[Federal Register Volume 66, Number 213 (Friday, November 2, 2001)]
[Rules and Regulations]
[Pages 55732-55816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27157]



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Part II





Nuclear Regulatory Commission





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10 CFR Parts 2, 19, 20, 21, etc.



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

  Federal Register / Vol. 66, No. 213 / Friday, November 2, 2001 / 
Rules and Regulations  

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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 2, 19, 20, 21, 30, 40, 51, 60, 61, 63, 70, 72, 73, and 
75

RIN 3150-AG04


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

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing 
licensing criteria for disposal of spent nuclear fuel and high-level 
radioactive wastes in the proposed geologic repository at Yucca 
Mountain, Nevada. As mandated by law, this final rule changes the 
Commission's technical requirements and criteria, as necessary, to be 
consistent with final environmental standards for Yucca Mountain issued 
by the U.S. Environmental Protection Agency (EPA). The criteria address 
how a repository system at Yucca Mountain must perform and specify that 
the system must comprise both natural and engineered barriers. The 
final rule includes licensing criteria; participation in license 
reviews by the State, affected units of local government, and Indian 
Tribes; records and reporting; monitoring and testing programs; 
performance confirmation; quality assurance; personnel training and 
certification; and emergency planning. Criteria set out in this final 
rule apply specifically and exclusively to the proposed repository at 
Yucca Mountain. Consistent with this intent, the Commission is also 
changing its generic criteria for disposal of spent nuclear fuel and 
high-level radioactive wastes in geologic repositories. These changes 
make clear that the generic criteria, specified elsewhere in the 
regulations, do not apply, nor may they be the subject of litigation, 
in any NRC licensing proceeding for a repository at Yucca Mountain.

EFFECTIVE DATE: December 3, 2001.

FOR FURTHER INFORMATION CONTACT: Timothy McCartin, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-7285, e-mail 
[email protected]; Janet Kotra, Office of Nuclear Material Safety and 
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone (301) 415-6674, 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. Implementation of the Environmental Protection Agency Final 
Standards.
III. Public Comments and Responses.
    1. Regulatory Process and Licensing Process.
    1.1. Promulgation in Advance of EPA Standards.
    1.2. Differences Between Part 63 and EPA Standards for WIPP.
    1.3. Multi-Staged Licensing.
    1.4. Reasonable Assurance.
    2. Requirements for the Preclosure Period.
    2.1. Preclosure Safety Analysis.
    2.2. Retrievability.
    2.3. Performance Confirmation.
    2.4. Preclosure Operations Activities.
    2.5. Emergency Planning Criteria.
    3. Requirements for the Postclosure Period.
    3.1. Postclosure Safety Assessment.
    3.2. Individual Dose Limit.
    3.3 Calculation of Expected Dose.
    3.4. Infant and Children Dose Standard.
    3.5. Location of the Critical Group or RMEI.
    3.6. Critical Group Characteristics and Reference Biosphere.
    3.7. Absence of Separate Ground-Water Protection Criteria.
    3.8. Multiple Barriers and Defense in Depth.
    3.9. Compliance Period.
    3.10. Human Intrusion Standard.
    3.11. Postclosure Aspects of Repository Design.
    4. General Requirements.
    4.1. Quality Assurance.
    4.2. Changes, Tests, and Experiments.
    4.3. Land Ownership and Control.
    5. Selected Topics.
    5.1. Public Out-Reach.
    5.2. Other Comments.
    6. Beyond the Scope of This Rulemaking.
    6.1. Hearing Process.
    6.2. Transportation.
    6.3. Other Comments.
IV. Changes From the Proposed Rule.
V. Section-by-Section Analysis of Part 63.
VI. Section-by-Section Analysis of Corresponding Changes to Other 
Parts.
VII. Voluntary Consensus Standards.
VIII. Finding of No Significant Environmental Impact: Availability.
IX. Paperwork Reduction Act Statement.
X. Regulatory Analysis.
XI. Regulatory Flexibility Certification.
XII. Backfit Analysis.
XIII. Small Business Regulatory Enforcement Fairness Act.

I. Background

    On February 22, 1999 (64 FR 8640), the Commission published a 
proposed rule for public comment that would establish licensing 
criteria for disposal of spent nuclear fuel and high-level radioactive 
waste in the proposed geologic repository at Yucca Mountain, Nevada. 
The Energy Policy Act of 1992, Pub. L. 102-486 (EnPA) directed the 
Commission to make its requirements for geologic disposal consistent 
with new standards for Yucca Mountain the Environmental Protection 
Agency (EPA) would develop. The legislation also specifies the type of 
standards the NRC is to implement [that is, standards which limit 
individual dose and which are based on and consistent with the National 
Academy of Sciences' (NAS) 10 recommendations]. The Commission proposed 
a new, separate part of its regulations, 10 CFR part 63, that would 
apply only to the proposed repository at Yucca Mountain. The Commission 
also proposed to leave its existing, generic regulations at Part 60 in 
place, changed only to state that they do not apply, nor may they be 
the subject of litigation, in any NRC licensing proceeding for a 
repository at Yucca Mountain.
    In setting forth these criteria, the Commission sought to establish 
a coherent body of risk-informed, performance-based criteria for a 
Yucca Mountain facility 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, and 
performance history are used to (1) focus attention on the most 
important activities, (2) establish objective criteria based upon risk 
insights for evaluating performance, (3) develop measurable or 
calculable parameters for monitoring system and licensee performance, 
and (4) focus on the results as the primary basis for regulatory 
decision making. The Commission believes that creating a new part of 
its regulations accomplishes these objectives better than modifying the 
generic requirements. The Commission prefers a wholly new part 63 that 
reflects the fundamentally different approach laid out for Yucca 
Mountain by EnPA and the final EPA standards, an approach unlike that 
contemplated when the generic criteria were issued. Specifically, EnPA 
defined an approach that requires the performance of a Yucca Mountain 
repository to comply with health-based standards, developed by EPA and 
based on the recommendations of the NAS. EPA has established standards 
for Yucca Mountain that consider risk to a hypothetical individual and 
are to be the only such standards for the postclosure performance of 
the repository. This approach differs from that taken in the existing 
generic criteria which relies on quantitative, subsystem performance 
standards.
    The public comment period, originally ending on May 10, 1999, was

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extended to June 30, 1999, in response to many requests for extension 
(64 FR 24092; May 5, 1999). During the public comment period, the NRC 
staff held a series of public meetings in Nevada to discuss the 
proposed rule and solicit public comment. Meetings were held at Las 
Vegas and Beatty, Nevada, on March 23 and 25, respectively. Later, NRC 
held more meetings at Amargosa Valley, Las Vegas, and Caliente, Nevada, 
on June 15, 16, and 17, respectively. In developing this final rule, 
NRC considered comments received at these meetings along with written 
comments sent to NRC. The NRC also held a facilitated round table 
discussion on defense in depth as applied to a possible repository at 
Yucca Mountain on November 2, 1999, in Las Vegas.
    The EPA published final radiation protection standards for the 
potential Yucca Mountain repository (40 CFR part 197) on June 13, 2001 
(66 FR 32073). The EPA standards differ from the performance objectives 
proposed by the Commission at 10 CFR part 63. EPA established an annual 
individual protection dose limit of 0.15 mSv (15 mrem), and EPA 
included separate ground-water protection criteria in its final 
standards for the purpose of protecting ground water. In formal 
comments on EPA's proposed standards, dated November 3, 1999, the NRC 
staff supported a somewhat different approach. The NRC approach, which 
the Commission believes is adequately protective of public health and 
safety and ground water, used a comprehensive, all-pathway limit. 
However, the ultimate decision was EPA's to make and, as called for 
under the EnPA, the Commission will change its technical requirements 
and criteria to be consistent with EPA's final standards.

II. Implementation of the Environmental Protection Agency Final 
Standards

    The U.S. Environmental Protection Agency (EPA) published Public 
Health and Environmental Radiation Protection Standards for Yucca 
Mountain, Nevada, at 40 CFR part 197 on June 13, 2001 (66 FR 32073). 
The Energy Policy Act of 1992, Pub. L. 102-486 (EnPA) directs the 
Commission to modify its technical requirements and criteria to be 
consistent with these standards. The Commission has imported the EPA 
standards into its final 10 CFR part 63 regulations in as transparent a 
manner as possible. Three categories of changes were necessary to 
accomplish this. First, the two subparts of the EPA standards--subpart 
A for storage and subpart B for disposal--have been added to part 63 as 
subparts K and L, respectively. Second, in most cases, the Commission 
adopted wording precisely as it appears at 40 CFR part 197. The 
Commission also made nonsubstantive changes that conformed to the 
regulatory style of the proposed part 63, and other U.S. Nuclear 
Regulatory Commission (NRC) regulations; removed unnecessary references 
to NRC; and adapted or removed redundant definitions. Lastly, as the 
implementing authority for the EPA standards, we have provided 
additional specifications and requirements based on the proposed part 
63 rule and public comments we received in the areas where it is 
appropriate to do so. Indeed, EPA has acknowledged NRC's authority to 
add implementing requirements. As part of its rulemaking process, the 
Commission proposed and received comments on many aspects of radiation 
exposure scenarios, including several matters relevant to 
implementation of the EPA standards. Although EPA publication of the 
standards postdated the formal comment period for proposed part 63, the 
Commission has provided further specifications in subpart L, where 
needed, for clarification. We believe these additions are consistent 
with EPA's intent and are responsive to public comments we received. A 
brief summary of key aspects of the Commission's implementation of 
EPA's Standards in the final part 63 regulations appears below.

Radiation Standards for Storage

    NRC has adopted the 0.15 mSv/year (15 mrem/year) dose limit for 
members of the public, during the storage period, and the associated 
requirements for determining compliance with the standards. The EPA 
standards identify the standards for storage as applicable at Yucca 
Mountain during the time period before closure of the proposed 
repository. In proposed part 63, NRC characterized this phase as 
``preclosure.'' Therefore, we are implementing EPA's standards for 
storage to apply to the preclosure time period.

Radiation Standards for Disposal

    The NRC has adopted the 0.15 mSv/year (15 mrem/year) dose limit for 
the reasonably maximally exposed individual, during the disposal 
period, and the associated requirements for determining compliance with 
the standards.

Ground-Water Protection Standards

    NRC has adopted the ground-water protection standards and the 
associated requirements for determining compliance with the standards.

Radiation Standards for Human Intrusion

    NRC has adopted the 0.15 mSv/year (15 mrem/year) dose limit for the 
reasonably maximally exposed individual as a result of a human 
intrusion and the associated requirements for determining compliance 
with the standards. One aspect of EPA's final standards is the 
specification of the characteristics of a postulated scenario for 
evaluating the consequences of human intrusion. NRC fully supports and 
has adopted the characteristics of the human intrusion scenario as 
specified in 40 CFR part 197 and has specified one additional 
requirement to further characterize the scenario. Specifically, part 63 
provides that no particulate waste material falls into the borehole, 
and that DOE should assume the exposure scenario includes only those 
radionuclides transported to the saturated zone by water (e.g., water 
enters the waste package, releases radionuclides, and transports 
radionuclides by way of the borehole to the saturated zone). This 
change responds to a public comment seeking clarification of this 
aspect of the human intrusion scenario in proposed part 63. The 
Commission considers the additional requirement to be appropriate for 
addressing the comment and to be a matter of implementation of the EPA 
final standards. Further, the requirement is consistent with the human 
intrusion scenario as specified in 40 CFR part 197.

Reference Biosphere

    The EPA standards for Yucca Mountain specify criteria that pertain 
to the characteristics of a reference biosphere, for use in the 
performance assessments that are required to show compliance with the 
postclosure standards for disposal. NRC fully supports and has adopted, 
in part 63, the characteristics of the reference biosphere as specified 
in 40 CFR part 197 and has included an additional requirement on 
characteristics of the biosphere that are consistent with EPA's final 
standards and that were discussed in proposed part 63 (64 FR 8640; 
February 22, 1999). Specifically, part 63 provides a further 
requirement for biosphere pathways by stating these pathways * * * 
``must be consistent with arid and semi-arid conditions.'' This 
addition, from proposed part 63 (64 FR 8677), clarifies the bounds on 
what DOE needs to consider and is consistent with present knowledge of

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how the climate could change over the next 10,000 years.

Reasonably Maximally Exposed Individual

    The EPA standards specify characteristics of the reasonably 
maximally exposed individual (RMEI) for use in the performance 
assessments used to demonstrate compliance with standards for disposal. 
The NRC fully supports and has adopted the characteristics of the 
reasonably maximally exposed individual from 40 CFR part 197, and has 
included requirements specifying additional characteristics that are 
consistent with the EPA standards and were discussed in proposed part 
63 (64 FR 8640). First, part 63 provides that the reasonably maximally 
exposed individual * * * ``is an adult with metabolic and physiological 
considerations consistent with present knowledge of adults.'' This 
addition, suggested for the average member of the critical group in 
proposed part 63 (64 FR 8677), clarifies assumptions DOE must make in 
estimating the radiation exposure to the reasonably maximally exposed 
individual. This addition is considered to be consistent with EPA's 
standards because: (1) The standards specify a consumption rate for 
water (i.e., 2 liters per day) that corresponds with that of an adult; 
and (2) a dose limit of 0.15 mSv (15 mrem) for an adult is protective 
of children as well as other age groups. The requirement that metabolic 
and physiological considerations are consistent with present knowledge 
of adults is consistent with EPA's final standards, which state that 
DOE should not project changes in human biology (66 FR 32133).
    Second, although the EPA standards specify a representative volume 
approach for demonstrating compliance with the separate ground-water 
protection standards, they leave to NRC the approach for demonstrating 
compliance with the individual protection standard for disposal. EPA's 
approach for ground-water protection specifies a representative volume 
of 3,000 acre-feet for estimating the concentrations of radionuclides. 
The 3,000 acre-feet representative volume of ground water is consistent 
with assumptions for the critical group described in proposed part 63 
(64 FR 8646). Specifically, in the proposed part 63, we suggested 
consideration of a farming community of up to 100 individuals, living 
on 15 to 25 farms. Fifteen to 25 farms are consistent with current 
conditions in the town of Amargosa Valley, Nevada, and would be the 
number needed to produce the range of locally produced food that is 
currently consumed in this area. The purpose of identifying 15 to 25 
farms and specifying 100 individuals was to provide DOE with 
flexibility in determining an appropriate water demand consistent with 
a farming community of that size. A community of 15 to 25 farms would 
pump a sufficiently large volume of water and involve a broad range of 
exposure pathways. Of primary importance is the ingestion pathway, 
through consumption of water, crops, and animal products. The 
Commission considers that the water demand of between 15 and 25 farms 
can be represented by a volume of at least 3,000 acre-feet and, thus, 
is consistent with the farming community proposed for comment in part 
63. Additionally, the preamble to EPA's final standards stated the NRC 
could use an approach to assess water usage in the hypothetical 
community, in which the RMEI resides, that was similar to the 
representative volume approach used for ground-water protection (i.e., 
consider a representative volume of 3,000 acre-feet). Therefore, the 
Commission removed the flexibility provided DOE to determine an 
appropriate water demand. This revised approach limits speculation on 
water demand and provides DOE with a specific value for the water 
demand that the NRC staff finds acceptable to estimate the RMEI dose. 
Part 63 specifies that the reasonably maximally exposed individual uses 
well water with an average concentration of radionuclides based on a 
representative volume of water of 3,000 acre-feet.

Unlikely Features, Events, and Processes

    The EPA standards exclude unlikely features, events, and processes 
(including sequences of events and processes) from analyses for 
estimating compliance with the standards for human intrusion and 
ground-water protection. However, the EPA standards do not specify a 
frequency for unlikely features, events, and processes, and acknowledge 
that a value is to be specified by NRC (66 FR 32135). NRC fully 
supports excluding unlikely features, events, and processes from 
analyses for estimating compliance with the standards for human 
intrusion and ground-water protection. Although we have provided no 
specific quantitative value for determining when exclusion of unlikely 
features, events, and processes is appropriate, the final regulations 
require DOE to exclude unlikely features, events, and processes from 
the specified analyses upon prior approval of the Commission for the 
probability limit used for unlikely features, events, and processes. 
The Commission recognizes that specification of a probability limit for 
unlikely features, events, and processes, as is done for ``very'' 
unlikely features, events, and processes, would be a more direct 
approach. Although the Commission considers a frequency for unlikely 
features, events, and processes would fall somewhere between 
10-8 to 10-4 per year, the Commission has decided 
not to specify a value in the regulations at this time. The Commission 
plans to conduct an expedited rulemaking to quantitatively define the 
term ``unlikely.'' Consideration will be given to whether a range of 
values or a single specific value should be used as well as the 
appropriate numerical value(s). The expedited rulemaking will provide 
an opportunity for public comment to assist the Commission in 
determining an appropriate approach.

Total Effective Dose Equivalent

    The EPA and the NRC use different quantities to assess the total 
dose to exposed members of the public (including the RMEI). EPA uses 
the annual committed effective dose equivalent (annual CEDE), defined 
as the sum of the committed effective dose equivalent from internal 
doses resulting from one year's exposure to radioactive materials, and 
the effective dose equivalent from external radiation exposure during 
the year. The NRC uses the total effective dose equivalent (TEDE) for 
the same purpose. There are differences between TEDE and annual CEDE in 
some contexts. Specifically, in determining the external dose component 
of TEDE, NRC specifies use of the deep-dose equivalent at 10 CFR 
20.1003. The deep-dose equivalent is a point measurement that does not 
sum the doses to the organs or tissue through use of weighting factors. 
This approach may reflect the fact that compliance with part 20 is 
customarily assessed using a Thermo-Luminiscent Device (TLD) or a film 
badge, and the results of such measurements reflect deep-dose 
equivalent. By contrast, in determining annual CEDE, the external dose 
component is determined using the effective dose equivalent, which 
involves summing the products of organ doses and weighting factors. In 
those situations in which the two measures of external dose differ, the 
effective dose equivalent approach probably provides a better estimate 
for measuring radiation risk.
    Nonetheless, NRC's part 20 does allow for consideration of 
weighting factors for individual organs in the case of external 
exposures on a case-by-case

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basis. See 10 CFR 20.1003, Footnote 2 to Table on Organ Dose Weighting 
Factors. In practice, computer codes used by NRC in decommissioning and 
HLW disposal currently calculate external doses using effective dose 
equivalent and not deep-dose equivalent. See NUREG/CR 6676, 
``Probabilistic Dose Analysis Using Parameter Distributions Developed 
for RESRAD and RESRAD-Build Codes,'' 3-1 (July 2000); NUREG-1464, ``NRC 
Iterative Performance Assessment,'' 7-5 (October 1995); and NUREG/CR-
5512, ``Residual Contamination from Decommissioning, User's Manual 
DandD Version 2.1,'' Vol. 2, E-1 (April 2001). Consequently, use of 
organ doses and organ weighting factors, from Federal Guidance Report 
12 and ICRP in its Publication 26, for external doses in assessing 
compliance with dose limits for members of the public in the general 
environment and the individual protection standard in connection with a 
geologic repository will yield exactly the same result as applying 
annual CEDE. As a result, in assessing compliance with the individual 
protection standard, the staff intends to use effective dose equivalent 
for assessing external exposure.
    For purposes of assessing actual doses to workers at the Yucca 
Mountain repository, however, the Commission has directed that deep-
dose equivalent be used in determining TEDE. This ensures consistency 
with NRC's regulations for limiting doses to occupationally exposed 
workers.

Requirements for Environmental Impact Statement

    EPA's standards require DOE to estimate peak dose under the 
evaluations for individual protection and human intrusion. The results 
of these evaluations are to be included in DOE's environmental impact 
statement (EIS). The Commission has modified part 63 to include the 
provision that DOE must include peak dose estimates in its EIS, but 
notes that there is no standard that must be met with respect to these 
peak dose calculations, and that there is no finding that the NRC must 
make with respect to these peak dose calculations nor may they be the 
subject of litigation in any NRC licensing proceedings for a repository 
at Yucca Mountain. However, DOE still must carry out its 
responsibilities under the National Environmental Policy Act in 
accordance with the final EPA standards.

Definitions

Barriers
    Proposed part 63 and EPA's final standards define ``barriers'' 
slightly differently. The Commission believes there is no substantive 
difference between the two definitions and has adopted the EPA 
definition at Sec. 63.2. The EPA definition, among other things, 
provides that the Commission would determine a time period over which a 
material, structure or feature would perform its intended function. The 
regulation at Sec. 63.115 requires DOE to describe the capability of 
each barrier to isolate waste. The description would include 
information on the time period over which DOE asserts that each barrier 
will perform its intended function including any changes during the 
compliance period. This information on expected performance will enable 
NRC to determine the period of time that any particular material, 
structure or feature prevents or substantially reduces the rate of 
movement of water or radionuclides from the Yucca Mountain repository 
to the accessible environment, or prevents the release or substantially 
reduces the release rate of radionuclides from the waste.
Ground Water
    Proposed part 63 and EPA's final standards define ``ground water'' 
differently. To implement the EPA standard, part 63 has adopted the EPA 
definition for ground water and revised the use of the term ``ground 
water'' in the proposed rule accordingly. The single definition for 
ground water is provided at Sec. 63.302.
High-Level Waste
    Proposed part 63 and EPA's final standards define ``high-level 
waste'' slightly differently. The Commission believes there is no 
substantive difference between the two definitions and has modified its 
definition to more closely reflect the definition provided in the 
Nuclear Waste Policy Act of 1982 and the final standards.
Important to Waste Isolation
    Proposed part 63 defined ``important to waste isolation'' in the 
context of meeting the individual dose limit for the postclosure period 
of the repository (i.e., disposal). This use of the term is important 
in defining the scope of the requirements for: DOE's quality assurance 
program (specified at subpart G); multiple barriers (specified at 10 
CFR 63.113); performance confirmation (specified at subpart F); and 
changes, tests, and experiments (specified at 10 CFR 63.44). The 
Commission has expanded the definition of the term, ``important to 
waste isolation'' to include both the dose limit and the separate 
ground-water protection limits contained in the EPA standards.
Performance Assessment
    Proposed part 63 and EPA's final standards define ``performance 
assessment'' slightly differently. The Commission believes there is 
nosubstantive difference between the two definitions and has adopted 
the EPA definition at Sec. 63.2.

III. Public Comments and Responses

    In preparing the final rule, the NRC staff carefully reviewed and 
considered more than 700 discrete comments enclosed in about 160 
individual letters received during the public comment period. The NRC 
staff also identified and evaluated an additional 193 comments made at 
public meetings. To simplify the analysis, the NRC staff grouped all 
written and oral comments on the rule into the following six major 
topic areas:
    (1) Regulatory Process and Licensing Process;
    (2) Requirements for the Preclosure Period;
    (3) Requirements for the Postclosure Period;
    (4) General Requirements;
    (5) Selected Topics; and
    (6) Beyond the Scope of This Rulemaking.

1  Regulatory Process and Licensing Process

1.1  Promulgation in Advance of EPA Standards

    Issue 1: Is NRC's action in promulgating part 63 in advance of EPA 
standards beyond the scope of its authority?
    Comment. Many of those who commented on the NRC's proposed part 63 
expressed concern that NRC was ``usurping'' EPA's authority by 
declaring its own standards and technical requirements in advance of 
EPA's issuance of final standards. For example, the State of Nevada 
pointed out the EnPA does not mandate a new Commission rule specific to 
Yucca Mountain to replace its general rule for licensing geologic 
repositories. It only requires modification of NRC's technical 
requirements and criteria, as necessary, to be consistent with new EPA 
standards once they are published. Further, the State pointed out that 
EnPA does not authorize the Commission to expand its licensing 
jurisdiction to include proposing standards for human safety and 
environmental protection

[[Page 55736]]

that are within the statutory mandate and jurisdiction of EPA.
    Response. The Commission acknowledges the statutory role given to 
EPA for setting standards for Yucca Mountain. It is with full 
recognition of that role that the Commission is publishing final 
criteria that are consistent with EPA's published standards. In the 
supplementary information published with the proposed rule, the 
Commission stated clearly that ``* * * the authority and responsibility 
for setting public health and safety standards for radioactive waste 
disposal rest with EPA'' (64 FR 8643; February 22, 1999). The 
Commission went on to say that ``* * * [w]hen 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'' (ibid. 8644).
    It is true the EnPA did not direct the NRC to develop a new rule 
specific to Yucca Mountain to replace its general rule for licensing 
geologic repositories. It is also true the EnPA does not diminish NRC's 
authority under the Atomic Energy Act to conduct rulemaking nor to 
select the manner in which it will revise regulatory requirements. In 
the proposed rule, the Commission explained that since the initial 
technical criteria at 10 CFR part 60 were promulgated more than 15 
years ago, there has been notable evolution in the capability of 
technical methods for assessing the performance of a geologic 
repository at Yucca Mountain. The Commission stated that ``(t)hese 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'' (64 FR 8641). The Commission 
recognized that its generic part 60 requirements will need updating if 
applied to sites other than Yucca Mountain. However, the Commission 
elected not to conduct an update of part 60 now but, instead, decided 
to place all the regulations needed for the licensing of a repository 
at Yucca Mountain in a separate CFR part. See Response to Issue 3. The 
Commission explained that it ``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'' (64 FR 8643). Consistent with the views 
expressed by most commenters, the Commission has awaited EPA's 
publication of final standards for Yucca Mountain and has changed its 
technical requirements and criteria to conform to EPA's standards, as 
required by law.
    Issue 2: Should NRC wait for EPA to release final standards before 
completing part 63?
    Comment. Commenters differed on the issue whether NRC should 
proceed with proposed part 63 or wait until after EPA publishes final 
standards. Commenters in favor of NRC moving forward with the proposed 
part 63 supported the proposed approach as protective of public health 
and safety and the environment. They cited timely specification of NRC 
regulations for the potential repository as a benefit for the national 
program. Others, however, believed that it was premature for NRC to 
publish final regulations. They felt that doing so would be contrary to 
the sequence set by Congress in the EnPA which directs EPA to issue 
radiation standards first and then for NRC to conform its technical 
requirements to those standards. These commenters saw no reason for NRC 
to act outside this time sequence and favored withdrawal of the 
proposed rule and resubmittal with any necessary adjustments after 
promulgation of EPA standards.
    Response. The EnPA specified that EPA was to publish radiation 
standards for Yucca Mountain not later than 1 year after receipt of the 
findings and recommendations of the National Academy of Sciences (NAS). 
It also directed NRC to modify its technical requirements and criteria 
not later than 1 year after EPA publishes final standards. The 
Commission believes that this schedule reflects Congress' intent to 
have a final regulatory structure before DOE would start preparation of 
a license application if Yucca Mountain were recommended as a site for 
a geologic repository. The NAS published its recommendations in August 
1995. The NRC explained when it published its proposed rule, on 
February 22, 1999, that it had decided to proceed, even in the absence 
of EPA standards, because of the short time period allotted NRC to 
conduct its own rulemaking. In one year, NRC would have to modify its 
standards and requirements and to implement certain assumptions in the 
EnPA related to the effectiveness of postclosure oversight of the 
repository. The Commission also believed it was in the best interest of 
the national program to proceed, given that DOE could be in a position 
to submit a license application to NRC in 2002 (64 FR 8641). It is 
important to recognize that most of the requirements proposed at part 
63 involve matters that are unaffected by the final EPA standards 
(e.g., licensing procedures, records and reporting, monitoring and 
testing programs, performance confirmation, quality assurance, 
personnel training and certification, and emergency planning). Now that 
EPA has published final standards, NRC is prepared to complete its 
implementing regulations at part 63 with due regard to the requirement 
in EnPA to be consistent with EPA's standards.
    Issue 3: Why is there a need to develop a site-specific disposal 
regulation for the Yucca Mountain site?
    Comment. Several commenters questioned NRC's need to develop a 
whole new body of site-specific regulations as opposed to revising its 
generic regulations at part 60, as necessary, to conform to the new, 
site-specific standards to be developed by EPA. These same commenters 
noted that certain portions of proposed part 63 depart significantly 
from part 60 (e.g., there are no quantitative subsystem requirements) 
and, in the view of several commenters, weaken the safety requirements 
for any proposed repository at Yucca Mountain.
    Response. The Commission is establishing a new, separate part of 
its regulations (at part 63) that would apply only to the proposed 
repository at Yucca Mountain. The Commission will leave existing, 
generic regulations at part 60 in place, modified only to state 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 efficient approach 
for specifying concise, site-specific criteria for Yucca Mountain that 
are consistent with current assumptions, with site-specific information 
and performance assessment experience, and with EPA standards that 
apply solely to Yucca Mountain.
    In developing these criteria, the Commission sought 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 [``Use of Probabilistic 
Risk Assessment Methods in Nuclear Regulatory Activities--Final Policy 
Statement'' (60 FR 42622; August 16, 1995)]. Stated succinctly, risk-
informed, performance-based regulation is an

[[Page 55737]]

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 
creating a new part of its regulations to accomplish these objectives 
is preferable to modifying its generic requirements, given that EnPA 
and NAS laid out a fundamentally different approach for Yucca Mountain 
than was contemplated when the generic criteria were promulgated. 
Specifically, EnPA and NAS outlined an approach that would require the 
performance of a Yucca Mountain repository to comply with health-based 
standards established in consideration of risk to individuals in a 
hypothetical group. The law also stated that the new health-based 
standards were to be the only quantitative standards for the 
postclosure performance of the repository. This approach departs from 
the approach taken in the existing generic criteria which rely on 
compliance with cumulative release limits and separate, quantitative, 
subsystem performance objectives. Further, the Commission's current 
approach is consistent with EPA standards for Yucca Mountain. 
Therefore, after carefully considering the public comments, the 
Commission remains of the view that it is best to develop site-specific 
regulations--regulations that reflect an improved scientific 
understanding of the site; are based on state-of-the-art analyses; are 
consistent with the Commission's philosophy to implement risk informed 
regulation; and implement the separate, site-specific standards that 
EPA has issued for Yucca Mountain.
    Commenters correctly pointed out that there are significant 
differences between part 60 and part 63. In the Commission's view, the 
part 63 regulations do not in any way lessen DOE's responsibility to 
site, design, and operate the proposed repository safely. Much has been 
learned regarding the expected performance of geologic repositories in 
general (Nuclear Energy Agency, Lessons Learnt from Ten Performance 
Assessment Studies, Paris, France, NEA/OECD Working Group on Integrated 
Performance Assessments for Geologic Repositories, 1997), and a 
potential Yucca Mountain repository in particular over the nearly two 
decades since part 60 was written. Part 63 reflects and incorporates 
much of this new information. The risk-informed, performance-based 
approach used to develop the rule (see SECY-97-300, ``Proposed Strategy 
for Development of Regulations Governing Disposal of High-Level 
Radioactive Wastes in a Proposed Repository at Yucca Mountain,'' U.S. 
NRC, December 24, 1997) eliminates arbitrary or prescriptive siting and 
design criteria, as well as detailed requirements such as quantitative 
subsystem performance objectives. That being said, however, part 63 
still requires DOE to demonstrate reliance on multiple barriers and 
defense in depth, preservation of the retrieval option, implementation 
of a performance confirmation program, transparency in decision making, 
and application of rigorous quality assurance (QA). Moreover, as a 
result of public comments, other provisions have been added to part 63 
to ensure the adequacy and sufficiency of DOE's compliance 
demonstrations. (See Multiple Barriers and Defense in Depth for 
additional discussion on quantitative subsystem requirements.)

1.2  Differences Between Part 63 and EPA Standards for WIPP

    Issue: Why is there a difference between the performance objectives 
in NRC's proposed 10 CFR part 63 for Yucca Mountain and EPA's 40 CFR 
part 191 standards used to certify the Waste Isolation Pilot Project 
(WIPP)?
    Comment. Many commenters expressed concern that NRC's proposed 
regulations for Yucca Mountain provided less protection than EPA's 
standards for WIPP. They regarded NRC's proposed regulations as less 
stringent than the standards for WIPP. Many cited the absence of 
separate criteria for protection of ground water in NRC's proposed 
regulation as evidence that the WIPP standards, which include separate 
requirements for protection of ground water, are more restrictive. 
Commenters also cited the differences in the individual protection 
limits [0.15 mSv/year (15 mrem/year) for WIPP compared to 0.25 mSv/year 
(25 mrem/year) limit for Yucca Mountain], and the compliance location 
(5 km for WIPP compared to approximately 20 km for Yucca Mountain). 
Generally, commenters asked NRC to set standards similar to, or more 
stringent than, those for WIPP. Some argued that a greater level of 
protection for people near Yucca Mountain was needed to offset 
potential exposures from other sources in the region (i.e., the Beatty 
low-level waste site and the Nevada Test Site, NTS).
    Response. Final EPA standards adopted numerical limits that are 
comparable to those applied at WIPP. Consistent with the views 
expressed by a majority of commenters, the Commission has awaited EPA's 
publication of final standards for Yucca Mountain and is adopting final 
part 63 criteria that are consistent with those limits, as required by 
law.

1.3  Multi-Staged Licensing

    Issue 1: Should DOE be allowed to begin to place waste in the 
repository or to store waste in surface facilities once NRC has 
determined that there is enough space for initial operations, or should 
DOE have to wait until site construction is complete?
    Comment. Many commenters indicated that NRC should not allow DOE to 
place waste in the repository until construction is complete. These 
commenters had general concerns that only after construction is 
completed would emergency equipment and safety precautions be available 
in case of an accident; and that any waste, if emplaced before 
completing construction, may pose an unnecessary risk to the 
construction workers. Alternatively, other commenters suggested that 
storage of waste at the repository should be allowed during 
construction as long as it does not pose any additional health or 
safety risk. The Nuclear Energy Institute (NEI) suggested that part 63 
should be changed so that NRC could authorize DOE to construct all or 
part of the geologic repository operations area (GROA), and could 
authorize early use of the surface facilities to store waste.
    Response. The proposed rule retained the licensing phases as 
described at part 60. Once construction of the GROA is substantially 
complete (as specified at Sec. 63.41), DOE may update its application 
and the Commission may issue a license to receive and possess source, 
special nuclear, or byproduct material at the GROA. Prior to issuing 
such a license, the Commission must make certain findings, such as: (1) 
Activities to be conducted at the GROA comply with the rules and 
regulations of the Commission, which will include radiation protection 
for workers; (2) adequate protective measures can and will be taken in 
the event of a radiological emergency; (3) there is no unreasonable 
risk to the health and safety of the public; and (4) construction of 
the GROA has been substantially completed. Construction is deemed

[[Page 55738]]

substantially complete, for this purpose, if among other things, DOE 
has completed construction of sufficient underground storage space for 
initial operations. Thus, part 63 provides DOE flexibility to plan for 
efficient repository operations for receipt and emplacement of waste 
because of the significant length of time required to complete 
excavation of the entire underground facility.
    The DOE has not indicated to the Commission any intention to seek 
an authorization for early use of the surface facilities for storage of 
spent nuclear fuel. Such an authorization likely would necessitate a 
change to (or an exemption from) the regulations. Before NRC would make 
changes of this type to its regulations, NRC would need to publish the 
proposed changes and seek public comment.
    Issue 2: Should DOE have to prepare a second EIS to support a 
decision to issue a license amendment for permanent closure, as this 
may constitute a major Federal action?
    Comment. Commenters stated that the license amendment for permanent 
closure is a major Federal action and should require a new EIS (i.e., 
not rely upon the EIS prepared for the license application). They 
expressed the view that a decision to issue an amendment for permanent 
closure would include a decision that retrieval of the waste is not 
necessary and that the expected impacts of the waste affecting the 
environment far into the future and far beyond the site are acceptable. 
They also pointed out that the decision to issue the license amendment 
will be based, in part, on performance confirmation data collected 
after the original EIS is submitted. One commenter was concerned that 
the proposed requirement at Sec. 51.67 did not explicitly state the 
need to include measures to mitigate impacts including transportation.
    Response. The regulations require DOE to supplement its EIS, if 
necessary, when the application for the license amendment for permanent 
closure is submitted [Sec. 63.51(b)]. The decision involved in granting 
the amendment would be a subset of decisions made in the original EIS 
and any supplements. A supplement to the EIS would need to address such 
things as substantial changes to the proposed action or significant new 
circumstances or information relevant to environmental concerns. The 
Commission believes the commenters' request for requiring DOE to 
consider these matters at the time of permanent closure is adequately 
covered by the regulations.
    The Commission did not adopt the suggested change to Sec. 51.67 to 
include a specific requirement to consider mitigation measures that the 
Council on Environmental Quality (CEQ) regulations dictate for the 
contents of the EIS, which include requirements for consideration of 
measures to mitigate impacts including transportation. DOE would need 
to comply with applicable CEQ requirements, and the Commission does not 
believe any regulatory changes are necessary to ensure compliance by 
DOE.
    Issue 3: Is there any limit on the types and amounts of radioactive 
materials (e.g., tons of HLW) that DOE would be allowed to receive and 
possess at Yucca Mountain if these materials were for site 
characterization activities or testing during construction?
    Comment. EPA suggested that, under the proposed rule (Secs. 63.7(a) 
and 63.74(a)(1)), DOE could take any types and amounts of radioactive 
materials onto the site if it claimed that the materials were for site 
characterization activities.
    Response. EPA correctly notes that proposed part 63 does not place 
any specific quantitative limit on the amount of radioactive materials 
DOE might use for site characterization or testing. However, a specific 
numerical limit is unnecessary. Section 113(c)(2)(A) of the NWPA 
prohibits the DOE from using radioactive material in conducting site 
characterization activities unless the Commission concurs that such use 
is necessary. Under Sec. 63.16(a), if DOE's planned site 
characterization activities include onsite testing with radioactive 
material, the Commission must determine whether the proposed use of 
radioactive material is necessary. The Commission would not concur in 
any DOE proposal to bring radioactive materials on site unless it was 
convinced that both the types and amounts were needed for site 
characterization. The proposed part 63 would not have allowed DOE to 
receive and possess ``any types or amounts'' of radioactive materials 
as suggested by EPA. Thus, changes to the proposed regulations are not 
needed.
    Issue 4: In a multi-staged licensing approach, does the NRC require 
that all information be available at the first stage (i.e., 
construction authorization) or will DOE be allowed to provide certain 
information in a ``staged'' manner consistent with that particular 
stage of the licensing process?
    Comment. DOE commented that it intends to provide a sufficient 
level of information to allow the NRC to make a finding of reasonable 
assurance at the time of the construction authorization in accordance 
with Sec. 63.31. However, DOE stated that it would be helpful if the 
Commission would clarify its intent regarding the level of information 
required in the license application. In particular, DOE recommended 
three changes to proposed subpart B: (1) The language of 
Sec. 63.21(b)(3) calling for ``a detailed plan'' to provide physical 
protection for HLW should be changed to a ``description of the plan'' 
to provide physical protection for HLW because this would be more 
consistent with the language used in other provisions of Sec. 63.21(b) 
and would reflect what DOE believes to be an adequate level of detail 
on this subject; (2) the proposed Sec. 63.24(a) requirement that the 
application be as complete as possible at the time of docketing based 
on reasonably available information should be moved to Sec. 63.21(a) 
because this section provides requirements for the content of the 
license application; and (3) the proposed finding that the Commission 
would make to authorize construction at Sec. 63.31(a)(6) that ``DOE's 
proposed operating procedures to protect health and to minimize danger 
to life or property are adequate'' should be changed to ``DOE's 
proposed plan to develop operating procedures'' because, at the time of 
construction authorization, details of the repository design will not, 
in some cases, be sufficient to support development of operating 
procedures and DOE does not believe that the procedures need to be in 
place at this stage of the licensing process. Another commenter 
suggested that the regulations for each licensing stage should be 
modified to state explicitly that the corresponding Commission finding 
must take into account ``the scope of the authorization requested and 
the information available.''
    Response. part 63 provides for a multi-staged licensing process 
that affords the Commission the flexibility to make decisions in a 
logical time sequence that accounts for DOE collecting and analyzing 
additional information over the construction and operational phases of 
the repository. The multi-staged approach comprises four major 
decisions by the Commission: (1) Construction authorization; (2) 
license to receive and emplace waste; (3) license amendment for 
permanent closure; and (4) termination of license. The time required to 
complete the stages of this process (e.g., 50 years for operations and 
50 years for monitoring) is extensive and will allow for generation of 
additional information. Clearly, the knowledge available at the time of 
construction authorization will be less than at the subsequent stages. 
However,

[[Page 55739]]

at each stage, DOE must provide sufficient information to support that 
stage. DOE has stated its intent to submit, and NRC expects to receive, 
a reasonably complete application at the time of construction 
authorization to allow the Commission to make a construction 
authorization decision. This is reflected in the requirement at 
Sec. 63.24(a) that the application be as complete as possible in light 
of information that is reasonably available at the time of docketing. 
The Commission believes the regulations, as proposed, provide the 
necessary flexibility for making licensing decisions consistent with 
the amount and level of detail of information appropriate to each 
licensing stage. However, we agree with DOE that the proposed 
requirement at Sec. 63.24(a) speaks to the content of the initial 
application, as well as to all subsequent updates, and, therefore, it 
has been included at the end of Sec. 63.21(a).
    Regarding DOE's recommendation that the requirement for a 
``detailed plan'' to provide physical protection be changed to require 
a ``description of the plan,'' the Commission agrees that the suggested 
revision provides greater consistency with other provisions of 
Sec. 63.21(b) and with Sec. 72.24(o) and has revised Sec. 63.21(b)(3) 
to require ``(a) description of the detailed security measures for 
physical protection of high-level radioactive waste in accordance with 
Sec. 73.51 of this chapter.'' Notwithstanding this change, DOE must 
provide sufficient information at each stage of the licensing process 
to support that stage, and DOE must provide sufficient detail necessary 
to allow NRC to review DOE's design.
    Regarding DOE's recommendation that the requirement that ``DOE's 
proposed operating procedures'' are adequate be changed to require the 
adequacy of ``DOE's proposed plan to develop operating procedures,'' 
the Commission believes a proposed plan to develop operating procedures 
is not sufficient to meet the requirement at Sec. 63.31(a)(6). However, 
to support the construction authorization, the DOE must provide a 
sufficient level of information to allow NRC to review DOE's design, 
which would include any operating procedures that affect design.
    Issue 5: Is there any control over the site after license 
termination?
    Comment. Commenters expressed general concern regarding oversight 
of the site after license termination. One commenter supported the 
approach in proposed part 63 that leaves a single agency (DOE) 
responsible for control over the site after license termination.
    Response. License termination represents the end of NRC involvement 
with the repository. However, the Commission would not terminate the 
license unless and until all requirements have been met by DOE. License 
termination removes NRC oversight of the Yucca Mountain site, leaving 
DOE as the single Federal authority responsible for the site. Under the 
proposed part 63, the license amendment for permanent closure must 
include a DOE 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 radiation exposure of 
individual members of the public beyond allowable limits. The final 
part 63 continues to retain these same requirements. This is consistent 
with statutory direction in section 801(b)(2) of EnPA that the 
Commission's requirements assume that, following repository closure, 
the inclusion of engineered barriers and DOE's postclosure oversight 
will be sufficient to prevent any activity at the site that poses an 
unreasonable risk of breaching the repository's engineered or geologic 
barriers, and prevent any increase in the exposure of individual 
members of the public to radiation beyond allowable limits. The NRC 
will review the adequacy of DOE's program for continued oversight at 
the time DOE submits an application to amend the license for permanent 
closure.
    Issue 6: Are the standards for issuance of a license sufficiently 
clear?
    Comment. EPA asked why the term ``unreasonable risk'' was used at 
Sec. 63.41(c) and suggested that reference to the dose limit may be 
more appropriate. EPA also asked what the basis was for judging what is 
necessary for ``common defense and security'' at Sec. 63.42.
    Response. The standards for issuance of a license specified at 
Sec. 63.41 and conditions of the license at Sec. 63.42 provide a 
general description of standards and conditions that the Commission 
will apply to a license application for an HLW repository at Yucca 
Mountain. They would include, among other things, compliance with dose 
limits established by EPA in its final standards for Yucca Mountain. 
Although the terms identified by EPA (i.e., ``unreasonable risk'' and 
``common defense and security'') are general terms, clarification for 
what is required is provided earlier in the regulation. In particular, 
requirements for the content of the license application (specified at 
Sec. 63.21) describe and clarify the types of analyses and information 
that would be necessary for DOE's demonstration of compliance with 
these standards and conditions including, among other things, reference 
to dose limits and physical protection of the repository (i.e., common 
defense and security). Revision of Sec. 63.21 in the proposed rule to 
provide additional clarification of these terms is considered 
unnecessary.

1.4  Reasonable Assurance

    Issue 1: Should a concept other than ``reasonable assurance'' be 
incorporated into the implementing regulations for Yucca Mountain?
    Comment. EPA commented that generic disposal standards at 40 CFR 
Part 191 require compliance to be demonstrated with ``reasonable 
expectation,'' and that proposed NRC implementing regulations for Yucca 
Mountain at Part 63 require demonstration with ``reasonable 
assurance.'' EPA believes that a connotation has developed around 
``reasonable assurance'' that could lead to an extreme approach of 
selecting worst case values for important parameters. EPA believes that 
``reasonable assurance'' is appropriate for operating facilities or in 
the context of the nuclear power plant licensing program where 
facilities operate under active institutional controls during their 
lifetime. It is not appropriate, in EPA's view, for the licensing of a 
repository where projections of performance have inherently large 
ranges of uncertainty. EPA prefers ``reasonable expectation'' because 
it believes ``reasonable assurance'' has come to be associated with a 
level of confidence that is not appropriate for the very long term 
analytical projections that will be necessary for evaluating Yucca 
Mountain.
    Another commenter expressed the view that the majority of people in 
the HLW field view ``reasonable assurance'' as being more stringent 
than ``reasonable expectation.'' This commenter expressed the concern 
that it is likely that by requiring ``reasonable assurance'' the NRC 
will be seen as implementing EPA's standards in a manner more stringent 
than intended by the EPA. The commenter also indicated that if it is 
NRC's position that the two terms are synonymous in the context of HLW 
disposal, then this should be made more explicit.
    Response. Confidence that DOE has, or has not, demonstrated 
compliance with EPA's standards is the essence of NRC's licensing 
process. It is the Commission's responsibility to determine whether DOE 
has or has not demonstrated compliance. The Commission does not believe 
that NRC's use of ``reasonable assurance'' as a basis

[[Page 55740]]

for judging compliance compels focus on extreme values (i.e., tails of 
distributions) for representing the performance of a Yucca Mountain 
repository. Further, if DOE is authorized to file a license 
application, and if the Commission is called on to make a decision, 
irrespective of the term used, the Commission will consider the full 
record before it. That record will include many factors in addition to 
whether the site and design comply with the performance objectives 
(both preclosure and postclosure performance standards) contained in 
Subparts E, K and L. The Commission could consider the QA program, 
personnel training program, emergency plan and operating procedures, 
among others, in order to determine whether it has confidence that 
there is no unreasonable risk to the health and safety of the public.
    To avoid any misunderstanding and to achieve consistency with final 
EPA standards, the Commission has decided to adopt EPA's preferred 
criterion of ``reasonable expectation'' for purposes of judging 
compliance with the postclosure performance objectives. The Commission 
is satisfied that a standard of ``reasonable expectation'' allows it 
the necessary flexibility to account for the inherently greater 
uncertainties in making long-term projections of a repository's 
performance. The Commission agrees with EPA and others that it is 
important to not exclude important parameters from assessments and 
analyses simply because they are difficult to precisely quantify to a 
high degree of confidence. By adopting what EPA has characterized as a 
more flexible standard of ``reasonable expectation'' for determining 
compliance with postclosure performance objectives, the Commission 
hopes to make clear its expectations. The Commission expects that the 
required analyses of postclosure performance will focus on the full 
range of defensible and reasonable parameter distributions, and that 
they should not be constrained only to extreme physical situations and 
parameter values. For other determinations regarding compliance of the 
repository with preclosure objectives, the Commission will retain a 
standard of ``reasonable assurance,'' consistent with its practice for 
other licensed operating facilities subject to active licensee 
oversight and control.
    Issue 2: Does the term ``reasonable assurance'' denote a specific 
statistical parameter related to either the probability distribution of 
calculated individual doses or important variables used in that 
calculation?
    Comment. EPA commented that a connotation has developed around 
``reasonable assurance'' that could lead to an extreme approach to 
selecting worst case values for important parameters used to calculate 
individual dose (for example, precipitation rates, seepage rates, and 
flow in the unsaturated zone). According to the EPA, that approach, 
coupled with an equally extreme approach in selecting engineered 
barrier performance factors, would lead to assessments that represent 
situations with little or no probability of occurring but which become 
the basis for licensing decisions. The EPA concludes that the 
application of the ``reasonable assurance'' standard: (1) Is 
inconsistent with the NAS recommendation to use ``cautious, but 
reasonable'' assumptions when projecting the performance of the 
geologic repository; and (2) would result in applying margins of safety 
beyond the standard for individual protection set by EPA, which, in 
effect, alters that standard.
    Another commenter noted that the proposed part 63 makes it clear 
that compliance is to be based on calculations of ``expected annual 
dose'' and that this requirement is completely consistent with the 
recommendation in the NAS report on ``Technical Basis for Yucca 
Mountain Standards,'' which recommends that the mean values of 
calculations be the basis for comparison with the NAS recommended 
standards. However, the commenter was concerned that ``reasonable 
assurance'' may be interpreted to be more stringent than the mean 
values of calculations of individual dose and recommended that it be 
made clear that, in the context of Yucca Mountain, ``reasonable 
assurance'' refers to the mean or expected value of the relevant 
probability distribution.
    Response. As stated previously, in order to avoid further 
misunderstanding of its intent, the Commission will adopt EPA's 
preferred standard of ``reasonable expectation'' for purposes of 
judging compliance with the numerical postclosure performance 
objectives. However, the Commission wants to make clear that its 
proposed use of ``reasonable assurance'' as a basis for judging 
compliance was not intended to imply a requirement for more stringent 
analyses (e.g., use of extreme values for important parameters) or for 
comparison with a potentially more stringent statistical criteria 
(e.g., use of the 95th percentile of the distribution of the estimate 
of dose).

2  Requirements for the Preclosure Period

2.1  Preclosure Safety Analysis

    Issue 1: Is the use of an Integrated Safety Assessment (ISA) 
appropriate for evaluation of the preclosure safety of a repository at 
Yucca Mountain?
    Comment. One commenter questioned the use of an ISA, as derived 
from chemical process safety analyses, to evaluate preclosure safety 
because there is not yet much experience in regulating with the ISA and 
suggested that requirements for monitored retrievable storage (as 
contained in part 72) should be applicable to the GROA and should be 
used in place of the proposed requirements of part 63.
    Response. The Commission considers necessary the analysis referred 
to in the proposed rule as an ``integrated safety analysis''. However, 
for clarity, in the final rule, the Commission has changed the name of 
the analysis to ``preclosure safety analysis'' (PSA).
    The proposed rule identifies the need for, and general scope of, 
the analysis to be done to demonstrate compliance with the performance 
requirements for the operational phase of the repository 
(Secs. 63.111(a) and (b) and 63.112(e)). The Commission did not intend 
to imply, however, that a particular approach, such as that used for 
chemical process safety analyses, was required. The Commission's 
intention was to identify ISA as a broad category of analyses to be 
used by DOE in its evaluation of repository operations and design in 
the context of meeting the preclosure performance objectives. ISA was 
proposed as a general term for these preclosure analyses, much as the 
general term ``performance assessment'' is used to denote the analyses 
used to evaluate postclosure performance. To avoid confusion with any 
particular type of analysis associated with other industrial 
facilities, the term ``ISA'' will be replaced by the more general term 
``preclosure safety analysis (PSA).'' The Commission intends that DOE 
have broad flexibility in structuring its PSA for purposes of 
demonstrating compliance with the requirements at Sec. 63.112.
    The Commission recognizes that there are similarities between a 
facility regulated by Part 72 and the GROA facilities proposed for 
Yucca Mountain. However, there are important differences (e.g., Part 72 
does not consider a mined facility) that make it impractical to merely 
adopt the requirements of the current part 72. The Commission has used 
and adopted relevant portions of existing regulations (e.g., part 50), 
including part 72, to the

[[Page 55741]]

extent practical, during the development of proposed part 63.
    Issue 2: Is the probability of a design basis event (DBE) based on 
the event sequence or just an initiating event? Are the criteria for 
Category 2 DBEs too stringent?
    Comment. DOE suggested that the rule should be clarified as to 
whether event sequences or single initiating events are to be used in 
determining the probabilities of DBEs. DOE also noted that the proposed 
rule would define Category 2 DBEs as those that have one chance in 
10,000 of occurring before permanent closure of the repository or an 
annual probability of about 10-6. DOE stated that:

    Designing to this probability is a reasonable goal in general, 
but that there are specific concerns with applying the definition to 
natural events, which have existing precedent for the magnitude and 
frequency of events to be included *ensp;* *ensp; A 
1010-6 earthquake is far beyond normal design 
considerations.

    DOE suggested the following definitions of DBEs:
    Definition for Category 1 DBEs should be revised to read: ``natural 
events and human-induced event sequences.''
    Definition for Category 2 DBEs should be revised to read: ``other 
human-induced event sequences that have at least one chance in 10,000 
of occurring before permanent closure of the geologic repository, and 
(b) appropriate consideration of natural events (phenomena) that have 
been historically reported for the site and the geologic setting 
(referred to as Category 2 events).''
    Response. The Commission agrees that the basis for determining the 
probability for design basis events and what initiating events should 
be considered in the safety analysis should be clarified. The 
Commission considers that the changes to the rule suggested by DOE are 
not sufficiently clear and has not adopted these changes in the final 
rule. However, the Commission has revised the rule for clarity as 
follows: (1) A new term ``initiating event'' is defined; (2) the 
present term ``design basis event'' is replaced with a new term ``event 
sequence;'' and (3) Sec. 63.102(f) is revised to clarify the scope of 
the PSA and the requirements for the inclusion or exclusion of 
specific, naturally-occurring, and human-induced hazards in the safety 
analysis.
    The proposed rule described the ISA (referred to as PSA in final 
part 63) as a systematic examination of the hazards and their potential 
consequences [see Sec. 63.102(f)]. In the Supplementary Information for 
the proposed rule, Category 2 design basis events were discussed as 
follows:

    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) 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 intended that the probability of the entire event 
sequence, including initiating event(s) and the associated combinations 
of repository system or component failures, be considered in dose 
calculations. The proposed rule has been revised by replacing the 
previous term ``design basis event'' with new terms ``initiating 
event'' and ``event sequence'' and associated definitions. These 
changes clarify that the appropriate probability is based on the entire 
event sequence, which includes the initiating event(s) and associated 
combinations of repository system or component failures relating to the 
potential release of radioactive material.
    The two critical aspects of the PSA in the context of this issue 
are (1) the identification of the event sequences that have 
probabilities greater than or equal to one chance in 10,000 of 
occurring before permanent closure and (2) the associated dose 
consequences. Following the intent of risk-informed performance-based 
regulation, designation of specific design basis criteria in the 
regulation is not appropriate. The goal of the DOE design activity 
should be to demonstrate that the dose limits expressed in Sec. 63.111 
will be met, taking into consideration site-specific information 
regarding the geologic setting and human activities in the surrounding 
environs. For example, if a hazard (or the low probability events of 
the hazard spectrum) is deemed unreasonable for the Yucca Mountain 
site, DOE can exclude it from consideration in the PSA provided proper 
technical justification is presented in accordance with Sec. 63.112(d). 
Thus, while the regulation specifies a lower limit on the probability 
of event sequences, the risk-informed NRC regulation anticipates that 
DOE will develop a clear technical basis for the event sequences 
included/excluded from the PSA. The Commission did not intend to 
specify cut-off probabilities for initiating events but recognizes that 
certain initiating events may not be appropriate for inclusion in the 
PSA. Therefore, the rule, at Sec. 63.102(f), has been revised to 
include the following description of considerations that can be used by 
the DOE to limit the inclusion of initiating events in the PSA:

    Initiating events are to be considered for inclusion in the 
preclosure safety analysis for determining event sequences only if 
they are reasonable (i.e., based on the characteristics of the 
geologic setting and the human environment, and are consistent with 
precedents adopted for nuclear facilities with comparable or higher 
risks to workers and the public).

    Issue 3: How should doses be estimated in evaluating repository 
operations during the time before permanent closure? Can different 
approaches be used for evaluating Category 1 and Category 2 DBEs (event 
sequences)?
    Comment. Further clarification is needed on the scope of the dose 
calculations associated with DBEs (event sequences).
    For Category 1 DBEs [event sequences], DOE recommended a realistic 
or best-estimate analysis for direct exposures from a single event. For 
airborne pathways, DOE proposed including submersion, inhalation, and 
ingestion. DOE also recommended that the doses from all Category 1 DBEs 
(event sequences) be aggregated.
    For Category 2 DBEs (event sequences), DOE recommended dose 
calculations be based on suitably conservative values for direct 
exposure and airborne pathways including submersion, and inhalation, 
but not ingestion. DOE recommended that ingestion not be considered 
because the focus is on an acute dose, not a dose that occurs slowly 
over time as is the case for ingestion. Also, the emergency planning 
would mitigate, if necessary, contamination relevant to ingestion. DOE 
also recommended that Category 2 DBEs [event sequences] be analyzed on 
an event sequence by event sequence basis.
    Response. The Commission has revised the proposed rule, at 
Sec. 63.111(b)(1) and (2), to clarify that (1) the doses from 
consequence analyses for Category 1 event sequences are to be 
aggregated to a single estimate and (2) the dose from the consequence 
analysis for each Category 2 event sequence is to be estimated for that 
specific event sequence only. Thus, each Category 2 event sequence dose 
is to be evaluated

[[Page 55742]]

separately. The doses from Category 2 event sequences that might occur 
at different times during the preclosure period are not to be 
aggregated.
    DOE raised a number of concerns with the scope of the dose 
calculations associated with event sequences. Generally, DOE called for 
details that are typically found in regulatory guidance rather than 
regulation. Although such guidance is expected to be included in the 
Yucca Mountain Review Plan (YMRP) rather than in the regulation, the 
NRC staff response to DOE's concerns regarding dose calculations 
associated with event sequences is summarized below.
    Within the context of the ISA (PSA), DOE is expected to identify 
the relevant initiating events and event sequences and estimate 
potential radiologic exposures. Part 63 provides flexibility to DOE in 
selecting an appropriate approach for estimating doses, including 
selection of pertinent exposure pathways and the degree of conservatism 
or realism to include in the analysis. DOE will need to defend and 
support whatever approach it selects for identifying initiating events 
and analyzing event sequences. In the selection of a particular 
approach, DOE will need to consider the uncertainties and limitations 
associated with a particular method of analysis and data.
    DOE suggested that a ``realistic or best-estimate'' analysis is 
appropriate for Category 1 event sequences, and a ``suitably 
conservative'' analysis is appropriate for Category 2 event sequences. 
Once again, the approach in the rule is to provide DOE flexibility to 
select the type of analysis it believes most appropriate for the 
license application. Whatever approach DOE uses will need to be 
supported, taking into account uncertainties. Therefore, analyses 
relying on point values (e.g., best estimate values) will need to 
discuss how uncertainties are taken into account.
    DOE suggested that dose estimates for Category 1 DBEs (event 
sequences) should be aggregated into a single annual dose estimate. 
This approach is consistent with historical practices and is acceptable 
to NRC. DOE also suggested that the potential dose arising from the 
occurrence of each Category 2 DBE (event sequence) should be estimated 
separately (i.e., not be aggregated). The Commission agrees that each 
Category 2 event sequence is to be evaluated individually, as this 
approach is consistent with historical practices. Also, analyzing each 
event sequence separately provides a high degree of transparency in the 
analysis, thus allowing NRC to evaluate the postulated events, the 
associated event sequences, and the engineered components that affect 
the likelihood and magnitude of potential releases of radioactive 
material. The Commission has revised the rule at Sec. 63.111(b)(1) and 
(2) to clarify that dose estimates for Category 1 event sequences are 
to be aggregated, but those of Category 2 event sequences are to be 
analyzed and documented individually.
    DOE also suggested that, for Category 2 DBEs (event sequences), 
dose calculations for ingestion are not necessary. The Commission sees 
no compelling logic for the specific pathways for dose calculations 
being different for Category 1 and Category 2 event sequences. Dose 
should be calculated considering all pathways relevant to an event 
sequence. Consistent with the Commission requirements elsewhere, the 
DOE must consider all pathways in demonstrating compliance with 
Sec. 63.111. The risk-informed regulation anticipates that DOE will 
present in its license application the magnitude of, and the technical 
basis for, the dose contribution of various pathways, including the 
technical bases for eliminating any pathway.
    Issue 4: What precedents, if any, do NRC regulatory guides 
developed for other applications, such as nuclear power plants, have 
for use in developing DBEs (event sequences) for a potential repository 
at Yucca Mountain?
    Comment. DOE asked for clarification about the role of precedents 
in other regulatory guides (e.g., consideration of earthquakes, 
aircraft crashes, tornadoes, and flooding) in determining what should 
be considered in the development of DBEs (event sequences) (especially 
for Category 2). DOE also commented that development of credible 
natural events, for Category 2 DBEs (event sequences), would require 
only following applicable regulatory precedents and considering severe 
natural phenomena that have been historically reported for the site and 
geologic setting.
    Response. The applicability of regulatory guidance developed for 
facilities other than a high-level waste repository will need to be 
considered on a case-by-case basis for applicability to high-level 
waste disposal at Yucca Mountain. For the guidance to be appropriate, 
it should be generally applicable to nuclear facilities with comparable 
or higher risks to workers and the public than the potential repository 
at the Yucca Mountain site (see discussion under Issue 2).
    Issue 5: What is the status of NRC's provisional acceptance of 
DOE's Topical Report on Seismic Design for Yucca Mountain with respect 
to event sequences in part 63?
    Comment. DOE inquired about the status of NRC's provisional 
acceptance of DOE's Topical Report on Seismic Design for Yucca Mountain 
with respect to event sequences in Part 63.
    Response. DOE's Topical Reports 1 and 2 on Seismic Design for Yucca 
Mountain were provisionally accepted prior to NRC's issuance of 
proposed requirements at part 63. The applicability of DOE's seismic 
design methodology will be reviewed after final part 63 requirements 
are in place and DOE has completed Topical Report 3.
    Issue 6: Should there be an explicit requirement for an analysis of 
the effects of any plans for use of the air space above the GROA?
    Comment. One commenter recommended an analysis of the effects of 
any plans for use of the air space above the GROA.
    Response. Any plans for use of the air space above the GROA that 
would affect compliance with the performance objectives should be 
included in the PSA. The Commission finds no reason for a separate 
requirement for such an analysis.
    Issue 7: Will NRC have its own experts to evaluate what can happen 
during repository operations or will NRC rely on the DOE analysis?
    Comment. One commenter inquired whether NRC had independent experts 
to develop probabilities for DBEs, or would NRC simply rely on DOE 
analyses.
    Response. The Commission will perform an audit review of the DOE 
license application including a review of the technical basis for 
initiating events and event sequences. In performing the audit review, 
the NRC will use a variety of its technical staff with appropriate 
technical experience and skills, and experience with comparable 
activities for other facilities (handling of nuclear fuel at nuclear 
reactors and fuel fabrication facilities) regulated by NRC. 
Additionally, the NRC's HLW contractor (The Center for Nuclear Waste 
Regulatory Analyses, CNWRA) has a wide range of technical expertise to 
assist NRC staff in any review conducted.
    Issue 8: Is the terminology in the rule consistent and adequate to 
convey what is required?
    Comment. DOE identified instances where particular words or phrases 
in Part 63 lacked clarity and suggested the following changes:
    Section 63.112(b) should be revised to read: ``An identification 
and systematic analysis of naturally-occurring and

[[Page 55743]]

human-induced hazards at the geologic repository operations area, 
including a comprehensive identification of potential design basis 
events'' (The definition of DBEs makes no link to consequence, whereas 
Sec. 63.112(b) inappropriately implies such a link).
    The word ``accidents'' in Sec. 63.112(e) should be replaced with 
``design basis events'' (the word ``accidents'' is not defined (also in 
Sec. 63.161)--use of DBE is consistent with language elsewhere in part 
63).
    Response. The Commission agrees that the use of the word 
``accident'' in Sec. 63.112(e) is vague and will replace ``accident'' 
by ``event sequence.'' Additionally, the Commission has revised the 
language at Sec. 63.112(b) to remove the inappropriate reference to 
consequences.
    Issue 9: Should the proposed rule prescribe requirements for the 
ISA (PSA)?
    Comment. DOE noted that prescribing requirements for the ISA (PSA) 
at Sec. 63.112 was inconsistent with the overall performance-based 
approach in the rule.
    Response. The rule identifies topics that need to be included in 
the PSA but does not prescribe either the methodology to use or the 
depth to which these topics need to be addressed. part 63 appropriately 
identifies the topics that need to be included in the PSA to ensure 
DOE's analysis is complete and yet gives DOE flexibility to determine 
the level of detail needed to address each topic properly. This 
performance-based approach provides DOE latitude to adjust the 
technical rigor of its evaluation of any particular topic in a manner 
that is consistent with the topic's importance to safety.

2.2  Retrievability

    Issue 1: Will NRC require DOE to demonstrate that the waste package 
is retrievable?
    Comment. Some commenters were concerned that NRC's proposed 
regulations required DOE to submit plans for retrievability, but did 
not require an actual demonstration that the plans were feasible. Some 
commenters suggested that the NRC should require DOE to demonstrate the 
feasibility of its retrieval plans.
    Response. If necessary to protect public health and safety, waste 
package retrieval in a deep geologic repository would be a first-of-a-
kind endeavor with unique engineering and geotechnical challenges. The 
Commission recognizes that the retrieval operation would be an unusual 
event, and may be an involved and expensive operation (U.S. Nuclear 
Regulatory Commission, ``Staff Analysis of Public Comments on Proposed 
Rule 10 CFR part 60, `Disposal of High-Level Radioactive Wastes in 
Geologic Repositories','' Office of Nuclear Regulatory Research, NUREG-
0804, December 1983; p. 11). As such, DOE can expect that its plans and 
procedures in this area will receive extensive, detailed review by the 
NRC staff as part of any construction authorization review. The 
feasibility and reasonableness of DOE's retrieval plans will be 
reviewed by the NRC staff at the time of the license application 
submittal.
    However, the Commission does not envision that DOE will need to 
build full-scale prototypes of its retrieval systems to demonstrate 
that its retrieval plans are practicable at the time of construction 
authorization. Rather, DOE needs to design (and build) the repository 
in such a way that the retrieval option is not rendered impractical or 
impossible.
    Issue 2: Why did NRC set an upper limit for retrieval at 50 years 
after waste emplacement operations are initiated?
    Comment. Some commenters expressed a belief that the period of 
waste package retrieval could be accomplished beyond 50 years, and 
there should be flexibility for extending the period of retrievability 
to longer time periods. One commenter suggested that the repository 
should be monitored to determine if there will be problems (e.g., too 
high a temperature, too much water inflow) that would require the waste 
to be retrieved. The same commenter suggested that stewardship of the 
waste be maintained (indefinitely) so that waste could be made 
available for future energy needs.
    Response. The 50-year limit on waste retrieval operations was 
adopted from the generic requirements found at part 60. At the time 
part 60 was first promulgated, the Commission solicited comment on what 
was then a proposed 110-year retrieval period (46 FR 35282; July 8, 
1981). However, after an analysis of public comments, it was determined 
that the Commission's earlier proposal was excessive, and the shorter 
50-year period was decided upon (U.S. Nuclear Regulatory Commission, 
``Staff Analysis of Public Comments on Proposed Rule 10 CFR part 60, 
`Disposal of High-Level Radioactive Wastes in Geologic Repositories','' 
Office of Nuclear Regulatory Research, NUREG-0804, December 1983). In 
specifying this time period, the Commission noted that the 50-year 
period was ``provisional'' and subject to possible modification (i.e., 
longer periods) in light of both the planned waste emplacement schedule 
and completion of the performance confirmation program and a review of 
those results. After 50 years of waste emplacement operations and 
performance confirmation, the Commission previously reasoned, it is 
likely that significant technical uncertainties will be resolved, 
thereby providing greater assurance that the performance objectives 
will be met. It should be noted that DOE is free to design the 
repository for retrieval periods greater than 50 years. In fact, the 
Commission understands that DOE is contemplating working designs that 
may provide for a retrieval period of up to 300 years (see ``Supplement 
to the Draft Environmental Impact Statement for a Geologic Repository 
for the Disposal of Spent Nuclear Fuel and High-Level Radioactive Waste 
at Yucca Mountain, Nye County, Nevada,'' Office of Civilian Radioactive 
Waste Management, DOE/EIS-0250DS, May 2001). Thus, as recommended in 
this comment, allowance for longer waste retrieval periods greater than 
50 years is permitted under the regulation.
    As for longer retrieval periods that would permit the recovery of 
the HLW as a potential resource, the Commission has previously noted 
that its retrieval provision is not intended to facilitate recovery. 
Waste retrieval is intended to be an unusual event only to be 
undertaken to protect public health and safety.
    Issue 3: If retrieval is necessary, what happens to the retrieved 
waste?
    Comment. One commenter inquired as to the disposition of the waste 
if it is determined that retrieval is necessary.
    Response. Proposed Part 63 does not specifically address any 
required actions for the handling of retrieved waste from an operating 
geologic repository, but Sec. 63.21(c)(19) [moved to Sec. 63.21(c)(7) 
in the final rule] does require that DOE's Safety Analysis Report 
include a description of its plans for the alternate storage of the 
radioactive wastes, should retrieval be necessary. Retrieved waste 
would need to be controlled in compliance with applicable regulations 
at the time of retrieval.

2.3  Performance Confirmation

    Issue 1: What is the objective of the performance confirmation 
program?
    Comment. DOE commented that the general requirements for 
performance confirmation at Sec. 63.131(a) and requirements for 
confirmation of geotechnical and design parameters at Sec. 63.132(a) do 
not reflect the Commission's risk-informed, performance-based approach 
to regulation because the requirements do

[[Page 55744]]

not explicitly focus the performance confirmation program on data 
linked to the performance assessment. DOE stated that the performance 
confirmation program, when tied to a performance-based approach, should 
focus on the verification of the performance assessment. DOE stated 
that this approach would allow DOE and NRC to focus attention and 
resources on those parameters and processes that are significant 
contributors to repository performance and to uncertainties in that 
performance.
    Response. The objective of the performance confirmation program is 
to confirm the assumptions, data, and analyses that led to the findings 
that permitted construction of the repository and subsequent 
emplacement of the wastes. Consistent with NRC's performance-based 
approach, the NRC will make findings with respect to each of the 
performance objectives in Part 63, Subpart E, and not just the 
postclosure performance objective specified at Sec. 63.113(b). The 
general requirements for the performance confirmation program at 
Sec. 63.131(a)(1) and (a)(2) state that the program must provide data 
that indicate whether: (1) Subsurface conditions encountered and 
changes in those conditions during construction and waste emplacement 
are within limits assumed in the licensing review and (2) natural 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. These 
requirements are intended to encompass subsurface conditions and design 
assumptions related to both operational (preclosure) and postclosure 
repository performance. Should the Commission authorize construction of 
a geologic repository at Yucca Mountain, the NRC staff will conduct an 
ongoing, performance-based inspection program to evaluate DOE's 
compliance with the performance objectives and any conditions 
established in that construction authorization per Sec. 63.75.
    The general requirements at Sec. 63.131(a) explicitly link the 
performance confirmation program to DOE's performance assessment, 
albeit in terms of the barriers designed or assumed to function after 
permanent closure. Although the primary focus of the performance 
confirmation program is on postclosure performance of the repository, 
and the NRC recognizes DOE's desire to focus on verifying the 
performance assessment (e.g., postclosure performance), it is important 
that the general requirements also include consideration of operational 
aspects of repository performance, for example, the ability to retrieve 
waste as required at Sec. 63.111(e). An organized program of collecting 
subsurface information during repository construction and operation 
that confirms the design assumptions regarding the ability to retrieve 
waste is therefore an important performance confirmation activity. The 
NRC believes that the general requirements at Sec. 63.131(a) allow DOE 
the flexibility to develop and implement an effective performance 
confirmation program focused on confirming assumed subsurface 
conditions and assumed functionality of geologic and engineered systems 
and components important to postclosure performance (i.e., performance 
of barriers important to isolation) and/or preclosure repository 
operations (e.g., retrievability). In the proposed rule, the definition 
of performance confirmation in Sec. 63.2 and the discussion of 
performance confirmation in Sec. 63.102(m) do not clearly reflect the 
intent of Sec. 63.131(a) and have been revised accordingly in the final 
rule. To adopt the changes to Secs. 63.131(a) and 63.132(a) requested 
by DOE would remove consideration of operational aspects of repository 
performance from the performance confirmation program. For these 
reasons, the Commission does not agree that these changes are 
appropriate and has not adopted them.
    Issue 2: Are the requirements for the performance confirmation 
program too prescriptive?
    Comment. Some commenters were concerned with the level of detail 
provided in the requirements for the performance confirmation program. 
NEI commented that the regulation should provide for ongoing programs 
of monitoring and testing to improve information but also stated that 
the specified requirements should be made less prescriptive. NEI stated 
that Secs. 63.132-134 (respectively, Confirmation of geotechnical and 
design parameters, Design testing, and Monitoring and testing waste 
packages) were inconsistent with the overall performance-based nature 
of the regulation. NEI recommended that these requirements be deleted 
because they are unnecessary and counterproductive to Sec. 63.131 in 
that they provide more detail and remove flexibility already in the 
rule. NEI also recommended minor word changes to the definition of 
performance confirmation in Sec. 63.2 and the discussion of performance 
confirmation in Sec. 63.102(m) to lessen the potential for overly 
prescriptive interpretations of what is expected of the performance 
confirmation program. DOE commented that the minimum list of 
geotechnical parameters in Sec. 63.132(c) is overly prescriptive and is 
not needed or appropriate. DOE recommended revising the requirement to 
state that DOE will determine the parameters, measurements, and 
observations appropriate for inclusion in the program. DOE also 
recommended revising Sec. 63.133, which restricted design testing to in 
situ testing, to allow performance of some of the design testing at 
other locations, such as laboratories, other test facilities, or 
boreholes outside of the repository block. In addition, DOE also 
suggested revising the wording of Sec. 63.133(c) to make it clear that 
testing of backfill is required only if backfilling the emplacement 
drifts is planned. Another commenter noted that while Sec. 63.134 
requires a program to monitor and test waste packages, the commenter 
found no statement of objectives or criteria for the monitoring and 
test program. The commenter was concerned that the regulation could be 
used to drive a very large and costly full scale test program and 
recommended that the objectives and criteria be stated.
    Response. The Commission agrees with the commenters that 
Secs. 63.132-134 were too prescriptive and has modified these sections 
accordingly. However, the Commission does not agree with the comment 
that Secs. 63.132-134 are inconsistent with the overall performance-
based nature of the rule and therefore should be deleted. The 
Commission believes the requirements for performance confirmation set 
forth in Secs. 63.132-134 are consistent with the overall performance-
based approach to part 63. Consistent with this approach, the rule does 
not prescribe specific subsystem requirements. The absence of subsystem 
requirements is a concern to a number of commenters. Some commenters 
believe that the rule places too much reliance on the total system 
performance assessment (refer to discussion of issues under Postclosure 
Safety Assessment and Multiple Barriers and Defense in Depth). The 
Commission believes these concerns are partly addressed through an 
effective performance confirmation program focused on confirming 
assumed subsurface conditions and assumed functionality of geologic and 
engineered systems and components important to postclosure performance 
and the related performance assessment. Specific concerns that these 
requirements are either too prescriptive or too limiting are discussed 
in the following paragraphs.
    Section 63.132 (Confirmation of geotechnical and design parameters)

[[Page 55745]]

provides additional requirements related to the underground facility 
including comparing the original design bases and assumptions to 
information obtained during construction and operation, determining 
their significance to performance, and reporting this information, 
including recommended design changes, to the Commission. Section 
63.132(c) does prescribe specific measurements and observations to be 
made by DOE. Because the design of the repository is evolving, it is 
not clear that, in the future, this list will be an acceptable minimum 
list of measurements and observations to be made. For the same reason, 
it is not clear that, in the future, all items in the list will be 
technically justifiable within the context of operational and 
postclosure performance of the repository. The Commission believes that 
it is DOE's responsibility to specify the important geotechnical and 
design parameters to be evaluated through observation and measurement 
during construction and operation, subject to NRC approval through 
review and evaluation of the license application. DOE will provide this 
information in their performance confirmation plan included in the 
license application. If necessary, the NRC staff will provide guidance 
to DOE in this area through pre-licensing interactions and/or the YMRP. 
Section 63.132(c) has been revised to reflect these considerations.
    Section 63.133 (Design testing) provides requirements for in situ 
testing of seals and backfill and the thermal interaction effects of 
waste packages, backfill, rock, and ground water. DOE's recommendation 
that Sec. 63.133 be revised so as to not limit testing to in situ 
testing only is reasonable. Section 63.133(a) has been revised 
accordingly. The NRC has also revised Sec. 63.133(a) to generally 
reference ``engineered systems and components,'' with examples, so as 
to not limit tests to specific features that may or may not be included 
in the final design of the repository. Finally, the Commission has 
revised Sec. 63.133(c) to require specific testing of the effectiveness 
of backfill placement and compaction only if backfill is included in 
the repository design.
    Section 63.134 (Monitoring and testing waste packages) provides 
specific requirements for monitoring and testing waste packages 
consistent with the objectives of the performance confirmation program 
established at Sec. 63.131(a). Waste packages are important engineered 
components designed to operate as barriers after permanent closure. 
Because the assumed long-term performance of waste package materials is 
based on short-term experimental data, monitoring waste package 
performance and related laboratory experiments are appropriate 
performance confirmation activities. Although the NRC recognizes the 
need for reasonable cost constraints, it is important to note that it 
is DOE's responsibility to develop the details of a performance 
confirmation plan that focuses on those natural and engineered systems 
and components important to repository performance and operation. The 
requirements allow DOE the flexibility to develop a focused and 
effective performance confirmation program. An alternative approach 
would be to prescribe in detail the specifics and limits of that 
program. The Commission does not want to limit DOE's options regarding 
testing methodologies and has chosen not to follow that approach. Note, 
however, that NRC will evaluate the adequacy of the performance 
confirmation program in the course of its review of the license 
application.
    Issue 3: Is the performance confirmation data required to be used 
in the updating of the performance assessment?
    Comment. EPA recommended that performance confirmation data should 
be explicitly identified as information to be included in the update of 
the performance assessment required at the time of the amendment for 
permanent closure [Sec. 63.51(a)(1)].
    Response. The Commission agrees with the commenter and has modified 
the rule accordingly.

2.4  Preclosure Operations Activities

    Issue: Should the proposed rule specify environmental monitoring 
requirements for regulating releases from the preclosure operational 
activities?
    Comment. The EPA commented that requirements for environmental 
monitoring during the operational phase of the repository were not in 
the proposed rule and there were no methods stated in the rule for 
enforcement of the preclosure requirements.
    Response. The Commission considers that proposed part 63 has 
sufficient requirements for environmental monitoring during the 
operational phase of the repository and is not revising the rule on 
this issue. The Commission has included environmental monitoring 
requirements for radioactive releases in part 63. Sections 63.111 and 
63.112 require DOE to account for, design against, and monitor any 
potential event sequences that could lead to radioactive releases. As 
part of the PSA (Sec. 63.112), for example, DOE is to describe its 
design and operating procedures for monitoring and controlling 
radioactive releases. Consistent with its National Environmental Policy 
Act (NEPA) responsibilities, DOE has already described its plans and 
procedures for the monitoring (and mitigation) of environmental impacts 
due to the operation of the geologic repository, including radioactive 
releases, in its DEIS for Yucca Mountain.
    Regarding the comment on the lack of enforcement methods in the 
rule, subpart J of part 63 addresses enforcement at a level of detail 
that the Commission has typically used in all its regulations. Specific 
policy and procedure issues for enforcement activities are described in 
NRC's ``General Statement of Policy and Procedure for NRC Enforcement 
Actions,'' the NRC enforcement manual, and supplemental guidance. The 
Commission believes this is an appropriate approach for its regulations 
and will retain the current language as in the proposed rule under 
subpart J. The Commission plans to develop specific changes to the 
enforcement policy and procedures as part of development of inspection 
and oversight plans for implementation of part 63.

2.5  Emergency Planning Criteria

    Issue 1: If local emergency first-responder capabilities and 
emergency medical services are not sufficient for reacting to nuclear 
accidents at the geologic repository, will the NRC require DOE to 
enhance existing local capabilities in the Yucca Mountain region?
    Comment. Commenters expressed concern that current local emergency 
and medical services are not adequate to respond to potential nuclear 
accidents at a geologic repository at Yucca Mountain. Accordingly, it 
was suggested that NRC include, as a license condition to operate the 
repository, a requirement that DOE enhance local capabilities for 
responding to potential nuclear accidents.
    Response. Part 63 (Subpart I) requires DOE to submit an emergency 
plan for coping with radiological accidents. NRC's review of DOE's 
emergency plan will evaluate the adequacy of the plan including such 
things as the capability to respond to accidents and medical assistance 
for treatment of radiological injuries. Where DOE's emergency plan is 
found to be inadequate, the NRC, if necessary, can impose license 
conditions that require DOE to correct any deficiencies. (See also 
response to Issue 3 below.)

[[Page 55746]]

    Additionally, U.S. Federal Emergency Management Agency (FEMA) 
regulations, as well as DOE orders, require that DOE have an emergency 
response capability that is adequate to meet anticipated accidents, 
including potential radiological accidents. DOE is responsible for 
ensuring that the emergency treatment capability exists and is 
documented in its emergency plan, which is subject to NRC review in 
accordance with Sec. 63.161.
    Issue 2: Will DOE's emergency plans be sufficiently comprehensive 
to include such scenarios as emergency evacuation procedures and 
responses to terrorist activity?
    Comment. Some commenters were concerned whether DOE would have 
adequate, effective, and sufficiently comprehensive plans and 
procedures to address most, if not all, potential accidents, incidents, 
and/or contingencies.
    Response. The rule requires DOE to have plans to cope with 
radiological accidents (emergency planning at Sec. 63.161) and provide 
for physical protection (Sec. 63.21(b)(3)). These plans are required to 
address a number of criteria to ensure that DOE is prepared to respond, 
both on site and off site, to accidents, and that DOE has the 
capability to detect and respond to unauthorized access and activities 
that could threaten the physical protection of HLW. As noted in the 
previous response, NRC and FEMA regulations, as well as DOE orders, 
require that DOE have adequate plans and procedures in place to address 
any potential accidents and incidents. DOE's emergency plan and 
physical protection plan are subject to NRC review. The Commission 
believes that the requirements for DOE's plans for emergencies and 
physical protection expressed in the proposed part 63 are appropriate 
and has retained them in the final rule. In light of the terrorist 
attacks of September 11, 2001, the Commission has directed the staff to 
conduct a comprehensive reevaluation of NRC physical security 
requirements. If this effort indicates that NRC's regulations or 
requirements warrant revision, such changes would occur through a 
public rulemaking or other appropriate methods.
    Section 63.161 requires DOE to develop an emergency plan based on 
the criteria of Sec. 72.32 (i.e., criteria provided for an Emergency 
Plan for an Independent Spent Fuel Storage Installation (ISFSI)). The 
required Emergency Plan includes: Identification of each type of 
accident, description of the means of mitigating the consequences of 
each type of accident; prompt notification of offsite response 
organizations; and adequate methods, systems, and equipment for 
assessing and monitoring actual or potential consequences of a 
radiological emergency condition. If particular types of accidents 
require evacuation procedures to ensure the protection of public health 
and safety, they will be included in the Emergency Plan.
    Section 63.21(b)(3) requires DOE to submit a detailed plan to 
provide physical protection of HLW in accordance with Sec. 73.51 
(requirements for physical protection of stored spent nuclear fuel and 
HLW). The requirements for physical protection include: (1) 
Capabilities to detect and assess unauthorized access or activities and 
protect against loss of control of the facility; (2) limiting access to 
HLW by means of two physical barriers; (3) providing continual 
surveillance of the protected area in addition to protection by an 
active intrusion alarm; and (4) providing a primary alarm station 
located within the protected area and have bullet-resisting walls, 
doors, ceiling, and floor. These requirements provide high assurance 
that physical protection of the repository includes appropriate 
measures to prevent and respond to unauthorized access and activities, 
including the potential for armed intruders (e.g., terrorist activity).
    Issue 3: Will Federal funding be available to upgrade emergency 
first-responders and emergency medical services so as to allow local 
communities to be better prepared to respond to potential 
transportation accidents?
    Comment. Counties in the Yucca Mountain region expressed concern 
with their ability to respond to medical emergencies resulting from a 
transportation accident involving nuclear waste. Local communities 
suggested that DOE be required to enhance local emergency capabilities 
for responding to transportation accidents.
    Response. Section 180(c) of the NWPA requires DOE to provide 
technical assistance and funding for training State and local 
governments and Tribes for safe routine transportation and emergency 
response. However, NRC's responsibility for oversight and review of 
DOE's emergency plans (see discussion under Issues 1 and 2) does not 
include responsibility for how DOE provides for technical assistance 
and funding. Additionally, under NEPA, the potential for 
(environmental) impacts due to transportation, including accidents, is 
the responsibility of DOE to assess and mitigate.

3  Requirements for the Postclosure Period

3.1  Postclosure Safety Assessment

    Issue 1: Can performance assessments be relied on as the sole 
quantitative technique for evaluating compliance with postclosure 
safety requirements?
    Comment. DOE and NEI supported the risk-informed, performance-based 
approach. Additionally, NEI supported requirements in proposed Part 63 
intended to ensure that DOE conducts and documents a high-quality 
performance assessment (e.g., features, events, and processes (FEPs) be 
described; relevant conceptual models be considered) and NEI also 
expressed a need for the NRC to effectively and clearly articulate this 
approach in future regulatory efforts. However, other commenters 
indicated that, although performance assessment is a highly informative 
methodology, its capability to model complex, coupled geologic systems 
over extended time periods has yet to be demonstrated. Confidence in 
performance assessments could be improved through testing on actual 
geologic systems and conducting suitable, long-term studies.
    Response. Although repository postclosure performance is evaluated 
with respect to a single performance measure for individual protection, 
the NRC considers a broad range of information in arriving at a 
licensing decision. In the case of the proposed repository at Yucca 
Mountain, Part 63 contains a number of requirements (e.g., qualitative 
requirements for data and other information, the consideration and 
treatment of uncertainties, the demonstration of multiple barriers, 
performance confirmation program, and QA program) designed to increase 
confidence that the postclosure performance objective is satisfied. The 
Commission will rely on the performance assessment as well as DOE's 
compliance with these other requirements in making a decision, if DOE 
submits a license application for disposal of HLW at Yucca Mountain. 
The Commission believes the approach for performance assessment in the 
proposed rule is appropriate and it is retained in the final rule. 
However, requirements for QA, multiple barriers, and performance 
confirmation have been revised to clarify the Commission's intent for 
these requirements (see discussion under Quality Assurance, Multiple 
Barriers and Defense in Depth, and Performance Confirmation for more 
details).
    The Commission believes that there have been significant advances 
in, and experience with, risk assessment in the

[[Page 55747]]

past 20 years (see Commission's white paper on Risk-Informed and 
Performance-Based Regulation, March 1999). The Commission continues to 
believe that a performance assessment, developed with sufficient 
credibility, is the best means to provide useful information to the 
Commission for making an informed, reasonable licensing decision. The 
Commission recognizes, however, the uncertainties inherent in 
evaluating a first-of-a-kind facility like the repository and in 
estimating system performance over very long time periods (i.e., 10,000 
years). Thus, proposed part 63 contained requirements to ensure that: 
(1) Uncertainties inherent in any performance assessment are thoroughly 
articulated and analyzed or addressed; (2) DOE's performance assessment 
is tested (corroborated) to the extent practicable; and (3) there are 
additional bases, beyond the performance assessment, that provide 
confidence that the postclosure performance objectives will be met. For 
example:
1. Requirements for Addressing Uncertainty in Performance Assessment
    Section 63.114 provides a number of requirements for DOE's 
performance assessment to thoroughly address uncertainty. Part 63 
requires consideration of uncertainties in DOE's representation of the 
repository (uncertainty and variability in parameter values must be 
taken into account--Sec. 63.114(b)) and the events that can happen 
during the compliance period (consideration of potentially disruptive 
events with a probability of occurrence as low as one chance in 10,000 
of occurring over 10,000 years--Sec. 63.114(d)) to be directly included 
in the quantitative estimate of performance. Additionally, DOE is 
required to provide additional assurances that uncertainty in the 
information (e.g., evaluation of site characterization data) used to 
develop the performance assessment have been evaluated by consideration 
of alternative conceptual models of features and processes that are 
consistent with available data and current scientific understanding 
(Sec. 63.114(c)); and the basis for inclusion or exclusion of FEPs that 
would have a significant effect on performance (Sec. 63.114(e) and 
(f)). (See discussion under Issue 2 for further details on uncertainty 
in performance assessment.)
2. DOE's Performance Assessment Is Tested (Corroborated) to the Extent 
Practicable
    DOE must test or corroborate, to the extent practicable, the 
confidence in (validity of) the performance assessment models. Part 63 
requires DOE to provide the technical basis for the models used in the 
performance assessment (Sec. 63.114(g)). Approaches for providing the 
technical basis would include comparisons of these models with 
information relevant to the conditions of geologic disposal and time 
periods of the assessment (e.g., results from detailed process-level 
models, field investigations, and natural analogs). Additionally, a 
performance confirmation program is required (part 63, subpart F) to 
confirm that the behavior of the barriers of the repository system is 
consistent with what has been assumed in the performance assessment 
(see discussion under Performance Confirmation for more details).
3. Basis for Confidence That the Postclosure Performance Objectives 
Will Be Met
    As a basis for confidence that the postclosure performance 
objectives will be met, the Commission plans to rely on requirements in 
addition to that for the performance assessment. Specifically, part 63 
requires a multiple barrier approach for the repository, and a QA 
program. A requirement that multiple barriers make up the repository 
system ensures that repository performance is not wholly dependent on a 
single barrier. As a result, the system is more tolerant of failures 
and external challenges such as disruptive events (see discussion under 
Multiple Barriers and Defense in Depth for more details). The required 
QA program enhances confidence in the design and characterization of 
barriers important to waste isolation.
    In summary, any determination that the postclosure performance 
objectives will be met will be based on a comprehensive set of 
regulatory requirements. Thus, reliance on the performance assessment 
for assisting regulatory decisions is supported by a range of 
considerations. The Commission believes this comprehensive approach 
(i.e., requirements for addressing uncertainty, providing technical 
basis for models, and additional requirements, beyond expected 
performance, for increasing confidence that the performance objectives 
will be met) is appropriate and it is retained in the final rule.
    Issue 2: Should a requirement for the level of uncertainty and 
performance that is acceptable for performance assessment of the 
proposed repository be included in part 63?
    Comment. A number of comments were received concerning uncertainty 
in estimating postclosure performance of the repository. Commenters 
were concerned with the level or degree of uncertainty in performance 
calculations and approaches for analyzing uncertainty in performance 
calculations. Some specific concerns were: (1) The acceptable level of 
uncertainty should be clearly stated in part 63 (results that depend 
mainly on assumptions rather than actual properties are unacceptable); 
(2) the many orders of magnitude of uncertainty in performance 
projections are, and will continue to be, too high for assuring long-
term safety; and (3) whether DOE is required to predict ``actual'' 
performance.
    Response. The first-of-a-kind nature of the repository and the 
evaluation over a very long time period result in significant 
uncertainty being included in the performance assessment. Part 63 not 
only requires DOE to account for uncertainty in its performance 
assessment but also contains a number of other requirements (e.g., use 
of multiple barriers, performance confirmation program) to compensate 
for residual uncertainties in estimating performance. The Commission 
will consider all these requirements in determining whether it has 
sufficient confidence (i.e., reasonable expectation) that DOE has 
demonstrated or has not demonstrated the safety of the repository. 
Specification of an acceptable level of uncertainty is neither 
practical nor appropriate due to the limited knowledge currently 
available to support any such specification and the range of 
uncertainties that would need to be addressed. The Commission believes 
the approach to performance assessment in the proposed rule, which 
includes the treatment of uncertainty, is appropriate and has retained 
this approach in the final rule.
    The previous response under Issue 1, discussed the requirements for 
the performance assessment. Many of these requirements address 
uncertainty in the performance assessment. Some of these uncertainties 
will be directly included in the DOE's estimate of performance. For 
example, DOE is expected to conduct uncertainty analyses (i.e., 
evaluation of how uncertainty in parameter values affects uncertainty 
in the estimate of dose), including the consideration of disruptive 
events and associated probability of occurrence. Other uncertainties 
are not necessarily quantified but are considered during the 
development of the conceptual models for the performance assessment 
(e.g., consideration of alternative models, inclusion and exclusion of 
FEPs). If NRC were to specify an acceptable level of uncertainty, the 
specified value would be somewhat arbitrary because:

[[Page 55748]]

(1) Understanding of the site is evolving as site studies continue; (2) 
repository design options are still being evaluated; and (3) 
differences in the types of uncertainties (e.g., variability in 
measured parameters, modeling assumptions, expert judgment, etc.) 
complicate the specification. The approach defined in part 63, which 
requires DOE to fully address uncertainties in its performance 
assessment rather than requiring DOE to meet a specific level of 
uncertainty, is appropriate. The treatment of uncertainty in DOE's 
performance assessment will be an important part of NRC's review.
    Regardless of the uncertainty in the performance assessment, part 
63 contains additional provisions to increase confidence that the 
postclosure performance objectives will be met. These provisions 
include requirements for multiple barriers, a performance confirmation 
program, and implementation of a QA program (see discussion under Issue 
1). However, it should be kept in mind that the performance assessment 
evaluates ``potential'' doses, not ``actual'' doses. For example, part 
63 requires the performance assessment to assume for the next 10,000 
years that the reasonably maximally exposed individual (RMEI) is a 
member of a community that: (1) Exists where it will intercept 
potential releases from the repository and (2) uses ground water but 
never tests the quality of this water nor treats the ground water to 
remove any contaminants. This specification is considered appropriately 
conservative for evaluating performance but most likely is not an 
``accurate'' prediction of what will happen during the next 10,000 
years (see discussion under RMEI Characteristics and Reference 
Biosphere for more information on the RMEI). Although the Commission 
does not require an ``accurate'' prediction of the future, uncertainty 
in performance estimates cannot be so large that the Commission cannot 
find a reasonable expectation that the postclosure performance 
objectives will be met (see discussion under Reasonable Expectation). 
At this time, the Commission is not aware of any information that 
suggests the uncertainties are so large that NRC will be unable to make 
a regulatory decision regarding the safety of a potential repository at 
Yucca Mountain.
    Issue 3: Do known conditions at the Yucca Mountain site and/or the 
potential for other adverse conditions make Yucca Mountain an 
unacceptable location for an HLW repository?
    Comment. Commenters expressed opinions/concerns regarding the 
impact of certain FEPs (e.g.; Yucca Mountain lies in an area that is 
seismically and tectonically active; volcanic activity in the recent 
geologic past; potential for fast ground-water pathways to the water 
table; the effect of heat and radiation on the surrounding rock; 
microbial-induced corrosion of the waste package; and the potential for 
a significant rise of the water table as the water table may rise and 
interact with the proposed repository) that could have a deleterious 
effect on repository performance. Given these concerns, many of the 
commenters recommended the Yucca Mountain site be withdrawn from 
further consideration as a potential repository.
    Response. Consideration of all FEPs, especially those with the 
potential to have an adverse effect on performance, is an important 
part of the evaluation of repository performance. Commenters have 
correctly identified a number of conditions that have been or are being 
considered by DOE in performance assessments for Yucca Mountain, such 
as seismic activity, thermal effects, volcanic activity, microbial-
induced corrosion of the waste package, and the potential for a 
significant rise of the water table. Section 63.114 requires DOE to 
consider all FEPs pertinent to a repository at Yucca Mountain and fully 
justify how they are treated in the performance assessment. In 
reviewing DOE's performance assessment, the NRC will evaluate how well 
DOE has accounted for those FEPs that could have an adverse effect on 
the repository. Based on current information, the Commission is not 
aware of any specific feature, event, or process that so adversely 
affects repository performance that Yucca Mountain must be withdrawn 
from further consideration by DOE as a potential repository site.
    Issue 4: How will NRC ensure DOE properly documents its performance 
assessment?
    Comment. One commenter discussed the need for DOE to provide a 
traceable and transparent analysis in support of its demonstration of 
compliance with the performance standard. The commenter recommended 
that plain English should be used to document the performance 
assessment to improve overall understanding of the risks.
    Response. The Commission agrees that DOE's performance assessment 
needs to be clearly documented. Part 63 provides the requirements for 
DOE's performance assessment at Sec. 63.114 and requirements for the 
content of the application at Sec. 63.21. These requirements provide a 
general description of the types of information that need to be 
included in the license application but do not prescribe specific 
details for the format of the documentation. The Commission believes it 
is inappropriate and unnecessary to prescribe, in the regulations, 
further details for DOE's documentation. The performance assessment is 
DOE's analysis, and DOE needs flexibility in deciding how best to 
document its analysis. However, the NRC staff is developing a YMRP to 
provide guidance to DOE on approaches for documenting performance 
assessment results that are both transparent and traceable. The 
Commission agrees with improving overall understanding of performance 
assessment through better documentation and will interact with the 
public and DOE to improve the YMRP in this important area.
    Issue 5: Why does NRC require DOE to evaluate alternative designs?
    Comment. DOE questioned the regulatory basis of Sec. 63.21(c)(7) 
that requires DOE to evaluate alternative designs. DOE believes 
evaluation of alternative designs goes beyond typical licensing 
practice by implying a need for DOE to justify selection of one design 
over another. DOE suggested they should be allowed to select the design 
that best suits their purposes consistent with the approach given other 
NRC-regulated activities at Sec. 50.109(a)(7). Another commenter 
suggested that the consideration of alternative designs be limited to 
present-day technology.
    Response. The Commission agrees with the comments and has removed 
this requirement from the regulations. The NRC review should focus on 
the safety aspects of DOE's proposed approach. DOE should only be 
required to propose alternatives from its proposed approach in areas 
where the NRC review determines DOE's approach is deficient.
    When developing proposed part 63, the NRC staff adopted this 
requirement from 10 CFR part 60, the existing generic NRC HLW disposal 
regulation, which contains a similar requirement in 10 CFR 60.21 
(c)(1)(ii)(D). At the time of the issuance of part 60, DOE objected to 
this specific requirement with basically the same argument presented 
for part 63. In the Statement of Considerations for part 60 (published 
in Federal Register on June 21, 1983; 48 FR 28194), the Commission 
justified the requirement by stating ``If the Commission finds, on the 
basis of its review, that the adoption of some alternative design 
feature would significantly increase its confidence that the 
performance objectives would be

[[Page 55749]]

satisfied, and that the costs of such an approach are commensurate with 
the benefits, it should not hesitate to insist that the alternative be 
adopted.''
    The decision to require DOE to submit alternatives for certain site 
design features was a discretionary action on the part of the 
Commission as nothing (in either the Atomic Energy Act of 1954, as 
amended, or the Nuclear Waste Policy Act of 1982, as amended) required 
the Commission to obtain information on alternative designs at the site 
level. At the time part 60 was initially published (1983), the 
Commission implemented an appropriate regulatory framework for a 
generic program facing many uncertainties. Multiple sites with very 
different geological settings were under consideration. The NRC's 
generic HLW regulations had to address the resolution of a large number 
of technical issues in the relative short licensing review period 
established by the Nuclear Waste Policy Act of 1982. With all the 
uncertainties in the program, the Commission believed it was important 
to require design alternatives be submitted with the application to 
increase the probability of NRC approval of the license application 
within the three-year schedule mandated by Congress.
    The Commission has revisited the decision to require submission of 
alternative designs. Specifically, the Commission no longer believes 
this information should be submitted with a license application and, 
accordingly, has removed this requirement. To protect public health and 
safety and the common defense and security, which is the NRC's mandate 
under the Atomic Energy Act of 1954 as amended, the Commission will 
closely scrutinize the design proposed by DOE. Consistent with this 
mandate, the new part 63 is designed to be a risk-informed, 
performance-based regulation which establishes overall repository 
performance objectives. DOE must demonstrate that the repository meets 
the performance objectives. The NRC review is an audit of the DOE 
demonstration to determine if we agree that the performance objectives 
have been met. If the NRC believes that the site does not meet the 
performance objectives within uncertainties addressed in the analysis, 
then it is DOE's responsibility to either defend its current design or 
propose an alternative design that can meet the NRC acceptance 
criteria.

3.2  Individual Dose Limit

    Issue 1: How is the protection of future generations considered as 
part of setting the dose limit?
    Comment. A number of commenters expressed concern that the dose 
limit specified in the proposed rule provided inadequate protection for 
future generations. Commenters suggested that (1) selection of the dose 
limit should consider the unpredictability of the future, particularly 
where and how an individual would be exposed, and (2) the dose limit 
should reflect impacts from either future energy development or past 
releases on the local community, such as ground-water releases from the 
NTS or the Beatty Low-Level Waste facility, in developing the standard.
    Response. The purpose of the postclosure dose limit and the 
performance assessment is to ensure that future generations will be 
adequately protected. EPA has established, and the Commission has 
incorporated, an individual dose limit of 0.15 mSv/year (15 mrem/year). 
The Commission is confident that this limit is fully protective and 
that it provides an added margin of safety beyond what is necessary to 
ensure public health and safety. The Commission has long held that an 
individual dose limit of 0.25 mSv/year (25 mrem/year) TEDE is (1) a 
reasonable and appropriate level of protection for future generations, 
(2) within the range of dose limits used for current sources of public 
exposure, and (3) accounts for the possibility of dose from other 
sources.
    In judging the adequacy of a dose limit for waste management and 
other related activities, NRC considers recommendations from the 
International Commission on Radiological Protection (ICRP), National 
Council on Radiation Protection and Measurements (NCRP), EPA, and 
International Atomic Energy Agency (IAEA). The ICRP's and NCRP's 
recommendations are developed by recognized experts in the fields of 
radiation protection and health effects. The NCRP is a nonprofit 
corporation chartered by the U.S. Congress to develop and disseminate 
information and recommendations about radiation protection and to 
cooperate with the ICRP and other national and international 
organizations with regard to these recommendations. The ICRP is an 
international panel of radiation experts from all fields that provides 
estimates of radiation risk and recommendations on radiation protection 
and has continued to update and revise its risk estimates and radiation 
protection recommendations since its inception in 1928. In its 
deliberations, ICRP maintains relationships with United Nations health 
and labor organizations.
    The IAEA is a United Nations agency involved in assisting member 
states to establish consistent radiation protection standards. In 1995, 
the IAEA identified a number of principles with the express purpose of 
giving a common basis for the development of more detailed standards 
and a basis for national waste management programs (The Principles of 
Radioactive Waste Management, IAEA Safety Series No.111-F, 
International Atomic Energy Agency, Vienna (1995)). Two of the 
principles are:
    1. Protection of Future Generations. Radioactive waste shall be 
managed in such a way that predicted impacts on the health of future 
generations will not be greater than the relevant levels of impact that 
are acceptable today.
    2. Burdens on Future Generations. Radioactive waste shall be 
managed in such a way that will not impose undue burdens on future 
generations.
    In support of the proposed part 63 dose limit, the NRC considered 
other current regulations for consistency and the potential effects of 
other sources of radiation to select a limit that would be acceptable 
today for releases of radiation. The EPA, ICRP, and NCRP have all 
supported the use of source-specific constraints (i.e., a margin of 
safety) below the 1 mSv/year (100 mrem/year) public dose limit to 
account for the potential effect of multiple sources of radiation 
exposure. In addition, use of the critical group concept or the RMEI 
provides an additional margin of safety because it is difficult for the 
same individual to be a member of the critical group or to be the RMEI 
for multiple diverse sources.\1\ The final regulations, which specify 
use of the RMEI concept and limit individual dose to 0.15 mSv/year (15 
mrem/year) (15% of the public dose limit), are sufficiently protective 
that potential exposures from other sources (e.g., past releases from 
operations at NTS and future hospitals or research centers) would not 
be expected to result in exposures above the 100 mrem/year public dose 
limit.
---------------------------------------------------------------------------

    \1\ Although an individual might be exposed to more than one 
source of radiation, it would be a very rare circumstance for that 
individual to retain the lifestyle and other characteristics of the 
RMEI for more than one source.
---------------------------------------------------------------------------

    Issue 2: Why does NRC prefer an individual dose limit over a total 
release limit like part 60?
    Comment. Some commenters, while noting that the EnPA specified a 
dose limit for Yucca Mountain, expressed their support for a total 
release limit like

[[Page 55750]]

part 60. The commenters believed that a total release limit is more 
understandable, easier to implement, and a simpler way to measure 
compliance of the repository's performance.
    Response. The EPA has established a dose limit for individual 
protection, expressed in terms of a limit on dose to the RMEI. The NRC 
is incorporating this limit as required by law. A total release limit 
may appear to be more straightforward and understandable. In fact, 
however, nearly all of the same issues, such as dose or risk limit, 
human behavior, or volume of water mixed with the release, must be 
addressed to determine an appropriate release standard that is 
protective of the health and safety of the public and environment. 
Furthermore, a release standard is more difficult to relate directly to 
site-specific risk.
    To set a release limit, the regulatory agency would first need to 
establish a risk or dose goal and calculate the risk or dose per unit 
release (e.g., per curie). The risk/dose goal would need to be the 
collective risk/dose over the entire compliance time for any release 
into the environment based on some assumed level of waste (e.g., for 40 
CFR part 191, EPA used a risk goal of 1,000 premature cancer deaths in 
10,000 years per 100,000 metric tons of heavy metal contained in spent 
fuel (High-Level and Transuranic Radioactive Wastes: Background 
Information Document for Final Rule, Office of Radiation Programs, EPA 
520/1-85-023, August 1985, Page 7-13)). To calculate the risk per unit 
release, a model estimating the individual dose from a release will 
need to be used. To develop the model and data parameters, assumptions 
about the type of release (e.g., for 40 CFR part 191, a release to 
surface water was assumed (ibid, pg. 7-13)), which biosphere processes 
to include, resource usage by the local population (e.g., for 40 CFR 
part 191, 65 percent of drinking water is assumed to be from the 
contaminated surface water (ibid, pg. 7-7)), and individual habits and 
characteristics (e.g., for 40 CFR part 191, annual individual intake of 
drinking water is assumed to be 600 liters (ibid, pg. 7-7)) will need 
to be made. In its current form, part 63 requires all the same 
calculations to be done, but the defense of many of the assumptions is 
the responsibility of DOE and will be subject to review and approval by 
NRC.
    Use of a release limit also provides less information than 
calculating the dose from a release. The dose calculation combines the 
intake and exposure from all radionuclides in the environment into one 
term. The dose from one scenario or calculation can be readily compared 
to another. When release limits are used, it is very difficult to 
compare results if more than one radionuclide is involved because each 
radionuclide provides a different dose/risk per unit activity. For 
example, consider a review of two alternate designs. For design number 
one, the total release results in radionuclide A being released at 60 
percent of its limit and radionuclide B is at 30 percent of its limit. 
For design number two, radionuclide A is 20 percent of its limit and 
radionuclide B is 70 percent of its limit. Without knowing the relative 
risk from a release per unit activity for each radionuclide, it would 
be difficult, if not impossible, to state which design results in a 
lower risk to the public. Thus, the total release limit yields less 
information in its application than a dose limit.
    Issue 3: How does the use of an individual dose limit protect the 
entire population?
    Comment. A few commenters supported either the use of collective 
dose limits or requiring dose distributions over the population to be 
calculated based on a concern that a single dose limit requiring only 
calculation of dose to the critical group would not adequately protect 
the overall population. Commenters: (1) Suggested that the collective 
dose is more important than the individual dose, (2) disagreed with the 
use of a negligible individual dose value to screen possible release 
scenarios, and (3) viewed a dose distribution over the population as 
more informative to the regulators and public, allowing a more risk-
informed decision to be made.
    Response. The Commission agrees with NAS that ``a health-based 
individual standard will provide a reasonable standard for protection 
of the general public'' (p. 65 of the NAS report). The final 
regulations, which specify characteristics of an RMEI and an individual 
dose limit of 0.15 mSv/year (15 mrem/year), are protective of the RMEI. 
The general public includes the small number of individuals within the 
RMEI's community as well as all other individuals residing near the 
Yucca Mountain area. Because the community in which the RMEI resides 
will have a higher estimated dose than the highest exposed individual 
who does not live in that community, an individual dose limit for the 
RMEI is protective of all individuals.
    Although a distribution of individual doses for the entire 
population arguably can provide more information to consider in making 
a decision, the speculation and uncertainty regarding a representative 
population dose distribution would generally make the results 
inadequate to use in decision making. The difficulty lies in developing 
the habits, characteristics, location, and exposure time for the entire 
population. For analyses of possible future releases, such as from 
degrading waste in Yucca Mountain, the assumptions about the location, 
habits, and characteristics for each individual (or group of 
individuals) would be speculative. The Commission believes that it is 
possible to develop and defend a reasonable exposure scenario for a 
small group of individuals that would likely receive the largest doses 
based on current practices in the region because analyzing doses 
received by the RMEI living in a community at the 18-km (11-mile) 
location with a diet and living style representative of the people who 
now reside in the Town of Amargosa Valley, Nevada, would bound any 
doses received by other individuals in the population. Because of the 
uncertainty in the distribution and range of activities, including 
location and number of individuals, for other less exposed groups, 
unbounded speculation could make any resulting population dose 
distribution unsupportable.
    Although the Commission could require performance assessments of 
the potential dose distribution to hypothetical individuals, at the 
same locations and with the same habits as the current residents, the 
Commission believes that the uncertainty in the doses calculated for 
those not subject to the largest expected exposures would make the 
results difficult to interpret. In the end, the speculation would lead 
NRC, DOE, EPA, and other interested parties to expend resources without 
a commensurate increase in public health and safety or protection of 
the environment.
    Collective dose is useful for comparing options but it does not 
provide adequate protection of the individual. Collective dose is the 
total dose received by all exposed people, regardless of distance or 
magnitude of exposure, over all time from a source. In general, most 
analyses tend to truncate the dose by calculating over a certain time 
frame and a given environmental area. Truncated collective dose can 
provide an overall measure of radiological impact on society or on 
parts of society but is only useful as an aid to compare options (e.g., 
DOE has considered individuals living within 84 km (52 miles) of the 
Yucca Mountain site for evaluating population doses in the DEIS). 
Because the calculation of collective dose results in a single value 
(in person-Sv (person-rem)), it gives no

[[Page 55751]]

indication of the range or variability of individual doses or the time 
when the doses could occur. Meanwhile, the use of an individual dose 
limit to the RMEI assures that the vast majority of the population 
receive lower doses. The Commission believes that using an individual 
all-pathway dose assessment provides to the regulator and the public a 
meaningful measure for making decisions regarding public health and 
safety.
    Issue 4: How is the ``As Low As Reasonably Achievable'' (ALARA) 
principle incorporated in part 63?
    Comment. A few commenters suggested that the ALARA principle be 
explicitly part of the long-term compliance dose limit in part 63. 
Others supported the proposed rule for not including the ALARA 
principle in the requirements for the long-term performance 
requirements because the cost-benefit analysis would be highly 
speculative.
    Response. The Commission believes that, although it is appropriate 
to explicitly require the application of the ALARA principle to the 
operational and decommissioning phases of the repository, the 
application of ALARA to achievement of the long-term performance 
objective is not appropriate.
    The ALARA principle deals with optimizing the reduction of 
potential doses from radiation to members of the general public and 
workers. It is a principal component of the radiation protection 
philosophy during operations and decommissioning activities and it 
helps to ensure that no individual will receive a dose in excess of the 
annual dose limit (i.e., 1 mSv/year (100 mrem/year) for the public and 
50 mSv/year (5,000 mrem/year) for radiation workers). Application of 
ALARA during operations compels the consideration of the benefits of 
further reduction in potential doses to present-day populations and 
workers relative to impacts to present-day populations (e.g., increased 
cost to reduce potential doses further). The application of ALARA to 
the achievement of the postclosure performance objective would involve 
considerations far more complicated than those evaluated for 
operations. The reasonableness of further reduction of potential doses 
would need to evaluate benefits and impacts that span many generations 
(e.g., costs incurred today versus a reduction of potential doses 
thousands of years in the future; repository designs that reduce 
potential doses in the future but increase doses to present-day workers 
during fabrication of the design such as installing a special 
backfill). By adopting the EPA's dose limit for long-term performance, 
the Commission implements a constraint that is a small fraction (15 
percent) of the public dose limit, and which provides a significant 
margin of safety to ensure that public health and safety and the 
environment are protected.
    In its 1995 findings and recommendations, NAS noted that there is 
no scientific basis for incorporating the ALARA principle into NRC's 
Yucca Mountain regulations. In summary, their reasoning was that deep 
geologic disposal, by its very nature, was ALARA, and there were few 
technological alternatives in repository design. They also noted it 
would be problematic to evaluate compliance with the application of 
ALARA principles in the postclosure phase of the repository. The 
Commission agrees with NAS in this regard. Therefore, although the 
Commission will require ALARA considerations for the operational phase 
and decommissioning of the surface facilities, NRC will not explicitly 
require an ALARA analysis as part of the postclosure performance 
assessment.
    Issue 5: Why did NRC select 0.25 mSv/year (25 mrem/year) as the 
proposed dose limit?
    Comment. A large number of commenters addressed the 0.25 mSv/year 
(25 mrem/year) dose limit in proposed part 63. A large number either 
disagreed with the limit, saying it was too high, or supported a lower 
standard such as the EPA's 0.15 mSv/year (15 mrem/year) standard in 40 
CFR part 191 and proposed 40 CFR part 197. Some commenters (1) 
expressed confusion on whether the dose limit was for workers or 
members of the public, (2) requested additional clarification on what 
``fully protect'' meant as part of the dose limit, or (3) supported the 
0.25 mSv/year (25 mrem/year) dose limit.
    Response. The purpose of the postclosure dose limit and the 
performance assessment is to ensure that future generations will be 
adequately protected. EPA has established, and the Commission has 
incorporated, a dose limit of 0.15 mSV/year (15 mrem/year). The 
Commission has long held that its proposed dose limit of 0.25 mSv/year 
(25 mrem/year) to an individual is (1) a reasonable and appropriate 
fraction of the annual public dose limit to protect future generations 
from receiving doses greater than 1 mSv/year (100 mrem/yr), (2) within 
the range of dose limits used for current sources of public exposure, 
and (3) accounts for the possibility of dose from other sources. 
However, the Commission has changed the dose limit in the final rule 
because it is required to be consistent with EPA's final standards, and 
not because the Commission is persuaded that its earlier proposal is 
unsafe, inadequate, or not appropriate in any way. The Commission is 
confident that the 0.15 mSv/yr (15 mrem/yr) limit is also amply 
protective. Both limits ensure that no member of the public would be 
exposed to more than 1 mSv/yr (100 mrem/yr) from all sources of 
radiation, except background radiation. Both protect future 
generations. During the operational phase, the repository will be 
required to comply with part 20 for worker and public health and 
safety, except that the permitted public dose will be limited to 0.15 
mSv/yr (15 mrem/yr).
    Issue 6: How is NRC's proposed limit different than the dose limits 
in older rules (i.e., part 61) and how do they compare?
    Comment. Many commenters were concerned that the proposed part 63 
would relax health and safety standards. They (1) disagreed with the 
comparisons with other waste-related safety standards discussed in the 
Statements of Consideration of the proposed rule, especially with rules 
using an older dose methodology and (2) expressed concern that the use 
of the single limit on the TEDE did not adequately protect the organs. 
They pointed to regulations requiring specific organ limits. While not 
a dose limit, some commenters disagreed with the use of the national 
value for background radiation for comparison for the Nevada area 
because of impacts from past practices.
    Response. Part 63 does not change the 1 mSv/yr (100 mrem/yr) public 
dose limit from part 20, which is the health and safety standard for 
protection of members of the public. The Commission adopts, in part 63, 
a limit specifically for the repository that is well below the public 
dose limit, and that is similar to, but more stringent than a number of 
other waste management-related dose limits. As noted in the proposed 
rule, the Commission considers 0.25 mSv/yr (25 mrem/yr) TEDE to be the 
appropriate dose limit to compare with the range of potential doses 
represented by the older limits that had whole body dose limits of 0.25 
mSv/yr (25 mrem/yr). The single limit does account for each organ's 
sensitivity to radiation, and each organ is limited to the same risk as 
the whole body.
    Different sources of radiation can have different constraints 
placed on them. The 0.25 mSv/yr (25 mrem/yr) dose limit is in a similar 
range as a number of other constraints for waste management facilities 
or

[[Page 55752]]

decommissioning requirements (e.g., 40 CFR 191.03(a), 10 CFR 72.104, 10 
CFR 61.41, and 10 CFR 20.1402). Furthermore, during the operational and 
surface facility decommissioning phases, the facility will need to meet 
the ALARA requirements in 10 CFR 20.1101(b). This includes an 0.1 mSv/
yr (10 mrem/yr) additional constraint on air emissions (10 CFR 
20.1101(d)).
    A number of the current regulations were published before the early 
1990s when the NRC (and other Federal agencies) began using current 
knowledge about radiation risks and internal dosimetry. These older 
regulations generally have two or three limits associated with them. 
They tend to have separate limits for the dose to the whole body, the 
organs, and possibly, a specific limit for the thyroid (e.g., 10 CFR 
72.104 limit of 0.25 mSv/yr (25 mrem/yr) whole body, 0.75 mSv/yr (75 
mrem/yr) thyroid dose, and 0.25 mSv/yr (25 mrem/yr) to any other 
critical organ). At the time these older regulations were published, 
the Federal government was using a dosimetry system (i.e., a model that 
calculates the dose if a person ingests or inhales radioactive 
material) that did not account for the sensitivity to radiation of the 
various organs (also known as radiosensitivity) nor how the dose to an 
organ compared to a whole body dose. Because one could not add the 
various organ doses together, each needed its own limit. With little 
information on the radiosensitivity of different organs, most organs 
were given the same limit.
    In the early 1990s, the Federal government began using a newer 
dosimetry system that accounted for how radiosensitive the various 
organ systems are. In addition to being able to compare the doses 
between organs, one can calculate what whole body dose would result in 
the same cancer risk. This whole body dose is known as an effective 
dose equivalent. By summing each organ's dose, weighted by its relative 
radiosensitivity, and adding in any whole body exposure, one could 
calculate the total dose received, which is called the TEDE. Therefore, 
by using the TEDE dosimetry system, not only the whole body but each of 
the organs are protected from an increased chance of cancer. They are 
also all protected at the same level of risk, which was not true of the 
earlier system.
    Because each of the organs had the same limit under the older 
system even though each had a different level of radiosensitivity, it 
is very difficult to directly compare the old standards with the new 
standards. As noted in the proposed rule, the Commission considers 0.25 
mSv/yr (25 mrem/yr) TEDE as the appropriate dose limit to compare with 
the range of potential doses represented by the older limits that had 
whole body dose limits of 0.25 mSv/yr (25 mrem/yr). However, to conform 
to the EPA standard, the Commission has incorporated a dose limit of 
0.15 mSv/yr (15 mrem/yr) in final part 63.
    In the proposed rule, as a point of reference, it stated that the 
national average background radiation is approximately 3 mSv/yr (300 
mrem/yr). Some commenters questioned whether this was valid for the 
Nevada area considering past practices in the area. The average 
background radiation stated in the proposed rule did not include 
variations due to the geology, relative altitude above sea level, or 
past practices in the region around Yucca Mountain. The Commission does 
not consider dose from the residual radioactivity left by past 
practices to be part of the background radiation.

3.3  Calculation of Expected Dose

    Issue: Is the ``expected annual dose'' an appropriate quantitative 
measure for demonstrating compliance?
    Comment. The public noted that while a specialist may know that the 
``expected dose'' and the ``mean dose'' are equivalent, to many people 
``expected'' implies the most likely outcome. The same commenter 
asserted that the mean value derived from the performance assessment is 
not the most likely, but rather a value that is unlikely to be 
exceeded. The commenter sought clarification on whether the ``expected 
annual dose'' is the mean or the median dose or some other statistical 
measure. Some members of the public approved of the use of the mean 
dose rather than the median or mode and noted that the mean should 
provide a reasonable degree of conservatism. Furthermore, some 
commenters asserted that use of the ``expected annual dose'' is 
completely consistent with NAS recommendations that the mean value of 
the calculations be used for comparison to the standard. Finally, one 
commenter supported the use of a 25 mrem performance objective, but 
suggested that it be bolstered with the addition of a 100 mrem limit on 
the 95th percentile of the probabilistic dose distribution.
    Response. Final EPA standards at 40 CFR part 197 specify that NRC 
determine compliance based upon the mean of projected doses of DOE's 
performance assessments. The Commission has incorporated this 
requirement at Sec. 63.303 in subpart L. The mean of the projected 
annual dose is therefore the appropriate quantitative measure for 
demonstrating compliance with the dose limit. NAS recommended a 
performance objective for Yucca Mountain based on risk to an 
individual. Proposed part 63 defined ``risk'' to an individual as being 
proportional to two factors: (1) The dose to the individual from 
exposure to ionizing radiation and (2) the probability of the 
individual receiving that dose. Analyses conducted by NRC staff 
demonstrate that the mean annual dose correctly expresses the risk from 
radioactive exposure to the individual.
    The Commission expects that performance assessments conducted by 
the applicant in support of any potential license application will use 
probabilistic methods to simulate a wide range of possible future 
behaviors of the repository system. Each possible future behavior of 
the repository system is represented by a curve describing the annual 
dose to the RMEI as a function of time. Generally, but not necessarily, 
each of the possible curves is assumed to be equally likely. Because 
none of these possible futures can be demonstrated to describe the 
actual future behavior of the repository system, the Commission 
requires that the applicant calculate the mean of these dose versus 
time curves, properly weighted by their individual probabilities.
    In addition, NRC performance assessment experience indicates that 
the mean already reflects a high degree of confidence that dose limits 
will not be exceeded. For example, preliminary analysis of the proposed 
repository at Yucca Mountain (Mohanty, S., R. Codell, R. Rice, J. 
Weldy, Y. Lu, R. Byrne, T. McCartin, M. Jarzemba, and G. Wittmeyer, 
``System-Level Repository Analyses using TPA Version 3.2 Code,'' Center 
for Nuclear Waste Regulatory Analyses, CNWRA 99-002, August 1999) 
indicates that the mean exceeds the 95th percentile at early times 
(i.e., less than 600 years), the 80th percentile prior to 6,000 years 
and greater than the 70th percentile at 10,000 years. For this reason, 
NRC does not believe that addition of a 100-mrem limit on the 95th 
percentile would provide significant additional protection to the 
public.

3.4  Infant and Children Dose Standard

    Issue: Is the dose limit protective of children (and other 
sensitive populations) and the environment?
    Comment. Many commenters were concerned that the dose limits in 
part 63 may not be sufficiently protective of sensitive populations 
such as children or infants that may be more susceptible to the effects 
of radiation. Others were

[[Page 55753]]

concerned that by focusing the dose limit on protecting humans, the 
environment was not adequately protected.
    Response. The international community and the Federal agencies 
(including EPA) follow ICRP's current guidelines that the overall 
annual dose to members of the public from all sources should not exceed 
1 mSv (100 mrem), in order to be protective of all individuals and the 
environment. These guidelines also hold that exposures from a single 
practice should be limited to a fraction of this overall dose. The 
purpose of the public dose limit is to limit the lifetime risk from 
radiation to a member of the general public. The conversion factor used 
to equate dose into risk is based on data from various populations 
exposed to very high doses of radiation such as the atomic bomb 
survivors, and these populations contained individuals of all ages. 
Therefore, variation of the sensitivity to radiation with age and 
gender is built into the standards which are based on a lifetime 
exposure. A lifetime exposure includes all stages of life, from birth 
to old age. For ease of implementation, the radiation standards, which 
are developed to minimize the lifetime risk, limit the annual exposure 
that an individual may receive. For more information on the selection 
of the 0.15 mSv/yr (15 mrem/yr) limit, see the discussion under the 
Individual Dose Limit.
    Experimental studies have shown that many flora and fauna tend to 
be much more resistant to radiation than humans (Casarett, Alison, P., 
``Radiation Biology,'' Prentice-Hall, 1968, pages 220 and 300-302 and 
Nias, A.H.W., ``An Introduction to Radiobiology,'' John Wiley and Sons, 
1990, page 231). Therefore, except in cases where large concentrations 
of radionuclides can enter the environment and no reasonable exposure 
scenarios exist for humans, one of the principles of radiation 
protection is that by protecting the public, the environment is 
protected. In the case of Yucca Mountain and long-term releases, the 
primary pathway will be through the ground water. Although the 
contaminated ground water may rise up to the surface environment around 
Ash Meadows (approximately 40 km (25 miles) from Yucca Mountain), the 
contaminants will be diluted to much lower concentrations than those 
used in calculating the dose to the RMEI. Therefore, if the RMEI is 
protected from doses in excess of the dose limit, the environment is 
also protected.

3.5  Location of the Critical Group or RMEI

    Issue 1: Should the NRC staff consider alternative locations to the 
proposed 20-km location of the proposed critical group?
    Comment. Some commenters recommended that the critical group be 
located closer than 20 km (up to and including the outline of the 
repository footprint). Some commenters recommended distances greater 
than 20 km. Commenters suggested that locations downwind from Yucca 
Mountain should be considered under critical group locations. Another 
commenter suggested that NRC's limitation on well depths, based on 
1950's-1960's drilling practices, in defining a critical group, was 
outdated and needed to be revised based on modern drilling practices 
and pumping technology.
    Response. As required by law, the Commission will adopt a 
compliance location consistent with that established by EPA in its 
standards for Yucca Mountain. The EPA standards limit the permissible 
dose to the RMEI, an individual who resides in the ``accessible 
environment'', above the highest concentration of radionuclides in the 
plume of contamination. EPA has also established ground-water 
protection limits for a representative volume of water which includes 
the highest concentration level in the plume of contamination in the 
accessible environment. EPA defines the accessible environment as any 
point outside of the ``controlled area.'' As defined by EPA the 
controlled area is a 300 square-kilometer surface area that extends no 
further south than 36 deg. 40'13.6661" north latitude, or roughly 18 
kilometers, in the predominant direction of ground-water flow, and not 
beyond 5 kilometers in any other direction.
    In its 1995 findings and recommendations, NAS recommended that dose 
calculations be performed, for specific populations, to avoid unlimited 
speculation about the behavior of future human society. Specifically, 
in performing the requisite calculations, NAS recommended consideration 
of the local biosphere, using the ``critical group approach'' specified 
by the ICRP and employing ``cautious but reasonable assumptions.'' The 
ICRP has generally defined the critical group to be a relatively 
homogenous group of people whose location and habits are such that they 
are representative of those individuals expected to receive the highest 
doses as a result of radionuclide releases (International Commission on 
Radiological Protection, ``Recommendations of the ICRP,'' Annals of the 
ICRP, Vol. 1, No. 3 (1977). (ICRP Publication 26) and International 
Commission on Radiological Protection, ``Radiological Protection 
Principles for the Disposal of Solid Radioactive Waste,'' Pergamon 
Press, Oxford, 1985. (ICRP Publication 46))
    Both EPA and NRC have identified the ground-water pathway as the 
most likely pathway for radiological exposures at Yucca Mountain. EPA's 
standards, which specify the location for the RMEI at 18 kilometers in 
the predominant direction of ground-water flow, is consistent with the 
most likely pathway for radiological exposure. This location is 
generally considered the nearest location to Yucca Mountain where 
farming activities can reasonably be expected to occur. At distances 
less than 18 km to the Yucca Mountain site, there is evidence of 
intermittent or temporary occupation in modern (historic) times in and 
around the site--for prospecting or ranching (see ``Preliminary 
Performance-Based Analyses Relevant to Dose Based Performance Measures 
for a Proposed Geologic Repository at Yucca Mountain,'' T. McCartin and 
M. Lee (eds.), NUREG-1538, 2001 (in press)). There also are a number of 
Native American archeological sites reported throughout NTS closer to 
the site than the Lathrop Wells location. However, the literature 
indicates that these were never permanently occupied, and most were 
abandoned by the end of the 1800's. Overall, the literature suggests 
many reasons for the absence of permanent inhabitation at distances 
much closer than 18 km to the site--unfavorable agricultural 
conditions, inhospitable terrain, the scarcity of mineral resources, 
and limitations on water availability.
    As discussed in the proposed regulation, farming activities are 
considered to be representative of those individuals expected to 
receive the highest dose because (1) 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) and (2) the relatively large water demand 
for ground water for irrigation increases the likelihood of drawing 
contaminated water to the surface where human exposures could occur (64 
FR 8645; February 22, 1999).
    Finally, with regard to the suggestion that the NRC staff's 
understanding of drilling and pumping practices in the area is 
outdated, the Commission does not share this view. Rotary drilling 
technology, first introduced into the

[[Page 55754]]

U.S. in the early 1900's, is still used to drill most wells in the 
U.S., including those in the Amargosa Desert area. The Commission also 
is aware that there are now more efficient submersible pumps capable of 
pumping ground water from greater depths. However, the costs of 
developing deep ground-water resources increase proportionally with 
depth, regardless of pump efficiencies.
    Issue 2: Should alternatives to the proposed farming community 
critical group be considered?
    Comment. A few commenters objected to the NRC staff's proposed 
farming community critical group type and noted that parameters used by 
the NRC staff to define it were themselves controversial and 
speculative. Overall, the commenters recommended that the NRC staff 
give more consideration to the criteria used to define the 
characteristics of the critical group and, in doing so, other critical 
groups could be identified and situated at locations closer than 20 km 
to the proposed repository. A question was also raised whether doses 
would be higher if a farming critical group were located closer than 20 
km to Yucca Mountain.
    Response. EPA's standards specify the RMEI as the appropriate basis 
for application of the individual protection standard and adopted 
certain characteristics for the RMEI representative of the Town of 
Amargosa Valley. The Commission has added an additional requirement 
that DOE should assume the RMEI uses contaminated water with average 
concentrations of radionuclides in a volume of water reflective of the 
water demand associated with the community in which the RMEI resides 
(i.e., 3,000 acre-feet/yr). EPA selected a rural-residential RMEI that 
is assumed to drink two liters per day of contaminated water and 
consume some locally produced food (based on surveys) (66 FR 32092; 
June 13, 2001). As noted in the preamble to the EPA standards (66 FR 
32093; June 13, 2001), commercial farming occurs today in the 
southwestern portion of the Town of Amargosa Valley. Thus any survey of 
consumption of locally produced food for this area will include a 
variety of lifestyles including some full-time farmers, however, the 
RMEI is not assumed to be a full-time farmer. NRC proposed an average 
member of a farming community, in part, to ensure locally produced food 
was accounted for as a potential exposure pathway. The Commission 
considers the RMEI, as specified in the EPA's standards, to be 
protective and consistent with the Commission's intent of including 
locally produced food as a potential exposure pathway. Also, as noted 
in the response to the previous issue, EPA limits the location of the 
RMEI to any point outside of the ``controlled area,'' which EPA defines 
as 300 square kilometer surface area that extends no further south than 
36 deg. 40'13.6661" north latitude, or roughly 18 kilometers, in the 
predominant direction of ground-water flow, and not beyond 5 kilometers 
in any other direction. It is possible, of course, to postulate some 
other RMEI, however, doing so would be difficult to defend based on the 
pattern of historic development in the area prior to the establishment 
of NTS, and would also be inconsistent with NAS' overall 
recommendations.
    In order to avoid boundless speculation, the NAS recommended that 
the characteristics of the exposure scenario be specified by rule. 
Thus, the EPA standards specify certain characteristics of the 
biosphere and the RMEI. NRC's proposed regulation also specified many 
of these same characteristics in addition to specifying a farming 
community of approximately 100 individuals (residing on 15 to 25 
farms). This specification of the farming community provided 
flexibility to DOE in determining an appropriate water demand 
consistent with the specified farming community. It is reasonable to 
assume, based on current activities and water usage in the area, that 
the annual water demand for a farming community of this size could 
range from a few thousand to as much as ten thousand acre-feet. The 
final regulations specify a water demand of 3,000 acre-feet as a 
conservative value for use in estimating the dose to the RMEI. 
Specification of this value is consistent with: (1) The NAS 
recommendations for specifying the exposure scenario by rule; (2) NRC's 
proposed critical group (i.e., farming community of 100 individuals); 
and (3) the criteria for the RMEI specified in the EPA standards (i.e., 
diet and lifestyle representative of the people who now reside in the 
Town of Amargosa Valley, Nevada). Finally, the specification of the use 
of an average concentration is both consistent with the proposed 
regulation, which specified the use of an average dose, and the EPA 
standards that specify the use of a mean (average) dose.
    Regarding the consideration of other types of critical groups, 
examination of the literature suggests that the pattern and nature of 
development in Amargosa Valley has been influenced by two types of 
factors--natural and engineered. Foremost among the natural factors is 
the physical geography of the area--particularly the type of climate 
and the availability of water. Amargosa Valley is considered a mid-
latitude desert; it receives on average 4 inches of rain per year. 
Moreover, there are few naturally-occurring sources of drinking water 
supply; surface water supplies are restricted to a few natural springs 
and, although ground water is available, one has to drill for it. 
Because of costs associated with drilling and pumping ground water, 
agricultural development has tended to favor areas where the ground 
water is shallow. Thus, despite almost 100 years of improvements in 
farming technology, practical limitations in soil fertility combined 
with the economics of irrigation-based agriculture continue to restrict 
farming activities to the same basic location within Amargosa Valley.
    Man-made developments, such as the introduction of commercial 
electricity in Amargosa Valley in the early 1960s, have made the 
economics of irrigation-based agriculture somewhat more attractive and 
led to diversification of the local economic base which now includes a 
dairy, a turf farm, a hotel, a casino, and a golf course. The 
availability of commercial electricity has also led to a moderate 
increase in the permanent, non-farming resident population. Non-farming 
activities, as one commenter pointed out, are generally unaffected by 
ground-water depth, soil type, and other similar factors and could take 
place anywhere in the Yucca Mountain area, but have not, because the 
lands immediately surrounding Yucca Mountain are Federally-owned. It is 
likely that in addition to the existence of infrastructure (roads and 
commercial electricity) other factors as significant as the physical 
ones, also have contributed to diversification of the local economic 
base in Amargosa Valley. However, decisions to pursue diverse business 
ventures are typically made privately, by business persons or 
corporations, taking into account economic forces in the market place. 
In the Commission's view, it is impossible to predict the future 
behavior of the national or local economy and translate this behavior 
into specific human actions in the Yucca Mountain area.
    In summary, the requirement that the RMEI use water of average 
contaminant concentration, in a volume of water (3,000 acre-feet) 
reflective of a farming community, is conservative. Because the RMEI is 
defined as that person reasonably likely to receive the highest doses, 
the selection of RMEI characteristics must take into consideration both 
the magnitude of the dose likely to be received and the likelihood that 
a dose will actually occur at that location. The Commission believes 
that EPA selected the characteristics of the RMEI based on

[[Page 55755]]

cautious and reasonable assumptions for the community of individuals 
likely to receive the highest doses. For these reasons, the Commission 
has adopted EPA's definition of the RMEI, as it appears at 40 CFR part 
197 and added the additional requirement for water usage by the RMEI.
    Issue 3: How will potential doses from the air-pathway be evaluated 
during the period of repository operations (preclosure period)?
    Comment. A subject of continuing concern for any possible geologic 
repository at Yucca Mountain is the potential effects of unexpected 
(low probability) releases of gaseous/particulate radionuclides during 
the preclosure phase of operations (i.e., DBEs). As a matter of 
background, it was noted that radioactive fallout from atmospheric 
tests of nuclear weapons conducted at the NTS during the 1950's was 
transported by prevailing westerly winds to communities east of the 
NTS, such as Caliente (Nevada). Because prevailing wind patterns are 
unlikely to change, concerns were expressed that health effects similar 
to those assumed to have resulted from atmospheric testing may arise 
from potential repository operations. Accordingly, it was suggested 
that a critical group based on exposure to an air-pathway should be 
evaluated.
    Response. The Commission is aware of the effects of local 
atmospheric conditions on past nuclear testing activities (which were 
not subject to NRC regulation). During operations, DOE is required to 
control releases from all potential pathways, including atmospheric, 
such that no member of the public is exposed to more than 0.15 mSv/year 
(15 mrem/year). To comply with this requirement (at Sec. 63.111) DOE 
will need to account for potential gaseous and particulate releases to 
existing members of the public (including current down-wind 
communities, such as Caliente). This requirement also directs DOE to 
conduct a preclosure safety assessment (Sec. 63.112) that shows (1) 
that the GROA design and normal operations at the site will limit the 
release of gaseous and particulate radionuclides so that the public 
dose will remain below 0.15 mSv/yr (15 mrem/yr) dose and (2) that in 
the event of an unlikely, but credible emergency situation, the design 
is robust enough to constrain potential doses to within acceptable 
public health and safety standards.

3.6  Critical Group Characteristics and Reference Biosphere

    Issue 1: Is the average member (of a critical group) an appropriate 
measure to protect public health and safety?
    Comment. A number of commenters focused on the proposed approach of 
calculating doses to an average member of a critical group. Commenters 
noted: (1) Use of the average member results in some people (aside from 
those with extreme habits) receiving less protection than others (i.e., 
individuals protected by assuming current conditions may not be 
protected under potentially different future conditions); (2) the 
proposed rule does not provide a definition of the average member of 
the critical group; (3) the appropriate measure is the average of 
calculated doses to members of the critical group rather than a single 
dose calculated for a single member with average characteristics; and 
(4) a subset of the farming group that would be more likely to 
experience health effects (e.g., children) should be used.
    A few commenters suggested use of a subsistence farmer. One 
commenter added that sensitivity studies should be done for a 
subsistence farmer (i.e., all food locally grown) located closer than 
20 km from the proposed repository site to gain insights into risk, 
even though such a scenario would be unlikely.
    Response. Although the Commission finds that limiting the dose 
received by the average member of the critical group is protective of 
current and future populations in the vicinity of the site, the final 
rule has been changed, as required by EnPA, to use 40 CFR part 197's 
mean dose to the RMEI as the measure to compare with the dose limit. 
The RMEI approach has been characterized as providing a similar level 
of protection to that achieved by protecting the average member of the 
critical group, as was proposed for part 63. In its comments to EPA on 
the proposed 40 CFR part 197, the NAS noted that the reasonably 
maximally exposed individual is very similar to the internationally 
used critical group approach. Additionally, in the proposed rule, NRC 
quoted the International Commission on Radiological Protection, which 
stated that it may be convenient to define the critical group in terms 
of a single hypothetical individual. The International Atomic Energy 
Agency's (IAEA's) Biosphere Modeling and Assessment working group has 
taken it further and calls such a hypothetical individual a reasonably 
maximally exposed individual (BIOMASS, 1999). Although there are slight 
differences between the EPA's reasonably maximally exposed individual 
and NRC's proposed average member of the critical group, they are 
virtually the same (especially in view of the IAEA's guidance). As 
noted earlier, the Commission has adopted the RMEI approach to be 
consistent with 40 CFR part 197.
    The issue of whether children are protected has been taken into 
consideration in developing the rule (see discussion under Infant and 
Children Dose Standard). In summary, the standards were developed with 
sufficient conservatism to protect all members of the public regardless 
of age or gender.
    The Commission disagrees with the recommendation that the NRC 
should use the admittedly unlikely subsistence farmer approach as the 
basis to test sensitivities (for additional information on the 
subsistence farmer approach, see the response to Issue 2, below). The 
NRC expects that sensitivity studies based on unrealistic and unlikely 
exposure scenarios would provide results that would be difficult to 
interpret and relate to the actual anticipated conditions of exposure. 
The NRC, however, agrees with the commenters' recognition of the value 
of sensitivity analysis as a tool to gain insight into uncertainties 
and the importance of parameters and models. NRC conducted extensive 
sensitivity analyses with an independently developed total performance 
assessment code (Nuclear Regulatory Commission, ``Sensitivity and 
Uncertainty Analysis for a Proposed Repository at Yucca Mountain, 
Nevada, Using TPA 3.1, Volume 2: Results and Conclusions,'' NUREG 1668, 
Vol. 2, Washington DC: Nuclear Regulatory Commission) in the 
development of the proposed rule.
    Issue 2: Has NRC made cautious and reasonable assumptions about the 
characteristics of the proposed critical group?
    Comment. A variety of comments were received which are related to 
critical group assumptions specified in the proposed NRC rulemaking. A 
few commenters disagreed with specification of critical group 
characteristics based on current conditions, noting that over long time 
frames such conditions are likely to change. Another commenter asserted 
that the assumption that all locally grown food is contaminated is 
vague because the proposed rule does not state all food consumed by the 
critical group is locally grown (the commenter disagreed with the use 
of a subsistence farmer approach that would result from assuming all 
consumption was local). The commenter further stated that the expected 
plume dimensions and

[[Page 55756]]

number of farms make the assumption that all local food is contaminated 
excessively conservative (i.e., tends to overestimate dose). The 
commenter noted local surveys show that not all food consumed in 
Amargosa Valley is locally grown. Other commenters offered that the 
critical group should be a subsistence farmer because that approach is 
conservative and bounding (suggesting that no dose would be allowed 
higher than the critical group's and therefore it would be protective 
of all). Another commenter stated the reasonably maximally exposed 
individual for a subsistence farmer also provides broad protection of 
all people (excepting those with extreme habits), and its conservatism 
would lessen the effect of assuming constancy of future behaviors. 
Still another commenter tentatively approved the NRC choice for 
critical group noting the actual critical group is likely to involve 
commercial, light industrial activities and, therefore, assuming a 
farming community is conservative (i.e., protective). One commenter 
questioned the accuracy of the reported population count for Amargosa 
Valley.
    Some commenters suggested alternative critical groups as being more 
representative or protective of the local population. Representatives 
of the Western Shoshone people suggested their long existence in the 
region and lifestyle in close proximity to the land support selection 
of a Western Shoshone critical group. They noted a long history of a 
hunting and gathering ``subsistence'' lifestyle that is expected to 
remain into the future. Farming and livestock activities were also 
discussed as recent introductions to the Western Shoshone lifestyle.
    Response. Although the Commission considers the proposed 
assumptions about the characteristics of the critical group to be 
protective of current and future populations in the vicinity of the 
site, the final rule has been changed, as required by EnPA, to use the 
mean dose to the RMEI, as defined at 40 CFR part 197, as the measure to 
compare with the dose limit. Although there are slight differences 
between the characteristics of EPA's reasonably maximally exposed 
individual and the proposed average member of the critical group, they 
are practically the same. However, as noted, the Commission has adopted 
the characteristics of the RMEI as specified in 40 CFR 197 and added 
two additional requirements.
    Regarding the two additional requirements, the final regulations 
specify: (1) The water demand to be used in estimating exposure to the 
RMEI (see response to Issue 2 under Critical Group Location); and (2) 
that the RMEI is an adult with metabolic and physiological 
considerations consistent with present knowledge. Specification of the 
RMEI as an adult is: (1) Consistent with the NAS recommendations for 
specifying the exposure scenario by rule; (2) consistent with the 
proposed regulation characteristics for the exposure scenario; (3) 
consistent with the criteria for the RMEI specified in the EPA 
standards (i.e., drinks 2 liters of water per day); and (4) consistent 
with the EPA's Draft Federal Radiation Protection Guidance for 
Exposures of the General Public (59 FR 66422; December 23, 1994). The 
Commission considers the RMEI approach and associated characteristics 
of the RMEI to be protective of the health and safety of the public and 
environment (see also responses under Infant and Children Dose Standard 
and Location of the Critical Group or RMEI).
    The Commission disagrees with the suggestions that a subsistence 
farming critical group should be used in dose calculations or that the 
RMEI be a subsistence farmer. As noted above, the Commission considers 
the RMEI approach from 40 CFR part 197 to be fully protective. The RMEI 
approach requires DOE to use diets and lifestyles representative of the 
people who now reside in the Town of Amargosa Valley, Nevada. 
Therefore, a variety of diets and lifestyles, including farming as it 
occurs today, will be represented in the characteristics of the RMEI. 
The Commission considers the use of local, present day conditions to be 
the most realistic basis for RMEI behavior assumptions, and present 
evidence indicates that there are no subsistence farmers in the 
vicinity of Yucca Mountain. NRC disagrees with the suggestion that the 
excessive conservatism of the subsistence approach is needed to offset 
any presumed lack of conservatism from the assumption of current 
conditions.
    The Commission also disagrees with the suggestion that a Shoshone 
critical group should be used in dose calculations or that the RMEI be 
a Western Shoshone. In defining the critical group for the proposed 
rule, the Commission considered the possibility of a Native American 
based critical group. To date, based on all the information including 
the information provided by public comments, NRC has not been able to 
identify a suite of common characteristics of Native American groups in 
the region that is both different from the proposed farming critical 
group and likely to lead to greater exposures than the proposed farming 
critical group or the RMEI. Thus, the NRC believes the use of a RMEI 
for postclosure exposures protects Native Americans as well as other 
members of the public.
    Issue 3: Should NRC include potential future climate changes in the 
specification of a reference biosphere?
    Comment. One commenter asked that the NRC clarify whether it has 
determined with certainty that a future ice age will occur and, if so, 
provide the supporting documentation. If such a determination has not 
been made, NRC should revise the proposed rule to reflect greater 
uncertainty with regard to climate change. DOE recommended that NRC 
move proposed Sec. 63.115(a)(3) and (4) to proposed Sec. 63.114 to 
remove the implication that climate change needs to be considered for 
biosphere assumptions. Both DOE and another commenter claimed that 
because NRC expects that climate change (from arid to semi-arid) will 
not alter the biosphere sufficiently to cause major changes in 
potential exposure pathways, climate change should be removed from the 
biosphere requirements. DOE noted that climate change and changes in 
the geologic setting affect the performance assessment and, thus, 
should be moved to Sec. 63.114. Another commenter recommended deleting 
proposed Sec. 63.115(a)(3) and revising proposed Sec. 63.115(a)(2) to 
reflect current climate conditions. Yet another commenter stated that 
evolution of the geologic setting should not be part of the reference 
biosphere, and thus the requirements should be moved under performance 
assessment (proposed Sec. 63.114).
    A commenter stressed the need to emphasize present-day conditions 
for defining the biosphere and provided a number of supporting points 
for NRC consideration. The commenter agreed with NRC that use of future 
human behavior is speculative and, thus, it is appropriate to limit 
assumptions to present-day behavior. The commenter noted risks to 
future generations should be based on levels deemed tolerable by 
present day society. The commenter claimed such analyses of future risk 
can only be done by assuming present-day behavior. The commenter also 
noted that using present-day characteristics provides confidence to the 
local community.
    Another commenter believed that the emphasis on present-day 
conditions, while adequate for the time of site characterization, does 
not take into consideration processes and events currently taking place 
in Southern Nevada which could lead to different futures. Cited 
examples include the rapid growth that has occurred (and

[[Page 55757]]

continues) in Southern Nevada over the past 30 years and the increase 
in urban growth of southern Nye County (e.g., Pahrump). Such growth was 
noted as important because it increases demand for, and pumping rates 
of, ground water, which could lead to changes in gradients that would 
accelerate contamination. It was further mentioned that ground-water 
sources north of Clark county have long been considered options to meet 
future water demands. For these reasons, the NRC should consider such 
future possibilities as alternatives to present-day biosphere 
conditions.
    Response. Because some commenters questioned the Commission's basis 
for including climate change in the performance assessment requirements 
of the proposed rule, the Commission responds by providing additional 
information supporting the theory that climate change is possible 
during the proposed period of performance. The inclusion of climate 
change in biosphere requirements is consistent with the EPA standards 
and is also further justified based on a reasonable likelihood that 
climate change will occur in the future and the fact that such changes 
have the potential to impact the biosphere. However, comments 
suggesting that NRC consider future economic growth trends ignore 
inherently large uncertainties in predictions of such futures over both 
short and long time frames. The Commission finds that the inclusion of 
such future predictions would add inappropriate speculation into the 
requirements, would not enhance public safety, and is likely 
inconsistent with the EPA standards. Therefore, the language of the 
proposed rule, which requires DOE to consider climate change and 
precludes consideration of changes to assumptions of lifestyle and land 
use, that could be subject to speculation about future economic growth, 
is retained in the final rule, with the exception that the critical 
group has been replaced with the RMEI for consistency with EPA's 
standards.
    Although it is beyond the capabilities of present-day science to 
determine ``with certainty'' that a future ice age will occur, the 
present paleoclimatic data support that (1) ice ages have occurred in 
past history, (2) climate changes in the past have exhibited a cyclical 
pattern, and (3) the cycle is likely to lead back to another ice age. 
The NRC has extensively investigated relevant research on future 
climate change in the vicinity of Yucca Mountain and has summarized the 
available information in an Issue Resolution Status Report (Nuclear 
Regulatory Commission, ``Issue Resolution Status Report Key Technical 
Issue: Unsaturated and Saturated Flow Under Isothermal Conditions,'' 
Revision 2, Vol 1, Washington DC: Nuclear Regulatory Commission, June 
1999). (For more information about obtaining reports from the NRC PDR, 
mail a request to U.S. Nuclear Regulatory Commission, Public Document 
Room, Mail Stop O1F13, Washington DC 20555, or e-mail [email protected].) The 
NAS committee also was familiar with the science behind future climate 
changes and stated, in its recommendations on Yucca Mountain standards, 
that a future ice age in the next few hundred years is unlikely but not 
impossible, in the next 10,000 years is probable but not assured; 
however, over a million-year time frame, the climate is virtually 
certain to pass through several glacial-interglacial cycles (i.e., ice 
ages). The Commission believes there is sufficient information in the 
paleoclimate record to justify including climate change in the final 
regulations regarding effects on repository performance.
    Climate change was included in the proposed regulations for the 
reference biosphere in Sec. 63.115 because the NRC believed there was 
sufficient scientific evidence supporting the potential for climate 
change over the long time frames considered by the performance 
assessment calculations. Although NRC analyses suggest that inclusion 
of climate change in the biosphere is not likely to significantly 
change the assumed local climate conditions and assumed exposure 
conditions, the Commission believes it is important to include the 
consideration of climate change in both the geosphere and the biosphere 
performance assessment calculations to ensure that the conceptual model 
of the environment is consistent with our scientific understanding of 
reasonably anticipated natural events. The NRC also believes it is 
important for DOE to include these processes in its performance 
assessment calculations and do the necessary technical analyses to 
ensure the processes have been adequately considered and addressed.
    The NRC agrees there is a need to emphasize current conditions when 
applied to behavioral characteristics of the RMEI. The natural systems 
of the biosphere are allowed to vary (e.g., climate change) because the 
geologic record provides evidence of past climate over a long time 
frame, which provides a strong basis for predicting future changes. 
Because human behavior cannot be similarly predicted, a similar 
approach cannot be used for the RMEI and the influence the local 
population has on the biosphere. Thus, it is necessary to emphasize 
current conditions for the RMEI (see response to Issue 1 for more 
information). The suggestion that NRC consider alternative futures 
related to human behavior is speculative and leads to problems deciding 
which alternative futures are credible and which are unrealistic. Such 
questions have no scientific or technical answer. It is DOE's 
responsibility to demonstrate that the RMEI and biosphere assumptions 
in performance assessment calculations are consistent with local 
conditions. During the review of the license application, the NRC will 
evaluate DOE's assumptions to ensure they are consistent with current 
information. Given the uncertainties associated with local economics, 
NRC believes it is unreasonable to expect DOE to predict future growth 
conditions in local areas and the consequences of growth trends.

3.7  Absence of Separate Ground-Water Protection Criteria

    Issue: Why are there no separate requirements for the protection of 
ground water given the importance of ground water in the arid 
environment of Yucca Mountain and the fact that the most likely pathway 
for radionuclides to escape from the repository is via the ground-water 
pathway?
    Comment. Commenters were divided on whether separate requirements 
for protection of ground water are necessary. Commenters supporting 
separate requirements for protection of ground water provided various 
rationales for instituting separate requirements, such as: (1) Ground 
water represents a valuable resource deserving separate protection; (2) 
ground water is the most likely source of contamination to Yucca 
Mountain residents; and (3) ground water at Yucca Mountain should be 
provided the same level of protection afforded other sites around the 
country that are subject to separate ground-water protection 
requirements under the Safe Drinking Water Act (SDWA). Generally, these 
commenters recommended protecting ground water by either limiting 
individual exposure from drinking water to 4 mrem per year or using 
EPA's maximum contaminant levels (MCLs). However, some commenters 
opposed the imposition of separate requirements for protecting ground 
water. One commenter opposed to separate requirements for protection of 
ground water stated: (1) An overall system approach for safety is 
appropriate, and separate requirements for protection of ground water 
represent unnecessary subsystem requirements and (2) such requirements 
would not be consistent with the recommendations of

[[Page 55758]]

NAS and go beyond the health-based standards mandated in section 801 of 
the EnPA.
    Response. The Commission has commented previously that an 
individual, all-pathway dose limit of either 0.15 mSv (15 mrem) or 0.25 
mSv (25 mrem) TEDE ensures that the risks from all radionuclides and 
all exposure pathways, including the ground-water pathway, are 
acceptable and protective. The EPA itself acknowledged, in publishing 
final standards for Yucca Mountain, that an `` * * * Individual 
Protection Standard is adequate in itself to protect public health and 
safety.'' However, ultimately, the EPA had to make the decision whether 
to include separate requirements for groundwater protection and the 
final EPA standards for Yucca Mountain include such requirements for 
the purpose of protecting groundwater. Therefore, as required by law, 
final part 63 requirements incorporate final EPA standards for Yucca 
Mountain at 40 CFR part 197, including separate ground-water protection 
requirements. These requirements, Secs. 197.30 and 197.31, appear in 
the final 10 CFR part 63 regulations as Secs. 63.331 and 63.332, 
respectively.

3.8  Multiple Barriers and Defense in Depth

    Issue 1: Should NRC set quantitative limits (that is, subsystem 
requirements) for specific barriers that make up the repository system?
    Comments. The NRC received comments both supporting and opposing 
the approach proposed in part 63, which would provide a single overall, 
health-based, performance objective and avoid setting arbitrary, 
quantitative limits on individual barriers. Commenters in favor of a 
single system performance goal stated that risk-informed and 
performance-based regulations allow the applicant and the regulator to 
place greatest emphasis on issues important to health and safety. 
Commenters supporting quantitative limits for specific subsystems 
expressed concern that reliance on quantitative performance assessments 
to show compliance with a single measure of performance is less 
protective than setting specific numerical criteria for the performance 
of individual barriers. They argued that quantitative limits for 
individual barriers are needed to provide greater assurance for overall 
repository performance and, in general, supported keeping the 
quantitative limits at part 60.
    Response. The Commission believes that it presented a sound basis 
for the proposed approach to multiple barriers and defense in depth in 
the Supplementary Information accompanying the proposed part 63. The 
final rule adopts a single quantitative performance goal for individual 
protection and separate limits for ground-water protection as specified 
by the EPA standards. Beyond these, the final rule does not place 
quantitative limits on individual barriers. After considering the 
comments received, however, the Commission recognizes a need to clarify 
the multiple barrier requirements in the proposed rule. The response to 
the next issue discusses the specific clarifications adopted.
    The Commission based its proposed treatment of multiple barriers on 
the following:
    1. Consistent with the Commission's risk-informed and performance-
based regulatory philosophy, DOE is provided flexibility for deciding 
the extent and focus of site characterization. As the repository 
designer, DOE may place greater or lesser reliance on individual 
components of the repository system when deciding how best to achieve 
the overall safety objective.
    2. Estimates of subsystem performance are subject to many, if not 
all, of the same sources of uncertainty as are estimates of overall 
system performance. It is questionable, therefore, whether the 
subsystem criteria in part 60, or any other criteria, could provide 
truly independent assurance of total system performance.
    3. The Commission recognizes that techniques of performance 
assessment have improved a great deal because of significant advances 
in knowledge and experience achieved since part 60 was developed. These 
advances in performance assessment technology support the use of 
performance assessment results for estimating long-term repository 
performance. They also obviate, in the Commission's view, the need to 
prescribe arbitrary, minimum performance standards for subsystems to 
build confidence in a system's overall performance.
    The Commission's goal is to protect public health and safety and to 
ensure compliance with EPA's standards. NRC's evaluation of DOE's 
compliance demonstration will examine how all components of the 
repository system work together to achieve this goal. Therefore, the 
emphasis should not be on the isolated performance of individual 
barriers but rather on ensuring the repository system is robust, and is 
not wholly dependent on a single barrier. Further, the Commission 
supports an approach that would allow DOE to use its available 
resources effectively to achieve the safest repository without 
unnecessary constraints imposed by separate, additional subsystem 
performance requirements. It is also important to remember that part 63 
requires DOE to carry out a performance confirmation program to provide 
further confidence that barriers important to waste isolation will 
continue to perform as expected (see Section 2.4 on Performance 
Confirmation).
    Issue 2: How does the multiple barrier provision fulfill NRC's 
philosophy of defense in depth in evaluating repository performance?
    Comments. Some commenters asked the NRC to explain how we apply 
defense in depth to the repository without specific calculations or 
numerical limits for meeting this requirement. They stated that the 
proposed part 63 is not clear about how DOE must demonstrate defense in 
depth for repository performance.
    Response. In general, the Commission believes that a repository 
system should reflect the philosophy of defense in depth. The 
Commission expects that if a repository system is made up of multiple 
barriers, then it will be more tolerant of unanticipated failures and 
external challenges. The final regulations specify criteria for 
quantitatively evaluating postclosure performance (e.g., individual 
protection, ground-water protection, and evaluation of human 
intrusion). These criteria help ensure defense in depth by requiring 
calculations that provide risk insights into the impact on performance 
of specific system attributes and external conditions. DOE must 
evaluate the performance of the repository system, as it performs as a 
result of compliance with general design criteria (e.g., required use 
of multiple barriers and identification of the repository by markers). 
DOE must also evaluate the system's response to various external 
challenges (e.g., disruptive events treated in the performance 
assessment, as well as a specified human intrusion scenario).
    Commenters on the proposed rule pointed out that neither the intent 
of the multiple barrier provision, mandated by the Nuclear Waste Policy 
Act, nor how NRC would determine compliance with this provision, were 
clear. To clarify this intent, the final rule explains the concepts 
associated with the multiple barrier provision in Sec. 63.102, and 
provides the criteria in Sec. 63.115.
    The proposed rule would have required and the final rule requires 
DOE to: (1) Identify barriers; (2) describe quantitatively each 
barrier's ability to contribute to waste isolation; and (3)

[[Page 55759]]

provide technical bases for the barriers' capabilities as part of the 
overall demonstration of compliance with the individual protection 
standard (see Sec. 63.114 (h)-(j) of the proposed rule). Although not 
necessarily required as a separate demonstration, this required 
information on the capability of barriers, integral to the performance 
assessment, illustrates the resilience or lack of resilience of the 
repository to unanticipated failures or external challenges. Also, 
quantitative insights about the defense in depth of the proposed 
repository emerge directly from the quantitative evaluations in the 
performance assessment. The performance assessment must include 
analyses of the effects of unlikely, but credible, external challenges 
on overall performance. (In its analyses, DOE must consider disruptive 
events that have an annual probability of occurrence greater than 
10-8.) Disruptive events may degrade performance of the 
engineered barriers or reduce the effectiveness of natural barriers or 
both. Also, DOE must evaluate uncertainty about the performance of both 
engineered and natural barriers in the performance assessment. For 
example, uncertainty about the corrosion rate of the waste package will 
necessarily affect the estimated lifetime of the package. Likewise, 
uncertainty about geochemical sorption will affect estimates of the 
time it takes specific radionuclides to travel in the geosphere. As 
with the disruptive events, the proper consideration of uncertainty in 
the performance assessment should ensure an evaluation of the range of 
response of individual barriers to various challenges (e.g., higher 
than normal corrosion rates, lower than normal geochemical sorption). 
Thus, a complete performance assessment (i.e., one that complies with 
Sec. 63.114) will illustrate the effectiveness of the multiple 
barriers, and the implementation of the philosophy of defense in depth, 
such that the individual protection standard is shown to be met even 
when barriers are challenged.
    The Commission has clarified how DOE is to develop the technical 
basis for each barrier's technical capability. The change makes clear 
that a description of relevant information about a given barrier's 
characteristics and performance, which DOE has used to support the 
overall performance assessment, is sufficient to show compliance with 
this requirement. The language of the proposed rule was not intended to 
imply that an acceptable technical basis for multiple barriers need be 
(or even could be) derived separately from the basis for the 
performance assessment itself. Rather, the technical basis for the 
barriers should be presented in a focused, clear description. This 
description should be derived from pertinent information contained in 
the technical basis for the performance assessment.
Quantitative or Qualitative Assessment?
    Consistent with the proposed rule, the final rule allows DOE to 
select from various methods to describe the capabilities of the 
barriers. Regardless of the method selected, DOE must describe the 
capability of each barrier to perform its intended function and the 
relationship of that barrier's role to limiting radiological exposure 
in the context of the overall performance assessment. The Commission 
has considered the comment that an evaluation of each barrier's 
capability should be quantitative. The Commission continues to believe 
a qualitative approach, as proposed, is appropriate for the following 
reasons:
    1. It provides the Commission with information to be considered in 
its decisions without constraining its considerations to a specific 
limit for a particular barrier, which could result in less favorable 
overall system performance.
    2. It gives the Commission the flexibility to consider the nature 
and extent of conservatism in the evaluations used for compliance 
demonstration, and to decide whether there is a need to require DOE to 
reduce uncertainties in its assessment (e.g., collecting more site 
data) or to include further mitigative measures.
    3. Quantitative evidence of the capability of individual barriers 
to contribute to waste isolation is an integral part of the performance 
assessment. Therefore, an additional quantitative limit is not 
necessary to show that overall performance reflects a system of 
multiple barriers.
    The Commission understands that establishment of explicit, 
quantitative limits for individual barriers might be considered a 
desirable and more easily explained approach. That being said, however, 
the Commission knows of no scientific basis for setting such limits for 
particular barriers at Yucca Mountain, or at any other site, 
independent of the complex repository system in which they must 
perform. The Commission is confident that evidence for the resilience, 
or lack of resilience, of a multiple-barrier system will be found by 
examining a comprehensive and properly documented performance 
assessment of the behavior of the overall repository system. Such an 
assessment must consider credible and supportable ranges of individual 
parameters and modeling assumptions, and must include multiple 
evaluations of a wide range of combinations of resulting barrier 
performance.
    Finally, the required description of barrier capability provides 
information that will aid in the interpretation of the performance 
assessment results, while at the same time providing information that 
is independent from the condition of the other barriers. For example, 
the unsaturated and saturated zones could provide significant 
retardation to many radionuclides such that radionuclides will not 
reach the RMEI within 10,000 years regardless of when the waste package 
fails. This capability of geologic systems to ``retard'' or slow the 
movement of contaminants exists whether or not the waste package is 
breached. Thus a geologic barrier can provide defense in depth 
irrespective of releases from the waste package. Describing the 
capabilities of the system's component barriers (e.g., retardation of 
specific radionuclides in specific geologic media) can be accomplished 
by describing the applicable conceptual models and parameters used in 
the performance assessment. It does not require quantitative 
calculations beyond those performed to demonstrate compliance with the 
postclosure performance objectives. The Commission believes that 
understanding the capability of the system's component barriers 
provides an understanding of the repository system that can increase 
confidence that the postclosure performance objectives are met. The 
Commission is satisfied that the clarifying additions discussed above, 
along with other requirements at Secs. 63.114 and 63.115, if met, will 
provide sufficient basis to determine whether a proposed repository 
system acceptably provides a system of multiple barriers.

3.9  Compliance Period

    Issue 1: Is a 10,000-year compliance period reasonable in light of 
the NAS recommendations?
    Comment. Several commenters stated that a 10,000-year compliance 
period conflicts with the NAS recommendation 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 
system, and that rejecting the NAS recommendation is arbitrary.
    Response. The EPA standards for Yucca Mountain provide for a 
demonstration of compliance over a 10,000-year time frame. Moreover, 
the

[[Page 55760]]

Commission agrees that a 10,000-year compliance period is reasonable 
for the reasons identified in the supplementary information provided 
with the proposed criteria at part 63 (64 FR 8647; February 22, 1999). 
The fact that it is feasible to calculate performance of the engineered 
and geologic barriers making up the repository system for periods much 
longer than 10,000 years does not mean that it is possible to make 
realistic or meaningful projections of human exposure and risk, 
attributable to releases from the repository, over comparable time 
frames. NAS acknowledged that projecting the behavior of human society 
over long periods is beyond the limits of scientific analysis and 
recommended that ``cautious, but reasonable'' assumptions, based upon 
current knowledge, be made with regard to the selection of biosphere 
and critical group parameters for Yucca Mountain. Determining just how 
far into the future current knowledge can no longer support 
``reasonable'' assumptions about pathways affecting human exposure is 
clearly a subjective, policy judgment. NRC believes that, for periods 
approaching 1,000,000 years, as suggested by NAS, during which 
significant climatic and even human evolution would almost certainly 
occur, it is all but impossible to make useful and informed assumptions 
about human behaviors and exposure pathways. NAS explicitly 
acknowledged that selection of a time period over which compliance 
should be evaluated necessarily involves both technical and policy 
considerations (see p. 56, ``Technical Bases for Yucca Mountain 
Standard,'' National Research Council, 1995).
    Issue 2: Should NRC require DOE to provide supplemental analyses of 
repository performance at times other than 10,000 years?
    Comment. One commenter stated that although a 10,000-year 
compliance period is well justified, it would be beneficial to require, 
either by rule or guidance, a supplemental analysis for performance at 
1,000 years. This analysis would help to identify vulnerabilities such 
as juvenile failures of waste packages, so that DOE can reduce the 
likelihood and consequences of such vulnerabilities. The same commenter 
also stated that a supplemental analysis at 100,000 years, or even 
later, can provide a useful projection of the final transport of waste 
from the repository, particularly for the very long-lived isotopes.
    Response. The Commission will not require DOE to provide 
supplemental analyses of repository performance at times other than 
10,000 years. To demonstrate compliance with the individual dose limit, 
the expected annual dose needs to be below the regulatory limit at all 
times within the 10,000-year compliance period. This requires a time 
history of repository performance throughout the 10,000-year compliance 
period. Therefore, repository performance at 1,000 years can be derived 
from the performance assessment provided by DOE in the license 
application. A separate, supplemental analysis at 1,000 years is not 
necessary. It may be useful to note that NRC pre-licensing activities 
include providing guidance that DOE (and other stakeholders) can use to 
develop a transparent performance assessment that will reveal an 
understanding of the relationship between the performance of individual 
components or subsystems of the geologic repository and the performance 
of the total system at all times over the 10,000-year compliance 
period.
    In response to Issue 1 (Is a 10,000-year compliance period 
reasonable in light of NAS recommendations?), the Commission questions 
the realism and meaningfulness of projections of human exposure and 
risk, attributable to releases from the repository, over time frames 
much longer than 10,000 years. Requiring DOE to provide a separate 
analysis of repository performance over very long times in the license 
application would be inconsistent with our position on the utility of 
this information, as well as with EPA's standards for Yucca Mountain. 
The EPA standards require that DOE include an analysis of repository 
performance up through peak dose in the EIS which would accompany any 
potential license application. This provision is included in the final 
part 63 regulations at Sec. 63.341. The Commission notes that there is 
no standard that must be met with respect to these peak dose 
calculations, and that there is no finding that the NRC must make with 
respect to these peak dose calculations nor may they be the subject of 
litigation in any NRC licensing proceedings for a repository at Yucca 
Mountain.

3.10  Human Intrusion Scenario

    Issue 1: Is the Commission's proposal for the human intrusion 
calculation appropriate for evaluating the ability of the repository to 
withstand an intrusion event?
    Comment. Some commenters noted that, because of the uniqueness of 
the repository, it is likely that institutions involved with the 
development, construction, and operation of a repository, and knowledge 
of its existence, are likely to persist longer than 100 years after the 
repository is permanently closed. Because some form of institutional, 
corporate, or anecdotal knowledge about the proposed repository, would 
exist well beyond closure, any drilling into the repository would be 
advertent, not inadvertent, contrary to the NAS'' recommendation. Thus, 
given the likelihood of multi-generational knowledge about any proposed 
repository that could persist well beyond permanent closure, there is 
no reason to believe that unintended human intrusion would occur 
shortly after the loss of institutional controls. Also, given the 
current waste package design, DOE asserted that current drilling 
techniques would likely not lead to waste package penetration without 
recognition by the drillers. Other commenters noted that any natural 
resource exploration campaign is likely to involve more than an 
exploratory borehole. Moreover, because of the potential for changing 
resource needs over the long period of regulatory concern, there is the 
possibility for multiple exploration campaigns and, thus, the potential 
for multiple boreholes breaching the repository. Consequently, the rule 
should be changed to require that effects of multiple boreholes on 
repository performance be evaluated.
    One commenter questioned the rationale for not regulating the 
radioactive materials brought to the surface, in drill cuttings or 
captured in drill core, because these materials would enter the 
biosphere and have the potential for exposing members of the drilling 
crew and the public.
    Response. The Commission supports and is implementing the approach 
for evaluation of human intrusion as specified in EPA's final 
standards. The Commission proposed at part 63 a stylized calculation 
that prescribed the timing of the intrusion (i.e., 100 years after 
permanent closure), the repository barriers affected by the intrusion 
(i.e., unsaturated zone and the waste package), and the relevant 
exposure pathway (i.e., ground-water pathway). The comments received 
reflect the difficulties presented to EPA and to the Commission in 
selecting an appropriate approach for evaluating human intrusion. As 
noted by NAS, selecting an approach for evaluating human intrusion 
requires consideration of unknowns (i.e., how and when intrusion into 
the repository will occur), ability to estimate the effect of a 
postulated intrusion into the repository, and policy considerations for 
setting an appropriate standard. In the proposed rule, the Commission 
specified a ``stylized'' calculation to test resilience of the 
repository and preclude

[[Page 55761]]

speculation on the form of the intrusion and when it may occur. 
However, the Commission also believes it is necessary to provide 
flexibility to DOE to support an alternative calculation such as the 
approach provided in EPA's final standards. The final EPA standards 
provide DOE the flexibility to identify the time of the intrusion as 
the earliest time that human intrusion into the waste package could 
occur without recognition by the drillers. The Commission has 
implemented this approach in the final regulations.
    Responses to specific comments on the timing and frequency of the 
intrusion, details of the intrusion scenario regarding effects on the 
contents of the waste package, and exposure pathways for the intrusion 
are provided below:
Timing and Frequency of Intrusion
    DOE commented that the proposed calculation was unrealistic because 
it is unlikely that a borehole would intersect a waste package because 
the cross-sectional area of the waste packages is small relative to the 
overall area of the repository footprint. DOE also noted that, at 100 
years, it is unlikely the waste package could be penetrated, using 
current drilling techniques, without recognition by the drillers (DOE 
does not expect the waste packages to degrade significantly during the 
10,000-year regulatory period). The final regulation, which implements 
the approach contained in the EPA standard, provides DOE with the 
flexibility to determine and to justify (subject to NRC review) its 
selection of the time of the intrusion event based on the condition of 
the waste package.
    Another related issue is whether the stylized calculation should 
consider multiple intrusions. The final EPA standards resolve this 
issue in favor of a single intrusion. Moreover, in its findings and 
recommendations, NAS argued against analyses of whether and how often 
exploratory drilling would occur at Yucca Mountain because of the 
complexities associated in such assessments. Simply stated, the NAS 
felt that no one can accurately predict the characteristics of future 
human society and their technology. In the context of human intrusion, 
estimating the probability of exploratory drilling for a given resource 
relies on an ability to predict certain economic and technical factors 
that influence supply of, and demand for, that resource. In fact, NAS 
noted that the continued advances in noninvasive geophysical techniques 
may, in fact, reduce the number and frequency of exploratory boreholes. 
However, some evaluations of the resource potential of the site suggest 
that Yucca Mountain (and the area immediately around it) does not 
represent an attractive candidate for either random or systematic 
exploratory drilling at this time ((1) Raines, G.L., et al. (eds.), 
``Geology and Ore Deposits of the Great Basin,'' Geological Society of 
Nevada/U.S. Geological Survey, Symposium Proceedings, April 1-5, 1990, 
Reno/Sparks, Nevada, 2 vols., 1991; (2) Schalla, R.A., and E.H. Johnson 
(eds.), Oil Fields of the Great Basin, Reno, Nevada, Geological Society 
of Nevada, 1994; (3) Sherlock, M.G., D.P. Cox, and D.F. Huber, ``Known 
Mineral Deposits and Occurrences in Nevada (Chapter 2),'' in D.A. 
Singer (ed.), ``An Analysis of Nevada's Metal-Bearing Mineral 
Resources,'' Reno, Nevada, Nevada Bureau of Mines and Geology, Open 
File Report 96-2, 1996; and (4) Singer, D.A. (ed.), ``An Analysis of 
Nevada's Metal-Bearing Mineral Resources,'' Reno, Nevada, Nevada Bureau 
of Mines and Geology, Open File Report 96-2, 1996; and (5) U.S. 
Department of Energy, ``Site Characterization Plan, Yucca Mountain 
Site, Nevada Research and Development Area, Nevada,'' Office of 
Civilian Radioactive Waste Management, Nevada, DOE/RW-0199, 9 vols., 
December 1988, pp. 1-256-1-313). Consequently, any consideration for 
the drilling of multiple exploratory boreholes or later drilling of 
more boreholes further increases the speculative nature of the 
intrusion scenario with potentially little increase in understanding 
repository resilience.
    The EPA standards provide for consideration of a single borehole at 
the earliest time that human intrusion into the waste package can occur 
without recognition by the drillers. The Commission believes this is an 
appropriate test for evaluating repository resilience. Moreover, the 
suggested alternative to evaluate multiple intrusions for the human 
intrusion calculation fails to reflect the purpose of the human 
intrusion calculation, that is to test the resilience of the 
repository, not to evaluate the speculative issue of frequency of the 
intrusion.
Intrusion Scenario
    The public comments on part 63 point out the need to clarify 
certain aspects of the prescribed human intrusion event at proposed 
Sec. 63.113(d) with respect to the effects of human intrusion on the 
contents of the waste package. Consistent with current drilling 
practices, it can be reasonably assumed that material inside the waste 
package that is intercepted by the borehole would be taken to the 
surface. Proposed part 63 stated the borehole ``extends to the 
saturated zone, and is not adequately sealed.'' Some commenters 
suggested that particulate HLW inside the waste package would be free 
to fall to the saturated zone inside the inadequately sealed borehole. 
The Commission did not intend to imply that, contrary to current 
drilling practices, an inadequately sealed borehole would allow 
particulate waste to fall directly to the saturated zone. However, an 
inadequately sealed borehole would likely allow water to readily enter 
the waste package; release of radionuclides from the waste package by 
and in water, and transport of these radionuclides to the saturated 
zone by way of the borehole rather than through geologic units that 
could potentially retard the transport of radionuclides. NRC has 
clarified this point at Sec. 63.322(e) and (f) in the final rule.
Exposure Pathways
    Human intrusion has the potential for releasing particulate HLW to 
the surface with drill cuttings or providing a fast pathway for 
radionuclides to be transported to the saturated zone by water (e.g., 
water enters the waste package, releases radionuclides, and transports 
radionuclides by way of the borehole to the saturated zone). NAS 
concluded, and the Commission agrees, that analysis of the risk to the 
public or the intruders (i.e., drilling crew) from radioactive drill 
cuttings left unattended at the surface for subsequent dispersal into 
the biosphere would not fulfill the purpose of the human intrusion 
calculation because it would not show how well a particular repository 
site and design would protect the public at large. Rather, an analysis 
of the hazard of particulate HLW left on the surface would be dominated 
by assumptions subject to significant speculation and uncertainty 
regardless of the particular site or design under evaluation. 
Additionally, the release to the surface represents a one-time release 
with no long-term effect on the repository barriers. Alternatively, 
releases to the ground-water pathway can be adversely influenced over a 
long period of time by an intrusion event that affects barriers of the 
repository (see the discussion on barriers). Therefore, an appropriate 
test of the resilience of the repository is an evaluation of the 
effects of intrusion on releases in the ground-water pathway.
    Issue 2: Is a quantitative comparison between the individual dose 
limit and the results of the stylized human intrusion calculation 
appropriate for evaluating the impact of human intrusion?

[[Page 55762]]

    Comment. Commenters questioned the value of comparing the results 
of what is essentially a deterministic ``bounding'' calculation for 
human intrusion with that of the probabilistic (risk) analysis of 
overall repository performance. Because risk is a function of both 
probability and consequence, evaluation of human intrusion, without 
accounting for the probability of the event taking place, must also 
apply judgment as to what constitutes an acceptable consequence. NEI 
suggested that selection of an acceptable consequence limit should be 
guided by the same logic that was used in establishing the proposed 
preclosure licensing requirements for DBEs found at Sec. 63.111. This 
logic sets higher dose limits for those events that are unlikely to 
occur (i.e., Category 2 DBEs) compared with the dose limit for those 
events expected to occur (i.e., normal operations or Category 1 DBEs).
    DOE suggested that the use of a highly speculative human intrusion 
scenario to evaluate the robustness of the repository is inappropriate 
and makes a poor criterion for potentially disqualifying the Yucca 
Mountain site. In particular, DOE noted that designing a repository to 
meet a restrictive human intrusion performance criterion may lead to 
suboptimization of the overall repository design. Therefore, DOE 
recommended that the results of the intrusion calculation be used as a 
qualitative indicator of repository ``resilience.''
    Response. The objective of the human intrusion assessment is to 
inform any Commission decision regarding the need for DOE to reduce 
uncertainties in its estimates of performance or to provide more 
measures to mitigate consequences and protect public health and safety. 
As discussed in the previous response, the Commission is implementing 
the approach for evaluation of human intrusion as specified in EPA's 
final standards. This approach provides DOE flexibility in determining 
the timing of intrusion and sets an annual individual dose limit of 
0.15 mSv/yr (15 mrem/yr).

3.11  Postclosure Aspects of Repository Design

    Issue 1: Should the NRC limit the thermal energy output per unit 
area of the repository?
    Comment. High-level waste (principally spent nuclear fuel) will 
continue to produce thermal energy following its disposal in a geologic 
repository. Host rock temperatures would be affected by the burn-up 
history of the waste, its age, and the density of waste package 
canisters within the repository. The resulting thermal load may result 
in a thermal-mechanical-hydrologic-chemical (T-M-H-C) response in the 
host rock and surrounding geologic setting, and thus may have a 
deleterious effect on repository performance. Given this concern, some 
commenters noted the proposed rule did not adequately account for the 
thermal output of the waste. In particular, some commenters suggested 
that the regulations should place a limit on the thermal output that 
would better ensure safe operation and long-term stability of the 
repository. One commenter even suggested that the waste be allowed to 
cool for 100 years prior to emplacement as a means of addressing this 
potential design issue.
    Response. The Commission believes that it is inappropriate to 
specify a limit on the thermal energy output per unit area of the 
repository in the rule. This proposed regulation is performance-based 
and allows DOE wide latitude in how it designs any potential Yucca 
Mountain repository by requiring DOE to take into account likely site 
conditions, processes, and events expected during the time period of 
regulatory concern. Consequently, as a result of site characterization, 
DOE can be expected to come to some conclusion regarding the 
significance of T-M-H-C coupling to repository performance and account 
for it in both its preclosure design as well as in its postclosure 
performance assessment. The Commission recognizes that DOE is 
evaluating different thermal loading regimes in the context of its 
Supplemental Draft EIS. For its part, the Commission believes that it 
is inappropriate to specify a limit on the thermal energy output per 
unit area in advance of DOE's scientific decision making about the role 
and significance of T-M-H-C coupling at the Yucca Mountain site.
    Issue 2: The repository design should be as robust as reasonably 
achievable.
    Comment. A commenter suggested that although the ALARA principle 
should not be used in calculating doses, it should be used to design 
critical repository structures, systems, and components. By 
incorporating ALARA into the rule, the commenter proposed that the 
performance of certain design features, particularly barriers, would be 
optimized and made as robust as reasonably achievable.
    Another commenter suggested that NRC should require that engineered 
barriers be designed to account for an oxidizing environment. The 
commenter stated that a ceramic waste package may function more 
effectively than a metal waste package in an oxidizing environment. One 
commenter was concerned that exceeding the Nelson limits could result 
in catastrophic failure of the waste package.
    Finally, a commenter suggested that a repository with a natural-
ventilation system may be safer and more sound. The commenter suggested 
that this design approach may be safer than complete closure of the 
repository.
    Response. The Commission considers that part 63, as written, will 
ensure an adequate design and has not revised the proposed rule on this 
matter.
    With regard to the public comment on the use of ALARA, in its 1995 
findings and recommendations, NAS noted that there is no scientific 
basis for incorporating the ALARA principle into NRC's postclosure 
requirements. In summary, its reasoning was that deep geologic 
disposal, by its very nature, was ALARA, and there were few 
technological alternatives in repository design. They also noted that 
it would be problematic to evaluate compliance with the application of 
ALARA principles in the postclosure phase of the repository. The 
Commission agrees with NAS in this regard.
    With regard to the comment concerning the potential oxidizing waste 
package environment, the Commission is aware of this concern and notes 
that, as the repository developer, the responsibility for designing an 
adequate engineered barrier system rests with DOE. As part of its 
responsibilities, DOE is required by the regulations to take into 
account applicable engineering limits, as well as likely site 
conditions, processes, and events, including those driven by thermal 
loads, when designing the waste package. As a result of its 
investigations, DOE is expected to reach some conclusion regarding the 
significance of the thermal pulse and its coupled effects on waste 
package lifetime. Thus, because DOE has some flexibility in how to 
design the repository and how it will allocate performance among the 
various natural and engineered barriers, DOE will have some flexibility 
in the choice of materials used to fabricate the waste package.
    Lastly, with respect to the issue of repository ventilation, 
inasmuch as proposed part 63 is nonprescriptive, DOE has the 
responsibility to determine how to best design the geologic repository 
so that it complies with performance objectives. As noted above, DOE 
will be required by the regulations to take into account likely site 
conditions, processes, and events expected, including those driven by a 
thermal pulse. As a result of its

[[Page 55763]]

investigations, DOE would come to some conclusion regarding the 
significance of the thermal pulse to repository performance and account 
for such significance in both its preclosure design as well as in its 
postclosure performance assessment. For its part, the Commission will 
independently review this information in any potential license 
application, including the significance of thermal loading on the 
repository and how it has been accounted for in its design and in the 
context of overall performance of the repository, to ensure that the 
performance objectives are met.
    Issue 3: Will NRC have sufficient information to evaluate DOE's 
repository design?
    Comment. One commenter expressed the view that the amount of 
information being requested at Sec. 63.21(c)(4)(i) in the proposed rule 
[moved to Sec. 63.21(c)(3)(ii) in the final rule], the description and 
discussion of the engineered barrier system, is insufficient and 
inadequate for the NRC staff's requisite review. It was recommended 
that this section of the rule be expanded to include the requirements 
that DOE include detailed design drawings, including specifications and 
flow sheets for all manufacturing processes, etc., as part of any 
potential license application. One commenter asked whether the NRC will 
have access to classified information from other governmental agencies.
    Response. The Commission believes that part 63 requires DOE to 
submit sufficient information to allow NRC to perform the necessary 
review but has revised the proposed rule to specify the level of detail 
required.
    The rule requires that the general information of the license 
application shall include ``* * * a description and discussion of the 
engineered barrier system. * * *'' The types of information to be 
included in that ``description and discussion'' are currently being 
identified by the NRC staff as part of the development of the NRC's 
YMRP. Consistent with the rule, this review plan will identify the 
expected content of any potential license application. The guidance 
ensures that any potential license application submitted by DOE 
contains the information necessary for docketing and review by the NRC 
staff. However, to better assure that the information submitted by DOE 
is consistent with the level of detail being sought for the GROA design 
description for preclosure, the proposed rule has been revised to 
require that the design description include dimensions, material 
properties, specifications, and analytical and design methods used, 
along with any applicable codes and standards.
    With regard to the comment on NRC access to classified information, 
all information (including classified information) used by DOE to 
support its license application is subject to NRC review. The 
Commission is capable of receiving, handling, and storing classified 
information.

4  General Requirements

4.1  Quality Assurance

    Issue 1: Would the NRC rule weaken or undo the requirement that DOE 
systematically record its decisions that significantly concern safety, 
how those decisions were made, and what factors influenced them?
    Comment. A number of comments expressed a concern that the NRC rule 
would weaken or undo the requirement that DOE systematically record its 
decisions that significantly concern safety, how those decisions were 
made, and what factors influenced them. The commenters further stated 
that systematic accountability on scientific and engineering decisions 
related to safety must be upheld.
    Response. The regulations, while risk-informed and performance-
based, contain provisions that require DOE to monitor and report on the 
types of potential concerns raised in this comment. These include 
reports on site characterization activities (Sec. 63.16); construction 
records (Sec. 63.72); potential site, design, and construction 
deficiencies (Sec. 63.73); the implementation of a program of 
continuing performance confirmation (Secs. 63.131-63.134); and the 
application of a rigorous QA program to site characterization, design, 
construction, and operations (Secs. 63.141-63.144).
    Issue 2: Should the quality assurance program requirements 
contained in part 60 remain intact for part 63?
    Comment. A number of comments identified a need for the QA 
requirements contained in part 60 to be applicable for part 63.
    Response. The QA requirements initially proposed in Subpart G, 
``Quality Assurance,'' to part 63 required that the licensee implement 
a QA program that meets the applicable requirements of Appendix B 
(``Quality Assurance Criteria for Nuclear Power Plants and Fuel 
Reprocessing Plants'') to part 50. However, rather than referencing 
Appendix B to 10 CFR part 50, as was done in the proposed rule, the 
final rule has incorporated quality assurance requirements from 
Appendix B that are specifically applicable to a geologic repository. 
Further, additional requirements are added in a new Sec. 63.144 to 
address the controls that a licensee will have to meet for changing an 
NRC-approved QA program description.
    Issue 3: Should there be requirements for qualification of data 
that existed prior to the implementation of QA programs?
    Comment. One commenter expressed a concern that there are no 
requirements in the proposed rule to provide for the qualification of 
data that existed prior to the implementation of the QA program used by 
DOE.
    Response. The Commission believes that the controls in 
Secs. 63.141, 63.142, 63.143, and 63.144 are adequate. Based on these 
requirements, data related to structures, systems, and components 
important to safety, to design and characterization of barriers 
important to waste isolation, and to activities related thereto are 
subject to the applicable requirements of Appendix B to 10 CFR part 50 
as incorporated into 10 CFR part 63. These provisions require DOE to 
evaluate data required to support its license application. If data 
related to structures, systems, and components important to safety, to 
design and characterization of barriers important to waste isolation, 
and to activities related thereto have not been collected in accordance 
with a QA program that meets these requirements, DOE would be required 
to show that such data have been qualified for its intended use.
    The NRC recognized that some data supporting a license application 
for a high-level waste repository may not have been initially collected 
under a part 60, subpart G, QA program. In February 1987, the NRC 
published NUREG-1298, ``Qualification of Existing Data for High-Level 
Nuclear Waste Repositories.'' NUREG-1298 provides guidance on the use 
and qualification of data not initially collected under a Subpart G QA 
program.
    Issue 4: Should the NRC conduct an inspection to verify proper 
execution of QA programs? What additional steps will the NRC take to 
ensure that problems which occurred during site characterization will 
not occur after a license is granted (will there be requirements for 
NRC inspections)?
    Comment. Commenters suggested that the regulations should include a 
requirement for NRC to conduct inspections to verify proper execution 
of the DOE QA program and that there should not be a strict reliance 
upon DOE to implement the program properly. Commenters also expressed a 
concern that the problems occurring during site characterization would 
continue after NRC granted a license to DOE. The

[[Page 55764]]

question was asked, ``What additional steps will the NRC take to ensure 
that these same problems do not occur after a license is granted?'
    Response. DOE is presently undertaking a comprehensive program that 
includes the proper steps to correct its QA program deficiencies, 
although some implementation issues remain to be resolved. Section 
63.75, ``Inspection,'' requires, in part, that DOE allow the NRC to 
inspect the premises of the GROA at the Yucca Mountain site and 
adjacent areas to which DOE has right of access. Further, Sec. 63.75 
requires that DOE afford any NRC resident inspector assigned to the 
Yucca Mountain site or other NRC inspectors assigned 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. If NRC were to issue a 
license to DOE, NRC would periodically perform inspections of selected 
DOE activities at the Yucca Mountain site, at DOE support facilities, 
and at DOE subcontractor facilities to ensure that DOE's QA program is 
being effectively implemented. The number and depth of the inspections 
would be based on: the risk significance of the structures, systems, or 
components; activities related to these structures, systems or 
components; and DOE's past performance.
    Issue 5: Should the NRC require the use of Part 2.7 of NQA-1 or a 
similar standard for software QA?
    Comment. A comment stated that it was proper to use Appendix B for 
QA requirements applicable for part 63. However, the commenter noted 
that Appendix B is weak regarding computer QA software and that the NRC 
should use Part 2.7 of NQA-1 or a similar standard for software QA.
    Response. The proposed rule has been revised to emphasize that the 
QA program description needs to include how the requirements of 
Appendix B will be satisfied. In the final rule, Sec. 63.143, 
``Implementation,'' states: ``DOE shall implement a quality assurance 
program based on the criteria required by Sec. 63.142.'' As discussed 
in Sec. 63.142, DOE's QA program would be applicable to all structures, 
systems, and components important to safety, to design and 
characterization of barriers important to waste isolation, and to 
activities related thereto. Further, these activities include site 
characterization, facility and equipment construction, facility 
operation, performance confirmation, permanent closure, and 
decontamination and dismantling of surface facilities. Sections 63.142 
and 63.21(c)(17) (Sec. 63.21(c)(11) in the proposed rule) have been 
changed to specifically require that the DOE QA program describe how 
the QA criteria contained in Sec. 63.142 will be satisfied.
    Presently, the DOE QA program for the Yucca Mountain site 
characterization (DOE Document No. DOE/RW-033P, Revision 8, dated June 
5, 1998) includes a discussion of how the applicable requirements of 
Appendix B will be satisfied. Supplement 1, ``Software,'' to DOE/RW-
033P describes the QA controls for software and addresses controls such 
as: (1) Software life cycles, baselines, and controls; (2) software 
verification and validation; (3) software configuration management; (4) 
defect reporting and resolution; (5) control of the use of software; 
and (6) software documentation. The software controls described in 
DOE's QA program were reviewed by the NRC and found acceptable. 
Although Sec. 63.142 in the final rule does not specifically address 
software QA, it does require that the QA controls be applied to certain 
design and analysis activities. By inference, software used for such 
activities would be subjected to the applicable requirements of 
Sec. 63.142. The NRC will provide, as necessary, additional guidance 
for software QA in the YMRP that may include elements similar to those 
in existing standards such as Part 2.7 of NQA-1. The level of detail 
for software QA in Part 2.7 of NQA-1 is considered inappropriate for 
inclusion in the rule.
    Also, as a result of this and other comments, the final rule does 
not reference Appendix B, but incorporates Appendix B, with appropriate 
modifications, to address its applicability to the high-level waste 
repository.
    Issue 6: The applicability of the QA program is not clear. What 
does safety include?
    Comment. One comment identified a concern that the applicability of 
the QA program was unclear and that he believed the QA program was 
applicable to all items and activities important to the isolation of 
radioactive waste at Yucca Mountain and suggested adding text to Part 
63 to better define the applicability of the QA program.
    Response. The QA program applies to all structures, systems, 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, acquisition 
and analysis of samples and data, scientific studies, performance of 
tests and experiments, controlling geological and engineering materials 
samples, facility design and equipment construction, facility 
operation, performance confirmation, permanent closure, and 
decontamination and dismantling of surface facilities. These terms are 
defined in Sec. 63.2.
    Based on this discussion, the NRC considers the applicability of 
the QA program to be adequately described in subpart G to part 63. 
Because proposed part 63 referred to Appendix B for QA requirements and 
Appendix B does not use the terms important to safety and important to 
waste isolation, requirements from Appendix B have been incorporated 
into final part 63 and modified accordingly to address their 
applicability to the high-level waste repository.
    Issue 7: Should Part 63 contain QA program change controls similar 
to those found in Sec. 50.54(a), and should the proposed Sec. 63.44 
change control process be applicable for QA program changes?
    Comment. DOE identified a problem with proposed part 63 
requirements for controlling changes to the QA program and recommended 
that requirements similar to those contained in Sec. 50.54(a) be used. 
DOE correctly pointed out that the NRC stated, in the discussion 
accompanying the final rule for Part 50 concerning changes to QA 
programs (64 FR 9030; February 23, 1999), that ``use of 10 CFR 50.59 
criteria for QA program changes is not appropriate.'' DOE pointed out 
that, as written, proposed part 63 would permit QA program changes to 
be controlled in accordance with requirements similar to Sec. 50.59 (as 
permitted by Sec. 63.44). DOE suggested text changes to implement its 
comments. DOE also expressed a concern that as proposed, the location 
of Sec. 63.21(c)(11) would cause the QA program description contained 
in the Safety Analysis Report to be subject to the change controls 
required by Sec. 63.44.
    Response. The Commission agrees that the use of the criteria 
specified at Sec. 63.44 is not appropriate for changes to the QA 
program description included in the Safety Analysis Report. We also 
agree that the rule should identify change control requirements 
applicable to the licensee's QA Program and that those requirements 
should be similar to those contained in Sec. 50.54(a)(3). The proposed 
rule has been revised to specifically address change control 
requirements for QA program descriptions.
    We disagree that Sec. 63.21(c)(11) should be relocated to 
Sec. 63.21(b) because the QA program description is required to

[[Page 55765]]

specifically describe how the requirements of Sec. 63.142 will be 
satisfied. By adding specific requirements in Secs. 63.44 and 63.144 
for the control of changes to the QA program description, the 
Commission believes it has resolved the expressed concern for 
relocating Sec. 63.21(c)(11).

    Note: The text at Sec. 63.21(c)(11) in the proposed rule is 
specified at Sec. 63.21(c)(17) in the final rule due to reordering 
of Sec. 63.21 to achieve a more consistent order with the required 
analyses.

    Issue 8: How will NRC ensure DOE properly implements its QA program 
and assures the quality of data it will use to support a license 
application?
    Comment. A number of comments related to what actions the NRC would 
take to ensure that DOE is properly implementing its QA program and 
qualifying data.
    Response. In early 1999, the NRC staff established a QA Task Force 
to review and evaluate the DOE QA program. The Task Force was created 
to address acknowledged concerns regarding the effective implementation 
of the DOE QA program. This task force includes a Senior QA Engineer, 
the NRC Onsite Representatives, and the CNWRA QA Director, under the 
direction of the Division of Waste Management (DWM) Division Director. 
The Task Force has been active in reviewing DOE's progress and issues.
    With respect to data qualification, DOE has initiated corrective 
actions for the data qualification problems documented in 1998 and 
1999. In September 1999, DOE committed to have 100 percent of all data 
fully qualified by the time of license application, should DOE submit a 
license application. DOE has made significant progress in confirming 
the adequacy of data collected before June 1999. In January 2001, DOE 
had qualified 80 percent of these data. As of June 13, 2001, DOE had 
qualified 86 percent of the data supporting the potential license 
application. Further, during the June 13, 2001 NRC/DOE Quarterly QA 
Breakout Session Meeting, DOE reported that its goal was to have all 
data fully qualified by site recommendation.
    In late spring of this year, NRC and DOE identified further QA 
problems, this time affecting the processes controlling software 
verification and model validation. DOE acknowledged a need to revise 
and enhance some of its procedures, such as those controlling software 
development and model validation, and to provide needed training to its 
personnel. Further, DOE is evaluating traceability and transparency 
problems in its technical reports. The QA staff of DOE and their 
contractors have been successful in identifying the QA program 
deficiencies in the various participants' programs and, in many cases, 
highlighting the repetition of similar deficiencies. In the past, 
inadequate corrective action was taken, and the DOE organizations 
responsible for correcting the deficiencies were not held accountable. 
NRC has impressed upon DOE that correction of the QA program 
deficiencies is essential to any potential licensing of the Yucca 
Mountain repository and we are taking steps to ensure that NRC is able 
to evaluate the effectiveness of DOE action to correct the problem.
    During fiscal year 2000 and through June 2001, the NRC staff 
evaluated the implementation of DOE's QA program by: (1) Continuing 
observation of DOE performance-based audits; (2) daily overviews by NRC 
Onsite Representatives assigned to the Yucca Mountain Project office in 
Las Vegas, Nevada; (3) enhanced participation of NRC's technical staff 
in activities at the various DOE facilities; and (4) interfacing with 
DOE during technical exchanges and management meetings. Through these 
activities, we are encouraged that many of the deficiencies are being 
corrected by DOE. Further, we have observed that DOE is continuing to 
adequately identify, process, and correct new problems. NRC believes 
its aggressive overview activities provide the ability to adequately 
evaluate whether the DOE QA program will continue to be effectively 
implemented.

4.2  Changes, Tests, and Experiments

    Issue 1: Should the Commission adopt alternative criteria for 
changes, tests, and experiments?
    Comments. Commenters who addressed the change process issue were 
generally supportive of applying alternative criteria, noting that the 
alternative criteria offered at Sec. 63.44 were useful in clarifying 
the issues involved in evaluating the effects of changes, tests, and 
experiments on license conditions. Nonetheless, several commenters 
noted that the alternative criteria retained some terms that are 
ambiguous and that could be interpreted subjectively, and recommended 
that these terms be avoided or defined in the final rule.
    Response. For nuclear reactors, ISFSIs, and holders of a 
certificate of compliance for a spent fuel storage cask, the Commission 
recently amended its regulations concerning the authority of these 
licensees and certificate holders to make changes to the facility or 
operating procedures, or to conduct tests or experiments, without prior 
NRC approval (64 FR 53582; October 4, 1999). The final rule clarified 
the specific types of changes, tests, and experiments conducted at a 
licensed facility and revised the criteria that must be used to 
determine when NRC approval is needed before such changes, tests, or 
experiments are made. The final rule also added certain definitions for 
terms that have been subject to differing interpretations. Requirements 
comparable to those recently amended were proposed at Sec. 63.44 for a 
geologic repository at Yucca Mountain. In the Supplementary Information 
accompanying the proposed criteria, the Commission expressed its desire 
to establish a uniform policy approach for addressing the change 
process issue. To that end, the Commission sought comment on the 
suitability, for a repository at Yucca Mountain, of an approach 
substantially equivalent to that proposed for nuclear reactors and 
ISFSIs (63 FR 56098; October 21, 1998). Having taken into account the 
comments received on this approach for other NRC-licensed facilities 
and as applied to a potential repository at Yucca Mountain, the 
Commission is adopting final criteria for Sec. 63.44 that are 
comparable, but not identical, to those recently applied to reactors 
and spent fuel storage facilities. Departures from the criteria applied 
to reactors and spent fuel storage facilities were made to reflect 
differences between the repository and such facilities (e.g., 
replacement of ``facility or cask design'' with ``geologic repository 
operations area and design,'' and of ``importance to safety'' to 
``importance to safety and important to waste isolation''). Other 
departures were necessary to reflect different administrative 
requirements of part 63 (e.g., requirement that the Safety Analysis 
Report be updated rather than replaced with a Final Safety Analysis 
Report). Less obvious changes were needed to reflect the risk-informed, 
performance-based nature of the part 63 criteria, and the fact that 
part 63 contains fewer prescriptive requirements (e.g., design basis 
limits).
    Issue 2: Should the proposed, or alternate, requirements for 
changes, tests, and experiments at Sec. 63.44 apply to the contents of 
the entire license application?
    Comment. Some commenters felt that the requirements at Sec. 63.44 
should apply to the contents of the entire license application to 
ensure that the license application is maintained as a current 
reference document for describing activities at the geologic 
repository. Not all commenters agreed,

[[Page 55766]]

however, as some asserted that the proposed requirements should not 
apply to certain types of information that were unlikely to change 
(e.g., General Information) or that which is already subject to control 
under separate NRC requirements incorporated by reference in part 63 
(e.g., parts 72, 73, and 74).
    Response. The Commission intends to apply these criteria to the 
contents of the Safety Analysis Report (as updated). As the Commission 
noted in the Supplementary Information provided with the proposed 
regulations, the purpose of the criteria for changes, tests, and 
experiments is to ensure that the level of safety documented in the 
original licensing basis (i.e., the Safety Analysis Report) is not 
eroded by subsequent modifications to the facility or operating 
procedures. Changes to other portions of the license application, 
provided under Sec. 63.21(b), that have the potential to affect safety, 
i.e. the physical protection plan, the safeguards contingency plan, the 
security organization personnel training and qualification plan, along 
with the material control and accounting plan, are already subject to 
update and change control requirements elsewhere in NRC regulation (at 
parts 72, 73, and 74). Furthermore, as discussed earlier (under Quality 
Assurance), the Commission is adding additional requirements so that 
changes to DOE's QA program will be subject to explicit requirements at 
Sec. 63.144.
    Issue 3: Should specific modifications be made to the rule to 
exclude from reconsideration issues that have no bearing on public 
health and safety and to constrain NRC backfitting of the repository 
design after construction is authorized or imposition of additional 
tests under Sec. 63.74?
    Comment. One commenter recommended that once an issue is considered 
resolved for the purposes of the issuance of a license to commence with 
waste emplacement operations, license to amend for permanent closure, 
or license termination, it should not be subject to reevaluation by the 
Commission (and the ASLB) unless it can be demonstrated that the issue 
has a bearing on public health and safety, common defense and security, 
or the environment. To implement this proposal, alternative regulatory 
language was recommended to Secs. 63.41, 63.51, and 63.52.
    Consistent with other NRC regulations, the Commission should 
include provisions for backfitting of the repository design as well as 
any additional tests required under Sec. 63.74. Specific regulatory 
language was recommended, and it was suggested that these new 
additional requirements would apply only following the issuance of a 
construction authorization. The commenter asserted that backfits should 
only be allowed under two conditions: (1) Where there would be a 
substantial increase in public health and safety; and (2) where the 
direct and indirect costs of the backfit are justified in view of this 
increased protection. In proposing backfits, the commenter recommended 
that the Commission first perform analyses that are systematic and 
documented.
    DOE commented that regulatory changes may be needed to ensure that 
issues closed at the construction authorization stage would not be 
reopened at the receipt and possession stage absent significant new 
safety related information. DOE felt that such a change would allow NRC 
and DOE to keep their focus on the unresolved issues important to 
public health and safety. DOE understands that this change would need 
to be addressed in a subsequent rulemaking on the licensing process.
    Response. The Commission agrees that the focus of a risk-informed, 
performance-based regulatory approach should be on those issues bearing 
on public health and safety, common defense and security, and 
protection of the environment. Clearly, the recently-adopted, generic 
approach (adapted in this rule for the repository) for defining a 
threshold of safety significance for changes, tests, and experiments, 
illustrates NRC's desire to confine its regulatory attention and 
resources to issues bearing on its regulatory responsibilities. That 
being said, however, the issue of imposing backfitting constraints on 
the Commission itself, as it proceeds to evaluate the license 
application for a proposed repository at Yucca Mountain, was not 
evaluated in developing the proposed part 63 criteria, and is therefore 
beyond the scope of this rulemaking.
    Issue 4: How will DOE document its decision making as new 
information is obtained for the site?
    Comment. No specifics are given regarding how the rule could be 
modified to address this concern. However, commenters suggested that in 
light of a proposed regulation that is performance-based, there is the 
potential for DOE's decision making related to safety issues to become 
less than transparent. The view expressed in this comment is that there 
needs to be transparency in safety-related decision making in order to 
have accountability for engineering and scientific decisions.
    Response. The Commission agrees with the comment with regard to the 
importance of transparency and accountability of all safety significant 
decisions made in developing and licensing a geologic repository. It is 
for this very reason that part 63 includes extensive provisions for 
documenting new information and updating the SAR, in order to ensure 
that the technical bases for the Commission's licensing decisions are 
not eroded (Secs. 63.22, 63.24, 63.32, 63.44, 63.46, and 63.51). In 
addition, part 63 also provides for the implementation of performance 
confirmation and quality assurance programs (subparts F and G), that 
help ensure the soundness of the data, assumptions, and modeling upon 
which DOE bases its safety case, and upon which the Commission bases 
its licensing judgments.

4.3  Land Ownership and Control

    Issue 1: Must the U. S. Department of Energy (DOE) establish its 
ownership, title, or control of the Yucca Mountain site?
    Comment. A number of commenters stated that under the Treaty of 
Ruby Valley of 1863, the Western Shoshone Nation never ceded the Yucca 
Mountain site to the United States and that title to the land therefore 
remains with the Western Shoshone Nation. These commenters further 
argue that all activities conducted by the United States at the Yucca 
Mountain site that are not within the specific privileges granted the 
United States under the Treaty of Ruby Valley constitute an illegal 
occupation of Western Shoshone territory and a violation of Western 
Shoshone sovereignty.
    Response. The NRC is aware that the Western Shoshone National 
Council disputes the claim of the United States to have legal title to 
land that includes the Yucca Mountain site. However, there are Federal 
court decisions which have addressed these land claim issues and which 
are binding on both DOE and NRC. Section 63.121 requires that, before 
NRC licensing of a waste repository at the Yucca Mountain site, DOE 
must establish that the GROA and the site are located in and on land 
that is either acquired land under the jurisdiction and control of DOE 
or lands permanently withdrawn and reserved for DOE's use.
    Issue 2: Does siting a waste repository at Yucca Mountain unfairly 
impose undue risks on the Western Shoshone People or adversely affect 
their culture?
    Comment. Commenters believed that the Western Shoshone People were 
being unfairly asked to accept the risks of a waste repository while 
the benefits

[[Page 55767]]

went to the waste generators. One commenter believed that the Western 
Shoshone culture was being transformed from one of protecting the 
environment to one of being a steward of HLW.
    Response. The Nuclear Waste Policy Amendments Act of 1987 (NWPAA), 
authorizes only Yucca Mountain, Nevada, as a location to be 
characterized as a potential repository site. Part 63 does not site the 
repository at Yucca Mountain. Rather, it provides criteria and 
regulations to provide reasonable assurance that public health and 
safety will be protected if a repository is constructed at this site. 
DOE and the President of the United States are responsible for making a 
site recommendation. If the Yucca Mountain site is recommended and 
Congress allows the recommendation to take effect, DOE is to file a 
license application accompanied by an EIS. To the extent practicable, 
the NRC will adopt DOE's EIS in accordance with the NWPA. In its 
licensing proceeding, the NRC will consider the costs and benefits of 
authorizing construction of a repository.
    Issue 3: Should proposed Sec. 63.121 be revised to require that DOE 
conform to State water law and to acknowledge the responsibilities of 
the Federal Government for compensation when initiating takings?
    Comment. Commenters were concerned about whether DOE must conform 
to State water law to obtain water rights (one commenter indicated DOE 
is required, under State water law, to show beneficial use in order to 
obtain water). A commenter viewed Sec. 63.121 as giving DOE the right 
to take water rights in order to achieve waste isolation and stated 
that the rule must acknowledge the responsibilities of the Federal 
Government for compensation when initiating takings.
    Response. Section 63.121(c)(1) requires DOE to obtain such water 
rights as may be needed to accomplish the purpose of the GROA. The 
``purpose of the geologic repository operations area'' is intended to 
be construed broadly to include the isolation of radioactive wastes 
after permanent closure as well as any water rights needed during the 
period of operations. Whether DOE is subject to State law in obtaining 
any water rights that may be needed for this purpose is a matter to be 
determined by DOE and the State. The NRC does not have the authority to 
require that DOE conform to State law.
    Comment. One commenter suggested that Sec. 63.121(b) directly state 
that additional controls include water rights, instead of specifying in 
Sec. 63.121(c)(2) that water rights are included in the additional 
controls to be established under Sec. 63.121(b).
    Response. The Commission prefers to retain the present format for 
clarity because water rights would be dealt with explicitly in one 
paragraph of Sec. 63.121. ``Controls'' referred to in Sec. 63.121(b) 
would, of course, include water rights.
    Comment. One commenter viewed Sec. 63.121 as giving DOE the right 
to take water rights in order to achieve waste isolation and stated 
that the rule must acknowledge the responsibilities of the Federal 
Government for compensation when initiating takings. This commenter was 
also concerned that the rule permits the spread of radionuclides to 
areas far outside the boundaries of the repository and believes that 
the repository should be designed so that it is not necessary to take 
water rights to achieve waste isolation. Another commenter believed 
that this regulation would allow Yucca Mountain to operate as a delayed 
radioactive waste release facility and not a permanent disposal site.
    Response. Section 63.121 does not give DOE the right to take water 
rights; rather, it requires DOE to have obtained any water rights 
needed to achieve waste isolation. DOE will need to comply with 
whatever laws apply with respect to obtaining any needed water rights. 
The purpose of the regulation is to make sure that DOE is in a position 
to establish appropriate controls outside of the site necessary to 
prevent adverse human actions that could significantly reduce the 
geologic repository's ability to achieve waste isolation. The NRC will 
not license the facility unless there is reasonable expectation that 
releases of radioactivity will remain within regulatory limits.
    Issue 4: Do requirements for land ownership and control of the site 
apply equally to repository operations (preclosure) and long-term 
safety (postclosure) activities?
    Comment. DOE commented that requirements for land ownership and 
control (Sec. 63.121) are not sufficiently clear regarding their 
applicability to preclosure and postclosure activities. The lack of a 
clear distinction between preclosure and postclosure activities could 
imply that DOE must designate the same area for the evaluation of 
design basis events and for postclosure considerations for preventing 
adverse human actions. Part 60 provided flexibility in designating 
areas under preclosure and postclosure activities that should be 
retained in Part 63.
    Response. The Commission agrees with DOE that land ownership and 
control requirements are not sufficiently clear regarding their 
application to preclosure and postclosure activities. The requirements 
have been clarified to indicate that: (1) The GROA 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) DOE has the flexibility to identify and establish additional 
controls for lands outside the GROA necessary to prevent adverse human 
actions that could significantly reduce the geologic repository's 
ability to achieve isolation (postclosure); and (3) DOE has the 
flexibility to identify and establish additional controls for lands 
outside the GROA to ensure the requirements at Sec. 63.111(a) and (b) 
are met. These clarifications have been made in revisions to 
Sec. 63.121 of the final rule.

5  Selected Topics

5.1  Public Out-Reach

    Issue 1: What role do the public meetings serve in the rulemaking 
process?
    Comment. Commenters questioned the use of the public meetings and 
were concerned about how the meeting record would be used in NRC's 
rulemaking process. Many commenters appreciated the efforts the NRC 
made to include the public in the promulgation of part 63. Based on 
listening to NRC staff presentations made at a public meeting, it 
appeared to some commenters that the objective was to convince the 
local populations about the safety of the Yucca Mountain Project and 
that NRC regulations will protect public health. Some commenters 
requested that sufficient time be given for the public to provide 
comments. One commenter asked if the dose limits would be lowered if 
public opinion favored a lower value.
    Response. The purpose of the public meetings was to enhance the 
opportunity for the public to participate in NRC's rulemaking process. 
The public had an opportunity to question the NRC staff about the 
proposed rule and its decision making leading to it, as well as having 
the opportunity to express their views on the rule itself. To 
facilitate public interactions in this process, additional time was 
afforded to the public to comment on the proposed rule. Transcripts of 
the various public meetings were made as a way of accurately recording 
the public's views. These transcripts were later studied by the NRC 
staff so that the public's comments could be identified and responded 
to in this document. The Commission carefully considered the

[[Page 55768]]

issues raised by members of the public at the transcribed meetings, as 
well as the NRC staff's summary of written comments received, as part 
of its deliberations on the final form and content of part 63.
    With regard to whether NRC would consider lowering the dose limits 
if public opinion favored it, the Commission has given serious 
consideration to the views of the public on this matter, and, 
consistent with its obligations under law, has adopted the dose limits 
published by EPA in its standards for Yucca Mountain.
    Issue 2: Will there be more public meetings?
    Comment. Commenters stated that it would be helpful for NRC to 
consider increasing its efforts in the area of public outreach and 
commit to holding more public meetings in the future. Another commenter 
suggested that the NRC program focus should be on public health and 
safety and not on political issues associated with the HLW program.
    Response. The Commission agrees with the recommendation to increase 
its efforts in the area of public outreach. The NRC staff will continue 
to hold public meetings in Nevada. We continue to seek a better 
understanding of the views and concerns of the public on how we can 
best fulfill our independent regulatory responsibility to protect 
public health and safety.
    As far as avoiding political issues associated with the Yucca 
Mountain site, the Commission notes that it has taken no position on 
the suitability of Yucca Mountain to host a potential geologic 
repository. That decision rests with DOE, with the subsequent approval 
of the President and Congress.
    Issue 3: What is the role of NRC's local office in Nevada?
    Comment. Some commenters asked if NRC had a local office in Nevada 
and if there was one, how could the public contact the staff there. One 
commenter suggested that the role of the local office be expanded to 
represent NRC in a manner more visible to the public.
    Response. The NRC maintains a local onsite representative's office, 
with a small staff, in Las Vegas, Nevada, as a means of keeping abreast 
of DOE activities and interacting with other stakeholders. This office 
allows our onsite representatives physical proximity to the site and 
the opportunity to interact on various site characterization 
activities. At this time, the NRC has no plans to expand the size of 
the onsite representative's office. However, the size of the office, as 
well as the scope of NRC's activities conducted there, is subject to 
reexamination. Meanwhile, the public is encouraged to contact our staff 
at the onsite representative's office at: 1551 Hillshire Drive, Suite 
A, Las Vegas, Nevada 89137-1048, Telephone 702/794-5046.
    Issue 4: Should AULGs and EPA be included in the regulations at 
part 63, subpart C, Secs. 63.61-63.65, providing for participation in 
certain NRC regulatory activities?
    Comment. One local government commenter noted that, under the 
NWPAA, there is a legal basis for the participation of affected units 
of local government (AULGs) in activities concerning a potential 
repository at the Yucca Mountain site and asked why AULGs have not been 
included in Sec. 63.61 and subsequent sections dealing with 
participation in regulatory activities. Another local government 
commenter explicitly requested that AULGs be included in the 
requirement for provision of ``timely and complete information'' in 
Sec. 63.61. EPA also requested that it be included in Sec. 63.61(a) 
given its interest in the proper implementation of the standards.
    Response. Section 116(c) of the NWPAA directs DOE to provide 
funding to AULGs so that they may participate in activities required or 
authorized under sections 116 and 117 of the NWPAA. Although these 
activities primarily involve DOE's interactions with the State, 
affected Indian tribes, and AULGs, the Commission believes that it 
would not be inconsistent with the intent of the statute to include 
AULGs at appropriate points in the regulations under part 63, subpart 
C, and has revised the regulations accordingly. The Commission is not 
adding EPA to Sec. 63.61(a) because this provision is consistent with 
section 117(a)(1) of the NWPAA which does not include EPA. However, the 
information provided under Sec. 63.61(a) is available to EPA.
    Issue 5: Should the ``unquestionable legal right to participate as 
a party'' in a repository licensing hearing afforded to the State of 
Nevada and any affected Indian Tribe in proposed Sec. 63.63(a) also 
include affected units of local government (AULGs)?
    Comment. A local government commenter stated that AULGs should have 
the same ``unquestionable legal right to participate as a party'' in a 
repository licensing hearing as is provided to the State of Nevada and 
any affected Indian Tribe in proposed Sec. 63.63(a).
    Response. The Commission agrees. The hearing procedures in the 
current 10 CFR part 2, subpart J, have replaced the hearing procedures 
in 10 CFR part 2, subpart G (except for sections of subpart G 
specifically referenced in Sec. 2.1000) with respect to a repository 
licensing proceeding. Under the subpart J rules for intervention in the 
licensing proceeding, AULGs are permitted to intervene as a matter of 
right (see 54 FR 14938; April 14,1989) in the same way as the State and 
an affected Indian Tribe. Thus, the Commission, in the final rule, has 
corrected the reference to ``Subpart G'' in the first sentence of 
Sec. 63.63(a) to read ``Subpart J'' and has clarified the reference to 
local governments by changing it to ``affected units of local 
government.'' The Commission deleted the final sentence because it does 
not add any right not provided by the first sentence.
    The proposed Sec. 63.63(a) states: ``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.'' This provision is 
modeled on, and virtually identical to, Sec. 60.63(a). Section 60.63(a) 
was incorporated into NRC regulations prior to the Commission's 
adoption of part 2, subpart J, ``Procedures Applicable to Proceedings 
for the Issuance of Licenses for the Receipt of High-Level Radioactive 
Waste at a Geologic Repository'' (subpart J) (54 FR 14925; April 14, 
1989). Section 2.1014(c) of subpart J permits intervention of AULGs in 
a repository licensing proceeding without the need to establish 
``party'' status:

    ``Subject to paragraph (a)(3) of this section, the Commission, 
or the Presiding Officer designated to rule on petitions to 
intervene and/or requests for hearing shall permit intervention, in 
any hearing on an application for a license to receive and possess 
high-level radioactive waste at a geologic repository operations 
area, by an affected unit of local government as defined in section 
2(31) of the Nuclear Waste Policy Act of 1982, as amended, 42 U.S. 
10101.'' [Sec. 2.1014(c) (1999)]

    See also the definition of ``party'' in Sec. 2.1001 which, as 
amended in 1998 (63 FR 71729; December 30, 1998), defines a ``party'' 
to mean the DOE, the NRC staff, the host State, any AULG as defined in 
section 2 of the NWPA, any affected Indian Tribe as defined in section 
2 of the NWPA, and a person admitted under the criteria in Sec. 2.1014. 
These regulations relieve the State, affected Indian Tribes, and AULGs 
from the need to meet the standing requirements in order to be admitted 
as a party in the proceeding. The State, an affected Indian Tribe, and 
an AULG

[[Page 55769]]

must still submit contentions in accordance with the provisions of 
Sec. 2.1014(a)(2)(ii) and (iii), and at least one contention must 
satisfy these requirements, or the State, affected Indian Tribe, or 
AULG shall not be permitted to participate as a party 
(Sec. 2.1014(a)(3) (1999)).
    All the above is in the context of the existing hearing procedures 
in part 2. The Commission recently proposed revisions to part 2 (66 FR 
19610; April 16, 2001). Even under the proposed revisions, however, a 
``party'' in a subpart J proceeding continues to be defined as 
including the host State, any affected unit of local government and any 
affected Indian Tribe, provided that these entities file an acceptable 
contention. Thus, the Commission has not proposed any change to the 
ability of an affected unit of local government to participate as a 
party without the need to meet standing requirements.
    Issue 6: What is the NRC's current approach to explaining the risks 
associated with the Yucca Mountain Project?
    Comment. A commenter was concerned with how the NRC explains the 
risks associated with the Yucca Mountain Repository. The commenter 
stated that NRC bases its explanation of risk-informed regulation on 
comparison to other types of risks, such as exposure from other types 
of hazards or background levels of radiation. This commenter suggested 
that this relative risk explanation is not helpful or persuasive, and 
that the NRC should design a project that does not result in 
radioactive exposures. Other commenters complained that many of NRC's 
public documents, and the proposed rule in particular, are not written 
in language understandable to the public. For example, one commenter 
was confused about the intended meaning of ``individuals with unusual 
habits and sensitivities.''
    Response. The Commission has the responsibility to establish 
disposal criteria that DOE must meet, consistent with the applicable 
environmental standards promulgated by EPA. As part of this 
responsibility, the Commission must explain the level of protection its 
regulations and regulatory programs provide. For its part, DOE, as the 
repository developer, is obliged to site and design the repository such 
that DOE can demonstrate, consistent with NRC regulations, that the 
proposed repository will perform as intended. In reaching any licensing 
decision, the Commission will need to perform an independent audit of 
DOE's analyses that show how DOE has complied with the established 
levels of protection, based on its independent review of DOE's license 
application and other confirmatory information and activities.
    The NRC staff will continue to provide information to explain the 
risks that would be associated with a repository licensed in accord 
with its regulations by using a variety of comparisons. The potential 
health effects arising from any radiation exposure is a very complex 
subject. To provide a context for NRC's proposed criterion of 0.25 mSv/
yr (25 mrem/yr) or EPA's final limit of 0.15 mSv/yr (15 mrem/yr) 
individual dose limit for Yucca Mountain, NRC staff members frequently 
draw comparisons with other dose limits applied in NRC's regulation for 
low-level waste disposal (part 61) as well as with national and 
international recommendations for radiation standards (see discussion 
under Individual dose limit). To provide some context for understanding 
what a radiation exposure at these levels represents, comparisons have 
been made to the values for more ``routine'' radiation exposures (e.g., 
dental x-rays, increased radiation exposure from traveling in a plane). 
These comparisons are used to inform the public, not to persuade them.
    With respect to the meaning of the term ``individuals with unusual 
habits and sensitivities,'' the Commission believes the commenter 
refers to the findings and recommendations of NAS. Both these 
recommendations and final EPA standards require that DOE base the 
characteristics of the representative group for postclosure dose 
calculations (the community in which the RMEI resides) on lifestyles 
and dietary habits (i.e., reliance on well water, extent to which food 
is grown locally, types of foodstuffs eaten) of individuals currently 
living in the Yucca Mountain region. NAS explained that specification 
of the representative group should avoid extreme cases defined by 
unreasonable assumptions regarding the factors affecting dose. NAS also 
stated that a reasonable and practicable objective is 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'' (pp. 51-52, ``Technical Bases for Yucca 
Mountain Standard,'' National Research Council, 1995). Hence, the terms 
``unusual habits'' and ``sensitivities'' were used to exclude 
unreasonable assumptions about the characteristics of a hypothetical, 
future population group or RMEI. The NAS did not use these words to 
imply any judgment with regard to the behaviors or mental state of 
individuals residing near the site today. The Commission will continue 
to strive to explain more clearly the risks associated with the 
potential repository at Yucca Mountain.
    Issue 7: In the future, how is the NRC going to effectively 
communicate the risks of the Yucca Mountain Project to public health 
and safety?
    Comment. One commenter requested one-on-one contact answering calls 
and letters and following through with questions and sending written 
responses. Another commenter was concerned that the people of Nevada 
are not suitably informed about the risks involved with the Yucca 
Mountain Project. Also, one commenter suggested that a bulletin be 
published quarterly or as an insert to a local paper about the Yucca 
Mountain Project. A few commenters were concerned that their fears are 
considered ``irrational'' regarding the safety of the Yucca Mountain 
Project and will not be taken seriously.
    Commenters suggested that NRC use ``local'' sources (e.g., local 
government and libraries) to provide information to the public 
regarding meetings and other information. Information should be written 
in plain English.
    Response. The NRC understands the importance of a strong public 
outreach program. NRC held five public meetings in Nevada during the 
public comment period on proposed part 63. Comments made at those 
meetings were instrumental in NRC deciding to extend the public comment 
period for the proposed rule. However, these meetings also demonstrated 
to NRC that it can improve its public outreach efforts. The NRC has 
held seven additional public information workshops in Nevada since the 
public comment period closed on part 63. We will continue to meet with 
the people of Nevada and continue to seek the public's views on how we 
can carry out our responsibilities in a more effective manner. We also 
intend to keep the public better informed about our independent 
regulatory activities and oversight. The NRC will also continue to work 
on providing displays and fact sheets that use plain English.
    The Commission notes also that DOE maintains three visitor centers 
that are intended to keep the public informed. They are located in 
Beatty, Pahrump, and Las Vegas. DOE also sponsors regular field trips 
to the Yucca Mountain site. DOE maintains an Internet web page with 
information that is regularly updated on activities at the site and 
developments in the program; it can be found at http://www.ymp.gov. 
With regard to the comments proposing that activities and future events 
be

[[Page 55770]]

published in local newspapers, the NRC staff will forward that 
recommendation to DOE. As the repository developer, DOE has the 
responsibility to keep interested members of the public informed about 
activities at the site as well as about the program. The State of 
Nevada, Nye County, Clark County, Eureka County, Inyo County, 
California, and others also maintain web sites with information about 
the Yucca Mountain program. They are located, respectively, at http://www.state.nv.us/nucwaste, http://www.nyecounty.com, http://www.co.clark.nv/us/complan/Nucwaste.htm, http://Yuccamountain.org and 
http://sdsc.edu/Inyo/yucca-pg.htm.
    Finally, the Commission notes that the NRC staff has maintained a 
schedule of meetings with DOE on its Web page (http://www.nrc.gov/nmss/dwm/hlw/htm) for several years. Important NRC documents related to the 
HLW program also are distributed to DOE, the State, Affected Units of 
Local Government, and other stakeholders. Since November 1, 1999, NRC 
has made HLW program documents generated and received available on its 
Public Electronic Reading Room located at http://www.nrc.gov/NRC/ADAMS/index.html. Documents generated prior to November 1, 1999, can 
currently be found at the two designated library reading rooms (in 
Nevada): James R. Dickinson Library, Government Publications 
Department, University of Nevada at Las Vegas, 4505 Maryland Parkway, 
Las Vegas, NV 89154, (702) 895-1572 and Business and Government 
Information Center, University of Nevada Library, University of Nevada, 
Reno, Reno, NV 89557-0044, (702) 784-6500 ext. 257.
    Issue 8: How do the NRC and DOE, both as government agencies, 
maintain a proper relationship, respectively, as the regulator and a 
potential licensee?
    Comment. One commenter was concerned that constant care needs to be 
taken by both NRC and DOE to maintain a relationship that clearly 
delineates between the regulator and the licensee.
    Response. The interactions of the NRC staff and the DOE staff with 
respect to all activities preparatory to DOE's submission of a license 
application are governed by the ``Agreement Between DOE/OCRWM and NRC/
NMSS Regarding Prelicensing Interactions,'' which was initially signed 
in 1983 and was revised in 1998, and by the NRC Staff's Policy 
Statement on Staff Meetings Open to the Public (65 FR 56964; September 
20, 2000). These documents provide that meetings between the two staffs 
will be open to the public as specified in the Policy Statement and 
that management commitments will be documented in correspondence 
subsequent to the interactions. Thus, procedures are in place to ensure 
an appropriate open relationship between the potential regulator and 
the potential licensee.
    Issue 9: Should different DOE organizations active in Nevada be 
required to better coordinate their activities and responses to 
questions from the public?
    Comment. One commenter noted that the different DOE organizations 
operating within Yucca Mountain and the NTS need better coordination 
because the different organizations sometimes provide different answers 
to the same questions.
    Response. The Commission is sensitive to the concern raised here, 
but this comment is beyond the scope of this particular rulemaking. 
This issue falls within DOE's purview as the overall operator of NTS 
and thus should be directed to it.
    The Commission needs reliable information from DOE on its 
activities at Yucca Mountain in order to perform its independent 
regulatory role in the HLW program. DOE will be required to provide 
complete and accurate information for NRC's licensing decision. The 
Commission believes that the NRC licensing process for the repository 
will provide an adequate means to test the accuracy and reliability of 
the information submitted for licensing.
    Issue 10: Where will the DOE license application be available for 
inspection by the public?
    Comment. One commenter noted that the proposed rule (Sec. 63.22) 
stated that copies of the DOE license application will be made 
available for inspection by the public at ``appropriate locations'' 
near Yucca Mountain and inquired as to where these locations would be 
and how they would be determined.
    Response. The determination as to what is an ``appropriate 
location'' has not been made at this time. In all likelihood, such a 
determination will be made in consultation with the State of Nevada and 
AULGs. Moreover, for those individuals who have access to the Internet, 
any potential DOE license application will also be available 
electronically for inspection on the NRC and DOE web pages.
    Issue 11: Who is responsible for oversight and review of DOE's QA 
program?
    Comment. The Western Shoshone Nation objected to DOE undertaking a 
QA program without strict oversight and review by the Western Shoshone 
Nation.
    Response. NRC has the statutory responsibility for oversight and 
review of DOE's QA program for the proposed repository at Yucca 
Mountain. NRC cannot relinquish this authority to other groups or 
individuals. However, the Commission is interested in keeping the 
stakeholders informed of the results of the inspection process, 
including NRC's inspection of DOE's QA program. The Commission is 
interested in approaches for keeping the stakeholders informed and is 
interested in hearing from the stakeholders regarding their ideas for 
potential approaches.

5.2  Other Comments

    Issue 1: Can the NWPA-mandated limit of 70,000 metric ton 
equivalent of uranium (MTU) for the proposed geologic repository at 
Yucca Mountain be exceeded?
    Comment. Several comments were received in this area. Some 
commenters raised the possibility of the mass loading at the repository 
increasing from 70,000 MTU to 105,000 MTU. One commenter is concerned 
that such an increase may be approved by a Congressional action, 
without a scientifically-based recharacterization of the site. It 
appears that this comment was prompted as a result of published 
interviews with DOE officials quoted in June 1999 (in the Las Vegas 
Sun) that up to 105,000 MTU of waste may be destined for the 
repository. The comment concerns the effect of heat on the local 
geosphere given this alternative (higher) volume of waste.
    Similarly, other commenters noted that a DOE report was published, 
which stated that there would likely be two repositories, and that the 
amount of waste emplaced in both would be a total of 126,000 metric 
tons plus 14,000 metric tons of defense waste.
    Recognizing the potential need for additional repository disposal 
capacity, NEI suggested that the reference in Sec. 63.42(d) (Conditions 
of License), to the NWPAA-mandated limit of 70,000 MTU for the proposed 
geologic repository at Yucca Mountain, should be deleted, and just 
refer to NWPA, as amended. This design limit is currently specified in 
legislation for the HLW program. If the legislation were to change, it 
would precipitate a need for an additional Yucca Mountain-specific 
rulemaking. By simply referring to NWPA, as amended, the need for a 
future rulemaking would be obviated if the legislation ever changes.
    Response. The 70,000 MTU limit for the proposed geologic repository 
at Yucca Mountain is mandated by NWPAA. Specifically, NWPAA provides 
that no more than 70,000 MTU

[[Page 55771]]

can be placed in the first geologic repository. Whether the 
statutorily-imposed limit should be changed is an issue for Congress 
and the President to decide. Regardless of the limit, DOE must 
demonstrate in its license application that the types, kinds, and 
amounts of HLW to be disposed in any potential geologic repository at 
Yucca Mountain can be disposed in a way that ensures public health and 
safety. The Commission does agree that referencing the NWPA, as 
amended, is more appropriate than NRC providing the specific value of 
70,000 MTU. The proposed rule has been revised accordingly.
    Issue 2: Should there be specific requirements for postclosure 
monitoring of ground water?
    Comment. Local ground water supplies the domestic and agricultural 
water needs for area residents and, therefore, needs to be part of a 
DOE postclosure monitoring program. The most likely exposure scenario 
to radionuclides released from a potential geologic repository at Yucca 
Mountain would be in the ground water, down-gradient from the site. 
Because of this potential hazard, some commenters expressed the view 
that there is a need for the NRC to require that DOE implement a 
postclosure ground-water monitoring system. It was noted that such a 
system would protect citizens living near the repository by providing 
early warning of the presence of radionuclides in the ground water.
    Response. Consistent with the EnPA, Sec. 63.51(a)(3)(iii) requires 
a program for continued oversight of the repository site after 
permanent closure. One objective of the oversight program is to ensure 
that exposure to individual members of the public does not exceed 
allowable limits. Because the ground-water pathway is the most likely 
exposure pathway, it is expected that ground water would be monitored.
    Issue 3: Would local residents be compensated if radioactive 
contamination, due to transport of HLW to Yucca Mountain or to leakage 
from the repository, damages their health or property?
    Comment. Several commenters were concerned about whether local 
residents would be able to obtain compensation if their health should 
be adversely affected by leaking of radiation from the repository or 
from casks being transported to the repository. They were also 
concerned about whether damage to land or ground water due to 
radioactive contamination or to the lowering of property values would 
be compensated.
    Response. Part 63 does not alter whatever liability the Federal 
Government may have for damage to health or property caused by its 
activities. It is possible that compensation could be available for 
certain types of damage to health or property under Federal law, but it 
would be speculative to suggest that compensation would be available in 
any particular case.
    Issue 4: Over what time period must physical security be maintained 
over the site and how would this be maintained?
    Comment. Some comments were made regarding how security would be 
maintained over the site for very long time periods. One commenter 
asked if the site would be safeguarded against sabotage.
    Response. NRC's regulation requires that DOE will have a system of 
active institutional controls and (passive) site markers, specified at 
Sec. 63.21(c)(18) (Sec. 63.21(c)(15) in the proposed rule) and 
Sec. 63.51(a)(3), that will prevent human intrusion into the repository 
by ensuring physical security indefinitely following permanent closure 
of any potential geologic repository at Yucca Mountain. That being 
said, by its very nature, geologic disposal is intended to provide a 
high degree of physical security by rendering the wastes difficult to 
access owing to their remote location deep underground (i.e., about 300 
meters/1000 feet). As a practical matter, once the repository is 
closed--i.e., by sealing and possibly backfilling the underground 
drifts and access tunnels--the level of effort to reopen the repository 
and gain access to the wastes while preserving radiological safety will 
entail a substantial technical effort and expertise given current 
technology, and any action to do so would likely be detected.
    As regards the potential risk of radiological sabotage to the 
repository during the preclosure phase of operations, the Commission's 
regulations for Yucca Mountain at Sec. 63.21(b)(3) require that 
licensees have in place adequate physical security plans and attendant 
procedures to protect against radiological sabotage, consistent with 
Sec. 73.51--NRC's requirements for the physical protection of stored 
spent nuclear fuel and high-level radioactive waste. In light of the 
terrorist attacks of September 11, 2001, the Commission has directed 
the staff to conduct a comprehensive reevaluation of NRC physical 
security requirements. If this effort indicates that NRC's regulations 
or requirements warrant revision, such changes would occur through a 
public rulemaking or other appropriate methods.
    Issue 5: Terminology in the rule is not always as clear as it 
should be.
    Comment. DOE indicated instances where particular words or phrases 
in Part 63 lacked clarity. The following specific changes to the 
proposed rule were suggested by DOE:
    1. The phrase ``* * * could adversely affect safety * * *,'' found 
at Sec. 63.32(b)(3), should be replaced with ``* * * could constitute a 
substantial safety hazard * * *'' as defined in part 21 of this 
chapter. (The phrase ``substantial safety hazard'' is well defined in 
NRC's part 21 regulations; there is no need to introduce a new, 
undefined term such as ``adversely impact safety''.)
    2. DOE indicated that the location of the compliance point could be 
misinterpreted and recommended that the rule use ``the junction of U.S. 
Route 95 and Nevada Route 373'' and delete ``near Lathrop Wells, 
Nevada.''
    Response. The Commission inadvertently used two different phrases 
(``could adversely affect safety'' [Sec. 63.32(b)(3)] and ``[b]e a 
substantial safety hazard'' (Sec. 63.73(a)(1))) when describing 
requirements for reporting deficiencies in proposed part 63. The 
Commission's intent was to specify a general level of concern (i.e., 
could adversely affect safety) for deficiencies that would require 
reporting to the NRC as specified at Secs. 63.32(b)(3) and 63.73(a)(1). 
Although the proposed rule used the phrase ``substantial safety 
hazard'' (Sec. 63.73(a)(1)), it was not the Commission's intent to 
imply the reporting requirements under Sec. 63.73 were to be construed 
as the same as the part 21 requirements for reporting of defects. 
Accordingly, the Commission will clarify its intent by replacing ``[b]e 
a substantial safety hazard'' with ``adversely affect safety at any 
future time,'' and identify specific events and conditions that require 
reporting by reference to Sec. 72.75 at Sec. 63.73(c).
    The location of the RMEI, for purposes demonstrating compliance 
with the postclosure performance objectives, is in the accessible 
environment above the highest concentration of radionuclides in the 
plume of contamination. EPA standards for Yucca Mountain define 
``accessible environment'' as any point outside of the ``controlled 
area.'' To be consistent with EPA's standards, the Commission has 
incorporated EPA's definitions of ``accessible environment'' and 
``controlled area'', as specified at 40 CFR 197.12, into subpart L of 
part 63.
    Issue 6: Address the technical skills of the NRC staff to regulate 
a potential geologic repository at Yucca Mountain Project.

[[Page 55772]]

    Comment. During the June 15, 1999, public meeting in Amargosa 
Valley, Nevada, one individual questioned the NRC staff's understanding 
of the fundamentals of the Yucca Mountain Project. This individual 
questioned how the NRC can regulate such a highly technical process 
without having its own highly technical personnel on staff. Commenters 
asked if NRC had its own experts or if NRC had to rely solely on 
information collected and developed by DOE. Although this comment is 
beyond the scope of the rulemaking, it questions the core technical 
expertise of the NRC staff to promulgate and implement this rule.
    Response. The NRC (and its predecessor agency, the Atomic Energy 
Commission) has been regulating civilian uses of radioactive materials 
for nearly five decades. With increased awareness in the area of 
radioactive waste management, beginning in the late 1970s, the 
Commission's regulatory purview was expanded to include the disposal of 
HLW. As a complement to the existing NRC staff expertise in regulating 
nuclear activities and facilities, the Commission recruited and 
maintained a core staff with scientific expertise in those areas 
generally recognized to be important to radioactive waste management--
the earth sciences, applied mathematics, geotechnical and materials 
engineering, and health physics. In the late 1980s, the Commission 
created a federally-funded research and development center, the CNWRA, 
to provide dedicated, conflict-of-interest-free technical assistance as 
a further complement to its scientific expertise.
    In order to maintain an independent technical capability of the 
highest order, the NRC staff and its technical assistance consultants 
have been engaged over the years in scientific investigations and 
research necessary to understand how to properly regulate the 
management of radioactive wastes. The results of these efforts are 
widely published in the technical literature. In addition to these 
efforts, when there is a common interest, the NRC staff and its 
technical assistance consultants monitor or engage in international 
activities related to the regulation of radioactive wastes or the 
advancement of technical capability in radioactive waste management. To 
oversee these activities, the Commission's ACNW makes recommendations, 
when appropriate, to adjust or expand the technical capabilities needed 
by its staff.
    In summary, the Commission believes that the qualifications and 
knowledge of the NRC staff and its technical assistance consultants 
with respect to the important technical aspects of the Yucca Mountain 
Project provide them with the credentials, skills, and state-of-the-art 
knowledge that are necessary and appropriate to ensure that NRC 
regulatory decisions with respect to public health and safety are made 
with the highest degree of scientific competence.
    Issue 7: Does Yucca Mountain fail to comply with one of the 
[technical] criteria in the existing (Part 60) rule?
    Comment. A commenter noted that it appears from DOE analyses that 
the Yucca Mountain site does not comply with one of the specific 
criteria in the existing rule, not the proposed new rule.
    Response. DOE has not submitted an analysis to NRC for review that 
would fit the description of this comment. In addition, this final rule 
amends 10 CFR 60.1 to clearly state that Part 63, not Part 60, applies 
to licensing a disposal facility at Yucca Mountain, Nevada.
    Issue 8: How should the material control and accounting program 
balance the need for inspections with worker exposures?
    Comment. One commenter suggested that the program for maintaining 
material control and accounting should balance the need for periodic 
inspections with the potential for increased exposures of the 
inspectors. It was recommended that DOE and NRC should agree on how and 
when to terminate material control and accounting surveillance.
    Response. The Commission agrees with the comment that workers 
should be protected from unnecessary doses due to repository 
operations. Although the requirement for conducting a physical 
inventory of HLW (reference to Sec. 72.72 at Sec. 63.78) extends over 
the operational period of the repository, the regulations provide 
flexibility to the Commission in determining the frequency for 
conducting the physical inventories. Determination of an appropriate 
frequency for conducting the inventories will consider such things as 
DOE's proposal for the material control and accounting program, the 
requirements for material control and accounting, and safety of 
inspectors. It is anticipated that the frequency for conducting 
inventories could vary due to significant changes in operations (i.e., 
emplacement versus post-emplacement activities) over the long 
operational period (e.g., 100 years) for the repository. The Commission 
considers a decision on how and when to terminate material control and 
accounting to be unnecessary and premature. The regulations provide the 
necessary flexibility for the Commission to determine how and when to 
terminate the material control and accounting that would consider the 
important issue raised by the commenter.
    Issue 9: All references to ``* * * decontamination or dismantlement 
* * *'' of geologic repository facilities in the proposed rule (e.g., 
Sec. 63.21) should be revised to refer to ``* * * decontamination or 
decontamination and dismantlement * * *'' to avoid confusion about the 
need for decontamination.
    Comment. EPA suggested that the reference to decontamination and 
dismantlement in the proposed rule needed clarification because the 
current language implies that facilities that needed dismantlement did 
not need to be decontaminated.
    Response. The Commission agrees with this comment and has revised 
the proposed rule as suggested.
    Issue 10: Should there be additional requirements for the content 
of the application?
    Comment. One commenter recommended that the contents of the license 
application at Sec. 63.21(c)(1)(iv) should also include information on 
the hydrology, geology, and climate at and near the chosen location for 
the critical group.
    Response. In general, the Commission agrees with this comment to 
the extent that the Commission anticipates that it will need such 
information because it has a bearing on understanding the lifestyles 
and habits of the RMEI. However, in the Commission's view, the type of 
information suggested by the commenter is already included in the 
regulations at Sec. 63.21(c)(1). Nonetheless, the Commission expects 
that this subject will be addressed in the YMRP, which describes the 
required contents and methods for the NRC staff review of any potential 
DOE construction authorization application, as well as DOE's compliance 
demonstration with the rule. At the appropriate time, the YMRP will be 
shared with interested stakeholders and published for public comment. 
Based on the public comments received, the staff will determine if 
additional revisions to the YMRP or regulations are necessary (e.g., 
additional information to be included in the content of the application 
and a requirement for DOE to address all the issues in the YMRP).
    Issue 11: Does the requirement for collecting information during 
construction (Sec. 63.72) take precedence over preservation of the 
design integrity?
    Comment. It should be recognized that there is the possibility that 
the collection of certain types of data could

[[Page 55773]]

have a negative effect on the waste isolation capabilities of the site. 
The proposed requirements found in Sec. 63.72 should be modified to 
recognize that data should be collected only when it is determined that 
the activities will have no adverse effect on the long-term performance 
of the repository.
    Response. The Commission shares the commenter's concern that the 
collection of data could (potentially) have an adverse effect on the 
long-term performance of the repository. In this regard, it should be 
noted that the Commission is not in favor of any particular data 
collection techniques nor would it encourage data collection that could 
potentially affect the long-term performance of the repository or the 
effectiveness of its barriers be they natural or engineered. 
Nonetheless, during repository construction, DOE will need to collect 
data to confirm certain design (and performance) parameters as well as 
to identify previously undetected geologic conditions so as to have 
confidence that the repository will function as intended. To ensure 
that these activities have no effect on long-term repository 
performance, consistent with section 113(b)(1)(A)(ii) of the NWPAA, DOE 
will need to describe its data collection plans during construction in 
the manner described in Sec. 63.72 so that their effect, if any, on 
containment and waste isolation can be independently evaluated by the 
NRC staff.
    Issue 12: The reference to Sec. 63.51(a)(2) (postclosure monitoring 
program) in Secs. 63.71(b) (records and reports) and 63.72(a) 
(construction records) should be changed to refer to Sec. 63.51(a)(3) 
(measures to regulate or prevent activities that could impair 
repository long-term performance).
    Comment. Section 63.51(a)(3) refers to the description of the 
program for the postclosure monitoring program for the repository and 
not to record retention. The proposed requirements in Secs. 63.71(b) 
and 63.72(a) also bear some relation to postclosure design, and this 
should be clarified in the rule.
    Response. The commenter is correct, and the final rule contains the 
correct reference.
    Issue 13: It is not clear how liquid HLW fits into DOE's disposal 
scenario.
    Comment. From the definition of HLW found at Sec. 63.2, it would 
appear that liquid HLW could also be disposed of at Yucca Mountain.
    Response. Because of processing in the nuclear fuel cycle, some HLW 
can occur in the liquid (aqueous) state. However, this waste type is 
not expected to be disposed of at Yucca Mountain. Rather, liquid HLW 
will be vitrified--mixed with molten glass and solidified--to reduce 
the actual volume of waste and make it easier to handle. The definition 
of HLW found at Sec. 63.2 was intended only to provide a technically 
correct definition of HLW in its various states. To provide further 
clarification, the definition has been revised to better reflect the 
language in the Nuclear Waste Policy Act of 1982 and final 40 CFR part 
197, and continues to include the reference to irradiated reactor fuel 
consistent with the definition in the proposed rule.
    Issue 14: Should climatological data be included for the update of 
the application and EIS?
    Comment. EPA suggested that climatological data should be included 
in the types of data to be updated in the application and EIS 
[Sec. 63.24(b)(1)].
    Response. The list of information to be updated at Sec. 63.24(b)(1) 
includes meteorological data. Meteorological data are used as a general 
term indicating weather related information that would include 
information necessary to make inferences regarding climate. The 
addition of the word climatological is not needed; therefore, the 
language in proposed part 63 will be retained in final part 63.

6  Beyond the Scope of This Rulemaking

    The following comments addressed issues that are beyond the scope 
of this rulemaking. Many of the comments in this category were directed 
at the hearing process, transportation, the selection of Yucca Mountain 
as a potential site for a geologic repository, or objected to deep 
geologic disposal as a method of managing HLW. Part 63 does not affect 
these issues because they already have been determined by legislation, 
are pertinent to other regulations or rulemakings but not to part 63, 
or because the provisions of part 63 are limited to specific regulatory 
areas while these issues are much broader.

6.1  Hearing Process

    Issue: Will the Commission amend the hearing process for repository 
licensing to provide for informal, legislative-style hearings?
    Comment. Some commenters, including EPA, urged NRC to change its 
hearing process to provide for informal, legislative-style hearings for 
repository licensing. One commenter suggested that the Commission 
itself be the hearing board. NEI expressed the view that a legislative-
style hearing process is more conducive to effective scientific inquiry 
than formal adjudicatory procedures. NRC's decision on whether to adopt 
an informal process for repository licensing, in NEI's view, should not 
be tied to the generic question whether to revise the overall hearing 
process but, instead, should be the subject of a separate rulemaking. 
However, another commenter strongly opposed any suggestion to depart 
from formal trial-type adjudicatory and evidentiary hearing rules in 10 
CFR part 2 for this potentially complex and first-of-a-kind licensing 
proceeding.
    Response. In the proposed rule, the Commission told commenters that 
it had a broad study of the NRC hearing process underway, including the 
process that would be used for repository licensing. The Commission 
stated that it was inclined to provide for informal hearings for both 
construction authorization and licensing to receive and possess waste. 
If the Commission were to conclude that changes to the hearing process 
are warranted, the Commission stated that it would propose them for 
adoption in a separate notice and comment rulemaking. For that reason, 
the Commission did not seek comments on potential changes to the 
hearing process in this rulemaking. Subsequently, the Commission 
finished its study of the NRC hearing process and directed the staff to 
prepare a proposed rule to provide changes to that process. The 
proposed rule was published on April 16, 2001 (66 FR 19610) and the 
comment period closes on September 14, 2001 (extension of comment 
period, 66 FR 27045; May 16, 2001). In this recent notice, the 
Commission proposes to use formal hearing procedures in proceedings for 
the initial authorization to construct a geologic repository operations 
area and proceedings for initial authorization to receive and possess 
high-level waste at the repository. However, amendments to the 
construction authorization and to the authorization to receive and 
possess high-level waste may be conducted under informal hearing 
procedures. See proposed Sec. 2.310(e). The Commission will make its 
final determinations on these issues in a final rule after it has 
considered all public comments received in this separate rulemaking.

6.2  Transportation

    Issue 1: What regulations or controls will be used to ensure 
nuclear waste is transported safely including operations at an 
intermodal transfer facility?
    Comment. Commenters raised concern that the risks for transporting 
nuclear waste were not being addressed in proposed part 63. Many 
commenters interpreted the absence of transportation criteria in 
proposed part 63 as an indication that NRC has deemphasized

[[Page 55774]]

transportation issues. One commenter raised concern over the 
possibility of terrorism and theft of spent fuel shipments.
    Response. Nuclear waste transportation safety is not specifically 
addressed by the proposed part 63 because it is beyond the scope of 
this rulemaking. Issues related to terrorism or theft of spent fuel 
shipments during transport are also beyond the scope of this part 63 
rulemaking. Nothing in this rule changes the existing regulatory regime 
governing the transportation of spent nuclear fuel and high-level 
radioactive waste. In light of the terrorist attacks of September 11, 
2001, the Commission has directed the staff to conduct a comprehensive 
reevaluation of NRC physical security requirements. If this effort 
indicates that NRC's regulations or requirements warrant revision, such 
changes would occur through a public rulemaking or other appropriate 
methods.
    Section 180 of the NWPA requires DOE to use packages that have been 
certified by NRC for transportation of spent nuclear fuel and HLW. The 
NRC regulations in 10 CFR part 71 specify the standards for 
certification. These standards provide that a package must prevent the 
loss or dispersion of radioactive contents, provide adequate shielding 
and heat dissipation, and prevent nuclear criticality under both normal 
and accident conditions of transportation.
    Section 180 of the NWPA also requires that DOE abide by NRC 
regulations regarding advance notification of State and local 
governments prior to transportation of spent nuclear fuel or high-level 
radioactive waste. These advance notification requirements are set 
forth in 10 CFR 73.37. The NWPA also requires DOE to provide funds and 
technical assistance for training of local public safety officials 
(e.g., emergency responders) along the routes.
    In Volume II of the Draft Environmental Impact Statement for a 
Geologic Repository for the Disposal of Spent Nuclear Fuel and High 
Level Radioactive Waste at Yucca Mountain, Nye County, Nevada, dated 
July 1999 (DEIS) (at J-23), DOE states that its proposed procedures for 
implementing Section 180 of the NWPA provide that routing for shipments 
to Yucca Mountain would comply with applicable regulations of the U.S. 
Department of Transportation (DOT) in effect at the time of such 
shipments. DOT regulations on route approval for transporting 
radioactive material by highway and State or Tribal designation of 
preferred routing [as an alternative to Interstate System highways] are 
contained in 49 CFR 397.101, 397.103, and 397.201.
    A DOT-NRC Memorandum of Understanding (44 FR 38690; July 2, 1979) 
specifies that, in general, the DOT is responsible for regulating 
safety in transportation of all hazardous materials, including 
radioactive material. The NRC is responsible for regulating safety in 
receipt, possession, use, and transfer of radioactive materials. The 
NRC also reviews and approves package designs for transporting fissile 
material and other radioactive material in quantities exceeding Type A 
limits. Facilities which temporarily handle and store radioactive 
material during and incidental to their transport (i.e., movement), 
such as operations at an intermodal transfer facility, are subject to 
DOT requirements.
    Issue 2: How will transportation routes be selected and will local 
governments and communities be informed and consulted about the routes?
    Comment. Commenters raised a number of questions regarding the 
selection of transportation routes for nuclear waste, such as: (1) Will 
DOE analyze the impacts of transportation routes; (2) Can rural roads 
be used to safely transport large nuclear waste shipments; (3) Will 
transportation route selection be addressed in DOE's license 
application; (4) Will local governments and communities be able to 
participate in route selection; and (5) Does NRC require DOE 
contractors to be responsible for transporting waste or are third-party 
contractors responsible for transporting waste.
    Response. The routing requirements and practices largely depend 
upon whether a particular shipment is made by highway or railway. DOE 
is evaluating its options regarding the mix of road and rail shipments 
to the potential repository and will decide the appropriate level of 
analysis needed for transportation routes.
    As noted, DOE has stated that routing of shipments of spent nuclear 
fuel and high-level waste will comply with applicable DOT regulations 
(DEIS, Vol. II, at J-23). The DEIS (Vol. I and Vol. II, Appendix J) 
also contains a discussion of the impacts associated with shipments to 
the proposed repository. The DOT regulations (49 CFR part 397) provide 
that shipments are to be on preferred routes (Interstate System 
highways and city bypasses) or State-or Tribal-designated preferred 
routes (i.e., alternate routes). These routing requirements were 
developed by the DOT considering the risks of transportation. Further, 
DOT has published guidelines (DOT/RSPA/HMS/92-02) for State or Tribal 
agencies to use in performing route analyses to ensure that the overall 
risk of the shipments to the public is considered in designating 
preferred routes. The degree of local participation in the State or 
Tribal routing agency's process may vary from State to State or from 
Tribe to Tribe.
    NRC licensees, contractors of NRC licensees, DOE, and DOE 
contractors who are transporting spent fuel by highway must abide by 
the DOT's routing rules when they transport spent fuel by highway. 
There are no Federal regulations for selecting railway routing. Once a 
highway or railway route is selected, the route is reviewed by the NRC 
for physical protection purposes. NRC annually publishes a report, 
``Public Information Circular for Shipments of Irradiated Reactor 
Fuel'' (NUREG-0725, Rev. 13, 1998), that describes the routes taken by 
commercial spent fuel shipments. For physical protection reasons, 
certain information on shipments is protected from general release 
until after the shipment (or series of shipments) is completed.
    Issue 3: What criteria will be used to ensure the shipping cask can 
survive a variety of challenges during transportation?
    Comment. Commenters inquired into how shipping casks were designed 
and who was responsible for manufacturing the casks. Additionally, one 
commenter asked whether the shipping cask design and testing consider 
specific accident scenarios, including sabotage.
    Response. An application for a cask design is submitted to NRC by 
the cask vendor, and an approval certificate must be issued by NRC 
before a cask can be used to transport spent fuel. Typically, private 
firms manufacture a cask under contract to the cask's vendor. NRC 
requires that casks be designed, fabricated, used, and maintained under 
an NRC-approved QA plan. Activities under these plans are subject to 
NRC's inspection and enforcement programs. Safety standards, design 
criteria, and design test requirements for spent fuel casks are set 
forth in NRC regulations at 10 CFR part 71. Casks must be designed to 
withstand a series of impact, puncture, and fire environments, thereby 
providing reasonable assurance that packages will withstand serious 
transportation accidents. NRC regulations require that casks protect 
against the loss or dispersion of radioactive contents, provide 
adequate shielding and heat dissipation, and prevent nuclear 
criticality, under both incident-free and accident conditions of

[[Page 55775]]

transportation. NRC conducts an independent design review prior to 
issuing a cask certificate.
    In the 1980's, NRC sponsored experiments and studies of the effects 
of sabotage on casks that meet NRC's safety standards. In addition, DOE 
has sponsored similar studies, most recently in 1999. The estimated 
performance of spent fuel casks during historically severe, actual 
accidents (viz., these severe accidents did not actually involve 
radioactive materials) was investigated as part of the NRC-sponsored 
study (e.g., Fischer, L.E., et. al., ``Shipping Container Response to 
Severe Highway and Railway Accident Conditions,'' NUREG/CR-4829, 1987). 
NRC's studies show that risks are low, from both incident-free 
shipments of radioactive material and possible accidents during 
transport. Therefore, the Commission has found that approved cask 
designs provide an adequate level of protection of public health and 
safety.
    Issue 4: Will dose estimates be calculated for exposures from 
transportation and operations at an intermodal transfer facility?
    Comment. A commenter asked that dose estimates be calculated for 
exposures from transportation and operations at an intermodal transfer 
facility.
    Response. NRC has estimated the radiation doses to the population 
as a result of transportation of radioactive material. These estimates 
are performed as part of environmental impact studies such as NUREG-
0170 (1977), ``Final Environmental Statement on the Transportation of 
Radioactive Material by Air and Other Modes.''
    The specific operations that would occur at an intermodal transfer 
facility related to the repository have not been identified. 
Consequently, NRC is not aware of radiation dose estimates that have 
been performed for that facility. Furthermore, the NRC notes that DOT 
requirements govern radiation safety for facilities which temporarily 
handle and store radioactive material during and incidental to their 
transport (i.e., movement), such as operations at an intermodal 
transfer facility.

6.3  Other Comments

    Issue 1: Should nuclear waste be sent somewhere else/out of Nevada?
    Comment. A number of commenters believed that nuclear waste should 
be sent somewhere else (other than Yucca Mountain), or out of Nevada. 
Yucca Mountain was viewed as unsafe. Commenters did not want a nuclear 
waste repository constructed there and strongly objected to disposal of 
radioactive waste there. An opposing view was expressed by other 
commenters who stated that Yucca Mountain was the best place for 
disposal of radioactive waste. One commenter just wanted the waste kept 
safe.
    Response. The NWPAA authorizes characterization of only Yucca 
Mountain, Nevada, as a potential repository site. Part 63 does not 
select Yucca Mountain as a site for a potential repository. Part 63 is 
being promulgated to provide reasonable assurance that, if a repository 
is built and operated at Yucca Mountain, public health and safety will 
be protected.
    Issue 2: Is there a better solution for managing nuclear waste than 
geologic disposal?
    Comment. There were a number of comments focused on whether an 
alternative should be used for management of radioactive waste. Some 
commenters stated that the use of onsite storage (i.e., at nuclear 
reactors) of nuclear waste should be pursued. This would avoid 
transportation risks and be a suitable interim method of managing 
nuclear waste until a safe long-term disposal method was found. 
However, one commenter stated that it was appropriate and safe to place 
the waste in one location. Newly emerging technologies, such as 
transmutation, were cited by some commenters as methods that could 
reduce the hazard of the waste. A commenter noted that the materials 
making up the waste could be used in the future; there were numerous 
applications. Comments were received opposing underground disposal of 
spent fuel rods as unsafe, and not the best answer for disposal, and 
that only cooled spent fuel rods, but no plutonium, should be stored at 
Yucca Mountain or the NTS.
    Response. The decision about how to manage HLW and spent fuel does 
not result from part 63. Deep geologic disposal of HLW was authorized 
by the NWPA. The NWPAA and the EnPA continue the U.S. government policy 
of disposal of HLW in a geologic repository. Nothing in part 63 changes 
this method of managing HLW authorized by existing law. The regulations 
in part 63 are designed to provide reasonable assurance of protection 
of public health and safety from any radioactive material disposed of, 
including surplus weapons plutonium.
    Issue 3: Who should manage the Yucca Mountain project?
    Comment. Commenters suggested that the University of Nevada at Las 
Vegas should manage the Yucca Mountain project.
    Response. The NWPA gives DOE the responsibility for management of 
the Yucca Mountain project. DOE must address how to carry out its 
responsibility for management of the Yucca Mountain project.
    Issue 4: Should nuclear power be used?
    Comment. A commenter opposed the use of nuclear power as wasteful 
and the source of dangerous long-lived radioactive products. Another 
commenter said that sources of energy other than fission should be 
investigated.
    Response. Part 63 establishes requirements for disposal of HLW at a 
potential repository at Yucca Mountain. It does not encourage or 
restrict the use of nuclear power. The NRC is establishing part 63 in 
accordance with its statutory responsibilities under the Atomic Energy 
Act (AEA), the NWPAA, and the EnPA.
    Issue 5: How much money has been spent on Yucca Mountain?
    Comment. A commenter wanted to know how much money had been spent 
on the Yucca Mountain project.
    Response. The DOE publishes reports that give details of its budget 
and spending on the Yucca Mountain project. Expenditures are the 
subject of appropriations by Congress and oversight by both Congress 
and the General Accounting Office. In May 2001, DOE published its most 
recent cost estimates [see ``Analysis of the Total System Lifecycle 
Costs of the Civilian Radioactive Waste Management Program,'' DOE/RW-
0533, May 2001; available on DOE's Web page at http://www.rw.doe.gov].
    Issue 6: What happens if the Yucca Mountain project is developed 
and Congress cuts the budget for it? Or appoints a weaker agency to 
oversee the project?
    Comment. A commenter noted that Congress had cut DOE's budget for 
Yucca Mountain in past years. What will NRC do, especially regarding 
monitoring, if construction of the project is underway, and a budget 
cut occurs?
    Response. Responsibility for the Yucca Mountain project rests with 
DOE. Changes in budget levels for the Yucca Mountain project would have 
to be addressed by DOE in its planning for the project. If the 
Commission believes that it does not have sufficient funds to carry out 
its mission to protect public health and safety, it would ask Congress 
for additional funding.
    Issue 7: Will the NRC staff seek input from local governments to 
assist it in providing comments to the DOE on the DEIS for Yucca 
Mountain?

[[Page 55776]]

    Comment. One commenter asked the NRC to seek input from local 
governments to assist the NRC in providing comments on the DOE's DEIS.
    Response. The NRC is expected, under the NWPA, to comment on the 
DEIS during the DEIS public comment period. The NRC provided comments 
for DOE to consider as part of the DEIS public comment process. In 
preparing these comments, the NRC staff observed DOE's DEIS public 
meetings to better understand what DEIS issues were of concern to the 
public. In addition, the NRC staff conducted its own meetings with AULG 
officials and conducted a public meeting in Caliente (Nevada) to 
discuss the NRC role with respect to the EIS, as it was formulating its 
comments. For its part, the Commission invited AULGs, stakeholders, and 
other interested parties to express their views on the DEIS during a 
public meeting on January 21, 2000. The Commission has considered these 
views before forwarding its comments to DOE.
    Issue 8: Does the public have enough time to prepare comments on 
DOE's DEIS for Yucca Mountain and attend NRC meetings on part 63?
    Comment. The NRC staff was asked at several public meetings to 
avoid scheduling future public workshops and meetings on part 63 during 
the DEIS public comment period.
    Response. The Commission is sensitive to the issue being raised 
here and notes that the NRC is making every effort practical to 
schedule its public workshops and meetings in such a way so as to 
afford the public opportunity to participate in other agencies' 
activities. Accordingly, the Commission held only one meeting on part 
63 during the public comment period on the DEIS.
    Issue 9: What about the possibility that a waste repository at 
Yucca Mountain would be a target in the event of a nuclear war?
    Comment. A commenter stated that the Air Force base and Hoover dam 
would be likely targets in the event of war. If a repository were 
developed at Yucca Mountain, that would also be a target.
    Response. Consideration of the effects of wars and military actions 
is beyond the scope of NRC's responsibility. The NRC has not taken into 
account the effects of war in developing part 63.
    Issue 10: Decisions regarding the licensing of a potential geologic 
repository at Yucca Mountain should be left to the voters to decide.
    Comment. A commenter stated that important decisions, such as the 
potential geologic repository, should be placed on a nationwide ballot 
for the voters to decide.
    Response. The NWPA and the EnPA establish the framework for 
licensing a potential geologic repository at Yucca Mountain. This 
legislation gives the NRC the responsibility for making a licensing 
decision on such a potential repository. Under this framework for 
licensing, there are opportunities for public input in the licensing 
process. The requirements promulgated here as part 63 do not make any 
change in public input opportunities already established.
    Issue 11: How much radiation is being released from nuclear 
facilities?
    Comment. Commenters wanted to know how much radiation was being 
released from nuclear facilities around the U.S. and what is being done 
to control those releases.
    Response. The NRC's Annual Report--Reactors, NUREG-1272, Vol. 11, 
No.1, November 1998, gives annual exposures to the average person in 
the U.S. of less than 1 mrem (0.01 mSv) TEDE from the entire nuclear 
fuel cycle, including operation of reactors. All NRC licensees are 
required to limit radiation exposures from licensed activities in 
accordance with NRC regulations in 10 CFR part 20, 10 CFR part 50, 
Appendix I, and 10 CFR part 72.
    Issue 12: Is radioactive material recycled into consumer products?
    Comment. One commenter was concerned about potential exposure from 
radioactive material that has been recycled into consumer products.
    Response. Part 63 is concerned only with disposal of HLW in a 
potential geologic repository at Yucca Mountain, Nevada. There are no 
provisions in this final rule that affect recycling of radioactive 
material into consumer products.
    NRC is in the preliminary stages of examining its approach for 
controlling solid material. A paper that discusses issues associated 
with alternative courses of action was published in the Federal 
Register on June 30, 1999 (64 FR 35090). This issues paper is also 
available at NRC's web site.
    Issue 13: Does NRC regulate the transportation of nuclear weapons?
    Comment. One commenter inquired as to NRC's role in the 
transportation of nuclear weapons.
    Response. The NRC does not have authority to regulate the 
transportation of nuclear weapons. The NRC's regulations for packaging 
and transportation of radioactive materials, 10 CFR part 71, do not 
apply to transportation of nuclear weapons.

IV. Changes from the Proposed Rule

Subpart A--General Provisions

Section 63.2  Definitions
    Several terms have been deleted and definitions revised either to 
conform with the final EPA standard (40 CFR part 197) or to provide 
needed clarification. The terms annual dose and expected annual dose 
have been replaced by a single definition for TEDE (total effective 
dose equivalent) that provides for the use of organ weighting factors 
for assessing potential doses to members of the public. The term 
critical group has been deleted, and the term reasonably maximally 
exposed individual added and defined. The term design basis event has 
been deleted, and replaced with the terms event sequence and initiating 
event (the term design basis event has been replaced throughout the 
rule with event sequence). The term integrated safety analysis has been 
deleted, and replaced with the term preclosure safety analysis (the 
term integrated safety analysis has been replaced throughout the rule 
with preclosure safety analysis). The definition of performance 
confirmation has been revised to more clearly reflect the intent of the 
general requirements for performance confirmation at Sec. 63.131(a). 
The definition of the engineered barrier system has been revised to 
include engineered components and systems other than the waste package 
(e.g., drip shields). The definition of retrieval has been revised to 
clarify that retrieval means the act of ``permanently'' removing 
radioactive waste. The clarification to the definition of retrieval was 
done to differentiate it from operational activities (e.g., DOE might 
intentionally remove one or several waste packages from its emplacement 
location and re-emplace them either at the same or a different location 
in the underground facility during the operational life of the 
repository as part of testing, demonstration, repair, maintenance or 
performance confirmation) that would not be considered as permanent 
retrieval. The definition for high-level waste has been modified to 
more closely reflect the definition provided in the Nuclear Waste 
Policy Act of 1982 and final 40 CFR part 197. The definition for the 
saturated zone has been revised to more accurately describe the intent 
of the definition. Other definitions have been modified in whole or in 
part to conform with the final 40 CFR part 197, including barriers, 
important to waste isolation, isolation, performance assessment, and 
reference biosphere. The definition for ground water has

[[Page 55777]]

been removed from this section because the definition for the same term 
provided in 40 CFR part 197 has been adopted into the regulations at 
Sec. 63.302.
Section 63.4  Communications and Records
    The section was revised to reflect the current address of the 
Commission.
Section 63.8  Information collection requirements: OMB approval
    This section has been revised according to the current standard 
wording.
Section 63.10  Completeness and Accuracy of Information
    The recipient of notification of information was changed from the 
Administrator of the appropriate Regional Office to the Director of the 
Office of Nuclear Material Safety and Safeguards.

Subpart B--Licenses

Section 63.16  Review of site Characterization Activities
    Section 63.16(d) was clarified to specify that public comments 
would be sought on comments made by the Director of the Office of 
Nuclear Material Safety and Safeguards to DOE after the Director's 
comments had been sent to DOE. Section 63.16(d) essentially adopts 10 
CFR 60.18(i) with the addition of performance assessment as a subject 
area for potential public comments. The Commission explained at the 
time it adopted Sec. 60.18(i) that ``(j)ust as the Commission will 
solicit comments on its comments on DOE's initial S(ite) 
C(haracterization) P(lan), it wants to allow for public comment on any 
Commission comments on DOE's semi-annual reports (or on any other 
comments which the Director makes to DOE on site characterization)'' 
(51 FR 27161; July 30, 1986). Under Sec. 60.18(f), the Director must 
publish in the Federal Register a notice of the availability of 
comments on DOE's Site Characterization Plan for public comment after 
the comments have been sent to DOE. Section 63.16(d) was clarified to 
reflect the Commission's intent that the timing of any public comment 
period remain the same as under Sec. 60.18.
Section 63.21  Content of Application
    Requirements associated with the description of the engineered 
barrier system, quality assurance program, physical protection, design 
criteria, and decontamination of surface facilities have been 
clarified. The requirements in this section have been regrouped in an 
order more consistent with the required analyses. The requirement for 
DOE to provide a comparative evaluation of alternatives to major design 
features has been removed. The level of information necessary to 
support each licensing stage has been clarified by stating the 
application must be as complete as possible in the light of information 
that is reasonably available at the time of docketing. The words 
``principal design criteria'' have been replaced with ``design 
criteria'' to avoid any confusion with the meaning of the word 
``principal;'' this was not intended as a substantive change. The 
design criteria to be described are those that relate to the preclosure 
and postclosure performance objectives. This provides DOE sufficient 
guidance as to which design criteria are to be provided. The reference 
to ``ground water'' at Sec. 63.21(c)(10) was changed to ``water'' to 
maintain the intent of the proposed rule, which included both saturated 
and unsaturated zone water in the definition of ground water, and avoid 
conflict with the new definition for ``ground water'' in subpart L. 
Additional changes have been made to conform to the final 40 CFR part 
197.
Section 63.31  Construction Authorization
    This section was modified to reflect a finding of reasonable 
expectation for demonstration of compliance with the quantitative 
standards now specified in new Subpart L.
Section 63.41  Standards for Issuance of a License
    Clarification has been made regarding decontamination of surface 
facilities.
Section 63.42  Conditions of License
    Section 63.42(d) was modified to eliminate the specific reference 
to the NWPA limit of 70,000 MTU. Although this limit still applies, by 
simply referring to ``* * * NWPA, as amended * * *,'' the need for a 
future rulemaking would be obviated if the legislation ever changes 
this disposal volume restriction.
Section 63.44  Changes, Tests, and Experiments
    This section has been extensively revised in accordance with NRC-
wide programmatic changes in this area.
Section 63.51  License Amendment for Permanent Closure
    This section has been revised to specifically require that 
performance confirmation data pertinent to compliance with Sec. 63.113 
be included in the update of the performance assessment in the 
application for a license amendment for permanent closure.
Section 63.52  Termination of License
    Clarification has been made regarding decontamination of surface 
facilities.

Subpart C--Participation by State Government, Affected Units of Local 
Government, and Affected Indian Tribes

Section 63.61  Provision for Information
    This section has been changed to include the affected units of 
local government.
Section 63.62  Site Review
    This section has been changed to include the affected units of 
local government.
Section 63.63  Participation in License Reviews
    This section has been changed to correct the reference to ``Subpart 
G'' to read ``Subpart J,'' and the reference to local governments has 
been clarified by changing it to ``affected units of local 
government.'' The final sentence in proposed Sec. 63.63(a) has been 
deleted.
Section 63.65  Representation
    This section has been changed to include the affected units of 
local government.

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

Section 63.71  Records and Reports
    The record retention requirements referenced at Sec. 63.71(b) were 
incorrect in the proposed rule and have been modified to refer 
correctly to Sec. 63.51(a)(3).
Section 63.72  Construction Records
    The record retention requirements referenced at Sec. 63.72(a) were 
incorrect in the proposed rule and have been modified to refer 
correctly to Sec. 63.51(a)(3). Additionally, the design specifications 
and ``as built'' drawings have been added to the list of required 
records.
Section 63.73  Reports of Deficiencies
    The phrase ``(b)e a substantial safety hazard,'' found at 
Sec. 63.73(a)(1), was replaced with the phrase ``(a)dversely affect 
safety at any future time,'' to be consistent with terminology used at 
Sec. 63.32(b)(3) and to avoid confusion with reporting requirements 
under 10 CFR part 21, which includes a very precise definition for what 
constitutes a ``substantial safety hazard.'' Specific requirements 
regarding DOE's implementation of a program for

[[Page 55778]]

evaluating and reporting deficiencies have been included to clarify the 
reporting requirements.

Subpart E--Technical Criteria

Section 63.101  Purpose and nature of findings
    This section has been revised to address how the Commission intends 
to implement a finding of reasonable expectation. The discussion of 
postclosure performance objectives has been revised to conform with the 
public health and environmental radiation standards for geologic 
disposal now specified in Subpart L, which are referenced in 
Sec. 63.113.
Section 63.102  Concepts
    This section has been changed to clarify NRC's expectations for the 
demonstration of compliance with the requirements for multiple 
barriers, performance confirmation, and preclosure safety analysis. The 
discussion of multiple barriers has been modified to clarify the intent 
of the multiple barrier requirement. The discussion of preclosure 
safety analysis has been revised to clarify requirements for the dose 
calculations due to the event sequences and the selection of specific 
event sequences to be included in the analysis. The discussion of 
performance confirmation has been revised to more clearly reflect the 
intent of the general requirements for performance confirmation at 
Sec. 63.131(a). Additional changes have been made to conform with the 
final 40 CFR part 197, including among others the discussion of the 
reference biosphere, reasonably maximally exposed individual, and human 
intrusion; and addition of a discussion on ground-water protection.
Section 63.111  Performance Objectives for the Geologic Repository 
Operations Area Through Permanent Closure
    The performance objectives at Sec. 63.111(b)(1) and (2) have been 
changed to clarify that (1) the doses from consequence analyses for 
Category 1 event sequences are to be aggregated to a single estimate 
and (2) the dose from the consequence analysis for each Category 2 
event sequence is to be estimated for that specific event sequence 
only. Section 63.111(a)(2) has been modified to conform with the 
individual protection standard now specified in subpart K.
Section 63.112  Requirements for Preclosure Safety Analysis of the 
Geologic Repository Operations Area
    This section has been revised to clarify that the objective of the 
analysis is to evaluate event sequences; as such, the phrase 
``accidents that would result in unacceptable consequences'' has been 
replaced with ``event sequences.'' The consideration of criticality has 
been clarified by requiring analysis of the means to prevent and 
control criticality. The words ``principal design criteria'' have been 
replaced with ``design criteria'' to be consistent with the changes 
made at Sec. 63.21 (as noted in the discussion under Sec. 63.21, this 
change was not intended as a substantive change).
Section 63.113  Performance Objectives for the Geologic Repository 
After Permanent Closure
    This section has been modified to conform with the public health 
and environmental radiation standards for geologic disposal now 
specified in subpart L.
Section 63.114  Requirements for Performance Assessment
    The reference to features, events, and processes in this section 
has been changed by removing the words ``of the geologic setting.'' In 
addition, the requirements for multiple barriers have been moved to the 
revised Sec. 63.115.
Section 63.115  Required Characteristics of the Reference Biosphere and 
Critical Group
    Requirements related to characteristics of the reference biosphere 
and critical group have been deleted from this section in light of the 
definitions and concepts necessary to estimate dose to the reasonably 
maximally exposed individual, now specified in subpart L. This section 
now contains the requirements related to multiple barriers formerly at 
Sec. 63.114. This section is now titled ``Requirements for multiple 
barriers'.
Section 63.121  Requirements for Ownership and Control of Interests in 
Land
    This section has been revised to clarify the extent and manner of 
control over lands that DOE must exercise during the preclosure period.

Subpart F--Performance Confirmation Program

Section 63.131  General Requirements
    This section has been revised to replace the word ``geologic'' with 
``natural'' at Sec. 63.131(a) to be consistent with terms used in the 
definition of important to isolation.
Section 63.132  Confirmation of Geotechnical and Design Parameters
    This section has been revised to require DOE to identify parameters 
and interactions to be measured or observed rather than specifically 
prescribing such parameters and interactions.
Section 63.133  Design Testing
    This section has been revised to clarify testing requirements such 
that testing is not limited to in situ testing only; to require 
specific testing of the effectiveness of backfill placement and 
compaction only if backfill is included in the repository design; to 
require ``tests'', rather than ``test sections,'' so as to be more 
general; and to generally reference ``engineered systems and 
components,'' with examples, so as not to limit tests to specific 
features that may or may not be included in the final design of the 
repository. The reference to ``ground water'' was changed to 
``unsaturated zone and saturated zone water'' to maintain the intent of 
the proposed rule, which included both saturated and unsaturated zone 
water in the definition of ground water, and avoid conflict with the 
new definition for ``ground water'' in subpart L.

Subpart G--Quality Assurance

Section 63.141  Scope
    This section was revised to clarify the extent of the geologic 
repository system by adding ``structures'' and ``systems'' and deleting 
the word ``subsystems.''
Section 63.142  Quality Assurance Criteria
    This section has been revised to include previously referenced 
quality assurance requirements. Provisions of Appendix B to 10 CFR part 
50, as applicable, have been brought into this section rather than 
merely referencing appendix B in the rule. The introduction of the 
language from Appendix B into the final part 63 has not changed any 
requirements in the proposed part 63. This approach specifies the 
quality assurance requirements and removes any ambiguity regarding 
which portions of Appendix B are applicable to Yucca Mountain.
Section 63.143  Implementation
    This section has been revised to reference the criteria at 
Sec. 63.142 rather than the criteria in Appendix B of 10 CFR part 50, 
as applicable.
Section 63.144  Quality Assurance Program Change
    This section has been added to provide requirements for how changes 
to the quality assurance program description are to be processed.

[[Page 55779]]

Subpart K--Preclosure Public Health and Environmental Standards

Section 63.201  Purpose and Scope
    New section that states the requirements in this subpart apply to 
the storage of radioactive material in the Yucca Mountain repository 
and on the Yucca Mountain site.
Section 63.202  Definitions for Subpart K
    New section adopted from the final 40 CFR part 197 that contains 
definitions of terms as used in subpart K.
Section 63.203  Implementation of Subpart K
    New section adopted from the final 40 CFR part 197 that states DOE 
must demonstrate that normal repository operations will meet the 
requirements of this subpart.
Section 63.204  Preclosure Standard
    New section adopted from the final 40 CFR part 197 that establishes 
a 0.15 mSv (15 mrem) dose limit during the preclosure period.

Subpart L--Postclosure Public Health and Environmental Standards

Section 63.301  Purpose and Scope
    New section that states the requirements in this subpart apply to 
the disposal of radioactive material in the Yucca Mountain repository.
Section 63.302 Definitions for Subpart L
    New section adopted from the final 40 CFR part 197 that contains 
definitions of terms as used in subparts L and K.
Section 63.303  Implementation of Subpart L
    New section adopted from the final 40 CFR part 197 that states DOE 
must demonstrate there is a reasonable expectation that the projected 
performance of any geologic repository at Yucca Mountain will meet the 
requirements of this subpart for 10,000 years after disposal.
Section 63.304  Reasonable Expectation
    New section adopted from the final 40 CFR part 197 that defines 
what is meant by the reasonable expectation concept used in relation to 
projecting the long-term performance of any geologic repository at 
Yucca Mountain.
Section 63.305  Required Characteristics of the Reference Biosphere
    New section adopted from the final 40 CFR part 197 that describes 
the characteristics of the reference biosphere DOE is to assume for the 
purpose of projecting the long-term performance of the geologic 
repository.

Postclosure Individual Protection Standard

Section 63.311  Individual Protection Standard After Permanent Closure
    New section adopted from the final 40 CFR part 197 that establishes 
an annual, all pathway, individual protection standard of 0.15 mSv (15 
mrem) for the reasonably maximally exposed individual from potential 
releases of radioactivity from any geologic repository at the Yucca 
Mountain site for 10,000 years following disposal.
Section 63.312  Required Characteristics of the Reasonably Maximally 
Exposed Individual
    New section adopted from the final 40 CFR part 197 that defines the 
required characteristics of the reasonably maximally exposed individual 
to be used by DOE in the dose calculations necessary to assess the 
long-term performance of any geologic repository at the Yucca Mountain 
site.

Human Intrusion Standard

Section 63.321  Individual Protection Standard for Human Intrusion
    New section adopted from the final 40 CFR part 197 that describes 
the stylized human intrusion calculation to be used by DOE to evaluate 
the resilience of any geologic repository at the Yucca Mountain site. 
Establishes an annual, all pathway, individual protection standard of 
0.15 mSv (15 mrem) for the reasonably maximally exposed individual, 
from potential releases of radioactivity from the geologic repository 
for 10,000 years after disposal, as a result of the stylized human 
intrusion.
Section 63.322  Human Intrusion Scenario
    New section adopted from the final 40 CFR part 197 that describes 
the assumptions related to a stylized human intrusion scenario DOE will 
use to estimate the dose to any reasonably maximally exposed individual 
from a human intrusion. Additionally, NRC has clarified that the human 
intrusion scenario is to include only those radionuclides transported 
to the saturated zone by water (e.g., water enters the waste package, 
releases radionuclides, and transports radionuclides by way of the 
borehole to the saturated zone); and not consider particulate waste 
material falling into the borehole.

Ground-Water Protection Standards

Section 63.331  Separate Standards for Protection of Ground Water
    New section adopted from the final 40 CFR part 197 that establishes 
limits on the level of radioactivity that would be acceptable in a 
representative volume of ground water 10,000 years following repository 
closure.
Section 63.332  Representative Volume
    New section adopted from the final 40 CFR part 197 that describes 
the assumptions DOE will use in the calculation to estimate the level 
of radioactivity in a representative volume of ground water, at a 
specified point, down-gradient from any geologic repository at Yucca 
Mountain.

Additional Provisions

Section 63.341  Projections of Peak Dose
    New section adopted from the final 40 CFR part 197 that requires 
DOE to estimate peak dose and include the results in its Environmental 
Impact Statement. However, there is no standard that must be met with 
respect to these peak dose calculations, and there is no finding that 
the NRC must make with respect to these peak dose calculations, nor may 
they be the subject of litigation in any NRC licensing proceedings for 
a repository at Yucca Mountain.
Section 63.342  Limits on Performance Assessments
    New section adopted from the final 40 CFR part 197 that describes 
how DOE will determine which features, events, and processes need to be 
considered in the dose assessments described in subpart L.
Section 63.343  Severability of Individual Protection and Ground-Water 
Protection Standards
    New section adopted from the final 40 CFR part 197 that indicates 
the individual protection and ground-water protection standards are 
wholly severable.

Parts 2, 19, 20, 51, 70, 72, 73, and 75

    The following changes are being made to other parts to add 
references to part 63 where appropriate. These changes are needed to 
reflect changes in NRC regulations that have occurred since development 
of the proposed rule and to correct omissions.
Section 2.714  Interventions
    A reference to part 63 is added in the section on interventions in 
any hearing on a license application for a repository.

[[Page 55780]]

Section 2.1013  Use of the electronic docket during the proceeding
    A reference to part 63 is added in the section on use of the 
electronic docket (Licensing Support Network) for a license application 
for a repository.
Section 2.1014  Intervention
    A reference to part 63 is added in the section on procedures for 
intervention and for filing an amendment to a contention.
Section 2.1021  First Prehearing Conference
    A reference to part 63 is added in the section on procedures for 
conducting the first prehearing conference.
Section 2.1023  Immediate Effectiveness
    A reference to part 63 is added in the section containing criteria 
for immediate effectiveness of a decision on issuance or amendment of a 
construction authorization for a repository.
Section 19.20  Employee Protection
    A reference to part 63 is added in the section on employee 
protection to make employee protection provisions applicable to 
employees engaged in protected activities under part 63.
Section 20.1003  Definitions
    A reference to part 63 is added to the definition of ``License'' in 
the definitions section.
Section 20.1401  General Provisions and Scope
    A reference to part 63 is added to the section on general 
provisions and scope of radiological criteria for license termination 
to make these provisions applicable to decommissioning facilities 
licensed under part 63.
Section 20.2001  General Requirements
    A reference to part 63 is added to the section on general 
requirements for waste disposal.
Section 20.2206  Reports of Individual Monitoring
    A reference to part 63 is added to the section on reports of 
individual monitoring to make requirements for individual monitoring 
applicable to a part 63 licensee.
Section 51.22  Criterion for Categorical Exclusion; Identification of 
Licensing and Regulatory Actions Eligible for Categorical Exclusion or 
otherwise Not Requiring Environmental Review
    A reference to part 63 is added to the section on categorical 
exclusions to allow for technical requirements and criteria promulgated 
under part 63 to be included along with technical requirements and 
criteria promulgated under part 60 as actions eligible for categorical 
exclusions.
Section 70.17  Specific Exemptions
    A reference to part 63 is added to the section on specific 
exemptions to include DOE activities that are subject to part 63 or 
part 60 to be exempt from the requirements of part 70.
Section 72.44  License Conditions
    A reference to part 63 is added to the section on license 
conditions. Part 72 already contains a provision limiting the quantity 
of spent fuel at the site of a monitored retrievable storage facility 
until a repository authorized under NWPA and part 60 begins operations. 
This change allows for a repository authorized under part 63 as well.
Section 73.1  Purpose and Scope
    A reference to part 63 is added to the section on purpose and 
scope. This makes certain requirements for the establishment and 
maintenance of a physical protection system applicable to a repository 
licensed under part 63 in addition to part 60.
Section 73.51  Requirements for the Physical Protection of Stored Spent 
Nuclear Fuel and High-Level Radioactive Waste
    A reference to part 63 is added to the section on requirements for 
physical protection of spent fuel and HLW. Applicability of these 
requirements is extended to the GROA licensed under part 63.
Section 75.4  Definitions
    A reference to part 63 is added to the definition of 
``Installation'' in the definitions section. This identifies locations 
where possession of more than 1 effective kilogram of nuclear material 
requires certain safeguards requirements.

V. Section-by-Section Analysis of Part 63

Subpart A--General Provisions

    This subpart, except for Sec. 63.2, ``Definitions,'' contains 
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 their use in this part, as appropriate.
Section 63.1  Purpose and Scope
    This section limits the purpose and scope of part 63 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. It also 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: OMB 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.

[[Page 55781]]

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 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 
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 inasmuch as both activities 
have been completed. 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 retained 
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 the 
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 further 
provides that the Director shall invite public comment on any comments 
made by the Director after the Director's comments have been sent to 
DOE. 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 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 
under this section.

[[Page 55782]]

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  Termination of License
    This section requires DOE to apply for an amendment to terminate 
the license following permanent closure of the geologic repository and 
the decontamination or decontamination and dismantlement of surface 
facilities at the Yucca Mountain site.

Subpart C--Participation by State Government, Affected Units of Local 
Government, and Affected Indian Tribes

    This subpart contains provisions that are similar to the State and 
affected Indian Tribe participation provisions of 10 CFR part 60, with 
some wording changes to refer to the State of Nevada, the Yucca 
Mountain site, and to include the AULGs, where appropriate.
Section 63.61  Provision of Information
    This section states that the NRC shall provide to the Governor, the 
Nevada State legislature, AULGs, and any affected Indian Tribe timely 
and complete information regarding determinations made by the 
Commission with respect to the Yucca Mountain site. The NRC shall also 
make this information available to the public and DOE.
Section 63.62  Site Review
    This section states that the NRC shall consult with the State of 
Nevada, AULGs, and affected Indian Tribes regarding site 
characterization activities.
Section 63.63  Participation in License Reviews
    This section sets forth procedures for the State, AULGs, 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, the 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 AULG, 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 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 
the design and construction of the geologic repository operations area, 
if the uncorrected deficiency could adversely affect safety, 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 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 performance 
objectives for the geologic repository operations area through 
permanent closure (preclosure) and the geologic repository after 
permanent closure (postclosure), separate requirements for protection 
of ground water (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 requires 
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. Performance requirements from the 
final 40 CFR part 197, incorporated into subparts K and L, are 
referenced in this subpart.
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 repository 
operations area

[[Page 55783]]

to comply with the exposure limits given in this section, conduct a 
preclosure safety analysis, permit implementation of a performance 
confirmation program, and preserve the option for waste retrieval.
Section 63.112  Requirements for Preclosure Safety Analysis of the 
Geologic Repository Operations Area
    This section specifies the requirements for the preclosure safety 
analysis used to demonstrate compliance with the performance objective 
through permanent closure provided at Sec. 63.111(a)(1) and (a)(2).
Section 63.113  Performance Objectives 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 limits on radiological 
exposures to the reasonably maximally exposed individual, comply with 
limits on releases of radionuclides into the accessible environment, 
comply with the limits on radiological exposures to the reasonably 
maximally exposed individual as a result of a specified human intrusion 
event, and conduct related assessments.
Section 63.114  Requirements for Performance Assessment
    This section specifies the requirements for the performance 
assessment used to demonstrate compliance with the requirements 
specified at Sec. 63.113(b), (c), and (d).
Section 63.115  Requirements for Multiple Barriers
    This section requires DOE to identify and describe the natural 
features of the geologic setting and design features of the engineered 
barrier system that are considered barriers important to waste 
isolation.
Section 63.121  Requirements for Ownership and Control of Interests in 
Land
    This section requires DOE to have permanent control of the geologic 
repository operations area. It states that DOE shall set up controls 
necessary to prevent adverse human actions that could affect the 
repository. Appropriate controls shall be established outside the 
geologic repository operations area. DOE is required to obtain water 
rights needed for the repository.

Subpart F--Performance Confirmation Program

    This subpart contains 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 testing of such 
features as borehole and shaft seals, backfill, drip shields, and the 
thermal interaction effects of waste packages, backfill, rock, and 
ground water.
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 provisions that are similar to the quality 
assurance provisions of 10 CFR part 60. Rather than referencing 
Appendix B to 10 CFR part 50, as was done in 10 CFR part 60, 10 CFR 
part 63 has incorporated quality assurance requirements from Appendix B 
that are specifically applicable to a geologic repository.
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  Quality Assurance Criteria
    This section indicates that the quality assurance program applies 
to all structures, systems, and components important to safety, to 
design and characterization of barriers important to waste isolation, 
and to activities related thereto. This section specifies the 
applicability and criteria for DOE's quality assurance program 
description.
Section 63.143  Implementation
    This section indicates that the quality assurance program is to be 
based on the criteria required by Sec. 63.142.
Section 63.144  Quality Assurance Program Change
    This section specifies when DOE is allowed to make a change to a 
previously accepted quality assurance program without prior NRC 
approval.

Subpart H--Training and Certification of Personnel

    This subpart contains 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 provisions for emergency planning.
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 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.

[[Page 55784]]

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 sections 161b, 161i, or 161o except for the 
sections listed in Sec. 63.172(b).

Subpart K--Preclosure Public Health and Environmental Standards

    This subpart contains provisions that are consistent with the 
public health and environmental standards for storage specified at 40 
CFR part 197.
Section 63.201  Purpose and scope
    This section stipulates that, to the extent that there may be a 
conflict, the requirements in this subpart take precedence over other 
requirements in subparts A through J.
Section 63.202  Definitions for Subpart K
    This section contains definitions of terms as used in this subpart 
and subpart L.
Section 63.203  Implementation of Subpart K
    This section provides a functional overview of this subpart.
Section 63.204  Preclosure Standard
    This section specifies the dose limits that DOE must meet when 
storing waste at a geologic repository.

Subpart L--Postclosure Public Health and Environmental Standards

    This subpart contains provisions that are consistent with the 
public health and environmental standards for disposal specified at 40 
CFR part 197.
Section 63.301  Purpose and Scope
    This section stipulates that, to the extent that there may be a 
conflict, the requirements in this subpart take precedence over other 
requirements in subparts A through J.
Section 63.302  Definitions for Subpart L
    This section contains definitions of terms as used in this subpart.
Section 63.303  Implementation of Subpart L
    This section provides a functional overview of this subpart.
Section 63.304  Reasonable Expectation
    This section defines what is meant by the reasonable expectation 
concept.
Section 63.305  Required Characteristics of the Reference Biosphere
    This section specifies characteristics of the reference biosphere 
to be used by DOE in its performance assessment to demonstrate 
compliance with the requirements specified at Sec. 63.113(b) and (d).

Postclosure Individual Protection Standard

Section 63.311  Individual Protection Standard After Permanent Closure
    This section specifies the dose limit for any geologic repository 
at the Yucca Mountain site.
Section 63.312  Required Characteristics of the Reasonably Maximally 
Exposed Individual
    This section specifies characteristics of the reasonably maximally 
exposed individual to be used by DOE in the performance assessment used 
to demonstrate compliance with the requirements specified at 
Sec. 63.113(b) and (d).

Human Intrusion Standard

Section 63.321  Individual Protection Standard for Human Intrusion
    This section directs DOE to estimate the dose resulting from a 
stylized human intrusion drilling scenario and specifies the dose limit 
that any geologic repository at the Yucca Mountain site must meet as 
the result of any such hypothetical human intrusion.
Section 63.322  Human Intrusion Scenario
    This section specifies the assumptions related to a stylized human 
intrusion scenario DOE will use to estimate the dose to any reasonably 
maximally exposed individual from a human intrusion.

Ground-Water Protection Standards

Section 63.331  Separate Standards for Protection of Ground Water
    This section specifies limits on the levels of radioactivity that 
would be acceptable in a representative volume of ground water found in 
the accessible environment for up to 10,000 years following repository 
closure.
Section 63.332  Representative Volume
    This section specifies the assumptions DOE will use to estimate the 
levels of radioactivity in a representative volume of ground water, at 
a specified point, down-gradient from any geologic repository at the 
Yucca Mountain site for up to 10,000 years following repository 
closure.

Additional Provisions

Section 63.341  Projections of Peak Dose
    This section specifies that DOE will estimate peak dose and include 
the results in its Environmental Impact Statement. However, there is no 
standard that must be met with respect to these peak dose calculations, 
and there is no finding that the NRC must make with respect to these 
peak dose calculations, nor may they be the subject of litigation in 
any NRC licensing proceedings for a repository at Yucca Mountain.
Section 63.342  Limits on Performance Assessments
    This section specifies how DOE will identify which features, 
events, and processes will be considered in the dose assessments 
described in Subpart L.
Section 63.343  Severability of Individual Protection and Ground-Water 
Protection Standards
    This section stipulates that calculations required by Secs. 63.311 
and 63.331 can be performed independently of each other.

VI. Section-by-Section Analysis of Corresponding Changes to Other 
Parts

    Section-by-section analysis of changes to parts 2, 19, 20, 21, 30, 
40, 51, 61, 70, 72, 73, and 75.

10 CFR Part 2

    Section 2.101, Filing of applications, is amended to add a 
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 a 
reference to part 63 in the procedures for notification in this 
section.
    Section 2.104, Notice of hearing, is amended to add a reference to 
part 63 in the procedures for notification of hearings.
    Section 2.105, Notice of proposed action, is amended to add a 
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 under part 63.
    Section 2.714--A reference to part 63 is added in the section on 
interventions in any hearing on a license application for a repository.
    Section 2.1013--A reference to part 63 is added in the section on 
use of the

[[Page 55785]]

electronic docket (Licensing Support Network) for a license application 
for a repository.
    Section 2.1014--A reference to part 63 is added in the section on 
procedures for intervention and for filing an amendment to a 
contention.
    Section 2.1021--A reference to part 63 is added in the section on 
procedures for conducting the first prehearing conference.
    Section 2.1023--A reference to part 63 is added in the section 
containing criteria for immediate effectiveness of a decision on 
issuance or amendment of a construction authorization for a repository.

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.''
    Section 19.20--A reference to part 63 is added in the section on 
employee protection to make employee protection provisions applicable 
to employees engaged in protected activities under part 63.

10 CFR Part 20

    Section 20.1002, Scope, is amended to make part 63 subject to the 
regulations in part 20.
    Section 20.1003--A reference to part 63 is added to the definition 
of ``License'' in the definitions section.
    Section 20.1401--A reference to part 63 is added to the section on 
general provisions and scope of radiological criteria for license 
termination to make these provisions applicable to decommissioning 
facilities licensed under part 63.
    Section 20.2001--A reference to part 63 is added to the section on 
general requirements for waste disposal.
    Section 20.2206--A reference to part 63 is added to the section on 
reports of individual monitoring to make requirements for individual 
monitoring applicable to a part 63 licensee.

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 are amended to include part 63.
    Section 21.21 is amended to make part 63 subject to the regulations 
for reporting defects and noncompliance.

10 CFR Part 30

    Section 30.11, Specific exemptions, is amended to exempt DOE from 
part 30 regulations for activities subject to part 63.

10 CFR Part 40

    Section 40.14, Specific exemptions, is amended to exempt DOE 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 a 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 a 
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 a 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 a 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.
    In Sec. 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 a reference 
to part 63 in the definition of a geologic repository.

10 CFR Part 70

    Section 70.17--A reference to part 63 is added to the section on 
specific exemptions to exempt DOE activities that are subject to part 
63 or part 60 from the requirements of part 70.

10 CFR Part 72

    Section 72.44--A reference to part 63 is added to the section on 
license conditions. Part 72 already contains a provision limiting the 
quantity of spent fuel at the site of a monitored retrievable storage 
facility until a repository authorized under NWPA and part 60 begins 
operations. This change allows for a repository authorized under part 
63 as well.

10 CFR Part 73

    Section 73.1--A reference to part 63 is added to the section on 
purpose and scope. This makes certain requirements for the 
establishment and maintenance of a physical protection system 
applicable to a repository licensed under part 63 in addition to part 
60.
    Section 73.51--A reference to part 63 is added to the section on 
requirements for physical protection of spent fuel and HLW. 
Applicability of these requirements is extended to the GROA licensed 
under part 63.

10 CFR Part 75

    Section 75.4--A reference to part 63 is added to the definition of 
``Installation'' in the definitions section. This identifies locations 
where possession of more than 1 effective kilogram of nuclear material 
requires certain safeguards requirements.

VII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995, Pub. 
L. 104-113, requires that Federal agencies use technical standards that 
are developed or adopted by voluntary consensus standards bodies unless 
using such a standard is inconsistent with applicable law or otherwise 
impractical. In this final rule, the NRC is publishing licensing 
criteria for the disposal of spent nuclear fuel and high-level 
radioactive waste in the proposed geologic repository at Yucca 
Mountain, Nevada. This action does not constitute the establishment of 
a standard that contains generally applicable requirements.

VIII. Finding of No Significant Environmental Impact: Availability

    Pursuant to section 121(c) of the Nuclear Waste Policy Act, this 
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.

IX. Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). These requirements were approved by the Office of Management and 
Budget, approval number 3150-0199.
    The public reporting burden for this information collection is 
estimated to average 121 hours per response, including the time for 
reviewing instructions, searching existing data

[[Page 55786]]

sources, gathering and maintaining the data needed, and completing and 
reviewing the information collection. Send comments on any aspect of 
this information collection, including suggestions for reducing the 
burden, to the Records Management Branch (T-6E6), U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, or by Internet 
electronic mail at [email protected]; and to the Desk Officer, Office of 
Information and Regulatory Affairs, NEOB-10202, (3150-0199), Office of 
Management and Budget, Washington, DC 20503.

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.

X. Regulatory Analysis

    The NRC has prepared a regulatory analysis for this regulation. The 
analysis examines the alternatives considered by NRC. The analysis is 
available for inspection in the NRC's Public Electronic Reading Room at 
http://www.nrc.gov/NRC/ADAMS/index.html.
    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].

XI. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act (5 U.S.C. 
605(b)), the Commission certifies that this final rule does not have a 
significant economic impact on a substantial number of small entities. 
This final 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.

XII. Backfit Analysis

    The NRC has determined that the backfit rule, 10 CFR 50.109, does 
not apply to this final rule and, therefore, a backfit analysis is not 
required because these amendments do not involve any provisions that 
would impose backfits as defined in 10 CFR 50.109(a)(1).

XIII. Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of OMB.

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, Source material, Special nuclear 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 materials, Nuclear 
power plants and reactors, 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, Reporting and recordkeeping requirements, Waste treatment and 
disposal.

10 CFR Part 70

    Criminal penalties, Hazardous materials transportation, Material 
control and accounting, Nuclear materials, Packaging and containers, 
Radiation protection, Reporting and recordkeeping requirements, 
Scientific equipment, Security measures, Special nuclear material.

10 CFR Part 72

    Administrative practice and procedure, Criminal Penalties, Manpower 
training programs, Nuclear materials, Occupational safety and health, 
Penalties, Radiation protection, Reporting and recordkeeping 
requirements, Security measures, Spent fuel, Whistleblowing.

10 CFR Part 73

    Criminal penalties, Export, Hazardous materials transportation, 
Import, Nuclear materials, Nuclear power plants and reactors, Reporting 
and recordkeeping requirements, Security measures.

10 CFR Part 75

    Criminal penalties, Intergovernmental relations, Nuclear materials, 
Nuclear power plants and reactors, Reporting and recordkeeping 
requirements, Security measures.
    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 adopting the following 
amendments to 10 CFR parts 2, 19, 20, 21, 30, 40, 51, 60, 61, 70, 72, 
73, and 75, and adding the new 10 CFR part 63.

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

[[Page 55787]]

(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, 183i, 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). Section 2.205(j) 
also issued under Pub. L. 101-410, 104 Stat. 90, as amended by 
section 3100(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). Subpart M also issued under sec. 184 (42 
U.S.C. 2234) and 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 part 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) If a tendered document is acceptable for docketing, the 
applicant will be requested to 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; 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 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. 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 are 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). The Secretary will transmit a notice of hearing on 
an application for a license under part 72 of this chapter to acquire, 
receive or possess spent fuel, high-level radioactive waste or 
radioactive material associated with high-level radioactive waste for 
the purpose of storage in a monitored retrievable storage installation 
(MRS) to the same persons who received notice of docketing under 
Sec. 72.16(e) of this chapter.
    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 part 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 55788]]

    7. Section 2.714 is amended by revising paragraph (d) to read as 
follows:


Sec. 2.714  Intervention.

* * * * *
    (d) The Commission, the presiding officer, or the Atomic Safety and 
Licensing Board designated to rule on petitions to intervene and/or 
requests for hearing shall permit intervention, in any hearing on an 
application for a license to receive and possess high-level radioactive 
waste at a geologic repository operations area, by the State in which 
such area is located and by any affected Indian Tribe as defined in 
part 60 or 63 of this chapter.
* * * * *
    8. In Sec. 2.1001, the definitions of Documentary material, 
Interested governmental participation, Licensing Support Network, and 
Party are revised to read as follows:


Sec. 2.1001  Definitions.

* * * * *
    Documentary material means any information upon which a party, 
potential party, or interested governmental participant intends to rely 
and/or to cite in support of its position in the proceeding 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; any information that is known to, and in the possession of, or 
developed by the party that is relevant to, but does not support, that 
information or that party's position; and all reports and studies, 
prepared by or on behalf of the potential party, interested 
governmental participant, or party, including all related ``circulated 
drafts,'' relevant to both the license application and the issues set 
forth in the Topical Guidelines in Regulatory Guide 3.69, regardless of 
whether they will be relied upon and/or cited by a party. The scope of 
documentary material shall be guided by the topical guidelines in the 
applicable NRC Regulatory Guide.
* * * * *
    Interested governmental participant means any person admitted under 
Sec. 2.715(c) of this part to the proceeding on an application 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.
    Licensing Support Network means the combined system that makes 
documentary material available electronically to parties, potential 
parties, and interested governmental participants to the proceeding 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, as part of the electronic docket or electronic access to 
documentary material, beginning in the pre-license application phase.
* * * * *
    Party for the purpose of this subpart means the DOE, the NRC staff, 
the host State, any affected unit of local government as defined in 
section 2 of the Nuclear Waste Policy Act of 1982, as amended (42 
U.S.C. 10101), any affected Indian Tribe as defined in section 2 of the 
Nuclear Waste Policy Act of 1982, as amended (42 U.S.C. 10101), and a 
person admitted under Sec. 2.1014 to the proceeding on an application 
for a license to receive and possess high-level radioactive waste at a 
geologic repository operations area under part 60 or 63 of this 
chapter, provided that a host State, affected unit of local government, 
or affected Indian Tribe shall file a list of contentions in accordance 
with the provisions of Sec. 2.1014(a)(2)(ii) and (iii).
* * * * *
    9. Section 2.1013 is amended by revising paragraphs (a)(2) and 
(c)(1) to read as follows:


Sec. 2.1013  Use of the electronic docket during the proceeding.

    (a) * * *
    (2) Commencing with the docketing in an electronic form of the 
license application to receive and possess high-level radioactive waste 
at a geologic repository operations area pursuant to part 60 or 63 of 
this chapter, the Secretary of the Commission, upon determining that 
the application can be properly accessed under the Commission's 
electronic docket rules, will establish an electronic docket to contain 
the official record materials of the high-level radioactive waste 
licensing proceeding in searchable full text, or, for material that is 
not suitable for entry in searchable full text, by header and image, as 
appropriate.
* * * * *
    (c)(1) All filings in the adjudicatory proceeding on the license 
application to receive and possess high-level radioactive waste at a 
geologic repository operations area pursuant to part 60 or 63 of this 
chapter shall be transmitted electronically by the submitter to the 
Presiding Officer, parties, and the Secretary of the Commission, 
according to established format requirements. Parties and interested 
governmental participants will be required to use a password security 
code for the electronic transmission of these documents.
* * * * *
    10. Section 2.1014 is amended by revising the introductory text of 
paragraph (a)(1) and paragraph (a)(4) to read as follows:


Sec. 2.1014  Intervention.

    (a)(1) Any person whose interest may be affected by a proceeding on 
the application 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 who desires to participate as a 
party, shall file a written petition for leave to intervene. In a 
proceeding noticed pursuant to Sec. 2.105, any person whose interest 
may be affected may also request a hearing. The petition and/or 
request, and any request to participate under Sec. 2.715(c), shall be 
filed within thirty days after the publication of the notice of hearing 
in the Federal Register. Nontimely filings will not be entertained 
absent a determination by the Commission, or the Presiding Officer 
designated to rule on the petition and/or request, that the petition 
and/or request should be granted based upon a balancing of the 
following factors, in addition to satisfying those set out in 
paragraphs (a)(2) and (c) of this section:
* * * * *
    (4) Any party may amend its contentions specified in paragraph 
(a)(2)(ii) of this section. The Presiding Officer shall rule on any 
petition to amend such contentions based on the balancing of the 
factors specified in paragraph (a)(1) of this section and a showing 
that a significant safety or environmental issue is involved or that 
the amended contention raises a material issue related to the 
performance evaluation anticipated by Secs. 60.112 and 60.113 or 
Secs. 63.112 and 63.113 of this chapter.
* * * * *
    11. Section 2.1021 is amended by revising the introductory text of 
paragraph (a) to read as follows:


Sec. 2.1021  First prehearing conference.

    (a) In any proceeding involving an application 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, 
the Commission or the Presiding Officer will direct the parties, 
interested governmental participants, and any petitioners for 
intervention, or their counsel, to appear at a specified time and 
place, within seventy days after the notice of hearing is published, or 
such

[[Page 55789]]

other time as the Commission or the Presiding Officer may deem 
appropriate, for a conference to:
* * * * *
    12. Section 2.1023 is amended by revising the introductory text of 
paragraph (a) to read as follows:


Sec. 2.1023  Immediate effectiveness.

    (a) Pending review and final decision by the Commission, an initial 
decision resolving all issues before the Presiding Officer in favor of 
issuance or amendment of a construction authorization pursuant to 
Sec. 60.31 or 63.31 of this chapter or a license to receive and possess 
high-level radioactive waste at a geologic repository operations area 
pursuant to Sec. 60.41 or 63.41 of this chapter, will be immediately 
effective upon issuance except--
* * * * *

PART 19--NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS; INSPECTION 
AND INVESTIGATIONS

    13. 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).

    14. 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 under 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 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 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.
    15. 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 72 of this chapter, including 
licenses to operate a production or utilization facility pursuant to 
part 50 of this chapter.
* * * * *
    16. Section 19.20 is revised to read as follows:


Sec. 19.20  Employee protection.

    Employment discrimination by a licensee (or a holder of a 
certificate of compliance issued pursuant to part 76) or a contractor 
or subcontractor of a licensee (or a holder of a certificate of 
compliance issued pursuant to part 76) against an employee for engaging 
in protected activities under this part or parts 30, 40, 50, 60, 61, 
63, 70, 72, 76, or 150 of this chapter is prohibited.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION


    17. 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, 2133, 
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).

    18. 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, 50, 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.
    19. Section 20.1003 is amended by revising the definition of 
License to read as follows:


Sec. 20.1003  Definitions.

* * * * *
    License means a license issued under the regulations in parts 30 
through 36, 39, 40, 50, 60, 61, 63, 70, or 72 of this chapter.
* * * * *
    20. Section 20.1401 is amended by revising paragraph (a) to read as 
follows:


Sec. 20.1401  General provisions and scope.

    (a) The criteria in this subpart apply to the decommissioning of 
facilities licensed under parts 30, 40, 50, 60, 61, 63, 70, and 72 of 
this chapter, as well as other facilities subject to the Commission's 
jurisdiction under the Atomic Energy Act of 1954, as amended, and the 
Energy Reorganization Act of 1974, as amended. For high-level and low-
level waste disposal facilities (10 CFR parts 60, 61, and 63), the 
criteria apply only to ancillary surface facilities that support 
radioactive waste disposal activities. The criteria do not apply to 
uranium and thorium recovery facilities already subject to Appendix A 
to 10 CFR part 40 or to uranium solution extraction facilities.
* * * * *
    21. Section 20.2001 is amended by revising paragraphs (a)(1) and 
(b)(5) to read as follows:


Sec. 20.2001  General requirements.

    (a) * * *
    (1) By transfer to an authorized recipient as provided in 
Sec. 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 
72 of this chapter;
* * * * *
    (b) * * *
    (5) Disposal at a geologic repository under part 60 or part 63 of 
this chapter.
    22. Section 20.2206 is amended by revising paragraph (a)(4) to read 
as follows:


Sec. 20.2206  Reports of individual monitoring.

    (a) * * *
    (4) Possess high-level radioactive waste at a geologic repository 
operations area pursuant to part 60 or 63 of this chapter; or
* * * * *

PART 21--REPORTING OF DEFECTS AND NONCOMPLIANCE

    23. 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.

[[Page 55790]]

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).

    24. 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 part 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]

    25. In Sec. 21.3, the definitions of Basic component, Commercial 
grade item, and Dedication are amended by adding the number 63 after 
``10 CFR parts 30, 40, 50 (other than nuclear power plants), 60'' and 
the definition of Substantial safety hazard is amended by adding the 
number 63 between ``61'' and ``70.''
    26. 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, 71, 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, 71, or 72 of this chapter.
* * * * *

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


    27. 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).
    Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (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).

    28. Section 30.11 is amended by revising paragraph (c) to read as 
follows:


Sec. 30.11  Specific exemptions.

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

PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL

    29. 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); sec. 193, 104 Stat. 2835, as 
amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 
2243).
    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).

    30. Section 40.14 is amended by revising paragraph (c) to read as 
follows:


Sec. 40.14  Specific exemptions.

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

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

    31. 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)).

    32. 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 part 60 or part 63 of this chapter.
* * * * *
    33. Section 51.22 is amended by revising the introductory text of 
paragraph (c)(3) and paragraphs (c)(10), (c)(12), and (d) to read as 
follows:

[[Page 55791]]

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 under 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.
* * * * *
    (12) Issuance of an amendment to a license pursuant to parts 50, 
60, 61, 63, 70, 72, or 75 of this chapter relating solely to safeguards 
matters (i.e., protection against sabotage or loss or diversion of 
special nuclear material) or issuance of an approval of a safeguards 
plan submitted pursuant to parts 50, 70, 72, and 73 of this chapter, 
provided that the amendment or approval does not involve any 
significant construction impacts. These amendments and approvals are 
confined to--
    (i) Organizational and procedural matters;
    (ii) Modifications to systems used for security and/or materials 
accountability;
    (iii) Administrative changes; and
    (iv) Review and approval of transportation routes pursuant to 10 
CFR 73.37.
* * * * *
    (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 part 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.
    34. 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 NRC shall follow the procedures set out in 
paragraph (a) of this section.
    35. 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 part 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 the 
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 to the required time and manner of submission.)
* * * * *

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

    36. 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).

    37. 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

    38. 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).

    39. 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--

[[Page 55792]]

    (1) Disposal of high-level waste as provided for in part 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.
* * * * *
    40. In Sec. 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 part 60 or 63 is not considered a land 
disposal facility.
* * * * *
    41. 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 
part 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.
* * * * *
    42. 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.


63.1  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, Affected Units of Local 
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.
Subpart E--Technical Criteria
63.101  Purpose and nature of findings.
63.102  Concepts.

Preclosure Performance Objectives

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

Preclosure Safety Analysis

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

Postclosure Performance Objectives

63.113  Performance objectives for the geologic repository after 
permanent closure.

Postclosure Performance Assessment

63.114  Requirements for performance assessment.
63.115  Requirements for multiple barriers.

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  Quality assurance criteria.
63.143  Implementation.
63.144  Quality assurance program change.
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.
Subpart K--Preclosure Public Health and Environmental Standards
63.201  Purpose and scope.
63.202  Definitions for Subpart K.
63.203  Implementation of Subpart K.
63.204  Preclosure standard. ;
Subpart L--Postclosure Public Health and Environmental Standards
63.301  Purpose and scope.
63.302  Definitions for Subpart L.
63.303  Implementation of Subpart L.
63.304  Reasonable expectation.
63.305  Required characteristics of the reference biosphere.

Postclosure Individual Protection Standard

63.311  Individual protection standard after permanent closure.
63.312  Required characteristics of the reasonably maximally exposed 
individual.

Human-Intrusion Standard

63.321  Individual protection standard for human intrusion.
63.322  Human intrusion scenario.

Ground-Water Protection Standards

63.331  Separate standards for protection of ground water.
63.332  Representative volume.

ADDITIONAL PROVISIONS

63.341  Projections of peak dose.
63.342  Limits on performance assessments.
63.343  Severability of individual protection and ground-water 
protection standards.


[[Page 55793]]


    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 10 CFR 60.1, 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 location 
of the facility if the Secretary of the Interior finds, on the petition 
of the appropriate governmental officials of the Tribe, that the 
effects are both substantial and adverse to the Tribe.
    Barrier means any material, structure, or feature that, for a 
period to be determined by NRC, prevents or substantially reduces the 
rate of movement of water or radionuclides from the Yucca Mountain 
repository to the accessible environment, or prevents the release or 
substantially reduces the release rate of radionuclides from the waste. 
For example, a barrier may be a geologic feature, an engineered 
structure, a canister, a waste form with physical and chemical 
characteristics that significantly decrease the mobility of 
radionuclides, or a material placed over and around the waste, provided 
that the material substantially delays movement of water or 
radionuclides.
    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.
    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 constraints 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.
    Director means the Director of the Nuclear Regulatory Commission's 
Office of Nuclear Material Safety and Safeguards.
    Disposal means the emplacement of radioactive waste 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, including 
engineered components and systems other than the waste package (e.g., 
drip shields), and the underground facility.
    Event sequence means a series of actions and/or occurrences within 
the natural and engineered components of a geologic repository 
operations area that could potentially lead to exposure of individuals 
to radiation. An event sequence includes one or more initiating events 
and associated combinations of repository system component failures, 
including those produced by the action or inaction of operating 
personnel. Those event sequences that are expected to occur one or more 
times before permanent closure of the geologic repository operations 
area are referred to as Category 1 event sequences. Other event 
sequences that have at least one chance in 10,000 of occurring before 
permanent closure are referred to as Category 2 event sequences.
    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.
    High-level radioactive waste or HLW means:
    (1) The highly radioactive material resulting from the reprocessing 
of spent nuclear fuel, including liquid waste produced directly in 
reprocessing and any solid material derived from such liquid waste that 
contains fission products in sufficient concentrations;
    (2) Irradiated reactor fuel; and
    (3) Other highly radioactive material that the Commission, 
consistent with existing law, determines by rule requires permanent 
isolation.
    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

[[Page 55794]]

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 event 
sequences; or
    (2) To prevent or mitigate Category 2 event sequences that could 
result in radiological exposures exceeding the values specified at 
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 a reasonable expectation that high-level waste can be disposed 
of without exceeding the requirements of Sec. 63.113(b) and (c).
    Initiating event means a natural or human induced event that causes 
an event sequence.
    Isolation means inhibiting the transport of radioactive material 
to:
    (1) The location of the reasonably maximally exposed individual so 
that radiological exposures will not exceed the requirements of 
Sec. 63.113(b); and
    (2) The accessible environment so that releases of radionuclides 
into the accessible environment will not exceed the requirements of 
Sec. 63.113(c).
    Performance assessment means an analysis that:
    (1) Identifies the features, events, processes (except human 
intrusion), and sequences of events and processes (except human 
intrusion) that might affect the Yucca Mountain disposal system and 
their probabilities of occurring during 10,000 years after disposal;
    (2) Examines the effects of those features, events, processes, and 
sequences of events and processes upon the performance of the Yucca 
Mountain disposal system; and
    (3) Estimates the dose incurred by the reasonably maximally exposed 
individual, including the associated uncertainties, as a result of 
releases caused by all significant features, events, processes, and 
sequences of events and processes, weighted by their probability of 
occurrence.
    Performance confirmation means the program of tests, experiments, 
and analyses that is conducted to evaluate the adequacy of the 
information used to demonstrate compliance with the performance 
objectives in subpart E of this part.
    Permanent closure means final backfilling of the underground 
facility, if appropriate, and the sealing of shafts, ramps, and 
boreholes.
    Preclosure safety analysis means a systematic examination of the 
site; the design; and the potential hazards, initiating events and 
event sequences and their consequences (e.g., radiological exposures to 
workers and the public). The analysis identifies structures, systems, 
and components important to safety.
    Public Document Room means the place at One White Flint North, 
11555 Rockville Pike, Room O-1F13, Rockville, MD, 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.
    Reasonably maximally exposed individual means the hypothetical 
person meeting the criteria specified at Sec. 63.312.
    Reference biosphere means the description of the environment 
inhabited by the reasonably maximally exposed individual. 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 permanently 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 statistically all voids, large and small, 
are 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.
    Total effective dose equivalent (TEDE) means, for purposes of 
assessing doses to workers, the sum of the deep-dose equivalent (for 
external exposures) and the committed effective dose equivalent (for 
internal exposures). For purposes of assessing doses to members of the 
public (including the RMEI), TEDE means the sum of the effective dose 
equivalent (for external exposures) and the committed effective dose 
equivalent (for internal exposures).
    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 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.

[[Page 55795]]

    Water table means that surface in a ground-water body, separating 
the unsaturated zone from the saturated zone, at which the water 
pressure is atmospheric.


Sec. 63.3  License required.

    (a) DOE may 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 under this part.
    (b) DOE may 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 is 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 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 if the 
copy or microform is authenticated by authorized personnel and 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 is binding on the Commission.


Sec. 63.6  Exemptions.

    The Commission may, upon application by DOE, any interested person, 
or upon its own initiative, grant an exemption from the requirements of 
this part if it determines that the exemption is authorized by law, 
does not endanger life nor property nor the common defense and 
security, and is 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 Nuclear Regulatory Commission has submitted the information 
collection requirements contained in this part to the Office of 
Management and Budget (OMB) for approval as required by the Paperwork 
Reduction Act (44 U.S.C. 3501, et seq.). The NRC may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has approved the information collection requirements contained in 
this part under control number 3150-0199.
    (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 does not apply 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.
    (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; or
    (3) Other enforcement action.
    (d) Actions taken by an employer, or others, that adversely affect 
an

[[Page 55796]]

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 a 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 must 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 must be provided to 
the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear 
Regulatory Commission, 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) DOE shall conduct a program of site characterization with 
respect to the Yucca Mountain site before it submits an application for 
a license to be issued under this part.
    (b) DOE shall conduct the investigations to obtain the required 
information in a manner that limits adverse effects on the long-term 
performance of the geologic repository at Yucca Mountain to the extent 
practical.


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

    (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.
---------------------------------------------------------------------------

    \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 at the staff level.
---------------------------------------------------------------------------

    (b) During the conduct of site characterization activities at the 
Yucca Mountain site, DOE shall report the nature and extent of the 
activities, the information that has been developed, and the progress 
of waste form and waste package research and development to the 
Commission not less than once every 6 months. The semiannual reports 
must 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 site 
characterization must 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

[[Page 55797]]

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, the 
Director shall comment whenever he or she 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 by placing 
the comments in a public forum to allow the public to comment on them 
after the Director's comments are sent to DOE.
    (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 resulting from the 
requirements of this section, including the reports described in 
paragraph (b) of this section, must 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 Board, other presiding 
officers, or the Director, in any such proceeding.

License Application


Sec. 63.21  Content of application.

    (a) An application consists of general information and a Safety 
Analysis Report. An environmental impact statement must be prepared in 
accordance with the Nuclear Waste Policy Act of 1982, as amended, and 
must accompany the application. Any Restricted Data or National 
Security Information must be separated from unclassified information. 
The application must be as complete as possible in the light of 
information that is reasonably available at the time of docketing.
    (b) The general information must 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 description of the detailed security measures for 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 must 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 
must 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 must 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; and
    (iv) Information regarding the location of the reasonably maximally 
exposed individual, and regarding local human behaviors and 
characteristics, as needed to support selection of conceptual models 
and parameters used for the reference biosphere and reasonably 
maximally exposed individual.
    (2) 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.
    (3) A description and discussion of the design of the various 
components of the geologic repository operations area and the 
engineered barrier system including:
    (i) Dimensions, material properties, specifications, analytical and 
design methods used along with any applicable codes and standards;
    (ii) The design criteria used and their relationships to the 
preclosure and postclosure performance objectives specified at 
Sec. 63.111(b), Sec. 63.113(b), and Sec. 63.113(c); and
    (iii) The design bases and their relation to the design criteria.
    (4) 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.
    (5) A preclosure 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 is 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.
    (6) A description of the program for control and monitoring of 
radioactive effluents and occupational radiological exposures to 
maintain such effluents and exposures in accordance with the 
requirements of Sec. 63.111.
    (7) A description of plans for retrieval and alternate storage of 
the radioactive wastes, should retrieval be necessary.
    (8) A description of design considerations that are intended to 
facilitate permanent closure and decontamination or decontamination and 
dismantlement of surface facilities.
    (9) 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--whether beneficial or potentially 
adverse to performance of the geologic repository--have been 
characterized, and the extent to which they affect waste isolation. 
Investigations must extend from the surface to a depth sufficient to 
determine principal pathways for radionuclide migration from the 
underground facility. Specific features,

[[Page 55798]]

events, and processes of the geologic setting must be investigated 
outside of the site if they affect performance of the geologic 
repository.
    (10) 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 water.
    (11) An assessment of the ability of the proposed geologic 
repository to limit radiological exposures to the reasonably maximally 
exposed individual for the period after permanent closure, as required 
by Sec. 63.113(b).
    (12) An assessment of the ability of the proposed geologic 
repository to limit releases of radionuclides into the accessible 
environment as required by Sec. 63.113(c).
    (13) An assessment of the ability of the proposed geologic 
repository to limit radiological exposures to the reasonably maximally 
exposed individual for the period after permanent closure in the event 
of human intrusion into the engineered barrier system as required by 
Sec. 63.113(d).
    (14) An evaluation of the natural features of the geologic setting 
and design features of the engineered barrier system that are 
considered barriers important to waste isolation as required by 
Sec. 63.115.
    (15) An explanation of measures used to support the models used to 
provide the information required in paragraphs (c)(9) through (c)(14) 
of this section. Analyses and models that will be used to assess 
performance of the geologic repository must 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.
    (16) An identification of those structures, systems, and components 
of the geologic repository, both surface and subsurface, that 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.
    (17) A description of the performance confirmation program that 
meets the requirements of subpart F of this part.
    (18) 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 must be 
given to those items that may significantly influence the final design.
    (19) An explanation of how expert elicitation was used.
    (20) 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. The 
description of the quality assurance program must include a discussion 
of how the applicable requirements of Sec. 63.142 will be satisfied.
    (21) 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 decontamination and 
dismantlement of surface facilities, as required by Sec. 63.161.
    (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 decontamination and 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.
    (23) A description of the program to be used to maintain the 
records described in Secs. 63.71 and 63.72.
    (24) 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.


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, 
any amendments to the application, and an accompanying environmental 
impact statement and any supplements, must be signed by the Secretary 
of Energy or the Secretary's authorized representative and must be 
filed in triplicate with the Director.
    (b) DOE shall submit 30 additional copies of each portion of the 
application and any amendments, and each environmental impact statement 
and any supplements. DOE shall retain another 120 copies for 
distribution in accordance with written instructions from the Director 
or the Director's designee.
    (c) On notification of the appointment of an Atomic Safety and 
Licensing Board, DOE shall 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 must be served in the 
same manner.
    (d) When an application, and any amendment to it is filed, copies 
must be made available in appropriate locations near the proposed 
geologic repository operations area at the Yucca Mountain site for 
inspection by the public. These copies must be updated as amendments to 
the application are made. The environmental impact statement and any 
supplements to it must be made available in the same manner. An updated 
copy of the application, and the environmental impact statement and 
supplements, must 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 these documents submitted as required 
by this part.

[[Page 55799]]

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, if the 
references are clear and specific and copies of the information 
incorporated are made available to the public locations near the site 
of the proposed geologic repository, as specified in Sec. 63.22(d).


Sec. 63.24  Updating of application and environmental impact statement.

    (a) The application must be as complete as possible in light of the 
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--
    (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.
    (1) That there is reasonable assurance that the types and amounts 
of radioactive materials described in the application can be received 
and possessed in a geologic repository operations area of the design 
proposed without unreasonable risk to the health and safety of the 
public; and
    (2) That there is reasonable expectation that the materials can be 
disposed of without unreasonable risk to the health and safety of the 
public.
    (3) In arriving at these determinations, the Commission shall 
consider whether--
    (i) DOE has described the proposed geologic repository as specified 
at Sec. 63.21;
    (ii) The site and design comply with the performance objectives and 
requirements contained in subpart E of this part;
    (iii) DOE's quality assurance program complies with the 
requirements of subpart G of this part;
    (iv) DOE's personnel training program complies with the criteria 
contained in subpart H of this part;
    (v) DOE's emergency plan complies with the criteria contained in 
subpart I of this part; and
    (vi) 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 the 
issuance of the construction authorization, with any appropriate 
conditions to protect environmental values.


Sec. 63.32  Conditions of construction authorization.

    (a) In a construction authorization for a geologic repository 
operations area at the Yucca Mountain site, the Commission shall 
include any conditions it considers necessary to protect the health and 
safety of the public, the common defense and security, or environmental 
values.
    (b) The Commission shall incorporate provisions in the construction 
authorization 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 must 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 may not be issued by the Commission until;
    (1) DOE has updated its application, as specified at 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 
must be filed with the Commission that fully describes any desired 
changes and follows, as far as applicable, the content requirements 
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--

[[Page 55800]]

    (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 considered 
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 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 decontamination and dismantlement of surface 
facilities.
    (e) All applicable requirements of part 51 of this chapter have 
been satisfied.


Sec. 63.42  Conditions of license.

    (a) The Commission shall include any conditions, including license 
specifications, it considers necessary to protect the health and safety 
of the public, the common defense and security, and environmental 
values in a license issued under this part.
    (b) Whether stated in the license or not, the following are 
considered to be conditions in every license issued:
    (1) The license is 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 is 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 are 
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 includes 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 includes the provisions set 
forth in section 114(d) of the Nuclear Waste Policy Act, as amended, 
defining the quantity of solidified high-level radioactive waste and 
spent nuclear 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 includes license conditions 
derived from the analyses and evaluations included in the application, 
including amendments made before a license is issued, together with any 
additional conditions the Commission finds appropriate.
    (b) License conditions 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) Definitions for the purposes of this section:
    (1) Change means a modification or addition to, or removal from, 
the geologic repository operations area design or procedures that 
affects a design function, event sequence, method of performing or 
controlling the function, or an evaluation that demonstrates that 
intended functions will be accomplished.
    (2) Departure from a method of evaluation described in the Safety 
Analysis Report (SAR) (as updated) used in establishing the preclosure 
safety analyses or performance assessment means:
    (i) Changing any of the elements of the method described in the SAR 
(as updated) unless the results of the analysis are conservative or 
essentially the same; or
    (ii) Changing from a method described in the SAR to another method 
unless that method has been approved by NRC for the intended 
application, addition or removal.
    (3) Safety Analysis Report (SAR) (as updated) means the Safety 
Analysis Report for the geologic repository, submitted in accordance 
with Sec. 63.21, as updated in accordance with Sec. 63.24.
    (4) Geologic repository operations area as described in the SAR (as 
updated) means:
    (i) The structures, systems, and components important to safety or 
barriers important to waste isolation that are described in the SAR (as 
updated); and
    (ii) The design and performance requirements for such structures, 
systems, and components described in the SAR (as updated).
    (5) Procedures as described in the SAR (as updated) means those 
procedures that contain information described in the SAR (as updated) 
such as how structures, systems, and components important to safety, or 
important to waste isolation, are operated or controlled.
    (6) Tests or experiments not described in the SAR (as updated) 
means any condition where the geologic repository operations area or 
any of its structures, systems, and components important to safety, or 
important to waste isolation, are utilized, controlled, or altered in a 
manner which is either:
    (i) Outside the reference bounds of the design bases as described 
in the SAR (as updated); or
    (ii) Inconsistent with the analyses or descriptions in the SAR (as 
updated).
    (b)(1) DOE may make changes in the geologic repository operations 
area as described in the SAR (as updated), make changes in the 
procedures as described in the SAR (as updated), and conduct tests or 
experiments not described in the SAR (as updated), without obtaining 
either an amendment of construction authorization under Sec. 63.33 or a 
license amendment under Sec. 63.45, if:
    (i) A change in the conditions incorporated in the construction 
authorization or license is not required; and

[[Page 55801]]

    (ii) 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 
under Sec. 63.33 or a license amendment under Sec. 63.45, before 
implementing a change, test, or experiment if it would:
    (i) Result in more than a minimal increase in the frequency of 
occurrence of an event sequence previously evaluated in the SAR (as 
updated);
    (ii) Result in more than a minimal increase in the likelihood of 
occurrence of a malfunction of structures, systems, components 
important to safety, or important to waste isolation, which were 
previously evaluated in the SAR (as updated);
    (iii) Result in more than a minimal increase in the consequences of 
an event sequence previously evaluated in the SAR (as updated);
    (iv) Result in more than a minimal increase in the consequences of 
malfunction of structures, systems, components important to safety, or 
important to waste isolation, which were previously evaluated in the 
SAR (as updated);
    (v) Create the possibility for an event sequence, or of a pathway 
for release of radionuclides, of a different type than any evaluated 
previously in the SAR (as updated);
    (vi) Create the possibility for a malfunction of structures, 
systems, and components important to safety, or important to waste 
isolation, with a different result than any evaluated previously in the 
SAR (as updated);
    (vii) Result in a departure from a method of evaluation described 
in the SAR (as updated) used in establishing the preclosure safety 
analysis or the performance assessment.
    (3) In implementing this paragraph, the SAR (as updated) is 
considered to include SAR changes resulting from evaluations performed 
pursuant to this section and from safety analyses performed under 
Sec. 63.33 or Sec. 63.45, as applicable, after the last Safety Analysis 
Report was updated under Sec. 63.24.
    (4) The provisions in this section do not apply to changes to the 
geologic repository operations area or procedures when the applicable 
regulations establish more specific criteria for accomplishing such 
changes.
    (c)(1) DOE shall maintain records of changes in the geologic 
repository operations area at the Yucca Mountain site, of changes in 
procedures, and of tests and experiments made under paragraph (b) of 
this section. These records must 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 under paragraph (b) of this section.
    (2) No less frequently than every 24 months, DOE shall prepare 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 to 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 under 
this paragraph must be made a part of the public record of the 
licensing proceedings.
    (d) Changes to the quality assurance program description required 
by Sec. 63.21(c)(20) must be processed in accordance with Sec. 63.144.


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, a license amendment 
is required for any of the following activities:
    (1) Any action that would make emplaced high-level radioactive 
waste irretrievable or that would substantially increase the difficulty 
of retrieving the 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;
    (5) Any substantial change to the design or operating procedures 
from that specified in the license, except as authorized in Sec. 63.44; 
and
    (6) Permanent closure.
    (b) An application for an amendment must be filed, and will be 
reviewed, as specified in 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 must 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. The updated 
assessment must include any performance confirmation data collected 
under the program required by subpart F, and pertinent to compliance 
with Sec. 63.113.
    (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, these measures must 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, drip shields, waste packages, interactions between

[[Page 55802]]

natural and engineered systems, 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, 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 permanent closure, DOE shall also supplement 
its environmental impact statement and submit this statement, as 
supplemented, with the application for license amendment.


Sec. 63.52  Termination of license.

    (a) Following permanent closure and the decontamination or 
decontamination and dismantlement of surface facilities at the Yucca 
Mountain site, DOE may apply for an amendment to terminate the license.
    (b) The application must be filed and will be reviewed in 
accordance with the provisions of Sec. 63.45 and this section.
    (c) A license may 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 decontamination and 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, Affected Units of 
Local Government, and Affected Indian Tribes


Sec. 63.61  Provision of information.

    (a) The Director shall provide the Governor and the Nevada State 
legislature, affected units of local government, and the governing body 
of any affected Indian Tribe, with timely and complete information 
regarding determinations or plans made by the Commission with respect 
to the Yucca Mountain site. Information must be provided concerning 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 site.
    (b) Notwithstanding paragraph (a) of this section, the Director is 
not required to distribute any document to any entity if, with respect 
to the document, that entity or its counsel is included on a service 
list prepared under part 2 of this chapter.
    (c) Copies of all communications by the Director under this section 
must be placed in the Public Document Room and furnished to DOE.


Sec. 63.62  Site review.

    (a) The Director shall make the NRC staff available to consult with 
representatives of the State of Nevada, affected units of local 
government, and affected Indian Tribes regarding the status of site 
characterization at the Yucca Mountain site.
    (b) Requests for consultation must 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, affected units of local 
government, and Tribe participation in the Commission's regulatory 
activities.
    (3) Cooperation in development of proposals for State, affected 
units of local government, and Tribal participation in license reviews.


Sec. 63.63  Participation in license reviews.

    (a) The State, affected units of local government, and affected 
Indian Tribes may participate in license reviews as provided in subpart 
J of part 2 of this chapter.
    (b) In addition, a State, or an affected unit of local government, 
or an affected Indian Tribe may submit a proposal to the Director to 
facilitate its participation in the review of the license application. 
The proposal may be submitted at any time and must contain a 
description and schedule of how the State, or affected unit of local 
government, or affected Indian Tribe wishes to participate in the 
review, or what services or activities the State, or affected unit of 
local government, or affected Indian Tribe wishes the NRC to carry out, 
and how the services or activities proposed to be carried out by the 
NRC would contribute to this participation. The proposal may include 
educational or information services (seminars, public meetings) or 
other actions on the part of NRC, such as 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 unit of local government, 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 affected unit of local government, 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 in paragraph (c) of this section, 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 unit of local 
government, or affected Indian Tribe may bear;
    (2) The proposed activities--
    (i) Will enhance communications between NRC and the State, or 
affected unit of local government, or affected Indian Tribe;
    (ii) Will make a productive and timely contribution to the review; 
and
    (iii) Are authorized by law.
    (e) The Director shall advise the State, or affected unit of local 
government, or affected Indian Tribe whether its proposal has been 
accepted or denied. If all or any part of a proposal is denied, the 
Director shall state the reason for the denial.
    (f) Proposals submitted under this section, and responses to them, 
must 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 the 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 of Nevada), for an 
affected unit of local government, 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 this capacity.

[[Page 55803]]

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


Sec. 63.71  Records and reports.

    (a) DOE shall maintain records and make reports in connection with 
the licensed activity that are 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 must 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)(3).


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)(3).
    (b) The records required under paragraph (a) of this section must 
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;
    (11) Details, methods of emplacement, and location of seals used; 
and
    (12) Facility design records (e.g, design specifications and ``as 
built'' drawings).


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) Adversely affect safety at any future time;
    (2) Represent a significant deviation from the design criteria and 
design basis stated in the design application; or
    (3) Represent a deviation from the conditions stated in the terms 
of a construction authorization or the license, including license 
specifications.
    (b) DOE shall implement a program for evaluating and reporting 
deviations and failures to comply, to identify defects and failures to 
comply associated with substantial safety hazards, based on the 
applicable requirements in 10 CFR 50.55(e) as it applies to the 
construction authorization and design of the geologic repository 
operations area at the Yucca Mountain site.
    (c) DOE shall implement a program of reporting specific events and 
conditions that is the same as that specified in 10 CFR 72.75.
    (d) The requisite notification must be as specified in the 
applicable regulation. Copies of the written report must be sent to the 
NRC Operations Center, Document Control Desk, U.S. NRC, to the Director 
of NMSS, U.S. NRC, and to the NRC onsite representative.


Sec. 63.74  Tests.

    (a) DOE shall perform, or permit the Commission to perform, those 
tests the Commission considers appropriate or necessary for the 
administration of the regulations in this part. This 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 must 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 must 
be furnished by DOE. The office must be convenient to and have full 
access to the facility and must provide the inspector both visual and 
acoustic privacy.
    (2) The space provided must 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 provided 
is subject to the approval of the Director, Office of 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 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 for postclosure performance of the geologic 
repository and other criteria that, if satisfied, support a finding of 
no unreasonable risk.

[[Page 55804]]

Postclosure performance objectives for the geologic repository include 
a requirement to limit radiological exposures to the reasonably 
maximally exposed individual, a requirement to limit releases of 
radionuclides to the accessible environment to protect ground water, 
and a requirement to limit radiological exposures to the reasonably 
maximally exposed individual in the event of human intrusion (see 
Sec. 63.113(b), (c), and (d), respectively).
    (2) Although the postclosure performance objectives specified at 
Sec. 63.113 are generally stated in unqualified terms, it is not 
expected that complete assurance that the requirements will be met can 
be presented. A reasonable expectation, on the basis of the record 
before the Commission, that the postclosure performance objectives will 
be met, is the general standard required. Proof that the geologic 
repository will conform with the objectives 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 expectation, 
making allowance for the time period, hazards, and uncertainties 
involved, that the outcome will conform with the objectives for 
postclosure performance for 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. Compliance demonstrations 
should not exclude important parameters from assessments and analyses 
simply because they are difficult to precisely quantify to a high 
degree of confidence. The performance assessments and analyses should 
focus upon the full range of defensible and reasonable parameter 
distributions rather than only upon extreme physical situations and 
parameter values. Further, in reaching a determination of reasonable 
expectation, 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 lists findings that must be made in support of an 
authorization to construct a geologic repository operations area at the 
Yucca Mountain site. Prior to closure, Sec. 63.31(a)(1) 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 stored in a geologic repository operations area of the 
design proposed without unreasonable risk to the health and safety of 
the public. After permanent closure, Sec. 63.31(a)(2) requires the 
Commission to consider whether there is a reasonable expectation the 
site and design comply with the postclosure performance objectives. 
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 paragraph (a)(2) of Sec. 63.31.


Sec. 63.102  Concepts.

    This section provides a functional overview of this Subpart E. In 
the event of any inconsistency, the definitions in Sec. 63.2 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) These regulations deal 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 the 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 shall 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 radiation levels and radiological exposures, in both 
restricted and unrestricted areas, and releases of radioactive 
materials to unrestricted areas, as specified at Sec. 63.111(a).
    (f) Preclosure safety analysis. Section 63.111 includes performance 
objectives for the geologic repository operations area for the period 
before permanent closure and decontamination or permanent closure, 
decontamination, and dismantlement of surface facilities. The 
preclosure safety analysis is a systematic examination of the site; the 
design; and the potential hazards, initiating events and their 
resulting event sequences and potential radiological exposures to 
workers and the public. Initiating events are to be considered for 
inclusion in the

[[Page 55805]]

preclosure safety analysis for determining event sequences only if they 
are reasonable (i.e., based on the characteristics of the geologic 
setting and the human environment, and consistent with precedents 
adopted for nuclear facilities with comparable or higher risks to 
workers and the public). The analysis identifies structures, systems, 
and components important to safety.
    (g) Performance objectives after permanent closure. After permanent 
closure, the geologic repository is required to:
    (1) Limit radiological exposures to the reasonably maximally 
exposed individual, as specified at Sec. 63.113(b);
    (2) Limit releases of radionuclides to the accessible environment 
to protect ground water, as specified at Sec. 63.113(c); and
    (3) Limit radiological exposures to the reasonably maximally 
exposed individual in the event of human intrusion, as specified at 
Sec. 63.113(d).
    (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 one or 
more aspects of the geologic setting will be capable of contributing to 
the isolation of radioactive waste and thus be a barrier important to 
waste isolation. 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 and natural analogs, 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. The performance 
assessment provides an evaluation of the repository performance based 
on credible models and parameters including the consideration of 
uncertainty in the behavior of the repository system. Thus the 
performance assessment results reflect the capability of each of the 
barriers to cope with a variety of challenges (e.g., combinations of 
parameters leading to less favorable performance for individual 
barriers and combinations of barriers). A description of each barrier's 
capability (e.g., retardation of radionuclides in the saturated zone, 
waste package lifetime, matrix diffusion in the unsaturated zone), as 
reflected in the performance assessment, provides an understanding of 
how the natural barriers and the engineered barrier system work in 
combination to enhance the resiliency of the geologic repository. The 
Commission believes that this understanding can increase confidence 
that the postclosure performance objectives specified at Sec. 63.113(b) 
and (c) will be achieved and that DOE's design includes a system of 
multiple barriers.
    (i) Reference biosphere and reasonably maximally exposed 
individual. 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 the reasonably 
maximally exposed individual. The environment inhabited by the 
reasonably maximally exposed individual, along with associated human 
exposure pathways and parameters, make up the reference biosphere, as 
described in Sec. 63.305. The reasonably maximally exposed individual, 
as a hypothetical person living in a community with characteristics of 
the Town of Amargosa Valley, is a representative person using water 
with average concentrations of radionuclides as described at 
Sec. 63.312. The reasonably maximally exposed individual 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 reasonably maximally 
exposed individual are to be based on current human behavior and 
biospheric conditions in the region, as described in Sec. 63.305 and 
Sec. 63.312.
    (j) Performance assessment. Demonstrating compliance with the 
postclosure performance objective specified at Sec. 63.113(b) requires 
a performance assessment to quantitatively estimate radiological 
exposures to the reasonably maximally exposed individual at any time 
during the compliance period. 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 radiological exposures 
to the reasonably maximally exposed individual. 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 (event classes or scenario classes) that are 
very unlikely (less than one chance in 10,000 over 10,000 years) can be 
excluded from the analysis. An event class consists of all possible 
specific initiating events that are caused by a common natural process 
(e.g., the event class for seismicity includes the range of credible 
earthquakes for the Yucca Mountain site). Radiological exposures to the 
reasonably maximally exposed individual are estimated using the 
selected features, events, and processes, and incorporating the 
probability that the estimated exposures will occur. Additionally, 
performance assessment methods are appropriate for use in demonstrating 
compliance with the postclosure performance objectives for ground-water 
protection and human intrusion, and are subject to the requirements for 
performance assessments specified at Sec. 63.114 and applicable 
criteria in Subpart L (e.g., criteria for evaluating compliance with 
ground-water protection and individual protection standards).
    (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. However, because it is not possible to make 
scientifically sound forecasts of the long-term reliability of 
institutional controls, it is not appropriate to include consideration 
of human intrusion into a fully risk-based performance assessment for 
purposes of evaluating the ability of

[[Page 55806]]

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 human intrusion event. Although the consequences of an 
assumed intrusion event would be a separate analysis, the analysis is 
similar to the performance assessment required by Sec. 63.113(b) but 
subject to specific requirements for evaluation of human intrusion 
specified at Secs. 63.321, 63.322 and 63.342 of subpart L of this part.
    (m) Performance confirmation. A performance confirmation program 
will be conducted to evaluate the adequacy of assumptions, data, and 
analyses that led to the findings that permitted construction of the 
repository and subsequent emplacement of the wastes. Key geotechnical 
and design parameters, including any interactions between natural and 
engineered systems and components, will be monitored throughout site 
characterization, construction, emplacement, and operation to identify 
any significant changes in the conditions assumed in the license 
application that may affect compliance with the performance objectives 
specified at Sec. 63.113(b) and (c).
    (n) Ground-Water Protection. Separate ground-water protection 
standards are designed to protect the ground water resources in the 
vicinity of Yucca Mountain. These standards, specified at Sec. 63.331, 
require the estimation of ground water concentrations in the 
representative volume of water. Depending on the radionuclide, the 
estimated concentrations must either be below a specified concentration 
or result in an annual, drinking water dose to the whole body or any 
organ of no greater than 0.04 mSv (4 mrem). Although the estimation of 
radionuclide concentrations in the representative volume would be a 
separate analysis, the analysis is similar to the performance 
assessment required by Sec. 63.113(b) but subject to specific 
requirements for evaluation of ground-water protection specified at 
Secs. 63.331, 63.332 and 63.342 of subpart L of this part.

Preclosure 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 must meet the 
requirements of part 20 of this chapter.
    (2) During normal operations, and for Category 1 event sequences, 
the annual TEDE (hereafter referred to as ``dose'') to any real member 
of the public located beyond the boundary of the site may not exceed 
the preclosure standard specified at Sec. 63.204.
    (b) Numerical guides for design objectives.
    (1) The geologic repository operations area must be designed so 
that, taking into consideration Category 1 event sequences and until 
permanent closure has been completed, the aggregate radiation exposures 
and the aggregate radiation levels in both restricted and unrestricted 
areas, and the aggregate 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 must be designed so 
that, taking into consideration any single Category 2 event sequence 
and until permanent closure has been completed, no individual located 
on, or beyond, any point on the boundary of the site will receive, as a 
result of the single Category 2 event sequence, 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 may 
not exceed 0.15 Sv (15 rem), and the shallow dose equivalent to skin 
may not exceed 0.5 Sv (50 rem).
    (c) Preclosure safety analysis. A preclosure safety analysis of the 
geologic repository operations area that meets the requirements 
specified at Sec. 63.112 must be performed. This analysis must 
demonstrate 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 must 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 must 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 must 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 may 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 paragraph (e) of this section, 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.

Preclosure Safety Analysis


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

    The preclosure safety analysis of the geologic repository 
operations area must 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 
event sequences;
    (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 structures, systems, and 
components to identify those that are important to safety. This 
analysis identifies and describes the controls that are relied on to 
limit or prevent potential event sequences or mitigate their

[[Page 55807]]

consequences. This analysis also identifies measures taken to ensure 
the availability of safety systems. The analysis required in this 
paragraph must 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 areas;
    (6) Means to prevent and 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 event sequences;
    (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 design criteria and the requirements 
specified at Sec. 63.111(a) and (b); and
    (2) The design bases and their relation to the design criteria.

Postclosure Performance Objectives


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

    (a) The geologic repository must include multiple barriers, 
consisting of both natural barriers and an engineered barrier system.
    (b) The engineered barrier system must be designed so that, working 
in combination with natural barriers, radiological exposures to the 
reasonably maximally exposed individual are within the limits specified 
at Sec. 63.311 of subpart L of this part. Compliance with this 
paragraph must be demonstrated through a performance assessment that 
meets the requirements specified at Sec. 63.114 of this subpart, and 
Secs. 63.303, 63.305, 63.312 and 63.342 of Subpart L of this part.
    (c) The engineered barrier system must be designed so that, working 
in combination with natural barriers, releases of radionuclides into 
the accessible environment are within the limits specified at 
Sec. 63.331 of subpart L of this part. Compliance with this paragraph 
must be demonstrated through a performance assessment that meets the 
requirements specified at Sec. 63.114 of this subpart and Secs. 63.303, 
63.332 and 63.342 of subpart L of this part.
    (d) The ability of the geologic repository to limit radiological 
exposures to the reasonably maximally exposed individual, in the event 
of human intrusion into the engineered barrier system, must be 
demonstrated through an analysis that meets the requirements at 
Secs. 63.321 and 63.322 of subpart L of this part. Estimating 
radiological exposures to the reasonably maximally exposed individual 
requires a performance assessment that meets the requirements specified 
at Sec. 63.114 of this subpart, and Secs. 63.303, 63.305, 63.312 and 
63.342 of subpart L of this part.

Postclosure Performance Assessment


Sec. 63.114  Requirements for performance assessment.

    Any performance assessment used to demonstrate compliance with 
Sec. 63.113 must:
    (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 for 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 in the performance 
assessment. Specific features, events, and processes must be evaluated 
in detail if the magnitude and time of the resulting radiological 
exposures to the reasonably maximally exposed individual, or 
radionuclide releases to the accessible environment, 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 radiological exposures to the reasonably maximally exposed 
individual, or radionuclide releases to the accessible environment, 
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).


Sec. 63.115  Requirements for multiple barriers.

    Demonstration of compliance with Sec. 63.113(a) must:
    (a) Identify those design features of the engineered barrier 
system, and natural features of the geologic setting, that are 
considered barriers important to waste isolation.
    (b) Describe the capability of barriers, identified as important to 
waste isolation, to isolate waste, taking into account uncertainties in 
characterizing and modeling the behavior of the barriers.
    (c) Provide the technical basis for the description of the 
capability of barriers, identified as important to waste isolation, to 
isolate waste. The technical basis for each barrier's capability shall 
be based on and consistent with the technical basis for the performance 
assessments used to demonstrate compliance with Sec. 63.113(b) and (c).

[[Page 55808]]

Land Ownership and Control


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

    (a) Ownership of land.
    (1) The geologic repository operations area must 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 must 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 for permanent closure. Appropriate controls 
must be established outside of the geologic repository operations area. 
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) Additional controls through permanent closure. Appropriate 
controls must be established outside the geologic repository operations 
area. DOE shall exercise any jurisdiction or control of activities 
necessary to ensure the requirements at Sec. 63.111(a) and (b) are met. 
Control includes the authority to exclude members of the public, if 
necessary.
    (d) Water rights.
    (1) DOE shall also have obtained such water rights as may 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 must 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) Natural 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 must have been started during site 
characterization, and it will continue until permanent closure.
    (c) The program must 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 must 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 
must be conducted to ensure that geotechnical and design parameters are 
confirmed and to ensure that appropriate action is taken to inform the 
Commission of design changes needed to accommodate actual field 
conditions encountered.
    (b) Subsurface conditions must be monitored and evaluated against 
design assumptions.
    (c) Specific geotechnical and design parameters to be measured or 
observed, including any interactions between natural and engineered 
systems and components, must be identified in the performance 
confirmation plan.
    (d) These measurements and observations must 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 must 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 must 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 testing of engineered systems and components used in the 
design, such as, for example, borehole and shaft seals, backfill, and 
drip shields, as well as the thermal interaction effects of the waste 
packages, backfill, drip shields, rock, and unsaturated zone and 
saturated zone water, must be conducted.
    (b) The testing must be initiated as early as practicable.
    (c) If backfill is included in the repository design, a test must 
be conducted to evaluate the effectiveness of backfill placement and 
compaction procedures against design requirements before permanent 
backfill placement is begun.
    (d) Tests must be conducted to evaluate 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 must be established at the geologic repository 
operations area for monitoring the condition of the waste packages. 
Waste packages chosen for the program must 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 must be representative of the 
environment in which the wastes are to be emplaced.
    (c) The waste package monitoring program must 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 must be duplicated in the laboratory experiments.
    (d) The waste package monitoring program must 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 structures, systems, or components will 
perform satisfactorily in service. Quality assurance includes

[[Page 55809]]

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  Quality assurance criteria.

    (a) Introduction and Applicability. DOE is required by 
Sec. 63.21(c)(20) to include in its safety analysis report a 
description of the quality assurance program to be applied to all 
structures, systems, and components important to safety, to design and 
characterization of barriers important to waste isolation, and to 
related activities. These activities include: site characterization; 
acquisition, control, and analyses of samples and data; tests and 
experiments; scientific studies; facility and equipment design and 
construction; facility operation; performance confirmation; permanent 
closure; and decontamination and dismantling of surface facilities. The 
description must indicate how the applicable quality assurance 
requirements will be satisfied. DOE shall include information 
pertaining to the managerial and administrative controls to be used to 
ensure safe operation in its safety analysis report. High-level waste 
repositories include structures, systems, and components that prevent 
or mitigate the consequences of postulated event sequences or that are 
important to waste isolation capabilities that could cause undue risk 
to the health and safety of the public. The pertinent requirements of 
this subpart apply to all activities that are important to waste 
isolation and important to safety functions of those structures, 
systems, and components. These activities include designing, 
purchasing, fabricating, handling, shipping, storing, cleaning, 
erecting, installing, inspecting, testing, operating, maintaining, 
repairing, modifying, site characterization, performance confirmation, 
permanent closure, decontamination, and dismantling of surface 
facilities.
    (b) Organization. DOE shall establish and execute a quality 
assurance program. DOE may delegate to others, such as contractors, 
agents, or consultants, the work of establishing and executing the 
quality assurance program, or any part of it, but DOE retains 
responsibility for it.
    (1) The authority and duties of persons and organizations 
performing activities affecting the functions of structures, systems, 
and components that are important to waste isolation and important to 
safety must be clearly established and delineated in writing. These 
activities include both the performing functions of attaining quality 
objectives and the quality assurance functions. The quality assurance 
functions are those of:
    (i) Assuring that an appropriate quality assurance program is 
established and effectively executed; and
    (ii) Verifying that activities important to waste isolation and 
important to safety functions have been correctly performed by 
checking, auditing, and inspection of structures, systems, and 
components.
    (2) The persons and organizations performing quality assurance 
functions shall have sufficient authority and organizational freedom to 
identify quality problems; to initiate, recommend, or provide 
solutions; and to verify implementation of solutions. The persons and 
organizations performing quality assurance functions shall report to a 
management level so that the required authority and organizational 
freedom, including sufficient independence from cost and schedule when 
opposed to safety considerations, are provided.
    (3) Because of the many variables involved, such as the number of 
personnel, the type of activity being performed, and the location or 
locations where activities are performed, the organizational structure 
for executing the quality assurance program may take various forms 
provided that the persons and organizations assigned the quality 
assurance functions have this required authority and organizational 
freedom. Irrespective of the organizational structure, the 
individual(s) assigned the responsibility for assuring effective 
execution of any portion of the quality assurance program at any 
location where activities subject to 10 CFR part 63 are being performed 
must have direct access to the levels of management as may be necessary 
to perform this function.
    (c) Quality assurance program. DOE shall establish a quality 
assurance program that complies with the requirements of this subpart 
at the earliest practicable time, consistent with the schedule for 
accomplishing the activities. This program must be documented by 
written policies, procedures, or instructions and must be carried out 
throughout facility life in accordance with those policies, procedures, 
or instructions.
    (1) DOE shall identify the structures, systems, and components to 
be covered by the quality assurance program and the major organizations 
participating in the program, together with the designated functions of 
these organizations. The quality assurance program must control 
activities affecting the quality of the identified structures, systems, 
and components, to an extent consistent with their importance to 
safety.
    (2) Activities affecting quality must be accomplished under 
suitably controlled conditions. Controlled conditions include the use 
of appropriate equipment; suitable environmental conditions for 
accomplishing the activity, such as adequate cleanness; and assurance 
that all prerequisites for the given activity have been satisfied.
    (3) The program must take into account the need for special 
controls, processes, test equipment, tools, and skills to attain the 
required quality, and the need for verification of quality by 
inspection and test. The program must provide for indoctrination and 
training of personnel performing activities affecting quality as 
necessary to assure that suitable proficiency is achieved and 
maintained.
    (4) DOE shall regularly review the status and adequacy of the 
quality assurance program. Management of other organizations 
participating in the quality assurance program shall regularly review 
the status and adequacy of that part of the quality assurance program 
which they are executing.
    (d) Design control. (1) DOE shall establish measures to assure that 
applicable regulatory requirements and the design basis, as defined in 
Sec. 63.2 and as specified in the license application, for those 
structures, systems, and components to which this subpart applies, are 
correctly translated into specifications, drawings, procedures, and 
instructions. These measures must assure that appropriate quality 
standards are specified and included in design documents and that 
deviations from such standards are controlled. Measures must also be 
established for the selection and review for suitability of application 
of materials, parts, equipment, and processes that are important to 
waste isolation and important to safety functions of the structures, 
systems and components.
    (2) DOE shall establish measures to identify and control design 
interfaces and for coordination among participating design 
organizations. These measures must include the establishment of 
procedures among participating design organizations for the review, 
approval, release, distribution, and revision of documents involving 
design interfaces.
    (i) The design control measures must provide for verifying or 
checking the adequacy of design, such as by the

[[Page 55810]]

performance of design reviews, by the use of alternate or simplified 
calculational methods, or by the performance of a suitable testing 
program. The verifying or checking process must be performed by 
individuals or groups other than those who performed the original 
design. These individuals may be from the same organization. If a test 
program is used to verify the adequacy of a specific design feature in 
lieu of other verifying or checking processes, it must include suitable 
qualifications testing of a prototype unit under the most adverse 
design conditions. Design control measures must be applied to items 
such as: criticality physics, stress, thermal, hydraulic, and 
preclosure and postclosure analyses; compatibility of materials; 
accessibility for inservice inspection, maintenance and repair; and 
delineation of acceptance criteria for inspections and tests.
    (ii) Design changes, including field changes, must be subject to 
design control measures commensurate with those applied to the original 
design and be approved by the organization that performed the original 
design unless the applicant designates another responsible 
organization.
    (e) Procurement document control. DOE shall establish measures to 
assure that applicable regulatory requirements, design bases, and other 
requirements necessary to assure adequate quality are suitably included 
or referenced in the documents for procurement of material, equipment, 
and services, whether purchased by the licensee or applicant or by its 
contractors or subcontractors. To the extent necessary, procurement 
documents must require contractors or subcontractors to provide a 
quality assurance program consistent with the pertinent provisions of 
this section.
    (f) Instructions, procedures, and drawings. Activities affecting 
quality must be prescribed by documented instructions, procedures, or 
drawings of a type appropriate to the circumstances and must be 
accomplished in accordance with these instructions, procedures, or 
drawings. Instructions, procedures, or drawings must include 
appropriate quantitative or qualitative acceptance criteria for 
determining that important activities have been satisfactorily 
accomplished.
    (g) Document control. DOE shall establish measures to control the 
issuance of documents, such as instructions, procedures, and drawings, 
including changes to them that prescribe all activities affecting 
quality. These measures must assure that documents, including changes, 
are reviewed for adequacy and approved for release by authorized 
personnel and are distributed to and used at the location where the 
prescribed activity is performed. Changes to documents must be reviewed 
and approved by the same organizations that performed the original 
review and approval unless the applicant designates another responsible 
organization.
    (h) Control of purchased material, equipment, and services. DOE 
shall establish measures to assure that purchased material, equipment, 
and services, whether purchased directly or through contractors and 
subcontractors, conform to the procurement documents.
    (1) These measures must include appropriate provisions for source 
evaluation and selection, objective evidence of quality furnished by 
the contractor or subcontractor, inspection at the contractor or 
subcontractor source, and examination of products upon delivery.
    (2) Documentary evidence that material and equipment conform to the 
procurement requirements must be available at the high-level waste 
repository site before the material and equipment are installed or 
used. This documentary evidence must be retained at the high-level 
waste repository site and be sufficient to identify the specific 
requirements, such as codes, standards, or specifications, met by the 
purchased material and equipment.
    (3) The effectiveness of the control of quality by contractors and 
subcontractors must be assessed by the licensee or applicant or 
designee at intervals consistent with the importance, complexity, and 
quantity of the product or services.
    (i) Identification and control of materials, parts, and components. 
Measures must be established for the identification and control of 
materials, parts, and components, including partially fabricated 
assemblies. These measures must assure that identification of the item 
is maintained by heat number, part number, serial number, or other 
appropriate means, either on the item or on records traceable to the 
item, as required throughout fabrication, erection, installation, and 
use of the item. These identification and control measures must be 
designed to prevent the use of incorrect or defective material, parts, 
and components.
    (j) Control of special processes. DOE shall establish measures to 
assure that special processes, including welding, heat treating, and 
nondestructive testing, are controlled and accomplished by qualified 
personnel using qualified procedures in accordance with applicable 
codes, standards, specifications, criteria, and other special 
requirements.
    (k) Inspection. DOE shall establish and execute a program for 
inspection of activities affecting quality to verify conformance with 
the documented instructions, procedures, and drawings for accomplishing 
the activity. The inspection must be performed by individuals other 
than those who performed the activity being inspected.
    (1) Examinations, measurements, or tests of material or products 
processed must be performed for each work operation where necessary to 
assure quality. If inspection of processed material or products is 
impossible or disadvantageous, indirect control by monitoring 
processing methods, equipment, and personnel must be provided. Both 
inspection and process monitoring must be provided when control is 
inadequate without both.
    (2) If mandatory inspection hold points that require witnessing or 
inspecting by the applicant's designated representative and beyond 
which work may not proceed without the consent of its designated 
representative are required, the specific hold points must be indicated 
in appropriate documents.
    (l) Test control. DOE shall establish a test program to assure that 
all testing required to demonstrate that structures, systems, and 
components important to safety will perform satisfactorily in service 
is identified and performed in accordance with written test procedures 
which incorporate the requirements and acceptance limits contained in 
applicable design documents.
    (1) The test program must include, as appropriate, proof tests 
prior to installation, preoperational tests, and operational tests 
during repository operation, of structures, systems, and components.
    (2) Test procedures must include provisions for assuring that all 
prerequisites for the given test have been met, that adequate test 
instrumentation is available and used, and that the test is performed 
under suitable environmental conditions.
    (3) Test results must be documented and evaluated to assure that 
test requirements have been satisfied.
    (m) Control of measuring and test equipment. DOE shall establish 
measures to assure that tools, gages, instruments, and other measuring 
and testing devices used in activities affecting quality are properly 
controlled, calibrated, and adjusted at specified periods to maintain 
accuracy within necessary limits.
    (n) Handling, storage, and shipping. DOE shall establish measures 
to control the handling, storage, shipping, cleaning

[[Page 55811]]

and preservation of material and equipment in accordance with work and 
inspection instructions to prevent damage or deterioration. When 
necessary for particular products, special protective environments, 
such as inert gas atmosphere, specific moisture content levels, and 
temperature levels, must be specified and provided.
    (o) Inspection, test, and operating status. DOE shall establish 
measures to indicate the status of inspections and tests performed on 
individual items of the high-level waste repository by markings such as 
stamps, tags, labels, routing cards, or other suitable means. These 
measures must provide for the identification of items that have 
satisfactorily passed required inspections and tests, where necessary 
to preclude inadvertent bypassing of such inspections and tests. 
Measures must also be established for indicating the operating status 
of structures, systems, and components of the high-level waste 
repository, such as by tagging valves and switches, to prevent 
inadvertent operation.
    (p) Nonconforming materials, parts, or components. DOE shall 
establish measures to control materials, parts, or components which do 
not conform to requirements in order to prevent their inadvertent use 
or installation. These measures must include, as appropriate, 
procedures for identification, documentation, segregation, disposition, 
and notification to affected organizations. Nonconforming items must be 
reviewed and accepted, rejected, repaired or reworked in accordance 
with documented procedures.
    (q) Corrective action. DOE shall establish measures to assure that 
conditions adverse to quality, such as failures, malfunctions, 
deficiencies, deviations, defective material and equipment, and 
nonconformances are promptly identified and corrected. If significant 
conditions are adverse to quality, the measures must assure that the 
cause of the condition is determined and corrective action taken to 
preclude repetition. The identification of the significant condition 
adverse to quality, the cause of the condition, and the corrective 
action taken must be documented and reported to appropriate levels of 
management.
    (r) Quality assurance records. DOE shall maintain sufficient 
records to furnish evidence of activities affecting quality.
    (1) The records must include at least the following: Operating logs 
and the results of reviews, inspections, tests, audits, monitoring of 
work performance, and materials analyses.
    (2) The records must also include closely-related data such as 
qualifications of personnel, procedures, and equipment.
    (3) Inspection and test records must, at a minimum, identify the 
inspector or data recorder, the type of observation, the results, the 
acceptability, and the action taken in connection with any deficiencies 
noted.
    (4) Records must be identifiable and retrievable. Consistent with 
applicable regulatory requirements, the applicant shall establish 
requirements concerning record retention, such as duration, location, 
and assigned responsibility.
    (s) Audits. DOE shall carry out a comprehensive system of planned 
and periodic audits to verify compliance with all aspects of the 
quality assurance program and to determine the effectiveness of the 
program. The audits must be performed in accordance with the written 
procedures or check lists by appropriately trained personnel not having 
direct responsibilities in the areas being audited. Audit results must 
be documented and reviewed by management having responsibility in the 
area audited. Followup action, including reaudit of deficient areas, 
must be taken where indicated.


Sec. 63.143  Implementation.

    DOE shall implement a quality assurance program based on the 
criteria required by Sec. 63.142.


Sec. 63.144  Quality assurance program change.

    Changes to DOE's NRC-approved Safety Analysis Report quality 
assurance program description are processed as follows:
    (a) DOE may change a previously accepted quality assurance program 
description included or referenced in the Safety Analysis Report 
without prior NRC approval, if the change does not reduce the 
commitments in the program description previously accepted by the NRC. 
Changes to the quality assurance program description that do not reduce 
the commitments must be submitted every 24 months, in accordance with 
paragraph (b)(1) of this section. In addition to quality assurance 
program changes involving administrative improvements and 
clarifications, spelling corrections, punctuation, or editorial items, 
the following changes are not considered reductions in commitment:
    (1) The use of a quality assurance standard approved by the NRC 
which is more recent than the quality assurance standard in DOE's 
current quality assurance program at the time of the change;
    (2) The use of generic organizational position titles that clearly 
denote the position function, supplemented as necessary by descriptive 
text, rather than specific titles;
    (3) The use of generic organizational charts to indicate functional 
relationships, authorities, and responsibilities, or alternatively, the 
use of descriptive text;
    (4) The elimination of quality assurance program information that 
duplicates language in quality assurance regulatory guides and quality 
assurance standards to which the licensee is committed; and
    (5) Organizational revisions that ensure that persons and 
organizations performing quality assurance functions continue to have 
the requisite authority and organizational freedom, including 
sufficient independence from cost and schedule when opposed to safety 
considerations.
    (b) DOE shall submit changes made to the NRC-accepted Safety 
Analysis Report quality assurance program description that do reduce 
the commitments to the NRC and receive NRC approval prior to 
implementation, as follows:
    (1) The signed original must be submitted to the Nuclear Regulatory 
Commission, Document Control Desk, Washington, DC 20555, one copy to 
the Director, Office of Nuclear Material and Safeguards, U. S. Nuclear 
Regulatory Commission, Washington, DC 20555, and one copy to the 
appropriate NRC Resident Inspector if one has been assigned to the site 
or facility.
    (2) The submittal of a change to the Safety Analysis Report quality 
assurance program description must include all pages affected by that 
change and must be accompanied by a forwarding letter identifying the 
change, the reason for the change, and the basis for concluding that 
the revised program incorporating the change continues to describe how 
the requirements of Sec. 63.142 will be satisfied and continues to 
satisfy the criteria of Sec. 63.142 and the Safety Analysis Report 
quality assurance program description previously accepted by the NRC 
(the letter need not provide the basis for changes that correct 
spelling, punctuation, or editorial items).
    (3) DOE shall maintain records of quality assurance program changes 
that do reduce commitments.

Subpart H--Training and Certification of Personnel


Sec. 63.151  General requirements.

    Operations of systems and components that have been identified as

[[Page 55812]]

important to safety in the Safety Analysis Report and in the license 
must 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.


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 may 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 the 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 decontamination and dismantlement of surface 
facilities. The emergency plan must 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 under 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 under 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: Secs. 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, 63.143, 63.153, 63.161, 63.171, 63.172, 63.201, 
63.202, 63.203, 63.204, 63.301, 63.302, 63.303, 63.304, 63.305, 63.311, 
63.312, 63.321, 63.322, 63.331, 63.332, 63.341, and 63.342.

Subpart K--Preclosure Public Health and Environmental Standards


Sec. 63.201  Purpose and scope.

    This subpart covers the storage of radioactive material by DOE in 
the Yucca Mountain repository and on the Yucca Mountain site. For the 
purposes of demonstrating compliance with this subpart, to the extent 
there may be any conflict with the requirements specified in this 
subpart and the requirements contained in Subparts A-J of this 
regulation, including definitions, the requirements in this subpart 
shall take precedence.


Sec. 63.202  Definitions for Subpart K.

    General environment means everywhere outside the Yucca Mountain 
site, the Nellis Air Force Range, and the Nevada Test Site.
    Member of the public means anyone who is not a radiation worker for 
purposes of worker protection.
    Radioactive material means matter composed of or containing 
radionuclides subject to the Atomic Energy Act of 1954, as amended (42 
U.S.C. sec. 2014 et seq.). Radioactive material includes, but is not 
limited to, high-level radioactive waste and spent nuclear fuel.
    Spent nuclear fuel means fuel that has been withdrawn from a 
nuclear reactor following irradiation, the constituent elements of 
which have not been separated by reprocessing.
    Storage means retention (and any associated activity, operation, or 
process necessary to carry out successful retention) of radioactive 
material with the intent or capability to readily access or retrieve 
such material.
    Yucca Mountain repository means the excavated portion of the 
facility constructed underground within the Yucca Mountain site.
    Yucca Mountain site means:
    (1) The site recommended by the Secretary of DOE to the President 
under section 112(b)(1)(B) of the Nuclear Waste Policy Act of 1982 (42 
U.S.C. 10132(b)(1)(B)) on May 27, 1986; or
    (2) The area under the control of DOE for the use of Yucca Mountain 
activities at the time of licensing, if the site designated under the 
Nuclear Waste Policy Act is amended by Congress prior to the time of 
licensing.


Sec. 63.203  Implementation of Subpart K.

    DOE must demonstrate that normal operations at the Yucca Mountain 
site will and do occur in compliance with this subpart before the 
Commission grants or continues a license for DOE to receive and possess 
radioactive material within the Yucca Mountain site.


Sec. 63.204  Preclosure standard.

    DOE must ensure that no member of the public in the general 
environment receives more than an annual dose of 0.15 mSv (15 mrem) 
from the combination of:
    (a) Management and storage (as defined in 40 CFR 191.2) of 
radioactive material that:
    (1) Is subject to 40 CFR 191.3(a); and
    (2) Occurs outside of the Yucca Mountain repository but within the 
Yucca Mountain site; and
    (b) Storage (as defined in Sec. 63.202) of radioactive material 
inside the Yucca Mountain repository.

[[Page 55813]]

Subpart L--Postclosure Public Health and Environmental Standards


Sec. 63.301  Purpose and scope.

    This subpart covers the disposal of radioactive material in the 
Yucca Mountain repository by DOE. For the purposes of demonstrating 
compliance with this subpart, to the extent that there may be any 
conflict with the requirements specified in this subpart and the 
requirements contained in Subparts A-J of this part, including 
definitions, the requirements in this subpart shall take precedence.


Sec. 63.302  Definitions for Subpart L.

    All definitions in subpart K of this part, and the following:
    Accessible environment means any point outside of the controlled 
area, including:
    (1) The atmosphere (including the atmosphere above the surface area 
of the controlled area);
    (2) Land surfaces;
    (3) Surface waters;
    (4) Oceans; and
    (5) The lithosphere.
    Aquifer means a water-bearing underground geological formation, 
group of formations, or part of a formation (excluding perched water 
bodies) that can yield a significant amount of ground water to a well 
or spring.
    Controlled area means:
    (1) The surface area, identified by passive institutional controls, 
that encompasses no more than 300 square kilometers. It must not extend 
farther:
    (i) South than 36 deg.40'13.6661" North latitude, in the 
predominant direction of ground-water flow; and
    (ii) Than five kilometers from the repository footprint in any 
other direction; and
    (2) The subsurface underlying the surface area.
    Disposal means the emplacement of radioactive material into the 
Yucca Mountain disposal system with the intent of isolating it for as 
long as reasonably possible and with no intent of recovery, whether or 
not the design of the disposal system permits the ready recovery of the 
material. Disposal of radioactive material in the Yucca Mountain 
disposal system begins when all of the ramps and other openings into 
the Yucca Mountain repository are sealed.
    Ground water means water that is below the land surface and in a 
saturated zone.
    Human intrusion means breaching of any portion of the Yucca 
Mountain disposal system, within the repository footprint, by any human 
activity.
    Passive institutional controls means:
    (1) Markers, as permanent as practicable, placed on the Earth's 
surface;
    (2) Public records and archives;
    (3) Government ownership and regulations regarding land or resource 
use; and
    (4) Other reasonable methods of preserving knowledge about the 
location, design, and contents of the Yucca Mountain disposal system.
    Peak dose means the highest annual dose projected to be received by 
the reasonably maximally exposed individual.
    Period of geologic stability means the time during which the 
variability of geologic characteristics and their future behavior in 
and around the Yucca Mountain site can be bounded, that is, they can be 
projected within a reasonable range of possibilities.
    Plume of contamination means that volume of ground water in the 
predominant direction of ground-water flow that contains radioactive 
contamination from releases from the Yucca Mountain repository. It does 
not include releases from any other potential sources on or near the 
Nevada Test Site.
    Repository footprint means the outline of the outermost locations 
of where the waste is emplaced in the Yucca Mountain repository.
    Slice of the plume means a cross-section of the plume of 
contamination with sufficient thickness parallel to the prevalent 
direction of flow of the plume that it contains the representative 
volume.
    Total dissolved solids means the total dissolved (filterable) 
solids in water as determined by use of the method specified in 40 CFR 
part 136.
    Undisturbed performance means that human intrusion or the 
occurrence of unlikely natural features, events, and processes do not 
disturb the disposal system.
    Undisturbed Yucca Mountain disposal system means that the Yucca 
Mountain disposal system is not affected by human intrusion.
    Waste means any radioactive material emplaced for disposal into the 
Yucca Mountain repository.
    Well-capture zone means the volume from which a well pumping at a 
defined rate is withdrawing water from an aquifer. The dimensions of 
the well-capture zone are determined by the pumping rate in combination 
with aquifer characteristics assumed for calculations, such as 
hydraulic conductivity, gradient, and the screened interval.
    Yucca Mountain disposal system means the combination of underground 
engineered and natural barriers within the controlled area that 
prevents or substantially reduces releases from the waste.


Sec. 63.303  Implementation of Subpart L.

    DOE must demonstrate that there is a reasonable expectation of 
compliance with this subpart before a license may be issued. In the 
case of the specific numerical requirements in Sec. 63.311 of this 
subpart, and if performance assessment is used to demonstrate 
compliance with the specific numerical requirements in Secs. 63.321 and 
63.331 of this subpart, compliance is based upon the mean of the 
distribution of projected doses of DOE's performance assessments which 
project the performance of the Yucca Mountain disposal system for 
10,000 years after disposal.


Sec. 63.304  Reasonable expectation.

    Reasonable expectation means that the Commission is satisfied that 
compliance will be achieved based upon the full record before it. 
Characteristics of reasonable expectation include that it:
    (1) Requires less than absolute proof because absolute proof is 
impossible to attain for disposal due to the uncertainty of projecting 
long-term performance;
    (2) Accounts for the inherently greater uncertainties in making 
long-term projections of the performance of the Yucca Mountain disposal 
system;
    (3) Does not exclude important parameters from assessments and 
analyses simply because they are difficult to precisely quantify to a 
high degree of confidence; and
    (4) Focuses performance assessments and analyses on the full range 
of defensible and reasonable parameter distributions rather than only 
upon extreme physical situations and parameter values.


Sec. 63.305  Required characteristics of the reference biosphere.

    (a) Features, events, and processes that describe the reference 
biosphere must be consistent with present knowledge of the conditions 
in the region surrounding the Yucca Mountain site.
    (b) DOE should not project changes in society, the biosphere (other 
than climate), human biology, or increases or decreases of human 
knowledge or technology. In all analyses done to demonstrate compliance 
with this part, DOE must assume that all of those factors remain 
constant as they are at

[[Page 55814]]

the time of submission of the license application.
    (c) DOE must vary factors related to the geology, hydrology, and 
climate based upon cautious, but reasonable assumptions consistent with 
present knowledge of factors that could affect the Yucca Mountain 
disposal system over the next 10,000 years.
    (d) Biosphere pathways must be consistent with arid or semi-arid 
conditions.

Postclosure Individual Protection Standard


Sec. 63.311  Individual protection standard after permanent closure.

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


Sec. 63.312  Required characteristics of the reasonably maximally 
exposed individual.

    The reasonably maximally exposed individual is a hypothetical 
person who meets the following criteria:
    (a) Lives in the accessible environment above the highest 
concentration of radionuclides in the plume of contamination;
    (b) Has a diet and living style representative of the people who 
now reside in the Town of Amargosa Valley, Nevada. DOE must use 
projections based upon surveys of the people residing in the Town of 
Amargosa Valley, Nevada, to determine their current diets and living 
styles and use the mean values of these factors in the assessments 
conducted for Secs. 63.311 and 63.321;
    (c) Uses well water with average concentrations of radionuclides 
based on an annual water demand of 3000 acre-feet;
    (d) Drinks 2 liters of water per day from wells drilled into the 
ground water at the location specified in paragraph (a) of this 
section; and
    (e) Is an adult with metabolic and physiological considerations 
consistent with present knowledge of adults.

Human Intrusion Standard


Sec. 63.321  Individual protection standard for human intrusion.

    DOE must determine the earliest time after disposal that the waste 
package would degrade sufficiently that a human intrusion could occur 
without recognition by the drillers. DOE must:
    (a) Provide the analyses and its technical bases used to determine 
the time of occurrence of human intrusion (see Sec. 63.322) without 
recognition by the drillers.
    (b) If complete waste package penetration is projected to occur at 
or before 10,000 years after disposal:
    (1) Demonstrate that there is a reasonable expectation that the 
reasonably maximally exposed individual receives no more than an annual 
dose of 0.15 mSv (15 mrem) as a result of a human intrusion, at or 
before 10,000 years after disposal. The analysis must include all 
potential environmental pathways of radionuclide transport and exposure 
subject to the requirements at Sec. 63.322; and
    (2) If exposures to the reasonably maximally exposed individual 
occur more than 10,000 years after disposal, include the results of the 
analysis and its bases in the environmental impact statement for Yucca 
Mountain as an indicator of long-term disposal system performance.
    (c) Include the results of the analysis and its bases in the 
environmental impact statement for Yucca Mountain as an indicator of 
long-term disposal system performance, if the intrusion is not 
projected to occur before 10,000 years after disposal.


Sec. 63.322  Human intrusion scenario.

    For the purposes of the analysis of human intrusion, DOE must make 
the following assumptions:
    (a) There is a single human intrusion as a result of exploratory 
drilling for ground water;
    (b) The intruders drill a borehole directly through a degraded 
waste package into the uppermost aquifer underlying the Yucca Mountain 
repository;
    (c) The drillers use the common techniques and practices that are 
currently employed in exploratory drilling for ground water in the 
region surrounding Yucca Mountain;
    (d) Careful sealing of the borehole does not occur, instead natural 
degradation processes gradually modify the borehole;
    (e) No particulate waste material falls into the borehole;
    (f) The exposure scenario includes only those radionuclides 
transported to the saturated zone by water (e.g., water enters the 
waste package, releases radionuclides, and transports radionuclides by 
way of the borehole to the saturated zone); and
    (g) No releases are included which are caused by unlikely natural 
processes and events.

Ground-Water Protection Standards


Sec. 63.331  Separate standards for protection of ground water.

    DOE must demonstrate that there is a reasonable expectation that, 
for 10,000 years of undisturbed performance after disposal, releases of 
radionuclides from waste in the Yucca Mountain disposal system into the 
accessible environment will not cause the level of radioactivity in the 
representative volume of ground water to exceed the limits in the 
following Table 1:

     Table 1.--Limits on Radionuclides in the Representative Volume
------------------------------------------------------------------------
                                                           Is natural
    Radionuclide or type of              Limit             background
       radiation emitted                                    included?
------------------------------------------------------------------------
Combined radium-226 and radium- 5 picocuries per liter  Yes.
 228.
Gross alpha activity            15 picocuries per       Yes.
 (including radium-226 but       liter.
 excluding radon and uranium).
Combined beta and photon        0.04 mSv (4 mrem) per   No.
 emitting radionuclides.         year to the whole
                                 body or any organ,
                                 based on drinking 2
                                 liters of water per
                                 day from the
                                 representative volume.
------------------------------------------------------------------------

Sec. 63.332  Representative volume.

    (a) The representative volume is the volume of ground water that 
would be withdrawn annually from an aquifer containing less than 10,000 
milligrams of total dissolved solids per liter of water to supply a 
given water demand. DOE must project the concentration of radionuclides 
released from the Yucca Mountain disposal system that will be in the 
representative volume. DOE must use the projected concentrations to

[[Page 55815]]

demonstrate a reasonable expectation that the Yucca Mountain disposal 
system complies with Sec. 63.331. The DOE must make the following 
assumptions concerning the representative volume:
    (1) It includes the highest concentration level in the plume of 
contamination in the accessible environment;
    (2) Its position and dimensions in the aquifer are determined using 
average hydrologic characteristics which have cautious, but reasonable, 
values representative of the aquifers along the radionuclide migration 
path from the Yucca Mountain repository to the accessible environment 
as determined by site characterization; and
    (3) It contains 3,000 acre-feet of water (about 3,714,450,000 
liters or 977,486,000 gallons).
    (b) DOE must use one of two alternative methods for determining the 
dimensions of the representative volume. The DOE must propose its 
chosen method, and any underlying assumptions, to NRC for approval.
    (1) DOE may calculate the dimensions as a well-capture zone. If DOE 
uses this approach, it must assume that the:
    (i) Water supply well(s) has (have) characteristics consistent with 
public water supply wells in the Town of Amargosa Valley, Nevada, for 
example, well-bore size and length of the screened intervals;
    (ii) Screened interval(s) include(s) the highest concentration in 
the plume of contamination in the accessible environment; and
    (iii) Pumping rates and the placement of the well(s) must be set to 
produce an annual withdrawal equal to the representative volume and to 
tap the highest concentration within the plume of contamination.
    (2) DOE may calculate the dimensions as a slice of the plume. If 
DOE uses this approach, it must:
    (i) Propose, for approval, where the location of the edge of the 
plume of contamination occurs. For example, the place where the 
concentration of radionuclides reaches 0.1% of the level of the highest 
concentration in the accessible environment;
    (ii) Assume that the slice of the plume is perpendicular to the 
prevalent direction of flow of the aquifer; and
    (iii) Assume that the volume of ground water contained within the 
slice of the plume equals the representative volume.

Additional Provisions


Sec. 63.341  Projections of peak dose.

    To complement the results of Sec. 63.311, DOE must calculate the 
peak dose of the reasonably maximally exposed individual that would 
occur after 10,000 years following disposal but within the period of 
geologic stability. No regulatory standard applies to the results of 
this analysis; however, DOE must include the results and their bases in 
the environmental impact statement for Yucca Mountain as an indicator 
of long-term disposal system performance.


Sec. 63.342  Limits on performance assessments.

    DOE's performance assessments should not include consideration of 
very unlikely features, events, or processes, i.e., those that are 
estimated to have less than one chance in 10,000 of occurring within 
10,000 years of disposal. Unlikely features, events, and processes, or 
sequences of events and processes shall be excluded from the 
assessments for the human intrusion and ground water protection 
standards upon prior Commission approval for the probability limit used 
for unlikely features, events, and processes. In addition, DOE's 
performance assessments need not evaluate the impacts resulting from 
any features, events, and processes or sequences of events and 
processes with a higher chance of occurrence if the results of the 
performance assessments would not be changed significantly.


Sec. 63.343  Severability of individual protection and ground-water 
protection standards.

    The individual protection and ground-water protection standards are 
severable.

PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

    43. The authority citation for part 70 continues to read:


    Authority: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 
953, 954, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 
2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 
202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246, (42 
U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 Stat. 2835, as amended 
by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243).
    Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141, 
Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). 
Section 70.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 (42 U.S.C. 5851). Section 70.21(g) also issued under sec. 122, 
68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 
57d, Pub. L. 93-377, 88 Stat. 475 (42 U.S.C. 2077). Sections 70.36 
and 70.44 also issued under sec. 184, 68 Stat. 954, as amended (42 
U.S.C. 2234). Section 70.81 also issued under secs. 186, 187, 68 
Stat. 955 (42 U.S.C. 2236, 2237). Section 70.82 also issued under 
sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138).

    44. Section 70.17 is amended by revising paragraph (c) to read as 
follows:


Sec. 70.17  Specific exemptions.

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

PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF 
SPENT NUCLEAR FUEL AND HIGH-LEVEL RADIOACTIVE WASTE

    45. The authority citation for part 72 continues to read as 
follows:


    Authority: Secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 
184, 186, 189, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 
955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2071, 
2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233, 2234, 
2236, 2237, 2238, 2282); sec. 274, Pub. L. 86-373, 73 Stat. 688, as 
amended (42 U.S.C. 5841, 5842, 5846); Pub. L. 95-601, sec. 10, 92 
Stat. 2951 as amended by Pub. L. 102-486, sec. 7902, 106 Stat. 3123 
(42 U.S.C. 5851); sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 
4332); secs. 131, 132, 133, 135, 137, 141, Pub. L. 97-425, 96 Stat. 
2229, 2230, 2232, 2241, sec. 148, Pub. L. 100-203, 101 Stat. 1330-
235 (42 U.S.C. 10151, 10152, 10153, 10155, 10157, 10161, 10168).
    Section 72.44(g) also issued under secs. 142(b) and 148(c), (d), 
Pub. L. 100-203, 101 Stat. 1330-232, 1330-236 (42 U.S.C. 10162(b), 
10168(c), (d)). Section 72.46 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). Section 72.96(d) also issued under sec. 145(g), Pub. 
L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10165(g)). Subpart J also 
issued under secs. 2(2), 2(15), 2(19), 117(a), 141(h), Pub. L. 97-
425, 96 Stat. 2202, 2203, 2204, 2222, 2224, (42 U.S.C. 10101, 
10137(a), 10161(h)). Subparts K and L are also issued under sec. 
133, 98 Stat. 2230 (42 U.S.C. 10153) and sec. 218(a), 96 Stat. 2252 
(42 U.S.C. 10198).

    46. Section 72.44 is amended by revising paragraphs (g)(1) and 
(g)(3) to read as follows:


Sec. 72.44  License conditions.

* * * * *
    (g) * * *
    (1) Construction of the MRS may not begin until the Commission has 
authorized the construction of a repository under section 114(d) of 
NWPA (96 Stat. 2215, as amended by 101 Stat. 1330-230, 42 U.S.C. 10134 
(d)) and part 60 or 63 of this chapter;
* * * * *
    (3) The quantity of spent nuclear fuel or high-level radioactive 
waste at the site of the MRS at any one time may not

[[Page 55816]]

exceed 10,000 metric tons of heavy metal until a repository authorized 
under NWPA and part 60 or 63 of this chapter first accepts spent 
nuclear fuel or solidified high-level radioactive waste; and
* * * * *

PART 73--PHYSICAL PROTECTION OF PLANTS AND MATERIALS

    47. The authority citation for part 73 continues to read as 
follows:


    Authority: Secs. 53, 161, 68 Stat. 930, 948, as amended, sec. 
147, 94 Stat. 780 (42 U.S.C. 2073, 2167, 2201); sec. 201, as 
amended, 204, 88 Stat. 1242, as amended, 1245, sec. 1701, 106 Stat. 
2951, 2952, 2953 (42 U.S.C. 5841, 5844, 2297f).
    Section 73.1 also issued under secs. 135, 141, Pub. L. 97-425, 
96 Stat. 2232, 2241 (42 U.S.C, 10155, 10161). Section 73.37(f) also 
issued under sec. 301, Pub. L. 96-295, 94 Stat. 789 (42 U.S.C. 5841 
note). Section 73.57 is issued under sec. 606, Pub. L. 99-399, 100 
Stat. 876 (42 U.S.C. 2169).

    48. In Sec. 73.1, paragraph (b)(6) is revised to read as follows:


Sec. 73.1  Purpose and scope.

* * * * *
    (b) * * *
    (6) This part prescribes requirements for the physical protection 
of spent nuclear fuel and high-level radioactive waste stored in either 
an independent spent fuel storage installation (ISFSI) or a monitored 
retrievable storage (MRS) installation licensed under part 72 of this 
chapter, or stored at the geologic repository operations area licensed 
under part 60 or part 63 of this chapter.
* * * * *
    49. Section 73.51 is amended by revising paragraph (a) to read as 
follows:


Sec. 73.51  Requirements for the physical protection of stored spent 
nuclear fuel and high-level radioactive waste.

    (a) Applicability. Notwithstanding the provisions of Secs. 73.20, 
73.50, or 73.67, the physical protection requirements of this section 
apply to each licensee that stores spent nuclear fuel and high-level 
radioactive waste pursuant to paragraphs (a)(1)(i), (ii), and (2) of 
this section. This includes--
    (1) Spent nuclear fuel and high-level radioactive waste stored 
under a specific license issued pursuant to part 72 of this chapter:
    (i) At an independent spent fuel storage installation (ISFSI) or
    (ii) At a monitored retrievable storage (MRS) installation; or
    (2) Spent nuclear fuel and high-level radioactive waste at a 
geologic repository operations area (GROA) licensed pursuant to part 60 
or 63 of this chapter;
* * * * *

PART 75--SAFEGUARDS ON NUCLEAR MATERIAL--IMPLEMENTATION OF US/IAEA 
AGREEMENT

    50. The authority citation for part 75 continues to read as 
follows:


    Authority: Secs. 53, 63, 103, 104, 122, 161, 68 Stat. 930, 932, 
936, 937, 939, 948, as amended (42 U.S.C. 2073, 2093, 2133, 2134, 
2152, 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
    Section 75.4 also issued under secs. 135, 141, Pub. L. 97-425, 
96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).

    51. Section 75.4 is amended by revising paragraph (k)(5) to read as 
follows:


Sec. 75.4  Definitions.

* * * * *
    (k) * * *
    (5) Any location where the possession of more than 1 effective 
kilogram of nuclear material is licensed pursuant to parts 40, 60, 63, 
or 70 of this chapter or an Agreement State license.
* * * * *

    Dated at Rockville, Maryland, this 23rd day of October, 2001.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 01-27157 Filed 11-1-01; 8:45 am]
BILLING CODE 7590-01-P