ML20203J437

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Forwards Fr Notice Re Proposed Amends to Commission Regulations for Commercial Npps,Adding New App a to 10CFR52 Which Will When Promulgated Certify Sys 80+ Std Design of ABWR
ML20203J437
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Site: 05200002
Issue date: 04/04/1995
From: Rathbun D
NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA)
To: Faircloth L
SENATE, ENVIRONMENT & PUBLIC WORKS
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ML20203J328 List:
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FOIA-97-384 NUDOCS 9712190206
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. EsseHe01 ,

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April 4, 1995 Honorable Lauch Faircloth, Chairman ubcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works

Dear Mr. Chairman:

The NRC has sent to the Office of the Federal Register for publication the enclosed proposed amendments to the Commission's regulations for commercial nuclear power plants. Specifically, this proposed rule would add a new Appendix A to 10 CFR Part 52 which will when promulgated certify the standard design of the U.S. Advanced Boiling Water Reactor (ABWR) submitted to the NRC for its review by GE Nuclear Energy.

These proposed amendments are necessary to fulfill the objectives of Part 52 which were to provide early resolution of licensing issues and foster standardization while allowing sufficient flexibility to incorporate advancements in-technology and equipment. Those wishing to obtain a license to build or operate a U.S. ABWR will be able to do so by referencing the standard design certified in Appendix A to Part 52.

Sincerely, l .,.& J ,~'-~

Dennis.K. Rathbun, Director .

Office of Congressional Affairs

Enclosure:

Federal Register Notice cc: Senator Bob Grahrm l

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NUCLEAR REGULATORY COPMISSION )

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-10 CFR PART 52 RIN 3150 - AFIS Standard Design Certification for the System 80+ Design )

AGENCY: Nuclear Regulatory Comaission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Comission (NRC or Comission) proposes to approve by rulemaking a standard design certification for the System 80+

design. The applicant for certification of the System 80+ design was Asea Brown Boveri-Combustion Engineering (ABB-CE). The NRC is proposing to add a new appendix to 10 CFR Part 52 for the design certification. This action is necessary so that applicants or licensees intending to construct and operate a System 80+ design may do so by appropriately referencing the proposed appendix. The public is invited to submit coments on this proposed design certification rule (DCR) and the design control document (DCD) that is incorporated by reference into the DCR (refer to Sections IV and V). The Commission also invites the public to submit comments on the environmental assessment for the System 80+ design (refer to Section VI).

DATE: The comment period expires on [ Insert date IZ3 days following the date of publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but the Comission is fgWI Ll>

only able to assure consideration for con-ints received on or before this date. In addition, interested parties may request an informal hearing before the Atomic Safety and Licensing Board Panel, in accordance with 10 CFR 52.51, on matters pertaining to this design certification rulemaking (refer to SectionV). Requests for an informal hearing must be submitted by [ Insert  :

date 120 days following the date of publication in the Federal Register).

ADDRESSES: Mail written comments and requests for an informal hearing to:

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

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

SUPPLEMENTAF,Y INFORMATION:

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l TABLE OF CONTENTS t i I. Background.

II. Public comment summary and resolution.

Topic 1 - Acceptability of a Two-Tiered Design Certification Rule Structure Topic 2 - Acceptability of the Process and Standards for Changing Tier 2 Information Topic 3 - The Acceptability of a Tier 2 Exemption Topic 4 - Acceptability of Using a Change Process, Similar to the One in 10 CFR 50.59 Applicable to Operating Reactors, Prior to the Issuance of a Combined License that References a Certified Design Topic 5 - The Acceptability of Identifying Selected Technical Positions from the FSER as "Unreviewed Safety Questions" that Cannot Be Changed Under a

  • 50.59-Like' Change Procecc Topic 6 - Need for Modifications to 10 CFR~52.63(b)(2) If the Two-Tiered Structure for the Design Certification Rule is Approved Topic 7 - Whether the Commission Should Either Incorporate or Identify the Infomation in Tier 1 or Tier 2 or Both in the Combined License Topic 8 - Acceptability 6f Using Design Snecific Ruiemakings Rather Than Generic Rulemaking for the Technical Issues Whose Resolution Exceeds Current Requirements Topic 9 - The Appropriate Fom and Cnntent of a Design Control Document 111. Section-by-section discussion of design certification rule.

A. Scope.

B. Definitions.

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C. (Reserved).

D. Contents of the design certification.

E. Exemptions and applicable regulations.

F. Issue resolution for the o'esign certification.

G. Duration of the design certification.

H. Change process.

I. Records and reports.

J. Applicability of a DCR in 10 CFR Part 50 licensing proceedings.

IV. Specific requests for comments.

V. Comnents and hearings in the design certification rulemaking.

A. Opportunity to submit written and electronic comments.

B. Opportunity to request hearing.

C. Hearing process.

D. Resolution of issues for the final rulemaking.

E. Access to proprietary information in rulemaking.

F. Ex parte and separation of functions restrictions.

VI. Finding of no significant environmental impact: availability.

VII. Paperwork reduction act statement.

l VIII. Regu'latory analysis.

IX. Regulatory Flexibility Act certification.

X. Backfit analysis.

I. -BACKGROUND On March 30, 1989, Combustion Engineering, Inc. (ABB-CE) applied for certification of the System 80+ standard design with the NRC. The application

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was made in accordance with the procedures specified in 10 CFR Part 50,

. Appendfx'0, and the Policy Statement on Nuclear Power Plant Standardization,-

dated September 15, 1987.

On May_18, 1989 (54 FR 15372), the NRC-added 10 CFR Part 52 to its

- regulations to provide for. the issuance of early site permits, standard design certifications,-and combined licenses for nuclear power reactors. Subpart B of.10 CFR Part 52, established the process for obtaining design certifications. A major purpose of this rule was to achieve early resolution of licensing issues and to enhance the safety and reliability of nuclear power plants.

On August 21, 1989, ABB-CE requested that its application, originally submitted pursuant to 10 CFR Part 50, Appendix 0, be considered as an application for design approval and subsequent design certification pursuant to-10 CFR 52.45. The application was docketed on May 1, 1991, and assigned Docket No.52-002. Correspondence relating to the application prior to this date was also addressed to docket number STN 50-470 and Project No. 675. ABB-CE's application, the Combustion Engineering Standard Safety Analysis Report -

Design Certification (CESSAR-DC) up to and including amendemnt W and the Certified Design Material, is available for inspection and copying at the NRC s- Public Document Room. By letter dated May 26, 1992, Combustion Engineering, Inc. notified the NRC that it is a wholly owned subsidiary of Asea Brown -

Boveri, Inc., and the appropriate abbreviation for the company is ABB-CE.

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

the certification of the System 80+ design in August 1994 (NUREG-1462). The ,

FSERidocuments 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 5

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the scope of the technical details considered in evaluating the proposed design. A copy of the FSER may be obtained from the Superintendent of Documents, U. S. Government Printing Office, Mail Stop SSOP, Washington, DC 20402-9328 or the National Technical Information Service, Springfield, VA-22161. The final design approval (FDA) for.the System 80+ design was issued on July 26, 1994, and published in'the Federal Register on August 2, 1994 (59 FR 39371).

Since the issuance of 10 CFR Part 52, the NRC staff has been working to implement Subpart 8 with issues such as the acceptability of using a two-tiered design certification rule and the level of design detail required for design certification. The NRC staff originally proposed a design certification rule for evolutionary standard plant designs in SECY-92-287,

" Form and Content for a Design Certification Rule." On March 26, 1993, the NRC staff issued SECY-92-287A in which it responded to issues on SECY-92-287, which were put forth by the Commission, and to specific questions raised by Commissioner Curtiss in a letter dated September 9, 1992. Subsequently, the NRC staff modified the draft rule in SECV-92-287 to incorporate Commission guidance and published a draft-proposed design certification rule in the Federal Register on November 3, 1993 (58 FR 58665), as an Advanced Notice of Proposed Rulemaking (ANPR) for public comment. On November 23, 1993, the NRC staff discussed this ANPR in a public workshop entitled " Topics Related to Certification of Evolutionary Light Water Reactor Designs." All holders of operating licenses or construction pemits were informed of the issuance of the.ANPR and the planned public workshop through the issuance of NRC Administrative Letter 93-05 on October 29, 1993. Separate announcements of

, the workshop were also sent to the Union of Concerned Scientists, the Nuclear 6

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Information and Resource Service, the Natural. Resources Defense Council, the Public' Citizen Litigation Group, the Ohio Citizens for Responsible Energy (OCRE), and the State of Illinois Department of Nuclear Safety on October 18, Ifr93. An official transcript of the workshop proceedings is available in she PDR.

Rulemaking Procedures 10 CFR Part 52 provides for Comnission approval of standard designs for nuclear power facilities (f.dl., design certification) through rulemaking. In accordance with the Administrative Procedure Act (APA), Part 52 provides the opportunity for the public to submit written comments on the proposed design certification rule. However, Part 52 goes beyond the requirements of the APA by providing the public with an opportunity to request a hearing before the Atomic Safety and Licensing Board Panel in a design certification rulemaking.

While Part 52 describes a general framework for conducting a design certification rulemaking, 5 52.51(a) states that more detailed procedures for the conduct of each design certification will be specified by the Comuission.

To assist the Commission in developing the detailed rulemaking procedures, the NRC's Office of General Counsel (OGC) prepared a paper, SECY-92-170 (May 8, 1992), which identified issues relevant to design certification rulemaking procedures, and provided OGC's preliminary analyses and reconnendations with respect to those issues. SECY-92-170 was made public by the Connission, and a Comnission meeting on this paper was held ,on June 1, 1992.

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Thereafter, in SECY-92-185 (May 19,1992), OGC-proposed holding a public workshop for the purpose of facilitating public discussion on the issues ,

raised in SECY-92-170 and obtaining public connents on those issues. The Commission approved OGC's proposal (See the May 28, 1992, Memorandum from Samuel J. Chilk to William C. Parler). Notice of the workshop was published in the Federal Register on June 9, 1992 (57 FR 24394). The notice also provided for a 30-day period following the workshop for the public to submit written comments on SECY-92-170. A transcript was kept of the workshop proceedings and placed in the PDR. Nearly 50 non-NRC individuals attended the workshop; an additional eight persons requested copies of SECY-92-170 and workshop materials but did not attend. The workshop was organized in a panel format, with representatives from OCRE (Susan Hiatt), NUMARC (Robert Bishop),

GE and Westinghouse - two design certification vendors (Marcus Rowden and Barton Cowan), the State of Illinois Department of Nuclear Safety (Stephen England), the State 'of New York Public Service Commission (James Brew), the

- Administrative Conference of the United States (William Olmstead), OGC, the NRC staff, and a moderator. Eleven written comments were received after the workshop, three from OCRE (OCRE August 1992 Comments; OCRE September 1992 Letter; OCRE October 1992 Letter), NUMARC, Winston and Strawn, the State of Illinois Department of Nuclear Safety, Westinghouse Energy Systems, the U.S.

Department of Energy, Asea Brown Boveri-Combustion Engineering (ABE-CE), and AECL Technologies 1

. Mr. Rowden submitted an additional comment on behalf of NUMARC which addresses proprietary information.

OGC's final analyses and recommendations for design certification rulemaking procedures were set forth in SECY-92-381 (November 10, 1992). This l

'AECL is the vendor for the CANDU 3 design.

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paper was prepared after consideration of the panel discussions at the public workshop and the written comments received after the workshop. On April 30, 1993, the Commission issued a Memorandum to the General Counsel which sets forth the Comission's determinations with respect to the procedural issues raised by the General Counsel's paper. Section V. below, " Comments and Hearings in the Design Certification Rulemaking," describes the procedures to be utilized in this design certification rulemaking.

II. PUBLIC COPfiENT SUPHARY AND RESOLUTION The public comment period for the ANPR for rulemakings to grant standard design certification for evolutionary light water reactor designs expired on January 3, 1994. Six comment letters were received. Five comment letters were from the nuclear industry (i.e., vendors, utilities, and industry representatives) and one from a public interest organization. Most of tne comenters addressed the nine topics upon which the NRC sought the public's views. The Comission has carefully considered all the coments and wishes to express its sincere appreciation of the often considerable efforts of the  !

comenters.

In the following public comment summary and resolution and in the section-by-section discussion (Section III below), the discussion refers to  ;

l "Comission approval" of NRC staff-proposed positions or recomendations. '

This should be understood as meaning the Comission's tentative approval of those positions or recommendations for purposes of: (1) the NRC staff's review of the System 80+ design certification application, and (ii) preparation of this notice of proposed rulemaking. The public may subait coments and 9

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request an informal hearing with respect to any of the "Comission approved" positions or recommendations (comments and hearings-are discussed in further detail in Section V).

. All of the cossenters supported the basic concept of the design certification rulemaking approach including the two-tiered e+ructure for design information. The Nuclear Management and Resources Council, which has since been subsumed within the Nuclear Energy Institute (NEI), comented for the nuclear industry. GE Nuclear Energy, Westinghouse, and ABB-CE stated that they part'cipated in the preparation of the NEI coments and fully supported them. The following is a sumary and resolution of the public coments:

i Topic 1 - Acceptability of a Two-Tiered Design Certification Rule Structure Coment Sumary. On behalf of the nuclear industry, NEI stated that a uo-tiered structure to a design certification rule is practical and fully consistent with the intent arl requirements of 10 CFR Part 52. OCRE stated that it fully supports the concept set forth in the ANPR provided that the Tier 2 information is subject to public challenge in the standard design certification and any associated hearing.

Response. Although a two-tiered structure for design certification rules was not envisioned or subsequently deemed necessary to implement standard design certifit.ations under 10 CFR Part 52, the Comission approved the use of a two-tiered structure for a design certification rule in its SRM of February 15, 1991, on SECY-90-377, " Requirements for Design Certification Under 10 CFR Part 52," in response to a request from FEI dated August 31, 10

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1990.- Since then, the NRC staff has worked 'to develop a two-tiered rulef that achieves' industry's goal of issue preclusion .for a greater amount of information than was origina11y' planned for_ design certification, while retaining flexibility for design implementation.

-Tier 1 information is defined in Section 2(b) of the proposed rule and

-is treated as the certified information that is controlled by the-change standards of 10 CFR 52.63. Tier 2 information is defined in Section 2(c) of the proposed rule and consists primarily of the information submitted in an

application for design certification. The information in the two tiers is-interdependent. Therefore, an applicant for a construction permit, operating license, or combined license (COL) that references this design certification must reference both tiers of information. The consolidation of both tiers of information into a Design Control Document (DCD) will provide an effective means-of maintaining this information and facilitating its incorporation into the rule by reference. All matters covered in each tier, including the determination of what information should be placed in each tier, are subject to public challenge in the design certification rulemaking and any associated i

. hearing.

Topic 2 - Acceptability of the Process and Standards for Changing Tier 2 Information Comment Summary. NEI concurs in the process and standards to be used by COL holders and applicants for evaluating and implementing changes to Tier 2 information via the so-called "I 50.59-like" change process. However, NEI does not agree with the' statement in the ANPR ( A.13(d)(3)) that " changes-

properly implemented through this "I 50.59-like" process cause a loss of 11 1

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finality relative to the affected port kn of the design or are subject to subsequent legal ' challenge.' NEI contends that these changes would be j sanctioned through-the design certification rule and that the only issue entertalnable at the time of the COL licensing proceeding would be_ whether the i licensee complied with the 'l 50.59-like' change process. Likewise, changes l

-i made subsequent to COL issuance could be challenged in the Part 52_ proceeding before fuel-loed authorization only on the basis that the change resulted in f i

However, NEI recognizes i noncompliance with applicable acceptance criteria.

that changes from Tier 2 that require NRC approval would be subject to a hearing opportunity as specified in 10 CFR Part 52.

DCpE-stated that it is important that applicant or licensee initiated changes to Tier 2 information made pursuant to the l 50.5g-like" process will l

' i no longer be afforded the issue preclusion protection of 10 CFR 52.63. To do otherwise would turn the two-tiered system into a double standard in which utilities could deviate from the standard design but the public could not  ;

i challenge these deviations. Pemitting site-specific litigation of these  !

changes would also serve to discourage changes.

Itasoonse. In order to implement the two-tiered structure for design  !

I certification rules, the Commission proposes a change process for Tisr 2 information that has the same eleen ts as tbs Tier 1 ch mge process.

Specifically, the Tier 2 change process has provisions for generic changes, plant-specific changes, and exemptions similar to those in 10 CFR 52.63. ,

I Although the NRC staff proposed that the backfitting standards for making generic changes to Tier 2_ infomation should be less stringent than those for Tier 1 information, the :ommission disapprovsd-this proposal in its SRM on I SECY-92-287A, dated June 13, 1993 and stated that *the backfitting standards 12 j 4

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of 10 CFR 52.63 should be applied for such changes to Tier 2.' As a result, th; NRC staff adopted the backfitting standards of 10 CFR 52.63 in the Tier 2  ;

change process proposed in the ANPR, except that the additional factor regarding 'any decrease in safety that may result from the reduction in standardization" was not adopted for plant-specific changes and exemptions in order to achieve additional flexibility for Tier 2 information.  :

The Tier 2 char;ge process also has a provision similar to 10 CFR 50.59 that allows changes to Tier 2 information by an applicant or licensee, without prior NRC approval, subject to certain restrictions. The Commission approved this process in its SRM on SECY-90-377, dated February 15, 1991, provided -

"that such changes open the possibility for challenge in a hearing." The NRC staff followed the Commission's guidance in developing the process in ANPR A.13(d)(3) that allows certain changes to Tier 2 information, without prior NRC approval. This section of the ANPR states that ' Tier 2 changes will no longer be considered matters resolved in connection with the issuance or renewal of a design certification within the meaning of 10 CFR 52.63(a)(4)."

The NRC staff included this provision to meet Commission guidance and to restrain Tier 2 changes in order to maintain the benefits of standardization, as discussed in SECY-92-287. Also, changes may be challenged in individual COL proceedings since the changes depart from the design infomation approved in the design certification rulemaking. Therefore, the NRC Commission agrees with the OCRE position on issue preclusion and specifically invites coments on this provision (See Section IV).

Topic 3 - The Acceptability of a Tier 2 Exemption 13 i

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(amment_Summarv, NE! supports the inclusion of the provision that an applicant or licensee may request, and the NRC may grant, an exemption to Tier 2 information. OCRE indirectly supports the Tier 2 exemption provision but recommends that the 'entence "These Tier 2 changes will no longer be considered matters resolved in conn 6ction with the issuance or renewal of a design certification within the meaning of 10 CFR 52.63(a)(4)." also be included in the Section A.13(d)(2) of the ANPR on exemptions from Tier 2 information, for clarity, and because 10 CFR 52.63(b)(1) does not mention the two-tiered system.

Response in SECY-92-287A, the NRC staff proposed the addition of an exemption provision to the Tier 2 change process so that the change process for both tiers would have the same elements and to provide additional flexibility to applicants or licensces that reference a design certification rule. The Commission deferred its decision on an exemption to the Tier 2 change process in its SRM dated June 23, 1993, and requested the NRC staff to solicit public coments on this issue.

Because no commenter objected to the addition of a Tier 1 exemption process and NEI supported the proposal, the provision was retv.ned in the proposed rule. However, OCRE proposed that Tier 2 exemptions lose issue preclusion consistent with Tier 1 exemptions. Because that is consistent with the NRC staff's approach to Tier 2 changes and the Comission's guidance in its SRM on SECY-90-377 (sts response to topic #2), OCRE's proposal has been incorporated into the proposed rule.

The additional standard in the Tier 1 exemption process, which requires that "any decrease in safety that may result from the reduction in standardization caused by tha exemption

  • outweighs the special circumstances 14

in 10 CFR 50.12, was not included in the Tier 2 exemption process because the Commissioa views Tier 7 information as more detailed descriptions of Tier 1 information that should have a less stringent change standard than Tier 1 and the industry requested additional flexibility for Tier 2 information.

Therefore, the proposed Tier 2 change process uses the same standard that is used for Part 50 exemptions, namely 10 CFR 50.12. The Commission believes that the loss of issue preclusion for Tier 2 exemptions will help minimize the consequences of the loss of standardization caused by these exemptions.

Topic 4 - Acceptability of Using a Change Process, Similar to the One in 10 CFR 50.59 Applicable to Operating Reactors, Prior to the issuance of a Combined License that References a Certified Design Comment Summarv. NE! concurs in the NRC's proposal to have the

'l 50.59-like" change process apply to both COL applicants and licensees.

Response. in its SRM on SECY-92-287A, dated June 23, 1993, the Commission approved the NRC staff's proposal to extend the use of the "I 50.59-like" change process for Tier 2 information to applicants that reference a certified design. Because NEl and other commen'sers supported this proposal, this additional flexibility his been retained for the proposed rule.

Topic 5 - The Acceptability of Identifying Selected Technical Positions

' from the FSER as "Unreviewed Safety Questions' that Cannot Be Changed Under a "Section 50.59-Like' Change Process Comment Summary. NE! commented that the proposal to predesignate changes to certain design aspects as constituting "unreviewed safety 15

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questions

  • Is unnecessary and is tantamount to the creation of a third tier of ,

information, which runs counter to the two-tier structure. NEl proposed that the selected Tier 2 material be designated, not broadly in the rule, but I specifically in the SSAR/FSER and the DCD as requiring NRC staff notification ,

before implementing the changes. NE! argued that at the time of notification, 1 the NRC staff could decide wh-ther the proposed change constitutes an i

'unreviewed safety question," and the applicant or COL holder would be prohibited from making the change without either NRC staff concurrence or a ,

successful appeal of the NRC staff's detemination. NE! also envisioned a time, subsequent to completion of designs and the inspections, tests, ,

analyses, and acceptance criteria (ITACC), when the change restriction for selected Tier 2 material will no longer be necessary. NE! further stated that, whether or not the Commission adopts NEI's proposal, the NRC staff ,

should be limited to design areas discussed with plant designers when designations of "unreviewed safety questions" are made. Also, these special designations should be as narrow and specific as practicable to avoid the ,

inadvertent broadening of this special category of Tier 2 design information and the excessive restrictions against change that would result.

Resnonse. The NRC's proposal to predesignate certain Tier 2 information that cannot be changed without prior NRC approval does not create a third tier of information or conflict with the two-tiered rule structure. In fact, this so-called Tier 2* infomation was created as a consequence of industry's implementation of the two-tiered rule structure. Specifically, industry's desire to minimize the amount of information in Tier 1 and to use design acceptance criteria in lieu of design information in certain areas resulted in the need to identify significant Tier 2 infomation that could not be changed 16

by an applicant or licensee without prior NRC approval. The previous  ;

I reference to ' identified unreviewed safety questions

  • in the ANPR was made to indicate that the process for changing the so-called Tier 2* information would be the same as for changing other Tier 2 information that an applicant or licensee detemines to constitute an unreviewed safety question. Therefore, there is no third tier of infonsation. Rather, some Tier 2 information cannot  ;

be changed without prier NRC approval and the remainder can. This is no different than the infomation in a Final Safety Analysis Report relative to the process in 10 CFR 50.5g.

The Commission agrees with NEI that it would be clearer to future users of the certified design if the specific information that has been designated as requiring prior NRC approval (Tier 2*) is identified in the DCD rather than sum 3arized in the design certification rule (DCR). However, the requirement for prior NRC approval da.t1 need to be specified in the DCR for the Tier 2 change process. Therefore, the NRC instructed the applicants to identify the Tier 2* information in the DCD.

In response to NEI's request the DCR will not identify the Tier 2*

information as an unreviewed safety question because that designation is not required; only prior NRC approval is required. Therefore, the Tier 2 change process has been revised to state that Tier 2* information identified in the DCD cannot be changed without prior NRC approval. Although Tier 2* changes may not result in unreviewed safety questions, the public will be afforded an opportunity to challenge the changes (see response to topic #2). The Commission also agrees that the predesignation of Anat of the Tier 2*

information can expire when the plant first achieves 100% power while other Tier 2* infomation must remain in effect throughout the life of the plant 17

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t that references the DCR. This is because there is sufficient information in  ;

some of the related areas of Tier 1 to control changes after the plant is ,

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

The NEI proposal to require notification of the NRC rather than requiring NRC approval prior to changing the Tier 2* information would create an unnecessary purden on the NRC in the Tier 2 change process. The Commission has already determined that the predesignated Tier 2* information is significant and cannot be changed before NRC approval. Therefore, the Commission has not acepted the " notification' proposal. Also, the designation ,

-of Tier 2* information is not an excessive restriction on the change process.

Rather, it compensates for industry's request to minimize the amount of information in Tier 1.-

Topic 6 - Need for Nodifications to 10 CFR 52.63(b)(2) If the Two-Tiered Structure for the Design Certification Rule is Approved i

Comment Summary. OCRE commented that modifications to i 52.63 are not necessary because the design certification rules would also become regulations. NEI commented that changes to 10 CFR Part 52 are not needed at this time but that some changes to Part 52 may be identified as appropriate for future consideration based on experience with the initial design certifications.

Resoonse. When Part 52 was written, I L2.63(b)(2) was intended to be the change process for information that was not referenced in the design certification rule (non-certified information). Now that the Commission has i ' decided to implement a- two-tiered rule structure as described in the response i .

to Topic #1, the two-tiered change process applies to all information 18

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l referenced by the design certification rule. Therefore, there does not appear to be a need for i 52.63(b)(2) in a two-tiered rule structure.

In the absence of any perceived need for changes to 10 CFR 52.63(b)(2) l to accommodate the two-tiered concept in design certification, the Commission j does not intend to modify 10 CFR Part 52 at this time. However, as NE!

suggests, the Commission is evaluating the 'need for changes tc Part 52 as it gains experience with the initial design certification reviews.

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- Topic 7 - Whether the Commission Should Either Incorporate or Identify {

the Information in Tier 1 or Tier 2 or Both in the Combined License Comment Summarv. On the question of whether Tier 1 or Tier 2  !

information should be incorporated in the combined license (COL) or identified

! In the COL, NEl stated that this question need not be resolved for design certification purposed but provides two alternatives for future NRC consideration. Alternative one would be to incorporate Tier 1 information and  !

identify Tier 2 information in the COL. The second alternative would be to incorporate both tiers of information.in the-rule, provided that the Tier 2 change provisions are incorporated in the rule as well.

OCRE stated that both Tier 1 and Tier 2 information should be incorporated in the COL because both tiers contain important design inforst. tion.

Resocnse. The NRC is deferring the decision on this issue because resolution of this issue is not needed to develop a design certification rule.  ;

However, because the commenters all supported incorporation of both tiers of information, the NRC staff will evaluate that option for a combined license =

under Subpkrt C of 10 CFR Part 52.

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.i Topic 8 - Acceptability of Using Design Specific Rulemakings Rather Than Generic Rulemaking for the Technical issues Whose Resolution Exceeds Current Requirements C= nt 5"-= ry. NEl, GE Nuclear Energy, and Westinghouse Electric i Corporation took exception with the NRC position on the issue of designating severe accident and technical requirements, beyond those in current regulations, as " applicable regulations" in the design certifiestion rule.  ;

NEl stated that "Comission approved NRC staff positions will be reflected in a design certification rule by means of design previsions contained in Tier 1 and Tier 2 of the DCD incorporated in the rule." NE! argued that the NRC staff's proposed approach would result in needless duplication, complexity, and delay because matters that have been agreed to in detail would then be formulated in broadly stated positions requiring another round of extensive discussions to reach agreewnt in a process equivalent to a series of complex, discrete rulemakings. In addition, NE! stated that these " broadly stated, free standing applicable regulations carry the potential for new and diverse interpretations by the NRC staff during the life of the design certification."

These interpretations may be at odds with the understandings that translated into specific Tier 1 and Tier 2 requirements in the DCD. GE Nuclear Energy reiterated these coments but added that 'The course proposed by the NRC staff would enormously complicate pre-rulemaking preparation, the conduct of the rulemakings themselves and COL licensing and pos6-licensing facility construction and operation. It would, moreover, impose schedule delays and 9enerate needless duplication, if not outright conflicts." Also, NE! saw little difference between the proposal to incorporate applicable regulations 20

in design certification rules and the similar effect of proceeding with generic severe accident rulemaking.

DCRE stated that the resolution of technical issues whose resolution exceeds current requirements will likely be design-specific and therefore, it may make little difference whether the rulemakings are design-specific or generic. OCRE further stated that, if the NRC wants all plants constructed af me a certain date to incorporate certain design faatures or otherwise address certain technical issues, then a generic rulemaking may be the safest and most cost-effective way to accomplish this goal. OCRE also noted that a generic rule would cover an applicant that might decide not to use a standard certified design.

Resnonse. The Commission has used design-specific rulemaking rather than generic rulemaking for the selected technical and severe accident issues that go beyond current requirements for light-water reactors (LWRs). The Commission adopted this approach, early in the review process, because it believed that the new requirements would be design-specific, as DCRE stated.

Also, the NRC was concerned that generic rulemakings would cause significant delay in the design certification reviews. The Commission approved this approach in its SRM on SECY-91-262, dated January 28, 1992, and has continued to support this approach for evolutionary LWRs, as stated in its SRM on SECY-93-226, dated September 14, 1993. The Commission has deferred its decision on the need for generic rulemaking for advanced LWRs.

Both the industry and DCRE concluded that there would be little difference in the requirements for the certified designs, regardless if the approach was generic or design-specific. The Commission agrees that at the conclusion of the design certification rulemaking the effect of the new 21 l

l

_ _ , . , . . . ~ . . . . _ . . . _ _ . . _ . - _ . . . . . . _ , ,,

regulations is basically the same but that the specific wording of the regulations ma nave ber 'ferent if generic rulemaking was used.

In imples ing t .ls of 10 CFR Part 52 and the Commission's Severt Accident Policy . ' atomer, 50 FR 32138; August 8,1985), the NRC staff set o- ,

to achieve a higner level of safety performance for both evolutionary and passive LWR designs in the area of severe accidents and in other selected areas. The NRC staff proposed new requirements to implement these goals in various Coinnission papers, such as SECY-90-016 and SECY-93-087. The NRC staff then selected the applicable requirements for each evolutionary design and evaluated the design information that describes how those requirements were met in the FSERs for the U.S. ABWR and System 80+ designs. In the proposed rule for each design, the NRC has identified these requirements as applicable regulations in order to specify the requirements that were applicable and in effect at the time the certification was issued for the purposes of 66 52.48, 52.54, 52.59, and $2.63.

These applicable regulations, which were identified in each FSER, are set forth in the design certification rule, with minor editing, to achieve codification through the design certification rulemaking. These codified regulations, which supplement the list of regulations in i 52.48, t.ecome part of the Commission's regulations that are ' applicable and in effect at the time the certification was issued." Without this complete list of applicable regulations, the NRC staff could not perform reviews in accordance with il 52.59 and 52.63. By codifying these requirements, the NRC intends to make it clear that for the purpose of renewal of a certified design under i 52.59, these requirements are part of the applicable regulations in effect at the time that the design certification was first issued. The NRC also intends to 22

. . . _ _ -- - . _ . = . _ . - - _ _ . -

9 make it clear that the Comission may, pursuant to i 52.63(a)(1) and (3), i impose modification of Tier 1 information or to issue a plant-specific order, respectively, to ensure that the certified design or the plant complies with the applicable regulations of the design certification rule. The rationale is that the Commission could not, without re-reviewing the merits of each

~

position, impose a change to Tier 1 information or issue a plant-specific order merely because the modification was necessary for compliance with a matter involving these proposed requirements. Also, the Connission would not have a complete baseline of regulations for evaluating p oposed changes from the public, applicants, or licensees, thereby degrading the predictability of the licensing process.

The codification of these proposed requirements, in reference to i 52.48, is also necessary for two other reasons. First, it serves as a basis for obtaining public comment on the proposed adoption of the requirements as applicable regulations. Second, it provides confirmation that the requirements are being adopted by the Comission as applicable regulations under i 52.54 for the design certification being approved, In the absence of this codification, a design certification applicant could argue that the Comission cannot lawfully condition approval of the design certification on compliance with the proposed requirements used during its review of the design. This is because the requirements are not " applicable standards and requirements of the ... Comission's regulations" without further Comission action under i 52.54.

By identifying the regulations that are applicable to each design, tha Connission has improved the stability and predictability of the licensing process. By approving the design information that describes how these 23 l

I regulations were met, the Commission has minimized the potential for a ,

differing interpretation of the regulations, finally, the NRC staff told NEI in a meeting on April 25, 1994, and in a letter dated July 25, 1994, that the ,

industry-proposed alternative to applicable regulations was unacceptable. The NRC staff stated that design information cannot function as a surrogate for design-specific (applicable) regulations because this information describes ,

only one method for meeting the regulation and would not provide a basis for evaluating proposed changes to the design information. Therefore, consideration of the comraents on Topic #8 has not altered the Commission's decision to proceed with design-specific rulemaking for the proposed requirements and to publish the appropriate applicable regulations in each design certification rule.

Topic 9 - The Appropriate Form and Content of a Design Control Document.

Comment Summary. Concerning the form and content of the DCD, NEl envisioned a document that consisted of three parts including an introductory section Tier 1 information, and Tier 2 information. NE1 also proposed an algorithm that described the industry's view of the contents of a DCD.

NEl stated that, based on its interactions with the NRC staff on the guidance for preparing a DCD, two main issues have emerged. The first issue is the nature and treatment for rulemaking purposes of secondary references contained in the DCD. At issue is the extent to which references to codes, standards, Regulatory Guides, etc. need to be explicitly " incorporated by reference" in specific design certilication rules (DCRs). It is industry's position that the burden of incorporating these secondary references into the rule would outweigh the increase in regulatory certainty and predictability 24

that such an effort would provide. The second issue relates to the regulatory ,

significance of information contained in the DCD and, in particular, design Probabilistic Risk Assessment (PRA) information. Specifically, NE! is concerned with the inclusion of the design PRA in the DCD and a pert.eived requirement to use the PRA to support the '50.59-like' change process.

Resnonse. As defined in SECY-92-287, the DCD is the master document  ;

that contains the Tier 1 and 2 information referenced by the design certification rule. The NRC staff has had several meetings with the design certification applicants on the preparation of a DC3 and provided guidance to the applicants in letters dated August 26, 1993; August J and 5, 1994; and October 4, 1994. Although the Commission agrees with NEl on the basic form of the DCD, it.does not agree with NEI's proposed algorithm on the contents of a DCD.

Because the DCD is the master reference document, it thould, to the extent possible, retain as much of the applicant's standard safety analysis report (SSAR), as required in 10 CFR 52.47. Due to the requirement that all information incorporated in the rule be publicly available, proprietary and safeguards information cannot be includti in the DCD. Also, the NRC concluded that the detailed methodology and quantitative portions of the design PRA do not need to be included in the DCD but the assumptions, insights, and discussions of PRA analyses must be retained in the DCD. The NRC also decided that COL applicants and licensees will be encouraged, but not required, to use the PRA to support the change process. This position was predicated in part upon NEI's acceptance, in conceptual form, of a future generic rulemaking that requires a COL applicant or holder to have a plant-specific PRA that updates and supersedes the design PRA to account for site-specific and detailed as-25

+;

built aspects of the plant. The Commission approved the requirement for a ,

i plant-specific PRA in its SRM on SECY-94-182, "Probabilistic Risk Assessment (PRA) Beyond Design Certification," in approving the development of a generic

' Operational Rule' that would apply to all COL applicants and holders. The remainder of the applicant's SSAR, including all of the assumptions, issue resolutions, and safety analyses, should be retaine.1 in the DCD.

With regard to NEl's concern with secondary references, the NRC staff met with NE! on January 6,1994, and issued a letter to NEI on May 3,1994, that documented an agreement with the industry on the resolution of this issue. The agreement states that combined license (COL) applicants and licensees who reference a DCR will treat these secondary references as requirements, in the context that they are described in the documents referenced in the DCD. However, these secondary references will not be incorporated by reference in the DCR, at.d thus there is no issue preclusion for secondary references. With the above ststed guidance, the NRC believes that the appropriate form and content of a DCD has been defined.

Ill. SECTION-BY-SECTION DISCUSSION OF DESIGN CERTIFICATION RULE Pursuant to 10 CFR Part 52, Subpart B, the NRC hat; been working for some time to develop a rule that will achieve the Commission's goals for standard design certifications. Therefore, this proposed rule seeks to achieve the early resolution of safety issues and to enhance the safety and reliability of nuclear power plants. The Commission also expects to achieve a more predictable and stable licensing process through the certification of standard designs by rulemaking. An applicant for a combined license (COL) that 26

references a design certificattois rule (DCR) must meet the requirements in the  !

DCR and in the design control document that is incorporated by reference in the DCR.

The NRC staff's first proposal of a standard design certification rule was provided in Entlosure 1 to SECY-92-287. dated August 18. 1992. This

  • proposal was modified based on Comission guidance, and an updated version was published in Appendix 2 to the ANPR. The proposed rule in this Federal Register notice has the same basic form and content as the ANPR version, but there has been some reorganization of the contents. The following discusses the purpose and key aspects of each section of the rule and also discusses issues raised on those sections that are not covered in the public coment s umary. Changes made to the ANPR version of the proposed rule for the sake of clarity, brevity, consisttncy, or organization are not discussed below.

All references to the proposed rule are to the provisions in proposed Appendix B to 10 CFR Part 52.

A. Scope The purpose of Section 1 of the proposed rule entitled, " Scope,' is to identify the standard plant design that is to be approved by this design certification rule. The applicant for certification of the design is also identifie:i in this section. While the design certift:ation applicant does not have special rightc pursuant to this rule, the implementation of 10 CFR 52.63(c) depends on whether an applicant for a COL contracts with the design certification applicant to provide the certified design. If the COL applicant necessary to implement this rule.

27

1 Because the requirements of 10 CtR 52.63(c) apply to an applicant for a COL, the NRC proposes that this requirement be added to 10 CFR Part 52, Subpart C, specifically to a new Section 10 CFR 52.79(e). The NRC requests comments on the desirability of making this change to 10 CFR Part 52 (refer to SectionIV).

B. Definitions The terms Tier 1 Tier 2, and Tier 2* are defined in Section 2 of the proposed rule entitled.

  • Definitions," because these concepts were not .

envisioned at the time that 10 CFR Part 52 was developed. The design certification applicants and the NRC used these terms in implementing the two-tiered rule structure that was proposed by industry after the issuance of Part 52 (refer to discussion on Topic #1). The design control document (DCD) contains both the Tier 1 and 2 information, along with an introduction. After the issuance of the ANPR, the phrase Tier 2* was added to the list of definitions. Some of the information in Tier 2 that requires special treatment in the change process and was commonly referred to as Tier 2* during the design review. Therefore, the Commission believes that it would be useful to define and use this phrase in the proposed rule. Further information on changes to or departures from information in the DCD is provided below in the discussica on Section 8, " Change Process." The NRC requests suggestions on other words or phrases that may need to be defined in this rule (refer to Section IV).

28

i t

C.[ Reserved]  :

The purpose of Section 3 "Information collection requirements," in the proposed rule was originally intended to provide the citation for the control number which has been assigned by the Office of Hanagement and Budget when it approved the information collection requirements in this rulemaking. Because this citation has been placed in i 52.8, Section 3 to the rule is no longer necessary.

D. Contents of the design certification Section 4 of the proposed rule entitled, " Contents of the design certification," identifies the design-related information that is incorporated by reference into this rule (4(a)) and includes some related provisions of the proposed rule (4(b) and (c)). Both tiers of design-related information have been combined into a single document, called the design control document (DCD), in order to effectively contrcl this information and facilitate its incorporation into the rule by reference (refer to Topic #9 for discussion on the DCD). The DCD was prepared to meet the requirements of the Office of the Federal Register (OFR) for incorporation by reference (1 CFR Part 51).

Section 4(a) of this proposed rule would incorporate the DCD by reference upon approval of the Director, OFR. The legal effect of incorporation by reference is that the material is treated as if it were published in the Federal Register. This material, like any other properly issued regulation, has the force and effect of law.

29 l

4 4

An applicant for a construction pemit or COL that references this design certification rule must confom with the requirements in the proposed rule and the DCD. The master DCD for this design certification will be archived at NRC's central file with a matthing copy at OFR. Copies of the up- ,

to-date DCD will also be maintained at the %C's Public Document Room and Library. Questions concerning the accuracy of infomation in an application that references this design certification will be resolved by checking the master DCD in NRC's central file. If a generic change (rulemaking) is made to the DCD pursuant to the change process in Sec. tion 3 of the proposed rule, then at the completion of the rulemaking the NRC will change its copies of the DCD l and notify the OFR and design certification applicant to change their copies.

The applicant for this design certifit.ation rule is responsible for preparing the DCD in accordance with NRC and OfR requirements and maintaining an up-to-date copy pursuant to Section 9(a)(1) of the proposed rule. Plant-specific changes to and departures from the DCD will be maintained by the f

applicant or licensee that references this design certification rursuant to Section 9(a)(2) of the proposed rule. In order to meet the requirements of 0FR for incorporation by reference, the originator of the DCD (design i

certification applicar.t) must make the document available upon request after the final design certification rule is issued. Therefore, the proposed rule states that copies of the DCD can be obtained from the applicant or an organization designated by the applicant. The applicant for this design certification has stated that it may request distribution of its DCD by the .

National Technical Infomation Service (NTIS). If the applicant selects an organization, such as NTIS, to distribute the DCD, then the applicant must ,

I l

30

. _ . _, - , - - ~ _ . - - , _ . - - _ _ _ . _ . _ . .

l i

provide that organization with an up-to-date copy. A copy of the DCD must  !

also be made available at the NRC and 0FR. l 5

The DCD contains an introduction that explains the purpose and uses of the DCD and two tiers of design-related informacion. The significance of designating design information as Tier 1 or Tier 2 is that differer't change processes and criteria apply to each tier, as exp hined below in Section H.

" Change process. The introduction to the DCD is neither Tier I nor Tier 2 l information, and is not part of the information in the DC0 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 beteren ,

the explanations in the DCD introduction and the explanations of this design  !

certification rule in these statements of consideration (SOC), then this 500 l

is controlling.

The Tier 1 portion of the design-related information contained in the L

DCD is certified by this rule. This information consists of an introduction  :

l to Tier 1, the certified design descriptions and corresponding inspections, ,

tests, analyses. and acceptance criteria (ITAAC) for system and structures of the design, desigo material applicable to multiple systems of the design, significant interface requirements, and significant site parameters for the .

design. The NRC staff's evaluation of the Tier 1 information, including a description of how this information was developed is provided in Section 14.3 of the FSER.

c The.information in the Tier 1 portion of the DCD was extractsd from the detailed information contained in the application for design certification.

The Tier 1 information addresses the most saftty-significant aspects of the 31

. ...-..,-.......-,,.,,-,m.,,-.mm._e.,., .,_,,~.i .,r.. .m... ,y .. .. .__ -. --......,~.._.~..,

l

. H l

design, and was organized primarily according to the structures and. systems of }

the design. Additional design materin1 and related ITAAC is also provided in l Tier 1 for selected design and construction activities that are applicable to l l

multiple systems of the design. The Tier I design descript10ns serve as l design connitments fer t%6 lifetime of a facility referencing the design _

]

tertification, and the ITAAC verify that the as-built facility conforms with the approved design and applicable regulations. In accordance with 10 CFR j ;

$2.103(g), the Commission must find that the acceptance criteria in the ITAAC l are met b9 fore operation. After the Coselssion has made the finding required by 10 CFR 52.103(g), the ITAAC do not constitute regulatory requirements for j subsequent modifications. However, subsequent modifications to the facility j l

must comply with the Tier 1 design descriptions, unless changes are made in j

necordance with the change process in Section 8 of this proposed rule.

The Tier 1 interface requirements are the most significant of the j interface requirements for the standard design, which were submitted in <

. response to 10 CFR 52.47(a)(1)(vii), that must be met by the site-specific [

portions of a facility that references the clesign ' certification. The Tier 1 site parameters are the most signifirant site parameters, which were submitted in response to 10 CFR 52.47(a)(1)(iii), that must_ba addressed as part of the application for a construction permii or COL. [

t Tier 7 is the rSrtion of-the design-related information contained in the D00 that is approved by this rule but is not certified. The change process  ;

defines the procedbral differences beteen Tier 1 and 2. Changes to or i departures from the certified design natuial (Tier 1) must comply with-  !

Section 8(a)__of this proposed rule. Changes to a departures from the i approved information (Tier 2) must comply with Section 8(b) of this proposed

+

32- .

-i

. . . . . . . . ,..J-..-.. ..~_._;-.._._.-_._..._ c__.-.._-__--.._- . _ , . _ , . - . . , , . _ _ _ - . . _ _ . . ~ m :,,_ , - . , ,...s

'd rule. Tier / includes the information required by 10 CFR 52.47 and supporting information on the inspectinns, tests, and analyses that will be performed to demonstrate that the acceptance criteria in the ITAAC have been r.et.

Compliance with the more detailed lier 2 information provides a sufficient method, but not the only acceptable method, for complying with the more general design requirements included in Tier 1. A supplementary description f

of Tier 2 information is provided in the DCD introduction. If an applicaat or licensee used methods other than those described ir.'fier 2, ther, the alternative method would be open to staff review and a possible subject for a hearing.

When completing the design information for a plant, an applicant for a CDL must conform with all of the requirements in the DCD, unless the information in the DCD is changed pursuant tc the process in Section 8 of this proposed rule. Accordingly, an applicant for a construction permit or COL, or licensee that references this certified design must conform with all of the requirements from the DCD, including the codes, standards, and other guidance docuinents that are referenced from the DCD (so-called secondary references).

The industry agreed to treat these secondary references as requirements even though they are not incorporated by reference, in the context as described in the DCD, as set forth in a letter from Dennis Crutchfield of the NRC to Joe Colvin of the Nuclear Energy Institute, dated May 3, 1994.

An applicant for a construction permit or COL that references this '

proposed rule must also describe those portions of the plant design which are site-specific, and demonstrate compliance with the interface requirements, as required by 10 CFR 52.79(b). The COL applicant does not need to confor.n with the co,Mytual design information in the DCD that was provided by the design l

1 33 l

\

1

  • certification applicant in response to 10 CFR ft.47(a)(1)(ix). The conceptual f deilgn infomation, which are examples of site-specific design features, was  ;

>- required to facilitate the design certification review, and it is neither l'or i 1 nor 2. The introduction to the DCD identifies the location of the conceptual design information and explains that this infomation is not ~

applicable to a COL application.  !

An appilcant must' address COL Action Items, which are identified in the

. DCD as COL License Infomation, in-its COL application. The COL Action Items

- (COL License Infomation) identify matters that need to be addressed i./ an applicant or licensee that references the design certification, as required by [

10 CFR 52.77 and 52.79. A further explar.ation of the status of the COL 7 License Information is provided in the DCD introduction. Also, the detailed 1

methodology and quantitative portions of the design-soecific probabilistic ,

1 risk assessment (PRA), as required by 10 CFR 52.47(a)(1)(v), was not included in-the.DCD. The NRC agreed with the design certification applicant's request to delete this infomation because conformance with the deleted portions of f the PRA is not required. The Commission's position is also predicated in part upon NEI's acceptance, in conceptual fom, of a future generic rulemaking that requires a COL cpplicant or licensee to have a plant-specific PRA that updates and supersedes the design-specific PRA and maintain it throughout the operational life of the plant.

The application for dvsign certification contained proprietary and j safeguards information. This information was part of the NRC staff's bases for.its safety findings in the.FSER. The proprietary information, or its-equivalent.-that was provided in the design certification application by 1

reference but not included in the DCD, must be included as part of a COL  !

34 b

1 U w -ew. , +%'.+=we,'-we.-

,ae.,w..w,.,.-,,,wmore,_-,w.,e '-w,-.- ,,,,-c._.,heww w-mmy-,,.,. w m - + ,w-w mvpap. , c or e, a 3 -pg e y e v + -e-+ w c.- wsyn,.e-- g-2v.-=r

application. 'The Commission considers this information to be requirements for i

plants that reference this rule. Since the proprietary information was not  !

included in the DCD, or otherwise approved by 0FR for incorporation by I reference, it would not have issue preclusion in a construction permit or COL I proceeding. l There is other infomation that is within the scope of the certified  !

design (i.e., as-built, as-procured, and evolving technology design information) that must be developed by a COL applicant or holder. This  !

detailed design information must be completed in accord nce with the requirements in the DCD and the acceptance criteria in ITAAC, including design i acceptance criteria (DAC). Since the Tier 1 and 2 infomation is solely contained within the DCD, the risainder of the design-rciated information that fs developed by a COL applicant or holder that references this proposed rule will not be r,ither Tier 1 or 2 infomation, whether it is within the scope of the design ctrtification or not. Therefore, the change process in Section 8 of this proposed rule will not control this COL information. Although the change process for this COL inicreation does not need to be developed until a COL application is submitted, the Commission is interested in the public's view on how this information should be controlled (refer to Section IV).

The purpose of Section 4(b) of this proposed rule is to ensure that an applicant that references this design certification references both tiers of infomation in the DCD. The two tieis of information were developed together and both tiers of infomation are needed to complete the design of a plant that references the rule. For example, the ITAAC in Tier I contains not only the acceptance criteria for verifying that the as-built plant confom2 with the approved design, but it also contains various design processes with 35 i

i

I acceptance criteria (DAC), for completi.eg selected areas of the plant design. l The DAC are described in Section 14.3 of the SSAR and FSER. The NRC staff f i

relied on DAC for its evaluation of selected design areas wnere the. applicant l l

for design certification did not provide complete design infersation. Also,  ;

I the Tier 2 information contains explanations and procedures on how to j implement ITAAC. Therefore, the Commission proposes that an aps.1fcant could

' not reference this design certification rule without meeting ITAAC, even r

] though it is not a requirement in 10 CFR Part 50. (ste Section J for further  :

- discussion)

The applicant for design certification initially prepared the DCD to be consistent with the SSAR and the NRC staff's FSER. The applicant for design certification made some corrections and clarifications to the DCD since the completion of the SSAR and issuance of the FSER. If there is an inconsistency between the $$AR and the FSER, or between either of these documents and the DCD, then the DCD is the controlling document. That is the purpose of Section 4(c) of this proposed rule. .

k E. Exemptions and applicable regulations ,

The purpose of Section 5 of the proposed rule entitled, ' Exemptions and P hpplicable regulations," is to identify the complete set of regulations that [

were applicable and in effect at the time the design certification was issued

. for the purposps of 10 CFR-52.48, 52,54, 52.59, and 52.63. In accordance with 10 CFE 52.48, the NRC staff used-the technically relevant regulations (safety - -

standards) in 10 CFR Parts 20, 50, 73, and 100 in performing its review of the

application for design certification. The effective date of these applicable 36 r e r .- w - m m - , - - se er - --
  • e s - ee .*a , ,e-ae-s - m--s-.-e meme n Cwe^ eve +-er~e---e%---e-we- mW-~ -e w

regulations is the date of the FSER, as set forth in Section 5(b) of the i

proposed rule. During its review of the application for design certification, the NRC staff identified certain regulations for which application of the regulation to the standard design would not serve or was not necessary to achieve the underlying purpose of the regulatien. These proposed exemptions to the NRC's current regulations are identified in Section 5(a) of this i proposed rule. The basis for these exemptions is provided in the FSER.

In implementing the goals of 10 CFR Part 52 and the Commission's Severe Accident Policy Statement, the NRC staff set out to achieve a hinher level of safety performance for both evolutionary and parsive LWR standard designs in the area of severe accidents and in other selected areas. As a result, the NRC staff proposed new requirements in various Commission papers, such as SECY-90-016 and SECY-93-087, to be used in the design certification review and treated as applicable regulations in the design certification rulemaking (refer to discussion on Topic #8). The bases for these requirements are set forth in SECY-90-016 and SECY-93-087. 1he Commission approved the use of these proposed regulations for purposes of the design certification review in the respective SRMs. These proposed regulations deviated from or were not embodied in current regulations applicable to the standard design. The NRC staff then selected proposed regulations that were applicable to the design under rtview and reviewed the design pursuant to these applicable regulations, The FSER identifies the applicable regulations thdt were used knd describes how these regulations were met by the design-related information in the SSAR.

The Commission approved the evaluation of the design pursuant to the applicable regulations in its approval to publish the FSER.

37

, . _ _ , . , 7_. . , _ _ , , _.-._.y,o _ ,.. - _ . , , . _ ., . . , , _ _ _ . , ,

These proposed applicable regulations are identified in Section 5(c) of this proposed rule to achieve codification through the design certification l rulemaking. The proposed applicable regulations in Section 5(c) are substantively the same as those in the FSER but have been edited for clarity. I These codified requirements, which supplement the ret'J1ations in Section 5(b),

will become part of the Comission's regulations that were " applicable and in effect at the time the certification was issued,' if the Comission adopts them in the final design certification rule. The Comission requests comments on whether each specific applicable regulation is justified (refer to Section IV).

The codification of these additional requirements, in reference to 10 CFR 92.48, is necessary for two reasons. First, it serves as a basis for obtaining public comment on the adoption of the proposed requirements as applicable regulations. Second, it provides confirmation that the requirements are being adopted by the Comission as applicable regulations under i 52.54 for tive design certification being approved. In the absence of this codification, a design certification applicant could argue that the Comission cannot lawfully condition approval of tne design certification on compliance with the requirements used during its review of the design. This is because the proposed requirements, without further Comission action, could be argued as not being ' applicable standards and requirements of the ...

Commission's regulations

  • under i 52.54. Also, without codification of the applicable regulations, the NRC could not perform its reviews in accordance with il 52.59 and 52.63. By codifying these requirements, the NRC intends that for renewal of a certified design under i 52.59, these requirements are 38

part of the applicable regulations in effect at the time that the design

, certification was first issued.

l The Commission may, pursuant to i 53.63(a)(1) and (3), impose a L modificatten of Tier 1 information or issue a plant-specific order, ,

respectively, to ensure that the certified design or the plant complies with the applicable regulations of the design certification rult ao rationale is  !

) that the Commission could not, without re-reviewing the merits of each  :

position, impose a change to Tier 1 information or issue a plant-specific l

$ order merely because the modification was necessary for comaliance with a l matter involving these requirements. Also, the Cwnission would not have a  ;

complete list of regulations for use in evaluating requested changes from the public, applicants, or licensees, thereby degrading the predictability of the licensing process.

I By identifying the regulations that are applicable to each design, 'the l Commission has improved the stability ard predictability of the licensing

, proces,s. By approving the design information that describes how these j

. regulations were met, the Commission has minimized the potential for a 4

differing interpretation of the regulations. Finally, the NRC reiected NEl's

-proposed alternative to applicable regulations in a meeting on April 25, 1994, and in a letter dated July 25, 1994. NEI's proposal to use design information as a surrogate for design-specific (ap,nicable) regulations is not workable ,

for proposed changes because the design information only represents one way of implementing a regulation. The NRC would need the regulation for the design feature'in order to evaluate a proposed change-to the design information.

39

.- . . - . _.. - . - - . - . - - . - . - .- - _ . - _ . - .. .. L - -. . - . - - -

F. Issue resolution for the design certification The purpose of Section 6 of the proposed rule entitled, ' Issue resolution for the design certification," is to iderttify the issues that are considered resolved, if the Commission adopts a final design certification rule and therefore, these issues receive issue preclusion within the scope and a tent of 10 CFR 52.63(a)(4). Specifically, all nuclear safety issues arising Jens the Atomic Energy Act that are associated with the information in tL. NRC staff's FSER or the applicant's DCD are resolved within the meanirig of 6 52.63(a)(4). All issues arising under the National Environmental Policy Act of 1969 associated with the information in the NRC staff's environmental assessment or the severe accident design alternatives in the applicant's Technical Support Document are also resolved within the scope and intent of 5 52.63(a)(4). The issues that are associated with information that is not included in the DCD, such as proprietary information, do not have issue

{

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

G. Duration of the design certification L

The purpose of Section 7 of ti.e proposed rule entitled, " Duration of the design certification," i; in part to specify the time period during which the

standard design certificatir' Ny 'e referenced by an applicant for a construction permit or COL, pun ant to 10 CFR 52.55. This section of the rule also
tates that the design certification remains valid for an applicant or licensee that refer 3nces the design certification until their application is withdrawn or their license expires. Therefore, if an application l

L 40 l

references this_ design certification during the 15-year period, then the

&49n certification rule continues in effect until the application is

<  !. drawn or the license issued on that application expires. Also, the design certification continues in effect for the referencing license if the license it renewed. The Connicsion intends for the proposed rule to remain valid for the life of the plant that references the design certification t*) achfeve the benefits of standardization and licensing stability. This mechc tha'.

rulemaking changes to or plant-specific departures from informati)n in the DCD must be made pursuant to the change process in Section 8 of this proposed rule for the life of the plant.

H. Change Process The purpose of Section 8 of this proposed rule entitled, " Change process," is to set forth the process for requesting rulemaking changes to or plant specific departures from information in the DCD. The Consission has developed a more restrictive change process than for plants that were licensed pursuant to 10 CFR Part 50, in order to achieve a more stable licensing process for eplicants and licensees that reference a design certification rule. Im h>.,ge process in Section 8 is substantively the same as the process proposed in the ANPR.' As a result, Section 8(a) provides the process for changing Tier 1 informaticn and Section 8(b) provides the process

  • This change process has been reorganized for clarity and conformance to the two-tiered rule structure, and to distinguish between generic changes to Tier 1 and 2 information, which are accomplished via rulemaking, and plant-specific departures from Tier 1 and 2 information which may be accomplished by the process defined in Section 8 of this proposed rule. For brevity, this SOC refers to both aspects as constituting the " change process" for this design certification rule.

41 i

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O for changing Tier 2 information. The change process for Tier 1 information .

i uses the change process developed by=the Commission:in the Part 52 rulemaking l for- certified: design-related information. Therefore, the provisions in -

Section 8(a) of the proposed rule simply refer to the appropriate sections in- z

.10 CFR-52.63. - A description of the Tier 1 information that is controlled by Section-8(a)isprovidedintheakvediscussiononcontentt of the design certification (!!!.D).

As discussed in Topic #2, the NRC developed a change process for Tier 2  ;

that- has the same elements as the Tier I change process. Specifically, the Tier 2 change process in Section 8(b) has provisions for generic changes, plant-specific orders, and exemptions similar to those i.,10 CFR 52.63, but some tf the standards for plant-specific orders and exemptions are different.

The standards that must be met in order to Austify a generic change to either Tier 1 or 2 information are the same. When NEI proposed a two-tiered

- structure for design certification rules in its letter of August 31, 1990, it r also stated that NRC sackfits involving matters described in the first tier would be governed by the provisions of i 52.63, whereas i 50.109 would govern backfitting as respects the second tier." As a result, the NRC staff used the I backfit standards in i 50.109 for generic changes to Tier-2 in its proposed design certification rule in SECY-92-287. Subsequently, in a letter dated-

0ctober 5, 1992, NEI changed its position and agreed with the Commission that I

the standard for generic changes to Tier 2 should be the same as the Tier 1 standard. This issue is discussed further in SECY-92-287A, dated March 26, L 1993. Therefore, Section 8 of this proposed rule uses the same standards for

_ generic changes to both Tier 1 and.2 information.

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Although the process in Section 8 for plant-specific orders and exemptions is the same for Tier 1 and 2 information, the standards are different. In order to preserve the benefits of standardization, which is one of the important goals of design certification, the Comission proposes in Section 8(a)(3) that plant-specific orders or exemptions from Tier 1 information must consider whether the special circumstances which i 50.12(a)(2) required to be present outweigh any decrease in safety that may result from the reduction in standardization, as required in 10 CFR-52.63(a)(3). The Comission is not proposing to adopt this additional consideration for plant-specific orders or exemptions from Tier 2 information, in order to achieve additional flexibility. The Comission believes this is acceptable because the Tier 2 information is not as safety significant as the Tier 1 information. Therefore, Sections 8(b)(3) and (4) of the proposed rule do not require the additional consideration of the reduction in standardization caused by proposed departures from Tier 2 information.

A generic change to either Tier 1 or 2 information in the DCD is accomplished by rulemaking. Any person seeking to make a generic change to the DCD, including the applicant for this design certification, must submit a petition pursuant to 10 CFR 2.802. This petition must describe how the proposed change meets the standards in 10 CFR 52.63(a)(1) for justifying a generic change to the DCD. Any generic changes to the DCD resulting from the rulemaking will be noticed in the Federal Register. The NRC will update the master DCD in its central files and the copies in the NRC Library and public document room (refer to the discussion in Section III.D). Under Sections 8(a)(2) and (b)(2), generic changes to Tier 1 and Tier 2, respectively, will be applicable to all plants referencing the design certification. However, if

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the Commission determines that a generic change is not technically relevant to a particular plant, based en plant-specific changes made pursuant to Section 8, then the generic rulemaking will indicate that the change will not be applicable to that plant. If the proposed change to the DCD also results in a violation of an underlying regulation that is applicable to this design certification, then an exemption to that regulation is also required.

A plant-specific departure from either Tier 1 or 2 information in the DCD does not require rulemaking. Any person requesting a Commission order directing a plant-specific change, including the applicant for this design certification, must submit a petition pur;uant to 10 CFR 2.206. This petition must describe how the proposed change meets the standards in 10 CFR 52.63(a)(3) or Section 8(b)(3) for departures from Tier 1 or 2 information, respectively. By contrast, an applicant or licensee that references this design certification rule may request exemptions from Tier 1 or 2 information pursuant to 10 CFR 52.63(b)(1) or Section 8(b)(4) of this rule, respectively.

The NRC recognized that there may be special circumstan:es pertaining to a particular applicant or licensee that would justify an exemption from the DCD.

The request must describe how the exemption from Tier 1 or 2 meets the standards in 10 CFR 52.63(b)(1) or Section 8(b)(4) of this proposed rule, respectively. The exemption may be contested in a hearing, if the exemption is granted in connection with issuance of a construction permit, operating license, or combined license; it may also be contested in a hearing, if the exemption also requires the issuance of a license amendment. If a plant-specific change or exemption from the DCD also results in a violation of the underlying regulation that is applicable to this design certification, then an exemption to that regulation is also required.

44 l

In addition to the plant-specific changes described above, an applicant or licensee that references this design certification rule may depart from Tier 2 information, without prior NRC approval pursuant to Section 8(b)(5) of this proposed rule. However, the Commission believes that these changes should open the possibility for challenge in a hearing (refer to discussion on Topic #2). The Commission approved the use of this "I 50.59-like" change process in its SRMs on SECY-90-377 and SECY-92-287A. The NRC is interested in the public's view on how these-changes could be challenged in a hearing (refer to Section IV).

As in 10 CFR 50.59, an applicant or licensee cannot make changes that involve an unreviewed safety question (USQ) or technical specifications, without prior NRC approval. Also, for changes pursuant.to Section 8(b)(5), an applicant or licensee cannot make changes to Tier 1 or Tier 2* information without prior NRC approval. If the proposed change does not involve these factors, then the NRC will allow changes to previously approved information in i Tier 2 without prior NRC approval. However, if the change involves an issue that the Comission has not previously approved, then NRC approval is 1

I required. The process for evaluating proposed tests or experiments not described in Tier 2 will be developed for an operating or combined license j l

that references this design certification (refer to Section IV).

l The restriction on changing Tier 1 information is included in the process in Section 8(b)(5) because this information can-only be changed pursuant to Section 8(a) of the proposed rule. Whereas, the restriction on changing Tier 2* information resulted from the development of the Tier 1 information in the DCD. A description of the Tier 1 information is provided  ;

in the discussion in Section III.D on contents of the design certification.  !

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During the development of the' Tier I information, the applicant for design certification requested that the. amount of information-in Tier 1 be minimized to provide additional flexibility for the applicant or licensee that references this design certification'. Also, many-codes, standards, and design processes,:which were not specified in Tier 1, that are acceptable for meeting ITAAC were specified in Tier 2. The result of these actions is that certain relatively significant infomation only exists in Tier 2 and the Commission does not want this significant information changed without prior NRC approval.

The NRC specified this information in its FSER and the design certification applicant has identified this information in its DCD. This information has come to be known as Tier 2* information and it has compensated for industry's desire to minimize the' amount of infomation in Tier 1.

In the ANPR, the NRC referred to the Tier 2* information as pre-identified unreviewed safety questions (USQs) because there was already an established procedure in 10 CFR 50.59 for FSAR changes that constitute USQs, which require NRC approval. NEl stated in its comments on the ANPR that it was not necessary to create an artificial set of USQs in order to acccmplish the NRC's objective of requiring prior approval. Therefore, the proposed rule was changed from the ANPR to-simply state that the Tier 2* information cannot be changed without prior NRC approval. Also, NEl requested in its comments that the Tier 2*-inft-reation not be identified in the design certification rule, as was proposed in the ANPR, and that an expiration date ne considered for the restriction in the change process for Tier 2* information. NRC agrees that Tier 2* infomatie, can be identified in the DCD and Section 8(b)(5) of the proposed rule was changed accordingly. The NRC also reevaluated the

duration of the change restriction for Tier 2* information and determined that 46

s.

Agag of the Tier 2* information can expire when the plant first achieves 100%

power while other Tier 2* infomation must remain in effect throughout the life of the plant that references the DCR. The DCD sets forth an expiration date for some of the Tier 2* infomation.

As part of this rulemaking, the NRC is seeking public comments on the appropriate regulatory process to use for review of proposed changes to Tier 2* information. Currently, pursuant to 10 CFR 50.59, the NRC approves changes to FSAR infomation that constitute a USQ or involve technical specifications through the issuance of license amendmente. However, if an applicant or licensee requests NRC approval for a proposed change to Tier 2* informatinn, should the NRC review process be similar to that for a USQ7 While it is cle1r that these proposed changes would all involve significant design-related information and that prior review of proposed departures from Tier 2 information is necessary, the NRC has not determined if it is always appropriate to process the approved changes as either an amendment to the license application or an amendment to the license, with the requisite hearing rights. Therefore, the NRC requests the public's view on the preferred regulatory process for these changes (refer to Section IV).

An applicant or licensee that plans to depart from Tier 2 information, pursuant to Section 8(b)(5), must prepare a safety evaluation which provides the bases for the detemination that the proposed change does not involve an unreviewed safety question, a change to Tier 1 or Tier 2* information, or a change to the technical specifications. In order to achieve the Commission's goals for design certification, the evaluation needs to consider all of the matters that were resolved in the DCD, including the generic issues discussed in Chapter 20 of the FSER. The benefits of the early resolution of safety 47

kssues would be lost if changes were made to the DCD that violated these resolutions without NRC approval. The evaluation of the resolved issues needs to consider the proposed change over the full range of power operation from startup to shutdown, including issues resolved under the heading of shutdown risk, as it relates to anticipated operational occurrences, transients, and design basis accidents. The evaluation should consider the ;ibles in Sections 14.3 and 19.15 of the DCD to ensure that the proposed change . toes 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. CE provided more detailed cross-references to Tier I for these analyses in a letter dated March 31, 1994, and ABB-CE provided more detailed cross-references in a letter dated June 10, 1994. The NRC does not endorse NSAC-125, ' Guidelines for 10 CFR 50.59 Safety Evaluations," for performing the safety evaluations required by Section 8(b)(5) of the proposed rule. However, the NRC will work with industry, if it is desired, to develop an appropriate guidance document for implementing Section 8 after the final rule is issued.

During the review of its DCD, GE requested that the determination of whether a proposed departure from Tier 2 information that involves severe accident issues constitutes a USQ use criteria that are different from the criteria for USQ determinations proposed in the ANPR [10 CFR 50.59(a)(2)). GE argued that not all increases in the probability or consequences of severe accidents are significant from a safety standpoint. Minor increases in the probability of some accident scenarios will not affect the overall core damage frequency or the conclusions of the severe accident evaluations. Therefore, 48 1

I I

- = . - - .. -- ..

GE proposed that changes to Tier 2 infomation that result in insignificant increases in the probability or consequences of severe accidents not constitute a USQ.

The NRC believes that it is important to preserve and maintain the resolution of severe accident issues just like all other safety issues that were resolved during the design certification review (refer to SRM on SECY 377). However, because of the increased uncertainty in severe accident issue resolutions, the NRC has proposed, in Section 8(b)(5), separate criteria for determining whether a departure from information associated with severe accident issues constitutes a USQ. The new criteria in Section 6(b)(5)(iii) will only apply to Tier 2 information that is associated with the severe accident issues discussed in the section of the DCD identified in the rule.

The criteria for USQ deteminations in Section 8(b)(5)(ii), which are the same as those proposed in the ANPR, will apply to other Tier 2 information. If the proposed departure from Tier 2 information involves the resolution of other safety issues in addition to the severe accident issues, then the USQ determination should be based upon the criteria in Section 8(b)(5)(ii). The NRC is interested in the public's view on whether the Tier 2 information involving resolutions of severe accident issues should be treated differently for USQ determinations than all other safety issues? If so, are the proposed criteria in Section 8(b)(5)(111) sufficient to determine if a proposed departure from information associated with severe accident issues constitutes a USQ7 (Refer to Section IV)

The NRC is also proposing two additional provisions to the change process that were not in the ANPR. The first is Section 8(b)(5)(iv), which provides that changes made pursuant to Section 8(b)(5) do not also require an i l

49 l

exemption from the design certification rule. Because the Tier 2 information is incorporated by reference into the design certification, a departure from Tier 2 pursuant to Section 8(b)(5) would also require an exemption from the design certification rule absent this proposed provision. The second provision is Section 8(c), which makes it clear that proposed changes to requirements in this design certification rule that are neither Tier 1 nor Tier 2 must be done by exemption pursuant to 10 CFR 50.12. Such requirements include the recordkeeping and reporting requirements in Section 9 of this proposed rule.

I. Records and Reports The purpose of Section 9 of this proposed rule entitled, " Records and Reports," is to set forth the requirements for maintaining records of DCD changes and submitting reports to the NRC. This section is similar to the requirements for records and reports in 10 CFR Part 50 and 5 52.63(b)(2), with the following differences. Section 9(a)(1) requires an applicant for design certification to maintain an up-to-date copy of the DCD that includes all generic changes to Tier 1 and 2 information that are made by rulemaking. This will ensure that the design certification applicant provides up-to-date versions of the DCD to prospective applicants that want to reference this design certification or to other interested parties who want copies of the DCD. Section 9(a)(2) requires an applicant or licensee that references this design certification to maintain in up-to-date plant-specific ve.sion of the DCD that includes both generic changes to the DCD, as well as plant-specific departures from the DCD. This ensures that the plant records which include an 50

accurate DCD 'eflecting information specific to the plant as well as changes to the DCD.

The proposed rule also establishes reporting requirements in Section 9(b) for' applicants or licensees. that raference this design. certification rule.- The requirements in Section 9(b) are similar to the reporting-requirements in 10 CFR Part 50, except that they include reporting of changes to or departures from the plant-specific DCD. In addition, the reporting

! requirements in Section 9(b) vary according to whether the changes are made as 4

part of an application, during plant construction, or during operation. Also, the reporting frequency of suinnary reports of departures from and periodic updates to the DCD increases during plant construction. If an applicant that references this; design certification rule decides to adopt departures from the DCD that were developed, but not approved pursuant to Section 8 of this proposed rule, before its application (i.e., first of a kind engineering),

then the proposed departures from the DCD must be submitted with the initial application for a construction permit or combir<d license.

For currently operating plants, a licensee is required to maintain records of the basis for any design change made to the plant pursuant to 10 CFR 50.59. Further, a licensee is required to previde a sumary of these e changes to the NRC annually or along with updates to the final safety analysis report pursuant to 10 CFR 50.71. The proposed rule allows departures from the DCD during the periods of application, construction, and operation of the plant. Therefore, the proposed rule requires timely submittal of sumary reports of departures froa, as well as updates to, the D:D during each of these intervals, consistent with the Commission's guidanca on reporting frequency.in its SRM on SECY-90-377.

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NEI proposed reporting of design changes at-a 6-month interval, in its comments on the ANPR, to " avoid unnecessarily diverting owner / operator resources to meet excessive reporting requirements." The NRC modified the provisions in the proposed rule to relax the reporting requirements before issuance of a construction permit or combir.ed license. During this interval, summary reports of changes and updates to the DCD should be submitted to the NRC as part of the amendments to the construction permit or combined license application. However, the NRC does not agree with the NEI proposal for semi-annual reporting of design changes during plant construction because it does not provide for sufficiently timely notification of design changes.

Therefore, the Commission retained the requirement for quarterly reporting of changes in the proposed rule during this interval. Also, the NRC relaxed the provisions in Section 9(b) so that during operation of a plant, the reporting requirements are the same as for currently operating plants.

The Commission believes that quarterly reporting of design changes during the period of construction are necessary to closely monitor the status and progress of the construction of the plant. As required by 10 CFP. 52.99, J

the NRC must-find that the ITAAC have been successfully met. The ITAAC verify that the as-built facility conforms with the approved design and emphasize design reconciliation and design verification of the as-built plant. To make its finding, the NRC must tailor its inspection program to monitor plant construction and adjust its program to accommodate changes. Quarterly reporting of design changes will facilitate these adjustments in a timely manner and aids in a common understanding of the plant as the changes are being made. This is particulkrly important in times where the number of design changes could be significant, such as during the procurement of 52

components and equipment,- detailed. design of the: plant at the start of construction, and during pre-operational testing.-

Section 9(c) of the proposed rule requires that records are kept for the lifetime of a facility, as in 10 CFR Part 50 and i 52.63(b)(2).

J. Applicability of a DCR in 10 CFR Part 50 licensing proceedings.

Several provisions in 10 CFR Part 52, Subpart B suggest that design certification rules (DCRs) may be referenced not only in combined license proceedings ander 10 CFR Part 52, Subpart C but also in licensing proceedings under 10 CFR Part 50. Section 52.63(c) states:

The Connission will require, prior to granting a construction permit, combined license, or operating license which references a standard design certification, that information normally contained in certain procurement specifications and construction and installation specifications be completed and available for audit if such information is necessary for the Commission to make its safety determination, including the determination that the-application is consistent with the certified design. (Emphasis supplied.)

Itat Als.g il 52.41, 52.55(b), 52.55(c), 52.63(a)(4), 52.63(b)(1).

However, these provisions of 10 CFR Part 52, Subpart B are inconsistent in '

l identifying the type of Part 50 proceeding in' which design certification rules may be referenced. For example, although i 52.63(c) (quoted above) and

o 53 1

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4 i 52.55(c) explicitly provide for referencing of design certification rules in 10 CFR Part 50 construction pensit proceedings, il 52.55(b), 52.63(a)(4) and 52.63(b)(1) refer only to operating ifcense proceedings. Section 52.63(a)(4) is illustrative:

Except as provided for in 10 CFR 2.758, in making the findings required for issuance of a combined license or operating license, or for any hearing under i 52.103, the Commission shall trett as resolved those matters resolved in connection with the issuance or renewal of a design certification. (Emphasis supplied.)

Therefore, some might question whether the Commission intended construction permits applicants under 10 CFR Part 50 to have the option of referencing design certification rules. However, the Commission has not identified any regulatory or policy reasons for precluding a construction permit applicant from referencing a design certification rule while allowing an operating license applicant to do so. Thus, the Commission believes that 10 CFR Part 52 provides the discretion to authorize a construction permit applicant under 10 CFR Part 50 to reference a design certification rule.

Assuming that the Commission has such discretion, there are a number of issues that present themselves. Should the Commission exercise its discretion to allow construction permit applicants to reference this design certification rule? Should the Commission require that if a design certification rule is to be relied upon in 10 CFR Part 50 licensing proceedings, it must be referenced in both the construction permit and operating license applications? Would it make 54

sense to allow an operating license applicant to reference a design certification if the underlying construction permit did not reference the design certification? The Commission recognizes that consideration of these issues depends in part upon the legal significance of a design certification in the 10 CFR Part 50 licensing proceeding, as well as its significance for the permittee or licensee once the construction permit or operating license is granted. In particular,10 CFR Part 52, Subpart B does not say what the legal effect is (if any) of ITAAC in a Part 50 operating license proceeding in which the underlying construction permit references a design certification.

In view of the status of ITAAC as Tier 1 information, how would a construction permit applicant referencing a design certification rule avoid referencing the ITAAC7 What would be the consequences for the construction permit applicant of referencing ITAAC7 If the underlying construction permit referenced ITAAc, then what (if any) would be the scope and nature of " issue preclusion" at the operating license stage, in terms of staff / Commission review and approval of the operating license application, as well as issues which are precluded from consideration under 10 CFR 2.7S87 The Commission seeks the public's views on the referencing of design certification rules in 10 CFR Part 50 applications (refer to Section IV).

IV. SPECIFIC REQUESTS FOR COMMENTS In addition to the general invitation to submit comments on the proposed rule, the DCD, and the environmental assessment, the NRC also invites specific comments on the following questions:

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1. Should. the requirements of-10 CFR 52- 63(c) be added to' a new- .

10CFR52.79(e)?:(RefertodiscussioninIII.A.). _

2. Are there other words'or phrases that should be defined in Section 2 L of the proposed rule? (Refer to discussion in-!!I.B.).

I

3. What change-process should apply to design-related information-developed by a COL applicant or holder that references _ this-design certification rule? (Refer to discussion in III.D.)- .;
4. Are each of the applicable regulations set forth in Section 5(c) of 1 the proposed rule justified? (Refer to discussion in III.E.)
5. Section 8(b)(5)(1) 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)(1) states that a change

\; made pursuant to that paragraph will no longer be consiMd as a matter L resolved in connection with the issuance or renewal of a OA q certification within the meaning of 10 CFR 52.63(a)(4), should this mean that the determination may be challenged as not demonstrating that the change may be made without prior NRC approval'or that the change itself may be challenged as not ,

! complying with the Commission's requirements?- (Refer to discussion in III.H.)

l- 6. How-should the determinaticns made by an applicant or licensee that ,

changes may. be made under Saction 8(b)(5)(1).without prior NRC approval be made available to the public in' order for those determinations to be challenged or-for the changes themselves to be challenged? .(Refer to discussion in III.H.)

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. _2.__. . _ _ . _ _ . . _ - .. . _ _ _ _ , _

7. What is the preferred regulatory process (including opportunities for public participation) for NRC review of proposed changes to Tier 2* information and the connenter's basis for reconnending a particular process? (Refer to discussion in !!!.H.)
8. Should determinations of whether proposed changes to severe accident issues constitute an unreviewed safety question use different criteria than for other safety issues resolved in the design certification revicw and, if so, what should those criteria be? (Refer to discussion in III.H.)

9(a)(1) Should construction permit applicants under 10 CFR Part 50 be allowed to reference design certification rules to satisfy the relevant requirements of 10 CFR Part 50? (Refer to discussion in III.J.)

(2) What, if any, issue preclusion exists in a subsequent operating license stago and NRC enforcement, after the Commission authorizes a construction permit applicant to reference a design certification rule?

(3) Should construction pennit applicants referencing a design certification rule be either permitted or required to reference the ITAAC7 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?

57

9(b)(1) Should operating license applicants under 10 CFR Part 50 be allowed to reference design certification rules to satisfy the relevar.t requirements of 10 CFR Part 507 (Refer to discussion in III.J.) ,

(2) What should be the legal consequences, from the stai.dpoints of issue resolution in the operating license proceeding, NRC enforcement, ano li:ensee operation if a design certification rule is referenced by an applicant for an operating license under 10 CFR Part 507 (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 (14 ., without foreclosing alternatives for future resolution).

V. COMMENTS AND HEARINGS IN THE DESIGN CERTIFICATION RULEMAKING A. Opportunity to Submit Written and Electronic Comments Any person may submit written connents on the proposed design certification rule to the Commission for its consideration.3 Connenters have 120 days from the publication of this notice to file written comaxnts on the proposed design certification rule. Commenters needing access to proprietary information in order to provide written comments must follow the procedures and filing deadlines (including the date for filing w*itten ccmments) which are set forth in Section V.E. below.

Commenters are encouraged to submit, in addition to the original oaper copy, a copy of tha comment letter in c.iectronic format on a DOS-forintted (IBM compatible) 3.5 cr 5.25 inch computer diskette. Text files should be provided

  1. A n opportunity for public comment is required by Section 553 of the Administrative Procedures Act and 10 CFR 52.51(b).

58 ,

in Wordperfect format or unformatted ASCII code. The format and version should be identified on the diskette's external label, Coments may also be submitted electronically, in either ASCII text or Wordperfect format (version 5.1 or later), by calling the NRC Electronic Bulletin Board on FedWorld. The bulletin board may be accessed using a personal computer, a moda, and one of the comonly available comunications software packages, or directly via Internet.

If using a personal computer and modem, the NRC subsystem on FedWorld can be accessed directly by dialing the toll free number (1-800-303-9672).

Communication software parameters should be set as follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1). Using ANSI terminal emulation, the NRC rules subsystem can then be accessed by selecting the " Rules option from the "NRC Main Menu." For further information about options available for NRC at FedWorld consult the

  • Help /Information Center" from the "NRC Main Menu." Users will find the "FedWorld Online User's Guides" particularly helpful. Many NRC subsystems and databases also have a " Help /Information Center" option that is tailored to the particular subsystem.

The NRC sebsystem en FedWorld can also be accessed by a direct dial phone number for the main FedWorld BBS: 703-321-3339; Telnet via Internet:

fedworld. gov (192.239.92.3); File Transfer Protocol (FTP) via Internet:

ftp.fedworld. gov (192.239.92.205); and World Wide Web using:

http://www.fedworld. gov (this is the Uniform Resource Locator (URL)).

If using a method other than the toll free number to contact FedWorld, then the NRC subsystem will be accessed from the main FedWorld menu by selecting i the "U.S. Nuclear Regulatory Comission" option from FedWorld's

" Subsystems / Databases" menu or by entering the comand "/go nrc" at a FedWorld comand line. If NRC access is obtained through FedWorld's i

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' Subsystems / Databases' menu, then return to FedWorld is accomplished by selecting the ' Return to FedWorld' option from the 'NRC Main Menu." However, if NRC access at FedWorld is accemplished by using NRC's toll-free number, access to all NRC systems is available, but there will be no access to the main-FedWorld system.- For nors information on NRC bulletin boards call Mr. Arthur Davis,- Systems Integration and Development Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-5780; e-mail AXD39nrc. gov.

Public Meeting The NRC staff plant to conduct a public meeting on this proposed rule on May-11, 1995, at the NRC ~.uditorium in Two White Flint North. Further details s

on the. meeting are provided in a document published in this issue of the Federal Register. The purpose of the public meeting will be to discuss this proposed rule and respond to questions on the meaning and intent of any provisions of this propoced rule. It is hoped that this meeting will be helpful to persons who intend to submit written comments on the proposed rule. An official trars- ipt of the proceedings of the public meeting will be prepared.

B. Opportunity to Request Hearing Any person may request an informal hearing on one or more specific matters with espect-to-the proposed design certification rule.' An-informal hearing-provides the admitted party with an opportunity to provide written and oral presentationt on those matters to an Atomic Safety and Licensing Board, and to request that the licensing board question the applicant on those matters. The

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

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conduct of an infomal hearing is discussed in more detail in Section C. below.

under certain circumstances, a party in an informal hearing may requast that the

. Commission hold a formal hearing on specific and substantial factual disputes l

r.ecessary to resolution of the matters for which the party was granted an i informal hearing (itt Section C.11 below).

A person may request an informal hearing even though that person has not submitted separate written comments on the design certification rule (L.g., is not a commenter). Requests for an informal hearing must be received by the Comission no later than 120 days from the publication of this notice, and a copy of the request must be sent via overnight mail to the design certification applicant at the fo119 wing address: Mr. Charles B. Brinkman, Director, Nuclear Systems Licensing. ABB-Combustion Engineering, Inc., P.O. Box 500, 1000 Prospect Hill Road, Windsor, Cl 06095-0500. The information which a person requesting a hearing must provide in the hearing request, as well as the procedures and standards to be used by the Comission in its determination of the request, are discussed in Sections C.1 through C.4 below.

A person who needs to review proprietary information submitted by the design certification applicant in order to preparo a request for an informal hearing must follow the procedures and filing schedule set forth in Section V.E.

below.

The Comission is also providing an opportunity for interested State, county, and city / municipal and other local Governments, as well as Native American tribal governments to participate as " interested gcvernments" in any informal hearings which the Comission authorizes, similar to their participation as " interested governments" in Subpart G hearings under 10 CFR 2.715. State, county, city / municipal, local, and tribal Governments 61

< wishing to participate as an " interested government" in any design certification rulemaking hearicgs which may be held must file their request to participate no later than 120 days from the publication of this notice. l i

C. Hearing Process

1. Filings and Computation of Timos All notices, papers, or other filings discussed in this section must be filed by express mail.' The time periods specified in this section have been established based upon such a filing. The express mail filing requirement shall be con::idered in establishing other filing deadlines.

In computing any period of time, the day of the act, Event, or default after which the designated period of time begins to run is not included. lhe last day of the period so computed is included, unless it is a Saturday, Sunday, or legal holiday at the place where the action or event is to occur, in which case the period runs until the next day which is neither a Saturday, Sunday, nor holiday.

2. Content of Hearing Request The Commission will grant a request for an informal hearing only if the hearing request satisfies each of the following two requirements. First, the hearing request must include the written presentations which the requestor 5

Filings discussed in this section may also be served upon the Commission in electronic form in lieu of express mail. However, parties must serve copies of their filings on other parties by express mail, unless the receiving party agrees to filing in electronic form. ' These filings must be transmitted no later than the last day of the time period specified for filing and must be in accordance with the requirements specified in the Summary.

62

wishes to be incl.,ded in the record of the hearing. .The written presentations must:

(1) Identify the specific portion of the proposed design certification rule or supporting bases wh(ch are challenged, (ii) Describe the reasons why.the proposed rule or supporting bases are incorrect or insufficient, and (iii) Identify the references or sources upon which the person requesting the hearing relies.

If the requestor has submitted written comments in the public comment period addressing these three factors for the specific issue for which the requestor seeks a hearing, it will be sufficient for the requestor to identify the portions of the written coments which the requestor intends to submit as a i

written presentation. Also, the hearing request must demonstrate that the requestor (or other persons identified in the hearing request who will represent, assist, or speak on behalf of the requestor at the hearing) has appropriate knowledge and qualifications to enable the requestor to contribute significantly to the development of the hearing record on the specific matters at issue. The Commission does not intend that the requestor meet a judicial

" expert witness" standard in order to meet the second criterion. Nonetheless, given the substantial commitment of time and resources associated with any hearing, the Commission believes it to be a reasonable prerequisite that the hearing requestor demonstrate that he/she (or his/her assistant) has:

(i) Substantial familiarity with the publicly available docketed information relevant to the issue for which a hearing is requested; (ii) The requisite technical capability to understand the factual matters and develop a record on the issue for which a hearing is requested, and 63 l

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(iii) An understanding of the NRC's hearing procedures in 10 CFR Part 2.'

3. Request to Hold Hearing Dutside of Washington, DC Any hearing (s) which the Commission may authorize ordinarily will be-conducted in the Washington, DC. metropolitan area. However, the Commission at its discretion may schedule hearings outside the Washington, DC. metropolitan area in respor.se to requests submitted by a person requesting a hearing that all or part of the hearing be held elsewhere. These requests must be submitted in conjunction with the request for hearing, and must specifically explain the special circumstances for holding a hearing outside the Washington, DC.

metropolitan area.

4. Responses to Hearing Request The applicant may file a response to any hearing request within 15 days of the date of the hearing request. The NRC staff will not provide a response to t

the hearing request unless requested to do so by the Commission but may assist i

-the Commission in its ruling on the request.

5. Commissinn Determination of Hearing Request The Commission intends to rule on a hearing request within 20 days of the close of the period for requesting a hearing. The Commission's determination will be based upon the materials accompanying the hearing request and the applicant's response (and the NRC staff's response, if requested by the Commission). The hearing' request shall be granted if: l

' Requestors' will satisfy this requirement by stating that they possess and q have read a copy-of 10 CFR Part 2, Subparts A, G, and L.

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(i) The request is accompanied by a written presentation containing the information required by Section C.2. above; and (ii) the .equestor has the appropriate knowledge und qualifications to enable the requestor to contribute significantly to the development of the hearing record on the matters sought to be controverted.

The Commission may consult with the NRC staff before its determination of- 3 a hearing request. A written decisten either granting or denying the hearing request will be published by the Commission.

If a hearing request is granted in whole or in part, the Commission's decision will delineate the coritrovarted matter that will be the subject of the hearing and whether any issues and/or parties are to be consolidated (igg .

i Section C.7. below). The Commission's decision granting the hearing will direct the establishment of a licensing board to preside over the informal hearing.

Finally, the Commission's decision will specify:

1 (i) The date by which any requests for discovery must be ffled with the licensing board (normally 20 days after the date of the Commission's decision),

and (11) The date by which any objections to discovery must be filed (igg Section C.9. below).

The Commission's decision will be sent to each admitted party by overnight mail. Separate hearings may be granted for each controverted matter or set of consolidated matters. Thus, if there are three different controverted matters, the Commission may establish three separate hearings. In this fashion, closing of the hearing record on a controverted matter and its referral to the Commission for resolution need not await completion of the hearing on the other controverted matters. Finally, the Commission's decision will rule on any 65 9

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requests:for hearings outside'of.the Washington, DC. metropolitan area (igg Section C.3 above).

6. Authority of the Licensing Board if the Commission authorts.es an informal hearing on=a controverted matter, the licensing board will function as a " limited magistrate" in that hearing with the authorfty.and responsibility for assuring that a sufficient record.is developed on those cr'ntroverted matters which the Commission has determined are appropriate <for consideration in that hearing. The licensing board shall have the following specific responsibilities and authority:  ;

(1) Schedule and expeditiously conduct the informal hearing for each admitted controvsrted matter, consistent with the rights of all the parties,-

(ii) Review al1~ discovery requests against the criteria established by i

the Comission, arid refer all appropriate requests to the Commission with a decision explaining the licensing board's action, (iii) Preside over and resolve any issues regarding the scheduling and conduct of any discovery authorized by the Commission, (iv) Order such further consolidation of parties and issues as the licensing board determines is necessary or desirable, (v) Orally examine. persons making oral presentations in the informal hearing,_baced in part upon the licensing board's review of the parties'

proposed oral questions te be asked of persons making oral presentations, (vi) Request that the NRC staff:

(A) Answer licensing board questions about the SER or the proposed rule, t

(B) Provide additional information or documentation with respect to the l .

-design certification, and 1

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(C) Fravide other_ assistance as the licensing. board may request.

Licensing board requests for NRC staff assistance should be framed such that the NRC staff does not assume a role as an adversary party in the informal hearing

( m Section C.8 below),

(vii) Review all requests for additional hearing procedures and refer all appropriate requests to the Comission with a decision explaining the licensing board's action, (viii) Certify the hearing record to the Commission, based upon the licensing board's determination that the hearing record contains sufficient information for the Comission to make a reasoned determination on the controverted matter; and (1x) Include with its certification any concerns identified by the licensing board in the course of the hearing which, although neither raised by the parties nor neces;ary to resolution of the controverted hearing matters, are 4

significant enough in the licensing board's view to warrant attention by the Commission.

Licensing board determinations with respect to referral of requests to the Comission, as well as licensing board determinations of parties' motions, are not appealable to the Comission as an interlocutory matter. Instead, any disagreements with the licensing board's determinations and a specific discussion of how the hearing record is deficient with respect to the contested issue must bc, set forth in the parties' proposed findings of fact which are subm!tted directly to the Cemission (m Section C.13 below).

As suggested by Item (10) above, the licensing board shall not have any "sua sponte" authority analogous to 10 CFR 2.760a. The Comission believes that in the absence of a request for an informal hearing on a matter, the Comission 67

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should resolve issues with respect to the design certification rule in the same manner as other agency-identified rulemaking issues, ytz., through NRC staff consideration of the issue followed by the Comission's review and its final resolution of the matter. However, when it certifies the completed hearing record to the Comission (in Section C.)?. below), the Itcensing board should identify to the Comission any concerns identified during the hearing that are significant enough to warrant Comission consideration but that are unnecessary or irrelevant to the resolution of the controverted hearing matter.

The licensing board shall close the hearing and certify the record to the Comission only af ter it detemines that the record on the contro"nrted matter is sufficiently complete for t'ie Comission to make a reasoned determination with res,,,,ct to that matter. However, th* licensing board shall not have any responsibility or authority to resolve and decide controverted matters in either an informs 1 or a formal hearing. Rather, the Comission retains its traditional authority in rulemaking proceedings to evaluate and resolve all rulemaking issues identified in public coments on a proposed rule. Therefore, the Comission will resolve any controverted matters that are the subject of a hearing in this u ign certification rulenaking.

7. Consolidation of Parties and Issues; hint Hearings on P, elated issues.

If two or more persons seek an informal hearing on the same or similar matters, the Comission may, it, its discretion, grant an informal hevring and consolidate the matters into a single issue (as defined by the Comission). The Comission may also, in its discretion, require that the parties be consolidated analogous to the consolidation pe mitted under 16 CFR 2.715a. If the Comission l 68 l

consolidates two or more issues into a single consolidated issue but does not consolidate parties, each admitted person will be deemed a separate party with an individual right to:

(1) Submit separate written presentatins, (11) Submit separate sets of proposed oral questions to be asked by the licensing board (sit Section C.10 below),

(iii) Make separate oral presentation, and (iv) Submit and separately respond to motions.

If the Commission also requires that parties be consolidated, the consolidated parties must participate jointly, including deciding upon written and oral presentations, submitting a single set of written questions, sut'mitting motions supported by each of the consolidated parties, and responding to motions filed by other parties.

During the 'nformal hearing, the licensing board may decide that further consolidation of issues or parties would simplify the overall conduct of informal hearings or materially reduce the time or rer,urces devoted to the hearings. In these instances, the licensing board may direct such consolidation. The licensing board shall set for?S the issues and/or parties to be consolidated and the reasons for such consolidation in a written order.

8. Status of the Design Certifintion Applicant, the NRC staff, and Requesting Party The design certification applicant shall be a party in the informal hearing, with the right to submit written and oral presentations, propose questions to be asked by the licensing board of oral- presenters, and file and submit appropriate motions.

69 a._, , - - ,- -

1 The NRC staff shall not be a party in the informal hearing but shall be i available in the informal hearing to answer licensing board questions about the FSER or the proposed rule, provide additional information or documentation with respect to the design certification, and provide other assistance that the licensing board may request without the NRC staff assuming the role of a party in the informal hearing.

A party whose hearing requests have been granted with respect to a particular controverted matter shall not participatt with respect to any controverted matter on which the party was not granted a hearing. For example, if Person 1 has been authorized as a party on Issue A and Person 2 has been authorized as a party on issue 8, then Person 1 may participate only in the informal hearing on issue A, and may not participate in the informal hearing on 1ssue B. Conversely, Person 2 may participate only in the informal henring on Issue B, and may not participate in the informal hearing on issue A.

9. Requests for Discovery Any party may request the opportunity to conduct discovery against another party before the oral phase of the informal hearing. The request for discovery must:

(i) Identify the type of discovery permitted under 10 CFR li 2.740, 2.740a, 2.740a(b), 2.741, and 2.742 which the party seeks to use; (ii) Identify the subject matter or nature of the information sought to be obtained by discovery; and (iii) Explain with particularity the relevance of the information sought to the controverted matter which is the subject of the hearing and why this 70

_.-- . . - - - - _ - . - = _ _ _ . - _ . _ -,-. -. . _ - - _ . - - , - _.

t information is indispensable to the presentation of the party's position on the controverted matter.

The request shall be filed with the licensing board, with copies of the request t to be filed with the party against which discovery is sought, and the NRC staff.

The requests must be received no later than the deadline specified by the Comission in its decision granting a party's hearing request (at Secticn C.S.

above). A party against whom discovery is sought may file a response objecting to part or all of the request. Such a response must explain with particularity why the discovery request should not be granted.

The licensing board shall review all discovery requests and refer to the Comission those requests that it believes should be granted within i ays after the date for receiving a party's objections to a discovery request. The licensing board shall issue a written decision explaining its basis for either referring the request to the Comission or declining to refer it. The written decision shall accompany the discovery requests which are referred by the licensing board to the Comission.

The Comission will determice whether to grant any discovery requests forwarded to it based upon the licensing board's decision, together with the request and the design certification applicant's response (and any NRC staff response requested by the licensing board). Discovery will be at the discretion of the Comission. In this regard, the Ccamission notes that there are several docket files in which the NRC staff has placed information and documents received from the design certification applicant for the System 80+ design certification review. The application was docketed on May 1, 1991 and assigned Docket No.52-002. Correspondence rela',ing to the application prior to this date was also addressed to Docket No. STN 50-470 and Project No. 675. This 71

._ ~ . . _. _ . _ . --

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information includes the Design Control Document and the Technical Support 4 Document for Amendments to 10 CFR Part 51 Considering Severe Accidents Under NEPA for Plants c,f the System 80+ Design, Revision 2. Furthermore, the docket flies contain NRC staff comunications and documents, such as written questions and comments provided to the design certification applicant, and summaries of meetings held between the NRC staff and thi design certification applicant. The l

NRC staff's bases for approving the System 80+ design are set forth in the FSER (NUREG-1462), dated August 1994. The Comission also notes that each admitted party has already disclosed a substantial amount of information in its hearing request, relating both to bases for the party's position with respect to the controverted matter as well as information on the qualifications of the party (or its representatives and witnesses in the hearing).

As discussed above, much of the information documenting the NRC staff's review and approval of the design certification application has been routinely placed in the docket file. Furthermore as discussed above in Section C.8., the NRC staff is not a party in an informal hearing. Therefore, the Comission has decided that in an informal hearing, the parties should not be afforded discovery against the NRC 4taff.

10. Conduct of Informal Hearing If the Commission authorizes discovery, the licensing board shall establish a schedule for the conduct and completion of discovery. Normally, the licensing board should not permit more than one round of discovery. The Comission will not entertain any interlocutory appeals from licensin,, board orders resolving any discovery disputes or otherwise complaining of the scheduling of discovery.

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i following the completion of discovery, the licensing board should issue an order setting forth the date of commencoent of the oral phase of each-informal  :

hearing, and the date (no less than 30 days before the commencement of the oral phase of the hearing) by which parties must submit

(1) The identitie; and curriculum vitae of those persons providing oral presentations; (ii) The outlines of the oral presentations; and l (iii) Any questions which a party would like the licensing board to ask. ,

The licensing board may schedule the oral phases of two or more informal hearings to be held during the same session. The licensing board shall publish a notice in the Federal Register announcing the commencement of the oral phase of the informal hearing (s). The notice shall set forth the place and time of the oral hearing session, the subjwet matta @ ', d the informal hearing (s), a brief description of the informal hearing procedures, and a statement indicating that the public may observe the informal hearing. l Based upon the parties' outlines of the oral presentations and proposed questions, the licensing board should determine whether it has specific questions of the NRC staff with respect 'to the staff's review of the design certification application. These' questions should be submitted in writing to the NRC staff no less than 20 days before the commencement of the oral phase of the hearing and must specify the date by which the NRC staff shall provide its written answers to the licensing board. The licensing board shall send copies of the request'by overnight mail to all parties. The NRC staff shall file its written answers with the licensing board and the parties.

During the oral phase of'the hearing, the licensing board shall receive into evidence the written presentations of the parties and permit each party (or 73 9

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y

1 the representatives identified in their hearing request) to make oral presentations addressing the controverted matter. Wormally, the party raising the controverted matter should make their presentations, followed by the l

presentations of the design certification applicant. The licensing board may question the persons making oral presentations, using its own questions as well as those-submitted to the licensing board by the other parties. Based upon the parties' oral presentations and/or responses to licensing board questions, the licensing board may also orally question the NRC staff.

11. Additional Hearing Procedures and formal Hearings i

After the parties have made their oral presentations and the licensing board has concluded its questioning of the presenters (and, as applicable, the l NRC staff), the licensing board should declare that the oral phase of an informal hearing on a controverted matter (or consolidated set of controverted matters) is complete.

No later than 10 days after the licensing board has declared that the oral phase of the informal hearing has been completed, parties may file with the licensing board (with copies to the applicant and the NRC staff) a request that some or all of the procedures described in 10 CFR Part 2, Subpart G (3.J.,

direct and cross-examination by the parties) be utilized. The request shall:

(1) Identify the specific hearing procedures which the party seeks, or l

l state that a formal hearing is requested; (ii) Identify the specific factual issues for which the additional procedures would be utilized l (iii) Explain why resolution of these factual disputes are necessary to the Commission's decision on the controverted issue; i

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(iv) Explain, with specif'.c citations to the hearing record, why the record is insufficient on *w controverted matter; and 1 (v) Identify th' nature of the evidence that would be developed utilizing .

the additional procedures requested. ,.

The design certification applicant may file a response to these requests no later than 7 days after the applicant's receipt of a request for additional ,

procedures. The NRC staff will not provide a response unless specifically requested to do so by the licensing board.

The licensing board will review all requests for additional hearing procedures or a formal hearing and refer those that it believes should be granted to the Comission for its determination. The licensing board shall issue a r ltten decision explaining its determination whether to forward the request to the Comission no later than 7 days after receipt of any applicant ,

response to the request. The decision will provide the basis for either forwarding the request to th'e Commission or declining to forward it. In the absence of any requests for hearing procedures or if the licensing board concludes that none of the requests should be referred to the Comission, the licensing board should declare that the hearing record is closed (itg Section C.12 below).

The Comissun will determine whether to grant any requests for additional procedures or a formal hearing that are forwarded by the licensing board. The Comission's determination shall be based upon the licensing board's decision along with the request and the design certification applicant's response. If the Comission directs that a formal hearing be held on a controverted factual matter, the NRC staff shall be a party in the formal hearing. After either the additional hearing procedures authorized by the Comission are completed or the 75

formal hearing is concluded on the factual dispute, the licensing board should declare the hearing record closed (Att Section C.12 below).

12. Licensing Board's Certification of Hearing Record to the
  • Cosmission.

After the oral phase of a hear'ng is completed and either:

(1) There are no requests for additional hearing procedures or a formal ,

hearing; or.

(ii) The licensing board concludes that none of the requests should be referred to the Commission, then the licensing board should declare that the hearing record is closed.

If the Comission directs that additional hearing procedures should be utilized or a formal hearing be held on specific factual disputes, the licensing board should declare the hearing record closed after completion of the additional  ;

hearing procedures or the formal hearing. Within 30 days of the closing of the hearing record the licensing board should certify the hearing record to the Commission on each controverted matter (or consolidated set of controverted matters).'

The licensing board's certification for each controverted matter (or consolidated set of controverted matters) shall contain:

(1) The hearing record, including a-transcript of the oral phase of the hearing (and any pre-hearing conferences) and copies of all filings by the parties and the licensing board,

'An informal hearing is deemed to be completed when the period for requesting 1 additional procedures or a formal hearing expires and no request is received.

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. i (ii) A list of all documentary evidence admitted by the licensing board, including the written presentations of the parties, (iii) Copies of the documentary evidence admitted by the licensing board, i

(iv) A list of all witnesses who provided oral' testimony, (v) The NRC staff's written answers to licensing board requests, and l (vi) A licensing board state ent that the hearing record contains sufficient information for the Connission to make a reasoned determination on the controverted matter.

Finally, as discussed in Section C.6 above, the licensing board should identify any issues not raised by the parties or otherwise are not relevant to the controverted matters in the hearing, that the licensing board believes are significant enough to warrant attention by the Commission.

13. Parties' Proposed Findings of Fact and Conclusions The applicant must file directly with the Commission proposed findings of fact and conclusions for each controverted hearing ::atter (or consolidated set of controverted matters) within 30 days following the close of the hearing record on that matter in the form of a proposed final rule and statement of considerations with respect to the controverted hearing issues.

Other parties are encouraged, but not required, to file with the Commission proposed findings of fact and conclusions limited to those issues which a party was afforded a hearing by the Commission (lat., a party may not file proposed findings of fact and conclusions on issues which it was not admitted). Any findings that a party wishes the Commission to consider n.ct be received by the Commission no later than 30 days after the licensing board closes the hearing record on that issue. Although parties are not required to 77 J

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. l file proposed findings and conclusions, a party who does not file a finding may  ;

not, upon appeal, claim or otherwise argue that the Comission either  !

misunderstood the party's position, or failed to address a specific piece of evidence or issue.

D. Resolution of Issues for the Final Rulemaking

1. Absence,of Qualifying Hearing Request.

If the Comissior/does not receive any request for hearing within the 120-day period for submitting a reauest, or does not grant any of the requests (see Section B. above), the Comission will determine whether the propos'ed design certification rule meets the applicable standards and requirements of the Atomic Energy Act of 1954, as amended (AEA), the National Environmental Policy Act of 1969, as amended (NEPA), and the Comission's rules and regulations. The Comission's determination will be cased upon the rulemaking record, which includes: the application for design certification, including the SSAR and DCD; the applicant's responses to the NRC staff's requests for additional information; the NRC staff's FSER and any supplements thereto; the report on the application by the ACRS; the applicant's Technical Support Document addressing consideration of severe accident mitigation design alternatives (SAMDAs) for purposes of NEPA; the NRC staff's EA and dreft FONSl; the proposed rule, and the public coments received on the proposed rule. If the Comission makes an affirmative finding, it will issue a standard design certification in the form of a rule by adding a new appendix to 10 CFR Part 52, and publish the design certification rule and a statement of considerations in the Federal Register.

2. Comission Resolution of Issues Where a Hearing is Granted.

78 .

All matters related to the proposed design certification rule, including those matters for which the Commistion authorizes a hearing (itt Sections B. i and C. above), will be resolved by the Commission after the licensing board has l closed the hearing record and certified it to the Commission. The Commission will detemine whether the proposed design certification rule meets the appitcable standards and requirements of the AEA, NEPA, and the Commission's rules and regulations. The Connission's determination will be based upon the rulemaking record as described in Section D.1 above, with the addition of the hearing record for controverted matters. If the Commission makes an affirmative finding, the Connission will issue a final design certification rule as described in Section D.1.

E. Access to Proprietary Information in Rulemaking

1. Access to Proprietary Information for the Preparation of Written Comments or Informal Hearing Requests l Persons who determine that they need to review proprietary information submitted by the design certification applicant to the NRC in order to submit written connents on the proposed certification or to prepare an informal hearing request, may request access to such information from the applicant.

The request shall state with particularity:

(1) The nature of the proprietary information sought,

-(ii) The reason why the nanproprietary information currently available to the public in the NRC's Public Document Room is insufficient either to develop public cour.ents or to prepare for the hearing .

(iii) The relevance of the requested information either to the issue which the commenter wishes to comment on, and 79 l

-- , . - - . . - - - . . - - - - . - . . - . --_ - ~, .-

(iv) A showing that the person requesting the information has the capability to understand and utilize the requested information.

Requests must be filed with the applicant such that they.are received by the applicant no later than 45 days after the date that this notice of proposed rulemaking is published in the Federal Register.

Within ten (10) days of receiving the request, the applicant must send a written response to the person seeking access. The response must either provide the documents requested (or state that the document will be provided no later than ten days after the date of the response), or state that access has been denied. If access is denied, the response shall state witn particularity the reasons for its refusal. The applicant's response must be provided via express mail.

The person seeking access may then request a Commission hearing for 'he purpose of obtaining a Commission order directing the design certification applicant to disclose the requested information. The person must include copies of the original request (and any subsequent clarifying information provided by the person requesting access to the applicant) and the applicant's response.

The Comission will base its decision solely on the person's original request (including any clarifying infomation provided to the applicant by the person requesting access), and the applicant's response. Accordingly, a person seeking access to proprietary information should ensure that the request sets forth in sufficient detail and particularity the information required to be included in the request. Similarly, the mplicant should ensure that its response to any request states with sufficio detail and particularity the reasons for its refusal to provide the requested information.

80

If the Commission orders access in whole or part, the Commission will specify the date by which the requesting party must file with the Commission written comments and any request for an informal hearing before a licensing ,

board as discussed in Section V.C. above. A request for an informal hearing must meet the requirements set forth above in 3ection V.C., in particular the requirements governing the content of the hearing request, and shall be governed by the procedures and standards governing such requests set forth in Section V.C.

2. Access to Proprietary Information in a Hearing Parties who are granted a hearing may request access to proprietary information. Parties must first request access to proprietary information regarding the proposed design certification from the applicant. The request sha11 state with particularity:

(1) The nature of the proprietary information sought, (ii) The reason why the nonproprietary information currently available to the public in the NRC's Public Document Room is insufficient to prepare for the hearing, (iii) The relevance of the requested information to the hearing issue (s) for which the party has been admitted, and (iv) A showing that the requesting party has the capability to understand and utilize the requested information.

The request must be filed with the applicant no later than the date established by the Commission for filing discovery reauests with the licensing board.

If the applicant declines to provide the information sought, within 10 days.cf receiving the request the applicant must send a written response to 81

. . _ _ _ . _ ~ _

the requesting party setting forth with particularfty the reasons for its refusal . The party may then request the licensing board to order disclosure.

The party must include copies of the original request (and any subsequent clarifying information provided by the requesting party to the applicant) and the applicant's response. The licensing board shall bass its decision solely on the party's original request (including any clarifying information provided by the requesting party to the applicant), and the applicant's response.

Accordingly, a party requesting proprietary information from the applicant i should ensure that its request sets forth in sufficient detail and particularity the information required to be included in the request. Similarly, the applicant should ensure that its response to any request states with sufficient detail and particularity the reasons for its refusal to provide the requested information. The licensing board may order the Applicent to provide access to some or all of the requested information, subject to an appropriate non-disclosure agreement.

F. Ex Parte and Separation of Functions Restrictions Unless the formal procedures of 10 CFR Part 2, Subpart G are approved for a formal hearing in the design certification rulemaking proceeding, the NRC staff will not be a party in the hearing and separation of functions limitations will not apply. The NRC staff may assist in the hearing by answering questions about the FSER put to it by the licensing board, or to provide additional information, documentation, or other assistance as the licensing board may request. Furthermore, other than in a formal hearing, the NRC staff shall not be subject to discovery by any party, whether by way of interrogatory, deposition, or request for production of documents.  ;

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Second, the Commission has determined that once a request for an informal i or formal hearing is received, certain elements of the ex parte restrictions in 10 CFR 2.780(a) will be applicable with respect to the subject matter of that hearing request. Under these restrictions, the Commission wf11 communicate with interested persons / parties, the NRC staff, and the licensing board with respect to the issues covered by the hearing request only through docketed, publicly-available written communications and public meetings. Individual Commissioners may communicate privately with interested persons and the NRC staff; however, the substance of the communication shall be memorialized in a document which will be placed in the PDR and distributed to the licensing board and relevant parties.

4 VI. FINDING OF NO SIGNIFICANT ENVIRONMENTAL IMPACT: AVAILABILITY The Commission has determined under NEPA and the Commission's regulations in 10 CFR Part 51, Subpart A, that this proposed design certification rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and therefore an environmental impact statement (EIS) is not required. The basis for this determination, as documented in the environmental assessment, is that the amendment to 10 CFR Part 52 would not authorize the siting, construction, or operation of a facility using the System 80+ design; it would only codify the System 80+ design in a rule. The NRC will ecaluate 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.

83 l

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)

In addition, as part of the environmental assessment for the System 80+

design, the NRC reviewed pursuant to NEPA, ABB-CE's evaluation of various design alternatives to prevent and mitigate severe accidents that was submitted in ABB-CE's " Technical Support Document for the System 80+.' The Comission finds that ABB-CE's evaluation provides a sufficient basis to conclude that there is reasonable assurance that an amendmant to 10 CFR Part 52 certifying the System 80+ design will not exclude a severe accident design alternative for a facility referencing the certified design that would have been cost beneficial had it been considered as part of the original design certification application. These issues are considered resolved for the System 80+ design.

The environmental assessment, upon which th9 Comission's finding of no significant impact is based, and the Technical Support Document for the System 80+ are available for examination and copying at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. Single copies are also available from Mr. Harry Tovmassian, Nailstop T-9 f33, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555, (301) 415-6231.

VII. PAPERWORK REDUCTION ACT STATEMENT This proposed ruie amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements. The public reporting burden for this collection of information is zero hours. Send soments regarding this burden estimate or any other aspect of this collection of information, including 84

suggestions for reducing this burden, to the Information and Records Management Branch (T 6-F33), U.S. Nuclear Regulatory Commission, Washingten DC.

20555-0001; and to the Desk Officer, Office of Information and Regulatory Affairs,NE08-10202,(3150-0151), Office of Management and Budget, Washington, DC 20503.

Vill. REGULATORY ANALYSIS The NRC has not prepared a regulatory analysis for this proposed rule.

The NRC prepares regulatory analyses for rulemakings that establish generic regulatory requirements. Design certifications are not generic rulamakings.

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 oe useful because the design to be certified is proposed by the applicant rather than the NRC. For these reasons, the Commission concludes that preparation of a regulatory analysis is neither required nor appropriate.

IX. REGULATORY FLEXIBILITY ACT CERTIFICATION in accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C.

605(b), the Commission certifies that this proposed rulemaking will not have a significant economic impact upon a substantial number of small entities. The proposed. rule provides standard design certification for a light water nuclear power plant design. Neither the design certification applicant, nor nuclear 85

power plant licensees who referen:e this design certification rule, fall within ,

the scope of the definition of "small entities' set forth in the Regulatory i Flexibility Act,15 U.S.C. 632, or the small Business Size Standards set out in regulations issued by the Small Business Administration in 13 CFR Part 121.

Thus, this rule does not fall within the purview of the act.

X. BACKFIT ANALYSIS The Commission has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule becauf.e thase amendments do not imtSee requirements on existing 10 CFR Part 50 licensees. Therefcre, a backfit analysis was not prepared for this rule.

I list of Subjects in 10 CFR Part 52 Part 52 - Administrative practice and procedure, Antitrust, Backfitting, Combined license, Early site permit, Emergency planning, Fees, Incorporation by reference, Inspection, Limited work authorization, Nuclear power plants and reactors, Probabilistic risk assessment, Prototype, Reactor siting criteria, Redress of site, Reporting and recordkeeping requirements Standard design, Standard design certification.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553; the NRC proposes to adopt the following amendment to 10 CFR Part 52.

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1. The authority citation for 10 CFR Part 52 continues to read as follows: {

i AUTHORITY: Secs. 103, 104, 161, 182, 183, 186, 189, 68 Stat. 936, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 1244, as amended (42 U.S.C.

2133, 2201, 2232, 2233, 2236, 2239, 2282); secs. 201, 202, 206, 88 Stat. 1243, 1244, 1246, 1246, as amended (42 U.S.C. 5841, 5842, 5846).- t

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

l 5 52.8 Information collection requirements: OMB approval.

4 (b) The approved information collection requirements contained ir, this part appear in il 52.15, 52.17, 52.29, 52.45, 52.47, 52.57, 52.75, 52.77, 52.78, 52.79, Appendix A, and Appendix B.

3. A new Appendix B to 10 CFR Part 52 is added to read as follows:

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

1. Scope, s 87 i

--. . . , , , ._.~s .. , . - . - . , - - - . . , . - - , - -

This Appendix constitutes the standard design certification for the j System 80+! design, in accordance with 10 CFR Part 52, Suopart 8. The  !

applicant for certification of the System 80+ design was Combustion Engineering, j

Inc.(A88CE).

l 2.- Definitie.s.  !

As used in this part: t (a) Desfan control document (DCD) means-the master document that contains the Tier 1 and Tier 2 information that is incorporated by reference into this design certification rule. ,

(b) Tier 1 means the portion of the design-related information contained ,

in the DCD that is certified by this design certification rule (hereinafter  ;

, lier-1 information). Tier 1 information consists of:

' (1) Definftions and general provisions, f (2) tertified design descriptions, (3) Inspections, tests, analyses, and acceptance criteria-(ITAAC),  ;

(4) Significant-site parameters, and (5) Significant interface requirements.

The certified design descriptions, interface requirements, and site parameters are derived from Tier-2 infomation. ,

(c) Tier 2 means the portion-of the design related information contained

- in the DCD that is approved by this design certification rule (hereinafter  ;

-Tier 2information). Tier 2 information includes:  ;

(1) The-information required by 10 CFR 52.47, System 80+" is a trademark of Combustion Engineering, Inc.

88 f

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% ,v+- +%-w-.e4, -u.-e w-- ~ ~ ,.---i..,-..-.r --,e.,. r-w-iie.,- -me.-v., +--,-,-e-w .--#,eum-.-c.--w,w..-w.wegmw-e-.%, - - - .a

(2) The information required for a final safety analysis report under 10 CFR50.34(b),and (3) Supporting information on the inspections, tests, and analyses that will be performed to demonstrate that the acceptance criteria in the ITAAC have been met.

(d) Tier t* means the portion of the Tier 2 information which cannot be  ;

changed without prior NRC approval. This information is identified in the DCD.

(e) All other tems in this rule have the meaning set out in 10 CFR 50.2,10 CFR 52.3, or Section 11 of the Atomic Energy Act of 1954, as amended, as applicable.

3. (Reserved).
4. Contents of the design certification.

(a) Both Tier 1 and Tier 2 of the System 80+ Design Control Do:ument, ABB-CE, Revision 1, February 1995 are incorporated by reference. This incorporation by reference was approved by the Director of the Office of the Federal Register on (Insert date of approval) in accordance with 5 U.S.C. 552(a) and 1 CFR Part $1. Copies of the System 80+ DC0 may be obtained from (Insert name and address of applicant or organization designated by the applicant).

Copies are also available for examination and copying at the NP.C Public Document Room, 2120 L Street NW, Washington, DC 20555, and for examination at the NRC Library, 11545 Rockville Pike, Rockville, Maryland 20582-2738.

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(b) An applicant for a construction permit, operating license, or combined license that references this design certification must reference both Tier 1 and Tier 2 of the System 80+ DCD.

(c) If there is a conflict between the System 80+ DCD and either the application for design certification for the System 80+ design or NUREG-1462

' Final Safety Evaluation Report related to the Certification of the System 80+

Design,' dated August 1994 (FSER), then the System 80+ DCD is the controlling document.

5. Exemptions and applicable regulations.

(a) The System 80+ design is exempt from portions of the following regulations, as described in the FSER (index provided in Section 1.6 of the FSER):

(1) Section VI(a)(2) of Appendix A to 10 CFR Part 100 - Operating Basis Earthquake Design Consideration; (2) Section (b)(3) of 10 CFR 50.49 - Environmental Qualification of Post-Accident Monitoring Equipment; (3) Section (f)(2)(iv) of 10 CFR 50.34 - Separate Plant Safety Parameter Display Console; (4) Section (f)(2)(viii) of 10 CFR 50.34 - Post-Accident Sampling for Hydrogen, Boron, Chloride, and Dissolved Gases;

-(5) Section (f)(3)(iv) of 10 CFR 50.34 - Dedicated Containment Penetration; (6) Section !!!.A.I.(a) of Appendix J to 10 CFR 50 - Containment Leakage Testing; and 90

(7) Sections (f)(2)(vii), (viii), (xxvi), and (xxviii) of 10 CFR 50.34 - l Accident Soui , (erms.

i (b) Except as indicated in paragraph (c) of this Sectica, the regulations that apply to the System 80+ design are those regulations in 10 CFR f Parts 20,50,73,and100(August 1994),thatareapplicableandtechnically relevant, as described in the FSER.

(c) In addition to the regulations specified in paragraph (b) of this Section, the following regulations are applicable for purposes of 10 CFR 52.48, .

52.54, 52.5g and 52.63:

e (1) In the standar1 design, the effects of intersystem loss-of-coolant accidents must be minimized by d signing low-pressure piping systems that interface with the reactor coolant pressure boundary to withstand full reactor l coolant system pressure to the extent practical.

(2)(1) Piping systems associated with pumps and valves subject to the test requirements set forth in 10 CFR 50.L5a(f) must be designed to allow for (A) Full flow testing of pumps and check valves at maximum design flow, and (B) Testing of motor operated valves under maximum achievable differential pressure, up to design basis differential pressure, to demonstrate the  :

capability of the valves to operate under design basis conditions.

(ii) For pumps and valves subject to the test requirements set forth in 10 CFR 50.55a(f), an applicant for a combined license which references this

., standard design certification rule shall-submit, as part of the application:

(A) a program for testing _ check valves that incorporates the use of advanced non-intrusive techniques to detect degradation and monitor performance characteristics, and 91

  • s (B) a program to determine the frequency necessary for disassembly and inspection of each pump and valve to detect degradation that would prevent the component from performing its safety function and which cannot be detected through the use of advanced non-intrusive techniques. The licensee shall ,

implement these programs throughout the service life of the plant.

(3) For digital instrumentation and control systems, the design must include (1) An assessment of the defense-in-depth and diversity of instrumentation and control systems; (ii) A demons 4ation of adeque.te defense against common-mode failures; and (iii) Provisions for independent backup canual controls and displays for critical safety functions in the control room.

(4) The electric powei system of the standard design must include an alternate power source that has sufficient capacity and capability to power the necessary complement of non-safety equipment that would most facilitate the ability of the operator to bring the plant to safe shutdown, following a loss of the normal power supply and reactor trip.

(5) The electric power system of the standard design must include at least one offsite circuit supplied directly from one of the offsite power sources to each redundant safety division with no intervening non-safety buses in such a manner that the offsite source can power the safety buses upon a failure of any non-safety bus.

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(6)(1) The requirements of 10 CFR 50.48(a): and 10 CfR Part 50, Appendix R,Section III G.I.a. apply to all structures, systems, and components important to cafety.

(ii) Notwithstanding any provision in paragraph (1) of this section, all structures, systems, and components important to safety in the standard design must be designed to ensure that:

(A) Safe shutdown can be achieved assuming that all equipment in any one fire area will be rendered inoperable by fire and re-entry into that fire area for repairs and operator actions is not possible, except that this provision does not apply to (1) the main control room, provided that an alternative shutdown capability exists and is physically and electrically independent of the main control room, and (2) the reactor containment; (B) Smoke, hot gases, or fire suppressant will not migrate from one fire area into another to an extent that could adversely affect safe-shutdown capabilities, including operator actions; and (C) in the reactor containment, redundant shutdown systems are provided with fire protection capabilities arid means to limit fire damage such that, to the extent practicable, one shutdown d;eision remains free o; fire damage.

(7) The standard design must include and an applicant for a combined license which references this standard design certification rule shall submit as part of the application:

(i) The description of the reliability assurance program used during the design that includes scope, purpose, and objectives;

'For the standard design, the footnote reference in 10 CFR 50.48(a) to Branch Technical Position Auxiliary Power Conversion System Branch BTP APCSB9.5-1,

" Guidelines for Fire Protection for Nuclear Power Plarts," will be to the July, 1981 version.

93

. . - -- -a - -

(11) The process used to evaluate and prioritize the structures, systems, and components in the design, based on their degree of risk-significance; (iii) A list of structures, systems, and components designated as risk-significant; and (iv) For those structures, systems, and components designated as risk-significant (A) A process to deterstne do:afnknt failure modes that considered industry experience, analytical models, and applicable requirements; and (B) Key assumptions and risk insights from probabilistic, deterministic, and other methods that considered operation, maintenance, and monitoring activities.

(8) The probabilistic risk assessment .'equired by 10 CFR 52.47(a)(1)(v) must include an assessment of internal and external events. For external events, sitsplified probabilistic methods and margins methods may be used to assess the capacity of the standard design to withstand the effects of events such as fires and earthquakes. Traditional probabilistic techniques should be used to evaluate internal floods. For earthquakes, a seismic margin analysis must consider the effects of earthquakes with accelerations approximately one and two-thirds the acceleration of the safe-shutdown earthquake.

(9) The standard design must include an on-site alternate ac power source of diverse design capable of powering at least one complete set of equipment necessary to achieve and maintain safe-shutdown for the purposes of dealing with station blackout.

(10)(1) The standard design must include the featuras in paragraphs (A) -

(C) below that reduce the potential for and effect of interactions of molten core debris with containment structures:

94

(A) Reactor cavity floor space to enhance debris spreading; (B) A means to flood the reactor cavity to assist in the cooling process; and (C) Concrete to protect portions of the containment liner and other structural members. .

(ii) The features required by paragraph (1) of this section, in combination with other features, must ensure for the most significant severe accident sequences that the best-estimate environmental conditions (pressure and temperature) resulting from core-concrete interaction do not exceed ASME Code Service Level C for steel containments or Factored Load Category for concrete containments for approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

- (11) The standard design must include: (1) a reliable means to depressurtre the reactor coolant system and (ii) cavity design features to reduce the amount of ejected core debris that may reach the upper containment.

(12) The standard design must include analyses based on best-available methods to detonstrate that (i) Equipment, both electrical and mechanical, needed to prevent and mitigate the consequences of severe accidents is capable of performing its function for the time period needed in the best-estimate environmental conditions of the severe accident (e.g., pressure, temperatures radiation) in which the equipment is relied upon to function; and (ii) Instrumentation needed to monitor plant conditions during a severe accident is capable of performing its function for the time period needed in the >

best-estinste environmental conditions of the severe accident (e.g., pressure, temperature, radiation) in which the instrumentation is relied upon to functiort.

95

_(13) The standard design must include features to limit the conditional containment failure probability for the more likely severe accident challenges.

(14)(1) The standard design must include a systematic examination of features in relation to shutdown risk assessing:

(A) Specific design features that minimize shutdown risk; (B) The reliability of decay heat removal systems; (C) Vulnerabilities introduced by new design features; and (D) Fires and floods occurring with the plant in modes other than full power.

(ii) An applicant for a combined license wnich references this design certification rule shall submit as part of the application a description of the program for outage planning and control that ensures:

(A) The availability and functional capability during shutdown and low poucr operations of features important to safety durtng such operations; and (B) The consideration of fire, flood, and other hazards during shutdown and low power operations. The licensee shall implement this program throughout the servit.,. life of the plant.

(15) The standard design must include a best-estimate, systematic evaluation of the plant response to a steam generator tube rupture (SGTR) to:

(i) Identify potential design vulnerabilities, and (ii) Assess potential design improvements to mitigate the amount of containment bypass leakage that could result from a SGTR.

6. Issue resolution for the design certification, 96

- -=. -- . - . _ . - -

-(a) All nuclear safety issues associated with the information in the FSER or DCD are resolved within the meaning of 10 CFR 52.63(a)(4).

(b) All environmental issues associated with the information in the NRC's Environmental Assessment for the System 80+ design or the severe accident design alternatives in Revision 2 of the Technical Support Document for the System 80+ dated January 1995 are resolved within the meaning of 10CFR52.63(a)(4).

7. Duration of the design certification.

This design certification may be referenced for a period of 15 years from (insert date 30 days after publication in the Federal Register), except as provided for in 10 CFR 52.55(b) and 52.57(b). This design certification remains valid for an applicant or licensee that references this certification until their application is withdrawn or their license expires, including any period of extended operation under a renawed license.

8. Change process.

(a) Tier 1 information.

(1) Generic (rulemaking) changes to Tier 1 information are governed by the requirements in 10 CFR 52.63(a)(1).

(2) Generic changes to Tier 1 information are applicable to all plants referencing the design certification as set forth in 10 CFR 52.63(a)(2).

97

(3) Changes from Tier 1 infomation that are imposed by the Comission through plant-specific orders are governed by the requirements-in 10 CFR 52.63(a)(3).

(4) Exemptions from Tier 1 infomation are governed by the requirements in 10 CFR 52.63(b)(1).

(b) Tier 2 infomation.

(1) Generic changes to Tier 2 information are governed by the requirements in 10 CFR 52.63(a)(1).

(2) Generic changes to Tier 2 information are applicable to all plants referencing the design certification as set forth in 10 CFR 52.63(a)(2).

(3) The Comission may not impose new requirements by plant-specific order on Tier 2 information of a specific plant referencing the design l

certification while the design certification is in effect under il 52.55 or 52.61, unless:

(i) A modification is necessary to secure compliance with the Comission's regulations applicable and in effect at the time the certification was issued, or to assure adequate protection of the public health and safety or the comon defense and security; and (ii) Special circumstances as defined in 10 CFR 50.12(a) are present.

(4) An applicant or licensee who references the design certification may request an exemption from Tier 2 information. The Comission may grant such a request only if it detemines that the exemption will comply with the requirements of 10 CFR 50.12(a). The granting of an exemption on request of an applicant must be subject to litigation in the same manner as other issues in the conttruction permit, operating license, or combined license hearing.

l l

98 i j

- - -. . . .- . -- . - - - . - . - -.. ..- . ~

4 (5)(i) An applicant or licensee who references the design certification may depart from Tier 2 information, without prior NRC approval, unless the proposed change involves a change to Tier 1-or Tier 2* information, as ,

identified in the DCD, the technical specifications, or an unreviewed safety ,

question as defined in paragraphs (b)(5)(ii) or (b)(5)(iii) of this section.

When evaluating the proposed change, an applicant or licensee shall consider all matters described in the DCD, including generic issues and shutdown risk for all rostulated accidents including severe accidents. These changes will no longer be considered " matters resolved in connection with the issuance or renewal of a design certification" within the meaning of 10 CFR 52.63(a)(4).

(ii) A proposed departure from Tier 2 information, other than severe accident issues identified in Section 19.11 of the DCD, including appendices 19.llA through 19.llt, must be deemed to involve an unreviewed safety question if:

(A) The probability of occurrence or the consequences of an accident or malfunction of equipment important to safety previously evaluated in the DCD may be increased; (B) A possibility for an accident or malfunction of a different type than any evaluated previously in the DCD may be created; or (C) The margin of safety as defined in the basis for any technical specification is reduced.

(iii) A proposed departure from information associated with-severe accident issues identified in Section 19.11 of the DCD, including appendices 19.llA through 19.llt, must be deemed to involve an unreviewed-safety question if:

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_ . _ _ . _ . - . ._ _ _ - _ _ - . _ _ _ _ _ _ . ~ - - . .

a ,

(A) There is-a substantial increase in the probability of a severe accident such that a-particular severe accident previously reviewed and

- detenmined to be not credible could become credible; or (8) There is a substantial increase in the consequences to the public of a ,

particular severe accident previously reviewed.

(iv) Departures from Tier 2 information made in accordance with Section 8(b)(5) above do not require an exemption from this design certification rule.

-(c) Other requirements of this design certification rule.

An applicant or licensee who references the design certification may not depart from this rule's requirements, other than Tier 1 or 2 information, other than by an exemption in accordance with 10 CFR 50.12.

9. Records and Reports.

(a) Records.

(1) The applicant for this design certification shall maintain' a copy of the DCD that includes all generic changes to Tier 1 and Tier 2 information.

(2) An applicant or licensee that references this design certification shall maintain records of all changes to and departures from the DCD pursuant to Section 8 of this Appendix. Records of changes made pursuant to Section 8(b)(5)

- must include a written safety evaluation which provides the bases for the determination that the proposed change does not invalve an unreviewed safety question, a change to Tier 1 or Tier 2* information, or a change to the technical: specifications.

100 4-a - _ - - u_ _ - u _a_- - - - -

_ a ,-y- ,-, - - -w m ,

- - - - ., 4 .m , , .

(b) Reports. An applicant or licensee that references this design

. certification shall submit a report to the NRC, as specified in 10 CFR 50.4, containing a brief dercription of any departures from the DCD, including a summary c 2%e safety evaluation of each. An applicant or licensee shall also submit updates to the DCD to ensure that the DCD contains the latest material developed for both Tier I and 2 information. The requirements of 10 CFR 50.71 for safety analysis reports must apply to these updates. These reports and updates must be submitted at the frequency specified below:

(1) During the interval from the date of application to the date of issuance of either a construction permit under 10 CFR Part 50 or a combined license under 10 CFR Part 52, the report and any updates to the DCD may be submitted along with amendments to the application.

(2) During the Interval from the date of issuance of either a construction permit under 10 CFR Part 50 or a combined license under 10 CFR Part 52 until the applicant or licensee receives either an operating license l

under 10 CFR Part 50 or the Commission makes its findings under 10 CFR 52.103, the report must be submitted quarterly. Updttes to the DCD must be submitted anneally..

(3) Thereafter, reports and updates to the DCD may be submitted annually or along with updates to the safety analysis report for the facility as required by 10 CFR 50.71, or at such shorter intervals as may be specified in the license.

101

(c) Retentfon period. The DCD and the records of changes to and I

departures from the DCD aust be maintained until the date of termination of the construction permit or license.

Dated at Rockville, Maryland, this ' day of //fA4 M , 1995.

For the Nuclear Regulatory Comission.

Jo . Hoyle,'

S tary of the Commission 4

s 102 l

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