(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, or as approved by DOE at a later date, 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 which DOE approves the safety basis for the facility or modification.
Sec. Appendix A to Subpart B of 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 (see Table 1). 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 facilities (including 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------------------------------------------------------------------------A DOE nuclear facility categorized as *
* * Has the potential for * * *------------------------------------------------------------------------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 3 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 970.5223-1, Integration of Environment, Safety and Health into Work Planning and Execution) and the DEAR clause on laws, regulations, and DOE directives (48 CFR 970.5204-2, 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 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
(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, Change Notice No. 1,
January 2000, 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 a Using the method in either:
(1) DOE-STD-3009-, Change
Notice No. 1, January 2000, 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 Using the method in either:
surveillance and maintenance of a DOE (1) DOE-STD-3009, Change Notice
nuclear facility. No. 1, January 2000, or
successor document, or
(2) DOE-STD-3011-94 or
successor document.(5) The decommissioning of a DOE (1) Using the method in DOE-STD-
nuclear facility. 1120-98, Integration of
Environment, Safety, and
Health into Facility
Disposition Activities, May
1998, or 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 (1) Using the method in DOE-STD-
activity that involves either work not 1120-98 or successor document,
done within a permanent structure or and
the decommissioning of a facility with (2) Using the provisions in 29
only low-level residual fixed CFR 1910.120 (or 29 CFR
radioactivity. 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 of
operations, training and
qualifications, and
maintenance management).(7) A DOE nuclear explosive facility Developing its documented
and the nuclear explosive operations safety 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, Change Notice
No. 1, January 2000, 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 Using the methods in Chapters
nuclear facility. 2, 3, 4, and 5 of DOE-STD-
3009, Change Notice No. 1,
January 2000, 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
(1) Preparing a Safety Analysis
Report for Packaging in
accordance with DOE-O-460.1A,
Packaging and Transportation
Safety, October 2, 1996, or
successor document and
(2) Preparing a Transportation
Safety Document in accordance
with DOE-G-460.1-1,
Implementation Guide for Use
with DOE O 460.1A, Packaging
and Transportation Safety,
June 5, 1997, or successor
document.
(10) Transportation and onsite transfer (1) Preparing a Safety Analysis
of nuclear explosives, nuclear Report for Packaging in
components, Navel nuclear fuel accordance with DOE-O-461.1,
elements, Category I and Category II Packaging and Transportation
special nuclear materials, special of Materials of National
assemblies, and other materials of Security Interest, September
national security. 29, 2000, or successor
document and
(2) Preparing a Transportation
Safety Document in accordance
with DOE-M-461.1-1, Packaging
and Transfer of Materials of
National Security Interest
Manual, September 29, 2000, or
successor document.------------------------------------------------------------------------
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------------------------------------------------------------------------
(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 The process by which
activities. 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 A nuclear facility for which
operational life. 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 A specific nuclear explosive
operation. subjected to the stipulated
steps of an individual
operation, such as assembly or
disassembly(10) Transition surveillance and Activities conducted when a
maintenance activities. 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. If construction begins after December 11, 2000, the contractor responsible for the design and construction of a new DOE nuclear facility or 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 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 actions 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 Will provide information on * * *technical safety requirements
(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 analysis shows 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 The limits that represent the lowest
operations. 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 section. 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.(7) Use and application The basic instructions for applying the
provisions. 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 keep 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 its procedure used to implement the 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.