Standard Design Certification for the System 80+ Design

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.

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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

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 System 80+ 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 System 80+ 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.

ommission 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

ovmassian, 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 `` 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

ed].

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 March 30, 1989, Combustion Engineering, Inc. (ABB-CE) applied

for certification of the System 80+ 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.

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 August 21, 1989, ABB-CE 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. The application was docketed on

May 1, 1991, and assigned Docket No. 52-002

licensing issues and to enhance the safety

and reliability of nuclear power plants.

On August 21, 1989, ABB-CE 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. The application was docketed on

May 1, 1991, and assigned Docket No. 52-002. Correspondence relating to

the application prior to this date was also addressed to docket number

STN 50-470 and Project No. 675. ABB-CE's application, the Combustion

Engineering Standard Safety Analysis Report--Design Certification

(CESSAR-DC) up to and including amendment W and the Certified Design

Material, is available for inspection and copying at the NRC Public

Document Room. By letter dated May 26, 1992, Combustion Engineering,

Inc. notified the NRC that it is a wholly owned subsidiary of Asea

Brown Boveri, Inc., and the appropriate abbreviation for the company is

ABB-CE.

The NRC staff issued a final safety evaluation report (FSER)

related to the certification of the System 80+ design in August 1994

(NUREG-1462). The FSER documents the results of the NRC staff's safety

review of the System 80+ 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, U.S. Government Printing

Office, Mail Stop SSOP, Washington, DC 20402-9328 or the National

Technical Information Service, Springfield, VA 22161. The final design

approval (FDA) for the System 80+ design was issued on July 26, 1994,

and published in the Federal Register on August 2, 1994 (59 FR 39371).

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

nal design

approval (FDA) for the System 80+ design was issued on July 26, 1994,

and published in the Federal Register on August 2, 1994 (59 FR 39371).

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

e 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 Panel in a design certification rulemaking. While Part 52

describes a general framework for conducting a design certification

rulemaking, Sec. 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)

nd 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.

\1\AECL is the vendor for the CANDU 3 design.

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ois 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.

\1\AECL is the vendor for the CANDU 3 design.

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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 staff-proposed positions or

recommendations

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 staff-proposed 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 System 80+ 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 two-tiered structure

for design information. 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. The following

is a summary and resolution of the public comments:

Topic 1--Acceptability of a Two-Tiered Design Certification Rule

Structure

Comment Summary. On behalf of the nuclear industry, NEI stated that

a two-tiered 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

of the nuclear industry, NEI stated that

a two-tiered 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

ent. 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 ``Sec. 50.59-like''

change process. However, NEI does not agree with the statement in the

ANPR (A.13(d)(3)) that ``changes properly implemented through this

``Sec. 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 ``Sec. 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

``Sec

l-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

``Sec. 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

nges 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 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 NRC 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 applicant or licensee may request, and the NRC may grant, an

exemption to Tier 2 information

design certification rulemaking.

Therefore, the NRC 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 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

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

``Sec. 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

``Sec. 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

L 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

``Sec. 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 (ITACC), 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

mpletion of designs and the inspections, tests, analyses, and

acceptance criteria (ITACC), 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 so-called 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

e 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 agrees 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 changes after the plant is

completed. The appropriate expiration point is designated in the DCD

on 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 changes after the plant is

completed. The appropriate expiration point is designated in the DCD.

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 Sec. 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, Sec. 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

Sec

he 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

Sec. 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 provides 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

e 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

alent 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

andard 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 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

accidents

and in other selected areas. The NRC staff proposed new 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 Secs. 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

Sec. 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 Secs. 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 Sec. 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

Sec. 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

lations 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

Sec. 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

Sec. 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 Sec. 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 Sec. 52.54.

By identifying the regulations that are applicable to each design,

the Commission has improved the stability and predictability of the

licensing process

ith 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 Sec. 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

thm 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

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 as built 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 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

e NRC

staff met with NEI on January 6, 1994, and issued a letter to NEI on

May 3, 1994, that 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

d 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 B 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 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, 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

fied design. If the COL applicant 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, 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 and 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 Sec. 52.8, Section 3 to the rule is no longer necessary.

D. Contents of the Design Certification

llection 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 Sec. 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 design-related 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

he 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 (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 may 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 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 below in Section H, ``Change Process.'' 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 design-related 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

sign,

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

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 design-related information contained

in the DCD that is approved by this rule but is not certified. The

change process defines the procedural differences between Tier 1 and 2.

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

t 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. 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 site-specific 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

n 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 Commission'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 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. The proprietary information,

or its equivalent, that was provided in the design certification

application by reference but not included in the DCD, must be included

as part of a COL application. The Commission considers this information

to be requirements for plants that reference this rule

ds information. This information was part of the NRC staff's

bases for its safety findings in the FSER. The proprietary information,

or its equivalent, that was provided in the design certification

application by reference but not included in the DCD, must be included

as part of a COL application. The Commission considers this information

to be requirements for plants that reference this rule. Since the

proprietary 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 design acceptance criteria (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 Commission 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

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

licant

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,'' 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 these 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

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

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 Sec. 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 Sec. 52.54. Also, without

codification of the applicable regulations, the NRC could not perform

its reviews in accordance with Secs. 52.59 and 52.63. By codifying

these requirements, the NRC intends that for renewal of a certified

design under Sec

hout further Commission action, could be

argued as not being ``applicable standards and requirements of the * *

* Commission's regulations'' under Sec. 52.54. Also, without

codification of the applicable regulations, the NRC could not perform

its reviews in accordance with Secs. 52.59 and 52.63. By codifying

these requirements, the NRC intends that for renewal of a certified

design under Sec. 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 Sec. 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 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 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 design-

specific (applicable) regulations is not workable for proposed changes

because the design information only represents one way of implementing

a regulation

tion 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 design-

specific (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 Sec. 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 Sec. 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

l

assessment or the severe accident design alternatives in the

applicant's Technical Support Document are also resolved within the

scope and intent of Sec. 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

s 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 this 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 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).

he

change process developed by the Commission in the 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).

\2\This 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.

---------------------------------------------------------------------------

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, plant-specific 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 Sec. 52.63, whereas Sec. 50.109 would

govern backfitting as respects the second tier.'' As a result, the NRC

staff used the backfit standards in Sec. 50.109 for generic changes to

Tier 2 in its proposed design certification rule in SECY-92-287

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 Sec. 52.63, whereas Sec. 50.109 would

govern backfitting as respects the second tier.'' As a result, the NRC

staff used the backfit standards in Sec. 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

proposes in Section 8(a)(3) that plant-specific orders or exemptions

from Tier 1 information must consider whether the special circumstances

which Sec. 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 is not proposing 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

ves 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

Section III.D). Under Sections 8 (a)(2) and (b)(2), generic changes to

Tier 1 and Tier 2, respectively, will be applicable to all plants

referencing the design certification. However, if the Commission

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

ulation

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 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 ``Sec

ges 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 ``Sec. 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 Commission

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

tion 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

Commission does 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 cannot be changed without

prior NRC approval

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 cannot 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 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

ation 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

chnical

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 19.15 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))

o 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)

ntified 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

fication 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 Sec. 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 up-to-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

rmation

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 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

ant 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 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

g 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 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

Sec. 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.)

nces 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 Secs. 52.41, 52.55(b), 52.55(c), 52.63(a)(4), 52.63(b)(1).

However, these provisions of 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

Sec. 52.63(c) (quoted above) and Sec. 52.55(c) explicitly provide for

referencing of design certification rules in 10 CFR part 50

construction permit proceedings, Secs. 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 Sec. 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

pplicant 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 10 CFR 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

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 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

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

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?

izes 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 pPart 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

icant for an operating license under 10 CFR pPart 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.

\3\An opportunity for public comment is required by Section 553

of the Administrative Procedures Act and 10 CFR 52.51(b).

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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)

at (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 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

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;

e-mail AXD[email protected].

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

e 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).

\4\An opportunity for a hearing is provided by 10 CFR 52.51(b).

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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. Charles B. Brinkman, Director, Nuclear Systems Licensing,

ABB-Combustion Engineering, Inc., P.O. Box 500, 1000 Prospect Hill

Road, Windsor, CT 06095-0500

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. Charles B. Brinkman, Director, Nuclear Systems Licensing,

ABB-Combustion Engineering, Inc., P.O. Box 500, 1000 Prospect Hill

Road, Windsor, CT 06095-0500. 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.

ter 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.

\5\Filings 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. These 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.

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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:

xt 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:

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

(iii) An understanding of the NRC's hearing procedures in 10 CFR

part 2.6

\6\Requestors will satisfy this requirement by stating that they

possess and have read a copy of 10 CFR part 2, subparts A, G, and L.

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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

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:

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:

n 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,

nce 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

nalogous 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 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

ings 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

ted 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:

n 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

ts 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 there are several docket files in which the

NRC staff has placed information and documents received from the design

certification applicant for the System 80+ design certification review.

The application was docketed on May 1, 1991 and assigned Docket No. 52-

002. Correspondence relating to the application prior to this date was

also addressed to Docket No. STN 50-470 and Project No. 675. This

information includes the Design Control Document and the Technical

Support Document for Amendments to 10 CFR part 51 Considering Severe

Accidents Under NEPA for Plants of the System 80+ Design, Revision 2.

Furthermore, the docket files contain NRC staff communications and

documents, such as written questions and comments provided to the

design certification app

This text is long and has been trimmed here. Open the source document for the complete record.