ML20080B967

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Overall Review Strategy for the Nuclear Regulatory Commissions HIGH-LEVEL Waste Repository Program
ML20080B967
Person / Time
Issue date: 11/30/1994
From: Rachel Johnson
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
FACA, NUREG-1495, NUDOCS 9412070075
Download: ML20080B967 (39)


Text

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} Y r 1 NUREG-1495:- 1 Overall Review Strategy forEtheL Nuclear Regulatory Commission's a High-Level Waste Repository L Program j j a t UeS. Nuclear Regulatory Commission -t .Omce of Nuclear Material Safety and Safeguards R. L. Johnson l i l gp" ** coq l k y) l i.:d in focusing NRC's and pre-LA reviews. Section 4.0 describes the strategies reviews on DOE's repository rrogram at the Yucca for developing the LA and pre-LA review capability, and Mountain site. Section 5.0 describes how all the strategies will be im-plemented. Statutory requirement of particular relevance to the ORS are further described in Appendix A. 2

SUMMARY

OF EXISTING 2.2 Summary of Appl cable Regulatory i REQUIREMENTS, POLICY, AND Requ.irements and Gu. dance i ASSUMPTIONS APPLICABLE TO TIIE OVERALL REVIEW The Commission has promulgated regulations dealing STRATEGY with aH asputs of the dhposal of EW in gmlogipey tories. Ihese regulations are contained prmcipally m 10 CFR l' art 60, but also include provisions in Part 2 relat-Statutory requirements of NWPA, and the NWPA, as ng to procedural aspects of the LA review process and amended in 1987, together with regulatory requirements provisions in l' art 51 pertaining to implementation of the of 10 CFR Part 2 and Part 60, provide a basis for the ORS. National Environmental Policy Act (NEPA). The regula-In addition, regulatory guidance and existmg pohey m the tions, which conform to the requirements of Section 121 form of NRC's Five-Year Plan, RS and updates, existmg (b) of NWPA, address certain pre-LA reviews as well as review plans, and procedural agreements with DOE con" the consideration of the LA. Other regulations that might tribute to the ORS. Many of the spectfic strategies de-influence the design of the HLW repository are 10 CFR scribed in Sections 3.0 and 4.0 are based on existing re-Parts 71 (transportation) and 72 (fuel cycle facilities). quirements and policy. The applicable requirements and 'Ihese regulations could influence the design of the liLW policy are summarized below and discussed m more detail repository through the natural interfaces among the m Appendix A. transportation and interim storage facilities and the re-pository, particularly with regard to the design require-2.1 Summary of Applicable Statutory mmts of 10 CFR Part 6(' Appendtx A provides further descriptions of applicable regulatory requirements and Requirements guidance. NRC's licensing and related regulatory authority is de-fined by the Atomic Energy Act of 1954 as amended.This 2.3 Summary of Aaplicable Existing authority is made applicable to DOE (as successor to the Policy Energy Research and Development Administration) un-der Sectien 2020f the Energy Reorganization Act of 1974. NRC's existing policies re3ted to reviews exist in many Congress further defined the NRC's role as it related to documents, including the Five-Year Plan, RS and up-the disposal of IILW in geologic repositories in NW PA, as dates, Division of Iligh-Level Waste Management amended. (HLWM) review plans, and the NRC-DOE procedural agreements. In addition, general agency and HLWM The staff's LA review is based on the NWPA requirement practice has also been a major contributor to formulating that the Commission make a construction authorization the ORS. Much of the ORS is built upon this foundation decision within 3 years following DOE's required submit-of policy and practice that has evolved over years of pro-tal of the LA to NRC. A provision allows for a 1 year gram implementation. extension,if necessary. 2.4 Major Assumptions The staff's pre-LA reviews are also based on NWPA pro-visions for: 1) commenting on DOE's Mission Plan, Site The degree to which the four major assumptions listed Characterization Plan, and sufficiency of site character-below are actually achieved will contribute to the effec-ization analyses and waste form proposal: 2) concu rring on tiveness of the ORS. the need, if proposed, for DOE use of radioactive mateci-als in site characterization: and 3) providing input to 1. Much of the information in tha LA and references DOE's Project Decision Schedule (PDS). supporting the LA (inct uding interfaces between the NUREG-1495 4

repository and other systems) will be developed and Pre-License Application Review Objectires documented by DOE during the pre-LA phase and, therefore, will be available, in preliminary form, for 1. Conduct reviews that support streamlining the LA the staff's pre-LA review. This includes complete acceptance and comphance reviews. access to data and documents prepared by DOE, ccmsistent with the NRC-DOE procedural agree. 2. Conduct reviews and provide comments required by ments. This assumption is based on DOE's inten-NWPA and 10 CFR lbrt 60 (i.e., SCP, Mission Plan, tions expressed in its Site Characterization Plan PDS, and preliminary site characterization sufficien-1 (SCP) (DOE,1988) and its plans for developing the cy reviews)- LA Annotated Outline (AO) and topical reports (Roberts,1992);. 3. Conduct reviews requested by DOE or agreed to j between the staff and DOE (e.g., study plan re-2. DOE's preliminary performance allocations and dews); performance assessments will be available for 4. Conduct reviews to identify concems that might be pre-LA reviews; potential licensing issues and comment on DOE's resolution of these concerns to help ensure that 3. The staff's review guidance and interactions with DOE submits a complete LA that will be acceptable DOE will be successful in leading DOE to resolve for docketing and conducting the LA review; staff concerns and reflect resolution in the LA (reso-lution of concerns is at the staff level and such con-5. Conduct reviews to identify concerns with DOE's cerns can be raised in licensing); compliance with the site characterization require-ments of Subpart B of 10 CFR Part 60 (e.g., use of 4. The State of Nevada and other intcrested parties will radioactive materials and adverse effects on waste participate technically so that the staff will be able to isolation capability of the site). consider technical concerns of other parties during its pre-LA and LA reviews. 3.2 StrategicS 3 OBJECTIVES AND STRATEGIES This s eti n discusses the LA and pre-LA strategies that the staff will use to achieve the objectives stated above. FOR PRE-LICENSE Strategies for LA review are given first to emphasize the APPLICATION AND LICENSE importance of the LA review in guiding other program APPLICATION REVIEWS activities. License Application Review Strategies 3.1 Obj.ectives The following five strategies will be used by the staffin its All the staff's reviews shoiJ be ca.sistent with the appli-review of the LA: cable statutory and reguktary requirements and should not delay the implementatia of DOE's program (in the L Conduct a two-phase review consisting of an initial absence of unresolved safety concerr.s). In particular, LA acceptance review followed by a compliance review; and pre-LA reviews should support the objectives stated below. Objectives for LA reviews are given first to empha-2. Use compliance reviews to verify the acceptability of size the importance of the LA reviews in guiding other DOE's compliance demonstrations; program activities. 3. Use results of the pre-LA reviews and supporting investigations; License Application Review Objectives 4. Use a systematic, audit approach for compliance re-Conduct a review to determine the completeness and views and prioritize these reviews by focusing on acceptability of DOE's LA and document the findings areas most important to repository performance with respect to compliance with 10 CFR Part 60 in the (i.e., compliance with 10 CFR Part 60 performance SER within the first 18 months from when the LA is objectives); docketed so that the Commission an make its construc-tion authorization decision within the last 18 months, in 5. Select from four types of compliance reviews,includ-order to comply with the 3-year NWPA-mandated time ing staff analyses and testing for the systematic, audit period. approach; 5 NUREG-1495

A description and rat 10nale ior each stcategy is given 3 Use results ofIhepre-LA reviews and supportinginvesti-below. gations. L Conduct a two-phase review consisting of an initial Reports prepared by DOE during the pre-LA phase and acceptance reviewfollowed by a compliance revie* referenced in the LA will include a substantial amount of detailed technical information such as data, methodolo-Upon submittal of the LA by DOE, the staff will conduct gies, detailed analyses, and data interpretations. The staff an acceptance review to determine if the LA is complete will conduct pre-LA reviews of some of these supporting and acceptab!c for docketing.'Ilis review will focus on the reports. Therefore, where information in these reports inclusion, in the LA, of those technical and procedural has been reviewed and found acceptable, it will ordinarily elements that are defined in 10 CFR 60.21 and 60.22 that not need to be reviewed again during the LA compliance may affect the issuance or denial of a construction autho-review, unless additional information calls into question rization. If the LA is not complete, docketing will be the staff's earlier reviews. However, the staff will review denied until DOE provides such additional information as how the information is used in demonstrating compliance. may be required for the LA to be docketed. Furthermore, the staff will have reviewed DOE's license application annotated outline (LAAO) and topical re-The staff's use of the acceptance review is required by ports. 'Ihe staff will continue to review DOE's annual 10 CFR 2.101(f). In addition, the acceptance review is revisions of its LAAO and document concerns, as neces-expected to contribute significantly to meeting the sary. In addition, DOE can request the staff to review one NWPA-mandated 3-year licensing time period by not or more issues, separately and prior to submittal of a starting the 3-year process until DOE submits the infor potential LA, by preparing a topical report.The NRC staff mation needed for a complete and acceptable LA. will review topical reports and will prepare a Safety Evalu-ation documenting the results of the reviewand the staff's Once the LA is docketed, the NWPA 3-year timetable will cceptance of the topical report, if the staff finds the begin, and the staff will conduct a compliance review over topical report acceptable for referencmg m the LA. At the next 18 months, to determine the acceptability of ! hat time, the staff would consider the matters presented DOE's demonstrations of compliance with the require-in the topical report to be resolved, at the staff level, unless new informanon became available. DOE will then ments of 10 CFR Part 60.The results of the compliance review will be documented as staff evaluation findings in be able to reference this topical report m its LAAO and the staff's SER. See Figure 2 for the LA review phases. ultimately, m its LA. In addition, quality assurance (QA) reviews and audits conducted during the pre-LA phase will give confidence that the information in the LA was 2 Use compliance reviews to rcrify the acceptability of obtained under an acceptable QA program. These staff DOE's compliance demonstrations. pre-LA technical and QA activities will be the basis for making preliminary sufficiency comments at the end of NRC's overall licensing philosophy is that the safe opera-the pre-LA phase, tion of any nuclear facility is the licensce's responsibility. In the case of the geologic repository program, DOE as the licensee will need to demonstrate that it can construct The staff concerns identified by its pre-LA reviews will continue to be documented in letters to DOE and are and operate a geologic repository for HLW in the manner defined in 10 CFR Part 60. identified as open items. All staff concerns are important for DOE to resolve; however, the staff might consider some to be critical to the staff's LA review, because lack of it is not the staff's responsibility to demonstrate com-acceptable DOE resolution would prevent the staff from ph,ance with the requirements m 10 CFR Part 60; that is conducting a meaningful review, or the Commission from DOE's statutory responsibility. 'Ihis review strategy rec-making a decision regarding construction authorization, ognizes that the staff will need to conduct the necessary within the 3-year statutory time period. For this reason, reviews and supporting activities to gain confidence that the staff considers this type of concern to be an objection the conclusions reached by DOE m, its license application to LA submittal. Concems regarding lack of adequate lead to an acceptable demonstration of compliance with information to be able to evaluate Key Technical Uncer. 10 CFR Part 60. However, the staff will not duplicate all tainties or other concerns that would need a long time to DOE's demonstrations. Rather, m the manner defmed by resolve, such a new or additional testing or development the individual review plans, the staff will undertake re-of new or revised analytical methods. arc examples of this views to verify and document, through Evaluation Find-type of objection. ings, DOE's compliance demonstrations (see Figure 3). I 'Ihis strategy is consistent with NRC's statutory licensing role. Example evaluation findings are further discussed in The staff will track DOE's resolution of all conceras, in Section 2 of Appendix A. particular objections to LA submittal. In Section 1.6.2 of NUREG-1495 6

l l Calendar Year l 88 l 89 l 90 l 91 l 92 l 93 1 94 1 95 l 96 I 97 l 98 1 99 l 00 l 01 l 02 1 03 I 04 1 05 l l DOE SCP Progress Reports - every 6 rnonths W m g 5 Y DOE Study Plans e PLAN REVIEWS h '( k S a Sc^ Q TESTING, DESIGN, AND PERFORMANCE ASSESSMENT REVIEWS N? \\' c. cE DEIS FEIS SRR S V VU h y PREUMINARY y P SUFFICIENCY REVIEW r> Le9end-s O e CA-Construction Authorization 8, DOS - Draft Environmental Imped Statement Prelim. S% LA Submittal r FEIS - Final Erwironmental Irnpact Statement Comments to DOE V E t.A-Limnae Application 9 SCA - Site Characterization Analysis LA REVIEW Fj SCP -See Characterization Plan SER-Salety Evaluation Report Q Q o=y SRR - Site Recommendation Report Aww Review Compliance h ? Dockee.nD SER p p DoEusestones Decision liEARING 0 NRC uneetone. 0 Y CompletedMilestones Annual Repos CA Decs To Congress Z C PRE M PHASES UCENSING PHASES

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I I I I I I EVALUATION FINDINGS FOR SUPPORTING EVALUATION FINDINGS l 10 CFR 80.31 FOR LARP CHAPTERS I I 8 g= 0 I j g f: . -~l q _i -t 1 -l l l!lll m I i I s l 15 I al O m g I i I ls3 E 5 ~ j e m I I I I g 1l8[2 g i s8 g I d "h l I I I I 8 3 i M 8 ~ l I I l s o e _a l 3 I I I I

i I its FCRO, the staff has asked that DOE provide the status follow the LARP unless there is a justified change that has of any unresolved objections in its LA. As part of the been approved by management. 'lherefore, the areas and Acceptance Review of the LA and before a decision on types of reviews described in the LARP are the minimum docketing the LA, the staff will evaluate the effect of any review that the staff would do. Changes to refocus a re-unresolved objections, both individually and in combina-view might be justified to respond to new information, tion with others, on the staff's ability to conduct a mean-comments raised by other parties, or to go into more detail ingful compliance review or the Commission from making in order to adequately review a particular issue. Changes a decision regarding construction authorization within the may also be needed to place lesser emphasis on a review if 3-year statutory time period, an issue turns out to have less significance to performance than previously envisioned. 'Ihis strategy should streamline the acceptance review and result in compliance reviews that focus less on de. This review strategy not only ensures that the staff will tailed supporting information and methodologies and fo. conduct a complete review at a broad level, but also di-l cus more on how the detailed information was used to rects the staff to focus detailed attention on ' hose areas demonstrate compliance. Therefore, this strategy will most important to performance and that wit axely be the contribute to the effectiveness and efficiency of the LA areas most difficult to consider in licensing. Therefore, review and is considered essential for the staff to be abic this strategy is intended to enhance the effectiveness and to conduct its LA review in 18 months. efficiency of the staff's review. S ""'5**S""%P"*S'*P"""U'*I"'I"?E U 4. Use a systematic, audit approachfor compliance reviews S """I *" ""0 '"'5"E l ' ' 'Y*"** andprioritize these reviews byfocusing on areas most ""!"l"l& Y uudd OPPma important to repository performance (i.e., compliance with 10 CFR Part 60 performance objectives). The staff will select the type (s)of reviews from fourdiffer-ent types of compliance reviews and supportinginvestiga. ,Ihis review strategy consists of conducting a complete tions appropriate for the review priority determined by compliance review of the broad level ofinformation in the the systematic, audit approach described above, to deter-LA and more detailed reviews on an audit basis (in sc-mine compliance with 10 CFR Ibn 60.These review types lected areas), to determine if the detailed information are described in detail in Appendix B and are shown in supports DOE's demonstmtions in the LA. This strategy Figure 4. 'Iherefore, the selected detailed LA informa-can be envisioned as a " vertical slice" into the detailed tion will be reviewed in greater detail and further eval-levels. uated and verified, using the results of staffinvestigations. 'Ihese investigations might include analyses where the This strategy describes a method to prioritize the review staff uses the results of its own performance assessments by identifying the higher priority areas that will receive by applying either available nu merical models or models it more attention by the staff (see LA Review Strategy 5, has developed independe ntly. It should be emphasized below) Areas selected for detailed review will be primari-that the burden is completely on DOE to provide the data ly focu,cd on technical uncertainties judged to be most and assessments to support its performance assessments important to repository performance.The staff has devel-in the LA. In most cy.e,, the staff will rely on DOE data, oped and is applying criteria to systematically identify the independently reviewea by the staff, as input to the staff's technical uncertainties most important to repository per-performance assessments. In addition, Ihe results of staff formance (i.e., technical uncertainties that pose a risk of field or laboratory testing might also be used to either noncompliance with one or more of the performance ob-verify some of DOE's results or simply to gain an indepen-jectives of 10 CFR Ibrt 60). These are referred to as key dent understanding of a condition or process, to enhance technical uncertainties (see Figure 3, which lists the selec-the staff's ability to conduct detailed reviews. tion criteria, and Appendix H, which describes the selec-tion criteria, and defines the terms " technical uncertain-The technical reviews discussed above will be comple-ty" and " key technical uncertainty"). The staff's judgment mented by reviews of the QA information given in the LA in applying these criteria is supported by insights gained and the results of the staff's QA reviews and audits con-from reviews of DOE's program, staff performance as-ducted during the pre-LA phase (see LA Review Strategy sessments, and the work by other parties, including the 2, above). 'Ihese reviews are intended to give a level of concerns they raise. confidence that the information in the LA was developed under an acceptable OA program. This strategy also recognizes that because of the nature and complexities of the repository program, some flexibil. Finally, the variety of reviews and independent staffinves-ity must be maintained while conducting the staff's re. tigations described above will provide evaluations of view. 'lherefore, the staff has flexibility in how it applies DOE's program from different perspectives and different the L.ARP at the time of review; however, the intent is to levels of detail, resulting in complementary lines of 9 NUREG-1495

2 Cxm=Le TYPES OF UCENSE APPUCATION (LA) REVIEWS (SEMC7/ON CRITERIA) T INFORMATION REVIEW E DETAIL METHOD R ACCEPTANCE REVIEW (IA-REIATED) u REVIEW Y BROAD ONLY n COMPLIANCE REVIEWS f::, 5 GENERAL INFOMATION REVIEW SAFETY REVIEW (RADIOLOG/ CAL SAFE 7Y (GENERAL-INFORMATION RELATED) AND WASTE-ISOLATION RELATED) ~, R _1 5 DETAILED SAFETY REVIEW k SUPPORT BY ANALYSES 5 (HIGH POTENTIAL RISK OF D NON-COMPLIANCE WITH 5 PERFORMANCE 5 OBJECTIVES) M 8 5 DETAILED SAFETY REVIEW [5 SUPPORTED BY INDEPENDENT TEST, ANALYSES, AND OTHER S. INVESTIGATIONS Wii . (HIGH POTENTIAL RISK OF ? NON-COMPLIANCEAND MOST 5 DIFFICULT TO RESOLVE) n 2 lf ~ E V e INDEPENDENT TESTING DETAILED AND ANALYSES

l evidence regarding the acceptability of DOE's com-mented in topical reports, the AO for the LA, and Site pliance demonstrations in the LA.Therefore, this strate-Recommendation Report. The staff's preliminary site gy should improve the effectiveness of the staff's verifica-characterization sufficiency review, required by NWPA, tion and thus increase the staff's confidence in making willbeimportant in thisphase,toidentifypotentiatinsuf-findings. ficiencies that should be resolved by DOE. Phased reviews consistent with DOE's schedules are Pre-License Application Review Strategies needed so the staff can give timely guidance and avoid The following seven strategies will be used by the staffin delaying DOE's program, its pre-LA reviews: 2. Use a systematic, audit approach and focus technical 1. Conduct reviews consistent with the general phases reviews on supporting the pre-LA review objectives. and schedule of DOE's program; Technical reviews should focus on each of the pre-LA 2. Use a systematic, audit approach and focus technical review objectives identified in Section 3.1. The staff will reviews on supporting the pre-LA review objectives; not review all of DOE s activities nor all the data collected nor information developed by DOE. Instead, the techni-3. Conduct focused QA reviews and QA audits; cal reviews intended to support the LA reviews should take an audit approach and be prioritized, like the LA 4. Conduct reviews of DOE's issue resolution strategy reviews, on those key technical uncertainties most impor-and performance alk) cation process; tant to repository performance (see LA Review Strategy 4).They should also use similar types of reviews and sup-5. Conduct reviews of DOE's AO for the LA; porting investigations, as in LA Review Strategy 5. Sup-porting investigations, like the staff's iterative perform-ance assessment (IPA) activities conducted during the 6. Support reviews by documenting concerns as open pre-LA phase, either provide results that can be used in items and tracking DOE resolution of these open the LA reviews, or provide preliminary results supporting items, using a computer data base. the staff's pre-LA reviews.lhble 2 gives some examples to guide the staff in selecting the types of pre-LA reviews 7. Support reviews with open interactions with DOE and investigations that would support the different types and other parties, together with considering con-of IA reviews. As part of this strategy, the staff will also cerns of other parties. review DOE's resolution of the concerns documented by the staff (see pre-LA Review Strategy 6 on open item A description and rationale for each strategy is given tracking). Furthermore, concerns documented as a result below. of technical reviews, and that might lead to the staff not docketing the LA (i.e., objections to LA submittal)if not resolved by DOE, also will be considered by the staff, in L Conduct reviews consistent with the general pha.ses and preparing its prehmmary site characterization sufficiency schedule of DOE's activities. comments required by NWPA. During the pre-LA phase, DOE's activities can be grouped into three general phases, sequentially progress-Focused pre-LA reviews will be the basis for preparing the ing through 1) planning; 2) testing, design, and prelimi-preliminary site characterization sufficiency comments nary performance assessments; and 3) preparing the LA, required by NWPA. This will allow streamlining the ac-FEIS, and Site Recommendation Report. It is recognized ceptance review by either confirming that the LA is con-that activities in these three phases overlap and many are sistent with what was reviewed in the pre-LA phase or repetitive (e.g., annual preliminary performance assess-reviewing revised or new information. Furthermore, the ments). The staff's reviews will generally follow these reviews will streamline the LA compliance reviews, where three phases and, therefore, will initially emphasize re-detailed information in reports that will be referenced by viewing DOE plans such as the SCP and study plans. As the LA can be reviewed before LA submittal. Finally, DOE begins to implement these plans in its testing and even reviewing preliminary information that is expected design activities, the emphasis of the staff's reviews will to change before being presented or referenced by the LA shift accordingly. Finally, even though testing, designing, will both familiarize the staff with the information and and preliminary performance assessments continue, the improve the staff's capability to review this material dur-emphasis in the third phase will be reviewing DOE's final ing the LA review. Both of these benefits will further synthesis of information into final positions to be docu-contribute to streamlining the staff's LA review.

Table 2. Pre IA Reviews and Suppor1ing Activities Applicable tolipes ofIA Reviews 'I) pes ofIA Review Applicable Pre-IA Review and Supporting Activities 'I}pe 1 Annotated Outline reviews 1ppe 2 Annotated Outline reviews Type 3 Annotated Outline reviews 1bpical report reviews Major design report reviews Annual performance assessment reviews SCP review (completed) SCP progress report reviews QA plan reviews QA audits, observation audits, and surveillances Study Plan reviews Meetings and technical exchar.ges 1ppe 4 Detailed study plan concerns Detailed technical report reviews Data reviews Site / lab visits QA audits, observation audits, and surveillances Meetings and technical exchanges Iterative performance assessment and technical analyses using availabic methods Lower priority research lype 5 Same as 'Ippe 4 activities Iterative performance assessments, and technical analyses using staff developed methods Iligher priority research 3. Conduct focused GA reviews and QA audits QA program in place before the activity is started, and that DOE will acceptably implement its QA program This strategy consists of reviewing DOE's OA plans, au-throughout the pre-LA phase. diting DOE's program, observing DOE's audits, and con-ducting surveillances. These reviews and audits are for determining the acceptability of DOE's QA plans and Audits or surveillances will not be performed for DOE's obtaining confidence t hat the overall O A program is being complete program: instead parts of DOE's program will implemented by DOE in an acceptable manner. In addi-he the focus of staff attention.1b some extent, audits and tion, the observation audits and surveillances give the surveillances will be focused in the same areas as the staff an opportunity to judge the effectiveness of DOE's technical reviews, so there is technical involvement with audits of its own QA program. The staff's approach of QA audits, and for efficient use of staff resources. In accepting DOE QA programs requires DOE to first pass a'JJition, reviews of selected administrative procedures judgment on the acceptability of any QA program it wants and their implementation will be conducted in such areas the staff to accept. In this way, the staffis ensuring that as sampic management, data base access and control, and DOE retains responsibility for ensuring that the reposito-document control. Finally, this strategy includes evaluat-ry QA program is being conducted in an acceptable man-ing concerns documented from technical reviews, to de-ner. All of these activities are aimed at ensurmg that for termine if they are indicative of concerns with the overall safety / waste isolation activities. DOE has an acceptable Q A program. NUR EG-1495 12

= This strategy has numerous benefits. First, based on y ears compliance with 10 CFR Part 60, but will be to review the of reviews and audits, the staff will have confidence that sufficiency of information necessary for a complete and DOE's compliance demonstrations in the LA have been acceptable LA. These reviews will be used in preparing prepared under acceptable QA programs. Second, confi-NRC's preliminary site characterization sufficiency com-dence in the acceptability of DOE's QA program comple-ments required by NWPA. ments the audit approach of both the pre-LA technical reviews and the LA compliance reviews. Finally, accept-6. Support reviews by documenting concerns as open items ing DOE's QA programs before work begins will avoid and tracking DOE resolution of these open items. using unnecessary costs or schedule delays that would result if a compulcr data base. testing had to be repeated to replace data that were unac-ceptable because of QA problems. This strategy involves documenting, in letters to DOE, the concerns identified by technical and QA reviews and 4. Condua: reviews of DOE's issue resolution strategy and QA audits. These concerns are also referred to as open performance allocation process, items.10 CFR 60.18 provides the staff with the respmsi-bility to identify both objections and comments to DOE, throughout the pre 1A phase. 'Ib implement this provi-DOE's issue resolution strategy and performance alloca-on, the staff has defmed four kinds of open items related tion process described in DOE's SCP is intended to be a to concerns with DOE's program: start work objections, decision aiding process by which DOE assigns perform-LA submittal objections, comments, and questions (see ance goals and desired levels of confidence in those goals Appendix C for the definitions of these concerns). In its to each of the repositorv system, subsystem barriers, and review of the SCP, the staff documented open items in its their components, and ' eventually determines if enough SCA (i.e., objections to DOE starting specific site charac-irformation has been collected and adequately assessed terization activities, comments, and questions).Through-to achieve those goals at the desired level of confidence. out tk pmLA phase, the staff will continue to identify nis process was agreed upon by the staff and DOE as the open items, comparable to those m the SCA, as it reviews principle mechanism to make sure DOE exercises its re-other DOE documents, such as semi-annual SCp prog-sponsibility for site characterization and demonstrating ress reports, study plans, technical reports, topical reperts compliance with 10 CFR Part 60, in the IA. In addition to and LAAOs. AU open items are important for DOE to agreeing with DOE's issue resolution strategy and review-redehwever, the staff m,ght also consider some com-i ing it in the SCP, the staff will review any revisions to the ments and quesdons to be entical to the staff's LA review, strategy, together with the implementation of the strategy because lack of acceptable DOE resolution wouldprevent throughout the pre-LA phase. Such reviews will help en-the staff from conducting a meaningful review, or the sure that DOE's LA is based on a sound and well-Comm,ission from making a decision regarding construc-documented technical decision-aiding process. The re-tion authorization, withm the 3-year statutory time peri-suits of the focused technical reviews in the pre-LA

d. For this reason, the staff considers this type of concern Review Strategy 3 will help determine how well DOE's t be an oNecin to IA submittal. Concerns that would process is being implemented.

need a long time to resolve, such as new or additional testing or development of new or revised analytical meth-1 C,onduct reviews of DOE AO for the LA. ods, are examples of this type of objection. DOE has started its iterative development of the AO for After the staff has documented a concern with DOE's the IA, which will evolve into a draft of a potential IA program as an open item, it is DOE's responsibility to resolve cach open item.The staff will track DOE's resolu-(Roberts,1992). It will be revised throughout the pre-LA tion of these open items as part of the focused technical phase based on new information and NRC staff guidance. and QA reviews discussed above. When DOE has re-The AO will provide the staff with DOE's understanding solved an open item in a manner acceptable to the staff, and interpretation of the applicable regulatory require-the staff will document its agreement with DOE that the ments, the implementation of these requirements, and open item has been resolved. New information may re-understanding of the format and content of the LA, as quire further consideration of an open item, causing it to crpressed in the staff's regulatory guide " Format and be rcopened. it is important to emphasize that. consistent Content of the License Application for the High-level with 10 CFR 60.18, such resolution of open items is only at Waste Repository (FCRG) (NRC,1991). Therefore, the the staff level, and therefore, can be raised in licensing. staff's review of DOE's AO will be an important way to The staff expects that DOE will make every effort to give DOE timely guidance regarding how DOE is inter-resolve all the staff's concerns, particularly those identi-preting the applicable regulatory requirements and re-fied as objections to LA submittal. However, it is possible garding w hat information is needed to prepare a complete that reaching an agreeable resolution for some objections and acceptable LA. Although the staff's AO reviews will could be difficult. Theref ore, objections to IA submittal use the draft IARP, the reviews will not be to determine will be considered by the staff in preparing NRC's 13 NUREG-1495

preliminary site characterization sufficiency comments, phone recording. The State of Nevada, affected Indian which are required by Section 114(a)(3)of the NWPA, and Tribes, and affected units oflocal government representa-which will be submitted as part of the President's Site tives are invited to participate, and other parties can at-Recommendation to Congress. Furthermore, as part of tend as observers. Each interaction is documented in min-the acceptance review of the LA and before a decision on utes signed by the staff and DOE and made available to docketing the LA, the staff will evaluate the effect of any interested parties and NRC's Public Document Room. In unresolved objections to LA submittal, both individually addition, N RC's onsite licensing representative office will and in combination with others, on the staff's ability to continue to provide prompt information exchange and conduct a meaningful review and make a decision regard. consultation with DOE. ing construction authorization within the 3-year statutory time period. This strategy also includes staff consideration of com-ments by other parties about DOE's program, as well as The staff will track these open items using a computerized considering comments that other parties might have on data base referred to as the Open Item Tracking System the staff's concerns with DOE's program. If appropriate, (OITS). Included in this data base for each open item will the staff might initiate a review to follow up on such be a statement of the item, basis for the concern, resolu-comments. tien history, pertinent references, and cross references to applicabic 10 CFR Part 60 requirements and individual This strategy contributes to implementing requirements review plans in the LARP.The status of open items will be of NWPA and 10 CFR Part 60, agreements between NRC formally reported on in two ways. First, an annual summa-and DOE, and agency policies and procedures for open-ry report will be prepared, of the status of all open items, ness.The benefit of this strategy is to facilitate resolution and included in the semi-annual progress report to the of concerns, improve communications, and help ensure Commission, for the last reporting period for each fiscal that the staff is aware of, and considers pertinent views of year. This report will also be given to DOE and other other parties, while conducting its reviews. interested parties. Second, a status report will also be included in the staff's comments to DOE on the SCP progress reports. 4 STRATEGIES FOR DEVELOPING Tile LA AND PRE-LA REVIEW This strategy implements the provision of 10 CFR 60.18 CAPABILITY for identifying comments and objections, and thereby standardizes how these review concerns are documented, .me follow.mg strategies will be used, during the pre LA tracked, and resolved. Furthermore, it is consistent with the staff's established review practice, as expressed in the phase, to develop bot h the LA and pre LA review capabil-RS and updates, SCP review plan (NRC), and draft sty: FCRG. The staff expects that this strategy will improve the efficiency of documenting the staff's pre-LA reviews 1. Develop the LARP to guide the staff's LA review, and improve communication of staff concerns to DOE. It Develop the LARP carly and revise it iteratively, alsoisintended to focus the attention of both the staff and based on new information and implementation expc. DOE on resolving concerns before LA submittal. Finally, rience; this strategy will help streamline the staff's LA review by making availabic all the concerns, how DOE resolved 2. Use the principles of systems engineering to develop them, how the staff reviewed and closed them, and the LARP; associated references, on a computerized data base, for rapid search and retrieval by the staff. 3. Use existing pre-LA review plans and develop addi-tional review plans, to use in conjunction with the 7. Support reviews with open interactions with DOE and LARY, to guide the pre-LA reviews; otherpanies, together with considering concerns ofother parties. 4. Develop a performance assessment and other tech-nical analysis capability early and revise it iteratively, This strategy includes supporting the technical and QA Dased on new information and implementation expe-reviews with a variety of open interactions with DOE, rience; such as technical meetings, management meetings, tech-nical exchanges, and site visits. These interactions are for 5. Conduct research to develop data, understandmg, exchanging information, discussing resolution of open and methods necessary to support the reviews. items, and generally improving communications and un. derstanding among all parties. The schedules for these A description and rationale for each strategy are given interactions are made available by written notice and tele-below. NU REG-1495 14

L Develop the LARP to guide she staf)'s LA review Devel-LA review and enhance pre-LA guidance and consulta-op the LARP carly and reviseit iteratively, based on new tion with DOE. information and implementation c2perience. \\ Using ihe SRA for developing the LARP also involves j 'Ihc LARP will be developed carly in t he pre-LA phase, to developing the content of each review plan, following ~ focus in a timely manner on what is needed in the LA to procedures prepared and approved for use, under the 1 improve the basis for pre-LA reviews and resulting guid-Center for Nuclear Waste Regulator, Analyses' ance to DOE. Early development is also needed to allow (CNWRA's) QA program, to apply criteria in Appendix 3 time to prepare and refine the LARP and supporting to select the type of IA review that is appropriate for each analyses and research investigations. The staff recognizes regulatory requirement of 10 CFR Part 60 that is related the exploratory and evolving nature of the repository pro-to the LA. Consistent with LA Review Strategies 4 and 5, 1 gram, as well as the need for flexibility under these condi-described in Section 3.2, criteria are used to select five tions. Because of this, the staff expects to develop the standard types of reviews, which involve different ievels of LARP iteratively. The staff's initial judgments and prod-detail and different review methods (see Appendix B). j ucts will be reevaluated annually, and updated as needed, The type of review is used to develop the specific review based on pre-LA review experience. input from DOE and strategy that will be included in each individual review other parties, new information, new insights, er the avail-plan dealing with the applicable regulatory requirements. ability of new analytical methods. For example, the staff's The review strategy gives the general scope, approach, initial judgments in identifying technical uncertainties and type of review that will help the staff streamline its that pose a high risk of non-compliance will eventually work and optimize its resources during the LA review. It need to be evaluated more quantitatively by using sensi-does this by focusing the staff work on those technical tivity analysis methods developed by the IPA activity (dis-uncertainties most important to performance (i.e., key cussed below). Any changes that result may lead to technical uncertainties)and where more detailed reviews changes in the review strategies or review methods. and rigorous methods of review will be conducted. In addition, the review strategy will help identify what re-search, model development, and preLA reviews are need-The draft LARP will be developed, starting in FY92 and ending in FY01 with a revision each year, to incorporate ed to prepare for the staff's LA review. new and revised sections as they are prepared by the staff. Further development of the LARP m.volves using the SRA to develop, within the bounds of the review strategy 2. U e theprinciples ofsystems engineering to develop the already developed, the review procedures, acceptance cri-teria, implementation, and staff example evaluation find-ings.This information gives more detailed guidance to the The LARP will be developed using the Systematic Regu-staff for determining the acceptability of DOE's LA and latory Analysis (SRA). In general, the SRA is a formal, making evaluation findings for each regulatory require-systematic, and documented process specifically devel-ment of 10 CFR Ibrt 60. oped to apply the principles of systems engineering to the needs of the staff's IILWM program. SRA is a process Finally, the SRA process and implementing procedures that helps focus, in a consistent and documented manner, also require that rationales and supporting references be the staff's technical and programmatic judgments. This documented for the review strategies, review procedures, process is particularly well suited for dealing with some of and acceptance criteria. All of this information is entered the challenging aspects of the repository licensing into a computer data base, (the Repository Program Data-program (e.g., it is complex, first-of-a kind, multi-base) which will facilitate the staff's storhge, search, and disciplinary, and of long duration). The SRA will help retrieval of background information relevant to the staff's identify, prioritize, and integrate the LA review. As a LA review. result, the staff will have greater confidence that all the necessary reviews are done, that the reviews are done in a 3. Use existmgpre-LA reviewplans and develop additional consistent and integrated manner, that the reviews are review plans to use, in conjunction with the LARl! to done as efficiently as possible, and that the review plans guide the pre-LA reviews. and supporting rationales are sufficiently documented to preserve a record for future staff reference. Pre-LA reviews of DOE's plans will be guided by already existing review plans and procedures for the SCP Progress Specifically, using the SRA first involves developing a Reports, study plans, technical reports, and QA program, common organizational structure between the individual These existing review plans will be r evised, where needed review plans making up the l_ARP and the grouping of to, implement the pre-LA review strategies. Additional 10 CFR Ibri 60 requirements into the system / subsystem review plans will be developed, as needed, for reviews of structure of the FCRG. A common structure among the other documents, such as topical reports. Acceptance cri-LARP, FCRG, and DOE's LA should facilitate the staff's teria in the LARP will be used, where applicable, to assist 15 NUREG-1495

~-= in pre-LA reviews,in particular the reviews of DOE's AO IPA also provides a tool for technical integration, because and topical reports, it provides the structure for examining couplings between phenomena that might not be adequately evaluated, with-4. Derclop a performance assessment and other technical in the limits of a specific technical discipline. In addition,- analysis capability early and reriac it iteratively, based the multi-disciplinary involvement with data inputs, as-on new information and imp /cmentation caperience, sumptions, and code development more clearly defines activities and interfaces of the many disciplines involved, 'Ib support the detailed LA and pre-LA reviews, the staff In this way, IPA also contributes to programmatic integra. l'0"' will develop a performance assessment capability, IPA, as well as other technical analysis methods, such as thermo-mechanical modeling and tectonic modeling. IPA and other technical analyses complement the SRA process used to develop the LARP, by feeding the results of integmted technical analyses back into the SRA pro-IPA will en hance t he ' taff's capability to perform a n ci.fec-cess. As mentioned previously, k nowledge gained through tive review of DOE's pericrirance assessment, which wdl IPA will be used to reevaluate the significance of technical be the prmeipal way

  • hat DOE wdl demonstrate com-uncertainties important to performance and thereby pro-

- pliance with the performance objectives of 10 CFR Part 60 vide a quantitative basis for determining the need to re-in the LA. IPA is an iterative process of technical analyses v se these key technical uncertainties and associated re-primarily using predictive models and computer codes to view strategies. Sensitivity analysis will be conducted *o obtain quantitative estimates of repository performance. evaluate all key technical uncertaintics identified in the More specifically, IPA consists of developing system de-SRA, to confirm the staff's initial judgment in identifymg scriptions and supporting databases, together with con-these key technical uncertaintics. As the SRA process is ducting scenario analyscs, consequence analyses, per-used to develop the LARP, it will help to ensure that IPA formance. measure calculations, sensitivity and activities are appropriately focused to contribute in a log-uncertainty analyses, and comparisons to the perform ^ ical fashion to the LARP and LA review. ance objectives of 10 CFR Part 60. These analyses are repeated as new data and increased understanding from Appendix D gives the Performance Assessment Strategy, NRC-supported or ofher research becomes available. w hich describes in more detail the development phases of . Through this iterative process, progressively refined capa-the IPA. bility and resulting assessments of repository perform-ance as it relates to the performance objectives in 10 CFR 1 Conduct research to develop data, understandine and Part 60, may be obtained. methods needed to support reviews. Development of computer models and codes will be an 'Ib support the review strategics and methods in the ongoing activity, with models and codes continuously be-LARP, the results of the staff's research will be used. In ing refined as improved information is obtained during addition, results of research will be useful in conducting site characterization. Moreover, development of models pre LA reviews. For example, research can develop inde-and codes is only a part of IPA. Of equal or greater impor-pendent understanding of basic processes and develop tance is development of the staff expertise, and familiarity licensing tools such as models and codes, data, and other with the Yucca Mountain site, sufficient to allow identifi-information that will contribute to the technical basis cation of the key phenomena important for repository necessary for the staff to judge the adequacy of the LA. In performance; formulation of conceptual models of the addition, research can also provide limited confirmatory phenomena and their effects on repository performance; information. For results of research to be available for the and completion of sensitivity and uncertainty analyses, to staff's 1.A review, research must be conducted in a timely determine the importance of individual parameters, on manner, throughout the pre-LA phase. As the LARP is the overall repository system. Such information will be developed using the SRA, and as IPA is conducted, the used to support the staff judgments regarding the signifi. staff will also use this information to identify and priori-cimce of key technical uncertainties identified durmg tire needed research. As previously mentioned, the re-LARP development using the SRA process. Further-view strategies in the LARP will allow the staff to identify more, it is important to emphasize the iterative nature of areas that are judged most important to compliance (i.c, IPA. Each iteration will provide the information needed key technical uncertainties). For some of these key techni-to provide comments to DOE, regarding priorities for site cal uncertainties, detailed safety reviews of the LA will characterization to ensure that necessary site information rely on use of research results. Such identification will is collected, to refine the models and codes describing hc!p the staff revise its research user needs in a.more repository performance. The sensitivity and uncertainty systematic and comprehensive way that is more directly analyses of IPA, together with the LARP, are expected to linked to as LA review needs and those areas that are provide much of the technical basis for reviewing DOE's most important to repository perfortr.ance and determi-progress in characterizing the Yucca Mountain site. nations of compliance. In addition to importance to per-NUREG-1495 16

formance and LA review, other factors are also consid-range strategic development plans, the periodic develo, cred: programmatie needs, timing, and resource ment plans, and the llLWM Operating Plan. The initia, constraints. The research needs identified as a result of long-range, strategic development plans and periodic the SRA/ IPA review strategy developrnent will be com-plans will be prepared in FY94. For RES activities, more pared to the ongoing research program, and necessary detailed implementation will be accomplished through adjustments will be made, As research work progresses, the Research Program Plan. the staff will evaluate the results, as part of the SRA process, to determine if additional research is needed to Finally, the ORS will be evaluated annually and updated satisfy review needs. as needed. l 5 IMPLEMENTING AND 6 REFERENCES UPDATING TIIE OVERALL Nuclear Regulatory Commission, " Regulatory Strategy REVIEW STRATEGY and Schedules for the Iligh-Level Waste Repository Pro-gram," Commission Paper SECY-88-285, October 5, Tb impicment the ORS, the staff will use the objectives 1988. and strategies described above, to guide its development, each year of the Five-Year Plan and Iludget. In these Nuclear Regulatory Commission, "First Update of th( broad agency planning decuments, general activities, Regulatory Strategy and Schedules for the fligh-Leve schedules, and resource needs for 5 and 3-year planning Waste Repository Program," Commission Pape periods, respectively, will be developed for conducting SECY-90-207, June 7,1090. reviews and developing review capability. For IILWM activities needed for developing LARit IPA, and other Nuclear Regulatory Commission, " Format and Conten technical analyses, more detailed implementation will be for the License Application for the High-Level Wasti accomplished by developing both long-range, strategic Repository," Office of Nuclear Regulatory Research development plans, and periodic development plans for Draft Regulatory Guide, DG-3003 November 1990. cach of these activitics. The long-range, strategic devel-opment plans will give general plans and schedules for the Nuclear Regulatory Commission,"Second Update of tht full capability development period, whereas the periodic Regulatory Strategy and Schedules for the fligh-Leve; plans will give additional detailed guidance for a single Waste Repository Program," Commission Paper fiscal year for LARP and about 18 months for IPA and SECY-91-225. July 29,1991. other technical analyses. Where possible, development schedules will be chosen to support pre-LA reviews of Roberts, J. P., U.S. Department of Energy, letter to J. J. DOE site characterization program activities. The activi-I lolonich, Nuclear Regulatory Commission, J uly 20,1992. ties and schedules,in the periodic plan, along with pre LA review activities, will be implemented and tracked, using U.S. Department of Energy," Site Characterization Plan, the staff's iILWM Operating Plan. Figure 5 illustratesIhe Yucca Mountain Site, Nevada Research and Develop-relationship described above between ORS, the long-ment Area. Nevada " DOE /RW-Ol99, December 1988. l 17 NUREG-1495

OVERALL REVIEW STRATEGY Strategies for Developing Review Capabilities l J f 1 f LONG-RANGE, STRATEGIC LONG-RANGE, STRATEGIC DEVELOPMENT PLAN FOR DEVELOPMENT PLAN FOR ITERATIVE PERFORMANCE THE LICENSE APPLICATION ASSESSMENT AND REVIEW PLAN TECHNICAL ANALYSES 1f 1 f PERIODIC DEVELOPMENT PLAN FOR ITERATIVE ANNUAL DEVELOPMENT PERFORMANCE PLAN FOR THE LICENSE ASSESSMENT AND APPLICATION REVIEW PLAN TECHNICAL ANALYSES 1 1 f 1 f HLWM OPERATING PLAN Figure 5 Plans for Guiding the Development of LA Reviews Capability During the Pre-LA Phase. NUREG-1495 18 e

= APPENDIX A

SUMMARY

OF STATUTORY AND REGULATORY REQUIREMENTS AND POLICY APPLICA11LE TO TIIE OVERALL REVIEW STRATEGY 1 STATUTORY REQUIREMENTS repository involved, within the time periods specified in the NWPA. This schedule must include a descriphon of objectives and a sequence of deadlines for all Federal 'the Nuc! car Regulatory Commission's licensing and re-agencies required to take action, including an identifica-lated regulatory authority is defined by the Atomic Energy tion of the activities in which delay in the start, or comple-Act of 1954, as amendedflhis authority is madc applicable tion, of such activities will cause a delay in beginning to the U.S. Department of Energy (DOE), as successor to repository operation.This provision requires that a specif-the Energy Research and Development Administration, ic report be provided by any Federal agency, including under Section 202 of the Energy Reorganization Act of NRC,if the agency determines it cannot comply,or fails to 1974. Congress further defined NRC's role asit relates to comply, with any deadline in the PDS. This report, sub-the disposal of high-level radioactive waste in geologic mitted to DOE and to the Congress, would include the repositories in the Nuclear Waste Policy Act of 1982 reason w hy the agency could not reach an agreement with (NWPA) and NWPA, as amended in 1987. The require-the DOE. the estimated time for completion of the activ-ments of NWPA, as amended relevant to the Overall ity(ics), and the associated effect on its other deadlines in Review Strategy (ORS) are summariicd below. the PDS and any reccmmendation or actions to mitigate the delay involved. 1.1 Promulgation of Regulations The PDS (Revision 1). issued in J une 1991, identifies many future NRC actions, of which the actions below are rele-The Commission has promulgated regulations dealing with all aspects of the disposal of highlevel radioactise vant to the ORS and proposed by DOE (and agreed to by waste in geologic repositories. 'lhese regulations are con-NRC) to be subject to the reporting requirements of Sec-tion ll4(c) of NWPA, described above. Those identified tained principally in 10 CFR Part 60, but also include provisions in 10 CFR Part 2 relating to procedural aspects by NWPA are NWPA required actions. of t he license application review process, and provisions in Comment on Sufficiency of Site Characterization e 10 CFR Part 51, pertaining to implementation of the Na' Analysis (NWPA) tional Environmental Pohey Act (NEl%). The regula-tions, which conform to the requirements of Section Complete Acceptance Review of License Applica-e 121(b) of NWPA, address certain pre-license apphcation tion (LA) (LA) reviews, as well as the consiJeration of LAs. Report Status to Congress of LA Review and Con-1.2 Review of DOE's Mission Plan struction Authorization Decision (NWPA) COQP CIC l^ RCVIC* I Consistent with Section.' ;(b)(1)of NWPA, the Commis-sion will review and comment on any amendments to e Issue Construction Authonzation (NWPA) DOE s Mission Plan. This plan provides an informational basis sufficient to permit informed decisions to be made in The schedules given in the PDS for the above NRC ac-carrying out the reposnory program and the research, tions necessitate that the ORS identify and update sched-development, and demonstration programs under the ules for these required actions and major milestones sup-NWi".. Ihis provision is important to the ORS because it porting these actions. More importantly, the ORS itself requires the staff to consider and comment on f undamen~ has been developed to help ensure meeting the above tal, broad-scale programmatic factors that contribute to required actions. successful DOE program operation. 1.4 Review and Comment on Plans for 1.3 Inputs to DOE's Project Decision DOE's Site Characterization Program Schedule (PDS) Consistent with Section ll3(b)(1)(A) of NWPA, before Consistent with Section ll4(c)of NWPA, DOE must pre-proceeding to sink shafts at any c:mdidate sites, DOE pare and update, as appro;,nate, in cooperation with all must suhrnit a general plan for site characterization (i.e., afIceted Federal agencies, includmg NRC. a PDS that Site Characterization Plan (SCP)) for such c:mdidate site, portrays the optimum way to attain the operation of the to the Commission, for its review and comment. A-1 NUREG-1495

Consistent with Section ll3(cX2XA). DOE may not use application, unless the Commission extends such time any radioactive material at the candidate site, during site period by not more than 12 months as specified in NWPA. characterization, unless the Commission concurs that such use is necessary to provide data for the preparation of This provision is the most important one to the ORS, the required environmental reports and an application for because it sets a very ambitious statutory schedule for a construction authorization for a repository, licensing.This statutory time period, in turn,is the reason for certain review and review capability development strategies being taken, to help meet the 3-year licensing 1.5 Preliminary Comment on Suf&ie: cv of period. l DOE's At-Depth Site ChmarizaLon Propasal 1.9 Focus on the Yucca Mountain Site Analysis and Waste Fon t Consistent with Section ll4(aXIXE) m ' A E pahmL Pursuant to NWPA, as amended, DOE is directed to focus nary comments will be prepared by the Coi. m en. ;or" its site characterization activities only on the Yucca cerning the extent to which the at-depth site 6 Mountain site. This, in turn, has focused NRC's ORS also tion analysis and the waste form proposal for sud.. te on the Yucca Mountain site. seem to be sufficient for inclusion in any application DOE submits for licensing a site as a repository. DOE will 2 APPLICABLE REGULATORY publish these comments m its Site Recommendation Re-REQUIREMENTS AND GUIDANCE port to the President. Items 4 and 5, together, give a statutory basis for conduct-2.1 License Application Review ing pre-LA reviews of the plans and results of DOE's program supporting the development of the LA, along Of particular importance to the staff's LA review is 10 with those activities necessary to prepare for these re-CFR 60.31, This section describes the three determina-views. tions that the Commission will make in considering whether to authorize construction. These determinations are: (1) safety, (2) common defense and security, and 1.6 State and Tribal Part..icipat. ion (3) environmental.The staff's LA review is related to the Commission's safety and common defense and security Consistent with Section ll7(a)(1)of NWPA, the Commis-sion must provide to the Governor and legislature of a be the primary findings documented m, each of these w determinations; the staff's findmgs for its safety evalua-potential repository State, and to the governing body of tion upon (SER) for consideration by the Commission. any affected Indian tribe, timely and complete informa-stats n,ew of DOE's Envimamental Impact tion regarding determinations or plans made with respect Statement would be documented elsewhere and, there-to site characterization, siting, development, and decom-f re, not in the SER.) missioning of such repository. 10 CFR 60.31 also lists six considerations that the Com. mission will use in making its safety determination for a 1.7 Status Report on License Application c nstruction enthorization decision. Similarly, the staff's Review to Congress LA review will make secondary evaluation findings for Consistent with Section ll4(c), not later than 1 year after each of these six considerations, to support its primary the date on which an application for a construction autho. safety evaluation finding.'Ihese six considerationsinclude rization is submitted, and annually thereafter until the compliance with specific 10 CFR Part 60 requirements date on which the authorization is granted, the Commis. given in the technical criteria of Subpart E, the quality sion shall submit a report, to Congress, describing the assurance requirements of Subpart G, the personnel proceedings undertaken through the date of the report, training criteria of Subpart II, and the emergency plan with regard to the application. criteria of Subpart 1.Two other considerations are wheth-er DOE has described the proposed geologic repository and planned repository operations.10 CFR 60.21 further 1.8 Licensing Decision for Construction specifies these and other required descriptions, together Authorization with the assessments to be included in the L.A. Consistent with Section ll4(d), the Commissian shall Procedural requirements for repository licensing are giv-consider an application for a construction authori7ation en in 10 CFR Part 2. A few of these requirements are of for a repository and shall issue a final decision approving specific importance to the LA review. First,10 CFR or disapproving the issuance of a construction authoriza-2.101(f) requires the staff to determine if the DOE's LA is tion, within 3 years after the date of submission of the complete and acceptable for docketing. This determina-NUREG-1495 A-2 m

tion is based on the results of wLat is referred to as an and observe in-situ testing activities, excavations, and bor-acceptance review (see Section 3.2 for further discussion). ings. Sec(md,10 CFR 2.102 indicates that the staff may request additional information from the applicant and can confer In addition to the procedural requirements important to informally with any party during its review of the LA. pre-LA reviews, the technical requirements of 10 CFR Finally, although not specified in 10 CFR Part 2. itself, in Ibrt 60 that DOE must comply with in its LA and that the the statement of ccmsiderations supporting the rule on the staff will review and make findings for in its SER, will also Submission and Management of Records and Documents be the focus of the staff's pre-LA reviews. Related to the Licensing of a Geologic Repository for Ihe Disposal of High-Level Waste, the Commission gave a Finally, Draft Regulatory Guide DG-3003: " Format and model schedule for the licensing proceedings for general Content for the License Application for the High-Level guidance in meeting the statutory 3 year time period for Waste Repository" (FCRG) provides a format and con-the Cornmission to make its construction authorization tent for the LA that would be acceptable to the staff.This l decision.This schedule includes 18 months for the staff to FCRG also is the organizational structure for the staff's review the LA and prepare its SER. License Application Review Plan (LARP). i ) 3 APPLICABLE EXISTING NRC POLICY 2.2 Pre-License Application Review 3,1 Five-Year Plan In addition to requirements for the LA review,10 CFR Ibrt 60 also gives procedural requirements for DOE im. A primary source of Commission policy guidance is the portant to the staff's pre-LA reviews. In particular,10 Five-Year Plan. The Five-Year Plan objectives most sig-CFR 60.15 requires DOE to conduct a program of site mficant to the staff's reviews are: characterization consistent with a number of specific re-quirements for testing, limiting adverse effects of testing 1. Statutory requirements will be met; on long-term repository per!armance, and coordinating testing with repository design and construction. In addi-2. In the absence of unresolved safety issues, staff re-tion,10 CFR 60.16 requires DOE to prepare a SCP consis-views will not hold up DOE's program; tent with the content requirements given in 10 CFR 60.17. DOE is also required, by 10 CFR 60.18(g), to provide 3. Continue pre-LA reviews, based on DOE's sched-semiannual progress reports to the Commission, regard-ule, to ensure timely regulatory guidance on techni-ing site characterization activities, as wc!! as repository cal issues, and timely identification and resolution of and waste package design.The contents for t hese progress issues; reports are specified in 10 CFR 60.18. 4. Develop LA review capability, including licensing criteria and evaluation methods: Procedural requirements for the NRC staff's review of DOE's site characterization activities also are included in 5. 'lhe NRC will contin ue an active program ofinterac-10 LRF 60.18. In summary,10 CFR 60.18 requires the tion and cooperation with the State of Nevada, af-Nuclear Material Safety and Safeguards (NMSS) Director fccted counties and Indian tribes, and interest (and supporting staff) to review DOE's SCP and prepare a groups; Site Characterization Analysis (SCA); this review has been completed. In addition, the Director may comment 6. Guidance for reso'ving licensing issues (e.g.,includ-any tirne in writing to DOE on any aspect of DOE's site ing the LARP) will be developed by FY 1998; this characterization program. Objections or recommenda-work will be prioritized so that those most important tions can be included. If appropriate, the Director's com-to DOE site characterization and NRC meeting the ments should include a determination regarding whether 3-year licensing review are given the highest sched-the Commission concurs that DOE's proposed use of uling priority; radioactive material is necessary for site characterization. '1h support any of its reviews, the staff may invite and 7. Reviews and development of review capability will consider the views of other parties. In addition, all the be coordinated with NMSS, Office of Nuclear Regu-Director's comments will be made avaithic in NRC's latory Research (RES), and the Office of General Public Document Room and will be sent o the appropri-Counsel (OGC); and ate State, Indian Tribn and affected units of hical govern-ment. The Director shall invite publ3 comment on any 8. Formalize procedures for documenting agreements comments the Director makes to DOE. Finally, the NRC between the NRC and DOE staffs, on the resolution staff is permitted to visit site characterization h> cations, of technical issues, in advance of the LA review. A-3 NUREG-1495

d General activity descriptions in the Five-Year Plan also FCRG.The RS also mentions that the staff would use an give additional guidance applicable to pre-LA reviews. In Open Item Tracking System to track resolution of objec-these descriptions, it is recognized that detailed study tions and other concerns identified in the staff's pre-LA plan, document reviews, and quality assurance (QA) au-reviews. The first and second updates to the RS also dits will be limited to a sample in selected areas. For express the staff's intent to identify key technical uncer-example, only 20 percent of DOE's 106 study plans can be tainties, which are those technical uncertainties that are reviewed in detail, given the present resources. It is also most significant to performance. These key technical un-recognized that the LARP, w hich will be developed during certainties will be useful in prioritizing those technical the pre-LA phase, will assist the staff in conducting its areas where the staff would develop its modeling capabili-pre-LA review'. Finally, the Five-Year Plan recognizes ty, conduct research, and conduct detailed pre-LA re-that staff reviews will be supported by independent per-views. Finally, the updates to the RS explain that the staff formance assessments and other investigations, such as would be using the Systematic Regulatory Analysis (SRA) those conducted by RES. to develop a well-integrated review capability in the l LARP. 3.2 Regulatory Strategy 3.3 SCP Review Plan The staff's Regulatory Strategy (RS)(SECY-88-285) and updates (SECY-90-207 and SECY-91-225) establish a The SCP Review Plan also establishes review policy im-i number of staff policies important to the ORS. Strategies portant to identifying and documenting concerns with for identifying and resolving technical uncertainties (as DOE's program in a consistent manner, following three well as regulatory and institutional uneenainties, which kinds of defined concerns. The three concerns defined are not the focus of Ihe ORS) arc discussed. In particular, are objections to starting work, comments, and questions. pre.LA reviews are one important way the staff will use to The staff's intent to establish an Open Item Tracking identify technic:d uncertainties. In addition, the staff con _ System is also discussed. siders that it is DOE's responsibility to reduce technictd uncertainties through site characterization activities and 3.4 NRC-DOE Procedural Agreements pre-LA consultations with NRC, the State of Nevada,and J other parties. Furthermore, it is the staff's responsibility NRC and DOE have two procedural agreements, the to give guidance to DOE on reducing iechnical uncertain-Procedural Agreement and the Site-Specific Agree-ties, before DOE submits its LA. This guidance will be ments, that were recently revised and signed on June 3, primarily in the form of pre-LA review guidance, but for a 1993. These agreements ensure that NRC and DOE few selected cases, staff technical positions will be used. would maintain a flow of information to enable each The RS also establishes the intent of the staff to identify, agency to accomplish its responsibilities under NWPA. during the course of its pre-LA reviews, objections that if Specific provisions are made for open meetings, exchange J not resolved by DOE, would prevent the staff from con-of information, and access to data and samples. The Site-ducting a meaningful review or the Commission from Specific Agreement provides for public notice of sched-making a decision regarding construction authorization ules and agendas for technical and management meet-within the 3-year statutory time period. Such objections, ings, and for NRC and DOE to jointly prepare meeting therefore, might result in the staff not docketing the LA. reports and distribute them to the affected parties, in a The benefits of resolving objections to the staff's LA timely manner. An opportunity is also provided for the review and the IIcaring is discussed. Any unresolved ob-affected parties to include their positions in the meeting jections would also be factored into NRC's Preliminary report.Specialprovisionsareincluded under Appendix 7, Site Characterization Sufficiency Comments required by for interactions among the NRC On-site Representatives NWPA. This policy is furt her described in the staff's draft andI?O E. NUREG-1495 A-4

h i APPENDIX B i SELECTION CRITERIA AND TYPES OF LICENSE APPLICATION (LA) REVIEW i REVIEW 7YPE SELECTION CRITERIA A key technical uncertainty is a technical uncertainty that poses a high risk of non-compliance with a performance Type 1: IA-Related bj ctive f 10 CFR Ibrt 60. It may also be associated w ith reducing a high risk of non-comphance with a perforrn-These are t' c 10 CFR Part 60 requirements for which the ance objective. a U.S. Department of Energy (DOE) must demonstrate For example, a key technical uncertainty exists where compliance in its LA, or which directly affect the content there is a lack of certitude about a methodology that is i or submittal of the LA. These are also the requirements needed to either demonstrate compliance with a perform-that would be addressed in the staff's comph of the LA and for which findings will be made mlmcc review ance objective (e.g., scenario analysis methods are neces-the staff's sary to demonstrate compliance with the containment Safety Evaluation Report. requirement of 40 CFR Ibrt 191). A key technical uncer-tainty also exists where (1) there is a lack of understanding i Excluded from these requirements would be those not about a condition or process, and (2)it is credible that the ~ related to the LA, whether DOE requirements (e.g., Site condition or process exists (or will exist) and could have Characterization Plan requirements in 10 CFR 60.16 and 10 CFR 60.17), Nuclear Regulatory Commissum require-tory perfo'gnificant adverse or favorable effect on either a si rmance. ments (e.g., review of site characterization activities m 10 CFR 60.18 and construction authorization in 10 CFR 60.31(a)), or other procedural requirements (e.g., partici. Type 5: Iligh Potential Risk of Non-pation of State governments and Indian tribes in 10 CFR Compliance and Most Difficult to Ibrt 60, Subpart C). Resolve These 10 CFR lbrt 60 requirements, a subset of the re-Type 2: General Information-Related quirements that pose a high potential risk of non-compliance, pose the highest potential risk because the 'Ihese are the general information requirements con-risk isjudged to be the most difficult to reduce.Therefore, [ tained in 10 CFR 60.21(b), and for which compliance is there might be a high residual risk of non-compliance, necessary to make a safety determination for const ruction because very littic can be done to reduce the risk or com-authorization as defined in 10 CFR 60.31(a). pensate for the risk using, for example, favorable site conditions or engineered features. lype 3: Radiological Safety and Waste-REVIEW 1YPE DESCRIPTION t Isolation Related 3 'Iype 1: Acceptance Review These are 10 CFR Ibrt 60 requirements for which com-pliance is necessary to make a safety determination for This type of review is to determine if the LA is complete construction authorization, as defined in 10 CFR 60.3L and acceptable for docketing and for conducting the com-These include requirements from 10 CFR Ibrt 60 Sub-pliance review in an effective and timely manner. This is parts E G II, I, and 10 CFR 60.2)(c). not a review to determine adequacy. Type 4: Iligh Potential Risk of Non-Compliance Reriers Compliance with a Performance 'lype 2: General Information Review Objective of 10 CFR Part 60 This type of review is to determine the adequacy of coa). These 10 CFR Ibrt 60 requircments are the subset of all pliance with the general information requirements of I the radiological health-and-s fety or waste isolation-10 CFR Ibrt 60. related requirements for which there is a high potential j risk of non-compliance with one or more of the perform. Type 3: Safety Review ance objectives in 10 CFR 60.111,112, or 113. The high potential risk of non-compliance comes from the exis-This type of review is to determine the adequacy of the tence of key technical uncertainties. compliance demonstrations and associated system B-1 NUREG-1495 i J

I descriptions, which are associated with the Safety Analy-Independent investigations, including research, can also sis Report of the LA (i.e., related to radiological health support Type 4 reviews if justified; however, these investi- ) and safety or waste isolation). 'lhe focus of this review is gations would be.ower priority than those supporting a primarily on the I A itself, although some references 'l}pe 5 review. might also be reviewed if they contain essential com-pliance demonstration information. Generally, however, It.s important to note that a review type might eventually the detailed information supporting the compliance dem-be changed to a lower or higher type, should newinf orma-l onstration in the LA references will not be the focus of tion or lack of information either reduce the key technical this type of review. The safety review might also be sup-undertainty causing the risk of non-compliance, or lead to ] ported by simple verifications, using handtvoks, standard identifying a new key technical uncertainty. formula, or "back-of-the-envelope" calculations. Ilowev-f er, detailed verifications using complex numerical model-ing should not be used. A1}pe 3 review might eventually Type 5: Detailed Safety Review Supported by i be changed if new information Icads to a key technical Independent Tests, Analyses, or Other uncertainty. Investigations This type of review further supports the Detailed Safety Type 4: Detailed Safety Review Supported by Review with either analyses, tests (laboratory or field), Analyses other investigations conducted by the staff or using meth-ods (e.g., numerical modeling) independently developed 'Ihis review is an expansion or extension of the 1}pe 3 by the staff. Such independent investigations could focus Safety Review in that it is a detailed review of the adequa-on all or a part of a specific key technical uncenainty.This cy of selected detailed information supporting the com-type of review rnight also further supplement the Detailed pliance demonstration in the LA (i.e., " vertical slice" re-Safety Review by verifying some of the LA data ordescrip-views of data, analyses, methods, and technical tions of conditions or processes with data collected by the procedures). Specifically, Detailed Safety Reviews would staff or the understanding of conditions and processes focus on the level (s) of detail appropriate for the assess-obtained by the staff's own investigations (e.g., results of ment of the key technical uncertainty (ies)and how the key the research program). Furthermore, the understanding technical uncertainty should be reduced, compensated of processes may also support the staff's independent for, or remedied by DOE. model development. In addition to analyses and tests, this type of review could, if appropriate, be supported by other The Detailed Safety Review should be supported. if rele-kinds of investigations, such as expen panel solicitations. vant and needed, by analyses conducted by the staff of The specific type of supporting investigations selected specific key technical uncertainties. Such analyses could should be based on what is technically needed to address include use of complex numerical models. Unless justi-the key technical uncertainty (ies). fied, based on the unique nature of the key technical uncertainty, the detailed analyses methods would not be !! should be emphasized, however, that the independent developed by the staff. Instead, the staff would use met h-investigations conducted by the staff are for verification ods, developed by DOE or other parties, that have been purposes and are not a substitute for data or analyses that reviewed and found acceptable by the staff. Although this DOE should be providing to support its compliance dem-type of review requires the staff to obtain and become onstration in the LA. proficient in using a particular method or making minor modifications to the met hod, it does not require, for most Finally, it is important to note that a review type might cases, the exn,,sree msources needed for the staff to eventually be changed to a lower or higher type should develop its own independent nahod. (For special cases, new information or lack of information either reduce the such as where the staff may have concerns with DOE's key technical uncertainty causing the risk of non-data interpretation or method of analysis, the staff could compliance, or lead to identifying a new key technic;d modify DOE's method or use another party's method.) uncertainty. NUREG-1495 11-2

APPENDIX C DEFINITIONS OF STAFF CONCERNS WITII DOE'S PROGRAM Staif-hk Objection: A concern with the U.S. Department long time to resolve, such as new or additional testing or of Energy (DOE) program related to either: developing new or revised analytical methods, are exam-plcs of this type of objection. 1. potential adverse effects on repository performance; Comment: A concern with the DOE program as presented ) 2. potential significant and irreversible /unmitigatable in any DOE document that would result in a significant effects on characterization that would physically pre-adverse effect on licensing if noi resolved, but would not clude obtaining information necessary for licensing; cause irreparable damage if site characterization started before resolution. The DOE program could be modified 3. potential significant disruption to characterization in the future, with some risk to not having the necessary l schedules or sequencing of studies that would sub-information for licensing; the adverse effects would be stantially reduce the ability of DOE to obtain infor-primarily related to the program schedule. 'Iherefore, for mation necessary for licensing; or these concerns, DOE could start work at its own risk before resolving such concerns with NRC. NRC would 4. inadequacies in the quality assurance (QA) program recommend timely resolution of comments. If resolution that must be resolved before work begins. is not achieved in a timely manner, comments might evolve into LA submittal objections. Start-work objections are reserved primarily for concerns with activities that, if started, could cause significant and Gurstion: A major concern with the presentation of the irreparable adverse effects on the site, the site character-DOE program in any DOE document, such as missing ization program, or the eventual usability of the data for information that should be in the documents, level of licensing (programmatic fatal flaws). llecause of this ir-detail, contradictions, and ambiguities that preclude un-reparable nature of objections, the Nuclear Regulatory derstanding a part of DOE's program, thereby preventing Commission would recommend that DOE not start work the staff from being able to comment. NRC would recom-until the objections are satisfactorily resolved. mend DOE clarify such questions. If a question is related to a potential start-work objection, satisfactory resolution Ucense Application (Ist). submittal Objection: A concern should be accomplished before work begins. If a question with the DOE program critical to the staff's LA review is not related to a startwork objection, then DOE could because lack of acceptable DOE resolution would prevent choose to proceed with work at its own risk, and resolve NRC from conducting a meaningful review and making a the questions in future reports. Questions should be re-decision regarding construction authorization within the served for major items; minor inconsistencies should not 3-year statutory time period. Concerns that would need a he included. i C-1 NUREG-1495

APPENDIX D NRC POST-CLOSURE PERFORMANCE ASSESSMENT STRNFEGY FOR A HIGH-LEVEL NUCLEAR WASTE REPOSITORY 1 INTRODUCTION dioactive material in repositories"(Nuclear Waste Policy Act (NWPA), Sec.121) is concerned with the acceptable level of performance of the overall repository system. It In its broadest sense, any qualitative or quantitative esti-specifies three broad quantitative performance objec-mation of the isolation capability (pre-and post-closure) tives: (1) limiting the cumulative release at the accessible of the high-level nuclear waste (IILW) repository consti-environment boundary over 10,000 years; (2) individual tutes a performance assessment (PA). In this paper, how-protection objectives for the first 1000 years; and (3) re-l ever, PA is restricted to mean only quantitative post-quirements for protection of special sources of ground closure estimates of the repository's isolation capability, water for the first 1000 years. (For purposes of this docu-Furthermore, the quantitative estimates are restricted to ment,it is assumed that 40 CFR Part 191, though vacated those that are called for in relevant regulations, primarily by Court Order, will be repromulgated without material si 10 CFR lbri 60 and 40 CFR Part 191, change.) 'Ihe U.S. Department of Energy (DOE)is required, by In contrast, Part 60, the " Disposal of High-Level Radioac-regulation, to provide a comprehensive PA in its license tive Wastes in Geologic Repositories" is more compre-application. 'lhe law requires the Nuclear Regulatory hensive in its scope. The generally applicable environ-Commission to review the license application before mental standards of 40 CFR Part 191 are incorporated granting, or denying, a construction authorization. As a into 10 CFR Part 60 by reference. In addition, consistent part of the review process, NRC will form its own esti-with the mandate of NWFA, as amended,10 CFR Part 60 mates of the potential performance of the repository de-makes it explicit that a reposito y include a system of scribed in the license application. If it determines that it is multiple barriers. This concept of multiple barriers is en-necessary and appropriate to do so NRC may use inde-forced by establishing three minimum subsystem per-pendent calculations in forming these estimates. It should formance objectives, namely, the substantially complete be understood that PA is only one input, albeit important, containment performance objective for the waste pack-into NRC's decision-making process, as will be made clear age; the release rate performance objective for the engi-in the much broader Overall Review Strategy (ORS). It is nected barriers; and the ground-water travel time per-also worth noting that at no time during the life cycle of formance objective for the site. In addition to the repository is NRC expected to carry out its own site performance objectives, siting and design criteria (for investigations or perform any engineering design. It will, waste package and engineered barriers) are also specified however, provide guidance to DOE on both site charac-in 10 CFR Part 60. However, the subsystem performance terization and engineering design. objectives of 10 CFR 60.113(a), for the engineered barri-ers, apply only with respect to the " anticipated processes The general question considered in this paper is how and events " An additional flexibility with respect to the should NRC use pas in implementing its proactive and subsystem standards is included in 10 CFR 60.ll3(b). So reactive regulatory program? This breaks down to the long as the total system perforrnance objective is met for following issues: (1) where in its review of DOE's license anticipated processes and events, NRC can approve or application should NRC perform independent pas, and otherwise specify a radionuclide release rate, contain-(2) how should PA be used in the overall program? In ment time, or ground-water travel time other than the essence, what should be NRC's PA strategy, taking into nominal values stated in 10 CFR 60.113(a). account its mission and resource availability. With regard to judging compliance with these objectives 2 REGULATORY BASIS FOR (including the EPA standard) and criteria,10 CFR Part 60 i PERFORMANCE ASSESSMENT states: " Proof of the future performance of engineered bar-The regulatory requirements for the geologic repository rier systems and the geologic setting over time peri-are codified in 40 CFR 1%rt 191 (U.S. Environmental ods of many hundreds or many thousands of ycars is Protection Agency (EPA)) and 10 CFR Part 60 (NRC)- not to be had in the ordinary sense of the word. For two complementary, but independent regulations. Ibrt such long-term objectives and criteria, what is re-j 191, the " generally applicable standards for protection of quired is reasonable assurance, making allowance the general environment from off-site releases from ra-for the time period, hazards, and uncertainties D-1 NUREO-1495 l

l involved, that the outcome will be in conformance ness and adequacy of the site characterization program with those objectives and criteria." and engineering design, as well as on 1)OE's plans to construct, operate and close the repository Thus, NRC in the Supplementary Information Statement, the Com-has a definitu role to play throughout the life cycle of the mission explained that the subsystem performance objec-repository. tives of 10 CFR Part 60 are meant to provide confidence in meeting the overall system performance objective. Tech-It is conceivable that the NRC staff can form an opinion nical support is provided in NUREG-0804, Pan C, by about the performance of the repository without indepen-evaluation of the extent to which compliance with the dent calculations. However, because of the complexity of three subsystem performance objectives increases the the system and in the absence of accumulated historical likelihood of compliance with EPA's overall system per-experience, such an opinion will not be sufficiently well-formance criteria. Additional analyses of how the three founded to support licensing decisions. Therefore, NRC subsystem performance objectives increase thc likelihood should conduct its own pas. NRC must devise a plan of compliance with EPA's overall performance criteria are based on this strategy to select cri:ical portions of DOE's given in NUREG/CR-3111. 'Ihis technical support was license application for intensive review by independent prepared before promulgation of 40 CFR 15rt 191. An pas. This strategy should also help NRC in meeting its early working draft of 40 CFR Part 191 was used to carry obligations to provide guidance to DOE during site char-out the evaluation. EPA is currently in the process of acterization, construction, operation and closure. This reissuing 40 CFR Part 191, and changes from the earlier st rat egy will be implemented by all t he N RC organizations working draft and the remanded final version are uncer-involved in PA aspects of the High Level Waste Program tain. A PA capability will allow NRC not only to reevalu-and their contractors. ate the extent to which the subsystem performance objec-tives will provide additional confidence of compliance 4 STRATEGY FOR PERFORh1ANCE with EPA's standards, but it also will identify refinements ASSESSN1ENT to the subsystem objectives that might be appropriate. Because of the long period of regulatory concern (10,000 The key features of NRC's PA strategy are derived from a years set by EPA) and large spatial scales (tens of cubic few basic considerations: the complex and interdisciplin-kilometers), the future subsystem and total system per. ary nature of PA; its potential use in both the reactive and formance of the repository are expected to be projected by proactive programs; the top-down approach to guide re-way of mathematical models. Direct performance testing source utilization by identifying components important to of either the total system or its subsystems over such repository performance: the integration of technical work scales is not possible. DOE has the responsibility to devel. performed on how the subsystems work; and keeping the op, validate, and implement, to the degree appropriate, NHC staff knowledgeabic in PA methodology.These fea-tures are discussed below. these models and to provide a complete description of the pas in its license application. N RC, on the of her hand, has the responsibility of ensuring that the licensed repository 4.1 General Program will adequately protect public health and safety. In per-forming its regulatory function, the approach to be taken Assessing performance of a geologic repository requires will be one of reviewing DOE's entire PA at a broad level execution of a number of steps.These include conceptual-of detail and doing more detailed reviews in the most izing the system in terms of its identifiable components, significant areas. NRC must, therefore, decide which the formulation of mathematical models representing all selected parts should include independent verificatmn important processes, the translation of the mathematic:d through independent pas. NRC will adopt the strategy models into computer programs, the verification, and to described below in applying pas in its llLW work. the extent possible, validation of the models, the analyz-ing of field and labomtory data to extract model parame-3 NEEI) FOR NRC'S PERFORN1ANCE ter values, the executing of computer programs, perform-ASSESSN1ENTS ing sensitivity and uncertainty analyses, and, finally, analyzing results to draw conclusions. Many relatively complex technical issues of a multi. Although all parts of the pas presented by DOE will be disciplinary nature are involved in assessing the future reviewed at some level, critical parts will be selected for performance of the geologic repository.To meet the NRC in-depth review (see ORS for definitions of various review mission of protecting public health and safety, the NRC types). In reviewing DOE's pas, the NRC staff will not staff must, during the licensing process, take positions on need to duplicate the work done by DOE. DOE will per-the potential performance of the repository as it relates to form these calculations under an auditable quality assur-the performance objectives. In addition, NRC will com-ance (OA) program. As part ofits reactive HLW licensing ment on and provide guidance to DOE on the complete-program, the NRC will conduct audits as needed. The NUREG-1495 D-2 s

NRC staff will perform, at least at a rudimentary level, a repository performance; (3) techniques for probability es-calculation to check all the DOE estimates of perform-timation:(4) assessing reliability of long-term mathemati-ance. In addition, the NRC staff will use independent cal predictions: and (5) numerical methods (if needed). calculations to evaluate the significance of key assump-tions regarding conceptual models, process models, and llecause PA of nuclear waste repositories is a relatively parameter values included in DOE's pas. This evaluation new field and because it is interdisciplinary in nature, very will draw heavily from the proactive work described be-few formal educational opportunities exist to train staffin low. Other applications of PA in the review of DOE's this aspect. Although NRC has developed a course on PA, program wdl mclude determmation of the adequacy of learning through experience, by conducting limited pas,is performance allocations and other facets of the DOE's the best and most efficient method for training of the site characterization program. I articular attention will be NRC and contractor staffs. Insights gained by NRC staff given to evaluating DOE's evolving iterative PA program. will allow development of meaningful regulatory guid-Auxiliary analyses donc as part of independent pas will ance and review procedures. 'Ibgether with the NRC's also provide a technical foundation for evaluating alterna-Systematic Regulatory Analysis (SRA) program, PA mod-tives with respect to conceptual models, process models, cling alt ' ' vill help in evaluating current regulations re-parameter values, and sensitivity analyses presented by garding n r interrelationships, completeness, and suffi-DOE, and to identify those that may not be considered ciency r providing assurances that public health and adequately in DOE's work. Such work will provide techni-safety will be protected. cal credibility to recommendations that the NRC will make to DOE for its investigations. The NRC llLW re-search program will generate scientific information to 4.2 Integration of Subsystems support staff positions on whether alternatives have been adequately explored by DOE. NRC's regulations require that the total repository sys-tem should include engineered and natural barriers. Special attention will be paid to uncertainties involving 'these regulations also require that each of several barri-the assumptions that form the basis of models, future ers attain a certain performance objective. Therefore, t states of nature, and estimation of parameter values that these subsystem performance objectives have an impor-are fed into PA computer programs. Agaia, one may as-tant role in ensuring that the multiple barrier concept is sume that DOE's raw data will be collected under an maintained and thereby provide additional confidence approved QA program. 'lhe interpretation of Ihese data that public health and safety goals are met, in view of this, leading to model parameter values not only will be spot. the DOE is expected to develop a repository system that checked, but NRC, itself, will interpret selected data sets will be comprised of engineered and natural barriers. for criticM parameters. It is in the interpretation of these Hecause of potential complex interactions between these data that alternate hypotheses or inferences may be iden-barriers under future environmental states, the net im-tifier; that were not adequately considered by DOE. Spe-pact of individual barriers on the total system perform-cial attention may be directed to issucs identified by cxter. ance is not known a priori. Therefore, it is natural and nal l eviewers, as well as those identified by the N RC staff. necessary to account for all these barriers in conducting pas of the total system. The p-imary aim of NRC's proactive PA program will be to evalaate its regulations, develop sound technical guid. It has recently been suggested that there is a need to ance, tra:n and keep its staff current, and develcp appro. reevaluate the relationship between the subsystem per-priate tect nical review methods in the License Applica-formance requirements of 10 CFR Part 60 and the EPA tion Revie v Plan (LARP). NRC will use the DOE. IiLW standard. As discussed previously, the staff will do developed computer codes, if availabic, provided that this reevaluation in connection with repromulgation of the EPA standards. This reevaluation will exarnine the these codes have enough flexibility to also allow NRC evaluation of DOE assumptions about conditions that extent to which meeting subsystem requirements of 10 may have public health and safety implications and the CFR 60.113 relates to compliance with the EPA stan-sensitivity of DOE's conclusion to these assumptions. dards. The data and analyses needed for compliance de-Otherwise,.NRC will develop its own codes or modify termination with requirements of 10 CFR 60.113 will also be examined. existing codes to suit its purpose. The proactive program will be also supported through NRC's llLW research program (see draft NUREG-1406). PA issues that are The relative contribution of each barrier in meeting the related directly to NRC's regulatory function of technical total system performance objective can be determined review will be addressed through NRC's ifLW research only after such an assessment of total system performance I program. Such issues will melude:(1) understanding pro-is conducted. Therefore, from the PA view, there is no cesses that affect IILW repository performance: (2) un-nat ural hierarchy to subsystems, t hat is, all subsystems will derstanding coupling among processes that affect ilLW be considered during pas of the total system. D-3 NUREG-1495

l \\ Depending on their relative importance, which will be making these judgments, it is axiomatic that complete determined during initial iterations, eventually and for scientific understanding of processes, fully validated com-certain purposes (e.g., sensitivity analyses) some subsys-putational tools, and complete and unambiguous site-tems may be treated in more detail than others. specific data are objects to be strived for, but are unable to be achieved.Therefore, NRC recognizes that judgments will be made under conditions of substantial uncertainty, Irrespective of the relative importance of any barrier in that {t h neway tg Icam to use b Wan pc&ct an meeting the EPA standard for the total system perform-c mputational tools and mcomplete data sets. ance, subsystem pas will be conducted to judge whether the subsystem performance objectives of Part 60 are met. As stated before, the subsystems do not perform indepen. There are several other reasons why the iterative PA dently of each other; that is, the performance of the engi-approach will be followed. Iterations will be invaluable in neered barriers is determined by 1he site conditions and pointing out the shortcomings in existing models and data, vice versa. Also, due to large time and space scales in-and will also indicate topics in need of further investiga-herent in the subsystem performance objectives, like the tions or research. We will strive for incremental improve-total system, the subsystem pas will also require mathe-ments in understanding of processes, computational matical modeling. In view of the above, it is possible that tools, and data, in each iteration. It is also imperative that the assessments of the subsystems can become a part of the iterative pas perform a technical integration function the total system pas. Ilowever, it is also possible to inves-by being truly inter-disciplinary. Thus, the concepts devel-tigate the performance of these subsystems in greater oped for the engineered subsystem and the natural sub-detail by isolating them within properly selected bound-system must be brought together in each iteration of the aries. Initially, both options will be followed by the NRC PA. staff. Ilowever, eventually the subsystem PA efforts and the total system performance efforts will be thoroughly integrated. This wi!! he done by imp!cmenting an " inter-4.4 Top-Down Approach to Resource disciplinary team approach" m conductmg the pas. Ihe M oc a h.on members of the various teams will be drawn from various NRC branches involved with the llLW program's offices and sutrontractors. Suitable management controls will be Iterative PA will provide an important input to deciding designed and implemented for the success of the team wwk priorities in both the Nuclear Material Safety and Safeguards (NMSS) and Nuclear Regulatory Research approach. offices, in order to best use limited resources. This input will be in the form of problems identified during iterative pas that need a solution. In addition to identification of 4.3 Timing and Iterative Nature of problems, iterative PA, especially sensitivity and uncer. Assessments tainty analyses, will show which specific uncertainties con-tribute most to uncertainties in performance and, there-There are two different approaches to decide upon.he fore, might pose a threat of noncompliance with the right time to carry out a PA. In the first approart, one performance objectives (referred to as key technical un-wait.4 until the computational tools are fully developed certainties). Such key technical uncertainties are ad-and the collection of site-specific data is complete before dressed in the ORS and LARP. Obviously, priorities indi-attempting a PA. In the second approach, iterative pas are cated by PA should be considered in conjunction with carried forward with the help of available data at a given needs identified by other means. time with computational tools available at that time. From a regulatory perspective, the second approach should receive the highest priority by the NRC staff.This 4.5 Training of Staff approach should apply to both the subsystem and the total system pas' Iterative pas combined with participation in international performance assessment programs such as INTRAVAL Performance assessment of geologic repositories,includ-will keep the NRC staff current on pertinent methodolo-ing engineering barriers, is inherently iterative in nature. gies. This is an essential step in providing assurance that llecause different conceptual models must be explored, the staff w ill have at its disposal the nceded skills to review the effect of various simplifications must be assessed. and critically DOE's pas at the time of license application uneven and sparse data must be dealt with. The selection review. Of equal importance, it will provide the staff with of iterative pas as the primag NRC staff approach is needed tools for developing regulatory guidance and ad-based on the fact that NRC has responsibihty to make a ditional reactive work, such as review of prelicense sub-series of judgments during site characterization and li-mittals, including site characterization data and interac-cense review, for which PA is needed. Additionally, in tions with DOE, State of Nevada, and affected panics. NUREG-1495 D-4

5 PROGRAMMATIC PRIORITIES SRA program, which is investigating technical uncertain-ties related to model validation, scenario identification, data uncertainty, and use of expert judgment. Depending i Ilighest priority in the near term will be given to develop, on SRA program results, rulemaking may also be war-

ranted, ing staff and contractor technical capabilitics in the con.

duct of pas. Progress has already been made, as indicated In the future iterations, high priority will be given to by the recently released staff report entitled, " Phase I Demonstration of the Nuclear Regulatory Commission's integration of the subsystem PA work with the total sys-tem PA and assessment of key technical uncertainties Capability to Conduct a Performance Assessment for a llLW Repository"(April,1990).The second phase of this dentified by the staff consistent with ORS. In the present effort has been initiated and is intended primarily to com-organizational structure, important work on the subsys-bine the knowledge of specialized technical disciplines tems, including compliance determination with respect to (engineering and carth sciences) with those of the system the siting and design criteria of 10 CFR Part 60, is being modelers, to produce integrated pas. Special attention funded separately. Irrespective of the funding mecha. will be directed toward improvements in methodology for nim, a plan to implement a team approach for integra-scenario identification and screening, retardation phe_ don of work with respect to each one of the subsystem pas nomena, mechanistic treatment of radionuclide release will be developed. 'Ib be successful, each team must be and near-field coupled effects, disruptive consequences, compttsed of experts from different disciplines interested and alternative sensitivity and uncertainty analysis meth-in a particular subsystem and the total system. The com-ods. Of equal importance in this effort is a planned evalu-positions of the teams, the responsibilities of the team ation of the effects of the NRC subsystem requirements leader, relation of the teams to hne management, and on EPA Standard compliance. funding of the work of the teams will be the subject of the "NRC Performance Assessment implementation Plan." Skills acquired in the Phase-I development exercise and 6 UPIMTING OF STRATEGY the planned second phase will have immediate applicabih-ty to the other Iwo principal areas of PA work: support to the DOE program review and the development of regula-The NRC PA strategy will be reviewed periodically (once a tory guidance for use by the staff and DOE. The staff year)and updated based on passible program redirection. Phase 1 effort has already had substantial influence in This applies especially to the updating of programmatic dealings with DOE in its site characterization activities priorities stated in the last section. The proportion of and led to the staff's first formal technical exchange with reactive and proactive PA work may also change from year DOE on PA (November 27-29,1990). Immediate benefits to year depending upon the extent and nature of DOE's also accrue to the regulatory guidance efforts under the pre-license submittals. l D-5 NUREG-165

NRC FORM 335 U.S. NUCLEAR REGULATORY COMMISSION 1 REPORT NUMBEF-( Arsigned by NRC, Add Vol., (2.80) Supp., Rev., tsid A ddendum Num-NRCM 1102, ba'*- ""Y 4 3201 3202 BIBLIOGRAPHIC DATA SHEET NUREG-1495 (See instructions on ene rev.rse)

2. TITLE AND SUBilf LE Overall Review Strategy for the Nuclear Regulatory Commission's High-Level
a. DATE ReeORT euBusHeD Waste Repository Program MONTH YEAR November 1994
4. FIN OR GRANT NUMBER
6. AUTHO4t6)
6. TYPE OF REPORT Final R. L Johnson
7. PERIOD COVERED (inclusive Dates)
8. Pt.4 FORMING ORGANi/ATION - NAME AND ADDRESS Of NRC, provide Divesion, Office or Reguan, U.S. Nuclear Regulatory Commission, and

~ mailing address; if contractor, provide name and mailing address. ) Division of Waste Management Office of Nuclear Materials Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

9. SPONSORING ORGANIZATION - NAME AND ADDRESS Of NRC, type "Same as above"; if contractor, provsos NRC Division, Office or Reg!on, U.S. Nuclear Regulatory Commission, and mailing address.)

Same as above

10. SUPPLEMLNT ARY NOTE 8
11. ABSTRACT (200 words or 6ess)

The Overall Review Strategy gives general guidance to the Nuclear Regulatory Commission staff for conducting it's license application and pre-license application reviews. Rese reviews are in support of the Commission's construc-tion authorization decision for a geologic repository for the disposal of high-level radioactive waste. Objectives and strategies are defined that focus the staff's reviews on determining compliance with requirements of 10 CFR Part 60. These strategies define how the staff prioritizes its reviews on those key technical uncertainties considered to be most important to repository performance. Strategies also give guidance for developing, in an integrated way, the License Application Review Plan together with supponing performance assessments, analyses, and research. 13, AVAILABILfTY STATEMENT

12. KEY WORDS/DE SCRIPTORS (List words or phrases that will assist researchers in locating the report.)

Unlimited is. sECuRn assiFicAnON High-Level Radioactive Waste Licensing Unclassified Geologic Repository (This iteport) License Application Review Plan Unclassified Performance Assessment 4 NUMUER 06 PACsE S Ouality Assurance Pre-Licensing Review Systematic Regulatory Analysis

16. PRICE NP,C FORM 335 (2-49)

Printed on recycled paper Federal Recycling Program

d NUREG-1495 - OVERALL REVIEW STRATEGY FOR TIIE NUCLEAR REGULATORY COMMISSION'S.. . NOVEMBER 1994 : IIIGil-LEVEL WASTE REPOSITORY PROGP.AM 1 I UNITED STATES FIRST CLASS Mall' NUCLEAR REGULATORY COMMISSION POSTAGE AND TEES PAfD :. WASHINGTON, D.C. 20555-0001 USNRCJ . PERMIT NO. G. i OFFICIAL BUSINESS I PENALTY FOR FRIVATE USE, $300 l ..) I 1 L o I \\

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