[Federal Register Volume 64, Number 34 (Monday, February 22, 1999)]
[Proposed Rules]
[Pages 8640-8679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4022]
[[Page 8639]]
_______________________________________________________________________
Part II
Nuclear Regulatory Commission
_______________________________________________________________________
10 CFR Part 19 et al.
Disposal of High-Level Radioactive Wastes in a Proposed Geological
Repository at Yucca Mountain, Nevada; Proposed Rule
Federal Register / Vol. 64, No. 34 / Monday, February 22, 1999 /
Proposed Rules
[[Page 8640]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 2, 19, 20, 21, 30, 40, 51, 60, 61, and 63
RIN 3150-AG04
Disposal of High-Level Radioactive Wastes in a Proposed Geologic
Repository at Yucca Mountain, Nevada
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing
licensing criteria for disposal of spent nuclear fuel and high-level
radioactive wastes in the proposed geologic repository at Yucca
Mountain, Nevada. These criteria will address the performance of the
repository system at Yucca Mountain, a system that must comprise both
natural and engineered barriers. The proposed requirements are designed
to implement a health-based, safety objective for long-term repository
performance that is fully protective of the public health and safety,
and the environment, and is consistent with national and international
recommendations for radiation protection standards. Also included are
licensing procedures, criteria for public participation, records and
reporting, monitoring and testing programs, performance confirmation,
quality assurance, personnel training and certification, and emergency
planning. The proposed criteria will apply specifically and exclusively
to the proposed repository at Yucca Mountain. Consistent with this
intent, the Commission proposes to modify its generic criteria for
disposal of spent nuclear fuel and high-level radioactive wastes in
geologic repositories at 10 CFR Part 60 to make clear that they do not
apply, nor may they be the subject of litigation, in any NRC licensing
proceeding for a repository at Yucca Mountain.
DATES: Submit comments by May 30, 1999. Comments received after this
date will be considered if it is practical to do so, but the NRC is
able to assure consideration only for comments received on or before
this date.
ADDRESSES: Comments may be sent by mail to the Secretary, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, Attention:
Rulemakings and Adjudications Staff.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland,
between 7:30 am and 4:15 pm on Federal workdays.
You may also provide comments via the NRC's interactive rulemaking
web site through the NRC home page (http://www.nrc.gov). This site
provides the availability to upload comments as files (any format), if
your web browser supports that function. For information about the
interactive rulemaking site, contact Ms. Carol Gallagher (301) 415-
5905; e-mail [email protected]
Certain documents related to this rulemaking, including comments
received and the regulatory analysis, may be examined at the NRC Public
Document Room, 2120 L Street NW. (Lower Level), Washington, DC. These
same documents also may be viewed and downloaded electronically via the
interactive rulemaking website established by NRC for this rulemaking.
FOR FURTHER INFORMATION CONTACT: Timothy McCartin, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone (301) 415-6681; e-mail
tjm3@nrc.gov, or Clark Prichard, Office of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone (301) 415-6203; e-mail cwp@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
II. NAS Conclusion and Recommendations for Yucca Mountain
III. Development of a New 10 CFR Part 63
IV. Part 63 Technical Criteria
V. Individual Protection Standard for Postclosure Repository
Performance
VI. Reference Biosphere and Critical Group for Yucca Mountain
VII. Compliance Period
VIII. Multiple Barriers and Defense in Depth
IX. Performance Assessment
X. Institutional Controls
XI. Human Intrusion
XII. Preclosure Performance Objective
XIII. Integrated Safety Analysis of Activities at the Geologic
Repository Operations Area
XIV. Quality Assurance
XV. Emergency Planning
XVI. Changes, Tests and Experiments
XVII. Relationship to Generic Criteria at Part 60
XVIII. Section-by-Section Analysis of Part 63
XIX. Section-by Section Analysis of Changes to Other Parts
XX. Specific Questions for Public Comment
XXI. Plain Language
XXII. Finding of No Significant Environmental Impact: Availability
XXIII. Paperwork Reduction Act Statement
XXIV. Regulatory Analysis
XXV. Regulatory Flexibility Certification
XXVI. Backfit Statement
I. Background
The Nuclear Waste Policy Act of 1982 (NWPA, Public Law 97-425)
directed NRC to develop technical criteria for high-level radioactive
waste (HLW) disposal, in mined geologic repositories, that: provide for
the use of a system of multiple barriers; include restrictions on
retrievability, as the Commission deems appropriate; and are not
inconsistent with environmental standards promulgated by the
Environmental Protection Agency (EPA) pursuant to the NWPA. Existing
NRC regulations at 10 CFR Part 60 contain generic criteria governing
the licensing of the Department of Energy (DOE) to receive and possess
source, special nuclear, and byproduct material at a geologic
repository that is sited, constructed, and operated in accordance with
NWPA. Procedural requirements at Part 60 were promulgated in 1981 (46
FR 13971; February 25, 1981), and technical criteria were promulgated
in 1983 (48 FR 28194; June 21, 1983). These technical criteria were
amended in 1985 to add specific criteria for disposal in the
unsaturated zone (50 FR 29641; July 22, 1985). Procedural amendments
reflecting the passage of the NWPA were published in 1986 (51 FR 27158;
July 30, 1986), and procedures for implementation of the National
Environmental Policy Act with respect to geologic repositories for HLW
were added in 1989 (54 FR 27864; July 3, 1989). In 1996, NRC amended
Part 60 to update generic criteria for preclosure activities at
repository sites (61 FR 64267; December 4, 1996), incorporating changes
that sought, in part, to achieve greater consistency between those
criteria and the NRC's licensing requirements for independent storage
of spent fuel and HLW at 10 CFR Part 72.
The technical criteria at Part 60 were promulgated initially, in
1983, on the assumption that EPA would issue standards limiting
cumulative radionuclide releases from a geologic repository. In 1985,
some 2 years after Part 60 was published, EPA issued final standards at
40 CFR Part 191, which contained not only cumulative release limits but
also provided criteria for individual and ground-water protection, that
had not been included in EPA's rulemaking proposal. In 1986, NRC
proposed ``conforming amendments'' to incorporate the EPA standards
into NRC's regulations (51 FR 22288; June 19, 1986). The proposed
amendments were abandoned in 1987 when EPA's standards were vacated by
the U.S. Court of Appeals. Also, in 1987, Congress amended NWPA,
redirecting the national waste program to focus exclusively on the
characterization of the Yucca Mountain site as a potential geologic
repository.
During the more than 15 years since the initial technical criteria
at 10 CFR
[[Page 8641]]
Part 60 were promulgated, there has been considerable evolution in the
capability of technical methods for assessing the performance of a
geologic repository at Yucca Mountain (``TPA 3.1-Sensitivity and
Uncertainty Analyses,'' NUREG/CR-5549, in publication; ``Total System
Performance Assessment--1995: An Evaluation of the Potential Yucca
Mountain Repository,'' DOE, 1995). These changes allow for the use of
more effective and efficient methods of analysis for evaluating
conditions at Yucca Mountain than do NRC's existing generic criteria.
These new methods were not envisioned when the Part 60 criteria were
established, and their implementation for Yucca Mountain will 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.
In 1992, Congress directed EPA, at Section 801 of the Energy Policy
Act of 1992, Public Law 102-486 (EnPA), to contract with the National
Academy of Sciences (NAS) to advise EPA on the appropriate technical
basis for public health and safety standards governing the Yucca
Mountain repository. On August 1, 1995, the NAS Committee on Technical
Bases for Yucca Mountain Standards issued its report, ``Technical Bases
for Yucca Mountain Standards.'' In its report, NAS recommended an
approach and content that is significantly different from that adopted
by EPA for its disposal standards at 40 CFR 191 (no longer applicable
to sites characterized under Section 113(a) of NWPA), as well as from
that adopted by NRC for its existing generic regulations at Part 60.
EPA is obligated, under EnPA, to issue final public health and
safety standards for Yucca Mountain that ``prescribe the maximum annual
effective dose equivalent to individual members of the public'' and
that are ``based upon and consistent with'' the NAS findings and
recommendations. According to EnPA, EPA's new health-based disposal
standards ``* * * shall be the only such standards applicable to the
Yucca Mountain site.'' After establishment of final EPA standards, NRC,
under EnPA, has 1 year to modify its technical requirements and
criteria under Section 121(b) of the NWPA (i.e., the current Part 60
criteria) to be consistent with new EPA standards, and also to
implement certain assumptions that are specified in the EnPA with
regard to the effectiveness of postclosure oversight of the repository,
to the extent consistent with the NAS report. Following repository
closure, EnPA requires that DOE continue its oversight of the Yucca
Mountain site to ``prevent any activity at the site that poses an
unreasonable risk of--(1) breaching the repository's engineered or
geologic barriers; or (2) increasing the exposure of individual members
of the public to radiation beyond allowable limits.'' NRC's
requirements and criteria are to assume, consistent with the findings
and recommendations of NAS, that such oversight will be effective.
Because NRC must carry out a rulemaking to modify its requirements
for geologic repository disposal within a very short period of time
following EPA publication of final standards for Yucca Mountain, the
Commission believes it must undertake its own rulemaking development in
parallel with development of EPA's standards. Following publication of
the NAS report, NRC staff met frequently with EPA staff to discuss the
report and associated issues relating to development of new EPA
standards and NRC regulations. NRC is continuing to work with EPA in
the development of reasonable and implementable standards for Yucca
Mountain that are protective of public health and safety. The
Commission believes, as noted below, that it is in the best interest of
the national program to proceed with promulgation of its implementing
regulations. It is recognized that when EPA issues its final standards,
or if new legislation affecting the regulation of the Nation's HLW
program is enacted into law, these proposed regulations may need to be
amended.
At the same time, the DOE program for characterizing the Yucca
Mountain site as a potential geologic repository is continuing. A
viability assessment of the site was completed in December 1998.
Further, it is expected that DOE will publish a draft environmental
impact statement (EIS) in 1999, with a final EIS to be completed in
2000, such that a site suitability recommendation can be made in 2001.
Assuming that the Yucca Mountain site can be recommended for
development as a geologic repository, DOE would then submit a license
application to NRC in 2002.
In order for DOE to commence preparation of a license application
and to permit timely and significant public involvement in the
development of implementing regulations, the Commission believes it has
an obligation to make public now how it would implement dose- or risk-
based standards for Yucca Mountain.
As part of its broader efforts to improve the effectiveness of its
programs and processes, the Commission has a study of the NRC hearing
process underway which includes the process that would be used for
repository licensing. If, on the basis of this study, the Commission
concludes that changes to the hearing process are warranted, it will
propose them for adoption in a separate notice and comment rulemaking.
In this rulemaking, the Commission is not seeking comment on potential
changes to the hearing process. However, in the interest of openness,
the Commission wishes to say that, at present, the Commission is
inclined to provide for informal hearings for both construction
authorization and licensing to receive and possess waste. No statute
requires formal hearings in either case; EPA conducted none in
certifying the Waste Isolation Pilot Project; and informal hearings
allow for both greater efficiency and greater openness.
II. NAS Conclusions and Recommendations for Yucca Mountain
Pursuant to Section 801(a)(2) of EnPA, the NAS was directed to
provide recommendations on reasonable standards for a repository at
Yucca Mountain that address the following three issues:
(A) Whether a health-based standard, based on doses to individual
members of the public, from releases to the accessible environment,
will provide a reasonable standard for protection of the health and
safety of the general public;
(B) Whether it is reasonable to assume that a system for
postclosure oversight of the repository can be developed, based on
active institutional controls, that will prevent an unreasonable risk
of breaching the repository's engineered or geologic barriers or
increasing the exposure of individual members of the public to
radiation beyond allowable limits; and
(C) Whether it is possible to make scientifically supportable
predictions of the probability that the repository's engineered or
geologic barriers will be breached as a result of human intrusion, over
a period of 10,000 years.
On August 1, 1995, NAS published its report entitled ``Technical
Bases for Yucca Mountain Standards.'' The report was prepared by a
committee organized under the auspices of the National Research
Council, which is jointly managed by the National Academy of Sciences
and the National Academy of Engineering. The committee, consisting of
15 members representing engineering, geoscience, environmental, and
risk disciplines, deliberated for more than 2 years, holding five
public sessions in Las Vegas, Nevada, and Washington, DC, between May
1993 and April 1994.
[[Page 8642]]
With regard to the three questions posed in the EnPA, the NAS made
the following findings:
(A) That an individual protection standard, expressed as a limit on
individual risk rather than dose, would provide a reasonable basis for
protecting the health and safety of the general public provided that
the policy makers and the public are prepared to accept that very low
radiation doses pose a negligibly small risk. Further, NAS found that
such a standard would be particularly appropriate for the Yucca
Mountain site in light of the characteristics of the site.
(B) That it is not reasonable to assume that a system for post-
closure oversight of the repository can be developed, based on active
institutional controls, that will prevent an unreasonable risk of
breaching the repository's engineered barriers or increasing the
exposure of individual members of the public to radiation beyond
allowable limits.
(C) That it is not possible to make scientifically supportable
predictions of the probability that a repository's engineered or
geologic barriers will be breached as a result of human intrusion over
a period of 10,000 years.
The specific conclusions and recommendations delineated in the
Executive Summary of the NAS report (pp. 1 through 14) were:
(1) The standard should set ``* * *a limit on the risk to
individuals of adverse health effects from releases from the
repository.'' NAS explicitly recommended against quantitative release
limits because they provide no additional protection relative to that
provided by an individual risk limit. NAS declined to assign the
appropriate level of risk, and stated that it views the determination
of this level as a crucial policy judgment that should be addressed in
a transparent rulemaking process. As a starting point in such a
process, NAS suggested that consideration be given to risk levels
comparable to those recommended by the International Commission on
Radiological Protection (ICRP) (100 mrem/yr (1 mSv/yr) maximum
individual dose from all sources, with 10-30 mrem/yr (0.1-0.3 mSv/yr)
allocated for high-level waste disposal) (p. 4).
(2) For specifying the individual or individuals for whom the risk
calculation is to be made, the NAS recommended that the critical-group
approach, as defined by ICRP and modified for individual risk, should
be used. The ICRP notes that the critical group concept is intended to
ensure that no individual doses are unacceptably high, since the
critical group represents the extreme of the dose distribution to the
entire population. The critical group risk calculated for comparison
with the risk limit established in the standard, according to NAS,
should be the mean of the risks to the members of a group whose
location and habits are such that they are representative of those
individuals expected to receive the highest doses as a result of the
discharges of radionuclides. For releases expected to occur in the far
future, it will be necessary to define a hypothetical group of
individuals by making assumptions about lifestyle, location, eating
habits, and other factors. NAS cited the ICRP recommendation that
present knowledge and cautious, but reasonable, assumptions be used in
defining this group of individuals (pp. 5-6).
(3) NAS recommended that compliance assessment should be conducted
over a time frame that includes the period where greatest risk occurs.
NAS found there to be no scientific basis for limiting the time period
of an individual-risk standard (pp. 6-7).
(4) In response to issue (A) specified at Section 801(a)(2) of
EnPA, NAS concluded that ``* * * an individual-risk standard would
protect public health, given the particular characteristics of the
[Yucca Mountain] site, provided that policy makers and the public are
prepared to accept that very low radiation doses pose a negligibly
small risk.'' As a suitable starting point for a determination of
negligible individual risk, NAS suggested that consideration should be
given to the risk equivalent of 1 mrem per year (0.01 mSv per year) as
recommended by the National Council on Radiation Protection (pp. 7-8).
(5) NAS concluded that physical and geologic processes affecting
Yucca Mountain ``* * * are sufficiently quantifiable and the associated
uncertainties sufficiently boundable such that performance can be
assessed over time frames during which the geological system is
relatively stable or varies in a boundable manner.'' According to NAS,
the geologic record suggests this time frame is on the order of a
million years (p. 9).
(6) NAS concluded that it is not possible to predict on the basis
of scientific analyses the societal factors necessary to define
exposure scenarios, and that specification of such scenarios is a
policy judgment best accomplished through a public rulemaking process
(pp. 9-10).
(7) In response to issue (B) as specified at Section 801(a)(2) of
EnPA, NAS concluded that ``* * * it is not reasonable to assume that a
system for postclosure oversight, based on active institutional
controls, can be developed that will prevent an unreasonable risk of
breaching the repository's engineered barriers or increasing the
exposure of individual members of the public to radiation beyond
allowable limits.'' Despite its conclusion that there exists no
scientific basis for judging whether such controls can prevent an
unreasonable risk of intrusion, NAS, nonetheless, asserts that ``a
collection of prescriptive requirements, including active institutional
controls, record-keeping, and passive barriers and markers, would help
to reduce the risk of human intrusion, at least in the near term'' (p.
11).
(8) With regard to issue (C) as specified at Section 801(a)(2) of
EnPA, NAS concluded that it is not possible to make scientifically
supportable predictions of the probability that the repository's
engineered or geologic barriers will be breached as a result of human
intrusion over a period of 10,000 years. Because NAS could not find it
technically feasible to assess the probability of intrusion into a
repository over the long term, NAS concluded that it is not
scientifically justified to incorporate alternative scenarios of human
intrusion into a fully risk-based compliance assessment (p. 11).
(9) In order to assess whether the repository's performance would
be substantially degraded as a consequence of a postulated intrusion,
NAS considered a ``stylized intrusion scenario consisting of one
borehole of a specified diameter drilled from the surface through a
canister of waste to the underlying aquifer.'' NAS recommended that
``the estimated risk calculated from the assumption of such an assumed
scenario be no greater than the risk limit adopted for the undisturbed-
repository case because a repository that is suitable for safe long-
term disposal should be able to continue to provide acceptable waste
isolation after some type of intrusion'' (p. 12).
(10) NAS concluded that ``there is no scientific basis for
incorporating the ALARA [as low as is reasonably achievable] principle
into the EPA standard or USNRC regulations for the repository'' (p.
13).
(11) NAS concluded that ``because it is the performance of the
total system in light of the risk-based standard that is crucial,
imposing subsystem performance requirements might result in suboptimal
design.'' This conclusion was directed specifically to NRC, in the
context of revisions NRC will need to make to its regulations in order
to be consistent with a new risk-based EPA
[[Page 8643]]
standard for Yucca Mountain. NRC's existing generic regulations at 10
CFR Part 60 currently contain quantitative limits on the performance of
specific subsystems such as those cautioned against by NAS.
III. Development of a New 10 CFR Part 63
As discussed above, the Commission is directed by EnPA to modify
its requirements for geologic disposal within a very short time to
implement site-specific standards for Yucca Mountain. The legislation
also specifies the type of standards NRC is to implement (i.e.,
standards which limit individual dose, and which are based on and
consistent with the NAS recommendations). In view of these constraints,
the Commission is proposing to establish a new, separate part of its
regulations at 10 CFR Part 63 that will apply only to the proposed
repository at Yucca Mountain. The Commission is also proposing to leave
its existing, generic regulations at 10 CFR Part 60 in place, modified
only to indicate that they do not apply, nor may they be the subject of
litigation, in any NRC licensing proceeding for a repository at Yucca
Mountain. The Commission believes this to be the most direct and time-
efficient approach to the specification of concise, site specific
criteria for Yucca Mountain that are consistent with current
assumptions, with site-specific information and performance assessment
experience, and with forthcoming EPA standards that must also apply
solely to Yucca Mountain.
In establishing these criteria, the Commission seeks to establish a
coherent body of risk-informed, performance-based criteria for Yucca
Mountain that is compatible with the Commission's overall philosophy of
risk-informed, performance-based regulation. Stated succinctly, risk-
informed, performance-based regulation is an approach in which risk
insights, engineering analysis and judgment (e.g., defense in depth),
and performance history are used to (1) focus attention on the most
important activities, (2) establish objective criteria for evaluating
performance, (3) develop measurable or calculable parameters for
monitoring system and licensee performance, (4) provide flexibility to
determine how to meet the established performance criteria in a way
that will encourage and reward improved outcomes, and (5) focus on the
results as the primary basis for regulatory decision-making. The
Commission believes that the creation of a new part of its regulations
to accomplish these objectives 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.
The Commission proposes to leave the existing generic requirements
intact and in place, if needed, for sites other than Yucca Mountain.
Although their application could be expected to be difficult, the
Commission assumes that it would be afforded adequate time and
resources in future years to amend its generic regulations for any
additional repository site that might be authorized. Other alternatives
to this approach have been considered but rejected. The Commission
could defer development of proposed regulations until final EPA
standards for Yucca Mountain are in place, thereby making it easier for
the Commission to conform its regulations to established standards.
However, the time schedule for development of the Yucca Mountain
repository is aggressive, and DOE has stated that it needs to have
implementing regulations in place by 2000. Only by initiating
development of these regulations now can this milestone be met.
Although the Commission may not know all the details of EPA's final
standards at this time, the NAS recommendations with which EPA must be
consistent have been public for more than 3 years.
Other options for revising NRC's generic criteria at Part 60, in
addition to developing new site-specific standards for Yucca Mountain,
were also considered but rejected: (1) creation of a new part for Yucca
Mountain while simultaneously updating Part 60, and (2) updating Part
60 in such a way as to include a site-specific subpart for Yucca
Mountain. Simultaneously revising generic criteria and developing Yucca
Mountain-specific criteria would require more resources than the
Commission has available at this time. Furthermore, the Commission can
identify no foreseeable need for revised generic requirements and
criteria because, among other things, no site other than Yucca Mountain
is undergoing characterization as a HLW repository.
IV. Part 63 Technical Criteria
The foundation for the Commission's proposed technical criteria at
10 CFR Part 63 is the specification of overall performance objectives
for 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,
postclosure performance. This risk-informed, performance-based approach
does not include specification of design and siting criteria or
quantitative subsystem requirements; however, the Commission is
proposing specific requirements for the content of the assessments to
ensure their adequacy and the sufficiency of the information provided
to the Commission. The Commission believes that its proposed approach
ensures protection of public health and safety and provides appropriate
flexibility to DOE for demonstrating compliance, while ensuring that
the information required to make a licensing decision will be provided
to the Commission. The Commission's consideration of specific topics
related to the proposed technical criteria is elaborated further in
subsequent sections of this notice.
V. Individual Protection Standard for Postclosure Repository
Performance
As already stated, the authority and responsibility for setting
public health and safety standards for radioactive waste disposal at
Yucca Mountain rest with EPA. It is NRC's responsibility to implement
those standards in its licensing actions and ensure that public health
and safety are protected. The Commission is proposing an individual
dose limit which it believes is generally consistent with EnPA and with
the conclusions and recommendations of NAS. Although EnPA required that
EPA specify a limit based on individual dose, NAS recommended a limit
be established on risk to individuals (i.e., the probability that an
individual or individuals receive an adverse health effect). An
equivalent level of radiation protection is afforded individuals by a
standard expressed either as a risk or a dose limit when the evaluation
of dose or risk considers the probability of incurring a dose and both
limits are based on similar dosimetry assumptions (i.e., consistent
dose to health effects conversion). In previous rulemakings, the
Commission has used either implicitly or explicitly a constant total
effective dose equivalent to health risk
[[Page 8644]]
coefficient (i.e., FR 39061; July 21, 1997), and thus, for a given
probability of occurrence, the health risk can be related to a unique
value of dose. Additionally, the Commission is proposing an individual
dose limit because the Commission believes that a dose limit may be
more readily understood by the public and is the form of a standard
more frequently used to regulate nuclear activities. When EPA issues
final standards for Yucca Mountain or if new HLW legislation is enacted
into law, the Commission will amend its criteria at 10 CFR Part 63, if
necessary, to be consistent with the final standards. As a licensed,
operating facility, a repository at Yucca Mountain would be subject to
the existing regulations at 10 CFR Part 20 that require, among other
things, doses to members of the general public to not exceed a total
effective dose equivalent of (TEDE) 1 mSv (100 mrem) per year exclusive
of the dose contribution from background radiation, medical procedures,
and sanitary sewerage disposals. In addition, prior to permanent
closure, repository operations would need to be conducted such that
public exposures be maintained as low as reasonably achievable. When
the repository is closed, surface facilities must be decommissioned in
accordance with 10 CFR Part 20, Subpart E. Finally, during normal
operations and anticipated operational occurrences, the annual dose to
any real member of the public, located beyond the boundary of the site,
shall not exceed a TEDE of 0.25 mSv (25 mrem). This final dose limit,
used in this regulation, is adapted from the dose limits specified in
10 CFR Part 72,1 for effluents and direct radiation during
normal operations and anticipated operational occurrences, associated
with a monitored retrievable storage installation (MRS). Like an MRS
facility, the operations area at Yucca Mountain is expected to be a
large industrial facility equipped to handle the loading, unloading,
and decontamination of spent fuel and HLW shipping casks; the removal
and packaging or repackaging of spent fuel assemblies and HLW
canisters; and the sealing, handling, transport, stowage and periodic
monitoring of canisters to contain the spent fuel and HLW during
operations. Because the activities contemplated for the operations area
prior to repository closure pose similar radiological hazards, during
normal operations and anticipated operational occurrences, to those
posed at an operating MRS, the Commission is proposing that the dose
limits for the operations area be comparable to those applicable for
the MRS, from planned discharges and from direct radiation during
operations. (Radiation from other fuel cycle operations, anticipated
for an MRS or independent spent fuel installation (ISFSI) that might be
co-located with other operating nuclear facilities, is not anticipated
at the operations area, because fuel cycle operations are not likely to
be located in the region). The 0.25 mSv (25 mrem) limit also provides
consistency with requirements for other waste management facilities
(e.g., 40 CFR 191.03(a), 10 CFR 72.104, and 10 CFR 61.40) and for
license termination (10 CFR 20.1402). The protection standard is
consistent with the national and international recommendations for
radiation protection (National Council on Radiation Protection and
Measurements and International Commission on Radiological Protection).
The final dose limit used in this regulation and the requirement in 10
CFR 20.1101(b) to maintain doses to members of the public that are as
low as is reasonably achievable (ALARA) will fully protect the public
and the environment.
---------------------------------------------------------------------------
\1\ As a matter of policy, NRC considers 0.25 mSv (25 mrem) TEDE
as the appropriate dose limit within the range of potential doses
represented by the current 10 CFR 72.104 limit of 0.25 mSv (25 mrem)
(whole body), 0.75 mSv (75 mrem) (thyroid dose), and 0.25 mSv (25
mrem) (to any other critical organ). It is also important to note
that the average individual exposure in the U.S. from natural
background is approximately 3 mSv (300 mrem) per year or 3 times the
Part 20 public dose limit and 12 times the standard proposed for
Yucca Mountain.
---------------------------------------------------------------------------
To identify an appropriate objective for repository performance
after permanent closure, the Commission seeks to establish a constraint
that, if met, would provide reasonable assurance that doses to members
of the general public will remain below acceptable levels.
International guidance on dose limits suggests establishing constraint
limits for specific sources (such as a HLW repository) to ensure that
exposure to members of the public from all sources, excluding
background radiation, is less than the public dose limit. In the case
of operational releases, compliance with the requirements of 10 CFR
Part 20 can be expected, based on Commission experience with its other
licensed facilities, to limit effluents far below the public annual
dose limit of 1 mSv (100 mrem). For postclosure exposures, the
performance of the repository must depend on passive systems limiting
the exposure. Therefore, the performance objective for postclosure must
be established such that the public would not receive doses, from all
possible sources, excluding background radiation, in excess of 1 mSv
(100 mrem) per year.
The Commission proposes a limit of 0.25 mSv (25 mrem) to the total
effective dose equivalent, received in a single year and weighted by
the probability of occurrence, by the average member of the critical
group, as the overall system performance objective for the repository,
following permanent closure. This criterion would limit the dose
received from all possible pathways to the critical group at Yucca
Mountain, including direct exposure, drinking of contaminated water,
eating food that was irrigated with contaminated groundwater or grown
in contaminated soil, exposure to airborne releases, etc. The
Commission believes that application of a single, all-pathway standard
is protective of public health and safety, and obviates the need for
separate, single pathway limits. The Commission established the 0.25
mSv (25 mrem) annual dose limit as the overall safety objective for
both decommissioning of nuclear facilities (10 CFR 20.1402) and for
low-level radioactive waste disposal facilities (10 CFR 61.41). It is
within the range of international constraints that allocate doses from
high level waste disposal to between 0.1 and 0.3 mSv (10 and 30 mrem)
per year, and is comparable to the risk range recommended by NAS as a
reasonable starting point for EPA's rulemaking (a risk range of between
10 -5 and 10 -6 per year, approximately
equivalent to annual doses between 0.02 and 0.2 mSv (2 and 20 mrem)).
The Commission believes that 0.25 mSv (25 mrem) per year is
sufficiently below the public dose limit that no members of the public
near Yucca Mountain would be expected to receive doses from all
sources, excluding background radiation, in excess of 1 mSv (100 mrem)
per year. Estimates of potential exposures at Yucca Mountain are
expected to be probabilistic because these estimates will consider
variability and uncertainty in the features and processes, and a range
of events each with specific probability of occurrence over the time
period of interest at the site. The Commission proposes that an
expected annual dose, based on the probabilistic results, is
representative of individual risk and would be compared to the
individual protection standard for determining compliance. Calculation
of the expected annual dose incorporates the probability that the
estimated dose will occur (i.e., annual dose estimates consider the
probability of the occurrence of the events and the
[[Page 8645]]
uncertainty and variability of the parameter values used to describe
the behavior of the geologic repository).
VI. Reference Biosphere and Critical Group for Yucca Mountain
In addition to establishing an individual protection limit as an
overall system performance objective, as discussed above, it is
necessary to specify the individual or individuals for whom the
performance calculation is to be made, as well as the environment in
which the individual(s) reside, and the relevant pathways for potential
exposure. In this regard, the NAS observed that the appropriate
objective should be to ``protect the vast majority of members of the
public while also ensuring that the decision on the acceptability of a
repository is not prejudiced by the risks imposed on a very small
number of individuals with unusual habits or sensitivities.'' NAS
recommended that the characteristics of the critical group and
reference biosphere be defined in regulation. Citing guidance of ICRP,
NAS recommended the critical group be representative of those
individuals in the population expected to receive the highest dose
equivalent, should be relatively homogeneous with respect to the
location, habits, and metabolic characteristics that affect the doses
received; and the habits and characteristics of the group should be
based on present knowledge using cautious, but reasonable, assumptions.
Although the ICRP guidance was developed for present day releases to
existing populations that could be surveyed, monitored, and screened to
find the few actual individuals that would be members of the critical
group, the Commission has used the ICRP principles in developing
specifications for the critical group and reference biosphere.
Demonstration of compliance with an individual dose limit over
thousands of years requires the use of certain assumptions about the
characteristics of the individual or group to be protected, as well as
the characteristics of the biosphere in which the critical group
resides, for purposes of analyzing the performance of the waste
disposal facility. Difficulties in forecasting the characteristics of
future society, especially those influencing exposure, lead to large
uncertainties in the estimates of who will be exposed, by how much, and
when.
The Commission is proposing to limit speculation by specifying the
assumptions to be used by DOE in developing the assumed critical group
and reference biosphere appropriate for Yucca Mountain. The Commission
is proposing criteria at Sec. 63.115 for identifying a critical group
and reference biosphere that the Commission believes provide a
reasonable basis for demonstrating compliance and that preclude
unbounded speculation. The Commission's intent here is to define
characteristics that would otherwise be subject to unlimited
speculation, and to identify how available information is to be used by
DOE to identify the average member of the critical group. The
identification of those individuals expected to receive the highest
dose will be most sensitive to attributes such as location, percentage
of diet from locally-produced food, lifestyle, and land use. Based on
present day knowledge of the habits and characteristics of the local
population in the vicinity of Yucca Mountain, Sec. 63.115 specifies a
farming critical group located approximately 20 km south from the
underground facility (i.e., in the general location of U.S. Route 95
and Nevada Route 373, near Lathrop Wells). This section also directs
DOE to use current conditions in the region surrounding Yucca Mountain
to define the remaining attributes of the critical group.
Based on analysis to date, the Commission considers a farming
critical group to be reasonably representative of those individuals
expected to receive the highest dose from radionuclides released from a
Yucca Mountain repository for a number of reasons. First, farming
activities involve more exposure pathways than other known human
activities in the region (e.g.; ingestion pathway through consumption
of contaminated water, crops, and animal products; inhalation and
direct pathways from surface contamination exacerbated by the
significant outdoor activity of a farming lifestyle). Second, the
relatively large demand for ground water for irrigation increases the
likelihood of drawing contaminated water to the surface where human
exposures could occur. And third, farming activities currently exist in
the Yucca Mountain region.
The 20 km location (near Lathrop Wells) represents an informed
assumption regarding the accessibility of groundwater for irrigation
considering current irrigation practices, depth to the water table, and
the recognition that soil conditions at this location are generally
similar to those further down gradient, near Amargosa Valley, where
farming is currently practiced. Locations much closer to the proposed
repository have soil conditions that are considerably less favorable
for farming. Review of current well use information for Nevada suggests
that irrigation wells constructed for water table depths greater than
150 meters are rare. Because well cost is related to depth, it is
economically preferable to establish irrigation wells in areas where
the water table is near the surface. The water table at Yucca Mountain
is deep (i.e., greater than 300 meters) and decreases with distance
down-gradient, which would also be the eventual path for radionuclide
releases in the ground-water pathway. The area near U.S. Route 95 and
Nevada Route 373 is the general location where the depth to water is
approximately 100 meters with more shallow depths to water occurring
further south. Because current farming practices are concentrated in
the Amargosa Farms region (approximately 30 km south of Yucca
Mountain), the 20 km critical group distance is considered reasonably
conservative.
Other activities that currently exist in the area represent more
limited potential for exposures (e.g., casino resort/hotel, residential
dwellings). Activities such as residential housing are certainly
feasible at locations closer than 20 km, where potential release
concentrations are likely to be higher. However, the bases for
determining precise locations of such groups are likely to be highly
speculative, and largely arbitrary, when compared to a farming critical
group based on existing living patterns. Additionally, the small water
demand of a residential community, and even smaller demand of a single
residence, relative to a farming community, further increases the
uncertainty of dose estimates. Finally, because releases to the
groundwater are expected to be quite variable spatially, due to the
characteristics of fractured rock, the likelihood of any particular,
randomly selected, withdrawal well intercepting contaminated water, at
a specific location, would be quite small.
Exposures to the average member of the critical group will increase
with the amount of contaminated water, crops, and animal products
consumed, assuming the ground water pathway is the most likely release
pathway. Individuals expected to receive the highest dose would be
those for whom locally-produced, contaminated food represents a
significant fraction of their diet. The Commission is proposing that
the consumption of locally produced food for the average member of the
critical group be based on the mean of the range of the dietary habits
consistent with the current conditions in the Yucca Mountain region. It
is reasonable to assume that a farming community of
[[Page 8646]]
sufficient size (as opposed to a few isolated farms) would be needed to
supply the range of locally produced food that is currently consumed in
the Yucca Mountain region. Such a farming community of up to 100
individuals, residing on approximately 15 to 25 farms, is consistent
with current conditions of the region (substantially more farms would
increase water demand and further decrease radionuclide concentrations
in pumped water; substantially fewer farms would restrict the
availability of locally-produced food relative to the regional
average). Thus, it would be expected that the average member of the
critical group resides within a farming community and has dietary
habits which will result in the exposures being among the highest.
Exposures to the average member of the critical group will also be
affected by the degree to which the locally produced food is
contaminated. Variability in farming and water well withdrawal
practices, as well as the spatial variability of radionuclide
concentrations in ground water, will produce variation in the amount
and degree of contamination of locally produced food. The Commission
considers it desirable to constrain the determination of the
contamination levels of locally produced food because it is not
possible to precisely determine concentrations in ground water at
specific locations or to avoid speculation regarding individual farm
and water well withdrawal practices. The concentration of radionuclides
in the water used by a larger farming community, by contrast, can be
determined by dividing the annual release of radionuclides to the
location of the farming community by the annual water demands of the
farming community. For a community of sufficient size, it can be
assumed that water demand is large enough to ``capture'' the entirety
of the contaminated plume. Thus, all the locally produced food of the
farming community would be considered to be contaminated through the
use of contaminated ground water. The Commission considers this
reasonable because the average member of the critical group can be
assumed to consume contaminated food in all categories of locally
produced food. The use of mean values for defining dietary habits
ensures that dose estimates would not be unduly biased by unusual
habits of a few individuals, and speculation is minimized with respect
to where crops are grown relative to the spatial distribution of
concentration.
The biosphere in which the critical group resides affects the
group's behavior and characteristics and defines how the group could be
exposed to radionuclide releases from Yucca Mountain. The precise
future state of the biosphere over the time period considered during a
performance assessment is highly uncertain. Both natural and man-made
processes may affect attributes of the biosphere (e.g., climate,
topography, hydrology and soils), and thereby influencing exposure
pathways. As noted earlier in this notice, NAS recommended that the
assumptions about the biosphere make use of present knowledge and be
cautious, but reasonable.
The Commission's proposed implementation of the reference biosphere
concept contains four primary requirements. These include that (i)
features, events, and processes that describe the reference biosphere
shall be consistent with present knowledge and conditions in the region
surrounding the Yucca Mountain site, (ii) biosphere pathways shall be
consistent with arid or semi-arid conditions, (iii) climate evolution
shall be consistent with the geologic record of natural climate change
in the region surrounding Yucca Mountain, and (iv) evolution of the
geologic setting shall be consistent with present knowledge of natural
processes.
Reliance on present knowledge and conditions is considered
reasonable for development of exposure scenarios because such exposure
scenarios can be based on empirical knowledge rather than unconstrained
speculation. The use of current information is intended to place
primary emphasis on the provision of a framework for analysis of
repository performance, rather than on the precise prediction of
possible futures.
Requirements that the biosphere be based on arid or semiarid
conditions and that climate evolution be consistent with present
knowledge of natural climate change reflect a philosophy that, while
societal behaviors cannot be predicted, certain aspects of the
evolution of natural systems over long time frames can be predicted
based on the geologic record. Climate change studies for the Yucca
Mountain region indicate that the Yucca Mountain climate could become
cooler and wetter during the next ice age; however, analyses of the
fossil records from the previous ice age indicate that the climate in
the area south of Yucca Mountain is likely to change, at most, to
conditions consistent with a semiarid climate classification. Because
the current interpretations of the fossil record support these choices
for local climate now and into the future, it is reasonable to limit
the scope of assumed climate change to these possibilities. The change
from arid to semiarid conditions is not expected to alter the biosphere
sufficiently to cause major changes in potential exposure pathways to
the critical group. For a farming critical group, a semiarid farming
region would be expected to support agricultural crops similar to those
grown in present day Amargosa Valley. Although specific biosphere and
critical group parameters may change slightly with climate, major
changes in behavior and exposure pathways for the critical group are
not assumed.
DOE will need to establish and defend the particular
characteristics, behaviors and attributes it assumes for the critical
group and reference biosphere subject to the requirements and
specifications of Sec. 63.115. Then, as suggested by ICRP, a
hypothetical individual representing the average member of the critical
group, could be established using the mean values of the assumed
characteristics, behaviors, and attributes. It is expected that DOE
would conduct a habit survey to establish a realistic range of possible
characteristics for the critical group, recognizing that its
assumptions should be internally consistent and should not be driven by
extreme habits. The Commission believes that its proposal of a farming
critical group is reasonable for testing the ability of the geologic
repository to comply with the performance objective at Sec. 63.113
because it represents cautious, but realistic, assumptions of future
living patterns in the vicinity of Yucca Mountain based on patterns
observed there today. As this rulemaking progresses, the Commission's
ongoing performance assessment analyses will continue to examine the
influence of important assumptions such as the characteristics of the
critical group including location, lifestyle, diet, and size. As part
of this effort, the Commission encourages comments on the
appropriateness of its proposed approach to defining the critical group
and reference biosphere for Yucca Mountain. In particular, the
Commission solicits comments on other candidate population groups,
biosphere assumptions and potential exposure pathways that should be
considered in the establishment of a ``critical group'' for Yucca
Mountain.
VII. Compliance Period
The NAS recommended that the time over which compliance should be
assessed should include the time when greatest risk occurs, within the
limits imposed by the stability of the geologic
[[Page 8647]]
system. This recommendation was founded on technical considerations
only, and, as NAS acknowledged, did not address issues of policy. 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. Should EPA issue final
standards for Yucca Mountain or Congress enact new high-level waste
legislation into law that specify a different compliance period, the
NRC will amend its criteria at 10 CFR Part 63, as necessary, to comply
with EnPA requirements for consistency with final EPA standards.
The Commission makes its proposal on the basis of three
considerations. First, the inherent radiological hazard of spent fuel
decreases rapidly and significantly during the initial 10,000 years due
to radioactive decay dominated by fission products, with the relative
hazard diminished by approximately 90 percent at 100 years, 99 percent
at about 1,000 years and 99.9 percent at 10,000 years. At 10,000 years
following waste emplacement, the relative radiological hazard is within
a factor of ten of the hazard posed by a quantity of 0.2 percent
uranium ore equivalent to that which was necessary to produce the spent
fuel (Final Environmental Impact Statement on the Management of
Commercially Generated Radioactive Waste, DOE, 1980; NRC High-Level
Radioactive Waste Program Annual Progress Report; Fiscal Year 1996,
NRC, 1997). Beyond 10,000 years, the relative hazard of the disposed
waste diminishes very slowly over several hundreds of thousands of
years because decay at such late times is controlled by the activity of
longer-lived radionuclides. A 10,000-year compliance period corresponds
to the time period when the waste is inherently most hazardous.
Second, analysis of repository performance over 10,000 years
provides an opportunity to examine the impact of a range of geologic
conditions (e.g., seismic events, fault movement, igneous activity, and
climate variation on the scale of global changes due to glaciation) on
the capability of the engineered and natural barriers to limit
radiation exposures below the dose limit. It is possible that DOE may
attempt to demonstrate that its engineered barrier system design is
sufficiently robust as to preclude any significant releases during a
10,000-year compliance period. The Commission is aware of DOE's efforts
to examine a variety of engineered barrier designs that it expects will
extend the containment period of the waste package. However, the DOE
has not finalized its repository design and thus it is premature, at
this time, to assume that the expected lifetime of the engineered
barrier system will exceed the compliance period. If, indeed, the waste
package can be shown to preclude radionuclide releases beyond the
compliance period, a 10,000-year evaluation, it might be argued, would
only illustrate the effect of the natural system on the degradation of
the engineered barriers and would fail to adequately display the
capacity of extant natural barriers to restrict movement of
radionuclides following release from the waste packages, and thereby,
limit exposures to members of the critical group. The Commission
expects that in conducting its performance assessment, DOE will account
for the susceptibility of some fraction of the more than 7,000 emplaced
canisters to early failures, attributable to such causes as
manufacturing defect, lapses in quality assurance programs, etc. The
ability of the geologic barriers to retard the transport of
radionuclides released as a result of these early failures would
clearly need to be evaluated. Furthermore, the assumed intrusion
scenario specified at Sec. 63.113(d) and discussed later in this notice
requires a stylized analysis of the consequences of a compromised waste
package, and will also test the contribution of the geologic barriers
to overall performance. Irrespective of the projected lifetime of the
waste package design, the capability of the natural barriers to limit
exposures would need to be evaluated in the context of the multiple
barrier requirement.
Finally, from a policy perspective, EPA has already codified a
10,000-year compliance period at 40 CFR 191 applicable to the Waste
Isolation Pilot Plant (WIPP), a similar type of disposal system as that
proposed at Yucca Mountain. A 10,000-year performance period is also
referenced in EPA guidance on no-migration petitions for facilities
seeking exemption from certain land-disposal restrictions for long-
lived hazardous, nonradioactive materials. Additionally, a 10,000-year
compliance period is specified in NRC's Draft Technical Position on a
Performance Assessment Methodology for Low-Level Radioactive Waste
Disposal Facilities (62 FR 29164; May 29, 1997). All of these land
disposal situations, like HLW disposal, involve disposed wastes
containing long-lived, hazardous materials which are of concern,
because they can become mobile in the groundwater pathway.
The Commission proposes that a 10,000-year compliance period is
appropriate for evaluating a Yucca Mountain repository because it: (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.
VIII. Multiple Barriers and Defense in Depth
The defense-in-depth principle has served as a cornerstone of NRC's
deterministic regulatory framework for nuclear reactors, and it
provides an important tool for making regulatory decisions, with regard
to complex facilities, in the face of significant uncertainties. NRC
also has applied the concept of defense-in-depth elsewhere in its
regulations to ensure safety of licensed facilities through
requirements for multiple, independent barriers, and, where possible,
redundant safety systems and barriers. Traditionally, the reliance on
independence and redundancy of barriers has been used to provide
assurance of safety when reliable, quantitative assessments of barrier
reliability are unavailable. The Commission maintains, as it has in the
past, that the application of the defense-in-depth concept to a
geologic repository is appropriate and reasonable. The Commission now
believes, however, that its implementation, in the context of a
geologic repository, should be reexamined, in light of the advancement
in methods to quantitatively assess the
[[Page 8648]]
components of a geologic repository system and with due consideration
of the Commission's goal of a regulatory program and associated
requirements that are risk-informed and performance-based.
Development of NRC's regulations for geologic disposal in 1983
represented a unique application of the defense-in-depth philosophy to
a first-of-a-kind type of facility. While waste is being emplaced, and
before a geologic repository is closed, its operation may be amenable
to regulation comparable to other operating nuclear fuel cycle
facilities licensed by NRC. Application of defense-in-depth principles
for regulation of repository performance, for long time periods
following closure, however, must account for the difference between a
geologic repository and an operating facility with active safety
systems and the potential for active control and intervention. A closed
repository is essentially a passive system, and assessment of its
safety over long timeframes is best evaluated through consideration of
the relative likelihood of threats to its integrity and performance.
Although it is relatively easy to identify multiple, diverse barriers
that comprise the engineered and geologic systems, the performance of
any of these systems and their respective subsystems cannot and should
not be considered either truly independent or totally redundant.
As stated earlier, NWPA mandated that technical criteria developed
by the Commission `` * * * shall provide for the use of a system of
multiple barriers in the design of the repository.'' How the
performance of those barriers should be assessed, consistent with the
Commission's policy of defense-in-depth, was a major issue throughout
the development and promulgation of the Commission's generic
regulations at 10 CFR Part 60 and continues to be of concern as the
Commission contemplates new regulations for Yucca Mountain.
Well before NWPA was enacted, the Commission had considered the
appropriate bases for establishing regulations for HLW disposal. In
developing proposed generic technical criteria for Part 60, the
Commission placed primary emphasis on the need to compensate for the
large uncertainty that is inherent in the assessment of the long-term
performance of HLW disposal systems. The Commission expressed its view,
then, that the state-of-the-art in the earth sciences was such that all
the uncertainties related to predicting long-term performance of a
repository could not be resolved through consideration of the geologic
setting alone.
It should be noted that during the late 1970s and early 1980s, when
the Commission was first considering the development of proposed
technical criteria for geologic repositories, quantitative techniques
for assessing repository performance were in their infancy. The lack of
experience with, and confidence in, quantitative methods for addressing
the uncertainties associated with estimates of repository performance
weighed heavily as the Commission considered options for formulating
generic regulations for HLW disposal. As will be discussed later in
this statement, the Commission now believes that the application of
such methods has matured sufficiently to move away from its earlier
approach.
As Part 60 was being developed, the Commission gave serious
consideration to a ``systems approach,'' that is, regulation of a
repository system through a single figure of merit, that of overall
system performance, leaving maximum flexibility for determining the
extent and focus of site characterization, and for the designer to make
trade-offs among components of the system. It was noted that this
approach could include a requirement that the system design incorporate
multiple barriers to compensate for uncertainty in overall system
performance. It was believed, at the time, however, that compensation
for uncertainties in assessing the system's overall performance could
only be achieved by introducing conservatism. Intentional addition of
conservatism, either by making the measure of performance unduly
stringent or by using worst-case, bounding assumptions in the
evaluation, was argued to be impractical from a regulatory point of
view.
Instead, the Commission opted to prescribe minimum performance
standards for each of the major system elements (as they were
envisioned at the time) as well as to require the overall system to
comply with the primary performance objective, namely, whatever
standards EPA would eventually establish. This approach was thought to
have two advantages over the systems approach, if the barriers were
chosen judiciously. It was argued that barriers could be prescribed,
generically, which act ``independently,'' and that generic performance
measures for these ``independent'' barriers could be selected that
would reduce calculational uncertainty. Identification of such
subsystem performance measures was expected to be helpful input to
DOE's design process, without being overly restrictive. It is now
recognized that NRC attempted to define such criteria on the basis of
limited, existing knowledge, without benefit of research and site-
specific information that only later was acquired during
characterization of a specific site at Yucca Mountain.
The vast majority of comments received on the proposed Part 60
favored a ``systems approach.'' Nevertheless, in publishing its final
rule (48 FR 28194; June 21, 1983), the Commission elected to retain the
proposed approach, stating that ``* * * in simply adopting the EPA
standard as the sole measure of performance, it [the Commission] would
have failed to convey in any 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' and, further that ``* * * The
Commission firmly believes that the performance of the engineered and
natural barriers must each make a definite contribution in order for
the Commission to be able to conclude that the EPA standard will be
met.''
In support of the final rule, the Commission examined how
particular values for the performance of the proposed barriers would
assist in concluding that compliance with the EPA standards had been
demonstrated, given an assumed set of anticipated processes and events.
Final EPA standards still had not been promulgated, so analyses were
conducted based on NRC staff assumptions regarding the final standards.
These analyses, based on a simplified modeling study for a hypothetical
repository located in a variety of saturated geologic media, were
documented as NUREG-0804--``Staff Analyses of Public Comments on
Proposed Rule 10 CFR Part 60, Disposal of High-Level Radioactive Wastes
in Geologic Repositories.'' For many, but by no means all, of the cases
examined, compliance with the proposed subsystem performance objectives
did increase the probability of meeting the assumed EPA standards. NRC
was not able to demonstrate, however, that compliance with the
subsystem criteria alone was sufficient to meet the assumed EPA
standards, nor that compliance with the assumed EPA standards would
suffice to assure compliance with the subsystem criteria. For the cases
analyzed, however, it was asserted that the analyses `` * * *
demonstrate that compliance with 10 CFR Part 60 can substantially
increase confidence that the assumed EPA standard[s] will be met.''
Lastly, in order to address concerns that quantitative subsystem
performance criteria may unduly restrict the
[[Page 8649]]
applicant's flexibility, the Commission modified the proposed rule to
explicitly recognize the potential need to change the subsystem
objectives to account for unique features of a specific site or design.
This flexibility was provided at Sec. 60.113 (b).
Since their promulgation, the subsystem criteria in Sec. 60.113, in
particular, have not gained broad acceptance in the technical
community. These criteria have been criticized as overly prescriptive,
lacking in both a strong technical basis and a clear technical nexus to
the overall performance objective (i.e., the EPA standards), and
unclear in their wording.
In contrast to the state of performance assessment technology
assumed at the time Part 60 criteria were put in place, the NAS
Committee on Technical Bases for Yucca Mountain Standards 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.'' As has
been described earlier, it was a lack of confidence in this capability
to quantify overall performance and adequately bound uncertainty that
factored prominently in the Commission's decision to include
quantitative subsystem requirements in the Part 60 regulations. Also,
as discussed earlier, NAS cautioned against implementation of multiple
barriers through the use of subsystem performance requirements. In
addition, the Commission's Advisory Committee on Nuclear Waste (ACNW)
recently recommended that the Commission implement the concept of
defense in depth by ensuring that the effectiveness of individual
barriers be identified explicitly in the total system performance
assessment (TSPA), but specifically did not endorse the establishment
of rule-based subsystem requirements for Yucca Mountain. The ACNW noted
that ``* * * an overall performance-based regulation in the context of
a risk-based standard is a superior tool for promoting safety relative
to imposed subsystem requirements. (see letters dated October 31, 1997
and March 6, 1998).''
Upon review of this regulatory history, 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.
Specifically, when the Part 60 subsystem criteria were selected,
they were intended to be separate, ``independent,'' easily-determined
measures of subsystem performance, determination of which would require
only application of technology that was readily available. Extensive
experience with site-specific performance assessment has shown them to
be none of these. For example, because container performance, release
rate, and ground-water travel time will be derived from the same
general data and knowledge base as the TSPA, they are subject to many,
if not all, of the same uncertainties. Furthermore, waste package
performance and release rate are both a function of available water;
therefore, it is arguable whether the existing (or any other) subsystem
measures can provide truly independent assurance of total system
performance.
Nevertheless, despite 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. Although there exists an extensive geologic record ranging from
thousands to millions of years, this record is subject to
interpretation and includes many uncertainties. These uncertainties can
be quantified generally and are addressed by requiring the use of a
multiple barrier approach; specifically, an engineered barrier system,
consisting of one or more distinct engineered barriers, is required in
addition to the natural barriers implicit in a geologic setting.
Similarly, although the composition and configuration of engineered
structures, as well as their capacity to function as barriers, can be
defined with a degree of precision not possible for natural barriers,
it is recognized that except for a few archaeologic analogues, there is
no experience base for the performance of complex, engineered
structures over periods longer than a few hundred years. It is expected
that DOE will demonstrate that the natural barriers and the engineered
barrier system will work in combination to enhance overall performance
of the geologic repository.
The Commission believes that this approach to multiple barriers is
consistent with the NAS conclusions and recommendations cited above.
The Commission also recognizes, and believes it is important to
acknowledge that 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. In addition to extensive
reviews of evolving TSPAs produced by DOE and its contractors, the
Commission, itself, has developed and exercised its own technical
capability in the field of repository performance assessment (See, for
example, Bonano, E. J., et al., ``Demonstration of a Performance
Assessment Methodology for High-Level Waste Disposal in Basalt
Formation,'' NUREG/CR-4759, U.S. Nuclear Regulatory Commission,
Washington, DC, 1989; ``Initial Demonstration of the NRC's Capability
to Conduct a Performance Assessment for a High-Level Waste
Repository,'' NUREG-1327, 1992; ``NRC Iterative Performance Assessment
Phase 2--Development of Capabilities for Review of a Performance
Assessment for a High-Level Waste Repository,'' NUREG-1464, 1995).
Drawing from this experience, the Commission is now proposing to
require that DOE evaluate the behavior of barriers important to waste
isolation in the context of the performance of the geologic repository.
The Commission does not intend to specify numerical goals for the
performance of individual barriers. Such an approach will require DOE
to provide an analysis that: (1)
[[Page 8650]]
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. In implementing this approach, the Commission proposes to
incorporate flexibility into its regulations by requiring DOE to
demonstrate that the geologic repository comprises multiple barriers
but not prescribe which barriers are important to waste isolation or
the methods to describe their capability to isolate waste.
DOE could select from a variety of methods in order to demonstrate
the capability of barriers to isolate waste. Regardless of the method
and the level of quantification, it is expected that the capability of
individual barriers to perform their intended function and the
relationship of that function to limiting radiological exposure would
be described. In parallel with this rulemaking, NRC staff is developing
guidance in the form of a Yucca Mountain Review Plan. In this review
plan, guidance will be provided on acceptable methods for demonstrating
compliance with the multiple barrier requirement that could include,
but not necessarily be limited to, performing sensitivity analyses,
modeling the behavior of individual barriers, quantifying how
individual barriers contribute to performance, and delineating the
capabilities of the barriers to isolate waste. The Commission believes
that it is appropriate to afford DOE flexibility in selecting the
methods to demonstrate the waste isolation capability of the multiple
barriers that must comprise its repository design. The proposed
requirements will 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.
IX. Performance Assessment
Demonstration of compliance with the postclosure performance
objective specified at Sec. 63.113(b) requires a performance assessment
that quantitatively estimates the expected annual dose, over the
compliance period and weighted by probability of occurrence, to the
average member of the critical group. Performance assessment is a
systematic analysis of what can happen at the repository after
permanent closure, how likely it is to happen, and what can result, in
terms of dose to the average member of the critical group. Taking into
account, as appropriate, the uncertainties associated with data,
methods, and assumptions used to quantify repository performance, the
performance assessment is expected to provide a quantitative evaluation
of the overall system's ability to achieve the performance objective
(Sec. 63.113 (b)). Consistent with EnPA and the NAS recommendations,
the Commission proposes that the results of performance assessment
shall be the sole quantitative measure used to demonstrate compliance
with the postclosure individual dose limit.
In order to find that issuance of a license will not constitute an
unreasonable risk to the health and safety of the public, the
Commission must have reasonable assurance that the required performance
assessment has demonstrated that, following permanent closure, for the
duration of the compliance period and considering the likelihood of
occurrence of adverse natural events, expected annual exposures to the
average member of the critical group will not exceed the individual
dose limit of .25 mSv (25 mrem) TEDE. Although the performance
objective for the geologic repository after permanent closure
(Sec. 63.113) is generally stated in unqualified terms, it is not
expected that complete assurance that the requirement will be met can
be presented. A reasonable assurance, on the basis of the record before
the Commission, that the performance objective will be met is the
general standard that is required. Proof that the geologic repository
will be in conformance with the objective for postclosure performance
is not to be had in the ordinary sense of the word because of the
uncertainties inherent in the understanding of the evolution of the
geologic setting, biosphere, and engineered barrier system. For such
long-term performance, what is required is reasonable assurance, making
allowance for the time period, hazards, and uncertainties involved,
that the outcome will be in conformance with the objective for
postclosure performance of the geologic repository. Demonstrating
compliance, by necessity, will involve the use of complex predictive
models that are supported by limited data from field and laboratory
tests, site-specific monitoring, and natural analog studies that may be
supplemented with prevalent expert judgment. Further, in reaching a
determination of reasonable assurance, the Commission may supplement
numerical analyses with qualitative judgments including, for example,
consideration of the degree of diversity or redundancy among the
multiple barriers of the geologic repository.
Because of the significance of the performance assessment as the
sole quantitative measure of compliance, it is essential that the
performance assessment be scientifically defensible and transparent.
For this reason, the Commission considers it important to specify, at
Sec. 63.114, requirements for a complete and high-quality performance
assessment. 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)
considered for inclusion in the assessment should represent a wide
range of beneficial and detrimental effects on performance. Features,
events, and processes should be considered in light of available data
and current scientific understanding, and alternative conceptual models
that are consistent with such data and understanding should be
evaluated. Inclusion of alternative models should be based, however, on
reasonable interpretation of available information, and should not be
driven by open-ended speculation. To this end, the Commission is
proposing to constrain speculation by defining a lower limit on the
probability of events and processes that need to be considered and
requiring inclusion of only those features and processes, and higher
probability events that significantly change the expected annual dose.
The performance assessment will rely, by necessity, on computer
modeling to determine whether a proposed geologic repository meets the
performance objectives. Such reliance on computer simulation has become
commonplace for determining the likely performance of complex
engineered systems. In most applications, it is accompanied by a
rigorous testing program, involving model ``validation'' and
``verification,'' to ensure that the simulated system behavior is
sufficiently consistent with empirically observed behavior to meet the
need of the application at hand. The Commission expects that DOE will
take
[[Page 8651]]
reasonable and practical measures to ensure that its performance
assessment provides a credible representation of a geologic repository
at Yucca Mountain. For example, assurance of the soundness of the
performance assessment cannot and will not involve the comparison of
simulated behavior of a geologic repository with empirical observation
over tens of kilometers and tens of thousands of years. At best,
assurance for the performance assessment will involve comparison of
simulations with observations drawn from an integrated program of
laboratory tests, field tests, and analog studies that starts with site
characterization and continues, as appropriate, through the performance
confirmation period. To the extent that DOE's performance assessment
provides a credible representation of a geologic repository, the
Commission expects no more than that and believes that no more is
needed. When the NWPA became law in 1982, and when it was revisited in
1987, and again in 1992, the limits on human knowledge that are
attendant to confirming performance of a geologic repository were well
known. The Commission does not believe that these laws were passed with
the intention of creating an impossible task. Accordingly, the
Commission has included, at Secs. 63.101(a)(2) and 63.101(b),
explanations regarding the purpose and nature of the findings it will
make.
To be transparent, DOE's performance assessment must contain an
evaluation of the performance of the geologic repository relative to
compliance with the individual dose limit and an explanation of how the
estimated performance was achieved. Section 63.113(b) requires that
compliance with the individual dose limit be demonstrated through the
calculation of an expected annual dose. The expected annual dose is the
expected value of the annual dose considering the probability of the
occurrence of the events and the uncertainty, or variability, in
parameter values used to describe the behavior of the geologic
repository (the expected annual dose is calculated by accumulating the
dose estimates for each year, where the dose estimates are weighted by
the probability of the events and the parameters leading to the dose
estimate). Demonstration of compliance with the individual dose limit
will need to include an estimate of the expected annual dose to the
average member of the critical group that, for any single year within
the compliance period, is below the limit. Explanation of how the
estimated performance was achieved should reveal an understanding of
the relationship between the performance of individual components or
subsystems of the geologic repository and the total system performance.
Such understanding would be used to build confidence that the expected
annual dose, as asserted in the license application, is a reasonable
estimate of the performance of the geologic repository. 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.
X. Institutional Controls
The Commission is proposing to require DOE to institute active, as
well as passive, control measures to reduce the potential for
inadvertent human intrusion into the site. Reasonably prudent, active
institutional controls, consistent with the requirements of Section
801(c) of EnPA, should be maintained at the site for as long as
possible. The Commission is also proposing that DOE's passive control
measures should be designed to serve their intended purpose for as long
as practicable.
Section 801(b) of EnPA requires that:
* * * the Commission's requirements assume, to the extent
consistent with the findings and recommendations of the National
Academy of Sciences, that following repository closure, the inclusion
of engineered barriers and the Secretary's postclosure oversight of the
Yucca Mountain Site, in accordance with Subsection (c) shall be
sufficient to:
(A) prevent any activity at the site that poses an unreasonable
risk of breaching the repository's engineered or geologic barriers; and
(B) prevent any increase in the exposure of individual members of
the public to radiation beyond allowable limits.
However, as was discussed earlier in this notice, NAS concluded
that it is not reasonable to assume that a system for postclosure
oversight, based on active institutional controls, can be developed
that will eliminate entirely, over thousands of years, the possibility
of human activity that could degrade the long-term performance of the
repository.
XI. Human Intrusion
The geologic record provides a basis for evaluating the likelihood
of geologic processes and events, but no similar record of extended
duration exists that can be used to constrain either the probability
that human intrusion could occur or the characteristics of such
intrusion. Although designs can seek to warn potential intruders or to
mitigate effects associated with intrusion that does occur, they cannot
remove the potential for intrusion to occur. Similarly, repositories
cannot be designed to mitigate the full range of possible ways that
human intrusion could occur. Therefore, the Commission is proposing to
require that DOE take reasonable and prudent steps to reduce the
likelihood of human intrusion, and that DOE's repository design must
still perform as intended, if an assumed, limited intrusion does occur.
As noted earlier, the NAS also concluded that it is not possible to
make scientifically supportable predictions of the probability of human
intrusion breaching the repository's geologic or engineered barriers
over a period of 10,000 years. The NAS report recommended that human
intrusion be excluded from the performance assessment, but that the
consequences of an assumed human intrusion scenario should be
calculated to determine if repository performance would be
substantially degraded as a result of the intrusion.
The Commission agrees with the NAS recommendations to consider
human intrusion apart from the risk-based performance assessment. To
permit consideration of the potential detriment from human intrusion in
the evaluation of repository performance, the Commission proposes that
DOE be required to perform a consequence analysis that includes an
assumed intrusion scenario as specified at Sec. 63.113(d). This
consequence analysis would be identical to the performance assessment,
except that a specified human intrusion scenario is assumed to occur.
In the event of this assumed scenario, the repository is required to
perform such that the expected annual dose to the average member of the
critical group is also within allowable limits. Hazards to the
intruders themselves (drillers, miners, etc.) or to the public from
material brought to the surface by the assumed intrusion should not be
included in this analysis, according to NAS. This is because, NAS
asserts, analyses of these hazards would be unlikely to provide any
useful basis for judging the resilience of a particular repository or
design to intrusion.
The Commission does not intend to speculate on the virtual infinity
of human intrusion scenarios that could be contemplated, nor does it
intend for this analysis to address the full range of possible
intrusions that could occur. Rather, the Commission intends that this
analysis show that the repository exhibits some resilience to a breach
of
[[Page 8652]]
engineered and geologic barriers from events that are reasonably of
concern. Therefore, the Commission is proposing an assumed human
intrusion scenario that results in the breach of both engineered and
geologic barriers. The Commission believes that current practices
provide a solid basis for establishing properties for the intrusion
scenario that avoid speculation. Therefore, the Commission is proposing
that DOE use current practices for resource exploration to establish
properties (e.g., diameter of the borehole, drilling rate, composition
of drilling fluids) for the intrusion scenario. However, because the
Commission intends for this analysis to show that the repository can
still adequately perform if its barriers are breached, the Commission
is requiring DOE to assume that the borehole is not adequately sealed
to prevent infiltrating water.
Elsewhere in its regulations (e.g., 10 CFR Part 60), the Commission
has limited the extent to which reliance may be placed on active
institutional controls to prevent unacceptable radiological exposures
from the disposal of other radioactive wastes. Consistent with this
approach, the Commission is proposing that the intrusion scenario be
assumed to occur 100 years after repository closure.
The Commission is mindful that a single stylized intrusion scenario
should not be taken as a prediction of the likely manner or frequency
of intrusion. As NAS stated in its report, a ``calculation of
consequences for such an intrusion removes from consideration a number
of imponderables, each of which would otherwise need to be treated
separately, including the probability that an intrusion borehole would
intersect a waste canister, the probabilities of detection and
remediation, and the effectiveness of institutional controls and
markers to prevent intrusion. This scenario should not be interpreted
as either an optimistic or pessimistic estimate of what might actually
occur * * * We believe that the simplest scenario that provides a
measure of the ability of the repository to isolate waste and thereby
protect the public is the most appropriate scenario to use for this
purpose.''
Bearing this in mind, the Commission solicits comment on the
appropriateness of its proposed intrusion scenario, and the assumed
timing of its occurrence, as a reasonable measure for evaluating the
consequences of intrusion at a repository at Yucca Mountain.
XII. Preclosure Performance Objective
The Commission is proposing performance objectives at Sec. 63.111
to ensure that the geologic repository operations area is designed and
operated to protect against radiation exposures and releases of
radioactivity prior to permanent closure. Specifically, protection of
the worker and general public is ensured by requiring that (1) the
exposure limits codified at 10 CFR Part 20 are maintained, and (2)
during normal operations and anticipated operational occurrences, the
annual dose to any real member of the public, located beyond the
boundary of the site, shall not exceed a TEDE of 0.25 mSv (25 mrem).
The 0.25 mSv (25 mrem) limit was included to provide consistency with
requirements for the MRS and other waste management facilities (e.g.,
40 CFR 191.03(a), 10 CFR 72.104, and 10 CFR 61.40). Additionally,
numerical guides for design objectives have been specified for Category
1 design basis events and Category 2 design basis events. Category 1
design basis events are those events that are expected to occur one or
more times before permanent closure. Included in Category 1 design
basis events are events that occur regularly or moderately frequently,
and that are sometimes identified as ``normal operations'' associated
with receiving, handling, packaging, storing, emplacing, and retrieving
high-level waste. Also included in Category 1 design basis events are
those events that occur one or more times during the operating lifetime
of a facility, and that are sometimes identified as ``anticipated
operational occurrences'' or ``accidents.'' Category 2 design basis
events are those events that have at least one chance in 10,000 of
occurring before permanent closure. For an operational period of 100
years, this corresponds to an annual probability of occurrence of
10-6. Category 2 design basis events are unlikely, but
credible and potentially significant events. The Commission
incorporated similar definitions of design basis events and associated
dose limits in its generic regulations at 10 CFR Part 60 (61 FR 64257)
for evaluation of preclosure repository performance. The primary
purpose of those most recent amendments to the Commission's generic
criteria, in addition to achieving greater consistency with Part 72
requirements, was to improve clarity and sufficiency of the
requirements to protect health and safety for the full range of
credible conditions or events that could occur at an operating
repository, including low-probability events that have potentially
serious consequences. The Commission believes that the performance
objectives established by these amendments are suitable for inclusion
in its proposed criteria for preclosure operation at a Yucca Mountain
repository.
XIII. Integrated Safety Analysis of Activities at the Geologic
Repository Operations Area
The Commission is proposing that compliance with the preclosure
performance objectives would be demonstrated through an integrated
safety analysis (ISA) of the geologic repository operations area
(GROA). The ISA is a systematic examination of potential hazards at the
GROA. It identifies the potential hazards, the potential for initiating
event sequences, and describes potential event sequences and their
consequences, as well as the site, structures, systems, components,
equipment, and activities of personnel intended to mitigate or prevent
the accident sequence. Its purpose is to ensure that all relevant
hazards that could result in unacceptable consequences have been
adequately evaluated and appropriate protective measures have been
identified such that the GROA will comply with the preclosure
requirements for protection against radiation exposures and releases of
radioactive material specified in Sec. 63.111. As used here, integrated
means joint consideration of safety measures that, considered
separately, might not achieve the overall health and safety protection
desired. Such integration would include, but not be limited to,
integration of fire protection, radiation safety, criticality safety,
and chemical safety measures.
A fundamental aspect of the ISA is the identification and analysis
of Category 1 and Category 2 design basis events. Category 1 events as
described above represent ``normal operations'' while Category 2 events
represent unlikely but credible events which would challenge the design
of the GROA to maintain exposures within allowable limits. The analysis
of a specific Category 2 design basis event would include an initiating
event (e.g., an earthquake) and the associated combinations of
repository system or component failures that can potentially lead to
exposure of individuals to radiation. An example design basis event is
a postulated earthquake (the initiating event) which results in (1) the
failure of a crane lifting a spent fuel waste package inside a waste
handling building, (2) damage to the building ventilation (filtration)
system, (3) the drop and breach of the waste package, (4) damage to the
spent fuel, (5)
[[Page 8653]]
partitioning of a fraction of the radionuclide inventory to the
building atmosphere, (6) release of some radioactive material through
the damaged ventilation (filtration) system, and (7) exposure of an
individual (either a worker or a member of the public) to the released
radioactive material.
The Commission believes the proposed approach, which does not
include specification of general design criteria, is appropriate
because prescriptive design criteria may unnecessarily encumber DOE,
given the ongoing nature of site characterization of the underground
facility and evolution of facility design. The information the
Commission needs to make a finding of reasonable assurance that the
GROA will comply with the risk-informed, preclosure requirements at
Sec. 63.111, will be provided by the ISA. The Commission proposes
criteria, at Sec. 63.112, for the content of the ISA.
XIV. Quality Assurance
As is currently required by the generic criteria at 10 CFR Part 60,
the Commission is proposing that DOE implement a quality assurance
program, for the geologic repository, based on the criteria of Appendix
B of 10 CFR Part 50. Although an essentially equivalent quality
assurance program for the independent storage of spent nuclear fuel and
HLW is specified at Subpart G of 10 CFR Part 72, the Commission
believes it to be appropriate to continue to reference Appendix B for
the geologic repository at Yucca Mountain for purposes of maintaining
continuity between data collected, during site characterization,
pursuant to Part 60 requirements and those that will be collected once
Part 63 requirements take effect. The Commission is seeking comment on
the merits of this approach.
XV. Emergency Planning
When the Commission published final generic criteria for geologic
disposal in 1983, licensing requirements for emergency planning were
reserved for a later date. On June 22, 1985 (60 FR 32430), the
Commission published final amendments to 10 CFR Part 72 that codified
generic emergency planning licensing requirements for independent spent
fuel storage installations (ISFSIs) and monitored retrievable storage
facilities (MRS). These amendments provided for enhanced requirements
for offsite emergency planning at MRS facilities (as well as at any
ISFSIs that conduct similar operations) because of the broader scope of
activities that could be performed at these facilities relative to
those conducted at simpler storage installations. Like an MRS facility,
a Geologic Repository Operations Area (GROA) at Yucca Mountain is
expected to be a large industrial facility equipped to handle the
loading, unloading, and decontamination of a large number of spent fuel
and HLW shipping casks arriving by rail, heavy haul, and legal weight
truck. It will also include facilities to open shipping canisters that
are unsuitable for disposal, as well as to package bare fuel
assemblies, commercial and defense spent fuel, and commercial and
defense HLW in disposable canisters, and seal them for emplacement in
the repository. Packaging operations will be conducted in a
radiologically-controlled area that can support remote dry and pool-
handling operations. At this time, a final GROA design has not been
selected by DOE.
In promulgating final amendments at 10 CFR Part 72, the Commission
conducted an analysis of potential onsite and offsite consequences of
accidental release associated with the operation of an MRS. This
analysis is contained in NUREG-1092. Because the activities
contemplated for the GROA prior to repository closure pose similar
radiological hazards to those analyzed for operations at an MRS, the
Commission is proposing that the emergency planning licensing
requirements for preclosure operations at the Yucca Mountain repository
be comparable to those already codified in Sec. 72.32 (b). Therefore,
the Commission is proposing to require, at Subpart I, Sec. 63.161, that
DOE develop, and be prepared to implement, a plan to cope with
radiological emergencies that may occur at the GROA prior to permanent
closure, that is based on the criteria of Sec. 72.32(b).
XVI. Changes, Tests and Experiments
The Commission is proposing to set out, at Sec. 63.44, the bases on
which DOE may change the geologic repository operations area or
procedures as described in the application, and conduct tests or
experiments not described in the application, without prior Commission
approval. DOE would be required to maintain records of changes made and
tests undertaken pursuant to this section. Comparable provisions exists
at 10 CFR 50.59 for licensees of production and utilization facilities
(e.g. nuclear reactors) and at 10 CFR 72.48 for licensees of facilities
for the independent storage of spent nuclear fuel and HLW. The intent
of these requirements is to permit licensees to make changes, or to
conduct tests at a licensed facility, provided that: the changes
maintain the level of safety documented in the original licensing basis
(such as in the safety analysis report); the changes do not alter a
license condition; and the changes do not introduce a previously
unreviewed safety question.
Recently, the Commission proposed amendments to Parts 50 and 72 (63
FR 56098; October 21, 1998), to address a number of issues concerning
the implementation of these provisions for reactors and independent
spent fuel storage facilities. In particular, the proposed amendments
attempt to revise criteria for determining when an unreviewed safety
question exists. The Commission has become concerned that differing
interpretations of these requirements as they relate to an increase in
the probability of an accident, or an increase in consequences, have
contributed to disputed inspection and enforcement findings. Too
stringent an interpretation of the meaning of the requirements could
result in diversion of licensee and NRC resources for review of
inconsequential changes. Too high a threshold for NRC approval could
lead to an erosion of safety without explicit NRC review, particularly
with respect to the cumulative effect of multiple changes.
The Commission acknowledges that these issues are still under
review within the Commission, and may well undergo further modification
based upon that review or on public comments received. That being said,
the Commission sees merit in the establishment of a uniform policy
approach for addressing the change process issue. To this end, at the
same time the Commission solicits comment on proposed requirements at
Sec. 63.44 that are comparable to existing regulations for other
facilities, the Commission also seeks comment on the suitability, for a
repository at Yucca Mountain, of an approach substantially equivalent
to that proposed last year for nuclear reactors and spent fuel storage
facilities. Alternative criteria for Sec. 63.44, that could be used to
implement such an approach for a repository at Yucca Mountain, is
presented below, and should be viewed as a template for discussion.
Section 63.44 Changes, Tests, and Experiments
(a) Definitions:
(1) Change means a modification, addition or removal.
(2) Final Safety Analysis Report (as updated) means the Safety
Analysis Report for the geologic repository, submitted in accordance
with Sec. 63.21, as modified as a result of changes made
[[Page 8654]]
pursuant to Sec. 63.44, and as updated in accordance with Sec. 63.24.
(3) Procedures as described in the Final Safety Analysis Report (as
updated) means information in the Final Safety Analysis Report (as
updated) regarding how structures, systems, and components important to
safety are operated or controlled and information describing conduct of
operations.
(4) Reduction in margin of safety associated with any license
specification means that the input assumptions, analytical methods,
acceptance conditions, criteria and limits of the safety analyses,
presented in the Final Safety Analysis Report (as updated), that
established any license specification requirement, are altered in a
nonconservative manner.
(5) Tests or experiments not described in the Final Safety Analysis
Report (as updated) means any condition where the geologic repository
operations area or any of its systems, structures, and components
important to safety, or barriers important to waste isolation, are
utilized, controlled, or altered in a manner which is either:
(i) Outside the controlling parameters of the design bases as
described in the Final Safety Analysis Report (as updated); or
(ii) Inconsistent with the analyses in the Final Safety Analysis
Report (as updated).
(b)(1) DOE may make changes in the geologic repository operations
area as described in the Final Safety Analysis Report (as updated),
make changes in the procedures as described in the Final Safety
Analysis Report (as updated), and conduct tests or experiments not
described in the Final Safety Analysis Report (as updated), without
obtaining either an amendment of construction authorization pursuant to
Sec. 63.33 or a license amendment pursuant to Sec. 63.45, if a change
in the conditions incorporated in the construction authorization or
license is not required, and the change, test, or experiment does not
meet any of the criteria in paragraph (b)(2) of this section.
(2) DOE shall obtain an amendment of construction authorization
pursuant to Sec. 63.33 or a license amendment pursuant to Sec. 63.45,
prior to implementing a change, test, or experiment if it would:
(i) Result in more than a minimal increase in the probability of
occurrence of an event previously evaluated in either the Final Safety
Analysis Report (as updated), or in evaluations performed pursuant to
this section and safety analyses performed pursuant to Secs. 63.33 or
63.45, as applicable, after the last Final Safety Analysis Report was
updated pursuant to Sec. 63.24;
(ii) Result in more than a minimal increase in the probability of
occurrence of a malfunction of structures, systems, components
important to safety, or barriers important to waste isolation, which
were previously evaluated in either the Final Safety Analysis Report
(as updated), or in evaluations performed pursuant to this section and
safety analyses performed pursuant to Secs. 63.33 or 63.45, as
applicable, after the last Final Safety Analysis Report was updated
pursuant to Sec. 63.24;
(iii) Result in more than a minimal increase in the consequences of
an event previously evaluated in either the Final Safety Analysis
Report (as updated), or in evaluations performed pursuant to this
section and safety analyses performed pursuant to Secs. 63.33 or 63.45,
as applicable, after the last Final Safety Analysis Report was updated
pursuant to Sec. 63.24;
(iv) Result in more than a minimal increase in the consequences of
malfunction of structures, systems, components important to safety, or
barriers important to waste isolation, which were previously evaluated
in either the Final Safety Analysis Report (as updated), or in
evaluations performed pursuant to this section and safety analyses
performed pursuant to Secs. 63.33 or 63.45, as applicable, after the
last Final Safety Analysis Report was updated pursuant to Sec. 63.24;
(v) Create the possibility for a design basis event, or of a
pathway for release of radionuclides, of a different type than any
evaluated previously in either the Final Safety Analysis Report (as
updated), or in evaluations performed pursuant to this section and
safety analyses performed pursuant to Secs. 63.33 or 63.45, as
applicable, after the last Final Safety Analysis Report was updated
pursuant to Sec. 63.24;
(vi) Create the possibility for a malfunction of structures,
systems, and components important to safety, or barriers important to
waste isolation, with a different result than any evaluated previously
in either the Final Safety Analysis Report (as updated), or in
evaluations performed pursuant to this section and safety analyses
performed pursuant to Secs. 63.33 or 63.45, as applicable, after the
last Final Safety Analysis Report was updated pursuant to Sec. 63.24;
(vii) Result in a reduction in the margin of safety associated with
any license specification;
(viii) Result in a significant increase in occupational exposure;
(ix) Result in a significant unreviewed environmental impact.
(c)(1) DOE shall maintain records of changes in the geologic
repository operations area at the Yucca Mountain site and of changes in
procedures it has made pursuant to this section if these changes
constitute changes in the geologic repository operations area as
described in the Final Safety Analysis Report (as updated). DOE shall
also maintain records of tests and experiments carried out pursuant to
paragraph (b) of this section. These records shall include a written
evaluation that provides the bases for the determination that the
change, test, or experiment does not require an amendment of
construction authorization or license amendment pursuant to paragraph
(b)(2) of this section.
(2) DOE shall prepare annually, or at such shorter interval as may
be specified in the license, a report containing a brief description of
such changes, tests, and experiments, including a summary of the
evaluation of each. DOE shall furnish the report to the appropriate NRC
Regional Office shown in Appendix D of Part 20 of this chapter, with a
copy to the Director, Office of Nuclear Material Safety and Safeguards,
U.S. Nuclear Regulatory Commission, Washington, DC 20555. Any report
submitted pursuant to this paragraph shall be made a part of the public
record of the licensing proceedings.
As noted above, the criteria for changes, tests and experiments
that a licensee may conduct without prior NRC approval or license
amendment continue to be the subject of generic consideration by the
Commission, and may change subject to public comment received on this
notice, or on the proposed rulemaking for Parts 50 and 72, discussed
earlier. For example, in the supplementary information accompanying the
latter, the Commission identified a range of possible definitions for
what may constitute a ``reduced margin of safety,'' including its
deletion as a criterion. Also, it should be noted that, depending on
the outcome of the Commission's generic deliberations, it may be
necessary to modify Secs. 63.44 and 63.46, as proposed in this notice,
to eliminate, altogether, the concept of an ``unreviewed safety
question.''
Irrespective of the specific approach and criteria selected, the
Commission is also interested in whether criteria for changes, tests
and experiments should apply solely to the Safety Analysis Report or to
the contents of the entire license application, as proposed.
[[Page 8655]]
XVII. Relationship to Generic Criteria at 10 CFR Part 60
The proposed criteria will apply specifically and exclusively to
the proposed repository at Yucca Mountain. Consistent with this intent,
the Commission proposes to modify its generic criteria at 10 CFR Part
60 to make clear that they do not apply, nor may they be the subject of
litigation, in any NRC licensing proceeding for a repository at Yucca
Mountain.
Corresponding administrative changes to Parts 2, 19, 20, 21, 30,
40, 51, and 61 are being proposed to reflect the potential of licensing
a HLW geologic repository under proposed Part 63 as well as Part 60. In
appropriate sections of Parts 2, 19, 20, 21, 30, 40, 51, and 61 where
Part 60 is mentioned, a reference to Part 63 is added. 2
---------------------------------------------------------------------------
\2\ Although the NRC has recently published final rule
amendments to update its rules of practice in Subpart J of Part 2
for the licensing proceeding on disposal of HLW at a geologic
repository (62 FR 71729; December 30, 1998), any further changes to
Subpart J that are necessary to conform to the addition of Part 63
will be deferred until completion of this rulemaking.
---------------------------------------------------------------------------
XVIII. Section-by-Section Analysis of Part 63
Subpart A--General Provisions
This subpart, except for Sec. 63.2, ``Definitions,'' contains
proposed general provisions that are similar to the provisions of Part
60 with minor wording changes for simplification, clarification, or to
refer specifically to the Yucca Mountain site, where appropriate.
Definitions have been revised to reflect usage in this part, as
appropriate.
Section 63.1 Purpose and scope. This section defines the purpose
and scope of Part 63 to be limited to the licensing of DOE to receive
and possess source, special nuclear, and byproduct material at a
geologic repository operations area sited, constructed, or operated at
Yucca Mountain, Nevada. It states that generic regulations at Part 60
of this title do not apply, and cannot be the subject of any litigation
in any licensing proceeding for the Yucca Mountain site.
Section 63.2 Definitions. This section contains definitions of
terms as used in this part.
Section 63.3 License required. This section prohibits DOE from
receiving or possessing source, special nuclear, or byproduct material
at a geologic repository operations area at the Yucca Mountain site
without having a license issued by the Commission, and prohibits DOE
from beginning construction of the geologic repository operations area
without authorization from the Commission.
Section 63.4 Communications and records. This section describes
requirements for communications and reports submitted to the
Commission, including appropriate addresses for communications to be
forwarded to NRC.
Section 63.5 Interpretations. This section specifies when
interpretations of the meaning of the regulations in this part by NRC
officers or employees will be considered binding on the Commission.
Section 63.6 Exemptions. This section states the bases on which the
Commission may grant exemptions from the requirements of this part.
Section 63.7 License not required for certain preliminary
activities. This section allows DOE to possess source, special nuclear,
or byproduct material at Yucca Mountain for the purposes of site
characterization, and for use in certain construction activities.
Section 63.8 Information collection requirements: Approval. This
section indicates that the information collection requirements
contained in this part have been reviewed and approved by the Office of
Management and Budget in accordance with the Paperwork Reduction Act.
Section 63.9 Employee protection. This section specifies
requirements for protection of licensee or contractor and subcontractor
personnel from certain adverse actions by employers.
Section 63.10 Completeness and accuracy of information. This
section requires information provided to the Commission be complete and
accurate. It also requires NRC notification of information having
significant public health and safety implications.
Section 63.11 Deliberate misconduct. This section prohibits certain
licensee activities and describes resulting enforcement action.
Subpart B--Licenses
This subpart, except for Sec. 63.15, ``Site characterization,''
Sec. 63.16, ``Review of site characterization activities,'' and
Sec. 63.21, ``Content of application,'' contains proposed provisions
that are similar to the licensing provisions of Part 60 with minor
wording changes for simplification, clarification or to refer to the
Yucca Mountain site, where appropriate. Provisions related to the
content of the license application have been developed to be consistent
with the proposed technical criteria of Subpart E. Provisions related
to site characterization have been simplified from similar sections of
Part 60 to reflect the maturity of site characterization at Yucca
Mountain. For example, there are no provisions requiring DOE to prepare
and submit a site characterization plan to NRC or any requirement for
NRC to prepare a specific site characterization analysis in as much as
both activities have been completed previously. However, provisions
requiring DOE to undertake site characterization and submit semiannual
progress reports to NRC and provisions allowing NRC to comment on any
aspect of site characterization or performance assessment, at any time,
are proposed as indicated in the analysis of pertinent sections of
Subpart B that follows.
Section 63.15 Site characterization. This section specifies that a
program of site characterization is to be conducted prior to submittal
of an application and that investigations are to be conducted in a
manner that limits adverse effects on the performance of the geologic
repository.
Section 63.16 Review of site characterization activities. This
section specifies that DOE must submit to the Commission semiannual
reports on the progress of site characterization, that NRC staff shall
be permitted to visit, inspect, and observe site characterization
activities at the Yucca Mountain site, and that the Director may at any
time comment on any aspect of site characterization and performance
assessment. This section also specifies that the Commission will
determine whether any proposed onsite testing with radioactive material
during site characterization is necessary to provide data for the
preparation of the environmental reports required by law and for the
license application.
Section 63.21 Content of application. This section specifies that
the license application must include general information, a safety
analysis report, and be accompanied by an environmental impact
statement. This section also describes the detailed information to be
included in the safety analysis report.
Section 63.22 Filing and distribution of application. This section
describes requirements for filing and distribution of the license
application, amendments to the license application, environmental
reports, and related updates and supplements.
Section 63.23 Elimination of repetition. This section allows DOE to
incorporate by reference information in previous applications,
statements, or reports filed with the Commission in its application or
environmental statement.
Section 63.24 Updating of application and environmental impact
statement. This section requires DOE to submit a complete application,
to update or supplement the application or environmental impact
statement in a
[[Page 8656]]
timely manner, and certify that updated copies contain current
information.
Section 63.31 Construction authorization. This section states the
bases on which the Commission may authorize construction of a geologic
repository operations area at the Yucca Mountain site.
Section 63.32 Conditions of construction authorization. This
section indicates that the Commission will include conditions in the
construction authorization as necessary to protect the health and
safety of the public, the common defense and security, and
environmental values and describes specific provisions and restrictions
that will be included in the construction authorization. This section
also indicates that a license will not be issued until DOE has updated
its application as required at Sec. 63.24 and the Commission has made
the findings stated at Sec. 63.41.
Section 63.33 Amendment of construction authorization. This section
requires DOE to apply for an amendment of the construction
authorization if changes are desired. This section also states the
bases on which the Commission may approve an amendment of the
construction authorization.
Section 63.41 Standards for issuance of a license. This section
states the bases on which the Commission may issue a license to receive
and possess source, special nuclear, or byproduct material at a
geologic repository operations area at the Yucca Mountain site.
Section 63.42 Conditions of license. This section indicates that
the Commission will include conditions or specifications in the license
as necessary to protect the health and safety of the public, the common
defense and security, and environmental values. This section also
identifies general conditions that will be considered conditions of the
license, whether stated in the license or not.
Section 63.43 License specification. This section indicates that
the Commission will include conditions in the license that are derived
from the analyses and evaluations included in the application and
amendments made before a license is issued. This section also describes
specific categories of restrictions, requirements, and controls that
will be included as conditions of the license.
Section 63.44 Changes, tests, and experiments. This section states
the bases on which DOE may change the geologic repository operations
area or procedures as described in the application, and conduct tests
or experiments not described in the application, without prior
Commission approval. This section also requires DOE to maintain records
of changes made and tests undertaken pursuant to this section.
Section 63.45 Amendment of license. This section requires DOE to
apply for an amendment of the license if changes are desired. This
section also states the bases on which the Commission may approve an
amendment of the license.
Section 63.46 Particular activities requiring license amendment.
This section describes specific activities that require amending the
license prior to being performed, unless expressly authorized in the
license.
Section 63.51 License amendment for permanent closure. This section
requires DOE to apply for an amendment of the license to permanently
close a geologic repository at the Yucca Mountain site. This section
also requires DOE to submit an update of the license application and
describes the detailed information to be included in the update.
Section 63.52 License termination. This section requires DOE to
apply for an amendment to terminate the license following permanent
closure of the geologic repository and the decontamination or
dismantlement of surface facilities at the Yucca Mountain site.
Subpart C--Participation by State Government and Affected Indian Tribes
This subpart contains proposed provisions that are similar to the
State and affected Indian Tribe participation provisions of 10 CFR Part
60 with minor wording changes to refer to the State of Nevada and Yucca
Mountain site, where appropriate.
Section 63.61 Provision of information. This section states that
NRC shall provide to the Governor, the Nevada State legislature, and
any affected Indian Tribe timely and complete information regarding
determinations made by the Commission with respect to the Yucca
Mountain site. NRC shall also make this information available to the
public and DOE.
Section 63.62 Site review. This section states that NRC shall
consult with the State of Nevada and affected Indian Tribes regarding
site characterization activities.
Section 63.63 Participation in license reviews. This section sets
forth procedures for State and local governments and affected Indian
Tribes to participate in license review activities.
Section 63.64 Notice to state. This section notes that, if the
Governor and legislature of the State of Nevada have designated a joint
person or entity to receive information from NRC, NRC will send such
information to the jointly designated addressee.
Section 63.65 Representation. This section allows the Commission to
request that any person acting as a representative of the State,
Governor, or legislature of Nevada, or any affected Indian Tribe
provide the Commission with the authority basis for such a
representation.
Subpart D--Records, Reports, Tests, and Inspections
This subpart contains proposed provisions that are similar to the
records, reports, tests, and inspection provisions of Part 60 with
minor wording changes for simplification, clarification or to refer to
the Yucca Mountain site, as appropriate.
Section 63.71 Records and reports. This section requires DOE to
make and maintain records and reports as required by conditions of the
license or rules, regulations, and orders of the Commission.
Section 63.72 Construction records. This section requires DOE to
maintain records of the construction of the geologic repository
operations area and describes the types of records to be maintained.
Section 63.73 Reports of deficiencies. This section requires DOE to
notify the Commission of each deficiency found in the characteristics
of the Yucca Mountain site and design and construction of the geologic
repository operations area, if the uncorrected deficiency could be a
safety hazard, represent a deviation from the design criteria or design
bases, or represent a deviation from conditions of the construction
authorization or license.
Section 63.74 Tests. This section requires DOE to perform such
tests, or to allow the Commission to perform such tests, as the
Commission determines necessary for administration of the regulations
in this part. This section also describes the types of tests that may
be included under this section.
Section 63.75 Inspections. This section requires DOE to afford the
Commission opportunity for inspection of the geologic repository
operations area and adjacent areas. This section also requires DOE to
provide office space for Commission inspection personnel.
Section 63.78 Material control and accounting records and reports.
This section requires DOE to establish a material inventory system,
whereby material and accounting procedures are developed, physical
inventories are
[[Page 8657]]
performed, loss of special nuclear material, or accidental criticality
is reported, and material status and nuclear material transfer reports
are generated. This section notes that the material and accounting
program is to be the same as that specified at Secs. 72.72, 72.74,
72.76, and 72.78.
Subpart E--Technical Criteria
This subpart, except for Sec. 63.101, ``Purpose and nature of
findings,'' Sec. 63.102, ``Concepts,'' and Sec. 63.121, ``Requirements
for ownership and control of interests in land,'' contains proposed
performance objectives for the geologic repository area through
permanent closure (preclosure) and the geologic repository after
permanent closure (postclosure), and requirements for the analyses used
to demonstrate compliance with the performance objectives. The
preclosure performance objective is similar to the provisions in Part
60. However, the postclosure performance objective and other
requirements differ significantly from Part 60. This subpart proposes
compliance to be demonstrated in the context of safety analyses of
total system performance and does not prescribe general design or
siting criteria, or specific quantitative subsystem performance
objectives as was done in Part 60. The Commission is proposing an
individual dose limit that is believed to be generally consistent with
the Energy Policy Act of 1992 and the findings and recommendations of
the National Academy of Sciences' technical bases for Yucca Mountain
Standards. When final EPA standards for Yucca Mountain are published,
the Commission will amend its regulations to be consistent with the
standards, if necessary.
Section 63.101 Purpose and nature of findings. This section
describes the Commission's expectations for demonstration that the
geologic repository will be in conformance with the performance
objectives.
Section 63.102 Concepts. This section provides a functional
overview of this subpart.
Section 63.111 Performance objectives for the geologic repository
operations area through permanent closure. This section requires DOE to
design the geologic operations area to comply with the exposure limits
given in this section, conduct an integrated safety analysis, permit
implementation of a performance confirmation program, and preserve the
option for waste retrieval.
Section 63.112 Requirements for integrated safety analysis of the
geologic repository operations area. This section specifies the
requirements for the integrated safety analysis used to demonstrate
compliance with the performance objective through permanent closure
provided at Secs. 63.111(a)(1) and 63.111(a)(2).
Section 63.113 Performance objective for the geologic repository
after permanent closure. This section requires DOE to include a system
of multiple barriers for the geologic repository, comply with the
individual annual dose limit, conduct a performance assessment, and
assess the consequences of a specified human intrusion event.
Section 63.114 Requirements for performance assessment. This
section specifies the requirements for the performance assessment used
to demonstrate compliance with the individual dose limit specified at
Sec. 63.113(b).
Section 63.115 Required characteristics of the reference biosphere
and critical group. This section specifies characteristics of the
reference biosphere and critical group to be used by DOE in their
performance assessment.
Section 63.121 Requirements for ownership and control of interests
in land. This section requires DOE to have permanent control of the
site. It states that DOE shall set up controls necessary to prevent
adverse human actions that could affect the repository. DOE is required
to obtain water rights needed for the repository.
Subpart F--Performance Confirmation Program
This subpart contains proposed provisions that are similar to the
performance confirmation provisions of 10 CFR Part 60.
Section 63.131 General requirements. This section states the
objectives of the performance confirmation program and specifies that
the program be started during site characterization and continue until
permanent closure.
Section 63.132 Confirmation of geotechnical and design parameters.
This section requires DOE to monitor subsurface conditions during
repository construction and operation to confirm original design
assumptions and to ensure that performance of geologic and engineered
features is within design limits. DOE is also required to inform the
Commission of any design changes needed to accommodate actual field
conditions encountered.
Section 63.133 Design testing. This section requires DOE to
undertake a program of in situ testing of such features as borehole and
shaft seals, backfill, and the thermal interaction effects of waste
packages, backfill, rock, and groundwater.
Section 63.134 Monitoring and testing waste packages. This section
requires DOE to establish a program for monitoring and testing waste
packages at the geologic repository operations area that is to continue
as long as practical up to the time of permanent closure.
Subpart G--Quality Assurance
This subpart contains proposed provisions that are similar to the
quality assurance provisions of 10 CFR Part 60.
Section 63.141 Scope. This section requires DOE to establish a
quality assurance program to be applied at the geologic repository at
the Yucca Mountain site.
Section 63.142 Applicability. This section indicates that the
quality assurance program applies to all systems, structures, and
components important to safety, to design and characterization of
barriers important to waste isolation, and to activities related
thereto.
Section 63.143 Implementation. This section indicates that the
quality assurance program is to be based on the criteria of Appendix B
of 10 CFR Part 50, as applicable and appropriately supplemented as
required by Sec. 63.142.
Subpart H--Training and Certification of Personnel
This subpart contains proposed provisions that are similar to the
training and certification provisions of 10 CFR Part 60.
Section 63.151 General requirements. This section specifies that
operations of systems and components important to safety are to be
performed only by trained and certified personnel or by personnel under
the direct visual supervision of an individual with training and
certification in such operations. This section also specifies that
supervisory personnel who direct operations that are important to
safety are to be certified in such operations.
Section 63.152 Training and certification program. This section
specifies that a program for training, proficiency testing,
certification, and requalification of operating and supervisory
personnel is to be established.
Section 63.153 Physical requirements. This section specifies
physical requirements for personnel certified for operations that are
important to safety.
Subpart I--Emergency Planning Criteria
This subpart contains proposed provisions for emergency planning.
[[Page 8658]]
Section 63.161 Emergency plan for the geologic repository
operations area through permanent closure. This section requires DOE to
develop and be prepared to implement a plan to cope with radiological
emergencies. The section indicates that the emergency plan is to be
based on criteria at Sec. 72.32(b).
Subpart J--Violations
This subpart contains proposed provisions that are similar to the
violation provisions of 10 CFR Part 60.
Section 63.171 Violations. This section specifies actions the
Commission may take, including obtaining a court order to prevent a
violation, and contains civil penalty provisions.
Section 63.172 Criminal penalties. This section specifies criminal
sanctions for violations. For purposes of Section 223 of the Atomic
Energy Act of 1954, as amended, that provides for criminal sanctions,
all regulations in Part 63 are issued under one or more of Secs. 161b,
161i, or 161o except for the sections listed in Sec. 63.172(b).
XIX. Section-by-Section Analysis of Changes to Other Parts
Section-by-section analysis of changes to Parts 2,19, 20, 21, 30,
40, 51, and 61.
10 CFR Part 2
Section 2.101 Filing of applications is amended to add reference to
Part 63 in the procedures for filing of applications.
Section 2.103 Action on applications for byproduct, source, special
nuclear material, and operator licenses is amended to add reference to
Part 63 in the procedures for notification in this section.
Section 2.104 Notice of hearing is amended to add reference to Part
63 in the procedures for notification of hearings.
Section 2.105 Notice of proposed action is amended to add reference
to Part 63 in the procedures for notification of proposed actions in
this section.
Section 2.106(c) Notice of issuance is amended to provide for
public notification of any action with respect to a license application
or license amendment pursuant to Part 63.
10 CFR Part 19
Section 19.2 Scope is amended to make Part 63 subject to the
regulations in Part 19.
Section 19.3 Definitions is amended to add Part 63 to the
definition of ``license.''
10 CFR Part 20
Section 20.1002 Scope is amended to make Part 63 subject to the
regulations in Part 20.
10 CFR Part 21
Section 21.2(a) Scope is amended to make Part 63 subject to the
regulations in Part 21.
Certain definitions in Sec. 21.3 Definitions are amended to include
Part 63.
By changes to Sec. 21.21 Notification of failure to comply or of a
defect and its evaluation, Part 63 is made subject to the regulations
for reporting defects and noncompliance.
10 CFR Part 30
Changes to Sec. 30.11 Specific exemptions make DOE exempt from Part
30 regulations for activities subject to Part 63.
10 CFR Part 40
Changes to Sec. 40.14 Specific exemptions make DOE exempt from Part
40 regulations for activities subject to Part 63.
10 CFR Part 51
Section 51.20 Criteria for and identification of licensing and
regulatory actions requiring environmental impact statements is amended
to add reference to Part 63 under actions requiring environmental
impact statements.
Section 51.22 Criteria for categorical exclusion; identification of
licensing and regulatory actions eligible for categorical exclusion or
otherwise not requiring environmental review is amended to add
reference to Part 63 in requirements for categorical exclusion from
environmental review.
Section 51.26 Requirement to publish notice of intent and conduct
scoping process is amended to add reference to Part 63 in procedures
for receipt of an application and accompanying environmental impact
statement from DOE.
Section 51.67 Environmental information concerning geologic
repositories is amended to add reference to Part 63 in requirements for
submission of an environmental impact statement by DOE.
10 CFR Part 61
Section 61.1 Purpose and scope is amended to state that the
regulations of Part 61 do not apply to disposal of HLW as provided for
in Part 63.
Section 61.2 Definitions, the definition of ``land disposal
facility'' is amended to clarify that a geologic repository as defined
in Part 63 is not considered a land disposal facility.
Section 61.55 Waste classification is amended to add reference to
Part 63 in the definition of a geologic repository.
XX. Specific Questions for Public Comment
The Commission welcomes comments on all aspects of this proposed
rule, and is especially interested in receiving comments on the
following:
1. The Commission solicits comments on the appropriateness of its
proposed approach to defining the critical group and reference
biosphere for Yucca Mountain. In particular, the Commission solicits
comments on any other candidate population groups, biosphere
assumptions and potential exposure pathways that should be considered
in the establishment of a ``critical group'' for Yucca Mountain.
2. The Commission solicits comments on the appropriateness of its
proposed human intrusion scenario, and the assumed timing of its
occurrence, as a reasonable measure for evaluating the consequences of
intrusion at a repository at Yucca Mountain.
3. The Commission solicits comment on the merits of requiring DOE
to implement a quality assurance program for the geologic repository
based on the criteria of Appendix B of 10 CFR Part 50.
4. The Commission solicits comments on the suitability of
alternative criteria for proposed Sec. 63.44. These alternative
criteria are included in the statement of considerations discussion of
proposed Sec. 63.44 and are substantially equivalent to that proposed
last year for nuclear reactors and spent fuel storage facilities.
5. The Commission solicits comments on whether the approach and
criteria for changes, tests, and experiments at Sec. 63.44 should apply
solely to the Safety Analysis Report or to the contents of the entire
license application, irrespective of whether proposed Sec. 63.44 or the
alternative criteria presented in the statement of consideration are
selected.
XXI. Plain Language
The Presidential memorandum dated June 1, 1998, entitled ``Plain
Language in Government Writing,'' directed that the Federal
government's writing be in plain language. The NRC requests comments on
this proposed rule specifically with respect to the clarity and
effectiveness of the language used. Comments should be sent to the
address listed above.
[[Page 8659]]
XXII. Finding of No Significant Environmental Impact: Availability
Pursuant to Section 121(c) of the Nuclear Waste Policy Act, this
proposed rule does not require the preparation of an environmental
impact statement under Section 102(2)(c) of the National Environmental
Policy Act of 1969 or any environmental review under subparagraph (E)
or (F) of Section 102(2) of such act.
XXIII. Paperwork Reduction Act Statement
This proposed rule contains information collection requirements
that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This rule has been submitted to the Office of Management and
Budget for review and approval of the paperwork requirements.
The public reporting burden for this collection of information is
estimated to average 121 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. The U.S. Nuclear Regulatory Commission is
seeking public comment on the potential impact of the information
collection contained in the proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of NRC, including whether the information
will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
Send comments on any aspect of this proposed information
collection, including suggestions for reducing this burden, to the
Records Management Branch (T-6F-33), U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, or by Internet electronic mail
at BJS1@nrc.gov; and to the Desk Officer, Office of Information and
Regulatory Affairs, NEOB-10202, (3150-AG04), Office of Management and
Budget, Washington, DC 20503.
Comments to OMB on the information collections or on the above
issues should be submitted by March 24, 1999. Comments received after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given to comments received after this date.
Public Protection Notification
If a means used to impose an information collection does not
display a currently valid OMB control number, the NRC may not conduct
or sponsor, and a person is not required to respond to, the information
collection.
XXIV. Regulatory Analysis
The NRC has prepared a regulatory analysis on this regulation. The
analysis examines the alternatives considered by NRC. The analysis is
available for inspection in the NRC Public Document Room, 2120 L Street
NW. (Lower Level), Washington, DC. Single copies of the analysis may be
obtained from Clark Prichard, Office of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555,
telephone (301) 415-6203, e-mail [email protected]
XXV. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act (5 U.S.C.
605(b)), the Commission certifies that this rule will not, if
promulgated, have a significant economic impact on a substantial number
of small entities. This proposed rule relates to the licensing of only
one entity, the Department of Energy, which does not fall within the
scope of the definition of ``small entities'' set forth in the
Regulatory Flexibility Act.
XXVI. Backfit Statement
The NRC has determined that the backfit rule, 10 CFR 50.109, does
not apply to this proposed rule and, therefore, that a backfit analysis
is not required because this rule does not involve any provisions which
would impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects
10 CFR Part 2
Administrative procedure and practice, Antitrust, Byproduct
material, Classified information, Environmental protection, Nuclear
materials, Nuclear power plants and reactors, Penalties, Sex
discrimination, Source material, Special nuclear material, Waste
treatment and disposal.
10 CFR Part 19
Criminal penalties, Environmental protection, Nuclear materials,
Nuclear power plants and reactors, Occupational safety and health,
Radiation protection, Reporting and recordkeeping requirements, Sex
discrimination.
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear
materials, Nuclear power plants and reactors, Occupational safety and
health, Packaging and containers, Radiation protection, Reporting and
recordkeeping requirements, Special nuclear material, Source material,
Waste treatment and disposal.
10 CFR Part 21
Nuclear power plants and reactors, Penalties, Radiation protection,
Reporting and recordkeeping requirements.
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
protection, Reporting and recordkeeping requirements.
10 CFR Part 40
Criminal penalties, Government contracts, Hazardous materials
transportation, Nuclear materials, Reporting and recordkeeping
requirements, Source material, Uranium.
10 CFR Part 51
Administrative practice and procedure, Environmental impact
statement, Nuclear materials, Nuclear power plants and reactors,
Reporting and recordkeeping requirements.
10 CFR Part 60
Criminal penalties, High-level waste, Nuclear power plants and
reactors, Nuclear materials, Reporting and recordkeeping requirements,
Waste treatment and disposal.
10 CFR Part 61
Criminal penalties, Low level waste, Nuclear materials, Reporting
and recordkeeping requirements, Waste treatment and disposal.
10 CFR Part 63
Criminal penalties, High-level waste, Nuclear power plants and
reactors, Nuclear materials, Reporting and recordkeeping requirements,
Waste treatment and disposal.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as
amended; and 5 U.S.C. 552 and 553, the NRC is proposing to adopt the
following amendments to 10 CFR Parts 2, 19, 20, 21, 30, 40, 51, and 60
and to add the new 10 CFR Part 63.
[[Page 8660]]
PART 2--RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND
ISSUANCE OF ORDERS
1. The authority citation for Part 2 continues to read as follows:
Authority: Secs. 161, 181, 68 Stat. 948, 953, as amended (42
U.S.C. 2201, 2231); sec. 191, as amended, Pub. L. 87-615, 76 Stat.
409 (42 U.S.C. 2241); sec. 201, 88 Stat. 1242, as amended (42 U.S.C.
5841); 5 U.S.C. 552.
Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104,
105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42
U.S.C. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub.
L. 97-425, 96 Stat. 2213, as amended (42 U.S.C. 10134(f)); sec. 102,
Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301,
88 Stat. 1248 (42 U.S.C. 5871). Sections 2.102, 2.103, 2.104, 2.105,
2.721 also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat.
936, 937, 938, 954, 955, as amended (42 U.S.C. 2132, 2133, 2134,
2135, 2233, 2239). Section 2.105 also issued under Pub. L. 97-415,
96 Stat. 2073 (42 U.S.C. 2239). Sections 2.200-2.206 also issued
under secs. 161 b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83
Stat. 444, as amended (42 U.S.C. 2201 (b), (i), (o), 2236, 2282);
sec. 206, 88 Stat 1246 (42 U.S.C. 5846). Sections 2.205(j) also
issued under Pub. L. 101-410, 104 Stat. 890, as amended by section
31001(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note).
Sections 2.600-2.606 also issued under sec. 102, Pub. L. 91-190, 83
Stat. 853, as amended (42 U.S.C. 4332). Sections 2.700a, 2.719 also
issued under 5 U.S.C. 554. Sections 2.754, 2.760, 2.770, 2.780 also
issued under 5 U.S.C. 557. Section 2.764 also issued under secs.
135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155,
10161). Section 2.790 also issued under sec. 103, 68 Stat. 936, as
amended (42 U.S.C. 2133) and 5 U.S.C. 552. Sections 2.800 and 2.808
also issued under 5 U.S.C. 553. Section 2.809 also issued under 5
U.S.C. 553 and sec. 29, Pub. L. 85-256, 71 Stat. 579, as amended (42
U.S.C. 2039). Subpart K also issued under sec. 189, 68 Stat. 955 (42
U.S.C. 2239); sec. 134, Pub. L. 97-425, 96 Stat. 2230 (42 U.S.C.
10154). Subpart L also issued under sec. 189, 68 Stat. 955 (42
U.S.C. 2239). Appendix A also issued under sec. 6, Pub. L. 91-560,
84 Stat. 1473 (42 U.S.C. 2135).
2. Section 2.101 is amended by revising paragraphs (f)(1) and
(f)(5) to read as follows:
Sec. 2.101 Filing of applications.
* * * * *
(f)(1) Each application for a license to receive and possess high-
level radioactive waste at a geologic repository operations area
pursuant to Parts 60 or 63 of this chapter and any environmental impact
statement required in connection therewith pursuant to Subpart A of
Part 51 of this chapter shall be processed in accordance with the
provisions of this paragraph.
* * * * *
(5)(i) If a tendered document is acceptable for docketing, the
applicant will be requested to--
(A) Submit to the Director of Nuclear Material Safety and
Safeguards such additional copies of the application and environmental
impact statement as the regulations in Part 60 or 63 and Subpart A of
Part 51 of this chapter require;
(B) Serve a copy of such application and environmental impact
statement on the chief executive of the municipality in which the
geologic repository operations area is to be located, or if the
geologic repository operations area is not to be located within a
municipality, on the chief executive of the county (or to the Tribal
organization, if it is to be located within an Indian reservation); and
(C) Make direct distribution of additional copies to Federal,
state, Indian Tribe, and local officials in accordance with the
requirements of this chapter, and written instructions from the
Director of Nuclear Material Safety and Safeguards.
(ii) All such copies shall be completely assembled documents,
identified by docket number. Subsequently distributed amendments to the
application, however, may include revised pages to previous submittals
and, in such cases, the recipients will be responsible for inserting
the revised pages.
* * * * *
3. Section 2.103 is amended by revising paragraph (a) to read as
follows:
Sec. 2.103 Action on applications for byproduct, source, special
nuclear material, and operator licenses.
(a) If the Director of Nuclear Reactor Regulation or the Director
of Nuclear Material Safety and Safeguards, as appropriate, finds that
an application for a byproduct, source, special nuclear material, or
operator license complies with the requirements of the Act, the Energy
Reorganization Act, and this chapter, he will issue a license. If the
license is for a facility, or for the receipt of waste radioactive
material from other persons for the purpose of commercial disposal by
the waste disposal licensee, or if it is to receive and possess high-
level radioactive waste at a geologic repository operations area
pursuant to Part 60 or 63 of this chapter, the Director of Nuclear
Reactor Regulation or the Director of Nuclear Material Safety and
Safeguards, as appropriate, will inform the State, Tribal, and local
officials specified in Sec. 2.104(e) of the issuance of the license.
For notice of issuance requirements for licenses issued pursuant to
part 61 of this chapter, see Sec. 2.106(d).
* * * * *
4. Section 2.104 is amended by revising paragraph (e) to read as
follows:
Sec. 2.104 Notice of hearing.
* * * * *
(e) The Secretary will give timely notice of the hearing to all
parties and to other persons, if any, entitled by law to notice. The
Secretary will transmit a notice of the hearing on an application for a
license for a production or utilization facility, for a license for
receipt of waste radioactive material from other persons for the
purpose of commercial disposal by the waste disposal licensee, for a
license under Part 61 of this chapter, for a license to receive and
possess high-level radioactive waste at a geologic repository
operations area pursuant to Part 60 or 63 of this chapter, and for a
license under Part 72 of this chapter to acquire, receive or possess
spent fuel for the purpose of storage in an independent spent fuel
storage installation (ISFSI) to the governor or other appropriate
official of the State and to the chief executive of the municipality in
which the facility is to be located or the activity is to be conducted
or, if the facility is not to be located or the activity conducted
within a municipality, to the chief executive of the county (or to the
Tribal organization, if it is to be so located or conducted within an
Indian reservation).
5. Section 2.105 is amended by revising paragraph (a)(5) to read as
follows:
Sec. 2.105 Notice of proposed action.
(a) * * *
(5) A license to receive and possess high-level radioactive waste
at a geologic repository operations area pursuant to Part 60 or 63 of
this chapter.
* * * * *
6. Section 2.106 is amended by revising paragraph (c) to read as
follows:
Sec. 2.106 Notice of issuance.
* * * * *
(c) The Director of Nuclear Material Safety and Safeguards will
also cause to be published in the Federal Register notice of, and will
inform the State, local, and Tribal officials specified in
Sec. 2.104(e) of any action with respect to, an application for a
license to receive and possess high-level radioactive waste at a
geologic repository operations area pursuant to Parts 60 or 63 of this
chapter, or for the amendment to such license for which a notice of
proposed action has been previously published.
* * * * *
[[Page 8661]]
PART 19--NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS; INSPECTION
AND INVESTIGATIONS
7. The authority citation for Part 19 continues to read as follows:
Authority: Secs. 53, 63, 81, 103, 104, 161, 186, 68 Stat. 930,
933, 935, 936, 937, 948, 955, as amended, sec. 234, 83 Stat. 444, as
amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073,
2093, 2111, 2133, 2134, 2201, 2236, 2282 2297f); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); Pub. L. 95-601, sec. 10, 92 Stat.
2951 (42 U.S.C. 5851).
8. Section 19.2 is revised to read as follows:
Sec. 19.2 Scope.
The regulations in this part apply to all persons who receive,
possess, use, or transfer material licensed by the Nuclear Regulatory
Commission pursuant to the regulations in Parts 30 through 36, 39, 40,
60, 61, 63, 70, or Part 72 of this chapter, including persons licensed
to operate a production or utilization facility pursuant to Part 50 of
this chapter, persons licensed to possess power reactor spent fuel in
an independent spent fuel storage installation (ISFSI) pursuant to Part
72 of this chapter, and in accordance with Sec. 76.60 to persons
required to obtain a certificate of compliance or an approved
compliance plan under Part 76 of this chapter. The regulations
regarding interviews of individuals under subpoena apply to all
investigations and inspections within the jurisdiction of the Nuclear
Regulatory Commission other than those involving NRC employees or NRC
contractors. The regulations in this part do not apply to subpoenas
issued pursuant to 10 CFR 2.720.
9. Section 19.3 is amended by revising the definition of License to
read as follows:
Sec. 19.3 Definitions.
* * * * *
License means a license issued under the regulations in Parts 30
through 36, 39, 40, 60, 61, 63, 70, or 71 of this chapter, including
licenses to operate a production or utilization facility pursuant to
Part 50 of this chapter.
* * * * *
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
10. The authority citation for Part 20 continues to read as
follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701,
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 133,
2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
11. Section 20.1002 is revised to read as follows:
Sec. 20.1002 Scope.
The regulations in this part apply to persons licensed by the
Commission to receive, possess, use, transfer, or dispose of byproduct,
source, or special nuclear material, or to operate a production or
utilization facility under Parts 30 through 36, 39, 40, 60, 61, 63, 70,
or 72 of this chapter, and in accordance with 10 CFR 76.60 to persons
required to obtain a certificate of compliance or an approved
compliance plan under Part 76 of this chapter. The limits in this part
do not apply to doses due to background radiation, to exposure of
patients to radiation for the purpose of medical diagnosis or therapy,
to exposure from individuals administered radioactive material and
released in accordance with Sec. 35.75, or to exposure from voluntary
participation in medical research programs.
PART 21--REPORTING OF DEFECTS AND NONCOMPLIANCE
12. The authority citation for Part 21 continues to read as
follows:
Authority: Sec. 161, 68 Stat. 948, as amended, sec. 234, 83,
Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2953 (42 U.S.C.
2201, 2282, 2297f); secs. 201, as amended, 206, 88 Stat. 1242, as
amended 1246 (42 U.S.C. 5841, 5846).
Section 21.2 also issued under secs. 135, 141, Pub. L. 97-425, 96
Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
13. Section 21.2 is amended by revising paragraph (a) to read as
follows:
Sec. 21.2 Scope.
(a) The regulations in this part apply, except as specifically
provided otherwise in Parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or Part
72 of this chapter, to each individual, partnership, corporation, or
other entity licensed pursuant to the regulations in this chapter to
possess, use, or transfer within the United States source material,
byproduct material, special nuclear material, and/or spent fuel and
high level radioactive waste, or to construct, manufacture, possess,
own, operate or transfer within the United States, any production or
utilization facility or independent spent fuel storage installation
(ISFSI) or monitored retrievable storage installation (MRS); and to
each director and responsible officer of such a licensee. The
regulations in this part apply also to each individual, corporation,
partnership, or other entity doing business within the United States,
and each director and responsible officer of such organization, that
constructs a production or utilization facility licensed for the
manufacture, construction, or operation pursuant to Part 50 of this
chapter, an ISFSI for the storage of spent fuel licensed pursuant to
Part 72 of this chapter, an MRS for the storage of spent fuel or high
level radioactive waste pursuant to Part 72 of this chapter, or a
geologic repository for the disposal of high-level radioactive waste
under Parts 60 or 63 of this chapter; or supplies basic components for
a facility or activity licensed, other than for export, under Parts 30,
40, 50, 60, 61, 63, 70, 71, or Part 72 of this chapter.
Sec. 21.3 [Amended]
14. Section 21.3 is amended by adding the number 63 after ``10 CFR
Parts 30, 40, 50 (other than nuclear power plants), 61'' in paragraph
(2) in the definition of basic components, commercial grade item,
dedication, and in the definition of substantial safety hazard between
``61'' and ``70''.
15. Section 21.21 is amended by revising paragraphs (d)(1)(i) and
(d)(1)(ii) to read as follows:
Sec. 21.21 Notification of failure to comply or existence of a defect
and its evaluation.
* * * * *
(d)(1) * * *
(i) The construction or operation of a facility or an activity
within the United States that is subject to the licensing requirements
under Parts 30, 40, 50, 60, 61, 63, 70, or 72 of this chapter and that
is within his or her organization's responsibility; or
(ii) A basic component that is within his or her organization's
responsibility and is supplied for a facility or an activity within the
United States that is subject to the licensing requirements under Parts
30, 40, 50, 60, 61, 63, 70, or 72 of this chapter.
* * * * *
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
16. The authority citation for Part 30 continues to read as
follows:
Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948,
953, 954, 955, as amended, sec. 234, 83 Stat. 444 as amended (42
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246(42 U.S.C.
5841, 5842, 5846).
[[Page 8662]]
Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951 (42 U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 69
Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
17. Section 30.11 is amended by revising paragraph (c) to read as
follows:
Sec. 30.11 Specific exemptions.
* * * * *
(c) The DOE is exempt from the requirements of this part to the
extent that its activities are subject to the requirements of Parts 60
or 63 of this chapter.
* * * * *
PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL
18. The authority citation for Part 40 continues to read as
follows:
Authority: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68
Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2),
83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234,
83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094,
2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274,
Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L.
97-415, 96 Stat. 2067 (42 U.S.C. 2022).
Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951 (42 U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68
Stat. 939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184,
68 Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued
under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
19. Section 40.14 is amended by revising paragraph (c) to read as
follows:
Sec. 40.14 Specific exemptions.
* * * * *
(c) The DOE is exempt from the requirements of this part to the
extent that its activities are subject to the requirements of Parts 60
or 63 of this chapter.
* * * * *
PART 51--ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC
LICENSING AND RELATED REGULATORY FUNCTIONS
20. The authority citation for Part 51 continues to read as
follows:
Authority: Sec. 161, 68 Stat. 948, as amended, sec. 1701, 106
Stat. 2951, 2952, 2953, (42 U.S.C. 2201, 2297f); secs. 201, as
amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841,
5842). Subpart A also issued under National Environmental Policy Act
of 1969, secs. 102, 104, 105, 83 Stat. 853-854, as amended (42
U.S.C. 4332, 4334, 4335); and Pub. L. 95-604, Title II, 92 Stat.
3033-3041; and sec. 193, Pub. L. 101-575, 104 Stat. 2835 (42 U.S.C.
2243). Sections 51.20, 51.30 51.60, 51.61, 51.80, and 51.97 also
issued under secs 135, 141, Pub. L. 97-425, 96 Stat, 2232, 2241, and
sec. 148, Pub. L. 100-203, 101 Stat. 1330-223 (42 U.S.C. 10155,
10161, 10168). Section 51.22 also issued under sec. 274, 73 Stat.
688, as amended by 92 Stat. 3036-3038 (42 U.S.C. 2021 and under
Nuclear Waste Policy Act of 1982, sec. 121, 96 Stat. 2228 (42 U.S.C.
10141). Sections 51.43, 51.67, and 51.109 also issued under Nuclear
Waste Policy Act of 1982, sec 114(f), 96 Stat, 2216, as amended (42
U.S.C. 10134 (f)).
21. Section 51.20 is amended by revising paragraph (b)(13) to read
as follows:
Sec. 51.20 Criteria for and identification of licensing and regulatory
actions requiring environmental impact statements.
* * * * *
(b) * * *
(13) Issuance of a construction authorization and license pursuant
to Parts 60 or 63 of this chapter.
* * * * *
22. Section 51.22 is amended by revising paragraphs (c)(3),
(c)(10), and (d) to read as follows:
Sec. 51.22 Criteria for categorical exclusion; identification of
licensing and regulatory actions eligible for categorical exclusion or
otherwise not requiring environmental review.
* * * * *
(c) * * *
(3) Amendments to Parts 20, 30, 31, 32, 33, 34, 35, 39, 40, 50, 51,
54, 60, 61, 63, 70, 71, 72, 73, 74, 81, and 100 of this chapter which
relate to--
* * * * *
(10) Issuance of an amendment to a permit or license pursuant to
Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, 50, 60, 61, 63, 70, or Part
72 of this chapter which--
(i) Changes surety, insurance and/or indemnity requirements; or
(ii) Changes recordkeeping, reporting, or administrative procedures
or requirements.
* * * * *
(d) In accordance with Section 121 of the Nuclear Waste Policy Act
of 1982 (42 U.S.C. 10141), the promulgation of technical requirements
and criteria that the Commission will apply in approving or
disapproving applications under Parts 60 or 63 of this chapter shall
not require an environmental impact statement, an environmental
assessment, or any environmental review under subparagraph (E) or (F)
of section 102(2) of NEPA.
23. Section 51.26 is amended by revising paragraph (c) to read as
follows:
Sec. 51.26 Requirement to publish notice of intent and conduct scoping
process.
* * * * *
(c) Upon receipt of an application and accompanying environmental
impact statement under Sec. 60.22 or Sec. 63.22 of this chapter
(pertaining to geologic repositories for high-level radioactive waste),
the appropriate NRC staff director will include in the notice of
docketing required to be published by Sec. 2.101(f)(8) of this chapter
a statement of Commission intention to adopt the environmental impact
statement to the extent practicable. However, if the appropriate NRC
staff director determines, at the time of such publication or at any
time thereafter, that NRC should prepare a supplemental environmental
impact statement in connection with the Commission's action on the
license application, the procedures set out in paragraph (a) of this
section shall be followed.
24. Section 51.67 is amended by revising paragraphs (a) and (b) to
read as follows:
Sec. 51.67 Environmental information concerning geologic repositories.
(a) In lieu of an environmental report, the Department of Energy,
as an applicant for a license or license amendment pursuant to Parts 60
or 63 of this chapter, shall submit to the Commission any final
environmental impact statement which the department prepares in
connection with any geologic repository developed under Subtitle A of
Title I, or under Title IV, of the Nuclear Waste Policy Act of 1982, as
amended. (See Sec. 60.22 or Sec. 63.22 of this chapter as to required
time and manner of submission.) The statement shall include, among the
alternatives under consideration, denial of a license or construction
authorization by the Commission.
(b) Under applicable provisions of law, the Department of Energy
may be required to supplement its final environmental impact statement
if it makes a substantial change in its proposed action that is
relevant to environmental concerns or determines that there are
significant new circumstances or information relevant to environmental
concerns and bearing on the proposed action or its impacts. The
Department shall submit any supplement to its final environmental
impact statement to the Commission. (See Sec. 60.22 or Sec. 63.22 of
this chapter as
[[Page 8663]]
to required time and manner of submission.)
* * * * *
PART 60--DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC
REPOSITORIES
25. The authority citation for Part 60 continues to read as
follows:
Authority: Secs. 51, 53, 62, 63, 65, 81, 161, 182, 183, 68 Stat.
929, 930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2071,
2073, 2092, 2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88
Stat.1244, 1246 (42 U.S.C. 5842, 5846); secs. 10 and 14, Pub. L. 95-
601, 92 Stat. 2951 (42 U.S.C. 2021a and 5851); sec. 102, Pub. L. 91-
190, 83 Stat. 853 (42 U.S.C. 4332); secs. 114, 121, Pub. L. 97-425,
96 Stat. 2213g, 2238, as amended (42 U.S.C. 10134, 10141), and Pub.
L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851).
26. Section 60.1 is revised to read as follows:
Sec. 60.1 Purpose and scope.
This part prescribes rules governing the licensing of the U.S.
Department of Energy to receive and possess source, special nuclear,
and byproduct material at a geologic repository operations area sited,
constructed, or operated in accordance with the Nuclear Waste Policy
Act of 1982. This part does not apply to any activity licensed under
another part of this chapter. This part does not apply to the licensing
of the U.S. Department of Energy to receive and possess source, special
nuclear, and byproduct material at a geologic repository operations
area sited, constructed, or operated at Yucca Mountain, Nevada, in
accordance with the Nuclear Waste Policy Act of 1982, as amended, and
the Energy Policy Act of 1992, subject to Part 63 of this chapter. This
part also gives notice to all persons who knowingly provide to any
licensee, applicant, contractor, or subcontractor, components,
equipment, materials, or other goods or services, that relate to a
licensee's or applicant's activities subject to this part, that they
may be individually subject to NRC enforcement action for violation of
Sec. 60.11.
PART 61--LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE
WASTE
27. The authority citation for Part 61 continues to read as
follows:
Authority: Secs. 53, 57, 62, 63, 65, 81, 161, 182, 183, 68 Stat.
930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2073, 2077,
2092, 2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88 Stat.
1244, 1246, (42 U.S.C. 5842, 5846); secs. 10 and 14, Pub. L. 95-601,
92 Stat. 2951 (42 U.S.C. 2021a and 5851) and Pub. L. 102-486, sec.
2902, 106 Stat. 3123, (42 U.S.C. 5851).
28. Section 61.1 is amended by revising paragraph (b) to read as
follows:
Sec. 61.1 Purpose and scope.
* * * * *
(b) Except as provided in Part 150 of this chapter, which addresses
assumption of certain regulatory authority by Agreement States, and
Sec. 61.6 ``Exemptions,'' the regulations in this part apply to all
persons in the United States. The regulations in this part do not apply
to--
(1) Disposal of high-level waste as provided for in Parts 60 or 63
of this chapter;
(2) Disposal of uranium or thorium tailings or wastes (byproduct
material as defined in Sec. 40.4 (a-1) as provided for in Part 40 of
this chapter in quantities greater than 10,000 kilograms and containing
more than 5 millicuries of radium-226; or
(3) Disposal of licensed material as provided for in Part 20 of
this chapter.
* * * * *
29. In Section 61.2, the definition of Land disposal facility is
revised to read as follows:
Sec. 61.2 Definitions.
* * * * *
Land disposal facility means the land, building, and structures,
and equipment which are intended to be used for the disposal of
radioactive wastes. For purposes of this chapter, a ``geologic
repository'' as defined in Parts 60 or 63 is not considered a land
disposal facility.
* * * * *
30. Section 61.55 is amended by revising paragraph (a)(2)(iv) to
read as follows:
Sec. 61.55 Waste classification.
(a) * * *
(2) * * *
(iv) Waste that is not generally acceptable for near-surface
disposal is waste for which form and disposal methods must be
different, and in general more stringent, than those specified for
Class C waste. In the absence of specific requirements in this part,
such waste must be disposed of in a geologic repository as defined in
Parts 60 or 63 of this chapter unless proposals for disposal of such
waste in a disposal site licensed pursuant to this part are approved by
the Commission.
* * * * *
31. Part 63 is added to read as follows:
PART 63--DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC
REPOSITORY AT YUCCA MOUNTAIN, NEVADA
Subpart A--General Provisions
Sec.
63.1 Purpose and scope.
63.2 Definitions.
63.3 License required.
63.4 Communications and records.
63.5 Interpretations.
63.6 Exemptions.
63.7 License not required for certain preliminary activities.
63.8 Information collection requirements: OMB Approval.
63.9 Employee protection.
63.10 Completeness and accuracy of information.
63.11 Deliberate misconduct.
Subpart B--Licenses
PREAPPLICATION REVIEW
63.15 Site characterization.
63.16 Review of site characterization activities.
LICENSE APPLICATION
63.21 Content of application.
63.22 Filing and distribution of application.
63.23 Elimination of repetition.
63.24 Updating of application and environmental impact statement.
CONSTRUCTION AUTHORIZATION
63.31 Construction authorization.
63.32 Conditions of construction authorization.
63.33 Amendment of construction authorization.
LICENSE ISSUANCE AND AMENDMENT
63.41 Standards for issuance of a license.
63.42 Conditions of license.
63.43 License specification.
63.44 Changes, tests, and experiments.
63.45 Amendment of license.
63.46 Particular activities requiring license amendment.
PERMANENT CLOSURE
63.51 License amendment for permanent closure.
63.52 Termination of license.
Subpart C--Participation by State Government and Affected Indian Tribes
63.61 Provision of information.
63.62 Site review.
63.63 Participation in license reviews.
63.64 Notice to State.
63.65 Representation.
Subpart D--Records, Reports, Tests, and Inspections
63.71 Records and reports.
63.72 Construction records.
63.73 Reports of deficiencies.
63.74 Tests.
63.75 Inspections.
63.78 Material control and accounting records and reports.
[[Page 8664]]
Subpart E--Technical Criteria
63.101 Purpose and nature of findings.
63.102 Concepts.
PERFORMANCE OBJECTIVES
63.111 Performance objectives for the geologic repository
operations area through permanent closure.
INTEGRATED SAFETY ANALYSIS
63.112 Requirements for integrated safety analysis of the geologic
repository operations area.
63.113 Performance objective for the geologic repository after
permanent closure.
PERFORMANCE ASSESSMENT
63.114 Requirements for performance assessment.
CHARACTERISTICS OF THE REFERENCE BIOSPHERE AND CRITICAL GROUP
63.115 Required characteristics of the reference biosphere and
critical group.
LAND OWNERSHIP AND CONTROL
63.121 Requirements for ownership and control of interests in land.
Subpart F--Performance Confirmation Program
63.131 General requirements.
63.132 Confirmation of geotechnical and design parameters.
63.133 Design testing.
63.134 Monitoring and testing waste packages.
Subpart G--Quality Assurance
63.141 Scope.
63.142 Applicability.
63.143 Implementation.
Subpart H--Training and Certification of Personnel
63.151 General requirements.
63.152 Training and certification program.
63.153 Physical requirements.
Subpart I--Emergency Planning Criteria
63.161 Emergency plan for the geologic repository operations area
through permanent closure.
Subpart J--Violations
63.171 Violations.
63.172 Criminal penalties.
Authority: Secs. 51, 53, 62, 63, 65, 81, 161, 182, 183, 68 Stat.
929, 930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2071,
2073, 2092, 2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88
Stat.1244, 1246 (42 U.S.C. 5842, 5846); secs. 10 and 14, Pub. L. 95-
601, 92 Stat. 2951 (42 U.S.C. 2021a and 5851); sec. 102, Pub. L. 91-
190, 83 Stat. 853 (42 U.S.C. 4332); secs. 114, 121, Pub. L. 97-425,
96 Stat. 2213g, 2238, as amended (42 U.S.C. 10134, 10141), and Pub.
L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851).
Subpart A--General Provisions
Sec. 63.1 Purpose and scope.
This part prescribes rules governing the licensing of the U.S.
Department of Energy to receive and possess source, special nuclear,
and byproduct material at a geologic repository operations area sited,
constructed, or operated at Yucca Mountain, Nevada, in accordance with
the Nuclear Waste Policy Act of 1982, as amended, and the Energy Policy
Act of 1992. As provided in Sec. 60.1, ``Purpose and scope,'' the
regulations in Part 60 of this chapter do not apply to any activity
that is subject to licensing under this part. This part does not apply
to any activity licensed under another part of this chapter. This part
also gives notice to all persons who knowingly provide, to any
licensee, applicant, contractor, or subcontractor, components,
equipment, materials, or other goods or services, that relate to a
licensee's or applicant's activities subject to this part, that they
may be individually subject to NRC enforcement action for violation of
Sec. 63.11.
Sec. 63.2 Definitions.
As used in this part:
Affected Indian Tribe means any Indian Tribe within whose
reservation boundaries a repository for high-level radioactive waste or
spent fuel is proposed to be located; or whose Federally defined
possessory or usage rights to other lands outside of the reservation's
boundaries arising out of Congressionally ratified treaties or other
Federal law may be substantially and adversely affected by the locating
of such a facility; Provided, that the Secretary of the Interior finds,
on the petition of the appropriate governmental officials of the Tribe,
that such effects are both substantial and adverse to the Tribe.
Annual dose means the total effective dose equivalent (TEDE as
defined at Sec. 20.1003) received in a single year by the average
member of the critical group only as a result of radioactive materials
released from the geologic repository.
Barrier means any material or structure that prevents or
substantially delays movement of water or radioactive materials.
Commencement of construction means clearing of land, surface or
subsurface excavation, or other substantial action that would adversely
affect the environment of a site. It does not include changes desirable
for the temporary use of the land for public recreational uses, site
characterization activities, other preconstruction monitoring and
investigation necessary to establish background information related to
the suitability of the Yucca Mountain site or to the protection of
environmental values, or procurement or manufacture of components of
the geologic repository operations area.
Commission means the Nuclear Regulatory Commission or its duly
authorized representatives.
Containment means the confinement of radioactive waste within a
designated boundary.
Critical group means the hypothetical group of individuals
reasonably expected to receive the greatest exposure to radioactive
materials released from the geologic repository.
Design bases means that information that identifies the specific
functions to be performed by a structure, system, or component of a
facility and the specific values or ranges of values chosen for
controlling parameters as reference bounds for design. These values may
be restraints derived from generally accepted ``state-of-the-art''
practices for achieving functional goals or requirements derived from
analysis (based on calculation or experiments) of the effects of a
postulated event under which a structure, system, or component must
meet its functional goals. The values for controlling parameters for
external events include:
(1) Estimates of severe natural events to be used for deriving
design bases that will be based on consideration of historical data on
the associated parameters, physical data, or analysis of upper limits
of the physical processes involved; and
(2) Estimates of severe external human-induced events, to be used
for deriving design bases, that will be based on analysis of human
activity in the region, taking into account the site characteristics
and the risks associated with the event.
Design basis events means:
(1) Those natural and human-induced events that are expected to
occur one or more times before permanent closure of the geologic
repository operations area (referred to as Category 1 events); and
(2) Other natural and man-induced events that have at least one
chance in 10,000 of occurring before permanent closure of the geologic
repository (referred to as Category 2 events).
Director means the Director of the Nuclear Regulatory Commission's
Office of Nuclear Material Safety and Safeguards.
Disposal means the emplacement of radioactive wastes in a geologic
repository with the intent of leaving it there permanently.
DOE means the U.S. Department of Energy or its duly authorized
representatives.
Engineered barrier system means the waste packages and the
underground facility.
Expected annual dose means the expected value of the annual dose
[[Page 8665]]
considering the probability of the occurrence of the events and the
uncertainty, or variability, in parameter values used to describe the
behavior of the geologic repository.
Geologic repository means a system that is intended to be used for,
or may be used for, the disposal of radioactive wastes in excavated
geologic media. A geologic repository includes: The engineered barrier
system, and the portion of the geologic setting that provides isolation
of the radioactive waste.
Geologic repository operations area means a high-level radioactive
waste facility that is part of a geologic repository, including both
surface and subsurface areas, where waste handling activities are
conducted.
Geologic setting means the geologic, hydrologic, and geochemical
systems of the region in which a geologic repository is or may be
located.
Groundwater means all liquid water that occurs below the land
surface.
High-level radioactive waste or HLW means:
(1) Irradiated reactor fuel;
(2) Liquid wastes resulting from the operation of the first-cycle
solvent extraction system, or equivalent, and the concentrated wastes
from subsequent extraction cycles, or equivalent, in a facility for
reprocessing irradiated reactor fuel; and
(3) Solids into which such liquid wastes have been converted.
HLW facility means a facility subject to the licensing and related
regulatory authority of the Commission pursuant to Sections 202(3) and
202(4) of the Energy Reorganization Act of 1974 (88 Stat. 1244)
1
---------------------------------------------------------------------------
\1\ These are DOE ``facilities used primarily for the receipt
and storage of high-level radioactive wastes resulting from
activities licensed under such Act [the Atomic Energy Act]'' and
``Retrievable Surface Storage Facilities and other facilities
authorized for the express purpose of subsequent long-term storage
of high-level radioactive wastes generated by [DOE], which are not
used for, or are part of, research and development activities.''
---------------------------------------------------------------------------
Host rock means the geologic medium in which the waste is emplaced.
Important to safety, with reference to structures, systems, and
components, means those engineered features of the geologic repository
operations area whose function is:
(1) To provide reasonable assurance that high-level waste can be
received, handled, packaged, stored, emplaced, and retrieved without
exceeding the requirements of Sec. 63.111(b)(1) for Category 1 design
basis events; or
(2) To prevent or mitigate Category 2 design basis events that
could result in doses equal to or greater than the values specified in
Sec. 63.111(b)(2) to any individual located on or beyond any point on
the boundary of the site.
Important to waste isolation, with reference to design of the
engineered barrier system and characterization of natural barriers,
means those engineered and natural barriers whose function is to
provide reasonable assurance that high-level waste can be disposed
without exceeding the requirements of Sec. 63.113(b).
Integrated safety analysis means an analysis to identify hazards
and their potential for initiating event sequences, the potential event
sequences and their consequences, and the site, structures, systems,
components, equipment, and activities of personnel, that are relied on
for safety. As used here, integrated means joint consideration of
safety measures that otherwise might conflict, including, but not
limited to, integration of fire protection, radiation safety,
criticality safety, and chemical safety measures.
Isolation means inhibiting the transport of radioactive material to
the location of the critical group so that radiation exposures will not
exceed the requirements of Sec. 63.113(b).
Performance assessment means a probabilistic analysis that:
(1) Identifies the features, events and processes that might affect
the performance of the geologic repository; and
(2) Examines the effects of such features, events, and processes on
the performance of the geologic repository; and
(3) Estimates the expected annual dose to the average member of the
critical group as a result of releases from the geologic repository.
Performance confirmation means the program of tests, experiments,
and analyses that is conducted to evaluate the accuracy and adequacy of
the information used to determine with reasonable assurance that the
performance objective at Sec. 63.113(b) will be met.
Permanent closure means final backfilling of the underground
facility, if appropriate, and the sealing of shafts, ramps, and
boreholes.
Public Document Room means the place at 2120 L Street NW.,
Washington, DC, at which records of the Commission will ordinarily be
made available for public inspection and any other place, the location
of which has been published in the Federal Register, at which public
records of the Commission pertaining to a geologic repository at the
Yucca Mountain site are made available for public inspection.
Radioactive waste or waste means HLW and radioactive materials
other than HLW that are received for emplacement in a geologic
repository.
Reference biosphere means the description of the environment
inhabited by the critical group. The reference biosphere comprises the
set of specific biotic and abiotic characteristics of the environment,
including, but not necessarily limited to, climate, topography, soils,
flora, fauna, and human activities.
Restricted area means an area, access to which is limited by the
licensee for the purpose of protecting individuals against undue risks
from exposure to radiation and radioactive materials. Restricted area
does not include areas used as residential quarters, but separate rooms
in a residential building may be set aside as a restricted area.
Retrieval means the act of intentionally removing radioactive waste
from the underground location at which the waste had been previously
emplaced for disposal.
Saturated zone means that part of the earth's crust beneath the
regional water table in which all voids, large and small, are ideally
filled with water under pressure greater than atmospheric.
Site means that area surrounding the geologic repository operations
area for which DOE exercises authority over its use in accordance with
the provisions of this part.
Site characterization means the program of exploration and
research, both in the laboratory and in the field, undertaken to
establish the geologic conditions and the ranges of those parameters of
the Yucca Mountain site, and the surrounding region to the extent
necessary, relevant to the procedures under this part. Site
characterization includes borings, surface excavations, excavation of
exploratory shafts and/or ramps, limited subsurface lateral excavations
and borings, and in situ testing at depth needed to determine the
suitability of the site for a geologic repository.
Underground facility means the underground structure, backfill
materials, if any, and openings that penetrate the underground
structure (e.g., ramps, shafts, and boreholes, including their seals).
Unrestricted area means an area, access to which is neither limited
nor controlled by the licensee.
Unsaturated zone means the zone between the land surface and the
regional water table. Generally, fluid pressure in this zone is less
than atmospheric pressure, and some of the voids may contain air or
other gases at atmospheric pressure. Beneath flooded
[[Page 8666]]
areas or in perched water bodies, the fluid pressure locally may be
greater than atmospheric.
Waste form means the radioactive waste materials and any
encapsulating or stabilizing matrix.
Waste package means the waste form and any containers, shielding,
packing, and other absorbent materials immediately surrounding an
individual waste container.
Water table means that surface in a groundwater body, separating
the unsaturated zone from the saturated zone, at which the water
pressure is atmospheric.
Sec. 63.3 License required.
(a) DOE shall not receive nor possess source, special nuclear, or
byproduct material at a geologic repository operations area at the
Yucca Mountain site except as authorized by a license issued by the
Commission pursuant to this part.
(b) DOE shall not begin construction of a geologic repository
operations area at the Yucca Mountain site unless it has filed an
application with the Commission and has obtained construction
authorization as provided in this part. Failure to comply with this
requirement shall be grounds for denial of a license.
Sec. 63.4 Communications and records.
(a) Except where otherwise specified, all communications and
reports concerning the regulations in this part and applications filed
under them should be addressed to the Director of Nuclear Material
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001. Communications, reports, and applications may be
delivered in person at the Commission's offices at 2120 L Street NW,
Washington DC, or 11555 Rockville Pike, Rockville, MD.
(b) Each record required by this part must be legible throughout
the retention period specified by each Commission regulation. The
record may be the original or a reproduced copy or a microform provided
that the copy or microform is authenticated by authorized personnel and
that the microform is capable of producing a clear copy throughout the
required retention period. The record may also be stored in electronic
media with the capability for producing legible, accurate, and complete
records during the required retention period. Records such as letters,
drawings, and specifications must include all pertinent information
such as stamps, initials, and signatures. The licensee shall maintain
adequate safeguards against tampering with and loss of records.
Sec. 63.5 Interpretations.
Except as specifically authorized by the Commission in writing, no
interpretation of the meaning of the regulations in this part by any
officer or employee of the Commission other than a written
interpretation by the General Counsel will be considered binding on the
Commission.
Sec. 63.6 Exemptions.
The Commission may, upon application by DOE, any interested person,
or upon its own initiative, grant such exemptions from the requirements
of the regulations in this part as it determines are authorized by law,
will not endanger life nor property nor the common defense and
security, and are otherwise in the public interest.
Sec. 63.7 License not required for certain preliminary activities.
The requirement for a license set forth in Sec. 63.3(a) is not
applicable to the extent that DOE receives and possesses source,
special nuclear, and byproduct material at a geologic repository at the
Yucca Mountain site:
(a) For purposes of site characterization; or
(b) For use, during site characterization or construction, as
components of radiographic, radiation monitoring, or similar equipment
or instrumentation.
Sec. 63.8 Information collection requirements: OMB approval.
(a) The U.S. Nuclear Regulatory Commission has submitted the
information collection requirements of general applicability contained
in this part to the Office of Management and Budget for approval, as
required by the Paperwork Reduction Act (44 U.S.C. 3501, et seq.). The
Office of Management and Budget has approved the information collection
requirements contained in this part under control number 3150-XXXX.
(b) The approved information collection requirements contained in
this part appear in Secs. 63.62, 63.63, and 63.65.
Sec. 63.9 Employee protection.
(a) Discrimination by a Commission licensee, an applicant for a
Commission license, or a contractor or subcontractor of a Commission
licensee or applicant, against an employee, for engaging in certain
protected activities, is prohibited. Discrimination includes discharge
and other actions that relate to compensation, terms, conditions, or
privileges of employment. The protected activities are established in
Section 211 of the Energy Reorganization Act of 1974, as amended, and
in general are related to the administration or enforcement of a
requirement imposed under the Atomic Energy Act or the Energy
Reorganization Act.
(1) The protected activities include but are not limited to:
(i) Providing the Commission, or his or her employer, information
about alleged violations of either of the statutes named in paragraph
(a) of this section or possible violations of requirements imposed
under either of those aforementioned statutes;
(ii) Refusing to engage in any practice made unlawful under either
of the statutes named in paragraph (a) of this section, or under these
requirements, if the employee has identified the alleged illegality to
the employer;
(iii) Requesting the Commission to institute action against his or
her employer for the administration or enforcement of these
requirements;
(iv) Testifying in any Commission proceeding, or before Congress,
or at any Federal or State proceeding regarding any provision (or
proposed provision) of either of the statutes named in paragraph (a) of
this section;
(v) Assisting or participating in, or is about to assist or
participate in, these activities.
(2) These activities are protected even if no formal proceeding is
actually initiated as a result of the employee assistance or
participation.
(3) This section has no application to any employee alleging
discrimination prohibited by this section who, acting without direction
from his or her employer (or the employer's agent), deliberately causes
a violation of any requirement of the Energy Reorganization Act of
1974, as amended, or the Atomic Energy Act of 1954, as amended.
(b) Any employee who believes that he or she has been discharged or
otherwise discriminated against by any person for engaging in protected
activities specified in paragraph (a)(1) of this section may seek a
remedy for the discharge or discrimination through an administrative
proceeding in the Department of Labor. The administrative proceeding
must be initiated within 180 days after an alleged violation occurs.
The employee may do this by filing a complaint alleging the violation
with the Department of Labor, Employment Standards Administration, Wage
and Hour Division. The Department of Labor may order reinstatement,
back pay, and compensatory damages.
[[Page 8667]]
(c) A violation of paragraph (a), (e), or (f) of this section by a
Commission licensee, an applicant for a Commission license, or a
contractor or subcontractor of a Commission licensee or applicant may
be grounds for--
(1) Denial, revocation, or suspension of the license.
(2) Imposition of a civil penalty on the licensee or applicant.
(3) Other enforcement action.
(d) Actions taken by an employer, or others, that adversely affect
an employee, may be predicated on nondiscriminatory grounds. The
prohibition applies when the adverse action occurs because the employee
has engaged in protected activities. An employee's engagement in
protected activities does not automatically render him or her immune
from discharge or discipline for legitimate reasons or from adverse
action dictated by nonprohibited considerations.
(e)(1) Each licensee and each applicant for a license shall
prominently post the revision of NRC Form 3, ``Notice to Employees,''
referenced in Sec. 19.11(c) of this chapter. This form must be posted
at locations sufficient to permit employees protected by this section
to observe a copy on the way to or from their place of work. Premises
must be posted not later than 30 days after an application is docketed
and remain posted while the application is pending before the
Commission, during the term of the license, and for 30 days following
license termination.
(2) Copies of NRC Form 3 may be obtained by writing to the Regional
Administrator of the appropriate U.S. Nuclear Regulatory Commission
Regional Office listed in Appendix D to Part 20 of this chapter or by
accessing the NRC Web Site www.nrc.gov/NRC/FORMS/forms3.html.
(f) No agreement affecting the compensation, terms, conditions, or
privileges of employment, including an agreement to settle a complaint
filed by an employee with the Department of Labor pursuant to Section
211 of the Energy Reorganization Act of 1974, as amended, may contain
any provision that would prohibit, restrict, or otherwise discourage an
employee from participating in protected activity as defined in
paragraph (a)(1) of this section including, but not limited to,
providing information to NRC or to his or her employer on potential
violations or other matters within NRC's regulatory responsibilities.
Sec. 63.10 Completeness and accuracy of information.
(a) Information provided to the Commission by an applicant for a
license or by a licensee, or information required by statute, or
required by the Commission's regulations, orders, or license conditions
to be maintained by the applicant or the licensee shall be complete and
accurate in all material respects.
(b) The applicant or licensee shall notify the Commission of
information identified by the applicant or licensee as having, for the
regulated activity, a significant implication for public health and
safety or common defense and security. An applicant or licensee
violates this paragraph only if the applicant or licensee fails to
notify the Commission of information that the applicant or licensee has
identified as having a significant implication for public health and
safety or common defense and security. Notification shall be provided
to the Administrator of the appropriate Regional Office within 2
working days of identifying the information. This requirement is not
applicable to information that is already required to be provided to
the Commission by other reporting or updating requirements.
Sec. 63.11 Deliberate misconduct.
(a) Any licensee, applicant for a license, employee of a licensee
or applicant; or any contractor (including a supplier or consultant),
subcontractor, employee of a contractor or subcontractor of any
licensee or applicant for a license, who knowingly provides to any
licensee, applicant, contractor, or subcontractor, any components,
equipment, materials, or other goods or services that relate to a
licensee's or applicant's activities in this part, may not:
(1) Engage in deliberate misconduct that causes or would have
caused, if not detected, a licensee or applicant to be in violation of
any rule, regulation, or order; or any term, condition, or limitation
of any license issued by the Commission; or
(2) Deliberately submit to NRC, a licensee, an applicant, or a
licensee's or applicant's contractor or subcontractor, information that
the person submitting the information knows to be incomplete or
inaccurate in some respect material to NRC.
(b) A person who violates paragraph (a)(1) or (a)(2) of this
section may be subject to enforcement action in accordance with the
procedures in 10 CFR Part 2, Subpart B.
(c) For purposes of paragraph (a)(1) of this section, deliberate
misconduct by a person means an intentional act or omission that the
person knows:
(1) Would cause a licensee or applicant to be in violation of any
rule, regulation, or order; or any term, condition, or limitation, of
any license issued by the Commission; or
(2) Constitutes a violation of a requirement, procedure,
instruction, contract, purchase order, or policy of a licensee,
applicant, contractor, or subcontractor.
Subpart B--Licenses
PREAPPLICATION REVIEW
Sec. 63.15 Site characterization.
(a) Before submittal of an application for a license to be issued
under this part, DOE shall conduct a program of site characterization
with respect to the Yucca Mountain site.
(b) Investigations to obtain the required information shall be
conducted in such a manner as to limit, to the extent practical,
adverse effects on the long-term performance of the geologic repository
at Yucca Mountain.
Sec. 63.16 Review of site characterization activities.2
---------------------------------------------------------------------------
\2\ In addition to the review of site characterization
activities specified in this section, the Commission contemplates an
ongoing review of other information on site investigation and site
characterization, to allow early identification of potential
licensing issues for timely resolution.
---------------------------------------------------------------------------
(a) If DOE's planned site characterization activities include
onsite testing with radioactive material, including radioactive
tracers, the Commission shall determine whether the proposed use of
such radioactive material is necessary to provide data for the
preparation of the environmental reports required by law and for an
application to be submitted under Sec. 63.22.
(b) During the conduct of site characterization activities at the
Yucca Mountain site, DOE shall report not less than once every 6 months
to the Commission on the nature and extent of such activities and the
information that has been developed, and on the progress of waste form
and waste package research and development. The semiannual reports
shall include the results of site characterization studies, the
identification of new issues, plans for additional studies to resolve
new issues, elimination of planned studies no longer necessary,
identification of decision points reached, and modifications to
schedules, where appropriate. DOE shall also report its progress in
developing the design of a geologic repository operations area
appropriate for the area being characterized, noting when key design
parameters or features that depend on the results of site
characterization will be established. Other topics related to
[[Page 8668]]
site characterization shall also be covered if requested by the
Director.
(c) During the conduct of site characterization activities at the
Yucca Mountain site, NRC staff shall be permitted to visit and inspect
the locations at which such activities are carried out and to observe
excavations, borings, and in-situ tests, as they are done.
(d) The Director may comment at any time in writing to DOE,
expressing current views on any aspect of site characterization or
performance assessment at the Yucca Mountain site. In particular, such
comments shall be made whenever the Director determines that there are
substantial grounds for making recommendations or stating objections to
DOE's site characterization program. The Director shall invite public
comment on any comments that the Director makes to DOE, on review of
the DOE semiannual reports, or on any other comments that the Director
makes to DOE on site characterization and performance assessment.
(e) The Director shall transmit copies of all comments to DOE made
by the Director under this section to the Governor and legislature of
the State of Nevada and to the governing body of any affected Indian
Tribe.
(f) All correspondence between DOE and NRC, under this section,
including the reports described in paragraph (b) of this section, shall
be placed in the Public Document Room.
(g) The activities described in paragraphs (a) through (f) of this
section constitute informal conference between a prospective applicant
and the NRC staff, as described in Sec. 2.101(a)(1) of this chapter,
and are not part of a proceeding under the Atomic Energy Act of 1954,
as amended. Accordingly, the issuance of the Director's comments made
under this section does not constitute a commitment to issue any
authorization or license, or in any way affect the authority of the
Commission, Atomic Safety and Licensing Boards, other presiding
officers, or the Director, in any such proceeding.
LICENSE APPLICATION
Sec. 63.21 Content of application.
(a) An application shall consist of general information and a
Safety Analysis Report. An environmental impact statement shall be
prepared in accordance with the Nuclear Waste Policy Act of 1982, as
amended, and shall accompany the application. Any Restricted Data or
National Security Information shall be separated from unclassified
information.
(b) The general information shall include:
(1) A general description of the proposed geologic repository at
the Yucca Mountain site, identifying the location of the geologic
repository operations area, the general character of the proposed
activities, and the basis for the exercise of the Commission's
licensing authority.
(2) Proposed schedules for construction, receipt of waste, and
emplacement of wastes at the proposed geologic repository operations
area.
(3) A detailed plan to provide physical protection of high-level
radioactive waste in accordance with Sec. 73.51 of this chapter. This
plan must include the design for physical protection, the licensee's
safeguards contingency plan, and security organization personnel
training and qualification plan. The plan must list tests, inspections,
audits, and other means to be used to demonstrate compliance with such
requirements.
(4) A description of the material control and accounting program to
meet the requirements of Sec. 63.78.
(5) A description of work conducted to characterize the Yucca
Mountain site.
(c) The Safety Analysis Report shall include:
(1) A description of the Yucca Mountain site, with appropriate
attention to those features, events, and processes of the site that
might affect design of the geologic repository operations area and
performance of the geologic repository. The description of the site
shall include information regarding features, events, and processes
outside of the site to the extent the information is relevant and
material to safety or performance of the geologic repository. The
information referred to in this paragraph shall include:
(i) The location of the geologic repository operations area with
respect to the boundary of the site;
(ii) Information regarding the geology, hydrology, and geochemistry
of the site, including geomechanical properties and conditions of the
host rock;
(iii) Information regarding surface water hydrology, climatology,
and meteorology of the site;
(iv) Information regarding the location of the critical group, and
regarding local human behaviors and characteristics, as needed to
support selection of conceptual models and parameters used for the
reference biosphere and critical group.
(2) An integrated safety analysis of the geologic repository
operations area, for the period before permanent closure, to ensure
compliance with Sec. 63.111(a), as required by Sec. 63.111(c). For the
purposes of this analysis, it shall be assumed that operations at the
geologic repository operations area will be carried out at the maximum
capacity and rate of receipt of radioactive waste stated in the
application.
(3) Information relative to materials of construction of the
geologic repository operations area (including geologic media, general
arrangement, and approximate dimensions), and codes and standards that
DOE proposes to apply to the design and construction of the geologic
repository operations area.
(4) A description and discussion of the design of the engineered
barrier system including:
(i) The principal design criteria and their relationships to the
postclosure performance objective specified at Sec. 63.113(b); and
(ii) The design bases and their relation to the principal design
criteria.
(5) An assessment to determine the degree to which those features,
events, and processes of the site that are expected to materially
affect compliance with Sec. 63.113(b)--whether beneficial or
potentially adverse to performance of the geologic repository--have
been characterized, and the extent to which they affect waste
isolation. Investigations shall extend from the surface to a depth
sufficient to determine principal pathways for radionuclide migration
from the underground facility. Specific features, events, and processes
of the geologic setting shall be investigated outside of the site if
they affect performance of the geologic repository.
(6) An assessment of the anticipated response of the geomechanical,
hydrogeologic, and geochemical systems to the range of design thermal
loadings under consideration, given the pattern of fractures and other
discontinuities and the heat transfer properties of the rock mass and
groundwater.
(7) An assessment of the performance of the proposed geologic
repository for the period after permanent closure, as required by
Sec. 63.113(c). The assessment shall also include a comparative
evaluation of alternatives to the major design features that are
important to waste isolation, with particular attention to the
alternatives that would provide longer containment and isolation of
radioactive materials.
(8) An assessment of the ability of the proposed geologic
repository to limit radiological exposures in the event of limited
human intrusion into the engineered barrier system as required by
Sec. 63.113(d).
(9) An explanation of measures used to support the models used to
perform the assessments required in paragraphs (c)(5) through (c)(8) of
this section. Analyses and models that will be used
[[Page 8669]]
to assess performance of the geologic repository shall be supported by
using an appropriate combination of such methods as field tests, in-
situ tests, laboratory tests that are representative of field
conditions, monitoring data, and natural analog studies.
(10) An explanation of how expert elicitation was used in the
assessments required in paragraphs (c)(5) through (c)(8) of this
section.
(11) A description of the quality assurance program to be applied
to the structures, systems, and components important to safety and to
the engineered and natural barriers important to waste isolation.
(12) A description of the kind, amount, and specifications of the
radioactive material proposed to be received and possessed at the
geologic repository operations area at the Yucca Mountain site.
(13) An identification and justification for the selection of those
variables, conditions, or other items that are determined to be
probable subjects of license specifications. Special attention shall be
given to those items that may significantly influence the final design.
(14) A description of the program for control and monitoring of
radioactive effluents and occupational radiation exposures to maintain
such effluents and exposures in accordance with the requirements of
Sec. 63.111.
(15) A description of the controls that DOE will apply to restrict
access and to regulate land use at the Yucca Mountain site and adjacent
areas, including a conceptual design of monuments that would be used to
identify the site after permanent closure.
(16) A description of the plan for responding to, and recovering
from, radiological emergencies that may occur at any time before
permanent closure and decontamination or dismantlement of surface
facilities, as required by Sec. 63.161.
(17) A description of the program to be used to maintain the
records described in Secs. 63.71 and 63.72.
(18) A description of design considerations that are intended to
facilitate permanent closure and decontamination or dismantlement of
surface facilities.
(19) A description of plans for retrieval and alternate storage of
the radioactive wastes, should retrieval be necessary.
(20) A description of the performance confirmation program that
meets the requirements of Subpart F.
(21) An identification of those structures, systems, and components
of the geologic repository, both surface and subsurface, which require
research and development to confirm the adequacy of design. For
structures, systems, and components important to safety and for the
engineered and natural barriers important to waste isolation, DOE shall
provide a detailed description of the programs designed to resolve
safety questions, including a schedule indicating when these questions
would be resolved.
(22) The following information concerning activities at the
geologic repository operations area:
(i) The organizational structure of DOE as it pertains to
construction and operation of the geologic repository operations area,
including a description of any delegations of authority and assignments
of responsibilities, whether in the form of regulations, administrative
directives, contract provisions, or otherwise.
(ii) Identification of key positions that are assigned
responsibility for safety at and operation of the geologic repository
operations area.
(iii) Personnel qualifications and training requirements.
(iv) Plans for startup activities and startup testing.
(v) Plans for conduct of normal activities, including maintenance,
surveillance, and periodic testing of structures, systems, and
components of the geologic repository operations area.
(vi) Plans for permanent closure and plans for the decontamination
or dismantlement of surface facilities.
(vii) Plans for any uses of the geologic repository operations area
at the Yucca Mountain site for purposes other than disposal of
radioactive wastes, with an analysis of the effects, if any, that such
uses may have on the operation of the structures, systems, and
components important to safety and the engineered and natural barriers
important to waste isolation.
Sec. 63.22 Filing and distribution of application.
(a) An application for a license to receive and possess source,
special nuclear, or byproduct material at a geologic repository
operations area, at the Yucca Mountain site, that has been
characterized, and any amendments thereto, and an accompanying
environmental impact statement and any supplements, shall be signed by
the Secretary of Energy or the Secretary's authorized representative
and shall be filed in triplicate with the Director.
(b) Each portion of such application and any amendments, and each
environmental impact statement and any supplements, shall be
accompanied by 30 additional copies. Another 120 copies shall be
retained by DOE for distribution in accordance with written
instructions from the Director or the Director's designee.
(c) DOE shall, on notification of the appointment of an Atomic
Safety and Licensing Board, update the application, eliminating all
superseded information, and supplement the environmental impact
statement if necessary, and serve the updated application and
environmental impact statement (as it may have been supplemented) as
directed by the Board. Any subsequent amendments to the application or
supplements to the environmental impact statement shall be served in
the same manner.
(d) At the time of filing of an application and any amendments
thereto, copies shall be made available in appropriate locations near
the proposed geologic repository operations area at the Yucca Mountain
site, for inspection by the public, and updated as amendments to the
application are made. The environmental impact statement and any
supplements thereto shall be made available in the same manner. An
updated copy of the application, and the environmental impact statement
and supplements, shall be produced at any public hearing held by the
Commission on the application, for use by any party to the proceeding.
(e) DOE shall certify that the updated copies of the application,
and the environmental impact statement as it may have been
supplemented, as referred to in paragraphs (c) and (d) of this section,
contain the current contents of such documents submitted in accordance
with the requirements of this part.
Sec. 63.23 Elimination of repetition.
In its application or environmental impact statement, DOE may
incorporate, by reference, information contained in previous
applications, statements, or reports filed with the Commission,
provided, that such references are clear and specific and that copies
of the information so incorporated are made available to the public
locations near the site of the proposed geologic repository, as
provided pursuant to Sec. 63.22(d).
Sec. 63.24 Updating of application and environmental impact statement.
(a) The application shall be as complete as possible in the light
of information that is reasonably available at the time of docketing.
(b) DOE shall update its application in a timely manner so as to
permit the Commission to review, before issuance of a license:
[[Page 8670]]
(1) Additional geologic, geophysical, geochemical, hydrologic,
meteorologic, materials, design, and other data obtained during
construction.
(2) Conformance of construction of structures, systems, and
components with the design.
(3) Results of research programs carried out to confirm the
adequacy of designs, conceptual models, parameter values, and estimates
of performance of the geologic repository.
(4) Other information bearing on the Commission's issuance of a
license that was not available at the time a construction authorization
was issued.
(c) DOE shall supplement its environmental impact statement in a
timely manner so as to take into account the environmental impacts of
any substantial changes in its proposed actions or any significant new
circumstances or information relevant to environmental concerns bearing
on the proposed action or its impacts.
CONSTRUCTION AUTHORIZATION
Sec. 63.31 Construction authorization.
On review and consideration of an application and environmental
impact statement submitted under this part, the Commission may
authorize construction of a geologic repository operations area at the
Yucca Mountain site if it determines:
(a) Safety. That there is reasonable assurance that the types and
amounts of radioactive materials described in the application can be
received, possessed, and disposed of in a geologic repository
operations area of the design proposed without unreasonable risk to the
health and safety of the public. In arriving at this determination, the
Commission shall consider whether:
(1) DOE has described the proposed geologic repository as specified
at Sec. 63.21.
(2) The site and design comply with the performance objectives and
requirements contained in Subpart E of this part.
(3) DOE's quality assurance program complies with the requirements
of Subpart G of this part.
(4) DOE's personnel training program complies with the criteria
contained in Subpart H of this part.
(5) DOE's emergency plan complies with the criteria contained in
Subpart I of this part.
(6) DOE's proposed operating procedures to protect health and to
minimize danger to life or property are adequate.
(b) Common defense and security. That there is reasonable assurance
that the activities proposed in the application will not be inimical to
the common defense and security.
(c) Environmental. That, after weighing the environmental,
economic, technical, and other benefits against environmental costs,
and considering available alternatives, the action called for is
issuance of the construction authorization, with any appropriate
conditions to protect environmental values.
Sec. 63.32 Conditions of construction authorization.
(a) A construction authorization for a geologic repository
operations area at the Yucca Mountain site shall include such
conditions as the Commission finds to be necessary to protect the
health and safety of the public, the common defense and security, or
environmental values.
(b) The Commission will incorporate, in the construction
authorization, provisions requiring DOE to furnish periodic or special
reports regarding:
(1) Progress of construction;
(2) Any data about the site, obtained during construction, that are
not within the predicted limits on which the facility design was based;
(3) Any deficiencies, in design and construction, that, if
uncorrected, could adversely affect safety at any future time; and
(4) Results of research and development programs being conducted to
resolve safety questions.
(c) The construction authorization for a geologic repository
operations area at the Yucca Mountain site will include restrictions on
subsequent changes to the features of the geologic repository and the
procedures authorized. The restrictions that may be imposed under this
paragraph can include measures to prevent adverse effects on the
geologic setting as well as measures related to the design and
construction of the geologic repository operations area. These
restrictions will fall into three categories of descending importance
to public health and safety, as follows:
(1) Those features and procedures that may not be changed without:
(i) 60 days prior notice to the Commission;
(ii) 30 days notice of opportunity for a prior hearing; and
(iii) Prior Commission approval;
(2) Those features and procedures that may not be changed without:
(i) 60 days prior notice to the Commission; and
(ii) Prior Commission approval; and
(3) Those features and procedures that may not be changed without
60 days notice to the Commission. Features and procedures falling in
this paragraph section may not be changed without prior Commission
approval if the Commission, after having received the required notice,
so orders.
(d) A construction authorization shall be subject to the limitation
that a license to receive and possess source, special nuclear, or
byproduct material at the Yucca Mountain site geologic repository
operations area shall not be issued by the Commission until;
(1) DOE has updated its application, as specified in Sec. 63.24;
and
(2) The Commission has made the findings stated in Sec. 63.41.
Sec. 63.33 Amendment of construction authorization.
(a) An application for amendment of a construction authorization
shall be filed with the Commission, fully describing any changes
desired and following as far as applicable the contents prescribed in
Sec. 63.21.
(b) In determining whether an amendment of a construction
authorization will be approved, the Commission will be guided by the
considerations that govern the issuance of the initial construction
authorization, to the extent applicable.
LICENSE ISSUANCE AND AMENDMENT
Sec. 63.41 Standards for issuance of a license.
A license to receive and possess source, special nuclear, or
byproduct material at a geologic repository operations area at the
Yucca Mountain site may be issued by the Commission, on finding that:
(a) Construction of the geologic repository operations area has
been substantially completed in conformity with the application as
amended, the provisions of the Atomic Energy Act, and the rules and
regulations of the Commission. Construction may be deemed to be
substantially complete for the purposes of this paragraph if the
construction of:
(1) Surface and interconnecting structures, systems, and
components; and
(2) Any underground storage space required for initial operation,
are substantially complete.
(b) The activities to be conducted at the geologic repository
operations area will be in conformity with the application as amended,
the provisions of the Atomic Energy Act and the Energy Reorganization
Act, and the rules and regulations of the Commission.
(c) The issuance of the license will not be inimical to the common
defense and security and will not constitute an
[[Page 8671]]
unreasonable risk to the health and safety of the public.
(d) Adequate protective measures can and will be taken in the event
of a radiological emergency at any time before permanent closure and
decontamination or dismantlement of surface facilities.
(e) All applicable requirements of Part 51 of this chapter have
been satisfied.
Sec. 63.42 Conditions of license.
(a) A license issued pursuant to this part shall include such
conditions, including license specifications, as the Commission finds
to be necessary to protect the health and safety of the public, the
common defense and security, and environmental values.
(b) Whether stated therein or not, the following shall be deemed
conditions in every license issued:
(1) The license shall be subject to revocation, suspension,
modification, or amendment for cause, as provided by the Atomic Energy
Act and the Commission's regulations.
(2) DOE shall, at any time while the license is in effect, on
written request of the Commission, submit written statements to enable
the Commission to determine whether or not the license should be
modified, suspended, or revoked.
(3) The license shall be subject to the provisions of the Atomic
Energy Act now or hereafter in effect and to all rules, regulations,
and orders of the Commission. The terms and conditions of the license
shall be subject to amendment, revision, or modification, by reason of
amendments to or by reason of rules, regulations, and orders issued in
accordance with the terms of the Atomic Energy Act.
(c) Each license shall be deemed to contain the provisions set
forth in Section 183 b-d, inclusive, of the Atomic Energy Act, whether
or not these provisions are expressly set forth in the license.
(d) A license issued under this part shall be deemed to contain the
provisions set forth in Section 114(d) of the Nuclear Waste Policy Act,
prohibiting emplacement of a quantity of spent fuel containing in
excess of 70,000 metric tons of heavy metal or a quantity of solidified
high-level radioactive waste resulting from the reprocessing of such a
quantity of spent fuel, until such time as a second repository is in
operation, whether or not these provisions are expressly set forth in
the license.
Sec. 63.43 License specification.
(a) A license issued under this part shall include license
conditions derived from the analyses and evaluations included in the
application, including amendments made before a license is issued,
together with such additional conditions as the Commission finds
appropriate.
(b) License conditions shall include items in the following
categories:
(1) Restrictions as to the physical and chemical form and
radioisotopic content of radioactive waste.
(2) Restrictions as to size, shape, and materials and methods of
construction of radioactive waste packaging.
(3) Restrictions as to the amount of waste permitted per unit
volume of storage space, considering the physical characteristics of
both the waste and the host rock.
(4) Requirements relating to test, calibration, or inspection, to
assure that the foregoing restrictions are observed.
(5) Controls to be applied to restrict access and to avoid
disturbance to the site and to areas outside the site where conditions
may affect compliance with Secs. 63.111 and 63.113.
(6) Administrative controls, which are the provisions relating to
organization and management, procedures, recordkeeping, review and
audit, and reporting necessary to assure that activities at the
facility are conducted in a safe manner and in conformity with the
other license specifications.
Sec. 63.44 Changes, tests, and experiments.
(a)(1) Following authorization to receive and possess source,
special nuclear, or byproduct material at a geologic repository
operations area at the Yucca Mountain site, DOE may:
(i) Make changes in the geologic repository operations area as
described in the application;
(ii) Make changes in the procedures as described in the
application; and
(iii) Conduct tests or experiments not described in the
application, without prior Commission approval, provided the change,
test, or experiment involves neither a change in the license conditions
incorporated in the license nor an unreviewed safety question.
(2) A proposed change, test, or experiment shall be deemed to
involve an unreviewed safety question if:
(i) The likelihood of occurrence or the consequences of an accident
or malfunction of equipment important to safety previously evaluated in
the application is increased;
(ii) The possibility of an accident or malfunction of a different
type than any previously evaluated in the application is created; or
(iii) The margin of safety, as defined in the basis for any license
condition, is reduced.
(b) DOE shall maintain records of changes in the geologic
repository operations area at the Yucca Mountain site and of changes in
procedures made pursuant to this section, to the extent that such
changes constitute changes in the geologic repository operations area
or procedures as described in the application. Records of tests and
experiments carried out pursuant to paragraph (a) of this section shall
also be maintained. These records shall include a written safety
evaluation that provides the basis for the determination that the
change, test, or experiment does not involve an unreviewed safety
question. DOE shall prepare annually, or at such shorter intervals as
may be specified in the license, a report containing a brief
description of such changes, tests, and experiments, including a
summary of the safety evaluation of each. DOE shall furnish the report
to the appropriate NRC Regional Office shown in Appendix D of Part 20
of this chapter, with a copy to the Director, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555. Any report submitted pursuant to this paragraph
shall be made a part of the public record of the licensing proceedings.
Sec. 63.45 Amendment of license.
(a) An application for amendment of a license may be filed with the
Commission fully describing the changes desired and following as far as
applicable the format prescribed for license applications.
(b) In determining whether an amendment of a license will be
approved, the Commission will be guided by the considerations that
govern the issuance of the initial license, to the extent applicable.
Sec. 63.46 Particular activities requiring license amendment.
(a) Unless expressly authorized in the license, an amendment of the
license shall be required with respect to any of the following
activities:
(1) Any action that would make emplaced high-level radioactive
waste irretrievable or which would substantially increase the
difficulty of retrieving such emplaced waste;
(2) Dismantling of structures;
(3) Removal or reduction of controls applied to restrict access to
or avoid disturbance of the site and to areas outside the site where
conditions may affect compliance with Secs. 63.111 and 63.113;
(4) Destruction or disposal of records required to be maintained
under the provisions of this part;
[[Page 8672]]
(5) Any substantial change to the design or operating procedures
from that specified in the license, except as authorized in Sec. 63.44;
(6) Permanent closure; and
(7) Any other activity involving an unreviewed safety question.
(b) An application for such an amendment shall be filed, and shall
be reviewed, in accordance with the provisions of Sec. 63.45.
PERMANENT CLOSURE
Sec. 63.51 License amendment for permanent closure.
(a) DOE shall submit an application to amend the license before
permanent closure of a geologic repository at the Yucca Mountain site.
The submission shall consist of an update of the license application
submitted under Secs. 63.21 and 63.22, including:
(1) An update of the assessment of the performance of the geologic
repository for the period after permanent closure.
(2) A description of the program for post-permanent closure
monitoring of the geologic repository.
(3) A detailed description of the measures to be employed--such as
land use controls, construction of monuments, and preservation of
records--to regulate or prevent activities that could impair the long-
term isolation of emplaced waste within the geologic repository and to
assure that relevant information will be preserved for the use of
future generations. As a minimum, such measures shall include:
(i) Identification of the site and geologic repository operations
area by monuments that have been designed, fabricated, and emplaced to
be as permanent as is practicable;
(ii) Placement of records in the archives and land record systems
of local, State, and Federal government agencies, and archives
elsewhere in the world, that would be likely to be consulted by
potential human intruders--such records to identify the location of the
geologic repository operations area, including the underground
facility, boreholes, shafts and ramps, and the boundaries of the site,
and the nature and hazard of the waste; and
(iii) A program for continued oversight, to prevent any activity at
the site that poses an unreasonable risk of breaching the geologic
repository's engineered barriers; or increasing the exposure of
individual members of the public to radiation beyond allowable limits.
(4) Geologic, geophysical, geochemical, hydrologic, and other site
data that are obtained during the operational period, pertinent to
compliance with Sec. 63.113.
(5) The results of tests, experiments, and any other analyses
relating to backfill of excavated areas, shaft, borehole, or ramp
sealing, waste interaction with the host rock, and any other tests,
experiments, or analyses pertinent to compliance with Sec. 63.113.
(6) Any substantial revision of plans for permanent closure.
(7) Other information bearing on permanent closure that was not
available at the time a license was issued.
(b) If necessary, so as to take into account the environmental
impact of any substantial changes in the permanent closure activities
proposed to be carried out or any significant new information regarding
the environmental impacts of such closure, DOE shall also supplement
its environmental impact statement and submit such statement, as
supplemented, with the application for license amendment.
Sec. 63.52 Termination of license.
(a) Following permanent closure and the decontamination or
dismantlement of surface facilities at the Yucca Mountain site, DOE may
apply for an amendment to terminate the license.
(b) Such application shall be filed and will be reviewed in
accordance with the provisions of Sec. 63.45 and this section.
(c) A license shall be terminated only when the Commission finds
with respect to the geologic repository:
(1) That the final disposition of radioactive wastes has been made
in conformance with DOE's plan, as amended and approved as part of the
license.
(2) That the final state of the geologic repository operations area
conforms to DOE's plans for permanent closure and DOE's plans for the
decontamination or dismantlement of surface facilities, as amended and
approved as part of the license.
(3) That the termination of the license is authorized by law,
including Sections 57, 62, and 81 of the Atomic Energy Act, as amended.
Subpart C--Participation by State Government and Affected Indian
Tribes
Sec. 63.61 Provision of information.
(a) The Director shall provide to the Governor and the Nevada State
legislature, and to the governing body of any affected Indian Tribe,
timely and complete information regarding determinations or plans made
by the Commission with respect to the site characterization, siting,
development, design, licensing, construction, operation, regulation,
permanent closure, or decontamination and dismantlement of surface
facilities, of the geologic repository operations area at the Yucca
Mountain site.
(b) Notwithstanding paragraph (a) of this section, the Director is
not required to distribute any document to any entity if, with respect
to such document, that entity or its counsel is included on a service
list prepared pursuant to Part 2 of this chapter.
(c) Copies of all communications by the Director under this section
shall be placed in the Public Document Room, and copies thereof shall
be furnished to DOE.
Sec. 63.62 Site review.
(a) The Director shall make NRC staff available to consult with
representatives of the State of Nevada and affected Indian Tribes
regarding the status of site characterization at the Yucca Mountain
site.
(b) Requests for consultation shall be made in writing to the
Director.
(c) Consultation under this section may include:
(1) Keeping the parties informed of the Director's views on the
progress of site characterization.
(2) Review of applicable NRC regulations, licensing procedures,
schedules, and opportunities for State and Tribe participation in the
Commission's regulatory activities.
(3) Cooperation in development of proposals for State and Tribe
participation in license reviews.
Sec. 63.63 Participation in license reviews.
(a) State and local governments and affected Indian Tribes may
participate in license reviews as provided in Subpart G of Part 2 of
this chapter. The State of Nevada and any affected Indian Tribe shall
have an unquestionable legal right to participate as a party in such
proceedings.
(b) In addition, a State or an affected Indian Tribe may submit to
the Director a proposal to facilitate its participation in the review
of the license application. The proposal may be submitted at any time
and shall contain a description and schedule of how the State or
affected Indian Tribe wishes to participate in the review, or what
services or activities the State or affected Indian Tribe wishes NRC to
carry out, and how the services or activities proposed to be carried
out by NRC would contribute to such participation. The proposal may
include educational or information services (seminars, public meetings)
or other actions on the part of NRC, such as
[[Page 8673]]
establishing additional public document rooms or employment or exchange
of State personnel under the Intergovernmental Personnel Act.
(c) The Director shall arrange for a meeting between the
representatives of the State or affected Indian Tribe and the NRC
staff, to discuss any proposal submitted under paragraph (b) of this
section, with a view to identifying any modifications that may
contribute to the effective participation by such State or Tribe.
(d) Subject to the availability of funds, the Director shall
approve all or any part of a proposal, as it may be modified through
the meeting described above, if it is determined that:
(1) The proposed activities are suitable in light of the type and
magnitude of impacts that the State or affected Indian Tribe may bear;
(2) The proposed activities:
(i) Will enhance communications between NRC and the State or
affected Indian Tribe;
(ii) Will make a productive and timely contribution to the review;
and
(iii) Are authorized by law.
(e) The Director will advise the State or affected Indian Tribe
whether its proposal has been accepted or denied, and if all or any
part of proposal is denied, the Director shall state the reason for the
denial.
(f) Proposals submitted under this section, and responses thereto,
shall be made available at the Public Document Room.
Sec. 63.64 Notice to State.
If the Governor and legislature of the State of Nevada have jointly
designated, on their behalf, a single person or entity to receive
notice and information from the Commission under this part, the
Commission will provide such notice and information to the jointly
designated person or entity, instead of the Governor and legislature,
separately.
Sec. 63.65 Representation.
Any person who acts under this subpart as a representative for the
State of Nevada (or for the Governor or legislature thereof) or for an
affected Indian Tribe shall include in the request or other submission,
or at the request of the Commission, a statement of the basis of his or
her authority to act in such representative capacity.
Subpart D--Records, Reports, Tests, and Inspections
Sec. 63.71 Records and reports.
(a) DOE shall maintain such records and make such reports in
connection with the licensed activity as may be required by the
conditions of the license or by rules, regulations, and orders of the
Commission, as authorized by the Atomic Energy Act and the Energy
Reorganization Act.
(b) Records of the receipt, handling, and disposition of
radioactive waste at a geologic repository operations area at the Yucca
Mountain site shall contain sufficient information to provide a
complete history of the movement of the waste from the shipper through
all phases of storage and disposal. DOE shall retain these records in a
manner that ensures their usability for future generations in
accordance with Sec. 63.51(a)(2).
Sec. 63.72 Construction records.
(a) DOE shall maintain records of construction of the geologic
repository operations area at the Yucca Mountain site in a manner that
ensures their usability for future generations in accordance with
Sec. 63.51(a)(2).
(b) The records required under paragraph (a) of this section shall
include at least the following:
(1) Surveys of the underground facility excavations, shafts, ramps,
and boreholes referenced to readily identifiable surface features or
monuments;
(2) A description of the materials encountered;
(3) Geologic maps and geologic cross-sections;
(4) Locations and amount of seepage;
(5) Details of equipment, methods, progress, and sequence of work;
(6) Construction problems;
(7) Anomalous conditions encountered;
(8) Instrument locations, readings, and analysis;
(9) Location and description of structural support systems;
(10) Location and description of dewatering systems; and
(11) Details, methods of emplacement, and location of seals used.
Sec. 63.73 Reports of deficiencies.
(a) DOE shall promptly notify the Commission of each deficiency
found in the characteristics of the Yucca Mountain site, and design and
construction of the geologic repository operations area that, were it
to remain uncorrected, could:
(1) Be a substantial safety hazard;
(2) Represent a significant deviation from the design criteria and
design bases stated in the application; or
(3) Represent a deviation from the conditions stated in the terms
of a construction authorization or the license, including license
specifications.
(b) The notification shall be in the form of a written report,
copies of which shall be sent to the Director and to the appropriate
Nuclear Regulatory Commission Regional Office listed in Appendix D of
Part 20 of this chapter.
Sec. 63.74 Tests.
(a) DOE shall perform, or permit the Commission to perform, such
tests as the Commission deems appropriate or necessary for the
administration of the regulations in this part. These may include tests
of:
(1) Radioactive waste,
(2) The geologic repository, including portions of the geologic
setting and the structures, systems, and components constructed or
placed therein,
(3) Radiation detection and monitoring instruments, and
(4) Other equipment and devices used in connection with the
receipt, handling, or storage of radioactive waste.
(b) The tests required under this section shall include a
performance confirmation program carried out in accordance with Subpart
F of this part.
Sec. 63.75 Inspections.
(a) DOE shall allow the Commission to inspect the premises of the
geologic repository operations area at the Yucca Mountain site and
adjacent areas to which DOE has rights of access.
(b) DOE shall make available to the Commission for inspection, on
reasonable notice, records kept by DOE pertaining to activities under
this part.
(c)(1) DOE shall, on requests by the Director, Office of Nuclear
Material Safety and Safeguards, provide rent-free office space for the
exclusive use of the Commission inspection personnel. Heat, air-
conditioning, light, electrical outlets, and janitorial services shall
be furnished by DOE. The office shall be convenient to and have full
access to the facility and shall provide the inspector both visual and
acoustic privacy.
(2) The space provided shall be adequate to accommodate two full-
time inspectors, and other transient NRC personnel and will be
generally commensurate with other office facilities at the Yucca
Mountain site geologic repository operations area. A space of 250
square feet either within the geologic repository operations area's
office complex or in an office trailer or other onsite space at the
geologic repository operations area is suggested as a guide. For
locations at which activities are carried out under licenses issued
under other parts of this chapter, additional space may be requested to
accommodate additional full-time inspectors. The Office space that is
provided shall be subject to the approval of the Director, Office of
[[Page 8674]]
Nuclear Material Safety and Safeguards. All furniture, supplies, and
communication equipment will be furnished by the Commission.
(3) DOE shall afford any NRC resident inspector assigned to the
Yucca Mountain site or other NRC inspectors identified by the Regional
Administrator as likely to inspect the Yucca Mountain facility,
immediate unfettered access, equivalent to access provided regular
employees, after proper identification and compliance with applicable
access control measures for security, radiological protection, and
personal safety.
Sec. 63.78 Material control and accounting records and reports.
DOE shall implement a program of material control and accounting
(and accidental criticality reporting) that is the same as that
specified in Secs. 72.72, 72.74, 72.76, and 72.78 of this chapter.
Subpart E--Technical Criteria
Sec. 63.101 Purpose and nature of findings.
(a)(1) Subpart B of this part prescribes the standards for issuance
of a license to receive and possess source, special nuclear, or
byproduct material at a geologic repository operations area at the
Yucca Mountain site. In particular, Sec. 63.41(c) requires a finding
that the issuance of a license will not constitute an unreasonable risk
to the health and safety of the public. The purpose of this subpart is
to set out the performance objectives and other criteria that, if
satisfied, will support such a finding of no unreasonable risk.
(2) Although the performance objective for the geologic repository
after permanent closure specified at Sec. 63.113 is generally stated in
unqualified terms, it is not expected that complete assurance that the
requirement will be met can be presented. A reasonable assurance, on
the basis of the record before the Commission, that the performance
objective will be met is the general standard that is required. Proof
that the geologic repository will be in conformance with the objective
for postclosure performance is not to be had in the ordinary sense of
the word because of the uncertainties inherent in the understanding of
the evolution of the geologic setting, biosphere, and engineered
barrier system. For such long-term performance, what is required is
reasonable assurance, making allowance for the time period, hazards,
and uncertainties involved, that the outcome will be in conformance
with the objective for postclosure performance of the geologic
repository. Demonstrating compliance will involve the use of complex
predictive models that are supported by limited data from field and
laboratory tests, site-specific monitoring, and natural analog studies
that may be supplemented with prevalent expert judgment. Further, in
reaching a determination of reasonable assurance, the Commission may
supplement numerical analyses with qualitative judgments including, for
example, consideration of the degree of diversity among the multiple
barriers as a measure of the resiliency of the geologic repository.
(b) Subpart B of this part also lists findings that must be made in
support of an authorization to construct a geologic repository
operations area at the Yucca Mountain site. In particular,
Sec. 63.31(a) requires a finding that there is reasonable assurance
that the types and amounts of radioactive materials described in the
application can be received, possessed, and disposed of in a geologic
repository operations area of the design proposed without unreasonable
risk to the health and safety of the public. As stated in that
paragraph, in arriving at this determination, the Commission will
consider whether DOE has demonstrated that the geologic repository
complies with the criteria contained in this subpart. Once again,
although the criteria may be written in unqualified terms, the
demonstration of compliance must take uncertainties and gaps in
knowledge into account so that the Commission can make the specified
finding with respect to reasonable assurance as specified in paragraph
(a) of this section.
Sec. 63.102 Concepts.
This section provides a functional overview of this Subpart E. In
the event of any inconsistency with definitions found in Sec. 63.2,
those definitions shall prevail.
(a) The HLW facility at the Yucca Mountain site. NRC exercises
licensing and related regulatory authority over those facilities
described in Section 202 (3) and (4) of the Energy Reorganization Act
of 1974, including the site at Yucca Mountain, as designated by the
Energy Policy Act of 1992.
(b) The geologic repository operations area. (1) This part deals
with the exercise of authority with respect to a particular class of
HLW facility--namely, a geologic repository operations area at Yucca
Mountain.
(2) A geologic repository operations area consists of those surface
and subsurface areas of the site that are part of a geologic repository
where radioactive waste handling activities are conducted. The
underground structure, backfill materials, if any, and openings that
penetrate the underground structure (e.g., ramps, shafts and boreholes,
including their seals), are designated the underground facility.
(3) The exercise of Commission authority requires that the geologic
repository operations area be used for storage (which includes
disposal) of high-level radioactive wastes (HLW).
(4) HLW includes irradiated reactor fuel as well as reprocessing
wastes. However, if DOE proposes to use the geologic repository
operations area for storage of radioactive waste other than HLW, the
storage of this radioactive waste is subject to the requirements of
this part.
(c) Stages in the licensing process. There are several stages in
the licensing process. The site characterization stage, when the
performance confirmation program is started, begins before submission
of a license application, and may result in consequences requiring
evaluation in the license review. The construction stage would follow,
after issuance of a construction authorization. A period of operations
follows the Commission's issuance of a license. The period of
operations includes the time during which emplacement of wastes occurs;
any subsequent period before permanent closure during which the
emplaced wastes are retrievable; and permanent closure, which includes
sealing openings to the repository. Permanent closure represents the
end of the performance confirmation program; final backfilling of the
underground facility, if appropriate; and the sealing of shafts, ramps,
and boreholes.
(d) Areas related to isolation. Although the activities subject to
regulation under this part are those to be carried out at the geologic
repository operations area, the licensing process also considers
characteristics of adjacent areas that are defined in other ways. There
must be an area surrounding the geologic repository operations area,
that could include either a portion or all of the site, within which
DOE must exercise specified controls to prevent adverse human actions
after permanent closure. There is an area, designated the geologic
setting, which includes the geologic, hydrologic, and geochemical
systems of the region in which the site and geologic repository
operations area are located. The geologic repository operations area,
plus the portion of the geologic setting that provides isolation of the
radioactive waste, make up the geologic repository.
(e) Performance objectives through permanent closure. Before
permanent closure, the geologic repository operations area is required
to limit
[[Page 8675]]
radiation levels and exposures, in both restricted and unrestricted
areas, and releases of radioactive materials to unrestricted areas, as
specified at Sec. 63.111(a).
(f) Integrated safety analysis. Section 63.111 includes performance
objectives for the geologic repository operations area for the period
before permanent closure and decontamination or dismantlement of
surface facilities. The integrated safety analysis is a systematic
examination of the geologic repository operations area's hazards and
their potential for initiating event sequences; the potential event
sequences and their consequences; and the site, structures, systems,
components, equipment, and activities of personnel, to ensure that all
relevant hazards that could result in unacceptable consequences have
been adequately evaluated and appropriate protective measures have been
identified. As used here, integrated means joint consideration of
safety measures that otherwise might conflict, including, but not
limited to, integration of fire protection, radiation safety,
criticality safety, and chemical safety measures. The results of this
analysis will support a determination regarding compliance of the
geologic repository operations area with the requirements specified at
Sec. 63.111.
(g) Performance objective after permanent closure. After permanent
closure, the geologic repository is required to limit the expected
annual dose to the average member of the critical group, as specified
at Sec. 63.113(b).
(h) Multiple barriers. 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 a
portion of the geologic setting will be capable of contributing to the
isolation of radioactive waste, and thus be a barrier important to
waste isolation. Although there is an extensive geologic record ranging
from thousands to millions of years, this record is subject to
interpretation and includes many uncertainties. In addition, there are
uncertainties in the isolation capability and performance of engineered
barriers. Although the composition and configuration of engineered
structures (barriers) can be defined with a degree of precision not
possible for natural barriers, it is recognized that except for a few
archaeologic analogues, there is a limited experience base for the
performance of complex, engineered structures over periods longer than
a few hundred years considering the uncertainty in characterizing and
modeling individual barriers. These uncertainties are addressed by
requiring the use of a multiple barrier approach; specifically, an
engineered barrier system is required in addition to the natural
barriers provided by the geologic setting. It is intended that natural
barriers and the engineered barrier system work in combination to
enhance the resiliency of the geologic repository and increase
confidence that the postclosure performance objective at Sec. 63.113(b)
will be achieved.
(i) Reference biosphere and critical group. The performance
assessment will estimate the amount of radioactive material released to
water or air at various locations and times in the future. To estimate
the potential for future human exposures resulting from release of
radioactive material from a geologic repository at Yucca Mountain, it
is necessary to make certain assumptions about the location and
characteristics of a critical group. The environment inhabited by the
critical group, along with associated human exposure pathways and dose
assessment parameters, make up the reference biosphere. The critical
group is selected to represent those persons in the vicinity of Yucca
Mountain who are reasonably expected to receive the greatest exposure
to radioactive material released from a geologic repository at Yucca
Mountain. Characteristics of the reference biosphere and the critical
group are to be based on current human behavior and biospheric
conditions in the region.
(j) Performance assessment. Demonstrating compliance with the
postclosure performance objective specified at Sec. 63.113(b) requires
a performance assessment to quantitatively estimate the expected annual
dose, over the compliance period, to the average member of the critical
group. The performance assessment is a systematic analysis that
identifies the features, events, and processes (i.e., specific
conditions or attributes of the geologic setting, degradation,
deterioration, or alteration processes of engineered barriers, and
interactions between the natural and engineered barriers) that might
affect performance of the geologic repository; examines their effects
on performance; and estimates the expected annual dose. The features,
events, and processes considered in the performance assessment should
represent a wide range of both beneficial and potentially adverse
effects on performance (e.g., beneficial effects of radionuclide
sorption; potentially adverse effects of fracture flow or a criticality
event). Those features, events, and processes expected to materially
affect compliance with Sec. 63.113(b) or be potentially adverse to
performance are included, while events of very low probability of
occurrence (less than one chance in 10,000 over 10,000 years) can be
excluded from the analysis. The expected annual dose to the average
member of the critical group is estimated using the selected features,
events, and processes, and incorporating the probability that the
estimated dose will occur.
(k) Institutional controls. Active and passive institutional
controls will be maintained over the Yucca Mountain site, and are
expected to reduce significantly, but not eliminate, the potential for
human activity that could inadvertently cause or accelerate the release
of radioactive material. Because it is not possible to make
scientifically sound forecasts of the long-term reliability of such
controls, however, it is not appropriate to integrate consideration of
human intrusion into a fully risk-based performance assessment for
purposes of evaluating the ability of the geologic repository to
achieve the performance objective at Sec. 63.113(b). Hence, human
intrusion is addressed in a stylized manner as described in paragraph l
of this section.
(l) Human intrusion. In contrast to events unrelated to human
activity, the probability and characteristics of human intrusion
occurring many hundreds or thousands of years into the future cannot be
estimated by examining either the historic or geologic record. Rather
than speculating on the nature and probability of future intrusion, it
is more useful to assess how resilient the geologic repository would be
against a postulated intrusion as specified at Sec. 63.113(d). Although
the consequences of an assumed intrusion event is a separate analysis,
the analysis is identical to the performance assessment required by
Sec. 63.113(c); except that it assumes the occurrence of a postulated
human intrusion event.
(m) Performance confirmation. A performance confirmation program
will be conducted to verify the assumptions, data, and analyses that
support the performance assessment, and any findings, based thereon,
that permitted construction of the repository. Key geologic,
hydrologic, geomechanical, and other physical parameters will be
monitored throughout site characterization, construction, emplacement,
and operation to detect any significant changes in the conditions
assumed in the performance assessment that may affect compliance with
the performance objective at Sec. 63.113(b).
[[Page 8676]]
PERFORMANCE OBJECTIVES
Sec. 63.111 Performance objectives for the geologic repository
operations area through permanent closure.
(a) Protection against radiation exposures and releases of
radioactive material.
(1) The geologic repository operations area shall meet the
requirements of Part 20 of this chapter.
(2) During normal operations, and for Category 1 design basis
events, the annual dose to any real member of the public, located
beyond the boundary of the site shall not exceed a TEDE of 0.25 mSv (25
mrem).
(b) Numerical Guides for Design Objectives. (1) The geologic
repository operations area shall be designed so that taking into
consideration Category 1 design basis events and until permanent
closure has been completed, radiation exposures and radiation levels in
both restricted and unrestricted areas, and releases of radioactive
materials to unrestricted areas, will be maintained within the limits
specified in paragraph (a) of this section.
(2) The geologic repository operations area shall be designed so
that taking into consideration Category 2 design basis events and until
permanent closure has been completed, no individual located on, or
beyond, any point on the boundary of the site, will receive the more
limiting of a TEDE of 0.05 Sv (5 rem), or the sum of the deep dose
equivalent and the committed dose equivalent to any individual organ or
tissue (other than the lens of the eye) of 0.5 Sv (50 rem). The lens
dose equivalent shall not exceed 0.15 Sv (15 rem), and the shallow dose
equivalent to skin shall not exceed 0.5 Sv (50 rem).
(c) Integrated safety analysis. An integrated safety analysis of
the geologic repository operations area that meets the requirements
specified at Sec. 63.112 shall be performed. This analysis shall
include a demonstration that:
(1) The requirements of Sec. 63.111(a) will be met; and
(2) The design meets the requirements of Sec. 63.111(b).
(d) Performance confirmation. The geologic repository operations
area shall be designed so as to permit implementation of a performance
confirmation program that meets the requirements of Subpart F of this
part.
(e) Retrievability of waste. (1) The geologic repository operations
area shall be designed to preserve the option of waste retrieval
throughout the period during which wastes are being emplaced and
thereafter, until the completion of a performance confirmation program
and Commission review of the information obtained from such a program.
To satisfy this objective, the geologic repository operations area
shall be designed so that any or all of the emplaced waste could be
retrieved on a reasonable schedule starting at any time up to 50 years
after waste emplacement operations are initiated, unless a different
time period is approved or specified by the Commission. This different
time period may be established on a case-by-case basis consistent with
the emplacement schedule and the planned performance confirmation
program.
(2) This requirement shall not preclude decisions by the Commission
to allow backfilling part, or all of, or permanent closure of, the
geologic repository operations area, before the end of the period of
design for retrievability.
(3) For purposes of this paragraph, a reasonable schedule for
retrieval is one that would permit retrieval in about the same time as
that required to construct the geologic repository operations area and
emplace waste.
INTEGRATED SAFETY ANALYSIS
Sec. 63.112 Requirements for integrated safety analysis of the
geologic repository operations area.
The integrated safety analysis of the geologic repository
operations area shall include:
(a) A general description of the structures, systems, components,
equipment, and process activities at the geologic repository operations
area.
(b) An identification and systematic analysis of naturally
occurring and human-induced hazards at the geologic repository
operations area, including a comprehensive identification of potential
accident/event sequences that would result in unacceptable consequences
(i.e., design basis events).
(c) Data pertaining to the Yucca Mountain site, and the surrounding
region to the extent necessary, used to identify naturally occurring
and human-induced hazards at the geologic repository operations area.
(d) The technical basis for either inclusion or exclusion of
specific, naturally occurring and human-induced hazards in the safety
analysis.
(e) An analysis of the performance of the major design structures,
systems, and components, both surface and subsurface, to identify those
that are important to safety, including identification and description
of controls that are relied on to limit or prevent potential accidents
or mitigate their consequences, and including identification of
measures taken to ensure the availability of identified safety systems.
The analysis required in this paragraph shall include, but not
necessarily be limited to, consideration of:
(1) Means to limit concentration of radioactive material in air;
(2) Means to limit the time required to perform work in the
vicinity of radioactive materials;
(3) Suitable shielding;
(4) Means to monitor and control the dispersal of radioactive
contamination;
(5) Means to control access to high radiation areas or airborne
radioactivity area;
(6) Means to control criticality;
(7) Radiation alarm system to warn of significant increases of
radiation levels, concentrations of radioactive material in air, and
increased radioactivity in effluents;
(8) Ability of structures, systems, and components to perform their
intended safety functions, assuming the occurrence of design basis
events;
(9) Explosion and fire detection systems and appropriate
suppression systems;
(10) Means to control radioactive waste and radioactive effluents,
and permit prompt termination of operations and evacuation of personnel
during an emergency;
(11) Means to provide reliable and timely emergency power to
instruments, utility service systems, and operating systems important
to safety if there is a loss of primary electric power;
(12) Means to provide redundant systems necessary to maintain, with
adequate capacity, the ability of utility services important to safety;
and
(13) Means to inspect, test, and maintain structures, systems, and
components important to safety, as necessary, to ensure their continued
functioning and readiness.
(f) A description and discussion of the design, both surface and
subsurface, of the geologic repository operations area, including:
(1) The relationship between principal design criteria and the
requirements specified at Sec. 63.111(a) and (b); and
(2) The design bases and their relation to the principal design
criteria.
Sec. 63.113 Performance objective for the geologic repository after
permanent closure.
(a) The geologic repository shall include multiple barriers,
consisting of both natural barriers and an engineered barrier system.
(b) The engineered barrier system shall be designed so that,
working in combination with natural barriers, the expected annual dose
to the average
[[Page 8677]]
member of the critical group shall not exceed 0.25 mSv (25 mrem) TEDE
at any time during the first 10,000 years after permanent closure, as a
result of radioactive materials released from the geologic repository.
(c) The ability of the geologic repository to limit radiological
exposures to those specified in paragraph (b) of this section shall be
demonstrated through a performance assessment that meets the
requirements specified at Sec. 63.114, uses the reference biosphere and
critical group specified at Sec. 63.115, and excludes the effects of
human intrusion.
(d) The ability of the geologic repository to limit radiological
exposures to those specified in paragraph (b) of this section, in the
event of limited human intrusion into the engineered barrier system,
shall be demonstrated through a separate performance assessment that
meets the requirements specified at Sec. 63.114 and uses the reference
biosphere and critical group specified at Sec. 63.115. For the
assessment required by this paragraph, it shall be assumed that the
human intrusion occurs 100 years after permanent closure and takes the
form of a drilling event that results in a single, nearly vertical
borehole that penetrates a waste package, extends to the saturated
zone, and is not adequately sealed.
PERFORMANCE ASSESSMENT
Sec. 63.114 Requirements for performance assessment.
Any performance assessment used to demonstrate compliance with
Sec. 63.113(b) shall:
(a) Include data related to the geology, hydrology, and
geochemistry (including disruptive processes and events) of the Yucca
Mountain site, and the surrounding region to the extent necessary, and
information on the design of the engineered barrier system, used to
define parameters and conceptual models used in the assessment.
(b) Account for uncertainties and variabilities in parameter values
and provide the technical basis for parameter ranges, probability
distributions, or bounding values used in the performance assessment.
(c) Consider alternative conceptual models of features and
processes that are consistent with available data and current
scientific understanding, and evaluate the effects that alternative
conceptual models have on the performance of the geologic repository.
(d) Consider only events that have at least one chance in 10,000 of
occurring over 10,000 years.
(e) Provide the technical basis for either inclusion or exclusion
of specific features, events, and processes of the geologic setting in
the performance assessment. Specific features, events, and processes of
the geologic setting must be evaluated in detail if the magnitude and
time of the resulting expected annual dose would be significantly
changed by their omission.
(f) Provide the technical basis for either inclusion or exclusion
of degradation, deterioration, or alteration processes of engineered
barriers in the performance assessment, including those processes that
would adversely affect the performance of natural barriers.
Degradation, deterioration, or alteration processes of engineered
barriers must be evaluated in detail if the magnitude and time of the
resulting expected annual dose would be significantly changed by their
omission.
(g) Provide the technical basis for 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).
(h) Identify those design features of the engineered barrier
system, and natural features of the geologic setting, that are
considered barriers important to waste isolation.
(i) Describe the capability of barriers, identified as important to
waste isolation, to isolate waste, taking into account uncertainties in
characterizing and modeling the barriers.
(j) Provide the technical basis for the description of the
capability of barriers, identified as important to waste isolation, to
isolate waste.
CHARACTERISTICS OF THE REFERENCE BIOSPHERE AND CRITICAL GROUP
Sec. 63.115 Required characteristics of the reference biosphere and
critical group.
(a) Reference biosphere. (1) Features, events, and processes that
describe the reference biosphere shall be consistent with present
knowledge of the conditions in the region surrounding the Yucca
Mountain site.
(2) Biosphere pathways shall be consistent with arid or semi-arid
conditions.
(3) Climate evolution shall be consistent with the geologic record
of natural climate change in the region surrounding the Yucca Mountain
site.
(4) Evolution of the geologic setting shall be consistent with
present knowledge of natural processes.
(b) Critical group. (1) The critical group shall reside within a
farming community located approximately 20 km south from the
underground facility (in the general location of U.S. Route 95 and
Nevada Route 373, near Lathrop Wells, Nevada).
(2) The behaviors and characteristics of the farming community
shall be consistent with current conditions of the region surrounding
the Yucca Mountain site. Changes over time in the behaviors and
characteristics of the critical group including, but not necessarily
limited to, land use, lifestyle, diet, human physiology, or metabolics;
shall not be considered.
(3) The critical group resides within a farming community
consisting of approximately 100 individuals, and exhibits behaviors or
characteristics that will result in the highest expected annual doses.
(4) The behaviors and characteristics of the average member of the
critical group shall be based on the mean value of the critical group's
variability range. The mean value shall not be unduly biased based on
the extreme habits of a few individuals.
(5) The average member of the critical group shall be an adult.
Metabolic and physiological considerations shall be consistent with
present knowledge of adults.
LAND OWNERSHIP AND CONTROL
Sec. 63.121 Requirements for ownership and control of interests in
land.
(a) Ownership of land. (1) Both the geologic repository operations
area and the site shall be located in and on lands that are either
acquired lands under the jurisdiction and control of DOE, or lands
permanently withdrawn and reserved for its use.
(2) These lands shall be held free and clear of all encumbrances,
if significant, such as:
(i) Rights arising under the general mining laws;
(ii) Easements for right-of-way; and
(iii) All other rights arising under lease, rights of entry, deed,
patent, mortgage, appropriation, prescription, or otherwise.
(b) Additional controls. Appropriate controls shall be established
outside of the site. DOE shall exercise any jurisdiction and control
over surface and subsurface estates necessary to prevent adverse human
actions that could significantly reduce the geologic repository's
ability to achieve isolation. The rights of DOE may take the form of
appropriate possessory interests, servitudes, or withdrawals from
location or patent under the general mining laws.
(c) Water rights. (1) DOE shall also have obtained such water
rights as may
[[Page 8678]]
be needed to accomplish the purpose of the geologic repository
operations area.
(2) Water rights are included in the additional controls to be
established under paragraph (b) of this section.
Subpart F--Performance Confirmation Program
Sec. 63.131 General requirements.
(a) The performance confirmation program shall provide data that
indicate, where practicable, whether:
(1) Actual subsurface conditions encountered and changes in those
conditions during construction and waste emplacement operations are
within the limits assumed in the licensing review; and
(2) Geologic and engineered systems and components required for
repository operation, and that are designed or assumed to operate as
barriers after permanent closure, are functioning as intended and
anticipated.
(b) The program shall have been started during site
characterization and it will continue until permanent closure.
(c) The program shall include in-situ monitoring, laboratory and
field testing, and in-situ experiments, as may be appropriate to
provide the data required by paragraph (a) of this section.
(d) The program shall be implemented so that:
(1) It does not adversely affect the ability of the geologic and
engineered elements of the geologic repository to meet the performance
objectives.
(2) It provides baseline information and analysis of that
information on those parameters and natural processes pertaining to the
geologic setting that may be changed by site characterization,
construction, and operational activities.
(3) It monitors and analyzes changes from the baseline condition of
parameters that could affect the performance of a geologic repository.
Sec. 63.132 Confirmation of geotechnical and design parameters.
(a) During repository construction and operation, a continuing
program of surveillance, measurement, testing, and geologic mapping
shall be conducted to ensure that geotechnical and design parameters
are confirmed and to ensure that appropriate action is taken to inform
the Commission of changes needed in design to accommodate actual field
conditions encountered.
(b) Subsurface conditions shall be monitored and evaluated against
design assumptions.
(c) As a minimum, measurements shall be made of rock deformations
and displacement; changes in rock stress and strain; rate and location
of water inflow into subsurface areas; changes in groundwater
conditions; rock pore water pressures, including those along fractures
and joints; and the thermal and thermomechanical response of the rock
mass as a result of development and operations of the geologic
repository.
(d) These measurements and observations shall be compared with the
original design bases and assumptions. If significant differences exist
between the measurements and observations and the original design bases
and assumptions, the need for modifications to the design or in
construction methods shall be determined and these differences, their
significance to repository performance, and the recommended changes
reported to the Commission.
(e) In-situ monitoring of the thermomechanical response of the
underground facility shall be conducted until permanent closure, to
ensure that the performance of the geologic and engineering features is
within design limits.
Sec. 63.133 Design testing.
(a) During the early or developmental stages of construction, a
program for in-situ testing of such features as borehole and shaft
seals, backfill, and the thermal interaction effects of the waste
packages, backfill, rock, and groundwater shall be conducted.
(b) The testing shall be initiated as early as practicable.
(c) A backfill test section shall be constructed to test the
effectiveness of backfill placement and compaction procedures against
design requirements before permanent backfill placement is begun.
(d) Test sections shall be established to test the effectiveness of
borehole, shaft, and ramp seals before full-scale operation proceeds to
seal boreholes, shafts, and ramps.
Sec. 63.134 Monitoring and testing waste packages.
(a) A program shall be established at the geologic repository
operations area for monitoring the condition of the waste packages.
Waste packages chosen for the program shall be representative of those
to be emplaced in the underground facility.
(b) Consistent with safe operation at the geologic repository
operations area, the environment of the waste packages selected for the
waste package monitoring program shall be representative of the
environment in which the wastes are to be emplaced.
(c) The waste package monitoring program shall include laboratory
experiments that focus on the internal condition of the waste packages.
To the extent practical, the environment experienced by the emplaced
waste packages within the underground facility during the waste package
monitoring program shall be duplicated in the laboratory experiments.
(d) The waste package monitoring program shall continue as long as
practical up to the time of permanent closure.
Subpart G--Quality Assurance
Sec. 63.141 Scope.
As used in this part, quality assurance comprises all those planned
and systematic actions necessary to provide adequate confidence that
the geologic repository and its subsystems or components will perform
satisfactorily in service. Quality assurance includes quality control,
which comprises those quality assurance actions related to the physical
characteristics of a material, structure, component, or system that
provide a means to control the quality of the material, structure,
component, or system to predetermined requirements.
Sec. 63.142 Applicability.
The quality assurance program applies to all systems, structures,
and components important to safety, to design and characterization of
barriers important to waste isolation, and to activities related
thereto. These activities include: site characterization, facility and
equipment construction, facility operation, performance confirmation,
permanent closure, and decontamination and dismantling of surface
facilities.
Sec. 63.143 Implementation.
DOE shall implement a quality assurance program based on the
criteria of Appendix B of 10 CFR Part 50, as applicable, and
appropriately supplemented by additional criteria, as required by
Sec. 63.142.
Subpart H--Training and Certification of Personnel
Sec. 63.151 General requirements.
Operations of systems and components that have been identified as
important to safety in the Safety Analysis Report and in the license
shall be performed only by trained and certified personnel or by
personnel under the direct visual supervision of an individual with
training and certification in such operation. Supervisory personnel who
direct operations that are important to safety must also be certified
in such operations.
[[Page 8679]]
Sec. 63.152 Training and certification program.
DOE shall establish a program for training, proficiency testing,
certification, and requalification of operating and supervisory
personnel.
Sec. 63.153 Physical requirements.
The physical condition and the general health of personnel
certified for operations that are important to safety shall not be such
as might cause operational errors that could endanger the public health
and safety. Any condition that might cause impaired judgment or motor
coordination must be considered in the selection of personnel for
activities that are important to safety. These conditions need not
categorically disqualify a person, so long as appropriate provisions
are made to accommodate such conditions.
Subpart I--Emergency Planning Criteria
Sec. 63.161 Emergency plan for the geologic repository operations area
through permanent closure.
DOE shall develop and be prepared to implement a plan to cope with
radiological accidents that may occur at the geologic repository
operations area, at any time before permanent closure and
decontamination or dismantlement of surface facilities. The emergency
plan shall be based on the criteria of Sec. 72.32(b) of this chapter.
Subpart J--Violations
Sec. 63.171 Violations.
(a) The Commission may obtain an injunction or other court order to
prevent a violation of the provisions of--
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974, as amended;
or
(3) A regulation or order issued pursuant to those Acts.
(b) The Commission may obtain a court order for the payment of a
civil penalty imposed under section 234 of the Atomic Energy Act:
(1) For violations of--
(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of
the Atomic Energy Act of 1954, as amended;
(ii) Section 206 of the Energy Reorganization Act;
(iii) Any rule, regulation, or order issued pursuant to the
sections specified in paragraph (b)(1)(i) of this section;
(iv) Any term, condition, or limitation of any license issued under
the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under
section 186 of the Atomic Energy Act of 1954, as amended.
Sec. 63.172 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1954, as amended,
provides for criminal sanctions for willful violation of, attempted
violation of, or conspiracy to violate, any regulation issued under
Sections 161b, 161i, or 161o of the Act. For purposes of Section 223,
all the regulations in this Part 63 are issued under one or more of
Sections 161b, 161i, or 161o, except for the sections listed in
paragraph (b) of this section.
(b) The regulations in this Part 63 that are not issued under
Sections 161b, 161i, or 161o for the purposes of Section 223 are as
follows: Sections 63.1, 63.2, 63.5, 63.6, 63.7, 63.8, 63.15, 63.16,
63.21, 63.22, 63.23, 63.24, 63.31, 63.32, 63.33, 63.41, 63.42, 63.43,
63.45, 63.46, 63.51, 63.52, 63.61, 63.62, 63.63, 63.64, 63.65, 63.101,
63.102, 63.111, 63.112, 63.113, 63.114, 63.115, 63.121, 63.131, 63.132,
63.133, 63.134, 63.141, 63.142, 63.153, 63.171, and 63.172.
Dated at Rockville, Maryland, this 12th day of February, 1999.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 99-4022 Filed 2-19-99; 8:45 am]
BILLING CODE 7590-01-P
