17902 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

NUCLEAR REGULATORY

COMMISSION

10 CFR PART 52

RIN 3150–AE87

Standard Design Certification for the

U.S. Advanced Boiling Water Reactor

Design

AGENCY: Nuclear Regulatory

Commission.

ACTION: Proposed rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC or Commission)

proposes to approve by rulemaking a

standard design certification for the U.S.

Advanced Boiling Water Reactor

(ABWR) design. The applicant for

certification of the U.S. ABWR design

was GE Nuclear Energy. The NRC is

proposing to add a new appendix to 10

CFR part 52 for the design certification.

This action is necessary so that

applicants or licensees intending to

construct and operate a U.S. ABWR

design may do so by appropriately

referencing the proposed appendix. The

public is invited to submit comments on

this proposed design certification rule

(DCR) and the design control document

(DCD) that is incorporated by reference

into the DCR (refer to Sections IV and

V). The Commission also invites the

public to submit comments on the

environmental assessment for the U.S.

ABWR design (refer to Section VI).

DATES: The comment period expires on

August 7, 1995. Comments received

after this date will be considered if it is

practical to do so, but the Commission

is only able to assure consideration for

comments received on or before this

date. In addition, interested parties may

request an informal hearing before the

Atomic Safety and Licensing Board

Panel, in accordance with 10 CFR 52.51,

on matters pertaining to this design

certification rulemaking (refer to Section

V). Requests for an informal hearing

must be submitted by August 7, 1995.

ADDRESSES: Mail written comments and

requests for an informal hearing to: The

Secretary of the Commission, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555, Attention:

Docketing and Service Branch.

Comments may also be delivered to

11555 Rockville Pike, Rockville, MD,

between 7:30 am and 4:15 pm on

Federal workdays. Copies of comments

received will be available for

examination and copying at the NRC

Public Document Room (PDR) at 2120 L

Street NW. (Lower Level), Washington,

DC. A copy of the environmental

assessment and the design control

document is also available for

examination and copying at the PDR.

FOR FURTHER INFORMATION CONTACT:

Harry S. Tovmassian, Office of Nuclear

Regulatory Research, telephone (301)

415–6231, Jerry N. Wilson, Office of

Nuclear Reactor Regulation, telephone

(301) 415–3145, or Geary S. Mizuno,

Office of the General Counsel, telephone

(301) 415–1639, U.S. Nuclear Regulatory

Commission, Washington, DC 20555.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background.

II. Public comment summary and resolution.

Topic 1—Acceptability of a Two-Tiered

Design Certification Rule Structure

Topic 2—Acceptability of the Process and

Standards for Changing Tier 2

Information

Topic 3—The Acceptability of a Tier 2

Exemption

Topic 4—Acceptability of Using a Change

Process, Similar to the One in 10 CFR

50.59 Applicable to Operating Reactors,

Prior to the Issuance of a Combined

License that References a Certified

Design

Topic 5—The Acceptability of Identifying

Selected Technical Positions From the

FSER as ‘‘Unreviewed Safety Questions’’

that Cannot Be Changed Under a

‘‘Section 50.59-Like’’ Change Process

Topic 6—Need for Modifications to 10 CFR

52.63(b)(2) If the Two-Tiered Structure

for the Design Certification Rule is

Approved

Topic 7—Whether the Commission Should

Either Incorporate or Identify the

Information in Tier 1 or Tier 2 or Both

in the Combined License

Topic 8—Acceptability of Using Design

Specific Rulemakings Rather Than

Generic Rulemaking for the Technical

Issues Whose Resolution Exceeds

Current Requirements

Topic 9—The Appropriate Form and

Content of a Design Control Document

III. Section-by-section discussion of design

certification rule.

A. Scope.

B. Definitions.

C. [Reserved].

D. Contents of the design certification.

E. Exemptions and applicable regulations.

F. Issue resolution for the design

certification.

G. Duration of the design certification.

H. Change process.

I. Records and reports.

J. Applicability of a DCR in 10 CFR Part 50

licensing proceedings.

IV. Specific requests for comments.

V. Comments and hearings in the design

certification rulemaking.

A. Opportunity to submit written and

electronic comments.

B. Opportunity to request hearing.

C. Hearing process.

D. Resolution of issues for the final

rulemaking.

E. Access to proprietary information in

rulemaking.

F. Ex parte and separation of functions

restrictions.

VI. Finding of no significant environmental

impact: availability.

VII. Paperwork reduction act statement.

VIII. Regulatory analysis.

IX. Regulatory Flexibility Act certification.

X. Backfit analysis.

I. Background

On September 29, 1987, General

Electric Company applied for

certification of the U.S. ABWR standard

design with the NRC. The application

was made in accordance with the

procedures specified in 10 CFR part 50,

appendix O, and the Policy Statement

on Nuclear Power Plant

Standardization, dated September 15,

1987. The application was docketed on

February 22, 1988 (Docket No. STN 50–

605).

On May 18, 1989 (54 FR 15372), the

NRC added 10 CFR part 52 to its

regulations to provide for the issuance

of early site permits, standard design

certifications, and combined licenses for

nuclear power reactors. Subpart B of 10

CFR part 52, established the process for

obtaining design certifications. A major

purpose of this rule was to achieve early

resolution of licensing issues and to

enhance the safety and reliability of

nuclear power plants.

On December 20, 1991, GE Nuclear

Energy (GE), an operating component of

General Electric Company’s power

systems business, requested that its

application, originally submitted

pursuant to 10 CFR part 50, appendix O,

be considered as an application for

design approval and subsequent design

certification pursuant to 10 CFR 52.45.

Notice of receipt of this request was

published in the Federal Register on

March 20, 1992 (57 FR 9749), and a new

docket number (52–001) was assigned.

GE’s application, the ABWR Standard

Safety Analysis Report (SSAR) up to

and including amendment 35 (Revision

7) and the Certified Design Material,

Revision 6, is available for inspection

and copying at the PDR.

The NRC staff issued a final safety

evaluation report (FSER) related to the

certification of the U.S. ABWR design in

July 1994 (NUREG–1503). The FSER

documents the results of the NRC staff’s

safety review of the U.S. ABWR design

against the requirements of 10 CFR part

52, subpart B, and delineates the scope

of the technical details considered in

evaluating the proposed design. A copy

of the FSER may be obtained from the

Superintendent of Documents,

Government Printing Office, Mail Stop

SSOP, Washington, DC 20402–9328 or

the National Technical Information
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17903

1AECL is the vendor for the CANDU 3 design.

Service, Springfield, VA 22161. The

final design approval (FDA) for the U.S.

ABWR design was issued on July 13,

1994, and published in the Federal

Register on July 20, 1994 (59 FR 37058).

A revised version of the FDA was issued

on November 23, 1994 and published in

the Federal Register on December 1,

1994 (59 FR 61647).

Since the issuance of 10 CFR part 52,

the NRC staff has been working to

implement subpart B with issues such

as the acceptability of using a two-tiered

design certification rule and the level of

design detail required for design

certification. The NRC staff originally

proposed a design certification rule for

evolutionary standard plant designs in

SECY–92–287, ‘‘Form and Content for a

Design Certification Rule.’’ On March

26, 1993, the NRC staff issued SECY–

92–287A in which it responded to

issues on SECY–92–287, which were

put forth by the Commission and to

specific questions raised by

Commissioner Curtiss in a letter dated

September 9, 1992. Subsequently, the

NRC staff modified the draft rule in

SECY–92–287 to incorporate

Commission guidance and published a

draft-proposed design certification rule

in the Federal Register on November 3,

1993 (58 FR 58665), as an Advanced

Notice of Proposed Rulemaking (ANPR)

for public comment. On November 23,

1993, the NRC staff discussed this

ANPR in a public workshop entitled

‘‘Topics Related to Certification of

Evolutionary Light Water Reactor

Designs.’’ All holders of operating

licenses or construction permits were

informed of the issuance of the ANPR

and the planned public workshop

through the issuance of NRC

Administrative Letter 93–05 on October

29, 1993. Separate announcements of

the workshop were also sent to the

Union of Concerned Scientists, the

Nuclear Information and Resource

Service, the Natural Resources Defense

Council, the Public Citizen Litigation

Group, the Ohio Citizens for

Responsible Energy (OCRE), and the

State of Illinois Department of Nuclear

Safety on October 18, 1993. An official

transcript of the workshop proceedings

is available in the PDR.

Rulemaking Procedures

10 CFR part 52 provides for

Commission approval of standard

designs for nuclear power facilities (e.g.,

design certification) through

rulemaking. In accordance with the

Administrative Procedure Act (APA),

part 52 provides the opportunity for the

public to submit written comments on

the proposed design certification rule.

However, part 52 goes beyond the

requirements of the APA by providing

the public with an opportunity to

request a hearing before the Atomic

Safety and Licensing Board in a design

certification rulemaking. While part 52

describes a general framework for

conducting a design certification

rulemaking, § 52.51(a) states that more

detailed procedures for the conduct of

each design certification will be

specified by the Commission.

To assist the Commission in

developing the detailed rulemaking

procedures, the NRC’s Office of General

Counsel (OGC) prepared a paper, SECY–

92–170 (May 8, 1992), which identified

issues relevant to design certification

rulemaking procedures, and provided

OGC’s preliminary analyses and

recommendations with respect to those

issues. SECY–92–170 was made public

by the Commission, and a Commission

meeting on this paper was held on June

1, 1992.

Thereafter, in SECY–92–185 (May 19,

1992), OGC proposed holding a public

workshop for the purpose of facilitating

public discussion on the issues raised in

SECY–92–170 and obtaining public

comments on those issues. The

Commission approved OGC’s proposal

(See the May 28, 1992, Memorandum

from Samuel J. Chilk to William C.

Parler). Notice of the workshop was

published in the Federal Register on

June 9, 1992 (57 FR 24394). The notice

also provided for a 30-day period

following the workshop for the public to

submit written comments on SECY–92–

170. A transcript was kept of the

workshop proceedings and placed in the

PDR. Nearly 50 non-NRC individuals

attended the workshop; an additional

eight persons requested copies of SECY–

92–170 and workshop materials but did

not attend. The workshop was organized

in a panel format, with representatives

from OCRE (Susan Hiatt), NUMARC

(Robert Bishop), GE and

Westinghouse—two design certification

vendors (Marcus Rowden and Barton

Cowan), the State of Illinois Department

of Nuclear Safety (Stephen England), the

State of New York Public Service

Commission (James Brew), the

Administrative Conference of the

United States (William Olmstead), OGC,

the NRC Staff, and a moderator. Eleven

written comments were received after

the workshop, three from OCRE (OCRE

August 1992 Comments; OCRE

September 1992 Letter; OCRE October

1992 Letter), NUMARC, Winston and

Strawn, the State of Illinois Department

of Nuclear Safety, Westinghouse Energy

Systems, the U.S. Department of Energy,

Asea Brown Boveri-Combustion

Engineering (ABB–CE), and AECL

Technologies 1. Mr. Rowden submitted

an additional comment on behalf of

NUMARC which addresses proprietary

information.

OGC’s final analyses and

recommendations for design

certification rulemaking procedures

were set forth in SECY–92–381

(November 10, 1992). This paper was

prepared after consideration of the

panel discussions at the public

workshop and the written comments

received after the workshop. On April

30, 1993, the Commission issued a

Memorandum to the General Counsel

which sets forth the Commission’s

determinations with respect to the

procedural issues raised by the General

Counsel’s paper. Section V. below,

‘‘Comments and Hearings in the Design

Certification Rulemaking,’’ describes the

procedures to be utilized in this design

certification rulemaking.

II. Public Comment Summary and

Resolution

The public comment period for the

ANPR for rulemakings to grant standard

design certification for evolutionary

light water reactor designs expired on

January 3, 1994. Six comment letters

were received. Five comment letters

were from the nuclear industry (i.e.,

vendors, utilities, and industry

representatives) and one from a public

interest organization. Most of the

commenters addressed the nine topics

upon which the NRC sought the public’s

views. The Commission has carefully

considered all the comments and wishes

to express its sincere appreciation of the

often considerable efforts of the

commenters.

In the following public comment

summary and resolution and in the

section-by-section discussion (Section

III below), the discussion refers to

‘‘Commission approval’’ of NRC staffproposed positions or

recommendations. This should be

understood as meaning the

Commission’s tentative approval of

those positions or recommendations for

purposes of: (i) The NRC staff’s review

of the ABWR design certification

application, and (ii) preparation of this

notice of proposed rulemaking. The

public may submit comments and

request an informal hearing with respect

to any of the ‘‘Commission approved’’

positions or recommendations

(comments and hearings are discussed

in further detail in Section V).

All of the commenters supported the

basic concept of the design certification

rulemaking approach including the twotiered structure for design information.
17904 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

The Nuclear Management and

Resources Council, which has since

been subsumed within the Nuclear

Energy Institute (NEI), commented for

the nuclear industry. GE Nuclear

Energy, Westinghouse, and ABB–CE

stated that they participated in the

preparation of the NEI comments and

fully supported them. One additional

letter addressing the U.S. ABWR

rulemaking was received from Marcus

Rowden of the law firm of Fried, Frank,

Harris, Shriver & Jacobson, dated

September 20, 1994. This letter was

written on behalf of GE Nuclear Energy

and contained a proposed draft rule for

the NRC staff’s consideration in the U.S.

ABWR rulemaking process. Mr.

Rowden’s proposed rule is different in

some aspects from the rule proposed by

the NRC staff in this Federal Register

notice. The issues raised by the

significant differences between Mr.

Rowden’s proposed rule and the

proposed rule in this Federal Register

notice have been appropriately

considered and discussed in the

following public comment summary

and resolution or in the section-bysection discussion:

Topic 1—Acceptability of a Two-Tiered

Design Certification Rule Structure

Comment Summary. On behalf of the

nuclear industry, NEI stated that a twotiered structure to a design certification

rule is practical and fully consistent

with the intent and requirements of 10

CFR part 52. OCRE stated that it fully

supports the concept set forth in the

ANPR provided that the Tier 2

information is subject to public

challenge in the standard design

certification and any associated hearing.

Response. Although a two-tiered

structure for design certification rules

was not envisioned or subsequently

deemed necessary to implement

standard design certifications under 10

CFR part 52, the Commission approved

the use of a two-tiered structure for a

design certification rule in its SRM of

February 15, 1991, on SECY–90–377,

‘‘Requirements for Design Certification

Under 10 CFR part 52,’’ in response to

a request from NEI dated August 31,

1990. Since then, the NRC staff has

worked to develop a two-tiered rule that

achieves industry’s goal of issue

preclusion for a greater amount of

information than was originally planned

for design certification, while retaining

flexibility for design implementation.

Tier 1 information is defined in

section 2(b) of the proposed rule and is

treated as the certified information that

is controlled by the change standards of

10 CFR 52.63. Tier 2 information is

defined in section 2(c) of the proposed

rule and consists primarily of the

information submitted in an application

for design certification. The information

in the two tiers is interdependent.

Therefore, an applicant for a

construction permit, operating license,

or combined license (COL) that

references this design certification must

reference both tiers of information. The

consolidation of both tiers of

information into a Design Control

Document (DCD) will provide an

effective means of maintaining this

information and facilitating its

incorporation into the rule by reference.

All matters covered in each tier,

including the determination of what

information should be placed in each

tier, are subject to public challenge in

the design certification rulemaking and

any associated hearing.

Topic 2—Acceptability of the Process

and Standards for Changing Tier 2

Information

Comment Summary. NEI concurs in

the process and standards to be used by

COL holders and applicants for

evaluating and implementing changes to

Tier 2 information via the so-called

‘‘§ 50.59-like’’ change process. However,

NEI does not agree with the statement

in the ANPR (Section A.13(d)(3)) that

‘‘changes properly implemented

through this ‘‘§ 50.59-like’’ process

cause a loss of finality relative to the

affected portion of the design or are

subject to subsequent legal challenge.’’

NEI contends that these changes would

be sanctioned through the design

certification rule and that the only issue

entertainable at the time of the COL

licensing proceeding would be whether

the licensee complied with the ‘‘§ 50.59-

like’’ change process. Likewise, changes

made subsequent to COL issuance could

be challenged in the part 52 proceeding

before fuel-load authorization only on

the basis that the change resulted in

noncompliance with applicable

acceptance criteria. However, NEI

recognizes that changes from Tier 2 that

require NRC approval would be subject

to a hearing opportunity as specified in

10 CFR part 52.

OCRE stated that it is important that

applicant or licensee initiated changes

to Tier 2 information made pursuant to

the ‘‘§ 50.59-like’’ process will no longer

be afforded the issue preclusion

protection of 10 CFR 52.63. To do

otherwise would turn the two-tiered

system into a double standard in which

utilities could deviate from the standard

design but the public could not

challenge these deviations. Permitting

site-specific litigation of these changes

would also serve to discourage changes.

Response. In order to implement the

two-tiered structure for design

certification rules, the Commission

proposes a change process for Tier 2

information that has the same elements

as the Tier 1 change process.

Specifically, the Tier 2 change process

has provisions for generic changes,

plant-specific changes, and exemptions

similar to those in 10 CFR 52.63.

Although the NRC staff proposed that

the backfitting standards for making

generic changes to Tier 2 information

should be less stringent than those for

Tier 1 information, the Commission

disapproved this proposal in its SRM on

SECY–92–287A, dated June 13, 1993,

and stated that ‘‘the backfitting

standards of 10 CFR 52.63 should be

applied for such changes to Tier 2.’’ As

a result, the NRC staff adopted the

backfitting standards of 10 CFR 52.63 in

the Tier 2 change process proposed in

the ANPR, except that the additional

factor regarding ‘‘any decrease in safety

that may result from the reduction in

standardization’’ was not adopted for

plant-specific changes and exemptions

in order to achieve additional flexibility

for Tier 2 information.

The Tier 2 change process also has a

provision similar to 10 CFR 50.59 that

allows changes to Tier 2 information by

an applicant or licensee, without prior

NRC approval, subject to certain

restrictions. The Commission approved

this process in its SRM on SECY–90–

377, dated February 15, 1991, provided

‘‘that such changes open the possibility

for challenge in a hearing.’’ The NRC

staff followed the Commission’s

guidance in developing the process in

ANPR Section A.13(d)(3) that allows

certain changes to Tier 2 information,

without prior NRC approval. This

section of the ANPR states that ‘‘Tier 2

changes will no longer be considered

matters resolved in connection with the

issuance or renewal of a design

certification within the meaning of 10

CFR 52.63(a)(4).’’ The NRC staff

included this provision to meet

Commission guidance and to restrain

Tier 2 changes in order to maintain the

benefits of standardization, as discussed

in SECY–92–287. Also, changes may be

challenged in individual COL

proceedings since the changes depart

from the design information approved

in the design certification rulemaking.

Therefore, the Commission agrees with

the OCRE position on issue preclusion

and specifically invites comments on

this provision (see Section IV).

Topic 3—The Acceptability of a Tier 2

Exemption

Comment Summary. NEI supports the

inclusion of the provision that an
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17905

applicant or licensee may request, and

the NRC may grant, an exemption to

Tier 2 information. OCRE indirectly

supports the Tier 2 exemption provision

but recommends that the sentence:

‘‘These Tier 2 changes will no longer be

considered matters resolved in

connection with the issuance or renewal

of a design certification within the

meaning of 10 CFR 52.63(a)(4)’’ also be

included in the section A.13(d)(2) of the

ANPR on exemptions from Tier 2

information, for clarity, and because 10

CFR 52.63(b)(1) does not mention the

two-tiered system.

Response. In SECY–92–287A, the

NRC staff proposed the addition of an

exemption provision to the Tier 2

change process so that the change

process for both tiers would have the

same elements and to provide

additional flexibility to applicants or

licensees that reference a design

certification rule. The Commission

deferred its decision on an exemption to

the Tier 2 change process in its SRM

dated June 23, 1993, and requested the

NRC staff to solicit public comments on

this issue.

Because no commenter objected to the

addition of a Tier 2 exemption process

and NEI supported the proposal, the

provision was retained in the proposed

rule. However, OCRE proposed that Tier

2 exemptions lose issue preclusion

consistent with Tier 1 exemptions.

Because that is consistent with the NRC

staff’s approach to Tier 2 changes and

the Commission’s guidance in its SRM

on SECY–90–377 (see response to topic

#2), OCRE’s proposal has been

incorporated into the proposed rule.

The additional standard in the Tier 1

exemption process, which requires that

‘‘any decrease in safety that may result

from the reduction in standardization

caused by the exemption’’ outweighs

the special circumstances in 10 CFR

50.12, was not included in the Tier 2

exemption process because the

Commission views Tier 2 information as

more detailed descriptions of Tier 1

information that should have a less

stringent change standard than Tier 1

and the industry requested additional

flexibility for Tier 2 information.

Therefore, the proposed Tier 2 change

process uses the same standard that is

used for Part 50 exemptions, namely 10

CFR 50.12. The Commission believes

that the loss of issue preclusion for Tier

2 exemptions will help minimize the

consequences of the loss of

standardization caused by these

exemptions.

Topic 4—Acceptability of Using a

Change Process, Similar to the one in 10

CFR 50.59 Applicable to Operating

Reactors, Prior to the Issuance of a

Combined License that References a

Certified Design.

Comment Summary. NEI concurs in

the NRC’s proposal to have the ‘‘§ 50.59-

like’’ change process apply to both COL

applicants and licensees.

Response. In its SRM on SECY–92–

287A, dated June 23, 1993, the

Commission approved the NRC staff’s

proposal to extend the use of the

‘‘§ 50.59-like’’ change process for Tier 2

information to applicants that reference

a certified design. Because NEI and

other commenters supported this

proposal, this additional flexibility has

been retained for the proposed rule.

Topic 5—The Acceptability of

Identifying Selected Technical Positions

From the FSER as ‘‘Unreviewed Safety

Questions’’ That Cannot Be Changed

Under a ‘‘Section 50.59-Like’’ Change

Process

Comment Summary. NEI commented

that the proposal to predesignate

changes to certain design aspects as

constituting ‘‘unreviewed safety

questions’’ is unnecessary and is

tantamount to the creation of a third tier

of information, which runs counter to

the two-tier structure. NEI proposed that

the selected Tier 2 material be

designated, not broadly in the rule, but

specifically in the SSAR/FSER and the

DCD as requiring NRC staff notification

before implementing the changes. NEI

argued that at the time of notification,

the NRC staff could decide whether the

proposed change constitutes an

‘‘unreviewed safety question,’’ and the

applicant or COL holder would be

prohibited from making the change

without either NRC staff concurrence or

a successful appeal of the NRC staff’s

determination. NEI also envisioned a

time, subsequent to completion of

designs and the inspections, tests,

analyses, and acceptance criteria

(ITAAC), when the change restriction

for selected Tier 2 material will no

longer be necessary. NEI further stated

that, whether or not the Commission

adopts NEI’s proposal, the NRC staff

should be limited to design areas

discussed with plant designers when

designations of ‘‘unreviewed safety

questions’’ are made. Also, these special

designations should be as narrow and

specific as practicable to avoid the

inadvertent broadening of this special

category of Tier 2 design information

and the excessive restrictions against

change that would result.

Response. The NRC’s proposal to

predesignate certain Tier 2 information

that cannot be changed without prior

NRC approval does not create a third

tier of information or conflict with the

two-tiered rule structure. In fact, this socalled Tier 2* information was created

as a consequence of industry’s

implementation of the two-tiered rule

structure. Specifically, industry’s desire

to minimize the amount of information

in Tier 1 and to use design acceptance

criteria in lieu of design information in

certain areas resulted in the need to

identify significant Tier 2 information

that could not be changed by an

applicant or licensee without prior NRC

approval. The previous reference to

‘‘identified unreviewed safety

questions’’ in the ANPR was made to

indicate that the process for changing

the so-called Tier 2* information would

be the same as for changing other Tier

2 information that an applicant or

licensee determines to constitute an

unreviewed safety question. Therefore,

there is no third tier of information.

Rather, some Tier 2 information cannot

be changed without prior NRC approval

and the remainder can. This is no

different than the information in a Final

Safety Analysis Report relative to the

process in 10 CFR 50.59.

The Commission agrees with NEI that

it would be clearer to future users of the

certified design if the specific

information that has been designated as

requiring prior NRC approval (Tier 2*)

is identified in the DCD rather than

summarized in the design certification

rule (DCR). However, the requirement

for prior NRC approval does need to be

specified in the DCR for the Tier 2

change process. Therefore, the NRC

instructed the applicants to identify the

Tier 2* information in the DCD.

In response to NEI’s request, the DCR

will not identify the Tier 2* information

as an unreviewed safety question

because that designation is not required;

only prior NRC approval is required.

Therefore, the Tier 2 change process has

been revised to state that Tier 2*

information identified in the DCD

cannot be changed without prior NRC

approval. Although Tier 2* changes may

not result in unreviewed safety

questions, the public will be afforded an

opportunity to challenge the changes

(see response to topic #2). The

Commission also that the

predesignation of some of the Tier 2*

information can expire when the plant

first achieves 100% power while other

Tier 2* information must remain in

effect throughout the life of the plant

that references the DCR. This is because

there is sufficient information in some

of the related areas of Tier 1 to control
17906 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

changes after the plant is completed.

The appropriate expiration point is

designated in their DCDs.

The NEI proposal to require

notification of the NRC rather than

requiring NRC approval prior to

changing the Tier 2* information would

create an unnecessary burden on the

NRC in the Tier 2 change process. The

Commission has already determined

that the predesignated Tier 2*

information is significant and cannot be

changed before NRC approval.

Therefore, the Commission has not

adopted the ‘‘notification’’ proposal.

Also, the designation of Tier 2*

information is not an excessive

restriction on the change process.

Rather, it compensates for industry’s

request to minimize the amount of

information in Tier 1.

Topic 6—Need for Modifications to 10

CFR 52.63(b)(2) If the Two-Tiered

Structure for the Design Certification

Rule is Approved

Comment Summary. OCRE

commented that modifications to

§ 52.63 are not necessary because the

design certification rules would also

become regulations. NEI commented

that changes to 10 CFR part 52 are not

needed at this time but that some

changes to part 52 may be identified as

appropriate for future consideration

based on experience with the initial

design certifications.

Response. When part 52 was written,

§ 52.63(b)(2) was intended to be the

change process for information that was

not referenced in the design certification

rule (non-certified information). Now

that the Commission has decided to

implement a two-tiered rule structure as

described in the response to Topic #1,

the two-tiered change process applies to

all information referenced by the design

certification rule. Therefore, there does

not appear to be a need for § 52.63(b)(2)

in a two-tiered rule structure.

In the absence of any perceived need

for changes to 10 CFR 52.63(b)(2) to

accommodate the two-tiered concept in

design certification, the Commission

does not intend to modify 10 CFR part

52 at this time. However, as NEI

suggests, the Commission is evaluating

the need for changes to part 52 as it

gains experience with the initial design

certification reviews.

Topic 7—Whether the Commission

Should Either Incorporate or Identify

the Information in Tier 1 or Tier 2 or

Both in the Combined License

Comment Summary. On the question

of whether Tier 1 or Tier 2 information

should be incorporated in the combined

license (COL) or identified in the COL,

NEI stated that this question need not be

resolved for design certification

purposes but provided two alternatives

for future NRC consideration.

Alternative one would be to incorporate

Tier 1 information and identify Tier 2

information in the COL. The second

alternative would be to incorporate both

tiers of information in the rule, provided

that the Tier 2 change provisions are

incorporated in the rule as well.

OCRE stated that both Tier 1 and Tier

2 information should be incorporated in

the COL because both tiers contain

important design information.

Response. The NRC is deferring the

decision on this issue because

resolution of this issue is not needed to

develop a design certification rule.

However, because the commenters all

supported incorporation of both tiers of

information, the NRC staff will evaluate

that option for a combined license

under subpart C of 10 CFR part 52.

Topic 8—Acceptability of Using Design

Specific Rulemakings Rather Than

Generic Rulemaking for the Technical

Issues Whose Resolution Exceeds

Current Requirements

Comment Summary. NEI, GE Nuclear

Energy, and Westinghouse Electric

Corporation took exception with the

NRC position on the issue of designating

severe accident and technical

requirements, beyond those in current

regulations as ‘‘applicable regulations’’

in the design certification rule. NEI

stated that ‘‘Commission approved NRC

staff positions will be reflected in a

design certification rule by means of

design provisions contained in Tier 1

and Tier 2 of the DCD incorporated in

the rule.’’ NEI argued that the NRC

staff’s proposed approach would result

in needless duplication, complexity,

and delay because matters that have

been agreed to in detail would then be

formulated in broadly stated positions

requiring another round of extensive

discussions to reach agreement in a

process equivalent to a series of

complex, discrete rulemakings. In

addition, NEI stated that these ‘‘broadly

stated, free standing applicable

regulations carry the potential for new

and diverse interpretations by the NRC

staff during the life of the design

certification.’’ These interpretations may

be at odds with the understandings that

translated into specific Tier 1 and Tier

2 requirements in the DCD. GE Nuclear

Energy reiterated these comments but

added that ‘‘The course proposed by the

NRC staff would enormously complicate

pre-rulemaking preparation, the conduct

of the rulemakings themselves and COL

licensing and post-licensing facility

construction and operation. It would,

moreover, impose schedule delays and

generate needless duplication, if not

outright conflicts.’’ Also, NEI saw little

difference between the proposal to

incorporate applicable regulations in

design certification rules and the similar

effect of proceeding with generic severe

accident rulemaking.

OCRE stated that the resolution of

technical issues whose resolution

exceeds current requirements will likely

be design-specific and therefore, it may

make little difference whether the

rulemakings are design-specific or

generic. OCRE further stated that, if the

NRC wants all plants constructed after

a certain date to incorporate certain

design features or otherwise address

certain technical issues, then a generic

rulemaking may be the safest and most

cost-effective way to accomplish this

goal. OCRE also noted that a generic

rule would cover an applicant that

might decide not to use a standard

certified design.

Response. The Commission has used

design-specific rulemaking rather than

generic rulemaking for the selected

technical and severe accident issues that

go beyond current requirements for

light-water reactors (LWRs). The

Commission adopted this approach,

early in the review process, because it

believed that the new requirements

would be design-specific, as OCRE

stated. Also, the NRC was concerned

that generic rulemakings would cause

significant delay in the design

certification reviews. The Commission

approved this approach in its SRM on

SECY–91–262, dated January 28, 1992,

and has continued to support this

approach for evolutionary LWRs, as

stated in its SRM on SECY–93–226,

dated September 14, 1993. The

Commission has deferred its decision on

the need for generic rulemaking for

advanced LWRs.

Both the industry and OCRE

concluded that there would be little

difference in the requirements for the

certified designs, regardless if the

approach was generic or design-specific.

The Commission agrees that at the

conclusion of the design certification

rulemaking the effect of the new

regulations is basically the same but that

the specific wording of the regulations

may have been different if generic

rulemaking was used.

In implementing the goals of 10 CFR

part 52 and the Commission’s Severe

Accident Policy Statement (50 FR

32138; August 8, 1985), the NRC staff

set out to achieve a higher level of safety

performance for both evolutionary and

passive LWR designs in the area of

severe accidents and in other selected

areas. The NRC staff proposed new
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requirements to implement these goals

in various Commission papers, such as

SECY–90–016 and SECY–93–087. The

NRC staff then selected the applicable

requirements for each evolutionary

design and evaluated the design

information that describes how those

requirements were met in the FSERs for

the U.S. ABWR and System 80+ designs.

In the proposed rule for each design, the

NRC has identified these requirements

as applicable regulations in order to

specify the requirements that were

applicable and in effect at the time the

certification was issued for the purposes

of §§ 52.48, 52.54, 52.59, and 52.63.

These applicable regulations, which

were identified in each FSER, are set

forth in the design certification rule,

with minor editing, to achieve

codification through the design

certification rulemaking. These codified

regulations, which supplement the list

of regulations in § 52.48, become part of

the Commission’s regulations that are

‘‘applicable and in effect at the time the

certification was issued.’’ Without this

complete list of applicable regulations,

the NRC staff could not perform reviews

in accordance with §§ 52.59 and 52.63.

By codifying these requirements, the

NRC intends to make it clear that for the

purpose of renewal of a certified design

under § 52.59, these requirements are

part of the applicable regulations in

effect at the time that the design

certification was first issued. The NRC

also intends to make it clear that the

Commission may, pursuant to § 52.63(a)

(1) and (3), impose modification of Tier

1 information or to issue a plant-specific

order, respectively, to ensure that the

certified design or the plant complies

with the applicable regulations of the

design certification rule. The rationale is

that the Commission could not, without

re-reviewing the merits of each position,

impose a change to Tier 1 information

or issue a plant-specific order merely

because the modification was necessary

for compliance with a matter involving

these proposed requirements. Also, the

Commission would not have a complete

baseline of regulations for evaluating

proposed changes from the public,

applicants, or licensees, thereby

degrading the predictability of the

licensing process.

The codification of these proposed

requirements, in reference to § 52.48, is

also necessary for two other reasons.

First, it serves as a basis for obtaining

public comment on the proposed

adoption of the requirements as

applicable regulations. Second, it

provides confirmation that the

requirements are being adopted by the

Commission as applicable regulations

under § 52.54 for the design certification

being approved. In the absence of this

codification, a design certification

applicant could argue that the

Commission cannot lawfully condition

approval of the design certification on

compliance with the proposed

requirements used during its review of

the design. This is because the

requirements are not ‘‘applicable

standards and requirements of the

* * * Commission’s regulations’’

without further Commission action

under § 52.54.

By identifying the regulations that are

applicable to each design, the

Commission has improved the stability

and predictability of the licensing

process. By approving the design

information that describes how these

regulations were met, the Commission

has minimized the potential for a

differing interpretation of the

regulations. Finally, the NRC staff told

NEI in a meeting on April 25, 1994, and

in a letter dated July 25, 1994, that the

industry-proposed alternative to

applicable regulations was

unacceptable. The NRC staff stated that

design information cannot function as a

surrogate for design-specific (applicable)

regulations because this information

describes only one method for meeting

the regulation and would not provide a

basis for evaluating proposed changes to

the design information. Therefore,

consideration of the comments on Topic

#8 has not altered the Commission’s

decision to proceed with design-specific

rulemaking for the proposed

requirements and to publish the

appropriate applicable regulations in

each design certification rule.

Topic 9—The Appropriate Form and

Content of a Design Control Document

Comment Summary. Concerning the

form and content of the DCD, NEI

envisioned a document that consisted of

three parts including an introductory

section, Tier 1 information, and Tier 2

information. NEI also proposed an

algorithm that described the industry’s

view of the contents of a DCD.

NEI stated that, based on its

interactions with the NRC staff on the

guidance for preparing a DCD, two main

issues have emerged. The first issue is

the nature and treatment for rulemaking

purposes of secondary references

contained in the DCD. At issue is the

extent to which references to codes,

standards, Regulatory Guides, etc. need

to be explicitly ‘‘incorporated by

reference’’ in specific design

certification rules (DCRs). It is

industry’s position that the burden of

incorporating these secondary

references into the rule would outweigh

the increase in regulatory certainty and

predictability that such an effort would

provide. The second issue relates to the

regulatory significance of information

contained in the DCD and, in particular,

design Probabilistic Risk Assessment

(PRA) information. Specifically, NEI is

concerned with the inclusion of the

design PRA in the DCD and a perceived

requirement to use the PRA to support

the ‘‘50.59-like’’ change process.

Response. As defined in SECY–92–

287, the DCD is the master document

that contains the Tier 1 and 2

information referenced by the design

certification rule. The NRC staff has had

several meetings with the design

certification applicants on the

preparation of a DCD and provided

guidance to the applicants in letters

dated August 26, 1993; August 3 and 5,

1994; and October 4, 1994. Although the

Commission agrees with NEI on the

basic form of the DCD, it does not agree

with NEI’s proposed algorithm on the

contents of a DCD.

Because the DCD is the master

reference document, it should, to the

extent possible, retain as much of the

applicant’s standard safety analysis

report (SSAR), as required in 10 CFR

52.47. Due to the requirement that all

information incorporated in the rule be

publicly available, proprietary and

safeguards information cannot be

included in the DCD. Also, the NRC

concluded that the detailed

methodology and quantitative portions

of the design PRA do not need to be

included in the DCD but the

assumptions, insights, and discussions

of PRA analyses must be retained in the

DCD. The NRC also decided that COL

applicants and licensees will be

encouraged, but not required, to use the

PRA to support the change process. This

position was predicated in part upon

NEI’s acceptance, in conceptual form, of

a future generic rulemaking that

requires a COL applicant or holder to

have a plant-specific PRA that updates

and supersedes the design PRA to

account for site-specific and detailed asbuilt aspects of the plant. The

Commission approved the requirement

for a plant-specific PRA in its SRM on

SECY–94–182, ‘‘Probabilistic Risk

Assessment (PRA) Beyond Design

Certification,’’ in approving the

development of a generic ‘‘Operational

Rule’’ that would apply to all COL

applicants and holders. The remainder

of the applicant’s SSAR, including all of

the assumptions, issue resolutions, and

safety analyses, should be retained in

the DCD.

With regard to NEI’s concern with

secondary references, the NRC staff met

with NEI on January 6, 1994, and issued

a letter to NEI on May 3, 1994, that
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documented an agreement with the

industry on the resolution of this issue.

The agreement states that combined

license (COL) applicants and licensees

who reference a DCR will treat these

secondary references as requirements, in

the context that they are described in

the documents referenced in the DCD.

However, these secondary references

will not be incorporated by reference in

the DCR, and thus there is no issue

preclusion for secondary references.

With the above stated guidance, the

NRC believes that the appropriate form

and content of a DCD has been defined.

III. Section-by-Section Discussion of

Design Certification Rule

Pursuant to 10 CFR part 52, subpart

B, the NRC has been working for some

time to develop a rule that will achieve

the Commission’s goals for standard

design certifications. Therefore, this

proposed rule seeks to achieve the early

resolution of safety issues and to

enhance the safety and reliability of

nuclear power plants. The Commission

also expects to achieve a more

predictable and stable licensing process

through the certification of standard

designs by rulemaking. An applicant for

a combined license (COL) that

references a design certification rule

(DCR) must meet the requirements in

the DCR and in the design control

document that is incorporated by

reference in the DCR.

The NRC staff’s first proposal of a

standard design certification rule was

provided in Enclosure 1 to SECY–92–

287, dated August 18, 1992. This

proposal was modified based on

Commission guidance, and an updated

version was published in appendix 2 to

the ANPR. The proposed rule in this

Federal Register notice has the same

basic form and content as the ANPR

version, but there has been some

reorganization of the contents. The

following discusses the purpose and key

aspects of each section of the rule and

also discusses issues raised on those

sections that are not covered in the

public comment summary. Changes

made to the ANPR version of the

proposed rule for the sake of clarity,

brevity, consistency, or organization are

not discussed below.

All references to the proposed rule are

to the provisions in proposed appendix

A to 10 CFR part 52.

A. Scope

The purpose of Section 1 of the

proposed rule entitled, ‘‘Scope,’’ is to

identify the standard plant design that

is to be approved by this design

certification rule. The applicant for

certification of the design is also

identified in this section. While the

design certification applicant does not

have special rights pursuant to this rule,

the implementation of 10 CFR 52.63(c)

depends on whether an applicant for a

COL contracts with the design

certification applicant to provide the

certified design. If the COL applicant

does not use the design certification

applicant to provide the design, then it

may have to meet the requirements in

10 CFR 52.63(c). Also, the proposed rule

imposes a requirement on the design

certification applicant in Section 9(a)(1).

Therefore, identification of the design

certification applicant is necessary to

implement this rule.

Because the requirements of 10 CFR

52.63(c) apply to an applicant for a COL,

the NRC proposes that this requirement

be added to 10 CFR part 52 of subpart

C, specifically to a new section 10 CFR

52.79(e). The NRC requests comments

on the desirability of making this

change to 10 CFR part 52 (refer to

Section IV).

B. Definitions

The terms Tier 1, Tier 2, and Tier 2*

are defined in Section 2, of the proposed

rule entitled ‘‘Definitions,’’ because

these concepts were not envisioned at

the time that 10 CFR part 52 was

developed. The design certification

applicants and the NRC used these

terms in implementing the two-tiered

rule structure that was proposed by

industry after the issuance of part 52

(refer to discussion on Topic #1). The

design control document (DCD) contains

both the Tier 1 and 2 information, along

with an introduction. After the issuance

of the ANPR, the phrase Tier 2* was

added to the list of definitions. Some of

the information in Tier 2 that requires

special treatment in the change process

was commonly referred to as Tier 2*

during the design review. Therefore, the

Commission believes that it would be

useful to define and use this phrase in

the proposed rule. Further information

on changes to or departures from

information in the DCD is provided

below in the discussion on Section 8,

‘‘Change Process.’’ The NRC requests

suggestions on other words or phrases

that may need to be defined in this rule

(refer to Section IV).

C. [Reserved]

The purpose of Section 3,

‘‘Information collection requirements,’’

in the proposed rule was originally

intended to provide the citation for the

control number which has been

assigned by the Office of Management

and Budget when it approved the

information collection requirements in

this rulemaking. Because this citation

has been placed in § 52.8, section 3 to

the rule is no longer necessary.

D. Contents of the Design Certification

Section 4 of the proposed rule

entitled, ‘‘Contents of the design

certification,’’ identifies the designrelated information that is incorporated

by reference into this rule (4(a)) and

includes some related provisions of the

proposed rule (4(b) and (c)). Both tiers

of design-related information have been

combined into a single document, called

the design control document (DCD), in

order to effectively control this

information and facilitate its

incorporation into the rule by reference

(refer to Topic #9 for discussion on the

DCD). The DCD was prepared to meet

the requirements of the Office of the

Federal Register (OFR) for

incorporation by reference (1 CFR part

51). Section 4(a) of this proposed rule

would incorporate the DCD by reference

upon approval of the Director, OFR. The

legal effect of incorporation by reference

is that the material is treated as if it were

published in the Federal Register. This

material, like any other properly issued

regulation, has the force and effect of

law.

An applicant for a construction

permit or COL that references this

design certification rule must conform

with the requirements in the proposed

rule and the DCD. The master DCD for

this design certification will be archived

at NRC’s central file with a matching

copy at OFR. Copies of the up-to-date

DCD will also be maintained at the

NRC’s Public Document Room and

library. Questions concerning the

accuracy of information in an

application that references this design

certification will be resolved by

checking the master DCD in NRC’s

central file. If a generic change

(rulemaking) is made to the DCD

pursuant to the change process in

Section 8 of the proposed rule, then at

the completion of the rulemaking the

NRC will change its copies of the DCD

and notify the OFR and design

certification applicant to change their

copies.

The applicant for this design

certification rule is responsible for

preparing the DCD in accordance with

NRC and OFR requirements and

maintaining an up-to-date copy

pursuant to Section 9(a)(1) of the

proposed rule. Plant-specific changes to

and departures from the DCD will be

maintained by the applicant or licensee

that references this design certification

pursuant to Section 9(a)(2) of the

proposed rule. In order to meet the

requirements of OFR for incorporation

by reference, the originator of the DCD
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(design certification applicant) must

make the document available upon

request after the final design

certification rule is issued. Therefore,

the proposed rule states that copies of

the DCD can be obtained from the

applicant or an organization designated

by the applicant. The applicant for this

design certification has stated that it

plans to request distribution of its DCD

by the National Technical Information

Service (NTIS). If the applicant selects

an organization, such as NTIS, to

distribute the DCD, then the applicant

must provide that organization with an

up-to-date copy. A copy of the DCD

must also be made available at the NRC

and OFR.

The DCD contains an introduction

that explains the purpose and uses of

the DCD and two tiers of design-related

information. The significance of

designating design information as Tier 1

or Tier 2 is that different change

processes and criteria apply to each tier,

as explained in Section H ‘‘change

process’’ below. The introduction to the

DCD is neither Tier 1 nor Tier 2

information, and is not part of the

information in the DCD that is

incorporated by reference into this

design certification rule. Rather, the

DCD introduction constitutes an

explanation of requirements and other

provisions of this design certification

rule. If there is a conflict between the

explanations in the DCD introduction

and the explanations of this design

certification rule in these statements of

consideration (SOC), then this SOC is

controlling.

The Tier 1 portion of the designrelated information contained in the

DCD is certified by this rule. This

information consists of an introduction

to Tier 1, the certified design

descriptions and corresponding

inspections, tests, analyses, and

acceptance criteria (ITAAC) for systems

and structures of the design, design

material applicable to multiple systems

of the design, significant interface

requirements, and significant site

parameters for the design. The NRC

staff’s evaluation of the Tier 1

information, including a description of

how this information was developed is

provided in Section 14.3 of the FSER.

The information in the Tier 1 portion

of the DCD was extracted from the

detailed information contained in the

application for design certification. The

Tier 1 information addresses the most

safety-significant aspects of the design,

and was organized primarily according

to the structures and systems of the

design. Additional design material and

related ITAAC is also provided in Tier

1 for selected design and construction

activities that are applicable to multiple

systems of the design. The Tier 1 design

descriptions serve as design

commitments for the lifetime of a

facility referencing the design

certification, and the ITAAC verify that

the as-built facility conforms with the

approved design and applicable

regulations. In accordance with 10 CFR

52.103(g), the Commission must find

that the acceptance criteria in the

ITAAC are met before operation. After

the Commission has made the finding

required by 10 CFR 52.103(g), the

ITAAC do not constitute regulatory

requirements for subsequent

modifications. However, subsequent

modifications to the facility must

comply with the Tier 1 design

descriptions, unless changes are made

in accordance with the change process

in Section 8 of this proposed rule.

The Tier 1 interface requirements are

the most significant of the interface

requirements for the standard design,

which were submitted in response to 10

CFR 52.47(a)(1)(vii), that must be met by

the site-specific portions of a facility

that references the design certification.

The Tier 1 site parameters are the most

significant site parameters, which were

submitted in response to 10 CFR

52.47(a)(1)(iii), that must be addressed

as part of the application for a

construction permit or COL.

Tier 2 is the portion of the designrelated information contained in the

DCD that is approved by this rule but is

not certified. Changes to or departures

from the certified design material (Tier

1) must comply with Section 8(a) of this

proposed rule. Changes to or departures

from the approved information (Tier 2)

must comply with Section 8(b) of this

proposed rule. Tier 2 includes the

information required by 10 CFR 52.47

and supporting information on the

inspections, tests, and analyses that will

be performed to demonstrate that the

acceptance criteria in the ITAAC have

been met. Compliance with the more

detailed Tier 2 information provides a

sufficient method, but not the only

acceptable method, for complying with

the more general design requirements

included in Tier 1. A supplementary

description of Tier 2 information is

provided in the DCD introduction. If an

applicant or licensee used methods

other than those described in Tier 2,

then the alternative method would be

open to staff review and a possible

subject for a hearing.

When completing the design

information for a plant, an applicant for

a COL must conform with all of the

requirements in the DCD, unless the

information in the DCD is changed

pursuant to the process in Section 8 of

this proposed rule. The change process

defines the procedural differences

between Tier 1 and 2. Accordingly, an

applicant for a construction permit or

COL, or licensee that references this

certified design must conform with all

of the requirements from the DCD,

including the codes, standards, and

other guidance documents that are

referenced from the DCD (so-called

secondary references). The industry

agreed to treat these secondary

references as requirements even though

they are not incorporated by reference,

in the context as described in the DCD,

as set forth in a letter from Dennis

Crutchfield of the NRC to Joe Colvin of

the Nuclear Energy Institute, dated May

3, 1994.

An applicant for a construction

permit or COL that references this

proposed rule must also describe those

portions of the plant design which are

site-specific, and demonstrate

compliance with the interface

requirements, as required by 10 CFR

52.79(b). The COL applicant does not

need to conform with the conceptual

design information in the DCD that was

provided by the design certification

applicant in response to 10 CFR

52.47(a)(1)(ix). The conceptual design

information, which are examples of sitespecific design features, was required to

facilitate the design certification review,

and it is neither Tier 1 nor 2. The

introduction to the DCD identifies the

location of the conceptual design

information and explains that this

information is not applicable to a COL

application.

An applicant must address COL

Action Items, which are identified in

the DCD as COL License Information, in

its COL application. The COL Action

Items (COL License Information)

identify matters that need to be

addressed by an applicant or licensee

that references the design certification,

as required by 10 CFR 52.77 and 52.79.

A further explanation of the status of the

COL License Information is provided in

the DCD introduction. Also, the detailed

methodology and quantitative portions

of the design-specific probabilistic risk

assessment (PRA), as required by 10

CFR 52.47(a)(1)(v), was not included in

the DCD. The NRC agreed with the

design certification applicant’s request

to delete this information because

conformance with the deleted portions

of the PRA is not required. The NRC’s

position is also predicated in part upon

NEI’s acceptance, in conceptual form, of

a future generic rulemaking that

requires a COL applicant or licensee to

have a plant-specific PRA that updates

and supersedes the design-specific PRA
17910 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

and maintain it throughout the

operational life of the plant.

The application for design

certification contained proprietary and

safeguards information. This

information was part of the NRC staff’s

bases for its safety findings in the FSER.

However, because of OFR requirements,

this information could not be included

in the DCD. Therefore, the proprietary

and safeguards information, or its

equivalent, that was provided in the

design certification application but not

included in the DCD, must be included

as part of a COL application. The NRC

considers this information to be

requirements for plants that reference

this rule. Since this information was not

included in the DCD or otherwise

approved by OFR for ‘‘incorporation by

reference,’’ it would not have issue

preclusion in a construction permit or

COL proceeding.

There is other information that is

within the scope of the certified design

(i.e. as-built, as-procured, and evolving

technology design information) that

must be developed by a COL applicant

or holder. This detailed design

information must be completed in

accordance with the requirements in the

DCD and the acceptance criteria in

ITAAC, including DAC. Since the Tier

1 and 2 information is solely contained

within the DCD, the remainder of the

design-related information that is

developed by a COL applicant or holder

that references this proposed rule will

not be either Tier 1 or 2 information,

whether it is within the scope of the

design certification or not. Therefore,

the change process in Section 8 of this

proposed rule will not control this COL

information. Although the change

process for this COL information does

not need to be developed until a COL

application is submitted, the NRC is

interested in the public’s view on how

this information should be controlled

(refer to Section IV).

The purpose of Section 4(b) of this

proposed rule is to ensure that an

applicant that references this design

certification references both tiers of

information in the DCD. The two tiers

of information were developed together

and both tiers of information are needed

to complete the design of a plant that

references the rule. For example, the

ITAAC in Tier 1 contains not only the

acceptance criteria for verifying that the

as-built plant conforms with the

approved design, but it also contains

various design processes with

acceptance criteria (DAC), for

completing selected areas of the plant

design. The DAC are described in

Section 14.3 of the SSAR and FSER. The

NRC staff relied on DAC for its

evaluation of selected design areas

where the applicant for design

certification did not provide complete

design information. Also, the Tier 2

information contains explanations and

procedures on how to implement

ITAAC. Therefore, the Commission

proposes that an applicant could not

reference this design certification rule

without meeting ITAAC, even though it

is not a requirement in 10 CFR part 50

(See Section J for further discussion).

The applicant for design certification

initially prepared the DCD to be

consistent with the SSAR and the NRC

staff’s FSER. The applicant for design

certification made some corrections and

clarifications to the DCD since the

completion of the SSAR and issuance of

the FSER. If there is an inconsistency

between the SSAR and the FSER, or

between either of these documents and

the DCD, then the DCD is the controlling

document. That is the purpose of

Section 4(c) of this proposed rule.

E. Exemptions and Applicable

Regulations

The purpose of Section 5 of the

proposed rule entitled, ‘‘Exemptions

and applicable regulations,’’ of the

proposed rule is to identify the

complete set of regulations that were

applicable and in effect at the time the

design certification was issued for the

purposes of 10 CFR 52.48, 52.54, 52.59,

and 52.63. In accordance with 10 CFR

52.48, the NRC staff used the technically

relevant regulations (safety standards) in

10 CFR parts 20, 50, 73, and 100 in

performing its review of the application

for design certification. The effective

date of the applicable regulations is the

date of the FSER, as set forth in Section

5(b) of the proposed rule. During its

review of the application for design

certification, the NRC staff identified

certain regulations for which

application of the regulation to the

standard design would not serve or was

not necessary to achieve the underlying

purpose of the regulation. These

proposed exemptions to the NRC’s

current regulations are identified in

Section 5(a) of this proposed rule. The

basis for these exemptions is provided

in the FSER.

In implementing the goals of 10 CFR

part 52 and the Commission’s Severe

Accident Policy Statement, the NRC

staff set out to achieve a higher level of

safety performance for both

evolutionary and passive LWR standard

designs in the area of severe accidents

and in other selected areas. As a result,

the NRC staff proposed new

requirements in various Commission

papers, such as SECY–90–016 and

SECY–93–087, to be used in the design

certification review and treated as

applicable regulations in the design

certification rulemaking (refer to

discussion on Topic #8). The bases for

these requirements are set forth in

SECY–90–016 and SECY–93–087. The

Commission approved the use of these

proposed regulations for purposes of the

design certification review in the

respective SRMs. These proposed

regulations deviated from or were not

embodied in current regulations

applicable to the standard design. The

NRC staff then selected proposed

regulations that were applicable to the

design under review and reviewed the

design pursuant to these applicable

regulations. The FSER identifies the

applicable regulations that were used

and describes how these regulations

were met by the design-related

information in the SSAR. The

Commission approved the evaluation of

the design pursuant to the applicable

regulations in its approval to publish

the FSER.

These proposed applicable

regulations are identified in Section 5(c)

of this proposed rule to achieve

codification through the design

certification rulemaking. The proposed

applicable regulations in Section 5(c)

are substantively the same as those in

the FSER but have been edited for

clarity. These codified requirements,

which supplement the regulations in

Section 5(b), will become part of the

Commission’s regulations that were

‘‘applicable and in effect at the time the

certification was issued,’’ if the

Commission adopts them in the final

design certification rule. The

Commission requests comments on

whether each specific applicable

regulation is justified (refer to Section

IV).

The codification of these additional

requirements, in reference to 10 CFR

52.48, is necessary for two reasons.

First, it serves as a basis for obtaining

public comment on the adoption of the

proposed requirements as applicable

regulations. Second, it provides

confirmation that the requirements are

being adopted by the Commission as

applicable regulations under § 52.54 for

the design certification being approved.

In the absence of this codification, a

design certification applicant could

argue that the Commission cannot

lawfully condition approval of the

design certification on compliance with

the requirements used during its review

of the design. This is because the

proposed requirements, without further

Commission action, could be argued as

not being ‘‘applicable standards and

requirements of the * * *

Commission’s regulations’’ under
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17911

2This change process has been reorganized for

clarity and conformance to the two-tiered rule

structure, and to distinguish between generic

changes to Tier 1 and 2 information, which are

accomplished via rulemaking, and plant-specific

departures from Tier 1 and 2 information, which

may be accomplished by the process defined in

Section 8 of this proposed rule. For brevity, this

SOC refers to both aspects as constituting the

‘‘change process’’ for this design certification rule.

§ 52.54. Also, without codification of

the applicable regulations, the NRC

could not perform its reviews in

accordance with §§ 52.59 and 52.63. By

codifying these requirements, the NRC

intends that for renewal of a certified

design under § 52.59, these

requirements are part of the applicable

regulations in effect at the time that the

design certification was first issued.

The Commission may, pursuant to

§ 53.63(a)(1) and (3), impose a

modification of Tier 1 information or

issue a plant-specific order,

respectively, to ensure that the certified

design or the plant complies with the

applicable regulations of the design

certification rule. The rationale is that

the Commission could not, without rereviewing the merits of each position,

impose a change to Tier 1 information

or issue a plant-specific order merely

because the modification was necessary

for compliance with a matter involving

these requirements. Also, the

Commission would not have a complete

list of regulations for use in evaluating

requested changes from the public,

applicants, or licensees, thereby

degrading the predictability of the

licensing process.

By identifying the regulations that are

applicable to each design, the

Commission has improved the stability

and predictability of the licensing

process. By approving the design

information that describes how these

regulations were met, the Commission

has minimized the potential for a

differing interpretation of the

regulations. Finally, the NRC rejected

NEI’s proposed alternative to applicable

regulations in a meeting on April 25,

1994 and in a letter dated July 25, 1994.

NEI’s proposal to use design

information as a surrogate for designspecific (applicable) regulations is not

workable for proposed changes, because

the design information only represents

one way of implementing a regulation.

The NRC would need the regulation for

the design feature in order to evaluate

a proposed change to the design

information.

F. Issue Resolution for the Design

Certification

The purpose of Section 6 of the

proposed rule entitled, ‘‘Issue resolution

for the design certification’’ is to

identify the issues that are considered

resolved, if the Commission adopts a

final design certification rule, and

therefore, these issues receive issue

preclusion within the scope and intent

of 10 CFR 52.63(a)(4). Specifically, all

nuclear safety issues arising from the

Atomic Energy Act that are associated

with the information in the NRC staff’s

FSER or the applicant’s DCD are

resolved within the meaning of

§ 52.63(a)(4). All issues arising under

the National Environmental Policy Act

of 1969 associated with the information

in the NRC staff’s environmental

assessment or the severe accident design

alternatives in the applicant’s Technical

Support Document are also resolved

within the scope and intent of

§ 52.63(a)(4). The issues that are

associated with information that is not

included in the DCD, such as

proprietary information, do not have

issue preclusion within the meaning of

10 CFR 52.63(a)(4).

G. Duration of the Design Certification

The purpose of Section 7 of the

proposed rule entitled, ‘‘Duration of the

design certification,’’ is in part to

specify the time period during which

the standard design certification may be

referenced by an applicant for a

construction permit or COL, pursuant to

10 CFR 52.55. This section of the rule

also states that the design certification

remains valid for an applicant or

licensee that references the design

certification until their application is

withdrawn or their license expires.

Therefore, if an application references

this design certification during the 15-

year period, then the design certification

rule continues in effect until the

application is withdrawn or the license

issued on that application expires. Also,

the design certification continues in

effect for the referencing license if the

license is renewed. The Commission

intends for the proposed rule to remain

valid for the life of the plant that

references the design certification to

achieve the benefits of standardization

and licensing stability. This means that

rulemaking changes to or plant-specific

departures from information in the DCD

must be made pursuant to the change

process in Section 8 of this proposed

rule for the life of the plant.

H. Change Process

The purpose of Section 8 of the

proposed rule entitled, ‘‘Change

Process’’ is to set forth the process for

requesting rulemaking changes to or

plant-specific departures from

information in the DCD. The

Commission has developed a more

restrictive change process than for

plants that were licensed pursuant to 10

CFR part 50, in order to achieve a more

stable licensing process for applicants

and licensees that reference a design

certification rule. The change process in

Section 8 is substantively the same as

the process proposed in the ANPR.2 As

a result, Section 8(a) provides the

process for changing Tier 1 information

and Section 8(b) provides the process

for changing Tier 2 information. The

change process for Tier 1 information

uses the change process developed by

the Commission in the 10 CFR part 52

rulemaking for certified design-related

information. Therefore, the provisions

in Section 8(a) of the proposed rule

simply refer to the appropriate sections

in 10 CFR 52.63. A description of the

Tier 1 information that is controlled by

Section 8(a) is provided in the above

discussion on contents of the design

certification (III.D).

As discussed in Topic #2, the NRC

developed a change process for Tier 2

that has the same elements as the Tier

1 change process. Specifically, the Tier

2 change process in Section 8(b) has

provisions for generic changes, plantspecific orders, and exemptions similar

to those in 10 CFR 52.63, but some of

the standards for plant-specific orders

and exemptions are different. The

standards that must be met in order to

justify a generic change to either Tier 1

or 2 information are the same. When

NEI proposed a two-tiered structure for

design certification rules in its letter of

August 31, 1990, it also stated that

‘‘NRC backfits involving matters

described in the first tier would be

governed by the provisions of § 52.63,

whereas § 50.109 would govern

backfitting as respects the second tier.’’

As a result, the NRC staff used the

backfit standards in § 50.109 for generic

changes to Tier 2 in its proposed design

certification rule in SECY–92–287.

Subsequently, in a letter dated October

5, 1992, NEI changed its position and

agreed with the Commission that the

standard for generic changes to Tier 2

should be the same as the Tier 1

standard. This issue is discussed further

in SECY–92–287A, dated March 26,

1993. Therefore, Section 8 of this

proposed rule uses the same standards

for generic changes to both Tier 1 and

2 information.

Although the process in Section 8 for

plant-specific orders and exemptions is

the same for Tier 1 and 2 information,

the standards are different. In order to

preserve the benefits of standardization

which is one of the important goals of

design certification, the Commission
17912 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

proposes in Section 8(a)(3) that plantspecific orders or exemptions from Tier

1 information must consider whether

the special circumstances which

§ 50.12(a)(2) required to be present

outweigh any decrease in safety that

may result from the reduction in

standardization, as required in 10 CFR

52.63(a)(3). The Commission does not

propose to adopt this additional

consideration for plant-specific orders

or exemptions from Tier 2 information,

in order to achieve additional flexibility.

The Commission believes this is

acceptable because the Tier 2

information is not as safety significant

as the Tier 1 information. Therefore,

Sections 8(b) (3) and (4) of the proposed

rule do not require the additional

consideration of the reduction in

standardization caused by proposed

departures from Tier 2 information.

A generic change to either Tier 1 or

2 information in the DCD is

accomplished by rulemaking. Any

person seeking to make a generic change

to the DCD, including the applicant for

this design certification, must submit a

petition pursuant to 10 CFR 2.802. This

petition must describe how the

proposed change meets the standards in

10 CFR 52.63(a)(1) for justifying a

generic change to the DCD. Any generic

changes to the DCD resulting from the

rulemaking will be noticed in the

Federal Register. The NRC will update

the master DCD in its central files and

the copies in the NRC Library and

public document room (refer to the

discussion in III.D). Under Sections 8(a)

(2) and (b)(2) generic changes to Tier 1

and 2, respectively, will be applicable to

all plants referencing the design

certification. However, if the NRC

determines that a generic change is not

technically relevant to a particular

plant, based on plant-specific changes

made pursuant to Section 8, then the

generic rulemaking will indicate that

the change will not be applicable to that

plant. If the proposed change to the DCD

also results in a violation of an

underlying regulation that is applicable

to this design certification, then an

exemption to that regulation is also

required.

A plant-specific departure from either

Tier 1 or 2 information in the DCD does

not require rulemaking. Any person

requesting a Commission order directing

a plant-specific change, including the

applicant for this design certification,

must submit a petition pursuant to 10

CFR 2.206. This petition must describe

how the proposed change meets the

standards in 10 CFR 52.63(a)(3) or

Section 8(b)(3) for departures from Tier

1 or Tier 2 information, respectively. By

contrast an applicant or licensee that

references this design certification rule

may request exemptions from Tier 1 or

2 information pursuant to 10 CFR

52.63(b)(1) or Section 8(b)(4) of this

rule, respectively. The NRC recognized

that there may be special circumstances

pertaining to a particular applicant or

licensee that would justify an

exemption from the DCD. The request

must describe how the exemption from

Tier 1 or 2 meets the standards in 10

CFR 52.63(b)(1) or Section 8(b)(4) of this

proposed rule, respectively. The

exemption may be contested in a

hearing if the exemption is granted in

connection with issuance of a

construction permit, operating license,

or combined license; it may also be

contested in a hearing if the exemption

also requires the issuance of a license

amendment. If a plant-specific change

or exemption from the DCD also results

in a violation of the underlying

regulation that is applicable to this

design certification, then an exemption

to that regulation is also required.

In addition to the plant-specific

changes described above, an applicant

or licensee that references this design

certification rule may depart from Tier

2 information, without prior NRC

approval pursuant to Section 8(b)(5) of

this proposed rule. However, the

Commission believes that these changes

should open the possibility for

challenge in a hearing (refer to

discussion on Topic #2). The

Commission approved the use of this

‘‘§ 50.59-like’’ change process in its

SRMs on SECY–90–377 and SECY–92–

287A. The NRC is interested in the

public’s view on how these changes

could be challenged in a hearing (refer

to Section IV).

As in 10 CFR 50.59, an applicant or

licensee cannot make changes that

involve an unreviewed safety question

(USQ) or technical specifications,

without prior NRC approval. Also, for

changes pursuant to Section 8(b)(5), an

applicant or licensee cannot make

changes to Tier 1 or Tier 2* information

without prior NRC approval. If the

proposed change does not involve these

factors, then the NRC will allow changes

to previously approved information in

Tier 2 without prior NRC approval.

However, if the change involves an

issue that the NRC staff has not

previously approved, then NRC

approval is required. The process for

evaluating proposed tests or

experiments not described in Tier 2 will

be developed for an operating or

combined license that references this

design certification (refer to Section IV).

The restriction on changing Tier 1

information is included in the process

in Section 8(b)(5) because this

information can only be changed

pursuant to Section 8(a) of the proposed

rule. Whereas, the restriction on

changing Tier 2* information resulted

from the development of the Tier 1

information in the DCD. A description

of the Tier 1 information is provided in

the discussion in Section III.D on

contents of the design certification.

During the development of the Tier 1

information, the applicant for design

certification requested that the amount

of information in Tier 1 be minimized

to provide additional flexibility for the

applicant or licensee that references this

design certification. Also, many codes,

standards, and design processes, which

were not specified in Tier 1, that are

acceptable for meeting ITAAC were

specified in Tier 2. The result of these

actions is that certain relatively

significant information only exists in

Tier 2 and the NRC staff did not want

this significant information changed

without prior NRC approval. The NRC

specified this information in its FSER

and the design certification applicant

has identified this information in its

DCD. This information has come to be

known as Tier 2* information and it has

compensated for industry’s desire to

minimize the amount of information in

Tier 1.

In the ANPR, the NRC referred to the

Tier 2* information as pre-identified

unreviewed safety questions (USQs)

because there was already an

established procedure in 10 CFR 50.59

for FSAR changes that constitute USQs,

which require NRC approval. NEI stated

in its comments on the ANPR that it was

not necessary to create an artificial set

of USQs in order to accomplish the

NRC’s objective of requiring prior

approval. Therefore, the proposed rule

was changed from the ANPR to simply

state that the Tier 2* information can

not be changed without prior NRC

approval. Also, NEI requested in its

comments that the Tier 2* information

not be identified in the design

certification rule, as was proposed in

the ANPR, and that an expiration date

be considered for the restriction in the

change process for Tier 2* information.

NRC agrees that Tier 2* information can

be identified in the DCD and Section

8(b)(5) of the proposed rule was

changed accordingly. The NRC also

reevaluated the duration of the change

restriction for Tier 2* information and

determined that some of the Tier 2*

information can expire when the plant

first achieves 100% power while other

Tier 2* information must remain in

effect throughout the life of the plant

that references the DCR. The DCD sets
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17913

forth an expiration date for some of the

Tier 2* information.

As part of this rulemaking, the NRC

is seeking public comments on the

appropriate regulatory process to use for

review of proposed changes to Tier 2*

information. Currently, pursuant to 10

CFR 50.59, the NRC approves changes to

FSAR information that constitute a USQ

or involve technical specifications

through the issuance of license

amendments. However, if an applicant

or licensee requests NRC approval for a

proposed change to Tier 2* information,

should the NRC review process be

similar to that for a USQ? While it is

clear that these proposed changes would

all involve significant design-related

information and that prior review of

proposed departures from Tier 2*

information is necessary, the NRC has

not determined if it is always

appropriate to process the approved

changes as either an amendment to the

license application or an amendment to

the license, with the requisite hearing

rights. Therefore, the NRC requests the

public’s view on the preferred

regulatory process for these changes

(refer to Section IV).

An applicant or licensee that plans to

depart from Tier 2 information,

pursuant to Section 8(b)(5), must

prepare a safety evaluation which

provides the bases for the determination

that the proposed change does not

involve an unreviewed safety question,

a change to Tier 1 or Tier 2*

information, or a change to the technical

specifications. In order to achieve the

Commission’s goals for design

certification, the evaluation needs to

consider all of the matters that were

resolved in the DCD, including the

generic issues discussed in Chapter 20

of the FSER. The benefits of the early

resolution of safety issues would be lost

if changes were made to the DCD that

violated these resolutions without NRC

approval. The evaluation of the resolved

issues needs to consider the proposed

change over the full range of power

operation from startup to shutdown,

including issues resolved under the

heading of shutdown risk, as it relates

to anticipated operational occurrences,

transients, and design basis accidents.

The evaluation should consider the

tables in Sections 14.3 and 19.8 of the

DCD to ensure that the proposed change

does not impact Tier 1. These tables

contain various cross-references from

the plant safety analyses in Tier 2 to the

important parameters that were

included in Tier 1. Although many

issues and analyses could have been

cross-referenced, the listings in these

tables were developed only for key plant

safety analyses for the design. GE

provided more detailed cross-references

to Tier 1 for these analyses in a letter

dated March 31, 1994, and ABB–CE

provided more detailed cross-references

in a letter dated June 10, 1994. The NRC

does not endorse NSAC–125,

‘‘Guidelines for 10 CFR 50.59 Safety

Evaluations,’’ for performing the safety

evaluations required by Section 8(b)(5)

of the proposed rule. However, the NRC

will work with industry, if it is desired,

to develop an appropriate guidance

document for implementing Section 8

after the final rule is issued.

During the review of its DCD, GE

requested that the determination of

whether a proposed departure from Tier

2 information that involves severe

accident issues constitutes a USQ use

criteria that are different from the

criteria for USQ determinations

proposed in the ANPR (10 CFR

50.59(a)(2)). GE argued that not all

increases in the probability or

consequences of severe accidents are

significant from a safety standpoint.

Minor increases in the probability of

some accident scenarios will not affect

the overall core damage frequency or the

conclusions of the severe accident

evaluations. Therefore, GE proposed

that changes to Tier 2 information that

result in insignificant increases in the

probability or consequences of severe

accidents not constitute a USQ.

The NRC believes that it is important

to preserve and maintain the resolution

of severe accident issues just like all

other safety issues that were resolved

during the design certification review

(refer to SRM on SECY–90–377).

However, because of the increased

uncertainty in severe accident issue

resolutions, the NRC has proposed, in

Section 8(b)(5), separate criteria for

determining whether a departure from

information associated with severe

accident issues constitutes a USQ. The

new criteria in Section 8(b)(5)(iii) will

only apply to Tier 2 information that is

associated with the severe accident

issues discussed in the section of the

DCD identified in the rule. The criteria

for USQ determinations in Section

8(b)(5)(ii), which are the same as those

proposed in the ANPR, will apply to

other Tier 2 information. If the proposed

departure from Tier 2 information

involves the resolution of other safety

issues in addition to the severe accident

issues, then the USQ determination

should be based upon the criteria in

Section 8(b)(5)(ii). The NRC is interested

in the public’s view on whether the Tier

2 information involving resolutions of

severe accident issues should be treated

differently for USQ determinations than

all other safety issues? If so, are the

proposed criteria in Section 8(b)(5)(iii)

sufficient to determine if a proposed

departure from information associated

with severe accident issues constitutes a

USQ? (Refer to Section IV).

The NRC is also proposing two

additional provisions to the change

process that were not in the ANPR. The

first is Section 8(b)(5)(iv), which

provides that changes made pursuant to

Section 8(b)(5) do not also require an

exemption from the design certification

rule. Because the Tier 2 information is

incorporated by reference into the

design certification, a departure from

Tier 2 pursuant to Section 8(b)(5) would

also require an exemption from the

design certification rule absent this

proposed provision. The second

provision is Section 8(c), which makes

it clear that proposed changes to

requirements in this design certification

rule that are neither Tier 1 nor Tier 2

must be done by exemption pursuant to

10 CFR 50.12. Such requirements

include the recordkeeping and reporting

requirements in Section 9 of this

proposed rule.

I. Records and Reports

The purpose of Section 9 of this

proposed rule entitled, ‘‘Records and

Reports,’’ is to set forth the requirements

for maintaining records of DCD changes

and submitting reports to the NRC. This

section is similar to the requirements for

records and reports in 10 CFR part 50

and § 52.63(b)(2), with the following

differences. Section 9(a)(1) requires an

applicant for design certification to

maintain an up-to-date copy of the DCD

that includes all generic changes to Tier

1 and 2 information that are made by

rulemaking. This will ensure that the

design certification applicant provides

up-to-date versions of the DCD to

prospective applicants that want to

reference this design certification or to

other interested parties who want copies

of the DCD. Section 9(a)(2) requires an

applicant or licensee that references this

design certification to maintain an upto-date plant-specific version of the DCD

that includes both generic changes to

the DCD, as well as plant-specific

departures from the DCD. This ensures

that the plant records which include an

accurate DCD reflecting information

specific to the plant as well as changes

to the DCD.

The proposed rule also establishes

reporting requirements in Section 9(b)

for applicants or licensees that reference

this design certification rule. The

requirements in Section 9(b) are similar

to the reporting requirements in 10 CFR

part 50, except that they include

reporting of changes to or departures

from the plant-specific DCD. In

addition, the reporting requirements in
17914 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

Section 9(b) vary according to whether

the changes are made as part of an

application, during plant construction,

or during operation. Also, the reporting

frequency of summary reports of

departures from and periodic updates to

the DCD increases during plant

construction. If an applicant that

references this design certification rule

decides to adopt departures from the

DCD that were developed, but not

approved pursuant to Section 8 of this

proposed rule, before its application

(i.e., first of a kind engineering), then

the proposed departures from the DCD

must be submitted with the initial

application for a construction permit or

combined license.

For currently operating plants, a

licensee is required to maintain records

of the basis for any design change made

to the plant pursuant to 10 CFR 50.59.

Further, a licensee is required to

provide a summary of these changes to

the NRC annually or along with updates

to the final safety analysis report

pursuant to 10 CFR 50.71. The proposed

rule allows departures from the DCD

during the periods of application,

construction, and operation of the plant.

Therefore, the proposed rule requires

timely submittal of summary reports of

departures from, as well as updates to,

the DCD during each of these intervals,

consistent with the Commission’s

guidance on reporting frequency in its

SRM on SECY–90–377.

NEI proposed reporting of design

changes at a 6-month interval, in its

comments on the ANPR, to ‘‘avoid

unnecessarily diverting owner/operator

resources to meet excessive reporting

requirements.’’ The NRC modified the

provisions in the proposed rule to relax

the reporting requirements before

issuance of a construction permit or

combined license. During this interval,

summary reports of changes and

updates to the DCD should be submitted

to the NRC as part of the amendments

to the construction permit or combined

license application. However, the NRC

does not agree with the NEI proposal for

semi-annual reporting of design changes

during plant construction because it

does not provide for sufficiently timely

notification of design changes.

Therefore, the Commission retained the

requirement for quarterly reporting of

changes in the proposed rule during this

interval. Also, the NRC relaxed the

provisions in Section 9(b) so that during

operation of a plant, the reporting

requirements are the same as for

currently operating plants.

The NRC Commission believes that

quarterly reporting of design changes

during the period of construction are

necessary to closely monitor the status

and progress of the construction of the

plant. As required by 10 CFR 52.99, the

NRC must find that the ITAAC have

been successfully met. The ITAAC

verify that the as-built facility conforms

with the approved design and

emphasize design reconciliation and

design verification of the as-built plant.

To make its finding, the NRC must tailor

its inspection program to monitor the

plant construction and adjust its

program to accommodate changes.

Quarterly reporting of design changes

will facilitate these adjustments in a

timely manner and aids in a common

understanding of the plant as the

changes are being made. This is

particularly important in times where

the number of design changes could be

significant, such as during the

procurement of components and

equipment, detailed design of the plant

at the start of construction, and during

pre-operational testing.

Section 9(c) of the proposed rule

requires that records are kept for the

lifetime of a facility, as in 10 CFR part

50 and § 52.63(b)(2).

J. Applicability of a DCR in 10 CFR Part

50 Licensing Proceedings

Several provisions in 10 CFR part 52,

subpart B, suggest that design

certification rules (DCRs) may be

referenced not only in combined license

proceedings under 10 CFR part 52,

subpart C, but also in licensing

proceedings under 10 CFR part 50.

Section 52.63(c) states:

The Commission will require, prior to

granting a construction permit, combined

license, or operating license which references

a standard design certification, that

information normally contained in certain

procurement specifications and construction

and installation specifications be completed

and available for audit if such information is

necessary for the Commission to make its

safety determination, including the

determination that the application is

consistent with the certified design.

(Emphasis supplied.)

See also §§ 52.41, 52.55(b), 52.55(c),

52.63(a)(4), 52.63(b)(1). However, these

provisions in 10 CFR part 52, subpart B,

are inconsistent in identifying the type

of part 50 proceeding in which design

certification rules may be referenced.

For example, although § 52.63(c)

(quoted above) and § 52.55(c) explicitly

provide for referencing of design

certification rules in 10 CFR part 50

construction permit proceedings,

§§ 52.55(b), 52.63(a)(4) and 52.63(b)(1)

refer only to operating license

proceedings. Section 52.63(a)(4) is

illustrative:

Except as provided for in 10 CFR 2.758, in

making the findings required for issuance of

a combined license or operating license, or

for any hearing under § 52.103, the

Commission shall treat as resolved those

matters resolved in connection with the

issuance or renewal of a design certification.

(Emphasis supplied.)

Therefore, some might question

whether the Commission intended

construction permits applicants under

10 CFR part 50 to have the option of

referencing design certification rules.

However, the Commission has not

identified any regulatory or policy

reasons for precluding a construction

permit applicant from referencing a

design certification rule while allowing

an operating license applicant to do so.

Thus, the Commission believes that 10

CFR part 52 provides the discretion to

authorize a construction permit

applicant under 10 CFR part 50 to

reference a design certification rule.

Assuming that the Commission has

such discretion, there are a number of

issues that present themselves. Should

the Commission exercise its discretion

to allow construction permit applicants

to reference this design certification

rule? Should the Commission require

that if a design certification rule is to be

relied upon in part 50 licensing

proceedings, it must be referenced in

both the construction permit and

operating license applications? Would it

make sense to allow an operating

license applicant to reference a design

certification if the underlying

construction permit did not reference

the design certification? The

Commission recognizes that

consideration of these issues depends in

part upon the legal significance of a

design certification in the 10 CFR part

50 licensing proceeding, as well as its

significance for the permittee or licensee

once the construction permit or

operating license is granted. In

particular, 10 CFR part 52, subpart B,

does not say what the legal effect is (if

any) of ITAAC in a part 50 operating

license proceeding in which the

underlying construction permit

references a design certification.

In view of the status of ITAAC as Tier

1 information, how would a

construction permit applicant

referencing a design certification rule

avoid referencing the ITAAC? What

would be the consequences for the

construction permit applicant of

referencing ITAAC? If the underlying

construction permit referenced ITAAC,

then what (if any) would be the scope

and nature of ‘‘issue preclusion’’ at the

operating license stage, in terms of Staff/

Commission review and approval of the

operating license application, as well as

issues which are precluded from

consideration under 10 CFR 2.758? The
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17915

3An opportunity for public comment is required

by Section 553 of the Administrative Procedures

Act and 10 CFR 52.51(b).

Commission seeks the public’s views on

the referencing of design certification

rules in 10 CFR part 50 applications

(refer to Section IV).

IV. Specific Requests for Comments

In addition to the general invitation to

submit comments on the proposed rule,

the DCD, and the environmental

assessment, the NRC also invites

specific comments on the following

questions:

1. Should the requirements of 10 CFR

52.63(c) be added to a new 10 CFR

52.79(e)? (Refer to discussion in III.A.)

2. Are there other words or phrases

that should be defined in Section 2 of

the proposed rule? (Refer to discussion

in III.B.)

3. What change process should apply

to design-related information developed

by a COL applicant or holder that

references this design certification rule?

(Refer to discussion in III.D.)

4. Are each of the applicable

regulations set forth in Section 5(c) of

the proposed rule justified? (Refer to

discussion in III.E.)

5. Section 8(b)(5)(i) authorizes an

applicant or licensee who references the

design certification to depart from Tier

2 information without prior NRC

approval if the applicant or licensee

makes a determination that the change

does not involve a change to Tier 1 or

Tier 2* information, as identified in the

DCD, the technical specifications, or an

unreviewed safety question as defined

in Sections 8(b)(5)(ii) and (iii). Where

Section 8(b)(5)(i) states that a change

made pursuant to that paragraph will no

longer be considered as a matter

resolved in connection with the

issuance or renewal of a design

certification within the meaning of 10

CFR 52.63(a)(4), should this mean that

the determination may be challenged as

not demonstrating that the change may

be made without prior NRC approval or

that the change itself may be challenged

as not complying with the

Commission’s requirements? (Refer to

discussion in III.H.)

6. How should the determinations

made by an applicant or licensee that

changes may be made under Section

8(b)(5)(i) without prior NRC approval be

made available to the public in order for

those determinations to be challenged or

for the changes themselves to be

challenged? (Refer to discussion in

III.H.)

7. What is the preferred regulatory

process (including opportunities for

public participation) for NRC review of

proposed changes to Tier 2* information

and the commenter’s basis for

recommending a particular process?

(Refer to discussion in III.H.)

8. Should determinations of whether

proposed changes to severe accident

issues constitute an unreviewed safety

question use different criteria than for

other safety issues resolved in the

design certification review and, if so,

what should those criteria be? (Refer to

discussion in III.H.)

9(a) (1) Should construction permit

applicants under 10 CFR part 50 be

allowed to reference design certification

rules to satisfy the relevant

requirements of 10 CFR part 50? (Refer

to discussion in III.J.)

(2) What, if any, issue preclusion

exists in a subsequent operating license

stage and NRC enforcement, after the

Commission authorizes a construction

permit applicant to reference a design

certification rule?

(3) Should construction permit

applicants referencing a design

certification rule be either permitted or

required to reference the ITAAC? If so,

what are the legal consequences, in

terms of the scope of NRC review and

approval and the scope of admissible

contentions, at the subsequent operating

license proceeding?

(4) What would distinguish the ‘‘old’’

10 CFR part 50 2-step process from the

10 CFR part 52 combined license

process if a construction permit

applicant is permitted to reference a

design certification rule and the final

design and ITAAC are given full issue

preclusion in the operating license

proceeding? To the extent this

circumstance approximates a combined

license, without being one, is it

inconsistent with Section 189(b) of the

Atomic Energy Act (added by the

Energy Policy Act of 1992) providing

specifically for combined licenses?

9(b) (1) Should operating license

applicants under 10 CFR Part 50 be

allowed to reference design certification

rules to satisfy the relevant

requirements of 10 CFR part 50? (Refer

to discussion in III.J.)

(2) What should be the legal

consequences, from the standpoints of

issue resolution in the operating license

proceeding, NRC enforcement and

licensee operation if a design

certification rule is referenced by an

applicant for an operating license under

10 CFR Part 50?

(c) Is it necessary to resolve these

issues as part of this design certification,

or may resolution of these issues be

deferred without adverse consequence

(e.g., without foreclosing alternatives for

future resolution).

V. Comments and Hearings in the

Design Certification Rulemaking

A. Opportunity to Submit Written and

Electronic Comments

Any person may submit written

comments on the proposed design

certification rule to the Commission for

its consideration.3 Commenters have

120 days from the publication of this

notice to file written comments on the

proposed design certification rule.

Commenters needing access to

proprietary information in order to

provide written comments must follow

the procedures and filing deadlines

(including the date for filing written

comments) which are set forth in

Section V.E. below.

Commenters are encouraged to

submit, in addition to the original paper

copy, a copy of the comment letter in

electronic format on a DOS-formatted

(IBM compatible) 3.5 or 5.25-inch

computer diskette. Text files should be

provided in WordPerfect format or

unformatted ASCII code. The format

and version should be identified on the

diskette’s external label. Comments may

also be submitted electronically, in

either ASCII text or WordPerfect format

(version 5.1 or later), by calling the NRC

Electronic Bulletin Board on FedWorld.

The bulletin board may be accessed

using a personal computer, a modem,

and one of the commonly available

communications software packages, or

directly via Internet.

If using a personal computer and

modem, the NRC subsystem on

FedWorld can be accessed directly by

dialing the toll free number: 1–800–

303–9672. Communication software

parameters should be set as follows:

parity to none, data bits to 8, and stop

bits to 1 (N,8,1). Using ANSI terminal

emulation, the NRC rules subsystem can

then be accessed by selecting the

‘‘Rules’’ option from the ‘‘NRC Main

Menu.’’ For further information about

options available for NRC at FedWorld

consult the ‘‘Help/Information Center’’

from the ‘‘NRC Main Menu.’’ Users will

find the ‘‘FedWorld Online User’s

Guides’’ particularly helpful. Many NRC

subsystems and databases also have a

‘‘Help/Information Center’’ option that

is tailored to the particular subsystem.

The NRC subsystem on FedWorld can

also be accessed by a direct dial phone

number for the main FedWorld BBS:

703–321–3339; Telnet via Internet:

fedworld.gov (192.239.92.3); File

Transfer Protocol (FTP) via Internet:

ftp.fedworld.gov (192.239.92.205); and
17916 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

4An opportunity for a hearing is provided by 10

CFR 52.51(b).

5Filings discussed in this section may also be

served upon the Commission in electronic form in

lieu of express mail. However, parties must serve

copies of their filings on other parties by express

mail, unless the receiving party agrees to filing in

electronic form. Filings must be transmitted no later

than the last day of the time period specified for

filing and must be in accordance with the

requirements specified in the Summary.

World Wide Web using: http://

www.fedworld.gov (this is the Uniform

Resource Locator (URL)).

If using a method other than the toll

free number to contact FedWorld, then

the NRC subsystem will be accessed

from the main FedWorld menu by

selecting the ‘‘U.S. Nuclear Regulatory

Commission’’ option from FedWorld’s

‘‘Subsystems/Databases’’ menu or by

entering the command ‘‘/go nrc’’ at a

FedWorld command line. If NRC access

is obtained through FedWorld’s

‘‘Subsystems/Databases’’ menu, then

return to FedWorld is accomplished by

selecting the ‘‘Return to FedWorld’’

option from the ‘‘NRC Main Menu.’’

However, if NRC access at FedWorld is

accomplished by using NRC’s toll-free

number, access to all NRC systems is

available, but there will be no access to

the main FedWorld system. For more

information on NRC bulletin boards call

Mr. Arthur Davis, Systems Integration

and Development Branch, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555, telephone (301) 415–5780; email AXD3@nrc.gov.

Public Meeting

The NRC staff plans to conduct a

public meeting on this proposed rule on

May 11, 1995, at the NRC Auditorium

in Two White Flint North. Further

details on the meeting are provided in

a document published in this issue of

the Federal Register. The purpose of the

public meeting will be to discuss this

proposed rule and respond to questions

on the meaning and intent of any

provisions of this proposed rule. It is

hoped that this meeting will be helpful

to persons who intend to submit written

comments on the proposed rule. An

official transcript of the proceedings of

the public meeting will be prepared.

B. Opportunity to Request Hearing

Any person may request an informal

hearing on one or more specific matters

with respect to the proposed design

certification rule.4 An informal hearing

provides the admitted party with an

opportunity to provide written and oral

presentations on those matters to an

Atomic Safety and Licensing Board and

to request that the licensing board

question the applicant on those matters.

The conduct of an informal hearing is

discussed in more detail in Section C

below. Under certain circumstances, a

party in an informal hearing may

request that the Commission hold a

formal hearing on specific and

substantial factual disputes necessary to

resolution of the matters for which the

party was granted an informal hearing

(see Section C.11 below).

A person may request an informal

hearing even though that person has not

submitted separate written comments

on the design certification rule (i.e., is

not a commenter). Requests for an

informal hearing must be received by

the Commission no later than 120 days

from the publication of this notice, and

a copy of the request must be sent via

overnight mail to the design

certification applicant at the following

address: Mr. Joseph F. Quirk, Mail Code

782, GE Nuclear Energy, 175 Curtner

Avenue, San Jose, CA 95125. The

information which a person requesting

a hearing must provide in the hearing

request, as well as the procedures and

standards to be used by the Commission

in its determination of the request, are

discussed in Sections C.1 through C.4

below.

A person who needs to review

proprietary information submitted by

the design certification applicant in

order to prepare a request for an

informal hearing must follow the

procedures and filing schedule set forth

in Section V.E. below.

The Commission is also providing an

opportunity for interested state, county,

and city/municipal and other local

governments, as well as Native

American tribal governments to

participate as ‘‘interested governments’’

in any informal hearings which the

Commission authorizes, similar to their

participation as ‘‘interested

governments’’ in subpart G hearings

under 10 CFR 2.715. State, county, city/

municipal, local, and tribal governments

wishing to participate as an ‘‘interested

government’’ in any design certification

rulemaking hearings which may be held

must file their request to participate no

later than 120 days from the publication

of this notice.

C. Hearing Process

1. Filings and Computation of Times

All notices, papers, or other filings

discussed in this section must be filed

by express mail.5 The time periods

specified in this section have been

established based upon such a filing.

The express mail filing requirement

shall be considered in establishing other

filing deadlines.

In computing any period of time, the

day of the act, event or default after

which the designated period of time

begins to run is not included. The last

day of the period so computed is

included, unless it is a Saturday,

Sunday, or legal holiday at the place

where the action or event is to occur, in

which case the period runs until the

next day which is neither a Saturday,

Sunday, nor holiday.

2. Content of Hearing Request

The Commission will grant a request

for an informal hearing only if the

hearing request satisfies each of the

following two requirements. First, the

hearing request must include the

written presentations which the

requestor wishes to be included in the

record of the hearing. The written

presentations must:

(i) Identify the specific portion of the

proposed design certification rule or

supporting bases which are challenged,

(ii) Describe the reasons why the

proposed rule or supporting bases are

incorrect or insufficient, and

(iii) Identify the references or sources

upon which the person requesting the

hearing relies.

If the requestor has submitted written

comments in the public comment

period addressing these three factors for

the specific issue for which the

requestor seeks a hearing, it will be

sufficient for the requestor to identify

the portions of the written comments

which the requestor intends to submit

as a written presentation. Also, the

hearing request must demonstrate that

the requestor (or other persons

identified in the hearing request who

will represent, assist, or speak on behalf

of the requestor at the hearing) has

appropriate knowledge and

qualifications to enable the requestor to

contribute significantly to the

development of the hearing record on

the specific matters at issue. The

Commission does not intend that the

requestor meet a judicial ‘‘expert

witness’’ standard in order to meet the

second criterion. Nonetheless, given the

substantial commitment of time and

resources associated with any hearing,

the Commission believes it to be a

reasonable prerequisite that the hearing

requestor demonstrate that he/she (or

his/her assistant) has:

(i) Substantial familiarity with the

publicly available docketed information

relevant to the issue for which a hearing

is requested;

(ii) The requisite technical capability

to understand the factual matters and

develop a record on the issue for which

a hearing is requested; and
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17917

6Requestors will satisfy this requirement by

stating that they possess and have read a copy of

10 CFR part 2, subparts A, G, and L.

(iii) An understanding of the NRC’s

hearing procedures in 10 CFR part 2.6

3. Request to Hold Hearing Outside of

Washington, DC

Any hearing(s) which the Commission

may authorize ordinarily will be

conducted in the Washington, DC

metropolitan area. However, the

Commission at its discretion may

schedule hearings outside the

Washington, DC metropolitan area in

response to requests submitted by a

person requesting a hearing that all or

part of the hearing be held elsewhere.

These requests must be submitted in

conjunction with the request for

hearing, and must specifically explain

the special circumstances for holding a

hearing outside the Washington, DC

metropolitan area.

4. Responses to Hearing Request

The applicant may file a response to

any hearing request within 15 days of

the date of the hearing request. The NRC

staff will not provide a response to the

hearing request unless requested to do

so by the Commission but may assist the

Commission in its ruling on the request.

5. Commission Determination of

Hearing Request

The Commission intends to rule on a

hearing request within 20 days of the

close of the period for requesting a

hearing. The Commission’s

determination will be based upon the

materials accompanying the hearing

request and the applicant’s response

(and the NRC staff’s response, if

requested by the Commission). The

hearing request shall be granted if:

(i) The request is accompanied by a

written presentation containing the

information required by Section C.2.

above; and

(ii) The requestor has the appropriate

knowledge and qualifications to enable

the requestor to contribute significantly

to the development of the hearing

record on the matters sought to be

controverted.

The Commission may consult with

the NRC staff before its determination of

a hearing request. A written decision

either granting or denying the hearing

request will be published by the

Commission.

If a hearing request is granted in

whole or in part, the Commission’s

decision will delineate the controverted

matter that will be the subject of the

hearing and whether any issues and/or

parties are to be consolidated (see

Section C.7. below). The Commission’s

decision granting the hearing will direct

the establishment of a licensing board to

preside over the informal hearing.

Finally, the Commission’s decision will

specify:

(i) The date by which any requests for

discovery must be filed with the

licensing board (normally 20 days after

the date of the Commission’s decision),

and

(ii) The date by which any objections

to discovery must be filed (see Section

C.9. below).

The Commission’s decision will be

sent to each admitted party by overnight

mail. Separate hearings may be granted

for each controverted matter or set of

consolidated matters. Thus, if there are

three different controverted matters, the

Commission may establish three

separate hearings. In this fashion,

closing of the hearing record on a

controverted matter and its referral to

the Commission for resolution need not

await completion of the hearing on the

other controverted matters. Finally, the

Commission’s decision will rule on any

requests for hearings outside of the

Washington, DC metropolitan area (see

Section C.3 above).

6. Authority of the Licensing Board

If the Commission authorizes an

informal hearing on a controverted

matter, the licensing board will function

as a ‘‘limited magistrate’’ in that hearing

with the authority and responsibility for

assuring that a sufficient record is

developed on those controverted

matters which the Commission has

determined are appropriate for

consideration in that hearing. The

licensing board shall have the following

specific responsibilities and authority:

(i) Schedule and expeditiously

conduct the informal hearing for each

admitted controverted matter, consistent

with the rights of all the parties,

(ii) Review all discovery requests

against the criteria established by the

Commission, and refer all appropriate

requests to the Commission with a

decision explaining the licensing

board’s action,

(iii) Preside over and resolve any

issues regarding the scheduling and

conduct of any discovery authorized by

the Commission,

(iv) Order such further consolidation

of parties and issues as the licensing

board determines is necessary or

desirable,

(v) Orally examine persons making

oral presentations in the informal

hearing, based in part upon the

licensing board’s review of the parties’

proposed oral questions to be asked of

persons making oral presentations,

(vi) Request that the NRC staff:

(A) Answer licensing board questions

about the SER or the proposed rule,

(B) Provide additional information or

documentation with respect to the

design certification, and

(C) Provide other assistance as the

licensing board may request. Licensing

board requests for NRC staff assistance

should be framed such that the NRC

staff does not assume a role as an

adversary party in the informal hearing

(see Section C.8 below),

(vii) Review all requests for additional

hearing procedures and refer all

appropriate requests to the Commission

with a decision explaining the licensing

board’s action,

(viii) Certify the hearing record to the

Commission, based upon the licensing

board’s determination that the hearing

record contains sufficient information

for the Commission to make a reasoned

determination on the controverted

matter; and

(ix) Include with its certification any

concerns identified by the licensing

board in the course of the hearing

which, although neither raised by the

parties nor necessary to resolution of the

controverted hearing matters, are

significant enough in the licensing

board’s view to warrant attention by the

Commission.

Licensing board determinations with

respect to referral of requests to the

Commission, as well as licensing board

determinations of parties’ motions, are

not appealable to the Commission as an

interlocutory matter. Instead, any

disagreements with the licensing

board’s determinations, and a specific

discussion of how the hearing record is

deficient with respect to the contested

issue must be set forth in the parties’

proposed findings of fact which are

submitted directly to the Commission

(see Section C.13 below).

As suggested by Item (10) above, the

licensing board shall not have any ‘‘sua

sponte’’ authority analogous to 10 CFR

2.760a. The Commission believes that in

the absence of a request for an informal

hearing on a matter, the Commission

should resolve issues with respect to the

design certification rule in the same

manner as other agency-identified

rulemaking issues, viz., through NRC

staff consideration of the issue followed

by the Commission’s review and its

final resolution of the matter. However,

when it certifies the completed hearing

record to the Commission (see Section

C.12. below), the licensing board should

identify to the Commission any

concerns identified during the hearing

that are significant enough to warrant

Commission consideration but that are

unnecessary or irrelevant to the
17918 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

resolution of the controverted hearing

matter.

The licensing board shall close the

hearing and certify the record to the

Commission only after it determines

that the record on the controverted

matter is sufficiently complete for the

Commission to make a reasoned

determination with respect to that

matter. However, the licensing board

shall not have any responsibility or

authority to resolve and decide

controverted matters in either an

informal or a formal hearing. Rather, the

Commission retains its traditional

authority in rulemaking proceedings to

evaluate and resolve all rulemaking

issues identified in public comments on

a proposed rule. Therefore, the

Commission will resolve any

controverted matters that are the subject

of a hearing in this design certification

rulemaking.

7. Consolidation of Parties and Issues;

Joint Hearings on Related Issues

If two or more persons seek an

informal hearing on the same or similar

matters, the Commission may, in its

discretion, grant an informal hearing

and consolidate the matters into a single

issue (as defined by the Commission).

The Commission may also, in its

discretion, require that the parties be

consolidated analogous to the

consolidation permitted under 10 CFR

2.715a. If the Commission consolidates

two or more issues into a single

consolidated issue but does not

consolidate parties, each admitted

person will be deemed a separate party

with an individual right to:

(i) Submit separate written

presentations,

(ii) Submit separate sets of proposed

oral questions to be asked by the

licensing board (see Section C.10

below),

(iii) Make separate oral presentation,

and

(iv) Submit and separately respond to

motions.

If the Commission also requires that

parties be consolidated, the

consolidated parties must participate

jointly, including deciding upon written

and oral presentations, submitting a

single set of written questions,

submitting motions supported by each

of the consolidated parties, and

responding to motions filed by other

parties.

During the informal hearing, the

licensing board may decide that further

consolidation of issues or parties would

simplify the overall conduct of informal

hearings or materially reduce the time

or resources devoted to the hearings. In

these instances, the licensing board may

direct such consolidation. The licensing

board shall set forth the issues and/or

parties to be consolidated and the

reasons for such consolidation in a

written order.

8. Status of the Design Certification

Applicant, the NRC staff, and

Requesting Party

The design certification applicant

shall be a party in the informal hearing,

with the right to submit written and oral

presentations, propose questions to be

asked by the licensing board of oral

presenters, and file and submit

appropriate motions.

The NRC staff shall not be a party in

the informal hearing but shall be

available in the informal hearing to

answer licensing board questions about

the FSER or the proposed rule, provide

additional information or

documentation with respect to the

design certification, and provide other

assistance that the licensing board may

request without the NRC staff assuming

the role of a party in the informal

hearing.

A party whose hearing requests have

been granted with respect to a particular

controverted matter shall not participate

with respect to any controverted matter

on which the party was not granted a

hearing. For example, if Person 1 has

been authorized as a party on Issue A

and Person 2 has been authorized as a

party on Issue B, then Person 1 may

participate only in the informal hearing

on Issue A, and may not participate in

the informal hearing on Issue B.

Conversely, Person 2 may participate

only in the informal hearing on Issue B,

and may not participate in the informal

hearing on Issue A.

9. Requests for Discovery

Any party may request the

opportunity to conduct discovery

against another party before the oral

phase of the informal hearing. The

request for discovery must:

(i) Identify the type of discovery

permitted under 10 CFR 2.740, 2.740a,

2.740a(b), 2.741, and 2.742 which the

party seeks to use;

(ii) Identify the subject matter or

nature of the information sought to be

obtained by discovery; and

(iii) Explain with particularity the

relevance of the information sought to

the controverted matter which is the

subject of the hearing and why this

information is indispensable to the

presentation of the party’s position on

the controverted matter.

The request shall be filed with the

licensing board, with copies of the

request to be filed with the party against

which discovery is sought, and the NRC

staff. The requests must be received no

later than the deadline specified by the

Commission in its decision granting a

party’s hearing request (see Section C.5.

above). A party against whom discovery

is sought may file a response objecting

to part or all of the request. Such a

response must explain with particularity

why the discovery request should not be

granted.

The licensing board shall review all

discovery requests and refer to the

Commission those requests that it

believes should be granted within 7

days after the date for receiving a party’s

objections to a discovery request. The

licensing board shall issue a written

decision explaining its basis for either

referring the request to the Commission

or declining to refer it. The written

decision shall accompany the discovery

requests which are referred by the

licensing board to the Commission.

The Commission will determine

whether to grant any discovery requests

forwarded to it based upon the licensing

board’s decision, together with the

request and the design certification

applicant’s response (and any NRC staff

response requested by the licensing

board). Discovery will be at the

discretion of the Commission. In this

regard, the Commission notes that two

docket files have been established by

the NRC staff for the U.S. ABWR design

certification review. The first docket file

(STN 50–605) was established on

February 22, 1988, and the second

docket file (52–001) became effective on

March 13, 1992. The NRC staff has

placed information and documents

received from the design certification

applicant in these docket files. This

information includes the Design Control

Document, Revision 2, and the

Technical Support Document for the

U.S. ABWR, Revision 1. Furthermore,

the docket files contain NRC staff

communications and documents, such

as written questions and comments

provided to the design certification

applicant, and summaries of meetings

held between the NRC staff and the

design certification applicant. The NRC

Staff’s bases for approving the U.S.

ABWR design are set forth in the FSER

(NUREG–1503), dated July 1994. The

Commission also notes that each

admitted party has already disclosed a

substantial amount of information in its

hearing request, relating both to bases

for the party’s position with respect to

the controverted matter as well as

information on the qualifications of the

party (or its representatives and

witnesses in the hearing).

As discussed above, much of the

information documenting the NRC

staff’s review and approval of the design
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17919

certification application has been

routinely placed in the docket file.

Furthermore, as discussed in Section

C.8., the NRC staff is not a party in an

informal hearing. Therefore, the

Commission has decided that in an

informal hearing, the parties should not

be afforded discovery against the NRC

staff.

10. Conduct of Informal Hearing

If the Commission authorizes

discovery, the licensing board shall

establish a schedule for the conduct and

completion of discovery. Normally, the

licensing board should not permit more

than one round of discovery. The

Commission will not entertain any

interlocutory appeals from licensing

board orders resolving any discovery

disputes or otherwise complaining of

the scheduling of discovery.

Following the completion of

discovery, the licensing board should

issue an order setting forth the date of

commencement of the oral phase of

each informal hearing, and the date (no

less than thirty (30) days before the

commencement of the oral phase of the

hearing) by which parties must submit:

(i) The identities and curriculum vitae

of those persons providing oral

presentations;

(ii) The outlines of the oral

presentations; and

(iii) Any questions which a party

would like the licensing board to ask.

The licensing board may schedule the

oral phases of two or more informal

hearings to be held during the same

session.

The licensing board shall publish a

notice in the Federal Register

announcing the commencement of the

oral phase of the informal hearing(s).

The notice shall set forth the place and

time of the oral hearing session, the

subject matter(s) of the informal

hearing(s), a brief description of the

informal hearing procedures, and a

statement indicating that the public may

observe the informal hearing.

Based upon the parties’ outlines of the

oral presentation and proposed

questions, the licensing board should

determine whether it has specific

questions of the NRC staff with respect

to the staff’s review of the design

certification application. These

questions should be submitted in

writing to the NRC no less than 20 days

before the commencement of the oral

phase of the hearing and must specify

the date by which the NRC staff shall

provide its written answers to the

licensing board. The licensing board

shall send copies of the request by

overnight mail to all parties. The NRC

staff shall file its written answers with

the licensing board and the parties.

During the oral phase of the hearing,

the licensing board shall receive into

evidence the written presentations of

the parties and permit each party (or the

representatives identified in their

hearing request) to make oral

presentations addressing the

controverted matter. Normally, the party

raising the controverted matter should

make their presentations, followed by

the presentations of the design

certification applicant. The licensing

board may question the persons making

oral presentations, using its own

questions as well as those submitted to

the licensing board by the other parties.

Based upon the parties’ oral

presentations and/or responses to

licensing board questions, the licensing

board may also orally question the NRC

staff.

11. Additional Hearing Procedures and

Formal Hearings

After the parties have made their oral

presentations and the licensing board

has concluded its questioning of the

presenters (and, as applicable, the NRC

staff), the licensing board should declare

that the oral phase of an informal

hearing on a controverted matter (or

consolidated set of controverted

matters) is complete.

No later than 10 days after the

licensing board has declared that the

oral phase of the informal hearing has

been completed, parties may file with

the licensing board (with copies to the

applicant and the NRC staff) a request

that some or all of the procedures

described in 10 CFR part 2, subpart G

(e.g., direct and cross-examination by

the parties) be utilized. The request

shall:

(i) Identify the specific hearing

procedures which the party seeks, or

state that a formal hearing is requested;

(ii) Identify the specific factual issues

for which the additional procedures

would be utilized,

(iii) Explain why resolution of these

factual disputes are necessary to the

Commission’s decision on the

controverted issue;

(iv) Explain, with specific citations to

the hearing record, why the record is

insufficient on the controverted matter,

and

(v) Identify the nature of the evidence

that would be developed utilizing the

additional procedures requested.

The design certification applicant

may file a response to these requests no

later than seven days after the

applicant’s receipt of a request for

additional procedures. The NRC staff

will not provide a response unless

specifically requested to do so by the

licensing board.

The licensing board will review all

requests for additional hearing

procedures or a formal hearing and refer

those that it believes should be granted

to the Commission for its determination.

The licensing board shall issue a written

decision explaining its determination

whether to forward the request to the

Commission no later than 7 days after

receipt of any applicant response to the

request. The decision will provide the

basis for either forwarding the request to

the Commission or declining to forward

it. In the absence of any requests for

hearing procedures or if the licensing

board concludes that none of the

requests should be referred to the

Commission, the licensing board should

declare that the hearing record is closed

(see Section C.12 below).

The Commission will determine

whether to grant any requests for

additional procedures or a formal

hearing that are forwarded by the

licensing board. The Commission’s

determination shall be based upon the

licensing board’s decision along with

the request and the design certification

applicant’s response. If the Commission

directs that a formal hearing be held on

a controverted factual matter, the NRC

staff shall be a party in the formal

hearing. After either the additional

hearing procedures authorized by the

Commission are completed or the

formal hearing is concluded on the

factual dispute, the licensing board

should declare the hearing record closed

(see Section C.12 below).

12. Licensing Board’s Certification of

Hearing Record to the Commission

After the oral phase of a hearing is

completed and either:

(i) There are no requests for additional

hearing procedures or a formal hearing,

or

(ii) The licensing board concludes

that none of the requests should be

referred to the Commission, then the

licensing board should declare that the

hearing record is closed.

If the Commission directs that

additional hearing procedures should be

utilized or a formal hearing be held on

specific factual disputes, the licensing

board should declare the hearing record

closed after completion of the additional

hearing procedures or the formal

hearing. Within 30 days of the closing

of the hearing record the licensing board

should certify the hearing record to the

Commission on each controverted
17920 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

7An informal hearing is deemed to be completed

when the period for requesting additional

procedures or a formal hearing expires and no

request is received.

matter (or consolidated set of

controverted matters).7

The licensing board’s certification for

each controverted matter (or

consolidated set of controverted

matters) shall contain:

(i) The hearing record, including a

transcript of the oral phase of the

hearing (and any pre-hearing

conferences) and copies of all filings by

the parties and the licensing board,

(ii) A list of all documentary evidence

admitted by the licensing board,

including the written presentations of

the parties,

(iii) Copies of the documentary

evidence admitted by the licensing

board,

(iv) A list of all witnesses who

provided oral testimony,

(v) The NRC staff’s written answers to

licensing board requests, and

(vi) A licensing board statement that

the hearing record contains sufficient

information for the Commission to make

a reasoned determination on the

controverted matter.

Finally, as discussed in Section C.6

above, the licensing board should

identify any issues not raised by the

parties or otherwise are not relevant to

the controverted matters in the hearing,

that the licensing board nonetheless

believes are significant enough to

warrant attention by the Commission.

13. Parties’ Proposed Findings of Fact

and Conclusions

The applicant must file directly with

the Commission proposed findings of

fact and conclusions for each

controverted hearing matter (or

consolidated set of controverted

matters) within 30 days following the

close of the hearing record on that

matter in the form of a proposed final

rule and statement of considerations

with respect to the controverted hearing

issues.

Other parties are encouraged, but not

required, to file with the Commission

proposed findings of fact and

conclusions limited to those issues

which a party was afforded a hearing by

the Commission (i.e., a party may not

file proposed findings of fact and

conclusions on issues which it was not

admitted). Any findings that a party

wishes the Commission to consider

must be received by the Commission no

later than 30 days after the licensing

board closes the hearing record on that

issue. Although parties are not required

to file proposed findings and

conclusions, a party who does not file

a finding may not, upon appeal, claim

or otherwise argue that the Commission

either misunderstood the party’s

position, or failed to address a specific

piece of evidence or issue.

D. Resolution of Issues for the Final

Rulemaking

1. Absence of Qualifying Hearing

Request

If the Commission does not receive

any request for hearing within the 120-

day period for submitting a request, or

does not grant any of the requests (see

Section V.B. above), the Commission

will determine whether the proposed

design certification rule meets the

applicable standards and requirements

of the Atomic Energy Act of 1954; as

amended (AEA), the National

Environmental Policy Act of 1969; as

amended (NEPA), and the Commission’s

rules and regulations. The

Commission’s determination will be

based upon the rulemaking record,

which includes: The application for

design certification, including the SSAR

and DCD; the applicant’s responses to

the NRC staff’s requests for additional

information; the NRC staff’s FSER and

any supplements thereto; the report on

the application by the ACRS; the

applicant’s Technical Support

Document addressing consideration of

severe accident mitigation design

alternatives (SAMDAs) for purposes of

NEPA; the NRC staff’s EA and draft

FONSI; the proposed rule, and the

public comments received on the

proposed rule. If the Commission makes

an affirmative finding, it will issue a

standard design certification in the form

of a rule by adding a new appendix to

10 CFR part 52, and publish the design

certification rule and a statement of

considerations in the Federal Register.

2. Commission Resolution of Issues

Where a Hearing is Granted

All matters related to the proposed

design certification rule, including those

matters for which the Commission

authorizes a hearing (see Sections B.

and C. above), will be resolved by the

Commission after the licensing board

has closed the hearing record and

certified it to the Commission. The

Commission will determine whether the

proposed design certification rule meets

the applicable standards and

requirements of the AEA, NEPA, and

the Commission’s rules and regulations.

The Commission’s determination will

be based upon the rulemaking record as

described in Section D.1 above, with the

addition of the hearing record for

controverted matters. If the Commission

makes an affirmative finding, the

Commission will issue a final design

certification rule as described in Section

D.1.

E. Access to Proprietary Information in

Rulemaking

1. Access to Proprietary Information for

the Preparation of Written Comments or

Informal Hearing Requests

Persons who determine that they need

to review proprietary information

submitted by the design certification

applicant to the NRC in order to submit

written comments on the proposed

certification or to prepare an informal

hearing request, may request access to

such information from the applicant.

The request shall state with

particularity:

(i) The nature of the proprietary

information sought,

(ii) The reason why the

nonproprietary information currently

available to the public in the NRC’s

Public Document Room is insufficient

either to develop public comments or to

prepare for the hearing,

(iii) The relevance of the requested

information either to the issue which

the commenter wishes to comment on,

and

(iv) A showing that the person

requesting the information has the

capability to understand and utilize the

requested information.

Requests must be filed with the

applicant such that they are received by

the applicant no later than 45 days after

the date that this notice of proposed

rulemaking is published in the Federal

Register.

Within ten (10) days of receiving the

request, the applicant must send a

written response to the person seeking

access. The response must either

provide the documents requested (or

state that the document will be provided

no later than ten days after the date of

the response), or state that access has

been denied. If access is denied, the

response shall state with particularity

the reasons for its refusal. The

applicant’s response must be provided

via express mail.

The person seeking access may then

request a Commission hearing for the

purpose of obtaining a Commission

order directing the design certification

applicant to disclose the requested

information. The person must include

copies of the original request (and any

subsequent clarifying information

provided by the person requesting

access to the applicant) and the

applicant’s response. The Commission

will base its decision solely on the

person’s original request (including any
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17921

clarifying information provided to the

applicant by the person requesting

access), and the applicant’s response.

Accordingly, a person seeking access to

proprietary information should ensure

that the request sets forth in sufficient

detail and particularity the information

required to be included in the request.

Similarly, the applicant should ensure

that its response to any request states

with sufficient detail and particularity

the reasons for its refusal to provide the

requested information.

If the Commission orders access in

whole or part, the Commission will

specify the date by which the requesting

party must file with the Commission

written comments and any request for

an informal hearing before a licensing

board as discussed in Section V.C.,

above. A request for an informal hearing

must meet the requirements set forth

above in Section V.C., in particular the

requirements governing the content of

the hearing request, and shall be

governed by the procedures and

standards governing such requests set

forth in Section V.C.

2. Access to Proprietary Information in

a Hearing

Parties who are granted a hearing may

request access to proprietary

information. Parties must first request

access to proprietary information

regarding the proposed design

certification from the applicant. The

request shall state with particularity:

(i) The nature of the proprietary

information sought,

(ii) The reason why the

nonproprietary information currently

available to the public in the NRC’s

Public Document Room is insufficient to

prepare for the hearing,

(iii) The relevance of the requested

information to the hearing issue(s) for

which the party has been admitted, and

(iv) A showing that the requesting

party has the capability to understand

and utilize the requested information.

The request must be filed with the

applicant no later than the date

established by the Commission for filing

discovery requests with the licensing

board.

If the applicant declines to provide

the information sought, within ten (10)

days of receiving the request the

applicant must send a written response

to the requesting party setting forth with

particularity the reasons for its refusal.

The party may then request the

licensing board to order disclosure. The

party must include copies of the original

request (and any subsequent clarifying

information provided by the requesting

party to the applicant) and the

applicant’s response. The licensing

board shall base its decision solely on

the party’s original request (including

any clarifying information provided by

the requesting party to the applicant),

and the applicant’s response.

Accordingly, a party requesting

proprietary information from the

applicant should ensure that its request

sets forth in sufficient detail and

particularity the information required to

be included in the request. Similarly,

the applicant should ensure that its

response to any request states with

sufficient detail and particularity the

reasons for its refusal to provide the

requested information. The licensing

board may order the applicant to

provide access to some or all of the

requested information, subject to an

appropriate non-disclosure agreement.

F. Ex Parte and Separation of Functions

Restrictions

Unless the formal procedures of 10

CFR Part 2, Subpart G are approved for

a formal hearing in the design

certification rulemaking proceeding, the

NRC staff will not be a party in the

hearing and separation of functions

limitations will not apply. The NRC

staff may assist in the hearing by

answering questions about the FSER put

to it by the licensing board, or to

provide additional information,

documentation, or other assistance as

the licensing board may request.

Furthermore, other than in a formal

hearing, the NRC staff shall not be

subject to discovery by any party,

whether by way of interrogatory,

deposition, or request for production of

documents.

Second, the Commission has

determined that once a request for an

informal or formal hearing is received,

certain elements of the ex parte

restrictions in 10 CFR 2.780(a) will be

applicable with respect to the subject

matter of that hearing request. Under

these restrictions, the Commission will

communicate with interested persons/

parties, the NRC staff, and the licensing

board with respect to the issues covered

by the hearing request only through

docketed, publicly-available written

communications and public meetings.

Individual Commissioners may

communicate privately with interested

persons and the NRC staff; however, the

substance of the communication shall

be memorialized in a document which

will be placed in the PDR and

distributed to the licensing board and

relevant parties.

VI. Finding of No Significant

Environmental Impact: Availability

The Commission has determined

under the NEPA and the Commission’s

regulations in 10 CFR part 51, subpart

A, that this proposed design

certification rule, if adopted, would not

be a major Federal action significantly

affecting the quality of the human

environment, and therefore an

environmental impact statement (EIS) is

not required. The basis for this

determination, as documented in the

environmental assessment, is that the

amendment to 10 CFR part 52 would

not authorize the siting, construction, or

operation of a facility using the U.S.

ABWR design; it would only codify the

U.S. ABWR design in a rule. The NRC

will evaluate the environmental impacts

and issue an EIS as appropriate in

accordance with NEPA as part of the

application(s) for the construction and

operation of a facility.

In addition, as part of the

environmental assessment for the

ABWR design, the NRC reviewed

pursuant to NEPA, GE’s evaluation of

various design alternatives to prevent

and mitigate severe accidents that was

submitted in GE’s ‘‘Technical Support

Document for the ABWR’’. The

Commission finds that GE’s evaluation

provides a sufficient basis to conclude

that there is reasonable assurance that

an amendment to 10 CFR part 52

certifying the U.S. ABWR design will

not exclude a severe accident design

alternative for a facility referencing the

certified design that would have been

cost beneficial had it been considered as

part of the original design certification

application. These issues are considered

resolved for the U.S. ABWR design.

The environmental assessment, upon

which the Commission’s finding of no

significant impact is based, and the

Technical Support Document for the

ABWR are available for examination

and copying at the NRC Public

Document Room, 2120 L Street, NW.

(Lower Level), Washington, DC. Single

copies are also available from Mr. Harry

Tovmassian, Mailstop T–9 F33, Office of

Nuclear Regulatory Research, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555, (301) 415–6231.

VII. Paperwork Reduction Act

Statement

This proposed rule amends

information collection requirements that

are subject to the Paperwork Reduction

Act of 1980 (44 U.S.C. 3501 et seq.).

This rule has been submitted to the

Office of Management and Budget for

review and approval of the paperwork

requirements. The public reporting

burden for this collection of information

is zero hours. Send comments regarding

this burden estimate or any other aspect

of this collection of information,

including suggestions for reducing this
17922 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

burden, to the Information and Records

Management Branch (T 6–F33), U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001; and to the

Desk Officer, Office of Information and

Regulatory Affairs, NEOB–10202,

(3150–0151), Office of Management and

Budget, Washington, DC 20503.

VIII. Regulatory Analysis

The NRC has not prepared a

regulatory analysis for this proposed

rule. The NRC prepares regulatory

analyses for rulemakings that establish

generic regulatory requirements. Design

certifications are not generic

rulemakings. Rather, design

certifications are Commission approvals

of specific nuclear power plant designs

by rulemaking. Furthermore, design

certification rulemakings are initiated

by an applicant for a design

certification, rather than the NRC.

Preparation of a regulatory analysis in

this circumstance would not be useful

because the design to be certified is

proposed by the applicant rather than

the NRC. For these reasons, the

Commission concludes that preparation

of a regulatory analysis is neither

required nor appropriate.

IX. Regulatory Flexibility Act

Certification

In accordance with the Regulatory

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

the Commission certifies that this

proposed rulemaking will not have a

significant economic impact upon a

substantial number of small entities.

The proposed rule provides standard

design certification for a light water

nuclear power plant design. Neither the

design certification applicant, nor

nuclear power plant licensees who

reference this design certification rule,

fall within the scope of the definition of

‘‘small entities’’ set forth in the

Regulatory Flexibility Act, 15 U.S.C.

632, or the Small Business Size

Standards set out in regulations issued

by the Small Business Administration in

13 CFR part 121. Thus, this rule does

not fall within the purview of the act.

X. Backfit Analysis

The Commission has determined that

the backfit rule, 10 CFR 50.109, does not

apply to this proposed rule because

these amendments do not impose

requirements on existing 10 CFR part 50

licensees. Therefore, a backfit analysis

was not prepared for this rule.

List of Subjects in 10 CFR Part 52

Administrative practice and

procedure, Antitrust, Backfitting,

Combined license, Early site permit,

Emergency planning, Fees,

Incorporation by reference, Inspection,

Limited work authorization, Nuclear

power plants and reactors, Probabilistic

risk assessment, Prototype, Reactor

siting criteria, Redress of site, Reporting

and recordkeeping requirements,

Standard design, Standard design

certification.

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; and 5 U.S.C. 553; the NRC

proposes to adopt the following

amendment to 10 CFR part 52.

PART 52—[AMENDED]

1. The authority citation for 10 CFR

Part 52 continues to read as follows:

Authority: Secs. 103, 104, 161, 182, 183,

186, 189, 68 Stat. 936, 948, 953, 954, 955,

956, as amended, sec. 234, 83 Stat. 1244, as

amended (42 U.S.C. 2133, 2201, 2232, 2233,

2236, 2239, 2282); secs. 201, 202, 206, 88

Stat. 1243, 1244, 1246, 1246, as amended (42

U.S.C. 5841, 5842, 5846).

2. In § 52.8, paragraph (b) is revised to

read as follows:

§ 52.8 Information collection

requirements: OMB approval.

* * * * *

(b) The approved information

collection requirements contained in

this part appear in §§ 52.15, 52.17,

52.29, 52.45, 52.47, 52.57, 52.75, 52.77,

52.78, 52.79, and appendix A.

3. A new appendix A to 10 CFR part

52 is added to read as follows:

Appendix A To Part 52—Design Certification

Rule for the U.S. Advanced Boiling Water

Reactor

1. Scope.

This appendix constitutes the standard

design certification for the U.S. Advanced

Boiling Water Reactor (ABWR) design, in

accordance with 10 CFR part 52, subpart B.

The applicant for certification of the U.S.

ABWR design was GE Nuclear Energy.

2. Definitions.

As used in this part:

(a) Design control document (DCD) means

the master document that contains the Tier

1 and Tier 2 information that is incorporated

by reference into this design certification

rule.

(b) Tier 1 means the portion of the designrelated information contained in the DCD

that is certified by this design certification

rule (hereinafter Tier 1 information). Tier 1

information consists of:

(1) Definitions and general provisions;

(2) Certified design descriptions;

(3) Inspections, tests, analyses, and

acceptance criteria (ITAAC);

(4) Significant site parameters; and

(5) Significant interface requirements.

The certified design descriptions, interface

requirements, and site parameters are derived

from Tier 2 information.

(c) Tier 2 means the portion of the designrelated information contained in the DCD

that is approved by this design certification

rule (hereinafter Tier 2 information). Tier 2

information includes:

(1) The information required by 10 CFR

52.47;

(2) The information required for a final

safety analysis report under 10 CFR 50.34(b),

and

(3) Supporting information on the

inspections, tests, and analyses that will be

performed to demonstrate that the acceptance

criteria in the ITAAC have been met.

(d) Tier 2* means the portion of the Tier

2 information which cannot be changed

without prior NRC approval. This

information is identified in the DCD.

(e) All other terms in this rule have the

meaning set out in 10 CFR 50.2, 10 CFR 52.3,

or Section 11 of the Atomic Energy Act of

1954, as amended, as applicable.

3. [Reserved].

4. Contents of the design certification.

(a) Both Tier 1 and Tier 2 of the ABWR

Design Control Document, GE Nuclear

Energy, Revision 2, January 1995 are

incorporated by reference. This incorporation

by reference was approved by the Director of

the Office of the Federal Register on [Insert

date of approval] in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies of the U.S.

ABWR DCD may be obtained from [Insert

name and address of applicant or

organization designated by the applicant].

Copies are also available for examination and

copying at the NRC Public Document Room,

2120 L Street NW. (Lower Level),

Washington, DC 20555, and for examination

at the NRC Library, 11545 Rockville Pike,

Rockville, Maryland 20582–2738.

(b) An applicant for a construction permit,

operating license, or combined license that

references this design certification shall

reference both Tier 1 and Tier 2 of the U.S.

ABWR DCD.

(c) If there is a conflict between the U.S.

ABWR DCD and either the application for

design certification for the U.S. ABWR design

or NUREG–1503, ‘‘Final Safety Evaluation

Report related to the Certification of the

Advanced Boiling Water Reactor Design,’’

dated July 1994 (FSER), then the U.S. ABWR

DCD is the controlling document.

5. Exemptions and applicable regulations.

(a) The U.S. ABWR design is exempt from

portions of the following regulations, as

described in the FSER (index provided in

Section 1.6 of the FSER):

(1) Section VI(a)(2) of appendix A to 10

CFR part 100—Operating Basis Earthquake

Design Consideration;

(2) Section (b)(3) of 10 CFR 50.49—

Environmental Qualification of PostAccident Monitoring Equipment;

(3) Section (f)(2)(iv) of 10 CFR 50.34—

Separate Plant Safety Parameter Display

Console;

(4) Section (f)(2)(viii) of 10 CFR 50.34—

Post-Accident Sampling for Boron, Chloride,

and Dissolved Gases; and

(5) Section (f)(3)(iv) of 10 CFR 50.34—

Dedicated Containment Penetration.

(b) Except as indicated in paragraph (c) of

this section, the regulations that apply to the

U.S. ABWR design are those regulations in 10
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17923

1For the standard design, the footnote reference

in 10 CFR 50.48(a) to Branch Technical Position

Auxiliary Power Conversion System Branch BTP

APCSB9.5–1, ‘‘Guidelines for Fire Protection for

Nuclear Power Plants,’’ will be to the July 1981

version.

CFR Parts 20, 50, 73, and 100 (July 1994),

that are applicable and technically relevant,

as described in the FSER.

(c) In addition to the regulations specified

in paragraph (b) of this section, the following

regulations are applicable for purposes of 10

CFR 52.48, 52.54, 52.59 and 52.63:

(1) In the standard design, the effects of

intersystem loss-of-coolant accidents must be

minimized by designing low-pressure piping

systems that interface with the reactor

coolant pressure boundary to withstand full

reactor coolant system pressure to the extent

practical.

(2)(i) Piping systems associated with

pumps and valves subject to the test

requirements set forth in 10 CFR 50.55a(f)

must be designed to allow for:

(A) Full flow testing of pumps and check

valves at maximum design flow, and

(B) Testing of motor operated valves under

maximum achievable differential pressure,

up to design basis differential pressure, to

demonstrate the capability of the valves to

operate under design basis conditions.

(ii) For pumps and valves subject to the

test requirements set forth in 10 CFR

50.55a(f), an applicant for a combined license

which references this standard design

certification rule shall submit as part of the

application:

(A) A program for testing check valves that

incorporates the use of advanced nonintrusive techniques to detect degradation

and monitor performance characteristics, and

(B) A program to determine the frequency

necessary for disassembly and inspection of

each pump and valve to detect degradation

that would prevent the component from

performing its safety function and which

cannot be detected through the use of

advanced non-intrusive techniques. The

licensee shall implement these programs

throughout the service life of the plant.

(3) For digital instrumentation and control

systems, the design must include:

(i) An assessment of the defense-in-depth

and diversity of instrumentation and control

systems;

(ii) A demonstration of adequate defense

against common-mode failures; and

(iii) Provisions for independent backup

manual controls and displays for critical

safety functions in the control room.

(4) The electric power system of the

standard design must include an alternate

power source that has sufficient capacity and

capability to power the necessary

complement of non-safety equipment that

would most facilitate the ability of the

operator to bring the plant to safe shutdown,

following a loss of the normal power supply

and reactor trip.

(5) The electric power system of the

standard design must include at least one

offsite circuit supplied directly from one of

the offsite power sources to each redundant

safety division with no intervening nonsafety buses in such a manner that the offsite

source can power the safety buses upon a

failure of any non-safety bus.

(6)(i) The requirements of 10 CFR 50.48(a) 1

and 10 CFR part 50, Appendix R, Section III

G.1.a, apply to all structures, systems, and

components important to safety.

(ii) Notwithstanding any provision in

paragraph (i) of this section, all structures,

systems, and components important to safety

in the standard design must be designed to

ensure that:

(A) Safe shutdown can be achieved

assuming that all equipment in any one fire

area will be rendered inoperable by fire and

re-entry into that fire area for repairs and

operator actions is not possible, except that

this provision does not apply to (1) the main

control room, provided that an alternative

shutdown capability exists and is physically

and electrically independent of the main

control room, and (2) the reactor

containment;

(B) Smoke, hot gases, or fire suppressant

will not migrate from one fire area into

another to an extent that could adversely

affect safe-shutdown capabilities, including

operator actions; and

(C) In the reactor containment, redundant

shutdown systems are provided with fire

protection capabilities and means to limit fire

damage such that, to the extent practicable,

one shutdown division remains free of fire

damage.

(7) The standard design must include and

an applicant for a combined license which

references this standard design certification

rule shall submit as part of the application:

(i) The description of the reliability

assurance program used during the design

that includes scope, purpose, and objectives;

(ii) The process used to evaluate and

prioritize the structures, systems, and

components in the design, based on their

degree of risk-significance;

(iii) A list of structures, systems, and

components designated as risk-significant;

and

(iv) For those structures, systems, and

components designated as risk-significant:

(A) A process to determine dominant

failure modes that considered industry

experience, analytical models, and applicable

requirements; and

(B) Key assumptions and risk insights from

probabilistic, deterministic, and other

methods that considered operation,

maintenance, and monitoring activities.

(8) The probabilistic risk assessment

required by 10 CFR 52.47(a)(1)(v) must

include an assessment of internal and

external events. For external events,

simplified probabilistic methods and margins

methods may be used to assess the capacity

of the standard design to withstand the

effects of events such as fires and

earthquakes. Traditional probabilistic

techniques should be used to evaluate

internal floods. For earthquakes, a seismic

margin analysis must consider the effects of

earthquakes with accelerations

approximately one and two-thirds the

acceleration of the safe-shutdown

earthquake.

(9) The standard design must include an

on-site alternate ac power source of diverse

design capable of powering at least one

complete set of equipment necessary to

achieve and maintain safe-shutdown for the

purposes of dealing with station blackout.

(10)(i) The standard design must include

the features in paragraphs (A)–(C) below that

reduce the potential for and effect of

interactions of molten core debris with

containment structures:

(A) Reactor cavity floor space to enhance

debris spreading;

(B) A means to flood the reactor cavity to

assist in the cooling process; and

(C) Concrete to protect portions of the

lower drywell containment liner and other

structural members.

(ii) The features required by paragraphs (i)

of this section, in combination with other

features, must ensure for the most significant

severe accident sequences that the bestestimate environmental conditions (pressure

and temperature) resulting from coreconcrete interaction do not exceed ASME

Code Service Level C for steel containments

or Factored Load Category for concrete

containments for approximately 24 hours.

(11) The standard design must include: (i)

A reliable means to depressurize the reactor

coolant system and (ii) cavity design features

to reduce the amount of ejected core debris

that may reach the upper containment.

(12) The standard design must include

analyses based on best-available methods to

demonstrate that:

(i) Equipment, both electrical and

mechanical, needed to prevent and mitigate

the consequences of severe accidents is

capable of performing its function for the

time period needed in the best-estimate

environmental conditions of the severe

accident (e.g., pressure, temperature,

radiation) in which the equipment is relied

upon to function; and

(ii) Instrumentation needed to monitor

plant conditions during a severe accident is

capable of performing its function for the

time period needed in the best-estimate

environmental conditions of the severe

accident (e.g., pressure, temperature,

radiation) in which the instrumentation is

relied upon to function.

(13) The standard design must include

features to limit the conditional containment

failure probability for the more likely severe

accident challenges.

(14)(i) The standard design must include a

systematic examination of features in relation

to shutdown risk assessing:

(A) Specific design features that minimize

shutdown risk;

(B) The reliability of decay heat removal

systems;

(C) Vulnerabilities introduced by new

design features; and

(D) Fires and floods occurring with the

plant in modes other than full power.

(ii) An applicant for a combined license

which references this design certification

rule shall submit as part of the application

a description of the program for outage

planning and control that ensures:

(A) The availability and functional

capability during shutdown and low power

operations of features important to safety

during such operations; and

(B) The consideration of fire, flood, and

other hazards during shutdown and low
17924 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

power operations. The licensee shall

implement this program throughout the

service life of the plant.

6. Issue resolution for the design

certification.

(a) All nuclear safety issues associated with

the information in the FSER or DCD are

resolved within the meaning of 10 CFR

52.63(a)(4).

(b) All environmental issues associated

with the information in the NRC’s

environmental assessment for the ABWR

design or the severe accident design

alternatives in Revision 1 of the Technical

Support Document for the ABWR, dated

December 1994, are resolved within the

meaning of 10 CFR 52.63(a)(4).

7. Duration of the design certification.

This design certification may be referenced

for a period of 15 years from May 8, 1995,

except as provided for in 10 CFR 52.55(b)

and 52.57(b). This design certification

remains valid for an applicant or licensee

that references this certification until their

application is withdrawn or their license

expires, including any period of extended

operation under a renewed license.

8. Change process.

(a) Tier 1 information.

(1) Generic (rulemaking) changes to Tier 1

information are governed by the

requirements in 10 CFR 52.63(a)(1).

(2) Generic changes to Tier 1 information

are applicable to all plants referencing the

design certification as set forth in 10 CFR

52.63(a)(2).

(3) Changes from Tier 1 information that

are imposed by the Commission through

plant-specific orders are governed by the

requirements in 10 CFR 52.63(a)(3).

(4) Exemptions from Tier 1 information are

governed by the requirements in 10 CFR

52.63(b)(1).

(b) Tier 2 information.

(1) Generic changes to Tier 2 information

are governed by the requirements in 10 CFR

52.63(a)(1).

(2) Generic changes to Tier 2 information

are applicable to all plants referencing the

design certification as set forth in 10 CFR

52.63(a)(2).

(3) The Commission may not impose new

requirements by plant-specific order on Tier

2 information of a specific plant referencing

the design certification while the design

certification is in effect under §§ 52.55 or

52.61, unless:

(i) A modification is necessary to secure

compliance with the Commission’s

regulations applicable and in effect at the

time the certification was issued, or to assure

adequate protection of the public health and

safety or the common defense and security;

and

(ii) Special circumstances as defined in 10

CFR 50.12(a) are present.

(4) An applicant or licensee who references

the design certification may request an

exemption from Tier 2 information. The

Commission may grant such a request only

if it determines that the exemption will

comply with the requirements of 10 CFR

50.12(a). The granting of an exemption on

request of an applicant must be subject to

litigation in the same manner as other issues

in the construction permit, operating license,

or combined license hearing.

(5)(i) An applicant or licensee who

references the design certification may depart

from Tier 2 information, without prior NRC

approval, unless the proposed change

involves a change to Tier 1 or Tier 2*

information, as identified in the DCD, the

technical specifications, or an unreviewed

safety question as defined in paragraphs

(b)(5)(ii) or (b)(5)(iii) of this section. When

evaluating the proposed change, an applicant

or licensee shall consider all matters

described in the DCD, including generic

issues and shutdown risk for all postulated

accidents including severe accidents. These

changes will no longer be considered

‘‘matters resolved in connection with the

issuance or renewal of a design certification’’

within the meaning of 10 CFR 52.63(a)(4).

(ii) A proposed departure from Tier 2

information, other than severe accident

issues identified in Section 19E of the DCD,

including attachments EA through EE, must

be deemed to involve an unreviewed safety

question if:

(A) The probability of occurrence or the

consequences of an accident or malfunction

of equipment important to safety previously

evaluated in the DCD may be increased;

(B) A possibility for an accident or

malfunction of a different type than any

evaluated previously in the DCD may be

created; or

(C) The margin of safety as defined in the

basis for any technical specification is

reduced.

(iii) A proposed departure from

information associated with severe accident

issues identified in Section 19E of the DCD,

including attachments EA through EE, must

be deemed to involve an unreviewed safety

question if:

(A) There is a substantial increase in the

probability of a severe accident such that a

particular severe accident previously

reviewed and determined to be not credible

could become credible; or

(B) There is a substantial increase in the

consequences to the public of a particular

severe accident previously reviewed.

(iv) Departures from Tier 2 information

made in accordance with Section 8(b)(5)

above do not require an exemption from this

design certification rule.

(c) Other requirements of this design

certification rule.

An applicant or licensee who references

the design certification may not depart from

this rule’s requirements, other than Tier 1 or

2 information, other than by an exemption in

accordance with 10 CFR 50.12.

9. Records and reports.

(a) Records.

(1) The applicant for this design

certification shall maintain a copy of the DCD

that includes all generic changes to Tier 1

and Tier 2 information.

(2) An applicant or licensee that references

this design certification shall maintain

records of all changes to and departures from

the DCD pursuant to Section 8 of this

appendix. Records of changes made pursuant

to Section 8(b)(5) must include a written

safety evaluation which provides the bases

for the determination that the proposed

change does not involve an unreviewed

safety question, a change to Tier 1 or Tier 2*

information, or a change to the technical

specifications.

(b) Reports. An applicant or licensee that

references this design certification shall

submit a report to the NRC, as specified in

10 CFR 50.4, containing a brief description of

any departures from the DCD, including a

summary of the safety evaluation of each. An

applicant or licensee shall also submit

updates to the DCD to ensure that the DCD

contains the latest material developed for

both Tier 1 and 2 information. The

requirements of 10 CFR 50.71 for safety

analysis reports must apply to these updates.

These reports and updates must be submitted

at the frequency specified below:

(1) During the interval from the date of

application to the date of issuance of either

a construction permit under 10 CFR part 50

or a combined license under 10 CFR part 52,

the report and any updates to the DCD may

be submitted along with amendments to the

application.

(2) During the interval from the date of

issuance of either a construction permit

under 10 CFR part 50 or a combined license

under 10 CFR part 52 until the applicant or

licensee receives either an operating license

under 10 CFR part 50 or the Commission

makes its findings under 10 CFR 52.103, the

report must be submitted quarterly. Updates

to the DCD must be submitted annually.

(3) Thereafter, reports and updates to the

DCD may be submitted annually or along

with updates to the safety analysis report for

the facility as required by 10 CFR 50.71, or

at such shorter intervals as may be specified

in the license.

(c) Retention period. The DCD, and the

records of changes to and departures from the

DCD must be maintained until the date of

termination of the construction permit or

license.

Dated at Rockville, MD, this 31st day of

March 1995.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 95–8379 Filed 4–6–95; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

10 CFR PART 52

RIN 3150–AF15

Standard Design Certification for the

System 80+ Design

AGENCY: Nuclear Regulatory

Commission.

ACTION: Proposed rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC or Commission)

proposes to approve by rulemaking a

standard design certification for the

System 80+ design. The applicant for

certification of the System 80+ design

was Asea Brown Boveri-Combustion

Engineering (ABB–CE). The NRC is