ML20135C822

Forwards Final Rule That Will Amend 10CFR60,regulation Governing Disposal of high-level Radwaste in Geologic Repositories

ML20135C822
Person / Time
Issue date:	11/27/1996
From:	Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA)
To:	Gingrich N, Gore A, Murphy R GENERAL ACCOUNTING OFFICE, HOUSE OF REP., SENATE
References
FRN-61FR64257, RULE-PR-60 NUDOCS 9612090108
Download: ML20135C822 (120)

Text

November 27, 1996

.. The o p dent fte n ted States Senate Washington, DC 20510

Dear Mr. President:

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission is submitting a final rule that will amend 10 CFR Part 60, its regulation governing the disposal of high-level radioactive waste in geologic repositories. The final rule will clarify the preclosure performance requirements for considering

, " design basis events" to meet standards for protection against radiation. The final rule will redefine the term "important to safety" to retain the quantitative features _of the existing definition but specifies different numerical criteria for each of two categories of design basis events. Part 60 will further be amended to include requirements for a "preclosure controlled area" and preclosure controlled area boundary reference doses similar to regulatory requirements contained in 10 CFR Part 72, " Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste." These amendments are necessary to provide clarity and consisteacy in the Commission's regulations and, thereby, ensure the adequacy of these requirements to protect public health and safety.

The final rule will resolve issues raised by the U.S. Department of Energy in rulemaking petition PRM-60-3. The petition has merit in particular respects, l and the Commission has incorporated several of the petitioner's suggestions in '

the final rule.

We have determined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.

Enclosed is a copy of the final rule, which is being transmitted to the Federal Reaister for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit '7 determinations. This final rule is scheduled to become effective 30 days after publication in the Federal Reaister.

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Sincerely, g Original signed by/

>" g20ggos M Dennis K. Rathbun, Director PDR Office of Congressional Affairs O

Enclosures:

Final Rule fg Regulatory Analysis ILJ i

kg DISTRIBUTION: (*w/ enc) ci -

DWM r/f NMSS r/f ENGB r/f PUBLIC

! h, ~;Dir Central r/f File

• DMorrison/RES WReamer/0GC OCA r/f RWeller DDancer 14.3 DOCUMENT NAME: A:\CONGRLTS.DBE (rept1trs) *See prev concurrence

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9 NAME MBell /eb/8"f"*d CPaperiello DRathbun b'N ab DATE 11/15/96 11/18/96 11/27/96 b-Lh- \ PT M 0FFICIAL RECORD COPY jg _

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• ' .. The Honorable Al Gore President of the Unit:d States Senate ,

Tha Capitol November 37,1996 Washington, DC 20510

/

Dear Mr. 1 % President:

/

Pursuant to Subtitle E of the Small Business Regulatory E /nforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission is submitting a final rule that will amend 10 CFR Part 60, its regulat' ion governing the disposal of high-level radioactive waste in geologic / repositories. The final rule will clarify the preclosure performance requirements for considering

" design basis events" to meet standards for protection against radiation. The final rule will redefine the term "important to safety" to retain the quantitative features of the existing definition b'ut specifies different numerical criteria for each of two categories of, design basis events. Part 60 will further be amended to include requirements ,for a "preclosure controlled area" and preclosure controlled area boundary reference doses similar to regulatory requirements contained in 10 CFR Part 72, " Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste." These amendments are necessary to provide clarity and consistency in the Commission's regulations and, thereby, ensure the adequacy of these requirements to protect public health and safety.

l The final rule will resolve issues raised by the U.S. Department of Energy in rulemaking petition PRM-60-3. The petitio'n has merit in particular respects, and the Commission has incorporated sever /a1 of the petitioner's suggestions in the final rule. /

Wehavedeterminedthatthisruleisno[a"majorrule"asdefinedin 5 U.S.C. 804(2). We have confirmed thj's determination with the Office of Management and Budget.

/

Enclosed is a copy of the final rule,/which is being transmitted to the Federal ReaistRE for publication. The Regulatory Flexibility Certification is included in the final rule. Also en' closed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cod-benefit determinations. This final rule is scheduled to become effective 30 days after publication in the Federal Reaister.

/

Sincerely, original signed by/

Dennis K. Rathbun, Director

/ Office of Congressional Affairs 7

Enclosures:

Final Rule /

Regulatory Arialysis

/

DISTRIBUTION: (*w/ enc).

Central File

• DWM r/f NMSS r/f ENGB r/f PUBLIC Dir r/f DMorrison/RES WReamer/0GC OCA r/f RWeller DDancer DOCUMENT NAME: A:\CONGRLTS.DBE OFC ENGS,$ NMS[/ OC.A ,

NAME MBeb/Pdem! cpa riello D hlun DATE ////h96 )( / $/96 // /t >/96 ,

OFFICIAL RECORD COPY

The H:ntrable Newt Gingrich Fbvember 27, 1996 Speaker, Unit:d States House of Representatives Th3 Capitol i Washington, DC 20515 l

Dear Mr. Speaker:

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission is submitting a final rule that will amend 10 CFR Part 60, its regulation governing the disposal of high-level radioactive waste in geologic repositories. The final rule will clarify the preclosure performance requirements for considering )

" design basis events" to meet standards for protection against radiation. The final rule will redefine the term "important to safety" to retain the quantitative features of the existing definition but specifies different .

numerical criteria for each of two categories of design basis events. Part 60  !

will further be amended to include requirements for a "preclosure controlled l area" and preclosure controlled area boundary reference doses similar to i regulatory requirements contained in 10 CFR Part 72, " Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste." These amendments are necessary to provide clarity and consistency in 1 the Commission's regulations and, thereby, ensure the adequacy of these i requirements to protect public health and safety.

The final rule will resolve issues raised by the U.S. Department of Energy in rulemaking petition PRM-60-3. The petition has merit in particular respects, and the Commission has incorporated several of the petitioner's suggestions in the final rule.

We have determined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.

Enclosed is a copy of the final rule, which is being transmitted to the Federal Reaister for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations. This final rule is scheduled to become effective 30 days after publication in the Federal Reaister.

Sincerely, original signed by/

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

Final Rule Regulatory Analysis DISTRIBUTION: (*w/ enc)

Central File

• DWM r/f NMSS r/f ENGB r/f PUBLIC Dir r/f DMorrison/RES WReamer/0GC OCA r/f RWeller DDancer DOCUMENT NAME: A:\CONGRLTS.DBE OFC E@B,, Ut4S[) OC_A NAME MBbM/Prf red C e iello D un DATE 1/ //N96 lI/ b96 // A 7/96 0FFICIAL RECORD COPY

Mr. Robert P. Murphy General Counsel November 27, 1996 Gen:ral Acccunting Office Room 7175 441 G Street, NW Washington, DC 20548

Dear Mr. Murphy:

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission is submitting a final rule that will amend 10 CFR Part 60, its regulation governing the disposal of high-level radioactive waste in geologic repositories. The final i rule will clarify the preclosure performance requirements for considering -

" design basis events" to meet standards for protection against radiation. The final rule will redefine the term "important to safety" to retain the quantitative features of the existing definition but specifies different 4

numerical criteria for each of two categories of design basis events. Part 60 4 will further be amended to include requirements for a "preclosure controlled

! area" and preclosure controlled area boundary reference doses similar to regulatory requirements contained in 10 CFR Part 72, " Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste." These amendments are necessary to provide clarity and consistency in the Commission's regulations and, thereby, ensure the adequacy of these requirements to protect public health and safety.

1 The final rule will resolve issues raised by the U.S. Department of Energy in a rulemaking petition PRM-60-3. The petition has merit in particular respects, and the Commission has incorporated several of the petitioner's suggestions in 4 the final rule.

We have determined that this rule is not a " major rule" as defined in f 5 U.S.C. I54(2). We have confirmed this determination with the Office of Management and Budget.

1 Enclosed is a copy of the final rule, which is being transmitted to the 3 Federal Reaister for publication. The Regulatory Flexibility Certification is  !

included in the final rule. Also enclosed is a copy of the Regulatory Analysis for this final rule that contains the NRC's cost-benefit j

determinations. This final rule is scheduled to become effective 30 days

, aftar publication in the Federal Reaister.

i Sincerely, J Origiml signed by/

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

Final Rule i Regulatory Analysis DISTRIBUTION: (*w/ enc) 4 Central File

• DWM r/f NMSS r/f ENGB r/f PUBLIC Dir r/f DMorrison/RES WReamer/0GC OCA r/f RWeller DDancer i DOCUMENT NAME: A:\CONGRLTS.DBE

OFC m ENGBo NMES/) OGAo 4 NAME MN1hb/P d "*'

Ch iello kathbun DATE // /j([95 N/[/96 4/l?/96 0FFICIAL RECORD COPY

0 0

i FINAL RULE ;

I i

I 1

[7590-01-P]

NUCLEAR REGULATORY COMMISSION 10 CFR Part 60 RIN: 3150-AD51 Disposal of High-Level Radioactive Wastes I l

in Geologic Repositories; Design Basis Events AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule, j l

l

SUMMARY

The Nuclear Regulatory Commission is amending its l 1

regulations on the protection of public health and safety from l activities conducted at a geologic repository operations area i I

(GROA) before permanent closure. In particular, the final rule j addresses the measures that are required to provide defense in l l

depth against the consequences of " design basis events." These measures include prescribed design requirements, quality assurance requirements, and the establishment of a preclosure controlled area from which members of the public can be excluded.

EFFECTIVE DATE: , 1996 (30 days from date of publication in the Federal Register).

FOR FURTHER INFORMATION, CONTACT: Dr. Richard A. Weller, Division of Waste Management, Office of Nuclear Material Safety

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i I and Safeguards, U.S. Nuclear Regulatory Commission, Washington,  !

DC 20555, telephone (301) 415-7287. l f

SUPPLEMENTARY INFORMATION: [

?

I

Background

i Under the Nuclear Waste Policy Act of 19:32, as amended, the  !

U.S. 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 j radioactive waste. The Commission's regulations pertaining to  !

these geologic repositories appear at 10 CFR Part 60. In recent years, NRC, in conjunction with its Federally-Funded Research and j Development Center, the Center for Nuclear Waste Regulatory i Analyses, completed a comprehensive review of the requirements of l 1

Part 60 regarding their clarity and sufficiency to protect public i l

l health and safety. NRC focused particular attention on any 3

matters that may be ambiguous, insufficient for their intended purpose, or inconsistent with other expressions of its regulatory policy. Independently, DOE conducted a similar review of Part 60.

The NRC review identified deficiencies regarding the clarity and sufficiency of the current Part 60 requirements to protect 2

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j public health and safety for the full range of credible 4

conditions or events that may occur at an operating repository, including those low-probability events that have potentially serious consequences. NRC also noted that certain elements of

existing Part 60 differ from counterpart requirements in other NRC rules where greater consistency in language would be I beneficial. DOE's independent review of Part 60 requirements identified similar deficiencies in these requirements. To address these issues, DOE filed a petition for rulemaking (PRM), j i

PRM-60-3, on April 19, 1990.

In responne to the DOE petition and the results of.the NRC  !

review of Part 60, the Commission published a proposed rule for  !

public comment in the Federal Register on March 22, 1995 l

(60 FR 15180) to clarify the requirements for protection of public health and safety related to activities conducted at a GROA before its permanent closure. In particular, the proposed  !

rule provided new and modified definitions for certain terms (including the definition of "important to safety," with j reference to structures, systems, and components) , dose criteria for accident conditions, and requirements for the establishment of a preclosure controlled area from which members of the public can be excluded when necessary. In an accompanying notice l i

(March 22, 1995; 60 FR 15190) the Commission also granted in  ;

part, and denied in part, the specific proposals in the DOE petition. For a fuller discussion of the PRM, the proposed rule, 3  !

and the partial grant / partial denial of the DOE petition, see the Federal Register notices cited above. As noted in the Federal Register notice for the proposed rule (60 FR 15180) and as intended in subsequent discussions in this notice, unless the specific context suggests otherwise, the terms " provisions,"

" requirements," " standards," and " criteria" are generally used interchangeably; the term " limit" (as in " dose limit") is generally used to refer to a specific type of requirement or criterion; and the term " rule" is generally used to refer to the entire set of requirements or criteria (e.g., Part 60). This final rule completes NRC action related to PRM-60-3.

Lastly, the Commission notes that, consistent with the mandates of the Energy Policy Act of 1992, the Environmental Protection Agency (EPA) is developing site-specific environmental radiation protection standards for a potential repository at Yucca Mountain, Nevada. In this regard, the Act specifies that, within one year after promulgation of the EPA standards, the Commission must promulgate a rule so that Commission regulations are consistent with the new EPA standards. Although the primary focus of the new EPA standards is on the postclosure period of repository performance, the staff will ensure that the current modifications to Part 60 proposed herein, which focus on the period of repository operations before permanent closure, are consistent with the new EPA standards. To the extent any inconsistencies between NRC and EPA requirements are identified, 4

they will be addressed in the planned future rulemaking by NRC to address new EPA standards.

[

Public Comments on the Proposed Rule A period of 90 days was specified in the Federal Register for public comments on the proposed rule. The Commission specifically sought public comments on: (1) the appropriateness of the proposed 0.05 SV (5 rem) dose limit in new 10 CFR 60.136 as the repository design basis for protection of public health and safety during accident conditions, and (2) the rationale supporting the proposed 0.05 Sv (5 rem) dose limit. Ten sets of comments were received on the proposed rule from the following organizations and individuals: (1) The Clean Water Fund of North Carolina (CWFNC) ; (2) Mr. Vernon J. Brechin; (3) DOE, Office of Civilian Radioactive Waste Management; (4) EPA, Office of Federal Activities; (5) Nye County, Nevada, Nuclear Waste Repository Project Office; (6) Virginia Power Company; (7) Nuclear Energy (

Institute (NEI); (8) Environmental Coalition on Nuclear Power (ECNP); (9) Wisconsin Electric Power Company; and (10) Mr. Marvin I. Lewis.

The principal issues raised in the comments are summarized )

below. (Comments that are duplicative, editorial, or beyond the scope of the rulemaking are not discussed herein but have been considered in the analysis of the public comments.) For the 5

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reasons indicated, the Commission has decided to adopt the amendments substantially in the form proposed in the March 22, 1995, Federal Register notice (60 FR 15180) but with the changes noted that reflect the Commission's analysis of the public comments.

1. Controlled Area - Waste Isolation.

DOE noted that the supplementary information in the proposed rule referred to the " controlled area" as one "... (within which waste isolation is to be ensured after permanent closure)," DOE observed that this is inconsistent with the Part 60 definition of

" controlled area," which does not refer to waste isolation. DOE recommended that the Commission delete the parenthetical phrase in the supplementary information.

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The Commission agrees that the parenthetical phrase does not properly characterize the definition of " controlled area."

However, rather than deleting the parenthetical phrase altogether, the Commission has modified the phrase to accurately reflect the definition of " controlled area" and its focus on postclosure activities.

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2. Multiole Failure Scenarios.

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DOE noted that the supplementary information under $60,136

seemed to indicate that multiple independent failure scenarios 4

would be considered to be Category 2 design basis events and observed that, typically, nuclear safety analyses are not required to assume multiple failures of safety-related systems unless they are all credible consequences of the initiating 2

event. DOE recommended that the Commission clarify how it intends to review the acceptability of repository systems, structures, and components in the context of the new rule.

The Commission agrees with this comment and has revised the supplementary information to clarify how it intends to review the analysis in the DOE license application to demonstrate compliance with the requirements of S60.136. ,

3. Probability Bounds for Desian Basis Events.

In the Section-by-Section Analysis of $60,136 in the proposed rule, the Commission indicated that the lower bound for category 2 design basis events is on the order of 1 x 10 4 per year (i.e., events with probab'slities of occurrence less than 1 x 10" per year would generally be screened from further ,

1 consideration due to their negligible contribution to overall  !

risk). DOE and NEI objected that this lower bound is much too low and unjustified. DOE recommended a lower bound of 1 x 10-

' per year and NEI recommended a lower bound in the range of 7

i

3 1 x 10~' per year to 1 x 10" per year. On the other hand, ECNP recommended that the most improbable sequences and combinations of events and accidents (Category 2 and beyond) should be evaluated in repository accident analysis.

The Commission agrees with DOE and NEI that the lower probability bound discussed in the proposed rule for Category 2 design basis events is too low and is unjustified. The Commission considers that, on the basis of repository risk perspective, a lower probability bound of 1 x 10-' per year is appropriate for these events. The Commission recognizes that the estimated consequences from Category 2 design basis events are somewhat limited and would not likely exceed several tenths of Sv

- (several tens of rem). At this consequence level, the estimated risk of cancer fatality from events with a probability lower than 1 x 10-' per year is less than 1 x 10-s per year. To put this risk in perspective, the International Commission on Radiological Protection 1 notes that a fatal cancer risk in the range of 1 x 10~' to 1 x 10-5 per year from exposure to radiation would likely be acceptable to members of the public. As such, Category 2 design basis events which result in fatal canc9r risks on the order of 1 x 10-s per year or lower do not contribute significantly to individual risk. Accordingly, events with

' Recommendations of the International Comission on Radiological Protection. ICRP Publication 26, January 1977.

8

probabilities of occitrrence lower than 1 x 10-' per year can be screened from further consideration in repository risk analysis.

The Commission has revised the section-by-Section Analysis of $60.136 to reflect a lower bound for Category 2 draign basis j events on the order of 1x10-' per year.

4. Definition of "Imoortant to Safety" - Enaineered Features.

DOE noted that the phrase " engineered structures, systems, and components," currently in the definition of "important to safety," was removed from the new definition and observed that it is clearly the intent of the regulation to apply the definition to engineered systems, not natural systems.

The Commission agrees with this comment and has revised the definition of "important to safety" to clarify this intent.

5. Anolicability of Environmental Protection Acency Standards to the Manaaement and Storace of Hiah-Level Waste.

l DOE stated that the proposed rule did not address all of the regulatory uncertainty associated with dose limits for design basis events because both the existing rule and the proposed rule 9

1

J appear to require compliance with both EPA radiation protection standards and Part 20 radiation standards and there is'an  ;

inconsistency between these two standards. Virginia Power noted that the definition of "important to safety" establishes the Part 20 limits that are referenced in 10 CFR 60.111(a) as the acceptance criteria for the category 1 design basis events and l l

concluded that this seems to be inappropriate. Virginia Power j 1

stated that Part 20 establishes occupational dose limits and I I

radiation dose limits for members of the public, that these limits are expressed as annual limits, and that these limits are associated with normal licensed activities - not design basis ,

events. Virginia Power considered that it is not appropriate to l

use Part 20 limits to evaluate specific events. Virginia Power further considered that acceptance criteria for design basis events are associated with the specific consequences of those l l

events, as for example in 560.136 for the Category 2 design basis events, and that appropriate acceptance criteria will need to be l l

developed if category 1 design basis events are retained by the ]

final rule. ,

I The commission agrees with DOE that both the dose limits and l the methodology for calculating doses to members of the public in l l

the EPA standards differ from the dose limits and methodology for calculating doses to members of the public in Part 20, Subpart D. ,

1 Notwithstanding the differences between these standards, the j staff does not consider that there is any regulatory uncertainty 10

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, regarding applicable dose limits for category 1 design basis events. In DOE's demonstration of compliance, either the EPA standards or the Part 20 standards may be more limiting or controlling than the other, but that does not relieve DOE of the requirement to comply with both standards. As such, the Commission has made no changes to the proposed rule to address 4

DOE's concerns about the differences between Part 20 and the EPA j standards.

j The Commission disagrees with Virginia Power that Part 20 limits are inappropriate. The Commission's numerical radiation protection standards are codified in Part 20 and apply to i

) operations at a geologic repository by virtue of 10 CFR 20.1002 4

and $60.111 (a) . However, it is not the Commission's intent that it is necessary to use the annual limits in Part 20 to evaluate specific Category 1 design basis events on an individual basis.

Instead the Commission intends that the gum of the annual doses, exposures, and releases from all Category 1 design basis events .

- shall not exceed the limits specified in Part 20 and in the EPA l

, standards. I i

6. Preclosure Controlled Area.

DOE expressed a concern that the use of the word "immediately" in the definition of "preclosure controlled area" could lead to an implication that the boundary must be next to 11

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the GROA. DOE also expressed a concern that the use of the word j " nearest" in $60.136(b) (i.e., " ...no individual located on or beyond the Esapsjt boundary of the preclosure controlled  ;

. area...") is confusing.

1 4 The Commission agrees with these comments and has:

j (1) deleted the word "immediately" in the definition of )

"preclosure controlled aren" in 10 CFR 60.2, (2) changed the 3

phrase " nearest boundary" to "any point on the boundary" in the ,

i definition of "important to safety" in S60.2 and in the design requirements of the geological repository operations area in a

S60.136(b).

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) 7. Definition of Site.

DOE recommended that the definition of " site" should include "preclosure" and "postclosure controlled areas."

i The commission agrees with this comment and has modified the I

definition of " site" to reflect its meaning during the period before permanent repository closure (i.e., the operational period), as well as the period following permanent closure.

8. Effluent Control.

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I DOE stated that, with the deletion of the term "during normal operations," the application of the Part 20 effluent j limits invoked by $60.111(a) is not clear. DOE recommended that 10 CFR 60.132 (c) (1) be revised to clarify that the latter section i is applicable only to Category 1 design basis events.

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The commission agrees with this comment and has revised.

560.132 (c) (1) to clarify that this section is applicable only to Category 1 design basis events.

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9. Criticality Control.

DOE noted that the Commission intended to clarify the  !

i requirements pertaining to criticality control, currently in l 10 CFR 60.131(b) (7) , but that some confusion concerning those i requirements remains. DOE pointed out that the proposed l criticality. control requirements in 560.131(h) refer to

" isolation of radioactive waste," a phrase with postclosure connotations, while noting that systems "must be designed for .

criticality safety assuming occurrence of design basis events," a i

phrase which has preclosure implications. Furthermore, DOE argued that the last sentence in 560.131(h) could be interpreted l as requiring a deterministic demonstration of criticality safety over the entire period of regulatory concern. However, given the 4 time frames involved, DOE considered probabilistic analyses to be i an essential part of demonstrating long-term criticality safety. l 13 l l

J i The Commission considers that the applicability of the criticality control requirements proposed in S60.131(h) is clear with respect to preclosure considerations but agrees with DOE that uncertainty remains with respect to the applicability of the

, criticality control requirements to the postclosure period.

1 However, the commission intends to address this remaining uncertainty in a future rulemaking to make the NRC requirements consistent with the revised EPA standards that are currently under development, as mandated by the Energy Policy Act of 1992.

Accordingly, in this final rule, S60.131(h) is promulgated, as proposed in the proposed rule.

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10. The Use of the terms "Imoortant to Safety."

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" Accidents." " Normal Conditions," " Anticipated Operational Occurrences " and "Desian Basis Events" in Part 60.

CWFNC stated that there was not any ambiguity in the current use of the terms "important to safety" and " accidents" in Part 60. ECNP stated that the terms " normal conditions,"

" anticipated operational occurrences," and " accidents" are not equivalent to nor adrsquately described by the term " design basis events."

The Commission disagrees with CWFNC that there is no ambiguity in the current use of the terms "important to safety" 14

l or " accidents" in Part 60. The latter term is undefined in Part 60, and there is uncertainty about its meaning with respect to the range of events the term encompasses. The full range of Category 1 design basis events would not generally be considered as " accidents," especially those events occurring regularly or moderately frequently. However, certain lower frequency Category 1 events, which occur one or more times during the operating lifetime of a facility and are otherwise known as

" anticipated operational occurrences," have at times been identified as " accidents." But " anticipated operational occurrences" are conditions of normal operation which are not to be confused with the unlikely, but credible and potentially significant, Category 2 design basis events. As such, the current definition of "important to safety" is unclear with respect to its intended applicability to the design of structures, systems, or components for normal operations, including anticipated operational occurrences. Further, with the focus on protection of members of the public in unrestricted areas, the current definition of "important to safety" does not explicitly address protection for the occupational work force.

The uncertainty is not related to interpreting the meaning of

" unrestricted area" but, rather, is related to the narrow focus of public exposure in unrestricted areas. Lastly, the value of 0.005 Sv (0.5 rem) as a dose limit in unrestricted areas for

" accident" conditions lacks consistency with a corresponding limit in Part 72 and with dose values established as guidance for 15

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! selected accidents (fuel handling and cask drop events) at  ;

l l Part 50 facilities (commercial power reactors).  ;

i Notwithstanding the comments offered by ECNP, the commission considers that the definition of " design basis events" in the j proposed rule does adequately define that term and that the l l .

supplementary information in the proposed rule does adequately I l describe the relationship between the terms " normal conditions," l l " anticipated operational occurrences," " accidents," and " design basis events." In this regard, it was the Commission's intent to supplant undefined terms in the rule (i.e., " normal conditions,"  !

" anticipated operational occurrences," and " accidents") with a j defined term (i.e., " design basis events").

For the above reasons, the Commission has not revised the definitions in the proposed rule for " design basis events." As l discussed in items 4 and 6 above, editorial changes have been made to the definition of "important to safety," but these  !

changes are unrelated to the arguments advanced by CWFNC or ECNP. }

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11. Radiation Protection Standardg.

L CWFNC stated that a 0.005 Sv (0.5 rem) limit would not be  !

overly protective of public health and safety and there is no reason to seek a weaker standard. CWFNC suggested modifying  !

i  ;

i Part 20 to clarify any ambiguities in radiation protection  !

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standards for repositories. ECNP offered a number of comments  !

related to_ radiation protection standards:

• The Commission should require DOE to provide design basis accident analyses for more than undefined " critical design basis events, singly" and should require demonstration that  !

l doses would be kept far below the maximum permissible dose {

limits, with an as low as is reasonably achievable requirement at least comparable with that for operating reactors.

• The Part 60 limits must be much more stringent than for operating nuclear facilities.  ;

e The limit of radiation exposure should be no higher than the l most restrictive exposure limit that EPA imposes for any i

licensee or other source of regulated nuclear activity.

• A 0.005 Sv (0.5 rem) limit should be impermissible for an -i individual dose from a waste site.  ;

e The most stringent level of worker protection, better than l; Part 20, should be required.

{

e Part 20 standards are not restrictive enough for the purpose '

of public health protection with respect to the storage and i

disposal of radioactive waste. l e The definitional alteration of the term "important to j i

safety" is not adequate to assure health protection for the public because the proposed categories 1 and 2 numerical  ;

limits for radiation exposures are based on standards that  !

l have failed to take into account the noncancer but adverse l l.

17 I i

I

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

i I health' effects of chronic low-dose radiation exposures that l have been reported in the literature since development of l NRC's Part 20 revision, e Extremely conservative radiation protection standards should i

be utilized in repository design and performance criteria,  !

i f and a zero release facility design goal should be required i for all radioactive waste management. ,

? e An acceptable rationale for the 0.05 Sv (5 rem) dose limit l proposed in the proposed rule is totally absent.

i The Commission acknowledges that the 0.005 Sv (0.5 rem) dose  !

limit in the definition of "important to safety" in the existing j i

rule could be construed to be an implicit basis for designing l structures, systems, and components to prevent or mitigate the  !

r consequences of accidents at the boundary of the unrestricted area. On the other hand, the 0.005 Sv (0.5 rem) dose limit could l i

also be interpreted more narrowly, to identify only those j structures, systems, and components that are subject to  !

additional design requirements and a quality assurance program to ensure performance of intended functions. See 560.131(b) and i I

S60.151. In short, the 0.005 Sv (0.5 rem) dose limit in the definition of "important to safety" in the existing rule is, in the Commission's view, subject to conflicting interpretations. ,

As previously discussed, the Commission's comprehensive review of j I

Part 60 identified deficiencies in both the clarity and 18 i

sufficiency of requirements to protect workers and public health and safety. Among the identified deficiencies is the regulatory uncertainty created by possible conflicting interpretations that could be given to the 0.005 Sv (0.5 rem) dose limit in the -

"important to safety" definition described above and by the l absence of an explicit design basis dose limit in Subpart E of 4

the existing rule. An objective of this rulemaking is, therefore, to resolve the uncertainty in Part 60, as well as remedy the incomplete definition of "important to safety" that fails to address protection of both workers and members of the 4

public during category 1 design basis events (i.e., " normal conditions," including " anticipated operational occurrences"). ,

j The Commission has addressed these deficiencies with the addition of new $60.136, which now provides explicit design basis accident

]

l dose criteria for repository structures, systems, and components, and modification of the definition of "important to safety" to ,

include the broader interests of both worker and public health l

and safety for the full range of conditions or events that may occur before repository closure. The commission believes that a

these amendments, as well as the others as described herein, clarify and enhance the provisions in the rule to protect worker and public health and safety.

l 1 l It was not the intent of this rulemaking to modify, in any way,  !

the Commission's numerical radiation protection standards. As l

. I discussed earlier, these standards are codified in Part 20 and 19

i apply to operations at a geologic repository by virtue of

$20.1002, as well as $60.111(a). The Commission believes that these standards continue to be appropriate for its licensees and provide adequate protection of worker and public health and I safety at a repository. As such, comments by CWFNC and ECNP I about possible modifications to the Commission's radiation i protection standards as they would apply to an operating repository are beyond the scope of this rulemaking.

) '

The Commission agrees with ECNP that the term " critical design 3

basis events" is undefined and, in the Section-by-section Analysis of $60.21 of this final rule, has changed " critical 4

design basis events" to " Category 2 design basis events." With regard to the scope of design basis accidents that should be considered in the license application, the Commission previously addressed this issue in the discussion of probability bounds for Category 2 design basis events and determined that events with probabilities of occurrence lower than 1 x 10 per year could be screened from further consideration due to their negligible contribution to individual risk.

Regarding the rationale for the 0.05 SV (5 rem) dose limit in 560.136, the Commission continues to believe that the potential risks to members of tne public from an operating repository are very small. In light of this limited risk, the 0.05 Sv (5 rem) dose limit provides an adequate margin of safety and an 20 l

e 1

l appropriate basis for the design of repository structures, systems, and components to prevent or mitigate the consequences i

( of low probability, but credible events. The Commission's reasoning behind the 0.05 Sv (5 rem) dose limit can be found in the Caction-by-Section Analysis of $60.136 that appears later in this notice.

l l

12. Exclusion of the Public from Preclosure Controlled  ;

Area.

Vernon J. Brechin objected to the use of the word "can" versus "will" in the description of preclosure controlled area.  ;

The Commission disagrees with this comment. It is not the ,

Commission's intention to generally exclude members of the public l from the preclosure controlled area (which would be the i

" controlled area" as defined in 10 CFR 20.1003). However, access to the preclosure controlled area can be limited by the licensee for any reason (not necessarily one related to radiation protection). Within the preclosure controlled area will be a  !

" restricted area" (as defined in 560.2 and $20.1003). Access to a restricted area must be controlled for purposes of radiation 1

protection. Members of the public in the preclosure controlled area will be subject to the dose limits for members of the public 21 ,

I I

i i

i 4

in 10 CFR 20.1301. However, an individual who' receives  ;

j occupational dose in the preclosure controlled area will be l 1 subject to the occupational dose limits of Part 20, f,ubpart C.-

i ,

i All doses in a restricted area are occupational doses. The size  ;

i of the preclosure controlled area is not specified by the regulations because it will be dependent upon the particular I I

I activities conducted during the operational period.

l-' ,

i 13. Definition of Desian Basis Events.

i  :

Virginia Power and NEI recommended that the definition of

, i j " design basis events" should make clear that the normal ,

operations associated with receiving, handling, packaging,  ;

i l

! storing, emplacing, and retrieving high-level waste are not t

l design basis events.

i' The Commission disagrees with this comment. It is the Commission's intent that events occurring regularly or frequently

during the course of normal operations arg considered as Category 1 design basis events. Category 1 design basis events effectively embody repository activities and conditions j previously identified in Part 60 as " normal operations, including l anticipated operational occurrences." In this regard, the Commission intends the Part 20 dose limits to be applicable to the conduct of repository activitios, such as receiving, i

3, 22 -

1 1

handling, packaging, storing, placing, and retrieving high-level

! waste.

i

14. Definition of "Important to Safety" -

Function.

i l Virginia Power noted that in the proposed rule, the 3 definition of "important to safety" refers to ". . . (1) to provide i

reasonable assurance that high-level waste can be received,

handled, packaged, stored, emplaced, and retrieved without exceeding the requirements of [10 CFR) 60.111(a) for Category 1

, design basis events; or...." Virginia Power recommended that this part of the definition should be revised to make it clear

. that the focus of important to safety is design basis events and DQ1 the normal opere.tions that are described by the definition in the proposed rule.

The Commission disagrees with this comment. As explained in 4

. Item 13, the Commission intends that evento occurring regularly or frequently during the course of normal operations are l considered as Category 1 design basis events.

l

15. Definition of "Imoortant to Safety" - Ouality Assura11ce Issues.

Virginia Power and NEI stated that the definition of "important to safety" proposed in the proposed rule would apply 23

b

\

+

j '

t I

i full Quality Assurance (QA) requirements to almost every system

< r

] and component of the repository, and that the latter definition l I does not establish a graded QA system to properly distinguish ,

4  !

systems that are "important to safety" and ensure that the full  !

j QA program is only applied to those systems. [

i i i  !;

j The Commission disagrees with this comment. When [

1  !

j identifying items "important to safety," if it is determined that  !

i  !

j a particular structure, system, or component is essential to maintaining doses below Part 20 limits during normal operations  ;

i j (or during any Category 1 design basis event), then that

?-

I structure, system, or component must be designated as "important ,

t i l to safety." The list of structures, systems, and components  ;

I "important to safety," as well as the list of engineered barriers l i

l "important to waste isolation," are collectively referred to as l i

j the "Q-list" and are subject to the QA provisions of Part 60, f i i l Subpart G. The Commission supports a graded approach to meeting l 1  !

l the QA provisions of Part 60. Such an approach is consistent l 1

l with the NRC staff's " Technical Position on Items and Activities l

! I l in the High-Level Waste Geologic Repository Program Subject to QA ,

i ,

l Requirements (NUREG-1318)." The guidance given in that technical  !

i

! position (TP) is still applicable under the rule's changes. The  !

i TP describes a graded application of QA measures consistent with  !

l j that applied to other facilities (e.g., nuclear power reactors) l t

licensed by the Commission. In this regard, the application of f

{

! QA program requirements to repository structures, systems, and 2 24 i 4 _

i l 1

4

- - , , - . , - . - . - . . . - - -.- . ~ - - < . . , - - - - .. .-. ---~rv . -

4 l

components would generally be commensurate with their importance to safety.

16. Desian Bases - Similarities between GROA Facility and

,other Facilities Licensed by NRC.

ECNP stated that it is wrong to liken design basis for a waste repository (or long-term storage) facility to design basis for an operating nuclear reactor or other contemporary nuclear facility because of the longevity of the hazard and uncertainties of future monitoring and control.

The Commission disagrees with this comment. The design bases provided in the rule are for operations at-the GROA and not for postclosure performance. Because operations at the repository are expected to be similar to operations at other facilities licensed by the Commission (e.g., 10 CFR Part 72 l l

facilities), the Commission believes that it is appropriate that their design bases be comparable.  ;

1 l

17. The Phrase "At All Times".

l l

ECNP recommended that~the phrase "at all times" should be retained throughout Part 60.

l l

25 l

l 1

The Commission disagrees with this comment. The phrase "at all times" was originally included in the regulation to emphasize ,

the need to design the GROA such that retrieval activities, if found necessary, would be conducted in accordance with Part 20.

• The commission continues to interpret the regulation in this f

manner but has removed the phrase "at all times" from $60.111 in E the rule to clarify that the limits of Part 20 apply to

{

category 1 design basis events and that the separate design bases ,

i of $60.116 apply.for Category 2 design basis events. Further, l the Commission recognizes that conformance to the regulations should not hinder any actions that are necessary to protect public health and safety, such as lifesaving or maintaining confinement of radioactive materials (May 21, 1991; 56 FR 23365).  !

The phrase "at all times" is ambiguous in this respect and was l therefore removed.- f i

18. AS HIGH AS REASONABLY ACHIEVABLE (AHARA) Desian Standard for the GROA.  ?

ECNP recommended that NRC adopt an AHARA standard with respect to criteria for the design of the GROA. ECNP states that the purpose of such a standard would be to provide an extra measure of conservatism in the design. ECNP further states that, for an operating nuclear facility, regulatory changes over time that mandate tighter standards and. reduced emissionn can be 26

• i accommodated by means of backfitting, but this is not so readily l l accomplished at a disposal facility. l l

's l The Commission disagrees with this comment and considers i i

l that the requirements of Part 60, as amended in this rulemaking,  !

are sufficient to ensure public health and safety. The f

Commission also considers that backfitting, if necessary, can be  !

j accomplished at a disposal facility.  !

l l

Section-by-Section Analysis ,

l 5 Section.60.2. Definitions. l l

l The amendments involve 10 definitions needed in Part 60. f I

l The term "preclosure controlled area" is new. It is essentially the same as the term "preclosure control area" I

proposed by DOE in its petition (PRM-60-3) and corresponds  !

closely to the term " controlled area," as defined in 10 CFR 72.3.

]

The term "preclosure controlled area" is adopted because Part 60 already refers to a " controlled area" (which area has been  !

I committed to use as a geologic repository and from which  ;

l incompatible activities would be restricted following permanent closure). The function of the new term is to delimit an area l i

over which the licensee exercises control of activities to meet I

I regulatory requirements. Control includes the power to exclude i

l

' 27 1

1 1

-- --y--- - , , - . - - -, -. - , - - ,m ,

, ,,m. - . - - , - - - - - , - m- - _ .

. 6 members of the public, if necessary. Because Part 60 (unlike ,

Part 72) involver, ongoing underground operations and timeframes of concern over centuries and millennia, language in the i

definition is included that, consistent with its function, limits i

l the area to the surface and limits the duration to the period up to, and including, permanent closure.

l The existing term " controlled area" is renamed "postclosure ,

controlled area," to avoid any confusion or misunderstanding I about this term in relation to its use in Parts 20 and 72.

However, no substantiva change is intended for the "postclosure controlled area" because this is a change in nomenclature only.

Consistent with this nomenclature change, the term " controlled area" is changed to "postclosure controlled area," where it i 1 appears in the definitions for " accessible environment,"

" disturbed zone," and " site."

i The term "important to safety" is amended to address the J

issues previously discussed. The existing provision is unclear and fails to ensure proper levels of protection of public and worker health and safety for the broad range of conditions or events that might occur at a repository site. This is an I important term because it is the predicate for required design l i

! features as well as required quality assurance measures that l

provide defense-in-depth. The Commission is retaining the

quantitative features of the existing definition but is l l

28 5 l

4 specifying different numerical limits for each of the two categories (1 and 2) of design basis events. The structures, systems, and components "important to safety" are those necessary: (1) to provide reasonable assurance that the requirements of $60.111(a) would be observed for Category 1 design basis events; or (2) to prevent or mitigate Category 2 design basis events that could result in doses equal to, or greater than, the values specified in [new) S60.136 to any individual located en or beyond any point on the boundary of the preclosure controlled area.

Although the term " design bases" appears in existing Part 60, in S60.21(c) (2) , it was not defined. As the previous discussion makes clear, " design bases" should be understood in relation to that range of events, including external natural or man-induced events, that is taken into account in the design, and, in particular, in relation to conditions that could result in radiological consequences beyond specified limits. The definition in Part 72 is inserted, without change, into the list of defined terms in $60.2.

The inclusion of a definition of " design basis events" serves two purposes. First, it identifies a set of events (referred to elsewhere as category 1 design basis events) that must be taken into account in demonstrating compliance with the requirement to show, with reasonable assurance, that the 29

i  ;

+ I F . l l

provisions of Part 20 will be met. (This set of events is j described as "...those natural and human-induced events that are ,

1 i

reasonably likely to occur regularly, moderately frequently, or  ;

i

) one or more times before permanent closure of the geologic )

i i j repository operations area.") Second, it identifies an l

additional set of events (previously referred to as Category 2-design basis events) that must be taken into account in applying the commission's defense-in-depth philosophy. (This set of events is described as those "...other natural and human-induced events that are considered unlikely, but sufficiently credible to warrant consideration, taking into account the potential for significant radiological impacts on public health and safety.")

l The Commission recognizes that the criterion of "sufficiently I

credible to warrant consideration" is inexact, leaving its I

application to a consideration of the particular site and design that are the subjects of a license application. Generally, the Commission would expect that such design basis events would include as broad a range of external phenomena as would be taken into account in defining the design basis for other regulated facilities, including nuclear reactors. The commission would also expect that the analysis of a specific design basis event would require an analysis which includes an initiating event (e.g., an earthquake) and the associated combinations of repository system or component failures that can potentially lead to exposure of the public to radiation.

l 30

o The definitions of " restricted area" and " unrestricted area" are amended to conform with the definitions in Part 20. The current definitions in Part 60 do not precisely conform to the current Part 20 because no change was made to these Part 60 definitions when Part 20 was revised.

The amendments of $60.2 adopted in this final rule differ from the amendments of $60.2 proposed in the proposed rule (March 22, 1995; 60 FR 15180) in the following respects: (1) the revised definitions of " restricted area" and " unrestricted area" were not proposed in the proposed rule; (2) in the definition of "important to safety," the phrases " features of the repository" and " nearest boundary" in the proposed rule were changed to

" engineered features of the repository" and "any point on the boundary," respectively; (3) in the definition of "preclosure controlled area", the phrase "immediately surrounding the geologic repository operations area" in the proposed rule was changed to " surrounding the GROA"; and (4) in the definition of

" site", the phrase " location of the postclosure controlled area" was changed to " location of the preclosure controlled area, or of the postclosure controlled area, or both." The rationale for the revised definitions of " restricted area" and " unrestricted area" is provided in the preceding paragraph. The rationale for the other changes is discussed under " Response to Public Comments on the Proposed Rule."

31

. i V

Section 60.8. Information collection recuirements:

I OMB acoroval.  ;

NRC is updating 10 CFR 60.8, "Information Collection Requirements: OMB Approval," to reflect the fact that subsequent to the original issuance of Part 60, NRC requested, and obtained i i Office of Management and Budget (OMB) approval for the Part 60  ;

"Information Collection Requirements." Section 60.8 was to be corrected the first time other revisions were made.

l The amendment of $60.8 adopted in this final rule differs ]

from the amendment of $60.8 in the proposed rule (60 FR 15180) in that the term " Paperwork Reduction Act of 1980," in the proposed l 1

rule, has been changed to the term " Paperwork Reduction Act of 1995" in the final rule.

Section 60.21. Content of anolication.  !

l l The DOE petition suggested that provision for accident l analysis might be accomplished by amendment of $60.311. The Commission, instead, is requiring an accident analysis as part of the content of the application section (i.e., 560.21). The i language requires that the application address the potential j dose, to any individual located on or beyond any point on the preclosure controlled area boundary, that is attributable to 1

i Category 2 design basis events. The procedure that is envisaged 32 i

is that the applicant would address the Category 2 design basis events, singly, and demonstrate, by its analysis, that the doses to any individual located on or beyond any point on the preclosure controlled area boundary would be in accordance with the applicable requirements. The language serves the same purpose as the counterpart section of Part 72 (namely, 10 CFR 72.24[m]).

The final rule also reflects the position that the applicant must demonstrate that the requirements of Part 20 and the EPA standards will be met, assuming the occurrence of Category 1 design basis events. For this analysis, the applicant would calculate the num of the doses, exposures, and releases from all Category 1 design basis events to ensure that these results do not exceed the limits specified in Part 20 and in the EPA standards.

The Commission also is eliminating certain terms in Part 60 that are undefined and may be subject to differing interpretations -- specifically, the terms " normal conditions,"

" anticipated operational occurrences," and " accidents." These terms are supplanted by the new term " design basis events."

Besides enhancing clarity of expression, the new language better reflects the articulated regulatory framework. Lastly, where the term " controlled area" appears in the language of this section, it is changed to "postolosure controlled area."

33

Section 60.43. License soecification.

The term " controlled area" is changed to "postclosure controlled area."

Section 60.46. Particular activities recuirina license amendment.

The term " controlled area" is changed to "postclosure csntrolled area."

Section 60.51. License amendment for oermanent closure.

The term " controlled area" is changed to "postclosure ,

i controlled area." )

Section 60.102. Concepts.

The term " controlled area" is changed to "postclosure controlled area." .

1 Section 60.111. Performance of the aeoloaic reoository operations area throuah normanent closure. I 34 l l

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

1 r

j The Commission is deleting the phrase "at all times" from the performance objective of $60.111(a). This change clarifies that this requirement does not apply to radiation exposures, i levels, and releases from Category 2 design basis events.

4 Section 60.121. Reauirements for ownershin and control of interests in land.

The term " controlled area" is changed to "postclosure controlled area."

Section 60.122. Sitina criteria.

The term " controlled area" is changed to "postclosure controlled area."

faction 60.130. Scone of desian critgria for the aeoloaic repository operations area.

The Commission is modifying the title of this section to the term " General Considerations" and is adding clarifying language, to the existing discussion, to indicate that $560.131 through 60.134 specify the minimum criteria for the design of those structures, systems, and components important to safety, or important to waste isolation. These changes are necessary to provide consistency with the modified definition of "important to 35

safety" (560.2), as well as to clarify the purpose of these criteria. These changes also provide consistency with the corresponding " minimum" design criteria, for an MRS, in Part 72.

Section 60.131. General desian criteria for the aeoloaic '

repository oDerations area.

Consistent with the modifications to $60.130, as described above, the Commission is deleting the reference to " Structures, systems, and components important to safety," in the title of

$60.131(b), and re-numbering the current criteria in S$60.131(b) (1) through 60.131(b) (10) , as appropriate. This change eliminates the confusion in the existing rule related to the identification of only the criteria in 560.131(b) as "important to safety." It also resolves the present incongruity with S60.131(b) (7) , " criticality control," regarding the reference to waste " isolation" (a postclosure term) in the requirement. I The current rule employs the term " normal and accident I conditions," or similar expression, in several places. However, the conditions that must be addressed under this language are not well-defined. The Commission is remedying this situation by replacing current terminology with references to " design basis events," thereby unsuring that the design appropriately takes i into account the consequences of all design basis events 36

(i.e., as discussed in this document, Category 1 and 2 design basis events). Accordingly, paragraphs (b) (5) (i) , (b)(7), and (b) (8) are modified for this section. The Commission also is revising the language in S60.131(b) (1), which refers to

" anticipated" natural phenomena and environmental conditions, so as to encompass all design basis events. The "necessary safety functions" that must be accommodated in the design, pursuant to that paragraph, include whatever is necessary to meet the quantitative limits set out in the Commission's rules (i.e., in S60.111(a) and $60.136).

As discussed under "Public Comments on the Proposed Rule,"

the Commission considers the applicability of the criticality control requirements in S60.131(h) to be clear with respect to preclosure considerations. The Commission also believes that uncertainty remains with respect to the applicability of the criticality control requirements to the postclosure period. The Commission intends to address the remaining uncertainty in a future rulemaking to make the NRC requirements consistent with the revised EPA standards that are currently under development, as mandated by the Energy Policy Act of 1992.

Section 60.132. Additional desian criteria for surface facilities in the ceoloalc repository operations area.

37

i Section 60.132 (c) (1) requires that the surface facilities  ;

must be "... designed to control the release of radioactive materials in effluents duririg normal operations so as to meet the 4

i performance objectives of S60.111(a)." The design should ordinarily be sufficient to provide reasonable assurance of

meetici Part 20 not only during normal operations, but even for events that are likely to occur moderately frequently or one or

) more times before permanent closure of the geologic repository l (i.e., all Category 1 design basis events). Deleting the phrase i

"during normal operations," broadens the scope of this provision  :

i l to reflect the Commission's intent more accurately.

4 j The amendment of $60.132 adopted in this final rule differs from the amendment of $60.132 in the proposed rule in that the phrase "in effluents" in the proposed rule was changed to "in effluents during Category 1 design basis events" in the final rule. The rationale for this change was discussed in the

" Response to Public Comments on the Proposed Rule."

Section 60.133. Additional desian criteria for the underaround facility.

As in the case of the changes to 10 CFR 60.131, a reference to design basis events is substituted for the less precise

" normal operations and ... accident conditions."

38 l

4 Rgg1}gn 60.136. Preclosure controlled area.

The final rule adopts the petitioner's concept of a preclosure control area under the name "preclosure controlled area." The tern' delimits an area over which the licensee exercises control of activities to meet regulatory requirements.

Control would include the ability to exclude members of the public, if necessary. The zone, and related dose limits, would also be used to analyze and identify structures, systems, and components that are important to safety under unusual conditions that have heretofore been characterized as Category 2 design basis events - credible, yet not likely to occur during the period of operations. The issue that is presented concerns the dose limits to ensure that the consequences of any events which occur present no unreasonable risk to the health and safety of the public. (Releases resulting from Category 1 design basis events would not be permitted to cause doses exceeding the limits of Part 20.) The Commission adopts the basic provisions of Part 72 - namely, a 0.05 Sv (5 rem) dose limit, on or beyond the preclosure controlled area boundary - as modified to reflect the Part 20 system of dose limits (see $20.1201[a]). In addition to providing for separate dose limits for individual organs and tissue, the lens of the eye, and the skin, the use of " total effective _ dose equivalent" (TEDE) in Part 20 explicitly accounts for exposures via the ingestion and inhalation dose pathways.

39

Modification of the 0.05 Sv (5 rem) dose limit, to reflect the Part 20 system of dose limits, results in a family of dose limits: a TEDE of 0.05 SV (5 rem); or the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue (other than the lens of the eye) of 0.5 Sv (50 res); an eye dose equivalent of 0.15 SV (15 rem) ; and a shallow dose equivalent, to skin, of 0.5 Sv (50 rem).2 The eye and skin dose limits are adequate to ensure that no observable effects (e.g., induction of cataracts in the lens of the eye) will occur as a result of any accidental radiation exposure. In implementing this provision, dose calculations should be made solely with reference to the consequence of the specific Category 2 design basis event, not cumulatively with other design '

basis events. To clarify this matter further, the analysis of a arecific Category 2 design basis event would require an analysis which includes an initiating event (e.g., an earthquake) and the associated combinations of repository system or component i

failures that can potentially lead to exposure of the public to radiation. An example design basis event is a postulated earthquake (the initiating event) which results in: (1) the failure of a crane lifting a spent fuel waste package inside a waste handling building, (2) damage to the building ventilation filtration system, (3) the drop and breach of the waste package, (4) damage to the spent fuel, (5) partitioning of a fraction of 3

Radiation exposure terminology is as used in Part 20 (56 FR 23360; May 21, 1991).

40 I

i 4

the radionuclide inventory to the building atmosphere, (6) release of some radioactive material through the damaged 4

ventilation filtration system, and (7) public exposure to the l l

released radioactive material. It should be noted that it is not [

necessary to assume multiple failures of safety-related systems unless these multiple failures are credible consequences of the initiating event. An analysis of a specific event for a real repository would be dependent on the particular features of the I facility design and related operating procedures. In general, t credit for the proper functioning of repository structures,  !

systems, and components in an analysis would be commensurate with the merits of the design. In.the example cited above, a waste  !

l package designated "important to safety" would not necessarily be assumed to breach in a drop event if the maximum hypothetical drop falls within the design parameters of the waste package to withstand such an event. Similarly, repository ventilation filtration systems would be analyzed for their capability to withstand natural phenomena (e.g., earthquakes) and detect, j isolate, or filter radioactive material in ventilation flow.

)

The only other noteworthy deviation from Part 72 is to refer in $60.136 to doses attributable to any " Category 2 design basis event" whereas the corresponding section (i.e., 10 CFR 72.106) in )

Part 72 refers to doses attributable to any " design basis I accident." The term " design basis event" is used because it is a defined term in Part 60. The change in terminology is not l l

41 l

i

v intended to be one of substance as Category 2 design basis events .

i would generally be considered as accidents.

The 0.05 Sv (5 rea)' dose limit is being adopted by the Commission as the appropriate design basis for protection of  ;

public health and safety from Category 2 design basis events at a j GROA and will harmonize Part 60 with Part 72. In this regard, ,

i the Commission notes that Part 72 applies to those facilities I (MRS installations) most similar to the surface facilities of a repository and for which the kinds of design basis events are - j also expected to be Jimilar. Further, the dose limit is consistent with dose values (0.06 Sv [6 rem) to the whole body) established as guidance for both fuel-handling accidents and  !

spent-fuel cask-drop accidents at nuclear power plants.8 Moreover, the dose limit is consistent with the accident-dose  ;

value (0.05 Sv [5 rem) effective dose equivalent) proposed by DOE in its PRM. <

However, while consistency between the proposed 0.05 Sv (5 ren) dose limit for Part 60 and other Commission rules or guidance documents is important, consistency alone does not {

necessarily ensure that there would be no unreasonable risk to  ;

the' health and safety of the public associated with the proposed limit. As such, a perspective is provided on the risks i

3 NUREG-0800, " Standard Review Plan for the Review of Safety Analysis ,

Reports for Nuclear Power Plants," June 1987.  !

42 i

associated with an operational repository and the appropriateness of the proposed 0.05 Sv (5 rem) dose limit as the design basis for protection of public health and safety from Category 2 design basis events.

Based on estimates provided by the National Council on Radiation Protection and Measurements', the lifetime risk to ,

l individuals in the general population is 0.05 fatal cancers per Sv of expustre. Therefore, the lifetime risk of fatal cancer from an assumed 0.05 Sv (5 rem) exposure resulting from a postulated Category 2 design basis event is 0.0025 (i.e., 2.5 x 10-3) per individual exposed. While this asseesment provides perspective on the risk associated with a hypothetical exposure i

of a 0.05 Sv (5 rem) dose, it does not provide perspective on the estimated actual risk associated with the spectrum of possible Category 2 design basis events at a repository during its

]

operational lifetime (estimated to be about 100 years).

l l

l Perspective on actual risk must include consideration of the frequencies (i.e., probabilities) of occurrence of these events, as well as their consequences, as " risk" is defined as "the probability of an event times its consequences." With respect to the range of probabilities of category 2 design basis events, the National Council on Radiation Protection and Measurements, " Risk Estimates for Radiation Protection," NCRP Report No. 115, December 31, 1993.

1 l 43 1

i 1 /

l upper bound is roughly 1 x 10-2 per year (i.e., events with probabilities of occurrence greater than 1 x 10-2 per year would I

I generally be considered to be category 1 events). Accordingly, f assuming event consequences equivalent to the 0.05 Sv (5 rea) dose limit for Part 60, the hypothetical upper bound on [

j individual risk is 2.5 x 10~5 fatal cancers per year. To put  !

I, this risk in perspective, the International commission on i .

Radiological Protection 5 notes that, based on a review of

{ i j information related to risks regularly accepted in everyday life j

! I i for stochastic phenomena, a fatal cancer risk in the range of 1

l 1 x 10 to 1 x 10-5 per year from exposure to radiation would l likely be acceptable to individual members of the public. Thus, l l t while the risk associated with the consequences of a repository  !

event at the dose limit and upper bound probability of occurrence

exceeds this range by a small factor, and is at a level that the ,

i  !

i commission considers safe for occupational exposures, the  !

i  !

Commission believes this result significantly overestimates the 1 actual risk of an operating repository. Similarly, the j Commission considers that the lower bound of category 2 design I d  :

l basis events is on the order of 1 x 10~' per year (i.e. , events )

5 i

! with probabilities of occurrence less than 1 x 10-' per year I i

! would generally be screened from further consideration due to i

their negligible contribution to overall risk). In the proposed rule (March 22, 1995; 60 FR 15180), the commission had considered 5

Reconsendations of the International Commission on Radiological Protection. ICRP Publication 26, January 1977.

44

i

)

e a probability of occurrence of 1 x 10" per year as an appropriate lower bound. However, upon further analysis as discussed below, the Commission considers that a lower bound of 1 x 10" per year is too low and unjustified, and that a lower bound of 1 x 10' per year is appropriate. Screening out events with probabilities of less than 1 x 10-' is expected to provide conservative estimates of risk. A higher screening criterion could probably be justified given the magnitude of the consequences and risks from this facility, but this criterion is i

l not expected to cause an excessive analytical burden for demonstating compliance with 560.136, consistent with the Commission's guidance on the application of probability risk assessment methods in licensing. It is important to note that the arguments advanced for this screening criterion apply solely to the period of repository operations before permanent closure.

l Assuming bounding repository event consequences of roughly l 0.2 SV (20 rem), a lifetime risk to individuals in the general i

population of 0.05 fatal cancers per Sv of exposure, and a lower bound of 1 x 10-' per year for the probability of occurrence of category 2 design basis events, the estimated risk of cancer l

l fatality from these low probability events would be 1 x 10-8 per year. Events which result in risks at or below this

level do not contribute significantly to repository risk to an 1

a 45 1

l l

k individual and, as such, can be neglected in the overall risk assessment.

Perspective on actual repository risk can be obtained by developing an understanding of the spectrum of potential Category 2 design basis events and estimating the consequences of these sequences, as well as their probabilities of occurrence. ,

i In this regard, the commission recognizes that there is no l i

high-level waste repository operating experience, and that only conceptual designs have been developed for these facilities.

Nonetheless, some perspective can be gained from the preliminary risk assessment by DOE' of a conceptual design for a repository at Yucca Mountain, Nevada, as well as from consideration of risk  ;

I assessments of selected U.S. nuclear power plants.7 Consistent with risk assessments for nuclear power plants, the spectrum of possible repository design basis events includes both internally and externally initiated events. Internally initiated events would include waste transporter collisions, crane failures or other types of fuel assembly, waste package or cask drop events, building or facility exhaust filter fires, and exhaust filter bypass or failure. Externally initiated events U.S. Department of Energy, " Site Characterization Plan, Yucca Mountain Site, NevaJa Research and Development Area, Nevada,"

DOE /RW-0199, December 1988.

7 NUREG-Il50, " Severe Accident Risks: An Assessment for Five U.S. Nuclear Power Plants," December 1990.

46

1 l

l t

i would' include those resulting from earthquakes, tornados, and

{

flooding. Regardless of the type or nature of the initiating j event, the Commission believes that, for several reasons, both the variety of credible events and the resulting potential consequences to members of the public will be somewhat limited at repository facilities. First, in comparison with a nuclear power plant, an operating repository is a relatively simple facility in which the primary activities are waste receipt, handling, storage, and emplacement. A repository does not require the variety and complexity of active systems necessary to support an

]

operating nuclear power plant. Further, the conditions are not present at a repository to generate a radioactive source term of a magnitude that, however unlikely, is potentially capable at a nuclear power plant (e.g., from a postulated loss of coolant event). As such, the estimated consequences resulting from limited source term generation at a repository would be correspondingly limited. This conclusion is consistent with the results of the aforementioned preliminary risk assessment by DOE of a conceptual repository design at Yucca Mountain, Nevada. In that assessment, DOE considered 149 events for a variety of internally and externally initiated events. Of the 149 events, i

only 7 resulted in offsite doses in excess of 0.005 Sv (0.5 rem) l to the critical organs of a maximally exposed individual and also  !

had associated probabilities of occurrence greater than 1 x 10

per year. The highest estimated offsite dose from the DOE risk I 47

6 assessment was 0.021 Sv (2.1 rem) with an associated probability of occurrence of 5 x 10-7 per year.

1 The dose estimates of the DOE risk assessment are only reflective of a conceptual design for a repository at Yucca Mountain, Nevada. Nonetheless, the Commission believes they

provide perspective on the magnitude of the estimated

consequences to members of the public from postulated Category 2 design basis events, and that variations in repository design or site selection would not likely vary these estimates by more than an order of magnitude. The results of the DOE risk assessment also provide some perspective on the estimated probabilities of occurrence of the postulated repository design basis events and, s

4 as such, perspective on actual risk from an operating repository. ,

In general, the Commission would expect the potential higher consequence events to have correspondingly lower probabilities of occurrence. This expectation is consistent with the results of the DOE risk assessment as the estimated probabilities of occurrence for the seven events which resulted in offsite doses  ;

in excess of 0.005 Sv (0.5 rem) vary from 1 x 10 to 5 x 10~' per l year. The corollary to this is the expectation that higher frequency events would have correspondingly lower offsite consequences, and perspective on actual risk from an operating repository necessitates consideration of these events, as well as lower frequency events. Review of the DOE risk assessment 48

4 indicates that some higher frequency, but lower consequence, events are just as important to actual risk as the lower ,

1 frequency, but higher consequence, events. With respect to actual risk from the broad spectrum of all events considered in i l

i j the DOE risk assessment, the estimated actual risk of an 1  :

5 operating repository is roughly two to three orders of magnitude lower than the range of fatal cancer risks that would likely be acceptable to members of the public (i.e., a fatal cancer risk of

{ 1 x 10-' to 1 x 10-5 per year as noted in ICRP Publication 26).

l

)

J With respect to the appropriateness of the proposed 0.05 Sv j I

l (5 rem) dose limit for Part 60 as the design basis for protection

) of public health and safety from Category 2 design basis events, i

! the DOE risk assessment indicates the potential for events with l offsite consequences on the order of several hundredths to i

several tenths of Sv (several rem to several tens of rem),

l ' depending on design and siting factors. The event consequences l i

l in this range, coupled with the estimated event probabilities of occurrence, result in estimated risks that would likely be i acceptable to members of the public. However, given the lack of j repository design, siting and operating experience and the supporting data base for probabilistic risk assessment, the i Commission believes there is considerable uncertainty in the i

estimates of both the consequences and the probabilities of i

occurrence of postulated Category 2 design basis events. As

) such, the Commission believes that establishing a dose limit in J

49 t

M

4 Part 60 to the 0.05 SV (5 rem) value would provide an adequate 3

margin of safety and an appropriate design basis for protection of members of the public from unlikely, but credible events.

Further, the Commission believes that a single dose limit is appropriate for the oroad range of possible event frequencies,

, given the limited potential for offsite consequences at '

repository facilities.

Lastly, the amendments of $60.136 adopted in this final rule differ slightly from the amendments of $60.136 proposed in the proposed rule (60 FP 15180) in that the phrase "on or beyond the nearest boundary" in the proposed rule was changed to "on or l beyond any point on the boundary" in the final rule and the phrase "may not exceed" in the proposed rule was changed to "shall not exceed" in the final rule. The rationale for the ,

l latter change is to improve clarity and the rationale for the former change was discussed earlier in the " Response to Public Comments on the Proposed Rule."

Section 60.183. Criminal oenalties.

j l In the proposed rule, a conforming change was made to this section to include $60.136 (pertaining to the preclosure controlled area) among the regulations that are not issued under Sections 161b, 1611, or 161o of the Atomic Energy Act, for purposes of Section 223 of the Act. On reconsideration, the 4

50

r Commission has decided not to revise this section (i.e., criminal

penalties are authorized for violations of $60.136).

Small Business Regulatory Enforcement Fairness Act i

, In accordance with the Small Business Regulatory Enforcement Fairness Act of 199G, the NRC has determined that this action is ,

not a major rule and has verified this determination with the l

Office of Information and Regulatory Affairs of OMB. )

I Environmental Impact: Categorical Exclusion  ;

l l

The NRC has determined that this regulation is the type of {

action described in 10 CFR 51.22 (c) (2) , pertaining to the promulgation of technical requirements and criteria that the commission will apply in approving or disapproving applications under Part 60. Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

Paperwork Reduction Act Statement 1

This final rule does not contain a new or amended l information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et sea.). Existing requirements were approved by OMB, approval number 3150-0127.

I i

51

)

l Public Protection Notification The NRC may not conduct or sponsor, and a person is not required  ;

l to respond to, a collection of information unless it displays a currently valid OMB control number.

1 1

4 Regulatory Analysis 1

l The Commission has prepared a regulatory analysis on this final rule. The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is j available for inspection in the NRC Public Document Room, 2120 L Street NW (Lower Level) , Washington, DC. Single copies of the analysis may be obtained from Dr. Richard A. Weller, U.S.

Nuclear Regulatory Commission, Office of Nuclear Material Safety l and Safeguards, Division of Waste Management, Washington, I DC 20555, Telephone (301) 415-7287.

1 Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule will not have a significant economic impact on a substantial number of j small entities. The only entity subject to regulation under this I i

rule is DOE.

52 l

1 I

s Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this final rule and, therefore, that a backfit analysis is not required for this final rule, because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109 (a) (1) .

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

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. 552 and 553, the NRC is adopting the following amendments to Part 60.

53

b PART 60 - DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES  ;

IN GEOLOGIC REPOSITORIES

1. The authority citation for Part 60 is amended 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 (42 U.S.C. 2021a and 5851) ; sec. 102, Pub. L.91-190, 83 Stat. 853 ( 4'd U. S . C.  !

4332); secs. 114, 121, Pub. L.97-425, 96 Stat. 2213 t), 2228, as amended (42 U.S.C. 10134, 10141), and Pab. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851).

i

2. Section 60.2 is amended by adding definitions of " Design bases," " Design basis events," and "Preclosure controlled area,"

revising the definitions of " Accessible environment," " Disturbed zone," "Important to safety," and " Site," revising the name of the defined term " Controlled area" to "Postclosure controlled l area" and presenting this renamed term without change for the convenience of the user, and alphabetizing the definitions to l l

read as follows:

l l 54 l

l I

I l

6

$60.2. Definitions. i Accessible environment means:

(1) The atmosphere; 4 (2) The land surface; (3) Surface water; (4) Oceans; and (5) The portion of the lithosphere that is outside the i t

postclosure controlled area. i Desian bases means that information that identifies the specific functions to be performed by a structure, system, or l component of a facility and the specific values or ranges of j l values chosen for controlling parameters as reference bounds for design. These values may be restraints derived from generally accepted " state-of-the-art" practices for achieving functional goals or requirements derived from analysis (based on calculation l i or experiments) of the effects of a postulated event under which a structure, system, or component must meet its functional goals.

The values for controlling parameters for external events s l include:

i (1) Estimates of severe natural events to be used for I

' l deriving design bases that will be based on consideration of j j historical data on the associated parameters, physical data, or l 1

analysis of upper limits of the physical processes involved; and )

l i

55 1

~

l (2) Estimates of severe external man-induced events, to be used for deriving design bases, that will be based on analysis of human activity in the region, taking into account the site characteristics and the risks associated with the event.

L l Desian basis events means:

(1) (1) Those natural and human-induced events that are  !

reasonably likely to occur regularly, moderately frequently, or one or more times before permanent closure of the geologic repository operations area; and

! (ii) Other natural and man-induced events that are

} considered unlikely, but sufficiently credible to warrant consideration, taking into account the potential for significant radiological impacts on public health and safety.

1 (2) The events described in paragraph (1) (i) of this  ;

definition are referred to as " category 1" design basis events.

l The events described in paragraph (1) (11) of this definition are referred to as " Category 2" design basis events.

Disturbed zone means that portion of the postclosure controlled area, the physical or chemical properties of which have changed as a result of underground facility construction or as a result of heat generated by the emplaced radioactive wastes, such that the resultant change of properties may have a significant effect on the performance of the geologic repository.

56

O Innortant to safety, with reference to structures, systems, and. components, means those engineered features of the repository i

whose function is:

)

)

(1) To provide reasonable assurance that high-level waste can-be received, handled, packaged, stored, emplaced, and retrieved without exceeding the requirements of $60.111(a) for category 1 design basis events; or 1

(2) To prevent or mitigate Category 2 design basis events that could result in doses equaloto or greater than the values spe~lfied in $60.136 to any individual located on or beyond any point on the boundary of the preclosure controlled area.

Postclosure controlled area means a surface location, to be marked by suitable monuments, extending horizontally no more than 10 kilometers in any direction from the outer boundary of the underground facility, and the underlying subsurface, which area has been committed to use as a geologic repository and from which incompatible activities would be restricted following permanent l closure. I Preclosure controlled area means that surface area surrounding the geologic repository operations area for which the licensee exercises authority over its use, in accordance with the 57

~ . - - . - - . . . .

I i 4

l

't I I

provisions of'this part, until permanent closure has been

! completed. )

l j * * * *

• Restricted area means an area, access to which is limited by  ;

j the licensee for the purpose of protecting individuals against '

] undue risks from exposure to radiation and radioactive materials. l 1

Restricted area does not include areas used as residential

]

quarters, but separate rooms in a residential building may be set i aside as a restricted area.

4 I

Site means the location of the preclosure controlled area, 1

I or of the postclosure controlled area, or both.

! Unrestricted area means an area, e.ccess to which is neither j i

l limited nor controlled by the licensee.

}

i 1

j 3. Section 60.8 is revised to read as follows:

560.8 Information Collection Requirements: Approval.

s l (a) The Nuclear Regulatory Commission has submitted the information collection requirements of general applicability contained in this part to the office of Management and Budget for j approval as required by the Paperwork Reduction Act of 1995  !

! (44 U.S.C. 3501, et sea.). The Office of Management and Budget  ;

i J

i 58 l w rn -+- --

4 --t

J has approved the information collection requirements contained in  ;

this part under control number 3150-0127.

(b) The approved information collection requirements contained in this part appear in $560.62, 60.63, and 60.65.

4. In $60.21, paragraphs (c) (1) (i) , (c) (1) (li) (B) , . (c) (3) ,

and (c) (8) are revised to read as follows:

560.21. Content of application.

(c) * * *

(1) *

(i) The description of the site shall also include the following information regarding subsurface conditions. This description shall, in all cases, include this information with respect to the postclosure controlled area. In addition, where subsurface conditions outside the postclosure controlled area may affect isolati.a within the postclosure controlled area, the description shall include information with respect to subsurface l

conditions outside the postclosure controlled area to the extent l 1

the information is relevant and material. The detailed l information referred to in this paragraph shall include:

1 (A) The orientation, distribution, aperture in-filling and origin of fractures, discontinuities, and heterogeneities; i

59 e

v 1 (B) The presence and characteristics of other potential pathways such as solution features, breccia pipes, or other potentially permeable features; i

i (C) The geomechanical properties and conditions, including  ;

pore pressure and ambient stress conditions;  !

(D) The hydrogeologic properties and conditions; I

(E) The geochemical properties; and  !

(F) The anticipated response of the geomechanical, hydrogeologic, and geochemical systems to the maximum design thermal loading, given the pattern of fractures and other i discontinuities and the heat transfer properties of the rock mass and groundwater.

(ii)

(B) 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. For the purpose of determining the  !

presence of the potent lally adverse conditions, investigations i shall extend from the surface to a depth sufficient to determine 1 l

critical pathways for radionuclide migration from the underground j facility to the accessible environment. Potentially adverse 60 l

j

conditions shall be~ investigated outside of the postclosure controlled area if they affect isolation within the postclosure controlled area.

(3)- A description and analysis of the design and performance requirements for structures, systems, and components of the geologic repository that are important to safety. The analysis must include a demonstration that --

(1) The requirements of $60.111(a) will be met, assuming occurrence of Category 1 design basis events; and (ii) The requirements of $60.136 will be met, assuming occurrence of Category 2 design basis events.

(8) A description of the controls that the applicant will apply to restrict access and to regulate land use at the site and adjacent areas, including a conceptual design of monuments which.

would be used to identify the postclosure controlled area after

-permanent closure.

$60.43 [ Amended)

5. In $60.4 3 (b) (5) , the term " controlled area" is revised to read "postclosure controlled area."

$60.46 [ Amended) 61

4

6. In $60.46(a) (3) , the term " controlled area" is revised {

to read "postclosure controlled area."

560.51 (Amended)  ;

7. In $60.51(a) (2) (1) and (a) (2) (ii) , the term " controlled area" is revised to read "postclosure controlled area." ,

560.102 [ Amended) p

8. In 560.102(c), the term " controlled area" is revised to read "postclosure controlled area."

9. In S60.111, paragraph (a) is revised to read as follows:

4 b

$60.111. Performance of the geologic repository operations area throtgh permanent closure.

(a) Protection aaainst radiation exoosures and releases of  ;

radioactive material. The geologic repository operations area shall be designed so that until permanent closure has been completed, radiation exposures and radiation levels, and releases of radioactive materials to unrestricted areas, will be maintained within the limits specified in Part 20 of this chapter and such generally applicable environmental standards for 62 j

1 a

radioactivity as may have been established by Environmental Protection Agency.

I J

s i

$60.121 (Amended) r

10. In ' 560.121 ( A) and (b) , the term "controJ1ed area" is  !

' revised to read "postclosura controlled area."

i

$60.122 (Amended) ,

11. In S60,122 (b) (6) and (c), the term " controlled area" is revised to read "postclosure controlled area."

12. Section 60.130 is revised to read as follows: I t

560.130 General considerations.

Pursuant to the provisions of $60.21(c) (2) (i), an application to receive, possess, store, and dispose of high-level I radioactive waste in the geologic repository operations area must j include the principal design criteria for a proposed facility.

The principal design criteria establish the necessary design, fabrication, construction, testing, maintenance, and performance requirements for structures, systems, and components important to l safety and/or important to waste isolation. Sections 60.131 through 60.134 specify minimum requirements for the principal 63

I design criteria for the geologic repository operations area.

i These design criteria are not intended to be exhaustive.

1 However, omissions in SS60.131 through 60,134 do not relieve DOE from any obligation to provide such features in a specific facility needed to achieve the performance objectives.

13. In 560.131, paragraph (b) is revised, and paragraphs (c) through (k) are added to read as follows:

l

$60.131. General design criteria for the geologic repository operations area.

(b) Protection acainst desian basis events. The structures, systems, and components important to safety shall be designed so that they will perform their necessary safety functions, assuming occurrence of design basis events.  !

(c) Protection acainst dynamic effects of eculoment failure and similar events. The structures, systems, and components important to safety shall be designed to withstand dynamic effects such as missile impacts, that could result from equipment failure, and similar events and conditions that could lead to loss of their safety functions.

(d) Protection acainst fires and explosions.

64

i i .

i 0- t (1) The structures, systems, and components important to l

safety shall be designed to perform their safety functions during and after credible fires or explosions in the geologic repository I

operations area.

i i i i j (2) To the extent practicable, the geologic repository  :

l operations area shall be designed to incorporate the use of  ;

l l noncombustible and heat resistant materials. j

{ (3) The geologic repository operations area shall be  !

I i designed to include explosion and fire detection alarm systems  ;

i and appropriate suppression systems with sufficient capacity and i

! capability to reduce the adverse effects of fires and explosions 1

j on structures, systems, and components important to safety.  !

a l

(4) The geologic repository operations area shall be designed to include means to protect systems, structures, and components important to safety against the adverse effects of either the operation or failure of-the fire suppression systems.

(e) Emeraency capability.

(1) The structures, systems, and components important to safety shall be designed to maintain control of radioactive waste l

and radioactive effluents, and permit prompt termination of I I

operations and evacuation of personnel during an emergency.

65

e (2) The geologic repository operations area shall be designed to include onsite facilities and ser" ices that ensure a safe and timely response to emergency conditions and that facilitate the use of available offsite services (such as fire, police, medical, and ambulance service) that may aid in recovery from emergencies.

(f) Utility services (1) Each utility service system that is important to safety shall be designed so that essential safety functions can be performed, assuming occurrence of the design basis events.

(2) The utility services important to safety shall include redundant systems to the extent necessary to maintain, with adequate capacity, the ability to perform their safety functions.

(3) Provisions shall be made so that, if there is a loss of the primary electric power source or circuit, reliable and timely emergency power can be provided to instruments, utility service systems, and operating systems, including alarm systems, important to safety.

(g) Inspection, testina, and maintenance. The structures, systems, and components important to safety shall be designed to 66

I i

. L a

permit periodic inspection, testing, and maintenance, as necessary, to ensure their continued functioning and readiness.

(h) criticality control. All systems for processing, transporting, handling, storage, retrievci, emplacement, and j isolation of radioactive waste shall be designed to ensure that nuclear criticality is not possible unless at least two unlikely, independent, and concurrent or sequential changes have occurred  !

in the conditions essential to nuclear criticality safety. Each l

system must be designed for criticality safety assuming l

occurrence of design basis events. The calculated effective i

multiplication factor (k.rt) must be sufficiently below unity to j show at least a 5 percent margin, after allowance for the bias in l

the method of calculation and the uncertainty in the experiments used to validate the method of calculation.  ;

I (i) Instrumentation and control systems. The design shall include provisions for instrumentation and control systems to monitor and control the behavior of systems important to safety, assuming occurrence of design basis events.

1 (j) Compliance with minina reculations. To the extent that j l

DOE is not subject to the Federal Mine Safety and Health Act of i 1977, as to the construction and operation of the geologic repository operations area, the design of the geologic repository i

operations area shall nevertheless include provisions for worker 67  ;

sl protection necessary to provide reasonable assurance that all structures, systems, and components important to safety can perform their intended functions. Any deviation from relevant design requirements in 30 CFR, Chapter I, Subchapters D, E, and N will give rise to a rebuttable presumption that this requirement has not been met.

(k) Shaft convevances used in radioactive waste handlina.

(1) Hoists important to safety shall be designed to preclude cage free fall.

(2) Hoists important to safety shall be designed with a reliable cage location system.

5 1

(3) Loading and unloading systems for hoists important to safety shall be designed with a reliable system of interlocks that will fail safely upon malfunction.

(4) Hoists important to safety shall be designed to include two independent indicators to indicate when waste packages are in place and ready for transfer.

14. In S60.132, paragraph (c) (1) is revised to read as follows:

68

a:

$60.132. Additional design criteria for surface facilities in i the geologic repository operations area.

4 1

j (c) Radiation control and monitorina - (1) Effluent control. i The surface facilities shall be designed to control the release of radioactive materials in effluents during Category 1 design basis events so as to meet the performance objectives of [

560.111(a). .

4 * * * * *

15. In S60.133, the introductory texts of paragraph (g) and {

l paragraph (g)(2) are revised to read as follows:

i 560.133 Additional design criteria for the underground facility. i (g) Undercround facility ventilation. The ventilation i i

system shall be designed to:

t a

(2) Assure the ability to perform essential safety functions

assuming occurrence of design basis events.

l I

16. A new undesignated center heading and 560,136 are added

)

to read as follows:

Preclosure Controlled Area b l

, 69 i

i

.r a

560.136 Preclosure controlled area.

I (a) A preclosure controlled area must be established for the geologic repository operations area.

(b) The geologic repository operations area shall be designed so that, for Category 2 design basis events, no individual located on or beyond any point on the boundary of the preclosure controlled area will receive the more limiting of a total effective dose equivalent of 0.05 Sv (5 rem), or the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue (other than the lens of the eye) of 0.5 SV (50 rem). The eye dose equivalent shall not exceed 0.15 SV (15 rem), and the shallow dose equivalent to skin shall not exceed 0.5 SV (50 rem). The minimum distance from the surface facilities in the geologic repository operations area to the boundary of the preclosure controlled area must be at least 100 meters $

(c) The preclosure controlled area may be traversed by a highway, railroad, or waterway, so long as appropriate and effective arrangements are made to control traffic and to protect public health and safety.

70

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

1

'I

+

Dated in Rockville, Maryland, this day of , 1996.

5 For the Nuclear Regulatory Commission.  !

i 4

i i  !

, John C. Hoyle, Secretary of the Cormission.  ;

I i 1 n n

[

i I

b t

.c l

l 71

-n .v. , -- , - ,.

1 e

l ANALYSIS OF COMMENTS ON PROPOSED RULE I

4

)

l PUBLIC COPMENTS AND NUCLEAR REGULATORY COMMISSION (NRC) RESPONSES ON THE

" DESIGN BASIS EVENTS" PROPOSED RULE (60 FR 15180)

Ten sets of comments were received on the proposed rule from the following organizations and individuals: (1) The Clean Water Fund of North Carolina; (2)

Mr. Vernon J. Brechin; (3) U.S. Department of Energy (DOE), Office of Civilian Radioactive Waste Management; (4) U.S. Environmental Protection Agency (EPA),

Cffice of Federal Activities; (5) Nye County, Nevada, Nuclear Waste Repository  :

Project Office; (6) Virginia Power Company; (7) Nuclear Energy Institute; I (8) Environmental Coalition on Nuclear Power; (9) Wisconsin Electric Power Company; and (10) Mr. Marvin I. Lewis.

This document lists the individual comments, and provides the Nuclear Regulatory Commission's response. Responses are arranged in the order that comments were received by NRC (i.e., the above listed order), with the exception of the DOE comments, which appear first, as DOE was the petitioner.  ;

Oraanization/ Individual Eagg Department of Energy 1 Clean Water Fund of North Carolina 15 -

Vernon J. Brechin 18 U.S. Environmental Protection Agency, Office of Federal Activities 20 Nye County, Nevada, Nuclear Waste Repository Project Office 21 Virginia Power Company 22 Nuclear Energy Institute 25 Environmental Coalition on Nuclear Power 27 Wisconsin Electric Power Company 42 Marvin I. Lewis 43 l

t DEPARTMENT OF ENERGY CONMENT DEFINITION OF CONTROLLED AREA "The discussion refers to the controlled area as one '... (within which waste isolation is to be ensured after permanent closure).' This is inconsistent with the 10 CFR Part 60 definition of controlled area, which does not refer to waste isolation. Instead, the regulation describes the controlled area as the surface location and underlying subsurface '... from which incompatible

activities would be restricted following permanent closure.' The Department

, recommends that the Commission delete the parenthetical phrase in the i supplementary information."

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NRC RESPONSE NRC agrees that the parenthetical phrase does not properly characterize the definition of controlled area. !!owever, rather than deleting the

l. parenthetical phrase altogether, NRC will modify the phrase to accurately j reflect the definition of controlled area and its focus on postclosure

activities.

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!- DEPARTNENT OF ENERGY CONNENT i .;

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j IRN.TIPLE FAILURE SCENARIOS i  !

i "The supplementary information under 160.136 seems to indicate that multiple l l independent failure scenarios would be considered to be Category 2 design  !

4 basis events. The example cited is a postulated earthquake (initiating  ;

j event), resultant failure of a crane lifting a spent fuel waste package, drop  ;

and breach of the waste package, damage to the spent fuel and release of '

fission products to the waste handling building atmosphere, failure of the  !

building filtration system, and public exposure to radioactive material. l l Typically nuclear safety analyses are not required to assume multiple failures f'

! of safety-related systems unless they are all credible consequences of the j initiating event. Therefore, the Commission should clarify how it intends to #

1 review the acceptability of repository systems, structures, and components in  !

the context of the new rule. Would the Commission allow credit for the proper  !

functioning of important to safety systems, structures, and components to i mitigate the example scemrio? In other words, would the Commission require the Department to assume a waste package breach if the package is designated i important to safety and designed to withstand the initiating event? If so, ,

! this is a significant departure'from traditional nucle:.r power plant practice, i j and should be evaluated in detail in the regulatory analysis that is 1

associated with the proposed rule." f i

l NRC RESPONSE 4

l NRC intends to develop detailed guidance that will describe how the staff will i review the analyses in the license application to demonstrate compliance with i

the requirements of $60.136. This guidance will include specific review plans '

for selected Category 2 design basis evepts that will be incorporated into the ,

staff's License Application Review Plan. Although such guidance has not yet been developed, NRC can, nonetheless, provide some clarifying information ,

j herein on review methodology for Category 2 design basis events.

4 i NRC did not intend to imply that multiple independent failures would have to

! be considered in the analysis of a Category 2 design basis event. As noted in

! the Statement of Considerations for the proposed rule (60 FR 15186), in i implementing the requirements of 160,136, "... dose calculations should be made 4

solely with reference to the consequence of the specific Category 2 design

basis event, and not cumulatively with other design basis events." In the discussion of this matter in the Statement of Considerations, NRC provided an example of an event for illustrative purposes only as no information was l provided with respect to the magnitude of the postulated earthquake (i.e., the 4

k License Application Review Plan for a Geologic Repository for Spent j Nuclear Fuel and High-Level Radioactive Waste, NUREG-1323, Rev. O,

( September 1994.

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i initiating event), the design bases of the systems responding to the earthquake (i.e., the waste package, waste handling building, and building filtration system), or their susceptibility to common cause failure. An analysis of a specific event for a real repository, including assumptions regarding structure, system, and component performance or failure, would be dependent on the particular features of the facility design and related operating procedures.

In general, credit for the proper functioning of repository structures, systems, and components in an analysis would be commensurate with the merits of the design. For example, a waste package designed as "important to safety" would not necessarily be assumed to breach in a drop event if the maximum hypothetical drop'were to fall within the design parameters of the waste package to withstand such an event. Similarly, repository ventilation systems would be analyzed for their capability to withstand natural phenomena (e.g., earthquakes) and detect, isolate, or filter radioactive material in ventilation flow. The example Category 2 design basis event in the Statement of Considerations will be modified to clarify NRC's intent in the implementation of 660.136.

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c-DEPARTMENT OF ENERGY COMMENT PROBA8ILITY BOUNDS FOR CATEGORY 2 DESIGN BASIS EVENTS "The supplementary information under 660.136 indicates that the bounds for Category 2 events are considered to be roughly lx10 per probability year and lx10 4 per year. The lower bound is much too low and unjustified. For nuclear power reactors, facilities with a compara hazard level, the lower cutoff is typically lx10'pleper lifetime reactorand yeara higher (see ANSI /ANS-51.1-1983). NRC's August 21, 1986 Policy Statement ' Safety  ;

Goals for the Operation of Nuclear Power Plants' provided as a guideline that I

... the overall mean frequency of a large release of radioactive materials to the environment from a reactor accident should be,less than 1 in 1,000,000 per year of reactor operation.' A lower bound of 10 is very conservative for a repository and is more in line with standard industry practices and the Comission's guidance. Consideration of extremely unlikely accidents with probabilities below lx10 per year could significantly impact the repository design and design process without providing any commensurate benefit to public health and safety. Therefore, the Department recommends that approxi probapilityboundsforCategory2eventsbeestablishedbetweenlx10'pate and lx10' per year."

NRC RESPONSE NRC agrees that the range of probabilities of Category 2 design basis event, which should be considered in repository risk assgssment, can be established between the approximate bounds of 1x10' and lx10' per year. The establishment of bounds for event probabilities of occurrence is needed to distinguish between what should be considered and what can be neglected in assessing the risks associated with postulated Category 2 design basis event at an operating repository. Similar bounds or " cutoff criteria" have been suggested for the conduct of nuclear power reactor probabilistic safety assessments that are used to identify means for further risk reducti otherwise, make determinations about the adequacies of plant design.g or, In any probabilistic safety assessment, whether for a nuclear power reactor or a repository, it is important that all significant contributions to risk be taken into account in the assessment. In this regard, NRC noted, in the Statement of Considerations for tpe proposjd rule (60 FR 15186) that a fatal cancer risk in the range of lx10' to lx10 per year from exposure to radiation would likely be acceptable to individual members of the public. On this basis, risk values from Category 2 design basis event that are two or more , orders of magnitude below the above range (i.e., risks in the range of 1x10' to lx10'7) would not contribute appreciably to the overall risk of an operating repository and, therefore, can be neglected in the risk assessment.

" Special Committee Review of the Nuclear Regulatory Commission's Severe Accident Risks Report (NUREG-1150), NUREG-1420, August 1990.

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NRC also noted in the Statement of Considerations for the proposed rule l' (60 FR 15187) that the potential exists for repository Category 2_ design basis event with offsite consequences on the order.of several hundredths to several tenths Sv. Assuming bounding repository event consequences of roughly 0.2 Sv (20 res), a lifetime risk to individuals in the general population of 0.05-fatal cancers per Sv .of exposure, as e Radiation Protection and Measurements,gtimated and a lowerby the National bound Council of lx10' per year on for the probability of occurrence of Category 2 design basis ever.t, the estispted risk of cancer fatality from these low probability event would be lx10 per year. Events that result in risks at or below this level do not contribute significantly to repository risk to an individual and, as such, can be neglected in the overall risk assessment. Accordingly, NRC considers that it is appropriate to establish a lower bond or cutoff criterion for the probability of occurrence of Category 2 design basis event under consideration in repos oflx10)toryriskassessment.

per year would peruitA lower eventsbound frequency lower with frequencies or cutoff thanonthis thevalue order to be screened from further consideration due to their negligible contribution tooverfil risk. Screening out events with probabilities _of less than 1 x 10' is expected to provide conservative estimates of risk. A higher screening criterion could probably be justified given the magnitude of the consequences and risks from this facility, but this criterion is not expected to cause an excessive analytical burden for demonstating compliance with 160.136, consistent with the Commission's guidance on the application of probability risk assessment methods in licensing. It is important to note that the arguments advanced for this screening criterion apply solely to the period of repository operations before permanent closure.

" National Council on Radiation Protection and Measurements, " Risk Estimates for Radiation Protection," NCRP Report No. 115, December 31, 1993.

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DEPARTMENT OF ENERGY COMMENT i

i DEFINITION OF IMPORTANT TO SAFETY - ENGINEERED FEATURES i "The phrase ' engineered structures, systems, and components,' currently in the definition of important to safety, has been removed from proposed new definition. However, it is clearly the intent of the regulation to apply the definition to engineered systems, not natural systems.

The Department recommends that the definition be modified as follows:

l Important to safety, with reference to structures, systems, and components, mians those whose function is ...g" g[@@ features of the repository NRC RESPONSE

l NRC agrees with the comment and will modify the definition of "important to safety" as suggested above.

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DEPARTMENT OF ENERGY COMMENT APPLICABILITY OF ENVIR0000 ENTAL PROTECTION AGENCY STANDARDS FOR MANAGEMENT AND STORAGE OF HIGH-LEVEL WASTE '

"The definition of important to safety it, 560.2 refers to features of the repository whose function is '... to provide reasonable assurance that high-level waste can be received, handled, ... without exceeding the requirements of 560.lll(a) for Category I design basis events.' 60.lll(a) references two requirements: 10 CFR Part 20 and '... such generally applicable environmental standards for radioactivity as may have been l established by the Environmental Protection Agency.' It should be noted that the current EPA dose limit in 40 CFR Part 191, Subpart A, differs from the effective dose equivalents used in 10 CFR Part 20. The Department notes that  ;

the current proposed rule does not address all of the regulatory uncertainty

. associated with dose limits for design basis events, since the inconsistency between 10 CFR Part 20 and EPA regulations remains."

l NRC RESPCMSE' The Commission agrees with DOE that both the dose limits and the methodology for calculating doses to members of the public in the EPA standards differ from the dose limits and methodology for calculating doses to members of the public in Part 20, Subpart D. Notwithstanding the differences between these  ;

standards, the Commission does not consider that there is any regulatory l uncertainty regarding applicable dose limits for Category 1 design basis events. In DOE's demonstration of compliance, either the EPA standards or the Part 20 standards may be more limiting or controlling than the other, but that does not relieve DOE of the requirement to comply with both standards. As i such, the Commission has made no changes to the proposed rule to address DOE's concerns about the differences between Part 20 and the EPA standards.

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l DEFINITION OF PRECLOSURE CONTROLLED AREA "The Department is concerned that the use of the word 'immediately' in the ,

i definition of 'preclosure controlled area' could lead to an implication that  !

the boundary must be next to the geologic repository operations area. The i Department understands the concern that an unreasonably large preclosure

controlled area could be established to lower the calculated doses at the a

boundary. However, it may be entirely appropriate to fence, patrol and ,

4 control a boundary that is not coincident with the facility itself.

1 Therefore, the Department recommends that the Commission delete the word '

i 'immediately' from the definition, as follows:

Preclosure controlled area means that surface area ir :dictcly J

surrounding the geologic repository operations area for which the licensee exercises authority over its use, in accordance with the provisions of this' part, until permanent closure has been .

completed.  !

l Clarifying discussion on the ir. tended extent of the preclosure controlled area could be provided in the supplementary information that is published with the t i

final rule."

5 NRC RESPONSE NRC agrees with the recommendation to delete the word "immediately" from the definition of "preclosure controlled area." NRC is not particularly concerned i about the extent of the preclosure controlled area and believes that this L modification will provide DOE with the operational and design flexibility

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necessary to protect public health and safety.

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DEFINITION OF SITE "The definition of site should include preclosure and postclosure controlled areas. The Department recommends the following ch. age.

Site means the location of )@@l@{ sad]postclosure controlled areas."

l NRC RESPONSE i

NRC agrees that the use of the term " site" in Part 60 is broader than the definition of the term in the rule as it is used in both repository preclosure and postclosure contexts. As such, NRC agrees that the definition of " site" should be modified to reflect its meaning during the period before permanent repository closure (i.e., the operational period), as well as the period after permanent closure. t l

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4 DEPARTMENT OF ENERGY COMMENT CRITICALITY CONTROL "NRC intended to clarify the requirements pertaining to criticality control, currently in 660.131(b)(7). The present requireme..ts are contained in 560.131(b), entitled ' Structures, systems, and components important to safety.' This indicates that the requirements apply only to the preclosure time period. However, the criticality requirement contains the term '... and isolation,' which could be interpreted to imply that the requirements may be applicable to the postclosure time period as well.

NRC proposes to amend the regulation to move the former criteria ll60.131(b)(1) through 60.131(b)(10) out of 60.131(b), and to delete the heading ' Structures, systems, and components important to safety.' The rationale, according to the supplementary information, page 15185, is in part to eliminate the incongruity with the criticality control requirements.

Unfortunately, the confesion remains. The proposed 660.131(h) refers to

' isolation of radioactive waste,' a term with post closure connotations, while it notes that systems 'must be designed for criticality safety assuming occurrence of design basis events,' implying preclosure considerations.

Furthermore, the criterion in the last sentence is

... the calculated effective multiplication factor (keff) must be sufficiently below unity to show at least a 5 percent margin, after allowance for the bias in the method of calculation and the uncertainty in the experiments used to validate the method of calculation.

That criterion could be interpreted as requiring a deterministic demonstration of criticality safety over the entire period of regulatory concern, if the proposed $60.131(h) is applicable to waste isolation. The Department intends to thoroughly evaluate criticality safety throughout the period of regulatory concern in order to demonstrate compliance with the rarformance objective of 560.112. However, given the time frames involved, the Department considers probabilistic analyses to be an essential part of demonstrating long-term criticality safety. This approach is consistent with 660.101(a)(2),which notes that '... 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.' Therefore, a strictly deterministic requirement over such time periods is considered to be inappropriate.

The Department recommends the following modifications to the current rule in order to remove the inconsistencies and clarify the application of the requirements to the preclosure and postclosure time periods.

First, modify the proposed 660.131(h) as follows:

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All systems for processing, transporting, handling, storage, retrieval, je'd emplacement =d hmth; of radioactive waste shall be des @ned to ensure that a nuclear criticality accident is not possible unless at least two unlikely, independent, and concurrent or sequential changes have occurred in the conditions essential to nuclear criticality safety. Each system shall be designed for criticality safety assuming occurrence of design basis events. The calculated effect Ne multiplication factor (keff) must be sufficiently below unity to show at least a 5 percent margin, after allowance for the bias in the method of calculation and the uncertainty in the experiments used to validate the method of calculation.

This retains the current deterministic criticality safety criterion in the preclosure time frame, and it removes all references to waste isolation from 560.131(b).

Then add a new requirement 160.133(j) as follows:

Postclosure crftfealfty safety. The engineered barrier system shall be designed such that the probability and consequences of nuclear criticality provide reasonable assurance that the performance objective of $60.112 is met.

This clarifies the evaluation of the nuclear criticality requirement' for the postclosure time frame.

Alternatively, the Commission could omit the proposed new requirement 560.133(j) but consider the potential for nuclear criticality when evaluating compliance with 560.112._ In either case, the requirement in 160.131(b) should be revised as discussed above."

INtc RESPONSE The comment indicates some continued uncertainty about the intended applicability of the criticality control requirement proposed in 160.131(h).

In this regard, the proposed modifications to 660.131 were made, in part, to clarify that the criticality control requirements currently in $60.131 (b)(7) were intended to apply not only to the preclosure period but also to the 10,000-year postclosure period of interest, consistent with the reference to

" isolation of radioactive waste" in the provision. Notwithstanding this intent, NRC agrees with the commenter about the residual inconsistency in proposed 160.131(h) with reference to the statement that "each system must be designed for criticality safety assuming occurrence of design' basis events."

This statement narrowly implies that criticality safety design be based solely on consideration of " design basis events," a term that applies only to the period of operations before permanent repository closure.

Thus, while the applicability of the criticality control requirement proposed in 560.131(h) is clear with respect to preclosure considerations, uncertainty remains with respect to the applicability of these requirements to postclosure considerations. However, NRC proposes to address this remaining uncertainty 11

i in a future rulemaking to conform Part 60 with the revised EPA standards that

are currently under development, as mandated by the Energy Policy Act of 1992.

i Accordingly, NRC is not changing the requirements of 160.131(h) in this rulemaking.

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, DEPARTMENT OF ENERGY COMMENT EFFLUENT C0KfROL "Since the term 'during normal operations' was deleted from this provision, the application of the 10 CFR Part 20 effluent limii.s invoked by 660.lll(a) is i

not clear. The Department recommends that the intended application, during Category I design basis events, be specifically cited, as follows:

(c) Radiation control and monitoring- (1) Effluent control. The

! surface facilities shall be designed to. control the release of radioactive materials in effluents diFligC gj ifF$iijgii -

~M so as to meet the performanci~ob3ect@ives~$)f o '660~.T11(j$ijif~f a)T" N4C RESPONSE In the Statement of Considerations for the proposed rule (60 FR 15181), NRC notes that, "...in the administration of its regulatory program for facilities licensed under Parts 50 and 72, it has been NRC's general practice, as well as j its intent in Part 60, to apply the dose limits of Part 20 to Category 1 4

events." Notwithstanding this information, NRC believes there is merit to l DOE's recommendation to clarify the provision in 160.132(c)(1) for effluent control. Accordingly, NRC will modify the requirement as suggested by DOE. '

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DEPARTMENT OF ENERGY COMMENT ,

1 PRECLOSURE CONTROLLED AREA

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"The proposed rule speaks of an individual located on or beyond the nearest boundary of the preclosure controlled area. The u.e of the word ' nearest' is considered to be confusing and inappropriate in this context. NRC's reactor site criteria,10 CFR Part 100, uses the phrase 'an individual located at any pointonitsboundary'inasimilarcontext?fl00.110a}(1). The Department recommends that the section be revised as follows: ,

j The geologic repository operations area shall be designed so that, for Category 2 design _ basis events no individual located on or be;ond th: :::r::t controlled area ..ypj$jtjQM@g, boundary of the preclosure

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NRC RESPONSE NRC agrees with the commant and will modify the language in 660.136(b) as suggested above.

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CLEAN WATER FUM OF NORTH CAROLINA COMENT {

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! DEFINITION OF INP0RTANT TO SAFETY

" Contrary to the view recently adopted by the Commission, the Fund considers ,

that the important-to-safety definition of 10 CFR 60.2, as written, is not

' unclear with respect to the range of accidents to'be considered' (as the  !

Commission claims at 60 FR 15181). This definition rather clearly defines the t accidents that need to be considered (in the determination of whether or not a 1 structure system or component is important-to-safety), as those accidents

'that could result in a radiaticn dose to the whole body, or any organ, of ,

0.5 rem or greater at or beyond the nearest boundary of the unrestricted  ;

area.' The Fund considers this interpretation of the 10 CFR 60.2 language to '

be natural and straight-forward and cannot imagine that any other  ;

interpretation was intended. In particular, the Fund expects that the Commission ought to have no special difficulty providing a clear interpretation of the phrase ' unrestricted area,' based on its traditional prior usage of ' restricted areas' for its licensees and the existing definition in 10 CFR 60, although the Commission could (if necessary) slightly  ;

modify the rule to explain that the facility ought to be designed in such a manner that the same standard would continue to be met at the same physical boundaries, following closure." '

NRC RESPONSE j NRC disagrees with the commenter that the current definition of "important to safety" in 560.2 is clear with respect to the range of accidents to be considered in determining whether structures, systems, or components are important to safety. The term " accidents" is undefined in Part 60 and there is uncertainty about its meaning with respect to the range of events the term encompasses. The full range of Category 1 design basis events would not generally be considered as " accidents," especially those events occurring regularly or moderately frequently. However, certain lower frequency Category 1 events, which occur one or more times-during the operating lifetime of a facility and are otherwise known as " anticipated operational occurrences," have at times been identified as " accidents." But " anticipated operational occurrences" are conditions of normal operation that are not to be confused with the unlikely, but credible and potentially significant Category 2 design basis events. As such, the current definition of "important to safety" is unclear with respect to its intended applicability to the design of structures, systems, or components for normal operations, including anticipated operational occurrences. Further, with the focus on protection of members of the public in unrestricted areas, the current definition of "important to safety" does not explicitly address protection for the occupational work force. The uncertainty, in this regard, is not related to interpreting the meaning of " unrestricted area," but, rather, is related to the narrow focus of public exposure in unrestricted areas. Lastly, the value of 0.005 Sv (0.5 rem) as a dose limit in unrestricted areas for " accident" conditions lacks consistency with a corresponding limit in Part 72 and with  !

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dose values established as guidance for selected accidents (fuel handling and cask drop events) at Part 50 facilities (commercial power reactors).

As noted by NRC in the Statement of Considerations for the proposed rule (60 FR 15181), these uncertainties raise questions about the adequacy of the requirements in the rule to protect public and worker health and safety for ,

the full range of conditions or events that may occur before repository closure. To address these issues, the proposed modifications to the definition of "important to safety" would provide numerical criteria for each of two categories of design basis events (i.e., Category 1 and Category 2).

These modifications would ensure that the definition would apply to the full range of conditions or events that may occur before repository closure (i.e., the events embodied by the description of both Category 1 and Category 2 design basis events in the proposed rule). The numerical criteria referenced in the proposed definition not only aid in the identification of those structures, systems, and components important to safety, but also provide for internal consistency with respect to the technical criteria of  ;

Subpart E of Part 60. Specifically, structures, systems, and components  !

important to safety would be those necessary to satisfy the requirements of i f60.lll(a) for Category 1 design basis events and 560.136 for Category 2  !

design basis events. Lastly, the modifications would ensure that both public and worker health and safety are considered in the development of the design of repository structures, systems, and components important to safety. With these considerations in mind, the modifications to the definition of "important to safety," in concert with other proposed changes to Part 60, both  !

enhance and ensure the adequacy of the requirements in the rule to protect public and worker health and safety.

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CLEAN WATER FUND OF NORTH CAROLINA CONNENT l 3

i IRIMERICAL RADIATION PROTECTION STANDARDS l "The 0.5 rem limit, which the Commission claims is suggested by the existing 10 CFR 60.2 language, is not overly protective of public health and safety; there is therefore no reason to seek a weaker standard. Moreover, 10 CFR 60 establishes explicit limits in 60.111, 60.131, and 60.132; Part 60.111 limits '

releases to unrestricted areas to comply with the limits given in 10 CFR 20, the natural interpretation of which would include the public limits of ,

10 CFR 20.1301 (0.1 rem annually, including public in the controlled areas t with an option for a 0.5 rem license subject to ALARA conditions), Part 60.131  !

limits air releases in the restricted areas to comply with the occupational i limits given in 10 CFR 20, presumably 10 CFR 20.1201 (which are essentially l the limits which the Commission now proposes to extend, from facility workers, j to the public at 100 meters from the boundary of the controlled area); while  !

Part 60.132 requires surface facility design to meet the limits referenced in Part 60.111. If the Commission desired simply to remove any ambiguity from its regulations, it could just add an explicit reference to 10 CFR 20.1301 to the language _in Part 60.111; and if the Commission (further) wished to protect the public health and safety, as claimed at 60 FR 15180, then the Commission could remove the 0.5 rem license option from Part 20.1301 and could also substantially reduce the 0.1 rem exposure limit therein. However, the Commission does not seem by this portion of the proposed rule better to protect the public health and safety: the proposal as written rather relaxes standards which otherwise might potentially protect individuals following those 'unlikely but sufficiently credible' (or ' category 2 design basis')

events, which the Commission seems to claim will not occur more than once during the operational period (supposing the given ' upper bound' probability of IE-2 and the century of facility operation life given at 60 FR 15186)."

NRC RESPONSE The Commission acknowledges that the 0.005 Sv (0.5 rem) dose limit in the definition of "important to safety" in the existing rule could be construed to be an implicit basis for designing structures, systems, and components to prevent or mitigate the consequences of accidents at the boundary of the unrestricted area. On the other hand, the 0.005 Sv (0.5 rem) dose limit could also be interpreted more narrowly, to identify only those structures, systems, and components that are subject to additional design requirements and a quality assurance program to ensure performance of intended functions. See 10 CFR 60.131(b) and 60.151. In short, the 0.005 Sv (0.5 rem) dose limit in the definition of "important to safety" in the existing rule is, in the  ;

Commission's view, subject to conflicting interpretations.

As previously. discussed, the Commission's comprehensive review of 10 CFR Part 60 identified deficiencies in both the clarity and sufficiency of requirements to protect workers and public health and safety. Among the identified deficiencies is the regulatory uncertainty created by possible conflicting ,

interpretations that could be given to the 0.005 Sv (0.5 rem) dose limit in )

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the "important to safety" definition described above, and by the absence of an explicit design basis dose limit in Subpart E of the existing rule. An objective.of this rulemaking is therefore to resolve the uncertainty in Part 60, as well as remedy the incomplete definition of "important to safety" that fails to address protection of both workers and members of the public during Category 1 design basis events (i.e., normal conditions, including l anticipated operational occurrences). The Commission has addressed these ,

defu.fencies with the addition of new $60.136, which now provides explicit j design basis accident dose criteria for repository structures, systems, and '

components, and modification of the definition of "important to safety" to include the broader interests of both worker and public health and safety for l the full range of conditions or events that may occur before repository l closure. The Commission believes that these amendments, as well as the others as described herein, clarify and enhance the provisions in the rule to protect I worker and public health and safety.

I It was not the intent of this rulemaking to modify, in any way, the Commission's numerical radiation protection standards. As noted in the Statement of Considerations (60 FR 15181), NRC's numerical radiation protection standards are codified in Part 20 and apply to operations at a geologic repository by virtue of 10 CFR 20.1002 and 10 CFR 60.111(a). The I Commission believes that these standards continue to be appropriate for its licensees and provide adequate protection of worker and public health and safety at a repository. NRC further notes its intent that these standards be observed not only during normal operating conditions (i.e., during Category 1 design basis events) but also, to the extent practicable, during emergencies (i.e., during Category 2 design basis events). As such, the proposed amendments to Part 60 do not relax the standards for protection of public health and safety or, otherwise, create a weaker standard.

The comments about possible modifications to Part 20 in this regard are beyond the scope of this rulemaking.

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VERNON J. BRECHIN COMMENT DEFINITION OF CONTROLLED AREA "On line 13 of the Summary (p. 15180) the statement was made that '... the establishment of a preclosure controlled :ccea from which members of the public can be excluded.' The word 'will' should have been used instead of the word

'can' since the intent of the ' Defense-in-depth' plan involves exclusion of members of the public.

"According to the definition of Controlled Area (10 CFR part 60.2), this area could encompass up to 102 square miles of surrounding surface area in the case  !

of the proposed Yucca Mountain facility. According to the section that  ;

describes the Land Ownership and Control (10 CFR part 60.121) the DOE would be granted comprehensive controls over the area within the Controlled area boundary and according to subpart (b) ' Appropriate controls shall be established outside of the controlled area. DOE shall exercise any I jurisdiction and control over surface and subsurface estates ...'"

NRC RESPONSE:

The come nt sppears to result from confusion regarding the terms " controlled ,

area" as defined in existing Part 60, " controlled area" as defined in Part 20, and "preclosure controlled area" and "postclosure controlled area" as defined in the proposed revisions to Part 60. It is not NRC's intention to generally exclude members of the public from the preclosure controlled area (which would be the " controlled area" as defined in 620.1003). However, access to the  ;

preclosure controlled area can be limited by the licensee for any reason (not l necessarily one related to radiation protection). Within the preclosure <

controlled area will be a " restricted area" (as defined in 660.2 and 520.1003), access to which must be controlled for purposes of radiation I protection. Members of the public in the preclosure controlled area will be subject to the dose limits for members of the public in 620.1301, but an individual who receives occupational dose in the preclosure controlled area will be subject to the occupational dose limits of Subpart C of Part 20. All doses in a restricted area are occupational doses. This approach is consistent with that taken throughout NRC's licensing activities. The size of the preclosure controlled area is not specified by the regulations because it will be dependent upon the particular activities to be conducted during the operational period.

The comment also suggests that the rule may be inadequate regarding the reference to exclusion of members of the public from the preclosure controlled area ("can be excluded" instead of "will be excluded"). The rule, however, calls for the Department of Energy (DOE) to demonstrate that "...the requirements of $60.136 will be met." The measures proposed by DOE, if found acceptable, would be reflected in the license that is granted.

i 4 Section 660,121(b), mentioned by the commenter, deals with postclosure i isolation, and not with the period of operations. '

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

4 VERNON J. BRECHIN COMMENT BALANCE OF COMENTS "The DOE and its predecessor agencies have over a half century of experience in excluding members of the public from many of its vast facilities which, it has always claimed, were operated in a ' safe' manner. As a result of the agency's self regulation, future generations will be asked to fork out many hundreds of billions of dollars to cleanup the DOE facilities (D0E/EM-0232).

The Nuclear Regulatory Commission (NRC) was formed because of the recognition of the Atomic Energy Agency's (AEC's) problems arising from its mandate to both promote and regulate itself. A large portion of the AEC's operations were not subject to NRC controls and, as a result, future generations will be paying an extremely heavy price. The NRC should not be reneging on its mandate to regulate its parent agency. The price, of the DOE's contamination of vast stretches of withdrawn public lands, should not be the granting, to the DOE, of permanent control over these lands and over additional withdrawn buffer zones.

I suggest that you ask your legal advisors to take a closer look at the CFR  ;

provisions that grant, to th'e DOE, administrative control over the sizeable controlled area and its surrounding area. They should ask whether the i controls are reasonable, excessive, or poorly defined? This analysis should .

include the 100 year preclosure and the 100 year postclosure period during l which institutional controls are assumed to be in effect. The reviewer should ask, what has been the historical track-record on the closure of other DOE facilities? Does the exclusion of members of the public serve to protect the health and safety of the public as claimed or does this exclusion protect the DOE's operations from the prying eyes of the public that the DOE is supposedly serving?"

NRC RESPONSE:

Regarding the definitions and interpretation of " controlled area," see the response to the comment entitled Definition of Controlled Area (Vernon J.

Brechin). The remaining remarks, regarding public oversight of the DOE, the public's costs of cleaning potential contamination, and crcdibility of NRC and DOE activities, do not relate to the substance or content of this rulemaking.

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f U.S. ENVIRONNENTAL PROTECTION AGENCY COMENT i

NO COMENTS i "In accordance with the National Environmental Policy Act (NEPA) (42 U.S.C. l 4321 et. sea.) and Section 309 of the Clean Air Act, the Environmental '

Protection Agency (EPA) has reviewed the Nuclear Regulatory Comission's Proposed rule on 10 CFR Part 60 disposal of high-level radioactive wastes in '

geologic repositories / design basis events and has no comments." i l

NRC RESPONSE:

l No comment.

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A NVE COUNTY, NEVADA, NUCLEAR WASTE REPOSITORY PROJECT OFFICE CONNENTS SUPPORT FOR THE PROPOSED RULE "We have carefully reviewed the proposed amendments and support their adoption by the Commission. We especially favor the proposed amendments' modificati6n of the term 'important tu safety' to ensure that it applies to protect workers and the public from exposures resulting from events that will occur regularly, moderately frequently, or one or more times during preclosure operations at the geologic repository operations area (Category I events).

We also strongly support the harmonization of 10 CFR 60 with the Commission's counterpart regulations in Parts 20 and 72. We agree that this brings needed consistency to the regulatory framework applying to the repository program, without s.crificing worker or public health and safety, which must, of course, remain the paramount concern of the program."

NRC RESPONSE:

No comment.

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VIRGINIA POWER COMMENT 1

DEFINITION 0F DESIGN BASIS EVENTS "The proposed rule defines Category 1 design basis events to be 'those natural

.nd human-induced events that are reasonably likely to occur regularly, moderately frequently, or one or more times before permanent closure of the 3

geologic repository operations area. ' We agree with this definition.

However, the rule should make it clear that the normal operations associated with receiving, handling, packaging, storing, emplacing, and retrieving high-level waste are agi design basis events. The proposed rule blurs this distinction as discussed below."

NRC RESPONSE:

a It is NRC's intent that events occurring regularly or frequently during the

course of normal operations Arg considered as Category 1 design basis events.

Specifically, when identifying items "important to safety," if-it is

determined that a particular structure, system, or component is essential to maintaining doses below Part 20 limits during normal operations (or during any Category I design basis event), then that structure, system, or component must i be designated as "important to safety." The list of structures, systems, and components "important to safety," as well as the list of engineered barriers "important to waste isolation," are collectively referred to as the "Q-list" and are subject to the quality assurance (QA) provisions of Part 60, Subpart G.

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DEFINITION 0F INP0RTANT TO SAFETY  ;

"The proposed rule defines important to safety. The definition in part refers to '...(1) to provide reasonable assurance that high-level waste can be 1 received, handled, packaged, stored, emplaced, and retrieved without exceeding i the requirements of [10 CFR] 60.111(a) for category 1 design basis events; j or...' This part of the definition should be revised to make it clear that the focus of 'important to safety' is design basis events, and ad the normal J operations that are described by the definition in the proposed rule. The.

effect of this portion of the proposed definition would be to apply full Quality Assurance requirements to almost every system and craponent of the 3 repository. The proposed change does not establish a gradec Quality Assurance 2

system to properly distinguish systems that are 'importan? to safety' and i ensure that the full Quality Assurance program is only applied to those '

. systems. Defining every system that controls doses as 'important to safety'

! would increase the costs of the repository unnecessarily and without a commensurate increase in safety. ,

j The definition also establishes the 10 CFR Part 20 limits that are referenced  :

in [10 CFR] 60.lll(a) as 1.he acceptance criteria for the Category 1 design i basis events. This seems to be inappropriate. 10 CFR Part 20 establishes '

j occupational dose limits and radiation dose limits for. members of the public.

j The [10 CFR] Part 20 liraits are expressed as annual limits, and are associated  ;

with normal licensed ar,tivities - not aesign basis events. It is not ,

appropriate to use [10 CFR] Part 20 ilmits to evaluate specific events. l 1 Typically, acceptance criteria for .fesign basis events are associated with the '

i specific consequences of'those eveats, as for exarple in section [10 CFR] l i 60,136 for the Category 2 desiga basis events. Appropriate acceptance l

criteria will need to be developed if Category 1 design basis events are  !

j retained by the final rule." i

! NRC RESPONSE:

NRC supports a graded approach to meeting the QA provisions of Part 60. Such

an approach is consistent with NRC's " Technical Position on Items and j Activities in the High-Level Waste Geologic Repository Program Subject to Quality Assurance Requirements (NUREG-1318)." The guidance given in that

! technical position (TP) is still applicable under the proposed rule changes.

The TP describes a graded application of QA measures consistent with that i j applied to other facilities (e.g., nuclear power reactors) licensed by NRC. '

l In this regard, the application of QA program requirements to repository i

! structures, systems, and components would generally be commensurate with their

j. importance to safety.  ;

l NRC disagrees with the comenter that Part 20 limits are inappropriate. The ,

numerical radiation protection standards are codified in Part 20 and apply to l

} operations at a geologic repository by virtue of f20.1002 and f60.lll(a). 1 i However, it is not the Commission's intent that it is necessary to use the l 24 ,

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annual limits in Part 20 to evaluate specific Category I design basis events on an individual basis. Instead the Commission intends that the lum of the annual doses, exposures, and releases from All Category 1 design basis events shall not exceed the limits specified in Part 20 and in the EPA standard.

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f NUCLEAR ENERGY INSTITUTE CONNENT l

RANGE OF PROBASILITIES FOR CATEGORY 2 DESIGN BASIS EVENTS "In the Supplementary Information, NRC states, '[w]ith respect to the range of i probabilities of Category 2 design basis4 events...the lower bound is considered to be on the order of I x 10 pergear(i.e.,eventscenarioswith probabilities of occurrence less than 1 x 10 per year would generally be  ;

screened from further consideration due to their negligible contribution to  ;

overall risk).' This proposed screening criterion appears too low by several  ;

orders of magnitude compared with previous NRC policy and practice. For  !

example, NRC's ' Safety Goals for Operations of Nuclear Power Plants' provides ,

guidance that '...the overall mean frequency of a large release of radioactive i materials to the environment from a reactor accident should be less than 1 in l 1,000,000 per year of reactor operation.' Generic Letter 88-20, ' Individual Plant Examination [IPE] for Severe Accident Vulnerabilities,' provides '

criteriafordeterminingpotentiallyimportantfunctio9alsequencesand  ;

functional failures that range from 1 x 10.to 1 x 10' per reactor year. i We recommend that the discussion in the Supplementary Information, be modified i with regard to the range of probabilities of design basis events to be considered in the license applicat on the range of I x 10 to 1 x 10'}on.

beWe suggest employed, that a consistent which.is screeningwith criterion NRC policy and practice in other areas of regulation. Also, this criterion should ultimately be reflected in the appropriate regulatory guidance supporting the final rule."

NRC RESPONSE:

NRC agrees with this comment. See the response to the comment made by the U.S. Department of Energy, entitled fr9h3bility bounds for Cateaorv 2 desian basis events.

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NUCLEAR ENERGY INSTITUTE COMMENT DEFINITIONS OF DESIGN BASIS EVENTS AND IMPORTANT TO SAFETY "The definition of 'important to safety' refers to '...those features of the repository whose function is to provide rc::onable assurance that high-level waste can be received, handled, packaged, stored, emplaced, and retrieved with6ut exceeding the requirements of 660.111(a) for Category 1 design basis events...' ' Design basis events' are defined as '...those natural and man-induced events that are reasonably likely to occur regularly, moderately, frequently, or one or more times before permanent closure of the geologic repository operations are...' Section 160.111(a) includes the criterion that

'the geologic repository shall be designed so that until permanent closure has been completed, radiation exposures and radiation levels, and releases of radioactive materials to unrestricted areas, will be maintained within the limits specified in Part 20...and such generally applicable environmental standards for radioactivity as may have been established by the Environmental Protection Agency.

The wording in the proposed rule may be taken to infer that routine operations at the repository are to be considered ' design basis events' We do not believe this is intended by the proposed rule. If this were the case, then the proposed rule would potentially have the effect of fully applying quality assurance requirements to a substantial portion of the repository structures, systems and equipment without proper consideration of their associated safety significance with regard to preventing or mitigating accidents. We do not agree with such an approach because it would not support a graded approach to quality assurance commensurate with significance to protection of health and safety, leading to disproportionate cost and resource burdens. We recommend that the wording on the definition of ' design basis events' be changed to clarify that routine operations are not ' design basis events.'"

i NRC RESPONSE:

See the response to the comments made by Virginia Power, entitled Definition of Desian Basis Events and Definition of Imoortant to Safety.

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4 ENVIRONMENTAL COALITION ON NUCLEAR PWER CONMENT LEVEL OF RISK ACCEPTABLE TO PUBLIC "We note, first, in the Staff's discussion of the Existing Rule, Part 60 (at

p. 15180), the reference to risks in terms of 'the bounds of risks accepted in other productive activities in society.' This language sets a parameter that is inappropriate to the kind of activity that is being regulated: namely,

' waste disposal.' We would argue that ' waste' is, by its very definition, that from which society (or, in this instance, the societal subset composed of NRC's licensees that have generated the materials that they have designated as

' waste') has decided it can derive no further productive value. Although the ,

matter is raised in the context of defense-in-depth during the preclosure period, the adoption of a standard in this context may be subsequently applied to the postclosure period as well. This moves NRC regulation away from the j societal responsibility for future generations and future environmental quality that the Atomic Energy Act, Nuclear Waste Policy Act, and the National Environmental Policy Act mandate. Any weakening of repository siting and design criteria allowed in this risk context for the preclosure period will

almost inevitably also weaken long-term containment capability of the

high-level waste repository."

NRC RESPONSE:

. The disposal of radioactive waste is a necessary component of the nuclear fuel cycle. Because the Atomic Energy Act of 1954 (42 USC sec. 2011) mandates a j national policy te pursue development of the peaceful uses of atomic energy, J NRC considers the development of a repository for high-level radioactive waste l as being a productive activity for society in general.

The changes proposed in this rulemaking activity affect the operational period for the GROA. Only non-substantive changes and clarifications have been made to postclosure provisions. These changes should not be construed to alter the existing postclosure performance objectives, design criteria, siting criteria, i

land ownership requirements, performance confirmation requirements, or any 4

other postclosure requirements, in any way. As noted in the response to the

comment made by Clean Water Fund of North Carolina, entitled " Definition of l Important to Safety," NRC disagrees that the modifications to Part 60 create a weaker standard.

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ENVIRONNENTAL COALITION ON NUCLEAR POWER CONNENT CLARITY AM CONSISTENCY l

j "In the same section (The Existing Rule, p.15180), Staff enumerates concerns about the clarity, sufficiency, and consistency of provisions of Part 60. ,

Here, too, the temptation is surely present, in this era of deregulation in i the guise of regulatory reform, to redefine or realign in ways that lessen, >

rather than enhance, ultimate waste isolation. Such result the Commission l must not permit." l NRC RESPONSE:

See the response to the comments by the Clean Water Fund of North Carolina entitled " Definitions of Important to Safety" and " Numerical Protection Standards." The proposed changes focus only on the operational period before l repository closure, not on postclosure waste isolation.

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ENVIRONNENTAL C0ALITION ON NUCLEAR POWER CONNENT PCRFORMANCE OBJECTIVE FOR RADIATION PROTECTION "In the section 'Important-to-Safety' Definition (at p. 15180-1), we support

inclusion of consideration of the full range of events, accidents or other

operational events, that may cause members of the public offsite to receive a radiation exposure. That limit of exposure, however, should be no higher than the most restrictive exposure limit that the EPA (the Federal standards-4 setting body) imposes for any licensee or other source of regulated nuclear activity. If EPA imposes a 15 mrem /yr effective dose equivalent limit from a low-level waste facility, or a 4 mrem /yr drinking water standard, then that is what NRC should recognize for HLW. A 500 mrem (5mSV) is no longer permissible under 10 CFR Part 20 for an operating nuclear facility, absent special NRC dispensation; it should be impermissible for an individual dose from a waste site, as well, whether or not an accident has taken place. The most stringent level of worker protection, better than Part 20, should also be required."

NRC RESPONSE:

The provisions of Part 20 and applicable standards established by EPA provide adequate radiation protection for workers and members of the public for Category 1 design basis events. Protection for members of the public during Category 2 design basis events is discussed in the comment entitled, " Design Bases for Category 2 Design Basis Events (Environmental Coalition on Nuclear Power)." Worker protection for Category 2 design basis events is discussed in response to the comment entitled, " Accident Related Worker Doses" (Environmental Coalition on Nuclear Power).

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, ENVIR0 MENTAL C0ALITION ON NUCLEAR POWER CONNENT i

l PERFORMANCE OBJECTIVE FOR RADIATION PROTECTION l "In the section Performance Objective for Radiation Protection (p. 15181), we

! support application of the most restrictive Part 20 or EPA standards, or even j more so, with respect to all waste-related activities and at all times, l

including retrieval, before or after closure, t

! As for probable, credible, unlikely, and incredible accident event categories, ECNP reminds the Staff that, in the 1977 Three Mile Island Unit 2 operating i

license proceedings in which ECNP was an Intervenor two decades ago, Staff and Applicant witnesses confidently assured the ASLB that even a Class 9 accident 4

scenario was so highly improbable an event that it need not be considered; yet a Class 9 accident did in fact occur within three months of the start of commercial operation of TMI-2. The most improbable sequences and combinations of events and accidents (Category 2 and beyond) most certainly must be evaluated, recognized, and designed for prevention in standards-setting.

Moreover, the NRC's historical approach to accident analysis has avoided taking into account the entire set of combinations and permutations of component failures and failure modes that may characterize actual accidents in a complex nuclear facility. All are important to safety; all should be so considered by the Commission. Truly consistent quality assurance would take all aspects of a facility into account in determining safety."

NRC RESPONSE:

Section 60.111 applies only to operations at the geologic repository operations area before permanent closure. Separate performance objectives apply during the postclosure period (i.e., 560.112 and 660.113). Application of 160.111 to postclosure is therefore inappropriate. The reasons for deleting the phrase "at all times" are discussed in the response to the comment entitled, " Accident Related Worker Doses" (Environmental Coalition on Nuclear Power).

NRC intends to develop detailed guidance which will describe how the staff will review DOE's analyses of design basis events. Some clarification of the types of events to be considered and the frequencies of these event is provided in the responses to the comments by 00E. For a discussion of the approach to QA, see the response to the comment entitled Definition of Imoortant to Safety (Virginia Power).

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i ENVIR0 MENTAL C0ALITION ON NUCLEAR POWER CONNENT DESIGN BASES FOR CATEGORY 2 DESIGN BASIS EVENTS "In the section on 10 CFR Part 72 (p.15182), no limits should be placed on the definition of 'important to safety' as it has been NRC's practice to do. .

i By using an ' undue risk' criterion, the Commission is in essence saying that

those who are at risk, and most at risk, may be sacrificed on some altar of t NRC definition of what it believes'to be ' undue.' In our opinion, Part 20 i standards are not restrictive enough for the purpose of public health

protection with respect to the storage and .' disposal' of radioactive waste, .

i especially intensely radioactive wastes. A 5 rem (0.05 Sv) whole body dose to a member of the public from a design basis accident (dba) is unconscionable."

NRC RESPONSE:

The reference to " undue risk" reflects the several references in the Atomic Energy Act to Commission authority to assure that licensed activities will not  ;

constitute "an unreasonable risk" to the health and safety of the public. The '

regulations of NRC, in particular, those that define "important to safety,"

are designed to indicate more clearly how such " unreasonable risk" is to be i measured. As the present rulemaking is concerned with the period of l operations, standards for postclosure disposal are not germane. The 5 rem

(.05 Sv) design basis applies only to Category 2 design basis events, and .

includes consideration of the low-frequency nature of these events. In view of the reasons set out in the notice of proposed rulemaking, NRC disagrees '

with the commenter's characterization of this potential dose as being "unreasonabl e. "

The appropriateness of Part 20 standards to protect worker and public health and safety at a repository is discussed in the response to the comment made by the Clean Water Fund of North Carolina, entitled Numerical Radiation Protection Standards.  !

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il l ENVIRONMENTAL C0ALITION ON NUCLEAR POWER COMMENT i

ACCIDENT RELATED WORKER DOSES

,_ "In any and all of the ways that the DOE Proposed Rulemaking Petition (PRM-60-3, 55 FR 28771) weakens or lessens criteria, limits, or definitions now required in NRC's regulations, the petition should be rejected. Without question the Part 60 phrase 'at all times' must be retained for all accident, incident, or event categories, not deleted as NRC plans to do.

"As for Category 2 accident-related worker doses, the NRC's justification for not providing them is without merit and should be reversed to assure that workers will not receive high doses in the course of rare but severe accident j events." i 5

NRC RESPONSE:

The phrase "at all times," was-originally included in the regulation to emphasize the need to design the GROA such that retrieval activities, if found necessary, would be conducted in accordance with Part 20. NRC continues to interpret the regulation in this manner but has removed the phrase "at all

times" from f60.111 in the proposed rulemaking, to clarify that the separate i

design bases of f60.136 apply for Category 2 design basis events. Further, '

l NRC recognizes that conformance to the regulations should not hinder any 4

actions that are necessary to protect public health and safety, such as lifesaving or maintaining confinement of radioactive materials (56 FR 23365).

The phrase "at all times" is ambiguous in this respect and was, therefore, removed.

NRC considers that the additional design considerations afforded to important to safety components, as well as the licensee's training, emergency planning,

' and radiation protection programs, will each contribute to providing  ;

protection to workers during Category 2 events.

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ENVIRONMENTAL C0ALITION ON NUCLEAR POWER COMMENT DEFINITION OF IMPORTANT TO WASTE ISOLATION "Although the Staff plans to address a definition of 'important to waste isolation' in a separate rulemaking, we urge that this issue also be addressed in this rule, because long-term health and safety and environnental protection are only as good as the containment in isolation of the waste. This is, in fact, at the very core of the issue."

NRC RESPONSE:

NRC agrees in principle with the commenter that a definition for the term "important to waste isolation" should be addressed for the purpose of identifying necessary QA requirements for those natural and engineered features which are relied on to meet the postclosure performance objectives of a repository. However, the amendments to Part 60 proposed by this rulemaking action are directed at clarifying the terms and requirements necessary to protect public health and safety prior to permanent closure of the facility.

Because of this, NRC has deferred promulgation of an "important to waste isolation" definition for a subsequent rulemaking.

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ENVIRONMENTAL COALITION ON NUCLEAR POWER COMMENT DEFINITION OF IMPORTANT TO SAFETY "In the Section-by-Section Analysis (p. 15184-7), at Section 60.2, Definitions, the changes in ' controlled area' to recognize a distinction between pre- and post-closure seem to be reasonable, so long as a means of continuous and continued monitoring and control of this restricted area is provided for in regulation for the long-term.

"However, the definitional alteration of the term 'important to safety' is not adequate to assure health protection for the public. This is because the proposed Category I and 2 numerical limits for exposures are based on standards that have failed to take into account tha noncancer but adverse health effects of chronic low-dose radiation exposures that have been reported in the literature since development of NRC's Part 20 revision and on which ECNP has previously commented to NRC, EPA, DOE, and Pennsylvania's Department of Environmental Resource.

In particular, we call the Staff's attention to research findings on chronic low-dose impacts on children that have been l reported by radiation biologists and physicians from the former Soviet Union.

It is especially important, for long-term protection that we are obliged to provide for future populations, that extremely conservative radiation protection criteria. standards be utilized in repository design and performa more restrictive than NRC proposes.

"It is wrong to liken design basis for a waste repository (or long-term storage) facility to design basis for an operating nuclear reactor orofother contemporary nuclear facility. This is so because of the longevity the The low-dose  :

hazard and uncertainties of future monitoring and control.

effects constitute a real issue, both for those who suffer the chronic low-dose effects that include immunodysfunctions and for the society that must pay the health care costs and lost economic productivity of those whose health is undermined by such damage, or by such damage in conjunction with the injuries caused by other contaminants in the environment to which an individual may also be exposed."

NRC RESPONSE:

Administrative controls (such as continued and continuous monitoring of the restricted area) following permanent closure are beyond the scope of this rulemaking.

The numerical limits and design bases in the proposed rule are based uponThis NRC's current methodology for evaluating consequences of a given dose.

methodology results in the standards in Part 20, and is based upon recommendations given by the International Commission on Radiation Protection (i.e., ICRP 26). The adequacy of the methodology in light of revised risk estimates, due to new studies on radiation effects, is beyond the scope of the 35

proposed rulemaking. Any future reductions in the dose limits by NRC would be the subject of a future rulemaking proceeding.

The design bases provided in the proposed rule are for operations at the GROA and not for postclosure performance. Because operations at the repository are ,

expected to be similar to operations at other facilities licensed by NRC  !

i (e.g., Part 72 facilities), NRC believes that it is appropriate that their design bases be comparable. ,

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. l ENVIR0 MENTAL COALITION ON NUCLEAR POWER COMENT CONTENT OF APPLICATION "In Section 60.21. Content of Application (p. 15184), the Commission should require DOE to provide dba analyses for more than undefined ' critical design basis events, singly' and should require demonstration that doses would be kept far below the maximum permissible dose limits, with an ALARA requirement l at least comparable with that for operating reactors. Since these are waste facilities for ' disposal' and storage, the limits must be much more stringent than for operating nuclear facilities. We repeat that Part 20 is already l outdated and inadequate, particularly for long-term waste isolation.

"The terms ' normal conditions,' ' anticipated operational occurrences,' and

' accidents' are not equivalent to nor adequately described by the term ' design basis events.' This language belonged to the old outmoded 'nukespeak' that has for so many years been a discredit to the agency.

"At Section 60.111 and throughout, the phrase 'at all times' should be retained.

"At Section 60.130 Scope of Design Criteria, just as ALARA is used to require an NRC licensee to hold exposure levels to some level well below the maximum permissible dose, so here DOE as waste repository license applicant should be i held to the converse of ALARA with respect to meeting ' minimum criteria for l design.'

"That is to say, an AHARA principle should be adopted by the NRC to require licensees to demonstrate that they are meeting an As High As Reasonably Achievable design standard. The purpose is to provide an extra measure of conservatism. For an operating nuclear facility, regulatory changes over time that mandate tighter standards and reduced emissions can be accommodated by means of backfitting; this is not so readily accomplished at a ' disposal' facility, if indeed it is even technically possible after waste entombment.

These reconnendations are applicable also to Section 60.131 General Design Criteria (p. 15185)."

NRC RESPONSE:

See the response to the comment by DOE entitled Multiole failure scenarios.

As operations at a GROA are expected to be similar to those at other licensed facilities (e.g., Part 72 facilities), NRC believes that it is appropriate that their design bases be comparable. The systematic process of identifying those structures, systems, and components which are "important to safety," and applying QA criteria to them, is used to help provide reasonable assu.ance that the requirements of Part 60 are met.

Notwithstanding the comments offered by ECNP, the Commission considers that the definition of " design basis events" in the proposed rule does adequately define that term, and that the supplementary information in the proposed rule 37

L does adequately describe the relationship between the terms " normal conditions," " anticipated operational occurrences," " accidents," and " design basis events." In this regard, it was the Commission's intent to supplant undefined terms in the rule (i.e., " normal conditions," " anticipated operational occurrences," and " accidents") with a defined term (i.e., " design basis events").

The reasons for deleting the phrase "at all times" are discussed in the response to the comment entitled Accident related worker doses. As this l rulemaking does not address postclosure performance, the concerns with respect i to emissions after disposal are not pertinent.

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APPROPRIATENESS OF 5 REN (.05 Sv) D0SE LINIT i

"In Section 60.136 Preclosure Controlled Area (at p. 15185), NRC would adopt

DOE suggestions, allowing a 5 rem dose to a member of the public. We support

recognition of the ingestion and inhalation pathways but object to the high

TEDE dose limit that NRC would allow. The argument can and should be advanced

! that, especially for radioactive waste isolation, the regulatory maxim that, j for the health risk from every dose received from a licensed activity, there i should be an equal or greater benefit to the recipient. The NRC should not only adopt this principle but should act upon it by setting far more

restrictive exposure limits for all radioactive wastes. The NRC's 50 res  !

organ and tissue dose limit is far too lenient, and is the 15 rem dose to the  ;

j eye lens. NRC goes on to admit that this latter limi', will ' ensure that no '

, observable effects... will occur.'

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"We urge NRC to adopt a zero release design goal, comparable with that l

required in law by the Commonwealth of Pennsylvania for a LLRW facility, and j to enforce it. The lack of specificity is exemplified in the example accident  !

j sequence (p.15186) where NRC allows ' partitioning of (some undefined] l i fraction of the radionuclide inventory.' Use of fatal cancer death risk '

] comparisons with other toxic materials to justify the Commission's action is specious and is truly arbitrary, capricious and contrary to the Commission's  ;

! statutory obligations to protect public health and safety and the quality of  !

j. the environment. ,

"The arguments offered by the Commission to justify its conclusion that

impacts on members of the public from a repository accident would be 'somewhat limited' are wholly without foundation. Them and the conclusions and

! regulatory policies and actions that follow from them should be rejected, i Only in passing does the Commission even admit that waste disposal

technologies have not been tested for their durability in the real world. The i entire risk assessment is a very shaky house of insubstantial cards and should i be abandoned by NRC in favor of the most restrictive strict standards,

! criteria, and other regulatory requirements that the Commission can devise.

!' We're not considering a 30-year or 40-year operation; we are looking at supposedly permanent ' disposal.' One of the first things the Staff should do j is abandon the term ' disposal' and ban it from their thinking. They are not

! ' disposing of spent fuel or of HLW; they are merely changing its location and j' perhaps its form. It will still be there, and for fearfully long periods of

time. This entire FR Notice of Rulemaking should be predicted on this

! understanding and on the real goal of devising the best possible system for preventing and at the least minimizing radiation exposures from all forms of radioactive materials and wastes for both the present population and future generations, and doing so in ways that will allow the latter to have an opportunity equal to ours to continue to be able to maintain control in j isolation over all radioactive wastes."

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. NRC RESPONSE: i 1

5 The proposed 160.136 describes design criteria for Category 2 design basis  !

events and not acceptable dose criteria for accidents. The primary utility of l the 5 rem (.05 Sv) total effective dose equivalent (TEDE) design basis is to  !

identify systems important to safety and design them against Category 2 design  !

4 basis events. The proposed 5 rem (.05 Sv) TEDE design criteria, as well as j

! the associated 50 rem skin dose limit, the 50 rem organ and tissue dose limit, 2

and the 15 rem eye lens limit, are at levels that: (1) protect public health <

4 and safety considering that the risk associated with Category 2 design basis events is low (i.e., as noted in the Section-by-Section Analysis of the draft i final rule (Attachment 1, potential higher consequence events would be

, expected to have correspo)ndingly lower probabilities of occurrence); (2) are j consistent with corresponding criteria in Part 72 for monitored retrieval l l storage installations and independent spent fuel storage installations; and 1 (3) are consistent with guidelines established for both fuel handling l accidents and spent fuel cask drop accidents at nuclear power plants.

Absolute safety or "zero risk" is not legally required. The Atomic Energy Act j (PL 83-703) refers to protection against " unreasonable risk" rather than  ;

" absolute" protection of the public health and safety. A "zero release goal," '

as suggested in the comment, is therefore viewed as unwarranted for either the l operational or postclosure phases of the geologic repository. Such a goal is also viewed as impractical and difficult to implement.

As for the remainder of the comment, as previously stated, this rulemaking action concerns the operational period of the repository and not the I

postclosure period.

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- ENVIR0 MENTAL C0ALITION ON NUCLEAR POWER COMENT 5 REN DOSE LINIT AS A DESIGN BASIS FOR PROTECTING PU8LIC HEALTH AW SAFETY "At the end of Section 60.136 (p. 15187), NRC asks for comment on two questions

(1) Appropriateness of the 5 rem dose limit as design basis for protecting public health and safety.

RESPONSE: This dose is unacceptably high, 50 times annual natural background. The nearest to a possibly acceptable dose limit is EPA's proposed LLRW standard of 15 mrem /yr and 4 mrem /yr drinking water standard, neither of which does EPA plan to apply to NRC licensees.

Zero release facility design goal must be required for all radioactive waste management.

(2) Rationale discussed herein in support of 5 rem limit.

ECNP RESPONSE: The polite words are hard to find. An acceptable rationale is totally absent. Waste repository development is an enterprise without precedent, experience, anything approaching reliable data or proven models or demonstrated technologies. It is increasingly clear that the Federal agency's engineers and their overpaid and underperforming contractors and subcontractors really have little comprehension of what they are doing or ought to be doing. The failure of the entire waste disposal program is happening at a time when the nation no longer can afford the expense. No, NRC's rationale is not adequate to the need. We suggest NRC take DOE and itself back to the drawing board and, once again, rethink the problems before you, but recognizing that ' solutions' may [will] continue to elude you."

NRC RESPONSE:

The proposed 160.136 prescribes design criteria for Category 2 design basis events, and not radiation protection standards, per se, for those events. The Commission's radiation protection standards are provided in Part 20 and these remain the primary standards even in emergencies.

The primary utility of the 5 rem (.05 Sv) total effective dose equivalent (TEDE) design basis in 660.136 is to identify systems important to safety and design them against Category 2 design basis events. The proposed 5 rem (.05 SV) TEDE design criteria is at a level that: (1) protects against occurrence of non-stochastic effects, in the unlikely event that a Category 2 design basis event were to occur during operations, while (2) also considers the low probability of Category II design basis events in assessing the overall risk resulting from stochastic effects. For reasons explained in the Section by Section Analysis for the proposed 660.136 (60 FR 15187), NRC believes that actual doses incurred as a result of an accident caused by a Category 2 design basis event generally would be well below this value.

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o Operations expected to occur at the GROA will be similar in nature to fuel handling operations at Part 50 and Part 72 licensees. NRC anticipates that operational experiences from these facilities will be useful inputs to safety assessments for the GROA. In comparison with a facility such as a power plant, conditions are not present at a GROA to produce radioactive source terms of a magnitude that, however unlikely, are theoretically possible at a power plant. As such, consequences resulting from the limited source term would be correspondingly limited. Certain favorable siting criteria (e.g.,

low population density) as required by 660.122, would generally also contribute to limiting consequences in the unlikely event that a Category 2 design basis events occurs during the operational phase of a repository. In light of these considerations, NRC continues to believe that the potential risks to members of the public from an operating repository are very small.

In light of this limited risk, the 0.05 Sv (5 rem) dose limit provides an adequate margin of safety and an appropriate basis for the design of repository structures, systems, and components to prevent or mitigate the consequences of low probability, but credible events. The Commission's reasoning behind the 0.05 Sv (5 rem) dose limit can be found in the Section-by-Section Analysis of 660.136.

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o WISCONSIN ELECTRIC POWER COMPANY CONMENT l >

SUPPORT OF PROPOSED RULE l " Wisconsin Electric supports this proposed rule. We believe that the proposed changes are both positive and reasonable. We are encouraged by the commission's efforts toward achieving consistent licensing requirements among similar nuclear facilities."

NRC RESPONSE:

No Comment.

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k MR. MARVIN I. LEWIS COMMENTS "Please accept this letter as my comments on the Proposed Rule 10 CFR 60:

Disposal of High Level Rad Waste in Geological Repositories; Design Basis Events. 4 "The Devil is in the details.

"I have read these words in speeches given by more than one NRC Commissioner. 1 I agree that the Devil is in the details.

"The details include NRC actions such as: Cost Beneficial Licensing Actions, 1 Discretion, and just plain ignoring the facts. The NRC continues with the '

attitude which lead to the TMI #2 accident. Licensees and the NRC have forgotten the ' Lessons Learned' from TMI #2.

"These devilish details increase with the experiences gained from the ,

licensing of a geological repository. The details include: active earthquake '

faults at the center of the repository site, water intrusion into unsaturated zones believed to be dry, criticality of emplaced wastes, and harassing )

whistleblowers until they gave up employme ' with the licensee or agency.

Using these devilish details in a deficient manner will allow any site to be ,

licensed as a geological repository no matter what 10 CFR 60 requires. No where in the Proposed Rule are the devilish details of the past admitted and assurances offered to stop their continued use.

"Instead, the reference to 'The devil is in the details' and the kowtowing to licensees show that business as usual continues. The business as usual encompasses touting safety loudly and allowing licensee action which sacrifice safety in exchange for profit. 4 i

"The devil is in the details means that any action can be justified with I rationalizations and sophistry. The NRC has turned rationalization into policy thru (sic) Cost Beneficial Licensing Action, Discretion Not to Enforce Compliance, and harassment of whistleblowers.

"Also, any action can look good by inappropriate selection of underlying assumptions. One assumption used in siting repositories is that engineers can predict radioactive waste containment for hundreds or thousands of years.

This assumption contradicts past experience wherein all rad waste dumps have leaked so far.

" Engineers are human and humans can make mistakes. I am an engineer, and I can testify that I am sure that engineers make mistakes very occasionally.

Those. engineers who make a mistake on site selection of a leaking repository will not be here in a few hundred years to clean up their mistake.

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"The Answer to the Problem of Radwaste:

There are answers to the problem of radioictive waste. One obvious answer to the problem of radioactive waste is As must stop making it. Without the complications caused by an increasing waste inventory, deliberate speed will have the time necessary to produce an adequate answer to the present rad waste problem. Increases in the inventory can lead to a problem which overwhelms us.

" People have always found answers to every problem in the past. some answers ,

cause many more problems than they solve. This spiral of answers causing more problems has led civilizations to ' dusty death.'

"This spiral of answers causing more problems has led this Nation to the problem of high level radioactive waste which will not go away. Emplacement of the HL radwaste in an inadequate site is not an answer-politically, scientifically or anyway.

"Most spirals have endpoir.ts. The spiraling down of individual rights in a dictatorship leads to revolution or war. The spiraling down of mineral i i extraction leads to barren, unproductive wastelands. The spiraling down of nuclear power is leading to more high level radioactive waste. The inventory of high level radioactive wastes has increased while the demand for new plants stopped before the Three Mile Island Accident.

I "The NRC has chosen rulemaking which nibbles at the edges of the nuclear power issue. These rulemakings must address the most important issue: Will l continued use of nuclear power lead to the end of the human race?"

NRC RESPONSE:

These remarks do not relate to the substance or content of.this rulemaking.

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