NUCLEAR REGULATORY COMMISSION · LSS CENTRAL FILE MFederline, HLHP iOFC __ LPD | in I N AME AGardi,, / knhAn1f JY 1b od DATE 03/2/93 ' /_ _93____ ... Regulatory Guide DG-3003,

89001847

OAR 2 5 193

MEMORANDUM FOR: John T. Larkins, Acting Executive DirectorAdvisory Committee on Nuclear Waste

FROM: B. J. Youngblood, DirectorDivision of High-Level Waste ManagementOffice of Nuclear Material Safety

and Safeguards

SUBJECT: SUBMITTAL OF UNCERTAINTY REPORT

In the March 25, 1993 Division of High-Level Waste Managemnet (HLWM) staffbriefing on the "Clarification of Assessment Requirements for the SitingCriteria and Performance Objectives" rulemaking, information was requested oncriteria used to categorize regulatory and institutional uncertainties aseither rulemakings, regulatory guidance, or further analysis. In response tothat request, the staff committed to provide a copy of the UncertaintyReduction Report. Enclosed are five copies. The specific criteria arediscussed in Section 4.2, "Uncertianty Reduction Recommendation Categories,"which begins on page 12. For each uncertainty analyzed, an individual staffassessment is contained in Appendix A, "Regulatory and InstitutionalUncertainty Reduction," which provides the rationale for why the appropriatecriteria were met.

If you have any questions, you may contact Mr. Joseph Holonich of my staff at504-3387.

B. J. Youngblood, DirectorDivision of High-Level Waste ManagementOffice of Nuclear Material Safety

and Safeguards

Enclosure:As stated

CNWRALPDRBJYoungblood, HLWMJHolonich. HLPD

NMSS R/FACNWJLinehan,On-Site I

DISTRIBUTION w/o EnclosureHLPD R/FPDR

, HLWM RBallard, HLGEZens

LSSCENTRAL FILEMFederline, HLHP

iOFC LPD ____ | in I

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DATE 03/2/93 ' __/_ _93____

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OFFICIAL RECORD COPY

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W1-1

UNITED STATESNUCLEAR REGULATORY COMMISSION

C WASHINGTON, 0. C. 20555

MAR 2 5 1993

MEMORANDUM FOR: John T. Larkins, Acting Executive DirectorAdvisory Committee on Nuclear Waste

FROM: B. J. Youngblood, DirectorDivision of High-Level Waste ManagementOffice of Nuclear Material Safety

and Safeguards

SUBJECT: SUBMITTAL OF UNCERTAINTY REPORT

In the March 25, 1993 Division of High-Level Waste Managemnet (HLWM) staffbriefing on the 'Clarification of Assessment Requirements for the SitingCriteria and Performance Objectives' rulemaking, information was requested oncriteria used to categorize regulatory and institutional uncertainties aseither rulemakings, regulatory guidance, or further analysis. In response tothat request, the staff committed to provide a copy of the UncertaintyReduction Report. Enclosed are five copies. The specific criteria arediscussed in Section 4.2, Uncertianty Reduction Recommendation Categories,"which begins on page 12. For each uncertainty analyzed, an individual staffassessment is contained in Appendix A, 'Regulatory and InstitutionalUncertainty Reduction,* which provides the rationale for why the appropriatecriteria were met.

If you have any questions, you may contact Mr. Joseph Holonich of my staff at504-3387.

B. J oungblo DirectorDi v on of High-Level Waste ManagementOf I e of Nuclear Material Safety

and Safeguards

Enclosure:As stated

4

- . .I ____

APR 1 1991URT MEMO FOR BJY

MEMORANDUM FOR: B. J. Youngblood, DirectorDivision of High-Level Waste Management

THRU: John J. Linehan, Deputy DirectorDivision of High-Level Waste Management

FROM: Ronald L. Ballard, ChiefGeosciences & Systems Performance BranchDivision of High-Level Waste Management

Joseph 0. Bunting, ChiefEngineering BranchDivision of High-Level Waste Management

Joseph J. Holonich, Acting DirectorRepository Licensing and QualityAssurance Project Directorate

Division of High-Level Waste Management

SUBJECT: REPORT ON UNCERTAINTY REDUCTION

Enclosed is the task team report, "Systematic Regulatory Analysis Regulatoryand Institutional Uncertainty Reduction Recommendations." The task teamreviewed the regulatory and institutional uncertainties identified by theCenter for Nuclear Waste Regulatory Analyses (CNWRA) in CNWRA 90-003,"Identification and Evaluation of Regulatory and Institutional UncertaintiesIn 10 CFR Part 60," and by the staff in SECY-90-207, "First Update of theRegulatory Strategy and Schedules for the High-Level Waste Repository Program,"and has recommended techniques for reducing the 49 uncertainties considered.The majority of the work required to reduce the identified uncertainties willbe carried out as part of presently budgeted activities. The exceptions wouldbe those items for which the recommended reduction approach involves minor rulechanges or, in some cases, where further analysis has been recommended. Thestaff found many of the uncertainties to be of a minor nature and it isthe staff's belief that these uncertainties are addressed in the DraftRegulatory Guide DG-3003, "Format and Content for the License Application forthe High-Level Waste Repository" (FCRG) or can be addressed in the finalversion of the FCRG or in the License Application Review Plan.

A major open issue between the staff and the CNWRA concerning a group ofuncertainties related to the adverse conditions of 10 CFR 60.122 has beenidentified. The staff believes that the requirements of 10 CFR 60.122 are tobe considered in relation to the performance objectives (e.g., 10 CFR 60.112and 10 CFR 60.113). The CNWRA staff has proposed a different interpretationof the rule. Therefore, these uncertainties have been placed in the "furtheranalysis" category pending discussions on April 25, 1991 between the CNWRA andNRC management and staff to attempt to resolve the issue. We will report to youyou after that meeting on the final recommended resolution of those uncertainties.

I

URT MEMO FOR BJY-2-

The need for this task was identified to the Commission In SECY-90-207in June, 1990. At that time the staff proposed a two part effort to resolveexisting identified regulatory and institutional uncertainties. The first partwas an effort to select the appropriate reduction methods. The attached reportcompletes and documents that activity. The second part, which the staffpresented as Its initial view, was to prepare a single staff position toresolve most of the uncertainties that would not be reduced by ongoing orplanned rulemakings or that were not significant enough to warrant a specialstaff position. However, as documented in the enclosed report, the staffconcluded that no staff positions were needed at this time. The staff willinform the Commission of the status of this activity in its next update toSECY-90-207 which is scheduled for June 1991.

If you need further information on this report, please contact Philip M.Altomare, the task team leader.

ORIGINAL SIGNED BY

Ronald L. Ballard, ChiefGeosciences & Systems Performance BranchDivision of High-Level Waste Management

ORIGINAL SIGNED BY

Joseph 0. Bunting, ChiefEngineering BranchDivision of High-Level Waste Management

ORIGINAL SIGNED BY

Joseph J. Holonich, Acting DirectorRepository Licensing and QualityAssurance Project Directorate

Division of High-Level Waste Management

Enclosure: As stated

Distribution and Concurrence on following page

I

K> I- b I

URT MEMO FOR BJY- 2 -

DISTRIBUTION

CNWRALPDRBJYoungblood, HLWMOn-Site Reps

NMSS R/FACNWJBunting, HLENMDelligatti HLPD

HLPD R/FPDRJLlnehan, HLPDJHolonich,HLPD

LSSCentral FileRBallard, HLGPPAltomare

OFC :HLPD :HLPD | :H D :HLWM :HLEN 4______ ~ -- _ ___ , -- --- -t --------------- ^T------------

NAME:MDelligatti:PAltomare :Jh itonJch an :A11f'rd :JBuntli1bf________________________________ *y~--------t- d r------------------

Date:03/A/91 :03/kV191 :3 91 : 1/91 : 0// /91 :03/ /91

OJC .OGC/----- ------------------------------------------------------------ _-____------

N ANE:S -eby :; t ----- ----------------------------------________________________Date: t //91 : :

OFFICIAL RECORD COPY

amt 'ci Z~t .ZL

SYSTEMATIC REGULATORY ANALYSIS

REGULATORY AND INSTITUTIONAL UNCERTAINTY

REDUCTION RECOMMENDATIONS

U.S. Nuclear Regulatory Commission

Office of Nuclear Material Safety and Safeguards

A+&�4L�Q2-7 elvp

SYSTEMATIC REGULATORY ANALYSIS

REGULATORY AND INSTITUTIONAL UNCERTAINTY


Date: March 29, 1991

Task Team

P. H. Altomare, Team LeaderM. DelligattiT. Romine, CNWRA AdvisorS. Spector, CNWRA AdvisorN. TaniousR. NeelJ. TrappR. WellerJ. Wolf, Office of the General Counsel

Division of High-Level Waste ManagementOffice of Nuclear Material Safety and SafeguardsU.S. Nuclear Regulatory CommissionWashington, D.C. 20555

TABLE OF CONTENTS

Page

1. Executive Summary 11.1 Background 11.2 Uncertainty Reduction Recommendations 11.3 Uncertainty Reduction 2

2. Introduction 3

3. Identified Regulatory and Institutional Uncertainties 5

4. Uncertainty Evaluation 114.1 Evaluation Task Team 114.2 Uncertainty Reduction Recommendation Categories 12

5. Evaluation Summary 155.1 Assessment of Potentially Adverse Conditions 155.2 Uncertainty Reduction Activities 18

6. Continued Identification of Uncertainties 21

7. References 22

Appendix A, "Regulatory and Institutional Uncertainty Reduction"

LIST OF TABLES

1. Regulatory and Institutional Uncertainties 6

2. Tasks for Reducing Major Rule Change and Further 19Analysis Uncertainties

i

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SYSTEMATIC REGULATORY ANALYSISREGULATORY AND INSTITUTIONAL UNCERTAINTY


1 EXECUTIVE SUMMARY

1.1 Background

The purpose of this report is to present the staff's findings andrecommendations for reducing previously identified potential regulatory andinstitutional uncertainties in 10 CFR Part 60, "Disposal of High-LevelRadioactive Waste in Geologic Repositories."

At the request of the U.S. Nuclear Regulatory Commission (NRC) staff, theCenter for Nuclear Waste Regulatory Analyses (the Center), an NRC sponsoredFederally Funded Research and Development Center, performed an analysisof 10 CFR Part 60 to identify potential regulatory and institutionaluncertainties. The final results of the analysis are reported in CNWRA 90-003,"Identification and Evaluation of Regulatory and Institutional Uncertainties in10 CFR Part 60." In that report, the Center identified 42 potentialuncertainties. The NRC staff also identified seven potential uncertainties andreported them in SECY 90-207, "First Update of the Regulatory Strategy andSchedules for the High-Level Waste Repository Program." SECY-90-207 alsoidentified an institutional uncertainty regarding the Resource Conservation andRecovery Act (RCRA). Because the reduction of this uncertainty is documented inSECY-90-207 it is not addressed in this report.

To address each of the identified uncertainties, the NRC formed a taskteam to review the identified potential uncertainties and to recommend anuncertainty-reduction approach for each uncertainty. This report presentsthose recommendations.

1.2 Uncertainty Reduction Recommendations

The staff's assessment of the 49 identified potential uncertainties is providedin Appendix A. In its assessment, the task team identified four regulatory andinstitutional uncertainty-reduction categories: Guidance; Minor Rule Change;

1

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Major Rule Change; and Further Analysis. Criteria were established for thesecategories, and each potential uncertainty was analyzed to determine Itsappropriate category. A rationale for the category selection is included foreach potential uncertainty in Appendix A. There are 49 potential uncertainties,of which 24 were placed in the Guidance category, three were placed in theMinor Rule Change category, seven were placed in the Major Rule Change category and15 were in the Further Analysis category. These categories are defined inSection 4.2.

1.3 Uncertainty Reduction

The largest number of uncertainties were placed in the Guidance category. Inthese cases, while the staff considered the intent of the rule clear, therewas a recognition that other parties might find additional information usefulto avoid varying interpretations of the rule. Regulatory guidance documentsunder development such as the Draft Regulatory Guide DG-3003, "Format andContent for the License Application for the High-Level Waste Repository" (FCRG)the License Application Review Plan (LARP), and various staff technical positionsare the appropriate sources of guidance to be considered to reduce theseuncertainties.

The Minor Rule Change category contains those uncertainties where a minorcorrection is needed to 10 CFR Part 60. The Major Rule Change categorycontains those uncertainties where the need for rulemaking has been previouslydocumented by specific reservations in 10 CFR Part 60, issued as a notice ofproposed rulemaking, or approved by the Executive Director for Operations (EDO)for rulemaking. The Further Analysis category includes those uncertainties thatcannot be placed in one of the preceeding categories until an additionalpolicy and/or technical evaluation of the topic has been conducted to serve asa basis for a determination on an uncertainty reduction method.

2

I

2. INTRODUCTION

NRC's Office of Nuclear Material Safety and Safeguards (NMSS), Divisionof High-Level Waste Management (HLWM) has Initiated a systematic regulatoryanalysis (SRA) of 10 CFR Part 60. The SRA is a process by which the regulatoryrequirements for licensing a high-level waste repository are analyzed in asystematic, structured manner controlled by technical operating procedures. Aspart of the SRA process, a framework for regulatory analysis that identifiesregulatory, institutional, and technical uncertainties is established. Thedefinitions of regulatory and institiutional uncertainties, as given in CNWRA90-003 are:

Regulatory Uncertainty

"Lack of certitude as to what is meant by a regulatory requirement or theadequacy, completeness, and/or necessity of the requirement itself.Regulatory uncertainty may stem from lack of clarity in the statedrequirement, the omission of an essential requirement from the regulation,and/or the inclusion of requirements in the regulation that do notcontribute to or detract from the regulatory program."

Institutional Uncertainty

"Lack of certitude regarding the roles, missions, actions, and schedulesof agencies with regulatory requirements that affect the high-level wasteregulatory program, their impacts, or their integration with the NRC staffregulatory program."

The definition for technical uncertainties can be found in CNWRA TechnicalOperating Procedure TOP-001-02, "Program Architecture Relational DatabaseContent and Development Instructions:"

Technical Uncertainty

"Lack of certitude as to (1) how to demonstrate (DOE action) or determine(NRC action) compliance, (2) how to acceptably reduce a previouslyIdentified technical uncertainty, or (3) how to obtain the requisiteinformation for either purpose."

The Center was tasked to perform an independent analysis of 10 CFR Part 60, andidentify potential areas of regulatory and institutional uncertainty. It isimportant to note that technical uncertainties were not part of the Center'sanalysis of the task team considerations and are not addressed in this report.

3

I.

The Center, in its independent analysis of 10 CFR Part 60 was directed to erron the side of inclusion-of uncertainties, if doubt on the subject existed.The results of the Center's analyses are included in two reports, CNWRA 89-003,"Identification and Evaluation of Regulatory and Institutional Uncertainties In10 CFR Part 60, Subparts B and E,"1 May 1989, and CNWRA 90-003, "Identificationand Evaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60,' February 1990. The analyses of Subpart B, "Licenses", and Subpart E,"Technical Criteria," were performed on an accelerated basis, since thesesubparts were of particular value in reviewing DOE's Site CharacterizationPlan. CNWRA 90-003 covered all subparts of 10 CFR Part 60 and incorporated theresults of the first report.

In addition to the Center-identified uncertainties, the NRC staff hadidentified several regulatory and institutional uncertainties in itsprelicensing reviews of DOE documents, preliminary performance assessments,other technical work, and research. Uncertainties identified by this work werefirst reported in SECY 88-285, "Regulatory Strategy and Schedules for theHigh-Level Waste Repository Program" and subsequently in SECY-90-207, "FirstUpdate and Schedules for the High-Level Waste Repository Program."

As a result of the identification of these uncertainties, the NRC established atask team to review the potential uncertainties that were identified and torecommend an uncertainty-reduction approach. The purpose of this report is topresent the staff's findings and recommendations for reducing these potentialregulatory and institutional uncertainties.

4

3. IDENTIFIED REGULATORY AND INSTITUTIONAL UNCERTAINTIES

In Section 2 of this report, it was stated that the potential regulatory andinstitutional uncertainties identified by the Center were first reported inCNWRA 89-003 for 10 CFR Part 60, Subparts B and E and CNWRA 90-003, for all of10 CFR Part 60. A number of the initial uncertainties identified by the Centerin its first report were later excluded as having been reduced by subsequentrulemaking, or relevant material publication, or reclassification as technicaluncertainties. In the second report, the Center identified a total of 42regulatory and institutional uncertainties for further characterization andconsideration of uncertainty reduction. Of the potential uncertainties, 2were institutional and 40 were regulatory.

In addition to the potential uncertainties the Center identified, the NRC staffidentified seven regulatory uncertainties. Three of the NRC staff-identifieduncertainties have now been resolved by publication of NRC staff positionsin the Federal Register, but are included in Table I and Appendix A.

The 49 total potential regulatory and Institutional uncertainties are listed inTable 1. Table 1 includes:

1. an uncertainty reference number, for reference in this report;

2. the 10 CFR Part 60 citation where the uncertainty occurs;

3. an abbreviated uncertainty statement;

4. a category for a recommended uncertainty reduction approach, derivedas discussed below;

5. an identification of the responsible HLWM branch with primaryresponsibility for the uncertainty; and

6. a cross-reference to the page, in Appendix B of the CNWRA 90-003report, that identified the potential uncertainty or a reference toSECY 90-207.

An indication as to whether it is a regulatory or institutional uncertainty isalso provided.

5

TABLE 1

REGULATORY AND INSTITUTIONAL UNCERTAINTIES

UNCERTAINTYREFERENCENUMBER

1.

2.

3.

10 CFR 60CITATION

10(b)

23

21

4.

5.

6.

24(a)

22(d)

31

ABBREVIATED UNCERTAINTY STATEMENT

Information having significant implications"

"Environmental Report" vs. "EIS"

Detailed content of application not in10 CFR 60.21

Criteria used to accept the license applicationfor docketing

Responsibility for Public Document Room

Consideration of performance confirmationduring construction authorization

Unpublished Subpart I in 10 CFR Part 60

Clarify "substantially increasing retrievaldifficulty"

Compliance demonstration/determinationregarding human intruders and recordarchiving

"Construction problems" need clarification

"Anomalous condition" needs clarification

UNCERTAINTYREDUCTIONCATEGORY

Guidance

Min.Rule

Guidance

Analysis

Min.Rule

Mmn.Rule

Maj.Rule

Guidance

Guidance

Guidance

Guidance

BRANCHPRIMARYRESPONSIBILITY

HLPD

HLPD

HLPD

HLPD

HLPD

HLPD

HLPD

HLEN

HLPD

HLEN

HLEN

CNWRAREPORT(App. B)

1

5

7

8

10

12

7.

8.

31(a)(5)(SEE ALSO43)

46(a)(1)(SEE ALSO16)

51(a)(2)(ii)

14

20

9. 22

10.

11.

72(b)(6)

72(b)(7)

28

29

*1

TABLE 1 (conted)



10 CFR 60CITATION

ABBREVIATED UNCERTAINTY STATEMENT UNCERTAINTYREDUCTIONCATEGORY


CNWRAREPORT

12.

13.

14.

15.-.A

16.

17.

73

73(b)

111(a)

111(a)

111(b)(1)(SEE ALSO 8)

112(SEE ALSO 21,22)

112

113(a)(1)(i)(A)

135(C)(1) *

113(b)(SEE ALSO

17, 22)

113(c)

Substantial safety hazard

Significant deviation

Reference clarification

Design radiation dose criteria

Facilitate versus not preventwaste retrieval

"Anticipated and Unanticipated Processesand Events"

Amendments to 10 CFR 60.112 to conformto EPA Standard

"Substantially Complete Containment"

Solid waste form

Anticipated processes and events

Guidance

Guidance

Guidance

Maj. Rule

Guidance

Maj. Rule

Maj. Rule

Analysis

Guidance

Maj. Rule

HLGP

HLGP

HLGP

HLEN

HLEN

HLGP

30

31

38

40

43

48

18. HLEN 51

19.

20.

21.

HLEN 55

HLEN

HLGP

57

63

22. Unanticipated processes and events Maj. Rule HLGP 66

TABLE 1 (cont'd)



23.

24.

25.

26.

27.

28

29.

30.

31.

10 CFR 60CITATION

121(a)(1)

122(b)(1)(SEE ALSO 30)

122(a)(2)(1)(SEE ALSO 26,27, 28, 29)

122(a)(2)(ill)

(SEE ALSO 26,27, 28, 29)

122(a)(2)(i)(SEE ALSO 25,26, 28, 29)

122(a)(2)(i)(SEE ALSO 25,26, 27, 29)

122(a)(2)(r)(SEE ALSO 25,27, 28)

122(b)(1)

21(c)(1),(ii)C, 122


Milestone for land ownership and control

Clarification of "Geologic Setting"

"Taking into account the degree of resolution"

"Not to affect significantly"

Need for criteria for "adequatly evaluated"

Meaning of "not likely to understimate effect"

Need for criteria for "adequately investigated"

Definition of "geologic setting"

Treatment of combinations of potentiallyadverse conditions


Guidance

Analysis

Analysis

Analysis

Analysis

Analysis

Analysis

Analysis

Guidance


HLPD

HLGP

HLGP

HLGP

HLGP

HOGP

HLGP

HLGP

HLGP

CNWRAREPORT

69

74

82

84

86

91

93

97

103

TABLE 1 (cont'd



32.

33.

34.

to0 35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

10 CFR 60CITATION

122(c)(3)(SEE ALSO 33)

122(c)(4)(SEE ALSO 32)

122(c)(8)

122(c)(16)

122(c)(24)

131(b)(5)

131(b)(6)

131(b)(9)

131(b)(10)

133(e)

Subpart I

122,112

133,111,112113


Meaning of "regional ground water flow system"

Meaning of "regional ground water flow system"

Sorption of radionuclides

Clarification of "Extreme Erosion"

"Air-filled" pore spaces

Design all utility testing for essentialfunction

"Design to permit periodic inspection"

Secondary effects/non-radiological accidents

Insufficient guidance in design criteria

Will NRC regulate non-radiological safety?

Subpart I

Applicability of siting criteria to performanceobjectives

Applicability of thermal load requirementto performance objectives


Analysis

Analysis

Analysis

Gui dance

Guidance

Gui dance

Guidance

Guidance *

Gui dance

Guidance *

Maj.Rule

Guidance

Guidance


HLGP

H.GP

HLGP

HLGP

HLGP

HLEN

HLEN

HLEN

HLEN

HLEN

HLPD

HLGP

HLEN

CNWRAREPORT

106

108

110

120

126

136

138

147

153

155

160

*Institutional uncertainties

TABLE 1 (cont'd)



45.

46.

47.

48.

49.

10 CFR 60CITATION

113(a)(1)(ii)(A)

113(a)(ii)(8)

131(b)(9)

10 CFRPart 2.1003

113(a)(1)(ii)(A)


Waste package containment time frame

Engineered barrier system release ratelimit

Reference to applicable mine safety requirements

Topical Guidelines for Licensing Support System

Criteria for containment of Greater-Than-Class-C


Guidance

Analysis

Analysis

Guidance

Analysis


HLEN

HLEN

HLEN

HLPD

HLEN

CNWRAREPORT

r

4. UNCERTAINTY EVALUATION

4.1 Evaluation Task Team

As discussed earlier, a task team was formed to evaluate an uncertaintyreduction for each of the potential uncertainties. The team was composed ofindividuals from the three HLWM branches: Engineering Branch (HLEN);Geoscience and Systems Performance Branch (HLGP); and the Repository Licensingand Quality Assurance Project Directorate (HLPD). The Office of General Counsel(OGC) and the Center (in an advisory capacity) were also on the team. Thescope of the task team's considerations was limited to the regulatory andinstitutional uncertainties identified in the CNWRA 90-003 report and theSECY 90-207 Commission paper.

The task team developed criteria for evaluating an appropriate uncertainty-reduction recommendation based on four categories of uncertainty reduction:Guidance, Minor Rule Change, Major Rule Change, and Further Analysis. Ananalysis was performed and rationale prepared by appropriate technical andlegal staff, with assistance from the team, to support the uncertainty-reductionrecommendation for each identified uncertainty. The recommendation andsupporting rationale have been reviewed by the HLWM branches and the OGCRulemaking and Fuel Cycle Division, with assistance from the Hearings andEnforcement Division. The HLWM Branch Chiefs had lead responsibility for theuncertainty-reduction category selection and rationale.

The uncertainty recommendation approaches applied by the task team are intendedto be applicable for future evaluation of any additional regulatory orinstitutional uncertainties that may be identified in the future.

The uncertainty-reduction recommendation for each regulatory and institutionaluncertainty is prepared in a standard format, as presented in Appendix A. Theformat is consistent with that applied in the Center's CNWRA 90-003 report andthe requirements for entry into the Program Architecture Support System (PASS)

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database. Significant regulatory and technical information developed underthe SRA of 10 CFR Part 60 is captured in the PASS database. The standarduncertainty-reduction recommendation format includes the following.

Standard Format Element Description

Uncertainty Number

Uncertainty Title

The number assigned In accordance withthe uncertainties in Table 1 (followedby a reference to the originalsource of the uncertainty).

A brief statement of the uncertaintybeing addressed (usually directly fromthe source document).

The provision of 10 CFR Part 60 thatcontains the uncertainty.

Citation

Text of theUncertainty

Potential A direct statement of the uncertaintyfrom the source.

Recommended Resolution Approach

Recommendation Rationale

References for Rationale

The category of uncertainty reduction,followed by a brief summarystatement.

The rationale supporting therecommended resolution approach.

Listing of references.

4.2 Uncertainty-Reduction Recommendation Categories

This section presents a detailed discussion of the four uncertainty reductionrecommendation categories established by the task team. Included in thediscussion for each category are the specific instruments that can be used toreduce the uncertainty, and the criteria used to place an uncertaihty in thiscategory.

Guidance

For uncertainties In the Guidance category, while the staff considered theintent of the rule to be clear, there was a recognition that other parties mightfind additional information useful to avoid varying interpretations of the rule.

12

Regulatory or institutional uncertainty clarification can be provided in one orseveral forms, such as: incorporation in the LARP, and FCRG; presentation in astaff technical position-or NUREG report; or as an NRC staff position. Thecriteria the task team established to identify regulatory and institutionaluncertainties to be reduced by guidance are as follows.

Guidance Category Criteria

- An uncertainty clarification can be derived from and be built upon adescription of the regulatory intent that is in the public record(e.g., statement of considerations or NUREG-0804) and clarificationcan be provided in a guidance document (e.g., staff position, FCRG,LARP, etc.).

- Because the existing wording of the rule satisfies the regulatoryintent of the Commission, a change in the rule itself is notrequired. The regulatory guidance, in the context of applicablestatutes and regulations and supporting background material (e.g.,NUREG-0804 or statement of considerations [for 10 CFR Part 60J), isa clear and implementable statement of the regulatory intent, takinginto account relevant prior agency practice.*

* In some cases, the regulatory language employs terms of artfamiliar to those affected by the rule. In such cases, the explicitrecognition in the rationale of applicable accepted practices and/orconventional scientific/engineering interpretation of the subject of theuncertainty would resolve the uncertainty, thereby eliminating the needfor uncertainty reduction. Also cases may exist where greater specificityin the regulatory language would result in excessively prescriptiveregulations that would unduly restrict the applicant's flexibility forcompliance and protection of health and safety. Specific design or siteconditions that may be encountered may require such flexibility.

Minor Rule Change

Uncertainty reduction may require only a minor revision of the regulation. Insuch cases, the task team has recommended appropriate language. A minor rulechange is in the nature of a minor correction, and those potential,uncertainties could be treated as a group in a single rulemaking action orappended to one of the Major Rule Change actions. To qualify as a minorrule change, the uncertainty must meet the criteria below.

Minor Rule Change Criteria

- The uncertainty is of the nature of an obsolete title or citation,a minor error, an inadvertent omission, or a similar minor problemin the text of the rule.

- It is desirable to correct the Identified problem.

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- The intended correction will not alter the existing regulatoryintent, and there is little risk that the perceived uncertaintywould lead to litigation.

Major Rule Change

In some cases, a need for future rulemaking will have been recognized anddocumented as, for example, In the case of the reserved 10 CFR Part 60, SubpartI, "Emergency Planning Criteria," or the EDO may have determined the need for arulemaking, or the EDO may have approved a recommendation based on an alternativeuncertainty reduction analysis. Accordingly, an appropriate category has beendesignated and a criterion established.

Major Rule Change Criterion

- The need for rulemaking has been documented by specific reservationin 10 CFR Part 60, or a notice of proposed rulemaking has beenissued, or the need for the rulemaking has been approved by the EDO.

Further Analysis

A determination of the method of reduction of uncertainties for the remainingitems will require further analysis and the development and documentation of acoordinated technical or policy (regulatory) basis for reduction. Moreover,the appropriate method for reduction and the specific regulatory method (staffposition, staff technical position, regulatory guide, or rulemaking, etc.)should not be developed or selected until the uncertainty has been analyzed, aregulatory or technical basis for its reduction has been developed, alternativereduction methods have been examined, and a technical or regulatory policyposition discussing the alternatives for reduction has been completed. Thecriterion for Further Analysis is:

Further Analysis Category Criterion

- Uncertainty reduction will require analysis and the development anddocumentation of a coordinated technical or policy (regulatory) basisfor reduction, if action is determined to be beneficial. Theappropriate method of reduction and the specific regulatoryinstrument (staff position, technical position, rulemaking, orregulatory guide, etc.) should not be developed or selected until:the uncertainty has been analyzed; alternative reduction methodsexamined; a regulatory and technical basis for Its reductiondeveloped; and a technical or policy position discussing thealternatives for reduction completed.

14

5. EVALUATION SUMMARY

Forty-nine regulatory and institutional uncertainties were previouslyidentified (Table 1 and Appendix A). Twenty-four are in the Guidance category,three are in the Minor Rule Change Category, seven are in the Major Rule ChangeCategory, and fifteen are in the Further Analysis Category.

The Guidance category has the largest number of uncertainty-reductionrecommendations, that is, the regulatory analysis concluded that for most ofthe regulatory and institutional uncertainties identified in 10 CFR Part 60,the staff considered the intent of the rule was clear, but there was arecognition that other parties might find additional information useful toavoid varying interpretations of the rule. The Further Analysis categoryhas the second largest number of uncertainty-reduction recommendations and is,perhaps, the tost significant, since it represents both an unresolved concernand an unresolved approach. The Minor Rule Change and Major Rule Changecategories have the least uncertainty-reduction recommendations.

5.1 Assessment of Potentially Adverse Conditions

The Center, in conducting the regulatory analysis of 10 CFR Part 60 for theNRC staff, identified a special group of uncertainties related to 10 CFR60.122(a)(2), potentially adverse conditions. The potential regulatoryuncertainties, which apply to all of the potentially adverse conditions, orare generally applicable to the potentially adverse conditions, occur in thefollowing phrases:

o "taking into account the degree of resolution" of the investigations(Uncertainty-Number 25);

o "not to affect significantly" (Uncertainty Number 26);

o "not likely to underestimate its effect" of the condition(Uncertainty Number 28);

o "adequately investigated" (Uncertainty Number 29);

o "adequately evaluated" (Uncertainty Number 27); and

o "geologic setting" (Uncertainty Number 24 and 30).

The Center considered that these phrases would have to be evaluated distinctfrom the performance objectives of 10 CFR 60.112 and 60.113 and that a regulatoryuncertainty occurred as a question of what, or how much, was needed todemonstrate compliance. The primary bases for the determination of potentialuncertainty were:

(1) a question of whether a Judgment of adequacy of an investigation isseparate from and a precursor to a judgment of reasonable assurance;

15

(2) a concern that the finding of reasonable assurance comes at the endof the licensing review process, and any judgment on adequacy wouldalmost certainly lead to delays;

(3) a concern that knowing that the performance objectives must be metmay not provide sufficient criteria for determining the operationalclarification of the regulatory uncertainties of 10 CFR 60.122; and

(4) a concern that the 10 CFR 60.101 references to site data, andpredictive models built from that data could be interpreted asrequiring 10 CFR 60.122 as a reasonable precursor to a finding ofreasonable assurance.

In relation to these concerns, the staff notes that the keystone of 10 CFR Part60 consists of the "performance objectives relating to isolation of the waste"that are set out in 10 CFR 60.112 (the overall performance objective) and 10 CFR60.113 (the NRC subsystem performance objectives). Section 60.122 mustnot be applied in isolation, but must be construed in the context of thoseprovisions. While an applicant is called upon to demonstrate that thesite and repository design satisfy the performance objectives, Section 60.122defines what the applicant must do and consider in performing this task. Itmust do so by demonstrating, first that the geologic setting exhibits anappropriate combination of favorable conditions so that together with theengineered barrier system, there is reasonable assurance that the performanceobjectives will be met (10 CFR 60.122(a)(1)) and, second, that if any of thespecified potentially adverse conditions are present, they will not compromisethe ability of the geologic repository to meet the performance objectivesrelated to the isolation of the waste (10 CFR 60.122(a)(2)).

This latter requirement--pertaining to the analysis of potentially adverseconditions--gives rise to several perceived regulatory uncertainties. Theperceived uncertainties concern what the applicant must do to demonstrate thatthe potentially adverse conditions will not compromise the ability of therepository to provide isolation. The regulation calls for the condition to be"adequately investigated." The regulation requires consideration of thepossible undetected presence of an adverse condition, "taking into account thedegree of resolution achieved by the investigations." Similarly, the effect ofthe adverse condition must be "adequately evaluated" using analyses which aresensitive to the condition and assumptions that "are not likely to underestimate"that effect. Finally, unless there are compensating favorable conditions orremedial measures, the applicant must show by these analyses that thepotentially adverse condition does not "affect significantly" the ability ofthe repository to meet the performance objectives.

In the Judgment of the staff, all of these issues should be addressed quitestraightforwardly. In each case the applicant must perform those investigationsand analyses that are needed to demonstrate (with reasonable assurance) that theperformance objectives related to isolation of the waste will be met. Thus, aninvestigation is adequate if such a demonstration can be made. The degree ofresolution is not prescribed, but there must be reasonable assurance that the

16

performance objectives are met taking that degree of resolution into account.The analyses must be sufficiently sensitive to the potentially adverseconditions, using assumptions that do not underestimate their effect, so thatthere is reasonable assurance that the performance objectives are met. Wherenecessary to show that the condition does not "affect significantly" therepository's performance, the applicant must demonstrate that notwithstandingits presence the performance objectives are met.

The generality with which the Commission discussed the provisions related toassessment of potentially adverse conditions is consistent with the staff'sunderstanding of the regulation. (Had the Commission intended some othercriteria to be applied, surely it would have provided some indication to thateffect.) Thus, in the statement of considerations accompanying its proposedrule, the Commission said only this:

;.. the technical criteria do identify site characteristics consideredfavorable for a repository as well as characteristics which, if present atthe site, may compromise site suitability and which will require carefulanalysis and such measures as may be necessary to compensate for themadequately. The impact of these characteristics on overall performancewould be site specific. Thus, the Commission has judged that these shouldnot be made absolute requirements. Presence of all the favorablecharacteristics does not lead to the conclusion that the site is suitableto host a repository. Neither is the presumption of unsuitability becauseof the presence of an unfavorable characteristic incontrovertible.Rather, the Commission's approach requires a sufficient combination ofconditions at the selected site to provide reasonable assurance that theperformance objectives will be achieved. If adverse conditions areidentified as being present, they must be thoroughly charaterized (sic)and analyzed and it must be demonstrated that the conditions arecompensated for by repository design or by favorable conditions in thegeologic setting. (46 FR 35280, 35284, July 8, 1981).

After public comment was considered, the Commission again discussed theprovisions setting out favorable and potentially adverse conditions and theanalysis thereof. As before, it seems clear that the Commission was mandatinganalysis oriented toward demonstrating, with reasonable assurance, that theperformance objectives were satisfied. The statement of considerations reads,in relevant part:

Although provisions relating to site characteristics have been revised,the Commission has retained the same two basic concepts. First, a siteshould exhibit an appropriate combination of favorable conditions, so asto encourage the selection of a site that is among the best thatreasonably can be found. By referring to a "combination" of conditions,It implies that the analysis must reflect the interactive nature ofgeologic systems. Second, any potentially adverse conditions should beassessed in order to assure that they will not compromise the ability ofthe geologic repository to meet the performance objectives. It is

17

I

important to recognize that a site is not disqualified as a result of thepotentially adverse condition. The Commission emphasizes this point herebecause several commenters who characterized the siting criteria as undulyrestrictive failed to appreciate that the presence of potentially adverseconditions would not exclude a site from further consideration whileothers mistakenly assumed that favorable conditions were requirements.(46 FR 28194, 28201, June 21, 1983).

It is also of interest to consider a change between a term in the proposed rule(which required certain demonstrations to show that potentially adverseconditions would "not impair significantly the ability of the geologicrepository to isolate the radioactive waste") and a term in the the final rule(which, in 10 CFR 60.122(a)(2), requires demonstrations that potentiallyadverse conditions will not "...compromise the performance of the geologicrepository"). The Commission explained, at 28211, that the change "is made toeliminate any questions regarding the difference between the two terms. Nosuch difference was intended. Both terms relate to conditions which wouldpotentially preclude the Commission from finding that the geologic repositorywould achieve the performance objectives."

Based on the above, the staff believes that the regulatory intent in relation tothe uncertainties appears clear. In determining compliance with the 10 CFR60.122 potentially adverse conditions, those requirements noted previously asuncertainties should be evaluated in relation to their effects on achieving theperformance objectives. For example, the investigation and evaluation mustbe adequate to support a finding, made with reasonable assurance, that theperformance objectives related to the isolation of the waste have been met.However, because the Center has expressed a strong contrary view, theseuncertainties (which the staff would otherwise have placed in the guidancecategory) are placed in the Further Analysis category.

5.2 Uncertainty Reduction Activities

Work is in place or planned to address most of the uncertainties in the MajorRule Change and Further Analysis uncertainty categories. Table 2 lists theuncertainties in the Major Rule Change and Further Analysis and correspondingplanned or ongoing tasks. Those items that are not presently scheduled taskswill be incorporated into the high-level waste program as part of the normalplanning and budgeting process. q

18

rW

TABLE 2

Tasks for Reducing Major Rule Change and Further

Uncertainty Abbreviated UncertaintyNumber Statement

4 Docketing Acceptance Criteria

15 Design radiation dose criteria

17, 21, 22

18

19

24, 30

25, 26, 27,28, 29

32, 33

34

7, 42

46

47

48

Anticipated and unanticipatedprocessess and events

Amendments to Part 60 toconform to EPA Standard

Substantially completecontainment

Clarification of "GeologicSetting"

Generally applicablePotentially Adverse Conditions

Meaning of "regional groundwaterflow system"

Sorption of radionuclides

Unpublished Subpart I

Engineered barrier systemrelease-rate limit

Reference to applicablemine-safety requirements

Criteria for containmentof greater-than-class-C

Analysis Uncertainties

Ongoing or PlannedTask

Development of FCRG

Repository OperationCriteria*

Conforming 10 CFR Part60 to the EPAStandard Rulemaking

Conforming 10 CFR Part60 to the EPA StandardRulemaking

Substantially completecontainment task

Task to be developed

NRC and Centerstaff analysis



Emergency PlanningCriteria Rulemaking

Gradual containmentrelease-rate task

Mining RegulationsTask

Future task subjectto DOE acting ondisposal approach

*Expanded from the former "Design Basis Accident" rulemaking

19

Those uncertainties which fall into the "Guidance Category" can mostappropriately be reduced through information placed in either the LARP or theFCRG. Should more immediate guidance be requested or required, the staff hasthe option of developing either staff positions or staff technical positions.However, as discussed in detail below, the task team did not Identify anyuncertainties that require immediate guidance at this time.

The NRC staff has determined that there are generally four types ofguidance documentation needed for the repository program: staff positions,staff technical positions, regulatory guides, and the License Application ReviewPlan. Each of these documents serves a different function in the High-LevelWaste Program. Although only regulatory guides and staff technical positionsare specifically issued as guidance or regulatory clarification for DOE, theother two types indirectly provide guidance to DOE.

While regulatory guides and staff technical positions provide guidance toDOE, the LARP and staff positions provide guidance to the NRC staff in itsreview of the DOE license application. The LARP will contain the reviewprocedures and acceptance criteria that the NRC staff will use to evaluate DOE'slicense application. The NRC staff issues staff positions to offer itsinterpretation of a specific requirement in 10 CFR Part 60, i.e., regulatoryinterpretive guidance. Because the NRC staff will use these two guidancedocuments in judging license application adequacy, DOE is advised to use themfor guidance as well.

The staff position is a useful mechanism to provide interpretive guidance for10 CFR Part 60. Accordingly, the task team considered preparing staffpositions as a possible follow-on uncertainty-reduction document activity forthe relatively straightforward uncertainties in the "Guidance" category. Todetermine the desirability of carrying a particular Appendix A uncertaintythrough a staff position development, the following criteria were applied

Staff Position Criteria

1. The uncertainty must be in "Guidance" category.

2. There must be a question of regulatory interpretation.

3. The question must be significant.

a. Have real potential or evidence for misinterpretation thatcould adversely affect the license-application preparation orreview, technical investigations, or conduct of the hearingprocess been identified?

b. Does the benefit Justify the resources required?

20

I

c. Is there a DOE or staff or other party request?

d. Does the topic require a timely resolution?

When the uncertainties were first presented there was a presumption that manyshould be addressed early and consideration was given to the use of staffpositions as interpretive guidance to document their reduction. Upon review ofthe uncertainties in the guidance category, the staff concluded they were notof sufficient significance such that DOE would need immediate guidance In thisarea. Therefore, the staff concluded that these uncertainties could moreappropriately be included in the development of the FCRG and LARP withoutimpacting DOE's program.

6. CONTINUED IDENTIFICATION OF UNCERTAINTIES

The task team's present scope has encompassed providing recommendations forreduction methods for regulatory and institutional uncertainties identified inCNWRA 90-003 and SECY 90-207. The staff may further identify potentialregulatory or institutional uncertainties. For example, there are a repositoryoperation criteria task and a-related SRA functional analysis task that arespecifically directed towards determing the need for additional regulatoryrequirements in 10 CFR Part 60. There will also be uncertainties identified byrecognition of regulatory misinterpretations arising from DOE documentation,onsite reviews, quality assurance and technical reviews, as well as byobservation and practices of NRC staff.

The task team assembled for this task was to review a previous effortspecifically directed at identifying regulatory and institutionaluncertainties. It is anticipated that task team efforts of this type will notbe required in the future, but that the approaches developed during this workwill be used, along with SRA procedures, to process uncertainties on anindividual basis. The SRA PASS data base has provisions for maintaining anuncertainty identification and resolution record and will serve until theuncertainty resolution is documented.

21

7. REFERENCES

1. R.F. Weiner and W.C. Patrick, Center for Nuclear Waste Regulatory Analyses,"Analysis and Evaluation of Regulatory Uncertainties in 10 CFR 60 SubpartsB and E," CNWRA 89-003, May 1989.

2. R.F. Weiner, W.C. Patrick, "Identification and Evaluation of Regulatoryand Institutional Uncertainties in 10 CFR Part 60", CNWRA 90-003, February1990.

3. U.S. Nuclear Regulatory Commission, "Regulatory Strategy and Schedules forthe High-Level Waste Repository Program," SECY-88-285, October 5, 1988.

4. U.S. Nuclear Regulatory Commission,"First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program," SECY90-207, June 7, 1990.

5. Center for Nuclear Waste Regulatory Analyses, Technical OperatingProcedure, "Program Architecture Relational Database Content andDevelopment Instructions," TOP-001-02, August 31, 1989.

22

a

APPENDIX A

23

APPENDIX A

REGULATORY AND INSTITUTIONAL UNCERTAINTY REDUCTION

UNCERTAINTY NUMBER: 1 (Page B-1, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Information Having Significant Implications

CITATION: 10 CFR 60.10(b)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "significant implications"needs clarification in relation to the fields of public health and safety,and common defense and security. Clarification or definition will avoid-unnecessary action by DOE in minor matters and will ensure proper action'for those matters of importance that satisfy the regulatory intent of theCommission.

RECOMMENDED RESOLUTION APPROACH: Guidance

The standard for reporting refers to the licensee's own recognition ofinformation with significant implications for health or safety or commondefense or security.

RECOMMENDATION RATIONALE: Paragraph (b) of 10 CFR 60.10 reads:

"Each applicant or licensee shall notify the Commission ofinformation identified by the applicant or licensee as having for theregulated activity a significant implication for public health andsafety or common defense and security. An applicant or licenseeviolates this paragraph only if the applicant or licensee fails tonotify the Commission of information that the applicant or licenseehas identified as having a significant implication for public healthand safety or common defense and security...."

Section 60.10(b) was added to the Commission's regulations as part of arulemaking that addressed the need for the Nuclear Regulatory Commission(NRC) to receive complete, accurate, and timely communications from all ofits licensees and license applicants. Thus, in addition toltsapplication to geologic repositories, Its counterparts can be found Inthose portions of NRC's regulations that apply to other material andfacility licensees, as well.

REGULATORY AND INSTITUTIONAL UNCERTAINTIES APPENDIX A

2

As a matter of fact, the Issue raised by the Center for Nuclear WasteRegulatory Analyses is one that was specifically addressed by theCommission when it adopted the regulations In question. Commenters on theproposed rule, which would require applicants and licensees to notify theCommission of information they have Identified as having a significantimplication for public health and safety, or common defense and security,indicated that further clarification of what is "significant' would bedesirable. The Commission's response to 52 FR 49363, December 31, 1987,was as follows:

"The Commission believes that the requirements of proposed paragraph(b) are sufficiently clear that that licensees will be able todetermine when reporting is required. The standard for reporting isnot so broad that licensees will have difficulty recognizing it.For example the rule does not require licensees to predict what theNRC will likely deem to be "material" information, an arguably vaguestandard; rather the standard is one of a licensee's own recognitionof information with significant health or safety or common defense orsecurity implications. This is a standard that the Commission shouldreasonably expect licensees to understand and apply. Moreover thenotice of proposed rulemaking gives guidance, in the form ofexamples, as to what could indicate recognition by licensees of thesignificance of the information. As noted in VEPCO, no specific setof regulations can be expected to cover all possible circumstances;within this constraint the Commission believes the requirements ofparagraph (b) are clearly set forth."

The examples set out in the notice of proposed rulemaking, as herereferred to by the Commission, observed that "...an applicant's orlicensee's recognition of information as significant could be establishedby the fact that specific meetings were held to discuss the matter,analyses performed or other internal actions taken to evaluate thematter." 52 FR 7432, December 31, 1987.

P. M. Altomare, NRC/NMSS, 01/29/91

REFERENCES FOR RATIONALE:

1. 10 CFR Part 60, 'Disposal of High-Level Radioactive Wastes in GeologicalRepositories.'

2. Center for Nuclear Waste Regulatory Analyses, "Identification andEvaluation of Regulatory and Institutional Uncertainties in lb CFR Part60," CNWRA 90-003, February 28, 1990.

3. 52 FR 49363 (December 31, 1987).

4. 52 FR 7432 (March 11, 1987).


3


UNCERTAINTY TITLE: Environmental Report vs. Environmental ImpactStatement

CITATION: 10 CFR 60.23

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: 10 CFR 60.23 uses the termsKenvironmental report' and "Site Characterization Report," which isinconsistent with Nuclear Waste Policy Act (NWPA) and with other July 3,1989, changes to lD CFR Part 60. It should be made clear that these termsare intended to be "environmental impact statement" and "SiteCharacterization Plan," respectively.

RECOMMENDED RESOLUTION APPROACH: Minor Rule Change

Revise 10 CFR 60.23 to read: "In submissions made pursuant to this part,DOE may Incorporate by reference information contained in previousapplications, statements, or reports filed with the Commission."

RECOMMENDATION RATIONALE: 10 CFR Part 60 was amended in 1989 so as to providefor The Department of Energy's (DOE's) submission of its EnvironmentalImpact Statement (EIS) in lieu of the environmental report hitherto calledfor by the regulations. Inadvertently, one reference to an "environmentalreport" was not amended. The proposed resolution corrects this situationby allowing incorporation by reference for all DOE submissions (whichwould include the EIS).

J. Wolf, NRC/OGC, 11/27/90


1. 10 CFR Part 60, "Disposal of High-Level Radioactive Wastes in GeologicalRepositories."

2. Center for Nuclear Waste Regulatory Analyses, "Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60," CNWRA 90-003, February 28, 1990.

3. U.S. Nuclear Regulatory Commission, "NEPA Review Procedures forHigh-Level Waste," 54 FR 27864 (July 3, 1989).


. *

4

UNCERTAINTY NUMBER: 3 (Page E-7, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Detailed Content of Application Not in 10 CFR 60.21


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: Although 10 CFR 60.21 describesgeneral requirements for what should be included in the generalinformation and Safety Analysis Report in the license application, moredetailed guidance Is required so that DOE can prepare a completeapplication.


A draft "Format and Content Guide for the Licensing Application for theHigh-Level Waste Repository," DG-3003, which provides detailed genericlicense application guidance, was published November 1, 1990.

RECOMMENDATION RATIONALE: Preparation of a License Application Format andContent Guide for a high-level radioactive waste repository is planned(see SECY 90-207), and a draft for public review and comment was publishedNovember 1990.

No further regulatory action, other than the completion of this regulatoryguide, will be necessary to resolve this uncertainty.

P. Altomare, NRC/NMSS, 01/29/91



2. Center for Nuclear Waste Regulatory Analyses, 'Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60," CNWRA 90-003, February 28, 1990.

3. Nuclear Regulatory Commission, "Format and Content for the LicenseApplication for the High-Level Waste Repository," DG-3003, November 1990.


5

UNCERTAINTY NUMBER: 4 (Page B-8, Appendix E, CNWRA 90-003)

UNCERTAINTY TITLE: Criteria Used to Accept the License Application forDocketing

CITATION: 10 CFR 60.24(a)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: It is uncertain whether 10 CFRPart 60 and other regulations adequately describe the means used toqualify a license application for docketing. Adequate criteria are neededby both DOE and NRC to determine the acceptability of the application fordocketing.

RECOMMENDED RESOLUTION APPROACH: Further Analysis

Further analysis is required to determine the need for high-level waste(HLW) repository license application acceptance criteria other than thatto be provided in the HLW Repository License Application Format andContent Guide.

RECOMMENDATION RATIONALE: In SECY 89-339, it was noted that "Developingcriteria for acceptance of the License Application will provide adocumented basis on which to accept or reject the License Application.""Acceptance criteria might also improve the effectiveness of prelicensingconsultation and the Site Characterization Plan (SCP) Progress Reportreview process by encouraging DOE to resolve NRC staff concerns before theLicense Application Is submitted." In SECY 90-207, "First Update of theRegulatory Strategy and Schedules for the High-Level Waste RepositoryProgram," developing license application docketing criteria and content isIdentified as an activity for reducing regulatory uncertainty.

The Draft Regulatory Guide DG-3003, "Format and Content for the LicenseApplication for the High-Level Waste Repository," November 1990, includesSection 1.6.2, "Status of DOE Resolution of NRC Objections to LicenseApplication Submittal." This section provides guidance to the Departmentof Energy (DOE) on specific information to be provided for the NuclearRegulatory Commission (NRC) to reach a decision on docketing the LicenseApplication (LA). For example,

"Therefore, as part of the acceptance review of the LA and before adecision on docketing the LA, the NRC staff will evaluate the effectof any unresolved objection to LA submittal, both individually and incombination with others, on the NRC staff's ability to conduct ameaningful review and make a decision regarding constructionauthorization within the three-year statutory time period."

NRC staff will review public comments on this proposed regulatory guidance,in determining the need for further action on this uncertainty.

This uncertainty will be evaluated, after public comments, to determine anyrevisions to the Draft Regulatory Guide, and toprepare acceptance criteria for the License Application Review Plan.



* * . *

6




3. Nuclear Regulatory Commission "Format and Content for the LicenseApplication for the High-Level Waste Repository," DG-3003, November 1990.

4. Nuclear Regulatory Commission "Regulatory Strategy and Schedules for theHigh-Level Waste Repository Program," SECY 88-285, October 1988.

5. Nuclear Regulatory Commission "Regulatory Strategy for the High-LevelWaste Repository Program: Description of Uncertainties Being Addressed bythe U. S. Nuclear Regulatory Commission Staff," SECY 89-339,October 31, 1989.

6. Nuclear Regulatory Commission "First Update of the Regulatory Strategyand Schedules for the High-Level Waste Repository Program," SECY 90-207,June 7, 1990.


7

UNCERTAINTY NUMBER: S (Page B-10, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Responsibility for Public Document Room

CITATION: 10 CFR 60.22(d)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: As presently written, iD CFR60.22(d), when taken in the context of the balance of 60.22, can beinterpreted to require DOE to be responsible for the contents of an NRCpublic document room. The intent of the regulation needs to be clarified.


1. Revise 10 CFR 60.22(d) to read: "At the time of filing of anapplication and any amendments thereto, DOE shall make one copyavailable in an appropriate location near the proposed geologicrepository operations area for inspection by the public. DOE shallmake the environmental impact statement and any supplements theretoavailable in the same manner. If the Commission has established apublic document room at such a location, DOE shall comply with thisparagraph by filing the specified documents as provided in paragraph(b). 1

2. Insert a new 10 CFR 60.22(e) to read: "DOE shall produce an updatedcopy of the application, and the environmental impact statement andsupplements at any public hearing held by the Commission on theapplication, for use by any party to the proceeding."

3. Redesignate 10 CFR 60.22(e) as new 60.22(f) and revise the phrase"paragraphs (c) and (d)" to read "paragraphs (c) and (e)."

RECOMMENDATION RATIONALE: The amended language would make it clear that if aNuclear Regulatory Commission (NRC) public document room is established,the Department of Energy's (DOE's) responsibility extends only toproviding the required documents (which would thereafter be theresponsibility of NRC, as documents custodian).

The language would also make it clear, however, that there is a second,independent requirement -- for DOE to produce updated documents at publichearings. Separating this from the Public Document Room-deposit provisionwill express the requirements more clearly.

J. Wolf, NRC/OGC, 11/27/90. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~..


l. 10 CFR Part 60, "Disposal of High-Level Radioactive Wastes inGeological Repositories."

2. Center for Nuclear Waste Regulatory Analyses, uIdentification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60," CNWRA 90-003, February 28, 1990.


8

UNCERTAINTY NUMBER: 6 (Page B-12, Appendix B. CNWRA 9O-003)

UNCERTAINTY TITLE: Consideration of Performance Confirmation duringConstruction Authorization


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The intent of NRC needs to beclarified relative to the review and/or approval of the performanceconfirmation program (Subpart F of 10 CFR 60) to be performed during theconstruction phase. Performance confirmation should be considered as apart of the construction authorization process to maintain consistencywithin 10 CFR 60.31(a) (which references consideration of the programsand/or plans of Subparts E,G, H, and I) and to provide consistency withSubpart F (in particular, 10 CFR 60.140). Approval of the plannedPerformance Confirmation Program should be an aspect of NRC'sconsiderations to authorize construction.


1. Redesignate 10 CFR 60.21(c)(14) as 10 CFR 60.21(c)(14)(i).

2. Add a new 10 CFR 60.21(c)(14)(ii), to read, "A description of theperformance confirmation program."

RECOMMENDATION RATIONALE: The regulations require the Department of Energy(DOE) to perform, or permit the Commission to perform, a performanceconfirmation program in accordance with Subpart F (10 CFR 60.74). To theextent the Commission finds it necessary, the construction authorizationwill include conditions further defining the performance confirmationrequirements (10 CFR 60.32).

However, the contents of the application section (10 CFR 60.21) contains noexplicit provision for DOE to describe the performance confirmationprogram that it proposes to undertake. Such Information is important tothe Commission both substantively (helping to provide reasonable assuranceof protection of health and safety) and procedurally (helping in theformulation of appropriate license conditions).


REFERENCES FC.; RATIONALE:

1. 10 CFR Part 60, 'Disposal of High-Level Radioactive Wastes in GeologicalRepositories."



9


UNCERTAINTY TITLE: Unpublished Subpart I in 10 CFR Part 60

CITATION: 10 CFR 60.31(a)(5)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: 10 CFR 60.31(a)(5) requires theCommission to determine that DOE's emergency plan complies with thecriteria of Subpart I, a reserved (unpublished) Subpart in 10 CFR Part 60.Subpart I needs to be published in order to provide emergency plancriteria.

RECOMMENDED RESOLUTION APPROACH: Major Rule Change

The Commission plans to initiate rulemaking to establish emergencyplanning criteria under Subpart I in 10 CFR Part 60.

RECOMMENDATION RATIONALE: The reserved Subpart I, "Emergency PlanningCriteria," is intended to resolve this uncertainty when completed.Because 10 CFR 60.31(a)(5) requires the Department of Energy's (DOE's)emergency plan to be in compliance with 10 CFR Part 60, Subpart I, at thetime a Construction Authorization is issued, DOE must know the NuclearRegulatory Commission's (NRC's) "Emergency Planning Criteria," to preparethe License Application. A policy and technical basis for the intendedrulemaking will be developed and rulemaking undertaken as set forth inSECY 90-207.



1. 10 CFR Part 60, "Disposal of High-Level Radioactive Waste in GeologicalRepositories."



10


UNCERTAINTY TITLE: Clarify "Substantially increasing retrievaldifficulty"


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: There appears to be an Inconsistencybetween the phrase "substantially increase the difficulty of retrievingsuch emplaced waste..." in 10 CFR 60.46(a)(1) and the intent of 10 CFR60.111(b), as expressed in NUREG-0804. This apparent inconsistency mayplace an unnecessary regulatory burden on both NRC and DOE in that itwould require license amendments under 60.46(a)(1) for changes which"substantially Increase the difficulty of retrieving" while the basicrequirement of 60.111(b) is only that retrieval be possible.


The existing requirement is appropriate since it ensures that actionsaffecting retrievability are reviewed by the Nuclear Regulatory Commission(NRC) before irreversible steps are taken by the Department of Energy(DOE).

RECOMMENDATION RATIONALE: Actions that "... substantially increase thedifficulty of retrieving" waste encompass a range of actions that might beundertaken without precluding waste retrieval. However, this does notrepresent any inconsistency with 10 CFR 60.111(b) or other provisions ofPart 60. The objective of 10 CFR 60.46(a) Is to ensure that the Judgmentas to whether such action should be undertaken is not made unilaterally byDOE. Rather, DOE must describe its intended action to the Commission(under 10 CFR 60.46(b)), which will be guided by the considerations thatgovern the issuance of the initial license. Accordingly, the DOEsubmission is to be Judged by the same performance objectives as set outin 10 CFR 60.111(b), 60.112, and 60.113, and if the action is acceptableunder that standard, an amendment will be issued.

Nalem Tanious, NRC/NMSS, 01/28/91




3. Nuclear Regulatory Commission, "Staff Analysis of Public Comments onProposed Rule 10 CFR 60, Disposal of High-Level Radioactive Wastes inGeologic Repositories," NUREG-0804, December 1983.


11


UNCERTAINTY TITLE: Compliance Demonstration/DeterminationRegarding Human Intruders and RecordArchiving

CITATION: 10 CFR 60.51(a)(2)(il)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: In the absence of specific criteria,the phrase 'that would likely be consulted by potential human intruders"does not lend itself to explicit definition and requires clarification sothat realistic archiving can be accomplished.


Archives that are likely to be consulted by potential human intruders areto be identified in the license amendment for permanent closure and shouldbe commensurate with the state of knowledge and data-handling technology.

RECOMMENDED RATIONALE: 10 CFR 60.51(a) calls for the Department of Energy (DOE)to submit an updated license application, before permanent closure, that isto include a detailed description of the measures to be employed to regulateor prevent activities that could Impair the long-term isolation of emplacedwaste within the geologic repository and to ensure that relevant informationwill be preserved for the use of future generations. It is in that contextthat the regulations require placement of records in archives and land recordsystems that would be likely to be consulted by potential human intruders.

There are good reasons why the regulations are not more specific. In the firstplace, the appropriate data repositories are not to be defined until the timeof permanent closure. This Is several decades away, and it is not practicableto identify just what the appropriate archives and record systems will be.Second, the appropriate location for such records is, to some degree, dependenton the specific site of the geologic repository. If, for example, thegeologic setting is characterized by the presence of certain economic mineralsor by the occurrence of peculiar seismic phenomena, the appropriate archivesmight include those that relate to the minerals or phenomena that are or may bepresent. Third, the regulations clearly articulate the policy framework bywhich the adequacy of the archive and record systems is to be Judged -- namely,the regulation or prevention of activities that could impair long-termisolation.





3. 48 FR 28194 (June 21, 1983).


12


UNCERTAINTY TITLE: "Construction problems" Need Clarification

CITATION: 10 CFR 60.72(b)(6)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "construction problems"requires further definition in order to ensure documentation of all thoseproblems of interest to the Commission, and to clearly identifyappropriate recordkeeping requirements for DOE.


The 'construction problems" are those that need to be documented to ensurethe long-term information availability to future generations to provide abasis for regulating or preventing activities that may be detrimental tolong-term isolation of waste.

RECOMMENDATION RATIONALE: The term "construction problems" is adequatelydefined by its context. That is, the "construction problems" at issue is-- as stated in the introductory text of 10 CFR 60.72(b) -- in one ofeleven categories for which records are ". ..required under paragraph (a)."This means, In turn, that the construction problems that must bedocumented are those that pertain to "usability for future generations inaccordance with 10 CFR 60.51(a)(2)." The latter reference requires theDepartment of Energy (DOE), before permanent closure, to update itslicense application so as to include a detailed description of measures tobe employed to ensure that relevant information will be preserved forfuture generations. Accordingly, if the construction problems arerelevant to future generations -- particularly, as stated in 10 CFR60.51(a)(2), for the purpose of regulating or preventing activities thatcould impair the long-term isolation of emplaced waste -- then they fallwithin the scope of 10 CFR 60.72(b). Other construction problems may alsobe of interest, and may need to be documented as part of DOE's qualityassurance program or pursuant to a condition of the constructionauthorization (see 10 CFR 60.31(b)(1)), but they are not addressed by 10CFR 60.72(b).




2. Center for Nuclear Waste Regulatory Analyses , 'Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60," CNWRA 90-003, February 28, 1990.


13


UNCERTAINTY TITLE: "Anomalous conditions" Need Clarification


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "anomalous conditions"requires further definition in order to ensure documentation of all thoseconditions of Interest to the Commission, and to clearly identifyappropriate recordkeeping requirements for DOE.


The "anomalous conditions" are those that need to be documented to ensurelong-term Information availability to future generations.

RECOMMENDATION RATIONALE:

The "anomalous conditions" are those that are relevant "...to regulate orprevent activities that could impair the long-term isolation of emplacedwaste within the geologic repository and to assure that relevant infor-mation will be preserved for the use of future generations" (10 CFR 60.51(a)(2)). "Anomolous conditions" is one of eleven categories in 10 CFR60.72(b) for which construction records must be kept. For a fulleranalysis of the provisions of 10 CFR 60.72(b), and their relationship toother provisions of 10 CFR Part 60, see the discussion of Uncertainty 10.





REGULATORY AND INSTITUTIONAL UNCERTAINTIES .APPENDIX A

14

UNCERTAINTY NUMBER: 12 (page B-30, Appendix 8, CNWRA 90-003)

UNCERTAINTY TITLE: Substantial Safety Hazard


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "substantial safety hazard"requires further definition in regard to the characteristics of the siteand the design and construction of the geologic repository operationsarea. More specific guidance is needed to ensure that those hazardsreported by DOE satisfy the regulatory intent of the Commission.


'Substantial safety hazard" is defined as a loss of safety function to theextent that there is a major reduction in the degree of protectionprovided to public health and safety.

RECOMMENDATION RATIONALE: Section 206 of the Energy Reorganization Act of1974, U.S.C. 5846, imposed upon certain parties an obligation to notifythe Nuclear Regulatory Commission (NRC) of defects that "...could create asubstantial safety hazard, as defined by regulations which the Commissionshall promulgate."

In Implementing this provision, the Commission defined the term"substantial safety hazard" (in 10 CFR 21.3(k)) to refer to a "...loss ofsafety function to the extent that there is a major reduction in thedegree of protection provided to public health and safety...."

The Commission's statement of considerations, accompanying thepromulgation of the rule (42 FR 28801, June 6, 1977), expressly declaredthat "...insufficient experience has been accumulated to permit thewriting of a detailed regulation at this time that would provide a precisecorrelation of all factors pertinent to the question of what is asignificant safety hazard." Rather, the Commission identified certaincriteria that it indicated to be "...appropriate for determination ofcreation of a substantial safety hazard" -- namely:

- Moderate exposure to, or release of, licensed material;

- Major degradation of essential safety-related equipment; and

- Major deficiencies involving design, construction, insfection,test, or use of licensed facilities or material.

In view of this policy direction from the Commission, the staff regardsthe existing regulation to provide an adequate basis for determiningcompliance. However, as the Commission indicated when it issued the rule,"...additional guidance in the form of regulatory guides may be developedshould experience with the application of Part 21 indicate the need for


15

such guidance." Such experience would be derived from ongoing activitieslicensed under other parts of NRC regulations and would be applied to ageologic repository, as appropriate.

Robert Neel, NRC/NMSS, 01/23/91James Wolf, NRC/OGC, 01/23/91





16


UNCERTAINTY TITLE: Significant Deviation

CITATION: 10 CFR 60.73(b)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "significant deviation"requires further definition in regard to "design criteria and design basesstated in the application." More specific guidance will ensure that thosedeviations reported by DOE satisfy the regulatory intent of theCommission.


The reporting requirements will be clarified in the License ApplicationFormat and Content Guide and License Application Review Plan and may bespecified as appropriate by provision of the construction authorization,as described in 10 CFR 60.32(b).

RECOMMENDATION RATIONALE: The term "significant deviation" is not unique to 10CFR Part 60. On the contrary, in similar context, a holder of a constructionpermit is required to notify the Commission of every deficiency found, indesign and construction, that could adversely affect the safe operation of anuclear power plant and that represents, inter alia:

"...a significant deviation from performance specifications which willrequire extensive evaluation, extensive redesign, or extensive repair toestablish the adequacy of a structure, system, or component to meet thecriteria and bases stated in the safety analysis report or constructionpermit or to otherwise establish the adequacy of the structure, system, orcomponent to perform its intended safety function." (10 CFR50.55(e)(1)(iv)).

The requirement in 10 CFR 60.73 -- that the Department of Energy (DOE) is topromptly notify the Commission of each deficiency that represents "...asignificant deviation from the design criteria and design bases stated in theapplication..." -- does not stand alone. It must be read in conjunction with10 CFR 60.32(b), which, among other things, states that "The Commission willincorporate, In the construction authorization, provisions requiring DOE tofurnish periodic or special reports regarding...(2) any data about the siteobtained during construction which are not within the predicted limits uponwhich the facility design was based, (3) any deficiencies in design andconstruction which, if uncorrected, could adversely affect safety at any futuretime...." Thus, there is in place a mechanism to specify the conditions thatwould call for reports to be filed during construction, pursuant to 10 CFR60.73. There may be a need to be more specific regarding matters that might


17

need to be reported once a license to receive and possess waste has beenissued; but, these might be handled by license conditions and, In any event,there is no compelling need to address the matter for many years to come.

Robert Neel, NRC/NMSS, 01/23/91James Wolf, NRC/OGC, 01/23/91



2. Center for Nuclear Waste Regulatory Analyses, "Identificat1on andEvaluation of Regulatory and Institutional Uncertainties in 10 CFRPart 60," CNWRA 90-003, February 28, 1990.


I I - I .

18

UNCERTAINTY NUMBER:

UNCERTAINTY TITLE:

CITATION:

14 (Page B-38, Appendix B, CNWRA 90-003)

Reference Clarification

10 CFR 60.111(a)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: Criteria are needed to determine thelowest level of referenced regulations which are to be incorporated inorder to determine the extent of applicability of referenced regulations.


All regulations in 10 CFR Part 20, as referenced in 10 CFR 60.111(a), mustbe considered applicable to a geologic repository.

RECOMMENDATION RATIONALE: With respect to 10 CFR Part 20, it is clear that allprovisions of the regulation apply. This is expressly stated in the scopeprovisions of that part, which reads as follows:

"The regulations in this part apply to all persons who receive,possess, use or transfer material licensed pursuant to theregulations in Parts 30 through 35, 39, 40, 60, 61, 70 or 72 ofthis chapter, Including persons licensed to operate a productionor utilization facility pursuant to Part SD of this Chapter."

The staff also considers references to applicable EnvironmentaAgency standards to be clear. See also Uncertainty 18.

1 Protection




2. Center forEvaluation60," CNWRA

Nuclear Waste Regulatory Analyses, "Identification andof Regulatory and Institutional Uncertainties in 10 CFR Part90-003, February 28, 1990.



UNCERTAINTY TITLE: Design Radiation Dose Criteria

CITATION: 10 CFR 60.111(a)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: Regulations referenced by 10 CFR60.111(a) provide different radiation dose criteria for both normaloperations and accidents. These differences need to be reconciled toprovide clear performance objectives for both conditions.


Although there is no Nuclear Regulatory Commission (NRC) precedent forspecifying a dose criterion for accidents (Design Basis Accident), NRC isinvestigating the requirement for a separate site-suitability dosecriterion for a geologic repository operations area.

RECOMMENDATION RATIONALE: As is the case with NRC regulations for-othertypes of facilities, no separate dose criterion is specified foraccidents. Although regulations for some facilities (i.e., those licensedunder 10 CFR Part 50 and 10 CFR Part 72) have dose criteria for sitesuitability (which are determined by assuming serious or major designbasis accidents), neither 10 CFR Part 20 nor 10 CFR Part 60 contains suchcriteria. However, on April 19, 1990, the Department of Energy (DOE)filed a petition for rulemaking requesting that NRC amend 10 CFR Part 60to include quantitative accident dose criteria. DOE believes thatspecific accident dose criteria are necessary to reduce perceiveduncertainties in the current regulation and to provide specific guidancefor the protection of public health and safety. The subject matter ofthis DOE petition relates closely to the rulemaking actions, underconsideration by NRC, published in the NRC Regulatory Agenda (NUREG-0936,Vol. 8, No. 4, January 1990). Although 10 CFR Part 60 does not presentlyhave a controlled area requirement like the one in 10 CFR Part 72 -- that is,one that pertains to the operating lifetime of the facility -- the NRC staffis addressing the need and appropriateness of such a requirement both onits own initiative and in response to the pending petition for rulemakingfrom DOE.

Jerome Pearring, NRC/NMSS, 03/06/91Seth Coplan, NRC/NMSS, 03/06/91



2. Center for Nuclear Waste Regulatory Analyses, 'Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFRPart 60," CNWRA 90-003, February 28, 1990.

3. The Nuclear Regulatory Commission, NUREG-0936, NRC Regulatory Agenda,Volume 8, No. 4, January 1990.


' ...

20

UNCERTAINTY NUMBER: 16 (Page B-43. Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: "'Facilitate" Versus "Not Prevent" Waste Retrieval

CITATION: 10 CFR 60.111(b)(l)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The NRC intent needs to be clarifiedas to whether the geologic repository is to be designed to facilitatewaste retrieval, or only that the design must not preclude waste retrieval(i.e., not make retrieval impossible). DOE needs guidance regarding whatdesign action, if any, is intended by the regulation, particularly withrespect to the waste package and its handling equipment, in order torespond with an acceptable design and to permit NRC to evaluate the DOEcompilance demonstration effectively.


The design objective is to accommodate necessary measures shouldretrieval prove to be needed.

RECOMMENDATION RATIONALE: This perceived uncertainty pertains to a number ofdesign criteria that refer to potential retrieval of waste. The questionpresented is whether these design criteria should be interpreted actuallyto facilitate waste retrieval or merely to accommodate necessary measures,should retrieval prove to be needed.

In the staff's view, the requirements must be viewed in the sense statedin 10 CFR 60.131, which defines the scope of all the design criteria.Those design criteria are meant to be minimum safety features "...neededto achieve the performance objectives." The pertinent performanceobjective, of course, is (as stated in 10 CFR 60.111(b)) to "...preservethe option of waste retrieval..." during the preclosure phase. The designcriteria should be construed in a manner that is consistent with theperformance objectives, and, as the Commission made clear, are intended torequire a design that does not make retrieval impracticable, but there isno requirement that retrieval be otherwise facilitated. Thus, in issuingits technical criteria, the Commission indicated its concern "...thatretrievability requirements not unnecessarily complicate or dominaterepository design." Further, the Commission, in discussing the definitionof "retrieval," added to the final rule, declared that the retrievabilityrequirement "...does not imply ready or easy access to emplaced waste --the idea is that it should not be made impossible or impractical toretrieve the wastes if such retrieval turns out to be necessary to protectthe public health and safety" (48 FR 28197). As noted in 10 CFR 60.111(b)(3),"...a reasonable schedule for retrieval is one that would permit retrievalin about the same time as that devoted to construction of the geologicrepository operations area and the emplacements of wastes."





c -- i - 8 S.

21

2. Center for Nuclear Waste Regulatory Analyses, "Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFRPart 60," CNWRA 90-003, February 28, 1990.

3. 42 USC 10101, "The Nuclear Waste Policy Act of 1982."

4. 48 FR 28197 (June 21, 1983).


22


UNCERTAINTY TITLE: Anticipated and Unanticipated Processes and Events


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The terms "anticipated processes andevents" and "unanticipated processes and events" require furtherdefinition to permit uniform interpretation of the regulatory requirement.


This uncertainty is scheduled to be resolved in the rulemaking conforming10 CFR Part 60 to the final Environmental Protection Agency (EPA)Standard.

RECOMMENDATION RATIONALE: As defined within 10 CFR 60.2, the terms"anticipated processes and events" and "unanticipated processes andevents" are two categories of processes and events that could occur withinthe "geologic setting" during the period following permanent closure ofthe geologic repository. Determination of these categories of processesand events is required because:

(1) 'Anticipated processes and events" are the primary design basisprocesses and events for the design of the waste package and engineeredbarrier system; and

(2) "Anticipated processes and events," together with "unanticipatedprocesses and events," are to form the basis for analysis to determinecompliance with the overall system performance objectives of 10 CFR Part60.

It therefore cannot be determined if the natural barriers, waste package,or engineered barrier system will comply with the performance objectivesof 10 CFR Part 60 until the "anticipated processes and events" and"unanticipated processes and events" have been determined.

The Nuclear Regulatory Commission (NRC) staff has recognized theuncertainty that is contained within these phrases and as a result hasincluded these terms in the strategy for rulemaking (see SECY 88-285 andSECY 90-207). This series of uncertainties was originally addressed inthe draft "Generic Technical Position (GTP) on Guidance for Determinationof Anticipated Processes and Events and Unanticipated Processes andEvents' (see 53 FR 6040). Following public comment on this draft GTP, itwas determined that it was in the best interest of this program to dealwith this uncertainty in the rulemaking to conform 10 CFR Part 60 to theEnvironmental Protection Agency (EPA) Standard, to ensure a correlationbetween the NRC terms "anticipated processes and events," and "unanticipated processes and events" and the EPA terms "undisturbed


ft . l

23

performance" and "all significant processes and events."has been meeting with the EPA staff with the expectationcan be resolved In the final EPA Standard, so that thereterminology within the two rules.

The NRC staffthat this concernis a common

J. S. Trapp, NRC/NMSS, 01/11/91


1. U.S. Nuclear Regulatory Commission, 'Regulatory Strategy and Schedulesfor the High-Level Waste Repository Program," SECY-88-285, October 1988.

2. U.S. NuclearStrategy andSECY-90-207,

Regulatory Commission, "First Update of the RegulatorySchedules for the High-Level Waste Repository Program,"June 1990.

3. U.S. Nuclear Regulatory Commission, "Notice of Availability:Availability of Draft Generic Technical Position on 'Guidance forDetermination of Anticipated Processes and Events and UnanticipatedProcesses and Events,"' 53 FR 6040, February 29, 1988.


24

UNCERTAINTY NUMBER: I8 (Page B-51, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Amendments to 10 CFR 60.112 to Conform to EPAStandard


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: It is uncertain what amendments willhave to be made to 10 CFR 60.112 to conform to the forthcoming revision ofthe EPA Standard, 40 CFR Part 191. Since 10 CFR 60.112 refers toconformance to EPA Standards, any changes in those standards must beaddressed to assure that performance objectives of 10 CFR 60.112 are met.


The uncertainty will be resolved in rulemaking conforming 10 CFR Part 60to the final Environmental Protection Agency (EPA) Standard.

RECOMMENDATION RATIONALE: The Commission has recognized the uncertainty thatIs contained within 10 CFR Part 60, due to the need to conform the rule toincorporate the finalized EPA standard. During the promulgation of thefinal rule, the Commission stated;

"The Commission will review these criteria after EPA's environmentalstandards are published in final form and will initiate subsequentrulemaking actions, as necessary, to take such standards Into account."(48 FR 28195)

Before the EPA Standard was remanded by the courts, the Nuclear RegulatoryCommission (NRC) had initiated rulemaking to conform to the EPA standard(see 51 FR 22288); however, this action was put in abeyance until thefinal standards are again published.

The need for this action has also been presented in SECY 88-285 and SECY90-207.

J. S. Trapp, NRC, NMSS, 01/11/91


1. U.S. Nuclear Regulatory Commission, "Regulatory Strategy and Schedulesfor the High-Level Waste Repository Program," SECY-88-285, October 6,1988.

2. U.S. Nuclear Regulatory Commission, 'First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program,"SECY-90-207, June' 1990.


25

3. U.S. Nuclear Regulatory Commission, 'Disposal of High-Level RadioactiveWastes in Geologic Repositories, Technical Criteria," 48 FR 28195(June 21, 1983).

4. U.S. Nuclear Regulatory Commission, "Disposal of High-Level RadioactiveWastes in Geologic Repositories; Conforming Amendments," 51 FR 22288(June 19, 1986).


26


UNCERTAINTY TITLE: Substantially Complete Containment

CITATION: 10 CFR 60.113(a)(1)(i)(A)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term 'substantially completecontainment" needs interpretation and clarification that is sufficientlyspecific to permit Engineered Barrier System designers to respond with anacceptable design and to provide NRC technical reviewers with a clear-cutbasis for the development of EBS evaluation criteria.


The Nuclear Regulatory Commission (NRC) staff is investigating the needfor further regulatory guidance related to "substantially completecontainment."

RECOMMENDATION RATIONALE: The staff agrees that the term "substantiallycomplete containment" needs further clarification and interpretation toensure that there is no misunderstanding regarding the meaning of thisterm, and a Joint Center for Nuclear Waste Regulatory Analyses(CNWRA)/staff effort is currently underway to assess various alternativesfor reducing the regulatory uncertainty associated with the "containment"requirement. Various alternatives for uncertainty reduction have beenidentified, including alternatives that would provide numerical meaning tothe term "substantially complete containment." The alternativesconsidered range from providing clarification in a technical position orregulatory guide, to modifying the existing language in the rule, toquantify the "containment" requirement. A structured approach is beingemployed for assessing the merits of each of the various alternatives foruncertainty reduction, and a determination will be made regarding the bestchoice for reducing the regulatory uncertainty. After a recommendationfor the uncertainty reduction alternative (i.e., regulatory guide,technical position, rule change) is made, further analysis will be neededto develop the specifics of the alternative selected.

R. Weller, NRC/NMSS, 12/06/90


1. Nuclear Regulatory Commission, memorandum dated March 29, 1989, J. Buntingto R. Browning, "Scoping Paper for Proposed Rulemaking to Minimize theRegulatory Uncertainty regarding Substantially Complete ContaInment."

2. Nuclear Regulatory Commission, memorandum dated October 18, 1989, J.Bunting to R. Browning, "Scoping Paper on Technical Feasibility Assessmentof an Approach to Provide Quantitative Criteria in Lieu of SubstantiallyComplete Containment."

3. Nuclear Regulatory Commission, 'Uncertainty Evaluation Methods for Waste


I

27

Package Performance Assessment," NUREG/CR-5639, January 1991.

4. Center for Nuclear Waste Regulatory Analyses, "Technical Considerationsfor Evaluating Substantially Complete Containment of High-Level Wastewithin the Waste Package," NUREG/CR-5638, December 1990.

5. Center for Nuclear Waste Regulatory Analyses, "'Substantially CompleteContainment' Feasibility Assessment and Alternatives Report," CNWRA90-007, September 1990.


28

UNCERTAINTY NUMBER: 20 (Page E-57, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Solid Waste Form

CITATION: 10 CFR 60.135(c)(1)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: It is uncertain if the statement inthe above regulation, "...all such radioactive wastes shall be in solidform," applies to spent fuel rods, where fission product Vases arecontained and generated. Clarification of the Commission s intentregarding permanent disposal of the radioactive gases contained in spentfuel rods is needed to achieve consistent interpretation and compliance.

RECOMMENDED RESOLUTION APPROACH: Guidance.

Spent fuel rods should be considered to be in solid form notwithstandingthe presence of fission product gases.

RECOMMENDATION RATIONALE: The requirement for such waste to be in a solidform applies to the macroscopic properties of the waste form (e.g., spentfuel rods, vitrified high level waste). Spent fuel contains gaseousfission products (e.g., Kr-85) both within the matrix of the fuel and inthe fuel/cladding gap. Notwithstanding this fact, it has always beenclear that spent fuel was an expected waste form at a geologic repository.The Commission has never suggested that spent fuel would have to betreated to isolate or remove gaseous fission products, to comply with therequirement that emplaced high-level wastes be in a solid form. In fact,"spent nuclear fuel" -- a waste that is intended to be disposed of in ageologic repository -- is defined by the Nuclear Waste Policy Act as fuelwithdrawn from a nuclear reactor, "...the constituent elements of whichhave not been separated by reprocessing." The intent of the rule was torecognize the role that the waste form provides as a key component of theengineered barrier system. Waste In solid form (as opposed to liquid orgaseous waste forms) can contribute significantly to meeting the wastepackage and engineered barrier system performance objectives.



1. 46 FR 130 (July 7, 1981).

2. Nuclear Regulatory Commission, Staff Analysis of Public Comments onProposed Rule 10 CFR Part 60, "Disposal of High-Level Radioactive Wastes inGeologic Repositories, NUREG-0804, December 1983.

3. 42 USC 10101, "The Nuclear Waste Policy Act of 1982.


* N

29

UNCERTAINTY NUMBER:

UNCERTAINTY TITLE:

CITATION:

21 (Page B-63, Appendix B. CNWRA 90-003)

Anticipated Processes and Events

10 CFR 60.113(a), 10 CFR 60.2, and 10 CFR 60.112

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY:events" requires further definitionthe regulatory requirement.

The term "anticipated processes andto permit uniform interpretation of


This uncertainty is scheduled to be resolved in the rulemaking conforming10 CFR Part 60 to the final Environmental Protection Agency (EPA)Standard.

RECOMMENDATION RATIONALE: See Uncertainty No. 17.






30


UNCERTAINTY TITLE: Unanticipated Processes and Events

CITATION: 10 CFR 60.113(c)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "unanticipated processes andevents" requires further definition to permit uniform interpretation ofthe regulatory requirement.


This uncertainty is scheduled to be resolved in the rulemaking conforming10 CFR Part 60 to the final EPA Standard.

RECOMMENDATION RATIONALE: See Uncertainty No. 17.


REFERENCES FOR RATIONALE: -


2. Center for Nuclear Waste Regulatory Analyses, "Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60," CNWRA, February 28, 1990.


31


UNCERTAINTY TITLE: Milestone for Land Ownership and Control


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The implied interpretation that landuse and control need not be established until construction authorizationhas been granted needs clarification. The NRC review and approval of theconstruction authorization (license) application will provide the onlyopportunity to evaluate a demonstration of adequate land ownership andcontrol.


The Department of Energy (DOE) must exercise land ownership and control ina timely manner, as set out in 10 CFR 60.31 and 60.41, but is not requiredto document, in the license application, its having actually acquired thenecessary land interests.

RECOMMENDATION RATIONALE: The regulatory policy is clear--namely, that DOEmust exercise control in a manner that Is sufficiently timely for theCommission to make the licensing determinations set out in 10 CFR 60.31and 10 CFR 60.41. With reference to 10 CFR 60.31, this calls for theCommission to consider whether the site complies with the land ownershipand control requirements of 10 CFR 60.121, and, based on the considerationof this and other factors, to determine whether there is reasonableassurance of safety.

DOE is required to describe the controls it "t...will apply to restrictaccess and to regulate land use" (10 CFR 60.21(c)(8)); it is not, however,required to document its having actually acquired the necessary landinterests. The license application shall be "...as complete as possiblein the light of information that is reasonably available at the time ofdocketing," but other information not available at the constructionauthorization stage may be submitted before issuance of a license (10 CFR60.24). Thus, if DOE has described the needed controls, but has not asyet acquired them, the circumstances must be such that the Commission hasreasonable assurance of safety. This will involve a review of both thecontrols deemed to be necessary and DOE plans for exercising thosecontrols (including, as appropriate, acquisition or withdrawal of landsfor DOE use). To the extent that the Commission finds conditions relatingto such controls to be necessary to protect health and safety, these willbe included in the construction authorization (10 CFR 60.32).


0

32

As a practical matter, it should be borne in mind that Congress might bereluctant to authorize a permanent withdrawal of public lands for DOE'suse until the Nuclear Regulatory Commission (NRC) has issued aconstruction authorization (or license). The regulation recognizes andaccommodates this consideration.

J. Wolf, tNRC/OGC, 11/27/90




REGULATORY AND INSTITUTIONAL UNCERTAINTIES APPENDIX I

a - -- _ . . -_

33

UNCERTAINTY NUMBER:

UNCERTAINTY TITLE:

CITATION:

24 (Page B-74, Appendix B, CNWRA 90-003)

Geologic Setting

10 CFR 60.122(b)(1)

CNWVRA TEXT OF THEsetting," asambiguous. ADeterminationProcesses antclarification

POTENTIAL UNCERTAINTY: The definition ofused throughout 10 CFR 60.122 and defined6 rulemaking ("Generic Technical Position,i of Anticipated Processes and Events and II Events") is currently underway and will 1i of the definition of the term.

the term "geologicIn 10 CFR 60.2, isGuidance forInanticipatedInclude


Further analysis is needed to determine If present 10multiple geologic settings and if the term is for usepost-closure or both pre- and post-closure analysis.

CFR Part 60 allowsin pre-closure,

RECOMMENDATION RATIONALE: Within the definition .of "geologic setting" in10 CFR Part 60, there is an uncertainty as to whether there is a singular"geologic setting" that is applicable to all natural systems, or If thereare multiple "geologic settings," each applicable to Its own system (e.g.,a "geologic setting" for the hydrologic system). There has beendisagreement as to which usage 10 CFR Part 60 allows. In addition, it isuncertain if the term is only applicable for the period after permanentclosure, or if the term is applicable for both pre- and post-closureconcerns. The Nuclear Regulatory Commission (NRC) staff agrees, therefore,that the term "geologic setting" is an uncertainty within the rule. Thiswas originally addressed in the draft "Generic Technical Position onGuidance for Determination of Anticipated Processes and Events andUnanticipated Processes and Events" (see 53 FR 6040). It had been plannedthat final clarification of this term would be included in the rulemakingon "Anticipated Processes and Events and Unanticipated Processes andEvents"; however, with the planned inclusion of the "Anticipated Processesand Events and Unanticipated Processes and Events" rulemaking, in therulemaking conforming 10 CFR Part 60 to the final Environmental ProtectionAgency (EPA) Standard rulemaking (see SECY-90-207), the staff isconsidering the use of a staff technical position to resolve theuncertainty.



1. U.S. Nuclear Regulatory Commission, "First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program,"SECY-90-207, June 1990.

2. U. S. Nuclear Regulatory Commission, "Notice of Availability: Availabilityof Draft Generic Technical Position on 'Guidance for Determination ofAnticipated Processes and Events and Unanticipated Processes and Events,"'53 FR 39, February 29, 1988.


- 34


UNCERTAINTY TITLE: Taking into Account the Degree of Resolution

CITATION: 10 CFR 60.122(a)(2)(i)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The intended meaning of the phrase"taking into account the degree of resolution of the investigations"should be clarified so that DOE has clear guidance on the NRCrequirement to adequately investigate aspects of the given adversecondition necessary to support the license application.


The phrase "taking into account the degree of resolution achieved by theinvestigation" is intended to convey a requirement that the Department ofEnergy (DOE) must factor into both the design and analysis of a geologicrepository the technical limitations of the investigative methodsemployed.


The full text of the regulation containing this potential uncertainty isas follows:

"The potentially adverse human activity or natural condition has beenadequately investigated, including the extent to which the conditionmay be present and still be undetected taking into account the degreeof resolution achieved by the investigations." (10 CFR60.122(a)(2)(i))

Consideration of the sufficiency of both the program on investigations andthe program of analysis must be predicated on an understanding of thetechnical limitations of the program of investigations that was used toobtain the data for design and analysis. In any Nuclear RegulatoryCommission (NRC) licensing action, during the review of the program ofinvestigations, it is expected that the applicant will present his programof investigations and describe the degree of resolution achieved. Forexample, if there is a question, concerning faulting, that could affectthe groundwater flow system at the site (see 10 CFR 60.122(c)(4)), and ageophysical program Is used to investigate potential faulting, NRC wouldexpect the Department of Energy (DOE) to describe the geophysical methodsused, along with the resolution of the method. If the method, forexample, could not detect faults with less than 10 feet of offset, NRCwould expect DOE to clearly state this fact, along with a clearrecognition that faults of lesser offset may be present and undetected.

This uncertainty is the subject of continuing discussion between NRC andthe Center.



35


1. 10 CFR Part 60, "Disposal of High-Level Radioactive Wastes In GeologicalRepositories."



36


UNCERTAINTY TITLE: Not to Affect Significantly

CITATION: 10 CFR 60.122(a)(2)(11i)(A)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The meaning of the phrase "not toaffect significantly" in 60.122(a)(2)(iii)(A) should be clarified in orderfor DOE to demonstrate that the activity or condition in question doesor does not exceed the level of effect considered important in the abilityof a geologic repository to meet the performance objective.


The phrase "not to affect significantly" is intended to convey, In aqualitative sense, the relationship between the effects of the adverseconditions and the ability to achieve a finding of reasonable assurancethat the performance objectives relating to waste isolation have been met.



"The potential adverse human activity or natural condition is shownby analysis pursuant to paragraph (a)(2)(ii) of this section not toaffect significantly the ability of the geologic repository to meetthe performance objectives relating to isolation of the waste....(10 CFR 60.122(a)(2)(iii)(A))

Upon completion of the analysis, it will be necessary to determine if theperformance objectives have been met. The staff considers that an adversecondition that prevents a finding that the performance objectives havebeen met would be a significant effect, whereas an adverse condition thatdoes not prevent such a finding would be one that would be Judged "not toaffect significantly." This reasoning Is supported in the rulemakingrecord in such places as NUREG-0804, where in response to Comment 542, thestaff stated:

"The presence of only one significant condition not adequatelycompensated for by favorable conditions or capable of remedy bydesign would render the site unsuitable, since the performanceobjectives would not be met."

The licensing board will evaluate the evidence presented to it and make adetermination if the performance objectives have been met. It is thestaff opinion that this phrase "not to affect significantly" is anintended uncertainty in the rule, as, until such time as the actuallicensing hearing, it will be impossible to determine if the Department ofEnergy (DOE) will be able to present a case that the performanceobjectives have been met.

This uncertainty is the subject of continuing discussions between theNuclear Regulatory Commission (NRC) and the Center.



37


1. U.S. Nuclear Regulatory Commission, "Staff Analysis of Public Comments onProposed Rule 10 CFR 60, Disposal of High-Level Radioactive Wastes inGeologic Repositories," NUREG-0804, December 1983.




38

UNCERTAINTY NUMBER: 27 (Page 8-86, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Adequately Evaluated

CITATION: 10 CFR 60.122(a)(2)(ii)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The high-order criteria for adequacyof investigations should be defined to guide DOE in determining what typesof evaluations are appropriate and how extensive and intensive they shouldbe. Since technical means of evaluating the 24 potentially adverseconditions will vary considerably, evaluation criteria should be specificto the particular adverse condition. The different evaluation criteriawill be critical to the NRC assessment of the completeness of theindividual technical evaluations that will be presented by DOE in thelicense application.


The criterion to determine adequacy of evaluations (and investigations) isthat the Department of Energy (DOE) evaluation be sufficient to providereasonable assurance that the performance objectives related to wasteIsolation have been met.



"The effect of the potential adverse human activity or naturalcondition on the site has been adequately evaluated using analyseswhich are sensitive to the potential adverse human activity ornatural condition, and assumptions which are not likely to underesti-mate Its effect... ." (10 CFR 60.122(a)(2)(ii))

Once the program of investigations has been completed, the data obtainedmust be analyzed and evaluated against the performance objective. As wasstated in NUREG-0804, in response to Comment 542:

"...it should be understood that the incorporation of the favorableand unfavorable conditions provides an analytical framework forapplying the performance objectives."

The analysis needs to determine which conditions are those most importantin determining compliance with the performance objectives, andaccordingly, should serve as feedback into the investigation program toensure that those conditions that have the largest potential of showingthe site in non-compliance are given the proper priority and attention.This is the underlying assumption behind the various Nuclear RegulatoryCommission (NRC) comments on the performance allocation process presentedby DOE In the site characterization plan. (See, for example, Comment 1,NUREG-1347.) In performing the analysis itself, both sensitivity analysisand uncertainty analysis should be presented so that the true understanding


39

of the effect of the phenomena under consideration on the performanceobjectives can be displayed. The various analyses should demonstrate aconservative approach such that the potential effects from the variousconditions should not be presented in an overly optimistic manner. Thisconcept was presented in the statement of considerations (48 FR 120, p.28201, June 21, 1983) in such places as the discussion of anticipatedprocesses and events and unanticipated processes and events, where theCommission stated:

There are two principal elements that will go into the Commission'sapplication of this "reasonable assurance" concept. First, theperformance assessment which has been performed must indicate thatthe likelihood of exceeding the EPA standard is low. Second, theCommission must be satisfied that the performance assessment issufficiently conservative, and its limitations are sufficiently wellunderstood, that the actual performance of the geologic repositorywill be within the predicted limits.

This uncertainty is the subject of continuing discussions between NRC and-the Center.



1. U.S. Nuclear Regulatory Commission, "Disposal of High-Level RadioactiveWastes in Geologic Repositories, Technical Criteria," 48 FR 28201(June 21, 1983).

2 U.S. Nuclear Regulatory Commission, "Staff Analysis of Public Comments onProposed Rule 10 CFR 60, Disposal of High-Level Radioactive Wastes inGeologic Repositories," NUREG-0804, December 1983.

3. U.S. Nuclear Regulatory Commission, "NRC Staff Site CharacterizationAnalysis of the Department of Energy's Site Characterization Plan, YuccaMountain Site, Nevada," NUREG -1347, August 1989.



I 40


UNCERTAINTY TITLE: Not Likely to Underestimate Its Effect

CITATION: 10 CFR 60.122(a)(2)(1)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The meaning of the term "not likelyto underestimate its effect" Is unclear. The criteria for acceptabilityof a given estimated value, In order for the value to be Judged acceptablewithin the definition "not likely to underestimate Its effects," should beprovided to DOE to allow an appropriate DOE assessment.


The criterion to determine acceptability of any part of the evaluationprocedures is that the Department of Energy (DOE) be able to providereasonable assurance that the performance objectives related to wasteisolation have been met.



* ... the effect of the potential adverse human activity or naturalcondition on the site has been adequately evaluated using analyseswhich are sensitive to the potential adverse human activity ornatural condition and assumptions which are not likely to under-estimate its effect."

Once the program of investigations has- been completed, the data obtainedmust be analyzed and evaluated against the performance objective. As wasstated in NUREG-0804, in response to Comment 542:

i...t should be understood that the incorporation of the favorableand unfavorable conditions provides an analytical framework forapplying the performance objectives."

To the extent that assumptions are required, they must be documented, andthe effect that they have on performance assessment must be evaluated. Inperforming the analysis, DOE should present both sensitivity analysis anduncertainty analysis, so that the true understanding of the effect of thephenomena under consideration, on the performance objectives, can bedisplayed. The various analyses should demonstrate a conservativeapproach such that the potential effects from the various conditionsshould not be presented In an overly optimistic manner. This concept waspresented in the statement of consideration (48 FR 28201, June 21, 1983) insuch places as the discussion of anticipated processes and events andunanticipated processes and events, where the Commission stated:


41

'There are two principal elements that will go Into the Commission'sapplication of this reasonable assurance concept. First, theperformance assessment which has been performed must Indicate thatthe likelihood of exceeding the EPA standard is low. Second, theCommission must be satisfied that the performance assessment issufficiently conservative, and its limitations are sufficientlywell-understood, that the actual performance of the geologicrepository will be within the predicted limits."

In performing the various analyses, it may or may not be necessary to use"worst-case" scenarios, depending on 0...the extent to which they may beencompassed by the definition of unanticipated processes and events" ;however, if compliance can be demonstrated under "worst case conditions,"it is obvious that this would lend confidence that under the expected ornominal case, the performance objectives could be met.




1. 48 FR 28201 (June 21, 1983).

2. The Nuclear Regulatory Commission, "Staff Analysis of Public Comments onProposed Rule 10 CFR 60, Disposal of High-Level Radioactive Wastes inGeologic Repositories," NUREG-0804, December 1983.


42


UNCERTAINTY TITLE: Adequately Investigated

CITATION: 10 CFR 60.122(a)(2)(i)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The criteria for "adequatelyinvestigated" should be defined sufficiently to guide DOE in determiningwhat types and scopes of investigations are appropriate.


The adequacy of the program of investigations is judged in the context ofits ability to provide the necessary information to demonstrate compliancewith the performance objectives.



"The potential adverse human activity or natural condition has beenadequately investigated, Including the extent to which the conditionmay be present and still be undetected taking into account the degreeof resolution achieved by the investigation."

The evaluation of the adequacy of a program of investigations must bebased on consideration of the type, quality, and adequacy of the dataobtained, to resolve the question of repository performance in compliancewith Nuclear Regulatory Commission (NRC) regulations. For example, if, todemonstrate compliance with the performance objectives, it is necessary toshow that there were no faults present, in the area of investigations,that had offset of greater than 5 feet, an assumed 10-foot detection limitwould be a clear example of an inadequate investigation. On the otherhand, if it could be demonstrated that faults of 20 feet or less offsetcould be present and not prevent the performance objectives from being theprogram of Investigations would be Judged adequate for its purpose. Theadequacy of the program of Investigations can only be Judged in thecontext of Its ability to provide the necessary information to demonstratecompliance with the performance objectives.





2. Center for Nuclear Waste Regulatory Analyses, "Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFRPart 60," CNWRA 90-003, February 28, 1990.


43


UNCERTAINTY TITLE: Geologic Setting


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The definition of the term 'geologicsetting," as used throughout 10 CFR 60.122 and defined in 10 CFR 60.2, isambiguous. A rulemaking ("Generic Technical Position, Guidance forDetermination of Anticipated Processes and Events and UnanticipatedProcesses and Events") is currently underway and will includeclarification of the definition of the term.


RECOMMENDATION RATIONALE: See Uncertainty Number 24.






a : I - - - 4 -

41 44


UNCERTAINTY TITLE: Treatment of Combinations of Potentially AdverseConditions

CITATION: 10 CFR 60.21(c)(1)(ii)(C) and 10 CFR 60.122

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: There is an inconsistency in thetreatment of combinations of potentially adverse conditions between 10 CFR60.21(c)(1)(i1)(C) and 10 CFR 60.122. The former allows combinations ofadverse conditions to be used in scenario development, whereas the latterallows only one adverse condition to be compared to a combination offavorable conditions. Thus, synergistic effects of adverse conditionswould not be considered when evaluating the site during site selection andvalidation process.


The synergistic effects of the adverse (and favorable) conditions are tobe considered in the site evaluation and will be discussed extensively inthe License Application Review Plan (LARP).

RECOMMENDATION RATIONALE: The rulemaking record is clear that the synergisticeffects of the favorable and adverse conditions should be considered anddocumented in the license application. For example, in NUREG-0804, inresponse to Comment 542, the Nuclear Regulatory Commission (NRC) staffstated:

"The presence of only one significant condition not adequatelycompensated for by favorable conditions or capable of remedy bydesign would render the site unsuitable since the performanceobjectives would not be met. It should be understood that theincorporation of favorable and unfavorable conditions provides ananalytical framework for applying the performance objectives. It isnot the intention that the conditions be regarded as independentrequirements...."

And, in response to Comment 541, the staff stated:

"The requirement for a combination recognizes the Interactivenature of geologic systems."

Although 10 CFR 60.122(a)(2) does require that each potentially adversecondition must be considered individually, the analysis must be performedin a reasonable way, that is, in a manner that recognizes the interactivenature of the geologic systems. The applicant must not ignore relevantcharacteristics of the geologic setting when carrying out the analysis


-45-

called for by 10 CFR 60.122(a)(2)(ii). Rather, the impact of thepotentially adverse condition must be evaluated in the context of thoseother characteristics so as to form the basis for a Judgement of whetherIts presence significantly affects the ability of the geologic repositoryto meet the performance objectives relating to isolation of the waste. Itis indeed difficult to conceive how one might perform useful analysesunless synergistic effects are taken into account. What 10 CFR 60.122(a)is designed to do is to ensure that useful analyses are performed on thebasis of the identification and detailed considerations of the listedpotentially adverse conditions. Treating those conditions in completeisolation -- given their interactive nature -- would be artificial.Since the rule should be Interpreted, if possible, to support reasoneddecision-making, 10 CFR 60.122 must be construed to allow (and evenrequire) synergistic considerations to be reflected in the analysis ofthe potentially adverse conditions.



1. U.S. Nuclear Regulatory Commission, "Regulatory Strategy and Schedulesfor the High-Level Waste Repository Program," SECY-88-285, October 1988.

2. U.S. Nuclear Regulatory Commission, "First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program,"SECY-90-207, June 1990.



-46-


UNCERTAINTY TITLE: Regional Groundwater Flow System

CITATIONS: 10 CFR 60.122(c)(3)10 CFR 60.122(c)(4)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "regional groundwater flowsystem" can refer to differing geographical regions depending on thegeologic process of interest and the intended breadth of the investiga-tion. A clarification of the intended breadth of the investigations meantto consider "regional groundwater flow system" will allow DOE to respondappropriately to the regulation in the License Application.


Although "regional groundwater flow system" is sufficiently clear,further analysis is required because of the relationship to the "geologicsetting."

RECOMMENDATION RATIONALE: The Center for Nuclear Waste Regulatory Analyses(CNWRA) report (CNWRA 90-003) suggests that use of the term "regional"should be clarified. Most scientific studies at Yucca Mountain arereferred to as either "regional" or "site" studies. These terms generallyrefer to the spatial scale of the studies. In 10 CFR 60.2, the definitionof "site" is "...the location of the controlled area." The NuclearRegulatory Commission (NRC) staff refers to studies on the scale of thecontrolled area or smaller as site studies. Studies on a larger scale,which include the controlled area and areas beyond, are referred to asregional studies. The investigations must be thorough enoughthat detailed analysis will be performed on future changes In the flowsystem that may affect isolation. Such analysis is necessary to determinewhether the performance objectives have been met. Information needs forthe varying scales of regional and site hydrology are identified in NRC'sDraft Regulatory Guide DG 3003, "Format and Content for the LicenseApplication for the High-Level Waste Repository." However, the "regionalgroundwater flow system" is a component of the "geologic setting." Seerationales for uncertainties 24 and 30. For this reason, this uncertaintyhas been placed in the further analysis catagory.

Neil Coleman, NRC/NMSS, 01/23/91



2. Center for Nuclear Waste Regulatory Analyses, "Identification andEvaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60,"1 CNWRA 90-003, February 28, 1990.


-47-

3. The Nuclear Regulatory Commission, "Format and Content for the LicenseApplication for the High-Level Waste Repository," DG-3003, November 1990.

-I


-48-

UNCERTAINTY NUMBER:

UNCERTAINTY TITLE:

CITATIONS:

33 (Page B-108, Appendix B. CNWRA 90-003)

Regional Groundwater Flow System

10 CFR 60.122(c)(3)10 CFR 60.122(c)(4)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "regional groundwater flowsystem" can refer to differing geographical regions depending on thegeologic process of interest and the intended breadth of the investiga-tion. A clarification of the intended breadth of the investigations meantto consider "regional groundwater flow system" will allow DOE to respondappropriately to the regulation in the License Application.


Although "regional groundwater flow system" is sufficiently clear,further analysis is required because of the relationship to the "geologicsetting."

RECOMMENDATION RATIONALE: Refer to Uncertainty Number 32.

Neil Coleman, NRC/NMSS, 01/23/91




Nuclear Waste Regulatory Analyses, "Identification andof Regulatory and Institutional Uncertainties In 10 CFR Part90-003, February 28, 1990.


-49-UNCERTAINTY NUMBER: 34 (Page B-11O, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Sorption of Radionuclides


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The term "sorption of radionuclides"refers to only one of several possible geochemical processes. Theregulatory intent needs to be clarified to ensure a complete and accurateassessment of all the geochemical conditions affecting radionuclidemigration.


The list of geochemical retardation processes that could be adversly reduced,may need to be expanded.

RECOMMENDATION RATIONALE: A reduction in the radionuclide sorption capability of thesite is only one of several retardation processes that could be reduced bygeochemical processes. A reduction in other processes such as matrix diffusionand filtration of radiocolloids may also be of concern. If the Commissionintended for this section of the rule to identify all geochemical conditionsthat could affect radionuclide mobility, then consideration of these otherretardation processes and conditions affecting them would be required.

Further analysis is needed to determine whether and how the rule should bechanged and to determine what form any such change might take.

J. W. Bradbury, NRC/NMSS, 12/06/90


1. The Nuclear Regulatory Commission, Staff Analysis of Public Comments onProposed Rule 10-CFR Part 60, "Disposal of High-Level Radioactive Wastesin Geologic Repositories," NUREG 0804, 1983.


3. Center for Nuclear Regulatory Analyses, "Identification and Evaluation ofRegulatory and Institutional Uncertainties in 10 CFR Part 60," CNWRA90-003, February 28, 1990.


a. -50-


UNCERTAINTY TITLE: Extreme Erosion


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The meaning of "extreme erosion" inthis regulatory context needs to be clarified as to whether it means(1) the highest rate of erosion of a potential site area that might beanticipated based on the rates of erosion experienced during theQuaternary Period, or (2) the rate, which if it were to occur in theforeseeable future, would cause the performance objectives of thegeologic repository to be breached and against which the projectederosion rates based on Quaternary data are to be evaluated.


The term "extreme erosion" is interpreted to mean evidence of substantialchanges in land forms (as a result of erosion) over relatively shortperiods of time, during the Quaternary period.

RECOMMENDATION RATIONALE: The full text of the regulation containing thispotential uncertainty is as follows: "Evidence of extreme erosion duringthe Quaternary Period."

Within NUREG-0804, in response to Question 543, the staff stated thefollowing:

"The staff has used the term "extreme erosion" to refer to theoccurrence of substantial changes in land forms (as a result oferosion) over relatively short periods of time."

The staff considers that this adverse condition implies a straightforwardconcept that has been adequately explained in the context of the abovereference. If the controlled area or areas sufficiently close to thecontrolled area display evidence that there were relatively short periodsof time during the Quaternary in which substantial changes in land formsoccurred, the recurrence of which could affect the ability of the site tomeet the performance objectives, the staff would consider this as evidenceof extreme erosion. The concern is that if extreme erosion would occurduring the period of performance, it could affect the ability of the siteto meet the performance objectives.






p. -51-

3. Center for Nuclear Waste Regulatory Analyses, "Identification andEvaluation of Regulatory and Institutional Uncertainties In 10 CFR Part60," CNWRA 90-003, February 28, 1990.


-52-


UNCERTAINTY TITLE: Air-Filled Pore Spaces


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: Clarification needs to be providedas to whether "air-filled pore spaces" is meant to be interpretedliterally as (1) those spaces filled with a mixture of nitrogen, oxygen,and other constituents, or (2) 'gas-phase filled pore spaces." The latterinterpretation would require pores filled with methane, carbon dioxide,and various mixtures of earth-derived and barrier system-derived gases tobe considered in potential transport mechanisms involving radionuclides.


"Air-filled" pore spaces should be interpreted as gas-phase filled porespaces in the context of the three primary states of matter - gas, liquid,and solid.

RECOMMENDATION RATIONALE: This specific adverse condition was added to 10 CFRPart 60 in the amendment to Part 60 to contain specific criteria fordisposal in the unsaturated zone. In the supplementary information (50 FR29641) and supporting technical information (NUREG-1046), it wasrecognized that "...surface air can be connected with water and air at thehorizon of the underground facility through open pores and fracturechannels within the host rock" (see NUREG-1046, p. 15), and "...theunsaturated geologic media surrounding the underground facility will bepartially drained and will possess connected air-filled pores that can formpotential pathways for gaseous movement" (see NUREG-1046, p. 20), and... vapor transport might only be expected to occur in the portion of the

host rock where voids are not completely filled or refilled withgroundwater" (see50 FR 29046). It is obvious from these and otherstatements contained within these documents that the Commission wasconsidering the "air-filled pore spaces" in the context of the primarystates of matter -- gas, liquid, and solid -- that is, pore spaces not filledwith solid or liquid matter. Furthermore, these references recognizetransport of radionuclides in the gaseous state as encompassing allpotential conditions, as there are specific references to carbon dioxide,methane, hydrogen, krypton, iodine, and aerosol-size particles ofgroundwater -- among others -- as possible means of radionuclidetransport In the unsaturated zone. (See, for example, NUREG-1046, p. 21.)In the "Statement of Considerations' for the amendment to 10 CFR Part 60,the Commission stated: 'The term 'vapor transport' as used In the proposedamendments, referred to both water vapor and the gaseous state of someconstituents' contaminants.... The Commission believes the revised wordingwill more accurately convey its original intent."

J. W. Bradbury, NRC/NMSS, 12/06/90


-53-




3. U.S. Nuclear Regulatory Commission, "Statements of Consideration, Part 60,Disposal of High-Level Radioactive Wastes in Geologic Repositories,Licensing Procedures," 46 FR 13971.

4. U.S. Nuclear Regulatory Commission, "Disposal of High-Level RadioactiveWastes in the Unsaturated Zone: Technical Considerations and Response toComments," NUREG-1046, September 1985.

S. U.S. Nuclear Regulatory Commission, "Disposal of High-Level RadioactiveWastes in Geologic Repositories," Federal Register, Vol. 50, No. 140, pp.29641-29648, 1985.


-54-


UNCERTAINTY TITLE: Design All Utility Testing for Essential Function


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: Additional guidance Is neededregarding on-line operability testing of auxiliary and redundant systems.On-line operability testing should be explicitly required for redundant,auxiliary, and backup elements of the utility systems. This uncertaintyneeds to be addressed to ensure adequacy of design and operation ofsystems important to safety under normal and accident conditions.


On-line operability testing of redundant and reliable and timely emergencysystems important to safety is already encompassed in 10 CFR 60.131(b)(6).

RECOMMENDATION RATIONALE: The question is whether existing regulations provideadequately for on-line operability testing of auxiliary and redundantutility systems. Apparently, the Center for Nuclear Waste RegulatoryAnalyses (CNWRA) recognizes that the primary systems are already subjectto appropriate testing requirements under 60.131(b)(6) -- a view shared bythe staff. This interpretation rests on the view that those primarysystems are "important to safety" and that they must be subject toon-line operability testing, so as to satisfy the requirement in10 CFR 60.131(b)(6) for design as necessary to ensure continuedfunctioning and readiness. The redundant, auxiliary, and backup systems,if important to safety, would be equally subject to the on-lineoperability testing requirement.




2. Center for Nuclear Waste Regulatory Analyses, 'Identification andEvaluation of Regulatory and Institutional Uncertainties in

- 10 CFR Part 60,"t CNWRA 90-003, February 28, 1990.


-55-


UNCERTAINTY TITLE: "Designed to Permit Periodic Inspection"


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: 10 CFR 60.131(b)(6) provides fordesigning to permit periodic inspection, testing and maintenance asnecessary, to ensure their continued functioning and readiness.Regulatory guidance needs to be provided to require designing formaintenance that Is nonperiodic.

Guidance regarding nonperiodic (i.e., corrective) maintenance shouldclarify for DOE the overall maintainability required in the design ofstructures, systems and components important to safety.


Designing for non-periodic maintenance is included In 10 CFR 60.131(b)(6).

RECOMMENDATION RATIONALE: Although the term "periodic" often implies theoccurrence of an event at regular intervals, it can also refer to eventsoccurring infrequently or from time to time. In the-context of 10 CFR60.131, the term "periodic" Is meant to cover inspections that are conductednot only at regularly scheduled intervals but also those that are performedon a nonroutine basis. It would be illogical-to design for inspection,testing, and maintenance only at fixed intervals, if testing or otheroccasions is also necessary. The design should accommodate the need forspecial maintenance on modifications to the facility. Furthermore, theregulations provide an alternative adequate basis for this design element,in that 10 CFR 60.130 declares that omissions in 10 CFR 60.131 do notrelieve the Department of Energy (DOE) from any obligation to providesafety features needed to achieve its performance objectives.

Naiem Tanious, NRC/NMSS, 01/28/91


1. 10 CFR Part 60, "Disposal of High-Level Radioactive Wastes In GeologicalRepositories."

2. Center for Nuclear Waste Regulatory Analyses, "Identification'andEvaluation of Regulatory and Institutional Uncertainties in 10 CFR Part60," CNWRA 90-003, February 28, 1990.


-56-


UNCERTAINTY TITLE: Secondary Effects/Non-Radiological Accidents


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: It is uncertain how NRC is goingto determine compliance with mining regulations; as they relate tononradiological accidents whose secondary effects are radiologicalaccidents.

The uncertainty needs to be addressed to ensure adequate oversight of allpotential sources of radiological accidents, as well as worker health andsafety in the geologic repository operations area.


The Nuclear Regulatory Commission (NRC) has no responsibility or authorityto determine compliance with mining regulations. However, NRC is concernedwith worker protection as necessary to ensure that structures, systems, andcomponents important to safety can perform their intended functions.

RECOMMENDATION RATIONALE: The cited regulation requires that the design ofthe geologic repository operations area is to include provisions forworker protection, so that structures, systems, and components importantto safety can perform their intended functions. That is as far as the NRChas jurisdiction. It is not the Commission's role to provide oversight ofworker safety generally. Thus, while the mining regulations are a guideto the required design, it is not NRC's role to "determine compliance"with those regulations themselves. The staff recognizes thatidentification of the particular design features that must be includedinvolves technical uncertainties that will need to be addressed.



I. 10 CFR Part 60, 'Disposal of High-Level Radioactive Wastes in GeologicalRepositories."



-57-


UNCERTAINTY TITLE: Insufficient Guidance in Design Criteria


CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: Additional or more generic guidanceis needed for the design of waste conveyances, to assure that theperformance objectives will be met if the waste transfer system includestransfer methods other than shafts and hoists (e.g., ramps and vehicles).


Safety of waste transfer methods other than shafts and hoists is coveredadequately by other design criteria.

RECOMMENDATION RATIONALE: This uncertainty calls for additional or moregeneric guidance for waste-transfer methods other than shafts and hoists(which are often bottlenecks and safety concerns), for example, ramps andvehicles. The staff agrees that the latter transfer methods are notaddressed by the paragraph in question. The Issue, thus, is not what theregulation means, but rather, whether there is a need for analogousprovisions for waste-transfer methods other than shafts and hoists. Thestaff believes there is no such need, as the regulations already contain anumber of relevant design features (e.g., protection against dynamiceffects of equipment failure (10 CFR 60.131(b)(2)), instrumentation andcontrol systems (10 CFR 60.131(b)(8)), etc.), as well as the overallrequirement (10 CFR 60.130) for design to achieve the performanceobjectives.






I - --

* ~~~~~~~~~-58-


UNCERTAINTY TITLE: Will NRC Regulate Non-Radiological Safety?

CITATION: 10 CFR 60.133(e)

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: The NRC intent needs to be clarifiedas to whether, and to what extent, the term usafely," as used in thisparagraph, applies to:

1) radiological safety,2) nonradiological "mining" safety (i.e., primarily

personnel safety in overall construction andnonradiological operations),

3) nonradiological incidents that have thepotential to cause radiological accidents, or

4) a combination of the above.

NRC needs to address the application of the term "safely" as applied tounderground openings, deleterious rock movement, and worker safety in theunderground facility, In order to provide guidance to the Department ofEnergy (DOE) that will help ensure adequacy of design and operation in theunderground facility at the geologic repository operations area.


'Safely" means that there should be protection against any injuriesthat would give rise to significant radiological consequences.

RECOMMENDATION RATIONALE: As stated in 10 CFR 60.130, the specific designcriteria are "...minimum criteria for the design of the geologicrepository operations area." Further, "These design criteria are notintended to be exhaustive, however. Omissions in 10 CFR 60.131 through60.134 do not relieve DOE from any obligations to provide safety featuresin a specific facility needed to achieve the performance objectives."Since the performance objectives are all radiological standards, thedesign criteria must be interpreted with that scope in mind. However,because some traumatic accidents may have radiological implications, eventhough they are not radiological per se, they are of concern.Accordingly, when the regulations call for the design to ensure thatoperations can be carried out "safely," it means that there should beprotection against any injuries that would give rise to significantradiological consequences.





EsL. e& - - - Av

-59-


Nuclear Waste Regulatory Analyses, "Identification andof Regulatory and Institutional Uncertainties In 10 CFR Part90-003, February 28, 1990.

.4


A . !- i_ - . A .

,. S

-60-

UNCERTAINTY NUMBER: 42 (page B-160, Appendix B, CNWRA 90-003)

UNCERTAINTY TITLE: Unpublished Subpart I in 10 CFR 60

CITATION: Subpart I

CNWRA TEXT OF THE POTENTIAL UNCERTAINTY: 10 CFR 60.31(a)(5) requires the NRCto ensure compliance of the DOE emergency plan with Subpart I of 10 CFRPart 60. 10 CFR 60.21(c)(9) requires DOE to include plans for coping withradiological emergencies in the Safety Analysis Report. However, it isuncertain that this is possible, since Subpart I has not been published.


The Commission plans to Initiate rulemaking to establish emergencyplanning criteria under Subpart I in 10 CFR Part 60.

RECOMMENDATION RATIONALE: The reserved Subpart I, "Emergency PlanningCriteria," is intended to resolve this uncertainty when completed.

Because 10 CFR 60.31(a)(5) requires the Department of Energy's (DOE's)emergency plan to be in compliance with 10 CFR Part 60, Subpart I, at thetime a Construction Authorization is issued, DOE must know the NuclearRegulatory Commission's (NRC's) "Emergency Planning Criteria," to preparethe License Application. A policy and technical basis for the intendedrulemaking will be developed and rulemaking undertaken as set forth inSECY 90-207.



1. 10 CFR Part 60, "Disposal of High-Level Radioactive Waste in GeologicalRepositories."



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UNCERTAINTY NUMBER: 43 (Enclosure 5, SECY 90-207)

UNCERTAINTY TITLE: Applicability of Siting Criteria to PerformanceObjectives '

NRC TEXT OF THE POTENTIAL UNCERTAINTY: The phrase in 10 CFR 60.122, "...tomeet the performance objectives relating to isolation of the waste,u couldbe interpreted to mean that the siting criteria in 10 CFR 60.122 applyonly to the overall system performance objective in 10 CFR 60.112 or tothe subsystem performance objectives in 10 CFR 60.113, as well.


Staff Position SP 60-002, published August 8, 1990.

STAFF POSITION: In 10 CFR 60.122(a), the phrase "performance objectivesrelating to isolation of the waste" refers to the performance objectives setout in 10 CFR 60.112, "Overall System Performance Objective for the GeologicRepository After Permanent Closure," and 10 CFR 60.113, "Performance ofParticular Barriers After Permanent Closure," but does not refer to theperformance objectives set out in 10 CFR 60.111.

RECOMMENDATION RATIONALE: Section 10 CFR 60.122(a) contains the phrase"performance objectives relating to isolation of the waste" in severalplaces. The question is: What are the "performance objectives relatingto isolation of the waste" that must be considered? The term "isolationof waste" is discussed in 10 CFR 60.102, "Concepts," and is as follows:

"(e) Isolation of waste. (1) During the first several hundred yearsfollowing permanent closure of a geologic repository, when radiation andthermal levels are high and the uncertainties In assessing repositoryperformance are large, special emphasis is placed upon the ability tocontain the wastes by waste packages within an engineered barrier system.This is known as the containment period. The engineered barrier systemincludes the waste packages and the underground facility....

(2) Following the containment period special emphasis is placed upon theability to achieve isolation of the wastes by virtue of thecharacteristics of the geologic repository. The engineered barrier systemworks to control the release of radioactive material to the geologicsetting and the geologic setting works to control the release ofradioactive material to the accessible environment. Isolation meansinhibiting the transport of radioactive material so that amoupts andconcentrations of the materials entering the accessible environment willbe kept within prescribed limits." [emphasis in original]

It is clear that the term "isolation" is used only In reference to theperiod after permanent closure. The performance objectives for theperiod of repository operations contained in 10 CFR 60.11 relate toradiation protection during preclosure repository operations and do notpertain to isolation of the waste after permanent closure. Therefore,the staff has concluded that the preclosure performance objectives of10 CFR 60.111 are unrelated to waste isolation and are not encompassedby the term performance objectives relating to isolation of the waste"in 10 CFR 60.122.


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The performance objectives of 10 CFR 60.112, which implement the overallU.S. Environmental Protection Agency (EPA) Standard in 40 CFR Part 191 byreference, establish limits for amounts and concentrations of materialentering the accessible environment after permanent closure. Thus, itis clear that in using the term "performance objectives relating toisolation of the waste,' the Commission had in mind at least the overallEPA Standard.

The staff considers that the performance objectives set out in 10 CFR60.113 also relate to isolation of the waste and that they should beconsidered when applying 10 CFR 60.122. Justification for this positioncan be found In the "Statement of Considerations" accompanying the proposedtechnical criteria for Subpart E in 10 CFR Part 60, 46 FR 35280, July 8,1981 (at pp. 35283-84). There, the Commission observed that in order tohave confidence in the ability of a geological repository to contain andisolate the wastes for an extended period of time, the repository mustconsist of multiple barriers -- specifically, It concluded, two majorengineered barriers (waste packages and underground facility), in additionto the natural barrier provided by the geological setting. The Commissionemphasized these elements "...to take advantage of the opportunity toattain greater confidence in the isolation of the waste."

It is clear, therefore, that when the Commission referenced "performanceobjectives relating to isolation of the waste," it had in mind themultiple performance objectives set out in 10 CFR 60.113, as well as theoverall EPA Standard that is implemented by 10 CFR 60.112.

This staff position reflects sound policy considerations. It calls forthe applicant to consider the siting criteria, as specified in lD CFR60..22, to demonstrate -- for each of the relevant performance objectivesreferenced previously -- that the favorable conditions, together with theengineering barrier system, are sufficient to provide reasonable assurancethat such objectives will be met, and that any potentially adversecondition will not compromise the ability of the geologic repository tomeet such objectives. If the applicant is unable to make such ademonstration, it seems unlikely that it could otherwise satisfy therequirements of 10 CFR 60.113 that the Commission so emphasized.

Finally, it should be noted that the current position is a clarificationof the applicability of 10 CFR 60.122. It does not modify the performanceobjectives. In fact, the scope of 10 CFR 60.122 is limited by thespecific language of those performance objectives. In particular, theposition does not imply the need for additional analysis of favorable orpotentially adverse conditions, where such conditions have no relevance toa given performance objective.

J.S. Trapp, NMSS, 01/29/91


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1. U.S. Nuclear Regulatory Commission, 'First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program," Secy90-207, June 7, 1990.

2. U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety andSafeguards, SP 60-002, August 8, 1990.


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UNCERTAINTY NUMBER: 44 (Enclosure 5, SECY 90-207)

UNCERTAINTY TITLE: Applicability of Thermal-Load Requirement toPerformance Objectives

NRC TEXT OF THE POTENTIAL UNCERTAINTY: The thermal-load requirement in 10 CFR60.133(1) could be interpreted to apply to only the pre-closureperformance objectives in 10 CFR 60.111, or to the post-closureperformance objectives in 10 CFR 60.112 and 10 CFR 60.113, as well.


Staff Position SP 60-003, published August 8, 1990.

STAFF POSITION: The term "performance objectives,6' as used in Section60.133(i) of 10 CFR Part 60, is considered, by the Nuclear RegulatoryCommission (NRC) staff, to apply to both the preclosure and postclosureperformance objectives identified in 10 CFR 60.112 and 113.

RECOMMENDATION RATIONALE: 10 CFR 60.133(i) falls within a portion of the ruleentitled, "Design Criteria for the Geologic Repository Operations Area."The "Geologic Repository Operations Area" is defined in 10 CFR 60.2 as:"Geologic Repository Operations Area means a high-level radioactive wastefacility that is part of a geologic repository, including both surface andsubsurface areas where waste handling activities are conducted" (emphasisadded). The presence of the word "are" in the last sentence seems tolimit the applicability of the regulations under this heading to thepreclosure period, thus excluding the performance objectives stated in 10CFR 60.112 and 60.113.

On the other hand, 10 CFR 60.112 and 60.113 identify postclosureperformance objectives that must be considered when designing theEngineered Barrier System (EBS). The EBS includes the undergroundfacility. 10 CFR 60.133(i) is a design criterion for the undergroundfacility. Thus, since 60.133(t) is such a criterion, it appears to bea design criterion applicable to achieving the postclosure performanceobjectives of 10 CFR 60.112 and 60.113.

However, both the language and regulatory history of 10 CFR 60.133 affordample support that the design of the underground facility should considershort-term and long-term thermal loads. Thus, in proposing its technicalcriteria (46 FR 35280, July 8, 1981, p. 35285), the Commission explainedthat the technical criteria required the design of the repository toaccommodate potential interaction of the waste, the underground facility,and the site. The rationale for this policy was stated thus: 'TheCommission believes such requirements are necessary to assure that theability of the repository to contain and isolate the wastes will not becompromised by the construction of the repository." The rule as it wasthen being proposed, 10 CFR 60.132(k), called for the underground facilityto be designed so that the predicted thermal and thermomechanical responseof the rock will not degrade significantly the performance of therepository or the ability of the natural or engineered barriers to retardradionuclide migration. This was an unequivocal reference to long-term


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(postclosure) performance. Although the final regulation was modified,there was no change in intent, for the Commission indicated that thespecific reference to retardation of radionuclide migration -- which wasdeleted -- "...Is already covered by requiring that the performanceobjectives be met." (46 FR 28194, June 21, 1983, p. 28215)

Moreover, the regulations reveal that the drafters consciously restrictedthe scope of the performance objectives to preclosure concerns, where thatwas the intent - as in 10 CFR 60.133(g)(1), which requires design of theventilation facility to control certain functions "...in accordance withthe performance objectives of 10 CFR 60.111(a)" -- that is, preclosurecriteria.





3. U.S. Nuclear Regulatory Commission, "First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program," SECY90-207, June 7, 1990.

4. U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety andSafeguards, SP 60-003, August 8, 1990.


I . ,

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UNCERTAINTY TITLE: Waste Package Containment Time Frame

NRC TEXT OF THE POTENTIAL UNCERTAINTY: The phrase "...not less than 300 yearsnor more than 1000 years.. ." from 10 CFR 60.113(a)(1)(ii)(A) can possiblybe taken out of context and interpreted to mean (1) that the waste packagemust be designed to have a lifetime no greater than the stated period or(2) that, in assessing the performance of the waste package and theengineered barrier system, one must assume that the waste package fails atthe end of the stated period.


Staff Position SP 60-001, published July 27, 1990.

STAFF POSITION: The requirement in 10 CFR 60.113(a)(1)(ii)(A) forsubstantially complete containment of high-level wastes within the wastepackages for a period not less than 00 years nor more than 1000 yearsafter repository closure Is a minimum performance requirement that isnot intended, and should not be Interpreted, as a cap on the waste-packagelifetime or a limitation on the credit that can be taken (in engineeredbarrier system and overall repository system performance assessments), ifthe waste package is designed to provide containment in excess of 1000years.

RECOMMENDATION RATIONALE: A complete rationale is set out in Staff Position60-001.

R. Weller, NRC/NMSS, 12/06/90REFERENCES FOR RATIONALE:



3. U.S. Nuclear Regulatory Commission, "First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program," SECY90-207, July 7, 1990.

4. U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety andSafeguards, SP 60-001, July 27, 1990.


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UNCERTAINTY NUMBER: 46 (Enclosure 5, SECY-90-207)

UNCERTAINTY TITLE: Engineered Barrier System Radionuclide Release RateLimit

CITATION: 10 CFR 60.113(a)(1)(il)(B)

NRC TEXT OF THE POTENTIAL UNCERTAINTY: The annualized radionuclide releaserate limits in 10 CFR 60.113(a)(1)(il)(B) are based on the inventory ofradionuclides present at 1000 years following permanent closure of therepository. As such, for some radionuclides (e.g., Am-241 and Pu-240),the allowed releases from the engineered barrier system (EBS) can beseveral orders of magnitude greater than releases to the accessibleenvironment permitted by the overall performance objective (i.e., the U.S.Environmental Protection Agency (EPA) Standard). The underlying purposeof the EBS release rate limit, together with other subsystem performanceobjectives, is to enhance the Commission's confidence that the EPAStandard will be met.


Further analysis is needed to determine whether the EBS release ratelimit does, in fact, enhance confidence that the EPA Standard will be met.

RECOMMENDATION RATIONALE: The staff recognizes that there is a lack of a directtechnical nexus between the EBS release rate limit and the EPA Standard,and that permitted releases are more dependent on radionuclide half-lifeand emplaced inventory than on any linkage with the EPA Standard.Accordingly, there is an open question about whether the subsystemrequirement satisfies its intended purpose of enhancing the Commission'sconfidence that the EPA Standard will be met.





.0 I

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2. U.S. Nuclear Regulatory Commission, "FIrst Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program,"SECY-90-207, June 7, 1990.

3. U.S. Nuclear Regulatory Commission, Staff Analysis of Public Comments onProposed Rule 10 CFR Part 60, 'Disposal of High-Level Radioactive Wastesin Geologic Repositories, NUREG-0804, December 1983.



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UNCERTAINTY NUMBER: 47 (Enclosure 6, Secy 90-207)

UNCERTAINTY TITLE: Reference to Applicable Mine Safety Requirements


NRC TEXT OF THE POTENTIAL UNCERTAINTY: The reference in 10 CFR 60.131(b)(9) tothe applicable mine safety requirements does not reflect the reorganizationand renumbering of mine safety requirements in 30 CFR, Chapter I whichoccurred after 10 CFR Part 60 was issued.

RECOMMENDED RESOLUTION APPROACH: Further Analysis.

Although only minor amendments are needed to address the specificuncertainty, further analysis is needed in order to deal with relatedissues.

RECOMMENDATION RATIONALE: 10 CFR 60.131(b)(9) references mine safetyregulations 30 CFR, Chapter I, Subchapters D, E, and N. The citedregulations have been revised, and the references in the NuclearRegulatory Commission (NRC) regulations are now out of date andincorrect. A straightforward resolution would be a minor rulemakingthat simply updates these references. However, there are certainrelated issues that should be addressed concurrently. The first ofthese involves possible deletion of all references to the cited MineSafety and Health Administration (MSHA) regulations. A second matterconcerns elimination of the reference to MSHA Jurisdiction, since theIssue of MSHA Jurisdiction no longer remains open (since the geologicrepository presently being characterized will not be considered a "mine").Taking these concerns into account, the rule might be revised to readas follows: "The design of the geologic repository operations area shallinclude such provisions for worker protection as may be necessary toprovide reasonable assurance that all structures, systems, andcomponents important to safety can perform their intended functions."





3. Memorandum to R. M. Bernero, U.S. Nuclear Regulatory Commission, from W.C.Parler, U.S. Nuclear Regulatory Commission, on the subject of "10 CFR60.131.(b)(9), Compliance with Mining Regulations," November 16, 1989.


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UNCERTAINTY NUMBER: 48 (Enclosure S. SECY 90-207)

UNCERTAINTY TITLE: Topical Guidelines for Licensing Support System (LSS)

CITATION: 10 CFR Part 2.1003

NRC TEXT OF THE POTENTIAL UNCERTAINTY: Interim topical guidelines, drafted bythe parties to the LSS negotiated rulemaking, were adopted by the U.S.Nuclear Regulatory Commission (NRC) with the statement that the topicalguidelines would be revised later and set forth as a regulatory guide.The interim topical guidelines, partially modeled after the EnvironmentalAssessments prepared in connection with the U.S. Department of Energy's(DOE's) site selection process, need to be revised to describe all theinformation that should be submitted to the LSS to support the high-levelwaste repository licensing process. This revision will clarify the listof topics for which the LSS participants should submit documentarymaterials for entry into the LSS under 10 CFR 2.1003.


The Nuclear Regulatory Commission (NRC) will publish a draft regulatoryguide containing the revised topical guidelines. Availability of thedraft regulatory guide for public comment will be in noticed in theFederal Register.

RECOMMENDATION RATIONALE: NRC has committed to prepare an LSS topicalguidelines regulatory guide, as noted in SECY 90-207, and a draft topicalguideline will be published for public comment in the Federal Register.

P. M. Altomare, NRC/NMSS, 12/06/90




3. U.S. Nuclear Regulatory Commission, "First update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program,' SECY90-207, June 7, 1990. .

4. U.S. Nuclear Regulatory Commission, "Submission and Management of Recordsand Documents Related to the Licensing of a Geologic Repository for theDisposal of High-Level Radioactive Waste," 54 FR 14925 (April 14, 1991).


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UNCERTAINTY NUMBER: 49 (Enclosure 6, SECY-90-207)

UNCERTAINTY TITLE: Criteria for Containment of Greater-Than-Class-C(GTCC) Low-Level Waste (LLW)

CITATION: 10 CFR 60.113(a)(1)(ii)(A)

NRC TEXT OF THE POTENTIAL UNCERTAINTY: Notwithstanding the generalapplicability of 10 CFR Part 60 to waste types other than high-level waste(HLW) that might be emplaced in a repository, some of the specific 10 CFRPart 60 waste package design and performance requirements are applicableonly to HLW and are inapplicable to GTCC LLW. Specifically, the wastepackage containment requirement of 10 CFR 60.113(a)(1)(ii)(A) isapplicable only to HLW, whereas the release rate requirement of 10 CFR60.113(a)(1)(ii)(B) is applicable to both HLW and GTCC LLW. The staff doesnot believe that it was the Commission's intent, in 10 CFR Part 60, tospecify a performance requirement for GTCC LLW, for the post-containmentperiod while specifying none for the containment period. Thus, In itspresent form, 10 CFR Part 60 is incongruous with respect to performancerequirements for waste other than HLW.


Further analysis is needed to determine whether the existing incongruityin 10 CFR Part 60 related to the performance requirements for GTCC LLWshould be resolved.

RECOMMENDATION RATIONALE: The difference between the requirements for HLW andother wastes does not necessarily imply the need for rulemaking. Forinstance, GTCC LLW may never be disposed cf in a repository, since theDepartment of Energy (DOE) has the option of proposing disposal of suchmaterial in an intermediate waste facility that would not be licensedunder 10 CFR Part 60. In this regard, the staff understands that DOE iscurrently assessing a variety of options for the disposal of GTCC LLW,including disposal In a geologic repository. As part of this assessment,DOE is also developing a better understanding of the projected volume andcharacteristics of GTCC LLW, to aid planning for disposal. Until DOEcompletes these assessments and formulates its plans for disposal of GTCCLLW, the staff does.not intend to pursue any further resolution.

This is consistent with the statement of the Commission when it adopted itstechnical criteria:

..

Since the Commission does not know what other radioactive wastes, ifany, will also be emplaced, and what their chemical, radiological,thermal, and other characteristics may be, it has decided to leavepertinent waste package requirements to be determined on a case bycase basis as the need arises. [48FR28201]



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1. 10 CFR Part 60, 'Disposal of High-Level Radioactive Wastes in GeologicalRepositories.'

2. U.S. Nuclear Regulatory Commission, "Regulatory Strategy and Schedules forthe High-Level Waste Repository Program," SECY 88-285, October 1988.

3. U.S. Nuclear Regulatory Commission, 'First Update of the RegulatoryStrategy and Schedules for the High-Level Waste Repository Program," SECY90-207, June 7, 1990.

4. Memorandum to R. E. Browning, U.S. Nuclear Regulatory Commission, fromJ.0. Bunting, U.S. Nuclear Regulatory Commission, forwarding scoping paperfor proposed rulemaking, "Disposal of Greater-than-Class-C Low-LevelRadioactive Waste in a Geologic Repository," July 26, 1990.

5. Letter to J. Linehan, U.S. Nuclear Regulatory Commission, from J. Coleman,U.S. Department of Energy, July 2, 1990.

6. 48 FR 28201 (June 30, 1983).


Documents

NUCLEAR REGULATORY COMMISSION · LSS CENTRAL FILE MFederline, HLHP iOFC ____ LPD | in I N AME AGardi,, / knhAn1f JY 1b od DATE 03/2/93 ' __/_ _93____ ... Regulatory Guide DG-3003,

NUCLEAR REGULATORY COMMISSION · LSS CENTRAL FILE MFederline, HLHP iOFC __ LPD | in I N AME AGardi,, / knhAn1f JY 1b od DATE 03/2/93 ' /_ _93____ ... Regulatory Guide DG-3003,