60292 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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.

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

Mary.Haughey@eh.doe.gov.

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,

richard.black@eh.doe.gov.

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

(§§ 830.1–830.7) and the quality

assurance requirements (§ 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 sitewide 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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 60293

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 § 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 § 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

60294 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

§ 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 § 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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 60295

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 activityspecific 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

60296 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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 § 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 (§ 830.1) relating to items and

services that may affect nuclear safety.

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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 § 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 governmentowned, 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

§ 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

60298 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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

§§ 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 (§ 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 § 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 § 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 § 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 § 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 § 830.122

are met.

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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 § 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 §§ 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 § 830.110, Safety Analysis

Report, § 830.112, Unreviewed Safety

Question Requirements, and § 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

60300 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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 DOEapproved 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 § 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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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

60302 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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, governmentoperated (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

60304 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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 performanceoriented. 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 §§ 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 § 830.2 or exempted in

accordance with Subpart E of Part 820.

The rule requires the implementation of

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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 § 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 § 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 § 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 contractoroperated 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,

60306 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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 § 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 PriceAnderson 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 nonnuclear 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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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. § 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

60308 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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

§ 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.

§ 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.

§ 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,

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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 Xray 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

60310 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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.

§ 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.

§ 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.

§ 830.6 Recordkeeping.

A contractor must maintain complete

and accurate records as necessary to

substantiate compliance with the

requirements of this part.

§ 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

§ 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.

§ 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 § 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 § 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

§ 830.122.

§ 830.122 Quality Assurance Criteria.

The QAP must address the following

management, performance, and

assessment criteria:

(a) Criterion 1—Management/

Program.

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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

§ 830.200 Scope.

This Subpart establishes safety basis

requirements for hazard category 1, 2,

and 3 DOE nuclear facilities.

§ 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.

§ 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.

§ 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

60312 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

(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.

§ 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.

§ 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.

§ 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.

§ 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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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

A DOE nuclear facility categorized

as * * * has the potential for * * *

hazard category 1 ............................ significant off-site consequences.

hazard category 2 ............................ significant on-site consequences beyond localized consequences.

hazard category 3 ............................ only local significant consequences.

below category 3 .............................. only consequences less than those that provide a basis for categorization as a hazard category 1, 2, or

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

60314 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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

The contractor responsible for * * * may prepare its documented safety 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 DOE nuclear facility.

Using the method in either:

(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 done within a permanent structure or the decommissioning of a facility with only low-level residual fixed radioactivity.

(1) using the method in DOE–STD–1120–98 or successor document and

(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 conducted therein.developing its documented safety analysis in two pieces:

(1) a Safety Analysis Report for the nuclear facility that considers the generic nuclear explosive operations and is prepared in accordance with DOE–STD–3009–94 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.

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 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

60316 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations

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.

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 60317

TABLE 4—Continued

As appropriate for a particular DOE nuclear facility, the section of the technical safety requirements on * * *

will provide information on * * *

(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