[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]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
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.
========================================================================
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[[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]
BILLING CODE 7590-01-P