[Federal Register Volume 60, Number 67 (Friday, April 7, 1995)]
[Proposed Rules]
[Pages 17924-17947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8380]



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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 
[[Page 17925]] 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.

ADDRESSES: Mail written comments and requests for an informal hearing 
to: The Secretary of the Commission, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555, Attention: Docketing and Service 
Branch. Comments may also be delivered to 11555 Rockville Pike, 
Rockville, MD, between 7:30 am and 4:15 pm on Federal workdays. Copies 
of comments received will be available for examination and copying at 
the NRC Public Document Room (PDR) at 2120 L Street NW. (Lower Level), 
Washington, DC. A copy of the environmental assessment and the design 
control document is also available for examination and copying at the 
PDR.

FOR FURTHER INFORMATION CONTACT: Harry S. Tovmassian, Office of Nuclear 
Regulatory Research, telephone (301) 415-6231, Jerry N. Wilson, Office 
of Nuclear Reactor Regulation, telephone (301) 415-3145, or Geary S. 
Mizuno, Office of the General Counsel, telephone (301) 415-1639, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background.
II. Public comment summary and resolution.
    Topic 1--Acceptability of a Two-Tiered Design Certification Rule 
Structure
    Topic 2--Acceptability of the Process and Standards for Changing 
Tier 2 Information
    Topic 3--The Acceptability of a Tier 2 Exemption
    Topic 4--Acceptability of Using a Change Process, Similar to the 
One in 10 CFR 50.59 Applicable to Operating Reactors, Prior to the 
Issuance of a Combined License that References a Certified Design
    Topic 5--The Acceptability of Identifying Selected Technical 
Positions from the FSER as ``Unreviewed Safety Questions'' that 
Cannot Be Changed Under a `` 50.59-Like'' Change Process
    Topic 6--Need for Modifications to 10 CFR 52.63(b)(2) If the 
Two-Tiered Structure for the Design Certification Rule Is Approved
    Topic 7--Whether the Commission Should Either Incorporate or 
Identify the Information in Tier 1 or Tier 2 or Both in the Combined 
License
    Topic 8--Acceptability of Using Design Specific Rulemakings 
Rather Than Generic Rulemaking for the Technical Issues Whose 
Resolution Exceeds Current Requirements
    Topic 9--The Appropriate Form and Content of a Design Control 
Document
III. Section-by-section discussion of design certification rule.
    A. Scope.
    B. Definitions.
    C. [Reserved].
    D. Contents of the design certification.
    E. Exemptions and applicable regulations.
    F. Issue resolution for the design certification.
    G. Duration of the design certification.
    H. Change process.
    I. Records and reports.
    J. Applicability of a DCR in 10 CFR Part 50 licensing 
proceedings.
IV. Specific requests for comments.
V. Comments and hearings in the design certification rulemaking.
    A. Opportunity to submit written and electronic comments.
    B. Opportunity to request hearing.
    C. Hearing process.
    D. Resolution of issues for the final rulemaking.
    E. Access to proprietary information in rulemaking.
    F. Ex parte and separation of functions restrictions.
VI. Finding of no significant environmental impact: availability.
VII. Paperwork Reduction Act statement.
VIII. Regulatory analysis.
IX. Regulatory Flexibility Act certification.
X. Backfit analysis.

I. Background

    On 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. 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. 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 [[Page 17926]] put 
forth by the Commission, and to specific questions raised by 
Commissioner Curtiss in a letter dated September 9, 1992. Subsequently, 
the NRC staff modified the draft rule in SECY-92-287 to incorporate 
Commission guidance and published a draft-proposed design certification 
rule in the Federal Register on November 3, 1993 (58 FR 58665), as an 
Advanced Notice of Proposed Rulemaking (ANPR) for public comment. On 
November 23, 1993, the NRC staff discussed this ANPR in a public 
workshop entitled ``Topics Related to Certification of Evolutionary 
Light Water Reactor Designs.'' All holders of operating licenses or 
construction permits were informed of the issuance of the ANPR and the 
planned public workshop through the issuance of NRC Administrative 
Letter 93-05 on October 29, 1993. Separate announcements of the 
workshop were also sent to the Union of Concerned Scientists, the 
Nuclear Information and Resource Service, the Natural Resources Defense 
Council, the Public Citizen Litigation Group, the Ohio Citizens for 
Responsible Energy (OCRE), and the State of Illinois Department of 
Nuclear Safety on October 18, 1993. An official transcript of the 
workshop proceedings is available in the PDR.

Rulemaking Procedures

    10 CFR part 52 provides for Commission approval of standard designs 
for nuclear power facilities (e.g., design certification) through 
rulemaking. In accordance with the Administrative Procedure Act (APA), 
part 52 provides the opportunity for the public to submit written 
comments on the proposed design certification rule. However, Part 52 
goes beyond the requirements of the APA by providing the public with an 
opportunity to request a hearing before the Atomic Safety and Licensing 
Board 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). 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.<SUP>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. 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 
[[Page 17927]] challenge in the standard design certification and any 
associated hearing.
    Response. Although a two-tiered structure for design certification 
rules was not envisioned or subsequently deemed necessary to implement 
standard design certifications under 10 CFR part 52, the Commission 
approved the use of a two-tiered structure for a design certification 
rule in its SRM of February 15, 1991, on SECY-90-377, ``Requirements 
for Design Certification Under 10 CFR Part 52,'' in response to a 
request from NEI dated August 31, 1990. Since then, the NRC staff has 
worked to develop a two-tiered rule that achieves industry's goal of 
issue preclusion for a greater amount of information than was 
originally planned for design certification, while retaining 
flexibility for design implementation.
    Tier 1 information is defined in Section 2(b) of the proposed rule 
and is treated as the certified information that is controlled by the 
change standards of 10 CFR 52.63. Tier 2 information is defined in 
Section 2(c) of the proposed rule and consists primarily of the 
information submitted in an application for design certification. The 
information in the two tiers is interdependent. Therefore, an applicant 
for a construction permit, operating license, or combined license (COL) 
that references this design certification must reference both tiers of 
information. The consolidation of both tiers of information into a 
Design Control Document (DCD) will provide an effective means of 
maintaining this information and facilitating its incorporation into 
the rule by reference. All matters covered in each tier, including the 
determination of what information should be placed in each tier, are 
subject to public challenge in the design certification rulemaking and 
any associated hearing.
Topic 2--Acceptability of the Process and Standards for Changing Tier 2 
Information
    Comment Summary. NEI concurs in the process and standards to be 
used by COL holders and applicants for evaluating and implementing 
changes to Tier 2 information via the so-called ``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. 50.59-like'' process will no longer be afforded the issue 
preclusion protection of 10 CFR 52.63. To do otherwise would turn the 
two-tiered system into a double standard in which utilities could 
deviate from the standard design but the public could not challenge 
these deviations. Permitting site-specific litigation of these changes 
would also serve to discourage changes.
    Response. In order to implement the two-tiered structure for design 
certification rules, the Commission proposes a change process for Tier 
2 information that has the same elements as the Tier 1 change process. 
Specifically, the Tier 2 change process has provisions for generic 
changes, plant-specific changes, and exemptions similar to those in 10 
CFR 52.63. Although the NRC staff proposed that the backfitting 
standards for making generic changes to Tier 2 information should be 
less stringent than those for Tier 1 information, the Commission 
disapproved this proposal in its SRM on SECY-92-287A, dated June 13, 
1993, and stated that ``the backfitting standards of 10 CFR 52.63 
should be applied for such changes to Tier 2.'' As a result, the NRC 
staff adopted the backfitting standards of 10 CFR 52.63 in the Tier 2 
change process proposed in the ANPR, except that the additional factor 
regarding ``any decrease in safety that may result from the reduction 
in standardization'' was not adopted for plant-specific changes and 
exemptions in order to achieve additional flexibility for Tier 2 
information.
    The Tier 2 change process also has a provision similar to 10 CFR 
50.59 that allows changes to Tier 2 information by an applicant or 
licensee, without prior NRC approval, subject to certain restrictions. 
The Commission approved this process in its SRM on SECY-90-377, dated 
February 15, 1991, provided ``that such changes open the possibility 
for challenge in a hearing.'' The NRC staff followed the Commission's 
guidance in developing the process in ANPR 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. 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. 
[[Page 17928]] 
    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.
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. 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.
    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.
    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 [[Page 17929]] 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.
Topic 8--Acceptability of Using Design Specific Rulemakings Rather Than 
Generic Rulemaking for the Technical Issues Whose Resolution Exceeds 
Current Requirements
    Comment Summary. NEI, GE Nuclear Energy, and Westinghouse Electric 
Corporation took exception with the NRC position on the issue of 
designating severe accident and technical requirements, beyond those in 
current regulations, as ``applicable regulations'' in the design 
certification rule. NEI stated that ``Commission approved NRC staff 
positions will be reflected in a design certification rule by means of 
design provisions contained in Tier 1 and Tier 2 of the DCD 
incorporated in the rule.'' NEI argued that the NRC staff's proposed 
approach would result in needless duplication, complexity, and delay 
because matters that have been agreed to in detail would then be 
formulated in broadly stated positions requiring another round of 
extensive discussions to reach agreement in a process equivalent to a 
series of complex, discrete rulemakings. In addition, NEI stated that 
these ``broadly stated, free standing applicable regulations carry the 
potential for new and diverse interpretations by the NRC staff during 
the life of the design certification.'' These interpretations may be at 
odds with the understandings that translated into specific Tier 1 and 
Tier 2 requirements in the DCD. GE Nuclear Energy reiterated these 
comments but added that ``The course proposed by the NRC staff would 
enormously complicate pre-rulemaking preparation, the conduct of the 
rulemakings themselves and COL licensing and post-licensing facility 
construction and operation. It would, moreover, impose schedule delays 
and generate needless duplication, if not outright conflicts.'' Also, 
NEI saw little difference between the proposal to incorporate 
applicable regulations in design certification rules and the similar 
effect of proceeding with generic severe accident rulemaking.
    OCRE stated that the resolution of technical issues whose 
resolution exceeds current requirements will likely be design-specific 
and therefore, it may make little difference whether the rulemakings 
are design-specific or generic. OCRE further stated that, if the NRC 
wants all plants constructed after a certain date to incorporate 
certain design features or otherwise address certain technical issues, 
then a generic rulemaking may be the safest and most cost-effective way 
to accomplish this goal. OCRE also noted that a generic rule would 
cover an applicant that might decide not to use a standard certified 
design.
    Response. The Commission has used design-specific rulemaking rather 
than generic rulemaking for the selected technical and severe accident 
issues that go beyond current requirements for light-water reactors 
(LWRs). The Commission adopted this approach, early in the review 
process, because it believed that the new requirements would be design-
specific, as OCRE stated. Also, the NRC was concerned that generic 
rulemakings would cause significant delay in the design certification 
reviews. The Commission approved this approach in its SRM on SECY-91-
262, dated January 28, 1992, and has continued to support this approach 
for evolutionary LWRs, as stated in its SRM on SECY-93-226, dated 
September 14, 1993. The Commission has deferred its decision on the 
need for generic rulemaking for advanced LWRs.
    Both the industry and OCRE concluded that there would be little 
difference in the requirements for the certified designs, regardless if 
the approach was generic or design-specific. The Commission agrees that 
at the conclusion of the design certification rulemaking the effect of 
the new regulations is basically the same but that the specific wording 
of the regulations may have been different if generic rulemaking was 
used.
    In implementing the goals of 10 CFR part 52 and the Commission's 
Severe Accident Policy Statement (50 FR 32138; August 8, 1985), the NRC 
staff set out to achieve a higher level of safety performance for both 
evolutionary and passive LWR designs in the area of severe accidents 
and in other selected areas. The NRC staff proposed new 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. The rationale is that the Commission 
could not, without [[Page 17930]] 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. By approving the design information that describes 
how these regulations were met, the Commission has minimized the 
potential for a differing interpretation of the regulations. Finally, 
the NRC staff told NEI in a meeting on April 25, 1994, and in a letter 
dated July 25, 1994, that the industry-proposed alternative to 
applicable regulations was unacceptable. The NRC staff stated that 
design information cannot function as a surrogate for design-specific 
(applicable) regulations because this information describes only one 
method for meeting the regulation and would not provide a basis for 
evaluating proposed changes to the design information. Therefore, 
consideration of the comments on Topic #8 has not altered the 
Commission's decision to proceed with design-specific rulemaking for 
the proposed requirements and to publish the appropriate applicable 
regulations in each design certification rule.
Topic 9--The Appropriate Form and Content of a Design Control Document
    Comment Summary. Concerning the form and content of the DCD, NEI 
envisioned a document that consisted of three parts including an 
introductory section, Tier 1 information, and Tier 2 information. NEI 
also proposed an algorithm that described the industry's view of the 
contents of a DCD.
    NEI stated that, based on its interactions with the NRC staff on 
the guidance for preparing a DCD, two main issues have emerged. The 
first issue is the nature and treatment for rulemaking purposes of 
secondary references contained in the DCD. At issue is the extent to 
which references to codes, standards, Regulatory Guides, etc. need to 
be explicitly ``incorporated by reference'' in specific design 
certification rules (DCRs). It is industry's position that the burden 
of incorporating these secondary references into the rule would 
outweigh the increase in regulatory certainty and predictability that 
such an effort would provide. The second issue relates to the 
regulatory significance of information contained in the DCD and, in 
particular, design Probabilistic Risk Assessment (PRA) information. 
Specifically, NEI is concerned with the inclusion of the design PRA in 
the DCD and a perceived requirement to use the PRA to support the 
``50.59-like'' change process.
    Response. As defined in SECY-92-287, the DCD is the master document 
that contains the Tier 1 and 2 information referenced by the design 
certification rule. The NRC staff has had several meetings with the 
design certification applicants on the preparation of a DCD and 
provided guidance to the applicants in letters dated August 26, 1993; 
August 3 and 5, 1994; and October 4, 1994. Although the Commission 
agrees with NEI on the basic form of the DCD, it does not agree with 
NEI's proposed algorithm on the contents of a DCD.
    Because the DCD is the master reference document, it should, to the 
extent possible, retain as much of the applicant's standard safety 
analysis report (SSAR), as required in 10 CFR 52.47. Due to the 
requirement that all information incorporated in the rule be publicly 
available, proprietary and safeguards information cannot be included in 
the DCD. Also, the NRC concluded that the detailed methodology and 
quantitative portions of the design PRA do not need to be included in 
the DCD but the assumptions, insights, and discussions of PRA analyses 
must be retained in the DCD. The NRC also decided that COL applicants 
and licensees will be encouraged, but not required, to use the PRA to 
support the change process. This position was predicated in part upon 
NEI's acceptance, in conceptual form, of a future generic rulemaking 
that requires a COL applicant or holder to have a plant-specific PRA 
that updates and supersedes the design PRA to account for site-specific 
and detailed 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. 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 [[Page 17931]] Commission guidance, 
and an updated version was published in appendix 2 to the ANPR. The 
proposed rule in this Federal Register notice has the same basic form 
and content as the ANPR version, but there has been some reorganization 
of the contents. The following discusses the purpose and key aspects of 
each section of the rule and also discusses issues raised on those 
sections that are not covered in the public comment summary. Changes 
made to the ANPR version of the proposed rule for the sake of clarity, 
brevity, consistency, or organization are not discussed below. All 
references to the proposed rule are to the provisions in proposed 
appendix 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

    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

    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. 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 
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 
[[Page 17932]] material applicable to multiple systems of the design, 
significant interface requirements, and significant site parameters for 
the design. The NRC staff's evaluation of the Tier 1 information, 
including a description of how this information was developed is 
provided in Section 14.3 of the FSER.
    The information in the Tier 1 portion of the DCD was extracted from 
the detailed information contained in the application for design 
certification. The Tier 1 information addresses the most safety-
significant aspects of the design, and was organized primarily 
according to the structures and systems of the design. Additional 
design material and related ITAAC is also provided in Tier 1 for 
selected design and construction activities that are applicable to 
multiple systems of the design. The Tier 1 design descriptions serve as 
design commitments for the lifetime of a facility referencing the 
design certification, and the ITAAC verify that the as-built facility 
conforms with the approved design and applicable regulations. In 
accordance with 10 CFR 52.103(g), the Commission must find that the 
acceptance criteria in the ITAAC are met before operation. After the 
Commission has made the finding required by 10 CFR 52.103(g), the ITAAC 
do not constitute regulatory requirements for subsequent modifications. 
However, subsequent modifications to the facility must comply with the 
Tier 1 design descriptions, unless changes are made in accordance with 
the change process in Section 8 of this proposed rule.
    The Tier 1 interface requirements are the most significant of the 
interface requirements for the standard design, which were submitted in 
response to 10 CFR 52.47(a)(1)(vii), that must be met by the site-
specific portions of a facility that references the design 
certification. The Tier 1 site parameters are the most significant site 
parameters, which were submitted in response to 10 CFR 
52.47(a)(1)(iii), that must be addressed as part of the application for 
a construction permit or COL.
    Tier 2 is the portion of the 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. 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. 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. 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). [[Page 17933]] 
    The purpose of Section 4(b) of this proposed rule is to ensure that 
an applicant that references this design certification references both 
tiers of information in the DCD. The two tiers of information were 
developed together and both tiers of information are needed to complete 
the design of a plant that references the rule. For example, the ITAAC 
in Tier 1 contains not only the acceptance criteria for verifying that 
the as-built plant conforms with the approved design, but it also 
contains various design processes with acceptance criteria (DAC), for 
completing selected areas of the plant design. The DAC are described in 
Section 14.3 of the SSAR and FSER. The NRC staff relied on DAC for its 
evaluation of selected design areas where the applicant for design 
certification did not provide complete design information. Also, the 
Tier 2 information contains explanations and procedures on how to 
implement ITAAC. Therefore, the Commission proposes that an applicant 
could not reference this design certification rule without meeting 
ITAAC, even though it is not a requirement in 10 CFR part 50. (see 
Section J for further discussion)
    The applicant for design certification initially prepared the DCD 
to be consistent with the SSAR and the NRC staff's FSER. The applicant 
for design certification made some corrections and clarifications to 
the DCD since the completion of the SSAR and issuance of the FSER. If 
there is an inconsistency between the SSAR and the FSER, or between 
either of these documents and the DCD, then the DCD is the controlling 
document. That is the purpose of Section 4(c) of this proposed rule.

E. Exemptions and Applicable Regulations

    The purpose of Section 5 of the proposed rule entitled, 
``Exemptions and applicable regulations,'' 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. As a result, the NRC staff proposed new requirements in 
various Commission papers, such as SECY-90-016 and SECY-93-087, to be 
used in the design certification review and treated as applicable 
regulations in the design certification rulemaking (refer to discussion 
on Topic #8). The bases for these requirements are set forth in SECY-
90-016 and SECY-93-087. The Commission approved the use of these 
proposed regulations for purposes of the design certification review in 
the respective SRMs. These proposed regulations deviated from or were 
not embodied in current regulations applicable to the standard design. 
The NRC staff then selected proposed regulations that were applicable 
to the design under review and reviewed the design pursuant to these 
applicable regulations. The FSER identifies the applicable regulations 
that were used and describes how these regulations were met by the 
design-related information in the SSAR. The Commission approved the 
evaluation of the design pursuant to the applicable regulations in its 
approval to publish the FSER.
    These proposed applicable regulations are identified in Section 
5(c) of this proposed rule to achieve codification through the design 
certification rulemaking. The proposed applicable regulations in 
Section 5(c) are substantively the same as those in the FSER but have 
been edited for clarity. These codified requirements, which supplement 
the regulations in Section 5(b), will become part of the Commission's 
regulations that were ``applicable and in effect at the time the 
certification was issued,'' if the Commission adopts them in the final 
design certification rule. The Commission requests comments on whether 
each specific applicable regulation is justified (refer to Section IV).
    The codification of these additional requirements, in reference to 
10 CFR 52.48, is necessary for two reasons. First, it serves as a basis 
for obtaining public comment on the adoption of the proposed 
requirements as applicable regulations. Second, it provides 
confirmation that the requirements are being adopted by the Commission 
as applicable regulations under 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. 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. The NRC would need the regulation for [[Page 17934]] 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

    The purpose of Section 7 of the proposed rule entitled, ``Duration 
of the Design Certification,'' is in part to specify the time period 
during which the standard design certification may be referenced by an 
applicant for a construction permit or COL, pursuant to 10 CFR 52.55. 
This section of the rule also states that the design certification 
remains valid for an applicant or licensee that references the design 
certification until their application is withdrawn or their license 
expires. Therefore, if an application references this design 
certification during the 15-year period, then the design certification 
rule continues in effect until the application is withdrawn or the 
license issued on that application expires. Also, the design 
certification continues in effect for the referencing license if the 
license is renewed. The Commission intends for the proposed rule to 
remain valid for the life of the plant that references the design 
certification to achieve the benefits of standardization and licensing 
stability. This means that rulemaking changes to or plant-specific 
departures from information in the DCD must be made pursuant to the 
change process in Section 8 of this proposed rule for the life of the 
plant.

H. Change Process

    The purpose of Section 8 of 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.<SUP>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).

    \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.
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    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. 
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. 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 [[Page 17935]] violation of an underlying regulation 
that is applicable to this design certification, then an exemption to 
that regulation is also required.
    A plant-specific departure from either Tier 1 or 2 information in 
the DCD does not require rulemaking. Any person requesting a Commission 
order directing a plant-specific change, including the applicant for 
this design certification, must submit a petition pursuant to 10 CFR 
2.206. This petition must describe how the proposed change meets the 
standards in 10 CFR 52.63(a)(3) or Section 8(b)(3) for departures from 
Tier 1 or 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. 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. 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. 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. However, if an applicant or licensee requests NRC approval 
for a proposed change to Tier 2* information, should the NRC review 
process be similar to that for a USQ? While it is clear that these 
proposed changes would all involve significant design-related 
information and that prior review of proposed departures from Tier 2 
information is necessary, the NRC has not determined if it is always 
appropriate to process the approved changes as either an amendment to 
the license application or an amendment to the license, with the 
requisite hearing rights. Therefore, the NRC requests the public's view 
on the preferred regulatory process for these changes (refer to Section 
IV).
    An applicant or licensee that plans to depart from Tier 2 
information, pursuant to Section 8(b)(5), must prepare a safety 
evaluation which provides the bases for the determination that the 
proposed change does not involve an unreviewed safety question, a 
change to Tier 1 or Tier 2* information, or a change to the technical 
specifications. In order to achieve the Commission's goals for design 
certification, the evaluation needs to consider all of the matters that 
were resolved in the DCD, including the generic issues discussed in 
Chapter 20 of the FSER. The benefits of the early resolution of safety 
issues would be lost if changes were made to the DCD that violated 
these resolutions without NRC approval. The evaluation of the resolved 
issues needs to consider the proposed change over the full range of 
power operation from startup to shutdown, including issues resolved 
under the heading of shutdown risk, as it relates [[Page 17936]] 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)). GE argued that not all increases in the 
probability or consequences of severe accidents are significant from a 
safety standpoint. Minor increases in the probability of some accident 
scenarios will not affect the overall core damage frequency or the 
conclusions of the severe accident evaluations. Therefore, GE proposed 
that changes to Tier 2 information that result in insignificant 
increases in the probability or consequences of severe accidents not 
constitute a USQ.
    The NRC believes that it is important to preserve and maintain the 
resolution of severe accident issues just like all other safety issues 
that were resolved during the design certification review (refer to SRM 
on SECY-90-377). However, because of the increased uncertainty in 
severe accident issue resolutions, the NRC has proposed, in Section 
8(b)(5), separate criteria for determining whether a departure from 
information associated with severe accident issues constitutes a USQ. 
The new criteria in Section 8(b)(5)(iii) will only apply to Tier 2 
information that is associated with the severe accident issues 
discussed in the section of the DCD identified in the rule. The 
criteria for USQ determinations in Section 8(b)(5)(ii), which are the 
same as those proposed in the ANPR, will apply to other Tier 2 
information. If the proposed departure from Tier 2 information involves 
the resolution of other safety issues in addition to the severe 
accident issues, then the USQ determination should be based upon the 
criteria in Section 8(b)(5)(ii). The NRC is interested in the public's 
view on whether the Tier 2 information involving resolutions of severe 
accident issues should be treated differently for USQ determinations 
than all other safety issues? If so, are the proposed criteria in 
Section 8(b)(5)(iii) sufficient to determine if a proposed departure 
from information associated with severe accident issues constitutes a 
USQ? (Refer to Section IV.)
    The NRC is also proposing two additional provisions to the change 
process that were not in the ANPR. The first is Section 8(b)(5)(iv), 
which provides that changes made pursuant to Section 8(b)(5) do not 
also require an exemption from the design certification rule. Because 
the Tier 2 information is incorporated by reference into the design 
certification, a departure from Tier 2 pursuant to Section 8(b)(5) 
would also require an exemption from the design certification rule 
absent this proposed provision. The second provision is Section 8(c), 
which makes it clear that proposed changes to requirements in this 
design certification rule that are neither Tier 1 nor Tier 2 must be 
done by exemption pursuant to 10 CFR 50.12. Such requirements include 
the recordkeeping and reporting requirements in Section 9 of this 
proposed rule.

I. Records and Reports

    The purpose of Section 9 of this proposed rule entitled, ``Records 
and Reports,'' is to set forth the requirements for maintaining records 
of DCD changes and submitting reports to the NRC. This section is 
similar to the requirements for records and reports in 10 CFR Part 50 
and 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. 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.
    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 [[Page 17937]] 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. 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.)

    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. 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.
    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. 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 [[Page 17938]] changes may be made under Section 8(b)(5)(i) 
without prior NRC approval be made available to the public in order for 
those determinations to be challenged or for the changes themselves to 
be challenged? (Refer to discussion in III.H.)
    7. What is the preferred regulatory process (including 
opportunities for public participation) for NRC review of proposed 
changes to Tier 2* information and the commenter's basis for 
recommending a particular process? (Refer to discussion in III.H.)
    8. Should determinations of whether proposed changes to severe 
accident issues constitute an unreviewed safety question use different 
criteria than for other safety issues resolved in the design 
certification review and, if so, what should those criteria be? (Refer 
to discussion in III.H.)
    9(a)(1) Should construction permit applicants under 10 CFR part 50 
be allowed to reference design certification rules to satisfy the 
relevant requirements of 10 CFR Part 50? (Refer to discussion in 
III.J.)
    (2) What, if any, issue preclusion exists in a subsequent operating 
license stage and NRC enforcement, after the Commission authorizes a 
construction permit applicant to reference a design certification rule?
    (3) Should construction permit applicants referencing a design 
certification rule be either permitted or required to reference the 
ITAAC? If so, what are the legal consequences, in terms of the scope of 
NRC review and approval and the scope of admissible contentions, at the 
subsequent operating license proceeding?
    (4) What would distinguish the ``old'' 10 CFR part 50 2-step 
process from the 10 CFR part 52 combined license process if a 
construction permit applicant is permitted to reference a design 
certification rule and the final design and ITAAC are given full issue 
preclusion in the operating license proceeding? To the extent this 
circumstance approximates a combined license, without being one, is it 
inconsistent with Section 189(b) of the Atomic Energy Act (added by the 
Energy Policy Act of 1992) providing specifically for combined 
licenses?
    9(b)(1) Should operating license applicants under 10 CFR part 50 be 
allowed to reference design certification rules to satisfy the relevant 
requirements of 10 CFR part 50? (Refer to discussion in III.J.)
    (2) What should be the legal consequences, from the standpoints of 
issue resolution in the operating license proceeding, NRC enforcement, 
and licensee operation if a design certification rule is referenced by 
an applicant for an operating license under 10 CFR 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.<SUP>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). 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. 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<a href="/cdn-cgi/l/email-protection#d0e390bea2b3feb7bfa6"><span class="__cf_email__" data-cfemail="182b58766a7b367f776e">[email protected]</span></a>.
Public Meeting
    The NRC staff plans to conduct a public meeting on this proposed 
rule on May 11, 1995, at the NRC Auditorium in Two White Flint North. 
Further details on the meeting are provided in a document published in 
this issue of the Federal Register. The purpose of the public meeting 
will be to discuss this proposed rule and respond to questions on the 
meaning and intent of any provisions of this proposed rule. It is hoped 
that this meeting will be helpful to persons who intend to submit 
written comments on the proposed rule. An official transcript of the 
proceedings of the public meeting will be prepared.

B. Opportunity to Request Hearing

    Any person may request an informal hearing on one or more specific 
matters with respect to the proposed design certification rule.<SUP>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 
[[Page 17939]] 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. 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.<SUP>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:
    (i) Identify the specific portion of the proposed design 
certification rule or supporting bases which are challenged,
    (ii) Describe the reasons why the proposed rule or supporting bases 
are incorrect or insufficient, and
    (iii) Identify the references or sources upon which the person 
requesting the hearing relies.
    If the requestor has submitted written comments in the public 
comment period addressing these three factors for the specific issue 
for which the requestor seeks a hearing, it will be sufficient for the 
requestor to identify the portions of the written comments which the 
requestor intends to submit as a written presentation. Also, the 
hearing request must demonstrate that the requestor (or other persons 
identified in the hearing request who will represent, assist, or speak 
on behalf of the requestor at the hearing) has appropriate knowledge 
and qualifications to enable the requestor to contribute significantly 
to the development of the hearing record on the specific matters at 
issue. The Commission does not intend that the requestor meet a 
judicial ``expert witness'' standard in order to meet the second 
criterion. Nonetheless, given the substantial commitment of time and 
resources associated with any hearing, the Commission believes it to be 
a reasonable prerequisite that the hearing requestor demonstrate that 
he/she (or his/her assistant) has:
    (i) Substantial familiarity with the publicly available docketed 
information relevant to the issue for which a hearing is requested;
    (ii) The requisite technical capability to understand the factual 
matters and develop a record on the issue for which a hearing is 
requested, and
    (iii) An understanding of the NRC's hearing procedures in 10 CFR 
part 2.<SUP>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. 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 [[Page 17940]] a hearing request. A written decision 
either granting or denying the hearing request will be published by the 
Commission.
    If a hearing request is granted in whole or in part, the 
Commission's decision will delineate the controverted matter that will 
be the subject of the hearing and whether any issues and/or parties are 
to be consolidated (see Section C.7. below). The Commission's decision 
granting the hearing will direct the establishment of a licensing board 
to preside over the informal hearing. Finally, the Commission's 
decision will specify:
    (i) The date by which any requests for discovery must be filed with 
the licensing board (normally 20 days after the date of the 
Commission's decision), and
    (ii) The date by which any objections to discovery must be filed 
(see Section C.9. below).
    The Commission's decision will be sent to each admitted party by 
overnight mail. Separate hearings may be granted for each controverted 
matter or set of consolidated matters. Thus, if there are three 
different controverted matters, the Commission may establish three 
separate hearings. In this fashion, closing of the hearing record on a 
controverted matter and its referral to the Commission for resolution 
need not await completion of the hearing on the other controverted 
matters. Finally, the Commission's decision will rule on any requests 
for hearings outside of the Washington, DC. metropolitan area (see 
Section C.3 above).
6. Authority of the Licensing Board
    If the Commission authorizes an informal hearing on a controverted 
matter, the licensing board will function as a ``limited magistrate'' 
in that hearing with the authority and responsibility for assuring that 
a sufficient record is developed on those controverted matters which 
the Commission has determined are appropriate for consideration in that 
hearing. The licensing board shall have the following specific 
responsibilities and authority:
    (i) Schedule and expeditiously conduct the informal hearing for 
each admitted controverted matter, consistent with the rights of all 
the parties,
    (ii) Review all discovery requests against the criteria established 
by the Commission, and refer all appropriate requests to the Commission 
with a decision explaining the licensing board's action,
    (iii) Preside over and resolve any issues regarding the scheduling 
and conduct of any discovery authorized by the Commission,
    (iv) Order such further consolidation of parties and issues as the 
licensing board determines is necessary or desirable,
    (v) Orally examine persons making oral presentations in the 
informal hearing, based in part upon the licensing board's review of 
the parties' proposed oral questions to be asked of persons making oral 
presentations,
    (vi) Request that the NRC staff:
    (A) Answer licensing board questions about the SER or the proposed 
rule,
    (B) Provide additional information or documentation with respect to 
the design certification, and
    (C) Provide other assistance as the licensing board may request. 
Licensing board requests for NRC staff assistance should be framed such 
that the NRC staff does not assume a role as an adversary party in the 
informal hearing (see Section C.8 below),
    (vii) Review all requests for additional hearing procedures and 
refer all appropriate requests to the Commission with a decision 
explaining the licensing board's action,
    (viii) Certify the hearing record to the Commission, based upon the 
licensing board's determination that the hearing record contains 
sufficient information for the Commission to make a reasoned 
determination on the controverted matter; and
    (ix) Include with its certification any concerns identified by the 
licensing board in the course of the hearing which, although neither 
raised by the parties nor necessary to resolution of the controverted 
hearing matters, are significant enough in the licensing board's view 
to warrant attention by the Commission.
    Licensing board determinations with respect to referral of requests 
to the Commission, as well as licensing board determinations of 
parties' motions, are not appealable to the Commission as an 
interlocutory matter. Instead, any disagreements with the licensing 
board's determinations and a specific discussion of how the hearing 
record is deficient with respect to the contested issue must be set 
forth in the parties' proposed findings of fact which are submitted 
directly to the Commission (see Section C.13 below).
    As suggested by Item (10) above, the licensing board shall not have 
any ``sua sponte'' authority analogous to 10 CFR 2.760a. The Commission 
believes that in the absence of a request for an informal hearing on a 
matter, the Commission should resolve issues with respect to the design 
certification rule in the same manner as other agency-identified 
rulemaking issues, viz., through NRC staff consideration of the issue 
followed by the Commission's review and its final resolution of the 
matter. However, when it certifies the completed hearing record to the 
Commission (see Section C.12. below), the licensing board should 
identify to the Commission any concerns identified during the hearing 
that are significant enough to warrant Commission consideration but 
that are unnecessary or irrelevant to the resolution of the 
controverted hearing matter.
    The licensing board shall close the hearing and certify the record 
to the Commission only after it determines that the record on the 
controverted matter is sufficiently complete for the Commission to make 
a reasoned determination with respect to that matter. However, the 
licensing board shall not have any responsibility or authority to 
resolve and decide controverted matters in either an informal or a 
formal hearing. Rather, the Commission retains its traditional 
authority in rulemaking proceedings to evaluate and resolve all 
rulemaking issues identified in public comments on a proposed rule. 
Therefore, the Commission will resolve any controverted matters that 
are the subject of a hearing in this design certification rulemaking.
7. Consolidation of Parties and Issues; Joint Hearings on Related 
Issues
    If two or more persons seek an informal hearing on the same or 
similar matters, the Commission may, in its discretion, grant an 
informal hearing and consolidate the matters into a single issue (as 
defined by the Commission). The Commission may also, in its discretion, 
require that the parties be consolidated analogous to the consolidation 
permitted under 10 CFR 2.715a. If the Commission consolidates two or 
more issues into a single consolidated issue but does not consolidate 
parties, each admitted person will be deemed a separate party with an 
individual right to:
    (i) Submit separate written presentations,
    (ii) Submit separate sets of proposed oral questions to be asked by 
the licensing board (see Section C.10 below),
    (iii) Make separate oral presentation, and
    (iv) Submit and separately respond to motions. If the Commission 
also requires that parties be consolidated, the consolidated parties 
must participate jointly, including deciding upon written and oral 
presentations, submitting a single set of written questions, submitting 
motions supported by each of the consolidated parties, and 
[[Page 17941]] responding to motions filed by other parties.
    During the informal hearing, the licensing board may decide that 
further consolidation of issues or parties would simplify the overall 
conduct of informal hearings or materially reduce the time or resources 
devoted to the hearings. In these instances, the licensing board may 
direct such consolidation. The licensing board shall set forth the 
issues and/or parties to be consolidated and the reasons for such 
consolidation in a written order.
8. Status of the Design Certification Applicant, the NRC staff, and 
Requesting Party
    The design certification applicant shall be a party in the informal 
hearing, with the right to submit written and oral presentations, 
propose questions to be asked by the licensing board of oral 
presenters, and file and submit appropriate motions.
    The NRC staff shall not be a party in the informal hearing but 
shall be available in the informal hearing to answer licensing board 
questions about the FSER or the proposed rule, provide additional 
information or documentation with respect to the design certification, 
and provide other assistance that the licensing board may request 
without the NRC staff assuming the role of a party in the informal 
hearing.
    A party whose hearing requests have been granted with respect to a 
particular controverted matter shall not participate with respect to 
any controverted matter on which the party was not granted a hearing. 
For example, if Person 1 has been authorized as a party on Issue A and 
Person 2 has been authorized as a party on Issue B, then Person 1 may 
participate only in the informal hearing on Issue A, and may not 
participate in the informal hearing on Issue B. Conversely, Person 2 
may participate only in the informal hearing on Issue B, and may not 
participate in the informal hearing on Issue A.
9. Requests for Discovery
    Any party may request the opportunity to conduct discovery against 
another party before the oral phase of the informal hearing. The 
request for discovery must:
    (i) Identify the type of discovery permitted under 10 CFR 2.740, 
2.740a, 2.740a(b), 2.741, and 2.742 which the party seeks to use;
    (ii) Identify the subject matter or nature of the information 
sought to be obtained by discovery; and
    (iii) Explain with particularity the relevance of the information 
sought to the controverted matter which is the subject of the hearing 
and why this information is indispensable to the presentation of the 
party's position on the controverted matter.
    The request shall be filed with the licensing board, with copies of 
the request to be filed with the party against which discovery is 
sought, and the NRC staff. The requests must be received no later than 
the deadline specified by the Commission in its decision granting a 
party's hearing request (see Section C.5. above). A party against whom 
discovery is sought may file a response objecting to part or all of the 
request. Such a response must explain with particularity why the 
discovery request should not be granted.
    The licensing board shall review all discovery requests and refer 
to the Commission those requests that it believes should be granted 
within 7 days after the date for receiving a party's objections to a 
discovery request. The licensing board shall issue a written decision 
explaining its basis for either referring the request to the Commission 
or declining to refer it. The written decision shall accompany the 
discovery requests which are referred by the licensing board to the 
Commission.
    The Commission will determine whether to grant any discovery 
requests forwarded to it based upon the licensing board's decision, 
together with the request and the design certification applicant's 
response (and any NRC staff response requested by the licensing board). 
Discovery will be at the discretion of the Commission. In this regard, 
the Commission notes that 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 applicant, and summaries of meetings held between 
the NRC staff and the design certification applicant. The NRC staff's 
bases for approving the System 80+ design are set forth in the FSER 
(NUREG-1462), dated August 1994. The Commission also notes that each 
admitted party has already disclosed a substantial amount of 
information in its hearing request, relating both to bases for the 
party's position with respect to the controverted matter as well as 
information on the qualifications of the party (or its representatives 
and witnesses in the hearing).
    As discussed above, much of the information documenting the NRC 
staff's review and approval of the design certification application has 
been routinely placed in the docket file. Furthermore, as discussed 
above in Section C.8., the NRC staff is not a party in an informal 
hearing. Therefore, the Commission has decided that in an informal 
hearing, the parties should not be afforded discovery against the NRC 
staff.
10. Conduct of Informal Hearing
    If the Commission authorizes discovery, the licensing board shall 
establish a schedule for the conduct and completion of discovery. 
Normally, the licensing board should not permit more than one round of 
discovery. The Commission will not entertain any interlocutory appeals 
from licensing board orders resolving any discovery disputes or 
otherwise complaining of the scheduling of discovery.
    Following the completion of discovery, the licensing board should 
issue an order setting forth the date of commencement of the oral phase 
of each informal hearing, and the date (no less than 30 days before the 
commencement of the oral phase of the hearing) by which parties must 
submit:
    (i) The identities and curriculum vitae of those persons providing 
oral presentations;
    (ii) The outlines of the oral presentations; and
    (iii) Any questions which a party would like the licensing board to 
ask.
    The licensing board may schedule the oral phases of two or more 
informal hearings to be held during the same session. The licensing 
board shall publish a notice in the Federal Register announcing the 
commencement of the oral phase of the informal hearing(s). The notice 
shall set forth the place and time of the oral hearing session, the 
subject matter(s) of the informal hearing(s), a brief description of 
the informal hearing procedures, and a statement indicating that the 
public may observe the informal hearing.
    Based upon the parties' outlines of the oral presentations and 
proposed questions, the licensing board should determine whether it has 
specific questions of the NRC staff with respect to the staff's review 
of the design [[Page 17942]] certification application. These questions 
should be submitted in writing to the NRC staff no less than 20 days 
before the commencement of the oral phase of the hearing and must 
specify the date by which the NRC staff shall provide its written 
answers to the licensing board. The licensing board shall send copies 
of the request by overnight mail to all parties. The NRC staff shall 
file its written answers with the licensing board and the parties.
    During the oral phase of the hearing, the licensing board shall 
receive into evidence the written presentations of the parties and 
permit each party (or the representatives identified in their hearing 
request) to make oral presentations addressing the controverted matter. 
Normally, the party raising the controverted matter should make their 
presentations, followed by the presentations of the design 
certification applicant. The licensing board may question the persons 
making oral presentations, using its own questions as well as those 
submitted to the licensing board by the other parties. Based upon the 
parties' oral presentations and/or responses to licensing board 
questions, the licensing board may also orally question the NRC staff.
11. Additional Hearing Procedures and Formal Hearings
    After the parties have made their oral presentations and the 
licensing board has concluded its questioning of the presenters (and, 
as applicable, the NRC staff), the licensing board should declare that 
the oral phase of an informal hearing on a controverted matter (or 
consolidated set of controverted matters) is complete.
    No later than 10 days after the licensing board has declared that 
the oral phase of the informal hearing has been completed, parties may 
file with the licensing board (with copies to the applicant and the NRC 
staff) a request that some or all of the procedures described in 10 CFR 
part 2, subpart G (e.g., direct and cross-examination by the parties) 
be utilized. The request shall:
    (i) Identify the specific hearing procedures which the party seeks, 
or state that a formal hearing is requested;
    (ii) Identify the specific factual issues for which the additional 
procedures would be utilized;
    (iii) Explain why resolution of these factual disputes are 
necessary to the Commission's decision on the controverted issue;
    (iv) Explain, with specific citations to the hearing record, why 
the record is insufficient on the controverted matter; and
    (v) Identify the nature of the evidence that would be developed 
utilizing the additional procedures requested.
    The design certification applicant may file a response to these 
requests no later than 7 days after the applicant's receipt of a 
request for additional procedures. The NRC staff will not provide a 
response unless specifically requested to do so by the licensing board.
    The licensing board will review all requests for additional hearing 
procedures or a formal hearing and refer those that it believes should 
be granted to the Commission for its determination. The licensing board 
shall issue a written decision explaining its determination whether to 
forward the request to the Commission no later than 7 days after 
receipt of any applicant response to the request. The decision will 
provide the basis for either forwarding the request to the Commission 
or declining to forward it. In the absence of any requests for hearing 
procedures or if the licensing board concludes that none of the 
requests should be referred to the Commission, the licensing board 
should declare that the hearing record is closed (see Section C.12 
below).
    The Commission will determine whether to grant any requests for 
additional procedures or a formal hearing that are forwarded by the 
licensing board. The Commission's determination shall be based upon the 
licensing board's decision along with the request and the design 
certification applicant's response. If the Commission directs that a 
formal hearing be held on a controverted factual matter, the NRC staff 
shall be a party in the formal hearing. After either the additional 
hearing procedures authorized by the Commission are completed or the 
formal hearing is concluded on the factual dispute, the licensing board 
should declare the hearing record closed (see Section C.12 below).
12. Licensing Board's Certification of Hearing Record to the Commission
    After the oral phase of a hearing is completed and either:
    (i) There are no requests for additional hearing procedures or a 
formal hearing; or
    (ii) The licensing board concludes that none of the requests should 
be referred to the Commission, then the licensing board should declare 
that the hearing record is closed.
    If the Commission directs that additional hearing procedures should 
be utilized or a formal hearing be held on specific factual disputes, 
the licensing board should declare the hearing record closed after 
completion of the additional hearing procedures or the formal hearing. 
Within 30 days of the closing of the hearing record the licensing board 
should certify the hearing record to the Commission on each 
controverted matter (or consolidated set of controverted 
matters).<SUP>7

    \7\An informal hearing is deemed to be completed when the period 
for requesting additional procedures or a formal hearing expires and 
no request is received.
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    The licensing board's certification for each controverted matter 
(or consolidated set of controverted matters) shall contain:
    (i) The hearing record, including a transcript of the oral phase of 
the hearing (and any pre-hearing conferences) and copies of all filings 
by the parties and the licensing board,
    (ii) A list of all documentary evidence admitted by the licensing 
board, including the written presentations of the parties,
    (iii) Copies of the documentary evidence admitted by the licensing 
board,
    (iv) A list of all witnesses who provided oral testimony,
    (v) The NRC staff's written answers to licensing board requests, 
and
    (vi) A licensing board statement that the hearing record contains 
sufficient information for the Commission to make a reasoned 
determination on the controverted matter.
    Finally, as discussed in Section C.6 above, the licensing board 
should identify any issues not raised by the parties or otherwise are 
not relevant to the controverted matters in the hearing, that the 
licensing board believes are significant enough to warrant attention by 
the Commission.
13. Parties' Proposed Findings of Fact and Conclusions
    The applicant must file directly with the Commission proposed 
findings of fact and conclusions for each controverted hearing matter 
(or consolidated set of controverted matters) within 30 days following 
the close of the hearing record on that matter in the form of a 
proposed final rule and statement of considerations with respect to the 
controverted hearing issues.
    Other parties are encouraged, but not required, to file with the 
Commission proposed findings of fact and conclusions limited to those 
issues which a party was afforded a hearing by the Commission (i.e., a 
party may not file proposed findings of fact and conclusions on issues 
which it was not [[Page 17943]] admitted). Any findings that a party 
wishes the Commission to consider must be received by the Commission no 
later than 30 days after the licensing board closes the hearing record 
on that issue. Although parties are not required to file proposed 
findings and conclusions, a party who does not file a finding may not, 
upon appeal, claim or otherwise argue that the Commission either 
misunderstood the party's position, or failed to address a specific 
piece of evidence or issue.

D. Resolution of Issues for the Final Rulemaking

1. Absence of Qualifying Hearing Request
    If the Commission does not receive any request for hearing within 
the 120-day period for submitting a request, or does not grant any of 
the requests (see Section B. above), the Commission will determine 
whether the proposed design certification rule meets the applicable 
standards and requirements of the Atomic Energy Act of 1954, as amended 
(AEA), the National Environmental Policy Act of 1969, as amended 
(NEPA), and the Commission's rules and regulations. The Commission's 
determination will be based upon the rulemaking record, which includes: 
The application for design certification, including the SSAR and DCD; 
the applicant's responses to the NRC staff's requests for additional 
information; the NRC staff's FSER and any supplements thereto; the 
report on the application by the ACRS; the applicant's Technical 
Support Document addressing consideration of severe accident mitigation 
design alternatives (SAMDAs) for purposes of NEPA; the NRC staff's EA 
and draft FONSI; the proposed rule, and the public comments received on 
the proposed rule. If the Commission makes an affirmative finding, it 
will issue a standard design certification in the form of a rule by 
adding a new appendix to 10 CFR part 52, and publish the design 
certification rule and a statement of considerations in the Federal 
Register.
2. Commission Resolution of Issues Where a Hearing is Granted
    All matters related to the proposed design certification rule, 
including those matters for which the Commission authorizes a hearing 
(see Sections B. and C. above), will be resolved by the Commission 
after the licensing board has closed the hearing record and certified 
it to the Commission. The Commission will determine whether the 
proposed design certification rule meets the applicable standards and 
requirements of the AEA, NEPA, and the Commission's rules and 
regulations. The Commission's determination will be based upon the 
rulemaking record as described in Section D.1 above, with the addition 
of the hearing record for controverted matters. If the Commission makes 
an affirmative finding, the Commission will issue a final design 
certification rule as described in Section D.1.

E. Access to Proprietary Information in Rulemaking

1. Access to Proprietary Information for the Preparation of Written 
Comments or Informal Hearing Requests
    Persons who determine that they need to review proprietary 
information submitted by the design certification applicant to the NRC 
in order to submit written comments on the proposed certification or to 
prepare an informal hearing request, may request access to such 
information from the applicant.
    The request shall state with particularity:
    (i) The nature of the proprietary information sought,
    (ii) The reason why the nonproprietary information currently 
available to the public in the NRC's Public Document Room is 
insufficient either to develop public comments or to prepare for the 
hearing,
    (iii) The relevance of the requested information either to the 
issue which the commenter wishes to comment on, and
    (iv) A showing that the person requesting the information has the 
capability to understand and utilize the requested information.
    Requests must be filed with the applicant such that they are 
received by the applicant no later than 45 days after the date that 
this notice of proposed rulemaking is published in the Federal 
Register.
    Within ten (10) days of receiving the request, the applicant must 
send a written response to the person seeking access. The response must 
either provide the documents requested (or state that the document will 
be provided no later than ten days after the date of the response), or 
state that access has been denied. If access is denied, the response 
shall state with particularity the reasons for its refusal. The 
applicant's response must be provided via express mail.
    The person seeking access may then request a Commission hearing for 
the purpose of obtaining a Commission order directing the design 
certification applicant to disclose the requested information. The 
person must include copies of the original request (and any subsequent 
clarifying information provided by the person requesting access to the 
applicant) and the applicant's response. The Commission will base its 
decision solely on the person's original request (including any 
clarifying information provided to the applicant by the person 
requesting access), and the applicant's response. Accordingly, a person 
seeking access to proprietary information should ensure that the 
request sets forth in sufficient detail and particularity the 
information required to be included in the request. Similarly, the 
applicant should ensure that its response to any request states with 
sufficient detail and particularity the reasons for its refusal to 
provide the requested information.
    If the Commission orders access in whole or part, the Commission 
will specify the date by which the requesting party must file with the 
Commission written comments and any request for an informal hearing 
before a licensing board as discussed in Section V.C. above. A request 
for an informal hearing must meet the requirements set forth above in 
Section V.C., in particular the requirements governing the content of 
the hearing request, and shall be governed by the procedures and 
standards governing such requests set forth in Section V.C.
2. Access to Proprietary Information in a Hearing
    Parties who are granted a hearing may request access to proprietary 
information. Parties must first request access to proprietary 
information regarding the proposed design certification from the 
applicant. The request shall state with particularity:
    (i) The nature of the proprietary information sought,
    (ii) The reason why the nonproprietary information currently 
available to the public in the NRC's Public Document Room is 
insufficient to prepare for the hearing,
    (iii) The relevance of the requested information to the hearing 
issue(s) for which the party has been admitted, and
    (iv) A showing that the requesting party has the capability to 
understand and utilize the requested information. The request must be 
filed with the applicant no later than the date established by the 
Commission for filing discovery requests with the licensing board.
    If the applicant declines to provide the information sought, within 
10 days of receiving the request the applicant must send a written 
response to the requesting party setting forth with particularity the 
reasons for its refusal. [[Page 17944]] The party may then request the 
licensing board to order disclosure. The party must include copies of 
the original request (and any subsequent clarifying information 
provided by the requesting party to the applicant) and the applicant's 
response. The licensing board shall base its decision solely on the 
party's original request (including any clarifying information provided 
by the requesting party to the applicant), and the applicant's 
response.
    Accordingly, a party requesting proprietary information from the 
applicant should ensure that its request sets forth in sufficient 
detail and particularity the information required to be included in the 
request. Similarly, the applicant should ensure that its response to 
any request states with sufficient detail and particularity the reasons 
for its refusal to provide the requested information. The licensing 
board may order the Applicant to provide access to some or all of the 
requested information, subject to an appropriate non-disclosure 
agreement.

F. Ex Parte and Separation of Functions Restrictions

    Unless the formal procedures of 10 CFR part 2, subpart G are 
approved for a formal hearing in the design certification rulemaking 
proceeding, the NRC staff will not be a party in the hearing and 
separation of functions limitations will not apply. The NRC staff may 
assist in the hearing by answering questions about the FSER put to it 
by the licensing board, or to provide additional information, 
documentation, or other assistance as the licensing board may request. 
Furthermore, other than in a formal hearing, the NRC staff shall not be 
subject to discovery by any party, whether by way of interrogatory, 
deposition, or request for production of documents.
    Second, the Commission has determined that once a request for an 
informal or formal hearing is received, certain elements of the ex 
parte restrictions in 10 CFR 2.780(a) will be applicable with respect 
to the subject matter of that hearing request. Under these 
restrictions, the Commission will communicate with interested persons/
parties, the NRC staff, and the licensing board with respect to the 
issues covered by the hearing request only through docketed, publicly-
available written communications and public meetings. Individual 
Commissioners may communicate privately with interested persons and the 
NRC staff; however, the substance of the communication shall be 
memorialized in a document which will be placed in the PDR and 
distributed to the licensing board and relevant parties.

VI. Finding of No Significant Environmental Impact: Availability

    The Commission has determined under NEPA and the Commission's 
regulations in 10 CFR part 51, subpart A, that this proposed design 
certification rule, if adopted, would not be a major Federal action 
significantly affecting the quality of the human environment, and 
therefore an environmental impact statement (EIS) is not required. The 
basis for this determination, as documented in the environmental 
assessment, is that the amendment to 10 CFR Part 52 would not authorize 
the siting, construction, or operation of a facility using the System 
80+ design; it would only codify the System 80+ design in a rule. The 
NRC will evaluate the environmental impacts and issue an EIS as 
appropriate in accordance with NEPA as part of the application(s) for 
the construction and operation of a facility.
    In addition, as part of the environmental assessment for the System 
80+ design, the NRC reviewed pursuant to NEPA, ABB-CE's evaluation of 
various design alternatives to prevent and mitigate severe accidents 
that was submitted in ABB-CE's ``Technical Support Document for the 
System 80+.'' The Commission finds that ABB-CE's evaluation provides a 
sufficient basis to conclude that there is reasonable assurance that an 
amendment to 10 CFR part 52 certifying the System 80+ design will not 
exclude a severe accident design alternative for a facility referencing 
the certified design that would have been cost beneficial had it been 
considered as part of the original design certification application. 
These issues are considered resolved for the System 80+ design.
    The environmental assessment, upon which the Commission's finding 
of no significant impact is based, and the Technical Support Document 
for the System 80+ are available for examination and copying at the NRC 
Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. 
Single copies are also available from Mr. Harry Tovmassian, Mailstop T-
9 F33, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555, (301) 415-6231.

VII. Paperwork Reduction Act Statement

    This proposed rule amends information collection requirements that 
are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et 
seq.). This rule has been submitted to the Office of Management and 
Budget for review and approval of the paperwork requirements. The 
public reporting burden for this collection of information is zero 
hours. Send comments regarding this burden estimate or any other aspect 
of this collection of information, including suggestions for reducing 
this burden, to the Information and Records Management Branch (T 6-
F33), U.S. Nuclear Regulatory Commission, Washington, DC. 20555-0001; 
and to the Desk Officer, Office of Information and Regulatory Affairs, 
NEOB-10202, (3150-0151), Office of Management and Budget, Washington, 
DC 20503.

VIII. Regulatory Analysis

    The NRC has not prepared a regulatory analysis for this proposed 
rule. The NRC prepares regulatory analyses for rulemakings that 
establish generic regulatory requirements. Design certifications are 
not generic rulemakings. Rather, design certifications are Commission 
approvals of specific nuclear power plant designs by rulemaking. 
Furthermore, design certification rulemakings are initiated by an 
applicant for a design certification, rather than the NRC. Preparation 
of a regulatory analysis in this circumstance would not be useful 
because the design to be certified is proposed by the applicant rather 
than the NRC. For these reasons, the Commission concludes that 
preparation of a regulatory analysis is neither required nor 
appropriate.

IX. Regulatory Flexibility Act Certification

    In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the Commission certifies that this proposed rulemaking will not 
have a significant economic impact upon a substantial number of small 
entities. The proposed rule provides standard design certification for 
a light water nuclear power plant design. Neither the design 
certification applicant, nor nuclear power plant licensees who 
reference this design certification rule, fall within the scope of the 
definition of ``small entities'' set forth in the Regulatory 
Flexibility Act, 15 U.S.C. 632, or the Small Business Size Standards 
set out in regulations issued by the Small Business Administration in 
13 CFR part 121. Thus, this rule does not fall within the purview of 
the act.

X. Backfit Analysis

    The Commission has determined that the backfit rule, 10 CFR 50.109, 
does not apply to this proposed rule because these amendments do not 
impose requirements on existing 10 CFR part 50 
[[Page 17945]] licensees. Therefore, a backfit analysis was not 
prepared for this rule.

List of Subjects in 10 CFR Part 52

    Administrative practice and procedure, Antitrust, Backfitting, 
Combined license, Early site permit, Emergency planning, Fees, 
Incorporation by reference, Inspection, Limited work authorization, 
Nuclear power plants and reactors, Probabilistic risk assessment, 
Prototype, Reactor siting criteria, Redress of site, Reporting and 
recordkeeping requirements, Standard design, Standard design 
certification.
    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 553; the NRC proposes to adopt 
the following amendment to 10 CFR part 52.
    1. The authority citation for 10 CFR part 52 continues to read as 
follows:

    Authority: Secs. 103, 104, 161, 182, 183, 186, 189, 68 Stat. 
936, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 1244, 
as amended (42 U.S.C. 2133, 2201, 2232, 2233, 2236, 2239, 2282); 
secs. 201, 202, 206, 88 Stat. 1243, 1244, 1246, 1246, as amended (42 
U.S.C. 5841, 5842, 5846).

    2. In Sec. 52.8, paragraph (b) is revised to read as follows:


Sec. 52.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Secs. 52.15, 52.17, 52.29, 52.45, 52.47, 52.57, 
52.75, 52.77, 52.78, 52.79, appendix A, and appendix B.
    3. A new appendix B to 10 CFR part 52 is added to read as follows:

Appendix B to Part 52--Design Certification Rule for the System 80+ 
Standard Plant

    1. Scope.
    This Appendix constitutes the standard design certification for 
the System 80+<SUP>1 design, in accordance with 10 CFR part 52, 
subpart B. The applicant for certification of the System 80+ design 
was Combustion Engineering, Inc. (ABB-CE).

    \1\''System 80+'' is a trademark of Combustion Engineering, Inc.
---------------------------------------------------------------------------

    2. Definitions.
    As used in this part:
    (a) Design control document (DCD) means the master document that 
contains the Tier 1 and Tier 2 information that is incorporated by 
reference into this design certification rule.
    (b) Tier 1 means the portion of the design-related information 
contained in the DCD that is certified by this design certification 
rule (hereinafter Tier 1 information). Tier 1 information consists 
of:
    (1) Definitions and general provisions,
    (2) Certified design descriptions,
    (3) Inspections, tests, analyses, and acceptance criteria 
(ITAAC),
    (4) Significant site parameters, and
    (5) Significant interface requirements.

The certified design descriptions, interface requirements, and site 
parameters are derived from Tier 2 information.
    (c) Tier 2 means the portion of the design-related information 
contained in the DCD that is approved by this design certification 
rule (hereinafter Tier 2 information). Tier 2 information includes:
    (1) The information required by 10 CFR 52.47,
    (2) The information required for a final safety analysis report 
under 10 CFR 50.34(b), and
    (3) Supporting information on the inspections, tests, and 
analyses that will be performed to demonstrate that the acceptance 
criteria in the ITAAC have been met.
    (d) Tier 2* means the portion of the Tier 2 information which 
cannot be changed without prior NRC approval. This information is 
identified in the DCD.
    (e) All other terms in this rule have the meaning set out in 10 
CFR 50.2, 10 CFR 52.3, or Section 11 of the Atomic Energy Act of 
1954, as amended, as applicable.
    3. [Reserved].
    4. Contents of the design certification.
    (a) Both Tier 1 and Tier 2 of the System 80+ Design Control 
Document, ABB-CE, Revision 1, February 1995 are incorporated by 
reference. This incorporation by reference was approved by the 
Director of the Office of the Federal Register on [Insert date of 
approval] in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies of the System 80+ DCD may be obtained from [Insert name and 
address of applicant or organization designated by the applicant]. 
Copies are also available for examination and copying at the NRC 
Public Document Room, 2120 L Street NW, Washington, DC 20555, and 
for examination at the NRC Library, 11545 Rockville Pike, Rockville, 
Maryland 20582-2738.
    (b) An applicant for a construction permit, operating license, 
or combined license that references this design certification must 
reference both Tier 1 and Tier 2 of the System 80+ DCD.
    (c) If there is a conflict between the System 80+ DCD and either 
the application for design certification for the System 80+ design 
or NUREG-1462 ``Final Safety Evaluation Report related to the 
Certification of the System 80+ Design,'' dated August 1994 (FSER), 
then the System 80+ DCD is the controlling document.
    5. Exemptions and applicable regulations.
    (a) The System 80+ design is exempt from portions of the 
following regulations, as described in the FSER (index provided in 
Section 1.6 of the FSER):
    (1) Section VI(a)(2) of appendix A to 10 CFR part 100--Operating 
Basis Earthquake Design Consideration;
    (2) Section (b)(3) of 10 CFR 50.49--Environmental Qualification 
of Post-Accident Monitoring Equipment;
    (3) Section (f)(2)(iv) of 10 CFR 50.34--Separate Plant Safety 
Parameter Display Console;
    (4) Section (f)(2)(viii) of 10 CFR 50.34--Post-Accident Sampling 
for Hydrogen, Boron, Chloride, and Dissolved Gases;
    (5) Section (f)(3)(iv) of 10 CFR 50.34--Dedicated Containment 
Penetration;
    (6) Section III.A.1.(a) of appendix J to 10 CFR part 50--
Containment Leakage Testing; and
    (7) Sections (f)(2) (vii), (viii), (xxvi), and (xxviii) of 10 
CFR 50.34--Accident Source Terms.
    (b) Except as indicated in paragraph (c) of this section, the 
regulations that apply to the System 80+ design are those 
regulations in 10 CFR Parts 20, 50, 73, and 100 (August 1994), that 
are applicable and technically relevant, as described in the FSER.
    (c) In addition to the regulations specified in paragraph (b) of 
this section, the following regulations are applicable for purposes 
of 10 CFR 52.48, 52.54, 52.59 and 52.63:
    (1) In the standard design, the effects of intersystem loss-of-
coolant accidents must be minimized by designing low-pressure piping 
systems that interface with the reactor coolant pressure boundary to 
withstand full reactor coolant system pressure to the extent 
practical.
    (2)(i) Piping systems associated with pumps and valves subject 
to the test requirements set forth in 10 CFR 50.55a(f) must be 
designed to allow for:
    (A) Full flow testing of pumps and check valves at maximum 
design flow, and
    (B) Testing of motor operated valves under maximum achievable 
differential pressure, up to design basis differential pressure, to 
demonstrate the capability of the valves to operate under design 
basis conditions.
    (ii) For pumps and valves subject to the test requirements set 
forth in 10 CFR 50.55a(f), an applicant for a combined license which 
references this standard design certification rule shall submit, as 
part of the application:
    (A) A program for testing check valves that incorporates the use 
of advanced non-intrusive techniques to detect degradation and 
monitor performance characteristics, and
    (B) A program to determine the frequency necessary for 
disassembly and inspection of each pump and valve to detect 
degradation that would prevent the component from performing its 
safety function and which cannot be detected through the use of 
advanced non-intrusive techniques. The licensee shall implement 
these programs throughout the service life of the plant.
    (3) For digital instrumentation and control systems, the design 
must include:
    (i) An assessment of the defense-in-depth and diversity of 
instrumentation and control systems;
    (ii) A demonstration of adequate defense against common-mode 
failures; and
    (iii) Provisions for independent backup manual controls and 
displays for critical safety functions in the control room.
    (4) The electric power system of the standard design must 
include an alternate power source that has sufficient capacity and 
capability to power the necessary complement of non-safety equipment 
that would most facilitate the ability of the operator to bring the 
plant to safe shutdown, following a loss of the normal power supply 
and reactor trip. [[Page 17946]] 
    (5) The electric power system of the standard design must 
include at least one offsite circuit supplied directly from one of 
the offsite power sources to each redundant safety division with no 
intervening non-safety buses in such a manner that the offsite 
source can power the safety buses upon a failure of any non-safety 
bus.
    (6)(i) The requirements of 10 CFR 50.48(a)\2\ and 10 CFR part 
50, appendix R, Section III G.1.a, apply to all structures, systems, 
and components important to safety.

    \2\For the standard design, the footnote reference in 10 CFR 
50.48(a) to Branch Technical Position Auxiliary Power Conversion 
System Branch BTP APCSB9.5-1, ``Guidelines for Fire Protection for 
Nuclear Power Plants,'' will be to the July, 1981 version.
---------------------------------------------------------------------------

    (ii) Notwithstanding any provision in paragraph (i) of this 
section, all structures, systems, and components important to safety 
in the standard design must be designed to ensure that:
    (A) Safe shutdown can be achieved assuming that all equipment in 
any one fire area will be rendered inoperable by fire and re-entry 
into that fire area for repairs and operator actions is not 
possible, except that this provision does not apply to (1) the main 
control room, provided that an alternative shutdown capability 
exists and is physically and electrically independent of the main 
control room, and (2) the reactor containment;
    (B) Smoke, hot gases, or fire suppressant will not migrate from 
one fire area into another to an extent that could adversely affect 
safe-shutdown capabilities, including operator actions; and
    (C) In the reactor containment, redundant shutdown systems are 
provided with fire protection capabilities and means to limit fire 
damage such that, to the extent practicable, one shutdown division 
remains free of fire damage.
    (7) The standard design must include and an applicant for a 
combined license which references this standard design certification 
rule shall submit as part of the application:
    (i) The description of the reliability assurance program used 
during the design that includes scope, purpose, and objectives;
    (ii) The process used to evaluate and prioritize the structures, 
systems, and components in the design, based on their degree of 
risk-significance;
    (iii) A list of structures, systems, and components designated 
as risk-significant; and
    (iv) For those structures, systems, and components designated as 
risk-significant:
    (A) A process to determine dominant failure modes that 
considered industry experience, analytical models, and applicable 
requirements; and
    (B) Key assumptions and risk insights from probabilistic, 
deterministic, and other methods that considered operation, 
maintenance, and monitoring activities.
    (8) The probabilistic risk assessment required by 10 CFR 
52.47(a)(1)(v) must include an assessment of internal and external 
events. For external events, simplified probabilistic methods and 
margins methods may be used to assess the capacity of the standard 
design to withstand the effects of events such as fires and 
earthquakes. Traditional probabilistic techniques should be used to 
evaluate internal floods. For earthquakes, a seismic margin analysis 
must consider the effects of earthquakes with accelerations 
approximately one and two-thirds the acceleration of the safe-
shutdown earthquake.
    (9) The standard design must include an on-site alternate ac 
power source of diverse design capable of powering at least one 
complete set of equipment necessary to achieve and maintain safe-
shutdown for the purposes of dealing with station blackout.
    (10)(i) The standard design must include the features in 
paragraphs (A)-(C) below that reduce the potential for and effect of 
interactions of molten core debris with containment structures:
    (A) Reactor cavity floor space to enhance debris spreading;
    (B) A means to flood the reactor cavity to assist in the cooling 
process; and
    (C) Concrete to protect portions of the containment liner and 
other structural members.
    (ii) The features required by paragraph (i) of this section, in 
combination with other features, must ensure for the most 
significant severe accident sequences that the best-estimate 
environmental conditions (pressure and temperature) resulting from 
core-concrete interaction do not exceed ASME Code Service Level C 
for steel containments or Factored Load Category for concrete 
containments for approximately 24 hours.
    (11) The standard design must include: (i) A reliable means to 
depressurize the reactor coolant system and (ii) cavity design 
features to reduce the amount of ejected core debris that may reach 
the upper containment.
    (12) The standard design must include analyses based on best-
available methods to demonstrate that:
    (i) Equipment, both electrical and mechanical, needed to prevent 
and mitigate the consequences of severe accidents is capable of 
performing its function for the time period needed in the best-
estimate environmental conditions of the severe accident (e.g., 
pressure, temperature, radiation) in which the equipment is relied 
upon to function; and
    (ii) Instrumentation needed to monitor plant conditions during a 
severe accident is capable of performing its function for the time 
period needed in the best-estimate environmental conditions of the 
severe accident (e.g., pressure, temperature, radiation) in which 
the instrumentation is relied upon to function.
    (13) The standard design must include features to limit the 
conditional containment failure probability for the more likely 
severe accident challenges.
    (14)(i) The standard design must include a systematic 
examination of features in relation to shutdown risk assessing:
    (A) Specific design features that minimize shutdown risk;
    (B) The reliability of decay heat removal systems;
    (C) Vulnerabilities introduced by new design features; and
    (D) Fires and floods occurring with the plant in modes other 
than full power.
    (ii) An applicant for a combined license which references this 
design certification rule shall submit as part of the application a 
description of the program for outage planning and control that 
ensures:
    (A) The availability and functional capability during shutdown 
and low power operations of features important to safety during such 
operations; and
    (B) The consideration of fire, flood, and other hazards during 
shutdown and low power operations. The licensee shall implement this 
program throughout the service life of the plant.
    (15) The standard design must include a best-estimate, 
systematic evaluation of the plant response to a steam generator 
tube rupture (SGTR) to:
    (i) Identify potential design vulnerabilities, and
    (ii) Assess potential design improvements to mitigate the amount 
of containment bypass leakage that could result from a SGTR.
    6. Issue resolution for the design certification.
    (a) All nuclear safety issues associated with the information in 
the FSER or DCD are resolved within the meaning of 10 CFR 
52.63(a)(4).
    (b) All environmental issues associated with the information in 
the NRC's Environmental Assessment for the System 80+ design or the 
severe accident design alternatives in Revision 2 of the Technical 
Support Document for the System 80+ dated January 1995 are resolved 
within the meaning of 10 CFR 52.63(a)(4).
    7. Duration of the design certification.
    This design certification may be referenced for a period of 15 
years from [insert date 30 days after publication in the Federal 
Register], except as provided for in 10 CFR 52.55(b) and 52.57(b). 
This design certification remains valid for an applicant or licensee 
that references this certification until their application is 
withdrawn or their license expires, including any period of extended 
operation under a renewed license.
    8. Change process.
    (a) Tier 1 information.
    (1) Generic (rulemaking) changes to Tier 1 information are 
governed by the requirements in 10 CFR 52.63(a)(1).
    (2) Generic changes to Tier 1 information are applicable to all 
plants referencing the design certification as set forth in 10 CFR 
52.63(a)(2).
    (3) Changes from Tier 1 information that are imposed by the 
Commission through plant-specific orders are governed by the 
requirements in 10 CFR 52.63(a)(3).
    (4) Exemptions from Tier 1 information are governed by the 
requirements in 10 CFR 52.63(b)(1).
    (b) Tier 2 information.
    (1) Generic changes to Tier 2 information are governed by the 
requirements in 10 CFR 52.63(a)(1).
    (2) Generic changes to Tier 2 information are applicable to all 
plants referencing the design certification as set forth in 10 CFR 
52.63(a)(2).
    (3) The Commission may not impose new requirements by plant-
specific order on Tier 2 information of a specific plant referencing 
the design certification while the design 
[[Page 17947]] certification is in effect under Secs. 52.55 or 
52.61, unless:
    (i) A modification is necessary to secure compliance with the 
Commission's regulations applicable and in effect at the time the 
certification was issued, or to assure adequate protection of the 
public health and safety or the common defense and security; and
    (ii) Special circumstances as defined in 10 CFR 50.12(a) are 
present.
    (4) An applicant or licensee who references the design 
certification may request an exemption from Tier 2 information. The 
Commission may grant such a request only if it determines that the 
exemption will comply with the requirements of 10 CFR 50.12(a). The 
granting of an exemption on request of an applicant must be subject 
to litigation in the same manner as other issues in the construction 
permit, operating license, or combined license hearing.
    (5)(i) An applicant or licensee who references the design 
certification may depart from Tier 2 information, without prior NRC 
approval, unless the proposed change involves a change to Tier 1 or 
Tier 2* information, as identified in the DCD, the technical 
specifications, or an unreviewed safety question as defined in 
paragraphs (b)(5)(ii) or (b)(5)(iii) of this section. When 
evaluating the proposed change, an applicant or licensee shall 
consider all matters described in the DCD, including generic issues 
and shutdown risk for all postulated accidents including severe 
accidents. These changes will no longer be considered ``matters 
resolved in connection with the issuance or renewal of a design 
certification'' within the meaning of 10 CFR 52.63(a)(4).
    (ii) A proposed departure from Tier 2 information, other than 
severe accident issues identified in Section 19.11 of the DCD, 
including appendices 19.11A through 19.11L, must be deemed to 
involve an unreviewed safety question if:
    (A) The probability of occurrence or the consequences of an 
accident or malfunction of equipment important to safety previously 
evaluated in the DCD may be increased;
    (B) A possibility for an accident or malfunction of a different 
type than any evaluated previously in the DCD may be created; or
    (C) The margin of safety as defined in the basis for any 
technical specification is reduced.
    (iii) A proposed departure from information associated with 
severe accident issues identified in Section 19.11 of the DCD, 
including appendices 19.11A through 19.11L, must be deemed to 
involve an unreviewed safety question if:
    (A) There is a substantial increase in the probability of a 
severe accident such that a particular severe accident previously 
reviewed and determined to be not credible could become credible; or
    (B) There is a substantial increase in the consequences to the 
public of a particular severe accident previously reviewed.
    (iv) Departures from Tier 2 information made in accordance with 
Section 8(b)(5) above do not require an exemption from this design 
certification rule.
    (c) Other requirements of this design certification rule.
    An applicant or licensee who references the design certification 
may not depart from this rule's requirements, other than Tier 1 or 2 
information, other than by an exemption in accordance with 10 CFR 
50.12.
    9. Records and Reports.
    (a) Records.
    (1) The applicant for this design certification shall maintain a 
copy of the DCD that includes all generic changes to Tier 1 and Tier 
2 information.
    (2) An applicant or licensee that references this design 
certification shall maintain records of all changes to and 
departures from the DCD pursuant to Section 8 of this appendix. 
Records of changes made pursuant to Section 8(b)(5) must include a 
written safety evaluation which provides the bases for the 
determination that the proposed change does not involve an 
unreviewed safety question, a change to Tier 1 or Tier 2* 
information, or a change to the technical specifications.
    (b) Reports. An applicant or licensee that references this 
design certification shall submit a report to the NRC, as specified 
in 10 CFR 50.4, containing a brief description of any departures 
from the DCD, including a summary of the safety evaluation of each. 
An applicant or licensee shall also submit updates to the DCD to 
ensure that the DCD contains the latest material developed for both 
Tier 1 and 2 information. The requirements of 10 CFR 50.71 for 
safety analysis reports must apply to these updates. These reports 
and updates must be submitted at the frequency specified below:
    (1) During the interval from the date of application to the date 
of issuance of either a construction permit under 10 CFR part 50 or 
a combined license under 10 CFR part 52, the report and any updates 
to the DCD may be submitted along with amendments to the 
application.
    (2) During the interval from the date of issuance of either a 
construction permit under 10 CFR part 50 or a combined license under 
10 CFR part 52 until the applicant or licensee receives either an 
operating license under 10 CFR part 50 or the Commission makes its 
findings under 10 CFR 52.103, the report must be submitted 
quarterly. Updates to the DCD must be submitted annually.
    (3) Thereafter, reports and updates to the DCD may be submitted 
annually or along with updates to the safety analysis report for the 
facility as required by 10 CFR 50.71, or at such shorter intervals 
as may be specified in the license.
    (c) Retention period. The DCD and the records of changes to and 
departures from the DCD must be maintained until the date of 
termination of the construction permit or license.

    Dated at Rockville, MD, this 31st day of March, 1995.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 95-8380 Filed 4-6-95; 8:45 am]
BILLING CODE 7590-01-P

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