[Federal Register Volume 62, Number 98 (Wednesday, May 21, 1997)]
[Rules and Regulations]
[Pages 27840-27870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12742]



[[Page 27839]]

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Part II





Nuclear Regulatory Commission





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10 CFR Part 52



Standard Design Certification for the System 80+ Design; Final Rule

  Federal Register / Vol. 62, No. 98 / Wednesday, May 21, 1997 / Rules 
and Regulations  

[[Page 27840]]


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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: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC or Commission) is 
amending its regulations to certify the System 80+ design. The NRC is 
adding a new provision to its regulations that approves the System 80+ 
design by rulemaking. This action is necessary so that applicants for a 
combined license that intend to construct and operate the System 80+ 
design may do so by appropriately referencing this regulation. The 
applicant for certification of the System 80+ design was Combustion 
Engineering, Inc. (ABB-CE).

EFFECTIVE DATE: The effective date of this rule is June 20, 1997. The 
incorporation by reference of certain publications listed in the 
regulations is approved by the Director of the Federal Register as of 
June 20, 1997.

FOR FURTHER INFORMATION CONTACT: 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 20555-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background.
II. Public comment summary and resolution.
    A. Principal Issues.
    1. Finality.
    2. Tier 2 Change Process.
    3. Need for Additional Applicable Regulations.
    B. Responses to specific requests for comment from proposed 
rule.
    C. Other Issues.
    1. NRC Verification of ITAAC Determinations.
    2. DCD Introduction.
    3. Duplicate documentation in design certification rule.
III. Section-by-section discussion.
    A. Introduction (Section I).
    B. Definitions (Section II).
    C. Scope and contents (Section III).
    D. Additional requirements and restrictions (Section IV).
    E. Applicable regulations (Section V).
    F. Issue resolution (Section VI).
    G. Duration of this appendix (Section VII).
    H. Processes for changes and departures (Section VIII).
    I. Inspections, tests, analyses, and acceptance criteria 
(Section IX).
    J. Records and Reporting (Section X).
IV. Finding of no significant environmental impact: availability.
V. Paperwork Reduction Act statement.
VI. Regulatory analysis.
VII. Regulatory Flexibility Act certification.
VIII. Backfit analysis.

I. Background

    On March 30, 1989, Combustion Engineering, Inc. 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.
    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, Combustion Engineering, Inc. 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 Subpart B of 10 CFR part 52. 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. 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. Therefore, 
ABB-CE will be used for Combustion Engineering, Inc. throughout this 
statement of consideration.
    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. Subsequently, the 
applicant submitted changes to the System 80+ design and the NRC staff 
evaluated these design changes in a supplement to the FSER (NUREG-1462, 
Supplement No. 1). A copy of the FSER and Supplement No. 1 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. A final design 
approval (FDA) was issued for the System 80+ design on July 26, 1994 
and revised on November 23, 1994 to provide a 15 year duration. An FDA, 
which incorporates the design changes, will be issued to supersede the 
current FDA after issuance of this final design certification rule.
    The NRC staff originally proposed a conceptual design certification 
rule for evolutionary standard plant designs in SECY-92-287, ``Form and 
Content for a Design Certification Rule.'' Subsequently, the NRC staff 
modified the draft rule language proposed 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. In 
accordance with the Administrative Procedure Act of 1947 (APA), as 
amended, 10 CFR part 52 provides the opportunity for the public to 
submit written comments on proposed design certification rules. 
However, Part 52 went beyond the requirements of the APA by providing 
the public with an opportunity to request a hearing before an Atomic 
Safety and Licensing Board in a design certification rulemaking. 
Therefore, on April 7, 1995 (60 FR 17924), the NRC published a proposed 
rule in the Federal Register which invited public comment and provided 
the public with the opportunity to request an informal hearing before 
an Atomic Safety and Licensing Board. The period within which an 
informal hearing could be requested expired on August 7, 1995. The NRC 
did not receive any requests for an informal hearing during this 
period. The NRC staff conducted public meetings on the development of 
this design certification rule on November 23, 1993, May 11 and 
December 4, 1995, and May 2 and July 15, 1996, in order to enhance 
public participation.
    The Commission has considered the comments received and made 
appropriate modifications to this design certification rule, as 
discussed in Sections II and III, and revised the numbering system used 
in the proposed rule. With these modifications, the Commission adopts 
as final this design certification rule, Appendix B to 10 CFR Part 52, 
for the System 80+ design.

[[Page 27841]]

II. Public Comment Summary and Resolution

    The public comment period for the proposed design certification 
rule, the design control document, and the environmental assessment for 
the System 80+ design expired on August 7, 1995. The NRC received 
twenty letters containing public comments on the proposed rule. The 
most extensive comments were provided by the Nuclear Energy Institute 
(NEI), in a letter dated August 4, 1995, which provided comments on 
behalf of the nuclear industry. In general, NEI commended the NRC for 
its efforts to provide standard design certifications but expressed 
serious concerns about aspects of the proposed rule that would, in 
NEI's view, undermine the goals of design certification. These concerns 
are addressed in the following responses to the public comments. 
Fourteen utilities and three vendors also provided comments. All of 
these comment letters endorsed the NEI comments of August 4, 1995, and 
some provided additional comments. The Department of Energy and the 
Ohio Citizens for Responsible Energy, Inc. (OCRE) also submitted 
comment letters.
    The NRC received other letters that were entered into the docket 
and are part of the record of the rulemaking proceeding, including an 
August 4, 1995 letter from NEI to the Chairman of the NRC, which 
submitted a copy of the Executive Summary of their public comment 
letter, and a May 11, 1995 letter, which provided suggestions on 
finality, secondary references, and other explanatory material. Also, 
the NRC received a second letter from Combustion Engineering, Inc., 
which provided proposed SOC that conformed with its comments.
    On February 6, 1996, the NRC staff issued SECY-96-028, ``Two Issues 
for Design Certification Rules,'' which requested the Commission's 
approval of the staff's position on two major issues raised by NEI in 
its comments on the proposed design certification rules. The NRC staff 
issued this paper because of fundamental disagreements with the nuclear 
industry on the need for applicable regulations and the matters to be 
considered in verifying inspections, tests, analyses, and acceptance 
criteria (ITAAC). Both NEI and DOE commented on SECY-96-028 in letters 
dated March 5 and 13, 1996, respectively.
    On March 8, 1996, the Commission conducted a public meeting in 
which industry representatives and NRC staff presented their views on 
SECY-96-028. During this meeting, NEI and the NRC staff both indicated 
agreement on the ITAAC verification issue. Subsequently, in a staff 
requirements memorandum (SRM) dated March 21, 1996, the Commission 
requested the NRC staff to meet again with industry to try to resolve 
the issue of applicable regulations. The NRC staff met with 
representatives of ABB-CE, GE Nuclear Energy, and NEI in a public 
meeting on March 25, 1996 and were unable to reach agreement. As a 
result, the NRC staff provided revised resolutions of applicable 
regulations and ITAAC determinations in SECY-96-077, ``Certification of 
Two Evolutionary Designs,'' dated April 15, 1996, that superseded the 
proposals in SECY-96-028. SECY-96-077 addressed the comments on the 
proposed design certification rules and provided final design 
certification rules for the Commission's consideration. Subsequently, 
notice of a 30 day comment period for SECY-96-077 was published in the 
Federal Register (61 FR 18099), and the comment period was extended for 
an additional 60 days (61 FR 27027) at the request of NEI.
    In response to the supplementary comment period, ABB-CE, GE Nuclear 
Energy, and NEI submitted additional comments on the final design 
certification rules in letters dated July 23, 1996. Westinghouse also 
submitted comments in a letter dated July 24, 1996. NEI sent an 
unsolicited letter, dated September 23, 1996, to the Director of the 
Office of Nuclear Reactor Regulation on three design certification 
issues. NEI also sent a letter, dated September 16, 1996, to Chairman 
Jackson that provided additional information in response to questions 
that were asked by the Commission in its August 27, 1996 briefing on 
design certification rulemaking.
    The following discussion is separated into three groups: (1) 
Resolution of the principal issues raised by the commenters, (2) 
resolution of the NRC's specific requests for comment from the proposed 
rule, and (3) resolution of other issues raised by the commenters.

A. Principal Issues

1. Finality
    Comment Summary. The applicant and NEI submitted extensive comments 
on the scope of issues that were proposed to be accorded finality under 
10 CFR 52.63(a)(4), i.e. are not subject to re-review by the NRC or re-
litigation in hearings. In summary, both commenters argued that:
     The scope of issues accorded finality is too narrow;
     Changes made in accordance with the change process are not 
accorded finality;
     Changes approved by the NRC should have protection under 
10 CFR 52.63(a)(4);
     The rule does not provide finality in all subsequent 
proceedings;
     The rule should be clarified regarding finality of SAMDA 
evaluations;
     A de novo review is not required for design certification 
renewal;
     Finality for Technical Specifications; and
     Finality for Operational Requirements.
    These comments are found in ABB-CE Comment, B.1; NEI Comments dated 
August 4, 1995, Attachment B, pp. 1-23; NEI Comments dated July 23, 
1996, pp. 1-21; and NEI letter dated September 16, 1996.
    Response: Scope of issues accorded finality.
    The applicant and NEI took issue with the proposed rule's language 
limiting the scope of nuclear safety issues resolved to those issues 
``associated with'' the information in the FSER or Design Control 
Document (DCD). Each argued that there were many other documents which 
included and/or addressed issues whose status should be regarded as 
``resolved in connection with'' this design certification rulemaking. 
These additional documents include ``secondary references'' (i.e., DCD 
references to documents and information which are not contained in the 
DCD, including secondary references containing proprietary and 
safeguards information), docketed material, and the entire rulemaking 
record (refer to NEI Comments dated August 4, 1995, Attachment B, pp. 
6-9).
    The Commission has reconsidered its position and decided that the 
ambit of issues resolved by this rulemaking should be the information 
that is reviewed and approved in the design certification rulemaking, 
which includes the rulemaking record for the standard design. This 
position reflects the Commission's SRM on SECY-90-377, dated February 
15, 1991. Also, the Commission concludes that the set of issues 
resolved should be those that were addressed (or could have been 
addressed if they were considered significant) as part of the design 
certification rulemaking process. However, the Commission does not 
agree that all matters submitted on the docket for design certification 
should be accorded finality under 10 CFR 52.63(a)(4). Some of this 
information was neither reviewed nor approved and

[[Page 27842]]

some was not directly related to the scope of issues resolved by this 
rulemaking. Therefore, the final rule provides finality for all nuclear 
safety issues associated with the information in the FSER and 
Supplement No. 1, the generic DCD, including referenced information 
that is intended as requirements, and the rulemaking record.
    In adopting this final design certification rulemaking, the 
Commission also finds that the design certification does not require 
any additional or alternative design criteria, design features, 
structures, systems, components, testing, analyses, acceptance 
criteria, or additional justifications in support of these matters. 
Inherent in the concept of design certification by rulemaking is that 
all these issues which were addressed, or could have been addressed, in 
this rulemaking are resolved and therefore, may not be raised in a 
subsequent NRC proceeding. If this were not the case and one could 
always argue in a subsequent proceeding that an additional, 
alternative, or modified system, structure or component of a 
previously-certified design was needed, or additional justification was 
necessary, or a modification to the testing and acceptance criteria is 
necessary, there would be little regulatory certainty and stability 
associated with a design certification. The underlying benefits of 
certification of individual designs by rulemaking, e.g., early 
Commission consideration and resolution of design issues and early 
Commission consideration and agreement on the methods and criteria for 
demonstrating completion of detailed design and construction in 
compliance with the certified design, would be virtually negated. Thus, 
in accord with the views of the applicant and NEI, the Commission 
clarifies and makes explicit its previously implicit determination that 
the scope of issues resolved in connection with the design 
certification rulemaking includes the lack of need for alternative, 
additional or modified design criteria, design features, structures, 
systems, components, or inspections, tests, analyses, acceptance 
criteria or justifications, and such matters may not be raised in 
subsequent NRC proceedings.
    In the statements of consideration (SOC) for the proposed rule, the 
Commission proposed that issues associated with ``requirements'' in 
secondary references, not specifically approved for incorporation by 
reference by the Office of the Federal Register (OFR) because they 
contained proprietary information, would not be considered resolved in 
the design certification rulemaking within the meaning of 10 CFR 
52.63(a)(4) (See 60 FR 17924, 17934). NEI took exception to this 
position, arguing that issues arising from secondary references should 
be included in the set of issues resolved (See NEI Comments dated 
August 4, 1995, Attachment B, pp. 6-9). The Commission has determined 
that the set of issues resolved by this rulemaking embraces those 
issues arising from secondary references that are requirements for the 
certified design, including those containing proprietary information. 
This is consistent with the intent of 10 CFR part 52 that issues 
related to the design certification should be considered and resolved 
in the design certification rulemaking. However, since OFR does not 
approve of ``incorporation by reference'' of proprietary information, 
even though it was available to potential commenters on this proposed 
design certification rule (see 60 FR 17924; April 7, 1995), the 
Commission has included in VI.E of this appendix, a process for 
obtaining proprietary information at the time that notice of a hearing 
in connection with issuance of a combined license is published in the 
Federal Register. Such persons will have actual notice of the 
requirements contained in the proprietary information and, therefore, 
will be subject to the issue finality provisions of Section VI of this 
appendix.
    Changes made in accordance with the ``50.59-like'' change process. 
The proposed design certification rule included a change process 
similar to that provided in 10 CFR 50.59. Specifically, proposed 
Section 8(b)(5) provided ``that such changes open the possibility for 
challenge in a hearing'' for Tier 2 changes in accordance with the 
Commission's guidance in its SRM on SECY-90-377, dated February 15, 
1991. The NRC also believed that providing an opportunity for a hearing 
would serve to discourage changes that could erode the benefits of 
standardization. The applicant and NEI argued that Tier 2 departures 
under the ``Sec. 50.59-like'' process should not be subject to any 
opportunity for hearing but may only be challenged via a 10 CFR 2.206 
petition; and, therefore, should be subject to the special backfit 
restrictions of 10 CFR 52.63(a). For purposes of brevity, this 
discussion refers to both generic changes and plant-specific departures 
as ``changes.''
    The Commission has reconsidered and revised its position on issue 
resolution in connection with Tier 2 departures under the ``Sec. 50.59-
like'' process. Section 50.59 was originally adopted by the Commission 
to afford a Part 50 operating license holder greater flexibility in 
changing the facility as described in the FSAR while still assuring 
that safety-significant changes of the facility would be subject to 
prior NRC review and approval [refer to 27 FR 5491, 5492 (first 
column); June 9, 1962]. The ``unreviewed safety question'' definition 
was intended by the Commission to exclude from prior regulatory 
consideration those licensee-initiated changes from the previously NRC-
approved FSAR that could not be viewed as having safety significance 
sufficient to warrant prior NRC licensing review and approval. To put 
it another way, any change properly implemented pursuant to Sec. 50.59 
should continue to be regarded as within the envelope of the original 
safety finding by the NRC. Moreover, the departure process for Tier 2 
information, as specified in VIII.B of this appendix, includes 
additional restrictions derived from 10 CFR 52.63(b)(2), viz., the Tier 
2 change must not involve a change to Tier 1 information. Thus, the 
departure process (VIII.B.5), if properly implemented by an applicant 
or licensee, must logically result in departures which are both 
``within the envelope'' of the Commission's safety finding for the 
design certification rule and for which the Commission has no safety 
concern. Therefore, it follows that properly implemented departures 
from Tier 2 should continue to be accorded the same extent of issue 
resolution as that of the original Tier 2 information from which it was 
``derived.'' As a result, Section VI of this appendix has been amended 
to reflect the Commission's determination on issue resolution for Tier 
2 changes made in accordance with the departure process and to provide 
backfit protection for changes made in accordance with the processes of 
Section VIII of this appendix.
    However, the converse of this reasoning leads the Commission to 
reject the applicant's and NEI's contention that no part of the 
applicant's or licensee's implementation of the departure process 
(VIII.B.5) should be open to challenge in a subsequent licensing 
proceeding, but instead should be raised as a petition for enforcement 
action under 10 CFR 2.206. Because Sec. 2.206 applies to holders of 
licenses and is considered a request for enforcement action (thereby 
presenting some potential difficulties when attempting to apply this in 
the context of a combined license applicant), it is unclear why an 
applicant or licensee

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who departs from the design certification rule in noncompliance with 
the process (VIII.B.5) should nonetheless reap the benefits of issue 
resolution stemming from the design certification rule. An incorrect 
departure from the requirements of this appendix essentially places the 
departure outside of the scope of the Commission's safety finding in 
the design certification rulemaking. It follows that properly-founded 
contentions alleging such incorrectly-implemented departures cannot be 
considered ``resolved'' by this rulemaking. The industry also appears 
to oppose an opportunity for a hearing on the basis that there is no 
``remedy'' available to the Commission in a licensing proceeding that 
would not also constitute a violation of the Tier 2 backfitting 
restrictions applicable to the Commission and that in a comparable 
situation with an operating plant the proper remedy is enforcement 
action. However, for purposes of issue finality the focus should be on 
the initial licensing proceeding where the result of an improper change 
evaluation would simply be that the change is not considered resolved 
and no enforcement action is needed. Neither the applicant nor NEI 
provided compelling reasons why contentions alleging that applicants or 
licensees have not properly implemented the departure process 
(VIII.B.5) should be entirely precluded from consideration in an 
appropriate licensing proceeding where they are relevant to the subject 
of the proceeding.
    Although the Commission disagrees with the applicant and NEI over 
the admissibility of contentions alleging incorrect implementation of 
the departure process, the Commission acknowledges that they have a 
valid concern regarding whether the scope of the contentions will 
incorrectly focus on the substance of correctly-performed departures 
and the possible lengthened time necessary to litigate such matters in 
a hearing (see, e.g., Transcript of December 4, 1995, Public Meeting, 
p. 47). Therefore, the Commission has included an expedited review 
process (VIII.B.5.f), similar to that provided in 10 CFR 2.758, for 
considering the admissibility of such contentions. Persons who seek a 
hearing on whether an applicant has departed from Tier 2 information in 
noncompliance with the applicable requirements must submit a petition, 
together with information required by 10 CFR 2.714(b)(2), to the 
presiding officer. If the presiding officer concludes that a prima 
facie case has been presented, he or she shall certify the petition and 
the responses to the Commission for final determination as to 
admissibility.
    Subsequently, in its comments dated July 23, 1996, NEI requested 
the Commission to modify VIII.B.5.f to clarify that a ``50.59-like'' 
change is not subject to a hearing under Sec. 52.103 or Sec. 50.90 
unless the change bears directly on an asserted ITAAC noncompliance or 
the requested amendment, respectively. The Commission determined that 
NEI's proposed wording correctly stated its intention regarding the 
opportunity for a hearing on ``50.59-like'' departures after a license 
is issued and, therefore, VIII.B.5.f of this appendix has been 
appropriately modified.
    Changes approved by the NRC should have protection under Section 
52.63. NEI, in its comments dated July 23, 1996, requested the 
Commission to provide the special backfit protection of Sec. 52.63 to 
all changes to Tier 1, Tier 2*, and changes to Tier 2 that involve an 
unreviewed safety question or a change in the technical specifications. 
The special provision in Sec. 52.63(a)(4) states that ``* * * the 
Commission shall treat as resolved those matters resolved in connection 
with the issuance or renewal of a design certification.'' The 
Commission stated, in its SRM on SECY-90-377, that ``* * * the process 
provides issue finality on all information provided in the application 
that is reviewed and approved in the design certification rulemaking.'' 
The Commission also stated that ``* * * changes to the design reviewed 
and approved by the staff should be minimized * * *.'' Based on this 
guidance, the Commission decided that the special backfit provision 
should be extended to generic changes made to the DCD that are approved 
by rulemaking. Also, for departures that are approved by license 
amendment or exemption, the Commission decided that the licensee of 
that plant should receive the special backfit protection. However, any 
other licensee that references the same DCD should not have finality 
for that plant-specific departure, unless it was again approved by 
license amendment or exemption for that licensee.
    Finality in all subsequent proceedings. NEI requested that Section 
6 of the proposed rule be expanded to include a more detailed statement 
regarding the findings, issues resolved, and restrictions on the 
Commission's ability to ``backfit'' this appendix. The Commission 
agrees that the industry's proposal has some merit, and has revised 
Section VI of this appendix, beginning with the general subjects 
embodied in NEI's proposed redraft, but restructured the NEI proposal 
into three sections to reflect the scope of issues resolved, change 
process, and rulemaking findings, thereby conforming the language to 
reflect the conventions of the appendix (e.g., generic changes versus 
plant-specific departures), and making minor editorial changes for 
clarity and consistency. However, one area in which the Commission 
declines to adopt the industry's proposal is the inclusion of a 
statement that extends issue finality to all subsequent proceedings.
    Section 52.63(a)(4) explicitly states that issues resolved in a 
design certification rulemaking have finality in combined license 
proceedings, proceedings under Sec. 52.103, and operating license 
proceedings. There are other NRC proceedings not mentioned in 
Sec. 52.63(a)(4), e.g., combined license amendment proceedings and 
enforcement proceedings, in which the design certification should 
logically be afforded issue resolution and, therefore, are included in 
Section VI of this appendix. However, NEI listed NRC proceedings such 
as design certification renewal proceedings, for which issue finality 
would not be appropriate. Moreover, it should be understood that to say 
that this design certification rule is accorded ``issue finality'' does 
not eliminate changes properly made under the change restrictions in 
Section VIII of this appendix. Therefore, the Commission declines to 
adopt in its entirety the industry proposal that issue finality should 
extend to all subsequent NRC proceedings.
    In its comments dated July 23, 1996, NEI requested the Commission 
to modify the last phrase of Section 6(b), of SECY-96-077, to reflect 
the NRC staff's intent regarding finality in enforcement proceedings. 
Section 6(b) stated that the DCD has finality in enforcement 
proceedings ``where these proceedings reference this appendix.'' NEI 
was concerned that this phrase could be construed as depriving finality 
to plants that reference the design certification rules in enforcement 
proceedings that do not explicitly reference the design certification 
rule. The intent of the phrase was to limit finality of the information 
in the design certification rule to enforcement proceedings involving a 
plant referencing the rule. Therefore, the Commission replaced the 
wording, ``where these proceedings reference this appendix,'' with 
``involving plants referencing this appendix'' in Section VI.B of the 
final rules.
    Finality regarding SAMDA evaluations. In its comments dated July 
23, 1996, NEI requested the Commission to extend finality for the SAMDA 
evaluation when an exemption from a

[[Page 27844]]

site parameter specified in the evaluation has been approved. Section 
VI.B.7 of this appendix accords finality to severe accident mitigation 
design alternatives (SAMDAs) for plants referencing the design 
certification rules ``whose site parameters are within those specified 
in the Technical Support Document'' (TSD). NEI is concerned that the 
last phrase could open all SAMDAs to re-review and re-litigation during 
a subsequent proceeding where the licensee has requested an exemption 
from a site parameter specified in the DCD, even though the exemption 
has no impact on the SAMDAs. NEI also stated that a clarification to 
the SOC was not sufficient and believed that a modification to the rule 
language was needed.
    The NRC staff agrees that it was not the intent to re-litigate 
SAMDA issues under such circumstances. The intent was that an 
intervenor in any subsequent proceeding could challenge a SAMDA based 
on an exemption to a TSD site parameter only after bringing forward 
evidence demonstrating that the SAMDA analysis was invalidated. 
However, the NRC staff does not agree that the wording should be 
changed. NEI's proposed modification would shift the burden of 
demonstrating the acceptability of the exemption from the licensee. 
Moreover, it would be difficult to extend the NEPA review to all 
available sites without any qualification. Therefore, the Commission 
decided not to change Section VI.B.7 of this appendix but did explain 
in section III.F of this SOC that requests for litigation must meet 
Sec. 2.714 requirements.
    A de novo review is not required for design certification renewal. 
In its comments dated July 23, 1996, NEI requested the Commission to 
extend finality to design certification renewal proceedings and to 
define a review procedure for renewal applications that would limit the 
scope of review. Subsequently, NEI stated in a letter dated September 
23, 1996, that principles for renewal reviews can and should be 
established in the design certification rules. The extension of 
finality to a renewal proceeding would produce the illogical result 
that the NRC's conclusion in the original design certification 
rulemaking, that the design provided adequate protection and was in 
compliance with the applicable regulations, would also apply to the 
renewal review even though the regulations in Part 52 require another 
review and finding at the renewal stage 15 years later. The effect of 
this extension would be to extend the design certification for another 
15 years (for a total of 30 years) instead of the intended 15 years.
    The NRC staff agrees with NEI that the renewal review must be 
conducted against the Commission's regulations applicable and in effect 
at the time of the original certification, and that the backfit 
limitations in Sec. 52.59 must be satisfied in order to require a 
change to the certified design. However, the NRC staff disagrees with 
NEI's position that the information to be considered in the renewal 
review is limited to ``an evaluation of experience between the time of 
certification and the renewal application,'' as well as NEI's 
implication that the scope of the design for which new information can 
be considered is limited to those areas which the design certification 
applicant concedes there is new information or proposes a modification. 
The effect of NEI's position would be to preclude the NRC from 
considering new information which could have altered the Commission's 
consideration and approval of the design had it been known at the time 
of the original certification review, and to cede control of the scope 
of the renewal review to the design certification applicant. 
Furthermore, the review procedure for a renewal application is not 
dependent on whether the applicant proposed changes to the previously 
certified design. The underlying philosophy was that new safety 
requirements and issues that arose during the duration of the design 
certification rule could not be applied to the certified design (unless 
the adequate protection standard was met). However, these issues could 
be raised for consideration at the renewal stage and applied to the 
application for renewal if the backfit standard in Sec. 52.59 was met. 
Therefore, any portion of the certified design could be reviewed 
(subject to Sec. 52.59) to ensure that the applicable regulations for 
the certified design are being met based on consideration of new 
information (e.g. operating experience, research, or analysis) 
resulting from the previous 15 years of experience with the design.
    The Commission rejects NEI's proposal to apply the finality 
provision of Sec. 52.63 to the review of renewal applications because 
this would suggest improperly that NRC, in its renewal review, is bound 
by previous safety conclusions in the initial certification review. The 
type of renewal review was resolved by the Commission during the 
development of 10 CFR Part 52. At that time, the Commission determined 
that the backfit standard in Sec. 52.59(a) controls the development of 
new requirements during the review of applications for renewal. 
Therefore, the Commission disagrees with NEI's proposed revision to 
Section 6(b), in its letter dated September 23, 1996, and NEI's 
proposal for a new Section 6(e) is unnecessary because this process is 
already correctly covered in Sec. 52.59.
    The Commission does not plan or expect to be able to conduct a de-
novo review of the entire design if a certification renewal application 
is filed under Sec. 52.59. It expects that the review focus would be on 
changes to the design that are proposed by the applicant and insights 
from relevant operating experience with the certified design or other 
designs, or other material new information arising after the NRC 
staff's review of the design certification. The Commission will defer 
consideration of specific design certification renewal procedures until 
after it has issued this appendix.
    Finality for Technical Specifications. In its comments dated August 
4, 1995, Attachment B (pp. 124-129), NEI requested that the NRC 
establish a single set of integrated technical specifications governing 
the operation of each plant that references this design certification 
and that the technical specifications be controlled by a single change 
process. In the proposed rule, the NRC included the technical 
specifications for the standard designs in the generic DCD in order to 
maximize the standardization of the technical specifications for plants 
that reference this design certification. As a result, a plant that 
references this design certification would have two sets of technical 
specifications associated with its license: (1) Technical 
specifications from Chapter 16 of Tier 2 of the generic DCD and 
applicable to the standardized portion of the plant, and (2) those 
technical specifications applicable to the site-specific portion for 
the plant. While each portion of the technical specifications would be 
subject to a different change process, the substantive aspects of the 
change processes would be essentially the same.
    In the design certification rule that was attached to SECY-96-077, 
the technical specifications were removed from Tier 2 for two reasons. 
First, the removal from Tier 2 responded to NEI's comment regarding a 
single change process. NEI's proposal to include the technical 
specifications in Tier 2 prior to issuance of a combined license (COL), 
and then remove them after COL issuance is not acceptable. If the 
technical specifications are included in Tier 2 by the design 
certification rulemaking, they would remain there and be controlled by 
the Tier 2 change process for the life of the facility. Second, the NRC 
staff wanted the ability

[[Page 27845]]

to impose future operational requirements and standards (distinct from 
design matters) on the technical specifications for a plant that 
referenced the certified design and Section 4(c) of the rule in SECY-
96-077 provided that ability. However, Section 4(c) would not be used 
to backfit design features (i.e., hardware changes) unless the criteria 
of Sec. 52.63 were met.
    In its comments dated July 23, 1996, NEI requested the Commission 
to extend finality to the technical specifications in Chapter 16 of the 
DCD. NEI stated that the technical specifications in the DCDs should 
remain part of the design certification and be accorded finality 
because they have been reviewed and approved by the NRC. NEI also 
proposed that, after the license is granted, the technical 
specifications in the DCD would no longer have any relevance to the 
license and there would be a single set of technical specifications 
that will be controlled by the 10 CFR 50.90 license amendment process 
and subject to the backfit provisions in 10 CFR 50.109.
    The Commission does not support extension of the special backfit 
provisions of Sec. 52.63 to technical specifications and other 
operational requirements as requested by NEI, rather the Commission 
supports the proposal to treat the technical specifications in Chapter 
16 of the DCD as a special category of information, as described in the 
NRC staff's comment analyses dated August 13 and October 21, 1996. The 
purpose of design certification is to review and approve design 
information. There is no provision in Subpart B of 10 CFR Part 52 for 
review and approval of purely operational matters. The Commission 
approves a revised Section VIII.C of this appendix that would apply to 
the technical specifications, bases for the technical specifications, 
and other operational requirements in the DCD; that would provide for 
use of Sec. 52.63 only to the extent the design is changed; and that 
would use Sec. 2.758 and Sec. 50.109 to the extent an NRC safety 
conclusion is being modified or changed but no design change is 
required. In applying Sec. 2.758 and Sec. 50.109, it will be necessary 
to determine from the certification rulemaking record what safety 
issues were considered and resolved. This is because Sec. 2.758 will 
not bar review of a safety matter that was not considered and resolved 
in the design certification rulemaking. There would be no backfit 
restriction under Sec. 50.109 because no prior position was taken on 
this safety matter. After the COL is issued, the set of technical 
specifications for the COL (the combination of plant-specific and DCD 
derived) would be subject to the backfit provisions in Sec. 50.109 
(assuming no Tier 1 or Tier 2 changes are involved).
    Finality for operational requirements. A new provision was included 
in the design certification rules, set forth in Section 4(c), that were 
attached to SECY-96-077. The reason for this provision was that the 
operational requirements in the DCD had not received a complete and 
comprehensive review. Therefore, the new Section 4(c) was needed to 
reserve the right of the Commission to impose operational requirements 
on plants referencing this appendix, such as license conditions for 
portions of the plant within the scope of this design certification, 
e.g., start-up and power ascension testing. NEI claimed, in its 
comments dated July 23, 1996, that the backfit provisions in Section 
4(c) contradicted 10 CFR 52.63 and were incompatible with the purpose 
of 10 CFR part 52.
    NEI's claim that Section 4(c) contradicts 10 CFR 52.63 and enables 
the NRC to impose changes to the design information in the DCD without 
regard to the special backfit provisions of Sec. 52.63 is wrong. 
Section 4(c) clearly referred to ``facility operation'' not ``facility 
design.'' The purpose of Section 4(c) was to ensure that any necessary 
operational requirements could be applied to plants that reference 
these certified designs because plant operational matters were not 
finalized in the design certification review. It was also clear that 
the NRC staff considered resolved design matters to be final. Refer to 
SECY-96-077 which states: ``Most importantly, a provision has been 
included in Section 4 to provide that the final rules do not resolve 
any issues regarding conditions needed for safe operation (as opposed 
to safe design).'' This is consistent with the goal of design 
certification, which is to preserve the resolution of design features, 
which are explicitly discussed or inferred from the DCD. The backfit 
provisions in Sections VIII.A and VIII.B of this appendix control 
design changes.
    Subsequently, in its comments of September 23, 1996, NEI requested 
that all DCD requirements, including operational-related and other non-
hardware requirements, be accorded finality under Sec. 52.63. The 
Commission has determined that NEI's proposal to assign finality to 
operational requirements is unacceptable, because operational matters 
were not comprehensively reviewed and finalized for design 
certification (refer to section III.F of this SOC). Although the 
information in the DCD that is related to operational requirements was 
necessary to support the NRC's safety review of the standard designs, 
the review of this information was not sufficient to conclude that the 
operational requirements are fully resolved and ready to be assigned 
finality under Sec. 52.63. Therefore, the Commission retained the 
former Section 4(c), but reworded this provision on operational 
requirements and placed it in Section VI.C of this appendix with the 
other provisions on finality (also refer to Section VIII.C of this 
appendix).
2. Tier 2 Change Process
    Comment Summary. NEI submitted many comments on the following 
aspects of the Tier 2 change process:
     Scope of the change process in VIII.B.5;
     Post-design certification rulemaking changes to Tier 2 
information;
     Restrictions on Tier 2* information; and
     Additional aspects of the change process.
    Response. The proposed design certification rule provided a change 
process for Tier 2 information that had the same elements as the Tier 1 
change process in order to implement the two-tiered rule structure that 
was requested by industry. Specifically, the Tier 2 change process in 
Section 8(b) of the proposed rule provided for generic changes, plant-
specific changes, and exemptions similar to the provisions in 10 CFR 
52.63, except that some of the standards for plant-specific orders and 
exemptions are different. Section 8(b) also had a provision similar to 
10 CFR 50.59 that allows for departures from Tier 2 information by an 
applicant or licensee, without prior NRC approval, subject to certain 
restrictions, in accordance with the Commission's SRM on SECY-90-377, 
dated February 15, 1991.
    Scope of the change process in VIII.B.5. In its comments dated 
August 4, 1995, Attachment B, pp. 67-82, NEI raised a concern regarding 
application of the Sec. 50.59-like change process to severe accident 
information, and stated:

    Instead of applying the Sec. 50.59-like process to all of 
Chapter 19, we propose (1) that the process be applied only to those 
sections that identify features that contribute significantly to the 
mitigation or prevention of severe accidents (i.e., Section 19.8 for 
the ABWR and Section 19.15 for the System 80+), and (2) that changes 
in these sections should constitute unreviewed safety questions only 
if they would result in a substantial increase in the probability or 
consequences of a severe accident.

    The Commission agrees that departures from Tier 2 information that 
describe the resolution of severe accident issues should use criteria 
that

[[Page 27846]]

is different from the criteria in 10 CFR 50.59 for determining if a 
departure constitutes an unreviewed safety question (USQ). Because of 
the increased uncertainty in severe accident issue resolutions, the NRC 
has included ``substantial increase'' criteria in VIII.B.5.c of this 
appendix for Tier 2 information that is associated with the resolution 
of severe accident issues. The (Sec. 50.59-like) criteria in VIII.B.5.b 
of this appendix, for determining if a departure constitutes a USQ, 
will apply to the remaining 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 must be based on the criteria in VIII.B.5.b of this 
appendix.
    However, NEI misidentified the sections of the DCD that describe 
the resolutions of the severe accident issues. Section 19.8 for the 
U.S. ABWR and Section 19.15 for the System 80+ design identify 
important features that were derived from various analyses of the 
design, such as seismic analyses, fire analyses, and the probabilistic 
risk assessment. This information was used in preparation of the Tier 1 
information and, as stated in the proposed rule, it should be used to 
ensure that departures from Tier 2 information do not impact Tier 1 
information. For these reasons, the Commission rejects the contention 
that the severe accident resolutions are contained in Section 19.15 of 
the generic DCD.
    Subsequently, in its comments dated July 23, 1996, NEI requested 
the Commission to expand the scope of design information that is 
controlled by the special change process for severe accident issues to 
all of the information in Chapter 19 of the DCD. The NRC staff intended 
that this special change process be limited to severe accident design 
features, where the intended function of the design feature is relied 
upon to resolve postulated accidents when the reactor core has melted 
and exited the reactor vessel and the containment is being challenged 
(severe accidents). These design features are identified in Section 
19.11 of the System 80+ DCD and Section 19E of the ABWR DCD. This 
special change process was not intended for design features that are 
discussed in Chapter 19 for other reasons, such as resolution of 
generic safety issues. However, the NRC staff recognizes that the 
severe accident design features identified in Section 19.11 are 
described in other areas of the DCD. Therefore, the location of design 
information is not important to the application of the special change 
process for severe accident issues and it is not specified in Section 
VIII.B.5. The importance of this provision is that it be limited to the 
severe accident design features. In addition, the Commission is 
cognizant of certain design features that have intended functions to 
meet ``design basis'' requirements and to resolve ``severe accidents.'' 
These design features will be reviewed under either VIII.B.5.b or 
VIII.B.5.c depending upon the design function being changed. Finally, 
the Commission rejects NEI's request to expand the scope of design 
information that is controlled by the special change process for severe 
accident issues.
    Post-design certification rulemaking changes to Tier 2 information. 
In its comments dated August 4, 1995, Attachment B, pp. 83-89, NEI 
requested that the NRC add a Sec. 50.59-like provision to the change 
process that would allow design certification applicants to make 
generic changes to Tier 2 information prior to the first license 
application. These applicant-initiated, post-certification Tier 2 
changes would be binding upon all referencing applicants and licensees 
(i.e., referencing applicants and licensees must comply with all such 
changes) and would continue to enjoy ``issue preclusion'' (i.e., issues 
with respect to the adequacy of the change could not be raised in a 
subsequent proceeding as a matter of right). However, the changes would 
not be subject to public notice and comment. Instead NEI proposed that 
the changes would be considered resolved and final (not subject to 
further NRC review) six months after submission, unless the NRC staff 
informs the design certification applicant that it disagrees with the 
determination that no unreviewed safety question exists.
    The Commission declines to adopt the NEI proposal. The applicant-
initiated Tier 2 changes proposed by NEI have the essential attributes 
of a ``rule,'' and the process of NRC review and ``approval'' (negative 
consent) would appear to be ``rulemaking,'' as these terms are defined 
in Section 551 of the APA. Section 553(b) of the APA requires public 
notice in the Federal Register and an opportunity for public comment 
for all rulemakings, except in certain situations delineated in Section 
553(b) (A) and (B) which are not applicable to applicant-initiated 
changes. The NEI proposal conflicts with the rulemaking requirements of 
the APA. If the NEI proposal is based upon a desire to permit the 
applicant to disseminate worthwhile Tier 2 changes, there are three 
alternatives already afforded by Part 52 and this appendix. The 
applicant (as any member of the public) may submit a petition for 
rulemaking pursuant to Subpart H of 10 CFR Part 2, to modify this 
design certification rule to incorporate the proposed changes to Tier 
2. If the Commission grants the petition and adopts a final rule, the 
change is binding on all referencing applicants and licensees in 
accordance with VIII.B.2 of this appendix. Also, the applicant could 
develop acceptable documentation to support a Tier 2 departure in 
accordance with VIII.B of this appendix. This documentation could be 
submitted for NRC staff review and approval, similar to the manner in 
which the NRC staff reviews topical reports.1 Finally, the 
applicant could provide its proposed changes to a COL applicant who 
could seek approval as part of its COL application review. The 
Commission regards these regulatory approaches to be preferable to the 
NEI proposal. However, if NEI is requesting that the Commission change 
its preliminary determination, as set forth in its February 15, 1991 
SRM on SECY-90-377, that generic Tier 2 rulemaking changes be subject 
to the same restrictive standard as generic Tier 1 changes, the 
Commission declines to do so. The Commission believes that maintaining 
a high standard for generic changes to both Tier 1 and Tier 2 will 
ensure that the benefits of standardization are appropriately achieved.
---------------------------------------------------------------------------

    \1\ Topical reports, which are usually submitted by vendors such 
as GE, Westinghouse, and Combustion Engineering, request NRC staff 
review and approval of generic information and approaches for 
addressing one or more of the Commission's requirements. If the 
topical report is approved by the NRC staff, it issues a safety 
evaluation setting forth the bases for the staff's approval together 
with any limitations on referencing by individual applicants and 
licensees. Applicants and licensees may incorporate by reference 
topical reports in their applications, in order to facilitate timely 
review and approval of their applications or responses to requests 
for information. However, limitations in NRC resources may affect 
review schedules for these topical reports.
---------------------------------------------------------------------------

    Subsequently, in its comments dated July 23, 1996, NEI requested 
the Commission to modify this SOC to reflect NRC openness to discuss a 
post-design certification change process and related issues after the 
design certification rules are completed. The Commission has determined 
that vendors who submit a design, which is subsequently certified by 
rulemaking, may not make changes under a ``50.59-like'' process and 
that NEI's request is outside the scope of this rulemaking. The 
Commission believes that vendors should be limited in making changes to 
rulemaking to amend the certification and that this appendix provides 
an appropriate process for making generic

[[Page 27847]]

changes to the DCD (refer to the SRM on SECY-90-377 and the SOC for 10 
CFR Part 52, Section II.1.h). This process is available to everyone and 
the standard for changes is the same for NRC, the applicant, and the 
public. This restrictive change process is consistent with the NRC's 
goal of achieving and preserving resolutions of safety issues to 
provide a stable and predictable licensing process.
    Restrictions on Tier 2* information. In its comments dated August 
4, 1995, Attachment B, pp. 119-123, and in subsequent comments dated 
July 23, 1996, pp. 50-54, NEI requested that the restriction on 
departures from all Tier 2* information expire at first full power and, 
in any event, the expiration of the restrictions should be consistent 
for both the U.S. ABWR and System 80+ designs. The Commission stated in 
the proposed design certification rule that the restriction on changing 
Tier 2* information resulted from the development of the Tier 1 
information in the generic DCD. 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 an applicant or licensee who 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 
significant information only exists in Tier 2 and the Commission does 
not want this significant information to be changed without prior NRC 
approval. This Tier 2* information is identified in the generic DCD 
with italicized text and brackets.
    Although the Tier 2* designation was originally intended to last 
for the lifetime of the facility, like Tier 1 information, the NRC 
staff reevaluated the duration of the change restriction for Tier 2* 
information during the preparation of the proposed rule. The NRC staff 
determined that some of the Tier 2* information could expire when the 
plant first achieves full (100%) power, after the finding required by 
10 CFR 52.103(g), while other Tier 2* information must remain in effect 
throughout the life of the plant that references this rule. The 
determining factors were the Tier 1 information that would govern these 
areas after first full power and the NRC staff's judgement on whether 
prior approval was required before implementation of the change due to 
the significance of the information.
    As a result of NEI's comments, the NRC again reevaluated the 
duration of the Tier 2* change restrictions. The NRC agrees with NEI 
that expiration of Tier 2* information for the two evolutionary designs 
should be consistent, unless there is a design-specific reason for a 
different treatment. The NRC decided that the Tier 2* restrictions for 
equipment seismic qualification methods and piping design acceptance 
criteria could expire at first full power, because the approved 
versions of the ASME code provide sufficient control of Tier 2* changes 
for these two areas. However, for fuel and control rod design, the 
licensing criteria had not been developed sufficiently when the System 
80+ DCD was prepared and, therefore, the Tier 2* designation was not 
applied to the licensing acceptance criteria for System 80+ but was 
applied to specific parameters of the initial core load. Consequently, 
many changes to ABB-CE fuel designs, including relatively minor changes 
and reload calculations, must be submitted to the NRC for review 
following the first fuel cycle. Also, the NRC decided that the Tier 2* 
change restriction for control room human factors engineering cannot 
expire for the System 80+ design at first full power because there is 
insufficient control over the implementation process in Tier 1.
    Recent industry proposals for currently operating core fuel designs 
have indicated a desire to modify the fuel burnup limit design 
parameter. However, operational experience with fuel with extended fuel 
burnup has indicated that cores should not be allowed to operate beyond 
the burnup limits specified in the generic DCDs without NRC approval. 
This experience is summarized in a Commission memorandum from James M. 
Taylor, ``Reactivity Transients and High Burnup Fuel,'' dated September 
13, 1994, including Information Notice (IN) 94-64, ``Reactivity 
Insertion Transient and Accident Limits for High Burnup Fuel,'' dated 
August 31, 1994. Experimental data on the performance of high burnup 
fuel under reactivity insertion conditions became available in mid-
1993. The NRC issued IN 94-64 and IN 94-64, Supplement 1, on April 6, 
1995, to inform industry of the data. The unexpectedly low energy 
deposition to initiation of fuel failure in the first test rod (at 62 
GWd/MTU) led to a re-evaluation of the licensing basis assumptions in 
the NRC's standard review plan (SRP). The NRC performed a preliminary 
safety assessment and concluded that there was no immediate safety 
issue for currently operating cores because of the low to medium burnup 
status of the fuel (refer to Commission Memorandum from James M. 
Taylor, ``Reactivity Transients and Fuel Damage Criteria for High 
Burnup Fuel,'' dated November 9, 1994, including an NRR safety 
assessment and the joint NRR/RES action plan). Therefore, the NRC has 
determined that additional actions by industry are not needed to 
justify current burnup limits for operating reactor fuel designs. 
However, the NRC has determined that it needs to carefully consider any 
proposed changes to the fuel burnup parameter in the generic DCDs for 
these fuel designs until further experience is gained with extended 
fuel burnup characteristics. Requests for extension of these burnup 
limits will be evaluated based on supporting experimental data and 
analyses, as appropriate, for current and advanced fuel designs. 
Therefore, the NRC has determined that the Tier 2* designation for the 
fuel burnup parameters should not expire for the lifetime of a 
referencing facility.
    NEI also stated in its comments dated July 23, 1996, that to the 
extent the Commission does not adopt its recommendation that all Tier 
2* restrictions expire at first full power, the SOC should be modified 
to reflect the NRC staff's intent that Tier 2* material in the DCD may 
be superseded by information submitted with a license application or 
amendment. The Commission decided that, if certain Tier 2* information 
is changed in a generic rulemaking, the category of the new information 
(Tier 1, 2*, or 2) would also be determined in the rulemaking and the 
appropriate process for future changes would apply. If certain Tier 2* 
information is changed on a plant-specific basis, then the appropriate 
modification to the change process would apply only to that plant.
    Additional aspects of the change process. In its comments dated 
August 4, 1995, Attachment B, pp. 109-118, NEI raised some additional 
concerns with the Tier 2 change process. The first concern was with the 
process for determining if a departure from Tier 2 information 
constituted an unreviewed safety question. Specifically, NEI identified 
the following statement in section III.H of the SOC for the proposed 
rule. ``* * * if the change involves an issue that the NRC staff has 
not previously approved, then NRC approval is required.'' A 
clarification of this statement was provided in the May 11, 1995 public 
meeting on design certification (pp. 12-14 of meeting transcript), when 
the NRC staff stated that the NRC was not creating a new criterion for 
determining unreviewed

[[Page 27848]]

safety questions but was explaining existing criteria. A further 
discussion of this statement took place between the staff and counsel 
to GE Nuclear Energy at the December 4, 1995 public meeting on design 
certification (pp. 53-56 of meeting transcript), in which counsel for 
GE Nuclear Energy agreed that a departure which creates an issue that 
was not previously reviewed by the NRC would be evaluated against the 
existing criteria for determining whether there was an unreviewed 
safety question. The Commission does not believe there is a need for a 
change to the language of this appendix. The statement above was not 
included in section III.H of this SOC.
    NEI also requested that Section 8(b) of the proposed rule be 
revised to state that exemptions are not required for changes to the 
technical specifications or Tier 2* information that do not involve an 
unreviewed safety question. The Commission has determined that this is 
consistent with the Commission's intent that permitted departures from 
Tier 2* under VIII.B of this appendix should not also require an 
exemption, unless otherwise required by, or implied by 10 CFR part 52, 
Subpart B and, accordingly, has revised paragraph VIII.B.6 of this 
appendix. As discussed above, the technical specifications in Chapter 
16 of the generic DCD are not in Tier 2 and, in its comments dated 
September 23, 1996, NEI proposed that requested departures from Chapter 
16 by an applicant for a COL require an exemption. The Commission 
agrees with NEI's new position and included this provision in Section 
VIII.C of this appendix. NEI also raised a concern with the requirement 
for quarterly reporting of design changes during the construction 
period. This issue is discussed in section III.J of this SOC.
    Finally, NEI raised a concern with the status of 10 CFR 52.63(b)(2) 
in the two-tiered rule structure that has been implemented in this 
appendix and claimed that 10 CFR 52.63(b) clearly embodies a two-tier 
structure. NEI's claim is not correct. The Commission adopted a two-
tiered design certification rule structure (Commission SRM on SECY-90-
377, dated February 15, 1991) and created a change process for Tier 2 
information that has the same elements as the Tier 1 change process. In 
addition, the Tier 2 change process includes a provision that is 
similar to 10 CFR 50.59, namely VIII.B.5 of this appendix. Therefore, 
as stated in section II (Topic 6) of the proposed rule, there is no 
need for 10 CFR 52.63(b)(2) in the two-tiered change process that has 
been implemented for this appendix.
    Subsequently, in its comments dated July 23, 1996, NEI requested 
the Commission to modify Section VIII.B.4 of this appendix so that 
exemption requests are only subject to an opportunity for a hearing. 
The Commission decided that NEI's proposal was consistent with the 
intent of this appendix and modified Section VIII.B.4, accordingly. 
Also, NEI requested the Commission to modify Section VIII.B.6.b of this 
appendix to restrict the need for a license amendment and an 
opportunity for a hearing to those Tier 2* changes involving unreviewed 
safety questions. NEI claimed that a hearing opportunity for Tier 2* 
changes was unnecessary and should be provided only if the change 
involves an unreviewed safety question. The Commission disagrees with 
NEI because of the safety significance of the Tier 2* information. The 
safety significance of the Tier 2* information was determined at the 
time that the Tier 1 information was selected. Any changes to Tier 2* 
information will require a license amendment with the appropriate 
hearing opportunity.
3. Need for Additional Applicable Regulations
    Comment Summary. NEI and the other industry commenters criticized 
Section 5(c) of the proposed design certification rule, which 
designated additional applicable regulations for the purposes of 10 CFR 
52.48, 52.54, 52.59, and 52.63 (refer to NEI Comments dated August 4, 
1995, Attachment B, pp. 24-57; NEI Comments dated July 23, 1996, pp. 
27-34; and NEI letter dated September 16, 1996).
    Response. NEI raised many issues in its comments. These comments 
have been consolidated into the following groups to facilitate 
documentation of the NRC staff's responses.
    NEI stated that there is no requirement in 10 CFR Part 52 that 
compels the Commission to adopt these new applicable regulations, that 
the new applicable regulations are not necessary for adequate 
protection or to improve the safety of the standard designs, and that 
the applicable regulations are inconsistent with the Commission's SRM, 
dated September 14, 1993. NEI also stated that the adoption of new 
applicable regulations is contrary to the purpose of design 
certification and Commission policy. The NRC staff developed the new 
applicable regulations in accordance with the goals of 10 CFR part 52, 
Commission guidance, and to achieve the purposes of 10 CFR 52.48, 
52.54, 52.59, and 52.63 (refer to SECY-96-028, dated February 6, 1996, 
and the History of Applicable Regulations in Attachment 9 to SECY-96-
077, dated April 15, 1996). The Commission chose design-specific 
rulemaking rather than generic rulemaking for the new technical and 
severe accident issues. The Commission adopted this approach early in 
the design certification review process because it was concerned that 
generic rulemakings would cause significant delay in the design 
certification reviews and it was thought that the new requirements 
would be design-specific (refer to SRMs on SECY-91-262 and SECY-93-
226). Furthermore, the SOC discussion for Part 52, Section II.1.e, 
``Applicability of Existing Standards,'' states that new standards may 
be required and that these new standards may be developed in a design-
specific rulemaking.
    NEI stated that the applicable regulations are unnecessary because 
the NRC staff has applied these technical positions in reviewing and 
approving the standard designs. In addition, each of these positions 
has corresponding NRC staff approved provisions in the respective 
design control documents (DCD) and these provisions already serve the 
purpose of applicable regulations for all of the situations identified 
by the NRC staff. In response, the NRC staff stated that NEI's 
statement that information in the DCD will constitute an applicable 
regulation confuses the difference between design descriptions approved 
by rulemaking and the regulations (safety standards) that are used as 
the basis to approve the design. Furthermore, during a meeting on April 
25, 1994, and in a letter from Mr. Dennis Crutchfield (NRC) to Mr. 
William Rasin (NEI), dated July 25, 1994, the NRC staff stated that 
design information cannot function as a surrogate for the new (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 previously approved design 
descriptions.
    NEI was also concerned that ``broadly stated'' applicable 
regulations could be used in the future by the NRC staff to impose 
backfits on applicants and licensees that could not otherwise be 
justified on the basis of adequate protection of public health and 
safety, thereby eroding licensing stability. However, NEI acknowledged 
in its comments that the NRC staff did not intend to reinterpret the 
applicable regulations to impose compliance backfits and because 
implementation of the applicable regulations was approved in the DCD, 
the NRC staff could not impose a backfit on the approved

[[Page 27849]]

implementation without meeting the standards in the change process. 
Also, NEI claimed that the additional applicable regulations were vague 
and, in some cases, inconsistent with previous Commission directions. 
In response to NEI's comments, the NRC staff proposed revised wording 
and a special provision for compliance backfits to the additional 
applicable regulations (refer to SECY-96-077). However, in subsequent 
comments, NEI stated that the proposed wording changes and backfit 
provision did not mitigate its concerns.
    NEI commented in 1995 that some of the additional applicable 
regulations are requirements on an applicant or licensee who references 
this appendix, and requested in 1996 that these requirements be deleted 
from the final rule. The NRC staff moved these requirements from 
Section 5 of the proposed rules to Section 4 of the rules set forth in 
SECY-96-077, in response to NEI's 1995 comment (refer to pp. 46-47 of 
Attachment 1 to SECY-96-077). The Commission has removed those 
requirements from Section IV and has reserved the right to impose these 
operational requirements on applicants and licensees who reference this 
appendix (refer to VI.C of this appendix). The additional applicable 
regulations that are applicable to applicants or licensees who 
reference this appendix are specified in the generic DCD as COL license 
information.
    NEI stated that the proposed additional applicable regulations were 
viewed as penalizing advanced plants for incorporating design features 
that enhance safety and could impact the regulatory threshold for 
currently operating plants. NEI also stated that applicable regulations 
are not needed to permit the NRC to deny an exemption request for a 
design feature that is subject to an applicable regulation. The 
Commission decided not to codify the additional applicable regulations 
that were identified in section 5(c) of the proposed rule. Instead, the 
Commission adopted the following position relative to the proposed 
additional applicable regulations.
    Although it is the Commission's intent in 10 CFR part 52 to promote 
standardization and design stability of power reactor designs, 
standardization and design stability are not exclusive goals. The 
Commission recognized that there may be special circumstances when it 
would be appropriate for applicants or licensees to depart from the 
referenced certified designs. However, there is a desire of the 
Commission to maintain standardization across a group of reactors of a 
given design. Nevertheless, Part 52 provides for changes to a certified 
design in carefully defined circumstances, and one of these 
circumstances is the option provided to applicants and licensees 
referencing certified designs to request an exemption from one or more 
elements of the certified design, e.g., 10 CFR 52.63(b)(1). The final 
design certification rule references this provision for Tier 1 and 
includes a similar provision for Tier 2. The criteria for NRC review of 
requests for an exemption from Tier 1 and Tier 2 in the final rule are 
the same as those for NRC review of rule exemption requests under 10 
CFR part 50 directed at non-certified designs, except that the final 
rule requires consideration of an additional factor for Tier 1 
exemptions--whether special circumstances outweigh any decrease in 
safety that may result from the reduction in standardization caused by 
the exemption. It has been the practice of the Commission to require 
that there be no significant decrease in the level of safety provided 
by the regulations when exemptions from the regulations in Part 50 are 
requested. The Commission believes that a similar practice should be 
followed when exemptions from one or more elements of a certified 
design are requested, that is, the granting of an exemption under 10 
CFR 50.12 or 52.63(b)(1) should not result in any significant decrease 
in the level of safety provided by the design (Tier 1 and Tier 2). The 
exemption standards in sections VIII.A.4 and VIII.B.4 of the final rule 
have been modified from the proposed rule to codify this practice.
    In adopting this policy the Commission recognizes that the System 
80+ design not only meets the Commission's safety goals for internal 
events, but also offers a substantial overall enhancement in safety as 
compared, generally, with the current generation of operating power 
reactors. See, e.g., NUREG-1462 at Section 19.1. The Commission 
recognizes that the safety enhancement is the result of many elements 
of the design, and that much but not all of it is reflected in the 
results of the probabilistic risk assessment (PRA) performed and 
documented for them. In adopting a rule that the safety enhancement 
should not be eroded significantly by exemption requests, the 
Commission recognizes and expects that this will require both careful 
analysis and sound judgment, especially considering uncertainties in 
the PRA and the lack of a precise, quantified definition of the 
enhancement which would be used as the standard. Also, in some cases 
scientific proof that a safety margin has or has not been eroded may be 
difficult or even impossible. For this reason, it is appropriate to 
express the Commission's policy preference regarding the grant of 
exemptions in the form of a qualitative, risk informed standard, in 
section VIII of the final rule, and inappropriate to express the policy 
in a quantitative legal standard as part of the additional applicable 
regulations.
    There are three other circumstances where the enhanced safety 
associated with the System 80+ design could be eroded: By design 
changes introduced by ABB-CE at the certification renewal stage; by 
operational experience or other new information suggesting that safety 
margins believed to be achieved are not in fact present; and by 
applicant or licensee design changes under section VIII.B.5 of the 
final rule (for changes to Tier 2 only). In the first two cases Part 52 
limits NRC's ability to require that the safety enhancement be 
restored, unless a question of adequate protection or compliance would 
be presented or, in the case of renewals, unless the restoration offers 
cost-justified, substantive additional protection. Thus, unlike the 
case of exemptions where a policy of maintaining enhanced safety can be 
enforced consistent with the basic structure of Part 52, in the case of 
renewals and new information, implementation of such a policy over 
industry objections would require changes to the basic structure of 
Part 52. The Commission has been and still is unwilling to make 
fundamental changes to Part 52 because this would introduce great 
uncertainty and defeat industry's reasonable expectation of a stable 
regulatory framework. Nevertheless, the Commission on its part also has 
a reasonable expectation that vendors and utilities will cooperate with 
the Commission in assuring that the level of enhanced safety believed 
to be achieved with this design will be reasonably maintained for the 
period of the certification (including renewal).
    This expectation that industry will cooperate with NRC in 
maintaining the safety level of the certified designs applies to design 
changes suggested by new information, to renewals, and to changes under 
section VIII.B.5 of the final rule. If this reasonable expectation is 
not realized, the Commission would carefully review the underlying 
reasons and, if the circumstances were sufficiently persuasive, 
consider the need to reexamine the backfitting and renewal standards in 
Part 52 and the criteria for Tier 2 changes under section VIII.B.5. At 
this time there is no reason

[[Page 27850]]

to believe that cooperation will not be forthcoming and, therefore, no 
reason to change the regulations. With this belief and stated 
Commission policy (and the exemption standard discussed above), there 
is no need for the proposed additional applicable regulations to be 
embedded in the final rule because the objective of the additional 
applicable regulations--maintaining the enhanced level of safety--
should be achieved without them.

B. Responses to Specific Requests for Comment From Proposed Rule

    Only two commenters addressed the specific requests for comments 
that were set forth in section IV of the SOC for the proposed rule. 
These commenters were NEI and the Ohio Citizens for Responsible Energy, 
Inc. (OCRE). The following discussion provides a summary of the 
comments and the Commission's response.
1. Should the Requirements of 10 CFR 52.63(c) be Added to a New 10 CFR 
52.79(e)?
    Comment Summary. OCRE agreed that the requirements of 10 CFR 
52.63(c) should be added to a new 10 CFR 52.79(e) and NEI had no 
objection, as long as the substantive requirements in Sec. 52.63(c) 
were not changed.
    Response. Because there is no objection to adding the requirements 
of 10 CFR 52.63(c) to Subpart C of part 52, as 10 CFR 52.79(e), the 
Commission will consider this amendment as part of a future review of 
Part 52. This future review will also consider lessons learned from 
this rulemaking and will determine if 10 CFR 52.63(c) should be deleted 
from Subpart B of Part 52.
2. Are There Other Words or Phrases That Should Be Defined in Section 2 
of the Proposed Rule?
    Comment Summary. Neither NEI nor OCRE suggested other words or 
phrases that need to be added to the definition section. However, NEI 
recommended expanded definitions for specific terms in Section 2 of the 
proposed rule.
    Response. The Commission has revised Section II of this appendix as 
a result of comments from NEI and DOE. A discussion of these changes is 
provided in sections II.C.2 and II.C.3 of this SOC.
3. What Change Process Should Apply to Design-Related Information 
Developed by a Combined License (COL) Applicant or Holder That 
References This Design Certification Rule?
    Comment Summary. OCRE recommended the change process in Section 
8(b)(5)(i) of the proposed rule and stated that it is essential that 
any design-related COL information including the plant-specific PRA 
(and changes thereto) developed by the COL applicant or holder not have 
issue preclusion and be subject to litigation in any COL hearing. NEI 
recommended that the COL information be controlled by 10 CFR 50.54 and 
50.59 but recognized that the COL applicant or holder must also 
consider impacts on Tier 1 and Tier 2 information. Subsequently, in its 
comments dated July 23, 1996, NEI requested the Commission to modify 
the response to this question that was set forth in SECY-96-077. 
Specifically, NEI stated that plant-specific changes should be 
implemented under Sec. 50.59 or Sec. 50.90, as appropriate. The 
Commission did not significantly modify its former response because the 
change process must consider the effect on information in the DCD, as 
NEI previously acknowledged.
    Response. The Commission will develop a change process for the 
plant-specific information submitted in a COL application that 
references this appendix as part of a future review of Part 52. The 
Commission expects that the change process for the plant-specific 
portion of the COL application will be similar to VIII.B.5 of this 
appendix. This approach is generally consistent with the 
recommendations of OCRE and NEI.
    The Commission agrees with OCRE that the plant-specific portion of 
the COL application will not have issue preclusion in the licensing 
hearing. A discussion of the information that will have issue 
preclusion is provided in sections II.A.1 and III.F of this SOC.
4. Are Each of the Applicable Regulations Set Forth in Section 5(c) of 
the Proposed Rule Justified?
    Comment Summary. OCRE found each of the applicable regulations to 
be justified and stated that these requirements are responsive to 
issues arising from operating experience and will greatly reduce the 
risk of severe accidents for plants using these standard designs. NEI 
believes that none of the applicable regulations are justified and 
stated that they are legally and technically unnecessary, could give 
rise to unwarranted backfits, are destabilizing and, therefore, 
contrary to the purpose of 10 CFR part 52.
    Response. The Commission has determined that it is not necessary to 
codify the new applicable regulations, as explained in section II.A.3 
of this SOC.
5. Section 8(b)(5)(i) of the Proposed Rule 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?
    Comment Summary. OCRE believes that the process for plant-specific 
departures from Tier 2, as well as the substantive aspect of the change 
itself, should be open to challenge, although OCRE believes that the 
second aspect is the more important. By contrast, NEI argued that 
neither the departure process nor the change should be subject to 
litigation in any licensing hearing. Rather, NEI argued that any person 
who wished to challenge the change should raise the matter in a 
petition for an enforcement action under 10 CFR 2.206.
    Response. The Commission has determined that an interested person 
should be provided the opportunity to challenge, in an appropriate 
licensing proceeding, whether the applicant or licensee properly 
complied with the Tier 2 departure process. Therefore, VIII.B.5 of this 
appendix has been modified to include a provision for challenging Tier 
2 departures. The scope of finality for plant-specific departures is 
discussed in greater detail in section II.A.1 of this SOC.
6. How Should the Determinations Made by an Applicant or Licensee That 
Changes May Be Made Under Section 8(b)(5)(i) of the Proposed Rule, 
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?
    Comment Summary. OCRE recommends that the determinations and 
descriptions of the changes be set forth in the COL application and 
that they should be submitted to the NRC

[[Page 27851]]

after COL issuance. Any person wishing to challenge the determinations 
or changes should file a petition pursuant to 10 CFR 2.206. NEI 
recommends submitting periodic reports that summarize departures made 
under Section 8(b)(5) to the NRC pursuant to Section 9(b) of the 
proposed design certification rules, consistent with the existing 
process for NRC notifications by licensees under 10 CFR 50.59. These 
reports will be available in the NRC's Public Document Room.
    Response. The Tier 2 departure process in Section 8(b)(5) and the 
respective reporting requirements in Section 9(b) of the proposed 
design certification rule (VIII.B.5 and X.B of this appendix) were 
based on 10 CFR 50.59. It therefore seems reasonable that the 
information collection and reporting requirements that should be used 
to control Tier 2 departures made in accordance with VIII.B.5 of this 
appendix should generally follow the regulatory scheme in 10 CFR 50.59 
(except that the requirements should also be applied to COL 
applicants), absent countervailing considerations unique to the design 
certification and combined license regulatory scheme in Part 52. OCRE's 
proposal raises policy considerations which are not unique to this 
design certification, but are equally applicable to the Part 50 
licensing scheme. In fact, OCRE has submitted a petition (see 59 FR 
30308; June 13, 1994) which raises the generic matter of public access 
to licensee-held information. In view of the generic nature of OCRE's 
concern and the pendency of OCRE's petition, which independently raises 
this matter, the Commission concludes that this rulemaking should not 
address this matter.
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?
    Comment Summary. OCRE recommends either an amendment to the license 
application or an amendment to the license, with the requisite hearing 
rights. NEI recommends NRC approval by letter with an opportunity for 
public hearing only for those Tier 2* changes that also involve either 
a change in Tier 1 or technical specifications, or an unreviewed safety 
question.
    Response. The Commission has developed a change process for Tier 2* 
information, as described in sections II.A.2 and III.H of this SOC, 
which essentially treats the proposed departure as a request for a 
license amendment with an opportunity for hearing. Since Tier 2* 
departures require NRC review and approval, and involve a licensee 
departing from the requirements of this appendix, the Commission 
regards such requests for departures as analogous to license 
amendments. Accordingly, VIII.B.6 of this appendix specifies that such 
requests will be treated as requests for license amendments after the 
license is issued, and that the Tier 2* departure shall not be 
considered to be matters resolved by this rulemaking prior to a license 
being issued.
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?
    Comment Summary. OCRE supports the concept behind the criteria in 
the proposed rule for determining if a proposed change to severe 
accident issues constitutes an unreviewed safety question, but proposes 
changes to the criteria. NEI agrees with the criteria in the proposed 
rule but recommends an expansion of the scope of information that would 
come under the special criteria for determining an unreviewed safety 
question.
    Response. The Commission disagrees with the recommendations of both 
NEI and OCRE. The Commission has decided to retain the special change 
process for severe accident information, as described in sections 
II.A.2 and III.H of this SOC.
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?
    (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?
    (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?
    (2) What should be the legal consequences, from the standpoints of 
issue resolution in the operating license proceeding, NRC enforcement, 
and licensee operation if a design certification rule is referenced by 
an applicant for an operating license under 10 CFR Part 50?
    (c) Is it necessary to resolve these issues as part of this design 
certification, or may resolution of these issues be deferred without 
adverse consequence (e.g., without foreclosing alternatives for future 
resolution).
    Comment Summary. OCRE proposed that a construction permit applicant 
should be allowed to reference design certifications and that the 
applicant be required to reference ITAAC because they are Tier 1. OCRE 
indicated that in a construction permit hearing, those issues 
representing a challenge to the design certification rule would be 
prohibited pursuant to 10 CFR 2.758. At the operating license stage, 
only an applicant whose construction permit referenced a design 
certification rule should be allowed to reference the design 
certification. In the operating license hearing, issues would be 
limited to whether the ITAAC have been met. Requiring a construction 
permit applicant to reference the ITAAC would not be the same as a 
combined license applicant under 10 CFR part 52, in OCRE's view, 
apparently because the specific hearing provisions of 10 CFR 52.103 
would not be employed. Finally, OCRE argued that resolution of these 
issues could be safely deferred because the circumstances with which 
these issues attend are not likely to be faced.
    NEI also argued that a construction permit applicant should be 
allowed to reference design certifications. However, NEI believed that 
the applicant should be permitted, but not required, to reference the 
ITAAC. If the applicant did not reference the ITAAC, then 
``construction-related issues'' would be subject to both NRC review and 
an opportunity for hearing at the operating license stage in the same 
manner as construction-related issues in

[[Page 27852]]

current Part 50 operating license proceedings. NEI reiterated its view 
that design certification issues should be considered resolved in all 
subsequent NRC proceedings. With respect to deferring a Commission 
decision on the matter, NEI suggested that these issues be resolved now 
because the industry wishes to ``reinforce'' the permissibility of 
using a design certification in a Part 50 proceeding. Further, NEI 
argues that deletion of all mention of construction permits and 
operating licenses in the design certification rule could be construed 
as indicating the Commission's desire to preclude a construction permit 
or operating license applicant from referencing a design certification.
    Response. Although 10 CFR Part 52 provides for referencing of 
design certification rules in Part 50 applications and licenses, the 
Commission wishes to reserve for future consideration the manner in 
which a Part 50 applicant could be permitted to reference this design 
certification and whether it should be permitted or required to 
reference the ITAAC. This decision is due to the manner in which ITAAC 
were developed for this appendix and recognition of the lack of 
experience with design certifications in combined licenses, in 
particular the implementation of ITAAC. Therefore, the Commission has 
decided that it is appropriate for the final rule to have some 
uncertainty regarding the manner in which this appendix could be 
referenced in a Part 50 proceeding, as set forth in Section IV.B of 
this appendix.

C. Other Issues

1. NRC Verification of ITAAC Determinations
    Comment Summary. In Attachment B of its comments dated August 4, 
1995 (pp. 58-66), NEI raised an industry concern regarding the matters 
to be considered by the NRC in verifying inspections, tests, analyses, 
and acceptance criteria (ITAAC) determinations pursuant to 10 CFR 
52.99, specifically citing quality assurance and quality control (QA/
QC) deficiencies. Although this issue was not specifically addressed in 
the proposed rule, the following response is provided because of its 
importance relative to future considerations of the successful 
performance of ITAAC for a nuclear power facility. Subsequently, in its 
comments dated July 23, 1996, NEI requested the Commission to delete 
significant portions of the NRC's response, which was originally set 
forth in SECY-96-077 (refer to pages 33-36 of Attachment 1).
    Response. The Commission decided to delete the responses in SECY-
96-077 on licensee documentation of ITAAC verification; NRC inspection; 
and facility ITAAC verification; because they do not directly relate to 
the design certification rulemakings. However, the NRC disagrees with 
NEI's assertion that QA/QC deficiencies have no relevance to the NRC 
determination of whether ITAAC have been successfully completed. Simply 
confirming that an ITAAC had been performed in some manner and a result 
obtained apparently showing that the acceptance criteria had been met 
would not be sufficient to support a determination that the ITAAC had 
been successfully completed. The manner in which an ITAAC is performed 
can be relevant and material to the results of the ITAAC. For example, 
in conducting an ITAAC to verify a pump's flow rate, it is logical, 
even if not explicitly specified in the ITAAC, that the gauge used to 
verify the pump flow rate must be calibrated in accordance with 
relevant QA/QC requirements and that the test configuration is 
representative of the final as-built plant conditions (i.e. valve or 
system line-ups, gauge locations, system pressures or temperatures). 
Otherwise, the acceptance criteria for pump flow rate in the ITAAC 
could apparently be met while the actual flow rate in the system could 
be much less than that required by the approved design.
    The NRC has determined that a QA/QC deficiency may be considered in 
determining whether an ITAAC has been successfully completed if: (1) 
The QA/QC deficiency is directly and materially related to one or more 
aspects of the relevant ITAAC (or supporting Tier 2 information); and 
(2) the deficiency (considered by itself, with other deficiencies, or 
with other information known to the NRC) leads the NRC to question 
whether there is a reasonable basis for concluding that the relevant 
aspect of the ITAAC has been successfully completed. This approach is 
consistent with the NRC's current methods for verifying initial test 
programs. The NRC recognizes that there may be programmatic QA/QC 
deficiencies that are not relevant to one or more aspects of a given 
ITAAC under review and, therefore, should not be relevant to or 
considered in the NRC's determination as to whether an ITAAC has been 
successfully completed. Similarly, individual QA/QC deficiencies 
unrelated to an aspect of the ITAAC in question would not form the 
basis for an NRC determination that an ITAAC has not been met. Using 
the ITAAC for pump flow rate example, a specific QA deficiency in the 
calibration of pump gauges would not preclude an NRC determination of 
successful ITAAC completion if the licensee could demonstrate that the 
original deficiency was properly corrected (e.g., analysis, scope of 
effect, root cause determination, and corrective actions as 
appropriate), or that the deficiency could not have materially affected 
the test in question.
    Furthermore, although Tier 1 information was developed to focus on 
the performance of the structures, systems, and components of the 
design, the information contains implicit quality standards. For 
example, the design descriptions for reactor and fluid systems describe 
which systems are ``safety-related;'' important piping systems are 
classified as ``Seismic Category I'' and identify the ASME Code Class; 
and important electrical and instrumentation and control systems are 
classified as ``Class 1E.'' The use of these terms by the evolutionary 
plant designers was meant to ensure that the systems would be built and 
maintained to the appropriate standards. Quality assurance deficiencies 
for these systems would be assessed for their impact on the performance 
of the ITAAC, based on their safety significance to the system. The QA 
requirements of 10 CFR Part 50, Appendix B, apply to safety-related 
activities. Therefore, the Commission anticipates that, because of the 
special significance of ITAAC related to verification of the facility, 
the licensee will implement similar QA processes for ITAAC activities 
that are not safety-related.
    During the ITAAC development, the design certification applicants 
determined that it was impossible (or extremely burdensome) to provide 
all details relevant to verifying all aspects of ITAAC (e.g., QA/QC) in 
Tier 1 or Tier 2. Therefore, the NRC staff accepted the applicants' 
proposal that top-level design information be stated in the ITAAC to 
ensure that it was verified, with an emphasis on verification of the 
design and construction details in the ``as-built'' facility. To argue 
that consideration of underlying information which is relevant and 
material to determining whether ITAAC have been successfully completed, 
ignores the history of ITAAC development. In summary, the Commission 
concludes that information such as QA/QC deficiencies which are 
relevant and material to ITAAC may be considered by the NRC in 
determining whether the ITAAC have been successfully completed. Despite 
this conclusion, the

[[Page 27853]]

Commission has decided to add a provision to this appendix (IX.B.1), 
which was requested by NEI. This provision requires the NRC's findings 
(that the prescribed acceptance criteria have been met) to be based 
solely on the inspections, tests, and analyses. The Commission has 
added this provision, which is fully consistent with 10 CFR Part 52, 
with the understanding that it does not affect the manner in which the 
NRC intends to implement 10 CFR 52.99 and 52.103(g), as described 
above.
2. DCD Introduction
    Comment Summary. The proposed rule incorporated Tier 1 and Tier 2 
information into the DCD but did not include the introduction to the 
DCD. The SOC for the proposed rule indicated that this was a deliberate 
decision, stating:

    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.

Both the applicant and NEI took strong exception to this statement. 
They both argued that the language of the DCD introduction was the 
subject of careful discussion and negotiation between the NRC staff, 
NRC's Office of the General Counsel, and representatives of the 
applicant and NEI. They, therefore, suggested that the definition of 
the DCD in Section 2(a) of the proposed rule be amended to explicitly 
include the DCD Introduction and that Section 4(a) of the proposed rule 
be amended to generally require that applicants or licensees comply 
with the entire DCD. However, in the event that the Commission rejected 
their suggestion, NEI alternatively argued that the substantive 
provisions of the DCD Introduction be directly incorporated into the 
design certification rule's language (refer to NEI Comments dated 
August 4, 1995, Attachment B, pp. 90-108, and July 23, 1996, pp. 43-49; 
ABB-CE Comments, Attachment A).
    Response. The DCD Introduction was created to be a convenient 
explanation of some provisions of the design certification rule and was 
not intended to become rule language itself. Therefore, the Commission 
declines the suggestion to incorporate the DCD introduction, but 
adopted NEI's alternative suggestion of incorporating substantive 
procedural and administrative requirements into the design 
certification rule. It is the Commission's view that the procedural and 
administrative provisions described in the DCD Introduction should be 
included in, and be an integrated part of, the design certification 
rule. As a result, Sections II, III, IV, VI, VIII, and X of this 
appendix have been revised and Section IX was created to adopt 
appropriate provisions from the DCD Introduction. In some cases, the 
wording of these provisions has been modified, as appropriate, to 
achieve clarity or to conform with the final design certification rule 
language.
    In section C.2 of its comments, dated August 4, 1995, ABB-CE stated 
that all tables within Section 19.7, ``External Events Analysis,'' of 
the System 80+ DCD should be deleted. ABB-CE stated that the 
probabilistic numerical results in these tables were included in its 
DCD as a result of a printing error. The Commission decided that the 
deletion of these tables from Section 19.7 of the DCD is acceptable 
because a site-specific version of this information will be created by 
an applicant that references this appendix.
3. Duplicate Documentation in Design Certification Rule
    Comment Summary. On page 4 of its comments, dated August 7, 1995, 
the Department of Energy (DOE) recommended that the process for 
preparing the design certification rule be simplified by eliminating 
the DCD, which DOE claims is essentially a repetition of the Standard 
Safety Analysis Report (SSAR). DOE's concern, which was further 
clarified during a public meeting on December 4, 1995, is that the NRC 
will require separate copies of the DCD and SSAR to be maintained. 
During the public meeting, DOE also expressed a concern that 
Sec. 52.79(b) could be confusing to an applicant for a combined license 
because it currently states: ``The final safety analysis report and 
other required information may incorporate by reference the final 
safety analysis report for a certified standard design.''
    Response. The NRC does not require duplicate documentation for this 
design certification rule. The DCD is the only document that is 
incorporated by reference into this appendix in order to meet the 
requirements of Subpart B of Part 52. The SSAR supports the final 
design approval (FDA) that was issued under Appendix O to 10 CFR Part 
52. The DCD was developed to meet the requirements for incorporation by 
reference and to conform with requests from the industry such as 
deletion of the quantitative portions of the design-specific 
probabilistic risk assessment. Because the DCD terminology was not 
envisioned at the time that Part 52 was developed, the Commission will 
consider modifying Sec. 52.79(b), as part of its future review of Part 
52, in order to clarify the use of the term ``final safety analysis 
report.'' In the records and reporting requirements in Section X of 
this appendix, additional terms were used to distinguish between the 
documents to be maintained by the applicant for this design 
certification rule and the document to be maintained by an applicant or 
licensee who references this appendix. These new terms are defined in 
Section II of this appendix and further described in the section-by-
section discussion on records and reporting in section III.J of this 
SOC. The applicant chose to continue to reference the SSAR as the 
supporting document for its FDA. As a result, the applicant must 
maintain the SSAR for the duration of the FDA.

III. Section-by-Section Discussion

A. Introduction

    The purpose of Section I of Appendix B to 10 CFR Part 52 (``this 
appendix'') is to identify the standard plant design that is approved 
by this design certification rule and the applicant for certification 
of the standard design. Identification of the design certification 
applicant is necessary to implement this appendix, for two reasons. 
First, the implementation of 10 CFR 52.63(c) depends on whether an 
applicant for a combined license (COL) contracts with the design 
certification applicant to provide the generic DCD and supporting 
design information. If the COL applicant does not use the design 
certification applicant to provide this information, then the COL 
applicant must meet the requirements in 10 CFR 52.63(c). Also, X.A.1 of 
this appendix imposes a requirement on the design certification 
applicant to maintain the generic DCD throughout the time period in 
which this appendix may be referenced.

B. Definitions

    The terms Tier 1, Tier 2, Tier 2*, and COL action items (license 
information) are defined in this appendix because these concepts were 
not envisioned when 10 CFR Part 52 was developed. The design 
certification applicants and the NRC staff used these terms in 
implementing the two-tiered rule structure that was proposed by 
industry after the issuance of 10 CFR Part 52. ABB-CE used the terms 
``certified design material'' and ``approved design material'' for Tier 
1 and Tier 2

[[Page 27854]]

information, respectively, in the System 80+ DCD. During consideration 
of the comments received on the proposed rule, the Commission 
determined that it would be useful to distinguish between the ``plant-
specific DCD'' and the ``generic DCD,'' the latter of which is 
incorporated by reference into this appendix and remains unaffected by 
plant-specific departures. This distinction is necessary in order to 
clarify the obligations of applicants and licensees that reference this 
appendix. Also, the technical specifications that are located in 
Chapter 16 of the generic DCD were designated as ``generic technical 
specifications'' to facilitate the special treatment of this 
information in the final rule (refer to section II.A.1 of this SOC). 
Therefore, appropriate definitions for these additional terms are 
included in the final rule.
    The Tier 1 portion of the design-related information contained in 
the DCD is certified by this appendix and, therefore, subject to the 
special backfit provisions in VIII.A of this appendix. An applicant who 
references this appendix is required to incorporate by reference and 
comply with Tier 1, under III.B and IV.A.1 of this appendix. This 
information consists of an introduction to Tier 1, the design 
descriptions and corresponding ITAAC for systems and structures of the 
design, design material applicable to multiple systems of the design, 
significant interface requirements, and significant site parameters for 
the design. The design descriptions, interface requirements, and site 
parameters in Tier 1 were derived entirely from Tier 2, but may be more 
general than the Tier 2 information. 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. Changes to or 
departures from the Tier 1 information must comply with VIII.A of this 
appendix.
    The Tier 1 design descriptions serve as design commitments for the 
lifetime of a facility referencing the design certification. 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 licensees or for renewal of the COL. However, subsequent 
modifications to the facility must comply with the design descriptions 
in the plant-specific DCD unless changes are made in accordance with 
the change process in Section VIII of this appendix. The Tier 1 
interface requirements are the most significant of the interface 
requirements for systems that are wholly or partially outside the scope 
of the standard design, which were submitted in response to 10 CFR 
52.47(a)(1)(vii) and must be met by the site-specific design features 
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). An application that 
references this appendix must demonstrate that the site parameters 
(both Tier 1 and Tier 2) are met at the proposed site (refer to 
discussion in III.D of this SOC).
    Tier 2 is the portion of the design-related information contained 
in the DCD that is approved by this appendix but is not certified. Tier 
2 information is subject to the backfit provisions in VIII.B of this 
appendix. Tier 2 includes the information required by 10 CFR 52.47, 
with the exception of generic technical specifications and conceptual 
design information, 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. As with Tier 1, III.B 
and IV.A.1 of this appendix require an applicant who references this 
appendix to incorporate Tier 2 by reference and to comply with Tier 2 
(except for the COL action items and conceptual design information). 
The definition of Tier 2 makes clear that Tier 2 information has been 
determined by the Commission, by virtue of its inclusion in this 
appendix and its designation as Tier 2 information, to be an approved 
(``sufficient'') method for meeting Tier 1 requirements. However, there 
may be other acceptable ways of complying with Tier 1. The appropriate 
criteria for departing from Tier 2 information are set forth in Section 
VIII of this appendix. Departures from Tier 2 do not negate the 
requirement in Section III.B to reference Tier 2. NEI requested the 
Commission, in its comments dated July 23, 1996, to include several 
statements on compliance with Tier 2 in the definitions of Tier 1 and 
Tier 2. The Commission determined that inclusion of those statements in 
the Tier 2 definition was appropriate, but to also include them in the 
Tier 1 definition would be unnecessarily redundant.
    Certain Tier 2 information has been designated in the generic DCD 
with brackets and italicized text as ``Tier 2*'' information and, as 
discussed in greater detail in the section-by-section explanation for 
Section VIII, a plant-specific departure from Tier 2* information 
requires prior NRC approval. However, the Tier 2* designation expires 
for some of this information when the facility first achieves full 
power after the finding required by 10 CFR 52.103(g). The process for 
changing Tier 2* information and the time at which its status as Tier 
2* expires is set forth in VIII.B.6 of this appendix.
    A definition of ``combined license (COL) action items'' (COL 
license information) has been added to clarify that COL applicants are 
required to address these matters in their license application, but the 
COL action items are not the only acceptable set of information. An 
applicant may depart from or omit these items, provided that the 
departure or omission is identified and justified in the FSAR. After 
issuance of a construction permit or COL, these items are not 
requirements for the licensee unless such items are restated in its 
FSAR.
    In developing the proposed design certification rule, the 
Commission contemplated that there would be both generic (master) DCDs 
maintained by the NRC and the design certification applicant, as well 
as individual plant-specific DCDs, maintained by each applicant and 
licensee who references this design certification rule. The generic 
DCDs (identical to each other) would reflect generic changes to the 
version of the DCD approved in this design certification rulemaking. 
The generic changes would occur as the result of generic rulemaking by 
the Commission (subject to the change criteria in Section VIII of this 
appendix). In addition, the Commission understood that each applicant 
and licensee referencing this Appendix would be required to submit and 
maintain a plant-specific DCD. This plant-specific DCD would contain 
(not just incorporate by reference) the information in the generic DCD. 
The plant-specific DCD would be updated as necessary to reflect the 
generic changes to the DCD that the Commission may adopt through 
rulemaking, any plant-specific departures from the generic DCD that the 
Commission imposed on the licensee by order, and any plant-specific 
departures that the licensee chose to make in accordance with the 
relevant processes in Section VIII of this appendix. Thus, the plant-
specific DCD would function akin to an updated Final Safety Analysis 
Report, in the since that it would provide the most complete and 
accurate information on a plant's licensing basis for that part of the 
plant within the scope of this appendix. However, the proposed rule 
defined

[[Page 27855]]

only the concept of the ``master'' DCD. The Commission continues to 
believe that there should be both a generic DCD and plant-specific 
DCDs. To clarify this matter, the proposed rule's definition of DCD has 
been redesignated as the ``generic DCD,'' a new definition of ``plant-
specific DCD'' has been added, and conforming changes have been made to 
the remainder of the rule. Further information on exemptions or 
departures from information in the DCD is provided in section III.H 
below. The Final Safety Analysis Report (FSAR) that is required by 
Sec. 52.79(b) will consist of the plant-specific DCD, the site-specific 
portion of the FSAR, and the plant-specific technical specifications.
    During the resolution of comments on the final rules in SECY-96-
077, the Commission decided to treat the technical specifications in 
Chapter 16 of the DCD as a special category of information and to 
designate them as generic technical specifications (refer to II.A.1 of 
SOC). A COL applicant must submit plant-specific technical 
specifications that consist of the generic technical specifications, 
which may be modified under Section VIII.C of this appendix, and the 
remaining plant-specific information needed to complete the technical 
specifications, including bracketed values.

C. Scope and Contents

    The purpose of Section III of this appendix is to describe and 
define the scope and contents of this design certification and to set 
forth how documentation discrepancies or inconsistencies are to be 
resolved. Paragraph A is the required statement of the Office of the 
Federal Register (OFR) for approval of the incorporation by reference 
of Tier 1, Tier 2, and the generic technical specifications into this 
appendix and paragraph B requires COL applicants and licensees to 
comply with the requirements of this appendix. 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. Tier 1 and 
Tier 2 information, as well as the generic technical specifications 
have been combined into a single document, called the generic design 
control document (DCD), in order to effectively control this 
information and facilitate its incorporation by reference into the 
rule. The generic DCD was prepared to meet the requirements of the OFR 
for incorporation by reference (1 CFR Part 51). One of the requirements 
of OFR for incorporation by reference is that the design certification 
applicant must make the DCD available upon request after the final rule 
becomes effective. The applicant requested the National Technical 
Information Service (NTIS) to distribute the generic DCD for them. 
Therefore, paragraph A states that copies of the DCD can be obtained 
from NTIS, 5285 Port Royal Road, Springfield, VA 22161. The NTIS order 
numbers for paper or CD-ROM copies of the System 80+ DCD are PB97-
147854 or PB97-502108, respectively.
    The generic DCD (master copy) 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 available at the NRC's Public Document 
Room. Questions concerning the accuracy of information in an 
application that references this appendix will be resolved by checking 
the generic DCD in NRC's central file. If a generic change (rulemaking) 
is made to the DCD pursuant to the change process in Section VIII of 
this appendix, then at the completion of the rulemaking the NRC will 
request approval of the Director, OFR for the changed incorporation by 
reference and change its copies of the generic DCD and notify the OFR 
and the design certification applicant to change their copies. The 
Commission is requiring that the design certification applicant 
maintain an up-to-date copy under X.A.1 of this appendix because it is 
likely that most applicants intending to reference the standard design 
will obtain the generic DCD from the design certification applicant. 
Plant-specific changes to and departures from the generic DCD will be 
maintained by the applicant or licensee that references this appendix 
in a plant-specific DCD, under X.A.2 of this appendix.
    In addition to requiring compliance with this appendix, paragraph B 
clarifies that the conceptual design information and the ``Technical 
Support Document'' are not considered to be part of this appendix. The 
conceptual design information is for those portions of the plant that 
are outside the scope of the standard design and are intermingled 
throughout Tier 2. As provided by 10 CFR 52.47(a)(1)(ix), these 
conceptual designs are not part of this appendix and, therefore, are 
not applicable to an application that references this appendix. 
Therefore, the applicant does not need to conform with the conceptual 
design information that was provided by the design certification 
applicant. The conceptual design information, which consists of site-
specific design features, was required to facilitate the design 
certification review. Conceptual design information is neither Tier 1 
nor Tier 2. The introduction to Tier 2 identifies the location of the 
conceptual design information. The Technical Support Document provides 
ABB-CE's evaluation of various design alternatives to prevent and 
mitigate severe accidents, and does not constitute design requirements. 
The Commission's assessment of this information is discussed in section 
IV of this SOC on environmental impacts. The detailed methodology and 
quantitative portions of the design-specific probabilistic risk 
assessment (PRA), as required by 10 CFR 52.47(a)(1)(v), were not 
included in the DCD, as requested by NEI and the applicant for design 
certification. The NRC agreed with the request to delete this 
information because conformance with the deleted portions of the PRA is 
not necessary. Also, the NRC's position is predicated in part upon 
NEI's acceptance, in conceptual form, of a future generic rulemaking 
that will require a COL applicant or licensee to have a plant-specific 
PRA that updates and supersedes the design-specific PRA supporting this 
rulemaking and maintain it throughout the operational life of the 
facility.
    Paragraphs C and D set forth the manner in which potential 
conflicts are to be resolved. Paragraph C establishes the Tier 1 
description in the DCD as controlling in the event of an inconsistency 
between the Tier 1 and Tier 2 information in the DCD. Paragraph D 
establishes the generic DCD as the controlling document in the event of 
an inconsistency between the DCD and either the application for 
certification of the standard design, referred to as the Standard 
Safety Analysis Report, or the final safety evaluation report for the 
certified design and its supplement.
    Paragraph E makes it clear that design activities that are wholly 
outside the scope of this design certification may be performed using 
site-specific design parameters, provided the design activities do not 
affect Tier 1 or Tier 2, or conflict with the interface requirements in 
the DCD. This provision applies to site-specific portions of the plant, 
such as the service water intake structure. NEI requested insertion of 
this clarification into the final rule (refer to its comments on the 
Tier 1 definition dated July 23, 1996). Because this statement is not a 
definition, the Commission decided that the appropriate location is in 
Section III of the final rule.

[[Page 27856]]

D. Additional Requirements and Restrictions.

    Section IV of this appendix sets forth additional requirements and 
restrictions imposed upon an applicant who references this appendix. 
Paragraph IV.A sets forth the information requirements for these 
applicants. This appendix distinguishes between information and/or 
documents which must actually be included in the application or the 
DCD, versus those which may be incorporated by reference (i.e., 
referenced in the application as if the information or documents were 
actually included in the application), thereby reducing the physical 
bulk of the application. Any incorporation by reference in the 
application should be clear and should specify the title, date, 
edition, or version of a document, and the page number(s) and table(s) 
containing the relevant information to be incorporated by reference.
    Paragraph A.1 requires an applicant who references this appendix to 
incorporate by reference this appendix in its application. The legal 
effect of such incorporation by reference is that this appendix is 
legally binding on the applicant or licensee. Paragraph A.2.a is 
intended to make clear that the initial application must include a 
plant-specific DCD. This assures, among other things, that the 
applicant commits to complying with the DCD. This paragraph also 
requires the plant-specific DCD to use the same format as the generic 
DCD and to reflect the applicant's proposed departures and exemptions 
from the generic DCD as of the time of submission of the application. 
The Commission expects that the plant-specific DCD will become the 
plant's final safety analysis report (FSAR), by including within its 
pages, at the appropriate points, information such as site-specific 
information for the portions of the plant outside the scope of the 
referenced design, including related ITAAC, and other matters required 
to be included in an FSAR by 10 CFR 50.34. Integration of the plant-
specific DCD and remaining site-specific information into the plant's 
FSAR, will result in an application that is easier to use and should 
minimize ``duplicate documentation'' and the attendant possibility for 
confusion (refer to sections II.C.3 and III.J of this SOC). Paragraph 
A.2.a is also intended to make clear that the initial application must 
include the reports on departures and exemptions as of the time of 
submission of the application.
    Paragraph A.2.b requires that the application include the reports 
required by paragraph X.B of this appendix for exemptions and 
departures proposed by the applicant as of the date of submission of 
its application. Paragraph A.2.c requires submission of plant-specific 
technical specifications for the plant that consists of the generic 
technical specifications from Chapter 16 of the DCD, with any changes 
made under Section VIII.C of this appendix, and the technical 
specifications for the site-specific portions of the plant that are 
either partially or wholly outside the scope of this design 
certification, such as the ultimate heat sink. The applicant must also 
provide the plant-specific information designated in the generic 
technical specifications, such as bracketed values. Paragraph A.2.d 
makes it clear that the applicant must provide information 
demonstrating that the proposed site falls within the site parameters 
for this appendix and that the plant-specific design complies with the 
interface requirements, as required by 10 CFR 52.79(b).
    If the proposed site has a characteristic that exceeds one or more 
of the site parameters in the DCD, then the proposed site is 
unacceptable for this design unless the applicant seeks an exemption 
under Section VIII of this appendix and justifies why the certified 
design should be found acceptable on the proposed site. Paragraph A.2.e 
requires submission of information addressing COL Action Items, which 
are identified in the generic DCD as COL License Information, in the 
application. The COL Action Items (COL License Information) identify 
matters that need to be addressed by an applicant that references this 
appendix, as required by Subpart C of 10 CFR Part 52. An applicant may 
depart from or omit these items, provided that the departure or 
omission is identified and justified in its application (FSAR). 
Paragraph A.2.f requires that the application include the information 
required by 10 CFR 52.47(a) that is not within the scope of this rule, 
such as generic issues that must be addressed by an applicant that 
references this rule. Paragraph A.3 requires the applicant to 
physically include, not simply reference, the proprietary information 
referenced in the System 80+ DCD, or its equivalent, to assure that the 
applicant has actual notice of these requirements.
    Paragraph IV.B reserves to the Commission the right to determine in 
what manner this design certification may be referenced by an applicant 
for a construction permit or operating license under 10 CFR Part 50. 
This determination may occur in the context of a subsequent rulemaking 
modifying 10 CFR Part 52 or this design certification rule, or on a 
case-by-case basis in the context of a specific application for a Part 
50 construction permit or operating license. This provision was 
necessary because the evolutionary design certifications were not 
implemented in the manner that was originally envisioned at the time 
that Part 52 was created. The Commission's concern is with the manner 
in which ITAAC were developed and the lack of experience with design 
certifications in license proceedings (refer to section II.B.9 of this 
SOC). Therefore, it is appropriate for the final rule to have some 
uncertainty regarding the manner in which this appendix could be 
referenced in a Part 50 licensing proceeding.

E. Applicable Regulations

    The purpose of Section V of this appendix is to specify the 
regulations that were applicable and in effect at the time that this 
design certification was approved. These regulations consist of the 
technically relevant regulations identified in paragraph A, except for 
the regulations in paragraph B that are not applicable to this 
certified design.
    Paragraph A identifies the regulations in 10 CFR Parts 20, 50, 73, 
and 100 that are applicable to the System 80+ design. After the NRC 
staff completed its FSER for the System 80+ design (August 1994), the 
Commission amended several existing regulations and adopted several new 
regulations in those Parts of Title 10 of the Code of Federal 
Regulations. The Commission has reviewed these regulations to determine 
if they are applicable to this design and, if so, to determine if the 
design meets these regulations. The Commission finds that the System 
80+ design either meets the requirements of these regulations or that 
these regulations are not applicable to the design, as discussed below. 
The Commission's determination of the applicable regulations was made 
as of the date specified in paragraph V.A of this appendix. The 
specified date is the date that this appendix was approved by the 
Commission and signed by the Secretary of the Commission.

10 CFR Part 73, Protection Against Malevolent Use of Vehicles at 
Nuclear Power Plants (59 FR 38889; August 1, 1994)

    The objective of this regulation is to modify the design basis 
threat for radiological sabotage to include use of a land vehicle by 
adversaries for transporting personnel and their hand-carried equipment 
to the proximity of vital areas and to include a land vehicle bomb. 
This regulation also requires reactor licensees to install vehicle

[[Page 27857]]

control measures, including vehicle barrier systems, to protect against 
the malevolent use of a land vehicle. The Commission has determined 
that this regulation will be addressed in the COL applicant's site-
specific security plan. Therefore, no additional actions are required 
for this design.

10 CFR 19 and 20, Radiation Protection Requirements: Amended 
Definitions and Criteria (60 FR 36038; July 13, 1995)

    The objective of this regulation is to revise the radiation 
protection training requirement so that it applies to workers who are 
likely to receive, in a year, an occupational dose in excess of 100 
mrem (1 mSv); revise the definition of the ``Member of the public'' to 
include anyone who is not a worker receiving an occupational dose; 
revise the definition of ``Occupational Dose'' to delete reference to 
location so that the occupational dose limit applies only to workers 
whose assigned duties involve exposure to radiation and not to members 
of the public; revise the definition of the ``Public Dose'' to apply to 
doses received by members of the public from material released by a 
licensee or from any other source of radiation under control of the 
licensee; assure that prior dose is determined for anyone subject to 
the monitoring requirements in 10 CFR Part 20, or in other words, 
anyone likely to receive, in a year, 10 percent of the annual 
occupational dose limit; and retain a requirement that known 
overexposed individuals receive copies of any reports of the exposure 
that are required to be submitted to the NRC. The Commission has 
determined that these requirements will be addressed in the COL 
applicant's operational radiation protection program. Therefore, no 
additional actions are required for this design.

10 CFR 50, Technical Specifications (60 FR 36953; July 19, 1995)

    The objective of this revised regulation is to codify criteria for 
determining the content of technical specification (TS). The four 
criteria were first adopted and discussed in detail in the Final Policy 
Statement on Technical Specification Improvements for Nuclear Power 
Reactors (58 FR 39132; July 22, 1993). The Commission has determined 
that these requirements will be addressed in the COL applicant's 
technical specifications. Therefore, no additional actions are required 
for this design.

10 CFR 73, Changes to Nuclear Power Plant Security Requirements 
Associated With Containment Access Control (60 FR 46497; September 7, 
1995)

    The objective of this revised regulation is to delete certain 
security requirements for controlling the access of personnel and 
materials into reactor containment during periods of high traffic such 
as refueling and major maintenance. This action relieves nuclear power 
plant licensees of requirement to separately control access to reactor 
containments during these periods. The Commission has determined that 
this regulation will be addressed in the COL applicant's site-specific 
security plan. Therefore, no additional actions are required for this 
design.

10 CFR Part 50, Primary Reactor Containment Leakage Testing for Water-
Cooled Power Reactors (60 FR 49495; September 26, 1995)

    The objective of this revised regulation is to provide a 
performance-based option for leakage-rate testing of containments of 
light-water-cooled nuclear power plants. This performance-based option, 
option B to Appendix J, is available for voluntary adoption by 
licensees in lieu of compliance with the prescriptive requirements 
contained in the current regulation. Appendix J includes two options, A 
and B, either of which can be chosen for meeting the requirements of 
this appendix. The Commission has determined that option B to Appendix 
J has no impact on the System 80+ design because ABB-CE elected to 
comply with option A. However, the System 80+ design addresses primary 
reactor containment leakage testing in a manner different from that 
provided in option A, as described in the discussion on exemptions to 
Appendix J below. Therefore, no additional actions are required by this 
design.

10 CFR Parts 50, 70, and 72, Physical Security Plan Format (60 FR 
53507; October 16, 1995)

    The objective of this revised regulation is to eliminate the 
requirement for applicants for power reactor, Category I fuel cycle, 
and spent fuel storage licenses to submit physical security plans in 
two parts. This action is necessary to allow for a quicker and more 
efficient review of the physical security plans. The Commission has 
determined that this revised regulation will be addressed in the COL 
applicant's site-specific security plan. Therefore, no additional 
action is required for this design.

10 CFR Part 50, Fracture Toughness Requirements for Light Water Reactor 
Pressure Vessels (60 FR 65456; December 19, 1995)

    The objective of this revised regulation is to clarify several 
items related to fracture toughness requirements for reactor pressure 
vessels (RPV). This regulation clarifies the pressurized thermal shock 
(PTS) requirements, makes changes to the fractures toughness 
requirements and the reactor vessel material surveillance program 
requirements, and provides new requirements for thermal annealing of a 
reactor pressure vessel. The Commission has determined that 10 CFR 
50.61 only applies to pressurized water reactors for which an operating 
license has been issued. Likewise, 10 CFR 50.66 applies only to those 
light-water reactors where neutron radiation has reduced the fracture 
toughness of the reactor vessel materials. Therefore, no additional 
actions are required by this design.

10 CFR Parts 21, 50, 52, 54, and 100, Reactor Site Criteria Including 
Seismic and Earthquake Engineering Criteria for Nuclear Power Plants 
(61 FR 65157; December 11, 1996)

    The objective of this regulation is to update the criteria used in 
decisions regarding power reactor siting, including geologic, seismic, 
and earthquake engineering considerations for future nuclear power 
plants. Two sections of this regulation apply to applications for 
design certification. With regard to the revised design basis accident 
radiation dose acceptance criteria in 10 CFR 50.34, the Commission has 
determined that the System 80+ design meets the new dose criteria, 
based on the NRC staff's radiological consequence analyses, provided 
that the site parameters are not revised. With regard to the revised 
earthquake engineering criteria for nuclear power plants in Appendix S 
to 10 CFR Part 50, the Commission has determined that the System 80+ 
design meets the new single earthquake design requirements based on the 
NRC staff's evaluation in NUREG-1462. Therefore, the Commission has 
determined that this design meets the applicable requirements of this 
new regulation.

10 CFR Parts 20 and 35, Criteria for the Release of Individuals 
Administered Radioactive Material (62 FR 4120; January 29, 1997)

    The objective of this revised regulation is to specifically state 
that the limitation on dose to individual members of the public in 10 
CFR Part

[[Page 27858]]

20 does not include doses received by individuals exposed to patients 
who were administered radioactive materials and released under the new 
criteria in 10 CFR Part 35. This revision to Part 20 is not applicable 
to the design or operation of nuclear power plants and, therefore, does 
not affect the safety findings for this design.
    In paragraph V.B of this appendix, the Commission identified the 
regulations that do not apply to the System 80+ design. The Commission 
has determined that the System 80+ design should be exempt from 
portions of 10 CFR 50.34(f) and Appendix J to Part 50, as described in 
the FSER (NUREG-1462) and summarized below:
    (1) Paragraph (f)(2)(iv) of 10 CFR 50.34--Separate Plant Safety 
Parameter Display Console.
    10 CFR 50.34(f)(2)(iv) requires that an application provide a plant 
safety parameter display console that will display to operators a 
minimum set of parameters defining the safety status of the plant, be 
capable of displaying a full range of important plant parameters and 
data trends on demand, and be capable of indicating when process limits 
are being approached or exceeded.
    The purpose of the requirement for a safety parameter display 
system (SPDS), as stated in NUREG-0737, ``Clarification of TMI Action 
Plan Requirements,'' Supplement 1, is to ``* * * provide a concise 
display of critical plant variables to the control room operators to 
aid them in rapidly and reliably determining the safety status of the 
plant. * * * and in assessing whether abnormal conditions warrant 
corrective action by operators to avoid a degraded core.''
    ABB-CE committed to meet the intent of this requirement. However, 
the functions of the SPDS will be integrated into the control room 
design rather than on a separate ``console.'' ABB-CE has made the 
following commitments in the generic DCD:
     Section 18.7.1.8.1, Safety-Related Data, states that the 
Nuplex 80+ Advanced Control Complex provides a concise display of 
critical function and success path performance indications to control 
room operators via the Data Processing System (DPS),
     Section 18.7.1.8.1 states that the integrated process 
status overview (IPSO) big board display is a dedicated display which 
continuously shows all critical function alarms and key critical 
function and success path parameters,
     Section 18.7.1.8.1 describes the SPDS for the System 80+ 
and states that all five of the safety function elements are included 
in the DPS critical function hierarchy which forms the basis of the 
Nuplex 80+ SPDS function:
    (a) Reactivity control.
    (b) Reactor core cooling and heat removal from the primary system.
    (c) Reactor coolant system integrity.
    (d) Radioactivity control.
    (e) Containment conditions, and
     Section 18.7.1.8.2 states that the critical function and 
success path monitoring application in conjunction with the continuous 
IPSO display and the DPS CRTs meet SPDS requirements for Nuplex 80+ 
without using stand-alone monitoring and display systems.
    In view of the above, the Commission has determined that an 
exemption from the requirement for an SPDS ``console'' is justified 
based upon (1) the description in the generic DCD of the intent to 
incorporate the SPDS function as part of the plant status summary 
information which is continuously displayed on the fixed-position 
displays on the large display panel; and (2) a separate ``console'' is 
not necessary to achieve the underlying purpose of the SPDS rule which 
is to display to operators a minimum set of parameters defining the 
safety status of the plant. Therefore, the Commission concludes that an 
exemption from 10 CFR 50.34(f)(2)(iv) is justified by the special 
circumstances set forth in 10 CFR 50.12(a)(2)(ii).
    (2) Paragraphs (f)(2) (vii), (viii), (xxvi), and (xxviii) of 10 CFR 
50.34--Accident Source Terms
    10 CFR 50.34(f)(2)(xxviii) requires the evaluation of pathways that 
may lead to control room habitability problems ``under accident 
conditions resulting in a TID 14844 source term release.'' Similar 
wording appears in subparagraphs (vii), (viii), and (xxvi). ABB-CE has 
implemented the new source term technology summarized in Draft NUREG-
1465, ``Accident Source Terms for Light-Water Nuclear Power Plants,'' 
dated June 1992, not the old TID 14844 source term cited in 10 CFR Part 
50.
    The NRC staff has encouraged the development and implementation of 
the new source term technology. The use of the revised source term 
technology is an important departure from previous practice. The new 
approach generally yields lower estimates of fission product releases 
to the environment and will employ a physically-based source term based 
on substantial research and experience gained over two decades. The 
TID-14844 non-mechanistic methodology intentionally employed 
conservative assumptions that were intended to ensure that future 
plants would provide sufficient safety margins even with the recognized 
uncertainties associated with accident sequences and equipment 
reliability. Although the new source term technology may lead to 
relaxation in some aspects of the design, it also provides safety 
benefits by removing unrealistically stringent testing requirements.
    Based on the NRC staff's review and ABB-CE's commitments in Chapter 
15 of the generic DCD, the Commission has determined that the special 
circumstances described in 10 CFR 50.12(a)(ii) exist in that the 
regulation need not be applied in this particular circumstance to 
achieve the underlying purpose because ABB-CE has proposed acceptable 
alternatives that accomplish the intent of the regulation. On this 
basis, the Commission concludes that an exemption from the requirements 
of paragraphs (f)(2) (vii), (viii), (xxvi), and (xxviii) of 10 CFR 
50.34 is justified.
    (3) Paragraph (f)(2)(viii) of 10 CFR 50.34--Post-Accident Sampling 
for Hydrogen, Boron, Chloride, and Dissolved Gases.
    In SECY-93-087, the NRC staff recommended that the Commission 
approve its position for evolutionary and passive ALWRs of the 
pressurized water reactor (PWR) type that they be required to have the 
capability to analyze for dissolved gases in the reactor coolant and 
for hydrogen in the containment atmosphere in accordance with the 
requirements of 10 CFR 50.34(f)(2)(viii) and Item III.B.3 of NUREG-
0737. The NRC staff acknowledged that determination of chloride 
concentrations, although helpful in ensuring that plant personnel take 
appropriate actions to minimize the likelihood of accelerated primary 
system corrosion following the accident, is a secondary consideration 
because long-term samples could likely be taken at a low pressure. 
Therefore, it does not constitute a mandatory requirement of the post-
accident sampling system (PASS). The time for taking these samples can 
be extended to 24 hours following the accident. The NRC staff also 
recommended that the Commission approve the deviation from the 
requirements of Item II.B.3 of NUREG-0737 with regard to the 
requirements for sampling reactor coolant for boron concentration and 
activity measurements using the PASS in evolutionary and passive ALWRs.
    The rationale is that both of these measurements are used only to 
confirm the accident mitigation measures and conditions of the core 
obtained by other methods and do not need to be performed in an early 
phase of an accident. Neutron flux monitoring instrumentation that 
complies with Category I criteria of RG 1.97, will have

[[Page 27859]]

fully qualified, redundant channels that monitor neutron flux over the 
required power range. Therefore, sampling for boron concentration will 
not be needed for the first eight hours after an accident. Samples for 
activity measurements provide the information used in evaluating the 
condition of the core. However, this information will be made available 
during the accident management phase by monitoring other pertinent 
variables. Accordingly, sampling for activity measurement could be 
postponed until 24 hours following an accident.
    In its July 21, 1993, Staff Requirements Memorandum (SRM), the 
Commission approved the recommendation to exempt the PASS for ALWRs of 
PWR design from determining the concentration of hydrogen in the 
containment atmosphere in accordance with the requirements of 10 CFR 
50.34(f)(2)(viii) and Item III.B.3 of NUREG-0737. It also approved 
extending the time limit for analysis of the coolant for boron and 
activity to eight hours and 24 hours, respectively. The Commission 
modified the recommendations regarding evolutionary and passive ALWRs 
of the PWR type to have the capability to determine the gross amount of 
dissolved gases (not necessarily pressurized) as a means to meet the 
intent of 10 CFR 50.34(f)(2)(viii) and Item II.B.3 of NUREG-0737.
    Accordingly, the Commission has determined that the special 
circumstances described in 10 CFR 50.12(a)(2)(ii) exist in that the 
regulation need not be applied in this particular circumstance to 
achieve the underlying purpose because ABB-CE has proposed acceptable 
alternatives that accomplish the intent of the regulation. On this 
basis, the Commission concludes an exemption from the requirements of 
Paragraph (f)(2)(viii) of 10 CFR 50.34 is justified.
    (4) Paragraph (f)(3)(iv) of 10 CFR 50.34--Dedicated Containment 
Penetration.
    Paragraph (3)(iv) of 10 CFR 50.34(f) requires one or more dedicated 
containment penetrations, equivalent in size to a single 0.91 m (3 ft) 
diameter opening, in order not to preclude future installation of 
systems to prevent containment failure such as a filtered containment 
vent system. This requirement is intended to ensure provision of a 
containment vent design feature with sufficient safety margin well 
ahead of a need that may be perceived in the future to mitigate the 
consequences of a severe accident situation.
    In the generic DCD, ABB-CE shows that the containment is 
sufficiently robust to not require venting before 24 hours. However, to 
further improve containment performance, the System 80+ containment is 
equipped with two 7.6-cm (3.0-in.) diameter hydrogen purge vents that 
can be used to relieve containment pressure before containment pressure 
reaches ASME Code Service Level C. With respect to core concrete 
interaction (CCI), the vent could be used to prevent catastrophic 
overpressurization failure of the containment for severe-accident 
sequences involving prolonged periods of CCI. The hydrogen purge vents 
are capable of opening when exposed to an internal pressure 
corresponding to ASME Code Service Level C, of 972 kPa (141 psia) at a 
temperature of 177  deg.C (350  deg.F), and can be powered by the 
alternate AC source.
    ABB-CE has provided this venting capability; however, they have 
demonstrated that venting is not needed for most of the severe-accident 
events. For those sequences in which venting would aid in limiting the 
containment pressure below ASME Code Service Level C limits, venting 
would not be needed before 24 hours after the onset of core damage.
    Based on the NRC staff's review and ABB-CE's commitments in Chapter 
19 of the generic DCD, the Commission determined that the special 
circumstances described in 10 CFR 50.12(a)(ii) exist in that the 
regulation need not be applied in this particular circumstance to 
achieve the underlying purpose because ABB-CE has proposed acceptable 
alternatives that accomplish the intent of the regulation. On this 
basis, the Commission concludes that an exemption from the requirement 
of 10 CFR 50.34(f)(iv) is justified.
    (5) Paragraphs III.A.1(a) and III.C.3(b) of Appendix J to 10 CFR 
50--Containment Leakage Testing.
(a) Paragraph III.A.1(a)
    ABB-CE committed to containment leakage testing for the System 80+ 
design, in accordance with option A to the new Appendix J to 10 CFR 
Part 50, with the following exceptions:
     The COL applicant may use the mass point leak rate test 
method in ANSI/ANS 56.8-1987 as an alternative to Type A testing method 
specified in ANSI 45.4-1972, and
     Leaks occurring during the Type A test that could affect 
the test results will not prevent completion of this test if: (a) The 
leaks are isolated for the balance of the test; (b) the leaking 
component had a ``pre-maintenance'' local leak rate test whose results, 
when added to those from the Type A test, are in conformance with the 
acceptance criteria of Appendix J; or (c) a ``post-maintenance'' local 
leak rate test of the leaking component(s) is performed and the 
results, when added to those from the Type A test, conform to the 
acceptance criteria of Appendix J.
    The first exception is acceptable because the current version of 
Section III.A.3 of Appendix J to 10 CFR Part 50 includes the ANSI/ANS 
56.8-1987 method (mass point method) as an acceptable alternative. The 
second exception does not conform to the requirements of Appendix J to 
10 CFR Part 50. Section III.A.1.(a) of Appendix J requires that a Type 
A test, defined as a test to measure the primary containment overall 
integrated leakage rate be terminated if, during this test, potentially 
excessive leakage paths are identified which would either interface 
with satisfactory completion of the test or which would result in the 
Type A tests not meeting the applicable acceptance criteria of Section 
III.A.4(b) or III.A.5(b). Section III.A.1(a) further requires that, 
after terminating a Type A test due to potentially excessive leakage, 
the leakage through the potentially excessive leakage paths be measured 
using local leakage testing methods and repairs and/or adjustments to 
the affected equipment be made. The Type A test shall then be 
conducted. ABB-CE proposed that the test not be terminated when leakage 
is found during a Type A test. Instead, ABB-CE proposed that leaks be 
isolated and the Type A test continued. After completion of the 
modified Type A test (i.e., a Type A test with the leakage paths 
isolated), local leakage rates of those paths isolated during the 
modified Type A test will be measured before or after the maintenance 
to those paths.
    ABB-CE proposed that the adjusted ``as-found'' leakage rate for the 
Type A test be determined by adding the local leakage rates measured 
before maintenance to those previously isolated leakage paths, to the 
containment integrated leakage rate determined in the modified Type A 
test. This adjusted ``as-found'' leakage rate is to be used in 
determining the scheduling of the periodic Type A tests in accordance 
with Section III.A.6 of Appendix J.
    Finally, ABB-CE proposed that the acceptability of the modified 
Type A test be determined by calculating the adjusted ``as-left'' 
containment overall integrated leakage rate and comparing this to the 
acceptance criteria of Appendix J. The adjusted ``as-left'' Type A 
leakage rate is determined by adding the local leakage rates measured 
after

[[Page 27860]]

any maintenance to those previously isolated leakage paths, to the 
leakage rate determined in the modified Type A test.
    The differences between the proposed leak testing and the 
requirements in Section III.A.1(a) of Appendix J are that: (1) The 
potentially excessive leakage paths will be repaired and/or adjusted 
after completion of the Type A test rather than before the test; and 
(2) the Type A test leakage rate is partially determined by calculation 
rather than by direct measurement. With respect to the first issue, the 
NRC staff does not identify any significant difference in the end 
result (i.e., the ``as-left'' local leakage rates will be maintained 
within an acceptable range). With respect to the second issue, the 
measured ``as-left'' local leakage rates will represent a relatively 
small correction to the containment overall integrated leakage rate 
measured in the modified Type A test. Accordingly, there will be 
insignificant differences between the calculated ``as-left'' 
containment leakage rate (i.e., a modified Type A test) and one that 
would be directly measured in compliance with the requirements of 
Section III.A.1.(a).
    In view of the above, the Commission has determined that the 
special circumstances described in 10 CFR 50.12(a)(2)(ii) exist in that 
the regulation need not be applied in this particular circumstance to 
achieve the underlying purpose because ABB-CE has proposed acceptable 
alternatives that accomplish the intent of the regulation. On this 
basis, the Commission concludes that a partial exemption from the 
requirements of Paragraph III.A.1.(a) of Appendix J to 10 CFR Part 50 
is justified.
(b) Paragraph III.C.3(b)
    In Section 6.2.6 and Table 6.2.4-1 of the generic DCD, ABB-CE 
presented information on the System 80+ containment leakage testing 
program, including the planned leak test data for specific containment 
isolation valves (CIVs). In Table 6.2.4-1, ABB-CE lists those CIVs 
which are vented and drained for the Type A test and those CIVs which 
are subject to the Type C test, and justifies those CIVs not included 
in the Type C test program. ABB-CE presented the following 
justifications for not performing CIV Type C tests:
    1. CIVs on piping connected to the secondary side of the steam 
generator would leak into the containment because, during a design-
basis LOCA, the secondary side pressure is higher than the primary-side 
pressure.
    2. The water always present in the in-containment refueling water 
storage tank (IRWST) seals CIVs on piping connected directly to the 
IRWST.
    3. The discharge pressure from the safety injection pump 
effectively seals against leakage for CIVs on pump discharge (or 
injection) lines.
    4. The shutdown cooling system (SCS) with these CIVs must maintain 
safe shutdown conditions. These CIVs cannot be tested without 
compromising safety and therefore will be separately water tested as 
part of the RCS pressure boundary.
    The NRC staff did not find justifications 3 and 4 acceptable 
because multiple systems would allow the CIVs on one loop to be tested 
while the others are available. The two 100-percent redundant SCS would 
ensure safe shutdown with one system operating while the CIVs in the 
other are being leak tested. If the safety injection pump fails and the 
system switches from cold-leg to hot-leg injection, any leakage from 
the system safety injection pump CIVs would pass to the environment. 
Therefore, the NRC staff concluded that both the SCS and safety 
injection pump system CIVs should be tested for leaks in accordance 
with 10 CFR Part 50, Appendix J.
    ABB-CE rearranged valve elevations so that safety injection system 
(SIS) valves SI-602, 603, 616, 626, 636, and 646 are approximately 1.2 
m (4 ft) below the minimum IRWST water level and SCS valves SI-600 and 
601 are approximately 0.44 m (1.5 ft) below the minimum water level. 
The minimum IRWST water level is at elevation 24.5 m (80.5 ft) which is 
determined by the calculated minimum IRWST water level following a 
large LOCA. By using this valve re-arrangement, the IRWST will provide 
a manometer effect to establish a water seal at the valves because the 
containment pressure is exerted on the surface of the IRWST liquid and 
the SIS forms a closed loop with containment following a pipe break. 
ABB-CE states that it complies with the intent of the regulation in 10 
CFR Part 50, Appendix J, in maintaining water-sealed valves.
    The NRC staff has reviewed the proposed alternative. Appendix J to 
10 CFR Part 50, Section III.C.3(b) states that the installed isolation 
valve seal water system fluid inventory is sufficient to assure the 
sealing function for at least 30 days at a pressure of 1.1 Pa. The 
proposed design of water-sealed isolation valves conforms to the 
requirement of 30-day water inventory but not on the sealing pressure 
of 1.1 Pa. However, the NRC staff finds that the closed loop and the 
manometer effect provide sufficient water sealing as long as the 
integrity of the closed loop and the elevation differential between the 
valves and the water level are maintained. As a result of the review, 
ABB -CE has committed to provide: (1) Periodic pressure testing as 
described in DCD Sections 3.9.6 and 6.6 to ensure the integrity of the 
closed loop SIS outside containment is being maintained; and (2) a pre-
operational test as described in DCD Section 14.2 to ensure the 
existence of the water seal.
    Based on the NRC staff review and ABB-CE's commitment to the above 
periodic and pre-operational tests, the Commission has determined that 
the special circumstances described in 10 CFR 50.12(a)(2)(ii) exist in 
that the regulation need not be applied in this particular circumstance 
to achieve the underlying purpose because ABB-CE has proposed 
acceptable alternatives that accomplish the intent of the regulation. 
On this basis, the Commission concludes that a partial exemption from 
the requirements of Section III.C.3(b) is justified because the 
alternative water-sealed-valve design accomplishes the objectives of 
the regulatory requirement of sealing pressure of 1.1 Pa.
    Paragraph (b)(3) of 10 CFR 50.49--Environmental Qualification of 
Post-Accident Monitoring Equipment.
    In the generic DCD, ABB-CE stated that the design of the 
information systems important to safety will be in conformance with the 
guidelines of Regulatory Guide (RG) 1.97, ``Instrumentation for Light-
Water-Cooled Nuclear Power Plants to Assess Plant and Environs 
Conditions During and Following an Accident,'' Revision 3. The footnote 
for Sec. 50.49(b)(3) references Revision 2 of RG 1.97 for selection of 
the types of post-accident monitoring equipment. As a result, the 
proposed design certification rule provided an exemption to this 
requirement. In section C.1 of its comments, dated August 4, 1995, ABB-
CE stated that it did not believe that an exemption from paragraph 
(b)(3) of 10 CFR 50.49 is needed or required. The Commission agrees 
with ABB-CE's assertion that Revision 2 of RG 1.97 is identified in 
footnote 4 of 10 CFR 50.49 and should not be viewed as binding in this 
instance. Therefore, the Commission has determined that there is no 
need for an exemption from paragraph (b)(3) of 10 CFR 50.49 and has 
removed it from V.B of this appendix.

F. Issue Resolution

    The purpose of Section VI of this appendix is to identify the scope 
of issues that are resolved by the Commission in this rulemaking and; 
therefore, are ``matters resolved'' within

[[Page 27861]]

the meaning and intent of 10 CFR 52.63(a)(4). The section is divided 
into five parts: (A) The Commission's safety findings in adopting this 
appendix, (B) the scope and nature of issues which are resolved by this 
rulemaking, (C) issues which are not resolved by this rulemaking, (D) 
the backfit restrictions applicable to the Commission with respect to 
this appendix, and (E) availability of secondary references.
    Paragraph A describes in general terms the nature of the 
Commission's findings, and makes the finding required by 10 CFR 52.54 
for the Commission's approval of this final design certification rule. 
Furthermore, paragraph A explicitly states the Commission's 
determination that this design provides adequate protection to the 
public health and safety.
    Paragraph B sets forth the scope of issues which may not be 
challenged as a matter of right in subsequent proceedings. The 
introductory phrase of paragraph B clarifies that issue resolution as 
described in the remainder of the paragraph extends to the delineated 
NRC proceedings referencing this appendix. The remaining portion of 
paragraph B describes the general categories of information for which 
there is issue resolution.
    Specifically, paragraph B.1 provides that all nuclear safety issues 
arising from the Atomic Energy Act of 1954, as amended, that are 
associated with the information in the NRC staff's FSER (NUREG-1503) 
and Supplement No. 1, the Tier 1 and Tier 2 information, and the 
rulemaking record for this appendix are resolved within the meaning of 
Sec. 52.63(a)(4). These issues include the information referenced in 
the DCD that are requirements (i.e., ``secondary references''), as well 
as all issues arising from proprietary information which are intended 
to be requirements. Paragraph B.2 provides for issue preclusion of 
proprietary information. As discussed in section II.A.1 of this SOC, 
the inclusion of proprietary information within the scope of issues 
resolved within the meaning of Sec. 52.63(a)(4) represents a change 
from the Commission's intent during the proposed rule. Paragraphs B.3, 
B.4, B.5, and B.6 clarify that approved changes to and departures from 
the DCD which are accomplished in compliance with the relevant 
procedures and criteria in Section VIII of this appendix continue to be 
matters resolved in connection with this rulemaking (refer to the 
discussion in section II.A.1 of this SOC). Paragraph B.7 provides that, 
for those plants located on sites whose site parameters do not exceed 
those assumed in the Technical Support Document (January 1995), all 
issues with respect to severe accident mitigation design alternatives 
(SAMDAs) arising under the National Environmental Policy Act of 1969 
associated with the information in the Environmental Assessment for 
this design and the information regarding SAMDAs in the applicant's 
Technical Support Document (January 1995) are also resolved within the 
meaning and intent of Sec. 52.63(a)(4). Refer to the discussion in 
section II.A.1 of this SOC regarding finality of SAMDAs in the event an 
exemption from a site parameter is granted. The exemption applicant has 
the initial burden of demonstrating that the original SAMDA analysis 
still applies to the actual site parameters but, if the exemption is 
approved, requests for litigation at the COL stage must meet the 
requirements of Sec. 2.714 and present sufficient information to create 
a genuine controversy in order to obtain a hearing on the site 
parameter exemption.
    Paragraph C reserves the right of the Commission to impose 
operational requirements on applicants that reference this appendix. 
This provision reflects the fact that operational requirements, 
including technical specifications, were not completely or 
comprehensively reviewed at the design certification stage. Therefore, 
the special backfit provisions of Sec. 52.63 do not apply to 
operational requirements. However, all design changes would be 
restricted by the appropriate provision in Section VIII of this 
appendix (refer to section III.H of this SOC). Although the information 
in the DCD that is related to operational requirements was necessary to 
support the NRC staff's safety review of this design, the review of 
this information was not sufficient to conclude that the operational 
requirements are fully resolved and ready to be assigned finality under 
Sec. 52.63. As a result, if the NRC wanted to change a temperature 
limit and that operational change required a consequential change to a 
design feature, then the temperature limit backfit would be restricted 
by Sec. 52.63. However, changes to other operational issues, such as 
in-service testing and in-service inspection programs, post-fuel load 
verification activities, and shutdown risk that do not require a design 
change would not be restricted by Sec. 52.63.
    Paragraph C allows the NRC to impose future operational 
requirements (distinct from design matters) on applicants who reference 
this design certification. Also, license conditions for portions of the 
plant within the scope of this design certification, e.g. start-up and 
power ascension testing, are not restricted by Sec. 52.63. The 
requirement to perform these testing programs is contained in Tier 1 
information. However, ITAAC cannot be specified for these subjects 
because the matters to be addressed in these license conditions cannot 
be verified prior to fuel load and operation, when the ITAAC are 
satisfied. Therefore, another regulatory vehicle is necessary to ensure 
that licensees comply with the matters contained in the license 
conditions. License conditions for these areas cannot be developed now 
because this requires the type of detailed design information that will 
be developed after design certification. In the absence of detailed 
design information to evaluate the need for and develop specific post-
fuel load verifications for these matters, the Commission is reserving 
the right to impose license conditions by rule for post-fuel load 
verification activities for portions of the plant within the scope of 
this design certification.
    Paragraph D reiterates the restrictions (contained in 10 CFR 52.63 
and Section VIII of this appendix) placed upon the Commission when 
ordering generic or plant-specific modifications, changes or additions 
to structures, systems or components, design features, design criteria, 
and ITAAC (VI.D.3 addresses ITAAC) within the scope of the certified 
design. Although the Commission does not believe that this language is 
necessary, the Commission has included this language to provide a 
concise statement of the scope and finality of this rule in response to 
comments from NEI.
    Paragraph E provides the procedure for an interested member of the 
public to obtain access to proprietary information for the System 80+ 
design, in order to request and participate in proceedings identified 
in VI.B of this appendix, viz., proceedings involving licenses and 
applications which reference this appendix. As set forth in paragraph 
E, access must first be sought from the design certification applicant. 
If ABB-CE refuses to provide the information, the person seeking access 
shall request access from the Commission or the presiding officer, as 
applicable. Access to the proprietary information may be ordered by the 
Commission, but must be subject to an appropriate non-disclosure 
agreement.

G. Duration of This Appendix

    The purpose of Section VII of this appendix is in part to specify 
the time period during which this design certification may be 
referenced by an applicant for a combined license, pursuant to 10 CFR 
52.55. This section also states that the design certification

[[Page 27862]]

remains valid for an applicant or licensee that references the design 
certification until the application is withdrawn or the license 
expires. Therefore, if an application references this design 
certification during the 15-year period, then the design certification 
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 this appendix 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 changes to or plant-specific departures from information in 
the plant-specific DCD must be made pursuant to the change processes in 
Section VIII of this appendix for the life of the plant.

H. Processes for Changes and Departures

    The purpose of Section VIII of this appendix is to set forth the 
processes for generic changes to or plant-specific departures 
(including exemptions) from the DCD. The Commission adopted this 
restrictive change process in order to achieve a more stable licensing 
process for applicants and licensees that reference this design 
certification rule. Section VIII is divided into three paragraphs, 
which correspond to Tier 1, Tier 2, and Operational requirements. The 
language of Section VIII distinguishes between generic changes to the 
DCD versus plant-specific departures from the DCD. Generic changes must 
be accomplished by rulemaking because the intended subject of the 
change is the design certification rule itself, as is contemplated by 
10 CFR 52.63(a)(1). Consistent with 10 CFR 52.63(a)(2), any generic 
rulemaking changes are applicable to all plants, absent circumstances 
which render the change (``modification'' in the language of 
Sec. 52.63(a)(2)) ``technically irrelevant.'' By contrast, plant-
specific departures could be either a Commission-issued order to one or 
more applicants or licensees; or an applicant or licensee-initiated 
departure applicable only to that applicant's or licensee's plant(s), 
i.e., a Sec. 50.59-like departure or an exemption. Because these plant-
specific departures will result in a DCD that is unique for that plant, 
Section X of this appendix requires an applicant or licensee to 
maintain a plant-specific DCD. For purposes of brevity, this discussion 
refers to both generic changes and plant-specific departures as 
``change processes.''
    Both Section VIII of this appendix and this SOC refer to an 
``exemption'' from one or more requirements of this appendix and the 
criteria for granting an exemption. The Commission cautions that where 
the exemption involves an underlying substantive requirement 
(applicable regulation), then the applicant or licensee requesting the 
exemption must also show that an exemption from the underlying 
applicable requirement meets the criteria of 10 CFR 50.12.
Tier 1
    The change processes for Tier 1 information are covered in 
paragraph VIII.A. Generic changes to Tier 1 are accomplished by 
rulemaking that amends the generic DCD and are governed by the 
standards in 10 CFR 52.63(a)(1). This provision provides that the 
Commission may not modify, change, rescind, or impose new requirements 
by rulemaking except where necessary either to bring the certification 
into compliance with the Commission's regulations applicable and in 
effect at the time of approval of the design certification or to ensure 
adequate protection of the public health and safety or common defense 
and security. The rulemakings must include an opportunity for hearing 
with respect to the proposed change, as required by 10 CFR 52.63(a)(1), 
and the Commission expects such hearings to be conducted in accordance 
with 10 CFR Part 2, Subpart H. Departures from Tier 1 may occur in two 
ways: (1) The Commission may order a licensee to depart from Tier 1, as 
provided in paragraph A.3; or (2) an applicant or licensee may request 
an exemption from Tier 1, as provided in paragraph A.4. If the 
Commission seeks to order a licensee to depart from Tier 1, paragraph 
A.3 requires that the Commission find both that the departure is 
necessary for adequate protection or for compliance, and that special 
circumstances are present. Paragraph A.4 provides that exemptions from 
Tier 1 requested by an applicant or licensee are governed by the 
requirements of 10 CFR 52.63(b)(1) and 52.97(b), which provide an 
opportunity for a hearing. In addition, the Commission will not grant 
requests for exemptions that may result in a significant decrease in 
the level of safety otherwise provided by the design (refer to 
discussion in II.A.3 of this SOC).
Tier 2
    The change processes for the three different categories of Tier 2 
information, viz., Tier 2, Tier 2*, and Tier 2* with a time of 
expiration are set forth in paragraph VIII.B. The change process for 
Tier 2 has the same elements as the Tier 1 change process, but some of 
the standards for plant-specific orders and exemptions are different. 
The Commission also adopted a ``Sec. 50.59-like'' change process in 
accordance with its SRMs on SECY-90-377 and SECY-92-287A.
    The process for generic Tier 2 changes (including changes to Tier 
2* and Tier 2* with a time of expiration) tracks the process for 
generic Tier 1 changes. As set forth in paragraph B.1, generic Tier 2 
changes are accomplished by rulemaking amending the generic DCD, and 
are governed by the standards in 10 CFR 52.63(a)(1). This provision 
provides that the Commission may not modify, change, rescind or impose 
new requirements by rulemaking except where necessary either to bring 
the certification into compliance with the Commission's regulations 
applicable and in effect at the time of approval of the design 
certification or to assure adequate protection of the public health and 
safety or common defense and security. If a generic change is made to 
Tier 2* information, then the category and expiration, if necessary, of 
the new information would also be determined in the rulemaking and the 
appropriate change process for that new information would apply (refer 
to II.A.2 of this SOC).
    Departures from Tier 2 may occur in five ways: (1) The Commission 
may order a plant-specific departure, as set forth in paragraph B.3; 
(2) an applicant or licensee may request an exemption from a Tier 2 
requirement as set forth in paragraph B.4; (3) a licensee may make a 
departure without prior NRC approval in accordance with paragraph B.5 
[the ``Sec. 50.59-like'' process]; (4) the licensee may request NRC 
approval for proposed departures which do not meet the requirements in 
paragraph B.5 as provided in paragraph B.5.d; and (5) the licensee may 
request NRC approval for a departure from Tier 2* information, in 
accordance with paragraph B.6.
    Similar to Commission-ordered Tier 1 departures and generic Tier 2 
changes, Commission-ordered Tier 2 departures cannot be imposed except 
where necessary either to bring the certification into compliance with 
the Commission's regulations applicable and in effect at the time of 
approval of the design certification or to ensure adequate protection 
of the public health and safety or common defense and security, as set 
forth in paragraph B.3. However, the special circumstances for the 
Commission-ordered Tier 2 departures do not have to outweigh any 
decrease in safety that may result from the reduction in 
standardization caused by the plant-specific order, as required

[[Page 27863]]

by 10 CFR 52.63(a)(3). The Commission determined that it was not 
necessary to impose an additional limitation similar to that imposed on 
Tier 1 departures by 10 CFR 52.63 (a)(3) and (b)(1). This type of 
additional limitation for standardization would unnecessarily restrict 
the flexibility of applicants and licensees with respect to Tier 2, 
which by its nature is not as safety significant as Tier 1.
    An applicant or licensee may request an exemption from Tier 2 
information as set forth in paragraph B.4. The applicant or licensee 
must demonstrate that the exemption complies with one of the special 
circumstances in 10 CFR 50.12(a). In addition, the Commission will not 
grant requests for exemptions that may result in a significant decrease 
in the level of safety otherwise provided by the design (refer to 
discussion in II.A.3 of this SOC). However, the special circumstances 
for the exemption do not have to outweigh any decrease in safety that 
may result from the reduction in standardization caused by the 
exemption. If the exemption is requested by an applicant for a license, 
the exemption is subject to litigation in the same manner as other 
issues in the license hearing, consistent with 10 CFR 52.63(b)(1). If 
the exemption is requested by a licensee, then the exemption is subject 
to litigation in the same manner as a license amendment.
    Paragraph B.5 allows an applicant or licensee to depart from Tier 2 
information, without prior NRC approval, if the proposed departure does 
not involve a change to or departure from Tier 1 or Tier 2* 
information, technical specifications, or involves an unreviewed safety 
question (USQ) as defined in B.5.b and B.5.c of this paragraph. The 
technical specifications referred to in B.5.a and B.5.b of this 
paragraph are the technical specifications in Chapter 16 of the generic 
DCD, including bases, for departures made prior to issuance of the COL. 
After issuance of the COL, the plant-specific technical specifications 
are controlling under paragraph B.5 (refer to discussion in II.A.1 of 
this SOC on Finality for Technical Specifications). The bases for the 
plant-specific technical specifications will be controlled by the bases 
control procedures for the plant-specific technical specifications 
(analogous to the bases control provision in the Improved Standard 
Technical Specifications). The definition of a USQ in paragraph B.5.b 
is similar to the definition in 10 CFR 50.59 and it applies to all 
information in Tier 2 except for the information that resolves the 
severe accident issues. The process for evaluating proposed tests or 
experiments not described in Tier 2 will be incorporated into the 
change process for the portion of the design that is outside the scope 
of this design certification. Although paragraph B.5 does not 
specifically state, the Commission has determined that departures must 
also comply with all applicable regulations unless an exemption or 
other relief is obtained.
    The Commission 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 Commission has 
adopted separate criteria in B.5.c for determining whether a departure 
from information that resolves severe accident issues constitutes a 
USQ. For purposes of applying the special criteria in B.5.c, severe 
accident resolutions are limited to design features when the intended 
function of the design feature is relied upon to resolve postulated 
accidents where the reactor core has melted and exited the reactor 
vessel and the containment is being challenged (refer to discussion in 
II.A.2 of this SOC). These design features are identified in Section 
19.11 of the System 80+ DCD and Section 19E of the ABWR DCD, but may be 
described in other sections of the DCD. Therefore, the location of 
design information in the DCD is not important to the application of 
this special procedure for severe accident issues. However, the special 
procedure in B.5.c does not apply to design features that resolve so-
called beyond design basis accidents or other low probability events. 
The important aspect of this special procedure is that it is limited 
solely to severe accident design features, as defined above. Some 
design features of the evolutionary designs have intended functions to 
meet both ``design basis'' requirements and to resolve ``severe 
accidents.'' If these design features are reviewed under paragraph 
VIII.B.5, then the appropriate criteria from either B.5.b or B.5.c are 
selected depending upon the design function being changed.
    An applicant or licensee that plans to depart from Tier 2 
information, under VIII.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, as 
explained above. 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, such as generic issue resolutions that are 
relevant to the proposed departure. The benefits of the early 
resolution of safety issues would be lost if departures from the DCD 
were made that violated these resolutions without appropriate review. 
The evaluation of the relevant matters needs to consider the proposed 
departure over the full range of power operation from startup to 
shutdown, as it relates to anticipated operational occurrences, 
transients, design basis accidents, and severe accidents. The 
evaluation must also include a review of all relevant secondary 
references from the DCD because Tier 2 information intended to be 
treated as requirements is contained in the secondary references. The 
evaluation should consider the tables in Sections 14.3 and 19.8 of the 
DCD to ensure that the proposed change does not impact Tier 1. These 
tables contain various cross-references from the plant safety analyses 
in Tier 2 to the important parameters that were included in Tier 1. 
Although many issues and analyses could have been cross-referenced, the 
listings in these tables were developed only for key plant safety 
analyses for the design. ABB-CE provided more detailed cross-references 
to Tier 1 for these analyses in a letter dated June 10, 1994.
    If a proposed departure from Tier 2 involves a change to or 
departure from Tier 1 or Tier 2* information, technical specifications, 
or otherwise constitutes a USQ, then the applicant or licensee must 
obtain NRC approval through the appropriate process set forth in this 
appendix before implementing the proposed departure. The NRC does not 
endorse NSAC-125, ``Guidelines for 10 CFR 50.59 Safety Evaluations,'' 
for performing safety evaluations required by VIII.B.5 of this 
appendix. However, the NRC will work with industry, if it is desired, 
to develop an appropriate guidance document for processing proposed 
changes under VIII.B of this appendix.
    A party to an adjudicatory proceeding (e.g., for issuance of a 
combined license) who believes that an applicant or licensee has not 
complied with VIII.B.5 when departing from Tier 2 information, may 
petition to admit such a contention into the proceeding. As set forth 
in B.5.f, the petition must comply with the requirements of 
Sec. 2.714(b)(2) and show that the departure does not comply with 
paragraph B.5. Any other party may file a response to the petition. If 
on the basis of the petition and any responses, the presiding officer 
in the proceeding determines that the required showing

[[Page 27864]]

has been made, the matter shall be certified to the Commission for its 
final determination. In the absence of a proceeding, petitions alleging 
non-conformance with paragraph B.5 requirements applicable to Tier 2 
departures will be treated as petitions for enforcement action under 10 
CFR 2.206.
    Paragraph B.6 provides a process for departing from Tier 2* 
information. This provision is bifurcated because of the expiration of 
some Tier 2* information. The Commission determined that the Tier 2* 
designation should expire for some Tier 2* information in response to 
comments from NEI (refer to section II.A.2 of this SOC). Therefore, 
certain Tier 2* information listed in B.6.c is no longer designated as 
Tier 2* information after full power operation is first achieved 
following the Commission finding in 10 CFR 52.103(g). Thereafter, that 
information is deemed to be Tier 2 information that is subject to the 
departure requirements in paragraph B.5. By contrast, the Tier 2* 
information identified in B.6.b retains its Tier 2* designation 
throughout the duration of the license, including any period of 
renewal. Any requests for departures from Tier 2* information that 
affect Tier 1 must also comply with the requirements in VIII.A of this 
appendix.
    If Tier 2* information is changed in a generic rulemaking, the 
designation of the new information (Tier 1, 2*, or 2) would also be 
determined in the rulemaking and the appropriate process for future 
changes would apply. If a plant-specific departure is made from Tier 2* 
information, then the new designation would apply only to that plant. 
If an applicant who references this design certification makes a 
departure from Tier 2* information, the new information is subject to 
litigation in the same manner as other plant-specific issues in the 
licensing hearing (refer to B.6.a). If a licensee makes a departure, it 
will be treated as a license amendment under 10 CFR 50.90 and the 
finality is in accordance with paragraph VI.B.5 of this appendix.
Operational Requirements
    The change process for technical specifications and other 
operational requirements is set forth in paragraph VIII.C. This change 
process has elements similar to the Tier 1 and Tier 2 change process in 
paragraphs VIII.A and VIII.B, but with significantly different change 
standards (refer to the explanation in II.A.1 of this SOC). The 
Commission did not support NEI's request to extend the special backfit 
provisions of 10 CFR 52.63 to technical specifications and other 
operational requirements (refer to explanation in III.F of this SOC). 
Rather, the Commission decided to designate a special category of 
information, consisting of the technical specifications and other 
operational requirements, with its own change process in paragraph 
VIII.C. The key to using the change processes in Section VIII is to 
determine if the proposed change or departure requires a change to a 
design feature described in the generic DCD. If a design change is 
required, then the appropriate change process in paragraph VIII.A or 
VIII.B applies. However, if a proposed change to the technical 
specifications or other operational requirements does not require a 
change to a design feature in the generic DCD, then paragraph VIII.C 
applies. The language in paragraph VIII.C also distinguishes between 
generic and plant-specific technical specifications to account for the 
different treatment and finality accorded technical specifications 
before and after a license is issued.
    The process in C.1 for making generic changes to the generic 
technical specifications in Chapter 16 of the DCD or other operational 
requirements in the generic DCD is accomplished by rulemaking and 
governed by the backfit standards in 10 CFR 50.109. The determination 
of whether the generic technical specifications and other operational 
requirements were completely reviewed and approved in the design 
certification rulemaking is based upon the extent to which an NRC 
safety conclusion in the FSER or its supplement is being modified or 
changed. If it cannot be determined that the technical specification or 
operational requirement was comprehensively reviewed and finalized in 
the design certification rulemaking, then there is no backfit 
restriction under 10 CFR 50.109 because no prior position was taken on 
this safety matter. Some generic technical specifications contain 
bracketed values, which clearly indicate that the NRC staff's review 
was not complete. Generic changes made under VIII.C.1 are applicable to 
all applicants or licensees, unless the change is irrelevant because of 
a plant-specific departure (refer to VIII.C.2).
    Plant-specific departures may occur by either a Commission order 
under VIII.C.3 or an applicant's exemption request under VIII.C.4. The 
basis for determining if the technical specification or operational 
requirement was completely reviewed and approved is the same as for 
VIII.C.1 above. If the technical specification or operational 
requirement was comprehensively reviewed and finalized in the design 
certification rulemaking, then the Commission must demonstrate that 
special circumstances are present before ordering a plant-specific 
departure. If not, there is no restriction on plant-specific changes to 
the technical specifications or operational requirements, prior to 
issuance of a license, provided a design change is not required. 
Although the generic technical specifications were reviewed by the NRC 
staff to facilitate the design certification review, the Commission 
intends to consider the lessons learned from subsequent operating 
experience during its licensing review of the plant-specific technical 
specifications. The process for petitioning to intervene on a technical 
specification or operational requirement is similar to other issues in 
a licensing hearing, except that the petitioner must also demonstrate 
why special circumstances are present (refer to VIII.C.5).
    Finally, the generic technical specifications will have no further 
effect on the plant-specific technical specifications after the 
issuance of a license that references this appendix (refer to sections 
II.A.1 and II.B.3 of this SOC). The bases for the generic technical 
specifications will be controlled by the change process in Section 
VIII.C of this appendix. After a license is issued, the bases will be 
controlled by the bases change provision set forth in the 
administrative controls section of the plant-specific technical 
specifications.

I. Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC)

    The purpose of Section IX of this appendix is to set forth how the 
ITAAC in Tier 1 of this design certification rule are to be treated in 
a license proceeding. Paragraph A restates the responsibilities of an 
applicant or licensee for performing and successfully completing ITAAC, 
and notifying the NRC of such completion. Paragraph A.1 makes it clear 
that an applicant may proceed at its own risk with design and 
procurement activities subject to ITAAC, and that a licensee may 
proceed at its own risk with design, procurement, construction, and 
preoperational testing activities subject to an ITAAC, even though the 
NRC may not have found that any particular ITAAC has been successfully 
completed. Paragraph A.2 requires the licensee to notify the NRC that 
the required inspections, tests, and analyses in the ITAAC have been 
completed and that the acceptance criteria have been met.

[[Page 27865]]

    Paragraphs B.1 and B.2 essentially reiterate the NRC's 
responsibilities with respect to ITAAC as set forth in 10 CFR 52.99 and 
52.103(g) [refer to explanation in section II.C.1 of this SOC]. 
Finally, paragraph B.3 states that ITAAC do not, by virtue of their 
inclusion in the DCD, constitute regulatory requirements after the 
licensee has received authorization to load fuel or for renewal of the 
license. However, subsequent modifications must comply with the design 
descriptions in the DCD unless the applicable requirements in 10 CFR 
52.97 and Section VIII of this appendix have been complied with. As 
discussed in sections II.B.9 and III.D of this SOC, the Commission will 
defer a determination of the applicability of ITAAC and their effect in 
terms of issue resolution in 10 CFR Part 50 licensing proceedings to 
such time that a Part 50 applicant decides to reference this appendix.

J. Records and Reporting

    The purpose of Section X of this appendix is to set forth the 
requirements for maintaining records of changes to and departures from 
the generic DCD, which are to be reflected in the plant-specific DCD. 
Section X also sets forth the requirements for submitting reports 
(including updates to the plant-specific DCD) to the NRC. This section 
of the appendix is similar to the requirements for records and reports 
in 10 CFR Part 50, except for minor differences in information 
collection and reporting requirements, as discussed in section V of 
this SOC. Paragraph X.A.1 of this appendix requires that a generic DCD 
and the proprietary information referenced in the generic DCD be 
maintained by the applicant for this rule. The generic DCD was 
developed, in part, to meet the requirements for incorporation by 
reference, including availability requirements. Therefore, the 
proprietary information could not be included in the generic DCD 
because it is not publicly available. However, the proprietary 
information was reviewed by the NRC and, as stated in paragraph VI.B.2 
of this appendix, the Commission considers the information to be 
resolved within the meaning of 10 CFR 52.63(a)(4). Because this 
information is not in the generic DCD, the proprietary information, or 
its equivalent, is required to be provided by an applicant for a 
license. Therefore, to ensure that this information will be available, 
a requirement for the design certification applicant to maintain the 
proprietary information was added to paragraph X.A.1 of this appendix. 
The acceptable version of the proprietary information is identified in 
the version of the DCD that is incorporated into this rule. The generic 
DCD and the acceptable version of the proprietary information must be 
maintained for the period of time that this appendix may be referenced.
    Paragraphs A.2 and A.3 place record-keeping requirements on the 
applicant or licensee that references this design certification to 
maintain its plant-specific DCD to accurately reflect both generic 
changes to the generic DCD and plant-specific departures made pursuant 
to Section VIII of this appendix. The term ``plant-specific'' was added 
to paragraph A.2 and other Sections of this appendix to distinguish 
between the generic DCD that is incorporated by reference into this 
appendix, and the plant-specific DCD that the applicant is required to 
submit under IV.A of this appendix. The requirement to maintain the 
generic changes to the generic DCD is explicitly stated to ensure that 
these changes are not only reflected in the generic DCD, which will be 
maintained by the applicant for design certification, but that the 
changes are also reflected in the plant-specific DCD. Therefore, 
records of generic changes to the DCD will be required to be maintained 
by both entities to ensure that both entities have up-to-date DCDs.
    Section X.A of this appendix does not place record-keeping 
requirements on site-specific information that is outside the scope of 
this rule. As discussed in section III.D of this SOC, the final safety 
analysis report required by 10 CFR 52.79 will contain the plant-
specific DCD and the site-specific information for a facility that 
references this rule. The phrase ``site-specific portion of the final 
safety analysis report'' in paragraph X.B.3.d of this appendix refers 
to the information that is contained in the final safety analysis 
report for a facility (required by 10 CFR 52.79) but is not part of the 
plant-specific DCD (required by IV.A of this appendix). Therefore, this 
rule does not require that duplicate documentation be maintained by an 
applicant or licensee that references this rule, because the plant-
specific DCD is part of the final safety analysis report for the 
facility (refer to section II.C.3 of this SOC).
    Paragraphs B.1 and B.2 establish reporting requirements for 
applicants or licensees that reference this rule that are similar to 
the reporting requirements in 10 CFR Part 50. For currently operating 
plants, a licensee is required to maintain records of the basis for any 
design changes to the facility made under 10 CFR 50.59. Section 
50.59(b)(2) requires a licensee to provide a summary report of these 
changes to the NRC annually, or along with updates to the facility 
final safety analysis report under 10 CFR 50.71(e). Section 50.71(e)(4) 
requires that these updates be submitted annually, or 6 months after 
each refueling outage if the interval between successive updates does 
not exceed 24 months.
    The reporting requirements vary according to four different time 
periods during a facilities' lifetime as specified in paragraph B.3. 
Paragraph B.3.a requires that if an applicant that references this rule 
decides to make departures from the generic DCD, then the departures 
and any updates to the plant-specific DCD must be submitted with the 
initial application for a license. Under B.3.b, the applicant may 
submit any subsequent reports and updates along with its amendments to 
the application provided that the submittals are made at least once per 
year. Because amendments to an application are typically made more 
frequently than once a year, this should not be an excessive burden on 
the applicant.
    Paragraph B.3.c requires that the reports be submitted quarterly 
during the period of facility construction. This increase in frequency 
of summary reports of departures from the plant-specific DCD is in 
response to the Commission's guidance on reporting frequency in its SRM 
on SECY-90-377, dated February 15, 1991. NEI stated in its comments 
dated August 4, 1995 (Attachment B, p. 116) that * * * ``the 
requirement for quarterly reporting imposes unnecessary additional 
burdens on licensees and the NRC.'' NEI recommended that the Commission 
adopt a ``less onerous'' requirement (e.g., semi-annual reports). The 
Commission disagrees with the NEI request because it does not provide 
for sufficiently timely notification of design changes during the 
critical period of facility construction. Also, the Commission 
disagrees that the reports are an onerous burden because they are only 
summary reports, which describe the design changes, rather than 
detailed evaluations of the changes and determinations. The detailed 
evaluations remain available for audit on site, consistent with the 
requirements of 10 CFR Part 50.
    Quarterly reporting of design changes during the period of 
construction is necessary to closely monitor the status and progress of 
the construction of the plant. To make its finding under 10 CFR 52.99, 
the NRC must monitor the design changes made in accordance with Section 
VIII of this appendix. The ITAAC verify that the as-built facility 
conforms with the approved design and emphasizes design reconciliation 
and design verification. Quarterly reporting of design changes is 
particularly

[[Page 27866]]

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. The frequency of updates to the 
plant-specific DCD is not increased during facility construction. After 
the facility begins operation, the frequency of reporting reverts to 
the requirement in paragraph X.B.3.d, which is consistent with the 
requirement for plants licensed under 10 CFR Part 50.

IV. Finding of No Significant Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended (NEPA), and the Commission's regulations 
in 10 CFR Part 51, Subpart A, that this design certification rule is 
not 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 final environmental assessment, is that this amendment to 10 CFR 
Part 52 does not authorize the siting, construction, or operation of a 
facility using the System 80+ design; it only codifies 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 final environmental assessment for the 
System 80+ design, the NRC reviewed ABB-CE's evaluation of various 
design alternatives to prevent and mitigate severe accidents that was 
submitted in its ``Technical Support Document,'' dated January 1995. 
The Commission finds that ABB-CE's evaluation provides a sufficient 
basis to conclude that there are no additional severe accident design 
alternatives beyond those currently incorporated into the System 80+ 
design which are cost-beneficial, whether considered at the time of the 
approval of the design certification or in connection with the 
licensing of a future facility referencing the System 80+ design 
certification, where the plant referencing this appendix is located on 
a site whose site parameters are within those specified in the 
Technical Support Document. These issues are considered resolved for 
the System 80+ design.
    The final environmental assessment, upon which the Commission's 
finding of no significant impact is based, and the Technical Support 
Document for the System 80+ design 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. Dino 
C. Scaletti, Mailstop O-11 H3, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555, (301) 415-1104.

V. Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). These requirements were approved by the Office of Management and 
Budget, approval number 3150-0151. Should an application be received, 
the additional public reporting burden for this collection of 
information, above those contained in Part 52, is estimated to average 
8 hours per response, including the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information. 
Send comments on any aspect of this collection of information, 
including suggestions for reducing the burden, to the Information and 
Records Management Branch (T-6 F33), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by Internet electronic mail 
at [email protected]; and to the Desk Officer, Office of Information and 
Regulatory Affairs, NEOB-10202, (3150-0151), Office of Management and 
Budget, Washington, DC 20503.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

VI. Regulatory Analysis

    The NRC has not prepared a regulatory analysis for this final rule. 
The NRC prepares regulatory analyses for rulemakings that establish 
generic regulatory requirements applicable to all licensees. Design 
certifications are not generic rulemakings in the sense that design 
certifications do not establish standards or requirements with which 
all licensees must comply. 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.

VII. Regulatory Flexibility Act Certification

    In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the Commission certifies that this rulemaking will not have a 
significant economic impact upon a substantial number of small 
entities. The rule provides certification for a nuclear power plant 
design. Neither the design certification applicant nor prospective 
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.

VIII. Backfit Analysis

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

List of Subjects in 10 CFR Part 52

    Administrative practice and procedure, Antitrust, Backfitting, 
Combined license, Early site permit, Emergency planning, Fees, 
Incorporation by reference, Inspection, Limited work authorization, 
Nuclear power plants and reactors, Probabilistic risk assessment, 
Prototype, Reactor siting criteria, Redress of site, Reporting and 
recordkeeping requirements, Standard design, Standard design 
certification.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting 
the following amendments 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, as amended (42 
U.S.C. 5841, 5842, 5846).

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

[[Page 27867]]

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+ 
Design

I. Introduction

    Appendix B constitutes design certification for the System 80+ 
1 standard plant 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.
---------------------------------------------------------------------------

II. Definitions

    A. Generic design control document (generic DCD) means the 
document containing the Tier 1 and Tier 2 information and generic 
technical specifications that is incorporated by reference into this 
appendix.
    B. Generic technical specifications means the information, 
required by 10 CFR 50.36 and 50.36a, for the portion of the plant 
that is within the scope of this appendix.
    C. Plant-specific DCD means the document, maintained by an 
applicant or licensee who references this appendix, consisting of 
the information in the generic DCD, as modified and supplemented by 
the plant-specific departures and exemptions made under Section VIII 
of this appendix.
    D. Tier 1 means the portion of the design-related information 
contained in the generic DCD that is approved and certified by this 
appendix (hereinafter Tier 1 information). The design descriptions, 
interface requirements, and site parameters are derived from Tier 2 
information. Tier 1 information includes:
    1. Definitions and general provisions;
    2. Design descriptions;
    3. Inspections, tests, analyses, and acceptance criteria 
(ITAAC);
    4. Significant site parameters; and
    5. Significant interface requirements.
    E. Tier 2 means the portion of the design-related information 
contained in the generic DCD that is approved but not certified by 
this appendix (hereinafter Tier 2 information). Compliance with Tier 
2 is required, but generic changes to and plant-specific departures 
from Tier 2 are governed by Section VIII of this appendix. 
Compliance with Tier 2 provides a sufficient, but not the only 
acceptable, method for complying with Tier 1. Compliance methods 
differing from Tier 2 must satisfy the change process in Section 
VIII of this appendix. Regardless of these differences, an applicant 
or licensee must meet the requirement in Section III.B to reference 
Tier 2 when referencing Tier 1. Tier 2 information includes:
    1. Information required by 10 CFR 52.47, with the exception of 
generic technical specifications and conceptual design information;
    2. Information required for a final safety analysis report under 
10 CFR 50.34;
    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; and
    4. Combined license (COL) action items (COL license 
information), which identify certain matters that shall be addressed 
in the site-specific portion of the final safety analysis report 
(FSAR) by an applicant who references this appendix. These items 
constitute information requirements but are not the only acceptable 
set of information in the FSAR. An applicant may depart from or omit 
these items, provided that the departure or omission is identified 
and justified in the FSAR. After issuance of a construction permit 
or COL, these items are not requirements for the licensee unless 
such items are restated in the FSAR.
    F. Tier 2* means the portion of the Tier 2 information, 
designated as such in the generic DCD, which is subject to the 
change process in VIII.B.6 of this appendix. This designation 
expires for some Tier 2* information under VIII.B.6.
    G. All other terms in this appendix 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.

III. Scope and Contents

    A. Tier 1, Tier 2, and the generic technical specifications in 
the System 80+ Design Control Document, ABB-CE, with revisions dated 
January 1997, are approved for incorporation by reference by the 
Director of the Office of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR Part 51. Copies of the generic DCD may be 
obtained from the National Technical Information Service, 5285 Port 
Royal Road, Springfield, VA 22161. A copy is available for 
examination and copying at the NRC Public Document Room, 2120 L 
Street NW. (Lower Level), Washington, DC 20555. Copies are also 
available for examination at the NRC Library, 11545 Rockville Pike, 
Rockville, Maryland 20582 and the Office of the Federal Register, 
800 North Capitol Street, NW., Suite 700, Washington, DC.
    B. An applicant or licensee referencing this appendix, in 
accordance with Section IV of this appendix, shall incorporate by 
reference and comply with the requirements of this appendix, 
including Tier 1, Tier 2, and the generic technical specifications 
except as otherwise provided in this appendix. Conceptual design 
information, as set forth in the generic DCD, and the Technical 
Support Document for the System 80+ design are not part of this 
appendix.
    C. If there is a conflict between Tier 1 and Tier 2 of the DCD, 
then Tier 1 controls.
    D. If there is a conflict between the generic DCD and either the 
application for design certification of the System 80+ design or 
NUREG-1462, ``Final Safety Evaluation Report related to the 
Certification of the System 80+ Design,'' (FSER) and Supplement No. 
1, then the generic DCD controls.
    E. Design activities for structures, systems, and components 
that are wholly outside the scope of this appendix may be performed 
using site-specific design parameters, provided the design 
activities do not affect the DCD or conflict with the interface 
requirements.

IV. Additional Requirements and Restrictions

    A. An applicant for a license that wishes to reference this 
appendix shall, in addition to complying with the requirements of 10 
CFR 52.77, 52.78, and 52.79, comply with the following requirements:
    1. Incorporate by reference, as part of its application, this 
appendix;
    2. Include, as part of its application:
    a. A plant-specific DCD containing the same information and 
utilizing the same organization and numbering as the generic DCD for 
the System 80+ design, as modified and supplemented by the 
applicant's exemptions and departures;
    b. The reports on departures from and updates to the plant-
specific DCD required by X.B of this appendix;
    c. Plant-specific technical specifications, consisting of the 
generic and site-specific technical specifications, that are 
required by 10 CFR 50.36 and 50.36a;
    d. Information demonstrating compliance with the site parameters 
and interface requirements;
    e. Information that addresses the COL action items; and
    f. Information required by 10 CFR 52.47(a) that is not within 
the scope of this appendix.
    3. Physically include, in the plant-specific DCD, the 
proprietary information referenced in the System 80+ DCD.
    B. The Commission reserves the right to determine in what manner 
this appendix may be referenced by an applicant for a construction 
permit or operating license under 10 CFR Part 50.

V. Applicable Regulations

    A. Except as indicated in paragraph B of this section, the 
regulations that apply to the System 80+ design are in 10 CFR Parts 
20, 50, 73, and 100, codified as of May 9, 1997, that are applicable 
and technically relevant, as described in the FSER (NUREG-1462) and 
Supplement No. 1.
    B. The System 80+ design is exempt from portions of the 
following regulations:
    1. Paragraph (f)(2)(iv) of 10 CFR 50.34--Separate Plant Safety 
Parameter Display Console;
    2. Paragraphs (f)(2) (vii), (viii), (xxvi), and (xxviii) of 10 
CFR 50.34--Accident Source Terms;
    3. Paragraph (f)(2)(viii) of 10 CFR 50.34--Post-Accident 
Sampling for Hydrogen, Boron, Chloride, and Dissolved Gases;
    4. Paragraph (f)(3)(iv) of 10 CFR 50.34--Dedicated Containment 
Penetration; and
    5. Paragraphs III.A.1(a) and III.C.3(b) of Appendix J to 10 CFR 
50--Containment Leakage Testing.

VI. Issue Resolution

    A. The Commission has determined that the structures, systems, 
components, and design features of the System 80+ design comply with 
the provisions of the Atomic Energy Act of 1954, as amended, and the 
applicable regulations identified in Section V of this appendix; and 
therefore, provide

[[Page 27868]]

adequate protection to the health and safety of the public. A 
conclusion that a matter is resolved includes the finding that 
additional or alternative structures, systems, components, design 
features, design criteria, testing, analyses, acceptance criteria, 
or justifications are not necessary for the System 80+ design.
    B. The Commission considers the following matters resolved 
within the meaning of 10 CFR 52.63(a)(4) in subsequent proceedings 
for issuance of a combined license, amendment of a combined license, 
or renewal of a combined license, proceedings held pursuant to 10 
CFR 52.103, and enforcement proceedings involving plants referencing 
this appendix:
    1. All nuclear safety issues, except for the generic technical 
specifications and other operational requirements, associated with 
the information in the FSER and Supplement No. 1, Tier 1, Tier 2 
(including referenced information which the context indicates is 
intended as requirements), and the rulemaking record for 
certification of the System 80+ design;
    2. All nuclear safety issues associated with the information in 
proprietary documents, referenced and in context, are intended as 
requirements in the generic DCD for the System 80+ design;
    3. All generic changes to the DCD pursuant to and in compliance 
with the change processes in Sections VIII.A.1 and VIII.B.1 of this 
appendix;
    4. All exemptions from the DCD pursuant to and in compliance 
with the change processes in Sections VIII.A.4 and VIII.B.4 of this 
appendix, but only for that proceeding;
    5. All departures from the DCD that are approved by license 
amendment, but only for that proceeding;
    6. Except as provided in VIII.B.5.f of this appendix, all 
departures from Tier 2 pursuant to and in compliance with the change 
processes in VIII.B.5 of this appendix that do not require prior NRC 
approval;
    7. All environmental issues concerning severe accident 
mitigation design alternatives associated with the information in 
the NRC's final environmental assessment for the System 80+ design 
and the Technical Support Document for the System 80+ design, dated 
January 1995, for plants referencing this appendix whose site 
parameters are within those specified in the Technical Support 
Document.
    C. The Commission does not consider operational requirements for 
an applicant or licensee who references this appendix to be matters 
resolved within the meaning of 10 CFR 52.63(a)(4). The Commission 
reserves the right to require operational requirements for an 
applicant or licensee who references this appendix by rule, 
regulation, order, or license condition.
    D. Except in accordance with the change processes in Section 
VIII of this appendix, the Commission may not require an applicant 
or licensee who references this appendix to:
    1. Modify structures, systems, components, or design features as 
described in the generic DCD;
    2. Provide additional or alternative structures, systems, 
components, or design features not discussed in the generic DCD; or
    3. Provide additional or alternative design criteria, testing, 
analyses, acceptance criteria, or justification for structures, 
systems, components, or design features discussed in the generic 
DCD.
    E.1. Persons who wish to review proprietary information or other 
secondary references in the DCD for the System 80+ design, in order 
to request or participate in the hearing required by 10 CFR 52.85 or 
the hearing provided under 10 CFR 52.103, or to request or 
participate in any other hearing relating to this appendix in which 
interested persons have adjudicatory hearing rights, shall first 
request access to such information from ABB-CE. The request must 
state with particularity:
    a. The nature of the proprietary or other information sought;
    b. The reason why the information currently available to the 
public in the NRC's public document room is insufficient;
    c. The relevance of the requested information to the hearing 
issue(s) which the person proposes to raise; and
    d. A showing that the requesting person has the capability to 
understand and utilize the requested information.
    2. If a person claims that the information is necessary to 
prepare a request for hearing, the request must be filed no later 
than 15 days after publication in the Federal Register of the notice 
required either by 10 CFR 52.85 or 10 CFR 52.103. If ABB-CE declines 
to provide the information sought, ABB-CE shall send a written 
response within ten (10) days of receiving the request to the 
requesting person setting forth with particularity the reasons for 
its refusal. The person may then request the Commission (or 
presiding officer, if a proceeding has been established) to order 
disclosure. The person shall 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 
Commission and presiding officer shall base their decisions solely 
on the person's original request (including any clarifying 
information provided by the requesting person to ABB-CE), and ABB-
CE's response. The Commission and presiding officer may order ABB-CE 
to provide access to some or all of the requested information, 
subject to an appropriate nondisclosure agreement.

VII. Duration of This Appendix

    This appendix may be referenced for a period of 15 years from 
June 20, 1997, except as provided for in 10 CFR 52.55(b) and 
52.57(b). This appendix remains valid for an applicant or licensee 
who references this appendix until the application is withdrawn or 
the license expires, including any period of extended operation 
under a renewed license.

VIII. Processes for Changes and Departures

    A. Tier 1 information.
    1. Generic 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 
applicants or licensees who reference this appendix, except those 
for which the change has been rendered technically irrelevant by 
action taken under paragraphs A.3 or A.4 of this section.
    3. Departures from Tier 1 information that are required 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) and Sec. 52.97(b). The Commission 
will deny a request for an exemption from Tier 1, if it finds that 
the design change will result in a significant decrease in the level 
of safety otherwise provided by the design.
    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 
applicants or licensees who reference this appendix, except those 
for which the change has been rendered technically irrelevant by 
action taken under paragraphs B.3, B.4, B.5, or B.6 of this section.
    3. The Commission may not require new requirements on Tier 2 
information by plant-specific order while this appendix is in effect 
under Secs. 52.55 or 52.61, unless:
    a. A modification is necessary to secure compliance with the 
Commission's regulations applicable and in effect at the time this 
appendix was approved, as set forth in Section V of this appendix, 
or to assure adequate protection of the public health and safety or 
the common defense and security; and
    b. Special circumstances as defined in 10 CFR 50.12(a) are 
present.
    4. An applicant or licensee who references this appendix 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 Commission will 
deny a request for an exemption from Tier 2, if it finds that the 
design change will result in a significant decrease in the level of 
safety otherwise provided by the design. The grant of an exemption 
to an applicant must be subject to litigation in the same manner as 
other issues material to the license hearing. The grant of an 
exemption to a licensee must be subject to an opportunity for a 
hearing in the same manner as license amendments.
    5.a. An applicant or licensee who references this appendix may 
depart from Tier 2 information, without prior NRC approval, unless 
the proposed departure involves a change to or departure from Tier 1 
information, Tier 2* information, or the technical specifications, 
or involves an unreviewed safety question as defined in paragraphs 
B.5.b and B.5.c of this section. When evaluating the proposed 
departure, an applicant or licensee shall consider all matters 
described in the plant-specific DCD.
    b. A proposed departure from Tier 2, other than one affecting 
resolution of a severe accident issue identified in the plant-
specific DCD, involves an unreviewed safety question if--
    (1) The probability of occurrence or the consequences of an 
accident or malfunction of equipment important to safety previously 
evaluated in the plant-specific DCD may be increased;

[[Page 27869]]

    (2) A possibility for an accident or malfunction of a different 
type than any evaluated previously in the plant-specific DCD may be 
created; or
    (3) The margin of safety as defined in the basis for any 
technical specification is reduced.
    c. A proposed departure from Tier 2 affecting resolution of a 
severe accident issue identified in the plant-specific DCD, involves 
an unreviewed safety question if--
    (1) 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
    (2) There is a substantial increase in the consequences to the 
public of a particular severe accident previously reviewed.
    d. If a departure involves an unreviewed safety question as 
defined in paragraph B.5 of this section, it is governed by 10 CFR 
50.90.
    e. A departure from Tier 2 information that is made under 
paragraph B.5 of this section does not require an exemption from 
this appendix.
    f. A party to an adjudicatory proceeding for either the 
issuance, amendment, or renewal of a license or for operation under 
10 CFR 52.103(a), who believes that an applicant or licensee who 
references this appendix has not complied with VIII.B.5 of this 
appendix when departing from Tier 2 information, may petition to 
admit into the proceeding such a contention. In addition to 
compliance with the general requirements of 10 CFR 2.714(b)(2), the 
petition must demonstrate that the departure does not comply with 
VIII.B.5 of this appendix. Further, the petition must demonstrate 
that the change bears on an asserted noncompliance with an ITAAC 
acceptance criterion in the case of a 10 CFR 52.103 preoperational 
hearing, or that the change bears directly on the amendment request 
in the case of a hearing on a license amendment. Any other party may 
file a response. If, on the basis of the petition and any response, 
the presiding officer determines that a sufficient showing has been 
made, the presiding officer shall certify the matter directly to the 
Commission for determination of the admissibility of the contention. 
The Commission may admit such a contention if it determines the 
petition raises a genuine issue of fact regarding compliance with 
VIII.B.5 of this appendix.
    6.a. An applicant who references this appendix may not depart 
from Tier 2* information, which is designated with italicized text 
or brackets and an asterisk in the generic DCD, without NRC 
approval. The departure will not be considered a resolved issue, 
within the meaning of Section VI of this appendix and 10 CFR 
52.63(a)(4).
    b. A licensee who references this appendix may not depart from 
the following Tier 2* matters without prior NRC approval. A request 
for a departure will be treated as a request for a license amendment 
under 10 CFR 50.90.
    (1) Maximum fuel rod average burnup.
    (2) Control room human factors engineering.
    c. A licensee who references this appendix may not, before the 
plant first achieves full power following the finding required by 10 
CFR 52.103(g), depart from the following Tier 2* matters except in 
accordance with paragraph B.6.b of this section. After the plant 
first achieves full power, the following Tier 2* matters revert to 
Tier 2 status and are thereafter subject to the departure provisions 
in paragraph B.5 of this section.
    (1) ASME Boiler & Pressure Vessel Code, Section III.
    (2) ACI 349 and ANSI/AISC N-690.
    (3) Motor-operated valves.
    (4) Equipment seismic qualification methods.
    (5) Piping design acceptance criteria.
    (6) Fuel and control rod design, except burnup limit.
    (7) Instrumentation & controls setpoint methodology.
    (8) Instrumentation & controls hardware and software changes.
    (9) Instrumentation & controls environmental qualification.
    (10) Seismic design criteria for non-seismic category I 
structures.
    d. Departures from Tier 2* information that are made under 
paragraph B.6 of this section do not require an exemption from this 
appendix.
    C. Operational requirements.
    1. Generic changes to generic technical specifications and other 
operational requirements that were completely reviewed and approved 
in the design certification rulemaking and do not require a change 
to a design feature in the generic DCD are governed by the 
requirements in 10 CFR 50.109. Generic changes that do require a 
change to a design feature in the generic DCD are governed by the 
requirements in paragraphs A or B of this section.
    2. Generic changes to generic technical specifications and other 
operational requirements are applicable to all applicants or 
licensees who reference this appendix, except those for which the 
change has been rendered technically irrelevant by action taken 
under paragraphs C.3 or C.4 of this section.
    3. The Commission may require plant-specific departures on 
generic technical specifications and other operational requirements 
that were completely reviewed and approved, provided a change to a 
design feature in the generic DCD is not required and special 
circumstances as defined in 10 CFR 2.758(b) are present. The 
Commission may modify or supplement generic technical specifications 
and other operational requirements that were not completely reviewed 
and approved or require additional technical specifications and 
other operational requirements on a plant-specific basis, provided a 
change to a design feature in the generic DCD is not required.
    4. An applicant who references this appendix may request an 
exemption from the generic technical specifications or other 
operational requirements. 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 grant of an exemption must be 
subject to litigation in the same manner as other issues material to 
the license hearing.
    5. A party to an adjudicatory proceeding for either the 
issuance, amendment, or renewal of a license or for operation under 
10 CFR 52.103(a), who believes that an operational requirement 
approved in the DCD or a technical specification derived from the 
generic technical specifications must be changed may petition to 
admit into the proceeding such a contention. Such petition must 
comply with the general requirements of 10 CFR 2.714(b)(2) and must 
demonstrate why special circumstances as defined in 10 CFR 2.758(b) 
are present, or for compliance with the Commission's regulations in 
effect at the time this appendix was approved, as set forth in 
Section V of this appendix. Any other party may file a response 
thereto. If, on the basis of the petition and any response, the 
presiding officer determines that a sufficient showing has been 
made, the presiding officer shall certify the matter directly to the 
Commission for determination of the admissibility of the contention. 
All other issues with respect to the plant-specific technical 
specifications or other operational requirements are subject to a 
hearing as part of the license proceeding.
    6. After issuance of a license, the generic technical 
specifications have no further effect on the plant-specific 
technical specifications and changes to the plant-specific technical 
specifications will be treated as license amendments under 10 CFR 
50.90.

IX. Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC)

    A.1  An applicant or licensee who references this appendix shall 
perform and demonstrate conformance with the ITAAC before fuel load. 
With respect to activities subject to an ITAAC, an applicant for a 
license may proceed at its own risk with design and procurement 
activities, and a licensee may proceed at its own risk with design, 
procurement, construction, and preoperational activities, even 
though the NRC may not have found that any particular ITAAC has been 
satisfied.
    2. The licensee who references this appendix shall notify the 
NRC that the required inspections, tests, and analyses in the ITAAC 
have been successfully completed and that the corresponding 
acceptance criteria have been met.
    3. In the event that an activity is subject to an ITAAC, and the 
applicant or licensee who references this appendix has not 
demonstrated that the ITAAC has been satisfied, the applicant or 
licensee may either take corrective actions to successfully complete 
that ITAAC, request an exemption from the ITAAC in accordance with 
Section VIII of this appendix and 10 CFR 52.97(b), or petition for 
rulemaking to amend this appendix by changing the requirements of 
the ITAAC, under 10 CFR 2.802 and 52.97(b). Such rulemaking changes 
to the ITAAC must meet the requirements of paragraph VIII.A.1 of 
this appendix.
    B.1  The NRC shall ensure that the required inspections, tests, 
and analyses in the ITAAC are performed. The NRC shall verify that 
the inspections, tests, and analyses referenced by the licensee have 
been successfully completed and, based solely thereon, find the 
prescribed acceptance criteria have been met. At appropriate 
intervals during construction, the NRC shall

[[Page 27870]]

publish notices of the successful completion of ITAAC in the Federal 
Register.
    2. In accordance with 10 CFR 52.99 and 52.103(g), the Commission 
shall find that the acceptance criteria in the ITAAC for the license 
are met before fuel load.
    3. After the Commission has made the finding required by 10 CFR 
52.103(g), the ITAAC do not, by virtue of their inclusion within the 
DCD, constitute regulatory requirements either for licensees or for 
renewal of the license; except for specific ITAAC, which are the 
subject of a Section 103(a) hearing, their expiration will occur 
upon final Commission action in such proceeding. However, subsequent 
modifications must comply with the Tier 1 and Tier 2 design 
descriptions in the plant-specific DCD unless the licensee has 
complied with the applicable requirements of 10 CFR 52.97 and 
Section VIII of this appendix.

X. Records and Reporting

A. Records

    1. The applicant for this appendix shall maintain a copy of the 
generic DCD that includes all generic changes to Tier 1 and Tier 2. 
The applicant shall maintain the proprietary and safeguards 
information referenced in the generic DCD for the period that this 
appendix may be referenced, as specified in Section VII of this 
appendix.
    2. An applicant or licensee who references this appendix shall 
maintain the plant-specific DCD to accurately reflect both generic 
changes to the generic DCD and plant-specific departures made 
pursuant to Section VIII of this appendix throughout the period of 
application and for the term of the license (including any period of 
renewal).
    3. An applicant or licensee who references this appendix shall 
prepare and maintain written safety evaluations which provide the 
bases for the determinations required by Section VIII of this 
appendix. These evaluations must be retained throughout the period 
of application and for the term of the license (including any period 
of renewal).

B. Reporting

    1. An applicant or licensee who references this appendix shall 
submit a report to the NRC containing a brief description of any 
departures from the plant-specific DCD, including a summary of the 
safety evaluation of each. This report must be filed in accordance 
with the filing requirements applicable to reports in 10 CFR 50.4.
    2. An applicant or licensee who references this appendix shall 
submit updates to its plant-specific DCD, which reflect the generic 
changes to the generic DCD and the plant-specific departures made 
pursuant to Section VIII of this appendix. These updates shall be 
filed in accordance with the filing requirements applicable to final 
safety analysis report updates in 10 CFR 50.4 and 50.71(e).
    3. The reports and updates required by paragraphs B.1 and B.2 of 
this section must be submitted as follows:
    a. On the date that an application for a license referencing 
this appendix is submitted, the application shall include the report 
and any updates to the plant-specific DCD.
    b. During the interval from the date of application to the date 
of issuance of a license, the report and any updates to the plant-
specific DCD must be submitted annually and may be submitted along 
with amendments to the application.
    c. During the interval from the date of issuance of a license to 
the date the Commission makes its findings under 10 CFR 52.103(g), 
the report must be submitted quarterly. Updates to the plant-
specific DCD must be submitted annually.
    d. After the Commission has made its finding under 10 CFR 
52.103(g), reports and updates to the plant-specific DCD may be 
submitted annually or along with updates to the site-specific 
portion of the final safety analysis report for the facility at the 
intervals required by 10 CFR 50.71(e), or at shorter intervals as 
specified in the license.

    Dated at Rockville, Maryland, this 9th day of May, 1997.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-12742 Filed 5-20-97; 8:45 am]
BILLING CODE 7590-01-P