[Federal Register Volume 68, Number 39 (Thursday, February 27, 2003)]
[Proposed Rules]
[Pages 9023-9032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4625]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 39 / Thursday, February 27, 2003 / 
Proposed Rules  

[[Page 9023]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 63

[Docket No. PRM-63-1]


State of Nevada; Denial of a Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking: denial.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a 
petition for rulemaking submitted by the State of Nevada. The 
petitioner requests that the NRC amend its regulations governing the 
disposal of high-level radioactive waste in a proposed geologic 
repository at Yucca Mountain, Nevada. The petitioner believes that the 
present regulations are deficient because, in petitioner's view, they 
do not provide the regulatory framework to ensure that the repository 
isolates high-level radioactive waste over the long term primarily by 
geologic means and they do not demand that the applicant provide an 
``affirmative safety case'' for the repository. These deficiencies, in 
petitioner's view, indicate that the regulations are not in full 
compliance with the Nuclear Waste Policy Act of 1982, as amended 
(NWPA), and/or the Atomic Energy Act of 1954, as amended (AEA). The NRC 
is denying the petition because: petitioner's assertion that Part 63 is 
not in full compliance with NWPA or AEA is without substance; the 
petition does not appear to present significant new factual information 
or policy recommendations that the Commission did not consider in the 
rulemaking which established Part 63, and it would be an unwise 
expenditure of resources to reconsider issues resolved in that 
rulemaking.

ADDRESSES: Copies of the petition for rulemaking and the NRC's letter 
to the petitioner are available on NRC's rulemaking Web site at http://ruleforum.llnl.gov. For information about the interactive rulemaking 
Web site, contact Carol Gallagher (301) 415-5905 or Toll Free: 1-800-
368-5642; e-mail: [email protected]. The documents may also be examined at 
the NRC Public Document Room (PDR), Room O-1F23, 11555 Rockville Pike, 
Rockville, MD.
    The NRC maintains an Agencywide Document Access and Management 
System (ADAMS), which provides text and image files of NRC's public 
documents. These documents may be accessed through NRC's Public 
Electronic Reading Room on the Internet at http://www.nrc.gov/reading-rm/adams.html. If you do not have access to ADAMS, or if there are 
problems in accessing the documents located in ADAMS, contact the NRC 
PDR Reference staff at 1-800-397-4209, or 301-415-4737; or by e-mail 
to: [email protected].

FOR FURTHER INFORMATION CONTACT: Timothy McCartin, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-7285 or Toll Free: 1-
800-368-5642, e-mail: [email protected]; or Clark Prichard, Office of 
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone (301) 415-6203 or Toll 
Free: 1-800-368-5642, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

The Petition

    On July 12, 2002, the State of Nevada submitted a ``Petition to 
Institute Rulemaking: Part 63'' (petition) which was docketed as a 
petition for rulemaking under 10 CFR 2.802 of the Commission's 
regulations (PRM-63-1). The petition requests amendments to 10 CFR Part 
63, NRC's regulations governing the disposal of high-level radioactive 
waste (HLW) in a proposed geologic repository at Yucca Mountain, Nevada 
(YM). Petitioner believes that its proposed amendments are needed to 
bring Part 63 into full compliance with the Nuclear Waste Policy Act of 
1982, as amended, 42 U.S.C. 10101 et seq. (NWPA), and to ensure that 
the Part 63 regulations, if met by the Department of Energy (DOE or 
Applicant), will provide reasonable assurance of the safety of the 
repository. Petition at 3.
    Specifically, the petition requests amendments to Part 63 as 
discussed below.

1. Section 63.15 Site Characterization

    At present, Sec.  63.15(a) provides:

    (a) DOE shall conduct a program of site characterization with 
respect to the Yucca Mountain site before it submits an application 
for a license to be issued under this part.

    Petitioner requests that the following two sentences be added:

    DOE's site characterization shall include criteria, developed 
pursuant to section 112(a) of the NWPA, to be used to determine the 
suitability of the Yucca Mountain site for the location of a 
geologic repository. Such criteria shall ensure that the geologic 
setting of the Yucca Mountain site is the primary barrier against 
the release of radionuclides to the biosphere from the multi-barrier 
repository system.

Petition at 40.

2. Section 63.21 Content of Application

    Petitioner requests that the first sentence of paragraph (a) be 
modified, and new paragraphs (c) and (d) be added, as follows:

    (a) An application consists of general information, a Safety 
Analysis Report, documentation propounding an affirmative safety 
case for the Yucca Mountain repository, and documentation that the 
site does not have any material disqualifying conditions. * * *
* * * * *
    (c) The affirmative safety case must include:
    (1) A realistic assessment of system evolution and radionuclide 
migration, drawing on natural and historical analogs.
    (2) Documentation evidencing an overall understanding by the 
applicant of the key safety-relevant factors in the repository 
system, communicated in a manner that aids in public understanding.
    (3) Disaggregated dose projections with documentation of which 
particular factors or sub-scenarios can lead to large potential 
doses, explaining as well the likelihood of occurrence of such 
scenarios.
    (4) Use of multiple performance measures showing, at a minimum, 
the effects of each isolation barrier and the spatial and temporal 
distribution of radionuclides within each component of the 
repository system.
    (5) A simplified interpretative or insight model containing only 
the key processes affecting safety, for use by the Commission and 
the public to assess the safety of the repository.
    (6) Documentation of the major conservatisms and optimisms in 
the total system performance analysis, and quantification of their 
impacts with respect to realistic post-closure assumptions.
    (7) Documentation of extreme conditions which might give rise to 
doses above

[[Page 9024]]

prescribed regulatory criteria, and a description of the factors 
that make these situations unlikely.
    (8) A description and prioritization of the isolation features 
that are considered important to keep releases and doses within 
regulatory limits and as low as is reasonably achievable.
    (9) Documentation of where the major uncertainties lie in the 
total system performance assessment and how the applicant will 
mitigate such uncertainties.
    (10) Documentation of a sensitivity case where engineered 
barriers are rendered ineffective, individually and collectively.
    (11) Presentation of the key features and results for each 
material subscenario in the repository system.
    (12) A comparison of and rebuttal to results of any scientific 
peer review of the applicant's total system performance assessment 
and/or its underlying science performed by the Nuclear Waste 
Technical Review Board, the International Atomic Energy Agency, or 
other peer reviewer designated by the applicant or the Commission.
    (d) Potentially disqualifying conditions. The following 
conditions are to be considered adverse and potentially 
disqualifying if they are characteristic of the post-closure 
controlled area at Yucca Mountain or may materially affect isolation 
within the controlled area. The application shall demonstrate that 
these disqualifying conditions do not exist or, if they do exist, 
that they are not materially adverse to the long-term safety of the 
repository.
    (1) Potential for flooding of the underground facility.
    (2) Potential for natural phenomena such as subsidence or 
volcanic activity of such a magnitude that large-scale surface water 
impoundments could be created that could change the regional 
groundwater flow system and thereby adversely affect the performance 
of the repository.
    (3) Structural deformation, such as uplift, subsidence, folding, 
or faulting that may adversely affect the regional groundwater flow 
system.
    (4) Potential for changes in hydrogeologic conditions that would 
affect the migration of radionuclides to the accessible environment, 
such as changes in hydraulic gradient, average interstitial 
velocity, storage coefficient, hydraulic conductivity, natural 
recharge, potentiometric levels, and discharge points.
    (5) Potential for changes in hydrologic conditions resulting 
from reasonably foreseeable climatic changes.
    (6) Groundwater conditions in the host rock, including chemical 
composition, high ionic strength or ranges of Eh-pH, that could 
increase the solubility or chemical reactivity of the engineered 
barrier system.
    (7) Geochemical processes that would reduce sorption of 
radionuclides, result in degradation of the rock strength, or 
adversely affect the performance of the engineered barrier system.
    (8) Groundwater conditions in the host rock that are not 
reducing.
    (9) Evidence of dissolutioning such as breccia pipes, 
dissolution cavities, or brine pockets.
    (10) Structural deformation such as uplift, subsidence, folding, 
and faulting during the Quaternary Period.
    (11) Earthquakes that have occurred historically that if they 
were to be repeated could affect the site significantly.
    (12) Indications, based on correlations of earthquakes with 
tectonic processes and features, that either the frequency of 
occurrence or magnitude of earthquakes may increase.
    (13) More frequent occurrence of earthquakes or earthquakes of 
higher magnitude than is typical of the area in which the geologic 
setting is located.
    (14) Evidence of igneous activity since the start of the 
Quaternary Period.
    (15) Evidence of extreme erosion during the Quaternary Period.
    (16) The presence of naturally occurring materials, whether 
identified or undiscovered, within the site, in such form that:
    (i) Economic extraction is currently feasible or potentially 
feasible during the foreseeable future; or
    (ii) Such materials have greater gross value or net value than 
the average for other areas or similar size that are representative 
of and located within the geologic setting.
    (17) Rock or groundwater conditions that would require complex 
engineering measures in the design and construction of the 
underground facility or in the sealing of boreholes and shafts.
    (18) Geomechanical properties that do not permit design of 
underground opening that will remain stable through permanent 
closure.
    (19) Potential for the water table to rise sufficiently so as to 
cause saturation of an underground facility located in the 
unsaturated zone.
    (20) Potential for existing or future perched water bodies that 
may saturate portions of the underground facility or provide a 
faster flow path from an underground facility located in the 
unsaturated zone to the accessible environment.
    (21) Potential for the movement of radionuclides in a gaseous 
state through air-filled pore spaces of an unsaturated geologic 
medium to the accessible environment.

Petition at 40-43.

3. Section 63.113 Performance Objectives for the Geologic Repository 
After Permanent Closure

    Petitioner requests that new paragraphs (e) and (f) be added to 
this section, as follows:

    (e) Geologic Setting. The geologic setting for the Yucca 
Mountain repository shall evidence a pre-waste-emplacement 
groundwater travel time along the fastest path of likely 
radionuclide travel from the disturbed zone to the accessible 
environment of at least 1,000 years.
    (f) Peak Dose. The geologic setting for the Yucca Mountain 
repository shall evidence sufficient geologic suitability to provide 
reasonable assurance that peak radiation doses to the accessible 
environment will not occur subsequent to the regulatory monitoring 
period established by the Environmental Protection Agency in 40 CFR 
Part 197.

Petition at 43.

4. Section 63.115 Requirements for Multiple Barriers

    Petitioner requests that a new paragraph (d) be added to this 
section, as follows:

    (d) The natural features of the geologic setting shall 
constitute the primary barrier for assuring the long-term isolation 
of high-level radioactive waste and spent nuclear fuel at the 
proposed geologic repository at Yucca Mountain.

Petition at 44.

5. Section 63.311 Individual Protection Standard After Permanent 
Closure

    Petitioner requests that the words ``a reasonable expectation'' in 
this section be replaced with the words ``reasonable assurance'' so 
that it reads as follows:

    DOE must demonstrate, using performance assessment, that there 
is reasonable assurance that, for 10,000 years following disposal, 
the reasonably maximally exposed individual receives no more than an 
annual dose of 0.15 mSv (15 mrem) from releases from the undisturbed 
Yucca Mountain disposal system. DOE's analysis must include all 
potential pathways of radionuclide transport and exposure.

    In addition, petitioner requests that Sec.  63.304, providing a 
definition of ``reasonable expectation,'' be deleted in its entirety.

Supporting Information

    Petitioner believes that the present Part 63 rule is ``materially 
deficient'' for two reasons: (1) it ``does not now provide the 
regulatory framework to assure that the repository isolates [HLW] over 
the long term primarily by geologic means;'' and (2) it ``does not 
demand of the applicant that it provide an affirmative safety case for 
the repository.'' Petition at 4. Lacking these two ``fundamental 
prerequisites,'' Part 63, in petitioner's view, ``fails to assure the 
long-term safety of the repository or its compliance with the statutory 
requirements of the NWPA.'' Id. Petitioner identifies five basic 
elements to be added to Part 63: (1) Provisions ensuring that geologic 
isolation is the primary barrier against the release of radiological 
contamination to the environment, (2) provisions requiring the 
submission of an affirmative safety case, (3) provisions requiring the 
verification of the lack of materially adverse or potentially 
disqualifying conditions for Yucca Mountain following closure of the 
repository, and (4) provisions relating to the provision of 
``reasonable assurance'' of the safety of the repository. Petition at 
39.

[[Page 9025]]

The Primacy of Geologic Criteria for HLW Isolation

    Petitioner asserts that 10 CFR Part 63 must be revised such that it 
assures that the repository will isolate HLW primarily by geologic 
means both as a matter of law and as a matter of sound science. To 
support its ``law'' position, petitioner argues that the plain language 
of sections 112(a) and 113(b)(1) of NWPA, together with the legislative 
history of these sections, requires that geologic isolation be the 
primary form of containment for waste at the YM repository. Petition at 
11-18. Section 112(a) requires DOE to issue guidelines for the 
recommendation of sites for repositories which, inter alia, must 
``specify detailed geologic considerations that shall be primary 
criteria for the selection of sites in various geologic media'' and 
which ``shall specify factors that qualify or disqualify any site from 
development as a repository, including factors pertaining to * * * 
hydrology, geophysics [and] seismic activity * * *'' Petitioner claims 
that this section obligates the NRC to set the same requirements for 
the YM repository. Petition at 11--12.
    To support its ``sound science'' position, petitioner provides a 
detailed history of scientific studies that petitioner says underlie 
``the requirement of Section 112(a) of the NWPA that any repository in 
this nation must isolate radioactive waste primarily by geologic 
means.'' Petition at 6; see Petition at 6-11. Petitioner also points to 
the Affidavit of Dr. John W. Bartlett, a former Director of DOE's HLW 
program at YM. Petition, Attachment 1. Dr. Bartlett questions DOE's 
finding that YM is a site suitable for a repository. He does not 
comment on NRC's regulations except to observe the different functions 
of the two agencies in Congress' scheme for a repository: ``Congress 
made it clear that DOE was to determine the suitability of the site, 
while the NRC was to determine the licenseability of the repository 
system (i.e., the site plus its engineered features).'' Id. at 9 
(emphasis in original).
    Petitioner states that, initially, NRC, DOE and EPA each published 
rules which ``individually and collectively conformed generally to the 
requirements of NWPA Section 112,'' i.e., 10 CFR Part 60, 10 CFR Part 
960 and 40 CFR Part 191, respectively. Petition at 18. Petitioner notes 
that, with respect to Part 60, the Commission decided to set subsystem 
performance requirements that serve the function of qualifying and 
disqualifying criteria for site variables, such as groundwater travel 
time, radionuclide travel times and margin of safety (assuming failure 
of the engineered barriers) but that the Commission ``abandoned'' these 
requirements in Part 63. Petition at 21-22. Petitioner believes that 
this abandonment not only violates NWPA but also violates ``NRC's legal 
obligation [under section 161b. of the Atomic Energy Act] to apply 
these basic scientific prerequisites in providing for reasonable 
assurance of the safety of the repository * * *.'' Id.

The Need for an Affirmative Safety Case

    Petitioner also contends that 10 CFR Part 63 must be revised so 
that it requires DOE, as the applicant for a license, to present ``an 
affirmative safety case'' for the repository. Petitioner admits that 
``[a]s written, Part 63 arguably provides the regulatory framework to 
establish whether the Yucca Mountain repository will satisfy the 
radiological release criteria set by [EPA],'' Petition at 4, but 
believes that this is insufficient to demonstrate that the repository 
is safe. According to petitioner, to demonstrate that the repository is 
safe, NRC must require demonstration of an understanding of repository 
performance, including that the geologic setting of the repository 
will, in fact, protect the public from the danger of radioactive 
releases whenever such releases might occur. Petition at 33-34. At 
present, petitioner asserts, the repository will become most dangerous 
to humans and the environment after the 10,000 year regulatory time 
period, a ``blatantly unsafe condition'' which should prevent the 
licensing of the repository. Petition at 33; see Attachment 2. 
Petitioner supports its view that an affirmative safety case is needed 
by incorporating criticisms of DOE's Total System Performance 
Assessment for the site recommendation process (TSPA-SR) made in a 
report by an international peer review, An International Peer Review of 
the Yucca Mountain Project TSPA-SR, March 2002 (Peer Review).\1\ 
Petition at 34-38. Petitioner also cites criticisms of DOE's scientific 
work in preparation for a site recommendation made by the Nuclear Waste 
Technical Review Board and NRC's Advisory Committee on Nuclear Waste. 
Petition, Attachment 3.
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    \1\ DOE issued its TSPA-SR in December 2000. DOE subsequently 
requested a peer review which was carried out by a review team 
selected by the Nuclear Energy Agency of the Organization for 
Economic Co-Operation and Development and the International Atomic 
Energy Agency.
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Reasons for Denial

    NRC is denying the petition because:
    (1) Petitioner's assertion that 10 CFR part 63 is not in full 
compliance with NWPA or AEA is without substance.
    (2) The Commission promulgated 10 CFR part 63 little over a year 
ago after an extensive rulemaking process that provided an enhanced 
level of stakeholder participation. The petition does not appear to 
present any significant new factual information or policy 
recommendations that the Commission has not already considered and it 
would be an unwise expenditure of resources to reconsider issues 
already resolved in the part 63 rulemaking.

1. 10 CFR part 63 Is in Full Compliance With Statutory Requirements

    Petitioner asserts that current part 63 regulations are not in full 
compliance with NWPA. Petition at 3. This is because, in petitioner's 
view, the current rule does not ``provide the regulatory framework to 
assure that the repository isolates high-level radioactive waste over 
the long term primarily by geologic means.'' Petition at 4. Petitioner 
further asserts that the rule is deficient, under section 161b. of the 
Atomic Energy Act of 1954, as amended (AEA), 42 U.S.C. 2201(b), because 
the rule does not require the applicant to provide ``an affirmative 
safety case'' for the repository. Petition at 4, 22. Petitioner 
misreads the Commission's duty under both of these statutes. As 
explained below, the Commission finds no legal infirmity in the current 
Part 63 regulations and thus there is no reason to amend Part 63 to 
cure any supposed lack of conformity with NWPA or AEA.
a. 10 CFR Part 63 Is in Cccord With NWPA Requirements
    Congress first spelled out directions for rulemakings to be 
undertaken to set requirements for a repository in section 121 of NWPA 
as enacted in 1982, 42 U.S.C. 10141. The Environmental Protection 
Agency (EPA) was to ``promulgate generally applicable standards for 
protection of the general environment from offsite releases from 
radioactive material in repositories'' (sec. 121(a)), and NRC, 
``pursuant to authority under other provisions of law,'' was ``by rule, 
[to] promulgate technical requirements and criteria that it will apply 
* * * in approving or disapproving * * * applications for authorization 
to construct repositories [and] applications for licenses to receive 
and possess spent nuclear fuel and [HLW] in such repositories * * *'' 
(sec. 121(b)(1)(A)). Congress placed only three restrictions on the 
substance of the regulations NRC was to promulgate:
    (1) NRC's criteria ``shall provide for the use of a system of 
multiple barriers

[[Page 9026]]

in the design of the repository'' (sec. 121(b)(1)(B));
    (2) NRC's criteria ``shall include such restrictions on the 
retrievability of the solidified [HLW] and spent fuel emplaced in the 
repository as the Commission deems appropriate'' (sec. 121(b)(1)(B)); 
and
    (3) NRC's criteria ``shall not be inconsistent with any comparable 
standards promulgated by the Administrator under subsection (a)'' (sec. 
121(b)(1)(C)).
    The first of these restrictions shows that although Congress did 
require NRC to provide for ``multiple barriers'' for waste isolation, 
it did not specify that geologic barriers must be primary or qualify 
the ``multiple barriers'' requirement in any other way.
    Congress amended NWPA in 1987 to focus the national waste program 
exclusively on the characterization of the YM site as a potential 
geologic repository, but did not alter section 121 or otherwise place a 
requirement on NRC to make geologic barriers the primary means of waste 
isolation in its rules. Pub. L. 100-203 (101 Stat. 1330). Congress 
again revised the national waste program in the Energy Policy Act of 
1992 (EnPA), Pub. L. 102-486, October 24, 1992. In the EnPA, Congress 
directed EPA to promulgate standards applicable solely to the Yucca 
Mountain site and directed NRC to modify its technical requirements and 
criteria under section 121(b) of NWPA, as necessary, to be consistent 
with EPA's standards. Section 801 of EnPA. EnPA did not direct either 
EPA or NRC to require that geologic barriers be the primary form of 
waste isolation.\2\
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    \2\ Section 801(b)(2) of EnPA did place a further restriction on 
NRC's rules for a repository by requiring NRC to incorporate into 
its rules assumptions, consistent with the findings and 
recommendations of the National Academy of Sciences (NAS), 
pertaining to the sufficiency of engineered barriers and DOE's post-
closure oversight to prevent human activity causing a breach of the 
repository and to prevent any increase in the exposure of individual 
members of the public to radiation beyond allowable limits. However, 
NAS concluded that these assumptions were not scientifically 
justified and Part 63 is not based on these assumptions.
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    NRC initially established its procedural rules for a repository in 
1981 in a new 10 CFR Part 60. (46 FR 13971; February 25, 1981). In 
1983, NRC incorporated technical requirements into Part 60, as directed 
by NWPA. (48 FR 28194; June 21, 1983). The Commission explained that 
the purpose of the technical criteria was ``to define more clearly the 
bases upon which licensing determinations will be made * * .*'' (48 FR 
28195). The Commission acknowledged that licensing decisions would be 
complicated by the uncertainties that are associated with predicting 
the behavior of a geologic repository over thousands of years and 
stated that it intended to address this difficulty by requiring that a 
DOE proposal be based upon a multiple barrier approach:

    An engineered barrier system is required to compensate for 
uncertainties in predicting the performance of the geologic setting, 
especially during the period of high radioactivity. Similarly, 
because the performance of the engineered barrier system is also 
subject to considerable uncertainty, the geologic setting must be 
able to contribute significantly to isolation.

Id. The Commission did not specify that either the engineered or the 
geologic barriers be primary. However, the Commission did elect to 
implement this approach by establishing a number of performance 
objectives and detailed siting and design criteria that it ``deemed 
appropriate'' for a multi-barrier system. Id., fn 2. The Commission 
identified ``two potentially viable approaches'' to achieving the goal 
of waste isolation: (a) An approach ``that would prescribe minimum 
performance standards for each of the major elements of the geologic 
repository, in addition to prescribing the EPA standard as a single 
overall performance standard;'' and (b) an approach ``that would 
specify the EPA standard as the sole measure of isolation 
performance.'' (48 FR 28196). In short, the Commission believed it was 
legally free to adopt either approach. The Commission adopted the first 
approach in order to convey ``in [a] meaningful way the degree of 
confidence which it expects must be achieved in order for it to be able 
to make the required licensing decisions.'' Id. It, therefore, adopted 
a regulation setting sub-system performance standards, although with a 
provision allowing modifications on a case-by-case basis.\3\ See 10 CFR 
60.113.
---------------------------------------------------------------------------

    \3\ Contrary to petitioner's assertions, the Commission did not 
view the sub-system requirements as the ``essential prerequisites to 
establishing a safe repository,'' Petition at 22, but rather as a 
means of increasing confidence in its licensing decisions, given the 
uncertainties and technical methods for evaluating repository 
performance available in 1983.
---------------------------------------------------------------------------

    As explained above, EnPA required NRC to modify its technical 
requirements to assure consistency with EPA's standards for a 
repository at YM. In response to this mandate, NRC published a proposed 
rule to establish a new, separate part of its regulations at 10 CFR 
Part 63. (64 FR 8640; February 22, 1999). The proposed rule was 
designed to do more than simply conform NRC's technical requirements to 
an EPA standard. The Commission recognized that in the 15 years since 
the Part 60 technical criteria had been put in place, there had been 
``considerable evolution in the capability of technical methods for 
assessing the performance of a geologic repository at Yucca Mountain 
[and that] * * * their implementation for Yucca Mountain [would] avoid 
the imposition of unnecessary, ambiguous, or potentially conflicting 
criteria that could result from the application of some of the 
Commission's generic requirements at 10 CFR Part 60.'' (64 FR 8641). In 
addition, the Commission recognized an opportunity to establish 
criteria compatible with the Commission's overall philosophy of risk-
informed and performance-based regulation:

    [T]he creation of a new part of its regulations to [achieve 
risk-informed, performance-based regulations] is preferable to 
modifying its generic requirements, given the fundamentally 
different approach laid out for Yucca Mountain by EnPA and NAS than 
was contemplated when the generic criteria were promulgated. More 
specifically, EnPA and NAS have specified an approach that would 
require the performance of a Yucca Mountain repository to comply 
with a health-based standard established in consideration of risk to 
a hypothetical critical group, and, further, that this would be the 
only quantitative standard for the post-closure performance of the 
repository. This approach is incompatible with the approach taken in 
the existing generic criteria which relies on quantitative, 
subsystem performance standards.

(64 FR 8643). The Commission decided to reexamine its implementation of 
a multiple barrier approach and propose a regulation which required a 
system of multiple barriers, but which did set numerical goals for the 
performance of individual barriers. See 64 FR 8647-50. Instead, DOE was 
required to demonstrate that the natural barriers and the engineered 
barrier system would work in combination to enhance overall performance 
of the geologic repository.\4\
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    \4\ In this reexamination, the Commission noted that the Sec.  
60.113 subsystem criteria ``[had] not gained broad acceptance in the 
technical community'' and had been ``criticized as overly 
prescriptive, lacking in both a strong technical basis and a clear 
technical nexus to the overall performance objective * * *.'' (64 FR 
8649). Further, the Commission noted that NAS had found, in 1995, 
that ``the physical and geologic processes relevant to a Yucca 
Mountain repository * * * are sufficiently quantifiable and the 
related uncertainties sufficiently boundable that the performance of 
a repository can be assessed over timeframes during which the 
geological system is relatively stable or varies in a boundable 
manner.'' Id. (quotations omitted). Moreover, ``experience and 
improvements in the technology of performance assessment, acquired 
over more than 15 years, now provide significantly greater 
confidence in the technical ability to assess comprehensively 
overall repository performance, and to address and quantify the 
corresponding uncertainty.'' Id.

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[[Page 9027]]

    In the final rule (66 FR 55732; November 2, 2001), the Commission 
---------------------------------------------------------------------------
clarified the intent of NWPA's multi-barrier provision:

    Section 63.113(a) requires that the geologic repository include 
multiple barriers, both natural and engineered. Geologic disposal of 
HLW is predicated on the expectation that one or more aspects of the 
geologic setting will be capable of contributing to the isolation of 
radioactive waste and thus be a barrier important to waste 
isolation. * * * The performance assessment provides an evaluation 
of the repository performance based on credible methods and 
parameters including the consideration of uncertainty in the 
behavior of the repository system. Thus the performance assessment 
results reflect the capability of each of the barriers to cope with 
a variety of challenges. * * * A description of each barrier's 
capability * * * as reflected in the performance assessment, 
provides an understanding of how the natural barriers and the 
engineered barrier system work in combination to enhance the 
resiliency of the geologic repository. The Commission believes that 
this understanding can increase confidence that the postclosure 
performance objectives specified at Sec.  63.113(b) and (c) will be 
achieved and that DOE's design includes a system of multiple 
barriers.

10 CFR 63.102(h); see 66 FR 55758. The Commission placed the 
requirements for multiple barriers in Sec.  63.115.
    In sum, the NWPA as enacted in 1982 requires that NRC's regulations 
for a repository must specify the use of a system of multiple barriers. 
Neither Congress' amendment of NWPA in 1987 nor its enactment of EnPA 
in 1992 altered that direction. None of this legislation required that 
geologic considerations were to be the primary criteria for licensing a 
repository. NRC's technical criteria in Part 60, issued in 1983 in 
response to NWPA's direction, did not make geologic barriers the 
primary criteria but did, in implementing the multi-barrier 
requirement, set separate numerical criteria for both the engineered 
and the geologic barriers to meet. NRC reconsidered this approach in 
2001 when it issued regulations governing DOE's license application for 
a repository at YM and decided not to include subsystem requirements. 
NRC provided a detailed explanation of its reasons for altering its 
approach for implementing NWPA's multi-barrier requirement. We have no 
doubt that Part 63 fully complies with Congress' statutory directions 
to NRC.
    Petitioner ignores section 121 of NWPA--which speaks directly to 
NRC's duty with respect to issuing regulations for the repository--and, 
instead, locates the asserted duty of the Commission to establish 
regulations requiring that geologic isolation be the primary form of 
containment for HLW in sections 112(a) and 113(b)(1) of the NWPA, 42 
U.S.C. 10132(a) and 10133(b)(1).\5\ Petition at 11-18. Because these 
provisions of NWPA place obligations on DOE, rather than NRC, they do 
not govern NRC's rulemakings for a geologic repository.
---------------------------------------------------------------------------

    \5\ The 1987 amendments to NWPA did not revise section 112(a) 
but did revise section 113(b) to make its provisions applicable 
solely to the characterization of the YM site, rather than any 
candidate site.
---------------------------------------------------------------------------

    As relevant here, section 112(a) provides:

    SEC. 112. (a) GUIDELINES.--Not later than 180 days after the 
date of enactment of this Act, the Secretary, following consultation 
with the Council on Environmental Quality, the Administrator of the 
Environmental Protection Agency, the Director of the Geological 
Survey, and interested Governors, and the concurrence of the 
Commission shall issue general guidelines for the recommendation of 
sites for repositories. Such guidelines shall specify detailed 
geologic considerations that shall be primary criteria for the 
selection of sites in various geologic media. Such guidelines shall 
specify factors that qualify or disqualify any site from development 
as a repository. * * * Such guidelines shall require the Secretary 
to consider the various geologic media in which sites for 
repositories may be located and, to the extent practicable, to 
recommend sites in different geologic media. The Secretary shall use 
guidelines established under this subsection in considering 
candidate sites for recommendation under subsection (b). The 
Secretary may revise such guidelines from time to time, consistent 
with the provisions of this subsection.

42 U.S.C. 10132(a). Under section 112(b), the Secretary is to nominate 
at least 5 sites determined to be suitable for site characterization 
and, subsequent to such nomination, to recommend to the President 3 of 
the nominated sites for characterization as candidate sites. Each 
nomination of a site is to be accompanied by an environmental 
assessment which includes, inter alia, ``an evaluation by the Secretary 
as to whether such site is suitable for site characterization under the 
guidelines established under subsection (a).'' Section 112(b)(1)(D)(i).
    The most obvious reason why these provisions of NWPA do not demand 
that NRC issue regulations requiring that geologic barriers be primary 
is that these provisions give direction to the Secretary of DOE, not to 
NRC. Petitioner assumes that the mandate given to DOE to formulate 
guidelines for the nomination, and then selection, of sites for 
characterization applies equally to NRC in promulgating its 
regulations. But there is no statutory language to support this. 
Petitioner may believe that although the statute itself is silent on 
any NRC duty to make geologic barriers primary, this result must 
necessarily follow from the duty placed on DOE to issue guidelines 
specifying ``detailed geologic considerations that shall be primary 
criteria for the selection of sites in various geologic media.'' 
Section 112(a). It may be readily acknowledged that it would make 
little sense for Congress to establish a system for selecting a 
repository where DOE guidelines for selection of sites and NRC 
regulations for licensing a repository would contradict each other.\6\ 
But there is no such contradiction. DOE's guidelines are for the 
purpose of comparing a multitude of alternate site possibilities, an 
inquiry for which it makes obvious good sense for geologic 
considerations to be paramount.\7\ NRC's licensing regulations are for 
the purpose of examining DOE's application for a repository at an 
already-chosen site--i.e., one that has gone through the section 112 
screening process. Such a site would have already passed the section 
112 tests for geologic considerations in the DOE guidelines. Congress 
thus had no need to require, and did not require, NRC to issue 
regulations making geologic considerations the ``primary'' criteria for 
approval of DOE's license application for the repository.
---------------------------------------------------------------------------

    \6\ In fact, DOE's need to seek NRC's concurrence on its 
guidelines assures that there will be no such conflict.
    \7\ As enacted in 1982, the section 112(a) guidelines were 
intended for use in the nomination and selection of candidate sites 
for a second repository as well as for the identification and study 
of further sites after the approval of candidate sites for 
characterization for two repositories. See sections 112(b)(1)(C) and 
112(d) of the 1982 NWPA.
---------------------------------------------------------------------------

    Petitioner seeks to bootstrap the section 112(a) site selection 
guidelines into the requirement in section 113 that DOE prepare a site 
characterization plan which shall include ``criteria to be used to 
determine the suitability of such candidate site for the location of a 
repository, developed pursuant to section 112(a).'' Section 
113(b)(1)(A)(iv). See Petition at 11-12. If the criteria for site 
characterization for determination of suitability for a repository 
required by section 113 are the same as the guidelines required by 
section 112, then, petitioner assumes, DOE may not recommend a site to 
the President for approval under section 114 unless the site has been 
shown to meet the guidelines, including the guideline that geologic 
considerations be the primary criteria for selection. On the same 
theory, petitioner also claims the NRC

[[Page 9028]]

must promulgate regulations requiring that geologic considerations be 
the primary criteria for approval of a license application.
    Petitioner makes several unwarranted leaps in arriving at these 
conclusions. The first is that Congress intended that the criteria 
required under section 113 be the same as the guidelines required under 
section 112. DOE considered this question at considerable length when 
it issued its criteria for consideration of the YM site. (66 FR 57298, 
57311-12; November 14, 2001). DOE concluded that Congress' directive in 
section 113(b)(1)(A)(iv) that the criteria to be used to determine the 
suitability of a candidate site for the location of a repository be 
``developed pursuant to section 112(a)'' is best understood as 
``mandating observance of the special procedural requirements of 
section 112(a) in formulating or altering the section 113(b) 
`criteria,' '' i.e., the requirements to consult with specific agencies 
and to get concurrence from NRC, and not as requiring that the 
``criteria'' be the guidelines themselves. (66 FR 57312). Second, even 
assuming, arguendo, that the criteria were intended to be the 
guidelines--and we have no reason to quarrel with DOE's interpretation 
of its own statutory mandate--that still would not oblige NRC to craft 
its regulations under DOE's criteria. There would be no contradiction 
between DOE's recommending a site as suitable for a repository, based 
primarily on geologic considerations, and NRC's issuing regulations 
under which a repository would be approved, based upon the existence of 
multiple barriers, but not necessarily on geologic ``primacy.''
    In sum, because sections 112 and 113 of NWPA place no obligations 
on NRC with respect to rulemakings for a geologic repository, and 
because part 63 is in full conformance with section 121 of NWPA which 
does spell out NRC's rulemaking obligations, we reject petitioner's 
claim that part 63 is not in full conformance with NWPA and deny the 
petition.
b. 10 CFR Part 63 is in Accord With AEA Requirements
    Petitioner asserts that because part 63 does not demand that the 
applicant provide ``an affirmative safety case'' for the repository, 
``the rule is materially deficient.'' Petition at 4. In petitioner's 
view, a requirement that DOE conduct a total system performance 
assessment ``to determine whether a primary radiological standard set 
by the EPA can be met by the overall repository system, and not by any 
particular subsystem or any particular isolation barrier'' is not 
adequate. Petition at 22. Rather, ``under NRC's plenary safety 
jurisdiction (Atomic Energy Act Section 161b) * * * it would remain 
NRC's legal obligation to apply these basic scientific prerequisites 
[found in section 112(a) of NWPA] in providing for reasonable assurance 
of the safety of the repository. * * *''\8\ Id.; see also petition at 
32.
---------------------------------------------------------------------------

    \8\ Petitioner erroneously believes that DOE was exempt from 
regulation by NRC under section 161b. of the AEA until passage of 
NWPA in 1982. In fact, NRC's authority over DOE, with respect to an 
application for a license for a geologic repository, stems from 
section 202(3) of the Energy Reorganization Act of 1974 (ERA), 42 
U.S.C. 5842(3), which provides that NRC shall have licensing and 
related regulatory authority pursuant to chapters 6, 7, 8, and 10 of 
the AEA with respect to DOE ``facilities used primarily for the 
receipt and storage of [HLW] resulting from activities licensed 
under [the AEA].'' Thus, in 1981, when NRC issued its original rule 
governing a DOE license application for a repository at 10 CFR Part 
60, the Commission cited section 202 as the authority for the rule, 
noting that it interpreted ``storage'' as used in this section to 
include disposal. (46 FR 13971 n.1; February 25, 1981). Neither NWPA 
nor EnPA provided NRC with rulemaking authority; rather NWPA 
directed NRC, ``pursuant to authority under other provisions of 
law,'' to promulgate the technical requirements and criteria it 
would employ to consider a DOE license application for a repository 
(sec. 121(b) of NWPA) and EnPA required NRC to modify its technical 
requirements to be consistent with standards to be promulgated by 
EPA. Section 801(b)(1) of EnPA. For these reasons, we agree with 
petitioner that part 63 must be consistent with section 161b. of the 
AEA.
---------------------------------------------------------------------------

    Section 161b. of the AEA provides, in relevant part:

    Sec. 161. General Provisions.
    In the performance of its functions the Commission is authorized 
to--
    * * *
    b. establish by rule, regulation, or order, such standards and 
instructions to govern the possession and use of special nuclear 
material, source material, and byproduct material as the Commission 
may deem necessary or desirable to promote the common defense and 
security or to protect health or to minimize danger to life and 
property. * * *

    We agree with petitioner that ``[t]his is clearly an extremely 
broad grant of authority.'' Petition at 6 n.2. The Commission is 
granted wide discretion to determine what standards are necessary or 
desirable to protect health and minimize danger to life and property. 
Through an extensive and open public process, the Commission set forth 
its post-closure public health and environmental standards in subpart L 
of part 63. Petitioner, however, is dissatisfied with these standards 
and would require inclusion of the DOE guidelines listed in section 
112(a) of NWPA and/or the requirements preferred by the Peer Review. 
However, there is no statute requiring the Commission to make these 
choices rather than the standards the Commission, in fact, deemed 
sufficient for a determination that the repository will not pose an 
unreasonable risk to the health and safety of the public. See 10 CFR 
63.31(a)(2); 63.41(c). Petitioner has not presented any new information 
that causes the Commission to reconsider choices already made in an 
extensive and recent rulemaking proceeding. See infra. Thus, we remain 
satisfied that the part 63 rules fully comply with the Commission's 
duty, under section 161b. of the AEA to establish standards to protect 
health and minimize danger to life and property.

2. Reopening the Final 10 CFR Part 63 Rule Would Be an Unwise 
Expenditure of Resources Because the Petition Does Not Appear To 
Present Any Significant New Factual Information Not Previously 
Considered During the Rulemaking Proceeding

    On February 22, 1999 (64 FR 8640), the Commission published its 
proposed rule to establish licensing criteria for the disposal of HLW 
in the proposed geologic repository at YM. The public comment period, 
originally ending on May 10, 1999, was extended to June 30, 1999, in 
response to many requests for extension. During the public comment 
period, the NRC staff held a series of public meetings in Nevada to 
discuss the proposed rule and solicit public comment. The final rule 
was published on November 2, 2001 (66 FR 55732). Petitioner had 
multiple opportunities to file, and did file, extensive comments on the 
proposed rule, all of which were carefully considered by the Commission 
before issuing the final rule. We do not find in the petition 
significant new factual or policy information not already considered in 
the rulemaking that established part 63. Given this, and our recent 
consideration (in the part 63 rulemaking) of essentially the same 
questions petitioner now raises, it would not be a wise expenditure of 
resources to reopen these issues.
    We briefly recount below the concerns that petitioner now raises as 
``material deficiencies,'' but were in actuality resolved in the part 
63 rulemaking.
Reasonable Expectation
    Petitioner objects to the Commission's use of ``reasonable 
expectation,'' rather than ``reasonable assurance,'' to describe the 
degree of certainty to be obtained for the compliance of the repository 
with the post-closure performance standards. Petition at 3, n.1. The 
Commission has fully explained why it incorporated ``reasonable 
expectation,'' rather than ``reasonable assurance,'' into its 
implementing regulations for YM. See

[[Page 9029]]

66 FR 55739--40. The Commission stated that ``irrespective of the term 
used, the Commission will consider the full record before it [and] 
[t]hat record will include many factors in addition to whether the site 
and design comply with the performance objectives (both preclosure and 
postclosure performance standards) contained in Subparts E, K and 
L.''\9\ (66 FR 55740). Petitioner has not raised any objection to this 
standard that was not already fully considered. Thus, we decline to 
amend part 63 to reverse the decision made in the rulemaking for part 
63.
---------------------------------------------------------------------------

    \9\ The Commission noted that it ``could consider the QA 
program, personnel training program, emergency plan and operating 
procedures, among others, in order to determine whether it has 
confidence that there is no unreasonable risk to the health and 
safety of the public.'' (66 FR 55740; November 2, 2001).
---------------------------------------------------------------------------

Primacy of the Geologic Barrier
    Petitioner requests that part 63 be revised to require that the 
geologic setting of the YM site be the primary barrier against release 
of radionuclides to the biosphere and a separate criterion be specified 
for the geologic setting (pre-waste-emplacement groundwater travel time 
along the fastest path of likely radionuclide travel from the disturbed 
zone to the accessible environment of at least 1,000 years). The role 
of the geologic setting, including the imposition of separate criteria 
for individual barriers (or sub-system requirements) was an important 
consideration during the development of part 63. NRC's generic 
regulations for HLW disposal at 10 CFR part 60 prescribe criteria for 
individual barriers. Petitioner's request would serve to continue the 
part 60 sub-system approach. See 10 CFR 60. 113(a)(2).
    The Commission carefully considered the merits of including these 
types of barrier criteria when it proposed part 63, but decided against 
doing so:

    Upon review * * * the Commission is persuaded that much of the 
basis for NRC's initial development of the specific numerical values 
for the subsystem criteria was generic judgment with regard to what 
was (and was not) feasible with regard to the quantitative 
assessment of long-term repository performance. Because the stated 
goal was to compensate for uncertainty, there was never any attempt 
to derive the subsystem performance criteria from a specified dose 
or risk level or from some projected dose or risk reduction expected 
to be achieved by their application. Furthermore, after 15 years of 
experience in working with the requirements of part 60, the 
Commission is concerned that, for the Yucca Mountain site, the 
application of the subsystem performance criteria at Sec.  60.113 
may impose significant additional expenditure of resources on the 
nation's HLW program, without producing any commensurate increase in 
the protection of public health and safety.

(64 FR 8649; February 22, 1999). Nevertheless, the Commission 
acknowledged the importance of the geologic setting:

    [D]espite its reconsideration of the merits of establishing 
quantitative criteria for the performance of repository subsystems, 
the Commission continues to believe that multiple barriers, as 
required by NWPA, must each make a definite contribution to the 
isolation of waste at Yucca Mountain, so that the Commission may 
find, with reasonable assurance, that the repository system will be 
able to achieve the overall safety objective over timeframes of 
thousands of years. Geologic disposal of HLW is predicated on the 
expectation that a portion of the geologic setting will act as a 
barrier, both to water reaching the waste, and to dissolved 
radionuclides migrating away from the repository, and thus, 
contribute to the isolation of radioactive waste.

Id. The proposed rule required DOE to provide an analysis that (1) 
identifies those design features of the engineered barrier system, and 
natural features of the geologic setting, that are considered barriers 
important to waste isolation; (2) describes the capability of these 
barriers to isolate waste, taking into account uncertainties in 
characterizing and modeling the barriers; and (3) provides the 
technical basis for the description of the capability of these 
barriers. The Commission stated that this approach would ``provide for 
a system of multiple barriers and an understanding of the resiliency of 
the geologic repository provided by the barriers important to waste 
isolation to ensure defense in depth and increase confidence that the 
postclosure performance objective will be achieved.''

(64 FR 8650; February 22, 1999).
    NRC received comments both supporting and opposing its proposed 
approach for evaluating individual barriers, including a comment from 
petitioner requesting that the part 60 approach be retained. After 
careful consideration of these comments, the Commission decided to 
retain the proposed approach because:

    1. It provides the Commission with information to be considered 
in its decisions without constraining its considerations to a 
specific limit for a particular barrier, which could result in less 
favorable overall system performance.
    2. It gives the Commission the flexibility to consider the 
nature and extent of conservatism in the evaluations used for 
compliance demonstration, and to decide whether there is a need to 
require DOE to reduce uncertainties in its assessment (e.g., 
collecting more site data) or to include further mitigative 
measures.
    3. Quantitative evidence of the capability of individual 
barriers to contribute to waste isolation is an integral part of the 
performance assessment. Therefore, an additional quantitative limit 
is not necessary to show that overall performance reflects a system 
of multiple barriers.
    The Commission understands that establishment of explicit, 
quantitative limits for individual barriers might be considered a 
desirable and more easily explained approach. That being said, 
however, the Commission knows of no scientific basis for setting 
such limits for particular barriers at Yucca Mountain, or at any 
other site, independent of the complex repository system in which 
they must perform. The Commission is confident that evidence for the 
resilience, or lack of resilience, of a multiple-barrier system will 
be found by examining a comprehensive and properly documented 
performance assessment of the behavior of the overall repository 
system. Such an assessment must consider credible and supportable 
ranges of individual parameters and modeling assumptions, and must 
include multiple evaluations of a wide range of combinations of 
resulting barrier performance.

(66 FR 55759; November 2, 2001).
    In sum, the Commission devoted considerable attention in its 
rulemaking proceeding to the question whether it should retain the 
subsystem requirements of part 60 which would establish quantitative 
performance criteria for the geologic barriers but decided against this 
approach. Petitioner is dissatisfied with this outcome and essentially 
seeks reconsideration of this decision. However, petitioner has 
presented no significant new information to support this request and it 
would be an unwise expenditure of resources to cover this same ground 
again in a new rulemaking.\10\
---------------------------------------------------------------------------

    \10\ Petitioner cites a 1999 DOE analysis of the independent 
capabilities of the multiple waste isolation barriers which 
indicated that the engineered barriers contribute over 99.7 percent 
of the waste isolation capabilities of the repository system, 
implying that NRC will not really apply a ``multiple barrier'' 
approach because the geologic contributions of YM are minuscule. 
Petition at 27, n.16. But our rules on their face unequivocally 
require ``multiple barriers,'' as called for by NWPA. See 
discussion, supra. Our consideration of the nature of DOE's proposed 
facility must await a DOE license application.
---------------------------------------------------------------------------

Potentially Disqualifying Conditions
    NRC's generic Part 60 regulations contain siting criteria which 
include ``potentially adverse conditions'' which must be shown not to 
compromise the ability of the repository to meet the performance 
objectives for isolation of the wastes. See 10 CFR 60.122. Petitioner 
seeks to amend part 63 to include many of these potentially adverse 
conditions as ``potentially disqualifying conditions'' and to require 
the applicant to show that they do not exist or, if they do exist, 
``that they are

[[Page 9030]]

not materially adverse to the long-term safety of the repository.'' 
Petition at 41-43.
    In proposing part 63, the Commission specified overall performance 
objectives for the preclosure and postclosure phases of the repository 
and requirements that compliance with these overall performance 
objectives be demonstrated through an integrated safety analysis of 
preclosure operations, and through a performance assessment for long-
term, post-closure performance. The proposal did not specify 
potentially adverse conditions to be considered but did require that 
the performance assessment consider unfavorable, as well as favorable, 
information:

    A defensible performance assessment should contain a technical 
rationale for those features, events, and processes that have been 
included in the performance calculation, as well as those that have 
been considered but were excluded. The features, events, and 
processes (i.e., specific conditions or attributes of the geologic 
setting; degradation, deterioration, or alteration of the engineered 
barriers; and interactions between the natural and engineered 
barriers) conducted for inclusion in the assessment should represent 
a wide range of beneficial and detrimental effects on performance.

(64 FR 8650; February 22, 1999). Public comments on the proposed rule 
raised concerns about the impacts of certain features, events, and 
processes (e.g., that YM lies in an area that is seismically and 
tectonically active, that there may be potential for fast ground-water 
pathways to the water table) that prompted many commenters to recommend 
that YM be disqualified from further consideration. The Commission 
considered these objections but reaffirmed the approach it had decided 
to take in the proposed rule:

    Consideration of all FEPs, especially those with the potential 
to have an adverse effect on performance, is an important part of 
the evaluation of repository performance. Commenters have correctly 
identified a number of conditions that have been or are being 
considered by DOE in performance assessments for Yucca Mountain, 
such as seismic activity, thermal effects, volcanic activity, 
microbial-induced corrosion of the waste package, and the potential 
for a significant rise of the water table. Section 63.114 requires 
DOE to consider all FEPs pertinent to a repository at Yucca Mountain 
and fully justify how they are treated in the performance 
assessment. In reviewing DOE's performance assessment, the NRC will 
evaluate how well DOE has accounted for those FEPs that could have 
an adverse effect on the repository.

(66 FR 55748; November 2, 2001). Thus, the Commission considered in the 
part 63 rulemaking whether it should specify disqualifying conditions 
for the repository site, but decided that its approach of having the 
performance assessment present and consider all information relevant to 
negative conditions was preferable. The Commission finds no reason 
presented by petitioner to reopen that issue.
Peak Radiation Doses Subsequent to the Regulatory Monitoring Period
    Petitioner requests that Sec.  63.113 be amended to add the 
following provision:

    Peak Dose. The geologic setting for the Yucca Mountain 
repository shall evidence sufficient geologic suitability to provide 
reasonable assurance that peak radiation doses to the accessible 
environment will not occur subsequent to the regulatory monitoring 
period established by the Environmental Protection Agency in 40 CFR 
part 197.

Petition at 43. This requirement is purportedly needed because, in 
petitioner's view, ``the repository will become most dangerous to 
humans and the environment after the EPA's prescribed regulatory time 
period.'' Petition at 33 (emphasis in original). Petitioner supports 
this view with a graphic produced in the July 2002 National Geographic 
using data provided in DOE's Final Environmental Impact Statement, DOE/
EIS-0250 (February 2002). Petition, Attachment 2. According to 
petitioner, this graphic illustrates that ``DOE's own models predict 
that radiation doses from Yucca Mountain releases to the accessible 
environment will not begin to peak until after the 10,000-year 
regulatory time period that forms the basis for part 63 licensing.'' 
Petition at 33.
    Petitioner believes that NRC must have reasonable assurance that 
the peak radiation doses to the accessible environment will occur 
within the regulatory compliance period.\11\ This amounts to a 
challenge to the 10,000 year compliance period adopted by the 
Commission in Part 63. The Commission proposed a 10,000 year compliance 
period for evaluating a YM repository because it:

    \11\ We interpret petitioner's reference to ``the regulatory 
monitoring period established by the Environmental Protection Agency 
in 40 CFR 197'' to be a reference to the 10,000 year compliance 
period established in EPA's regulations. Those regulations do not 
include a monitoring period.

    (1) includes the period when the waste is inherently most 
hazardous; (2) is sufficiently long, such that a wide range of 
conditions will occur which will challenge the natural and the 
engineered barriers, providing a reasonable evaluation of the 
robustness of the geologic repository; and (3) is consistent with 
other regulations involving geologic disposal of long-lived 
---------------------------------------------------------------------------
hazardous materials, including radionuclides.

(64 FR 8647; February 22, 1999). The Commission acknowledged that, on 
this matter, it was not following the recommendation made by NAS that 
the compliance period should include the time when greatest risk 
occurs, within the limits imposed by the stability of the geologic 
system. However, the Commission explained:

    In selecting the length of time over which the individual dose 
limit should be applied, a regulatory agency must take into account 
technical, policy, and legal considerations. In fact, NAS noted that 
EPA might elect to establish consistent policies for managing 
comparable risks from disposal of long-lived hazardous materials. 
From a technical perspective, for example, the time-dependent 
variation of the hazard, along with the time required to evaluate 
adequately the waste isolation capability of both engineered and 
natural barriers, are of significance. From a policy perspective, on 
the other hand, the practical utility and relative uncertainty of 
extremely long projections of health consequences, along with the 
need to maintain a consistent regulatory approach for like hazards, 
need to be weighed. Having considered both technical and policy 
concerns, the Commission is proposing the use of 10,000 years for 
evaluating compliance with the system performance objective at Sec.  
63.113.

Id. The Commission received comments objecting to this proposal, but 
decided to reaffirm use of a 10,000 year compliance period in the final 
rule:

    The fact that it is feasible to calculate performance of the 
engineered and geologic barriers making up the repository system for 
periods much longer than 10,000 years does not mean that it is 
possible to make realistic or meaningful projections of human 
exposure and risk, attributable to releases from the repository, 
over comparable time frames. NAS acknowledged that projecting the 
behavior of human society over long periods is beyond the limits of 
scientific analysis and recommended that ``cautious, but 
reasonable'' assumptions, based upon current knowledge, be made with 
regard to the selection of biosphere and critical group parameters 
for Yucca Mountain. Determining just how far into the future current 
knowledge can no longer support ``reasonable'' assumptions about 
pathways affecting human exposure is clearly a subjective, policy 
judgment. NRC believes that, for periods approaching 1,000,000 
years, as suggested by NAS, during which significant climatic and 
even human evolution would almost certainly occur, it is all but 
impossible to make useful and informed assumptions about human 
behaviors and exposure pathways.

(66 FR 55760; November 2, 2001).
    Thus, the Commission has considered the appropriate length of the 
compliance period and has determined that 10,000 years is an acceptable 
period for assessing compliance with performance standards. The

[[Page 9031]]

Commission also adopted an EPA standard requiring DOE to calculate the 
peak dose of the reasonably maximally exposed individual that would 
occur after 10,000 years following disposal, but did not apply a 
regulatory standard to the results of this analysis. Instead, DOE is to 
include the results of the analyses and their bases in the 
environmental impact statement for YM as an indicator of long-term 
disposal system performance. See 10 CFR 63.341; see also 40 CFR 197.35. 
The Commission continues to believe, as articulated in the both the 
proposed and final regulations, that potential radiation exposures 
estimated at very long times into the future (e.g., 100,000 years and 
longer), such as those shown in the National Geographic graphic, are 
too speculative to provide meaningful information to make licensing 
decisions.
Need for Presentation of an Affirmative Safety Case
    Petitioner believes that DOE must be required to present ``an 
affirmative safety case'' which demonstrates an understanding of 
repository performance. To ensure demonstration of an affirmative 
safety case, petitioner has proposed a new regulation (proposed Sec.  
63.21(c), supra) which is based on, but not identical to, 
recommendations made by the Peer Review with respect to DOE's TSPA-
SR.\12\ Although the Peer Review focused on DOE's TSPA-SR, it did make 
a few observations on NRC's proposed part 63:
---------------------------------------------------------------------------

    \12\ The Peer Review expressed the view that the TSPA-SR could 
be improved with respect to developing a better understanding of the 
repository system:

    The regulations require that a risk-informed approach should be 
adopted in demonstrating compliance with the dose limit, in 
recognition of the uncertainties inherent in making assessments over 
long time frames in the future. It is also required that the 
assessment should reveal an understanding of the relationship 
between the performance of the repository sub-systems and the total 
system performance. Nevertheless despite the prescriptive nature of 
the regulations, the I[nternational] R[eview] T[eam] notes that the 
proposed licensing regulation 10 CFR 63 states that ``consistent 
with a performance based philosophy, the Commission proposes to 
permit DOE the flexibility to select the approach for demonstrating 
this relationship that is most appropriate to its analysis.''
    The TSPA-SR methodology embodies a comprehensive computational 
framework for estimating possible doses to future generations using 
a complex systems-level model accounting for hundreds of features, 
events and processes and related parameter ranges. A key issue with 
this approach is the difficulty in understanding the meaning of the 
numerical results. In particular, it is often difficult to 
understand how the system is likely to evolve and which process and 
parameters are the most important.
Peer Review at 41.
    In its review of the TSPA-SR, the IRT has observed a tendency 
for more focus to be given to the demonstration of numerical 
compliance with the proposed regulatory requirements than on 
developing and presenting an understanding of repository 
performance. Whilst it is completely understandable that the TSPA-SR 
should give due attention to demonstrating compliance with the 
prescribed dose limit, an in-depth understanding of the performance 
of the repository system is necessary to develop confidence in the 
overall design and safety of the repository and in the results of 
the assessment. In this regard, there is an emerging international 
consensus that building confidence in repository performance is of 
comparable importance to demonstrating compliance with criteria. 
Thus it is recommended that in the future equal attention should be 
given to system understanding as to numerical compliance with 
regulatory criteria if the project proceeds to the licensing stage.

Peer Review at 23-24 (emphasis in original).
    Thus, the Peer Review acknowledged the importance of DOE 
presenting, in its TSPA, an in-depth understanding of the performance 
of the repository system and recognized that demonstration of safety is 
more than numerical compliance with the proposed regulatory 
requirements. As a matter of record, a similar concern was raised 
during the public comment period on the proposed regulation (i.e., can 
performance assessment be relied on as the sole quantitative technique 
for evaluating compliance with the postclosure safety requirements). 
The Commission, in response to this concern, explained that the 
regulations contained a number of requirements directed at DOE's 
demonstrating an in-depth understanding of the repository system:

    Although repository postclosure performance is evaluated with 
respect to a single performance measure for individual protection, 
the NRC considers a broad range of information in arriving at a 
licensing decision. In the case of the proposed repository at Yucca 
Mountain, Part 63 contains a number of requirements (e.g., 
qualitative requirements for data and other information, the 
consideration and treatment of uncertainties, the demonstration of 
multiple barriers, performance confirmation program, and QA program) 
designed to increase confidence that the postclosure performance 
objective is satisfied. The Commission will rely on the performance 
assessment as well as DOE's compliance with these other requirements 
in making a decision, if DOE submits a license application for 
disposal of HLW at Yucca Mountain.

(66 FR 55746; November 2, 2001).
    The current regulations require that DOE provide an adequate and 
appropriate understanding of the repository system as part of its 
compliance demonstration. For example, the requirements for the 
performance assessment, at 10 CFR 63.114, specify that DOE must account 
for uncertainty in representing the repository system (both in 
parameters and models); provide a technical basis for either inclusion 
or exclusion of specific features, events, and processes in the 
performance assessment including the degradation, deterioration, or 
alteration processes of engineered and geologic barriers; and provide a 
technical basis for the models used in the performance assessment such 
as comparisons made with outputs of detailed process-level models and/
or empirical observations (e.g., laboratory testing, field 
investigations, and natural analogs). Additionally, the requirements 
for multiple barriers, at 10 CFR 63.115, specify that DOE must identify 
those design features of the engineered barrier system, and natural 
features of the geologic setting, that are considered barriers 
important to waste isolation; describe the capability of barriers 
identified as important to waste isolation actually to isolate waste, 
taking into account uncertainties in characterizing and modeling the 
behavior of the barriers; and provide the technical basis for the 
description of the capability of barriers.
    In summary, the current regulations require that DOE: demonstrate 
an adequate and appropriate understanding of the repository system, 
supported by technical and scientific information that includes a range 
of important technical concerns, such as the features, events, and 
processes that could affect the performance of the repository; provide 
an evaluation of how uncertainty in parameters and models affects the 
estimates of repository performance; and show the capabilities of the 
engineered and geologic barriers to isolate waste.
    Petitioner had full opportunity during the extensive Part 63 
rulemaking to suggest additional requirements for DOE's application to 
provide greater understanding of the repository system, and did so in 
its comments questioning the appropriateness of the Commission's 
proposal to establish risk-informed and performance based regulations 
which would not include the existing sub-system performance 
requirements of Part 60. The Peer Review, although published after 
NRC's issuance of the final rule, is based on information widely 
available during NRC's rulemaking proceeding (e.g., U.S. NRC

[[Page 9032]]

Advisory Committee on Nuclear Waste Letter to Chairman Jackson, dated 
April 8, 1999, ``SR 95 Template for Safety Reports with Descriptive 
Example,'' Swedish Nuclear Power Inspectorate, Technical Report 96-05). 
Thus, the Peer Review did not present new information with respect to 
Part 63; it presented a critique of DOE's TSPA-SR. Consequently, we do 
not believe that the Peer Review, or other critiques of DOE's 
activities at YM, justifies expending the resources that would be 
needed to reopen the issues considered in the recent part 63 
rulemaking.
    For all the reasons stated above, the NRC denies the petition in 
its entirety.

    Dated at Rockville, Maryland, this 21st day of February, 2003.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 03-4625 Filed 2-26-03; 8:45 am]
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