15180 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 60

RIN 3150–AD51

Disposal of High-Level Radioactive

Wastes in Geologic Repositories;

Design Basis Events

AGENCY: Nuclear Regulatory

Commission.

ACTION: Proposed rule.

SUMMARY: The Nuclear Regulatory

Commission is proposing to amend its

policy on the protection of public health

and safety from activities conducted at

a geologic repository operations area

(GROA) before permanent closure. In

particular, the proposed rule would

address the measures that are required

to provide defense in depth against the

consequences of ‘‘design basis events.’’

These measures include prescribed

design requirements, quality assurance

requirements, and the establishment of

a preclosure controlled area from which

members of the public can be excluded.

DATES: Comments must be submitted on

or before June 20, 1995. Comments

received after this date will be

considered if it is practical to do so, but

the Commission is able to ensure

consideration only for comments

received on or before this date.

ADDRESSES: Send comments to:

Secretary, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. Attention: Docketing and Service

Branch.

Hand-deliver comments to: 11555

Rockville Pike, Rockville, Maryland,

between 7:45 am and 4:15 pm Federal

workdays.

Examine comments received at the

NRC Public Document Room, 2120 L

Street NW (Lower Level), Washington,

DC.

FOR FURTHER INFORMATION CONTACT: Dr.

Richard A. Weller, Division of Waste

Management, Office of Nuclear Material

Safety and Safeguards, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555, telephone (301) 415-7287.

SUPPLEMENTARY INFORMATION:

Background

Under the Nuclear Waste Policy Act

of 1982, as amended, the U.S. Nuclear

Regulatory Commission exercises

licensing and related regulatory

authority with respect to geologic

repositories that are to be constructed

and operated by the U.S. Department of

Energy (DOE) for the disposal of highlevel radioactive waste. The

Commission’s regulations pertaining to

these geologic repositories appear at 10

CFR part 60. In recent years, NRC, in

conjunction with its Federally-Funded

Research and Development Center (the

Center for Nuclear Waste Regulatory

Analyses), completed a comprehensive

review of the requirements of part 60,

regarding their clarity and sufficiency to

protect public health and safety. NRC

focused particular attention on any

matters that may be ambiguous,

insufficient for their intended purpose,

or inconsistent with other expressions

of its regulatory policy. The

amendments presented in this proposed

rule deal with a matter that was brought

to light by this review and by a petition

for rulemaking (PRM) filed by DOE

(PRM–60–3).

The issue concerns the protection of

public health and safety for a broad

range of normal and accident conditions

during the operational period of a

geologic repository (i.e., before

permanent closure). The Commission is

concerned that the current requirements

of part 60 may be unclear and may be

insufficient to protect public health and

safety for the full range of credible

conditions or events that may occur at

an operating repository, including those

low-probability events that have

potentially serious consequences. The

Commission also notes that certain

elements of existing part 60 differ from

counterpart requirements in other NRC

rules, and it believes that greater

consistency in language would be

beneficial. NRC is proposing rulemaking

to address these identified concerns. To

develop and explain the changes to the

regulatory requirements that appear to

be desirable, it would be useful to

review the pertinent provisions of

existing part 60. In this review and in

subsequent discussions in this notice,

unless the specific context suggests

otherwise, the terms ‘‘provisions,’’

‘‘requirements,’’ ‘‘standards,’’ and

‘‘criteria’’ are generally used

interchangeably; the term ‘‘limit’’ (as in

‘‘dose limit’’) is generally used to refer

to a specific type of requirement or

criterion; and the term ‘‘rule’’ is

generally used to refer to the entire set

of requirements or criteria (e.g., part 60).

The Existing Rule

The provisions of part 60 generally

reflect the defense-in-depth philosophy

of the Commission that is commonly

embodied in the requirements and

practices for other types of Commissionregulated facilities, such as commercial

nuclear power reactors and independent

spent fuel storage installations (ISFSIs),

with the overall intent to prevent or

mitigate the occurrence of serious

accidents and, thereby, to protect the

public health and safety. Defense-indepth is provided for, during the

preclosure period, by conservatism,

redundancy, and diversity in design; the

application of a comprehensive quality

assurance program, to facility design,

construction, operation, and

maintenance; the imposition of

radiation protection standards, for both

workers and members of the public, to

limit the potential adverse

consequences of licensed activities to

levels that are well within the bounds

of risks accepted in other productive

activities in society; and requirements

for radiation safety programs and

procedures and emergency plans. The

Commission’s radiation protection

standards are codified in 10 CFR part

20.

Specifically, defense-in-depth is

implemented in Part 60 by repository

performance objectives and by detailed

siting and design criteria. Further, the

rule provides that those structures,

systems, and components determined to

be ‘‘important to safety’’ would be

subject to additional design

requirements and to quality assurance

requirements, to add confidence that the

repository and its subsystems will

perform satisfactorily in service.

However, examination of the specific

provisions of the rule indicates that

some elements may be deficient in

terms of their clarity, sufficiency, or

consistency with other NRC rules,

resulting in concerns about the

adequacy of defense-in-depth in Part 60.

The most significant concerns relate to:

(1) The definition of structures, systems,

and components ‘‘important to safety’’

and the ability to identify such features;

(2) uncertainties in the performance

objective for radiation protection; and

(3) the lack of consistency with 10 CFR

part 72 (‘‘Licensing Requirements for

the Independent Storage of Spent

Nuclear Fuel and High-Level

Radioactive Waste’’) which applies to

‘‘monitored retrievable storage (MRS)

installations,’’ the facilities most similar

to a repository, during the repository’s

operational period. These concerns are

discussed in turn.

‘‘Important-to-Safety’’ Definition

The regulation states (10 CFR 60.2):

‘‘Important to safety,’’ with reference to

structures, systems, and components means

those engineered structures, systems, and

components essential to the prevention or

mitigation of an accident that could result in

a radiation dose to the whole body, or any

organ, of 0.5 rem or greater at or beyond the

nearest boundary of the unrestricted area at

any time until the completion of permanent

closure.
Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15181

Note, first, that the definition refers to

repository features ‘‘essential to the

prevention or mitigation of an accident’’

(emphasis added) in the context of a

dose limit (0.5 rem) ‘‘* * * equal to the

annual dose to the whole body of an

individual in an unrestricted area that

would be permitted under 10 CFR Part

20 for normal operations * * *’’ (48 FR

28202; June 21, 1983, Final rule,

‘‘Disposal of High-Level Radioactive

Wastes in Geologic Repositories’’).

However, the definition is unclear with

respect to the range of ‘‘accidents’’ to be

considered when it is applied to

identify those structures, systems, and

components important to safety. As

such, the uncertainty in the definition

raises questions about the adequacy of

the requirements, in the rule, to protect

the public health and safety for the full

range of conditions or events that may

occur before closure, including those

credible, but unlikely events with

potentially significant radiological

consequences. Second, the focus of the

definition is the protection of members

of the public in unrestricted areas and,

although supplemental design and

quality assurance requirements for this

purpose may also indirectly benefit

onsite workers for some conditions or

events, the definition does not explicitly

address protection for the occupational

workforce. Lastly, the value of 5 mSv

(0.5 rem) as a dose limit in unrestricted

areas for ‘‘accident’’ conditions is

peculiar to part 60, and lacks

consistency with a corresponding limit

in 10 CFR part 72.

Performance Objective for Radiation

Protection

As stated previously, the

Commission’s numerical radiation

protection standards are codified in Part

20. These standards apply to operations

at a geologic repository by virtue of 10

CFR 20.1002 as well as by 10 CFR

60.111(a), which provides, in part:

Protection against radiation exposures and

releases of radioactive material. The geologic

repository operations area shall be designed

so that until permanent closure has been

completed, radiation exposures and radiation

levels, and releases of radioactive materials

to unrestricted areas, will at all times be

maintained within the limits specified in Part

20 of this chapter * * *.

There are two conceptual difficulties

with this language and both issues

derive from the language in the rule that

requires the limits of part 20 to be met

‘‘at all times.’’ The first issue relates to

the uncertainty about the scope of

activities intended in the requirement,

specifically, whether part 20 limits must

be observed not only during planned

operations, but also if the emplaced

waste has to be retrieved in accordance

with 10 CFR 60.111(b). The Commission

previously addressed this issue in a

prior proposed rulemaking, explaining

that the phrase (‘‘at all times’’) was

included in the regulation so as

‘‘* * * to emphasize the need to design

the geologic repository operations area

so that any waste retrieval found to be

necessary in the future could be carried

out in conformance with the radiation

protection requirements of 10 CFR Part

20’’ (51 FR 22288; June 19, 1986,

proposed amendments to conform to

U.S. Environmental Protection Agency

(EPA) general environmental standards).

The Commission adheres to this

interpretation and believes that the

application of part 20 limits to possible

retrieval activities is consistent with the

policy followed in the application of

part 20 to corresponding activities (e.g.,

spent fuel handling) at other facilities

regulated by the Commission under 10

CFR parts 50 and 72 (i.e., at commercial

power reactors and ISFSIs,

respectively).

The second issue relates to

uncertainty about the scope of

conditions intended in § 60.111(a),

specifically, whether part 20 limits must

be observed for the extreme conditions

that may result from credible, but

unlikely, scenarios or events. Here, the

Commission recognizes the desirability

of articulating its intentions more

clearly. For this purpose, it is helpful to

use a simple classification scheme for

describing the broad range of conditions

or events that effectively provide the

design basis for the facility. These socalled ‘‘design basis events’’ are defined

as being of two categories:

(1) those natural and human-induced

events that are reasonably likely to

occur regularly, moderately frequently,

or one or more times before permanent

closure of the geologic repository

operations area; and

(2) other natural and human-induced

events that are considered unlikely, but

sufficiently credible to warrant

consideration, taking into account the

potential for significant radiological

impacts on public health and safety.

Category 1 events have typically been

referred to in the rules and guidance

documents (e.g., regulatory guides) for

Commission-regulated facilities (nuclear

power plants, MRS installations,

geologic repositories) as those

conditions resulting from ‘‘normal

operation, including anticipated

operational occurrences.’’ Anticipated

operational occurrences, including

those of natural origin, are those

conditions expected to occur one or

more times during the lifetime of the

facility.

In the administration of its regulatory

program for facilities licensed under

parts 50 and 72, it has been the

Commission’s general practice, as well

as its intent in part 60, to apply the dose

limits of part 20 to Category 1 events.

The Commission’s intent, in this regard,

is further clarified in the statement of

considerations related to revision of its

part 20 standards (56 FR 23360; May 21,

1991, Final rule, ‘‘Standards for

Protection Against Radiation’’). Here,

the Commission notes that the revision

conforms its regulations to the

‘‘Presidential Radiation Protection

Guidance to Federal Agencies for

Occupational Exposure.’’ The

Commission further notes (56 FR 23365)

that the dose standards in the

Presidential guidance only apply to

normal operating conditions. Although

it is the Commission’s intent that the

regulations in part 20 also be observed

to the extent practicable during

emergencies, the Commission also

recognizes that, in an actual emergency,

operations that do not conform to the

regulations may be necessary to protect

public health and safety.

Notwithstanding the general

applicability of these regulations to all

operational situations, it is not the

Commission’s intent that these

requirements apply to Category 2 events

as a design basis for the facility.

Appropriate requirements other than the

dose limits of part 20 would be

provided as the design basis for

Category 2 events. Some of the

confusion about this matter is no doubt

linked to the terminology used in

various Commission rules or guidance

documents, where the terms

‘‘accidents’’ and ‘‘anticipated

operational occurrences’’ may have been

used interchangeably. It should be

recognized that some accidents’’ may,

indeed, be ‘‘anticipated operational

occurrences,’’ if they are expected to

occur one or more times during the

lifetime of the facility. What is

important, in this regard, is not the term

applied to the event, but its expected

frequency of occurrence, to determine

both its category and whether part 20

limits should apply as a design basis.

Although the foregoing discussion

may help to clarify the Commission’s

intent regarding the applicability of part

20 limits to Categories 1 and 2 design

basis events, it leaves open the question

about the adequacy, to protect public

health and safety, of the requirements of

part 60 for Category 2 events. The

Commission now proposes to address

this matter by harmonizing the

requirements of part 60, as appropriate,

with other parts of its regulations—
15182 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

particularly art 72, which applies to

facilities (MRS installations) with much

in common with repositories, during

their operational period. In this regard,

the character and design of the features

of an MRS installation would be

expected to be very similar to the

surface facilities of an operating

repository. Further, the same kind of

functional activities would be

performed at both types of facilities,

namely, receiving, handling, packaging,

storing, and retrieving high-level

radioactive waste. As such, the

Commission believes that greater

consistency between part 60 and part 72

is both logical and desirable.

10 CFR Part 72

Part 72 also refers to structures,

systems, and components important to

safety. However, instead of defining this

concept in specific quantitative terms, it

provides the following (10 CFR 72.3):

‘‘Structures, systems, and components

important to safety’’ mean those features of

the ISFSI (independent spent fuel storage

installation) or MRS (monitored retrievable

storage installation) whose function is:

(1) to maintain the conditions required to

store spent fuel or high-level radioactive

waste safely;

(2) to prevent damage to the spent fuel or

the high-level radioactive waste container

during handling and storage; or

(3) to provide reasonable assurance that

spent fuel or high-level radioactive waste can

be received, handled, packaged, stored, and

retrieved without undue risk to the health

and safety of the public.

The Commission’s concern in singling

out this class of structures, systems, and

components is to identify those features

that are so important that it is prudent

to warrant the application of special

design and quality assurance criteria.

The design elements that are then to be

required are determined in the light of

the design bases, a term that is defined

as follows:

‘‘Design bases’’ means that information that

identifies the specific functions to be

performed by a structure, system, or

component of a facility and the specific

values or ranges of values chosen for

controlling parameters as reference bounds

for design. These values may be restraints

derived from generally accepted ‘‘state-ofthe-art’’ practices for achieving functional

goals or requirements derived from analysis

(based on calculation or experiments) of the

effects of a postulated event under which a

structure, system, or component must meet

its functional goals. The values for

controlling parameters for external events

include: (1) estimates of severe natural events

to be used for deriving design bases that will

be based on consideration of historical data

on the associated parameters, physical data,

or analysis of upper limits of the physical

processes involved and (2) estimates of

severe external man-induced events to be

used for deriving design bases that will be

based on analysis of human activity in the

region taking into account the site

characteristics and the risks associated with

the event. (10 CFR 72.3.)

Part 72 provides for a quality

assurance program that encompasses a

range of structures, systems, and

components of somewhat indefinite

scope. According to 10 CFR 72.140(b),

the program ‘‘* * * must cover the

activities identified in 10 CFR 72.24(n),’’

which in turn deals with ‘‘structures,

systems, and components important to

safety.’’ The application of these

provisions relates to the qualitative

language of the definition of ‘‘* * *

structures, systems, and components

important to safety.’’ In essence, an

element is to be placed in this category

if its function is to provide reasonable

assurance that there is no undue risk to

the health and safety of the public.

Although the definition lacks specific

numerical guidance as to what

constitutes ‘‘undue risk,’’ the

Commission, nevertheless, regards this

as a stringent test—one that

contemplates that the numerical limits

set out in part 20 will generally be met

for Category 1 design basis events,

consistent with the general practice (as

previously discussed) of the

Commission in the application of these

standards.

With respect to Category 2 design

basis events, numerical guidance may

be inferred from both the ‘‘Siting

Evaluation Factors’’ (Subpart E) and

‘‘General Design Criteria’’ (Subpart F) of

part 72. As specified in 10 CFR 72.106,

for each ISFSI or MRS facility, there

must be a ‘‘controlled area’’ of such size

that no individual located on or beyond

its boundary will receive a dose greater

than 0.05 Sv (5 rem) to the whole body,

or to any organ, from any ‘‘design basis

accident.’’ Both external natural events

and external man-induced events must

be considered in defining the design

bases that would result in the design

basis accident. 10 CFR 72.126(d)

specifies that analyses must be made to

show that releases to the general

environment from design basis

accidents will be within the exposure

limits of 10 CFR 72.106. These

requirements suggest that the 0.05-Sv (5-

rem) dose limit cited above could be

used to aid in the identification of

structures, systems, and components

‘‘important to safety.’’ However,

although the existing functional

definition, in part 72, for ‘‘important-tosafety’’ features, has sufficed for

identifying those corresponding

components or structures of an ISFSI,

the Commission believes that the greater

specificity (i.e., numerical guidance)

provided by a quantitative definition

similar in character to the existing part

60 definition would be more suitable for

the licensing of a more complex

repository.

In the foregoing discussion, the

Commission cited the requirements of

10 CFR 72.106, which include

provisions for the establishment of a

‘‘controlled area’’ boundary and dose

criteria for limiting exposures to

individuals at or beyond that boundary,

during design basis accidents. The

Commission notes that corresponding

requirements are not provided in part 60

which, in turn, raises questions about

the adequacy of the criteria in part 60

to ensure protection of public health

and safety.

There is another matter the

Commission wishes to address, in this

action, that relates to another area of

inconsistency between part 72 and part

60. Subpart F of part 72 provides the

‘‘general design criteria’’ for an ISFSI or

an MRS. These general design criteria

establish the minimum requirements for

the design, fabrication, construction,

testing, maintenance, and performance,

for the structures, systems, and

components of the facility that are

important to safety. In this regard,

subpart F of part 72 is structured

similarly to, and performs the same

function as, appendix A of 10 CFR part

50 (‘‘General Design Criteria for Nuclear

Power Plants’’) in that both sets of

criteria establish minimum

requirements for structures, systems,

and components ‘‘important to safety.’’

The corresponding structure for the

design criteria for the GROA in part 60

is somewhat different from the

corresponding structures in parts 72 and

50.

The design criteria for the GROA are

provided in §§ 60.130 through 60.134

and include criteria for both preclosure

considerations (i.e., criteria for features

‘‘important to safety’’), as well as

postclosure interests (i.e., criteria for

features ‘‘important to waste isolation’’).

However, only the criteria of § 60.131(b)

are identified as ‘‘structures, systems,

and components important to safety,’’

and it is unclear if other criteria

specified in §§ 60.131(a), 60.132, and

60.133, for operational considerations,

are also ‘‘important to safety.’’ In this

regard, the Commission notes that there

are some ‘‘important-to-safety’’ criteria

in part 72 that are not designated as

such, in a corresponding manner, in

part 60. Although the Commission

recognizes that this lack of consistency

may be due, in part, to the dual

interests, in part 60, of preclosure safety

and postclosure isolation, the
Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15183

Commission also believes that this

structure may contribute to the

difficulty in determining which features

of the GROA are ‘‘important to safety’’

and subject to the quality assurance

provisions of subpart G.

The Petition for Rulemaking

On April 19, 1990, DOE filed a PRM

with the Commission. It was assigned

Docket No. PRM–60–3. A notice of

receipt was published in the Federal

Register on July 13, 1990 (55 FR 28771).

In its petition, DOE observed that 10

CFR 60.21(c)(3)(ii) requires that the

safety analysis report for a repository

include a description and analysis that

considers ‘‘* * * the adequacy of

structures, systems, and components

provided for the prevention of accidents

and mitigation of the consequences of

accidents, including those caused by

natural phenomena.’’ Yet, part 60 does

not provide numerical dose criteria (i.e.,

dose limits) to use in identifying the

need for engineered safety features and

for determining their adequacy.

DOE noted how similar operations at

a geologic repository were to those

carried out at other licensed facilities,

including, in particular, facility

operations for independent storage of

spent nuclear fuel. In common with

these other facilities, the operations at a

repository would involve receipt,

handling, transfer, and storage of highly

radioactive materials.

Under DOE’s proposal, part 60 would

be amended to include accident dose

limits of 0.05-Sv (5-rem) effective dose

equivalent or 0.5-Sv (50-rem) committed

dose equivalent to any organ. These

limits would apply to any individual at

the boundary of a newly defined

‘‘preclosure control area.’’ The

definition of the term ‘‘important to

safety’’ would be revised, but would

retain the 5-mSv (0.5-rem) dose limit;

however, unlike the present part 60,

which relates this value to the boundary

of the unrestricted area, DOE’s proposal

would apply the dose limit at the

boundary of the preclosure control area.

The phrase, ‘‘at all times,’’ would be

deleted from 10 CFR 60.111(a), to clarify

that part 20 does not apply to accident

conditions. Lastly, DOE proposed

adding definitions of the terms

‘‘preclosure control area,’’ ‘‘committed

dose equivalent,’’ ‘‘committed effective

dose equivalent,’’ and ‘‘effective dose

equivalent,’’ to support the application

of the accident-dose limits described

above.

For a fuller discussion of the PRM, see

the July 13, 1990, Federal Register

notice.

Discussion

The Commission agrees with the

petitioner that rulemaking is needed to

address the uncertainties related to

appropriate accident-dose limits for

those unlikely, but credible, conditions

or events (i.e., Category 2 design basis

events) that might occur. In this regard,

the Commission agrees with the concept

proposed by DOE, including the

application of appropriate accident-dose

limits at the boundary of a ‘‘preclosure

control area.’’

Regarding the current definition of

‘‘important to safety,’’ the Commission

agrees with DOE that the term should be

revised so as to clarify both its meaning

and its intended scope. Although the

revision proposed by DOE captures the

Commission’s intent, with respect to

identifying those structures, systems,

and components necessary to prevent or

mitigate the consequences of credible,

but unlikely accidents (i.e., Category 2

design basis events), it does not address

the Commission’s parallel interest in

those repository features necessary to

protect workers and members of the

public from those events that occur

regularly, moderately frequently, or one

or more times during the lifetime of the

GROA (i.e., Category 1 design basis

events). The Commission proposes to

address this matter by both expanding

and modifying the current definition in

part 60.

With regard to DOE’s remaining major

item of concern in its petition,

specifically the uncertainty in the

language of 10 CFR 60.111(a), the

Commission agrees with DOE’s proposal

to delete the ambiguous phrase ‘‘at all

times’’ from the rule, to clarify that the

objective does not apply to radiation

exposures, levels, or releases from those

credible, but unlikely conditions or

events that are referred to above as

Category 2 design basis events.

Notwithstanding this change, it remains

the Commission’s intent that this

performance objective applies to all

functional activities (e.g., radioactive

waste receiving, handling, packaging,

storage, and emplacement) expected to

occur at a repository site, including

retrieval, if that becomes necessary.

Finally, with respect to the new

definitions that DOE proposed for 10

CFR 60.2, the Commission agrees that

there is a need to define a boundary for

a ‘‘preclosure control area.’’ However,

the terms ‘‘committed dose equivalent,’’

‘‘committed effective dose equivalent,’’

and ‘‘effective dose equivalent’’ are all

defined terms, in part 20, and

incorporated into part 60 by virtue of 10

CFR 60.111(a). As such, these terms do

not need to be defined in part 60.

Based on the foregoing discussion of

DOE’s petition and the interest of

greater consistency between part 60 and

part 72, as previously discussed, the

Commission proposes to amend part 60

to ensure the adequacy of its

requirements to protect the public

health and safety. In this regard, dose

limits are proposed, in the rule, for

protection of members of the public,

during Category 1 and Category 2 design

basis events, and for protection of

workers, during Category 1 design basis

events. The Commission notes that dose

limits are not proposed for protection of

workers during Category 2 design basis

events, consistent with the policy in

practice for facilities regulated by the

Commission under parts 50 and 72.

The Commission has determined that

specific standards for the protection of

workers during Category 2 events are

not needed for part 60. First, for some

design basis events, the repository

design and quality assurance

enhancements employed to satisfy the

proposed requirements, for protection of

members of the public, during Category

2 events, will also provide a measure of

protection for onsite workers. Second,

onsite workers would have access to

protective equipment (e.g., respirators)

and clothing, should the need ever arise.

Third, onsite workers would be trained

in emergency response and procedures

to deal with operational problems

related to these kinds of events. Fourth,

part 20 should provide adequate worker

protection standards.

There is one other matter the

Commission would like to note in

relation to this action. During the course

of consideration of the DOE PRM and

development of the amendments as

proposed herein, the Commission

identified an additional regulatory

uncertainty with respect to part 60

requirements. Specifically, while part

60 includes a definition for structures,

systems, and components ‘‘important to

safety,’’ there is no corresponding

definition in the rule for structures,

systems, and components ‘‘important to

waste isolation.’’ These definitions are

important as they are the predicates for

required design and quality assurance

requirements in the rule. However, the

focus of the amendments proposed in

this action is strictly in relation to the

adequacy of part 60 requirements to

protect public health and safety during

the operational period of the repository.

Recognizing that the lack of a definition

for ‘‘important to waste isolation’’

relates solely to the period of isolation

following permanent repository closure,

the Commission plans to address this

matter separately in a subsequent

rulemaking action.
15184 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

The proposed amendments are

discussed below.

Section-by-Section Analysis

Section 60.2. Definitions

The proposed amendments involve

eight definitions needed in part 60.

The term ‘‘preclosure controlled area’’

is new. It is essentially the same as the

term ‘‘preclosure control area’’ proposed

by DOE in its petition (PRM–60–3) and

corresponds closely to the term

‘‘controlled area,’’ as defined in 10 CFR

72.3. The term ‘‘preclosure controlled

area’’ is proposed because part 60

already refers to a ‘‘controlled area’’

(within which waste isolation is to be

ensured after permanent closure). The

function of the new term is to delimit

an area over which the licensee

exercises control of activities to meet

regulatory requirements. Control

includes the power to exclude members

of the public, if necessary. Because part

60 (unlike part 72) involves ongoing

underground operations and timeframes

of concern over centuries and millennia,

language in the proposed definition is

included that, consistent with its

function, limits the area to the surface

and limits the duration to the period up

to, and including, permanent closure.

The existing term ‘‘controlled area’’

would be renamed ‘‘postclosure

controlled area,’’ to avoid any confusion

or misunderstanding about this term, in

relation to its use in parts 20 and 72. No

substantive change, however, is

intended for the ‘‘postclosure controlled

area,’’ as this is a change in

nomenclature, only. Consistent with

this change in nomenclature, the term

‘‘controlled area’’ would be changed to

‘‘postclosure controlled area,’’ where it

appears in the definitions for

‘‘accessible environment,’’ ‘‘disturbed

zone,’’ and ‘‘site.’’

The term ‘‘important to safety’’ would

be amended to address the issues

previously discussed. The existing

provision is unclear and fails to ensure

proper levels of protection of public and

worker health and safety for the broad

range of conditions or events that might

occur at a repository site. This is an

important term, because it is the

predicate for required design features, as

well as required quality assurance

measures that provide defense-in-depth.

The Commission proposes to retain the

quantitative features of the existing

definition, but specify different

numerical limits for each of the two

categories (1 and 2) of design basis

events. The structures, systems, and

components ‘‘important to safety’’

would be those necessary: (1) to provide

reasonable assurance that the

requirements of § 60.111(a) would be

observed for Category 1 design basis

events; or (2) to prevent or mitigate

Category 2 design basis events that

could result in doses equal to, or greater

than, the values specified in [new]

§ 60.136, to any individual located on or

beyond the nearest boundary of the

preclosure controlled area.

Although the term ‘‘design bases’’

appears in existing part 60, in 10 CFR

60.21(c)(2), it was not defined. As the

discussion above makes clear, ‘‘design

bases’’ should be understood in relation

to that range of events, including

external natural or man-induced events,

that is taken into account in the design,

and, in particular, in relation to

conditions that could result in

radiological consequences beyond

specified limits. The definition in part

72 would be inserted, without change,

into the list of defined terms in 10 CFR

60.2.

The inclusion of a definition of

‘‘design basis events’’ serves two

purposes. First, it identifies a set of

events (referred to elsewhere as

Category 1 design basis events) that

must be taken into account in

demonstrating compliance with the

requirement to show, with reasonable

assurance, that the provisions of part 20

will be met. (This set of events is

described as ‘‘* * * those natural and

human-induced events that are

reasonably likely to occur regularly,

moderately frequently, or one or more

times before permanent closure of the

geologic repository operations area.’’)

Second, it identifies an additional set of

events (previously referred to as

Category 2 design basis events) that

must be taken into account in applying

the Commission’s defense-in-depth

philosophy. (This set of events is

described as those ‘‘* * * other natural

and human-induced events that are

considered unlikely, but sufficiently

credible to warrant consideration, taking

into account the potential for significant

radiological impacts on public health

and safety.’’) The Commission

recognizes that the criterion of

‘‘sufficiently credible to warrant

consideration’’ is inexact, leaving its

application to a consideration of the

particular site and design that are the

subjects of a license application.

Generally, the Commission would

expect that such design basis events

would include as broad a range of

external phenomena as would be taken

into account in defining the design basis

for other regulated facilities, including

nuclear reactors.

Section 60.8 Information Collection

Requirements: OMB Approval

NRC is proposing to update 10 CFR

60.8, ‘‘Information Collection

Requirements: OMB Approval,’’ to

reflect the fact that subsequent to the

original issuance of part 60, NRC

requested, and obtained Office of

Management and Budget (OMB)

approval for the part 60 ‘‘Information

Collection Requirements.’’ Section 60.8

was to be corrected the first time other

revisions were made.

Section 60.21 Content of Application

The petition for rulemaking suggested

that provision for accident analysis

might be accomplished by amendment

of 10 CFR 60.111. The Commission

proposes, instead, to provide for an

accident analysis as part of the content

of the application section (i.e., 10 CFR

60.21). The proposed language would

require the application to address the

potential dose, to an individual on or

beyond the preclosure controlled area

boundary, that is attributable to

Category 2 design basis events. The

procedure that is envisaged is that the

applicant would address the critical

design basis events, singly, and

demonstrate, by its analysis, that the

doses on or beyond the preclosure

controlled area boundary would be in

accordance with the applicable

requirements. The proposed language

serves the same purpose as the

counterpart section of part 72 (namely

10 CFR 72.24(m)).

The proposed rule also reflects the

position, as discussed previously, that

the applicant must demonstrate that the

requirements of part 20 will be met,

assuming the occurrence of Category 1

design basis events. For this analysis,

the applicant would consider Category 1

design basis events singly, or in

appropriate combinations. The doses,

exposures, or releases must be kept

within part 20 limits should less likely

events (e.g., moderately frequent events)

occur in combination with events that

occur regularly.

The Commission also proposes to

eliminate certain terms in part 60 that

are undefined and may be subject to

differing interpretations—specifically,

the terms ‘‘normal conditions,’’

‘‘anticipated operational occurrences,’’

and ‘‘accidents.’’ These terms would be

supplanted by the new term ‘‘design

basis events.’’ Besides enhancing clarity

of expression, the new language better

reflects the regulatory framework

articulated above. Lastly, where the

term ‘‘controlled area’’ appears in the

language of this section, it would be
Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15185

changed to ‘‘postclosure controlled

area.’’

Section 60.43 License Specification

The term ‘‘controlled area’’ would be

changed to ‘‘postclosure controlled

area.’’

Section 60.46 Particular Activities

Requiring License Amendment

The term ‘‘controlled area’’ would be

changed to ‘‘postclosure controlled

area.’’

Section 60.51 License Amendment for

Permanent Closure

The term ‘‘controlled area’’ would be

changed to ‘‘postclosure controlled

area.’’

Section 60.102 Concepts

The term ‘‘controlled area’’ would be

changed to ‘‘postclosure controlled

area.’’

Section 60.111 Performance of the

Geologic Repository Operations Area

Through Permanent Closure

Consistent with the petitioner’s

proposal, the Commission would delete

the phrase ‘‘at all times’’ from the

performance objective of § 60.111(a).

This change would clarify that this

requirement does not apply to radiation

exposures, levels, and releases from

Category 2 design basis events.

Section 60.121 Requirements for

Ownership and Control of Interests in

Land

The term ‘‘controlled area’’ would be

changed to ‘‘postclosure controlled

area.’’

Section 60.122 Siting Criteria

The term ‘‘controlled area’’ would be

changed to ‘‘postclosure controlled

area.’’

Section 60.130 Scope of Design

Criteria for the Geologic Repository

Operations Area

The Commission proposes to modify

the title of this section to the term

‘‘General Considerations’’ and add

clarifying language, to the existing

discussion, to indicate that §§ 60.131

through 60.134 specify the minimum

criteria for the design of those

structures, systems, and components

important to safety, or important to

waste isolation. These changes are

necessary to provide consistency with

the modified definition of ‘‘important to

safety’’ (10 CFR 60.2) as well as to

clarify the purpose of these criteria.

These changes will also provide

consistency with the corresponding

‘‘minimum’’ design criteria, for an MRS,

in 10 CFR part 72.

Section 60.131 General Design Criteria

for the Geologic Repository Operations

Area

Consistent with the modifications to

§ 60.130, as described above, the

Commission would delete the reference

to ‘‘Structures, systems, and

components important to safety,’’ in the

title of § 60.131(b), and re-letter or renumber the current criteria in

§§ 60.131(b)(1) through 60.131(b)(10), as

appropriate. This change would

eliminate the confusion in the existing

rule related to the identification of only

the criteria in § 60.131(b) as ‘‘important

to safety.’’ It would also resolve the

present incongruity with § 60.131(b)(7),

‘‘Criticality control,’’ regarding the

reference to waste ‘‘isolation’’ (a

postclosure term) in the requirement.

The current rule employs the term

‘‘normal and accident conditions,’’ or

similar expression, in several places.

However, the conditions that must be

addressed under this language are not

well-defined. The Commission proposes

to remedy this situation by replacing

current terminology with references to

‘‘design basis events,’’ thereby ensuring

that the design appropriately takes into

account the consequences of all design

basis events (i.e., as discussed in this

document, Category 1 and 2 design basis

events). Accordingly, modification of

paragraphs (b)(5)(i), (b)(7), and (b)(8) is

being proposed for this section. The

Commission would also revise the

language in 10 CFR 60.131(b)(1), which

refers to ‘‘anticipated’’ natural

phenomena and environmental

conditions, so as to encompass all

design basis events. The ‘‘necessary

safety functions’’ that must be

accommodated in the design, pursuant

to that paragraph, include whatever is

necessary to meet the quantitative limits

set out in the Commission’s rules (i.e.,

in 10 CFR 60.111(a) and 10 CFR 60.136).

Section 60.132 Additional Design

Criteria for Surface Facilities in the

Geologic Repository Operations Area

Section 60.132(c)(1) requires that the

surface facilities must be ‘‘* * *

designed to control the release of

radioactive materials in effluents during

normal operations so as to meet the

performance objectives of § 60.111(a).’’

As indicated previously, the design

should ordinarily be sufficiently

conservative so as to provide reasonable

assurance of meeting part 20 not only

during normal operations, but even for

events that are likely to occur

moderately frequently or one or more

times before permanent closure of the

geologic repository (i.e., all Category 1

design basis events). Deleting the phrase

‘‘during normal operations,’’ as

proposed, will broaden the scope of this

provision to reflect the Commission’s

intent more accurately.

Section 60.133 Additional Design

Criteria for the Underground Facility

As in the case of the changes

proposed to 10 CFR 60.131, a reference

to design basis events would be

substituted for the less precise ‘‘normal

operations and * * * accident

conditions.’’

Section 60.136 Preclosure Controlled

Area.

The proposed rule would adopt the

petitioner’s concept of a preclosure

control area under the name ‘‘preclosure

controlled area.’’ The term would

delimit an area over which the licensee

exercises control of activities to meet

regulatory requirements. Control would

include the power to exclude members

of the public, if necessary. The zone,

and related dose limits, would also be

used to analyze and identify structures,

systems, and components that are

important to safety under unusual

conditions that have heretofore been

characterized as Category 2 design basis

events—credible, yet not likely to occur

during the period of operations. The

issue that is presented concerns the

dose limits on or beyond the preclosure

controlled area boundary that are

appropriate to ensure that the

occurrence of any such events presents

no unreasonable risk to the health and

safety of the public. (Releases resulting

from Category 1 design basis events

would not be permitted to cause doses

exceeding the limits of part 20.) The

Commission proposes to adopt the basic

provisions of part 72—namely, a 0.05-Sv

(5-rem) dose limit, on or beyond the

preclosure controlled area boundary—as

modified to reflect the part 20 system of

dose limits (see § 20.1201(a)). In

addition to providing for separate dose

limits for individual organs and tissue,

the lens of the eye, and the skin, the use

of ‘‘total effective dose equivalent’’

(TEDE) in part 20 explicitly accounts for

exposures via the ingestion and

inhalation dose pathways.

Modification of the 0.05-Sv (5-rem)

dose limit, to reflect the part 20 system

of dose limits, results in a family of dose

limits: a TEDE of 0.05 Sv (5 rem); or the

sum of the deep-dose equivalent and the

committed dose equivalent to any

individual organ or tissue (other than

the lens of the eye) of 0.5 Sv (50 rem);

an eye dose equivalent of 0.15 Sv (15

rem); and a shallow dose equivalent, to
15186 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

1Radiation exposure terminology is as used in

part 20 (56 FR 23360; May 21, 1991).

2NUREG-0800, ‘‘Standard Review Plan for the

Review of Safety Analysis Reports for Nuclear

Power Plants,’’ June 1987.

3National Council on Radiation Protection and

Measurements, ‘‘Risk Estimates for Radiation

Protection,’’ NCRP Report No. 115, December 31,

1993.

4Recommendations of the International

Commission on Radiological Protection. ICRP

Publication 26, January 1977.

5U.S. Department of Energy, ‘‘Site

Characterization Plan, Yucca Mountain Site,

Nevada Research and Development Area, Nevada,’’

DOE/RW-0199, December 1988.

6NUREG-1150, ‘‘Severe Accident Risks: An

Assessment for Five U.S. Nuclear Power Plants,’’

December 1990.

skin, of 0.5 Sv (50 rem).1 The eye and

skin dose limits are adequate to ensure

that no observable effects (e.g.,

induction of cataracts in the lens of the

eye) will occur as a result of any

accidental radiation exposure. In

implementing this provision, dose

calculations should be made solely with

reference to the consequence of the

specific Category 2 design basis event,

and not cumulatively with other design

basis events. To clarify this matter

further, the analysis of a specific

Category 2 design basis event would

require an analysis of an event sequence

or scenario which includes an initiating

event (e.g., an earthquake) and the

associated combinations of repository

system or component failures that can

potentially lead to exposure of the

public to radiation. An example

sequence is a postulated earthquake (the

initiating event) which results in the

failure of a crane lifting a spent fuel

waste package inside a waste handling

building, the drop and breach of the

waste package, damage to the spent fuel

and partitioning of a fraction of the

radionuclide inventory to the building

atmosphere, failure of the building

filtration system, and public exposure to

the released radioactive material.

The only other noteworthy deviation

from part 72 (specifically 10 CFR

72.106) would be to refer to doses

attributable to any ‘‘design basis event’’

instead of any ‘‘design basis accident.’’

The term ‘‘design basis event’’ is used

because it is a defined term in part 60.

The change in terminology is not

intended to be one of substance as a

design basis accident is the consequence

of some design basis event.

As discussed above, the 0.05 Sv (5

rem) dose limit is being proposed by the

Commission as the appropriate design

basis for protection of public health and

safety from Category 2 design basis

events at a GROA and will harmonize

part 60 with part 72. In this regard, the

Commission notes that part 72 applies

to those facilities (MRS installations)

most similar to the surface facilities of

a repository and for which the kinds of

design basis events are also expected to

be similar. Further, the proposed dose

limit is consistent with dose values

(0.06 Sv [6 rem] to the whole body)

established as guidance for both fuelhandling accidents and spent-fuel caskdrop accidents at nuclear power plants.2

Moreover, the proposed dose limit is

consistent with the accident-dose value

(0.05 Sv [5 rem] effective dose

equivalent) proposed by DOE in its

PRM.

However, while consistency between

the proposed 0.05 Sv (5 rem) dose limit

for part 60 and other Commission rules

or guidance documents is important,

consistency alone does not necessarily

ensure that there would be no

unreasonable risk to the health and

safety of the public associated with the

proposed limit. As such, a perspective

is provided on the risks associated with

an operational repository and the

appropriateness of the proposed 0.05 Sv

(5 rem) dose limit as the design basis for

protection of public health and safety

from Category 2 design basis events.

Based on estimates provided by the

National Council on Radiation

Protection and Measurements (NCRP) 3

the lifetime risk to individuals in the

general population is 0.05 fatal cancers

per Seivert (Sv) of exposure. Therefore,

the lifetime risk of fatal cancer from an

assumed 0.05 Sv (5 rem) exposure

resulting from a postulated Category 2

design basis event is 0.0025 (i.e., 2.5 ×

10¥3) per individual exposed. While

this assessment provides perspective on

the risk associated with a hypothetical

exposure of a 0.05 Sv (5 rem) dose, it

does not provide perspective on the

estimated actual risk associated with the

spectrum of possible Category 2 design

basis events at a repository during its

operational lifetime (estimated to be

about 100 years).

Perspective on actual risk must

include consideration of the frequencies

(i.e., probabilities) of occurrence of

these events, as well as their

consequences, as ‘‘risk’’ is defined as

the probability of an event times its

consequences. With respect to the range

of probabilities of Category 2 design

basis events, the upper bound is roughly

1 × 10¥2 per year (i.e., event scenarios

with probabilities of occurrence greater

than 1 × 10¥2 per year would generally

be considered to be Category 1 events)

and the lower bound is considered to be

on the order of 1 × 10¥9 per year (i.e.,

event scenarios with probabilities of

occurrence less than 1 × 10¥9 per year

would generally be screened from

further consideration due to their

negligible contribution to overall risk).

Accordingly, assuming event

consequences equivalent to the

proposed 0.05 Sv (5 rem) dose limit for

part 60, the hypothetical upper bound

on individual risk is 2.5 × 10¥5 fatal

cancers per year. To put this risk in

perspective, the International

Commission on Radiological

Protection 4 notes that, based on a

review of information related to risks

regularly accepted in everyday life for

stochastic phenomena, a fatal cancer

risk in the range of 1 × 10¥6 to 1 × 10¥5

per year from exposure to radiation

would likely be acceptable to individual

members of the public. Thus, while the

risk associated with repository event

consequences at the proposed dose limit

and bounding probability of occurrence

exceeds this range by a small factor, and

is at a level that the Commission

considers safe for occupational

exposures, the Commission believes this

result significantly overestimates the

actual risk of an operating repository.

Perspective on actual repository risk

can be obtained by developing an

understanding of the spectrum of

potential Category 2 design basis events

and estimating the consequences of

these events as well as their

probabilities of occurrence. In this

regard, the Commission recognizes that

there is no high-level waste repository

operating experience and that only

conceptual designs have been

developed for these facilities.

Nonetheless, some perspective can be

gained from the preliminary risk

assessment by DOE 5 of a conceptual

design for a repository at Yucca

Mountain, Nevada, as well as from

consideration of risk assessments of

selected U.S. nuclear power plants.6

Consistent with risk assessments for

nuclear power plants, the spectrum of

possible repository design basis events

includes both internally and externally

initiated events. Internally initiated

events would include waste transporter

collisions, crane failures or other types

of fuel assembly, waste package or cask

drop events, building or facility exhaust

filter fires, and exhaust filter bypass or

failure. Externally initiated events

would include those resulting from

earthquakes, tornados, and flooding.

Regardless of the type or nature of the

initiating event, the Commission

believes that, for several reasons, both

the variety of credible event sequences

and the resulting potential

consequences to members of the public

will be somewhat limited at repository

facilities. First, in comparison with a
Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15187

nuclear power plant, an operating

repository is a relatively simple facility

in which the primary activities are in

relation to waste receipt, handling,

storage, and emplacement. A repository

does not require the variety and

complexity of systems necessary to

support an operating nuclear power

plant. Further, the conditions are not

present at a repository to generate a

radioactive source term of a magnitude

that, however unlikely, is potentially

capable at a nuclear power plant (e.g.,

from a postulated loss of coolant event).

As such, the estimated consequences

resulting from limited source term

generation at a repository would be

correspondingly limited. This

conclusion is consistent with the results

of the aforementioned preliminary risk

assessment by DOE of a conceptual

repository design at Yucca Mountain,

Nevada. In that assessment, the DOE

considered 149 scenarios for a variety of

internally and externally initiated

events. Of the 149 scenarios, only 7

resulted in offsite doses in excess of

0.005 Sv (0.5 rem) to the critical organs

of a maximally exposed individual and

also had associated probabilities of

occurrence greater than 1 × 10¥9 per

year. The highest estimated offsite dose

from the DOE risk assessment was 0.021

Sv (2.1 rem) with an associated

probability of occurrence of 5 × 10¥7

per year.

The dose estimates of the DOE risk

assessment are only reflective of a

conceptual design for a repository at

Yucca Mountain, Nevada. Nonetheless,

the Commission believes they provide

perspective on the magnitude of the

estimated consequences to members of

the public from postulated Category 2

design basis events and that variations

in repository design or site selection

would not likely vary these estimates by

more than order of magnitude. The

results of the DOE risk assessment also

provide some perspective on the

estimated probabilities of occurrence of

the postulated repository design basis

events and, as such, perspective on

actual risk from an operating repository.

In general, the Commission would

expect the potential higher consequence

events to have correspondingly lower

probabilities of occurrence. This

expectation is consistent with the

results of the DOE risk assessment as the

estimated probabilities of occurrence for

the 7 scenarios which resulted in offsite

doses in excess of 0.005 Sv (0.5 rem)

vary from 1 × 10¥9 to 5 × 10¥6 per year.

The corollary to the above is the

expectation that higher frequency events

would have correspondingly lower

offsite consequences and perspective on

actual risk from an operating repository

necessitates consideration of these

events as well as lower frequency

events. Review of the DOE risk

assessment indicates that some higher

frequency, but lower consequence,

events are just as important to actual

risk as the lower frequency, but higher

consequence, events. With respect to

actual risk from the broad spectrum of

all events considered in the DOE risk

assessment, the estimated actual risk of

an operating repository is roughly two

to three orders of magnitude lower than

the range of fatal cancer risks that would

likely be acceptable to members of the

public (i.e., a fatal cancer risk of 1 ×

10¥6 to 1 × 10¥5 per year as noted in

ICRP Publication 26).

With respect to the appropriateness of

the proposed 0.05 Sv (5 rem) dose limit

for part 60 as the design basis for

protection of public health and safety

from Category 2 design basis events, the

DOE risk assessment indicates the

potential for events with offsite

consequences on the order of several

hundredths to several tenths of Sv

(several rem to several tens of rem),

depending on design and siting factors.

The event consequences in this range,

coupled with the estimated event

probabilities of occurrence, result in

estimated risks that would likely be

acceptable to members of the public.

However, given the lack of repository

design, siting and operating experience

and the supporting data base for

probabilistic risk assessment, the

Commission believes there is

considerable uncertainty in the

estimates of both the consequences and

the probabilities of occurrence of

postulated Category 2 design basis

events. As such, the Commission

believes that establishing a dose limit in

part 60 to the proposed 0.05 Sv (5 rem)

value would provide an adequate

margin of safety and an appropriate

design basis for protection of members

of the public from unlikely, but credible

events. Further, the Commission

believes that a singular dose limit is

appropriate for the broad range of

possible event frequencies, given the

limited potential for offsite

consequences at repository facilities and

the significant uncertainties in

repository risk assessment. Stated

differently, the level of sophistication in

repository risk assessment does not

presently exist to warrant a more

complex set of requirements in part 60

for protection of public health and

safety from postulated Category 2 design

basis events. Notwithstanding these

views and the Commission’s parallel

interest in harmonizing part 60 and part

72, the Commission specifically seeks

public comment on (1) the

appropriateness of the proposed 0.05 Sv

(5 rem) dose limit in Section 60.136 as

the design basis for protection of public

health and safety, and (2) the rationale,

as discussed herein, supporting the

proposed 0.05 Sv (5 rem) dose limit.

Section 60.183 Criminal Penalties

A conforming change has been made

to this section, to include § 60.136

(pertaining to the preclosure controlled

area) among the regulations that are not

issued under Sections 161b, 161i, or

161o of the Atomic Energy Act, for

purposes of section 223 of the Act.

Environmental Impact: Categorical

Exclusion

NRC has determined that this

proposed regulation is the type of action

described in 10 CFR 51.22 (c)(2),

pertaining to the promulgation of

technical requirements and criteria that

the Commission will apply in approving

or disapproving applications under part

60. Therefore, neither an environmental

impact statement nor an environmental

assessment has been prepared for this

proposed regulation.

Paperwork Reduction Act Statement

This proposed rule does not contain

a new or amended information

collection requirement subject to the

Paperwork Reduction Act of 1980 (44

U.S.C. 3501, et seq.). Existing

requirements were approved by the

Office of Management and Budget,

approval number 3150–0127.

Regulatory Analysis

The Commission has prepared a draft

regulatory analysis on this proposed

regulation. The analysis examines the

costs and benefits of the alternatives

considered by the Commission. The

draft analysis is available for inspection

in the NRC Public Document Room,

2120 L Street NW. (Lower Level),

Washington, DC. Single copies of the

draft analysis may be obtained from Dr.

Richard A. Weller, U.S. Nuclear

Regulatory Commission, Office of

Nuclear Material Safety and Safeguards,

Division of Waste Management,

Washington, DC 20555, Telephone (301)

415–7287.

Regulatory Flexibility Certification

As required by the Regulatory

Flexibility Act of 1980, 5 U.S.C. 605(b),

the Commission certifies that this rule,

if adopted, will not have a significant

economic impact on a substantial

number of small entities. The only

entity subject to regulation under this

rule is DOE.
15188 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

Backfit Analysis

NRC has determined that the backfit

rule, 10 CFR 50.109, does not apply to

this proposed rule and, therefore, that a

backfit analysis is not required for this

proposed rule, because these

amendments do not involve any

provisions that would impose backfits

as defined in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Part 60

Criminal penalties, High-level waste,

Nuclear power plants and reactors,

Nuclear materials, Reporting and

recordkeeping requirements, and Waste

treatment and disposal.

For the reasons set out in the

preamble and under the authority of the

Atomic Energy Act of 1954, as amended,

the Energy Reorganization Act of 1974,

as amended, the Nuclear Waste Policy

Act of 1982, as amended, and 5 U.S.C.

553, NRC is proposing to adopt the

following amendments to 10 CFR part

60.

PART 60—DISPOSAL OF HIGH-LEVEL

RADIOACTIVE WASTES IN GEOLOGIC

REPOSITORIES

1. The authority citation for part 60

continues to read as follows:

Authority: Secs. 51, 53, 62, 63, 65, 81, 161,

182, 183, 68 Stat. 929, 930, 932, 933, 935,

948, 953, 954, as amended (42 U.S.C. 2071,

2073, 2092, 2093, 2095, 2111, 2201, 2232,

2233); secs. 202, 206, 88 Stat. 1244, 1246 (42

U.S.C. 5842, 5846); secs. 10 and 14, Pub. L.

95–601, 92 Stat. 2951 (42 U.S.C. 2021a and

5851); Sec. 102, Pub. L. 91–190, 83 Stat. 853

(42 U.S.C. 4332); Secs. 114, 121, Pub. L. 97–

425, 96 Stat. 2213g, 2228, as amended (42

U.S.C. 10134, 10141).

2. Section 60.2 is amended by adding

definitions of ‘‘Design bases,’’ ‘‘Design

basis events,’’ and ‘‘Preclosure

controlled area,’’ revising the definitions

of ‘‘Accessible environment,’’

‘‘Disturbed zone,’’ ‘‘Important to safety,’’

and ‘‘Site,’’ renaming the defined term

‘‘Controlled area’’ to ‘‘Postclosure

controlled area,’’ and alphabetizing the

definitions to read as follows:

§ 60.2 Definitions.

* * * * *

Accessible environment means: (1)

The atmosphere, (2) the land surface, (3)

surface water, (4) oceans, and (5) the

portion of the lithosphere that is outside

the postclosure controlled area.

* * * * *

Design bases means that information

that identifies the specific functions to

be performed by a structure, system, or

component of a facility and the specific

values or ranges of values chosen for

controlling parameters as reference

bounds for design. These values may be

restraints derived from generally

accepted ‘‘state-of-the-art’’ practices for

achieving functional goals or

requirements derived from analysis

(based on calculation or experiments) of

the effects of a postulated event under

which a structure, system, or

component must meet its functional

goals. The values for controlling

parameters for external events include:

(1) estimates of severe natural events

to be used for deriving design bases that

will be based on consideration of

historical data on the associated

parameters, physical data, or analysis of

upper limits of the physical processes

involved; and

(2) estimates of severe external maninduced events, to be used for deriving

design bases, that will be based on

analysis of human activity in the region,

taking into account the site

characteristics and the risks associated

with the event.

Design basis events means:

(1) those natural and human-induced

events that are reasonably likely to

occur regularly, moderately frequently,

or one or more times before permanent

closure of the geologic repository

operations area; and

(2) other natural and man-induced

events that are considered unlikely, but

sufficiently credible to warrant

consideration, taking into account the

potential for significant radiological

impacts on public health and safety.

The events described in paragraph (1)

of this definition are referred to as

‘‘Category 1’’ design basis events. The

events described in paragraph (2) of this

definition are referred to as ‘‘Category

2’’ design basis events.

* * * * *

Disturbed zone means that portion of

the postclosure controlled area the

physical or chemical properties of

which have changed as a result of

underground facility construction or as

a result of heat generated by the

emplaced radioactive wastes such that

the resultant change of properties may

have a significant effect on the

performance of the geologic repository.

* * * * *

Important to safety, with reference to

structures, systems, and components,

means those features of the repository

whose function is:

(1) to provide reasonable assurance

that high-level waste can be received,

handled, packaged, stored, emplaced,

and retrieved without exceeding the

requirements of § 60.111(a) for Category

1 design basis events; or

(2) to prevent or mitigate Category 2

design basis events that could result in

doses equal to or greater than the values

specified in § 60.136 to any individual

located on or beyond the nearest

boundary of the preclosure controlled

area.

* * * * *

Postclosure controlled area means a

surface location, to be marked by

suitable monuments, extending

horizontally no more than 10 kilometers

in any direction from the outer

boundary of the underground facility,

and the underlying subsurface, which

area has been committed to use as a

geologic repository and from which

incompatible activities would be

restricted following permanent closure.

* * * * *

Preclosure controlled area means that

surface area immediately surrounding

the geologic repository operations area

for which the licensee exercises

authority over its use, in accordance

with the provisions of this part, until

permanent closure has been completed.

* * * * *

Site means the location of the

postclosure controlled area.

3. Section 60.8 is revised to read as

follows:

§ 60.8 Information collection

requirements: OMB approval.

(a) The Nuclear Regulatory

Commission has submitted the

information collection requirements of

general applicability contained in this

part to the Office of Management and

Budget (OMB) for approval as required

by the Paperwork Reduction Act of 1980

(44 U.S.C. 3501, et seq.). OMB has

approved the information collection

requirements contained in this part

under control number 3150-0127.

(b) The approved information

collection requirements contained in

this part appear in §§ 60.62, 60.63, and

60.65.

4. In § 60.21, paragraphs (c)(1)(i),

(c)(1)(ii)(B), (c)(3), and (c)(8) are revised

to read as follows:

§ 60.21. Content of application.

* * * * *

(c) * * *

(1) * * *

(i) The description of the site shall

also include the following information

regarding subsurface conditions. This

description shall, in all cases, include

such information with respect to the

postclosure controlled area. In addition,

where subsurface conditions outside the

postclosure controlled area may affect

isolation within the postclosure

controlled area, the description shall

include such information with respect

to subsurface conditions outside the

postclosure controlled area to the extent

such information is relevant and
Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules 15189

material. The detailed information

referred to in this paragraph shall

include:

(A) the orientation, distribution,

aperture in-filling and origin of

fractures, discontinuities, and

heterogeneities;

(B) the presence and characteristics of

other potential pathways such as

solution features, breccia pipes, or other

potentially permeable features;

(C) the geomechanical properties and

conditions, including pore pressure and

ambient stress conditions;

(D) the hydrogeologic properties and

conditions;

(E) the geochemical properties; and

(F) the anticipated response of the

geomechanical, hydrogeologic, and

geochemical systems to the maximum

design thermal loading, given the

pattern of fractures and other

discontinuities and the heat transfer

properties of the rock mass and

groundwater.

(ii) * * *

(B) Analyses to determine the degree

to which each of the favorable and

potentially adverse conditions, if

present, has been characterized, and the

extent to which it contributes to or

detracts from isolation. For the purpose

of determining the presence of the

potentially adverse conditions,

investigations shall extend from the

surface to a depth sufficient to

determine critical pathways for

radionuclide migration from the

underground facility to the accessible

environment. Potentially adverse

conditions shall be investigated outside

of the postclosure controlled area if they

affect isolation within the postclosure

controlled area.

* * * * *

(3) A description and analysis of the

design and performance requirements

for structures, systems, and components

of the geologic repository that are

important to safety. The analysis must

include a demonstration that—(i) the

requirements of § 60.111(a) will be met,

assuming occurrence of Category 1

design basis events; and (ii) the

requirements of § 60.136 will be met,

assuming occurrence of Category 2

design basis events.

* * * * *

(8) A description of the controls that

the applicant will apply to restrict

access and to regulate land use at the

site and adjacent areas, including a

conceptual design of monuments which

would be used to identify the

postclosure controlled area after

permanent closure.

* * * * *

§ 60.43 [Amended]

5. In § 60.43(b)(5), the term

‘‘controlled area’’ is revised to read

‘‘postclosure controlled area.’’

§ 60.46 [Amended]

6. In § 60.46(a)(3), the term

‘‘controlled area’’ is revised to read

‘‘postclosure controlled area wherever it

appears.’’

§ 60.51 [Amended]

7. In § 60.51(a)(2)(i) and (a)(2)(ii), the

term ‘‘controlled area’’ is revised to read

‘‘postclosure controlled area.’’

§ 60.102 [Amended]

8. In § 60.102(c), the term ‘‘controlled

area’’ is revised to read ‘‘postclosure

controlled area.’’

9. In § 60.111, paragraph (a) is revised

to read as follows:

§ 60.111. Performance of the geologic

repository operations area through

permanent closure.

(a) Protection against radiation

exposures and releases of radioactive

material. The geologic repository

operations area shall be designed so that

until permanent closure has been

completed, radiation exposures and

radiation levels, and releases of

radioactive materials to unrestricted

areas, will be maintained within the

limits specified in part 20 of this

chapter and such generally applicable

environmental standards for

radioactivity as may have been

established by the Environmental

Protection Agency.

* * * * *

§ 60.121 [Amended]

10. In § 60.121(a) and (b), the term

‘‘controlled area’’ is revised to read

‘‘postclosure controlled area.’’

§ 60.122 [Amended]

11. In § 60.122(b)(6) and (c)

introductory text, the term ‘‘controlled

area’’ is revised to read ‘‘postclosure

controlled area.’’

12. Section 60.130 is revised to read

as follows:

§ 60.130 General considerations.

Pursuant to the provisions of

§ 60.21(c)(2)(i), an application to

receive, possess, store, and dispose of

high-level radioactive waste in the

geologic repository operations area must

include the principal design criteria for

a proposed facility. The principal design

criteria establish the necessary design,

fabrication, construction, testing,

maintenance, and performance

requirements for structures, systems,

and components important to safety

and/or important to waste isolation.

Sections 60.131 through 60.134 specify

minimum requirements for the principal

design criteria for the geologic

repository operations area. These design

criteria are not intended to be

exhaustive, however. Omissions in

§§ 60.131 through 60.134 do not relieve

DOE from any obligation to provide

such features in a specific facility

needed to achieve the performance

objectives.

13. In § 60.131, paragraph (b) is

revised, and paragraphs (c) through (k)

are added to read as follows:

§ 60.131 General design criteria for the

geologic repository operations area.

* * * * *

(b) Protection against design basis

events. The structures, systems, and

components important to safety shall be

designed so that they will perform their

necessary safety functions, assuming

occurrence of design basis events.

(c) Protection against dynamic effects

of equipment failure and similar events.

The structures, systems, and

components important to safety shall be

designed to withstand dynamic effects

such as missile impacts, that could

result from equipment failure, and

similar events and conditions that could

lead to loss of their safety functions.

(d) Protection against fires and

explosions. (1) The structures, systems,

and components important to safety

shall be designed to perform their safety

functions during and after credible fires

or explosions in the geologic repository

operations area.

(2) To the extent practicable, the

geologic repository operations area shall

be designed to incorporate the use of

noncombustible and heat resistant

materials.

(3) The geologic repository operations

area shall be designed to include

explosion and fire detection alarm

systems and appropriate suppression

systems with sufficient capacity and

capability to reduce the adverse effects

of fires and explosions on structures,

systems, and components important to

safety.

(4) The geologic repository operations

area shall be designed to include means

to protect systems, structures, and

components important to safety against

the adverse effects of either the

operation or failure of the fire

suppression systems.

(e) Emergency capability. (1) The

structures, systems, and components

important to safety shall be designed to

maintain control of radioactive waste

and radioactive effluents, and permit

prompt termination of operations and

evacuation of personnel during an

emergency.
15190 Federal Register / Vol. 60, No. 55 / Wednesday, March 22, 1995 / Proposed Rules

(2) The geologic repository operations

area shall be designed to include onsite

facilities and services that ensure a safe

and timely response to emergency

conditions and that facilitate the use of

available offsite services (such as fire,

police, medical, and ambulance service)

that may aid in recovery from

emergencies.

(f) Utility services. (1) Each utility

service system that is important to

safety shall be designed so that essential

safety functions can be performed,

assuming occurrence of the design basis

events.

(2) The utility services important to

safety shall include redundant systems

to the extent necessary to maintain, with

adequate capacity, the ability to perform

their safety functions.

(3) Provisions shall be made so that,

if there is a loss of the primary electric

power source or circuit, reliable and

timely emergency power can be

provided to instruments, utility service

systems, and operating systems,

including alarm systems, important to

safety.

(g) Inspection, testing, and

maintenance. The structures, systems,

and components important to safety

shall be designed to permit periodic

inspection, testing, and maintenance, as

necessary, to ensure their continued

functioning and readiness.

(h) Criticality control. All systems for

processing, transporting, handling,

storage, retrieval, emplacement, and

isolation of radioactive waste shall be

designed to ensure that nuclear

criticality is not possible unless at least

two unlikely, independent, and

concurrent or sequential changes have

occurred in the conditions essential to

nuclear criticality safety. Each system

must be designed for criticality safety

assuming occurrence of design basis

events. The calculated effective

multiplication factor (keff) must be

sufficiently below unity to show at least

a 5 percent margin, after allowance for

the bias in the method of calculation

and the uncertainty in the experiments

used to validate the method of

calculation.

(i) Instrumentation and control

systems. The design shall include

provisions for instrumentation and

control systems to monitor and control

the behavior of systems important to

safety, assuming occurrence of design

basis events.

(j) Compliance with mining

regulations. To the extent that DOE is

not subject to the Federal Mine Safety

and Health Act of 1977, as to the

construction and operation of the

geologic repository operations area, the

design of the geologic repository

operations area shall nevertheless

include such provisions for worker

protection as may be necessary to

provide reasonable assurance that all

structures, systems, and components

important to safety can perform their

intended functions. Any deviation from

relevant design requirements in 30 CFR,

Chapter I, Subchapters D, E, and N will

give rise to a rebuttable presumption

that this requirement has not been met.

(k) Shaft conveyances used in

radioactive waste handling. (1) Hoists

important to safety shall be designed to

preclude cage free fall.

(2) Hoists important to safety shall be

designed with a reliable cage location

system.

(3) Loading and unloading systems for

hoists important to safety shall be

designed with a reliable system of

interlocks that will fail safely upon

malfunction.

(4) Hoists important to safety shall be

designed to include two independent

indicators to indicate when waste

packages are in place and ready for

transfer.

14. In § 60.132, paragraph (c)(1) is

revised to read as follows:

§ 60.132. Additional design criteria for

surface facilities in the geologic repository

operations area.

* * * * *

(c) Radiation control and

monitoring—(1) Effluent control. The

surface facilities shall be designed to

control the release of radioactive

materials in effluents so as to meet the

performance objectives of § 60.111(a).

* * * * *

15. In § 60.133, the introductory text

of paragraph (g) and paragraph (g)(2) are

revised to read as follows:

§ 60.133 Additional design criteria for the

underground facility.

* * * * *

(g) Underground facility ventilation.

The ventilation system shall be

designed to:

* * * * *

(2) Assure the ability to perform

essential safety functions assuming

occurrence of design basis events; and

* * * * *

16. A new undesignated center

heading and § 60.136 are added to read

as follows:

Preclosure Controlled Area

§ 60.136 Preclosure controlled area.

(a) A preclosure controlled area must

be established for the geologic

repository operations area.

(b) The geologic repository operations

area shall be designed so that, for

Category 2 design basis events, no

individual located on or beyond the

nearest boundary of the preclosure

controlled area will receive the more

limiting of a total effective dose

equivalent of 0.05 Sv (5 rem), or the sum

of the deep-dose equivalent and the

committed dose equivalent to any

individual organ or tissue (other than

the lens of the eye) of 0.5 Sv (50 rem).

The eye dose equivalent may not exceed

0.15 Sv (15 rem), and the shallow dose

equivalent to skin may not exceed 0.5

Sv (50 rem). The minimum distance

from the surface facilities in the geologic

repository operations area to the

boundary of the preclosure controlled

area must be at least 100 meters.

(c) The preclosure controlled area

may be traversed by a highway, railroad,

or waterway, so long as appropriate and

effective arrangements are made to

control traffic and to protect public

health and safety.

17. In § 60.183, paragraph (b) is

revised to read as follows:

§ 60.183 Criminal penalties.

* * * * *

(b) The regulations in part 60 that are

not issued under sections 161b, 161i, or

161o for the purposes of section 223 are

as follows: §§ 60.1, 60.2, 60.3, 60.5, 60.6,

60.7, 60.8, 60.15, 60.16, 60.17, 60.18,

60.21, 60.22, 60.23, 60.24, 60.31, 60.32,

60.33, 60.41, 60.42, 60.43, 60.44, 60.45,

60.46, 60.51, 60.52, 60.61, 60.62, 60.63,

60.64, 60.65, 60.101, 60.102, 60.111,

60.112, 60.113, 60.121, 60.122, 60.130,

60.131, 60.132, 60.133, 60.134, 60.135,

60.136, 60.137, 60.140, 60.141, 60.142,

60.143, 60.150, 60.151, 60.152, 60.162,

60.181, and 60.183.

Dated in Rockville, Maryland, this 15th

day of March, 1995.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 95–6872 Filed 3-21–95; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 60

[Docket No. PRM–60–3]

Disposal of High-Level Radioactive

Wastes in Geologic Repositories

AGENCY: U.S. Nuclear Regulatory

Commission.

ACTION: Partial grant/partial denial of

petition for rulemaking.

SUMMARY: In a petition for rulemaking

(PRM–60–3) submitted by the U.S.