted onsite
or offsite. The term ``DOE nuclear facility'' and ``nuclear facility''
are used interchangeably in the rule because those terms relate to
those activities conducted by or on behalf of DOE that affect or may
affect the safety of DOE nuclear facilities. The use of the term ``DOE
nuclear facility'' does not necessarily require the facility to be
owned by DOE.
f. Quality Assurance Program or QAP. We are making a minor change
to the definition of QAP to add the words ``or management system'' to
clarify that the QAP is a management system.
g. Reactor. We are changing the definition of reactor to move the
definition of critical assembly to a separate definition. The
definition of reactor is also being revised to read more clearly. These
changes do not affect the meaning of the definition.
h. Service. We are adding the following terms to the definition of
service to make clear that these are services: manufacturing, assembly,
decontamination, environmental restoration, waste management, and
laboratory sample analyses.
3. Deleted Definitions
We are deleting the definitions for contractor, Department or DOE,
and person from this rule and incorporating them by reference to the
Atomic Energy Act (Act) and 10 CFR Part 820. Paragraph 830.3(b) is
revised to read ``(b) Terms defined in the Act or in 10 CFR Part 820
and not defined in this section of the rule are used consistent with
the meanings given in the Act or in 10 CFR Part 820.'' We are deleting
the definition for Implementation Plan because the term is no longer
used in Part 830.
E. What Changes are Made to Sec. 830.4, General Requirements?
1. Changes to Paragraph 830.4(a)
We are deleting the language in paragraph 830.4(a) that referred to
plans, programs, schedules, or other processes. This language is
redundant to the requirement in 10 CFR 820.20(b)(3) and, therefore, is
not needed.
2. Changes to Paragraph 830.4(b)
The contractor responsible for a nuclear facility is also expected
to ensure compliance with the rule. We have simplified the language but
there is no substantive change.
The ``contractor responsible for a nuclear facility'' is the
``prime contractor'' for the facility. The prime contractor is the
contractor whose work for the facility (including operations and
activities) is contracted directly with DOE. The prime contractors
include management and operating (M&O) contractors, management and
integration (M&I) contractors, and environmental restoration
contractors. DOE expects its prime contractors to implement mechanisms
to oversee and ensure that subcontractors and suppliers comply with the
nuclear safety management requirements. Furthermore, prime contractors
are expected to incorporate these expectations and the associated
programs in contracts and other procurement documents with their
subcontractors and suppliers. This requirement does not relieve
subcontractors and suppliers from their responsibilities in accordance
with this rule.
3. Changes to Paragraph 830.4(c)
We are rewriting paragraph 830.4(c) to state that the requirements
of Part 830 must be implemented in a manner that provides reasonable
assurance of adequate protection. This is consistent with DOE's
statutory mandate under the Act. Paragraph 830.4(c) also requires
contractors to implement the requirements in a manner that takes into
account the work to be performed and the associated hazards. This is
consistent with the principles of integrated safety management and the
concept of grading.
4. Addition of Paragraph 830.4(d)
We are adding a new paragraph 830.4(d) to state where there is no
contractor for a DOE facility, DOE must ensure implementation and
compliance with the requirements of this Part. This amendment makes the
requirements of this rule applicable to government-owned, government-
operated (GOGOs) DOE nuclear facilities, as well as the nuclear
facilities that are operated by contractors. Many of the requirements
in this rule are addressed to contractors. Paragraph 830.4(d) makes
clear that where DOE, rather than a contractor, is responsible for
operating a nuclear facility, DOE must ensure that the activities and
operations for that facility meet the requirements of this rule.
F. What Changes are Being Made to Sec. 830.7, Graded Approach?
This section is being changed to state that, where appropriate,
contractors must use a graded approach to implement the requirements of
Part 830 and they must document the basis of the graded approach used.
Contractors are already required to implement the
[[Page 60298]]
quality assurance requirements using a graded approach. The use of the
graded approach is not appropriate in implementing the USQ process or
in implementing technical safety requirements that establish clearly
defined limits or actions.
Subpart A
Quality Assurance Requirements
G. What Changes are Being Made to the Scope and the Format of the
Quality Assurance Requirements in Subpart A?
First, we are changing the numbering of the quality assurance
requirements. Subpart A is being renamed to ``Quality Assurance
Requirements'' and the requirements are contained in Secs. 830.120,
830.121, and 830.122. Second, we are changing the format of the quality
assurance requirements to read in plain language.
We are making conforming changes to the quality assurance
requirements to agree with the changes made to the scope of Part 830
(Sec. 830.1) and to the definitions of contractor, nuclear facility,
and services. We have revised the scope of the quality assurance rule
to require contractors (including those responsible for supplying items
and services) that conduct activities that affect, or may affect, the
safety of a nuclear facility to conduct work in accordance with the
quality assurance criteria of Sec. 830.122. This makes clear that
quality assurance requirements apply not only to prime contractors
responsible for a nuclear facility, but also to subcontractors,
suppliers, and other contractors, including those who provide items
(such as pumps, valves, waste containers, piping, and electrical or
mechanical devices) or services (such as design, engineering,
maintenance, and welding) that affect, or could affect, nuclear safety.
The quality of procured items such as fire suppression equipment may,
or may not, affect nuclear safety depending upon the application of the
equipment. DOE expects the contractor responsible for the nuclear
facility (typically the prime contractor) to determine how to flow the
quality assurance requirements down to subcontractors and suppliers, as
well as the method for ensuring that procured items and services meet
requirements and perform as expected. The contractor must also
determine if the subcontractor or supplier is capable of providing
items and services that meet the requirements including the quality
assurance criteria. We have added a requirement for the QAP to describe
how the contractor responsible for a nuclear facility ensures that
subcontractors and suppliers satisfy the quality assurance criteria.
The scope of Sec. 830.120 makes clear that the quality assurance
criteria may apply to activities outside a nuclear facility, and even
those conducted off a DOE site, if they can affect the safe operation
of a DOE nuclear facility.
H. Are Subcontractors and Suppliers Expected To Submit a QAP to DOE for
Approval?
As stated in the preamble to the 1994 Notice, subcontractors and
suppliers are not expected to submit QAPs to DOE for review and
approval. The requirement in the rule for contractors to submit QAPs to
DOE for approval applies only to the contractors responsible for the
nuclear facility (the prime contractors). However, while only
contractors responsible for the nuclear facility are required by this
rule to submit QAPs to DOE for approval, prime contractors are expected
to use their contracts and other arrangements with subcontractors and
suppliers to define what procured items or services are subject to
quality assurance requirements (including QAPs) and how their
subcontractors and suppliers are to comply with those requirements.
Criterion 7 in the Quality Assurance Requirements requires contractors
to (a) procure items and services that meet established requirements
and perform as specified, (b) evaluate and select prospective suppliers
on the basis of specified criteria, and (c) establish and implement
processes to ensure that approved suppliers continue to provide
acceptable items and services. This criterion is meant to ensure that
safety components do not fail while in service and that the fabrication
or assembly of safety-related components and systems meet design
specifications.
To the extent a contract or a related document states that a
subcontractor or supplier must comply with a QAP, the subcontractor or
supplier must meet that requirement. Any person, including
subcontractors or suppliers subject to the requirements in a QAP, may
be subject to enforcement actions under 10 CFR Part 820 if those
requirements are violated.
I. What Changes Are Being Made to the Requirements for the QAP?
We are:
Adding a requirement for contractors to identify and
document the voluntary consensus standards they relied upon to develop
and implement their QAP,
Adding a requirement for contractors with an SMS to
integrate the SMS with the QAP,
Clarifying that the work process provision is to be read
broadly to include all standards and controls adopted to meet
regulatory and contract requirements, and
Making a number of format and plain language changes with
no substantive effect.
J. Why Are We Requiring Contractors To Identify the Voluntary Consensus
Standards They Use?
Most contractors use standards (e.g., American Society of
Mechanical Engineers' NQA-1 standard) to develop their QAPs, but they
have not always documented their use of these standards in the QAP. We
are adding this requirement to ensure we clearly understand what
voluntary consensus standards contractors are using to develop their
QAPs. This is consistent with the requirement in the National
Technology Transfer and Advancement Act of 1995 (Public Law 104-113)
that government agencies adopt or use voluntary consensus standards
when they are applicable and appropriate.
K. Why Is DOE Adding a Requirement for Contractors To Integrate Their
QAP With Their SMS?
The Department expects that quality assurance criteria and
practices will be embedded in all work processes, not just those that
relate to nuclear safety. Therefore, the actions to implement the
quality assurance criteria should be integrated with and consistent
with the commitments in the SMS. This helps ensure that quality
assurance criteria and practices will apply to all work processes that
are implemented for safety management. For this reason, we are adding
Sec. 830.121(c)(2) to require contractors to integrate their QAP with
their SMS. In addition, we wanted to provide a means for contractors to
combine the two documents if they wished to reduce the paperwork burden
so we have included an option that permits contractors to combine the
QAP and the SMS into a single document. The two ways a contractor can
document the integration of its QAP and its SMS are:
The contractor may choose to retain its QAP and its SMS
description as separate documents. If the contractor does this, its QAP
must describe how the contractor applied the quality assurance criteria
of Sec. 830.122 to its integrated SMS; or
The contractor may choose to integrate its QAP into its
SMS description and not have a separate QAP. If the contractor does
this, its SMS description must describe how the quality assurance
criteria of Sec. 830.122 are met.
[[Page 60299]]
If the contractor chooses to maintain a separate QAP and the DOE-
approved QAP does not address SMS integration and standards
identification, the contractor will need to revise its QAP. The
contractor may wait and submit its revised QAP to meet the SMS
integration requirement at the time of its next annual update of its
QAP. We recently revised our Quality Assurance Management System Guide
(DOE G 414.1-2) for use with 10 CFR 830.120. The guide provides
information on how quality assurance integrates with and supports the
Department's SMS policy.
Use of this guide will facilitate implementation of
Sec. 830.121(c)(2) and the effective integration of the quality and
safety management systems.
This change is consistent with provisions of 48 CFR 970.5204-2 that
state contractors are to provide SMS descriptions. If the contractor
does not have a DOE-approved SMS, it is not required to integrate its
QAP with its SMS.
L. Why Is DOE Deleting the Requirement for a Quality Assurance
Implementation Plan?
Implementation plans were an option made available for contractors
who needed a transition period for bringing existing facilities and
activities into compliance with the quality assurance requirements. The
regulatory requirements for a QAP were issued over six years ago and
there is no longer any need for a transition period.
M. Why Is DOE Clarifying the Work Process Provision?
We are revising criterion 5 on work processes to make clear that
work must be performed in accordance with standards and hazard controls
adopted to meet contract or regulatory requirements. This clarification
provides added emphasis that contractor work processes are very broadly
interpreted under the quality assurance requirements and includes work-
related standards, instructions, procedures, administrative controls,
technical safety requirements, and other hazards controls.
Subpart B
N. What Changes Are Being Made to Subpart B?
We are adding Secs. 830.201 through 830.207 to Subpart B of Part
830 to include requirements for contractors to develop safety basis
documents for DOE hazard category 1, 2, and 3 nuclear facilities and
comply with those documents. These changes are discussed in greater
detail in the Discussion of Safety Basis Requirements in Subpart B.
Subparts C and D
O. Is DOE Continuing to Reserve Subparts C and D?
Subparts C and D, which were reserved for future rulemaking are no
longer needed and, consequently, are being deleted.
III. Discussion of Safety Basis Requirements in Subpart B
Section 830.200, Scope
A. Do the Safety Basis Requirements Apply to all DOE Nuclear
Facilities?
No. The safety basis requirements of this Part only apply to DOE
hazard category 1, 2, and 3 nuclear facilities. Unlike the general and
quality assurance requirements of this rule, the safety basis
requirements do not apply to contractors for ``below hazard category
3'' nuclear facilities. DOE expects its contractors to retain
documentation for each of its nuclear facilities to support the
determination that the nuclear facility is either a hazard category 1,
2, or 3 nuclear facility or below category 3.
In summary, using DOE-STD-1027, a hazard category 1 nuclear
facility has the potential for significant offsite consequences. A
hazard category 2 nuclear facility has the potential for significant
on-site consequences beyond localized consequences. A hazard category 3
nuclear facility has the potential for only local significant
consequences. A below hazard category 3 facility has the potential for
consequences less than the other categories. Below category 3
facilities are sometimes referred to as ``radiological facilities.''
While the safety basis provisions in Subpart B do not apply to below
hazard category 3 nuclear facilities, the QA requirements in Subpart A
and the occupational radiation protection requirements in 10 CFR Part
835 do apply.
Section 830.201, Performance of Work
B. What Are the ``Performance of Work'' Requirements for a Safety
Basis?
Contractors must perform work in accordance with the DOE-approved
safety basis for a DOE hazard category 1, 2, or 3 nuclear facility.
This includes prime contractors to DOE, subcontractors, and suppliers.
The definition of ``work'' as applied to this rule is very broad and
encompassing. It includes any defined task or activity that may affect
a safety basis for a facility. It includes such diverse activities as
operations, research and development, environmental restoration and
remediation, maintenance and repair, design and construction, software
development and use, inspection, data collection, administration, and
analysis.
Section 830.202, Safety Basis
C. What Are the Requirements for Establishing a Safety Basis for a DOE
Category 1, 2, or 3 Nuclear Facility?
The proper analysis of facility, operations, and activity hazards,
the development of appropriate hazard controls for the work to be
conducted, and the performance of work consistent with the approved
safety basis are necessary for work at nuclear facilities to be
performed safely. The safety basis requirements in this rule are
derived from the proposal for requirements in the 1991 Notice and in
the Reopening Notice under Sec. 830.110, Safety Analysis Report,
Sec. 830.112, Unreviewed Safety Question Requirements, and
Sec. 830.310, Technical Safety Requirements, and are updated versions
of the underlying requirements in DOE Orders on nuclear safety. While
safety basis requirements already exist in DOE Orders and are imposed
through contracts, we consider the requirements to be so fundamental to
nuclear safety for DOE hazard category 1, 2, and 3 nuclear facilities
that it is essential that these requirements be clearly enforceable
under the PAAA. To properly establish a safety basis for a hazard
category 1, 2, or 3 nuclear facility, a contractor must:
Define the scope of work to be performed,
Identify and analyze the hazards associated with the work,
Categorize the facility consistent with DOE STD-1027,
Prepare a documented safety analysis for the facility, and
Establish the hazard controls upon which the contractor
will rely to ensure adequate protection of workers, the public, and the
environment.
D. Can a Facility Be Divided Into Compartments or ``Segmented'' for the
Purpose of Facility Hazard Categorization?
The purpose of performing a hazard categorization and estimating
the radiological and nonradiological hazardous material inventory is to
understand the possible hazards and their potential interactions and to
determine if they could cause harm to individuals or the environment.
If there are facility features that prevent hazards from one process,
operation, or activity from interacting with those of another,
contractors may be able to address the
[[Page 60300]]
hazards separately. Therefore, in certain limited circumstances,
contractors may be able to segment facilities (divide one facility into
two or more facilities), provided the radiological or nonradiological
hazardous materials in one segment cannot interact with radiological or
nonradiological hazardous materials in other segments. If a contractor
chooses to segment a facility, the burden of proof of the independence
of the segments and the adequacy of the treatment of the hazards lies
with the contractor.
The safety basis for each segmented facility must demonstrate that
the hazards cannot interact with radiological or nonradiological
hazardous materials in other segments of the physical structure. For
example, if a fire causes the release of hazardous materials in one
segment, it must be demonstrated that the materials are confined in
that segment by the hazard controls or physical barriers that are not
degraded by the fire. If the hazardous materials could be transported
to other segments by common confinement systems or the lack of other
physical barriers, the facility cannot be segmented for purposes of
this rule.
Additional discussion on segmenting nuclear facilities can be found
in DOE-STD-1027.
E. Is the Contractor Required To Incorporate Changes Directed by DOE
Into the Safety Basis?
Yes. As stated in 830.202(c)(1), the contractor must incorporate in
the safety basis for the facility, any changes, conditions, or hazard
controls directed by DOE.
F. How Often Is the Contractor Required To Update the Documented Safety
Analysis?
Each year, the contractor responsible for a DOE hazard category 1,
2, or 3 nuclear facility must update the documented safety analysis to
reflect all changes to the nuclear facility, the hazards, and the work.
The updated documented safety analysis must be submitted to DOE. If
there were no changes to the nuclear facility or its activities or
operations that affected the documented safety analysis over the
previous year, the contractor may instead send DOE a letter confirming
that there were no changes.
Section 830.203, Unreviewed Safety Question Process
G. When Must a Contractor Use a USQ Process To Evaluate if a Situation
Involves a USQ?
Some changes to the nuclear facility can impact the safety basis.
However, it would be overly burdensome for a contractor to obtain DOE
approval before making any changes to DOE hazard category 1, 2, or 3
nuclear facilities. Through the USQ process, contractors responsible
for DOE hazard category 1, 2, or 3 nuclear facilities may make physical
and procedural changes to a nuclear facility without DOE approval,
provided those changes do not implicitly or explicitly affect the
safety basis of the facility. The USQ process is also used to assess
newly discovered situations that might involve a potential inadequacy
of the safety basis.
The USQ process has two-steps. The contractor must first determine
whether a situation involves a USQ. If it does, the contractor must
inform DOE and then perform an evaluation to determine whether the
existing safety basis is adequate to bound the situation.
A contractor responsible for a hazard category 1, 2, or 3 DOE
nuclear facility must use the USQ process for any of the following
situations to determine if a USQ is involved:
A temporary or permanent change in the facility as
described in the existing documented safety analysis,
A temporary or permanent change in the procedures as
described in the existing documented safety analysis,
A test or experiment not described in the existing
documented safety analysis, or
A potential inadequacy of the documented safety analysis
is discovered for which the safety analysis may not be bounding or may
be otherwise inadequate. In this case, the contractor must (1) take
action to place the facility in a safe condition, (2) notify DOE of the
situation, (3) perform a USQ evaluation, and (4) submit the USQ
evaluation to DOE and obtain its approval prior to removing any
operational restrictions previously imposed.
H. What Is an Unreviewed Safety Question (USQ)?
A situation involves a USQ if
the probability of the occurrence or the consequences of
an accident or the malfunction of equipment important to safety
previously evaluated in the facility documented safety analysis could
be increased,
the possibility of an accident or malfunction of a
different type than any evaluated previously in the facility documented
safety analysis could be created, or
a margin of safety could be reduced.
A situation also involves a USQ if there is a potential inadequacy
of the safety analysis.
I. Is the Contractor Required To Obtain DOE Approval of the USQ
Process?
Yes. The contractor responsible for a hazard category 1, 2, or 3
existing DOE nuclear facility is required to submit the USQ process to
DOE for approval by April 10, 2001. Pending DOE approval of the USQ
process, the contractor must continue to use its existing DOE-approved
USQ process. If the existing process already meets the requirements of
this section, the contractor must notify DOE by April 10, 2001 and
request DOE to issue an approval of the existing process. The USQ
process for a hazard category 1, 2, or 3 new DOE nuclear facility must
be submitted for DOE approval in the safety evaluation report issued
pursuant to Sec. 830.207(d) of the rule. In either case, we will notify
the contractor if any changes to the process are required.
J. What Is a USQ Summary and How Often Must a Contractor Submit It to
DOE?
Each year, when the contractor submits its updated documented
safety analysis to DOE, the contractor must also submit a report which
summarizes all situations for which the contractor performed a USQ
determination since the prior submission. The report must summarize the
results of those determinations.
Section 830.204 Documented Safety Analysis
K. Does the Rule Permit the Contractor To Use a Method To Develop the
Documented Safety Analysis That Is Appropriate for the Hazards and the
Work Involved?
Yes, this rule allows contractors to develop the documented safety
analysis by a method that DOE has approved for the particular facility
or activity and is appropriately graded for the work and the hazards.
Contractors may either propose a method to prepare a documented safety
analysis and obtain DOE approval, or use one of the safe harbor methods
established for defined facilities and activities in Table 2 of
Appendix A to Subpart B of Part 830--General Statement of Safety Basis
Policy.
L. What Are ``Safe Harbor'' Methods?
Safe harbor methods are methods which we have already determined to
be acceptable for use. They are standards or methods developed by DOE
or NRC, or defined in regulations promulgated by the Occupational,
Safety and Health Administration (OSHA). The safe harbor methods are
based on many years of
[[Page 60301]]
experience with the types of facilities to which they may be applied.
Contractors who use safe harbor methods in accordance with the
provisions in Table 1 of Appendix A to Subpart B of Part 830--General
Statement of Safety Basis Policy, do not need to obtain DOE approval
prior to preparing a documented safety analysis. They do need to get
DOE approval to use a method other than a safe harbor method. Whether
or not a contractor uses a safe harbor method to develop its documented
safety analysis, the final documented safety analysis must be submitted
to DOE for approval in accordance with the schedule contained in the
rule. Because the safe harbor methods are already approved by DOE, use
of these methods will streamline the safety basis process by reducing
the amount of review that DOE will need to do. Most DOE contractors are
familiar with DOE standards and NRC regulatory guides relating to the
development of documented safety analyses that are in the form of a
safety analysis report or a BIO. Safe Harbor methods listed in Table 1
of Appendix A to Subpart B of Part 830 include:
NRC Regulatory Guide 1.70, Standard Format and Content of
Safety Analysis Reports for Nuclear Power Plants,
DOE-STD-3009-94, Preparation Guide for U.S. Department of
Energy Nonreactor Nuclear Facility Safety Analysis Reports,
DOE-STD-3011-94, Guidance for Preparation of DOE 5480.22
(TSR) and DOE 5480.23 (SAR) Implementation Plans, and
DOE-STD-3016-99, Hazards Analysis Reports for Nuclear
Explosive Operations.
In addition, the safe harbor provisions in Appendix A to Subpart B
of Part 830 also approve the use of selected provisions in OSHA
regulation 29 CFR 1910.120 (or 29 CFR 1926.65 for construction
activities) in conjunction with the methodology of DOE-STD-1120-98 (or
its successor document) for the preparation of the documented safety
analysis for DOE contractors conducting decommissioning or select
environmental restoration activities of hazard category 1, 2, or 3
nuclear facilities.
The safe harbor methods listed are not the only methods that may be
used. Contractors may propose other methods which they consider to be
more effective. Provided they are approved by DOE, contractor-proposed
methods may be used to prepare the facility safety basis. For example,
the safe harbor method listed for reactors is NRC Regulatory Guide
1.70. That method was developed primarily for power reactors and may be
too onerous for certain types of research reactors. In such cases
contractors should propose an alternate method for DOE approval.
M. What Are the Content Requirements for a Documented Safety Analysis?
The documented safety analysis must:
Describe the facility and the work to be performed;
Identify the hazards associated with the facility;
Evaluate all accident conditions that are presented by
natural and/or manmade hazards;.
Derive the hazard controls, including technical safety
requirements, to eliminate, limit, or mitigate identified hazards, and
define the process for maintaining the hazard controls current at all
times and controlling their use;
Define the characteristics of the safety management
programs necessary to ensure the safe operation of the facility; and
Define necessary criticality safety programs.
Requirements for a documented safety analysis are established in
Section 830.204 and further guidance is available in the documented
safety analysis implementation guide, DOE G 421.X, Implementation Guide
for Use in Developing Documented Safety Analyses to Meet Subpart B of
10 CFR Part 830.
Section 830.205, Technical Safety Requirements
N. Why Is DOE Adding Requirements for Technical Safety Requirements?
The technical safety requirements are the hazard controls that
define the conditions, safe boundaries, and the management or
administrative controls necessary to ensure the safe operation of a
nuclear facility. Technical safety requirements are part of the safety
basis, as are other hazards controls necessary for adequate protection
from all hazards, and are required to be approved by DOE. Contractors
responsible for DOE hazard category 1, 2, and 3 nuclear facilities must
ensure that the technical safety requirements are properly maintained
and updated as operating conditions change or other situations arise
that might not have been analyzed previously.
O. Are Contractors Required To Obtain DOE Approval of the Technical
Safety Requirements?
Yes. Contractors are required to obtain DOE approval of their
technical safety requirements. Section G of the Appendix A to Subpart B
of Part 830 provides additional detail on DOE's expectations for
technical safety requirements. These expectations are consistent with
the criteria for technical safety requirements in DOE Order 5480.22
which are generally being implemented by contractors for DOE hazard
category 1, 2, and 3 nuclear facilities.
P. Are Contractors for Environmental Restoration Facilities Who Follow
the Provisions of 29 CFR 1910.120 or 29 CFR 1926.65 Required To Develop
Technical Safety Requirements?
Rather than preparing technical safety requirements, a contractor
for an environmental restoration activity that involves either (1) work
not done within a permanent structure or (2) the decommissioning of a
facility with only low-level residual fixed radioactivity may follow
the provisions of 29 CFR 1910.120 or 1926.65 to develop its documented
safety analysis and its appropriate hazard controls.
Q. Are Site Personnel Permitted To Take Actions That Do Not Meet the
Technical Safety Requirements?
Site personnel may take emergency actions that depart from a
technical safety requirement in rare circumstances when: (a) no actions
consistent with the technical safety requirement are immediately
apparent and (b) the departure from the technical safety requirements
is needed to protect workers, the public, or the environment from
imminent and significant harm. Such emergency actions must be approved
by a certified operator for a reactor or by a person in authority as
designated in the technical safety requirements for nonreactor nuclear
facilities. Contractors should report any emergency actions that depart
from the technical safety requirements to DOE as soon as practicable in
accordance with an appropriate, existing mechanism as incorporated into
contracts, such as the Occurrence Reporting and Processing System.
Section 830.206, Preliminary Documented Safety Analysis
R. Who Must Prepare a Preliminary Documented Safety Analysis?
To ensure early agreement between DOE and its contractors regarding
what safety design and systems are needed in new nuclear facilities, a
contractor responsible for a new DOE nuclear facility that is hazard
category 1, 2, or 3 must submit a preliminary documented safety
analysis to DOE and obtain DOE approval prior to procuring materials or
components, or beginning
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construction. In addition, a contractor responsible for a major
modification to a hazard category 1, 2, or 3 DOE nuclear facility must
submit a preliminary documented safety analysis to DOE for approval.
The rule does not preclude contractors from using subcontractors to
develop all or part of the preliminary documented safety analysis.
Likewise, in cases where the contractor responsible for the design of,
or modification to, a nuclear facility is not the contractor
responsible for operation of the facility, the design contractor should
generally prepare the preliminary documented safety analysis.
Regardless of which contractor prepares the analysis, however, the
contractor responsible for the nuclear activity is ultimately
responsible for the analysis and must submit it to DOE for review and
approval.
Section 830.207, DOE Approval of Safety Basis
S. By What Date Must a Contractor Submit a Safety Basis That Meets the
Subpart B Requirements of This Rule for DOE Approval?
Contractors for hazard category 1, 2, and 3 existing DOE nuclear
facilities must submit for DOE approval a safety bases that meets the
requirements of Subpart B of this rule by April 10, 2003.
T. Pending DOE Approval of a Safety Basis That Meets This Rule, What
Should a Contractor Do To Continue Operations and Work at a Hazard
Category 1, 2, or 3 Existing Nuclear Facility?
Pending DOE approval of a safety basis that meets this rule, the
contractor responsible for a hazard category 1, 2, or 3 existing DOE
nuclear facility must continue to perform work in accordance with the
safety basis for the facility in effect on October 10, 2000. The
contractor must also maintain the safety basis consistent with the
requirements of this rule pending DOE approval of the new safety basis.
U. What Should a Contractor Do if Its Current DOE-Approved Safety Basis
Does Not Reflect Current Operations or Working Conditions?
If the current safety basis does not reflect current operations,
the contractor should immediately inform DOE and request approval of
any changes to the safety basis that are needed in the interim period
while the safety basis is being upgraded to meet the safety basis
requirements of this rule. It is essential that contractors establish
technical standards, administrative controls, hazard controls, and
other work processes that reflect current operations and meet those
work processes in accordance with the requirements of Subpart A. The
implementation guides that support this rule provide further
information on how contractors should establish interim and upgraded
safety bases.
V. What Should a Contractor Do if It Already Has a DOE-Approved Safety
Basis That Meets the Requirements of the Rule?
If the current, DOE-approved safety basis already meets the
requirements of this Subpart and is consistent with current hazards and
work at the nuclear facility, the contractor must: (1) Notify DOE by
April 9, 2001, (2) document the adequacy of the existing safety basis,
and (3) request DOE to issue a safety evaluation report that approves
the existing safety basis. This is to ensure that both the contractor
and DOE have verified the current safety basis against the requirements
of this rule. If DOE does not issue a safety evaluation report by
October 10, 2001, the contractor should assume that it has not
adequately demonstrated or documented its safety basis against the
requirements of this Subpart. In that case, the contractor should work
with DOE to correct the deficiencies and resubmit the safety basis. In
the interim, the contractor should continue to meet the existing safety
basis in accordance with paragraph 830.207(b).
W. When Must a Contractor Have an Approved Safety Basis for a New DOE
Hazard Category 1, 2, or 3 Nuclear Facility or a Major Modification to
a DOE Hazard Category 1, 2, or 3 Nuclear Facility?
A contractor for a new nuclear facility or a major modification to
a hazard category 1, 2, or 3 DOE nuclear facility must obtain DOE
approval of the safety basis for the nuclear facility before beginning
operation of the nuclear facility or implementing the major
modification.
Safety Management Systems
X. May Contractors Use Safety Bases and Safety Management Programs
Developed Consistent With Its Integrated Safety Management System To
Meet the Rule?
Section 830.204 of the rule requires contractors to define the
characteristics of the safety management programs for a nuclear
facility that are necessary for safe operations. Many DOE contractors
responsible for DOE hazard category 1, 2, or 3 nuclear facilities have
already developed safety management programs to comply with their
contract requirements for Safety Management Systems. There should be no
conflict between the requirements of this rule and the requirements for
Safety Management Systems. Contractors who have developed safety
management programs to meet contract requirements should use these
programs as appropriate to meet the requirements of this rule.
Contractors may incorporate existing programs by reference into the
documented safety analysis provided these programs are sufficient to
provide adequate protection. To aid the review process, they should
also include a copy of any documents that are incorporated by reference
with the documented safety analysis when it is submitted to DOE for
review and approval.
Appendix A to Subpart B of Part 830--General Statement of Safety
Basis Policy
Y. Why Did DOE Include an Appendix to Subpart B of Part 830?
DOE included the Appendix A to Subpart B of Part 830--General
Statement of Safety Basis Policy, to provide information regarding
DOE's expectations and criteria for the safety basis requirements of
Part 830. The appendix does not create any new requirements. The
appendix and the guidance documents referenced therein are intended to
be read and applied consistent with DOE Policy 450.2A, ``Identifying,
Implementing and Complying with Environment, Safety and Health
Requirements'' (May 15, 1996).
IV. Discussion of Other General Topics Pertinent to the Rules
A. What Does DOE Intend To Do With Other DOE Directives That Relate to
Nuclear Safety Management Topics?
We intend to maintain the DOE Quality Assurance Order (DOE O 414.1,
Quality Assurance) so it may be applied through contracts to non-
nuclear facilities. Other directives related to nuclear safety such as
DOE Orders 5480.23 (Nuclear Safety Analysis Reports), 5480.22
(Technical Safety Requirements), and 5480.21 (Unreviewed Safety
Questions) are incorporated in most DOE contracts where nuclear
activities are involved, and work has begun using these orders for
requirements. Those contract requirements are not changed by the
issuance of this rule.
We will retain DOE Orders 5480.23, 5480.22, and 5480.21 during the
transition period for this rule (approximately the next two and a half
[[Page 60303]]
years) while updated safety bases are established. After this
transition period, we will consider canceling DOE Orders 5480.23,
5480.22, and 5480.21 and relying on this rule and its implementing
guides for safety basis requirements. DOE contractors may also work
with DOE to delete these orders from contracts where appropriate. DOE
orders for other nuclear safety management topics such as maintenance,
training, conduct of operations, defect identification, and occurrence
reporting, will be retained so that the applicable and appropriate
requirements of the orders can continue to be referenced in contracts.
B. What if There Is a Conflict Between Contract Requirements and
Technical or Schedule Requirements in This Rule?
As previously noted, we expect the requirements in DOE Orders
414.1, 5480.23, 5480.22, and 5480.21 and other directives related to
nuclear safety that are incorporated in contracts to be compatible with
this rule. To the extent there are any conflicts between this rule and
contract terms and conditions, the provisions of this rule take
precedence. If the rule imposes more stringent requirements than the
contract, the contractor must either meet the requirements in the rule
or obtain an exemption from the rule in accordance with criteria in
Subpart E of 10 CFR Part 820.
A contract or implementing document under a contract may specify
details concerning how contractors will comply with the rule. For
example, a project execution plan or similar project management
planning document may provide for different contractors to design,
construct, and operate a facility. In this regard, DOE may require the
design contractor to prepare the documented safety analysis, and may
require acceptance of the document by the operating contractor.
Also, a contract or implementing document under a contract may
impose additional requirements beyond those imposed by the rule. For
example, on a project specific basis, DOE might require by contract
that a contractor meet a higher level of quality assurance than
reflected in the rule as well as an enhanced USQ process. If a contract
imposes more stringent requirements than imposed by this rule, the
contract requirements would apply unless the contract is modified.
Moreover, the contractor would be expected to develop work processes
that address these contract requirements, and to the extent that these
work processes address nuclear safety activities, they are covered by
the quality assurance provisions of 10 CFR 830.120.
C. What Should Contractors Do if They Have Completed Activities and
Documents To Meet the Above DOE Orders?
We do not expect contractors to significantly modify documents or
commitments already provided to meet similar commitments under
contract. For example, existing documented safety analyses, technical
safety requirements, and processes for USQs that meet the order
requirements should meet the rule requirements. We do not expect
contractors to reduce their commitments to protect health, safety, and
the environment as a result of issuing this rule. If a contractor has
previously submitted documents to meet contract requirements and they
have been approved by DOE, the contractor should assess whether those
documents meet the requirements of Part 830. If they do, the contractor
should send a letter to DOE requesting that DOE extend its approval
under the rule provisions. DOE will inform the contractor if they need
to resubmit the documents for review.
If, on the other hand, a contractor determines that previously
submitted documents do not meet the requirements of this rule, you
should revise your documents to meet the rule requirements and submit
them to DOE for approval. If the changes are minor, you should indicate
what changes have been made to the documents since the DOE approval.
This may help DOE to narrow its review.
D. How Are Nuclear Safety Requirements Imposed on Subcontractors and
Suppliers?
Nuclear safety requirements can be imposed on subcontractors and
suppliers through both regulations and contracts. The definition of
contractor in 10 CFR 820.2 applies to Part 830. That definition
includes ``any person under contract (or its subcontractors or
suppliers) with the Department of Energy.'' This definition includes
those contractors, subcontractors, and suppliers that provide items and
services to DOE nuclear facilities and activities. Therefore,
requirements in Part 830 that are stated to apply to ``contractors''
apply to prime contractors, and can, as appropriate, apply to
subcontractors, and suppliers.
Certain requirements in Part 830 are stated to apply to ``a
contractor responsible for a DOE nuclear facility.'' Such requirements
only apply to prime contractors for DOE nuclear facilities. Regardless
of the performer of the work, the prime contractor bears responsibility
for subcontractor and supplier compliance with appropriate nuclear
safety requirements. DEAR clause 48 CFR 5204-78(d) (the Laws Clause)
requires contractors to flow down necessary provisions in contracts to
subcontractors at any tier to which the contractor determines such
requirements apply. In addition, DEAR 48 CFR 5204-2 (the Integrated
Safety Management Systems clause) states that contractors must include
a clause substantially the same as the Laws Clause in subcontracts
involving complex or hazardous work on the site at a DOE-owned or
leased facility. Other DOE and federal procurement regulations require
contractors to have a DOE-approved contractor purchasing system for
subcontracting.
Many of the requirements that flow down to subcontractors and
suppliers are quality assurance requirements that pertain to procured
items and services. See discussion above in Section II. I. Enforcement
actions may be brought against any subcontractor or supplier who fails
to comply with requirements that are imposed for the performance of
work and provision of items and services that could affect the safety
of a DOE nuclear facility.
E. How Does This Amendment to Part 830 Affect the Positions in Ruling
1995-1?
Ruling 1995-1 interpreted certain provisions of Parts 830 and 835.
61 FR 4209 (Feb. 5, 1996). This interim final rule amends Part 830 in a
manner that changes the interpretations relating to Part 830 in four of
the ten questions presented in Ruling 1995-1. None of the changes
affect the interpretations as they apply to Part 835. Each of the
questions from the Ruling 1995-1 that are affected by this interim
final rule is listed below, as well as the impacts of this amendment.
The positions from Ruling 1995-1 that are not discussed remain
unchanged.
Question 2. Do Parts 830 and 835 apply to government employees in
general and to the Department's government-owned, government-operated
(GOGO) facilities specifically?
Impact of this amendment: This amendment changes Ruling 1995-1 as
it applies to DOE employees and GOGOs. Ruling 1995-1 indicated that
Part 830, unlike Part 835, did not apply to NRC or DOE personnel and to
DOE GOGO facilities. As discussed previously, the scope of Part 830 is
being amended to cover the conduct of DOE personnel. In addition, the
general requirements of Part 830 are being amended to cover GOGO
facilities by providing that if
[[Page 60304]]
there is no contractor for a nuclear facility, DOE must ensure
implementation of the requirements of Part 830.
Question 5. To what extent are activities performed on a DOE site
subject to Parts 830 and 835 if they are regulated by the NRC
(including activities certified by the NRC under section 1701 of the
Atomic Energy Act) or by a State under an agreement with the NRC?
Impact of this amendment: Ruling 1995-1 indicated that Part 830
does not apply to activities that are regulated through a license by
the NRC or under an Agreement with the NRC. This exclusion deals with
the situation where the NRC has issued a license. As discussed
previously, Part 830 is being amended to also exclude activities
conducted under the NWPA. This new exclusion covers activities
conducted under the NWPA for the period prior to the issuance of a
license by the NRC.
Question 6. To what extent are DOE activities performed off a DOE
site subject to Parts 830 and 835, and what is the effect if these
activities are performed on a site regulated by the NRC or by an
Agreement State?
Impact of this amendment: Ruling 1995-1 stated that because Part
830 applies only ``at a DOE nuclear facility,'' Part 830 applies only
at DOE operations and activities and would not apply, for example, at a
supplier's facility. As discussed previously, the scope of Part 830 is
being amended to remove this restrictive language. In particular, the
amended scope governs the conduct of DOE contractors and other persons
conducting activities (including providing items and services) that
affect or may affect the safety of DOE nuclear facilities. The
definition of a nuclear facility is amended to include activities
conducted for or on behalf of DOE to include any related area,
structure, facility, or activity. Furthermore, a nuclear facility is
not limited to a facility located at a DOE site, and the nuclear
facility may be wholly or partially owned or controlled by DOE.
Ruling 1995-1 indicated that Part 830 did not establish a threshold
to exclude coverage of low hazard facilities. That continues to be the
case. However, we have created a threshold for the new safety basis
provisions in Subpart B of Part 830. Specifically, the safety basis
provisions of Subpart B apply only to contractors responsible for
hazard category 1, 2, and 3 nuclear facilities.
The discussion in Ruling 1995-1 relating to activities regulated by
the NRC or an Agreement State is unchanged by this amendment.
Question 10. What is the purpose of the exclusion in Parts 830 and
835 for activities conducted under the Nuclear Explosives and Weapons
Safety program relating to the prevention of accidental or unauthorized
nuclear detonations, and what activities are intended to be included
within the scope of this exclusion?
Impact of this amendment: Ruling 1995-1 indicated that the
exclusion in Part 830 was drafted narrowly to cover only those
activities necessary to prevent an accidental or unauthorized nuclear
detonation. As discussed previously, the amended Part 830 does not
contain this exclusion and, therefore this exclusion and the related
interpretation no longer apply to Part 830. Further, the definition of
nonreactor nuclear facility is amended to clarify that nuclear
explosive hazards are included.
V. Summary and Discussion of Public Comments Received in Response
to the December 9, 1991 and August 31, 1995 Notices of Proposed
Rulemaking for Part 830
Many of the comments received on the 1991 Notice were responded to
in the 1994 Notice, particularly those that related to general topics
or quality assurance. Some of the outstanding issues from the 1991
Notice that were not addressed in the 1994 Notice, as well as
additional issues raised in response to the Reopening Notice, are
addressed below.
General Topics
A. Does the Rule Contain Detailed Criteria or Performance Objectives?
Many of the comments concerning the proposed Part 830 rule focused
on whether the proposed rule should contain the detailed requirements
in the existing DOE nuclear safety orders or performance objectives.
Most of the comments stated that the rule should impose performance
objectives, rather than specific requirements. In general, the
commentors said that we should provide clear direction concerning what
was expected as opposed to how it should be accomplished. However,
there was some disagreement about the level of detail necessary to
provide these clear expectations.
Today we are continuing requirements in Part 830 for quality
assurance and adding requirements for a safety basis. However, in
response to comments on the proposed rule, DOE decided not to include
detailed requirements for training and certification, conduct of
operation, maintenance management, defect identification, and
occurrence reporting which were included as rulemaking topics in the
1991 Notice.
We believe the combination of the safety basis requirements and the
quality assurance requirements, along with contract provisions,
provides sufficient nuclear safety management requirements to address
the hazards at DOE nuclear facilities. Furthermore, rather than
prescribing the method to be used to develop safety basis documents,
the requirements in Subpart B of this rule allow the contractor to
propose the method it intends to use to develop safety basis documents
based upon the work to be performed and the hazards. DOE is responsible
for approving safety basis documents appropriate to the hazards and
facility or activity addressed.
Finally, the enforcement of the safety basis requirements will be
performance-oriented. That is, DOE will focus its enforcement efforts
on whether the contractor operates a nuclear facility and performs work
consistent with its safety basis as approved by DOE.
B. How Do the Requirements of Part 830 Apply to Hazard Category 1, 2,
and 3 Nuclear Facilities and Below Hazard Category 3 Nuclear
Facilities?
We received a number of comments to the question in the Reopening
Notice regarding limiting the application of Part 830 requirements to
either hazard category 1, 2, and 3 nuclear facilities or only hazard
category 1 and 2 nuclear facilities. The comments on this issue came
mostly from DOE contractors or subcontractors and were almost equally
divided on whether hazard category 3 nuclear facilities should be
subject to the requirements in Part 830. In addition, those commentors
who recommended limiting the rule to hazard category 1, 2, or 3 nuclear
facilities or to hazard category 1 and 2 nuclear facilities generally
focused their comments on the impacts of the safety basis requirements
(safety analysis reports, technical safety requirements, and USQ) on
low hazard facilities, not the impacts of the quality assurance
requirements.
We have decided to continue to apply the general requirements of
Secs. 830.1 through 830.7 and the quality assurance requirements in
Subpart A to Part 830 to all activities affecting nuclear safety. The
quality assurance requirements apply for all DOE nuclear facilities,
including hazard category 1, 2, and 3 nuclear facilities and below
hazard category 3 nuclear facilities, except as excluded in Sec. 830.2
or exempted in accordance with Subpart E of Part 820. The rule requires
the implementation of
[[Page 60305]]
the quality assurance requirements to be graded so they may be
appropriately applied at all DOE nuclear facilities. Safety basis
requirements only apply to hazard category 1, 2, and 3 nuclear
facilities. Furthermore, DOE has approved a simplified methodology for
establishing a documented safety analysis for a hazard category 3
nuclear facility in Table 2 of Appendix A in recognition of the lesser
hazards.
A number of the comments received to the Reopening Notice
recommended using DOE-STD-1027, Hazard Categorization and Accident
Analysis Techniques for Compliance with DOE Order 5480.23, Nuclear
Safety Analysis Reports, to define hazard categories for nuclear
facilities. We are incorporating a requirement in Sec. 830.202 for
contractors to categorize their nuclear facilities consistent with DOE-
STD-1027. DOE retains responsibility for approving the categorization
as part of the safety basis.
C. How Do These Rules Apply to Transportation Activities?
The definition of nonreactor nuclear facility published in
Sec. 830.3 of the 1994 Notice excluded transportation of radioactive
materials. This exclusion was added to avoid duplication of regulatory
efforts because much of the transportation of radioactive materials
occurs offsite where it is governed and regulated by DOT or NRC
requirements. In the response to comments in the 1994 Notice, we
indicated that we would add specific provisions to the rules to cover
shipments wholly within DOE sites.
We have decided to amend the definition of nonreactor nuclear
facility to delete the exclusion of transportation of radioactive
materials and add new language to Sec. 830.2 to exclude transportation
of radioactive materials regulated by the DOT. This exclusion is more
narrow than the previous exclusion in the definition of nonreactor
nuclear facilities which excluded all transportation activities. We
have determined that the applicable provisions of the Part 830 rules
should apply to transportation activities which are not subject to DOT
regulations.
The exclusion for activities regulated by DOT in Part 830 does not
apply to either (1) non-transportation activities or (2) activities
which do not need to meet the DOT regulations because they are
specifically excluded from the DOT regulations. For example, 49 CFR
173.7(b) is a DOT regulation which excludes certain shipments of
hazardous wastes which are made by or under the direction of DOE or the
Department of Defense relating to national security. Excluding
shipments of hazardous materials which are covered by Paragraph 49 CFR
173.7(b) from Part 830 would result in them being excluded from both
the DOT regulations and the DOE regulations. Thus, the exclusion for
Part 830 only applies to transportation activities that are subject to
DOT requirements.
Some commentors expressed concern that, in cases when the
transportation exclusion does not apply, application of the Part 830
rules to transportation of radioactive materials onsite would require
safety analysis reports to be prepared specifically for the
transportation activities. While contractors may consider treating
these activities as separate from the nuclear facilities and
consequently prepare separate documented safety analyses (such as
safety analysis reports), as well as plans and programs, a more cost
effective way to apply the nuclear requirements to transportation
requirements, and the one supported by the Department, would be to
integrate those activities into existing site or facility analyses and
plans.
D. What Are the Requirements for Nuclear Explosive and Weapons
Activities?
The Reopening Notice indicated that comments received from the 1991
Notice requested that we clarify the exclusion of nuclear explosive and
weapons surety activities from nuclear safety requirements. Then-
proposed Parts 830 and 835 contained identical exclusions for
activities conducted under the Nuclear Explosives and Weapons Surety
program relating to the prevention of accidental or unauthorized
nuclear detonations. This exclusion was drafted narrowly to exempt from
the nuclear safety rules only those activities necessary to prevent an
accidental or unauthorized nuclear detonation that might be in conflict
with the nuclear safety requirements. The reason for this exclusion was
the paramount importance of preventing accidental or unauthorized
nuclear detonations and ensuring that the requirements in Parts 830 and
835 did not conflict with activities necessary to prevent any such
detonation.
We have crafted the requirements of this rule to permit contractors
to use methods to develop their safety basis documents that are based
upon the work to be performed and the relevant hazards. Consequently,
DOE contractors are expected to use methods that do not conflict with
activities necessary to protect individuals from the risk of detonation
or explosion. Nuclear Explosive and Weapons Surety requirements are
established in DOE Orders 452.1A and 452.2A, and they contain both
nuclear and weapons safety requirements. Table 2 in Appendix A to
Subpart B of this rule lists a safe harbor method for nuclear
explosives facilities that has the same performance-based objectives as
the Nuclear Explosive and Weapons Surety program requirements. As
contractors now have the means to ensure there are no conflicts between
weapons safety and nuclear safety, we determined that the weapons
exclusion is no longer necessary and are deleting it from this rule.
The Integrated Weapons Activity Plan (IWAP) governs how and when
the Nuclear Explosive and Weapons Surety requirements will be
implemented. If a deviation or conflict exists between this rule and
the IWAP, the IWAP can be used as a basis for requesting DOE to approve
an exemption from rule requirements or schedules in accordance with
Subpart E of Part 820.
E. Does the Rule Cover DOE Employees and DOE-Operated Facilities?
The Reopening Notice requested comments on the issue of extending
applicability of Part 830 to cover DOE employees and DOE-operated
facilities. Many commentors on this issue generally favored extending
the nuclear safety requirements to DOE employees and DOE-operated
nuclear facilities (referred to as GOGOs) where the facilities and
hazards were comparable to DOE contractor operated nuclear facilities.
The major concern expressed was with regard to application of PAAA
civil penalties. DOE's authority to impose PAAA civil penalties only
applies to indemnified contractors (including their subcontractors and
suppliers), not DOE employees.
We believe that fundamental nuclear safety expectations should be
applied to our GOGOs, as well as contractor-operated activities, and
therefore the requirements of Part 830 should be applied to GOGOs. We
are adding a new paragraph 830.4(d) to the rule to state that where
there is no contractor for a DOE nuclear facility, DOE must ensure
implementation and compliance with the requirements of this Part. This
language is consistent with that in Part 835. It makes clear that where
DOE, rather than a contractor, is responsible for the operation of a
nuclear facility, DOE must ensure that the activities and operations of
that facility meet the requirements of Part 830. However, as the
authority to impose PAAA civil penalties for violations of nuclear
safety requirements is limited to contractors,
[[Page 60306]]
we will not impose PAAA civil penalties on GOGOs.
F. Does the Rule Cover Nonradioactive Hazards?
The Reopening Notice proposed three options regarding the treatment
of nonradioactive hazards in Part 830. Specifically, these were to
address:
Only radioactive hazards at a nuclear facility,
Only radioactive hazards and those hazards which could
cause or exacerbate an accident involving radioactivity or reduce the
level of nuclear safety, or
All substantial hazards at a nuclear facility.
The hazard categorization developed to meet Sec. 830.202(b)(3) must
be based on an inventory of all radioactive and nonradioactive
hazardous materials within a nuclear facility. Further, we expect our
contractors to address all hazards and the controls necessary to
provide adequate protection to the public, workers, and the environment
from these hazards in the documented safety analysis. Currently, a
safety analysis report developed in accordance with DOE-STD-3009 would
address these hazards. However, the AEA does not authorize DOE to issue
civil penalties for violations of requirements not related to nuclear
safety, and Price-Anderson enforcement is limited to violations of
requirements related to nuclear safety. Therefore, we expect to limit
our Price-Anderson enforcement actions to radiological hazards and
those hazards which could cause or exacerbate an accident involving
radioactivity or reduce the level of nuclear safety.
G. Does the Rule Apply to Non-Nuclear Facilities?
In the Reopening Notice, we requested comments on extending Part
830 to non-nuclear DOE facilities. A few commentors noted the advantage
of seamless plans which would allow integrated and coordinated programs
across sites. However, the majority of the comments, strongly
recommended that Part 830 not be expanded to include non-nuclear
facilities. We concluded that Part 830 should not be extended to apply
to facilities or activities that do not affect safe operation of
nuclear facilities. However, we have determined that Part 830 should be
applied to activities which could affect the safe performance of a
nuclear activity whether or not they are performed at a nuclear
facility or on a DOE site.
Contractors are free to include non-nuclear activities together
with nuclear activities within the scope of quality assurance and
safety management programs so that they are integrated and coordinated
on a site-wide basis. In addition, where used, SMS descriptions will
address the proper coordination of nuclear and non-nuclear activities.
However, as we stated in the General Statement of Enforcement Policy in
Part 820 (Appendix A to Part 820) and above, we will only pursue
enforcement actions through the procedures in Part 820 for those
noncompliances which have nuclear safety significance.
H. What Is the Role of Implementation Plans in Part 830?
In the Reopening Notice we requested comments on options to clarify
the role of implementation plans for the Part 830 requirements.
Implementation plans were an option made available for a contractor who
needed a transition period for bringing existing facilities and
activities into compliance with the nuclear safety requirements. One
commentor to the Reopening Notice stated that deleting the requirement
for implementation plans would permit contractors to apply their
resources directly to implementing the nuclear safety programs.
DOE agrees. The regulatory requirements for a QAP were issued over
six years ago. We expect that actions identified in the quality
assurance implementation plans prepared at that time are completed and
the implementation plans are superseded by final DOE-approved QAPs.
We also believe that implementation plans are not needed for safety
basis requirements. Safety basis requirements have been imposed on
contractors responsible for nuclear facilities for many years,
consequently those contractors should be able to submit safety bases
that meet the requirements of Part 830 by April 10, 2003.
We do not expect new contractors to need to prepare implementation
plans. The DOE procurement process allows for ample notification and
time for a new contractor either to accept and implement the existing
nuclear safety documents and programs or to prepare new ones for DOE
approval prior to beginning work. Consequently, the requirement to
develop implementation plans should no longer be necessary, and we are
deleting it from the rule.
I. How Does DOE Plan To Assess Compliance With the Requirements of Part
830?
A number of comments were received on what constitutes compliance
with nuclear safety rules. Based on those comments, we have concluded
that more specificity as to what constitutes compliance would be
useful. In order for a contractor to comply with a nuclear safety rule,
it must fully implement the applicable requirements stated in the rule
or have an approved exemption. Fully implementing the requirements
includes:
Ensuring that plans, programs, and procedures establish
the criteria or define the actions to be taken to meet the requirements
for a facility, activity, or operation, and
Ensuring that actions, operations, and conditions at the
site or facility are consistent with the plans, programs, and
procedures.
Fully implementing the requirements also entails prime contractors
ensuring that appropriate nuclear safety management requirements are
imposed on and implemented by their subcontractors who perform work at
nuclear facilities or suppliers who provide items and services that
affect nuclear safety at these facilities.
J. Does DOE Plan To Issue Guidance Documents and Must Contractors Use
Them?
We will issue guidance documents in the form of implementation
guides and technical standards to help contractors determine what is
needed to meet our expectations when implementing the requirements in
Part 830. Guidance documents provide details about our expectations and
suggest methods that may be used to meet them. DOE Policy 450.2A
describes the role of guidance in implementing requirements. The
primary implementation guides which define DOE's expectations for this
rule are:
DOE G 414.1-1: Implementation Guide for Use with Independent
and Management Assessment Requirements of 10 CFR Part 830.120 and DOE
5700.6C Quality Assurance
DOE G 414.1-2: Quality Assurance Management System Guide for
Use with 10 CFR 830.120 and DOE O 414.1
DOE G 421.X: Implementation Guide for Use in Developing
Documented Safety Analyses to Meet Subpart B of 10 CFR Part 830
DOE G 423.X: Implementation Guide for Use in Developing
Technical Safety Requirements (TSRs)
DOE G 424.X: Implementation Guide for Use in Addressing
Unreviewed Safety Question (USQ) Requirements
Guides DOE G 414.1-1 and DOE G 414.1-2 are final guides already in use.
Guides 421.X, 423.X, and 424.X are being made available for use and
comment concurrent with the
[[Page 60307]]
publication of this rule. All of these guides, as well as DOE Policy
450.2A, are available through the DOE directives web page on http://www.explorer.doe.gov:1776/htmls/directives.html. Comments to Guides
421.X, 423.X, and 424.X may be submitted to Richard Black at the
mailing address or email address provided at the beginning of this
Notice.
K. To Whom in DOE Does a Contractor Submit Documents for DOE Approval?
The rule contains requirements for contractors to obtain approval
from DOE, but does not specify who or what office in DOE will review
and approve these documents. A number of commentors asked us to
identify the specific DOE office or individual to whom documents are to
be submitted or from whom approval is to be obtained. We chose not to
specifically define individuals or offices for DOE responsibilities if
they have the potential to be changed in future reorganizations. DOE M
411.1-1A, DOE Safety Management Functions, Responsibilities, and
Authorities Manual (FRAM), explicitly defines current DOE
responsibilities and authorities related to safety management that are
established by DOE rules or Orders.
VI. Procedural Requirements
A. Review Under the National Environmental Policy Act
We have reviewed this amendment to 10 CFR Part 830 under the
National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. Sec. 4321
et seq.) and the Council on Environmental Quality regulations for
implementing NEPA (40 CFR Part 1500).
Prior to publishing the notice of proposed rulemaking to add Part
830 to Title 10 of the CFR, and under the NEPA procedures then in
existence, we concluded that the potential environmental impacts of
Part 830 would be clearly insignificant. We decided that neither an
environmental impact statement nor an environmental assessment was
required in connection with the promulgation of this rule. Since that
time, we have issued regulations establishing implementing procedures
for complying with NEPA's requirements [See 10 CFR Part 1021]. We have
further considered Part 830 under these regulations. The regulations
include a list of typical classes of actions, referred to as
categorical exclusions, that normally do not require the preparation of
either an environmental impact statement or an environmental
assessment. Part 830 is covered by several categorical exclusions
including, among others, information gathering, data analysis, and
document preparation (A9); training exercises and simulations (B1.2);
routine maintenance activities and custodial services (B1.3); and site
characterization and environmental monitoring (B3.1) [See 10 CFR Part
1021, Appendices A and B to Subpart D].
We have concluded that the amendment to 10 CFR Part 830 does not
represent a major federal action having significant impact on the
environment under NEPA (42 U.S.C. 4321 et seq. (1976)), the Council on
Environmental Quality's regulations (40 CFR Parts 1500-08), and DOE's
implementing regulations (10 CFR Part 1021). Therefore, the amendment
to this rule does not require an environmental impact statement or an
environmental assessment pursuant to NEPA.
B. Review Under Executive Order 12866
This rule is not a ``significant regulatory action'' within the
scope of section 3(f) of the Executive Order 12866, ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993), and no formal
assessment of costs and benefits was performed. DOE contracts already
contain equivalent requirements for the safe management of nuclear
activities to meet the Department's responsibilities under the Atomic
Energy Act to protect workers, members of the public, and the
environment. Thus, DOE concluded that this rulemaking would not result
in any significant additional costs. The public comments submitted in
response to the 1991 Notice of Proposed Rulemaking and the 1995
Reopening Notice, which contained similar requirements, provided no
basis for DOE to change its view of the likely economic impact of a
final rule. Further, we have determined that this rule will not (1)
create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (2) materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights or obligations of recipients thereof; or (3) raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order 12866.
Accordingly, this rule was not subject to review under the Executive
Order by the Office of Information and Regulatory Affairs in the Office
of Management and Budget.
C. Review Under Regulatory Flexibility Act
The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., requires that
a Federal agency prepare a regulatory flexibility analysis for any rule
for which the agency is required to publish a general notice of
proposed rulemaking. The requirement to prepare an analysis does not
apply, however, if the agency certifies that a rule will not have a
significant economic impact on a substantial number of small entities.
5 U.S.C. 605(b). The impact of the changes to Part 830 are primarily
with respect to major contractors. Subcontractors and suppliers are
expected to satisfy the provisions of Part 830 primarily through the
programs and procedures established by prime contractors. Consequently,
the impacts to small entities with respect to changes to Part 830 are
expected to be minor. The economic impact on contractors of this filing
requirement is negligible. On this basis, DOE certifies that the rule
will not have a significant economic impact on a substantial number of
small entities and, therefore, no analysis has been prepared.
D. Review Under the Paperwork Reduction Act of 1995
The information collection provisions of this rule are not
substantially different from those contained in DOE contracts with DOE
prime contractors covered by this rule and were previously approved by
the Office of Management and Budget (OMB) and assigned OMB Control No.
1910-0300. Accordingly, no additional Office of Management and Budget
clearance is required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.) and the procedures implementing that Act, 5 CFR 1320.1 et
seq.
E. Review Under Executive Order 13132
Executive Order 13132 (64 FR 43255, August 10, 1999), requires
agencies to develop an accountable process to ensure meaningful and
timely input by State and local officials in the development of
regulatory policies that have ``federalism implications.'' Policies
that have federalism implications are defined in the Executive Order to
include regulations that have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. DOE has examined the changes to Part 830 and
determined that they do not have a substantial direct effect on the
States, on
[[Page 60308]]
the relationship between the national government and the States, or on
the distribution of power and responsibilities among various levels of
government. No further action is required by Executive Order 13132.
F. Review Under the Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531
et seq., requires each Federal agency, to the extent permitted by law,
to prepare a written assessment of the effects of any Federal mandate
in an agency rule that may result in the expenditure by State, local,
and tribal governments, in the aggregate or by the private sector, of
$100 million or more (adjusted annually for inflation) in any one year.
This rule amends 10 CFR Part 830, and applies only to activities
conducted by or for DOE. Any costs resulting from implementation of
DOE's management, operation, and enforcement of its nuclear safety
program are ultimately borne by the Federal government. Therefore, the
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do
not apply.
G. Review Under Executive Order 12988, Civil Justice Reform
With respect to the review of existing regulations and the
promulgation of new regulations, section 3 of Executive Order 12988,
``Civil Justice Reform,'' 61 FR 4729 (February 7, 1996), imposes on
Executive agencies the general duty to eliminate drafting errors and
ambiguity, write regulations to minimize litigation, provide a clear
legal standard for affected conduct rather than a general standard, and
promote simplification and burden reduction. Section 3(c) of Executive
Order 12988 requires Executive agencies to review regulations in light
of applicable standards in section 3(a) and section 3(b) to determine
whether they are met. DOE has completed the required review and
determined that, to the extent permitted by law, Part 830 meets the
relevant standards of Executive Order 12988.
H. Review Under Small Business Regulatory Enforcement Fairness Act of
1996
As required by 5 U.S.C. 801, DOE will report to Congress on the
promulgation of the rule prior to its effective date. The report will
state that it has been determined that the rule is not a ``major rule''
as defined by 5 U.S.C. 804(3).
List of Subjects in 10 CFR Part 830
DOE contracts, Environment Federal buildings and facilities,
Government contracts, Nuclear energy, Nuclear materials, Nuclear power
plants and reactors, Nuclear safety, Penalties, Public health,
Reporting and recordkeeping requirements, and safety.
Issued in Washington, DC on September 28, 2000.
T. J. Glauthier,
Deputy Secretary of Energy, Department of Energy.
For the reasons set forth in the preamble, Part 830 of chapter III,
title 10, of the Code of Federal Regulations is amended as set forth
below.
PART 830--NUCLEAR SAFETY MANAGEMENT
1. The authority citation for part 830 is revised to read as
follows:
Authority: 42 U.S.C. 2201; 42 U.S.C. 7101 et seq.; and 50 U.S.C.
2401 et seq.
2. Part 830--is revised to read as follows:
PART 830--NUCLEAR SAFETY MANAGEMENT
Sec.
830.1 Scope.
830.2 Exclusions.
830.3 Definitions.
830.4 General requirements.
830.5 Enforcement.
830.6 Recordkeeping.
830.7 Graded approach.
Subpart A--Quality Assurance Requirements
830.120 Scope.
830.121 Quality Assurance Program(QAP).
830.122 Quality assurance criteria.
Subpart B--Safety Basis Requirements
830.200 Scope.
830.201 Performance of work.
830.202 Safety basis.
830.203 Unreviewed safety question process.
830.204 Documented safety analysis.
830.205 Technical safety requirements.
830.206 Preliminary documented safety analysis.
830.207 DOE approval of safety basis.
Appendix A to Subpart B to Part 830--General Statement of Safety
Basis Policy
Sec. 830.1 Scope.
This part governs the conduct of DOE contractors, DOE personnel,
and other persons conducting activities (including providing items and
services) that affect, or may affect, the safety of 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 (Act);
(b) Activities conducted under the authority of the Director, Naval
Nuclear Propulsion, pursuant to Executive Order 12344, as set forth in
Public Law 106-65;
(c) Transportation activities which are regulated by the Department
of Transportation;
(d) Activities conducted under the Nuclear Waste Policy Act of
1982, as amended; and
(e) Activities related to the launch approval and actual launch of
nuclear energy systems into space.
Sec. 830.3 Definitions.
(a) The following definitions apply to this part:
Administrative controls means the provisions relating to
organization and management, procedures, recordkeeping, assessment, and
reporting necessary to ensure safe operation of a facility.
Bases appendix means an appendix that describes the basis of the
limits and other requirements in technical safety requirements.
Critical assembly means special nuclear devices designed and used
to sustain nuclear reactions, which may be subject to frequent core and
lattice configuration change and which frequently may be used as
mockups of reactor configurations.
Criticality means the condition in which a nuclear fission chain
reaction becomes self-sustaining.
Design features means the design features of a nuclear facility
specified in the technical safety requirements that, if altered or
modified, would have a significant effect on safe operation.
Document means recorded information that describes, specifies,
reports, certifies, requires, or provides data or results.
Documented safety analysis means a documented analysis of the
extent to which a nuclear facility can be operated safely with respect
to workers, the public, and the environment, including a description of
the conditions, safe boundaries, and hazard controls that provide the
basis for ensuring safety.
Environmental restoration activities means the process(es) by which
contaminated sites and facilities are identified and characterized and
by which contamination is contained, treated, or removed and disposed.
Existing DOE nuclear facility means a DOE nuclear facility in
operation before April 9, 2001.
Fissionable materials means a nuclide capable of sustaining a
neutron-induced chain reaction (e.g., uranium-233,
[[Page 60309]]
uranium-235, plutonium-238, plutonium-239, plutonium-241, neptunium-
237, americium-241, and curium-244).
Graded approach means the process of ensuring that the level of
analysis, documentation, and actions used 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;
(6) The relative importance of radiological and nonradiological
hazards; and
(7) 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 a
person or damage to a facility or to the environment (without regard to
the likelihood or credibility of accident scenarios or consequence
mitigation).
Hazard controls means measures to eliminate, limit, or mitigate
hazards to workers, the public, or the environment, including
(1) Physical, design, structural, and engineering features;
(2) Safety structures, systems, and components;
(3) Safety management programs;
(4) Technical safety requirements; and
(5) Other controls necessary to provide adequate protection from
hazards.
Item is an all-inclusive term used in place of any of the
following: appurtenance, assembly, component, equipment, material,
module, part, product, structure, subassembly, subsystem, system, unit,
or support systems.
Limiting conditions for operation means the limits that represent
the lowest functional capability or performance level of safety
structures, systems, and components required for safe operations.
Limiting control settings means the settings on safety systems that
control process variables to prevent exceeding a safety limit.
Low-level residual fixed radioactivity means the remaining
radioactivity following reasonable efforts to remove radioactive
systems, components, and stored materials. The remaining radioactivity
is composed of surface contamination that is fixed following chemical
cleaning or some similar process; a component of surface contamination
that can be picked up by smears; or activated materials within
structures. The radioactivity can be characterized as low-level if the
smearable radioactivity is less than the values defined for removable
contamination by 10 CFR Part 835, Appendix D, Surface Contamination
Values, and the hazard analysis results show that no credible accident
scenario or work practices would release the remaining fixed
radioactivity or activation components at levels that would prudently
require the use of active safety systems, structures, or components to
prevent or mitigate a release of radioactive materials.
Major modification means a modification to a DOE nuclear facility
that is completed on or after April 9, 2001 that substantially changes
the existing safety basis for the facility.
New DOE nuclear facility means a DOE nuclear facility that begins
operation on or after April 9, 2001.
Nonreactor nuclear facility means those facilities, activities or
operations that involve, or will involve, radioactive and/or
fissionable materials in such form and quantity that a nuclear or a
nuclear explosive hazard potentially exists to workers, the public, or
the environment, but does not include accelerators and their operations
and does not include activities involving only incidental use and
generation of radioactive materials or radiation such as check and
calibration sources, use of radioactive sources in research and
experimental and analytical laboratory activities, electron
microscopes, and X-ray machines.
Nuclear facility means a reactor or a nonreactor nuclear facility
where an activity is conducted for or on behalf of DOE and includes any
related area, structure, facility, or activity to the extent necessary
to ensure proper implementation of the requirements established by this
Part.
Operating limits means those limits required to ensure the safe
operation of a nuclear facility, including limiting control settings
and limiting conditions for operation.
Preliminary documented safety analysis means documentation prepared
in connection with the design and construction of a new DOE nuclear
facility or a major modification to a DOE nuclear facility that
provides a reasonable basis for the preliminary conclusion that the
nuclear facility can be operated safely through the consideration of
factors such as
(1) The nuclear safety design criteria to be satisfied;
(2) A safety analysis that derives aspects of design that are
necessary to satisfy the nuclear safety design criteria; and
(3) An initial listing of the safety management programs that must
be developed to address operational safety considerations.
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 (QAP) means the overall program or
management system established to assign responsibilities and
authorities, define policies and requirements, and provide for the
performance and assessment of work.
Reactor means any apparatus that is designed or used to sustain
nuclear chain reactions in a controlled manner such as research, test,
and power reactors, and critical and pulsed assemblies and any assembly
that is designed to perform subcritical experiments that could
potentially reach criticality; and, unless modified by words such as
containment, vessel, or core, refers to the entire facility, including
the housing, equipment and associated areas devoted to the operation
and maintenance of one or more reactor cores.
Record means a completed document or other media that provides
objective evidence of an item, service, or process.
Safety basis means the documented safety analysis and hazard
controls that provide reasonable assurance that a DOE nuclear facility
can be operated safely in a manner that adequately protects workers,
the public, and the environment.
Safety class structures, systems, and components means the
structures, systems, or components, including portions of process
systems, whose preventive or mitigative function is necessary to limit
radioactive hazardous material exposure to the public, as identified by
the documented safety analysis.
Safety evaluation report means the report prepared by DOE to
document
(1) The sufficiency of the documented safety analysis for a hazard
category 1, 2, or 3 DOE nuclear facility;
(2) The extent to which a contractor has satisfied the requirements
of Subpart B of this part; and
(3) The basis for approval by DOE of the safety basis for the
facility, including any conditions for approval.
Safety limits means the limits on process variables associated with
those
[[Page 60310]]
safety class physical barriers, generally passive, that are necessary
for the intended facility function and that are required to guard
against the uncontrolled release of radioactive materials.
Safety management program means a program designed to ensure a
facility is operated in a manner that adequately protects workers, the
public, and the environment by covering a topic such as: quality
assurance; maintenance of safety systems; personnel training; conduct
of operations; inadvertent criticality protection; emergency
preparedness; fire protection; waste management; or radiological
protection of workers, the public, and the environment.
Safety management system means an integrated safety management
system established consistent with 48 CFR 970.5204-2.
Safety significant structures, systems, and components means the
structures, systems, and components which are not designated as safety
class structures, systems, and components, but whose preventive or
mitigative function is a major contributor to defense in depth and/or
worker safety as determined from safety analyses.
Safety structures, systems, and components means both safety class
structures, systems, and components and safety significant structures,
systems, and components.
Service means the performance of work, such as design,
manufacturing, construction, fabrication, assembly, decontamination,
environmental restoration, waste management, laboratory sample
analyses, inspection, nondestructive examination/testing, environmental
qualification, equipment qualification, repair, installation, or the
like.
Surveillance requirements means requirements relating to test,
calibration, or inspection to ensure that the necessary operability and
quality of safety structures, systems, and components and their support
systems required for safe operations are maintained, that facility
operation is within safety limits, and that limiting control settings
and limiting conditions for operation are met.
Technical safety requirements (TSRs) means the limits, controls,
and related requirements necessary for the safe operation of a nuclear
facility and, as appropriate for the work and the hazards identified in
the documented safety analysis for the facility, includes safety
limits, operating limits, surveillance requirements, administrative and
management controls, use and application provisions, and design
features, as well as a bases appendix.
Unreviewed Safety Question (USQ) means a situation where
(1) The probability of the occurrence or the consequences of an
accident or the malfunction of equipment important to safety previously
evaluated in the documented safety analysis could be increased;
(2) The possibility of an accident or malfunction of a different
type than any evaluated previously in the documented safety analysis
could be created;
(3) A margin of safety could be reduced; or
(4) The documented safety analysis may not be bounding or may be
otherwise inadequate.
Unreviewed Safety Question process means the mechanism for keeping
a safety basis current by reviewing potential unreviewed safety
questions, reporting unreviewed safety questions to DOE, and obtaining
approval from DOE prior to taking any action that involves an
unreviewed safety question.
Use and application provisions means the basic instructions for
applying technical safety requirements.
(b) Terms defined in the Act or in 10 CFR Part 820 and not defined
in this section of the rule are to be used consistent with the meanings
given in the Act or in 10 CFR Part 820.
Sec. 830.4 General requirements.
(a) No person may take or cause to be taken any action inconsistent
with the requirements of this part.
(b) A contractor responsible for a nuclear facility must ensure
implementation of, and compliance with, the requirements of this part.
(c) The requirements of this part must be implemented in a manner
that provides reasonable assurance of adequate protection of workers,
the public, and the environment from adverse consequences, taking into
account the work to be performed and the associated hazards.
(d) If there is no contractor for a DOE nuclear facility, DOE must
ensure implementation of, and compliance with, the requirements of this
part.
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 10 CFR Part 820.
Sec. 830.6 Recordkeeping.
A contractor must maintain complete and accurate records as
necessary to substantiate compliance with the requirements of this
part.
Sec. 830.7 Graded approach.
Where appropriate, a contractor must use a graded approach to
implement the requirements of this part, document the basis of the
graded approach used, and submit that documentation to DOE.
Subpart A--Quality Assurance Requirements
Sec. 830.120 Scope.
This subpart establishes quality assurance requirements for
contractors conducting activities, including providing items or
services, that affect, or may affect, nuclear safety of DOE nuclear
facilities.
Sec. 830.121 Quality Assurance Program (QAP).
(a) Contractors conducting activities, including providing items or
services, that affect, or may affect, the nuclear safety of DOE nuclear
facilities must conduct work in accordance with the Quality Assurance
criteria in Sec. 830.122.
(b) The contractor responsible for a DOE nuclear facility must:
(1) Submit a QAP to DOE for approval and regard the QAP as approved
90 days after submittal, unless it is approved or rejected by DOE at an
earlier date.
(2) Modify the QAP as directed by DOE.
(3) Annually submit any changes to the DOE-approved QAP to DOE for
approval. Justify in the submittal why the changes continue to satisfy
the quality assurance requirements.
(4) Conduct work in accordance with the QAP.
(c) The QAP must:
(1) Describe how the quality assurance criteria of Sec. 830.122 are
satisfied.
(2) Integrate the quality assurance criteria with the Safety
Management System, or describe how the quality assurance criteria apply
to the Safety Management System.
(3) Use voluntary consensus standards in its development and
implementation, where practicable and consistent with contractual and
regulatory requirements, and identify the standards used.
(4) Describe how the contractor responsible for the nuclear
facility ensures that subcontractors and suppliers satisfy the criteria
of Sec. 830.122.
Sec. 830.122 Quality Assurance Criteria.
The QAP must address the following management, performance, and
assessment criteria:
(a) Criterion 1--Management/Program.
[[Page 60311]]
(1) Establish an organizational structure, functional
responsibilities, levels of authority, and interfaces for those
managing, performing, and assessing the work.
(2) Establish management processes, including planning, scheduling,
and providing resources for the work.
(b) Criterion 2--Management/Personnel Training and Qualification.
(1) Train and qualify personnel to be capable of performing their
assigned work.
(2) Provide continuing training to personnel to maintain their job
proficiency.
(c) Criterion 3--Management/Quality Improvement.
(1) Establish and implement processes to detect and prevent quality
problems.
(2) Identify, control, and correct items, services, and processes
that do not meet established requirements.
(3) Identify the causes of problems and work to prevent recurrence
as a part of correcting the problem.
(4) Review item characteristics, process implementation, and other
quality-related information to identify items, services, and processes
needing improvement.
(d) Criterion 4--Management/Documents and Records.
(1) Prepare, review, approve, issue, use, and revise documents to
prescribe processes, specify requirements, or establish design.
(2) Specify, prepare, review, approve, and maintain records.
(e) Criterion 5--Preformance/Work Processes.
(1) Perform work consistent with technical standards,
administrative controls, and other hazard controls adopted to meet
regulatory or contract requirements, using approved instructions,
procedures, or other appropriate means.
(2) Identify and control items to ensure their proper use.
(3) Maintain items to prevent their damage, loss, or deterioration.
(4) Calibrate and maintain equipment used for process monitoring or
data collection.
(f) Criterion 6--Performance/Design.
(1) Design items and processes using sound engineering/scientific
principles and appropriate standards.
(2) Incorporate applicable requirements and design bases in design
work and design changes.
(3) Identify and control design interfaces.
(4) Verify or validate the adequacy of design products using
individuals or groups other than those who performed the work.
(5) Verify or validate work before approval and implementation of
the design.
(g) Criterion 7--Performance/Procurement.
(1) Procure items and services that meet established requirements
and perform as specified.
(2) Evaluate and select prospective suppliers on the basis of
specified criteria.
(3) Establish and implement processes to ensure that approved
suppliers continue to provide acceptable items and services.
(h) Criterion 8--Performance/Inspection and Acceptance Testing.
(1) Inspect and test specified items, services, and processes using
established acceptance and performance criteria.
(2) Calibrate and maintain equipment used for inspections and
tests.
(i) Criterion 9--Assessment/Management Assessment. Ensure managers
assess their management processes and identify and correct problems
that hinder the organization from achieving its objectives.
(j) Criterion 10--Assessment/Independent Assessment.
(1) Plan and conduct independent assessments to measure item and
service quality, to measure the adequacy of work performance, and to
promote improvement.
(2) Establish sufficient authority, and freedom from line
management, for the group performing independent assessments.
(3) Ensure persons who perform independent assessments are
technically qualified and knowledgeable in the areas to be assessed.
Subpart B--Safety Basis Requirements
Sec. 830.200 Scope.
This Subpart establishes safety basis requirements for hazard
category 1, 2, and 3 DOE nuclear facilities.
Sec. 830.201 Performance of work.
A contractor must perform work in accordance with the safety basis
for a hazard category 1, 2, or 3 DOE nuclear facility and, in
particular, with the hazard controls that ensure adequate protection of
workers, the public, and the environment.
Sec. 830.2021 Safety basis.
(a) The contractor responsible for a hazard category 1, 2, or 3 DOE
nuclear facility must establish and maintain the safety basis for the
facility.
(b) In establishing the safety basis for a hazard category 1, 2, or
3 DOE nuclear facility, the contractor responsible for the facility
must:
(1) Define the scope of the work to be performed;
(2) Identify and analyze the hazards associated with the work;
(3) Categorize the facility consistent with DOE-STD-1027-92
(``Hazard Categorization and Accident Analysis Techniques for
compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,''
Change Notice 1, September 1997);
(4) Prepare a documented safety analysis for the facility; and
(5) Establish the hazard controls upon which the contractor will
rely to ensure adequate protection of workers, the public, and the
environment.
(c) In maintaining the safety basis for a hazard category 1, 2, or
3 DOE nuclear facility, the contractor responsible for the facility
must:
(1) Update the safety basis to keep it current and to reflect
changes in the facility, the work and the hazards as they are analyzed
in the documented safety analysis;
(2) Annually submit to DOE either the updated documented safety
analysis for approval or a letter stating that there have been no
changes in the documented safety analysis since the prior submission;
and
(3) Incorporate in the safety basis any changes, conditions, or
hazard controls directed by DOE.
Sec. 830.203 Unreviewed safety question process.
The contractor responsible for a hazard category 1, 2, or 3 DOE
nuclear facility must:
(a) Submit for DOE approval a USQ process that meets the
requirements of this section:
(1) For an existing DOE nuclear facility, by April 10, 2001.
Pending DOE approval of the USQ process, the contractor must continue
to use its existing, DOE-approved USQ process. If the existing process
already meets the requirements of this section, the contractor must
notify DOE by April 10, 2001 and request that DOE issue an approval of
the existing process; and
(2) For a new DOE nuclear facility, on a schedule that allows DOE
approval in a safety evaluation report issued pursuant to section
207(d) of this Part.
(b) Implement the DOE-approved USQ process in situations where
there is a:
(1) Temporary or permanent change in the facility as described in
the existing documented safety analysis;
(2) Temporary or permanent change in the procedures as described in
the existing documented safety analysis;
(3) Test or experiment not described in the existing documented
safety analysis; or
[[Page 60312]]
(4) Potential inadequacy of the documented safety analysis because
the analysis potentially may not be bounding or may be otherwise
inadequate;
(c) Obtain DOE approval prior to taking any action determined to
involve a USQ;
(d) Annually submit to DOE a summary of the USQ determinations
performed since the prior submission; and
(e) If the contractor discovers or is made aware of a potential
inadequacy of the documented safety analysis:
(1) Take action, as appropriate, to place or maintain the facility
in a safe condition until an evaluation of the safety of the situation
is completed;
(2) Notify DOE of the situation;
(3) Perform a USQ determination and notify DOE promptly of the
results; and
(4) Submit the evaluation of the safety of the situation to DOE
prior to removing any operational restrictions initiated to meet
paragraph (e)(1) of this section.
Sec. 830.204 Documented safety analysis.
(a) The contractor responsible for a hazard category 1, 2, or 3 DOE
nuclear facility must obtain approval from DOE for the methodology used
to prepare the documented safety analysis for the facility unless the
contractor uses a methodology set forth in Table 2 of Appendix A to
this Part.
(b) The documented safety analysis for a hazard category 1, 2, or 3
DOE nuclear facility must, as appropriate for the complexities and
hazards associated with the facility:
(1) Describe the facility (including the design of safety
structures, systems and components) and the work to be performed;
(2) Provide a systematic identification of both natural and man-
made hazards associated with the facility;
(3) Evaluate normal, abnormal, and accident conditions, including
consideration of natural and man-made external events, identification
of energy sources or processes that might contribute to the generation
or uncontrolled release of radioactive and other hazardous materials,
and consideration of the need for analysis of accidents which may be
beyond the design basis of the facility;
(4) Derive the hazard controls necessary to ensure adequate
protection of workers, the public, and the environment, demonstrate the
adequacy of these controls to eliminate, limit, or mitigate identified
hazards, and define the process for maintaining the hazard controls
current at all times and controlling their use;
(5) Define the characteristics of the safety management programs
necessary to ensure the safe operation of the facility, including
(where applicable) quality assurance, procedures, maintenance,
personnel training, conduct of operations, emergency preparedness, fire
protection, waste management, and radiation protection; and
(6) With respect to a nonreactor nuclear facility with fissionable
material in a form and amount sufficient to pose a potential for
criticality, define a criticality safety program that:
(i) Ensures that operations with fissionable material remain
subcritical under all normal and credible abnormal conditions,
(ii) Identifies applicable nuclear criticality safety standards,
and
(iii) Describes how the program meets applicable nuclear
criticality safety standards.
Sec. 830.205 Technical safety requirements.
(a) A contractor responsible for a hazard category 1, 2, or 3 DOE
nuclear facility must:
(1) Develop technical safety requirements that are derived from the
documented safety analysis;
(2) Prior to use, obtain DOE approval of technical safety
requirements and any change to technical safety requirements; and
(3) Notify DOE of any violation of a technical safety requirement.
(b) A contractor may take emergency actions that depart from an
approved technical safety requirement when no actions consistent with
the technical safety requirement are immediately apparent, and when
these actions are needed to protect workers, the public or the
environment from imminent and significant harm. Such actions must be
approved by a certified operator for a reactor or by a person in
authority as designated in the technical safety requirements for
nonreactor nuclear facilities. The contractor must report the emergency
actions to DOE as soon as practicable.
(c) A contractor for an environmental restoration activity may
follow the provisions of 29 CFR 1910.120 or 1926.65 to develop the
appropriate hazard controls [rather than the provisions for technical
safety requirements in paragraph (a) of this section], provided the
activity involves either:
(1) Work not done within a permanent structure, or
(2) The decommissioning of a facility with only low-level residual
fixed radioactivity.
Sec. 830.206 Preliminary documented safety analysis.
The contractor responsible for a hazard category 1, 2, or 3 new DOE
nuclear facility or a major modification to a hazard category 1, 2, or
3 DOE nuclear facility must:
(a) Prepare a preliminary documented safety analysis for the
facility, and
(b) Obtain DOE approval of:
(1) The nuclear safety design criteria to be used in preparing the
preliminary documented safety analysis unless the contractor uses the
design criteria in DOE Order 420.1, Facility Safety; and
(2) The preliminary documented safety analysis before the
contractor can procure materials or components or begin construction;
provided that DOE may authorize the contractor to perform limited
procurement and construction activities without approval of a
preliminary documented safety analysis if DOE determines that the
activities are not detrimental to public health and safety and are in
the best interests of DOE.
Sec. 830.207 DOE approval of safety basis.
(a) By April 10, 2003, a contractor responsible for a hazard
category 1, 2, or 3 existing DOE nuclear facility must submit for DOE
approval a safety basis that meets the requirements of this Subpart.
(b) Pending issuance of a safety evaluation report in which DOE
approves a safety basis for a hazard category 1, 2, or 3 existing DOE
nuclear facility, the contractor responsible for the facility must
continue to perform work in accordance with the safety basis for the
facility in effect on October 10, 2000 and maintain the existing safety
basis consistent with the requirements of this Subpart.
(c) If the safety basis for a hazard category 1, 2, or 3 existing
DOE nuclear facility already meets the requirements of this Subpart and
reflects the current work and hazards associated with the facility, the
contractor responsible for the facility must, by April 9, 2001, notify
DOE, document the adequacy of the existing safety basis and request DOE
to issue a safety evaluation report that approves the existing safety
basis. If DOE does not issue a safety evaluation report by October 10,
2001, the contractor must submit a safety basis pursuant to paragraph
(a) of this section.
(d) With respect to a hazard category 1, 2, or 3 new DOE nuclear
facility or a major modification to a hazard category 1, 2, or 3 DOE
nuclear facility, a contractor may not begin operation of the facility
or modification prior to the issuance of a safety evaluation report in
[[Page 60313]]
which DOE approves the safety basis for the facility or modification.
Appendix A to Subpart B to Part 830--General Statement of Safety
Basis Policy
A. Introduction
This appendix describes DOE's expectations for the safety basis
requirements of 10 CFR Part 830, acceptable methods for implementing
these requirements, and criteria DOE will use to evaluate compliance
with these requirements. This Appendix does not create any new
requirements and should be used consistently with DOE Policy 450.2A,
``Identifying, Implementing and Complying with Environment, Safety and
Health Requirements'' (May 15, 1996).
B. Purpose
1. The safety basis requirements of Part 830 require the contractor
responsible for a DOE nuclear facility to analyze the facility, the
work to be performed, and the associated hazards and to identify the
conditions, safe boundaries, and hazard controls necessary to protect
workers, the public and the environment from adverse consequences.
These analyses and hazard controls constitute the safety basis upon
which the contractor and DOE rely to conclude that the facility can be
operated safely. Performing work consistent with the safety basis
provides reasonable assurance of adequate protection of workers, the
public, and the environment.
2. The safety basis requirements are intended to further the
objective of making safety an integral part of how work is performed
throughout the DOE complex. Developing a thorough understanding of a
nuclear facility, the work to be performed, the associated hazards and
the needed hazard controls is essential to integrating safety into
management and work at all levels. Performing work in accordance with
the safety basis for a nuclear facility is the realization of that
objective.
C. Scope
1. A contractor must establish and maintain a safety basis for a
hazard category 1, 2, or 3 DOE nuclear facility because these
facilities have the potential for significant radiological
consequences. DOE-STD-1027-92 (``Hazard Categorization and Accident
Analysis Techniques for compliance with DOE Order 5480.23, Nuclear
Safety Analysis Reports,'' Change Notice 1, September 1997) sets forth
the methodology for categorizing a DOE nuclear facility. The hazard
categorization must be based on an inventory of all radioactive
materials within a nuclear facility.
2. Unlike the quality assurance requirements of Part 830 that apply
to all DOE nuclear and radiological facilities, the safety basis
requirements only apply to hazard category 1, 2, and 3 nuclear
facilities and do not apply to nuclear facilities below hazard category
3.
Table 1
------------------------------------------------------------------------
has the potential for
A DOE nuclear facility categorized as * * * * * *
------------------------------------------------------------------------
hazard category 1............................... significant off-site
consequences.
hazard category 2............................... significant on-site
consequences beyond
localized
consequences.
hazard category 3............................... only local significant
consequences.
below category 3................................ only consequences less
than those that
provide a basis for
categorization as a
hazard category 1, 2,
or nuclear facility.
------------------------------------------------------------------------
D. Integrated Safety Management
1. The safety basis requirements are consistent with integrated
safety management. DOE expects that, if a contractor complies with the
Department of Energy Acquisition Regulation (DEAR) clause on
integration of environment, safety, and health into work planning and
execution (48 CFR 970.5204-2, Integration of Environment, Safety and
Health into Work Planning and Execution) and the DEAR clause on laws,
regulations, and DOE directives (48 CFR 970.5204-78, Laws, Regulations
and DOE Directives), the contractor will have established the
foundation to meet the safety basis requirements.
2. The processes embedded in a safety management system should lead
to a contractor establishing adequate safety bases and safety
management programs that will meet the safety basis requirements of
this Subpart. Consequently, the DOE expects if a contractor has
adequately implemented integrated safety management, few additional
requirements will stem from this Subpart and, in such cases, the
existing safety basis prepared in accordance with integrated safety
management provisions, including existing DOE safety requirements in
contracts, should meet the requirements of this Subpart.
3. DOE does not expect there to be any conflict between contractual
requirements and regulatory requirements. In fact, DOE expects that
contract provisions will be used to provide more detail on
implementation of safety basis requirements such as preparing a
documented safety analysis, developing technical safety requirements,
and implementing a USQ process.
E. Enforcement of Safety Basis Requirements
1. Enforcement of the safety basis requirements will be performance
oriented. That is, DOE will focus its enforcement efforts on whether a
contractor operates a nuclear facility consistent with the safety basis
for the facility and, in particular, whether work is performed in
accordance with the safety basis.
2. As part of the approval process, DOE will review the content and
quality of the safety basis documentation. DOE intends to use the
approval process to assess the adequacy of a safety basis developed by
a contractor to ensure that workers, the public, and the environment
are provided reasonable assurance of adequate protection from
identified hazards. Once approved by DOE, the safety basis
documentation will not be subject to regulatory enforcement actions
unless DOE determines that the information which supports the
documentation is not complete and accurate in all material respects, as
required by 10 CFR 820.11. This is consistent with the DOE enforcement
provisions and policy in 10 CFR Part 820.
3. DOE does not intend the adoption of the safety basis
requirements to affect the existing quality assurance requirements or
the existing obligation of contractors to comply with the quality
assurance requirements. In particular, in conjunction with the adoption
of the safety basis requirements, DOE revised the language
[[Page 60314]]
in 10 CFR 830.122(e)(1) to make clear that hazard controls are part of
the work processes to which a contractor and other persons must adhere
when performing work. This obligation to perform work consistent with
hazard controls adopted to meet regulatory or contract requirements
existed prior to the adoption of the safety basis requirements and is
both consistent with and independent of the safety basis requirements.
4. A documented safety analysis must address all hazards (that is,
both radiological and nonradiological hazards) and the controls
necessary to provide adequate protection to the public, workers, and
the environment from these hazards. Section 234A of the Atomic Energy
Act, however, only authorizes DOE to issue civil penalties for
violations of requirements related to nuclear safety. Therefore, DOE
will impose civil penalties for violations of the safety basis
requirements (including hazard controls) only if they are related to
nuclear safety.
F. Documented Safety Analysis
1. A documented safety analysis must demonstrate the extent to
which a nuclear facility can be operated safely with respect to
workers, the public, and the environment.
2. DOE expects a contractor to use a graded approach to develop a
documented safety analysis and describe how the graded approach was
applied. The level of detail, analysis, and documentation will reflect
the complexity and hazard associated with a particular facility. Thus,
the documented safety analysis for a simple, low hazard facility may be
relatively short and qualitative in nature, while the documented safety
analysis for a complex, high hazard facility may be quite elaborate and
more quantitative. DOE will work with its contractors to ensure a
documented safety analysis is appropriate for the facility for which it
is being developed.
3. Because DOE has ultimate responsibility for the safety of its
facilities, DOE will review each documented safety analysis to
determine whether the rigor and detail of the documented safety
analysis are appropriate for the complexity and hazards expected at the
nuclear facility. In particular, DOE will evaluate the documented
safety analysis by considering the extent to which the documented
safety analysis (1) satisfies the provisions of the methodology used to
prepare the documented safety analysis and (2) adequately addresses the
criteria set forth in 10 CFR 830.204(b). DOE will prepare a Safety
Evaluation Report to document the results of its review of the
documented safety analysis. A documented safety analysis must contain
any conditions or changes required by DOE.
4. In most cases, the contract will provide the framework for
specifying the methodology and schedule for developing a documented
safety analysis. Table 2 sets forth acceptable methodologies for
preparing a documented safety analysis.
Table 2
----------------------------------------------------------------------------------------------------------------
may prepare its documented safety
The contractor responsible for * * * analyses * * *
----------------------------------------------------------------------------------------------------------------
(1) a DOE reactor.......................................................... using the method in U.S. Nuclear
Regulatory Commission Regulatory
Guide 1.70, Standard Format and
Content of Safety Analysis Reports
for Nuclear Power Plants or
successor document.
(2) a DOE nonreactor nuclear facility...................................... using the method in DOE-STD-3009-
94, Preparation Guide for U.S.
Department of Energy Nonreactor
Nuclear Facility Safety Analysis
Reports, July 1994 or successor
document.
(3) a DOE nuclear facility with limited operational life................... using the method in either:
(1) DOE-STD-3009-94 or successor
document or
(2) DOE-STD-3011-94, Guidance for
Preparation of DOE 5480.22 (TSR)
and DOE 5480.23 (SAR)
Implementation Plans, November
1994 or successor document.
(4) the deactivation or the transition surveillance and maintenance of a Using the method in either:
DOE nuclear facility. (1) DOE-STD-3009-94 or successor
document or
(2) DOE-STD-3011-94 or successor
document.
(5) the decommissioning of a DOE nuclear facility.......................... (1) using the method in DOE-STD-
1120-98, May 1998, Integration of
Environment, Safety, and Health
into Facility Disposition
Activities or nuclear successor
document;
(2) using the provisions in 29 CFR
1910.120 (or 29 CFR 1926.65 for
construction activities) for
developing Safety and Health
Programs, Work Plans, Health and
Safety Plans, and Emergency
Response Plans to address public
safety, as well as worker safety;
and
(3) deriving hazard controls based
on the Safety and Health Programs,
the Work Plans, the Health and
Safety Plans, and the Emergency
Response Plans.
(6) a DOE environmental restoration activity that involves either work not (1) using the method in DOE-STD-
done within a permanent structure or the decommissioning of a facility 1120-98 or successor document and
with only low-level residual fixed radioactivity. (2) using the provisions in 29 CFR
1910.120 (or activity that 29 CFR
1926.65 for construction
activities) for developing a
Safety and Health Program and a
site-specific Health and Safety
Plan (including elements for
Emergency Response Plans, conduct
operations, training and
qualifications, and maintenance
management).
(7) a DOE nuclear explosive facility and the nuclear explosive opertions developing its documented safety
conducted therein. analysis in two pieces:
(1) a Safety Analysis Report for
the nuclear facility that
considers the generic nuclear
explosive operations and is
prepared in accordance with DOE-
STD-3009-94 or successor document
and
(2) a Hazard Analysis Report for
the specific nuclear explosive
operations prepared in accordance
with DOE-STD-3016-99, Hazards
Analysis Reports for Nuclear
Explosive Operations, February
1999 or successor document.
(8) a DOE hazard category 3 nonreactor nuclear facility.................... using the methods in Chapters 2, 3,
4, and 5 of DOE-STD-3009-94 or
successor document to address in a
simplified fashion:
(1) the basic description of the
facility/activity and its
operations, including safety
structures, systems, and
components;
(2) a qualitative hazards analysis;
and
(3) the hazard controls (consisting
primarily of inventory limits and
safety management programs) and
their bases.
----------------------------------------------------------------------------------------------------------------
[[Page 60315]]
5. Table 2 refers to specific types of nuclear facilities. These
references are not intended to constitute an exhaustive list of the
specific types of nuclear facilities. Part 830 defines nuclear facility
broadly to include all those facilities, activities, or operations that
involve, or will involve, radioactive and/or fissionable materials in
such form and quantity that a nuclear or a nuclear explosive hazard
potentially exists to the employees or the general public, and to
include any related area, structure, facility, or activity to the
extent necessary to ensure proper implementation of the requirements
established by Part 830. The only exceptions are those facilities
specifically excluded such as accelerators. Table 3 defines the
specific nuclear facilities referenced in Table 2 that are not defined
in 10 CFR 830.3
Table 3
----------------------------------------------------------------------------------------------------------------
For purposes of Table 2, * * * means * * *
----------------------------------------------------------------------------------------------------------------
(1) deactivation........................................................... the process of placing a facility
in a stable and known condition
including the removal of hazardous
and radioactive materials.
(2) decontamination........................................................ the removal or reduction of
residual radioactive and hazardous
materials by mechanical, chemical,
or other techniques to achieve a
stated objective or end condition.
(3) decommissioning........................................................ those actions taking place after
deactivation of a nuclear facility
to retire it from service and
includes surveillance and
maintenance, decontamination, and/
or dismantlement.
(4) environmental restoration activities................................... the process by which contaminated
sites and facilities are
identified and characterized and
by which existing contamination is
contained or removed and disposed.
(5) generic nuclear explosive operation.................................... a characterization that considers
the collective attributes (such as
special facility system
requirements, physical weapon
characteristics, or quantities and
chemical/physical forms of
hazardous materials) for all
projected nuclear explosive
operations to be conducted at a
facility.
(6) nuclear explosive facility............................................. a nuclear facility at which nuclear
operations and activities
involving a nuclear explosive may
be conducted.
(7) nuclear explosive operation............................................ any activity involving a nuclear
explosive, including activities in
which main-charge, high-explosive
parts and pits are collocated.
(8) nuclear facility with a limited operational life....................... a nuclear facility for which there
is a short remaining operational
period before ending the
facility's mission and initiating
deactivation and decommissioning
and for which there are no
intended additional missions other
than cleanup.
(9) specific nuclear explosive operation................................... a specific nuclear explosive
subjected to the stipulated steps
of an individual operation, such
as assembly or disassembly.
(10) transition surveillance and maintenance activities.................... activities conducted when a
facility is not operating or
during deactivation,
decontamination, and
decommissioning operations when
surveillance and maintenance are
the predominant activities being
conducted at the facility. These
activities are necessary for
satisfactory containment of
hazardous materials and protection
of workers, the public, and the
environment. These activities
include providing periodic
inspections, maintenance of
structures, systems, and
components, and actions to prevent
the alteration of hazardous
materials to an unsafe state.
----------------------------------------------------------------------------------------------------------------
6. The contractor responsible for the design and construction of a
new DOE nuclear facility or of a major modification to an existing DOE
nuclear facility must prepare a preliminary documented safety analysis.
A preliminary documented safety analysis can ensure that substantial
costs and time are not wasted in constructing a nuclear facility that
will not be acceptable to DOE. If a contractor is required to prepare a
preliminary documented safety analysis, the contractor must obtain DOE
approval of the preliminary documented safety analysis prior to
procuring materials or components or beginning construction. DOE,
however, may authorize the contractor to perform limited procurement
and construction activities without approval of a preliminary
documented safety analysis if DOE determines that the activities are
not detrimental to public health and safety and are in the best
interests of DOE. DOE Order 420.1, Facility Safety, sets forth
acceptable nuclear safety design criteria for use in preparing a
preliminary documented safety analysis. As a general matter, DOE does
not expect preliminary documented safety analyses to be needed for
activities that do not involve significant construction such as
environmental restoration activities, decontamination and
decommissioning activities, specific nuclear explosive operations, or
transition surveillance and maintenance activities.
G. Hazard Controls
1. Hazard controls are measures to eliminate, limit, or mitigate
hazards to workers, the public, or the environment. They include (1)
physical, design, structural, and engineering features; (2) safety
structures, systems, and components; (3) safety management programs;
(4) technical safety requirements; and (5) other controls necessary to
provide adequate protection from hazards.
2. The types and specific characteristics of the safety management
programs necessary for a DOE nuclear facility will be dependent on the
complexity and hazards associated with the nuclear facility and the
work being performed. In most cases, however, a contractor should
consider safety management programs covering topics such as quality
assurance, procedures, maintenance, personnel training, conduct of
operations, criticality safety, emergency preparedness, fire
protection, waste management, and radiation protection. In general, DOE
Orders set forth DOE's expectations concerning specific topics. For
example, DOE Order 420.1 provides DOE's expectations with respect to
fire protection and criticality safety.
3. Safety structures, systems, and components require formal
definition of minimum acceptable performance in the documented safety
analysis. This is accomplished by first defining a safety function,
then describing the structure, systems, and components, placing
functional requirements on those portions of the structures, systems,
and components required for the safety function, and identifying
performance criteria that will ensure functional
[[Page 60316]]
requirements are met. Technical safety requirements are developed to
ensure the operability of the safety structures, systems, and
components and define actions to be taken if a safety structure,
system, or component is not operable.
4. Technical safety requirements establish limits, controls, and
related requirements necessary for the safe operation of a nuclear
facility. The exact form and contents of technical safety requirements
will depend on the circumstances of a particular nuclear facility as
defined in the documented safety analysis for the nuclear facility. As
appropriate, technical safety requirements may have sections on (1)
safety limits, (2) operating limits, (3) surveillance requirements, (4)
administrative controls, (5) use and application, and (6) design
features. It may also have an appendix on the bases for the limits and
requirements. DOE Guide 423.X, Implementation Guide for Use in
Developing Technical Safety Requirements (TSRs) provides a complete
description of what technical safety requirements should contain and
how they should be developed and maintained.
5. DOE will examine and approve the technical safety requirements
as part of preparing the safety evaluation report and reviewing updates
to the safety basis. As with all hazard controls, technical safety
requirements must be kept current and reflect changes in the facility,
the work and the hazards as they are analyzed in the documented safety
analysis. In addition, DOE expects a contractor to maintain technical
safety requirements, and other hazard controls as appropriate, as
controlled documents with an authorized users list.
6. Table 4 sets forth DOE's expectations concerning acceptable
technical safety requirements.
Table 4
----------------------------------------------------------------------------------------------------------------
As appropriate for a particular DOE nuclear facility, the section of the
technical safety requirements on * * * will provide information on * * *
----------------------------------------------------------------------------------------------------------------
(1) safety limits.......................................................... the limits on process variables
associated with those safety class
physical barriers, generally
passive, that are necessary for
the intended facility function and
that are required to guard against
the uncontrolled release of
radioactive materials.
The safety limit section describes,
as precisely as possible, the
parameters being limited, states
the limit in measurable units
(pressure, temperature, flow,
etc.), and indicates the
applicability of the limit. The
safety limit section also
describes the actions to be taken
in the event that the safety limit
is exceeded. These actions should
first place the facility in the
safe, stable condition attainable,
including total shutdown (except
where such action might reduce the
margin of safety) or should verify
that the facility already is safe
and stable and will remain so. The
technical safety requirement
should state that the contractor
must obtain DOE authorization to
restart the nuclear facility
following a violation of a safety
limit. The safety limit section
also establishes the steps and
time limits to correct the out-of-
specification condition.
(2) operating limits....................................................... those limits which are required to
ensure the safe operation of a
nuclear facility. The operating
limits section may include
subsections on limiting control
settings and limiting conditions
for operation.
(3) limiting control settings.............................................. the settings on safety systems that
control process variables to
prevent exceeding a safety limit.
The limited control settings
section normally contains the
settings for automatic alarms and
for the automatic or nonautomatic
initiation of protective actions
related to those variables
associated with the function of
safety class structures, systems,
or components if the safety
analyses show that they are relied
upon to mitigate or prevent an
accident. The limited control
settings section also identifies
the protective actions to be taken
at the specific settings chosen in
order to correct a situation
automatically or manually such
that the related safety limit is
not exceeded. Protective actions
may include maintaining the
variables within the requirements
and repairing the automatic device
promptly or shutting down the
affected part of the process and,
if required, the entire facility.
(4) limiting conditions for operations..................................... the limits that represent the
lowest functional capability or
performance level of safety
structures, systems, and
components required to perform an
activity safely. The limiting
conditions for operation section
describes, as precisely as
possible, the lowest functional
capability or performance level of
equipment required for continued
safe operation of the facility.
The limiting conditions for
operation section also states the
action to be taken to address a
condition not meeting the limiting
conditions for operation. Normally
this simply provides for the
adverse condition being corrected
in a certain time frame and for
further action if this is
impossible.
(5) surveillance requirements.............................................. requirements relating to test,
calibration, or inspection to
assure that the necessary
operability and quality of safety
structures, systems, and
components is maintained, that
facility operation is within
safety limits, and that limiting
control settings and limiting
conditions for operation are met.
If a required surveillance is not
successfully completed, the
contractor is expected to assume
the systems or components involved
are inoperable and take the
actions defined by the technical
safety requirement until the
systems or components can be shown
to be operable. If, however, a
required surveillance is not
performed within its required
frequency, the contractor is
allowed to perform the
surveillance within 24 hours or
the original frequency, whichever
is smaller, and confirm
operability.
(6) administrative controls................................................ organization and management,
procedures, recordkeeping,
assessment, and reporting
necessary to ensure safe operation
of a facility consistent with the
technical safety requirement. In
general, the administrative
controls section addresses (1) the
requirements associated with
administrative controls,
(including those for reporting
violations of the technical safety
requirement); (2) the staffing
requirements for facility
positions important to safe
conduct of the facility; and (3)
the commitments to the safety
management programs identified in
the documented safety analysis as
necessary components of the safety
basis for the facility.
[[Page 60317]]
(7) use and application provisions......................................... the basic instructions for applying
the safety restrictions contained
in a technical safety requirement.
The use and application section
includes definitions of terms,
operating modes, logical
connectors, completion times, and
frequency notations.
(8) design features........................................................ design features of the facility
that, if altered or modified,
would have a significant effect on
safe operation.
(9) bases appendix......................................................... the reasons for the safety limits,
operating limits, and associated
surveillance requirements in the
technical safety requirements. The
statements for each limit or
requirement shows how the numeric
value, the condition, or the
surveillance fulfills the purpose
derived from the safety
documentation. The primary purpose
for describing the basis of each
limit or requirement is to ensure
that any future changes to the
limit or requirement is done with
full knowledge of the original
intent or purpose of the limit or
requirement.
----------------------------------------------------------------------------------------------------------------
H. Unreviewed Safety Questions
1. The USQ process is an important tool to evaluate whether changes
affect the safety basis. A contractor must use the USQ process to
ensure that the safety basis for a DOE nuclear facility is not
undermined by changes in the facility, the work performed, the
associated hazards, or other factors that support the adequacy of the
safety basis.
2. The USQ process permits a contractor to make physical and
procedural changes to a nuclear facility and to conduct tests and
experiments without prior approval, provided these changes do not cause
a USQ. The USQ process provides a contractor with the flexibility
needed to conduct day-to-day operations by requiring only those changes
and tests with a potential to impact the safety basis (and therefore
the safety of the nuclear facility) be approved by DOE. This allows DOE
to focus its review on those changes significant to safety. The USQ
process helps keeps the safety basis current by ensuring appropriate
review of and response to situations that might adversely affect the
safety basis.
3. DOE Guide 424.X, Implementation Guide for Addressing Unreviewed
Safety Question (USQ) Requirements provides DOE's expectations for a
USQ process. The contractor must obtain DOE approval of any USQ
process.
I. Functions and Responsibilities
1. The DOE Management Official for a DOE nuclear facility (that is,
the Assistant Secretary, the Assistant Administrator, or the Office
Director who is primarily responsible for the management of the
facility) has primary responsibility within DOE for ensuring that the
safety basis for the facility is adequate and complies with the safety
basis requirements of Part 830. The DOE Management Official is
responsible for ensuring the timely and proper (1) review of all safety
basis documents submitted to DOE and (2) preparation of a safety
evaluation report concerning the safety basis for a facility.
2. DOE will maintain a public list on the internet that provides
the status of the safety basis for each hazard category 1, 2, or 3 DOE
nuclear facility and, to the extent practicable, provides information
on how to obtain a copy of the safety basis and related documents for a
facility.
[FR Doc. 00-25453 Filed 10-6-00; 8:45 am]
BILLING CODE 6450-01-P