[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.

[[Page 60297]]

    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

[[Page 60302]]

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