Disposal of High-Level Radioactive Wastes in a Proposed Geologic Repository at Yucca Mountain, Nevada
Federal RegisterFeb 22, 1999
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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
[email protected], or Clark Prichard, Office of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone (301) 415-6203; e-mail [email protected].
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.
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\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.
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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
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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
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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
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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 BJS[email protected]; 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
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