[Federal Register Volume 64, Number 34 (Monday, February 22, 1999)]
[Proposed Rules]
[Pages 8640-8679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4022]



[[Page 8639]]

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Part II





Nuclear Regulatory Commission





_______________________________________________________________________



10 CFR Part 19 et al.



Disposal of High-Level Radioactive Wastes in a Proposed Geological 
Repository at Yucca Mountain, Nevada; Proposed Rule

  Federal Register / Vol. 64, No. 34 / Monday, February 22, 1999 / 
Proposed Rules  

[[Page 8640]]



NUCLEAR REGULATORY COMMISSION

10 CFR Parts 2, 19, 20, 21, 30, 40, 51, 60, 61, and 63

RIN 3150-AG04


Disposal of High-Level Radioactive Wastes in a Proposed Geologic 
Repository at Yucca Mountain, Nevada

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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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.
---------------------------------------------------------------------------

    To identify an appropriate objective for repository performance 
after permanent closure, the Commission seeks to establish a constraint 
that, if met, would provide reasonable assurance that doses to members 
of the general public will remain below acceptable levels. 
International guidance on dose limits suggests establishing constraint 
limits for specific sources (such as a HLW repository) to ensure that 
exposure to members of the public from all sources, excluding 
background radiation, is less than the public dose limit. In the case 
of operational releases, compliance with the requirements of 10 CFR 
Part 20 can be expected, based on Commission experience with its other 
licensed facilities, to limit effluents far below the public annual 
dose limit of 1 mSv (100 mrem). For postclosure exposures, the 
performance of the repository must depend on passive systems limiting 
the exposure. Therefore, the performance objective for postclosure must 
be established such that the public would not receive doses, from all 
possible sources, excluding background radiation, in excess of 1 mSv 
(100 mrem) per year.
    The Commission proposes a limit of 0.25 mSv (25 mrem) to the total 
effective dose equivalent, received in a single year and weighted by 
the probability of occurrence, by the average member of the critical 
group, as the overall system performance objective for the repository, 
following permanent closure. This criterion would limit the dose 
received from all possible pathways to the critical group at Yucca 
Mountain, including direct exposure, drinking of contaminated water, 
eating food that was irrigated with contaminated groundwater or grown 
in contaminated soil, exposure to airborne releases, etc. The 
Commission believes that application of a single, all-pathway standard 
is protective of public health and safety, and obviates the need for 
separate, single pathway limits. The Commission established the 0.25 
mSv (25 mrem) annual dose limit as the overall safety objective for 
both decommissioning of nuclear facilities (10 CFR 20.1402) and for 
low-level radioactive waste disposal facilities (10 CFR 61.41). It is 
within the range of international constraints that allocate doses from 
high level waste disposal to between 0.1 and 0.3 mSv (10 and 30 mrem) 
per year, and is comparable to the risk range recommended by NAS as a 
reasonable starting point for EPA's rulemaking (a risk range of between 
10 -5 and 10 -6 per year, approximately 
equivalent to annual doses between 0.02 and 0.2 mSv (2 and 20 mrem)). 
The Commission believes that 0.25 mSv (25 mrem) per year is 
sufficiently below the public dose limit that no members of the public 
near Yucca Mountain would be expected to receive doses from all 
sources, excluding background radiation, in excess of 1 mSv (100 mrem) 
per year. Estimates of potential exposures at Yucca Mountain are 
expected to be probabilistic because these estimates will consider 
variability and uncertainty in the features and processes, and a range 
of events each with specific probability of occurrence over the time 
period of interest at the site. The Commission proposes that an 
expected annual dose, based on the probabilistic results, is 
representative of individual risk and would be compared to the 
individual protection standard for determining compliance. Calculation 
of the expected annual dose incorporates the probability that the 
estimated dose will occur (i.e., annual dose estimates consider the 
probability of the occurrence of the events and the

[[Page 8645]]

uncertainty and variability of the parameter values used to describe 
the behavior of the geologic repository).

VI. Reference Biosphere and Critical Group for Yucca Mountain

    In addition to establishing an individual protection limit as an 
overall system performance objective, as discussed above, it is 
necessary to specify the individual or individuals for whom the 
performance calculation is to be made, as well as the environment in 
which the individual(s) reside, and the relevant pathways for potential 
exposure. In this regard, the NAS observed that the appropriate 
objective should be to ``protect the vast majority of members of the 
public while also ensuring that the decision on the acceptability of a 
repository is not prejudiced by the risks imposed on a very small 
number of individuals with unusual habits or sensitivities.'' NAS 
recommended that the characteristics of the critical group and 
reference biosphere be defined in regulation. Citing guidance of ICRP, 
NAS recommended the critical group be representative of those 
individuals in the population expected to receive the highest dose 
equivalent, should be relatively homogeneous with respect to the 
location, habits, and metabolic characteristics that affect the doses 
received; and the habits and characteristics of the group should be 
based on present knowledge using cautious, but reasonable, assumptions. 
Although the ICRP guidance was developed for present day releases to 
existing populations that could be surveyed, monitored, and screened to 
find the few actual individuals that would be members of the critical 
group, the Commission has used the ICRP principles in developing 
specifications for the critical group and reference biosphere.
    Demonstration of compliance with an individual dose limit over 
thousands of years requires the use of certain assumptions about the 
characteristics of the individual or group to be protected, as well as 
the characteristics of the biosphere in which the critical group 
resides, for purposes of analyzing the performance of the waste 
disposal facility. Difficulties in forecasting the characteristics of 
future society, especially those influencing exposure, lead to large 
uncertainties in the estimates of who will be exposed, by how much, and 
when.
    The Commission is proposing to limit speculation by specifying the 
assumptions to be used by DOE in developing the assumed critical group 
and reference biosphere appropriate for Yucca Mountain. The Commission 
is proposing criteria at Sec. 63.115 for identifying a critical group 
and reference biosphere that the Commission believes provide a 
reasonable basis for demonstrating compliance and that preclude 
unbounded speculation. The Commission's intent here is to define 
characteristics that would otherwise be subject to unlimited 
speculation, and to identify how available information is to be used by 
DOE to identify the average member of the critical group. The 
identification of those individuals expected to receive the highest 
dose will be most sensitive to attributes such as location, percentage 
of diet from locally-produced food, lifestyle, and land use. Based on 
present day knowledge of the habits and characteristics of the local 
population in the vicinity of Yucca Mountain, Sec. 63.115 specifies a 
farming critical group located approximately 20 km south from the 
underground facility (i.e., in the general location of U.S. Route 95 
and Nevada Route 373, near Lathrop Wells). This section also directs 
DOE to use current conditions in the region surrounding Yucca Mountain 
to define the remaining attributes of the critical group.
    Based on analysis to date, the Commission considers a farming 
critical group to be reasonably representative of those individuals 
expected to receive the highest dose from radionuclides released from a 
Yucca Mountain repository for a number of reasons. First, farming 
activities involve more exposure pathways than other known human 
activities in the region (e.g.; ingestion pathway through consumption 
of contaminated water, crops, and animal products; inhalation and 
direct pathways from surface contamination exacerbated by the 
significant outdoor activity of a farming lifestyle). Second, the 
relatively large demand for ground water for irrigation increases the 
likelihood of drawing contaminated water to the surface where human 
exposures could occur. And third, farming activities currently exist in 
the Yucca Mountain region.
    The 20 km location (near Lathrop Wells) represents an informed 
assumption regarding the accessibility of groundwater for irrigation 
considering current irrigation practices, depth to the water table, and 
the recognition that soil conditions at this location are generally 
similar to those further down gradient, near Amargosa Valley, where 
farming is currently practiced. Locations much closer to the proposed 
repository have soil conditions that are considerably less favorable 
for farming. Review of current well use information for Nevada suggests 
that irrigation wells constructed for water table depths greater than 
150 meters are rare. Because well cost is related to depth, it is 
economically preferable to establish irrigation wells in areas where 
the water table is near the surface. The water table at Yucca Mountain 
is deep (i.e., greater than 300 meters) and decreases with distance 
down-gradient, which would also be the eventual path for radionuclide 
releases in the ground-water pathway. The area near U.S. Route 95 and 
Nevada Route 373 is the general location where the depth to water is 
approximately 100 meters with more shallow depths to water occurring 
further south. Because current farming practices are concentrated in 
the Amargosa Farms region (approximately 30 km south of Yucca 
Mountain), the 20 km critical group distance is considered reasonably 
conservative.
    Other activities that currently exist in the area represent more 
limited potential for exposures (e.g., casino resort/hotel, residential 
dwellings). Activities such as residential housing are certainly 
feasible at locations closer than 20 km, where potential release 
concentrations are likely to be higher. However, the bases for 
determining precise locations of such groups are likely to be highly 
speculative, and largely arbitrary, when compared to a farming critical 
group based on existing living patterns. Additionally, the small water 
demand of a residential community, and even smaller demand of a single 
residence, relative to a farming community, further increases the 
uncertainty of dose estimates. Finally, because releases to the 
groundwater are expected to be quite variable spatially, due to the 
characteristics of fractured rock, the likelihood of any particular, 
randomly selected, withdrawal well intercepting contaminated water, at 
a specific location, would be quite small.
    Exposures to the average member of the critical group will increase 
with the amount of contaminated water, crops, and animal products 
consumed, assuming the ground water pathway is the most likely release 
pathway. Individuals expected to receive the highest dose would be 
those for whom locally-produced, contaminated food represents a 
significant fraction of their diet. The Commission is proposing that 
the consumption of locally produced food for the average member of the 
critical group be based on the mean of the range of the dietary habits 
consistent with the current conditions in the Yucca Mountain region. It 
is reasonable to assume that a farming community of

[[Page 8646]]

sufficient size (as opposed to a few isolated farms) would be needed to 
supply the range of locally produced food that is currently consumed in 
the Yucca Mountain region. Such a farming community of up to 100 
individuals, residing on approximately 15 to 25 farms, is consistent 
with current conditions of the region (substantially more farms would 
increase water demand and further decrease radionuclide concentrations 
in pumped water; substantially fewer farms would restrict the 
availability of locally-produced food relative to the regional 
average). Thus, it would be expected that the average member of the 
critical group resides within a farming community and has dietary 
habits which will result in the exposures being among the highest.
    Exposures to the average member of the critical group will also be 
affected by the degree to which the locally produced food is 
contaminated. Variability in farming and water well withdrawal 
practices, as well as the spatial variability of radionuclide 
concentrations in ground water, will produce variation in the amount 
and degree of contamination of locally produced food. The Commission 
considers it desirable to constrain the determination of the 
contamination levels of locally produced food because it is not 
possible to precisely determine concentrations in ground water at 
specific locations or to avoid speculation regarding individual farm 
and water well withdrawal practices. The concentration of radionuclides 
in the water used by a larger farming community, by contrast, can be 
determined by dividing the annual release of radionuclides to the 
location of the farming community by the annual water demands of the 
farming community. For a community of sufficient size, it can be 
assumed that water demand is large enough to ``capture'' the entirety 
of the contaminated plume. Thus, all the locally produced food of the 
farming community would be considered to be contaminated through the 
use of contaminated ground water. The Commission considers this 
reasonable because the average member of the critical group can be 
assumed to consume contaminated food in all categories of locally 
produced food. The use of mean values for defining dietary habits 
ensures that dose estimates would not be unduly biased by unusual 
habits of a few individuals, and speculation is minimized with respect 
to where crops are grown relative to the spatial distribution of 
concentration.
    The biosphere in which the critical group resides affects the 
group's behavior and characteristics and defines how the group could be 
exposed to radionuclide releases from Yucca Mountain. The precise 
future state of the biosphere over the time period considered during a 
performance assessment is highly uncertain. Both natural and man-made 
processes may affect attributes of the biosphere (e.g., climate, 
topography, hydrology and soils), and thereby influencing exposure 
pathways. As noted earlier in this notice, NAS recommended that the 
assumptions about the biosphere make use of present knowledge and be 
cautious, but reasonable.
    The Commission's proposed implementation of the reference biosphere 
concept contains four primary requirements. These include that (i) 
features, events, and processes that describe the reference biosphere 
shall be consistent with present knowledge and conditions in the region 
surrounding the Yucca Mountain site, (ii) biosphere pathways shall be 
consistent with arid or semi-arid conditions, (iii) climate evolution 
shall be consistent with the geologic record of natural climate change 
in the region surrounding Yucca Mountain, and (iv) evolution of the 
geologic setting shall be consistent with present knowledge of natural 
processes.
    Reliance on present knowledge and conditions is considered 
reasonable for development of exposure scenarios because such exposure 
scenarios can be based on empirical knowledge rather than unconstrained 
speculation. The use of current information is intended to place 
primary emphasis on the provision of a framework for analysis of 
repository performance, rather than on the precise prediction of 
possible futures.
    Requirements that the biosphere be based on arid or semiarid 
conditions and that climate evolution be consistent with present 
knowledge of natural climate change reflect a philosophy that, while 
societal behaviors cannot be predicted, certain aspects of the 
evolution of natural systems over long time frames can be predicted 
based on the geologic record. Climate change studies for the Yucca 
Mountain region indicate that the Yucca Mountain climate could become 
cooler and wetter during the next ice age; however, analyses of the 
fossil records from the previous ice age indicate that the climate in 
the area south of Yucca Mountain is likely to change, at most, to 
conditions consistent with a semiarid climate classification. Because 
the current interpretations of the fossil record support these choices 
for local climate now and into the future, it is reasonable to limit 
the scope of assumed climate change to these possibilities. The change 
from arid to semiarid conditions is not expected to alter the biosphere 
sufficiently to cause major changes in potential exposure pathways to 
the critical group. For a farming critical group, a semiarid farming 
region would be expected to support agricultural crops similar to those 
grown in present day Amargosa Valley. Although specific biosphere and 
critical group parameters may change slightly with climate, major 
changes in behavior and exposure pathways for the critical group are 
not assumed.
    DOE will need to establish and defend the particular 
characteristics, behaviors and attributes it assumes for the critical 
group and reference biosphere subject to the requirements and 
specifications of Sec. 63.115. Then, as suggested by ICRP, a 
hypothetical individual representing the average member of the critical 
group, could be established using the mean values of the assumed 
characteristics, behaviors, and attributes. It is expected that DOE 
would conduct a habit survey to establish a realistic range of possible 
characteristics for the critical group, recognizing that its 
assumptions should be internally consistent and should not be driven by 
extreme habits. The Commission believes that its proposal of a farming 
critical group is reasonable for testing the ability of the geologic 
repository to comply with the performance objective at Sec. 63.113 
because it represents cautious, but realistic, assumptions of future 
living patterns in the vicinity of Yucca Mountain based on patterns 
observed there today. As this rulemaking progresses, the Commission's 
ongoing performance assessment analyses will continue to examine the 
influence of important assumptions such as the characteristics of the 
critical group including location, lifestyle, diet, and size. As part 
of this effort, the Commission encourages comments on the 
appropriateness of its proposed approach to defining the critical group 
and reference biosphere for Yucca Mountain. In particular, the 
Commission solicits comments on other candidate population groups, 
biosphere assumptions and potential exposure pathways that should be 
considered in the establishment of a ``critical group'' for Yucca 
Mountain.

VII. Compliance Period

    The NAS recommended that the time over which compliance should be 
assessed should include the time when greatest risk occurs, within the 
limits imposed by the stability of the geologic

[[Page 8647]]

system. This recommendation was founded on technical considerations 
only, and, as NAS acknowledged, did not address issues of policy. In 
selecting the length of time over which the individual dose limit 
should be applied, a regulatory agency must take into account 
technical, policy, and legal considerations. In fact, NAS noted that 
EPA might elect to establish consistent policies for managing 
comparable risks from disposal of long-lived hazardous materials. From 
a technical perspective, for example, the time-dependent variation of 
the hazard, along with the time required to evaluate adequately the 
waste isolation capability of both engineered and natural barriers, are 
of significance. From a policy perspective, on the other hand, the 
practical utility and relative uncertainty of extremely long 
projections of health consequences, along with the need to maintain a 
consistent regulatory approach for like hazards, need to be weighed. 
Having considered both technical and policy concerns, the Commission is 
proposing the use of 10,000 years for evaluating compliance with the 
system performance objective at Sec. 63.113. Should EPA issue final 
standards for Yucca Mountain or Congress enact new high-level waste 
legislation into law that specify a different compliance period, the 
NRC will amend its criteria at 10 CFR Part 63, as necessary, to comply 
with EnPA requirements for consistency with final EPA standards.
    The Commission makes its proposal on the basis of three 
considerations. First, the inherent radiological hazard of spent fuel 
decreases rapidly and significantly during the initial 10,000 years due 
to radioactive decay dominated by fission products, with the relative 
hazard diminished by approximately 90 percent at 100 years, 99 percent 
at about 1,000 years and 99.9 percent at 10,000 years. At 10,000 years 
following waste emplacement, the relative radiological hazard is within 
a factor of ten of the hazard posed by a quantity of 0.2 percent 
uranium ore equivalent to that which was necessary to produce the spent 
fuel (Final Environmental Impact Statement on the Management of 
Commercially Generated Radioactive Waste, DOE, 1980; NRC High-Level 
Radioactive Waste Program Annual Progress Report; Fiscal Year 1996, 
NRC, 1997). Beyond 10,000 years, the relative hazard of the disposed 
waste diminishes very slowly over several hundreds of thousands of 
years because decay at such late times is controlled by the activity of 
longer-lived radionuclides. A 10,000-year compliance period corresponds 
to the time period when the waste is inherently most hazardous.
    Second, analysis of repository performance over 10,000 years 
provides an opportunity to examine the impact of a range of geologic 
conditions (e.g., seismic events, fault movement, igneous activity, and 
climate variation on the scale of global changes due to glaciation) on 
the capability of the engineered and natural barriers to limit 
radiation exposures below the dose limit. It is possible that DOE may 
attempt to demonstrate that its engineered barrier system design is 
sufficiently robust as to preclude any significant releases during a 
10,000-year compliance period. The Commission is aware of DOE's efforts 
to examine a variety of engineered barrier designs that it expects will 
extend the containment period of the waste package. However, the DOE 
has not finalized its repository design and thus it is premature, at 
this time, to assume that the expected lifetime of the engineered 
barrier system will exceed the compliance period. If, indeed, the waste 
package can be shown to preclude radionuclide releases beyond the 
compliance period, a 10,000-year evaluation, it might be argued, would 
only illustrate the effect of the natural system on the degradation of 
the engineered barriers and would fail to adequately display the 
capacity of extant natural barriers to restrict movement of 
radionuclides following release from the waste packages, and thereby, 
limit exposures to members of the critical group. The Commission 
expects that in conducting its performance assessment, DOE will account 
for the susceptibility of some fraction of the more than 7,000 emplaced 
canisters to early failures, attributable to such causes as 
manufacturing defect, lapses in quality assurance programs, etc. The 
ability of the geologic barriers to retard the transport of 
radionuclides released as a result of these early failures would 
clearly need to be evaluated. Furthermore, the assumed intrusion 
scenario specified at Sec. 63.113(d) and discussed later in this notice 
requires a stylized analysis of the consequences of a compromised waste 
package, and will also test the contribution of the geologic barriers 
to overall performance. Irrespective of the projected lifetime of the 
waste package design, the capability of the natural barriers to limit 
exposures would need to be evaluated in the context of the multiple 
barrier requirement.
    Finally, from a policy perspective, EPA has already codified a 
10,000-year compliance period at 40 CFR 191 applicable to the Waste 
Isolation Pilot Plant (WIPP), a similar type of disposal system as that 
proposed at Yucca Mountain. A 10,000-year performance period is also 
referenced in EPA guidance on no-migration petitions for facilities 
seeking exemption from certain land-disposal restrictions for long-
lived hazardous, nonradioactive materials. Additionally, a 10,000-year 
compliance period is specified in NRC's Draft Technical Position on a 
Performance Assessment Methodology for Low-Level Radioactive Waste 
Disposal Facilities (62 FR 29164; May 29, 1997). All of these land 
disposal situations, like HLW disposal, involve disposed wastes 
containing long-lived, hazardous materials which are of concern, 
because they can become mobile in the groundwater pathway.
    The Commission proposes that a 10,000-year compliance period is 
appropriate for evaluating a Yucca Mountain repository because it: (1) 
includes the period when the waste is inherently most hazardous; (2) is 
sufficiently long, such that a wide range of conditions will occur 
which will challenge the natural and the engineered barriers, providing 
a reasonable evaluation of the robustness of the geologic repository; 
and (3) is consistent with other regulations involving geologic 
disposal of long-lived hazardous materials, including radionuclides.

VIII. Multiple Barriers and Defense in Depth

    The defense-in-depth principle has served as a cornerstone of NRC's 
deterministic regulatory framework for nuclear reactors, and it 
provides an important tool for making regulatory decisions, with regard 
to complex facilities, in the face of significant uncertainties. NRC 
also has applied the concept of defense-in-depth elsewhere in its 
regulations to ensure safety of licensed facilities through 
requirements for multiple, independent barriers, and, where possible, 
redundant safety systems and barriers. Traditionally, the reliance on 
independence and redundancy of barriers has been used to provide 
assurance of safety when reliable, quantitative assessments of barrier 
reliability are unavailable. The Commission maintains, as it has in the 
past, that the application of the defense-in-depth concept to a 
geologic repository is appropriate and reasonable. The Commission now 
believes, however, that its implementation, in the context of a 
geologic repository, should be reexamined, in light of the advancement 
in methods to quantitatively assess the

[[Page 8648]]

components of a geologic repository system and with due consideration 
of the Commission's goal of a regulatory program and associated 
requirements that are risk-informed and performance-based.
    Development of NRC's regulations for geologic disposal in 1983 
represented a unique application of the defense-in-depth philosophy to 
a first-of-a-kind type of facility. While waste is being emplaced, and 
before a geologic repository is closed, its operation may be amenable 
to regulation comparable to other operating nuclear fuel cycle 
facilities licensed by NRC. Application of defense-in-depth principles 
for regulation of repository performance, for long time periods 
following closure, however, must account for the difference between a 
geologic repository and an operating facility with active safety 
systems and the potential for active control and intervention. A closed 
repository is essentially a passive system, and assessment of its 
safety over long timeframes is best evaluated through consideration of 
the relative likelihood of threats to its integrity and performance. 
Although it is relatively easy to identify multiple, diverse barriers 
that comprise the engineered and geologic systems, the performance of 
any of these systems and their respective subsystems cannot and should 
not be considered either truly independent or totally redundant.
    As stated earlier, NWPA mandated that technical criteria developed 
by the Commission `` * * * shall provide for the use of a system of 
multiple barriers in the design of the repository.'' How the 
performance of those barriers should be assessed, consistent with the 
Commission's policy of defense-in-depth, was a major issue throughout 
the development and promulgation of the Commission's generic 
regulations at 10 CFR Part 60 and continues to be of concern as the 
Commission contemplates new regulations for Yucca Mountain.
    Well before NWPA was enacted, the Commission had considered the 
appropriate bases for establishing regulations for HLW disposal. In 
developing proposed generic technical criteria for Part 60, the 
Commission placed primary emphasis on the need to compensate for the 
large uncertainty that is inherent in the assessment of the long-term 
performance of HLW disposal systems. The Commission expressed its view, 
then, that the state-of-the-art in the earth sciences was such that all 
the uncertainties related to predicting long-term performance of a 
repository could not be resolved through consideration of the geologic 
setting alone.
    It should be noted that during the late 1970s and early 1980s, when 
the Commission was first considering the development of proposed 
technical criteria for geologic repositories, quantitative techniques 
for assessing repository performance were in their infancy. The lack of 
experience with, and confidence in, quantitative methods for addressing 
the uncertainties associated with estimates of repository performance 
weighed heavily as the Commission considered options for formulating 
generic regulations for HLW disposal. As will be discussed later in 
this statement, the Commission now believes that the application of 
such methods has matured sufficiently to move away from its earlier 
approach.
    As Part 60 was being developed, the Commission gave serious 
consideration to a ``systems approach,'' that is, regulation of a 
repository system through a single figure of merit, that of overall 
system performance, leaving maximum flexibility for determining the 
extent and focus of site characterization, and for the designer to make 
trade-offs among components of the system. It was noted that this 
approach could include a requirement that the system design incorporate 
multiple barriers to compensate for uncertainty in overall system 
performance. It was believed, at the time, however, that compensation 
for uncertainties in assessing the system's overall performance could 
only be achieved by introducing conservatism. Intentional addition of 
conservatism, either by making the measure of performance unduly 
stringent or by using worst-case, bounding assumptions in the 
evaluation, was argued to be impractical from a regulatory point of 
view.
    Instead, the Commission opted to prescribe minimum performance 
standards for each of the major system elements (as they were 
envisioned at the time) as well as to require the overall system to 
comply with the primary performance objective, namely, whatever 
standards EPA would eventually establish. This approach was thought to 
have two advantages over the systems approach, if the barriers were 
chosen judiciously. It was argued that barriers could be prescribed, 
generically, which act ``independently,'' and that generic performance 
measures for these ``independent'' barriers could be selected that 
would reduce calculational uncertainty. Identification of such 
subsystem performance measures was expected to be helpful input to 
DOE's design process, without being overly restrictive. It is now 
recognized that NRC attempted to define such criteria on the basis of 
limited, existing knowledge, without benefit of research and site-
specific information that only later was acquired during 
characterization of a specific site at Yucca Mountain.
    The vast majority of comments received on the proposed Part 60 
favored a ``systems approach.'' Nevertheless, in publishing its final 
rule (48 FR 28194; June 21, 1983), the Commission elected to retain the 
proposed approach, stating that ``* * * in simply adopting the EPA 
standard as the sole measure of performance, it [the Commission] would 
have failed to convey in any meaningful way the degree of confidence 
which it expects must be achieved in order for it to be able to make 
the required licensing decisions' and, further that ``* * * The 
Commission firmly believes that the performance of the engineered and 
natural barriers must each make a definite contribution in order for 
the Commission to be able to conclude that the EPA standard will be 
met.''
    In support of the final rule, the Commission examined how 
particular values for the performance of the proposed barriers would 
assist in concluding that compliance with the EPA standards had been 
demonstrated, given an assumed set of anticipated processes and events. 
Final EPA standards still had not been promulgated, so analyses were 
conducted based on NRC staff assumptions regarding the final standards. 
These analyses, based on a simplified modeling study for a hypothetical 
repository located in a variety of saturated geologic media, were 
documented as NUREG-0804--``Staff Analyses of Public Comments on 
Proposed Rule 10 CFR Part 60, Disposal of High-Level Radioactive Wastes 
in Geologic Repositories.'' For many, but by no means all, of the cases 
examined, compliance with the proposed subsystem performance objectives 
did increase the probability of meeting the assumed EPA standards. NRC 
was not able to demonstrate, however, that compliance with the 
subsystem criteria alone was sufficient to meet the assumed EPA 
standards, nor that compliance with the assumed EPA standards would 
suffice to assure compliance with the subsystem criteria. For the cases 
analyzed, however, it was asserted that the analyses `` * * * 
demonstrate that compliance with 10 CFR Part 60 can substantially 
increase confidence that the assumed EPA standard[s] will be met.''
    Lastly, in order to address concerns that quantitative subsystem 
performance criteria may unduly restrict the

[[Page 8649]]

applicant's flexibility, the Commission modified the proposed rule to 
explicitly recognize the potential need to change the subsystem 
objectives to account for unique features of a specific site or design. 
This flexibility was provided at Sec. 60.113 (b).
    Since their promulgation, the subsystem criteria in Sec. 60.113, in 
particular, have not gained broad acceptance in the technical 
community. These criteria have been criticized as overly prescriptive, 
lacking in both a strong technical basis and a clear technical nexus to 
the overall performance objective (i.e., the EPA standards), and 
unclear in their wording.
    In contrast to the state of performance assessment technology 
assumed at the time Part 60 criteria were put in place, the NAS 
Committee on Technical Bases for Yucca Mountain Standards found, in 
1995, that the physical and geologic processes relevant to a Yucca 
Mountain repository: ``* * * are sufficiently quantifiable and the 
related uncertainties sufficiently boundable that the performance [of a 
repository] can be assessed over timeframes during which the geological 
system is relatively stable or varies in a boundable manner.'' As has 
been described earlier, it was a lack of confidence in this capability 
to quantify overall performance and adequately bound uncertainty that 
factored prominently in the Commission's decision to include 
quantitative subsystem requirements in the Part 60 regulations. Also, 
as discussed earlier, NAS cautioned against implementation of multiple 
barriers through the use of subsystem performance requirements. In 
addition, the Commission's Advisory Committee on Nuclear Waste (ACNW) 
recently recommended that the Commission implement the concept of 
defense in depth by ensuring that the effectiveness of individual 
barriers be identified explicitly in the total system performance 
assessment (TSPA), but specifically did not endorse the establishment 
of rule-based subsystem requirements for Yucca Mountain. The ACNW noted 
that ``* * * an overall performance-based regulation in the context of 
a risk-based standard is a superior tool for promoting safety relative 
to imposed subsystem requirements. (see letters dated October 31, 1997 
and March 6, 1998).''
    Upon review of this regulatory history, the Commission is persuaded 
that much of the basis for NRC's initial development of the specific 
numerical values for the subsystem criteria was generic judgment with 
regard to what was (and was not) feasible with regard to the 
quantitative assessment of long-term repository performance. Because 
the stated goal was to compensate for uncertainty, there was never any 
attempt to derive the subsystem performance criteria from a specified 
dose or risk level or from some projected dose or risk reduction 
expected to be achieved by their application. Furthermore, after 15 
years of experience in working with the requirements of Part 60, the 
Commission is concerned that, for the Yucca Mountain site, the 
application of the subsystem performance criteria at Sec. 60.113 may 
impose significant additional expenditure of resources on the nation's 
HLW program, without producing any commensurate increase in the 
protection of public health and safety.
    Specifically, when the Part 60 subsystem criteria were selected, 
they were intended to be separate, ``independent,'' easily-determined 
measures of subsystem performance, determination of which would require 
only application of technology that was readily available. Extensive 
experience with site-specific performance assessment has shown them to 
be none of these. For example, because container performance, release 
rate, and ground-water travel time will be derived from the same 
general data and knowledge base as the TSPA, they are subject to many, 
if not all, of the same uncertainties. Furthermore, waste package 
performance and release rate are both a function of available water; 
therefore, it is arguable whether the existing (or any other) subsystem 
measures can provide truly independent assurance of total system 
performance.
    Nevertheless, despite its reconsideration of the merits of 
establishing quantitative criteria for the performance of repository 
subsystems, the Commission continues to believe that multiple barriers, 
as required by NWPA, must each make a definite contribution to the 
isolation of waste at Yucca Mountain, so that the Commission may find, 
with reasonable assurance, that the repository system will be able to 
achieve the overall safety objective over timeframes of thousands of 
years. Geologic disposal of HLW is predicated on the expectation that a 
portion of the geologic setting will act as a barrier, both to water 
reaching the waste, and to dissolved radionuclides migrating away from 
the repository, and thus, contribute to the isolation of radioactive 
waste. Although there exists an extensive geologic record ranging from 
thousands to millions of years, this record is subject to 
interpretation and includes many uncertainties. These uncertainties can 
be quantified generally and are addressed by requiring the use of a 
multiple barrier approach; specifically, an engineered barrier system, 
consisting of one or more distinct engineered barriers, is required in 
addition to the natural barriers implicit in a geologic setting. 
Similarly, although the composition and configuration of engineered 
structures, as well as their capacity to function as barriers, can be 
defined with a degree of precision not possible for natural barriers, 
it is recognized that except for a few archaeologic analogues, there is 
no experience base for the performance of complex, engineered 
structures over periods longer than a few hundred years. It is expected 
that DOE will demonstrate that the natural barriers and the engineered 
barrier system will work in combination to enhance overall performance 
of the geologic repository.
    The Commission believes that this approach to multiple barriers is 
consistent with the NAS conclusions and recommendations cited above. 
The Commission also recognizes, and believes it is important to 
acknowledge that experience and improvements in the technology of 
performance assessment, acquired over more than 15 years, now provide 
significantly greater confidence in the technical ability to assess 
comprehensively overall repository performance, and to address and 
quantify the corresponding uncertainty. In addition to extensive 
reviews of evolving TSPAs produced by DOE and its contractors, the 
Commission, itself, has developed and exercised its own technical 
capability in the field of repository performance assessment (See, for 
example, Bonano, E. J., et al., ``Demonstration of a Performance 
Assessment Methodology for High-Level Waste Disposal in Basalt 
Formation,'' NUREG/CR-4759, U.S. Nuclear Regulatory Commission, 
Washington, DC, 1989; ``Initial Demonstration of the NRC's Capability 
to Conduct a Performance Assessment for a High-Level Waste 
Repository,'' NUREG-1327, 1992; ``NRC Iterative Performance Assessment 
Phase 2--Development of Capabilities for Review of a Performance 
Assessment for a High-Level Waste Repository,'' NUREG-1464, 1995).
    Drawing from this experience, the Commission is now proposing to 
require that DOE evaluate the behavior of barriers important to waste 
isolation in the context of the performance of the geologic repository. 
The Commission does not intend to specify numerical goals for the 
performance of individual barriers. Such an approach will require DOE 
to provide an analysis that: (1)

[[Page 8650]]

identifies those design features of the engineered barrier system, and 
natural features of the geologic setting, that are considered barriers 
important to waste isolation; (2) describes the capability of these 
barriers to isolate waste, taking into account uncertainties in 
characterizing and modeling the barriers; and (3) provides the 
technical basis for the description of the capability of these 
barriers. In implementing this approach, the Commission proposes to 
incorporate flexibility into its regulations by requiring DOE to 
demonstrate that the geologic repository comprises multiple barriers 
but not prescribe which barriers are important to waste isolation or 
the methods to describe their capability to isolate waste.
    DOE could select from a variety of methods in order to demonstrate 
the capability of barriers to isolate waste. Regardless of the method 
and the level of quantification, it is expected that the capability of 
individual barriers to perform their intended function and the 
relationship of that function to limiting radiological exposure would 
be described. In parallel with this rulemaking, NRC staff is developing 
guidance in the form of a Yucca Mountain Review Plan. In this review 
plan, guidance will be provided on acceptable methods for demonstrating 
compliance with the multiple barrier requirement that could include, 
but not necessarily be limited to, performing sensitivity analyses, 
modeling the behavior of individual barriers, quantifying how 
individual barriers contribute to performance, and delineating the 
capabilities of the barriers to isolate waste. The Commission believes 
that it is appropriate to afford DOE flexibility in selecting the 
methods to demonstrate the waste isolation capability of the multiple 
barriers that must comprise its repository design. The proposed 
requirements will provide for a system of multiple barriers and an 
understanding of the resiliency of the geologic repository provided by 
the barriers important to waste isolation to ensure defense in depth 
and increase confidence that the postclosure performance objective will 
be achieved.

IX. Performance Assessment

    Demonstration of compliance with the postclosure performance 
objective specified at Sec. 63.113(b) requires a performance assessment 
that quantitatively estimates the expected annual dose, over the 
compliance period and weighted by probability of occurrence, to the 
average member of the critical group. Performance assessment is a 
systematic analysis of what can happen at the repository after 
permanent closure, how likely it is to happen, and what can result, in 
terms of dose to the average member of the critical group. Taking into 
account, as appropriate, the uncertainties associated with data, 
methods, and assumptions used to quantify repository performance, the 
performance assessment is expected to provide a quantitative evaluation 
of the overall system's ability to achieve the performance objective 
(Sec. 63.113 (b)). Consistent with EnPA and the NAS recommendations, 
the Commission proposes that the results of performance assessment 
shall be the sole quantitative measure used to demonstrate compliance 
with the postclosure individual dose limit.
    In order to find that issuance of a license will not constitute an 
unreasonable risk to the health and safety of the public, the 
Commission must have reasonable assurance that the required performance 
assessment has demonstrated that, following permanent closure, for the 
duration of the compliance period and considering the likelihood of 
occurrence of adverse natural events, expected annual exposures to the 
average member of the critical group will not exceed the individual 
dose limit of .25 mSv (25 mrem) TEDE. Although the performance 
objective for the geologic repository after permanent closure 
(Sec. 63.113) is generally stated in unqualified terms, it is not 
expected that complete assurance that the requirement will be met can 
be presented. A reasonable assurance, on the basis of the record before 
the Commission, that the performance objective will be met is the 
general standard that is required. Proof that the geologic repository 
will be in conformance with the objective for postclosure performance 
is not to be had in the ordinary sense of the word because of the 
uncertainties inherent in the understanding of the evolution of the 
geologic setting, biosphere, and engineered barrier system. For such 
long-term performance, what is required is reasonable assurance, making 
allowance for the time period, hazards, and uncertainties involved, 
that the outcome will be in conformance with the objective for 
postclosure performance of the geologic repository. Demonstrating 
compliance, by necessity, will involve the use of complex predictive 
models that are supported by limited data from field and laboratory 
tests, site-specific monitoring, and natural analog studies that may be 
supplemented with prevalent expert judgment. Further, in reaching a 
determination of reasonable assurance, the Commission may supplement 
numerical analyses with qualitative judgments including, for example, 
consideration of the degree of diversity or redundancy among the 
multiple barriers of the geologic repository.
    Because of the significance of the performance assessment as the 
sole quantitative measure of compliance, it is essential that the 
performance assessment be scientifically defensible and transparent. 
For this reason, the Commission considers it important to specify, at 
Sec. 63.114, requirements for a complete and high-quality performance 
assessment. A defensible performance assessment should contain a 
technical rationale for those features, events, and processes that have 
been included in the performance calculation, as well as those that 
have been considered but were excluded. The features, events, and 
processes (i.e., specific conditions or attributes of the geologic 
setting; degradation, deterioration, or alteration of the engineered 
barriers; and interactions between the natural and engineered barriers) 
considered for inclusion in the assessment should represent a wide 
range of beneficial and detrimental effects on performance. Features, 
events, and processes should be considered in light of available data 
and current scientific understanding, and alternative conceptual models 
that are consistent with such data and understanding should be 
evaluated. Inclusion of alternative models should be based, however, on 
reasonable interpretation of available information, and should not be 
driven by open-ended speculation. To this end, the Commission is 
proposing to constrain speculation by defining a lower limit on the 
probability of events and processes that need to be considered and 
requiring inclusion of only those features and processes, and higher 
probability events that significantly change the expected annual dose.
    The performance assessment will rely, by necessity, on computer 
modeling to determine whether a proposed geologic repository meets the 
performance objectives. Such reliance on computer simulation has become 
commonplace for determining the likely performance of complex 
engineered systems. In most applications, it is accompanied by a 
rigorous testing program, involving model ``validation'' and 
``verification,'' to ensure that the simulated system behavior is 
sufficiently consistent with empirically observed behavior to meet the 
need of the application at hand. The Commission expects that DOE will 
take

[[Page 8651]]

reasonable and practical measures to ensure that its performance 
assessment provides a credible representation of a geologic repository 
at Yucca Mountain. For example, assurance of the soundness of the 
performance assessment cannot and will not involve the comparison of 
simulated behavior of a geologic repository with empirical observation 
over tens of kilometers and tens of thousands of years. At best, 
assurance for the performance assessment will involve comparison of 
simulations with observations drawn from an integrated program of 
laboratory tests, field tests, and analog studies that starts with site 
characterization and continues, as appropriate, through the performance 
confirmation period. To the extent that DOE's performance assessment 
provides a credible representation of a geologic repository, the 
Commission expects no more than that and believes that no more is 
needed. When the NWPA became law in 1982, and when it was revisited in 
1987, and again in 1992, the limits on human knowledge that are 
attendant to confirming performance of a geologic repository were well 
known. The Commission does not believe that these laws were passed with 
the intention of creating an impossible task. Accordingly, the 
Commission has included, at Secs. 63.101(a)(2) and 63.101(b), 
explanations regarding the purpose and nature of the findings it will 
make.
    To be transparent, DOE's performance assessment must contain an 
evaluation of the performance of the geologic repository relative to 
compliance with the individual dose limit and an explanation of how the 
estimated performance was achieved. Section 63.113(b) requires that 
compliance with the individual dose limit be demonstrated through the 
calculation of an expected annual dose. The expected annual dose is the 
expected value of the annual dose considering the probability of the 
occurrence of the events and the uncertainty, or variability, in 
parameter values used to describe the behavior of the geologic 
repository (the expected annual dose is calculated by accumulating the 
dose estimates for each year, where the dose estimates are weighted by 
the probability of the events and the parameters leading to the dose 
estimate). Demonstration of compliance with the individual dose limit 
will need to include an estimate of the expected annual dose to the 
average member of the critical group that, for any single year within 
the compliance period, is below the limit. Explanation of how the 
estimated performance was achieved should reveal an understanding of 
the relationship between the performance of individual components or 
subsystems of the geologic repository and the total system performance. 
Such understanding would be used to build confidence that the expected 
annual dose, as asserted in the license application, is a reasonable 
estimate of the performance of the geologic repository. Consistent with 
a performance-based philosophy, the Commission proposes to permit DOE 
the flexibility to select the approach for demonstrating this 
relationship that is most appropriate to its analysis.

X. Institutional Controls

    The Commission is proposing to require DOE to institute active, as 
well as passive, control measures to reduce the potential for 
inadvertent human intrusion into the site. Reasonably prudent, active 
institutional controls, consistent with the requirements of Section 
801(c) of EnPA, should be maintained at the site for as long as 
possible. The Commission is also proposing that DOE's passive control 
measures should be designed to serve their intended purpose for as long 
as practicable.
    Section 801(b) of EnPA requires that:
    * * * the Commission's requirements assume, to the extent 
consistent with the findings and recommendations of the National 
Academy of Sciences, that following repository closure, the inclusion 
of engineered barriers and the Secretary's postclosure oversight of the 
Yucca Mountain Site, in accordance with Subsection (c) shall be 
sufficient to:
    (A) prevent any activity at the site that poses an unreasonable 
risk of breaching the repository's engineered or geologic barriers; and
    (B) prevent any increase in the exposure of individual members of 
the public to radiation beyond allowable limits.
    However, as was discussed earlier in this notice, NAS concluded 
that it is not reasonable to assume that a system for postclosure 
oversight, based on active institutional controls, can be developed 
that will eliminate entirely, over thousands of years, the possibility 
of human activity that could degrade the long-term performance of the 
repository.

XI. Human Intrusion

    The geologic record provides a basis for evaluating the likelihood 
of geologic processes and events, but no similar record of extended 
duration exists that can be used to constrain either the probability 
that human intrusion could occur or the characteristics of such 
intrusion. Although designs can seek to warn potential intruders or to 
mitigate effects associated with intrusion that does occur, they cannot 
remove the potential for intrusion to occur. Similarly, repositories 
cannot be designed to mitigate the full range of possible ways that 
human intrusion could occur. Therefore, the Commission is proposing to 
require that DOE take reasonable and prudent steps to reduce the 
likelihood of human intrusion, and that DOE's repository design must 
still perform as intended, if an assumed, limited intrusion does occur.
    As noted earlier, the NAS also concluded that it is not possible to 
make scientifically supportable predictions of the probability of human 
intrusion breaching the repository's geologic or engineered barriers 
over a period of 10,000 years. The NAS report recommended that human 
intrusion be excluded from the performance assessment, but that the 
consequences of an assumed human intrusion scenario should be 
calculated to determine if repository performance would be 
substantially degraded as a result of the intrusion.
    The Commission agrees with the NAS recommendations to consider 
human intrusion apart from the risk-based performance assessment. To 
permit consideration of the potential detriment from human intrusion in 
the evaluation of repository performance, the Commission proposes that 
DOE be required to perform a consequence analysis that includes an 
assumed intrusion scenario as specified at Sec. 63.113(d). This 
consequence analysis would be identical to the performance assessment, 
except that a specified human intrusion scenario is assumed to occur. 
In the event of this assumed scenario, the repository is required to 
perform such that the expected annual dose to the average member of the 
critical group is also within allowable limits. Hazards to the 
intruders themselves (drillers, miners, etc.) or to the public from 
material brought to the surface by the assumed intrusion should not be 
included in this analysis, according to NAS. This is because, NAS 
asserts, analyses of these hazards would be unlikely to provide any 
useful basis for judging the resilience of a particular repository or 
design to intrusion.
    The Commission does not intend to speculate on the virtual infinity 
of human intrusion scenarios that could be contemplated, nor does it 
intend for this analysis to address the full range of possible 
intrusions that could occur. Rather, the Commission intends that this 
analysis show that the repository exhibits some resilience to a breach 
of

[[Page 8652]]

engineered and geologic barriers from events that are reasonably of 
concern. Therefore, the Commission is proposing an assumed human 
intrusion scenario that results in the breach of both engineered and 
geologic barriers. The Commission believes that current practices 
provide a solid basis for establishing properties for the intrusion 
scenario that avoid speculation. Therefore, the Commission is proposing 
that DOE use current practices for resource exploration to establish 
properties (e.g., diameter of the borehole, drilling rate, composition 
of drilling fluids) for the intrusion scenario. However, because the 
Commission intends for this analysis to show that the repository can 
still adequately perform if its barriers are breached, the Commission 
is requiring DOE to assume that the borehole is not adequately sealed 
to prevent infiltrating water.
    Elsewhere in its regulations (e.g., 10 CFR Part 60), the Commission 
has limited the extent to which reliance may be placed on active 
institutional controls to prevent unacceptable radiological exposures 
from the disposal of other radioactive wastes. Consistent with this 
approach, the Commission is proposing that the intrusion scenario be 
assumed to occur 100 years after repository closure.
    The Commission is mindful that a single stylized intrusion scenario 
should not be taken as a prediction of the likely manner or frequency 
of intrusion. As NAS stated in its report, a ``calculation of 
consequences for such an intrusion removes from consideration a number 
of imponderables, each of which would otherwise need to be treated 
separately, including the probability that an intrusion borehole would 
intersect a waste canister, the probabilities of detection and 
remediation, and the effectiveness of institutional controls and 
markers to prevent intrusion. This scenario should not be interpreted 
as either an optimistic or pessimistic estimate of what might actually 
occur * * * We believe that the simplest scenario that provides a 
measure of the ability of the repository to isolate waste and thereby 
protect the public is the most appropriate scenario to use for this 
purpose.''
    Bearing this in mind, the Commission solicits comment on the 
appropriateness of its proposed intrusion scenario, and the assumed 
timing of its occurrence, as a reasonable measure for evaluating the 
consequences of intrusion at a repository at Yucca Mountain.

XII. Preclosure Performance Objective

    The Commission is proposing performance objectives at Sec. 63.111 
to ensure that the geologic repository operations area is designed and 
operated to protect against radiation exposures and releases of 
radioactivity prior to permanent closure. Specifically, protection of 
the worker and general public is ensured by requiring that (1) the 
exposure limits codified at 10 CFR Part 20 are maintained, and (2) 
during normal operations and anticipated operational occurrences, the 
annual dose to any real member of the public, located beyond the 
boundary of the site, shall not exceed a TEDE of 0.25 mSv (25 mrem). 
The 0.25 mSv (25 mrem) limit was included to provide consistency with 
requirements for the MRS and other waste management facilities (e.g., 
40 CFR 191.03(a), 10 CFR 72.104, and 10 CFR 61.40). Additionally, 
numerical guides for design objectives have been specified for Category 
1 design basis events and Category 2 design basis events. Category 1 
design basis events are those events that are expected to occur one or 
more times before permanent closure. Included in Category 1 design 
basis events are events that occur regularly or moderately frequently, 
and that are sometimes identified as ``normal operations'' associated 
with receiving, handling, packaging, storing, emplacing, and retrieving 
high-level waste. Also included in Category 1 design basis events are 
those events that occur one or more times during the operating lifetime 
of a facility, and that are sometimes identified as ``anticipated 
operational occurrences'' or ``accidents.'' Category 2 design basis 
events are those events that have at least one chance in 10,000 of 
occurring before permanent closure. For an operational period of 100 
years, this corresponds to an annual probability of occurrence of 
10-6. Category 2 design basis events are unlikely, but 
credible and potentially significant events. The Commission 
incorporated similar definitions of design basis events and associated 
dose limits in its generic regulations at 10 CFR Part 60 (61 FR 64257) 
for evaluation of preclosure repository performance. The primary 
purpose of those most recent amendments to the Commission's generic 
criteria, in addition to achieving greater consistency with Part 72 
requirements, was to improve clarity and sufficiency of the 
requirements to protect health and safety for the full range of 
credible conditions or events that could occur at an operating 
repository, including low-probability events that have potentially 
serious consequences. The Commission believes that the performance 
objectives established by these amendments are suitable for inclusion 
in its proposed criteria for preclosure operation at a Yucca Mountain 
repository.

XIII. Integrated Safety Analysis of Activities at the Geologic 
Repository Operations Area

    The Commission is proposing that compliance with the preclosure 
performance objectives would be demonstrated through an integrated 
safety analysis (ISA) of the geologic repository operations area 
(GROA). The ISA is a systematic examination of potential hazards at the 
GROA. It identifies the potential hazards, the potential for initiating 
event sequences, and describes potential event sequences and their 
consequences, as well as the site, structures, systems, components, 
equipment, and activities of personnel intended to mitigate or prevent 
the accident sequence. Its purpose is to ensure that all relevant 
hazards that could result in unacceptable consequences have been 
adequately evaluated and appropriate protective measures have been 
identified such that the GROA will comply with the preclosure 
requirements for protection against radiation exposures and releases of 
radioactive material specified in Sec. 63.111. As used here, integrated 
means joint consideration of safety measures that, considered 
separately, might not achieve the overall health and safety protection 
desired. Such integration would include, but not be limited to, 
integration of fire protection, radiation safety, criticality safety, 
and chemical safety measures.
    A fundamental aspect of the ISA is the identification and analysis 
of Category 1 and Category 2 design basis events. Category 1 events as 
described above represent ``normal operations'' while Category 2 events 
represent unlikely but credible events which would challenge the design 
of the GROA to maintain exposures within allowable limits. The analysis 
of a specific Category 2 design basis event would include an initiating 
event (e.g., an earthquake) and the associated combinations of 
repository system or component failures that can potentially lead to 
exposure of individuals to radiation. An example design basis event is 
a postulated earthquake (the initiating event) which results in (1) the 
failure of a crane lifting a spent fuel waste package inside a waste 
handling building, (2) damage to the building ventilation (filtration) 
system, (3) the drop and breach of the waste package, (4) damage to the 
spent fuel, (5)

[[Page 8653]]

partitioning of a fraction of the radionuclide inventory to the 
building atmosphere, (6) release of some radioactive material through 
the damaged ventilation (filtration) system, and (7) exposure of an 
individual (either a worker or a member of the public) to the released 
radioactive material.
    The Commission believes the proposed approach, which does not 
include specification of general design criteria, is appropriate 
because prescriptive design criteria may unnecessarily encumber DOE, 
given the ongoing nature of site characterization of the underground 
facility and evolution of facility design. The information the 
Commission needs to make a finding of reasonable assurance that the 
GROA will comply with the risk-informed, preclosure requirements at 
Sec. 63.111, will be provided by the ISA. The Commission proposes 
criteria, at Sec. 63.112, for the content of the ISA.

XIV. Quality Assurance

    As is currently required by the generic criteria at 10 CFR Part 60, 
the Commission is proposing that DOE implement a quality assurance 
program, for the geologic repository, based on the criteria of Appendix 
B of 10 CFR Part 50. Although an essentially equivalent quality 
assurance program for the independent storage of spent nuclear fuel and 
HLW is specified at Subpart G of 10 CFR Part 72, the Commission 
believes it to be appropriate to continue to reference Appendix B for 
the geologic repository at Yucca Mountain for purposes of maintaining 
continuity between data collected, during site characterization, 
pursuant to Part 60 requirements and those that will be collected once 
Part 63 requirements take effect. The Commission is seeking comment on 
the merits of this approach.

XV. Emergency Planning

    When the Commission published final generic criteria for geologic 
disposal in 1983, licensing requirements for emergency planning were 
reserved for a later date. On June 22, 1985 (60 FR 32430), the 
Commission published final amendments to 10 CFR Part 72 that codified 
generic emergency planning licensing requirements for independent spent 
fuel storage installations (ISFSIs) and monitored retrievable storage 
facilities (MRS). These amendments provided for enhanced requirements 
for offsite emergency planning at MRS facilities (as well as at any 
ISFSIs that conduct similar operations) because of the broader scope of 
activities that could be performed at these facilities relative to 
those conducted at simpler storage installations. Like an MRS facility, 
a Geologic Repository Operations Area (GROA) at Yucca Mountain is 
expected to be a large industrial facility equipped to handle the 
loading, unloading, and decontamination of a large number of spent fuel 
and HLW shipping casks arriving by rail, heavy haul, and legal weight 
truck. It will also include facilities to open shipping canisters that 
are unsuitable for disposal, as well as to package bare fuel 
assemblies, commercial and defense spent fuel, and commercial and 
defense HLW in disposable canisters, and seal them for emplacement in 
the repository. Packaging operations will be conducted in a 
radiologically-controlled area that can support remote dry and pool-
handling operations. At this time, a final GROA design has not been 
selected by DOE.
    In promulgating final amendments at 10 CFR Part 72, the Commission 
conducted an analysis of potential onsite and offsite consequences of 
accidental release associated with the operation of an MRS. This 
analysis is contained in NUREG-1092. Because the activities 
contemplated for the GROA prior to repository closure pose similar 
radiological hazards to those analyzed for operations at an MRS, the 
Commission is proposing that the emergency planning licensing 
requirements for preclosure operations at the Yucca Mountain repository 
be comparable to those already codified in Sec. 72.32 (b). Therefore, 
the Commission is proposing to require, at Subpart I, Sec. 63.161, that 
DOE develop, and be prepared to implement, a plan to cope with 
radiological emergencies that may occur at the GROA prior to permanent 
closure, that is based on the criteria of Sec. 72.32(b).

XVI. Changes, Tests and Experiments

    The Commission is proposing to set out, at Sec. 63.44, the bases on 
which DOE may change the geologic repository operations area or 
procedures as described in the application, and conduct tests or 
experiments not described in the application, without prior Commission 
approval. DOE would be required to maintain records of changes made and 
tests undertaken pursuant to this section. Comparable provisions exists 
at 10 CFR 50.59 for licensees of production and utilization facilities 
(e.g. nuclear reactors) and at 10 CFR 72.48 for licensees of facilities 
for the independent storage of spent nuclear fuel and HLW. The intent 
of these requirements is to permit licensees to make changes, or to 
conduct tests at a licensed facility, provided that: the changes 
maintain the level of safety documented in the original licensing basis 
(such as in the safety analysis report); the changes do not alter a 
license condition; and the changes do not introduce a previously 
unreviewed safety question.
    Recently, the Commission proposed amendments to Parts 50 and 72 (63 
FR 56098; October 21, 1998), to address a number of issues concerning 
the implementation of these provisions for reactors and independent 
spent fuel storage facilities. In particular, the proposed amendments 
attempt to revise criteria for determining when an unreviewed safety 
question exists. The Commission has become concerned that differing 
interpretations of these requirements as they relate to an increase in 
the probability of an accident, or an increase in consequences, have 
contributed to disputed inspection and enforcement findings. Too 
stringent an interpretation of the meaning of the requirements could 
result in diversion of licensee and NRC resources for review of 
inconsequential changes. Too high a threshold for NRC approval could 
lead to an erosion of safety without explicit NRC review, particularly 
with respect to the cumulative effect of multiple changes.
    The Commission acknowledges that these issues are still under 
review within the Commission, and may well undergo further modification 
based upon that review or on public comments received. That being said, 
the Commission sees merit in the establishment of a uniform policy 
approach for addressing the change process issue. To this end, at the 
same time the Commission solicits comment on proposed requirements at 
Sec. 63.44 that are comparable to existing regulations for other 
facilities, the Commission also seeks comment on the suitability, for a 
repository at Yucca Mountain, of an approach substantially equivalent 
to that proposed last year for nuclear reactors and spent fuel storage 
facilities. Alternative criteria for Sec. 63.44, that could be used to 
implement such an approach for a repository at Yucca Mountain, is 
presented below, and should be viewed as a template for discussion.

Section 63.44 Changes, Tests, and Experiments

    (a) Definitions:
    (1) Change means a modification, addition or removal.
    (2) Final Safety Analysis Report (as updated) means the Safety 
Analysis Report for the geologic repository, submitted in accordance 
with Sec. 63.21, as modified as a result of changes made

[[Page 8654]]

pursuant to Sec. 63.44, and as updated in accordance with Sec. 63.24.
    (3) Procedures as described in the Final Safety Analysis Report (as 
updated) means information in the Final Safety Analysis Report (as 
updated) regarding how structures, systems, and components important to 
safety are operated or controlled and information describing conduct of 
operations.
    (4) Reduction in margin of safety associated with any license 
specification means that the input assumptions, analytical methods, 
acceptance conditions, criteria and limits of the safety analyses, 
presented in the Final Safety Analysis Report (as updated), that 
established any license specification requirement, are altered in a 
nonconservative manner.
    (5) Tests or experiments not described in the Final Safety Analysis 
Report (as updated) means any condition where the geologic repository 
operations area or any of its systems, structures, and components 
important to safety, or barriers important to waste isolation, are 
utilized, controlled, or altered in a manner which is either:
    (i) Outside the controlling parameters of the design bases as 
described in the Final Safety Analysis Report (as updated); or
    (ii) Inconsistent with the analyses in the Final Safety Analysis 
Report (as updated).
    (b)(1) DOE may make changes in the geologic repository operations 
area as described in the Final Safety Analysis Report (as updated), 
make changes in the procedures as described in the Final Safety 
Analysis Report (as updated), and conduct tests or experiments not 
described in the Final Safety Analysis Report (as updated), without 
obtaining either an amendment of construction authorization pursuant to 
Sec. 63.33 or a license amendment pursuant to Sec. 63.45, if a change 
in the conditions incorporated in the construction authorization or 
license is not required, and the change, test, or experiment does not 
meet any of the criteria in paragraph (b)(2) of this section.
    (2) DOE shall obtain an amendment of construction authorization 
pursuant to Sec. 63.33 or a license amendment pursuant to Sec. 63.45, 
prior to implementing a change, test, or experiment if it would:
    (i) Result in more than a minimal increase in the probability of 
occurrence of an event previously evaluated in either the Final Safety 
Analysis Report (as updated), or in evaluations performed pursuant to 
this section and safety analyses performed pursuant to Secs. 63.33 or 
63.45, as applicable, after the last Final Safety Analysis Report was 
updated pursuant to Sec. 63.24;
    (ii) Result in more than a minimal increase in the probability of 
occurrence of a malfunction of structures, systems, components 
important to safety, or barriers important to waste isolation, which 
were previously evaluated in either the Final Safety Analysis Report 
(as updated), or in evaluations performed pursuant to this section and 
safety analyses performed pursuant to Secs. 63.33 or 63.45, as 
applicable, after the last Final Safety Analysis Report was updated 
pursuant to Sec. 63.24;
    (iii) Result in more than a minimal increase in the consequences of 
an event previously evaluated in either the Final Safety Analysis 
Report (as updated), or in evaluations performed pursuant to this 
section and safety analyses performed pursuant to Secs. 63.33 or 63.45, 
as applicable, after the last Final Safety Analysis Report was updated 
pursuant to Sec. 63.24;
    (iv) Result in more than a minimal increase in the consequences of 
malfunction of structures, systems, components important to safety, or 
barriers important to waste isolation, which were previously evaluated 
in either the Final Safety Analysis Report (as updated), or in 
evaluations performed pursuant to this section and safety analyses 
performed pursuant to Secs. 63.33 or 63.45, as applicable, after the 
last Final Safety Analysis Report was updated pursuant to Sec. 63.24;
    (v) Create the possibility for a design basis event, or of a 
pathway for release of radionuclides, of a different type than any 
evaluated previously in either the Final Safety Analysis Report (as 
updated), or in evaluations performed pursuant to this section and 
safety analyses performed pursuant to Secs. 63.33 or 63.45, as 
applicable, after the last Final Safety Analysis Report was updated 
pursuant to Sec. 63.24;
    (vi) Create the possibility for a malfunction of structures, 
systems, and components important to safety, or barriers important to 
waste isolation, with a different result than any evaluated previously 
in either the Final Safety Analysis Report (as updated), or in 
evaluations performed pursuant to this section and safety analyses 
performed pursuant to Secs. 63.33 or 63.45, as applicable, after the 
last Final Safety Analysis Report was updated pursuant to Sec. 63.24;
    (vii) Result in a reduction in the margin of safety associated with 
any license specification;
    (viii) Result in a significant increase in occupational exposure;
    (ix) Result in a significant unreviewed environmental impact.
    (c)(1) DOE shall maintain records of changes in the geologic 
repository operations area at the Yucca Mountain site and of changes in 
procedures it has made pursuant to this section if these changes 
constitute changes in the geologic repository operations area as 
described in the Final Safety Analysis Report (as updated). DOE shall 
also maintain records of tests and experiments carried out pursuant to 
paragraph (b) of this section. These records shall include a written 
evaluation that provides the bases for the determination that the 
change, test, or experiment does not require an amendment of 
construction authorization or license amendment pursuant to paragraph 
(b)(2) of this section.
    (2) DOE shall prepare annually, or at such shorter interval as may 
be specified in the license, a report containing a brief description of 
such changes, tests, and experiments, including a summary of the 
evaluation of each. DOE shall furnish the report to the appropriate NRC 
Regional Office shown in Appendix D of Part 20 of this chapter, with a 
copy to the Director, Office of Nuclear Material Safety and Safeguards, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555. Any report 
submitted pursuant to this paragraph shall be made a part of the public 
record of the licensing proceedings.
    As noted above, the criteria for changes, tests and experiments 
that a licensee may conduct without prior NRC approval or license 
amendment continue to be the subject of generic consideration by the 
Commission, and may change subject to public comment received on this 
notice, or on the proposed rulemaking for Parts 50 and 72, discussed 
earlier. For example, in the supplementary information accompanying the 
latter, the Commission identified a range of possible definitions for 
what may constitute a ``reduced margin of safety,'' including its 
deletion as a criterion. Also, it should be noted that, depending on 
the outcome of the Commission's generic deliberations, it may be 
necessary to modify Secs. 63.44 and 63.46, as proposed in this notice, 
to eliminate, altogether, the concept of an ``unreviewed safety 
question.''
    Irrespective of the specific approach and criteria selected, the 
Commission is also interested in whether criteria for changes, tests 
and experiments should apply solely to the Safety Analysis Report or to 
the contents of the entire license application, as proposed.

[[Page 8655]]

XVII. Relationship to Generic Criteria at 10 CFR Part 60

    The proposed criteria will apply specifically and exclusively to 
the proposed repository at Yucca Mountain. Consistent with this intent, 
the Commission proposes to modify its generic criteria at 10 CFR Part 
60 to make clear that they do not apply, nor may they be the subject of 
litigation, in any NRC licensing proceeding for a repository at Yucca 
Mountain.
    Corresponding administrative changes to Parts 2, 19, 20, 21, 30, 
40, 51, and 61 are being proposed to reflect the potential of licensing 
a HLW geologic repository under proposed Part 63 as well as Part 60. In 
appropriate sections of Parts 2, 19, 20, 21, 30, 40, 51, and 61 where 
Part 60 is mentioned, a reference to Part 63 is added. 2
---------------------------------------------------------------------------

    \2\  Although the NRC has recently published final rule 
amendments to update its rules of practice in Subpart J of Part 2 
for the licensing proceeding on disposal of HLW at a geologic 
repository (62 FR 71729; December 30, 1998), any further changes to 
Subpart J that are necessary to conform to the addition of Part 63 
will be deferred until completion of this rulemaking.
---------------------------------------------------------------------------

XVIII. Section-by-Section Analysis of Part 63

Subpart A--General Provisions

    This subpart, except for Sec. 63.2, ``Definitions,'' contains 
proposed general provisions that are similar to the provisions of Part 
60 with minor wording changes for simplification, clarification, or to 
refer specifically to the Yucca Mountain site, where appropriate. 
Definitions have been revised to reflect usage in this part, as 
appropriate.
    Section 63.1 Purpose and scope. This section defines the purpose 
and scope of Part 63 to be limited to the licensing of DOE to receive 
and possess source, special nuclear, and byproduct material at a 
geologic repository operations area sited, constructed, or operated at 
Yucca Mountain, Nevada. It states that generic regulations at Part 60 
of this title do not apply, and cannot be the subject of any litigation 
in any licensing proceeding for the Yucca Mountain site.
    Section 63.2 Definitions. This section contains definitions of 
terms as used in this part.
    Section 63.3 License required. This section prohibits DOE from 
receiving or possessing source, special nuclear, or byproduct material 
at a geologic repository operations area at the Yucca Mountain site 
without having a license issued by the Commission, and prohibits DOE 
from beginning construction of the geologic repository operations area 
without authorization from the Commission.
    Section 63.4 Communications and records. This section describes 
requirements for communications and reports submitted to the 
Commission, including appropriate addresses for communications to be 
forwarded to NRC.
    Section 63.5 Interpretations. This section specifies when 
interpretations of the meaning of the regulations in this part by NRC 
officers or employees will be considered binding on the Commission.
    Section 63.6 Exemptions. This section states the bases on which the 
Commission may grant exemptions from the requirements of this part.
    Section 63.7 License not required for certain preliminary 
activities. This section allows DOE to possess source, special nuclear, 
or byproduct material at Yucca Mountain for the purposes of site 
characterization, and for use in certain construction activities.
    Section 63.8 Information collection requirements: Approval. This 
section indicates that the information collection requirements 
contained in this part have been reviewed and approved by the Office of 
Management and Budget in accordance with the Paperwork Reduction Act.
    Section 63.9 Employee protection. This section specifies 
requirements for protection of licensee or contractor and subcontractor 
personnel from certain adverse actions by employers.
    Section 63.10 Completeness and accuracy of information. This 
section requires information provided to the Commission be complete and 
accurate. It also requires NRC notification of information having 
significant public health and safety implications.
    Section 63.11 Deliberate misconduct. This section prohibits certain 
licensee activities and describes resulting enforcement action.

Subpart B--Licenses

    This subpart, except for Sec. 63.15, ``Site characterization,'' 
Sec. 63.16, ``Review of site characterization activities,'' and 
Sec. 63.21, ``Content of application,'' contains proposed provisions 
that are similar to the licensing provisions of Part 60 with minor 
wording changes for simplification, clarification or to refer to the 
Yucca Mountain site, where appropriate. Provisions related to the 
content of the license application have been developed to be consistent 
with the proposed technical criteria of Subpart E. Provisions related 
to site characterization have been simplified from similar sections of 
Part 60 to reflect the maturity of site characterization at Yucca 
Mountain. For example, there are no provisions requiring DOE to prepare 
and submit a site characterization plan to NRC or any requirement for 
NRC to prepare a specific site characterization analysis in as much as 
both activities have been completed previously. However, provisions 
requiring DOE to undertake site characterization and submit semiannual 
progress reports to NRC and provisions allowing NRC to comment on any 
aspect of site characterization or performance assessment, at any time, 
are proposed as indicated in the analysis of pertinent sections of 
Subpart B that follows.
    Section 63.15 Site characterization. This section specifies that a 
program of site characterization is to be conducted prior to submittal 
of an application and that investigations are to be conducted in a 
manner that limits adverse effects on the performance of the geologic 
repository.
    Section 63.16 Review of site characterization activities. This 
section specifies that DOE must submit to the Commission semiannual 
reports on the progress of site characterization, that NRC staff shall 
be permitted to visit, inspect, and observe site characterization 
activities at the Yucca Mountain site, and that the Director may at any 
time comment on any aspect of site characterization and performance 
assessment. This section also specifies that the Commission will 
determine whether any proposed onsite testing with radioactive material 
during site characterization is necessary to provide data for the 
preparation of the environmental reports required by law and for the 
license application.
    Section 63.21 Content of application. This section specifies that 
the license application must include general information, a safety 
analysis report, and be accompanied by an environmental impact 
statement. This section also describes the detailed information to be 
included in the safety analysis report.
    Section 63.22 Filing and distribution of application. This section 
describes requirements for filing and distribution of the license 
application, amendments to the license application, environmental 
reports, and related updates and supplements.
    Section 63.23 Elimination of repetition. This section allows DOE to 
incorporate by reference information in previous applications, 
statements, or reports filed with the Commission in its application or 
environmental statement.
    Section 63.24 Updating of application and environmental impact 
statement. This section requires DOE to submit a complete application, 
to update or supplement the application or environmental impact 
statement in a

[[Page 8656]]

timely manner, and certify that updated copies contain current 
information.
    Section 63.31 Construction authorization. This section states the 
bases on which the Commission may authorize construction of a geologic 
repository operations area at the Yucca Mountain site.
    Section 63.32 Conditions of construction authorization. This 
section indicates that the Commission will include conditions in the 
construction authorization as necessary to protect the health and 
safety of the public, the common defense and security, and 
environmental values and describes specific provisions and restrictions 
that will be included in the construction authorization. This section 
also indicates that a license will not be issued until DOE has updated 
its application as required at Sec. 63.24 and the Commission has made 
the findings stated at Sec. 63.41.
    Section 63.33 Amendment of construction authorization. This section 
requires DOE to apply for an amendment of the construction 
authorization if changes are desired. This section also states the 
bases on which the Commission may approve an amendment of the 
construction authorization.
    Section 63.41 Standards for issuance of a license. This section 
states the bases on which the Commission may issue a license to receive 
and possess source, special nuclear, or byproduct material at a 
geologic repository operations area at the Yucca Mountain site.
    Section 63.42 Conditions of license. This section indicates that 
the Commission will include conditions or specifications in the license 
as necessary to protect the health and safety of the public, the common 
defense and security, and environmental values. This section also 
identifies general conditions that will be considered conditions of the 
license, whether stated in the license or not.
    Section 63.43 License specification. This section indicates that 
the Commission will include conditions in the license that are derived 
from the analyses and evaluations included in the application and 
amendments made before a license is issued. This section also describes 
specific categories of restrictions, requirements, and controls that 
will be included as conditions of the license.
    Section 63.44 Changes, tests, and experiments. This section states 
the bases on which DOE may change the geologic repository operations 
area or procedures as described in the application, and conduct tests 
or experiments not described in the application, without prior 
Commission approval. This section also requires DOE to maintain records 
of changes made and tests undertaken pursuant to this section.
    Section 63.45 Amendment of license. This section requires DOE to 
apply for an amendment of the license if changes are desired. This 
section also states the bases on which the Commission may approve an 
amendment of the license.
    Section 63.46 Particular activities requiring license amendment. 
This section describes specific activities that require amending the 
license prior to being performed, unless expressly authorized in the 
license.
    Section 63.51 License amendment for permanent closure. This section 
requires DOE to apply for an amendment of the license to permanently 
close a geologic repository at the Yucca Mountain site. This section 
also requires DOE to submit an update of the license application and 
describes the detailed information to be included in the update.
    Section 63.52 License termination. This section requires DOE to 
apply for an amendment to terminate the license following permanent 
closure of the geologic repository and the decontamination or 
dismantlement of surface facilities at the Yucca Mountain site.

Subpart C--Participation by State Government and Affected Indian Tribes

    This subpart contains proposed provisions that are similar to the 
State and affected Indian Tribe participation provisions of 10 CFR Part 
60 with minor wording changes to refer to the State of Nevada and Yucca 
Mountain site, where appropriate.
    Section 63.61 Provision of information. This section states that 
NRC shall provide to the Governor, the Nevada State legislature, and 
any affected Indian Tribe timely and complete information regarding 
determinations made by the Commission with respect to the Yucca 
Mountain site. NRC shall also make this information available to the 
public and DOE.
    Section 63.62 Site review. This section states that NRC shall 
consult with the State of Nevada and affected Indian Tribes regarding 
site characterization activities.
    Section 63.63 Participation in license reviews. This section sets 
forth procedures for State and local governments and affected Indian 
Tribes to participate in license review activities.
    Section 63.64 Notice to state. This section notes that, if the 
Governor and legislature of the State of Nevada have designated a joint 
person or entity to receive information from NRC, NRC will send such 
information to the jointly designated addressee.
    Section 63.65 Representation. This section allows the Commission to 
request that any person acting as a representative of the State, 
Governor, or legislature of Nevada, or any affected Indian Tribe 
provide the Commission with the authority basis for such a 
representation.

Subpart D--Records, Reports, Tests, and Inspections

    This subpart contains proposed provisions that are similar to the 
records, reports, tests, and inspection provisions of Part 60 with 
minor wording changes for simplification, clarification or to refer to 
the Yucca Mountain site, as appropriate.
    Section 63.71 Records and reports. This section requires DOE to 
make and maintain records and reports as required by conditions of the 
license or rules, regulations, and orders of the Commission.
    Section 63.72 Construction records. This section requires DOE to 
maintain records of the construction of the geologic repository 
operations area and describes the types of records to be maintained.
    Section 63.73 Reports of deficiencies. This section requires DOE to 
notify the Commission of each deficiency found in the characteristics 
of the Yucca Mountain site and design and construction of the geologic 
repository operations area, if the uncorrected deficiency could be a 
safety hazard, represent a deviation from the design criteria or design 
bases, or represent a deviation from conditions of the construction 
authorization or license.
    Section 63.74 Tests. This section requires DOE to perform such 
tests, or to allow the Commission to perform such tests, as the 
Commission determines necessary for administration of the regulations 
in this part. This section also describes the types of tests that may 
be included under this section.
    Section 63.75 Inspections. This section requires DOE to afford the 
Commission opportunity for inspection of the geologic repository 
operations area and adjacent areas. This section also requires DOE to 
provide office space for Commission inspection personnel.
    Section 63.78 Material control and accounting records and reports. 
This section requires DOE to establish a material inventory system, 
whereby material and accounting procedures are developed, physical 
inventories are

[[Page 8657]]

performed, loss of special nuclear material, or accidental criticality 
is reported, and material status and nuclear material transfer reports 
are generated. This section notes that the material and accounting 
program is to be the same as that specified at Secs. 72.72, 72.74, 
72.76, and 72.78.

Subpart E--Technical Criteria

    This subpart, except for Sec. 63.101, ``Purpose and nature of 
findings,'' Sec. 63.102, ``Concepts,'' and Sec. 63.121, ``Requirements 
for ownership and control of interests in land,'' contains proposed 
performance objectives for the geologic repository area through 
permanent closure (preclosure) and the geologic repository after 
permanent closure (postclosure), and requirements for the analyses used 
to demonstrate compliance with the performance objectives. The 
preclosure performance objective is similar to the provisions in Part 
60. However, the postclosure performance objective and other 
requirements differ significantly from Part 60. This subpart proposes 
compliance to be demonstrated in the context of safety analyses of 
total system performance and does not prescribe general design or 
siting criteria, or specific quantitative subsystem performance 
objectives as was done in Part 60. The Commission is proposing an 
individual dose limit that is believed to be generally consistent with 
the Energy Policy Act of 1992 and the findings and recommendations of 
the National Academy of Sciences' technical bases for Yucca Mountain 
Standards. When final EPA standards for Yucca Mountain are published, 
the Commission will amend its regulations to be consistent with the 
standards, if necessary.
    Section 63.101 Purpose and nature of findings. This section 
describes the Commission's expectations for demonstration that the 
geologic repository will be in conformance with the performance 
objectives.
    Section 63.102 Concepts. This section provides a functional 
overview of this subpart.
    Section 63.111 Performance objectives for the geologic repository 
operations area through permanent closure. This section requires DOE to 
design the geologic operations area to comply with the exposure limits 
given in this section, conduct an integrated safety analysis, permit 
implementation of a performance confirmation program, and preserve the 
option for waste retrieval.
    Section 63.112 Requirements for integrated safety analysis of the 
geologic repository operations area. This section specifies the 
requirements for the integrated safety analysis used to demonstrate 
compliance with the performance objective through permanent closure 
provided at Secs. 63.111(a)(1) and 63.111(a)(2).
    Section 63.113 Performance objective for the geologic repository 
after permanent closure. This section requires DOE to include a system 
of multiple barriers for the geologic repository, comply with the 
individual annual dose limit, conduct a performance assessment, and 
assess the consequences of a specified human intrusion event.
    Section 63.114 Requirements for performance assessment. This 
section specifies the requirements for the performance assessment used 
to demonstrate compliance with the individual dose limit specified at 
Sec. 63.113(b).
    Section 63.115 Required characteristics of the reference biosphere 
and critical group. This section specifies characteristics of the 
reference biosphere and critical group to be used by DOE in their 
performance assessment.
    Section 63.121 Requirements for ownership and control of interests 
in land. This section requires DOE to have permanent control of the 
site. It states that DOE shall set up controls necessary to prevent 
adverse human actions that could affect the repository. DOE is required 
to obtain water rights needed for the repository.

Subpart F--Performance Confirmation Program

    This subpart contains proposed provisions that are similar to the 
performance confirmation provisions of 10 CFR Part 60.
    Section 63.131 General requirements. This section states the 
objectives of the performance confirmation program and specifies that 
the program be started during site characterization and continue until 
permanent closure.
    Section 63.132 Confirmation of geotechnical and design parameters. 
This section requires DOE to monitor subsurface conditions during 
repository construction and operation to confirm original design 
assumptions and to ensure that performance of geologic and engineered 
features is within design limits. DOE is also required to inform the 
Commission of any design changes needed to accommodate actual field 
conditions encountered.
    Section 63.133 Design testing. This section requires DOE to 
undertake a program of in situ testing of such features as borehole and 
shaft seals, backfill, and the thermal interaction effects of waste 
packages, backfill, rock, and groundwater.
    Section 63.134 Monitoring and testing waste packages. This section 
requires DOE to establish a program for monitoring and testing waste 
packages at the geologic repository operations area that is to continue 
as long as practical up to the time of permanent closure.

Subpart G--Quality Assurance

    This subpart contains proposed provisions that are similar to the 
quality assurance provisions of 10 CFR Part 60.
    Section 63.141 Scope. This section requires DOE to establish a 
quality assurance program to be applied at the geologic repository at 
the Yucca Mountain site.
    Section 63.142 Applicability. This section indicates that the 
quality assurance program applies to all systems, structures, and 
components important to safety, to design and characterization of 
barriers important to waste isolation, and to activities related 
thereto.
    Section 63.143 Implementation. This section indicates that the 
quality assurance program is to be based on the criteria of Appendix B 
of 10 CFR Part 50, as applicable and appropriately supplemented as 
required by Sec. 63.142.

Subpart H--Training and Certification of Personnel

    This subpart contains proposed provisions that are similar to the 
training and certification provisions of 10 CFR Part 60.
    Section 63.151 General requirements. This section specifies that 
operations of systems and components important to safety are to be 
performed only by trained and certified personnel or by personnel under 
the direct visual supervision of an individual with training and 
certification in such operations. This section also specifies that 
supervisory personnel who direct operations that are important to 
safety are to be certified in such operations.
    Section 63.152 Training and certification program. This section 
specifies that a program for training, proficiency testing, 
certification, and requalification of operating and supervisory 
personnel is to be established.
    Section 63.153 Physical requirements. This section specifies 
physical requirements for personnel certified for operations that are 
important to safety.

Subpart I--Emergency Planning Criteria

    This subpart contains proposed provisions for emergency planning.

[[Page 8658]]

    Section 63.161 Emergency plan for the geologic repository 
operations area through permanent closure. This section requires DOE to 
develop and be prepared to implement a plan to cope with radiological 
emergencies. The section indicates that the emergency plan is to be 
based on criteria at Sec. 72.32(b).

Subpart J--Violations

    This subpart contains proposed provisions that are similar to the 
violation provisions of 10 CFR Part 60.
    Section 63.171 Violations. This section specifies actions the 
Commission may take, including obtaining a court order to prevent a 
violation, and contains civil penalty provisions.
    Section 63.172 Criminal penalties. This section specifies criminal 
sanctions for violations. For purposes of Section 223 of the Atomic 
Energy Act of 1954, as amended, that provides for criminal sanctions, 
all regulations in Part 63 are issued under one or more of Secs. 161b, 
161i, or 161o except for the sections listed in Sec. 63.172(b).

XIX. Section-by-Section Analysis of Changes to Other Parts

    Section-by-section analysis of changes to Parts 2,19, 20, 21, 30, 
40, 51, and 61.

10 CFR Part 2

    Section 2.101 Filing of applications is amended to add reference to 
Part 63 in the procedures for filing of applications.
    Section 2.103 Action on applications for byproduct, source, special 
nuclear material, and operator licenses is amended to add reference to 
Part 63 in the procedures for notification in this section.
    Section 2.104 Notice of hearing is amended to add reference to Part 
63 in the procedures for notification of hearings.
    Section 2.105 Notice of proposed action is amended to add reference 
to Part 63 in the procedures for notification of proposed actions in 
this section.
    Section 2.106(c) Notice of issuance is amended to provide for 
public notification of any action with respect to a license application 
or license amendment pursuant to Part 63.

10 CFR Part 19

    Section 19.2 Scope is amended to make Part 63 subject to the 
regulations in Part 19.
    Section 19.3 Definitions is amended to add Part 63 to the 
definition of ``license.''

10 CFR Part 20

    Section 20.1002 Scope is amended to make Part 63 subject to the 
regulations in Part 20.

10 CFR Part 21

    Section 21.2(a) Scope is amended to make Part 63 subject to the 
regulations in Part 21.
    Certain definitions in Sec. 21.3 Definitions are amended to include 
Part 63.
    By changes to Sec. 21.21 Notification of failure to comply or of a 
defect and its evaluation, Part 63 is made subject to the regulations 
for reporting defects and noncompliance.

10 CFR Part 30

    Changes to Sec. 30.11 Specific exemptions make DOE exempt from Part 
30 regulations for activities subject to Part 63.

10 CFR Part 40

    Changes to Sec. 40.14 Specific exemptions make DOE exempt from Part 
40 regulations for activities subject to Part 63.

10 CFR Part 51

    Section 51.20 Criteria for and identification of licensing and 
regulatory actions requiring environmental impact statements is amended 
to add reference to Part 63 under actions requiring environmental 
impact statements.
    Section 51.22 Criteria for categorical exclusion; identification of 
licensing and regulatory actions eligible for categorical exclusion or 
otherwise not requiring environmental review is amended to add 
reference to Part 63 in requirements for categorical exclusion from 
environmental review.
    Section 51.26 Requirement to publish notice of intent and conduct 
scoping process is amended to add reference to Part 63 in procedures 
for receipt of an application and accompanying environmental impact 
statement from DOE.
    Section 51.67 Environmental information concerning geologic 
repositories is amended to add reference to Part 63 in requirements for 
submission of an environmental impact statement by DOE.

10 CFR Part 61

    Section 61.1 Purpose and scope is amended to state that the 
regulations of Part 61 do not apply to disposal of HLW as provided for 
in Part 63.
    Section 61.2 Definitions, the definition of ``land disposal 
facility'' is amended to clarify that a geologic repository as defined 
in Part 63 is not considered a land disposal facility.
    Section 61.55 Waste classification is amended to add reference to 
Part 63 in the definition of a geologic repository.

XX. Specific Questions for Public Comment

    The Commission welcomes comments on all aspects of this proposed 
rule, and is especially interested in receiving comments on the 
following:
    1. The Commission solicits comments on the appropriateness of its 
proposed approach to defining the critical group and reference 
biosphere for Yucca Mountain. In particular, the Commission solicits 
comments on any other candidate population groups, biosphere 
assumptions and potential exposure pathways that should be considered 
in the establishment of a ``critical group'' for Yucca Mountain.
    2. The Commission solicits comments on the appropriateness of its 
proposed human intrusion scenario, and the assumed timing of its 
occurrence, as a reasonable measure for evaluating the consequences of 
intrusion at a repository at Yucca Mountain.
    3. The Commission solicits comment on the merits of requiring DOE 
to implement a quality assurance program for the geologic repository 
based on the criteria of Appendix B of 10 CFR Part 50.
    4. The Commission solicits comments on the suitability of 
alternative criteria for proposed Sec. 63.44. These alternative 
criteria are included in the statement of considerations discussion of 
proposed Sec. 63.44 and are substantially equivalent to that proposed 
last year for nuclear reactors and spent fuel storage facilities.
    5. The Commission solicits comments on whether the approach and 
criteria for changes, tests, and experiments at Sec. 63.44 should apply 
solely to the Safety Analysis Report or to the contents of the entire 
license application, irrespective of whether proposed Sec. 63.44 or the 
alternative criteria presented in the statement of consideration are 
selected.

XXI. Plain Language

    The Presidential memorandum dated June 1, 1998, entitled ``Plain 
Language in Government Writing,'' directed that the Federal 
government's writing be in plain language. The NRC requests comments on 
this proposed rule specifically with respect to the clarity and 
effectiveness of the language used. Comments should be sent to the 
address listed above.

[[Page 8659]]

XXII. Finding of No Significant Environmental Impact: Availability

    Pursuant to Section 121(c) of the Nuclear Waste Policy Act, this 
proposed rule does not require the preparation of an environmental 
impact statement under Section 102(2)(c) of the National Environmental 
Policy Act of 1969 or any environmental review under subparagraph (E) 
or (F) of Section 102(2) of such act.

XXIII. Paperwork Reduction Act Statement

    This proposed rule contains information collection requirements 
that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.). This rule has been submitted to the Office of Management and 
Budget for review and approval of the paperwork requirements.
    The public reporting burden for this collection of information is 
estimated to average 121 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information. The U.S. Nuclear Regulatory Commission is 
seeking public comment on the potential impact of the information 
collection contained in the proposed rule and on the following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of NRC, including whether the information 
will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    Send comments on any aspect of this proposed information 
collection, including suggestions for reducing this burden, to the 
Records Management Branch (T-6F-33), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by Internet electronic mail 
at 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 
(d)(1)(ii) to read as follows:


Sec. 21.21  Notification of failure to comply or existence of a defect 
and its evaluation.

* * * * *
    (d)(1) * * *
    (i) The construction or operation of a facility or an activity 
within the United States that is subject to the licensing requirements 
under Parts 30, 40, 50, 60, 61, 63, 70, or 72 of this chapter and that 
is within his or her organization's responsibility; or
    (ii) A basic component that is within his or her organization's 
responsibility and is supplied for a facility or an activity within the 
United States that is subject to the licensing requirements under Parts 
30, 40, 50, 60, 61, 63, 70, or 72 of this chapter.
* * * * *

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

    16. The authority citation for Part 30 continues to read as 
follows:

    Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 
953, 954, 955, as amended, sec. 234, 83 Stat. 444 as amended (42 
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246(42 U.S.C. 
5841, 5842, 5846).


[[Page 8662]]


    Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 (42 U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 69 
Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
    17. Section 30.11 is amended by revising paragraph (c) to read as 
follows:


Sec. 30.11  Specific exemptions.

* * * * *
    (c) The DOE is exempt from the requirements of this part to the 
extent that its activities are subject to the requirements of Parts 60 
or 63 of this chapter.
* * * * *

PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL

    18. The authority citation for Part 40 continues to read as 
follows:

    Authority: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 
Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2), 
83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 
83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 
2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274, 
Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L. 
97-415, 96 Stat. 2067 (42 U.S.C. 2022).

    Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 (42 U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68 
Stat. 939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 
68 Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued 
under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
    19. Section 40.14 is amended by revising paragraph (c) to read as 
follows:


Sec. 40.14  Specific exemptions.

* * * * *
    (c) The DOE is exempt from the requirements of this part to the 
extent that its activities are subject to the requirements of Parts 60 
or 63 of this chapter.
* * * * *

PART 51--ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC 
LICENSING AND RELATED REGULATORY FUNCTIONS

    20. The authority citation for Part 51 continues to read as 
follows:

    Authority: Sec. 161, 68 Stat. 948, as amended, sec. 1701, 106 
Stat. 2951, 2952, 2953, (42 U.S.C. 2201, 2297f); secs. 201, as 
amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 
5842). Subpart A also issued under National Environmental Policy Act 
of 1969, secs. 102, 104, 105, 83 Stat. 853-854, as amended (42 
U.S.C. 4332, 4334, 4335); and Pub. L. 95-604, Title II, 92 Stat. 
3033-3041; and sec. 193, Pub. L. 101-575, 104 Stat. 2835 (42 U.S.C. 
2243). Sections 51.20, 51.30 51.60, 51.61, 51.80, and 51.97 also 
issued under secs 135, 141, Pub. L. 97-425, 96 Stat, 2232, 2241, and 
sec. 148, Pub. L. 100-203, 101 Stat. 1330-223 (42 U.S.C. 10155, 
10161, 10168). Section 51.22 also issued under sec. 274, 73 Stat. 
688, as amended by 92 Stat. 3036-3038 (42 U.S.C. 2021 and under 
Nuclear Waste Policy Act of 1982, sec. 121, 96 Stat. 2228 (42 U.S.C. 
10141). Sections 51.43, 51.67, and 51.109 also issued under Nuclear 
Waste Policy Act of 1982, sec 114(f), 96 Stat, 2216, as amended (42 
U.S.C. 10134 (f)).

    21. Section 51.20 is amended by revising paragraph (b)(13) to read 
as follows:


Sec. 51.20  Criteria for and identification of licensing and regulatory 
actions requiring environmental impact statements.

* * * * *
    (b) * * *
    (13) Issuance of a construction authorization and license pursuant 
to Parts 60 or 63 of this chapter.
* * * * *
    22. Section 51.22 is amended by revising paragraphs (c)(3), 
(c)(10), and (d) to read as follows:


Sec. 51.22  Criteria for categorical exclusion; identification of 
licensing and regulatory actions eligible for categorical exclusion or 
otherwise not requiring environmental review.

* * * * *
    (c) * * *
    (3) Amendments to Parts 20, 30, 31, 32, 33, 34, 35, 39, 40, 50, 51, 
54, 60, 61, 63, 70, 71, 72, 73, 74, 81, and 100 of this chapter which 
relate to--
* * * * *
    (10) Issuance of an amendment to a permit or license pursuant to 
Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, 50, 60, 61, 63, 70, or Part 
72 of this chapter which--
    (i) Changes surety, insurance and/or indemnity requirements; or
    (ii) Changes recordkeeping, reporting, or administrative procedures 
or requirements.
* * * * *
    (d) In accordance with Section 121 of the Nuclear Waste Policy Act 
of 1982 (42 U.S.C. 10141), the promulgation of technical requirements 
and criteria that the Commission will apply in approving or 
disapproving applications under Parts 60 or 63 of this chapter shall 
not require an environmental impact statement, an environmental 
assessment, or any environmental review under subparagraph (E) or (F) 
of section 102(2) of NEPA.
    23. Section 51.26 is amended by revising paragraph (c) to read as 
follows:


Sec. 51.26  Requirement to publish notice of intent and conduct scoping 
process.

* * * * *
    (c) Upon receipt of an application and accompanying environmental 
impact statement under Sec. 60.22 or Sec. 63.22 of this chapter 
(pertaining to geologic repositories for high-level radioactive waste), 
the appropriate NRC staff director will include in the notice of 
docketing required to be published by Sec. 2.101(f)(8) of this chapter 
a statement of Commission intention to adopt the environmental impact 
statement to the extent practicable. However, if the appropriate NRC 
staff director determines, at the time of such publication or at any 
time thereafter, that NRC should prepare a supplemental environmental 
impact statement in connection with the Commission's action on the 
license application, the procedures set out in paragraph (a) of this 
section shall be followed.
    24. Section 51.67 is amended by revising paragraphs (a) and (b) to 
read as follows:


Sec. 51.67  Environmental information concerning geologic repositories.

    (a) In lieu of an environmental report, the Department of Energy, 
as an applicant for a license or license amendment pursuant to Parts 60 
or 63 of this chapter, shall submit to the Commission any final 
environmental impact statement which the department prepares in 
connection with any geologic repository developed under Subtitle A of 
Title I, or under Title IV, of the Nuclear Waste Policy Act of 1982, as 
amended. (See Sec. 60.22 or Sec. 63.22 of this chapter as to required 
time and manner of submission.) The statement shall include, among the 
alternatives under consideration, denial of a license or construction 
authorization by the Commission.
    (b) Under applicable provisions of law, the Department of Energy 
may be required to supplement its final environmental impact statement 
if it makes a substantial change in its proposed action that is 
relevant to environmental concerns or determines that there are 
significant new circumstances or information relevant to environmental 
concerns and bearing on the proposed action or its impacts. The 
Department shall submit any supplement to its final environmental 
impact statement to the Commission. (See Sec. 60.22 or Sec. 63.22 of 
this chapter as

[[Page 8663]]

to required time and manner of submission.)
* * * * *

PART 60--DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC 
REPOSITORIES

    25. The authority citation for Part 60 continues to read as 
follows:

    Authority: Secs. 51, 53, 62, 63, 65, 81, 161, 182, 183, 68 Stat. 
929, 930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2071, 
2073, 2092, 2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88 
Stat.1244, 1246 (42 U.S.C. 5842, 5846); secs. 10 and 14, Pub. L. 95-
601, 92 Stat. 2951 (42 U.S.C. 2021a and 5851); sec. 102, Pub. L. 91-
190, 83 Stat. 853 (42 U.S.C. 4332); secs. 114, 121, Pub. L. 97-425, 
96 Stat. 2213g, 2238, as amended (42 U.S.C. 10134, 10141), and Pub. 
L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851).

    26. Section 60.1 is revised to read as follows:


Sec. 60.1  Purpose and scope.

    This part prescribes rules governing the licensing of the U.S. 
Department of Energy to receive and possess source, special nuclear, 
and byproduct material at a geologic repository operations area sited, 
constructed, or operated in accordance with the Nuclear Waste Policy 
Act of 1982. This part does not apply to any activity licensed under 
another part of this chapter. This part does not apply to the licensing 
of the U.S. Department of Energy to receive and possess source, special 
nuclear, and byproduct material at a geologic repository operations 
area sited, constructed, or operated at Yucca Mountain, Nevada, in 
accordance with the Nuclear Waste Policy Act of 1982, as amended, and 
the Energy Policy Act of 1992, subject to Part 63 of this chapter. This 
part also gives notice to all persons who knowingly provide to any 
licensee, applicant, contractor, or subcontractor, components, 
equipment, materials, or other goods or services, that relate to a 
licensee's or applicant's activities subject to this part, that they 
may be individually subject to NRC enforcement action for violation of 
Sec. 60.11.

PART 61--LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE 
WASTE

    27. The authority citation for Part 61 continues to read as 
follows:

    Authority: Secs. 53, 57, 62, 63, 65, 81, 161, 182, 183, 68 Stat. 
930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2073, 2077, 
2092, 2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88 Stat. 
1244, 1246, (42 U.S.C. 5842, 5846); secs. 10 and 14, Pub. L. 95-601, 
92 Stat. 2951 (42 U.S.C. 2021a and 5851) and Pub. L. 102-486, sec. 
2902, 106 Stat. 3123, (42 U.S.C. 5851).

    28. Section 61.1 is amended by revising paragraph (b) to read as 
follows:


Sec. 61.1  Purpose and scope.

* * * * *
    (b) Except as provided in Part 150 of this chapter, which addresses 
assumption of certain regulatory authority by Agreement States, and 
Sec. 61.6 ``Exemptions,'' the regulations in this part apply to all 
persons in the United States. The regulations in this part do not apply 
to--
    (1) Disposal of high-level waste as provided for in Parts 60 or 63 
of this chapter;
    (2) Disposal of uranium or thorium tailings or wastes (byproduct 
material as defined in Sec. 40.4 (a-1) as provided for in Part 40 of 
this chapter in quantities greater than 10,000 kilograms and containing 
more than 5 millicuries of radium-226; or
    (3) Disposal of licensed material as provided for in Part 20 of 
this chapter.
* * * * *
    29. In Section 61.2, the definition of Land disposal facility is 
revised to read as follows:


Sec. 61.2  Definitions.

* * * * *
    Land disposal facility means the land, building, and structures, 
and equipment which are intended to be used for the disposal of 
radioactive wastes. For purposes of this chapter, a ``geologic 
repository'' as defined in Parts 60 or 63 is not considered a land 
disposal facility.
* * * * *
    30. Section 61.55 is amended by revising paragraph (a)(2)(iv) to 
read as follows:


Sec. 61.55  Waste classification.

    (a) * * *
    (2) * * *
    (iv) Waste that is not generally acceptable for near-surface 
disposal is waste for which form and disposal methods must be 
different, and in general more stringent, than those specified for 
Class C waste. In the absence of specific requirements in this part, 
such waste must be disposed of in a geologic repository as defined in 
Parts 60 or 63 of this chapter unless proposals for disposal of such 
waste in a disposal site licensed pursuant to this part are approved by 
the Commission.
* * * * *
    31. Part 63 is added to read as follows:

PART 63--DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC 
REPOSITORY AT YUCCA MOUNTAIN, NEVADA

Subpart A--General Provisions

Sec.
63.1  Purpose and scope.
63.2  Definitions.
63.3  License required.
63.4  Communications and records.
63.5  Interpretations.
63.6  Exemptions.
63.7  License not required for certain preliminary activities.
63.8  Information collection requirements: OMB Approval.
63.9  Employee protection.
63.10  Completeness and accuracy of information.
63.11  Deliberate misconduct.

Subpart B--Licenses

PREAPPLICATION REVIEW

63.15  Site characterization.
63.16  Review of site characterization activities.

LICENSE APPLICATION

63.21  Content of application.
63.22  Filing and distribution of application.
63.23  Elimination of repetition.
63.24  Updating of application and environmental impact statement.

CONSTRUCTION AUTHORIZATION

63.31  Construction authorization.
63.32  Conditions of construction authorization.
63.33  Amendment of construction authorization.

LICENSE ISSUANCE AND AMENDMENT

63.41  Standards for issuance of a license.
63.42  Conditions of license.
63.43  License specification.
63.44  Changes, tests, and experiments.
63.45  Amendment of license.
63.46  Particular activities requiring license amendment.

PERMANENT CLOSURE

63.51  License amendment for permanent closure.
63.52  Termination of license.

Subpart C--Participation by State Government and Affected Indian Tribes

63.61  Provision of information.
63.62  Site review.
63.63  Participation in license reviews.
63.64  Notice to State.
63.65  Representation.

Subpart D--Records, Reports, Tests, and Inspections

63.71  Records and reports.
63.72  Construction records.
63.73  Reports of deficiencies.
63.74  Tests.
63.75  Inspections.
63.78  Material control and accounting records and reports.

[[Page 8664]]

Subpart E--Technical Criteria

63.101  Purpose and nature of findings.
63.102  Concepts.

PERFORMANCE OBJECTIVES

63.111  Performance objectives for the geologic repository 
operations area through permanent closure.

INTEGRATED SAFETY ANALYSIS

63.112  Requirements for integrated safety analysis of the geologic 
repository operations area.
63.113  Performance objective for the geologic repository after 
permanent closure.

PERFORMANCE ASSESSMENT

63.114  Requirements for performance assessment.

CHARACTERISTICS OF THE REFERENCE BIOSPHERE AND CRITICAL GROUP

63.115  Required characteristics of the reference biosphere and 
critical group.

LAND OWNERSHIP AND CONTROL

63.121  Requirements for ownership and control of interests in land.

Subpart F--Performance Confirmation Program

63.131  General requirements.
63.132  Confirmation of geotechnical and design parameters.
63.133  Design testing.
63.134  Monitoring and testing waste packages.

Subpart G--Quality Assurance

63.141  Scope.
63.142  Applicability.
63.143  Implementation.

Subpart H--Training and Certification of Personnel

63.151  General requirements.
63.152  Training and certification program.
63.153  Physical requirements.

Subpart I--Emergency Planning Criteria

63.161  Emergency plan for the geologic repository operations area 
through permanent closure.

Subpart J--Violations

63.171  Violations.
63.172  Criminal penalties.

    Authority: Secs. 51, 53, 62, 63, 65, 81, 161, 182, 183, 68 Stat. 
929, 930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2071, 
2073, 2092, 2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88 
Stat.1244, 1246 (42 U.S.C. 5842, 5846); secs. 10 and 14, Pub. L. 95-
601, 92 Stat. 2951 (42 U.S.C. 2021a and 5851); sec. 102, Pub. L. 91-
190, 83 Stat. 853 (42 U.S.C. 4332); secs. 114, 121, Pub. L. 97-425, 
96 Stat. 2213g, 2238, as amended (42 U.S.C. 10134, 10141), and Pub. 
L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851).

Subpart A--General Provisions


Sec. 63.1  Purpose and scope.

    This part prescribes rules governing the licensing of the U.S. 
Department of Energy to receive and possess source, special nuclear, 
and byproduct material at a geologic repository operations area sited, 
constructed, or operated at Yucca Mountain, Nevada, in accordance with 
the Nuclear Waste Policy Act of 1982, as amended, and the Energy Policy 
Act of 1992. As provided in Sec. 60.1, ``Purpose and scope,'' the 
regulations in Part 60 of this chapter do not apply to any activity 
that is subject to licensing under this part. This part does not apply 
to any activity licensed under another part of this chapter. This part 
also gives notice to all persons who knowingly provide, to any 
licensee, applicant, contractor, or subcontractor, components, 
equipment, materials, or other goods or services, that relate to a 
licensee's or applicant's activities subject to this part, that they 
may be individually subject to NRC enforcement action for violation of 
Sec. 63.11.


Sec. 63.2  Definitions.

    As used in this part:
    Affected Indian Tribe means any Indian Tribe within whose 
reservation boundaries a repository for high-level radioactive waste or 
spent fuel is proposed to be located; or whose Federally defined 
possessory or usage rights to other lands outside of the reservation's 
boundaries arising out of Congressionally ratified treaties or other 
Federal law may be substantially and adversely affected by the locating 
of such a facility; Provided, that the Secretary of the Interior finds, 
on the petition of the appropriate governmental officials of the Tribe, 
that such effects are both substantial and adverse to the Tribe.
    Annual dose means the total effective dose equivalent (TEDE as 
defined at Sec. 20.1003) received in a single year by the average 
member of the critical group only as a result of radioactive materials 
released from the geologic repository.
    Barrier means any material or structure that prevents or 
substantially delays movement of water or radioactive materials.
    Commencement of construction means clearing of land, surface or 
subsurface excavation, or other substantial action that would adversely 
affect the environment of a site. It does not include changes desirable 
for the temporary use of the land for public recreational uses, site 
characterization activities, other preconstruction monitoring and 
investigation necessary to establish background information related to 
the suitability of the Yucca Mountain site or to the protection of 
environmental values, or procurement or manufacture of components of 
the geologic repository operations area.
    Commission means the Nuclear Regulatory Commission or its duly 
authorized representatives.
    Containment means the confinement of radioactive waste within a 
designated boundary.
    Critical group means the hypothetical group of individuals 
reasonably expected to receive the greatest exposure to radioactive 
materials released from the geologic repository.
    Design bases means that information that identifies the specific 
functions to be performed by a structure, system, or component of a 
facility and the specific values or ranges of values chosen for 
controlling parameters as reference bounds for design. These values may 
be restraints derived from generally accepted ``state-of-the-art'' 
practices for achieving functional goals or requirements derived from 
analysis (based on calculation or experiments) of the effects of a 
postulated event under which a structure, system, or component must 
meet its functional goals. The values for controlling parameters for 
external events include:
    (1) Estimates of severe natural events to be used for deriving 
design bases that will be based on consideration of historical data on 
the associated parameters, physical data, or analysis of upper limits 
of the physical processes involved; and
    (2) Estimates of severe external human-induced events, to be used 
for deriving design bases, that will be based on analysis of human 
activity in the region, taking into account the site characteristics 
and the risks associated with the event.
    Design basis events means:
    (1) Those natural and human-induced events that are expected to 
occur one or more times before permanent closure of the geologic 
repository operations area (referred to as Category 1 events); and
    (2) Other natural and man-induced events that have at least one 
chance in 10,000 of occurring before permanent closure of the geologic 
repository (referred to as Category 2 events).
    Director means the Director of the Nuclear Regulatory Commission's 
Office of Nuclear Material Safety and Safeguards.
    Disposal means the emplacement of radioactive wastes in a geologic 
repository with the intent of leaving it there permanently.
    DOE means the U.S. Department of Energy or its duly authorized 
representatives.
    Engineered barrier system means the waste packages and the 
underground facility.
    Expected annual dose means the expected value of the annual dose

[[Page 8665]]

considering the probability of the occurrence of the events and the 
uncertainty, or variability, in parameter values used to describe the 
behavior of the geologic repository.
    Geologic repository means a system that is intended to be used for, 
or may be used for, the disposal of radioactive wastes in excavated 
geologic media. A geologic repository includes: The engineered barrier 
system, and the portion of the geologic setting that provides isolation 
of the radioactive waste.
    Geologic repository operations area means a high-level radioactive 
waste facility that is part of a geologic repository, including both 
surface and subsurface areas, where waste handling activities are 
conducted.
    Geologic setting means the geologic, hydrologic, and geochemical 
systems of the region in which a geologic repository is or may be 
located.
    Groundwater means all liquid water that occurs below the land 
surface.
    High-level radioactive waste or HLW means:
    (1) Irradiated reactor fuel;
    (2) Liquid wastes resulting from the operation of the first-cycle 
solvent extraction system, or equivalent, and the concentrated wastes 
from subsequent extraction cycles, or equivalent, in a facility for 
reprocessing irradiated reactor fuel; and
    (3) Solids into which such liquid wastes have been converted.
    HLW facility means a facility subject to the licensing and related 
regulatory authority of the Commission pursuant to Sections 202(3) and 
202(4) of the Energy Reorganization Act of 1974 (88 Stat. 1244) 
1
---------------------------------------------------------------------------

    \1\ These are DOE ``facilities used primarily for the receipt 
and storage of high-level radioactive wastes resulting from 
activities licensed under such Act [the Atomic Energy Act]'' and 
``Retrievable Surface Storage Facilities and other facilities 
authorized for the express purpose of subsequent long-term storage 
of high-level radioactive wastes generated by [DOE], which are not 
used for, or are part of, research and development activities.''
---------------------------------------------------------------------------

    Host rock means the geologic medium in which the waste is emplaced.
    Important to safety, with reference to structures, systems, and 
components, means those engineered features of the geologic repository 
operations area whose function is:
    (1) To provide reasonable assurance that high-level waste can be 
received, handled, packaged, stored, emplaced, and retrieved without 
exceeding the requirements of Sec. 63.111(b)(1) for Category 1 design 
basis events; or
    (2) To prevent or mitigate Category 2 design basis events that 
could result in doses equal to or greater than the values specified in 
Sec. 63.111(b)(2) to any individual located on or beyond any point on 
the boundary of the site.
    Important to waste isolation, with reference to design of the 
engineered barrier system and characterization of natural barriers, 
means those engineered and natural barriers whose function is to 
provide reasonable assurance that high-level waste can be disposed 
without exceeding the requirements of Sec. 63.113(b).
    Integrated safety analysis means an analysis to identify hazards 
and their potential for initiating event sequences, the potential event 
sequences and their consequences, and the site, structures, systems, 
components, equipment, and activities of personnel, that are relied on 
for safety. As used here, integrated means joint consideration of 
safety measures that otherwise might conflict, including, but not 
limited to, integration of fire protection, radiation safety, 
criticality safety, and chemical safety measures.
    Isolation means inhibiting the transport of radioactive material to 
the location of the critical group so that radiation exposures will not 
exceed the requirements of Sec. 63.113(b).
    Performance assessment means a probabilistic analysis that:
    (1) Identifies the features, events and processes that might affect 
the performance of the geologic repository; and
    (2) Examines the effects of such features, events, and processes on 
the performance of the geologic repository; and
    (3) Estimates the expected annual dose to the average member of the 
critical group as a result of releases from the geologic repository.
    Performance confirmation means the program of tests, experiments, 
and analyses that is conducted to evaluate the accuracy and adequacy of 
the information used to determine with reasonable assurance that the 
performance objective at Sec. 63.113(b) will be met.
    Permanent closure means final backfilling of the underground 
facility, if appropriate, and the sealing of shafts, ramps, and 
boreholes.
    Public Document Room means the place at 2120 L Street NW., 
Washington, DC, at which records of the Commission will ordinarily be 
made available for public inspection and any other place, the location 
of which has been published in the Federal Register, at which public 
records of the Commission pertaining to a geologic repository at the 
Yucca Mountain site are made available for public inspection.
    Radioactive waste or waste means HLW and radioactive materials 
other than HLW that are received for emplacement in a geologic 
repository.
    Reference biosphere means the description of the environment 
inhabited by the critical group. The reference biosphere comprises the 
set of specific biotic and abiotic characteristics of the environment, 
including, but not necessarily limited to, climate, topography, soils, 
flora, fauna, and human activities.
    Restricted area means an area, access to which is limited by the 
licensee for the purpose of protecting individuals against undue risks 
from exposure to radiation and radioactive materials. Restricted area 
does not include areas used as residential quarters, but separate rooms 
in a residential building may be set aside as a restricted area.
    Retrieval means the act of intentionally removing radioactive waste 
from the underground location at which the waste had been previously 
emplaced for disposal.
    Saturated zone means that part of the earth's crust beneath the 
regional water table in which all voids, large and small, are ideally 
filled with water under pressure greater than atmospheric.
    Site means that area surrounding the geologic repository operations 
area for which DOE exercises authority over its use in accordance with 
the provisions of this part.
    Site characterization means the program of exploration and 
research, both in the laboratory and in the field, undertaken to 
establish the geologic conditions and the ranges of those parameters of 
the Yucca Mountain site, and the surrounding region to the extent 
necessary, relevant to the procedures under this part. Site 
characterization includes borings, surface excavations, excavation of 
exploratory shafts and/or ramps, limited subsurface lateral excavations 
and borings, and in situ testing at depth needed to determine the 
suitability of the site for a geologic repository.
    Underground facility means the underground structure, backfill 
materials, if any, and openings that penetrate the underground 
structure (e.g., ramps, shafts, and boreholes, including their seals).
    Unrestricted area means an area, access to which is neither limited 
nor controlled by the licensee.
    Unsaturated zone means the zone between the land surface and the 
regional water table. Generally, fluid pressure in this zone is less 
than atmospheric pressure, and some of the voids may contain air or 
other gases at atmospheric pressure. Beneath flooded

[[Page 8666]]

areas or in perched water bodies, the fluid pressure locally may be 
greater than atmospheric.
    Waste form means the radioactive waste materials and any 
encapsulating or stabilizing matrix.
    Waste package means the waste form and any containers, shielding, 
packing, and other absorbent materials immediately surrounding an 
individual waste container.
    Water table means that surface in a groundwater body, separating 
the unsaturated zone from the saturated zone, at which the water 
pressure is atmospheric.


Sec. 63.3  License required.

    (a) DOE shall not receive nor possess source, special nuclear, or 
byproduct material at a geologic repository operations area at the 
Yucca Mountain site except as authorized by a license issued by the 
Commission pursuant to this part.
    (b) DOE shall not begin construction of a geologic repository 
operations area at the Yucca Mountain site unless it has filed an 
application with the Commission and has obtained construction 
authorization as provided in this part. Failure to comply with this 
requirement shall be grounds for denial of a license.


Sec. 63.4  Communications and records.

    (a) Except where otherwise specified, all communications and 
reports concerning the regulations in this part and applications filed 
under them should be addressed to the Director of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001. Communications, reports, and applications may be 
delivered in person at the Commission's offices at 2120 L Street NW, 
Washington DC, or 11555 Rockville Pike, Rockville, MD.
    (b) Each record required by this part must be legible throughout 
the retention period specified by each Commission regulation. The 
record may be the original or a reproduced copy or a microform provided 
that the copy or microform is authenticated by authorized personnel and 
that the microform is capable of producing a clear copy throughout the 
required retention period. The record may also be stored in electronic 
media with the capability for producing legible, accurate, and complete 
records during the required retention period. Records such as letters, 
drawings, and specifications must include all pertinent information 
such as stamps, initials, and signatures. The licensee shall maintain 
adequate safeguards against tampering with and loss of records.


Sec. 63.5  Interpretations.

    Except as specifically authorized by the Commission in writing, no 
interpretation of the meaning of the regulations in this part by any 
officer or employee of the Commission other than a written 
interpretation by the General Counsel will be considered binding on the 
Commission.


Sec. 63.6  Exemptions.

    The Commission may, upon application by DOE, any interested person, 
or upon its own initiative, grant such exemptions from the requirements 
of the regulations in this part as it determines are authorized by law, 
will not endanger life nor property nor the common defense and 
security, and are otherwise in the public interest.


Sec. 63.7  License not required for certain preliminary activities.

    The requirement for a license set forth in Sec. 63.3(a) is not 
applicable to the extent that DOE receives and possesses source, 
special nuclear, and byproduct material at a geologic repository at the 
Yucca Mountain site:
    (a) For purposes of site characterization; or
    (b) For use, during site characterization or construction, as 
components of radiographic, radiation monitoring, or similar equipment 
or instrumentation.


Sec. 63.8  Information collection requirements: OMB approval.

    (a) The U.S. Nuclear Regulatory Commission has submitted the 
information collection requirements of general applicability contained 
in this part to the Office of Management and Budget for approval, as 
required by the Paperwork Reduction Act (44 U.S.C. 3501, et seq.). The 
Office of Management and Budget has approved the information collection 
requirements contained in this part under control number 3150-XXXX.
    (b) The approved information collection requirements contained in 
this part appear in Secs. 63.62, 63.63, and 63.65.


Sec. 63.9  Employee protection.

    (a) Discrimination by a Commission licensee, an applicant for a 
Commission license, or a contractor or subcontractor of a Commission 
licensee or applicant, against an employee, for engaging in certain 
protected activities, is prohibited. Discrimination includes discharge 
and other actions that relate to compensation, terms, conditions, or 
privileges of employment. The protected activities are established in 
Section 211 of the Energy Reorganization Act of 1974, as amended, and 
in general are related to the administration or enforcement of a 
requirement imposed under the Atomic Energy Act or the Energy 
Reorganization Act.
    (1) The protected activities include but are not limited to:
    (i) Providing the Commission, or his or her employer, information 
about alleged violations of either of the statutes named in paragraph 
(a) of this section or possible violations of requirements imposed 
under either of those aforementioned statutes;
    (ii) Refusing to engage in any practice made unlawful under either 
of the statutes named in paragraph (a) of this section, or under these 
requirements, if the employee has identified the alleged illegality to 
the employer;
    (iii) Requesting the Commission to institute action against his or 
her employer for the administration or enforcement of these 
requirements;
    (iv) Testifying in any Commission proceeding, or before Congress, 
or at any Federal or State proceeding regarding any provision (or 
proposed provision) of either of the statutes named in paragraph (a) of 
this section;
    (v) Assisting or participating in, or is about to assist or 
participate in, these activities.
    (2) These activities are protected even if no formal proceeding is 
actually initiated as a result of the employee assistance or 
participation.
    (3) This section has no application to any employee alleging 
discrimination prohibited by this section who, acting without direction 
from his or her employer (or the employer's agent), deliberately causes 
a violation of any requirement of the Energy Reorganization Act of 
1974, as amended, or the Atomic Energy Act of 1954, as amended.
    (b) Any employee who believes that he or she has been discharged or 
otherwise discriminated against by any person for engaging in protected 
activities specified in paragraph (a)(1) of this section may seek a 
remedy for the discharge or discrimination through an administrative 
proceeding in the Department of Labor. The administrative proceeding 
must be initiated within 180 days after an alleged violation occurs. 
The employee may do this by filing a complaint alleging the violation 
with the Department of Labor, Employment Standards Administration, Wage 
and Hour Division. The Department of Labor may order reinstatement, 
back pay, and compensatory damages.

[[Page 8667]]

    (c) A violation of paragraph (a), (e), or (f) of this section by a 
Commission licensee, an applicant for a Commission license, or a 
contractor or subcontractor of a Commission licensee or applicant may 
be grounds for--
    (1) Denial, revocation, or suspension of the license.
    (2) Imposition of a civil penalty on the licensee or applicant.
    (3) Other enforcement action.
    (d) Actions taken by an employer, or others, that adversely affect 
an employee, may be predicated on nondiscriminatory grounds. The 
prohibition applies when the adverse action occurs because the employee 
has engaged in protected activities. An employee's engagement in 
protected activities does not automatically render him or her immune 
from discharge or discipline for legitimate reasons or from adverse 
action dictated by nonprohibited considerations.
    (e)(1) Each licensee and each applicant for a license shall 
prominently post the revision of NRC Form 3, ``Notice to Employees,'' 
referenced in Sec. 19.11(c) of this chapter. This form must be posted 
at locations sufficient to permit employees protected by this section 
to observe a copy on the way to or from their place of work. Premises 
must be posted not later than 30 days after an application is docketed 
and remain posted while the application is pending before the 
Commission, during the term of the license, and for 30 days following 
license termination.
    (2) Copies of NRC Form 3 may be obtained by writing to the Regional 
Administrator of the appropriate U.S. Nuclear Regulatory Commission 
Regional Office listed in Appendix D to Part 20 of this chapter or by 
accessing the NRC Web Site www.nrc.gov/NRC/FORMS/forms3.html.
    (f) No agreement affecting the compensation, terms, conditions, or 
privileges of employment, including an agreement to settle a complaint 
filed by an employee with the Department of Labor pursuant to Section 
211 of the Energy Reorganization Act of 1974, as amended, may contain 
any provision that would prohibit, restrict, or otherwise discourage an 
employee from participating in protected activity as defined in 
paragraph (a)(1) of this section including, but not limited to, 
providing information to NRC or to his or her employer on potential 
violations or other matters within NRC's regulatory responsibilities.


Sec. 63.10  Completeness and accuracy of information.

    (a) Information provided to the Commission by an applicant for a 
license or by a licensee, or information required by statute, or 
required by the Commission's regulations, orders, or license conditions 
to be maintained by the applicant or the licensee shall be complete and 
accurate in all material respects.
    (b) The applicant or licensee shall notify the Commission of 
information identified by the applicant or licensee as having, for the 
regulated activity, a significant implication for public health and 
safety or common defense and security. An applicant or licensee 
violates this paragraph only if the applicant or licensee fails to 
notify the Commission of information that the applicant or licensee has 
identified as having a significant implication for public health and 
safety or common defense and security. Notification shall be provided 
to the Administrator of the appropriate Regional Office within 2 
working days of identifying the information. This requirement is not 
applicable to information that is already required to be provided to 
the Commission by other reporting or updating requirements.


Sec. 63.11  Deliberate misconduct.

    (a) Any licensee, applicant for a license, employee of a licensee 
or applicant; or any contractor (including a supplier or consultant), 
subcontractor, employee of a contractor or subcontractor of any 
licensee or applicant for a license, who knowingly provides to any 
licensee, applicant, contractor, or subcontractor, any components, 
equipment, materials, or other goods or services that relate to a 
licensee's or applicant's activities in this part, may not:
    (1) Engage in deliberate misconduct that causes or would have 
caused, if not detected, a licensee or applicant to be in violation of 
any rule, regulation, or order; or any term, condition, or limitation 
of any license issued by the Commission; or
    (2) Deliberately submit to NRC, a licensee, an applicant, or a 
licensee's or applicant's contractor or subcontractor, information that 
the person submitting the information knows to be incomplete or 
inaccurate in some respect material to NRC.
    (b) A person who violates paragraph (a)(1) or (a)(2) of this 
section may be subject to enforcement action in accordance with the 
procedures in 10 CFR Part 2, Subpart B.
    (c) For purposes of paragraph (a)(1) of this section, deliberate 
misconduct by a person means an intentional act or omission that the 
person knows:
    (1) Would cause a licensee or applicant to be in violation of any 
rule, regulation, or order; or any term, condition, or limitation, of 
any license issued by the Commission; or
    (2) Constitutes a violation of a requirement, procedure, 
instruction, contract, purchase order, or policy of a licensee, 
applicant, contractor, or subcontractor.

Subpart B--Licenses

PREAPPLICATION REVIEW


Sec. 63.15  Site characterization.

    (a) Before submittal of an application for a license to be issued 
under this part, DOE shall conduct a program of site characterization 
with respect to the Yucca Mountain site.
    (b) Investigations to obtain the required information shall be 
conducted in such a manner as to limit, to the extent practical, 
adverse effects on the long-term performance of the geologic repository 
at Yucca Mountain.


Sec. 63.16  Review of site characterization activities.2
---------------------------------------------------------------------------

    \2\ In addition to the review of site characterization 
activities specified in this section, the Commission contemplates an 
ongoing review of other information on site investigation and site 
characterization, to allow early identification of potential 
licensing issues for timely resolution.
---------------------------------------------------------------------------

    (a) If DOE's planned site characterization activities include 
onsite testing with radioactive material, including radioactive 
tracers, the Commission shall determine whether the proposed use of 
such radioactive material is necessary to provide data for the 
preparation of the environmental reports required by law and for an 
application to be submitted under Sec. 63.22.
    (b) During the conduct of site characterization activities at the 
Yucca Mountain site, DOE shall report not less than once every 6 months 
to the Commission on the nature and extent of such activities and the 
information that has been developed, and on the progress of waste form 
and waste package research and development. The semiannual reports 
shall include the results of site characterization studies, the 
identification of new issues, plans for additional studies to resolve 
new issues, elimination of planned studies no longer necessary, 
identification of decision points reached, and modifications to 
schedules, where appropriate. DOE shall also report its progress in 
developing the design of a geologic repository operations area 
appropriate for the area being characterized, noting when key design 
parameters or features that depend on the results of site 
characterization will be established. Other topics related to

[[Page 8668]]

site characterization shall also be covered if requested by the 
Director.
    (c) During the conduct of site characterization activities at the 
Yucca Mountain site, NRC staff shall be permitted to visit and inspect 
the locations at which such activities are carried out and to observe 
excavations, borings, and in-situ tests, as they are done.
    (d) The Director may comment at any time in writing to DOE, 
expressing current views on any aspect of site characterization or 
performance assessment at the Yucca Mountain site. In particular, such 
comments shall be made whenever the Director determines that there are 
substantial grounds for making recommendations or stating objections to 
DOE's site characterization program. The Director shall invite public 
comment on any comments that the Director makes to DOE, on review of 
the DOE semiannual reports, or on any other comments that the Director 
makes to DOE on site characterization and performance assessment.
    (e) The Director shall transmit copies of all comments to DOE made 
by the Director under this section to the Governor and legislature of 
the State of Nevada and to the governing body of any affected Indian 
Tribe.
    (f) All correspondence between DOE and NRC, under this section, 
including the reports described in paragraph (b) of this section, shall 
be placed in the Public Document Room.
    (g) The activities described in paragraphs (a) through (f) of this 
section constitute informal conference between a prospective applicant 
and the NRC staff, as described in Sec. 2.101(a)(1) of this chapter, 
and are not part of a proceeding under the Atomic Energy Act of 1954, 
as amended. Accordingly, the issuance of the Director's comments made 
under this section does not constitute a commitment to issue any 
authorization or license, or in any way affect the authority of the 
Commission, Atomic Safety and Licensing Boards, other presiding 
officers, or the Director, in any such proceeding.
LICENSE APPLICATION


Sec. 63.21  Content of application.

    (a) An application shall consist of general information and a 
Safety Analysis Report. An environmental impact statement shall be 
prepared in accordance with the Nuclear Waste Policy Act of 1982, as 
amended, and shall accompany the application. Any Restricted Data or 
National Security Information shall be separated from unclassified 
information.
    (b) The general information shall include:
    (1) A general description of the proposed geologic repository at 
the Yucca Mountain site, identifying the location of the geologic 
repository operations area, the general character of the proposed 
activities, and the basis for the exercise of the Commission's 
licensing authority.
    (2) Proposed schedules for construction, receipt of waste, and 
emplacement of wastes at the proposed geologic repository operations 
area.
    (3) A detailed plan to provide physical protection of high-level 
radioactive waste in accordance with Sec. 73.51 of this chapter. This 
plan must include the design for physical protection, the licensee's 
safeguards contingency plan, and security organization personnel 
training and qualification plan. The plan must list tests, inspections, 
audits, and other means to be used to demonstrate compliance with such 
requirements.
    (4) A description of the material control and accounting program to 
meet the requirements of Sec. 63.78.
    (5) A description of work conducted to characterize the Yucca 
Mountain site.
    (c) The Safety Analysis Report shall include:
    (1) A description of the Yucca Mountain site, with appropriate 
attention to those features, events, and processes of the site that 
might affect design of the geologic repository operations area and 
performance of the geologic repository. The description of the site 
shall include information regarding features, events, and processes 
outside of the site to the extent the information is relevant and 
material to safety or performance of the geologic repository. The 
information referred to in this paragraph shall include:
    (i) The location of the geologic repository operations area with 
respect to the boundary of the site;
    (ii) Information regarding the geology, hydrology, and geochemistry 
of the site, including geomechanical properties and conditions of the 
host rock;
    (iii) Information regarding surface water hydrology, climatology, 
and meteorology of the site;
    (iv) Information regarding the location of the critical group, and 
regarding local human behaviors and characteristics, as needed to 
support selection of conceptual models and parameters used for the 
reference biosphere and critical group.
    (2) An integrated safety analysis of the geologic repository 
operations area, for the period before permanent closure, to ensure 
compliance with Sec. 63.111(a), as required by Sec. 63.111(c). For the 
purposes of this analysis, it shall be assumed that operations at the 
geologic repository operations area will be carried out at the maximum 
capacity and rate of receipt of radioactive waste stated in the 
application.
    (3) Information relative to materials of construction of the 
geologic repository operations area (including geologic media, general 
arrangement, and approximate dimensions), and codes and standards that 
DOE proposes to apply to the design and construction of the geologic 
repository operations area.
    (4) A description and discussion of the design of the engineered 
barrier system including:
    (i) The principal design criteria and their relationships to the 
postclosure performance objective specified at Sec. 63.113(b); and
    (ii) The design bases and their relation to the principal design 
criteria.
    (5) An assessment to determine the degree to which those features, 
events, and processes of the site that are expected to materially 
affect compliance with Sec. 63.113(b)--whether beneficial or 
potentially adverse to performance of the geologic repository--have 
been characterized, and the extent to which they affect waste 
isolation. Investigations shall extend from the surface to a depth 
sufficient to determine principal pathways for radionuclide migration 
from the underground facility. Specific features, events, and processes 
of the geologic setting shall be investigated outside of the site if 
they affect performance of the geologic repository.
    (6) An assessment of the anticipated response of the geomechanical, 
hydrogeologic, and geochemical systems to the range of design thermal 
loadings under consideration, given the pattern of fractures and other 
discontinuities and the heat transfer properties of the rock mass and 
groundwater.
    (7) An assessment of the performance of the proposed geologic 
repository for the period after permanent closure, as required by 
Sec. 63.113(c). The assessment shall also include a comparative 
evaluation of alternatives to the major design features that are 
important to waste isolation, with particular attention to the 
alternatives that would provide longer containment and isolation of 
radioactive materials.
    (8) An assessment of the ability of the proposed geologic 
repository to limit radiological exposures in the event of limited 
human intrusion into the engineered barrier system as required by 
Sec. 63.113(d).
    (9) An explanation of measures used to support the models used to 
perform the assessments required in paragraphs (c)(5) through (c)(8) of 
this section. Analyses and models that will be used

[[Page 8669]]

to assess performance of the geologic repository shall be supported by 
using an appropriate combination of such methods as field tests, in-
situ tests, laboratory tests that are representative of field 
conditions, monitoring data, and natural analog studies.
    (10) An explanation of how expert elicitation was used in the 
assessments required in paragraphs (c)(5) through (c)(8) of this 
section.
    (11) A description of the quality assurance program to be applied 
to the structures, systems, and components important to safety and to 
the engineered and natural barriers important to waste isolation.
    (12) A description of the kind, amount, and specifications of the 
radioactive material proposed to be received and possessed at the 
geologic repository operations area at the Yucca Mountain site.
    (13) An identification and justification for the selection of those 
variables, conditions, or other items that are determined to be 
probable subjects of license specifications. Special attention shall be 
given to those items that may significantly influence the final design.
    (14) A description of the program for control and monitoring of 
radioactive effluents and occupational radiation exposures to maintain 
such effluents and exposures in accordance with the requirements of 
Sec. 63.111.
    (15) A description of the controls that DOE will apply to restrict 
access and to regulate land use at the Yucca Mountain site and adjacent 
areas, including a conceptual design of monuments that would be used to 
identify the site after permanent closure.
    (16) A description of the plan for responding to, and recovering 
from, radiological emergencies that may occur at any time before 
permanent closure and decontamination or dismantlement of surface 
facilities, as required by Sec. 63.161.
    (17) A description of the program to be used to maintain the 
records described in Secs. 63.71 and 63.72.
    (18) A description of design considerations that are intended to 
facilitate permanent closure and decontamination or dismantlement of 
surface facilities.
    (19) A description of plans for retrieval and alternate storage of 
the radioactive wastes, should retrieval be necessary.
    (20) A description of the performance confirmation program that 
meets the requirements of Subpart F.
    (21) An identification of those structures, systems, and components 
of the geologic repository, both surface and subsurface, which require 
research and development to confirm the adequacy of design. For 
structures, systems, and components important to safety and for the 
engineered and natural barriers important to waste isolation, DOE shall 
provide a detailed description of the programs designed to resolve 
safety questions, including a schedule indicating when these questions 
would be resolved.
    (22) The following information concerning activities at the 
geologic repository operations area:
    (i) The organizational structure of DOE as it pertains to 
construction and operation of the geologic repository operations area, 
including a description of any delegations of authority and assignments 
of responsibilities, whether in the form of regulations, administrative 
directives, contract provisions, or otherwise.
    (ii) Identification of key positions that are assigned 
responsibility for safety at and operation of the geologic repository 
operations area.
    (iii) Personnel qualifications and training requirements.
    (iv) Plans for startup activities and startup testing.
    (v) Plans for conduct of normal activities, including maintenance, 
surveillance, and periodic testing of structures, systems, and 
components of the geologic repository operations area.
    (vi) Plans for permanent closure and plans for the decontamination 
or dismantlement of surface facilities.
    (vii) Plans for any uses of the geologic repository operations area 
at the Yucca Mountain site for purposes other than disposal of 
radioactive wastes, with an analysis of the effects, if any, that such 
uses may have on the operation of the structures, systems, and 
components important to safety and the engineered and natural barriers 
important to waste isolation.


Sec. 63.22  Filing and distribution of application.

    (a) An application for a license to receive and possess source, 
special nuclear, or byproduct material at a geologic repository 
operations area, at the Yucca Mountain site, that has been 
characterized, and any amendments thereto, and an accompanying 
environmental impact statement and any supplements, shall be signed by 
the Secretary of Energy or the Secretary's authorized representative 
and shall be filed in triplicate with the Director.
    (b) Each portion of such application and any amendments, and each 
environmental impact statement and any supplements, shall be 
accompanied by 30 additional copies. Another 120 copies shall be 
retained by DOE for distribution in accordance with written 
instructions from the Director or the Director's designee.
    (c) DOE shall, on notification of the appointment of an Atomic 
Safety and Licensing Board, update the application, eliminating all 
superseded information, and supplement the environmental impact 
statement if necessary, and serve the updated application and 
environmental impact statement (as it may have been supplemented) as 
directed by the Board. Any subsequent amendments to the application or 
supplements to the environmental impact statement shall be served in 
the same manner.
    (d) At the time of filing of an application and any amendments 
thereto, copies shall be made available in appropriate locations near 
the proposed geologic repository operations area at the Yucca Mountain 
site, for inspection by the public, and updated as amendments to the 
application are made. The environmental impact statement and any 
supplements thereto shall be made available in the same manner. An 
updated copy of the application, and the environmental impact statement 
and supplements, shall be produced at any public hearing held by the 
Commission on the application, for use by any party to the proceeding.
    (e) DOE shall certify that the updated copies of the application, 
and the environmental impact statement as it may have been 
supplemented, as referred to in paragraphs (c) and (d) of this section, 
contain the current contents of such documents submitted in accordance 
with the requirements of this part.


Sec. 63.23  Elimination of repetition.

    In its application or environmental impact statement, DOE may 
incorporate, by reference, information contained in previous 
applications, statements, or reports filed with the Commission, 
provided, that such references are clear and specific and that copies 
of the information so incorporated are made available to the public 
locations near the site of the proposed geologic repository, as 
provided pursuant to Sec. 63.22(d).


Sec. 63.24  Updating of application and environmental impact statement.

    (a) The application shall be as complete as possible in the light 
of information that is reasonably available at the time of docketing.
    (b) DOE shall update its application in a timely manner so as to 
permit the Commission to review, before issuance of a license:

[[Page 8670]]

    (1) Additional geologic, geophysical, geochemical, hydrologic, 
meteorologic, materials, design, and other data obtained during 
construction.
    (2) Conformance of construction of structures, systems, and 
components with the design.
    (3) Results of research programs carried out to confirm the 
adequacy of designs, conceptual models, parameter values, and estimates 
of performance of the geologic repository.
    (4) Other information bearing on the Commission's issuance of a 
license that was not available at the time a construction authorization 
was issued.
    (c) DOE shall supplement its environmental impact statement in a 
timely manner so as to take into account the environmental impacts of 
any substantial changes in its proposed actions or any significant new 
circumstances or information relevant to environmental concerns bearing 
on the proposed action or its impacts.
CONSTRUCTION AUTHORIZATION


Sec. 63.31  Construction authorization.

    On review and consideration of an application and environmental 
impact statement submitted under this part, the Commission may 
authorize construction of a geologic repository operations area at the 
Yucca Mountain site if it determines:
    (a) Safety. That there is reasonable assurance that the types and 
amounts of radioactive materials described in the application can be 
received, possessed, and disposed of in a geologic repository 
operations area of the design proposed without unreasonable risk to the 
health and safety of the public. In arriving at this determination, the 
Commission shall consider whether:
    (1) DOE has described the proposed geologic repository as specified 
at Sec. 63.21.
    (2) The site and design comply with the performance objectives and 
requirements contained in Subpart E of this part.
    (3) DOE's quality assurance program complies with the requirements 
of Subpart G of this part.
    (4) DOE's personnel training program complies with the criteria 
contained in Subpart H of this part.
    (5) DOE's emergency plan complies with the criteria contained in 
Subpart I of this part.
    (6) DOE's proposed operating procedures to protect health and to 
minimize danger to life or property are adequate.
    (b) Common defense and security. That there is reasonable assurance 
that the activities proposed in the application will not be inimical to 
the common defense and security.
    (c) Environmental. That, after weighing the environmental, 
economic, technical, and other benefits against environmental costs, 
and considering available alternatives, the action called for is 
issuance of the construction authorization, with any appropriate 
conditions to protect environmental values.


Sec. 63.32  Conditions of construction authorization.

    (a) A construction authorization for a geologic repository 
operations area at the Yucca Mountain site shall include such 
conditions as the Commission finds to be necessary to protect the 
health and safety of the public, the common defense and security, or 
environmental values.
    (b) The Commission will incorporate, in the construction 
authorization, provisions requiring DOE to furnish periodic or special 
reports regarding:
    (1) Progress of construction;
    (2) Any data about the site, obtained during construction, that are 
not within the predicted limits on which the facility design was based;
    (3) Any deficiencies, in design and construction, that, if 
uncorrected, could adversely affect safety at any future time; and
    (4) Results of research and development programs being conducted to 
resolve safety questions.
    (c) The construction authorization for a geologic repository 
operations area at the Yucca Mountain site will include restrictions on 
subsequent changes to the features of the geologic repository and the 
procedures authorized. The restrictions that may be imposed under this 
paragraph can include measures to prevent adverse effects on the 
geologic setting as well as measures related to the design and 
construction of the geologic repository operations area. These 
restrictions will fall into three categories of descending importance 
to public health and safety, as follows:
    (1) Those features and procedures that may not be changed without:
    (i) 60 days prior notice to the Commission;
    (ii) 30 days notice of opportunity for a prior hearing; and
    (iii) Prior Commission approval;
    (2) Those features and procedures that may not be changed without:
    (i) 60 days prior notice to the Commission; and
    (ii) Prior Commission approval; and
    (3) Those features and procedures that may not be changed without 
60 days notice to the Commission. Features and procedures falling in 
this paragraph section may not be changed without prior Commission 
approval if the Commission, after having received the required notice, 
so orders.
    (d) A construction authorization shall be subject to the limitation 
that a license to receive and possess source, special nuclear, or 
byproduct material at the Yucca Mountain site geologic repository 
operations area shall not be issued by the Commission until;
    (1) DOE has updated its application, as specified in Sec. 63.24; 
and
    (2) The Commission has made the findings stated in Sec. 63.41.


Sec. 63.33  Amendment of construction authorization.

    (a) An application for amendment of a construction authorization 
shall be filed with the Commission, fully describing any changes 
desired and following as far as applicable the contents prescribed in 
Sec. 63.21.
    (b) In determining whether an amendment of a construction 
authorization will be approved, the Commission will be guided by the 
considerations that govern the issuance of the initial construction 
authorization, to the extent applicable.
LICENSE ISSUANCE AND AMENDMENT


Sec. 63.41  Standards for issuance of a license.

    A license to receive and possess source, special nuclear, or 
byproduct material at a geologic repository operations area at the 
Yucca Mountain site may be issued by the Commission, on finding that:
    (a) Construction of the geologic repository operations area has 
been substantially completed in conformity with the application as 
amended, the provisions of the Atomic Energy Act, and the rules and 
regulations of the Commission. Construction may be deemed to be 
substantially complete for the purposes of this paragraph if the 
construction of:
    (1) Surface and interconnecting structures, systems, and 
components; and
    (2) Any underground storage space required for initial operation, 
are substantially complete.
    (b) The activities to be conducted at the geologic repository 
operations area will be in conformity with the application as amended, 
the provisions of the Atomic Energy Act and the Energy Reorganization 
Act, and the rules and regulations of the Commission.
    (c) The issuance of the license will not be inimical to the common 
defense and security and will not constitute an

[[Page 8671]]

unreasonable risk to the health and safety of the public.
    (d) Adequate protective measures can and will be taken in the event 
of a radiological emergency at any time before permanent closure and 
decontamination or dismantlement of surface facilities.
    (e) All applicable requirements of Part 51 of this chapter have 
been satisfied.


Sec. 63.42  Conditions of license.

    (a) A license issued pursuant to this part shall include such 
conditions, including license specifications, as the Commission finds 
to be necessary to protect the health and safety of the public, the 
common defense and security, and environmental values.
    (b) Whether stated therein or not, the following shall be deemed 
conditions in every license issued:
    (1) The license shall be subject to revocation, suspension, 
modification, or amendment for cause, as provided by the Atomic Energy 
Act and the Commission's regulations.
    (2) DOE shall, at any time while the license is in effect, on 
written request of the Commission, submit written statements to enable 
the Commission to determine whether or not the license should be 
modified, suspended, or revoked.
    (3) The license shall be subject to the provisions of the Atomic 
Energy Act now or hereafter in effect and to all rules, regulations, 
and orders of the Commission. The terms and conditions of the license 
shall be subject to amendment, revision, or modification, by reason of 
amendments to or by reason of rules, regulations, and orders issued in 
accordance with the terms of the Atomic Energy Act.
    (c) Each license shall be deemed to contain the provisions set 
forth in Section 183 b-d, inclusive, of the Atomic Energy Act, whether 
or not these provisions are expressly set forth in the license.
    (d) A license issued under this part shall be deemed to contain the 
provisions set forth in Section 114(d) of the Nuclear Waste Policy Act, 
prohibiting emplacement of a quantity of spent fuel containing in 
excess of 70,000 metric tons of heavy metal or a quantity of solidified 
high-level radioactive waste resulting from the reprocessing of such a 
quantity of spent fuel, until such time as a second repository is in 
operation, whether or not these provisions are expressly set forth in 
the license.


Sec. 63.43  License specification.

    (a) A license issued under this part shall include license 
conditions derived from the analyses and evaluations included in the 
application, including amendments made before a license is issued, 
together with such additional conditions as the Commission finds 
appropriate.
    (b) License conditions shall include items in the following 
categories:
    (1) Restrictions as to the physical and chemical form and 
radioisotopic content of radioactive waste.
    (2) Restrictions as to size, shape, and materials and methods of 
construction of radioactive waste packaging.
    (3) Restrictions as to the amount of waste permitted per unit 
volume of storage space, considering the physical characteristics of 
both the waste and the host rock.
    (4) Requirements relating to test, calibration, or inspection, to 
assure that the foregoing restrictions are observed.
    (5) Controls to be applied to restrict access and to avoid 
disturbance to the site and to areas outside the site where conditions 
may affect compliance with Secs. 63.111 and 63.113.
    (6) Administrative controls, which are the provisions relating to 
organization and management, procedures, recordkeeping, review and 
audit, and reporting necessary to assure that activities at the 
facility are conducted in a safe manner and in conformity with the 
other license specifications.


Sec. 63.44  Changes, tests, and experiments.

    (a)(1) Following authorization to receive and possess source, 
special nuclear, or byproduct material at a geologic repository 
operations area at the Yucca Mountain site, DOE may:
    (i) Make changes in the geologic repository operations area as 
described in the application;
    (ii) Make changes in the procedures as described in the 
application; and
    (iii) Conduct tests or experiments not described in the 
application, without prior Commission approval, provided the change, 
test, or experiment involves neither a change in the license conditions 
incorporated in the license nor an unreviewed safety question.
    (2) A proposed change, test, or experiment shall be deemed to 
involve an unreviewed safety question if:
    (i) The likelihood of occurrence or the consequences of an accident 
or malfunction of equipment important to safety previously evaluated in 
the application is increased;
    (ii) The possibility of an accident or malfunction of a different 
type than any previously evaluated in the application is created; or
    (iii) The margin of safety, as defined in the basis for any license 
condition, is reduced.
    (b) DOE shall maintain records of changes in the geologic 
repository operations area at the Yucca Mountain site and of changes in 
procedures made pursuant to this section, to the extent that such 
changes constitute changes in the geologic repository operations area 
or procedures as described in the application. Records of tests and 
experiments carried out pursuant to paragraph (a) of this section shall 
also be maintained. These records shall include a written safety 
evaluation that provides the basis for the determination that the 
change, test, or experiment does not involve an unreviewed safety 
question. DOE shall prepare annually, or at such shorter intervals as 
may be specified in the license, a report containing a brief 
description of such changes, tests, and experiments, including a 
summary of the safety evaluation of each. DOE shall furnish the report 
to the appropriate NRC Regional Office shown in Appendix D of Part 20 
of this chapter, with a copy to the Director, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555. Any report submitted pursuant to this paragraph 
shall be made a part of the public record of the licensing proceedings.


Sec. 63.45  Amendment of license.

    (a) An application for amendment of a license may be filed with the 
Commission fully describing the changes desired and following as far as 
applicable the format prescribed for license applications.
    (b) In determining whether an amendment of a license will be 
approved, the Commission will be guided by the considerations that 
govern the issuance of the initial license, to the extent applicable.


Sec. 63.46  Particular activities requiring license amendment.

    (a) Unless expressly authorized in the license, an amendment of the 
license shall be required with respect to any of the following 
activities:
    (1) Any action that would make emplaced high-level radioactive 
waste irretrievable or which would substantially increase the 
difficulty of retrieving such emplaced waste;
    (2) Dismantling of structures;
    (3) Removal or reduction of controls applied to restrict access to 
or avoid disturbance of the site and to areas outside the site where 
conditions may affect compliance with Secs. 63.111 and 63.113;
    (4) Destruction or disposal of records required to be maintained 
under the provisions of this part;

[[Page 8672]]

    (5) Any substantial change to the design or operating procedures 
from that specified in the license, except as authorized in Sec. 63.44;
    (6) Permanent closure; and
    (7) Any other activity involving an unreviewed safety question.
    (b) An application for such an amendment shall be filed, and shall 
be reviewed, in accordance with the provisions of Sec. 63.45.
PERMANENT CLOSURE


Sec. 63.51  License amendment for permanent closure.

    (a) DOE shall submit an application to amend the license before 
permanent closure of a geologic repository at the Yucca Mountain site. 
The submission shall consist of an update of the license application 
submitted under Secs. 63.21 and 63.22, including:
    (1) An update of the assessment of the performance of the geologic 
repository for the period after permanent closure.
    (2) A description of the program for post-permanent closure 
monitoring of the geologic repository.
    (3) A detailed description of the measures to be employed--such as 
land use controls, construction of monuments, and preservation of 
records--to regulate or prevent activities that could impair the long-
term isolation of emplaced waste within the geologic repository and to 
assure that relevant information will be preserved for the use of 
future generations. As a minimum, such measures shall include:
    (i) Identification of the site and geologic repository operations 
area by monuments that have been designed, fabricated, and emplaced to 
be as permanent as is practicable;
    (ii) Placement of records in the archives and land record systems 
of local, State, and Federal government agencies, and archives 
elsewhere in the world, that would be likely to be consulted by 
potential human intruders--such records to identify the location of the 
geologic repository operations area, including the underground 
facility, boreholes, shafts and ramps, and the boundaries of the site, 
and the nature and hazard of the waste; and
    (iii) A program for continued oversight, to prevent any activity at 
the site that poses an unreasonable risk of breaching the geologic 
repository's engineered barriers; or increasing the exposure of 
individual members of the public to radiation beyond allowable limits.
    (4) Geologic, geophysical, geochemical, hydrologic, and other site 
data that are obtained during the operational period, pertinent to 
compliance with Sec. 63.113.
    (5) The results of tests, experiments, and any other analyses 
relating to backfill of excavated areas, shaft, borehole, or ramp 
sealing, waste interaction with the host rock, and any other tests, 
experiments, or analyses pertinent to compliance with Sec. 63.113.
    (6) Any substantial revision of plans for permanent closure.
    (7) Other information bearing on permanent closure that was not 
available at the time a license was issued.
    (b) If necessary, so as to take into account the environmental 
impact of any substantial changes in the permanent closure activities 
proposed to be carried out or any significant new information regarding 
the environmental impacts of such closure, DOE shall also supplement 
its environmental impact statement and submit such statement, as 
supplemented, with the application for license amendment.


Sec. 63.52  Termination of license.

    (a) Following permanent closure and the decontamination or 
dismantlement of surface facilities at the Yucca Mountain site, DOE may 
apply for an amendment to terminate the license.
    (b) Such application shall be filed and will be reviewed in 
accordance with the provisions of Sec. 63.45 and this section.
    (c) A license shall be terminated only when the Commission finds 
with respect to the geologic repository:
    (1) That the final disposition of radioactive wastes has been made 
in conformance with DOE's plan, as amended and approved as part of the 
license.
    (2) That the final state of the geologic repository operations area 
conforms to DOE's plans for permanent closure and DOE's plans for the 
decontamination or dismantlement of surface facilities, as amended and 
approved as part of the license.
    (3) That the termination of the license is authorized by law, 
including Sections 57, 62, and 81 of the Atomic Energy Act, as amended.

Subpart C--Participation by State Government and Affected Indian 
Tribes


Sec. 63.61  Provision of information.

    (a) The Director shall provide to the Governor and the Nevada State 
legislature, and to the governing body of any affected Indian Tribe, 
timely and complete information regarding determinations or plans made 
by the Commission with respect to the site characterization, siting, 
development, design, licensing, construction, operation, regulation, 
permanent closure, or decontamination and dismantlement of surface 
facilities, of the geologic repository operations area at the Yucca 
Mountain site.
    (b) Notwithstanding paragraph (a) of this section, the Director is 
not required to distribute any document to any entity if, with respect 
to such document, that entity or its counsel is included on a service 
list prepared pursuant to Part 2 of this chapter.
    (c) Copies of all communications by the Director under this section 
shall be placed in the Public Document Room, and copies thereof shall 
be furnished to DOE.


Sec. 63.62  Site review.

    (a) The Director shall make NRC staff available to consult with 
representatives of the State of Nevada and affected Indian Tribes 
regarding the status of site characterization at the Yucca Mountain 
site.
    (b) Requests for consultation shall be made in writing to the 
Director.
    (c) Consultation under this section may include:
    (1) Keeping the parties informed of the Director's views on the 
progress of site characterization.
    (2) Review of applicable NRC regulations, licensing procedures, 
schedules, and opportunities for State and Tribe participation in the 
Commission's regulatory activities.
    (3) Cooperation in development of proposals for State and Tribe 
participation in license reviews.


Sec. 63.63  Participation in license reviews.

    (a) State and local governments and affected Indian Tribes may 
participate in license reviews as provided in Subpart G of Part 2 of 
this chapter. The State of Nevada and any affected Indian Tribe shall 
have an unquestionable legal right to participate as a party in such 
proceedings.
    (b) In addition, a State or an affected Indian Tribe may submit to 
the Director a proposal to facilitate its participation in the review 
of the license application. The proposal may be submitted at any time 
and shall contain a description and schedule of how the State or 
affected Indian Tribe wishes to participate in the review, or what 
services or activities the State or affected Indian Tribe wishes NRC to 
carry out, and how the services or activities proposed to be carried 
out by NRC would contribute to such participation. The proposal may 
include educational or information services (seminars, public meetings) 
or other actions on the part of NRC, such as

[[Page 8673]]

establishing additional public document rooms or employment or exchange 
of State personnel under the Intergovernmental Personnel Act.
    (c) The Director shall arrange for a meeting between the 
representatives of the State or affected Indian Tribe and the NRC 
staff, to discuss any proposal submitted under paragraph (b) of this 
section, with a view to identifying any modifications that may 
contribute to the effective participation by such State or Tribe.
    (d) Subject to the availability of funds, the Director shall 
approve all or any part of a proposal, as it may be modified through 
the meeting described above, if it is determined that:
    (1) The proposed activities are suitable in light of the type and 
magnitude of impacts that the State or affected Indian Tribe may bear;
    (2) The proposed activities:
    (i) Will enhance communications between NRC and the State or 
affected Indian Tribe;
    (ii) Will make a productive and timely contribution to the review; 
and
    (iii) Are authorized by law.
    (e) The Director will advise the State or affected Indian Tribe 
whether its proposal has been accepted or denied, and if all or any 
part of proposal is denied, the Director shall state the reason for the 
denial.
    (f) Proposals submitted under this section, and responses thereto, 
shall be made available at the Public Document Room.


Sec. 63.64  Notice to State.

    If the Governor and legislature of the State of Nevada have jointly 
designated, on their behalf, a single person or entity to receive 
notice and information from the Commission under this part, the 
Commission will provide such notice and information to the jointly 
designated person or entity, instead of the Governor and legislature, 
separately.


Sec. 63.65  Representation.

    Any person who acts under this subpart as a representative for the 
State of Nevada (or for the Governor or legislature thereof) or for an 
affected Indian Tribe shall include in the request or other submission, 
or at the request of the Commission, a statement of the basis of his or 
her authority to act in such representative capacity.

Subpart D--Records, Reports, Tests, and Inspections


Sec. 63.71  Records and reports.

    (a) DOE shall maintain such records and make such reports in 
connection with the licensed activity as may be required by the 
conditions of the license or by rules, regulations, and orders of the 
Commission, as authorized by the Atomic Energy Act and the Energy 
Reorganization Act.
    (b) Records of the receipt, handling, and disposition of 
radioactive waste at a geologic repository operations area at the Yucca 
Mountain site shall contain sufficient information to provide a 
complete history of the movement of the waste from the shipper through 
all phases of storage and disposal. DOE shall retain these records in a 
manner that ensures their usability for future generations in 
accordance with Sec. 63.51(a)(2).


Sec. 63.72  Construction records.

    (a) DOE shall maintain records of construction of the geologic 
repository operations area at the Yucca Mountain site in a manner that 
ensures their usability for future generations in accordance with 
Sec. 63.51(a)(2).
    (b) The records required under paragraph (a) of this section shall 
include at least the following:
    (1) Surveys of the underground facility excavations, shafts, ramps, 
and boreholes referenced to readily identifiable surface features or 
monuments;
    (2) A description of the materials encountered;
    (3) Geologic maps and geologic cross-sections;
    (4) Locations and amount of seepage;
    (5) Details of equipment, methods, progress, and sequence of work;
    (6) Construction problems;
    (7) Anomalous conditions encountered;
    (8) Instrument locations, readings, and analysis;
    (9) Location and description of structural support systems;
    (10) Location and description of dewatering systems; and
    (11) Details, methods of emplacement, and location of seals used.


Sec. 63.73  Reports of deficiencies.

    (a) DOE shall promptly notify the Commission of each deficiency 
found in the characteristics of the Yucca Mountain site, and design and 
construction of the geologic repository operations area that, were it 
to remain uncorrected, could:
    (1) Be a substantial safety hazard;
    (2) Represent a significant deviation from the design criteria and 
design bases stated in the application; or
    (3) Represent a deviation from the conditions stated in the terms 
of a construction authorization or the license, including license 
specifications.
    (b) The notification shall be in the form of a written report, 
copies of which shall be sent to the Director and to the appropriate 
Nuclear Regulatory Commission Regional Office listed in Appendix D of 
Part 20 of this chapter.


Sec. 63.74  Tests.

    (a) DOE shall perform, or permit the Commission to perform, such 
tests as the Commission deems appropriate or necessary for the 
administration of the regulations in this part. These may include tests 
of:
    (1) Radioactive waste,
    (2) The geologic repository, including portions of the geologic 
setting and the structures, systems, and components constructed or 
placed therein,
    (3) Radiation detection and monitoring instruments, and
    (4) Other equipment and devices used in connection with the 
receipt, handling, or storage of radioactive waste.
    (b) The tests required under this section shall include a 
performance confirmation program carried out in accordance with Subpart 
F of this part.


Sec. 63.75  Inspections.

    (a) DOE shall allow the Commission to inspect the premises of the 
geologic repository operations area at the Yucca Mountain site and 
adjacent areas to which DOE has rights of access.
    (b) DOE shall make available to the Commission for inspection, on 
reasonable notice, records kept by DOE pertaining to activities under 
this part.
    (c)(1) DOE shall, on requests by the Director, Office of Nuclear 
Material Safety and Safeguards, provide rent-free office space for the 
exclusive use of the Commission inspection personnel. Heat, air-
conditioning, light, electrical outlets, and janitorial services shall 
be furnished by DOE. The office shall be convenient to and have full 
access to the facility and shall provide the inspector both visual and 
acoustic privacy.
    (2) The space provided shall be adequate to accommodate two full-
time inspectors, and other transient NRC personnel and will be 
generally commensurate with other office facilities at the Yucca 
Mountain site geologic repository operations area. A space of 250 
square feet either within the geologic repository operations area's 
office complex or in an office trailer or other onsite space at the 
geologic repository operations area is suggested as a guide. For 
locations at which activities are carried out under licenses issued 
under other parts of this chapter, additional space may be requested to 
accommodate additional full-time inspectors. The Office space that is 
provided shall be subject to the approval of the Director, Office of

[[Page 8674]]

Nuclear Material Safety and Safeguards. All furniture, supplies, and 
communication equipment will be furnished by the Commission.
    (3) DOE shall afford any NRC resident inspector assigned to the 
Yucca Mountain site or other NRC inspectors identified by the Regional 
Administrator as likely to inspect the Yucca Mountain facility, 
immediate unfettered access, equivalent to access provided regular 
employees, after proper identification and compliance with applicable 
access control measures for security, radiological protection, and 
personal safety.


Sec. 63.78  Material control and accounting records and reports.

    DOE shall implement a program of material control and accounting 
(and accidental criticality reporting) that is the same as that 
specified in Secs. 72.72, 72.74, 72.76, and 72.78 of this chapter.

Subpart E--Technical Criteria


Sec. 63.101  Purpose and nature of findings.

    (a)(1) Subpart B of this part prescribes the standards for issuance 
of a license to receive and possess source, special nuclear, or 
byproduct material at a geologic repository operations area at the 
Yucca Mountain site. In particular, Sec. 63.41(c) requires a finding 
that the issuance of a license will not constitute an unreasonable risk 
to the health and safety of the public. The purpose of this subpart is 
to set out the performance objectives and other criteria that, if 
satisfied, will support such a finding of no unreasonable risk.
    (2) Although the performance objective for the geologic repository 
after permanent closure specified at Sec. 63.113 is generally stated in 
unqualified terms, it is not expected that complete assurance that the 
requirement will be met can be presented. A reasonable assurance, on 
the basis of the record before the Commission, that the performance 
objective will be met is the general standard that is required. Proof 
that the geologic repository will be in conformance with the objective 
for postclosure performance is not to be had in the ordinary sense of 
the word because of the uncertainties inherent in the understanding of 
the evolution of the geologic setting, biosphere, and engineered 
barrier system. For such long-term performance, what is required is 
reasonable assurance, making allowance for the time period, hazards, 
and uncertainties involved, that the outcome will be in conformance 
with the objective for postclosure performance of the geologic 
repository. Demonstrating compliance will involve the use of complex 
predictive models that are supported by limited data from field and 
laboratory tests, site-specific monitoring, and natural analog studies 
that may be supplemented with prevalent expert judgment. Further, in 
reaching a determination of reasonable assurance, the Commission may 
supplement numerical analyses with qualitative judgments including, for 
example, consideration of the degree of diversity among the multiple 
barriers as a measure of the resiliency of the geologic repository.
    (b) Subpart B of this part also lists findings that must be made in 
support of an authorization to construct a geologic repository 
operations area at the Yucca Mountain site. In particular, 
Sec. 63.31(a) requires a finding that there is reasonable assurance 
that the types and amounts of radioactive materials described in the 
application can be received, possessed, and disposed of in a geologic 
repository operations area of the design proposed without unreasonable 
risk to the health and safety of the public. As stated in that 
paragraph, in arriving at this determination, the Commission will 
consider whether DOE has demonstrated that the geologic repository 
complies with the criteria contained in this subpart. Once again, 
although the criteria may be written in unqualified terms, the 
demonstration of compliance must take uncertainties and gaps in 
knowledge into account so that the Commission can make the specified 
finding with respect to reasonable assurance as specified in paragraph 
(a) of this section.


Sec. 63.102  Concepts.

    This section provides a functional overview of this Subpart E. In 
the event of any inconsistency with definitions found in Sec. 63.2, 
those definitions shall prevail.
    (a) The HLW facility at the Yucca Mountain site. NRC exercises 
licensing and related regulatory authority over those facilities 
described in Section 202 (3) and (4) of the Energy Reorganization Act 
of 1974, including the site at Yucca Mountain, as designated by the 
Energy Policy Act of 1992.
    (b) The geologic repository operations area. (1) This part deals 
with the exercise of authority with respect to a particular class of 
HLW facility--namely, a geologic repository operations area at Yucca 
Mountain.
    (2) A geologic repository operations area consists of those surface 
and subsurface areas of the site that are part of a geologic repository 
where radioactive waste handling activities are conducted. The 
underground structure, backfill materials, if any, and openings that 
penetrate the underground structure (e.g., ramps, shafts and boreholes, 
including their seals), are designated the underground facility.
    (3) The exercise of Commission authority requires that the geologic 
repository operations area be used for storage (which includes 
disposal) of high-level radioactive wastes (HLW).
    (4) HLW includes irradiated reactor fuel as well as reprocessing 
wastes. However, if DOE proposes to use the geologic repository 
operations area for storage of radioactive waste other than HLW, the 
storage of this radioactive waste is subject to the requirements of 
this part.
    (c) Stages in the licensing process. There are several stages in 
the licensing process. The site characterization stage, when the 
performance confirmation program is started, begins before submission 
of a license application, and may result in consequences requiring 
evaluation in the license review. The construction stage would follow, 
after issuance of a construction authorization. A period of operations 
follows the Commission's issuance of a license. The period of 
operations includes the time during which emplacement of wastes occurs; 
any subsequent period before permanent closure during which the 
emplaced wastes are retrievable; and permanent closure, which includes 
sealing openings to the repository. Permanent closure represents the 
end of the performance confirmation program; final backfilling of the 
underground facility, if appropriate; and the sealing of shafts, ramps, 
and boreholes.
    (d) Areas related to isolation. Although the activities subject to 
regulation under this part are those to be carried out at the geologic 
repository operations area, the licensing process also considers 
characteristics of adjacent areas that are defined in other ways. There 
must be an area surrounding the geologic repository operations area, 
that could include either a portion or all of the site, within which 
DOE must exercise specified controls to prevent adverse human actions 
after permanent closure. There is an area, designated the geologic 
setting, which includes the geologic, hydrologic, and geochemical 
systems of the region in which the site and geologic repository 
operations area are located. The geologic repository operations area, 
plus the portion of the geologic setting that provides isolation of the 
radioactive waste, make up the geologic repository.
    (e) Performance objectives through permanent closure. Before 
permanent closure, the geologic repository operations area is required 
to limit

[[Page 8675]]

radiation levels and exposures, in both restricted and unrestricted 
areas, and releases of radioactive materials to unrestricted areas, as 
specified at Sec. 63.111(a).
    (f) Integrated safety analysis. Section 63.111 includes performance 
objectives for the geologic repository operations area for the period 
before permanent closure and decontamination or dismantlement of 
surface facilities. The integrated safety analysis is a systematic 
examination of the geologic repository operations area's hazards and 
their potential for initiating event sequences; the potential event 
sequences and their consequences; and the site, structures, systems, 
components, equipment, and activities of personnel, to ensure that all 
relevant hazards that could result in unacceptable consequences have 
been adequately evaluated and appropriate protective measures have been 
identified. As used here, integrated means joint consideration of 
safety measures that otherwise might conflict, including, but not 
limited to, integration of fire protection, radiation safety, 
criticality safety, and chemical safety measures. The results of this 
analysis will support a determination regarding compliance of the 
geologic repository operations area with the requirements specified at 
Sec. 63.111.
    (g) Performance objective after permanent closure. After permanent 
closure, the geologic repository is required to limit the expected 
annual dose to the average member of the critical group, as specified 
at Sec. 63.113(b).
    (h) Multiple barriers. Section 63.113(a) requires that the geologic 
repository include multiple barriers, both natural and engineered. 
Geologic disposal of HLW is predicated on the expectation that a 
portion of the geologic setting will be capable of contributing to the 
isolation of radioactive waste, and thus be a barrier important to 
waste isolation. Although there is an extensive geologic record ranging 
from thousands to millions of years, this record is subject to 
interpretation and includes many uncertainties. In addition, there are 
uncertainties in the isolation capability and performance of engineered 
barriers. Although the composition and configuration of engineered 
structures (barriers) can be defined with a degree of precision not 
possible for natural barriers, it is recognized that except for a few 
archaeologic analogues, there is a limited experience base for the 
performance of complex, engineered structures over periods longer than 
a few hundred years considering the uncertainty in characterizing and 
modeling individual barriers. These uncertainties are addressed by 
requiring the use of a multiple barrier approach; specifically, an 
engineered barrier system is required in addition to the natural 
barriers provided by the geologic setting. It is intended that natural 
barriers and the engineered barrier system work in combination to 
enhance the resiliency of the geologic repository and increase 
confidence that the postclosure performance objective at Sec. 63.113(b) 
will be achieved.
    (i) Reference biosphere and critical group. The performance 
assessment will estimate the amount of radioactive material released to 
water or air at various locations and times in the future. To estimate 
the potential for future human exposures resulting from release of 
radioactive material from a geologic repository at Yucca Mountain, it 
is necessary to make certain assumptions about the location and 
characteristics of a critical group. The environment inhabited by the 
critical group, along with associated human exposure pathways and dose 
assessment parameters, make up the reference biosphere. The critical 
group is selected to represent those persons in the vicinity of Yucca 
Mountain who are reasonably expected to receive the greatest exposure 
to radioactive material released from a geologic repository at Yucca 
Mountain. Characteristics of the reference biosphere and the critical 
group are to be based on current human behavior and biospheric 
conditions in the region.
    (j) Performance assessment. Demonstrating compliance with the 
postclosure performance objective specified at Sec. 63.113(b) requires 
a performance assessment to quantitatively estimate the expected annual 
dose, over the compliance period, to the average member of the critical 
group. The performance assessment is a systematic analysis that 
identifies the features, events, and processes (i.e., specific 
conditions or attributes of the geologic setting, degradation, 
deterioration, or alteration processes of engineered barriers, and 
interactions between the natural and engineered barriers) that might 
affect performance of the geologic repository; examines their effects 
on performance; and estimates the expected annual dose. The features, 
events, and processes considered in the performance assessment should 
represent a wide range of both beneficial and potentially adverse 
effects on performance (e.g., beneficial effects of radionuclide 
sorption; potentially adverse effects of fracture flow or a criticality 
event). Those features, events, and processes expected to materially 
affect compliance with Sec. 63.113(b) or be potentially adverse to 
performance are included, while events of very low probability of 
occurrence (less than one chance in 10,000 over 10,000 years) can be 
excluded from the analysis. The expected annual dose to the average 
member of the critical group is estimated using the selected features, 
events, and processes, and incorporating the probability that the 
estimated dose will occur.
    (k) Institutional controls. Active and passive institutional 
controls will be maintained over the Yucca Mountain site, and are 
expected to reduce significantly, but not eliminate, the potential for 
human activity that could inadvertently cause or accelerate the release 
of radioactive material. Because it is not possible to make 
scientifically sound forecasts of the long-term reliability of such 
controls, however, it is not appropriate to integrate consideration of 
human intrusion into a fully risk-based performance assessment for 
purposes of evaluating the ability of the geologic repository to 
achieve the performance objective at Sec. 63.113(b). Hence, human 
intrusion is addressed in a stylized manner as described in paragraph l 
of this section.
    (l) Human intrusion. In contrast to events unrelated to human 
activity, the probability and characteristics of human intrusion 
occurring many hundreds or thousands of years into the future cannot be 
estimated by examining either the historic or geologic record. Rather 
than speculating on the nature and probability of future intrusion, it 
is more useful to assess how resilient the geologic repository would be 
against a postulated intrusion as specified at Sec. 63.113(d). Although 
the consequences of an assumed intrusion event is a separate analysis, 
the analysis is identical to the performance assessment required by 
Sec. 63.113(c); except that it assumes the occurrence of a postulated 
human intrusion event.
    (m) Performance confirmation. A performance confirmation program 
will be conducted to verify the assumptions, data, and analyses that 
support the performance assessment, and any findings, based thereon, 
that permitted construction of the repository. Key geologic, 
hydrologic, geomechanical, and other physical parameters will be 
monitored throughout site characterization, construction, emplacement, 
and operation to detect any significant changes in the conditions 
assumed in the performance assessment that may affect compliance with 
the performance objective at Sec. 63.113(b).

[[Page 8676]]

PERFORMANCE OBJECTIVES


Sec. 63.111  Performance objectives for the geologic repository 
operations area through permanent closure.

    (a) Protection against radiation exposures and releases of 
radioactive material.
    (1) The geologic repository operations area shall meet the 
requirements of Part 20 of this chapter.
    (2) During normal operations, and for Category 1 design basis 
events, the annual dose to any real member of the public, located 
beyond the boundary of the site shall not exceed a TEDE of 0.25 mSv (25 
mrem).
    (b) Numerical Guides for Design Objectives. (1) The geologic 
repository operations area shall be designed so that taking into 
consideration Category 1 design basis events and until permanent 
closure has been completed, radiation exposures and radiation levels in 
both restricted and unrestricted areas, and releases of radioactive 
materials to unrestricted areas, will be maintained within the limits 
specified in paragraph (a) of this section.
    (2) The geologic repository operations area shall be designed so 
that taking into consideration Category 2 design basis events and until 
permanent closure has been completed, no individual located on, or 
beyond, any point on the boundary of the site, will receive the more 
limiting of a TEDE of 0.05 Sv (5 rem), or the sum of the deep dose 
equivalent and the committed dose equivalent to any individual organ or 
tissue (other than the lens of the eye) of 0.5 Sv (50 rem). The lens 
dose equivalent shall not exceed 0.15 Sv (15 rem), and the shallow dose 
equivalent to skin shall not exceed 0.5 Sv (50 rem).
    (c) Integrated safety analysis. An integrated safety analysis of 
the geologic repository operations area that meets the requirements 
specified at Sec. 63.112 shall be performed. This analysis shall 
include a demonstration that:
    (1) The requirements of Sec. 63.111(a) will be met; and
    (2) The design meets the requirements of Sec. 63.111(b).
    (d) Performance confirmation. The geologic repository operations 
area shall be designed so as to permit implementation of a performance 
confirmation program that meets the requirements of Subpart F of this 
part.
    (e) Retrievability of waste. (1) The geologic repository operations 
area shall be designed to preserve the option of waste retrieval 
throughout the period during which wastes are being emplaced and 
thereafter, until the completion of a performance confirmation program 
and Commission review of the information obtained from such a program. 
To satisfy this objective, the geologic repository operations area 
shall be designed so that any or all of the emplaced waste could be 
retrieved on a reasonable schedule starting at any time up to 50 years 
after waste emplacement operations are initiated, unless a different 
time period is approved or specified by the Commission. This different 
time period may be established on a case-by-case basis consistent with 
the emplacement schedule and the planned performance confirmation 
program.
    (2) This requirement shall not preclude decisions by the Commission 
to allow backfilling part, or all of, or permanent closure of, the 
geologic repository operations area, before the end of the period of 
design for retrievability.
    (3) For purposes of this paragraph, a reasonable schedule for 
retrieval is one that would permit retrieval in about the same time as 
that required to construct the geologic repository operations area and 
emplace waste.
INTEGRATED SAFETY ANALYSIS


Sec. 63.112  Requirements for integrated safety analysis of the 
geologic repository operations area.

    The integrated safety analysis of the geologic repository 
operations area shall include:
    (a) A general description of the structures, systems, components, 
equipment, and process activities at the geologic repository operations 
area.
    (b) An identification and systematic analysis of naturally 
occurring and human-induced hazards at the geologic repository 
operations area, including a comprehensive identification of potential 
accident/event sequences that would result in unacceptable consequences 
(i.e., design basis events).
    (c) Data pertaining to the Yucca Mountain site, and the surrounding 
region to the extent necessary, used to identify naturally occurring 
and human-induced hazards at the geologic repository operations area.
    (d) The technical basis for either inclusion or exclusion of 
specific, naturally occurring and human-induced hazards in the safety 
analysis.
    (e) An analysis of the performance of the major design structures, 
systems, and components, both surface and subsurface, to identify those 
that are important to safety, including identification and description 
of controls that are relied on to limit or prevent potential accidents 
or mitigate their consequences, and including identification of 
measures taken to ensure the availability of identified safety systems. 
The analysis required in this paragraph shall include, but not 
necessarily be limited to, consideration of:
    (1) Means to limit concentration of radioactive material in air;
    (2) Means to limit the time required to perform work in the 
vicinity of radioactive materials;
    (3) Suitable shielding;
    (4) Means to monitor and control the dispersal of radioactive 
contamination;
    (5) Means to control access to high radiation areas or airborne 
radioactivity area;
    (6) Means to control criticality;
    (7) Radiation alarm system to warn of significant increases of 
radiation levels, concentrations of radioactive material in air, and 
increased radioactivity in effluents;
    (8) Ability of structures, systems, and components to perform their 
intended safety functions, assuming the occurrence of design basis 
events;
    (9) Explosion and fire detection systems and appropriate 
suppression systems;
    (10) Means to control radioactive waste and radioactive effluents, 
and permit prompt termination of operations and evacuation of personnel 
during an emergency;
    (11) Means to provide reliable and timely emergency power to 
instruments, utility service systems, and operating systems important 
to safety if there is a loss of primary electric power;
    (12) Means to provide redundant systems necessary to maintain, with 
adequate capacity, the ability of utility services important to safety; 
and
    (13) Means to inspect, test, and maintain structures, systems, and 
components important to safety, as necessary, to ensure their continued 
functioning and readiness.
    (f) A description and discussion of the design, both surface and 
subsurface, of the geologic repository operations area, including:
    (1) The relationship between principal design criteria and the 
requirements specified at Sec. 63.111(a) and (b); and
    (2) The design bases and their relation to the principal design 
criteria.


Sec. 63.113  Performance objective for the geologic repository after 
permanent closure.

    (a) The geologic repository shall include multiple barriers, 
consisting of both natural barriers and an engineered barrier system.
    (b) The engineered barrier system shall be designed so that, 
working in combination with natural barriers, the expected annual dose 
to the average

[[Page 8677]]

member of the critical group shall not exceed 0.25 mSv (25 mrem) TEDE 
at any time during the first 10,000 years after permanent closure, as a 
result of radioactive materials released from the geologic repository.
    (c) The ability of the geologic repository to limit radiological 
exposures to those specified in paragraph (b) of this section shall be 
demonstrated through a performance assessment that meets the 
requirements specified at Sec. 63.114, uses the reference biosphere and 
critical group specified at Sec. 63.115, and excludes the effects of 
human intrusion.
    (d) The ability of the geologic repository to limit radiological 
exposures to those specified in paragraph (b) of this section, in the 
event of limited human intrusion into the engineered barrier system, 
shall be demonstrated through a separate performance assessment that 
meets the requirements specified at Sec. 63.114 and uses the reference 
biosphere and critical group specified at Sec. 63.115. For the 
assessment required by this paragraph, it shall be assumed that the 
human intrusion occurs 100 years after permanent closure and takes the 
form of a drilling event that results in a single, nearly vertical 
borehole that penetrates a waste package, extends to the saturated 
zone, and is not adequately sealed.
PERFORMANCE ASSESSMENT


Sec. 63.114  Requirements for performance assessment.

    Any performance assessment used to demonstrate compliance with 
Sec. 63.113(b) shall:
    (a) Include data related to the geology, hydrology, and 
geochemistry (including disruptive processes and events) of the Yucca 
Mountain site, and the surrounding region to the extent necessary, and 
information on the design of the engineered barrier system, used to 
define parameters and conceptual models used in the assessment.
    (b) Account for uncertainties and variabilities in parameter values 
and provide the technical basis for parameter ranges, probability 
distributions, or bounding values used in the performance assessment.
    (c) Consider alternative conceptual models of features and 
processes that are consistent with available data and current 
scientific understanding, and evaluate the effects that alternative 
conceptual models have on the performance of the geologic repository.
    (d) Consider only events that have at least one chance in 10,000 of 
occurring over 10,000 years.
    (e) Provide the technical basis for either inclusion or exclusion 
of specific features, events, and processes of the geologic setting in 
the performance assessment. Specific features, events, and processes of 
the geologic setting must be evaluated in detail if the magnitude and 
time of the resulting expected annual dose would be significantly 
changed by their omission.
    (f) Provide the technical basis for either inclusion or exclusion 
of degradation, deterioration, or alteration processes of engineered 
barriers in the performance assessment, including those processes that 
would adversely affect the performance of natural barriers. 
Degradation, deterioration, or alteration processes of engineered 
barriers must be evaluated in detail if the magnitude and time of the 
resulting expected annual dose would be significantly changed by their 
omission.
    (g) Provide the technical basis for models used in the performance 
assessment such as comparisons made with outputs of detailed process-
level models and/or empirical observations (e.g., laboratory testing, 
field investigations, and natural analogs).
    (h) Identify those design features of the engineered barrier 
system, and natural features of the geologic setting, that are 
considered barriers important to waste isolation.
    (i) Describe the capability of barriers, identified as important to 
waste isolation, to isolate waste, taking into account uncertainties in 
characterizing and modeling the barriers.
    (j) Provide the technical basis for the description of the 
capability of barriers, identified as important to waste isolation, to 
isolate waste.
CHARACTERISTICS OF THE REFERENCE BIOSPHERE AND CRITICAL GROUP


Sec. 63.115  Required characteristics of the reference biosphere and 
critical group.

    (a) Reference biosphere. (1) Features, events, and processes that 
describe the reference biosphere shall be consistent with present 
knowledge of the conditions in the region surrounding the Yucca 
Mountain site.
    (2) Biosphere pathways shall be consistent with arid or semi-arid 
conditions.
    (3) Climate evolution shall be consistent with the geologic record 
of natural climate change in the region surrounding the Yucca Mountain 
site.
    (4) Evolution of the geologic setting shall be consistent with 
present knowledge of natural processes.
    (b) Critical group. (1) The critical group shall reside within a 
farming community located approximately 20 km south from the 
underground facility (in the general location of U.S. Route 95 and 
Nevada Route 373, near Lathrop Wells, Nevada).
    (2) The behaviors and characteristics of the farming community 
shall be consistent with current conditions of the region surrounding 
the Yucca Mountain site. Changes over time in the behaviors and 
characteristics of the critical group including, but not necessarily 
limited to, land use, lifestyle, diet, human physiology, or metabolics; 
shall not be considered.
    (3) The critical group resides within a farming community 
consisting of approximately 100 individuals, and exhibits behaviors or 
characteristics that will result in the highest expected annual doses.
    (4) The behaviors and characteristics of the average member of the 
critical group shall be based on the mean value of the critical group's 
variability range. The mean value shall not be unduly biased based on 
the extreme habits of a few individuals.
    (5) The average member of the critical group shall be an adult. 
Metabolic and physiological considerations shall be consistent with 
present knowledge of adults.
LAND OWNERSHIP AND CONTROL


Sec. 63.121  Requirements for ownership and control of interests in 
land.

    (a) Ownership of land. (1) Both the geologic repository operations 
area and the site shall be located in and on lands that are either 
acquired lands under the jurisdiction and control of DOE, or lands 
permanently withdrawn and reserved for its use.
    (2) These lands shall be held free and clear of all encumbrances, 
if significant, such as:
    (i) Rights arising under the general mining laws;
    (ii) Easements for right-of-way; and
    (iii) All other rights arising under lease, rights of entry, deed, 
patent, mortgage, appropriation, prescription, or otherwise.
    (b) Additional controls. Appropriate controls shall be established 
outside of the site. DOE shall exercise any jurisdiction and control 
over surface and subsurface estates necessary to prevent adverse human 
actions that could significantly reduce the geologic repository's 
ability to achieve isolation. The rights of DOE may take the form of 
appropriate possessory interests, servitudes, or withdrawals from 
location or patent under the general mining laws.
    (c) Water rights. (1) DOE shall also have obtained such water 
rights as may

[[Page 8678]]

be needed to accomplish the purpose of the geologic repository 
operations area.
    (2) Water rights are included in the additional controls to be 
established under paragraph (b) of this section.

Subpart F--Performance Confirmation Program


Sec. 63.131  General requirements.

    (a) The performance confirmation program shall provide data that 
indicate, where practicable, whether:
    (1) Actual subsurface conditions encountered and changes in those 
conditions during construction and waste emplacement operations are 
within the limits assumed in the licensing review; and
    (2) Geologic and engineered systems and components required for 
repository operation, and that are designed or assumed to operate as 
barriers after permanent closure, are functioning as intended and 
anticipated.
    (b) The program shall have been started during site 
characterization and it will continue until permanent closure.
    (c) The program shall include in-situ monitoring, laboratory and 
field testing, and in-situ experiments, as may be appropriate to 
provide the data required by paragraph (a) of this section.
    (d) The program shall be implemented so that:
    (1) It does not adversely affect the ability of the geologic and 
engineered elements of the geologic repository to meet the performance 
objectives.
    (2) It provides baseline information and analysis of that 
information on those parameters and natural processes pertaining to the 
geologic setting that may be changed by site characterization, 
construction, and operational activities.
    (3) It monitors and analyzes changes from the baseline condition of 
parameters that could affect the performance of a geologic repository.


Sec. 63.132  Confirmation of geotechnical and design parameters.

    (a) During repository construction and operation, a continuing 
program of surveillance, measurement, testing, and geologic mapping 
shall be conducted to ensure that geotechnical and design parameters 
are confirmed and to ensure that appropriate action is taken to inform 
the Commission of changes needed in design to accommodate actual field 
conditions encountered.
    (b) Subsurface conditions shall be monitored and evaluated against 
design assumptions.
    (c) As a minimum, measurements shall be made of rock deformations 
and displacement; changes in rock stress and strain; rate and location 
of water inflow into subsurface areas; changes in groundwater 
conditions; rock pore water pressures, including those along fractures 
and joints; and the thermal and thermomechanical response of the rock 
mass as a result of development and operations of the geologic 
repository.
    (d) These measurements and observations shall be compared with the 
original design bases and assumptions. If significant differences exist 
between the measurements and observations and the original design bases 
and assumptions, the need for modifications to the design or in 
construction methods shall be determined and these differences, their 
significance to repository performance, and the recommended changes 
reported to the Commission.
    (e) In-situ monitoring of the thermomechanical response of the 
underground facility shall be conducted until permanent closure, to 
ensure that the performance of the geologic and engineering features is 
within design limits.


Sec. 63.133  Design testing.

    (a) During the early or developmental stages of construction, a 
program for in-situ testing of such features as borehole and shaft 
seals, backfill, and the thermal interaction effects of the waste 
packages, backfill, rock, and groundwater shall be conducted.
    (b) The testing shall be initiated as early as practicable.
    (c) A backfill test section shall be constructed to test the 
effectiveness of backfill placement and compaction procedures against 
design requirements before permanent backfill placement is begun.
    (d) Test sections shall be established to test the effectiveness of 
borehole, shaft, and ramp seals before full-scale operation proceeds to 
seal boreholes, shafts, and ramps.


Sec. 63.134  Monitoring and testing waste packages.

    (a) A program shall be established at the geologic repository 
operations area for monitoring the condition of the waste packages. 
Waste packages chosen for the program shall be representative of those 
to be emplaced in the underground facility.
    (b) Consistent with safe operation at the geologic repository 
operations area, the environment of the waste packages selected for the 
waste package monitoring program shall be representative of the 
environment in which the wastes are to be emplaced.
    (c) The waste package monitoring program shall include laboratory 
experiments that focus on the internal condition of the waste packages. 
To the extent practical, the environment experienced by the emplaced 
waste packages within the underground facility during the waste package 
monitoring program shall be duplicated in the laboratory experiments.
    (d) The waste package monitoring program shall continue as long as 
practical up to the time of permanent closure.

Subpart G--Quality Assurance


Sec. 63.141  Scope.

    As used in this part, quality assurance comprises all those planned 
and systematic actions necessary to provide adequate confidence that 
the geologic repository and its subsystems or components will perform 
satisfactorily in service. Quality assurance includes quality control, 
which comprises those quality assurance actions related to the physical 
characteristics of a material, structure, component, or system that 
provide a means to control the quality of the material, structure, 
component, or system to predetermined requirements.


Sec. 63.142  Applicability.

    The quality assurance program applies to all systems, structures, 
and components important to safety, to design and characterization of 
barriers important to waste isolation, and to activities related 
thereto. These activities include: site characterization, facility and 
equipment construction, facility operation, performance confirmation, 
permanent closure, and decontamination and dismantling of surface 
facilities.


Sec. 63.143  Implementation.

    DOE shall implement a quality assurance program based on the 
criteria of Appendix B of 10 CFR Part 50, as applicable, and 
appropriately supplemented by additional criteria, as required by 
Sec. 63.142.

Subpart H--Training and Certification of Personnel


Sec. 63.151  General requirements.

    Operations of systems and components that have been identified as 
important to safety in the Safety Analysis Report and in the license 
shall be performed only by trained and certified personnel or by 
personnel under the direct visual supervision of an individual with 
training and certification in such operation. Supervisory personnel who 
direct operations that are important to safety must also be certified 
in such operations.

[[Page 8679]]

Sec. 63.152  Training and certification program.

    DOE shall establish a program for training, proficiency testing, 
certification, and requalification of operating and supervisory 
personnel.


Sec. 63.153  Physical requirements.

    The physical condition and the general health of personnel 
certified for operations that are important to safety shall not be such 
as might cause operational errors that could endanger the public health 
and safety. Any condition that might cause impaired judgment or motor 
coordination must be considered in the selection of personnel for 
activities that are important to safety. These conditions need not 
categorically disqualify a person, so long as appropriate provisions 
are made to accommodate such conditions.

Subpart I--Emergency Planning Criteria


Sec. 63.161  Emergency plan for the geologic repository operations area 
through permanent closure.

    DOE shall develop and be prepared to implement a plan to cope with 
radiological accidents that may occur at the geologic repository 
operations area, at any time before permanent closure and 
decontamination or dismantlement of surface facilities. The emergency 
plan shall be based on the criteria of Sec. 72.32(b) of this chapter.

Subpart J--Violations


Sec. 63.171  Violations.

    (a) The Commission may obtain an injunction or other court order to 
prevent a violation of the provisions of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974, as amended; 
or
    (3) A regulation or order issued pursuant to those Acts.
    (b) The Commission may obtain a court order for the payment of a 
civil penalty imposed under section 234 of the Atomic Energy Act:
    (1) For violations of--
    (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Atomic Energy Act of 1954, as amended;
    (ii) Section 206 of the Energy Reorganization Act;
    (iii) Any rule, regulation, or order issued pursuant to the 
sections specified in paragraph (b)(1)(i) of this section;
    (iv) Any term, condition, or limitation of any license issued under 
the sections specified in paragraph (b)(1)(i) of this section.
    (2) For any violation for which a license may be revoked under 
section 186 of the Atomic Energy Act of 1954, as amended.


Sec. 63.172  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
Sections 161b, 161i, or 161o of the Act. For purposes of Section 223, 
all the regulations in this Part 63 are issued under one or more of 
Sections 161b, 161i, or 161o, except for the sections listed in 
paragraph (b) of this section.
    (b) The regulations in this Part 63 that are not issued under 
Sections 161b, 161i, or 161o for the purposes of Section 223 are as 
follows: Sections 63.1, 63.2, 63.5, 63.6, 63.7, 63.8, 63.15, 63.16, 
63.21, 63.22, 63.23, 63.24, 63.31, 63.32, 63.33, 63.41, 63.42, 63.43, 
63.45, 63.46, 63.51, 63.52, 63.61, 63.62, 63.63, 63.64, 63.65, 63.101, 
63.102, 63.111, 63.112, 63.113, 63.114, 63.115, 63.121, 63.131, 63.132, 
63.133, 63.134, 63.141, 63.142, 63.153, 63.171, and 63.172.

    Dated at Rockville, Maryland, this 12th day of February, 1999.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 99-4022 Filed 2-19-99; 8:45 am]
BILLING CODE 7590-01-P