ML23156A022

PR-060 - 58FR36902 - Disposal of High-Level Radioactive Wastes in Geologic Repositories; Investigation an Devaluation of Potentially Adverse Conditions

ML23156A022
Person / Time
Issue date:	07/09/1993
From:	Chilk S NRC/SECY
To:
References
58FR36902, PR-060
Download: ML23156A022 (1)

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ADAMS Template: SECY-067 DOCUMENT DATE: 07/09/1993 TITLE: PR-060 - 58FR36902 - DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES; INVESTIGATION AN DEVALUATION OF POTENTIALLY ADVERSE CONDITIONS CASE

REFERENCE:

PR-060 58FR36902 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-060 OPEN ITEM (Y/N) N RULE NAME: DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES; INVESTIGATION AND EVALUATION OF POTENTIALLY ADVERSE CONDITIONS PROPOSED RULE FED REG CITE: ~8FR36902 PROPOSED RULE PUBLICATION DATE: 07/09/93 NUMBER OF COMMENTS: 6 ORIGINAL DATE FOR COMMENTS: 10/07/93 EXTENSION DATE: I I FINAL RULE*::jim.* .REG. CITE: FINAL RULE PUBLICATION DATE: I I NOTES ON: PROPOSED RULE WITHDRAWN BECAUSE NRC IS DEVELOPING SITE-SPECIFIC DI STATUS SPOSAL REGULATIONS FOR YUCCA MOUNTAIN, NV CONSISTENT WITH ENERGY P OF RULE: OLICY ACT OF 1992. FILE IN 16-G4.

HISTORY OF THE RULE PART AFFECTED: PR-060 RULE TITLE: DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES; INVESTIGATION AND EVALUATION OF POTENTIALLY ADVERSE CONDITIONS PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 93-144 SRM DATE: 06/17/93 SIGNED BY SECRETARY: 07/02/93 FINAL Rt7J;..B FINAL RULE DATE FINAL RULE SECY PAPER: 95-019 SRM.DATE: I I SIGNED BY SECRETARY: I I STAFF CONTACTS ON THE RULE CONTACT!: MARKS. DELLIGATTI MAIL STOP: 4-H-3 PHONE: 504-2430 CONTACT2: JANET P. KOTRA MAIL STOP: T-7F3 PHONE: 415-6674

DOCKET NO. PR-060 (58FR36902)

In the Matter of DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES; INVESTIGATION AND EVALUATION OF POTENTIALLY ADVERSE CONDITIONS DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 07/02/93 07/02/93 FEDERAL REGISTER NOTICE - PROPOSED RULE 07/29/93 07/26/93 COMMENT OF FRANK CLEMENTS ( 1) 10/07/93 10/04/93 COMMENT OF ENVIRONMENTAL PROTECTION AGENCY (RICHARD E. SANDERSON) ( 2) 10/08/93 10/04/93 COMMENT OF DEPARTMENT OF ENERGY (DWIGHT E. SHELOR) ( 3) 10/08/93 10/07/93 COMMENT OF EDISON ELECTRIC INSTITUTE (DAVID L. SWANSON, SR. V. P.) ( 4) 10/12/93 10/07/93 COMMENT OF NEVADA AGENCY FOR NUCLEAR PROJECTS (ROBERT R. LOUX, DIRECTOR) ( 5)

.11/05/93 10/05/93 COMMENT OF.NYE COUNTY NEVADA NUCLEAR WASTE REPOSITORY (LES W. BRADSHAW) ( 6) 09/02/98 08/31/98 FEDERAL REGISTER NOTICE - PROPOSED RULE:

WITHDRAWAL

R<Po DOCKETED USNRC

[7590-01-P]

Nuclear Regulatory Commission "98 SEP -2 A9 :27 10 CFR Part 60 RIN 3150-AE40 OF:-,1, \ 1 F f R I ~-" ,<

Clarification of the Assessment Requirements for the Siting Crit~~J,,1t,, '

Performance Objectives AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule: Withdrawal.

SUMMARY

The Nuclear Regulatory Commission (NRC) is withdrawing a proposed rule that would clarify uncertainties in regulations that contain generic criteria governing the disposal of high-level radioactive wastes (HLW) in geologic repositories. Because the NRC is developing site-specific disposal regulations for Yucca Mountain, Nevada, consistent with the Energy Policy Act of 1992 (EnPA), the proposed rule is being withdrawn.

FOR FURTHER INFORMATION CONTACT: Janet P. Kotra, Performance Assessment and High-Level Waste Integration Branch, Division of Waste Management, Office of Nuclear Material Safety and Safeguards, Nuclear Regulatory Commission, 11545 Rockville Pike, Rockville, Maryland 20852-2738. Telephone 301/415-6674. E-mail JPK@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Existing NRC regulations at 10 CFR Part 60, initially issued in 1983, contain generic criteria governing the disposal of HLW in a geologic repository. On July 9, 1993 (58 FR 36902), the NRC published, for public comment, proposed amendments intended to clarify certain regulatory uncertainties in those regulations related to the investigation and evaluation of potentially adverse conditions at potential repository sites. The public comment period ended on October 7, 1993.

In anticipation of the results of a National Academy of Science (NAS) study undertaken in response to the EnPA, as well as Congressional activity with respect to the Nuclear Waste Policy Act of 1982, as amended, the Commission decided not to issue a final rule and directed f pd. ~ q/s/'li af t,3 F~l/1'/t/O

the NRC staff to withdraw the proposed rulemaking and reconsider the need for it when the legislative environment had stabilized. The purpose of this Federal Register notice is to announce the NRC's withdrawal of this proposed rule.

At present, the NRC staff has considered and is implementing a strategy for developing site-specific disposal regulations that would apply solely to the proposed geologic repository at Yucca Mountain, and is deferring the updating of 10 CFR Part 60 generic requirements to a later date. These site-specific regulations will be promulgated consistent with EnPA, which also requires the Environmental Protection Agency to issue radiation standards for a geologic repository at Yucca Mountain, based on and consistent with the 1995 findings and recommendations of the NAS. A proposed rule will be published for public comment by the end of the calendar year.

The NRC staffs strategy for developing the site-specific disposal regulations for Yucca Mountain can be found in a Commission Paper, designated SECY-97-300, that is dated December 24, 1997. This strategy was approved by the Commission in an SRM dated March 6, 1998. The Commission Paper, the SRM, and associated documents are available for public inspection and/or copying at the NRC Public Document Room located at 2120 L Street (lower level), NW, Washington, D.C., 20012-7082. Telephone: 202-512-2249.

.rr Dated at Rockville, Maryland, this 31-- day of August, 1998.

For the Nuclear Regulatory Commission.

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Secre 2

NUCLEAR WASTE REPOSITORY P&~T OFFICE NYE P.O. BOX 1767

• TONOPAH, NEVADA 89049 COUNIY (702) 482-8183

• FAX (i~2) ~-~~9 p J :z9 October 5, 1993 Samuel J. Chilk, Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 ATTN: Docketing and Service Branch RE: Proposed Rule: Disposal of High-Level Radioactive Waste and Geologic Repository; Investigation and Evaluation of Potentially Adverse Conditions

Dear Secretary Chilk:

T ::im rnd o~i11,e, on b~half Clf Nye County, Nevada, our comment:; on the propose<!

amendments to 10CFR 69.122 and 60.21 relating to the investigation and evaluation of potentially adverse conditions. These comments also apply to the accompanying draft regulatory analysis relating to this proposed rule.

While Nye County is not convinced of the necessity for the proposed rule, we understand the NRC staffs desire to clarify the Commission's existing policy and regulatory interpretations, particularly in view of the fact that the Center for Nuclear Waste Analysis has arrived at an interpretation of the relevant language of 10 CFR Part 60 which differs from that of the staff. As our enclosed comments indicate, we do not oppose the adoption of this proposed rule. We do see the potential for seriou regulatory uncertainty in the new language itself, however, and we suggest language to be incorporated into the new rule that would codify existing Commission policy with respect to the consideration of the engineered barrier system in licensing, and avoid an interpretation which is inconsistent with that long-MAY 1 o 1994

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2 Samuel J. Chilk, Secretary October 5, 1993 standing policy. Our proposed language reduces regulatory uncertainty, and I accordingly recommend it to you for your serious consideration.

Very truly yours, NYECOUNTY,NEVADA Les W. Bradshaw, Manager Nuclear Waste Repository Project Office cc: Phillip A. Niedzielski-Eichner, Governmental Dynamics, Inc.

Martin D. Mifflin, Mifflin and Associates Malachy R. Murphy, Lane, Powell, Spears and Lubersky Nick Stellavato, Nye County On-Site Geotechnical Representative William L. Offutt, Nye County Manager enclosure 93100404.ltr

NYE COUNTY'S COMMENTS ON PROPOSED RULE INVESTIGATION AND EVALUATION OF POTENTIALLY ADVERSE CONDITIONS The following constitute the comments of the Nye County Nuclear Waste Project Office on the NRC's proposed rule amending 10 CFR 60.21 and 10 CFR 60.122, relating to the clarification of assessment requirements for the siting criteria and performance objectives, and the investigation and evaluation of potentially adverse conditions. These comments should be considered directed at both the language and supplementary information of the proposed rule itself, as well as its accompanying draft regulatory analysis.

At the outset, Nye County is not convinced that the current language in 10 CFR Part 60, and particularly 10 CFR 60.122, is uncertain, and thus the proposed amendments themselves are not necessary. We do not share the CNWRA's interpretation, but rather agree with the staff's understanding of the Commission's intent in originally adopting 10 CFR Part 60, that individual demonstrations of performance for each of the potentially adverse conditions in 10 CFR 60.122 were not required. Nevertheless, because of the CNWRA's views, it is apparent that this language is indeed subject to differing interpretations. For that reason we understand and appreciate the NRC's desire to amend its rules to clarify its current policy that the adequacy of DOE's investigations and evaluations will be judged in terms of their significance to compliance with post-closure performance objectives. For that reason Nye County does not oppose the adoption of the proposed rule, subject to the adoption of the additional language which we suggest in these comments. In addition, separating provisions that deal with information presentation in the license application from the technical criteria, and moving those provisions to the section that defines the required contents of the license application makes sense, and accordingly, Nye supports that provision.

There is no doubt that removing the language that would require that each potentially adverse condition be "adequately investigated," and its effect "adequately evaluated" will result in controversy. Indeed, it already has. Nye County does not share in the view that such language is too ambiguous or ill-defined, and thus gives rise to an undesirable degree of regulatory uncertainty. There seems little doubt, for example, that by the conclusion of DOE's site characterization program, and the submission of the license application, the standards by which the "adequacy" of the investigations and evaluations will be measured will be clear to all parties.

Nye County understands, however, that the purpose of any investigation and evaluation, under whatever standard of "adequacy" one wantli, is to demonstrate clearly that the potentially adverse conditions do not compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste. Since that standard is clearly enunciated in the proposed new section 60.122(a)(2), Nye County has no objection to the proposed rule in that respect.

The language of proposed Section 60.2l(c)(ii)(C) does, however, cause some concern. The last sentence of that proposed subsection reads:

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The evaluations must demonstrate that, considering the potentially adverse conditions in combination with other characteristics of the site and design, the performance objectives relating to the isolation of the waste, as set out in §§ 60.122 and 60.113, will be met. (Emphasis supplied)

We are fearful that language, particularly the words "and design," could lead DOE, or some future NRC staff or Atomic Safety and Licensing Board, to conclude that the engineered barrier system could be used to overcome deficiencies in the site's natural ability to isolate waste because of the presence of one or more potentially adverse conditions. For that reason, Nye County suggests that the following language be added to the end of proposed 10 CFR 60.2l(c)(ii)(C):

The evaluations must further demonstrate that the engineered barrier system, and other design features, have not been used to overcome natural deficiencies in the ability of the site to isolate waste, and thus to meet the performance objectives relating to waste isolation.

2 LPOLY E:IOLYIMRM\10662MRM.MIS

BOB MILLER ROBERT R. LOUX Governor Executive Director CDCKUEO USNHC

• 93 OCT 12 P2 :44 AGENCY FOR NUCLEAR PROJECTS NUCLEAR WASTE PROJECT OFFICE Capitol Complex Carson City, Nevada 89710 Telephone: (702) 687-3744 Fax: (702) 687-5277 October 7, 1993 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Re: Proposed Rule 10 C.F.R. Part 60, Disposal of High-Level Radioactive waste In Geologic Repositories; Investigation And Evaluation Of Potentially Adverse conditions, 58 Fed. Reg. 36902, July 9, 1993

Dear Mr. Secretary:

The State of Nevada Agency for Nuclear Projects/Nuclear Waste Project Office has reviewed the subject proposed rule amendment, and our comments are as follows:

standard of Proof v. Content of Application:

The essential change proposed by the NRC amendments to 10 CFR 60.21 and 60.122 is a relocation of language from the standard of proof provisions of the rule to the content of application provisions of the rule. This is significant and problematic in the view of the State of Nevada.

The Nuclear Waste Policy Act requires that:

The Commission shall consider an application for a construction authorization for all or part of a repository in accordance with the laws applicable to such applications, except that the Commission shall issue a final decision approving or disapproving the issuance of a construction authorization not later than the expiration of 3 years after the date of submission of such application

• * * * [Emphasis supplied.]

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Secretary U.S. Nuclear Regulatory Commission October 7, 1993 Page 2 42 u.s.c. 10134(d). The "laws applicable to such applications" include the Atomic Energy Act of 1954 (42 u.s.c. 2011, et seq.);

the Energy Reorganization Act of 1974 (42 u.s.c. 4801, et seq.):

the National Environmental Policy Act (42 u.s.c. 4331, et seq.),

as truncated by section 114(f) of the Nuclear Waste Policy Act (42 u.s.c. 10134(f)); the Environmental Protection Agency's "generally applicable standards for protection of the general environment from offsite releases from radioactive material in repositories" (42 u.s.c. 10121(a); and the Nuclear Regulatory Commission's "technical requirements and criteria that it will apply, under the Atomic Energy Act of 1954 and the Energy Reorganization Act of 1974 in approving or disapproving (i) applications for authorization to construct repositories" (42 U.S.C. 10121(b), 10 CFR Part 60).

10 CFR 60 contains several sections which establish the standard which must be met in order for NRC to issue a construction authorization for a repository.

DOE must prove that there is "reasonable assurance" that the proposed repository will not present an "unreasonable risk to the health and safety of the public." 10 CFR 60.31, provides:

Upon review and consideration of an application and environmental report submitted under this part, the Commission may authorize construction if it determines:

(a) Safety. That there is a reasonable assurance that the types and amounts of radioactive materials described in the application can be received. possessed. and disposed of in a geologic repository operations area of the design proposed without unreasonable risk to the health and safety of the public. In arriving at this determination, the Commission shall consider whether:

(1) DOE has described the proposed geologic repository including but not limited to (i) the geologic, geophysical, geochemical and hydrologic characteristics of the site; (ii) the kinds and quantities of radioactive waste to be received possessed, stored, and disposed of in the geologic repository operations area; (iii) the principal architectural and engineering criteria for the design of the geologic repository

Secretary U.S. Nuclear Regulatory Commission October 7, 1993 Page 3 operations area; {iv) construction procedures which may affect the capability of the geologic repository to serve its intended function; and (v) features or components incorporated in the design for the protection of the health and safety of the public.

(2) The site and design comply with the performance objectives and criteria contained in Subpart E of this part * * * *

(c) Environmental. That, after weighing the environmental. economic. technical and other benefits against environmental costs and considering available alternatives, the action called for is issuance of the construction authorization, with any appropriate conditions to protect environmental values. [Emphasis supplied.]

DOE must also prove with "reasonable assurance" that the geologic setting of the repository will meet the performance objectives for isolation of the waste. 10 CFR 60.122 establishes a two pronged analysis 1 of favorable conditions (contained in 10 CFR 60.122(b)) and potentially adverse conditions {contained in 10 CFR 60.122{c)) as the methodology to meet the "reasonable assurance" standard:

(a) (1) A geologic setting shall exhibit an appropriate combination of the conditions specified in paragraph (b) of this section so that, together with the engineered barriers

[sic] system, the favorable conditions present are sufficient to provide reasonable assurance that the performance objectives relating to isolation of the waste [10 CFR 60.111-60.113) will be met.

(2) If any of the potentially adverse conditions specified in paragraph (c) of this section is present, it may compromise the ability of the geologic repository to meet 1

NRC itself calls the analysis required by 10 CFR 60.122 a "methodology for demonstrating that performance". 58 Fed. Reg. 36903, col. 3. We disagree with their following opinion that

" [ s Juch matters are ordinarily dealt with in procedural sections of the regulation". Id.

Secretary U.S. Nuclear Regulatory Commission October 7, 1993 Page 4 the performance objectives relating to isolation of the waste. In order to show that a potentially adverse condition does not so compromise the performance of the geologic repository the following must be demonstrated: [omitting list]. [Emphasis supplied. J Moving the proof elements from the standard of proof provisions of either 10 CFR 60.31 or 60.122 and relocating them to the content of application section (10 CFR 60.21), as the proposed rule would, potentially removes them from the open issues subject to litigation within a licensing proceeding, and from the potential appeal of those determinations, either within or outside the NRC. If the proof elements are in the content of application section only, the issue which must be litigated in the licensing proceeding, or on appeal, is whether the application is complete, not whether there is any reasonable assurance of safety. Leaving the proof elements within the standard of proof provision permits parties other than the applicant to present evidence on the same issue, whereas interested parties and intervenors cannot supplement the application's content.

Nevada maintains the position that it is inappropriate for the NRC to abdicate its role as judge of the safety of a proposed repository by removing any essential elements from the proof requirements established by the rule.

NRC's Purpose for Amending the Rule is Inappropriate:

In the preamble to the proposed rule changes, NRC states that the rule change is occasioned by a finding by the Center for Nuclear Waste Regulatory Analysis ("CNWRA") that the phrases "adequately investigated" and "adequately evaluated" contained in 10 CFR 60.122(a) (2) (i) and (ii) are "uncertain". In fact, the CNWRA found uncertainty in the phrases "adequately investigated" and "taking into account the degree of resolution of the investigations" contained in 10 CFR 60.122(a) (2) (i), 2 the phrase "not to affect significantly" contained in 10 CFR 2

see, Identification and Evaluation of Regulatory and Institutional Uncertainties in 10 CFR Part 60. Volume 2--

Identification, Center for Nuclear waste Regulatory Analysis, prepared for the Nuclear Regulatory Commission, February 1990, CNWRA 90-003, pp. B-82 and B-93.

Secretary U.S. Nuclear Regulatory Commission October 7, 1993 Page 5 60.122{a) (2) (iii) {A), 3 and the phrases "adequately evaluated" and "not likely to underestimate its effect" contained in 10 CFR 60.122{a) (2) (ii). 4 CNWRA also found the treatment of combinations of potentially adverse conditions in 10 CFR 60.2l{c) (1) (ii) {C) and 10 CFR 60.122 to be inconsistent and therefore uncertain. 5 In fact all these "uncertainties" address the scientist's typical discomfort with proving facts in a quasi-judicial setting and meeting a standard of approval or denial of the proposed activity. 6 CNWRA's essential concern is that, unless "uncertainties" are made clear, it will be necessary for the applicant to know the exact level of evidence and proof which will be required to meet the standard in order to avoid the "uncertainty". The inevitable result of removing the "uncertainty" in the manner suggested by the CNWRA is to abdicate the NRC's adjudicatory role in favor of DOE's project-development role.

The reasons stated by the CNWRA for its uncertainty about the application of language contained in the level of proof established by 10 CFR 60.122 include: 1) the change of the meaning of language in each unique application (B-86, B-87); 2) that the language must be read in conjunction with other regulatory provisions (B-87), and that the applicant know for sure in advance how much evidence is needed to support a finding of "reasonable assurance" (B-88). These stated reasons are obviously insufficient inasmuch as it gives away the NRC's judicial discretion and any intervenor's opportunity to challenge the sufficiency of evidence if the standard of proof is totally quantifiable in advance. From this perspective it is easy to 3

see Id., at p. B-84.

4see, Id., at pp. B-86 and B-91.

5see, Id., at p. B-103.

6 Indeed CNWRA also found "uncertainty" in the commonly understood concepts of "evidence", Id. at pp. B-112, B-116, B-118, B-122, B-124, and were troubled by the common adjectives "typical",

Id., at p. B-114, and "extreme", Id. at p. B-120. Nevada had this same concern regarding imprecise language and the potential subjective judgment consequent therefrom with the Secretary of Energy's site selection guidelines (10 CFR 960). But the NRC never asserted itself on that issue during its concurrence proceeding regarding 10 CFR 960.

Secretary U.S. Nuclear Regulatory Commission October 7, 1993 Page 6 see that the CNWRA's "uncertainties" are really not that at all but are instead a framework for reasoned minds to consider evidence in a quasi-judicial setting. There is, hence, no need to change the current language.

Furthermore, we find it difficult to comprehend the reason for the NRC's proposal to eliminate the phrases "adequate investigation" and "adequate evaluation" from 10 CFR Part 60 given the long history of usage of the same or similar phrases in 10 CFR Part 50, 10 CFR Part 51, and 10 CFR Part 100. For example, the lead paragraph in 10 CFR Part 100, App. A,Section IV "Required Investigations" is perhaps most relevant since it dates back to 1973 when the regulation was first promulgated. It was developed primarily by Earth Science professionals, and has survived a substantial number of precedent setting NRC licensing proceedings without significant challenge. The paragraph reads in part"* . . the geologic, seismic and engineering characteristics of a site and its environs shall be investigated in sufficient scope and detail to provide reasonable assurance that they are sufficiently well understood to permit an adequate evaluation of the proposed site, and to provide sufficient information to support the determinations required by these criteria and to permit adequate engineering solutions to actual or potential geologic seismic effects at the proposed site."

[Emphasis supplied.] There are a number of other uses of the term "adequate" throughout 10 CFR Part 100, App. A.

Some of The Proposed Language is has Merit:

Another reason NRC gives for changing the language contained in 10 CFR 60.122 is "to clarify our expectation that the evaluation of potentially adverse conditions should take into account the interaction of such conditions" and to ensure that "combined effects" are taken into account in meeting the performance objectives. NRC continues that although "the wording of the existing rule could be read to call for a more compartmentalized approach to the analysis of potentially adverse conditions, we view that construction as inappropriate." 58 Fed.

Reg. 36903, col. 3.

NRC consequently proposes to add the following language to 10 CFR 60.2l(c) (1) (ii) (C): "The evaluations must demonstrate that, considering the potentially adverse conditions in combination with other characteristics of the site and design, the performance objectives relating to the isolation of the waste, as set out in§§ 60.112 and 60.113, will be met." Despite our belief that the intent of the current rule is clear, Nevada could support this language, but in a different place. If adopted, it should be placed directly in 60.112 and 60.113 or remain in 60.122, those sections pertaining directly to standard

Secretary U.S. Nuclear Regulatory Commission October 7, 1993 Page 7 of proof. In the proposed location within the rule, DOE's failure to make the required demonstration is merely a failure to file a complete application. Rather the failure to make this demonstration should be reason to deny the application.

Some of The Proposed Language is Objectionable:

NRC proposes to replace the term "adequately investigated" by requiring an analysis of each potentially adverse condition which will "demonstrate either its absence or the extent to which its presence may have been underestimated or undetected, taking into account the degree of resolution achieved by the investigations." (Proposed 10 CFR 60.21(c) (1) (ii) (B)).

NRC also proposes to replace the term "adequately evaluated" by requiring that "evaluations [of the performance of the proposed geologic repository] shall consider all of the potentially adverse conditions and favorable conditions enumerated in§ 60.122 except those that have been determined to be absent." (Proposed 10 CFR 60.2l(c) (1) (ii) (B)).

The effect of these two changes is to transfer the evaluation of the physical evidence from the NRC to the DOE, again abdicating NRC's quasi-judicial role. It is not logical that DOE will be able to (or want to) demonstrate the extent to which it had underestimated or failed to detect a physical fact.

As a project proponent, DOE will never want to present evidence which will work against approval of its application.

Underestimated or undetected facts merely raise questions which potentially undermine "reasonable assurance". Similarly, DOE will likely choose to determine a potentially adverse condition to be absent or a favorable condition to be present, and therefore leave it out of its evaluation, in an attempt to persuade NRC of its "reasonable assurance".

Nevada opposes these language changes.

Conclusion:

From our review of the subject proposed rule amendment, we have concluded:

1. The proposal greatly diminishes the NRC's role as judge of the safety of a proposed repository by removing essential elements from the proof requirements of the current rule.

Secretary U.S. Nuclear Regulatory Commission October 1~, 1993 Page 8 i

2. The NRC's basis for amending the rule is inappropriate, and its purpose is inconsistent with long-standing NRC regulatory precedent.

3. While some of the proposed regulatory language may have merit, it is unnecessary for clarifying the NRC's regulatory intent. And some of the proposed language is objectionable in that it reduces the scope of proof necessary for NRC judgment regarding safety.

4. And, finally, it is not necessary to amend the rule as proposed at this tiine, since there is no pressing immediate or near-term application of the elements under review that would materially affect on-going repository site characterization. The current Congressionally mandated revision of EPA and NRC repository regulation, specific to a Yucca Mountain repository, will result in a regulatory review of 10 CFR 60 within the next few years, and it would be appropriate to undertake a comprehensive review of the regulations at that time, rather than proposing individual amendments in the interim.

We appreciate the opportunity to review and comment on the proposed amendments to 10 CFR 60, and look forward to your consideration and responses to our comments.

Sincerely,

~~~ Robert / R. Loux Executive Director RRL/sjc

701 Pennsylvania Avenue, NW Washington D.C. 20004-2696 Telephone 202-508-5550

• 93 OCT - 8 Pl2 :20 EDISON ELECTRIC DAVID L.SWANSON INSTITUTE _ ~- , .. Senior Vice President, Energy

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• and Environmental Activities

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October 7, 1993 Mr. Samuel J. Chilk Secretary U.S. Nuclear Regulatory Commission Mail Stop 16G15 Washington, D.C. 20555 Attention: Docketing and Service Branch

Subject:

Proposed Rule -- Disposal of High-Level Radioactive Wastes In Geologic Repositories; Investigation and Evaluation of Potentially Adverse Conditions (58 Fed. Reg. 36,903)

Dear Mr. Chilk:

These comments are being submitted to the Nuclear Regulatory Commission (NRC) by the Edison Electric Institute/Utility Nuclear Waste and Transportation Program (EEI/UWASTE). EEI/UWASTE supports the intent of the proposed rule, which is to clarify NRC regulations concerning the evaluation of repository sites.

However, as discussed below, the specific wording of the regulations, as proposed, creates problems requiring rectification.

EEi is the association of the nation's investor/owned utilities. Its members generate approximately 78 percent of the nation's electricity. EEI/UWASTE is a separately-funded activity within EEi and represents the vast majority of electric utilities with nuclear energy programs. EEI/UWASTE takes action necessary to ensure that safe, environmentally sound, publicly acceptable, cost-effective radioactive waste management and disposal and nuclear material transportation systems are maintained and developed in a timely manner.

The rulemaking notice would make certain changes to 10 CFR §§ 60.21 and 60.122. According to the notice, the proposed revisions attempt to make clear that the adequacy of a license applicant's investigations and evaluations will be MAY 1 o 1994 Acknowledged by card ........ N .............. eu.......

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Mr. Samuel J. Chilk October 7, 1993 Page 2 judged in terms of their significance to compliance with post-closure performance objectives. Further, the proposed rule would separate provisions in the regulations dealing with the presentation of information in the license application, from those prescribing the technical criteria which must be met. EEI/UWASTE has no objection to the intent of the proposed revisions. However, as indicated in the following paragraphs, the proposed rewording of sections 60.21 and 60.122 is deficient in two respects and requires modification.

First, as revised, section 60.21 would require analyses to determine the degree to which each favorable condition and potentially adverse condition enumerated in section 60.122 has been characterized and has been found to be present. It would also require that, "For each potentially adverse condition, the analysis shall demonstrate either its absence or the extent to which its presence may have been underestimated or undetected, taking into account the degree of resolution achieved by the investigations."

To demonstrate either the absence of a potentially adverse condition or the extent to which its presence may have been underestimated or undetected, however, calls for proving a negative, which is impossible. Accordingly, the above-quoted sentence should be eliminated. Adequate consideration of potentially adverse conditions is assured through the quality of site characterization prescribed by Subpart G "Quality Assurance" and other portions of 10 CFR Part 60.

Second, as proposed, section 60.122(a) (2) prescribes that, "The presence of potentially adverse conditions must not compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste."

This provision, however, might be misinterpreted and taken to mean that any potentially adverse condition resulting in any reduction in performance objectives relating to waste isolation -- regardless of how small and whether or not such objectives, as set out in sections 60.112 and 60.113, would be met -- would render a site unacceptable. Accordingly, proposed section 60.122(a)(2) should be eliminated. At the minimum, it should be revised to read:

Mr. Samuel J. Chilk October 7, 1993 Page 3 11 (2) The presence of potentially adverse conditions must not significantly affect the ability of the geologic repository to meet the performance objectives relating to isolation of the waste, as set out in §§ 60.112 and 60.113. 11 EEI/UWASTE hopes that these comments are helpful. If there are any questions, or if additional information would be helpful, please do not hesitate to give me a call.

Sincerely, DLS/mag

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Department of Energy GOCKE:~ =:;

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Washington, DC 20585 USNi C OCT 4 1993 Secretary U.S. Nuclear Regulatory Commission Attention: Docketing and Service Branch Washington, DC 20555

Subject:

U.S. DEPARTMENT OF ENERGY COMMENTS ON U.S. NUCLEAR REGULATORY COMMISSION PROPOSED RULE ON DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES; INVESTIGATION AND EVALUATION OF POTENTIALLY ADVERSE

- CONDITIONS Gentlemen:

Enclosed are a hardcopy and a disc of the U.S. Department of Energy's (DOE) comments on the U.S. Nuclear Regulatory Commission's (NRC) proposed rule on "Disposal of High-Level Radioactive Wastes in Geologic Repositories; Investigation and Evaluation of Potentially Adverse Conditions," published for public comment on July 9, 1993, (FR 36902).

We are pleased that you have reaffirmed your historic position that potentially adverse conditions are to be assessed if present and that reasonable assurance is the standard for determining whether post-closure performance objectives have been met. We support your d e sire to clarify 10 CFR Part 60 but f ee l that, to achieve your objective, you have proposed changes to its requirements that may, in fact, introduce rather than eliminate regulatory uncertainty or that may be interpreted as b e ing inconsistent with your historic position. Having reviewed the proposed rule and relevant background material, we therefore suggest that the proposed rule be changed for the reasons indicated in the enclosure and propose changes to the rule that we believe are consistent with your original intent.

MAY 1 o 1994 *~

Acknowledged by card ***HNHHH*m-**-~

D"*:t ,;GTION c:- TARY Or N

We appreciate the opportunity to comment on this proposed rule.

If you have any questions about our comments, contact Corinne Macaluso of my staff at 202-586-2837.

Sincerely, l_EA.,.,,

Dwight i.

ti£ SLJ<N' Shelor Associate Director Office of Systems and Compliance Office of Civilian Radioactive Waste Management

Enclosures:

As stated cc (w/hardcopy enclosure):

C. Gertz, YMPO T. J. Hickey, Nevada Legislative Committee R. Loux, State of Nevada (w/disc also)

D. Bechtel, Las Vegas, NV Eureka County, NV Lander County, Battle Mountain, NV P. Niedzielski-Eichner, Nye County, NV

w. Offutt, Nye County, NV L. Bradshaw, Nye County, NV C. Schank, Churchill County, NV F. Mariani, White Pine County, NV V. Poe, Mineral County, NV J. Pitts, Lincoln County, NV J. Hayes, Esmeralda County, NV B. Mettam, Inyo County, CA

ENCLOSURE U.S. Department of Energy Comments On the U.S. Nuclear Regulatory Commission's Proposed Rulemaking On "Disposal of High-Level Radioactive Wastes In Geologic Repositories; Investigation and Evaluation of Potentially Adverse Conditions" 58 Fed. Reg. 36,902 (July 9, 1993)

§60.21(c)(l)(ii)(B)

NRC's current rule in 10 CFR Part 60.2l(c)(l)(ii)(B) requires that the assessment of the site shall contain Analyses to determine the degree to which each of the favorable and potentially adverse conditions, if present, has been characterized, and the extent to which it contributes to or detracts from isolation .. .Potentially adverse conditions shall be investigated outside of the controlled area if they affect isolation within the controlled area. (emphasis added)

NRC's proposed rule in 10 CFR Part 60.2l(c)(l)(ii)(B) would require Analyses to determine the degree to which each favorable condition and potentially adverse condition enumerated in

§60.122 has been characterized and found to be present. For each potentially adverse condition, the analysis shall demonstrate either its absence or the extent to which its presence may have been underestimated or undetected, taking into account the degree of resolution achieved by the investigations ... Potentially adverse conditions shall be investigated outside the controlled area if they may affect isolation within the controlled area. (emphasis added)

DOE believes that this proposed rule would be inconsistent with NRC's historic position and, in addition, would introduce regulatory uncertainty for the following reasons:

Taken together with the requirement in the proposed §60.2l(c)(l)(ii)(C) that " ... evaluations shall consider all of the potentially adverse conditions and favorable conditions enumerated in

§60.122 except those that have been determined to be absent ... "the proposed rule, rather than requiring determination of the presence of a potentially adverse condition, would require determination of absence. Of concern and relevance to whether the proposed rule is consistent with NRC's historic position is whether NRC would consider these determinations to be equivalent.

That NRC's proposal is concerned with reducing a number of the uncertainties considered in 1

CNWRA-93-003, "Identification and Evaluation of Regulatory and Institutional Uncertainties in 10 CFR Part 60," is relevant to this question. In that report, the Center for Nuclear Waste Regulatory Analyses (CNWRA) discussed whether the references in §60.122 to "evidence" of certain potentially adverse conditions, specifically Nos. 15, 16, 18, and 19, referred to the "evidence" or to the conditions themselves. The CNWRA concluded, in Appendix B, that when these conditions are read together with §60.122(a)(2), which provides that if a potentially adverse condition is present the ability of the site to meet its performance objectives may be compromised, no uncertainty is present. The CNWRA therefore concluded that evidence of a given condition indicates its presence and a lack of evidence of a condition necessarily indicates the condition is not present and no further analyses need be conducted.

If NRC considers lack of evidence to be equivalent to absence, then the proposed rule would be consistent with its historic position. The proposed rule could, however, be interpreted as a requirement of proof of absence rather than demonstration of lack of evidence of the presence of a condition. Such interpretation by NRC would impose a very different and unintended requirement that might be impossible to meet. DOE therefore believes that clarification of this part of the rule would be appropriate.

With respect to the proposed requirement that for each potentially adverse condition the analysis shall demonstrate the extent to which its presence may have been underestimated or undetected, DOE notes that such conditions could also be present to an extent that is well understood or be overestimated intentionally for conservatism. The language of the proposed rule should take such considerations into account.

The proposed requirement that " ... Potentially adverse conditions shall be investigated outside the controlled area if they may affect isolation within the controlled area" would, DOE believes, introduce rather than eliminate regulatory uncertainty and could require the costly and time consuming evaluation of potentially adverse conditions outside the controlled area that are neither relevant nor material to the finding that the post-closure performance objectives relating to the isolation of radioactive waste has been satisfied. Because it would include the words may affect, the proposed requirement would be unbounded and inconsistent with NRC's intent to clarify the rule. It is also pertinent to note that, as a consequence, the proposed requirement unfortunately meets the test for regulatory uncertainty set forth in CNWRA 90-003 that " ... a regulation is said to contain Regulatocy Uncertainty when there is lack of clarity in the quoted statement, when an essential requirement has been omitted, or when requirements which either detract from the regulatory program or do not contribute to the regulatory program are included in the regulation." DOE therefore believes that clarification of this part of the rule in a manner that would provide a stronger causal nexus between the condition under consideration and the likelihood that it would significantly affect waste isolation is warranted.

To preclude misinterpretation and the introduction of regulatory uncertainty, DOE suggests that NRC affirm that its intent is indeed clarification and not the imposition of a substantively 2

different rule. In support of such affirmation, DOE further suggests that NRC replace the language in the proposed rule with the following text:

Proposed Text for §60.21(c)(l)(ii)(B)

Analyses to determine the degree to which each favorable condition and potentially adverse condition enumerated in

§60.122 has been characterized and found to be present. For each potentially adverse condition, the analysis shall demonstrate the extent to which it may be present, taking into account the degree of resolution achieved by the investigations. For this purpose, investigations shall extend from the surface to a depth sufficient to determine critical pathways for radionuclide migration from the underground facility to the accessible environment. Potentially adverse conditions shall be investigated outside the controlled area if they are likely to significantly affect isolation within the controlled area.

§60.21(c)(l)(ii)(C)

NRC's current rule in 10 CFR Part 60.2l(c)(l)(ii)(C) requires that the assessment of the site shall also contain An evaluation of the performance of the proposed geologic repository for the period after permanent closure, assuming anticipated processes and events, giving the rates and quantities of releases of radionuclides to the accessible environment as a function of time and a similar evaluation which assumes the occurrence of unanticipated processes and events. (emphasis added)

NRC's proposed rule in this same section would require An evaluation of the performance of the proposed geologic repository for the period after permanent closure, assuming anticipated processes and events, giving the rates and quantities of releases to the accessible environment as a function of time; and a similar evaluation that also assumes the occurrence of unanticipated processes and events. The evaluations shall consider all of the potentially adverse conditions and favorable conditions enumerated in §60.122 except those that have been determined to be absent. In considering any such potentially adverse condition, assumptions should be used that are not likely to underestimate its effects. The evaluations must demonstrate that, considering the potentially adverse conditions in combination with other 3

characteristics of the site and design, the performance objectives relating to the isolation of the waste, as set out in §§60.112 and 60.113, will be met. (emphasis added)

The proposed rule differs from the current rule in its requirements for evaluation of releases to the accessible environment, determination of the absence of potentially adverse conditions, and demonstration of compliance with the performance objectives set out in both §§60.112 and 60.113. DOE believes that these differences are significant and sufficient to warrant changes in text before the rule is promulgated.

The proposed requirement for evaluation of releases instead of releases of radionuclides to the accessible environment is clearly a requirement that is more global than that embodied in the current rule. Under §l21(b)(l)(C) of the Nuclear Waste Policy Act (NWPA), NRC was authorized to promulgate requirements and criteria not inconsistent with comparable standards to be promulgated by the Environmental Protection Agency under subsection (a).

Those standards, as set forth in §12l(a), are to be "generally applicable standards for protection of the general environment from offsite releases from radioactive material in repositories." (emphasis added) The proposed requirement is, in addition, inconsistent with the text of the proposed §60.2l(c)(l)(ii)(B) which calls for investigations extending "from the surface to a depth sufficient to determine critical pathways for radioactive nuclide migration from the underground facility to the accessible environment." (emphasis added)

It would appear, therefore, that NRC's concern, consistent with its statutory authority, is really with releases of radionuclides, not with all releases, and the text of the rule as promulgated should reflect this.

DOE's concern about the potential requirement for the determination of the absence of a potentially adverse condition is discussed above. That the text of the proposed

§60.2l(c)(l)(ii)(B) is inconsistent with NRC's intent may be indicated by the text in the Background section of NRC's proposal at 58 Fed. Reg. 36,904 (July 9, 1993) which states that "Under §60.2l(c)(l)(ii)(B), the applicant would still be required to carry out the investigations needed to determine whether or not a potentially adverse condition may be present." DOE believes that the text of this part of the rule should be modified to reflect NRC's intent.

With respect to the proposed requirement for demonstration of compliance with the performance objectives set out in both §§60.112 and 60.113, DOE notes that this requirement (and the related requirement in the proposed §60.122(a)(l)) would be inconsistent with NRC's intent as set forth in the Summary section of its proposal at 58 Fed.

Reg. 36,902 (July 9, 1993) in which NRC states that "The proposed revisions attempt to make clear that the adequacy of a license applicant's investigations and evaluations will be judged in terms of their significance to compliance with "post-closure performance objectives." (emphasis added) NRC expanded on this intent in the Background section of its proposal at pp. 36,903 and 36,904 in stating that "DOE would need to demonstrate that the performance objectives would be met, taking into account the presence of potentially 4

adverse conditions," that "It is also appropriate to clarify our expectations that the evaluation of potentially adverse conditions should take into account the interaction of such conditions,"

that "The very reason for requiring consideration of potentially adverse conditions is to ensure that the perfonnance objectives will be met and this cannot be accomplished if combined effects are not taken into account," and that "Instead of setting out a methodology for demonstrating that a potentially adverse condition does not compromise the geologic repository's ability to meet the perfonnance objectives relating to isolation of waste, this portion of the rule would simply declare that the presence of potentially adverse conditions must not so compromise repository perfonnance."

That the proposed requirement would be inappropriate is also illustrated by the fact that the groundwater travel time requirement of §60. ll 3(a)(2) is clearly and as stated in the rule a pre-waste-emplacement requirement, not a post-closure perfonnance requirement. The tenn pre-waste emplacement clearly refers to the period of time before waste is placed in a repository and pre-waste emplacement groundwater travel time must therefore mean the groundwater travel time before waste is emplaced, not post-closure. In addition, the siting criteria include conditions such as adverse human activities (§§60.122(a)(2)(i) - (iii) and 60.122(c)(2)) and climatic changes (§60.122(c)(6) that could only occur long after waste has been emplaced. Further, the siting criteria in §60.122 include conditions that might occur rarely, if at all. The engineered barrier system, according to §60. l 13(a)(l), is to be designed assuming anticipated processes and events. By definition, as set forth in §60.2, such events are to include only natural processes and events that are reasonably likely to occur. They therefore exclude rare events and events attributable to human activity. These conditions are such that the siting criteria in §60.122 are inappropriate for use either in designing the engineered barrier system or in calculating pre-waste emplacement groundwater travel time.

Given the concerns noted above, the continuing reference in the proposed rule to the requirement for demonstrating compliance with the perfonnance objectives set out in both

§§60.112 and 60.113, rather than clarifying the rule, would create confusion. To provide the reasonable assurance that the perfonnance objectives relating to isolation of the waste will be met, as NRC intends, requires, as stated in the Background section of NRC's proposal at

p. 36,904, that "evaluations are to be undertaken in combination" and that "the effect of a particular potentially adverse condition would not be studied in isolation ... " This can be accomplished only by taking the total systems approach embodied in a demonstration of compliance with the requirements of §60.112. For all of these reasons DOE believes that the appropriate requirement would be a requirement for demonstration of compliance with the perfonnance objectives set forth in §60.112 alone.

5

• DOE therefore suggests that NRC replace the language in the proposed rule with the following text:

Proposed Text for §60.21(c)(l)(ii)(C)

An evaluation of the performance of the proposed geologic repository for the period after permanent closure, assuming anticipated processes and events, giving the rates and quantities of releases of radionuclides to the accessible environment as a function of time; and a similar evaluation that also assumes the occurrence of unanticipated processes and events. The evaluations shall consider the potentially adverse conditions, if present, and appropriate favorable conditions enumerated in

§60.122. In considering any such potentially adverse condition, assumptions consistent with the degree of resolution achieved by the investigation of the condition should be used that are not likely to underestimate its effects. The evaluations must demonstrate that, considering the potentially adverse conditions in combination with other characteristics of the site and design, the performance objectives relating to the isolation of the waste, as set out in §60.112, will be met.

§60.122(a)(l)

For the reasons set forth above, DOE suggests that NRC replace the language in the proposed rule with the following text:

Proposed Text for §60.122(a)(l)

A geologic setting shall exhibit an appropriate combination of the conditions specified in paragraph (b) of this section so that, together with the engineered barrier system, the favorable conditions present are sufficient to provide reasonable assurance that the performance objectives relating to isolation of the waste, as set out in §60.112, will be met.

§60.122(a)(2)

DOE notes that in this section as proposed the potentially adverse conditions are not specified whereas in the proposed §60.122(a)(l) the text refers to the specific conditions that are relevant. In the interest of clarity, DOE suggests that the following language be included in the rule:

Proposed Text for §60.122(a)(2) 6

The presence of potentially adverse conditions, specified in paragraph (c) of this section, must not compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste.

Summary DOE supports the efforts of NRC to clarify its requirements in 10 CPR Part 60 by completely separating the provisions concerned with the presentation of information in the license application from the technical criteria in Subpart E. DOE is pleased that NRC, in its proposal, reaffirmed its historic position that potentially adverse conditions are to be assessed only if present and clearly stated that reasonable assurance is the standard for determining whether performance objectives have been met.

DOE notes, however, that NRC's proposal includes changes to its requirements that appear to be inconsistent with its intent and historic position and that may, in fact, introduce rather than eliminate regulatory uncertainty. DOE, having reviewed NRC's proposal and relevant background material, believes that the following text would be appropriate for inclusion in the rule:

Proposed Text for §60.21(c)(l)(ii)(B)

Analyses to determine the degree to which each favorable condition and potentially adverse condition enumerated in

§60.122 has been characterized and found to be present. For each potentially adverse condition, the analysis shall demonstrate the extent to which it may be present, taking into account the degree of resolution achieved by the investigations. For this purpose, investigations shall extend from the surface to a depth sufficient to determine critical pathways for radionuclide migration from the underground facility to the accessible environment. Potentially adverse conditions shall be investigated outside the controlled area if they are likely to significantly affect isolation within the controlled area.

Proposed Text for §60.21(c)(l)(ii)(C)

An evaluation of the performance of the proposed geologic repository for the period after permanent closure, assuming anticipated processes and events, giving the rates and quantities of releases of radionuclides to the accessible environment as a function of time; and a similar evaluation that also assumes the occurrence of unanticipated processes and events. The 7

evaluations shall consider the potentially adverse conditions, if present, and appropriate favorable conditions enumerated in

§60.122. In considering any such potentially adverse condition, assumptions consistent with the degree of resolution achieved by the investigation of the condition should be used that are not likely to underestimate its effects. The evaluations must demonstrate that, considering the potentially adverse conditions in combination with other characteristics of the site and design, the performance objectives relating to the isolation of the waste, as set out in §60.112, will be met.

Proposed Text for §60.122(a)(l)

A geologic setting shall exhibit an appropriate combination of the conditions specified in paragraph (b) of this section so that, together with the engineered barrier system, the favorable conditions present are sufficient to provide reasonable assurance that the performance objectives relating to isolation of the waste, as set out in §60.112, will be met.

Proposed Text for §60.122(a)(2)

The presence of potentially adverse conditions, specified in paragraph (c) of this section, must not compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste.

8

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• NL I OCT 4 1993 Mr. Samuel Chilk Secretary of the Commission Nuclear Regulatory Commission Attention: Docketing and Service Branch Washington, DC 20555

Dear Mr. Chilk,

In accordance with its responsibilities under Section 309 of the Clean Air Act, the U.S. Environmental Protection Agency has reviewed the Nuclear Regulatory Commission's proposed rule for the disposal of high-level radioactive wastes in geologic repositories; investigation and evaluation of potentially adverse conditions, published in the Federal Register July 9, 1993, and has no comments.

We appreciate the opportunity to review the proposed regulation. If you have any questions, please call me on (202) 260-5053 or have your staff contact Ms. Susan Offerdal (202) 260-5059.

sµ I~

Richard E . Sanderson Director Office of Federal Activities Acknowledged by card .. ~~-~***:..~*.2::.4__ @ Printed on Recycled Paper

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• 93 JUL 29 P4 :08 July 26, 1993 Secretary of the Commission Nuclear Regulatory Commission Washi ngton, D.C. 20555 Attn: Docketing and Service Branch

Dear Secretary:

Thank you for the opportunity to comment on your proposal to amend your regulations for high-level radioactive waste repositories to clarify how the agency will evaluate compliance with siting requirements.

The regulations s hould make it clear t hat the geology should be capable alone to safely isolate the waste for ten thousand years.

This is why scientists originally preferred the waste be buried in a salt or a granite strata. The scientists c hose the site of the Waste Isolation Pilot Project in New Mexico because in salt there is very little reliance on engineered barriers.

The regulations should make it very clear that engineered barriers shall not be re l ied upon to overcome a defect in a geologic site.

Common sense tells one that no site should be located in earthquake zones in California or Nevada.

Charles Hollister, Director of the Woods Hole Institute said on the TV show - "Firing Line" several years ago that waste could be disposed of in the Pacific Ocean. It would take only $5,000,000 to prove his contention. Engineered barriers would not be relied upon.

Sincerely,

~~ ?&-n~~ -

Frank Clements

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NUCLEAR REGULATORY COMMISSION , *r 10 CFR Part 60 RIN 3150-AE40 Disposal of High-Level Radioactive Wastes in Geologic Repositories;

- Investigation and Evaluation of Potentially Adverse Conditions AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Commission proposes to clarify its regulations with respect to the consideration of certain defined geologic and

- other conditions that, if present, are potentially adverse to the ability of a geologic repository to meet the prescribed performance objectives with respect to isolation of high-level radioactive waste. The proposed revisions attempt to make clear that the adequacy of a license applicant's investigations and evaluations will be judged in terms of their significance to compliance with post-closure performance objectives. In addition, provisions that deal with information presentation in the license application would be completely separated from the technical criteria and moved to the section that defines the required contents of the license application. l'1 \qJ p~-1

2 DATES: Comments must be submitted on or before [Insert date 90 days after date of publication in the FEDERAL REGISTER.]

Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Attn: Docketing and Service Branch.

FOR FURTHER INFORMATION CONTACT: Mark S. Delligatti, Division of High-Level Waste Management, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Rockville, Maryland 20852, telephone (301) 504-2430.

SUPPLEMENTARY INFORMATION: As reflected in the Nuclear Waste

- Policy Act of 1982, as amended, the Nuclear Regulatory Commission exercises licensing and related regulatory authority with respect to geologic repositories that are to be constructed and operated by the U.S. Department of Energy (DOE} for the disposal of high-level radioactive waste. The Commission's regulations pertaining to such geologic repositories appear at 10 CFR Part 60. The Commission has lately been engaged, with the assistance of its federally-funded research and development center (the Center for Nuclear Waste Regulatory Analyses, or "CNWRA"), in a review of

3 the requirements of Part 60, with particular attention to any matters that may be ambiguous or inconsistent with other expressions of its regulatory policy. The results of CNWRA's review were reported in CNWRA 90-003, "Identification and Evaluation of Regulatory and Institutional Uncertainties in 10 CFR Part 60." The proposal that is presented by this notice deals with a matter that was brought to light by this review.

Background

To place the issue at hand in context, it would be useful to describe generally the principal features of Part 60.

1. Before construction of the repository, DOE is required to obtain a "construction authorization" from NRC (10 CFR 60.3(b)).

2. DOE's license application, which is to be submitted when it seeks construction authorization, must contain the information described in a detailed section on "Content of application" (10 CFR 60.21).

3. Upon consideration of DOE's application, the Commission may authorize construction, considering whether required information has been submitted and whether the site and design comply with the Technical Criteria (10 CFR 60.3l(a)).

4

4. The "Technical Criteria" in 10 CFR Part 60, Subpart E include, among other things, certain performance objectives (10 CFR 60.111-60.113) as well as siting criteria (10 CFR 60.122) and design criteria (10 CFR 60.130-134).

The issues to be addressed concern: (1) the meaning of two provisions of the siting criteria, particularly as they may relate to the performance objectives; (2) the way individual potentially adverse conditions must be considered; and (3) the appropriateness of moving, from the siting criteria to the content of application section, those requirements that deal with information to be provided by DOE, including the provisions of the siting criteria described above.

The siting criteria include a listing (in 10 CFR 60.122(b))

of certain "favorable conditions" and also (in 10 CFR 60.122(c))

- of certain "potentially adverse conditions." The significance of these conditions is that they may affect the performance of the repository in isolating any emplaced waste -- i.e., inhibiting the transport of radioactive materials from emplaced waste so amounts and concentrations entering the environment will be kept within prescribed limits.

CNWRA's review of the regulation did not identify any regulatory uncertainty with respect to the treatment of favorable conditions. The treatment of potentially adverse conditions was

5 viewed, however, as being unclear. The regulation appropriately notes that if any of the potentially adverse conditions is present, it may compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste. 1 It then goes on to specify ways in which it can be demonstrated that such a condition does not so compromise the performance of the repository. For the demonstration to meet the requirements of the rule, the potentially adverse condition must have been "adequately investigated" and its effect must have been "adequately evaluated."

Each of these terms gives rise to a regulatory uncertainty.

Specifically, the issue concerns the standard by which the "adequacy" of the investigation and evaluation is to be measured:

Is the proper standard that which is relevant and material to judging whether the performance objectives relating to isolation 1

See Staff Position 60-002, "The Meaning of the Phrase

'Performance Objectives Relating to Isolation of the Waste, '" where it was concluded, on the basis of the rulemaking record for 10 CFR Part 60, that the subject phrase (in 10 CFR 60.122) refers to the performance objectives set out in 10 CFR 60.112, "Overall Performance Objective for the Geologic Repository after Permanent Closure," and 10 CFR 60.113, "Performance of Particular Barriers after Permanent Closure," but does not ref er to the performance objectives set out in 10 CFR 60.111, "Performance of the Geologic Repository Operations Area through Permanent Closure."

Availability of this staff position was noted at 55 FR 33565; August 16, 1990.

6 of the waste have been met, or is it some other standard, (and if so, *,.; hat standard) ? 2 In addition, the CNWRA interpreted 10 CFR 60.122(a) (2) to require analyses of the effect of each potentially adverse condition on performance and therefore, 2

The full text of the pertinent regulation, 10 CFR 60.122(a),

reads as follows:

(a) (1) A geologic setting shall exhibit an appropriate combination of the conditions specified in paragraph (b) of this section so that, together with the engineered barriers [sic] (barrier] system, the favorable conditions present are sufficient to provide reasonable assurance that the performance objectives relating to isolation of the waste will be met.

(2) If any of the potentially adverse conditions specified in paragraph (c) of this section is present, it may compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste. In order to show that a potentially adverse condition does not so compromise the performance of the geologic repository the following must be demonstrated:

(i) The potentially adverse human activity or natural condition has been adequately investigated, including the extent to which the condition may be present and still be undetected taking into account the degree of resolution achieved by the investigations; and (ii) The effect of the potentially adverse human activity or natural condition has been adequately evaluated using analyses which are sensitive to the potentially human activity or natural condition and assumptions which are not likely to underestimate its effect; and (iii) (A) The potentially adverse human activity or natural condition is shown by analysis pursuant to paragraph (a) (2) (ii) of this section not to affect significantly the ability of the geologic repository to meet the performance objectives relating to isolation of the waste, or (B) The effect of the potentially adverse human activity or natural condition is compensated by the presence of a combination of the favorable characteristics so that the performance objectives relating to isolation of the waste are met, or (C) The potentially adverse human activity or natural condition can be remedied. (Emphasis added.)

7 10 CFR 60.122(a) (2) constitutes a separate regulatory requirement independent of the performance objectives in 10 CFR 60.112 and 10 CFR 60.113. The CNWRA concluded that even if compliance was demonstrated with 10 CFR 60.112 and 10 CFR 60.113, additional demonstration of compliance would be necessary to address the potentially adverse conditions listed in 10 CFR 60.122(c).

Discussion The Commission believes that its intention has been consistent and manifest throughout the rulemaking process. The Commission has endeavored to establish a set of regulations that would facilitate a judgment, in accordance with the Atomic Energy Act, of whether the proposed disposal of high-level waste in a geologic repository would create any unreasonable risk to the health and safety of the public. Although certain requirements may be stated in unqualified terms, we have noted that we do not expect that complete assurance that they will be met can be presented. A reasonable assurance, on the basis of the record before the Commission, that the objectives and criteria will be met, is the general standard that is required. In particular, proof of the future performance of engineered barrier systems and the geologic setting over time periods of many hundreds or many thousands of years is not to be had, in the ordinary sense of the word. What is required is reasonable (not complete) assurance that the outcome will be in conformance with those objectives and criteria. The Commission has stated that demonstration of

8 compliance will rely on data from accelerated tests and predictive models that are supported by such measures as field and laboratory tests, monitoring data, and natural analog studies. 10 CFR 60.l0l(a) (2)

Reasonable assurance that the outcome will be in conformance with the stated objectives and criteria represents a judgment that the overall performance of the geologic repository, and the performance of particular subsystems, would achieve specified levels of radionuclide containment and isolation, coupled with an expectation that certain design and quality assurance features would be incorporated so as to enhance confidence that such performance would be achieved. Concern with potentially adverse conditions was spelled out clearly: it was to assure that they would be " ... assessed in order to assure that they will not compromise the ability of the geologic repository to meet the performance objectives [relating to isolation of the waste]."

(Emphasis added.) 48 FR 28194, 28201, June 21, 1983 (final rulemaking) .

It was our inclusion in the technical criteria of provisions that relate not to the performance of the repository, but to methodology for demonstrating that performance that gave rise to the regulatory uncertainty identified by CNWRA. Such matters are ordinarily dealt with in procedural sections of the regulations, and in particular those sections that define the requirements for

9 the content of license applications, and should have been treated in like manner in 10 CFR Part 60. Had this been done, there would be no uncertainty. The rule would then have been a straightforward reflection of the Commission's intent. DOE would need to demonstrate that the performance objectives would be met, taking into account the presence of potentially adverse conditions. DOE would not have to demonstrate, as well, that there had been an "adequate investigation" or "adequate evaluation" above and beyond what might be needed to show, with reasonable assurance, that the performance objectives related to isolation of the waste would be met. We do, in fact, anticipate that quite thorough investigations will be undertaken and that very sophisticated evaluations will be needed, but the measure to be applied is only that which is relevant and material to a finding that the performance objectives have been satisfied.

It is also appropriate to clarify our expectation that the evaluation of potentially adverse conditions should take into account the interaction of such conditions. Indeed, it would be inappropriate to attempt to evaluate a condition such as evidence of dissolutioning (60.122(c) (10)) without considering, as well, the potential for changes in hydrologic conditions resulting from reasonably foreseeable climatic changes (60.122(c) (6)). The very reason for requiring consideration of potentially adverse conditions is to ensure that the performance objectives will be met and this cannot be accomplished if combined effects are not

10 take~ into account. While the regulation does refer to evai~ating the significance of each of the potentially adverse conc:tions, this was intended to mean that the evaluation must demc~strate how the potentially adverse condition is taken into accc~nt in meeting the performance objectives (i.e., the appl:cation would need to describe the presence of the condition and =onsider that condition in the evaluation of performance).

The ~ule does not and was never intended to exclude the cons:deration of other conditions, whether favorable or pote~tially adverse, that would have a bearing upon performance and ~he sensitivity of such performance to the potentially adve~se condition in question. That is exactly what is called for ~y 10 CFR 60.21(c) (1) (ii) (B), which requires the applicant's Safe~y Analysis Report to include an assessment that, among other thir.;s, analyzes"**. the extent to which it contributes or detracts from isolation." Although we acknowledge that the

- worcing of the existing rule could be read to call for a more corn~artmentalized approach to the analysis of potentially adverse conditions, we view that construction as inappropriate.

The first change that is proposed, therefore, is to remove fro= the technical criteria that portion of the text that deals wit~ methodology, as contrasted with the physical characteristics of ~ie site. Section 60.122 will still include a list of favc~able conditions and potentially adverse conditions. Section 60.~22(a) (1) will continue to require that the geologic setting

11 exhibit an appropriate combination of favorable conditions to provide reasonable assurance that the performance objectives relating to isolation of the waste (clarified by incorporating specific reference to 10 CFR 60.112 and 10 CFR 60.113) will be met. However, the treatment of potentially adverse conditions would be modified. Instead of setting out a methodology for demonstrating that a potentially adverse condition does not compromise the geologic repository's ability to meet the performance objectives relating to isolation of the waste, this portion of the rule would simply declare that the presence of potentially adverse conditions must not so compromise repository performance. Under§ 60.21(c) (1) (ii) (B), the applicant would still be required to carry out the investigations needed to determine whether or not a potentially adverse condition may be present.

Although the means for evaluating the significance of potentially adverse conditions would no longer appear in the technical criteria, they would still be an integral part of the regulation as a whole. This can be demonstrated readily, as follows:

Currently, 10 CFR 60.122(a) (2) requires that the potentially adverse human activity or natural condition be adequately investigated, including the extent to which the condition may be present and still be undetected taking into account

12 the degree of resolution achieved by the investigations.

The proposed rule would accomplish exactly the same thing by amending 10 CFR 60.21(c) (1) (ii) (B), which deals with a site assessment that must be included in the Safety Analysis Report, to specify that "for each potentially adverse condition, the analysis shall demonstrate either its absence or the extent to which its presence may have been underestimated or undetected, taking into account the degree of resolution achieved by the investigations." The phrase "adequately investigated," which was found to be a source of regulatory uncertainty, is to be removed from the regulation. Note that the description of the investigation has been refined to reflect possible underestimation of, as well as nondetection of, potentially adverse conditions.

Currently, 10 CFR 60.122(a) (2) requires that the effect of the potentially adverse human activity or natural condition on the site be adequately evaluated using analyses which are sensitive to the potentially adverse human activity or natural condition and assumptions which are not likely to underestimate its effect. Again, the proposed rule serves the same purpose, by amending the "Content of Application,"

§ 60.2l(c) {l) (ii) (C), to incorporate the same level of detail. The amended language requires evaluations of performance that "shall consider all of the potentially adverse conditions and favorable conditions enumerated in§ 60.122 that have not been determined to be absent," and "in

13 considering any such potentially adverse condition, assumptions should be used that are not likely to underestimate its effects. The phrase "adequately evaluated" is eliminated, but the standard for adequacy of evaluation is made explicit by stating that: "The evaluations must demonstrate that, considering the potentially adverse conditions in combination with other characteristics of the site and design, the performance objectives relating to the isolation of the waste as set out in sections 60.112 and 60.113 of this part will be met.

The proposed rule would differ in two other respects from the existing rule. The new rule clearly indicates that the required evaluations are to be undertaken in combination. This means that the effect of a particular potentially adverse condition would not be studied in isolation but in the context of

- other characteristics of the site and design as well. This is accomplished by requiring the evaluation of the potentially adverse conditions " ... in combination with other characteristics of the site and design. The second difference relates to the elimination of three clauses currently contained in

§ 60.122(a) (2) (iii) that set out alternative ways how the applicant can deal with the presence of potentially adverse conditions - by showing that they are not significant, that they are compensated for by the presence of favorable conditions, or that they can be remedied. What is required is clear:

14 reasonable assurance that the performance objectives relating to isolation of the waste will be satisfied. For the reasons indicated above, the three clauses currently appearing as S 60.122(a)(2)(i)(ii) and (iii) that indicate how the requirement might be satisfied are unnecessary. Thus, even though the alternative ways of dealing with the presence of potentially adverse conditions are not listed, the applicant may continue to employ any of them in demonstrating that the pertinent performance objectives have been satisfied.

Submission of Comments in Electronic Format Commenters are encouraged to submit, in addition to the original paper copy, a copy of the letter in electronic format on a DOS-formatted (IBM compatible) 5.25 or 3.5 inch computer diskette. Text files should be provided WordPerfect format or unformatted ASCII code. The format and version should be identified on the diskette's external label.

Environmental Impact The NRC has determined that this proposed regulation is the type of action described in 10 CFR 51.22(d), pertaining to the promulgation of technical requirements and criteria that the Commission will apply in approving or disapproving applications,

15 under Part 60. Therefore neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.

Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget approval number 3150-0127.

Regulatory Analysis The Commission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

Single copies may be obtained from Mark S. Delligatti, Division of High-Level Waste Management, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Rockville, Maryland 20852, telephone (301) 504-2430.

The Commission requests public comment on the draft

16 regulatory analysis. Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES heading.

Regulatory Flexibility Act Certification As required by the Regulatory Flexibility Act of 1980, 5 u.s.c. 605(b), the Commission certifies that this rule, if adopted, will not have a significant economic impact upon a substantial number of small entities. The only entity subject to regulation under this rule is DOE.

Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule because affected facilities are not licensed under 10 CFR Part 50, and therefore, a backfit analysis is not required. This proposed rule affects only those facilities that will be used for the disposal of high-level waste.

List of Subjects in 10 CFR Part 60 Criminal penalties, High-level waste, Nuclear power plants and reactors, Nuclear materials, Reporting requirements, and Waste treatment and disposal.

17 For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 553, NRC is proposing to adopt the following amendments to 10 CFR Part 60.

PART 60 - DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES

1. The authority citation for Part 60 continues to read as follows:

Authority: Secs. 51, 53, 62, 63, 65, 81, 161, 182, 183, 68 stat. 929, 930, 932, 933, 935, 948, 953, 954, as amended (42 u.s.c. 2071, 2073, 2092, 2093, 2095, 2111, 2201, 2232, 2233);

secs. 202, 206, 88 Stat. 1244, 1246 (42 u.s.c. 5842, 5846); secs. 10 and 14, Pub. L.95-601, 92 Stat. 2951 (U.S.C. 2021a and 5851) ; sec. 102, Pub. L.91-190, 83 Stat. 853 (42 u.s.c. 4332); secs. 114, 121, Pub. L.97-425, 96 Stat. 2213g, 2228, as amended ( 42 u.s.c.

10134, 10141).

2. Section 60.21 is amended by revising paragraphs (c) (1) (ii) (A), (B), and {C) to read as follows:

§ 60.21 Content of application.

18 (c) ***

{l) ***

(ii) The assessment shall contain:

(A) An analysis of the geology, geophysics, hydrogeology, geochemistry, climatology, and meteorology of the site.

(B) Analyses to determine the degree to which each favorable condition and potentially adverse condition enumerated in§ 60.122 has been characterized and has been found to be present. For each potentially adverse condition, the analysis shall demonstrate either its absence or the extent to which its presence may have been underestimated or undetected, taking into account the degree of resolution achieved by the investigations. For these purposes, investigations shall extend from the surface to a depth sufficient to determine critical pathways for radionuclide migration from the underground facility to the accessible environment. Potentially adverse conditions shall be investigated outside of the controlled area if they may affect isolation within the controlled area.

{C) An evaluation of the performance of the proposed

19 geologic repository for the period after permanent closure, assuming anticipated processes and events, giving the rates and quantities of releases to the accessible environment as a function of time; and a similar evaluation that also assumes the occurrence of unanticipated processes and events. The evaluations shall consider all of the potentially adverse conditions and favorable conditions enumerated in§ 60.122 except those that have been determined to be absent. In considering any such potentially adverse condition, assumptions should be used that are not likely to underestimate its effects. The evaluations must demonstrate that, considering the potentially adverse conditions in combination with other characteristics of the site and design, the performance objectives relating to the isolation of the waste, as set out in§§ 60.112 and 60.113, will be met.

3. Section 60.122 is amended by revising paragraph (a) to read as follows:

§ 60.122 Siting Criteria (a) (1) A geologic setting shall exhibit an appropriate

20 combination of the conditions specified in paragraph (b) of this section so that, together with the engineered barrier system, the favorable conditions present are sufficient to provide reasonable assurance that the performance objectives relating to isolation of the waste, as set out in§§ 60.112 and 60.113, will be met.

(2) The presence of potentially adverse conditions must not compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste.

Dated in Rockville, Maryland, this ~d.day of _J_u_ly______ ,

1993.

For the Nuclear Regulatory Commission.

Secretary of the Commission.